Capacity to Consent to Research in Patients with Acute Pain: A Pilot Study

Size: px

Start display at page:

Download "Capacity to Consent to Research in Patients with Acute Pain: A Pilot Study"

Isaac Small
5 years ago
Views:

1 FEATURE ARTICLE Capacity to Consent to Research in Patients with Acute Pain: A Pilot Study by Ethan Cowan, Hadassa Klerman, and Jeffrey Ma Table 1. MacCAT-CR Questions and Possible Scores UNDERSTANDING SUBSCALE (total possible score = 26) The individual understands that the purpose of the project is to compare PCA to standard care (2) how long the project will last (2) what is going to be measured (verbal pain ratings and side effects, vital signs) (2) how often measurements will be taken (2) that the main goal is to see if PCA works better than routine care (2) what the control and experimental groups will receive (2) that the treatment will be randomized (2) that the amount of pain medications given will vary based on assigned group (2) what doctors might learn from the research societal benefit (2) how being in the study could benefit him or her personal benefit (2) what some potential side effects of morphine are (2) what might happen to people s pain if they enroll in the study (2) what will happen if a person refuses to be in the research project or decides to stop once it begins (2) APPRECIATION SUBSCALE (total possible score = 6) The individual appreciates that personal benefit is not the primary objective (2) there is a possibility of reduced benefit by being in the study (2) the decision to withdraw will be honored (2) REASONING SUBSCALE (total possible score = 6) The individual is able to describe consequences of participating in the study (2) describe the merits of his or her decision on whether to participate (2) express a choice that is consistent with described consequences (2) EXPRESSING A CHOICE (total possible score = 2) The individual is able to make a choice about whether to participate in the study. (2) IRB: Ethics & Human Research may-june

2 Table 2. Characteristics of Individuals Who Enrolled or Refused to Participate Characteristics Enrolled Refused/Withdrew P-value N = 34 N = 19 Age Male Race/Ethnicity Spanish/Hispanic/Latino African American/Black Caucasian Other Grade Level Achieved 0-8th grade Some high school High-school diploma Beyond high school Insurance Status Public Private Uninsured Employed Family Income Less than 20K 20K to 50K More than 50K Triage Pain Score 37.3 ± % 53% (18/34) 29% (10/34) 12% (4/34) 6% (2/34) 3% (1/34) 18% (6/34) 15% (5/34) 65% (22/34) 58% (18/31) 16% (5/31) 26% (8/31) 50% (17/34) 53% (17/32) 31% (10/32) 16% (5/32) 7.1 ± ± % % (7/19) 42% (8/19) % (3/19) 26% (5/19) % (3/19) 53% (10/19) 74% (14/19) 21% (4/19) % % (11/17) 35% (6/17) % (0/17) 6.7 ± Continuous variables are reported as mean values (standard deviation), and categorical variables are reported as percentages (n/n). Denominators vary due to missing data. 2 May-June 2015 IRB: Ethics & Human Research

3 Table 3. Pearson s r for MacCAT-CR Subscales, Triage Pain Score, and Sociodemographic Variables Triage Pain Source Age Gender Race/ Ethnicity Education Insurance Status Employment Status Understanding Appreciation Income Reasoning * 0.45* Expressing a Choice *p < 0.05 Please see page 4 for Figure 1. Mac-CAT-CR Subscale Scores, and page 5 for Figure 2. Scatterplots with 95% Confidence Intervals of MacCAT-CR Subscale Scores and Triage Pain Scores. IRB: Ethics & Human Research may-june

4 MacCAT-CR Subscale Score Figure 1. MacCAT-CR Subscale Scores Understanding (Range 0-26) Appreciation (Range 0-6) Reasoning (Range 0-6) Expressing a Choice (Range 0-2) Box and whisker plot of MacCAT-CR subscale scores. The solid line inside the box represents the median score. The box represents all scores falling in between the lower and upper quartiles. Whiskers represent the range of scores from upper to lower extreme. The solid circles represent outlying values.

5 Figure 2. Scatterplots with 95% Confidence Intervals of MacCAT-CR Subscale Scores and Triage Pain Scores

Enrollment under the Medicaid Expansion and Health Insurance Exchanges. A Focus on Those with Behavioral Health Conditions in Michigan

Enrollment under the Medicaid Expansion and Health Insurance Exchanges A Focus on Those with Behavioral Health Conditions in Michigan Methods for Estimating Uninsured with M/SU Conditions by FPL From NSDUH,