Abstract
BackgroundApproximately 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.ObjectiveThe 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.MethodsA 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.ResultsA 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.ConclusionsThis 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.International Registered Report Identifier (IRRID)PRR1-10.2196/17864
Highlights
The protocol of any empirical study offers the researcher practical guidance in data collection, analysis, and reporting
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
The value of registered study protocols and reporting guidelines on how to write them are widely recognized in the field of randomized control trials (RCTs) [3,4,5], reporting guidelines for study protocols of observational studies in analytical epidemiology are currently absent
Summary
The protocol of any empirical study offers the researcher practical guidance in data collection, analysis, and reporting. It forms the basis for subsequent replication of the study and detection of publication bias, outcome reporting bias, and other protocol deviations. A well-formulated study protocol uploaded prior to data collection through a time-stamped registry will allow a robust audit trail. This improves the chances that the study is appropriately planned, executed, and well documented, promoting optimal conduct, accountability, replicability, and overall research integrity. There is currently no solid guidance available on the information that a protocol for an observational study should contain
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