Telemedicine for management of inflammatory bowel disease (myIBDcoach): a pragmatic, multicentre, randomised controlled trial
Telemedicine for management of inflammatory bowel disease (myIBDcoach): a pragmatic, multicentre, randomised controlled trial
复制标题
DOI：
10.1016/s0140-6736(17)31327-2
复制
发表时间：
2017-09-02
期刊：
影响因子：
168.9
通讯作者：
Pierik, Marie J.
中科院分区：
文献类型：
--
作者：
de Jong, Marin J.;van der Meulen-de Jong, Andrea E.;Pierik, Marie J.
背景炎症性肠病的严密和个性化控制在传统环境下是具有挑战性的，因为疾病的复杂性、门诊的高压力和发病率的上升。我们比较了自我管理和远程医疗系统的效果，远程医疗系统是为所有亚型的炎症性肠病开发的，在卫生保健利用率和患者报告的护理质量方面与标准护理相比。方法我们在荷兰的两家学术医院和两家非学术医院进行了这项务实的随机试验。18-75岁患有炎症性肠病的门诊患者，没有回肠或回肠直肠吻合术，有互联网接入和精通荷兰语，他们被随机分配(1：1)通过远程医疗系统(MyIBDcoach)进行护理，该系统监测和记录疾病活动或标准护理，并随访12个月。使用计算机生成的序列进行随机化，并使用最小化方法。参与者、医疗保健提供者和评估结果衡量标准的工作人员没有被掩饰到治疗分配中。主要结果是门诊就诊次数和患者报告的护理质量(通过视觉模拟评分0-10进行评估)。安全终点是闪光、皮质类固醇疗程、住院、急诊和手术的数量。通过意向治疗进行分析。这项试验已在临床试验中注册。在2014年9月9日至2015年5月18日期间，909名患者被随机分配到远程医疗(n=465)或标准护理(n=444)。在12个月时，远程医疗组的胃肠病医生或护士的平均门诊就诊次数(1.55[SD1.5])显著低于标准护理组(2.34[1.64]；差异-0.79[95%CI-0.98to-0.59]；p<；0.0001)，以及平均住院次数(0.05vs0.10vs0.43；差异-0.05[-0.10to0.00]；p=0.046)。在12个月时，两组患者报告的平均护理质量得分都很高(远程医疗组为8.16vs8.27[1.28]；差异为0.10[-0.13vs0.32]；p=0.411)。两组患者的平均闪光、皮质类固醇疗程、急诊和手术次数没有差异。与标准护理相比，解释远程医疗是安全的，并且减少了门诊就诊和住院次数。这种自我管理工具可能有助于将炎症性肠病的护理重新组织为个性化和基于价值的卫生保健。
Background Tight and personalised control of inflammatory bowel disease in a traditional setting is challenging because of the disease complexity, high pressure on outpatient clinics, and rising incidence. We compared the effects of self-management with a telemedicine system, which was developed for all subtypes of inflammatory bowel disease, on health-care utilisation and patient-reported quality of care versus standard care.Methods We did this pragmatic, randomised trial in two academic and two non-academic hospitals in the Netherlands. Outpatients aged 18-75 years with inflammatory bowel disease and without an ileoanal or ileorectal pouch anastomosis, who had internet access and Dutch proficiency, were randomly assigned (1: 1) to care via a telemedicine system (myIBDcoach) that monitors and registers disease activity or standard care and followed up for 12 months. Randomisation was done with a computer-generated sequence and used the minimisation method. Participants, health-care providers, and staff who assessed outcome measures were not masked to treatment allocation. Primary outcomes were the number of outpatient visits and patient-reported quality of care (assessed by visual analogue scale score 0-10). Safety endpoints were the numbers of flares, corticosteroid courses, hospital admissions, emergency visits, and surgeries. Analyses were by intention to treat. This trial is registered with ClinicalTrials. gov, number NCT02173002.Findings Between Sept 9, 2014, and May 18, 2015, 909 patients were randomly assigned to telemedicine (n=465) or standard care (n=444). At 12 months, the mean number of outpatient visits to the gastroenterologist or nurse was significantly lower in the telemedicine group (1.55 [SD1.50]) than in the standard care group (2.34 [1.64]; difference -0.79 [95%CI -0.98 to -0.59]; p < 0.0001), as was the mean number of hospital admissions (0.05 [0.28] vs 0.10 [0.43]; difference -0.05 [-0.10 to 0.00]; p=0.046). At 12 months, both groups reported high mean patient-reported quality of care scores (8.16 [1.37] in the telemedicine group vs 8.27 [1.28] in the standard care group; difference 0.10 [-0.13 to 0.32]; p=0.411). The mean numbers of flares, corticosteroid courses, emergency visits, and surgeries did not differ between groups.Interpretation Telemedicine was safe and reduced outpatient visits and hospital admissions compared with standard care. This self-management tool might be useful for reorganising care of inflammatory bowel disease towards personalised and value-based health care.