Written informed consent and selection bias in observational studies using medical records: systematic review.
OBJECTIVE
To determine whether informed consent introduces selection bias in prospective observational studies using data from medical records, and consent rates for such studies.


METHODS
Systematic review.


METHODS
Embase, Medline, and the Cochrane Library up to March 2008, reference lists from pertinent articles, and searches of electronic citations.


METHODS
Prospective observational studies reporting characteristics of participants and non-participants approached for informed consent to use their medical records. Studies were selected independently in duplicate; a third reviewer resolved disagreements.


METHODS
Age, sex, race, education, income, or health status of participants and non-participants, the participation rate in each study, and susceptibility of these calculations to threats of selection and reporting bias.


RESULTS
Of 1650 citations 17 unique studies met inclusion criteria and had analysable data. Across all outcomes there were differences between participants and non-participants; however, there was a lack of consistency in the direction and the magnitude of effect. Of 161 604 eligible patients, 66.9% consented to use of data from their medical records.


CONCLUSIONS
Significant differences between participants and non-participants may threaten the validity of results from observational studies that require consent for use of data from medical records. To ensure that legislation on privacy does not unduly bias observational studies using medical records, thoughtful decision making by research ethics boards on the need for mandatory consent is necessary.
Kho
Michelle E
ME
Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main Street West, Hamilton, ON, Canada L8S 4L8. khome@mcmaster.ca
Duffett
Mark
M
Willison
Donald J
DJ
Cook
Deborah J
DJ
Brouwers
Melissa C
MC
D006801:Humans; D007258:Informed Consent / Q000706:statistics & numerical data*; D008499:Medical Records / Q000706:statistics & numerical data*; D012107:Research Design; D015983:Selection Bias