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Use of Structured Template and Reporting Tool for Real-World Evidence Template for Critical Appraisal of the Quality of Reporting of Real-World Evidence Studies: A Systematic Review

  • Author Footnotes
    ∗ Kapil Khambholja and Manish Gehani contributed equally to this work.
    Kapil Khambholja
    Correspondence
    Correspondence: Kapil Khambholja, PhD, Department of Medical Writing and Real-world Evidence, Genpro Research Inc, 303 Wyman St, Ste 300, Waltham, MA 02451, USA.
    Footnotes
    ∗ Kapil Khambholja and Manish Gehani contributed equally to this work.
    Affiliations
    Department of Medical Writing and Real World Evidence, Genpro Research Inc, Waltham, MA, USA
    Search for articles by this author
  • Author Footnotes
    ∗ Kapil Khambholja and Manish Gehani contributed equally to this work.
    Manish Gehani
    Footnotes
    ∗ Kapil Khambholja and Manish Gehani contributed equally to this work.
    Affiliations
    Department of Medical Writing and Real World Evidence, Genpro Research Pvt Ltd, Thiruvananthapuram, India
    Search for articles by this author
  • Author Footnotes
    ∗ Kapil Khambholja and Manish Gehani contributed equally to this work.
Published:October 06, 2022DOI:https://doi.org/10.1016/j.jval.2022.09.003

      Highlights

      • Real-world evidence (RWE) studies are increasingly being used to generate supportive evidence regarding safety, effectiveness, and generalizability of medicinal products or interventions for healthcare decision makers, whereas methods and findings of these studies are full of ambiguity, assumptions, or misinterpretations.
      • This study did critical assessment of the quality of reporting of the published RWE studies using the Structured Template and Reporting Tool for RWE template and uncovered many deficiencies, which could have affected the robustness of the evidence.
      • Structured Template and Reporting Tool for RWE template has a potential of improving robustness of the RWE studies and should be used for planning, implementing, and reporting such studies.

      Objectives

      Real-world evidence (RWE) studies are increasingly being used to support healthcare decisions. Various frameworks, tools, and checklists exist for ensuring quality of real-world data, designing robust studies, and assessing potential for bias. In January 2021, Structured Template and Reporting Tool for RWE (STaRT-RWE) was released to further reduce ambiguity, assumptions, and misinterpretation while planning, implementing, and reporting RWE studies of the safety and effectiveness of treatments. The objective of this study was to identify gaps in the reporting quality of published RWE studies by using this template for critical appraisal.

      Methods

      Two reviewers conducted a keyword search on PubMed for free-full-text research articles using real-world data, RWE design, and safety with or without effectiveness outcomes of a medicinal product or intervention in humans of any age or gender, published in English between January 13, 2021, and January 13, 2022. Assessment of risk of bias was done using Assessment of Real-World Observational Studies critical appraisal tool. Deficiencies in methods and findings as per STaRT-RWE template were reported as frequencies.

      Results

      A total of 54 of 2374 retrieved studies were included in the review. Based on the STaRT-RWE template, the studies inadequately reported empirically defined covariates, power and sample size calculation, attrition, sensitivity analyses, index date (day 0) defining criterion, predefined covariates, outcome, metadata about data source and software, objective, inclusion and exclusion criteria, analysis specifications, and follow-up.

      Conclusions

      The use of STaRT-RWE template along with its tables, design diagram, and library of published studies has a potential of improving robustness of RWE studies.

      Keywords

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