Bourne Simon, DeVos Ruth, North Malcolm, Chauhan Anoop, Green Ben, Brown Thomas, Cornelius Victoria, Wilkinson Tom
Portsmouth Hospitals NHS Trust, Portsmouth, UK.
myMHealth Ltd Bournemouth, UK.
BMJ Open. 2017 Jul 17;7(7):e014580. doi: 10.1136/bmjopen-2016-014580.
To obtain evidence whether the online pulmonary rehabilitation(PR) programme 'my-PR' is non-inferior to a conventional face-to-face PR in improving physical performance and symptom scores in patients with COPD.
A two-arm parallel single-blind, randomised controlled trial.
The online arm carried out pulmonary rehabilitation in their own homes and the face to face arm in a local rehabilitation facility.
90 patients with a diagnosis of chronic obstructive pulmonary disease (COPD), modified Medical Research Council score of 2 or greater referred for pulmonary rehabilitation (PR), randomised in a 2:1 ratio to online (n=64) or face-to-face PR (n=26). Participants unable to use an internet-enabled device at home were excluded.
Coprimary outcomes were 6 min walk distance test and the COPD assessment test (CAT) score at completion of the programme.
A 6-week PR programme organised either as group sessions in a local rehabilitation facility, or online PR via log in and access to 'myPR'.
The adjusted mean difference for the 6 min walk test (6MWT) between groups for the intention-to-treat (ITT) population was 23.8 m with the lower 95% CI well above the non-inferiority threshold of -40.5 m at -4.5 m with an upper 95% CI of +52.2 m. This result was consistent in the per-protocol (PP) population with a mean adjusted difference of 15 m (-13.7 to 43.8). The CAT score difference in the ITT was -1.0 in favour of the online intervention with the upper 95% CI well below the non-inferiority threshold of 1.8 at 0.86 and the lower 95% CI of -2.9. The PP analysis was consistent with the ITT.
PR is an evidenced-based and guideline-mandated intervention for patients with COPD with functional limitation. A 6-week programme of online-supported PR was non-inferior to a conventional model delivered in face-to-face sessions in terms of effects on 6MWT distance, and symptom scores and was safe and well tolerated.
获取证据,以证明在线肺康复(PR)项目“我的PR”在改善慢性阻塞性肺疾病(COPD)患者的身体机能和症状评分方面是否不劣于传统的面对面PR。
双臂平行单盲随机对照试验。
在线组在自己家中进行肺康复,面对面组在当地康复机构进行。
90例诊断为慢性阻塞性肺疾病(COPD)、改良医学研究委员会评分2分或更高且被转诊接受肺康复(PR)的患者,按2:1的比例随机分为在线组(n = 64)或面对面PR组(n = 26)。排除在家中无法使用联网设备的参与者。
共同主要结局指标为项目结束时的6分钟步行距离测试和慢性阻塞性肺疾病评估测试(CAT)评分。
一个为期6周的PR项目,可在当地康复机构以小组形式进行,或通过登录并访问“我的PR”进行在线PR。
意向性分析(ITT)人群中,两组间6分钟步行测试(6MWT)的调整后平均差异为23.8米,95%置信区间下限远高于非劣效性阈值-40.5米,为-4.5米,95%置信区间上限为+52.2米。在符合方案(PP)人群中结果一致,平均调整差异为15米(-13.7至43.8)。ITT中CAT评分差异为-1.0,有利于在线干预,95%置信区间上限远低于非劣效性阈值1.8,为0.86,95%置信区间下限为-2.9。PP分析与ITT一致。
PR是针对有功能限制的COPD患者的一种基于证据且符合指南要求的干预措施。为期6周的在线支持PR项目在对6MWT距离和症状评分的影响方面不劣于传统的面对面模式,且安全且耐受性良好。