eHealth Apps Replacing or Complementing Health Care Contacts: Scoping Review on Adverse Effects

Abstract

BackgroundThe use of eHealth has increased tremendously in recent years. eHealth is generally considered to have a positive effect on health care quality and to be a promising alternative to face-to-face health care contacts. Surprisingly little is known about possible adverse effects of eHealth apps.ObjectiveWe conducted a scoping review on empirical research into adverse effects of eHealth apps that aim to deliver health care at a distance. We investigated whether adverse effects were reported and the nature and quality of research into these possible adverse effects.MethodsFor this scoping review, we followed the five steps of Arksey and O’Malley’s scoping review methodology. We searched specifically for studies into eHealth apps that replaced or complemented the face-to-face contact between a health professional and a patient in the context of treatment, health monitoring, or supporting self-management. Studies were included when eHealth and adverse effects were mentioned in the title or abstract and when empirical data on adverse effects were provided. All health conditions, with the exception of mental health conditions, all ages, and all sample sizes were included. We examined the literature published between December 2012 and August 2017 in the following databases: PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Web of Science, and the Cochrane Library. The methodological quality of the studies was assessed using the Critical Appraisal Skills Programme (CASP) checklists.ResultsOur search identified 79 papers that were potentially relevant; 11 studies met our inclusion criteria after screening. These studies differed in many ways and the majority were characterized by small research populations and low study quality. Adverse effects are rarely subject to systematic scientific research. So far, information on real adverse effects is mainly limited to incidental reporting or as a bycatch from qualitative pilot studies. Despite the shortage of solid research, we found some indications of possible negative impact on patient-centeredness and efficiency, such as less transparency in the relationship between health professionals and patients and time-consuming work routines.ConclusionsThere is a lack of high-quality empirical research on adverse effects of eHealth apps that replace or complement face-to-face care. While the development of eHealth apps is ongoing, the knowledge with regard to possible adverse effects is limited. The available research often focuses on efficacy, added value, implementation issues, use, and satisfaction, whereas adverse effects are underexplored. A better understanding of possible adverse effects could be a starting point in improving the positive impact of eHealth-based health care delivery.

Improved aftercare in LVAD patients: Development and feasibility of a smartphone application as a first step for telemonitoring

“…Prior to the introduction of routine telemedical aftercare, the potential negative impacts of such a step must also be taken into account. Possible adverse effects of this form of aftercare have yet to be sufficiently researched; the danger definitely exists, however, that telemedical applications could not only complement personal contact with medical staff, but largely replace it. This would not be a good development, in particular for LVAD patients, and total replacement should be avoided because telemonitoring approaches have their limitations.…”

Why is it so difficult to govern mobile apps in healthcare?

“…Take, for instance, a symptom checker that would be a class 1 medical device in the UK, but is not considered a medical device in Australia, and in the USA would not have regulations enforced by the Food and Drug Administration. Because developers are not required to demonstrate performance and show effectiveness, the quality of evaluation studies is poor,8 and there is little attention to safety 15. Current European medical device regulation (CE marking) presumes apps are clinically effective, and therefore pushes liabilities for use errors, even if caused by software bugs, onto end users.…”

“…Because developers are not required to demonstrate performance and show effectiveness, the quality of evaluation studies is poor, 8 and there is little attention to safety. 15 Current European medical device regulation (CE marking) presumes apps are clinically effective, and therefore pushes liabilities for use errors, even if caused by software bugs, onto end users. Again, this contrasts with pharmaceutical development, which includes registering experiments and a mature peer-reviewed publication culture.…”

Psychologische Behandlungsverfahren bei Kopfschmerz

“…Kopfschmerz-Apps sind in wissenschaftlichen Studien bisher selten untersucht worden [89], ebenso mögliche Nebenwirkungen [90]. Es fehlt an wissenschaftlicher Expertise und es bedarf einheitlicher Qualitätsstandards [87,91].…”