iCHECK-DH: Guidelines and Checklist for the Reporting on Digital Health Implementations.

BACKGROUND: Implementation of digital health technologies has grown rapidly, but many remain limited to pilot studies due to challenges, such as a lack of evidence or barriers to implementation. Overcoming these challenges requires learning from previous implementations and systematically documenting implementation processes to better understand the real-world impact of a technology and identify effective strategies for future implementation. OBJECTIVE: A group of global experts, facilitated by the Geneva Digital Health Hub, developed the Guidelines and Checklist for the Reporting on Digital Health Implementations (iCHECK-DH, pronounced "I checked") to improve the completeness of reporting on digital health implementations. METHODS: A guideline development group was convened to define key considerations and criteria for reporting on digital health implementations. To ensure the practicality and effectiveness of the checklist, it was pilot-tested by applying it to several real-world digital health implementations, and adjustments were made based on the feedback received. The guiding principle for the development of iCHECK-DH was to identify the minimum set of information needed to comprehensively define a digital health implementation, to support the identification of key factors for success and failure, and to enable others to replicate it in different settings. RESULTS: The result was a 20-item checklist with detailed explanations and examples in this paper. The authors anticipate that widespread adoption will standardize the quality of reporting and, indirectly, improve implementation standards and best practices. CONCLUSIONS: Guidelines for reporting on digital health implementations are important to ensure the accuracy, completeness, and consistency of reported information. This allows for meaningful comparison and evaluation of results, transparency, and accountability and informs stakeholder decision-making. i-CHECK-DH facilitates standardization of the way information is collected and reported, improving systematic documentation and knowledge transfer that can lead to the development of more effective digital health interventions and better health outcomes.

Correction: iCHECK-DH: Guidelines and Checklist for the Reporting on Digital Health Implementations.

[This corrects the article DOI: 10.2196/46694.].

Ethical considerations of e-cigarette use for tobacco harm reduction.

Due to their similarity to tobacco cigarettes, electronic cigarettes (e-cigarettes) could play an important role in tobacco harm reduction. However, the public health community remains divided concerning the appropriateness of endorsing a device whose safety and efficacy for smoking cessation remain unclear. We identified the major ethical considerations surrounding the use of e-cigarettes for tobacco harm reduction, including product safety, efficacy for smoking cessation and reduction, use among non-smokers, use among youth, marketing and advertisement, use in public places, renormalization of a smoking culture, and market ownership. Overall, the safety profile of e-cigarettes is unlikely to warrant serious public health concerns, particularly given the known adverse health effects associated with tobacco cigarettes. As a result, it is unlikely that the population-level harms resulting from e-cigarette uptake among non-smokers would overshadow the public health gains obtained from tobacco harm reduction among current smokers. While the existence of a gateway effect for youth remains uncertain, e-cigarette use in this population should be discouraged. Similarly, marketing and advertisement should remain aligned with the degree of known product risk and should be targeted to current smokers. Overall, the available evidence supports the cautionary implementation of harm reduction interventions aimed at promoting e-cigarettes as attractive and competitive alternatives to cigarette smoking, while taking measures to protect vulnerable groups and individuals.

Electronic cigarettes in North America: history, use, and implications for smoking cessation.

BACKGROUND: Designed to mimic the look and feel of tobacco cigarettes, electronic cigarettes (e-cigarettes) may facilitate smoking cessation. However, the efficacy and safety of e-cigarette use for this purpose remain poorly understood. Our objectives were to review the available data on the efficacy and safety of e-cigarettes for smoking cessation and to consider issues relevant to the context in which they are used, including product awareness and regulatory and ethical concerns. METHODS AND RESULTS: We systematically searched PubMed for randomized controlled trials and uncontrolled, experimental studies involving e-cigarettes. Included studies were limited to English or French language reports. Quality assessment was performed according to the Cochrane Risk of Bias tool. We identified 169 publications, of which 7 studies were included. Studies have concluded that e-cigarettes can help reduce the number of cigarettes smoked and may be as effective for smoking cessation as the nicotine patch. Although there is a lack of data concerning the safety and efficacy of e-cigarettes as a smoking cessation therapy, available evidence showed no significant difference in adverse event rates between e-cigarettes and the nicotine patch. E-cigarettes are widely used among smokers attempting to quit. However, significant international variation remains in the regulatory mechanisms governing the sale and distribution of e-cigarettes. Ethical concerns surround the use of e-cigarettes among minors and their potential to undermine efforts to reduce cigarette smoking. CONCLUSION: Given the limited available evidence on the risks and benefits of e-cigarette use, large, randomized, controlled trials are urgently needed to definitively establish their potential for smoking cessation.

