To the Editor: I was excited to see that in the latest issue of Federal Practitioner there is an article titled “Unrelated Death After Colorectal Cancer Screening: Implications for Improving Colonoscopy Referrals.”¹ In fact, it made the cover! But your cover image showed what appears to be an ancient (an ancient artifact, perhaps)—did I mention ancient?—fiber-optic endoscope. Fiber-optic endoscopes haven’t been used in maybe 20 years. High-definition endoscopy is the standard of care. Before that it was standard definition. The cover image suggests that federal endoscopists may be using museum-quality colonoscopes, which I know is not the case. I just wanted to point out what I found to be humorous.

Thank you for opportunity to share my opinion.

CDR R. Daniel Lawson, MD, MC, USN
Head, Endoscopy
Naval Medical Center San Diego
Owner, Lawson GI LLC
Gastroenterologist

Response: Dr. Lawson, thank you for your concern. The image in question was selected by myself and the art director and not the authors of the article in question, purely for its recognizable and iconic nature. The image was in no way meant to portray the current state of the technology used at federal facilities. We regret that it may have confused or misled any readers about the current standard of endoscopy care. In the future we will retire such images to the museums where they belong.

Reid A. Paul, MA
Editor

To the Editor: I was excited to see that in the latest issue of Federal Practitioner there is an article titled “Unrelated Death After Colorectal Cancer Screening: Implications for Improving Colonoscopy Referrals.”¹ In fact, it made the cover! But your cover image showed what appears to be an ancient (an ancient artifact, perhaps)—did I mention ancient?—fiber-optic endoscope. Fiber-optic endoscopes haven’t been used in maybe 20 years. High-definition endoscopy is the standard of care. Before that it was standard definition. The cover image suggests that federal endoscopists may be using museum-quality colonoscopes, which I know is not the case. I just wanted to point out what I found to be humorous.

Thank you for opportunity to share my opinion.

CDR R. Daniel Lawson, MD, MC, USN
Head, Endoscopy
Naval Medical Center San Diego
Owner, Lawson GI LLC
Gastroenterologist

Response: Dr. Lawson, thank you for your concern. The image in question was selected by myself and the art director and not the authors of the article in question, purely for its recognizable and iconic nature. The image was in no way meant to portray the current state of the technology used at federal facilities. We regret that it may have confused or misled any readers about the current standard of endoscopy care. In the future we will retire such images to the museums where they belong.

Reid A. Paul, MA
Editor

To the Editor: I was excited to see that in the latest issue of Federal Practitioner there is an article titled “Unrelated Death After Colorectal Cancer Screening: Implications for Improving Colonoscopy Referrals.”¹ In fact, it made the cover! But your cover image showed what appears to be an ancient (an ancient artifact, perhaps)—did I mention ancient?—fiber-optic endoscope. Fiber-optic endoscopes haven’t been used in maybe 20 years. High-definition endoscopy is the standard of care. Before that it was standard definition. The cover image suggests that federal endoscopists may be using museum-quality colonoscopes, which I know is not the case. I just wanted to point out what I found to be humorous.

Thank you for opportunity to share my opinion.

CDR R. Daniel Lawson, MD, MC, USN
Head, Endoscopy
Naval Medical Center San Diego
Owner, Lawson GI LLC
Gastroenterologist

Response: Dr. Lawson, thank you for your concern. The image in question was selected by myself and the art director and not the authors of the article in question, purely for its recognizable and iconic nature. The image was in no way meant to portray the current state of the technology used at federal facilities. We regret that it may have confused or misled any readers about the current standard of endoscopy care. In the future we will retire such images to the museums where they belong.

Reid A. Paul, MA
Editor

Whoever seeks to set one religion against another seeks to destroy all religion.¹
President Franklin D. Roosevelt

Recently, a US Department of Veterans Affairs (VA) colleague knowing of my background in religious studies asked me what I thought of the recent change in VA religious policy. VA Secretary Robert Wilke had announced on July 3 that VA was revising its policies on religious symbols at all VA facilities and religious and pastoral care in the Veterans Health Administration, respectively.^2,3 A news release from the VA Office of Public and Intergovernmental Affairs designated the changes as an “overhaul.”⁴

The revisions in these VA directives are designed to address confusion and inconsistency regarding displays of religious matters, not just between different VA medical centers (VAMCs) but even within a single facility. From my decades as a federal practitioner and ethicist, I can attest to the confusion. I have heard or read from staff and leaders of VAMCs everything from “VA prohibits all religious symbols so take that Christmas tree down” to “it is fine to host holiday parties complete with decorations.” There certainly was a need for clarity, transparency, and fairness in VA policy regarding religious and spiritual symbolism. This editorial will discuss how, why, and whether the policy accomplishes this organizational ethics purpose.

The new policies have 3 aims: (1) to permit VA facilities to publicly display religious content in appropriate circumstances; (2) to allow patients and their guests to request and receive religious literature, sacred texts, and spiritual symbols during visits to VA chapels or episodes of treatment; and (3) to permit VA facilities to receive and dispense donations of religious literature, cards, and symbols to VA patrons under appropriate circumstances or when they ask for them.

Secretary Wilke announced the aim of the revised directives: “These important changes will bring simplicity and clarity to our policies governing religious and spiritual symbols, helping ensure we are consistently complying with the First Amendment to the US Constitution at thousands of facilities across the department.”⁴ As with most US Department of Defense (DoD) and VA decisions about potentially controversial issues, this one has a backstory involving 2 high-profile court cases that provide a deeper understanding of the subtext of the policy change.

In February 2019, the US Supreme Court heard oral arguments for The American Legion v American Humanist Association, the most recent of a long line of important cases about the First Amendment and its freedom of religion guarantee.⁵ This case involved veterans—although not the VA or DoD—and is of prima facie interest for those invested or interested in the VA’s position on religion. A 40-foot cross had stood in a veteran memorial park in Bladensburg, Maryland, for decades. In the 1960s the park became the property of the Maryland National Capital Park and Planning Commission (MNCPPC), which assumed the responsibility for upkeep for the cross at considerable expense. The American Humanist Association, an organization advocating for church-state separation, sued the MNCPPC on the grounds it violated the establishment clause of the First Amendment by promoting Christianity as a federally supported religion.

The US District Court found in favor of MNCPPC, but an appeals court reversed that decision. The American Legion, a major force in VA politics, joined MNCPPC to appeal the case to the Supreme Court. The Court issued a 7 to 2 decision, which ruled that the cross did not violate the establishment clause. Even though the cross began as religious symbol, with the passage of time the High Court opined that the cross had become a historic memorial honoring those who fought in the First World War, which rose above its purely Christian meaning.⁵

The American Legion website explicitly credited their success before the Supreme Court as the impetus for VA policy changes.⁶ Hence, from the perspective of VA leadership, this wider latitude for religious expression, which the revised policy now allows, renderings VA practice consonant with the authoritative interpreters of constitutional law—the highest court in the land.

Of course, on a question that has been so divisive for the nation since its founding, there are many who protest this extension of religious liberty in the federal health care system. Veterans stand tall on both sides of this divide. In May 2019 a US Air Force veteran filed a federal lawsuit against the Manchester VAMC director asking the court to remove a Christian Bible from a public display.⁷ With echoes of the Maryland cross case, the Bible in question was owned by a World War II prisoner of war (POW) and sat on a missing man remembrance table for all POWs in the lobby of the facility. Following complaints, the Bible was initially removed but was then returned after complaints over the removal.

Air Force Times compared the resulting melee to actual combat!⁷ As with the first case, such legal battles are ripe territory for advocacy and lobbying organizations of all political stripes to weigh in while promoting their own ideologic agendas. The Military Religious Freedom Foundation assumed the mantle on behalf of the Air Force veteran in the Manchester suit. The news media reported that the plaintiff in the case identified himself as a committed Christian. According to the news reports, what worried this veteran was the same thing that troubled President Roosevelt in 1940: By featuring the Christian Bible, the VA excluded other faith groups.¹ Other veterans and some veteran religious organizations objected just as strenuously to its removal, likely done to reduce potential for violence. Veterans opposing the inclusion of the Bible in the display also grounded their arguments in the First Amendment clause that prohibits the federal government from establishing or favoring any religion.⁸

Presumptively, displays of such religious symbols may well be supported in VA policy as a protected expression of religion, which Secretary Wilke stated was the other primary aim of the revisions. “We want to make sure that all of our veterans and their families feel welcome at VA, no matter their religious beliefs. Protecting religious liberty is a key part of how we accomplish that goal.”⁴

In the middle of this sensitive controversy are the many veterans and their families that third parties—for profit, for politics, for publicity—have far too often manipulated for their own purposes. If you want to get an idea of the scope of these diverse stakeholders, just peruse the amicus briefs submitted to the Supreme Court on both sides of the issues in The American Legion v American Humanist Association.⁸

VA data show that veterans while being more religious than the general public are religiously diverse: 2015 data on the religion of veterans in every state listed 13 different faith communities.⁹ My response to the colleague who asked me about my opinion of the VA policies changes was based on the background narrative recounted here. My rsponse, in light of Roosevelt’s concern and this snippet of a much larger swath of legal machinations, is the change in the VA policy is reasonable as long as it “has room for the expression of those whose trust is in God, in country, in neither, and in both.” We know from research that religion is a strength and a support to many veterans and that spirituality as an aspect of psychological therapies and pastoral counseling has shown healing power for the wounds of war.¹⁰ Yet we also know that religiously based hatred and discrimination are among the most divisive and destructive forces that threaten our democracy. Let’s all hope—and those who pray do so—that these policy changes deter the latter and promote the former.

Whoever seeks to set one religion against another seeks to destroy all religion.¹
President Franklin D. Roosevelt

Recently, a US Department of Veterans Affairs (VA) colleague knowing of my background in religious studies asked me what I thought of the recent change in VA religious policy. VA Secretary Robert Wilke had announced on July 3 that VA was revising its policies on religious symbols at all VA facilities and religious and pastoral care in the Veterans Health Administration, respectively.^2,3 A news release from the VA Office of Public and Intergovernmental Affairs designated the changes as an “overhaul.”⁴

The revisions in these VA directives are designed to address confusion and inconsistency regarding displays of religious matters, not just between different VA medical centers (VAMCs) but even within a single facility. From my decades as a federal practitioner and ethicist, I can attest to the confusion. I have heard or read from staff and leaders of VAMCs everything from “VA prohibits all religious symbols so take that Christmas tree down” to “it is fine to host holiday parties complete with decorations.” There certainly was a need for clarity, transparency, and fairness in VA policy regarding religious and spiritual symbolism. This editorial will discuss how, why, and whether the policy accomplishes this organizational ethics purpose.

The new policies have 3 aims: (1) to permit VA facilities to publicly display religious content in appropriate circumstances; (2) to allow patients and their guests to request and receive religious literature, sacred texts, and spiritual symbols during visits to VA chapels or episodes of treatment; and (3) to permit VA facilities to receive and dispense donations of religious literature, cards, and symbols to VA patrons under appropriate circumstances or when they ask for them.

Secretary Wilke announced the aim of the revised directives: “These important changes will bring simplicity and clarity to our policies governing religious and spiritual symbols, helping ensure we are consistently complying with the First Amendment to the US Constitution at thousands of facilities across the department.”⁴ As with most US Department of Defense (DoD) and VA decisions about potentially controversial issues, this one has a backstory involving 2 high-profile court cases that provide a deeper understanding of the subtext of the policy change.

In February 2019, the US Supreme Court heard oral arguments for The American Legion v American Humanist Association, the most recent of a long line of important cases about the First Amendment and its freedom of religion guarantee.⁵ This case involved veterans—although not the VA or DoD—and is of prima facie interest for those invested or interested in the VA’s position on religion. A 40-foot cross had stood in a veteran memorial park in Bladensburg, Maryland, for decades. In the 1960s the park became the property of the Maryland National Capital Park and Planning Commission (MNCPPC), which assumed the responsibility for upkeep for the cross at considerable expense. The American Humanist Association, an organization advocating for church-state separation, sued the MNCPPC on the grounds it violated the establishment clause of the First Amendment by promoting Christianity as a federally supported religion.

The US District Court found in favor of MNCPPC, but an appeals court reversed that decision. The American Legion, a major force in VA politics, joined MNCPPC to appeal the case to the Supreme Court. The Court issued a 7 to 2 decision, which ruled that the cross did not violate the establishment clause. Even though the cross began as religious symbol, with the passage of time the High Court opined that the cross had become a historic memorial honoring those who fought in the First World War, which rose above its purely Christian meaning.⁵

The American Legion website explicitly credited their success before the Supreme Court as the impetus for VA policy changes.⁶ Hence, from the perspective of VA leadership, this wider latitude for religious expression, which the revised policy now allows, renderings VA practice consonant with the authoritative interpreters of constitutional law—the highest court in the land.

Of course, on a question that has been so divisive for the nation since its founding, there are many who protest this extension of religious liberty in the federal health care system. Veterans stand tall on both sides of this divide. In May 2019 a US Air Force veteran filed a federal lawsuit against the Manchester VAMC director asking the court to remove a Christian Bible from a public display.⁷ With echoes of the Maryland cross case, the Bible in question was owned by a World War II prisoner of war (POW) and sat on a missing man remembrance table for all POWs in the lobby of the facility. Following complaints, the Bible was initially removed but was then returned after complaints over the removal.

Air Force Times compared the resulting melee to actual combat!⁷ As with the first case, such legal battles are ripe territory for advocacy and lobbying organizations of all political stripes to weigh in while promoting their own ideologic agendas. The Military Religious Freedom Foundation assumed the mantle on behalf of the Air Force veteran in the Manchester suit. The news media reported that the plaintiff in the case identified himself as a committed Christian. According to the news reports, what worried this veteran was the same thing that troubled President Roosevelt in 1940: By featuring the Christian Bible, the VA excluded other faith groups.¹ Other veterans and some veteran religious organizations objected just as strenuously to its removal, likely done to reduce potential for violence. Veterans opposing the inclusion of the Bible in the display also grounded their arguments in the First Amendment clause that prohibits the federal government from establishing or favoring any religion.⁸

Presumptively, displays of such religious symbols may well be supported in VA policy as a protected expression of religion, which Secretary Wilke stated was the other primary aim of the revisions. “We want to make sure that all of our veterans and their families feel welcome at VA, no matter their religious beliefs. Protecting religious liberty is a key part of how we accomplish that goal.”⁴

In the middle of this sensitive controversy are the many veterans and their families that third parties—for profit, for politics, for publicity—have far too often manipulated for their own purposes. If you want to get an idea of the scope of these diverse stakeholders, just peruse the amicus briefs submitted to the Supreme Court on both sides of the issues in The American Legion v American Humanist Association.⁸

VA data show that veterans while being more religious than the general public are religiously diverse: 2015 data on the religion of veterans in every state listed 13 different faith communities.⁹ My response to the colleague who asked me about my opinion of the VA policies changes was based on the background narrative recounted here. My rsponse, in light of Roosevelt’s concern and this snippet of a much larger swath of legal machinations, is the change in the VA policy is reasonable as long as it “has room for the expression of those whose trust is in God, in country, in neither, and in both.” We know from research that religion is a strength and a support to many veterans and that spirituality as an aspect of psychological therapies and pastoral counseling has shown healing power for the wounds of war.¹⁰ Yet we also know that religiously based hatred and discrimination are among the most divisive and destructive forces that threaten our democracy. Let’s all hope—and those who pray do so—that these policy changes deter the latter and promote the former.

Whoever seeks to set one religion against another seeks to destroy all religion.¹
President Franklin D. Roosevelt

Recently, a US Department of Veterans Affairs (VA) colleague knowing of my background in religious studies asked me what I thought of the recent change in VA religious policy. VA Secretary Robert Wilke had announced on July 3 that VA was revising its policies on religious symbols at all VA facilities and religious and pastoral care in the Veterans Health Administration, respectively.^2,3 A news release from the VA Office of Public and Intergovernmental Affairs designated the changes as an “overhaul.”⁴

The revisions in these VA directives are designed to address confusion and inconsistency regarding displays of religious matters, not just between different VA medical centers (VAMCs) but even within a single facility. From my decades as a federal practitioner and ethicist, I can attest to the confusion. I have heard or read from staff and leaders of VAMCs everything from “VA prohibits all religious symbols so take that Christmas tree down” to “it is fine to host holiday parties complete with decorations.” There certainly was a need for clarity, transparency, and fairness in VA policy regarding religious and spiritual symbolism. This editorial will discuss how, why, and whether the policy accomplishes this organizational ethics purpose.

The new policies have 3 aims: (1) to permit VA facilities to publicly display religious content in appropriate circumstances; (2) to allow patients and their guests to request and receive religious literature, sacred texts, and spiritual symbols during visits to VA chapels or episodes of treatment; and (3) to permit VA facilities to receive and dispense donations of religious literature, cards, and symbols to VA patrons under appropriate circumstances or when they ask for them.

Secretary Wilke announced the aim of the revised directives: “These important changes will bring simplicity and clarity to our policies governing religious and spiritual symbols, helping ensure we are consistently complying with the First Amendment to the US Constitution at thousands of facilities across the department.”⁴ As with most US Department of Defense (DoD) and VA decisions about potentially controversial issues, this one has a backstory involving 2 high-profile court cases that provide a deeper understanding of the subtext of the policy change.

In February 2019, the US Supreme Court heard oral arguments for The American Legion v American Humanist Association, the most recent of a long line of important cases about the First Amendment and its freedom of religion guarantee.⁵ This case involved veterans—although not the VA or DoD—and is of prima facie interest for those invested or interested in the VA’s position on religion. A 40-foot cross had stood in a veteran memorial park in Bladensburg, Maryland, for decades. In the 1960s the park became the property of the Maryland National Capital Park and Planning Commission (MNCPPC), which assumed the responsibility for upkeep for the cross at considerable expense. The American Humanist Association, an organization advocating for church-state separation, sued the MNCPPC on the grounds it violated the establishment clause of the First Amendment by promoting Christianity as a federally supported religion.

The US District Court found in favor of MNCPPC, but an appeals court reversed that decision. The American Legion, a major force in VA politics, joined MNCPPC to appeal the case to the Supreme Court. The Court issued a 7 to 2 decision, which ruled that the cross did not violate the establishment clause. Even though the cross began as religious symbol, with the passage of time the High Court opined that the cross had become a historic memorial honoring those who fought in the First World War, which rose above its purely Christian meaning.⁵

The American Legion website explicitly credited their success before the Supreme Court as the impetus for VA policy changes.⁶ Hence, from the perspective of VA leadership, this wider latitude for religious expression, which the revised policy now allows, renderings VA practice consonant with the authoritative interpreters of constitutional law—the highest court in the land.

Of course, on a question that has been so divisive for the nation since its founding, there are many who protest this extension of religious liberty in the federal health care system. Veterans stand tall on both sides of this divide. In May 2019 a US Air Force veteran filed a federal lawsuit against the Manchester VAMC director asking the court to remove a Christian Bible from a public display.⁷ With echoes of the Maryland cross case, the Bible in question was owned by a World War II prisoner of war (POW) and sat on a missing man remembrance table for all POWs in the lobby of the facility. Following complaints, the Bible was initially removed but was then returned after complaints over the removal.

Air Force Times compared the resulting melee to actual combat!⁷ As with the first case, such legal battles are ripe territory for advocacy and lobbying organizations of all political stripes to weigh in while promoting their own ideologic agendas. The Military Religious Freedom Foundation assumed the mantle on behalf of the Air Force veteran in the Manchester suit. The news media reported that the plaintiff in the case identified himself as a committed Christian. According to the news reports, what worried this veteran was the same thing that troubled President Roosevelt in 1940: By featuring the Christian Bible, the VA excluded other faith groups.¹ Other veterans and some veteran religious organizations objected just as strenuously to its removal, likely done to reduce potential for violence. Veterans opposing the inclusion of the Bible in the display also grounded their arguments in the First Amendment clause that prohibits the federal government from establishing or favoring any religion.⁸

Presumptively, displays of such religious symbols may well be supported in VA policy as a protected expression of religion, which Secretary Wilke stated was the other primary aim of the revisions. “We want to make sure that all of our veterans and their families feel welcome at VA, no matter their religious beliefs. Protecting religious liberty is a key part of how we accomplish that goal.”⁴

In the middle of this sensitive controversy are the many veterans and their families that third parties—for profit, for politics, for publicity—have far too often manipulated for their own purposes. If you want to get an idea of the scope of these diverse stakeholders, just peruse the amicus briefs submitted to the Supreme Court on both sides of the issues in The American Legion v American Humanist Association.⁸

VA data show that veterans while being more religious than the general public are religiously diverse: 2015 data on the religion of veterans in every state listed 13 different faith communities.⁹ My response to the colleague who asked me about my opinion of the VA policies changes was based on the background narrative recounted here. My rsponse, in light of Roosevelt’s concern and this snippet of a much larger swath of legal machinations, is the change in the VA policy is reasonable as long as it “has room for the expression of those whose trust is in God, in country, in neither, and in both.” We know from research that religion is a strength and a support to many veterans and that spirituality as an aspect of psychological therapies and pastoral counseling has shown healing power for the wounds of war.¹⁰ Yet we also know that religiously based hatred and discrimination are among the most divisive and destructive forces that threaten our democracy. Let’s all hope—and those who pray do so—that these policy changes deter the latter and promote the former.

A 73-year-old male veteran with a history of ischemic stroke with left-sided deficits and edema, falls, poorly controlled hypertension, active tobacco use, obesity, and prediabetes was assessed on a routine visit by our home-based primary care team and found to have a new, unilateral, asymptomatic rash. He reported feeling no pain in the affected area or any significant increase in the baseline left lower extremity edema and weakness resulting from his stroke 2 years prior.

On the left lateral leg from mid-thigh to mid-calf, there was a nontender, flat, reticulated rash with pigmentary alteration ranging from light brown to dark brown (Figure).

On further questioning, the patient reported regular use of a space heater because his gas furnace had been destroyed in an earthquake more than 20 years before. He would place this heater close to his left leg when using the computer or while sleeping in his wheelchair.

• What is your diagnosis?
• How would you treat this patient?

Our Diagnosis

Erythema ab igne, also called hot water bottle rash, is a clinical diagnosis based on characteristic cutaneous findings and a clear history of chronic, moderate heat or infrared exposure.¹ Although exposure to space heaters, open fire, radiators, hot water bottles, and heating pads are the classic causes, recently there have been reports of laptop computers, cell phones, infrared food lamps, automobile seat heaters, and heated recliners causing the same type of skin reaction.²

With chronic moderate heat or infrared exposure, the rash usually progresses over days to months. It begins as a mild, transient, reticulated, erythematous rash, which follows the pattern of the cutaneous venous plexus and resolves minutes to hours after removal of the offending source as vasodilation resolves. After months of continued exposure, the dermis around the affected vasculature eventually becomes hyperpigmented due to the deposition of melanin and sometimes hemosiderin.

The rash is usually asymptomatic but has been associated with pain, pruritis, and/or tingling. Once the diagnosis is made, treatment involves removal of the offending source. The discoloration may resolve over months to years, but permanent hyperpigmentation is not uncommon. There are a few case reports on treatment using Nd-Yag laser therapy, topical hydroquinone and tretinoin, 5-fluorouracil, and systemic mesoglycan with topical bioflavonoids.^2-4

While the prognosis of erythema ab igne is excellent if detected early, failure to recognize this condition and remove the offending source can lead to sequalae, such as squamous cell carcinoma, poorly differentiated carcinoma, cutaneous marginal zone lymphoma, and Merkel cell carcinoma.^5-8 Development of malignancy typically has a latency period of > 30 years. Patients should have periodic surveillance of their skin and any suspicious lesion in the involved area should be considered for biopsy.

Rashes may represent systemic or more localized pathology (Table). In contrast to erythema ab igne, the rash associated with a vasculitic process (autoimmune, drug-induced, or infectious) tends to be more generalized and bilateral but still follows the pattern of the cutaneous venous plexus. An example of this would be livedo reticularis. Although this rash is reticular, it is not hyperpigmented.⁹ A variant of livedo reticularis is cutis marmorata, which develops in response to cold exposure, particularly in infants or in the setting of hypothyroidism.Cutis marmorata is erythematous, blanchable, and reversible with rewarming. Unlike erythema ab igne, there is no hyperpigmentation and tends to be more diffuse.¹⁰ 

When evaluating a reticular rash, consider local and systemic etiologies. If more localized and hyperpigmented, ask about heat or infrared exposure. This may point to a diagnosis of erythema ab igne.

A 73-year-old male veteran with a history of ischemic stroke with left-sided deficits and edema, falls, poorly controlled hypertension, active tobacco use, obesity, and prediabetes was assessed on a routine visit by our home-based primary care team and found to have a new, unilateral, asymptomatic rash. He reported feeling no pain in the affected area or any significant increase in the baseline left lower extremity edema and weakness resulting from his stroke 2 years prior.

On the left lateral leg from mid-thigh to mid-calf, there was a nontender, flat, reticulated rash with pigmentary alteration ranging from light brown to dark brown (Figure).

On further questioning, the patient reported regular use of a space heater because his gas furnace had been destroyed in an earthquake more than 20 years before. He would place this heater close to his left leg when using the computer or while sleeping in his wheelchair.

• What is your diagnosis?
• How would you treat this patient?

Our Diagnosis

Erythema ab igne, also called hot water bottle rash, is a clinical diagnosis based on characteristic cutaneous findings and a clear history of chronic, moderate heat or infrared exposure.¹ Although exposure to space heaters, open fire, radiators, hot water bottles, and heating pads are the classic causes, recently there have been reports of laptop computers, cell phones, infrared food lamps, automobile seat heaters, and heated recliners causing the same type of skin reaction.²

With chronic moderate heat or infrared exposure, the rash usually progresses over days to months. It begins as a mild, transient, reticulated, erythematous rash, which follows the pattern of the cutaneous venous plexus and resolves minutes to hours after removal of the offending source as vasodilation resolves. After months of continued exposure, the dermis around the affected vasculature eventually becomes hyperpigmented due to the deposition of melanin and sometimes hemosiderin.

The rash is usually asymptomatic but has been associated with pain, pruritis, and/or tingling. Once the diagnosis is made, treatment involves removal of the offending source. The discoloration may resolve over months to years, but permanent hyperpigmentation is not uncommon. There are a few case reports on treatment using Nd-Yag laser therapy, topical hydroquinone and tretinoin, 5-fluorouracil, and systemic mesoglycan with topical bioflavonoids.^2-4

While the prognosis of erythema ab igne is excellent if detected early, failure to recognize this condition and remove the offending source can lead to sequalae, such as squamous cell carcinoma, poorly differentiated carcinoma, cutaneous marginal zone lymphoma, and Merkel cell carcinoma.^5-8 Development of malignancy typically has a latency period of > 30 years. Patients should have periodic surveillance of their skin and any suspicious lesion in the involved area should be considered for biopsy.

Rashes may represent systemic or more localized pathology (Table). In contrast to erythema ab igne, the rash associated with a vasculitic process (autoimmune, drug-induced, or infectious) tends to be more generalized and bilateral but still follows the pattern of the cutaneous venous plexus. An example of this would be livedo reticularis. Although this rash is reticular, it is not hyperpigmented.⁹ A variant of livedo reticularis is cutis marmorata, which develops in response to cold exposure, particularly in infants or in the setting of hypothyroidism.Cutis marmorata is erythematous, blanchable, and reversible with rewarming. Unlike erythema ab igne, there is no hyperpigmentation and tends to be more diffuse.¹⁰ 

When evaluating a reticular rash, consider local and systemic etiologies. If more localized and hyperpigmented, ask about heat or infrared exposure. This may point to a diagnosis of erythema ab igne.

