Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 17, 2020
Date Accepted: Mar 21, 2020
Standardized Protocol Items Recommendations for Observational Studies (SPIROS): Protocol for a study aimed at developing an expert-based reporting guideline for observational study protocols
ABSTRACT
Background:
Approximately 90% of currently published clinical and public health research are 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 what information 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 guideline, focusing on three 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 be conducted to 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 two-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 guideline. Following the Delphi survey, an expert driven consensus workshop will be convened to finalize the reporting guideline.
Results:
A scoping review of published protocol of observational studies has been finished. A total of 59 candidate items for protocols of observational study has been identified .this long of candidate items for the protocols of observational studies will be evaluated by experts. For this purpose, we will conduct a two-round Delphi planned to be launched by February 1st 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. This reporting guideline will facilitate and encourage researchers to prepare and register study protocols of sufficient quality, prior to data collection.
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Copyright
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