一种用于改善腰痛自我管理的数字决策支持系统（selfBACK）：一项为期6周随访的试点研究。
A digital decision support system (selfBACK) for improved self-management of low back pain: a pilot study with 6-week follow-up.
作者信息
Sandal Louise Fleng, Øverås Cecilie K, Nordstoga Anne Lovise, Wood Karen, Bach Kerstin, Hartvigsen Jan, Søgaard Karen, Mork Paul Jarle
机构信息
Department of Sport Science and Clinical Biomechanics, University of Southern Denmark (UoSD), Odense, Denmark.
Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.
出版信息
Pilot Feasibility Stud. 2020 May 23;6:72. doi: 10.1186/s40814-020-00604-2. eCollection 2020.
BACKGROUND
Very few of the publicly available apps directed towards self-management of low back pain (LBP) have been rigorously tested and their theoretical underpinnings seldom described. The selfBACK app was developed in collaboration with end-users and clinicians and its content is supported by best evidence on self-management of LBP. The objectives of this pilot study were to investigate the basis for recruitment and screening procedures for the subsequent randomized controlled trial (RCT), to test the inclusion process in relation to questionnaires and app installation, and finally to investigate the change in primary outcome over time.
METHODS
This single-armed pilot study enrolled 51 participants who had sought help for LBP of any duration from primary care (physiotherapy, chiropractic, or general practice) within the past 8 weeks. Participants were screened for eligibility using the PROMIS-Physical-Function-4a questionnaire. Participants were asked to use the selfBACK app for 6 weeks. The app provided weekly tailored self-management plans targeting physical activity, strength and flexibility exercises, and education. The construction of the self-management plans was achieved using case-based reasoning (CBR) methodology to capture and reuse information from previous successful cases. Participants completed the primary outcome pain-related disability (Roland-Morris Disability Questionnaire [RMDQ]) at baseline and 6-week follow-up along with a range of secondary outcomes. Metrics of app use were collected throughout the intervention period.
RESULTS
Follow-up data at 6 weeks was obtained for 43 participants. The recruitment procedures were feasible, and the number needed to screen was acceptable (i.e., 1.6:1). The screening questionnaire was altered during the pilot study. The inclusion process, answering questionnaires and app installation, were feasible. The primary outcome (RMDQ) improved from 8.6 (SD 5.1) at baseline to 5.9 (SD 4.0) at 6-week follow-up (change score 1.8, 95% CI 0.7 to 2.9). Participants spent on average 134 min (range 0-889 min) using the app during the 6-week period.
CONCLUSION
The recruitment, screening, and inclusion procedures were feasible for the subsequent RCT with a small adjustment. The improvement on the RMDQ from baseline to follow-up was small. Time pattern of app usage varied considerably between the participants.
TRIAL REGISTRATION
NCT03697759. Registered on August 10, 2018. https://clinicaltrials.gov/ct2/show/NCT03697759.
背景
很少有面向腰痛（LBP）自我管理的公开可用应用程序经过严格测试，其理论基础也很少被描述。selfBACK应用程序是与终端用户和临床医生合作开发的，其内容得到了LBP自我管理的最佳证据支持。这项试点研究的目的是调查后续随机对照试验（RCT）的招募和筛选程序的依据，测试与问卷和应用程序安装相关的纳入过程，最后调查主要结局随时间的变化。
方法
这项单臂试点研究招募了51名参与者，他们在过去8周内曾因任何时长的腰痛向初级保健机构（物理治疗、整脊或全科医疗）寻求帮助。使用PROMIS-Physical-Function-4a问卷对参与者进行资格筛选。要求参与者使用selfBACK应用程序6周。该应用程序每周提供针对身体活动、力量和灵活性锻炼以及教育的量身定制的自我管理计划。自我管理计划的构建采用基于案例的推理（CBR）方法，以获取和重用先前成功案例的信息。参与者在基线和6周随访时完成主要结局疼痛相关残疾（罗兰-莫里斯残疾问卷[RMDQ]）以及一系列次要结局。在整个干预期收集应用程序使用指标。
结果
43名参与者获得了6周时的随访数据。招募程序可行，筛选所需人数可接受（即1.6:1）。在试点研究期间对筛选问卷进行了修改。纳入过程、回答问卷和应用程序安装都是可行的。主要结局（RMDQ）从基线时的8.6（标准差5.1）改善到6周随访时的5.9（标准差4.0）（变化分数1.8，95%置信区间0.7至2.9）。参与者在6周期间平均花费134分钟（范围0 - 889分钟）使用该应用程序。
结论
经过小的调整后，招募、筛选和纳入程序对于后续的RCT是可行的。从基线到随访，RMDQ的改善较小。参与者之间应用程序使用的时间模式差异很大。
试验注册
NCT03697759。于2018年8月10日注册。https://clinicaltrials.gov/ct2/show/NCT03697759。
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