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 346 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.