PD Dr. med. Dr. phil Stefan Schandelmaier

Health researchers rely on methods guidance to make decisions about study design, data collection, analysis, reporting, and interpretation. Yet important questions remain about how to develop guidance that reflects methodological evidence and meets researchers’ needs.

STREAM develops practical recommendations for creating trustworthy and useful methods guidance. It addresses how developers can involve relevant people, select and use methodological evidence, formulate recommendations, and present guidance that researchers can understand and apply.

The project combines reviews of existing recommendations and current guidance development practices with interviews with guidance users. An international panel will use these findings to draft STREAM. Guidance developers will then test the recommendations in ongoing projects and provide feedback to refine them.

Stefan Schandelmaier leads STREAM at the University of Basel and University Hospital Basel, working with Malena Chiaborelli, Matthias Briel, and international collaborators.

The Swiss National Science Foundation supports the project through an Ambizione grant.

Project website: stream.methods-research.org

Methods research develops, evaluates, and improves the methods we use in health research. Researchers use many different approaches, but inconsistent names and unclear definitions make this work harder to plan, find, and build on.

TYPE-ME provides a shared framework for describing methods research. It distinguishes 15 approaches (how researchers conduct a study) and 14 objectives (what they aim to achieve). For example, researchers might use a simulation study to compare statistical methods, or a consensus study to develop a reporting guideline.

An international team of 11 methodologists, including Stefan Schandelmaier, Malena Chiaborelli, Julian Hirt, and Matthias Briel, developed TYPE-ME through discussion, written feedback, and testing.

Researchers and educators can use TYPE-ME to plan and report studies, review methodological evidence, and teach methods research. The team continues to refine the typology and welcomes feedback from users.

Explore the interactive overview, definitions, examples, and explanations at methods-research.org

EU-RESPONSE is a 5-year project that includes two European Adaptive Platform Trials: DisCoVeRy and EU-SolidAct. The EU-RESPONSE consortium is composed of 22 partners, bringing together multidisciplinary partners from across the continent.

The group at the Division of Clinical Epidemiology is part of the methods and statistical group and co-leads specific meta-research projects such as several individual participant data meta-analyses (IPDMAs).

So war, we have conducted two large-scale IPDMAs to summarise all available randomised evidence on a) remdesivir and b) JAK inhibitors among hospitalised COVID-19 patients. Both IPDMAs contained more than >10'000 randomized patient data from more than 10 trial teams. The remdesivir IPDMA was published in The Lancet Respiratory Medicine, directly influenced the NICE guidelines in the UK, received high media attention, was cited in two editorials, and presented at the prestigious CROI conference 2023. The JAK inhibitor IPDMA (https://www.jakinhibitoripdma.org/) is currently under review at The Lancet Resp Med and in discussion at the WHO COVID-19 guidelines team for the upcoming update of their treatment guidelines.

Subgroup analyses can reveal differences in treatment effects between patient groups, but chance and analytical choices frequently produce misleading findings. ICEMAN helps researchers judge how credible these findings are.

The instrument has separate versions for randomized controlled trials and meta-analyses of randomized trials. It guides users through questions about prior hypotheses, earlier evidence, statistical support, and analytical choices. Users weigh these considerations to rate overall credibility from very low to high.

Stefan Schandelmaier led the development of ICEMAN with an international team. The team published the instrument in 2020. ICEMAN work toegtehr with Cochrane reviews and the GRADE approach.

Access the assessment forms, online tool, user manual, and reporting templates at iceman.help

Finding useful methods guidance can be difficult. Relevant articles appear across many journals, use inconsistent terminology, and often lack adequate indexing in general research databases.

LIGHTS brings this literature together in a freely accessible, searchable database. It covers guidance for planning, conducting, analysing, reporting, and appraising health research, including tutorials, methodological recommendations, reporting guidelines, and quality assessment tools.

Users can narrow their searches by study type, methodological topic, research context, and type of guidance. The search also matches alternative terms for methodological concepts, helping users find relevant articles even when authors use different terminology.

Stefan Schandelmaier founded LIGHTS. An international team of health researchers, methodologists, and information specialists develops and maintains the collection. LIGHTS helps researchers make methodological choices, educators find teaching resources, and guidance developers build on existing work. We also use it to research methods guidance as a study type.

Search the library at lights.science