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Meta-analysis eyes impact of adherence to HCQ among SLE patients
Low serum levels of hydroxychloroquine (HCQ) among patients with systemic lupus erythematosus are associated with a threefold increased likelihood of physician- and patient-reported nonadherence to the medication. In addition, routine monitoring of HCQ levels are associated with improvements in adherence and disease activity.
Those are two key findings from a systematic review and meta-analysis published in Arthritis Care & Research.
“HCQ is recommended for all patients with systemic lupus erythematosus (SLE, or lupus) to reduce disease activity and improve damage-free-survival,” the authors, led by Shivani Garg, MD, of the University of Wisconsin–Madison, wrote in the article. “Yet, up to 83% of lupus patients are nonadherent to HCQ commonly because of poor understanding of benefits of HCQ, lack of motivation to continue therapy, and inflated concerns regarding side effects from HCQ use.”
For their analysis, the researchers drew from 17 published observational and interventional studies that measured HCQ levels and assessed adherence or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) in adults with SLE. They used forest plots to compare pooled estimates of correlations between HCQ levels and reported nonadherence, or SLEDAI scores. Patient-reported nonadherence was defined as less than 80% medication adherence reported, and physician-reported adherence was estimated based on physicians’ interpretations of the previous month’s adherence as reported by patients during clinic visits.
The study population consisted of 1,223 patients. Dr. Garg and colleagues found a threefold higher odds of reported nonadherence in patients with low HCQ levels (odds ratio, 2.95; P less than .001). The mean SLEDAI score was 3.14 points higher in a group with below-threshold HCQ levels on a priori analysis (P = .053), and 1.4 points higher in a group with HCQ levels below 500 ng/mL (P = .039). Among all patients, those with HCQ levels 750 ng/mL or greater had a 58% lower risk of active disease, and their SLEDAI score was 3.2 points lower. “Our study support levels greater than or equal to 750 ng/mL to be clinically meaningful and statistically significant to identify disease flare (change in SLEDAI greater than or equal to 3 points) and predict active disease (SLEDAI greater than or equal to 6),” the authors wrote.
In an interview, Michelle A. Petri, MD, MPH, took issue with the HCQ goal of 750 ng/mL or greater recommended by the authors. “I think that was premature,” said Dr. Petri, professor of medicine at Johns Hopkins University, Baltimore. “We presented data at last year’s ACR [which showed] that the level needs to be higher than that to prevent thrombosis. But it is important to open the discussion that HCQ blood levels are not just for nonadherence. I believe they will help us to reduce retinopathy, and also to make sure the dose remains in an efficacious range, such as what is needed to prevent thrombosis.”
Dr. Petri, who also directs the Hopkins Lupus Center, said that the study’s overall conclusions confirms the need for blood testing for HCQ to identify nonadherence. “Everyone remembers the saying of the [former] Surgeon General Dr. C. Everett Koop: ‘Drugs can’t work if patients don’t take them!’ – in particular, blood levels which represent what the patient has taken in the last month. I call blood levels the ‘lupus A1C.’ ”
She added that HCQ blood levels have utility for nonadherence, prediction of retinopathy, and prevention of thrombosis. Such tests “are now much more widely available, including by some large national laboratories such as Quest Diagnostics, as well as by Exagen. No more excuses.” LabCorp plans to start offering HCQ blood level testing by the middle of 2020, she said.
In their manuscript, the study authors acknowledged certain limitations of their analysis, including the fact that there were only four studies that measured HCQ levels and nonadherence or SLEDAI. “Second, most of the studies that examined the correlation between reported adherence and HCQ blood levels were performed in Europe, and there was only one small U.S. study,” they wrote. “Therefore, generalizability for our findings could be limited because of differences in cultural beliefs, social issues, and insurance/medical coverage in populations from diverse countries.”
The study authors reported having no disclosures. Dr. Petri disclosed that she has conducted research on HCQ that was funded by the National Institutes of Health. She has also conducted research for Exagen.
SOURCE: Garg S et al. Arthritis Care Res. 2020 Jan 31. doi: 10.1002/acr.24155.
Low serum levels of hydroxychloroquine (HCQ) among patients with systemic lupus erythematosus are associated with a threefold increased likelihood of physician- and patient-reported nonadherence to the medication. In addition, routine monitoring of HCQ levels are associated with improvements in adherence and disease activity.
Those are two key findings from a systematic review and meta-analysis published in Arthritis Care & Research.
“HCQ is recommended for all patients with systemic lupus erythematosus (SLE, or lupus) to reduce disease activity and improve damage-free-survival,” the authors, led by Shivani Garg, MD, of the University of Wisconsin–Madison, wrote in the article. “Yet, up to 83% of lupus patients are nonadherent to HCQ commonly because of poor understanding of benefits of HCQ, lack of motivation to continue therapy, and inflated concerns regarding side effects from HCQ use.”
For their analysis, the researchers drew from 17 published observational and interventional studies that measured HCQ levels and assessed adherence or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) in adults with SLE. They used forest plots to compare pooled estimates of correlations between HCQ levels and reported nonadherence, or SLEDAI scores. Patient-reported nonadherence was defined as less than 80% medication adherence reported, and physician-reported adherence was estimated based on physicians’ interpretations of the previous month’s adherence as reported by patients during clinic visits.
The study population consisted of 1,223 patients. Dr. Garg and colleagues found a threefold higher odds of reported nonadherence in patients with low HCQ levels (odds ratio, 2.95; P less than .001). The mean SLEDAI score was 3.14 points higher in a group with below-threshold HCQ levels on a priori analysis (P = .053), and 1.4 points higher in a group with HCQ levels below 500 ng/mL (P = .039). Among all patients, those with HCQ levels 750 ng/mL or greater had a 58% lower risk of active disease, and their SLEDAI score was 3.2 points lower. “Our study support levels greater than or equal to 750 ng/mL to be clinically meaningful and statistically significant to identify disease flare (change in SLEDAI greater than or equal to 3 points) and predict active disease (SLEDAI greater than or equal to 6),” the authors wrote.
In an interview, Michelle A. Petri, MD, MPH, took issue with the HCQ goal of 750 ng/mL or greater recommended by the authors. “I think that was premature,” said Dr. Petri, professor of medicine at Johns Hopkins University, Baltimore. “We presented data at last year’s ACR [which showed] that the level needs to be higher than that to prevent thrombosis. But it is important to open the discussion that HCQ blood levels are not just for nonadherence. I believe they will help us to reduce retinopathy, and also to make sure the dose remains in an efficacious range, such as what is needed to prevent thrombosis.”
Dr. Petri, who also directs the Hopkins Lupus Center, said that the study’s overall conclusions confirms the need for blood testing for HCQ to identify nonadherence. “Everyone remembers the saying of the [former] Surgeon General Dr. C. Everett Koop: ‘Drugs can’t work if patients don’t take them!’ – in particular, blood levels which represent what the patient has taken in the last month. I call blood levels the ‘lupus A1C.’ ”
She added that HCQ blood levels have utility for nonadherence, prediction of retinopathy, and prevention of thrombosis. Such tests “are now much more widely available, including by some large national laboratories such as Quest Diagnostics, as well as by Exagen. No more excuses.” LabCorp plans to start offering HCQ blood level testing by the middle of 2020, she said.
In their manuscript, the study authors acknowledged certain limitations of their analysis, including the fact that there were only four studies that measured HCQ levels and nonadherence or SLEDAI. “Second, most of the studies that examined the correlation between reported adherence and HCQ blood levels were performed in Europe, and there was only one small U.S. study,” they wrote. “Therefore, generalizability for our findings could be limited because of differences in cultural beliefs, social issues, and insurance/medical coverage in populations from diverse countries.”
The study authors reported having no disclosures. Dr. Petri disclosed that she has conducted research on HCQ that was funded by the National Institutes of Health. She has also conducted research for Exagen.
SOURCE: Garg S et al. Arthritis Care Res. 2020 Jan 31. doi: 10.1002/acr.24155.
Low serum levels of hydroxychloroquine (HCQ) among patients with systemic lupus erythematosus are associated with a threefold increased likelihood of physician- and patient-reported nonadherence to the medication. In addition, routine monitoring of HCQ levels are associated with improvements in adherence and disease activity.
Those are two key findings from a systematic review and meta-analysis published in Arthritis Care & Research.
“HCQ is recommended for all patients with systemic lupus erythematosus (SLE, or lupus) to reduce disease activity and improve damage-free-survival,” the authors, led by Shivani Garg, MD, of the University of Wisconsin–Madison, wrote in the article. “Yet, up to 83% of lupus patients are nonadherent to HCQ commonly because of poor understanding of benefits of HCQ, lack of motivation to continue therapy, and inflated concerns regarding side effects from HCQ use.”
For their analysis, the researchers drew from 17 published observational and interventional studies that measured HCQ levels and assessed adherence or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) in adults with SLE. They used forest plots to compare pooled estimates of correlations between HCQ levels and reported nonadherence, or SLEDAI scores. Patient-reported nonadherence was defined as less than 80% medication adherence reported, and physician-reported adherence was estimated based on physicians’ interpretations of the previous month’s adherence as reported by patients during clinic visits.
The study population consisted of 1,223 patients. Dr. Garg and colleagues found a threefold higher odds of reported nonadherence in patients with low HCQ levels (odds ratio, 2.95; P less than .001). The mean SLEDAI score was 3.14 points higher in a group with below-threshold HCQ levels on a priori analysis (P = .053), and 1.4 points higher in a group with HCQ levels below 500 ng/mL (P = .039). Among all patients, those with HCQ levels 750 ng/mL or greater had a 58% lower risk of active disease, and their SLEDAI score was 3.2 points lower. “Our study support levels greater than or equal to 750 ng/mL to be clinically meaningful and statistically significant to identify disease flare (change in SLEDAI greater than or equal to 3 points) and predict active disease (SLEDAI greater than or equal to 6),” the authors wrote.
In an interview, Michelle A. Petri, MD, MPH, took issue with the HCQ goal of 750 ng/mL or greater recommended by the authors. “I think that was premature,” said Dr. Petri, professor of medicine at Johns Hopkins University, Baltimore. “We presented data at last year’s ACR [which showed] that the level needs to be higher than that to prevent thrombosis. But it is important to open the discussion that HCQ blood levels are not just for nonadherence. I believe they will help us to reduce retinopathy, and also to make sure the dose remains in an efficacious range, such as what is needed to prevent thrombosis.”
Dr. Petri, who also directs the Hopkins Lupus Center, said that the study’s overall conclusions confirms the need for blood testing for HCQ to identify nonadherence. “Everyone remembers the saying of the [former] Surgeon General Dr. C. Everett Koop: ‘Drugs can’t work if patients don’t take them!’ – in particular, blood levels which represent what the patient has taken in the last month. I call blood levels the ‘lupus A1C.’ ”
She added that HCQ blood levels have utility for nonadherence, prediction of retinopathy, and prevention of thrombosis. Such tests “are now much more widely available, including by some large national laboratories such as Quest Diagnostics, as well as by Exagen. No more excuses.” LabCorp plans to start offering HCQ blood level testing by the middle of 2020, she said.
In their manuscript, the study authors acknowledged certain limitations of their analysis, including the fact that there were only four studies that measured HCQ levels and nonadherence or SLEDAI. “Second, most of the studies that examined the correlation between reported adherence and HCQ blood levels were performed in Europe, and there was only one small U.S. study,” they wrote. “Therefore, generalizability for our findings could be limited because of differences in cultural beliefs, social issues, and insurance/medical coverage in populations from diverse countries.”
The study authors reported having no disclosures. Dr. Petri disclosed that she has conducted research on HCQ that was funded by the National Institutes of Health. She has also conducted research for Exagen.
SOURCE: Garg S et al. Arthritis Care Res. 2020 Jan 31. doi: 10.1002/acr.24155.
FROM ARTHRITIS CARE & RESEARCH
Any dose of HPV vaccine is better than none
A single dose of the human papillomavirus vaccine is as effective as two or three doses for preventing cervical cancer in girls and women vaccinated at 15-19 years of age, based on data from a retrospective study of more than 100,000 girls and women.
The Centers for Disease Control and Prevention’s current recommendations include a two-dose vaccine schedule for the HPV vaccine for girls and boys younger than 15 years, and a three-dose schedule for girls and young women aged 16-26 years who had their first dose before turning 15.
However, rates of HPV vaccination in the United States fall short of those in other developed nations, and evidence supporting the protective value of a specific number of vaccine doses are mixed, wrote Ana M. Rodriguez, MD, MPH, of the University of Texas Medical Branch at Galveston, and colleagues. Fewer than three doses could have benefits, including easier logistics, lower costs, higher acceptance rates, and fewer side effects, they said. The study was published in Cancer.
The researchers reviewed data from 66,541 girls and women aged 9-26 years who had received at least one dose of HPV vaccine (4vHPV) between Jan. 1, 2006, and June 30, 2015, and 66,541 matched unvaccinated controls. The primary outcomes were histologically confirmed preinvasive cervical disease and high-grade cytology.
Overall, the adjusted hazard ratios for histologically confirmed preinvasive cervical disease among patients vaccinated at the ages of 15-19 years with one, two, and three doses were similar, at 0.64, 0.72, and 0.66, respectively, compared with unvaccinated individuals.
The risk of high-grade cytology was significantly lower for girls and women who received three doses at age 15-19 years, compared with unvaccinated individuals, but no difference was seen in high-grade cytology between unvaccinated individuals and those who received one or two doses. In addition, the unadjusted rate of preinvasive cervical disease at 5 years was 2.65% for unvaccinated teens aged 15-19 years, compared with 1.62%, 1.99%, and 1.86% in the one-, two- and three-dose groups, respectively.The findings were limited by several factors, including the use of billing codes to determine outcomes and the inability to determine potential vaccination through multiple insurance carriers, and the inclusion only of privately insured patients from the claims database, the researchers noted.
However, the results support findings from previous studies and show a similar level of association between varying vaccine doses and preinvasive cervical lesions in the 15- to 19-year-old population, they said.
“Efforts should focus on not only the need to initiate the HPV vaccine but also the need for beginning and continuing cervical cancer screening among young women who are vaccinated at older ages (18 years and older),” they said.
In an editorial accompanying the study, Julia M.L. Brotherton, PhD, MPH, and Karin Sundström, MD, PhD, of the University of Melbourne, Australia, and the Karolinska Institutet, Stockholm, respectively, wrote that the study’s strengths included the large numbers of girls and women who received a single dose of the HPV vaccine, compared with previous studies, as well as the adjustments for histories of sexually transmitted infections and pregnancy (Cancer. 2020 Feb 10. doi: 10.1002/cncr.32696). “Initial observational data from vaccination programs did not support equivalent one-dose protection against genital warts or cervical disease, but such data may have been confounded by potentially higher risk characteristics of women who only ever received one or two doses of an intended three-dose course i.e., women noncompliant with the vaccine program [amplified by the monitoring of outcomes among the initial catch-up populations of already infected women]) and by the inherent bias that prevalent infection/disease is more likely to become apparent coincidently with the earlier doses in a vaccine course,” they said. The study findings have implications for global goals to eliminate cervical cancer, the editorial authors noted.
