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Consider drug treatment in late-life women with osteoporosis
and therefore have more to gain from osteoporosis treatment, regardless of the presence of any comorbidities, according to a new study.
To determine how and when to treat older women for osteoporosis, Kristine E. Ensrud, MD, of the University of Minnesota, Minneapolis, and coauthors studied active surviving participants in the Study of Osteoporotic Fractures. The cohort comprised 1,528 women who met criteria for either osteoporosis (n = 761) or without osteoporosis but at high fracture risk (n = 767). Mean age at the time of examination was 84 years and mean femoral neck bone mineral density (BMD) T-score was −2.24.
During an average follow-up period of 4.4 years after initial examination, 125 women (9%) experienced a hip fracture and 287 (19%) died without experiencing that outcome. The 5-year absolute probability of mortality was 25% (95% confidence interval, 21.8%-28.1%) in women with osteoporosis and 19% (95% CI, 16.6%-22.3%) in women without osteoporosis but at high fracture risk. Although both groups saw mortality probability increase with more comorbidities and poorer prognosis, 5-year hip fracture probability was 13% (95% CI, 10.7%-15.5%) among women with osteoporosis and 4% (95% CI, 2.8%-5.6%) among women without osteoporosis but at high fracture risk.
This probability of the women with osteoporosis experiencing a hip fracture, “even after considering their competing mortality risk” suggests that “initiation of drug treatment in late-life women with osteoporosis may still be effective in the prevention of subsequent hip fracture,” the researchers wrote in JAMA Internal Medicine.
Dr. Ensrud and associates acknowledged their study’s limitations, including the cohort being made up of community-dwelling white women and thus the results not being generalizable to men or women of other racial or ethnic groups. But the researchers noted that the mean femoral neck BMD of women in the study “was essentially identical to that of a nationally representative sample of community-dwelling women 80 years and older enrolled in the 2005 to 2008 NHANES [National Health and Nutrition Examination Survey].”
Dr. Cynthia M. Boyd reported receiving royalties from UpToDate and a grant from the National Institutes of Aging Dr. Katie L. Stone reported receiving grant support from Merck, and Dr. Lisa Langsetmo reported receiving grants from the National Institutes of Health and Merck. No other authors reported any relevant financial disclosures. The Study of Osteoporotic Fractures was supported by NIH and grants from NIA.
SOURCE: Ensrud KE et al. JAMA Intern Med. 2019 Jun 17. doi: 10.1001/jamainternmed.2019.0682.
Older patients with osteoporosis with multimorbidities are the most at risk for hip fractures, which should place an emphasis on research into their treatment, Sarah D. Berry, MD, MPH; Sandra Shi, MD; and Douglas P. Kiel, MD, MPH, of Harvard Medical School, Boston, wrote in an invited commentary.
The coauthors noted that the study by Ensrud et al. is of “great clinical importance, given the ongoing recognition that clinical guidelines should consider multimorbidity.” Currently, the guidelines for treating osteoporosis do not consider age, comorbidities, or frailty, but this study indicates that older women can see benefits from treatment.
They also acknowledged the value of patient preference, referencing a study where 80% of older women “would prefer death as opposed to a hip fracture leading to institutionalization.” All in all, the work of Ensrud et al. is a reminder of “the dangers in ignoring the problem” and the need for future guidelines in osteoporosis treatment to address osteoporosis treatment for older patients with multimorbidity.
These comments are adapted from an invited commentary accompanying the article by Ensrud et al. (JAMA Intern Med. 2019 Jun 17. doi: 10.1001/jamainternmed.2019.0688 ). Dr. Berry reported receiving royalties from UpToDate outside the submitted work. Dr. Kiel reported receiving royalties from UpToDate, along with grants from the Dairy Council and Radius Health, and personal fees from Springer outside the submitted work. Dr. Shi reported no relevant financial disclosures. No funding for this editorial was reported.
Older patients with osteoporosis with multimorbidities are the most at risk for hip fractures, which should place an emphasis on research into their treatment, Sarah D. Berry, MD, MPH; Sandra Shi, MD; and Douglas P. Kiel, MD, MPH, of Harvard Medical School, Boston, wrote in an invited commentary.
The coauthors noted that the study by Ensrud et al. is of “great clinical importance, given the ongoing recognition that clinical guidelines should consider multimorbidity.” Currently, the guidelines for treating osteoporosis do not consider age, comorbidities, or frailty, but this study indicates that older women can see benefits from treatment.
They also acknowledged the value of patient preference, referencing a study where 80% of older women “would prefer death as opposed to a hip fracture leading to institutionalization.” All in all, the work of Ensrud et al. is a reminder of “the dangers in ignoring the problem” and the need for future guidelines in osteoporosis treatment to address osteoporosis treatment for older patients with multimorbidity.
These comments are adapted from an invited commentary accompanying the article by Ensrud et al. (JAMA Intern Med. 2019 Jun 17. doi: 10.1001/jamainternmed.2019.0688 ). Dr. Berry reported receiving royalties from UpToDate outside the submitted work. Dr. Kiel reported receiving royalties from UpToDate, along with grants from the Dairy Council and Radius Health, and personal fees from Springer outside the submitted work. Dr. Shi reported no relevant financial disclosures. No funding for this editorial was reported.
Older patients with osteoporosis with multimorbidities are the most at risk for hip fractures, which should place an emphasis on research into their treatment, Sarah D. Berry, MD, MPH; Sandra Shi, MD; and Douglas P. Kiel, MD, MPH, of Harvard Medical School, Boston, wrote in an invited commentary.
The coauthors noted that the study by Ensrud et al. is of “great clinical importance, given the ongoing recognition that clinical guidelines should consider multimorbidity.” Currently, the guidelines for treating osteoporosis do not consider age, comorbidities, or frailty, but this study indicates that older women can see benefits from treatment.
They also acknowledged the value of patient preference, referencing a study where 80% of older women “would prefer death as opposed to a hip fracture leading to institutionalization.” All in all, the work of Ensrud et al. is a reminder of “the dangers in ignoring the problem” and the need for future guidelines in osteoporosis treatment to address osteoporosis treatment for older patients with multimorbidity.
These comments are adapted from an invited commentary accompanying the article by Ensrud et al. (JAMA Intern Med. 2019 Jun 17. doi: 10.1001/jamainternmed.2019.0688 ). Dr. Berry reported receiving royalties from UpToDate outside the submitted work. Dr. Kiel reported receiving royalties from UpToDate, along with grants from the Dairy Council and Radius Health, and personal fees from Springer outside the submitted work. Dr. Shi reported no relevant financial disclosures. No funding for this editorial was reported.
and therefore have more to gain from osteoporosis treatment, regardless of the presence of any comorbidities, according to a new study.
To determine how and when to treat older women for osteoporosis, Kristine E. Ensrud, MD, of the University of Minnesota, Minneapolis, and coauthors studied active surviving participants in the Study of Osteoporotic Fractures. The cohort comprised 1,528 women who met criteria for either osteoporosis (n = 761) or without osteoporosis but at high fracture risk (n = 767). Mean age at the time of examination was 84 years and mean femoral neck bone mineral density (BMD) T-score was −2.24.
During an average follow-up period of 4.4 years after initial examination, 125 women (9%) experienced a hip fracture and 287 (19%) died without experiencing that outcome. The 5-year absolute probability of mortality was 25% (95% confidence interval, 21.8%-28.1%) in women with osteoporosis and 19% (95% CI, 16.6%-22.3%) in women without osteoporosis but at high fracture risk. Although both groups saw mortality probability increase with more comorbidities and poorer prognosis, 5-year hip fracture probability was 13% (95% CI, 10.7%-15.5%) among women with osteoporosis and 4% (95% CI, 2.8%-5.6%) among women without osteoporosis but at high fracture risk.
This probability of the women with osteoporosis experiencing a hip fracture, “even after considering their competing mortality risk” suggests that “initiation of drug treatment in late-life women with osteoporosis may still be effective in the prevention of subsequent hip fracture,” the researchers wrote in JAMA Internal Medicine.
Dr. Ensrud and associates acknowledged their study’s limitations, including the cohort being made up of community-dwelling white women and thus the results not being generalizable to men or women of other racial or ethnic groups. But the researchers noted that the mean femoral neck BMD of women in the study “was essentially identical to that of a nationally representative sample of community-dwelling women 80 years and older enrolled in the 2005 to 2008 NHANES [National Health and Nutrition Examination Survey].”
Dr. Cynthia M. Boyd reported receiving royalties from UpToDate and a grant from the National Institutes of Aging Dr. Katie L. Stone reported receiving grant support from Merck, and Dr. Lisa Langsetmo reported receiving grants from the National Institutes of Health and Merck. No other authors reported any relevant financial disclosures. The Study of Osteoporotic Fractures was supported by NIH and grants from NIA.
SOURCE: Ensrud KE et al. JAMA Intern Med. 2019 Jun 17. doi: 10.1001/jamainternmed.2019.0682.
and therefore have more to gain from osteoporosis treatment, regardless of the presence of any comorbidities, according to a new study.
To determine how and when to treat older women for osteoporosis, Kristine E. Ensrud, MD, of the University of Minnesota, Minneapolis, and coauthors studied active surviving participants in the Study of Osteoporotic Fractures. The cohort comprised 1,528 women who met criteria for either osteoporosis (n = 761) or without osteoporosis but at high fracture risk (n = 767). Mean age at the time of examination was 84 years and mean femoral neck bone mineral density (BMD) T-score was −2.24.
During an average follow-up period of 4.4 years after initial examination, 125 women (9%) experienced a hip fracture and 287 (19%) died without experiencing that outcome. The 5-year absolute probability of mortality was 25% (95% confidence interval, 21.8%-28.1%) in women with osteoporosis and 19% (95% CI, 16.6%-22.3%) in women without osteoporosis but at high fracture risk. Although both groups saw mortality probability increase with more comorbidities and poorer prognosis, 5-year hip fracture probability was 13% (95% CI, 10.7%-15.5%) among women with osteoporosis and 4% (95% CI, 2.8%-5.6%) among women without osteoporosis but at high fracture risk.
This probability of the women with osteoporosis experiencing a hip fracture, “even after considering their competing mortality risk” suggests that “initiation of drug treatment in late-life women with osteoporosis may still be effective in the prevention of subsequent hip fracture,” the researchers wrote in JAMA Internal Medicine.
Dr. Ensrud and associates acknowledged their study’s limitations, including the cohort being made up of community-dwelling white women and thus the results not being generalizable to men or women of other racial or ethnic groups. But the researchers noted that the mean femoral neck BMD of women in the study “was essentially identical to that of a nationally representative sample of community-dwelling women 80 years and older enrolled in the 2005 to 2008 NHANES [National Health and Nutrition Examination Survey].”
Dr. Cynthia M. Boyd reported receiving royalties from UpToDate and a grant from the National Institutes of Aging Dr. Katie L. Stone reported receiving grant support from Merck, and Dr. Lisa Langsetmo reported receiving grants from the National Institutes of Health and Merck. No other authors reported any relevant financial disclosures. The Study of Osteoporotic Fractures was supported by NIH and grants from NIA.
SOURCE: Ensrud KE et al. JAMA Intern Med. 2019 Jun 17. doi: 10.1001/jamainternmed.2019.0682.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Medical treatment to prevent osteoporotic hip fracture in women over age 80 likely is worthwhile.
Major finding: Five-year hip fracture probability was 13% among women with osteoporosis and 4% among women without osteoporosis but at high fracture risk.
Study details: A prospective cohort study of 1,528 women 80 years and older who were potential candidates for osteoporosis drug treatment.
