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COMET: a multicomponent home-based disease-management programme versus routine care in severe COPD
European Respiratory Journal ( IF 24.3 ) Pub Date : 2018-01-01 , DOI: 10.1183/13993003.01612-2017
Romain Kessler , Pere Casan-Clara , Dieter Koehler , Silvia Tognella , Jose Luis Viejo , Roberto W. Dal Negro , Salvador Díaz-Lobato , Karina Reissig , José Miguel Rodríguez González-Moro , Gilles Devouassoux , Jean-Michel Chavaillon , Pierre Botrus , Jean-Michel Arnal , Julio Ancochea , Anne Bergeron-Lafaurie , Carlos De Abajo , Winfried J. Randerath , Andreas Bastian , Christian G. Cornelissen , Georg Nilius , Joëlle B. Texereau , Jean Bourbeau

The COPD Patient Management European Trial (COMET) investigated the efficacy and safety of a home-based COPD disease management intervention for severe COPD patients. The study was an international open-design clinical trial in COPD patients (forced expiratory volume in 1 s <50% of predicted value) randomised 1:1 to the disease management intervention or to the usual management practices at the study centre. The disease management intervention included a self-management programme, home telemonitoring, care coordination and medical management. The primary end-point was the number of unplanned all-cause hospitalisation days in the intention-to-treat (ITT) population. Secondary end-points included acute care hospitalisation days, BODE (body mass index, airflow obstruction, dyspnoea and exercise) index and exacerbations. Safety end-points included adverse events and deaths. For the 157 (disease management) and 162 (usual management) patients eligible for ITT analyses, all-cause hospitalisation days per year (mean±sd) were 17.4±35.4 and 22.6±41.8, respectively (mean difference −5.3, 95% CI −13.7 to −3.1; p=0.16). The disease management group had fewer per-protocol acute care hospitalisation days per year (p=0.047), a lower BODE index (p=0.01) and a lower mortality rate (1.9% versus 14.2%; p<0.001), with no difference in exacerbation frequency. Patient profiles and hospitalisation practices varied substantially across countries. The COMET disease management intervention did not significantly reduce unplanned all-cause hospitalisation days, but reduced acute care hospitalisation days and mortality in severe COPD patients. Lower all-cause mortality in multicomponent home-based disease management programme vs routine care in severe COPD http://ow.ly/sykh30gS5XO

中文翻译:

COMET:多组分家庭疾病管理计划与严重 COPD 的常规护理

COPD 患者管理欧洲试验 (COMET) 调查了以家庭为基础的 COPD 疾病管理干预对严重 COPD 患者的有效性和安全性。该研究是一项国际开放设计临床试验,针对 COPD 患者(1 秒内用力呼气量<预测值的 50%)以 1:1 的比例随机分配至疾病管理干预或研究中心的常规管理实践。疾病管理干预包括自我管理计划、家庭远程监控、护理协调和医疗管理。主要终点是意向治疗 (ITT) 人群中计划外全因住院天数。次要终点包括急性护理住院天数、BODE(体重指数、气流阻塞、呼吸困难和运动)指数和恶化。安全终点包括不良事件和死亡。对于符合 ITT 分析条件的 157 名(疾病管理)和 162 名(常规管理)患者,每年全因住院天数(平均值±sd)分别为 17.4±35.4 和 22.6±41.8(平均差 -5.3,95% CI -13.7 至 -3.1;p=0.16)。疾病管理组每年符合方案的急性护理住院天数较少 (p=0.047)、BODE 指数较低 (p=0.01) 和死亡率较低(1.9% 对 14.2%;p<0.001),没有差异在恶化频率。不同国家的患者概况和住院实践差异很大。COMET 疾病管理干预并未显着减少计划外全因住院天数,但减少了重症 COPD 患者的急诊住院天数和死亡率。
更新日期:2018-01-01
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