健康支援分野における実践的研究を計画する際の留意点

抄録

Research in physical education and sports sciences covers a broad range of fields from basic science such as biology to applied science such as public health. To deal with various measurement errors and biases, precautions should be taken while planning practical studies on health promotion. This article aims to introduce the implementation of randomized controlled trial (RCT) and related information that researchers should consider when creating research designs involving health promotion. Before researchers recruit study participants in a RCT, the study protocol should be registered on a suitable registry after approval from a suitable institutional review board. When creating a research protocol, various reporting guidelines such as CONSORT should be referred to. The CONSORT statement is used for improving the reporting of RCTs and focuses on minimizing the risk of bias. In accordance with the checklist, a protocol needs to be carefully planned. In particular, the definition of outcomes and calculation of sample size are important factors for designing an RCT. There are 2 types of RCTs. One is an explanatory trial designed for testing efficacy and involves the question “Can the intervention work?” The other is a pragmatic trial designed to test effectiveness and involves the question “Does the intervention work when used in normal practice?” Researchers should determine the type of trial required for their study and accordingly use key factors such as participants, interventions, and setting.