Research Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London WC1E 7HB, UK.
BMC Med Res Methodol. 2013 Jun 13;13:78. doi: 10.1186/1471-2288-13-78.
Conducting a pilot trial is important in preparing for, and justifying investment in, the ensuing larger trial. Pilot trials using the same design and methods as the subsequent main trial are ethically and financially advantageous especially when pilot and main trial data can be pooled. For explanatory trials in which internal validity is paramount, there is little room for variation of methods between the pilot and main trial. For pragmatic trials, where generalisability or external validity is key, greater flexibility is written into trial protocols to allow for 'real life' variation in procedures. We describe the development of a checklist for use in decision-making on whether pilot data can be carried forward to the main trial dataset without compromising trial integrity. We illustrate the use of the checklist using a pragmatic trial of psychosocial interventions for family carers of people with dementia as a case study.
开展试点试验对于准备和证明随后更大规模试验的投资非常重要。使用与后续主要试验相同设计和方法的试点试验在伦理和经济上都是有利的，特别是当试点和主要试验数据可以合并时。对于解释性试验，内部有效性至关重要，因此在试点和主要试验之间几乎没有方法变化的余地。对于实用性试验，其中普遍性或外部有效性是关键，试验方案中写入了更大的灵活性，以允许程序在“现实生活”中发生变化。我们描述了制定一份清单的过程，用于在不影响试验完整性的情况下，决定是否可以将试点数据转移到主要试验数据集。我们使用针对痴呆患者家庭照顾者的心理社会干预实用性试验作为案例研究来说明清单的使用。
