Medical App Treatment of Non-Specific Low Back Pain in the 12-month Cluster-Randomized Controlled Trial Rise-uP: Where Clinical Superiority Meets Cost Savings.

Purpose: Non-specific low back pain (NLBP) exerts a profound impact on global health and economics. In the era of Web 3.0, digital therapeutics offer the potential to improve NLBP management. The Rise-uP trial introduces a digitally anchored, general practitioner (GP)-focused back pain management approach with the Kaia back pain app as the key intervention. Here, we present the 12-months evaluation of the Rise-uP trial including clinical and economic outcomes, patient satisfaction and behavioral tracking analysis. Methods: The cluster-randomized controlled study (registration number: DRKS00015048) enrolled 1237 patients, with 930 receiving treatment according to the Rise-uP approach and 307 subjected to standard of care treatment. Assessments of pain, psychological state, functional capacity, and well-being (patient-reported outcome measures; PROMs) were collected at baseline, and at 3-, 6-, and 12-months follow-up intervals. Health insurance partners AOK, DAK, and BARMER provided individual healthcare cost data. An artificial intelligence (AI)-driven behavioral tracking analysis identified distinct app usage clusters that presented all with about the same clinical outcome. Patient satisfaction (patient-reported experience measures; PREMs) was captured at the end of the trial. Results: Intention-to-treat (ITT) analysis demonstrated that the Rise-uP group experienced significantly greater pain reduction at 12 months compared to the control group (IG: -46% vs CG: -24%; p < 0.001) with only the Rise-uP group achieving a pain reduction that was clinically meaningful. Improvements in all other PROMs were notably superior in patients of the Rise-uP group. The AI analysis of app usage discerned four usage clusters. Short- to long-term usage, all produced about the same level of pain reduction. Cost-effectiveness analysis indicated a substantial economic benefit for Rise-uP. Conclusion: The Rise-uP approach with a medical multimodal back pain app as the central element of digital treatment demonstrates both, clinical and economic superiority compared to standard of care in the management of NLBP.

Digital psychosocial interventions for individuals with spinal cord injury: a scoping review.

Objective: To provide an overview of the digital mental health care landscape for individuals with spinal cord injury (SCI). Methods: PubMed, PsycInfo, and PSYNDEX were searched for articles meeting the following criteria: (1) article written in English or German; (2) digital psychosocial intervention; (3) SCI only; (4) treatment of individuals with SCI and not their relatives or caregivers. Records were screened by title and abstract and records meeting the inclusion criteria were obtained for full text screening. The references of identified articles were screened to find further relevant articles. The literature search was updated before submission. Risk of Bias was assessed by using the Cochrane risk-of-bias tool for randomized trials (RoB 2) and a narrative synthesis was conducted. Results: Ten randomized-controlled trials (RCT) and ten non-randomized-controlled trials were identified and compared in this review, evaluating twelve internet- and mobile-based interventions, five smartphone apps, and three virtual reality applications. The interventions were primarily used as stand-alone aftercare programs. While some were not based on any theory, cognitive behavioral therapy mostly served as the theoretical basis for the online interventions. The extent of human support also varied greatly between the studies. The number of intervention modules ranged between 2 and 72. There were also major differences in outcome variables and effects. A meta-analytical evaluation of the data was not conducted due to heterogeneity of studies. Conclusion: Digital applications to promote the psychosocial health of individuals with SCI are an emerging field of research with many treatment approaches still to come. First high quality RCT studies report promising results. Unfortunately, not all studies are of high quality or the interventions have been insufficiently adapted to the needs of people with SCI. Therefore, more research is needed to further develop applications, and to generalize and test the effects found in the long term.

A Smartphone App for Real-Time Assessment of Malaria Prophylaxis Adverse Events.

