No full-text available
To read the full-text of this research,
you can request a copy directly from the authors.
Metrics for Evaluating Telemedicine in Randomized Controlled Trials: Scoping Review
Abstract
Background
Telemedicine involves medical, diagnostic, and treatment-related services using telecommunication technology. Not only does telemedicine contribute to improved patient quality of life and satisfaction by reducing travel time and allowing patients to be seen in their usual environment, but it also has the potential to improve disease management by making it easier for patients to see a doctor. Recently, owing to IT developments, research on telemedicine has been increasing; however, its usefulness and limitations in randomized controlled trials remain unclear because of the multifaceted effects of telemedicine. Furthermore, the specific metrics that can be used as cross-disciplinary indicators when comparing telemedicine and face-to-face care also remain undefined.
Objective
This review aimed to provide an overview of the general and cross-disciplinarity metrics used to compare telemedicine with in-person care in randomized controlled trials. In addition, we identified previously unevaluated indicators and suggested those that should be prioritized in future clinical trials.
Methods
MEDLINE and Embase databases were searched for publications that met the inclusion criteria according to PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analysis Extension for Scoping Reviews). Original, English-language articles on randomized controlled trials comparing some forms of telemedicine with face-to-face care from January 2019 to March 2024 were included, and the basic information and general metrics used in these studies were summarized.
Results
Of the 2275 articles initially identified, 79 were included in the final analysis. The commonly used metrics that can be used across medical specialties were divided into the following 3 categories: (1) patient-centeredness (67/79, 85%), including patient satisfaction, workload, and quality of life; (2) patient outcomes (57/79, 72%), including general clinical parameters such as death, admission, and adverse events; and (3) cost-effectiveness (40/79, 51%), including cost assessment and quality-adjusted life year. Notably, only 25 (32%) of 79 studies evaluated all the 3 categories. Other metrics, such as staff convenience, system usability, and environmental impact, were extracted as indicators in different directions from the three categories above, although few previous reports have evaluated them (staff convenience: 8/79, 10%; system usability: 3/79, 4%; and environmental impact: 2/79, 3%).
Conclusions
A significant variation was observed in the metrics used across previous studies. Notably, general indicators should be used to enhance the understandability of the results for people in other areas, even if disease-specific indicators are used. In addition, indicators should be established to include all three commonly used categories of measures to ensure a comprehensive evaluation: patient-centeredness, patient outcomes, and cost-effectiveness. Staff convenience, system usability, and environmental impact are important indicators that should be used in future trials. Moreover, standardization of the evaluation metrics is desired for future clinical trials and studies.
Trial Registration
Open Science Forum Registries YH5S7; https://doi.org/10.17605/OSF.IO/YH5S7
ResearchGate has not been able to resolve any citations for this publication.
The effect of self-measurement of blood pressure (BP) at home (home BP measurement, HBPM) has been evaluated over the past decade. This meta-analysis included the latest studies to determine whether HBPM reduced BP (PROSPERO ID: CRD42023442225). PubMed, Cochrane Library Database, and IchuShi-Web were searched for randomized controlled trials after the year 2000 which demonstrated the effect of HBPM on BP change compared with usual care (UC). Overall, 65 articles ( n = 21,053; 63 based on patients with hypertension) were included. The systolic/diastolic BP reduction was significantly greater in the HBPM than in the UC group by 3.27/1.61 mmHg (95% confidence intervals: 2.40–4.15/1.14–2.07) at the end of the intervention, and I ² values ≥ 46.7% suggested moderate-to-high heterogeneity. The funnel plots exhibited no notable publication bias (Egger’s test p ≥ 0.16). HBPM with co-interventions (such as telemonitoring) showed a stronger BP-lowering effect than without co-interventions while the effect of HBPM on BP change remained significant in the absence of co-interventions. HBPM was not associated with systolic BP changes when we combined the four studies that used a wrist cuff device for HBPM. The number of antihypertensive medications increased by 0.17 medications in the HBPM group compared with that in the UC group. There were no significant differences in body mass index changes or risk of severe adverse outcomes between the groups. Our results demonstrated a beneficial effect of HBPM in reducing BP, particularly when used in conjunction with telemonitoring or additional medical support and when employing upper-arm cuff devices.
Health strategies have been used in various health areas, and mobile apps have been used in the context of health self-management. They can be considered an adjuvant intervention in oral health literacy, mainly for people with special health needs. Thus, the aim of this study was to identify the improvement of oral health literacy in patients with special needs when using digital platforms. A systematic literature review, based on the Joanna Briggs Institute (JBI) guidelines, was the main research method employed in this study. A search was undertaken in PubMed/MEDLINE and Cochrane Central Register of Controlled Trials (CENTRAL) databases, according to the relevant Mesh descriptors, their synonyms, and free terms (Entry Terms). Studies published between the years 2012 and 2023 were included. Two researchers independently assessed the quality of the included studies by completing the Newcastle-Ottawa Quality Assessment Scale questionnaire. The analysis corpus comprised 5 articles among the 402 articles selected after applying the inclusion/exclusion criteria (k = 0.97). The evidence from the considered articles is consensual regarding the effectiveness of using new technologies and innovations in promoting oral health literacy in patients with special health needs. The interventions were based on using the Illustration Reinforcement Communication System, inspired by the Picture Exchange Communication System, Nintendo ® Wii™ TV, virtual reality, smartphones, with software applications to read messages sent, Audio Tactile Performance technique, and Art package. One study had a low-quality assessment, and four had a high quality. The evidence from the articles included in this systematic review is consistent regarding the effectiveness of using new technologies and innovations in promoting oral health literacy in patients with special health needs.
Telemedicine has emerged as a transformative force in healthcare delivery, particularly in improving healthcare accessibility. This comprehensive review examines the impact of telemedicine on healthcare accessibility, exploring its ability to overcome geographical, financial, sociocultural, and infrastructural barriers to healthcare access. Through remote consultations, monitoring, and diagnosis facilitated by technology, telemedicine extends healthcare reach to remote and underserved areas while enhancing temporal accessibility with round-the-clock availability. By streamlining healthcare delivery systems, telemedicine reduces costs and promotes efficiency, ultimately fostering health equity and improving health outcomes. However, technological barriers, regulatory hurdles, and patient acceptance remain. To realize telemedicine's full potential, collaboration among stakeholders in the healthcare and technology sectors is imperative. Policymakers must enact supportive regulations, healthcare providers must integrate telemedicine into their practices, and technology companies must innovate to develop user-friendly platforms. Through concerted efforts, telemedicine can catalyze advancing healthcare accessibility and enhance the health and well-being of individuals worldwide.
Purpose
In response to the growing challenges posed by an aging society, a telemedicine system was developed specifically for older adults postoperative patients, and its effectiveness was thoroughly investigated.
Methods
Between May 2020 and May 2022, a total of 88 older adults postoperative patients were enrolled and randomly allocated into an experimental group and a control group. The experimental group received telemedicine services after discharge, while the control group received conventional medical services following the traditional protocol. One month after discharge, various indicators were evaluated for both groups, including number of visits, medical expenditures, postoperative recovery, anxiety, depression and satisfaction.
Results
The number of visits and medical expenditures of the experimental group were less than those of the control group [1 (0, 1) vs. 1 (1, 2), Z = −3.977, p < 0.001; 25.25 (0.00, 277.40) yuan vs. 174.65 (49.63, 446.10) yuan, Z = −2.150, p = 0.032]. In both groups, there were 2 cases of incision infection, respectively. No significant difference was observed between the two groups (Fisher χ², p = 0.259). In both groups, there was no instance of incision bleeding, incision dehiscence, readmission, or reoperation. Additionally, there was no significant difference in physical status between the two groups at discharge and after discharge (66.06 ± 8.92 vs. 65.45 ± 7.39 t = 0.287, p = 0.775; 73.33 ± 9.97 vs. 70.91 ± 7.50, t = 1.202, p = 0.235). And there was no significant difference in the change of physical status between the two groups after discharge [10.00 (0.00, 10.00) vs. 5.00 (0.00, 10.00), Z = −1.077, p = 0.281]. There was no significant difference in body weight change between the two groups after discharge [1.05 (0.38, 1.60) Kg vs. 0.80 (0.50, 1.43) Kg, Z = −0.265, p = 0.791]. There was no significant difference in the levels of anxiety and depression between the two groups at discharge (45.64 ± 8.10 vs. 44.60 ± 8.24, t = 0.520, p = 0.604, 48.33 ± 8.46 vs. 47.50 ± 6.85, t = 0.418, p = 0.677). But the levels of anxiety and depression in the experimental group were lower than those in the control group after discharge (34.92 ± 7.38 vs. 39.03 ± 8.42, t = −2.183, p = 0.032, 37.86 ± 7.29 vs. 41.93 ± 7.13, t = −2.281, p = 0.025); The change of anxiety level and depression level of the experimental group were more than those of the control group [−10.00 (−11.25, −8.75) vs. −5.00 (−7.81, −3.75), Z = −5.277, p < 0.001; −10.00 (−12.50, −7.50) vs. −5.00 (−7.75, −3.44), Z = −4.596, p < 0.001]. The level of satisfaction regarding medical services, daily care, and psychological comfort was higher in the experimental group compared to the control group [3 (3, 3.25) vs. 2 (1, 2), Z = −5.931, p < 0.001; 3 (3, 4) vs. 3 (2, 3), Z = −2.286, p = 0.022; 2 (1, 3) vs. 1 (0.75, 2), Z = −2.081, p = 0.037].
Conclusion
In the context of an aging society, telemedicine system can offer improved healthcare to older adults postoperative patients. This includes benefits such as reducing number of visits, saving medical expenditures, enhancing psychological comfort and daily care.
