Enhancing Informed Consent: Lessons from Studies in Childhood Cancer
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Enhancing Informed Consent: Enhancing Informed Consent: Lessons from Studies in Lessons from Studies in
Childhood CancerChildhood Cancer
Eric Kodish, MD
Department of Bioethics
Lerner College of Medicine
Cleveland Clinic
SACHRP
October 28, 2009
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Pediatric EthicsPediatric Ethics“A branch of bioethics that analyzes moral aspects of decisions made relating to the health care of children.”
Lyren and Kodish
Encyclopedia of Bioethics
3rd Edition
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Informed Consent Informed Consent
in Pediatricsin Pediatrics = = Parental PermissionParental Permission
+ Assent of the + Assent of the ChildChild
A Misnomer
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The Beginning: Questions about Informed Consent
What is better informed consent?
A higher consent rate / better accrual numbers? A lower consent rate suggesting freedom to decline? Enhanced compliance with federal regulations? Improved understanding of the study by subjects? Empowered participants in control of the research decision?
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Project on Informed Consent (PIC):Research Strategy, 1999-2002
1. Describe current practice using direct observation methodology2. Learn from parents of children with cancer and collaborate to improve
the consent process.
Two Sources of Information
1. Direct Observation of Informed Consent Conferences (ICCs) and Parent Interviews
PIC is the 1st informed consent study to include direct observation
2. Parental Recommendations for Improving Informed Consent Focus Groups and the Parent Advisory Group on Informed Consent
(PAGIC)
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DIRECT OBSERVATION
FOCUS GROUPS
PAGICN = 9
N = 72
N = 140Year 1- 2
Year 3
Year 4
Project on Informed Consent:Research History
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The Informed Consent ProcessThe Informed Consent Process
Diagnosis Treatment End
Observed/taped conference(s) andinterviews
Telephone Interviews
Focus Groups PAGIC
Clinical Event
Research Event
Treatment at 4-6 months
Notification
Disclosure and consent conferences
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Results: Randomization was explained by physicians in 83% of cases and consent document was presented during the conference in 95% of cases. Interviews after the conference demonstrated that 68 (50%) of 137 parents did not understand randomization. Parents of racial minority and lower socioeconomic status were less likely to understand randomization (P<.001 for each). Discussion of specific clinical trial details and the presence of a nurse during the conference were associated with understanding. Eighty-four percent of children were enrolled in a leukemia trial.
Conclusions: Despite oral and written explanation, half of the parents in this study did not understand randomization for childhood leukemia trials. To make informed consent more effective, future research must seek to improve communication during this critical interchange.JAMA, 2004;291:470-475 www.jama.com
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Parental Understanding: Parental Understanding: ChoiceChoice
On a conceptual level, understanding choice is more than just On a conceptual level, understanding choice is more than just
understanding that trial participation is voluntary.understanding that trial participation is voluntary.
Understanding choice requires that parents/patients have a clear Understanding choice requires that parents/patients have a clear appreciation of the alternative(s) to study participation.appreciation of the alternative(s) to study participation.
33% of parents did 33% of parents did notnot understand that understand that they had a choice between participation they had a choice between participation in the RCT and off-study therapy.in the RCT and off-study therapy.
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Hiatus of Informed Consent, Hiatus of Informed Consent, PIC StudyPIC Study
Explained UnderstoodExplained Understood
by Cliniciansby Clinicians by Parentsby Parents
Choice: Choice: 89%89% 67%67%
Randomization:Randomization: 83%83% 49%49%
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Deficits in Parental UnderstandingDeficits in Parental Understanding
Source/cause of deficits in parental understanding is Source/cause of deficits in parental understanding is not clearnot clear
Whatever the cause, this evidence suggests that Whatever the cause, this evidence suggests that data driven interventionsdata driven interventions to improve the process of to improve the process of communication and information exchange can communication and information exchange can positively affect:positively affect:
Parental comfort levelParental comfort level Parental understandingParental understanding Parental involvementParental involvement
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Learning from Parents: The PAGIC ModelLearning from Parents: The PAGIC ModelWhat is Leukemia?
Current Treatment
Randomized Clinical Trial
Understand?
Yes
Understand?