Background: Growth of international travel to malarial areas over the last decades has contributed to more travelers taking malaria prophylaxis. Travel-related symptoms may be wrongly attributed to malaria prophylaxis and hinder compliance. Here, we aimed to assess the frequency of real-time reporting of symptoms by travelers following malaria prophylaxis using a smartphone app. Method: Adult international travelers included in this single-center study (Barcelona, Spain) used the smartphone Trip Doctor® app developed by our group for real-time tracking of symptoms and adherence to prophylaxis. Results: Six hundred four (n = 604) international travelers were included in the study; 74.3% (449) used the app daily, and for one-quarter of travelers, malaria prophylaxis was prescribed. Participants from the prophylaxis group traveled more to Africa (86.7% vs. 4.3%; p < 0.01) and to high travel medical risk countries (60.8% vs. 18%; p < 0.01) and reported more immunosuppression (30.8% vs. 23.1% p < 0.01). Regarding symptoms, no significant intergroup differences were observed, and no relationship was found between the total number of malarial pills taken and reported symptoms. Conclusions: In our cohort, the number of symptoms due to malaria prophylaxis was not significantly higher than in participants for whom prophylaxis was not prescribed, and the overall proportion of symptoms is higher compared with other studies.

User Perceptions and Use of Decision Support Medical Apps Among Medical Students: Cross-Sectional Study.

We aimed to assess medical students' use of decision-support medical apps and evaluate their perception of app use. A cross-sectional multi-center observational study was conducted among medical students with and without a medical informatics course as part of their undergraduate medical curriculum. We assessed trust, perceptions, patient impression, reliability, and comfort using an online survey. A total of 439 responses were received. There were significant differences between the two groups when indicating which apps, they trust. Students agreed that using apps enhanced knowledge (91%), saved time (88%), improved patient care (85%), and increased diagnostic accuracy (82%). Students indicated that patients would think that students didn't know what they were doing (63%) or students were fresh out of training (53%) when using apps in the presence of patients. Incorporating medical app usage as part of learning may increase trust and comfort with using medical apps in medical practice.

Application of artificial intelligence in medical technologies: A systematic review of main trends.

Objective: Artificial intelligence (AI) has been increasingly applied in various fields of science and technology. In line with the current research, medicine involves an increasing number of artificial intelligence technologies. The introduction of rapid AI can lead to positive and negative effects. This is a multilateral analytical literature review aimed at identifying the main branches and trends in the use of using artificial intelligence in medical technologies. Methods: The total number of literature sources reviewed is n = 89, and they are analyzed based on the literature reporting evidence-based guideline PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) for a systematic review. Results: As a result, from the initially selected 198 references, 155 references were obtained from the databases and the remaining 43 sources were found on open internet as direct links to publications. Finally, 89 literature sources were evaluated after exclusion of unsuitable references based on the duplicated and generalized information without focusing on the users. Conclusions: This article is identifying the current state of artificial intelligence in medicine and prospects for future use. The findings of this review will be useful for healthcare and AI professionals for improving the circulation and use of medical AI from design to implementation stage.

Apps in healthcare and medical research; European legislation and practical tips every healthcare provider should know.

BACKGROUND: The use of apps in healthcare and medical research is increasing. Apps in healthcare may be beneficial to patients and healthcare professionals, but their use comes with potential risks. How to use apps in clinical care is not standard part of medical training, resulting in a lack of knowledge. As healthcare professionals and their employers can be held accountable for the wrongful use of medical apps, this situation is undesirable. This article addresses the most important European legislation regarding medical apps from the perspective of healthcare providers. METHODS: This review provides an overview of current and changing regulations, focusing on apps used in healthcare and medical research. Three topics are discussed: 1) the relevant European legislation and its enforcement, 2) the responsibilities and liability of the medical professional when using these apps, and 3) an overview of the most practical considerations medical professionals should know when using or building a medical app. RESULTS: When using and developing medical apps, data privacy must be guaranteed according to the GDPR guidelines. Several international standards make it easier to comply with the GDPR, such as ISO/IEC 27001 and 27002. Medical Devices Regulation was implemented on May 26, 2021, and as a result, medical apps will more often qualify as medical devices. The important guidelines for manufacturers to comply with Medical Devices Regulation are ISO 13485, ISO 17021, ISO 14971 and ISO/TS 82304-2. CONCLUSION: The use of medical apps in healthcare and medical research can be beneficial to patients, medical professionals, and society as a whole. This article provides background information on legislation and a comprehensive checklist for anyone wanting to start using or building medical apps.

The Usage of Digital Health Mobile-Based Applications among Saudi Population.

