Amir Qaseem, MD, PhD, MHA; Devan Kansagara, MD, MCR; Jennifer S. Lin, MD, MCR; Reem A. Mustafa, MD, MPH, PhD; Timothy J. Wilt, MD, MPH; for the Clinical Guidelines Committee of the American College of Physicians *
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Financial Support: Financial support for the development of this paper comes exclusively from the ACP operating budget.
Disclosures: Authors have disclosed no conflicts of interest. Authors followed the policy regarding conflicts of interest described at www.annals.org/article.aspx?articleid=745942. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-3290. All financial and intellectual disclosures of interest were declared, and potential conflicts were discussed and managed. Dr. Iorio acquired a high-level conflict (industry-supported chair endowment) during the course of works development and upon disclosure was recused from further discussion, authorship, and final manuscript approval. A record of disclosures of interest and management of conflicts of interest is kept for each CGC meeting and conference call and can be viewed at www.acponline.org/clinical_information/guidelines/guidelines/conflicts_cgc.htm.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that her spouse has stock options/holdings with Targeted Diagnostics and Therapeutics. Darren B. Taichman, MD, PhD, Executive Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Catharine B. Stack, PhD, MS, Deputy Editor, Statistics, reports that she has stock holdings in Pfizer, Johnson & Johnson, and Colgate-Palmolive. Christina C. Wee, MD, MPH, Deputy Editor, reports employment with Beth Israel Deaconess Medical Center. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Yu-Xiao Yang, MD, MSCE, Deputy Editor, reports that he has no financial relationships or interest to disclose.
Corresponding Author: Amir Qaseem, MD, PhD, MHA, American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106; e-mail, firstname.lastname@example.org.
Current Author Addresses: Dr. Qaseem: 190 N. Independence Mall West, Philadelphia, PA 19106.
Dr. Kansagara: 3710 SW US Veterans Hospital Road, Portland, OR 97239.
Dr. Lin: 3800 North Interstate Avenue, Portland, OR 97227.
Dr. Mustafa: 3901 Rainbow Boulevard, MS3002, Kansas City, KS 66160.
Dr. Wilt: VA Medical Center 111-0, Minneapolis, MN 55417.
Author Contributions: Conception and design: A. Qaseem, D. Kansagara, R.A. Mustafa,
Analysis and interpretation of the data: A. Qaseem, D. Kansagara, R.A. Mustafa, T.J. Wilt.
Drafting of the article: A. Qaseem, D. Kansagara, T.J. Wilt.
Critical revision of the article for important intellectual content: A. Qaseem, D. Kansagara, J.S. Lin, R.A. Mustafa, T.J. Wilt.
Final approval of the article: A. Qaseem, D. Kansagara, J.S. Lin, R.A. Mustafa, T.J. Wilt.
Statistical expertise: A. Qaseem.
Administrative, technical, or logistic support: A. Qaseem, T.J. Wilt.
Collection and assembly of data: A. Qaseem, T.J. Wilt.
The American College of Physicians (ACP) was one of the first organizations in the United States to develop evidence-based clinical guidelines and has been developing guidelines since 1981. ACP's Clinical Guidelines Committee (CGC), in collaboration with staff from the Clinical Policy department, develops clinical guidelines and guidance statements and continues to refine and enhance its methodology. This article presents an update of the CGC's 2010 paper outlining policies, methods, and presentation format of ACP's clinical guidelines and guidance statements. Updated methods include more stringent policies about disclosure of interests and conflict management; inclusion of public perspective; full adoption of GRADE (Grading of Recommendations Assessment, Development and Evaluation) methods; more standardized reporting formats that consider value of care, patient comorbid conditions, patient values and preferences, and costs; and further clarification of guidance statement methods.
Table. Additions and Changes in the 2019 CGC Methods Paper Compared With the 2010 CGC Methods Paper
Overview of development and approval process for CGC clinical guidelines and guidance statements.
ACP = American College of Physicians; AGREE II = Appraisal of Guidelines for Research and Evaluation II; CGC = Clinical Guidelines Committee; PICO = population, interventions, comparators, and outcomes.
Grading the certainty of evidence and strength of recommendations for ACP clinical guidelines using GRADE.
ACP = American College of Physicians; GRADE = Grading of Recommendations Assessment, Development and Evaluation.