This study aim to investigate if remote intensive coaching for the first 6 months post-AMI will improve adherence to the twice-a-day antiplatelet medication, ticagrelor. Between July 8, 2015, to March 29, 2019, AMI patients were randomly assigned to remote intensive management (RIM) or standard care (SC). RIM participants underwent 6 months of weekly then two-weekly consultations to review medication side effects and medication adherence coaching by a centralized nurse practitioner team, whereas SC participants received usual cardiologist face-to-face consultations. Adherence to ticagrelor were determined using pill counting and serial platelet reactivity measurements for 12 months. A total of 149 (49.5%) of participants were randomized to RIM and 152 (50.5%) to SC. Adherence to ticagrelor was similar between RIM and SC group at 1 month (94.4 ± 0.7% vs. 93.6±14.7%, p = 0.537), 6 months (91.0±14.6% vs. 90.6±14.8%, p = 0.832) and 12 months (87.4±17.0% vs. 89.8±12.5%, p = 0.688). There was also no significant difference in platelet reactivity between the RIM and SC groups at 1 month (251AU*min [212–328] vs. 267AU*min [208–351], p = 0.399), 6 months (239AU*min [165–308] vs. 235AU*min [171–346], p = 0.610) and 12 months (249AU*min [177–432] vs. 259AU*min [182–360], p = 0.678). Sensitivity analysis did not demonstrate any association of ticagrelor adherence with bleeding events and major adverse cardiovascular events. RIM, comprising 6 months of intensive coaching by nurse practitioners, did not improve adherence to the twice-a-day medication ticagrelor compared with SC among patients with AMI. A gradual decline in ticagrelor adherence over 12 months was observed despite 6 months of intensive coaching.
This study evaluates a complex telemedicine-based intervention targeting patients with chronic health problems. Computer tablets and home telemonitoring devices are used by patients to report point-of-care measurements, e.g., blood pressure, blood glucose or oxygen saturation, and to answer health-related questions at a follow-up center. We designed a pragmatic randomized controlled trial to compare the telemedicine-based intervention with usual care in six local centers in Norway. The study outcomes included health-related quality of life (HRQoL) based on the EuroQol questionnaire (EQ-5D-5L), patient experiences, and utilization of healthcare. We also conducted a cost–benefit analysis to inform policy implementation, as well as a process evaluation (reported elsewhere). We used mixed methods to analyze data collected during the trial (health data, survey data and interviews with patients and health personnel) as well as data from national health registers. 735 patients were included during the period from February 2019 to June 2020. One year after inclusion, the effects on the use of healthcare services were mixed. The proportion of patients receiving home-based care services declined, but the number of GP contacts increased in the intervention group compared to the control group. Participants in the intervention group experienced improved HRQoL compared to the control group and were more satisfied with the follow-up of their health. The cost–benefit of the intervention depends largely on the design of the service and the value society places on improved safety and self-efficacy.
Purpose
Previous studies assessed different components of telemedicine management pathway for OSA instead of the whole pathway. This randomized, controlled, and non-inferiority trial aimed to assess whether telemedicine management is clinically inferior to in-person care in China.
Methods
Adults suspected of OSA were randomized to telemedicine (web-based questionnaires, self-administered home sleep apnea test [HSAT], automatically adjusting positive airway pressure [APAP], and video-conference visits) or in-person management (paper questionnaires, in-person HSAT set-up, APAP, and face-to-face visits). Participants with an apnea–hypopnea index (AHI) ≥ 15 events/hour received APAP for 3 months. The non-inferiority analysis was based on the change in Functional Outcomes of Sleep Questionnaire (FOSQ) score and APAP adherence. Cost-effectiveness analysis was performed.
Results
In the modified intent-to-treat analysis set (n = 111 telemedicine, 111 in-person), FOSQ scores improved 1.73 (95% confidence interval [CI], 1.31–2.14) points with telemedicine and 2.05 (1.64–2.46) points with in-person care. The lower bound of the one-sided 95% non-inferiority CI for the difference in change between groups of − 0.812 was larger than the non-inferiority threshold of − 1. APAP adherence at 3 months was 243.3 (223.1–263.5) minutes/night for telemedicine and 241.6 (221.3–261.8) minutes/night for in-person care. The lower bound of the one-sided 95% non-inferiority CI of − 22.2 min/night was higher than the non-inferiority delta of − 45 min/night. Telemedicine had lower total costs than in-person management (CNY 1482.7 ± 377.2 vs. 1912.6 ± 681.3; p < 0.0001), driven by patient costs, but no significant difference in QALYs.
Conclusions
Functional outcomes and adherence were not clinically inferior in patients managed by a comprehensive telemedicine approach compared to those receiving in-person care in China.
Clinical trial registration
https://www.chictr.org.cn, Registration number ChiCTR2000030546. Retrospectively registered on March 06, 2020.
Purpose
This study evaluated the treatment acceptance rate and cost-effectiveness of the telemedicine model in clinical practice for adult patients with obstructive sleep apnea (OSA).
Patients and Methods
Patients admitted to the sleep center for snoring were randomly divided into telemedicine and control groups. Patients diagnosed with moderate-to-severe OSA using the Home Sleep Apnea Test (HSAT) were voluntarily treated with auto-adjusted positive airway pressure (APAP) therapy. The acceptance rate of the APAP treatment, cost of patient visits, time cost, and labor cost of doctors in the two groups were observed.
Results
A total of 57 subjects were included, with an average age of 40.12±11.73 years, including 47 males (82.5%); 26 patients were in the telemedicine group, and 31 were in the control group. Follow-up results showed that the acceptance rate of APAP treatment was 57.7% and 54.8% in the telemedicine and control groups, respectively, with no significant difference between the two groups (p=0.829). The cost-benefit analysis showed that the telemedicine group reduced the cost of patients’ medical treatment [−457.84(−551.19,1466.87)] but increased the extra intervention frequency and time outside the doctor’s office. Further analysis showed that male subjects of older age, higher education level, distant residence, no fatty liver, poor sleep quality, severe insomnia, and higher OSA severity were more likely to receive telemedicine diagnosis and treatment.
Conclusion
The APAP treatment acceptance rate and compliance of OSA patients in the telemedicine group were similar to those in the control group, and the cost of patients’ medical treatment was reduced. However, telemedicine increases the frequency and duration of additional out-of-hospital interventions.
Background
Multiple sclerosis (MS) is a chronic autoimmune disease, affecting about 2.5 million people worldwide. Telemedicine is a relatively recent telecommunication tool that has multiple formats such as store-and-forward, interactive video conferencing, remote medical record access, and remote patient monitoring. Telemedicine can be used to assess individuals with MS regarding their disease process, the development and impact of new symptoms as well as inquire about health behaviors that promote effective self-management. In this study, we aimed to evaluate the effect of telemedicine on patient satisfaction, clinical outcome and financial feasibility for MS patients.
Results
Sixty MS patients from the MS unit, at Kafr Elshikh General Hospital, were recruited and divided into 2 groups; 30 in the telemedicine group and 30 in the control group. Both groups were followed up for 12 months. We found a significant difference between the telemedicine group compared to controls as it showed less severe visual symptoms ( p 0.006), a smaller number of dropouts ( p 0.034) and higher patient satisfaction, with no significant difference between the two groups in the number of relapses, gait, bowel and bladder, lower limb weakness.
Conclusion
Telemedicine was found to be a promising practice that can be used to promote, coordinate and adjust ongoing clinical services of MS patients.
Objective:
This pragmatic randomized control trial aimed to evaluate clinical efficacy of the Making Sense of Brain Tumour program delivered via videoconferencing (Tele-MAST) for improving mental health and quality of life (QoL) relative to standard care in individuals with primary brain tumor (PBT).
Method:
Adults with PBT experiencing at least mild distress (Distress Thermometer ≥4) and caregivers were randomly allocated to the 10-session Tele-MAST program or standard care. Mental health and QoL were assessed pre-intervention, post-intervention (primary endpoint), and 6-weeks and 6-months follow-up. The primary outcome was clinician-rated depressive symptoms on the Montgomery-Asberg Depression Rating Scale.
Results:
82 participants with PBT (34% benign, 20% lower-grade glioma, 46% high-grade glioma) and 36 caregivers were recruited (2018-2021). Controlling for baseline functioning, Tele-MAST participants with PBT had lower depressive symptoms at post-intervention (95% CI: 10.2-14.6, vs. 15.2-19.6, p = 0.002) and 6-weeks post-intervention (95% CI: 11.5-15.8 vs. 15.6-19.9, p = 0.010) than standard care, and were almost 4 times more likely to experience clinically reduced depression (OR, 3.89; 95% CI: 1.5-9.9). Tele-MAST participants with PBT also reported significantly better global QoL, emotional QoL and lower anxiety at post-intervention and 6-weeks post-intervention than standard care. There were no significant intervention effects for caregivers. At 6-months follow-up participants with PBT who received Tele-MAST reported significantly better mental health and QoL relative to pre-intervention.
Conclusions:
Tele-MAST was found to be more effective for reducing depressive symptoms at post-intervention than standard care for people with PBT but not caregivers. Tailored and extended psychological support may be beneficial for people with PBT.
Objective
Increasing evidence indicates that the telehealth (TH) model is noninferior to the in-person approach regarding metabolic control in type 1 diabetes (T1D) and offers advantages such as a decrease in travel time and increased accessibility for shorter/frequent visits. The primary aim of this study was to compare the change in glycated hemoglobin (HbA1c) at 6 months in T1D care in a rural area between TH and in-person visits.
Research design and methods
Randomized controlled, open-label, parallel-arm study among adults with T1D. Participants were submitted to in-person visits at baseline and at months 3 and 6 (conventional group) or teleconsultation in months 1 to 4 plus 2 in-person visits (baseline and 6 months) (TH group). Mixed effects models estimated differences in HbA1c changes.
Results
Fifty-five participants were included (29 conventional/26 TH). No significant differences in HbA1c between groups were found. Significant improvement in time in range (5.40, 95% confidence interval (CI): 0.43-10.38; p < 0.05) and in time above range (-6.34, 95% CI: -12.13- -0.55;p < 0.05) in the TH group and an improvement in the Diabetes Quality of Life questionnaire (EsDQoL) score (-7.65, 95% CI: -14.67 - -0.63; p < 0.05) were observed. In TH, the costs for the participants were lower.
Conclusions
The TH model is comparable to in-person visits regarding HbA1c levels at the 6-month follow-up, with significant improvement in some glucose metrics and health-related quality of life. Further studies are necessary to evaluate a more efficient timing of the TH visits.
Aims:
Despite strong recommendations, outpatient cardiac rehabilitation is underused in chronic heart failure (CHF) patients. Possible barriers are frailty, accessibility, and rural living, which may be overcome by telerehabilitation. We designed a randomized, controlled trial to evaluate the feasibility of a 3-month real-time, home-based telerehabilitation, high-intensity exercise programme for CHF patients who are either unable or unwilling to participate in standard outpatient cardiac rehabilitation and to explore outcomes of self-efficacy and physical fitness at 3 months post-intervention.
