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Clinical Guidelines
20 August 2019

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 PhysiciansFREE

Publication: Annals of Internal Medicine
Volume 171, Number 5

Abstract

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.
A rigorous process for disclosure of interests (DOI) and management of conflicts of interest (COIs) is essential for the development of high-quality clinical guidelines and guidance statements. National and international organizations, such as the National Academy of Medicine (formerly the Institute of Medicine) (1, 2) and the Guidelines International Network (3), have called for adoption of high-quality standards for the development of trustworthy guidelines and stress the importance of managing COIs as a critical component.
The goal of this article is to describe the methods used for collecting DOI and managing COIs during the development of clinical guidelines and guidance statements by the Clinical Guidelines Committee (CGC) of the American College of Physicians (ACP). The CGC has developed a policy that conceptualizes DOI as distinct from identification and management of COIs. All participants disclose a broad range of interests before contributing to the work of the CGC, and a DOI-COI Review and Management Panel determines whether any interests constitute a conflict. The Figure summarizes the CGC's process for disclosing all health care–related interests, assessing them and identifying conflicts, and managing COIs. The Table provides an overview of key terms and definitions.
Figure. 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.
Figure. 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
Table. Key Terms and Definitions in the American College of Physicians Clinical Guidelines Committee Policy for DOI and Management of COIs

Policy Rationale and Key Principles

The CGC's goals for disclosing all health care–related interests and managing COIs are to mitigate any actual bias during clinical guideline development and to ensure credibility and public trust in ACP clinical guidelines by reducing the potential for perceived bias. Some subjectivity is inherent to the development of any guideline or guidance statement. Systematic reviewers make judgments when assessing the quality of studies, as do guideline developers when balancing benefits against harms and costs to make recommendations (6). The threat of COIs influencing these judgments warrants robust management to ensure fidelity to the evidence. Studies have reported that COIs are prevalent in the development of clinical guidelines (7–10), but they are not always disclosed or managed appropriately (11–15). These findings are concerning in light of evidence that COIs may influence guideline development (16–18). Beyond the threat of actual bias, the appearance or perception of bias can also harm the credibility of scientific work (19–22). In recent years, medical societies have received national attention and criticism for COIs, particularly with regard to clinical guidelines (23–25). The absence of trust may serve as a barrier to implementation and impede the ultimate goal of clinical guidelines, which is to improve patient care and outcomes.
The CGC's guiding principle for collection of DOI and management of COIs is to prioritize the interests of the patient over any competing or professional interests via an evidence-based assessment of the benefits, harms, and costs of an intervention (26). Under the assumption that not all external interests present equal levels of threat, the CGC developed a tiered scheme to assess interests and manage COIs. The policy is based on 3 core tenets:
Transparency: All participant disclosures and COI management decisions are freely accessible so that readers may independently assess them and make judgments.
Proportionality: Not all COIs carry equal risk, so the management strategy should intensify as the seriousness of the COI increases.
Consistency: The policy should be implemented impartially across all variables, including who is reporting the COI, who is managing it, and which factors are considered in grading it.

Disclosure of Interests

Who Reports DOI?

Any potential participant (defined in the Table) in work related to ACP clinical guidelines must complete and maintain updated disclosures. This includes CGC members, members of the CGC's public panel, persons involved in the supporting systematic reviews commissioned by ACP, ACP staff, and any other guest attending a CGC meeting or conference call. All participants must report any health care–related interests for themselves and their household members.
Occasionally, the CGC develops guidelines that are based on externally funded evidence reviews (for example, the Agency for Healthcare Research and Quality Evidence-based Practice Center Program or the Veterans Affairs Evidence Synthesis Program). The process for DOI and COIs for participants involved in these reviews follows the funding entity's policy and is not subject to the CGC's policy.

What Is the Time Frame for DOI?

The time frame for reporting any health care–related interests is the previous 3 years. Although guidance on an appropriate lookback period is limited, this time frame is in line with current practice (27, 28).

When Is DOI Collected?

Disclosure of interests is a continual process throughout the development of a clinical guideline. A continual process is imperative to ensuring accurate DOI and managing conflicts because interests change frequently over time. All prospective participants complete a DOI form before engaging in any CGC work. Subsequently, ACP staff prompt participants to review and update the previous DOI summary report at several times, including ahead of each in-person CGC meeting for CGC members, ACP staff, and any other guest attending the meeting (3 meetings per year); at least once per year for other participants who do not attend each meeting (consultants and members of the CGC's public panel); and 1 year after a CGC member's term ends.
Participants are required to inform ACP staff in a timely manner if there is a change in their health care–related interests, such as a change in employment or initiation of a new relationship.

What Disclosures Are Mandated?

