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  • Clinical Practice Guideline Manual

    Introduction

    The American Academy of Family Physicians (AAFP) develops evidence-based clinical practice guidelines (CPGs) to support family physicians in delivering high-quality, patient-centered care. CPGs are systematically developed statements that include recommendations informed by a comprehensive review of the evidence and an assessment of the benefits and harms of available care options. Their purpose is to help clinicians and patients make informed decisions that improve health outcomes.

    This manual summarizes the AAFP’s processes for producing rigorous, transparent, and trustworthy clinical practice guidelines. AAFP guideline development follows best-practice standards established by the National Academies of Medicine (Clinical Practice Guidelines We Can Trust) and the Council of Medical Specialty Societies (CMSS), including the CMSS Principles for the Development of Specialty Society Clinical Guidelines and the CMSS Code for Interactions with Companies.

    Clinical practice guidelines should be developed using rigorous evidence-based methodology with the strength of evidence for each guideline explicitly stated.

    • Clinical practice guidelines should be feasible, measurable, and achievable.
    • Clinical performance measures may be developed from clinical practice guidelines and used in quality improvement initiatives. When these performance measures are incorporated into public reporting, accountability, or pay for performance programs, the strength of evidence and magnitude of benefit should be sufficient to justify the burden of implementation.
    • In the clinical setting, implementation of clinical practice guidelines should be prioritized to those that have the strongest supporting evidence, and the most impact on patient population morbidity and mortality.
    • Research should be conducted on how to effectively implement clinical practice guidelines, and the impact of their use as quality measures. 
    • Evidence-based CPGs are an essential component of patient-centered care and support family physicians in providing consistent, equitable, and effective care across diverse clinical settings. The AAFP is committed to ensuring that its guidelines remain methodologically sound, clinically relevant, and aligned with the needs of family physicians and the patients and communities they serve.

    I. Development of Evidence-based Clinical Practice Guidelines (CPGs)

    a. Definition 
    Clinical practice guidelines (CPGs) are statements that include recommendations intended to optimize patient care. They are informed by a systematic review of the evidence and an assessment of the benefits and harms of alternative care options. Rather than dictating a one-size-fits-all approach, CPGs evaluate the quality of scientific evidence and translate it into clinically useful recommendations that support shared decision-making between family physicians and their patients.

    b. Oversight 
    Development of AAFP CPGs is overseen by the Commission on Health of the Public and Science (CHPS), with final approval by the AAFP Board of Directors. CHPS collaborates with AAFP staff and organizational leadership to determine when a clinical topic warrants guideline development, an external systematic review nomination, or an update to existing recommendations. Topic selection reflects AAFP’s strategic priorities and alignment with areas of clinical significance for family physicians.

    c. Principles for Development 
    AAFP guideline development follows the best-practice standards established by:

    • The National Academies of Medicine (formerly Institute of Medicine): Clinical Practice Guidelines We Can Trust

    • The Council of Medical Specialty Societies (CMSS): Principles for the Development of Specialty Society Clinical Guidelines

    • CMSS Code for Interactions with Companies

    These standards guide the development process across its full lifecycle, including:

    • Establishing transparency

    • Managing conflicts of interest

    • Guideline development group composition 

    • Incorporation of systematic evidence reviews

    • Evidence foundations and rating the strength of recommendations

    • Articulation of recommendations

    • External review

    • Updating and maintenance of guidelines

    d. AAFP Standards and Approach 
    AAFP develops CPGs using rigorous, evidence-based methodology, with the strength of evidence explicitly stated for each recommendation. Guideline development emphasizes feasibility, actionability, and applicability to the family medicine setting.

    AAFP strives to ensure that recommendations:

    • Are supported by high-quality evidence demonstrating meaningful improvement in patient-oriented outcomes such as mortality, morbidity, symptoms, and quality of life.

    • Support the delivery of equitable, accessible, person-centered care, with attention to the applicability of evidence across diverse populations and clinical settings.

    • Are feasible for implementation in typical family medicine practices.

    • Are disseminated broadly, including through peer-reviewed journals and AAFP’s online platforms, to enhance accessibility and clinical impact.

    II. Joint Development of CPGs with External Organizations

    The AAFP supports the development of patient-centered, evidence-based clinical practice guidelines that focus on what care patients should receive rather than which clinician or specialty should provide it. When guidelines address questions of management, consultation, or referral, the AAFP emphasizes the importance of clearly defined clinical competencies rather than specialty designation.

