Evaluation of Preclinical and Clinical Studies Published in Medical Journals of Bosnia and Herzegovina: Methodology Issues.

introductionResults of preclinical and clinical studies in medicine could be trusted only if their design and statistical analysis were appropriate.

aimThe aim of our study was to investigate whether preclinical and clinical studies published in medical journals of Bosnia and Herzegovina satisfy basic requirements for appropriate design and statistical interpretation of data.

methodsPreclinical and clinical studies published in medical journals of Bosnia and Herzegovina were retrieved from the PubMed database, and the sample for analysis was randomly chosen from the retrieved publications. Implementation rate of basic principles of experimental design (local control, randomization and replication) and rate of the most common errors in design of clinical/observational studies was established by careful reading of the sampled publications and their checking against predefined criteria.

resultsOur study showed that only a minority of experimental preclinical studies had basic principles of design completely implemented (7%), while implementation rate of single aspects of appropriate experimental design varied from as low as 12% to as high as 77%. Only one of the clinical/observational studies had none of the errors searched for (2%), and specific errors rates varied from 10% to 89%. Average impact factor of the surveyed studies was around one, and average publication date recent, less than 5 years ago.

conclusionPrevalence of preclinical studies that did not follow completely basic principles of research design, and that of clinical/observational studies with errors are high, raising suspicion to validity of their results. If incorrect and not protected against bias, results of published studies may adversely influence future research.