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BACKGROUND AND AIMS: In patients with chronic heart failure (HF), the MONITOR-HF trial demonstrated the efficacy of pulmonary artery (PA)-guided HF therapy over standard of care in improving quality of life and reducing HF hospitalizations and mean PA pressure. This study aimed to evaluate the consistency of these benefits in relation to clinically relevant subgroups. METHODS: The effect of PA-guided HF therapy was evaluated in the MONITOR-HF trial among predefined subgroups based on age, sex, atrial fibrillation, diabetes mellitus, left ventricular ejection fraction, HF aetiology, cardiac resynchronization therapy, and implantable cardioverter defibrillator. Outcome measures were based upon significance in the main trial and included quality of life-, clinical-, and PA pressure endpoints, and were assessed for each subgroup. Differential effects in relation to the subgroups were assessed with interaction terms. Both unadjusted and multiple testing adjusted interaction terms were presented. RESULTS: The effects of PA monitoring on quality of life, clinical events, and PA pressure were consistent in the predefined subgroups, without any clinically relevant heterogeneity within or across all endpoint categories (all adjusted interaction P-values were non-significant). In the unadjusted analysis of the primary endpoint quality-of-life change, weak trends towards a less pronounced effect in older patients (Pinteraction = .03; adjusted Pinteraction = .33) and diabetics (Pinteraction = .01; adjusted Pinteraction = .06) were observed. However, these interaction effects did not persist after adjusting for multiple testing. CONCLUSIONS: This subgroup analysis confirmed the consistent benefits of PA-guided HF therapy observed in the MONITOR-HF trial across clinically relevant subgroups, highlighting its efficacy in improving quality of life, clinical, and PA pressure endpoints in chronic HF patients.
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Insuficiencia Cardíaca , Arteria Pulmonar , Calidad de Vida , Humanos , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/fisiopatología , Femenino , Masculino , Anciano , Persona de Mediana Edad , Arteria Pulmonar/fisiopatología , Enfermedad Crónica , Volumen Sistólico/fisiología , Terapia de Resincronización Cardíaca/métodos , Desfibriladores ImplantablesRESUMEN
BACKGROUND: Access to timely and accurate diagnostic imaging is essential for high-quality healthcare. Point-of-care ultrasound has been shown to be accessible and effective in many aspects of healthcare, including assessing changes in lung pathology. However, few studies have examined self-administered at-home lung ultrasound (SAAH-LUS), in particular performed by non-clinical patients (NCPs). RESEARCH QUESTION: Are NCPs able to perform SAAH-LUS using remote teleguidance and produce interpretable images? STUDY DESIGN: Patients were enrolled to the study in a mix of in-person and virtual recruitment, and shipped a smartphone as well as a point of care ultrasound device. Tele-guidance was provided by a remote physician using software integrated with the point of care ultrasound device, allowing real-time remote visualization and guidance of a patient scanning their own chest. A post-intervention survey was conducted to assess patient satisfaction, feasibility, and acceptability of SAAH-LUS. Two POCUS expert reviewers reviewed the scans for interpretability, and inter-rater agreement between the two reviewers was also computed. RESULTS: Eighteen patients successfully underwent 7-14 days of daily telemedicine in parallel to daily SAAH-LUS. Across 1339 scans obtained from ten different lung zones, the average proportion of interpretability was 96% with a chance-corrected agreement, or Cohen's kappa, reported as κ = 0.67 (significant agreement). 100% of NCPs surveyed found SAAH-LUS to be a positive experience, particularly for its ease of operation and ability to increase access to healthcare services. INTERPRETATION: This study demonstrates that NCPs can obtain interpretable LUS images at home, highlighting the potential for SAAH-LUS to increase diagnostic capacity, particularly for rural and remote regions where complex imaging and healthcare providers are difficult to obtain. Trial registration The clinical trials has been registered (clinicaltrials.gov). REGISTRATION NUMBER: NCT04967729.
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Personal de Salud , Tórax , Humanos , Pulmón/diagnóstico por imagen , Satisfacción del Paciente , UltrasonografíaRESUMEN
OBJECTIVE: To evaluate the effectiveness of integrated personalized diabetes management (iPDM) through telemedicine (tele-iPDM) with regard to glycaemic control. METHODS: A 6-month single-centre, open-label, prospective randomized controlled trial enrolled insulin-treated patients with type 2 diabetes, aged 18-65 years with glycated haemoglobin (HbA1c) levels of 7.5%-10.5%. The tele-iPDM group received insulin adjustment by investigators through a cloud-based telemonitoring platform for 6 months (blood glucose monitoring reviewed weekly from Weeks 0 to 12 and then monthly from Weeks 13 to 24). The control group performed self-monitoring and insulin adjustment. The primary outcome was the difference in HbA1c change from baseline between the two groups at 24 weeks. Secondary outcomes included changes in HbA1c at 12 weeks, fasting plasma glucose, body weight, body mass index (BMI), the percentage of individuals achieving HbA1c <7% at 24 weeks, the percentage of individuals with an HbA1c reduction of >0.5% at 24 weeks, and incidences of hypoglycaemic events. RESULTS: A total of 151 participants were enrolled, with a mean age of 53.36 ± 8.08 years and a mean diabetes duration of 12.38 ± 8.47 years. The baseline HbA1c was 8.47 ± 0.76%. The mean HbA1c decreased from baseline to 12 and 24 weeks in both groups. At 12 weeks, HbA1c reduction from baseline was -1.2% (95%CI -1.42 to -0.98) in the tele-iPDM group and -0.57% (95%CI -0.79 to -0.36) in the control group. The mean difference in HbA1c between the tele-iPDM and usual care groups at 12 weeks was -0.63% (95%CI -0.94 to -0.32; p < 0.001). At 24 weeks, HbA1c reduction from baseline was -1.14% (95%CI -1.38 to -0.89) in the tele-iPDM group and - 0.49% (95%CI -0.73 to -0.25) in the control group. The mean difference in HbA1c between the tele-iPDM and usual care groups was -0.65% (95%CI -0.99 to -0.30; p < 0.001). There were no significant differences in body weight, BMI, or hypoglycaemic events between the two groups. CONCLUSION: Telemonitoring can support the iPDM care model in individuals with insulin-treated type 2 diabetes. It improves the efficiency of diabetes care, enhances glycaemic control at 12 weeks, and sustains glycaemic control at 24 weeks.
