Recruitment of patients into head and neck clinical trials: acceptability of studies to patients from perspective of the research team. Issue 4 (May 2018)

• Record Type: Journal Article
• Authors: Ho, M.W.; Pick, A.S.; Sutton, D.N.; Dyker, K.; Cardale, K.; Gilbert, K.; Johnson, J.; Quantrill, J.; McCaul, J.A.
• Is Part Of: British journal of oral and maxillofacial surgery. Volume 56:Issue 4(2018)
• Page Start: 278
• Page End: 282
• Publication Date: 2018-05
• Subjects: Clinical trials -- Head and Neck research -- Trial recruitment -- Acceptability clinical trials -- Trial design; Mouth -- Surgery -- Periodicals; Maxilla -- Surgery -- Periodicals; Face -- Surgery -- Periodicals; Surgery, Plastic -- Periodicals; Dentistry, Operative -- Periodicals; Face -- surgery -- Periodicals; Mouth -- surgery -- Periodicals; Maxilla -- surgery -- Periodicals; Surgery, Oral -- Periodicals; Oral Surgical Procedures -- Periodicals; Dentistry, Operative -- Periodicals; Bouche -- Chirurgie -- Périodiques; Maxillaire supérieur -- Chirurgie -- Périodiques; Face -- Chirurgie -- Périodiques; Chirurgie dentaire -- Périodiques; Dentistry, Operative; Face -- Surgery; Maxilla -- Surgery; Mouth -- Surgery; Surgery, Plastic; Electronic journals; Periodicals; 617.52059
• DOI: 10.1016/j.bjoms.2018.02.005
• Languages: English
• ISSNs: 0266-4356

Abstract

Abstract: 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.