No full-text available
To read the full-text of this research,
you can request a copy directly from the authors.
DNVF-Memorandum – Gesundheits- und Medizin-Apps (GuMAs)
Abstract
Zusammenfassung
Mit der Nutzung von Gesundheits- und Medizin-Apps sind große Erwartungen an eine Verbesserung der Qualität und Effizienz von Präventions- und Versorgungskonzepten verknüpft. In weiten Bevölkerungsschichten ist die Bereitschaft zur Nutzung groß. Es fehlt jedoch belastbare Evidenz, um ausgehend vom derzeitigen, weitgehend unregulierten Angebot, Bedarf, Qualität und Sicherheit dieser Anwendungen einschätzen zu können. Aus diesem Grund adressiert die AG Digital Health im vorliegenden Memorandum wichtige Fragestellungen wie Angebot, objektiven Bedarf und Nettonutzen von Gesundheits- und Medizin-Apps (GuMAs), ethische Standards, Risiken und GuMAs als Forschungsressource, die von der Versorgungsforschung u. a. durch geeignete methodische Ansätze untersucht und beantwortet werden sollten. Diese Fragestellungen beziehen sich auf die Aspekte Patientensicherheit, Prozess- und Ergebnisqualität, versorgungsrelevante Aspekte digitaler Anwendungen und deren Einsatz in und für die wissenschaftliche Forschung.
... Das Digitale-Versorgung-Gesetz ermöglicht nun aber auch die Erstattung vielfältiger weiterer digitaler Technologien. Dabei muss unterschieden werden zwischen mobilen Apps zur Überwachung der eigenen Gesundheit und Fitness, die Anwendungen des zwei-ten Gesundheitsmarktes darstellen oder auch als Lifestyle-Apps einzuschätzen sind, und mobilen medizinischen Apps in Form von Medizinprodukten, deren Kosten bedingt durch das Digitale-Versorgung-Gesetz ab 2020 von den Krankenkassen erstattet werden können (Kramer et al. 2019). ...
... So ist davon auszugehen, dass immer mehr digitale Applikationen zur Förderung des Selbstmanagements eingesetzt werden. Sofern deren Qualität, Wirksamkeit und Sicherheit aufgrund nicht vorhandener oder qualitativ unzureichender Evidenz unklar ist, besteht das Risiko, dass Fehlentscheidungen mit negativen Auswirkungen auf die Gesundheit der Nutzerinnen und Nutzer getroffen werden und dies wiederum zu höheren Ausgaben in der (Regel-)Versorgung führt (Kramer et al. 2019). ...
... eher in dem Bereich der medizinischen Apps verortet werden können (Statista 2020). Dies ist bei der Bewertung von E-Health-Anwendungen eine wichtige Unterscheidung, denn neben den ganzen Lifestyle-Angeboten, zu denen eben auch Gesundheits-Apps gehören, gibt es auch mobile Anwendungen, die einen direkten medizinischen Bezug haben, also für Diagnostik und Therapie unterstützend eingesetzt werden können (Kramer et al. 2019). Für Männer, die den Kontakt zu Ärztinnen und Ärzten scheuen und auch weniger bereits sind an Maßnahmen der Prävention oder Gesundheitsförderung teilzunehmen, können solche Anwendungen unter Einbezug der Digitalisierung sicherlich einen gewinnbringenden Zugangsweg darstellen. ...
... Digital interventions that do not require face-to-face contact may play an important role in improving public mental health at times of infection prevention and control measures. They can be broadly grouped as telemedicine and internet-based interventions (hereafter eHealth interventions) [7] and app-based mobile health (mHealth) interventions delivered using smartphones or other mobile devices [8]. These interventions provide a unique opportunity for delivering low-threshold, public mental health care tailored to individual needs and contexts in daily life, outside the clinic [9], even under the restrictive conditions of the COVID-19 pandemic. ...
... For this, PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses [21]) was used as a guideline for reporting findings. In line with the current state of the art in the development and evaluation of complex digital mental health interventions [8], the following criteria to review the available evidence were used: theoretical and evidence base, quality assessments from the user perspective (ie, acceptability, usability, satisfaction), safety, effectiveness, and cost-effectiveness. ...
... This primarily includes evidence-based procedures such as cognitive-behavioral therapy (CBT) or third-wave CBT [23,25,26]. In contrast to digital interventions developed by research groups, prominent mHealth apps available in major app stores do often not provide information on the theoretical or empirical base of their content [8,[27][28][29]. Some mHealth apps may even be harmful and hinder healing processes (eg, asking users to do tasks that are too difficult to complete, presenting means for self-harm as well as lethal means, triggering unwanted distressing memories) [8,27,28]. ...
Background:
Accumulating evidence suggests the COVID-19 pandemic has negative effects on public mental health. Digital interventions that have been developed and evaluated in recent years may be used to mitigate the negative consequences of the pandemic. However, evidence-based recommendations on the use of existing telemedicine and internet-based (eHealth) and app-based mobile health (mHealth) interventions are lacking.
Objective:
The aim of this study was to investigate the theoretical and empirical base, user perspective, safety, effectiveness, and cost-effectiveness of digital interventions related to public mental health provision (ie, mental health promotion, prevention, and treatment of mental disorders) that may help to reduce the consequences of the COVID-19 pandemic.
Methods:
A rapid meta-review was conducted. The MEDLINE, PsycINFO, and CENTRAL databases were searched on May 11, 2020. Study inclusion criteria were broad and considered systematic reviews and meta-analyses that investigated digital tools for health promotion, prevention, or treatment of mental health conditions and determinants likely affected by the COVID-19 pandemic.
Results:
Overall, 815 peer-reviewed systematic reviews and meta-analyses were identified, of which 83 met the inclusion criteria. Our findings suggest that there is good evidence on the usability, safety, acceptance/satisfaction, and effectiveness of eHealth interventions. Evidence on mHealth apps is promising, especially if social components (eg, blended care) and strategies to promote adherence are incorporated. Although most digital interventions focus on the prevention or treatment of mental disorders, there is some evidence on mental health promotion. However, evidence on process quality, cost-effectiveness, and long-term effects is very limited.
Conclusions:
There is evidence that digital interventions are particularly suited to mitigating psychosocial consequences at the population level. In times of physical distancing, quarantine, and restrictions on social contacts, decision makers should develop digital strategies for continued mental health care and invest time and efforts in the development and implementation of mental health promotion and prevention programs.
... It is especially important, precisely for heart failure patients who are often elderly, to consider the age-specific aspects of cognition, perception and behavior in the user-centered design approach to telemedicine applications [13]. Just as in the development of health and medical apps, user expectations [14] or acceptance prior to actual use [11], and the needs of potential future users should be identified a priori in order to include them in the development [14]. Implementation strategies can then be developed to enable elderly patients (>70 years) to quickly adjust to the telemonitoring and integrate it into their daily lives and routines [15]. ...
... It is especially important, precisely for heart failure patients who are often elderly, to consider the age-specific aspects of cognition, perception and behavior in the user-centered design approach to telemedicine applications [13]. Just as in the development of health and medical apps, user expectations [14] or acceptance prior to actual use [11], and the needs of potential future users should be identified a priori in order to include them in the development [14]. Implementation strategies can then be developed to enable elderly patients (>70 years) to quickly adjust to the telemonitoring and integrate it into their daily lives and routines [15]. ...
Home-based telemonitoring in heart failure patients can reduce all-cause mortality and the relative risk of heart failure-related hospitalization compared to standard care. However, technology use depends, among other things, on user acceptance, making it important to include potential users early in development. In a home-based healthcare project (a feasibility project) a participatory approach was chosen in preparation for future development of contactless camera-based telemonitoring in heart disease patients. The project study patients (n = 18) were surveyed regarding acceptance and design expectations, and acceptance-enhancing measures and design suggestions were then drawn from the results. The study patients corresponded to the target group of potential future users. 83% of respondents showed high acceptance. 17% of those surveyed were more skeptical with moderate or low acceptance. The latter were female, mostly living alone, and without technical expertise. Low acceptance was associated with a higher expectation of effort and lower perception of self-efficacy and lower integratability into daily rhythms. For the design, the respondents found independent operation of the technology very important. Furthermore, concerns were expressed about the new measuring technology, e.g., anxiety about constant surveillance. The acceptance of a new generation of medical technology (contactless camera-based measuring technology) for telemonitoring is already quite high in the surveyed group of older users (60+). Specific user expectations concerning design should be considered during development to increase acceptance by potential users even more.
... Zugleich könnte die Steuerung von Ressourcen optimiert und die Innovation in der Entwicklung von Arzneimitteln und Medizinprodukten befördert werden [1]. Neben ersten Publikationen stehen valide wissenschaftliche Belege noch aus -hier kann die Versorgungsforschung wichtige Beiträge zur Generierung einer Evidenzbasis leisten [2][3][4]. Hierzu gründete sich im Jahr 2016 eine Arbeitsgruppe (AG) "Digital Health" innerhalb des Deutschen Netzwerks für Versorgungsforschung (DNVF) u. a. auch, um den Vorstand bei der Kommentierung von Gesetzesentwürfen zu unterstützen. Die Liste der Gesetze ist lang: Das eHealth-Gesetz für die sichere Kommunikation zwischen Leistungserbringern, insbesondere den Aufbau der Telematikinfrastruktur, der elektronischen Patientenakte und des eRezeptes [5], das Digitale Versorgung-Gesetz (12/2019), das digitale Innovationen in Therapie und Diagnostik über ein Fast-Track-Verfahren schnell zum Patienten und digitale Anwendungen als Kassenleistung in die Versorgung bringen soll [6], das Patientendatenschutzgesetz (PDSG 10/2020), das die Datennutzung und Datenspende innerhalb der ePA regelt, die seit Januar 2021 allen gesetzlich Versicherten als Satzungsleistung zusteht [7], sowie das Krankenhauszukunftsgesetz (KHZG 10/2020), das Mittel für die Finanzierung der digitalen Infrastrukturen in stationären Einrichtungen bereitstellt [8]. ...
... Die methodische Weiterentwicklung der Nutzenbewertung von komplexen digitalen Interventionen, wie es z. B. fast immer bei der Anwendung von digitalen Gesundheitsanwendungen (DiGA) der Fall ist, sind bisher ein Fokus der AG Digital Health [3,4]. Das sog. ...
Zusammenfassung
Ziel der Studie Die digitale Transformation im Gesundheitswesen ist auch für die Versorgungsforschung von elementarer Bedeutung. Daher sollten Experten und Expertinnen Themenschwerpunkte für eine mittelfristige Strategie des Deutschen Netzwerks für Versorgungsforschung konsentieren und priorisieren sowie eine allgemeine Entwicklung von Digital Health im Kontext der Versorgungsforschung einordnen.
