Exercise therapy as a digital therapeutic for chronic disease management: consideration for clinical product development.

Digital exercise therapies (DET) have the potential to bridge existing care gaps for people living with chronic conditions. Acting as either a standalone, embedded within multi-modal lifestyle therapy, or adjunct to pharmacotherapy or surgery, evidence-based DETs can favorably impact the health of a rapidly growing population. Given the nascent nature of digital therapeutics, the regulatory landscape has yet to mature. As such, in the absence of clear guidelines clinical digital product developers are responsible for ensuring the DET adheres to fundamental principles such as patient risk management and clinical effectiveness. The purpose of this narrative review paper is to discuss key considerations for clinical digital product developers who are striving to build novel digital therapeutic (DTx) solutions and thus contribute towards standardization of product development. We herein draw upon DET as an example, highlighting the need for adherence to existing clinical guidelines, human-centered design and an intervention approach that leverages the Chronic Care Model. Specific topics and recommendations related to the development of innovative and scalable products are discussed which ultimately allow for differentiation from a basic wellness tool and integration to clinical workflows. By embodying a code of ethics, clinical digital product developers can adequately address patients' needs and optimize their own future digital health technology assessments including appropriate evidence of safety and efficacy.

[Economic evaluation of interdisciplinary pain rehabilitation. One IKR for rehabilitation gives eight IKR back to society].

INTRODUCTION: There is limited research on the long-term benefits of an interdisciplinary pain rehabilitation, even though short-term benefits have been well documented. The present study evaluated the effects of an interdisciplinary pain rehabilitation program with a three-year follow-up. A special emphasis was placed on economic evaluation of the treatment from a societal perspective. MATERIAL AND METHODS: The study was conducted at the chronic pain unit of the Reykjalundur rehabilitation center. Every fifth patient referred to the Reykjalundur Rehabiliation Center pain clinic was randomized to participate in this study. Data was collected over the course of 4,5 years with a three years follow-up. Finally, economic evaluation was conducted at the end of the research. RESULTS: After treatment patients experienced less pain, fear and avoidance, anxiety and depression symptoms and improved social functioning. Work ability increased from 36% to 47% at the end of rehabilitation and continued to rise to 57% at three year follow-up. Economic evaluation from a societal perspective showed that cost associated with the rehabilitation had leveled out in three years and continued throughout life. CONCLUSION: The results indicate that interdisciplinary rehabilitation for chronic pain has a positive impact on function and the experience of pain as well as positive psychosocial effect. An economic evaluation of the treatment shows that the rehabilitation is very cost effective and that each Icelandic krona (IKR) spent is returned eightfold back to society.