A 73-year-old male veteran with a history of ischemic stroke with left-sided deficits and edema, falls, poorly controlled hypertension, active tobacco use, obesity, and prediabetes was assessed on a routine visit by our home-based primary care team and found to have a new, unilateral, asymptomatic rash. He reported feeling no pain in the affected area or any significant increase in the baseline left lower extremity edema and weakness resulting from his stroke 2 years prior.

On the left lateral leg from mid-thigh to mid-calf, there was a nontender, flat, reticulated rash with pigmentary alteration ranging from light brown to dark brown (Figure).

On further questioning, the patient reported regular use of a space heater because his gas furnace had been destroyed in an earthquake more than 20 years before. He would place this heater close to his left leg when using the computer or while sleeping in his wheelchair.

• What is your diagnosis?
• How would you treat this patient?

Our Diagnosis

Erythema ab igne, also called hot water bottle rash, is a clinical diagnosis based on characteristic cutaneous findings and a clear history of chronic, moderate heat or infrared exposure.¹ Although exposure to space heaters, open fire, radiators, hot water bottles, and heating pads are the classic causes, recently there have been reports of laptop computers, cell phones, infrared food lamps, automobile seat heaters, and heated recliners causing the same type of skin reaction.²

With chronic moderate heat or infrared exposure, the rash usually progresses over days to months. It begins as a mild, transient, reticulated, erythematous rash, which follows the pattern of the cutaneous venous plexus and resolves minutes to hours after removal of the offending source as vasodilation resolves. After months of continued exposure, the dermis around the affected vasculature eventually becomes hyperpigmented due to the deposition of melanin and sometimes hemosiderin.

The rash is usually asymptomatic but has been associated with pain, pruritis, and/or tingling. Once the diagnosis is made, treatment involves removal of the offending source. The discoloration may resolve over months to years, but permanent hyperpigmentation is not uncommon. There are a few case reports on treatment using Nd-Yag laser therapy, topical hydroquinone and tretinoin, 5-fluorouracil, and systemic mesoglycan with topical bioflavonoids.^2-4

While the prognosis of erythema ab igne is excellent if detected early, failure to recognize this condition and remove the offending source can lead to sequalae, such as squamous cell carcinoma, poorly differentiated carcinoma, cutaneous marginal zone lymphoma, and Merkel cell carcinoma.^5-8 Development of malignancy typically has a latency period of > 30 years. Patients should have periodic surveillance of their skin and any suspicious lesion in the involved area should be considered for biopsy.

Rashes may represent systemic or more localized pathology (Table). In contrast to erythema ab igne, the rash associated with a vasculitic process (autoimmune, drug-induced, or infectious) tends to be more generalized and bilateral but still follows the pattern of the cutaneous venous plexus. An example of this would be livedo reticularis. Although this rash is reticular, it is not hyperpigmented.⁹ A variant of livedo reticularis is cutis marmorata, which develops in response to cold exposure, particularly in infants or in the setting of hypothyroidism.Cutis marmorata is erythematous, blanchable, and reversible with rewarming. Unlike erythema ab igne, there is no hyperpigmentation and tends to be more diffuse.¹⁰ 

When evaluating a reticular rash, consider local and systemic etiologies. If more localized and hyperpigmented, ask about heat or infrared exposure. This may point to a diagnosis of erythema ab igne.

Localized reactions and transient pain at the site of vaccine administration are frequent and well-described occurrences that are typically short-lived and mild in nature. The most common findings at the injection site are soreness, erythema, and edema.¹ Although less common, generalized shoulder dysfunction after vaccine administration also has been reported. Bodor and colleagues described a peri-articular inflammatory response that led to shoulder pain and weakness.² A single case report by Kuether and colleagues described atraumatic osteonecrosis of the humeral head after H1N1 vaccine administration in the deltoid.³ In 2010, shoulder injury related to vaccine administration (SIRVA) was described by Atanasoff and colleagues as the rapid onset of shoulder pain and dysfunction persisting as a complication of deltoid muscle vaccination in a case series of 13 patients.⁴ In our report, we present a case of an active-duty male eventually diagnosed with SIRVA after influenza vaccination and discuss factors that may prevent vaccine-related shoulder injuries.

Case Presentation

A 31-year-old active-duty male presented to the Allergy clinic for evaluation of persistent left shoulder pain and decreased range of motion (ROM) following influenza vaccination 4 months prior. He reported a history of chronic low back and right shoulder pain. Although the patient had a traumatic injury to his right shoulder, which was corrected with surgery, he had no surgeries on the left shoulder. He reported no prior pain or known trauma to his left shoulder. He had no personal or family history of atopy or vaccine reactions.

The patient weighed 91 kg and received an intramuscular (IM) quadrivalent influenza vaccine with a 25-gauge, 1-inch needle during a mass influenza immunization. He recalled that the site of vaccination was slightly more than 3 cm below the top of the shoulder in a region correlating to the left deltoid. The vaccine was administered while he was standing with his arm extended, adducted, and internally rotated. The patient experienced intense pain immediately after the vaccination and noted decreased ROM. Initially, he dismissed the pain and decreased ROM as routine but sought medical attention when there was no improvement after 3 weeks.

Six weeks after the onset of symptoms, a magnetic resonance image (MRI) revealed tendinopathy of the left distal subscapularis, infraspinatus, supraspinatus, and teres minor tendon. These findings were suggestive of a small partial thickness tear of the supraspinatus (Figure 1), possible calcific tendinopathy of the distal teres minor (Figure 2), and underlying humeral head edema (Figure 3). The patient was evaluated by Orthopedics and experienced no relief from ibuprofen, celecoxib, and a steroid/lidocaine intra-articular injection. Laboratory studies included an unremarkable complete blood count and erythrocyte sedimentation rate. He was diagnosed with SIRVA and continued in physical therapy with incomplete resolution of symptoms 6 months postvaccination.

Discussion

According to a 2018 report issued by the Centers for Disease Control and Prevention, local reactions following immunizations are seen in up to 80% of administered vaccine doses.¹ While most of these reactions are mild, transient, cutaneous reactions, rarely these also may persist and impact quality of life significantly. SIRVA is one such process that can lead to persistent musculoskeletal dysfunction. SIRVA presents as shoulder pain and limited ROM that occurs after the administration of an injectable vaccine. In 2011, the Institute of Medicine determined that evidence supported a causal relationship between vaccine administration and deltoid bursitis.⁵

In 2017, SIRVA was included in the Vaccine Injury Compensation Program (VICP), a federal program that can provide compensation to individuals injured by certain vaccines.⁶ A diagnosis of SIRVA can be considered in patients who experience pain within 48 hours of vaccination, have no prior history of pain or dysfunction of the affected shoulder prior to vaccine administration, and have symptoms limited to the shoulder in which the vaccine was administered where no other abnormality is present to explain these symptoms (eg, brachial neuritis, other neuropathy). Currently, patients with back pain or musculoskeletal complaints that do not include the shoulder following deltoid vaccination do not meet the reporting criteria for SIRVA in the VICP.⁶

The exact prevalence or incidence of SIRVA is unknown. In a 2017 systematic review of the literature and the Spanish Pharmacovigilance System database, Martín Arias and colleagues found 45 cases of new onset, unilateral shoulder dysfunction without associated neuropathy or autoimmune conditions following vaccine administration. They noted a female to male predominance (71.1% vs 28.9%) with a mean age of 53.6 years (range 22-89 y). Most of the cases occurred following influenza vaccine (62%); pneumococcal vaccine was the next most common (13%).⁷ Shoulder injury also has been reported after tetanus-diphtheria toxoids, human papilloma virus, and hepatitis A virus vaccines.^4,7 The review noted that all patients had onset of pain within the first week following vaccination with the majority (81%) having pain in the first 24 hours. Two cases found in the Spanish database had pain onset 2 months postvaccination.⁷ Atanasoff and colleagues found that 93% of patients had pain onset within 24 hours of vaccination with 54% reporting immediate pain.⁴

The Vaccine Adverse Event Reporting System (VAERS) tracks reports of shoulder dysfunction following certain vaccinations, but the system is unable to establish causality. According to VAERS reporting, between 2010 and 2016, there were 1006 possible reports of shoulder dysfunction following inactivated influenza vaccination (IIV) compared with an estimated 130 million doses of IIV given each influenza season in the US.⁸

Bodor and Montalvo postulated that vaccine antigen was being over penetrated into the synovial space of the shoulder, as the subdeltoid/subacromial bursa is located a mere 0.8 to 1.6 cm below the skin surface in patients with healthy body mass index.² Atanasoff and colleagues expounded that antibodies from previous vaccination or natural infection may then form antigen-antibody complexes, creating prolonged local immune and inflammatory responses leading to bursitis or tendonitis.⁴ Martín Arias and colleagues hypothesized that improper injection technique, including wrong insertion angle, incorrect needle type/size, and failure to account for the patient’s physical characteristics were the most likely causes of SIRVA.⁷

Proper vaccine administration ensures that vaccinations are delivered in a safe and efficacious manner. Safe vaccination practices include the use of trained personnel who receive comprehensive, competency-based training regarding vaccine administration.¹ Aspiration prior to an injection is a practice that has not been evaluated fully. Given that the 2 routinely recommended locations for IM vaccines (deltoid muscle in adults or vastus lateralis muscle in infants) lack large blood vessels, the practice of aspiration prior to an IM vaccine is not currently deemed necessary.¹ Additional safe vaccine practices include the selection of appropriate needle length for muscle penetration and that anatomic landmarks determine the location of vaccination.¹ Despite this, in a survey of 100 medical professionals, half could not name any structure at risk from improper deltoid vaccination technique.⁹

Cook and colleagues used anthropomorphic data to evaluate the potential for injury to the subdeltoid/subacromial bursa and/or the axillary nerve.¹⁰ Based on these data, they recommended safe IM vaccine administration can be assured by using the midpoint of the deltoid muscle located midway between the acromion and deltoid tuberosity with the arm abducted to 60°.^10,11 In 46% of SIRVA cases described by Atanasoff and colleagues, patients reported that the vaccine was administered “too high.”⁴ The study also recommended that the clinician and the patient be in the seated position to ensure proper needle angle and location of administration.⁴ For most adults, a 1-inch needle is appropriate for vaccine administration in the deltoid; however, in females weighing < 70 kg and males < 75 kg, a 5/8-inch needle is recommended to avoid injury.⁷

Our 91-kg patient was appropriately administered his vaccine with a 1-inch needle. As he experienced immediate pain, it is unlikely that his symptoms were due to an immune-mediated process, as this would not be expected to occur immediately. Improper location of vaccine administration is a proposed mechanism of injury for our patient, though this cannot be confirmed by history alone. His prior history of traumatic injury to the opposite shoulder could represent a confounding factor as no prior imaging was available for the vaccine-affected shoulder. A preexisting shoulder abnormality or injury cannot be completely excluded, and it is possible that an underlying prior shoulder injury was aggravated postvaccination.

Evaluation and Treatment

There is no standardized approach for the evaluation of SIRVA to date. Awareness of SIRVA and a high index of suspicion are necessary to evaluate patients with shoulder concerns postvaccination. Laboratory evaluation should be considered to evaluate for other potential diagnoses (eg, infection, rheumatologic concerns). Routine X-rays are not helpful in cases of SIRVA. Ultrasound may be considered as it can show bursa abnormalities consistent with bursitis.² MRI of the affected shoulder may provide improved diagnostic capability if SIRVA is suspected. MRI findings vary but include intraosseous edema, bursitis, tendonitis, and rotator cuff tears.^4,12 Complete rotator cuff tears were found in 15% of cases reviewed by Atanasoff and colleagues.⁴ While there is no recommended timing for MRI, 63% of MRIs were performed within 3 months of symptom onset.⁴ As SIRVA is not a neurologic injury, nerve conduction, electromyographic studies, and neurologic evaluation or testing are expected to be normal.

Treatment of SIRVA and other vaccine-related shoulder injuries typically have involved pain management (eg, nonsteroidal anti-inflammatory agents), intra-articular steroid injections, and physical therapy, though some patients never experience complete resolution of symptoms.^2,4,7 Both patients with vaccination-related shoulder dysfunction described by Bodor and colleagues improved after intra-articular triamcinolone injections, with up to 3 injections before complete resolution of pain in one patient.² Orthopedics evaluation may need to be considered for persistent symptoms. According to Atanasoff and colleagues, most patients were symptomatic for at least 6 months, and complete recovery was seen in less than one-third of patients.⁴ Although the development of SIRVA is not a contraindication to future doses of the presumed causative vaccine, subsequent vaccination should include careful consideration of other administration sites if possible (eg, vastus lateralis may be used for IM injections in adults) (Figure 4).

Reporting

A diagnosis or concern for SIRVA also should be reported to the VAERS, the national database established in order to detect possible safety problems with US-licensed vaccines. VAERS reports can be submitted by anyone with concerns for vaccine adverse reactions, including patients, caregivers, and health care professionals at vaers.hhs.gov/reportevent.html. Additional information regarding VICP can be obtained at www.hrsa.gov/vaccine-compensation/index.html.

Military-Specific Issues

The military values readiness, which includes ensuring that active-duty members remain up-to-date on life-saving vaccinations. Immunization is of critical importance to mobility and success of the overall mission. Mobility processing lines where immunizations can be provided to multiple active-duty members can be a successful strategy for mass immunizations. Although the quick administration of immunizations maintains readiness and provides a medically necessary service, it also may increase the chances of incorrect vaccine placement in the deltoid, causing long-term shoulder immobility that may impact a service member’s retainability. The benefits of mobility processing lines can continue to outweigh the risks of immunization administration by ensuring proper staff training, seating both the administrator and recipient of vaccination, and selecting a proper needle length and site of administration specific to each recipient.

Conclusion

Correct administration of vaccines is of utmost importance in preventing SIRVA and other vaccine-related shoulder dysfunctions. Proper staff training and refresher training can help prevent vaccine-related shoulder injuries. Additionally, clinicians should be aware of this potential complication and maintain a high index of suspicion when evaluating patients with postvaccination shoulder complaints.

Localized reactions and transient pain at the site of vaccine administration are frequent and well-described occurrences that are typically short-lived and mild in nature. The most common findings at the injection site are soreness, erythema, and edema.¹ Although less common, generalized shoulder dysfunction after vaccine administration also has been reported. Bodor and colleagues described a peri-articular inflammatory response that led to shoulder pain and weakness.² A single case report by Kuether and colleagues described atraumatic osteonecrosis of the humeral head after H1N1 vaccine administration in the deltoid.³ In 2010, shoulder injury related to vaccine administration (SIRVA) was described by Atanasoff and colleagues as the rapid onset of shoulder pain and dysfunction persisting as a complication of deltoid muscle vaccination in a case series of 13 patients.⁴ In our report, we present a case of an active-duty male eventually diagnosed with SIRVA after influenza vaccination and discuss factors that may prevent vaccine-related shoulder injuries.

Case Presentation

A 31-year-old active-duty male presented to the Allergy clinic for evaluation of persistent left shoulder pain and decreased range of motion (ROM) following influenza vaccination 4 months prior. He reported a history of chronic low back and right shoulder pain. Although the patient had a traumatic injury to his right shoulder, which was corrected with surgery, he had no surgeries on the left shoulder. He reported no prior pain or known trauma to his left shoulder. He had no personal or family history of atopy or vaccine reactions.

The patient weighed 91 kg and received an intramuscular (IM) quadrivalent influenza vaccine with a 25-gauge, 1-inch needle during a mass influenza immunization. He recalled that the site of vaccination was slightly more than 3 cm below the top of the shoulder in a region correlating to the left deltoid. The vaccine was administered while he was standing with his arm extended, adducted, and internally rotated. The patient experienced intense pain immediately after the vaccination and noted decreased ROM. Initially, he dismissed the pain and decreased ROM as routine but sought medical attention when there was no improvement after 3 weeks.

Six weeks after the onset of symptoms, a magnetic resonance image (MRI) revealed tendinopathy of the left distal subscapularis, infraspinatus, supraspinatus, and teres minor tendon. These findings were suggestive of a small partial thickness tear of the supraspinatus (Figure 1), possible calcific tendinopathy of the distal teres minor (Figure 2), and underlying humeral head edema (Figure 3). The patient was evaluated by Orthopedics and experienced no relief from ibuprofen, celecoxib, and a steroid/lidocaine intra-articular injection. Laboratory studies included an unremarkable complete blood count and erythrocyte sedimentation rate. He was diagnosed with SIRVA and continued in physical therapy with incomplete resolution of symptoms 6 months postvaccination.

Discussion

According to a 2018 report issued by the Centers for Disease Control and Prevention, local reactions following immunizations are seen in up to 80% of administered vaccine doses.¹ While most of these reactions are mild, transient, cutaneous reactions, rarely these also may persist and impact quality of life significantly. SIRVA is one such process that can lead to persistent musculoskeletal dysfunction. SIRVA presents as shoulder pain and limited ROM that occurs after the administration of an injectable vaccine. In 2011, the Institute of Medicine determined that evidence supported a causal relationship between vaccine administration and deltoid bursitis.⁵

In 2017, SIRVA was included in the Vaccine Injury Compensation Program (VICP), a federal program that can provide compensation to individuals injured by certain vaccines.⁶ A diagnosis of SIRVA can be considered in patients who experience pain within 48 hours of vaccination, have no prior history of pain or dysfunction of the affected shoulder prior to vaccine administration, and have symptoms limited to the shoulder in which the vaccine was administered where no other abnormality is present to explain these symptoms (eg, brachial neuritis, other neuropathy). Currently, patients with back pain or musculoskeletal complaints that do not include the shoulder following deltoid vaccination do not meet the reporting criteria for SIRVA in the VICP.⁶

The exact prevalence or incidence of SIRVA is unknown. In a 2017 systematic review of the literature and the Spanish Pharmacovigilance System database, Martín Arias and colleagues found 45 cases of new onset, unilateral shoulder dysfunction without associated neuropathy or autoimmune conditions following vaccine administration. They noted a female to male predominance (71.1% vs 28.9%) with a mean age of 53.6 years (range 22-89 y). Most of the cases occurred following influenza vaccine (62%); pneumococcal vaccine was the next most common (13%).⁷ Shoulder injury also has been reported after tetanus-diphtheria toxoids, human papilloma virus, and hepatitis A virus vaccines.^4,7 The review noted that all patients had onset of pain within the first week following vaccination with the majority (81%) having pain in the first 24 hours. Two cases found in the Spanish database had pain onset 2 months postvaccination.⁷ Atanasoff and colleagues found that 93% of patients had pain onset within 24 hours of vaccination with 54% reporting immediate pain.⁴

The Vaccine Adverse Event Reporting System (VAERS) tracks reports of shoulder dysfunction following certain vaccinations, but the system is unable to establish causality. According to VAERS reporting, between 2010 and 2016, there were 1006 possible reports of shoulder dysfunction following inactivated influenza vaccination (IIV) compared with an estimated 130 million doses of IIV given each influenza season in the US.⁸

Bodor and Montalvo postulated that vaccine antigen was being over penetrated into the synovial space of the shoulder, as the subdeltoid/subacromial bursa is located a mere 0.8 to 1.6 cm below the skin surface in patients with healthy body mass index.² Atanasoff and colleagues expounded that antibodies from previous vaccination or natural infection may then form antigen-antibody complexes, creating prolonged local immune and inflammatory responses leading to bursitis or tendonitis.⁴ Martín Arias and colleagues hypothesized that improper injection technique, including wrong insertion angle, incorrect needle type/size, and failure to account for the patient’s physical characteristics were the most likely causes of SIRVA.⁷

Proper vaccine administration ensures that vaccinations are delivered in a safe and efficacious manner. Safe vaccination practices include the use of trained personnel who receive comprehensive, competency-based training regarding vaccine administration.¹ Aspiration prior to an injection is a practice that has not been evaluated fully. Given that the 2 routinely recommended locations for IM vaccines (deltoid muscle in adults or vastus lateralis muscle in infants) lack large blood vessels, the practice of aspiration prior to an IM vaccine is not currently deemed necessary.¹ Additional safe vaccine practices include the selection of appropriate needle length for muscle penetration and that anatomic landmarks determine the location of vaccination.¹ Despite this, in a survey of 100 medical professionals, half could not name any structure at risk from improper deltoid vaccination technique.⁹

Cook and colleagues used anthropomorphic data to evaluate the potential for injury to the subdeltoid/subacromial bursa and/or the axillary nerve.¹⁰ Based on these data, they recommended safe IM vaccine administration can be assured by using the midpoint of the deltoid muscle located midway between the acromion and deltoid tuberosity with the arm abducted to 60°.^10,11 In 46% of SIRVA cases described by Atanasoff and colleagues, patients reported that the vaccine was administered “too high.”⁴ The study also recommended that the clinician and the patient be in the seated position to ensure proper needle angle and location of administration.⁴ For most adults, a 1-inch needle is appropriate for vaccine administration in the deltoid; however, in females weighing < 70 kg and males < 75 kg, a 5/8-inch needle is recommended to avoid injury.⁷

Our 91-kg patient was appropriately administered his vaccine with a 1-inch needle. As he experienced immediate pain, it is unlikely that his symptoms were due to an immune-mediated process, as this would not be expected to occur immediately. Improper location of vaccine administration is a proposed mechanism of injury for our patient, though this cannot be confirmed by history alone. His prior history of traumatic injury to the opposite shoulder could represent a confounding factor as no prior imaging was available for the vaccine-affected shoulder. A preexisting shoulder abnormality or injury cannot be completely excluded, and it is possible that an underlying prior shoulder injury was aggravated postvaccination.

Evaluation and Treatment

There is no standardized approach for the evaluation of SIRVA to date. Awareness of SIRVA and a high index of suspicion are necessary to evaluate patients with shoulder concerns postvaccination. Laboratory evaluation should be considered to evaluate for other potential diagnoses (eg, infection, rheumatologic concerns). Routine X-rays are not helpful in cases of SIRVA. Ultrasound may be considered as it can show bursa abnormalities consistent with bursitis.² MRI of the affected shoulder may provide improved diagnostic capability if SIRVA is suspected. MRI findings vary but include intraosseous edema, bursitis, tendonitis, and rotator cuff tears.^4,12 Complete rotator cuff tears were found in 15% of cases reviewed by Atanasoff and colleagues.⁴ While there is no recommended timing for MRI, 63% of MRIs were performed within 3 months of symptom onset.⁴ As SIRVA is not a neurologic injury, nerve conduction, electromyographic studies, and neurologic evaluation or testing are expected to be normal.

Treatment of SIRVA and other vaccine-related shoulder injuries typically have involved pain management (eg, nonsteroidal anti-inflammatory agents), intra-articular steroid injections, and physical therapy, though some patients never experience complete resolution of symptoms.^2,4,7 Both patients with vaccination-related shoulder dysfunction described by Bodor and colleagues improved after intra-articular triamcinolone injections, with up to 3 injections before complete resolution of pain in one patient.² Orthopedics evaluation may need to be considered for persistent symptoms. According to Atanasoff and colleagues, most patients were symptomatic for at least 6 months, and complete recovery was seen in less than one-third of patients.⁴ Although the development of SIRVA is not a contraindication to future doses of the presumed causative vaccine, subsequent vaccination should include careful consideration of other administration sites if possible (eg, vastus lateralis may be used for IM injections in adults) (Figure 4).

Reporting

A diagnosis or concern for SIRVA also should be reported to the VAERS, the national database established in order to detect possible safety problems with US-licensed vaccines. VAERS reports can be submitted by anyone with concerns for vaccine adverse reactions, including patients, caregivers, and health care professionals at vaers.hhs.gov/reportevent.html. Additional information regarding VICP can be obtained at www.hrsa.gov/vaccine-compensation/index.html.

Military-Specific Issues

The military values readiness, which includes ensuring that active-duty members remain up-to-date on life-saving vaccinations. Immunization is of critical importance to mobility and success of the overall mission. Mobility processing lines where immunizations can be provided to multiple active-duty members can be a successful strategy for mass immunizations. Although the quick administration of immunizations maintains readiness and provides a medically necessary service, it also may increase the chances of incorrect vaccine placement in the deltoid, causing long-term shoulder immobility that may impact a service member’s retainability. The benefits of mobility processing lines can continue to outweigh the risks of immunization administration by ensuring proper staff training, seating both the administrator and recipient of vaccination, and selecting a proper needle length and site of administration specific to each recipient.

Conclusion

Correct administration of vaccines is of utmost importance in preventing SIRVA and other vaccine-related shoulder dysfunctions. Proper staff training and refresher training can help prevent vaccine-related shoulder injuries. Additionally, clinicians should be aware of this potential complication and maintain a high index of suspicion when evaluating patients with postvaccination shoulder complaints.

Localized reactions and transient pain at the site of vaccine administration are frequent and well-described occurrences that are typically short-lived and mild in nature. The most common findings at the injection site are soreness, erythema, and edema.¹ Although less common, generalized shoulder dysfunction after vaccine administration also has been reported. Bodor and colleagues described a peri-articular inflammatory response that led to shoulder pain and weakness.² A single case report by Kuether and colleagues described atraumatic osteonecrosis of the humeral head after H1N1 vaccine administration in the deltoid.³ In 2010, shoulder injury related to vaccine administration (SIRVA) was described by Atanasoff and colleagues as the rapid onset of shoulder pain and dysfunction persisting as a complication of deltoid muscle vaccination in a case series of 13 patients.⁴ In our report, we present a case of an active-duty male eventually diagnosed with SIRVA after influenza vaccination and discuss factors that may prevent vaccine-related shoulder injuries.

Case Presentation

A 31-year-old active-duty male presented to the Allergy clinic for evaluation of persistent left shoulder pain and decreased range of motion (ROM) following influenza vaccination 4 months prior. He reported a history of chronic low back and right shoulder pain. Although the patient had a traumatic injury to his right shoulder, which was corrected with surgery, he had no surgeries on the left shoulder. He reported no prior pain or known trauma to his left shoulder. He had no personal or family history of atopy or vaccine reactions.

The patient weighed 91 kg and received an intramuscular (IM) quadrivalent influenza vaccine with a 25-gauge, 1-inch needle during a mass influenza immunization. He recalled that the site of vaccination was slightly more than 3 cm below the top of the shoulder in a region correlating to the left deltoid. The vaccine was administered while he was standing with his arm extended, adducted, and internally rotated. The patient experienced intense pain immediately after the vaccination and noted decreased ROM. Initially, he dismissed the pain and decreased ROM as routine but sought medical attention when there was no improvement after 3 weeks.

Six weeks after the onset of symptoms, a magnetic resonance image (MRI) revealed tendinopathy of the left distal subscapularis, infraspinatus, supraspinatus, and teres minor tendon. These findings were suggestive of a small partial thickness tear of the supraspinatus (Figure 1), possible calcific tendinopathy of the distal teres minor (Figure 2), and underlying humeral head edema (Figure 3). The patient was evaluated by Orthopedics and experienced no relief from ibuprofen, celecoxib, and a steroid/lidocaine intra-articular injection. Laboratory studies included an unremarkable complete blood count and erythrocyte sedimentation rate. He was diagnosed with SIRVA and continued in physical therapy with incomplete resolution of symptoms 6 months postvaccination.

