Mobile phones and devices, with their constant presence, data connectivity, and multiple intrinsic sensors, can support around-the-clock chronic disease prevention and management that is integrated with daily life. These mobile health (mHealth) devices can produce tremendous amounts of location-rich, real-time, high-frequency data. Unfortunately, these data are often full of bias, noise, variability, and gaps. Robust tools and techniques have not yet been developed to make mHealth data more meaningful to patients and clinicians. To be most useful, health data should be sharable across multiple mHealth applications and connected to electronic health records. The lack of data sharing and dearth of tools and techniques for making sense of health data are critical bottlenecks limiting the impact of mHealth to improve health outcomes. We describe Open mHealth, a nonprofit organization that is building an open software architecture to address these data sharing and “sense-making” bottlenecks. Our architecture consists of open source software modules with well-defined interfaces using a minimal set of common metadata. An initial set of modules, called InfoVis, has been developed for data analysis and visualization. A second set of modules, our Personal Evidence Architecture, will support scientific inferences from mHealth data. These Personal Evidence Architecture modules will include standardized, validated clinical measures to support novel evaluation methods, such as n-of-1 studies. All of Open mHealth’s modules are designed to be reusable across multiple applications, disease conditions, and user populations to maximize impact and flexibility. We are also building an open community of developers and health innovators, modeled after the open approach taken in the initial growth of the Internet, to foster meaningful cross-disciplinary collaboration around new tools and techniques. An open mHealth community and architecture will catalyze increased mHealth efficiency, effectiveness, and innovation.

BackgroundChronic pain is prevalent, costly, and clinically vexatious. Clinicians typically use a trial-and-error approach to treatment selection. Repeated crossover trials in a single patient (n-of-1 trials) may provide greater therapeutic precision. N-of-1 trials are the most direct way to estimate individual treatment effects and are useful in comparing the effectiveness and toxicity of different analgesic regimens. The goal of the PREEMPT study is to test the ‘Trialist’ mobile health smartphone app, which has been developed to make n-of-1 trials easier to accomplish, and to provide patients and clinicians with tools for individualizing treatments for chronic pain.Methods/designA randomized controlled trial is being conducted to test the feasibility and effectiveness of the Trialist app. A total of 244 participants will be randomized to either the Trialist app intervention group (122 patients) or a usual care control group (122 patients). Patients assigned to the Trialist app will work with their clinicians to set up an n-of-1 trial comparing two pain regimens, selected from a menu of flexible options. The Trialist app provides treatment reminders and collects data entered daily by the patient on pain levels and treatment side effects. Upon completion of the n-of-1 trial, patients review results with their clinicians and develop a long-term treatment plan. The primary study outcome (comparing Trialist to usual care patients) is pain-related interference with daily functioning at 26 weeks.DiscussionTrialist will allow patients and clinicians to conduct personalized n-of-1 trials. In prior studies, n-of-1 trials have been shown to encourage greater patient involvement with care, which has in turn been associated with better health outcomes. mHealth technology implemented using smartphones may offer an efficient means of facilitating n-of-1 trials so that more patients can benefit from this approach.Trial registrationClinicalTrials.gov: NCT02116621, first registered 15 April 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0590-8) contains supplementary material, which is available to authorized users.

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Participatory sensing (PS) is a distributed data collection and analysis approach where individuals, acting alone or in groups, use their personal mobile devices to systematically explore interesting aspects of their lives and communities [Burke et al. 2006]. These mobile devices can be used to capture diverse spatiotemporal data through both intermittent self-report and continuous recording from on-board sensors and applications. Ohmage (http://ohmage.org) is a modular and extensible open-source, mobile to Web PS platform that records, stores, analyzes, and visualizes data from both prompted self-report and continuous data streams. These data streams are authorable and can dynamically be deployed in diverse settings. Feedback from hundreds of behavioral and technology researchers, focus group participants, and end users has been integrated into ohmage through an iterative participatory design process. Ohmage has been used as an enabling platform in more than 20 independent projects in many disciplines. We summarize the PS requirements, challenges and key design objectives learned through our design process, and ohmage system architecture to achieve those objectives. The flexibility, modularity, and extensibility of ohmage in supporting diverse deployment settings are presented through three distinct case studies in education, health, and clinical research.

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