Assessing the impact of multidrug-resistant tuberculosis in children: an exploratory qualitative study.

BACKGROUND: While the prevalence of multidrug-resistant (MDR) tuberculosis (TB) is high among children in the Western Cape of South Africa, the psychosocial implications of treatment for children with MDR-TB remain poorly understood. We sought to explore how MDR-TB and its treatment impact children on an individual, familial, and social level. METHODS: Semi-structured interviews were conducted with 20 children and caregivers purposively sampled from a prospective clinical cohort of children. The sample was stratified by age at the start of treatment (children >10 years, and 5-10 years). Caregiver proxy interviews were conducted with younger children, supplemented with child interviews; older children were interviewed directly, supplemented with caregiver proxy interviews. Data were analysed using grounded theory. RESULTS: Findings revealed pill volume and adverse effects produced significant physical, psychological and academic disturbances in children. Adverse effects related to the medication were important obstacles to treatment adherence. While there appear to be no long-lasting effects in younger children, a few older children showed evidence of persisting internalised stigma. Caregivers suffered important treatment-related financial and psychological costs. Community support, notably through the continued involvement of children in strong social networks, promoted resilience among children and their families. CONCLUSIONS: We found that the current treatment regimen for childhood MDR-TB has significant psychological, academic, and financial impacts on children and their families. There is a need for psychosocial support of children and caregivers to mitigate the negative effects of community stigma, and to manage the stressors associated with chronic illness.

Consensus standards for introductory e-learning courses in human participants research ethics.

This paper reports the results of a workshop held in January 2013 to begin the process of establishing standards for e-learning programmes in the ethics of research involving human participants that could serve as the basis of their evaluation by individuals and groups who want to use, recommend or accredit such programmes. The standards that were drafted at the workshop cover the following topics: designer/provider qualifications, learning goals, learning objectives, content, methods, assessment of participants and assessment of the course. The authors invite comments on the draft standards and eventual endorsement of a final version by all stakeholders.

A Mobile App (Concerto) to Empower Hospitalized Patients in a Swiss University Hospital: Development, Design, and Implementation Report.

BACKGROUND: Patient empowerment can be associated with better health outcomes, especially in the management of chronic diseases. Digital health has the potential to promote patient empowerment. OBJECTIVE: Concerto is a mobile app designed to promote patient empowerment in an in-patient setting. This implementation report focuses on the lessons learned during its implementation. METHODS: The app was conceptualized and prototyped during a hackathon. Concerto uses hospital information system (HIS) data to offer the following key functionalities: a care schedule, targeted medical information, practical information, information about the on-duty care team, and a medical round preparation module. Funding was obtained following a feasibility study, and the app was developed and implemented in four pilot divisions of a Swiss University Hospital using institution-owned tablets. IMPLEMENTATION (RESULTS): The project lasted for 2 years with effective implementation in the four pilot divisions and was maintained within budget. The induced workload on caregivers impaired project sustainability and warranted a change in our implementation strategy. The presence of a killer function would have facilitated the deployment. Furthermore, our experience is in line with the well-accepted need for both high-quality user training and a suitable selection of superusers. Finally, by presenting HIS data directly to the patient, Concerto highlighted the data that are not fit for purpose and triggered data curation and standardization initiatives. CONCLUSIONS: This implementation report presents a real-world example of designing, developing, and implementing a patient-empowering mobile app in a university hospital in-patient setting with a particular focus on the lessons learned. One limitation of the study is the lack of definition of a "key success" indicator.

Taxing junk food to counter obesity.

We examined the advantages and disadvantages of implementing a junk food tax as an intervention to counter increasing obesity in North America. Small excise taxes are likely to yield substantial revenue but are unlikely to affect obesity rates. High excise taxes are likely to have a direct impact on weight in at-risk populations but are less likely to be politically palatable or sustainable. Ultimately, the effectiveness of earmarked health programs and subsidies is likely to be a key determinant of tax success in the fight against obesity.

"To Err Is Evolution": We Need the Implementation Report to Learn.

JMIR Medical Informatics is pleased to offer implementation reports as a new article type. Implementation reports present real-world accounts of the implementation of health technologies and clinical interventions. This new article type is intended to promote the rapid documentation and dissemination of the perspectives and experiences of those involved in implementing digital health interventions and assessing the effectiveness of digital health projects.

Gamified Physical Rehabilitation for Older Adults With Musculoskeletal Issues: Pilot Noninferiority Randomized Clinical Trial.