Discussion

According to a 2018 report issued by the Centers for Disease Control and Prevention, local reactions following immunizations are seen in up to 80% of administered vaccine doses.¹ While most of these reactions are mild, transient, cutaneous reactions, rarely these also may persist and impact quality of life significantly. SIRVA is one such process that can lead to persistent musculoskeletal dysfunction. SIRVA presents as shoulder pain and limited ROM that occurs after the administration of an injectable vaccine. In 2011, the Institute of Medicine determined that evidence supported a causal relationship between vaccine administration and deltoid bursitis.⁵

In 2017, SIRVA was included in the Vaccine Injury Compensation Program (VICP), a federal program that can provide compensation to individuals injured by certain vaccines.⁶ A diagnosis of SIRVA can be considered in patients who experience pain within 48 hours of vaccination, have no prior history of pain or dysfunction of the affected shoulder prior to vaccine administration, and have symptoms limited to the shoulder in which the vaccine was administered where no other abnormality is present to explain these symptoms (eg, brachial neuritis, other neuropathy). Currently, patients with back pain or musculoskeletal complaints that do not include the shoulder following deltoid vaccination do not meet the reporting criteria for SIRVA in the VICP.⁶

The exact prevalence or incidence of SIRVA is unknown. In a 2017 systematic review of the literature and the Spanish Pharmacovigilance System database, Martín Arias and colleagues found 45 cases of new onset, unilateral shoulder dysfunction without associated neuropathy or autoimmune conditions following vaccine administration. They noted a female to male predominance (71.1% vs 28.9%) with a mean age of 53.6 years (range 22-89 y). Most of the cases occurred following influenza vaccine (62%); pneumococcal vaccine was the next most common (13%).⁷ Shoulder injury also has been reported after tetanus-diphtheria toxoids, human papilloma virus, and hepatitis A virus vaccines.^4,7 The review noted that all patients had onset of pain within the first week following vaccination with the majority (81%) having pain in the first 24 hours. Two cases found in the Spanish database had pain onset 2 months postvaccination.⁷ Atanasoff and colleagues found that 93% of patients had pain onset within 24 hours of vaccination with 54% reporting immediate pain.⁴

The Vaccine Adverse Event Reporting System (VAERS) tracks reports of shoulder dysfunction following certain vaccinations, but the system is unable to establish causality. According to VAERS reporting, between 2010 and 2016, there were 1006 possible reports of shoulder dysfunction following inactivated influenza vaccination (IIV) compared with an estimated 130 million doses of IIV given each influenza season in the US.⁸

Bodor and Montalvo postulated that vaccine antigen was being over penetrated into the synovial space of the shoulder, as the subdeltoid/subacromial bursa is located a mere 0.8 to 1.6 cm below the skin surface in patients with healthy body mass index.² Atanasoff and colleagues expounded that antibodies from previous vaccination or natural infection may then form antigen-antibody complexes, creating prolonged local immune and inflammatory responses leading to bursitis or tendonitis.⁴ Martín Arias and colleagues hypothesized that improper injection technique, including wrong insertion angle, incorrect needle type/size, and failure to account for the patient’s physical characteristics were the most likely causes of SIRVA.⁷

Proper vaccine administration ensures that vaccinations are delivered in a safe and efficacious manner. Safe vaccination practices include the use of trained personnel who receive comprehensive, competency-based training regarding vaccine administration.¹ Aspiration prior to an injection is a practice that has not been evaluated fully. Given that the 2 routinely recommended locations for IM vaccines (deltoid muscle in adults or vastus lateralis muscle in infants) lack large blood vessels, the practice of aspiration prior to an IM vaccine is not currently deemed necessary.¹ Additional safe vaccine practices include the selection of appropriate needle length for muscle penetration and that anatomic landmarks determine the location of vaccination.¹ Despite this, in a survey of 100 medical professionals, half could not name any structure at risk from improper deltoid vaccination technique.⁹

Cook and colleagues used anthropomorphic data to evaluate the potential for injury to the subdeltoid/subacromial bursa and/or the axillary nerve.¹⁰ Based on these data, they recommended safe IM vaccine administration can be assured by using the midpoint of the deltoid muscle located midway between the acromion and deltoid tuberosity with the arm abducted to 60°.^10,11 In 46% of SIRVA cases described by Atanasoff and colleagues, patients reported that the vaccine was administered “too high.”⁴ The study also recommended that the clinician and the patient be in the seated position to ensure proper needle angle and location of administration.⁴ For most adults, a 1-inch needle is appropriate for vaccine administration in the deltoid; however, in females weighing < 70 kg and males < 75 kg, a 5/8-inch needle is recommended to avoid injury.⁷

Our 91-kg patient was appropriately administered his vaccine with a 1-inch needle. As he experienced immediate pain, it is unlikely that his symptoms were due to an immune-mediated process, as this would not be expected to occur immediately. Improper location of vaccine administration is a proposed mechanism of injury for our patient, though this cannot be confirmed by history alone. His prior history of traumatic injury to the opposite shoulder could represent a confounding factor as no prior imaging was available for the vaccine-affected shoulder. A preexisting shoulder abnormality or injury cannot be completely excluded, and it is possible that an underlying prior shoulder injury was aggravated postvaccination.

Evaluation and Treatment

There is no standardized approach for the evaluation of SIRVA to date. Awareness of SIRVA and a high index of suspicion are necessary to evaluate patients with shoulder concerns postvaccination. Laboratory evaluation should be considered to evaluate for other potential diagnoses (eg, infection, rheumatologic concerns). Routine X-rays are not helpful in cases of SIRVA. Ultrasound may be considered as it can show bursa abnormalities consistent with bursitis.² MRI of the affected shoulder may provide improved diagnostic capability if SIRVA is suspected. MRI findings vary but include intraosseous edema, bursitis, tendonitis, and rotator cuff tears.^4,12 Complete rotator cuff tears were found in 15% of cases reviewed by Atanasoff and colleagues.⁴ While there is no recommended timing for MRI, 63% of MRIs were performed within 3 months of symptom onset.⁴ As SIRVA is not a neurologic injury, nerve conduction, electromyographic studies, and neurologic evaluation or testing are expected to be normal.

Treatment of SIRVA and other vaccine-related shoulder injuries typically have involved pain management (eg, nonsteroidal anti-inflammatory agents), intra-articular steroid injections, and physical therapy, though some patients never experience complete resolution of symptoms.^2,4,7 Both patients with vaccination-related shoulder dysfunction described by Bodor and colleagues improved after intra-articular triamcinolone injections, with up to 3 injections before complete resolution of pain in one patient.² Orthopedics evaluation may need to be considered for persistent symptoms. According to Atanasoff and colleagues, most patients were symptomatic for at least 6 months, and complete recovery was seen in less than one-third of patients.⁴ Although the development of SIRVA is not a contraindication to future doses of the presumed causative vaccine, subsequent vaccination should include careful consideration of other administration sites if possible (eg, vastus lateralis may be used for IM injections in adults) (Figure 4).

Reporting

A diagnosis or concern for SIRVA also should be reported to the VAERS, the national database established in order to detect possible safety problems with US-licensed vaccines. VAERS reports can be submitted by anyone with concerns for vaccine adverse reactions, including patients, caregivers, and health care professionals at vaers.hhs.gov/reportevent.html. Additional information regarding VICP can be obtained at www.hrsa.gov/vaccine-compensation/index.html.

Military-Specific Issues

The military values readiness, which includes ensuring that active-duty members remain up-to-date on life-saving vaccinations. Immunization is of critical importance to mobility and success of the overall mission. Mobility processing lines where immunizations can be provided to multiple active-duty members can be a successful strategy for mass immunizations. Although the quick administration of immunizations maintains readiness and provides a medically necessary service, it also may increase the chances of incorrect vaccine placement in the deltoid, causing long-term shoulder immobility that may impact a service member’s retainability. The benefits of mobility processing lines can continue to outweigh the risks of immunization administration by ensuring proper staff training, seating both the administrator and recipient of vaccination, and selecting a proper needle length and site of administration specific to each recipient.

Conclusion

Correct administration of vaccines is of utmost importance in preventing SIRVA and other vaccine-related shoulder dysfunctions. Proper staff training and refresher training can help prevent vaccine-related shoulder injuries. Additionally, clinicians should be aware of this potential complication and maintain a high index of suspicion when evaluating patients with postvaccination shoulder complaints.

Nonadherence is a significant problem that has a negative impact on both patients and public health. Patients with multiple diseases often have complicated medication regimens, which can be difficult for them to manage. Unfortunately, nonadherence in these high-risk patients can have drastic consequences, including disease progression, hospitalization, and death, resulting in billions of dollars in unnecessary costs nationwide.^1,2 The Wheel Model of Pharmaceutical Care (Figure) is a novel care model developed at the Gallup Indian Medical Center (GIMC) in New Mexico to address these problems by positioning pharmacy as a proactive service. The Wheel Model of Pharmaceutical Care was designed to improve adherence and patient outcomes and to encourage communication among the patient, pharmacists, prescribers, and other health care team members.

Pharmacists are central to managing patients’ medication therapies and coordinating communication among the health care providers (HCPs).^1,3 Medication therapy management (MTM), a required component of Medicare Part D plans, helps ensure appropriate drug use and reduce the risk of adverse events.³ Since pharmacists receive prescriptions from all of the patient’s HCPs, patients may see pharmacists more often than they see any other HCP. GIMC is currently piloting a new clinic, the Medication Optimization, Synchronization, and Adherence Improvement Clinic (MOSAIC), that was created to implement the Wheel Model of Pharmaceutical Care. MOSAIC aims to provide proactive pharmacy services and continuous MTM to high-risk patients and will enable the effectiveness of this new pharmaceutical care model to be assessed.

Methods

Studies have identified certain populations who are at an increased risk for nonadherence: the elderly, patients with complex or extensive medication regimens, patients with multiple chronic medical conditions, substance misusers, certain ethnicities, patients of lower socioeconomic status, patients with limited literacy, and the homeless.^2,4 Federal regulations require that Medicare Part D plans target beneficiaries who meet specific criteria for MTM programs. Under these rules, plans must target beneficiaries with ≥ 3 chronic diseases and ≥ 8 chronic medications, although plans also may include patients with fewer medications and diseases.³ Although the Wheel Model of Pharmaceutical Care is postulated to be an accurate model for the ideal care of all patients, initial implementation should be targeted toward populations who are likely to benefit the most from intervention. For these reasons, elderly Native American patients who have ≥ 2 chronic diseases and who take ≥ 5 chronic medications were targeted for initial enrollment in MOSAIC at GIMC.

Overview

In MOSAIC, pharmacists act as the hub of the pharmaceutical care wheel. Pharmacists work to ensure optimization of the patient’s comprehensive, integrated care plan—the rim of the wheel. As a part of this optimization process, MOSAIC pharmacists facilitate synchronization of the patient’s prescriptions to a monthly or quarterly target fill date. The patient’s current medication therapy is organized, and pharmacists track which medications are due to be filled instead of depending on the patient to request each prescription refill. This process effectively changes pharmacy from a requested service to a provided service.

Pharmacists also monitor the air in the tire to promote adherence. This is accomplished by providing efficient monthly or quarterly telephone or in-person consultations, which helps the patient better understand his or her comprehensive, integrated care plan. MOSAIC eliminates the possibility of nonadherence due to running out of refills. Specialized packaging, such as pill boxes or blister packs, can also improve adherence for certain patients.

MOSAIC ensures that pharmacists stay connected with the spokes, which represent a patient’s numerous prescribers, and close communication loops. Pharmacists can make prescribers aware of potential gaps or overlaps in treatment and assist them in the optimization and development of the patient’s comprehensive, integrated care plan. Pharmacists also make sure that the patient’s medication profile is current and accurate in the electronic health record (EHR). Any pertinent information discovered during MOSAIC encounters, such as abnormal laboratory results or changes in medications or disease, is documented in an EHR note. The patient’s prescribers are made aware of this information by tagging them as additional signers to the note in the EHR.

Keeping patients—the tires—healthy will ensure smooth operation of the vehicle and have a positive impact on public health. MOSAIC is expected to not only improve individual patient outcomes, but also decrease health care costs for patients and society due to nonadherence, suboptimal regimens, stockpiled home medications, and preventable hospital admissions.

Traditionally, pharmacy has been a requested service: A patient requests each of their prescriptions to be refilled, and the pharmacy fills the prescription. Ideally, pharmacy must become a provided service, with pharmacists keeping track of when a patient’s medications are due to be filled and actively looking for medication therapy optimization opportunities. This is accomplished by synchronizing the patient’s medications to the same monthly or quarterly fill date; screening for any potentially inappropriate medications, including high-risk medications in elderly patients, duplications, and omissions; verifying any medication changes with the patient each fill; and then providing all needed medications to the patient at a scheduled time.

To facilitate this process, custom software was developed for MOSAIC. In addition, a collaborative practice agreement (CPA) was drafted that allowed MOSAIC pharmacists to make certain medication therapy optimizations on behalf of the patient’s primary care provider. As part of this CPA, pharmacists also may order and act on certain laboratory tests, which helps to monitor disease progression, ensure safe medication use, and meet Government Performance and Results Act (GPRA) measures. As a novel model of pharmaceutical care, the effects of this approach are not yet known; however, research suggests that increased communication among HCPs and patient-centered approaches to care are beneficial to patient outcomes, adherence, and public health.^1,5

Investigated Outcomes

As patients continue to enroll in MOSAIC, the effectiveness of the clinic will be evaluated. Specifically, quality of life, patient and HCP satisfaction with the program, adherence metrics, hospitalization rates, and all-cause mortality will be assessed for patients enrolled in MOSAIC as well as similar patients who are not enrolled in MOSAIC. Also, pharmacists will log all recommended medication therapy interventions so that the optimization component of MOSAIC may be quantified. GPRA measures and the financial implications of the interventions made by MOSAIC will also be evaluated.

Discussion

There are a number of factors, such as MTM services and interprofessional care teams, that research has shown to independently improve patient outcomes, adherence, or public health. By synthesizing these factors, a completely new approach—the Wheel Model of Pharmaceutical Care—was developed. This model presents a radical departure from traditional, requested-service practices and posits pharmacy as a provided service instead. Although the ideas of MTM and interprofessional care teams are not new, there has never been a practical way to truly integrate community pharmacists into the patient care team or to ensure adequate communication among all of the patient’s HCPs. The Wheel Model of Pharmaceutical Care includes public health as one of its core components and provides a framework for pharmacies to meaningfully impact health outcomes for patients.

The Wheel Model of Pharmaceutical Care was designed to minimize the likelihood of nonadherence. Despite this, patients might willfully choose to be nonadherent, forget to take their medications, or neglect to pick up their medications. Additionally, in health care systems where patients must pay for their medications, prescription drug costs might be a barrier to adherence.

When nonadherence is suspected, the Wheel Model of Pharmaceutical Care directs pharmacists in MOSAIC to take action. First, the underlying cause of the nonadherence must be determined. For example, if a patient is nonadherent because of an adverse drug reaction, a therapy change may be indicated. If a patient is nonadherent due to apathy toward their health or therapy, the patient may benefit from education about their condition and treatment options; thus, the patient can make shared, informed decisions and feel more actively involved with his or her health. If a patients is nonadherent due to forgetfulness, adherence packaging dispense methods should be considered as an alternative to traditional vials. Depending on the services offered by a given pharmacy, adherence packaging options may include blister packs, pill boxes, or strips prepared by robotic dispensing systems. The use of medication reminders, whether in the form of a smartphone application or a simple alarm clock, should be discussed with the patient. If the patient does not pick up their medications on time, a pharmacist can contact the patient to determine why the medications were not picked up and to assess any nonadherence. In this case, mail order pharmacy services, if available, should be offered to patients as a more convenient option.

The medication regimen optimization component of MOSAIC helps reduce the workload of primary care providers and allows pharmacists to act autonomously based on clinical judgment, within the scope of the CPA. This can prevent delays in care caused by no refills remaining on a prescription. The laboratory monitoring component allows pharmacists to track diseases and take action if necessary, which should have a favorable impact on GPRA measures. Medication optimizations can reduce wasted resources by identifying cost-saving formulary alternatives, potentially inappropriate medications, and suboptimal doses.

Since many Indian Health Service beneficiaries do not have private insurance and therefore do not generate third-party reimbursements for services and care provided by GIMC, keeping patients healthy and out of the hospital is a top priority. As more patients are enrolled in MOSAIC, the program is expected to have a favorable impact on pharmacy workload and workflow as well. Prescriptions are anticipated and filled in advance, which decreases the amount of patients calling and presenting to the pharmacy for same-day refill requests. Scheduling when MOSAIC patients’ medications are to be filled and dispensed creates a predictable workload that allows the pharmacy staff to be managed more efficiently.

Conclusion

Adherence is the responsibility of the patient, but the Wheel Model of Pharmaceutical Care aims to provide pharmacists with a framework to monitor and encourage adherence in their patients. By taking this patient-centered approach, MOSAIC is expected to improve outcomes and decrease hospitalizations for high-risk patients who simply need a little extra help with their medications.

Nonadherence is a significant problem that has a negative impact on both patients and public health. Patients with multiple diseases often have complicated medication regimens, which can be difficult for them to manage. Unfortunately, nonadherence in these high-risk patients can have drastic consequences, including disease progression, hospitalization, and death, resulting in billions of dollars in unnecessary costs nationwide.^1,2 The Wheel Model of Pharmaceutical Care (Figure) is a novel care model developed at the Gallup Indian Medical Center (GIMC) in New Mexico to address these problems by positioning pharmacy as a proactive service. The Wheel Model of Pharmaceutical Care was designed to improve adherence and patient outcomes and to encourage communication among the patient, pharmacists, prescribers, and other health care team members.

Pharmacists are central to managing patients’ medication therapies and coordinating communication among the health care providers (HCPs).^1,3 Medication therapy management (MTM), a required component of Medicare Part D plans, helps ensure appropriate drug use and reduce the risk of adverse events.³ Since pharmacists receive prescriptions from all of the patient’s HCPs, patients may see pharmacists more often than they see any other HCP. GIMC is currently piloting a new clinic, the Medication Optimization, Synchronization, and Adherence Improvement Clinic (MOSAIC), that was created to implement the Wheel Model of Pharmaceutical Care. MOSAIC aims to provide proactive pharmacy services and continuous MTM to high-risk patients and will enable the effectiveness of this new pharmaceutical care model to be assessed.

Methods

Studies have identified certain populations who are at an increased risk for nonadherence: the elderly, patients with complex or extensive medication regimens, patients with multiple chronic medical conditions, substance misusers, certain ethnicities, patients of lower socioeconomic status, patients with limited literacy, and the homeless.^2,4 Federal regulations require that Medicare Part D plans target beneficiaries who meet specific criteria for MTM programs. Under these rules, plans must target beneficiaries with ≥ 3 chronic diseases and ≥ 8 chronic medications, although plans also may include patients with fewer medications and diseases.³ Although the Wheel Model of Pharmaceutical Care is postulated to be an accurate model for the ideal care of all patients, initial implementation should be targeted toward populations who are likely to benefit the most from intervention. For these reasons, elderly Native American patients who have ≥ 2 chronic diseases and who take ≥ 5 chronic medications were targeted for initial enrollment in MOSAIC at GIMC.

Overview

In MOSAIC, pharmacists act as the hub of the pharmaceutical care wheel. Pharmacists work to ensure optimization of the patient’s comprehensive, integrated care plan—the rim of the wheel. As a part of this optimization process, MOSAIC pharmacists facilitate synchronization of the patient’s prescriptions to a monthly or quarterly target fill date. The patient’s current medication therapy is organized, and pharmacists track which medications are due to be filled instead of depending on the patient to request each prescription refill. This process effectively changes pharmacy from a requested service to a provided service.

Pharmacists also monitor the air in the tire to promote adherence. This is accomplished by providing efficient monthly or quarterly telephone or in-person consultations, which helps the patient better understand his or her comprehensive, integrated care plan. MOSAIC eliminates the possibility of nonadherence due to running out of refills. Specialized packaging, such as pill boxes or blister packs, can also improve adherence for certain patients.

MOSAIC ensures that pharmacists stay connected with the spokes, which represent a patient’s numerous prescribers, and close communication loops. Pharmacists can make prescribers aware of potential gaps or overlaps in treatment and assist them in the optimization and development of the patient’s comprehensive, integrated care plan. Pharmacists also make sure that the patient’s medication profile is current and accurate in the electronic health record (EHR). Any pertinent information discovered during MOSAIC encounters, such as abnormal laboratory results or changes in medications or disease, is documented in an EHR note. The patient’s prescribers are made aware of this information by tagging them as additional signers to the note in the EHR.

Keeping patients—the tires—healthy will ensure smooth operation of the vehicle and have a positive impact on public health. MOSAIC is expected to not only improve individual patient outcomes, but also decrease health care costs for patients and society due to nonadherence, suboptimal regimens, stockpiled home medications, and preventable hospital admissions.

Traditionally, pharmacy has been a requested service: A patient requests each of their prescriptions to be refilled, and the pharmacy fills the prescription. Ideally, pharmacy must become a provided service, with pharmacists keeping track of when a patient’s medications are due to be filled and actively looking for medication therapy optimization opportunities. This is accomplished by synchronizing the patient’s medications to the same monthly or quarterly fill date; screening for any potentially inappropriate medications, including high-risk medications in elderly patients, duplications, and omissions; verifying any medication changes with the patient each fill; and then providing all needed medications to the patient at a scheduled time.

To facilitate this process, custom software was developed for MOSAIC. In addition, a collaborative practice agreement (CPA) was drafted that allowed MOSAIC pharmacists to make certain medication therapy optimizations on behalf of the patient’s primary care provider. As part of this CPA, pharmacists also may order and act on certain laboratory tests, which helps to monitor disease progression, ensure safe medication use, and meet Government Performance and Results Act (GPRA) measures. As a novel model of pharmaceutical care, the effects of this approach are not yet known; however, research suggests that increased communication among HCPs and patient-centered approaches to care are beneficial to patient outcomes, adherence, and public health.^1,5

Investigated Outcomes

As patients continue to enroll in MOSAIC, the effectiveness of the clinic will be evaluated. Specifically, quality of life, patient and HCP satisfaction with the program, adherence metrics, hospitalization rates, and all-cause mortality will be assessed for patients enrolled in MOSAIC as well as similar patients who are not enrolled in MOSAIC. Also, pharmacists will log all recommended medication therapy interventions so that the optimization component of MOSAIC may be quantified. GPRA measures and the financial implications of the interventions made by MOSAIC will also be evaluated.

Discussion

There are a number of factors, such as MTM services and interprofessional care teams, that research has shown to independently improve patient outcomes, adherence, or public health. By synthesizing these factors, a completely new approach—the Wheel Model of Pharmaceutical Care—was developed. This model presents a radical departure from traditional, requested-service practices and posits pharmacy as a provided service instead. Although the ideas of MTM and interprofessional care teams are not new, there has never been a practical way to truly integrate community pharmacists into the patient care team or to ensure adequate communication among all of the patient’s HCPs. The Wheel Model of Pharmaceutical Care includes public health as one of its core components and provides a framework for pharmacies to meaningfully impact health outcomes for patients.

The Wheel Model of Pharmaceutical Care was designed to minimize the likelihood of nonadherence. Despite this, patients might willfully choose to be nonadherent, forget to take their medications, or neglect to pick up their medications. Additionally, in health care systems where patients must pay for their medications, prescription drug costs might be a barrier to adherence.

When nonadherence is suspected, the Wheel Model of Pharmaceutical Care directs pharmacists in MOSAIC to take action. First, the underlying cause of the nonadherence must be determined. For example, if a patient is nonadherent because of an adverse drug reaction, a therapy change may be indicated. If a patient is nonadherent due to apathy toward their health or therapy, the patient may benefit from education about their condition and treatment options; thus, the patient can make shared, informed decisions and feel more actively involved with his or her health. If a patients is nonadherent due to forgetfulness, adherence packaging dispense methods should be considered as an alternative to traditional vials. Depending on the services offered by a given pharmacy, adherence packaging options may include blister packs, pill boxes, or strips prepared by robotic dispensing systems. The use of medication reminders, whether in the form of a smartphone application or a simple alarm clock, should be discussed with the patient. If the patient does not pick up their medications on time, a pharmacist can contact the patient to determine why the medications were not picked up and to assess any nonadherence. In this case, mail order pharmacy services, if available, should be offered to patients as a more convenient option.

The medication regimen optimization component of MOSAIC helps reduce the workload of primary care providers and allows pharmacists to act autonomously based on clinical judgment, within the scope of the CPA. This can prevent delays in care caused by no refills remaining on a prescription. The laboratory monitoring component allows pharmacists to track diseases and take action if necessary, which should have a favorable impact on GPRA measures. Medication optimizations can reduce wasted resources by identifying cost-saving formulary alternatives, potentially inappropriate medications, and suboptimal doses.

Since many Indian Health Service beneficiaries do not have private insurance and therefore do not generate third-party reimbursements for services and care provided by GIMC, keeping patients healthy and out of the hospital is a top priority. As more patients are enrolled in MOSAIC, the program is expected to have a favorable impact on pharmacy workload and workflow as well. Prescriptions are anticipated and filled in advance, which decreases the amount of patients calling and presenting to the pharmacy for same-day refill requests. Scheduling when MOSAIC patients’ medications are to be filled and dispensed creates a predictable workload that allows the pharmacy staff to be managed more efficiently.

Conclusion

Adherence is the responsibility of the patient, but the Wheel Model of Pharmaceutical Care aims to provide pharmacists with a framework to monitor and encourage adherence in their patients. By taking this patient-centered approach, MOSAIC is expected to improve outcomes and decrease hospitalizations for high-risk patients who simply need a little extra help with their medications.

Nonadherence is a significant problem that has a negative impact on both patients and public health. Patients with multiple diseases often have complicated medication regimens, which can be difficult for them to manage. Unfortunately, nonadherence in these high-risk patients can have drastic consequences, including disease progression, hospitalization, and death, resulting in billions of dollars in unnecessary costs nationwide.^1,2 The Wheel Model of Pharmaceutical Care (Figure) is a novel care model developed at the Gallup Indian Medical Center (GIMC) in New Mexico to address these problems by positioning pharmacy as a proactive service. The Wheel Model of Pharmaceutical Care was designed to improve adherence and patient outcomes and to encourage communication among the patient, pharmacists, prescribers, and other health care team members.

Pharmacists are central to managing patients’ medication therapies and coordinating communication among the health care providers (HCPs).^1,3 Medication therapy management (MTM), a required component of Medicare Part D plans, helps ensure appropriate drug use and reduce the risk of adverse events.³ Since pharmacists receive prescriptions from all of the patient’s HCPs, patients may see pharmacists more often than they see any other HCP. GIMC is currently piloting a new clinic, the Medication Optimization, Synchronization, and Adherence Improvement Clinic (MOSAIC), that was created to implement the Wheel Model of Pharmaceutical Care. MOSAIC aims to provide proactive pharmacy services and continuous MTM to high-risk patients and will enable the effectiveness of this new pharmaceutical care model to be assessed.

Methods

Studies have identified certain populations who are at an increased risk for nonadherence: the elderly, patients with complex or extensive medication regimens, patients with multiple chronic medical conditions, substance misusers, certain ethnicities, patients of lower socioeconomic status, patients with limited literacy, and the homeless.^2,4 Federal regulations require that Medicare Part D plans target beneficiaries who meet specific criteria for MTM programs. Under these rules, plans must target beneficiaries with ≥ 3 chronic diseases and ≥ 8 chronic medications, although plans also may include patients with fewer medications and diseases.³ Although the Wheel Model of Pharmaceutical Care is postulated to be an accurate model for the ideal care of all patients, initial implementation should be targeted toward populations who are likely to benefit the most from intervention. For these reasons, elderly Native American patients who have ≥ 2 chronic diseases and who take ≥ 5 chronic medications were targeted for initial enrollment in MOSAIC at GIMC.

