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Hospitalists' Challenge and Opportunity
Can you explain why Dr. Johnson thinks I should be taking antibiotics, while your note says I shouldn't?
Today you may be surprised by such an inquiry during morning rounds, but such questions are likely coming to your wards. At a time of societal fascination both with transparency and the explosion of health information technologies, a growing number of hospitals are offering, or will soon offer, patients and their family instantaneous access to their doctors' and nurses' notes. What will this new opportunity for patient engagement mean for the hospitalist?
BACKGROUND
Helping patients through highly complicated care processes is no easy feat, and enabling patients and their families to deal successfully with a constantly changing scenario is a particular challenge for hospitalists. Multiple studies show how poorly patients recall information offered them in office visits,[1, 2] and such settings are far less stressful than the rapid fire mixture of procedures, multiple medications, and morbid disease processes that take center stage in so many hospitalizations. And now something new: What is in store for patients and their doctors when patients in a hospital room gain access in real time not only to test results, but also to notes written by their hospitalists, nurses, and consultants?
ENGAGING PATIENTS
With the principal goal of promoting more active patient engagement in care, patient portals designed primarily for ambulatory practice are proliferating rapidly. Not only do they offer patients windows into their records and secure ways to communicate with their providers, their goal is also to automate chores such as reporting results or other administrative tasks that take away from valuable face‐to‐face time between providers and patients. First appearing shortly after the dawn of the Internet, secure electronic portals began to offer patients access to much of their chart.[3] Rapidly evolving beyond limited data feeds over very simple connections, portals today share far more data, are spreading rapidly, and in some cases offer patients access to their entire records. Whether or not 1 record can serve all the traditional users and also the patient and family is a fascinating question,[4] but the fact is that patients can now access their records from their computers, and via smartphones and tablets on the go. While lying in hospital beds, they can gain access to their laboratory and test data as the data evolve, and sometimes the patients see the findings well before their busy clinicians. Moreover, family members, other informal caregivers, or a formally designated health care proxy, will access the patient's record as well, whether through documented proxy functions or by informally peering at the patient's tablet.
MEANINGFUL USE INCENTIVES
Today, state and federal government regulations either encourage or require healthcare providers to grant patients access to their clinical information. But despite the rules embedded in the federal Health Insurance Portability and Accountability Act, patients often face time‐consuming obstacles in their quest for access, and many providers view compliance as a burden. We suggest an alternative view. Over time, we anticipate that inviting patients to review their medical record will reduce risk, increase knowledge, foster active engagement, and help them take more control of their care.
With the goal also of reducing medical errors and improving outcomes, the expansion of portals is accompanied by a combination of incentives, and in the future, sanctions, as the Center for Medicare and Medicaid Services (CMS) refines efforts to promote certified electronic health record technologies that focus on meaningful use (MU), which often include patient engagement tools such as portals. In the fall of 2012, CMS announced stage 2 MU objectives, with several having substantial implications for hospitalists and their patients. One calls for providing patients the ability to view online, download and transmit their health information within 4 business days of the information being available to the provider. Rather than an outpatient‐only requirement, it is a practice‐based requirement, and we can soon expect hospitalist data to appear on portals.
INSIGHTS FROM TRANSPARENCY IN PRIMARY CARE
The OpenNotes trial provides clues as to how such practice will affect both patients and providers.[5, 6] The trial included patients and primary care physicians (PCPs) from 3 diverse settings: Beth Israel Deaconess Medical Center (BIDMC), an urban academic health center in Boston, Massachusetts, and affiliated community practices near Boston; Geisinger Health System, a primarily rural integrated health system in Pennsylvania; and adult medicine and human immunodeficiency virus clinics at Harborview Medical Center, a safety net hospital in Seattle, Washington. More than 100 volunteering PCPs invited 20,000 of their patients enrolled in their institution's portals to read their office visit notes over a 1‐year period. Physicianpatient messaging was tracked to examine impact on physician workloads, and patients and physicians were surveyed before and after the intervention.
The experience generated considerable enthusiasm and potential clinical benefits among the patients, with little adverse impact on patients and providers. Of particular relevance for hospitalists, more than 4 in 5 patients read their notes, with more than 70% reporting they understood their medical conditions better and felt more in control of their care, and two‐thirds reported increased adherence to their medicines, a finding both unanticipated and striking. More than 1 in 5 shared their notes with others. And in spite of doctors' worries, few found their notes confusing (2%8% of patients at the 3 sites), worried more (5%8%), or felt offended by their notes (1%2%). At the end of the year‐long intervention, 99% of patients returning surveys recommended that the practice continue.
PCPs reported virtually no impact on their workflow, although about 1 in 3 reported changing their documentation, given the knowledge that their patients might read their notes. Fewer than 5% of physicians reported visits taking more time, whereas 15% to 20% of physicians reported taking longer to write their notes. Approximately 30% of physicians reported changing the content of their notes to address obesity, substance abuse, mental health, or issues concerning malignancies. Of note, physicians were given an opt out function for any note, but they called on this very rarely during the study. And at the end of the year, not 1 PCP chose to discontinue offering patients his or her notes.
The 3 participating institutions felt that the trial was so successful that they decided to expand this practice aggressively. At BIDMC, OpenNotes will soon extend to all clinical departments and include all notes signed in the online record by doctors (including housestaff and fellows), nurses, social workers, physician assistants, clinical pharmacists, nutritionists, and occupational and physical therapists. The only exceptions will be those notes authored primarily by students, and those the clinician chooses to monitor, thereby blinding access to patients.
With stage 2 MU incentives in place, and the patient engagement movement accelerating, such practice will likely spread rapidly nationwide. We expect that more and more patients will be soon able to read all signed notes by hospitalists in real time. But differences abound among outpatients and inpatients, and PCPs and hospitalists, and inpatient notes are vastly different from those describing office visits. How may this change in practice affect hospitalized patients and their clinicians?
IMPLICATIONS FOR HOSPITALISTS
Most inpatients meet their hospitalists for the first time at admission. During their stay, they may encounter many hospitalists, along with multiple specialty consultants, house officers, nurses, and ancillary providers. Moreover, inpatient notes vary widely in their content and context. They may describe the patient tersely, while spelling out both a broad (and frightening) differential diagnosis, along with options for addressing a range of contingencies. Such notes, written during the acute diagnostic and treatment phase of an admission, tend to focus primarily on acute and discrete issues at hand, in contrast to outpatient notes that may take a more comprehensive approach. Moreover, given the enormous burden and acuity of illness today among many hospitalized patients, a large volume of data is generated in a very short period of time. Due both to time constraints and complexity, decisions are made quickly, often without the patient's input. When did you last ask a hospitalized patient if you could order specific blood tests? Unless a major therapeutic change is anticipated, how often are your patients told their results as a matter of course?
As acutely ill patients suddenly experience a life out of their control, how will they and their families respond to new access to a large volume of information? Should hospitalists expect an avalanche of questions, or might the prime impact be a change in the nature of those questions, as patients and their families move from What was the result? to What is the meaning of this result, given my condition? When the patient sees test results and reads consultant notes before the hospitalist has had a chance to review them, how will this impact the process of care and shape the patient's view of the hospitalist? When questions arise, will they discuss them immediately with their hospitalists, might they try to contact the doctor with whom they have an ongoing relationship, or will they wait until discharge to contact their PCPs? One hopes that offering patients ready access to their hospital record will foster trust and facilitate a positive relationship with hospitalists. But notes could also foster confusion and distrust, particularly if patients feel out of the loop and perceive differing opinions among those caring for them.
We anticipate that transparent records will stimulate hospitalists, PCPs, and other caregivers to improve communication throughout the patient's hospital stay. We know that medical errors occur with alarming frequency in all care settings, and unfortunately electronic medical records make it easier to spread erroneous information widely. As providers we are both morally and legally responsible for eliminating such errors, inviting the patient (and family) to review the chart may help prevent mistakes well before an adverse outcome ensues.
OPPORTUNITIES FOR IMPROVED CARE
Open notes will be viewed by many as a disruptive change, and the best strategy for adapting will be to move proactively to create policies that establish clear guidelines. Consider the following strategies:
- Draw on complex provider notes that may include potentially alarming differential diagnoses as an opportunity for engaging and educating the patient and caregiver.
- Try to avoid jargon and wording that patients may find objectionable, such as patient denies, poor historian, or even obese. Instead, use more situational wording, such as the patient was unclear on his history.
- Avoid abbreviations when possible. They are a frequent source of confusion among clinicians, let alone patients.
- When it is likely that a treatment may not succeed or a diagnosis may prove wrong, address contingency plans in your notes. Where possible, express likelihoods in terms consistent with the patient's level of comfort with numbers.
- Teach trainees to review notes with supervisors before signing.
- Explain to patients and families when they may expect to see your notes.
- Try rephrasing some of the technical content of notes. Move from incr. Cr FeNa=Prerenal, 1L IVF, to Due to dehydration (creatinine rising to 1.8, and fena 0.8), will give 1L IV fluids. Although at first blush this seems like more work, short circuiting need for explanation may save the hospitalist or nurse time later on. And clarity may lead to important additional history from the patient, furnishing perhaps insight into how he or she became dehydrated.
- Expect patients to download, copy, paste, and forward your note. Document with this in mind.
- Discuss with providers concerns about potential medicallegal risks and how to address them.
OpenNotes offers a special opportunity for improving the patient experience after leaving the hospital. For example, providing patients and their families with a medication list may be helpful, but a note adding context to medications may drive the reasoning home and prove vitally important, especially for those faced with complex medical regimens who may have poor health literacy.[7] Moreover, though providers are learning to focus on patient and family education during the discharge transition period in the hope of minimizing rehospitalizations, time spent at the bedside may have little impact.[8] Methods to improve patient/family understanding are often time consuming,[9, 10] and time is a luxury hospitalists rarely have. Providing patients full access to their providers' notes may mitigate confusion about salient aspects of the hospitalization or prompt timely questions, thereby facilitating a safe transition home.
Open access to notes should also help hospitalized patients engage a range of individuals well beyond those directly involved in their care. Patients will be increasingly likely to grant access to surrogates, whether through formal or informal mechanisms. Patients and their families may also forward notes to providers in other institutions, an activity that all too often falls between cracks. But such capabilities create both new opportunities and new challenges for hospitalists. On the 1 hand, they may find themselves more often in the difficult position of trying to arbitrate differences of opinion within a family. Alternatively, family members or friends, including health professionals offering informal consultation, may prove invaluable in helping hospitalists and patients agree on a plan of care developed collaboratively by a wide range of individuals.
FUTURE WORK
Opening hospital notes to patients will affect both clinicians and patients, and the hospital medicine community should begin to consider its options:
- Should we establish a formal curriculum designed to help hospitalists compose notes that will intelligently and efficiently engage patients?
- Can we identify best practice techniques for preparing notes that engage patients and families without overwhelming them?
- How can we use such notes to assure respect for the individual needs of patients and their families? How can we best assure maintaining their dignity?
- How can we use open notes to support patient safety? Can they reduce malpractice claims?
- How should we handle unsolicited second opinions initiated by patients and families who shared open notes with providers and others outside the care team?
- Should we encourage hospitals to offer portal access to all patients, including those who may have only a brief, passing relationship with the institution?
- What patient portal functions could best assist patients and families in understanding the content of inpatient notes?
- In the rapidly changing inpatient environment, how should we deal with patient‐initiated requests for corrections and changes to notes?
- Should all hospital notes be opened? Should clinicians be able to hide specific notes? Clinicians worry about medical record access for patients with mental illness; should patients with these or other specified conditions be exempted, and if so, how can one structure such processes openly and honestly?
The inexorable spread of fully open medical records requires rapid and intense intellectual scrutiny. Benefits will accompany risks, and unforeseen consequences are virtually inevitable. But this expression of transparency may soon constitute the standard of care in hospital medicine. We need to shape it carefully so that in inures to the benefit of both our patients and ourselves. Over time, we expect that inviting patients and their families to read notes openly will improve the quality of care and promote patient safety. We should take full advantage of such opportunity.
- , . New prescriptions: how well do patients remember important information? Fam Med. 2011;43(4):254–259.
- . Do physicians tell patients enough about prescription drugs? Do patients think so? Postgrad Med. 1983;74:169–175.
- , , . Early experiences with personal health records. J Am Med Inform Assoc. 2008;15:1–7.
- , , , et al. Open notes: doctors and patients signing on. Ann Intern Med. 2010;153(2):121–125.
- , , , Vodicka E, Darer JD, Dhanireddy S, Elmore JG, Feldman HJ, Lichtenfeld MJ, Oster N, Ralston JD, Ross S, Delbanco T. Inviting patients to read their doctors' notes: patients and doctors look ahead: patient and physician surveys. Ann Intern Med. 2011;155:811–819.
- , , , Darer JD, Elmore JG, Farag N, Feldman HJ, Mejilla R, Ngo L, Ralston JD, Ross SE, Trivedi N, Vodicka E, Leveille SG. Inviting patients to read their doctors' notes: a quasi‐experimental study and a look ahead. Ann Intern Med. 2012;157(7):461–470.
- , , , , . Hospital quality and patient safety competencies: development, description, and recommendations for use. J Hosp Med. 2011;6(9):530–536.
- , , , , , . The relationship between time spent communicating and communication outcomes on a hospital medicine service. J Gen Intern Med. 2012;27(2):185–189.
- , , , , . Is “teach‐back” associated with knowledge retention and hospital readmission in hospitalized heart failure patients? J Cardiovasc Nurs. 2013;28(2):137–146.
- , , ., “They never told us anything”: postdischarge instruction for families of persons with brain injuries. Rehabil Nurs.2001;26(2):48–53.
Can you explain why Dr. Johnson thinks I should be taking antibiotics, while your note says I shouldn't?
Today you may be surprised by such an inquiry during morning rounds, but such questions are likely coming to your wards. At a time of societal fascination both with transparency and the explosion of health information technologies, a growing number of hospitals are offering, or will soon offer, patients and their family instantaneous access to their doctors' and nurses' notes. What will this new opportunity for patient engagement mean for the hospitalist?
BACKGROUND
Helping patients through highly complicated care processes is no easy feat, and enabling patients and their families to deal successfully with a constantly changing scenario is a particular challenge for hospitalists. Multiple studies show how poorly patients recall information offered them in office visits,[1, 2] and such settings are far less stressful than the rapid fire mixture of procedures, multiple medications, and morbid disease processes that take center stage in so many hospitalizations. And now something new: What is in store for patients and their doctors when patients in a hospital room gain access in real time not only to test results, but also to notes written by their hospitalists, nurses, and consultants?
ENGAGING PATIENTS
With the principal goal of promoting more active patient engagement in care, patient portals designed primarily for ambulatory practice are proliferating rapidly. Not only do they offer patients windows into their records and secure ways to communicate with their providers, their goal is also to automate chores such as reporting results or other administrative tasks that take away from valuable face‐to‐face time between providers and patients. First appearing shortly after the dawn of the Internet, secure electronic portals began to offer patients access to much of their chart.[3] Rapidly evolving beyond limited data feeds over very simple connections, portals today share far more data, are spreading rapidly, and in some cases offer patients access to their entire records. Whether or not 1 record can serve all the traditional users and also the patient and family is a fascinating question,[4] but the fact is that patients can now access their records from their computers, and via smartphones and tablets on the go. While lying in hospital beds, they can gain access to their laboratory and test data as the data evolve, and sometimes the patients see the findings well before their busy clinicians. Moreover, family members, other informal caregivers, or a formally designated health care proxy, will access the patient's record as well, whether through documented proxy functions or by informally peering at the patient's tablet.
MEANINGFUL USE INCENTIVES
Today, state and federal government regulations either encourage or require healthcare providers to grant patients access to their clinical information. But despite the rules embedded in the federal Health Insurance Portability and Accountability Act, patients often face time‐consuming obstacles in their quest for access, and many providers view compliance as a burden. We suggest an alternative view. Over time, we anticipate that inviting patients to review their medical record will reduce risk, increase knowledge, foster active engagement, and help them take more control of their care.
With the goal also of reducing medical errors and improving outcomes, the expansion of portals is accompanied by a combination of incentives, and in the future, sanctions, as the Center for Medicare and Medicaid Services (CMS) refines efforts to promote certified electronic health record technologies that focus on meaningful use (MU), which often include patient engagement tools such as portals. In the fall of 2012, CMS announced stage 2 MU objectives, with several having substantial implications for hospitalists and their patients. One calls for providing patients the ability to view online, download and transmit their health information within 4 business days of the information being available to the provider. Rather than an outpatient‐only requirement, it is a practice‐based requirement, and we can soon expect hospitalist data to appear on portals.
INSIGHTS FROM TRANSPARENCY IN PRIMARY CARE
The OpenNotes trial provides clues as to how such practice will affect both patients and providers.[5, 6] The trial included patients and primary care physicians (PCPs) from 3 diverse settings: Beth Israel Deaconess Medical Center (BIDMC), an urban academic health center in Boston, Massachusetts, and affiliated community practices near Boston; Geisinger Health System, a primarily rural integrated health system in Pennsylvania; and adult medicine and human immunodeficiency virus clinics at Harborview Medical Center, a safety net hospital in Seattle, Washington. More than 100 volunteering PCPs invited 20,000 of their patients enrolled in their institution's portals to read their office visit notes over a 1‐year period. Physicianpatient messaging was tracked to examine impact on physician workloads, and patients and physicians were surveyed before and after the intervention.
The experience generated considerable enthusiasm and potential clinical benefits among the patients, with little adverse impact on patients and providers. Of particular relevance for hospitalists, more than 4 in 5 patients read their notes, with more than 70% reporting they understood their medical conditions better and felt more in control of their care, and two‐thirds reported increased adherence to their medicines, a finding both unanticipated and striking. More than 1 in 5 shared their notes with others. And in spite of doctors' worries, few found their notes confusing (2%8% of patients at the 3 sites), worried more (5%8%), or felt offended by their notes (1%2%). At the end of the year‐long intervention, 99% of patients returning surveys recommended that the practice continue.
PCPs reported virtually no impact on their workflow, although about 1 in 3 reported changing their documentation, given the knowledge that their patients might read their notes. Fewer than 5% of physicians reported visits taking more time, whereas 15% to 20% of physicians reported taking longer to write their notes. Approximately 30% of physicians reported changing the content of their notes to address obesity, substance abuse, mental health, or issues concerning malignancies. Of note, physicians were given an opt out function for any note, but they called on this very rarely during the study. And at the end of the year, not 1 PCP chose to discontinue offering patients his or her notes.
The 3 participating institutions felt that the trial was so successful that they decided to expand this practice aggressively. At BIDMC, OpenNotes will soon extend to all clinical departments and include all notes signed in the online record by doctors (including housestaff and fellows), nurses, social workers, physician assistants, clinical pharmacists, nutritionists, and occupational and physical therapists. The only exceptions will be those notes authored primarily by students, and those the clinician chooses to monitor, thereby blinding access to patients.
With stage 2 MU incentives in place, and the patient engagement movement accelerating, such practice will likely spread rapidly nationwide. We expect that more and more patients will be soon able to read all signed notes by hospitalists in real time. But differences abound among outpatients and inpatients, and PCPs and hospitalists, and inpatient notes are vastly different from those describing office visits. How may this change in practice affect hospitalized patients and their clinicians?
IMPLICATIONS FOR HOSPITALISTS
Most inpatients meet their hospitalists for the first time at admission. During their stay, they may encounter many hospitalists, along with multiple specialty consultants, house officers, nurses, and ancillary providers. Moreover, inpatient notes vary widely in their content and context. They may describe the patient tersely, while spelling out both a broad (and frightening) differential diagnosis, along with options for addressing a range of contingencies. Such notes, written during the acute diagnostic and treatment phase of an admission, tend to focus primarily on acute and discrete issues at hand, in contrast to outpatient notes that may take a more comprehensive approach. Moreover, given the enormous burden and acuity of illness today among many hospitalized patients, a large volume of data is generated in a very short period of time. Due both to time constraints and complexity, decisions are made quickly, often without the patient's input. When did you last ask a hospitalized patient if you could order specific blood tests? Unless a major therapeutic change is anticipated, how often are your patients told their results as a matter of course?
As acutely ill patients suddenly experience a life out of their control, how will they and their families respond to new access to a large volume of information? Should hospitalists expect an avalanche of questions, or might the prime impact be a change in the nature of those questions, as patients and their families move from What was the result? to What is the meaning of this result, given my condition? When the patient sees test results and reads consultant notes before the hospitalist has had a chance to review them, how will this impact the process of care and shape the patient's view of the hospitalist? When questions arise, will they discuss them immediately with their hospitalists, might they try to contact the doctor with whom they have an ongoing relationship, or will they wait until discharge to contact their PCPs? One hopes that offering patients ready access to their hospital record will foster trust and facilitate a positive relationship with hospitalists. But notes could also foster confusion and distrust, particularly if patients feel out of the loop and perceive differing opinions among those caring for them.
We anticipate that transparent records will stimulate hospitalists, PCPs, and other caregivers to improve communication throughout the patient's hospital stay. We know that medical errors occur with alarming frequency in all care settings, and unfortunately electronic medical records make it easier to spread erroneous information widely. As providers we are both morally and legally responsible for eliminating such errors, inviting the patient (and family) to review the chart may help prevent mistakes well before an adverse outcome ensues.
