The importance of non-clinical information in updating living recommendations: a case study of the Australian living COVID-19 clinical guidelines.

BACKGROUND AND

OBJECTIVE

Living guidelines facilitate optimized 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 contextualizing information from nonclinical sources is equally important in maximizing 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 nonclinical sources.

STUDY DESIGN AND

SETTING

We retrospectively identified and extracted all nonclinical information updates (ie, updates to the guideline based on information other than direct primary studies, 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 (eg, recommendation, evidence-to-decision), source of change (eg, expert consensus, consumer input, and government/policy decision), and reason for change (eg, approval/supply of therapeutics, clarity around population). Additional information was collected for specific high-impact nonclinical evidence updates.

RESULTS

A total of 302 nonclinical changes were made to the guidelines across a 3-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 nonclinical 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 nonclinical information, to determine whether a living approach is appropriate.