TY - JOUR
T1 - Beyond the checklist
T2 - Assessing understanding for HIV vaccine trial participation in South Africa
AU - Lindegger, Graham
AU - Milford, Cecilia
AU - Slack, Catherine
AU - Quayle, Michael
AU - Xaba, Xolani
AU - Vardas, Eftyhia
PY - 2006/12
Y1 - 2006/12
N2 - OBJECTIVES: Informed consent and understanding are essential ethical requirements for clinical trial participation. Traditional binary measures of understanding may be limited and not be the best measures of level of understanding. This study designed and compared 4 measures of understanding for potential participants being prepared for enrollment in South African HIV vaccine trials, using detailed operational scoring criteria. METHODS: Assessment of understanding of 7 key trial components was compared via self-report, checklist, vignettes, and narrative measures. Fifty-nine participants, including members of vaccine preparedness groups and 1 HIV vaccine trial, took part. RESULTS: There were significant differences across the measures for understanding of 5 components and for overall understanding. Highest scores were obtained on self-report and checklist measures, and lowest scores were obtained for vignettes and narrative descriptions. CONCLUSIONS: The findings suggest that levels of measured understanding are dependent on the tools used. Forced-choice measures like checklists tend to yield higher scores than open-ended measures like narratives or vignettes. Consideration should be given to complementing checklists and self-reports with open-ended measures, particularly for critical trial concepts, where the consequences of misunderstanding are potentially severe.
AB - OBJECTIVES: Informed consent and understanding are essential ethical requirements for clinical trial participation. Traditional binary measures of understanding may be limited and not be the best measures of level of understanding. This study designed and compared 4 measures of understanding for potential participants being prepared for enrollment in South African HIV vaccine trials, using detailed operational scoring criteria. METHODS: Assessment of understanding of 7 key trial components was compared via self-report, checklist, vignettes, and narrative measures. Fifty-nine participants, including members of vaccine preparedness groups and 1 HIV vaccine trial, took part. RESULTS: There were significant differences across the measures for understanding of 5 components and for overall understanding. Highest scores were obtained on self-report and checklist measures, and lowest scores were obtained for vignettes and narrative descriptions. CONCLUSIONS: The findings suggest that levels of measured understanding are dependent on the tools used. Forced-choice measures like checklists tend to yield higher scores than open-ended measures like narratives or vignettes. Consideration should be given to complementing checklists and self-reports with open-ended measures, particularly for critical trial concepts, where the consequences of misunderstanding are potentially severe.
KW - Consent
KW - Ethics
KW - HIV vaccine trials
KW - Understanding
UR - http://www.scopus.com/inward/record.url?scp=33845353426&partnerID=8YFLogxK
U2 - 10.1097/01.qai.0000247225.37752.f5
DO - 10.1097/01.qai.0000247225.37752.f5
M3 - Article
C2 - 17075389
AN - SCOPUS:33845353426
SN - 1525-4135
VL - 43
SP - 560
EP - 566
JO - Journal of Acquired Immune Deficiency Syndromes
JF - Journal of Acquired Immune Deficiency Syndromes
IS - 5
ER -