Overview

In MOSAIC, pharmacists act as the hub of the pharmaceutical care wheel. Pharmacists work to ensure optimization of the patient’s comprehensive, integrated care plan—the rim of the wheel. As a part of this optimization process, MOSAIC pharmacists facilitate synchronization of the patient’s prescriptions to a monthly or quarterly target fill date. The patient’s current medication therapy is organized, and pharmacists track which medications are due to be filled instead of depending on the patient to request each prescription refill. This process effectively changes pharmacy from a requested service to a provided service.

Pharmacists also monitor the air in the tire to promote adherence. This is accomplished by providing efficient monthly or quarterly telephone or in-person consultations, which helps the patient better understand his or her comprehensive, integrated care plan. MOSAIC eliminates the possibility of nonadherence due to running out of refills. Specialized packaging, such as pill boxes or blister packs, can also improve adherence for certain patients.

MOSAIC ensures that pharmacists stay connected with the spokes, which represent a patient’s numerous prescribers, and close communication loops. Pharmacists can make prescribers aware of potential gaps or overlaps in treatment and assist them in the optimization and development of the patient’s comprehensive, integrated care plan. Pharmacists also make sure that the patient’s medication profile is current and accurate in the electronic health record (EHR). Any pertinent information discovered during MOSAIC encounters, such as abnormal laboratory results or changes in medications or disease, is documented in an EHR note. The patient’s prescribers are made aware of this information by tagging them as additional signers to the note in the EHR.

Keeping patients—the tires—healthy will ensure smooth operation of the vehicle and have a positive impact on public health. MOSAIC is expected to not only improve individual patient outcomes, but also decrease health care costs for patients and society due to nonadherence, suboptimal regimens, stockpiled home medications, and preventable hospital admissions.

Traditionally, pharmacy has been a requested service: A patient requests each of their prescriptions to be refilled, and the pharmacy fills the prescription. Ideally, pharmacy must become a provided service, with pharmacists keeping track of when a patient’s medications are due to be filled and actively looking for medication therapy optimization opportunities. This is accomplished by synchronizing the patient’s medications to the same monthly or quarterly fill date; screening for any potentially inappropriate medications, including high-risk medications in elderly patients, duplications, and omissions; verifying any medication changes with the patient each fill; and then providing all needed medications to the patient at a scheduled time.

To facilitate this process, custom software was developed for MOSAIC. In addition, a collaborative practice agreement (CPA) was drafted that allowed MOSAIC pharmacists to make certain medication therapy optimizations on behalf of the patient’s primary care provider. As part of this CPA, pharmacists also may order and act on certain laboratory tests, which helps to monitor disease progression, ensure safe medication use, and meet Government Performance and Results Act (GPRA) measures. As a novel model of pharmaceutical care, the effects of this approach are not yet known; however, research suggests that increased communication among HCPs and patient-centered approaches to care are beneficial to patient outcomes, adherence, and public health.^1,5

Investigated Outcomes

As patients continue to enroll in MOSAIC, the effectiveness of the clinic will be evaluated. Specifically, quality of life, patient and HCP satisfaction with the program, adherence metrics, hospitalization rates, and all-cause mortality will be assessed for patients enrolled in MOSAIC as well as similar patients who are not enrolled in MOSAIC. Also, pharmacists will log all recommended medication therapy interventions so that the optimization component of MOSAIC may be quantified. GPRA measures and the financial implications of the interventions made by MOSAIC will also be evaluated.

Discussion

There are a number of factors, such as MTM services and interprofessional care teams, that research has shown to independently improve patient outcomes, adherence, or public health. By synthesizing these factors, a completely new approach—the Wheel Model of Pharmaceutical Care—was developed. This model presents a radical departure from traditional, requested-service practices and posits pharmacy as a provided service instead. Although the ideas of MTM and interprofessional care teams are not new, there has never been a practical way to truly integrate community pharmacists into the patient care team or to ensure adequate communication among all of the patient’s HCPs. The Wheel Model of Pharmaceutical Care includes public health as one of its core components and provides a framework for pharmacies to meaningfully impact health outcomes for patients.

The Wheel Model of Pharmaceutical Care was designed to minimize the likelihood of nonadherence. Despite this, patients might willfully choose to be nonadherent, forget to take their medications, or neglect to pick up their medications. Additionally, in health care systems where patients must pay for their medications, prescription drug costs might be a barrier to adherence.

When nonadherence is suspected, the Wheel Model of Pharmaceutical Care directs pharmacists in MOSAIC to take action. First, the underlying cause of the nonadherence must be determined. For example, if a patient is nonadherent because of an adverse drug reaction, a therapy change may be indicated. If a patient is nonadherent due to apathy toward their health or therapy, the patient may benefit from education about their condition and treatment options; thus, the patient can make shared, informed decisions and feel more actively involved with his or her health. If a patients is nonadherent due to forgetfulness, adherence packaging dispense methods should be considered as an alternative to traditional vials. Depending on the services offered by a given pharmacy, adherence packaging options may include blister packs, pill boxes, or strips prepared by robotic dispensing systems. The use of medication reminders, whether in the form of a smartphone application or a simple alarm clock, should be discussed with the patient. If the patient does not pick up their medications on time, a pharmacist can contact the patient to determine why the medications were not picked up and to assess any nonadherence. In this case, mail order pharmacy services, if available, should be offered to patients as a more convenient option.

The medication regimen optimization component of MOSAIC helps reduce the workload of primary care providers and allows pharmacists to act autonomously based on clinical judgment, within the scope of the CPA. This can prevent delays in care caused by no refills remaining on a prescription. The laboratory monitoring component allows pharmacists to track diseases and take action if necessary, which should have a favorable impact on GPRA measures. Medication optimizations can reduce wasted resources by identifying cost-saving formulary alternatives, potentially inappropriate medications, and suboptimal doses.

Since many Indian Health Service beneficiaries do not have private insurance and therefore do not generate third-party reimbursements for services and care provided by GIMC, keeping patients healthy and out of the hospital is a top priority. As more patients are enrolled in MOSAIC, the program is expected to have a favorable impact on pharmacy workload and workflow as well. Prescriptions are anticipated and filled in advance, which decreases the amount of patients calling and presenting to the pharmacy for same-day refill requests. Scheduling when MOSAIC patients’ medications are to be filled and dispensed creates a predictable workload that allows the pharmacy staff to be managed more efficiently.

Conclusion

Adherence is the responsibility of the patient, but the Wheel Model of Pharmaceutical Care aims to provide pharmacists with a framework to monitor and encourage adherence in their patients. By taking this patient-centered approach, MOSAIC is expected to improve outcomes and decrease hospitalizations for high-risk patients who simply need a little extra help with their medications.

Patients experiencing sacroiliac joint (SIJ) dysfunction might show symptoms that overlap with those seen in lumbar spine pathology. This article reviews diagnostic tools that assist practitioners to discern the true pain generator in patients with low back pain (LBP) and therapeutic approaches when the cause is SIJ dysfunction.

Prevalence

Most of the US population will experience LBP at some point in their lives. A 2002 National Health Interview survey found that more than one-quarter (26.4%) of 31 044 respondents had complained of LBP in the previous 3 months.¹ About 74 million individuals in the US experienced LBP in the past 3 months.¹ A full 10% of the US population is expected to suffer from chronic LBP, and it is estimated that 2.3% of all visits to physicians are related to LBP.¹

The etiology of LBP often is unclear even after thorough clinical and radiographic evaluation because of the myriad possible mechanisms. Degenerative disc disease, facet arthropathy, ligamentous hypertrophy, muscle spasm, hip arthropathy, and SIJ dysfunction are potential pain generators and exact clinical and radiographic correlation is not always possible. Compounding this difficulty is the lack of specificity with current diagnostic techniques. For example, many patients will have disc desiccation or herniation without any LBP or radicular symptoms on radiographic studies, such as X-rays, computed tomography (CT), and magnetic resonance imaging (MRI). As such, providers of patients with diffuse radiographic abnormalities often have to identify a specific pain generator, which might not have any role in the patient’s pain.

Other tests, such as electromyographic studies, positron emission tomography (PET) scans, discography, and epidural steroid injections, can help pinpoint a specific pain generator. These tests might help determine whether the patient has a surgically treatable condition and could help predict whether a patient’s symptoms will respond to surgery.

However, the standard spine surgery workup often fails to identify an obvious pain generator in many individuals. The significant number of patients that fall into this category has prompted spine surgeons to consider other potential etiologies for LBP, and SIJ dysfunction has become a rapidly developing field of research.

Sacroiliac Joint Dysfunction

The SIJ is a bilateral, C-shaped synovial joint surrounded by a fibrous capsule and affixes the sacrum to the ilia. Several sacral ligaments and pelvic muscles support the SIJ. The L5 nerve ventral ramus and lumbosacral trunk pass anteriorly and the S1 nerve ventral ramus passes inferiorly to the joint capsule. The SIJ is innervated by the dorsal rami of L4-S3 nerve roots, transmitting nociception and temperature. Mechanisms of injury to the SIJ could arise from intra- and extra-articular etiologies, including capsular disruption, ligamentous tension, muscular inflammation, shearing, fractures, arthritis, and infection.² Patients could develop SIJ pain spontaneously or after a traumatic event or repetitive shear.³ Risk factors for developing SIJ dysfunction include a history of lumbar fusion, scoliosis, leg length discrepancies, sustained athletic activity, pregnancy, seronegative HLA-B27 spondyloarthropathies, or gait abnormalities. Inflammation of the SIJ and surrounding structures secondary to an environmental insult in susceptible individuals is a common theme among these etiologies.²

Pain from the SIJ is localized to an area of approximately 3 cm × 10 cm that is inferior to the ipsilateral posterior superior iliac spine.⁴ Referred pain maps from SIJ dysfunction extend in the L5-S1 nerve distributions, commonly seen in the buttocks, groin, posterior thigh, and lower leg with radicular symptoms. However, this pain distribution demonstrates extensive variability among patients and bears strong similarities to discogenic or facet joint sources of LBP.^5-7 Direct communication has been shown between the SIJ and adjacent neural structures, namely the L5 nerve, sacral foramina, and the lumbosacral plexus. These direct pathways could explain an inflammatory mechanism for lower extremity symptoms seen in SIJ dysfunction.⁸

The prevalence of SIJ dysfunction among patients with LBP is estimated to be 15% to 30%, an extraordinary number given the total number of patients presenting with LBP every year.⁹ These patients might represent a significant segment of patients with an unrevealing standard spine evaluation. Despite the large number of patients who experience SIJ dysfunction, there is disagreement about optimal methods for diagnosis and treatment.

Diagnosis

The International Association for the Study of Pain has proposed criteria for evaluating patients who have suspected SIJ dysfunction: Pain must be in the SIJ area, should be reproducible by performing specific provocative maneuvers, and must be relieved by injection of local anesthetic into the SIJ.¹⁰ These criteria provide a sound foundation, but in clinical practice, patients often defy categorization.

The presence of pain in the area inferior to the posterior superior iliac spine and lateral to the gluteal fold with pain referral patterns in the L5-S1 nerve distributions is highly sensitive for identifying patients with SIJ dysfunction. Furthermore, pain arising from the SIJ will not be above the level of the L5 nerve sensory distribution. However, this diagnostic finding alone is not specific and might represent other etiologies known to produce similar pain, such as intervertebral discs and facet joints. Patients with SIJ dysfunction often describe their pain as sciatica-like, recurrent, and triggered with bending or twisting motions. It is worsened with any activity loading the SIJ, such as walking, climbing stairs, standing, or sitting upright. SIJ pain might be accompanied by dyspareunia and changes in bladder function because of the nerves involved.¹¹

The use of provocative maneuvers for testing SIJ dysfunction is controversial because of the high rate of false positives and the inability to distinguish whether the SIJ or an adjacent structure is affected. However, the diagnostic utility of specific stress tests has been studied, and clusters of tests are recommended if a health care provider (HCP) suspects SIJ dysfunction. A diagnostic algorithm should first focus on using the distraction test and the thigh thrust test. Distraction is done by applying vertically oriented pressure to the anterior superior iliac spine while aiming posteriorly, therefore distracting the SIJ. During the thigh thrust test the examiner fixates the patient’s sacrum against the table with the left hand and applies a vertical force through the line of the femur aiming posteriorly, producing a posterior shearing force at the SIJ. Studies show that the thigh thrust test is the most sensitive, and the distraction test is the most specific. If both tests are positive, there is reasonable evidence to suggest SIJ dysfunction as the source of LBP.

If there are not 2 positive results, the addition of the compression test, followed by the sacral thrust test also can point to the diagnosis. The compression test is performed with vertical downward force applied to the iliac crest with the patient lying on each side, compressing the SIJ by transverse pressure across the pelvis. The sacral thrust test is performed with vertical force applied to the midline posterior sacrum at its apex directed anteriorly with the patient lying prone, producing a shearing force at the SIJs. The Gaenslen test uses a torsion force by applying a superior and posterior force to the right knee and posteriorly directed force to the left knee. Omitting the Gaenslen test has not been shown to compromise diagnostic efficacy of the other tests and can be safely excluded.¹²

A HCP can rule out SIJ dysfunction if these provocation tests are negative. However, the diagnostic predictive value of these tests is subject to variability among HCPs, and their reliability is increased when used in clusters.^9,13

Imaging for the SIJ should begin with anterior/posterior, oblique, and lateral view plain X-rays of the pelvis (Figures 1 and 2), which will rule out other pathologies by identifying other sources of LBP, such as spondylolisthesis or hip osteoarthritis. HCPs should obtain lumbar and pelvis CT images to identify inflammatory or degenerative changes within the SIJ. CT images provide the high resolution that is needed to identify pathologies, such as fractures and tumors within the pelvic ring that could cause similar pain. MRI does not reliably depict a dysfunctional ligamentous apparatus within the SIJ; however, it can help identify inflammatory sacroiliitis, such as is seen in the spondyloarthropathies.^11,14 Recent studies show combined single photon emission tomography and CT (SPECT-CT) might be the most promising imaging modality to reveal mechanical failure of load transfer with increased scintigraphic uptake in the posterior and superior SIJ ligamentous attachments. The joint loses its characteristic “dumbbell” shape in affected patients with about 50% higher uptake than unaffected joints. These findings were evident in patients who experienced pelvic trauma or during the peripartum period.^15,16

Fluoroscopy-guided intra-articular injection of a local anesthetic (lidocaine) and/or a corticosteroid (triamcinolone) has the dual functionality of diagnosis and treatment (Figure 3). It often is considered the most reliable method to diagnose SIJ dysfunction and has the benefit of pain relief for up to 1 year. However, intra-articular injections lack diagnostic validity because the solution often extravasates to extracapsular structures. This confounds the source of the pain and makes it difficult to interpret these diagnostic injections. In addition, the injection might not reach the entire SIJ capsule and could result in a false-negative diagnosis.^17,18 Periarticular injections have been shown to result in better pain relief in patients diagnosed with SIJ dysfunction than intra-articular injections. Periarticular injections also are easier to perform and could be a first-step option for these patients.¹⁹

Treatment

Nonoperative management of SIJ dysfunction includes exercise programs, physical therapy, manual manipulation therapy, sacroiliac belts, and periodic articular injections. Efficacy of these methods is variable, and analgesics often do not significantly benefit this type of pain. Another nonoperative approach is radiofrequency ablation (RFA) of the lumbar dorsal rami and lateral sacral branches, which can vary based on the number of rami treated as well as the technique used. About two-thirds of patients report pain relief after RFA.2 When successful, pain is relieved for 6 to 12 months, which is a temporary yet effective option for patients experiencing SIJ dysfunction.^14,20

Fusion Surgery

Cadaver studies show that biomechanical stabilization of the SIJ leads to decreased range of motion in flexion/extension, lateral bending, and axial rotation. This results in a decreased need for periarticular muscular and ligamentous support, therefore facilitating load transfer across the SIJ.^21,22 Patients undergoing minimally invasive surgery report better pain relief compared with those receiving open surgery at 12 months postoperatively.²³ The 2 main SIJ fusion approaches used are the lateral transarticular and the dorsal approaches. In the dorsal approach, the SIJ is distracted and allograft dowels or titanium cages with graft are inserted into the joint space posteriorly through the back. When approaching laterally, hollow screw implants filled with graft or triangular titanium implants are placed across the joint, accessing the SIJ through the iliac bones using imaging guidance. This lateral transiliac approach using porous titanium triangular rods currently is the most studied technique.²⁴

A recent prospective, multicenter trial included 423 patients with SIJ dysfunction who were randomized to receive SIJ fusion with triangular titanium implants vs a control group who received nonoperative management. Patients in the SIJ fusion group showed substantially greater improvement in pain (81.4%) compared with that of the nonoperative group (26.1%) 6 months after surgery. Pain relief in the SIJ fusion group was maintained at > 80% at 1 and 2 year follow-up, while the nonoperative group’s pain relief decreased to < 10% at the follow-ups. Measures of quality of life and disability also improved for the SIJ fusion group compared with that of the nonoperative group. Patients who were crossed over from conservative management to SIJ fusion after 6 months demonstrated improvements that were similar to those in the SIJ fusion group by the end of the study. Only 3% of patients required surgical revision. The strongest predictor of pain relief after surgery was a diagnostic SIJ anesthetic block of 30 to 60 minutes, which resulted in > 75% pain reduction.^21,25 Additional predictors of successful SIJ fusion include nonsmokers, nonopioid users, and older patients who have a longer time course of SIJ pain.²⁶

Another study investigating the outcomes of SIJ fusion, RFA, and conservative management with a 6-year follow-up demonstrated similar results.²⁷ This further confirms the durability of the surgical group’s outcome, which sustained significant improvement compared with RFA and conservative management group in pain relief, daily function, and opioid use.

HCPs should consider SIJ fusion for patients who have at least 6 months of unsuccessful nonoperative management, significant SIJ pain (> 5 in a 10-point scale), ≥ 3 positive provocation tests, and at least 50% pain relief (> 75% preferred) with diagnostic intra-articular anesthetic injection.¹⁴ It is reasonable for primary care providers to refer these patients to a neurosurgeon or orthopedic spine surgeon for possible fusion. Patients with earlier lumbar/lumbosacral spinal fusions and persistent LBP should be evaluated for potential SIJ dysfunction. SIJ dysfunction after lumbosacral fusion could be considered a form of distal pseudarthrosis resulting from increased motion at the joint. One study found its incidence correlated with the number of segments fused in the lumbar spine.²⁸ Another study found that about one-third of patients with persistent LBP after lumbosacral fusion could be attributed to SIJ dysfunction.²⁹

Case Presentation

A 27-year-old female army veteran presented with bilateral buttock pain, which she described as a dull, aching pain across her sacral region, 8 out of 10 in severity. The pain was in a L5-S1 pattern. The pain was bilateral, with the right side worse than the left, and worsened with lateral bending and load transferring. She reported no numbness, tingling, or weakness.

On physical examination, she had full strength in her lower extremities and intact sensation. She reported tenderness to palpation of the sacrum and SIJ. Her gait was normal. The patient had positive thigh thrust and distraction tests. Lumbar spine X-ray, CT, MRI, and electromyographic studies did not show any pathology. She described little or no relief with analgesics or physical therapy. Previous L4-L5 and L5-S1 facet anesthetic injections and transforaminal epidural steroid injections provided minimal pain relief immediately after the procedures. Bilateral SIJ anesthetic injections under fluoroscopic guidance decreased her pain severity from a 7 to 3 out of 10 for 2 to 3 months before returning to her baseline. Radiofrequency ablation of the right SIJ under fluoroscopy provided moderate relief for about 4 months.

After exhausting nonoperative management for SIJ dysfunction without adequate pain control, the patient was referred to neurosurgery for surgical fusion. The patient was deemed an appropriate surgical candidate and underwent a right-sided SIJ fusion (Figures 4 and 5). At her 6-month and 1-year follow-up appointments, she had lasting pain relief, 2 out of 10.

Conclusion

SIJ dysfunction is widely overlooked because of the difficulty in distinguishing it from other similarly presenting syndromes. However, with a detailed history, appropriate physical maneuvers, imaging, and adequate response to intra-articular anesthetic, providers can reach an accurate diagnosis that will inform subsequent treatments. After failure of nonsurgical methods, patients with SIJ dysfunction should be considered for minimally invasive fusion techniques, which have proven to be a safe, effective, and viable treatment option.

Patients experiencing sacroiliac joint (SIJ) dysfunction might show symptoms that overlap with those seen in lumbar spine pathology. This article reviews diagnostic tools that assist practitioners to discern the true pain generator in patients with low back pain (LBP) and therapeutic approaches when the cause is SIJ dysfunction.

Prevalence

Most of the US population will experience LBP at some point in their lives. A 2002 National Health Interview survey found that more than one-quarter (26.4%) of 31 044 respondents had complained of LBP in the previous 3 months.¹ About 74 million individuals in the US experienced LBP in the past 3 months.¹ A full 10% of the US population is expected to suffer from chronic LBP, and it is estimated that 2.3% of all visits to physicians are related to LBP.¹

The etiology of LBP often is unclear even after thorough clinical and radiographic evaluation because of the myriad possible mechanisms. Degenerative disc disease, facet arthropathy, ligamentous hypertrophy, muscle spasm, hip arthropathy, and SIJ dysfunction are potential pain generators and exact clinical and radiographic correlation is not always possible. Compounding this difficulty is the lack of specificity with current diagnostic techniques. For example, many patients will have disc desiccation or herniation without any LBP or radicular symptoms on radiographic studies, such as X-rays, computed tomography (CT), and magnetic resonance imaging (MRI). As such, providers of patients with diffuse radiographic abnormalities often have to identify a specific pain generator, which might not have any role in the patient’s pain.

Other tests, such as electromyographic studies, positron emission tomography (PET) scans, discography, and epidural steroid injections, can help pinpoint a specific pain generator. These tests might help determine whether the patient has a surgically treatable condition and could help predict whether a patient’s symptoms will respond to surgery.

However, the standard spine surgery workup often fails to identify an obvious pain generator in many individuals. The significant number of patients that fall into this category has prompted spine surgeons to consider other potential etiologies for LBP, and SIJ dysfunction has become a rapidly developing field of research.

Sacroiliac Joint Dysfunction

The SIJ is a bilateral, C-shaped synovial joint surrounded by a fibrous capsule and affixes the sacrum to the ilia. Several sacral ligaments and pelvic muscles support the SIJ. The L5 nerve ventral ramus and lumbosacral trunk pass anteriorly and the S1 nerve ventral ramus passes inferiorly to the joint capsule. The SIJ is innervated by the dorsal rami of L4-S3 nerve roots, transmitting nociception and temperature. Mechanisms of injury to the SIJ could arise from intra- and extra-articular etiologies, including capsular disruption, ligamentous tension, muscular inflammation, shearing, fractures, arthritis, and infection.² Patients could develop SIJ pain spontaneously or after a traumatic event or repetitive shear.³ Risk factors for developing SIJ dysfunction include a history of lumbar fusion, scoliosis, leg length discrepancies, sustained athletic activity, pregnancy, seronegative HLA-B27 spondyloarthropathies, or gait abnormalities. Inflammation of the SIJ and surrounding structures secondary to an environmental insult in susceptible individuals is a common theme among these etiologies.²

Pain from the SIJ is localized to an area of approximately 3 cm × 10 cm that is inferior to the ipsilateral posterior superior iliac spine.⁴ Referred pain maps from SIJ dysfunction extend in the L5-S1 nerve distributions, commonly seen in the buttocks, groin, posterior thigh, and lower leg with radicular symptoms. However, this pain distribution demonstrates extensive variability among patients and bears strong similarities to discogenic or facet joint sources of LBP.^5-7 Direct communication has been shown between the SIJ and adjacent neural structures, namely the L5 nerve, sacral foramina, and the lumbosacral plexus. These direct pathways could explain an inflammatory mechanism for lower extremity symptoms seen in SIJ dysfunction.⁸

The prevalence of SIJ dysfunction among patients with LBP is estimated to be 15% to 30%, an extraordinary number given the total number of patients presenting with LBP every year.⁹ These patients might represent a significant segment of patients with an unrevealing standard spine evaluation. Despite the large number of patients who experience SIJ dysfunction, there is disagreement about optimal methods for diagnosis and treatment.

Diagnosis

The International Association for the Study of Pain has proposed criteria for evaluating patients who have suspected SIJ dysfunction: Pain must be in the SIJ area, should be reproducible by performing specific provocative maneuvers, and must be relieved by injection of local anesthetic into the SIJ.¹⁰ These criteria provide a sound foundation, but in clinical practice, patients often defy categorization.

The presence of pain in the area inferior to the posterior superior iliac spine and lateral to the gluteal fold with pain referral patterns in the L5-S1 nerve distributions is highly sensitive for identifying patients with SIJ dysfunction. Furthermore, pain arising from the SIJ will not be above the level of the L5 nerve sensory distribution. However, this diagnostic finding alone is not specific and might represent other etiologies known to produce similar pain, such as intervertebral discs and facet joints. Patients with SIJ dysfunction often describe their pain as sciatica-like, recurrent, and triggered with bending or twisting motions. It is worsened with any activity loading the SIJ, such as walking, climbing stairs, standing, or sitting upright. SIJ pain might be accompanied by dyspareunia and changes in bladder function because of the nerves involved.¹¹

The use of provocative maneuvers for testing SIJ dysfunction is controversial because of the high rate of false positives and the inability to distinguish whether the SIJ or an adjacent structure is affected. However, the diagnostic utility of specific stress tests has been studied, and clusters of tests are recommended if a health care provider (HCP) suspects SIJ dysfunction. A diagnostic algorithm should first focus on using the distraction test and the thigh thrust test. Distraction is done by applying vertically oriented pressure to the anterior superior iliac spine while aiming posteriorly, therefore distracting the SIJ. During the thigh thrust test the examiner fixates the patient’s sacrum against the table with the left hand and applies a vertical force through the line of the femur aiming posteriorly, producing a posterior shearing force at the SIJ. Studies show that the thigh thrust test is the most sensitive, and the distraction test is the most specific. If both tests are positive, there is reasonable evidence to suggest SIJ dysfunction as the source of LBP.

