Parental Enrollment Decision-Making for a Neonatal Clinical Trial.

OBJECTIVE: To describe the parental experience of recruitment and assess differences between parents who participated and those who declined to enroll in a neonatal clinical trial. STUDY DESIGN: This was a survey conducted at 12 US neonatal intensive care units of parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and encephaLopathy (HEAL) trial or who were eligible but declined enrollment. Questions assessed 6 factors of the parental experience of recruitment: (1) interactions with research staff; (2) the consent experience; (3) perceptions of the study; (4) decisional conflict; (5) reasons for/against participation; and (6) timing of making the enrollment decision. RESULTS: In total, 269 of 387 eligible parents, including 183 of 242 (75.6%) of those who enrolled their children in HEAL and 86 of 145 (59.3%) parents who declined to enroll their children in HEAL, were included in analysis. Parents who declined to enroll more preferred to be approached by clinical team members rather than by research team members (72.9% vs 49.2%, P = .005). Enrolled parents more frequently reported positive initial impressions (54.9% vs 10.5%, P < .001). Many parents in both groups made their decision early in the recruitment process. Considerations of reasons for/against participation differed by enrollment status. CONCLUSIONS: Understanding how parents experience recruitment, and how this differs by enrollment status, may help researchers improve recruitment processes for families and increase enrollment. The parental experience of recruitment varied by enrollment status. These findings can guide future work aiming to inform optimal recruitment strategies for neonatal clinical trials.

Parental Perspectives on Diagnosis and Prognosis of Neonatal Intensive Care Unit Graduates with Cerebral Palsy.

OBJECTIVES: To describe how parents of neonatal intensive care unit (NICU) graduates with cerebral palsy (CP) perceive both the accuracy of prognoses provided in the NICU and the timing of their child's diagnosis of CP, and to assess the influence of functional outcome on these perceptions. STUDY DESIGN: We surveyed parents of NICU graduates with CP about timing and benefit of diagnosis, accuracy of prognosis, and functional abilities of their children. After piloting and validation, CP parent support groups circulated the survey on social media, websites, and email lists. Bivariate relationships between categorical responses to survey questions were assessed with the χ2 test, and multivariable logistic regression was performed to identify independent factors associated with perceptions about the timing of diagnosis. RESULTS: Parents of 463 children were included. Two-thirds (67%) of the children were diagnosed with CP before age 2 years, yet 40% of the respondents felt that diagnosis was made late, and only 11% categorized diagnosis as early. More than one-half (59%) perceived a benefit to diagnosis. There was a significant association between earlier age at diagnosis and greater functional limitations; 24% of parents who recalled being given a prognosis reported that their child functioned as predicted, and 46% reported that their child exceeded expectations. Parents were more likely to believe that children with fewer functional limitations had exceeded expectations. CONCLUSION: Parents remember prognostic discussions about children who develop CP as underestimating functional outcome. Diagnosis is rarely seen as early and is associated with benefits. These observations suggest that clinicians should aim to diagnose CP early and to maintain guarded optimism about future outcomes. Tools for improved communication are urgently needed.