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Ensuring Safety: Informed Consent for Patients with Limited Health Literacy

As part of its consensus development process, the National Quality Forum (NQF) developed "A National Consensus Standard for Informed Consent: Safe Practice 10." This Commonwealth Fund–supported user's guide brings together the evidence demonstrating the need for better informed consent and the benefits of adopting Safe Practice 10, which is one of 30 practices endorsed by the NQF to improve patient safety throughout the health care system. The objective of Safe Practice 10 is "to ensure that patients or their legal surrogates understand proposed treatments and their potential complications." In addition, the user's guide gives health care providers and administrators the information and tools they need to implement Safe Practice 10 in their organizations.

The Issue: A patient's informed consent is required for medical treatment, including surgical procedures. But millions of Americans—particularly those with low health literacy—have difficulty comprehending medical information and physician instructions. (Those most likely to have low health literacy are people with limited English proficiency (LEP), cognitive impairments, learning disabilities, and low educational attainment, as well as the poor, the elderly, and some minority groups.)

Studies have shown that, even though patients may sign a form agreeing to a particular procedure, they may be unable to recall the risks of the procedure or answer basic questions about it. Because of poor physician communication, jargon-laden forms, unfamiliarity with medical terms, learning disabilities, visual impairments, language barriers, or other reasons, patients may not be able to read or understand consent forms, or physicians' explanations about them. Thus, they may not be truly able to give their informed consent for medical procedures such as surgery.

Ensuring that patients understand medical treatments can improve patient safety and strengthen provider–patient relationships. To help ensure patients' safety and meaningful participation in health care decisions, the National Quality Forum (NQF) has recommended that health care providers ask patients to recount what they believe they have agreed to as a way to confirm that informed consent has indeed been given. "A National Consensus Standard for Informed Consent: Safe Practice 10" is one of 30 voluntary consensus standards endorsed by the National Quality Forum. The NQF recommends that providers use the "teach back" method as part of the informed consent process: Ask each patient or their legal surrogate to recount what he or she has been told during the informed consent discussion.

Additionally, the NQF recommends that consent forms be written in simple sentences in patients' primary language; that providers engage patients in dialogue about the nature and scope of procedures; that patients be offered interpreters or readers as needed; and that providers convey the higher risk associated with suboptimal volumes for certain high-risk procedures.

Organization: National Quality Forum

Target Populations: Providers; health care administrators

The Intervention: Implementing Safe Practice 10 can be challenging, particularly for providers who serve patients with low literacy or limited English proficiency. To facilitate implementation, the NQF created a user's guide for health care professionals. The guide brings together the evidence demonstrating the need for Safe Practice 10 and the benefits of adopting it. It outlines plans of action, with detailed recommended steps following the Plan-Do-Check-Act model. In addition, it offers advice for improving provider–patient communications and reviews the professional, legal, and ethical arguments for ensuring informed consent. In 2004, the NQF evaluated the informed consent process and teach back method as it was put into practice at four hospitals. The guide includes lessons from these case studies, offering evidence of improved safety and risk management, as well as data on costs and efficiency. To order copies of the user's guide, contact [email protected] or download a copy from the NQF web site,

For Further Information: See H.W. Wu, R. Y. Nishimi, C. M. Page-Lopes et al., "Improving Patient Safety through Informed Consent for Patients with Limited Health Literacy: An Implementation Report." National Quality Forum, September 2005. Contact Fatema Salam, M.P.H., program director, National Quality Forum, at [email protected].

March 2006

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