Transcript Document 7341850

Parent
Decision
Making
in Pediatric
Research
Parent
Decision
Making
in Pediatric
Research
Advocate Hope Children’s Hospital
Advocate Lutheran General Children’s Hospital
*; Emily
*; Bryan
#
*
*
Denise Denise
B. Angst,
PhD,
RN
Hadley,
MS,
RN
Coyle,
MA
B. Angst, PhD, RN ; Emily Hadley, MS, RN ; Bryan Coyle, MA#
*; Advocate
#
*
Advocate
Center
for
Pediatric
Research
IRB
Advocate Center for Pediatric Research ; Advocate IRB#
Background
 Federal mandates exist from both NIH and FDA on
including children in clinical research. However,
when and how to include children, particularly in
clinical trials, is highly debated. Concerns are
particularly heightened when:
 Children have life-threatening conditions
 There is little time to make this decision
 Parents / legal guardians give permission for their
children to participate in research. Older children
(~>7yrs.) are asked to give assent.
 Much of the previous research related to parents’
decision making around children’s participation in
research has been conducted separately in the
contexts of pediatric cancer, surgery or neonatology.
 There are many barriers to informed permission /
consent when parents are asked to make decisions
about their child’s participation in research:





Time constraints
Complicated research protocols
Inadequate understanding
Stress imposed by child’s condition
Less than ideal communication
Specific Aims
1) Examine parents’ decision making regarding their
children’s research participation across various illness
and other contexts
2) To develop and evaluate an instrument that could be
used across pediatric conditions and decision making
contexts.
Methods
Sample
Any parent who enrolled or declined enrollment of their child in
a clinical research study at AHCH or ALGCH
Approached within 12 weeks of the original study
English-speaking
Measurements
Results
Results
Table 2. Selected DM Survey Item Responses
Decision Making Survey
 Based on analysis of first 50 parents
 2-3 domains / scales appear to have subscales
 Internal consistency: = 0.41-0.87; 7 scales with  >0.74
 Discrimination: Enrolled vs. Declined
 Most scales did not discriminate based on participation
 3 scales showed differences: Decisional Uncertainty,
Influence of Child’s Condition, View of Study
 Discrimination: Diagnostic Groups
 Oncology vs. NICU vs. Other Chronic Condition
 6 scales appear to differentiate groups: Quality of
Consent Process-1, Quality of Consent Process-2,
View of Study, Other Decisional Influences, Trust /
Relationship with Dr. / Staff, Quality of Consent Form
Enrolled
Declined
N = 55
(n, % Agreed or
Strongly Agreed)
N = 14
(n, % Agreed or
Strongly Agreed)
53 (96)
12 (86)
0.18
14 (26)*
2 (14)
0.49
44 (81)#
4 (29)
0.0003
2 (4)
7 (50)
0.001
36 (65)
5 (36)
0.07
46 (84)
9 (64)
0.14
43 (78)
8 (57)
0.17
44 (81) #
13 (93)
0.44
Altruism
Participating in Research will Help Other Children
Demographic and Decision Making Supplement
 31 items, evaluating parent and child demographics;
perception of research risks and benefits, previous
experience with research, decision making process
Parent Decision Making (DM) Survey
 Based loosely on survey by Tait et al.
 65 items were reviewed by 5 content experts
 Final tool was 70 items, each item with a 5-point Likert scale
(1 strongly disagree – 5 strongly agree), organized in 11
themes/domains
Data Analysis
Descriptive statistics; t-tests to compare subgroups
Reliabilities and correlational analyses to evaluate DM survey
Decisional Uncertainty
Wanted Study Doctor to Advise me on Decision
Child Influences
Would Participate in Any Study to Benefit Child
Study Characteristics
Study Seemed Very Risky
Trust / Relationship with Dr. and Staff
Study Wouldn’t have been Offered unless Beneficial
Understanding
I Understood What was Required
Quality of Permission / Consent Process
Had Enough Time to Make Decision
Satisfaction with Decision Making
Results
Make Same Decision Again
Parents completed DM supplement and survey at a median of
7 days from their decision making regarding the original research.
75% parents made their decision re: the original study in < 1day.
*N
Enrolled
Declined
All Parents
N = 55
(n, %)
N = 14
(n, %)
N = 69
(n, %)
1 (7)
9 (64)
4 (29)
33 (48)
24 (35)
12 (17)
32 (58)
15 (27)
8 (15)
Perception of Seriousness of Child’s Condition
24 (48)
14 (28)
12 (24)
10 (18)
15 (27)
30 (55)
1 (7)
2 (14)
11 (79)
11 (16)
17 (25)
41 (59)
42 (76)
6 (11)
7 (13)
13 (93)
0
1 (7)
55 (80)
6 (9)
8 (11)
17 (32)
16 (29)
20 (38)
0
5 (36)
9 (64)
17 (25)
21 (30)
29 (42)
Declined
N = 55
(mean, SD)
N = 14
(mean, SD)
pvalue
7.2 (2.5)
7.2 (2.2)
.96
6.1 (3.0)
2.5 (2.1)
.0001
8.4 (2.2)
6.2 (2.0)
.002
3.4 (2.3)
6.4 (2.6)
.0002
8.6 (2.0)
6.2 (1.6)
.0002
(1=no benefit, 10 = extremely beneficial)
Benefit for Other Children
(1=no benefit, 10 = extremely beneficial)
Perception of Risk
11 (92)
1 (8)
0
Enrolled
(1=mild, 10 = severe)
Benefit for Child
13 (34)
13 (34)
12 (32)
= 53 # N = 54
Table 3. Parent Perceptions: Enrolled vs. Declined
Table 1. Sample Characteristics: Enrolled vs. Declined
Child’s Condition
Oncology
Neonatology
Other Chronic Condition
Child’s Age
< 1 month
2-10 years
11-17 years
Parent’s Highest Education
High school grad
Some college
> College grad
Race/ Ethnicity
Caucasian
African American
Other
Annual Household Income
< $50k
$50k - 89,999
≥ 90k
pvalue
(1=no risk, 10 = extremely risky)
Importance of Research
(1=not impt., 10 = extremely impt.)
Parents of Children with Cancer vs. Other Conditions
Compared to parents of children with other conditions, parents of
children with cancer viewed,
 Their child’s condition as more serious (8.2 vs. 6.3; p=0.002)
 The research as more important (6.8 vs. 4.1; p=0.0005)
 The research as benefiting their child (8.8 vs. 7.5; p=0.01)
However, there were no statistically significant differences in
their perception of study risks (4.1 vs. 3.9; p=0.68)
Next Steps
 Parents are continuing to be enrolled; goal N=100 parents
Conclusions
 These results are most representative of parents who
decide to enroll (vs. decline enrollment), and only
represent some of our preliminary analyses to date
 The vast majority of parents are making this decision in a
very short period of time (75% <1 day)
 Fewer parental resources (education, SES) may make it
more difficult for them to decline
 Features that distinguish those who enroll vs. decline
appear consistent with prior research:
 Beliefs in benefits for their child and other children
 Beliefs in the importance of research
 Perception of risks
 Compared to other conditions, parents of children with
cancer see the research as benefiting their child and see
their child’s condition as more serious
 Decision making tool results are highly preliminary, given
sample size. Tool shows some promise, but needs further
evaluation when additional parents have been enrolled
Acknowledgements
Thanks to the research coordinators and clinical staff who assisted in
recruiting parents: Ramona Donovan, Rina DiMaso, Bonnie Hughes, Suellen
Moen, Lorene Schweig, Regina Schwartz, and Jane Suszek.