The importance of conducting and reporting pilot studies: the example of the Scottish Births Survey.

BACKGROUND 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. OBJECTIVE The primary aim of this study was to identify the most appropriate method for conducting a national survey of maternity care. METHODS 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. RESULTS 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. CONCLUSIONS 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.