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.

Conflicto decisional en salud en mujeres cuidadoras / Health decisional conflict in female care givers

Objetivos: la población de mujeres cuidadoras es un grupo que por sus características necesita especialmente ser estudiada respecto a las variables que están involucradas en los conflictos decisionales de salud a los que se enfrentan. Para ello se plantearon dos objetivos: captar la esencia de variables latentes de conflicto decisional en salud en mujeres cuidadoras informales. Construir tipologías de mujeres que experimentan este conflicto en salud, en una muestra de 50 mujeres de la Comuna de Concepción, Chile. Métodos: se realizó un estudio exploratorio, utilizando la técnica de análisis factorial para variables categóricas, seguido por un análisis de clasificación. Resultados: los resultados arrojaron 2 dimensiones, una que se interpretó como conocimientos para enfrentar el conflicto y la segunda como recursos personales que favorecen la toma de decisión. Conclusiones: el análisis de clasificación permitió identificar 4 grupos distintos de mujeres cuidadoras que enfrentan conflictos decisionales(AU)

Objetives: the population of female care givers is a group that due to their characteristics need to be specially studied as regards the variables involved in the health decisional conflicts they have to face. Two goals were established to this end: to capture the essence of latent variables of health decisional conflict in informal care givers, and to construct typologies of women experimenting this conflict in health, in a sample of 50 females from Comuna de la Concepción, Chile. Methods: an exploratory study was conducted by using the technique of factorial analysis for categorical variables, followed by a classification analysis. Results: the results showed 2 dimensions, one that was interpreted as knowledge to face the conflict and the second as personal resources that favor the decision-making. Conclusions: the classification analysis allowed to identify 4 different groups of female care givers that face decisional conflicts(AU)