Health literacy predicts participant understanding of orally-presented informed consent information.

Raymond L Ownby,Amarilis Acevedo,Kenneth Goodman,Joshua Caballero,Drenna Waldrop-Valverde

doi:10.15761/crt.1000105

Abstract

Informed consent for participation in studies with human subjects is a critically important aspect of clinical research, but research has shown that many potential subjects do not understand information relevant to their participation. A better understanding of factors related to participant understanding of study-related information is thus important. As part of a study to develop a new measure of health literacy, participants viewed a 50 second video in their preferred language (Spanish or English) of a clinician presenting informed consent information. They then responded to six questions about it. In progressively more complicated regression models, we evaluated the relation of demographic variables, general cognitive ability, and health literacy to participants’ recall of the information. In a model that only included demographic variables, Spanish language, black race and older age were associated with poorer performance. In a model that included the effects of general cognitive ability and health literacy as well as demographics, education and health literacy were related to performance. Informed consent interventions that take potential research subjects’ levels of health literacy into account may result in better understanding of research-related information that can inform their decision to participate.

Highlights

Giving potential research subjects the information they need to make informed choices about participation in clinical studies is a key part of the informed consent process with crucial ethical and practical implications for the conduct of clinical research
These results suggest that understanding what affects participants’ understanding of participation and how they use this understanding to make decisions may be important in improving the informed consent process in clinical research
Results show that most participants were able to recall some specific information relevant to their participation in a clinical study but that their recall was less than perfect

Summary

Introduction

Giving potential research subjects the information they need to make informed choices about participation in clinical studies is a key part of the informed consent process with crucial ethical and practical implications for the conduct of clinical research. Findings among research subjects are mirrored by findings on patients’ understanding of informed consent information related to medical treatment [8,9,10] and on information provided by clinicians during regular clinical encounters [11] These results suggest that understanding what affects participants’ understanding of participation and how they use this understanding to make decisions may be important in improving the informed consent process in clinical research. Lower levels of health literacy have been related to health service utilization, lower adherence to treatment recommendations, and poorer health-related quality of life [13,14,15] They have even been related to increased risk of mortality [16,17,18]

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Results

Conclusion