Strengthening the evidence base for mHealth in clinical practice: Conducting research with standalone or interoperable systems - a viewpoint.

Objective: The aim of this viewpoint is to inform mobile health (mHealth) evidence development in using standalone or interoperable systems in hospital practice. Methods: There is a gap between mHealth research and its widespread uptake in clinical practice. Evidence generation is not keeping up with the introduction and implementation of technologies. This is partly a consequence of the technology characteristics and the way research is conducted in a clinical setting. Research and development of mHealth technology can be conducted standalone in a laboratory like setting, standalone in a clinical setting or interoperable with already existing technology in hospital practice. Results: Standalone systems operate relatively independent from an organizations' existing infrastructure. Using laboratory settings does not reflect the complexity of real-life, but in clinical practice this may be suitable for research assessing usability, feasibility or even clinical and process outcomes at a small scale. Realizing research and development on interoperable mHealth technology solutions, especially with operational EMR systems, is a challenging, time- and resource intensive process and requires large(r) investments, as it is often complicated by a myriad of interfering factors. Interoperable systems are however a more sustainable option in the long run, and generated evidence reflects the real hospital care setting and this option may therefore facilitate dissemination. Choosing either a standalone or interoperable setting affects the research design, the implementation pace and ultimately widespread adoption of the mHealth technology. Conclusion: We recommend to include these technology characteristics in implementation frameworks and think of evaluation research designs in an early phase.

Remote continuous monitoring with wireless wearable sensors in clinical practice, nurses perspectives on factors affecting implementation: a qualitative study.

BACKGROUND: Continuous monitoring using wireless wearable sensors is a promising solution for use in clinical practice and in the home setting. It is important to involve nurses to ensure successful implementation. This paper aims to provide an overview of 1) factors affecting implementation of continuous monitoring using wireless wearable sensors by evaluating nurses' experiences with its use on the nursing ward, and 2) nurses' expectations for use in the home setting. METHODS: Semi-structured interviews were conducted with 16 nurses from three teaching hospitals in the Netherlands, covering constructs from the Consolidated Framework for Implementation Research (CFIR). A deductive approach of directed content analysis was applied. One additional factor was added using the Unified Theory for Acceptance of Technology (UTAUT). The quotes and domains were rated on valence (positive, neutral, negative) and strength (strong: - 2, + 2, neutral 0, and weak: - 1, + 1). RESULTS: Data was collected on 27 CFIR constructs and 1 UTAUT construct. In the experience of at least 8 nurses, five constructs had a strong positive influence on implementation on the nursing ward, including relative advantage (e.g., early detection of deterioration), patient needs and resources (e.g. feeling safe), networks and communications (e.g. execute tasks together), personal attributes (e.g. experience with intervention), and implementation leaders (e.g., project leader). Five constructs had a strong negative influence: evidence strength and quality (e.g. lack of evidence from practical experience), complexity (e.g. number of process steps), design quality and packaging (e.g., bad sensor quality), compatibility (e.g, change in work) and facilitating conditions (e.g, Wi-Fi connection). Nurses expected continuous monitoring in the home setting to be hindered by compatibility with work processes and to be facilitated by staff's access to information. Technical facilitating conditions (e.g. interoperability) were suggested to be beneficial for further development. CONCLUSIONS: This paper provides an overview, of factors influencing implementation of continuous monitoring including relative importance, based on nurses' experiences with use on nursing wards, and their perspectives for use in the home setting. Implementation of continuous monitoring is affected by a wide range of factors. This overview may be used as a guideline for future implementations.

The Effect of Telehealth on Hospital Services Use: Systematic Review and Meta-analysis.

