A tutorial on methodological studies: the what, when, how and why

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(2020) 20:226

COMMENTARY

Open Access

A tutorial on methodological studies: the what, when, how and why Lawrence Mbuagbaw1,2,3* , Daeria O. Lawson1, Livia Puljak4, David B. Allison5 and Lehana Thabane1,2,6,7,8

Abstract Background: Methodological studies – studies that evaluate the design, analysis or reporting of other researchrelated reports – play an important role in health research. They help to highlight issues in the conduct of research with the aim of improving health research methodology, and ultimately reducing research waste. Main body: We provide an overview of some of the key aspects of methodological studies such as what they are, and when, how and why they are done. We adopt a “frequently asked questions” format to facilitate reading this paper and provide multiple examples to help guide researchers interested in conducting methodological studies. Some of the topics addressed include: is it necessary to publish a study protocol? How to select relevant research reports and databases for a methodological study? What approaches to data extraction and statistical analysis should be considered when conducting a methodological study? What are potential threats to validity and is there a way to appraise the quality of methodological studies? Conclusion: Appropriate reflection and application of basic principles of epidemiology and biostatistics are required in the design and analysis of methodological studies. This paper provides an introduction for further discussion about the conduct of methodological studies. Keywords: Methodological study, Meta-epidemiology, Research methods, Research-on-research

Background The field of meta-research (or research-on-research) has proliferated in recent years in response to issues with research quality and conduct [1–3]. As the name suggests, this field targets issues with research design, conduct, analysis and reporting. Various types of research reports are often examined as the unit of analysis in these studies (e.g. abstracts, full manuscripts, trial registry entries). Like many other novel fields of research, meta-research has seen a proliferation of use before the development of reporting guidance. For example, this was the case with randomized trials for which risk of bias tools and * Correspondence: [email protected] 1 Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada 2 Biostatistics Unit/FSORC, 50 Charlton Avenue East, St Joseph’s Healthcare—Hamilton, 3rd Floor Martha Wing, Room H321, Hamilton, Ontario L8N 4A6, Canada Full list of author information is available at the end of the article

reporting guidelines were only developed much later – after many trials had been published and noted to have limitations [4, 5]; and for systematic reviews as well [6– 8]. However, in the absence of formal guidance, studies that report on research differ substantially in how they are named, conducted and reported [9, 10]. This creates challenges in identifying, summarizing and comparing them. In this tutorial paper, we w