Centre for Surgical Research and Medical Research Council (MRC) ConDuCT-II Hub for Trials Methodology Research, Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
MRC North West Hub for Trials Methodology Research, University of Liverpool, Liverpool, UK.
Br J Surg. 2019 Jul;106(8):968-978. doi: 10.1002/bjs.11167. Epub 2019 May 10.
RCTs in surgery are challenging owing to well established methodological issues. Well designed pilot and feasibility studies (PFS) may help overcome such issues to inform successful main trial design and conduct. This study aimed to analyse protocols of UK-funded studies to explore current use of PFS in surgery and identify areas for practice improvement.
PFS of surgical interventions funded by UK National Institute for Health Research programmes from 2005 to 2015 were identified, and original study protocols and associated publications sourced. Data extracted included study design characteristics, reasons for performing the work including perceived uncertainties around conducting a definitive main trial, and whether the studies had been published.
Thirty-five surgical studies were identified, of which 29 were randomized, and over half (15 of 29) included additional methodological components (such as qualitative work examining recruitment, and participant surveys studying current interventions). Most studies focused on uncertainties around recruitment (32 of 35), with far fewer tackling uncertainties specific to surgery, such as intervention stability, implementation or delivery (10 of 35). Only half (19 of 35) had made their results available publicly, to date.
The full potential of pretrial work to inform and optimize definitive surgical studies is not being realized.
由于已确立的方法学问题，外科手术中的 RCT 具有挑战性。精心设计的试验前和可行性研究（PFS）可能有助于克服这些问题，为成功的主要试验设计和实施提供信息。本研究旨在分析英国资助的研究方案，以探讨当前外科手术中 PFS 的使用情况，并确定实践改进的领域。
确定了英国国家卫生研究院（NIHR）从 2005 年至 2015 年资助的外科干预措施的 PFS，并找到了原始研究方案和相关出版物。提取的数据包括研究设计特征、开展工作的原因，包括对进行确定性主要试验的不确定性的认识，以及这些研究是否已发表。
确定了 35 项外科研究，其中 29 项为随机研究，超过一半（29 项中的 15 项）包括其他方法学组成部分（如检查招募的定性工作，以及研究当前干预措施的参与者调查）。大多数研究集中在招募方面的不确定性（35 项中的 32 项），而很少有研究针对手术特定的不确定性，如干预的稳定性、实施或交付（35 项中的 10 项）。迄今为止，只有一半（35 项中的 19 项）公开了他们的结果。
未充分实现试验前工作为确定性外科研究提供信息和优化的全部潜力。