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Automonitorización de la Glucosa Sanguínea , Diabetes Mellitus Tipo 2 , Hemoglobina Glucada , Hipoglucemiantes , Insulina , Medicina de Precisión , Telemedicina , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/complicaciones , Persona de Mediana Edad , Masculino , Femenino , Adulto , Insulina/uso terapéutico , Hemoglobina Glucada/análisis , Hemoglobina Glucada/metabolismo , Hipoglucemiantes/uso terapéutico , Automonitorización de la Glucosa Sanguínea/métodos , Medicina de Precisión/métodos , Anciano , Estudios Prospectivos , Glucemia/metabolismo , Glucemia/análisis , Control Glucémico/métodos , Resultado del Tratamiento , Hipoglucemia/prevención & control , Hipoglucemia/inducido químicamente , Adolescente , Adulto Joven , Índice de Masa CorporalRESUMEN
The dosing of tacrolimus, which forms the backbone of immunosuppressive therapy after kidney transplantation, is complex. This is due to its variable pharmacokinetics (both between and within individual patients), narrow therapeutic index, and the severe consequences of over- and underexposure, which may cause toxicity and rejection, respectively. Tacrolimus is, therefore, routinely dosed by means of therapeutic drug monitoring (TDM). TDM is performed for as long as the transplant functions and frequent and often lifelong sampling is therefore the rule. This puts a significant burden on patients and transplant professionals and is associated with high healthcare-associated costs. Furthermore, by its very nature, TDM is reactive and has no predictive power. Finally, the current practice of TDM does not foresee in an active role for patients themselves. Rather, the physician or pharmacist prescribes the next tacrolimus dose after obtaining the concentration measurement test results. In this article, we propose a strategy of patient-controlled, home-based, self-TDM of the immunosuppressant tacrolimus after transplantation. We argue that with the combined use of population tacrolimus pharmacokinetic models, home-based sampling by means of dried blood spotting and implementation of telemedicine, this may become a feasible approach in the near future.
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One of the main challenges in weight loss programs is compliance with diet and achievement of sustainable changes in eating habits and lifestyles. Most clients desire to lose weight quickly, rather than looking at long-term changes. The literature suggests applying telenutrition, owing to its convenience and easy access in combination with both telemonitoring and health coaching, where confounding factors in the diet are tackled. A 6-month randomised controlled trial will be conducted to compare the effectiveness of Telenutrition Versus Telenutrition supported by weekly telemonitoring and monthly health coaching in a weight loss program. Participants are obese and overweight adults of both sex groups, aged 20-50 years who will be randomized to join a control or an intervention group. A total of three visits will be scheduled for all participants: at baseline, after three months, and after six months. This study aims to answer the question of whether participants following a weight loss program supported by telemonitoring and health coaching will increase their weight loss and compliance to the diet in comparison with the control group. This will be the first trial to assess the impact of integrating telemonitoring and health coaching in weight loss programs, including the evaluation of associated confounding factors such as general nutrition education, eating behaviour, Sensory modalities and hunger, and stress. This trial will support dietary weight loss programs, contribute to the emerging field of telenutrition, and provide advice for clinical dietitians and health coaches to work together to help individuals lose and maintain weight.
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AIMS: In the current guidelines, smartphone photoplethysmography (PPG) is not recommended for diagnosis of atrial fibrillation (AF), without a confirmatory electrocardiogram (ECG) recording. Previous validation studies have been performed under supervision in healthcare settings, with limited generalizability of the results. We aim to investigate the diagnostic performance of a smartphone-PPG method in a real-world setting, with ambulatory unsupervised smartphone-PPG recordings, compared with simultaneous ECG recordings and including patients with atrial flutter (AFL). METHODS AND RESULTS: Unselected patients undergoing direct current cardioversion for treatment of AF or AFL were asked to perform 1-min heart rhythm recordings post-treatment, at least twice daily for 30 days at home, using an iPhone 7 smartphone running the CORAI Heart Monitor PPG application simultaneously with a single-lead ECG recording (KardiaMobile). Photoplethysmography and ECG recordings were read independently by two experienced readers. In total, 280 patients recorded 18 005 simultaneous PPG and ECG recordings. Sufficient quality for diagnosis was seen in 96.9% (PPG) vs. 95.1% (ECG) of the recordings (P < 0.001). Manual reading of the PPG recordings, compared with manually interpreted ECG recordings, had a sensitivity, specificity, and overall accuracy of 97.7%, 99.4%, and 98.9% with AFL recordings included and 99.0%, 99.7%, and 99.5%, respectively, with AFL recordings excluded. CONCLUSION: A novel smartphone-PPG method can be used by patients unsupervised at home to achieve accurate heart rhythm diagnostics of AF and AFL with very high sensitivity and specificity. This smartphone-PPG device can be used as an independent heart rhythm diagnostic device following cardioversion, without the requirement of confirmation with ECG.
