Core outcome sets for use in effectiveness trials involving people with bipolar and schizophrenia in a community-based setting (PARTNERS2): study protocol for the development of two core outcome sets
Core outcome sets for use in effectiveness trials involving people with bipolar and schizophrenia in a community-based setting (PARTNERS2): study protocol for the development of two core outcome sets
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DOI：
10.1186/s13063-015-0553-0
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发表时间：
2015-02-12
期刊：
影响因子：
2.5
通讯作者：
Calvert, Melanie
中科院分区：
文献类型：
--
作者：
Keeley, Thomas;Khan, Humera;Calvert, Melanie
背景：在普通人群中，双相情感障碍和精神分裂症的患病率分别为0.24%和1.4%。精神分裂症和躁郁症患者的预期寿命显著缩短，失业率增加，害怕耻辱导致自信心下降。核心结果集是一个研究领域内所有对照试验中应报告的项目的标准化集合。目前没有核心结果集可用于在有效性试验中使用，涉及双相或精神分裂症服务用户在社区setting.Methods管理：一个三步的方法是用来同时开发两个核心结果集，一个双相和精神分裂症。首先，将通过定性研究和试验数据库的系统检索编制一份全面的结局列表。焦点小组和一对一的采访将完成与服务用户，照顾者和医疗保健专业人员。第二，德尔菲研究将被用来减少列表的核心集。三轮德尔菲研究将要求服务用户对结果列表的相关性进行评分。在第二轮中，利益相关者只能看到他们所在小组的结果，而在第三轮中，利益相关者将按利益相关者小组查看所有利益相关者小组的结果。第三，将与利益攸关方举行协商一致会议，以确认将纳入核心数据集的成果。核心集的发展后，现有的措施进行系统的文献综述将允许建议如何衡量的核心成果，并表示偏好调查将探讨人们的偏好和估计权重的力量，包括核心set.Discussion的结果：一个核心成果集代表了最低的测量要求的研究领域。我们的目标是开发核心结果集，用于涉及在社区环境中管理的精神分裂症或双相情感障碍服务用户的研究。这将为更广泛的PARTNERS2研究目的和目标提供信息，即为诊断为双相情感障碍或精神分裂症的患者开发一种创新的基于初级护理的协作护理模式。
Background: In the general population the prevalence of bipolar and schizophrenia is 0.24% and 1.4% respectively. People with schizophrenia and bipolar disorder have a significantly reduced life expectancy, increased rates of unemployment and a fear of stigma leading to reduced self-confidence. A core outcome set is a standardised collection of items that should be reported in all controlled trials within a research area. There are currently no core outcome sets available for use in effectiveness trials involving bipolar or schizophrenia service users managed in a community setting.Methods: A three-step approach is to be used to concurrently develop two core outcome sets, one for bipolar and one for schizophrenia. First, a comprehensive list of outcomes will be compiled through qualitative research and systematic searching of trial databases. Focus groups and one-to-one interviews will be completed with service users, carers and healthcare professionals. Second, a Delphi study will be used to reduce the lists to a core set. The three-round Delphi study will ask service users to score the outcome list for relevance. In round two stakeholders will only see the results of their group, while in round three stakeholders will see the results of all stakeholder group by stakeholder group. Third, a consensus meeting with stakeholders will be used to confirm outcomes to be included in the core set. Following the development of the core set a systematic literature review of existing measures will allow recommendations for how the core outcomes should be measured and a stated preference survey will explore the strength of people's preferences and estimate weights for the outcomes that comprise the core set.Discussion: A core outcome set represents the minimum measurement requirement for a research area. We aim to develop core outcome sets for use in research involving service users with schizophrenia or bipolar managed in a community setting. This will inform the wider PARTNERS2 study aims and objectives of developing an innovative primary care-based model of collaborative care for people with a diagnosis of bipolar or schizophrenia.