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英国初级保健中抑郁症协作护理的临床疗效和成本效益(CADET):一项整群随机对照试验

Clinical effectiveness and cost-effectiveness of collaborative care for depression in UK primary care (CADET): a cluster randomised controlled trial.

作者信息

Richards David A, Bower Peter, Chew-Graham Carolyn, Gask Linda, Lovell Karina, Cape John, Pilling Stephen, Araya Ricardo, Kessler David, Barkham Michael, Bland J Martin, Gilbody Simon, Green Colin, Lewis Glyn, Manning Chris, Kontopantelis Evangelos, Hill Jacqueline J, Hughes-Morley Adwoa, Russell Abigail

机构信息

University of Exeter Medical School, Exeter, UK.

Centre for Primary Care, Institute of Population Health, University of Manchester, Manchester, UK.

出版信息

Health Technol Assess. 2016 Feb;20(14):1-192. doi: 10.3310/hta20140.

DOI:10.3310/hta20140
PMID:26910256
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4809468/
Abstract

BACKGROUND

Collaborative care is effective for depression management in the USA. There is little UK evidence on its clinical effectiveness and cost-effectiveness.

OBJECTIVE

To determine the clinical effectiveness and cost-effectiveness of collaborative care compared with usual care in the management of patients with moderate to severe depression.

DESIGN

Cluster randomised controlled trial.

SETTING

UK primary care practices (n = 51) in three UK primary care districts.

PARTICIPANTS

A total of 581 adults aged ≥ 18 years in general practice with a current International Classification of Diseases, Tenth Edition depressive episode, excluding acutely suicidal people, those with psychosis, bipolar disorder or low mood associated with bereavement, those whose primary presentation was substance abuse and those receiving psychological treatment.

INTERVENTIONS

Collaborative care: 14 weeks of 6-12 telephone contacts by care managers; mental health specialist supervision, including depression education, medication management, behavioural activation, relapse prevention and primary care liaison. Usual care was general practitioner standard practice.

MAIN OUTCOME MEASURES

Blinded researchers collected depression [Patient Health Questionnaire-9 (PHQ-9)], anxiety (General Anxiety Disorder-7) and quality of life (European Quality of Life-5 Dimensions three-level version), Short Form questionnaire-36 items) outcomes at 4, 12 and 36 months, satisfaction (Client Satisfaction Questionnaire-8) outcomes at 4 months and treatment and service use costs at 12 months.

RESULTS

In total, 276 and 305 participants were randomised to collaborative care and usual care respectively. Collaborative care participants had a mean depression score that was 1.33 PHQ-9 points lower [n = 230; 95% confidence interval (CI) 0.35 to 2.31; p = 0.009] than that of participants in usual care at 4 months and 1.36 PHQ-9 points lower (n = 275; 95% CI 0.07 to 2.64; p = 0.04) at 12 months after adjustment for baseline depression (effect size 0.28, 95% CI 0.01 to 0.52; odds ratio for recovery 1.88, 95% CI 1.28 to 2.75; number needed to treat 6.5). Quality of mental health but not physical health was significantly better for collaborative care at 4 months but not at 12 months. There was no difference for anxiety. Participants receiving collaborative care were significantly more satisfied with treatment. Differences between groups had disappeared at 36 months. Collaborative care had a mean cost of £272.50 per participant with similar health and social care service use between collaborative care and usual care. Collaborative care offered a mean incremental gain of 0.02 (95% CI -0.02 to 0.06) quality-adjusted life-years (QALYs) over 12 months at a mean incremental cost of £270.72 (95% CI -£202.98 to £886.04) and had an estimated mean cost per QALY of £14,248, which is below current UK willingness-to-pay thresholds. Sensitivity analyses including informal care costs indicated that collaborative care is expected to be less costly and more effective. The amount of participant behavioural activation was the only effect mediator.

CONCLUSIONS

Collaborative care improves depression up to 12 months after initiation of the intervention, is preferred by patients over usual care, offers health gains at a relatively low cost, is cost-effective compared with usual care and is mediated by patient activation. Supervision was by expert clinicians and of short duration and more intensive therapy may have improved outcomes. In addition, one participant requiring inpatient treatment incurred very significant costs and substantially inflated our cost per QALY estimate. Future work should test enhanced intervention content not collaborative care per se.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN32829227.

FUNDING

This project was funded by the Medical Research Council (MRC) (G0701013) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC-NIHR partnership.

摘要

背景

在美国,协作式照护对抑郁症管理有效。英国几乎没有关于其临床疗效和成本效益的证据。

目的

确定在中重度抑郁症患者管理中,协作式照护与常规照护相比的临床疗效和成本效益。

设计

整群随机对照试验。

设置

英国三个初级保健区的51家英国初级保健机构。

参与者

共有581名年龄≥18岁的成年人,来自全科医疗,患有当前国际疾病分类第十版抑郁发作,排除急性自杀者、患有精神病、双相情感障碍或与丧亲相关的情绪低落者、主要表现为药物滥用者以及正在接受心理治疗者。

干预措施

协作式照护:护理经理进行14周、每周6 - 12次电话联系;心理健康专家监督,包括抑郁症教育、药物管理、行为激活、预防复发和初级保健联络。常规照护为全科医生的标准诊疗。

主要结局指标

盲法研究人员在4个月、12个月和36个月时收集抑郁症(患者健康问卷 - 9 [PHQ - 9])、焦虑(广泛性焦虑障碍 - 7)和生活质量(欧洲生活质量五维度三级版本、简明健康调查问卷36项)结局,在4个月时收集满意度(客户满意度问卷 - 8)结局,在12个月时收集治疗及服务使用成本。

结果

总共276名和305名参与者分别被随机分配至协作式照护组和常规照护组。协作式照护组参与者在4个月时的平均抑郁评分比常规照护组参与者低1.33个PHQ - 9得分 [n = 230;95%置信区间(CI)0.35至2.31;p = 0.009],在调整基线抑郁后,12个月时低1.36个PHQ - 9得分(n = 275;95% CI 0.07至2.64;p = 0.04)(效应量0.28,95% CI 0.01至0.52;康复优势比1.88,95% CI 1.28至2.75;需治疗人数6.5)。4个月时协作式照护组的心理健康质量显著更好,但身体健康质量并非如此,12个月时则无差异。焦虑方面无差异。接受协作式照护的参与者对治疗的满意度显著更高。两组间差异在36个月时消失。协作式照护每位参与者的平均成本为272.50英镑,协作式照护组和常规照护组在健康和社会护理服务使用方面相似。协作式照护在12个月期间平均每增加一个质量调整生命年(QALY)的增益为0.02(95% CI -0.02至0.06),平均增量成本为270.72英镑(95% CI -202.98英镑至886.04英镑),估计每QALY的平均成本为14,248英镑,低于当前英国的支付意愿阈值。包括非正式护理成本的敏感性分析表明,协作式照护预计成本更低且更有效。参与者行为激活量是唯一的效应中介因素。

结论

协作式照护在干预开始后长达12个月可改善抑郁症,患者比常规照护更青睐,以相对低成本带来健康收益,与常规照护相比具有成本效益且由患者激活介导。监督由专家临床医生进行且持续时间短,更强化的治疗可能会改善结局。此外,一名需要住院治疗的参与者产生了非常高的成本,大幅抬高了我们每QALY估计成本。未来工作应测试强化干预内容而非协作式照护本身。

试验注册

当前受控试验ISRCTN32829227。

资助

本项目由医学研究理事会(MRC)(G0701013)资助,并由国家卫生研究院(NIHR)代表MRC - NIHR合作关系进行管理。

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