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Fibrilación Atrial , Aleteo Atrial , Humanos , Teléfono Inteligente , Fibrilación Atrial/diagnóstico , Electrocardiografía/métodos , Aleteo Atrial/diagnóstico , Cardioversión Eléctrica , FotopletismografíaRESUMEN
BACKGROUND: Monitoring and managing asthma using technology can help increase patient adherence and achieve better asthma control. This study aimed to evaluate the effectiveness of telemonitoring using smartphones and telephone communication compared to usual outpatient clinical evaluation in patients with asthma. DATA SOURCES: This systematic review was conducted in 2023. Databases PubMed, Scopus, Web of Science, and the Google Scholar search engine, were searched from 2013 to 2022. DATA SELECTION: The selected studies were randomized clinical trials that used telemonitoring in patients with asthma. The quality of the studies was evaluated using the JADAD scale. Data were collected using a data extraction form, and the findings were synthesized narratively. This systematic review was conducted following the PRISMA checklist. RESULTS: Initially, 4,147 articles were found, of which 14 were included in the study. The results showed that in some cases, telemonitoring using smartphones and telephone communication in patients with asthma is effective, while in other studies, its effectiveness was not observed. CONCLUSIONS: Telemonitoring using smartphones and telephone communication in patients with asthma can be considered an appropriate strategy to reduce the use of healthcare resources and improve quality of life. However, further studies are recommended to investigate the effectiveness of each of these technologies and their specific outcomes.
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Asma , Telemedicina , Humanos , Asma/tratamiento farmacológico , Asma/terapia , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , TeléfonoRESUMEN
Lay people are now able to obtain one-lead electrocardiograms (ECG) using smartwatches, which facilitates documentation of arrhythmias. The accuracy of smartwatch derived ECG intervals has not been validated in children though. Home-based monitoring of ECG intervals using a smartwatch could improve monitoring of children, e.g. when taking QTc prolonging medications. The aim of this study was to validate the ECG intervals measured by smartwatch in comparison to standard 12-lead ECGs in children and adolescents. Prospective study of children (age 5-17 years) at the outpatient clinic of a national pediatric heart center. Patients underwent a smartwatch ECG (ScanWatch, Withings) and a simultaneous standard 12-lead ECG. ECG intervals were measured both automatically and manually from the smartwatch ECG and the 12-lead ECG. Intraclass correlation coefficients and Bland-Altman plots were performed. 100 patients (54% male, median age 12.9 (IQR 8.7-15.6) were enrolled. The ICC calculated from the automated smartwatch and automated 12-lead ECG were excellent for heart rate (ICC 0.97, p < 0.001), good for the PR and QT intervals (ICC 0.86 and 0.8, p < 0.001), and moderate for the QRS duration and QTc interval (ICC 0.7 and 0.53, p < 0.001). When using manual measurements for the smartwatch ECG, validity was improved for the PR interval (ICC 0.93, p < 0.001), QRS duration (ICC 0.92, p < 0.001), QT (ICC 0.95, p < 0.001) and QTc interval (ICC 0.84, p < 0.001). CONCLUSION: Automated smartwatch intervals are most reliable measuring the heart rate. The automated smartwatch QTc intervals are less reliable, but this may be improved by manual measurements. WHAT IS KNOWN: In adults, smartwatch derived ECG intervals measured manually have previously been shown to be accurate, though agreement for automated QTc may be fair. WHAT IS NEW: In children, automated smartwatch QTc intervals are less reliable than RR, PR, QRS and uncorrected QT interval. Accuracy of the QTc can be improved by peroforming manual measurements.
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Arritmias Cardíacas , Electrocardiografía , Humanos , Niño , Masculino , Femenino , Estudios Prospectivos , Adolescente , Preescolar , Arritmias Cardíacas/diagnóstico , Electrocardiografía/instrumentación , Electrocardiografía/métodos , Frecuencia Cardíaca/fisiología , Reproducibilidad de los Resultados , Electrocardiografía Ambulatoria/instrumentación , Electrocardiografía Ambulatoria/métodos , Dispositivos Electrónicos VestiblesRESUMEN
PURPOSE : Continuous positive airway pressure (CPAP) is often the treatment of choice for obstructive sleep apnea (OSA). Short-term adherence and early perceived benefits are the best predictors of long-term adherence. The aim of this study was to determine the effect of telemonitoring in the first period of treatment with CPAP (auto-titrating PAP) on compliance and the long-term outcome. METHODS: Patients aged between 18-75 years old with symptomatic severe OSA (apnea-hypopnea index (AHI) ≥ 30) requiring CPAP therapy were included in this single-blind, single-centre, randomised, controlled trial. They were divided into 2 groups (telemonitored standard clinical care versus standard clinical care without telemonitoring). RESULTS: A total of 230 patients (115 patients/group) were included (mean age 54 ± 16.6 years, BMI 32.6 ± 5.4 kg/m2, ESS 13.1 ± 6.2, AHI 47.5 ± 14.8/hr). At week 10 compliance was similar in both groups (telemonitoring vs control 6:27 and 6:35 h, respectively, p = 0.57), as were AHI (2.4; 2.4/hr, p = 0.89) and ESS (5.8; 4.9, p = 0.22). The number of contacts of a patient with a healthcare professional was significantly higher during the follow-up from week 3 until week 10 (0.25; 0.13, p = 0.03). The number of patients who could be evaluated after 1 year was equally distributed in both groups (104; 104, p = 1.00), as were compliance (6:43; 6:49 h, p = 0.59) and residual AHI (1.9; 2.2/hr, p = 0.41). CONCLUSIONS: In patients with severe OSA with standard intensive follow-up during the initial weeks of CPAP therapy and good compliance, telemonitoring did not improve CPAP compliance nor the clinical outcome in the short or long term. The practical consequences can be highly relevant for patients and healthcare professionals.