Methods and results:
CHF patients with reduced (≤40%), mildly reduced (41-49%), or preserved ejection fraction (≥50%) (n = 61) were randomized 1:1 to telerehabilitation or control in a prospective controlled trial. The telerehabilitation group (n = 31) received real-time, home-based, high-intensity exercise for 3 months. Inclusion criteria were (i) ≥18 years, (ii) New York Heart Association class II-III, stable on optimized medical therapy for >4 weeks, and (iii) N-terminal pro-brain natriuretic peptide >300 ng/L. All participants participated in a 2-day 'Living with heart failure' course. No other intervention beyond standard care was provided for controls. Outcome measures were adherence, adverse events, self-reported outcome measures, the general perceived self-efficacy scale, peak oxygen uptake (VO2peak ) and a 6-min walk test (6MWT). The mean age was 67.6 (11.3) years, and 18% were women. Most of the telerehabilitation group (80%) was adherent or partly adherent. No adverse events were reported during supervised exercise. Ninety-six per cent (26/27) reported that they felt safe during real-time, home-based telerehabilitation, high-intensity exercise, and 96% (24/25) reported that, after the home-based supervised telerehabilitation, they were motivated to participate in further exercise training. More than half the population (15/26) reported minor technical issues with the videoconferencing software. 6MWT distance increased significantly in the telerehabilitation group (19 m, P = 0.02), whereas a significant decrease in VO2peak (-0.72 mL/kg/min, P = 0.03) was observed in the control group. There were no significant differences between the groups in general perceived self-efficacy scale, VO2peak , and 6MWT distance after intervention or at 3 months post-intervention.
Conclusions:
Home-based telerehabilitation was feasible in chronic heart failure patients inaccessible for outpatient cardiac rehabilitation. Most participants were adherent when given more time and felt safe exercising at home under supervision, and no adverse events occurred. The trial suggests that telerehabilitation can increase the use of cardiac rehabilitation, but the clinical benefit of telerehabilitation must be evaluated in larger trials.
Healthcare systems are responsible for 4%–5% of the emissions of greenhouse gases worldwide. The Greenhouse Gas Protocol divides carbon emissions into three scopes: scope 1 or direct emissions secondary to energy use; scope 2 or indirect emissions secondary to purchased electricity; and scope 3 for the rest of indirect emissions.
Aim
To describe the environmental impact of health services.
Design
A systematic review was conducted in the Medline, Web of Science, CINAHL, and Cochrane databases. Studies that focused their analysis on a functional healthcare unit and which included. This review was conducted from August to October 2022.
Results
The initial electronic search yielded a total of 4368 records. After the screening process according to the inclusion criteria, 13 studies were included in this review. The reviewed studies found that between 15% and 50% of the total emissions corresponded to scopes 1 and 2 emissions, whereas scope 3 emissions ranged between 50% and 75% of the total emissions. Disposables, equipment (medical and non‐medical) and pharmaceuticals represented the higher percentage of emissions in scope 3.
Conclusion
Most of the emissions corresponded to scope 3, which includes the indirect emission occurring as a consequence of the healthcare activity, as this scope includes a wider range of emission sources than the other scopes.
Implications for the profession and/or patient care
Interventions should be carried out by the healthcare organizations responsible of Greenhouse Gas emissions, and also every single individual that integrates them should make changes. The use of evidence‐based approaches to identify carbon hotspots and implement the most effective interventions in the healthcare setting could lead to a significant reduction of carbon emissions.
Impact
This literature review highlights the impact that healthcare systems have on climate change and the importance of adopting and carrying out interventions to prevent its fast development.
Reporting Method
This review adhered to PRISMA guideline. PRISMA 2020 is a guideline designed for systematic reviews of studies that analyse the effects of heath interventions, and aim is to help authors improve the reporting of systematic review and meta‐analyses.
Patient or Public Contribution
No Patient or Public Contribution.
(1) Background: Patients’ experiences and satisfaction with their treatment are becoming increasingly important in the context of quality assurance, but the measurement of these parameters is accompanied by several disadvantages such as poor cross-country comparability and methodological problems. The aim of this review is to describe and summarize the process of measuring, publishing, and utilizing patient experience and satisfaction data in countries with highly developed healthcare systems in Europe (Germany, Sweden, Finland, Norway, the United Kingdom) and the USA to identify possible approaches for improvement. (2) Methods: Articles published between 2000 and 2021 that address the topics described were identified. Furthermore, patient feedback in social media and the influence of sociodemographic and hospital characteristics on patient satisfaction and experience were evaluated. (3) Results: The literature reveals that all countries perform well in collecting patient satisfaction and experience data and making them publicly available. However, due to the use of various different questionnaires, comparability of the results is difficult, and consequences drawn from these data remain largely unclear. (4) Conclusions: Surveying patient experience and satisfaction with more unified as well as regularly updated questionnaires would be helpful to eliminate some of the described problems. Additionally, social media platforms must be considered as an increasingly important source to expand the range of patient feedback.
Rationale:
Despite the benefits of pulmonary rehabilitation in chronic obstructive pulmonary disease (COPD), many patients do not access or complete pulmonary rehabilitation, and long-term maintenance of exercise is difficult.
Objectives:
To compare long-term telerehabilitation or unsupervised treadmill training at home with standard care.
Methods:
In an international randomized controlled trial, patients with COPD were assigned to three groups (telerehabilitation, unsupervised training, control) and followed up for 2 years. Telerehabilitation consisted of individualized treadmill training at home supervised by a physiotherapist and self-management. The unsupervised training group performed unsupervised treadmill exercise at home. The control group received standard care. The primary outcome was the combined number of hospitalizations and emergency department presentations. Secondary outcomes included time free from first event; exercise capacity; dyspnea; health status; quality of life; anxiety; depression; self-efficacy; subjective impression of change.
Measurements and main results:
120 participants were randomized. The incidence rate of hospitalizations and emergency department presentations was lower in telerehabilitation (1.18 events per person-year, 95% CI: 0.94, 1.46) and unsupervised training group (1.14, 95% CI: 0.92, 1.41) than in the control group (1.88, 95% CI: 1.58, 2.21; P < 0.001 compared to intervention groups). Telerehabilitation and unsupervised training groups experienced better health status for 1 year. Intervention participants reached and maintained clinically significant improvements in exercise capacity.
Conclusions:
Long-term telerehabilitation and unsupervised training at home in COPD are both successful in reducing hospital readmissions and can broaden the availability of pulmonary rehabilitation and maintenance strategies. Clinical trial registration available at www.
Clinicaltrials:
gov, ID: NCT02258646.
Background:
Following the Riyadh Declaration, digital health technologies were prioritized in many countries to address the challenges of the COVID-19 pandemic. Digital health apps for telemedicine and video consultations help reduce potential disease spread in routine healthcare, including follow-up care in orthopedic and trauma surgery. In addition to the satisfaction, efficiency, and safety of telemedicine, its economic and environmental effects are highly relevant to decision makers, particularly for the goal of reaching carbon neutrality of healthcare systems.
Objective:
This study aims to provide the first comprehensive health economic and environmental analysis of video consultations in follow-up care after knee and shoulder interventions in an orthopedic and trauma surgery department of a German university hospital. The analysis is conducted from a societal perspective. We analyze both the economic and the environmental impact of video consultations, taking into account the goal of carbon neutrality for the German healthcare system by 2030.
Methods:
We conducted a prospective randomized controlled trial in a German university hospital comparing follow-up care with digital health app video consultations (intervention group) to conventional face-to-face consultations in the clinic (control group). Economic impact included the analysis of travel costs, time costs, and production losses. Examination of the environmental impact comprised the emissions of greenhouse gases, carbon monoxides, volatile hydrocarbons, nitrogen oxides, particulates, and the calculation of environmental costs. Sensitivity analysis included calculations with a higher cost per ton of carbon dioxide equivalent which gives equal weight to the welfare of present and future generations.
Results:
Data from 52 patients indicated that, from the patients' point of view, telemedicine helped to reduce travel costs, time costs, and production losses, resulting in mean cost savings of €76.52 per video consultation when compared with a face-to-face consultation. In addition, emissions of 11.248 kg of greenhouse gases, 0.070 kg of carbon monoxides, 0.011 kg of volatile hydrocarbons, 0.028 kg of nitrogen oxides, and 0.00004 kg of particulates could be saved per patient through avoided travel. This resulted in savings of environmental costs between €3.73 and €9.53 per patient.
Conclusions:
We presented the first comprehensive analysis of economic and environmental effects of telemedicine in the follow-up care of orthopedic and trauma surgery patients in Germany. Video consultations were found to reduce the environmental footprint of follow-up care, saved travel costs, travel time, and time costs for patients and helped to lower production losses. Our findings can support the decision-making on the utilization of digital health during and beyond the COVID-19 pandemic, providing decision-makers with data for both the economic and the environmental effects. Thanks to the pragmatic design of our study, our findings can be applied to a wide range of clinical contexts and potential digital health applications that substitute outpatient hospital visits with video consultations.
Clinicaltrial:
German Clinical Trials Register DRKS00023445; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023445.
Background:
Telemedicine provides healthcare to patients at a distance from their treating clinician. There is a lack of high-quality evidence to support the safety and acceptability of telemedicine for postoperative outpatient follow-up. This randomized controlled trial-conducted before the COVID-19 pandemic-aimed to assess patient satisfaction and safety (as determined by readmission, reoperation and complication rates) by telephone compared to face-to-face follow-up after uncomplicated general surgical procedures.
Methods:
Patients following laparoscopic appendicectomy or cholecystectomy and laparoscopic or open umbilical or inguinal hernia repairs were randomized to a telephone or face-to-face outpatient clinic. Patient demographics, perioperative details and postoperative outcomes were compared. Patient satisfaction was assessed via a standardized Likert-style scale.
Results:
One hundred and twenty-three patients were randomized over 12 months. Mean consultation times were significantly shorter for telemedicine than face-to-face clinics (telemedicine 10.52 ± 7.2 min, face-to-face 15.95 ± 9.96 min, P = 0.0021). There was no difference between groups in the attendance rates, nor the incidence or detection of postoperative complications. Of the 58 patients randomized to the telemedicine arm, 40% reported high, and 60% reported very high satisfaction with the method of clinic follow-up.
