Core Outcome Domains for Clinical Trials on Somatic Symptom Disorder, Bodily Distress Disorder, and Functional Somatic Syndromes: European Network on Somatic Symptom Disorders Recommendations
Core Outcome Domains for Clinical Trials on Somatic Symptom Disorder, Bodily Distress Disorder, and Functional Somatic Syndromes: European Network on Somatic Symptom Disorders Recommendations
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DOI：
10.1097/psy.0000000000000502
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发表时间：
2017-11-01
影响因子：
3.3
通讯作者：
van der Feltz-Cornelis, Christina
中科院分区：
文献类型：
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作者：
Rief, Winfried;Burton, Chris;van der Feltz-Cornelis, Christina
目的协调临床试验中的核心结果域，便于数据的比较和汇集，简化研究项目的准备和审查以及治疗的风险和收益的比较。因此，我们对躯体症状障碍、躯体窘迫障碍和功能性躯体综合征的干预的有效性和有效性的临床试验中应该考虑的核心结果领域提出了建议。方法由该领域的20多名专家组成的欧洲躯体症状障碍网络小组在汉堡召开了两次会议，讨论躯体症状障碍、躯体窘迫障碍和功能性躯体综合征的评估和干预研究问题。结果在临床试验中定义确定方法时，应考虑以下核心领域：a)躯体症状障碍/躯体窘迫障碍、相关功能性躯体综合征和合并精神障碍的分类(使用结构化临床访谈)、症状持续时间、医疗发病率和既往治疗；b)躯体症状的位置、强度和干扰；c)相关的心理行为特征和生物标志物；d)疾病后果(生活质量、残疾、医疗利用、医疗费用；e)总体改善和治疗满意度；和f)不良反应。结论建议的标准旨在提高临床试验的协同作用，并在比较不同的治疗方法时便于决策。这些建议不应导致缺乏灵活性的指导方针，而应增加这一领域各调查的一致性。
Objective The harmonization of core outcome domains in clinical trials facilitates comparison and pooling of data, and simplifies the preparation and review of research projects and comparison of risks and benefits of treatments. Therefore, we provide recommendations for the core outcome domains that should be considered in clinical trials on the efficacy and effectiveness of interventions for somatic symptom disorder, bodily distress disorder, and functional somatic syndromes.Methods The European Network on Somatic Symptom Disorders group of more than 20 experts in the field met twice in Hamburg to discuss issues of assessment and intervention research in somatic symptom disorder, bodily distress disorder, and functional somatic syndromes. The consensus meetings identified core outcome domains that should be considered in clinical trials evaluating treatments for somatic symptom disorder and associated functional somatic syndromes.Results The following core domains should be considered when defining ascertainment methods in clinical trials: a) classification of somatic symptom disorder/bodily distress disorder, associated functional somatic syndromes, and comorbid mental disorders (using structured clinical interviews), duration of symptoms, medical morbidity, and prior treatments; b) location, intensity, and interference of somatic symptoms; c) associated psychobehavioral features and biological markers; d) illness consequences (quality of life, disability, health care utilization, health care costs; e) global improvement and treatment satisfaction; and f) unwanted negative effects.Conclusions The proposed criteria are intended to improve synergies of clinical trials and to facilitate decision making when comparing different treatment approaches. These recommendations should not result in inflexible guidelines, but increase consistency across investigations in this field.