ReviewPharmacoepidemiology and drug safety2021
New-user and prevalent-user designs and the definition of study time origin in pharmacoepidemiology: A review of reporting practices.
Review 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 25 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
25 citing papers in PubMed.
- Trial
- Evaluation of Time-related Bias With Non-user Control.Journal of epidemiology · 2026Article
- An operational target trial emulation framework for causal inference using electronic health record data.NPJ digital medicine · 2026Review
- Outcomes of oral antidiabetic drugs in metabolic dysfunction-associated steatotic liver disease: a nationwide target trial emulation study.Clinical and molecular hepatology · 2026Article
- Association Between Sodium-Glucose Cotransporter-2 Inhibitors and Sepsis Risk in Patients With Type 2 Diabetes Mellitus.Journal of diabetes research · 2026Article
- Identifying and avoiding design related biases in observational studies using the target trial framework.BMJ medicine · 2026Article
- Adverse Drug Events Associated with Opioid Treatment for Pain After Motor Vehicle Crash.Journal of pain research · 2026Article
- Impact of Washout Duration to Account for Left Truncation in Register-based Epidemiologic Studies: Estimating the Risk of Mental Disorders.Epidemiology (Cambridge, Mass.) · 2025Article
- Risk of suicidal ideation and suicidality among adults prescribed semaglutide for weight management: A population-based cohort study.Diabetes, obesity & metabolism · 2025Article
- Impact of pooled procurement of medicines on patient adherence and economic burden: evidence from China.Journal of global health · 2025Article
- Association Between Sex and Recent Pregnancy and Hepatitis C Virus Treatment in People With Opioid Use Disorder.O&G open · 2025Article
- Group-based trajectory modeling to assess adherence to chronic urate-lowering therapies among commercially insured US adults with gout.Journal of managed care & specialty pharmacy · 2025Article
- Cautious interpretation of the findings of no increasing risk of breast cancer in users of calcium channel blockers from the population-based cohort study in Taiwan.Hypertension research : official journal of the Japanese Society of Hypertension · 2025Article
- Association Between Oral Anticoagulant Adherence and Serious Clinical Outcomes in Patients With Atrial Fibrillation: A Long-Term Retrospective Cohort Study.Journal of the American Heart Association · 2024Observational
- Safety of SGLT2 inhibitors, DPP-4 inhibitors, and GLP-1 receptor agonists in US veterans with and without chronic kidney disease: a population-based study.Lancet regional health. Americas · 2024Article
- The Assessment of the Association of Proton Pump Inhibitor Usage with Chronic Kidney Disease Progression through a Process Mining Approach.Biomedicines · 2024Article
- Adherence, health care utilization, and costs between long-acting injectable and oral antipsychotic medications in South Carolina Medicaid beneficiaries with schizophrenia.Journal of managed care & specialty pharmacy · 2024Article
- Long-term benefits of dapagliflozin on renal outcomes of type 2 diabetes under routine care: a comparative effectiveness study on propensity score matched cohorts at low renal risk.The Lancet regional health. Europe · 2024Article
- Implications of Mean Pulmonary Arterial Wedge Pressure Trajectories in Pulmonary Arterial Hypertension.American journal of respiratory and critical care medicine · 2024Article
- Use of non-specific immunoglobulins in Catalonia in three third-level hospitals: a descriptive analysis of a hospital-prescribed medication registry.Frontiers in pharmacology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundGuidance reports for observational comparative effectiveness and drug safety research recommend implementing a new-user design whenever possible, since it reduces the risk of selection bias in exposure effect estimation compared to a prevalent-user design. The uptake of this guidance has not been studied extensively.
methodsWe reviewed 89 observational effectiveness and safety cohort studies published in six pharmacoepidemiological journals in 2018 and 2019. We developed an extraction tool to assess how frequently new-user and prevalent-user designs were reported to be implemented. For studies that implemented a new-user design in both treatment arms, we extracted information about the extent to which the moment of meeting eligibility criteria, treatment initiation, and start of follow-up were reported to be aligned.
resultsOf the 89 studies included, 40% reported implementing a new-user design for both the study exposure arm and the comparator arm, while 13% reported implementing a prevalent-user design in both arms. The moment of meeting eligibility criteria, treatment initiation, and start of follow-up were reported to be aligned in both treatment arms in 53% of studies that reported implementing a new-user design. We provided examples of studies that minimized the risk of introducing bias due to unclear definition of time origin in unexposed participants, immortal time, or a time lag.
conclusionsAlmost half of the included studies reported implementing a new-user design. Implications of misalignment of study design origin were difficult to assess because it would require explicit reporting of the target estimand in original studies. We recommend that the choice for a particular study time origin is explicitly motivated to enable assessment of validity of the study.
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.