Disclosures: Dr. Cynthia M. Boyd reported receiving royalties from UpToDate and a grant from the National Institutes of Aging Dr. Katie L. Stone reported receiving grant support from Merck, and Dr. Lisa Langsetmo reported receiving grants from the National Institutes of Health and Merck. No other authors reported any relevant financial disclosures. The Study of Osteoporotic Fractures was supported by NIH and grants from NIA.
Source: Ensrud KE et al. JAMA Intern Med. 2019 Jun 17. doi: 10.1001/jamainternmed.2019.0682.
Many cardiac catheterization, electrophysiology lab directors receive big industry payments
according to a new study of payments to lab directors at top hospitals.
“With continued concerns about rising health care costs, it is important to ensure that physician decisions regarding choice of devices and other pharmaceutical therapies be driven by clinical and cost effectiveness, not industry influence,” Amarnath Annapureddy, MD, of the Yale School of Medicine, New Haven, Conn. and coauthors wrote in their study published in JAMA Internal Medicine.
Dr. Annapureddy and fellow researchers analyzed Open Payments Program data from 2017 to determine payments made to cardiac catheterization and electrophysiology laboratory directors the top 100 hospitals based on US News and World Report’s ranking. They compared those payments to payments made to local interventional cardiologists and electrophysiologists, along with payments to interventional cardiologists and electrophysiologists from across the country.
In 2017, the directors of the top cardiac catheterization and electrophysiology labs received $1,416,232 and $2,307,504 from industry, respectively. The median payments to cardiac catheterization lab directors were significantly higher ($3,203 [$388-$14,156]), compared with interventional cardiologists ($1,064 [$206-$4,104]). The results were similar comparing electrophysiology lab directors with electrophysiology physicians practicing in the same zip codes ($10,521 [$1,159-$35,076] versus $2,900 [$549-$13,101]).
Overall, nearly one-third of cardiac catheterization lab directors and nearly half of electrophysiology lab directors received payments of $10,000 or more, an amount the National Academy of Medicine noted as constituting “a significant conflict of interest.”
The coauthors acknowledged their study’s limitations, including the possibility that they misclassified some lab directors and the fact that Open Payments Program’s data may have been inaccurate. However, they also anticipated that “inaccuracies would not vary between laboratory directors and other clinicians.”
Dr. Nihar R. Desai reported receiving funding from the Centers for Medicare & Medicaid Services, financial support from Johnson & Johnson, and research support from the American College of Cardiology Foundation. Dr. Jeptha P. Curtis reported receiving salary support from the American College of Cardiology, funding from the Centers for Medicare & Medicaid Services, and equity interest in Medtronic. No other authors reported any relevant financial disclosures. No funding for the study was reported.
SOURCE: Annapureddy A et al. JAMA Intern Med. 2019 Jun 17. doi:10.1001/jamainternmed.2018.8775.
Far too much about the purchasing of medical devices – and the costs passed to insurers and ultimately patients – is secretive and requires an overhaul, according to Rita F. Redberg, MD.
Noting that the results from the study by Annapureddy et al. found that nearly one-third of catheterization lab directors and one-half of electrophysiology lab directors receive more than $10,000 annually, she wrote that “the prevalence of financial relationships and the magnitude of the payments are of great concern.” Even picking up a meal can be influential, she added; imagine the impact of such a large payment.
What can be done? “Professional society guidelines should prohibit doctors with relationships with industry from participating in decisions about what devices their hospital chooses to purchase,” she stated, and patients should be made aware of relationships between doctors and device companies. More transparency, across the board, is necessary.
Dr. Redburg is a cardiologist at the University of California, San Francisco; she is interested in promoting high-value health care, which emphasizes delivering appropriate treatment while avoiding tests or therapies without known benefit. These comments are adapted from an editorial accompanying the article by Annapureddy et al. (JAMA Intern Med. 2019 Jun 17. doi:10.1001/jamainternmed.2018.8737). Dr. Redberg reported no conflicts of interest.
Far too much about the purchasing of medical devices – and the costs passed to insurers and ultimately patients – is secretive and requires an overhaul, according to Rita F. Redberg, MD.
Noting that the results from the study by Annapureddy et al. found that nearly one-third of catheterization lab directors and one-half of electrophysiology lab directors receive more than $10,000 annually, she wrote that “the prevalence of financial relationships and the magnitude of the payments are of great concern.” Even picking up a meal can be influential, she added; imagine the impact of such a large payment.
What can be done? “Professional society guidelines should prohibit doctors with relationships with industry from participating in decisions about what devices their hospital chooses to purchase,” she stated, and patients should be made aware of relationships between doctors and device companies. More transparency, across the board, is necessary.
Dr. Redburg is a cardiologist at the University of California, San Francisco; she is interested in promoting high-value health care, which emphasizes delivering appropriate treatment while avoiding tests or therapies without known benefit. These comments are adapted from an editorial accompanying the article by Annapureddy et al. (JAMA Intern Med. 2019 Jun 17. doi:10.1001/jamainternmed.2018.8737). Dr. Redberg reported no conflicts of interest.
Far too much about the purchasing of medical devices – and the costs passed to insurers and ultimately patients – is secretive and requires an overhaul, according to Rita F. Redberg, MD.
Noting that the results from the study by Annapureddy et al. found that nearly one-third of catheterization lab directors and one-half of electrophysiology lab directors receive more than $10,000 annually, she wrote that “the prevalence of financial relationships and the magnitude of the payments are of great concern.” Even picking up a meal can be influential, she added; imagine the impact of such a large payment.
What can be done? “Professional society guidelines should prohibit doctors with relationships with industry from participating in decisions about what devices their hospital chooses to purchase,” she stated, and patients should be made aware of relationships between doctors and device companies. More transparency, across the board, is necessary.
Dr. Redburg is a cardiologist at the University of California, San Francisco; she is interested in promoting high-value health care, which emphasizes delivering appropriate treatment while avoiding tests or therapies without known benefit. These comments are adapted from an editorial accompanying the article by Annapureddy et al. (JAMA Intern Med. 2019 Jun 17. doi:10.1001/jamainternmed.2018.8737). Dr. Redberg reported no conflicts of interest.
according to a new study of payments to lab directors at top hospitals.
“With continued concerns about rising health care costs, it is important to ensure that physician decisions regarding choice of devices and other pharmaceutical therapies be driven by clinical and cost effectiveness, not industry influence,” Amarnath Annapureddy, MD, of the Yale School of Medicine, New Haven, Conn. and coauthors wrote in their study published in JAMA Internal Medicine.
Dr. Annapureddy and fellow researchers analyzed Open Payments Program data from 2017 to determine payments made to cardiac catheterization and electrophysiology laboratory directors the top 100 hospitals based on US News and World Report’s ranking. They compared those payments to payments made to local interventional cardiologists and electrophysiologists, along with payments to interventional cardiologists and electrophysiologists from across the country.
In 2017, the directors of the top cardiac catheterization and electrophysiology labs received $1,416,232 and $2,307,504 from industry, respectively. The median payments to cardiac catheterization lab directors were significantly higher ($3,203 [$388-$14,156]), compared with interventional cardiologists ($1,064 [$206-$4,104]). The results were similar comparing electrophysiology lab directors with electrophysiology physicians practicing in the same zip codes ($10,521 [$1,159-$35,076] versus $2,900 [$549-$13,101]).
Overall, nearly one-third of cardiac catheterization lab directors and nearly half of electrophysiology lab directors received payments of $10,000 or more, an amount the National Academy of Medicine noted as constituting “a significant conflict of interest.”
The coauthors acknowledged their study’s limitations, including the possibility that they misclassified some lab directors and the fact that Open Payments Program’s data may have been inaccurate. However, they also anticipated that “inaccuracies would not vary between laboratory directors and other clinicians.”
Dr. Nihar R. Desai reported receiving funding from the Centers for Medicare & Medicaid Services, financial support from Johnson & Johnson, and research support from the American College of Cardiology Foundation. Dr. Jeptha P. Curtis reported receiving salary support from the American College of Cardiology, funding from the Centers for Medicare & Medicaid Services, and equity interest in Medtronic. No other authors reported any relevant financial disclosures. No funding for the study was reported.
SOURCE: Annapureddy A et al. JAMA Intern Med. 2019 Jun 17. doi:10.1001/jamainternmed.2018.8775.
according to a new study of payments to lab directors at top hospitals.
“With continued concerns about rising health care costs, it is important to ensure that physician decisions regarding choice of devices and other pharmaceutical therapies be driven by clinical and cost effectiveness, not industry influence,” Amarnath Annapureddy, MD, of the Yale School of Medicine, New Haven, Conn. and coauthors wrote in their study published in JAMA Internal Medicine.
Dr. Annapureddy and fellow researchers analyzed Open Payments Program data from 2017 to determine payments made to cardiac catheterization and electrophysiology laboratory directors the top 100 hospitals based on US News and World Report’s ranking. They compared those payments to payments made to local interventional cardiologists and electrophysiologists, along with payments to interventional cardiologists and electrophysiologists from across the country.
In 2017, the directors of the top cardiac catheterization and electrophysiology labs received $1,416,232 and $2,307,504 from industry, respectively. The median payments to cardiac catheterization lab directors were significantly higher ($3,203 [$388-$14,156]), compared with interventional cardiologists ($1,064 [$206-$4,104]). The results were similar comparing electrophysiology lab directors with electrophysiology physicians practicing in the same zip codes ($10,521 [$1,159-$35,076] versus $2,900 [$549-$13,101]).
Overall, nearly one-third of cardiac catheterization lab directors and nearly half of electrophysiology lab directors received payments of $10,000 or more, an amount the National Academy of Medicine noted as constituting “a significant conflict of interest.”
The coauthors acknowledged their study’s limitations, including the possibility that they misclassified some lab directors and the fact that Open Payments Program’s data may have been inaccurate. However, they also anticipated that “inaccuracies would not vary between laboratory directors and other clinicians.”
Dr. Nihar R. Desai reported receiving funding from the Centers for Medicare & Medicaid Services, financial support from Johnson & Johnson, and research support from the American College of Cardiology Foundation. Dr. Jeptha P. Curtis reported receiving salary support from the American College of Cardiology, funding from the Centers for Medicare & Medicaid Services, and equity interest in Medtronic. No other authors reported any relevant financial disclosures. No funding for the study was reported.
SOURCE: Annapureddy A et al. JAMA Intern Med. 2019 Jun 17. doi:10.1001/jamainternmed.2018.8775.
FROM JAMA INTERNAL MEDICINE
USPSTF recommends PrEP combo for adults at high risk of HIV infection
Pre-exposure prophylaxis (PrEP) plus effective antiretroviral therapy should be offered to people at high risk of HIV acquisition, according to a new recommendation from the U.S. Preventive Services Task Force (USPSTF).
“The USPSTF concludes with high certainty that the net benefit of the use of PrEP to reduce the risk of acquisition of HIV infection in persons at high risk of HIV infection is substantial,” wrote first author Douglas K. Owens, MD, of Stanford (Calif.) University and fellow members of the USPSTF. The recommendation was published in JAMA.
In various at-risk groups – including men who have sex with men, people at risk through heterosexual contact, and people who inject drugs – the USPSTF recommends a Food and Drug Adminstration–approved, once-daily oral treatment with combined tenofovir disoproxil fumarate and emtricitabine.
This recommendation was developed after a systematic review of PrEP’s effects on HIV, adherence to the treatment, and accuracy in identifying potential treatment candidates. “The findings of this review are generally consistent with those from other recent meta-analyses that found PrEP to be effective at reducing risk of HIV infection and found greater effectiveness in trials reporting higher adherence,” wrote Roger Chou, MD, of Oregon Health & Science University in Portland and coauthors. Their study was also published in JAMA.
