SPIROS 2024 - Responsible Reporting

SPIROS 2024 - Responsible Reporting (Standardized Protocol Items Recommendations for Observational Studies) is a guideline for the minimum content of an observational study protocol. We have defined the scope of the recommendations to cover three main observational study designs: cohort, case-control, and cross-sectional studies.

The SPIROS 2024 - Responsible Reporting checklist recommends a full description of what is planned; it does not prescribe how to design or conduct an observational study. By providing guidance for key content, the SPIROS recommendations aim to facilitate the drafting of high-quality observational study protocols. Adherence to SPIROS would enhance the transparency and completeness of observational study protocols for the benefit of researchers, study participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, research registries, policymakers, regulators, students, and other key stakeholders.

The SPIROS 2024 - Responsible Reporting Statement includes a 37-item checklist (Table 1) covering six main domains namely (1) general information, (2) introduction, (3) methods, (4) ethical consideration, (5) Reporting and dissemination and (6) others. An associated explanatory paper (SPIROS 2024: Explanation and Elaboration) details the rationale and supporting evidence for each checklist item, along with guidance and model examples from existing protocols. We hope that the SPIROS statement will stimulate the research community to keep writing protocols of observational studies and to improve their quality and transparency.

The SPIROS project is part of the research group Meta-Research at Maastricht University.

Contact: Prof. Dr. Maurice Zeegers

Publications and Downloads

The SPIROS Checklist

PDF link
Scoping Review

PDF link
Protocol of the SPIROS project

PDF link

Authors

Professor Dr. Lex Bouter

Professor of Methodology and Integrity
Amsterdam University Medical Centers, Department of Epidemiology and Data Science, Amsterdam Public Health Research Institute
Vrije Universiteit, Faculty of Humanities, Department of Philosophy
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Dr. Sakib Burza

Medical Director, Health In Harmony
Honorary Associate Professor of Infectious and Tropical Diseases
London School of Hygiene and Tropical Medicine
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Professor Erik Cobo

Professor Statistics & OR Dept, Barcelona-Tech, at Universitat Politècnica de Catalunya
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Professor Gary Collins

Professor of Medical Statistics
Director of the UK EQUATOR Centre
Centre for Statistics in Medicine | NDORMS | University of Oxford
Botnar Research Centre | Windmill Road | Oxford | United Kingdom
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Dr. Peter Van Dael

Senior Vice President at DSM Nutritional Products
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Professor Dr Philip Greenland

Harry W. Dingman Professor of Cardiology and Professor of Preventive Medicine at Feinberg School of Medicine, Northwestern University
Senior Editor for JAMA.
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Professor Dr Jos Kleijnen

Professor of Systematic Reviews in Health Care, Maastricht University
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Professor Dr André Knottnerus

Professor of General Practice, Netherlands School of Primary Care Research
Senior Scientist, Care and Public Health Research Institute (CAPHRI)
Maastricht University, Maastricht, The Netherlands.
Former Editor-in-chief of the Journal of Clinical Epidemiology.
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Professor Dr Carl Lachat

Professor at Ghent University
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Raman Mahajan

Phd Candidate
Maastricht University, Netherlands
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Ana Marušić

Professor of Anatomy and Chair of the Department of Research in Biomedicine and Health, University of Split School of Medicine, Split, Croatia.
Honorary Professor at the University of Edinburgh, UK.
Co-editor in Chief of the Journal of Global Health
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Professor Joseph Ross

Professor of Medicine (General Medicine) and of Public Health (Health Policy and Management), Yale-New Haven Hospital.
Co-Director of the National Clinician Scholars program (NCSP) at Yale.
Deputy Editor at JAMA.
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Professor Dr Klaas Sijtsma

Professor of methods and techniques of psychological research
Former Rector Magnificus of Tilburg University
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Professor Brat Stall

Professor at HAN University of Applied Sciences, Netherlands
Senior Researcher Radboud University Medical Centre Nijmegen, Netherlands
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Professor Ian White

Professor of Statistical Methods for Medicine, University College London, Inst of Clinical Trials &Methodology
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Professor Dr Maurice P. Zeegers

Scientific Director, Head of School Care and Public Health Research institute (CAPHRI) , Maastricht University.
Professor of Complex Genetics and Epidemiology Head of Department of Complex Genetics, Maastricht University
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