BACKGROUND: Resource-rich countries are facing the challenge of aging societies, a high risk of dependence, and a high cost of care. Researchers attempted to address these issues by using cost-efficient, innovative technology to promote healthy aging and regain functionality. After an injury, efficient rehabilitation is crucial to promote returning home and prevent institutionalization. However, there is often a lack of motivation to carry out physical therapies. Consequently, there is a growing interest in testing new approaches like gamified physical rehabilitation to achieve functional targets and prevent rehospitalization. OBJECTIVE: The purpose of this study is to assess the effectiveness of a personal mobility device compared with standard care in the rehabilitation treatment of patients with musculoskeletal issues. METHODS: A total of 57 patients aged 67-95 years were randomly assigned to the intervention group (n=35) using the gamified rehabilitation equipment 3 times a week or to the control group (n=22) receiving usual standard care. Due to dropout, only 41 patients were included in the postintervention analysis. Outcome measures included the short physical performance battery (SPPB), isometric hand grip strength (IHGS), functional independence measure (FIM), and the number of steps. RESULTS: A noninferiority related to the primary outcome (SPPB) was identified during the hospital stay, and no significant differences were found between the control and intervention groups for any of the secondary outcomes (IHGS, FIM, or steps), which demonstrates the potential of the serious game-based intervention to be as effective as the standard physical rehabilitation at the hospital. The analysis by mixed-effects regression on SPPB showed a group×time interaction (SPPB_I_t1=-0.77, 95% CI -2.03 to 0.50, P=.23; SPPB_I_t2=0.21, 95% CI -1.07 to 0.48, P=.75). Although not significant, a positive IHGS improvement of more than 2 kg (Right: 2.52 kg, 95% CI -0.72 to 5.37, P=.13; Left: 2.43 kg, 95% CI -0.18 to 4.23, P=.07) for the patient from the intervention group was observed. CONCLUSIONS: Serious game-based rehabilitation could potentially be an effective alternative for older patients to regain their functional capacities. TRIAL REGISTRATION: ClinicalTrials.gov NCT03847454; https://clinicaltrials.gov/ct2/show/NCT03847454.

Smoking Cessation in Patients With Acute Coronary Syndrome.

Over 30% of the nearly 1 million North Americans hospitalized annually with an acute coronary syndrome (ACS) are smokers. Despite a substantially increased risk of morbidity and mortality, 2/3 of patients who quit smoking after ACS return to smoking within 1 year. To summarize the evidence of smoking cessation in patients hospitalized after ACS, we systematically reviewed all randomized controlled trials of pharmacologic and behavioral smoking cessation therapies in patients with ACS. In addition, we reviewed the clinical considerations surrounding the use of smoking cessation therapies, including their broad mechanisms of action and possible alternative treatments, including cardiac rehabilitation programs and electronic cigarettes. A total of 7 randomized controlled trials met our inclusion criteria (4 pharmacotherapies and 3 behavioral therapies). In pharmacologic trials, only varenicline increased point prevalence abstinence at 12 months. Behavioral interventions produced significantly improved abstinence rates at 6 and 12 months. However, these studies had substantial limitations affecting their generalizability. Overall, currently available smoking cessation therapies are limited in their efficacy in patients hospitalized after ACS. Because of the relative scarcity of data and the urgency of establishing clinical guidelines, there is a critical need to continue examining the efficacy and safety of smoking cessation interventions in patients hospitalized after ACS.

Electronic cigarettes: A comparison of national regulatory approaches.

E-cigarettes have been readily available to global markets since 2004. However, regulations have lagged behind popular use and availability. As policies emerging from national health agencies have an important role to play in shaping consumer health, we examined the existing and upcoming national regulations surrounding e-cigarette availability and use in a convenience sample of English- and French-speaking countries, including Canada, the United States, the United Kingdom, France, Australia and New Zealand. There is substantial international variation in regulatory policies and the extent to which these are enforced. Of the countries considered in this review, the US has regulations that remain the most permissive, whereas those in Canada and New Zealand are the most conservative. However, regulations in Canada, Australia and New Zealand are easily bypassed through Internet imports and lenient enforcement. European health agencies are paving the way for Member States to take appropriate steps to regulate e-cigarettes according to their own jurisdictions. Currently, national regulations of e-cigarettes appear to be ill-defined in terms of shaping the future of e-cigarette availability and use. National regulations should be strengthened to reflect the public health implications of e-cigarettes and to emphasize their difference from consumer products.

Coronary artery bypass graft surgery versus percutaneous coronary intervention with first-generation drug-eluting stents: a meta-analysis of randomized controlled trials.