If there are not 2 positive results, the addition of the compression test, followed by the sacral thrust test also can point to the diagnosis. The compression test is performed with vertical downward force applied to the iliac crest with the patient lying on each side, compressing the SIJ by transverse pressure across the pelvis. The sacral thrust test is performed with vertical force applied to the midline posterior sacrum at its apex directed anteriorly with the patient lying prone, producing a shearing force at the SIJs. The Gaenslen test uses a torsion force by applying a superior and posterior force to the right knee and posteriorly directed force to the left knee. Omitting the Gaenslen test has not been shown to compromise diagnostic efficacy of the other tests and can be safely excluded.¹²

A HCP can rule out SIJ dysfunction if these provocation tests are negative. However, the diagnostic predictive value of these tests is subject to variability among HCPs, and their reliability is increased when used in clusters.^9,13

Imaging for the SIJ should begin with anterior/posterior, oblique, and lateral view plain X-rays of the pelvis (Figures 1 and 2), which will rule out other pathologies by identifying other sources of LBP, such as spondylolisthesis or hip osteoarthritis. HCPs should obtain lumbar and pelvis CT images to identify inflammatory or degenerative changes within the SIJ. CT images provide the high resolution that is needed to identify pathologies, such as fractures and tumors within the pelvic ring that could cause similar pain. MRI does not reliably depict a dysfunctional ligamentous apparatus within the SIJ; however, it can help identify inflammatory sacroiliitis, such as is seen in the spondyloarthropathies.^11,14 Recent studies show combined single photon emission tomography and CT (SPECT-CT) might be the most promising imaging modality to reveal mechanical failure of load transfer with increased scintigraphic uptake in the posterior and superior SIJ ligamentous attachments. The joint loses its characteristic “dumbbell” shape in affected patients with about 50% higher uptake than unaffected joints. These findings were evident in patients who experienced pelvic trauma or during the peripartum period.^15,16

Fluoroscopy-guided intra-articular injection of a local anesthetic (lidocaine) and/or a corticosteroid (triamcinolone) has the dual functionality of diagnosis and treatment (Figure 3). It often is considered the most reliable method to diagnose SIJ dysfunction and has the benefit of pain relief for up to 1 year. However, intra-articular injections lack diagnostic validity because the solution often extravasates to extracapsular structures. This confounds the source of the pain and makes it difficult to interpret these diagnostic injections. In addition, the injection might not reach the entire SIJ capsule and could result in a false-negative diagnosis.^17,18 Periarticular injections have been shown to result in better pain relief in patients diagnosed with SIJ dysfunction than intra-articular injections. Periarticular injections also are easier to perform and could be a first-step option for these patients.¹⁹

Treatment

Nonoperative management of SIJ dysfunction includes exercise programs, physical therapy, manual manipulation therapy, sacroiliac belts, and periodic articular injections. Efficacy of these methods is variable, and analgesics often do not significantly benefit this type of pain. Another nonoperative approach is radiofrequency ablation (RFA) of the lumbar dorsal rami and lateral sacral branches, which can vary based on the number of rami treated as well as the technique used. About two-thirds of patients report pain relief after RFA.2 When successful, pain is relieved for 6 to 12 months, which is a temporary yet effective option for patients experiencing SIJ dysfunction.^14,20

Fusion Surgery

Cadaver studies show that biomechanical stabilization of the SIJ leads to decreased range of motion in flexion/extension, lateral bending, and axial rotation. This results in a decreased need for periarticular muscular and ligamentous support, therefore facilitating load transfer across the SIJ.^21,22 Patients undergoing minimally invasive surgery report better pain relief compared with those receiving open surgery at 12 months postoperatively.²³ The 2 main SIJ fusion approaches used are the lateral transarticular and the dorsal approaches. In the dorsal approach, the SIJ is distracted and allograft dowels or titanium cages with graft are inserted into the joint space posteriorly through the back. When approaching laterally, hollow screw implants filled with graft or triangular titanium implants are placed across the joint, accessing the SIJ through the iliac bones using imaging guidance. This lateral transiliac approach using porous titanium triangular rods currently is the most studied technique.²⁴

A recent prospective, multicenter trial included 423 patients with SIJ dysfunction who were randomized to receive SIJ fusion with triangular titanium implants vs a control group who received nonoperative management. Patients in the SIJ fusion group showed substantially greater improvement in pain (81.4%) compared with that of the nonoperative group (26.1%) 6 months after surgery. Pain relief in the SIJ fusion group was maintained at > 80% at 1 and 2 year follow-up, while the nonoperative group’s pain relief decreased to < 10% at the follow-ups. Measures of quality of life and disability also improved for the SIJ fusion group compared with that of the nonoperative group. Patients who were crossed over from conservative management to SIJ fusion after 6 months demonstrated improvements that were similar to those in the SIJ fusion group by the end of the study. Only 3% of patients required surgical revision. The strongest predictor of pain relief after surgery was a diagnostic SIJ anesthetic block of 30 to 60 minutes, which resulted in > 75% pain reduction.^21,25 Additional predictors of successful SIJ fusion include nonsmokers, nonopioid users, and older patients who have a longer time course of SIJ pain.²⁶

Another study investigating the outcomes of SIJ fusion, RFA, and conservative management with a 6-year follow-up demonstrated similar results.²⁷ This further confirms the durability of the surgical group’s outcome, which sustained significant improvement compared with RFA and conservative management group in pain relief, daily function, and opioid use.

HCPs should consider SIJ fusion for patients who have at least 6 months of unsuccessful nonoperative management, significant SIJ pain (> 5 in a 10-point scale), ≥ 3 positive provocation tests, and at least 50% pain relief (> 75% preferred) with diagnostic intra-articular anesthetic injection.¹⁴ It is reasonable for primary care providers to refer these patients to a neurosurgeon or orthopedic spine surgeon for possible fusion. Patients with earlier lumbar/lumbosacral spinal fusions and persistent LBP should be evaluated for potential SIJ dysfunction. SIJ dysfunction after lumbosacral fusion could be considered a form of distal pseudarthrosis resulting from increased motion at the joint. One study found its incidence correlated with the number of segments fused in the lumbar spine.²⁸ Another study found that about one-third of patients with persistent LBP after lumbosacral fusion could be attributed to SIJ dysfunction.²⁹

Case Presentation

A 27-year-old female army veteran presented with bilateral buttock pain, which she described as a dull, aching pain across her sacral region, 8 out of 10 in severity. The pain was in a L5-S1 pattern. The pain was bilateral, with the right side worse than the left, and worsened with lateral bending and load transferring. She reported no numbness, tingling, or weakness.

On physical examination, she had full strength in her lower extremities and intact sensation. She reported tenderness to palpation of the sacrum and SIJ. Her gait was normal. The patient had positive thigh thrust and distraction tests. Lumbar spine X-ray, CT, MRI, and electromyographic studies did not show any pathology. She described little or no relief with analgesics or physical therapy. Previous L4-L5 and L5-S1 facet anesthetic injections and transforaminal epidural steroid injections provided minimal pain relief immediately after the procedures. Bilateral SIJ anesthetic injections under fluoroscopic guidance decreased her pain severity from a 7 to 3 out of 10 for 2 to 3 months before returning to her baseline. Radiofrequency ablation of the right SIJ under fluoroscopy provided moderate relief for about 4 months.

After exhausting nonoperative management for SIJ dysfunction without adequate pain control, the patient was referred to neurosurgery for surgical fusion. The patient was deemed an appropriate surgical candidate and underwent a right-sided SIJ fusion (Figures 4 and 5). At her 6-month and 1-year follow-up appointments, she had lasting pain relief, 2 out of 10.

Conclusion

SIJ dysfunction is widely overlooked because of the difficulty in distinguishing it from other similarly presenting syndromes. However, with a detailed history, appropriate physical maneuvers, imaging, and adequate response to intra-articular anesthetic, providers can reach an accurate diagnosis that will inform subsequent treatments. After failure of nonsurgical methods, patients with SIJ dysfunction should be considered for minimally invasive fusion techniques, which have proven to be a safe, effective, and viable treatment option.

Patients experiencing sacroiliac joint (SIJ) dysfunction might show symptoms that overlap with those seen in lumbar spine pathology. This article reviews diagnostic tools that assist practitioners to discern the true pain generator in patients with low back pain (LBP) and therapeutic approaches when the cause is SIJ dysfunction.

Prevalence

Most of the US population will experience LBP at some point in their lives. A 2002 National Health Interview survey found that more than one-quarter (26.4%) of 31 044 respondents had complained of LBP in the previous 3 months.¹ About 74 million individuals in the US experienced LBP in the past 3 months.¹ A full 10% of the US population is expected to suffer from chronic LBP, and it is estimated that 2.3% of all visits to physicians are related to LBP.¹

The etiology of LBP often is unclear even after thorough clinical and radiographic evaluation because of the myriad possible mechanisms. Degenerative disc disease, facet arthropathy, ligamentous hypertrophy, muscle spasm, hip arthropathy, and SIJ dysfunction are potential pain generators and exact clinical and radiographic correlation is not always possible. Compounding this difficulty is the lack of specificity with current diagnostic techniques. For example, many patients will have disc desiccation or herniation without any LBP or radicular symptoms on radiographic studies, such as X-rays, computed tomography (CT), and magnetic resonance imaging (MRI). As such, providers of patients with diffuse radiographic abnormalities often have to identify a specific pain generator, which might not have any role in the patient’s pain.

Other tests, such as electromyographic studies, positron emission tomography (PET) scans, discography, and epidural steroid injections, can help pinpoint a specific pain generator. These tests might help determine whether the patient has a surgically treatable condition and could help predict whether a patient’s symptoms will respond to surgery.

However, the standard spine surgery workup often fails to identify an obvious pain generator in many individuals. The significant number of patients that fall into this category has prompted spine surgeons to consider other potential etiologies for LBP, and SIJ dysfunction has become a rapidly developing field of research.

Sacroiliac Joint Dysfunction

The SIJ is a bilateral, C-shaped synovial joint surrounded by a fibrous capsule and affixes the sacrum to the ilia. Several sacral ligaments and pelvic muscles support the SIJ. The L5 nerve ventral ramus and lumbosacral trunk pass anteriorly and the S1 nerve ventral ramus passes inferiorly to the joint capsule. The SIJ is innervated by the dorsal rami of L4-S3 nerve roots, transmitting nociception and temperature. Mechanisms of injury to the SIJ could arise from intra- and extra-articular etiologies, including capsular disruption, ligamentous tension, muscular inflammation, shearing, fractures, arthritis, and infection.² Patients could develop SIJ pain spontaneously or after a traumatic event or repetitive shear.³ Risk factors for developing SIJ dysfunction include a history of lumbar fusion, scoliosis, leg length discrepancies, sustained athletic activity, pregnancy, seronegative HLA-B27 spondyloarthropathies, or gait abnormalities. Inflammation of the SIJ and surrounding structures secondary to an environmental insult in susceptible individuals is a common theme among these etiologies.²

Pain from the SIJ is localized to an area of approximately 3 cm × 10 cm that is inferior to the ipsilateral posterior superior iliac spine.⁴ Referred pain maps from SIJ dysfunction extend in the L5-S1 nerve distributions, commonly seen in the buttocks, groin, posterior thigh, and lower leg with radicular symptoms. However, this pain distribution demonstrates extensive variability among patients and bears strong similarities to discogenic or facet joint sources of LBP.^5-7 Direct communication has been shown between the SIJ and adjacent neural structures, namely the L5 nerve, sacral foramina, and the lumbosacral plexus. These direct pathways could explain an inflammatory mechanism for lower extremity symptoms seen in SIJ dysfunction.⁸

The prevalence of SIJ dysfunction among patients with LBP is estimated to be 15% to 30%, an extraordinary number given the total number of patients presenting with LBP every year.⁹ These patients might represent a significant segment of patients with an unrevealing standard spine evaluation. Despite the large number of patients who experience SIJ dysfunction, there is disagreement about optimal methods for diagnosis and treatment.

Diagnosis

The International Association for the Study of Pain has proposed criteria for evaluating patients who have suspected SIJ dysfunction: Pain must be in the SIJ area, should be reproducible by performing specific provocative maneuvers, and must be relieved by injection of local anesthetic into the SIJ.¹⁰ These criteria provide a sound foundation, but in clinical practice, patients often defy categorization.

The presence of pain in the area inferior to the posterior superior iliac spine and lateral to the gluteal fold with pain referral patterns in the L5-S1 nerve distributions is highly sensitive for identifying patients with SIJ dysfunction. Furthermore, pain arising from the SIJ will not be above the level of the L5 nerve sensory distribution. However, this diagnostic finding alone is not specific and might represent other etiologies known to produce similar pain, such as intervertebral discs and facet joints. Patients with SIJ dysfunction often describe their pain as sciatica-like, recurrent, and triggered with bending or twisting motions. It is worsened with any activity loading the SIJ, such as walking, climbing stairs, standing, or sitting upright. SIJ pain might be accompanied by dyspareunia and changes in bladder function because of the nerves involved.¹¹

The use of provocative maneuvers for testing SIJ dysfunction is controversial because of the high rate of false positives and the inability to distinguish whether the SIJ or an adjacent structure is affected. However, the diagnostic utility of specific stress tests has been studied, and clusters of tests are recommended if a health care provider (HCP) suspects SIJ dysfunction. A diagnostic algorithm should first focus on using the distraction test and the thigh thrust test. Distraction is done by applying vertically oriented pressure to the anterior superior iliac spine while aiming posteriorly, therefore distracting the SIJ. During the thigh thrust test the examiner fixates the patient’s sacrum against the table with the left hand and applies a vertical force through the line of the femur aiming posteriorly, producing a posterior shearing force at the SIJ. Studies show that the thigh thrust test is the most sensitive, and the distraction test is the most specific. If both tests are positive, there is reasonable evidence to suggest SIJ dysfunction as the source of LBP.

If there are not 2 positive results, the addition of the compression test, followed by the sacral thrust test also can point to the diagnosis. The compression test is performed with vertical downward force applied to the iliac crest with the patient lying on each side, compressing the SIJ by transverse pressure across the pelvis. The sacral thrust test is performed with vertical force applied to the midline posterior sacrum at its apex directed anteriorly with the patient lying prone, producing a shearing force at the SIJs. The Gaenslen test uses a torsion force by applying a superior and posterior force to the right knee and posteriorly directed force to the left knee. Omitting the Gaenslen test has not been shown to compromise diagnostic efficacy of the other tests and can be safely excluded.¹²

A HCP can rule out SIJ dysfunction if these provocation tests are negative. However, the diagnostic predictive value of these tests is subject to variability among HCPs, and their reliability is increased when used in clusters.^9,13

Imaging for the SIJ should begin with anterior/posterior, oblique, and lateral view plain X-rays of the pelvis (Figures 1 and 2), which will rule out other pathologies by identifying other sources of LBP, such as spondylolisthesis or hip osteoarthritis. HCPs should obtain lumbar and pelvis CT images to identify inflammatory or degenerative changes within the SIJ. CT images provide the high resolution that is needed to identify pathologies, such as fractures and tumors within the pelvic ring that could cause similar pain. MRI does not reliably depict a dysfunctional ligamentous apparatus within the SIJ; however, it can help identify inflammatory sacroiliitis, such as is seen in the spondyloarthropathies.^11,14 Recent studies show combined single photon emission tomography and CT (SPECT-CT) might be the most promising imaging modality to reveal mechanical failure of load transfer with increased scintigraphic uptake in the posterior and superior SIJ ligamentous attachments. The joint loses its characteristic “dumbbell” shape in affected patients with about 50% higher uptake than unaffected joints. These findings were evident in patients who experienced pelvic trauma or during the peripartum period.^15,16

Fluoroscopy-guided intra-articular injection of a local anesthetic (lidocaine) and/or a corticosteroid (triamcinolone) has the dual functionality of diagnosis and treatment (Figure 3). It often is considered the most reliable method to diagnose SIJ dysfunction and has the benefit of pain relief for up to 1 year. However, intra-articular injections lack diagnostic validity because the solution often extravasates to extracapsular structures. This confounds the source of the pain and makes it difficult to interpret these diagnostic injections. In addition, the injection might not reach the entire SIJ capsule and could result in a false-negative diagnosis.^17,18 Periarticular injections have been shown to result in better pain relief in patients diagnosed with SIJ dysfunction than intra-articular injections. Periarticular injections also are easier to perform and could be a first-step option for these patients.¹⁹

Treatment

Nonoperative management of SIJ dysfunction includes exercise programs, physical therapy, manual manipulation therapy, sacroiliac belts, and periodic articular injections. Efficacy of these methods is variable, and analgesics often do not significantly benefit this type of pain. Another nonoperative approach is radiofrequency ablation (RFA) of the lumbar dorsal rami and lateral sacral branches, which can vary based on the number of rami treated as well as the technique used. About two-thirds of patients report pain relief after RFA.2 When successful, pain is relieved for 6 to 12 months, which is a temporary yet effective option for patients experiencing SIJ dysfunction.^14,20

Fusion Surgery

Cadaver studies show that biomechanical stabilization of the SIJ leads to decreased range of motion in flexion/extension, lateral bending, and axial rotation. This results in a decreased need for periarticular muscular and ligamentous support, therefore facilitating load transfer across the SIJ.^21,22 Patients undergoing minimally invasive surgery report better pain relief compared with those receiving open surgery at 12 months postoperatively.²³ The 2 main SIJ fusion approaches used are the lateral transarticular and the dorsal approaches. In the dorsal approach, the SIJ is distracted and allograft dowels or titanium cages with graft are inserted into the joint space posteriorly through the back. When approaching laterally, hollow screw implants filled with graft or triangular titanium implants are placed across the joint, accessing the SIJ through the iliac bones using imaging guidance. This lateral transiliac approach using porous titanium triangular rods currently is the most studied technique.²⁴

A recent prospective, multicenter trial included 423 patients with SIJ dysfunction who were randomized to receive SIJ fusion with triangular titanium implants vs a control group who received nonoperative management. Patients in the SIJ fusion group showed substantially greater improvement in pain (81.4%) compared with that of the nonoperative group (26.1%) 6 months after surgery. Pain relief in the SIJ fusion group was maintained at > 80% at 1 and 2 year follow-up, while the nonoperative group’s pain relief decreased to < 10% at the follow-ups. Measures of quality of life and disability also improved for the SIJ fusion group compared with that of the nonoperative group. Patients who were crossed over from conservative management to SIJ fusion after 6 months demonstrated improvements that were similar to those in the SIJ fusion group by the end of the study. Only 3% of patients required surgical revision. The strongest predictor of pain relief after surgery was a diagnostic SIJ anesthetic block of 30 to 60 minutes, which resulted in > 75% pain reduction.^21,25 Additional predictors of successful SIJ fusion include nonsmokers, nonopioid users, and older patients who have a longer time course of SIJ pain.²⁶

Another study investigating the outcomes of SIJ fusion, RFA, and conservative management with a 6-year follow-up demonstrated similar results.²⁷ This further confirms the durability of the surgical group’s outcome, which sustained significant improvement compared with RFA and conservative management group in pain relief, daily function, and opioid use.

HCPs should consider SIJ fusion for patients who have at least 6 months of unsuccessful nonoperative management, significant SIJ pain (> 5 in a 10-point scale), ≥ 3 positive provocation tests, and at least 50% pain relief (> 75% preferred) with diagnostic intra-articular anesthetic injection.¹⁴ It is reasonable for primary care providers to refer these patients to a neurosurgeon or orthopedic spine surgeon for possible fusion. Patients with earlier lumbar/lumbosacral spinal fusions and persistent LBP should be evaluated for potential SIJ dysfunction. SIJ dysfunction after lumbosacral fusion could be considered a form of distal pseudarthrosis resulting from increased motion at the joint. One study found its incidence correlated with the number of segments fused in the lumbar spine.²⁸ Another study found that about one-third of patients with persistent LBP after lumbosacral fusion could be attributed to SIJ dysfunction.²⁹

Case Presentation

A 27-year-old female army veteran presented with bilateral buttock pain, which she described as a dull, aching pain across her sacral region, 8 out of 10 in severity. The pain was in a L5-S1 pattern. The pain was bilateral, with the right side worse than the left, and worsened with lateral bending and load transferring. She reported no numbness, tingling, or weakness.

On physical examination, she had full strength in her lower extremities and intact sensation. She reported tenderness to palpation of the sacrum and SIJ. Her gait was normal. The patient had positive thigh thrust and distraction tests. Lumbar spine X-ray, CT, MRI, and electromyographic studies did not show any pathology. She described little or no relief with analgesics or physical therapy. Previous L4-L5 and L5-S1 facet anesthetic injections and transforaminal epidural steroid injections provided minimal pain relief immediately after the procedures. Bilateral SIJ anesthetic injections under fluoroscopic guidance decreased her pain severity from a 7 to 3 out of 10 for 2 to 3 months before returning to her baseline. Radiofrequency ablation of the right SIJ under fluoroscopy provided moderate relief for about 4 months.

After exhausting nonoperative management for SIJ dysfunction without adequate pain control, the patient was referred to neurosurgery for surgical fusion. The patient was deemed an appropriate surgical candidate and underwent a right-sided SIJ fusion (Figures 4 and 5). At her 6-month and 1-year follow-up appointments, she had lasting pain relief, 2 out of 10.

Conclusion

SIJ dysfunction is widely overlooked because of the difficulty in distinguishing it from other similarly presenting syndromes. However, with a detailed history, appropriate physical maneuvers, imaging, and adequate response to intra-articular anesthetic, providers can reach an accurate diagnosis that will inform subsequent treatments. After failure of nonsurgical methods, patients with SIJ dysfunction should be considered for minimally invasive fusion techniques, which have proven to be a safe, effective, and viable treatment option.

Curing hepatitis C virus (HCV) infection without addressing the high rate of alcohol use disorder in many patients may undermine the benefits of treatment to long-term liver health, according to the results of a large cohort study.

Katarzyna Bialasiewicz/Thinkstock

Because excess alcohol use is known to accelerate liver disease progression, researchers Risha Irvin, MD, and her colleagues from Johns Hopkins University, Baltimore, examined the prevalence of alcohol use in HCV-infected people who inject drugs (PWID). Their study examined the prevalence and associated correlates of alcohol use (Addictive Behaviors 2019;96:56-61).

They followed a large cohort of 1,623 HCV-antibody positive PWID from 2005 to 2013 from the AIDS Linked to the Intravenous Experience (ALIVE) study. They characterized alcohol use with the Alcohol Use Disorders Identification Test (AUDIT-C) questionnaire. Multivariable logistic regression with generalized estimated equations was used to examine sociodemographic, clinical, and substance use correlates of alcohol use.

At baseline, the median age was 47 years, 67% were men, 81% were black, and 34% were HIV positive. The majority (60%) reported injection drug use in the prior 6 months, while 46% reported noninjection cocaine or heroin, 31% reported street-acquired prescription drugs, and 22% reported marijuana use in the same time period. According to the AUDIT-C results, 41% of the patients reported no alcohol use, 21% reported moderate alcohol use, and 38% reported heavy alcohol use at their baseline visit.

The factors that were significantly associated with heavy alcohol use included male sex, black race, income of $5,000 or less, a Center for Epidemiologic Studies Depression Scale (range 0-60) score of 23 or greater, being homeless, being incarcerated, marijuana use, use of street-acquired prescription drugs, noninjection cocaine/heroin, injection drug use, and cigarette smoking. In a model that included the composite summary variable for substance use intensity, one drug type (adjusted odds ratio, 1.92), two drug types (AOR, 2.93), and three drug types (AOR, 3.65) were significantly associated with heavy alcohol use.

“While clinicians are undoubtedly concerned about any level of alcohol use in the setting of HCV infection due to the acceleration of liver fibrosis, there is particular concern for individuals with heavy alcohol use and their increased risk for cirrhosis and liver failure even after HCV cure. Without intervention, alcohol use will persist after HCV is cured with the potential to undermine the benefit of HCV cure. Therefore, our data point to the need to invest in and develop programs that effectively address alcohol use and co-occurring substance use in this population of PWID with HCV,” the researchers concluded.

The study was supported by the U.S. National Institute on Drug Abuse, the National Institute of Allergy and Infectious Diseases, and the National Institute on Alcohol Abuse and Alcoholism. The authors declared that they had no conflicts.

mlesney@mdedge.com

SOURCE: Irvin R et al. Addictive Behaviors. 2019;96:56-61.

Curing hepatitis C virus (HCV) infection without addressing the high rate of alcohol use disorder in many patients may undermine the benefits of treatment to long-term liver health, according to the results of a large cohort study.

Katarzyna Bialasiewicz/Thinkstock

Because excess alcohol use is known to accelerate liver disease progression, researchers Risha Irvin, MD, and her colleagues from Johns Hopkins University, Baltimore, examined the prevalence of alcohol use in HCV-infected people who inject drugs (PWID). Their study examined the prevalence and associated correlates of alcohol use (Addictive Behaviors 2019;96:56-61).

They followed a large cohort of 1,623 HCV-antibody positive PWID from 2005 to 2013 from the AIDS Linked to the Intravenous Experience (ALIVE) study. They characterized alcohol use with the Alcohol Use Disorders Identification Test (AUDIT-C) questionnaire. Multivariable logistic regression with generalized estimated equations was used to examine sociodemographic, clinical, and substance use correlates of alcohol use.

At baseline, the median age was 47 years, 67% were men, 81% were black, and 34% were HIV positive. The majority (60%) reported injection drug use in the prior 6 months, while 46% reported noninjection cocaine or heroin, 31% reported street-acquired prescription drugs, and 22% reported marijuana use in the same time period. According to the AUDIT-C results, 41% of the patients reported no alcohol use, 21% reported moderate alcohol use, and 38% reported heavy alcohol use at their baseline visit.

The factors that were significantly associated with heavy alcohol use included male sex, black race, income of $5,000 or less, a Center for Epidemiologic Studies Depression Scale (range 0-60) score of 23 or greater, being homeless, being incarcerated, marijuana use, use of street-acquired prescription drugs, noninjection cocaine/heroin, injection drug use, and cigarette smoking. In a model that included the composite summary variable for substance use intensity, one drug type (adjusted odds ratio, 1.92), two drug types (AOR, 2.93), and three drug types (AOR, 3.65) were significantly associated with heavy alcohol use.

“While clinicians are undoubtedly concerned about any level of alcohol use in the setting of HCV infection due to the acceleration of liver fibrosis, there is particular concern for individuals with heavy alcohol use and their increased risk for cirrhosis and liver failure even after HCV cure. Without intervention, alcohol use will persist after HCV is cured with the potential to undermine the benefit of HCV cure. Therefore, our data point to the need to invest in and develop programs that effectively address alcohol use and co-occurring substance use in this population of PWID with HCV,” the researchers concluded.

The study was supported by the U.S. National Institute on Drug Abuse, the National Institute of Allergy and Infectious Diseases, and the National Institute on Alcohol Abuse and Alcoholism. The authors declared that they had no conflicts.

mlesney@mdedge.com

SOURCE: Irvin R et al. Addictive Behaviors. 2019;96:56-61.

Curing hepatitis C virus (HCV) infection without addressing the high rate of alcohol use disorder in many patients may undermine the benefits of treatment to long-term liver health, according to the results of a large cohort study.

Katarzyna Bialasiewicz/Thinkstock

Because excess alcohol use is known to accelerate liver disease progression, researchers Risha Irvin, MD, and her colleagues from Johns Hopkins University, Baltimore, examined the prevalence of alcohol use in HCV-infected people who inject drugs (PWID). Their study examined the prevalence and associated correlates of alcohol use (Addictive Behaviors 2019;96:56-61).

They followed a large cohort of 1,623 HCV-antibody positive PWID from 2005 to 2013 from the AIDS Linked to the Intravenous Experience (ALIVE) study. They characterized alcohol use with the Alcohol Use Disorders Identification Test (AUDIT-C) questionnaire. Multivariable logistic regression with generalized estimated equations was used to examine sociodemographic, clinical, and substance use correlates of alcohol use.

At baseline, the median age was 47 years, 67% were men, 81% were black, and 34% were HIV positive. The majority (60%) reported injection drug use in the prior 6 months, while 46% reported noninjection cocaine or heroin, 31% reported street-acquired prescription drugs, and 22% reported marijuana use in the same time period. According to the AUDIT-C results, 41% of the patients reported no alcohol use, 21% reported moderate alcohol use, and 38% reported heavy alcohol use at their baseline visit.