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Presión de las Vías Aéreas Positiva Contínua , Cooperación del Paciente , Apnea Obstructiva del Sueño , Humanos , Persona de Mediana Edad , Apnea Obstructiva del Sueño/terapia , Masculino , Femenino , Adulto , Anciano , Método Simple Ciego , TelemedicinaRESUMEN
PURPOSE: To develop and evaluate an intervention tailored to patients' needs to increase the rate of positive airway pressure (PAP) adherence in patients afflicted with obstructive sleep apnea (OSA), who undergo PAP therapy. METHODS: A multi-center, 3 parallel-arm, randomized, controlled trial was conducted. Participants with OSA who undergo a PAP therapy were randomized to one of three groups: control arm (usual care), educational booklet arm, and mobile-based application arm. PAP usage, the percentage of days using the device for more than 4 h, change in knowledge, risk perception, outcome expectancy, self-efficacy, and ESS were assessed before and one month after interventions in the three groups. Also, the application usage data were analyzed. RESULTS: The result showed the change in average PAP usage, knowledge, risk perception, and self-efficacy in the application group was significantly higher than the control and booklet groups. Also, the change in use for more than 4 h in the application group was significantly higher than the control group. Comparing the actual and patients' self-report PAP use indicated patients' self-report about the use of the device is about 50 min (0.8 h) more than the actual amount of use. CONCLUSION: The study results indicated that the improvement of primary and secondary outcomes in adherence to PAP was significantly higher in the application group than in other study groups. Given the increasingly penetrating influence of smartphone-based technologies, it seems that mobile-based applications could potentially be adopted in the population of patients with OSA. CLINICAL TRIALS REGISTRATION: IRCT2017092236314N1; https://en.irct.ir/trial/27185.
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BACKGROUND: Medication non-adherence is a significant problem in patients with Chronic Obstructive Pulmonary Disease (COPD). Efforts to address this issue are receiving increased attention. Simplifying treatment by prescribing single-inhaler triple therapy (SITT) as an alternative to multi-inhaler triple therapy (MITT) or with smart inhalers are often considered potential solutions. However, the actual impact of these innovations on adherence and clinical outcomes is unclear. METHODS: To address this knowledge gap we first conducted a literature review focusing on two research questions: 1) the difference in adherence between SITT and MITT users in COPD, and 2) the effect of smart inhalers on adherence in COPD. Separate searches were conducted in PubMed and two authors independently assessed the articles. In addition, we present a protocol for a study to acquire knowledge for the gaps identified. RESULTS: To address the first research question, 8 trials were selected for further review. All trials were observational, i.e. randomized controlled trials were lacking. Seven of these trials showed higher adherence and/or persistence in patients on SITT compared with patients on MITT. In addition, four studies showed a positive effect of SITT on various clinical outcomes. For the second research question, 11 trials were selected for review. While most of the studies showed a positive effect of smart inhalers on adherence, there was considerable variation in the results regarding their effect on other clinical outcomes. The TRICOLON (TRIple therapy COnvenience by the use of one or multipLe Inhalers and digital support in ChrONic Obstructive Pulmonary Disease) trial aims to improve understanding regarding the effectiveness of SITT and smart inhalers in enhancing adherence. This open-label, randomized, multi-center study will enroll COPD patients requiring triple therapy at ten participating hospitals. In total, 300 patients will be randomized into three groups: 1) MITT; 2) SITT; 3) SITT with digital support through a smart inhaler and an e-health platform. The follow-up period will be one year, during which three methods of measuring adherence will be used: smart inhaler data, self-reported data using the Test of Adherence to Inhalers (TAI) questionnaire, and drug analysis in scalp hair samples. Finally, differences in clinical outcomes between the study groups will be compared. DISCUSSION: Our review suggests promising results concerning the effect of SITT, as opposed to MITT, and smart inhalers on adherence. However, the quality of evidence is limited due to the absence of randomized controlled trials and/or the short duration of follow-up in many studies. Moreover, its impact on clinical outcomes shows considerable variation. The TRICOLON trial aims to provide solid data on these frequently mentioned solutions to non-adherence in COPD. Collecting data in a well-designed randomized controlled trial is challenging, but the design of this trial addresses both the usefulness of SITT and smart inhalers while ensuring minimal interference in participants' daily lives. TRIAL REGISTRATION: NCT05495698 (Clinicaltrials.gov), registered at 08-08-2022. Protocol version: version 5, date 27-02-2023.