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Alain Braillon MD PhD
University hospital, Amiens, France
June 20, 2019
Qaseem and colleagues, on the behalf of the College being rightly concerned by the quality of clinical guidelines updated the guidance for their development.(1) This is most welcome as the evidence-based medicine motto has been on a very slippery slope for long, hijacked by vested interests: the increasing flow of guidelines is not only out of control but also associated with a decrease in relevance, quality and integrity as enduringly disclosed in the Journal.(2-4) First, pledges for more stringent policies about conflict management _financial or not_, full adoption of “Grading of Recommendations Assessment, Development and Evaluation” methods, consideration of patient comorbid conditions and values/preferences … have been blowing in the wind when considering theirs recurrence. No public organization for enforcing these most simple cornerstones. Worse, in July 2018 Trump administration and Congress shuttered the National Guideline Clearinghouse (a Federal database created in 1998 at the Agency for Healthcare Research and Quality) considered as the best repository of its kind in the world (4,000 clinical practice guidelines; 200,000 visitors per month).Second, confusing the aim and means is an original sin. Guidelines are only a mean to improve practice. Changing practices faces complex barriers, guidelines are scraps of paper if no comprehensive program (e.g. balanced scorecard) with funding for quality assurance. The state of practices must be assessed; targets to reach must be pre-defined with tools for to promote implementation which must be monitored. These should be mandatory prerequisites. A recent study showed that two-thirds of patients with cirrhosis were prescribed and delivered potentially unsafe drugs using databases nurtured from 1998 to 2015 by healthcare professionals changed into clerks. Why big databases are graveyards for archaeologists and can’t provide real time red flags? Third, the quest for guidelines may be nurturing the problem: would ideal guidelines be a so critical issue if robust randomized clinical trials with adequate comparator on relevant clinical outcomes in patients from the real life setting were conducted and open access data available? “Garbage in, garbage out” remains the motto. Gastroenterologists, worldwide, have been enduringly recommending “Patients with severe alcoholic hepatitis should be treated with corticosteroids if there are no contraindications for their use (Strong recommendation, moderate level of evidence)” However, results of 16 randomised clinical trials have been very contradictory and the Cochrane review found no evidence of a difference between glucocorticosteroids and placebo. This saga began in 1971. Could guidelines be window dressing for a broken system?Last, harms from guidelines must not be overlooked as the devastating consequences of the naïve advocacy for prone position against cod death in the 70’s. Guidelines should ban “expert opinion » unless there is an ongoing clinical trial to confirm it.1 Qaseem A, Kansagara D, Lin JS, Mustafa RA, Wilt TJ; Clinical Guidelines Committee of the American College of Physicians. The development of clinical guidelines and guidance statements by the Clinical Guidelines Committee of the American College of Physicians: Update of methods. Ann Intern Med 2019. Online Jun 11. doi: 10.7326/M18-32902 Greenfield S, Kaplan SH. When clinical practice guidelines collide: finding a way forward. Ann Intern Med 2017;167:677-678. 3 Schünemann HJ, Al-Ansary LA, Forland Fet al. Guidelines International Network: Principles for disclosure of interests and management of conflicts in guidelines. Ann Intern Med 2015;163:548-53.4 Qaseem A, Forland F, Macbeth F, Ollenschläger G, Phillips S, van der Wees P; Board of Trustees of the Guidelines International Network. Guidelines International Network: toward international standards for clinical practice guidelines. Ann Intern Med 2012;156:525-31.5 Ellrodt AG, Conner L, Riedinger M, Weingarten S. Measuring and improving physician compliance with clinical practice guidelines. A controlled interventional trial. Ann Intern Med 1995;122:277-82.
Qaseem A, Kansagara D, Lin JS, et al, for the Clinical Guidelines Committee of the American College of Physicians. The Development of Clinical Guidelines and Guidance Statements by the Clinical Guidelines Committee of the American College of Physicians: Update of Methods. Ann Intern Med. 2019;170:863–870. [Epub ahead of print 11 June 2019]. doi: https://doi.org/10.7326/M18-3290
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Published: Ann Intern Med. 2019;170(12):863-870.
Published at www.annals.org on 11 June 2019
Cancer Screening/Prevention, Guidelines, Healthcare Delivery and Policy, Hematology/Oncology, Hospital Medicine.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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