Anesthesia and mHealth - a Survey

Background mHealth, the practice of medicine aided by mobile devices is a growing market. Although the offer on Anesthesia applications (Apps) is quite varied, representative formal assessments on the views of anesthesia practitioners on its use and potential place in daily practice is lacking. This survey aimed thus to cross-assess the Belgian anesthesia population on the use of smartphone Apps and peripherals. Methods The survey was exclusively distributed as an online anonymous questionnaire. Sharing took place via hyperlink forwarding by the Belgian Society for Anesthesia and Reanimation (BSAR) and by the Belgian Association for Regional Anesthesia (BARA) to all registered members. The �rst answer took place on 5 September 2018, the last on 22 January 2019. Results 349 answers were obtained (26.9% corresponding to trainees, 73.1% to specialists). Anesthesiologists were positively con�dent that Apps and peripherals could help improve anesthesia care (57.0% and 47.9%, respectively, scored 4 or 5, in a scale from 0 - 5). Anesthesia trainees were signi�cantly more con�dent that specialists on mobile Apps (72.1% and 51.6%, respectively). The usefulness of Apps and Peripherals was rated 1 or below (on a 0 to 5 scale) by 9.5% and 14.6% of the subjects. Trainees signi�cantly used mobile apps more than specialists (66.7% vs. 37.4%, respectively). The preferred category of mobile Apps was dose-calculating applications (39.8%), followed by digital books (21.5%) and Apps for active perioperative monitoring (20.3%). Conclusions Belgian Anesthesia practitioners show a signi�cant positive attitude towards smartphone Apps and Peripherals.


Background
Smartphones are an ubiquitous phenomenon.The massive production of these multisensory devices has reduced their overall cost and increased their societal penetrance.Their high processing capacity entails a rather useful leverage for healthcare in general, a sector where data is abundant and its processing relevant for clinical decision-making [1,2].These advantageous features have been quickly assimilated by anesthesiologists, and dedicated anesthesia applications for various perioperative purposes have been continuously sprouting [3].
Commonly referred to as "mHealth" (abbreviation for Mobile Health), the practice of medicine aided by mobile devices is a growing market.In the United States of America (USA), this sector has been estimated to be worth more than 28 billion dollars in 2018, and predicted to surpass the 100 billion dollar barrier by 2023 [4].Despite its exponential growth, regulation has been lagging behind and Food and Drug Administration (FDA) data shows that from a pool of more that 150.000 mobile applications (Apps) within the Health/Wellness category, only around 200 (0,1%) had been submitted to standardized governmental validation processes [5].
Despite the high mobile applications output, formal surveying of the views of anesthesia providers on these applications is scarce [3,5].Green et al have conducted one of the most complete, although non-representative, studies on the pattern of utilization of smartphone applications by anesthesiologists in the USA [3].
The aim of the present survey was to speci cally cross-assess the Belgian anesthesia population on this same subject, and to discuss the results with respect of the current legal European framework around mHealth.
The survey was exclusively distributed as an online anonymous questionnaire (Google Forms platform) for traceability purposes.Sharing took place via hyperlink distribution by the Belgian Society for Anaesthesia and Reanimation (BSAR) and by the Belgian Association for Regional Anaesthesia (BARA) to all registered members.The rst answer took place on 5 September 2018, the last on 22 January 2019.
The original survey can be consulted at: https://goo.gl/forms/7job24qgFOPXpUD12It was divided in two main sections: one pertaining to Smartphone Applications themselves, another to Smartphone Peripherals.Each section was identically subdivided and sequentially evaluated the following topics: • Con dence that Smartphone applications / peripherals can help improve Anesthesia care and why.
• Phase of perioperative care in which Smartphone applications / peripherals are most useful.
• Which sort of Smartphone applications appeal the user the most.
• Which Smartphone applications / peripherals the user employs in his/her daily practice.
• What are the user's wishes on the development of future Smartphone applications / peripherals.Data presentation and statistical analyses: The data are presented as number, percentage and the 95% con dence intervals [95%CI] related to the evaluated questions are given.The data was analysed globally, and by subgroups (consultants vs. trainees).
Concerning the perioperative care phase in which Applications or Peripherals could be more useful, 71.1% [95%CI: 65.5 -76.7%] and 57.0%[95%CI: 50.1 -63.9%], respectively, considered them to have a potential use in all phases of the perioperative care (Fig. 6 and 7).
The categories in which anesthesiologists would like to see development of smartphone peripheral devices are illustrated in Fig. 8.

