在澳大利亚六家公立医院的产前诊所进行的一项随机对照试验会产生哪些更广泛的影响和价值？使用评估转化性健康研究影响的框架进行影响评估。
What are the broader impacts and value from a randomised controlled trial conducted in six public hospital antenatal clinics in Australia? An impact assessment using the Framework to Assess the Impact from Translational health research.
作者信息
Elvidge Elissa, Murphy Vanessa E, Rao Melanie, Gibson Peter G, McLaughlin Karen, Robijn Annelies, Jensen Megan E, Callaway Leonie Kaye, Attia John, Hensley Michael, Giles Warwick, Peek Michael, Barrett Helen, Seeho Sean, Mattes Joerg, Abbott Alistair, Bisits Andrew, McCaffery Kirsten, Colditz Paul B, Searles Andrew, Ramanathan Shanthi Ann
机构信息
School of Medicine and Public Health, College of Health, Medicine and Wellbeing, University of Newcastle, Callaghan, New South Wales, Australia.
Asthma and Breathing Research Program, Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.
出版信息
BMJ Open. 2025 Mar 26;15(3):e082795. doi: 10.1136/bmjopen-2023-082795.
OBJECTIVES
The Breathing for Life Trial (BLT) was a multicentre randomised controlled trial testing the hypothesis that a fractional exhaled nitric oxide-based intervention to guide asthma therapy in pregnancy improves perinatal outcomes. While BLT was negative based on selected outcomes, the conduct of the trial over 7 years showed potential for assessing the broader research impacts and returns on investment in BLT. The aim of this study was to retrospectively assess and report on the impact and value of BLT to show accountability for the research investment in what was deemed a 'negative' trial.
METHODS
The Framework to Assess the Impact from Translational health research (FAIT) was selected as the preferred method. FAIT combines three validated methods, including a modified Payback framework, an economic analysis of return on investment and a narrative account of the impact generated from the research. Data collection was done via document analysis of BLT administrative and research records and review of relevant websites/databases.
RESULTS
BLT delivered a return on investment of $6.7 million in leveraged grants, fellowships and consultancies and conservatively returned $2.44 for every dollar invested. The research trained and upskilled 18 midwives and obstetricians in evidence-based asthma management in pregnancy and improved research capability of six PhD students. Specialised equipment purchased by BLT is now being repurposed to undertake other research in regional Australia, saving further research investment. Of the 1200 mothers who were part of BLT, 508 now have written asthma plans, 268 had a clinically significant improvement in their asthma control score and the proportion who improved their asthma plan knowledge increased by 58 percentage points from 12 to 70%.
CONCLUSION
This case example in the developing field of impact assessment illustrates how researchers can use evidence to demonstrate and report more broadly on the impact of and returns on research investment in a clinical trial.
TRIAL REGISTRATION NUMBER
ACTRN12613000202763; Post results.
目的
“生命呼吸试验”（BLT）是一项多中心随机对照试验，旨在验证基于呼出一氧化氮分数的干预措施指导孕期哮喘治疗可改善围产期结局这一假设。尽管基于选定结局，BLT试验结果为阴性，但该试验历时7年的开展过程显示出评估BLT更广泛研究影响和投资回报的潜力。本研究的目的是回顾性评估并报告BLT的影响和价值，以表明对这项被视为“阴性”试验的研究投资的责任。
方法
选择评估转化性健康研究影响的框架（FAIT）作为首选方法。FAIT结合了三种经过验证的方法，包括改良的投资回收期框架、投资回报率的经济分析以及对研究产生影响的叙述性描述。数据收集通过对BLT行政和研究记录的文档分析以及对相关网站/数据库的审查来完成。
结果
BLT在杠杆资助、奖学金和咨询方面实现了670万美元的投资回报，保守估计每投资1美元可回报2.44美元。该研究对18名助产士和产科医生进行了孕期循证哮喘管理方面的培训并提升了他们的技能，还提高了6名博士生的研究能力。BLT购买的专业设备现正被重新用于澳大利亚地区的其他研究，节省了更多研究投资。参与BLT的1200名母亲中，508人现在有了书面哮喘计划，268人的哮喘控制评分有了临床上的显著改善，哮喘计划知识得到改善的比例从12%提高到70%，增加了58个百分点。
结论
这个在影响评估发展领域的案例说明了研究人员如何利用证据更广泛地展示和报告临床试验中研究投资的影响和回报。
试验注册号
ACTRN12613000202763；结果公布后。
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