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全喉切除术后患者的引导式自助头颈部锻炼计划的成本-效用和成本-效果:一项多中心随机对照试验的结果。

Cost-utility and cost-effectiveness of a guided self-help head and neck exercise program for patients treated with total laryngectomy: Results of a multi-center randomized controlled trial.

机构信息

Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), Amsterdam UMC, PO Box 7057, 1007 MB Amsterdam, the Netherlands.

Department of Epidemiology and Data Science, Amsterdam UMC, PO Box 7057, 1007 MB Amsterdam, the Netherlands.

出版信息

Oral Oncol. 2021 Jun;117:105306. doi: 10.1016/j.oraloncology.2021.105306. Epub 2021 Apr 24.

Abstract

OBJECTIVES

The guided self-help exercise program called In Tune without Cords (ITwC) is effective in improving swallowing problems and communication among patients treated with a total laryngectomy (TL). This study investigated the cost-utility and cost-effectiveness of ITwC.

MATERIALS AND METHODS

Patients within 5 years after TL were included in this randomized controlled trial. Patients in the intervention group (n = 46) received access to the self-help exercise program with flexibility, range-of-motion and lymphedema exercises, and a self-care education program. Patients in the control group (n = 46) received access to the self-care education program only. Healthcare utilization (iMCQ), productivity losses (iPCQ), health status (EQ-5D-3L, EORTC QLU-C10D) and swallowing problems (SwalQol) were measured at baseline, 3- and 6-months follow-up. Hospital costs were extracted from medical files. Mean total costs and effects (quality-adjusted life-years (QALYs) or SwalQol score) were compared with regression analyses using bias-corrected accelerated bootstrapping.

RESULTS

Mean total costs were non-significantly lower (-€685) and QALYs were significantly higher (+0.06) in the intervention compared to the control group. The probability that the intervention is less costly and more effective was 73%. Sensitivity analyses with adjustment for baseline costs and EQ-5D scores showed non-significantly higher costs (+€119 to +€364) and QALYs (+0.02 to +0.03). A sensitivity analysis using the QLU-C10D to calculate QALYs showed higher costs (+€741) and lower QALYs (-0.01) and an analysis that used the SwalQol showed higher costs (+€232) and higher effects (improvement of 6 points on a 0-100 scale).

CONCLUSION

ITwC is likely to be effective, but possibly at higher expenses.

TRIAL REGISTRATION

NTR5255.

摘要

目的

名为“有调无弦”(In Tune without Cords,简称 ITwC)的指导自助锻炼方案对改善全喉切除术后(total laryngectomy,TL)患者的吞咽问题和沟通有明显效果。本研究旨在调查 ITwC 的成本效用和成本效果。

材料与方法

本研究为一项随机对照试验,纳入 TL 术后 5 年内的患者。干预组(n=46)患者可访问自助锻炼方案,包括灵活性、运动范围和淋巴水肿锻炼以及自我护理教育方案;对照组(n=46)患者仅可访问自我护理教育方案。在基线、3 个月和 6 个月随访时,测量医疗资源利用(iMCQ)、生产力损失(iPCQ)、健康状况(EQ-5D-3L、EORTC QLU-C10D)和吞咽问题(SwalQol)。从病历中提取医院费用。使用偏差校正加速 bootstrap 回归分析比较干预组和对照组的平均总费用和效果(质量调整生命年(quality-adjusted life-years,QALYs)或 SwalQol 评分)。

结果

干预组的平均总费用显著降低(-€685),QALYs 显著增加(+0.06)。干预组成本更低且效果更好的概率为 73%。调整基线成本和 EQ-5D 评分后的敏感性分析显示,干预组的成本(+€119 至+€364)和 QALYs(+0.02 至+0.03)略有增加。使用 QLU-C10D 计算 QALYs 的敏感性分析显示,成本更高(+€741),QALYs 更低(-0.01);使用 SwalQol 计算 QALYs 的敏感性分析显示,成本更高(+€232),效果更好(0-100 评分提高 6 分)。

结论

ITwC 可能有效,但费用可能更高。

临床试验注册

NTR5255。

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