pilotstudies

Pilotstudies are small-scale investigations conducted before a larger research project to test and refine aspects of the study design. They aim to assess feasibility, including recruitment and retention capabilities, data collection procedures, intervention delivery, and logistical issues. Pilotstudies are not expected to provide definitive answers about effectiveness, but they help identify uncertainties and guide the planning of a full-scale study.

They may be randomized or non-randomized; sample sizes are small and mainly descriptive; outcomes often focus on process measures rather than efficacy. The work is typically used to optimize procedures, train staff, and identify potential problems in data capture or intervention implementation.

Pilotstudies inform sample size calculations for the main study by providing preliminary estimates and variance, though estimates from pilot data carry uncertainty. Criteria to progress to a full trial are often predefined; such progression criteria help decide whether to proceed, modify, or stop.

Common pitfalls include mislabeling feasibility as efficacy, overinterpreting non-significant results, ignoring adjustments required for scaling up, lack of appropriate controls, or not reporting protocol deviations. Ethical considerations require appropriate approvals and informed consent, with transparent reporting of methods and results.

Examples of pilotstudies include testing recruitment strategies, refining survey instruments, trialing data collection software, or piloting an intervention protocol. By addressing practical questions early, pilotstudies aim to improve the likelihood that a subsequent full-scale study is feasible, efficient, and informative.