Consumer engagement and patient reported outcomes in perioperative clinical trials in Australia: a systematic review.

Abstract

Consumer engagement in clinical research is increasingly being prioritized by major funders such as the Australian National Health and Medical Research Council. We performed a systematic literature search of the Cochrane library, Embase, CINAHL PubMed and Medline to identify randomized clinical trials in surgery with perioperative outcomes conducted in Australia. All publications underwent review and thematic analysis to identify levels of consumer engagement and the inclusion of patient-reported outcome measures (PROMS). From 5373 records, the full texts of 809 articles were retrieved, of which 41 clinical trials met the inclusion criteria. PROMS were identified in 63% of the trials as a primary or secondary outcome. Despite multiple available checklists and analysis tools, less than 2% of studies documented any consumer engagement apart from PROMS. There was very little consumer engagement in formulation, management, conduct and dissemination of the trial findings.