The factors that were significantly associated with heavy alcohol use included male sex, black race, income of $5,000 or less, a Center for Epidemiologic Studies Depression Scale (range 0-60) score of 23 or greater, being homeless, being incarcerated, marijuana use, use of street-acquired prescription drugs, noninjection cocaine/heroin, injection drug use, and cigarette smoking. In a model that included the composite summary variable for substance use intensity, one drug type (adjusted odds ratio, 1.92), two drug types (AOR, 2.93), and three drug types (AOR, 3.65) were significantly associated with heavy alcohol use.

“While clinicians are undoubtedly concerned about any level of alcohol use in the setting of HCV infection due to the acceleration of liver fibrosis, there is particular concern for individuals with heavy alcohol use and their increased risk for cirrhosis and liver failure even after HCV cure. Without intervention, alcohol use will persist after HCV is cured with the potential to undermine the benefit of HCV cure. Therefore, our data point to the need to invest in and develop programs that effectively address alcohol use and co-occurring substance use in this population of PWID with HCV,” the researchers concluded.

The study was supported by the U.S. National Institute on Drug Abuse, the National Institute of Allergy and Infectious Diseases, and the National Institute on Alcohol Abuse and Alcoholism. The authors declared that they had no conflicts.

mlesney@mdedge.com

SOURCE: Irvin R et al. Addictive Behaviors. 2019;96:56-61.

Stroke is a leading cause of death and long-term disability in the US.¹ Quality improvement efforts for acute stroke care delivery have successfully led to increased rates of thrombolytic utilization.² Increasing attention is now being paid to additional quality metrics for stroke care, including hospital management and initiation of appropriate secondary stroke prevention measures at discharge. Many organizations, including the Veterans Health Administration (VHA), use these measures to monitor health care quality and certify centers that are committed to excellence in stroke care.^3-6 It is anticipated that collection, evaluation, and feedback from these data may lead to improvements in outcomes after stroke.⁷

Patients who experience onset of stroke symptoms while already admitted to a hospital may be uniquely suited for quality improvement strategies. In-hospital strokes (IHS) are not uncommon and have been associated with higher stroke severity and increased mortality compared with patients with stroke symptoms prior to arriving at the emergency department (ED).^8-10 A potential reason for the higher observed mortality is that patients with IHS may have poorer access to acute stroke resources, such as stroke teams and neuroimaging, as well as increased rates of medical comorbidities.^9,11,12 Furthermore, stroke management protocols are typically created based on ED resources, which may not be equivalent to resources available on inpatient settings.

Although many studies have examined clinical characteristics of patients with IHS, few studies have looked at the quality of stroke care for IHS. Information on stroke quality data is even more limited in VHA hospitals due to the small number of admitted patients with stroke.¹³ VHA released a directive on Acute Stroke Treatment (Directive 2011-03) in 2011 with a recent update in 2018, which aimed to implement quality improvement strategies for stroke care in VHA hospitals.¹⁴ Although focusing primarily on acute stroke care in the ED, this directive has led to increased awareness of areas for improvement, particularly among larger VHA hospitals. Prior to this directive, although national stroke guidelines were well-defined, more variability likely existed in stroke protocols and the manner in which stroke care was delivered across care settings. As efforts to measure and improve stroke care evolve, it is important to ensure that strategies used in ED settings also are implemented for patients already admitted to the hospital. This study seeks to define the quality of care in VHA hospitals between patients having an in-hospital ischemic stroke compared with those presenting to the ED.

Methods

As a secondary analysis, we examined stroke care quality data from an 11-site VHA stroke quality improvement study.¹⁵ Sites participating in this study were high stroke volume VHA hospitals from various geographic regions of the US. This study collected data on ICD-9 discharge diagnosis-defined ischemic stroke admissions between January 2009 and June 2012. Patient charts were reviewed by a group of central, trained abstractors who collected information on patient demographics, clinical history, and stroke characteristics. Stroke severity was defined using the National Institutes of Health Stroke Scale (NIHSS), assessed by standardized retrospective review of admission physical examination documentation.¹⁶ A multidisciplinary team defined 11 stroke quality indicators (QIs; the 8 Joint Commission indictors and 3 additional indicators: smoking cessation and dysphagia screening, and NIHSS assessment), and the chart abstractors’ data were used to evaluate eligibility and passing rates for each QI.

For our analysis, patients were stratified into 2 categories: patients admitted to the hospital for another diagnosis who developed an IHS, and patients presenting with stroke to the ED. We excluded patients transferred from other facilities. We then compared the demographic and clinical features of the 2 groups as well as eligibility and passing rates for each of the 11 QIs. Patients were recorded as eligible if they did not have any clinical contraindication to receiving the assessment or intervention measured by the quality metric. Passing rates were defined by the presence of clear documentation in the patient record that the quality metric was met or fulfilled. Comparisons were made using nonparametric Mann-Whitney U tests and chi-square tests. All tests were performed at α .05 level.

Results

A total of 1823 patients were included in this analysis: 35 IHS and 1788 ED strokes. The 2 groups did not differ with respect to age, race, or sex (Table 1). Patients with IHS had higher stroke severity (mean NIHSS 11.3 vs 5.1, P <.01) and longer length of stay than did ED patients with stroke (mean 12.8 vs 7.3 days, P < .01). Patients with IHS also were less likely to be discharged home when compared with ED patients with stroke (34.3% vs 63.8%, P < .01).

Table 2 summarizes our findings on eligibility and passing rates for the 11 QIs. For acute care metrics, we found that stroke severity documentation rates did not differ but were low for each patient group (51% vs 48%, P = .07). Patients with IHS were more likely to be eligible for IV tissue plasminogen activator (tPA; P < .01) although utilization rates did not differ. Only 2% of ED patients met eligibility criteria to receive tPA (36 of 1788), and among these patients only 16 actually received the drug. By comparison, 5 of 6 of eligible patients with IHS received tPA. Rates of dysphagia screening also were low for both groups, and patients with IHS were less likely to receive this screen prior to initiation of oral intake than were ED patients with stroke (27% vs 50%, P = .01).

Beyond the acute period, we found that patients with IHS were less likely than were ED patients with stroke to be eligible to receive antithrombotic therapy by 2 days after their initial stroke evaluation (74% vs 96%, P < .01), although treatment rates were similar between the 2 groups (P = .99). In patients with documented atrial fibrillation, initiation of anticoagulation therapy also did not differ (P = .99). The 2 groups were similar with respect to initiation of venous thromboembolism (VTE) prophylaxis (P = .596) and evaluation for rehabilitation needs (P = .42). Although rates of smoking cessation counseling and stroke education prior to discharge did not differ, overall rates of stroke education were very low for both groups (25% vs 36%, P = .55).

Similar to initiation of antithrombotic therapy in the hospital, we found lower rates of eligibility to receive antithrombotic therapy on discharge in the IHS group when compared with the ED group (77% vs 93%, P = .04). However, actual treatment initiation rates did not differ (P = .12). Use of lipid-lowering agents was similar for the 2 groups (P = .12).

Discussion

Our study found that veterans who develop an IHS received similar quality of care as did those presenting to the ED with stroke symptoms for many QIs, although there were some notable differences. We were pleased to find that overall rates of secondary stroke prevention initiation (antithrombotic and statin therapy), VTE prophylaxis, rehabilitation evaluations, and smoking cessation counseling were high for both groups, in keeping with evidence-based guidelines.¹⁷ This likely reflected the fact that these metrics typically involve care outside of the acute period and are less likely to be influenced by the location of initial stroke evaluation. Furthermore, efforts to improve smoking cessation and VTE prophylaxis are not exclusive to stroke care and have been the target of several nonstroke quality projects in the VHA. Many aspects of acute stroke care did differ, and present opportunities for quality improvement in the future.

In our sample, patients with IHS had higher IV thrombolytic eligibility, which has not typically been reported in other samples.^10,11,18 In these studies, hospitalized patients have been reported to more often have contraindications to tPA, such as recent surgery or lack of stroke symptom recognition due to delirium or medication effects. Interestingly, patients presenting to VHA EDs had extremely low rates of tPA eligibility (2%), which is lower than many reported estimates of tPA eligibility outside of the VHA.^19,20 This may be due to multiple influences, such as geographic barriers, patient perceptions about stroke symptoms, access to emergency medical services (EMS), EMS routing patterns, and social/cultural factors. Although not statistically significant due to small sample size, tPA use also was twice as high in the IHS group.

Given that a significant proportion of patients with IHS in the VHA system may be eligible for acute thrombolysis, our findings highlight the need for acute stroke protocols to ensure that patients with IHS receive the same rapid stroke assessment and access to thrombolytics as do patients evaluated in the ED. Further investigation is needed to determine whether there are unique features of patients with IHS in VHA hospitals, which may make them more eligible for IV thrombolysis.

Dysphagia is associated with increased risks for aspiration pneumonia in stroke patients.²¹ We found that patients with IHS were less likely to receive dysphagia screening compared with that of stroke patients admitted through the ED. This finding is consistent with the fact that care for patients with IHS is less frequently guided by specific stroke care protocols and algorithms that are more often used in EDs.^8,11 Although attention to swallowing function may lead to improved outcomes in stroke, this can be easily overlooked in patients with IHS.²² However, low dysphagia screening also was found in patients admitted through the ED, suggesting that low screening rates cannot be solely explained by differences in where the initial stroke evaluation is occurring. These findings suggest a need for novel approaches to dysphagia screening in VHA stroke patients that can be universally implemented throughout the hospital.

Finally, we also found very low rates of stroke education prior to discharge for both groups. Given the risk of stroke recurrence and the overall poor level of public knowledge about stroke, providing patients with stroke with formal oral and written information on stroke is a critical component of secondary prevention.^23,24 Educational tools, including those that are veteran specific, are now available for use in VHA hospitals and should be incorporated into quality improvement strategies for stroke care in VHA hospitals.

In 2012, the VHA Acute Stroke Treatment Directive was published in an effort to improve stroke care systemwide. Several of the metrics examined in this study are addressed in this directive. The data presented in this study is one of the only samples of stroke quality metrics within the VHA that largely predates the directive and can serve as a baseline comparator for future work examining stroke care after release of the directive. At present, although continuous internal reviews of quality data are ongoing, longitudinal description of stroke care quality since publication of the directive will help to inform future efforts to improve stroke care for veterans.

Limitations

Despite the strength of being a multicenter sampling of stroke care in high volume VHA hospitals, our study had several limitations. The IHS sample size was small, which limited our ability to evaluate differences between the groups, to evaluate generalizability, and account for estimation error.¹³ It is possible that differences existed between the groups that could not be observed in this sample due to small size (type II error) or that patient-specific characteristics not captured by these data could influence these metrics. Assessments of eligibility and passing were based on retrospective chart review and post hoc coding. Our sample assessed only patients who presented to larger VHA hospitals with higher stroke volumes, thus these findings may not be generalizable to smaller VHA hospitals with less systematized stroke care. This sample did not describe the specialty care services that were received by each patient, which may have influenced their stroke care. Finally, this study is an analysis of use of QIs in stroke care and did not examine how these indicators affect outcomes.

Conclusion

Despite reassuring findings for several inpatient ischemic stroke quality metrics, we found several differences in stroke care between patients with IHS compared with those presenting to the ED, emphasizing the need for standardized approaches to stroke care regardless of care setting. Although patients with IHS may be more likely to be eligible for tPA, these patients received dysphagia screening and less often than did ED patients with stroke. Ongoing quality initiatives should continue to place emphasis on improving all quality metrics (particularly dysphagia screening, stroke severity documentation, and stroke education) for patients with stroke at VHA hospitals across all care settings. Future work will be needed to examine how specific patient characteristics and revisions to stroke protocols may affect stroke quality metrics and outcomes between patients with IHS and those presenting to the ED.

Acknowledgments

The authors would like to thank Danielle Sager for her contributions to this project.

Stroke is a leading cause of death and long-term disability in the US.¹ Quality improvement efforts for acute stroke care delivery have successfully led to increased rates of thrombolytic utilization.² Increasing attention is now being paid to additional quality metrics for stroke care, including hospital management and initiation of appropriate secondary stroke prevention measures at discharge. Many organizations, including the Veterans Health Administration (VHA), use these measures to monitor health care quality and certify centers that are committed to excellence in stroke care.^3-6 It is anticipated that collection, evaluation, and feedback from these data may lead to improvements in outcomes after stroke.⁷

Patients who experience onset of stroke symptoms while already admitted to a hospital may be uniquely suited for quality improvement strategies. In-hospital strokes (IHS) are not uncommon and have been associated with higher stroke severity and increased mortality compared with patients with stroke symptoms prior to arriving at the emergency department (ED).^8-10 A potential reason for the higher observed mortality is that patients with IHS may have poorer access to acute stroke resources, such as stroke teams and neuroimaging, as well as increased rates of medical comorbidities.^9,11,12 Furthermore, stroke management protocols are typically created based on ED resources, which may not be equivalent to resources available on inpatient settings.

Although many studies have examined clinical characteristics of patients with IHS, few studies have looked at the quality of stroke care for IHS. Information on stroke quality data is even more limited in VHA hospitals due to the small number of admitted patients with stroke.¹³ VHA released a directive on Acute Stroke Treatment (Directive 2011-03) in 2011 with a recent update in 2018, which aimed to implement quality improvement strategies for stroke care in VHA hospitals.¹⁴ Although focusing primarily on acute stroke care in the ED, this directive has led to increased awareness of areas for improvement, particularly among larger VHA hospitals. Prior to this directive, although national stroke guidelines were well-defined, more variability likely existed in stroke protocols and the manner in which stroke care was delivered across care settings. As efforts to measure and improve stroke care evolve, it is important to ensure that strategies used in ED settings also are implemented for patients already admitted to the hospital. This study seeks to define the quality of care in VHA hospitals between patients having an in-hospital ischemic stroke compared with those presenting to the ED.

Methods

As a secondary analysis, we examined stroke care quality data from an 11-site VHA stroke quality improvement study.¹⁵ Sites participating in this study were high stroke volume VHA hospitals from various geographic regions of the US. This study collected data on ICD-9 discharge diagnosis-defined ischemic stroke admissions between January 2009 and June 2012. Patient charts were reviewed by a group of central, trained abstractors who collected information on patient demographics, clinical history, and stroke characteristics. Stroke severity was defined using the National Institutes of Health Stroke Scale (NIHSS), assessed by standardized retrospective review of admission physical examination documentation.¹⁶ A multidisciplinary team defined 11 stroke quality indicators (QIs; the 8 Joint Commission indictors and 3 additional indicators: smoking cessation and dysphagia screening, and NIHSS assessment), and the chart abstractors’ data were used to evaluate eligibility and passing rates for each QI.

For our analysis, patients were stratified into 2 categories: patients admitted to the hospital for another diagnosis who developed an IHS, and patients presenting with stroke to the ED. We excluded patients transferred from other facilities. We then compared the demographic and clinical features of the 2 groups as well as eligibility and passing rates for each of the 11 QIs. Patients were recorded as eligible if they did not have any clinical contraindication to receiving the assessment or intervention measured by the quality metric. Passing rates were defined by the presence of clear documentation in the patient record that the quality metric was met or fulfilled. Comparisons were made using nonparametric Mann-Whitney U tests and chi-square tests. All tests were performed at α .05 level.

Results

A total of 1823 patients were included in this analysis: 35 IHS and 1788 ED strokes. The 2 groups did not differ with respect to age, race, or sex (Table 1). Patients with IHS had higher stroke severity (mean NIHSS 11.3 vs 5.1, P <.01) and longer length of stay than did ED patients with stroke (mean 12.8 vs 7.3 days, P < .01). Patients with IHS also were less likely to be discharged home when compared with ED patients with stroke (34.3% vs 63.8%, P < .01).

Table 2 summarizes our findings on eligibility and passing rates for the 11 QIs. For acute care metrics, we found that stroke severity documentation rates did not differ but were low for each patient group (51% vs 48%, P = .07). Patients with IHS were more likely to be eligible for IV tissue plasminogen activator (tPA; P < .01) although utilization rates did not differ. Only 2% of ED patients met eligibility criteria to receive tPA (36 of 1788), and among these patients only 16 actually received the drug. By comparison, 5 of 6 of eligible patients with IHS received tPA. Rates of dysphagia screening also were low for both groups, and patients with IHS were less likely to receive this screen prior to initiation of oral intake than were ED patients with stroke (27% vs 50%, P = .01).

Beyond the acute period, we found that patients with IHS were less likely than were ED patients with stroke to be eligible to receive antithrombotic therapy by 2 days after their initial stroke evaluation (74% vs 96%, P < .01), although treatment rates were similar between the 2 groups (P = .99). In patients with documented atrial fibrillation, initiation of anticoagulation therapy also did not differ (P = .99). The 2 groups were similar with respect to initiation of venous thromboembolism (VTE) prophylaxis (P = .596) and evaluation for rehabilitation needs (P = .42). Although rates of smoking cessation counseling and stroke education prior to discharge did not differ, overall rates of stroke education were very low for both groups (25% vs 36%, P = .55).

Similar to initiation of antithrombotic therapy in the hospital, we found lower rates of eligibility to receive antithrombotic therapy on discharge in the IHS group when compared with the ED group (77% vs 93%, P = .04). However, actual treatment initiation rates did not differ (P = .12). Use of lipid-lowering agents was similar for the 2 groups (P = .12).

Discussion

Our study found that veterans who develop an IHS received similar quality of care as did those presenting to the ED with stroke symptoms for many QIs, although there were some notable differences. We were pleased to find that overall rates of secondary stroke prevention initiation (antithrombotic and statin therapy), VTE prophylaxis, rehabilitation evaluations, and smoking cessation counseling were high for both groups, in keeping with evidence-based guidelines.¹⁷ This likely reflected the fact that these metrics typically involve care outside of the acute period and are less likely to be influenced by the location of initial stroke evaluation. Furthermore, efforts to improve smoking cessation and VTE prophylaxis are not exclusive to stroke care and have been the target of several nonstroke quality projects in the VHA. Many aspects of acute stroke care did differ, and present opportunities for quality improvement in the future.

In our sample, patients with IHS had higher IV thrombolytic eligibility, which has not typically been reported in other samples.^10,11,18 In these studies, hospitalized patients have been reported to more often have contraindications to tPA, such as recent surgery or lack of stroke symptom recognition due to delirium or medication effects. Interestingly, patients presenting to VHA EDs had extremely low rates of tPA eligibility (2%), which is lower than many reported estimates of tPA eligibility outside of the VHA.^19,20 This may be due to multiple influences, such as geographic barriers, patient perceptions about stroke symptoms, access to emergency medical services (EMS), EMS routing patterns, and social/cultural factors. Although not statistically significant due to small sample size, tPA use also was twice as high in the IHS group.

Given that a significant proportion of patients with IHS in the VHA system may be eligible for acute thrombolysis, our findings highlight the need for acute stroke protocols to ensure that patients with IHS receive the same rapid stroke assessment and access to thrombolytics as do patients evaluated in the ED. Further investigation is needed to determine whether there are unique features of patients with IHS in VHA hospitals, which may make them more eligible for IV thrombolysis.

Dysphagia is associated with increased risks for aspiration pneumonia in stroke patients.²¹ We found that patients with IHS were less likely to receive dysphagia screening compared with that of stroke patients admitted through the ED. This finding is consistent with the fact that care for patients with IHS is less frequently guided by specific stroke care protocols and algorithms that are more often used in EDs.^8,11 Although attention to swallowing function may lead to improved outcomes in stroke, this can be easily overlooked in patients with IHS.²² However, low dysphagia screening also was found in patients admitted through the ED, suggesting that low screening rates cannot be solely explained by differences in where the initial stroke evaluation is occurring. These findings suggest a need for novel approaches to dysphagia screening in VHA stroke patients that can be universally implemented throughout the hospital.

Finally, we also found very low rates of stroke education prior to discharge for both groups. Given the risk of stroke recurrence and the overall poor level of public knowledge about stroke, providing patients with stroke with formal oral and written information on stroke is a critical component of secondary prevention.^23,24 Educational tools, including those that are veteran specific, are now available for use in VHA hospitals and should be incorporated into quality improvement strategies for stroke care in VHA hospitals.

In 2012, the VHA Acute Stroke Treatment Directive was published in an effort to improve stroke care systemwide. Several of the metrics examined in this study are addressed in this directive. The data presented in this study is one of the only samples of stroke quality metrics within the VHA that largely predates the directive and can serve as a baseline comparator for future work examining stroke care after release of the directive. At present, although continuous internal reviews of quality data are ongoing, longitudinal description of stroke care quality since publication of the directive will help to inform future efforts to improve stroke care for veterans.

Limitations

Despite the strength of being a multicenter sampling of stroke care in high volume VHA hospitals, our study had several limitations. The IHS sample size was small, which limited our ability to evaluate differences between the groups, to evaluate generalizability, and account for estimation error.¹³ It is possible that differences existed between the groups that could not be observed in this sample due to small size (type II error) or that patient-specific characteristics not captured by these data could influence these metrics. Assessments of eligibility and passing were based on retrospective chart review and post hoc coding. Our sample assessed only patients who presented to larger VHA hospitals with higher stroke volumes, thus these findings may not be generalizable to smaller VHA hospitals with less systematized stroke care. This sample did not describe the specialty care services that were received by each patient, which may have influenced their stroke care. Finally, this study is an analysis of use of QIs in stroke care and did not examine how these indicators affect outcomes.

Conclusion

Despite reassuring findings for several inpatient ischemic stroke quality metrics, we found several differences in stroke care between patients with IHS compared with those presenting to the ED, emphasizing the need for standardized approaches to stroke care regardless of care setting. Although patients with IHS may be more likely to be eligible for tPA, these patients received dysphagia screening and less often than did ED patients with stroke. Ongoing quality initiatives should continue to place emphasis on improving all quality metrics (particularly dysphagia screening, stroke severity documentation, and stroke education) for patients with stroke at VHA hospitals across all care settings. Future work will be needed to examine how specific patient characteristics and revisions to stroke protocols may affect stroke quality metrics and outcomes between patients with IHS and those presenting to the ED.

Acknowledgments

The authors would like to thank Danielle Sager for her contributions to this project.

Stroke is a leading cause of death and long-term disability in the US.¹ Quality improvement efforts for acute stroke care delivery have successfully led to increased rates of thrombolytic utilization.² Increasing attention is now being paid to additional quality metrics for stroke care, including hospital management and initiation of appropriate secondary stroke prevention measures at discharge. Many organizations, including the Veterans Health Administration (VHA), use these measures to monitor health care quality and certify centers that are committed to excellence in stroke care.^3-6 It is anticipated that collection, evaluation, and feedback from these data may lead to improvements in outcomes after stroke.⁷

Patients who experience onset of stroke symptoms while already admitted to a hospital may be uniquely suited for quality improvement strategies. In-hospital strokes (IHS) are not uncommon and have been associated with higher stroke severity and increased mortality compared with patients with stroke symptoms prior to arriving at the emergency department (ED).^8-10 A potential reason for the higher observed mortality is that patients with IHS may have poorer access to acute stroke resources, such as stroke teams and neuroimaging, as well as increased rates of medical comorbidities.^9,11,12 Furthermore, stroke management protocols are typically created based on ED resources, which may not be equivalent to resources available on inpatient settings.

Although many studies have examined clinical characteristics of patients with IHS, few studies have looked at the quality of stroke care for IHS. Information on stroke quality data is even more limited in VHA hospitals due to the small number of admitted patients with stroke.¹³ VHA released a directive on Acute Stroke Treatment (Directive 2011-03) in 2011 with a recent update in 2018, which aimed to implement quality improvement strategies for stroke care in VHA hospitals.¹⁴ Although focusing primarily on acute stroke care in the ED, this directive has led to increased awareness of areas for improvement, particularly among larger VHA hospitals. Prior to this directive, although national stroke guidelines were well-defined, more variability likely existed in stroke protocols and the manner in which stroke care was delivered across care settings. As efforts to measure and improve stroke care evolve, it is important to ensure that strategies used in ED settings also are implemented for patients already admitted to the hospital. This study seeks to define the quality of care in VHA hospitals between patients having an in-hospital ischemic stroke compared with those presenting to the ED.

Methods

As a secondary analysis, we examined stroke care quality data from an 11-site VHA stroke quality improvement study.¹⁵ Sites participating in this study were high stroke volume VHA hospitals from various geographic regions of the US. This study collected data on ICD-9 discharge diagnosis-defined ischemic stroke admissions between January 2009 and June 2012. Patient charts were reviewed by a group of central, trained abstractors who collected information on patient demographics, clinical history, and stroke characteristics. Stroke severity was defined using the National Institutes of Health Stroke Scale (NIHSS), assessed by standardized retrospective review of admission physical examination documentation.¹⁶ A multidisciplinary team defined 11 stroke quality indicators (QIs; the 8 Joint Commission indictors and 3 additional indicators: smoking cessation and dysphagia screening, and NIHSS assessment), and the chart abstractors’ data were used to evaluate eligibility and passing rates for each QI.

For our analysis, patients were stratified into 2 categories: patients admitted to the hospital for another diagnosis who developed an IHS, and patients presenting with stroke to the ED. We excluded patients transferred from other facilities. We then compared the demographic and clinical features of the 2 groups as well as eligibility and passing rates for each of the 11 QIs. Patients were recorded as eligible if they did not have any clinical contraindication to receiving the assessment or intervention measured by the quality metric. Passing rates were defined by the presence of clear documentation in the patient record that the quality metric was met or fulfilled. Comparisons were made using nonparametric Mann-Whitney U tests and chi-square tests. All tests were performed at α .05 level.

Results

A total of 1823 patients were included in this analysis: 35 IHS and 1788 ED strokes. The 2 groups did not differ with respect to age, race, or sex (Table 1). Patients with IHS had higher stroke severity (mean NIHSS 11.3 vs 5.1, P <.01) and longer length of stay than did ED patients with stroke (mean 12.8 vs 7.3 days, P < .01). Patients with IHS also were less likely to be discharged home when compared with ED patients with stroke (34.3% vs 63.8%, P < .01).

Table 2 summarizes our findings on eligibility and passing rates for the 11 QIs. For acute care metrics, we found that stroke severity documentation rates did not differ but were low for each patient group (51% vs 48%, P = .07). Patients with IHS were more likely to be eligible for IV tissue plasminogen activator (tPA; P < .01) although utilization rates did not differ. Only 2% of ED patients met eligibility criteria to receive tPA (36 of 1788), and among these patients only 16 actually received the drug. By comparison, 5 of 6 of eligible patients with IHS received tPA. Rates of dysphagia screening also were low for both groups, and patients with IHS were less likely to receive this screen prior to initiation of oral intake than were ED patients with stroke (27% vs 50%, P = .01).

Beyond the acute period, we found that patients with IHS were less likely than were ED patients with stroke to be eligible to receive antithrombotic therapy by 2 days after their initial stroke evaluation (74% vs 96%, P < .01), although treatment rates were similar between the 2 groups (P = .99). In patients with documented atrial fibrillation, initiation of anticoagulation therapy also did not differ (P = .99). The 2 groups were similar with respect to initiation of venous thromboembolism (VTE) prophylaxis (P = .596) and evaluation for rehabilitation needs (P = .42). Although rates of smoking cessation counseling and stroke education prior to discharge did not differ, overall rates of stroke education were very low for both groups (25% vs 36%, P = .55).

Similar to initiation of antithrombotic therapy in the hospital, we found lower rates of eligibility to receive antithrombotic therapy on discharge in the IHS group when compared with the ED group (77% vs 93%, P = .04). However, actual treatment initiation rates did not differ (P = .12). Use of lipid-lowering agents was similar for the 2 groups (P = .12).

