Research quality and dissemination of paediatric randomised controlled trials with and without patient and family engagement: systematic review.

Objectives: Authentic patient and family engagement in child health research is defined as researchers working in partnership with patients and families on all aspects of the research process, including refining the research question, tailoring the intervention, devising study procedures and disseminating study findings. While there is good evidence of a positive impact of patient engagement on the research process, on research teams and on patient partners, there are few empirical data on the impact of patient and family engagement on research quality and dissemination. We conducted a systematic review to compare research quality and dissemination metrics for paediatric randomised controlled trials (RCTs) that engaged patients and families in the research process with trials that did not.

Design: Systematic review using the Cochrane Highly Sensitive Search to identify RCTs.

Data Sources: Ovid MEDLINE from 1 January 2011 through to 31 December 2020.

Eligibility Criteria: We included RCTs involving children and youth (<18 years of age) published in (a peer-reviewed general medical journal).

Data Extraction And Synthesis: Trials were categorised as those engaging patients and families (PE+) and those that did not (PE-). A standardised review form was used to confirm trial eligibility and extract data on study characteristics. Two reviewers independently screened and sorted RCTs into PE+ and PE- groups, extracted data and assessed research quality using the modified Cochrane Risk of Bias Tool (based on seven methodological criteria). The dissemination of RCT findings was determined using measures of academic and non-academic citation collected from Web of Science and Scopus.

Results: From 2011 to 2020, published 45 RCTs involving children and youth. Only 10/45 RCTs (22%) reported engaging patients and families in the research process. Research quality for PE+ and PE- paediatric RCTs was similar; 4/10 (40%) of PE+ trials and 13/35 (37%) of PE- trials were rated as 'fair' or 'good' (p=1.00). Academic citation frequency per year was similar for PE+ trials and PE- trials: Web of Science (median 6.6 vs 7.1, respectively; p=0.84). Non-academic dissemination measures were generally higher among PE+ trials; for example, median PlumX Social Media score per year for PE+ trials was 46.6, compared with a median score of 7.6 for PE- trials (p=0.02).

Conclusions: Despite increasing interest in patient and family engagement in child health research, this review showed that few paediatric RCTs report patient engagement activity. Research quality was similar for trials engaging patients and families compared with those that did not. Patient and family engagement in the trial, however, was associated with higher metrics for social media attention, compared with trials with no engagement.