The effectiveness of health literacy interventions on the informed consent process of health care users: a systematic review protocol.

Abstract

REVIEW QUESTION / OBJECTIVE The aim of this systematic review is to establish the best available evidence of the effectiveness of health literacy interventions on the informed consent process for health care users. The specific review question is: What is the effectiveness of health literacy interventions on health care users' informed consent to health procedures processes? INCLUSION CRITERIA Types of participants This review will consider all studies that include adults (18 years or over) receiving care or adults who are proxies of incompetent health care users or of children (parents or guardians) who have been actively involved in an informed consent process regarding health care procedures. Participants may be healthy or may have any kind of physical disability, be recruited in any type of health care environment, including acute (hospital), primary care, psychiatric and aged care, in any health specialty, including medicine, dentistry and pharmacy. Studies whose participants have cognitive impairment will be excluded. Studies on informed consent processes for research participants will be also excluded. Types of intervention(s) The interventions, methods, and strategies will be included if: - they aim to improve the informed consent process related to health issues among health care users or their proxies, - they are designed taking into consideration health literacy as a main concept, and - the intervention is provided by any health care provider. Such interventions my focus on either the material provided (e.g. readability, processability), or the supportive procedure of informed consent (e.g. video) in order to decrease the health literacy TRUNCATED AT 250 WORDS