    The AAFP may collaborate with other medical organizations to jointly develop a clinical practice guideline when doing so enhances methodological rigor, reduces duplication of effort, or promotes consistency across specialties. Joint development may be appropriate when: 

    • Multiple organizations share interest in the same clinical topic;

    • The topic has broad applicability across primary care and specialty care; 

    • A shared evidence review can improve efficiency or consistency; or

    • Multi-society guidance would better support clinicians and patients. 

    a. Memorandum of Understanding (MOU) 
    When entering a joint guideline development process, the AAFP establishes a Memorandum of Understanding (MOU) with collaborating organizations. The MOU outlines:

    • Roles and responsibilities of each organization; 

    • Expectations for evidence review, drafting, and recommendation formulation;

    • Decision-making processes, including how consensus will be reached; 

    • Requirements for conflict-of-interest disclosure and management;

    • Publication plans and dissemination agreements; 

    • Processes for final approval by each organization’s governing body.

    The MOU ensures transparency, rigor, and independence of judgment for all participating organizations throughout the guideline development process. 

    b. AAFP Representation and Participation 
    AAFP participation in jointly developed guidelines typically includes:

    • Family physician representation on the Guideline Development Group (GDG); 

    • Participation in the evidence review process, including nomination of key questions or patient-oriented outcomes;

    • Internal methodological review by individuals or groups designated by CHPS (e.g., Science Advisory Panel); 

    • Review and approval through CHPS and ultimately the AAFP Board of Directors.

    When appropriate, the AAFP also supports participation of patient or caregiver representatives, particularly in areas where shared decision-making is central to high-quality care. 

    c. Standards for Collaboration 
    Jointly developed guidelines must align with AAFP’s evidence standards and the principles set forth by the National Academies of Medicine and the Council of Medical Specialty Societies (CMSS). All participating organizations are expected to adhere to comparable standards for:

    • Evidence review and transparency; 

    • Conflict-of-interest management;

    • Rating of evidence and strength of recommendations; 

    • Public and stakeholder engagement;

    • Periodic review and updating of recommendations. 

    d. Endorsement and Publication 
    Once a jointly developed guideline has completed peer review and each organization’s internal approval processes, the AAFP Board of Directors reviews the guideline for approval. Collaborators may also independently review and endorse the guideline according to their organizational policies.

    Final publication follows the process agreed upon in the MOU and may include peer-reviewed journals, organizational websites, and other dissemination channels. 

    III.  Identification of a CPG Clinical Topic

    Clinical topics for new or updated AAFP clinical practice guidelines are identified through a collaborative process involving CHPS, AAFP staff, and organizational leadership. Topic selection reflects AAFP’s strategic priorities and alignment with areas of clinical significance for family physicians.

    When considering potential CPG topics, CHPS evaluates factors such as:

    • Relevance to family medicine and applicability across diverse practice settings;

    • The presence or absence of existing evidence-based guidelines appropriate for use by family physicians; 

    • The potential impact on patient outcomes, clinical practice, or health system performance;

    • Availability of a high-quality evidence report, or feasibility of initiating an external or internal systematic review;

    • Alignment with AAFP strategic priorities, including support for preventive care, chronic disease management, and equitable, person-centered care.

    When a topic meets these criteria, CHPS may recommend proceeding with guideline development, initiating a systematic review, or reaffirming or updating an existing guideline. Collaborating organizations may be contacted early in the process when joint development is appropriate 

    IV.  Systematic Evidence Review of CPG Clinical Topic (IOM Standard 4)

    AAFP clinical practice guidelines are based on systematic reviews of the best available evidence. In many cases, the AAFP collaborates with the Agency for Healthcare Research and Quality (AHRQ) through its Evidence-based Practice Center (EPC) program to obtain an independent, high-quality systematic review.a. AHRQ Evidence-Based Practice Center (EPC) Review 

     

    a. When appropriate, AAFP staff and CHPS collaborate to develop an AHRQ topic nomination. This includes clearly defined key questions, patient-oriented outcomes, and input from family physicians and subject-matter experts. 
     
