The specific methodological features of scientific research in the field of balneotherapy

Abstract

This review was undertaken for the objective of highlighting and assessing the approaches to obtaining, analysis, and reporting the results of randomized controlled trials (RCT) in balneotherapy. The review covers the following topics: the specific features of the organization of the controlled randomized studies in the field of balneotherapy, the main methodological approaches used for these purposes that should be taken into consideration at different stages of the planning and performance of the studies together with other issues including sample size calculation, sequence generation modes, the application of the distribution concealment technique, types of randomization, blinding of the outcome assessment, the choice of the comparator group, and endpoint selection. We emphasize the importance of the appropriate statistical analysis and the comprehensive reporting of the results of the investigations. Special attention is given to the current approaches to the estimation of the quality of RCTs and to the preparation of the systematic reviews. The examples of the analysis of the relevant publications presented in the review will hopefully help the researchers to take advantage of the currently available experience and improve the compliance of the locally conducted balneotherapeutic trials with the international criteria for the methodological quality.