“If one dose of an HPV vaccine were sufficient for effective protection, HPV vaccine implementation and scale-up would require less logistics (while being amenable to a periodic campaign approach), available doses could be extended further, and the overall cost would be lower,” they said.
The study was supported in part by the National Center for Advancing Translational Sciences of the National Institutes of Health, and by the Cancer Prevention Research Institute of Texas. The researchers had no financial conflicts to disclose.
Dr. Brotherton disclosed serving as an investigator for Seqirus and Merck; Dr. Sundström disclosed research funding for her institution from Merck and MSD Sweden.
SOURCE: Rodriguez AM et al. Cancer. 2020 Feb 10. doi: 10.1002/cncr.32700.
A single dose of the human papillomavirus vaccine is as effective as two or three doses for preventing cervical cancer in girls and women vaccinated at 15-19 years of age, based on data from a retrospective study of more than 100,000 girls and women.
The Centers for Disease Control and Prevention’s current recommendations include a two-dose vaccine schedule for the HPV vaccine for girls and boys younger than 15 years, and a three-dose schedule for girls and young women aged 16-26 years who had their first dose before turning 15.
However, rates of HPV vaccination in the United States fall short of those in other developed nations, and evidence supporting the protective value of a specific number of vaccine doses are mixed, wrote Ana M. Rodriguez, MD, MPH, of the University of Texas Medical Branch at Galveston, and colleagues. Fewer than three doses could have benefits, including easier logistics, lower costs, higher acceptance rates, and fewer side effects, they said. The study was published in Cancer.
The researchers reviewed data from 66,541 girls and women aged 9-26 years who had received at least one dose of HPV vaccine (4vHPV) between Jan. 1, 2006, and June 30, 2015, and 66,541 matched unvaccinated controls. The primary outcomes were histologically confirmed preinvasive cervical disease and high-grade cytology.
Overall, the adjusted hazard ratios for histologically confirmed preinvasive cervical disease among patients vaccinated at the ages of 15-19 years with one, two, and three doses were similar, at 0.64, 0.72, and 0.66, respectively, compared with unvaccinated individuals.
The risk of high-grade cytology was significantly lower for girls and women who received three doses at age 15-19 years, compared with unvaccinated individuals, but no difference was seen in high-grade cytology between unvaccinated individuals and those who received one or two doses. In addition, the unadjusted rate of preinvasive cervical disease at 5 years was 2.65% for unvaccinated teens aged 15-19 years, compared with 1.62%, 1.99%, and 1.86% in the one-, two- and three-dose groups, respectively.The findings were limited by several factors, including the use of billing codes to determine outcomes and the inability to determine potential vaccination through multiple insurance carriers, and the inclusion only of privately insured patients from the claims database, the researchers noted.
However, the results support findings from previous studies and show a similar level of association between varying vaccine doses and preinvasive cervical lesions in the 15- to 19-year-old population, they said.
“Efforts should focus on not only the need to initiate the HPV vaccine but also the need for beginning and continuing cervical cancer screening among young women who are vaccinated at older ages (18 years and older),” they said.
In an editorial accompanying the study, Julia M.L. Brotherton, PhD, MPH, and Karin Sundström, MD, PhD, of the University of Melbourne, Australia, and the Karolinska Institutet, Stockholm, respectively, wrote that the study’s strengths included the large numbers of girls and women who received a single dose of the HPV vaccine, compared with previous studies, as well as the adjustments for histories of sexually transmitted infections and pregnancy (Cancer. 2020 Feb 10. doi: 10.1002/cncr.32696). “Initial observational data from vaccination programs did not support equivalent one-dose protection against genital warts or cervical disease, but such data may have been confounded by potentially higher risk characteristics of women who only ever received one or two doses of an intended three-dose course i.e., women noncompliant with the vaccine program [amplified by the monitoring of outcomes among the initial catch-up populations of already infected women]) and by the inherent bias that prevalent infection/disease is more likely to become apparent coincidently with the earlier doses in a vaccine course,” they said. The study findings have implications for global goals to eliminate cervical cancer, the editorial authors noted.
“If one dose of an HPV vaccine were sufficient for effective protection, HPV vaccine implementation and scale-up would require less logistics (while being amenable to a periodic campaign approach), available doses could be extended further, and the overall cost would be lower,” they said.
The study was supported in part by the National Center for Advancing Translational Sciences of the National Institutes of Health, and by the Cancer Prevention Research Institute of Texas. The researchers had no financial conflicts to disclose.
Dr. Brotherton disclosed serving as an investigator for Seqirus and Merck; Dr. Sundström disclosed research funding for her institution from Merck and MSD Sweden.
SOURCE: Rodriguez AM et al. Cancer. 2020 Feb 10. doi: 10.1002/cncr.32700.
A single dose of the human papillomavirus vaccine is as effective as two or three doses for preventing cervical cancer in girls and women vaccinated at 15-19 years of age, based on data from a retrospective study of more than 100,000 girls and women.
The Centers for Disease Control and Prevention’s current recommendations include a two-dose vaccine schedule for the HPV vaccine for girls and boys younger than 15 years, and a three-dose schedule for girls and young women aged 16-26 years who had their first dose before turning 15.
However, rates of HPV vaccination in the United States fall short of those in other developed nations, and evidence supporting the protective value of a specific number of vaccine doses are mixed, wrote Ana M. Rodriguez, MD, MPH, of the University of Texas Medical Branch at Galveston, and colleagues. Fewer than three doses could have benefits, including easier logistics, lower costs, higher acceptance rates, and fewer side effects, they said. The study was published in Cancer.
The researchers reviewed data from 66,541 girls and women aged 9-26 years who had received at least one dose of HPV vaccine (4vHPV) between Jan. 1, 2006, and June 30, 2015, and 66,541 matched unvaccinated controls. The primary outcomes were histologically confirmed preinvasive cervical disease and high-grade cytology.
Overall, the adjusted hazard ratios for histologically confirmed preinvasive cervical disease among patients vaccinated at the ages of 15-19 years with one, two, and three doses were similar, at 0.64, 0.72, and 0.66, respectively, compared with unvaccinated individuals.
The risk of high-grade cytology was significantly lower for girls and women who received three doses at age 15-19 years, compared with unvaccinated individuals, but no difference was seen in high-grade cytology between unvaccinated individuals and those who received one or two doses. In addition, the unadjusted rate of preinvasive cervical disease at 5 years was 2.65% for unvaccinated teens aged 15-19 years, compared with 1.62%, 1.99%, and 1.86% in the one-, two- and three-dose groups, respectively.The findings were limited by several factors, including the use of billing codes to determine outcomes and the inability to determine potential vaccination through multiple insurance carriers, and the inclusion only of privately insured patients from the claims database, the researchers noted.
However, the results support findings from previous studies and show a similar level of association between varying vaccine doses and preinvasive cervical lesions in the 15- to 19-year-old population, they said.
“Efforts should focus on not only the need to initiate the HPV vaccine but also the need for beginning and continuing cervical cancer screening among young women who are vaccinated at older ages (18 years and older),” they said.
In an editorial accompanying the study, Julia M.L. Brotherton, PhD, MPH, and Karin Sundström, MD, PhD, of the University of Melbourne, Australia, and the Karolinska Institutet, Stockholm, respectively, wrote that the study’s strengths included the large numbers of girls and women who received a single dose of the HPV vaccine, compared with previous studies, as well as the adjustments for histories of sexually transmitted infections and pregnancy (Cancer. 2020 Feb 10. doi: 10.1002/cncr.32696). “Initial observational data from vaccination programs did not support equivalent one-dose protection against genital warts or cervical disease, but such data may have been confounded by potentially higher risk characteristics of women who only ever received one or two doses of an intended three-dose course i.e., women noncompliant with the vaccine program [amplified by the monitoring of outcomes among the initial catch-up populations of already infected women]) and by the inherent bias that prevalent infection/disease is more likely to become apparent coincidently with the earlier doses in a vaccine course,” they said. The study findings have implications for global goals to eliminate cervical cancer, the editorial authors noted.
“If one dose of an HPV vaccine were sufficient for effective protection, HPV vaccine implementation and scale-up would require less logistics (while being amenable to a periodic campaign approach), available doses could be extended further, and the overall cost would be lower,” they said.
The study was supported in part by the National Center for Advancing Translational Sciences of the National Institutes of Health, and by the Cancer Prevention Research Institute of Texas. The researchers had no financial conflicts to disclose.
Dr. Brotherton disclosed serving as an investigator for Seqirus and Merck; Dr. Sundström disclosed research funding for her institution from Merck and MSD Sweden.
SOURCE: Rodriguez AM et al. Cancer. 2020 Feb 10. doi: 10.1002/cncr.32700.
FROM CANCER
Key clinical point: HPV vaccination was similarly effective for preventing cervical cancer in girls and women who received 1, 2, or 3 doses at age 15-19 years.
Major finding: The adjusted hazard ratios for preinvasive cervical disease for women vaccinated at age 15-19 years with 1, 2, and 3 doses of the HPV vaccine were 0.64, 0.72, and 0.66 respectively.
Study details: The data come from a retrospective matched cohort study of 133,082 women from the Optum Clinformatics DataMart Database.
Disclosures: The study was supported in part by the National Center for Advancing Translational Sciences of the National Institutes of Health and by the Cancer Prevention Research Institute of Texas. The researchers disclosed no financial conflicts.
Source: Rodriguez AM et al. Cancer. 2020 Feb 10. doi: 10.1002/cncr.32700.
Abbreviated MRI equals standard protocol for high-risk breast cancer screens
CHICAGO – An abbreviated magnetic resonance imaging (MRI) protocol for screening individuals at high risk for breast cancer performed as well as a standard protocol, in about half the time and with greater patient satisfaction.
The abbreviated protocol also resulted in fewer false positive findings, with 5% fewer patients receiving biopsies for benign lesions than with a standard protocol (8.4% versus 13.7%, P less than .001).
Findings from the prospective 10-month trial conducted in the province of Ontario were presented by Jean Seely, MD, professor of radiology at the University of Ottawa, at the annual meeting of the Radiological Society of North America.
“The abbreviated protocol was shown to be as effective as the standard protocol in high-risk screening breast MRI, supporting previous studies,” said Dr. Seely. The shorter protocol took 16.3 minutes on average, compared with 27 minutes for the standard MRI protocol. This difference resulted in a 50% increase in institutional capacity, or a jump from two to three patients screened per hour.
In the province of Ontario, said Dr. Seely, women assessed at being at a 25% or greater lifetime risk of breast cancer receive MRIs as part of the Ontario Breast Screening Program (OBSP), which calculates risk by using the International Breast Cancer Intervention Study model.
For high-risk patients, the OBSP model provides annual mammography and an MRI for women between the ages of 30 and 60 years. Not only is the half-hour duration of the standard protocol resource-intensive, especially in regions with limited scanner availability, but patients may either be reluctant to undergo a half-hour scan, or not tolerate a lengthy scan very well.
Dr. Seely cited previous work (J Clin Oncol. 2014 Aug 1;32[22]:2304-10) showing that an abbreviated MRI protocol has similar accuracy as the full standard protocol. With the foundation of evidence from this study, Dr. Seely and her collaborators compared outcomes for high-risk patients who were screened with an abbreviated versus a standard protocol.
The abbreviated protocol, approved by the American College of Radiology, omits a final round of image acquisition sequences at the 9-minute mark after gadolinium administration, instead performing acquisition at 1, 2, 3, and 4 minutes after contrast delivery. Total time required for this protocol is just over 13 minutes, said Dr. Seely, and additional diagnostic MRIs were not required.
The trial was constructed so that the abbreviated protocol was used for the entire OBSP cohort for 10 months in 2018. Results were compared with those from the 12 previous months, when OBSP patients’ MRIs were performed using the standard protocol.
A total of 881 patients received standard-protocol MRIs; about three quarters (651) of those patients had previous MRI screening, while the remaining 230 patients had a baseline screen via the standard protocol.
Of the 658 patients in the abbreviated protocol group, 135, or about 20%, received the briefer scans as a baseline screen; the remast of the patients in this arm had received earlier MRI screening.
In addition to tracking scanning times, Dr. Seely and her collaborators also compared cancer detection rates, Breast Imaging Reporting and Data System (BI-RADS) assessment categories, positive predictive values, and the abnormal interpretation rate – that is, how many scans fell into BI-RADS categories 0, 4, and 5.
No significant difference was found between the rates of BI-RADs 0, 3, or 5 studies between the groups. Significantly fewer abbreviated scans fell into the BI-RADS 4 category, however (9.3% vs. 14.9%; P less than .001).
Similarly, the abnormal interpretation rate was 12.5% for the abbreviated protocol, compared with 17.5% for the standard protocol (P less than .007), with a correspondingly lower biopsy rate of 8.4% for the abbreviated protocol, compared with 13.7% for the standard protocol (P less than .001). The overall cancer detection rate did not differ between groups.
She and her colleagues will continue to track outcomes for those receiving abbreviated screening within the province of Ontario to track performance over time.
Dr. Seely reported that she had no relevant conflicts of interest. She reported no funding source beyond the province of Ontario.
koakes@mdedge.com
SOURCE: Seely J et al. RSNA 2019, Session RC-215-04.
CHICAGO – An abbreviated magnetic resonance imaging (MRI) protocol for screening individuals at high risk for breast cancer performed as well as a standard protocol, in about half the time and with greater patient satisfaction.
The abbreviated protocol also resulted in fewer false positive findings, with 5% fewer patients receiving biopsies for benign lesions than with a standard protocol (8.4% versus 13.7%, P less than .001).
Findings from the prospective 10-month trial conducted in the province of Ontario were presented by Jean Seely, MD, professor of radiology at the University of Ottawa, at the annual meeting of the Radiological Society of North America.
“The abbreviated protocol was shown to be as effective as the standard protocol in high-risk screening breast MRI, supporting previous studies,” said Dr. Seely. The shorter protocol took 16.3 minutes on average, compared with 27 minutes for the standard MRI protocol. This difference resulted in a 50% increase in institutional capacity, or a jump from two to three patients screened per hour.
In the province of Ontario, said Dr. Seely, women assessed at being at a 25% or greater lifetime risk of breast cancer receive MRIs as part of the Ontario Breast Screening Program (OBSP), which calculates risk by using the International Breast Cancer Intervention Study model.
For high-risk patients, the OBSP model provides annual mammography and an MRI for women between the ages of 30 and 60 years. Not only is the half-hour duration of the standard protocol resource-intensive, especially in regions with limited scanner availability, but patients may either be reluctant to undergo a half-hour scan, or not tolerate a lengthy scan very well.