BACKGROUND: Telehealth interventions, that is, health care provided over a distance using information and communication technology, are suggested as a solution to rising health care costs by reducing hospital service use. However, the extent to which this is possible is unclear. OBJECTIVE: The aim of this study is to evaluate the effect of telehealth on the use of hospital services, that is, (duration of) hospitalizations, and to compare the effects between telehealth types and health conditions. METHODS: We searched PubMed, Scopus, and the Cochrane Library from inception until April 2019. Peer-reviewed randomized controlled trials (RCTs) reporting the effect of telehealth interventions on hospital service use compared with usual care were included. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool and quality of evidence according to the Grading of Recommendations Assessment, Development and Evaluation guidelines. RESULTS: We included 127 RCTs in the meta-analysis. Of these RCTs, 82.7% (105/127) had a low risk of bias or some concerns overall. High-quality evidence shows that telehealth reduces the risk of all-cause or condition-related hospitalization by 18 (95% CI 0-30) and 37 (95% CI 20-60) per 1000 patients, respectively. We found high-quality evidence that telehealth leads to reductions in the mean all-cause and condition-related hospitalizations, with 50 and 110 fewer hospitalizations per 1000 patients, respectively. Overall, the all-cause hospital days decreased by 1.07 (95% CI -1.76 to -0.39) days per patient. For hospitalized patients, the mean hospital stay for condition-related hospitalizations decreased by 0.89 (95% CI -1.42 to -0.36) days. The effects were similar between telehealth types and health conditions. A trend was observed for studies with longer follow-up periods yielding larger effects. CONCLUSIONS: Small to moderate reductions in hospital service use can be achieved using telehealth. It should be noted that, despite the large number of included studies, uncertainties around the magnitude of effects remain, and not all effects are statistically significant.

Video Consultation as an Adequate Alternative to Face-to-Face Consultation in Continuous Positive Airway Pressure Use for Newly Diagnosed Patients With Obstructive Sleep Apnea: Randomized Controlled Trial.

BACKGROUND: The effectiveness of continuous positive airway pressure (CPAP) is dependent on the degree of use, so adherence is essential. Cognitive components (eg, self-efficacy) and support during treatment have been found to be important in CPAP use. Video consultation may be useful to support patients during treatment. So far, video consultation has rarely been evaluated in thorough controlled research, with only a limited number of outcomes assessed. OBJECTIVE: The aim of the study was to evaluate the superiority of video consultation over face-to-face consultation for patients with obstructive sleep apnea (OSA) on CPAP use (minutes per night), adherence, self-efficacy, risk outcomes, outcome expectancies, expectations and experiences with video consultation, and satisfaction of patients and nurses. METHODS: A randomized controlled trial was conducted with an intervention (video consultation) and a usual care group (face-to-face consultation). Patients with confirmed OSA (apnea-hypopnea index >15), requiring CPAP treatment, no history of CPAP treatment, having access to a tablet or smartphone, and proficient in the Dutch language were recruited from a large teaching hospital. CPAP use was monitored remotely, with short-term (weeks 1 to 4) and long-term (week 4, week 12, and week 24) assessments. Questionnaires were completed at baseline and after 4 weeks on self-efficacy, risk perception, outcome expectancies (Self-Efficacy Measure for Sleep Apnea), expectations and experiences with video consultation (covering constructs of the unified theory of acceptance and use of technology), and satisfaction. Nurse satisfaction was evaluated using questionnaires. RESULTS: A total of 140 patients were randomized (1:1 allocation). The use of video consultation for OSA patients does not lead to superior results on CPAP use and adherence compared with face-to-face consultation. A significant difference in change over time was found between groups for short-term (P-interaction=.008) but not long-term (P-interaction=.68) CPAP use. CPAP use decreased in the long term (P=.008), but no significant difference was found between groups (P=.09). Change over time for adherence was not significantly different in the short term (P-interaction=.17) or long term (P-interaction=.51). A relation was found between CPAP use and self-efficacy (P=.001), regardless of the intervention arm (P=.25). No significant difference between groups was found for outcome expectancies (P=.64), self-efficacy (P=.41), and risk perception (P=.30). The experiences were positive, and 95% (60/63) intended to keep using video consultation. Patients in both groups rated the consultations on average with an 8.4. Overall, nurses (n=3) were satisfied with the video consultation system. CONCLUSIONS: Support of OSA patients with video consultation does not lead to superior results on CPAP use and adherence compared with face-to-face consultation. The findings of this research suggest that self-efficacy is an important factor in improving CPAP use and that video consultation may be a feasible way to support patients starting CPAP. Future research should focus on blended care approaches in which self-efficacy receives greater emphasis. TRIAL REGISTRATION: Clinicaltrials.gov NCT04563169; https://clinicaltrials.gov/show/NCT04563169.

Effectiveness of a Mobile Health and Self-Management App for High-Risk Patients With Chronic Obstructive Pulmonary Disease in Daily Clinical Practice: Mixed Methods Evaluation Study.