Discussion

Our study found that veterans who develop an IHS received similar quality of care as did those presenting to the ED with stroke symptoms for many QIs, although there were some notable differences. We were pleased to find that overall rates of secondary stroke prevention initiation (antithrombotic and statin therapy), VTE prophylaxis, rehabilitation evaluations, and smoking cessation counseling were high for both groups, in keeping with evidence-based guidelines.¹⁷ This likely reflected the fact that these metrics typically involve care outside of the acute period and are less likely to be influenced by the location of initial stroke evaluation. Furthermore, efforts to improve smoking cessation and VTE prophylaxis are not exclusive to stroke care and have been the target of several nonstroke quality projects in the VHA. Many aspects of acute stroke care did differ, and present opportunities for quality improvement in the future.

In our sample, patients with IHS had higher IV thrombolytic eligibility, which has not typically been reported in other samples.^10,11,18 In these studies, hospitalized patients have been reported to more often have contraindications to tPA, such as recent surgery or lack of stroke symptom recognition due to delirium or medication effects. Interestingly, patients presenting to VHA EDs had extremely low rates of tPA eligibility (2%), which is lower than many reported estimates of tPA eligibility outside of the VHA.^19,20 This may be due to multiple influences, such as geographic barriers, patient perceptions about stroke symptoms, access to emergency medical services (EMS), EMS routing patterns, and social/cultural factors. Although not statistically significant due to small sample size, tPA use also was twice as high in the IHS group.

Given that a significant proportion of patients with IHS in the VHA system may be eligible for acute thrombolysis, our findings highlight the need for acute stroke protocols to ensure that patients with IHS receive the same rapid stroke assessment and access to thrombolytics as do patients evaluated in the ED. Further investigation is needed to determine whether there are unique features of patients with IHS in VHA hospitals, which may make them more eligible for IV thrombolysis.

Dysphagia is associated with increased risks for aspiration pneumonia in stroke patients.²¹ We found that patients with IHS were less likely to receive dysphagia screening compared with that of stroke patients admitted through the ED. This finding is consistent with the fact that care for patients with IHS is less frequently guided by specific stroke care protocols and algorithms that are more often used in EDs.^8,11 Although attention to swallowing function may lead to improved outcomes in stroke, this can be easily overlooked in patients with IHS.²² However, low dysphagia screening also was found in patients admitted through the ED, suggesting that low screening rates cannot be solely explained by differences in where the initial stroke evaluation is occurring. These findings suggest a need for novel approaches to dysphagia screening in VHA stroke patients that can be universally implemented throughout the hospital.

Finally, we also found very low rates of stroke education prior to discharge for both groups. Given the risk of stroke recurrence and the overall poor level of public knowledge about stroke, providing patients with stroke with formal oral and written information on stroke is a critical component of secondary prevention.^23,24 Educational tools, including those that are veteran specific, are now available for use in VHA hospitals and should be incorporated into quality improvement strategies for stroke care in VHA hospitals.

In 2012, the VHA Acute Stroke Treatment Directive was published in an effort to improve stroke care systemwide. Several of the metrics examined in this study are addressed in this directive. The data presented in this study is one of the only samples of stroke quality metrics within the VHA that largely predates the directive and can serve as a baseline comparator for future work examining stroke care after release of the directive. At present, although continuous internal reviews of quality data are ongoing, longitudinal description of stroke care quality since publication of the directive will help to inform future efforts to improve stroke care for veterans.

Limitations

Despite the strength of being a multicenter sampling of stroke care in high volume VHA hospitals, our study had several limitations. The IHS sample size was small, which limited our ability to evaluate differences between the groups, to evaluate generalizability, and account for estimation error.¹³ It is possible that differences existed between the groups that could not be observed in this sample due to small size (type II error) or that patient-specific characteristics not captured by these data could influence these metrics. Assessments of eligibility and passing were based on retrospective chart review and post hoc coding. Our sample assessed only patients who presented to larger VHA hospitals with higher stroke volumes, thus these findings may not be generalizable to smaller VHA hospitals with less systematized stroke care. This sample did not describe the specialty care services that were received by each patient, which may have influenced their stroke care. Finally, this study is an analysis of use of QIs in stroke care and did not examine how these indicators affect outcomes.

Conclusion

Despite reassuring findings for several inpatient ischemic stroke quality metrics, we found several differences in stroke care between patients with IHS compared with those presenting to the ED, emphasizing the need for standardized approaches to stroke care regardless of care setting. Although patients with IHS may be more likely to be eligible for tPA, these patients received dysphagia screening and less often than did ED patients with stroke. Ongoing quality initiatives should continue to place emphasis on improving all quality metrics (particularly dysphagia screening, stroke severity documentation, and stroke education) for patients with stroke at VHA hospitals across all care settings. Future work will be needed to examine how specific patient characteristics and revisions to stroke protocols may affect stroke quality metrics and outcomes between patients with IHS and those presenting to the ED.

Acknowledgments

The authors would like to thank Danielle Sager for her contributions to this project.

The term cataract is derived from the Latin word “catarractes,” which means “waterfall,” as the foamy white opacity of an advanced cataract can be likened to a tempestuous cascade. Cataract is the leading cause of preventable blindness worldwide.^1,2 It is no surprise, therefore, that cataract surgery is the most frequently performed ophthalmic surgical procedure worldwide. Cataract surgeries may reach 30 million annual cases by 2020.³ Given the large number of surgeries being performed, postsurgical complications are not uncommon.

Early postoperative complications from lens exchange (cataract) surgery include increased intraocular pressure (IOP), corneal edema, and corneal wound leakage.⁴ Corneal wound leakage is not uncommon; one study showed that, in 100 cases, almost one-third of incisions leaked.⁵ A 2014 prospective study of 500 postcataract surgery eyes revealed that 48.8% had fluid egress.⁶ Early detection is important so that efforts to restore corneal integrity can immediately be implemented. If not caught early, patients are at risk for developing a cascade of sequelae, including endophthalmitis.

The majority of corneal wound leaks postphacoemulsification are self-limiting and self-sealing. Moderate wound leaks require treatment, as in the following case. Strategies to detect, image, and treat wound leaks are covered in this discussion.

Case Presentation

A 69-year-old male veteran presented with no complaints for a 1-day postoperative visit following right eye phacoemulsification cataract extraction. His best corrected visual acuity in the right eye was 20/40, and his pinhole visual acuity was 20/25+2. On slit-lamp examination, the temporally located main incision appeared well-adhered and was found to be Seidel negative; however, the inferior paracentesis wound was found to be Seidel positive, demonstrating a slow leak. Intraocular pressure (IOP) measured with tonopen was 9 mm Hg.

A bandage soft contact lens was placed on the eye. The patient was instructed not to rub or place any pressure on the eye and to avoid bending and heavy lifting. He was also instructed to continue his postoperative medications (prednisolone 1% every 2 hours and polymyxin B sulfate 4 times daily) in his right eye. A follow-up appointment was scheduled for the next day.

The patient presented for his postoperative day-2 visit with a best corrected visual acuity in the right eye of 20/20. He reported no visual problems, no eye pain, and mentioned that he had had a comfortable night sleep. A slit-lamp examination revealed trace diffuse injection in the operative eye, predominantly central Descemet membrane folds, 1+ stromal edema, and a Seidel negative main incision wound. However, the inferior paracentesis wound showed a moderate leak (Seidel positive), and the anterior chamber showed a 1+ cell and flare. Goldmann tonometry revealed an IOP of 5 mm Hg, indicating hypotony.

Anterior segment cube 512 x 128 optical coherence tomography (OCT) was obtained with the bandage contact lens (Figures 1 and 2), and then repeated with the bandage contact lens removed (Figures 3 and 4). OCT imaging confirmed epithelial and endothelial gaping, loss of coaptation, and a localized detachment of the Descemet membrane. The veteran was referred to his surgeon that same day, and 2 limbal vicryl sutures were placed. The patient was instructed to continue prednisolone 1% 4 times daily and polymyxin B sulfate every 2 hours; erythromycin ointment 3 times daily was added to his regimen.

He was scheduled for a follow-up examination 1 week later. At that visit, the wound was no longer leaking and IOP had risen to a preoperative value of 17 mm Hg. The corneal sutures were removed at the 1-month postoperative examination and a follow-up was scheduled for 4 months later. An anterior segment OCT was obtained (Figure 5).

Discussion

In July 1967, Charles Kelman, MD, suggested using a dental ultrasonic tool, normally employed to clean teeth, to fragment the nucleus of the crystalline lens. Dr. Kelman’s first operation using phacoemulsification on a human eye took 3 hours.⁷ As the procedure for cataract removal has been refined, complication rates and surgical times have vastly improved.

Phacoemulsification is the most commonly performed outpatient surgery in the US; about 3 million cases are performed annually. Due to the high volume of cases, adverse events (AEs) are not uncommon. The incidence of complications following phacoemulsification is < 5%; the frequency of severe complications has been estimated at < 0.7%.⁸ Severe complications include endophthalmitis, suprachoroidal hemorrhage, and/or retinal detachment.⁹ Studies have shown a decline in rates of sight-threatening AEs from 1994 to 2006.⁹ A retrospective study of 45,082 veterans from 2005 to 2007 identified that a preoperative disease burden such as diabetes mellitus, chronic pulmonary disease, age-related macular degeneration, and diabetes with ophthalmic manifestations, was positively associated with a greater risk of cataract surgical complications.¹⁰

Complications

The level of a surgeon’s proficiency with phacoemulsification is directly correlated to the number of operations performed; there is a lower complication rate among more experienced surgeons, including those who work in high-volume settings.^11,12 One study identified that the AE rate within 14 days of surgery was 0.8% for surgeons performing 50 to 250 cataract surgeries per year, but only 0.1% for those performing > 1000 cataract surgeries annually.¹²

Potential postoperative lens exchange complications include increased IOP, corneal wound leakage, corneal edema, bullous keratopathy, cystoid macular edema, retinal detachment, and endophthalmitis (Table 1). A corneal wound leak can provide a potential ingress for bacteria, putting the patient at risk for endophthalmitis, perhaps the most devastating complication following cataract surgery.

Endophthalmitis

Endophthalmitis has been reported to occur in .001% to .327% of patients during postoperative care.^5,13-17 Early detection is important to maintain corneal integrity and prevent a cascade of detrimental ocular sequalae including the potential for endophthalmitis. According to Zaida and colleagues, endophthalmitis occurred in fewer than 1 of 1000 consecutive cases.¹⁴ A leaking clear corneal incision wound on the first day postoperatively has been associated with a 44-fold increased risk of endophthalmitis.¹³

Causes of endophthalmitis

In a retrospective case-controlled series of 57 patients with postcataract endophthalmitis, implantation of an intraocular lens with a resultant wound abnormality was thought to be the causative factor in 5%.¹⁷ Another source of endophthalmitis can be the intraocular lens (IOL), which may act as a vector for bacteria. By placing the IOL against the conjunctiva or exposing it to the theater air during surgery, bacteria can be introduced prior to implantation.¹⁷ Immunosuppressive treatment is the only patient antecedent factor that can be considered a predictor for endopthalmitis.¹⁷

The internal corneal seal is IOP dependent, and postoperative ocular hypotony may cause a seemingly watertight wound to leak. Taban and colleagues used anterior segment OCT to image numerous self-sealing incisions. They found that the corneal incision wound more tightly seals at higher IOPs. Additionally, more perpendicular (larger angle) incisions seal better at a lower IOP while less perpendicular (smaller angle) incisions seal better at a higher IOP (Figure 6).¹⁸

Incision Placement

Studies have shown that the main incision site is more clinically competent than is the side port incision site, as in our case study.¹⁹ Side-port incisions have a 1- or 2-plane architectural profile in contrast to the 3-plane profile typical of a main incision.¹⁹ Recent advances including the conversion to clear-corneal incisions of diminishing size, techniques used for wound construction, phacoemulsification machine design, and small-incision IOLs, should further reduce the prevalence and complications of wound compromise.²⁰

Seidel Testing

Seidel testing is the most common method to evaluate corneal wound integrity and identify leaks. A drop of topical anesthetic is instilled in the eye and then a fluorescein strip (not fluorescein sodium and benoxinate hydrochloride ophthalmic solution, which may become less sterile since it has a multiuse container) is applied to the superior conjunctiva. The clinician then looks for evidence of fluid egress using the cobalt blue filter. The patient is instructed to blink once. Fluid egress appears as a black stream as the fluorescein dye becomes diluted by aqueous humor escaping the nonintact wound and the appearance of bright green dye surrounds the leak site. The term Seidel positive indicates a leak. An estimate should be made of the rate and volume of fluid exiting the wound.

Gonioscopy

Gonioscopy can be used to evaluate the postsurgical incision, more specifically for identification and management of internal incision wound gape. On gonioscopy, internal wound gape appears as an elongated oval opening resembling a fish mouth. If internal incision wound gape is identified gonioscopically before surgery is complete, the leak can be managed intraoperatively. The surgeon can irrigate along the length of the incision to remove cortical fragments or viscoelastic that may cause internal wound gaping. If unsuccessful, rapidly deepening the anterior chamber with balanced salt solution through the paracentesis incision may be employed. These methods may improve wound stability, reduce risk of postoperative hyphema, lower the incidence of endophthalmitis, and lessen the likelihood of late against-the-rule drift.²¹

Anterior Segment Optical Coherence Tomography

Instances when Seidel testing was negative despite actual wound gaping have been described.^22,23 Anterior segment OCT is useful to evaluate incision architecture. A 2007 United Kingdom study investigated the corneal architecture in the immediate postoperative period following phacoemulsification using anterior segment OCT. This study showed the benefits of identifying architectural features such as epithelial gaping, endothelial gaping, stripping of Descemet membrane, and loss of coaptation. These features were found to be more common at low IOP and could represent a significant risk factor for endophthalmitis.²⁴ Another study published by Behrens and colleagues indicated that a localized detachment of Descemet membrane may be more common than observed with slit-lamp (Figure 7). Corneal gaping, especially if along the entire length of the surgical wound, may lead to inadvertent bacterial access into the anterior chamber.²⁵ 

Anterior segment OCT imaging was first described by Izatt and colleagues in 1994.²⁶ Unlike posterior segment OCT, anterior segment OCT requires a greater depth of field and higher energy levels as images are commonly distorted by refraction at boundaries where the refractive index changes. Longer infrared wavelengths improve the penetration through tissues that scatter light, such as the sclera and limbus, which allows visualization, for example, of the iridocorneal angle.^27,28

Two main scan patterns are used for anterior segment OCT: 512 x 128 cube scan (4-mm width x 4-mm length) and 5-line raster (3-mm length) with adjustable rotation and spacing. A recent software update allows measurement of corneal thickness, visualization of anterior chamber angle structures along with topographic analysis, anterior and posterior elevation maps of the cornea, and reliable pachymetric maps.^29,30 The anterior segment cube acquires a series of 128 horizontal scan lines each composed of 512 A-scans. These high-definition scans acquire vertical and horizontal directions composed of 1024 A-scans each. This cube may be used to measure corneal thickness and visualize corneal architecture, creating a 3-D image of the data (Figure 8). The anterior segment 5-line raster scans through 5 parallel lines of equal length to view high-resolution images of the anterior chamber angle and cornea. Each line, fixed at 3-mm in length, is composed of 4096 A-scans.³¹ Anterior segment cube OCT allows identification of subtle variations in incision architecture at different locations across the width of the OCT image.

Bandage Soft Contact Lens

Upon reviewing the anterior segment OCT images of our patient with the bandage contact lens in place, it was evident that the adherent ocular bandage was protecting the incision. A tighter fitting bandage contact lens is ideal and adheres firmly to any area of epithelial damage and epithelial gaping to help seal the incision, protecting the wound and improving structural integrity. The bandage contact lens is gradually replaced by new cells via re-epithelialization; thus, it behaves as an adjunct to natural wound healing. A bandage contact lens also improves patient comfort.

It is hypothesized that a bandage contact lens improves the structural integrity of the incision site and helps prevent leaking, hypotony, and minor wound leaks. One study revealed a statistically significant lower IOP in nonbandage contact lens patients by an average of 6 mm Hg (mean [SD] 13.4 mm Hg [5.3]; range, 5 - 23 mm Hg) vs patients with a bandage contact lens (mean [SD] 19.4 mm Hg [5.9]; range, 11 - 29 mm Hg) in the immediate postoperative period.³² The authors suggested that the bandage contact lens may prevent microleaks, resulting in a higher IOP.

Aqueous Suppressants

Aqueous suppressants are a great option when IOP is abnormally elevated by decreasing the IOP and allowing the cornea to heal and self-seal.Effective aqueous suppressants are β blockers and carbonic anhydrase inhibitors.

After phacoemulsification ocular hypotony (< 6 mm Hg) occurs most commonly due to wound leakage or excessive intraocular inflammation. However, with the presence of corneal wound leakage and ocular hypotony, aqueous suppressants are not the best option.

Further Management of Wound Leaks

Management of a postoperative wound leak will vary based on severity. The majority of mild leaks are self-sealing. Anterior segment OCT helps the clinician to identify microleaks in an otherwise Seidel negative eye. If wound leakage is moderate with a formed anterior chamber, the use of a bandage contact lens is a good option, as can be the prescription of aqueous suppressants, depending on IOP.³³

If the anterior chamber is flat, iris prolapse is apparent, or extremely low IOP exists, the patient needs to be referred to the surgeon. Current standard of care directs the surgeon to use sutures to further manage corneal wound leak. However, several studies have recognized the increased risk of suture-related complications, such as induced astigmatism, corneal opacities, incomplete wound closure, and corneal neovascularization.^6,34-38 Other wound closure options include polyethylene glycol-based products, corneal welding, cyanoacrylate, or fibrin (Table 2).³⁹ Traditionally nylon sutures have been used for clear corneal incision wound closure. However, tissue adhesives are gaining popularity as a substitute for sutures in wound closure.⁴⁰

Cyanoacrylate

Numerous studies have been published on the efficacy of cyanoacrylate as a substitute for sutures, specifically in clear corneal incisions. AEs of cyanoacrylate include a transient foreign-body sensation and diffuse or focal bulbar conjunctival hyperemia.^41,42 Shigemitsu and Majima found that fibrin and cyanoacrylate glue had tensile strength similar to sutures when used in cataract surgery.39 
Polyethylene glycol-based products, also used in artificial tears and contact lens materials, may also help seal wound leaks. Another agent is ReSure (Ocular Therapeutix, Bedford, MA), an FDA-approved synthetic, polyethylene glycol hydrogel sealant that is 90% water after polymerization. ReSure has been shown to be safe and effective in sealing cataract surgical clear corneal incisions.^6,43 ReSure takes about 20 seconds to prepare, and placement is aided by the use of a blue dye that dissipates within hours. This hydrogel will gradually slough off in the tears once the tissue has fully regenerated; there is no need to remove the sealant.⁴⁴

Rossi and colleagues evaluated the efficacy of corneal welding to close wounds after cataract surgery. The technique involves laser-assisted closure of the corneal wound(s) by a diode laser that welds the stroma.⁴⁵ Corneal welding takes seconds to achieve good closure without significant astigmatism or inflammation; however very careful application of the light absorbing dyes is required as they are toxic if allowed to enter the anterior chamber.^45-47

Conclusion

Optometrists may be called to manage patients during both the preoperative and postoperative phases of cataract surgical care. Those who participate in postoperative care should carefully evaluate for the presence of wound leak or wound gape as a potential complication. The OCT may be employed to evaluate patients suspected of having these leaks or gapes. Proficiency in the interpretation of OCT results and more traditional evaluation methods allows for successful detection of wound leaks or gapes. The timely diagnosis and treatment of postoperative wound leaks allow for the best possible outcomes for cataract surgery patients.

The term cataract is derived from the Latin word “catarractes,” which means “waterfall,” as the foamy white opacity of an advanced cataract can be likened to a tempestuous cascade. Cataract is the leading cause of preventable blindness worldwide.^1,2 It is no surprise, therefore, that cataract surgery is the most frequently performed ophthalmic surgical procedure worldwide. Cataract surgeries may reach 30 million annual cases by 2020.³ Given the large number of surgeries being performed, postsurgical complications are not uncommon.

Early postoperative complications from lens exchange (cataract) surgery include increased intraocular pressure (IOP), corneal edema, and corneal wound leakage.⁴ Corneal wound leakage is not uncommon; one study showed that, in 100 cases, almost one-third of incisions leaked.⁵ A 2014 prospective study of 500 postcataract surgery eyes revealed that 48.8% had fluid egress.⁶ Early detection is important so that efforts to restore corneal integrity can immediately be implemented. If not caught early, patients are at risk for developing a cascade of sequelae, including endophthalmitis.

The majority of corneal wound leaks postphacoemulsification are self-limiting and self-sealing. Moderate wound leaks require treatment, as in the following case. Strategies to detect, image, and treat wound leaks are covered in this discussion.

Case Presentation

A 69-year-old male veteran presented with no complaints for a 1-day postoperative visit following right eye phacoemulsification cataract extraction. His best corrected visual acuity in the right eye was 20/40, and his pinhole visual acuity was 20/25+2. On slit-lamp examination, the temporally located main incision appeared well-adhered and was found to be Seidel negative; however, the inferior paracentesis wound was found to be Seidel positive, demonstrating a slow leak. Intraocular pressure (IOP) measured with tonopen was 9 mm Hg.

A bandage soft contact lens was placed on the eye. The patient was instructed not to rub or place any pressure on the eye and to avoid bending and heavy lifting. He was also instructed to continue his postoperative medications (prednisolone 1% every 2 hours and polymyxin B sulfate 4 times daily) in his right eye. A follow-up appointment was scheduled for the next day.

The patient presented for his postoperative day-2 visit with a best corrected visual acuity in the right eye of 20/20. He reported no visual problems, no eye pain, and mentioned that he had had a comfortable night sleep. A slit-lamp examination revealed trace diffuse injection in the operative eye, predominantly central Descemet membrane folds, 1+ stromal edema, and a Seidel negative main incision wound. However, the inferior paracentesis wound showed a moderate leak (Seidel positive), and the anterior chamber showed a 1+ cell and flare. Goldmann tonometry revealed an IOP of 5 mm Hg, indicating hypotony.

Anterior segment cube 512 x 128 optical coherence tomography (OCT) was obtained with the bandage contact lens (Figures 1 and 2), and then repeated with the bandage contact lens removed (Figures 3 and 4). OCT imaging confirmed epithelial and endothelial gaping, loss of coaptation, and a localized detachment of the Descemet membrane. The veteran was referred to his surgeon that same day, and 2 limbal vicryl sutures were placed. The patient was instructed to continue prednisolone 1% 4 times daily and polymyxin B sulfate every 2 hours; erythromycin ointment 3 times daily was added to his regimen.

He was scheduled for a follow-up examination 1 week later. At that visit, the wound was no longer leaking and IOP had risen to a preoperative value of 17 mm Hg. The corneal sutures were removed at the 1-month postoperative examination and a follow-up was scheduled for 4 months later. An anterior segment OCT was obtained (Figure 5).

Discussion

In July 1967, Charles Kelman, MD, suggested using a dental ultrasonic tool, normally employed to clean teeth, to fragment the nucleus of the crystalline lens. Dr. Kelman’s first operation using phacoemulsification on a human eye took 3 hours.⁷ As the procedure for cataract removal has been refined, complication rates and surgical times have vastly improved.

Phacoemulsification is the most commonly performed outpatient surgery in the US; about 3 million cases are performed annually. Due to the high volume of cases, adverse events (AEs) are not uncommon. The incidence of complications following phacoemulsification is < 5%; the frequency of severe complications has been estimated at < 0.7%.⁸ Severe complications include endophthalmitis, suprachoroidal hemorrhage, and/or retinal detachment.⁹ Studies have shown a decline in rates of sight-threatening AEs from 1994 to 2006.⁹ A retrospective study of 45,082 veterans from 2005 to 2007 identified that a preoperative disease burden such as diabetes mellitus, chronic pulmonary disease, age-related macular degeneration, and diabetes with ophthalmic manifestations, was positively associated with a greater risk of cataract surgical complications.¹⁰

Complications

The level of a surgeon’s proficiency with phacoemulsification is directly correlated to the number of operations performed; there is a lower complication rate among more experienced surgeons, including those who work in high-volume settings.^11,12 One study identified that the AE rate within 14 days of surgery was 0.8% for surgeons performing 50 to 250 cataract surgeries per year, but only 0.1% for those performing > 1000 cataract surgeries annually.¹²

Potential postoperative lens exchange complications include increased IOP, corneal wound leakage, corneal edema, bullous keratopathy, cystoid macular edema, retinal detachment, and endophthalmitis (Table 1). A corneal wound leak can provide a potential ingress for bacteria, putting the patient at risk for endophthalmitis, perhaps the most devastating complication following cataract surgery.

Endophthalmitis

Endophthalmitis has been reported to occur in .001% to .327% of patients during postoperative care.^5,13-17 Early detection is important to maintain corneal integrity and prevent a cascade of detrimental ocular sequalae including the potential for endophthalmitis. According to Zaida and colleagues, endophthalmitis occurred in fewer than 1 of 1000 consecutive cases.¹⁴ A leaking clear corneal incision wound on the first day postoperatively has been associated with a 44-fold increased risk of endophthalmitis.¹³

Causes of endophthalmitis

In a retrospective case-controlled series of 57 patients with postcataract endophthalmitis, implantation of an intraocular lens with a resultant wound abnormality was thought to be the causative factor in 5%.¹⁷ Another source of endophthalmitis can be the intraocular lens (IOL), which may act as a vector for bacteria. By placing the IOL against the conjunctiva or exposing it to the theater air during surgery, bacteria can be introduced prior to implantation.¹⁷ Immunosuppressive treatment is the only patient antecedent factor that can be considered a predictor for endopthalmitis.¹⁷

The internal corneal seal is IOP dependent, and postoperative ocular hypotony may cause a seemingly watertight wound to leak. Taban and colleagues used anterior segment OCT to image numerous self-sealing incisions. They found that the corneal incision wound more tightly seals at higher IOPs. Additionally, more perpendicular (larger angle) incisions seal better at a lower IOP while less perpendicular (smaller angle) incisions seal better at a higher IOP (Figure 6).¹⁸

Incision Placement

Studies have shown that the main incision site is more clinically competent than is the side port incision site, as in our case study.¹⁹ Side-port incisions have a 1- or 2-plane architectural profile in contrast to the 3-plane profile typical of a main incision.¹⁹ Recent advances including the conversion to clear-corneal incisions of diminishing size, techniques used for wound construction, phacoemulsification machine design, and small-incision IOLs, should further reduce the prevalence and complications of wound compromise.²⁰

Seidel Testing

Seidel testing is the most common method to evaluate corneal wound integrity and identify leaks. A drop of topical anesthetic is instilled in the eye and then a fluorescein strip (not fluorescein sodium and benoxinate hydrochloride ophthalmic solution, which may become less sterile since it has a multiuse container) is applied to the superior conjunctiva. The clinician then looks for evidence of fluid egress using the cobalt blue filter. The patient is instructed to blink once. Fluid egress appears as a black stream as the fluorescein dye becomes diluted by aqueous humor escaping the nonintact wound and the appearance of bright green dye surrounds the leak site. The term Seidel positive indicates a leak. An estimate should be made of the rate and volume of fluid exiting the wound.