Yes
No
No
Decision
Understand?No Yes
1st Meeting
2nd Meeting
1st or 2nd Meeting
Depending Upon Parents
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Why is interactivity important?Why is interactivity important?1) c/w conceptual ideal (bidirectional ICP)1) c/w conceptual ideal (bidirectional ICP)
2) Data from PIC show question asking a/w better parental 2) Data from PIC show question asking a/w better parental understandingunderstanding
IncreasedInteractivity
BetterUnderstanding
Intervention
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The MUlti-Site Intervention Study to Improve Consent
(MUISIC) 2003-2007
Intervention phase of MUISIC builds on accomplishments of the PIC study
Previous research identified deficits in informedconsent. MUISIC tests 2 (subsequently 3)
rationally-designed interventions that may improve outcomes for informed consent
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Specific Aims of MUISIC
1) To utilize our scientific understanding of the informed consent process in childhood leukemia trials to further develop, test and implement three data-based interventions to improve informed consent:
Physician-directed – teaching improved management of the informed consent conference
Parent-directed – delivered by nurse educators and based on the model of anticipatory guidance for informed consent
Parent-directed – delivered via DVD and based on the model of anticipatory guidance for informed consent
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Specific Aims of MUISIC, cont.
2) To conduct a clinical trial to test the effect of each intervention on three specific outcomes:
a. Parental comprehension of choice and alternative to clinical trial participation
b. Parental understanding of randomization
c. Parental participation during the informed consent process as measured by the number and quality of questions asked by parents
3) To determine if any one intervention is superior to a control group, and how the three interventions compare to one another.
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Study DesignStudy Design
MUISIC
Physician-DirectedIntervention
Control/No Intervention
Philadelphia
Washington, D.C.
Cleveland
Oakland
Atlanta (SR)
Los Angeles
Atlanta (Eg)
Parent-DirectedIntervention
(Nurse)
Parent-DirectedIntervention
(DVD) Pittsburgh
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Description of Intervention Models – Parent-Directed Nurse Intervention
Target of Target of Content of InterventionTraining Intervention Intervention Outcome
Nurse Parents Improved understanding of consent (parents);enhancedinvolvementof parents in theconsent process,relative to controls
Support and anticipatoryguidanceregarding informed consent conference
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Description of Intervention Models – Parent-Directed DVD Intervention
Target of Target of Content of InterventionTraining Intervention Intervention Outcome
DVD Parents Support andanticipatoryguidanceregardinginformed consentconference
Improvedunderstanding ofconsent (parents);enhancedinvolvementof parents in theconsent process,relative to controls
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Description of Intervention Models – Physician-Directed Intervention
Target of Target of Content of InterventionTraining Intervention Intervention Outcome
Physician Physicians Communication;listening skills;management ofconsent conference
Improvedunderstanding ofconsent (parents);enhanced involvementof parents in theconsent process,relative to controls
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Study DesignStudy Design
MUISIC
Physician-DirectedIntervention
Control/No Intervention
Philadelphia
Washington, D.C.
Cleveland
Oakland
Atlanta (SR)
Los Angeles
Atlanta (Eg)
Parent-DirectedIntervention
(Nurse)
Parent-DirectedIntervention
(DVD)Pittsburgh
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Distribution by Site
Parent (Nurse Delivered) Intervention SitesCL14LA10AI12
Parent (DVD Delivered) Intervention SitePI12
Physician Intervention SitesPH36DC22
Control SitesAT33OA 7
--------------------------------------------Total N = 146
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Demographics For All CasesDemographics For All Cases
DEMOGRAPHIC DEMOGRAPHIC CHARACTERISTICSCHARACTERISTICS
[MEAN (RANGE) / %][MEAN (RANGE) / %]
All Sites All Sites NN=134=134
Physician-Physician-Directed Directed
Intervention Intervention Site Site