Dr. Seely cited previous work (J Clin Oncol. 2014 Aug 1;32[22]:2304-10) showing that an abbreviated MRI protocol has similar accuracy as the full standard protocol. With the foundation of evidence from this study, Dr. Seely and her collaborators compared outcomes for high-risk patients who were screened with an abbreviated versus a standard protocol.
The abbreviated protocol, approved by the American College of Radiology, omits a final round of image acquisition sequences at the 9-minute mark after gadolinium administration, instead performing acquisition at 1, 2, 3, and 4 minutes after contrast delivery. Total time required for this protocol is just over 13 minutes, said Dr. Seely, and additional diagnostic MRIs were not required.
The trial was constructed so that the abbreviated protocol was used for the entire OBSP cohort for 10 months in 2018. Results were compared with those from the 12 previous months, when OBSP patients’ MRIs were performed using the standard protocol.
A total of 881 patients received standard-protocol MRIs; about three quarters (651) of those patients had previous MRI screening, while the remaining 230 patients had a baseline screen via the standard protocol.
Of the 658 patients in the abbreviated protocol group, 135, or about 20%, received the briefer scans as a baseline screen; the remast of the patients in this arm had received earlier MRI screening.
In addition to tracking scanning times, Dr. Seely and her collaborators also compared cancer detection rates, Breast Imaging Reporting and Data System (BI-RADS) assessment categories, positive predictive values, and the abnormal interpretation rate – that is, how many scans fell into BI-RADS categories 0, 4, and 5.
No significant difference was found between the rates of BI-RADs 0, 3, or 5 studies between the groups. Significantly fewer abbreviated scans fell into the BI-RADS 4 category, however (9.3% vs. 14.9%; P less than .001).
Similarly, the abnormal interpretation rate was 12.5% for the abbreviated protocol, compared with 17.5% for the standard protocol (P less than .007), with a correspondingly lower biopsy rate of 8.4% for the abbreviated protocol, compared with 13.7% for the standard protocol (P less than .001). The overall cancer detection rate did not differ between groups.
She and her colleagues will continue to track outcomes for those receiving abbreviated screening within the province of Ontario to track performance over time.
Dr. Seely reported that she had no relevant conflicts of interest. She reported no funding source beyond the province of Ontario.
koakes@mdedge.com
SOURCE: Seely J et al. RSNA 2019, Session RC-215-04.
CHICAGO – An abbreviated magnetic resonance imaging (MRI) protocol for screening individuals at high risk for breast cancer performed as well as a standard protocol, in about half the time and with greater patient satisfaction.
The abbreviated protocol also resulted in fewer false positive findings, with 5% fewer patients receiving biopsies for benign lesions than with a standard protocol (8.4% versus 13.7%, P less than .001).
Findings from the prospective 10-month trial conducted in the province of Ontario were presented by Jean Seely, MD, professor of radiology at the University of Ottawa, at the annual meeting of the Radiological Society of North America.
“The abbreviated protocol was shown to be as effective as the standard protocol in high-risk screening breast MRI, supporting previous studies,” said Dr. Seely. The shorter protocol took 16.3 minutes on average, compared with 27 minutes for the standard MRI protocol. This difference resulted in a 50% increase in institutional capacity, or a jump from two to three patients screened per hour.
In the province of Ontario, said Dr. Seely, women assessed at being at a 25% or greater lifetime risk of breast cancer receive MRIs as part of the Ontario Breast Screening Program (OBSP), which calculates risk by using the International Breast Cancer Intervention Study model.
For high-risk patients, the OBSP model provides annual mammography and an MRI for women between the ages of 30 and 60 years. Not only is the half-hour duration of the standard protocol resource-intensive, especially in regions with limited scanner availability, but patients may either be reluctant to undergo a half-hour scan, or not tolerate a lengthy scan very well.
Dr. Seely cited previous work (J Clin Oncol. 2014 Aug 1;32[22]:2304-10) showing that an abbreviated MRI protocol has similar accuracy as the full standard protocol. With the foundation of evidence from this study, Dr. Seely and her collaborators compared outcomes for high-risk patients who were screened with an abbreviated versus a standard protocol.
The abbreviated protocol, approved by the American College of Radiology, omits a final round of image acquisition sequences at the 9-minute mark after gadolinium administration, instead performing acquisition at 1, 2, 3, and 4 minutes after contrast delivery. Total time required for this protocol is just over 13 minutes, said Dr. Seely, and additional diagnostic MRIs were not required.
The trial was constructed so that the abbreviated protocol was used for the entire OBSP cohort for 10 months in 2018. Results were compared with those from the 12 previous months, when OBSP patients’ MRIs were performed using the standard protocol.
A total of 881 patients received standard-protocol MRIs; about three quarters (651) of those patients had previous MRI screening, while the remaining 230 patients had a baseline screen via the standard protocol.
Of the 658 patients in the abbreviated protocol group, 135, or about 20%, received the briefer scans as a baseline screen; the remast of the patients in this arm had received earlier MRI screening.
In addition to tracking scanning times, Dr. Seely and her collaborators also compared cancer detection rates, Breast Imaging Reporting and Data System (BI-RADS) assessment categories, positive predictive values, and the abnormal interpretation rate – that is, how many scans fell into BI-RADS categories 0, 4, and 5.
No significant difference was found between the rates of BI-RADs 0, 3, or 5 studies between the groups. Significantly fewer abbreviated scans fell into the BI-RADS 4 category, however (9.3% vs. 14.9%; P less than .001).
Similarly, the abnormal interpretation rate was 12.5% for the abbreviated protocol, compared with 17.5% for the standard protocol (P less than .007), with a correspondingly lower biopsy rate of 8.4% for the abbreviated protocol, compared with 13.7% for the standard protocol (P less than .001). The overall cancer detection rate did not differ between groups.
She and her colleagues will continue to track outcomes for those receiving abbreviated screening within the province of Ontario to track performance over time.
Dr. Seely reported that she had no relevant conflicts of interest. She reported no funding source beyond the province of Ontario.
koakes@mdedge.com
SOURCE: Seely J et al. RSNA 2019, Session RC-215-04.
REPORTING FROM RSNA 2019
White Hispanic Mohs patients less informed about skin cancer risks
White Hispanic adults report a lower quality of life and less knowledge of skin cancer and sun protection behaviors than white non-Hispanic adults, survey results of 175 adults with nonmelanoma skin cancer show.
“The incidence of nonmelanoma skin cancer (NMSC) is lower in Hispanics when compared to Caucasians, but a high index of suspicion is needed given ethnic differences in presentation,” wrote Ali Rajabi-Estarabadi, MD, of the University of Miami, and colleagues.
Hispanic patients with NMSC tend to be younger than non-Hispanic white patients, and their basal cell carcinomas are more likely to be pigmented, the investigators noted. Although previous research suggests ethnic disparities in NMSC, factors including sun safety knowledge and quality of life after diagnosis have not been well studied, they said.
With this in mind, the investigators conducted a survey of white Hispanics and non-Hispanics treated for NMSC. The results were published as a research letter in the Journal of the American Academy of Dermatology.
The investigators recruited 175 consecutive patients being treated for NMSC with Mohs surgery at a single center. The average age of the patients was 67 years; 58 identified as white Hispanic, 116 identified as white non-Hispanic.
White Hispanic patients had significantly lower skin cancer knowledge scores, compared with white non-Hispanics (P = .003). White Hispanics were significantly more likely than white non-Hispanics to report never wearing hats (39% vs. 12%) and never wearing sunglasses (26% vs. 9%) for sun protection.
The findings were limited by the study population that included only residents of South Florida. However, the results highlight the need for “targeted patient education initiatives to bridge ethnic disparities regarding cancer knowledge and ultimately improve [quality of life] among Hispanic skin cancer suffers,” the investigators concluded.
The study received no outside funding. The investigators declared no conflicts of interest.
SOURCE: Rajabi-Estarabadi A et al. J Am Acad Dermatol. 2020 Feb 4. doi: 10.1016/j.jaad.2020.01.063.
White Hispanic adults report a lower quality of life and less knowledge of skin cancer and sun protection behaviors than white non-Hispanic adults, survey results of 175 adults with nonmelanoma skin cancer show.
“The incidence of nonmelanoma skin cancer (NMSC) is lower in Hispanics when compared to Caucasians, but a high index of suspicion is needed given ethnic differences in presentation,” wrote Ali Rajabi-Estarabadi, MD, of the University of Miami, and colleagues.
Hispanic patients with NMSC tend to be younger than non-Hispanic white patients, and their basal cell carcinomas are more likely to be pigmented, the investigators noted. Although previous research suggests ethnic disparities in NMSC, factors including sun safety knowledge and quality of life after diagnosis have not been well studied, they said.
With this in mind, the investigators conducted a survey of white Hispanics and non-Hispanics treated for NMSC. The results were published as a research letter in the Journal of the American Academy of Dermatology.
The investigators recruited 175 consecutive patients being treated for NMSC with Mohs surgery at a single center. The average age of the patients was 67 years; 58 identified as white Hispanic, 116 identified as white non-Hispanic.
White Hispanic patients had significantly lower skin cancer knowledge scores, compared with white non-Hispanics (P = .003). White Hispanics were significantly more likely than white non-Hispanics to report never wearing hats (39% vs. 12%) and never wearing sunglasses (26% vs. 9%) for sun protection.
The findings were limited by the study population that included only residents of South Florida. However, the results highlight the need for “targeted patient education initiatives to bridge ethnic disparities regarding cancer knowledge and ultimately improve [quality of life] among Hispanic skin cancer suffers,” the investigators concluded.
The study received no outside funding. The investigators declared no conflicts of interest.
SOURCE: Rajabi-Estarabadi A et al. J Am Acad Dermatol. 2020 Feb 4. doi: 10.1016/j.jaad.2020.01.063.
White Hispanic adults report a lower quality of life and less knowledge of skin cancer and sun protection behaviors than white non-Hispanic adults, survey results of 175 adults with nonmelanoma skin cancer show.
“The incidence of nonmelanoma skin cancer (NMSC) is lower in Hispanics when compared to Caucasians, but a high index of suspicion is needed given ethnic differences in presentation,” wrote Ali Rajabi-Estarabadi, MD, of the University of Miami, and colleagues.
Hispanic patients with NMSC tend to be younger than non-Hispanic white patients, and their basal cell carcinomas are more likely to be pigmented, the investigators noted. Although previous research suggests ethnic disparities in NMSC, factors including sun safety knowledge and quality of life after diagnosis have not been well studied, they said.
With this in mind, the investigators conducted a survey of white Hispanics and non-Hispanics treated for NMSC. The results were published as a research letter in the Journal of the American Academy of Dermatology.
The investigators recruited 175 consecutive patients being treated for NMSC with Mohs surgery at a single center. The average age of the patients was 67 years; 58 identified as white Hispanic, 116 identified as white non-Hispanic.
White Hispanic patients had significantly lower skin cancer knowledge scores, compared with white non-Hispanics (P = .003). White Hispanics were significantly more likely than white non-Hispanics to report never wearing hats (39% vs. 12%) and never wearing sunglasses (26% vs. 9%) for sun protection.
The findings were limited by the study population that included only residents of South Florida. However, the results highlight the need for “targeted patient education initiatives to bridge ethnic disparities regarding cancer knowledge and ultimately improve [quality of life] among Hispanic skin cancer suffers,” the investigators concluded.
The study received no outside funding. The investigators declared no conflicts of interest.
SOURCE: Rajabi-Estarabadi A et al. J Am Acad Dermatol. 2020 Feb 4. doi: 10.1016/j.jaad.2020.01.063.
FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Racial disparities persist in preterm birth risk
Education, status are not protective for non-Hispanic black women
GRAPEVINE, TEX. – College education and high socioeconomic status do not erase U.S. racial disparities in birth outcomes, according to a new analysis of all U.S. live births from 2015-2017.
Very early preterm birth – birth before 28 weeks gestational age – was five times more likely to occur in non-Hispanic black women of high socioeconomic status as similarly situated white women, even after statistical adjustment for a host of potentially confounding factors.
Being of non-Hispanic black race was the single strongest predictor of preterm birth (PTB) at less than 28 weeks’ gestation. The adjusted odds ratio (aOR) of 4.99 surpassed an interpregnancy interval under 1 year (aOR, 4.47), chronic hypertension (aOR, 2.84), and prior history of preterm birth (aOR, 2.81).
“Even among college-educated women with private insurance who are not receiving (Women, Infants, and Children support), racial disparities in prematurity persist. These results suggest that factors other than sociodemographics are important in the underlying pathogenesis of PTB and in etiologies of racial disparities,” wrote Jasmine Johnson, MD, and her coauthors in the abstract accompanying the presentation at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The analysis that Dr. Johnson and her coinvestigators used, she explained during her plenary session presentation, still found significantly elevated risks for preterm birth for non-Hispanic black women after accounting for marital status, prior history of preterm birth, tobacco use, an interpregnancy interval of fewer than 12 months, and carrying a male fetus.
“Birth certificates do not inform the lived experiences of one’s self-identified race, and how that experience – or possibly just one’s identification with a particular racial group – may positively or negatively affect their clinical risk of preterm birth,” said Dr. Johnson. “In this study, as in others, race is a social construct. It’s a surrogate for social and societal racism that disproportionately affects birth outcomes of women of color.”
Using non-Hispanic white (NHW) women as a reference, women who described themselves as non-Hispanic black (NHB) had increased odds of preterm birth at 34 and 37 weeks gestation as well. Women identifying as both NHB and NHW had numerically elevated odds for preterm birth at all time points as well, but the odds at 37 weeks didn’t reach statistical significance.
The results were based on a retrospective population-based study of a cohort drawn from the National Vital Statistics birth certificate data of all live births in the United States between 2015 and 2017, explained Dr. Johnson, a maternal-fetal medicine fellow at the University of North Carolina, Chapel Hill. Drawing from a nationally representative sample and having a population-level design drawn were strengths of the study, she said.
Women with singleton pregnancies without anomalies who identified as NHB, NHW, or as both NHB and NHW were included if they also had high socioeconomic status. Including women who identify as both black and white was another strength of the study, Dr. Johnson added.
She explained that, for the purposes of the study, high socioeconomic status was defined as having 16 or more years of education and private insurance, and not receiving WIC benefits.
In addition to the primary outcome measure of preterm birth at fewer than 37 weeks gestation, secondary outcomes included preterm birth at fewer than 34 and fewer than 28 weeks’ gestation, as well as low birthweight (LBW) and very low birthweight (VLBW).
About 11.8 million live births occurred during the study period, and 11.3 million of those were singleton pregnancies without fetal anomaly. After excluding women who did not meet the racial self-identification or socioeconomic status inclusion criteria, the investigators arrived at the final study population of 2,170,688 individuals.
