Item 6. Methods: study design.

The design and key features of the evaluation (cross referencing to any appropriate methodology reporting standards) and any changes to study protocol, with reasons

Examples - Study design

The trial was designed as an implementation study with a before and after analysis.25

Implementation of Perioperative Safety Guidelines is a multicenter study in nine hospitals using an one-way (unidirectional) cross-over cluster trial design… It is impossible to deliver such a strategy simultaneously to all hospitals because of logistical, practical, and financial reasons. For that reason, a stepped wedge cluster randomized trial design is chosen.26

Explanation The study design should be identified and the rationale explained. Any important changes to the study protocol should be described (or the absence of changes confirmed). In contrast to most reporting standards, StaRI is applicable to a broad range of study designs, for example, cluster RCTs, controlled clinical trials, interrupted time series, cohort, case study, before and after studies, as well as mixed methods quantitative/qualitative assessments.2 A hierarchy of study design has been suggested in the context of studies implementing asthma self-management.4 Reporting standards exist for many of these designs such as cluster RCTs,27 pragmatic RCTs,28 observational studies,29 including use of routine data,30 non-randomised public health interventions,31 qualitative studies,32 as well as templates for describing interventions33 and local quality improvement initiatives.34 The StaRI checklist does not, therefore, include items related to specific design features (eg, randomisation, blinding, intracluster correlation, matching criteria for cohorts, data saturation). Authors are referred to appropriate methodological guidance on reporting these aspects of their study (available from http://www.equator-network.org).