Discussion
According to data from the Belgian National Institute for Health and Disability Insurance (RIZIV / INAMI), in the beginning of 2016, Belgium had 2441 active anesthesia specialists (certi ed specialists and trainees) [6].This sets this survey´s cross-sectional percentage at 14.2% of the total active Belgian anesthesiologists, 13.2% of the certi ed Belgian anesthesiologists, and 17.5% of the Belgian anesthesiogy trainees.Concerning the accredited specialists (diplomaholding), it is however not known if all them are dedicated in exclusivity to anesthesia-related elds such as Intensive care, Emergency department or Pain clinic.It is thus possible that the representability percentage of this survey is different than calculated, although practically very di cult to con rm.
In general, these survey results agree with the ndings of Green et al on the American anesthesiologists population: Apps enjoy a signi cant degree of con dence and believed to have a potential use on all phases of perioperative care [3].Peripherals also enjoy a high con dence on potential use, rating 57.0% [95%CI: 50.1 -63.9%] of the responders their con dence as 80% or higher that these can be useful in Anesthesia care.Nine and a half percent [95%CI: 0 -19,5%] of the surveyees rated Apps' usefulness in anesthesia as 1 or bellow (on a 0 to 5 scale), and 14.6% [95%CI: 4.9 -24.3%] gave the same rating when asked about Peripherals.Thus, although there is a comparable optimism for Apps and Peripherals, the latter enjoy a proportionally greater degree of disbelief.The reasons for this discrepancy were not evaluated by this questionnaire, but one can speculate that the underdeveloped regulated market of smartphone peripherals for diagnostic aid is still not rmly established within today´s anesthesia practice.Although the major players have already created a dedicated peripherals market line (for example, Philips Lumify portable echography series), convincing of practitioners on their usefulness is still needed.Curiously, when asked on which peripherals they wanted to see developed, 61.7% of the anesthesiologists answered "Echography".This area is one of the more exploited in terms of smartphone peripherals, and has been explored both by the major players in the medical device industry, as well as by less known competitors.
Although not being able to put forward signi cance numbers, some of the answers on our questionnaire suggested that some of the practitioners did know of the existence of such products but found them economically inaccessible.Other, however, suggested they had no knowledge of such devices.Another possible reason that might contribute to the greater disbelief might relate to the medical use of an originally partially non-medical device.Although it seems logical that controlled CE-labelling (Conformité Européenne) of smartphone peripherals for medical use might help overcome this, the subjective factor cannot be underestimated.Just like heavy, well designed and good tting over-head headphones feel subconsciously better than in-ear equivalents, traditional anesthesia monitors might still convey more con dence [7].
In line with the study of Green et al, dosage apps (static and dynamic) were chosen by the majority as the most useful [3].Digital books and perioperative apps followed.
As opposed to the study of Green et al, our group found signi cant differences between anesthesia trainees and specialists.Although there was a major positivity towards mobile apps in both groups, training anesthesiologists displayed a signi cantly higher con dence on mobile apps than consultants (72.1% vs 51.6%, respectively).This positivity trend held for smartphone peripherals, although with overlapping 95% con dence intervals.The reasons for this differences can only be speculated on.These de nitely promising technologies are increasingly being introduced in our daily practice and play an important facilitating role.However, one must not forget that these freely available tools are not always subject to formal approval procedures that scienti cally validate their clinical use.Most of these are part of the off-label/"use at own risk" category (commonly referred to as "Grey Area Apps") -applications freely available without formal evaluation of their function for their stated (medical) use [8].Taking this into mind, the European Union has created between 2016 and 2017 a workgroup for the development of mHealth assessment guidelines [8].However, the group was not able to endorse concrete guidelines by failure to reach a minimal intra-group consensus [9].As of this moment, Grey Area Apps remain unregulated.There is, however, a non-binding "privacy code of conduct on mobile health apps" that outlines the core values that should guide mobile health application development [10].It provides a theoretical competitive advantage against non-conform Applications and speeds up an eventual CE-label request.As for applications aiming for a formal regulated national market entry, compliance with the EU regulation 2017/745 (from 5 April 2017) is mandatory.Together with the EU norm 2017/746, they regulate the European market of medical devices since May 2017.European Union state members fall, thus, under these norms.
It is thus obvious that mobile Applications and Peripherals are quickly permeating all phases of Healthcare, with the right steps are being taken for their scienti cally validated integration.Peripherals still lag behind mobile applications although they constitute an economically and clinically important area.Care must still be taken owing the majority of available Apps fall within the unregulated category of "Grey Area Apps".Last, but not least, care must also be taken to avoid over-reliability/dependency on Apps, with the consequent side-tracking of basic clinical skills.

Conclusions
Belgian Anesthesia practitioners show a signi cant positive attitude towards smartphone Apps and Peripherals, mirroring international reported trends within other medical sectors.There is evidence of an international recognition of the potential of these technologies within the healthcare domain, with consequently rising regulatory efforts from medical societies and national legislative bodies.

Declarations 1. Ethics approval and consent to participate
The present study was approved by Ethical Committee of the Universitair Ziekenhuis Brussel, Belgium (Reference 2018/435, B.U.N. 143201837927), and registered at the ClinicalTrials.govdatabase (Identi er: NCT03750084).

Consent for publication
Informed consent was obtained from every survey participant.

Availability of data and materials
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Figures
Figure 1 Subspecialty stacked distribution of responding Anesthesia Specialists (one specialist can be accounted for more than once if he holds multiple subspecialty competences) Figure 2 Apps (left -blue) vs Peripherals (right -orange) -Con dence level (scale: 0 to 5) ("How con dent are you that Smartphone Apps can help improve anesthesia care?" / "How con dent are you that combining your smartphone with a dedicated monitoring peripheral can help improve anesthesia care?") Figure 3 Apps Con dence level (scale: 0 to 5): Specialists (left) vs Trainees (right) Peripherals Con dence level (scale: 0 to 5): Specialists (left) vs. trainees (right) Categorization of the most appealing Apps (absolute vote numbers per category) ("Which kind of Apps appeal you the most?") Figure 6 Phase in which Smartphone Apps can be more useful (n) ("In which phase of perioperative care can Smartphone Apps be more useful?")Figure 7 Phase in which Smartphone Peripherals can be more useful (n) ("In which phase of perioperative care can Smartphone Peripherals be more useful?")Figure 8 Wishes for smartphone peripheral device development per monitoring category ("Which peripherals would you like to see developed in the coming future?")