BACKGROUND: Mobile health and self-management interventions may positively affect behavioral change and reduce hospital admissions for patients with chronic obstructive pulmonary disease (COPD). However, not all patients qualify for these interventions, and systematic, comprehensive information on implementation- and compliance-related aspects of mobile self-management apps is lacking. Due to the tendency to target digital services to patients in stable phases of disease, it is especially relevant to focus on the use of these services in broad clinical practice for patients recently discharged from hospital. OBJECTIVE: This study aims to evaluate the effects of a mobile health and self-management app in clinical practice for recently discharged patients with COPD on use of the app, self-management, expectations, and experiences (technology acceptance); patients' and nurses' satisfaction; and hospital readmissions. METHODS: A prototype of the app was pilot tested with 6 patients with COPD. The COPD app consisted of an 8-week program including the Lung Attack Action Plan, education, medication overview, video consultation, and questionnaires (monitored by nurses). In the feasibility study, adult patients with physician-diagnosed COPD, access to a mobile device, and proficiency of the Dutch language were included from a large teaching hospital during hospital admission. Self-management (Partners in Health Scale), technology acceptance (Unified Theory Acceptance and Use of Technology model), and satisfaction were assessed using questionnaires at baseline, after 8 weeks, and 20 weeks. Use was assessed with log data, and readmission rates were extracted from the electronic medical record. RESULTS: A total of 39 patients were included; 76.4% (133/174) of patients had to be excluded from participation, and 48.9% of those patients (65/133) were excluded because of lack of digital skills, access to a mobile device, or access to the internet. The COPD app was opened most often in the first week (median 6.0; IQR 3.5-10.0), but its use decreased over time. The self-management element knowledge and coping increased significantly over time (P=.04). The COPD app was rated on a scale of 1-10, with an average score by patients of 7.7 (SD 1.7) and by nurses of 6.3 (SD 1.2). Preliminary evidence about the readmission rate showed that 13% (5/39) of patients were readmitted within 30 days; 31% (12/39) of patients were readmitted within 20 weeks, compared with 14.1% (48/340) and 21.8% (74/340) in a preresearch cohort, respectively. CONCLUSIONS: The use of a mobile self-management app after hospital discharge seems to be feasible only for a small number of patients with COPD. Patients were satisfied with the service; however, use decreased over time, and only knowledge and coping changed significantly over time. Therefore, future research on digital self-management interventions in clinical practice should focus on including more difficult subgroups of target populations, a multidisciplinary approach, technology-related aspects (such as acceptability), and fine-tuning its adoption in clinical pathways. TRIAL REGISTRATION: Clinicaltrials.gov NCT04540562; https://clinicaltrials.gov/ct2/show/NCT04540562.

Combining Radiation Therapy With Interferons: Back to the Future.

Radiation therapy has been linked to the induction of an intratumoral type I interferon (IFN) response, which positively affects the response to treatment. This has spiked the interest to combine radiation therapy with IFN-based treatment. Interestingly, this combination treatment has been considered previously, since preclinical studies demonstrated a radiosensitizing effect of interferons. As a result, multiple clinical trials have been performed combining radiation therapy with interferons in different tumor types. Although potential benefit has been suggested, the outcomes of the trials are diverse and challenging to interpret. In addition, increased grade ≥3 toxicity frequently resulted in a negative recommendation regarding the combination therapy. The latter appears premature because many studies were small and several aspects of the combination treatment have not yet been sufficiently explored to justify such a definite conclusion. This review summarizes the available literature on this combination therapy, with a focus on IFN-α and IFN-ß. Based on preclinical studies and clinical trials, we evaluated the potential opportunities and describe the current challenges. In addition, we identify several issues that should be addressed to fully exploit the potential benefit of this combinatorial treatment approach.

Barriers and Facilitators Affecting Patient Portal Implementation from an Organizational Perspective: Qualitative Study.

