“我们知道这完全是随机的事情”：父母参与新生儿试验的经历。

'We knew it was a totally at random thing': parents' experiences of being part of a neonatal trial.

作者信息

Harvey Merryl, Nongena Phumza, Edwards David, Redshaw Maggie

机构信息

Centre for the Developing Brain, Division of Imaging and Biomedical Engineering, King's College, London, UK.

National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Old Road, Oxford, OX3 7LF, UK.

出版信息

Trials. 2017 Aug 1;18(1):361. doi: 10.1186/s13063-017-2112-3.

DOI:10.1186/s13063-017-2112-3

PMID:28764800

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5539623/

Abstract

BACKGROUND

Studies exploring parents' trial experiences generally relate to their understanding of the consent process and the development of researcher strategies to facilitate recruitment and retention. The aim was to better understand parents' experience of being part of a trial at the time and their perceptions of trial participation in retrospect.

METHODS

Data were collected in a number of ways: from recorded discussions between parents and clinicians about the MRI or ultrasound, in open-text responses to questionnaires and in qualitative interviews at 1 and 2 years after participation. Thematic analysis was undertaken using NVivo10.

RESULTS

Key themes identified were 'deciding to take part', with subthemes associated with 'benefitting self', 'benefitting others' and 'being prepared'; 'the randomisation process' with subthemes relating to 'acceptance' and 'understanding' and 'actual engagement' with subthemes of 'practicalities' and 'care from responsive staff'.

CONCLUSION

Parents' perspectives on the trial and the processes and information received reflect their understanding and experience of the trial and the value of parent-friendly information-giving about participation, randomisation and follow-up. The practical and logistical points raised confirm the key issues and parents' need for sensitive care and support in the course of a trial. Looking back, almost all parents were positive about their experience and felt that the family had benefitted from participation in the trial and follow-up studies, even when the developmental outcomes were poor.

TRIAL REGISTRATION

ClinicalTrials.gov, ID: NCT01049594. https://clinicaltrials.gov/ct2/show/NCT01049594 . Registered on 13 January 2010. EudraCT: EudraCT: 2009-011602-42. https://www.clinicaltrialsregister.eu/ .

摘要

背景

探索父母试验经历的研究通常涉及他们对同意过程的理解以及研究人员为促进招募和留住参与者所制定的策略。目的是更好地了解父母当时参与试验的经历以及他们对试验参与的回顾性看法。

方法

通过多种方式收集数据：从父母与临床医生关于磁共振成像（MRI）或超声检查的记录讨论、对问卷的开放式文本回复以及参与后1年和2年的定性访谈中收集。使用NVivo10进行主题分析。

结果

确定的关键主题包括“决定参与”，其相关子主题有“使自己受益”“使他人受益”和“做好准备”；“随机分组过程”，其相关子主题有“接受”和“理解”；以及“实际参与”，其相关子主题有“实际操作”和“来自反应迅速的工作人员的关怀”。

结论

父母对试验以及所获得的过程和信息的看法反映了他们对试验的理解和经历，以及提供对父母友好的关于参与、随机分组和随访信息的价值。提出的实际和后勤方面的要点证实了关键问题以及父母在试验过程中对体贴关怀和支持的需求。回顾过去，几乎所有父母对他们的经历都持积极态度，并认为家庭从参与试验和后续研究中受益，即使发育结果不佳。

试验注册

ClinicalTrials.gov，标识符：NCT01049594。https://clinicaltrials.gov/ct2/show/NCT01049594 。于2010年1月13日注册。欧盟临床试验注册数据库（EudraCT）：EudraCT：2009 - 011602 - 42。https://www.clinicaltrialsregister.eu/ 。