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

Michelle E Kho, Mark Duffett, Donald J Willison, Deborah J Cook, Melissa C Brouwers, Michelle E Kho, Mark Duffett, Donald J Willison, Deborah J Cook, Melissa C Brouwers

Abstract

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

Design: Systematic review.

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

Study selection: 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.

Data extraction: 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.

Conflict of interest statement

Competing interests: None declared.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4787594/bin/khom601724.f1_default.jpg
Flow diagram of included studies. *Two separate publications reported different outcomes from same studyw18 w19

References

    1. O’Herrin JK, Fost N, Kudsk KA. Health Insurance Portability Accountability Act (HIPAA) regulations: effect on medical record research. Ann Surg 2004;239:772-6; discussion 776-8.
    1. Gordis L, Gold E, Seltser R. Privacy protection in epidemiologic and medical research: a challenge and a responsibility. Am J Epidemiol 1977;105:163-8.
    1. Gershon AS, Tu JV. The effect of privacy legislation on observational research. CMAJ 2008;178:871-3.
    1. Junghans C, Jones M. Consent bias in research: how to avoid it. Heart 2007;93:1024-5.
    1. Kalra D, Gertz R, Singleton P, Inskip HM. Confidentiality of personal health information used for research. BMJ 2006;333:196-8.
    1. Mansbach M, Acholonu U, Clark S, Camargo CA. Variation in institutional review board responses to a standard, observational, pediatric research protocol. Acad Emerg Med 2007;14:377-80.
    1. Stang A, Ahrens W, Jockel K. Control response proportions in population-based case-control studies in Germany. Epidemiology 1999;10:181-3.
    1. Guyatt GH, Rennie D, eds. Users’ guides to the medical literature: a manual for evidence-based clinical practice. Chicago: AMA Press, 2002.
    1. Hatala R, Keitz S, Wyer P, Guyatt G, for the Evidence-Based Medicine Teaching Tips Working Group. Tips for learners of evidence-based medicine: 4. Assessing heterogeneity of primary studies in systematic reviews and whether to combine their results. CMAJ 2005;172:661-5.
    1. Moher D, Jadad AR, Klassen TP. Guides for reading and interpreting systematic reviews. III. How did the authors synthesize the data and make their conclusions? Arch Pediatr Adolesc Med 1988;152:915-20.
    1. Norman GR, Streiner DL. Biostatistics: the bare essentials. 2nd edn. Hamilton: BC Decker, 2000.
    1. Cook DJ, Sackett DL, Spitzer WO. Methodologic guidelines for systematic reviews of randomized control trials in health care from the Potsdam Consultation on Meta-Analysis. J Clin Epidemiol 1995;48:167-71.
    1. Harris T, Cook DG, Victor C, Rink E, Mann AH, Shah S, et al. Predictors of depressive symptoms in older people—a survey of two general practice populations. Age Ageing 2003;32:501-8.
    1. Willison DJ, Kapral MK, Peladeau P, Richards JA, Fang J, Silver FL. Variation in recruitment across sites in a consent-based clinical data registry: lessons from the Canadian Stroke Network. BMC Med Ethics 2006;7:6.
    1. Tooth L, Ware R, Bain C, Purdie DM, Dobson A. Quality of reporting of observational longitudinal research. Am J Epidemiol 2005;161:280-8.
    1. National Health Service Act 2006. 2008. .
    1. HIPAA Privacy Rule: information for researchers, 2006. .
    1. Canadian Institutes for Health Research. Canadian Institutes for health research best practices for protecting privacy in health research. Ottawa: CIHR, 2005.
    1. Directive 2002/58/EC of the European Parliament and of the Council of 12 Jul 2002. 2008. .
    1. Suarez-Almazor ME, Belseck E, Homik J, Dorgan M, Ramos-Remus C. Identifying clinical trials in the medical literature with electronic databases: MEDLINE alone is not enough. Control Clin Trials 2000;21:476-87.

Source: PubMed

스폰서 및 공동 작업자

건강 상태

약물 개입

3
구독하다