BACKGROUND: The number of patient portals is rising, and although portals can have positive effects, their implementation has major impacts on the providing health care institutions. However, little is known about the organizational factors affecting successful implementation. Knowledge of the specific barriers to and facilitators of various stakeholders is likely to be useful for future implementations. OBJECTIVE: The objective of this study was to identify the barriers to and facilitators of patient portal implementation facing various stakeholders within hospital organizations in the Netherlands. METHODS: Purposive sampling was used to select hospitals of various types. A total of 2 university medical centers, 3 teaching hospitals, and 2 general hospitals were included. For each, 3 stakeholders were interviewed: (1) medical professionals, (2) managers, and (3) information technology employees. In total, 21 semistructured interviews were conducted using the Grol and Wensing model, which describes barriers to and facilitators of change in health care practice at 6 levels: (1) innovation; (2) individual professional; (3) patient; (4) social context; (5) organizational context; and (6) economic and political context. Two researchers independently selected and coded quotes by applying this model using a (deductive) directed content approach. Additional factors related to technical and portal characteristics were added using the model of McGinn et al, developed for implementation of electronic health records. RESULTS: In total, we identified 376 quotes, 26 barriers, and 28 facilitators. Thirteen barriers and 12 facilitators were common for all stakeholder groups. The facilitators' perceived usefulness (especially less paperwork) was mentioned by all the stakeholders, followed by subjects' positive attitude. The main barriers were lack of resources (namely, lack of staff and materials), financial difficulties (especially complying with high costs, lack of reimbursements), and guaranteeing privacy and security (eg, strict regulations). Both similarities and differences were found between stakeholder groups and hospital types. For example, managers and information technology employees mainly considered guaranteeing privacy and security as a predominant barrier. Financial difficulties were particularly mentioned by medical professionals and managers. CONCLUSIONS: Patient portal implementation is a complex process and is not only a technical process but also affects the organization and its staff. Barriers and facilitators occurred at various levels and differed among hospital types (eg, lack of accessibility) and stakeholder groups (eg, sufficient resources) in terms of several factors. Our findings underscore the importance of involving multiple stakeholders in portal implementations. We identified a set of barriers and facilitators that are likely to be useful in making strategic and efficient implementation plans.

The Effectiveness of Information Technology-Supported Shared Care for Patients With Chronic Disease: A Systematic Review.

BACKGROUND: In patients with chronic disease, many health care professionals are involved during treatment and follow-up. This leads to fragmentation that in turn may lead to suboptimal care. Shared care is a means to improve the integration of care delivered by various providers, specifically primary care physicians (PCPs) and specialty care professionals, for patients with chronic disease. The use of information technology (IT) in this field seems promising. OBJECTIVE: Our aim was to systematically review the literature regarding the effectiveness of IT-supported shared care interventions in chronic disease in terms of provider or professional, process, health or clinical and financial outcomes. Additionally, our aim was to provide an inventory of the IT applications' characteristics that support such interventions. METHODS: PubMed, Scopus, and EMBASE were searched from 2006 to 2015 to identify relevant studies using search terms related to shared care, chronic disease, and IT. Eligible studies were in the English language, and the randomized controlled trials (RCTs), controlled trials, or single group pre-post studies used reported on the effects of IT-supported shared care in patients with chronic disease and cancer. The interventions had to involve providers from both primary and specialty health care. Intervention and IT characteristics and effectiveness-in terms of provider or professional (proximal), process (intermediate), health or clinical and financial (distal) outcomes-were extracted. Risk of bias of (cluster) RCTs was assessed using the Cochrane tool. RESULTS: The initial search yielded 4167 results. Thirteen publications were used, including 11 (cluster) RCTs, a controlled trial, and a pre-post feasibility study. Four main categories of IT applications were identified: (1) electronic decision support tools, (2) electronic platform with a call-center, (3) electronic health records, and (4) electronic communication applications. Positive effects were found for decision support-based interventions on financial and health outcomes, such as physical activity. Electronic health record use improved PCP visits and reduced rehospitalization. Electronic platform use resulted in fewer readmissions and better clinical outcomes-for example, in terms of body mass index (BMI) and dyspnea. The use of electronic communication applications using text-based information transfer between professionals had a positive effect on the number of PCPs contacting hospitals, PCPs' satisfaction, and confidence. CONCLUSIONS: IT-supported shared care can improve proximal outcomes, such as confidence and satisfaction of PCPs, especially in using electronic communication applications. Positive effects on intermediate and distal outcomes were also reported but were mixed. Surprisingly, few studies were found that substantiated these anticipated benefits. Studies showed a large heterogeneity in the included populations, outcome measures, and IT applications used. Therefore, a firm conclusion cannot be drawn. As IT applications are developed and implemented rapidly, evidence is needed to test the specific added value of IT in shared care interventions. This is expected to require innovative research methods.