Evidence map›Paper›PMID 30871502›Full record

ArticleBMC medical research methodology2019

Bias in pharmacoepidemiologic studies using secondary health care databases: a scoping review.

Guillermo Prada-Ramallal, Bahi Takkouche, Adolfo Figueiras

Abstract readScoping Review
In one paragraph

Article in BMC medical research methodology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 74 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 6 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
  2. Chemoprevention of Barrett's Esophagus: a Systematic Review and Comprehensive Assessment of Bias.Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus · 2025
    Pooled it
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  5. Methodological evaluation of bias in observational coronavirus disease 2019 studies on drug effectiveness.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2021
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  10. 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 · 2026
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14 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Guillermo Prada-RamallalDepartment of Preventive Medicine and Public Health, University of Santiago de Compostela, c/ San Francisco s/n, 15786, Santiago de Compostela, A Coruña, Spain.
Bahi TakkoucheDepartment of Preventive Medicine and Public Health, University of Santiago de Compostela, c/ San Francisco s/n, 15786, Santiago de Compostela, A Coruña, Spain.
Adolfo FigueirasDepartment of Preventive Medicine and Public Health, University of Santiago de Compostela, c/ San Francisco s/n, 15786, Santiago de Compostela, A Coruña, Spain. adolfo.figueiras@usc.es.ORCID 0000-0002-5766-8672

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe availability of clinical and therapeutic data drawn from medical records and administrative databases has entailed new opportunities for clinical and epidemiologic research. However, these databases present inherent limitations which may render them prone to new biases. We aimed to conduct a structured review of biases specific to observational clinical studies based on secondary databases, and to propose strategies for the mitigation of those biases.

methodsScoping review of the scientific literature published during the period 2000-2018 through an automated search of MEDLINE, EMBASE and Web of Science, supplemented with manually cross-checking of reference lists. We included opinion essays, methodological reviews, analyses or simulation studies, as well as letters to the editor or retractions, the principal objective of which was to highlight the existence of some type of bias in pharmacoepidemiologic studies using secondary databases.

resultsA total of 117 articles were included. An increasing trend in the number of publications concerning the potential limitations of secondary databases was observed over time and across medical research disciplines. Confounding was the most reported category of bias (63.2% of articles), followed by selection and measurement biases (47.0% and 46.2% respectively). Confounding by indication (32.5%), unmeasured/residual confounding (28.2%), outcome misclassification (28.2%) and "immortal time" bias (25.6%) were the subcategories most frequently mentioned.

conclusionsSuboptimal use of secondary databases in pharmacoepidemiologic studies has introduced biases in the studies, which may have led to erroneous conclusions. Methods to mitigate biases are available and must be considered in the design, analysis and interpretation phases of studies using these data sources.

Indexed as

BiasBiomedical ResearchDatabases, FactualDelivery of Health CareHealth PolicyHealth ServicesHumansInformation Storage and RetrievalMedical InformaticsPharmacoepidemiologyAdministrative claimsBiasConfounding factorsElectronic health recordsMedical record linkageMedical recordsObservational studiesPharmacoepidemiology

Identifiers

PMID30871502
PMCPMC6419460

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.