ArticleJournal of the American Medical Informatics Association : JAMIA2018
The representativeness of eligible patients in type 2 diabetes trials: a case study using GIST 2.0.
Article in Journal of the American Medical Informatics Association : JAMIA, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Eligibility of Asian and European registry patients for phase III trials in heart failure with reduced ejection fraction.ESC heart failure · 2024Article
- The association between sodium glucose cotransporter-2 inhibitors vs dipeptidyl peptidase-4 inhibitors and renal outcomes in people discharged from hospital with type 2 diabetes: A population-based cohort study.Journal of diabetes · 2024Article
- Patterns of Telemedicine Use and Glycemic Outcomes of Endocrinology Care for Patients With Type 2 Diabetes.JAMA network open · 2023Article
- Medical concept normalization in clinical trials with drug and disease representation learning.Bioinformatics (Oxford, England) · 2021Article
- From clinical trials to clinical practice: How long are drugs tested and then used by patients?Journal of the American Medical Informatics Association : JAMIA · 2021Article
- Applicability of Transcatheter Aortic Valve Replacement Trials to Real-World Clinical Practice: Findings From EXTEND-CoreValve.JACC. Cardiovascular interventions · 2021Article
- The Problem of Fairness in Synthetic Healthcare Data.Entropy (Basel, Switzerland) · 2021Article
- A Framework for Systematic Assessment of Clinical Trial Population Representativeness Using Electronic Health Records Data.Applied clinical informatics · 2021Article
- Contemporary use of real-world data for clinical trial conduct in the United States: a scoping review.Journal of the American Medical Informatics Association : JAMIA · 2021Article
- Representation of people with comorbidity and multimorbidity in clinical trials of novel drug therapies: an individual-level participant data analysis.BMC medicine · 2019Article
- Dapagliflozin and cardiovascular mortality and disease outcomes in a population with type 2 diabetes similar to that of the DECLARE-TIMI 58 trial: A nationwide observational study.Diabetes, obesity & metabolism · 2019Observational
- How representative of a general type 2 diabetes population are patients included in cardiovascular outcome trials with SGLT2 inhibitors? A large European observational study.Diabetes, obesity & metabolism · 2019Observational
- How Many Patients with Type 2 Diabetes Meet the Inclusion Criteria of the Cardiovascular Outcome Trials with SGLT2 Inhibitors? Estimations from a Population Database in a Mediterranean Area.Journal of diabetes research · 2019Article
Corrections and comments
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Authors and funding
8 authors.
Funding
Abstract
objectiveThe population representativeness of a clinical study is influenced by how real-world patients qualify for the study. We analyze the representativeness of eligible patients for multiple type 2 diabetes trials and the relationship between representativeness and other trial characteristics.
methodsSixty-nine study traits available in the electronic health record data for 2034 patients with type 2 diabetes were used to profile the target patients for type 2 diabetes trials. A set of 1691 type 2 diabetes trials was identified from ClinicalTrials.gov, and their population representativeness was calculated using the published Generalizability Index of Study Traits 2.0 metric. The relationships between population representativeness and number of traits and between trial duration and trial metadata were statistically analyzed. A focused analysis with only phase 2 and 3 interventional trials was also conducted.
resultsA total of 869 of 1691 trials (51.4%) and 412 of 776 phase 2 and 3 interventional trials (53.1%) had a population representativeness of <5%. The overall representativeness was significantly correlated with the representativeness of the Hba1c criterion. The greater the number of criteria or the shorter the trial, the less the representativeness. Among the trial metadata, phase, recruitment status, and start year were found to have a statistically significant effect on population representativeness. For phase 2 and 3 interventional trials, only start year was significantly associated with representativeness.
conclusionsOur study quantified the representativeness of multiple type 2 diabetes trials. The common low representativeness of type 2 diabetes trials could be attributed to specific study design requirements of trials or safety concerns. Rather than criticizing the low representativeness, we contribute a method for increasing the transparency of the representativeness of clinical trials.
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What OpenQuestion holds
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.