This study aimed at assessing the extent to which the general Saudi population has embraced digital health medical applications to meet their health-related needs so that the Saudi Ministry of Health and government can appropriately be guided on scaling up digital health across the country. As such, this study was guided by the question of to what extent the Saudi people use digital health mobile-based applications. This was a cross-sectional study utilizing snowballing sampling approach. Frequencies, Chi-square, and Spearman rank correlation statistics were used to offer descriptive and inferential analysis of the variables. The majority of the participants were economically able to afford smart devices that have medical apps, had at least an app on such devices, and highly regarded the benefits of the apps. Unfortunately, their understanding of how to use such apps was limited, and this posed a barrier to embracing digital health alongside difficulty downloading apps and medical ethical concerns. Although there is a willingness, extra effort is needed from the Saudi Ministry of Health and the government to promote the uptake of digital health in Saudi Arabia.

[Social media, are they necessary?] / Social Media, muss das sein?

Many areas of medicine are already doing it, but cardiac surgery in Germany is still very reluctant. We are talking about social media. Digital platforms are increasingly becoming useful tools in everyday life, for example when it comes to patient education and continuing medical education. The visibility of your own paper can also be increased many times over in a very short time. In addition to the positive effects, there are also negative effects. To ensure that the benefits outweigh the negative aspects and that every doctor knows what he or she must adhere to, the German Medical Association has defined clear rules. Use it or lose it.

mHealth app usage amongst paediatric department doctors in South Africa.

Background: Smartphone and mobile health (mHealth) applications (apps) have become an integral part of the day-to-day function of healthcare professionals, allowing quick, comprehensive, and up-to-date access to current clinical guidelines and other reference material. Objective: To evaluate the extent and nature of use of mHealth apps by paediatric department doctors in South Africa. Methods: E-mails requesting study participation were sent out to 285 paediatric department doctors employed at six hospitals affiliated to the University of the Witwatersrand. Willing participants were directed to complete the online study questionnaire. Results: A total of 150 respondents completed the questionnaire. All respondents owned a mobile device and already had one or more mHealth apps, 95.3% were unaware of any regulatory body responsible for regulating the use of mHealth apps, 86.0% did not have access to free Wi-Fi at work and 87.3% used an mHealth app at least once daily. Drug dosing (81.3%), diagnostic (59.3%) and clinical decision-making (44.7%) apps were the most common app categories with Medscape® (62.0%) and EMGuidance® (41.3%) being the most frequently used apps. Peer recommendation (76.0%), app credibility (74.0%) and app functionality (66.0%) were the most common factors that were considered by respondents prior to downloading or using an mHealth app. Conclusion: Medical apps are frequently used among paediatric medical doctors of all ranks. Drug dosing, diagnostic and clinical decision-making apps are the most common app categories in use. Improved awareness of the regulations pertaining to the use of mHealth apps amongst doctors is required.

Development and evaluation of a regional diabetes service App for patient education, self-management and clinic engagement.

BACKGROUND: We created a free NHS App to deliver all patient information on type 1 diabetes to help promote self-management. This became an invaluable way of getting information to patients during the pandemic when all face-to-face clinics were suspended. The aim of this study is to investigate patient perceptions of the App. METHODS: A questionnaire-based cross-sectional study was designed by the diabetes team to obtain quantitative data. RESULTS: The mean score of patient accessibility to diabetes information and services before using the App was 5.1, and after using the App was 8.8 (p < 0.001). Among the patients, 91% would recommend the App, 57.2% agree the App helps them schedule and attend their screening appointments and 73.7% agree the App has improved their self-management of type 1 diabetes. CONCLUSION: Patients agree the App has improved accessibility to diabetes information and services and has helped with self-management of their condition. Patients are likely to recommend the App to friends and family who have diabetes.

Feasibility and Quality Validation of a Mobile Application for Enhancing Adherence to Opioids in Sickle Cell Disease.

