QUALITY OF PUBLISHED REAL WORLD EVIDENCE ARTICLES BASED ON RETROSPECTIVE DATABASE ANALYSIS USING THE STRWE-RETRO CHECKLIST

Author(s)

Pandey P1, Pandey R2
1SIRO Clinpharm Pvt Ltd, Maharashtra, India, 2SIRO Clinpharm Pvt Ltd, Thane, MH, India

Objective: The previously developed 28-item checklist to standardize the reporting of retrospective database analysis (RDA)–based real-world evidence (RWE) studies (StRWE-Retro, ISPOR 2018) was used to assess the quality of published RWE articles in oncology and neuroscience. Method: A literature search was conducted to identify RDA–based RWE articles published between 2008 and 2018. Two experienced publication writers (PWs) assessed quality of these articles using StRWE-Retro. Articles that reported ≥25 items were considered high quality (HQ). Data for variables that may potentially influence the quality of articles were collected. These variables included, the study statistician (lead data analyst) as an author, the study statistician as the lead author, assistance of a PW in manuscript development, source of funding (industry, academic), speciality of the lead author (clinical, other), journal’s impact factor (high [>5], low [≤5]), and journal’s speciality (clinical, other), adherence to any reporting guidelines. The association of these variables with quality of articles was estimated using Chi-square test of independence. Results: Of 100 retrieved articles that met the inclusion criteria, 37 (37%) were HQ. The quality of articles was not significantly associated with most of the variables except one, the study statistician as the lead author (p=0.04571). None of these articles reported whether any reporting guidelines were followed. Conclusion: Quality of these RDA-based RWE articles was not significantly associated with most of the variables examined. Significant association with study statistician as the lead infers the complexity of study design and data analysis involved in RWE studies; therefore, specialized trainings of PW may further improve quality of RWE manuscripts. The checklist should be validated with a larger number of studies and involvement of more experts.

Conference/Value in Health Info

2019-05, ISPOR 2019, New Orleans, LA, USA

Value in Health, Volume 22, Issue S1 (2019 May)

Code

PNS31

Topic

Real World Data & Information Systems

Topic Subcategory

Reproducibility & Replicability

Disease

No Specific Disease

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