Value of surgical pilot and feasibility study protocols
Value of surgical pilot and feasibility study protocols
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DOI：
10.1002/bjs.11167
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发表时间：
2019-07-01
影响因子：
9.6
通讯作者：
Avery, K. N. L.
中科院分区：
文献类型：
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作者：
Fairhurst, K.;Blazeby, J. M.;Avery, K. N. L.
背景：由于公认的方法学问题，外科随机对照试验具有挑战性。设计良好的试验和可行性研究(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参考。本研究旨在分析英国资助的研究方案，以探索目前PFS在外科手术中的使用情况，并确定需要改进的领域。方法：确定2005-2015年间由英国国家卫生研究所资助的外科干预措施的PFS，并获取原始研究方案和相关出版物。结果：共确定了35项外科研究，其中29项是随机的，超过一半(15项)包含了额外的方法学成分(如定性工作检查招募，参与者调查研究当前的干预措施)。大多数研究集中在招募方面的不确定性(35人中的32人)，很少涉及手术的不确定性，如干预的稳定性、实施或交付(35人中的10人)。到目前为止，只有一半(35人中的19人)公开了他们的结果。结论：审判前工作的全部潜力还没有被实现，以告知和优化明确的外科研究。
Background: 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.Methods: 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.Results: 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.Conclusion: The full potential of pretrial work to inform and optimize definitive surgical studies is not being realized.