AGA Guidelines Policies & Procedures

Process for Developing Guidelines

AGA practice guidelines are evidence-based and developed through a multi-stakeholder process using the GRADE system. The quality of the evidence is evaluated in a technical review which is written by clinical experts and a GRADE methodologist. The guideline is written by the Guideline Writing Panel based on the evidence as documented in the technical review. Clinical decision support tools and other quality products are developed to support guideline implementation and published along with the technical review and guideline.

Use the selector tool below to review the steps undertaken during the GRADE process for the development of AGA clinical practice guidelines.

December 2014

Step 1. Topic Identification

The AGA Institute Clinical Guidelines Committee (CGC), AGA Institute Council (council), governing board and AGA members identify topic(s) to be developed within the coming year. The governing board reviews and approves all guideline topics before they are commissioned.

A formal “Call for Topics” is made to AGA members in March of each year. This call for topics is published in AGA eDigest, and/or other AGA communications. Topics are also solicited from AGA and AGA Institute committees, council and task forces. Topics are collated and submitted to the council by May for review and ranking. Suggested topics are prioritized and ranked based on the following criteria: prevalence of disease; resource utilization; variation in care; other existing guidelines; new data/changes in diagnosis or treatment; potential for measure/quality development. The topic submission process requires the submitter to address these criteria (see Call for Topics form).

The CGC reviews the council’s rankings and recommends four for the governing board’s approval as soon as the board receives them. The full list of topics reviewed and ranked by the council will accompany the CGC’s recommendations.

Step 2. Determination of Focused Clinical Guideline Questions

The CGC develops focused questions for each topic with input from the relevant council sections. The governing board will review and approve all guideline focused questions before the panel starts working on the technical review.

The approved focused clinical questions will guide the development of PICO (population, intervention, comparison, outcome) questions. This process involves creating specific questions for which PICO tables are developed using available evidence to answer specific clinical questions. If well done systematic reviews are available, GRADE evidence profiles for each PICO are constructed based on these reviews. Outdated, but otherwise well done systematic reviews can often be updated as necessary without repeating the review from start to finish. If no systematic reviews can be identified, a rapid review process can be used to determine if enough evidence exists to address a particular question. If sufficient evidence exists, a systematic review narrowly focused on the PICO will be conducted to provide the data necessary to develop the evidence tables.

Step 3. Technical Review Author Selection

The CGC identifies and secures authors with input from the council chair(s).

The CGC generates an initial list of technical review authors for the council’s consideration. The CGC and the appropriate council sections identify two potential clinical expert author(s) and two external reviewers based on the topic and scope of the paper. The GRADE methodologist consultant is also an author. Authors are vetted by the AGA Institute Ethics Committee for potential conflicts of interest in accordance with AGA policy.

Step 4. Technical Review Writing

The technical review is based upon the evidence profiles for each of the PICO questions developed by the methodologist with input from the clinical expert authors. Under the leadership of the methodologist, the authors draft the technical review.

A contracted information specialist/librarian conducts a literature search based on the parameters set by the methodologists and content experts. The methodologist creates the GRADE evidence profiles for each PICO question with input from the content experts. The content experts and methodologist draft the technical review under the leadership of the methodologist.

The content experts also prepare questions and answers related to each technical review for AGA members to earn online CME credits.

In February 2015, the AGA Insittute Governing Board approved a guideline technical review template:

Download

 

Step 5. External Review Process

The draft technical review is sent to external reviewers for review and comment. The authors respond to external review comments.

With recommendations from CGC members, three external reviewers are invited to review and provide comments on the draft technical review. Reviewers consider how well the draft or sections thereof address specific questions, objectives and concerns related to the topic and scope of the guideline.

The authors review and respond to all external reviewers comments. For comments/recommendations that the authors do not accept, the authors will formulate a response justifying their position.

Step 6. Guideline Champion

A CGC member is appointed to champion each guideline, actively overseeing that the process stays on track. This champion also chairs the Guideline Writing Panel.

For each guideline topic, the committee chair appoints a CGC member as the guideline champion as soon as the Governing Board approves the topic. The responsibilities of the champion are to chair the writing panel, establish expectations and milestones, monitor progress, report back to the CGC chair and chair-elect, and draft the guideline. The champion should have no conflict of interest and should not practice or conduct research in the same area of expertise as the topic being developed.

Step 7. Guideline Writing Panel

A panel of three CGC members develops the clinical recommendations and assigns the strength of each clinical recommendation. The panel writes the guidelines based on the technical review.

The panel may also include invited ad hoc participants such as a patient advocate, non-GI specialists (surgeons, radiologists, pathologists) depending on the specific topic, and/or a health economist. The clinical expert technical review authors will not be members of the panel. However, on occasion they may be consulted to address evidentiary questions which exceed the clinical expertise of the methodologist. The final composition of the panel needs to be such that it ensures that input from all relevant stakeholders (including community practitioners) is included during guideline development.