NN=58=58
Parent-Parent-Directed Directed
Intervention Intervention Site Site
NN=36=36
Control Control SiteSiteNN=40=40
Parent AgeParent Age 35.2735.27(19-54)(19-54)
37.437.4(23-54)(23-54)
33.533.5(19-49)(19-49)
33.933.9(19-49)(19-49)
Patient AgePatient Age6.26.2
(0.4-18)(0.4-18)5.65.6
(1-8)(1-8)6.86.8
(1-18)(1-18)6.46.4
(0.4-18)(0.4-18)
Parent GenderParent Gender
(% Female)(% Female)75%75% 71%71% 81%81% 78%78%
Patient GenderPatient Gender(% Female)(% Female) 44%44% 40%40% 50%50% 45%45%
Parent EthnicityParent Ethnicity(% Minority)(% Minority) 45%45% 35%35% 61%61% 45%45%
ISPISP
1-21-2 36%36% 45%45% 31%31% 28%28%
33 22%22% 28%28% 17%17% 20%20%
4-54-5 42%42% 28%28% 53%53% 53%53%
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Features of the ICC – MUISIC StudyFeatures of the ICC – MUISIC Study
ICC FeatureICC Feature MeanMean RangeRange
LengthLength 80.13 min80.13 min 23-244 min23-244 min
# of participants# of participants 6.56.5 2-142-14
Feature N=134 [#, (%)]
Attending physician led ICC
100 (75%)
Fellow led ICC 34 (25%)
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Communicating Prognosis in the ICCCommunicating Prognosis in the ICC
Diagnosis
DiagnosisN=134[#, (%)]
Standard Risk ALL 62 (46%)
High Risk ALL 46 (34%)
AML 26 (19%)
COMMUNICATING PROGNOSISN=134[#, (%)]
Frames in terms of survival/cure 119 (89%)
Frames in terms of mortality 71 (53%)
Specific number info 98 (73%)
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Physician Training Seminars: Physician Training Seminars: Participant Numbers*Participant Numbers*
Physician-Directed Intervention Sites
Seminar 1(Dates of seminar)
Seminar 2(Dates of seminar)
Seminar 3(Dates of seminar)
Total trained physicians*
Washington, DC (CNMC)
4(2/12/2004)
5(9/9/2004)
5(7/7/2005) 14
Philadelphia, PA (CHOP)
13(3/12/2004)
9(10/21/2004)
7(9/13/2005) 29
*Seven physicians at CNMC and thirteen from CHOP attended booster seminars conducted after these full day seminars.
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102 total cases
60 physician- directed
intervention42 control
44 cases
2 excluded for missed ICC
40 cases
11 excluded for no offer of trial
14 excluded for no offer of trial
33 total physician-directed cases
26 total control cases
2 excluded for missed ICC
14 excluded for not attending
training seminar
Enrollment and group assignmentEnrollment and group assignment
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Observed Features of ICCObserved Features of ICC
ICC FeatureICC Feature[# (%)][# (%)]
Physician-Physician-DirectedDirectedInt. Site:Int. Site:TrainedTrained
NN=33=33
Parent-Parent-DirectedDirectedInt. SiteInt. Site
NN=21=21
Control SiteControl Site
NN=26=26
Right to withdrawRight to withdraw 26 (79%)26 (79%) 15 (71%)15 (71%) 21 (81%)21 (81%)
Described as Described as voluntaryvoluntary 29 (88%)29 (88%) 19 (91%)19 (91%) 19 (73%)19 (73%)
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Observed Features of ICCObserved Features of ICC
ICC FeatureICC Feature[# (%)][# (%)]
Physician-Physician-DirectedDirectedInt. Site:Int. Site:TrainedTrained
NN=33=33
Parent-Parent-DirectedDirectedInt. SiteInt. Site
NN=21=21
Control SiteControl Site
NN=26=26
Randomization Randomization explainedexplained 27 (82%)27 (82%) 21 (100%)21 (100%) 20 (77%)20 (77%)
Explains difference Explains difference between RCT and between RCT and non-RCTnon-RCT
32 (97%)32 (97%) 16 (76%)16 (76%) 21 (81%)21 (81%)
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Parent Interviews: Parent Interviews: Understanding by ParentsUnderstanding by Parents
Parent FeatureParent Feature[# / [# / NN (%)] (%)]
Physician-Physician-DirectedDirectedInt. Site:Int. Site:TrainedTrained
NN=33=33
Control SiteControl Site
NN=26=26
P valueP value
Understands Understands RandomizationRandomization**
20/26 (77%)20/26 (77%) 14/18 (78%)14/18 (78%) 0.9470.947
Distinguishes - Distinguishes - ChoiceChoice 28/33 (85%)28/33 (85%) 16/26 (62%)16/26 (62%) 0.0410.041
* Excludes participants offered non-randomized trials
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MUISIC vs. PIC:MUISIC vs. PIC:Understanding RandomizationUnderstanding Randomization
Comparing PIC study with MUISIC study Comparing PIC study with MUISIC study control group:control group:
Understanding randomization was only Understanding randomization was only 50%50% in PIC in PIC study with the larger group size of study with the larger group size of NN=140=140. .
