Parker S G, Oliver P, Pennington M, Bond J, Jagger C, Enderby P M, Curless R, Chater T, Vanoli A, Fryer K, Cooper C, Julious S, Donaldson C, Dyer C, Wynn T, John A, Ross D
Sheffield Institute for Studies on Ageing, University of Sheffield, UK.
Health Technol Assess. 2009 Aug;13(39):1-143, iii-iv. doi: 10.3310/hta13390.
To test the hypotheses that older people and their informal carers are not disadvantaged by home-based rehabilitation (HBR) relative to day hospital rehabilitation (DHR) and that HBR is less costly.
Two-arm randomised controlled trial.
Four trusts in England providing both HBR and DHR.
Clinical staff reviewed consecutive referrals to identify subjects who were potentially suitable for randomisation according to the defined inclusion criteria.
Patients were randomised to receive either HBR or DHR.
The primary outcome measure was the Nottingham Extended Activities of Daily Living (NEADL) scale. Secondary outcome measures included the EuroQol 5 dimensions (EQ-5D), Hospital Anxiety and Depression Scale (HADS), Therapy Outcome Measures (TOMs), hospital admissions and the General Health Questionnaire (GHQ-30) for carers.
Overall, 89 subjects were randomised and 42 received rehabilitation in each arm of the trial. At the primary end point of 6 months there were 32 and 33 patients in the HBR and DHR arms respectively. Estimated mean scores on the NEADL scale at 6 months, after adjustment for baseline, were not significantly in favour of either HBR or DHR [DHR 30.78 (SD 15.01), HBR 32.11 (SD 16.89), p = 0.37; mean difference -2.139 (95% CI -6.870 to 2.592)]. Analysis of the non-inferiority of HBR over DHR using a 'non-inferiority' limit (10%) applied to the confidence interval estimates for the different outcome measures at 6 months' follow-up demonstrated non-inferiority for the NEADL scale, EQ-5D and HADS anxiety scale and some advantage for HBR on the HADS depression scale, of borderline statistical significance. Similar results were seen at 3 and 12 months' follow-up, with a statistically significant difference in the mean EQ-5D(index) score in favour of DHR at 3 months (p = 0.047). At the end of rehabilitation, a greater proportion of the DHR group showed a positive direction of change from their initial assessment with respect to therapist-rated clinical outcomes; however, a lower proportion of HBR patients showed a negative direction of change and, overall, median scores on the TOMs scales did not differ between the two groups. Fewer patients in the HBR group were admitted to hospital on any occasion over the 12-month observation period [18 (43%) versus 22 (52%)]; however, this difference was not statistically significant. The psychological well-being of patients' carers, measured at 3, 6 and 12 months, was unaffected by whether rehabilitation took place at day hospital or at home. As the primary outcome measure and EQ-5D(index) scores at 6 months showed no significant differences between the two arms of the trial, a cost-minimisation analysis was undertaken. Neither the public costs nor the total costs at the 6-month follow-up point (an average of 213 days' total follow-up) or the 12-month follow-up point (an average of 395 days' total follow-up) were significantly different between the groups.
Compared with DHR, providing rehabilitation in patients' own homes confers no particular disadvantage for patients and carers. The cost of providing HBR does not appear to be significantly different from that of providing DHR. Rehabilitation providers and purchasers need to consider the place of care in the light of local needs, to provide the benefits of both kinds of services. Caution is required when interpreting the results of the RCT because a large proportion of potentially eligible subjects were not recruited to the trial, the required sample size was not achieved and there was a relatively large loss to follow-up.
Current Controlled Trials ISRCTN71801032.
检验以下假设，即与日间医院康复（DHR）相比，老年人及其非正式照料者在家中进行康复（HBR）并无劣势，且HBR成本更低。
双臂随机对照试验。
英格兰提供HBR和DHR的四个信托机构。
临床工作人员对连续转诊病例进行审查，以根据既定纳入标准确定可能适合随机分组的受试者。
患者被随机分配接受HBR或DHR。
主要结局指标是诺丁汉扩展日常生活活动（NEADL）量表。次要结局指标包括欧洲五维健康量表（EQ-5D）、医院焦虑抑郁量表（HADS）、治疗结局指标（TOMs）、住院情况以及针对照料者的一般健康问卷（GHQ-30）。
总体而言，89名受试者被随机分组，试验的每组各有42人接受康复治疗。在6个月的主要终点时，HBR组和DHR组分别有32名和33名患者。在对基线进行调整后，6个月时NEADL量表的估计平均得分对HBR或DHR均无显著优势[DHR 30.78（标准差15.01），HBR 32.11（标准差16.89），p = 0.37；平均差值-2.139（95%置信区间-6.870至2.592）]。在6个月随访时，使用应用于不同结局指标置信区间估计的“非劣效性”界限（10%）分析HBR相对于DHR的非劣效性，结果表明NEADL量表、EQ-5D和HADS焦虑量表具有非劣效性，且HBR在HADS抑郁量表上有一定优势，具有边缘统计学意义。在3个月和12个月随访时也观察到类似结果，3个月时EQ-5D（指数）平均得分在统计学上有显著差异，有利于DHR（p = 0.047）。在康复结束时，DHR组中有更大比例的患者在治疗师评定的临床结局方面相对于初始评估呈现积极变化方向；然而，HBR患者中呈现消极变化方向的比例较低，总体而言，两组TOMs量表的中位数得分没有差异。在12个月观察期内，HBR组住院的患者更少[18例（43%）对22例（52%）]；然而，这种差异无统计学意义。在3个月、6个月和12个月时测量的患者照料者的心理健康状况不受康复是在日间医院还是在家中进行的影响。由于试验的两组在6个月时主要结局指标和EQ-5D（指数）得分无显著差异，因此进行了成本最小化分析。两组在6个月随访点（平均总随访213天）或12个月随访点（平均总随访395天）的公共成本和总成本均无显著差异。
与DHR相比，在患者家中提供康复对患者和照料者没有特别的劣势。提供HBR的成本似乎与提供DHR的成本没有显著差异。康复服务提供者和购买者需要根据当地需求考虑护理地点，以提供两种服务的益处。在解释随机对照试验结果时需要谨慎，因为很大一部分潜在符合条件的受试者未被纳入试验，未达到所需样本量，且随访失访相对较多。
当前对照试验ISRCTN71801032。