Conclusion:
Telemedicine postoperative follow-up is safe and acceptable to patients and could be considered in patients undergoing uncomplicated benign general surgery.
Objective
The GERONTACCESS trial evaluated the utility and cost-effectiveness of a gerontological telemedicine (TLM) programme for preventing unplanned hospitalisation of residents living in nursing homes (NHs) in regions lacking medical facilities and/or qualified medical providers (“medical deserts”).
Design
GERONTACCESS was a 12-month, multicentre, prospective cluster-randomised trial conducted in NHs. The intervention group underwent TLM assessments every 3 months. The control group received the usual care. In both groups, comprehensive on-site assessments were conducted at baseline and the final visit. Care requirements were documented throughout the study.
Setting and participants
NH residents aged ≥ 60 years with multiple chronic diseases.
Methods
The study outcomes were the proportion of patients who experienced avoidable and unplanned hospitalisation, and the incremental cost savings per quality-adjusted life years from baseline to the 12-month follow-up.
Results
Of the 426 randomised participants (mean ± standard deviation age, 87.2 ± 7.6 years; 311 [73.0%] women), 23.4% in the intervention group and 32.5% in the control group experienced unplanned hospitalisation (odds ratio [OR] = 0.73, 95% confidence interval [CI] 0.43 to 0.97; p = 0.034). Each avoided hospitalisation in the intervention group saved $US 3,846.
Conclusions and implications
The results of GERONTACCESS revealed that our gerontological, preventative TLM program significantly reduced unplanned hospitalisations. This innovative intervention limited disease progression and promoted a healthy lifestyle among NH residents.
Trial registration
Clinicaltrials.gov, NCT02816177, registered June 28, 2016.
Background:
The benefits of cardiac rehabilitation (CR) are already well established; however, such intervention has been underused, mainly in low- and middle-income countries.
Aim:
To compare adherence, effectiveness, and cost of a home CR with the traditional CR (TCR) in a middle-income country (MIC).
Design:
Single-blind randomized control trial.
Setting:
A university hospital.
Population:
Individuals with coronary disease that were eligible were invited to participate. A randomized sample of 51 individuals was selected, where two participants were not included by not meeting inclusion criteria.
Methods:
The home-CR group participated in health education activities, carried out two supervised exercise sessions, and was instructed to carry out 58 sessions at home. Weekly telephone calls were made. The TCR group held 24 supervised exercise sessions and were instructed to carry out 36 sessions at home.
Results:
49 individuals (42 male, 56.37±10.35years) participated in the study, 23 in the home-CR group and 26 in the TCR group. After the intervention, adherence in the home-CR and TCR groups was 94.18% and 79.08%, respectively, with no significant difference (p = 0.191). Both protocols were effective for the other variables, with no differences. The cost per patient for the service was lower in the home-CR (US 135.05).
Conclusions:
CR performed at home in an MIC demonstrated similar adherence and effectiveness compared to the TCR program, but with a lower cost for the service. The results corroborate the possibility of using home CR programs, even in MICs, after exercise risk stratification and under remote supervision.
Clinical rehabilitation impact:
Home-CR can contribute to overcome participants' barriers with compatible cost. Home-CR is effective in improving functional capacity and risk factors control. Perform risk stratification and remote supervision are essential to offer Home-CR.
Background:
Smartphone compatible wearables have been released on the consumers market, enabling remote monitoring. Remote monitoring is often named as a tool to reduce the cost of care.
Objective:
The primary purpose of this paper is to describe a cost-utility analysis of an eHealth intervention compared to regular follow-up in patients with acute myocardial infarction (AMI).
Methods:
In this trial, of which clinical results have been published previously, patients with an AMI were randomized in a 1:1 fashion between an eHealth intervention and regular follow-up. The remote monitoring intervention consisted of a blood pressure monitor, weight scale, electrocardiogram device, and step counter. Furthermore, two in-office outpatient clinic visits were replaced by e-visits. The control group received regular care. The differences in mean costs and quality of life per patient between both groups during one-year follow-up were calculated.
Results:
Mean costs per patient were €2417±2043 (US 3175±3255) for the control group. This yielded a cost reduction of €471 (US -302 to $1338). The average quality-adjusted life years in the first year of follow-up was 0.74 for the intervention group and 0.69 for the control (difference -0.05, 95% CI -0.09 to -0.01; P=.01).
Conclusions:
eHealth in the outpatient clinic setting for patients who suffered from AMI is likely to be cost-effective compared to regular follow-up. Further research should be done to corroborate these findings in other patient populations and different care settings.
Trial registration:
ClinicalTrials.gov NCT02976376; https://clinicaltrials.gov/ct2/show/NCT02976376.
International registered report identifier (irrid):
RR2-10.2196/resprot.8038.
Aim
The objective of this study was to assess the impact of health care-initiated visits versus patient-controlled flexible visits on clinical and patient-reported outcomes in people with type 1 diabetes.
Methods
The DiabetesFlex trial was a randomized controlled, pragmatic non-inferiority 15-month follow-up study comparing standard care (face-to-face visits every four months) with DiabetesFlex (patient-controlled flexible visits using patient-reported outcomes-based telehealth follow-up). Of 343 enrolled participants, 160 in each group completed the study. The primary outcome was mean change in HbA1c from baseline to 15-month follow-up. Secondary outcomes were blood pressure, lipid levels, frequency of visits, the World Health Organization score - five well-being-index (WHO-5), the Problem Areas In Diabetes (PAID) scale and experience of participation in own care (participation score).
Results
The adjusted mean difference in HbA1c between standard care and DiabetesFlex was similar and below the predefined non-inferiority margin of 0.4%(-0.03%[95%CI:0.15,0.11]/-0.27 mmol/mol[-1.71,1.16]). No intergroup mean changes in lipid or blood pressure were observed. Conversely, DiabetesFlex participants presented an increased mean WHO-5 index of 4.5 (1.3,7.3), participation score of 1.1 (0.5,2.0), and decreased PAID score of -4.8 (-7.1,-2.6) when compared with standard care. During follow-up, DiabetesFlex participants actively changed 23% of face-to-face visits to telephone consultations, cancelled more visits (17% vs. 9%), and stayed away without cancellation less often (2% vs. 8%).
Conclusion
Compared with standard care, flexible patient-controlled visits combined with patient-reported outcomes in participants with metabolic controlled type 1 diabetes and good psychological well-being further improved diabetes-related well-being and decreased face-to-face visits while maintaining safe diabetes management.
Background:
Geographical, financial and travel-related barriers may impact access to necessary health care for people in need of long-term follow-up.
Objective:
The goal of the research was to perform a nonblinded, randomized, controlled trial on health-related quality of life (HRQoL), healing, interaction, and satisfaction of patients with spinal cord injury (SCI) and PI receiving multidisciplinary videoconference consultations from a wound clinic to the participant's home versus regular outpatient care. The multidisciplinary team consisted of a medical doctor, a wound nurse, and an occupational therapist. In both groups, district nurses attended the consultations at the participant's home.
Methods:
A total of 56 participants, 28 in each group, were randomized to a videoconference group (VCG) or a regular care group (RCG). Validated questionnaires were used to measure and compare the follow-up effect on HRQoL. Percentage reduction of wound volume was measured at end of the follow-up. A Likert scale was used to measure the satisfaction of the patients and district nurses regarding the interaction between different modalities of care in the 2 groups.
Results:
The HRQoL did not show significant differences between the 2 groups (P values ranging from .09 to .88) or the rate of PI healing, experienced interaction, and satisfaction in the groups. A total of 67% (37/55) of all PIs healed, 64% (18/28) in the VCG and 70% (19/27) in the RCG. Mean reduction in ulcer volume was 79% in the VCG and 85% in the RCG (P=.32). A Kaplan-Meier plot with a logrank test regarding time to healing did not show any significant difference between the 2 groups.
Conclusions:
Videoconference-based care seems to be a safe and efficient way to manage PIs in terms of HRQoL, healing, interaction, and satisfaction compared to conventional care for people with SCI. This should be considered when planning for future care. SCI has a huge impact on the individual, the family, and the health care system. There is an urgent need to improve systems of care so that individuals who live far from specialists and require long-term follow-up for conditions such as PI can get optimal treatment.
Trial registration:
ClinicalTrials.gov NCT02800915; https://clinicaltrials.gov/ct2/show/NCT02800915 and Current Research Information System in Norway (CRISTIN) 545284; https://app.cristin.no/projects/show.jsf?id=545284.
Objective
To evaluate the effectiveness of remote proactive management of toxicities during chemotherapy for early stage breast cancer.
Design
Pragmatic, cluster randomised trial.
Setting
20 cancer centres in Ontario, Canada, allocated by covariate constrained randomisation to remote management of toxicities or routine care.
Participants
All patients starting adjuvant or neoadjuvant chemotherapy for early stage breast cancer at each centre. 25 patients from each centre completed patient reported outcome questionnaires.
Interventions
Proactive, standardised, nurse led telephone management of common toxicities at two time points after each chemotherapy cycle.
Main outcome measures
The primary outcome, cluster level mean number of visits to the emergency department or admissions to hospital per patient during the whole course of chemotherapy treatment, was evaluated with routinely available administrative healthcare data. Secondary patient reported outcomes included toxicity, self-efficacy, and quality of life.
Results
Baseline characteristics of participants were similar in the intervention (n=944) and control arms (n=1214); 22% were older than 65 years. Penetration (that is, the percentage of patients who received the intervention at each centre) was 50-86%. Mean number of visits to the emergency department or admissions to hospital per patient was 0.91 (standard deviation 0.28) in the intervention arm and 0.94 (0.40) in the control arm (P=0.94); 47% (1014 of 2158 patients) had at least one visit to the emergency department or a hospital admission during chemotherapy. Among 580 participants who completed the patient reported outcome questionnaires, at least one grade 3 toxicity was reported by 48% (134 of 278 patients) in the intervention arm and by 58% (163 of 283) in the control arm. No differences in self-efficacy, anxiety, or depression were found. Compared with baseline, the functional assessment of cancer therapy trial outcome index decreased by 6.1 and 9.0 points in the intervention and control participants, respectively.
