Reliability and validity of the evaluation to sign consent measure

Purpose: The purpose of this report is to evaluate the reliability and validity of the five-item Evaluation to Sign Consent (ESC), a measure that can guide determination of an older adult's capacity to consent for research. Design and Methods: Information was obtained from 3,46 nursing home residents from six facilities who were being enrolled into a randomized controlled trial testing a restorative care intervention. In addition to the ESC, the resident's cognitive status and demographic information was obtained. Results: The average age of the participants was 86.1 +/- 7.3 years; most of the participants were female (84%) and Caucasian (95%). The mean Mini-Mental State Exam score was 18.0 +/- 7.4. A total of 218 residents (63%) did not pass the ESC. According to a Rasch analysis and the inter-rater reliability (r = .81), there was some evidence of reliability and validity with this measure. Logistic regression showed that Items 1 (describing two risks to participation in the study) and 2 (knowing what is associated with participation) had the greatest overall percentage of agreement with the full ESC, and the Mini-Mental State Exam was the only resident-tested variable to predict the results of the ESC. Implications: This study provides useful information about the ESC. It indicates a reason and a method to move beyond cognitive testing that can more appropriately evaluate the capacity to consent to participate in research.