Of those, 2,017,470, or 92.9%, were non-Hispanic white, while 144,612, or 6.7%, were non-Hispanic black. The remaining 8,604 participants, or 0.4%, identified their race as non-Hispanic black and non-Hispanic white.
The groups identified in the study differed significantly in demographic characteristics, Dr. Johnson said. Women in the NHB and NHB + NHW groups were less likely to be married than NHW women – about 75% of the former two groups were married, compared with 92.5% of NHW women. This difference was statistically significant with a P value of .001, as were all the differences Dr. Johnson reported.
Pre-pregnancy body mass index (BMI) was highest in NHB women at 27.1 kg/m sq, followed by NHB = NHW women at 25.7 kg/m sq, with NHW women having the lowest BMI at 23.8 kg/m sq.
Prior preterm birth of 37 weeks’ gestation or less was more common in NHB women and NHB + NHW women, as was an interpregnancy interval of fewer than 12 months.
Chronic hypertension was more than twice as common in NHB women than in either NHB = NHW or NHW women, occurring in 3.9%, 1.8%, and 1.4% of participants, respectively.
Pregestational diabetes was about twice as common in NHB women than NHW women, occurring in 1% and 0.52% of those groups, respectively. Prevalence of pregestational diabetes was intermediate in NHB = NHW women, at 0.72%.
Tobacco use was rare overall, and less common in NHB women than NHB + NHW and NHW women.
In terms of pregnancy characteristics, though 85% of NHB women initiated prenatal care in the first trimester, they were less likely to have done so than either of the other two groups. Few women overall had no prenatal care, but 0.7% of NHB women fell into this category, more than the 0.4% and 0.3% reported for NHB + NHW and NHW women, respectively.
During their pregnancies, NHB women were more likely to develop gestational hypertension and/or pre-eclampsia as well as gestational diabetes than either of the other two groups (7.6% compared with 6% for the other two groups). Of the NHB women, 5.9% developed gestational diabetes, compared with 4.8% of NHB + NHW and 4.8% of NHW women.
Delivering a baby with a birthweight less than the 10th percentile was twice as common for NHB, compared with NHW women (7.2% versus 3.4%). The risk for NHB + NHW women was intermediate, at 4.7%.
Dr. Johnson said she and her team performed further analyses, including using initiation of prenatal care in the first trimester of pregnancy as a surrogate for high socioeconomic status; the association of race and risk for preterm birth persisted.
The study had the usual limitations of using National Vital Statistics data, such as the inability to evaluate underlying etiologies for preterm birth.
However, Dr. Johnson highlighted additional limitations that pertain to the experience of race in 21st century America. “Our definition of high socioeconomic status does not guarantee that all women in this analysis have financial stability,” she said, pointing out that the study’s definition of high socioeconomic status was insensitive to wealth accumulation. She also noted that high educational attainment does not necessarily correlate with high income. Hence, the potential burden of economic stressors could not fully be captured.
The study was supported by the National Institutes of Health. Dr. Johnson reported no conflicts of interest.
SOURCE: Johnson J et al. Obstet Gynecol. 2020 Jan;222(1):S-37-8, Abstract 44.
Education, status are not protective for non-Hispanic black women
Education, status are not protective for non-Hispanic black women
GRAPEVINE, TEX. – College education and high socioeconomic status do not erase U.S. racial disparities in birth outcomes, according to a new analysis of all U.S. live births from 2015-2017.
Very early preterm birth – birth before 28 weeks gestational age – was five times more likely to occur in non-Hispanic black women of high socioeconomic status as similarly situated white women, even after statistical adjustment for a host of potentially confounding factors.
Being of non-Hispanic black race was the single strongest predictor of preterm birth (PTB) at less than 28 weeks’ gestation. The adjusted odds ratio (aOR) of 4.99 surpassed an interpregnancy interval under 1 year (aOR, 4.47), chronic hypertension (aOR, 2.84), and prior history of preterm birth (aOR, 2.81).
“Even among college-educated women with private insurance who are not receiving (Women, Infants, and Children support), racial disparities in prematurity persist. These results suggest that factors other than sociodemographics are important in the underlying pathogenesis of PTB and in etiologies of racial disparities,” wrote Jasmine Johnson, MD, and her coauthors in the abstract accompanying the presentation at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The analysis that Dr. Johnson and her coinvestigators used, she explained during her plenary session presentation, still found significantly elevated risks for preterm birth for non-Hispanic black women after accounting for marital status, prior history of preterm birth, tobacco use, an interpregnancy interval of fewer than 12 months, and carrying a male fetus.
“Birth certificates do not inform the lived experiences of one’s self-identified race, and how that experience – or possibly just one’s identification with a particular racial group – may positively or negatively affect their clinical risk of preterm birth,” said Dr. Johnson. “In this study, as in others, race is a social construct. It’s a surrogate for social and societal racism that disproportionately affects birth outcomes of women of color.”
Using non-Hispanic white (NHW) women as a reference, women who described themselves as non-Hispanic black (NHB) had increased odds of preterm birth at 34 and 37 weeks gestation as well. Women identifying as both NHB and NHW had numerically elevated odds for preterm birth at all time points as well, but the odds at 37 weeks didn’t reach statistical significance.
The results were based on a retrospective population-based study of a cohort drawn from the National Vital Statistics birth certificate data of all live births in the United States between 2015 and 2017, explained Dr. Johnson, a maternal-fetal medicine fellow at the University of North Carolina, Chapel Hill. Drawing from a nationally representative sample and having a population-level design drawn were strengths of the study, she said.
Women with singleton pregnancies without anomalies who identified as NHB, NHW, or as both NHB and NHW were included if they also had high socioeconomic status. Including women who identify as both black and white was another strength of the study, Dr. Johnson added.
She explained that, for the purposes of the study, high socioeconomic status was defined as having 16 or more years of education and private insurance, and not receiving WIC benefits.
In addition to the primary outcome measure of preterm birth at fewer than 37 weeks gestation, secondary outcomes included preterm birth at fewer than 34 and fewer than 28 weeks’ gestation, as well as low birthweight (LBW) and very low birthweight (VLBW).
About 11.8 million live births occurred during the study period, and 11.3 million of those were singleton pregnancies without fetal anomaly. After excluding women who did not meet the racial self-identification or socioeconomic status inclusion criteria, the investigators arrived at the final study population of 2,170,688 individuals.
Of those, 2,017,470, or 92.9%, were non-Hispanic white, while 144,612, or 6.7%, were non-Hispanic black. The remaining 8,604 participants, or 0.4%, identified their race as non-Hispanic black and non-Hispanic white.
The groups identified in the study differed significantly in demographic characteristics, Dr. Johnson said. Women in the NHB and NHB + NHW groups were less likely to be married than NHW women – about 75% of the former two groups were married, compared with 92.5% of NHW women. This difference was statistically significant with a P value of .001, as were all the differences Dr. Johnson reported.
Pre-pregnancy body mass index (BMI) was highest in NHB women at 27.1 kg/m sq, followed by NHB = NHW women at 25.7 kg/m sq, with NHW women having the lowest BMI at 23.8 kg/m sq.
Prior preterm birth of 37 weeks’ gestation or less was more common in NHB women and NHB + NHW women, as was an interpregnancy interval of fewer than 12 months.
Chronic hypertension was more than twice as common in NHB women than in either NHB = NHW or NHW women, occurring in 3.9%, 1.8%, and 1.4% of participants, respectively.
Pregestational diabetes was about twice as common in NHB women than NHW women, occurring in 1% and 0.52% of those groups, respectively. Prevalence of pregestational diabetes was intermediate in NHB = NHW women, at 0.72%.
Tobacco use was rare overall, and less common in NHB women than NHB + NHW and NHW women.
In terms of pregnancy characteristics, though 85% of NHB women initiated prenatal care in the first trimester, they were less likely to have done so than either of the other two groups. Few women overall had no prenatal care, but 0.7% of NHB women fell into this category, more than the 0.4% and 0.3% reported for NHB + NHW and NHW women, respectively.
During their pregnancies, NHB women were more likely to develop gestational hypertension and/or pre-eclampsia as well as gestational diabetes than either of the other two groups (7.6% compared with 6% for the other two groups). Of the NHB women, 5.9% developed gestational diabetes, compared with 4.8% of NHB + NHW and 4.8% of NHW women.
Delivering a baby with a birthweight less than the 10th percentile was twice as common for NHB, compared with NHW women (7.2% versus 3.4%). The risk for NHB + NHW women was intermediate, at 4.7%.
Dr. Johnson said she and her team performed further analyses, including using initiation of prenatal care in the first trimester of pregnancy as a surrogate for high socioeconomic status; the association of race and risk for preterm birth persisted.
The study had the usual limitations of using National Vital Statistics data, such as the inability to evaluate underlying etiologies for preterm birth.
However, Dr. Johnson highlighted additional limitations that pertain to the experience of race in 21st century America. “Our definition of high socioeconomic status does not guarantee that all women in this analysis have financial stability,” she said, pointing out that the study’s definition of high socioeconomic status was insensitive to wealth accumulation. She also noted that high educational attainment does not necessarily correlate with high income. Hence, the potential burden of economic stressors could not fully be captured.
The study was supported by the National Institutes of Health. Dr. Johnson reported no conflicts of interest.
SOURCE: Johnson J et al. Obstet Gynecol. 2020 Jan;222(1):S-37-8, Abstract 44.
GRAPEVINE, TEX. – College education and high socioeconomic status do not erase U.S. racial disparities in birth outcomes, according to a new analysis of all U.S. live births from 2015-2017.
Very early preterm birth – birth before 28 weeks gestational age – was five times more likely to occur in non-Hispanic black women of high socioeconomic status as similarly situated white women, even after statistical adjustment for a host of potentially confounding factors.
Being of non-Hispanic black race was the single strongest predictor of preterm birth (PTB) at less than 28 weeks’ gestation. The adjusted odds ratio (aOR) of 4.99 surpassed an interpregnancy interval under 1 year (aOR, 4.47), chronic hypertension (aOR, 2.84), and prior history of preterm birth (aOR, 2.81).
“Even among college-educated women with private insurance who are not receiving (Women, Infants, and Children support), racial disparities in prematurity persist. These results suggest that factors other than sociodemographics are important in the underlying pathogenesis of PTB and in etiologies of racial disparities,” wrote Jasmine Johnson, MD, and her coauthors in the abstract accompanying the presentation at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The analysis that Dr. Johnson and her coinvestigators used, she explained during her plenary session presentation, still found significantly elevated risks for preterm birth for non-Hispanic black women after accounting for marital status, prior history of preterm birth, tobacco use, an interpregnancy interval of fewer than 12 months, and carrying a male fetus.
“Birth certificates do not inform the lived experiences of one’s self-identified race, and how that experience – or possibly just one’s identification with a particular racial group – may positively or negatively affect their clinical risk of preterm birth,” said Dr. Johnson. “In this study, as in others, race is a social construct. It’s a surrogate for social and societal racism that disproportionately affects birth outcomes of women of color.”
Using non-Hispanic white (NHW) women as a reference, women who described themselves as non-Hispanic black (NHB) had increased odds of preterm birth at 34 and 37 weeks gestation as well. Women identifying as both NHB and NHW had numerically elevated odds for preterm birth at all time points as well, but the odds at 37 weeks didn’t reach statistical significance.
The results were based on a retrospective population-based study of a cohort drawn from the National Vital Statistics birth certificate data of all live births in the United States between 2015 and 2017, explained Dr. Johnson, a maternal-fetal medicine fellow at the University of North Carolina, Chapel Hill. Drawing from a nationally representative sample and having a population-level design drawn were strengths of the study, she said.
Women with singleton pregnancies without anomalies who identified as NHB, NHW, or as both NHB and NHW were included if they also had high socioeconomic status. Including women who identify as both black and white was another strength of the study, Dr. Johnson added.
She explained that, for the purposes of the study, high socioeconomic status was defined as having 16 or more years of education and private insurance, and not receiving WIC benefits.
In addition to the primary outcome measure of preterm birth at fewer than 37 weeks gestation, secondary outcomes included preterm birth at fewer than 34 and fewer than 28 weeks’ gestation, as well as low birthweight (LBW) and very low birthweight (VLBW).
About 11.8 million live births occurred during the study period, and 11.3 million of those were singleton pregnancies without fetal anomaly. After excluding women who did not meet the racial self-identification or socioeconomic status inclusion criteria, the investigators arrived at the final study population of 2,170,688 individuals.
Of those, 2,017,470, or 92.9%, were non-Hispanic white, while 144,612, or 6.7%, were non-Hispanic black. The remaining 8,604 participants, or 0.4%, identified their race as non-Hispanic black and non-Hispanic white.
The groups identified in the study differed significantly in demographic characteristics, Dr. Johnson said. Women in the NHB and NHB + NHW groups were less likely to be married than NHW women – about 75% of the former two groups were married, compared with 92.5% of NHW women. This difference was statistically significant with a P value of .001, as were all the differences Dr. Johnson reported.
Pre-pregnancy body mass index (BMI) was highest in NHB women at 27.1 kg/m sq, followed by NHB = NHW women at 25.7 kg/m sq, with NHW women having the lowest BMI at 23.8 kg/m sq.
Prior preterm birth of 37 weeks’ gestation or less was more common in NHB women and NHB + NHW women, as was an interpregnancy interval of fewer than 12 months.
Chronic hypertension was more than twice as common in NHB women than in either NHB = NHW or NHW women, occurring in 3.9%, 1.8%, and 1.4% of participants, respectively.
Pregestational diabetes was about twice as common in NHB women than NHW women, occurring in 1% and 0.52% of those groups, respectively. Prevalence of pregestational diabetes was intermediate in NHB = NHW women, at 0.72%.
Tobacco use was rare overall, and less common in NHB women than NHB + NHW and NHW women.
In terms of pregnancy characteristics, though 85% of NHB women initiated prenatal care in the first trimester, they were less likely to have done so than either of the other two groups. Few women overall had no prenatal care, but 0.7% of NHB women fell into this category, more than the 0.4% and 0.3% reported for NHB + NHW and NHW women, respectively.
During their pregnancies, NHB women were more likely to develop gestational hypertension and/or pre-eclampsia as well as gestational diabetes than either of the other two groups (7.6% compared with 6% for the other two groups). Of the NHB women, 5.9% developed gestational diabetes, compared with 4.8% of NHB + NHW and 4.8% of NHW women.
Delivering a baby with a birthweight less than the 10th percentile was twice as common for NHB, compared with NHW women (7.2% versus 3.4%). The risk for NHB + NHW women was intermediate, at 4.7%.
Dr. Johnson said she and her team performed further analyses, including using initiation of prenatal care in the first trimester of pregnancy as a surrogate for high socioeconomic status; the association of race and risk for preterm birth persisted.
The study had the usual limitations of using National Vital Statistics data, such as the inability to evaluate underlying etiologies for preterm birth.
