Combining non-pharmacological treatments with pharmacotherapies for neurological disorders: a unique interface of the brain, drug-device, and intellectual property.
ABSTRACT: Mobile medical applications (mHealth), music, and video games are being developed and tested for their ability to improve pharmacotherapy outcomes and medication adherence. Pleiotropic mechanism of music and gamification engages an intrinsic motivation and the brain reward system, supporting therapies in patients with neurological disorders, including neuropathic pain, depression, anxiety, or neurodegenerative disorders. Based on accumulating results from clinical trials, an innovative combination treatment of epilepsy seizures, comorbidities, and the medication non-adherence can be designed, consisting of antiepileptic drugs and disease self-management software delivering clinically beneficial music. Since creative elements and art expressed in games, music, and software are copyrighted, therefore clinical and regulatory challenges in developing copyrighted, drug-device therapies may be offset by a value proposition of the exclusivity due to the patent-independent protection, which can last for over 70?years. Taken together, development of copyrighted non-pharmacological treatments (e-therapies), and their combinations with pharmacotherapies, offer incentives to chronically ill patients and outcome-driven health care industries.
Project description:BACKGROUND:The United States spends more than US $100 billion annually on the impact of medication misuse. Serious games are effective and innovative digital tools for educating patients about positive health behaviors. There are limited systematic reviews that examine the prevalence of serious games that incorporate medication use. OBJECTIVE:This systematic review aimed to identify (1) serious games intended to educate patients about medication adherence, education, and safety; (2) types of theoretical frameworks used to develop serious games for medication use; and (3) sampling frames for evaluating serious games on medication use. METHODS:PubMed, Scopus, and Web of Science databases were searched for literature about medication-based serious games for patients. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed for article selection. RESULTS:Using PRISMA guidelines, 953 publications and 749 unique titles were identified from PubMed, Scopus, and Web of Science. A total of 16 studies featuring 12 unique serious games were included with components of medication adherence, education, and safety, published from 2003 to 2019. Of the 12 games included, eight serious games were tested in adolescents, three games were tested in young adults, and one game was tested in adults. Most studies (n=11) used small sample sizes to test the usability of serious games. Theoretical frameworks identified in the 12 serious games included information, motivation, and behavior theory; social cognitive theory; precede-proceed model; middle-range theory of chronic illness; adult learning theory; experiential learning theory; and the theory of reasoned action. Existing reviews explore serious games focused on the management of specific disease states, such as HIV, diabetes, and asthma, and on the positive impact of serious game education in each respective disease state. Although other reviews target broad topics such as health care gamification and serious games to educate health care workers, no reviews focus solely on medication use. Serious games were mainly focused on improving adherence, whereas medication safety was not widely explored. Little is known about the efficacy and usability of medication-focused serious games often because of small and nonrepresentative sample sizes, which limit the generalizability of existing studies. CONCLUSIONS:Limited studies exist on serious games for health that incorporate medication use. The findings from these studies focus on developing and testing serious games that teach patients about medication use and safety. Many of these studies do not apply a theoretical framework in the design and assessment of these games. In the future, serious game effectiveness could be improved by increasing study sample size and diversity of study participants, so that the results are generalizable to broader populations. Serious games should describe the extent of theoretical framework incorporated into game design and evaluate success by testing the player's retention of learning objectives.