OPPORTUNITIES FOR IMPROVED CARE
Open notes will be viewed by many as a disruptive change, and the best strategy for adapting will be to move proactively to create policies that establish clear guidelines. Consider the following strategies:
- Draw on complex provider notes that may include potentially alarming differential diagnoses as an opportunity for engaging and educating the patient and caregiver.
- Try to avoid jargon and wording that patients may find objectionable, such as patient denies, poor historian, or even obese. Instead, use more situational wording, such as the patient was unclear on his history.
- Avoid abbreviations when possible. They are a frequent source of confusion among clinicians, let alone patients.
- When it is likely that a treatment may not succeed or a diagnosis may prove wrong, address contingency plans in your notes. Where possible, express likelihoods in terms consistent with the patient's level of comfort with numbers.
- Teach trainees to review notes with supervisors before signing.
- Explain to patients and families when they may expect to see your notes.
- Try rephrasing some of the technical content of notes. Move from incr. Cr FeNa=Prerenal, 1L IVF, to Due to dehydration (creatinine rising to 1.8, and fena 0.8), will give 1L IV fluids. Although at first blush this seems like more work, short circuiting need for explanation may save the hospitalist or nurse time later on. And clarity may lead to important additional history from the patient, furnishing perhaps insight into how he or she became dehydrated.
- Expect patients to download, copy, paste, and forward your note. Document with this in mind.
- Discuss with providers concerns about potential medicallegal risks and how to address them.
OpenNotes offers a special opportunity for improving the patient experience after leaving the hospital. For example, providing patients and their families with a medication list may be helpful, but a note adding context to medications may drive the reasoning home and prove vitally important, especially for those faced with complex medical regimens who may have poor health literacy.[7] Moreover, though providers are learning to focus on patient and family education during the discharge transition period in the hope of minimizing rehospitalizations, time spent at the bedside may have little impact.[8] Methods to improve patient/family understanding are often time consuming,[9, 10] and time is a luxury hospitalists rarely have. Providing patients full access to their providers' notes may mitigate confusion about salient aspects of the hospitalization or prompt timely questions, thereby facilitating a safe transition home.
Open access to notes should also help hospitalized patients engage a range of individuals well beyond those directly involved in their care. Patients will be increasingly likely to grant access to surrogates, whether through formal or informal mechanisms. Patients and their families may also forward notes to providers in other institutions, an activity that all too often falls between cracks. But such capabilities create both new opportunities and new challenges for hospitalists. On the 1 hand, they may find themselves more often in the difficult position of trying to arbitrate differences of opinion within a family. Alternatively, family members or friends, including health professionals offering informal consultation, may prove invaluable in helping hospitalists and patients agree on a plan of care developed collaboratively by a wide range of individuals.
FUTURE WORK
Opening hospital notes to patients will affect both clinicians and patients, and the hospital medicine community should begin to consider its options:
- Should we establish a formal curriculum designed to help hospitalists compose notes that will intelligently and efficiently engage patients?
- Can we identify best practice techniques for preparing notes that engage patients and families without overwhelming them?
- How can we use such notes to assure respect for the individual needs of patients and their families? How can we best assure maintaining their dignity?
- How can we use open notes to support patient safety? Can they reduce malpractice claims?
- How should we handle unsolicited second opinions initiated by patients and families who shared open notes with providers and others outside the care team?
- Should we encourage hospitals to offer portal access to all patients, including those who may have only a brief, passing relationship with the institution?
- What patient portal functions could best assist patients and families in understanding the content of inpatient notes?
- In the rapidly changing inpatient environment, how should we deal with patient‐initiated requests for corrections and changes to notes?
- Should all hospital notes be opened? Should clinicians be able to hide specific notes? Clinicians worry about medical record access for patients with mental illness; should patients with these or other specified conditions be exempted, and if so, how can one structure such processes openly and honestly?
The inexorable spread of fully open medical records requires rapid and intense intellectual scrutiny. Benefits will accompany risks, and unforeseen consequences are virtually inevitable. But this expression of transparency may soon constitute the standard of care in hospital medicine. We need to shape it carefully so that in inures to the benefit of both our patients and ourselves. Over time, we expect that inviting patients and their families to read notes openly will improve the quality of care and promote patient safety. We should take full advantage of such opportunity.
Can you explain why Dr. Johnson thinks I should be taking antibiotics, while your note says I shouldn't?
Today you may be surprised by such an inquiry during morning rounds, but such questions are likely coming to your wards. At a time of societal fascination both with transparency and the explosion of health information technologies, a growing number of hospitals are offering, or will soon offer, patients and their family instantaneous access to their doctors' and nurses' notes. What will this new opportunity for patient engagement mean for the hospitalist?
BACKGROUND
Helping patients through highly complicated care processes is no easy feat, and enabling patients and their families to deal successfully with a constantly changing scenario is a particular challenge for hospitalists. Multiple studies show how poorly patients recall information offered them in office visits,[1, 2] and such settings are far less stressful than the rapid fire mixture of procedures, multiple medications, and morbid disease processes that take center stage in so many hospitalizations. And now something new: What is in store for patients and their doctors when patients in a hospital room gain access in real time not only to test results, but also to notes written by their hospitalists, nurses, and consultants?
ENGAGING PATIENTS
With the principal goal of promoting more active patient engagement in care, patient portals designed primarily for ambulatory practice are proliferating rapidly. Not only do they offer patients windows into their records and secure ways to communicate with their providers, their goal is also to automate chores such as reporting results or other administrative tasks that take away from valuable face‐to‐face time between providers and patients. First appearing shortly after the dawn of the Internet, secure electronic portals began to offer patients access to much of their chart.[3] Rapidly evolving beyond limited data feeds over very simple connections, portals today share far more data, are spreading rapidly, and in some cases offer patients access to their entire records. Whether or not 1 record can serve all the traditional users and also the patient and family is a fascinating question,[4] but the fact is that patients can now access their records from their computers, and via smartphones and tablets on the go. While lying in hospital beds, they can gain access to their laboratory and test data as the data evolve, and sometimes the patients see the findings well before their busy clinicians. Moreover, family members, other informal caregivers, or a formally designated health care proxy, will access the patient's record as well, whether through documented proxy functions or by informally peering at the patient's tablet.
MEANINGFUL USE INCENTIVES
Today, state and federal government regulations either encourage or require healthcare providers to grant patients access to their clinical information. But despite the rules embedded in the federal Health Insurance Portability and Accountability Act, patients often face time‐consuming obstacles in their quest for access, and many providers view compliance as a burden. We suggest an alternative view. Over time, we anticipate that inviting patients to review their medical record will reduce risk, increase knowledge, foster active engagement, and help them take more control of their care.
With the goal also of reducing medical errors and improving outcomes, the expansion of portals is accompanied by a combination of incentives, and in the future, sanctions, as the Center for Medicare and Medicaid Services (CMS) refines efforts to promote certified electronic health record technologies that focus on meaningful use (MU), which often include patient engagement tools such as portals. In the fall of 2012, CMS announced stage 2 MU objectives, with several having substantial implications for hospitalists and their patients. One calls for providing patients the ability to view online, download and transmit their health information within 4 business days of the information being available to the provider. Rather than an outpatient‐only requirement, it is a practice‐based requirement, and we can soon expect hospitalist data to appear on portals.
INSIGHTS FROM TRANSPARENCY IN PRIMARY CARE
The OpenNotes trial provides clues as to how such practice will affect both patients and providers.[5, 6] The trial included patients and primary care physicians (PCPs) from 3 diverse settings: Beth Israel Deaconess Medical Center (BIDMC), an urban academic health center in Boston, Massachusetts, and affiliated community practices near Boston; Geisinger Health System, a primarily rural integrated health system in Pennsylvania; and adult medicine and human immunodeficiency virus clinics at Harborview Medical Center, a safety net hospital in Seattle, Washington. More than 100 volunteering PCPs invited 20,000 of their patients enrolled in their institution's portals to read their office visit notes over a 1‐year period. Physicianpatient messaging was tracked to examine impact on physician workloads, and patients and physicians were surveyed before and after the intervention.
The experience generated considerable enthusiasm and potential clinical benefits among the patients, with little adverse impact on patients and providers. Of particular relevance for hospitalists, more than 4 in 5 patients read their notes, with more than 70% reporting they understood their medical conditions better and felt more in control of their care, and two‐thirds reported increased adherence to their medicines, a finding both unanticipated and striking. More than 1 in 5 shared their notes with others. And in spite of doctors' worries, few found their notes confusing (2%8% of patients at the 3 sites), worried more (5%8%), or felt offended by their notes (1%2%). At the end of the year‐long intervention, 99% of patients returning surveys recommended that the practice continue.
PCPs reported virtually no impact on their workflow, although about 1 in 3 reported changing their documentation, given the knowledge that their patients might read their notes. Fewer than 5% of physicians reported visits taking more time, whereas 15% to 20% of physicians reported taking longer to write their notes. Approximately 30% of physicians reported changing the content of their notes to address obesity, substance abuse, mental health, or issues concerning malignancies. Of note, physicians were given an opt out function for any note, but they called on this very rarely during the study. And at the end of the year, not 1 PCP chose to discontinue offering patients his or her notes.
The 3 participating institutions felt that the trial was so successful that they decided to expand this practice aggressively. At BIDMC, OpenNotes will soon extend to all clinical departments and include all notes signed in the online record by doctors (including housestaff and fellows), nurses, social workers, physician assistants, clinical pharmacists, nutritionists, and occupational and physical therapists. The only exceptions will be those notes authored primarily by students, and those the clinician chooses to monitor, thereby blinding access to patients.
With stage 2 MU incentives in place, and the patient engagement movement accelerating, such practice will likely spread rapidly nationwide. We expect that more and more patients will be soon able to read all signed notes by hospitalists in real time. But differences abound among outpatients and inpatients, and PCPs and hospitalists, and inpatient notes are vastly different from those describing office visits. How may this change in practice affect hospitalized patients and their clinicians?
IMPLICATIONS FOR HOSPITALISTS
Most inpatients meet their hospitalists for the first time at admission. During their stay, they may encounter many hospitalists, along with multiple specialty consultants, house officers, nurses, and ancillary providers. Moreover, inpatient notes vary widely in their content and context. They may describe the patient tersely, while spelling out both a broad (and frightening) differential diagnosis, along with options for addressing a range of contingencies. Such notes, written during the acute diagnostic and treatment phase of an admission, tend to focus primarily on acute and discrete issues at hand, in contrast to outpatient notes that may take a more comprehensive approach. Moreover, given the enormous burden and acuity of illness today among many hospitalized patients, a large volume of data is generated in a very short period of time. Due both to time constraints and complexity, decisions are made quickly, often without the patient's input. When did you last ask a hospitalized patient if you could order specific blood tests? Unless a major therapeutic change is anticipated, how often are your patients told their results as a matter of course?
As acutely ill patients suddenly experience a life out of their control, how will they and their families respond to new access to a large volume of information? Should hospitalists expect an avalanche of questions, or might the prime impact be a change in the nature of those questions, as patients and their families move from What was the result? to What is the meaning of this result, given my condition? When the patient sees test results and reads consultant notes before the hospitalist has had a chance to review them, how will this impact the process of care and shape the patient's view of the hospitalist? When questions arise, will they discuss them immediately with their hospitalists, might they try to contact the doctor with whom they have an ongoing relationship, or will they wait until discharge to contact their PCPs? One hopes that offering patients ready access to their hospital record will foster trust and facilitate a positive relationship with hospitalists. But notes could also foster confusion and distrust, particularly if patients feel out of the loop and perceive differing opinions among those caring for them.
We anticipate that transparent records will stimulate hospitalists, PCPs, and other caregivers to improve communication throughout the patient's hospital stay. We know that medical errors occur with alarming frequency in all care settings, and unfortunately electronic medical records make it easier to spread erroneous information widely. As providers we are both morally and legally responsible for eliminating such errors, inviting the patient (and family) to review the chart may help prevent mistakes well before an adverse outcome ensues.
OPPORTUNITIES FOR IMPROVED CARE
Open notes will be viewed by many as a disruptive change, and the best strategy for adapting will be to move proactively to create policies that establish clear guidelines. Consider the following strategies:
- Draw on complex provider notes that may include potentially alarming differential diagnoses as an opportunity for engaging and educating the patient and caregiver.
- Try to avoid jargon and wording that patients may find objectionable, such as patient denies, poor historian, or even obese. Instead, use more situational wording, such as the patient was unclear on his history.
- Avoid abbreviations when possible. They are a frequent source of confusion among clinicians, let alone patients.
- When it is likely that a treatment may not succeed or a diagnosis may prove wrong, address contingency plans in your notes. Where possible, express likelihoods in terms consistent with the patient's level of comfort with numbers.
- Teach trainees to review notes with supervisors before signing.
- Explain to patients and families when they may expect to see your notes.
- Try rephrasing some of the technical content of notes. Move from incr. Cr FeNa=Prerenal, 1L IVF, to Due to dehydration (creatinine rising to 1.8, and fena 0.8), will give 1L IV fluids. Although at first blush this seems like more work, short circuiting need for explanation may save the hospitalist or nurse time later on. And clarity may lead to important additional history from the patient, furnishing perhaps insight into how he or she became dehydrated.
- Expect patients to download, copy, paste, and forward your note. Document with this in mind.
- Discuss with providers concerns about potential medicallegal risks and how to address them.
OpenNotes offers a special opportunity for improving the patient experience after leaving the hospital. For example, providing patients and their families with a medication list may be helpful, but a note adding context to medications may drive the reasoning home and prove vitally important, especially for those faced with complex medical regimens who may have poor health literacy.[7] Moreover, though providers are learning to focus on patient and family education during the discharge transition period in the hope of minimizing rehospitalizations, time spent at the bedside may have little impact.[8] Methods to improve patient/family understanding are often time consuming,[9, 10] and time is a luxury hospitalists rarely have. Providing patients full access to their providers' notes may mitigate confusion about salient aspects of the hospitalization or prompt timely questions, thereby facilitating a safe transition home.
Open access to notes should also help hospitalized patients engage a range of individuals well beyond those directly involved in their care. Patients will be increasingly likely to grant access to surrogates, whether through formal or informal mechanisms. Patients and their families may also forward notes to providers in other institutions, an activity that all too often falls between cracks. But such capabilities create both new opportunities and new challenges for hospitalists. On the 1 hand, they may find themselves more often in the difficult position of trying to arbitrate differences of opinion within a family. Alternatively, family members or friends, including health professionals offering informal consultation, may prove invaluable in helping hospitalists and patients agree on a plan of care developed collaboratively by a wide range of individuals.
FUTURE WORK
Opening hospital notes to patients will affect both clinicians and patients, and the hospital medicine community should begin to consider its options:
- Should we establish a formal curriculum designed to help hospitalists compose notes that will intelligently and efficiently engage patients?
- Can we identify best practice techniques for preparing notes that engage patients and families without overwhelming them?
- How can we use such notes to assure respect for the individual needs of patients and their families? How can we best assure maintaining their dignity?
- How can we use open notes to support patient safety? Can they reduce malpractice claims?
- How should we handle unsolicited second opinions initiated by patients and families who shared open notes with providers and others outside the care team?
- Should we encourage hospitals to offer portal access to all patients, including those who may have only a brief, passing relationship with the institution?
- What patient portal functions could best assist patients and families in understanding the content of inpatient notes?
- In the rapidly changing inpatient environment, how should we deal with patient‐initiated requests for corrections and changes to notes?
- Should all hospital notes be opened? Should clinicians be able to hide specific notes? Clinicians worry about medical record access for patients with mental illness; should patients with these or other specified conditions be exempted, and if so, how can one structure such processes openly and honestly?
The inexorable spread of fully open medical records requires rapid and intense intellectual scrutiny. Benefits will accompany risks, and unforeseen consequences are virtually inevitable. But this expression of transparency may soon constitute the standard of care in hospital medicine. We need to shape it carefully so that in inures to the benefit of both our patients and ourselves. Over time, we expect that inviting patients and their families to read notes openly will improve the quality of care and promote patient safety. We should take full advantage of such opportunity.
- , . New prescriptions: how well do patients remember important information? Fam Med. 2011;43(4):254–259.
- . Do physicians tell patients enough about prescription drugs? Do patients think so? Postgrad Med. 1983;74:169–175.
- , , . Early experiences with personal health records. J Am Med Inform Assoc. 2008;15:1–7.
- , , , et al. Open notes: doctors and patients signing on. Ann Intern Med. 2010;153(2):121–125.
- , , , Vodicka E, Darer JD, Dhanireddy S, Elmore JG, Feldman HJ, Lichtenfeld MJ, Oster N, Ralston JD, Ross S, Delbanco T. Inviting patients to read their doctors' notes: patients and doctors look ahead: patient and physician surveys. Ann Intern Med. 2011;155:811–819.
- , , , Darer JD, Elmore JG, Farag N, Feldman HJ, Mejilla R, Ngo L, Ralston JD, Ross SE, Trivedi N, Vodicka E, Leveille SG. Inviting patients to read their doctors' notes: a quasi‐experimental study and a look ahead. Ann Intern Med. 2012;157(7):461–470.
- , , , , . Hospital quality and patient safety competencies: development, description, and recommendations for use. J Hosp Med. 2011;6(9):530–536.
- , , , , , . The relationship between time spent communicating and communication outcomes on a hospital medicine service. J Gen Intern Med. 2012;27(2):185–189.
- , , , , . Is “teach‐back” associated with knowledge retention and hospital readmission in hospitalized heart failure patients? J Cardiovasc Nurs. 2013;28(2):137–146.
- , , ., “They never told us anything”: postdischarge instruction for families of persons with brain injuries. Rehabil Nurs.2001;26(2):48–53.
- , . New prescriptions: how well do patients remember important information? Fam Med. 2011;43(4):254–259.
- . Do physicians tell patients enough about prescription drugs? Do patients think so? Postgrad Med. 1983;74:169–175.
- , , . Early experiences with personal health records. J Am Med Inform Assoc. 2008;15:1–7.
- , , , et al. Open notes: doctors and patients signing on. Ann Intern Med. 2010;153(2):121–125.
- , , , Vodicka E, Darer JD, Dhanireddy S, Elmore JG, Feldman HJ, Lichtenfeld MJ, Oster N, Ralston JD, Ross S, Delbanco T. Inviting patients to read their doctors' notes: patients and doctors look ahead: patient and physician surveys. Ann Intern Med. 2011;155:811–819.
- , , , Darer JD, Elmore JG, Farag N, Feldman HJ, Mejilla R, Ngo L, Ralston JD, Ross SE, Trivedi N, Vodicka E, Leveille SG. Inviting patients to read their doctors' notes: a quasi‐experimental study and a look ahead. Ann Intern Med. 2012;157(7):461–470.
- , , , , . Hospital quality and patient safety competencies: development, description, and recommendations for use. J Hosp Med. 2011;6(9):530–536.
- , , , , , . The relationship between time spent communicating and communication outcomes on a hospital medicine service. J Gen Intern Med. 2012;27(2):185–189.
- , , , , . Is “teach‐back” associated with knowledge retention and hospital readmission in hospitalized heart failure patients? J Cardiovasc Nurs. 2013;28(2):137–146.
- , , ., “They never told us anything”: postdischarge instruction for families of persons with brain injuries. Rehabil Nurs.2001;26(2):48–53.
In the Literature
In This Edition
- Treat with antibiotics for seven days or less in adults with community-acquired pneumonia.
- In patients with chronic kidney disease who present with non ST-segment elevation acute coronary syndromes, anticoagulation with fondaparinux (Arixtra) is safer than with enoxaparin (Lovenox).
- Multislice coronary angiography rules out suspected coronary artery disease.
- Hospitalists in teaching hospitals decrease length of stay in complex patients.
- Epoetin alfa (Procrit/Epogen) use in critically ill patients does not reduce red-cell transfusion but may reduce mortality in trauma.
- Newer antibiotics appear to be more effective for acute exacerbations of chronic bronchitis.
- Low-income patients and patients seen by specialists are less likely to use generic medications.
- Hospitalist-orthopedic comanagement of patients with hip fractures does not negatively affect long-term mortality.
- Probiotics reduce antibiotic and C. difficile-associated diarrhea.
- Healthcare-associated pneumonia closely resembles nosocomial pneumonia.
What Is the Appropriate Duration of Antibiotic Therapy for Adults with CAP?
Background: Community-acquired pneumonia (CAP) is a leading cause of morbidity and mortality, but there is little consensus on the appropriate duration of antibiotic therapy. Current guidelines recommend antibiotic regimens lasting from five to 14 days. Shorter courses of antibiotic therapy may improve patient compliance, reduce risk of medication related adverse effects, and minimize the risk of antimicrobial resistance.
Study design: Meta-analysis.
Synopsis: Authors included 15 randomized controlled trials from 1990 through 2004. They compared the efficacy of short-course (seven days or less) antibiotic monotherapy versus extended regimens (longer than seven days) in patients age 12 or older with mild to moderate CAP. They excluded trials with a significant number of patients with bronchitis, healthcare-associated pneumonias, and chronic obstructive pulmonary disease exacerbations. The primary outcome measure failed to achieve clinical improvement or cure. Secondary outcome measures included mortality, bacteriologic failure, and other adverse events.
