Parental perspectives long term after neonatal clinical trial participation: a survey

Abstract

Background Although recruiting newborns is ethically challenging, clinical trials remain essential to improve neonatal care. There is a lack of empirical data on the parental perspectives following participation of their neonate in a clinical trial, especially at long term. The objective of this study is to assess experiences and emotions of parents, long term after trial participation in an interventional drug trial. Methods Parents of former participants of five neonatal interventional drug trials were surveyed at long term (3–13 years ago) after participation. The survey assessed parental contentment with trial participation, perceived influence of the trial on care and health, emotional consequences of participation, and awareness of typical clinical trial characteristics on 6-point Likert scales. Results Complete responses were received from 123 parents (52% of involved families). Twenty percent of parents did not remember participation. Those who remembered participation reported high contentment with overall trial participation (median 5.00), but not with follow-up (median 3.00). Most parents did not perceive any influence of the trial on care (median 2.00) and health (median 2.43). Almost all parents reported satisfaction and pride (median 4.40), while a minority of parents reported anxiety and stress (median 1.44) or guilt (median 1.33) related to trial participation. A relevant minority was unaware of typical trial characteristics (median 4.20; 27% being unaware). Conclusions Overall, parents reported positive experiences and little emotional distress long term after participation. Future efforts to improve the practice of neonatal clinical trials should focus on ensuring effective communication about the concept and characteristics of a clinical trial during consent discussions and on the follow-up after the trial.

Is staff consistency important to parents’ satisfaction in a longitudinal study of children at risk for type 1 diabetes: the TEDDY study

“…Like our study, others have reported that lower education level is associated with higher study satisfaction [ 3 , 8 ]. Being part of a longitudinal study with visits several times per year provides a parent with an opportunity to ask questions and talk to professionals about the child’s type 1 diabetes risk.…”

“…Studies examining factors associated with parent study satisfaction are also limited. Less educated parents and those from racial or ethnic minority groups often report greater satisfaction than higher educated parents or those from the majority culture [ 3 , 8 ]. Higher overall satisfaction was also associated with fewer transportation problems and fewer study-related financial difficulties [ 6 ].…”

Clinical Research in Neonates: Redesigning the Informed Consent Process in the Digital Era

“…In addition, it is considered important that parents are continuously educated about the study details and their rights ( 8 ). When long-term contact is established between parents and the research team via an eIC system, it could help to remind parents of their child's participation in a research study, which may be forgotten ( 45 ). As formulated by the interviewed HCPs, it could be up to the parents to indicate how they would like to receive information.…”