AASLD Policy on Development and Use of Practice Guidelines, Guidances, And Position Papers

Introduction

The American Association for the Study of Liver Diseases (AASLD) recognizes the need to develop practice guidelines for liver diseases and is committed to supporting the process through an established Practice Guidelines Committee.  AASLD develops practice guidelines and practice guidances which represent the official opinion of the Association.

AASLD guidelines deal with common problem areas for health care practitioners who care for patients with liver disease.  These areas will include conditions (diseases, signs and symptoms) and technologies (diagnostic tests and therapeutic procedures). 

AASLD practice guidelines use clinically relevant questions, which are then answered by systematic reviews of the literature and followed by data-supported recommendations. The guidelines are developed by a multidisciplinary panel of experts who rate the quality (level) of the evidence and the strength of each recommendation using the Grading of Recommendations Assessment, Development, and Evaluation system (“GRADE”) and adhere to the clinical practice guidelines standards developed by the Institute of Medicine.

AASLD also publishes guidances on aspects of a topic that lack sufficient data to perform systematic reviews. Practice guidances are based on a comprehensive review and analysis of relevant published data and put forward guidance statements to help clinicians understand and implement the most recent evidence.

Practice guidelines and guidances can serve many useful purposes, including the development of logical aids to clinicians, hospitals, public health agencies, and managed care organizations in providing the most up to date, effective care for their patients, while taking into consideration the responsibilities for controlling medical costs.  The published guideline or guidance should assist the physician in patient care decisions and hopefully improve clinical outcomes.

Practice guidelines and practice guidances should not be viewed as “standards of care” to be followed to the letter but should be designed to aid clinics and organizations in the care of patients with liver diseases, as well as be flexible enough to allow clinicians to use them to aid in the management of patients with specific liver diseases.  Practice guidelines and guidances have been and will continue to be used to define adequate or appropriate medical care.

In addition to the development of practice guidelines and practice guidances supported by scientific data, the AASLD Practice Guidelines Committee (PGC) is empowered to develop, review and recommend the endorsement of position papers on topics in important areas of liver disease that present the state of the art of current clinical practice. In the absence of the availability of scientific data, the position papers may be based on expert opinion.  Conversely, Guidelines or Guidances require evidence-based scientific data to form a Guideline Recommendation or Guidance Statement. A distinction will be made between guidelines, guidances and position papers.

Steps in Guideline and Guidance Development and Approval Process

Topic Selection

The Practice Guideline Committee (“PGC”) with input from Special Interest Groups, selects topics for guideline and guidance development and submit them for approval by the Governing Board.

Writing Group Formation

1. The PGC and Special Interest Group leaders nominate experts for writing groups. The nominees are notified of their nomination and are requested to indicate whether they are interested in contributing to the project, and to provide a personal statement, Curriculum Vitae (“CV”) and disclosure of conflict of interest.
2. The PGC Writing Group Selection Subcommittee reviews each nominee’s documents and recommends a writing group (comprised of a Chair or two Co-chairs and five to ten additional members).
3. The Ethics Committee reviews the proposed writing group’s disclosures for compliance with the AASLD Code for the Assessment and Management of Conflict of Interest.
4. The writing groups must include members who are affiliated with different academic institutions and represent the diversity of the AASLD membership.
5. The AASLD Governing Board approves the composition of the writing group.
6. Invitations are extended to the writing group members by the PGC Chair.
7. A PGC member is assigned to the writing group and attends meetings as a resource. This individual also serves as a primary reviewer for the guideline or guidance.
8. For Guidelines only: A project agreement is executed with the consulting methodologist who will serve as a member of the writing group and lead the project team for the systematic reviews of the literature.

