The importance of non-clinical information in updating living recommendations: a case study of the Australian Living COVID-19 Clinical Guidelines

BACKGROUND: Living guidelines facilitate optimised patient care by providing up to date, evidence-based recommendations. Although a strong focus has been placed on the updating of living recommendations using clinical evidence from primary studies, the inclusion of contextualising information from non-clinical sources is equally important in maximising the applicability, appropriateness and implementability of living recommendations. We aimed to examine the range and impact of changes to the Australian Living COVID-19 Clinical Guidelines based on information from non-clinical sources. STUDY DESIGN AND SETTING: We retrospectively identified and extracted all non-clinical information updates (i.e. updates to the guideline based on information other than direct primary studies, e.g. approval or supply of therapeutics) to the COVID-19 guidelines. For each update, we recorded the location in the guideline where the change was made (e.g. recommendation, evidence-to-decision), source of change (e.g. expert consensus, consumer input, government/policy decision), and reason for change (e.g. approval/supply of therapeutics, clarity around population). Additional information was collected for specific high-impact non-clinical evidence updates. RESULTS: A total of 302 non-clinical changes were made to the guidelines across a three-year period. The majority of changes were made to the additional information underpinning recommendations (46%), text of the recommendation (26%) or patient preferences and values (18%), with the most prevalent source of change being expert consensus (50%). Several impactful changes were made in areas such as tocilizumab supply and in vitro evidence regarding reduced activity of monoclonal antibodies against SARS-CoV-2 Omicron subvariants. CONCLUSION: Our analysis highlights the significant quantity and diversity of information captured and incorporated within the COVID-19 clinical guidelines from non-clinical sources. Engagement with a broad range of interest holders across living guideline iterations is integral to acquiring this information and developers should consider a fourth key criterion, based on non-clinical information, to determine whether a living approach is appropriate.