ArticleStatistics in medicine2019
A plea to stop using the case-control design in retrospective database studies.
Article in Statistics in medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
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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.
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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.
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Who cites it
21 citing papers in PubMed.
- Emulating a target trial in case-control designs: an application to statins and colorectal cancer.International journal of epidemiology · 2020Trial
- Assessing the impact of social determinants of health on diabetes severity and management.JAMIA open · 2024Article
- Addressing Cardiovascular Toxicity Risk of Electronic Nicotine Delivery Systems in the Twenty-First Century: "What Are the Tools Needed for the Job?" and "Do We Have Them?"Cardiovascular toxicology · 2024Review
- The State of Use and Utility of Negative Controls in Pharmacoepidemiologic Studies.American journal of epidemiology · 2024Review
- Association between prolactin increasing antipsychotic use and the risk of breast cancer: a retrospective observational cohort study in a United States Medicaid population.Frontiers in oncology · 2024Article
- αInternational journal of molecular sciences · 2023Review
- Thrombosis and thrombocytopenia after vaccination against and infection with SARS-CoV-2 in Catalonia, Spain.Nature communications · 2022Article
- Antipsychotic Medication and Risk of Incident Seizure in People with Autism Spectrum Disorder: Analyses with Cohort and Within Individual Study Designs.Journal of autism and developmental disorders · 2022Article
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- A data-driven pipeline to extract potential adverse drug reactions through prescription, procedures and medical diagnoses analysis: application to a cohort study of 2,010 patients taking hydroxychloroquine with an 11-year follow-up.BMC medical research methodology · 2022Article
- Traumatic Brain Injury and Early Onset Dementia in Post 9-11 Veterans.Brain injury · 2022Article
- Does changing healthcare use signal opportunities for earlier detection of cancer? A review of studies using information from electronic patient records.Cancer epidemiology · 2022Review
- International cohort study indicates no association between alpha-1 blockers and susceptibility to COVID-19 in benign prostatic hyperplasia patients.Frontiers in pharmacology · 2022Article
- Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design.Frontiers in pharmacology · 2022Review
- Introduction to Matching in Case-Control and Cohort Studies.Annals of clinical epidemiology · 2022Article
- The cognitive effect of anticholinergics for patients with overactive bladder.Nature reviews. Urology · 2021Review
- Random control selection for conducting high-throughput adverse drug events screening using large-scale longitudinal health data.CPT: pharmacometrics & systems pharmacology · 2021Article
- Pharmacoepidemiology for nephrologists (part 1): concept, applications and considerations for study design.Clinical kidney journal · 2021Review
- Article
- Considerations for outcome-dependent biased sampling in health databases.Statistics in medicine · 2019Article
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6 authors.
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Abstract
The case-control design is widely used in retrospective database studies, often leading to spectacular findings. However, results of these studies often cannot be replicated, and the advantage of this design over others is questionable. To demonstrate the shortcomings of applications of this design, we replicate two published case-control studies. The first investigates isotretinoin and ulcerative colitis using a simple case-control design. The second focuses on dipeptidyl peptidase-4 inhibitors and acute pancreatitis, using a nested case-control design. We include large sets of negative control exposures (where the true odds ratio is believed to be 1) in both studies. Both replication studies produce effect size estimates consistent with the original studies, but also generate estimates for the negative control exposures showing substantial residual bias. In contrast, applying a self-controlled design to answer the same questions using the same data reveals far less bias. Although the case-control design in general is not at fault, its application in retrospective database studies, where all exposure and covariate data for the entire cohort are available, is unnecessary, as other alternatives such as cohort and self-controlled designs are available. Moreover, by focusing on cases and controls it opens the door to inappropriate comparisons between exposure groups, leading to confounding for which the design has few options to adjust for. We argue that this design should no longer be used in these types of data. At the very least, negative control exposures should be used to prove that the concerns raised here do not apply.
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