Understanding randomization was Understanding randomization was 78%78% in MUISIC in MUISIC study for the smaller control group sample size of study for the smaller control group sample size of N=26N=26..
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Learning from Parents: The PAGIC ModelLearning from Parents: The PAGIC ModelWhat is Leukemia?
Current Treatment
Randomized Clinical Trial
Understand?
Yes
Understand?
Yes
No
No
Decision
Understand?No Yes
1st Meeting
2nd Meeting
1st or 2nd Meeting
Depending Upon Parents
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Sequence AnalysisSequence Analysis
* The first six coded variables were * The first six coded variables were considered to be part of “What is considered to be part of “What is leukemia?” and were noted as discussed leukemia?” and were noted as discussed during the ICC prior to discussion of during the ICC prior to discussion of current therapy more often in the PDI than current therapy more often in the PDI than control group cases.control group cases.
† † Side effects of therapy, outline treatment Side effects of therapy, outline treatment plan and length of treatment were items plan and length of treatment were items coded if they were discussed prior to coded if they were discussed prior to description RCT description RCT
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Fidelity to PAGIC ModelFidelity to PAGIC Model
Coded Variable
Physician-intervention cases(N=33)
Control cases(N=26) Probability
p Effect size
(ES)
Yes Yes
* Diagnosis discussion
93.9% 76.9% 0.058 17%
Discussion of prognosis
87.9% 57.7% 0.008 30%
Prognostic characteristic
78.8% 42.3% 0.004 37%
Definition of leukemia
78.8% 30.8% 0.000 48%
Review test results 72.7% 19.2% 0.000 54%
Definition of remission
75.8% 34.6% 0.001 41%
† Side effects of therapy
84.8% 38.5% 0.000 46%
Outline treatment plan
81.8% 61.5% 0.082 20%
Discuss length of treatment
81.8% 57.7% 0.042 24%
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Question asking by ParentsQuestion asking by Parents
Questions Sites NMean
(questions per 10 minutes)Probability
p
Research related PDI 33 1.5 (SD = 1.1)
0.2Control 26 1.1 (SD = 1.2)
Non-research related PDI 33 5.5 (SD = 3.3)
0.003Control 26 3.2 (SD = 2.3)
Total questions PDI 33 7.0 (SD = 4.0)
0.007Control 26 4.0 (SD = 3.3)
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Parent Interview Data: Parent Interview Data: Understanding by ParentsUnderstanding by Parents
Parent FeatureParent Feature[# / [# / NN (%)] (%)]
Physician-Physician-DirectedDirectedInt. Site:Int. Site:TrainedTrained
NN=33=33
Parent-Parent-DirectedDirectedInt. SiteInt. Site
NN=21=21
Control SiteControl Site
NN=26=26
Understands Understands RandomizationRandomization**
20/26 (77%)20/26 (77%) 12/19 (63%)12/19 (63%) 14/18 (78%)14/18 (78%)
Distinguishes - Distinguishes - ChoiceChoice 28/33 (85%)28/33 (85%) 17/21 (81%)17/21 (81%) 16/26 (62%)16/26 (62%)
* Excludes participants offered non-randomized trials
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Data on Parental Understanding OutcomesData on Parental Understanding Outcomes
Parental Understanding: Choice 85% of parents at physician-directed intervention sites (trained physician) and 81% of parents at parent-directed intervention sites understood that they had a choice between RCT and off-study therapy
Only 62% of parents at control sites understood that they had a choice
between RCT participation and off-study therapy
Parental Understanding: Randomization 77% of parents at physician-directed intervention sites (trained physician) and 63% of parents at parent-directed intervention sites understood that their child would be randomly assigned to one of RCT multiple arms
78% of parents at control sites understood that their child would be randomly assigned (remember this was 50% in PIC, with larger sample)
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Key Summary PointsKey Summary Points With attention to sequence, With attention to sequence,
choreography and communication choreography and communication science, we can improve the informed science, we can improve the informed consent process.consent process.
The lessons we have learned may not The lessons we have learned may not apply to other contexts.apply to other contexts.
More research is needed.More research is needed.
Support from NIH R01 CA 083267Support from NIH R01 CA 083267