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. 2023 Apr 22;23(1):98.
doi: 10.1186/s12874-023-01924-6.

Asking informed consent may lead to significant participation bias and suboptimal cardiovascular risk management in learning healthcare systems

Anna G M Zondag  1 , T Katrien J Groenhof  2   3 , Rieke van der Graaf  3 , Wouter W van Solinge  4 , Michiel L Bots  3 , Saskia Haitjema  4 ; UCC-CVRM study group
Collaborators, Affiliations

Asking informed consent may lead to significant participation bias and suboptimal cardiovascular risk management in learning healthcare systems

Anna G M Zondag et al. BMC Med Res Methodol. .

Abstract

Background: The 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.

Methods: All 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.

Results: Out 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.

Conclusions: A 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.

Keywords: CVRM; Cardiovascular diseases; Informed consent; Learning healthcare system; Participation bias.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Sex distribution within age categories across consent groups
Fig. 2
Fig. 2
Sex distribution within treating specialties across consent groups
Fig. 3
Fig. 3
Determinants associated with non-consent compared to consent, including 95% confidence intervals. METmin = metabolic equivalent of task-minutes; CVD = cardiovascular diseases; bpm = beats per minute; HbA1c = glycated haemoglobin; OR = odds ratio indicating the likelihood of having provided a non-consent as compared to a consent; % = percentage
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