TPT 3.10 A Scoping Review of Limitations and Barriers to Recruitment of Patients to Randomised Controlled Trials in Emergency General Surgery

Abstract Background Emergency general surgery (EGS) is a clinical context with low quality research leading to a lack of evidenced based practice and geographical variation. This scoping review aimed to understand barriers to the completion of randomised controlled trial (RCT) in the context of EGS. Methods A Pubmed library search, supplemented by screening of the top 5 medical and surgical journals, was undertaken. Inclusion criteria were RCTs involving patients presenting as an emergency with an acute intra-abdominal pathology. Data extraction was focused on the paper (paper title, journal, year of publication) and study details (number of patients approached, recruited and retained; number of centres; primary pathology). Reported barriers to study completion were extracted and summarised. Results 609 abstracts were screened and 79 papers were included. Most studies focused on appendicitis (n=39) and cholecystitis (n=11). Most RCTs were single centre, with only 16 having more than 5 sites. The median number of patients approached and recruited were 209 and 120, respectively. Barriers to study completion included i) time pressures, ii) concerns about informed consent (i.e. due to severity of illness or strong pain medication) and hospital system barriers (pharmacy opening times, lack of imaging available). Conclusion This review has identified barriers to the conduct of EGS RCTs, with significant numbers of patients declining participating and/or dropping out, compromising study quality. The EGS patient population therefore remains under-researched and underserved, with significant methodological work required to improve the evidence base.