Participants disclose all active and inactive financial and intellectual interests related to health care (see the Table for definitions). Some of the categories for reporting interests are not mutually exclusive; for example, a research grant is financial (payments are received) but also results in an intellectual conflict. Participants also disclose recent publications related to any clinical topics being discussed in an upcoming CGC meeting. Participants should err on the side of full disclosure if in doubt about whether an interest warrants reporting. Interests related to any of the following categories should be reported: 1) all employment (not just that related to health care); 2) research and consulting support related to health care, such as research support, speakers bureau participation, consulting or advisory roles, or expert opinion or testimony; 3) investments and proprietary interests related to health care, such as stocks, bonds, and securities; commercial business interests; and patents, trademarks, and copyrights (this does not include broadly diversified investments, such as mutual funds); 4) professional activities and intellectual interests related to health care, such as boards, workgroups, panels, committees through other medical societies or health care organizations, advocacy or lobbying activities, and public speaking; and 5) any other aspect of the participant's background or present interests that was not previously captured and might be perceived as affecting objectivity or independence.

What Disclosures Are Not Mandated?

The CGC's policy does not mandate disclosure of interests related primarily to personal matters or relationships outside the household. Such interests may include nonhousehold familial and personal relationships (extended family, friends, or professional colleagues or adversaries); political, religious, or ideological views; philanthropic donations; and personal or family health issues or experiences. Although we acknowledge that individual experiences and viewpoints are relevant and a likely source of bias, it is not practical to assess them consistently across participants because of privacy considerations and the burden of extensive reporting. Participants should use their judgment about which additional interests may be pertinent and might need to be disclosed, erring on the side of full disclosure.

How Are Interests Disclosed?

Studies have found discrepancies between open payment reporting systems and interests reported by clinical guideline authors (11, 12). Structured forms with closed-ended questions that are tailored to the topic area gather more complete information than generic forms with open-ended prompts (13, 29). Participants involved in the development of ACP guidelines disclose interests using a structured electronic format with specific categorical prompts. Participants sign and date the form after each review and update, certifying that to their knowledge and belief they have disclosed all financial and nonfinancial interests and will promptly disclose any changes.

Public Reporting

The DOI forms for committee members (authors and nonauthor contributors), staff, and any other participant, which are signed after each meeting, are publicly available on ACP's Web site. All ACP clinical guidelines and guidance statements contain a link to these reports.

Assessment of Interests and Identification of COIs

DOI-COI Review and Management Panel

The DOI-COI Review and Management Panel consists of the current CGC chair; the vice chair; and staff from the ACP Department of Clinical Policy, including the vice president of the department and associates. At least 2 associates independently review the DOI for potential conflicts and bring flagged interests to the DOI-COI Review and Management Panel for further discussion. The final management decision resides with the CGC chair, the vice chair, and the vice president. Members of the DOI-COI Review and Management Panel do not review their own DOI; the remainder of the panel determines the assessment. For example, at least 2 associates review the chair's disclosures, and the final management decision resides with the vice chair and the vice president.

Review Process

All prospective participants are screened for potential conflicts before initiating and engaging in any work related to clinical guidelines or guidance statements or attending CGC meetings. The DOI-COI Review and Management Panel reviews current disclosures for all participants to identify and assess COIs for the upcoming agenda before any CGC meeting or any time a participant reports a new DOI.

Levels of COIs

The CGC developed a 3-tiered grading scheme to assess the seriousness of a COI. The DOI-COI Review and Management Panel grades all potential conflicts as high-, moderate-, or low-level, using the definitions outlined in the following sections for guidance. This scheme is based on the assumption that organizations standing to profit directly from the clinical conclusions of a guideline present the most serious threat to the CGC's conclusions (30, 31) and reputation (19–22), and their inclusion adds no unique benefit. The CGC also considers intellectual and professional interests an important source of bias, but the potential benefit of including expert perspective balances the seriousness of the potential threat. The aim of managing conflicts related to organizations that stand to profit from guidelines is to insulate the development process fully from such influence, whereas the aim of managing conflicts related to intellectual and professional interests is to incorporate the perspective with checks and balances.