To comprehensively assess PrEP and thus inform the USPSTF’s HIV prevention recommendations, the researchers reviewed criteria-meeting studies on oral PrEP with tenofovir disoproxil fumarate/emtricitabine or tenofovir disoproxil fumarate monotherapy; on the diagnostic accuracy of instruments to predict HIV infection; and on PrEP adherence. The final analysis included 14 randomized clinical trials, 8 observational studies, and 7 studies of diagnostic accuracy.
In 11 of the trials, PrEP was associated with reduced risk of HIV infection versus placebo or no PrEP (relative risk, 0.46; 95% confidence interval, 0.33-0.66). In 6 trials with adherence 70% or greater, the relative risk was 0.27 (95% CI, 0.19-0.39). In 7 studies on risk assessment tools for HIV infection, the instruments had moderate discrimination, though several of the studies had methodological shortcomings. As for serious adverse events, an analysis of 12 trials found no significant difference between PrEP and placebo (RR, 0.93; 95% CI, 0.77-1.12).
Dr. Chou and coauthors noted their study’s limitations, including analyzing English-language articles only and the random-effects model used to pool studies potentially returning narrow CIs. They did note, however, that the “analyses were repeated using the profile likelihood method,” which produced similar findings.
All members of the USPSTF receive travel reimbursement and an honorarium for participating in meetings. The study was funded by the Department of Health and Human Services. One of the authors reported receiving grants from the National Institutes of Health/National Institute on Drug Abuse and serving as principal investigator of NIH-funded clinical trials that received donated drugs from two pharmaceutical companies. No other conflicts of interest were reported.
SOURCE: Owens DK et al. JAMA. 2019 Jun 11. doi: 10.1001/jama.2019.6390; Chou R et al. JAMA. 2019 Jun 11. doi: 10.1001/jama.2019.2591.
To end HIV, guidelines like this one that reflect and promote advances in treatment are needed, according to Hyman Scott, MD, MPH, of the San Francisco Department of Public Health and Paul A. Volberding, MD, of the University of California, San Francisco.
With less than 10% of individuals with an indication for PrEP currently receiving the medication, it is now time to support policies aimed at broadening the access of PrEP to people at risk, the coauthors wrote. They noted that recent USPSTF guidelines show that evidence and policy in HIV medicine has matured not only in the United States but across the globe.
That said, sometimes the simplest solutions are also the best. Though the systematic review from Roger Chou, MD, and associates notes the necessity and importance of adherence, if a clinician thinks that a candidate for PrEP might be nonadherent, that clinicians should not withhold the medication, they wrote. Averting new HIV infections is the goal, and fully endorsing treatments like PrEP is an important step in that direction.*
These comments are adapted from an accompanying editorial (JAMA. 2019 Jun 11. doi: 10.1001/jama.2019.2590). Dr. Volberding reported serving on a data and safety monitoring board for Merck.
*This article was updated on 6/11/2019.
To end HIV, guidelines like this one that reflect and promote advances in treatment are needed, according to Hyman Scott, MD, MPH, of the San Francisco Department of Public Health and Paul A. Volberding, MD, of the University of California, San Francisco.
With less than 10% of individuals with an indication for PrEP currently receiving the medication, it is now time to support policies aimed at broadening the access of PrEP to people at risk, the coauthors wrote. They noted that recent USPSTF guidelines show that evidence and policy in HIV medicine has matured not only in the United States but across the globe.
That said, sometimes the simplest solutions are also the best. Though the systematic review from Roger Chou, MD, and associates notes the necessity and importance of adherence, if a clinician thinks that a candidate for PrEP might be nonadherent, that clinicians should not withhold the medication, they wrote. Averting new HIV infections is the goal, and fully endorsing treatments like PrEP is an important step in that direction.*
These comments are adapted from an accompanying editorial (JAMA. 2019 Jun 11. doi: 10.1001/jama.2019.2590). Dr. Volberding reported serving on a data and safety monitoring board for Merck.
*This article was updated on 6/11/2019.
To end HIV, guidelines like this one that reflect and promote advances in treatment are needed, according to Hyman Scott, MD, MPH, of the San Francisco Department of Public Health and Paul A. Volberding, MD, of the University of California, San Francisco.
With less than 10% of individuals with an indication for PrEP currently receiving the medication, it is now time to support policies aimed at broadening the access of PrEP to people at risk, the coauthors wrote. They noted that recent USPSTF guidelines show that evidence and policy in HIV medicine has matured not only in the United States but across the globe.
That said, sometimes the simplest solutions are also the best. Though the systematic review from Roger Chou, MD, and associates notes the necessity and importance of adherence, if a clinician thinks that a candidate for PrEP might be nonadherent, that clinicians should not withhold the medication, they wrote. Averting new HIV infections is the goal, and fully endorsing treatments like PrEP is an important step in that direction.*
These comments are adapted from an accompanying editorial (JAMA. 2019 Jun 11. doi: 10.1001/jama.2019.2590). Dr. Volberding reported serving on a data and safety monitoring board for Merck.
*This article was updated on 6/11/2019.
Pre-exposure prophylaxis (PrEP) plus effective antiretroviral therapy should be offered to people at high risk of HIV acquisition, according to a new recommendation from the U.S. Preventive Services Task Force (USPSTF).
“The USPSTF concludes with high certainty that the net benefit of the use of PrEP to reduce the risk of acquisition of HIV infection in persons at high risk of HIV infection is substantial,” wrote first author Douglas K. Owens, MD, of Stanford (Calif.) University and fellow members of the USPSTF. The recommendation was published in JAMA.
In various at-risk groups – including men who have sex with men, people at risk through heterosexual contact, and people who inject drugs – the USPSTF recommends a Food and Drug Adminstration–approved, once-daily oral treatment with combined tenofovir disoproxil fumarate and emtricitabine.
This recommendation was developed after a systematic review of PrEP’s effects on HIV, adherence to the treatment, and accuracy in identifying potential treatment candidates. “The findings of this review are generally consistent with those from other recent meta-analyses that found PrEP to be effective at reducing risk of HIV infection and found greater effectiveness in trials reporting higher adherence,” wrote Roger Chou, MD, of Oregon Health & Science University in Portland and coauthors. Their study was also published in JAMA.
To comprehensively assess PrEP and thus inform the USPSTF’s HIV prevention recommendations, the researchers reviewed criteria-meeting studies on oral PrEP with tenofovir disoproxil fumarate/emtricitabine or tenofovir disoproxil fumarate monotherapy; on the diagnostic accuracy of instruments to predict HIV infection; and on PrEP adherence. The final analysis included 14 randomized clinical trials, 8 observational studies, and 7 studies of diagnostic accuracy.
In 11 of the trials, PrEP was associated with reduced risk of HIV infection versus placebo or no PrEP (relative risk, 0.46; 95% confidence interval, 0.33-0.66). In 6 trials with adherence 70% or greater, the relative risk was 0.27 (95% CI, 0.19-0.39). In 7 studies on risk assessment tools for HIV infection, the instruments had moderate discrimination, though several of the studies had methodological shortcomings. As for serious adverse events, an analysis of 12 trials found no significant difference between PrEP and placebo (RR, 0.93; 95% CI, 0.77-1.12).
Dr. Chou and coauthors noted their study’s limitations, including analyzing English-language articles only and the random-effects model used to pool studies potentially returning narrow CIs. They did note, however, that the “analyses were repeated using the profile likelihood method,” which produced similar findings.
All members of the USPSTF receive travel reimbursement and an honorarium for participating in meetings. The study was funded by the Department of Health and Human Services. One of the authors reported receiving grants from the National Institutes of Health/National Institute on Drug Abuse and serving as principal investigator of NIH-funded clinical trials that received donated drugs from two pharmaceutical companies. No other conflicts of interest were reported.
SOURCE: Owens DK et al. JAMA. 2019 Jun 11. doi: 10.1001/jama.2019.6390; Chou R et al. JAMA. 2019 Jun 11. doi: 10.1001/jama.2019.2591.
Pre-exposure prophylaxis (PrEP) plus effective antiretroviral therapy should be offered to people at high risk of HIV acquisition, according to a new recommendation from the U.S. Preventive Services Task Force (USPSTF).
“The USPSTF concludes with high certainty that the net benefit of the use of PrEP to reduce the risk of acquisition of HIV infection in persons at high risk of HIV infection is substantial,” wrote first author Douglas K. Owens, MD, of Stanford (Calif.) University and fellow members of the USPSTF. The recommendation was published in JAMA.
In various at-risk groups – including men who have sex with men, people at risk through heterosexual contact, and people who inject drugs – the USPSTF recommends a Food and Drug Adminstration–approved, once-daily oral treatment with combined tenofovir disoproxil fumarate and emtricitabine.
This recommendation was developed after a systematic review of PrEP’s effects on HIV, adherence to the treatment, and accuracy in identifying potential treatment candidates. “The findings of this review are generally consistent with those from other recent meta-analyses that found PrEP to be effective at reducing risk of HIV infection and found greater effectiveness in trials reporting higher adherence,” wrote Roger Chou, MD, of Oregon Health & Science University in Portland and coauthors. Their study was also published in JAMA.
To comprehensively assess PrEP and thus inform the USPSTF’s HIV prevention recommendations, the researchers reviewed criteria-meeting studies on oral PrEP with tenofovir disoproxil fumarate/emtricitabine or tenofovir disoproxil fumarate monotherapy; on the diagnostic accuracy of instruments to predict HIV infection; and on PrEP adherence. The final analysis included 14 randomized clinical trials, 8 observational studies, and 7 studies of diagnostic accuracy.
In 11 of the trials, PrEP was associated with reduced risk of HIV infection versus placebo or no PrEP (relative risk, 0.46; 95% confidence interval, 0.33-0.66). In 6 trials with adherence 70% or greater, the relative risk was 0.27 (95% CI, 0.19-0.39). In 7 studies on risk assessment tools for HIV infection, the instruments had moderate discrimination, though several of the studies had methodological shortcomings. As for serious adverse events, an analysis of 12 trials found no significant difference between PrEP and placebo (RR, 0.93; 95% CI, 0.77-1.12).
Dr. Chou and coauthors noted their study’s limitations, including analyzing English-language articles only and the random-effects model used to pool studies potentially returning narrow CIs. They did note, however, that the “analyses were repeated using the profile likelihood method,” which produced similar findings.
All members of the USPSTF receive travel reimbursement and an honorarium for participating in meetings. The study was funded by the Department of Health and Human Services. One of the authors reported receiving grants from the National Institutes of Health/National Institute on Drug Abuse and serving as principal investigator of NIH-funded clinical trials that received donated drugs from two pharmaceutical companies. No other conflicts of interest were reported.
SOURCE: Owens DK et al. JAMA. 2019 Jun 11. doi: 10.1001/jama.2019.6390; Chou R et al. JAMA. 2019 Jun 11. doi: 10.1001/jama.2019.2591.
FROM JAMA
Induced seizures as effective as spontaneous in identifying epileptic generator
according to a study of patients with focal drug-resistant epilepsy.
“This finding might lead to a more time-efficient intracranial presurgical investigation of focal epilepsy by reducing the need to record spontaneous seizures,” wrote Carolina Cuello Oderiz, MD, formerly of McGill University, and her coauthors. The study was published in JAMA Neurology.
To determine if cortical stimulation-induced seizures and subsequent removal of the informed seizure-onset zone (SOZ) could lead to good surgical outcomes, the researchers selected 103 patients with focal drug-resistant epilepsy who underwent stereoelectroencephalography (SEEG). All participants had to have undergone cortical stimulation during SEEG, followed by open epilepsy surgical procedure with a minimum 1-year follow-up. In addition, complete brain imaging for exact localization of individual electrode contacts and resection cavity was also required.
