Electronic, mobile, digital health approaches in cardiology and for cardiovascular health.
Official partner journal of the European Congress on eCardiology and eHealth
JMIR Cardio (inaugural Editor-in-Chief: Nico Bruining) is a sister journal of the Journal of Medical Internet Research (JMIR), the top cited journal in health informatics (Impact Factor 2016: 5.175). It covers electronic / digital health approaches in cardiology and for cardiovascular health, which includes ehealth and mhealth approaches for the prevention and treatment of cardiovascular conditions.
JMIR Cardio is also the official journal of the European Congress on eCardiology and eHealth. Best papers presented at the conference are selected for JMIR Cardio and as official partner organization, JMIR authors receive a discount (Promo Code: JMIRECARDIO17).
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Heart Rate Monitoring Apps: the Rules Have Just Changed - or Have They? What Engineers and Researchers Ought to Know About Regulation (EU) 2017/745.
Date Submitted: Jun 9, 2017
Open Peer Review Period: Jun 9, 2017 - Aug 4, 2017
Background: After years in the making, on 5 April 2017 the European Parliament and Council finally adopted Regulation (EU) 2017/745, the new Medical Device Regulation (MDR), repealing the existing Med...
Background: After years in the making, on 5 April 2017 the European Parliament and Council finally adopted Regulation (EU) 2017/745, the new Medical Device Regulation (MDR), repealing the existing Medical Device Directive (MDD) 93/42/EEC. Though long anticipated, this shift in policy will have strong and lasting effects in the medical devices industry. Objective: This Article focuses specifically on the classification of software as potential medical device under MDD and MDR and examines whether or not the regulatory framework for apps has changed substantially and what (if any) impact is to expected. It is aimed primarily at researchers and engineers unfamiliar with regulatory requirements for medical devices. This is of particular relevance as with the exponential growth of fitness and health-related apps the lines between toys, lifestyle products and medical devices have increasingly blurred. Methods: The recently published European Medical Device Regulation is analyzed and compared to the preceding MDD. Results: The previous regulatory framework already provided for the possibility of apps to fall under the definition of medical devices and classification rules for active medical devices applied. Under the new MDR the threshold for classifying as medical device has considerably been lowered. Conclusions: The adoption of the new European regulation on medical devices entails the serious risk that manufacturers previously unaffected by the medical devices regulatory framework may now unwillingly and unwittingly find themselves in the arena of medical device manufacturers.
User Participation and Engagement with the See Me Smoke-Free mHealth App: Results of a Prospective Feasibility Trial
Date Submitted: Apr 21, 2017
Open Peer Review Period: May 31, 2017 - Jul 14, 2017
Background: The See Me Smoke-Free (SMSF) mobile health (mHealth) application (app) was developed to help women quit smoking by targeting concerns about body weight, body image, and self-efficacy throu...
Background: The See Me Smoke-Free (SMSF) mobile health (mHealth) application (app) was developed to help women quit smoking by targeting concerns about body weight, body image, and self-efficacy through cognitive behavioral techniques and guided imagery audio files addressing smoking, diet, and physical activity. A feasibility trial found associations between SMSF usage and positive treatment outcomes. This paper reports a detailed exploration of program use among those who downloaded the app, and the relationship between program use and treatment outcomes. Objective: To determine whether: 1) participants were more likely to set quit dates, be current smokers, and report higher levels of smoking at baseline than non-participants; 2) participants opened the app and listened to audio files more frequently than non-participants; and 3) participants with more app usage had a higher likelihood of smoking abstinence at follow-up. Methods: The SMSF feasibility trial was a single arm, within-subjects, prospective cohort study with assessments at baseline, 30- and 90-days post-enrollment. The SMSF app was deployed on the Google Play store for download, and basic profile characteristics were obtained for all app installers. Additional variables were assessed for study participants. Participants were prompted to use the app daily during study participation. Crude differences in baseline characteristics between trial participants and non-participants were evaluated using t-tests (continuous variables) and Fisher’s exact tests (categorical variables). Exact Poisson tests were used to assess group-level differences in mean usage rates over the full study period, using aggregate Google Analytics data on participation and usage. Negative binomial regression models were used to estimate associations of app usage with participant baseline characteristics, after adjustment for putative confounders. Associations between app usage and smoking abstinence were assessed using separate logistic regression models for each outcome measure. Results: Participants (n=151) were more likely than non-participants (n=96) to report female gender (P < 0.02) and smoking in the 30 days prior to enrollment (P < 0.0001). Participants and non-participants opened the app and updated quit dates at the same average rate (Rate ratio (RR) 0.98; 95% CI: 0.92, 1.04; P = 0.43), but participants started audio files (RR 1.07; 95% CI: 1.00, 1.13; P < 0.04) and completed audio files (RR 1.11; 95% CI: 1.03, 1.18; P < 0.003) at significantly higher rates than non-participants. Higher app usage among participants was generally associated with increased smoking cessation, and most effect sizes suggested strong associations, though generally without statistical significance. Conclusions: The current study suggests potential efficacy of the SMSF app, as increased usage was generally associated with higher smoking abstinence. A planned randomized controlled trial will assess the SMSF app’s efficacy as an intervention tool to help women quit smoking. Clinical Trial: ClinicalTrials.gov NCT02972515
Low- and No-Cost Strategies to Recruit Women to a Mobile Health Smoking Cessation Trial
Date Submitted: Jan 19, 2017
Open Peer Review Period: May 31, 2017 - Jul 14, 2017
Background: Successful recruitment and retention of adequate numbers of participants to mobile health (mHealth) studies remains a challenge. Given that researchers must decide how to invest limited re...
Background: Successful recruitment and retention of adequate numbers of participants to mobile health (mHealth) studies remains a challenge. Given that researchers must decide how to invest limited recruitment resources, it is important to identify the most effective recruitment strategies, defined as those that incur low costs relative to participant yield. Objective: The objective of this manuscript is to describe the development and implementation process for the recruitment phase of an mHealth intervention designed to increase smoking cessation among weight-concerned women smokers. These recruitment methods could be applicable across a range of mHealth studies. Methods: Study information was released to the media in multiple phases. First, local city and state media were contacted, followed by national women’s health media, and finally outlets in states with high smoking rates. Stories and mentions resulting from the press releases (earned media) were disseminated via existing department and new study-specific social media accounts. Strategic hashtags were used in Facebook and Twitter posts to connect with broader smoking cessation campaigns. Posts were also made to third-party Facebook smoking cessation communities and Internet classifieds sites. Results: Media coverage was documented across 75 publications and radio/television broadcasts, 35 of which were local, 39 national, and 1 international. Between March 30th and July 31st, 2015, 151 participants were successfully recruited to the study. Conclusions: Leveraging social media, and coordinating with university public affairs offices were effective and low-cost strategies to earn media coverage, and reach potential participants. Clinical Trial: Not Applicable