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Informed Consent
One of the first TIPS in the CMPA series of 9 tips to aid physicians in providing quality care while avoiding medico-legal difficulties. This first TIP- "Obtain truly informed consent" emphasizes the need to take medical informed consent seriously. When done well, informed consent allows the physician-patient relationship to become a partnership with shared responsibility for outcomes.
A shared responsibility for outcomes ensures that any potential negative outcomes will be accepted and understood by the patient.
The degree of risk will help you determine the amount of information necessary for the patient to understand. In scenarios with multiple choices of significant risk, the consent must be detailed, thorough and documented. In less complex situations, simple informed consent may be enough. Place the specific risks in the context of the benefits. Quite often, an overemphasis on the risks can raise anxiety and undermine a patient’s confidence in the proposed management plan. In complex situations, this balancing of information is often best done by someone with both up to date knowledge and clinical experience. Please go to the CMPA e-learning module on informed consent. It is highly recommended for a better understanding of the elements of informed consent, age of maturity, documentation of informed consent etc. Using real cases and interactive activities, the real life issues around consent are presented. We were going to summarize the information in the module but found it is too valuable and educational to be missed by all residents and probably faculty too.
Literacy
Frontier College, a Canadian volunteer literacy organization, tells us that 1 in 6 adult Canadians cannot read the newspaper headlines.
Often, in the context of getting informed consent we provide patients with printed information to read about the test or procedure and then ask them to read and sign the consent form. Often these documents are at a very high literacy level and may exclude people who may be reluctant to tell us that they do no understand the materials we have provided. We often have difficult accessing appropriate interpreters for all patient encounters and are unlikely to have print documents available in the language of preference for people whose first language is not english. A recent paper in JAMA[6] suggests that the following questions might help us to identify people with literacy limitations:
We need to use clear language, without medical terminology or jargon, and ensure that print materials are written to, at most, a grade 6 reading level.[8][7]
_________________________________ 6. Powers BJ, Trinh JV, Bosworth HB. Can this patient read and understand written health information? JAMA 2010 Jul 7;304(1):76-84. 7. Paasche-Orlow MK, Taylor HA, and Brancati FL. Readability Standards for Informed-Consent Forms as Compared with Actual Readability. N Engl J Med 2003;348:721-6. accessed September 14, 2010 www.nejm.org/doi/pdf/10.1056/NEJMsa021212 8. Sudore RL, Landefeld CS, Barnes DE, Lindquist K, Williams BA, Brody R, Schillinger D. An advanced directive redesigned to meet the literacy level of most adults: A randomized trial. Patient Educ Couns. 2007 Dec;69(1-3):165-195. |