High-Level COIs

A high-level COI is any active relationship (financial or otherwise) with a high-risk entity, which the CGC defines as an entity that has a direct financial stake in the clinical conclusions of a guideline or guidance statement. High-risk entities include but are not limited to drug, biotechnology, medical device, and insurance companies, given that guidelines provide these industries with an opportunity to increase or protect profits by promoting products or services. Active relationships with most high-risk entities are high-level conflicts regardless of whether the interest is clinically relevant to the guideline topic (see the Table for the definition of clinical relevance). For many high-risk industry organizations, it is not feasible to assess their clinical relevance consistently over time due to a corporate landscape with frequent mergers, acquisitions, and pipeline additions and rapidly changing product portfolios (32, 33). Similarly, insurers' interests are relevant to a wide spectrum of diseases and care, making it difficult to link them to a single clinical area or disease.
Patient or disease advocacy organizations are also considered high-risk entities but are graded as high-level COIs only when their mission is clinically relevant to the topic under discussion. Although these organizations are typically nonprofit, their financial viability is explicitly linked to the promotion of screening, diagnostic, and treatment practices. Because they are built largely on fundraising, these groups are vulnerable to donor influence and have a considerable interest in public image, which at times may place them at odds with scientific objectivity (34). Furthermore, many patient advocacy organizations have significant financial ties to industry (35). Unlike drug and device companies, it is reasonable to assume that the relevance of these organizations is limited to a specific clinical condition and will remain bound to that area indefinitely.

Moderate-Level COIs

A moderate-level COI most frequently represents an intellectual interest that is clinically relevant to the guideline topic. Intellectual COIs are previously formed conclusions that may leave a clinical guideline vulnerable to cognitive biases and may result in indirect financial benefit related to career advancement (5). Although often unintentional or unconscious, several types of cognitive bias should be of particular concern to clinical guideline developers, including confirmation bias (the inclination to interpret or disregard new evidence in favor of validating existing beliefs or theories) and authority bias (the tendency to give greater weight or uncritical acceptance to the opinions of experts) (36, 37). Professional incentives, such as corroboration of publicly stated findings or conclusions, may reinforce such cognitive biases. Given that expertise may influence the conclusions of systematic reviews or clinical guidelines (38, 39), it is appropriate and necessary to document and assess intellectual interests in order to balance their influence and opinion (5). Moderate-level COIs may also signify the potential for an individual or entity to create professional advantages or financial profit based on an association with the development of a clinical guideline rather than its specific conclusions. For example, a health care startup developing clinical decision-making tools may seek to associate itself with clinical guideline developers in order to bolster its business and products.

Low-Level COIs

A low-level COI includes any inactive high-level COI (meaning the interest or relationship was terminated within the previous 3 years). This affords participants with high-level COIs an opportunity to become eligible for participation if they are willing and able to terminate relationships with high-risk entities and/or divest themselves of potential future profit. It also maintains transparency of the former interest to other participants and readers. Low-level COIs also include intellectual interests that only tangentially relate to the topic under discussion. An intellectual COI graded as low-level signals that a potential moderate-level COI was flagged and reviewed but the DOI-COI Review and Management Panel assessed the probable intellectual bias as minimal.

What Interests Do Not Constitute a Conflict?

Any work performed on behalf of ACP as either a staff member or an appointed representative is not considered a COI. Any interest that was released or terminated more than 3 years previously is not a COI. General employment with most nonprofit organizations (excluding disease advocacy) or other public interest entities that are not involved with paying for care is also not considered a COI.

Management of COIs

The CGC does not use the term “resolution” of COIs because this would imply that the risk is in the past and any regulating action is complete. Instead, the CGC manages COIs, meaning it continually acknowledges, assesses, and manages them over the course of clinical guideline development. The CGC's management policy assumes that disclosure by itself is inadequate to minimize bias (40, 41). If management begins and ends with disclosure, there is a risk for confusion because the audience may feel uncertain about how to interpret the conclusions in light of the disclosure (42). Without a clear policy or procedure, implementing conflict management can be disruptive to the work process and may result in participant stress that hinders compliance, such as discomfort with excluding or partially restricting participants from certain discussion or activities (43, 44).
The degree to which the DOI-COI Review and Management Panel manages COIs is proportional to their seriousness (Figure). The panel manages each participant on the basis of the highest assessed level of risk; for example, a participant who reports both moderate- and high-level conflicts is managed as high-level. A conflict management summary is included in the agenda materials ahead of each meeting or conference call and is orally presented by staff at the start of each meeting.

High-Level COIs

There are 2 options for management of a high-level COI. The first is that the participant releases the interest through divestment or by discontinuing the association if he or she is willing and able to do so (for example, a participant may sell off stock in a pharmaceutical company). Once inactive, high-level COIs are downgraded to low-level because the opportunity for direct financial benefit has been eliminated, and restrictions are removed from the participant. If a participant is unwilling or unable to release the interest, the second option is that he or she is restricted from further involvement in development of the clinical guideline. For CGC members, this includes participation in discussions, voting on recommendations, and authorship, or he or she may resign from the committee. Similarly, ACP staff, members of the CGC's public panel, and evidence review team members with high-level COIs may not participate in any discussion or authorship. Technical Expert Panel members for ACP-funded systematic reviews may have high-level COIs because these panels serve in a purely advisory capacity for the external evidence review team; however, the majority of the panel members must be free of high-level COIs.

