Clinical trials in neonates: How to optimise informed consent and decision making? A European Delphi survey of parent representatives and clinicians
| Autor: | Nicole Thiele, Virginia Neyro, Valery Elie, Evelyne Jacqz-Aigrain |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Adult
Male Parents medicine.medical_specialty Decision Making MEDLINE Delphi method lcsh:Medicine 03 medical and health sciences 0302 clinical medicine Informed consent 030225 pediatrics Physicians Surveys and Questionnaires medicine Humans 030212 general & internal medicine Decision-making lcsh:Science Third-Party Consent Clinical Trials as Topic Multidisciplinary Informed Consent lcsh:R Infant Newborn Middle Aged Reference Standards Research Personnel Clinical trial Europe Family medicine Scale (social sciences) Female lcsh:Q Parental consent Neonatology Psychology Inclusion (education) |
| Zdroj: | PLoS ONE, Vol 13, Iss 6, p e0198097 (2018) |
| ISSN: | 1932-6203 |
| Popis: | Objectives Parental consent for the participation of their neonate in neonatal research is influenced by the quality of the information delivered and the interaction between parents and investigators. Failure to provide important information may lead to difficulties in the decision making process of parents. This Delphi survey aims to establish a consensus between parent representatives of neonatal associations and healthcare professionals concerning the information deemed essential by both parties in order to improve the recruitment of neonates into clinical trials. Method This study was conducted in Europe among parent representatives and healthcare professionals. In this 3-phase study, 96 items were defined by the Scientific Committee (CS), composed of 11 clinicians (from 8 countries) and 1 parent representative of the European network of neonatal associations. Then the Committee of Experts (CE) composed of 16 clinicians were matched by country with 16 national parent representatives and evaluated these items in two rounds. The importance of each item was evaluated by each member of the CE on a scale between 1 and 9 based on their personal experience. Results Fifty eight items reached the second and final level of consensus. In contrast to clinicians, parent representatives preferred to be informed about the study by the physician in charge of their child. They also favoured additional support during the informed consent process and stated that both parents need to agree and sign. Conclusion The set of 58 items on which parents and clinicians reached consensus will be helpful to healthcare professionals seeking parental consent for the inclusion of a neonate in a clinical trial. Providing parents with information about the trial by the investigator in the presence of the patient’s neonatologist, developing closer contacts with parents and informing them of the available support by parents associations may be helpful for parents. |
| Databáze: | OpenAIRE |
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