Conclusions
Proactive, telephone based management of toxicities during chemotherapy did not result in fewer visits to the emergency department or hospital admissions. With the rapid rise in remote care because of the covid-19 pandemic, identifying scalable strategies for remote management of patients during cancer treatment is particularly relevant.
Trial registration
ClinicalTrials.gov NCT02485678 .
Importance
Cardiac telerehabilitation (CTR) has been found to be a safe and beneficial alternative to traditional center-based cardiac rehabilitation (CR) and might be associated with higher participation rates by reducing barriers to CR use. However, implementation of CTR interventions remains low, which may be owing to a lack of cost-effectiveness analyses of data from large-scale randomized clinical trials.
Objective
To assess the cost-effectiveness of CTR with relapse prevention compared with center-based CR among patients with coronary artery disease.
Design, Setting, and Participants
This economic evaluation performed a cost-utility analysis of data from the SmartCare-CAD (Effects of Cardiac Telerehabilitation in Patients With Coronary Artery Disease Using a Personalized Patient-Centred ICT Platform) randomized clinical trial. The cost-effectiveness and utility of 3 months of cardiac telerehabilitation followed by 9 months of relapse prevention were compared with the cost-effectiveness of traditional center-based cardiac rehabilitation. The analysis included 300 patients with stable coronary artery disease who received care at a CR center serving 2 general hospitals in the Netherlands between May 23, 2016, and July 26, 2018. All patients were entering phase 2 of outpatient CR and were followed up for 1 year (until August 14, 2019). Data were analyzed from September 21, 2020, to September 24, 2021.
Intervention
After baseline measurements were obtained, participants were randomly assigned on a 1:1 ratio to receive CTR (intervention group) or center-based CR (control group) using computerized block randomization. After 6 supervised center-based training sessions, patients in the intervention group continued training at home using a heart rate monitor and accelerometer. Patients uploaded heart rate and physical activity data and discussed their progress during a weekly video consultation with their physical therapist. After 3 months, weekly coaching was concluded, and on-demand coaching was initiated for relapse prevention; patients were instructed to continue using their wearable sensors and were contacted in cases of nonadherence to the intervention or reduced exercise or physical activity volumes.
Main Outcomes and Measures
Quality-adjusted life-years were assessed using the EuroQol 5-Dimension 5-Level survey (EQ-5D-5L) and the EuroQol Visual Analogue Scale (EQ-VAS), and cardiac-associated health care costs and non–health care costs were measured by health care consumption, productivity, and informal care questionnaires (the Medical Consumption Questionnaire, the Productivity Cost Questionnaire, and the Valuation of Informal Care Questionnaire) designed by the Institute for Medical Technology Assessment. Costs were converted to 2020 price levels (in euros) using the Dutch consumer price index (to convert to US dollars, euro values were multiplied by 1.142, which was the mean exchange rate in 2020).
Results
Among 300 patients (266 men [88.7%]), the mean (SD) age was 60.7 (9.5) years. The quality of life among patients receiving CTR vs center-based CR was comparable during the study according to the results of both utility measures (mean difference on EQ-5D-5L: −0.004; P = .82; mean difference on EQ-VAS: −0.001; P = .92). Intervention costs were significantly higher for CTR (mean [SE], €224 [€4] [4)]) compared with center-based CR (mean [SE], €156 [€5] [6)]; P < .001); however, no difference in overall cardiac health care costs was observed between CTR (mean [SE], €4787 [€503] [574)] and center-based CR (mean [SE], €5507 [€659] [753)]; P = .36). From a societal perspective, CTR was associated with lower costs compared with center-based CR (mean [SE], €20 495 [€ 2751] [3142)] vs €24 381 [€3613] [4126)], respectively), although this difference was not statistically significant (−€3887 [−$4439]; P = .34).
Conclusions and Relevance
In this economic evaluation, a CTR intervention with relapse prevention was likely to be cost-effective compared with center-based CR, suggesting that CTR maybe used as an alternative intervention for the treatment of patients with coronary artery disease. These results add to the evidence base in favor of CTR and may increase the implementation of CTR interventions in clinical practice.
Background
Cognitive behavioral therapy is known to improve the management of chronic pain. However, the components of this therapy are still being investigated and debated.
Objective
This study aimed to examine the effectiveness of an integrated cognitive behavioral therapy program with new components (attention-shift, memory work, video feedback, and image training) delivered via videoconferencing.
Methods
This study was unblinded and participants were recruited and assessed face-to-face in the outpatient department. We conducted a randomized controlled trial for chronic pain to compare 16 weekly videoconference-based cognitive behavioral therapy (vCBT) sessions provided by a therapist with treatment as usual (TAU). Thirty patients (age range, 22-75 years) with chronic pain were randomly assigned to either vCBT (n=15) or TAU (n=15). Patients were evaluated at week 1 (baseline), week 8 (midintervention), and week 16 (postintervention). The primary outcome was the change in pain intensity, which was recorded using the numerical rating scale at 16 weeks from the baseline. Secondary outcomes were pain severity and pain interference, which were assessed using the Brief Pain Inventory. Additionally, we evaluated disability, pain catastrophizing cognition, depression, anxiety, quality of life, and cost utility.
Results
In the eligibility assessment, 30 patients were eventually randomized and enrolled; finally, 15 patients in the vCBT and 14 patients in the TAU group were analyzed. Although no significant difference was found between the 2 groups in terms of changes in pain intensity by the numerical rating scale scores at week 16 from baseline (P=.36), there was a significant improvement in the comprehensive evaluation of pain by total score of Brief Pain Inventory (–1.43, 95% CI –2.49 to –0.37, df=24; P=.01). Further, significant improvement was seen in pain interference by using the Brief Pain Inventory (–9.42, 95% CI –14.47 to –4.36, df=25; P=.001) and in disability by using the Pain Disability Assessment Scale (–1.95, 95% CI –3.33 to –0.56, df=24; P=.008) compared with TAU. As for the Medical Economic Evaluation, the incremental cost-effectiveness ratio for 1 year was estimated at 2.9 million yen (about US $25,000) per quality-adjusted life year gained.
Conclusions
The findings of our study suggest that integrated cognitive behavioral therapy delivered by videoconferencing in regular medical care may reduce pain interference but not pain intensity. Further, this treatment method may be cost-effective, although this needs to be further verified using a larger sample size.
Trial Registration
University Hospital Medical Information Network UMIN000031124; https://tinyurl.com/2pr3xszb
Background
Using technology to reduce the pressure on the National Health Service (NHS) in England and Wales is a key government target, and the NHS Long-Term Plan outlines a strategy for digitally enabled outpatient care to become mainstream by 2024. In 2020, the COVID-19 response saw the widespread introduction of remote consultations for patient follow-up, regardless of individual preferences. Despite this rapid change, there may be enduring barriers to the effective implementation of remote appointments into routine practice once the unique drivers for change during the COVID-19 pandemic no longer apply, to which pre-COVID implementation studies can offer important insights.
Objective
This study aims to evaluate the feasibility of using real-time remote consultations between patients and secondary care physicians for routine patient follow-up at a large hospital in the United Kingdom and to assess whether patient satisfaction differs between intervention and usual care patients.
Methods
Clinically stable liver transplant patients were randomized to real-time remote consultations in which their hospital physician used secure videoconferencing software (intervention) or standard face-to-face appointments (usual care). Participants were asked to complete postappointment questionnaires over 12 months. Data were analyzed on an intention-to-treat basis. The primary outcome was the difference in scores between baseline and study end by patient group for the three domains of patient satisfaction (assessed using the Visit-Specific Satisfaction Instrument). An embedded qualitative process evaluation used interviews to assess patient and staff experiences.
Results
Of the 54 patients who were randomized, 29 (54%) received remote consultations, and 25 (46%) received usual care (recruitment rate: 54/203, 26.6%). The crossover between study arms was high (13/29, 45%). A total of 129 appointments were completed, with 63.6% (82/129) of the questionnaires being returned. Patient satisfaction at 12 months increased in both the intervention (25 points) and usual care (14 points) groups. The within-group analysis showed that the increases were significant for both intervention (P<.001) and usual care (P=.02) patients; however, the between-group difference was not significant after controlling for baseline scores (P=.10). The qualitative process evaluation showed that—according to patients—remote consultations saved time and money, were less burdensome, and caused fewer negative impacts on health. Technical problems with the software were common, and only 17% (5/29) of patients received all appointments over video. Both consultants and patients saw remote consultations as positive and beneficial.
Conclusions
Using technology to conduct routine follow-up appointments remotely may ease some of the resource and infrastructure challenges faced by the UK NHS and free up clinic space for patients who must be seen face-to-face. Our findings regarding the advantages and challenges of using remote consultations for routine follow-ups of liver transplant patients have important implications for service organization and delivery in the postpandemic NHS.
Trial Registration
ISRCTN Registry 14093266; https://www.isrctn.com/ISRCTN14093266
International Registered Report Identifier (IRRID)
RR2-10.1186/s13063-018-2953-4
Background
Patient‐reported outcome measures (PROMs) are questionnaires that collect health outcomes directly from the people who experience them. This review critically synthesizes information on generic and selected condition‐specific PROMs to describe trends and contemporary issues regarding their development, validation and application.
Methods
We reviewed academic and grey literature on validated PROMs by searching databases, prominent websites, Google Scholar and Google Search. The identification of condition‐specific PROMs was limited to common conditions and those with a high burden of disease (eg cancers, cardiovascular disorders). Trends and contemporary issues in the development, validation and application of PROMs were critically evaluated.
Results
The search yielded 315 generic and condition‐specific PROMs. The largest numbers of measures were identified for generic PROMs, musculoskeletal conditions and cancers. The earliest published PROMs were in mental health‐related conditions. The number of PROMs grew substantially between 1980s and 2000s but slowed more recently. The number of publications discussing PROMs continues to increase. Issues identified include the use of computer‐adaptive testing and increasing concerns about the appropriateness of using PROMs developed and validated for specific purposes (eg research) for other reasons (eg clinical decision making).
Conclusions
The term PROM is a relatively new designation for a range of measures that have existed since at least the 1960s. Although literature on PROMs continues to expand, challenges remain in selecting reliable and valid tools that are fit‐for‐purpose from the many existing instruments.
