Contributed by Madelin Siedler, 2019/2020 U.S. GRADE Network Research Fellow
The development of a high-quality, evidence-based clinical guideline is no small feat. It requires significant time and effort from content experts, methodologists, and organizational staff and typically takes more than 1-2 years from start to finish.
Given the effort and hours that go into guideline development, it’s all too easy - and all too common - for the reporting of the development process of these guidelines to significantly undersell their quality. This is important, because published analyses assessing the quality of guidelines will likely only use what is reported or referenced in the text of the guideline. In other words, guidelines that do not adequately report on the methods they used to develop their recommendations will be under-appraised in the published literature – and this could lead to a gross underestimation of a guideline-developing organization’s work as a whole.
Quality and Reporting Standards: A Brief Review
Over the past decade, a number of standard sets, reporting checklists, and appraisal tools have been published to assist guideline developers in the reporting of their methods and to provide ways for researchers to assess the quality of these guidelines. These standards and methods of appraisal include but are not limited to:
- The Appraisal of Guidelines for Research and Evaluation (AGREE) II tool (2010)
- the National Academy of Medicine (formerly the Institute of Medicine [IOM]) Standards for Trustworthy Clinical Practice Guidelines (2011)
- the Guideline International Network (G-I-N) Key Components of High-Quality and Trustworthy Guidelines (2012)
- World Health Organization (WHO) Handbook for Guideline Development (2nd ed., 2014)
- Reporting Items for practice Guidelines in HealThcare (RIGHT) Statement (2017)
A guideline may be developed using the most water-tight, rigorous methods, but if these methods are not adequately described either in the text of the guideline or in a referenced external text, then an assessor will likely under-appraise the quality of a guideline. To ensure the most accurate appraisal of a guideline possible, guideline developers should consider the following helpful tips:
- Create a guideline template including boilerplate text that meets as much reporting criteria as possible, such as a general description of the systematic review and recommendations development processes; competing interest statements for all involved authors and guideline panel members; a description of the method used to assess certainty of evidence and grade the strength of recommendations; and a clear table at the beginning of the document listing all clinical questions and resulting recommendations.
- Maintain an up-to-date, in-depth description of the guideline development process on the website of the guideline-producing organization. Refer to this page specifically in the text of the guideline. This allows both guideline end-users and potential assessors to view the development process in depth without requiring too much space in the guideline document itself.
- When in doubt, refer it out. If there are supplemental texts to the guideline that include information related to the development process – such as an underlying systematic review or a list of authors’ conflict of interest disclosures – make sure these documents are clearly referenced in the guideline text and made easily accessible in the online version via hyperlinks.
- Don’t make assumptions. Even aspects of the development process that seem obvious, such as whether the guideline is externally reviewed, will likely not be included in a published quality assessment if it is not explicitly mentioned.
- Always be specific. Do not make the end-user of a guideline have to guess who the guideline is for, the clinical questions driving the guideline, or the appropriate scenarios in which to employ the recommendations. Utilizing the PICO (Population, Intervention, Comparison, Outcome) format to explicitly describe the clinical questions and resulting recommendations is a failsafe way to ensure your guideline is specific enough to be useful.