ISPOR Good Research Practices for Retrospective Database Analysis Checklist (Part I)
A checklist to help researchers properly design, report, and understand studies that use existing health data from sources like insurance claims or electronic health records, especially when comparing treatments.
At a glance
Use when
Conducting nonrandomized studies using existing databases for comparative effectiveness research
Avoid when
Primary data collection is planned or required; when real-world data are not relevant or available
Inputs
Secondary health data (e.g., claims, electronic health records), research question, study population, exposure and outcome definitions
Outputs
Methodologically sound, transparently reported retrospective database analysis
How it works
A standardized checklist developed by the ISPOR Task Force to guide the conduct and reporting of nonrandomized, retrospective database studies in comparative effectiveness research, ensuring methodological rigor and transparency in defining study elements, data sources, and analytical approaches.
- HTA domains
- Clinical Effectiveness, Costs & Economic Evaluation, Safety
- Assumptions
- Data quality is sufficient; data sources are appropriate for the research question; proper statistical methods are applied to address biases
- Strengths
- Promotes consistency and rigor in retrospective studies; enhances transparency and reproducibility; developed by an expert task force
- Limitations
- May not cover all nuances of diverse data sources; limited guidance on specific statistical techniques for bias adjustment
Questions this answers
References & sources
Similar by meaning
- ISPOR Retrospective Database Analysis Good Research Practices — Part III (Analytic Methods)
- ISPOR Prospective Observational Studies to Assess Comparative Effectiveness Good Research Practices Task Force Report
- Guidelines for Good Database Selection and Use in Pharmacoepidemiology Research
- GRACE Checklist (Good ReseArch for Comparative Effectiveness)
- CODE-EHR best-practice framework
Beta record. Based on the original catalogue summary; primary-source enrichment pending.