Clinical Practice Guideline Manual

The American Academy of Pediatrics published this Evidence-Based Clinical Practice Guidelines Development and Implementation Manual to provide a framework for standardizing and streamlining the prioritization, development, and revision of AAP guidelines. The manual provides strategic direction for guideline authors and participants, as well as, informs internal and external groups about the AAP’s guideline prioritization, development, revision, dissemination, and implementation processes for benchmarking purposes.

The information below is intended for authors of CPGs, Epidemiologists, COQIPS' Executive Committee members including the Committee on Guideline Development (COGD), the Board Committee on Policy, members of Systematic Review, Implementation Scientists, Payors, and Electronic Health Records (EHR) Staff.

Introduction

The Institute of Medicine (IOM), now the National Academy of Medicine (NAM), defined a set of aspirational goals for guideline developers. According to Clinical Practice Guidelines We Can Trust, in order to be trustworthy:

1. Guidelines must be transparently developed.
2. Conflicts of interest must be disclosed and addressed.
3. Teams must be multidisciplinary and involve all major stakeholders.
4. Systematic review of the literature must be undertaken.
5. Recommendations must be clearly articulated.
6. Recommendations must be linked to their evidentiary foundations.
7. Guidance must be peer reviewed.
8. Systems must be in place to update recommendations when new knowledge arises.

American Academy of Pediatrics Policy Types

The AAP publishes a variety of policy types affirming a position or offering specific guidance or fact-based information, including: Clinical Practice Guidelines (CPGs) – evidence-based clinical guidance that is based on a comprehensive literature review and data analyses with formal rules of evidence in support of each recommendation made; Policy Statements – statements that advocate, direct, or detail a public health position of concern to the AAP; Technical Reports – reports that are developed based on a review of the literature and data analyses; and Clinical Reports – reports that guide pediatricians in the clinical setting by addressing best practices and state- of-the-art medicine. The primary difference between CPGs and other AAP policy types is that guidelines provide evidence-based clinical recommendations and undergo a systematic, rigorous organizational process approved by the Board of Directors. Because of differences in rigor, it is recommended that guidelines, policies, and reports be given titles and contain content that reflect their statement types (e.g., a policy statement should not refer to itself as a guideline). For the purposes of this manual, the focus is solely on CPGs.

Topic Solicitation, Prioritization, and Selection 

• Describes the overall process and methodology for the solicitation of CPG topics across the AAP, and their prioritization, selection, and final approval.

• Describes the roles of the Council on Quality Improvement and Patient Safety (COQIPS), COQIPS’ Committee on Guideline Development (COGD), the Agency for Healthcare Research and Quality (AHRQ), the Section on Epidemiology, Public Health, and Evidence (SOEPHE), and the AAP Board Policy Committee, Executive Committee, and Board of Directors in CPG topic selection.

CPG Subcommittee Selection and Conflicts of Interest

• Describes the selection, structure, and determination of CPG subcommittee members.

• Describes the selection, duties, qualifications, and responsibilities of the CPG subcommittee chair.

• Describes the identification, selection, qualifications, and responsibilities of the CPG subcommittee vice chair, methodologist/epidemiologist, Partnership for Policy Implementation (PPI) representative, implementation scientist, practicing general pediatricians, content experts (eg, subspecialists), family representative, Guideline Coach, and AAP staff.

• Describes Conflict of Interest (COI) policy and External Partnership/Collaborations Memorandum of Understanding (MOU) document structures.

Systematic Review and Evidence Aggregation

• Reviews the process of systematic review, evidence aggregation, and determination of evidence quality.

• Describes the role of AHRQ and AAP in to how the systematic review is conducted.

• Describes how IOM (now NAM) Standards for Systemic Reviews is used as part of systemic review process.

• Addresses publication biases and grey literature along with practical considerations when searching for evidence of pediatric topics.

• Describes the general outline of the literature review process.

Developing Clinical Recommendations

• Describes the structure and content of CPG recommendations.

• Discusses how ambiguous, vague, and underspecified language is addressed.

• Describes how levels of obligation, statements of fact, and verbiage such as “consider” are used.

• Describes how evidence quality and recommendation strengths are weighed and determined.

• Describes and defines the role of values (ie, benefit outweighs risks, harms, and costs).

• Describes the format and structure determination of the Key Action Statement Profile.

• Describes the process for mitigation of conflict and dissenting opinions.

Guideline Meeting Structure and Support for Guideline Deliverables

• Defines how the CPG subcommittee writes Key Action Statements (KASs).

• Describes the structure and support required for the development and publication of KASs.

• Reviews the process and timeline of manuscript development within the CPG subcommittee structure, along with its communication with AHRQ-EPC and the AAP.

• Describes authorship criteria using the International Committee of Medical Journal Editors recommendations.

Peer Review in Guideline Development Objectives

• Describes the aspects of Peer, Internal, and External Peer review in regard to guideline development and the associated process.

• Defines the role of SOEPHE, COQIPS, and the AAP Board with the review of adequacy of transparency of COI and translation from evidence to recommendations.

Ongoing Literature Surveillance and Guideline Updates

• Defines literature surveillance.

• Defines which questions and search strategies are used when starting literature surveillance.

• Describes the need, timeframe, process, and documentation of CPG time stamps and updates.

Implementation

• Reviews the overall CPG development process.

• Describes barriers associated with guideline adoption in various settings and the need to identify CPG end users and relevant stakeholders.

• Provides a checklist of potential areas for implementation planning.

• Defines trialability and its relation to CPG implementation and dissemination along with the role of the implementation scientist.

• Specifies deliverables for implementation scientists as they relate to implementation tools for various settings.