Child and Parent Understanding of Clinical Trials: The Semi-Structured Comprehension Interview

Erin Talati Paquette, Julie Najita, Debra Morley, Steven Joffe*

*Corresponding author for this work

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background: Understanding is an important goal of the informed consent process in research. We sought to assess the interrater reliability (IRR) and concurrent validity of two measures of understanding in child and young adult subjects and their parents. Methods: We conducted a cross-sectional survey and interview-based study of children and young adults participating in a clinical trial for cancer, along with one parent per child or young adult subject. We estimated the IRR of the Semi-Structured Comprehension Interview (SSCI) and the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). We also estimated concordance between the SSCI, the MacCAT-CR, and the Quality of Informed Consent (QuIC). Results: For our sample of 32 subjects (16 parent–child pairs), IRR estimates were high for total score on the SSCI (intraclass correlation coefficient [ICC] = 0.88, 95% confidence interval [CI] = 0.76–0.94), as well as on the understanding (ICC = 0.93, 95% CI = 0.86–0.97) and reasoning (ICC = 0.97, 95% CI = 0.94–0.98) subscales of the MacCAT-CR. IRR was lower for the appreciation subscale of the MacCAT-CR (ICC = 0.70, 95% CI = 0.47–0.84). Scores on the SSCI were strongly correlated with scores on the understanding subscale of the MacCAT-CR (Spearman's rho = 0.72, 95% CI = 0.48–0.85) and the QuIC (Spearman's rho = 0.66, 95% CI = 0.24–0.87). Mean administration time for the SSCI was 3.1 minutes (95% CI = 2.7–3.5 minutes). Conclusions: The SSCI is a valid and reliable measure of understanding for use with both pediatric and adult research participants. It is easy to administer and score consistently, even by nonprofessional raters. The SSCI is a promising tool for use by clinician-investigators to study, detect, and correct deficiencies in understanding among children, adolescents, and adults making decisions about research participation.

Original languageEnglish (US)
Pages (from-to)23-32
Number of pages10
JournalAJOB Empirical Bioethics
Volume6
Issue number2
DOIs
StatePublished - Apr 3 2015

Fingerprint

competence assessment
comprehension
parents
Clinical Trials
Interviews
confidence
Confidence Intervals
Mental Competency
interview
Research
Informed Consent
young adult
Young Adult
Confidence Interval
Reproducibility of Results
Decision Making
cancer
Cross-Sectional Studies
Parents
Research Personnel

Keywords

  • assent
  • ethics
  • informed consent
  • parental consent
  • research ethics

ASJC Scopus subject areas

  • Health(social science)
  • Philosophy
  • Health Policy

Cite this

@article{582dec5ab9be4d709f750977d2444e93,
title = "Child and Parent Understanding of Clinical Trials: The Semi-Structured Comprehension Interview",
abstract = "Background: Understanding is an important goal of the informed consent process in research. We sought to assess the interrater reliability (IRR) and concurrent validity of two measures of understanding in child and young adult subjects and their parents. Methods: We conducted a cross-sectional survey and interview-based study of children and young adults participating in a clinical trial for cancer, along with one parent per child or young adult subject. We estimated the IRR of the Semi-Structured Comprehension Interview (SSCI) and the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). We also estimated concordance between the SSCI, the MacCAT-CR, and the Quality of Informed Consent (QuIC). Results: For our sample of 32 subjects (16 parent–child pairs), IRR estimates were high for total score on the SSCI (intraclass correlation coefficient [ICC] = 0.88, 95{\%} confidence interval [CI] = 0.76–0.94), as well as on the understanding (ICC = 0.93, 95{\%} CI = 0.86–0.97) and reasoning (ICC = 0.97, 95{\%} CI = 0.94–0.98) subscales of the MacCAT-CR. IRR was lower for the appreciation subscale of the MacCAT-CR (ICC = 0.70, 95{\%} CI = 0.47–0.84). Scores on the SSCI were strongly correlated with scores on the understanding subscale of the MacCAT-CR (Spearman's rho = 0.72, 95{\%} CI = 0.48–0.85) and the QuIC (Spearman's rho = 0.66, 95{\%} CI = 0.24–0.87). Mean administration time for the SSCI was 3.1 minutes (95{\%} CI = 2.7–3.5 minutes). Conclusions: The SSCI is a valid and reliable measure of understanding for use with both pediatric and adult research participants. It is easy to administer and score consistently, even by nonprofessional raters. The SSCI is a promising tool for use by clinician-investigators to study, detect, and correct deficiencies in understanding among children, adolescents, and adults making decisions about research participation.",
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author = "Paquette, {Erin Talati} and Julie Najita and Debra Morley and Steven Joffe",
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Child and Parent Understanding of Clinical Trials : The Semi-Structured Comprehension Interview. / Paquette, Erin Talati; Najita, Julie; Morley, Debra; Joffe, Steven.