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Cumplimiento de la Medicación , Nebulizadores y Vaporizadores , Enfermedad Pulmonar Obstructiva Crónica , Enfermedad Pulmonar Obstructiva Crónica/tratamiento farmacológico , Humanos , Administración por Inhalación , Broncodilatadores/administración & dosificación , Ensayos Clínicos Controlados Aleatorios como Asunto , Quimioterapia CombinadaRESUMEN
BACKGROUND: Asthma is one of the most common respiratory ailments worldwide. Despite broad understanding of the illness and of the available therapeutic options for it, patients with serious asthma suffer poor monitoring of their illness in 50% of cases. AIM: To assess the impact of the implementation of a mobile application (ESTOI) to control asthma in patients diagnosed with the illness, their adherence to treatment, and their perceived quality of life. METHODOLOGY: Randomized clinical trial with 52 weeks' follow-up of patients with asthma seen in a specialized hospital for their treatment in Spain. Some 108 included patients will be divided into two groups. The intervention group will undergo more exhaustive follow-up than normal, including access to the ESTOI application, which will have various categories of attention: control of symptoms, health recommendations, current treatment and personalized action plan, PEF record, nutritional plan, and chat access with a medical team. The asthma control questionnaire ACT is the main assessment variable. Other variables to be studied include an adherence test for the use of inhalers (TAI), the number of exacerbations, maximum exhalation flow, exhaled nitric oxide test, hospital anxiety and depression scale, asthma quality-of-life questionnaire, forced spirometry parameters (FVC, FEV1, and PBD), and analytic parameters (eosinophilia and IGE). The data will be collected during outpatient visits. TRIAL REGISTRATION: This trial has registered at ClinicalTrials.gov (Identifier: NCT06116292).
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Asma , Telemedicina , Humanos , Calidad de Vida , Asma/diagnóstico , Asma/tratamiento farmacológico , Nebulizadores y Vaporizadores , EspirometríaRESUMEN
INTRODUCTION: Demands for myopia management are rising. A web-based tool that allows home-performed self-assessments of visual acuity (VA) and refractive error may enable hybrid care pathways and aid in identifying those with deteriorating visual performance. The tool has been validated in adult populations, but has yet to be evaluated in children. This study compared home-performed VA and refraction self-assessments to conventional measurements obtained at the clinic in a population of myopic children. METHODS: Myopic children aged ≥6 years old were invited to perform web-based eye tests at home, assisted by a parent. At two myopia control clinics, they also underwent measurements of VA using a Snellen chart and refractive error using cycloplegic autorefraction. Agreement between the tests, repeatability of the web-based test and associations between clinical characteristics and web-based test accuracy were evaluated. RESULTS: A total of 147 children were enrolled, of whom 116 (51% male; mean age 13 ± 3 years; mean spherical equivalent refraction (SEQ) -5.58 ± 3.05) performed the web-based tests at home. Overall, the home-performed VA self-assessment and the Snellen chart assessment at the clinic agreed well (mean difference 0.03 ± 0.11 logMAR). A significant proportional bias was identified (ß 0.65, p < 0.001), indicating underestimated web-based VA scores when the child's vision declined. The sensitivity to detect VA poorer than 0.10 logMAR was 94%; the specificity was 71%. The web-based refractive error algorithm measured more myopia progression compared to clinic observations (mean difference SEQ 0.40 ± 0.51 dioptres). Age, sex or use of atropine drops were not significantly associated with test accuracy. CONCLUSIONS: The web-based test for self-assessing vision, performed at home by children with assistance from their parents, yielded VA scores with a precision similar to Snellen chart testing conducted in a clinical setting. However, the web-based refractive error algorithm overestimated myopia progression and requires recalibration for this specific age group.
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BACKGROUND: Digital health interventions (DHIs) have shown promising results in enhancing the management of heart failure (HF). Although health care interventions are increasingly being delivered digitally, with growing evidence on the potential cost-effectiveness of adopting them, there has been little effort to collate and synthesize the findings. OBJECTIVE: This study's objective was to systematically review the economic evaluations that assess the adoption of DHIs in the management and treatment of HF. METHODS: A systematic review was conducted using 3 electronic databases: PubMed, EBSCOhost, and Scopus. Articles reporting full economic evaluations of DHIs for patients with HF published up to July 2023 were eligible for inclusion. Study characteristics, design (both trial based and model based), input parameters, and main results were extracted from full-text articles. Data synthesis was conducted based on the technologies used for delivering DHIs in the management of patients with HF, and the findings were analyzed narratively. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed for this systematic review. The reporting quality of the included studies was evaluated using the CHEERS (Consolidated Health Economic Evaluation Reporting Standards) guidelines. RESULTS: Overall, 27 economic evaluations were included in the review. The economic evaluations were based on models (13/27, 48%), trials (13/27, 48%), or a combination approach (1/27, 4%). The devices evaluated included noninvasive remote monitoring devices (eg, home telemonitoring using digital tablets or specific medical devices that enable transmission of physiological data), telephone support, mobile apps and wearables, remote monitoring follow-up in patients with implantable medical devices, and videoconferencing systems. Most of the studies (24/27, 89%) used cost-utility analysis. The majority of the studies (25/27, 93%) were conducted in high-income countries, particularly European countries (16/27, 59%) such as the United Kingdom and the Netherlands. Mobile apps and wearables, remote monitoring follow-up in patients with implantable medical devices, and videoconferencing systems yielded cost-effective results or even emerged as dominant strategies. However, conflicting results were observed, particularly in noninvasive remote monitoring devices and telephone support. In 15% (4/27) of the studies, these DHIs were found to be less costly and more effective than the comparators (ie, dominant), while 33% (9/27) reported them to be more costly but more effective with incremental cost-effectiveness ratios below the respective willingness-to-pay thresholds (ie, cost-effective). Furthermore, in 11% (3/27) of the studies, noninvasive remote monitoring devices and telephone support were either above the willingness-to-pay thresholds or more costly than, yet as effective as, the comparators (ie, not cost-effective). In terms of reporting quality, the studies were classified as good (20/27, 74%), moderate (6/27, 22%), or excellent (1/27, 4%). CONCLUSIONS: Despite the conflicting results, the main findings indicated that, overall, DHIs were more cost-effective than non-DHI alternatives. TRIAL REGISTRATION: PROSPERO CRD42023388241; https://tinyurl.com/2p9axpmc.
