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.
RCT Entities:
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.
Authors: Barbara Resnick; Elizabeth Galik; Marie Boltz; Sarah Holmes; Steven Fix; Erin Vigne; Shijun Zhu; Regina Lewis Journal: Consult Pharm Date: 2018-06-01
Authors: Timothy F Platts-Mills; Joseph A Dayaa; Bryce B Reeve; Kayla Krajick; Laura Mosqueda; Jason S Haukoos; Mehul D Patel; Carrie F Mulford; Samuel A McLean; Phil D Sloane; Debbie Travers; Sheryl Zimmerman Journal: J Elder Abuse Negl Date: 2018-04-13
Authors: Barbara Resnick; Elizabeth Galik; Marie Boltz; Sarah Holmes; Steven Fix; Regina Lewis; Erin Vigne Journal: Clin Nurs Res Date: 2018-06-27 Impact factor: 2.075
Authors: Andrew M McMillan; Karl B Landorf; Mark F Gilheany; Adam R Bird; Adam D Morrow; Hylton B Menz Journal: J Foot Ankle Res Date: 2010-07-16 Impact factor: 2.303