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[支持康复患者的自主倡议(“新信条”)——非随机试验的长期效果]

[Supported own initiative of rehabilitation patients ("new credo") - longterm effects of the nonrandomized trial].

作者信息

Schramm S, Hüppe A, Jürgensen M, Deck R

机构信息

Institut für Sozialmedizin der Universität Lübeck.

出版信息

Rehabilitation (Stuttg). 2014 Oct;53(5):297-304. doi: 10.1055/s-0033-1358388. Epub 2014 Jan 7.

Abstract

OBJECTIVE

Our project is closely related to the previous study "Rehabilitation aftercare - a new credo for rehabilitation clinics"; the intensified aftercare-strategy was developed by an interdisciplinary group of health professionals and scientists for patients with chronic back pain. Main objective is the resumption and maintenance of regular physical activity in everyday life of pa-tients undergoing rehabilitation. The aim of our present study was to evaluate the long-term (24-month-follow-up) efficacy of the "New Credo" (inpatient medical rehabilitation+intensified aftercare=IG) as compared with usual care (inpatient medical rehabilitation=CG).

METHODOLOGY

We conducted a prospective controlled multicentre trial (IG: 3 clinics vs. CG: 3 clinics) with 4 points of measurement (T0: before and T1: after rehabilitation as well as T3: 12 and T4: 24 month after discharge). We enrolled rehabilitants with a primary diagnosis of chronic back pain (ICD-10: M51-54) who had given their consent. Exclusion criteria were mental and/or psychological impairments as well as surgery in the past 6 months. Primary Outcomes included restriction of social participation (IMET) and functional capacity (FFbH-R). Treatment effects were evaluated using analyses of variance and adjusting for differences between baseline -values; furthermore we calculated effect sizes (SMDInter, SMDIntra, ORs).

RESULTS

Complete data were available for 123 IG-rehabilitants and 299 CG-participants (Completer-Analysis, response: 52%). Regarding restriction in functional capacity in everyday life (FFbH-R) multivariate analysis confirmed a treatment*time interaction, the appropriate effect-sizes showed no significant effects (SMDInter and SMDIntra). With respect to long-term effects 24 months after discharge no significant effects were found for social participation, however. With respect to secondary outcomes there are no significant differences between the groups (SMDInter, ORs); in fact rehabilitants of both groups showed similar effects (SMDIntra) in most cases.

CONCLUSION

In summary our results doesn't confirm that the intensified aftercare-programme is able to improve longer-term effectiveness of inpatient orthopaedic rehabilitation up to 24 month.

摘要

目的

我们的项目与之前的研究“康复后续护理——康复诊所的新信条”密切相关;强化后续护理策略是由一组跨学科的健康专业人员和科学家为慢性背痛患者制定的。主要目标是使接受康复治疗的患者在日常生活中恢复并保持规律的体育活动。我们当前研究的目的是评估“新信条”(住院医疗康复+强化后续护理=干预组)与常规护理(住院医疗康复=对照组)相比的长期(24个月随访)疗效。

方法

我们进行了一项前瞻性对照多中心试验(干预组:3家诊所 vs. 对照组:3家诊所),有4个测量点(T0:康复前,T1:康复后,以及T3:出院后12个月和T4:出院后24个月)。我们纳入了主要诊断为慢性背痛(国际疾病分类第十版:M51 - 54)且已签署知情同意书的康复者。排除标准为精神和/或心理障碍以及过去6个月内进行过手术。主要结局包括社会参与受限(IMET)和功能能力(FFbH - R)。使用方差分析并调整基线值之间的差异来评估治疗效果;此外,我们计算了效应量(组间标准化均值差、组内标准化均值差、优势比)。

结果

123名干预组康复者和299名对照组参与者有完整数据(完全分析,应答率:52%)。关于日常生活中的功能能力受限(FFbH - R),多变量分析证实了治疗*时间交互作用,相应的效应量显示无显著影响(组间标准化均值差和组内标准化均值差)。然而,关于出院后24个月的长期影响,未发现社会参与有显著影响。关于次要结局,两组之间无显著差异(组间标准化均值差、优势比);事实上,两组康复者在大多数情况下显示出相似的效果(组内标准化均值差)。

结论

总之,我们的结果并未证实强化后续护理计划能够提高住院骨科康复长达24个月的长期有效性。

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