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J Clin Epidemiol. 2012 Jul;65(7):708-24. doi: 10.1016/j.jclinepi.2012.01.004. Epub 2012 Apr 25.

Informed consent documents do not encourage good-quality decision making.

Author information

1
Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital, General Campus, 501 Smyth Road, Centre for Practice-Changing Research, Box 201B, Ottawa, Ontario, Canada K1H 8L6. jbrehaut@ohri.ca

Abstract

OBJECTIVE:

Informed consent for research has emphasized information provision over support to people making a difficult decision. We assessed the extent to which existing informed consent documents (ICDs) conform to the International Patient Decision Aid Standards for supporting decision making.

STUDY DESIGN AND SETTING:

One hundred thirty-nine ICDs for trials registered with ClinicalTrials.gov were obtained from study investigators. Using a four-point scale, two raters assessed each ICD on 32 items.

RESULTS:

Overall agreement between raters was 95.1% (linear weighted kappa-0.745). For 12 items focused on providing enough information, conformity was above 50% for three, and 0% for another four. For all eight items focused on how to present outcome probabilities, conformity was below 20%. For two items focused on clarifying and expressing values, conformity was below 10%. For two items focused on improving structured guidance, conformity was below 5%. For four items focused on using evidence, one item showed conformity of 74%; all others showed conformity below 5%. For four items focused on transparency, conformity was high (above 60% for two, above 80% for the others).

CONCLUSIONS:

Existing ICDs do not meet most validated standards for encouraging good decision making. These standards make clear predictions about how one might improve ICDs ensure that research participants are fully informed.

PMID:
22537428
DOI:
10.1016/j.jclinepi.2012.01.004
[Indexed for MEDLINE]

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