Recruitment of patients into head and neck clinical trials: acceptability of studies to patients from perspective of the research team

• Published in: British journal of oral & maxillofacial surgery 2018-05, Vol.56 (4), p.278-282
• Main Authors: Ho, M.W., Pick, A.S., Sutton, D.N., Dyker, K., Cardale, K., Gilbert, K., Johnson, J., Quantrill, J., McCaul, J.A.
• Format: Article
• Language: English
• Subjects: Acceptability clinical trials; Clinical trials; Dentistry; Head and Neck Neoplasms - therapy; Head and Neck research; Humans; Observational Studies as Topic - methods; Observational Studies as Topic - standards; Observational Studies as Topic - statistics & numerical data; Patient Acceptance of Health Care - statistics & numerical data; Patient Preference; Patient Selection; Randomized Controlled Trials as Topic - methods; Randomized Controlled Trials as Topic - standards; Randomized Controlled Trials as Topic - statistics & numerical data; Research Personnel - statistics & numerical data; Trial design; Trial recruitment
• ISSN: 0266-4356; 1532-1940
• DOI: 10.1016/j.bjoms.2018.02.005

We reviewed longitudinal recruitment data to assess recruitment into head and neck cancer trials, and to identify factors that could influence this and affect their acceptability to patients. We retrieved data from the prospective computerised database (2009–2016) to measure acceptability to patients using the recruitment:screening ratio, and compared observational with interventional studies, single specialty (or site) with multispecialty (or site) studies, and “step-up” randomisation with “non-inferiority” randomisation designs. A total of 1283 patients were screened and 583 recruited. The recruitment:screening ratio for all National Institute for Health Research (NIHR) portfolio studies combined was 0.47 (486/1133). Studies that involved treatment by several specialties or at several sites had a significantly adverse impact on acceptability (p=0.01). Recruitment into non-inferiority randomised controlled studies was lower than that into step-up randomised studies (p=0.06). The complexity of a study’s design did not compromise recruitment. Treatment across several specialties or several sites and perceived non-inferiority designs, reduced the acceptability of some trials.