Project description:Digital health technologies for people with epilepsy (PWE) include internet-based resources and mobile apps for seizure management. Since non-pharmacological interventions, such as listening to specific Mozart's compositions, cognitive therapy, psychosocial and educational interventions were shown to reduce epileptic seizures, these modalities can be integrated into mobile software and delivered by mobile medical apps as digital therapeutics. Herein, we describe: (1) a survey study among PWE about preferences to use mobile software for seizure control, (2) a rationale for developing digital therapies for epilepsy, (3) creation of proof-of-concept mobile software intended for use as an adjunct digital therapeutic to reduce seizures, and (4) broader applications of digital therapeutics for the treatment of epilepsy and other chronic disorders. A questionnaire was used to survey PWE with respect to preferred features in a mobile app for seizure control. Results from the survey suggested that over 90% of responders would be interested in using a mobile app to manage their seizures, while 75% were interested in listening to specific music that can reduce seizures. To define digital therapeutic for the treatment of epilepsy, we designed and created a proof-of-concept mobile software providing digital content intended to reduce seizures. The rationale for all components of such digital therapeutic is described. The resulting web-based app delivered a combination of epilepsy self-care, behavioral interventions, medication reminders and the antiseizure music, such as the Mozart's sonata K.448. To improve long-term patient engagement, integration of mobile medical app with music and multimedia streaming via smartphones, tablets and computers is also discussed. This work aims toward development and regulatory clearance of software as medical device (SaMD) for seizure control, yielding the adjunct digital therapeutic for epilepsy, and subsequently a drug-device combination product together with specific antiseizure medications. Mobile medical apps, music, therapeutic video games and their combinations with prescription medications present new opportunities to integrate pharmacological and non-pharmacological interventions for PWE, as well as those living with other chronic disorders, including depression and pain.
Project description:Cognitive decline is an important nonmotor symptom in Parkinson disease (PD). Unfortunately, very few treatment options are available. Recent research pointed to small positive effects of nonpharmacological cognitive training in PD. Most of these trainings are performed under supervision and solely computerized versions of (traditional) paper-pencil cognitive training programs, lacking rewarding gamification stimulants that could help to promote adherence. By describing 3 different self-invented ways of cognitive gaming in patients with PD, we aimed to raise awareness for the potential of gamified cognitive training in PD patients. In addition, we hoped to inspire the readers with our case descriptions, highlighting the importance of both personalization and cocreation in the development of games for health. In this viewpoint, we have presented 3 PD patients with different ages, with different disease stages, and from various backgrounds, who all used self-invented cognitive training, including elements of personalization and gamification. To indicate generalization into a larger PD population, the recruitment results from a recent cognitive game trial are added. The presented cases show similarities in terms of awareness of their cognitive decline and the ways this process could potentially be counteracted, by looking for tools to train their cognition. On the basis of the response of the recruitment procedure, there seems to be interest in gamified cognitive training in a larger PD population too. Gamification may add to traditional therapies in terms of personalization and adherence. Positive results have already been found with gamified trainings in other populations, and the cases described here suggest that PD is also an attractive area to develop and test gamified cognitive trainings. However, no results of gamified cognitive trainings in PD have been published to date. This suggests an unmet need in this area and may justify the development of gamified cognitive training and its evaluation, for which our considerations can be used.
Project description:Gamification involves incorporating elements of online games, such as points, leaderboards, and badges into non-game contexts, in order to improve engagement with both employees and consumers. The main point of this paper is, to sum up, what previous authors investigated in the field of Gamification. An analysis of the literature covering 50 papers from 2011 to 2016 was conducted, using Leximancer software, to determine and shape the main themes and concepts proposed in gamification papers. Answering our research question, "What guidelines may provide to future research, the key themes and concepts found in published scientific papers on gamification?", we conclude that the researchers identified eight themes (gamification; game; use; users; business; points; engagement; learning) and twenty-eight related concepts. The present systematic review contributes to establishing possible guidelines for prospective studies, based on the analyzed papers, considering particularly their 'Conclusions' and on the 'Future research' sections, integrating game design contents in business, learning and education. Further, highlights the usefulness of Leximancer for qualitative content analysis, in this field of research.