Practice Guideline Development

Clinical Questions and Scope of Work

1. The consulting methodologist provides in-person training on the GRADE methodology for the PGC chairs and writing group and facilitates the creation of preliminary clinical questions (Population, Intervention, Comparator and Outcomes, or “PICO”) that will form the basis of the literature search to support the recommendations in the guideline.
2. The PGC and Governing Board approve the PICO questions which constitutes the scope of the guideline.
3. The writing group drafts the guideline text and recommendations, and the methodologist provides the level of evidence based on the systematic review using the GRADE rating table.
4. The writing group provides feedback regarding the need to downgrade or upgrade the rating based on publication bias, study size, etc.
5. The draft guideline is reviewed by the PGC and a primary reviewer compiles their comments and provides a written summary of high-level comments to the chairs of the writing group.

Systematic Review of the Literature

1. Conduct a GRADE approach training session with the writing group and develop clinical questions (Population, Intervention, Comparator, Outcomes (PICO)
2. The PGC and Governing Board approve the PICO questions which constitutes the scope of the guideline.
3. The Methodologist and supporting team conduct the literature search based on search terms and inclusion and exclusion criteria approved by the writing group and submits a report of findings for review by the writing group to ensure that major studies have not been omitted. The final report, including data extraction and evidence tables is presented to the writing group.
4. The de nova systematic review articles are drafted and are reviewed by the PGC.

Guideline Manuscript Development

1. The writing group members volunteer to write specific sections of the guideline and to draft the preliminary recommendations which are based on the systematic review (SR) of the literature analysis. The guideline may also include guidance statements which are supported by a separate review of the literature apart from the focused systematic review. Currently the guidance statements are not rated for level of evidence; however the AASLD will begin rating guidance statements for levels of evidence in 2023.
2. The methodologist provides the level of evidence from the SRs evidence tables and the writing group provides feedback regarding the need to downgrade or upgrade the rating based on publication bias, study size, etc.
3. Draft 1 of the guideline is reviewed by the primary reviewer and PGC. The primary reviewer compiles their comments and provides a written summary of high-level comments to the chairs of the writing group.
4. During a meeting, the primary reviewer goes over the Committee’s comments and the writing group chairs have an opportunity to seek clarification about the changes to be addressed in the next draft.
5. Draft 2 of the guideline is reviewed by the PGC to ensure that their comments have been addressed.
6. AASLD Practice Guidelines Open Comment

Prior to finalization, draft practice guideline recommendations and guidance statements will be available for open comment for a two-week period. Stakeholders with an interest in reviewing draft recommendations and guidance statements must contact AASLD to sign a confidentiality agreement and complete a disclosure of conflicts of interest form prior to receiving the document.

7. Open comments will be collated by staff and reviewed by the writing group chairs.  Any changes made as a result of the open comment process will be reviewed by the writing group prior to approval by the PGC. Draft 3 is reviewed by the PGC and signed off
8. Draft 3 is reviewed by the Governing Board and approved.
9. Draft 3 is copyedited and submitted to one of the AASLD journals for publication.

Practice Guidance Development

1. PGC chair and vice-chair, writing group co-chairs and primary reviewer meet to go over the written guidance development process.
2. The writing group co-chairs draft a preliminary scope of work based on the AASLD template.
3. The writing group co-chairs, primary reviewer, and the writing group meet to go over the guidance development process and finalize the scope of work and writing assignments by section.
4. The PGC approves the scope of work.
5. Each section is written by a lead author and assisted by a secondary author. Authors may work on more than one section.
6. The writing group agrees on the timeframe for reviewing the literature and conducts the literature search for their section.
   • A draft of each section with a bibliography is sent to the writing group chairs.
   • The writing group chairs create a combined document that is reviewed by all members of the writing group which evolves into Draft 1.
   • The bibliography is uploaded to the Endnote reference manager.
7. Draft 1 of the guidance is reviewed by a primary reviewer and the PGC. The primary reviewer compiles their comments and provides a written summary of high-level comments to the chairs of the writing group.
8. During a meeting, the primary reviewer goes over the Committee’s comments and the writing group chairs have an opportunity to seek clarification about the changes to be addressed in the next draft.
9. Draft 2 of the guideline is reviewed by the PGC to ensure that their comments have been addressed.
10. Document drafts may also be sent to appropriate external societies for input as part of an endorsement agreement or to individual experts at the discretion of the PGC.
11. Draft 3 is reviewed by the PGC and signed off.
12. Draft 3 is reviewed by the Governing Board and approved.
13. Draft 3 is copyedited and submitted to one of the AASLD journals for publication.