Gonioscopy

Gonioscopy can be used to evaluate the postsurgical incision, more specifically for identification and management of internal incision wound gape. On gonioscopy, internal wound gape appears as an elongated oval opening resembling a fish mouth. If internal incision wound gape is identified gonioscopically before surgery is complete, the leak can be managed intraoperatively. The surgeon can irrigate along the length of the incision to remove cortical fragments or viscoelastic that may cause internal wound gaping. If unsuccessful, rapidly deepening the anterior chamber with balanced salt solution through the paracentesis incision may be employed. These methods may improve wound stability, reduce risk of postoperative hyphema, lower the incidence of endophthalmitis, and lessen the likelihood of late against-the-rule drift.²¹

Anterior Segment Optical Coherence Tomography

Instances when Seidel testing was negative despite actual wound gaping have been described.^22,23 Anterior segment OCT is useful to evaluate incision architecture. A 2007 United Kingdom study investigated the corneal architecture in the immediate postoperative period following phacoemulsification using anterior segment OCT. This study showed the benefits of identifying architectural features such as epithelial gaping, endothelial gaping, stripping of Descemet membrane, and loss of coaptation. These features were found to be more common at low IOP and could represent a significant risk factor for endophthalmitis.²⁴ Another study published by Behrens and colleagues indicated that a localized detachment of Descemet membrane may be more common than observed with slit-lamp (Figure 7). Corneal gaping, especially if along the entire length of the surgical wound, may lead to inadvertent bacterial access into the anterior chamber.²⁵ 

Anterior segment OCT imaging was first described by Izatt and colleagues in 1994.²⁶ Unlike posterior segment OCT, anterior segment OCT requires a greater depth of field and higher energy levels as images are commonly distorted by refraction at boundaries where the refractive index changes. Longer infrared wavelengths improve the penetration through tissues that scatter light, such as the sclera and limbus, which allows visualization, for example, of the iridocorneal angle.^27,28

Two main scan patterns are used for anterior segment OCT: 512 x 128 cube scan (4-mm width x 4-mm length) and 5-line raster (3-mm length) with adjustable rotation and spacing. A recent software update allows measurement of corneal thickness, visualization of anterior chamber angle structures along with topographic analysis, anterior and posterior elevation maps of the cornea, and reliable pachymetric maps.^29,30 The anterior segment cube acquires a series of 128 horizontal scan lines each composed of 512 A-scans. These high-definition scans acquire vertical and horizontal directions composed of 1024 A-scans each. This cube may be used to measure corneal thickness and visualize corneal architecture, creating a 3-D image of the data (Figure 8). The anterior segment 5-line raster scans through 5 parallel lines of equal length to view high-resolution images of the anterior chamber angle and cornea. Each line, fixed at 3-mm in length, is composed of 4096 A-scans.³¹ Anterior segment cube OCT allows identification of subtle variations in incision architecture at different locations across the width of the OCT image.

Bandage Soft Contact Lens

Upon reviewing the anterior segment OCT images of our patient with the bandage contact lens in place, it was evident that the adherent ocular bandage was protecting the incision. A tighter fitting bandage contact lens is ideal and adheres firmly to any area of epithelial damage and epithelial gaping to help seal the incision, protecting the wound and improving structural integrity. The bandage contact lens is gradually replaced by new cells via re-epithelialization; thus, it behaves as an adjunct to natural wound healing. A bandage contact lens also improves patient comfort.

It is hypothesized that a bandage contact lens improves the structural integrity of the incision site and helps prevent leaking, hypotony, and minor wound leaks. One study revealed a statistically significant lower IOP in nonbandage contact lens patients by an average of 6 mm Hg (mean [SD] 13.4 mm Hg [5.3]; range, 5 - 23 mm Hg) vs patients with a bandage contact lens (mean [SD] 19.4 mm Hg [5.9]; range, 11 - 29 mm Hg) in the immediate postoperative period.³² The authors suggested that the bandage contact lens may prevent microleaks, resulting in a higher IOP.

Aqueous Suppressants

Aqueous suppressants are a great option when IOP is abnormally elevated by decreasing the IOP and allowing the cornea to heal and self-seal.Effective aqueous suppressants are β blockers and carbonic anhydrase inhibitors.

After phacoemulsification ocular hypotony (< 6 mm Hg) occurs most commonly due to wound leakage or excessive intraocular inflammation. However, with the presence of corneal wound leakage and ocular hypotony, aqueous suppressants are not the best option.

Further Management of Wound Leaks

Management of a postoperative wound leak will vary based on severity. The majority of mild leaks are self-sealing. Anterior segment OCT helps the clinician to identify microleaks in an otherwise Seidel negative eye. If wound leakage is moderate with a formed anterior chamber, the use of a bandage contact lens is a good option, as can be the prescription of aqueous suppressants, depending on IOP.³³

If the anterior chamber is flat, iris prolapse is apparent, or extremely low IOP exists, the patient needs to be referred to the surgeon. Current standard of care directs the surgeon to use sutures to further manage corneal wound leak. However, several studies have recognized the increased risk of suture-related complications, such as induced astigmatism, corneal opacities, incomplete wound closure, and corneal neovascularization.^6,34-38 Other wound closure options include polyethylene glycol-based products, corneal welding, cyanoacrylate, or fibrin (Table 2).³⁹ Traditionally nylon sutures have been used for clear corneal incision wound closure. However, tissue adhesives are gaining popularity as a substitute for sutures in wound closure.⁴⁰

Cyanoacrylate

Numerous studies have been published on the efficacy of cyanoacrylate as a substitute for sutures, specifically in clear corneal incisions. AEs of cyanoacrylate include a transient foreign-body sensation and diffuse or focal bulbar conjunctival hyperemia.^41,42 Shigemitsu and Majima found that fibrin and cyanoacrylate glue had tensile strength similar to sutures when used in cataract surgery.39 
Polyethylene glycol-based products, also used in artificial tears and contact lens materials, may also help seal wound leaks. Another agent is ReSure (Ocular Therapeutix, Bedford, MA), an FDA-approved synthetic, polyethylene glycol hydrogel sealant that is 90% water after polymerization. ReSure has been shown to be safe and effective in sealing cataract surgical clear corneal incisions.^6,43 ReSure takes about 20 seconds to prepare, and placement is aided by the use of a blue dye that dissipates within hours. This hydrogel will gradually slough off in the tears once the tissue has fully regenerated; there is no need to remove the sealant.⁴⁴

Rossi and colleagues evaluated the efficacy of corneal welding to close wounds after cataract surgery. The technique involves laser-assisted closure of the corneal wound(s) by a diode laser that welds the stroma.⁴⁵ Corneal welding takes seconds to achieve good closure without significant astigmatism or inflammation; however very careful application of the light absorbing dyes is required as they are toxic if allowed to enter the anterior chamber.^45-47

Conclusion

Optometrists may be called to manage patients during both the preoperative and postoperative phases of cataract surgical care. Those who participate in postoperative care should carefully evaluate for the presence of wound leak or wound gape as a potential complication. The OCT may be employed to evaluate patients suspected of having these leaks or gapes. Proficiency in the interpretation of OCT results and more traditional evaluation methods allows for successful detection of wound leaks or gapes. The timely diagnosis and treatment of postoperative wound leaks allow for the best possible outcomes for cataract surgery patients.

The term cataract is derived from the Latin word “catarractes,” which means “waterfall,” as the foamy white opacity of an advanced cataract can be likened to a tempestuous cascade. Cataract is the leading cause of preventable blindness worldwide.^1,2 It is no surprise, therefore, that cataract surgery is the most frequently performed ophthalmic surgical procedure worldwide. Cataract surgeries may reach 30 million annual cases by 2020.³ Given the large number of surgeries being performed, postsurgical complications are not uncommon.

Early postoperative complications from lens exchange (cataract) surgery include increased intraocular pressure (IOP), corneal edema, and corneal wound leakage.⁴ Corneal wound leakage is not uncommon; one study showed that, in 100 cases, almost one-third of incisions leaked.⁵ A 2014 prospective study of 500 postcataract surgery eyes revealed that 48.8% had fluid egress.⁶ Early detection is important so that efforts to restore corneal integrity can immediately be implemented. If not caught early, patients are at risk for developing a cascade of sequelae, including endophthalmitis.

The majority of corneal wound leaks postphacoemulsification are self-limiting and self-sealing. Moderate wound leaks require treatment, as in the following case. Strategies to detect, image, and treat wound leaks are covered in this discussion.

Case Presentation

A 69-year-old male veteran presented with no complaints for a 1-day postoperative visit following right eye phacoemulsification cataract extraction. His best corrected visual acuity in the right eye was 20/40, and his pinhole visual acuity was 20/25+2. On slit-lamp examination, the temporally located main incision appeared well-adhered and was found to be Seidel negative; however, the inferior paracentesis wound was found to be Seidel positive, demonstrating a slow leak. Intraocular pressure (IOP) measured with tonopen was 9 mm Hg.

A bandage soft contact lens was placed on the eye. The patient was instructed not to rub or place any pressure on the eye and to avoid bending and heavy lifting. He was also instructed to continue his postoperative medications (prednisolone 1% every 2 hours and polymyxin B sulfate 4 times daily) in his right eye. A follow-up appointment was scheduled for the next day.

The patient presented for his postoperative day-2 visit with a best corrected visual acuity in the right eye of 20/20. He reported no visual problems, no eye pain, and mentioned that he had had a comfortable night sleep. A slit-lamp examination revealed trace diffuse injection in the operative eye, predominantly central Descemet membrane folds, 1+ stromal edema, and a Seidel negative main incision wound. However, the inferior paracentesis wound showed a moderate leak (Seidel positive), and the anterior chamber showed a 1+ cell and flare. Goldmann tonometry revealed an IOP of 5 mm Hg, indicating hypotony.

Anterior segment cube 512 x 128 optical coherence tomography (OCT) was obtained with the bandage contact lens (Figures 1 and 2), and then repeated with the bandage contact lens removed (Figures 3 and 4). OCT imaging confirmed epithelial and endothelial gaping, loss of coaptation, and a localized detachment of the Descemet membrane. The veteran was referred to his surgeon that same day, and 2 limbal vicryl sutures were placed. The patient was instructed to continue prednisolone 1% 4 times daily and polymyxin B sulfate every 2 hours; erythromycin ointment 3 times daily was added to his regimen.

He was scheduled for a follow-up examination 1 week later. At that visit, the wound was no longer leaking and IOP had risen to a preoperative value of 17 mm Hg. The corneal sutures were removed at the 1-month postoperative examination and a follow-up was scheduled for 4 months later. An anterior segment OCT was obtained (Figure 5).

Discussion

In July 1967, Charles Kelman, MD, suggested using a dental ultrasonic tool, normally employed to clean teeth, to fragment the nucleus of the crystalline lens. Dr. Kelman’s first operation using phacoemulsification on a human eye took 3 hours.⁷ As the procedure for cataract removal has been refined, complication rates and surgical times have vastly improved.

Phacoemulsification is the most commonly performed outpatient surgery in the US; about 3 million cases are performed annually. Due to the high volume of cases, adverse events (AEs) are not uncommon. The incidence of complications following phacoemulsification is < 5%; the frequency of severe complications has been estimated at < 0.7%.⁸ Severe complications include endophthalmitis, suprachoroidal hemorrhage, and/or retinal detachment.⁹ Studies have shown a decline in rates of sight-threatening AEs from 1994 to 2006.⁹ A retrospective study of 45,082 veterans from 2005 to 2007 identified that a preoperative disease burden such as diabetes mellitus, chronic pulmonary disease, age-related macular degeneration, and diabetes with ophthalmic manifestations, was positively associated with a greater risk of cataract surgical complications.¹⁰

Complications

The level of a surgeon’s proficiency with phacoemulsification is directly correlated to the number of operations performed; there is a lower complication rate among more experienced surgeons, including those who work in high-volume settings.^11,12 One study identified that the AE rate within 14 days of surgery was 0.8% for surgeons performing 50 to 250 cataract surgeries per year, but only 0.1% for those performing > 1000 cataract surgeries annually.¹²

Potential postoperative lens exchange complications include increased IOP, corneal wound leakage, corneal edema, bullous keratopathy, cystoid macular edema, retinal detachment, and endophthalmitis (Table 1). A corneal wound leak can provide a potential ingress for bacteria, putting the patient at risk for endophthalmitis, perhaps the most devastating complication following cataract surgery.

Endophthalmitis

Endophthalmitis has been reported to occur in .001% to .327% of patients during postoperative care.^5,13-17 Early detection is important to maintain corneal integrity and prevent a cascade of detrimental ocular sequalae including the potential for endophthalmitis. According to Zaida and colleagues, endophthalmitis occurred in fewer than 1 of 1000 consecutive cases.¹⁴ A leaking clear corneal incision wound on the first day postoperatively has been associated with a 44-fold increased risk of endophthalmitis.¹³

Causes of endophthalmitis

In a retrospective case-controlled series of 57 patients with postcataract endophthalmitis, implantation of an intraocular lens with a resultant wound abnormality was thought to be the causative factor in 5%.¹⁷ Another source of endophthalmitis can be the intraocular lens (IOL), which may act as a vector for bacteria. By placing the IOL against the conjunctiva or exposing it to the theater air during surgery, bacteria can be introduced prior to implantation.¹⁷ Immunosuppressive treatment is the only patient antecedent factor that can be considered a predictor for endopthalmitis.¹⁷

The internal corneal seal is IOP dependent, and postoperative ocular hypotony may cause a seemingly watertight wound to leak. Taban and colleagues used anterior segment OCT to image numerous self-sealing incisions. They found that the corneal incision wound more tightly seals at higher IOPs. Additionally, more perpendicular (larger angle) incisions seal better at a lower IOP while less perpendicular (smaller angle) incisions seal better at a higher IOP (Figure 6).¹⁸

Incision Placement

Studies have shown that the main incision site is more clinically competent than is the side port incision site, as in our case study.¹⁹ Side-port incisions have a 1- or 2-plane architectural profile in contrast to the 3-plane profile typical of a main incision.¹⁹ Recent advances including the conversion to clear-corneal incisions of diminishing size, techniques used for wound construction, phacoemulsification machine design, and small-incision IOLs, should further reduce the prevalence and complications of wound compromise.²⁰

Seidel Testing

Seidel testing is the most common method to evaluate corneal wound integrity and identify leaks. A drop of topical anesthetic is instilled in the eye and then a fluorescein strip (not fluorescein sodium and benoxinate hydrochloride ophthalmic solution, which may become less sterile since it has a multiuse container) is applied to the superior conjunctiva. The clinician then looks for evidence of fluid egress using the cobalt blue filter. The patient is instructed to blink once. Fluid egress appears as a black stream as the fluorescein dye becomes diluted by aqueous humor escaping the nonintact wound and the appearance of bright green dye surrounds the leak site. The term Seidel positive indicates a leak. An estimate should be made of the rate and volume of fluid exiting the wound.

Gonioscopy

Gonioscopy can be used to evaluate the postsurgical incision, more specifically for identification and management of internal incision wound gape. On gonioscopy, internal wound gape appears as an elongated oval opening resembling a fish mouth. If internal incision wound gape is identified gonioscopically before surgery is complete, the leak can be managed intraoperatively. The surgeon can irrigate along the length of the incision to remove cortical fragments or viscoelastic that may cause internal wound gaping. If unsuccessful, rapidly deepening the anterior chamber with balanced salt solution through the paracentesis incision may be employed. These methods may improve wound stability, reduce risk of postoperative hyphema, lower the incidence of endophthalmitis, and lessen the likelihood of late against-the-rule drift.²¹

Anterior Segment Optical Coherence Tomography

Instances when Seidel testing was negative despite actual wound gaping have been described.^22,23 Anterior segment OCT is useful to evaluate incision architecture. A 2007 United Kingdom study investigated the corneal architecture in the immediate postoperative period following phacoemulsification using anterior segment OCT. This study showed the benefits of identifying architectural features such as epithelial gaping, endothelial gaping, stripping of Descemet membrane, and loss of coaptation. These features were found to be more common at low IOP and could represent a significant risk factor for endophthalmitis.²⁴ Another study published by Behrens and colleagues indicated that a localized detachment of Descemet membrane may be more common than observed with slit-lamp (Figure 7). Corneal gaping, especially if along the entire length of the surgical wound, may lead to inadvertent bacterial access into the anterior chamber.²⁵ 

Anterior segment OCT imaging was first described by Izatt and colleagues in 1994.²⁶ Unlike posterior segment OCT, anterior segment OCT requires a greater depth of field and higher energy levels as images are commonly distorted by refraction at boundaries where the refractive index changes. Longer infrared wavelengths improve the penetration through tissues that scatter light, such as the sclera and limbus, which allows visualization, for example, of the iridocorneal angle.^27,28

Two main scan patterns are used for anterior segment OCT: 512 x 128 cube scan (4-mm width x 4-mm length) and 5-line raster (3-mm length) with adjustable rotation and spacing. A recent software update allows measurement of corneal thickness, visualization of anterior chamber angle structures along with topographic analysis, anterior and posterior elevation maps of the cornea, and reliable pachymetric maps.^29,30 The anterior segment cube acquires a series of 128 horizontal scan lines each composed of 512 A-scans. These high-definition scans acquire vertical and horizontal directions composed of 1024 A-scans each. This cube may be used to measure corneal thickness and visualize corneal architecture, creating a 3-D image of the data (Figure 8). The anterior segment 5-line raster scans through 5 parallel lines of equal length to view high-resolution images of the anterior chamber angle and cornea. Each line, fixed at 3-mm in length, is composed of 4096 A-scans.³¹ Anterior segment cube OCT allows identification of subtle variations in incision architecture at different locations across the width of the OCT image.

Bandage Soft Contact Lens

Upon reviewing the anterior segment OCT images of our patient with the bandage contact lens in place, it was evident that the adherent ocular bandage was protecting the incision. A tighter fitting bandage contact lens is ideal and adheres firmly to any area of epithelial damage and epithelial gaping to help seal the incision, protecting the wound and improving structural integrity. The bandage contact lens is gradually replaced by new cells via re-epithelialization; thus, it behaves as an adjunct to natural wound healing. A bandage contact lens also improves patient comfort.

It is hypothesized that a bandage contact lens improves the structural integrity of the incision site and helps prevent leaking, hypotony, and minor wound leaks. One study revealed a statistically significant lower IOP in nonbandage contact lens patients by an average of 6 mm Hg (mean [SD] 13.4 mm Hg [5.3]; range, 5 - 23 mm Hg) vs patients with a bandage contact lens (mean [SD] 19.4 mm Hg [5.9]; range, 11 - 29 mm Hg) in the immediate postoperative period.³² The authors suggested that the bandage contact lens may prevent microleaks, resulting in a higher IOP.

Aqueous Suppressants

Aqueous suppressants are a great option when IOP is abnormally elevated by decreasing the IOP and allowing the cornea to heal and self-seal.Effective aqueous suppressants are β blockers and carbonic anhydrase inhibitors.

After phacoemulsification ocular hypotony (< 6 mm Hg) occurs most commonly due to wound leakage or excessive intraocular inflammation. However, with the presence of corneal wound leakage and ocular hypotony, aqueous suppressants are not the best option.

Further Management of Wound Leaks

Management of a postoperative wound leak will vary based on severity. The majority of mild leaks are self-sealing. Anterior segment OCT helps the clinician to identify microleaks in an otherwise Seidel negative eye. If wound leakage is moderate with a formed anterior chamber, the use of a bandage contact lens is a good option, as can be the prescription of aqueous suppressants, depending on IOP.³³

If the anterior chamber is flat, iris prolapse is apparent, or extremely low IOP exists, the patient needs to be referred to the surgeon. Current standard of care directs the surgeon to use sutures to further manage corneal wound leak. However, several studies have recognized the increased risk of suture-related complications, such as induced astigmatism, corneal opacities, incomplete wound closure, and corneal neovascularization.^6,34-38 Other wound closure options include polyethylene glycol-based products, corneal welding, cyanoacrylate, or fibrin (Table 2).³⁹ Traditionally nylon sutures have been used for clear corneal incision wound closure. However, tissue adhesives are gaining popularity as a substitute for sutures in wound closure.⁴⁰

Cyanoacrylate

Numerous studies have been published on the efficacy of cyanoacrylate as a substitute for sutures, specifically in clear corneal incisions. AEs of cyanoacrylate include a transient foreign-body sensation and diffuse or focal bulbar conjunctival hyperemia.^41,42 Shigemitsu and Majima found that fibrin and cyanoacrylate glue had tensile strength similar to sutures when used in cataract surgery.39 
Polyethylene glycol-based products, also used in artificial tears and contact lens materials, may also help seal wound leaks. Another agent is ReSure (Ocular Therapeutix, Bedford, MA), an FDA-approved synthetic, polyethylene glycol hydrogel sealant that is 90% water after polymerization. ReSure has been shown to be safe and effective in sealing cataract surgical clear corneal incisions.^6,43 ReSure takes about 20 seconds to prepare, and placement is aided by the use of a blue dye that dissipates within hours. This hydrogel will gradually slough off in the tears once the tissue has fully regenerated; there is no need to remove the sealant.⁴⁴

Rossi and colleagues evaluated the efficacy of corneal welding to close wounds after cataract surgery. The technique involves laser-assisted closure of the corneal wound(s) by a diode laser that welds the stroma.⁴⁵ Corneal welding takes seconds to achieve good closure without significant astigmatism or inflammation; however very careful application of the light absorbing dyes is required as they are toxic if allowed to enter the anterior chamber.^45-47

Conclusion

Optometrists may be called to manage patients during both the preoperative and postoperative phases of cataract surgical care. Those who participate in postoperative care should carefully evaluate for the presence of wound leak or wound gape as a potential complication. The OCT may be employed to evaluate patients suspected of having these leaks or gapes. Proficiency in the interpretation of OCT results and more traditional evaluation methods allows for successful detection of wound leaks or gapes. The timely diagnosis and treatment of postoperative wound leaks allow for the best possible outcomes for cataract surgery patients.

The U.S. Preventive Services Task Force has issued a recommendation statement reaffirming its 2004 guideline, which recommended against screening for pancreatic cancer in asymptomatic adults, according to task force member Douglas K. Owens, MD, of the Veterans Affairs Palo Alto (Calif.) Health Care System and associates.

Pancreatic cancer is uncommon, with an age-adjusted annual incidence of 12.9 cases per 100,000 person-years; however, pancreatic cancer is the third most common cause of cancer death because mortality is high. The mortality rate is 11.0 deaths per 100,000 person-years, and an estimated 45,750 people will die from the disease in 2019.

In 2004, the USPSTF issued a D recommendation for pancreatic cancer screening in asymptomatic adults without a family history of pancreatic cancer or a genetic disorder that increases the risk of cancer. For the 2019 update, the task force conducted a systematic review of 13 studies that assessed the benefits and harms of screening for pancreatic cancer, the diagnostic accuracy of screening tests for pancreatic cancer, and the benefits and harms of treating screen-detected or asymptomatic pancreatic cancer.

According to the USPSTF, the studies included in the review found no evidence that screening for pancreatic cancer or treatment of screen-detected pancreatic cancer improves morbidity or mortality, found adequate evidence that the magnitude of the benefits of screening for pancreatic cancer in asymptomatic adults can be bounded as no greater than small, and found adequate evidence that the magnitude of the harms of screening for pancreatic cancer and treatment of screen-detected pancreatic cancer can be bounded as at least moderate.

Because no new evidence was found supporting pancreatic cancer screening in asymptomatic adults, “the USPSTF reaffirms its previous conclusion that the potential benefits of screening for pancreatic cancer in asymptomatic adults do not outweigh the potential harms,” the task force members noted.

The task force authors reported no disclosures related to the recommendation statement.

SOURCE: Owens DK et al. JAMA. 2019 Aug 6. doi: 10.1001/jama.2019.10232.

The U.S. Preventive Services Task Force has issued a recommendation statement reaffirming its 2004 guideline, which recommended against screening for pancreatic cancer in asymptomatic adults, according to task force member Douglas K. Owens, MD, of the Veterans Affairs Palo Alto (Calif.) Health Care System and associates.

Pancreatic cancer is uncommon, with an age-adjusted annual incidence of 12.9 cases per 100,000 person-years; however, pancreatic cancer is the third most common cause of cancer death because mortality is high. The mortality rate is 11.0 deaths per 100,000 person-years, and an estimated 45,750 people will die from the disease in 2019.

In 2004, the USPSTF issued a D recommendation for pancreatic cancer screening in asymptomatic adults without a family history of pancreatic cancer or a genetic disorder that increases the risk of cancer. For the 2019 update, the task force conducted a systematic review of 13 studies that assessed the benefits and harms of screening for pancreatic cancer, the diagnostic accuracy of screening tests for pancreatic cancer, and the benefits and harms of treating screen-detected or asymptomatic pancreatic cancer.

According to the USPSTF, the studies included in the review found no evidence that screening for pancreatic cancer or treatment of screen-detected pancreatic cancer improves morbidity or mortality, found adequate evidence that the magnitude of the benefits of screening for pancreatic cancer in asymptomatic adults can be bounded as no greater than small, and found adequate evidence that the magnitude of the harms of screening for pancreatic cancer and treatment of screen-detected pancreatic cancer can be bounded as at least moderate.

Because no new evidence was found supporting pancreatic cancer screening in asymptomatic adults, “the USPSTF reaffirms its previous conclusion that the potential benefits of screening for pancreatic cancer in asymptomatic adults do not outweigh the potential harms,” the task force members noted.

The task force authors reported no disclosures related to the recommendation statement.

SOURCE: Owens DK et al. JAMA. 2019 Aug 6. doi: 10.1001/jama.2019.10232.

The U.S. Preventive Services Task Force has issued a recommendation statement reaffirming its 2004 guideline, which recommended against screening for pancreatic cancer in asymptomatic adults, according to task force member Douglas K. Owens, MD, of the Veterans Affairs Palo Alto (Calif.) Health Care System and associates.

Pancreatic cancer is uncommon, with an age-adjusted annual incidence of 12.9 cases per 100,000 person-years; however, pancreatic cancer is the third most common cause of cancer death because mortality is high. The mortality rate is 11.0 deaths per 100,000 person-years, and an estimated 45,750 people will die from the disease in 2019.

In 2004, the USPSTF issued a D recommendation for pancreatic cancer screening in asymptomatic adults without a family history of pancreatic cancer or a genetic disorder that increases the risk of cancer. For the 2019 update, the task force conducted a systematic review of 13 studies that assessed the benefits and harms of screening for pancreatic cancer, the diagnostic accuracy of screening tests for pancreatic cancer, and the benefits and harms of treating screen-detected or asymptomatic pancreatic cancer.

According to the USPSTF, the studies included in the review found no evidence that screening for pancreatic cancer or treatment of screen-detected pancreatic cancer improves morbidity or mortality, found adequate evidence that the magnitude of the benefits of screening for pancreatic cancer in asymptomatic adults can be bounded as no greater than small, and found adequate evidence that the magnitude of the harms of screening for pancreatic cancer and treatment of screen-detected pancreatic cancer can be bounded as at least moderate.

Because no new evidence was found supporting pancreatic cancer screening in asymptomatic adults, “the USPSTF reaffirms its previous conclusion that the potential benefits of screening for pancreatic cancer in asymptomatic adults do not outweigh the potential harms,” the task force members noted.

The task force authors reported no disclosures related to the recommendation statement.

SOURCE: Owens DK et al. JAMA. 2019 Aug 6. doi: 10.1001/jama.2019.10232.