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Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study--a mixed methods study.最大化健康研究中定性研究与随机对照试验相结合的价值:试验中的定性研究(QUART)——一项混合方法研究。
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The influence of patients' preference/attitude towards psychotherapy and antidepressant medication on the treatment of major depressive disorder.患者对心理治疗和抗抑郁药物治疗的偏好/态度对重度抑郁症治疗的影响。
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一项针对对一种抗抑郁药无反应的人群进行的第二种抗抑郁药试验中嵌入式定性研究的价值:了解患者和全科医生的观点。

The value of an embedded qualitative study in a trial of a second antidepressant for people who had not responded to one antidepressant: understanding the perspectives of patients and general practitioners.

作者信息

Chew-Graham Carolyn A, Shepherd Thomas, Burroughs Heather, Dixon Katie, Kessler David

机构信息

Research Institute, Primary Care and Health Sciences, Keele University, Newcastle, Staffs, ST5 5BG, UK.

Centre for Academic Primary Care, Oakfield House, Oakfield Grove, Clifton, Bristol, BS8 2BN, UK.

出版信息

BMC Fam Pract. 2018 Dec 14;19(1):197. doi: 10.1186/s12875-018-0877-4.

DOI:10.1186/s12875-018-0877-4
PMID:30547766
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6293563/
Abstract

BACKGROUND

Depression is the leading cause of disability worldwide, and is a major contributor to the overall global burden of disease. The number of prescriptions for antidepressants has risen dramatically in recent years yet up to 50% of patients who are treated for depression with antidepressants do not report feeling better as a result of treatment, and do not show the desired improvement on depression measures. We report a qualitative study embedded in a trial of second antidepressant for people who had not responded to one antidepressant, exploring the acceptability of a combination of antidepressants from the perspectives of both patients and practitioners, together with experiences of participating in a clinical trial.

METHODS

A qualitative study embedded in a randomized controlled trial investigating the effectiveness and cost-effectiveness of combining mirtazapine with Serotonin-Noradrenaline Reuptake Inhibitor (SNRI) or Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants versus SNRI or SSRI therapy alone (the MIR trial). 59 interviews were conducted with people who declined to participate in the trial, people who completed the study and people who withdrew from the intervention, and 16 general practitioners.

RESULTS

Across the data-sets, four main themes were identified: the hard work of managing depression, uncertainties over the value of a second antidepressant, help-seeking at a point of crisis, and attainment and maintenance of a hard-won equilibrium.

CONCLUSIONS

Exploring reasons for declining to participate in a trial of a second antidepressant in people who had not responded to one antidepressant suggests that people who are already taking one antidepressant may be reluctant to take a second, being wary of possible side-effects, but also being unconvinced of the logic behind such a combination. In addition, people describe being in a state of equilibrium and reluctant to make a change, reflecting that this equilibrium is 'hard-won' and they are unwilling to risk disturbing this. This makes some people reluctant to enrol in a clinical trial. Understanding a patient's view on medication is important for GPs when discussing antidepressants.

TRIAL REGISTRATION

MIR Trial Registration: ISRCTN 06653773 .

摘要

背景

抑郁症是全球致残的主要原因,也是全球疾病总负担的主要促成因素。近年来,抗抑郁药的处方数量急剧上升,但接受抗抑郁药治疗的抑郁症患者中,高达50%的人表示治疗后感觉并未好转,在抑郁症测量指标上也未显示出预期的改善。我们报告了一项定性研究,该研究嵌入了一项针对对一种抗抑郁药无反应的人群进行的第二种抗抑郁药试验,从患者和从业者的角度探讨联合使用抗抑郁药的可接受性,以及参与临床试验的经历。

方法

一项定性研究嵌入了一项随机对照试验,该试验调查米氮平与5-羟色胺-去甲肾上腺素再摄取抑制剂(SNRI)或选择性5-羟色胺再摄取抑制剂(SSRI)类抗抑郁药联合使用相对于单独使用SNRI或SSRI疗法的有效性和成本效益(MIR试验)。对拒绝参与试验的人、完成研究的人和退出干预的人以及16名全科医生进行了59次访谈。

结果

在所有数据集中,确定了四个主要主题:应对抑郁症的艰难过程、第二种抗抑郁药价值的不确定性、在危机时刻寻求帮助以及获得并维持来之不易的平衡。

结论

探究对一种抗抑郁药无反应的人群拒绝参与第二种抗抑郁药试验的原因表明,已经在服用一种抗抑郁药的人可能不愿服用第二种,他们担心可能的副作用,同时也不相信这种联合用药背后的逻辑。此外,人们表示处于一种平衡状态,不愿做出改变,这反映出这种平衡是“来之不易的”,他们不愿意冒险打破这种平衡。这使得一些人不愿参加临床试验。在讨论抗抑郁药时,了解患者对药物治疗的看法对全科医生很重要。

试验注册

MIR试验注册:ISRCTN 06653773 。