Of the 103 patients, 59 (57.3%) had cortical stimulation-induced seizures. The percentage of these patients in the good outcome group was higher than in the poor outcome group (70.5% versus 47.5%). The median percentage of resected cortical stimulation-informed SOZ contacts was also higher in the good than in the poor outcome group (63.2% versus 33.3%). The results were similar for spontaneous seizures, where the median percentage of resected contacts of the spontaneous SOZ was 57.1% in the good outcome group and 32.7% in the poor outcome group.
The coauthors noted their study’s limitations, including the exclusion of many patients due to the need for hi-resolution neuroimaging and sufficient postsurgical imaging and follow-up. They added that the strict criteria were “key to the main outcome of this study,” however, and noted that generalizability of the data was supported by similar rates in excluded patients.
The study was supported by grants from the Canadian Institute of Health Research and the Savoy Epilepsy Foundation. Numerous authors reported receiving grants, personal fees, and other funding from organizations like the Montreal Neurological Institute and various pharmaceutical companies.
Dr. Cuello Oderiz is now at SUNY Upstate Medical University, Syracuse, N.Y.
SOURCE: Cuello Oderiz C et al. JAMA Neurol. 2019 Jun 10. doi: 10.1001/jamaneurol.2019.1464.
according to a study of patients with focal drug-resistant epilepsy.
“This finding might lead to a more time-efficient intracranial presurgical investigation of focal epilepsy by reducing the need to record spontaneous seizures,” wrote Carolina Cuello Oderiz, MD, formerly of McGill University, and her coauthors. The study was published in JAMA Neurology.
To determine if cortical stimulation-induced seizures and subsequent removal of the informed seizure-onset zone (SOZ) could lead to good surgical outcomes, the researchers selected 103 patients with focal drug-resistant epilepsy who underwent stereoelectroencephalography (SEEG). All participants had to have undergone cortical stimulation during SEEG, followed by open epilepsy surgical procedure with a minimum 1-year follow-up. In addition, complete brain imaging for exact localization of individual electrode contacts and resection cavity was also required.
Of the 103 patients, 59 (57.3%) had cortical stimulation-induced seizures. The percentage of these patients in the good outcome group was higher than in the poor outcome group (70.5% versus 47.5%). The median percentage of resected cortical stimulation-informed SOZ contacts was also higher in the good than in the poor outcome group (63.2% versus 33.3%). The results were similar for spontaneous seizures, where the median percentage of resected contacts of the spontaneous SOZ was 57.1% in the good outcome group and 32.7% in the poor outcome group.
The coauthors noted their study’s limitations, including the exclusion of many patients due to the need for hi-resolution neuroimaging and sufficient postsurgical imaging and follow-up. They added that the strict criteria were “key to the main outcome of this study,” however, and noted that generalizability of the data was supported by similar rates in excluded patients.
The study was supported by grants from the Canadian Institute of Health Research and the Savoy Epilepsy Foundation. Numerous authors reported receiving grants, personal fees, and other funding from organizations like the Montreal Neurological Institute and various pharmaceutical companies.
Dr. Cuello Oderiz is now at SUNY Upstate Medical University, Syracuse, N.Y.
SOURCE: Cuello Oderiz C et al. JAMA Neurol. 2019 Jun 10. doi: 10.1001/jamaneurol.2019.1464.
according to a study of patients with focal drug-resistant epilepsy.
“This finding might lead to a more time-efficient intracranial presurgical investigation of focal epilepsy by reducing the need to record spontaneous seizures,” wrote Carolina Cuello Oderiz, MD, formerly of McGill University, and her coauthors. The study was published in JAMA Neurology.
To determine if cortical stimulation-induced seizures and subsequent removal of the informed seizure-onset zone (SOZ) could lead to good surgical outcomes, the researchers selected 103 patients with focal drug-resistant epilepsy who underwent stereoelectroencephalography (SEEG). All participants had to have undergone cortical stimulation during SEEG, followed by open epilepsy surgical procedure with a minimum 1-year follow-up. In addition, complete brain imaging for exact localization of individual electrode contacts and resection cavity was also required.
Of the 103 patients, 59 (57.3%) had cortical stimulation-induced seizures. The percentage of these patients in the good outcome group was higher than in the poor outcome group (70.5% versus 47.5%). The median percentage of resected cortical stimulation-informed SOZ contacts was also higher in the good than in the poor outcome group (63.2% versus 33.3%). The results were similar for spontaneous seizures, where the median percentage of resected contacts of the spontaneous SOZ was 57.1% in the good outcome group and 32.7% in the poor outcome group.
The coauthors noted their study’s limitations, including the exclusion of many patients due to the need for hi-resolution neuroimaging and sufficient postsurgical imaging and follow-up. They added that the strict criteria were “key to the main outcome of this study,” however, and noted that generalizability of the data was supported by similar rates in excluded patients.
The study was supported by grants from the Canadian Institute of Health Research and the Savoy Epilepsy Foundation. Numerous authors reported receiving grants, personal fees, and other funding from organizations like the Montreal Neurological Institute and various pharmaceutical companies.
Dr. Cuello Oderiz is now at SUNY Upstate Medical University, Syracuse, N.Y.
SOURCE: Cuello Oderiz C et al. JAMA Neurol. 2019 Jun 10. doi: 10.1001/jamaneurol.2019.1464.
FROM JAMA NEUROLOGY
Key clinical point: Seizures induced by cortical stimulation and spontaneous seizures both led to a similar percentage of good surgical outcomes in patients with epilepsy.
Major finding: The percentage of patients who received cortical stimulation-induced seizures in the good outcome group was higher than in the poor outcome group (70.5% versus 47.5%).
Study details: A cohort study of 103 patients with focal drug-resistant epilepsy who underwent stereoelectroencephalography.
Disclosures: The study was supported by grants from the Canadian Institute of Health Research and the Savoy Epilepsy Foundation. Numerous authors reported receiving grants, personal fees, and other funding from organizations like the Montreal Neurological Institute and various pharmaceutical companies.
Source: Cuello Oderiz C et al. JAMA Neurol. 2019 Jun 10. doi: 10.1001/jamaneurol.2019.1464.
Topical calcineurin inhibitors prove beneficial for patients with vitiligo
Though responses to topical calcineurin inhibitors (TCIs) plus phototherapy were found to be higher than TCI monotherapy, a meta-analysis of studies on TCI therapy found that both should be used in treatment for patients with vitiligo.
“In addition, the proactive use of TCIs to maintain remission of vitiligo could be promising, considering its high recurrence rate,” wrote Ji Hae Lee, MD, PhD, of the Catholic University of Korea, Seoul, and coauthors in JAMA Dermatology.
To assess TCIs as treatment for vitiligo, the researchers undertook a systematic review and analysis of 56 relevant studies. Eleven of the studies were on the TCI mechanism; 36 were on TCI monotherapy; 12 were on TCI plus phototherapy; and 1 was on TCI maintenance therapy. Treatment responses for each study were measured via the degree of repigmentation on a quartile scale: an at least mild response (25% or greater repigmentation), at least moderate response (50% or greater repigmentation), and marked response (75% or greater repigmentation).
In regard to TCI monotherapy, an at least mild response was achieved in 55% (95% confidence interval, 42.2%-67.8%) of 560 patients in 21 studies. An at least moderate response was achieved in 38.5% (95% CI, 28.2%-48.8%) of 619 patients in 23 studies, and there was a marked response in 18.1% (95% CI, 13.2%-23.1%) of 520 patients in 19 studies.
For TCI plus phototherapy, an at least mild response was achieved in 89.5% (95% CI, 81.1%-97.9%) of 433 patients in eight studies. An at least moderate response was achieved in 72.9% (95% CI, 57.6%-88.2%) of 486 patients in 10 studies, and a marked response was achieved in 47.5% (95% CI, 30.6%-64.4%) of 490 patients in 9 studies.
The authors noted several limitations with their review, including a level of heterogeneity in the study designs, characteristics of the patients, and protocols. They also acknowledged that the quartile scale may be somewhat arbitrary in nature, though they added that it has been the “most commonly used measure and would have been one of the best estimates of the treatment response at this time.”
The authors report no conflicts of interest.
SOURCE: Lee JH et al. Jama Dermatol. 2019 May 29. doi: 10.1001/Jamadermatol.2019.0696.
Though responses to topical calcineurin inhibitors (TCIs) plus phototherapy were found to be higher than TCI monotherapy, a meta-analysis of studies on TCI therapy found that both should be used in treatment for patients with vitiligo.
“In addition, the proactive use of TCIs to maintain remission of vitiligo could be promising, considering its high recurrence rate,” wrote Ji Hae Lee, MD, PhD, of the Catholic University of Korea, Seoul, and coauthors in JAMA Dermatology.
To assess TCIs as treatment for vitiligo, the researchers undertook a systematic review and analysis of 56 relevant studies. Eleven of the studies were on the TCI mechanism; 36 were on TCI monotherapy; 12 were on TCI plus phototherapy; and 1 was on TCI maintenance therapy. Treatment responses for each study were measured via the degree of repigmentation on a quartile scale: an at least mild response (25% or greater repigmentation), at least moderate response (50% or greater repigmentation), and marked response (75% or greater repigmentation).
In regard to TCI monotherapy, an at least mild response was achieved in 55% (95% confidence interval, 42.2%-67.8%) of 560 patients in 21 studies. An at least moderate response was achieved in 38.5% (95% CI, 28.2%-48.8%) of 619 patients in 23 studies, and there was a marked response in 18.1% (95% CI, 13.2%-23.1%) of 520 patients in 19 studies.
For TCI plus phototherapy, an at least mild response was achieved in 89.5% (95% CI, 81.1%-97.9%) of 433 patients in eight studies. An at least moderate response was achieved in 72.9% (95% CI, 57.6%-88.2%) of 486 patients in 10 studies, and a marked response was achieved in 47.5% (95% CI, 30.6%-64.4%) of 490 patients in 9 studies.
The authors noted several limitations with their review, including a level of heterogeneity in the study designs, characteristics of the patients, and protocols. They also acknowledged that the quartile scale may be somewhat arbitrary in nature, though they added that it has been the “most commonly used measure and would have been one of the best estimates of the treatment response at this time.”
The authors report no conflicts of interest.
SOURCE: Lee JH et al. Jama Dermatol. 2019 May 29. doi: 10.1001/Jamadermatol.2019.0696.
Though responses to topical calcineurin inhibitors (TCIs) plus phototherapy were found to be higher than TCI monotherapy, a meta-analysis of studies on TCI therapy found that both should be used in treatment for patients with vitiligo.
“In addition, the proactive use of TCIs to maintain remission of vitiligo could be promising, considering its high recurrence rate,” wrote Ji Hae Lee, MD, PhD, of the Catholic University of Korea, Seoul, and coauthors in JAMA Dermatology.
To assess TCIs as treatment for vitiligo, the researchers undertook a systematic review and analysis of 56 relevant studies. Eleven of the studies were on the TCI mechanism; 36 were on TCI monotherapy; 12 were on TCI plus phototherapy; and 1 was on TCI maintenance therapy. Treatment responses for each study were measured via the degree of repigmentation on a quartile scale: an at least mild response (25% or greater repigmentation), at least moderate response (50% or greater repigmentation), and marked response (75% or greater repigmentation).
In regard to TCI monotherapy, an at least mild response was achieved in 55% (95% confidence interval, 42.2%-67.8%) of 560 patients in 21 studies. An at least moderate response was achieved in 38.5% (95% CI, 28.2%-48.8%) of 619 patients in 23 studies, and there was a marked response in 18.1% (95% CI, 13.2%-23.1%) of 520 patients in 19 studies.
For TCI plus phototherapy, an at least mild response was achieved in 89.5% (95% CI, 81.1%-97.9%) of 433 patients in eight studies. An at least moderate response was achieved in 72.9% (95% CI, 57.6%-88.2%) of 486 patients in 10 studies, and a marked response was achieved in 47.5% (95% CI, 30.6%-64.4%) of 490 patients in 9 studies.
