START-RWE (Structured Template for Planning and Reporting on the Implementation of Real World Evidence Studies) was developed to address the need for improved transparency and reproducibility in real-world evidence (RWE) studies.
The template includes sections on study design, data collection, data analysis, and reporting. The study design section includes questions about the study’s objectives, population, intervention, comparator, outcomes, and study period. The data collection section includes questions about the data sources, data collection methods, and data quality assurance procedures. The data analysis section includes questions about the statistical methods that will be used to analyze the data. The reporting section includes questions about the study’s findings, limitations, and implications.
The template is intended to be used by researchers and clinicians to develop and implement RWE studies in a rigorous and transparent manner. The template can also be used by funders, regulators, and other stakeholders to assess the quality of RWE studies. The publication includes a number of case studies that illustrate how the STaRT-RWE template has been used to develop and implement RWE studies.
In the context of RWE transparency and reproducibility, START-RWE is important for the following reasons:
1. Transparency: The comprehensive reporting facilitated by START-RWE allows for complete transparency in the methods and findings of RWE studies. It ensures that all important details regarding the study design, data sources, analysis methods, results, and interpretations are fully disclosed and clearly communicated. This openness supports better interpretation and use of study findings.
2. Reproducibility: Transparency leads to reproducibility. By providing a comprehensive and detailed account of the study methods, START-RWE enables other researchers to replicate the study, which is a cornerstone of scientific validation. Reproducibility also allows for the results of RWE studies to be confirmed and refined in different populations and settings, enhancing their generalizability and impact.
The STaRT-RWE template is a valuable resource for researchers and clinicians who are planning or conducting RWE studies. The template can help to ensure that RWE studies are conducted in a rigorous and transparent manner, which can improve the quality of the evidence and ultimately lead to better healthcare decision-making.


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