Lee Jennifer M, Woon Rex, Ramsum Mandy, Halperin Daniel S, Jain Roshini
EvergreenHealth Pain Care, Kirkland, WA, United States.
Boston Scientific Neuromodulation, Valencia, CA, United States.
JMIR Hum Factors. 2022 Mar 23;9(1):e35134. doi: 10.2196/35134.
Patient outcomes and experience during a Spinal Cord Stimulation (SCS) screening trial can have a significant effect on whether to proceed with long-term, permanent implantation of an SCS device for the treatment of chronic pain. Enhancing the ability to track and assess patients during this initial trial evaluation offers the potential for improved understanding regarding the suitability of permanent device implantation as well as identification of the SCS-based neurostimulative modalities and parameters that may provide substantial analgesia in a patient-specific manner.
In this report, we aimed to describe a preliminary, real-world assessment of a new, real time tracking, smart, device-based digital app used by patients with chronic pain undergoing trial screening for SCS therapy.
This is a real-world, retrospective evaluation of 13,331 patients diagnosed with chronic pain who used the new "mySCS" mobile app during an SCS screening trial. The app design is health insurance portability and accountability act (HIPAA)-compliant and compatible with most commercially available smartphones (eg, Apple, iPhone, and Android). The app enables tracking of user-inputted health-related responses (ie, pain relief, activity level, and sleep quality) in addition to personal trial goals and a summary of overall experience during the SCS trial. A deidentified, aggregate analysis of user engagement, user-submitted responses, and overall trial success was conducted.
When provided the opportunity, the percentage of users who engaged with the tracking app for ≥50% of the time during their trial was found to be 64.43% (n=8589). Among the 13,331 patients who used the app, 58.24% (n=7764) entered a trial goal. Most patients underwent SCS screening with a trial duration of at least 7 days (n=7739, 58.05%). Of those patients who undertook a 7-day SCS trial, 62.30% (n=3456) engaged the app for 4 days or more. In addition, among all who submitted descriptive responses using the app, health-related improvements were reported by 77.84% (n=10,377) of patients who reached day 3 of the screening phase assessment and by 83.04% (n=11,070) of those who reached trial completion. A trial success rate of 91% was determined for those who used the app (versus 85% success rate for nonusers).
Data from this initial, real-world examination of a mobile, digital-health-based tracking app ("mySCS"), as used during the SCS screening phase, demonstrate that substantial patient engagement can be achieved while also providing for the acquisition of more real time patient-outcome measures that may help facilitate improved SCS trial success.
脊髓刺激（SCS）筛查试验期间的患者预后和体验对是否继续长期、永久植入SCS设备以治疗慢性疼痛具有重大影响。在这一初始试验评估过程中增强跟踪和评估患者的能力，有可能加深对永久设备植入适用性的理解，并确定可能以患者特异性方式提供显著镇痛效果的基于SCS的神经刺激模式和参数。
在本报告中，我们旨在描述对一款新的、基于智能设备的数字应用程序进行的初步真实世界评估，该应用程序用于接受SCS治疗试验筛查的慢性疼痛患者进行实时跟踪。
这是一项对13331例被诊断为慢性疼痛且在SCS筛查试验期间使用新的“mySCS”移动应用程序的患者进行的真实世界回顾性评估。该应用程序的设计符合《健康保险流通与责任法案》（HIPAA），并与大多数商用智能手机（如苹果、iPhone和安卓）兼容。除了个人试验目标和SCS试验期间的总体体验总结外，该应用程序还能跟踪用户输入的与健康相关的反应（即疼痛缓解、活动水平和睡眠质量）。对用户参与度、用户提交的反应和总体试验成功率进行了去识别化的汇总分析。
当有机会使用该应用程序时，发现在试验期间使用跟踪应用程序时间≥50%的用户比例为64.43%（n = 8589）。在使用该应用程序的13331例患者中，58.24%（n = 7764）设定了试验目标。大多数患者进行SCS筛查的试验持续时间至少为7天（n = 7739，58.05%）。在进行7天SCS试验的患者中，62.30%（n = 3456）使用该应用程序4天或更长时间。此外，在所有使用该应用程序提交描述性反应的患者中，进入筛查阶段评估第3天的患者中有77.84%（n = 10377）报告了与健康相关的改善，完成试验的患者中有83.04%（n = 11070）报告了改善。使用该应用程序的患者试验成功率为91%（未使用该应用程序的患者成功率为85%）。
在SCS筛查阶段使用的基于移动数字健康的跟踪应用程序（“mySCS”）的这一初步真实世界研究数据表明，在实现大量患者参与的同时，还能获取更多实时患者预后指标，这可能有助于提高SCS试验的成功率。