Methodik Im Zeitraum von April bis September 2018 wurden die Arbeitsgruppen „Digital Health“ und „Validierung und Linkage von Sekundärdaten“ des Deutschen Netzwerk Versorgungsforschung mit dem methodischen Ansatz einer Delphi Studie zur Online-gestützten Abgabe ihrer Expertise gebeten. Dafür wurde ein mehrstufiges modifiziertes Delphi-Verfahren mit quantitativen und qualitativen Ansätzen gewählt. Initial wurde aus den veröffentlichten Positionspapieren zu digitalen Gesundheitsanwendungen und Medizin-Apps des Netzwerks ein erster Thesenkatalog ausgearbeitet. Insgesamt konnten 131 Statements formuliert werden. Das finale Erhebungsinstrument umfasste Fragen zum biografischen Hintergrund der Teilnehmer*innen, 42 entwickelte Items (33 Statements und 8 offene Fragen) und ein Freitextfeld, um weitere Aspekte zu ergänzen. Die Thesenbewertung erfolgte mit einer fünfstufigen Likert-Skala. Bei einem Zustimmungsgrad ab 75% wurde ein Statement angenommen.
Ergebnisse Von den 110 potenziellen Teilnehmenden nahmen an der ersten Runde der Delphi-Befragung 50 (46%) und an der zweiten Runde 39 Personen (36%) teil. In Runde eins gab es bei 24 von 33 Statements ein eindeutiges Ergebnis, 20 Statements wurde „zugestimmt“ und vier wurden „abgelehnt“. Neun Statements lagen zwischen 60 und 75% und wurden in Runde zwei den Teilnehmenden nochmals zur Bewertung vorgelegt. In der zweiten Runde wurde von diesen neun Statements vier Statements „zugestimmt“ und fünf Statements wurden „abgelehnt“. Als besonderer Fokus hat sich in dieser Delphi-Studie die „Digitale Gesundheitskompetenz“ herauskristallisiert.
Schlussfolgerung In der vorliegenden Delphi-Studie wurden unter Beteiligung von Experten und Expertinnen mögliche Themenschwerpunkte der Arbeitsgruppe Digital Health ausgewählt, priorisiert und zukünftige Entwicklungen von Digital Health im Kontext der Versorgungsforschung eingeschätzt. Die Ergebnisse spiegeln sowohl die Erwartungen und Interessen der Mitglieder*innen wieder, sind weitestgehend kohärent mit den Empfehlungen des Gutachtens „Digitalisierung für Gesundheit“ vom Sachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen.
... Bei der Evaluation von DI ergeben sich zahlreiche epistemologische und wissenschaftsethische Herausforderungen, die in die zentralen Betätigungsfelder der Versorgungsforschung fallen [1,2]. Auch neue Analysemethoden (z. ...
... Bei der Evaluation von DI ergeben sich zahlreiche epistemologische und wissenschaftsethische Herausforderungen, die in die zentralen Betätigungsfelder der Versorgungsforschung fallen [1,2]. Auch neue Analysemethoden (z. ...
Zusammenfassung
Methodische Herausforderungen bei der Evaluation digitaler Interventionen (DI) sind für die Versorgungsforschung allgegenwärtig. Die Arbeitsgruppe Digital Health des Deutschen Netzwerks Versorgungsforschung (DNVF) hat in einem zweiteiligen Diskussionspapier diese Herausforderungen dargestellt und diskutiert. Im ersten Teil wurden begriffliche Abgrenzungen sowie die Entwicklung und Evaluation von DI thematisiert. In diesem zweiten Teil wird auf Outcomes, das Reporting von Ergebnissen, die Synthese der Evidenz sowie die Implementierung von DI eingegangen. Lösungsansätze und zukünftige Forschungsbedarfe zur Adressierung dieser Herausforderungen werden diskutiert.
... Therefore, to be able to use digital care services meaningful and safe, professionals and patients in the healthcare system need a high level of eHL. This applies especially to the evaluation of health information on the Internet, but also to the evaluation of ICT [55]. Especially for non-professionals, digital care offers can be dangerous [56]. ...
The skills, knowledge and resources to search for, find, understand, evaluate and apply health information is defined as health literacy (HL). If individuals want to use health information from the Internet, they need Digital Health Literacy (eHL), which in addition to HL also includes,
for example, media literacy. If information cannot be found or understood by patients due to low (e)HL, patients will not have the opportunity to make informed decisions. In addition, many health apps for self-management or prevention also require (e)HL. Thus, it follows that active participation in healthcare, in terms of Person-Centered Care (PCC) is only possible through (e)HL. Currently, there is a great need to strengthen these competencies in society to achieve increased empowerment
of patients and their health. However, at the same time, there is a need to train and improve competencies in the field of healthcare professionals so that they can counsel and guide patients. This article provides an overview with a focus on HL and eHL in healthcare, shows the opportunities to adapt services and describes the possible handling of patients with low (e)HL. In addition, the opportunities for patients and healthcare professionals to improve (e)HL are highlighted.
... How does this translate to qualitative research under pandemic conditions? As in many other areas of society, one of the most widespread coping strategies in the health care sector is the use of digital technologies both by health care professionals and health care researchers, i.e., health services research [13,14]. Accordingly, there has also been a massive increase in "digital" data collection in health services research since spring 2020 [2,4,15,16]. ...
Background: The Covid-19 pandemic had a significant impact on professionals working in the medical area, resulting in a very high workload and tightened safety restrictions for physicians, nurses, caregivers, and patients. Medical professionals pose one of the main target groups in health services research. Their experiences contribute immensely to any research project aiming to improve delivery and quality of care. Furthermore, their input contributes significantly to gaining greater insight into the current handling of the pandemic and into what future improvements should be considered. In this paper, we discuss the challenges and benefits of conducting a qualitative research project under pandemic conditions by illustrating the progress of our research project ADAPTIVE.
Methods: ADAPTIVE started in March 2020 and ended in August 2021. For data collection, we asked 26 participants to take part in an interview about using a web-based program to facilitate the exchange of patient information in multidisciplinary teams. Unfortunately, due to emerging hygiene regulations, corona-related restrictions, and the ongoing workload of medical professionals, the recruiting and interviewing process was challenging. Because of that we had to modify the original study design.
Results: We discussed several adjustments for the data collection. However, the privacy policies of different clinics, professionals’ lack of experience with video calls, and participants’ poor internet connectivity eliminated the option of digital video interviewing. Alternatively, we interviewed participants by telephone. Nevertheless, telephone interviews come with limitations. Firstly, it may be difficult for participants to establish a trusting relationship with the interviewer. Secondly, non-verbal communication is lost during a telephone interview. Further, the focus group discussions initially planned had to be dismissed since a simultaneous gathering of the participants was not possible due several reasons.
Conclusions: Qualitative research offers greater flexibility when adapting study designs and can, therefore, be successful, even under pandemic conditions. However, recruitment and data collection showed to be more time-consuming than under non-pandemic circumstances, and some methodological instruments such as focus groups were not possible.
Trial registration: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00021603 (Registration: 02. July 2020)
... Humanmedizin mit Hinblick auf die Anforderungen an ein zunehmend digitales Gesundheitswesen der Zukunft übertragen lässt [27]. Die aktuellen Entwicklungen im Bereich der Gesundheitsund Medizin-Apps (GuMAs) sind ein Beispiel für einen potentiell großen Nutzen für die Patientenversorgung bei zeitgleicher Unklarheit über die Verlässlichkeit dieser Apps und damit die Auswirkung auf Patientensicherheit im Rahmen der Digitalisierung im Gesundheitswesen [28]. Ist eine App z. ...
Zusammenfassung
Hintergrund
Im Bereich der Ausbildung von Humanmedizinern wurden Themen der Digitalisierung des Gesundheitssystems bisher kaum adressiert, auch wenn seit 2015 im Nationalen Kompetenzbasierten Lernzielkatalog Medizin (NKLM) hierzu Kompetenzen als Lernziele definiert sind. Zeitgleich nimmt in der öffentlichen Wahrnehmung Telemedizin, als ein Bereich dieser Digitalisierung der einen ergänzenden Zugang zur medizinischen Versorgung bietet, einen zunehmend größeren Raum ein. Ziel war es, Medizinstudierenden im vierten vorklinischen Semester einen ersten Einblick in Telemedizin und weitere Aspekte der Digitalisierung im Gesundheitswesen im Rahmen eines Seminars zu vermitteln.
Methode
Auf der Basis der vorhandenen Literatur wurde ein inhaltlich-didaktisches Konzept für das Seminar „Die Arzt-Patienten-Beziehung im Spannungsfeld technischer Entwicklungen“ im Fach Medizinische Soziologie für Studierende der Humanmedizin der Universität zu Lübeck entwickelt. In Anlehnung an das vier Stufen Modell von Kirkpatrick wurden die Studierenden zu Beginn des Seminars zu Themenwünschen zum Thema Digitalisierung und Telemedizin und zum Abschluss des Seminars zu Einstellungen und Erfahrungen mit Telemedizin befragt.
Ergebnisse
Insgesamt besuchten 184 Studierende aus dem vierten vorklinischen Semester das Seminar. Die Rücklaufquote der Befragungen lag bei 32%. Die am häufigsten gewünschten Themen von Studierenden lauteten „Rechtliche Rahmenbedingungen“, „elektronische Patientenakte“ und „Fernsprechstunde“.
Das Thema Digitalisierung des Gesundheitswesens wurde von 85% der Studierenden als sehr relevant für ihren späteren Beruf eingeschätzt. Ebenfalls 85% der Studierenden wünschten sich eine einfache Bedienung von Geräten, die im Rahmen von Telemedizin eingesetzt werden. Eine größere Unsicherheit wurde von gut einem Drittel der Studierenden mit Bezug auf die Einschätzung des Nutzens von Gesundheits-Apps angegeben.
Schlussfolgerung
Die Inhalte des Seminars treffen auf eine große Nachfrage seitens der Studierenden. Zukünftig sollten Themen rund um die Digitalisierung des Gesundheitssystems vermehrt in der Ausbildung integriert werden. Die identifizierten Unsicherheiten der Studierenden bei der Einschätzung verschiedener telemedizinischer Anwendungen sollten zukünftig adressiert werden.
Purpose
To elaborate a concept for implementing digital health applications (DiHA), including prioritisation criteria (PC) for the Austrian context and an overview of available prioritised DiHAs.
Methods
Based on European DiHA-listings and input by Austrian experts, a categorised meta-directory of DiHAs was created. PC were developed to reflect, inter alia, the provisions of the Austrian General Insurance Act, and were applied to the meta-directory to identify DiHAs potentially relevant for the Austrian statutory health insurance. An iterative process with expert involvement was used to tailor an existing reimbursement framework to the Austrian setting.