Moderate-Level COIs

A participant with a moderate-level COI is partially restricted from participation when the COI is clinically relevant to the guideline or guidance statement. The participant is not eligible to serve as an author or vote on final approval but participates fully in committee deliberations. Some have argued that topic expertise is necessary to interpret evidence appropriately (45, 46). The CGC agrees that topic expertise is valuable to the development of clinical guidelines. As such, participants with moderate-level COIs participate and contribute their expertise in all discussions related to the clinical guideline, and CGC members with moderate-level COIs are acknowledged as nonauthor contributors in the final publication. For moderate-level intellectual conflicts, the “active” and “inactive” designations do not apply because an intellectual COI is less finite than a direct financial benefit (for example, a participant's bias toward his or her own research findings is not likely to end at conclusion of the study). Thus, any designation of an intellectual COI as moderate will carry forward through the remainder of the works development process, regardless of whether the interest becomes inactive or the guideline development extends beyond the 3-year reporting time frame.

Low-Level COIs

A participant with a low-level COI has no role restrictions and may participate in discussions, serve as an author, and vote on recommendations.

What COIs Are Not Managed?

The CGC considers several types of COIs as universal, for which it would not be feasible to apply a tiered management approach. The CGC acknowledges that all persons bring a distinct viewpoint and source of potential bias based on personal histories and relationships but, for reasons discussed previously, these disclosures are not mandated and hence not managed. The CGC also recognizes that physician incentives related to subspecialty, practice setting, and payment model are important sources of bias in the development of clinical guidelines. However, the CGC does not implement additional restrictions to manage these COIs because it is difficult to define consistent and appropriate thresholds to parse out and address the complex interactions among these considerations. Furthermore, all participants are welcome to self-regulate beyond the standard policy and recuse themselves from certain roles or discussions if they feel a personal or professional bias that could interfere with or be perceived as interfering with the deliberation process.

Public Reporting

All ACP clinical guidelines and guidance statements include a summary of management of COIs that lists conflicts and describes any role restrictions related to moderate- or high-level conflicts for committee members who participated in development of the guideline or guidance statement.

Implementation of the CGC's Policy for DOI and COIs

The CGC initially implemented this revised policy in September 2015 and approved it in May 2018 after piloting and refinement. The policy did not result in any impediments to the committee's workflow, and members were receptive to its implementation. Prescreening of disclosures from potential new committee members also allowed ACP to avoid inviting potential members whose high-level COIs would substantially hamper their participation in the committee's work.

Conclusion

The CGC developed a comprehensive policy to collect DOI and manage COIs in order to preserve its evidence-based framework and ensure public trust in its clinical guidelines. The CGC developed a standard DOI form and COI grading scale to regularly assess risk and determine appropriate management strategies for consistent implementation of the process. The intensity of the management strategy is proportional to the seriousness of the conflict because not all conflicts present an equal level of threat to the clinical guideline development process. Further, all DOI and COI management decisions are publicly available and freely accessible.

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Shmuel Shoham22 August 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?

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Information

Published In

cover image Annals of Internal Medicine
Annals of Internal Medicine
Volume 171Number 53 September 2019
Pages: 354 - 361

History

Published online: 20 August 2019
Published in issue: 3 September 2019

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Authors

Affiliations

Amir Qaseem, MD, PhD, MHA
American College of Physicians, Philadelphia, Pennsylvania (A.Q.)
Timothy J. Wilt, MD, MPH
Minneapolis VA Medical Center, Minneapolis, Minnesota (T.J.W.)
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 protected].
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.
This article was published at Annals.org on 20 August 2019.
* This paper, written by Amir Qaseem, MD, PhD, MHA, and Timothy J. Wilt, MD, MPH, was developed for the Clinical Guidelines Committee of the American College of Physicians. Individuals who served on the Clinical Guidelines Committee from initiation of the project until its approval were Timothy J. Wilt, MD, MPH† (Chair); Mary Ann Forciea, MD† (Immediate Past Chair); Devan Kansagara, MD, MCR† (Vice Chair); Carolyn J. Crandall, MD, MS†; Nick Fitterman, MD†; Lauri A. Hicks, DO†; Carrie A. Horwitch, MD, MPH†; Alfonso Iorio, MD, PhD‡; Jennifer S. Lin, MD, MCR†; Michael Maroto, JD, MBA†§; Robert M. McLean, MD†; Reem A. Mustafa, MD, PhD, MPH†; Jairo Roa, MD, MScEd†; Janice Tufte†§; and Sandeep Vijan, MD, MS†. Approved by the ACP Board of Regents on 3 November 2018.
† Author (participated in discussion and voting).
‡ Nonauthor contributor (partially participated in discussion but excluded from voting).
§ Nonclinician public representative.

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Amir Qaseem, Timothy J. Wilt, 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 20 August 2019]. doi:10.7326/M18-3279

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