ArticlePharmacoepidemiology and drug safety2021
Real-world reproducibility study characterizing patients newly diagnosed with multiple myeloma using Clinical Practice Research Datalink, a UK-based electronic health records database.
Article in Pharmacoepidemiology and drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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The trial behind it
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Who cites it
5 citing papers in PubMed.
- Bridging Randomized Trial Efficacy and Real-World Effectiveness in Multiple Myeloma: Integrating Clinical Trials and Real-World Evidence for Individualized Care.European journal of haematology · 2026Review
- Impact of Season and Other Factors on Initiation, Discontinuation, and Switching of Systemic Drug Therapy in Patients with Psoriasis: A Retrospective Study.JID innovations : skin science from molecules to population health · 2023Article
- The Implication of Latent Information Quality to the Reproducibility of Secondary Use of Electronic Health Records.Studies in health technology and informatics · 2022Article
- Clinical features and diagnosis of multiple myeloma: a population-based cohort study in primary care.BMJ open · 2021Article
- Real-world reproducibility study characterizing patients newly diagnosed with multiple myeloma using Clinical Practice Research Datalink, a UK-based electronic health records database.Pharmacoepidemiology and drug safety · 2021Article
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeWe evaluated the reproducibility of a study characterizing newly-diagnosed multiple myeloma (MM) patients within an electronic health records (EHR) database using different analytic tools.
methodsWe reproduced the findings of a descriptive cohort study using an iterative two-phase approach. In Phase I, a common protocol and statistical analysis plan (SAP) were implemented by independent investigators using the Aetion Evidence Platform® (AEP), a rapid-cycle analytics tool, and SAS statistical software as a gold standard for statistical analyses. Using the UK Clinical Practice Research Datalink (CPRD) dataset, the study included patients newly diagnosed with MM within primary care setting and assessed baseline demographics, conditions, drug exposure, and laboratory procedures. Phase II incorporated analysis revisions based on our initial comparison of the Phase I findings. Reproducibility of findings was evaluate by calculating the match rate and absolute difference in prevalence between the SAS and AEP study results.
resultsPhase I yielded slightly discrepant results, prompting amendments to SAP to add more clarity to operational decisions. After detailed specification of data and operational choices, exact concordance was achieved for the number of eligible patients (N = 2646), demographics, comorbidities (i.e., osteopenia, osteoporosis, cardiovascular disease [CVD], and hypertension), bone pain, skeletal-related events, drug exposure, and laboratory investigations in the Phase II analyses.
conclusionsIn this reproducibility study, a rapid-cycle analytics tool and traditional statistical software achieved near-exact findings after detailed specification of data and operational choices. Transparency and communication of the study design, operational and analytical choices between independent investigators were critical to achieve this reproducibility.
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