ArticleJournal of clinical epidemiology2022
Controversy and Debate: Questionable utility of the relative risk in clinical research: Paper 1: A call for change to practice.
Article in Journal of clinical epidemiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 67 papers, 25 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
67 citing papers in PubMed, 25 syntheses or guidelines pooled it.
- Reassessing the adverse event profiles of levetiracetam and brivaracetam: a systematic review and meta-analysis.Journal of neurology · 2026Pooled it
- Comparative Efficacy and Acceptability of Treatment Strategies for Antipsychotic-Induced Akathisia: A Systematic Review and Network Meta-analysis.Schizophrenia bulletin · 2026Pooled it
- Metformin safety during pregnancy in women with gestational diabetes mellitus: A systematic review and meta-analysis of maternal, neonatal and long-term outcomes.Diabetic medicine : a journal of the British Diabetic Association · 2026Pooled it
- Impact of Short-Term Exposure to Ozone on Hospital Admissions for Multiple Cardiovascular Diseases: A Systematic Review and Meta-Analysis.Journal of the American Heart Association · 2025Pooled it
- Postmastectomy Breast Reconstruction in Patients with Non-Metastatic Breast Cancer: A Systematic Review.Current oncology (Toronto, Ont.) · 2025Pooled it
- Initial treatment choices for long-term remission of chronic insomnia disorder in adults: a systematic review and network meta-analysis.Psychiatry and clinical neurosciences · 2024Pooled it
- Time Gained to Cardiovascular Disease by Intensive Lipid-Lowering Therapy: Results of Individual Placebo-Controlled Trials and Pooled Effects.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2024Pooled it
- Community-based exercises improve health status in pre-frail older adults: A systematic review with meta-analysis.BMC geriatrics · 2024Pooled it
- Psychiatric Adverse Events of Acetylcholinesterase Inhibitors in Alzheimer's Disease and Parkinson's Dementia: Systematic Review and Meta-Analysis.Drugs & aging · 2023Pooled it
- The normality assumption on between-study random effects was questionable in a considerable number of Cochrane meta-analyses.BMC medicine · 2023Pooled it
- Pooled it
- Interventions for promoting evidence-based guideline-consistent surgery in low back pain: a systematic review and meta-analysis of randomised controlled trials.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2022Pooled it
- Synthesizing evidence from the earliest studies to support decision-making: To what extent could the evidence be reliable?Research synthesis methods · 2022Pooled it
- Colchicine linked with risk reduction for myocardial infarction in gout patients: systematic review and meta-analysis.Zeitschrift fur Rheumatologie · 2022Pooled it
- Anticoagulants for thrombosis prophylaxis in acutely ill patients admitted to hospital: systematic review and network meta-analysis.BMJ (Clinical research ed.) · 2022Pooled it
- The prevalence of adaptive immunity to COVID-19 and reinfection after recovery - a comprehensive systematic review and meta-analysis.Pathogens and global health · 2022Pooled it
- Pharmacological and dietary-supplement treatments for autism spectrum disorder: a systematic review and network meta-analysis.Molecular autism · 2022Pooled it
- Mortality Rates Among Hospitalized Patients With COVID-19 Infection Treated With Tocilizumab and Corticosteroids: A Bayesian Reanalysis of a Previous Meta-analysis.JAMA network open · 2022Pooled it
- Controversy and Debate : Questionable utility of the relative risk in clinical research: Paper 4 :Odds Ratios are far from "portable" - A call to use realistic models for effect variation in meta-analysis.Journal of clinical epidemiology · 2022Pooled it
- Controversy and Debate: Questionable utility of the relative risk in clinical research: Paper 2: Is the Odds Ratio "portable" in meta-analysis? Time to consider bivariate generalized linear mixed model.Journal of clinical epidemiology · 2022Pooled it
7 more citing papers are in PubMed but not listed here.
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesIn clinical trials, the relative risk or risk ratio (RR) is a mainstay of reporting of the effect magnitude for an intervention. The RR is the ratio of the probability of an outcome in an intervention group to its probability in a control group. Thus, the RR provides a measure of change in the likelihood of an event linked to a given intervention. This measure has been widely used because it is today considered a measure with "portability" across varying outcome prevalence, especially when the outcome is rare. It turns out, however, that there is a much more important problem with this ratio, and this paper aims to demonstrate this problem.
methodsWe used mathematical derivation to determine if the RR is a measure of effect magnitude alone (i.e., a larger absolute value always indicating a stronger effect) or not. We also used the same derivation to determine its relationship to the prevalence of an outcome. We confirm the derivation results with a follow-up analysis of 140,620 trials scraped from the Cochrane.
resultsWe demonstrate that the RR varies for reasons other than the magnitude of the effect because it is a ratio of two posterior probabilities, both of which are dependent on baseline prevalence of an outcome. In addition, we demonstrate that the RR shifts toward its null value with increasing outcome prevalence. The shift toward the null happens regardless of the strength of the association between intervention and outcome. The odds ratio (OR), the other commonly used ratio, measures solely the effect magnitude and has no relationship to the prevalence of an outcome in a study nor does it overestimate the RR as is commonly thought.
conclusionsThe results demonstrate the need to (1) end the primary use of the RR in clinical trials and meta-analyses as its direct interpretation is not meaningful, (2) replace the RR by the OR, and (3) only use the postintervention risk recalculated from the OR for any expected level of baseline risk in absolute terms for purposes of interpretation such as the number needed to treat. These results will have far-reaching implications such as reducing misleading results from clinical trials and meta-analyses and ushering in a new era in the reporting of such trials or meta-analyses in practice.
Indexed as
Identifiers
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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.