Results
The meta-directory comprised 132 DiHAs. Developed PC focused on plausibility (German language) and legal aspects (treatment/monitoring of chronic conditions), while other criteria (e.g. interoperability standards) were considered optional. After applying the PC, 38 DiHAs were potentially relevant in the Austrian setting. Of these, only seven supported current health record integration. Most of the prioritised DiHAs reported on CE marking (29/38) and data protection (35/38), while reporting on risk class (10/38) and technical algorithms (0/38) was sparse. For DiHA reimbursement, a four-step process is proposed: identification (ideally based on needs assessment); filtering based on PC; review of technical, regulatory and evidentiary requirements; and health technology assessment.
Conclusion
The proposed concept can offer guidance for policy makers (e.g., on prioritising available DiHAs) and may further foster scientific debate with regard to DiHA implementation. Further discussion on how to fully incorporate regulatory, technical, and evidentiary criteria is needed. Attention should be given to national implementation requirements, re-assessment criteria, and appropriate remuneration schemes.
Zusammenfassung
Der Megatrend der Digitalisierung verändert viele Bereiche des täglichen Lebens. Er verändert auch das deutsche Gesundheitswesen, bringt vielfältige neue Leistungen und Gesundheitsangebote sowie Begrifflichkeiten mit sich, während gleichzeitig ein Handlungsbedarf zur Förderung der digitalen Gesundheitskompetenz der Bevölkerung besteht.
Diese Entwicklungen haben auch einen prägenden Einfluss auf den DVGS. Zur Qualitätssicherung und Professionalisierung und im Einklang mit den satzungsgemäßen Zielen wurde dieses Themenfeld fest in den Verbandsstrukturen verankert. In diesem Zusammenhang wird ein strukturiertes Vorgehen zur Planung, Steuerung und Evaluation der Digitalisierung des Verbands entwickelt (Digitalisierungsstrategie).
Der vorliegende Artikel gibt einen Überblick über wesentliche Maßnahmen dieser Digitalisierungsstrategie in Bezug auf die bedeutenden Tätigkeitsbereiche des DVGS wie das Lehrgangswesen, Betriebliche Gesundheitsförderung, Prävention, Gremienarbeit und die sport-/bewegungstherapeutische Versorgung. Weitere Digitalisierungsmaßnahmen (etwa in der Mitgliederverwaltung und im Mitgliederservice) sind ab dem kommenden Jahr geplant.
Digitale Interventionen (DI) zu gesundheitsbezogenen Themen gewinnen zunehmend an Bedeutung. Oftmals sind sie komplexe Interventionen, die in einem komplexen Versorgungskontext evaluiert und implementiert werden. Aufgrund der Merkmale digitaler Interventionen ist die Versorgungsforschung vor methodische Herausforderungen gestellt. Daher hat die Arbeitsgruppe Digital Health des Deutschen Netzwerks Versorgungsforschung (DNVF) ein Diskussionspapier erstellt. Darin wird diskutiert, welche Herausforderungen mit der Entwicklung und Evaluation von DI einhergehen. Es werden Lösungsansätze und zukünftige Forschungsbedarfe aufgezeigt.
The development and application of digital interventions in health-related topics are gaining momentum in health service research. Digital interventions are often complex and need to be evaluated and implemented in complex settings. Due to their characteristics, this poses methodological challenges for health services research that have to be identified and addressed. Hence, the Working Group on Digital Health of the German Network for Health Services Research (DNVF) has prepared a discussion paper. This paper discusses methodological, practical and theoretical challenges associated with the development and evaluation of digital interventions from the perspective of health services research. Possible solutions are suggested and future research needs to address these methodological challenges are identified.
Resilienz fördert die Bewältigung von belastenden Situationen am Arbeitsplatz und schützt dadurch die psychische Gesundheit von Beschäftigten. Zur Verdeutlichung von Ansatzpunkten der Resilienzförderung werden bestehende Konzeptualisierungen von Resilienz vorgestellt und in einem integrativen Modell von Resilienz im Arbeitskontext zusammengefasst. Auf Grundlage dieses Modells werden bestehende Interventionen zur Förderung von Resilienz vorgestellt und ausgewählte Beispiele von Interventionen näher erläutert. Abschließend werden Erfahrungen aus der Implementierung in der Praxis besprochen.
Zusammenfassung
Ziel der Studie Mit dem Digitale-Versorgung-Gesetz (DVG) können Ärzt/innen seit dem 19.12.2019 Digitale Gesundheitsanwendungen (DiGAs) verschreiben und Patient / innen haben Anspruch auf eine solche Versorgung. Nachfolgend soll geklärt werden, was niedergelassene Ärzt/ innen bei der Einbindung von DiGAs in die Versorgung berücksichtigen sollten und welche ethische Verantwortung ihnen dabei zukommt.
Methodik Mittels adaptierter prinzipienorientierter Fallanalyse werden drei fiktive, aber praxisnahe Kasuistiken beleuchtet. Das argumentativ-analytische Vorgehen basiert auf den vier medizinethischen Prinzipien Autonomie, Fürsorge, Nichtschaden und Gerechtigkeit nach Beauchamp und Childress sowie der Musterberufsordnung für die in Deutschland tätigen Ärztinnen und Ärzte (MBO-Ä).
Ergebnisse Bei der Verschreibung von DiGAs sollte das ärztliche Aufklärungsgespräch um die besonderen Risiken, die sich aus solchen Anwendungen ergeben, erweitert werden. Es ist insbesondere auf die digitale Gesundheitskompetenz von Patient/innen zu achten. Des Weiteren sollten DiGAs nicht den persönlichen Kontakt ersetzen, sondern allenfalls eine Ergänzung und Unterstützung leitliniengerechter Behandlung bieten. Um Patient/innen zu einem selbstständigeren Gebrauch zu befähigen, wird eine ‚Applikationsanamnese‘ empfohlen.
Schlussfolgerung Die Prinzipienethik nach Beauchamp und Childress sowie die MBO-Ä sind auch für den Umgang mit DiGAs in der Patientenversorgung instruktiv. Die vorgestellten Dos und Don’ts sollten kontinuierlich um weitere Leitplanken ergänzt werden, die Ärzt / innen Orientierung bieten, wie sie DiGAs verantwortlich in der Patientenversorgung einbinden können.
In Cicely Saunders' "high-person, low-technology"-Ansatz von 1977 wird die Lebensqualität von Palliativpatient*innen durch die Fokussierung auf das Menschliche gesteigert. Der Artikel betrachtet diese Aussage von Shephard (1977) in Bezug auf die heutige Palliativversorgung mit der Perspektive "high-self-efficacy, smart-technology". Dies soll aufzeigen, wie Technologie und Selbstwirksamkeit gemeinsam die Palliativversorgung verbessern können.
Mobile health apps (MHAs) and medical apps (MAs) are becoming increasingly popular as digital interventions in a wide range of health-related applications in almost all sectors of healthcare. The surge in demand for digital medical solutions has been accelerated by the need for new diagnostic and therapeutic methods in the current coronavirus disease 2019 pandemic. This also applies to clinical practice in gastroenterology, which has, in many respects, undergone a recent digital transformation with numerous consequences that will impact patients and health care professionals in the near future. MHAs and MAs are considered to have great potential, especially for chronic diseases, as they can support the self-management of patients in many ways. Despite the great potential associated with the application of MHAs and MAs in gastroenterology and health care in general, there are numerous challenges to be met in the future, including both the ethical and legal aspects of applying this technology. The aim of this article is to provide an overview of the current status of MHA and MA use in the field of gastroenterology, describe the future perspectives in this field and point out some of the challenges that need to be addressed.
Zusammenfassung
Digitale Technologien sind in nahezu alle Lebensbereiche diffundiert und somit zu einem ständigen Begleiter unseres Alltags geworden. Digitalen Interventionen werden auch Potenziale in der Prävention und Gesundheitsförderung zugeschrieben. Bislang mangelt es aber an fundierten Belegen zur Wirksamkeit entsprechender Maßnahmen. In diesem Beitrag sollen die Herausforderungen der Evidenzbasierung von digitalen Interventionen in der Prävention und Gesundheitsförderung aufgezeigt werden. Die Ergebnisse werden in Form eines narrativen Übersichtsbeitrags zusammengefasst.
Bislang wurden Methoden der evidenzbasierten Medizin bei der Bewertung des Nutzens und Schadens im Bereich von Prävention und Gesundheitsförderung nicht oder nur bedingt eingesetzt. Gründe dafür liegen in der Komplexität entsprechender Maßnahmen. Diese Komplexität wird bei digitalen Interventionen nochmals erhöht. Dennoch wird dringend angeraten, einen stärkeren Fokus auf die Evidenzbasierung zu legen, um aussagekräftige und nachvollziehbare Bewertungsverfahren hinsichtlich der Wirksamkeit digitaler Interventionen in Prävention und Gesundheitsförderung zu ermöglichen.
Die Digitalisierung führt zu neuen Anforderungen an Prävention und Gesundheitsförderung. Es bedarf einer kritischen Perspektive auf die tatsächlichen Wirkpotenziale digitaler Interventionen sowie deren gesellschaftliche Implikationen. Der Aufbau einer soliden Wissensbasis ist notwendig, um Akzeptanz gegenüber den Technologien zu fördern und eine nachhaltige Etablierung zu erreichen.
Commercial mobile apps for health behavior change are flourishing in the marketplace, but little evidence exists to support their use. This paper summarizes methods for evaluating the content, usability, and efficacy of commercially available health apps. Content analyses can be used to compare app features with clinical guidelines, evidence-based protocols, and behavior change techniques. Usability testing can establish how well an app functions and serves its intended purpose for a target population. Observational studies can explore the association between use and clinical and behavioral outcomes. Finally, efficacy testing can establish whether a commercial app impacts an outcome of interest via a variety of study designs, including randomized trials, multiphase optimization studies, and N-of-1 studies. Evidence in all these forms would increase adoption of commercial apps in clinical practice, inform the development of the next generation of apps, and ultimately increase the impact of commercial apps.
Background
In March 2015, Apple Inc announced ResearchKit, a novel open-source framework intended to help medical researchers to easily create apps for medical studies. With the announcement of this framework, Apple presented 5 apps built in a beta phase based on this framework.
Objective
The objective of this study was to better understand decision making in patients with acute anterior cruciate ligament (ACL) ruptures. Here, we describe the development of a ResearchKit app for this study.
Methods
A multilanguage observatory study was conducted. At first a suitable research topic, target groups, participating territories, and programming method were carefully identified. The ResearchKit framework was used to program the app. A secure server connection was realized via Secure Sockets Layer. A data storage and security concept separating personal information and study data was proposed. Furthermore, an efficient method to allow multilanguage support and distribute the app in many territories was presented. Ethical implications were considered and taken into account regarding privacy policies.
Results
An app study based on ResearchKit was developed without comprehensive iPhone Operating System (iOS) development experience. The Apple App Store is a major distribution channel causing significant download rates (>1.200/y) without active recruitment. Preliminary data analysis showed moderate dropout rates and a good quality of data. A total of 180 participants were currently enrolled with 107 actively participating and producing 424 completed surveys in 9 out of 24 months.