The authors noted several limitations with their review, including a level of heterogeneity in the study designs, characteristics of the patients, and protocols. They also acknowledged that the quartile scale may be somewhat arbitrary in nature, though they added that it has been the “most commonly used measure and would have been one of the best estimates of the treatment response at this time.”
The authors report no conflicts of interest.
SOURCE: Lee JH et al. Jama Dermatol. 2019 May 29. doi: 10.1001/Jamadermatol.2019.0696.
FROM JAMA Dermatology
Energy drinks increase BP and disrupt the heart’s electrical activity
Consuming caffeinated energy drinks leads to a prolonged QT interval and an increase in blood pressure, according to a study of young volunteers who had their hearts tested after drinking either energy drinks or placebo.
“Further investigation is warranted on whether an individual ingredient or a unique combination leads to the observed electrophysiological and hemodynamic changes,” wrote Sachin A. Shah of the University of the Pacific, Stockton, Calif., and coinvestigators. The study was published in the Journal of the American Heart Association.
To analyze electrocardiographic changes in the heart after consumption of 300 mg of caffeine plus other energy drink ingredients, the researchers assigned 34 healthy volunteers with an average age of 22 years to consume two 16-ounce bottles of either Drink A, a commercially available energy drink, Drink B, a different brand of energy drink, or a placebo drink for 3 days, followed by a 6-day washout period. Before and for 4 hours after consuming the beverages, volunteers had their hearts measured via ECG to test for differences in QT interval. Their blood pressures also were recorded.
Compared with placebo, the Drink A group had a 6.1 ms increase in QT interval and the Drink B group had a 7.7 ms rise. The maximum changes from baseline in corrected QT interval for Drink A, Drink B, and placebo were 17.9 ms, 19.6 ms, and 11.9 ms, respectively; both differences were statistically significant. Volunteers in Drink A and Drink B groups also had statistically significant increases of 5 mm Hg in systolic and 4 mm Hg in diastolic blood pressure after energy drink consumption, compared with placebo.
Both energy drinks used in the study contained caffeine (about 300 mg), taurine, glucuronolactone, and B vitamins. The investigators said that caffeine at doses under 400 mg is not expected to induce any electrocardiographic changes.
The coauthors noted their study’s limitations, including not investigating the effects of different doses and the possibility that consuming two 16-ounce bottles is an unrealistic real-world volume. That said, they noted that 16% of respondents to a 2,040-person survey admitted to consuming more than two energy drinks a day. In addition, though not every brand was tested, the researchers stated that, “the class of energy drinks, rather than one particular product, warrants use with caution.”
Dr. Shah reported serving as an expert witness in legal cases related to caffeinated energy drinks. The other authors reported no conflicts of interest.
SOURCE: Shah SA et al. J Am Heart Assoc. 2019 May 29.
Consuming caffeinated energy drinks leads to a prolonged QT interval and an increase in blood pressure, according to a study of young volunteers who had their hearts tested after drinking either energy drinks or placebo.
“Further investigation is warranted on whether an individual ingredient or a unique combination leads to the observed electrophysiological and hemodynamic changes,” wrote Sachin A. Shah of the University of the Pacific, Stockton, Calif., and coinvestigators. The study was published in the Journal of the American Heart Association.
To analyze electrocardiographic changes in the heart after consumption of 300 mg of caffeine plus other energy drink ingredients, the researchers assigned 34 healthy volunteers with an average age of 22 years to consume two 16-ounce bottles of either Drink A, a commercially available energy drink, Drink B, a different brand of energy drink, or a placebo drink for 3 days, followed by a 6-day washout period. Before and for 4 hours after consuming the beverages, volunteers had their hearts measured via ECG to test for differences in QT interval. Their blood pressures also were recorded.
Compared with placebo, the Drink A group had a 6.1 ms increase in QT interval and the Drink B group had a 7.7 ms rise. The maximum changes from baseline in corrected QT interval for Drink A, Drink B, and placebo were 17.9 ms, 19.6 ms, and 11.9 ms, respectively; both differences were statistically significant. Volunteers in Drink A and Drink B groups also had statistically significant increases of 5 mm Hg in systolic and 4 mm Hg in diastolic blood pressure after energy drink consumption, compared with placebo.
Both energy drinks used in the study contained caffeine (about 300 mg), taurine, glucuronolactone, and B vitamins. The investigators said that caffeine at doses under 400 mg is not expected to induce any electrocardiographic changes.
The coauthors noted their study’s limitations, including not investigating the effects of different doses and the possibility that consuming two 16-ounce bottles is an unrealistic real-world volume. That said, they noted that 16% of respondents to a 2,040-person survey admitted to consuming more than two energy drinks a day. In addition, though not every brand was tested, the researchers stated that, “the class of energy drinks, rather than one particular product, warrants use with caution.”
Dr. Shah reported serving as an expert witness in legal cases related to caffeinated energy drinks. The other authors reported no conflicts of interest.
SOURCE: Shah SA et al. J Am Heart Assoc. 2019 May 29.
Consuming caffeinated energy drinks leads to a prolonged QT interval and an increase in blood pressure, according to a study of young volunteers who had their hearts tested after drinking either energy drinks or placebo.
“Further investigation is warranted on whether an individual ingredient or a unique combination leads to the observed electrophysiological and hemodynamic changes,” wrote Sachin A. Shah of the University of the Pacific, Stockton, Calif., and coinvestigators. The study was published in the Journal of the American Heart Association.
To analyze electrocardiographic changes in the heart after consumption of 300 mg of caffeine plus other energy drink ingredients, the researchers assigned 34 healthy volunteers with an average age of 22 years to consume two 16-ounce bottles of either Drink A, a commercially available energy drink, Drink B, a different brand of energy drink, or a placebo drink for 3 days, followed by a 6-day washout period. Before and for 4 hours after consuming the beverages, volunteers had their hearts measured via ECG to test for differences in QT interval. Their blood pressures also were recorded.
Compared with placebo, the Drink A group had a 6.1 ms increase in QT interval and the Drink B group had a 7.7 ms rise. The maximum changes from baseline in corrected QT interval for Drink A, Drink B, and placebo were 17.9 ms, 19.6 ms, and 11.9 ms, respectively; both differences were statistically significant. Volunteers in Drink A and Drink B groups also had statistically significant increases of 5 mm Hg in systolic and 4 mm Hg in diastolic blood pressure after energy drink consumption, compared with placebo.
Both energy drinks used in the study contained caffeine (about 300 mg), taurine, glucuronolactone, and B vitamins. The investigators said that caffeine at doses under 400 mg is not expected to induce any electrocardiographic changes.
The coauthors noted their study’s limitations, including not investigating the effects of different doses and the possibility that consuming two 16-ounce bottles is an unrealistic real-world volume. That said, they noted that 16% of respondents to a 2,040-person survey admitted to consuming more than two energy drinks a day. In addition, though not every brand was tested, the researchers stated that, “the class of energy drinks, rather than one particular product, warrants use with caution.”
Dr. Shah reported serving as an expert witness in legal cases related to caffeinated energy drinks. The other authors reported no conflicts of interest.
SOURCE: Shah SA et al. J Am Heart Assoc. 2019 May 29.
FROM THE JOURNAL OF THE AMERICAN HEART ASSOCIATION
Key clinical point:
Major finding: Compared with placebo, consuming two different energy drinks led to significant QT interval increases of 6.1 ms and 7.7 ms.
Study details: A randomized, double-blind crossover study of 34 healthy volunteers who had their hearts measured via electrocardiogram after consuming energy drink or placebo.
Disclosures: Dr. Shah reported serving as an expert witness in legal cases related to caffeinated energy drinks. The other authors reported no conflicts of interest.
Source: Shah SA et al. J Am Heart Assoc. 2019 May 29.
Study finds inconsistent links with aspirin, nonaspirin NSAIDs and reduced skin cancer risk
Use of aspirin or nonaspirin NSAIDs was not associated with a reduced risk of basal cell carcinoma (BCC) or squamous cell carcinoma (SCC), in a large, prospective cohort study of Australian residents.
“Overall, we observed weak and inconsistent inverse associations between use of these medications and incidence of either BCC or SCC,” wrote Nirmala Pandeya, PhD, of the University of Queensland (Australia) and coauthors. “While we did observe a modest reduction in use,” they added. The study was published in the British Journal of Dermatology.
While reviews of observational studies have suggested that NSAIDs may have “a potential benefit” in reducing the incidence of BCC and SCC, the results have varied, they noted.
To investigate the potential chemopreventive effects of NSAID use on skin cancer, the investigators used data from the QSkin Sun and Health Study, a prospective cohort of 43,764 residents of Queensland, Australia. Those eligible for the study had a white ethnic background and no history of melanoma; 34,630 participants were available for analysis, their median age was 57 years, and 55% were women
Almost 15,600 (45%) were classified as “high risk” because they had had at least one skin cancer excision or more than five actinic lesions treated; 18,828 participants were classified as “average to low risk;” and data were unavailable for 206 participants. One‐third of the participants in the high-risk group (5,398) used aspirin; of these individuals, 39% (2,132) used aspirin more than once a week (defined as “frequent” users). Also, 60% (9,236) used NSAIDs, and of those, 24% (2,229) were frequent users.
During a median follow-up of 3 years, 3,421 of those in the study (10%) developed one or more BCC, and 1,470 (4%) developed one or more SCC.
Compared with never users, frequent NSAID use in the high-risk group was modestly associated with a reduced risk of BCC (hazard ratio, 0.84; 95% confidence interval, 0.71-0.99), but not with SCC. Aspirin use was weakly associated with a reduced risk of SCC (HR, 0.77; 95% CI, 0.64-0.93) but only among infrequent users and was not associated with BCC risk. In the average- to low-risk group, there was no association with either NSAIDs or aspirin and BCC or SCC occurrence.
The authors noted limitations of their study, including its reliance on self-reported NSAID use and a lack of detail in regard to usage dose and duration. In addition, though the investigators controlled for all likely confounders, “the possibility of some residual confounding cannot be excluded.”
The QSkin Study was funded by a grant from the National Health and Medical Research Council of Australia (NHMRC). The authors declared no conflicts of interest.
SOURCE: Pandeya N et al. Br J Dermatol. 2019 Mar 28. doi: 10.1111/bjd.17938.
Use of aspirin or nonaspirin NSAIDs was not associated with a reduced risk of basal cell carcinoma (BCC) or squamous cell carcinoma (SCC), in a large, prospective cohort study of Australian residents.
“Overall, we observed weak and inconsistent inverse associations between use of these medications and incidence of either BCC or SCC,” wrote Nirmala Pandeya, PhD, of the University of Queensland (Australia) and coauthors. “While we did observe a modest reduction in use,” they added. The study was published in the British Journal of Dermatology.
While reviews of observational studies have suggested that NSAIDs may have “a potential benefit” in reducing the incidence of BCC and SCC, the results have varied, they noted.
To investigate the potential chemopreventive effects of NSAID use on skin cancer, the investigators used data from the QSkin Sun and Health Study, a prospective cohort of 43,764 residents of Queensland, Australia. Those eligible for the study had a white ethnic background and no history of melanoma; 34,630 participants were available for analysis, their median age was 57 years, and 55% were women
Almost 15,600 (45%) were classified as “high risk” because they had had at least one skin cancer excision or more than five actinic lesions treated; 18,828 participants were classified as “average to low risk;” and data were unavailable for 206 participants. One‐third of the participants in the high-risk group (5,398) used aspirin; of these individuals, 39% (2,132) used aspirin more than once a week (defined as “frequent” users). Also, 60% (9,236) used NSAIDs, and of those, 24% (2,229) were frequent users.
