Patient and Family Engagement in Australian and New Zealand Adult Critical Care Trials

Rationale: Engaging patients and families in critical care research is recognized as best practice. The extent of engagement in critical care trials in Australia and New Zealand is unknown after introduction of national guidelines in 2016. Objectives: To assess the extent of patient and family engagement in adult critical care research studies endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG). Methods: Prospective studies endorsed between January 2017 and December 2023 or previously endorsed and still recruiting during this period were included. The study design included a two-stage process: 1) retrospective independent assessment of patient and family engagement in study protocols, progress reports, and manuscripts and 2) prospective self-reported survey of study principal investigators and project managers to understand priority of engagement, types of activities, barriers, and facilitators. Both stages assessed engagement using a modified version of an existing tool developed by the Canadian Critical Care Trials Group (CCCTG) Patient and Family Partnership Committee. The Guidance for Reporting Involvement of Patients and Public 2 tool was also used in stage 1. Results: Stage 1 was a retrospective analysis using the CCCTG and Guidance for Reporting Involvement of Patients and Public 2 tools. Of the 35 studies reviewed in stage 1, patient and family engagement was infrequently reported (reported in eight protocols submitted to ANZICS CTG for endorsement [8 of 35; 23%], reported in one trial progress report [1 of 34; 3%] and in one protocol publication [1 of 17; 6%], and not reported in the 10 primary trial publications [0 of 10; 0%]). Stage 2 involved survey responses using the CCCTG tool. Twenty-eight (80%) of 35 studies had at least one survey response. Respondents for 20 of these studies (20 of 28; 71%) reported undertaking some form of patient and family engagement. The most common facilitator of engagement was staff engagement experience (12 of 28; 43%), and lack of resources (12 of 28; 43%) was identified as a key barrier. Conclusions: This study identified low rates of reported patient and family engagement in clinical trial protocols and manuscripts via independent appraisal compared with a high self-reported rate of engagement activities among studies endorsed via the ANZICS CTG. This study highlighted the importance of adequate resourcing for engagement activities, including experienced personnel and funding.