Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership - the PRioRiTy (Prioritising Recruitment in Randomised Trials) study

Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership - the PRioRiTy (Prioritising Recruitment in Randomised Trials) study
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DOI:
10.1186/s13063-018-2544-4
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发表时间:
2018-03-01
期刊:
影响因子:
2.5
通讯作者:
Devane, Declan
Devane, Declan
中科院分区:
医学4区
文献类型:
--
作者:
Healy, Patricia;Galvin, Sandra;Devane, Declan

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背景:尽管存在随机试验招募不足的问题,但几乎没有证据可以指导研究人员决定如何有效地招募人员参加试验。 PRioRiTy 研究旨在确定研究中尚未解答的重要试验招募问题并确定其优先顺序。 PRioRiTy 研究 - 优先设定伙伴关系 (PSP) 包括参与随机试验或代表随机试验指导委员会参与者的公众、具有招募随机试验经验的卫生专业人员和研究人员、设计、实施、分析或报告随机试验的人员以及具有随机试验方法经验的人员。方法:该伙伴关系得到了 James Lind Alliance 的协助,涉及八个阶段:(i) 在试验方法中确定一个独特的、相关的优先领域; (ii) 建立指导小组 (iii) 确定合作伙伴和利益相关者并与他们合作; (iv) 制定一份初步的不确定性清单; (v) 将不确定性整理成研究问题; (vi) 确认研究问题是当前招聘的挑战; (vii) 入围问题和 (viii) 通过面对面研讨会确定最终优先顺序。 结果:共有 790 名调查受访者对 6 个问题给出了 1693 个开放文本答案,从中确定了 1880 个潜在的研究问题。合并重复项后,问题数量减少到 496 个。问题进一步合并,由少于 15 人和/或 7 个利益相关者群体中少于 6 个提交的问题被排除在下一轮优先级排序之外,从而产生 31 个独特的研究问题。在检查相关的最新研究证据后,所有 31 个问题均被确认为未解答。面对面研讨会上对 10 个最优先的问题进行了排名。排名第一的问题是“随机试验如何成为常规护理的一部分并最好地利用当前的临床护理途径?”排名前 10 的研究问题可在 www.priorityresearch.ie 上查看。 结论:优先问题要求集体关注将试验正常化作为临床护理的一部分,加强沟通,解决参与方面的障碍、促成因素和激励因素,并探索公众更多地参与研究过程。
Background: Despite the problem of inadequate recruitment to randomised trials, there is little evidence to guide researchers on decisions about how people are effectively recruited to take part in trials. The PRioRiTy study aimed to identify and prioritise important unanswered trial recruitment questions for research. The PRioRiTy study - Priority Setting Partnership (PSP) included members of the public approached to take part in a randomised trial or who have represented participants on randomised trial steering committees, health professionals and research staff with experience of recruiting to randomised trials, people who have designed, conducted, analysed or reported on randomised trials and people with experience of randomised trials methodology.Methods: This partnership was aided by the James Lind Alliance and involved eight stages: (i) identifying a unique, relevant prioritisation area within trial methodology; (ii) establishing a steering group (iii) identifying and engaging with partners and stakeholders; (iv) formulating an initial list of uncertainties; (v) collating the uncertainties into research questions; (vi) confirming that the questions for research are a current recruitment challenge; (vii) shortlisting questions and (viii) final prioritisation through a face-to-face workshop.Results: A total of 790 survey respondents yielded 1693 open-text answers to 6 questions, from which 1880 potential questions for research were identified. After merging duplicates, the number of questions was reduced to 496. Questions were combined further, and those that were submitted by fewer than 15 people and/or fewer than 6 of the 7 stakeholder groups were excluded from the next round of prioritisation resulting in 31 unique questions for research. All 31 questions were confirmed as being unanswered after checking relevant, up-to-date research evidence. The 10 highest priority questions were ranked at a face-to-face workshop. The number 1 ranked question was "How can randomised trials become part of routine care and best utilise current clinical care pathways?" The top 10 research questions can be viewed at www.priorityresearch.ie.Conclusion: The prioritised questions call for a collective focus on normalising trials as part of clinical care, enhancing communication, addressing barriers, enablers and motivators around participation and exploring greater public involvement in the research process.