Conclusions
ResearchKit is an easy-to-use framework and powerful tool to create medical studies. Advantages are the modular built, the extensive reach of iOS devices, and the convenient programming environment.
Background
Today, runners use wearable technology such as global positioning system (GPS)–enabled sport watches to track and optimize their training activities, for example, when participating in a road race event. For this purpose, an increasing amount of low-priced, consumer-oriented wearable devices are available. However, the variety of such devices is overwhelming. It is unclear which devices are used by active, healthy citizens and whether they can provide accurate tracking results in a diverse study population. No published literature has yet assessed the dissemination of wearable technology in such a cohort and related influencing factors.
Objective
The aim of this study was 2-fold: (1) to determine the adoption of wearable technology by runners, especially “smart” devices and (2) to investigate on the accuracy of tracked distances as recorded by such devices.
MethodsA pre-race survey was applied to assess which wearable technology was predominantly used by runners of different age, sex, and fitness level. A post-race survey was conducted to determine the accuracy of the devices that tracked the running course. Logistic regression analysis was used to investigate whether age, sex, fitness level, or track distance were influencing factors. Recorded distances of different device categories were tested with a 2-sample t test against each other.
ResultsA total of 898 pre-race and 262 post-race surveys were completed. Most of the participants (approximately 75%) used wearable technology for training optimization and distance recording. Females (P=.02) and runners in higher age groups (50-59 years: P=.03; 60-69 years: P
Background:
Mobile health solutions have the potential of reducing burdens on health systems and empowering patients with important information. However, there is a lack of theory-based mHealth interventions.
Objective:
The purpose of our study was to develop a participative, theory-based, mobile phone, audio messaging intervention attractive to recently circumcised men at voluntary medical male circumcision (VMMC) clinics in the Cape Town area in South Africa. We aimed to shift some of the tasks related to postoperative counselling on wound management and goal setting on safe sex. We place an emphasis on describing the full method of message generation to allow for replication.
Methods:
We developed an mHealth intervention using a staggered qualitative methodology: (1) focus group discussions with 52 recently circumcised men and their partners to develop initial voice messages they felt were relevant and appropriate, (2) thematic analysis and expert consultation to select the final messages for pilot testing, and (3) cognitive interviews with 12 recent VMMC patients to judge message comprehension and rank the messages. Message content and phasing were guided by the theory of planned behavior and the health action process approach.
Results:
Patients and their partners came up with 245 messages they thought would help men during the wound-healing period. Thematic analysis revealed 42 different themes. Expert review and cognitive interviews with more patients resulted in 42 messages with a clear division in terms of needs and expectations between the initial wound-healing recovery phase (weeks 1-3) and the adjustment phase (weeks 4-6). Discussions with patients also revealed potential barriers to voice messaging, such as lack of technical knowledge of mobile phones and concerns about the invasive nature of the intervention. Patients' own suggested messages confirmed Ajzen's theory of planned behavior that if a health promotion intervention can build trust and be relevant to the recipient's needs in the first contacts, then the same recipients will perceive subsequent motivational messages more favorably. The health action process approach was also a useful tool for guiding the phasing of the messages. Participants were more positive and salutogenic than public health experts.
Conclusions:
The system showed how a process of consultation can work with a set of potential recipients of an mHealth service to ensure that their needs are included. Classic behavioral theories can and should be used to design modern mHealth interventions. We also believe that patients are the best source of messaging, ensuring that messages are culturally relevant and interesting to the recipient.
Background:
The Mobile Application Rating Scale (MARS) provides a reliable method to assess the quality of mobile health (mHealth) apps. However, training and expertise in mHealth and the relevant health field is required to administer it.
Objective:
This study describes the development and reliability testing of an end-user version of the MARS (uMARS).
Methods:
The MARS was simplified and piloted with 13 young people to create the uMARS. The internal consistency and test-retest reliability of the uMARS was then examined in a second sample of 164 young people participating in a randomized controlled trial of a mHealth app. App ratings were collected using the uMARS at 1-, 3,- and 6-month follow up.
Results:
The uMARS had excellent internal consistency (alpha = .90), with high individual alphas for all subscales. The total score and subscales had good test-retest reliability over both 1-2 months and 3 months.
Conclusions:
The uMARS is a simple tool that can be reliably used by end-users to assess the quality of mHealth apps.
Background:
Continuous glucose monitoring (CGM) patient systems have been shown to improve diabetes self-treatment when used consistently. The meaningful integration of this technology into everyday life, however, can vary greatly among CGM users and not all people with diabetes use CGM to its full potential. To address this issue, the study pursued 2 aims: first, to identify patient characteristics that underlie the acceptance of CGM in people with type 1 diabetes and, second, to examine the effects of different levels of experience with CGM use.
Methods:
Guided by a model based on the technology acceptance model (TAM), structural equation modeling (SEM) was employed to model the patient characteristics as predictors of CGM acceptance. In all, 111 participants (60.4% female, mean = 37.6 years, SD = 11.2) participated in a web-based survey; 40 were current CGM users, 18 were former users and 53 had no experience with CGM systems.
Results:
In general, participants evaluated CGM positively; however, the feeling of information overload represented a major barrier to the sustained use of CGM, while perceptions of usefulness and ease of use constituted incentives for using this technology. Moreover, patients without CGM experience imagined more information overload than current users reported. Current users showed more intention to use CGM than former users.
Conclusion:
This study highlights the importance of CGM user experience for the effective use of this technology.
The accuracy and precision of the Instant Blood Pressure app are evaluated amid concerns that individuals may use these apps to assess their blood pressure and titrate therapy.Mobile health (mHealth) technologies include unregulated consumer smartphone apps.1 The Instant Blood Pressure app (IBP; AuraLife) estimates blood pressure (BP) using a technique in which the top edge of the smartphone is placed on the left side of the chest while the individual places his or her right index finger over the smartphone’s camera. Between its release on June 5, 2014, and removal on July 30, 2015 (421 days), the IBP app spent 156 days as one of the top 50 best-selling iPhone apps; at least 950 copies of this $4.99 app were sold on each of those days.2 Validation of this popular app or any of the similar iPhone apps still available (eg, Blood Pressure Pocket, Quick Blood Pressure Measure and Monitor), have not been performed. Using a protocol based on national guidelines,3 we investigated the accuracy and precision of IBP.
Background:
Activity trackers can potentially stimulate users to increase their physical activity behavior. The aim of this study was to examine the reliability and validity of ten consumer activity trackers for measuring step count in both laboratory and free-living conditions.
Method:
Healthy adult volunteers (n = 33) walked twice on a treadmill (4.8 km/h) for 30 min while wearing ten different activity trackers (i.e. Lumoback, Fitbit Flex, Jawbone Up, Nike+ Fuelband SE, Misfit Shine, Withings Pulse, Fitbit Zip, Omron HJ-203, Yamax Digiwalker SW-200 and Moves mobile application). In free-living conditions, 56 volunteers wore the same activity trackers for one working day. Test-retest reliability was analyzed with the Intraclass Correlation Coefficient (ICC). Validity was evaluated by comparing each tracker with the gold standard (Optogait system for laboratory and ActivPAL for free-living conditions), using paired samples t-tests, mean absolute percentage errors, correlations and Bland-Altman plots.
Results:
Test-retest analysis revealed high reliability for most trackers except for the Omron (ICC .14), Moves app (ICC .37) and Nike+ Fuelband (ICC .53). The mean absolute percentage errors of the trackers in laboratory and free-living conditions respectively, were: Lumoback (-0.2, -0.4), Fibit Flex (-5.7, 3.7), Jawbone Up (-1.0, 1.4), Nike+ Fuelband (-18, -24), Misfit Shine (0.2, 1.1), Withings Pulse (-0.5, -7.9), Fitbit Zip (-0.3, 1.2), Omron (2.5, -0.4), Digiwalker (-1.2, -5.9), and Moves app (9.6, -37.6). Bland-Altman plots demonstrated that the limits of agreement varied from 46 steps (Fitbit Zip) to 2422 steps (Nike+ Fuelband) in the laboratory condition, and 866 steps (Fitbit Zip) to 5150 steps (Moves app) in the free-living condition.
Conclusion:
The reliability and validity of most trackers for measuring step count is good. The Fitbit Zip is the most valid whereas the reliability and validity of the Nike+ Fuelband is low.
Low physical activity level is a significant contributor to chronic disease, weight dysregulation, and mortality. Nearly 70% of the American population is overweight, and 35% is obese. Obesity costs an estimated US$ 147 billion annually in health care, and as many as 95 million years of life. Although poor nutritional habits remain the major culprit, lack of physical activity significantly contributes to the obesity epidemic and related lifestyle diseases.
Over the past 10 years, mobile devices have become ubiquitous, and there is an ever-increasing number of mobile apps that are being developed to facilitate physical activity, particularly for active people. However, no systematic assessment has been performed about their quality with respect to following the parameters of sound fitness principles and scientific evidence, or suitability for a variety of fitness levels. The aim of this paper is to fill this gap and assess the quality of mobile coaching apps on iOS mobile devices.
A set of 30 popular mobile apps pertaining to physical activity programming was identified and reviewed on an iPhone device. These apps met the inclusion criteria and provided specific prescriptive fitness and exercise programming content. The content of these apps was compared against the current guidelines and fitness principles established by the American College of Sports Medicine (ACSM). A weighted scoring method based on the recommendations of the ACSM was developed to generate subscores for quality of programming content for aerobic (0-6 scale), resistance (0-6 scale), and flexibility (0-2 scale) components using the frequency, intensity, time, and type (FITT) principle. An overall score (0-14 scale) was generated from the subscores to represent the overall quality of a fitness coaching app.
Only 3 apps scored above 50% on the aerobic component (mean 0.7514, SD 1.2150, maximum 4.1636), 4 scored above 50% on the resistance/strength component (mean 1.4525, SD 1.2101, maximum 4.1094), and no app scored above 50% on the flexibility component (mean 0.1118, SD 0.2679, maximum 0.9816). Finally, only 1 app had an overall score (64.3%) above 50% (mean 2.3158, SD 1.911, maximum 9.0072).
There are over 100,000 health-related apps. When looking at popular free apps related to physical activity, we observe that very few of them are evidence based, and respect the guidelines for aerobic activity, strength/resistance training, and flexibility, set forth by the ACSM. Users should exercise caution when adopting a new app for physical activity purposes. This study also clearly identifies a gap in evidence-based apps that can be used safely and effectively to start a physical routine program, develop fitness, and lose weight. App developers have an exciting opportunity to improve mobile coaching app quality by addressing these gaps.
Background
With increasing age, prevention and health promotion are becoming more important, because of age-related decline of physical and mental skills. Technically supported self-monitoring can help maintain the health of older adults. The technologies often address particularly younger target groups and thus are often not suitable for older adults.