    If AHRQ accepts the nomination, AAFP participates in the review process through:

     

    • Technical Expert Panel (TEP) participation;

    • Ongoing communication with AHRQ program staff and EPC researchers;

    • Reviewing draft evidence reports and providing feedback. 
      The final AHRQ evidence report serves as the foundation for guideline development.

    b. Use of the Evidence Report 
    Draft AHRQ evidence reports or interim findings from AAFP-conducted reviews may be used to begin guideline drafting. Final recommendations are developed once the full evidence review is complete.

    These reviews follow standards consistent with Finding What Works in Health Care: Standards for Systematic Reviews (National Academies of Medicine), including:

    • Collaboration with a medical librarian to develop and execute search strategies;

    • Prespecified inclusion and exclusion criteria;

    • Dual screening and data extraction;

    • Documented reasons for study exclusion;

    • Critical appraisal of study quality using established tools;

    • Transparent reporting of methods and findings. 

    V.  Development of CPG Panel 

    AAFP forms a Guideline Development Group (GDG) for each guideline project to ensure broad expertise, balance of perspectives, and adherence to evidence standards.

    a. Composition of the GDG 
    The GDG is composed of:

    • Family physicians, including at least one member of SCRP and, when appropriate, members with relevant clinical expertise;

    • Individuals with methodological expertise, such as those designated by CHPS (e.g., Science Advisory Panel members);

    • Representatives from collaborating organizations (when applicable); 

    • A patient or caregiver representative, patient advocate, or person with lived experience when appropriate and feasible.

    b. Selection and Approval 
    AAFP staff collaborate with CHPS and organizational leadership to identify GDG members. The GDG chair is selected by CHPS and approved by the AAFP Board of Directors.

    c. Disclosures and Conflicts of Interest 
    All potential GDG members must disclose financial and intellectual interests relevant to the guideline topic. Disclosures are reviewed before appointment to ensure compliance with AAFP conflict-of-interest standards (detailed in Section VI). Members update their disclosures throughout the development process.

    VI.  Conflict of Interest (COI) Policy and Process 

    A robust conflict-of-interest (COI) policy is essential to producing trustworthy, evidence-based clinical practice guidelines. The AAFP follows COI standards consistent with the National Academies of Medicine (NAM) and the Council of Medical Specialty Societies (CMSS). These standards help ensure that guideline recommendations represent independent clinical judgment focused on patient benefit.

    a. Principles 
    The AAFP aims to minimize both real and perceived conflicts of interest in guideline development. Key principles include:

    • The GDG chair (or co-chairs) must not have relevant financial or intellectual conflicts of interest.

    • Individuals with significant COIs should not constitute a majority of the GDG.

    • Funders and external partners must have no influence on evidence review, drafting, interpretation, or phrasing of recommendations. 

    • All COIs must be disclosed, reviewed, and managed throughout the guideline development process.

    • The GDG chair must remain free of conflicts for at least one year following publication of the guideline.

    b. Disclosure Requirements 
    Before appointment, all potential GDG members must disclose:

    • Financial relationships, including industry funding, consulting, expert testimony, stock ownership/options, speaker bureau involvement, or research funding;

    • Intellectual COIs, including authorship of key studies, public advocacy, leadership roles in relevant specialty societies, or strong, publicly stated positions related to the guideline topic;

    • Activities or interests held in the previous three years; 

    • Relevant relationships among immediate family members (e.g., spouse/partner).

    c. Review and Management 
    AAFP staff and the GDG chair review all disclosures prior to appointment. When a COI is identified, possible actions include:

    • Exclusion from GDG membership;

    • Restrictions from participating in discussion or voting on specific recommendations;

    • Additional oversight or documentation requirements. 

    GDG members must verbally update their COI status at each meeting and provide written updates if relevant changes occur.

    d. Divestment 
    Where feasible, GDG members are encouraged to divest from financial holdings or relationships that may be affected by guideline recommendations.

    e. Exceptions 
    In certain circumstances, subject-matter expertise may require including individuals with COIs (e.g., subspecialists whose clinical work inherently overlaps with the guideline topic). In these cases, their role may be limited, and additional mitigation steps may be applied to maintain integrity.