Prescription opioid nonadherence, specifically opioid misuse, has contributed to the opioid epidemic and opioid-related mortality in the US. Popular methods to measure and control opioid adherence have limitations, but mobile health, specifically smartphone applications, offers a potentially useful technology for this purpose. We developed, tested, and validated the OpPill application using the Mobile Applications Rating Scale (MARS), a validated tool for assessing the quality of mobile health apps. The MARS contains four scales (range of each scale = 0-4) that rate Engagement, Functionality, Aesthetics, and Information Quality. It also assesses subjective quality, relevance, and overall application impact. Our application was built to be a mobile monitoring and reporting system intended to enhance opioid adherence by collecting data and providing systematic feedback on pain and opioid use. Patients (n = 28) all had one of various SCD genotypes, were ages 19 to 59 years (mean 36.56), 53.6% were female, and 39.3% had completed some college. Patients rated the OpPill application highly on all four scales: Engagement, 3.93 ± 0.73; Functionality, 4.54 ± 0.66; Aesthetics, 3.92 ± 0.81; Information, 3.91 ± 0.87. The majority of patients found the application to be relevant for their care. A total of 96% reported the information within the app was complete, while 4% estimated the information to be minimal or overwhelming. Patients (91.7%) overwhelmingly reported that the quality of information as it pertained to SCD patients was relevant; only 8.3% found the application to be poorly relevant to SCD. Similarly, patients (91.7%) overwhelmingly rated both the application's performance and ease of use positively. The large majority of participants (85.7%) found the application to be interesting to use, while 74% found it entertaining. All users found the application's navigation to be logical and accurate with consistent and intuitive gestural design. We conclude that the OpPill application, specifically targeted to monitor opioid use and pain and opioid behavior in patients with Chronic Non-Cancer Pain, was feasible and rated by SCD patients as easy-to-use using a validated rating tool.

A Study of Mobile Medical App User Satisfaction Incorporating Theme Analysis and Review Sentiment Tendencies.

Mobile medicine plays a significant role in optimizing medical resource allocation, improving medical efficiency, etc. Identifying and analyzing user concern elements from active online reviews can help to improve service quality and enhance product competitiveness in a targeted manner. Based on the latent Dirichlet allocation (LDA) topic model, this study carries out a topic-clustering analysis of users' online comments and builds an evaluation index system of mobile medical users' satisfaction by using grounded theory. After that, the evaluation information of users is obtained through an emotional analysis of online comments. Then, in order to fully consider the uncertainty of decision makers' evaluations, rough number theory and the fuzzy comprehensive evaluation method are used to confirm the conclusions of experts and indicators and to evaluate the satisfaction of mobile medical users. The empirical results show that users are satisfied with the service quality and content quality of mobile medical apps, and less satisfied with the management and technology qualities. Therefore, this paper puts forward corresponding countermeasures from the aspects of strengthening safety supervision, strengthening scientific research, strengthening information audit, attaching importance to service quality management and strengthening doctors' sense of gain. This study uses text mining for index extraction and satisfaction analysis of online reviews to quantitatively evaluate user satisfaction with mobile medical apps, providing a reference for the improvement of mobile medical apps. However, there are still certain shortcomings in the current study, and subsequent studies can screen false reviews for a deeper study of online review information.

Telemedicine for international travelers through a Smartphone-based monitoring platform (Trip Doctor®).

BACKGROUND: Overall, more than 50% of international travelers develop symptoms while traveling and 55% of them seek medical assistance during the trip. We conducted a study to evaluate the usefulness of a Smartphone app called TRIP Doctor® to provide telemedicine to international travelers. METHODS: Participants over 18 years old attending our travel clinic at Hospital Clinic in Barcelona were invited to participate during 2017-2019. After downloading the app, the health status of the traveler was monitored on a daily basis, providing specific medical advice and offering remote contact with specialized physicians through an integrated chat, if needed. RESULTS: From 449 users, 59 (13%) contacted for medical assistance through the app during the trip. Main reasons for telemedicine were diarrhea (25.7%), skin conditions (19.7%) and fever (12.1%). Among patients who contacted, 90% of the travelers did not require to be referred to a local doctor. Symptomatic treatment was the main treatment prescribed (38%). In a 14.7% of the cases a follow-up was not required, a 63.2% recovered and 22.1% were loss of follow-up. After a multivariate analysis, duration of trip >14 days was found to be the only factor associated with the use of telemedicine (OR 2.2, CI 95% 1.1-4.5, p = 0.03). CONCLUSION: In conclusion, travelers using telemedicine travelled for longer periods of time and mostly contacted for mild symptoms which could be solved successfully by remote assistance with our specialized doctors.