Objectives
In the presented study we will show how older adults use a smartphone application (app) for self-monitoring. Both user behavior and usability were analyzed to derive universally valid recommendations and requirements.
Materials and methods
In the following study 30 older adults without smartphone experience were included. After extensive training, the participants used the app MyTherapy for 4 weeks. Along with predicted usage, user behavior and usability of the app were recorded in a standardized manner.
Results
More than 80 % of the older participants used the app on a daily basis. Although the users rarely reported having problems when using the app, usability was rated moderately.
Discussion
To ensure extensive use of technologies for self-monitoring, a senior-friendly training concept and a technical support system must be provided. Further studies addressing long-term motivation with a larger sample in more diverse populations should be conducted.
To determine the diagnostic and triage accuracy of online symptom checkers (tools that use computer algorithms to help patients with self diagnosis or self triage).
Audit study.
Publicly available, free symptom checkers.
23 symptom checkers that were in English and provided advice across a range of conditions. 45 standardized patient vignettes were compiled and equally divided into three categories of triage urgency: emergent care required (for example, pulmonary embolism), non-emergent care reasonable (for example, otitis media), and self care reasonable (for example, viral upper respiratory tract infection).
For symptom checkers that provided a diagnosis, our main outcomes were whether the symptom checker listed the correct diagnosis first or within the first 20 potential diagnoses (n=770 standardized patient evaluations). For symptom checkers that provided a triage recommendation, our main outcomes were whether the symptom checker correctly recommended emergent care, non-emergent care, or self care (n=532 standardized patient evaluations).
The 23 symptom checkers provided the correct diagnosis first in 34% (95% confidence interval 31% to 37%) of standardized patient evaluations, listed the correct diagnosis within the top 20 diagnoses given in 58% (55% to 62%) of standardized patient evaluations, and provided the appropriate triage advice in 57% (52% to 61%) of standardized patient evaluations. Triage performance varied by urgency of condition, with appropriate triage advice provided in 80% (95% confidence interval 75% to 86%) of emergent cases, 55% (47% to 63%) of non-emergent cases, and 33% (26% to 40%) of self care cases (P<0.001). Performance on appropriate triage advice across the 23 individual symptom checkers ranged from 33% (95% confidence interval 19% to 48%) to 78% (64% to 91%) of standardized patient evaluations.
Symptom checkers had deficits in both triage and diagnosis. Triage advice from symptom checkers is generally risk averse, encouraging users to seek care for conditions where self care is reasonable.
© Semigran et al 2015.
The use of mobile apps for health and well being promotion has grown exponentially in recent years. Yet, there is currently no app-quality assessment tool beyond "star"-ratings.
The objective of this study was to develop a reliable, multidimensional measure for trialling, classifying, and rating the quality of mobile health apps.
A literature search was conducted to identify articles containing explicit Web or app quality rating criteria published between January 2000 and January 2013. Existing criteria for the assessment of app quality were categorized by an expert panel to develop the new Mobile App Rating Scale (MARS) subscales, items, descriptors, and anchors. There were sixty well being apps that were randomly selected using an iTunes search for MARS rating. There were ten that were used to pilot the rating procedure, and the remaining 50 provided data on interrater reliability.
There were 372 explicit criteria for assessing Web or app quality that were extracted from 25 published papers, conference proceedings, and Internet resources. There were five broad categories of criteria that were identified including four objective quality scales: engagement, functionality, aesthetics, and information quality; and one subjective quality scale; which were refined into the 23-item MARS. The MARS demonstrated excellent internal consistency (alpha = .90) and interrater reliability intraclass correlation coefficient (ICC = .79).
The MARS is a simple, objective, and reliable tool for classifying and assessing the quality of mobile health apps. It can also be used to provide a checklist for the design and development of new high quality health apps.
Background: Mobile apps for people with diabetes offer great potential to support therapy management, increase therapy adherence, and reduce the probability of the occurrence of accompanying and secondary diseases. However, they are rarely used by elderly patients due to a lack of acceptance.
Objective: We investigated the question “Which factors influence the acceptance of diabetes apps among patients aged 50 or older?” Particular emphasis was placed on the current use of mobile devices/apps, acceptance-promoting/-inhibiting factors, features of a helpful diabetes app, and contact persons for technical questions. This qualitative study was the third of three substudies investigating factors influencing acceptance of diabetes apps among patients aged 50 or older.
Methods: Guided interviews were chosen in order to get a comprehensive insight into the subjective perspective of elderly diabetes patients. At the end of each interview, the patients tested two existing diabetes apps to reveal obstacles in (first) use.
Results: Altogether, 32 patients with diabetes were interviewed. The mean age was 68.8 years (SD 8.2). Of 32 participants, 15 (47%) knew apps, however only 2 (6%) had already used a diabetes app within their therapy. The reasons reported for being against the use of apps were a lack of additional benefits (4/8, 50%) compared to current therapy management, a lack of interoperability with other devices/apps (1/8, 12%), and no joy of use (1/8, 12%). The app test revealed the following main difficulties in use: nonintuitive understanding of the functionality of the apps (26/29, 90%), nonintuitive understanding of the menu navigation/labeling (19/29, 66%), font sizes and representations that were too small (14/29, 48%), and difficulties in recognizing and pressing touch-sensitive areas (14/29, 48%). Furthermore, the patients felt the apps lacked individually important functions (11/29, 38%), or felt the functions that were offered were unnecessary for their own therapy needs (10/29, 34%). The most important contents of a helpful diabetes app were reported as the ability to add remarks to measured values (9/28, 32%), the definition of thresholds for blood glucose values and highlighting deviating values (7/28, 25%), and a reminder feature for measurement/medication (7/28, 25%). The most important contact persons for technical questions were family members (19/31, 61%).
Conclusions: A lack of additional benefits and ease of use emerged as the key factors for the acceptance of diabetes apps among patients aged 50 or older. Furthermore, it has been shown that the needs of the investigated target group are highly heterogeneous due to varying previous knowledge, age, type of diabetes, and therapy. Therefore, a helpful diabetes app should be individually adaptable. Personal contact persons, especially during the initial phase of use, are of utmost importance to reduce the fear of data loss or erroneous data input, and to raise acceptance among this target group.
Background:
Despite their increasing popularity, little is known about how users perceive mobile devices such as smartphones and tablet PCs in medical contexts. Available studies are often restricted to evaluating the success of specific interventions and do not adequately cover the users' basic attitudes, for example, their expectations or concerns toward using mobile devices in medical settings.
Objective:
The objective of the study was to obtain a comprehensive picture, both from the perspective of the patients, as well as the doctors, regarding the use and acceptance of mobile devices within medical contexts in general well as the perceived challenges when introducing the technology.
Methods:
Doctors working at Hannover Medical School (206/1151, response 17.90%), as well as patients being admitted to this facility (213/279, utilization 76.3%) were surveyed about their acceptance and use of mobile devices in medical settings. Regarding demographics, both samples were representative of the respective study population. GNU R (version 3.1.1) was used for statistical testing. Fisher's exact test, two-sided, alpha=.05 with Monte Carlo approximation, 2000 replicates, was applied to determine dependencies between two variables.
Results:
The majority of participants already own mobile devices (doctors, 168/206, 81.6%; patients, 110/213, 51.6%). For doctors, use in a professional context does not depend on age (P=.66), professional experience (P=.80), or function (P=.34); gender was a factor (P=.009), and use was more common among male (61/135, 45.2%) than female doctors (17/67, 25%). A correlation between use of mobile devices and age (P=.001) as well as education (P=.002) was seen for patients. Minor differences regarding how mobile devices are perceived in sensitive medical contexts mostly relate to data security, patients are more critical of the devices being used for storing and processing patient data; every fifth patient opposed this, but nevertheless, 4.8% of doctors (10/206) use their devices for this purpose. Both groups voiced only minor concerns about the credibility of the provided content or the technical reliability of the devices. While 8.3% of the doctors (17/206) avoided use during patient contact because they thought patients might be unfamiliar with the devices, (25/213) 11.7% of patients expressed concerns about the technology being too complicated to be used in a health context.
Conclusions:
Differences in how patients and doctors perceive the use of mobile devices can be attributed to age and level of education; these factors are often mentioned as contributors of the problems with (mobile) technologies. To fully realize the potential of mobile technologies in a health care context, the needs of both the elderly as well as those who are educationally disadvantaged need to be carefully addressed in all strategies relating to mobile technology in a health context.
Background
Mobile health (mHealth) has undergone exponential growth in recent years. Patients and healthcare professionals are increasingly using health-related applications, at the same time as concerns about ethical issues, bias, conflicts of interest and privacy are emerging. The general aim of this paper is to provide an overview of the current state of development of mHealth.
Methods and Findings
To exemplify the issues, we made a systematic review of the pain-related apps available in scientific databases (Medline, Web of Science, Gale, Psycinfo, etc.) and the main application shops (App Store, Blackberry App World, Google Play, Nokia Store and Windows Phone Store). Only applications (designed for both patients and clinicians) focused on pain education, assessment and treatment were included. Of the 47 papers published on 34 apps in scientific databases, none were available in the app shops. A total of 283 pain-related apps were found in the five shops searched, but no articles have been published on these apps. The main limitation of this review is that we did not look at all stores in all countries.
Conclusions
There is a huge gap between the scientific and commercial faces of mHealth. Specific efforts are needed to facilitate knowledge translation and regulate commercial health-related apps.
Interest in smartphone health apps has been increasing recently. However, we have little understanding of the cognitive and motivational factors that influence the extent of health-app use.
This study aimed to examine the effects of four cognitive factors-health consciousness, health information orientation, eHealth literacy, and health-app use efficacy-on the extent of health-app use. It also explored the influence of two different use patterns-information and information-behavior use of health apps-with regard to the relationships among the main study variables.
We collected and analyzed 765 surveys in South Korea. According to the results, there was a negligible gender difference: males (50.6%, 387/765) and females (49.4%, 378/765). All participants were adults whose ages ranged from 19 to 59. In order to test the proposed hypotheses, we used a path analysis as a specific form of structural equation modeling.
Through a path analysis, we discovered that individuals' health consciousness had a direct effect on their use of health apps. However, unlike the initial expectations, the effects of health information orientation and eHealth literacy on health-app use were mediated by health-app use efficacy.
The results from the path analysis addressed a significant direct effect of health consciousness as well as strong mediating effects of health-app use efficacy. These findings contribute to widening our comprehension of the new, digital dimensions of health management, particularly those revolving around mobile technology.
The rapidly increasing number of patients with implantable cardioverter-defibrillators (ICD) places a large burden on follow-up providers. This study investigated the possibility of longer in-office follow-up intervals in primary prevention ICD patients under remote monitoring with automatic daily data transmissions from the implant memory.