Patient or public contribution
Consumers were not directly involved in this review; however, its outcome will be used in programmes that engage and partner with consumers.
Objective
: Pediatric asthma is a major public health concern, considering its chronic nature and negative effects on quality of life of affected children. Telemedicine is efficacious in providing pharmaceutical care for patients with several chronic diseases, including asthma. This approach allows habitants of sparsely populated rural Jordanian areas to remotely access high-quality healthcare services. Pharmacist-provided asthma counseling has proven benefits in improving patient adherence rates and their understanding. This study evaluated clinical and economic impacts of pharmacist-led, interactive synchronous telemedicine counseling of pediatric asthma patients in Jordan.
Methods
: A randomized, controlled, 12-week pre-post interventional study was conducted. Ninety patients with uncontrolled asthma aged 5-11 years were recruited and randomly assigned to two groups: intervention or control. Inhaler use was checked for both groups at baseline, along with assessment of clinical and economic measures. Counseling on proper inhaler use was provided by pharmacists. Telemedicine sessions for the intervention group were scheduled every 4 weeks, whereas the control group received standard care. Pertinent measures reflecting the level of disease control and relapse were tracked monthly. Results: The intervention group showed more significant improvement in clinical and economic outcomes than the control group (the Childhood Asthma Control Test mean scores [P = 0.0134], decreased parental loss of wages [P = 0.0015], and decreased economic burden [P < 0.001]). Additionally, overall improvement in quality of life and satisfaction with the telemedicine sessions were reported.
Conclusion
: Pharmacist-led telemedicine counseling could be a promising approach to deliver distant pharmaceutical care for patients with childhood asthma.
Study Objective: Telemedicine (TM) for continuous positive airway pressure (CPAP) treated patients may save health-care resources without compromising treatment effectiveness. We assessed the effect of TM (AirView Online System, ResMed) during the CPAP habituation phase on 3-month and 1-year treatment adherence and efficacy in patients with moderate-to-severe obstructive sleep apnea (OSA).
Methods: At CPAP initiation, 120 patients diagnosed with OSA were randomized to either usual care (UC) or TM during the habituation phase (clinical registration: ISRCTN12865936). Both groups received a first face-to-face appointment with a sleep care giver at CPAP initiation. Within the following month, 2 other physical visits were scheduled in the UC group whereas two phone consultations were planned in the TM group, in which CPAP parameters were remotely adapted. Additional physical visits were programmed at the patient's request. Face-to-face consultations were scheduled at 3 and 12 months after CPAP initiation. The primary outcome was the mean CPAP daily use over the course of 12 months.
Results: Twenty of 60 patients stopped CPAP therapy in the UC group vs. 14 of 60 in the TM group ( p = 0.24). In per protocol analysis, mean [95% CI] daily CPAP use among 86 patients still using CPAP at 12 months was 279 [237; 321] min in the 38 patients on UC and 279 [247; 311] min in the 43 patients on TM, mean difference [95% CI]: 0 [−52; 52] min, P = 0.99. Total consultation time per patient was not different between groups, TM: 163 [147; 178] min, UC: 178 [159; 197] min, difference: −15 [−39; 9] min, p = 0.22.
Conclusions: Telemedicine during the CPAP habituation phase did not alter daily CPAP use or treatment adherence and did not require more healthcare time. Telemedicine may support clinic attendance for CPAP titration.
Clinical Trial Registration: [ISRCTN], identifier [ISRCTN12865936].
Non-adherence after heart transplantation (HTx) is a significant problem. The main objective of this study was to evaluate if a mHealth strategy is more effective than standard care in improving adherence and patients’ experience in heart transplant recipients. Methods: This was a single-center, randomized controlled trial (RCT) in adult recipients >1.5 years post-HTx. Participants were randomized to standard care (control group) or to the mHeart Strategy (intervention group). For patients randomized to the mHeart strategy, multifaceted theory-based interventions were provided during the study period to optimize therapy management using the mHeart mobile application. Patient experience regarding their medication regimens were evaluated in a face-to-face interview. Medication adherence was assessed by performing self-reported questionnaires. A composite adherence score that included the SMAQ questionnaire, the coefficient of variation of drug levels and missing visits was also reported. Results: A total of 134 HTx recipients were randomized (intervention N = 71; control N = 63). Mean follow-up was 1.6 (SD 0.6) years. Improvement in adherence from baseline was significantly higher in the intervention group versus the control group according to the SMAQ questionnaire (85% vs. 46%, OR = 6.7 (2.9; 15.8), p-value < 0.001) and the composite score (51% vs. 23%, OR = 0.3 (0.1; 0.6), p-value = 0.001). Patients’ experiences with their drug therapy including knowledge of their medication timing intakes (p-value = 0.019) and the drug indications or uses that they remembered (p-value = 0.003) significantly improved in the intervention versus the control group. Conclusions: In our study, the mHealth-based strategy significantly improved adherence and patient beliefs regarding their medication regimens among the HTx population. The mHeart mobile application was used as a feasible tool for providing long-term, tailor-made interventions to HTx recipients to improve the goals assessed.
Telehealth systems have shown success in the remote management of several neurological disorders, but there is a paucity of evidence in disorders of consciousness (DOC). In this study, we explore the effectiveness of a new telemonitoring system, for monitoring Vegetative State (VS) and Minimally Conscious State (MCS) patients. This was a prospective, mono-center randomized controlled study. We included only traumatic brain injury (TBI) patients who required long-term motor/cognitive assistance having a stable clinical condition. We examined their clinical evolution over ~4 years of the follow-up period. Twenty-two TBI patients were enrolled and equally divided into two groups: one telemonitored at home with our service and the second admitted to a standard long-stay hospitalization (LSH) program. Patients enrolled in the telehealth service (age: 49.9 ± 20.4; 45% female; diagnosis: 36% VS/64% MCS) were demographically and clinically-matched with those admitted to the LSH program (age: 55.1 ± 15; 18% female; diagnosis: 54% VS/46% MCS). Thirty-six percent of patients in the LSH program died before completing follow up evaluation with respect to 18% of death in the group of TBI patients telemonitored at home. At follow-up, patients in LSH and telemonitoring groups showed similar clinical progression, as measured by CRS-r, NCS, WHIM, and LCF scales, as well as by the number of medical complications (i.e., bedsores, infections). Finally, we estimated the total daily cost per patient. Severe TBI patients enrolled in the conventional LSH program cost 262€ every single day, whereas the cost per patient in the telehealth service resulted to be less expensive (93€). Here, we highlight that our telehealth monitoring service is as efficacious as in-person usual care to manage a severe neurological disorder such as TBI in a cost-effective way.
Aim
Live two‐way video, easily accessible from home via smartphones and other devices, is becoming a new way of providing psychiatric treatment. However, lack of evidence for real‐world clinical setting effectiveness hampers its approval by medical insurance in some countries. Here, we conducted the first large‐scale pragmatic, randomized controlled trial to determine the effectiveness of long‐term treatment for multiple psychiatric disorders via two‐way video using smartphones and other devices, which are currently the primary means of telecommunication.
Methods
This randomized controlled trial compared two‐way video versus face‐to‐face treatment for depressive disorder, anxiety disorder, and obsessive‐compulsive disorder in the subacute/maintenance phase during a 24‐week period. Adult patients with the above‐mentioned disorders were allocated to either a two‐way video group (≥50% video sessions) or a face‐to‐face group (100% in‐person sessions) and received standard treatment covered by public medical insurance. The primary outcome was the 36‐Item Short‐Form Health Survey Mental Component Summary (SF‐36 MCS) score. Secondary outcomes included all‐cause discontinuation, working alliance, adverse events, and the severity rating scales for each disorder.
Results
A total of 199 patients participated in this study. After 24 weeks of treatment, two‐way video treatment was found to be noninferior to face‐to‐face treatment regarding SF‐36 MCS score (48.50 vs 46.68, respectively; p < 0.001). There were no significant differences between the groups regarding most secondary end points, including all‐cause discontinuation, treatment efficacy, and satisfaction.
Conclusion
Two‐way video treatment using smartphones and other devices, was noninferior to face‐to‐face treatment in real‐world clinical settings. Modern telemedicine, easily accessible from home, can be used as a form of health care.
Objective
To undertake an economic evaluation of a telehealth psychological support intervention for patients with primary brain tumor (PBT).
Methods
A within‐trial cost‐utility analysis over 6 months was performed comparing a tailored telehealth‐psychological support intervention with standard care (SC) in a randomized control trial. Data were sourced from the Telehealth Making Sense of Brain Tumor (Tele‐MAST) trial survey data, project records, and administrative healthcare claims. Quality‐adjusted life years (QALYs) were calculated based on the EuroQol‐5D‐5L. Non‐parametric bootstrapping with 2000 iterations was used to determine sampling uncertainty. Multiple imputation was used for handling missing data.
Results
The Tele‐MAST trial included 82 participants and was conducted in Queensland, Australia during 2018–2021. When all healthcare claims were included, the incremental cost savings from Tele‐MAST were ‐AU8637, −50,000 per QALY gain. When psychological‐related healthcare costs were included only, the incremental cost per QALY gain was AU24,566) and net monetary benefits were AU466, $602) with a 65% likelihood of the intervention being cost‐effective.
Conclusions
Based on this small randomized controlled trial, the Tele‐MAST intervention is a cost‐effective intervention for improving the quality of life of people with PBT in Australia. Patients receiving the intervention incurred significantly lower overall healthcare costs than patients in SC. There was no significant difference in costs incurred for psychological health services.
Objective: In middle-aged individuals with early-stage knee osteoarthritis (OA), follow-up with remote rehabilitation methods may provide effective clinical outcomes. The present study aimed to investigate the effect of telerehabilitation (TR) on pain, function, performance, strength, proprioception, and psychosocial parameters in patients with knee OA.
Design: A randomized controlled study was conducted with 54 participants with knee OA. All patients were randomized into two groups: the home-based telerehabilitation group (TRG) (n=29) and the home-based paper group (PG) (n=28). The home exercise program and training were provided with an instruction manual to PG. The same home exercise and education prescriptions were given to individuals in TRG via an online platform. Pain, function, quality of life, physical performance, muscle strength, and proprioception were evaluated at baseline and after eight weeks of intervention. In addition, satisfaction and usability were evaluated at week 8.