However, Dr. Johnson highlighted additional limitations that pertain to the experience of race in 21st century America. “Our definition of high socioeconomic status does not guarantee that all women in this analysis have financial stability,” she said, pointing out that the study’s definition of high socioeconomic status was insensitive to wealth accumulation. She also noted that high educational attainment does not necessarily correlate with high income. Hence, the potential burden of economic stressors could not fully be captured.
The study was supported by the National Institutes of Health. Dr. Johnson reported no conflicts of interest.
SOURCE: Johnson J et al. Obstet Gynecol. 2020 Jan;222(1):S-37-8, Abstract 44.
AT THE PREGNANCY MEETING
Glioma trials should track living well, not just longer
Neuro-oncology working group backs focus on how patients feel, function
Glioma treatment goals traditionally have focused on tumor shrinkage or prolonging survival, but it’s time for those endpoints to be supplemented by clinical outcomes that are meaningful to the patient, according to a recently published report from a neuro-oncology working group.
The group, which includes representatives of previous oncology working groups, the Food and Drug Administration, and observers from the European Medicines Agency, has established a core set of symptoms and functional points that they say could be used in clinical trials and clinical care for patients with high-grade gliomas.
“Patients want to live longer, but they also want to continue to function as well as possible for as long as possible,” said Terri S. Armstrong, PhD, of the National Cancer Institute (NCI), and coauthors in a report that sums up the work to date of the Fast Track COA Group.
That work, while specific to gliomas, echoes results from broader initiatives that seek to standardize patient-reported outcomes in oncology trials, Dr. Armstrong and coauthors wrote. The report was published in the Lancet Oncology.
The core set of symptom constructs and functional issues identified by the work group are represented already in patient-reported outcome measures, according to the authors.
The symptoms worth measuring fall into five categories, including pain, difficulty communicating, perceived cognition, seizures, and symptomatic adverse events. The functional issues were divided into two categories, physical functioning, including weakness or walking, and role functioning, which they defined as the ability to work or participate in social or leisure activities.
Some of those outcomes can be challenging or cumbersome to track, Dr. Armstrong and coauthors said.
Pain has “many dimensions“ and is important to track, the group wrote. Likewise, patients’ concerns related to language function also are important, but are very “noisy“ as a variable and can be specific to tumor location.
Collecting data on seizure frequency and severity is important yet complicated, because of the variability in seizures and considerable difference between focal and generalized seizures. Assessment of cognitive functioning can be lengthy and burdensome to patients.
Adverse events of relevance will vary, depending on the drug used, its mechanism of action, and available data, though some allowance needs to be made for the possibility of “overlap“ with disease-related symptoms, the report said.
Physical functioning, including walking and weakness, should be evaluated. It also would be useful to distinguish the duration of time that patients have deficits in physical functioning in the later stages of their disease progression, authors said.
Role and social functioning should be assessed in most patients with high-grade gliomas, who will have symptoms and deficits that prevent returning to a job. “Patients might spend a substantial portion of their lives feeling ill, unable to do usual activities, or meet occupational, social, financial, and family obligations,” said Dr. Armstrong and coauthors in the report.
The scales and tools used to measure symptoms and functional concerns need to be those that best fit a particular clinical trial or clinical practice scenario. Several instruments that would be appropriate are discussed in the report, including the NCI Patient-Reported Outcome of the Common Toxicity Criteria Adverse Events (NCI PRO-CTCAE) and symptom and function scales or items in the Patient-Reported Outcomes Measurement System (PROMIS).
, such as time to recurrence or survival.
“Strategies for introducing these constructs to clinical trial cooperative groups and sponsors will be necessary,” they concluded.
Dr. Armstrong reported employment as a senior investigator and deputy chief of the neuro-oncology branch of the Center for Cancer Research at the NCI. His coauthors reported disclosures related to several companies and interests, including AbbVie, AstraZeneca, Bristol-Myers Squibb, Genentech, Merck, Taiho, and Tocagen.
SOURCE: Armstrong TS et al. Lancet Oncol. 2020;21(2):e97-103.
Neuro-oncology working group backs focus on how patients feel, function
Neuro-oncology working group backs focus on how patients feel, function
Glioma treatment goals traditionally have focused on tumor shrinkage or prolonging survival, but it’s time for those endpoints to be supplemented by clinical outcomes that are meaningful to the patient, according to a recently published report from a neuro-oncology working group.
The group, which includes representatives of previous oncology working groups, the Food and Drug Administration, and observers from the European Medicines Agency, has established a core set of symptoms and functional points that they say could be used in clinical trials and clinical care for patients with high-grade gliomas.
“Patients want to live longer, but they also want to continue to function as well as possible for as long as possible,” said Terri S. Armstrong, PhD, of the National Cancer Institute (NCI), and coauthors in a report that sums up the work to date of the Fast Track COA Group.
That work, while specific to gliomas, echoes results from broader initiatives that seek to standardize patient-reported outcomes in oncology trials, Dr. Armstrong and coauthors wrote. The report was published in the Lancet Oncology.
The core set of symptom constructs and functional issues identified by the work group are represented already in patient-reported outcome measures, according to the authors.
The symptoms worth measuring fall into five categories, including pain, difficulty communicating, perceived cognition, seizures, and symptomatic adverse events. The functional issues were divided into two categories, physical functioning, including weakness or walking, and role functioning, which they defined as the ability to work or participate in social or leisure activities.
Some of those outcomes can be challenging or cumbersome to track, Dr. Armstrong and coauthors said.
Pain has “many dimensions“ and is important to track, the group wrote. Likewise, patients’ concerns related to language function also are important, but are very “noisy“ as a variable and can be specific to tumor location.
Collecting data on seizure frequency and severity is important yet complicated, because of the variability in seizures and considerable difference between focal and generalized seizures. Assessment of cognitive functioning can be lengthy and burdensome to patients.
Adverse events of relevance will vary, depending on the drug used, its mechanism of action, and available data, though some allowance needs to be made for the possibility of “overlap“ with disease-related symptoms, the report said.
Physical functioning, including walking and weakness, should be evaluated. It also would be useful to distinguish the duration of time that patients have deficits in physical functioning in the later stages of their disease progression, authors said.
Role and social functioning should be assessed in most patients with high-grade gliomas, who will have symptoms and deficits that prevent returning to a job. “Patients might spend a substantial portion of their lives feeling ill, unable to do usual activities, or meet occupational, social, financial, and family obligations,” said Dr. Armstrong and coauthors in the report.
The scales and tools used to measure symptoms and functional concerns need to be those that best fit a particular clinical trial or clinical practice scenario. Several instruments that would be appropriate are discussed in the report, including the NCI Patient-Reported Outcome of the Common Toxicity Criteria Adverse Events (NCI PRO-CTCAE) and symptom and function scales or items in the Patient-Reported Outcomes Measurement System (PROMIS).
, such as time to recurrence or survival.
“Strategies for introducing these constructs to clinical trial cooperative groups and sponsors will be necessary,” they concluded.
Dr. Armstrong reported employment as a senior investigator and deputy chief of the neuro-oncology branch of the Center for Cancer Research at the NCI. His coauthors reported disclosures related to several companies and interests, including AbbVie, AstraZeneca, Bristol-Myers Squibb, Genentech, Merck, Taiho, and Tocagen.
SOURCE: Armstrong TS et al. Lancet Oncol. 2020;21(2):e97-103.
Glioma treatment goals traditionally have focused on tumor shrinkage or prolonging survival, but it’s time for those endpoints to be supplemented by clinical outcomes that are meaningful to the patient, according to a recently published report from a neuro-oncology working group.
The group, which includes representatives of previous oncology working groups, the Food and Drug Administration, and observers from the European Medicines Agency, has established a core set of symptoms and functional points that they say could be used in clinical trials and clinical care for patients with high-grade gliomas.
“Patients want to live longer, but they also want to continue to function as well as possible for as long as possible,” said Terri S. Armstrong, PhD, of the National Cancer Institute (NCI), and coauthors in a report that sums up the work to date of the Fast Track COA Group.
That work, while specific to gliomas, echoes results from broader initiatives that seek to standardize patient-reported outcomes in oncology trials, Dr. Armstrong and coauthors wrote. The report was published in the Lancet Oncology.
The core set of symptom constructs and functional issues identified by the work group are represented already in patient-reported outcome measures, according to the authors.
The symptoms worth measuring fall into five categories, including pain, difficulty communicating, perceived cognition, seizures, and symptomatic adverse events. The functional issues were divided into two categories, physical functioning, including weakness or walking, and role functioning, which they defined as the ability to work or participate in social or leisure activities.
Some of those outcomes can be challenging or cumbersome to track, Dr. Armstrong and coauthors said.
Pain has “many dimensions“ and is important to track, the group wrote. Likewise, patients’ concerns related to language function also are important, but are very “noisy“ as a variable and can be specific to tumor location.
Collecting data on seizure frequency and severity is important yet complicated, because of the variability in seizures and considerable difference between focal and generalized seizures. Assessment of cognitive functioning can be lengthy and burdensome to patients.
Adverse events of relevance will vary, depending on the drug used, its mechanism of action, and available data, though some allowance needs to be made for the possibility of “overlap“ with disease-related symptoms, the report said.
Physical functioning, including walking and weakness, should be evaluated. It also would be useful to distinguish the duration of time that patients have deficits in physical functioning in the later stages of their disease progression, authors said.
Role and social functioning should be assessed in most patients with high-grade gliomas, who will have symptoms and deficits that prevent returning to a job. “Patients might spend a substantial portion of their lives feeling ill, unable to do usual activities, or meet occupational, social, financial, and family obligations,” said Dr. Armstrong and coauthors in the report.
The scales and tools used to measure symptoms and functional concerns need to be those that best fit a particular clinical trial or clinical practice scenario. Several instruments that would be appropriate are discussed in the report, including the NCI Patient-Reported Outcome of the Common Toxicity Criteria Adverse Events (NCI PRO-CTCAE) and symptom and function scales or items in the Patient-Reported Outcomes Measurement System (PROMIS).
, such as time to recurrence or survival.
“Strategies for introducing these constructs to clinical trial cooperative groups and sponsors will be necessary,” they concluded.
Dr. Armstrong reported employment as a senior investigator and deputy chief of the neuro-oncology branch of the Center for Cancer Research at the NCI. His coauthors reported disclosures related to several companies and interests, including AbbVie, AstraZeneca, Bristol-Myers Squibb, Genentech, Merck, Taiho, and Tocagen.
SOURCE: Armstrong TS et al. Lancet Oncol. 2020;21(2):e97-103.
FROM THE LANCET ONCOLOGY
Shift in approach is encouraged in assessing chronic pain
In many cases, dietary interventions can lead to less inflammation
SAN DIEGO – When clinicians ask patients to quantify their level of chronic pain on a scale of 1-10, and they rate it as a 7, what does that really mean?
Robert A. Bonakdar, MD, said posing such a question as the main determinator of the treatment approach during a pain assessment “depersonalizes medicine to the point where you’re making a patient a number.” Dr. Bonakdar spoke at Natural Supplements: An Evidence-Based Update, presented by Scripps Center for Integrative Medicine.
“It considers areas that are often overlooked, such as the role of the gut microbiome, mood, and epigenetics.”
Over the past two decades, the number of American adults suffering from pain has increased from 120 million to 178 million, or to 41% of the adult population, said Dr. Bonakdar, a family physician who is director of pain management at the Scripps Center for Integrative Medicine. Data from the National Institutes of Health estimate that Americans spend more than $600 billion each year on the treatment of pain, which surpasses monies spent on cancer, heart disease, and diabetes. According to a 2016 report from the United States Bone and Joint Initiative, arthritis and rheumatologic conditions resulted in an estimated 6.7 million annual hospitalizations, and the average annual cost per person for treatment of a musculoskeletal condition is $7,800.
“If we continue on our current trajectory, we are choosing to accept more prevalence and incidence of these disorders, spiraling costs, restricted access to needed services, and less success in alleviating pain and suffering – a high cost,” Edward H. Yelin, PhD, cochair of the report’s steering committee, and professor of medicine and health policy at the University of California, San Francisco, said in a prepared statement in 2016. That same year, Brian F. Mandell, MD, PhD, editor of the Cleveland Clinic Journal of Medicine, penned an editorial in which he stated that “The time has come to move past using a one-size-fits-all fifth vital sign . . . and reflexively prescribing an opioid when pain is characterized as severe” (Clev Clin J Med. 2016. Jun;83[6]:400-1). A decade earlier, authors of a cross-sectional review at a single Department of Veterans Affairs medical center set out to assess the impact of the VA’s “Pain as the 5th Vital Sign” initiative on the quality of pain management (J Gen Intern Med. 2006;21[6]:607–12). They found that patients with substantial pain documented by the fifth vital sign often had inadequate pain management. The preponderance of existing evidence suggests that a different approach is needed to prescribing opioids, Dr. Bonakdar said. “It’s coming from every voice in pain care: that what we are doing is not working,” he said. “It’s not only not working; it’s dangerous. That’s the consequence of depersonalized medicine. What’s the consequence of depersonalized nutrition? It’s the same industrialized approach.”
The typical American diet, he continued, is rife with processed foods and lacks an adequate proportion of plant-based products. “It’s basically a setup for inflammation,” Dr. Bonakdar said. “Most people who come into our clinic are eating 63% processed foods, 25% animal foods, and 12% plant foods. When we are eating, we’re oversizing it because that’s the American thing to do. At the end of the day, this process is not only killing us from heart disease and stroke as causes of death, but it’s also killing us as far as pain. The same diet that’s causing heart disease is the same diet that’s increasing pain.”
Dr. Bonakdar said that the ingestion of ultra-processed foods over time jumpstarts the process of dysbiosis, which increases gut permeability. “When gut permeability happens, and you have high levels of polysaccharides and inflammatory markers such as zonulin and lipopolysaccharide (LPS), it not only goes on to affect adipose tissue and insulin resistance, it can affect the muscle and joints,” he explained. “That is a setup for sarcopenia, or muscle loss, which then makes it harder for patients to be fully functional and active. It goes on to cause joint problems as well.”
He likened an increase in gut permeability to “a bomb going off in the gut.” Routine consumption of highly processed foods “creates this wave of inflammation that goes throughout your body affecting joints and muscles, and causes an increased amount of pain. Over time, patients make the connection but it’s much easier to say, ‘take this NSAID’ or ‘take this Cox-2 inhibitor’ to suppress the pain. But if all you’re doing is suppressing, you’re not going to the source of the pain.”