Project description:BACKGROUND:Strategies to improve medication adherence are widespread in the literature; however, their impact is limited in real practice. Few patients persistently engage long-term to improve health outcomes, even when they are aware of the consequences of poor adherence. Despite the potential of mobile phone apps as a tool to manage medication adherence, there is still limited evidence of the impact of these innovative interventions. Real-world evidence can assist in minimizing this evidence gap. OBJECTIVE:The objective of this study was to analyze the impact over time of a previously implemented digital therapeutic mobile app on medication adherence rates in adults with any chronic condition. METHODS:A retrospective observational study was performed to assess the adherence rates of patients with any chronic condition using Perx Health, a digital therapeutic that uses multiple components within a mobile health app to improve medication adherence. These components include gamification, dosage reminders, incentives, educational components, and social community components. Adherence was measured through mobile direct observation of therapy (MDOT) over 3-month and 6-month time periods. Implementation adherence, defined as the percentage of doses in which the correct dose of a medication was taken, was assessed across the study periods, in addition to timing adherence or percentage of doses taken at the appropriate time (±1 hour). The Friedman test was used to compare differences in adherence rates over time. RESULTS:We analyzed 243 and 130 patients who used the app for 3 months and 6 months, respectively. The average age of the 243 patients was 43.8 years (SD 15.5), and 156 (64.2%) were female. The most common medications prescribed were varenicline, rosuvastatin, and cholecalciferol. The median implementation adherence was 96.6% (IQR 82.1%-100%) over 3 months and 96.8% (IQR 87.1%-100%) over 6 months. Nonsignificant differences in adherence rates over time were observed in the 6-month analysis (Fr(2)=4.314, P=.505) and 3-month analysis (Fr(2)=0.635, P=.728). Similarly, the timing adherence analysis revealed stable trends with no significant changes over time. CONCLUSIONS:Retrospective analysis of users of a medication adherence management mobile app revealed a positive trend in maintaining optimal medication adherence over time. Mobile technology utilizing gamification, dosage reminders, incentives, education, and social community interventions appears to be a promising strategy to manage medication adherence in real practice.
Project description:This is a summary of current and emerging pharmacologic therapies utilized in the treatment of diabetic retinopathy (DR). Current therapies, such as ranibizumab, bevacizumab, triamcinolone acetonide, and fluocinolone acetonide, inhibit angiogenesis and inflammation and may be used alone or in combination with laser treatment. Emerging therapies aim to reduce oxidative stress or inhibit other signal transduction pathways, including the protein kinase C cascade and aldose reductase pathway. Future therapies may target other molecules crucial to the pathogenesis of DR, including hepatocyte growth factors and matrix metalloproteinase 9. Finally, the emergence of novel mechanisms of medication delivery may also be on the horizon.
Project description:BACKGROUND:Robot-assisted therapy has become a promising technology in the field of rehabilitation for poststroke patients with motor disorders. Motivation during the rehabilitation process is a top priority for most stroke survivors. With current advancements in technology there has been the introduction of virtual reality (VR), augmented reality (AR), customizable games, or a combination thereof, that aid robotic therapy in retaining, or increasing the interests of, patients so they keep performing their exercises. However, there are gaps in the evidence regarding the transition from clinical rehabilitation to home-based therapy which calls for an updated synthesis of the literature that showcases this trend. The present review proposes a categorization of these studies according to technologies used, and details research in both upper limb and lower limb applications. OBJECTIVE:The goal of this work was to review the practices and technologies implemented in the rehabilitation of poststroke patients. It aims to assess the effectiveness of exoskeleton robotics in conjunction with any of the three technologies (VR, AR, or gamification) in improving activity and participation in poststroke survivors. METHODS:A systematic search of the literature on exoskeleton robotics applied with any of the three technologies of interest (VR, AR, or gamification) was performed in the following databases: MEDLINE, EMBASE, Science Direct & The Cochrane Library. Exoskeleton-based studies that did not include any VR, AR or gamification elements were excluded, but publications from the years 2010 to 2017 were included. Results in the form of improvements in the patients' condition were also recorded and taken into consideration in determining the effectiveness of any of the therapies on the patients. RESULTS:Thirty studies were identified based on the inclusion criteria, and this included randomized controlled trials as well as exploratory research pieces. There were a total of about 385 participants across the various studies. The use of technologies such as VR-, AR-, or gamification-based exoskeletons could fill the transition from the clinic to a home-based setting. Our analysis showed that there were general improvements in the motor function of patients using the novel interfacing techniques with exoskeletons. This categorization of studies helps with understanding the scope of rehabilitation therapies that can be successfully arranged for home-based rehabilitation. CONCLUSIONS:Future studies are necessary to explore various types of customizable games required to retain or increase the motivation of patients going through the individual therapies.