Step 8. Guideline Writing Panel (Panel) Convenes

The panel convenes to develop clinical recommendations and assigns the strength of each clinical recommendation.

The panel holds teleconferences (as needed) and one face-­to-­face meeting to discuss the findings of the technical review with the methodologist and clinical expert authors. Materials, including the draft technical review and external reviewer comments, are provided to the panel prior to the meeting.

The methodologist presents the findings in the technical review to the panel during the face-to-face meeting. The panel will write the clinical recommendations related to each PICO question. It is the panel chair’s responsibility to create the initial draft of the guideline. The strength of each recommendation is explicitly rated applying the GRADE system.

The panel releases the ‘final draft for public comment’ clinical practice guideline.

Step 9. Public Comment Period

Each clinical practice guideline is released for a 30-day public comment period along with the technical review. The panel reviews and responds to comments within two weeks of the closing of the comment period.

The panel releases the ‘final draft for public comment’ clinical practice guideline for a 30-day online public comment period.

The governing board will be asked to review and provide feedback during the public comment period.

The panel reviews and responds to comments within two weeks of the closing of the comment period. Revisions to the draft guideline are at the discretion of the panel, but all comments must be considered and responses internally documented.

The panel produces the ‘final draft following public comments periods’ clinical practice guideline within 30 days of the closing of the comment period.

Step 10. Clinical Decision Support Tools

Clinical decision support tools and other quality products are developed to support guideline implementation.

The panel drafts clinical decision support tools in accordance with the ‘final draft following public comments periods’ clinical practice guideline.

Step 11. CGC Review and Approval

The final draft of the clinical practice guideline, technical review and clinical decision tools are submitted to the CGC. The guideline champion presents the documents to the full committee for review and approval. Revisions are made prior to submission to the governing board.

The guideline champion/panel chair will present the clinical practice guideline, technical review and clinical decision support tools to the full committee either via email, teleconference, or during a committee meeting for the CGC’s review and approval. The committee’s review is to focus on the clarity of presentation and to ensure the process was followed correctly; i.e., not changing content or recommendations.

Step 12. Governing Board Review and Approval

The governing board reviews and approves the practice recommendations, the corresponding technical review and clinical decision support tools for publication in Gastroenterology.

The governing board will provide an "up or down" vote for approval, with editorial review of the final product only for clarity of presentation and to ensure the guideline construction process has been correctly followed.

Step 13. Publication

The approved versions of the clinical practice guideline, technical review and clinical decision support tools are published in Gastroenterology. The clinical practice guidelines and clinical decision tools will be in print (and online) and the full technical review will be online only.

The AGA Institute will make the clinical practice guideline, technical review and clinical decision tools which have been approved by its governing board available to members ahead of publication. Once a guideline has been approved by the governing board it, the manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Once this process is complete and the paper has been reviewed by the authors, it will be placed under Articles in Press. This final version will then be indexed in PubMed ahead of print.  The technical review will be published in print form in Gastroenterology, subject to word count and table limits as specified by the Editor.  Any materials above and beyond this limit can appear on-line.

Teleconferences are scheduled as necessary between the chair of the CGC and the managing editor of Gastroenterology to support appropriate publication planning.


Process for Updating Clinical Guidelines

The Clinical Guidelines Committee reviews all existing guidelines annually and selects any guidelines that are determined to need an update. One committee member is assigned a guideline to review and answer four questions:

  1. Is the guideline relevant to modern GI practice?
  2. Is the guideline up to date? (Do the recommendations represent a current standard of care?)
  3. Does the guideline require a major or minor revision?
  4. Has another society recently published a guideline on the same topic that negates the need for an AGA update?

Any guideline that the committee decides is not up to date will be assigned to one of three actions, based on how rigorous of an update it requires:

  1. The original authors will be asked to write a brief update document addressing new evidence and its application to the original guideline. The document will be published in Gastroenterology.
  2. The original authors or a subcommittee formed of CGC members update the sections of the guideline that are determined to be out of date.
  3. The guideline is removed from AGA’s website and archived. The topic may be queued for development as a new topic in the next round of guidelines.

Process for Endorsing Non-AGA Guidelines

New guidelines developed by other societies are to be submitted to the Clinical Guidelines Committee. One or two committee members closely review the guideline. Each committee member is expected to read through the guideline and consider the methodology and the guideline’s adherence to the guidelines put forth by the IOM’s 2011 article, “Clinical Guidelines We Can Trust.” The member(s) then report back to the committee with recommendation for or against endorsement.

Under the member(s)’ advisement, the committee decides together whether to recommend endorsement to the AGA Governing Board. Following the review, the committee submits a recommendation to the Governing Board on whether or not to endorse the guideline, along with any suggestions (e.g., conduct a peer review).

In the event of a discordant recommendation offered by the CGC and the Governing Board, representatives of each group convene to discuss the reasoning behind the recommendations in an effort to resolve any differences in overall opinion about endorsement.