News & Analysis Medical News & Perspectives ......p1187
Clinical Trials Update .....................p1191
News From the CDC.......................p1193
Groups Aim for Trustworthy Clinical Practice Guidelines
Mammography No Benefit in Reducing Deaths From Breast Cancer
More Safety, Booster Seat Use Could Help Kids Survive Crashes
Estimate of New Chronic HCV Cases Lower Than Expected
Antibiotic Eardrops Best for Treating Otorrhea in Kids With Ear Tubes
Workplace Partnership Boosts Screening for Colorectal Cancer
World Leaders Push to Prepare for Global Threats
Testosterone Therapy Boosts MI Risk
news@JAMA: From JAMA’s Daily News Site
Excessive Sugar Puts Hearts in the Danger Zone
Health Agencies Update ...............p1192 Childhood Stroke Cause Identified Public-Private Groups Seek Drug Targets FDA Halts Sale of Certain Tobacco Products Cardiovascular Risks of Testosterone
Medical News & Perspectives
Groups Aim for Trustworthy Clinical Practice Guidelines Mike Mitka, MSJ
T
he federal National Guideline Clearinghouse, which makes available to physicians and the public thousands of clinical practice guidelines, is raising the bar for acceptance of such documents to improve their trustworthiness. Beginning June 1, the clearinghouse will use the definition of clinical practice guidelines developed by the Institute of Medicine (IOM), as stated in the institute’s 2011 report Clinical Practice Guidelines We Can Trust: “Clinical practice guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options” (http://tinyurl.com /3t9hj8t). The IOM definition came about as a result of the Medicare Improvements for Patients and Providers Act of 2008, in which Congress asked the IOM to investigate the best methods for developing clinical practice guidelines. The National Guideline Clearinghouse was created in the late 1990s by the Agency for Healthcare Research and Quality, in partnership with the American Medical Association and the American Association of Health Plans (now America’s Health Insurance Plans). The clearinghouse’s mission is to provide physicians and others interested in health care “an accessible mechanism for obtaining objective, detailed information or clinical practice guidelines and to further their dissemination, implementation, and use.” The clearinghouse now has more than
2500 guidelines available for reading online at http://www.guideline.gov. Although guidelines that have been already developed will be grandfathered in at the clearinghouse, new guidance will have to meet revised criteria, as follows: • The guideline contains recommendations intended to optimize patient care and assist physicians, other health care practitioners, and patients to make decisions about specific clinical circumstances.
• The guideline is produced under the auspices of a medical specialty association; relevant professional society; public or private organization; government agency at the federal, state, or local level; or health care organization or plan. • The guideline is based on a documented systematic review of evidence. • The guideline assesses the benefits and harms of recommended care and alternative care options.
The National Guideline Clearinghouse says that authors of clinical practice guidelines must provide documentation that a guideline is based on a systematic review of the evidence and an assessment of the benefits and harms of recommended and alternative care options.
jama.com
JAMA March 26, 2014 Volume 311, Number 12
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of Wisconsin Oshkosh User on 06/08/2015
1187
News & Analysis
• The full-text guideline is available in English to the public on request (for free or for a fee). • Theguidelinemusthavebeendeveloped,reviewed, or revised within the past 5 years. The clearinghouse also states that it will not exclude a guideline if a systematic review is conducted that identifies specific gaps in the evidence base for some of that guideline’s recommendations. The major changes from the older criteria are that documentation must be provided showing that a guideline is based on a systematic review of the evidence and an assessmentofthebenefitsandharmsoftherecommended and alternative care options. Mary P. Nix, MS, health scientist administrator with the National Guideline Clearinghouse, said the changes originated with a suggestion from the IOM. “Our editorial board thoughtweshouldfollowupwiththeIOMrecommendation that the National Guideline Clearinghouse revise its definition of a guidelineandchangeourinclusioncriteria,”saidNix. “Previouslywewantedsystematicreviews,but we didn’t specify it in our criteria, and now we will be actually stating it.” Introducing greater rigor into guideline creationappearstobeneeded,asstudiescontinue to show questionable practices by groups assembling such guidance. For ex-