The authors found no significant differences in the risk of clinical failure, risk of mortality, risk of bacteriologic failure, or risk of adverse events in the short-course versus extended-course antibiotic regimens. This was consistent among the four antibiotic classes in the study: beta-lactam, fluoroquinolone, ketolide, and macrolide.
Bottom line: This study found no differences between short-course and extended-course antibiotic regimens in the treatment of adults with mild to moderate CAP in regard to clinical success, mortality, bacteriologic success, and adverse events.
Citation: Li JZ, Winston LG, Moore DH, et al. Efficacy of short-course antibiotic regimens for CAP: A meta-analysis. Am J Med. 2007;120(9):783-790.
Is Fondaparinux Superior to Enoxaparin in Non-ST-Elevation Acute Coronary Syndromes?
Background: Fondaparinux is a selective factor Xa inhibitor approved by the FDA for the treatment and prevention of venous thromboembolism. The Organization to Assess Strategies for Ischemic Syndromes (OASIS)-5 was a randomized, double-blind trial that demonstrated fondaparinux is similar to enoxaparin in reducing the risk of ischemic events, but substantially reduces major bleeding, long-term mortality, and morbidity.1
Study design: Subgroup analysis of a randomized, controlled trial.
Setting: Hospitals to which patients with non-ST-segment elevation acute coronary syndrome presented.
Synopsis: In a subgroup analysis of 19,979 in the OASIS-5 trial, patients were divided into quartiles based on their estimated creatinine clearance, calculated by using the Modification of Diet in Renal Disease formula.2 Death, myocardial infarction, refractory ischemia, and major bleeding were evaluated separately, and as a composite end point at nine, 30, and 180 days.
At nine days, death, myocardial infarction, or refractory ischemia occurred in 6.7% of patients receiving fondaparinux and 7.4% of those receiving enoxaparin (hazard ratio, 0.90, 95% confidence interval [CI], 0.73 to 1.11); major bleeding occurred in 2.8% and 6.4%, respectively (hazard ratio, 0.42, CI, 0.32 to 0.56). Statistically significant differences in major bleeding persisted at 30 and 180 days.
While there was a trend toward a reduction in the composite end point among all quartiles of glomerular filtration rate (GFR), the differences were statistically significant only among patients with a GFR less than 58 mL/min per 1.73 m2. The authors concluded that the absolute differences in favor of fondaparinux (efficacy and safety) were most apparent in patients with a GFR less than 58 mL/min per 1.73 m2 and were largely the result in a reduction in bleeding events.
The subgroup analysis was not planned before the OASIS-5 data were collected, and the results have not been confirmed elsewhere. For patients managed with an early invasive strategy, catheter thrombosis occurred more often in those who received fondaparinux than enoxaparin alone. Fondaparinux is not FDA approved for this indication.
Bottom line: In patients with chronic kidney disease who present with non ST-segment elevation acute coronary syndromes, anticoagulation with fondaparinux is associated with a significant reduction in the incidence of major bleeding as compared with enoxaparin.
Citations:
- Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med. 2006;354(14):1464-1476.
- Fox KA, Bassand JP, Mehta SR, et al. Influence of renal function on the efficacy and safety of fondaparinux relative to enoxaparin in non ST-segment elevation acute coronary syndromes. Ann Intern Med. 2007;147(5):304-310.
What’s the Prognosis of Asymptomatic Patients with Suspected Coronary Artery Disease with Normal Multislice Angiogram?
Background: Several studies have demonstrated high sensitivity and negative predictive values for computed tomography (CT) coronary angiography.
Study design: Prospective, sequentially enrolled subjects.
Synopsis: A CT angiogram was given to 182 consecutive patients scheduled for conventional coronary angiography without acute coronary syndrome and insufficient coronary calcification to limit CT angiography. Researchers enrolled 141 because CT angiography was inconclusive or warranted actual conventional angiography.
These normal CT angiogram subjects were followed for a mean time of 14.7 months without loss to follow-up or any mortality. Five subsequently underwent conventional angiography eight to 11 months following CT, and three had clinically significant single-vessel disease. The other two had normal conventional angiograms. There was one myocardial infarction patient who, upon further review of CT, had previously unappreciated right-coronary-artery (RCA) disease. This prospective study demonstrated a 97.2% negative predictive value consistent with previous studies. Mortality, myocardial infarction, and subsequently identified coronary artery disease (CAD) are also consistent with previously published data for conventional angiography.
Bottom line: In this small, prospective study, multislice CT coronary angiography safely rules out suspected CAD.
Citation: Gilard M, Le Gal G, Cornily JC, et al. Midterm prognosis of patients with suspected coronary artery disease and normal multislice computer tomographic findings. Arch Intern Med. 2007;165(15):1687-1689.
Does Epoetin Alfa Reduce Need for Blood Transfusion Therapy in Critically Ill Patients?
Background: Two prior studies demonstrated that the use of epoetin reduced the number of red-cell transfusions in ICU patients without any other clinical benefits. There were possible subgroup differences between trauma and nontrauma patients. This study assessed a reduced dose of epoetin alfa and evaluated clinical outcomes and subgroup differences suggested by the previous studies.
Study design: Prospective, randomized, double-blind, placebo-controlled clinical trial.
Setting: 115 medical centers.
Synopsis: The study group of 1,460 patients underwent stratified randomization into trauma, surgical nontrauma, and medical nontrauma groups. There were no significant differences in transfusion requirements between the epoetin group, the placebo group, or in any subgroup. The mean pre-transfusion hemoglobin was the same in each group.
The epoetin group had a higher-than-baseline hemoglobin level at day 29 (1.6 versus 1.2 g/dL, p<0.001) and a higher absolute hemoglobin (11.2 versus 10.8 g/dL, p<0.001) than the placebo group. Mortality was lower in the epoetin group (8.5% versus 11.4%, p=0.02) and in the trauma subgroup (3.5% versus 6.6%, p=0.04). In two nontrauma groups, point estimates demonstrated similar lower mortality but were not statistically significant.
Thrombotic vascular events were higher in the epoetin group than the placebo group (16.5% versus 11.5%, p=0.008), but post-hoc analyses demonstrated that the effect was only observed in patients who had not received heparin at baseline. There were no other observed differences in length of stay or use of mechanical ventilation.
Bottom line: Epoetin alfa does not reduce red blood cell transfusions in ICU patients but may reduce mortality in trauma patients. Increased thrombotic events may be mitigated with the use of heparin.
Citation: Corwin HL, Gettinger A, Fabian TC, et al. Efficacy and safety of epoetin alfa in critically ill patients. N Engl J Med. 2007;357 (10):965-976.
What Patients Benefit Most from Hospitalist Care in an Academic Medical Center?
Background: Hospitalists increasingly serve as teaching attending physicians at many academic medical centers. Studies have shown hospitalists’ care can reduce the length of hospital stay in patients with a limited number of specific diagnoses. It has not been established whether there are other specific patient diagnoses or discharge dispositions that might benefit from hospitalist care in a teaching hospital.
Study design: Retrospective cohort.
Setting: Urban teaching hospital.
Synopsis: The authors examined the patients discharged from a hospitalist and a non-hospitalist teaching attending service at an academic medical center during a two-year period beginning July 1, 2002. The length of hospital stay for patients on the hospitalist teaching attending service was significantly lower than that of the non-hospitalist teaching attending service. This difference was most pronounced in patients with highest overall acuity as measured by diagnosis-related group (DRG) weight and patients who required discharge to nursing facilities.
Bottom line: Medically complex inpatients and inpatients with complex discharge planning needs appear to have a shorter length of hospital stay when under the care of hospitalists serving as teaching attending physicians compared with non-hospitalist teaching attending physicians.
Citation: Southern WN, Berger MA, Bellin EY, et al. Hospitalist care and length of stay in patients requiring complex discharge planning and close clinical monitoring. Arch Intern Med. 2007;167(17):1869-1874.
What Influences Use of Generic, Branded Medications?
Background: Expenditures for prescription medications exceeded $250 billion in 2005. Various patient, physician, and payment factors may increase generic drug use in an attempt to reduce costs without affecting quality of care.
Study design: Observational analysis.
Synopsis: This study analyzed initial and subsequent pharmacy claims for 5,399 patients enrolled in a large health plan in the western United States, from 2001-2003. For new prescriptions, 23% were generics. Initiation of generic medications was less likely for patients in poor neighborhoods and for prescriptions written by specialists; pharmacy benefit design and pharmacy type did not have a significant influence.
After initiation of branded medications, 15% switched to generics during the study follow-up. Patients were more likely to switch to generic medications if they were older, if they used mail-order pharmacies, or if they participated in multitier (three or more) co-payment plans.
Bottom line: Low-income patients and patients who see specialists are less likely to initiate generic medications; after initiation on branded medications, patients using mail-order pharmacies or multitier co-payment systems are more likely to switch to generics.
Citation: Shrank WH, Stedman M, Ettner SL, et al. Patient, physician, pharmacy, and pharmacy benefit design factors related to generic medication use. J Gen Intern Med. 2007; 22:1298-1304.
Does Orthopedic Comanagement Increase Mortality in Elderly Hip Fracture Patients?
Background: Prior studies have demonstrated that for patients with hip fracture, a hospitalist-orthopedic comanagement management service reduced time to surgery and length of stay, with no difference in inpatient mortality. This study sought to address whether this applied to long-term mortality as well.
Study design: Retrospective cohort study.
Setting: Tertiary care center.
Synopsis: This study examined 466 patients admitted consecutively to a tertiary care center for surgical repair of a hip fracture, and followed them for one year postoperatively. It compared outcomes for patients admitted to a hospitalist-orthopedic comanagement service (2001-2002) with a standard care group of historical controls admitted to either an orthopedic or general medical teaching service (2000-2001).
One-year survival did not differ between the patients on the hospitalist-orthopedic comanagement service (70.5%) versus those in the standard care group (70.6%). The hospitalist-orthopedic comanagement model was associated with shorter time to surgery and shorter length of stay (8.4 versus 10.6 days). According to multivariate analysis, independent predictors of mortality were: American Society of Anesthesiologists (ASA) class III or IV (hazard ratio 4.2, 95% CI, 2.21, 7.99), admission from a nursing home (hazard ratio 2.24, 95% CI, 1.73, 2.90), and inpatient complications such as renal failure, myocardial infarction, or ICU admission (hazard ratio 1.85, CI 95%, 1.45, 2.35).
The authors note that prior studies demonstrated benefits from hospitalist involvement only after one year of implementation. This study was performed during the first year of the hospitalist-orthopedic comanagement team.
Bottom line: Hospitalist-orthopedic comanagement of patients with hip fracture reduces length of stay and does not negatively affect long-term mortality.
Citation: Batsis JA, Phy MP, Melton LJ, et al. Effects of a hospitalist care model on mortality of elderly patients with hip fractures. J Hosp Med. 2007;2:219-225.
How Effective Are First-Line, Second-Line Antibiotics for AECB?
Background: Antibiotics are frequently used for treatment of acute exacerbations of chronic bronchitis (AECB). However, in this era of increasing microbial resistance, there are insufficient data comparing the efficacy and safety of first-line antibiotics (ampicillin, amoxicillin, doxycycline, trimethoprim-sulfamethoxazole [Bactrim, Cotrima, Septra]) with second-line antibiotics (amoxicillin-clavulanic acid [Augmentin], macrolides, second- and third-generation cephalosporins, and fluoroquinolones).
Study design: Meta-analysis of randomized controlled trials (RCT).
Synopsis: Authors included 12 RCTs from 1981 to 2000, enrolling 2,261 adult patients comparing the efficacy and toxicity of first-line with second-line antibiotics for AECB in inpatient and outpatient settings. The authors measured treatment success, drug-related adverse events, all-cause mortality and pathogen eradication.
They concluded that administration of first-line antibiotics was associated with lower treatment success than administration of second-line antibiotics (odd ratio [OR] 0.51, 95% CI, 0.34 to 0.75). However, no differences were found with regard to all-cause mortality (OR 0.64, 95% CI, 0.25 to 3.35), adverse effects (OR 0.75, 95% CI, 0.39 to 1.45), or treatment success in microbiologically evaluable patients (OR 0.56, 95% CI, 0.22 to 1.43). Some limitations of this meta-analysis include:
- Inadequate data to stratify patients according to risk factors for poor outcome;
- Trials included inpatients as well as outpatients (likely with varying disease severity); and
- Trials were conducted in different time periods with changing patterns of anti-microbial resistance.
Bottom line: In patients with AECB, second-line antibiotics are more effective than first-line antibiotics with no differences in safety or mortality.
Citation: Dimopoulos G, Siempos II, Korbila IP, et al. Comparison of first-line with second-line antibiotics for acute exacerbations of chronic bronchitis. Chest. 2007;132:447-455.
Do Probiotic Drinks Reduce Antibiotic-Associated Diarrhea?
Background: Patients on antibiotics experience diarrhea as a side effect 5%-25% of the time, of which C. difficile is the cause in 15%-25% of these cases. Probiotics, such as Streptococcus thermophilus, Enterococcus species, Saccharomyces species, and Lactobacillus species are live microorganisms that can safely be used to treat diarrhea associated with antibiotic use.
Study design: Randomized, double-blind, placebo controlled
Setting: Three London hospitals
Synopsis: The study enrolled 135 hospitalized patients over age 50 who were prescribed antibiotics.
The treatment group received a probiotic yogurt drink containing Lactobacillus casei, L. bulgaricus, and S. thermophilus; the placebo group received a sterile milkshake. Subjects consumed the drinks twice daily within 48 hours of starting antibiotic therapy and continued for one week after antibiotic use.
There was a significant reduction of diarrhea in the probiotic group (p=0.007); the number needed to treat (NNT) was five. There was also a significant decrease in diarrhea caused by C. difficile (p=0.001), the secondary outcome, with an NNT of six.
These results may translate into decreased patient morbidity, mortality, healthcare costs, and length of stay. Additional studies are needed to establish the most effective probiotic and dosing for reducing diarrhea.
Bottom line: Twice-daily consumption of probiotic drinks can decrease the risk of antibiotic-induced diarrhea.
Citation: Hickson M, D’Souza AL, Muthu N, et al. Use of probiotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics: randomized double blind placebo controlled trial. BMJ. 2007 Jul 14;335(7610):80.
What Organisms Commonly Cause Healthcare-Associated Pneumonia in Nonhospitalized Patients?
Background: Changes in practice patterns have resulted in a large number of patients who regularly interact with healthcare but aren’t admitted to the hospital (e.g., those receiving dialysis or home healthcare). These patients develop nosocomial-type infections rather than infections from traditionally community-acquired organisms.
Study design: Prospective observational for three years.
Setting: A large teaching hospital in Barcelona, Spain.
Synopsis: A total of 727 patients were stratified into community-acquired pneumonia (CAP) or healthcare-associated pneumonia (HCAP) groups based on whether they had:
- Received home intravenous therapy;
- Attended a hospital or hemodialysis clinic or had chemotherapy in the preceding 30 days;
- Were admitted to an acute care facility for at least two days in the preceding 90 days; or
- Resided in a nursing home.
The HCAP group tended to be older, have higher comorbidities (particularly cerebrovascular disease or malignancy), have previously received antibiotics, and have higher pneumonia severity indices.
The putative organisms were similar in both groups with Streptococcus pneumoniae representing the most common pathogen. HCAP patients had higher rates of penicillin, erythromycin, and levofloxacin resistance; aspiration pneumonia; longer lengths of stay; and 30-day mortality. Inappropriate therapy occurred more commonly in the HCAP group (5.6% versus 2.0%). Such therapy was defined as the absence of antibiotics targeting suspect pathogens, the use of antibiotics to which the bacteria were not susceptible, or the failure to start anaerobic coverage for aspiration pneumonia.
Bottom line: Outpatients who come in frequent contact with the healthcare system while presenting with pneumonia are more likely to have drug-resistant organisms similar to those seen in nosocomial pneumonia. Further, they tend to have inappropriate or inadequate antimicrobial therapy, longer hospital stays, and increased risk of death.
Citation: Carratalà J, Mykietiuk A, Fernández-Sabe N, et al. Health care-associated pneumonia requiring hospital admission. Arch Intern Med. 2007;167(13):1393-1399. TH
In This Edition
- Treat with antibiotics for seven days or less in adults with community-acquired pneumonia.
- In patients with chronic kidney disease who present with non ST-segment elevation acute coronary syndromes, anticoagulation with fondaparinux (Arixtra) is safer than with enoxaparin (Lovenox).
- Multislice coronary angiography rules out suspected coronary artery disease.
- Hospitalists in teaching hospitals decrease length of stay in complex patients.
- Epoetin alfa (Procrit/Epogen) use in critically ill patients does not reduce red-cell transfusion but may reduce mortality in trauma.
- Newer antibiotics appear to be more effective for acute exacerbations of chronic bronchitis.
- Low-income patients and patients seen by specialists are less likely to use generic medications.
- Hospitalist-orthopedic comanagement of patients with hip fractures does not negatively affect long-term mortality.
- Probiotics reduce antibiotic and C. difficile-associated diarrhea.
- Healthcare-associated pneumonia closely resembles nosocomial pneumonia.
What Is the Appropriate Duration of Antibiotic Therapy for Adults with CAP?
Background: Community-acquired pneumonia (CAP) is a leading cause of morbidity and mortality, but there is little consensus on the appropriate duration of antibiotic therapy. Current guidelines recommend antibiotic regimens lasting from five to 14 days. Shorter courses of antibiotic therapy may improve patient compliance, reduce risk of medication related adverse effects, and minimize the risk of antimicrobial resistance.
Study design: Meta-analysis.
Synopsis: Authors included 15 randomized controlled trials from 1990 through 2004. They compared the efficacy of short-course (seven days or less) antibiotic monotherapy versus extended regimens (longer than seven days) in patients age 12 or older with mild to moderate CAP. They excluded trials with a significant number of patients with bronchitis, healthcare-associated pneumonias, and chronic obstructive pulmonary disease exacerbations. The primary outcome measure failed to achieve clinical improvement or cure. Secondary outcome measures included mortality, bacteriologic failure, and other adverse events.
The authors found no significant differences in the risk of clinical failure, risk of mortality, risk of bacteriologic failure, or risk of adverse events in the short-course versus extended-course antibiotic regimens. This was consistent among the four antibiotic classes in the study: beta-lactam, fluoroquinolone, ketolide, and macrolide.
Bottom line: This study found no differences between short-course and extended-course antibiotic regimens in the treatment of adults with mild to moderate CAP in regard to clinical success, mortality, bacteriologic success, and adverse events.
Citation: Li JZ, Winston LG, Moore DH, et al. Efficacy of short-course antibiotic regimens for CAP: A meta-analysis. Am J Med. 2007;120(9):783-790.
Is Fondaparinux Superior to Enoxaparin in Non-ST-Elevation Acute Coronary Syndromes?
Background: Fondaparinux is a selective factor Xa inhibitor approved by the FDA for the treatment and prevention of venous thromboembolism. The Organization to Assess Strategies for Ischemic Syndromes (OASIS)-5 was a randomized, double-blind trial that demonstrated fondaparinux is similar to enoxaparin in reducing the risk of ischemic events, but substantially reduces major bleeding, long-term mortality, and morbidity.1
Study design: Subgroup analysis of a randomized, controlled trial.
Setting: Hospitals to which patients with non-ST-segment elevation acute coronary syndrome presented.
Synopsis: In a subgroup analysis of 19,979 in the OASIS-5 trial, patients were divided into quartiles based on their estimated creatinine clearance, calculated by using the Modification of Diet in Renal Disease formula.2 Death, myocardial infarction, refractory ischemia, and major bleeding were evaluated separately, and as a composite end point at nine, 30, and 180 days.
At nine days, death, myocardial infarction, or refractory ischemia occurred in 6.7% of patients receiving fondaparinux and 7.4% of those receiving enoxaparin (hazard ratio, 0.90, 95% confidence interval [CI], 0.73 to 1.11); major bleeding occurred in 2.8% and 6.4%, respectively (hazard ratio, 0.42, CI, 0.32 to 0.56). Statistically significant differences in major bleeding persisted at 30 and 180 days.
While there was a trend toward a reduction in the composite end point among all quartiles of glomerular filtration rate (GFR), the differences were statistically significant only among patients with a GFR less than 58 mL/min per 1.73 m2. The authors concluded that the absolute differences in favor of fondaparinux (efficacy and safety) were most apparent in patients with a GFR less than 58 mL/min per 1.73 m2 and were largely the result in a reduction in bleeding events.
The subgroup analysis was not planned before the OASIS-5 data were collected, and the results have not been confirmed elsewhere. For patients managed with an early invasive strategy, catheter thrombosis occurred more often in those who received fondaparinux than enoxaparin alone. Fondaparinux is not FDA approved for this indication.
Bottom line: In patients with chronic kidney disease who present with non ST-segment elevation acute coronary syndromes, anticoagulation with fondaparinux is associated with a significant reduction in the incidence of major bleeding as compared with enoxaparin.