Conducted in 155 ICD recipients with MADIT II indications, the study compared the burden of scheduled and unscheduled ICD follow-up visits, quality of life (SF-36), and clinical outcomes in patients randomized to either 3- or 12-month follow-up intervals in the period between 3 and 27 months after implantation. Remote monitoring (Biotronik Home Monitoring) was used equally in all patients. In contrast to previous clinical studies, no calendar-based remote data checks were performed between scheduled in-office visits. Compared with the 3-month follow-up interval, the 12-month interval resulted in a minor increase in the number of unscheduled follow-ups (0.64 vs. 0.27 per patient-year; P = 0.03) and in a major reduction in the total number of in-office ICD follow-ups (1.60 vs. 3.85 per patient-year; P < 0.001). No significant difference was found in mortality, hospitalization rate, or hospitalization length during the 2-year observation period, but more patients were lost to follow-up in the 12-month group (10 vs. 3; P = 0.04). The SF-36 scores favoured the 12-month intervals in the domains 'social functioning' and 'mental health'.
In prophylactic ICD recipients under automatic daily remote monitoring, the extension of the 3-month in-office follow-up interval to 12 months appeared to safely reduce the ICD follow-up burden during 27 months after implantation.
NCT00401466 (http://www.clinicaltrials.gov/ct2/show/NCT00401466).
Professional practice guidelines recommend that pacemaker recipients be followed regularly. However, the majority of scheduled ambulatory visits is unproductive and imposes a heavy burden on the health-care system.
The COMPAS randomized, multicentre, non-inferiority trial examined the safety of long-term remote monitoring of pacemakers. Between December 2005 and January 2008, 538 patients were randomly assigned to remote monitoring follow-up (active group) vs. standard care (control group). The primary objective was to confirm that the proportion of patients who experienced at least one major adverse event (MAE), including all-cause death and hospitalizations for device-related or cardiovascular adverse events, was not >7% higher in the active than in the control group. MAE-free survivals and quality of life were compared in both groups. The characteristics of the study groups were similar. Over a follow-up of 18.3 months, 17.3% of patients in the active and 19.1% in the control group experienced at least one MAE (P < 0.01 for non-inferiority). Hospitalizations for atrial arrhythmias (6 vs. 18) and strokes (2 vs. 8) were fewer (P < 0.05), and the number of interim ambulatory visits was 56% lower (P < 0.001) in the active than the control group. Changes in pacemaker programming or drug regimens were made in 62% of visits in the active vs. 29% in the control group (P < 0.001). Quality of life remained unchanged in both groups.
Remote monitoring was a safe alternative to conventional care and significantly lowered the number of ambulatory visits during long-term follow-up of permanently paced patients. ClinicalTrials.gov identifier: NCT00989326.
Handheld computers are increasingly favoured over paper and pencil methods to capture data in clinical research.
This study systematically identified and reviewed randomized controlled trials (RCTs) that compared the two methods for self-recording and reporting data, and where at least one of the following outcomes was assessed: data accuracy; timeliness of data capture; and adherence to protocols for data collection.
A comprehensive key word search of NLM Gateway's database yielded 9 studies fitting the criteria for inclusion. Data extraction was performed and checked by two of the authors. None of the studies included all outcomes. The results overall, favor handheld computers over paper and pencil for data collection among study participants but the data are not uniform for the different outcomes. Handheld computers appear superior in timeliness of receipt and data handling (four of four studies) and are preferred by most subjects (three of four studies). On the other hand, only one of the trials adequately compared adherence to instructions for recording and submission of data (handheld computers were superior), and comparisons of accuracy were inconsistent between five studies.
Handhelds are an effective alternative to paper and pencil modes of data collection; they are faster and were preferred by most users.
In the early 1890s, Dr William Halsted developed radical mastectomy for breast cancer. Surgeons performed the Halsted procedure for more than 80 years even though there was little systematic evidence for its success. Then a new breed of scholars subjected the procedure to formal methods of evaluation unknown to Halsted.1 The methods—randomized controlled trials (RCTs) principal among them—led to a surprise: radical mastectomy had no advantage over simpler forms of treatment.2
Background
Internet-based self-management interventions are effective in the prevention and treatment of mental disorders; however, for those affected as well as treating clinicians and decision makers in the healthcare sector, it is difficult to identify safe and effective interventions.
Aim
Development of quality criteria for self-management interventions.
Methods
Based on a non-specific assessment matrix, a task force from two scientific societies formulated specific quality criteria for self-management interventions for mental disorders. Patients and other relevant stakeholders were involved in the process.
Results
A total of 8 key criteria with 17 subordinate points were developed. These must be met for the certification of an intervention. The criteria focus on therapeutic quality requirements, patient safety, data protection and security as well as proof of efficacy in at least one randomized study. A further five criteria are only descriptive and are not required for certification.
Discussion
These quality criteria serve as a starting point for the establishment of a certification process. This could help to make internet-based self-management interventions for mental disorders part of routine care in the German healthcare system.
The term "digital health" is currently the most comprehensive term that includes all information and communication technologies in healthcare, including e-health, mobile health, telemedicine, big data, health apps and others. Digital health can be seen as a good example of the use of the concept and methodology of health services research in the interaction between complex interventions and complex contexts. The position paper deals with 1) digital health as the subject of health services research; 2) digital health as a methodological and ethical challenge for health services research. The often-postulated benefits of digital health interventions should be demonstrated with good studies. First systematic evaluations of apps for "treatment support" show that risks are higher than benefits. The need for a rigorous proof applies even more to big data-assisted interventions that support decision-making in the treatment process with the support of artificial intelligence. Of course, from the point of view of health services research, it is worth participating as much as possible in data access available through digital health and "big data". However, there is the risk that a noncritical application of digital health and big data will lead to a return to a linear understanding of biomedical research, which, at best, accepts complex conditions assuming multivariate models but does not take complex facts into account. It is not just a matter of scientific ethical requirements in health services care research, for instance, better research instead of unnecessary research ("reducing waste"), but it is primarily a matter of anticipating the social consequences (system level) of scientific analysis and evaluation. This is both a challenge and an attractive option for health services research to present itself as a mature and responsible scientific discipline.
© Georg Thieme Verlag KG Stuttgart · New York.
Zusammenfassung
Gesundheits-Apps haben in wenigen Jahren weite Teile der Bevölkerung erreicht. Ob sich mit diesen Apps die erwarteten Gesundheitsziele besser erreichen lassen und ob die Gesundheitsinformationen oder Handlungsempfehlungen der Apps unabhängig, korrekt, aktuell und damit vertrauenswürdig sind, lässt sich nicht nur für Verbraucher und Patienten, sondern auch für Ärzte, Therapeuten und Pflegekräfte, d. h. Health Care Professionals (HCP), aufgrund lückenhafter Aufklärung durch die App-Anbieter schwer einschätzen. Von staatlicher Seite ist für fast alle Apps vor Veröffentlichung in den Stores weder in Deutschland noch in den USA eine Qualitätsüberprüfung vorgesehen. Experten aus Politik und Wissenschaft fordern zum Schutz von Verbrauchern verbindliche Kriterien, die eine Qualitätseinschätzung der nicht regulierten Gesundheits-Apps erlauben. Führt man die Qualität einer App primär auf ihren Nutzen und ihre Unbedenklichkeit für den Verbraucher zurück, rücken Aspekte wie Zielgruppenerreichbarkeit und Zielgruppenorientierung einer App als qualitätsbestimmende Faktoren in den Vordergrund. Nur wenige Apps erreichen relevante Nutzergruppen und werden nachhaltig genutzt. Unter dem Aspekt der Patientensicherheit sind große Unterschiede im Nutzungsrisiko einer Gesundheits-App erkennbar. In diesem Kontext wird die 4-stufige Risikoklassifizierung vorgestellt, die auf der Grundlage der Analyse von über 6000 Gesundheits-Apps empirisch entwickelt wurde. Außerdem wird am Beispiel der Qualitäts- und Transparenzkriterien des HealthOn-Ehrenkodex gezeigt, wie sich Gesundheits-Apps einschätzen lassen im Hinblick auf folgende Aspekte: Individuelles Nutzungsrisiko für ihren Anwender, Sachverständigkeit des Unterstützungsansatzes, Unabhängigkeit der gesundheitsbezogenen Inhalte, Schutz der mit der App erfassten persönlichen Nutzungs- und Gesundheitsdaten, Möglichkeit des Nutzers im Haftungsfall Verbraucherrechte durchsetzen zu können.
Symptoms are common among patients receiving treatment for advanced cancers,¹ yet are undetected by clinicians up to half the time.² There is growing interest in integrating electronic patient-reported outcomes (PROs) into routine oncology practice for symptom monitoring, but evidence demonstrating clinical benefit has been limited.
Zusammenfassung
Hintergrund
Der in Deutschland bislang zögerliche Übergang telemedizinisch unterstützter Versorgungsansätze in die Regelversorgung kann unter anderem auf Defizite in der Evaluationspraxis dieser Anwendungen zurückgeführt werden. Ohne methodisch solide und vollständig publizierte Evaluationen können die notwendigen Wirksamkeits- bzw. Kosteneffektivitätsnachweise für Entscheidungsträger und potenzielle Anwender nicht erbracht werden. Für adäquate, vergleichbare Evaluationen telemedizinischer Anwendungen fehlen wissenschaftlich fundierte und verbindliche methodische Standards.
Methoden
Im Rahmen des telemedizinischen Infrastrukturprojektes CCS Telehealth Ostsachsen (CCS THOS) wurden auf der Grundlage eines systematischen Reviews zu Evaluations(rahmen)konzepten für telemedizinische Anwendungen (Suchzeitraum bis September 2014, Datenbanken Medline, Embase, HTA-Database, DARE, NHS EED) sowie einer zusätzlichen selektiven Literaturrecherche Vorschläge für Evaluationsgrundsätze abgeleitet. Diese wurden anschließend einem formalen Konsensverfahren (nominaler Gruppenprozess) unter Beteiligung relevanter Interessengruppen (Kostenträger, Leistungserbringer, Vertreter der Gesundheitspolitik, Wissenschaftler) unterzogen.
Ergebnisse
19 Arbeiten wurden in den systematischen Review eingeschlossen. Diese präsentierten entsprechend der vorab definierten Einschlusskriterien jeweils ein auf der Grundlage eines systematischen Reviews und/oder eines Konsensverfahrens erstelltes Evaluations(rahmen)konzept für telemedizinische Anwendungen. Die hieraus sowie aus der selektiven Literaturrecherche (23 Arbeiten) abgeleiteten Vorschläge für Evaluationsgrundsätze mündeten durch das formale Konsensverfahren in zehn konsentierten Grundsätzen, wovon acht einstimmig und zwei mit jeweils einer Enthaltung beschlossen wurden. Die Grundsätze beinhalten Kriterien für die Planung, Durchführung und das Berichten von Telemedizin-Evaluationen. Ihre Einhaltung ist für alle Nutzer der telemedizinischen Infrastruktur von CCS THOS verpflichtend. Darüber hinaus war deren Aufgreifen durch andere Projekte und Initiativen von Beginn an ausdrücklich beabsichtigt.
