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Synapse
March 12, 2009BMJ282 citationsOpen Access

Written informed consent and selection bias in observational studies using medical records: systematic review

MKMichelle E. KhoMDMark DuffettDWDonald J. Willison

Key Points

  • Assess how mandatory written informed consent requirements introduce selection bias and affect the validity of observational studies relying on medical records.
  • Systematic review evaluating observational studies utilizing medical records that required participant consent.
  • Significant differences exist between individuals who provide consent and those who do not.
  • Mandatory consent policies systematically threaten the internal and external validity of observational health database research by skewing study populations.

Abstract

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.

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Cite This Study

Kho et al. (2009) studied this question.

synapsesocial.com/papers/69def84292a5e9426ae93fc4https://doi.org/10.1136/bmj.b866
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