Recommendations for developing a lifecycle, multidimensional assessment framework for mobile medical apps.

Digital health and mobile medical apps (MMAs) have shown great promise in transforming health care, but their adoption in clinical care has been unsatisfactory, and regulatory guidance and coverage decisions have been lacking or incomplete. A multidimensional assessment framework for regulatory, policymaking, health technology assessment, and coverage purposes based on the MMA lifecycle is needed. A targeted review of relevant policy documents from international sources was conducted to map current MMA assessment frameworks, to formulate 10 recommendations, subsequently shared amongst an expert panel of key stakeholders. Recommendations go beyond economic dimensions such as cost and economic evaluation and also include MMA development and update, classification and evidentiary requirements, performance and maintenance monitoring, usability testing, clinical evidence requirements, safety and security, equity considerations, organizational assessment, and additional outcome domains (patient empowerment and environmental impact). The COVID-19 pandemic greatly expanded the use of MMAs, but temporary policies governing their use and oversight need consolidation through well-developed frameworks to support decision-makers, producers and introduction into clinical care processes, especially in light of the strong international, cross-border character of MMAs, the new EU medical device and health technology assessment regulations, and the Next Generation EU funding earmarked for health digitalization.

Requirements for an app from the perspective of patients in plastic and reconstructive surgery.

BACKGROUND: Along with the higher availability of Internet, worldwide access and the use of cell phones, the demands of patients for digitalized medical care have increased. METHODS: A questionnaire-based prospective study of 405 patients was conducted to investigate their expectations and requirements of app-based "mHealth" applications. RESULTS: "Behavioral guidance after surgery," "overview of personal findings," and "contact with the treating physician" were the most important factors. In contrast, "exchange with other patients" seemed to be of less importance. CONCLUSION: There is a need for health-oriented apps among patients undergoing plastic and reconstructive surgery, especially with the requirements for individual postoperative care.

A Platform and Multisided Market for Translational, Software-Defined Medical Procedures in the Operating Room (OP 4.1): Proof-of-Concept Study.

BACKGROUND: Although digital and data-based technologies are widespread in various industries in the context of Industry 4.0, the use of smart connected devices in health care is still in its infancy. Innovative solutions for the medical environment are affected by difficult access to medical device data and high barriers to market entry because of proprietary systems. OBJECTIVE: In the proof-of-concept project OP 4.1, we show the business viability of connecting and augmenting medical devices and data through software add-ons by giving companies a technical and commercial platform for the development, implementation, distribution, and billing of innovative software solutions. METHODS: The creation of a central platform prototype requires the collaboration of several independent market contenders, including medical users, software developers, medical device manufacturers, and platform providers. A dedicated consortium of clinical and scientific partners as well as industry partners was set up. RESULTS: We demonstrate the successful development of the prototype of a user-centric, open, and extensible platform for the intelligent support of processes starting with the operating room. By connecting heterogeneous data sources and medical devices from different manufacturers and making them accessible for software developers and medical users, the cloud-based platform OP 4.1 enables the augmentation of medical devices and procedures through software-based solutions. The platform also allows for the demand-oriented billing of apps and medical devices, thus permitting software-based solutions to fast-track their economic development and become commercially successful. CONCLUSIONS: The technology and business platform OP 4.1 creates a multisided market for the successful development, implementation, distribution, and billing of new software solutions in the operating room and in the health care sector in general. Consequently, software-based medical innovation can be translated into clinical routine quickly, efficiently, and cost-effectively, optimizing the treatment of patients through smartly assisted procedures.

EncephalApp Stroop Test for covert hepatic encephalopathy screening in Tunisian cirrhotic patients.