Citations:
- Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med. 2006;354(14):1464-1476.
- Fox KA, Bassand JP, Mehta SR, et al. Influence of renal function on the efficacy and safety of fondaparinux relative to enoxaparin in non ST-segment elevation acute coronary syndromes. Ann Intern Med. 2007;147(5):304-310.
What’s the Prognosis of Asymptomatic Patients with Suspected Coronary Artery Disease with Normal Multislice Angiogram?
Background: Several studies have demonstrated high sensitivity and negative predictive values for computed tomography (CT) coronary angiography.
Study design: Prospective, sequentially enrolled subjects.
Synopsis: A CT angiogram was given to 182 consecutive patients scheduled for conventional coronary angiography without acute coronary syndrome and insufficient coronary calcification to limit CT angiography. Researchers enrolled 141 because CT angiography was inconclusive or warranted actual conventional angiography.
These normal CT angiogram subjects were followed for a mean time of 14.7 months without loss to follow-up or any mortality. Five subsequently underwent conventional angiography eight to 11 months following CT, and three had clinically significant single-vessel disease. The other two had normal conventional angiograms. There was one myocardial infarction patient who, upon further review of CT, had previously unappreciated right-coronary-artery (RCA) disease. This prospective study demonstrated a 97.2% negative predictive value consistent with previous studies. Mortality, myocardial infarction, and subsequently identified coronary artery disease (CAD) are also consistent with previously published data for conventional angiography.
Bottom line: In this small, prospective study, multislice CT coronary angiography safely rules out suspected CAD.
Citation: Gilard M, Le Gal G, Cornily JC, et al. Midterm prognosis of patients with suspected coronary artery disease and normal multislice computer tomographic findings. Arch Intern Med. 2007;165(15):1687-1689.
Does Epoetin Alfa Reduce Need for Blood Transfusion Therapy in Critically Ill Patients?
Background: Two prior studies demonstrated that the use of epoetin reduced the number of red-cell transfusions in ICU patients without any other clinical benefits. There were possible subgroup differences between trauma and nontrauma patients. This study assessed a reduced dose of epoetin alfa and evaluated clinical outcomes and subgroup differences suggested by the previous studies.
Study design: Prospective, randomized, double-blind, placebo-controlled clinical trial.
Setting: 115 medical centers.
Synopsis: The study group of 1,460 patients underwent stratified randomization into trauma, surgical nontrauma, and medical nontrauma groups. There were no significant differences in transfusion requirements between the epoetin group, the placebo group, or in any subgroup. The mean pre-transfusion hemoglobin was the same in each group.
The epoetin group had a higher-than-baseline hemoglobin level at day 29 (1.6 versus 1.2 g/dL, p<0.001) and a higher absolute hemoglobin (11.2 versus 10.8 g/dL, p<0.001) than the placebo group. Mortality was lower in the epoetin group (8.5% versus 11.4%, p=0.02) and in the trauma subgroup (3.5% versus 6.6%, p=0.04). In two nontrauma groups, point estimates demonstrated similar lower mortality but were not statistically significant.
Thrombotic vascular events were higher in the epoetin group than the placebo group (16.5% versus 11.5%, p=0.008), but post-hoc analyses demonstrated that the effect was only observed in patients who had not received heparin at baseline. There were no other observed differences in length of stay or use of mechanical ventilation.
Bottom line: Epoetin alfa does not reduce red blood cell transfusions in ICU patients but may reduce mortality in trauma patients. Increased thrombotic events may be mitigated with the use of heparin.
Citation: Corwin HL, Gettinger A, Fabian TC, et al. Efficacy and safety of epoetin alfa in critically ill patients. N Engl J Med. 2007;357 (10):965-976.
What Patients Benefit Most from Hospitalist Care in an Academic Medical Center?
Background: Hospitalists increasingly serve as teaching attending physicians at many academic medical centers. Studies have shown hospitalists’ care can reduce the length of hospital stay in patients with a limited number of specific diagnoses. It has not been established whether there are other specific patient diagnoses or discharge dispositions that might benefit from hospitalist care in a teaching hospital.
Study design: Retrospective cohort.
Setting: Urban teaching hospital.
Synopsis: The authors examined the patients discharged from a hospitalist and a non-hospitalist teaching attending service at an academic medical center during a two-year period beginning July 1, 2002. The length of hospital stay for patients on the hospitalist teaching attending service was significantly lower than that of the non-hospitalist teaching attending service. This difference was most pronounced in patients with highest overall acuity as measured by diagnosis-related group (DRG) weight and patients who required discharge to nursing facilities.
Bottom line: Medically complex inpatients and inpatients with complex discharge planning needs appear to have a shorter length of hospital stay when under the care of hospitalists serving as teaching attending physicians compared with non-hospitalist teaching attending physicians.
Citation: Southern WN, Berger MA, Bellin EY, et al. Hospitalist care and length of stay in patients requiring complex discharge planning and close clinical monitoring. Arch Intern Med. 2007;167(17):1869-1874.
What Influences Use of Generic, Branded Medications?
Background: Expenditures for prescription medications exceeded $250 billion in 2005. Various patient, physician, and payment factors may increase generic drug use in an attempt to reduce costs without affecting quality of care.
Study design: Observational analysis.
Synopsis: This study analyzed initial and subsequent pharmacy claims for 5,399 patients enrolled in a large health plan in the western United States, from 2001-2003. For new prescriptions, 23% were generics. Initiation of generic medications was less likely for patients in poor neighborhoods and for prescriptions written by specialists; pharmacy benefit design and pharmacy type did not have a significant influence.
After initiation of branded medications, 15% switched to generics during the study follow-up. Patients were more likely to switch to generic medications if they were older, if they used mail-order pharmacies, or if they participated in multitier (three or more) co-payment plans.
Bottom line: Low-income patients and patients who see specialists are less likely to initiate generic medications; after initiation on branded medications, patients using mail-order pharmacies or multitier co-payment systems are more likely to switch to generics.
Citation: Shrank WH, Stedman M, Ettner SL, et al. Patient, physician, pharmacy, and pharmacy benefit design factors related to generic medication use. J Gen Intern Med. 2007; 22:1298-1304.
Does Orthopedic Comanagement Increase Mortality in Elderly Hip Fracture Patients?
Background: Prior studies have demonstrated that for patients with hip fracture, a hospitalist-orthopedic comanagement management service reduced time to surgery and length of stay, with no difference in inpatient mortality. This study sought to address whether this applied to long-term mortality as well.
Study design: Retrospective cohort study.
Setting: Tertiary care center.
Synopsis: This study examined 466 patients admitted consecutively to a tertiary care center for surgical repair of a hip fracture, and followed them for one year postoperatively. It compared outcomes for patients admitted to a hospitalist-orthopedic comanagement service (2001-2002) with a standard care group of historical controls admitted to either an orthopedic or general medical teaching service (2000-2001).
One-year survival did not differ between the patients on the hospitalist-orthopedic comanagement service (70.5%) versus those in the standard care group (70.6%). The hospitalist-orthopedic comanagement model was associated with shorter time to surgery and shorter length of stay (8.4 versus 10.6 days). According to multivariate analysis, independent predictors of mortality were: American Society of Anesthesiologists (ASA) class III or IV (hazard ratio 4.2, 95% CI, 2.21, 7.99), admission from a nursing home (hazard ratio 2.24, 95% CI, 1.73, 2.90), and inpatient complications such as renal failure, myocardial infarction, or ICU admission (hazard ratio 1.85, CI 95%, 1.45, 2.35).
The authors note that prior studies demonstrated benefits from hospitalist involvement only after one year of implementation. This study was performed during the first year of the hospitalist-orthopedic comanagement team.
Bottom line: Hospitalist-orthopedic comanagement of patients with hip fracture reduces length of stay and does not negatively affect long-term mortality.
Citation: Batsis JA, Phy MP, Melton LJ, et al. Effects of a hospitalist care model on mortality of elderly patients with hip fractures. J Hosp Med. 2007;2:219-225.
How Effective Are First-Line, Second-Line Antibiotics for AECB?
Background: Antibiotics are frequently used for treatment of acute exacerbations of chronic bronchitis (AECB). However, in this era of increasing microbial resistance, there are insufficient data comparing the efficacy and safety of first-line antibiotics (ampicillin, amoxicillin, doxycycline, trimethoprim-sulfamethoxazole [Bactrim, Cotrima, Septra]) with second-line antibiotics (amoxicillin-clavulanic acid [Augmentin], macrolides, second- and third-generation cephalosporins, and fluoroquinolones).
Study design: Meta-analysis of randomized controlled trials (RCT).
Synopsis: Authors included 12 RCTs from 1981 to 2000, enrolling 2,261 adult patients comparing the efficacy and toxicity of first-line with second-line antibiotics for AECB in inpatient and outpatient settings. The authors measured treatment success, drug-related adverse events, all-cause mortality and pathogen eradication.
They concluded that administration of first-line antibiotics was associated with lower treatment success than administration of second-line antibiotics (odd ratio [OR] 0.51, 95% CI, 0.34 to 0.75). However, no differences were found with regard to all-cause mortality (OR 0.64, 95% CI, 0.25 to 3.35), adverse effects (OR 0.75, 95% CI, 0.39 to 1.45), or treatment success in microbiologically evaluable patients (OR 0.56, 95% CI, 0.22 to 1.43). Some limitations of this meta-analysis include:
- Inadequate data to stratify patients according to risk factors for poor outcome;
- Trials included inpatients as well as outpatients (likely with varying disease severity); and
- Trials were conducted in different time periods with changing patterns of anti-microbial resistance.
Bottom line: In patients with AECB, second-line antibiotics are more effective than first-line antibiotics with no differences in safety or mortality.
Citation: Dimopoulos G, Siempos II, Korbila IP, et al. Comparison of first-line with second-line antibiotics for acute exacerbations of chronic bronchitis. Chest. 2007;132:447-455.
Do Probiotic Drinks Reduce Antibiotic-Associated Diarrhea?
Background: Patients on antibiotics experience diarrhea as a side effect 5%-25% of the time, of which C. difficile is the cause in 15%-25% of these cases. Probiotics, such as Streptococcus thermophilus, Enterococcus species, Saccharomyces species, and Lactobacillus species are live microorganisms that can safely be used to treat diarrhea associated with antibiotic use.
Study design: Randomized, double-blind, placebo controlled
Setting: Three London hospitals
Synopsis: The study enrolled 135 hospitalized patients over age 50 who were prescribed antibiotics.
The treatment group received a probiotic yogurt drink containing Lactobacillus casei, L. bulgaricus, and S. thermophilus; the placebo group received a sterile milkshake. Subjects consumed the drinks twice daily within 48 hours of starting antibiotic therapy and continued for one week after antibiotic use.
There was a significant reduction of diarrhea in the probiotic group (p=0.007); the number needed to treat (NNT) was five. There was also a significant decrease in diarrhea caused by C. difficile (p=0.001), the secondary outcome, with an NNT of six.
These results may translate into decreased patient morbidity, mortality, healthcare costs, and length of stay. Additional studies are needed to establish the most effective probiotic and dosing for reducing diarrhea.
Bottom line: Twice-daily consumption of probiotic drinks can decrease the risk of antibiotic-induced diarrhea.
Citation: Hickson M, D’Souza AL, Muthu N, et al. Use of probiotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics: randomized double blind placebo controlled trial. BMJ. 2007 Jul 14;335(7610):80.
What Organisms Commonly Cause Healthcare-Associated Pneumonia in Nonhospitalized Patients?
Background: Changes in practice patterns have resulted in a large number of patients who regularly interact with healthcare but aren’t admitted to the hospital (e.g., those receiving dialysis or home healthcare). These patients develop nosocomial-type infections rather than infections from traditionally community-acquired organisms.
Study design: Prospective observational for three years.
Setting: A large teaching hospital in Barcelona, Spain.
Synopsis: A total of 727 patients were stratified into community-acquired pneumonia (CAP) or healthcare-associated pneumonia (HCAP) groups based on whether they had:
- Received home intravenous therapy;
- Attended a hospital or hemodialysis clinic or had chemotherapy in the preceding 30 days;
- Were admitted to an acute care facility for at least two days in the preceding 90 days; or
- Resided in a nursing home.
The HCAP group tended to be older, have higher comorbidities (particularly cerebrovascular disease or malignancy), have previously received antibiotics, and have higher pneumonia severity indices.
The putative organisms were similar in both groups with Streptococcus pneumoniae representing the most common pathogen. HCAP patients had higher rates of penicillin, erythromycin, and levofloxacin resistance; aspiration pneumonia; longer lengths of stay; and 30-day mortality. Inappropriate therapy occurred more commonly in the HCAP group (5.6% versus 2.0%). Such therapy was defined as the absence of antibiotics targeting suspect pathogens, the use of antibiotics to which the bacteria were not susceptible, or the failure to start anaerobic coverage for aspiration pneumonia.
Bottom line: Outpatients who come in frequent contact with the healthcare system while presenting with pneumonia are more likely to have drug-resistant organisms similar to those seen in nosocomial pneumonia. Further, they tend to have inappropriate or inadequate antimicrobial therapy, longer hospital stays, and increased risk of death.
Citation: Carratalà J, Mykietiuk A, Fernández-Sabe N, et al. Health care-associated pneumonia requiring hospital admission. Arch Intern Med. 2007;167(13):1393-1399. TH
In This Edition
- Treat with antibiotics for seven days or less in adults with community-acquired pneumonia.
- In patients with chronic kidney disease who present with non ST-segment elevation acute coronary syndromes, anticoagulation with fondaparinux (Arixtra) is safer than with enoxaparin (Lovenox).
- Multislice coronary angiography rules out suspected coronary artery disease.
- Hospitalists in teaching hospitals decrease length of stay in complex patients.
- Epoetin alfa (Procrit/Epogen) use in critically ill patients does not reduce red-cell transfusion but may reduce mortality in trauma.
- Newer antibiotics appear to be more effective for acute exacerbations of chronic bronchitis.
- Low-income patients and patients seen by specialists are less likely to use generic medications.
- Hospitalist-orthopedic comanagement of patients with hip fractures does not negatively affect long-term mortality.
- Probiotics reduce antibiotic and C. difficile-associated diarrhea.
- Healthcare-associated pneumonia closely resembles nosocomial pneumonia.
What Is the Appropriate Duration of Antibiotic Therapy for Adults with CAP?
Background: Community-acquired pneumonia (CAP) is a leading cause of morbidity and mortality, but there is little consensus on the appropriate duration of antibiotic therapy. Current guidelines recommend antibiotic regimens lasting from five to 14 days. Shorter courses of antibiotic therapy may improve patient compliance, reduce risk of medication related adverse effects, and minimize the risk of antimicrobial resistance.
Study design: Meta-analysis.
Synopsis: Authors included 15 randomized controlled trials from 1990 through 2004. They compared the efficacy of short-course (seven days or less) antibiotic monotherapy versus extended regimens (longer than seven days) in patients age 12 or older with mild to moderate CAP. They excluded trials with a significant number of patients with bronchitis, healthcare-associated pneumonias, and chronic obstructive pulmonary disease exacerbations. The primary outcome measure failed to achieve clinical improvement or cure. Secondary outcome measures included mortality, bacteriologic failure, and other adverse events.
The authors found no significant differences in the risk of clinical failure, risk of mortality, risk of bacteriologic failure, or risk of adverse events in the short-course versus extended-course antibiotic regimens. This was consistent among the four antibiotic classes in the study: beta-lactam, fluoroquinolone, ketolide, and macrolide.
Bottom line: This study found no differences between short-course and extended-course antibiotic regimens in the treatment of adults with mild to moderate CAP in regard to clinical success, mortality, bacteriologic success, and adverse events.
Citation: Li JZ, Winston LG, Moore DH, et al. Efficacy of short-course antibiotic regimens for CAP: A meta-analysis. Am J Med. 2007;120(9):783-790.
Is Fondaparinux Superior to Enoxaparin in Non-ST-Elevation Acute Coronary Syndromes?
Background: Fondaparinux is a selective factor Xa inhibitor approved by the FDA for the treatment and prevention of venous thromboembolism. The Organization to Assess Strategies for Ischemic Syndromes (OASIS)-5 was a randomized, double-blind trial that demonstrated fondaparinux is similar to enoxaparin in reducing the risk of ischemic events, but substantially reduces major bleeding, long-term mortality, and morbidity.1
Study design: Subgroup analysis of a randomized, controlled trial.
Setting: Hospitals to which patients with non-ST-segment elevation acute coronary syndrome presented.
Synopsis: In a subgroup analysis of 19,979 in the OASIS-5 trial, patients were divided into quartiles based on their estimated creatinine clearance, calculated by using the Modification of Diet in Renal Disease formula.2 Death, myocardial infarction, refractory ischemia, and major bleeding were evaluated separately, and as a composite end point at nine, 30, and 180 days.
At nine days, death, myocardial infarction, or refractory ischemia occurred in 6.7% of patients receiving fondaparinux and 7.4% of those receiving enoxaparin (hazard ratio, 0.90, 95% confidence interval [CI], 0.73 to 1.11); major bleeding occurred in 2.8% and 6.4%, respectively (hazard ratio, 0.42, CI, 0.32 to 0.56). Statistically significant differences in major bleeding persisted at 30 and 180 days.
While there was a trend toward a reduction in the composite end point among all quartiles of glomerular filtration rate (GFR), the differences were statistically significant only among patients with a GFR less than 58 mL/min per 1.73 m2. The authors concluded that the absolute differences in favor of fondaparinux (efficacy and safety) were most apparent in patients with a GFR less than 58 mL/min per 1.73 m2 and were largely the result in a reduction in bleeding events.
The subgroup analysis was not planned before the OASIS-5 data were collected, and the results have not been confirmed elsewhere. For patients managed with an early invasive strategy, catheter thrombosis occurred more often in those who received fondaparinux than enoxaparin alone. Fondaparinux is not FDA approved for this indication.
Bottom line: In patients with chronic kidney disease who present with non ST-segment elevation acute coronary syndromes, anticoagulation with fondaparinux is associated with a significant reduction in the incidence of major bleeding as compared with enoxaparin.
Citations:
- Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med. 2006;354(14):1464-1476.
- Fox KA, Bassand JP, Mehta SR, et al. Influence of renal function on the efficacy and safety of fondaparinux relative to enoxaparin in non ST-segment elevation acute coronary syndromes. Ann Intern Med. 2007;147(5):304-310.
What’s the Prognosis of Asymptomatic Patients with Suspected Coronary Artery Disease with Normal Multislice Angiogram?
Background: Several studies have demonstrated high sensitivity and negative predictive values for computed tomography (CT) coronary angiography.
Study design: Prospective, sequentially enrolled subjects.
Synopsis: A CT angiogram was given to 182 consecutive patients scheduled for conventional coronary angiography without acute coronary syndrome and insufficient coronary calcification to limit CT angiography. Researchers enrolled 141 because CT angiography was inconclusive or warranted actual conventional angiography.
These normal CT angiogram subjects were followed for a mean time of 14.7 months without loss to follow-up or any mortality. Five subsequently underwent conventional angiography eight to 11 months following CT, and three had clinically significant single-vessel disease. The other two had normal conventional angiograms. There was one myocardial infarction patient who, upon further review of CT, had previously unappreciated right-coronary-artery (RCA) disease. This prospective study demonstrated a 97.2% negative predictive value consistent with previous studies. Mortality, myocardial infarction, and subsequently identified coronary artery disease (CAD) are also consistent with previously published data for conventional angiography.
Bottom line: In this small, prospective study, multislice CT coronary angiography safely rules out suspected CAD.
Citation: Gilard M, Le Gal G, Cornily JC, et al. Midterm prognosis of patients with suspected coronary artery disease and normal multislice computer tomographic findings. Arch Intern Med. 2007;165(15):1687-1689.
Does Epoetin Alfa Reduce Need for Blood Transfusion Therapy in Critically Ill Patients?
Background: Two prior studies demonstrated that the use of epoetin reduced the number of red-cell transfusions in ICU patients without any other clinical benefits. There were possible subgroup differences between trauma and nontrauma patients. This study assessed a reduced dose of epoetin alfa and evaluated clinical outcomes and subgroup differences suggested by the previous studies.
Study design: Prospective, randomized, double-blind, placebo-controlled clinical trial.
Setting: 115 medical centers.
Synopsis: The study group of 1,460 patients underwent stratified randomization into trauma, surgical nontrauma, and medical nontrauma groups. There were no significant differences in transfusion requirements between the epoetin group, the placebo group, or in any subgroup. The mean pre-transfusion hemoglobin was the same in each group.
The epoetin group had a higher-than-baseline hemoglobin level at day 29 (1.6 versus 1.2 g/dL, p<0.001) and a higher absolute hemoglobin (11.2 versus 10.8 g/dL, p<0.001) than the placebo group. Mortality was lower in the epoetin group (8.5% versus 11.4%, p=0.02) and in the trauma subgroup (3.5% versus 6.6%, p=0.04). In two nontrauma groups, point estimates demonstrated similar lower mortality but were not statistically significant.
Thrombotic vascular events were higher in the epoetin group than the placebo group (16.5% versus 11.5%, p=0.008), but post-hoc analyses demonstrated that the effect was only observed in patients who had not received heparin at baseline. There were no other observed differences in length of stay or use of mechanical ventilation.