Project description:BackgroundGamification is correlated with increased motivation and engagement of learners and is increasingly being incorporated into library instruction. Opportunities for librarians to learn and practice principles of gamification can be helpful for those desiring to incorporate gamification into instruction. This report describes the development and delivery of an interactive special content session at MLA ’18, the 2018 Medical Library Association annual meeting in Atlanta, Georgia, focusing on principles of low-tech game design for health sciences library classroom instruction.Case PresentationThe special content session, titled “Design, Play, Learn: A Special Content Session to Design a Game for Database Instruction,” was designed and delivered using multimodal instruction (e.g., flipped classroom, didactic component, active learning) that also incorporated principles of design thinking. A pre- and post-survey was given to all participants at the beginning and end of the session to measure confidence and desire to incorporate gamification into instruction and as a formative feedback indicator for instructors. Participants reported increased confidence and desire to use games for library instruction after participating in the session. A selection of games was uploaded to a shared content folder designed for course participants as an ongoing repository for ideas and communication.ConclusionsFor librarians who are interested in incorporating principles of gamification into library instruction, attending a relatively short hands-on workshop can facilitate learning and confidence around prototyping and creating games for use in library instruction. We intend to improve upon the workshop and offer it again in additional contexts, based on direct observations of the session and participant feedback.
Project description:Games and/or gamification seem to be a promising area for educational and health research. These strategies are being increasingly used for improving health indicators, even in educational settings; however, there is little information about these terms within the school to promote physical activity (PA). OBJECTIVE:the aim of this study is to describe a systematic review protocol of school-based interventions for promoting PA in pre-schoolers, children, and adolescent students using games and gamification. METHODS:This review protocol is registered in International prospective register of systematic reviews (PROSPERO) (CRD42019123521). Scientific databases include PubMed, Web of Science, SportDiscus, Cochrane Library, ERIC, and PsycINFO. A standardized procedure will be executed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses protocol (PRISMA-P) checklist for conducting systematic review protocols and the PICOS (Population, Interventions, Comparators, Outcomes, and Study design) tool to address an appropriate search strategy. Detailed information will be extracted, including a quantitative assessment using effect sizes to compare the interventions and a qualitative assessment using the Evaluation of Public Health Practice Projects (EPHPP) tool. CONCLUSION:This systematic review protocol contributes to establishing future systematic reviews using games and gamification strategies in school settings in order to examine their effect on PA outcomes among youth. Additionally, an update and clarification on the different terms in the school context have been included.
Project description:OBJECTIVE:Mobile phone-based interventions have been proven to be effective tools for smoking cessation, at least in the short term. Gamification, that is, the use of game-design elements in a non-game context, has been associated with increased engagement and motivation, critical success factors for long-term success of mobile Health solutions. However, to date, no app review has examined the use of gamification in smoking cessation mobile apps. Our review aims to examine and quantify the use of gamification strategies (broad principles) and tactics (on-screen features) among existing mobile apps for smoking cessation in the UK. METHODS:The UK Android and iOS markets were searched in February 2018 to identify smoking cessation apps. 125 Android and 15 iOS apps were tested independently by two reviewers for primary functionalities, adherence to Five A smoking cessation guidelines, and adoption of gamification strategies and tactics. We examined differences between platforms with χ2 tests. Correlation coefficients were calculated to explore the relationship between adherence to guidelines and gamification. RESULTS:The most common functionality of the 140 mobile apps we reviewed allowed users to track the days since/until the quit date (86.4%). The most popular gamification strategy across both platforms was performance feedback (91.4%). The majority of apps adopted a medium level of gamification strategies (55.0%) and tactics (64.3%). Few adopted high levels of gamification strategies (6.4%) or tactics (5.0%). No statistically significant differences between the two platforms were found regarding level of gamification (p>0.05) and weak correlations were found between adherence to Five A's and gamification strategies (r=0.38) and tactics (r=0.26). CONCLUSION:The findings of this review show that a high level of gamification is adopted by a small minority of smoking cessation apps in the UK. Further exploration of the use of gamification in smoking cessation apps may provide insights into its role in smoking cessation.