Reporting quality of stepped wedge design randomized trials: a systematic review protocol

Area of Science:

• Clinical Trials Methodology
• Epidemiology
• Biostatistics

Background:

• Stepped wedge design (SWD) is an increasingly utilized cluster randomized controlled trial (RCT) methodology.
• The reporting quality of SWD trials requires thorough evaluation due to its relatively novel application.
• This review addresses the knowledge gap concerning the completeness and consistency of SWD reporting.

Purpose of the Study:

• Assess SWD trial report quality using CONSORT guidelines and extensions.
• Evaluate the completeness of SWD abstracts and protocols against relevant reporting standards (CONSORT extension for abstracts, SPIRIT).
• Examine consistency between trial registration, abstracts, and main reports, and identify factors influencing reporting completeness.

Main Methods:

• Systematic literature search across major databases (MEDLINE, EMBASE, Web of Science, CINAHL, PsycINFO) for SWD trials.
• Duplicate data extraction from eligible SWD trial reports and protocols.
• Analysis of extracted data to evaluate reporting quality, identify trends, and assess consistency.

Main Results:

• Reporting quality of SWD trials will be established.
• Completeness of SWD abstracts and protocols will be assessed against CONSORT and SPIRIT guidelines.
• Consistency between trial registration, abstracts, and main reports will be evaluated.

Conclusions:

• This review will provide a comprehensive assessment of SWD reporting quality.
• Findings will inform researchers and clinicians on improving the completeness and consistency of SWD trial reporting.
• The results are expected to influence future SWD trial conduct and reporting standards.