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:

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Advocate Hope Childrens Hospital Advocate
Lutheran General Childrens Hospital
Parent Decision Making in Pediatric Research
Denise B. Angst, PhD, RN Emily Hadley, MS,
RN Bryan Coyle, MA Advocate Center for
Pediatric Research Advocate IRB
Parent Decision Making in Pediatric Research
Denise B. Angst, PhD, RN Emily Hadley, MS,
RN Bryan Coyle, MA Advocate Center for
Pediatric Research Advocate IRB
Results
Methods
Results
Background

• 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
• 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

Table 2. Selected DM Survey Item Responses
Decision Making Survey

• 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 (gt7yrs.) are asked to give assent.
• Much of the previous research related to parents
  decision making around childrens 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 childs participation in research
• Time constraints
• Complicated research protocols
• Inadequate understanding
• Stress imposed by childs condition
• Less than ideal communication

• Based on analysis of first 50 parents
• 2-3 domains / scales appear to have subscales
• Internal consistency ? 0.41-0.87 7 scales with
  ? gt0.74
• Discrimination Enrolled vs. Declined
• Most scales did not discriminate based on
  participation
• 3 scales showed differences Decisional
  Uncertainty, Influence of Childs 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 N 55 (n, Agreed or Strongly Agreed) Declined N 14 (n, Agreed or Strongly Agreed) p-value
Altruism Altruism Altruism Altruism
Participating in Research will Help Other Children 53 (96) 12 (86) 0.18
Decisional Uncertainty Decisional Uncertainty Decisional Uncertainty Decisional Uncertainty
Wanted Study Doctor to Advise me on Decision 14 (26) 2 (14) 0.49
Child Influences Child Influences Child Influences Child Influences
Would Participate in Any Study to Benefit Child 44 (81) 4 (29) 0.0003
Study Characteristics Study Characteristics Study Characteristics Study Characteristics
Study Seemed Very Risky 2 (4) 7 (50) 0.001
Trust / Relationship with Dr. and Staff Trust / Relationship with Dr. and Staff Trust / Relationship with Dr. and Staff Trust / Relationship with Dr. and Staff
Study Wouldnt have been Offered unless Beneficial 36 (65) 5 (36) 0.07
Understanding Understanding Understanding Understanding
I Understood What was Required 46 (84) 9 (64) 0.14
Quality of Permission / Consent Process Quality of Permission / Consent Process Quality of Permission / Consent Process Quality of Permission / Consent Process
Had Enough Time to Make Decision 43 (78) 8 (57) 0.17
Satisfaction with Decision Making Satisfaction with Decision Making Satisfaction with Decision Making Satisfaction with Decision Making
Make Same Decision Again 44 (81) 13 (93) 0.44
Next Steps

• Parents are continuing to be enrolled goal N100
  parents

Conclusions
Results

• 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 lt1
  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 childs 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

• 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 lt 1day.

N 53 N 54
Table 3. Parent Perceptions Enrolled vs.
Declined
Enrolled N 55 (mean, SD) Declined N 14 (mean, SD) p-value
Perception of Seriousness of Childs Condition (1mild, 10 severe) 7.2 (2.5) 7.2 (2.2) .96
Benefit for Child (1no benefit, 10 extremely beneficial) 6.1 (3.0) 2.5 (2.1) .0001
Benefit for Other Children (1no benefit, 10 extremely beneficial) 8.4 (2.2) 6.2 (2.0) .002
Perception of Risk (1no risk, 10 extremely risky) 3.4 (2.3) 6.4 (2.6) .0002
Importance of Research (1not impt., 10 extremely impt.) 8.6 (2.0) 6.2 (1.6) .0002
Table 1. Sample Characteristics Enrolled vs.
Declined
Enrolled N 55 (n, ) Declined N 14 (n, ) All Parents N 69 (n, )
Childs Condition Oncology Neonatology Other Chronic Condition 32 (58) 15 (27) 8 (15) 1 (7) 9 (64) 4 (29) 33 (48) 24 (35) 12 (17)
Childs Age lt 1 month 2-10 years 11-17 years 13 (34) 13 (34) 12 (32) 11 (92) 1 (8) 0 24 (48) 14 (28) 12 (24)
Parents Highest Education High school grad Some college gt College grad 10 (18) 15 (27) 30 (55) 1 (7) 2 (14) 11 (79) 11 (16) 17 (25) 41 (59)
Race/ Ethnicity Caucasian African American Other 42 (76) 6 (11) 7 (13) 13 (93) 0 1 (7) 55 (80) 6 (9) 8 (11)
Annual Household Income lt 50k 50k - 89,999 90k 17 (32) 16 (29) 20 (38) 0 5 (36) 9 (64) 17 (25) 21 (30) 29 (42)
Specific Aims

• Examine parents decision making regarding their
  childrens research participation across various
  illness and other contexts
• To develop and evaluate an instrument that could
  be used across pediatric conditions and decision
  making contexts.

Parents of Children with Cancer vs. Other
Conditions

• Compared to parents of children with other
  conditions, parents of children with cancer
  viewed,
• Their childs condition as more serious (8.2 vs.
  6.3 p0.002)
• The research as more important (6.8 vs. 4.1
  p0.0005)
• The research as benefiting their child (8.8 vs.
  7.5 p0.01)
• However, there were no statistically significant
  differences in their perception of study risks
  (4.1 vs. 3.9 p0.68)

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.