Evidence-Based Guideline Development Process

Panel Selection and Conflict of Interest: An Overview

Conflict of interest should be documented throughout development of a clinical practice guideline as a part of the explicit approach. Any conflicts of interest or incentives that may jeopardize the integrity of the guideline development process are also evaluated, documented, and reported at several intervals throughout the guideline development, including at nomination, final conference and all face-to-face meetings of the panel, and publication. A definition of what constitutes conflict of interest is defined in the ACCP Disclosure Statement.

ACCP Guideline Panel Executive Committee

Individuals nominated to the Guideline Panel Executive Committee must disclose any real or perceived conflicts of interest or incentives. Should the disclosure appear to introduce a bias, the HSP Committee and its Policy and Procedures Subcommittee shall be presented with the potentiality of the bias and make the final decision regarding serving on the panel. The following individuals constitute the Guideline Panel Executive Committee:

  1. Guideline Panel Chair/Co-Chairs
  2. Methodologist
  3. HSP Liaison
  4. Project Coordinator

Guideline Panel Chapter Editors and Writing Panels
Individuals nominated to the Guideline Panel Writing Committees or to serve as chapter editors must disclose any real or perceived conflicts of interest or incentives. Ideally, panels should be composed of experts with no real or perceived conflicts of interest or incentives relative to the specific guideline topic. However, there may be nominated experts with conflicts or incentives who can ensure, in writing, that these conflicts do not introduce any bias that can impair the integrity of the practice guideline. Those with conflicts that are identified as such by the HSP Policies and Procedures Subcommittee shall either be removed from the chapter or section at issue or the writing committees shall contain individuals with several competing conflicts so that a relative balance is attained. Panel members with a potential conflict of interest should recuse themselves from related discussions and voting.

Practice Guideline Reviewers
Appointed reviewers and those who vote on HSP guidelines, publications, or related products will adhere to the current ACCP disclosure policy, including disclosing any real or perceived conflicts of interest or incentives and recusing themselves from reviewing and voting on those topics for which they may have a conflict.

Technical Expert Panels (convened by evidence centers)
In instances where the ACCP does not directly review the evidence or contract with an evidence-based practice center for completion of the evidence review (eg, an AHRQ-funded review), it is the responsibility of the evidence center to ensure that any real or perceived conflicts of interest or incentives of members of the technical expert panel or evidence center staff does not interfere with the integrity of the project. The HSP Committee and the guideline panel should be informed of any unresolved conflicts of interest from those involved with conducting the literature review. When the ACCP directly contracts with an evidence-based practice center (EPC), the principle investigator and other members of the EPC team shall disclose all conflicts of interests, real or perceived, for review by the HSP Subcommittee on Policies and Procedures.

The Three Phases of Conflict of Interest Disclosure and Evaluation The HSP Committee disclosure process ensures that any potential conflict of interest is properly evaluated and resolved at various points during the development of a guideline. This process details the mechanisms in place at each evaluation phase and offers a step-by-step procedure to collect and evaluate disclosures and offer recommendations to resolve any conflict.

Phase 1: Initial disclosure at the time individuals are nominated for participation on guideline panels

  1. Nominated panelists complete and submit conflict of interest disclosures to the HSP Committee for review and appointment to a panel.

  2. The ACCP conflict of interest form is completed, as required in the ACCP conflict of interest policy statement.

  3. If no disclosure is provided, the nominee cannot participate on the guideline development panel.

  4. If the nominated panelist has nothing to disclose, the conflict of interest evaluation process ends.

  5. If a disclosure is provided, the conflict is evaluated first by the HSP Policies and Procedures Subcommittee, which makes a recommendation to the full HSP Committee.

  6. The conflict is evaluated using the framework of sample questions for evaluating and determining the correct mode of dealing with any disclosed conflicts of interest. The following results prevail:
    a. Option 1: The examination concludes the conflict of interest is unacceptable, and the nominated panelist is prohibited from participating on the guideline panel.
    b. Option 2: The examination concludes that participation on the guideline panel is permitted with the execution of recommended actions to preclude bias.
    c. Option 3: The examination concludes participation is permitted, as the conflict of interest disclosure is deemed not a possible source of bias.
    d. Option 4: The examination reaches no conclusion, and the HSP Committee presents the disclosed conflict of interest to the ACCP Conflict of Interest Committee, where a final recommendation is made.

Phase 2: Face-to-face meetings and full-panel conference calls

  1. Previous conflict of interest disclosure forms are returned to the panelists for their review and update.

  2. Conflict of interest disclosures are sent to the Guideline Panel Executive Committee for review.

  3. The ACCP Conflict of Interest Assessment Form is completed, as put forth by the ACCP Conflict of Interest Policy Statement.