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Salud Digital , Insuficiencia Cardíaca , Telemedicina , Humanos , Análisis Costo-Beneficio , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/economía , Telemedicina/economíaRESUMEN
Remote patient monitoring (RPM) enables clinicians to maintain and adjust their patients' plan of care by using remotely gathered data, such as vital signs, to proactively make medical decisions about a patient's care. RPM interventions have been touted as a means to improve patient care and well-being while reducing costs and resource needs within the health care ecosystem. However, multiple interworking components must be successfully implemented for an RPM intervention to yield the desired outcomes, and the design and key driver of each component can vary depending on the medical context. This viewpoint and perspective paper presents a 4-component RPM infrastructure framework based on a synthesis of existing literature and practice related to RPM. Specifically, these components are identified and considered: (1) data collection, (2) data transmission and storage, (3) data analysis, and (4) information presentation. Interaction points to consider between components include transmission, interoperability, accessibility, workflow integration, and transparency. Within each of the 4 components, questions affecting research and practice emerge that can affect the outcomes of RPM interventions. This framework provides a holistic perspective of the technologies involved in RPM interventions and how these core elements interact to provide an appropriate infrastructure for deploying RPM in health systems. Further, it provides a common vocabulary to compare and contrast RPM solutions across health contexts and may stimulate new research and intervention opportunities.
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Telemedicina , Humanos , Monitoreo Fisiológico/métodosRESUMEN
BACKGROUND: Patient and staff experience is a vital factor to consider in the evaluation of remote patient monitoring (RPM) interventions. However, no comprehensive overview of available RPM patient and staff experience-measuring methods and tools exists. OBJECTIVE: This review aimed at obtaining a comprehensive set of experience constructs and corresponding measuring instruments used in contemporary RPM research and at proposing an initial set of guidelines for improving methodological standardization in this domain. METHODS: Full-text papers reporting on instances of patient or staff experience measuring in RPM interventions, written in English, and published after January 1, 2011, were considered for eligibility. By "RPM interventions," we referred to interventions including sensor-based patient monitoring used for clinical decision-making; papers reporting on other kinds of interventions were therefore excluded. Papers describing primary care interventions, involving participants under 18 years of age, or focusing on attitudes or technologies rather than specific interventions were also excluded. We searched 2 electronic databases, Medline (PubMed) and EMBASE, on February 12, 2021.We explored and structured the obtained corpus of data through correspondence analysis, a multivariate statistical technique. RESULTS: In total, 158 papers were included, covering RPM interventions in a variety of domains. From these studies, we reported 546 experience-measuring instances in RPM, covering the use of 160 unique experience-measuring instruments to measure 120 unique experience constructs. We found that the research landscape has seen a sizeable growth in the past decade, that it is affected by a relative lack of focus on the experience of staff, and that the overall corpus of collected experience measures can be organized in 4 main categories (service system related, care related, usage and adherence related, and health outcome related). In the light of the collected findings, we provided a set of 6 actionable recommendations to RPM patient and staff experience evaluators, in terms of both what to measure and how to measure it. Overall, we suggested that RPM researchers and practitioners include experience measuring as part of integrated, interdisciplinary data strategies for continuous RPM evaluation. CONCLUSIONS: At present, there is a lack of consensus and standardization in the methods used to measure patient and staff experience in RPM, leading to a critical knowledge gap in our understanding of the impact of RPM interventions. This review offers targeted support for RPM experience evaluators by providing a structured, comprehensive overview of contemporary patient and staff experience measures and a set of practical guidelines for improving research quality and standardization in this domain.
