Parental experiences of being approached to join multiple neonatal clinical trials: qualitative study (PARENT)
Parental experiences of being approached to join multiple neonatal clinical trials: qualitative study (PARENT)
Objective: to explore parents' perceptions and experience of being approached for enrolment of their preterm infant in more than one trial or study.
Design: a qualitative study involving 17 in-depth semistructured interviews, with parents who had been approached for multiple studies and who subsequently consented for their infant(s) to join at least one. Parents who declined all studies were not approached.
Setting and participants: parents of preterm infants receiving care at one of three neonatal intensive care units in the north of England.
Findings: most parents did not view concurrent participation in multiple trials or studies as a significant issue within the wider context of their infant's care. Most parents did not feel pressured into enrolling their infant into more than one study, but some suggested that participation in several provided justification for the subsequent refusal to join others, articulating feeling of guilt at saying 'no', and others appeared fatigued by multiple approaches. Parents focused on the perceived risks and benefits of each individual study and, while acknowledging that making a fully informed decision was not possible, largely agreed due to their belief in the benefits of research, trust in the health professionals caring for their baby and a range of complex personal motivations.
Conclusions: parents valued the autonomy to make decisions about participation and felt, with hindsight, that their decisions were right. Research teams could be more aware of parental feelings of guilt or gratitude that may motivate them to give consent. Similarly, the capacity of parents to fully remember details of multiple studies when they are stressed, and their infant is sick, should be taken into consideration, and continued efforts should be made to ensure ongoing consent to participation.
ethics, neonatology, qualitative research
F84-F87
Richards, Judy
5589e5b6-fad2-4bc7-a549-04ccafdb9c34
Rankin, Judith
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Juszczak, Ed
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Dorling, Jon
e55dcb9a-a798-41a1-8753-9e9ff8aab630
McGuire, William
aed9d25e-dc0a-4813-96e1-156c268e005c
Embleton, Nicholas D.
5c621f1e-cee5-4efa-ac43-8a195410c11c
11 December 2020
Richards, Judy
5589e5b6-fad2-4bc7-a549-04ccafdb9c34
Rankin, Judith
ddb311fa-7fd1-4d3a-a10a-727fc52320a9
Juszczak, Ed
a4f66edd-e590-4ba4-8aba-cc8f1fd955aa
Dorling, Jon
e55dcb9a-a798-41a1-8753-9e9ff8aab630
McGuire, William
aed9d25e-dc0a-4813-96e1-156c268e005c
Embleton, Nicholas D.
5c621f1e-cee5-4efa-ac43-8a195410c11c
Richards, Judy, Rankin, Judith, Juszczak, Ed, Dorling, Jon, McGuire, William and Embleton, Nicholas D.
(2020)
Parental experiences of being approached to join multiple neonatal clinical trials: qualitative study (PARENT).
Archives of Disease in Childhood: Fetal and Neonatal Edition, 106 (1), .
(doi:10.1136/archdischild-2020-319031).
Abstract
Objective: to explore parents' perceptions and experience of being approached for enrolment of their preterm infant in more than one trial or study.
Design: a qualitative study involving 17 in-depth semistructured interviews, with parents who had been approached for multiple studies and who subsequently consented for their infant(s) to join at least one. Parents who declined all studies were not approached.
Setting and participants: parents of preterm infants receiving care at one of three neonatal intensive care units in the north of England.
Findings: most parents did not view concurrent participation in multiple trials or studies as a significant issue within the wider context of their infant's care. Most parents did not feel pressured into enrolling their infant into more than one study, but some suggested that participation in several provided justification for the subsequent refusal to join others, articulating feeling of guilt at saying 'no', and others appeared fatigued by multiple approaches. Parents focused on the perceived risks and benefits of each individual study and, while acknowledging that making a fully informed decision was not possible, largely agreed due to their belief in the benefits of research, trust in the health professionals caring for their baby and a range of complex personal motivations.
Conclusions: parents valued the autonomy to make decisions about participation and felt, with hindsight, that their decisions were right. Research teams could be more aware of parental feelings of guilt or gratitude that may motivate them to give consent. Similarly, the capacity of parents to fully remember details of multiple studies when they are stressed, and their infant is sick, should be taken into consideration, and continued efforts should be made to ensure ongoing consent to participation.
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More information
Accepted/In Press date: 30 June 2020
e-pub ahead of print date: 31 July 2020
Published date: 11 December 2020
Additional Information:
Funding Information:
Funding The study was sponsored by Newcastle Hospitals NHS Foundation Trust and funded by Funded by the Health Technology Assessment Programme of the National Institute for Health Research, UK.
This study was focused on parents’ experiences whose infants were invited to join either of two clinical trials funded by the National Institute for Health Research (NIHR). These RCTs were (1) the Speed of Increases in Feeds Trial, an unmasked RCT comparing two different daily increments in milk feed volumes, and (2) the Enteral Lactoferrin in Neonates trial, a blinded RCT trial of supplemental enteral lactoferrin.10 11 These trials were linked to an NIHR funded mechanistic study,12 and further details of other trials and studies that were active at this time are provided in the online supplementary table. After PPI discussion, we only requested ethics permission to interview parents whose infants had joined at least one trial or study, even if they chose to decline others. Therefore, we did not approach parents who had declined participation in all trials or studies they were offered. Parents were recruited when their infant was medically stable and prior to hospital discharge. For further details on participants, procedures and data analysis, please see the online supplementary materials.
Keywords:
ethics, neonatology, qualitative research
Identifiers
Local EPrints ID: 485010
URI: http://eprints.soton.ac.uk/id/eprint/485010
ISSN: 1359-2998
PURE UUID: c6e4b77a-97e1-46c2-aca3-173b3bc055d7
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Date deposited: 28 Nov 2023 17:34
Last modified: 18 Mar 2024 04:16
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Contributors
Author:
Judy Richards
Author:
Judith Rankin
Author:
Ed Juszczak
Author:
Jon Dorling
Author:
William McGuire
Author:
Nicholas D. Embleton
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