Huxley C, Achten J, Costa M L, Griffiths F, Griffin X L
University of Warwick, Warwick Medical School, Social Science and Systems in Health, Coventry, CV4 7AL, UK.
University of Oxford, NDORMS, Kadoorie Centre, Level 3 John Radcliffe Hospital, Oxford, OX3 9DU, UK.
Bone Joint Res. 2016 Oct;5(10):444-452. doi: 10.1302/2046-3758.510.BJR-2015-0008.R1.
The annual incidence of hip fracture is 620 000 in the European Union. The cost of this clinical problem has been estimated at 1.75 million disability-adjusted life years lost, equating to 1.4% of the total healthcare burden in established market economies. Recent guidance from The National Institute for Health and Clinical Excellence (NICE) states that research into the clinical and cost effectiveness of total hip arthroplasty (THA) as a treatment for hip fracture is a priority. We asked the question: can a trial investigating THA for hip fracture currently be delivered in the NHS?
We performed a contemporaneous process evaluation that provides a context for the interpretation of the findings of WHiTE Two - a randomised study of THA for hip fracture. We developed a mixed methods approach to situate the trial centre within the context of wider United Kingdom clinical practice. We focused on fidelity, implementation, acceptability and feasibility of both the trial processes and interventions to stakeholder groups, such as healthcare providers and patients.
We have shown that patients are willing to participate in this type of research and that surgeons value being part of a team that has a strong research ethos. However, surgical practice does not currently reflect NICE guidance. Current models of service delivery for hip fractures are unlikely to be able to provide timely total hip arthroplasty for suitable patients.
Further observational research should be conducted to define the population of interest before future interventional studies are performed.Cite this article: C. Huxley, J. Achten, M. L. Costa, F. Griffiths, X. L. Griffin. A process evaluation of the WHiTE Two trial comparing total hip artroplasty with and without dual mobility component in the treatment of displaced intracapsular fractures of the proximal femur: Can a trial investigating total hip arthroplasty for hip fracture be delivered in the NHS? Bone Joint Res 2016;5:444-452. DOI: 10.1302/2046-3758.510.BJR-2015-0008.R1.
在欧盟，髋部骨折的年发病率为62万例。据估计，这一临床问题导致175万个伤残调整生命年的损失，相当于发达市场经济体总医疗负担的1.4%。英国国家卫生与临床优化研究所（NICE）近期发布的指南指出，将全髋关节置换术（THA）作为髋部骨折治疗方法的临床及成本效益研究是一项优先事项。我们提出了一个问题：目前在英国国民健康服务体系（NHS）中能否开展一项针对髋部骨折的THA试验？
我们进行了一项同期过程评估，为解读WHiTE Two（一项关于THA治疗髋部骨折的随机研究）的结果提供背景。我们采用了一种混合方法，将试验中心置于更广泛的英国临床实践背景中。我们关注试验过程和干预措施对利益相关者群体（如医疗服务提供者和患者）的保真度、实施情况、可接受性和可行性。
我们发现患者愿意参与此类研究，并且外科医生重视成为具有强烈研究精神的团队的一员。然而，目前的外科实践并未体现NICE指南。当前髋部骨折的服务提供模式不太可能为合适的患者及时提供全髋关节置换术。
在未来进行干预性研究之前，应开展进一步的观察性研究以确定目标人群。引用本文：C. 赫胥黎、J. 阿兴、M. L. 科斯塔、F. 格里菲思、X. L. 格里芬。一项对WHiTE Two试验的过程评估，该试验比较了有和没有双动组件的全髋关节置换术治疗股骨近端移位囊内骨折的效果：在英国国民健康服务体系中能否开展一项针对髋部骨折的全髋关节置换术试验？《骨关节研究》2016年；5：444 - 452。DOI：10.1302/2046 - 3758.510.BJR - 2015 - 0008.R1。
