Amir Qaseem, MD, PhD, MHA; Timothy J. Wilt, MD, MPH; for the Clinical Guidelines Committee of the American College of Physicians *
Disclaimer: The authors of this article are responsible for its contents.
Financial Support: Financial support for the development of this manuscript comes exclusively from the ACP operating budget.
Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-3279. 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 Clinical Guidelines Committee 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, email@example.com.
Current Author Addresses: Dr. Qaseem: American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106.
Dr. Wilt: Minneapolis VA Medical Center, 1 Veterans Drive (111-0), Minneapolis, MN 55417.
Author Contributions: Conception and design: A. Qaseem, C.J. Crandall, R. McLean, R.A. Mustafa, S. Vijan.
Analysis and interpretation of the data: A. Qaseem, T.J. Wilt, M.A. Forciea, D. Kansagara.
Drafting of the article: A. Qaseem, M.A. Forciea.
Critical revision of the article for important intellectual content: A. Qaseem, T.J. Wilt, M.A. Forciea, D. Kansagara, C.J. Crandall, L. Hicks, J.S. Lin, R. McLean, R.A. Mustafa, J. Roa, J. Tufte, S. Vijan.
Final approval of the article: A. Qaseem, T.J. Wilt, M.A. Forciea, D. Kansagara, C.J. Crandall, N. Fitterman, L. Hicks, C. Horwitch, J.S. Lin, M. Maroto, R. McLean, R.A. Mustafa, J. Roa, J. Tufte, S. Vijan.
Statistical expertise: A. Qaseem.
Administrative, technical, or logistic support: A. Qaseem.
Collection and assembly of data: A. Qaseem.
One of the hallmarks of a trustworthy clinical guideline or guidance statement is a comprehensive process for disclosure of interests (DOI) and management of conflicts of interest (COIs). The American College of Physicians (ACP) Clinical Guidelines Committee (CGC) aims to disclose all health care–related interests and manage conflicts in a manner that is transparent, proportional, and consistent. Any person involved in the development of an ACP clinical guideline or guidance statement must disclose all financial and intellectual interests related to health care from the previous 3 years. Persons complete disclosures at the start of their participation and are required to update them over the course of their involvement with the CGC, including before each CGC meeting. A DOI-COI Review and Management Panel reviews the disclosures; flags potential conflicts; grades the COI as low-, moderate-, or high-level; and manages the person's participation accordingly. A high-level COI results in recusal from authorship, voting, and all committee discussions. Participants with a moderate-level COI are recused from authorship and voting for clinically relevant topics but may participate in all discussions. A low-level COI results in no role restrictions. All disclosures and COI management decisions are publicly reported.
DOI and management of COIs: process from the Clinical Guidelines Committee of the American College of Physicians.
COI = conflict of interest; DOI = disclosure of interests; IT = information technology.
Table. Key Terms and Definitions in the American College of Physicians Clinical Guidelines Committee Policy for DOI and Management of COIs
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Johns Hopkins Universtiy School of Medicine
August 21, 2019
Why exclude clinical trial investigators?
The main route for developing drugs to address unmet patient needs is via large scale clinical trials. Those require investigators with expertise in the subject and grants to fund the huge amount of work that is required in modern drug trials. Why punish such investigators by prohibiting them from fully participating in developing clinical guidelines on the topic in which they are the experts?
Qaseem A, Wilt TJ, for the Clinical Guidelines Committee of the American College of Physicians. Disclosure of Interests and Management of Conflicts of Interest in Clinical Guidelines and Guidance Statements: Methods From the Clinical Guidelines Committee of the American College of Physicians. Ann Intern Med. 2019;171:354–361. [Epub ahead of print 20 August 2019]. doi: 10.7326/M18-3279
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Published: Ann Intern Med. 2019;171(5):354-361.
Published at www.annals.org on 20 August 2019
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