Schlussfolgerungen
Die verabschiedeten Grundsätze für die Evaluation telemedizinischer Anwendungen sind in Deutschland die ersten, die auf evidenz- und konsensbasierter Grundlage entwickelt worden sind. Aufgrund der Erstellungsmethodik besitzen sie eine starke wissenschaftliche und gesundheitspolitische Legitimation. Hierdurch, sowie aufgrund ihrer allgemeinen Anwendbarkeit, wird eine über die im Projekt CCS THOS erstellte Telemedizin-Plattform hinausgehende, breite Berücksichtigung dieser Standards in der deutschen Telemedizin-Landschaft empfohlen.
Fragestellung: In Deutschland nutzt jeder Funfte Gesundheits-Apps, um Fitness, Ernahrung oder das Selbstmanagement einer chronischen Krankheit zu unterstutzen. Das Angebot fur Diabetiker hat sich in einem Jahr fast verdoppelt. Der Nachweis der Wirksamkeit von Diabetes-Apps aus kontrollierten Studien steht bisher aus. Um bei Betroffenen direkt zu erheben, ob und wie Diabetes-Apps derzeit genutzt werden, wie Chancen und Risiken eingeschatzt und welche Unterstutzungsfunktionen erwartet werden, fuhrt HealthOn e.V. zusammen mit der Padagogischen Hochschule Freiburg und diabetesDE – Deutsche Diabetes-Hilfe eine anonyme Online-Befragung durch. Methodik: Mit einem Online-Fragebogen, der 19 Items (5-stufige Likert-Skala) umfasst, werden von 15.12. bis 15.02.2016 Typ-1 und Typ-2-Diabetiker befragt. Die Teilnehmeransprache erfolgt uber Fach- und Publikumspresse, Selbsthilfeforen, Blogs, sowie Twitter und Facebook. Die Daten werden in einer Subgruppenanalyse nach Alter, Diabetes-Typ, Erkrankungsdauer und bisheriger App-Nutzung statistisch ausgewertet. Ergebnisse: (Stand 30.01.2016) – Die Mehrheit der Befragten nutzt Gesundheits-Apps (61,1%, n = 239), die meisten davon eine Diabetes-App (91,8%), die sie auf eigene Faust in den App-Stores (64,4%) suchen. Alle Befragten wunschen sich Orientierungshilfen bei der Suche nach einer Diabetes-App (75,5%). Sie halten die automatisierte Ubertragung von Messwerten in digitale Tagebucher (87,8%), das Teilen von Messdaten mit dem Arzt (75,5%) sowie die Hilfe beim Erreichen von Ernahrungs- und Bewegungszielen (60,3%) fur hilfreich. Fur Nicht-Nutzer von Apps sind Kosten (41,9%) oder Angst vor dem Ausspahen ihrer Daten (32,3%) Haupthinderungsgrunde. Schlussfolgerungen: Diabetes-Apps bieten aus Sicht der meisten Betroffenen die Chance, das Selbstmanagement zu verbessern (77,5%, n = 298). Grunde fur Nichtnutzung sind vor allem mangelnde Angebotstransparenz sowie Bedenken im Hinblick auf Kosten und den Schutz personlicher Daten.
Patient-generated health data are coming into broader use across the health care spectrum and hold great promise as a means to improve care and health outcomes. At the same time, rapid evolution in the social media and mobile health (mHealth) market has promoted an environment in which creation and transmission of personal health information is easy, quick, and appealing to patients. However, adoption of social media and mHealth by providers is hampered by legal and regulatory concerns with regard to data ownership and data use. This article defines common forms of patient-generated health data (PGHD) and describes how PGHD is used in clinical settings. It explores issues related to protection of personal health information, including that of children and adolescents, data security, and other potential barriers such as physician licensure. It also discusses regulatory and legal considerations providers and patients should consider before using social media and mobile health apps.
Citation: Petersen C, DeMuro P. Legal and regulatory considerations associated with use of patient-generated health data from social media and mobile health (mHealth) devices. Appl Clin Inf 2015; 6: 16–26
http://dx.doi.org/10.4338/ACI-2014-09-R-0082
Smartphone health applications (‘apps’) are widely available but experts remain cautious about their utility and safety. We reviewed currently available apps for the detection of melanoma (July 2014), aimed at general community, patient and generalist clinician users.A proforma was used to extract and assess each app which met the inclusion criteria, and we undertook content analysis to evaluate their content, and the evidence applied in their development. Thirty nine apps were identified with the majority available only for Apple users. Over half (n=22) provided information or education about melanoma, UV exposure prevention advice, and skin self-examination strategies, mainly using the ABCDE method. Half (n=19) helped users take and store images of their skin lesions either for review by a dermatologist or for self-monitoring to identify change, an important predictor of melanoma; a similar number (n=18) used reminders to help users monitor their skin lesions. A few (n=9) offered expert review of images. Four apps provided a risk assessment to patients about the probability that a lesion was malignant or benign, and one app calculated users’ future risk of melanoma. None of the apps appeared to have been validated for diagnostic accuracy or utility using established research methods.Smartphone apps for detecting melanoma by non-specialist users have a range of functions including information, education, classification, risk assessment and monitoring change. Despite their potential usefulness, and while clinicians may choose to use apps that provide information to educate their patients, apps for melanoma detection require further validation of their utility and safety.This article is protected by copyright. All rights reserved.
Recent advancements in consumer directed personal computing technology have led to the generation of biomedically-relevant data streams with potential health applications. This has catalyzed international interest in Patient Generated Health Data (PGHD), defined as “health-related data – including health history, symptoms, biometric data, treatment history, lifestyle choices, and other information-created, recorded, gathered, or inferred by or from patients or their designees (i.e. care partners or those who assist them) to help address a health concern.”(Shapiro et al., 2012) PGHD offers several opportunities to improve the efficiency and output of clinical trials, particularly within oncology. These range from using PGHD to understand mechanisms of action of therapeutic strategies, to understanding and predicting treatment-related toxicity, to designing interventions to improve adherence and clinical outcomes. To facilitate the optimal use of PGHD, methodological research around considerations related to feasibility, validation, measure selection, and modeling of PGHD streams is needed. With successful integration, PGHD can catalyze the application of “big data” to cancer clinical research, creating both “n of 1” and population-level observations, and generating new insights into the nature of health and disease.
Asthma is one of the most common long-term conditions worldwide, which places considerable pressure on patients, communities and health systems. The major international clinical guidelines now recommend the inclusion of self management programmes in the routine management of patients with asthma. These programmes have been associated with improved outcomes in patients with asthma. However, the implementation of self management programmes in clinical practice, and their uptake by patients, is still poor. Recent developments in mobile technology, such as smartphone and tablet computer apps, could help develop a platform for the delivery of self management interventions that are highly customisable, low-cost and easily accessible.
To assess the effectiveness, cost-effectiveness and feasibility of using smartphone and tablet apps to facilitate the self management of individuals with asthma.
We searched the Cochrane Airways Group Register (CAGR), the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, CINAHL, Global Health Library, Compendex/Inspec/Referex, IEEEXplore, ACM Digital Library, CiteSeer(x) and CAB abstracts via Web of Knowledge. We also searched registers of current and ongoing trials and the grey literature. We checked the reference lists of all primary studies and review articles for additional references. We searched for studies published from 2000 onwards. The latest search was run in June 2013.
We included parallel randomised controlled trials (RCTs) that compared self management interventions for patients with clinician-diagnosed asthma delivered via smartphone apps to self management interventions delivered via traditional methods (e.g. paper-based asthma diaries).
We used standard methods expected by the Cochrane Collaboration. Our primary outcomes were symptom scores; frequency of healthcare visits due to asthma exacerbations or complications and health-related quality of life.
We included two RCTs with a total of 408 participants. We found no cluster RCTs, controlled before and after studies or interrupted time series studies that met the inclusion criteria for this systematic review. Both RCTs evaluated the effect of a mobile phone-based asthma self management intervention on asthma control by comparing it to traditional, paper-based asthma self management. One study allowed participants to keep daily entries of their asthma symptoms, asthma medication usage, peak flow readings and peak flow variability on their mobile phone, from which their level of asthma control was calculated remotely and displayed together with the corresponding asthma self management recommendations. In the other study, participants recorded the same readings twice daily, and they received immediate self management feedback in the form of a three-colour traffic light display on their phones. Participants falling into the amber zone of their action plan twice, or into the red zone once, received a phone call from an asthma nurse who enquired about the reasons for their uncontrolled asthma.We did not conduct a meta-analysis of the data extracted due to the considerable degree of heterogeneity between these studies. Instead we adopted a narrative synthesis approach. Overall, the results were inconclusive and we judged the evidence to have a GRADE rating of low quality because further evidence is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. In addition, there was not enough information in one of the included studies to assess the risk of bias for the majority of the domains. Although the other included study was methodologically rigorous, it was not possible to blind participants or personnel in the study. Moreover, there are concerns in both studies in relation to attrition bias and other sources of bias.One study showed that the use of a smartphone app for the delivery of an asthma self management programme had no statistically significant effect on asthma symptom scores (mean difference (MD) 0.01, 95% confidence interval (CI) -0.23 to 0.25), asthma-related quality of life (MD of mean scores 0.02, 95% CI -0.35 to 0.39), unscheduled visits to the emergency department (OR 7.20, 95% CI 0.37 to 140.76) or frequency of hospital admissions (odds ratio (OR) 3.07, 95% CI 0.32 to 29.83). The other included study found that the use of a smartphone app resulted in higher asthma-related quality of life scores at six-month follow-up (MD 5.50, 95% CI 1.48 to 9.52 for the physical component score of the SF-12 questionnaire; MD 6.00, 95% CI 2.51 to 9.49 for the mental component score of the SF-12 questionnaire), improved lung function (PEFR) at four (MD 27.80, 95% CI 4.51 to 51.09), five (MD 31.40, 95% CI 8.51 to 54.29) and six months (MD 39.20, 95% CI 16.58 to 61.82), and reduced visits to the emergency department due to asthma-related complications (OR 0.20, 95% CI 0.04 to 0.99). Both studies failed to find any statistical differences in terms of adherence to the intervention and occurrence of other asthma-related complications.
The current evidence base is not sufficient to advise clinical practitioners, policy-makers and the general public with regards to the use of smartphone and tablet computer apps for the delivery of asthma self management programmes. In order to understand the efficacy of apps as standalone interventions, future research should attempt to minimise the differential clinical management of patients between control and intervention groups. Those studies evaluating apps as part of complex, multicomponent interventions, should attempt to tease out the relative contribution of each intervention component. Consideration of the theoretical constructs used to inform the development of the intervention would help to achieve this goal. Finally, researchers should also take into account: the role of ancillary components in moderating the observed effects, the seasonal nature of asthma and long-term adherence to self management practices.
