Associate Professor THE HOSPITAL FOR SICK CHILDREN TORONTO, Ontario, Canada
Background: Patient and family engagement in child health research involves researchers working in partnership with patients and families during the research process, including refining the research question, tailoring the intervention, devising study procedures, and participating in the dissemination of study findings. While there is good evidence of a positive impact of patient engagement on the research process, little is known about the impact of patient and family engagement on research quality and dissemination. Objective: To compare pediatric randomized controlled trials (RCTs) that engaged patients and families in research with trials that did not, on research quality and dissemination. Design/Methods: We identified pediatric RCTs published in a peer-reviewed general medical journal (BMJ) from 2011 to 2020. We used an Ovid Medline search strategy to identify RCTs involving children and youth ( < 18 years of age). Trials were categorized as those engaging patients and families (PE+) and those that did not (PE-). We developed a standardized review form to confirm eligibility and extract data on study characteristics. Two reviewers screened and sorted all RCTs into the two groups, extracted data, and assessed research quality using the Cochrane Risk of Bias Tool (7 criteria). Dissemination of RCT findings was determined using measures of academic and non-academic citation. Results: From 2011 to 2020, The BMJ published 45 RCTs involving children and youth. Only 10/45 RCTs (22%) reported engaging patients and families. However, 7/10 trials published from 2015 onwards included a Patient and Public Involvement paragraph in the Methods section of the manuscript, subsequent to a requirement to report patient engagement by The BMJ. Research quality for PE+ and PE- paediatric RCTs was similar. The overall quality rating for RCTs was low. Around 60% of trials showed 1 of 7 criteria with a high risk of bias or 2 of 7 criteria with an unclear risk of bias. Citations/year was similar for PE+ trials compared with PE- trials (median(IQR): 6.8 (5.7–8.5) vs. 7.3 (4.4-13.5)); however, social media attention was higher in the PE+ group (median(IQR) Altmetric Attention Score: 29 (4–48) vs. 6 (1–20).
Conclusion(s): Despite increasing patient and family engagement in child health research, this study showed that few RCTs report any patient engagement activity. Research quality was similar for trials engaging patients and families in research 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.
