ArticleValue in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research2024
Assessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force.
Article in Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed.
- Key Real-World Data Management Practices for Registry Evaluation and Quality Assurance.Therapeutic innovation & regulatory science · 2026Article
- RWE Submission for European Regulators and Payers: Challenges, Uncertainties, and Opportunities.Therapeutic innovation & regulatory science · 2026Article
- Evaluation Frameworks for Clinical Foundation Models in Specific Tasks of Unstructured Medical Text Analysis: A Scoping Review.Healthcare (Basel, Switzerland) · 2026Review
- Development and Psychometric Validation of a Usability Instrument Based on ISO 25010 for Electronic Health Record Systems in Peruvian Health Care Settings: Methodological Study.JMIR human factors · 2026Article
- Digital Twin models to address long-term treatment toxicities in children and young adults with cancer.NPJ digital medicine · 2026Review
- Article
- Ensuring Reliability of Curated Electronic Health Record-Derived Data: The Validation of Accuracy for Large Language Model-/Machine Learning-Extracted Information and Data (VALID) Framework.JCO clinical cancer informatics · 2026Article
- Application effect of whole-process nursing model based on smart healthcare mode in patients undergoing Mako robot-assisted total knee arthroplasty.Journal of robotic surgery · 2026Article
- Real-world evidence from Germany: representativeness analysis and mortality endpoint validation in electronic health record-derived oncology cohorts.BMC cancer · 2026Article
- Article
- A real-world data challenge: guidance for aligning data privacy compliance and fit-for-purpose usability.Health affairs scholar · 2025Article
- Finding the right tool for the specific task: navigating RWE tools and checklists.Future oncology (London, England) · 2025Review
- Challenges in Modelling the Cost Effectiveness of Pharmacotherapies for Obesity.PharmacoEconomics · 2025Review
- The use of real-world evidence among healthcare payers: a scoping review.International journal of technology assessment in health care · 2025Article
- Key Considerations for Assessing Real-World Comparative Effectiveness in the Context of the Drug Price Negotiation Program: A Case Study of Pembrolizumab.PharmacoEconomics · 2025Article
- AI-Enabled IoT for Food Computing: Challenges, Opportunities, and Future Directions.Sensors (Basel, Switzerland) · 2025Review
- Characterisation of oncology EHR-derived real-world data in the UK, Germany, and Japan.ESMO real world data and digital oncology · 2025Review
- Use of real-world evidence in the Medicare Drug Price Negotiation Program: A checklist for the Centers for Medicare and Medicaid Services and manufacturers.Health affairs scholar · 2025Article
- Generative Artificial Intelligence for Health Technology Assessment: Opportunities, Challenges, and Policy Considerations: An ISPOR Working Group Report.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2025Review
- Lessons on the use of real-world data in medical device research: findings from the National Evaluation System for Health Technology Test-Cases.Journal of comparative effectiveness research · 2024Article
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
This ISPOR Good Practices report provides a framework for assessing the suitability of electronic health records data for use in health technology assessments (HTAs). Although electronic health record (EHR) data can fill evidence gaps and improve decisions, several important limitations can affect its validity and relevance. The ISPOR framework includes 2 components: data delineation and data fitness for purpose. Data delineation provides a complete understanding of the data and an assessment of its trustworthiness by describing (1) data characteristics; (2) data provenance; and (3) data governance. Fitness for purpose comprises (1) data reliability items, ie, how accurate and complete the estimates are for answering the question at hand and (2) data relevance items, which assess how well the data are suited to answer the particular question from a decision-making perspective. The report includes a checklist specific to EHR data reporting: the ISPOR SUITABILITY Checklist. It also provides recommendations for HTA agencies and policy makers to improve the use of EHR-derived data over time. The report concludes with a discussion of limitations and future directions in the field, including the potential impact from the substantial and rapid advances in the diffusion and capabilities of large language models and generative artificial intelligence. The report's immediate audiences are HTA evidence developers and users. We anticipate that it will also be useful to other stakeholders, particularly regulators and manufacturers, in the future.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.