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针对患有常见精神障碍的病假员工的丹麦伊比试验:一项比较随机试验和真实世界数据的4期前瞻性研究。

The Danish Ibbis Trials for Sickness Absentees with Common Mental Disorders: A Phase 4 Prospective Study Comparing Randomized Trial and Real-World Data.

作者信息

Hoff Andreas, Bojesen Anders Bo, Falgaard Eplov Lene

机构信息

Copenhagen Research Unit for Recovery, Mental Health Services, Capital Region Denmark, Copenhagen University Hospital, Hans Bogbinders Allé3, 3. sal, 2300 København S, Denmark.

出版信息

Int J Integr Care. 2024 Jul 26;24(3):10. doi: 10.5334/ijic.7562. eCollection 2024 Jul-Sep.

DOI:10.5334/ijic.7562
PMID:39071746
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11276403/
Abstract

INTRODUCTION

In two randomized controlled trials (RCT) we tested the efficacy of a novel integrated vocational rehabilitation and mental healthcare intervention, coined INT, for sickness absentees with common mental disorders. The aim was to improve vocational outcomes compared to Service As Usual (SAU). Contrary to expectations, the delivered intervention caused worse outcomes within some diagnostic groups and some benefits in others. In this phase 4 study, we examined the effectiveness of the intervention in real-world practice.

METHOD

In this prospective intervention study, we allocated adult sickness absentees with either depression, anxiety, or adjustment disorder to receive INT in a real-world setting in a Danish Municipality. We compared the vocational outcomes of this group to a matched group who received INT as a part of the RCTs, after randomization to the intervention group herein. Primary outcome was return to work at any point within 12 months.

RESULTS

In the real-world group, 151 participants received INT during 2019. From the randomized trials, 302 matched participants who received INT between 2016-2018 were included. On the primary outcome - return to work within 12 months - the real-word group fared worse (48.3 vs 64.6 %, OR 0.54 [95%CI: 0.37-0.79], p = 0.001). Across most other vocational outcomes, a similar pattern of statistically significant poorer outcomes in the real-world group was observed: Lower number of weeks in work and lower proportion in work at 12 months (42.3% vs. 58.3% (p = 0.002)).

DISCUSSION

The real-word group showed significantly worse vocational outcomes. Like in many other studies of complex interventions, implementation was difficult in the original randomized trials and perhaps even more difficult in the less structured real-world setting. Since the intervention was less effective for some groups compared to SAU in the original trial, this negative effect may be even more pronounced in a real-world setting.

摘要

引言

在两项随机对照试验(RCT)中,我们测试了一种名为INT的新型综合职业康复与心理保健干预措施对患有常见精神障碍的病假员工的疗效。目的是与常规服务(SAU)相比,改善职业结局。与预期相反,所提供的干预措施在某些诊断组中导致了更差的结局,而在其他组中则带来了一些益处。在这项4期研究中,我们考察了该干预措施在实际应用中的效果。

方法

在这项前瞻性干预研究中,我们将患有抑郁症、焦虑症或适应障碍的成年病假员工分配到丹麦一个市镇的实际工作环境中接受INT干预。我们将该组的职业结局与在随机对照试验中被随机分配到干预组后接受INT的匹配组进行比较。主要结局是在12个月内的任何时间重返工作岗位。

结果

在实际应用组中,2019年有151名参与者接受了INT干预。从随机对照试验中,纳入了2016年至2018年期间接受INT干预的302名匹配参与者。在主要结局——12个月内重返工作岗位方面,实际应用组的情况更差(48.3%对64.6%,比值比0.54[95%置信区间:0.37 - 0.79],p = 0.001)。在大多数其他职业结局方面,实际应用组也呈现出类似的统计学上显著更差结局的模式:工作周数更少,12个月时工作比例更低(42.3%对58.3%(p = 0.002))。

讨论

实际应用组的职业结局明显更差。与许多其他复杂干预措施的研究一样,在最初的随机对照试验中实施干预很困难,而在结构较松散的实际工作环境中可能更困难。由于在最初的试验中,与常规服务相比,该干预措施对某些组的效果较差,这种负面影响在实际工作环境中可能会更加明显。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14ba/11276403/8dafc6ac0199/ijic-24-3-7562-g2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14ba/11276403/6217a1c6d375/ijic-24-3-7562-g1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14ba/11276403/8dafc6ac0199/ijic-24-3-7562-g2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14ba/11276403/6217a1c6d375/ijic-24-3-7562-g1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14ba/11276403/8dafc6ac0199/ijic-24-3-7562-g2.jpg

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本文引用的文献

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Scand J Work Environ Health. 2023 May 1;49(4):303-308. doi: 10.5271/sjweh.4084. Epub 2023 Mar 5.
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Integrated Mental Healthcare and Vocational Rehabilitation for People on Sick Leave with Anxiety or Depression: 24-Month Follow-up of the Randomized IBBIS Trial.综合心理保健和职业康复对请病假的焦虑或抑郁患者的疗效:随机 IBBIS 试验的 24 个月随访。
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Predictors of return to work for people on sick leave with common mental disorders: a systematic review and meta-analysis.常见精神障碍患者休病假后重返工作岗位的预测因素:系统评价和荟萃分析。
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