Development of an a-priori decision framework that weighs contextual factors to determine the acceptable certainty of evidence for clinical decision-making

Article type
Authors
Hemler R1, Heus P2, Hofstede S3, Hooft L2, Janssen F4
1Knowledge Institute of the Dutch Association of Medical Specialists, Utrecht, The Netherlands; Department of ENT, Gelre Hospital, Apeldoorn, The Netherlands
2Cochrane Netherlands, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
3Knowledge Institute of the Dutch Association of Medical Specialists, Utrecht, The Netherlands
4Knowledge Institute of the Dutch Association of Medical Specialists, Utrecht, The Netherlands; Cochrane Netherlands, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
Abstract
Background
In clinical guideline development, the certainty of evidence usually determines the strength of the recommendations. Yet, for many clinical questions, there is a (very) low certainty of evidence, often leading to weak guideline recommendations. Whether a clinical question demands a high certainty of evidence is context dependent. In situations with a (very) low certainty of evidence, other factors considered can still lead to the formulation of strong recommendations. To date, no framework exists to systematically map these contextual factors and assess a priori what (un)certainty of evidence is accepted for clinical decision-making.

Objective
To develop a framework that guideline panels can use to uniformly and transparently map contextual factors and a priori assess the accepted level of certainty of evidence for clinical decision-making

Methods
First, to identify existing concepts and constructs, we performed a scoping review and searched Embase, Ovid/MEDLINE, and Overton databases, followed by additional searches in Google Scholar and on websites of international institutions. In parallel, exploratory interviews with multiple relevant stakeholders (including a patient representative) were held to collect input from the field. The second phase consists of drafting a preliminary framework, followed by a Delphi procedure and further refinement. The resulting framework will be pilot-tested and evaluated by various guideline panels in phase 3, leading to the final framework.

Results
The database search for the scoping review yielded 2618 records. Searches in Google Scholar and on institutional websites will be performed from March to April 2024. Interviews are planned between March and May 2024. Based on the results from the scoping review and exploratory interviews, we will present an overview of contextual factors and a preliminary decision-framework.

Future prospects
This a priori decision framework will support guideline panels in formulating recommendations when taking into account the accepted (un)certainty of evidence for the specific clinical context, leading to more clarity for clinical practice. This is important, as patients should receive the best available care and situations should be avoided in which care is not provided because of a low certainty of evidence, while there are other factors proving the added value of this care.