During a median follow-up of 3 years, 3,421 of those in the study (10%) developed one or more BCC, and 1,470 (4%) developed one or more SCC.
Compared with never users, frequent NSAID use in the high-risk group was modestly associated with a reduced risk of BCC (hazard ratio, 0.84; 95% confidence interval, 0.71-0.99), but not with SCC. Aspirin use was weakly associated with a reduced risk of SCC (HR, 0.77; 95% CI, 0.64-0.93) but only among infrequent users and was not associated with BCC risk. In the average- to low-risk group, there was no association with either NSAIDs or aspirin and BCC or SCC occurrence.
The authors noted limitations of their study, including its reliance on self-reported NSAID use and a lack of detail in regard to usage dose and duration. In addition, though the investigators controlled for all likely confounders, “the possibility of some residual confounding cannot be excluded.”
The QSkin Study was funded by a grant from the National Health and Medical Research Council of Australia (NHMRC). The authors declared no conflicts of interest.
SOURCE: Pandeya N et al. Br J Dermatol. 2019 Mar 28. doi: 10.1111/bjd.17938.
Use of aspirin or nonaspirin NSAIDs was not associated with a reduced risk of basal cell carcinoma (BCC) or squamous cell carcinoma (SCC), in a large, prospective cohort study of Australian residents.
“Overall, we observed weak and inconsistent inverse associations between use of these medications and incidence of either BCC or SCC,” wrote Nirmala Pandeya, PhD, of the University of Queensland (Australia) and coauthors. “While we did observe a modest reduction in use,” they added. The study was published in the British Journal of Dermatology.
While reviews of observational studies have suggested that NSAIDs may have “a potential benefit” in reducing the incidence of BCC and SCC, the results have varied, they noted.
To investigate the potential chemopreventive effects of NSAID use on skin cancer, the investigators used data from the QSkin Sun and Health Study, a prospective cohort of 43,764 residents of Queensland, Australia. Those eligible for the study had a white ethnic background and no history of melanoma; 34,630 participants were available for analysis, their median age was 57 years, and 55% were women
Almost 15,600 (45%) were classified as “high risk” because they had had at least one skin cancer excision or more than five actinic lesions treated; 18,828 participants were classified as “average to low risk;” and data were unavailable for 206 participants. One‐third of the participants in the high-risk group (5,398) used aspirin; of these individuals, 39% (2,132) used aspirin more than once a week (defined as “frequent” users). Also, 60% (9,236) used NSAIDs, and of those, 24% (2,229) were frequent users.
During a median follow-up of 3 years, 3,421 of those in the study (10%) developed one or more BCC, and 1,470 (4%) developed one or more SCC.
Compared with never users, frequent NSAID use in the high-risk group was modestly associated with a reduced risk of BCC (hazard ratio, 0.84; 95% confidence interval, 0.71-0.99), but not with SCC. Aspirin use was weakly associated with a reduced risk of SCC (HR, 0.77; 95% CI, 0.64-0.93) but only among infrequent users and was not associated with BCC risk. In the average- to low-risk group, there was no association with either NSAIDs or aspirin and BCC or SCC occurrence.
The authors noted limitations of their study, including its reliance on self-reported NSAID use and a lack of detail in regard to usage dose and duration. In addition, though the investigators controlled for all likely confounders, “the possibility of some residual confounding cannot be excluded.”
The QSkin Study was funded by a grant from the National Health and Medical Research Council of Australia (NHMRC). The authors declared no conflicts of interest.
SOURCE: Pandeya N et al. Br J Dermatol. 2019 Mar 28. doi: 10.1111/bjd.17938.
FROM THE BRITISH JOURNAL OF DERMATOLOGY
Diabetes, hypertension remission more prevalent in adolescents than adults after gastric bypass
according to two related studies of 5-year outcomes after Roux-en-Y gastric bypass.
However, despite adolescents’ better outcomes for diabetes and hypertension, their rate of abdominal reoperations was significantly higher during the 5-year follow-up period, and at 2 years post surgery, they were found to have low ferritin levels. The rates of death were similar in the two groups at 5 years.
“We have documented similar and durable weight loss after gastric bypass in adolescents and adults, but important differences between these cohorts were observed in specific health outcomes,” wrote Thomas H. Inge, MD, PhD, of the University of Colorado at Denver, Aurora, and his coauthors. The study was published in the New England Journal of Medicine.
To evaluate and compare outcomes after bariatric surgery, the researchers undertook the Teen–Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study and the LABS study. The two were related but independent observational studies of postsurgery patient cohorts. The Teen-LABS study included 161 adolescents with severe obesity, and the LABS study included 396 adults who reported becoming obese during adolescence.
At 5-year follow-up, there was no significant difference in mean percentage weight change between adolescents (−26%; 95% confidence interval, −29 to −23) and adults (−29%; 95% CI, −31 to −27; P = .08). Adolescents were more likely than were adults to have remission of type 2 diabetes (86% vs. 53%, respectively; risk ratio, 1.27; 95% CI, 1.03 to 1.57; P = .03) as well as hypertension (68% vs. 41%; risk ratio, 1.51; 95% CI, 1.21 to 1.88; P less than .001).
In addition, 20% of adolescents and 16% of adults underwent intra-abdominal procedures within 5 years of surgery, with cholecystectomy being the most common, followed by surgery for bowel obstruction or hernia repair, and gastrostomy. At 2 years, ferritin levels were lower in adolescents than in adults (48% of patients vs. 29%, respectively). Five-year ferritin levels were not assessed.
In all, three adolescents (1.9%) and seven adults (1.8%) died over the 5-year period. Among the adolescents, one patient with type 1 diabetes died 3 years after surgery from complications after a hypoglycemic episode, and the other two deaths, both 4 years after surgery, were consistent with overdose. Among the adults, three of the deaths occurred within 3 weeks of surgery and were related to gastric bypass, two were of indeterminate cause (at 11 months and 5 years after surgery), one was by suicide at 3 years, and one was from colon cancer at 4 years.
The authors acknowledged the limitations of their study, including its observational design, low counts for some of the outcomes, and a lack of nonsurgical controls. They also noted potential unmeasured biases in the adult cohort, including the effects of weight cycling and inaccuracies in recalling adolescent weight issues.
The study and several of its authors were supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. Several authors reported receiving grants, honoraria, and consulting fees from medical technology and pharmaceutical companies.
SOURCE: Inge TH et al. N Engl J Med. 2019 May 16. doi: 10.1056/NEJMoa1813909.
For obese adolescents, making a decision with lifelong consequences, as is the case with bariatric surgery, should still be handled on a case-by-case basis, according to Ted D. Adams, PhD, of the University of Utah, Salt Lake City.
In general, treatment approaches for children and adults differ because of their physiological and psychological differences, but that does not apply in the case of obesity, wrote Dr. Adams, who noted the similarities in obesity across age groups. In addition, he said, most adolescents who are obese remain obese into adulthood, and obese adults who were obese when they were younger face worse outcomes than do those who become obese in adulthood.
As such, this study from Dr. Inge and his colleagues is clinically important given the prevalence of obesity in the United States and a step in the right direction. However, Dr. Adams acknowledged concerns over certain elements, including the higher rate of abdominal reoperations in adolescents during the 5-year postsurgery period.
For now, a case-by-case basis remains his recommendation. “More complete data will be required to fully inform clinicians, parents, and adolescents whether to embark on surgical intervention or to postpone it,” he wrote, adding that “the 5-year data look promising but ... the lifetime outcome is unknown.”
These comments are adapted from an editorial (N Engl J Med. 2019 May 16. doi: 10.1056/NEJMe1905778 ). Dr. Adams reported receiving grants from the National Institute of Diabetes and Digestive and Kidney Diseases as well as the Intermountain Research Foundation and Ethicon Endo-Surgery, a subsidiary of Johnson & Johnson.
For obese adolescents, making a decision with lifelong consequences, as is the case with bariatric surgery, should still be handled on a case-by-case basis, according to Ted D. Adams, PhD, of the University of Utah, Salt Lake City.
In general, treatment approaches for children and adults differ because of their physiological and psychological differences, but that does not apply in the case of obesity, wrote Dr. Adams, who noted the similarities in obesity across age groups. In addition, he said, most adolescents who are obese remain obese into adulthood, and obese adults who were obese when they were younger face worse outcomes than do those who become obese in adulthood.
As such, this study from Dr. Inge and his colleagues is clinically important given the prevalence of obesity in the United States and a step in the right direction. However, Dr. Adams acknowledged concerns over certain elements, including the higher rate of abdominal reoperations in adolescents during the 5-year postsurgery period.
For now, a case-by-case basis remains his recommendation. “More complete data will be required to fully inform clinicians, parents, and adolescents whether to embark on surgical intervention or to postpone it,” he wrote, adding that “the 5-year data look promising but ... the lifetime outcome is unknown.”
These comments are adapted from an editorial (N Engl J Med. 2019 May 16. doi: 10.1056/NEJMe1905778 ). Dr. Adams reported receiving grants from the National Institute of Diabetes and Digestive and Kidney Diseases as well as the Intermountain Research Foundation and Ethicon Endo-Surgery, a subsidiary of Johnson & Johnson.
For obese adolescents, making a decision with lifelong consequences, as is the case with bariatric surgery, should still be handled on a case-by-case basis, according to Ted D. Adams, PhD, of the University of Utah, Salt Lake City.
In general, treatment approaches for children and adults differ because of their physiological and psychological differences, but that does not apply in the case of obesity, wrote Dr. Adams, who noted the similarities in obesity across age groups. In addition, he said, most adolescents who are obese remain obese into adulthood, and obese adults who were obese when they were younger face worse outcomes than do those who become obese in adulthood.
As such, this study from Dr. Inge and his colleagues is clinically important given the prevalence of obesity in the United States and a step in the right direction. However, Dr. Adams acknowledged concerns over certain elements, including the higher rate of abdominal reoperations in adolescents during the 5-year postsurgery period.
For now, a case-by-case basis remains his recommendation. “More complete data will be required to fully inform clinicians, parents, and adolescents whether to embark on surgical intervention or to postpone it,” he wrote, adding that “the 5-year data look promising but ... the lifetime outcome is unknown.”
These comments are adapted from an editorial (N Engl J Med. 2019 May 16. doi: 10.1056/NEJMe1905778 ). Dr. Adams reported receiving grants from the National Institute of Diabetes and Digestive and Kidney Diseases as well as the Intermountain Research Foundation and Ethicon Endo-Surgery, a subsidiary of Johnson & Johnson.
according to two related studies of 5-year outcomes after Roux-en-Y gastric bypass.
However, despite adolescents’ better outcomes for diabetes and hypertension, their rate of abdominal reoperations was significantly higher during the 5-year follow-up period, and at 2 years post surgery, they were found to have low ferritin levels. The rates of death were similar in the two groups at 5 years.
“We have documented similar and durable weight loss after gastric bypass in adolescents and adults, but important differences between these cohorts were observed in specific health outcomes,” wrote Thomas H. Inge, MD, PhD, of the University of Colorado at Denver, Aurora, and his coauthors. The study was published in the New England Journal of Medicine.
To evaluate and compare outcomes after bariatric surgery, the researchers undertook the Teen–Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study and the LABS study. The two were related but independent observational studies of postsurgery patient cohorts. The Teen-LABS study included 161 adolescents with severe obesity, and the LABS study included 396 adults who reported becoming obese during adolescence.
At 5-year follow-up, there was no significant difference in mean percentage weight change between adolescents (−26%; 95% confidence interval, −29 to −23) and adults (−29%; 95% CI, −31 to −27; P = .08). Adolescents were more likely than were adults to have remission of type 2 diabetes (86% vs. 53%, respectively; risk ratio, 1.27; 95% CI, 1.03 to 1.57; P = .03) as well as hypertension (68% vs. 41%; risk ratio, 1.51; 95% CI, 1.21 to 1.88; P less than .001).
