UNASSIGNED:结核病数字依从性技术的成功取决于患者对该技术的满意度和可用性。本研究旨在评估结核病患者数字药物事件提醒和监测(MERM)设备的治疗满意度和可用性,以解决SELFTB试验的预设次要终点。
未经评估:在此多中心中,随机对照试验,成人(≥18岁)与新的或以前治疗,细菌学证实,有资格开始抗结核治疗的药物敏感性肺结核从埃塞俄比亚的10个医疗机构招募.使用计算机生成的随机数序列,参与者以1:1的比例被随机分配,接受15天的结核病药物供应,并配发evriMED500®MERM装置,自我给药,每15天返回一次或标准的当面DOT.在整个标准的两个月强化治疗阶段都随访两组。治疗基于WHO推荐的为期两个月的固定剂量组合的一线抗结核药物作为单日剂量(2RHZE)。使用第4版药物治疗满意度问卷(TSQM1.4©)来衡量和比较两组之间的治疗满意度。自适应系统可用性量表(SUS)用于评估设备的可用性,强调易用性,挑战,好处,动机,人气,和推荐。结果与依从性和临床终点相关,包括痰涂片转换和IsoScreen尿液异烟肼测试结果。该试验已在ClinicalTrials.gov注册,NCT04216420。
UNASSIGNED:在2020年6月2日至2021年6月15日之间,对337名患者进行了资格筛选。其中109名参与者登记并完成了满意度[控制(n=57)和干预(n=52)分组]和可用性[干预分组(n=52)]问卷。TSQM1.4©几何平均值分数为:有效性73.25[几何标准偏差(GSD)1.28],副作用100,便利性63.31(GSD1.45),和全球满意度77.29(GSD1.25)。干预组TSQM评分明显高于对照组:有效性[85.78vs63.43,95%CI1.35(1.26-1.45),p<0.001],便利性[85.41vs48.18,95%CI1.77(1.63-1.93),p<0.001],和全球满意度[90.19vs67.11,95%CI1.34(1.26-1.43),p<0.001]。总体满意度和药物依从性之间存在显著关联(p=0.017)。SUS平均得分为97.45%,接近100%的最佳可想象SUS值。对于90.4%的MERM用户,推荐可能性(LTR)值≥9,量表范围为0-10,产生更高的净启动子。可用性与药物依从性之间没有显着关联(p=0.691)。
UNASSIGNED:我们的研究结果表明,干预措施与对照组以及有效性领域的治疗满意度得分均较高。方便,全球满意度。MERM设备具有出色的可用性,并且可能推广该设备的用户数量明显更高。高结核病负担国家可以通过持续评估和扩大数字健康创新来改变以患者为中心的护理。
UNASSIGNED:美国国立卫生研究院(NIH)福格蒂国际中心和国家过敏和传染病研究所(D43TW009127)和埃默里艾滋病研究中心(P30AI050409)。
UNASSIGNED: The success of a tuberculosis digital adherence technology relies on patients\' satisfaction with and the usability of the technology. This study aimed to evaluate treatment satisfaction and usability of a digital medication event reminder and monitor (MERM) device for patients with tuberculosis to address the prespecified secondary endpoint of the SELFTB trial.
UNASSIGNED: In this multicenter, randomised controlled trial, adults (≥18 years) with new or previously treated, bacteriologically-confirmed, drug-sensitive pulmonary tuberculosis who were eligible to start anti-tuberculosis therapy were recruited from 10 healthcare facilities in Ethiopia. With a computer-generated random number sequence, participants were randomly assigned 1:1 to receive a 15-day tuberculosis medication supply dispensed with an evriMED500® MERM device to self-administer and return every 15 days or the standard in-person DOT. Both arms were followed throughout the standard two-month intensive treatment phase. Treatment was based on the WHO-recommended two-month fixed-dose-combination of first-line anti-tuberculosis drug delivered as a single daily dose (2RHZE). Treatment Satisfaction Questionnaire for Medication version 4 (TSQM 1.4©) was used to measure and compare treatment satisfaction between arms. Adapted System Usability Scale (SUS) was used to assess the usability of the device, with emphasis on ease of use, challenges, benefits, motivation, popularity, and recommendation. The findings were correlated with adherence and clinical endpoints including sputum smear conversion and IsoScreen urine isoniazid test results. This trial is registered with ClinicalTrials.gov, NCT04216420.
UNASSIGNED: Between June 2, 2020, and June 15, 2021, 337 patients were screened for eligibility, of whom 109 participants enrolled and completed the satisfaction [control (n = 57) and intervention (n = 52) arms] and usability [intervention arm (n = 52)] questionnaires. TSQM 1.4© geometric mean scores were: Effectiveness 73.25 [geometric standard deviation (GSD) 1.28], Side Effects 100, Convenience 63.31 (GSD 1.45), and Global Satisfaction 77.29 (GSD 1.25). TSQM score was significantly higher in the intervention vs the control: Effectiveness [85.78 vs 63.43, 95% CI 1.35 (1.26-1.45), p < 0.001], Convenience [85.41 vs 48.18, 95% CI 1.77 (1.63-1.93), p < 0.001], and Global Satisfaction [90.19 vs 67.11, 95% CI 1.34 (1.26-1.43), p < 0.001]. There were significant associations between Global Satisfaction and medication adherence (p = 0.017). Average SUS score was 97.45%, which was close to the best imaginable SUS value of 100%. Likelihood to Recommend (LTR) value was ≥9, on a scale of 0-10, for 90.4% of MERM users, yielding higher net promoters. There was no significant association between usability and medication adherence (p = 0.691).
UNASSIGNED: Our findings suggested that treatment satisfaction scores were superior in the intervention vs control arms and across the domains of Effectiveness, Convenience, and Global Satisfaction. There was excellent usability of the MERM device and a significantly higher number of users likely to promote the device. High tuberculosis burden countries may transform patient-centered care through ongoing evaluation and scale-up of digital health innovations.
UNASSIGNED: U.S. National Institute of Health (NIH) Fogarty International Center and National Institute of Allergy and Infectious Diseases (D43 TW009127) and the Emory Center for AIDS Research (P30 AI050409).