    VII.  Clinical Practice Guideline Panel Collaboration

    Effective collaboration is essential to timely and high-quality guideline development. AAFP staff and the GDG chair coordinate the guideline timeline, communication processes, and expectations for all GDG members.

    a. Timeline and Expectations 
    A preliminary development timeline is created at the first GDG meeting. While AAFP strives for adherence, timeline adjustments may be necessary based on evidence review progress or external factors. GDG expectations—including participation, writing responsibilities, and communication standards—are reviewed at the outset.

    b. Guideline Outline 
    The GDG collaborates with AAFP staff to develop an outline for the guideline, including:

    • Key clinical questions; 

    • Draft recommendation areas;

    • Planned text sections; 

    • Tables and shared decision-making resources;

    • Potential implementation tools or algorithms. 

    c. Meetings and Communication 
    Regular virtual meetings and calls are scheduled throughout development. When a member cannot attend, written comments may be submitted in advance and reviewed during the meeting. 
    Electronic communication (email, shared documents, project management tools) is used throughout the process, with clear expectations for response times and deadlines.

    d. Publication and Dissemination Planning 
    Early in development, the GDG and staff identify the intended publication venue(s) and prepare for dissemination activities. These may include journal submission, AAFP website publication, press releases, infographics, or other materials designed to support clinical use.

    VIII.  Review of Published Evidence Report 

    Once the systematic review is complete, the GDG reviews the evidence report to confirm its adequacy as a foundation for guideline development.

    If more than 12 months pass between publication of an evidence review and guideline drafting, an updated search is conducted in collaboration with AAFP’s medical librarian to ensure relevant new evidence is captured. The updated search:

    • Uses the same predefined criteria as the original review;

    • Documents search strategies and reasons for exclusions; 

    • Includes dual screening and appraisal of new studies.

    The GDG reviews the evidence report to:

    • Confirm the relevance and completeness of included studies;

    • Evaluate study quality; 

    • Identify gaps or limitations;

    • Begin formulating draft recommendations supported by the evidence.

    IX.  Grading Evidence and Strength of Recommendation 

    AAFP uses a modified GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework to evaluate evidence quality and determine the strength of recommendations.

    a. Quality of Evidence 
    AAFP uses four levels of evidence quality:

    • Level A — High Quality: Further research is very unlikely to change confidence in the estimate of effect. 

    • Level B — Moderate Quality: Further research may change the estimate and confidence in it.

    • Level C — Low Quality: Further research is likely to change the estimate and confidence. 

    • Level D — Very Low Quality: The estimate is highly uncertain.

    b. Strength of Recommendation 
    Strength of recommendation reflects the GDG’s confidence that benefits outweigh harms:

    • Strong recommendation: Supported by consistent, high-quality evidence showing clear net benefit in patient-oriented outcomes. Most patients would choose the recommended action. 

    • Weak recommendation: Evidence of benefit exists but may be lower quality, inconsistent, or sensitive to patient preferences.

    • Good practice points: Used sparingly for actions that represent standard care despite lack of direct evidence. 

    c. Upgrading and Downgrading Evidence 
    The GDG may upgrade or downgrade evidence based on risk of bias, inconsistency, directness, imprecision, publication bias, effect size, dose-response relationships, and confounding factors.

    X.  Writing the Guideline

    a. Scope 
    Each guideline clearly states its scope, including clinical intent, target populations, intended users, and care settings.

    b. Methodology 
    The guideline reports the methods used for the evidence review, search criteria, quality assessment, and GRADE determinations. Flow diagrams (e.g., PRISMA) may be included when applicable.

    c. Moving from Evidence to Recommendations 
    The GDG uses a structured process to move from evidence to recommendations, incorporating:

    • Evidence quality and strength;

    • Benefits and harms;

    • Patient values and preferences; 

    • Feasibility and equity considerations;

    • Differences of opinion among GDG members when applicable.

    d. Writing Assignments 
    Sections are drafted by GDG members with support from AAFP staff. The GDG chair oversees compilation and review of draft versions.

    e. Implementability 
    Recommendations should be specific, actionable, and feasible in family medicine settings. Implementation tools (e.g., algorithms, decision aids, checklists) may accompany the guideline.

    XI.  CPG Peer Review 

    AAFP guidelines undergo both internal and external peer review.

    a. Internal Review 
    Internal review is conducted by individuals or groups designated by CHPS (e.g., the Science Advisory Panel). Reviewers provide methodological and content feedback. All comments and responses are documented.

    b. External Review 
    Stakeholders—including collaborating organizations, subject-matter experts, and when appropriate, patient advocacy groups—participate in external review. Reviewer comments and AAFP responses are documented

    XII.  AAFP Approval Process 

    After revisions from peer review:

    • CHPS reviews and votes on the guideline;

    • Upon CHPS approval, a recommendation is forwarded to the AAFP Board of Directors;

    • The Board reviews, requests clarifications if needed, and if satisfied, approves the guideline for publication; 

    • Collaborating organizations may then proceed with their own endorsement processes.