ample, a recent article in Mayo Clinic Proceedings looking at 149 interventional medicine subspecialty guidelines found only 46% graded the quality of evidence and only 38% commentedonconflictsofinterest.Whenthe researchers looked at 3425 recommendations with graded evidence, 11% were supported by level A evidence (randomized controlled trials or meta-analyses), 42% by level B evidence (single randomized controlled trial or nonrandomized trials), and 48% by level C evidence (expert opinion or case study) (Feuerstein JD et al. Mayo Clin Proc. 2014; 89[1]:16-24). Joseph D. Feuerstein, MD, lead author of the Mayo study and a gastroenterology fellow at Beth Israel Deaconess Medical Center in Boston, said he appreciates that for some interventions, rigorous clinical trials may be unavailable to authors writing guidelines. “Our feeling is that guidelines should be restricted to areas where there is strong evidence,” Feuerstein said. “When strong evidence is not there, then maybe we really should have a separate document with a best practice statement saying we don’t have strong evidence, this is just expert opinion, and we can’t say this defines quality of care.” He said such a distinction is important because guidelines without rigorous evidence are not only used by physicians; they
can also be used by insurers, quality assessment organizations, and malpractice lawyers, who can misinterpret such recommendations as defining quality of care and mistakenly punish or reward physicians. Harold C. Sox, MD, emeritus professor of medicine at Dartmouth College’s Geisel School of Medicine, Hanover, New Hampshire, is working with others to bring more rigor to clinical practice guidelines. He has high praise for the IOM report and the efforts by the National Guideline Clearinghouse, but he thinks more can be done to eliminate “statements about the use of procedures that don’t meet a high standard for evidence.” Sox said he and Sheldon Greenfield, MD, chair of the IOM committee that issued the 2011 report and professor of medicine in the University of California, Irvine School of Medicine, are trying to develop methods for measuring a guideline’s adherence to standards. “So, just like Consumer Reports, you’ll have some guidelines with 2 stars, some with 3 stars, and some with 5, all based on their adherencescoretothehighstandards,”saidSox, who is also on JAMA’s editorial board. “We feel that if you have quality standards and publish adherence to those standards, the customers—people who use guidelines—will choose the ones with better adherence.”
Estimate of New Chronic HCV Cases Lower Than Expected Bridget M. Kuehn, MSJ
T
he number of US individuals living with chronic hepatitis C virus (HCV) infection is about 500 000 fewer than previously estimated, according to new findings from the US Centers and Disease Control and Prevention (CDC) (Denniston MM et al. Ann Intern Med. 2014;160[5]: 293300). But despite this large change in prevalence, the new estimate still finds a substantial population of individuals with chronic HCV in the United States. The CDC’s new estimate is based on HCV testing of individuals participating in the National Health and Nutrition Examination Survey (NHANES) between 2003 and 2010. Of the roughly 30 000 tested, 273 (about 1%) tested positive for chronic HCV infection. If extrapolated to the wider US population, this would suggest that there are 2.7 million US individuals currently living with 1188
HCV compared with the 3.2 million predicted based on NHANES data from 1999 to 2002. The reason for this apparent decrease is not clear, according to the authors. It may be a statistical glitch; the old estimate falls within the confidence interval for the analysis. Another possibility is that increased death rates (Ly KN et al. Ann Intern Med. 2012;156(4):271-278) among those with HCV over the past decade may have reduced the overall population living with the disorder, said Scott D. Holmberg, MD, MPH, chief of epidemiology and surveillance for viral hepatitis at CDC and one of the study's authors. It is unlikely to be the result of more successful treatment of HCV during the interval between the 2 estimates because only about half of HCV-infected individuals are ever tested, and many of those who are diag-
nosed with the infection never receive medical care for it, according to the authors. “Whether this decline in numbers of infected people is real or not, there are still millions of people infected with hepatitis C,” said Holmberg. “This emphasizes the urgency of getting people tested, into care, and treated.” Both the old and new estimates likely underestimate the total prevalence of chronic HCV infection in the United States. NHANES doesnotincludehomelessindividualsorthose in prison, who are known to have high rates of HCV infection. According to Holberg, these uncounted populations would likely raise the estimates by about 500 000. The US Food and Drug Administration has approved 4 new medications for HCV infection in the past 3 years, and more than a dozen new drugs are under devel-
JAMA March 26, 2014 Volume 311, Number 12
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of Wisconsin Oshkosh User on 06/08/2015