Bottom line: Epoetin alfa does not reduce red blood cell transfusions in ICU patients but may reduce mortality in trauma patients. Increased thrombotic events may be mitigated with the use of heparin.
Citation: Corwin HL, Gettinger A, Fabian TC, et al. Efficacy and safety of epoetin alfa in critically ill patients. N Engl J Med. 2007;357 (10):965-976.
What Patients Benefit Most from Hospitalist Care in an Academic Medical Center?
Background: Hospitalists increasingly serve as teaching attending physicians at many academic medical centers. Studies have shown hospitalists’ care can reduce the length of hospital stay in patients with a limited number of specific diagnoses. It has not been established whether there are other specific patient diagnoses or discharge dispositions that might benefit from hospitalist care in a teaching hospital.
Study design: Retrospective cohort.
Setting: Urban teaching hospital.
Synopsis: The authors examined the patients discharged from a hospitalist and a non-hospitalist teaching attending service at an academic medical center during a two-year period beginning July 1, 2002. The length of hospital stay for patients on the hospitalist teaching attending service was significantly lower than that of the non-hospitalist teaching attending service. This difference was most pronounced in patients with highest overall acuity as measured by diagnosis-related group (DRG) weight and patients who required discharge to nursing facilities.
Bottom line: Medically complex inpatients and inpatients with complex discharge planning needs appear to have a shorter length of hospital stay when under the care of hospitalists serving as teaching attending physicians compared with non-hospitalist teaching attending physicians.
Citation: Southern WN, Berger MA, Bellin EY, et al. Hospitalist care and length of stay in patients requiring complex discharge planning and close clinical monitoring. Arch Intern Med. 2007;167(17):1869-1874.
What Influences Use of Generic, Branded Medications?
Background: Expenditures for prescription medications exceeded $250 billion in 2005. Various patient, physician, and payment factors may increase generic drug use in an attempt to reduce costs without affecting quality of care.
Study design: Observational analysis.
Synopsis: This study analyzed initial and subsequent pharmacy claims for 5,399 patients enrolled in a large health plan in the western United States, from 2001-2003. For new prescriptions, 23% were generics. Initiation of generic medications was less likely for patients in poor neighborhoods and for prescriptions written by specialists; pharmacy benefit design and pharmacy type did not have a significant influence.
After initiation of branded medications, 15% switched to generics during the study follow-up. Patients were more likely to switch to generic medications if they were older, if they used mail-order pharmacies, or if they participated in multitier (three or more) co-payment plans.
Bottom line: Low-income patients and patients who see specialists are less likely to initiate generic medications; after initiation on branded medications, patients using mail-order pharmacies or multitier co-payment systems are more likely to switch to generics.
Citation: Shrank WH, Stedman M, Ettner SL, et al. Patient, physician, pharmacy, and pharmacy benefit design factors related to generic medication use. J Gen Intern Med. 2007; 22:1298-1304.
Does Orthopedic Comanagement Increase Mortality in Elderly Hip Fracture Patients?
Background: Prior studies have demonstrated that for patients with hip fracture, a hospitalist-orthopedic comanagement management service reduced time to surgery and length of stay, with no difference in inpatient mortality. This study sought to address whether this applied to long-term mortality as well.
Study design: Retrospective cohort study.
Setting: Tertiary care center.
Synopsis: This study examined 466 patients admitted consecutively to a tertiary care center for surgical repair of a hip fracture, and followed them for one year postoperatively. It compared outcomes for patients admitted to a hospitalist-orthopedic comanagement service (2001-2002) with a standard care group of historical controls admitted to either an orthopedic or general medical teaching service (2000-2001).
One-year survival did not differ between the patients on the hospitalist-orthopedic comanagement service (70.5%) versus those in the standard care group (70.6%). The hospitalist-orthopedic comanagement model was associated with shorter time to surgery and shorter length of stay (8.4 versus 10.6 days). According to multivariate analysis, independent predictors of mortality were: American Society of Anesthesiologists (ASA) class III or IV (hazard ratio 4.2, 95% CI, 2.21, 7.99), admission from a nursing home (hazard ratio 2.24, 95% CI, 1.73, 2.90), and inpatient complications such as renal failure, myocardial infarction, or ICU admission (hazard ratio 1.85, CI 95%, 1.45, 2.35).
The authors note that prior studies demonstrated benefits from hospitalist involvement only after one year of implementation. This study was performed during the first year of the hospitalist-orthopedic comanagement team.
Bottom line: Hospitalist-orthopedic comanagement of patients with hip fracture reduces length of stay and does not negatively affect long-term mortality.
Citation: Batsis JA, Phy MP, Melton LJ, et al. Effects of a hospitalist care model on mortality of elderly patients with hip fractures. J Hosp Med. 2007;2:219-225.
How Effective Are First-Line, Second-Line Antibiotics for AECB?
Background: Antibiotics are frequently used for treatment of acute exacerbations of chronic bronchitis (AECB). However, in this era of increasing microbial resistance, there are insufficient data comparing the efficacy and safety of first-line antibiotics (ampicillin, amoxicillin, doxycycline, trimethoprim-sulfamethoxazole [Bactrim, Cotrima, Septra]) with second-line antibiotics (amoxicillin-clavulanic acid [Augmentin], macrolides, second- and third-generation cephalosporins, and fluoroquinolones).
Study design: Meta-analysis of randomized controlled trials (RCT).
Synopsis: Authors included 12 RCTs from 1981 to 2000, enrolling 2,261 adult patients comparing the efficacy and toxicity of first-line with second-line antibiotics for AECB in inpatient and outpatient settings. The authors measured treatment success, drug-related adverse events, all-cause mortality and pathogen eradication.
They concluded that administration of first-line antibiotics was associated with lower treatment success than administration of second-line antibiotics (odd ratio [OR] 0.51, 95% CI, 0.34 to 0.75). However, no differences were found with regard to all-cause mortality (OR 0.64, 95% CI, 0.25 to 3.35), adverse effects (OR 0.75, 95% CI, 0.39 to 1.45), or treatment success in microbiologically evaluable patients (OR 0.56, 95% CI, 0.22 to 1.43). Some limitations of this meta-analysis include:
- Inadequate data to stratify patients according to risk factors for poor outcome;
- Trials included inpatients as well as outpatients (likely with varying disease severity); and
- Trials were conducted in different time periods with changing patterns of anti-microbial resistance.
Bottom line: In patients with AECB, second-line antibiotics are more effective than first-line antibiotics with no differences in safety or mortality.
Citation: Dimopoulos G, Siempos II, Korbila IP, et al. Comparison of first-line with second-line antibiotics for acute exacerbations of chronic bronchitis. Chest. 2007;132:447-455.
Do Probiotic Drinks Reduce Antibiotic-Associated Diarrhea?
Background: Patients on antibiotics experience diarrhea as a side effect 5%-25% of the time, of which C. difficile is the cause in 15%-25% of these cases. Probiotics, such as Streptococcus thermophilus, Enterococcus species, Saccharomyces species, and Lactobacillus species are live microorganisms that can safely be used to treat diarrhea associated with antibiotic use.
Study design: Randomized, double-blind, placebo controlled
Setting: Three London hospitals
Synopsis: The study enrolled 135 hospitalized patients over age 50 who were prescribed antibiotics.
The treatment group received a probiotic yogurt drink containing Lactobacillus casei, L. bulgaricus, and S. thermophilus; the placebo group received a sterile milkshake. Subjects consumed the drinks twice daily within 48 hours of starting antibiotic therapy and continued for one week after antibiotic use.
There was a significant reduction of diarrhea in the probiotic group (p=0.007); the number needed to treat (NNT) was five. There was also a significant decrease in diarrhea caused by C. difficile (p=0.001), the secondary outcome, with an NNT of six.
These results may translate into decreased patient morbidity, mortality, healthcare costs, and length of stay. Additional studies are needed to establish the most effective probiotic and dosing for reducing diarrhea.
Bottom line: Twice-daily consumption of probiotic drinks can decrease the risk of antibiotic-induced diarrhea.
Citation: Hickson M, D’Souza AL, Muthu N, et al. Use of probiotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics: randomized double blind placebo controlled trial. BMJ. 2007 Jul 14;335(7610):80.
What Organisms Commonly Cause Healthcare-Associated Pneumonia in Nonhospitalized Patients?
Background: Changes in practice patterns have resulted in a large number of patients who regularly interact with healthcare but aren’t admitted to the hospital (e.g., those receiving dialysis or home healthcare). These patients develop nosocomial-type infections rather than infections from traditionally community-acquired organisms.
Study design: Prospective observational for three years.
Setting: A large teaching hospital in Barcelona, Spain.
Synopsis: A total of 727 patients were stratified into community-acquired pneumonia (CAP) or healthcare-associated pneumonia (HCAP) groups based on whether they had:
- Received home intravenous therapy;
- Attended a hospital or hemodialysis clinic or had chemotherapy in the preceding 30 days;
- Were admitted to an acute care facility for at least two days in the preceding 90 days; or
- Resided in a nursing home.
The HCAP group tended to be older, have higher comorbidities (particularly cerebrovascular disease or malignancy), have previously received antibiotics, and have higher pneumonia severity indices.
The putative organisms were similar in both groups with Streptococcus pneumoniae representing the most common pathogen. HCAP patients had higher rates of penicillin, erythromycin, and levofloxacin resistance; aspiration pneumonia; longer lengths of stay; and 30-day mortality. Inappropriate therapy occurred more commonly in the HCAP group (5.6% versus 2.0%). Such therapy was defined as the absence of antibiotics targeting suspect pathogens, the use of antibiotics to which the bacteria were not susceptible, or the failure to start anaerobic coverage for aspiration pneumonia.
Bottom line: Outpatients who come in frequent contact with the healthcare system while presenting with pneumonia are more likely to have drug-resistant organisms similar to those seen in nosocomial pneumonia. Further, they tend to have inappropriate or inadequate antimicrobial therapy, longer hospital stays, and increased risk of death.
Citation: Carratalà J, Mykietiuk A, Fernández-Sabe N, et al. Health care-associated pneumonia requiring hospital admission. Arch Intern Med. 2007;167(13):1393-1399. TH
In the Literature
Coronary-Artery Revascularization Before Elective Major Vascular Sugery
McFalls EO, Ward HB, Moritz TE, et al. Coronary-artery revascularization before elective major vascular surgery. N Engl J Med. 2004;351:2861-3.
Cardiac risk stratification and treatment prior to non-cardiac surgery is a frequent reason for medical consultation, and yet the optimal approach to managing these patients remains controversial. National guidelines, based on expert opinion and inferred from published data, suggest that preoperative cardiac revascularization be reserved for patients with unstable coronary syndromes or for whom coronary artery bypass grad ing has been shown to improve mortality. Despite these recommendations, there remains considerable variability in clinical practice, which is compounded by a paucity of prospective randomized trials to validate one approach over another.
In this multicenter randomized controlled trial, McFalls et al. studied whether coronary artery revascularization prior to elective vascular surgery would reduce mortality among a cohort of patients with angiographically documented stable coronary artery disease. The investigators evaluated 5859 patients from 18 centers scheduled for abdominal aortic aneurysm or lower extremity vascular surgery. Patients felt to be at high risk for perioperative cardiac complications based on cardiology consultation, established clinical criteria, or the presence of ischemia on stress imaging studies were referred for coronary angiography. Of this cohort, 4669 (80%) were excluded due to subsequent determination of insufficient cardiac risk (28%), urgent need for vascular surgery (18%), severe comorbid illness (13%), patient preference (11%), or prior revascularization without new ischemia (11%). Of the 1190 patients who underwent angiography, 680 were excluded due to protocol criteria including: the absence of obstructive coronary artery disease (54%), coronary disease not amenable to revascularization (32%), led main artery stenosis ≥ 50% (8%), led ventricular ejection fraction <20% (2%), or severe aortic stenosis (AVA<1.0 cm2) (1%).
Of the 510 patients who remained, 252 were randomized to proceed with vascular surgery with optimal medical management, of which 9 crossed over due to the need for urgent cardiac revascularization. Two hundred fifty-eight patients were randomized to elective preoperative revascularization; 99 underwent CABG, 141 underwent PCI, and 18 were excluded due to need for urgent vascular surgery, patient preference, or in one case, stroke. Both groups were similar with respect to baseline clinical variables, including the incidence of previous myocardial infarction, congestive heart failure, diabetes mellitus, led ventricular ejection fraction, and 3vessel coronary artery disease. They were also similar in the use of perioperative betablockers (~ 85%), statins, and aspirin.
At 2.7 years after randomization, mortality was 22% in the revascularization group and 22% in the medical management group, the relative risk was 0.98 (95% CI 0.7-1.37; p=.92), which was not statistically significant. The median time from randomization to vascular surgery was 54 days in the revascularization group and 18 days in the medical management group not undergoing revascularization (p<.001). Although not designed to address short-term outcomes, there were no differences in the rates of early postoperative myocardial infarction, death, or hospital length of stay. It is also worth noting that 316 of the 510 patients who were ultimately randomized had undergone nuclear imaging studies, of which 226 (72%) had moderate to large reversible perfusion defects detected. These outcome data suggest that the presence of reversible perfusions defects is not in itself a reason for preoperative revascularization.
This well-designed study demonstrates that in the absence of unstable coronary syndromes, led main disease, severe aortic stenosis, or severely depressed led ventricular ejection fraction, there is no morbidity or mortality benefit to revascularization among patients with stable coronary artery disease prior to vascular surgery. Because vascular surgery is the highest risk category among non-cardiac procedures, it may be reasonable to extend these findings to lower risk surgeries as well, and in this sense this study is particularly relevant to consultative practice. While this study provides clear evidence on how to manage this cohort of patients, it remains unclear what the optimal strategy is to identify and manage those patients who were excluded from the trial. (DF)
Amiodarone or a Implantable Cardioverter-Defibrilator for Congestive Heart Failure
Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 20;352:225-37.
Ventricular arrhythmias are the leading cause of sudden cardiac death in patients with systolic heart failure. Treatment with antiarrhythmic drug therapy has failed to improve survival in these patients, due to their proarrhythmic effects. Unlike other antiarrhythmics, amiodarone is a drug with low proarrhythmic effects. Some studies have suggested that amiodarone may be beneficial in patients with systolic heart failure. Conversely, several primary and secondary prevention trials have demonstrated that placement of an implantable cardioverter-defibrillator (ICD) confers a survival benefit in patients with ischemic cardiomyopathy. However, the role of ICDs in nonischemic heart failure remained unproven.
Bardy and colleagues developed the Sudden Cardiac Death in Heart Failure Trial (SCDHeFT) to evaluate the hypothesis that treatment with amiodarone or a shock-only, single-lead ICD would decrease death from any cause in a population of patients with mild to moderate heart failure. They randomly assigned 2521 patients with New York Heart Association (NYHA) class II or II heart failure (and a led ventricular ejection fraction (LVEF) of 35% or less to conventional medical therapy plus placebo, conventional therapy plus treatment with amiodarone or conventional therapy plus a conservatively programmed, shock-only, single-lead ICD.
Fifty-two percent of patients had ischemic heart failure and 48% had nonischemic heart failure. Placebo and amiodarone were given in double-blind fashion. The primary endpoint was death from any cause with a median followup of 45.5 months. The results were as follows:
Placebo Group - 244 deaths (29% Death Rate)
Amiodarone Group - 240 deaths (28% Death Rate)
ICD Group - 182 deaths (22% Death Rate)
Patients treated with amiodarone had a similar risk of death as those who received placebo (hazard ratio, 1.06; 97.5% CI: 0.86–1.30; p=0.53). Patients implanted with an ICD had a 23% decreased risk of death when compared with those who received placebo (0.77; 97.5% CI: 0.62–0.96; p=.007). This resulted in an absolute risk reduction of 7.2% at 5 years. The authors concluded that in patients with NYHA class II or III heart failure and a LVEF of 35% or less, implantation of a single-lead, shock-only ICD reduced overall mortality by 23%, while treatment with amiodarone had no effect on survival. The benefit of ICD placement reached or approached significance in both the ischemic (hazard ratio .79, CI: 0.60–1.04, p= .05) and nonischemic (hazard ratio 0.73, CI: 0.50–1.07, p= 0.06) subgroups.
It is important to note that an additional subgroup analysis showed that ICD therapy had a significant survival benefit only in NYHA class II patients but not in NYHA class III patients. Amiodarone therapy had no benefit in class II patients and actually decreased survival in class III patients compared to those receiving placebo. In light of results from previous trials that demonstrated a greater survival benefit from ICD placement with worsening ejection fraction in patients with ischemic heart failure, the authors were unable to explain whether the differences in subclasses were biologically plausible.
This study is important for several reasons. First, it suggested that patients with systolic heart failure due to either ischemic or non ischemic causes would benefit from placement of an ICD. Second, these results support the conclusions of previous trials that demonstrate a survival advantage of ICD placement in patients with ischemic heart failure. Finally, this study also demonstrates that amiodarone therapy offers no survival benefit in this population of patients. (JL)
Clopidogrel versus Aspirin and Esomeprazole to Prevent Recurrent Ulcer Bleeding
Chan F, Ching J, Hung L, et al. Clopidogrel versus aspirin and esomeprazole to prevent recurrent ulcer bleeding. N Engl J Med. 2005;352:238-44.
The optimal choice of antiplatelet therapy for patients with coronary heart disease who have had a recent upper gastrointestinal hemorrhage has not been well studied. Clopidogrel has been shown to cause fewer episodes of gastrointestinal hemorrhage than aspirin, but it is unknown whether clopidogrel monotherapy is in fact superior to aspirin plus a protonpump inhibitor. In this prospective, randomized, doubleblind trial, Chan and colleagues hypothesize that clopidogrel monotherapy would “not be inferior” to aspirin plus esomeprazole in a population of patients who had recovered from aspirin-induced hemorrhagic ulcers.
The study population was drawn from patients taking aspirin who were evaluated for an upper gastrointestinal bleed and had ulcer disease documented on endoscopy. Patients with documented Helicobacter pylori infection were treated with a 1-week course of a standard triple-drug regimen. All subjects, regardless of H. pylori status, were treated with an 8-week course of proton-pump inhibitors (PPI). Inclusion criteria included endoscopic confirmation of ulcer healing and successful eradication of H. pylori, if it was present. The location of the ulcers was not specified in the study.
Exclusion criteria included use of nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 inhibitors, anticoagulant drugs, corticosteroids, or other anti-platelet agents; history of gastric surgery; presence of erosive esophagitis; gastric outlet obstruction; cancer; need for dialysis; or terminal illness.
Subjects who met the inclusion criteria were randomized to receive either 75 mg of clopidogrel and placebo or 80 mg of aspirin daily plus 20 mg of esomeprazole twice a day for a 12 months. Patients returned for evaluation every 3 months during the 1-year study period. The primary endpoint was recurrence of ulcer bleeding, which was predefined as clinical or laboratory evidence of gastrointestinal hemorrhage with a documented recurrence of ulcers on endoscopy. Lower gastrointestinal bleeding was a secondary endpoint.
Of 492 consecutive patients who were evaluated, 320 met inclusion criteria and were evenly divided into the clopidogrel plus placebo or the aspirin plus esomeprazole arms. Only 3 patients were lost to followup. During the study period, 34 cases of suspected gastrointestinal hemorrhage (defined as hematemesis, melena, or 2 g/dL decrease of hemoglobin) were identified. During endoscopy,14 cases were confirmed to be due to recurrent ulcer bleeding. Of these, 13 ulcers were in the clopidogrel arm (6 gastric ulcers, 5 duodenal, and 2 both) and 1 ulcer (duodenal) in the aspirin plus esomeprazole arm, a statistically significant difference (p=.001).
Fourteen patients were determined to have a lower gastrointestinal hemorrhage. Interestingly, these cases were evenly divided between the clopidogrel group (7 cases) and the aspirin plus esomeprazole (7 cases). This finding suggests the effect of esomeprazole in this study may be specific in preventing recurrent upper gastrointestinal ulcer formation and hemorrhage. The 2 groups had equivalent rates of recurrent ischemic events.
This study addresses an important clinical question, frequently encountered by hospitalists. The recommendation that clopidogrel be used instead of aspirin in patients who require antiplatelet therapy but have a history of upper gastrointestinal hemorrhage is based on studies using high-dose (325 mg) aspirin and excluded patients on acid-suppressing therapy. However, this study failed to prove noninferiority of clopidogrel to aspirin and esomeprazole for this indication. Although this study was not designed to show superiority of aspirin and esomeprazole over clopidogrel, these results indicate that this may be the case, and such a study would be timely. (CG)
Coronary-Artery Revascularization Before Elective Major Vascular Sugery
McFalls EO, Ward HB, Moritz TE, et al. Coronary-artery revascularization before elective major vascular surgery. N Engl J Med. 2004;351:2861-3.
Cardiac risk stratification and treatment prior to non-cardiac surgery is a frequent reason for medical consultation, and yet the optimal approach to managing these patients remains controversial. National guidelines, based on expert opinion and inferred from published data, suggest that preoperative cardiac revascularization be reserved for patients with unstable coronary syndromes or for whom coronary artery bypass grad ing has been shown to improve mortality. Despite these recommendations, there remains considerable variability in clinical practice, which is compounded by a paucity of prospective randomized trials to validate one approach over another.