Dr. Bonakdar cited several recent articles that help to make the connection between dysbiosis and pain, including a review that concluded that dysbiosis of gut microbiota can influence the onset and progression of chronic degenerative diseases (Nutrients. 2019;11[8]:1707). Authors of a separate review concluded that human microbiome studies strongly suggest an incriminating role of microbes in the pathophysiology and progression of RA. Lastly, several studies have noted that pain conditions such as fibromyalgia may have microbiome “signatures” related to dysbiosis, which may pave the way for interventions, such as dietary shifting and probiotics that target individuals with microbiome abnormalities (Pain. 2019 Nov;160[11]:2589-602 and EBioMedicine. 2019 Aug 1;46:499-511).
Clinicians can begin to help patients who present with pain complaints “by listening to what their current pattern is: strategies that have worked, and those that haven’t,” he said. “If we’re not understanding the person and we’re just ordering genetic studies or microbiome studies and going off of the assessment, we sometime miss what interventions to start. In many cases, a simple intervention like a dietary shift is all that’s required.”
A survey of more than 1 million individuals found that BMI and daily pain are positively correlated in the United States (Obesity 2012;20[7]:1491-5). “This is increased more significantly for women and the elderly,” said Dr. Bonakdar, who was not affiliated with the study. “If we can change the diet that person is taking, that’s going to begin the process of reversing this to the point where they’re having less pain from inflammation that’s affecting the adipose tissue and adipokines traveling to their joints, which can cause less dysbiosis. It is very much a vicious cycle that patients follow, but if you begin to unwind it, it’s going to help multiple areas.”
In the Intensive Diet and Exercise for Arthritis (IDEA) trial, researchers randomized 450 patients with osteoarthritis to intensive dietary restriction only, exercise only, or a combination of both (BMC Musculoskelet Disord. 2009;10:93). They found that a 5% weight loss over the course of 18 months led to a 30% reduction in pain and a 24% improvement in function.
Inspired by the IDEA trial design, Dr. Bonakdar and his colleagues completed an unpublished 12-week pilot program with 12 patients with a BMI of 27 kg/m2 or greater plus comorbidities. The program consisted of weekly group meetings, including a lecture by team clinicians, dietician, and fitness staff; group support sessions with a behavioral counselor; and a group exercise session. It also included weekly 1:1 personal training sessions and biweekly 1:1 dietitian meetings. The researchers also evaluated several deficiencies linked to pain, including magnesium, vitamin D, vitamins B1, B2, and B12, folate, calcium, amino acids, omega 3s, zinc, coenzyme Q10, carnitine, and vitamin C. The goal was a weight reduction of 5%.
The intervention consisted of a 28-day detox/protein shake consumed 1-3 times per day, which contained 17 g of protein per serving. Nutritional supplementation was added based on results of individual diagnostics.
According to preliminary results from the trial, the intended weight goal was achieved. “More importantly, there were significant improvements in markers of dysbiosis, including zonulin and lipopolysaccharide, as well as the adipokine leptin, which appeared to be associated with improvement in quality of life measures and pain,” Dr. Bonakdar said.
He concluded his presentation by highlighting a pilot study conducted in an Australian tertiary pain clinic. It found that a personalized dietitian-delivered dietary intervention can improve pain scores, quality of life, and dietary intake of people experiencing chronic pain (Nutrients. 2019 Jan 16;11[1] pii: E181). “This is another piece of the puzzle showing that these dietary interventions can be done in multiple settings, including tertiary centers with nutrition staff, and that this important step can improve pain and quality of life,” he said.
Dr. Bonakdar disclosed that he receives royalties from Oxford University Press, Lippincott, and Elsevier. He is also a consultant to Standard Process.
dbrunk@mdedge.com
In many cases, dietary interventions can lead to less inflammation
In many cases, dietary interventions can lead to less inflammation
SAN DIEGO – When clinicians ask patients to quantify their level of chronic pain on a scale of 1-10, and they rate it as a 7, what does that really mean?
Robert A. Bonakdar, MD, said posing such a question as the main determinator of the treatment approach during a pain assessment “depersonalizes medicine to the point where you’re making a patient a number.” Dr. Bonakdar spoke at Natural Supplements: An Evidence-Based Update, presented by Scripps Center for Integrative Medicine.
“It considers areas that are often overlooked, such as the role of the gut microbiome, mood, and epigenetics.”
Over the past two decades, the number of American adults suffering from pain has increased from 120 million to 178 million, or to 41% of the adult population, said Dr. Bonakdar, a family physician who is director of pain management at the Scripps Center for Integrative Medicine. Data from the National Institutes of Health estimate that Americans spend more than $600 billion each year on the treatment of pain, which surpasses monies spent on cancer, heart disease, and diabetes. According to a 2016 report from the United States Bone and Joint Initiative, arthritis and rheumatologic conditions resulted in an estimated 6.7 million annual hospitalizations, and the average annual cost per person for treatment of a musculoskeletal condition is $7,800.
“If we continue on our current trajectory, we are choosing to accept more prevalence and incidence of these disorders, spiraling costs, restricted access to needed services, and less success in alleviating pain and suffering – a high cost,” Edward H. Yelin, PhD, cochair of the report’s steering committee, and professor of medicine and health policy at the University of California, San Francisco, said in a prepared statement in 2016. That same year, Brian F. Mandell, MD, PhD, editor of the Cleveland Clinic Journal of Medicine, penned an editorial in which he stated that “The time has come to move past using a one-size-fits-all fifth vital sign . . . and reflexively prescribing an opioid when pain is characterized as severe” (Clev Clin J Med. 2016. Jun;83[6]:400-1). A decade earlier, authors of a cross-sectional review at a single Department of Veterans Affairs medical center set out to assess the impact of the VA’s “Pain as the 5th Vital Sign” initiative on the quality of pain management (J Gen Intern Med. 2006;21[6]:607–12). They found that patients with substantial pain documented by the fifth vital sign often had inadequate pain management. The preponderance of existing evidence suggests that a different approach is needed to prescribing opioids, Dr. Bonakdar said. “It’s coming from every voice in pain care: that what we are doing is not working,” he said. “It’s not only not working; it’s dangerous. That’s the consequence of depersonalized medicine. What’s the consequence of depersonalized nutrition? It’s the same industrialized approach.”
The typical American diet, he continued, is rife with processed foods and lacks an adequate proportion of plant-based products. “It’s basically a setup for inflammation,” Dr. Bonakdar said. “Most people who come into our clinic are eating 63% processed foods, 25% animal foods, and 12% plant foods. When we are eating, we’re oversizing it because that’s the American thing to do. At the end of the day, this process is not only killing us from heart disease and stroke as causes of death, but it’s also killing us as far as pain. The same diet that’s causing heart disease is the same diet that’s increasing pain.”
Dr. Bonakdar said that the ingestion of ultra-processed foods over time jumpstarts the process of dysbiosis, which increases gut permeability. “When gut permeability happens, and you have high levels of polysaccharides and inflammatory markers such as zonulin and lipopolysaccharide (LPS), it not only goes on to affect adipose tissue and insulin resistance, it can affect the muscle and joints,” he explained. “That is a setup for sarcopenia, or muscle loss, which then makes it harder for patients to be fully functional and active. It goes on to cause joint problems as well.”
He likened an increase in gut permeability to “a bomb going off in the gut.” Routine consumption of highly processed foods “creates this wave of inflammation that goes throughout your body affecting joints and muscles, and causes an increased amount of pain. Over time, patients make the connection but it’s much easier to say, ‘take this NSAID’ or ‘take this Cox-2 inhibitor’ to suppress the pain. But if all you’re doing is suppressing, you’re not going to the source of the pain.”
Dr. Bonakdar cited several recent articles that help to make the connection between dysbiosis and pain, including a review that concluded that dysbiosis of gut microbiota can influence the onset and progression of chronic degenerative diseases (Nutrients. 2019;11[8]:1707). Authors of a separate review concluded that human microbiome studies strongly suggest an incriminating role of microbes in the pathophysiology and progression of RA. Lastly, several studies have noted that pain conditions such as fibromyalgia may have microbiome “signatures” related to dysbiosis, which may pave the way for interventions, such as dietary shifting and probiotics that target individuals with microbiome abnormalities (Pain. 2019 Nov;160[11]:2589-602 and EBioMedicine. 2019 Aug 1;46:499-511).
Clinicians can begin to help patients who present with pain complaints “by listening to what their current pattern is: strategies that have worked, and those that haven’t,” he said. “If we’re not understanding the person and we’re just ordering genetic studies or microbiome studies and going off of the assessment, we sometime miss what interventions to start. In many cases, a simple intervention like a dietary shift is all that’s required.”
A survey of more than 1 million individuals found that BMI and daily pain are positively correlated in the United States (Obesity 2012;20[7]:1491-5). “This is increased more significantly for women and the elderly,” said Dr. Bonakdar, who was not affiliated with the study. “If we can change the diet that person is taking, that’s going to begin the process of reversing this to the point where they’re having less pain from inflammation that’s affecting the adipose tissue and adipokines traveling to their joints, which can cause less dysbiosis. It is very much a vicious cycle that patients follow, but if you begin to unwind it, it’s going to help multiple areas.”
In the Intensive Diet and Exercise for Arthritis (IDEA) trial, researchers randomized 450 patients with osteoarthritis to intensive dietary restriction only, exercise only, or a combination of both (BMC Musculoskelet Disord. 2009;10:93). They found that a 5% weight loss over the course of 18 months led to a 30% reduction in pain and a 24% improvement in function.
Inspired by the IDEA trial design, Dr. Bonakdar and his colleagues completed an unpublished 12-week pilot program with 12 patients with a BMI of 27 kg/m2 or greater plus comorbidities. The program consisted of weekly group meetings, including a lecture by team clinicians, dietician, and fitness staff; group support sessions with a behavioral counselor; and a group exercise session. It also included weekly 1:1 personal training sessions and biweekly 1:1 dietitian meetings. The researchers also evaluated several deficiencies linked to pain, including magnesium, vitamin D, vitamins B1, B2, and B12, folate, calcium, amino acids, omega 3s, zinc, coenzyme Q10, carnitine, and vitamin C. The goal was a weight reduction of 5%.
The intervention consisted of a 28-day detox/protein shake consumed 1-3 times per day, which contained 17 g of protein per serving. Nutritional supplementation was added based on results of individual diagnostics.
According to preliminary results from the trial, the intended weight goal was achieved. “More importantly, there were significant improvements in markers of dysbiosis, including zonulin and lipopolysaccharide, as well as the adipokine leptin, which appeared to be associated with improvement in quality of life measures and pain,” Dr. Bonakdar said.
He concluded his presentation by highlighting a pilot study conducted in an Australian tertiary pain clinic. It found that a personalized dietitian-delivered dietary intervention can improve pain scores, quality of life, and dietary intake of people experiencing chronic pain (Nutrients. 2019 Jan 16;11[1] pii: E181). “This is another piece of the puzzle showing that these dietary interventions can be done in multiple settings, including tertiary centers with nutrition staff, and that this important step can improve pain and quality of life,” he said.
Dr. Bonakdar disclosed that he receives royalties from Oxford University Press, Lippincott, and Elsevier. He is also a consultant to Standard Process.
dbrunk@mdedge.com
SAN DIEGO – When clinicians ask patients to quantify their level of chronic pain on a scale of 1-10, and they rate it as a 7, what does that really mean?
Robert A. Bonakdar, MD, said posing such a question as the main determinator of the treatment approach during a pain assessment “depersonalizes medicine to the point where you’re making a patient a number.” Dr. Bonakdar spoke at Natural Supplements: An Evidence-Based Update, presented by Scripps Center for Integrative Medicine.
“It considers areas that are often overlooked, such as the role of the gut microbiome, mood, and epigenetics.”
Over the past two decades, the number of American adults suffering from pain has increased from 120 million to 178 million, or to 41% of the adult population, said Dr. Bonakdar, a family physician who is director of pain management at the Scripps Center for Integrative Medicine. Data from the National Institutes of Health estimate that Americans spend more than $600 billion each year on the treatment of pain, which surpasses monies spent on cancer, heart disease, and diabetes. According to a 2016 report from the United States Bone and Joint Initiative, arthritis and rheumatologic conditions resulted in an estimated 6.7 million annual hospitalizations, and the average annual cost per person for treatment of a musculoskeletal condition is $7,800.
“If we continue on our current trajectory, we are choosing to accept more prevalence and incidence of these disorders, spiraling costs, restricted access to needed services, and less success in alleviating pain and suffering – a high cost,” Edward H. Yelin, PhD, cochair of the report’s steering committee, and professor of medicine and health policy at the University of California, San Francisco, said in a prepared statement in 2016. That same year, Brian F. Mandell, MD, PhD, editor of the Cleveland Clinic Journal of Medicine, penned an editorial in which he stated that “The time has come to move past using a one-size-fits-all fifth vital sign . . . and reflexively prescribing an opioid when pain is characterized as severe” (Clev Clin J Med. 2016. Jun;83[6]:400-1). A decade earlier, authors of a cross-sectional review at a single Department of Veterans Affairs medical center set out to assess the impact of the VA’s “Pain as the 5th Vital Sign” initiative on the quality of pain management (J Gen Intern Med. 2006;21[6]:607–12). They found that patients with substantial pain documented by the fifth vital sign often had inadequate pain management. The preponderance of existing evidence suggests that a different approach is needed to prescribing opioids, Dr. Bonakdar said. “It’s coming from every voice in pain care: that what we are doing is not working,” he said. “It’s not only not working; it’s dangerous. That’s the consequence of depersonalized medicine. What’s the consequence of depersonalized nutrition? It’s the same industrialized approach.”
The typical American diet, he continued, is rife with processed foods and lacks an adequate proportion of plant-based products. “It’s basically a setup for inflammation,” Dr. Bonakdar said. “Most people who come into our clinic are eating 63% processed foods, 25% animal foods, and 12% plant foods. When we are eating, we’re oversizing it because that’s the American thing to do. At the end of the day, this process is not only killing us from heart disease and stroke as causes of death, but it’s also killing us as far as pain. The same diet that’s causing heart disease is the same diet that’s increasing pain.”
Dr. Bonakdar said that the ingestion of ultra-processed foods over time jumpstarts the process of dysbiosis, which increases gut permeability. “When gut permeability happens, and you have high levels of polysaccharides and inflammatory markers such as zonulin and lipopolysaccharide (LPS), it not only goes on to affect adipose tissue and insulin resistance, it can affect the muscle and joints,” he explained. “That is a setup for sarcopenia, or muscle loss, which then makes it harder for patients to be fully functional and active. It goes on to cause joint problems as well.”
He likened an increase in gut permeability to “a bomb going off in the gut.” Routine consumption of highly processed foods “creates this wave of inflammation that goes throughout your body affecting joints and muscles, and causes an increased amount of pain. Over time, patients make the connection but it’s much easier to say, ‘take this NSAID’ or ‘take this Cox-2 inhibitor’ to suppress the pain. But if all you’re doing is suppressing, you’re not going to the source of the pain.”
