N-of-1 Trials Using mHealth in Chronic Pain

使用移动健康治疗慢性疼痛的 N-of-1 试验

基本信息

批准号：
8419238
负责人：
RICHARD L KRAVITZ
金额：
$ 64.73万
依托单位：
UNIVERSITY OF CALIFORNIA AT DAVIS
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-09-26 至 2017-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8419238
关键词：
Accident and Emergency department Accounting Acetaminophen Address Adherence Adjuvant Adult Affect American Analgesics Anti-Inflammatory Agents Anti-inflammatory Architecture Back Bayesian Method Car Phone Caring Chronic Clinical Communities Computer software Cross-Over Studies Decision Making Devices Disadvantaged Dose Drug Prescriptions Enrollment Goals Health Health Care Costs Health Personnel Health system Healthcare Healthcare Systems Heterogeneity Hour Individual Internet Lead Musculoskeletal Pain Office Visits Opioid Opioid Analgesics Opioid Rotation Outcome Pain Pain intensity Pain interference Pain management Participant Patients Perception Pharmaceutical Preparations Placebo Effect Population Randomized Randomized Controlled Trials Regimen Research Research Infrastructure Research Personnel Resort Running Staging Techniques Technology Telephone Testing Therapeutic Time Titrations Toxic effect Traction Uncertainty Variant Visit Work base chronic pain compare effectiveness cost design evidence base experience follow-up hazard health related quality of life improved patient oriented primary outcome research study response satisfaction secondary outcome success tool treatment as usual treatment effect trial comparing uptake usability

项目摘要

DESCRIPTION (provided by applicant): Chronic musculoskeletal pain (MSP) is an enormous problem, affecting more than 100 million Americans (many from disadvantaged groups) and costing upwards of $160 billion. Current pharmaco-therapeutic strategies convey a mix of benefits and hazards. In usual practice, clinicians resort to opioid analgesics, often reluctantly, when other drugs are seemingly ineffective or contraindicated. Finding an effective regimen is frequently a matter of trial and error. This approach may work but is subject to bias. A treatment that appears effective (or ineffective) over the short term may only seem so because of random fluctuation in the patient's underlying condition. To discover the true effect and thus optimize individual treatment, a more scientific approach is needed. N-of-1 trials are randomized controlled crossover trials conducted in a single patient. By crossing a patient back and forth between two treatments several times, clinicians can identify the more effective approach for that individual patient with greater precision than can be achieved in ordinary practice. By generating individual treatment effects, n-of-1 trials pose a challenge to "evidence-based trial and error," the reigning clinical paradigm for treatment of chronic, symptomatic conditions. N-of-1 trials are an intuitively appealing and demonstrably successful approach but have failed to gain much traction, largely due to lack of infrastructure. Mobile devices can change that. This proposal weds mobile technology with personalized health care to address the clinical problem of determining what works for an individual patient. Our goal is to provide tools for identifying individual treatment effects to patients and their clinicians, and to evaluate this approach in terms of patient outcomes and costs to the health care system. The specific aims of this application are: 1) to develop and refine a mobile web application ("the Trialist") to conduct n-of 1 trials among vulnerable patients with chronic musculoskeletal pain; and 2) to assess in a randomized controlled trial (RCT) the effects of participating in a mobile n-of-1 trial (versus usul care) on clinical outcomes; participatory decision making; satisfaction; adherence; and health care costs. Building on software architecture already developed by Open mHealth.org, the research team will develop, refine, and test the Trialist software over the first 18 months of the project. Then 296 patients with chronic musculoskeletal pain will be randomized to using Trialist to conduct an n-of-1 trial or to usual care. The main hypothesis is that patients assigned to the Trialist will experience better long term outcomes (particularly pain interference at 6 months) compared with those assigned to usual care. Achieving these aims will set the stage for broader uptake of mHealth n-of-1 trials in chronic pain and facilitate use of mHealth n-of-1 trials in designing chronic health care management. ! PUBLIC HEALTH RELEVANCE: Chronic musculoskeletal pain is an enormous problem, and treatments are often prescribed in a "trial and error" fashion. This project seeks to develop a mobile phone application ("app") that allows patients and their health care providers to run rigorous, personalized experiments ("n-of-1 trials") comparing two different pain treatments. Once the app is developed, the investigators will enroll 296 patients in a randomized study that looks at long term pain outcomes among patients assigned to undergo an n-of-1 trial using the app versus usual care. The project enlists mobile technology to help patients engage actively and collaboratively with their clinicians to identify the pain treatment that works best for them.

描述（由申请人提供）：慢性肌肉骨骼疼痛 (MSP) 是一个巨大的问题，影响着超过 1 亿美国人（其中许多来自弱势群体），造成的损失高达 1,600 亿美元。当前的药物治疗策略既有好处也有危害。在通常的实践中，临床医生往往不情愿地诉诸阿片类镇痛药，当其他药物似乎无效或有禁忌时。寻找有效的治疗方案通常需要反复试验。这种方法可能有效，但会存在偏见。短期内看似有效（或无效）的治疗可能只是因为患者基础病情的随机波动而显得如此。为了发现真正的效果并从而优化个体治疗，需要更科学的方法。 N-of-1 试验是在单个患者中进行的随机对照交叉试验。通过在两种治疗之间来回切换患者几次，临床医生可以比普通实践更精确地为该患者找出更有效的方法。通过产生个体治疗效果，n-of-1 试验对“基于证据的试验和错误”提出了挑战，“基于证据的试验和错误”是治疗慢性症状性疾病的主导临床范式。 N-of-1 试验是一种直观上有吸引力且明显成功的方法，但未能获得太多关注，这主要是由于缺乏基础设施。移动设备可以改变这一点。该提案将移动技术与个性化医疗保健相结合，以解决确定哪种方法对个体患者有效的临床问题。我们的目标是为患者及其临床医生提供识别个体治疗效果的工具，并根据患者的治疗结果和医疗保健系统的成本来评估这种方法。该应用程序的具体目标是：1) 开发和完善移动 Web 应用程序（“Trialist”）以进行 n-of 1 在患有慢性肌肉骨骼疼痛的弱势患者中进行的试验； 2) 在随机对照试验 (RCT) 中评估参与移动 n-of-1 试验（与常规护理相比）对临床结果的影响；参与式决策；满意;坚持；和医疗保健费用。研究团队将在 Open mHealth.org 已开发的软件架构的基础上，在项目的前 18 个月内开发、完善和测试 Trialist 软件。然后，296 名患有慢性肌肉骨骼疼痛的患者将被随机分配到使用 Trialist 进行 n-of-1 试验或接受常规护理。主要假设是，与分配到常规护理的患者相比，分配到试验组的患者将经历更好的长期结果（特别是 6 个月时的疼痛干扰）。实现这些目标将为更广泛地采用 mHealth n-of-1 试验治疗慢性疼痛奠定基础，并促进使用 mHealth n-of-1 试验来设计慢性医疗保健管理。！公共健康相关性：慢性肌肉骨骼疼痛是一个巨大的问题，治疗方法通常是以“反复试验”的方式进行的。该项目旨在开发一款手机应用程序（“应用程序”），允许患者及其医疗保健提供者进行严格的个性化实验（“n-of-1 试验”），比较两种不同的疼痛治疗方法。该应用程序开发完成后，研究人员将招募 296 名患者参加一项随机研究，该研究将观察被分配使用该应用程序与常规护理进行 n-of-1 试验的患者的长期疼痛结果。该项目利用移动技术帮助患者积极与临床医生合作，以确定最适合他们的疼痛治疗方法。