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Acupuncture for Depression: Exploring Model Validity and the Related Issue of Credibility in the Context of Designing a Pragmatic Trial

机译:针刺治疗抑郁症:在设计实用性试验的背景下探讨模型的有效性和可信度的相关问题

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SUMMARY Introduction: Evaluating care that is not credible to its practitioners or patients will result in a gap between evidence and practice and the potential value, or harm, of the intervention may be underestimated. Our aim was to develop a pragmatic trial that would have better model validity and credibility than trials to date in this clinical area. Methods: In‐depth interviews; a nominal consensus technique and five arm pilot trial conducted in UK primary care using counseling and usual general practitioner (GP) care as comparisons for acupuncture. Findings: Patients with long standing, severe illness that had not responded, or partially responded to conventional treatments may be interested in using acupuncture and participating in a trial. Using a database method to recruit, pilot trial patients were mostly severely depressed (87.5%); chronically ill (60% with 3+ previous episodes), with high levels of comorbidity, and medication use. Acupuncture was as credible to pilot trial participants as usual GP care and more credible than counseling: most patients (62.5%) preferred to be allocated to acupuncture, rating it more highly at baseline than counseling or usual GP care as potentially able to benefit their depression ( P = 0.002). Disparities were identified in the working models of acupuncturists and counselors that suggest inherent differences between interventions in terms of the process and intended potential outcomes of therapy, as well as the interaction between patients and therapists. Conclusion: The Medical Research Council (MRC) framework with its phased, mixed method approach has helped to develop research that has better model validity than trials to date in this field. The next phase of research will need to involve acupuncture and counseling practitioners to help researchers to develop realistic and credible care packages for a full‐scale trial, where patients are likely to be severely and chronically ill.
机译:简介简介:评价对其从业者或患者不可信的护理会导致证据与实践之间存在差距,并且可能会低估干预的潜在价值或危害。我们的目的是开发一个实用的试验,其模型有效性和可信度比迄今为止在该临床领域的试验要好。方法:深入访谈;在英国的初级保健中使用咨询和普通全科医生(GP)护理进行的一项名义上的共识技术和五臂试点试验,作为针灸的比较。结果:长期站立,对传统疗法无反应或部分反应的严重疾病的患者可能对使用针灸并参加试验感兴趣。使用数据库方法招募的试点患者大多严重抑郁(87.5%);慢性病(60%的患者有3次以上发作),合并症和药物治疗水平很高。针灸对试点参与者的信度与常规GP护理一样可信,并且比咨询更可信:大多数患者(62.5%)倾向于分配针灸,在基线对针灸的评分高于咨询或常规GP护理,因为它可能使他们的抑郁症受益(P = 0.002)。在针灸师和咨询师的工作模型中发现了差异,这些差异表明干预在过程和预期的潜在治疗效果以及患者与治疗师之间的相互作用方面存在内在差异。结论:医学研究理事会(MRC)框架及其分阶段的混合方法方法已帮助开发了比该领域迄今为止的试验更具模型效度的研究。下一阶段的研究将需要针灸和咨询从业人员的参与,以帮助研究人员针对现实世界中可能患有重病和慢性病的全面研究开发切实可行的护理方案。

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