Dr. Bonakdar cited several recent articles that help to make the connection between dysbiosis and pain, including a review that concluded that dysbiosis of gut microbiota can influence the onset and progression of chronic degenerative diseases (Nutrients. 2019;11[8]:1707). Authors of a separate review concluded that human microbiome studies strongly suggest an incriminating role of microbes in the pathophysiology and progression of RA. Lastly, several studies have noted that pain conditions such as fibromyalgia may have microbiome “signatures” related to dysbiosis, which may pave the way for interventions, such as dietary shifting and probiotics that target individuals with microbiome abnormalities (Pain. 2019 Nov;160[11]:2589-602 and EBioMedicine. 2019 Aug 1;46:499-511).
Clinicians can begin to help patients who present with pain complaints “by listening to what their current pattern is: strategies that have worked, and those that haven’t,” he said. “If we’re not understanding the person and we’re just ordering genetic studies or microbiome studies and going off of the assessment, we sometime miss what interventions to start. In many cases, a simple intervention like a dietary shift is all that’s required.”
A survey of more than 1 million individuals found that BMI and daily pain are positively correlated in the United States (Obesity 2012;20[7]:1491-5). “This is increased more significantly for women and the elderly,” said Dr. Bonakdar, who was not affiliated with the study. “If we can change the diet that person is taking, that’s going to begin the process of reversing this to the point where they’re having less pain from inflammation that’s affecting the adipose tissue and adipokines traveling to their joints, which can cause less dysbiosis. It is very much a vicious cycle that patients follow, but if you begin to unwind it, it’s going to help multiple areas.”
In the Intensive Diet and Exercise for Arthritis (IDEA) trial, researchers randomized 450 patients with osteoarthritis to intensive dietary restriction only, exercise only, or a combination of both (BMC Musculoskelet Disord. 2009;10:93). They found that a 5% weight loss over the course of 18 months led to a 30% reduction in pain and a 24% improvement in function.
Inspired by the IDEA trial design, Dr. Bonakdar and his colleagues completed an unpublished 12-week pilot program with 12 patients with a BMI of 27 kg/m2 or greater plus comorbidities. The program consisted of weekly group meetings, including a lecture by team clinicians, dietician, and fitness staff; group support sessions with a behavioral counselor; and a group exercise session. It also included weekly 1:1 personal training sessions and biweekly 1:1 dietitian meetings. The researchers also evaluated several deficiencies linked to pain, including magnesium, vitamin D, vitamins B1, B2, and B12, folate, calcium, amino acids, omega 3s, zinc, coenzyme Q10, carnitine, and vitamin C. The goal was a weight reduction of 5%.
The intervention consisted of a 28-day detox/protein shake consumed 1-3 times per day, which contained 17 g of protein per serving. Nutritional supplementation was added based on results of individual diagnostics.
According to preliminary results from the trial, the intended weight goal was achieved. “More importantly, there were significant improvements in markers of dysbiosis, including zonulin and lipopolysaccharide, as well as the adipokine leptin, which appeared to be associated with improvement in quality of life measures and pain,” Dr. Bonakdar said.
He concluded his presentation by highlighting a pilot study conducted in an Australian tertiary pain clinic. It found that a personalized dietitian-delivered dietary intervention can improve pain scores, quality of life, and dietary intake of people experiencing chronic pain (Nutrients. 2019 Jan 16;11[1] pii: E181). “This is another piece of the puzzle showing that these dietary interventions can be done in multiple settings, including tertiary centers with nutrition staff, and that this important step can improve pain and quality of life,” he said.
Dr. Bonakdar disclosed that he receives royalties from Oxford University Press, Lippincott, and Elsevier. He is also a consultant to Standard Process.
dbrunk@mdedge.com
REPORTING FROM A NATURAL SUPPLEMENTS UPDATE
Primary care can embrace gender-affirming policies, approaches
In a new “blueprint” for practices planning to implement a transgender care program, Anna M. Morenz, MD, and her coauthors emphasized that more than technical skills are needed to build an effective and welcoming transgender health practice.
All patient-facing staff – from schedulers and receptionists to nurses and billers – should “receive a foundational level of training in cultural sensitivity and effective communication with transgender and gender-diverse persons,” they wrote. In addition, they emphasized, “the workplace culture must ensure that chatter behind closed doors does not differ from patient-facing language.”
One thing that’s become clear over time, noted the authors of the blueprint, is that transgender care is no longer limited to the endocrinologist’s office. “After years of referring transgender and gender-diverse patients to specialty clinics and endocrinologists, transgender health experts have come to agree that gender-affirming hormone therapy can be safely delivered as part of routine care by a trained primary care clinician,” wrote Dr. Morenz, an internal medicine resident at the University of Washington, Seattle, and her coauthors.
Nor do most adults receiving gender-affirming care require mental health services, unless the patient or the primary care clinician sees a need or utility for psychological care. The blueprint was published in the Annals of Family Medicine.
The first step to setting up transgender services within a primary care practice is to conduct a needs assessment, suggested Dr. Morenz and her colleagues. Whether in-person focus groups or online surveys or questionnaires are best might depend on the community climate, they wrote. When stigma is high, the opportunity for anonymity might provide more robust results. Other considerations include whether there’s a concentration of transgender people with particularly high need or risk in the community – for example, transgender women of color, who might be at higher risk of HIV/AIDS than the general population. Depending on the needs of a particular community, initial transgender care efforts may have a focus on such a population.
A practice also should conduct a realistic appraisal of its own strengths and areas of weakness: Is signage inclusive? Do intake forms afford flexibility in gender and pronoun preference? Are front office staff comfortable greeting members of the lesbian-gay-bisexual-transgender-queer-intersex-asexual (LGBTQIA) community? What about restroom signage – is there a gender-inclusive option?
Competent provision of trauma-informed care goes hand in hand with assessment and preparation for providing transgender care, noted the blueprint authors, because “transgender and gender-diverse people experience high levels of trauma and stress related to minority status.”
Performing outreach within an organization and community also can unearth existing services, so that a primary care transgender practice dovetails with and complements those ongoing efforts, avoiding unnecessarily duplicative services. “All transgender health programs can benefit from developing broad relationships with external agencies, community-based organizatons, and individual practitioners who provide a range of services and can function as a network for knowledge-sharing and referrals,” noted Dr. Morenz and her coauthors.
“Starting a new program, especially one focused on a stigmatized population, can generate staff concerns and resistance,” acknowledged Dr. Morenz and her colleagues. Efforts at getting organizational buy-in can emphasize that providing transgender care helps meet ethical obligations within medicine. Emphasizing that making such care available is really at the vanguard of best practices might help overcome some resistance, they said.
, with at least one champion having a leadership role within the organization, wrote Dr. Morenz and her colleagues.
A variety of care models can work when a practice is initiating transgender care, depending on community needs, internal resources, and the commitment level of various stakeholders. An evening clinic staffed by a small number of clinicians can be a good way to test the waters in some cases. Other facilities might wish to identify clinicians who are competent to offer hormone therapy, while still other clinics might be able to incorporate transgender care more globally within their practice. Regardless of which service model a practice opts for, however, it’s crucial to have staff members who are savvy navigators of insurance reimbursement for gender-affirming care.
And when transgender care is nested within a practice, those patients must not feel like second-class citizens of the clinic, or that they’re receiving care that’s somehow different or substandard. For example, wrote Dr. Morenz and her coauthors, a facility must consider what will happen when a transgender patient presents for urgent health needs and the primary care clinician is not available.
The nuts and bolts of providing safe and effective gender-affirming hormone therapy, said the blueprint authors, can be mastered with training and practice. “Despite common concerns that transgender health care is complicated, it is in fact as straightforward as managing common chronic diseases.”
The first step, they said, is providing risk-benefit education and counseling to patients, and reviewing fertility preservation considerations and options. Then, either estradiol or testosterone is initiated; Further suppression of endogenous hormones also might be indicated in feminization therapy in particular. The authors provided several continuing education resources for clinicians and other health care team members, and noted that a “train the trainer” model can prove effective, with a core team training others once they’ve become comfortable with the ins and outs of hormone prescribing and monitoring.
Having a staff that looks like the patient panel can go a long way toward promoting authentic inclusivity, but Dr. Morenz and her colleagues cautioned against hiring practices that amount to tokenism, or expecting transgender or gender-diverse staff to be ambassadors or spokespeople for others.
Taken together, the start-up costs for providing transgender care can be “minimal,” wrote the blueprint authors, because many free and low-cost educational resources are available. Some of the only real outlays may come from altering restroom signage and tweaking the electronic health record to accommodate gender diversity.
A practice that goes forward with transgender care, they conclude, “will provide a unique opportunity to holistically improve wellness and quality of life for transgender and gender-diverse people,” joining the “growing and passionate network of clinical practice teams who are committed to health care, innovation, and equity for transgender and gender-diverse communities.”
Dr. Morenz reported no outside sources of funding and reported that she has no relevant conflicts of interest.
SOURCE: Morenz AM et al. Ann Fam Med. 2020 Jan;18(1):73-9.
In a new “blueprint” for practices planning to implement a transgender care program, Anna M. Morenz, MD, and her coauthors emphasized that more than technical skills are needed to build an effective and welcoming transgender health practice.
All patient-facing staff – from schedulers and receptionists to nurses and billers – should “receive a foundational level of training in cultural sensitivity and effective communication with transgender and gender-diverse persons,” they wrote. In addition, they emphasized, “the workplace culture must ensure that chatter behind closed doors does not differ from patient-facing language.”
One thing that’s become clear over time, noted the authors of the blueprint, is that transgender care is no longer limited to the endocrinologist’s office. “After years of referring transgender and gender-diverse patients to specialty clinics and endocrinologists, transgender health experts have come to agree that gender-affirming hormone therapy can be safely delivered as part of routine care by a trained primary care clinician,” wrote Dr. Morenz, an internal medicine resident at the University of Washington, Seattle, and her coauthors.
Nor do most adults receiving gender-affirming care require mental health services, unless the patient or the primary care clinician sees a need or utility for psychological care. The blueprint was published in the Annals of Family Medicine.
The first step to setting up transgender services within a primary care practice is to conduct a needs assessment, suggested Dr. Morenz and her colleagues. Whether in-person focus groups or online surveys or questionnaires are best might depend on the community climate, they wrote. When stigma is high, the opportunity for anonymity might provide more robust results. Other considerations include whether there’s a concentration of transgender people with particularly high need or risk in the community – for example, transgender women of color, who might be at higher risk of HIV/AIDS than the general population. Depending on the needs of a particular community, initial transgender care efforts may have a focus on such a population.
A practice also should conduct a realistic appraisal of its own strengths and areas of weakness: Is signage inclusive? Do intake forms afford flexibility in gender and pronoun preference? Are front office staff comfortable greeting members of the lesbian-gay-bisexual-transgender-queer-intersex-asexual (LGBTQIA) community? What about restroom signage – is there a gender-inclusive option?
Competent provision of trauma-informed care goes hand in hand with assessment and preparation for providing transgender care, noted the blueprint authors, because “transgender and gender-diverse people experience high levels of trauma and stress related to minority status.”
Performing outreach within an organization and community also can unearth existing services, so that a primary care transgender practice dovetails with and complements those ongoing efforts, avoiding unnecessarily duplicative services. “All transgender health programs can benefit from developing broad relationships with external agencies, community-based organizatons, and individual practitioners who provide a range of services and can function as a network for knowledge-sharing and referrals,” noted Dr. Morenz and her coauthors.
“Starting a new program, especially one focused on a stigmatized population, can generate staff concerns and resistance,” acknowledged Dr. Morenz and her colleagues. Efforts at getting organizational buy-in can emphasize that providing transgender care helps meet ethical obligations within medicine. Emphasizing that making such care available is really at the vanguard of best practices might help overcome some resistance, they said.
, with at least one champion having a leadership role within the organization, wrote Dr. Morenz and her colleagues.
A variety of care models can work when a practice is initiating transgender care, depending on community needs, internal resources, and the commitment level of various stakeholders. An evening clinic staffed by a small number of clinicians can be a good way to test the waters in some cases. Other facilities might wish to identify clinicians who are competent to offer hormone therapy, while still other clinics might be able to incorporate transgender care more globally within their practice. Regardless of which service model a practice opts for, however, it’s crucial to have staff members who are savvy navigators of insurance reimbursement for gender-affirming care.
And when transgender care is nested within a practice, those patients must not feel like second-class citizens of the clinic, or that they’re receiving care that’s somehow different or substandard. For example, wrote Dr. Morenz and her coauthors, a facility must consider what will happen when a transgender patient presents for urgent health needs and the primary care clinician is not available.
The nuts and bolts of providing safe and effective gender-affirming hormone therapy, said the blueprint authors, can be mastered with training and practice. “Despite common concerns that transgender health care is complicated, it is in fact as straightforward as managing common chronic diseases.”
The first step, they said, is providing risk-benefit education and counseling to patients, and reviewing fertility preservation considerations and options. Then, either estradiol or testosterone is initiated; Further suppression of endogenous hormones also might be indicated in feminization therapy in particular. The authors provided several continuing education resources for clinicians and other health care team members, and noted that a “train the trainer” model can prove effective, with a core team training others once they’ve become comfortable with the ins and outs of hormone prescribing and monitoring.
Having a staff that looks like the patient panel can go a long way toward promoting authentic inclusivity, but Dr. Morenz and her colleagues cautioned against hiring practices that amount to tokenism, or expecting transgender or gender-diverse staff to be ambassadors or spokespeople for others.
Taken together, the start-up costs for providing transgender care can be “minimal,” wrote the blueprint authors, because many free and low-cost educational resources are available. Some of the only real outlays may come from altering restroom signage and tweaking the electronic health record to accommodate gender diversity.
A practice that goes forward with transgender care, they conclude, “will provide a unique opportunity to holistically improve wellness and quality of life for transgender and gender-diverse people,” joining the “growing and passionate network of clinical practice teams who are committed to health care, innovation, and equity for transgender and gender-diverse communities.”
Dr. Morenz reported no outside sources of funding and reported that she has no relevant conflicts of interest.
SOURCE: Morenz AM et al. Ann Fam Med. 2020 Jan;18(1):73-9.
In a new “blueprint” for practices planning to implement a transgender care program, Anna M. Morenz, MD, and her coauthors emphasized that more than technical skills are needed to build an effective and welcoming transgender health practice.
All patient-facing staff – from schedulers and receptionists to nurses and billers – should “receive a foundational level of training in cultural sensitivity and effective communication with transgender and gender-diverse persons,” they wrote. In addition, they emphasized, “the workplace culture must ensure that chatter behind closed doors does not differ from patient-facing language.”
One thing that’s become clear over time, noted the authors of the blueprint, is that transgender care is no longer limited to the endocrinologist’s office. “After years of referring transgender and gender-diverse patients to specialty clinics and endocrinologists, transgender health experts have come to agree that gender-affirming hormone therapy can be safely delivered as part of routine care by a trained primary care clinician,” wrote Dr. Morenz, an internal medicine resident at the University of Washington, Seattle, and her coauthors.
