Reporting of health equity considerations in cluster and individually randomized trials

Important considerations in calculating and reporting of sample size in randomized controlled trials

Background: The calculation of the sample size is one of the most important steps in designing a randomized controlled trial. The purpose of this study is drawing the attention of researchers to the importance of calculating and reporting the sample size in randomized controlled trials.    Methods: We reviewed related literature and guidelines and discussed some important issues in s...

Protocol for the development of a CONSORT-equity guideline to improve reporting of health equity in randomized trials

BACKGROUND Health equity concerns the absence of avoidable and unfair differences in health. Randomized controlled trials (RCTs) can provide evidence about the impact of an intervention on health equity for specific disadvantaged populations or in general populations; this is important for equity-focused decision-making. Previous work has identified a lack of adequate reporting guidelines for a...

Cluster Randomized Trials and Equivalence Trials

Considerations and guidance in designing equity-relevant clinical trials

Health research has documented disparities in health and health outcomes within and between populations. When these disparities are unfair and avoidable they may be referred to as health inequities. Few trials attend to factors related to health inequities, and there is limited understanding about how to build consideration of health inequities into trials. Due consideration of health inequitie...

Ethical issues posed by cluster randomized trials in health research

The cluster randomized trial (CRT) is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly thei...