Frameworks to Guide Diagnostic Guidelines: An Example

Article type
Authors
Khawandi J1, Brignardello-Petersen R2, Falcone E3, Santesso N2, Azzam M1, Kawtharany H1, Schünemann H4, Wiercioch W2, Nieuwlaat R2, Mustafa R5
1Evidence-Based Practice and Impact Center, Department of Internal Medicine, University of Kansas Medical Center, Kansas City , KS, USA
2Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton , Ontario, Canada
3Center for Immunity, Inflammation and Infectious Diseases, Montreal Clinical Research Institute (IRCM) , Montreal, QC H2W 1R7, Canada; Department of Medicine, Université de Montréal, Montreal, QC H3T 1J4, Canada; Department of Microbiology, Infectious Diseases and Immunology, Université de Montréal, Montreal, QC H3T 1J4, Canada
4Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton , Ontario, Canada; Department of Biomedical Sciences, Humanitas University, Milan, Italy; Department of Medicine, McMaster University, Hamilton , ON, Canada
5Division of Nephrology and Hypertension, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, USA
Abstract
Background: Developing guidelines about tests/test strategies is believed to be more challenging than management guidelines especially when there is no data about the impact of testing on important outcomes or accuracy of the test in diagnosing the condition. In this study, we provide a framework used when developing diagnostic Post Covid-19 Condition (PCC) guidelines as a case example to address the challenge of conditions that do not have agreed-on diagnostic criteria.
Objective: This study aims to showcase the utilization of an analytic framework in determining the usefulness of tests to aid in developing recommendations about their use in people with suspected PCC.
Methods: A group of methodologists and guideline developers drafted an initial framework to highlight case scenarios that will favor ordering a test in people with suspected PCC. By an iterative process including public input through surveys and discussion with clinical, research and patient experts, the framework was developed. We are currently using the suggested format in the development of Canadian PCC diagnostic guideline.
Results: Figure 1. shows the framework suggested. The process of determining the utility of different tests as part of the diagnostic pathway for people suspected to have PCC starts by asking four main questions; The questions start by does the test: 1) increase/decrease suspicion of PCC, 2) increase/ decrease suspicion of comorbidities associated with PCC, 3) confirm/ rule out other diagnosis and 4) change the management. If the answer to all questions is no, then the decision may favor not using the test and the question that should be asked is “why is the test being done?”, whereas if one or more of the answers is yes, then it may be favorable to do the test.
Conclusion: The suggested framework will provide guidance to methodologists, guideline developers and clinicians when developing diagnostic guidelines for conditions that do not have clear diagnostic criteria. The framework will need to be further validated and tested on similar conditions.
Importance to Patients: Having a framework like the one suggested could eliminate unnecessary testing thus decreasing undesirable effects including burden to the patient and healthcare provider, and cost.