    XIII.  Publication 

    a.    Peer-reviewed journal
    Upon completion, the AAFP submits its guidelines for publication in a peer-reviewed journal, as appropriate. The guideline manuscript undergoes independent editorial review, and a decision is made about publication. Due to the nature of journals, all supporting materials (such as tables with quality ratings of studies) may not be able to be published. All supporting materials that are relevant to the guideline that are not published will be made available on the AAFP website.

    b.    Copyright issues
    Copyright issues are negotiated with the publication journal with appropriate licensing agreements made to the AAFP.

    c.    AAFP website
    After publication, the guideline is placed on the AAFP website for easy accessibility. Supporting documents that were not published with the original guideline will be available on the AAFP website as well.

    XIV.  Dissemination

    a.    Dissemination/marketing plan

    AAFP staff coordinate dissemination, which may include:

    • Press releases or news items;

    • AAFP website placement;

    • CME or educational materials; 

    • Infographics or summaries;

    • Posting to international guideline repositories (e.g., G-I-N).

    XV.  Five-Year Update of CPG 

    a.    Determination by CHPS
    All guidelines developed by the AAFP are scheduled for a review five years after completion. However, literature pertaining to a guideline is monitored regularly, and if it is deemed necessary, a review can be initiated sooner. Whichever the case, when a guideline review is initiated, a preliminary search of the literature is completed and brought to the commission to determine if a new systematic review is necessary. If so, the topic will be nominated to AHRQ for a full systematic evidence update. If not, a decision whether to reaffirm the guideline for additional time not to exceed five years, or retire the guideline. The commission’s recommendation is then approved by the Board of Directors.

    XVI.  Endorsement of External Guidelines

    External clinical practice guidelines may be reviewed by the AAFP when requested by another organization, by an AAFP member, or when identified as highly applicable to family medicine. Guidelines selected for review are evaluated using established AAFP criteria and the AAFP Endorsement Review Form (Appendix A).

    a. Eligibility and Initial Review 
    AAFP staff first assess whether a guideline is relevant to family physicians and appropriate for endorsement review. Eligible guidelines must include clear recommendations, transparent methodology, and sufficient detail on evidence assessment.

    b. Reviewer Assignment and Evaluation 
    Members of CHPS, SCRP, and/or AAFP experts with relevant experience review the guideline using the AAFP’s established criteria (Appendix B). Reviewers independently assess:

    • Methodological rigor and transparency of the evidence review 

    • Quality of evidence and grading systems used

    • Clarity and actionability of recommendations 

    • Applicability to family medicine

    • Adequacy of conflict-of-interest management by the developing organization 

    Reviewers submit written comments and a recommendation.

    c. Synthesis and CHPS Action 
    AAFP staff compile reviewer comments and resolve major discrepancies with the reviewers as needed. A recommendation is then submitted to SCRP and CHPS for approval. CHPS determines the final recommendation forwarded to the Board or Board Chair.

    d. Possible Outcomes 
    Based on CHPS review, the AAFP may recommend:

    1. Endorse — The guideline fully meets AAFP criteria. 

    1. Affirmation of Value — The guideline does not meet all criteria for endorsement, or AAFP cannot endorse all recommendations, but the content is still useful for family physicians.

    1. Do Not Endorse — The guideline does not meet AAFP criteria. AAFP may also choose to remain silent. 

    e. Communication and Posting 
    AAFP staff notify the requesting organization of the decision. Only guidelines receiving Endorsement or Affirmation of Value are posted on the AAFP website with a summary and link to the full guideline.

    f. Ongoing Review 
    Endorsed guidelines and Affirmations of Value are reviewed every five years, or sooner if new evidence warrants an update, to determine whether endorsement should be reaffirmed, modified, or withdrawn.

    Contact information:

    For information about the AAFP Guideline Endorsement Form, please contact Michael Monroe, Senior Manager, Clinical and Health Policy at mmonroe@aafp.org.

    APPENDIX OF USEFUL RESOURCES