采用混合方法制定正畸试验核心结局指标集：一项多中心研究方案
Development of a core outcome set for orthodontic trials using a mixed-methods approach: protocol for a multicentre study.
作者信息
Tsichlaki Aliki, O'Brien Kevin, Johal Ama, Marshman Zoe, Benson Philip, Colonio Salazar Fiorella B, Fleming Padhraig S
机构信息
Department of Orthodontics, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, E1 1BB, UK.
Division of Dentistry, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, M13 9PL, UK.
出版信息
Trials. 2017 Aug 4;18(1):366. doi: 10.1186/s13063-017-2098-x.
BACKGROUND
Orthodontic treatment is commonly undertaken in young people, with over 40% of children in the UK needing treatment and currently one third having treatment, at a cost to the National Health Service in England and Wales of £273 million each year. Most current research about orthodontic care does not consider what patients truly feel about, or want, from treatment, and a diverse range of outcomes is being used with little consistency between studies. This study aims to address these problems, using established methodology to develop a core outcome set for use in future clinical trials of orthodontic interventions in children and young people.
METHODS/DESIGN: This is a mixed-methods study incorporating four distinct stages. The first stage will include a scoping review of the scientific literature to identify primary and secondary outcome measures that have been used in previous orthodontic clinical trials. The second stage will involve qualitative interviews and focus groups with orthodontic patients aged 10 to 16 years to determine what outcomes are important to them. The outcomes elicited from these two stages will inform the third stage of the study in which a long-list of outcomes will be ranked in terms of importance using electronic Delphi surveys involving clinicians and patients. The final stage of the study will involve face-to-face consensus meetings with all stakeholders to discuss and agree on the outcome measures that should be included in the final core outcome set.
DISCUSSION
This research will help to inform patients, parents, clinicians and commissioners about outcomes that are important to young people undergoing orthodontic treatment. Adoption of the core outcome set in future clinical trials of orthodontic treatment will make it easier for results to be compared, contrasted and combined. This should translate into improved decision-making by all stakeholders involved.
TRIAL REGISTRATION
The project has been registered on the Core Outcome Measures in Effectiveness Trials ( COMET ) website, January 2016.
背景
正畸治疗通常在年轻人中进行，英国超过40%的儿童需要治疗，目前有三分之一正在接受治疗，每年给英格兰和威尔士的国民医疗服务体系造成2.73亿英镑的费用。目前大多数关于正畸护理的研究没有考虑患者对治疗的真实感受或期望，并且使用了各种各样的结果指标，研究之间几乎没有一致性。本研究旨在解决这些问题，采用既定方法制定一个核心结局指标集，用于未来儿童和青少年正畸干预的临床试验。
方法/设计：这是一项混合方法研究，包括四个不同阶段。第一阶段将包括对科学文献进行范围综述，以确定先前正畸临床试验中使用的主要和次要结局指标。第二阶段将对10至16岁的正畸患者进行定性访谈和焦点小组讨论，以确定对他们来说重要的结局。这两个阶段得出的结果将为研究的第三阶段提供信息，在该阶段，将使用涉及临床医生和患者的电子德尔菲调查，根据重要性对一长串结局进行排序。研究的最后阶段将包括与所有利益相关者举行面对面的共识会议，以讨论并就最终核心结局指标集中应包括的结局指标达成一致。
讨论
这项研究将有助于让患者、家长、临床医生和医疗服务提供者了解对接受正畸治疗的年轻人来说重要的结局。在未来的正畸治疗临床试验中采用核心结局指标集将使结果更容易进行比较、对比和整合。这应该会转化为所有相关利益者更好的决策。
试验注册
该项目已于2016年1月在有效性试验核心结局指标（COMET）网站上注册。
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