Nor do most adults receiving gender-affirming care require mental health services, unless the patient or the primary care clinician sees a need or utility for psychological care. The blueprint was published in the Annals of Family Medicine.
The first step to setting up transgender services within a primary care practice is to conduct a needs assessment, suggested Dr. Morenz and her colleagues. Whether in-person focus groups or online surveys or questionnaires are best might depend on the community climate, they wrote. When stigma is high, the opportunity for anonymity might provide more robust results. Other considerations include whether there’s a concentration of transgender people with particularly high need or risk in the community – for example, transgender women of color, who might be at higher risk of HIV/AIDS than the general population. Depending on the needs of a particular community, initial transgender care efforts may have a focus on such a population.
A practice also should conduct a realistic appraisal of its own strengths and areas of weakness: Is signage inclusive? Do intake forms afford flexibility in gender and pronoun preference? Are front office staff comfortable greeting members of the lesbian-gay-bisexual-transgender-queer-intersex-asexual (LGBTQIA) community? What about restroom signage – is there a gender-inclusive option?
Competent provision of trauma-informed care goes hand in hand with assessment and preparation for providing transgender care, noted the blueprint authors, because “transgender and gender-diverse people experience high levels of trauma and stress related to minority status.”
Performing outreach within an organization and community also can unearth existing services, so that a primary care transgender practice dovetails with and complements those ongoing efforts, avoiding unnecessarily duplicative services. “All transgender health programs can benefit from developing broad relationships with external agencies, community-based organizatons, and individual practitioners who provide a range of services and can function as a network for knowledge-sharing and referrals,” noted Dr. Morenz and her coauthors.
“Starting a new program, especially one focused on a stigmatized population, can generate staff concerns and resistance,” acknowledged Dr. Morenz and her colleagues. Efforts at getting organizational buy-in can emphasize that providing transgender care helps meet ethical obligations within medicine. Emphasizing that making such care available is really at the vanguard of best practices might help overcome some resistance, they said.
, with at least one champion having a leadership role within the organization, wrote Dr. Morenz and her colleagues.
A variety of care models can work when a practice is initiating transgender care, depending on community needs, internal resources, and the commitment level of various stakeholders. An evening clinic staffed by a small number of clinicians can be a good way to test the waters in some cases. Other facilities might wish to identify clinicians who are competent to offer hormone therapy, while still other clinics might be able to incorporate transgender care more globally within their practice. Regardless of which service model a practice opts for, however, it’s crucial to have staff members who are savvy navigators of insurance reimbursement for gender-affirming care.
And when transgender care is nested within a practice, those patients must not feel like second-class citizens of the clinic, or that they’re receiving care that’s somehow different or substandard. For example, wrote Dr. Morenz and her coauthors, a facility must consider what will happen when a transgender patient presents for urgent health needs and the primary care clinician is not available.
The nuts and bolts of providing safe and effective gender-affirming hormone therapy, said the blueprint authors, can be mastered with training and practice. “Despite common concerns that transgender health care is complicated, it is in fact as straightforward as managing common chronic diseases.”
The first step, they said, is providing risk-benefit education and counseling to patients, and reviewing fertility preservation considerations and options. Then, either estradiol or testosterone is initiated; Further suppression of endogenous hormones also might be indicated in feminization therapy in particular. The authors provided several continuing education resources for clinicians and other health care team members, and noted that a “train the trainer” model can prove effective, with a core team training others once they’ve become comfortable with the ins and outs of hormone prescribing and monitoring.
Having a staff that looks like the patient panel can go a long way toward promoting authentic inclusivity, but Dr. Morenz and her colleagues cautioned against hiring practices that amount to tokenism, or expecting transgender or gender-diverse staff to be ambassadors or spokespeople for others.
Taken together, the start-up costs for providing transgender care can be “minimal,” wrote the blueprint authors, because many free and low-cost educational resources are available. Some of the only real outlays may come from altering restroom signage and tweaking the electronic health record to accommodate gender diversity.
A practice that goes forward with transgender care, they conclude, “will provide a unique opportunity to holistically improve wellness and quality of life for transgender and gender-diverse people,” joining the “growing and passionate network of clinical practice teams who are committed to health care, innovation, and equity for transgender and gender-diverse communities.”
Dr. Morenz reported no outside sources of funding and reported that she has no relevant conflicts of interest.
SOURCE: Morenz AM et al. Ann Fam Med. 2020 Jan;18(1):73-9.
FROM THE ANNALS OF FAMILY MEDICINE
Cardiovascular disease risk higher in patients with schizophrenia, metabolic syndrome
Metabolic syndrome is common among patients with schizophrenia, and those with metabolic syndrome are at significantly higher risk for cardiovascular disease, according to Shadi Naderyan Fe’li of the department of biostatistics and epidemiology at Shahid Sadoughi University of Medical Sciences in Yazd, Iran, and associates.
The cross-sectional study, performed on 100 patients with schizophrenia (83 men, 17 women), was published in the Medical Journal of the Islamic Republic of Iran. (men, 21.7%; women, 52.9%); the most common component of metabolic disorder was low HDL cholesterol in males and abdominal adiposity in females.
Based on Framingham Risk Scores, 76% of study participants had a low risk of cardiovascular disease, 16% had intermediate risk, and 8% had high risk. However, patients were almost twice as likely to have intermediate or high risk of cardiovascular disease if they also had metabolic syndrome (P = .042).
“Considering the findings of this study as well as other recent reports, psychiatrists and health care staff should be informed about the potential metabolic side effects of antipsychotics and unhealthy lifestyles among these patients. Furthermore, regular monitoring of metabolic risk factors is suggested. In addition, medical and behavioral interventions should be conducted for patients with [metabolic syndrome],” the investigators concluded.
The investigators reported that they had no conflicts of interest.
lfranki@mdedge.com
SOURCE: Fe’li SN et al. Med J Islam Repub Iran. 2019 Sep 16. doi: 10.34171/mjiri.33.97.
Metabolic syndrome is common among patients with schizophrenia, and those with metabolic syndrome are at significantly higher risk for cardiovascular disease, according to Shadi Naderyan Fe’li of the department of biostatistics and epidemiology at Shahid Sadoughi University of Medical Sciences in Yazd, Iran, and associates.
The cross-sectional study, performed on 100 patients with schizophrenia (83 men, 17 women), was published in the Medical Journal of the Islamic Republic of Iran. (men, 21.7%; women, 52.9%); the most common component of metabolic disorder was low HDL cholesterol in males and abdominal adiposity in females.
Based on Framingham Risk Scores, 76% of study participants had a low risk of cardiovascular disease, 16% had intermediate risk, and 8% had high risk. However, patients were almost twice as likely to have intermediate or high risk of cardiovascular disease if they also had metabolic syndrome (P = .042).
“Considering the findings of this study as well as other recent reports, psychiatrists and health care staff should be informed about the potential metabolic side effects of antipsychotics and unhealthy lifestyles among these patients. Furthermore, regular monitoring of metabolic risk factors is suggested. In addition, medical and behavioral interventions should be conducted for patients with [metabolic syndrome],” the investigators concluded.
The investigators reported that they had no conflicts of interest.
lfranki@mdedge.com
SOURCE: Fe’li SN et al. Med J Islam Repub Iran. 2019 Sep 16. doi: 10.34171/mjiri.33.97.
Metabolic syndrome is common among patients with schizophrenia, and those with metabolic syndrome are at significantly higher risk for cardiovascular disease, according to Shadi Naderyan Fe’li of the department of biostatistics and epidemiology at Shahid Sadoughi University of Medical Sciences in Yazd, Iran, and associates.
The cross-sectional study, performed on 100 patients with schizophrenia (83 men, 17 women), was published in the Medical Journal of the Islamic Republic of Iran. (men, 21.7%; women, 52.9%); the most common component of metabolic disorder was low HDL cholesterol in males and abdominal adiposity in females.
Based on Framingham Risk Scores, 76% of study participants had a low risk of cardiovascular disease, 16% had intermediate risk, and 8% had high risk. However, patients were almost twice as likely to have intermediate or high risk of cardiovascular disease if they also had metabolic syndrome (P = .042).
“Considering the findings of this study as well as other recent reports, psychiatrists and health care staff should be informed about the potential metabolic side effects of antipsychotics and unhealthy lifestyles among these patients. Furthermore, regular monitoring of metabolic risk factors is suggested. In addition, medical and behavioral interventions should be conducted for patients with [metabolic syndrome],” the investigators concluded.
The investigators reported that they had no conflicts of interest.
lfranki@mdedge.com
SOURCE: Fe’li SN et al. Med J Islam Repub Iran. 2019 Sep 16. doi: 10.34171/mjiri.33.97.
FROM THE MEDICAL JOURNAL OF THE ISLAMIC REPUBLIC OF IRAN
Colorectal cancer risk elevated in anticoagulated AF patients with lower GI bleeding
A new study has found that patients with atrial fibrillation (AF) who take oral anticoagulants and then suffer from lower GI bleeding have a much higher risk of being diagnosed with colorectal cancer.
“Our data indicate that lower GI bleeding in these patients should not be dismissed as a mere consequence of anticoagulation treatment,” wrote Peter Vibe Rasmussen, MD, of the University of Copenhagen in Denmark and his coauthors, adding that “timely examination could potentially provide early detection of malignant colorectal lesions.” The study was published in the European Heart Journal.
To determine whether being treated with oral anticoagulants (OACs) and subsequently undergoing GI bleeding indicates colorectal cancer, the researchers examined data from 125,418 Danish AF patients gathered from a nationwide registry. Their median age was 73 years old, and 58% (n = 73,271) were males.
Over a 3-year follow-up period, 2,576 cases of lower GI bleeding were identified; 140 of those cases led to a diagnosis of colorectal cancer within a year. (95% confidence interval, 6.1-10.6%) in patients aged 76-80 and 3.7% (95% CI, 2.2-6.2%) in patients 65 years old or younger.
All age groups had a higher risk of colorectal cancer after bleeding, compared with patients without bleeding. Patients 65 or younger had a risk ratio of 24.2 (95% CI, 14.5-40.4) while patients over 85 had a risk ratio of 12.3 (95% CI, 7.9-19.0).
The authors acknowledged their study’s limitations, including a lack of information regarding certain risk factors, such as alcohol consumption, dietary habits, and obesity. In addition, they noted that the absolute risk of colorectal cancer in patients without bleeding is likely underdiagnosed, as “patients without GI bleeding are less likely to undergo diagnostic procedures.”
Two of the authors are employees at Bristol-Myers Squibb and Pfizer, respectively. Six additional authors reported receiving grants, speaker honoraria and consulting fees from various pharmaceutical companies. The remaining authors reported no conflicts of interest.
SOURCE: Rasmussen PV et al. Eur Heart J. 2020 Feb 7. doi: 10.1093/eurheartj/ehz964.
A new study has found that patients with atrial fibrillation (AF) who take oral anticoagulants and then suffer from lower GI bleeding have a much higher risk of being diagnosed with colorectal cancer.
“Our data indicate that lower GI bleeding in these patients should not be dismissed as a mere consequence of anticoagulation treatment,” wrote Peter Vibe Rasmussen, MD, of the University of Copenhagen in Denmark and his coauthors, adding that “timely examination could potentially provide early detection of malignant colorectal lesions.” The study was published in the European Heart Journal.
To determine whether being treated with oral anticoagulants (OACs) and subsequently undergoing GI bleeding indicates colorectal cancer, the researchers examined data from 125,418 Danish AF patients gathered from a nationwide registry. Their median age was 73 years old, and 58% (n = 73,271) were males.
Over a 3-year follow-up period, 2,576 cases of lower GI bleeding were identified; 140 of those cases led to a diagnosis of colorectal cancer within a year. (95% confidence interval, 6.1-10.6%) in patients aged 76-80 and 3.7% (95% CI, 2.2-6.2%) in patients 65 years old or younger.
All age groups had a higher risk of colorectal cancer after bleeding, compared with patients without bleeding. Patients 65 or younger had a risk ratio of 24.2 (95% CI, 14.5-40.4) while patients over 85 had a risk ratio of 12.3 (95% CI, 7.9-19.0).
The authors acknowledged their study’s limitations, including a lack of information regarding certain risk factors, such as alcohol consumption, dietary habits, and obesity. In addition, they noted that the absolute risk of colorectal cancer in patients without bleeding is likely underdiagnosed, as “patients without GI bleeding are less likely to undergo diagnostic procedures.”
Two of the authors are employees at Bristol-Myers Squibb and Pfizer, respectively. Six additional authors reported receiving grants, speaker honoraria and consulting fees from various pharmaceutical companies. The remaining authors reported no conflicts of interest.
SOURCE: Rasmussen PV et al. Eur Heart J. 2020 Feb 7. doi: 10.1093/eurheartj/ehz964.
A new study has found that patients with atrial fibrillation (AF) who take oral anticoagulants and then suffer from lower GI bleeding have a much higher risk of being diagnosed with colorectal cancer.
“Our data indicate that lower GI bleeding in these patients should not be dismissed as a mere consequence of anticoagulation treatment,” wrote Peter Vibe Rasmussen, MD, of the University of Copenhagen in Denmark and his coauthors, adding that “timely examination could potentially provide early detection of malignant colorectal lesions.” The study was published in the European Heart Journal.
To determine whether being treated with oral anticoagulants (OACs) and subsequently undergoing GI bleeding indicates colorectal cancer, the researchers examined data from 125,418 Danish AF patients gathered from a nationwide registry. Their median age was 73 years old, and 58% (n = 73,271) were males.
Over a 3-year follow-up period, 2,576 cases of lower GI bleeding were identified; 140 of those cases led to a diagnosis of colorectal cancer within a year. (95% confidence interval, 6.1-10.6%) in patients aged 76-80 and 3.7% (95% CI, 2.2-6.2%) in patients 65 years old or younger.
All age groups had a higher risk of colorectal cancer after bleeding, compared with patients without bleeding. Patients 65 or younger had a risk ratio of 24.2 (95% CI, 14.5-40.4) while patients over 85 had a risk ratio of 12.3 (95% CI, 7.9-19.0).
The authors acknowledged their study’s limitations, including a lack of information regarding certain risk factors, such as alcohol consumption, dietary habits, and obesity. In addition, they noted that the absolute risk of colorectal cancer in patients without bleeding is likely underdiagnosed, as “patients without GI bleeding are less likely to undergo diagnostic procedures.”
Two of the authors are employees at Bristol-Myers Squibb and Pfizer, respectively. Six additional authors reported receiving grants, speaker honoraria and consulting fees from various pharmaceutical companies. The remaining authors reported no conflicts of interest.
SOURCE: Rasmussen PV et al. Eur Heart J. 2020 Feb 7. doi: 10.1093/eurheartj/ehz964.
FROM the European Heart Journal