jama.com
Clinical Trials Update .....................p1191
News From the CDC.......................p1193
Groups Aim for Trustworthy Clinical Practice Guidelines
Mammography No Benefit in Reducing Deaths From Breast Cancer
More Safety, Booster Seat Use Could Help Kids Survive Crashes
Estimate of New Chronic HCV Cases Lower Than Expected
Antibiotic Eardrops Best for Treating Otorrhea in Kids With Ear Tubes
Workplace Partnership Boosts Screening for Colorectal Cancer
World Leaders Push to Prepare for Global Threats
Testosterone Therapy Boosts MI Risk
news@JAMA: From JAMA’s Daily News Site
Excessive Sugar Puts Hearts in the Danger Zone
Health Agencies Update ...............p1192 Childhood Stroke Cause Identified Public-Private Groups Seek Drug Targets FDA Halts Sale of Certain Tobacco Products Cardiovascular Risks of Testosterone
Medical News & Perspectives
Groups Aim for Trustworthy Clinical Practice Guidelines Mike Mitka, MSJ
T
he federal National Guideline Clearinghouse, which makes available to physicians and the public thousands of clinical practice guidelines, is raising the bar for acceptance of such documents to improve their trustworthiness. Beginning June 1, the clearinghouse will use the definition of clinical practice guidelines developed by the Institute of Medicine (IOM), as stated in the institute’s 2011 report Clinical Practice Guidelines We Can Trust: “Clinical practice guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options” (http://tinyurl.com /3t9hj8t). The IOM definition came about as a result of the Medicare Improvements for Patients and Providers Act of 2008, in which Congress asked the IOM to investigate the best methods for developing clinical practice guidelines. The National Guideline Clearinghouse was created in the late 1990s by the Agency for Healthcare Research and Quality, in partnership with the American Medical Association and the American Association of Health Plans (now America’s Health Insurance Plans). The clearinghouse’s mission is to provide physicians and others interested in health care “an accessible mechanism for obtaining objective, detailed information or clinical practice guidelines and to further their dissemination, implementation, and use.” The clearinghouse now has more than
2500 guidelines available for reading online at http://www.guideline.gov. Although guidelines that have been already developed will be grandfathered in at the clearinghouse, new guidance will have to meet revised criteria, as follows: • The guideline contains recommendations intended to optimize patient care and assist physicians, other health care practitioners, and patients to make decisions about specific clinical circumstances.
• The guideline is produced under the auspices of a medical specialty association; relevant professional society; public or private organization; government agency at the federal, state, or local level; or health care organization or plan. • The guideline is based on a documented systematic review of evidence. • The guideline assesses the benefits and harms of recommended care and alternative care options.
The National Guideline Clearinghouse says that authors of clinical practice guidelines must provide documentation that a guideline is based on a systematic review of the evidence and an assessment of the benefits and harms of recommended and alternative care options.
jama.com
JAMA March 26, 2014 Volume 311, Number 12
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of Wisconsin Oshkosh User on 06/08/2015
1187
News & Analysis
• The full-text guideline is available in English to the public on request (for free or for a fee). • Theguidelinemusthavebeendeveloped,reviewed, or revised within the past 5 years. The clearinghouse also states that it will not exclude a guideline if a systematic review is conducted that identifies specific gaps in the evidence base for some of that guideline’s recommendations. The major changes from the older criteria are that documentation must be provided showing that a guideline is based on a systematic review of the evidence and an assessmentofthebenefitsandharmsoftherecommended and alternative care options. Mary P. Nix, MS, health scientist administrator with the National Guideline Clearinghouse, said the changes originated with a suggestion from the IOM. “Our editorial board thoughtweshouldfollowupwiththeIOMrecommendation that the National Guideline Clearinghouse revise its definition of a guidelineandchangeourinclusioncriteria,”saidNix. “Previouslywewantedsystematicreviews,but we didn’t specify it in our criteria, and now we will be actually stating it.” Introducing greater rigor into guideline creationappearstobeneeded,asstudiescontinue to show questionable practices by groups assembling such guidance. For ex-
