pilotstudier

Pilotstudier are small-scale, preliminary studies conducted before a full-scale main study to assess feasibility and refine procedures. They help researchers test whether the planned study design, instruments, recruitment strategies, data collection methods, and analysis plans are workable in practice. By identifying logistical problems early, pilotstudier aim to reduce risks for the subsequent larger study.

Pilotstudier are not primarily intended to provide definitive answers about effectiveness or outcomes. Instead, they focus on feasibility-related questions: Can recruitment targets be met? Are the data collection tools clear and usable? Is randomization and blinding feasible? What is the expected burden on participants? They may also offer preliminary estimates of variance to inform sample size calculations for the main study, but results are considered exploratory and should be interpreted with caution.

Designs of pilotstudier vary; they can be smaller or shorter in duration, and may be single-arm or randomized. They often involve close monitoring of processes, staff training, and trial runs of data management systems. Reporting should clearly differentiate feasibility findings from any preliminary effectiveness observations, and cautious language should be used.

Ethical approval is typically required, as with any research involving human participants. If a pilotstudy demonstrates feasibility, and resources permit, researchers may proceed to the full-scale study, possibly revising the protocol based on the pilot’s lessons.