Pilot studies: Are they appropriately reported?

introductionPilot studies play a pivotal role in deciding whether a main study can be undertaken thereby helping in appropriate framing of time, cost and study methods. However, they cannot be employed for testing a hypothesis and are underpowered in detecting clinically significant differences between the treatment arms. Literature from the west has shown serious lacunae on the part of researchers in reporting pilot studies. The present study assessed the reporting quality of pilot studies published from India. MATERIALS AND

methodsAll the journal articles with a pilot study design published in Indian Journals between January and December 2013 were identified through PubMed search and were assessed for the following: Reason for undertaking the pilot study; report about intention of further work; mention about sample size calculation; statement on other studies evaluating the same hypothesis published elsewhere; whether any hypothesis was tested in the present study; use of inferential statistics including the total number of statistical analyses performed and whether confidence intervals were reported; post-hoc power calculation; application of randomization and/or blinding; total number of study participants and presence of a control group.

resultsA total of 93 articles were considered in the present study. None of these reported reasons for undertaking the present pilot study and intention to carry of carrying out further work depending on their results. Also, none of them discussed the feasibility of conducting such studies in the given set-up. A total of 69/93 (67.7%) studies tested a hypothesis and had employed at least one of the statistical tests to infer whether any significant difference exist between various groups. None of the 93 articles mentioned confidence intervals and calculation of the sample size despite all mentioning the presence of previous studies evaluating a similar hypothesis. Similarly, none of these studies mentioned post-hoc analysis of power and median (range) of times of statistical analyses performed includes 5 (0-57).

conclusionPilot studies have been poorly reported in Indian biomedical journals, and more attention is required from all the stakeholders of research; researchers, peer reviewers and journal editors.