Standardized Protocol Items: Recommendations for Observational Studies (SPIROS)

The study protocol is a key component of any scientific study. Without it there is no reliable way to assess the occurrence of outcome reporting bias(es). Particularly in experimental studies, but also in observational research unprotocolized research is often considered a Questionable Research Practice. Examples of observational studies are polls about public opinion, case-control comparisons, market research, cohort or panel studies, government surveys and censuses. Our preliminary research showed that a high percentage of observational research still is conducted without a study protocol and existing protocols often lack sufficient detail. This issue becomes more worrying when one realizes there is no formal guidance on what a proper study protocol should contain. SPIROS will develop a reporting guideline for study protocols of observational studies, and by doing so facilitates and encourages scientists to prepare a study protocol of sufficient quality, prior to data collection. Please find here the protocol.

Steering Group
Dr. Raman Mahajan (PhD student)
Dr. Sakib Burza (Medical Advisor, Medecins Sans Frontieres)
Prof. Lex Bouter (Professor of Methodology and Research Integrity, VU University)
Prof. Klaas Sijtsma (Professor of Social and Behaviour Sciences, Tilburg University
Prof. Andre Knottnerus (Editor in Chief, Journal of Clinical Epidemiology)
Prof. Maurice Zeegers (Professor of Complex Genetics and Epidemiology, Maastricht University)
Prof. Paolo Bofetta (Professor of Oncological Sciences, Mount Sinai)
Dr. Peter van Dael (Senior President Nutrition Science & Advocacy at DSM Nutritional Products)
Prof. Jos Kleijnen (Professor Systematic Reviews in Healthcare)