In this multicenter randomized controlled trial, McFalls et al. studied whether coronary artery revascularization prior to elective vascular surgery would reduce mortality among a cohort of patients with angiographically documented stable coronary artery disease. The investigators evaluated 5859 patients from 18 centers scheduled for abdominal aortic aneurysm or lower extremity vascular surgery. Patients felt to be at high risk for perioperative cardiac complications based on cardiology consultation, established clinical criteria, or the presence of ischemia on stress imaging studies were referred for coronary angiography. Of this cohort, 4669 (80%) were excluded due to subsequent determination of insufficient cardiac risk (28%), urgent need for vascular surgery (18%), severe comorbid illness (13%), patient preference (11%), or prior revascularization without new ischemia (11%). Of the 1190 patients who underwent angiography, 680 were excluded due to protocol criteria including: the absence of obstructive coronary artery disease (54%), coronary disease not amenable to revascularization (32%), led main artery stenosis ≥ 50% (8%), led ventricular ejection fraction <20% (2%), or severe aortic stenosis (AVA<1.0 cm2) (1%).
Of the 510 patients who remained, 252 were randomized to proceed with vascular surgery with optimal medical management, of which 9 crossed over due to the need for urgent cardiac revascularization. Two hundred fifty-eight patients were randomized to elective preoperative revascularization; 99 underwent CABG, 141 underwent PCI, and 18 were excluded due to need for urgent vascular surgery, patient preference, or in one case, stroke. Both groups were similar with respect to baseline clinical variables, including the incidence of previous myocardial infarction, congestive heart failure, diabetes mellitus, led ventricular ejection fraction, and 3vessel coronary artery disease. They were also similar in the use of perioperative betablockers (~ 85%), statins, and aspirin.
At 2.7 years after randomization, mortality was 22% in the revascularization group and 22% in the medical management group, the relative risk was 0.98 (95% CI 0.7-1.37; p=.92), which was not statistically significant. The median time from randomization to vascular surgery was 54 days in the revascularization group and 18 days in the medical management group not undergoing revascularization (p<.001). Although not designed to address short-term outcomes, there were no differences in the rates of early postoperative myocardial infarction, death, or hospital length of stay. It is also worth noting that 316 of the 510 patients who were ultimately randomized had undergone nuclear imaging studies, of which 226 (72%) had moderate to large reversible perfusion defects detected. These outcome data suggest that the presence of reversible perfusions defects is not in itself a reason for preoperative revascularization.
This well-designed study demonstrates that in the absence of unstable coronary syndromes, led main disease, severe aortic stenosis, or severely depressed led ventricular ejection fraction, there is no morbidity or mortality benefit to revascularization among patients with stable coronary artery disease prior to vascular surgery. Because vascular surgery is the highest risk category among non-cardiac procedures, it may be reasonable to extend these findings to lower risk surgeries as well, and in this sense this study is particularly relevant to consultative practice. While this study provides clear evidence on how to manage this cohort of patients, it remains unclear what the optimal strategy is to identify and manage those patients who were excluded from the trial. (DF)
Amiodarone or a Implantable Cardioverter-Defibrilator for Congestive Heart Failure
Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 20;352:225-37.
Ventricular arrhythmias are the leading cause of sudden cardiac death in patients with systolic heart failure. Treatment with antiarrhythmic drug therapy has failed to improve survival in these patients, due to their proarrhythmic effects. Unlike other antiarrhythmics, amiodarone is a drug with low proarrhythmic effects. Some studies have suggested that amiodarone may be beneficial in patients with systolic heart failure. Conversely, several primary and secondary prevention trials have demonstrated that placement of an implantable cardioverter-defibrillator (ICD) confers a survival benefit in patients with ischemic cardiomyopathy. However, the role of ICDs in nonischemic heart failure remained unproven.
Bardy and colleagues developed the Sudden Cardiac Death in Heart Failure Trial (SCDHeFT) to evaluate the hypothesis that treatment with amiodarone or a shock-only, single-lead ICD would decrease death from any cause in a population of patients with mild to moderate heart failure. They randomly assigned 2521 patients with New York Heart Association (NYHA) class II or II heart failure (and a led ventricular ejection fraction (LVEF) of 35% or less to conventional medical therapy plus placebo, conventional therapy plus treatment with amiodarone or conventional therapy plus a conservatively programmed, shock-only, single-lead ICD.
Fifty-two percent of patients had ischemic heart failure and 48% had nonischemic heart failure. Placebo and amiodarone were given in double-blind fashion. The primary endpoint was death from any cause with a median followup of 45.5 months. The results were as follows:
Placebo Group - 244 deaths (29% Death Rate)
Amiodarone Group - 240 deaths (28% Death Rate)
ICD Group - 182 deaths (22% Death Rate)
Patients treated with amiodarone had a similar risk of death as those who received placebo (hazard ratio, 1.06; 97.5% CI: 0.86–1.30; p=0.53). Patients implanted with an ICD had a 23% decreased risk of death when compared with those who received placebo (0.77; 97.5% CI: 0.62–0.96; p=.007). This resulted in an absolute risk reduction of 7.2% at 5 years. The authors concluded that in patients with NYHA class II or III heart failure and a LVEF of 35% or less, implantation of a single-lead, shock-only ICD reduced overall mortality by 23%, while treatment with amiodarone had no effect on survival. The benefit of ICD placement reached or approached significance in both the ischemic (hazard ratio .79, CI: 0.60–1.04, p= .05) and nonischemic (hazard ratio 0.73, CI: 0.50–1.07, p= 0.06) subgroups.
It is important to note that an additional subgroup analysis showed that ICD therapy had a significant survival benefit only in NYHA class II patients but not in NYHA class III patients. Amiodarone therapy had no benefit in class II patients and actually decreased survival in class III patients compared to those receiving placebo. In light of results from previous trials that demonstrated a greater survival benefit from ICD placement with worsening ejection fraction in patients with ischemic heart failure, the authors were unable to explain whether the differences in subclasses were biologically plausible.
This study is important for several reasons. First, it suggested that patients with systolic heart failure due to either ischemic or non ischemic causes would benefit from placement of an ICD. Second, these results support the conclusions of previous trials that demonstrate a survival advantage of ICD placement in patients with ischemic heart failure. Finally, this study also demonstrates that amiodarone therapy offers no survival benefit in this population of patients. (JL)
Clopidogrel versus Aspirin and Esomeprazole to Prevent Recurrent Ulcer Bleeding
Chan F, Ching J, Hung L, et al. Clopidogrel versus aspirin and esomeprazole to prevent recurrent ulcer bleeding. N Engl J Med. 2005;352:238-44.
The optimal choice of antiplatelet therapy for patients with coronary heart disease who have had a recent upper gastrointestinal hemorrhage has not been well studied. Clopidogrel has been shown to cause fewer episodes of gastrointestinal hemorrhage than aspirin, but it is unknown whether clopidogrel monotherapy is in fact superior to aspirin plus a protonpump inhibitor. In this prospective, randomized, doubleblind trial, Chan and colleagues hypothesize that clopidogrel monotherapy would “not be inferior” to aspirin plus esomeprazole in a population of patients who had recovered from aspirin-induced hemorrhagic ulcers.
The study population was drawn from patients taking aspirin who were evaluated for an upper gastrointestinal bleed and had ulcer disease documented on endoscopy. Patients with documented Helicobacter pylori infection were treated with a 1-week course of a standard triple-drug regimen. All subjects, regardless of H. pylori status, were treated with an 8-week course of proton-pump inhibitors (PPI). Inclusion criteria included endoscopic confirmation of ulcer healing and successful eradication of H. pylori, if it was present. The location of the ulcers was not specified in the study.
Exclusion criteria included use of nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 inhibitors, anticoagulant drugs, corticosteroids, or other anti-platelet agents; history of gastric surgery; presence of erosive esophagitis; gastric outlet obstruction; cancer; need for dialysis; or terminal illness.
Subjects who met the inclusion criteria were randomized to receive either 75 mg of clopidogrel and placebo or 80 mg of aspirin daily plus 20 mg of esomeprazole twice a day for a 12 months. Patients returned for evaluation every 3 months during the 1-year study period. The primary endpoint was recurrence of ulcer bleeding, which was predefined as clinical or laboratory evidence of gastrointestinal hemorrhage with a documented recurrence of ulcers on endoscopy. Lower gastrointestinal bleeding was a secondary endpoint.
Of 492 consecutive patients who were evaluated, 320 met inclusion criteria and were evenly divided into the clopidogrel plus placebo or the aspirin plus esomeprazole arms. Only 3 patients were lost to followup. During the study period, 34 cases of suspected gastrointestinal hemorrhage (defined as hematemesis, melena, or 2 g/dL decrease of hemoglobin) were identified. During endoscopy,14 cases were confirmed to be due to recurrent ulcer bleeding. Of these, 13 ulcers were in the clopidogrel arm (6 gastric ulcers, 5 duodenal, and 2 both) and 1 ulcer (duodenal) in the aspirin plus esomeprazole arm, a statistically significant difference (p=.001).
Fourteen patients were determined to have a lower gastrointestinal hemorrhage. Interestingly, these cases were evenly divided between the clopidogrel group (7 cases) and the aspirin plus esomeprazole (7 cases). This finding suggests the effect of esomeprazole in this study may be specific in preventing recurrent upper gastrointestinal ulcer formation and hemorrhage. The 2 groups had equivalent rates of recurrent ischemic events.
This study addresses an important clinical question, frequently encountered by hospitalists. The recommendation that clopidogrel be used instead of aspirin in patients who require antiplatelet therapy but have a history of upper gastrointestinal hemorrhage is based on studies using high-dose (325 mg) aspirin and excluded patients on acid-suppressing therapy. However, this study failed to prove noninferiority of clopidogrel to aspirin and esomeprazole for this indication. Although this study was not designed to show superiority of aspirin and esomeprazole over clopidogrel, these results indicate that this may be the case, and such a study would be timely. (CG)
Coronary-Artery Revascularization Before Elective Major Vascular Sugery
McFalls EO, Ward HB, Moritz TE, et al. Coronary-artery revascularization before elective major vascular surgery. N Engl J Med. 2004;351:2861-3.
Cardiac risk stratification and treatment prior to non-cardiac surgery is a frequent reason for medical consultation, and yet the optimal approach to managing these patients remains controversial. National guidelines, based on expert opinion and inferred from published data, suggest that preoperative cardiac revascularization be reserved for patients with unstable coronary syndromes or for whom coronary artery bypass grad ing has been shown to improve mortality. Despite these recommendations, there remains considerable variability in clinical practice, which is compounded by a paucity of prospective randomized trials to validate one approach over another.
In this multicenter randomized controlled trial, McFalls et al. studied whether coronary artery revascularization prior to elective vascular surgery would reduce mortality among a cohort of patients with angiographically documented stable coronary artery disease. The investigators evaluated 5859 patients from 18 centers scheduled for abdominal aortic aneurysm or lower extremity vascular surgery. Patients felt to be at high risk for perioperative cardiac complications based on cardiology consultation, established clinical criteria, or the presence of ischemia on stress imaging studies were referred for coronary angiography. Of this cohort, 4669 (80%) were excluded due to subsequent determination of insufficient cardiac risk (28%), urgent need for vascular surgery (18%), severe comorbid illness (13%), patient preference (11%), or prior revascularization without new ischemia (11%). Of the 1190 patients who underwent angiography, 680 were excluded due to protocol criteria including: the absence of obstructive coronary artery disease (54%), coronary disease not amenable to revascularization (32%), led main artery stenosis ≥ 50% (8%), led ventricular ejection fraction <20% (2%), or severe aortic stenosis (AVA<1.0 cm2) (1%).
Of the 510 patients who remained, 252 were randomized to proceed with vascular surgery with optimal medical management, of which 9 crossed over due to the need for urgent cardiac revascularization. Two hundred fifty-eight patients were randomized to elective preoperative revascularization; 99 underwent CABG, 141 underwent PCI, and 18 were excluded due to need for urgent vascular surgery, patient preference, or in one case, stroke. Both groups were similar with respect to baseline clinical variables, including the incidence of previous myocardial infarction, congestive heart failure, diabetes mellitus, led ventricular ejection fraction, and 3vessel coronary artery disease. They were also similar in the use of perioperative betablockers (~ 85%), statins, and aspirin.
At 2.7 years after randomization, mortality was 22% in the revascularization group and 22% in the medical management group, the relative risk was 0.98 (95% CI 0.7-1.37; p=.92), which was not statistically significant. The median time from randomization to vascular surgery was 54 days in the revascularization group and 18 days in the medical management group not undergoing revascularization (p<.001). Although not designed to address short-term outcomes, there were no differences in the rates of early postoperative myocardial infarction, death, or hospital length of stay. It is also worth noting that 316 of the 510 patients who were ultimately randomized had undergone nuclear imaging studies, of which 226 (72%) had moderate to large reversible perfusion defects detected. These outcome data suggest that the presence of reversible perfusions defects is not in itself a reason for preoperative revascularization.
This well-designed study demonstrates that in the absence of unstable coronary syndromes, led main disease, severe aortic stenosis, or severely depressed led ventricular ejection fraction, there is no morbidity or mortality benefit to revascularization among patients with stable coronary artery disease prior to vascular surgery. Because vascular surgery is the highest risk category among non-cardiac procedures, it may be reasonable to extend these findings to lower risk surgeries as well, and in this sense this study is particularly relevant to consultative practice. While this study provides clear evidence on how to manage this cohort of patients, it remains unclear what the optimal strategy is to identify and manage those patients who were excluded from the trial. (DF)
Amiodarone or a Implantable Cardioverter-Defibrilator for Congestive Heart Failure
Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 20;352:225-37.
Ventricular arrhythmias are the leading cause of sudden cardiac death in patients with systolic heart failure. Treatment with antiarrhythmic drug therapy has failed to improve survival in these patients, due to their proarrhythmic effects. Unlike other antiarrhythmics, amiodarone is a drug with low proarrhythmic effects. Some studies have suggested that amiodarone may be beneficial in patients with systolic heart failure. Conversely, several primary and secondary prevention trials have demonstrated that placement of an implantable cardioverter-defibrillator (ICD) confers a survival benefit in patients with ischemic cardiomyopathy. However, the role of ICDs in nonischemic heart failure remained unproven.
Bardy and colleagues developed the Sudden Cardiac Death in Heart Failure Trial (SCDHeFT) to evaluate the hypothesis that treatment with amiodarone or a shock-only, single-lead ICD would decrease death from any cause in a population of patients with mild to moderate heart failure. They randomly assigned 2521 patients with New York Heart Association (NYHA) class II or II heart failure (and a led ventricular ejection fraction (LVEF) of 35% or less to conventional medical therapy plus placebo, conventional therapy plus treatment with amiodarone or conventional therapy plus a conservatively programmed, shock-only, single-lead ICD.
Fifty-two percent of patients had ischemic heart failure and 48% had nonischemic heart failure. Placebo and amiodarone were given in double-blind fashion. The primary endpoint was death from any cause with a median followup of 45.5 months. The results were as follows:
Placebo Group - 244 deaths (29% Death Rate)
Amiodarone Group - 240 deaths (28% Death Rate)
ICD Group - 182 deaths (22% Death Rate)
Patients treated with amiodarone had a similar risk of death as those who received placebo (hazard ratio, 1.06; 97.5% CI: 0.86–1.30; p=0.53). Patients implanted with an ICD had a 23% decreased risk of death when compared with those who received placebo (0.77; 97.5% CI: 0.62–0.96; p=.007). This resulted in an absolute risk reduction of 7.2% at 5 years. The authors concluded that in patients with NYHA class II or III heart failure and a LVEF of 35% or less, implantation of a single-lead, shock-only ICD reduced overall mortality by 23%, while treatment with amiodarone had no effect on survival. The benefit of ICD placement reached or approached significance in both the ischemic (hazard ratio .79, CI: 0.60–1.04, p= .05) and nonischemic (hazard ratio 0.73, CI: 0.50–1.07, p= 0.06) subgroups.
It is important to note that an additional subgroup analysis showed that ICD therapy had a significant survival benefit only in NYHA class II patients but not in NYHA class III patients. Amiodarone therapy had no benefit in class II patients and actually decreased survival in class III patients compared to those receiving placebo. In light of results from previous trials that demonstrated a greater survival benefit from ICD placement with worsening ejection fraction in patients with ischemic heart failure, the authors were unable to explain whether the differences in subclasses were biologically plausible.
This study is important for several reasons. First, it suggested that patients with systolic heart failure due to either ischemic or non ischemic causes would benefit from placement of an ICD. Second, these results support the conclusions of previous trials that demonstrate a survival advantage of ICD placement in patients with ischemic heart failure. Finally, this study also demonstrates that amiodarone therapy offers no survival benefit in this population of patients. (JL)
Clopidogrel versus Aspirin and Esomeprazole to Prevent Recurrent Ulcer Bleeding
Chan F, Ching J, Hung L, et al. Clopidogrel versus aspirin and esomeprazole to prevent recurrent ulcer bleeding. N Engl J Med. 2005;352:238-44.
The optimal choice of antiplatelet therapy for patients with coronary heart disease who have had a recent upper gastrointestinal hemorrhage has not been well studied. Clopidogrel has been shown to cause fewer episodes of gastrointestinal hemorrhage than aspirin, but it is unknown whether clopidogrel monotherapy is in fact superior to aspirin plus a protonpump inhibitor. In this prospective, randomized, doubleblind trial, Chan and colleagues hypothesize that clopidogrel monotherapy would “not be inferior” to aspirin plus esomeprazole in a population of patients who had recovered from aspirin-induced hemorrhagic ulcers.
The study population was drawn from patients taking aspirin who were evaluated for an upper gastrointestinal bleed and had ulcer disease documented on endoscopy. Patients with documented Helicobacter pylori infection were treated with a 1-week course of a standard triple-drug regimen. All subjects, regardless of H. pylori status, were treated with an 8-week course of proton-pump inhibitors (PPI). Inclusion criteria included endoscopic confirmation of ulcer healing and successful eradication of H. pylori, if it was present. The location of the ulcers was not specified in the study.
Exclusion criteria included use of nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 inhibitors, anticoagulant drugs, corticosteroids, or other anti-platelet agents; history of gastric surgery; presence of erosive esophagitis; gastric outlet obstruction; cancer; need for dialysis; or terminal illness.
Subjects who met the inclusion criteria were randomized to receive either 75 mg of clopidogrel and placebo or 80 mg of aspirin daily plus 20 mg of esomeprazole twice a day for a 12 months. Patients returned for evaluation every 3 months during the 1-year study period. The primary endpoint was recurrence of ulcer bleeding, which was predefined as clinical or laboratory evidence of gastrointestinal hemorrhage with a documented recurrence of ulcers on endoscopy. Lower gastrointestinal bleeding was a secondary endpoint.
Of 492 consecutive patients who were evaluated, 320 met inclusion criteria and were evenly divided into the clopidogrel plus placebo or the aspirin plus esomeprazole arms. Only 3 patients were lost to followup. During the study period, 34 cases of suspected gastrointestinal hemorrhage (defined as hematemesis, melena, or 2 g/dL decrease of hemoglobin) were identified. During endoscopy,14 cases were confirmed to be due to recurrent ulcer bleeding. Of these, 13 ulcers were in the clopidogrel arm (6 gastric ulcers, 5 duodenal, and 2 both) and 1 ulcer (duodenal) in the aspirin plus esomeprazole arm, a statistically significant difference (p=.001).
Fourteen patients were determined to have a lower gastrointestinal hemorrhage. Interestingly, these cases were evenly divided between the clopidogrel group (7 cases) and the aspirin plus esomeprazole (7 cases). This finding suggests the effect of esomeprazole in this study may be specific in preventing recurrent upper gastrointestinal ulcer formation and hemorrhage. The 2 groups had equivalent rates of recurrent ischemic events.
This study addresses an important clinical question, frequently encountered by hospitalists. The recommendation that clopidogrel be used instead of aspirin in patients who require antiplatelet therapy but have a history of upper gastrointestinal hemorrhage is based on studies using high-dose (325 mg) aspirin and excluded patients on acid-suppressing therapy. However, this study failed to prove noninferiority of clopidogrel to aspirin and esomeprazole for this indication. Although this study was not designed to show superiority of aspirin and esomeprazole over clopidogrel, these results indicate that this may be the case, and such a study would be timely. (CG)
Other Literature of Interest
1. Carratala J, FernandezSabe N, Ortega L, et al. Outpatient care compared with hospitalization for community-acquired pneumonia: a randomized trial in low-risk patients. Ann Intern Med. 2005;142: 165-72.
