ArticleBMC medical research methodology2023
Asking informed consent may lead to significant participation bias and suboptimal cardiovascular risk management in learning healthcare systems.
Article in BMC medical research methodology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed, 8 citations in OpenAlex.
- Dutch-TIMELINESS: optimising choledocholithiasis treatment in the Netherlands - protocol of a national implementation project.BMJ open · 2026Article
- Potential biases associated with reported parental history of dementia in the Alzheimer's Disease Research Center cohorts: Implications for secondary data analyses.Journal of Alzheimer's disease : JAD · 2026Article
- Available guidance for ethical challenges in learning health systems: an integrative literature review.Health research policy and systems · 2026Review
- Dashboards to Improve Extractability of Cardiovascular Indicators in a Learning Health Care System: Mixed Methods Study.Journal of medical Internet research · 2025Article
- Article
- Health disparities and selection bias in obtaining broad consent in a general practitioner setting.Frontiers in medicine · 2025Article
- An assessment of synthetic data generation, use and disclosure under Canadian privacy regulations.AI and ethics · 2025Article
- Bias in obtaining broad consent in a German general practice? - Preliminary results from a cross-sectional study.Journal of family medicine and primary care · 2024Article
- Comparison of the Response to an Electronic Versus a Traditional Informed Consent Procedure in Terms of Clinical Patient Characteristics: Observational Study.Journal of medical Internet research · 2024Observational
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Authors and funding
7 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe Utrecht Cardiovascular Cohort - CardioVascular Risk Management (UCC-CVRM) was set up as a learning healthcare system (LHS), aiming at guideline based cardiovascular risk factor measurement in all patients in routine clinical care. However, not all patients provided informed consent, which may lead to participation bias. We aimed to study participation bias in a LHS by assessing differences in and completeness of cardiovascular risk management (CVRM) indicators in electronic health records (EHRs) of consenting, non-consenting, and non-responding patients, using the UCC-CVRM as an example.
methodsAll patients visiting the University Medical Center Utrecht for first time evaluation of a(n) (a)symptomatic vascular disease or condition were invited to participate. Routine care data was collected in the EHR and an informed consent was asked. Differences in patient characteristics were compared between consent groups. We performed multivariable logistic regression to identify determinants of non-consent. We used multinomial regression for an exploratory analysis for the determinants of non-response. Presence of CVRM indicators were compared between consent groups. A waiver (19/641) was obtained from our ethics committee.
resultsOut of 5730 patients invited, 2378 were consenting, 1907 non-consenting, and 1445 non-responding. Non-consent was related to young and old age, lower education level, lower BMI, physical activity and haemoglobin levels, higher heartrate, cardiovascular disease history and absence of proteinuria. Non-response increased with young and old age, higher education level, physical activity, HbA1c and decreased with lower levels of haemoglobin, BMI, and systolic blood pressure. Presence of CVRM indicators was 5-30% lower in non-consenting patients and even lower in non-responding patients, compared to consenting patients. Non-consent and non-response varied across specialisms.
conclusionsA traditional informed consent procedure in a LHS may lead to participation bias and potentially to suboptimal CVRM, which is detrimental for feedback on findings in a LHS. This underlines the importance of reassessing the informed consent procedure in a LHS.
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