  4. If the panelist has nothing to disclose, the conflict of interest evaluation process ends.

  5. If a disclosure is provided where the Guideline Panel Executive Committee requires further examination to draw a conclusion, the conflict is evaluated.

  6. The conflict is evaluated using the framework of sample questions for evaluating and determining the correct mode of dealing with any disclosed conflicts of interest. The following results prevail:
    a. Option 1: The examination concludes the conflict of interest is unacceptable, and the panelist is prohibited from further participation on the guideline panel.
    b. Option 2: The examination concludes that participation on the guideline panel is permitted with the execution of recommended actions to preclude bias. If this happens, the panel will be informed of the conflict, and the individual will be requested to recuse himself/herself from the discussions and votes on that topic.
    c. Option 3: The examination concludes participation is permitted, as the COI disclosure is deemed not a possible source of bias.
    d. Option 4: The examination reaches no conclusion, and the Guideline Panel Executive Committee presents the disclosed conflict of interest to the HSP Subcommittee on Policies and Procedures for further review. The HSP Committee will repeat step 5. Should the HSP Committee be unable to make a final recommendation, the conflict of interest will be presented to the ACCP Conflict of Interest Committee where a final recommendation is made and the evaluation process ends.

Phase 3: Final disclosure prior to publication

  1. Guideline panelists complete and submit new conflict of interest disclosure forms, which are collated and forwarded to the journal.

  2. The conflicts are published with the guidelines for each panelist (those without conflicts are listed as such)

  3. In the case of significant conflicts, an accompanying statement will be published that the conflict commenced after the work of the panelist was concluded or subsequent to the development of the guideline recommendations.

In addition to review of conflicts disclosed by panelists, the guideline reviewers must also be vetted through a similar process:

  1. Review by members of appropriate NetWorks, the Health and Science Policy Committee, and the ACCP Board of Regents
    Individuals designated to review HSP guidelines must adhere to the conflict of interest policy set forth above. This may include recusal from reviewing and voting processes if an individual’s conflict is deemed to be relevant to the topic by the HSP Subcommittee on Policies and Procedures. Further, reviewers are asked to examine guidelines for influence of bias.

  2. CHEST Journal Peer Review
    Individuals designated to review HSP guidelines on behalf of CHEST must adhere to the conflict of interest policy set forth by CHEST. All reviewers are asked to review the guideline for, among other criteria, influence of bias.

Guideline Ranking & Disclaimer

Rank
Definition
1 This guideline is new and represents the best available evidence at this time. It will be reviewed on an annual basis to determine if it remains current.
2 This guideline is reviewed on an annual basis and there have been new studies published since the guideline was developed. However, the Health and Science Policy (HSP) Committee determined that these studies are not sufficient to warrant changing the guideline at this time. The information contained in this guideline provides the user with the best evidence available at the time the guideline was published. Readers are encouraged to search the current literature as a supplement to using this guideline.
3 This guideline is reviewed on an annual basis. The HSP Committee determined that new studies have been published that warrant an update of the (fill in) chapter/section of this practice guideline. The HSP Committee also determined that the remainder of the chapters/sections does not require updating and these recommendations remain current.
4 This guideline is reviewed on an annual basis. The HSP Committee determined that new data are available that are sufficient to potentially change guideline recommendations and a full revision is warranted.
5 This guideline has been reviewed on an annual basis. The HSP Committee has decided it is outdated; however, it has been retained for historical and/or educational purposes. These guidelines should be used with caution for clinical decision-making purposes.

The evidence-based practice guidelines published by The American College of Chest Physicians (“ACCP”) incorporate data obtained from a comprehensive literature review of the most recent studies available at the time of publication. Guidelines are intended for general information only, are not medical advice, and do not replace professional medical care and physician advice, which always should be sought for any specific condition. Furthermore, guidelines may not be complete or accurate because new studies that may have become available late in the process of guideline development may not be incorporated into any particular guideline before it is disseminated. ACCP and its officers, regents, governors, executive committee, members and employees (the “ACCP Parties”) disclaim all liability for the accuracy or completeness of a guideline, and disclaim all warranties, express or implied. Guideline users always are urged to seek out newer information that might impact the diagnostic and treatment recommendations contained within a guideline. The ACCP Parties further disclaim all liability for any damages whatsoever (including, without limitation, direct, indirect, incidental, punitive, or consequential damages) arising out of the use, inability to use, or the results of use of a guideline, any references used in a guideline, or the materials, information, or procedures contained in a guideline, based on any legal theory whatsoever and whether or not there was advice of the possibility of such damages.