In addition, 20% of adolescents and 16% of adults underwent intra-abdominal procedures within 5 years of surgery, with cholecystectomy being the most common, followed by surgery for bowel obstruction or hernia repair, and gastrostomy. At 2 years, ferritin levels were lower in adolescents than in adults (48% of patients vs. 29%, respectively). Five-year ferritin levels were not assessed.
In all, three adolescents (1.9%) and seven adults (1.8%) died over the 5-year period. Among the adolescents, one patient with type 1 diabetes died 3 years after surgery from complications after a hypoglycemic episode, and the other two deaths, both 4 years after surgery, were consistent with overdose. Among the adults, three of the deaths occurred within 3 weeks of surgery and were related to gastric bypass, two were of indeterminate cause (at 11 months and 5 years after surgery), one was by suicide at 3 years, and one was from colon cancer at 4 years.
The authors acknowledged the limitations of their study, including its observational design, low counts for some of the outcomes, and a lack of nonsurgical controls. They also noted potential unmeasured biases in the adult cohort, including the effects of weight cycling and inaccuracies in recalling adolescent weight issues.
The study and several of its authors were supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. Several authors reported receiving grants, honoraria, and consulting fees from medical technology and pharmaceutical companies.
SOURCE: Inge TH et al. N Engl J Med. 2019 May 16. doi: 10.1056/NEJMoa1813909.
according to two related studies of 5-year outcomes after Roux-en-Y gastric bypass.
However, despite adolescents’ better outcomes for diabetes and hypertension, their rate of abdominal reoperations was significantly higher during the 5-year follow-up period, and at 2 years post surgery, they were found to have low ferritin levels. The rates of death were similar in the two groups at 5 years.
“We have documented similar and durable weight loss after gastric bypass in adolescents and adults, but important differences between these cohorts were observed in specific health outcomes,” wrote Thomas H. Inge, MD, PhD, of the University of Colorado at Denver, Aurora, and his coauthors. The study was published in the New England Journal of Medicine.
To evaluate and compare outcomes after bariatric surgery, the researchers undertook the Teen–Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study and the LABS study. The two were related but independent observational studies of postsurgery patient cohorts. The Teen-LABS study included 161 adolescents with severe obesity, and the LABS study included 396 adults who reported becoming obese during adolescence.
At 5-year follow-up, there was no significant difference in mean percentage weight change between adolescents (−26%; 95% confidence interval, −29 to −23) and adults (−29%; 95% CI, −31 to −27; P = .08). Adolescents were more likely than were adults to have remission of type 2 diabetes (86% vs. 53%, respectively; risk ratio, 1.27; 95% CI, 1.03 to 1.57; P = .03) as well as hypertension (68% vs. 41%; risk ratio, 1.51; 95% CI, 1.21 to 1.88; P less than .001).
In addition, 20% of adolescents and 16% of adults underwent intra-abdominal procedures within 5 years of surgery, with cholecystectomy being the most common, followed by surgery for bowel obstruction or hernia repair, and gastrostomy. At 2 years, ferritin levels were lower in adolescents than in adults (48% of patients vs. 29%, respectively). Five-year ferritin levels were not assessed.
In all, three adolescents (1.9%) and seven adults (1.8%) died over the 5-year period. Among the adolescents, one patient with type 1 diabetes died 3 years after surgery from complications after a hypoglycemic episode, and the other two deaths, both 4 years after surgery, were consistent with overdose. Among the adults, three of the deaths occurred within 3 weeks of surgery and were related to gastric bypass, two were of indeterminate cause (at 11 months and 5 years after surgery), one was by suicide at 3 years, and one was from colon cancer at 4 years.
The authors acknowledged the limitations of their study, including its observational design, low counts for some of the outcomes, and a lack of nonsurgical controls. They also noted potential unmeasured biases in the adult cohort, including the effects of weight cycling and inaccuracies in recalling adolescent weight issues.
The study and several of its authors were supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. Several authors reported receiving grants, honoraria, and consulting fees from medical technology and pharmaceutical companies.
SOURCE: Inge TH et al. N Engl J Med. 2019 May 16. doi: 10.1056/NEJMoa1813909.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Patients lack confidence in their skin self-exam abilities
Elderly patients with a history of localized melanoma recognized the importance of skin self-examination (SSE), but expressed low confidence in their abilities to do it correctly, based on results of a small study. While many were willing to use teledermoscopy to assist them in self-exams, patients still preferred to rely on regularly scheduled exams by physicians.
“Low confidence in SSE is a key barrier to patient-led surveillance and to the use of digital technologies for SSE,” wrote Mbathio Dieng, PhD, of the University of Sydney and her coauthors in a study published in JAMA Dermatology.
The Australian researchers conducted semistructured interviews with 37 patients from Sydney. Patients’ median age was 67 years; 26 of 37 (70%) were men.
Barriers to SSE included a perceived lack of competence in self-exams; the patients said they doubted they would catch anything that needed to be caught.
As for digitally supported SSE, many patients expressed a willingness to consider tools that would assist in the self-assessment process. Several said they valued the additional reassurance between clinical visits and the ability to create their own action plan.
The authors acknowledged that they only recruited from a single tertiary center so the results are limited. However, in terms of steps forward, they noted that their study was one of the first “to assess the perceptions of patients with melanoma of the use of new digital technologies in surveillance for recurrent or new primary melanomas.”
The study was supported by a grant from the Australian National Health and Medical Research Council (NHMRC). One author reported receiving salary support from an Australian NHMRC fellowship; another received fellowships from the NHMRC and Cancer Institute New South Wales. Another author received scholarships and awards from the University of Sydney and the Sydney Catalyst Translational Cancer Research Centre.
SOURCE: Dieng M et al. JAMA Dermatol. 2019 May 15. doi: 10.1001/jamadermatol.2019.0434.
Elderly patients with a history of localized melanoma recognized the importance of skin self-examination (SSE), but expressed low confidence in their abilities to do it correctly, based on results of a small study. While many were willing to use teledermoscopy to assist them in self-exams, patients still preferred to rely on regularly scheduled exams by physicians.
“Low confidence in SSE is a key barrier to patient-led surveillance and to the use of digital technologies for SSE,” wrote Mbathio Dieng, PhD, of the University of Sydney and her coauthors in a study published in JAMA Dermatology.
The Australian researchers conducted semistructured interviews with 37 patients from Sydney. Patients’ median age was 67 years; 26 of 37 (70%) were men.
Barriers to SSE included a perceived lack of competence in self-exams; the patients said they doubted they would catch anything that needed to be caught.
As for digitally supported SSE, many patients expressed a willingness to consider tools that would assist in the self-assessment process. Several said they valued the additional reassurance between clinical visits and the ability to create their own action plan.
The authors acknowledged that they only recruited from a single tertiary center so the results are limited. However, in terms of steps forward, they noted that their study was one of the first “to assess the perceptions of patients with melanoma of the use of new digital technologies in surveillance for recurrent or new primary melanomas.”
The study was supported by a grant from the Australian National Health and Medical Research Council (NHMRC). One author reported receiving salary support from an Australian NHMRC fellowship; another received fellowships from the NHMRC and Cancer Institute New South Wales. Another author received scholarships and awards from the University of Sydney and the Sydney Catalyst Translational Cancer Research Centre.
SOURCE: Dieng M et al. JAMA Dermatol. 2019 May 15. doi: 10.1001/jamadermatol.2019.0434.
Elderly patients with a history of localized melanoma recognized the importance of skin self-examination (SSE), but expressed low confidence in their abilities to do it correctly, based on results of a small study. While many were willing to use teledermoscopy to assist them in self-exams, patients still preferred to rely on regularly scheduled exams by physicians.
“Low confidence in SSE is a key barrier to patient-led surveillance and to the use of digital technologies for SSE,” wrote Mbathio Dieng, PhD, of the University of Sydney and her coauthors in a study published in JAMA Dermatology.
The Australian researchers conducted semistructured interviews with 37 patients from Sydney. Patients’ median age was 67 years; 26 of 37 (70%) were men.
Barriers to SSE included a perceived lack of competence in self-exams; the patients said they doubted they would catch anything that needed to be caught.
As for digitally supported SSE, many patients expressed a willingness to consider tools that would assist in the self-assessment process. Several said they valued the additional reassurance between clinical visits and the ability to create their own action plan.
The authors acknowledged that they only recruited from a single tertiary center so the results are limited. However, in terms of steps forward, they noted that their study was one of the first “to assess the perceptions of patients with melanoma of the use of new digital technologies in surveillance for recurrent or new primary melanomas.”
The study was supported by a grant from the Australian National Health and Medical Research Council (NHMRC). One author reported receiving salary support from an Australian NHMRC fellowship; another received fellowships from the NHMRC and Cancer Institute New South Wales. Another author received scholarships and awards from the University of Sydney and the Sydney Catalyst Translational Cancer Research Centre.
SOURCE: Dieng M et al. JAMA Dermatol. 2019 May 15. doi: 10.1001/jamadermatol.2019.0434.
FROM JAMA DERMATOLOGY
New JIA, JIA-associated uveitis guidelines address knowledge gaps
while attempting to address gaps in the clinical screening, monitoring, and treatment of these diseases.
The first guideline – which was published simultaneously in Arthritis Care & Research and Arthritis & Rheumatology – offered 39 recommendations for treating children and adolescents with JIA and nonsystemic polyarthritis, sacroiliitis, and enthesitis. Due to the low quality of the supporting evidence, 31 of the recommendations were labeled as conditional.
“While these recommendations are intended to address common clinical situations, all treatment decisions must be individualized, with consideration of the unique aspects of each patient’s presentation, medical history, and preferences,” wrote first author Sarah Ringold, MD, of Seattle Children’s Hospital and her coauthors.
These recommendations serve as updates to an initial set on JIA treatment in 2011 and a 2013 addition on the treatment of systemic arthritis. In addition, the ACR has since adopted the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to generate its recommendations, which was described in an interview with Dr. Ringold as providing “greater transparency around the decisions made during the recommendation development process.”
“An important difference from the 2011 guidelines is that is that initial NSAID monotherapy is no longer recommended for children with polyarthritis, given the established benefits of early initiation of DMARD [disease-modifying antirheumatic drug] therapy for these patients,” she added. “In addition, these guidelines also support inactive disease as a treatment goal for children with polyarthritis, with treatment escalation recommended for patients with low disease activity.”
As general recommendations for patients with JIA and polyarthritis, the coauthors strongly recommend using triamcinolone hexacetonide over triamcinolone acetonide for intraarticular glucocorticoid injections, along with using infliximab in combination with a DMARD. Despite the quality of the supporting evidence being very low, they also strongly recommend against adding chronic low-dose glucocorticoids to treatment because of well-known adverse effects like growth suppression, weight gain, osteopenia, and cataract.
Other strong recommendations include choosing treatment with an NSAID in children and adolescents with JIA and active sacroiliitis; adding a tumor necrosis factor inhibitor (TNFi) rather than continued NSAID monotherapy and avoiding methotrexate monotherapy in children and adolescents with active sacroiliitis despite NSAIDs; and choosing NSAID treatment in children and adolescents with JIA and active enthesitis.
Recommendations on JIA with associated uveitis
The second guideline – also published in Arthritis Care & Research and Arthritis & Rheumatology – focused on the screening, monitoring, and treatment of JIA with associated uveitis. Their 19 recommendations serve as updates to 2006 recommendations from the American Academy of Pediatrics on routine ophthalmic screening in children with arthritis and 2012 recommendations from the German Uveitis in Childhood Study Group on proposed ophthalmic screening schedules, neither of which addressed the monitoring of children with an established diagnosis of uveitis or the treatment of uveitis.