In: AJOB Empirical Bioethics, Vol. 6, No. 2, 03.04.2015, p. 23-32.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Child and Parent Understanding of Clinical Trials

T2 - The Semi-Structured Comprehension Interview

AU - Paquette, Erin Talati

AU - Najita, Julie

AU - Morley, Debra

AU - Joffe, Steven

PY - 2015/4/3

Y1 - 2015/4/3

N2 - Background: Understanding is an important goal of the informed consent process in research. We sought to assess the interrater reliability (IRR) and concurrent validity of two measures of understanding in child and young adult subjects and their parents. Methods: We conducted a cross-sectional survey and interview-based study of children and young adults participating in a clinical trial for cancer, along with one parent per child or young adult subject. We estimated the IRR of the Semi-Structured Comprehension Interview (SSCI) and the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). We also estimated concordance between the SSCI, the MacCAT-CR, and the Quality of Informed Consent (QuIC). Results: For our sample of 32 subjects (16 parent–child pairs), IRR estimates were high for total score on the SSCI (intraclass correlation coefficient [ICC] = 0.88, 95% confidence interval [CI] = 0.76–0.94), as well as on the understanding (ICC = 0.93, 95% CI = 0.86–0.97) and reasoning (ICC = 0.97, 95% CI = 0.94–0.98) subscales of the MacCAT-CR. IRR was lower for the appreciation subscale of the MacCAT-CR (ICC = 0.70, 95% CI = 0.47–0.84). Scores on the SSCI were strongly correlated with scores on the understanding subscale of the MacCAT-CR (Spearman's rho = 0.72, 95% CI = 0.48–0.85) and the QuIC (Spearman's rho = 0.66, 95% CI = 0.24–0.87). Mean administration time for the SSCI was 3.1 minutes (95% CI = 2.7–3.5 minutes). Conclusions: The SSCI is a valid and reliable measure of understanding for use with both pediatric and adult research participants. It is easy to administer and score consistently, even by nonprofessional raters. The SSCI is a promising tool for use by clinician-investigators to study, detect, and correct deficiencies in understanding among children, adolescents, and adults making decisions about research participation.

AB - Background: Understanding is an important goal of the informed consent process in research. We sought to assess the interrater reliability (IRR) and concurrent validity of two measures of understanding in child and young adult subjects and their parents. Methods: We conducted a cross-sectional survey and interview-based study of children and young adults participating in a clinical trial for cancer, along with one parent per child or young adult subject. We estimated the IRR of the Semi-Structured Comprehension Interview (SSCI) and the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). We also estimated concordance between the SSCI, the MacCAT-CR, and the Quality of Informed Consent (QuIC). Results: For our sample of 32 subjects (16 parent–child pairs), IRR estimates were high for total score on the SSCI (intraclass correlation coefficient [ICC] = 0.88, 95% confidence interval [CI] = 0.76–0.94), as well as on the understanding (ICC = 0.93, 95% CI = 0.86–0.97) and reasoning (ICC = 0.97, 95% CI = 0.94–0.98) subscales of the MacCAT-CR. IRR was lower for the appreciation subscale of the MacCAT-CR (ICC = 0.70, 95% CI = 0.47–0.84). Scores on the SSCI were strongly correlated with scores on the understanding subscale of the MacCAT-CR (Spearman's rho = 0.72, 95% CI = 0.48–0.85) and the QuIC (Spearman's rho = 0.66, 95% CI = 0.24–0.87). Mean administration time for the SSCI was 3.1 minutes (95% CI = 2.7–3.5 minutes). Conclusions: The SSCI is a valid and reliable measure of understanding for use with both pediatric and adult research participants. It is easy to administer and score consistently, even by nonprofessional raters. The SSCI is a promising tool for use by clinician-investigators to study, detect, and correct deficiencies in understanding among children, adolescents, and adults making decisions about research participation.

KW - assent

KW - ethics

KW - informed consent

KW - parental consent

KW - research ethics

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