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Telemedicina , Humanos , Monitoreo Fisiológico/métodos , Monitoreo Fisiológico/instrumentación , Telemedicina/métodos , Telemedicina/normas , Satisfacción del PacienteRESUMEN
BACKGROUND: The COVID-19 pandemic represented a great stimulus for the adoption of telehealth and many initiatives in this field have emerged worldwide. However, despite this massive growth, data addressing the effectiveness of telehealth with respect to clinical outcomes remain scarce. OBJECTIVE: The aim of this study was to evaluate the impact of the adoption of a structured multilevel telehealth service on hospital admissions during the acute illness course and the mortality of adult patients with flu syndrome in the context of the COVID-19 pandemic. METHODS: A retrospective cohort study was performed in two Brazilian cities where a public COVID-19 telehealth service (TeleCOVID-MG) was deployed. TeleCOVID-MG was a structured multilevel telehealth service, including (1) first response and risk stratification through a chatbot software or phone call center, (2) teleconsultations with nurses and medical doctors, and (3) a telemonitoring system. For this analysis, we included data of adult patients registered in the Flu Syndrome notification databases who were diagnosed with flu syndrome between June 1, 2020, and May 31, 2021. The exposed group comprised patients with flu syndrome who used TeleCOVID-MG at least once during the illness course and the control group comprised patients who did not use this telehealth service during the respiratory illness course. Sociodemographic characteristics, comorbidities, and clinical outcomes data were extracted from the Brazilian official databases for flu syndrome, Severe Acute Respiratory Syndrome (due to any respiratory virus), and mortality. Models for the clinical outcomes were estimated by logistic regression. RESULTS: The final study population comprised 82,182 adult patients with a valid registry in the Flu Syndrome notification system. When compared to patients who did not use the service (n=67,689, 82.4%), patients supported by TeleCOVID-MG (n=14,493, 17.6%) had a lower chance of hospitalization during the acute respiratory illness course, even after adjusting for sociodemographic characteristics and underlying medical conditions (odds ratio [OR] 0.82, 95% CI 0.71-0.94; P=.005). No difference in mortality was observed between groups (OR 0.99, 95% CI 0.86-1.12; P=.83). CONCLUSIONS: A telehealth service applied on a large scale in a limited-resource region to tackle COVID-19 was related to reduced hospitalizations without increasing the mortality rate. Quality health care using inexpensive and readily available telehealth and digital health tools may be delivered in areas with limited resources and should be considered as a potential and valuable health care strategy. The success of a telehealth initiative relies on a partnership between the involved stakeholders to define the roles and responsibilities; set an alignment between the different modalities and levels of health care; and address the usual drawbacks related to the implementation process, such as infrastructure and accessibility issues.
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COVID-19 , Telemedicina , Humanos , COVID-19/mortalidad , Brasil/epidemiología , Estudios Retrospectivos , Telemedicina/estadística & datos numéricos , Femenino , Masculino , Persona de Mediana Edad , Adulto , Anciano , Hospitalización/estadística & datos numéricos , Pandemias , SARS-CoV-2 , Gripe Humana/mortalidad , Gripe Humana/epidemiología , Estudios de CohortesRESUMEN
BACKGROUND: Telemonitoring patients with cardiac implantable electronic devices (CIEDs) can improve their care management. However, the results of cost-effectiveness studies are heterogeneous. Therefore, it is still a matter of debate whether telemonitoring is worth the investment. OBJECTIVE: This systematic review aims to investigate the cost-effectiveness of telemonitoring patients with CIEDs, focusing on its key drivers, and the impact of the varying perspectives. METHODS: A systematic review was performed in PubMed, Web of Science, Embase, and EconLit. The search was completed on July 7, 2022. Studies were included if they fulfilled the following criteria: patients had a CIED, comparison with standard care, and inclusion of health economic evaluations (eg, cost-effectiveness analyses and cost-utility analyses). Only complete and peer-reviewed studies were included, and no year limits were applied. The exclusion criteria included studies with partial economic evaluations, systematic reviews or reports, and studies without standard care as a control group. Besides general study characteristics, the following outcome measures were extracted: impact on total cost or income, cost or income drivers, cost or income drivers per patient, cost or income drivers as a percentage of the total cost impact, incremental cost-effectiveness ratios, or cost-utility ratios. Quality was assessed using the Consensus Health Economic Criteria checklist. RESULTS: Overall, 15 cost-effectiveness analyses were included. All studies were performed in Western countries, mainly Europe, and had primarily a male participant population. Of the 15 studies, 3 (20%) calculated the incremental cost-effectiveness ratio, 1 (7%) the cost-utility ratio, and 11 (73%) the health and cost impact of telemonitoring. In total, 73% (11/15) of the studies indicated that telemonitoring of patients with implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy ICDs was cost-effective and cost-saving, both from a health care and patient perspective. Cost-effectiveness results for telemonitoring of patients with pacemakers were inconclusive. The key drivers for cost reduction from a health care perspective were hospitalizations and scheduled in-office visits. Hospitalization costs were reduced by up to US $912 per patient per year. Scheduled in-office visits included up to 61% of the total cost reduction. Key drivers for cost reduction from a patient perspective were loss of income, cost for scheduled in-office visits and transport. Finally, of the 15 studies, 8 (52%) reported improved quality of life, with statistically significance in only 1 (13%) study (P=.03). CONCLUSIONS: From a health care and patient perspective, telemonitoring of patients with an ICD or a cardiac resynchronization therapy ICD is a cost-effective and cost-saving alternative to standard care. Inconclusive results were found for patients with pacemakers. However, telemonitoring can lead to a decrease in providers' income, mainly due to a lack of reimbursement. Introducing appropriate reimbursement could make telemonitoring sustainable for providers while still being cost-effective from a health care payer perspective. TRIAL REGISTRATION: PROSPERO CRD42022322334; https://tinyurl.com/puunapdr.
