Standardized protocol items recommendations for observational studies (SPIROS) for observational study protocol reporting guidelines: Protocol for a delphi study

Raman Mahajan*, Sakib Burza, Lex M. Bouter, Klaas Sijtsma, André Knottnerus, Jos Kleijnen, Peter van Dael, Maurice P. Zeegers

*Corresponding author for this work

Research output: Contribution to JournalArticleAcademicpeer-review

78 Downloads (Pure)


BACKGROUND: Approximately 90% of currently published clinical and public health research is in the form of observational studies. Having a detailed and registered study protocol prior to data collection is important in any empirical study. Without this, there is no reliable way to assess the occurrence of publication bias, outcome reporting bias, and other protocol deviations. However, there is currently no solid guidance available on the information that a protocol for an observational study should contain.

OBJECTIVE: The aim of this study is to formulate the Standardized Protocol Items Recommendations for Observational Studies (SPIROS) reporting guidelines, which focus on 3 main study designs of analytical epidemiology: cohort, case-control, and cross-sectional studies.

METHODS: A scoping review of published protocol papers of observational studies in epidemiology will identify candidate items for the SPIROS reporting guidelines. The list of items will be extended with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist items and recommendations from the SPIROS steering committee. This long list serves as the basis for a 2-round Delphi survey among experts to obtain consensus on which items to include. Each candidate item from the long list will be rated on a 5-point Likert scale to assess relevance for inclusion in the SPIROS reporting guidelines. Following the Delphi survey, an expert-driven consensus workshop will be convened to finalize the reporting guidelines.

RESULTS: A scoping review of published observational study protocols has been completed, with 59 candidate items identified for inclusion into the Delphi survey, itself launched in early 2020.

CONCLUSIONS: This project aims to improve the timeliness, completeness, and clarity of study protocols of observational studies in analytical epidemiology by producing expert-based recommendations of items to be addressed. These reporting guidelines will facilitate and encourage researchers to prepare and register study protocols of sufficient quality prior to data collection in order to improve the transparency, reproducibility, and quality of observational studies.


Original languageEnglish
Article numbere17864
Pages (from-to)1-6
Number of pages6
JournalJMIR Research Protocols
Issue number10
Early online date21 Oct 2020
Publication statusPublished - Oct 2020


  • Delphi
  • Guidelines
  • Observational studies
  • Protocol


Dive into the research topics of 'Standardized protocol items recommendations for observational studies (SPIROS) for observational study protocol reporting guidelines: Protocol for a delphi study'. Together they form a unique fingerprint.

Cite this