Who is RIGOROUS for?

  • Investigators, for designing, conducting, or reporting studies using routinely collected health data, in academia, industry, government, and third-sector settings.

  • Regulators, HTA bodies, and other evidence users, for assessing whether a study was designed to answer the question it addresses.

  • Editors and peer reviewers, for evaluating whether a study's aims, methods, results, and conclusions are aligned and appropriate.

  • Educators, for teaching structured study design and connecting decisions and principles that are often taught in isolation.

  • Trainees, for planning and reporting research using routinely collected health data.

How to Use It

RIGOROUS is designed to be used throughout the research pipeline but is primarily intended for use during the study design and manuscript drafting stages. Working through the eight steps while designing a study protocol is intended to help researchers ensure that key decisions, around the estimand, dataset, and analysis approach, are considered and refined up front. During manuscript preparation, the framework is intended to enable researchers to demonstrate that methodological standards have been met, with steps U7 and S8 providing explicit guidance on language and reporting expectations.

An iterative framework

Although the eight RIGOROUS steps are presented as a sequence, the framework is intended to be used iteratively. All steps should therefore be considered at all stages of the research process. This is because engagement with later steps may reveal that earlier changes are necessary. For example, if the data are not fit for purpose for a particular estimand (G3) then the estimand may need refining (I2). Similarly, if certain assumptions checks fail (O6), then the analytical approach (R5) may need refining.

A choice of formats

The framework materials are available in two formats: guidance tables and questionnaires. The guidance tables serve as ongoing resources to consult throughout the research process, particularly during study design and analysis planning. The questionnaires allow investigators to document their adherence to the framework during manuscript preparation. They are available as downloadable PDFs for each task and as an integrated online tool, which allows users to save, return, and refine their answers throughout the project.