The primary objective was to determine if wireless remote monitoring with automatic clinician alerts reduces the time from a clinical event to a clinical decision in response to arrhythmias, cardiovascular (CV) disease progression, and device issues compared to patients receiving standard in-office care. A secondary objective was to compare the rates of CV health care utilization between patients in the remote and in-office arms.
In addition to providing life-saving therapy, implantable cardioverter-defibrillators collect advanced diagnostics on the progression of the patient's heart disease. Device technology has progressed to allow wireless remote monitoring with automatic clinician alerts to replace some scheduled in-office visits.
The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) study was a multicenter, prospective, randomized evaluation involving 1,997 patients from 136 clinical sites who underwent insertion of an implantable cardioverter-defibrillator (including cardiac resynchronization therapy devices) and were followed up for 15 months. Health care utilization data included all CV-related hospitalizations, emergency department visits, and clinic office visits.
The median time from clinical event to clinical decision per patient was reduced from 22 days in the in-office arm to 4.6 days in the remote arm (p < 0.001). The health care utilization data revealed a decrease in mean length of stay per CV hospitalization visit from 4.0 days in the in-office arm to 3.3 days in the remote arm (p = 0.002).
Wireless remote monitoring with automatic clinician alerts as compared with standard in-office follow-up significantly reduced the time to a clinical decision in response to clinical events and was associated with a significant reduction in mean length of CV hospital stay. (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision [CONNECT]; NCT00402246).
Monitoring implantable cardiac device function and patient condition is important. The Lumos-T Safely Reduces Routine Office Device Follow-Up (TRUST) trial tested the hypothesis that remote home monitoring with automatic daily surveillance (HM) is safe and effective for implantable cardioverter-defibrillator follow-up for 1 year and enables rapid physician evaluation of significant events.
In total, 1339 patients were randomized 2:1 to HM or conventional follow-up. Follow-up checks occurred at 3, 6, 9, 12, and 15 months after implantation. HM was used before office visits at 3 and 15 months in the HM group. At 6, 9, and 12 months, HM only was used but was followed by office visits if necessary. Conventional patients were evaluated with office visits only. Scheduled office visits and unscheduled evaluations, incidence of morbidity, and time elapsed from first event occurrence in each patient to physician evaluation were tracked for each group. HM and conventional patients were similar (age, 63.3+/-12.8 versus 64.0+/-12.1 years; gender, 72.0% versus 73.1% male; New York Heart Association class II, 55.9% versus 60.4%; pathology: left ventricular ejection fraction, 29.0+/-10.7% versus 28.5+/-9.8%; coronary artery disease, 64.8% versus 71.7%; primary prevention indication, 72.2% versus 73.8%; and dual-chamber implants, 57.8% versus 56.6%). HM reduced total in-hospital device evaluations by 45% without affecting morbidity. In the HM group, 85.8% of all 6-, 9-, and 12-month follow-ups were performed remotely only, indicating that HM provided sufficient assessment in the majority. Median time to evaluation was <2 days in the HM group compared with 36 days in the conventional group (P<0.001) for all arrhythmic events.
HM is safe and allows more rapid detection of actionable events compared with conventional monitoring in patients with implantable electronic cardiac devices.
On-demand or prophylactic home-treatment is currently the treatment of choice for haemophilia patients. To allow physicians to monitor the amount of factor concentrates administered, the patients document each factor injection in a paper-diary. Nevertheless, because of the fact that most patients visit their physicians only two to four times a year, there could be considerable delay in detecting medication problems. The aim of this pilot study was to assess whether an electronic documentation tool could successfully replace traditional paper-diaries for haemophilia A patients and enable the physician to have a timely overview of the patient's treatment. An electronic, hand-held documentation tool, Haemoassist, was developed. In this study, patients using prophylaxis and on-demand therapies documented their factor consumption both electronically and on paper-diaries. Documentations were compared and descriptively evaluated. Patients also completed a survey to evaluate the feasibility and gather their opinions on the Haemoassist system. Ten patients from two haemophilia treatment centres in Germany submitted a total of 548 records via hand-held device during the observation period, from March 2006 to February 2007. Comparison of electronic and paper-based records showed differing responses among patients with some patients entering more electronic and some others more paper-based documentations. In the questionnaires on feasibility and usefulness of Haemoassist, three patients preferred the electronic tool, two patients wanted to continue using paper-based diaries, and one had no preference. The study shows that an electronic documentation system is feasible for haemophilia patients and provides the physician with the opportunity to more closely monitor patients. However, not all patients seem to be qualified for using an electronic tool, and the tool has to run reliably without major errors for ensuring reliability and acceptability. In the future, Haemoassist might support quality assurance in haemophilia treatment and improve guidance in the home-care setting.
A recently published randomized controlled trial (RCT) showed that adherence to infusion diary record keeping was improved by the use of handheld computers. In this study, attitudes to record keeping were explored and patient preferences regarding the method of recording determined for the patients who participated in the trial. Qualitative study consisting of individual semi-structured interviews with 20 severely affected patients with haemophilia who participated in an RCT. Individuals were purposefully sampled based on their recent method of record keeping and whether child or adult. Analysis employed a constant comparative method to identify key themes from the data. Most individuals (19 of 20, 95%) considered record keeping to be important. They readily identified reasons to keep records: to benefit themselves, their families, clinical staff, product distributors and manufacturers. Keeping records helps them: feel a part of the health care team; have confidence they would be notified of product recalls; review their past history; improve their ability to advocate for themselves and improve communication among all parties. Record keeping, particularly when using paper diaries, can be burdensome and a challenge to maintain consistently. All 10 individuals (100%) who had used both paper diaries and handheld computers preferred the latter. Most patients understand that record keeping can be of benefit to them. Clinics can use this knowledge to inspire other patients by developing educational programmes that de-emphasize authority. In addition, given the evidence of both patients' preference for handheld computers, and the effectiveness of this approach documented in an RCT, switching to handheld computers is likely to improve record keeping.
Due to the increasing number of patients with an implantable cardioverter defibrillator (ICD), new options for ICD patient follow-up management are required.
Patients with ICD indication according to the guidelines received an ICD with Home Monitoring technology. The devices enabled the transmission of the relevant episode, therapy, and system integrity data. Patients were followed for 12 months with routine controls every 3 months. The physician analyzed the Home Monitoring data before the routine follow-up visit (FU) and gave a forecast on the necessity of the pending FU, which was compared with the evaluation after the FU. Based on the derived forecast reliability, a patient management scheme was developed and its impact on patient safety was assessed retrospectively.
A total of 271 patients were enrolled (40 f, mean age 62+/-12 years, mean LVEF 39+/-15%, 65% ischemic heart disease, 20% cardiomyopathy) and followed for 339+/-109 days. Of 908 pairs of Home Monitoring data and FU data evaluation, 129 there were false negative results for 92 patients. Safety concerns from false negative forecasts can be minimized with a patient management scheme containing the following elements: 1) never skip the first routine FU; 2) never skip a routine FU for a patient having already shown pacing threshold problems; 3) perform FU following hospitalizations; 4) perform FU following episode detection by the ICD; and 5) perform a routine FU if the patient reports symptoms. The retrospective analysis showed, that if the patients had been managed using this scheme, 503 of 1079 routine FU could have been skipped with only one safety concern, a three month delay in the detection of silent paroxysmal atrial fibrillation in one patient.
Home Monitoring in ICD therapy over 12 months is feasible. The data transmitted relevantly contribute to a remarkable reduction of follow-up burden and enable the individualization of routine follow-up.
Secondary use of health data applies personal health information (PHI) for uses outside of direct health care delivery. It includes such activities as analysis, research, quality and safety measurement, public health, payment, provider certification or accreditation, marketing, and other business applications, including strictly commercial activities. Secondary use of health data can enhance health care experiences for individuals, expand knowledge about disease and appropriate treatments, strengthen understanding about effectiveness and efficiency of health care systems, support public health and security goals, and aid businesses in meeting customers' needs. Yet, complex ethical, political, technical, and social issues surround the secondary use of health data. While not new, these issues play increasingly critical and complex roles given current public and private sector activities not only expanding health data volume, but also improving access to data. Lack of coherent policies and standard "good practices" for secondary use of health data impedes efforts to strengthen the U.S. health care system. The nation requires a framework for the secondary use of health data with a robust infrastructure of policies, standards, and best practices. Such a framework can guide and facilitate widespread collection, storage, aggregation, linkage, and transmission of health data. The framework will provide appropriate protections for legitimate secondary use.
Aktionsplan für elektronische Gesundheitsdienste 2012-2020 -innovative Gesundheitsfürsorge im 21
- Europäische Kommission
Europäische Kommission. Aktionsplan für elektronische Gesundheitsdienste 2012-2020 -innovative Gesundheitsfürsorge im 21.
Grünbuch über Mobile-Health-Dienste
Europäische Kommission. Grünbuch über Mobile-Health-Dienste
("mHealth") Brüssel: Referat H.1, Gesundheit und Wohlergehen 2014.
Available from http://ec.europa.eu/transparency/regdoc/rep/1/2014/
DE/1-2014-219-DE-F1-1.Pdf.
Gesundheits-und Versorgungs-Apps
- M Lucht
- R Bredenkamp
- M Boeker
- U Kramer
Lucht M, Bredenkamp R, Boeker M, Kramer U. Gesundheits-und
Versorgungs-Apps. Hintergründe zu deren Entwicklung und Einsatz.
Im Internet: https://docplayer.org/2645845-Gesundheits-und-versorgungs-appshintergruende-zu-deren-entwicklung-und-einsatz.html
Digitale Welt und Gesundheit. eHealth und mHealth -Chancen und Risiken der Digitalisierung im Gesundheitsbereich Bundesministerium für Justiz und Verbraucherschutz
- G Gigerenzer
- K Schlegel-Matthies
- G G Wagner
Gigerenzer G, Schlegel-Matthies K, Wagner GG. Digitale Welt und
Gesundheit. eHealth und mHealth -Chancen und Risiken der
Digitalisierung im Gesundheitsbereich Bundesministerium für Justiz
und Verbraucherschutz 2016. https://www.bmjv.de/SharedDocs/
Downloads/DE/News/Artikel/01192016_Digitale_Welt_und_
Risiken von Gesundheits-Apps (CHA-RISMHA). Albrecht, Urs-Vito. Chancen und Risiken von Gesundheits-Apps (CHARISMHA)
- U-V Albrecht
- Chancen
Albrecht U-V. Chancen und Risiken von Gesundheits-Apps (CHA-RISMHA). Albrecht, Urs-Vito. Chancen und Risiken von Gesundheits-Apps (CHARISMHA). Braunschweig: Medizinische Hochschule
Hannover; 2016: 14-47