Ho M W, Pick A S, Sutton D N, Dyker K, Cardale K, Gilbert K, Johnson J, Quantrill J, McCaul J A
Head and Neck Research, Bradford Institute of Health Research, Bradford Teaching Hospitals NHS Foundation Trust, West Yorkshire, UK; Oral and Maxillofacial Surgery, Leeds Dental Institute, University of Leeds, West Yorkshire LS2 9LU, UK.
Head and Neck Research, Bradford Institute of Health Research, Bradford Teaching Hospitals NHS Foundation Trust, West Yorkshire, UK.
Br J Oral Maxillofac Surg. 2018 May;56(4):278-282. doi: 10.1016/j.bjoms.2018.02.005. Epub 2018 Mar 6.
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.
我们回顾了纵向招募数据，以评估头颈癌试验的招募情况，并确定可能影响招募且影响患者对试验接受度的因素。我们从前瞻性计算机数据库（2009 - 2016年）中检索数据，使用招募:筛查比来衡量患者的接受度，并比较了观察性研究与干预性研究、单专科（或单中心）与多专科（或多中心）研究，以及“逐步递增”随机化与“非劣效性”随机化设计。总共筛查了1283名患者，招募了583名。所有英国国家卫生研究院（NIHR）组合研究的招募:筛查比为0.47（486/1133）。涉及多个专科或多个地点进行治疗的研究对接受度有显著不利影响（p = 0.01）。非劣效性随机对照研究的招募率低于逐步递增随机研究（p = 0.06）。研究设计的复杂性并未影响招募。多个专科或多个地点的治疗以及感知到的非劣效性设计降低了一些试验的接受度。
