Early Experience with An Opt-In Research Register - Scottish Health Research Register (SHARE): A Multi-Method Evaluation of Participant Recruitment Performance.

Abstract Background Recruiting participants to a clinical study is a resource-intensive process and has high rate of failure. The Scottish Health Research Register (SHARE) provides recruitment support service which helps researchers recruit participants by searching patients’ Electronic Health Records (EHRs). The current study aims to evaluate the performance of SHARE in participant recruitment. Methods Recruitment projects eligible for evaluation were those for clinical trials or observational studies and had finished before the end of 2019. From SHARE records, for each project we calculated 1) the fraction of the participants recruited through SHARE as a percentage of the number requested by researchers (percentage fulfilled), 2) the percentage of the potential candidates provided by SHARE to researchers that were actually recruited (percentage provided and recruited), 3) the percentage of the participants recruited through SHARE of all the potentially eligible candidates identified by searching registrants’ EHRs (percentage identified and recruited). Research teams of the eligible projects were invited to participate in an anonymised online survey. Two metrics were derived from research teams’ responses, including a) the fraction of the recruited over the study target number of participants (percentage fulfilled), and b) the percentage of the participants recruited through SHARE among the candidates received from SHARE (percentage provided and recruited). Results 44 projects were eligible for inclusion. Recruitment data for 24 projects were collected (20 excluded because of missingness or incompleteness). Survey invites were sent to all the eligible research teams and received 12 responses. Analysis of recruitment data shows the overall percentage fulfilled was 34.2% (interquartile 13.3% − 45.1%), the percentage provided and recruited 29.3% (interquartile 20.6% − 52.4%) and percentage identified and recruited 4.9% (interquartile 2.6% − 10.2%). Based on the data reported by researchers, percentage fulfilled was 31.7% (interquartile 5.8% − 59.6%) and percentage provided and recruited was 20.2% (interquartile 8.2% − 31.0%). Conclusions SHARE may be a valuable resource for recruiting participants for some clinical studies. Potential improvements are to expand the registrant base and to incorporate more data generated during patients’ different health care encounters into the candidate-searching step.