ample, a recent article in Mayo Clinic Proceedings looking at 149 interventional medicine subspecialty guidelines found only 46% graded the quality of evidence and only 38% commentedonconflictsofinterest.Whenthe researchers looked at 3425 recommendations with graded evidence, 11% were supported by level A evidence (randomized controlled trials or meta-analyses), 42% by level B evidence (single randomized controlled trial or nonrandomized trials), and 48% by level C evidence (expert opinion or case study) (Feuerstein JD et al. Mayo Clin Proc. 2014; 89[1]:16-24). Joseph D. Feuerstein, MD, lead author of the Mayo study and a gastroenterology fellow at Beth Israel Deaconess Medical Center in Boston, said he appreciates that for some interventions, rigorous clinical trials may be unavailable to authors writing guidelines. “Our feeling is that guidelines should be restricted to areas where there is strong evidence,” Feuerstein said. “When strong evidence is not there, then maybe we really should have a separate document with a best practice statement saying we don’t have strong evidence, this is just expert opinion, and we can’t say this defines quality of care.” He said such a distinction is important because guidelines without rigorous evidence are not only used by physicians; they
can also be used by insurers, quality assessment organizations, and malpractice lawyers, who can misinterpret such recommendations as defining quality of care and mistakenly punish or reward physicians. Harold C. Sox, MD, emeritus professor of medicine at Dartmouth College’s Geisel School of Medicine, Hanover, New Hampshire, is working with others to bring more rigor to clinical practice guidelines. He has high praise for the IOM report and the efforts by the National Guideline Clearinghouse, but he thinks more can be done to eliminate “statements about the use of procedures that don’t meet a high standard for evidence.” Sox said he and Sheldon Greenfield, MD, chair of the IOM committee that issued the 2011 report and professor of medicine in the University of California, Irvine School of Medicine, are trying to develop methods for measuring a guideline’s adherence to standards. “So, just like Consumer Reports, you’ll have some guidelines with 2 stars, some with 3 stars, and some with 5, all based on their adherencescoretothehighstandards,”saidSox, who is also on JAMA’s editorial board. “We feel that if you have quality standards and publish adherence to those standards, the customers—people who use guidelines—will choose the ones with better adherence.”
Estimate of New Chronic HCV Cases Lower Than Expected Bridget M. Kuehn, MSJ
T
he number of US individuals living with chronic hepatitis C virus (HCV) infection is about 500 000 fewer than previously estimated, according to new findings from the US Centers and Disease Control and Prevention (CDC) (Denniston MM et al. Ann Intern Med. 2014;160[5]: 293300). But despite this large change in prevalence, the new estimate still finds a substantial population of individuals with chronic HCV in the United States. The CDC’s new estimate is based on HCV testing of individuals participating in the National Health and Nutrition Examination Survey (NHANES) between 2003 and 2010. Of the roughly 30 000 tested, 273 (about 1%) tested positive for chronic HCV infection. If extrapolated to the wider US population, this would suggest that there are 2.7 million US individuals currently living with 1188
HCV compared with the 3.2 million predicted based on NHANES data from 1999 to 2002. The reason for this apparent decrease is not clear, according to the authors. It may be a statistical glitch; the old estimate falls within the confidence interval for the analysis. Another possibility is that increased death rates (Ly KN et al. Ann Intern Med. 2012;156(4):271-278) among those with HCV over the past decade may have reduced the overall population living with the disorder, said Scott D. Holmberg, MD, MPH, chief of epidemiology and surveillance for viral hepatitis at CDC and one of the study's authors. It is unlikely to be the result of more successful treatment of HCV during the interval between the 2 estimates because only about half of HCV-infected individuals are ever tested, and many of those who are diag-
nosed with the infection never receive medical care for it, according to the authors. “Whether this decline in numbers of infected people is real or not, there are still millions of people infected with hepatitis C,” said Holmberg. “This emphasizes the urgency of getting people tested, into care, and treated.” Both the old and new estimates likely underestimate the total prevalence of chronic HCV infection in the United States. NHANES doesnotincludehomelessindividualsorthose in prison, who are known to have high rates of HCV infection. According to Holberg, these uncounted populations would likely raise the estimates by about 500 000. The US Food and Drug Administration has approved 4 new medications for HCV infection in the past 3 years, and more than a dozen new drugs are under devel-
JAMA March 26, 2014 Volume 311, Number 12
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of Wisconsin Oshkosh User on 06/08/2015
jama.com
