ArticleBMC medicine2021
Risk of bias in observational studies using routinely collected data of comparative effectiveness research: a meta-research study.
Article in BMC medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 7 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
37 citing papers in PubMed, 7 syntheses or guidelines pooled it.
- Identifying, handling and impact of immortal time bias on addressing treatment effects in observational studies using routinely collected data.BMC medical research methodology · 2025Pooled it
- The Association Between Nut Consumption and Risk of Depressive Symptoms: A Meta-Analysis of Observational Studies.Nutrients · 2025Pooled it
- Methodological challenges using routine clinical care data for real-world evidence: a rapid review utilizing a systematic literature search and focus group discussion.BMC medical research methodology · 2025Pooled it
- Conducting observational analyses with the target trial emulation approach: a methodological systematic review.BMJ open · 2024Pooled it
- Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials: A Systematic Review.JAMA network open · 2023Pooled it
- Data source profile reporting by studies that use routinely collected health data to explore the effects of drug treatment.BMC medical research methodology · 2023Pooled it
- Real-World Use of Symptomatic Treatments in Early Alzheimer's Disease.Journal of Alzheimer's disease : JAD · 2023Pooled it
- A Real-World Target Trial Emulation of Eteplirsen, Casimersen, and Golodirsen to Evaluate Survival Among Patients with Duchenne Muscular Dystrophy.Advances in therapy · 2026Article
- Target trial emulation: A practical framework for credible real-world evidence of healthcare interventions.Chinese medical journal · 2026Article
- Review
- Propensity score matching assessment of direct medical charges for patients with healthcare-associated infections.Frontiers in public health · 2026Article
- Methodological guidance on implementing propensity score matching in observational studies of kidney transplantation.Scientific reports · 2025Article
- Association of Long-Term Oral β-Blocker Use With Cardiac Troponin I and B-Type Natriuretic Peptide in Septic Myocardial Injury: A Retrospective Cohort Study.Health science reports · 2025Article
- A systematic review and meta-analysis to identify vertical limits for a high-dose opioid therapy.Neurological research and practice · 2025Review
- Aortic valve replacement and mortality in asymptomatic individuals with severe aortic stenosis and left ventricular hypertrophy.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2025Article
- OPTIMAL PAO 2 IS 130-160 MMHG IN THE FIRST WEEK FOR SEPSIS PATIENTS IN ICU: A RETROSPECTIVE COHORT STUDY BASED ON MIMIC-IV DATABASE.Shock (Augusta, Ga.) · 2025Article
- Causal associations between dietary habits and liver cancer risk: a two-sample Mendelian randomization study.Discover oncology · 2025Article
- Celiac Disease and Skin Diseases: A Bidirectional Mendelian Randomization Study.Clinical, cosmetic and investigational dermatology · 2025Article
- How life-cycle real-world evidence can bridge evidentiary gaps in precision oncology.Frontiers in medicine · 2025Article
- Characteristics and impact of real-world evidence studies in oncology: comprehensive mapping review of publications evaluating targeted therapies in solid tumours.ESMO real world data and digital oncology · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTo assess the completeness of reporting, research transparency practices, and risk of selection and immortal bias in observational studies using routinely collected data for comparative effectiveness research.
methodWe performed a meta-research study by searching PubMed for comparative effectiveness observational studies evaluating therapeutic interventions using routinely collected data published in high impact factor journals from 01/06/2018 to 30/06/2020. We assessed the reporting of the study design (i.e., eligibility, treatment assignment, and the start of follow-up). The risk of selection bias and immortal time bias was determined by assessing if the time of eligibility, the treatment assignment, and the start of follow-up were synchronized to mimic the randomization following the target trial emulation framework.
resultSeventy-seven articles were identified. Most studies evaluated pharmacological treatments (69%) with a median sample size of 24,000 individuals. In total, 20% of articles inadequately reported essential information of the study design. One-third of the articles (n = 25, 33%) raised some concerns because of unclear reporting (n = 6, 8%) or were at high risk of selection bias and/or immortal time bias (n = 19, 25%). Only five articles (25%) described a solution to mitigate these biases. Six articles (31%) discussed these biases in the limitations section.
conclusionReporting of essential information of study design in observational studies remained suboptimal. Selection bias and immortal time bias were common methodological issues that researchers and physicians should be aware of when interpreting the results of observational studies using routinely collected data.
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.