Background: Covert hepatic encephalopathy (CHE) is underdiagnosed and is difficult to detect. The EncephalApp Stroop test is validated for its screening. The aim of the study was to define Tunisian norms for the test based on healthy controls norms and to estimate the prevalence of CHE in cirrhotic Tunisian patients. Methods: A prospective, multicenter, cross-sectional study was conducted. Ambulatory or hospitalized cirrhotic patients aged 40 years and over were recruited at 11 centers. Healthy subjects aged 40 years and over were recruited at 8 centers. We used a translated Arabic version of the streamlined EncephalApp Stroop test. The task has two components: "Off" and "On" state depending on the discordance or concordance of the stimuli. Results: 142 patients were included. The mean age was 57.26 years [40-86]. 40 (28.17%) of cirrhotic patients who were included were diagnosed as having a minimal hepatic encephalopathy or CHE. Among the ineligible patients, 22 had overt hepatic encephalopathy. If we consider these patients, the overall prevalence rate of CHE was around 24.39% in cirrhotic patients. It was more frequent in women (34.21% vs 25.96%), and in patients whose level of school education is between 6 and 13 years. Its prevalence does not appear to be affected by gender, MELD score, etiology of cirrhosis and age group of patients, as these variables were independent with respective p according to the chi-square test 0.413; 0.736; 0.663 and 0.1. The stroop times (On / Off and On + Off) correlated significantly with each other, are associated significantly and positively with age (respective Pearson coefficients: 0.578; 0.567 and 0.6). The more the age increases, the more the stroop response times increases (p > 10 -3). Conclusions: EncephalApp Stroop test was an efficient screening tool for CHE in Tunisian cirrhotic patients.

Effectivness of specific mobile health applications (mHealth-apps) in gestational diabtetes mellitus: a systematic review.

BACKGROUND: Gestational diabetes mellitus (GDM) emerges worldwide and is closely associated with short- and long-term health issues in women and their offspring, such as pregnancy and birth complications respectively comorbidities, Type 2 Diabetes (T2D), metabolic syndrome as well as cardiovascular diseases. Against this background, mobile health applications (mHealth-Apps) do open up new possibilities to improve the management of GDM. Therefore, we analyzed the clinical effectiveness of specific mHealth-Apps on clinical health-related short and long-term outcomes in mother and child. METHODS: A systematic literature search in Medline (PubMed), Cochrane Library, Embase, CINAHL and Web of Science Core Collection databases as well as Google Scholar was performed. We selected studies published 2008 to 2020 analyzing women diagnosed with GDM using specific mHealth-Apps. Controlled clinical trials (CCT) and randomized controlled trials (RCT) were included. Study quality was assessed using the Effective Public Health Practice Project (EPHPP) tool. RESULTS: In total, n = 6 publications (n = 5 RCTs, n = 1 CCT; and n = 4 moderate, n = 2 weak quality), analyzing n = 408 GDM patients in the intervention and n = 405 in the control groups, were included. Compared to control groups, fasting blood glucose, 2-h postprandial blood glucose, off target blood glucose measurements, delivery mode (more vaginal deliveries and fewer (emergency) caesarean sections) and patient compliance showed improving trends. CONCLUSION: mHealth-Apps might improve health-related outcomes, particularly glycemic control, in the management of GDM. Further studies need to be done in more detail.

TELERA-Asynchronous TELEmedicine for Patients With Rheumatoid Arthritis: Study Protocol for a Prospective, Multi-Center, Randomized Controlled Trial.

Innovative strategies are needed to adequately assess and monitor disease activity of patients with rheumatoid arthritis (RA) in times of scarce appointments. The aim of the TELERA study is to evaluate the feasibility and performance of asynchronous telemedicine visits based on patient-generated data and patient's drug history. RA patients use a medical app, ABATON, that captures the results of a self-performed quick CRP-test, joint-count, and electronic patient-reported outcomes in between visits. This is a prospective, multi-center, randomized controlled trial performed in four German university centers. The estimated sample size is 120 patients. The main outcome is the agreement of rheumatologists' treatment decisions based on asynchronous telemedicine patient-generated data with traditional in-person rheumatology clinic-based decisions and with patient suggestions. The TELERA trial will provide evidence regarding the implementation of remote care in rheumatology. Clinical Trial Registration: This clinical trial was registered at German Registry for Clinical Trials (DRKS). http://www.drks.de/DRKS00016350, identifier: DRKS00024928.