Van Teijlingen E R, Rennie A M, Hundley V, Graham W
Department of Public Health and Dugald Baird Centre for Research on Women's Health, Medical School, University of Aberdeen, Aberdeen, UK.
J Adv Nurs. 2001 May;34(3):289-95. doi: 10.1046/j.1365-2648.2001.01757.x.
In many research papers, pilot studies are only reported as a means of justifying the methods. This justification might refer to the overall research design, or simply to the validity and reliability of the research tools. It is unusual for reports of pilot studies to include practical problems faced by the researcher(s). Pilot studies are relevant to best practice in research, but their potential for other researchers appears to be ignored.
The primary aim of this study was to identify the most appropriate method for conducting a national survey of maternity care.
Pilot studies were conducted in five hospitals to establish the best of four possible methods of approaching women, distributing questionnaires and encouraging the return of these questionnaires. Variations in the pilot studies included (a) whether or not the questionnaires were anonymous, (b) the staff involved in distributing the questionnaires and (c) whether questionnaires were distributed via central or local processes. For this purpose, five maternity hospitals of different sizes in Scotland were included.
Problems in contacting women as a result of changes in the Data Protection Act (1998) required us to rely heavily on service providers. However, this resulted in a number of difficulties. These included poor distribution rates in areas where distribution relied upon service providers, unauthorized changes to the study protocol and limited or inaccurate information regarding the numbers of questionnaires distributed.
The pilot raised a number of fundamental issues related to the process of conducting a large-scale survey, including the method of distributing the questionnaire, gaining access to patients, and reliance on 'gatekeepers'. This paper highlights the lessons learned as well as the balancing act of using research methods in the most optimal way under the combined pressure of time, ethical considerations and the influences of stakeholders. Reporting the kinds of practical issues that occur during pilot studies might help others avoid similar pitfalls and mistakes.
在许多研究论文中，预试验仅作为证明研究方法合理性的一种手段被报告。这种合理性证明可能涉及整体研究设计，或者仅仅涉及研究工具的有效性和可靠性。预试验报告中包含研究者所面临的实际问题的情况并不常见。预试验与最佳研究实践相关，但其他研究者似乎忽视了其潜在价值。
本研究的主要目的是确定进行全国性孕产妇护理调查的最合适方法。
在五家医院开展预试验，以确定四种可能的接触女性、发放问卷并促使问卷回收方法中的最佳方法。预试验的变化包括：(a)问卷是否匿名；(b)参与发放问卷的工作人员；(c)问卷是通过集中还是地方流程发放。为此，纳入了苏格兰五家不同规模的妇产医院。
由于《1998年数据保护法》的变更，在联系女性方面出现了问题，这要求我们严重依赖服务提供者。然而，这导致了一些困难。这些困难包括：在依赖服务提供者进行发放的地区发放率低、未经授权更改研究方案以及关于发放问卷数量的信息有限或不准确。
预试验提出了一些与大规模调查过程相关的基本问题，包括问卷发放方法、接触患者以及对“把关人”的依赖。本文强调了所吸取的经验教训，以及在时间、伦理考量和利益相关者影响的综合压力下以最优化方式使用研究方法时的权衡。报告预试验期间出现的各类实际问题可能有助于其他人避免类似的陷阱和错误。
