ArticlePharmacoepidemiology and drug safety2017
Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0.
Article in Pharmacoepidemiology and drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04212390 (Personalized Medicine Program on Myelodysplastic Syndromes), which is not on this map. Cited by 83 papers, 4 of them syntheses that pooled it.
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.
Personalized Medicine Program on Myelodysplastic Syndromes: Characterization of the Patient's Genome for Clinical Decision Making and Systematic Collection of Real World Data to Improve Quality of Health Care
Who cites it
83 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- A Systematic Review to Summarize and Critically Appraise Existing Phenotype Libraries Using Electronic Health Records.Pharmacoepidemiology and drug safety · 2026Pooled it
- Framework for the synthesis of non-randomised studies and randomised controlled trials: a guidance on conducting a systematic review and meta-analysis for healthcare decision making.BMJ evidence-based medicine · 2022Pooled it
- The Role of Real-World Evidence in FDA-Approved New Drug and Biologics License Applications.Clinical pharmacology and therapeutics · 2022Pooled it
- Quality of reporting of drug exposure in pharmacoepidemiological studies.Pharmacoepidemiology and drug safety · 2020Pooled it
- The replicability of real-world evidence for the surgical treatment of proximal humeral fractures in older patients evaluated using sceptical p-value.Scientific reports · 2026Observational
- A Comprehensive Mapping of Real-World Studies and Data Sources for Oncology in China: Insights into Landscape, Challenges, and Future Direction.Oncology and therapy · 2026Review
- Drug exposure definitions reported in real-world evidence studies on oncology medicines in patients with colorectal cancer: a scoping review.ESMO real world data and digital oncology · 2026Review
- Investigating respiratory infection as a post-COVID-19 condition using a large passive surveillance cohort from Track PCC.BMC infectious diseases · 2026Article
- Identifying the Initiation of a New Line of Therapy for Metastatic Lung, Breast, and Colorectal Cancer in Real-World Data: A Scoping Review.Pharmacoepidemiology and drug safety · 2026Article
- Value of Clinical Evidence and Health Economics and Outcomes Research (HEOR) Studies.Muscle & nerve · 2026Review
- A scoping review of real-world evidence generation methods to estimate the safety of type 2 diabetes medications on fracture risk.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026Article
- Semaglutide use linked to lower COVID-19 and influenza severity with better renal outcomes after pandemic or seasonal infection.Biology methods & protocols · 2026Article
- Integrating clinical decision support systems, nursing vigilance, and physician prescribing patterns to reduce preventable adverse drug events: a structured evidence-based narrative review on human-AI interface in medication safety.Frontiers in digital health · 2026Review
- Impact of Age on Lipid-Lowering Therapy Prescriptions and LDL-Cholesterol Control: Insights from the PORTRAIT-DYS Study.Global heart · 2026Article
- Association of early cardiac rehabilitation on mortality in patients with dilated cardiomyopathy using national inpatient database.Scientific reports · 2025Article
- First-line cyclin-dependent kinase 4 and 6 inhibitors in combination with an aromatase inhibitor for HR+/HER2- metastatic breast cancer: A real-world cost-effectiveness assessment in a US Medicare-eligible population.Journal of managed care & specialty pharmacy · 2025Article
- Assessing the replicability of RCTs in RWE emulations.BMC medical research methodology · 2025Article
- A Scalable Approach to Assess the Safety of Recently Marketed Systemic Treatments for Atopic Dermatitis in Clinical Practice: First Analysis Cycle of a Sequential Monitoring System.The Journal of investigative dermatology · 2025Article
- Article
- Real-world data to support post-market safety and performance of embolization coils: evidence generation from a medical device manufacturer and data institute partnership.BMC medical informatics and decision making · 2024Article
23 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
- Erratum issuedErratum.2017
Authors and funding
15 authors.
Funding
Abstract
purposeDefining a study population and creating an analytic dataset from longitudinal healthcare databases involves many decisions. Our objective was to catalogue scientific decisions underpinning study execution that should be reported to facilitate replication and enable assessment of validity of studies conducted in large healthcare databases.
methodsWe reviewed key investigator decisions required to operate a sample of macros and software tools designed to create and analyze analytic cohorts from longitudinal streams of healthcare data. A panel of academic, regulatory, and industry experts in healthcare database analytics discussed and added to this list.
conclusionEvidence generated from large healthcare encounter and reimbursement databases is increasingly being sought by decision-makers. Varied terminology is used around the world for the same concepts. Agreeing on terminology and which parameters from a large catalogue are the most essential to report for replicable research would improve transparency and facilitate assessment of validity. At a minimum, reporting for a database study should provide clarity regarding operational definitions for key temporal anchors and their relation to each other when creating the analytic dataset, accompanied by an attrition table and a design diagram. A substantial improvement in reproducibility, rigor and confidence in real world evidence generated from healthcare databases could be achieved with greater transparency about operational study parameters used to create analytic datasets from longitudinal healthcare databases.
Indexed as
Identifiers
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.