“Although the quality of evidence was very low, and most recommendations were therefore conditional, this guideline fills an important clinical gap in the care of children with JIA-associated uveitis and may be updated as better evidence becomes available,” wrote first author Sheila T. Angeles-Han, MD, of the Cincinnati Children’s Hospital Medical Center and her coauthors.
Their strong recommendations include ophthalmic monitoring at least every 3 months in children and adolescents with JIA and controlled uveitis on stable therapy; monitoring within 1 month after each change of topical glucocorticoids in patients who are tapering or discontinuing that treatment; and monitoring within 2 months of changing systemic therapy for patients who are tapering or discontinuing that treatment.
They also strongly recommend education on the warning signs of acute anterior uveitis for children and adolescents with spondyloarthritis, along with tapering topical glucocorticoids before systemic therapy in children and adolescents with JIA and chronic anterior uveitis who are still on 1-2 drops a day of glucocorticoids.
“Our biggest message is that it is critical that uveitis is controlled, since persistent active uveitis can lead to sight-threatening complications and permanent vision loss,” Dr. Angeles-Han said in an interview. “It is important that ocular inflammation is controlled early, exposure to long-term topical glucocorticoids is limited, and that systemic treatment is started promptly.
“We also emphasize that close communication and collaboration between pediatric rheumatologists and ophthalmologists is important to ensure optimal vision outcomes,” she added.
These guidelines also factored in feedback from a patient and parent panel, particularly in regard to recommendations with a low level of supporting evidence.
“This partnership highlighted the importance of incorporating parent and patient preferences into treatment decisions and the need for shared decision-making approaches,” Dr. Ringold said.
Both guidelines were supported by the American College of Rheumatology and the Arthritis Foundation. Several authors reported support from the National Institutes of Health, the Rheumatology Research Foundation, and the Fundación Bechara. Several authors also reported receiving consulting and speaking fees, along with research grants, from numerous pharmaceutical companies.
SOURCES: Ringold S et al. Arthritis Care Res. 2019 Apr 25. doi: 10.1002/acr.23870 ; Angeles-Han ST et al. Arthritis Care Res. 2019 Apr 25. doi: 10.1002/acr.23871 .
while attempting to address gaps in the clinical screening, monitoring, and treatment of these diseases.
The first guideline – which was published simultaneously in Arthritis Care & Research and Arthritis & Rheumatology – offered 39 recommendations for treating children and adolescents with JIA and nonsystemic polyarthritis, sacroiliitis, and enthesitis. Due to the low quality of the supporting evidence, 31 of the recommendations were labeled as conditional.
“While these recommendations are intended to address common clinical situations, all treatment decisions must be individualized, with consideration of the unique aspects of each patient’s presentation, medical history, and preferences,” wrote first author Sarah Ringold, MD, of Seattle Children’s Hospital and her coauthors.
These recommendations serve as updates to an initial set on JIA treatment in 2011 and a 2013 addition on the treatment of systemic arthritis. In addition, the ACR has since adopted the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to generate its recommendations, which was described in an interview with Dr. Ringold as providing “greater transparency around the decisions made during the recommendation development process.”
“An important difference from the 2011 guidelines is that is that initial NSAID monotherapy is no longer recommended for children with polyarthritis, given the established benefits of early initiation of DMARD [disease-modifying antirheumatic drug] therapy for these patients,” she added. “In addition, these guidelines also support inactive disease as a treatment goal for children with polyarthritis, with treatment escalation recommended for patients with low disease activity.”
As general recommendations for patients with JIA and polyarthritis, the coauthors strongly recommend using triamcinolone hexacetonide over triamcinolone acetonide for intraarticular glucocorticoid injections, along with using infliximab in combination with a DMARD. Despite the quality of the supporting evidence being very low, they also strongly recommend against adding chronic low-dose glucocorticoids to treatment because of well-known adverse effects like growth suppression, weight gain, osteopenia, and cataract.
Other strong recommendations include choosing treatment with an NSAID in children and adolescents with JIA and active sacroiliitis; adding a tumor necrosis factor inhibitor (TNFi) rather than continued NSAID monotherapy and avoiding methotrexate monotherapy in children and adolescents with active sacroiliitis despite NSAIDs; and choosing NSAID treatment in children and adolescents with JIA and active enthesitis.
Recommendations on JIA with associated uveitis
The second guideline – also published in Arthritis Care & Research and Arthritis & Rheumatology – focused on the screening, monitoring, and treatment of JIA with associated uveitis. Their 19 recommendations serve as updates to 2006 recommendations from the American Academy of Pediatrics on routine ophthalmic screening in children with arthritis and 2012 recommendations from the German Uveitis in Childhood Study Group on proposed ophthalmic screening schedules, neither of which addressed the monitoring of children with an established diagnosis of uveitis or the treatment of uveitis.
“Although the quality of evidence was very low, and most recommendations were therefore conditional, this guideline fills an important clinical gap in the care of children with JIA-associated uveitis and may be updated as better evidence becomes available,” wrote first author Sheila T. Angeles-Han, MD, of the Cincinnati Children’s Hospital Medical Center and her coauthors.
Their strong recommendations include ophthalmic monitoring at least every 3 months in children and adolescents with JIA and controlled uveitis on stable therapy; monitoring within 1 month after each change of topical glucocorticoids in patients who are tapering or discontinuing that treatment; and monitoring within 2 months of changing systemic therapy for patients who are tapering or discontinuing that treatment.
They also strongly recommend education on the warning signs of acute anterior uveitis for children and adolescents with spondyloarthritis, along with tapering topical glucocorticoids before systemic therapy in children and adolescents with JIA and chronic anterior uveitis who are still on 1-2 drops a day of glucocorticoids.
“Our biggest message is that it is critical that uveitis is controlled, since persistent active uveitis can lead to sight-threatening complications and permanent vision loss,” Dr. Angeles-Han said in an interview. “It is important that ocular inflammation is controlled early, exposure to long-term topical glucocorticoids is limited, and that systemic treatment is started promptly.
“We also emphasize that close communication and collaboration between pediatric rheumatologists and ophthalmologists is important to ensure optimal vision outcomes,” she added.
These guidelines also factored in feedback from a patient and parent panel, particularly in regard to recommendations with a low level of supporting evidence.
“This partnership highlighted the importance of incorporating parent and patient preferences into treatment decisions and the need for shared decision-making approaches,” Dr. Ringold said.
Both guidelines were supported by the American College of Rheumatology and the Arthritis Foundation. Several authors reported support from the National Institutes of Health, the Rheumatology Research Foundation, and the Fundación Bechara. Several authors also reported receiving consulting and speaking fees, along with research grants, from numerous pharmaceutical companies.
SOURCES: Ringold S et al. Arthritis Care Res. 2019 Apr 25. doi: 10.1002/acr.23870 ; Angeles-Han ST et al. Arthritis Care Res. 2019 Apr 25. doi: 10.1002/acr.23871 .
while attempting to address gaps in the clinical screening, monitoring, and treatment of these diseases.
The first guideline – which was published simultaneously in Arthritis Care & Research and Arthritis & Rheumatology – offered 39 recommendations for treating children and adolescents with JIA and nonsystemic polyarthritis, sacroiliitis, and enthesitis. Due to the low quality of the supporting evidence, 31 of the recommendations were labeled as conditional.
“While these recommendations are intended to address common clinical situations, all treatment decisions must be individualized, with consideration of the unique aspects of each patient’s presentation, medical history, and preferences,” wrote first author Sarah Ringold, MD, of Seattle Children’s Hospital and her coauthors.
These recommendations serve as updates to an initial set on JIA treatment in 2011 and a 2013 addition on the treatment of systemic arthritis. In addition, the ACR has since adopted the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to generate its recommendations, which was described in an interview with Dr. Ringold as providing “greater transparency around the decisions made during the recommendation development process.”
“An important difference from the 2011 guidelines is that is that initial NSAID monotherapy is no longer recommended for children with polyarthritis, given the established benefits of early initiation of DMARD [disease-modifying antirheumatic drug] therapy for these patients,” she added. “In addition, these guidelines also support inactive disease as a treatment goal for children with polyarthritis, with treatment escalation recommended for patients with low disease activity.”
As general recommendations for patients with JIA and polyarthritis, the coauthors strongly recommend using triamcinolone hexacetonide over triamcinolone acetonide for intraarticular glucocorticoid injections, along with using infliximab in combination with a DMARD. Despite the quality of the supporting evidence being very low, they also strongly recommend against adding chronic low-dose glucocorticoids to treatment because of well-known adverse effects like growth suppression, weight gain, osteopenia, and cataract.
Other strong recommendations include choosing treatment with an NSAID in children and adolescents with JIA and active sacroiliitis; adding a tumor necrosis factor inhibitor (TNFi) rather than continued NSAID monotherapy and avoiding methotrexate monotherapy in children and adolescents with active sacroiliitis despite NSAIDs; and choosing NSAID treatment in children and adolescents with JIA and active enthesitis.
Recommendations on JIA with associated uveitis
The second guideline – also published in Arthritis Care & Research and Arthritis & Rheumatology – focused on the screening, monitoring, and treatment of JIA with associated uveitis. Their 19 recommendations serve as updates to 2006 recommendations from the American Academy of Pediatrics on routine ophthalmic screening in children with arthritis and 2012 recommendations from the German Uveitis in Childhood Study Group on proposed ophthalmic screening schedules, neither of which addressed the monitoring of children with an established diagnosis of uveitis or the treatment of uveitis.
“Although the quality of evidence was very low, and most recommendations were therefore conditional, this guideline fills an important clinical gap in the care of children with JIA-associated uveitis and may be updated as better evidence becomes available,” wrote first author Sheila T. Angeles-Han, MD, of the Cincinnati Children’s Hospital Medical Center and her coauthors.
Their strong recommendations include ophthalmic monitoring at least every 3 months in children and adolescents with JIA and controlled uveitis on stable therapy; monitoring within 1 month after each change of topical glucocorticoids in patients who are tapering or discontinuing that treatment; and monitoring within 2 months of changing systemic therapy for patients who are tapering or discontinuing that treatment.
They also strongly recommend education on the warning signs of acute anterior uveitis for children and adolescents with spondyloarthritis, along with tapering topical glucocorticoids before systemic therapy in children and adolescents with JIA and chronic anterior uveitis who are still on 1-2 drops a day of glucocorticoids.
“Our biggest message is that it is critical that uveitis is controlled, since persistent active uveitis can lead to sight-threatening complications and permanent vision loss,” Dr. Angeles-Han said in an interview. “It is important that ocular inflammation is controlled early, exposure to long-term topical glucocorticoids is limited, and that systemic treatment is started promptly.
“We also emphasize that close communication and collaboration between pediatric rheumatologists and ophthalmologists is important to ensure optimal vision outcomes,” she added.
These guidelines also factored in feedback from a patient and parent panel, particularly in regard to recommendations with a low level of supporting evidence.
“This partnership highlighted the importance of incorporating parent and patient preferences into treatment decisions and the need for shared decision-making approaches,” Dr. Ringold said.
Both guidelines were supported by the American College of Rheumatology and the Arthritis Foundation. Several authors reported support from the National Institutes of Health, the Rheumatology Research Foundation, and the Fundación Bechara. Several authors also reported receiving consulting and speaking fees, along with research grants, from numerous pharmaceutical companies.
SOURCES: Ringold S et al. Arthritis Care Res. 2019 Apr 25. doi: 10.1002/acr.23870 ; Angeles-Han ST et al. Arthritis Care Res. 2019 Apr 25. doi: 10.1002/acr.23871 .
FROM ARTHRITIS CARE & RESEARCH