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A randomised controlled trial of hospital-based case management to improve colorectal cancer patients’ health-related quality of life and evaluations of care

机译:一项基于医院病例管理的随机对照试验,旨在改善结直肠癌患者健康相关的生活质量和护理评估

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Objective To analyse the effectiveness of hospital-based case management (CM) in terms of patient-reported outcomes. Design Randomised controlled trial allocating participants 1?:?1 to either a CM intervention or a control group. Allocation status was evident to participants and case managers, but blinded to researchers. Setting Patients were recruited at a Danish surgical department where the case managers were situated. Participants Colorectal cancer patients who were to undergo further investigation or treatment. Exclusion criteria were participation in another study, poor Danish language skills or apparent cognitive impairment. 140 participants were randomised to each group. Recruitment period was 11 March 2009 to 29 December 2010. Interventions Control group patients had usual care. Intervention group patients had usual care supplemented by hospital-based CM started at first visit to the out-patient clinic (before treatment start) and ended 4?weeks after completed cancer treatment. CM was conducted by nurse case managers who undertook care pathway supervision, information dissemination to health professionals and outreaching patient support. Outcome measures Patient-reported global quality of life measured with the EORTC QLQ-C30 and eight ad hoc, piloted patient evaluation items assessed at eight, 30 and 52?weeks after randomisation. Results The two groups were comparable as to questionnaire response rates and completed scales/items. There were no statistically significant group differences on any of the health-related quality of life subscales at eight, 30 or 52?weeks. In patient evaluations, all point estimates favoured CM at week 8 and 30; at week 52, 6 of 7 estimates favoured CM. Conclusions We found no evidence that CM influenced colorectal cancer patients’ health-related quality of life. Patients allocated to CM evaluated their care more positively than patients receiving usual care. Trial registration Clinicaltrials.gov identifier: NCT00845247.
机译:目的从患者报告的结局角度分析基于医院的病例管理(CM)的有效性。设计将参与者1?:?1分配给CM干预组或对照组的随机对照试验。分配状态对参与者和案例管理者很明显,但对研究人员却视而不见。背景患者是在丹麦外科手术室招募的,该室是病例管理人员所在的地方。参加者接受进一步检查或治疗的结直肠癌患者。排除标准是参加另一项研究,丹麦语能力差或明显的认知障碍。每组140名参与者被随机分配。招募期间为2009年3月11日至2010年12月29日。干预对照组患者接受常规护理。干预组患者在接受常规CM辅助治疗的同时以医院为基础的CM开始于首次就诊(在治疗开始之前),并在完成癌症治疗后4周结束。 CM由护理案例经理负责,他们进行了护理路径监督,向卫生专业人员的信息传播以及广泛的患者支持。成果衡量指标用EORTC QLQ-C30和随机分配的8、30和52周评估的8个临时的先导患者评估项目对患者报告的全球生活质量进行评估。结果两组在问卷答复率和完成的量表/项目方面具有可比性。在8周,30周或52周时,任何与健康相关的生活质量量表均没有统计学上显着的群体差异。在患者评估中,所有点估计值都倾向于在第8周和第30周使用CM;在第52周,有7个评估中有6个倾向于CM。结论我们没有发现任何证据表明CM影响大肠癌患者健康相关的生活质量。分配给CM的患者比接受常规护理的患者对其护理的评价更为积极。试用注册Clinicaltrials.gov标识符:NCT00845247。

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