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Análisis Costo-Beneficio , Desfibriladores Implantables , Telemedicina , Humanos , Telemedicina/economía , Desfibriladores Implantables/economía , Marcapaso Artificial/economía , Costos de la Atención en Salud/estadística & datos numéricosRESUMEN
BACKGROUND: The current literature inadequately addresses the extent to which remote monitoring should be integrated into care models for chronic respiratory diseases (CRDs). OBJECTIVE: This study examined a remote monitoring program (RMP) in cystic fibrosis (CF) by exploring experiences, future perspectives, and use behavior over 3 years, with the aim of developing future directions for remote monitoring in CRDs. METHODS: This was a mixed methods, multicenter, observational study in 5 Dutch CF centers following a sequential explanatory design. Self-designed questionnaires using the technology acceptance model were sent out to people with CF who had a minimum of 12 months of experience with the RMP and local health care professionals (HCPs). Questionnaire outcomes were used to inform semistructured interviews with HCPs and people with CF. Qualitative findings were reported following the COREQ (Consolidated Criteria for Reporting Qualitative Research) checklist. Anonymous data on use frequency of all people with CF were analyzed. RESULTS: Between the second quarter of 2020 and the end of 2022, a total of 608 people with CF were enrolled in the program, and a total of 9418 lung function tests and 2631 symptom surveys were conducted. In total, 65% (24/37) of HCPs and 89% (72/81) of people with CF responded to the questionnaire, and 7 HCPs and 12 people with CF participated in semistructured interviews. Both people with CF and HCPs were positive about remote monitoring in CF care and found the RMP a good addition to daily care (people with CF: 44/72, 61%; HCPs: 21/24, 88%). Benefits ranged from supporting individual patients to reducing health care consumption. The most valued monitoring tool was home spirometry by both people with CF (66/72, 92%) and HCPs (22/24, 92%). Downsides included the potential to lose sight of patients and negative psychosocial effects, as 17% (12/72) of people with CF experienced some form of stress due to the RMP. A large majority of people with CF (59/72, 82%) and HCPs (22/24, 92%) wanted to keep using the RMP in future, with 79% (19/24) of HCPs and 75% (54/72) of people with CF looking forward to more replacement of in-person care with digital care during periods of well-being. Future perspectives for the RMP were centered on creating hybrid care models, personalizing remote care, and balancing individual benefits with monitoring burden. CONCLUSIONS: Remote monitoring has considerable potential in supporting people with CF and HCPs within the CF care model. We identified 4 practice-based future directions for remote monitoring in CF and CRD care. The strategies, ranging from patient driven to prediction driven, can help clinicians, researchers, and policy makers navigate the rapidly changing digital health field, integrate remote monitoring into local care models, and align remote care with patient and clinician needs.
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Fibrosis Quística , Fibrosis Quística/terapia , Fibrosis Quística/fisiopatología , Humanos , Femenino , Adulto , Masculino , Enfermedad Crónica , Encuestas y Cuestionarios , Telemedicina , Adolescente , Adulto Joven , Países Bajos , Monitoreo Fisiológico/métodos , NiñoRESUMEN
BACKGROUND: The co-design of health technology enables patient-centeredness and can help reduce barriers to technology use. OBJECTIVE: The study objectives were to identify what remote patient monitoring (RPM) technology has been co-designed for inpatients and how effective it is, to identify and describe the co-design approaches used to develop RPM technologies and in which contexts they emerge, and to identify and describe barriers and facilitators of the co-design process. METHODS: We conducted a systematic review of co-designed RPM technologies for inpatients or for the immediate postdischarge period and assessed (1) their effectiveness in improving health outcomes, (2) the co-design approaches used, and (3) barriers and facilitators to the co-design process. Eligible records included those involving stakeholders co-designing RPM technology for use in the inpatient setting or during the immediate postdischarge period. Searches were limited to the English language within the last 10 years. We searched MEDLINE, Embase, CINAHL, PsycInfo, and Science Citation Index (Web of Science) in April 2023. We used the Joanna Briggs Institute critical appraisal checklist for quasi-experimental studies and qualitative research. Findings are presented narratively. RESULTS: We screened 3334 reports, and 17 projects met the eligibility criteria. Interventions were designed for pre- and postsurgical monitoring (n=6), intensive care monitoring (n=2), posttransplant monitoring (n=3), rehabilitation (n=4), acute inpatients (n=1), and postpartum care (n=1). No projects evaluated the efficacy of their co-designed RPM technology. Three pilot studies reported clinical outcomes; their risk of bias was low to moderate. Pilot evaluations (11/17) also focused on nonclinical outcomes such as usability, usefulness, feasibility, and satisfaction. Common co-design approaches included needs assessment or ideation (16/17), prototyping (15/17), and pilot testing (11/17). The most commonly reported challenge to the co-design process was the generalizability of findings, closely followed by time and resource constraints and participant bias. Stakeholders' perceived value was the most frequently reported enabler of co-design. Other enablers included continued stakeholder engagement and methodological factors (ie, the use of flexible mixed method approaches and prototyping). CONCLUSIONS: Co-design methods can help enhance interventions' relevance, usability, and adoption. While included studies measured usability, satisfaction, and acceptability-critical factors for successful implementation and uptake-we could not determine the clinical effectiveness of co-designed RPM technologies. A stronger commitment to clinical evaluation is needed. Studies' use of diverse co-design approaches can foster stakeholder inclusivity, but greater standardization in co-design terminology is needed to improve the quality and consistency of co-design research.