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：
8551710
负责人：
RICHARD L KRAVITZ
金额：
$ 57.18万
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/8551710
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 public health relevance 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. !

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，影响了超过1亿美国人（许多来自弱势群体），成本高达1600亿美元。当前的药房治疗策略传达了各种福利和危害。在通常的实践中，临床医生通常不情愿地求助于阿片类镇痛药当其他药物似乎无效或禁忌时。寻找有效的方案通常是反复试验的问题。这种方法可能起作用，但会产生偏见。在短期内似乎有效（或无效）的一种治疗方法似乎仅仅是因为患者的潜在状况随机波动。为了发现真正的效果并因此优化了个体治疗，需要采用更科学的方法。 N-1-1试验是在单个患者中进行的随机对照跨界试验。通过多次在两次治疗之间来回跨越患者，临床医生可以确定该患者的精度比普通练习更有效的方法。通过产生个体治疗效果，N-OF-1试验对“基于证据的反复试验”构成了挑战，即统治临床范式用于治疗慢性，有症状的疾病。 N-1-1试验是一种直觉上具有吸引力且明显成功的方法，但未能获得很多吸引力，这主要是由于缺乏基础设施。移动设备可以更改。该建议将移动技术与个性化的医疗保健联系在一起，以解决确定哪些对单个患者有用的临床问题。我们的目标是提供为患者及其临床医生识别个人治疗效果的工具，并根据患者的结果和医疗保健系统的成本评估这种方法。本应用程序的具体目的是：1）开发和完善移动Web应用程序（“试验员”）以进行n 1次慢性肌肉骨骼疼痛患者的试验； 2）在一项随机对照试验（RCT）中评估参加移动N-OF-1试验（与USUL CARE）对临床结果的影响；参与性决策；满意;依从性；和医疗保健费用。在项目的前18个月内，研究团队将在已开放的MHealth.org开发的软件体系结构的基础上开发，完善和测试试用器软件。然后，有296例慢性肌肉骨骼疼痛的患者将随机分配给使用试验者进行N-1-1试验或通常的护理。主要假设是，与分配给常规护理的患者相比，分配给试验人员的患者将经历更好的长期结局（尤其是在6个月时干扰）。实现这些目标将为慢性疼痛中的MHealth N-1-1-1试验更广泛地介绍，并促进在设计慢性医疗保健管理时使用MHealth N-1-1-1试验。呢