Results: TRG demonstrated better improvement in terms of pain, function, quality of life index score, and left extremity proprioception (p<0.05). TRG was not superior to PG in terms of muscle strength and performance tests (except the Five Times Sit to Stand Test) (p>0.05).
Conclusions: The home-based TR program was superior to the home-based PG program for pain, function, quality of life, and proprioception in patients with knee OA.
Rationale:
Positive airway pressure (PAP) is standard treatment for obstructive sleep apnea (OSA). Telemedicine has been introduced for improved PAP follow-up.
Objective:
Our study aim was to evaluate clinical utility and patient satisfaction of PAP follow-up with an early intervention telemedical protocol.
Methods:
Randomized, controlled trial conducted at four sleep clinics of the same county. Treatment naive OSA patients were randomized to standard PAP follow-up (203 patients, fixed follow-up procedures) or early intervention telemedical follow-up (Air View, ResMed; 206 patients, continuous follow-up) for 3 months. Evaluated variables included PAP adherence at 3 months, patient-related outcome measures (Epworth Sleepiness Scale, Short Form 36, Insomnia Severity Scale, Hospital Anxiety and Depression Scale), and staff time. Group differences were analyzed with linear mixed regression models adjusted for age, Body Mass Index (BMI) and Apnea Hypopnea Index, and study center.
Results:
The study groups were comparable at baseline (N=409, mean age 59±12 years, BMI 31.9±6 kg/m2, AHI 41.5±21 n/h). PAP adherence was higher in the proactive telemedicine compared with the control group (4.3±2.4 and 4.1±2.6 hours/night, P=0.01, respectively) and mean mask pressure at follow-up was significantly lower in the telemedicine group, 8.7 ±2.1 cm/H20 compared to 9.2cm±2.5 cm/H20 in the control group (p=0.028). In post-hoc analysis the difference was most pronounced in patients with depression (4.8±2.6 vs 2.7±2.3 hours/night, p=0.03). Relevant mask leakage (>24 l/min) was lower in the telemedicine group (N=5.4% versus N=12.1%, P=0.024, respectively). Improvement of patient related outcome measures and patient satisfaction were equivalent between groups.
Conclusions:
Proactive telemedical management of the initial follow-up of PAP treatment compared favorably to conventional follow-up in terms of adherence, pressure level, and mask leakage. Patients with depression may particularly benefit from telemedical follow-up. Specific clinical routines are required to establish this practice in sleep clinics.
Clinicaltrials:
gov NCT03446560.
Introduction:
Patients with systemic lupus erythematous were vulnerable to severe coronavirus disease 2019 infection and the negative impact of disrupted healthcare delivery. Telemedicine has been a popular alternative to standard in-person care during the pandemic despite the lack of evidence.
Methods:
This was a 1-year pragmatic randomized-controlled trial. Patients followed at the lupus nephritis clinic were randomized to either telemedicine or standard follow-up in a 1:1 ratio. Patients in the telemedicine group were followed up via videoconferencing. Standard follow-up group patients continued conventional in-person outpatient care. The primary outcome of the study was the proportion of patients in low disease activity after 1 year. Secondary outcomes included cost-of-illness, safety, and various patient-reported outcomes.
Results:
From 6/2020 to 12/2021, 144 patients were randomized and 141 patients (telemedicine: 70, standard follow-up: 71) completed the study. At 1 year, 80.0% and 80.2% of the patients in the telemedicine group and standard follow-up group were in lupus low disease activity state or complete remission, respectively (p = 0.967). Systemic lupus erythematous disease activity indices, number of flares and frequency of follow-ups were also similar. There were no differences in the cost-of-illness, quality of life or mental health scores. However, significantly more patients in the telemedicine group (41.4% vs 5.6%; p < 0.001) required switch of mode of follow-up and higher proportion of them had hospitalization during the study period (32.9% vs 15.5%; p = 0.016). Being in the telemedicine group or not in low disease activity at baseline were the independent predictors of hospitalization (odds ratio: 2.6; 95% confidence interval: 1.1-6.1, odds ratio: 2.7, 95% confidence interval: 1.1-6.7, respectively) in the post hoc analysis.
Conclusions:
In patients with systemic lupus erythematous, telemedicine predominant follow-up resulted in similar 1-year disease control compared to standard care. However, it needed to be complemented by in-person visits, especially in patients with unstable disease.
Background:
In the course of the corona pandemic, digital media has increasingly been used in many areas of medical practice to reduce personal contact. As it is of interest whether this can be practiced in the context of anesthesia consultations without loss of quality, we interviewed parents whose children received a cardiac or neuro magnetic resonance imaging (MRI) under sedation. Parents either received an on-site or a remote consultation conducted by an anesthesiologist. Both parents and anesthesiologist were asked to indicate their satisfaction with the respective consultation procedure in a questionnaire.
Aim:
The aim of this study was to investigate if remote pre-anesthesia consultation, supported by an online video, for parents whose children are receiving MRI examinations under sedation can replace the commonly performed on-site consultation, without decreasing its quality.
Methods:
In this randomized trial, a total of 200 patients were included, one half received pre-anesthesia consultation on-site and the other half was given a link to a video and pre-anesthesia consultation was conducted by phone. As a primary analysis, we compared the level of satisfaction for the general procedure, the quality of the pre-anesthesia consultation and the contact to the anesthesiologists (or parents). We further investigated the frequency of complications and the preference for a possible next informed consent.
Results:
Both groups showed high levels of satisfaction. Some anesthesiologists and parents were less satisfied with the quality of on-site pre-anesthesia consultation than with the remote. In our patient cohort, there was no evidence for higher risk of complications when information was provided by telephone. Further, parents as well as anesthesiologists clearly favored the combined form of telephone information and online video. Overall, 61.2% of parents and 64% of anesthesiologists would choose this form of pre-anesthesia consultation for repeat anesthesia.
Conclusions:
We did not observe that combined telephone and video decreased the quality of pre-anesthesia consultation. A remote version seems feasible for simple procedures such as sedation for MRI. Further research on this topic in other areas of anesthesia would be beneficial.
There is a need to better understand the role of postoperative care via telemedicine (TM). We evaluated patient satisfaction and outcomes of postoperative face-to-face (F2F) versus TM visits for adult ambulatory urological surgeries in an urban academic center. Methods:This was a prospective, randomized controlled trial. At surgery, patients undergoing ambulatory endoscopic procedures or open surgery were randomized 1:1 to a postoperative F2F or TM visit. After the visit, a telephone survey assessing satisfaction was administered. Primary outcome was patient satisfaction; secondary outcomes were time and cost savings, and 30-day safety outcomes. Results:A total of 197 patients were approached; 165 (83%) consented and were randomized-76 (45%) to F2F and 89 (54%) to TM cohorts. There were no significant differences in baseline demographics between the cohorts. Both cohorts were equally satisfied with their postoperative visit (F2F 98.6% vs TM 94.1%, p=0.28) and found their visit to be an acceptable form of health care (F2F 100% vs TM 92.7%, p=0.06). The TM cohort saved a significant amount of time (TM 66.2% spent <15 minutes vs F2F 43.1% spent 1-2 hours, p <0.0001) and money (44.1% TM saved 25 vs 43.1% F2F spent 25, p=0.041) associated with travel. There were no significant differences in 30-day safety outcomes between the cohorts. Conclusions:TM for postoperative visits after ambulatory adult urological surgery saves patients time and money without compromising satisfaction or safety. TM should be offered as an alternative to F2F for routine postoperative care for certain ambulatory urological surgeries.
Objective
Patients and physicians can naturally adopt hybrid healthcare models that combine face-to-face consultations with telemedicine. The study's objective was to compare the impact of two healthcare interventions, hybrid care modality and face-to-face consultation, on the patient-reported outcomes of rheumatoid arthritis patients, during the COVID-19 pandemic.
Methods
Consecutive outpatients reincorporated to a clinic previously in lockdown were invited to a non-inferiority, randomized study (October 2020–-May 2022). Patients were randomized to 6 months of face-to-face consultation or hybrid care modality (intervention period-1) and then the converse modality (intervention period-2). The primary outcome was disease activity/severity behavior (Routine Assessment of Patient Index Data 3). Additional patient-reported outcomes were disability (Health Assessment Questionnaire Disability Index), quality-of-life (World Health Organization quality of life questionnaire-brief version), adherence and satisfaction with medical care, and treatment recommendation. Sample size calculation established 55 patients/healthcare interventions.
Results
There were 138 patients invited to participate, 130 agreed and 121 completed their study participation. Sixty-one and 60 patients respectively, received face-to-face consultation and hybrid care modality over intervention period-1. Patients were primarily middle-aged females (90.1%), with (median, IQR) 12 (9–16) years of education, long-standing disease, working (62.8%), receiving disease-modifying anti-rheumatic drugs (96.7%), and corticosteroids (61.2%). Patients had low disease activity (median Routine Assessment of Patient Index Data 3: 2.7) and Health Assessment Questionnaire Disability Index score that translated into the absence of disability, while quality of life was compromised. Baseline characteristics were similar between patients assigned to each healthcare intervention. Differences in Routine Assessment of Patient Index Data 3 behavior were below the non-inferiority margin. Results considered the order in which patients received the intervention and baselines scores, and extended to the patient-reported outcomes left.
Conclusions
Hybrid care modality was non-inferior to in-person consultations in achieving patient-reported outcomes during the COVID-19 pandemic in rheumatoid arthritis patients.
Background:
Postmenopausal bleeding (PMB), a common symptom of endometrial cancer, necessitates prompt clinical and sonographic assessment, often followed by hysteroscopy. Unfortunately, due to traditional gynaecology outpatient clinic paradigms, unnecessary patient-clinician encounters are common and may lead to delays in diagnosis.
Aim:
The aim was to assess a novel clinic model for the management of women with PMB based on virtual assessment and routine use of the outpatient hysteroscopy clinic.
Methods:
An unblinded pragmatic randomised controlled trial was performed, comparing a 'virtual clinic' to routine outpatient clinical care. The primary outcome for assessment was time, measured as the interval (days) between referral triage and discharge for definitive management or to the general practitioner. Demographical and clinical data were collected. After discharge from the system, patients completed a satisfaction and feedback questionnaire. Log-rank tests were used to compare the equality of time-to-event functions across randomised groups.
