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Assessment of parental decision-making in neonatal cardiac research: a pilot study
Aruna T Nathan1, K Sarah Hoehn, Richard F Ittenbach
1Department of Anesthesiology and Critical Care Medicine, University of Pennsylvania, Pennsylvania, USA. nathan@email.chop.edu
Insights
Parents of critically ill newborns demonstrate competence in research decision-making. The MacArthur competence assessment tool for clinical research (MacCAT-CR) effectively assesses parental permission for neonatal research participation.
Area of Science:
- Neonatal research ethics
- Clinical trial consent
- Parental decision-making
Background:
- Assessing parental capacity to consent for neonatal research is crucial.
- The emotional stress of having a critically ill infant can impact decision-making.
- The MacArthur competence assessment tool for clinical research (MacCAT-CR) is a potential measure for this capacity.
Purpose of the Study:
- To evaluate the utility of the MacCAT-CR in assessing parental permission for neonatal research.
- To determine if parents of critically ill newborns can provide informed consent despite high-stress situations.
- To compare MacCAT-CR scores between different diagnostic groups and demographic factors.
Main Methods:
- Quantitative interviews were conducted using study-specific MacCAT-CR tools.
- Participants included parents of neonates undergoing cardiac surgery who had already made research participation decisions.
- The MacCAT-CR assesses understanding, appreciation, reasoning, and choice regarding research participation.
Main Results:
- 35 parents of 24 neonates completed interviews for three different studies.
- Parents generally achieved higher MacCAT-CR scores than published subject populations, comparable to controls.
- Specific study scores varied: MRI (36.6), genetics (38.8), and heart rate variability (37.7).
Conclusions:
- The MacCAT-CR is a viable tool for assessing parental permission in neonatal research.
- Parents of critically ill neonates demonstrated understanding and made informed decisions regarding research participation.
- The tool's effectiveness was confirmed despite the stressful context of neonatal surgery.
Objective:
To assess parental permission for a neonate's research participation using the MacArthur competence assessment tool for clinical research (MacCAT-CR), specifically testing the components of understanding, appreciation, reasoning and choice.
Study Design:
Quantitative interviews using study-specific MacCAT-CR tools.
Hypothesis:
Parents of critically ill newborns would produce comparable MacCAT-CR scores to healthy adult controls despite the emotional stress of an infant with critical heart disease or the urgency of surgery. Parents of infants diagnosed prenatally would have higher MacCAT-CR scores than parents of infants diagnosed postnatally. There would be no difference in MacCAT-CR scores between parents with respect to gender or whether they did or did not permit research participation.
Participants:
Parents of neonates undergoing cardiac surgery who had made decisions about research participation before their neonate's surgery.
Methods:
The MacCAT-CR.
Results:
35 parents (18 mothers; 17 fathers) of 24 neonates completed 55 interviews for one or more of three studies. Total scores: magnetic resonance imaging (mean 36.6, SD 7.71), genetics (mean 38.8, SD 3.44), heart rate variability (mean 37.7, SD 3.30). Parents generally scored higher than published subject populations and were comparable to published control populations with some exceptions.
Conclusions:
The MacCAT-CR can be used to assess parental permission for neonatal research participation. Despite the stress of a critically ill neonate requiring surgery, parents were able to understand study-specific information and make informed decisions to permit their neonate's participation.