External Review Process

1. Draft 2 documents may also be sent to appropriate external societies for input as part of an endorsement agreement.
2. If needed, external reviews may be conducted by external reviewers at the discretion of the PGC. Up to 3 external reviewers are selected and their disclosures of conflict of interest are reviewed in accordance with the Code for the Assessment and Management of Conflicts of Interest.
3. Written comments from members (and external reviews, if applicable) are reviewed with the Chairs of the writing group (and designated member or members, if appropriate)
4. Publication in an AASLD-associated journal will take place without further peer review and the document will be acknowledged as having undergone peer validation and be the expressed position of AASLD. Existing guidelines, guidances and position papers should be reviewed every three years by the PGC or the writing group and updated as necessary.  
5. Existing guidelines, guidances and position papers should be revised and published in an AASLD journal every 5 years.

AASLD Policies and Procedures of the Practice Guidelines Committee 

Committee

The committee will be composed of one AASLD Governing Board Liaison to be assigned by the Governing Board, one Chair and Vice Chair to be appointed by the AASLD leadership for a term of 3 years, and 19 additional members each to serve a term of 3 years and 2 patient representatives.  A trainee member will be appointed for a one or two-year term, will be exempt from selection criteria listed below for regular and associate members and shall be in addition to the 19 other committee members. Terms are renewable at the discretion of the Governing Board. 

The Chair position will be filled by the Vice Chair who ascends to Chair-elect during the last year of the Chair’s term. This individual should have at least 1-year experience on the Committee prior to assuming Chair responsibility.  At the discretion of the President-elect, the outgoing Chair may be invited to stay on the committee for a transition period of as long as one year.

Appointments to the PGC will be made by AASLD leadership following standard AASLD procedures for the selection of committee members.  Appointment considerations for regular (non-trainee) members should include the seniority and expertise of the Committee candidate.  A candidate should have been an AASLD member for at least 5 years before being considered for a Committee position. Recognizing the policy setting and editorial nature of the Committee, the AASLD is best served by Committee membership that is acknowledged as experts in clinical hepatology and clinical study methodology.  Representation should also strive to include expertise in pediatrics, liver and transplantation surgery, pathology, and epidemiology.  Such expertise is considered valuable for broad review of the clinical topics before the Committee. 

Identification of Subjects for Practice Guidelines or Guidances

The Committee will be responsible for selecting the topics of the practice guidelines, practice guidances and position papers, with input from Special Interest Groups, and for inviting writing groups,

Writing Groups

Writing groups will consist of a Chair and Co-chair and 6 to 10 additional members, all selected by the Committee members and submitted to the Board for approval. Members may include representation from subspecialties other than hepatology if appropriate, and individuals with expertise in pediatrics will be included whenever possible. The invited writing groups are acknowledged experts in the clinical area to be pursued. These individuals will also be required to disclose potential conflicts of interest to the AASLD that will be reviewed as part of the writing group selection process.  A conflict of interest assessment will be performed according to policies and procedures established by the Ethics Committee in conjunction with the Governing Board of the AASLD.

The group's Chair and other members must be able to commit to a timeframe of guideline development set by the committee.  The Chair (and other member/members as appropriate) is expected to meet with the Committee when invited to revise the document and participate in committee conference calls as needed until the project is completed. A non-US Chair and/or member can be invited with the approval of the AASLD Governing Board.

The Chair and members may be reappointed for additional terms at the discretion of the Committee.  Writing group members may be removed at the discretion of the Guideline Committee based on their inability to meet the Timetable for Guideline Development.

Review of published AASLD Guidelines

Each guideline. guidance and position paper should be updated or rewritten and published every five years. Preparation will begin 3 years after the last publication, at which time the Committee members will determine whether the guideline, guidance or position paper should be completely rewritten, or simply updated. Additionally, guidelines, guidances, and position papers will be reviewed annually by the writing group members to determine the need for an unscheduled update.