The appropriate triage and management of patients with community-acquired pneumonia (CAP) has important implications for patient outcomes and the allocation of health care resources. Despite the availability of validated risk stratification tools significant variability in clinical practice which results in hospitalization rates that are often inconsistent with the severity of illness. In this unblinded, randomized controlled trial, 224 patients with CAP and a low-risk pneumonia severity index (PSI) score between 51 and 90 (class II and III) were randomized to outpatient oral levofloxacin therapy versus inpatient sequential intravenous and oral levofloxacin therapy. Exclusion criteria included quinolone allergy or use within the previous 3 months, PaO2 < 60 mm Hg, complicated pleural effusion, lung abscess, metastatic infection, inability to maintain oral intake, and severe psychosocial problems precluding outpatient therapy. In an intention-to-treat analysis, the primary endpoints, of cure of pneumonia (resolution of signs, symptoms, and radiographic changes at 30 days), absence of adverse drug reactions, medical complications, or need for hospitalization at 30 days were achieved in 83.6% of outpatients and in 80.7% of hospitalized patients. For the secondary endpoint of patient satisfaction, 91.2% of outpatients versus 79.1% of hospitalized patients (p=.03) were satisfied, but there were no differences between groups with respect to the secondary endpoint of health-related quality of life. Mortality was similar between the 2 groups, and although the study was not sufficiently powered to address this outcome, and interestingly there was trend toward increased medical complications in the hospitalized patients.
Limitations of this study include lack of blinding by investigators and questions about whether the results can be generalized given the geographic variation in microbial susceptibility to quinolone antibiotics. As the authors suggest, this study also highlights limitations in the PSI scoring system, given that patients with clinical findings and comorbidities who would never be treated in the outpatient setting may in fact fall into low-risk PSI categories. These concerns notwithstanding, this study adds to our ability to identify an additional subset of patients with CAP who can be safely managed as outpatients.
2. Choudhry NK, Fletcher RH, Soumerai SB. Systematic review: the relationship between clinical experience and quality of health care.Ann Intern Med. 2005;142:260-73.
Early in the hospital medicine movement, when it was clear that hospitalists provided more efficient care than their colleagues, experience was cited as a reason for this difference. If, for example, a hospitalist cares for patients with community-acquired pneumonia daily, he or she is more likely to make the transition to oral antibiotics sooner, resulting in a shorter length of stay. Everyone recognized the hospitalists were younger, but is it plausible their “inexperience” explained the difference in care?
Choudhry and colleagues explored the available data surrounding clinical experience and quality of care delivered by physicians. They found few studies that specifically evaluated the effects of experience on quality of care. They did find articles that looked at quality of care and included experience or age as part of the physician characteristics
that possibly explained the differences. They reviewed 59 articles, available on MEDLINE, published since 1966. Forty-five studies found an inverse relationship between increasing experience and performance. For example, physicians more recently out of training programs were more familiar with evidence-based therapies for myocardial infarction and more familiar with NIH recommendations for treatment of breast cancer. Experienced physicians were less likely to screen for hypertension and more likely to prescribe inappropriate medications for elderly patients. This led them to the unexpected conclusion that experienced physicians may be at risk for providing lower-quality care and may need improvement interventions. An accompanying editorial by Drs. Weinberger, Duffy, and Cassel of the American Board of Internal Medicine stated, “The profession cannot ignore this striking finding and its implications: Practice does not make perfect, but it must be accompanied by ongoing active effort to maintain competence and quality of care.” They urged all physicians to “embrace the concepts behind maintenance of (board) certification.”
The image of Marcus Welby, MD, would lead one to believe that experience promotes higher quality care. But don’t ask a hospitalist: Many aren’t old enough to remember seeing him on television.
3. Kucher N, Koo S, Quiroz R, et al. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med. 2005;352:969-77.
March was DVT (deep vein thrombosis) Awareness Month. Despite the availability of numerous guidelines, providers fail to consistently prescribe prophylactic measures against venous thromboembolism (VTE) for their hospitalized patients who meet criteria for prophylaxis.
Kucher and colleagues tested an innovative approach to remind providers to undertake such measures for their patients. They designed a computer program to identify hospitalized patients at increased risk for VTE who were not presently receiving VTE prophylaxis. The program reviewed the records of inpatients on the medical and surgical services and assigned a VTE risk score for each patient based on their history (i.e., history of cancer, hypercoagulability, etc.) and their present medical treatment (i.e., hormone therapy, prescribed bed rest, etc.). For patients considered “high risk” for VTE, the computer reviewed orders to identify ongoing use of VTE prophylactic measures. High-risk patients not receiving prophylactic therapies were randomized into 2 groups. The responsible physician in the intervention group received an electronic alert about the risk of VTE in their patient. No alerts were sent to the physicians in the control group. Physicians who received the alerts were forced to acknowledge the alert by either actively withholding prophylaxis or ordering prophylaxis (mechanical or pharmacologic measures). Patients were followed for 90 days with a primary endpoint of clinically diagnosed, objectively confirmed deep vein thrombosis (DVT) or pulmonary embolism (PE). The primary endpoint occurred in 8.2% of the control group versus 4.9% in the invention group (p<.001). The alert reduced the risk of DVT or PE at 90 days by 41% (p=.001).
The results of the study are interesting. The authors acknowledged that many physicians had patients in both groups. So receiving 1 alert may have affected their use of prophylaxis in both groups. They also could not eliminate the possibility of diagnostic bias. Prophylaxis was not blinded and VTE testing was not routinely performed. Would physicians be more likely to order an imaging study for symptomatic patients on no prophylaxis than patients on prophylaxis? Nevertheless, for hospitals that have sufficient computer resources, implementation of such alerts can elevate physician awareness about VTE and other clinical conditions.
4. Lau DT, Kasper JD, Pofer DE, et al. Hospitalization and death associated with potentially inappropriate medication prescriptions among elderly nursing home residents. Arch Intern Med. 2005;165: 68-74.
Lau and colleagues studied the impact of potentially inappropriate medications among residents of longtermcare facilities. They used information from a 1996 national survey of home residents. The sample included 3372 residents, 65 years and older, who lived in a nursing home for 3 months or longer. Over half of the residents were older than 85 years old and 75% were female. Only 10% were black. Nearly two thirds had dementia or other mental disorders. The study used the Beers Criteria to define potentially inappropriate medications. The potential errors in medications were categorized as 1 of 3 types:
- inappropriate choice of medication
- excessive medication dosage
- drug–disease interactions
Residents were considered to have a potentially inappropriate medication if their medication administration records revealed any of the above findings.
A univariate analysis showed that the risk of hospitalization was almost 30% higher among residents who received potentially inappropriate medications in the preceding month and 33% higher among residents who received potentially inappropriate medications for 2 consecutive months, compared with residents with no inappropriate medication exposure. The odds of death in any month were 21% higher among residents who had inappropriate medication exposure during the month of death or the preceeding month, compared with those with no inappropriate medication exposure.
These findings can be generalized to the inpatient setting, where hospitalists have the opportunity to influence and modify prescribing practices in the elderly population.
5. Lessnau KD. Is chest radiography necessary after uncomplicated insertion of a triplelumen catheter in the right internal jugular vein, using the anterior approach? Chest. 2005;127:220-3.
The routine use of chest radiography to confirm proper triplelumen catheter (TLC) placement may be an unnecessary and costly intervention. Lessnau conducted a prospective observational study of 100 consecutive patients over a 4-month period who required non-urgent TLC placement. The primary operators of the procedure included 18 medical residents, 3 pulmonary fellows, and a pulmonary attending with supervision provided for more junior clinicians. Operators followed a standardized approach to TLC placement utilizing the anterior approach to the right internal jugular vein. Complicated procedures were predefined as any procedure that required more than 3 needle passes, resulted in hemorrhage or hematoma formation (where there was concern for pneumothorax), or an absence of blood return in any of the TLC’s lumens. All subjects underwent routine post-procedure chest radiography to determine proper placement of the catheter and to exclude pneumothorax. A blinded radiologist reviewed these images.
Ninety-eight of the 100 catheters were in proper position. One malpositioned catheter was 7 cm above the right atrium in a patient who was 215 cm (>7 feet) tall. The second was noted to be in an S-shaped position on chest radiography. This procedure had required 20 needle passes and 5 slides of the catheter; additionally, blood return was inadequate in 2 lumens of the catheter. An operator reported a possible complication in 10 other procedures, but the only clinical finding in these cases was the development of a local hematoma in 1 patient. Eighty-eight patients had uncomplicated insertions and had normal chest radiographs. There were no pneumothoraces.
This study demonstrates that in carefully controlled and supervised situations, as described in the study, routine chest radiography may be omitted if the insertion goes smoothly. It is important to note that these results are specific to the technique described in the study (using the anterior approach to the right internal jugular, using a short finder needle to initially locate the vein) and cannot be extrapolated to other methods of TLC insertion. Important limitations of the study include the sample size of only 100 patients and the use of only a single anatomic approach to TLC insertion. These findings, although an important first step, will need to be reproduced on a larger scale before we can recommend the cessation of routine chest radiography after TLC placement on a more widespread basis.
6. Safdar N, Fine JP, Maki DG. Metaanalysis: methods for diagnosing intravascular devicerelated bloodstream infection. Ann Intern Med. 2005;142:451-66.
Intravascular device (IVD)–related blood stream infections are a frequent cause of morbidity and mortality, and yet there is lack of a clear consensus on the most accurate method to make this diagnosis.
In this metaanalysis, Safdar et al. reviewed 185 studies, including 8 different diagnostic tests, for the detection of IVD-related bloodstream infections, of which 51 studies met the inclusion criteria. Tests were divided into IVD-sparing and those requiring IVD removal. Pooled sensitivity and specificity, summary measures of accuracy, and the mean log odds ratio were determined. The most accurate IVD-sparing test was paired quantitative blood cultures (simultaneous blood cultures from the IVD and a peripheral site, with a positive result defined as an IVD-site microorganism concentration 3–5 times greater than peripheral site) with a sensitivity of 0.87 (95% CI: 0.83–0.91) and specificity of 0.98 (95% CI: 0.97–0.99). This was followed by quantitative IVD-drawn blood cultures alone (positive result defined as growth of ≥100 CFU), with a sensitivity of 0.77 (95% CI: 0.69–0.85) and a specificity of 0.90 (95% CI: 0.88–0.92). IVD-drawn qualitative blood cultures had a sensitivity of 0.87 (95% CI: 0.80–0.94) and a specificity of 0.83 (95% CI: 0.78–0.88), and IVD- and peripheral-drawn qualitative blood cultures with differential time to positivity had a sensitivity of 0.85 (95% CI: 0.78–0.92) and specificity of 0.81 (95% CI: 0.81–0.97).
The most accurate test requiring IVD removal was quantitative catheter segment culture (segment of catheter is flushed or sonicated and plated, positive if ≥1000 CFU), with sensitivity of 0.83 (95% CI: 0.78–0.88) and specificity of 0.87 (95% CI: 0.85–0.89), followed by semi-quantitative catheter segment culture (5cm segment plated, positive if ≥ 15 CFU) with sensitivity of 0.82 (95% CI: 0.81–0.89) and specificity of 0.82 (95% CI: 0.80–0.84). The least accurate was qualitative catheter segment culture (positive if any growth) with a sensitivity of 0.90 (95% CI: 0.83–0.97) and specificity of 0.72 (95% CI: 0.66–0.78).
The limitations of this study include heterogeneity of study design, including limited data on the use of antibiotics before culture data was obtained and the baseline prevalence of bacteremia in the study populations. In addition, all data was obtained prior to the widespread use of antibiotic-coated catheters. While these results support the catheter-tip quantitative culture techniques that are already widely in use, they are less applicable to blood culture testing techniques, because quantitative assays are rarely used. Fortunately, all of these assays have a high negative predictive value, and false-positive results can be minimized by reserving testing for patients in whom there is moderate-to-high pretest probability of IVD related bloodstream infection.
7. Sopena N, Sabria M, Neunos 2000 Study Group. Multicenter study of hospital-acquired pneumonia in non-ICU patients. Chest. 2005;127:213-9.
A growing body of literature exists on hospital-acquired pneumonia (HAP) in the ICU setting. Sopena and colleagues extend the HAP literature to the non-ICU setting in a multicenter cross-sectional study. Cases of HAP were identified if clinical or radiographic evidence of pneumonia developed 72 hours after admission or within 10 days of a previous discharge. Patients who developed pneumonia in the ICU were excluded from analysis.
During an 18-month study period, 165 cases were identified with complete clinical and microbiologic data. The incidence of HAP was 3.1 ± 1.4 per 1000 hospital admissions. Ninety-eight (59.4%) patients diagnosed with HAP had severe underlying diseases that were classified as fatal (<1 year) or ultimately fatal (in 5 years). Extrinsic risk factors observed in patients with HAP included concurrent steroid use (29%), antibiotic therapy (53.3%), use of H2 blockers (37%), and hospitalization greater than 5 days (76%). Microbiologic data were positive in 60 (36.4%) cases. Streptococcus pneumoniae was diagnosed in 16 cases (9.7%), enterobacteriaceae in 8 (4.8%), Legionella pneumophila in 7 (4.2%), Aspergillus sp in 7 (4.2%), Pseudomonas aeruginosa in 7 (4.2%). Four cases of Staphylococcus aureus were diagnosed (3%), only one of which was methicillin resistant.
Complications of HAP occurred in 52.1% of cases and included respiratory failure (34.5%), pleural effusion (20.6%), septic shock (9.6%), renal failure (4.8%), and empyema (2.4%). Forty-three (26%) patients died during the hospitalization; 23 of these cases were directly attributed to HAP.
A limitation of the study is that the incidence of HAP was somewhat lower than reported in the literature and thus might represent an unintended sampling bias. Moreover, the study demonstrated underlying factors seen in patients with HAP, but these are not necessarily causative. Results useful to hospitalists include a higher than expected rate of Legionella and Aspergillus sp causing HAP in this population. A Legionella outbreak was not the explanation, as these cases were diagnosed in 5 different hospitals. The high frequency of adverse outcomes associated with HAP should alert hospitalists to the risk of nosocomial pneumonia in the non-ICU setting.
1. Carratala J, FernandezSabe N, Ortega L, et al. Outpatient care compared with hospitalization for community-acquired pneumonia: a randomized trial in low-risk patients. Ann Intern Med. 2005;142: 165-72.
The appropriate triage and management of patients with community-acquired pneumonia (CAP) has important implications for patient outcomes and the allocation of health care resources. Despite the availability of validated risk stratification tools significant variability in clinical practice which results in hospitalization rates that are often inconsistent with the severity of illness. In this unblinded, randomized controlled trial, 224 patients with CAP and a low-risk pneumonia severity index (PSI) score between 51 and 90 (class II and III) were randomized to outpatient oral levofloxacin therapy versus inpatient sequential intravenous and oral levofloxacin therapy. Exclusion criteria included quinolone allergy or use within the previous 3 months, PaO2 < 60 mm Hg, complicated pleural effusion, lung abscess, metastatic infection, inability to maintain oral intake, and severe psychosocial problems precluding outpatient therapy. In an intention-to-treat analysis, the primary endpoints, of cure of pneumonia (resolution of signs, symptoms, and radiographic changes at 30 days), absence of adverse drug reactions, medical complications, or need for hospitalization at 30 days were achieved in 83.6% of outpatients and in 80.7% of hospitalized patients. For the secondary endpoint of patient satisfaction, 91.2% of outpatients versus 79.1% of hospitalized patients (p=.03) were satisfied, but there were no differences between groups with respect to the secondary endpoint of health-related quality of life. Mortality was similar between the 2 groups, and although the study was not sufficiently powered to address this outcome, and interestingly there was trend toward increased medical complications in the hospitalized patients.
Limitations of this study include lack of blinding by investigators and questions about whether the results can be generalized given the geographic variation in microbial susceptibility to quinolone antibiotics. As the authors suggest, this study also highlights limitations in the PSI scoring system, given that patients with clinical findings and comorbidities who would never be treated in the outpatient setting may in fact fall into low-risk PSI categories. These concerns notwithstanding, this study adds to our ability to identify an additional subset of patients with CAP who can be safely managed as outpatients.
2. Choudhry NK, Fletcher RH, Soumerai SB. Systematic review: the relationship between clinical experience and quality of health care.Ann Intern Med. 2005;142:260-73.
Early in the hospital medicine movement, when it was clear that hospitalists provided more efficient care than their colleagues, experience was cited as a reason for this difference. If, for example, a hospitalist cares for patients with community-acquired pneumonia daily, he or she is more likely to make the transition to oral antibiotics sooner, resulting in a shorter length of stay. Everyone recognized the hospitalists were younger, but is it plausible their “inexperience” explained the difference in care?
Choudhry and colleagues explored the available data surrounding clinical experience and quality of care delivered by physicians. They found few studies that specifically evaluated the effects of experience on quality of care. They did find articles that looked at quality of care and included experience or age as part of the physician characteristics
that possibly explained the differences. They reviewed 59 articles, available on MEDLINE, published since 1966. Forty-five studies found an inverse relationship between increasing experience and performance. For example, physicians more recently out of training programs were more familiar with evidence-based therapies for myocardial infarction and more familiar with NIH recommendations for treatment of breast cancer. Experienced physicians were less likely to screen for hypertension and more likely to prescribe inappropriate medications for elderly patients. This led them to the unexpected conclusion that experienced physicians may be at risk for providing lower-quality care and may need improvement interventions. An accompanying editorial by Drs. Weinberger, Duffy, and Cassel of the American Board of Internal Medicine stated, “The profession cannot ignore this striking finding and its implications: Practice does not make perfect, but it must be accompanied by ongoing active effort to maintain competence and quality of care.” They urged all physicians to “embrace the concepts behind maintenance of (board) certification.”
The image of Marcus Welby, MD, would lead one to believe that experience promotes higher quality care. But don’t ask a hospitalist: Many aren’t old enough to remember seeing him on television.
3. Kucher N, Koo S, Quiroz R, et al. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med. 2005;352:969-77.
March was DVT (deep vein thrombosis) Awareness Month. Despite the availability of numerous guidelines, providers fail to consistently prescribe prophylactic measures against venous thromboembolism (VTE) for their hospitalized patients who meet criteria for prophylaxis.
Kucher and colleagues tested an innovative approach to remind providers to undertake such measures for their patients. They designed a computer program to identify hospitalized patients at increased risk for VTE who were not presently receiving VTE prophylaxis. The program reviewed the records of inpatients on the medical and surgical services and assigned a VTE risk score for each patient based on their history (i.e., history of cancer, hypercoagulability, etc.) and their present medical treatment (i.e., hormone therapy, prescribed bed rest, etc.). For patients considered “high risk” for VTE, the computer reviewed orders to identify ongoing use of VTE prophylactic measures. High-risk patients not receiving prophylactic therapies were randomized into 2 groups. The responsible physician in the intervention group received an electronic alert about the risk of VTE in their patient. No alerts were sent to the physicians in the control group. Physicians who received the alerts were forced to acknowledge the alert by either actively withholding prophylaxis or ordering prophylaxis (mechanical or pharmacologic measures). Patients were followed for 90 days with a primary endpoint of clinically diagnosed, objectively confirmed deep vein thrombosis (DVT) or pulmonary embolism (PE). The primary endpoint occurred in 8.2% of the control group versus 4.9% in the invention group (p<.001). The alert reduced the risk of DVT or PE at 90 days by 41% (p=.001).
The results of the study are interesting. The authors acknowledged that many physicians had patients in both groups. So receiving 1 alert may have affected their use of prophylaxis in both groups. They also could not eliminate the possibility of diagnostic bias. Prophylaxis was not blinded and VTE testing was not routinely performed. Would physicians be more likely to order an imaging study for symptomatic patients on no prophylaxis than patients on prophylaxis? Nevertheless, for hospitals that have sufficient computer resources, implementation of such alerts can elevate physician awareness about VTE and other clinical conditions.
4. Lau DT, Kasper JD, Pofer DE, et al. Hospitalization and death associated with potentially inappropriate medication prescriptions among elderly nursing home residents. Arch Intern Med. 2005;165: 68-74.
Lau and colleagues studied the impact of potentially inappropriate medications among residents of longtermcare facilities. They used information from a 1996 national survey of home residents. The sample included 3372 residents, 65 years and older, who lived in a nursing home for 3 months or longer. Over half of the residents were older than 85 years old and 75% were female. Only 10% were black. Nearly two thirds had dementia or other mental disorders. The study used the Beers Criteria to define potentially inappropriate medications. The potential errors in medications were categorized as 1 of 3 types:
- inappropriate choice of medication
- excessive medication dosage
- drug–disease interactions
Residents were considered to have a potentially inappropriate medication if their medication administration records revealed any of the above findings.
A univariate analysis showed that the risk of hospitalization was almost 30% higher among residents who received potentially inappropriate medications in the preceding month and 33% higher among residents who received potentially inappropriate medications for 2 consecutive months, compared with residents with no inappropriate medication exposure. The odds of death in any month were 21% higher among residents who had inappropriate medication exposure during the month of death or the preceeding month, compared with those with no inappropriate medication exposure.
These findings can be generalized to the inpatient setting, where hospitalists have the opportunity to influence and modify prescribing practices in the elderly population.
5. Lessnau KD. Is chest radiography necessary after uncomplicated insertion of a triplelumen catheter in the right internal jugular vein, using the anterior approach? Chest. 2005;127:220-3.