OBJECTIVES: This study sought to compare the efficacy of coronary artery bypass graft surgery (CABG) to that of percutaneous coronary intervention (PCI) with first-generation drug-eluting stents among patients with multivessel disease (MVD), unprotected left main (LM) disease, and single-vessel proximal left anterior descending (LAD) disease. BACKGROUND: The efficacy and safety of CABG versus PCI with drug-eluting stents in patient subgroups remains controversial. METHODS: We systematically searched Cardiosource, Circulation, Clinicaltrials.gov, the Cochrane Library, EMBASE, and Medline for articles published through June 2013 for randomized controlled trials comparing CABG with PCI. Primary endpoints included mortality, myocardial infarction, revascularization, and stroke. Data were meta-analyzed with random-effects models. RESULTS: We identified 7 randomized controlled trials (N = 5,835): 2 of MVD (n = 2,410, 100% diabetic), 2 of LM disease (n = 1,206, 29.0% diabetic), 1 of 3-vessel or LM disease (n = 1,900, 25.5% diabetic), and 2 of single-vessel proximal LAD disease (n = 319, 36.3% diabetic). In MVD patients, CABG reduced the risk of mortality (risk ratio [RR]: 0.70, 95% confidence interval [CI]: 0.57 to 0.87), myocardial infarction (RR: 0.47, 95% CI: 0.36 to 0.61), and repeat revascularization (RR: 0.36, 95% CI: 0.24 to 0.52), but increased stroke risk (RR: 1.72, 95% CI: 1.02 to 2.90). In patients with LM disease, CABG reduced revascularization risk (RR: 0.60, 95% CI: 0.46 to 0.78) and increased stroke risk (RR: 2.89, 95% CI: 1.15 to 7.27). Data for patients with single-vessel proximal LAD disease were inconclusive. CONCLUSIONS: CABG is more efficacious than is PCI with first-generation drug-eluting stents in patients with LM and MVD, at the cost of increased rates of stroke. No conclusion can be drawn for patients with single-vessel proximal LAD disease.

The usefulness of ranolazine for the treatment of refractory chronic stable angina pectoris as determined from a systematic review of randomized controlled trials.

Despite the use of traditional antianginal medications (i.e., ß blockers, calcium channel blockers, and nitrates) and revascularization therapies, symptoms of chronic stable angina pectoris (CSAP) persist in ≥25% of patients. The objective of this systematic review was to synthesize the available evidence from randomized controlled trials (RCTs) of ranolazine for the treatment of CSAP. We systematically searched the Cochrane Register of Controlled Trials, EMBASE, and MEDLINE through July 2013 for RCTs comparing ranolazine with placebo or antianginal medications administered as part of usual care for the management of CSAP. End points of interest included exercise stress test performance (duration, time to angina, and time to ST-segment depression), frequency of angina attacks/week, nitroglycerin use/week, and quality of life. We identified 7 RCTs (n = 3,317) of patients with CSAP due to coronary artery disease. Comparators included placebo, amlodipine, and atenolol. All but 1 trial showed a statistically significant improvement in all 3 exercise stress test parameters with ranolazine compared with placebo. Ranolazine also reduced angina frequency and nitroglycerin use compared with placebo. These findings were consistent whether or not patients were also prescribed traditional antianginal pharmacotherapy. In conclusion, ranolazine reduces anginal symptoms among patients with symptomatic CSAP despite their use of traditional antianginal medications.

Agricultural subsidies and the American obesity epidemic.

Government-issued agricultural subsidies are worsening obesity trends in America. Current agricultural policy remains largely uninformed by public health discourse. Although findings suggest that eliminating all subsidies would have a mild impact on the prevalence of obesity, a revision of commodity programs could have a measurable public health impact on a population scale, over time. Policy reforms will be important determinants of the future of obesity in America, primarily through indemnity program revisions, and the allocation of increasing amounts of resources to sustainable agriculture. Public health intervention will be required at the policy level to promote healthy behavioral changes in consumers. The 2013 Farm Bill will be the key mechanism to induce such policy change in the near future.

Developing clinical skills using a virtual patient simulator in a resource-limited setting.

OBJECTIVE: to measure the effect of training with a virtual patient (VP) simulation system on clinical skills of healthcare professionals in Africa. METHODS: A randomized controlled intervention was carried out at Yaounde Central Hospital (Cameroon). The intervention consisted of two groups training on one of the two clinical vignettes implemented in the VP simulator. Four actors were trained to play standardized patient (SP) roles. The clinical skills (performance score) of participants were assessed on both clinical vignettes using these SPs. RESULTS: Twenty medical students from FMSB were recruited. The difference in overall score was observed between participants who received training from the VP system (higher average) and those who did not receive the training (lower average). This difference is statistically significant, especially when the focus is on participants' scores in the relevant items for proper management of the case. CONCLUSION: This study suggests that the training with a medical consultation VP simulator can develop the operational clinical skills of the user.