Results:
There were 96 participants, 46 in the intervention arm and 50 controls. The total time spent in the gynaecology system differed between groups (Χ2 (1) = 6.94, P = 0.008), with a median total time of 55 days (95% confidence interval (CI): 37-66 days) for the intervention group compared to a median of 84 days (95% CI: 54-101 days) for the control group. The number of in-person gynaecology encounters differed between those randomised to intervention (P < 0.001). Overall, 96% of respondents indicated a positive score for overall satisfaction.
Conclusions:
The proposed clinic model resulted in a significant reduction in the time between referral and discharge, without compromising patient satisfaction.
Objectives. Rheumatoid arthritis (RA) is a prevalent and disabling disease that is the source of significant direct and indirect costs. The current recommended therapeutic strategy is based on the rapid introduction of therapy with conventional Disease-Modifying Anti-Rheumatic Drugs (DMARDs) combined with regular disease monitoring by the rheumatologist. The onerous nature of such intense monitoring has motivated the development of new, less demanding strategies such as telemedicine. This study aimed to estimate the cost-effectiveness of the connected monitoring of RA patients initiating a new DMARD therapy versus conventional monitoring.
Methods. An economic evaluation based on a randomized controlled trial of 89 patients was conducted. The patients in the intervention group (n = 45) were monitored using a connected monitoring interface on a smartphone, while patients in the control group (n = 44) were conventionally monitored. Health outcomes were measured as the gain in quality-adjusted life-years (QALYs), assessed using the EuroQol-5D questionnaire. Resource use and health outcomes were collected alongside the trial and at the six-month follow-up using application data and the related clinical case manager time, visits, hospitalisations, and transport records. These outcomes were valued using externally collected data on unit costs and QALY weights.
Results. Compared to conventionally monitored patients, patients receiving connected monitoring had a slightly greater but not significant gain in the average QALY of 0.07. The economic analysis found that connected monitoring resulted in a significant cost reduction of 72euro (2,927euro vs. 2,999euro, p<0.01). The incremental cost-utility ratio of the intervention was equal to -1,029euro per QALY (95% CI: -32,033; +24,625) with a 97.8% chance of being cost-effective at a threshold of 30,000euro per QALY gained.
Conclusion. Implementing EULAR recommendations for RA patients initiating a DMARD treatment using connected monitoring is more efficient and less expensive than conventional care.
Clinical trial registration number: ClinicalTrials.gov (NCT03005925)
Aims The Virtual Diabetes Outpatient Clinic for Children and Adolescents (VIDIKI) study was a 6-month quasi-randomized, multicentre study followed by an extension phase to evaluate the effects of monthly video consultations in addition to regular care. A health economic analysis was conducted to assess the direct costs.
Methods The cost data of 240 study participants (1–16 years of age) with type 1 diabetes who were already using a continuous glucose monitoring system were collected in the first 6 months of the study. The intervention group (IG) received monthly video consultations plus regular care, and the waiting control group (WG) received only regular care. Cost data were collected for a comparable anonymized group of children from the participating health insurance companies during the 6-month period before the study started (aggregated data group [AG]).
Results Cost data were analysed for the AG (N=840) 6 months before study initiation and those for the study participants (N=225/240). Hospital treatment was the highest cost category in the AG. There was a cost shift and cost increase in the IG and WG, whereby diabetes supplies were the highest cost category. The mean direct diabetes-associated 6-month costs were € 4,702 (IG) and € 4,936 (WG).
Conclusion The cost development within the cost collection period over two years possibly reflects the switch to higher-priced medical supplies. Video consultation as an add-on service resulted in a small but nonsignificant reduction in the overall costs.
Objective To determine the accuracy and reliability of remotely directed and interpreted ultrasound (teleultrasound) as compared with standard in-person ultrasound for the detection of fetal anomalies, and to determine participants' satisfaction with teleultrasound.
Study Design This was a single-center, randomized (1:1) noninferiority study. Individuals referred to the maternal–fetal medicine (MFM) ultrasound clinic were randomized to standard in-person ultrasound and counseling or teleultrasound and telemedicine counseling. The primary outcome was major fetal anomaly detection rate (sensitivity). All ultrasounds were performed by registered diagnostic medical sonographers and interpretations were done by a group of five MFM physicians. After teleultrasound was completed, the teleultrasound patients filled out a satisfaction survey using a Likert scale. Newborn data were obtained from the newborn record and statewide birth defect databases.
Results Of 300 individuals randomized in each group, 294 were analyzed in the remotely interpreted teleultrasound group and 291 were analyzed in the in-person ultrasound group. The sensitivity of sonographic detection of 28 anomalies was 82.14% in the control group and of 20 anomalies in the telemedicine group, it was 85.0%. The observed difference in sensitivity was 0.0286, much smaller than the proposed noninferiority limit of 0.05. Specificity, negative predictive value, positive predictive value, and accuracy were more than 94% for both groups. Patient satisfaction was more than 95% on all measures, and there were no significant differences in patient satisfaction based on maternal characteristics.
Conclusion Teleultrasound is not inferior to standard in-person ultrasound for the detection of fetal anomalies. Teleultrasound was uniformly well received by patients, regardless of demographics. These key findings support the continued expansion of telemedicine services.
Key Points
Background:
This study aims to explore the effect of mobile phone-based telemedicine management of glycemic control of type 2 diabetes mellitus (T2DM).
Methods:
Patients with T2DM were followed up in Chongqing Jiulongpo District Yuzhoulu Community Health Center, and randomly divided into the telemedicine group (n=47) and the control group (n=50). The control group received regularly routine intervention. The telemedicine management group used the mobile phone to manage their health condition remotely.
Results:
Both groups had similar baseline characteristics. After a follow-up period of 12 months intervention, the weight, body mass index, waist circumference, systolic blood pressure, body fat percentage, body fat mass, body water and muscle mass, fasting blood glucose, glycosylated hemoglobin, total costs of diabetes treatment for 1 month and the quality-of-life score were significantly improved in the telemedicine group (P<0.05). And compared with the control group, body fat composition, fasting blood glucose, glycosylated hemoglobin and the cost of change shows a significant improvement (P<0.05). Positive correlation was detected between fasting blood glucose and body composition parameters, such as body fat percentage, lean body mass and body fat mass in the telemedicine group (r=0.56, P<0.05; r=0.37, P<0.05; r=0.56, P<0.05).
Conclusions:
Compared with conventional intervention, the mobile phone-based telemedicine management can help patients with diabetes to improve glycemic level and quality of life.
Objective
The aim of this study was to investigate parent and therapist experience and cost savings from the payer perspective associated with a novel tele-physiatry program for children living in rural and underserved communities.
Design
We designed a non-inferiority, cluster-randomized crossover study at four school-based clinics to evaluate parent experience and perceived quality of care between a telemedicine-based approach in which the physiatrist conducts the visit remotely with an in-person therapist and a traditional in-person physiatrist clinic.
Results
A total of 268 encounters (124 telemedicine and 144 in-person) were completed by 200 unique patients. For parents and therapists, experience and perceived quality of care were high with no significant differences between telemedicine and in-person encounters. For parents whose children received a telemedicine encounter, 54.8% reported no preference for their child's subsequent encounter, 28.8% preferred a physiatrist telemedicine visit, and 16.4% preferred a physiatrist in-person visit. From the payer perspective, costs were 100 per clinic to the payer.
Introduction and hypothesisThe objective was to assess whether telemedicine-based follow-up is equivalent to office-based follow-up in the early postoperative period after routine synthetic midurethral sling placement.Methods
This is a prospective, international, multi-institutional, randomized controlled trial. Patients undergoing synthetic midurethral sling placement were randomized to 3-week postoperative telemedicine versus office-based follow-up. The primary outcome was the rate of unplanned events. Secondary outcomes included patient satisfaction, crossover from telemedicine to office-based follow-up, and compliance with 3- to 5-month office follow-up.ResultsWe included 238 patients (telemedicine: 121 vs office: 117). No differences in demographics or medical comorbidities were noted between the study groups (p = 0.09–1.0). No differences were noted in unplanned events: hospital admission, emergency department visit, or unplanned office visit or call (14% vs 12.9%, p = 0.85) or complications (9.9% vs 8.6%, p = 0.82). Both groups were equally “very satisfied” with their surgical outcomes (71.1% vs 69%, p = 0.2). Telemedicine patients were more compliant with 3- to 5-month office follow-up (90.1% vs 79.3%, p = 0.04).Conclusions
After synthetic midurethral sling placement, telemedicine follow-up is a safe patient communication option in the early postoperative period. Telemedicine patients reported no difference in satisfaction compared with office-based follow-up but had greater compliance with 3- to 5-month follow-up.
Background
Telemedicine has shown promising results in the follow up of patients with inflammatory bowel disease. This study compared quality of life and disease activity in patients with inflammatory bowel disease monitored using a telemedicine platform versus standard care.
Methods
In this prospective multicenter study, patients with active inflammatory bowel disease were randomized to EasyMICI–MaMICI® telemedicine platform or standard care. The main objective was to assess the efficacy of the software platform, as measured by quality of life and quality of care. Secondary outcomes were changes in the use of healthcare resources, and patient satisfaction in the MaMICI group.
Results
Fifty-four patients were enrolled (November 2017–June 2018); 59.3% had Crohn’s disease and 40.7% ulcerative colitis. Forty-two patients received biologics at inclusion. After 12 months, a significant improvement in quality of life was observed with MaMICI versus standard care, with mean (standard deviation) changes from baseline of 14.8 (11.8) vs 6.3 (9.7) in the SIBDQ scores and 18.5 (18.7) vs 2.4 (8.3) in the EuroQol 5 D-3L questionnaire scores (both p ≤ .02). Disease activity was similar in both treatment groups. Use of MaMICI slightly reduced healthcare utilization versus controls (mean gastroenterologist consultations 2.2 vs 4.1; p = .1308). Overall satisfaction with MaMICI was high (mean score 7/10), and 46.2% of remaining patients in the MaMICI group continued to use the platform until 12 months.
Conclusion
Significant improvement in quality of life and overall satisfaction with this telemedicine platform, indicates that further evaluation of EasyMICI–MaMICI in larger numbers of patients with inflammatory bowel disease is warranted.