The routine use of chest radiography to confirm proper triplelumen catheter (TLC) placement may be an unnecessary and costly intervention. Lessnau conducted a prospective observational study of 100 consecutive patients over a 4-month period who required non-urgent TLC placement. The primary operators of the procedure included 18 medical residents, 3 pulmonary fellows, and a pulmonary attending with supervision provided for more junior clinicians. Operators followed a standardized approach to TLC placement utilizing the anterior approach to the right internal jugular vein. Complicated procedures were predefined as any procedure that required more than 3 needle passes, resulted in hemorrhage or hematoma formation (where there was concern for pneumothorax), or an absence of blood return in any of the TLC’s lumens. All subjects underwent routine post-procedure chest radiography to determine proper placement of the catheter and to exclude pneumothorax. A blinded radiologist reviewed these images.
Ninety-eight of the 100 catheters were in proper position. One malpositioned catheter was 7 cm above the right atrium in a patient who was 215 cm (>7 feet) tall. The second was noted to be in an S-shaped position on chest radiography. This procedure had required 20 needle passes and 5 slides of the catheter; additionally, blood return was inadequate in 2 lumens of the catheter. An operator reported a possible complication in 10 other procedures, but the only clinical finding in these cases was the development of a local hematoma in 1 patient. Eighty-eight patients had uncomplicated insertions and had normal chest radiographs. There were no pneumothoraces.
This study demonstrates that in carefully controlled and supervised situations, as described in the study, routine chest radiography may be omitted if the insertion goes smoothly. It is important to note that these results are specific to the technique described in the study (using the anterior approach to the right internal jugular, using a short finder needle to initially locate the vein) and cannot be extrapolated to other methods of TLC insertion. Important limitations of the study include the sample size of only 100 patients and the use of only a single anatomic approach to TLC insertion. These findings, although an important first step, will need to be reproduced on a larger scale before we can recommend the cessation of routine chest radiography after TLC placement on a more widespread basis.
6. Safdar N, Fine JP, Maki DG. Metaanalysis: methods for diagnosing intravascular devicerelated bloodstream infection. Ann Intern Med. 2005;142:451-66.
Intravascular device (IVD)–related blood stream infections are a frequent cause of morbidity and mortality, and yet there is lack of a clear consensus on the most accurate method to make this diagnosis.
In this metaanalysis, Safdar et al. reviewed 185 studies, including 8 different diagnostic tests, for the detection of IVD-related bloodstream infections, of which 51 studies met the inclusion criteria. Tests were divided into IVD-sparing and those requiring IVD removal. Pooled sensitivity and specificity, summary measures of accuracy, and the mean log odds ratio were determined. The most accurate IVD-sparing test was paired quantitative blood cultures (simultaneous blood cultures from the IVD and a peripheral site, with a positive result defined as an IVD-site microorganism concentration 3–5 times greater than peripheral site) with a sensitivity of 0.87 (95% CI: 0.83–0.91) and specificity of 0.98 (95% CI: 0.97–0.99). This was followed by quantitative IVD-drawn blood cultures alone (positive result defined as growth of ≥100 CFU), with a sensitivity of 0.77 (95% CI: 0.69–0.85) and a specificity of 0.90 (95% CI: 0.88–0.92). IVD-drawn qualitative blood cultures had a sensitivity of 0.87 (95% CI: 0.80–0.94) and a specificity of 0.83 (95% CI: 0.78–0.88), and IVD- and peripheral-drawn qualitative blood cultures with differential time to positivity had a sensitivity of 0.85 (95% CI: 0.78–0.92) and specificity of 0.81 (95% CI: 0.81–0.97).
The most accurate test requiring IVD removal was quantitative catheter segment culture (segment of catheter is flushed or sonicated and plated, positive if ≥1000 CFU), with sensitivity of 0.83 (95% CI: 0.78–0.88) and specificity of 0.87 (95% CI: 0.85–0.89), followed by semi-quantitative catheter segment culture (5cm segment plated, positive if ≥ 15 CFU) with sensitivity of 0.82 (95% CI: 0.81–0.89) and specificity of 0.82 (95% CI: 0.80–0.84). The least accurate was qualitative catheter segment culture (positive if any growth) with a sensitivity of 0.90 (95% CI: 0.83–0.97) and specificity of 0.72 (95% CI: 0.66–0.78).
The limitations of this study include heterogeneity of study design, including limited data on the use of antibiotics before culture data was obtained and the baseline prevalence of bacteremia in the study populations. In addition, all data was obtained prior to the widespread use of antibiotic-coated catheters. While these results support the catheter-tip quantitative culture techniques that are already widely in use, they are less applicable to blood culture testing techniques, because quantitative assays are rarely used. Fortunately, all of these assays have a high negative predictive value, and false-positive results can be minimized by reserving testing for patients in whom there is moderate-to-high pretest probability of IVD related bloodstream infection.
7. Sopena N, Sabria M, Neunos 2000 Study Group. Multicenter study of hospital-acquired pneumonia in non-ICU patients. Chest. 2005;127:213-9.
A growing body of literature exists on hospital-acquired pneumonia (HAP) in the ICU setting. Sopena and colleagues extend the HAP literature to the non-ICU setting in a multicenter cross-sectional study. Cases of HAP were identified if clinical or radiographic evidence of pneumonia developed 72 hours after admission or within 10 days of a previous discharge. Patients who developed pneumonia in the ICU were excluded from analysis.
During an 18-month study period, 165 cases were identified with complete clinical and microbiologic data. The incidence of HAP was 3.1 ± 1.4 per 1000 hospital admissions. Ninety-eight (59.4%) patients diagnosed with HAP had severe underlying diseases that were classified as fatal (<1 year) or ultimately fatal (in 5 years). Extrinsic risk factors observed in patients with HAP included concurrent steroid use (29%), antibiotic therapy (53.3%), use of H2 blockers (37%), and hospitalization greater than 5 days (76%). Microbiologic data were positive in 60 (36.4%) cases. Streptococcus pneumoniae was diagnosed in 16 cases (9.7%), enterobacteriaceae in 8 (4.8%), Legionella pneumophila in 7 (4.2%), Aspergillus sp in 7 (4.2%), Pseudomonas aeruginosa in 7 (4.2%). Four cases of Staphylococcus aureus were diagnosed (3%), only one of which was methicillin resistant.
Complications of HAP occurred in 52.1% of cases and included respiratory failure (34.5%), pleural effusion (20.6%), septic shock (9.6%), renal failure (4.8%), and empyema (2.4%). Forty-three (26%) patients died during the hospitalization; 23 of these cases were directly attributed to HAP.
A limitation of the study is that the incidence of HAP was somewhat lower than reported in the literature and thus might represent an unintended sampling bias. Moreover, the study demonstrated underlying factors seen in patients with HAP, but these are not necessarily causative. Results useful to hospitalists include a higher than expected rate of Legionella and Aspergillus sp causing HAP in this population. A Legionella outbreak was not the explanation, as these cases were diagnosed in 5 different hospitals. The high frequency of adverse outcomes associated with HAP should alert hospitalists to the risk of nosocomial pneumonia in the non-ICU setting.
1. Carratala J, FernandezSabe N, Ortega L, et al. Outpatient care compared with hospitalization for community-acquired pneumonia: a randomized trial in low-risk patients. Ann Intern Med. 2005;142: 165-72.
The appropriate triage and management of patients with community-acquired pneumonia (CAP) has important implications for patient outcomes and the allocation of health care resources. Despite the availability of validated risk stratification tools significant variability in clinical practice which results in hospitalization rates that are often inconsistent with the severity of illness. In this unblinded, randomized controlled trial, 224 patients with CAP and a low-risk pneumonia severity index (PSI) score between 51 and 90 (class II and III) were randomized to outpatient oral levofloxacin therapy versus inpatient sequential intravenous and oral levofloxacin therapy. Exclusion criteria included quinolone allergy or use within the previous 3 months, PaO2 < 60 mm Hg, complicated pleural effusion, lung abscess, metastatic infection, inability to maintain oral intake, and severe psychosocial problems precluding outpatient therapy. In an intention-to-treat analysis, the primary endpoints, of cure of pneumonia (resolution of signs, symptoms, and radiographic changes at 30 days), absence of adverse drug reactions, medical complications, or need for hospitalization at 30 days were achieved in 83.6% of outpatients and in 80.7% of hospitalized patients. For the secondary endpoint of patient satisfaction, 91.2% of outpatients versus 79.1% of hospitalized patients (p=.03) were satisfied, but there were no differences between groups with respect to the secondary endpoint of health-related quality of life. Mortality was similar between the 2 groups, and although the study was not sufficiently powered to address this outcome, and interestingly there was trend toward increased medical complications in the hospitalized patients.
Limitations of this study include lack of blinding by investigators and questions about whether the results can be generalized given the geographic variation in microbial susceptibility to quinolone antibiotics. As the authors suggest, this study also highlights limitations in the PSI scoring system, given that patients with clinical findings and comorbidities who would never be treated in the outpatient setting may in fact fall into low-risk PSI categories. These concerns notwithstanding, this study adds to our ability to identify an additional subset of patients with CAP who can be safely managed as outpatients.
2. Choudhry NK, Fletcher RH, Soumerai SB. Systematic review: the relationship between clinical experience and quality of health care.Ann Intern Med. 2005;142:260-73.
Early in the hospital medicine movement, when it was clear that hospitalists provided more efficient care than their colleagues, experience was cited as a reason for this difference. If, for example, a hospitalist cares for patients with community-acquired pneumonia daily, he or she is more likely to make the transition to oral antibiotics sooner, resulting in a shorter length of stay. Everyone recognized the hospitalists were younger, but is it plausible their “inexperience” explained the difference in care?
Choudhry and colleagues explored the available data surrounding clinical experience and quality of care delivered by physicians. They found few studies that specifically evaluated the effects of experience on quality of care. They did find articles that looked at quality of care and included experience or age as part of the physician characteristics
that possibly explained the differences. They reviewed 59 articles, available on MEDLINE, published since 1966. Forty-five studies found an inverse relationship between increasing experience and performance. For example, physicians more recently out of training programs were more familiar with evidence-based therapies for myocardial infarction and more familiar with NIH recommendations for treatment of breast cancer. Experienced physicians were less likely to screen for hypertension and more likely to prescribe inappropriate medications for elderly patients. This led them to the unexpected conclusion that experienced physicians may be at risk for providing lower-quality care and may need improvement interventions. An accompanying editorial by Drs. Weinberger, Duffy, and Cassel of the American Board of Internal Medicine stated, “The profession cannot ignore this striking finding and its implications: Practice does not make perfect, but it must be accompanied by ongoing active effort to maintain competence and quality of care.” They urged all physicians to “embrace the concepts behind maintenance of (board) certification.”
The image of Marcus Welby, MD, would lead one to believe that experience promotes higher quality care. But don’t ask a hospitalist: Many aren’t old enough to remember seeing him on television.
3. Kucher N, Koo S, Quiroz R, et al. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med. 2005;352:969-77.
March was DVT (deep vein thrombosis) Awareness Month. Despite the availability of numerous guidelines, providers fail to consistently prescribe prophylactic measures against venous thromboembolism (VTE) for their hospitalized patients who meet criteria for prophylaxis.
Kucher and colleagues tested an innovative approach to remind providers to undertake such measures for their patients. They designed a computer program to identify hospitalized patients at increased risk for VTE who were not presently receiving VTE prophylaxis. The program reviewed the records of inpatients on the medical and surgical services and assigned a VTE risk score for each patient based on their history (i.e., history of cancer, hypercoagulability, etc.) and their present medical treatment (i.e., hormone therapy, prescribed bed rest, etc.). For patients considered “high risk” for VTE, the computer reviewed orders to identify ongoing use of VTE prophylactic measures. High-risk patients not receiving prophylactic therapies were randomized into 2 groups. The responsible physician in the intervention group received an electronic alert about the risk of VTE in their patient. No alerts were sent to the physicians in the control group. Physicians who received the alerts were forced to acknowledge the alert by either actively withholding prophylaxis or ordering prophylaxis (mechanical or pharmacologic measures). Patients were followed for 90 days with a primary endpoint of clinically diagnosed, objectively confirmed deep vein thrombosis (DVT) or pulmonary embolism (PE). The primary endpoint occurred in 8.2% of the control group versus 4.9% in the invention group (p<.001). The alert reduced the risk of DVT or PE at 90 days by 41% (p=.001).
The results of the study are interesting. The authors acknowledged that many physicians had patients in both groups. So receiving 1 alert may have affected their use of prophylaxis in both groups. They also could not eliminate the possibility of diagnostic bias. Prophylaxis was not blinded and VTE testing was not routinely performed. Would physicians be more likely to order an imaging study for symptomatic patients on no prophylaxis than patients on prophylaxis? Nevertheless, for hospitals that have sufficient computer resources, implementation of such alerts can elevate physician awareness about VTE and other clinical conditions.
4. Lau DT, Kasper JD, Pofer DE, et al. Hospitalization and death associated with potentially inappropriate medication prescriptions among elderly nursing home residents. Arch Intern Med. 2005;165: 68-74.
Lau and colleagues studied the impact of potentially inappropriate medications among residents of longtermcare facilities. They used information from a 1996 national survey of home residents. The sample included 3372 residents, 65 years and older, who lived in a nursing home for 3 months or longer. Over half of the residents were older than 85 years old and 75% were female. Only 10% were black. Nearly two thirds had dementia or other mental disorders. The study used the Beers Criteria to define potentially inappropriate medications. The potential errors in medications were categorized as 1 of 3 types:
- inappropriate choice of medication
- excessive medication dosage
- drug–disease interactions
Residents were considered to have a potentially inappropriate medication if their medication administration records revealed any of the above findings.
A univariate analysis showed that the risk of hospitalization was almost 30% higher among residents who received potentially inappropriate medications in the preceding month and 33% higher among residents who received potentially inappropriate medications for 2 consecutive months, compared with residents with no inappropriate medication exposure. The odds of death in any month were 21% higher among residents who had inappropriate medication exposure during the month of death or the preceeding month, compared with those with no inappropriate medication exposure.
These findings can be generalized to the inpatient setting, where hospitalists have the opportunity to influence and modify prescribing practices in the elderly population.
5. Lessnau KD. Is chest radiography necessary after uncomplicated insertion of a triplelumen catheter in the right internal jugular vein, using the anterior approach? Chest. 2005;127:220-3.
The routine use of chest radiography to confirm proper triplelumen catheter (TLC) placement may be an unnecessary and costly intervention. Lessnau conducted a prospective observational study of 100 consecutive patients over a 4-month period who required non-urgent TLC placement. The primary operators of the procedure included 18 medical residents, 3 pulmonary fellows, and a pulmonary attending with supervision provided for more junior clinicians. Operators followed a standardized approach to TLC placement utilizing the anterior approach to the right internal jugular vein. Complicated procedures were predefined as any procedure that required more than 3 needle passes, resulted in hemorrhage or hematoma formation (where there was concern for pneumothorax), or an absence of blood return in any of the TLC’s lumens. All subjects underwent routine post-procedure chest radiography to determine proper placement of the catheter and to exclude pneumothorax. A blinded radiologist reviewed these images.
Ninety-eight of the 100 catheters were in proper position. One malpositioned catheter was 7 cm above the right atrium in a patient who was 215 cm (>7 feet) tall. The second was noted to be in an S-shaped position on chest radiography. This procedure had required 20 needle passes and 5 slides of the catheter; additionally, blood return was inadequate in 2 lumens of the catheter. An operator reported a possible complication in 10 other procedures, but the only clinical finding in these cases was the development of a local hematoma in 1 patient. Eighty-eight patients had uncomplicated insertions and had normal chest radiographs. There were no pneumothoraces.
This study demonstrates that in carefully controlled and supervised situations, as described in the study, routine chest radiography may be omitted if the insertion goes smoothly. It is important to note that these results are specific to the technique described in the study (using the anterior approach to the right internal jugular, using a short finder needle to initially locate the vein) and cannot be extrapolated to other methods of TLC insertion. Important limitations of the study include the sample size of only 100 patients and the use of only a single anatomic approach to TLC insertion. These findings, although an important first step, will need to be reproduced on a larger scale before we can recommend the cessation of routine chest radiography after TLC placement on a more widespread basis.
6. Safdar N, Fine JP, Maki DG. Metaanalysis: methods for diagnosing intravascular devicerelated bloodstream infection. Ann Intern Med. 2005;142:451-66.
Intravascular device (IVD)–related blood stream infections are a frequent cause of morbidity and mortality, and yet there is lack of a clear consensus on the most accurate method to make this diagnosis.
In this metaanalysis, Safdar et al. reviewed 185 studies, including 8 different diagnostic tests, for the detection of IVD-related bloodstream infections, of which 51 studies met the inclusion criteria. Tests were divided into IVD-sparing and those requiring IVD removal. Pooled sensitivity and specificity, summary measures of accuracy, and the mean log odds ratio were determined. The most accurate IVD-sparing test was paired quantitative blood cultures (simultaneous blood cultures from the IVD and a peripheral site, with a positive result defined as an IVD-site microorganism concentration 3–5 times greater than peripheral site) with a sensitivity of 0.87 (95% CI: 0.83–0.91) and specificity of 0.98 (95% CI: 0.97–0.99). This was followed by quantitative IVD-drawn blood cultures alone (positive result defined as growth of ≥100 CFU), with a sensitivity of 0.77 (95% CI: 0.69–0.85) and a specificity of 0.90 (95% CI: 0.88–0.92). IVD-drawn qualitative blood cultures had a sensitivity of 0.87 (95% CI: 0.80–0.94) and a specificity of 0.83 (95% CI: 0.78–0.88), and IVD- and peripheral-drawn qualitative blood cultures with differential time to positivity had a sensitivity of 0.85 (95% CI: 0.78–0.92) and specificity of 0.81 (95% CI: 0.81–0.97).
The most accurate test requiring IVD removal was quantitative catheter segment culture (segment of catheter is flushed or sonicated and plated, positive if ≥1000 CFU), with sensitivity of 0.83 (95% CI: 0.78–0.88) and specificity of 0.87 (95% CI: 0.85–0.89), followed by semi-quantitative catheter segment culture (5cm segment plated, positive if ≥ 15 CFU) with sensitivity of 0.82 (95% CI: 0.81–0.89) and specificity of 0.82 (95% CI: 0.80–0.84). The least accurate was qualitative catheter segment culture (positive if any growth) with a sensitivity of 0.90 (95% CI: 0.83–0.97) and specificity of 0.72 (95% CI: 0.66–0.78).
The limitations of this study include heterogeneity of study design, including limited data on the use of antibiotics before culture data was obtained and the baseline prevalence of bacteremia in the study populations. In addition, all data was obtained prior to the widespread use of antibiotic-coated catheters. While these results support the catheter-tip quantitative culture techniques that are already widely in use, they are less applicable to blood culture testing techniques, because quantitative assays are rarely used. Fortunately, all of these assays have a high negative predictive value, and false-positive results can be minimized by reserving testing for patients in whom there is moderate-to-high pretest probability of IVD related bloodstream infection.
7. Sopena N, Sabria M, Neunos 2000 Study Group. Multicenter study of hospital-acquired pneumonia in non-ICU patients. Chest. 2005;127:213-9.
A growing body of literature exists on hospital-acquired pneumonia (HAP) in the ICU setting. Sopena and colleagues extend the HAP literature to the non-ICU setting in a multicenter cross-sectional study. Cases of HAP were identified if clinical or radiographic evidence of pneumonia developed 72 hours after admission or within 10 days of a previous discharge. Patients who developed pneumonia in the ICU were excluded from analysis.
During an 18-month study period, 165 cases were identified with complete clinical and microbiologic data. The incidence of HAP was 3.1 ± 1.4 per 1000 hospital admissions. Ninety-eight (59.4%) patients diagnosed with HAP had severe underlying diseases that were classified as fatal (<1 year) or ultimately fatal (in 5 years). Extrinsic risk factors observed in patients with HAP included concurrent steroid use (29%), antibiotic therapy (53.3%), use of H2 blockers (37%), and hospitalization greater than 5 days (76%). Microbiologic data were positive in 60 (36.4%) cases. Streptococcus pneumoniae was diagnosed in 16 cases (9.7%), enterobacteriaceae in 8 (4.8%), Legionella pneumophila in 7 (4.2%), Aspergillus sp in 7 (4.2%), Pseudomonas aeruginosa in 7 (4.2%). Four cases of Staphylococcus aureus were diagnosed (3%), only one of which was methicillin resistant.
Complications of HAP occurred in 52.1% of cases and included respiratory failure (34.5%), pleural effusion (20.6%), septic shock (9.6%), renal failure (4.8%), and empyema (2.4%). Forty-three (26%) patients died during the hospitalization; 23 of these cases were directly attributed to HAP.
A limitation of the study is that the incidence of HAP was somewhat lower than reported in the literature and thus might represent an unintended sampling bias. Moreover, the study demonstrated underlying factors seen in patients with HAP, but these are not necessarily causative. Results useful to hospitalists include a higher than expected rate of Legionella and Aspergillus sp causing HAP in this population. A Legionella outbreak was not the explanation, as these cases were diagnosed in 5 different hospitals. The high frequency of adverse outcomes associated with HAP should alert hospitalists to the risk of nosocomial pneumonia in the non-ICU setting.