Telemonitoring with TECCU of active Inflammatory Bowel Disease is Not Inferior to Standard Care: Short-term Results of a Multicentre Randomized Controlled Trial of GETECCU.

BACKGROUND: Telemonitoring is not consistently superior to standard care for inflammatory bowel disease (IBD), yet non-inferiority may be an acceptable outcome if remote care is more efficient. OBJECTIVE: To compare the remission time and quality of life of patients with an active IBD controlled by standard care or through the TECCU App (Telemonitoring of Crohn´s Disease and Ulcerative Colitis). METHODS: A 2-arm, randomized, multicentre trial with a non-inferiority design was performed at 24 Spanish hospitals on adult patients with IBD who initiated immunosuppressant or biological therapy. Patients were randomized into telemonitoring (G_TECCU) or standard care groups (G_Control). The follow-up schedule was based on telemonitoring contacts through the TECCU App in G_TECCU, and on in-person visits and telephone calls in G_Control, as in clinical practice. In both groups, treatment was adjusted according to the evolution of disease activity and medication adherence, which were measured through specific indices and biological markers at each check-up. The primary outcome was time in remission after 12-weeks, with quality of life, medication adherence, adverse events and patient satisfaction as secondary outcomes. RESULTS: Of 169 patients enrolled, 158 were randomized, and 150 were analyzed per protocol: telemonitoring (n=71); control (n=79). After 12-week, the time in clinical remission was not inferior after telemonitoring (4.20 ±3.73 weeks) to that in the controls (4.32 ±3.28 weeks), with a mean difference between arms of -0.12 weeks (95% CI -1.25-,1.01), non-inferiority p=0.017). The mean reduction of CRP values was -15.40 mg/L (SD=90.15, P =0.195) in G_TECCU and -13.16 mg/L (SD=54.61, P =0.053) in G_control, without significant differences between the two arms (P=.726). Similarly, the mean improvement of FC levels was 832.3 mg/L (SD=1825.0, P=.003) in G_TECCU and 1073.5 mg/L in G_Control (SD=3105.7, P=.03), but differences were not significant (P=.965). Quality of life improved in both groups, with a mean rise in the IBDQ-9 score of 13.44 points in G_TECCU (SD=19.1; P<.001) and 18.23 points [SD=22.9]; P=.001) in G_Control. Moreover, the proportion of patients who adhered to their medication rose significantly from 35.2% (25/71) to 67.6% (48/71) in G_TECCU (P=.001) and from 45.6% (36/79) to 73.4% (58/79) in G_Control (P=.001). Satisfaction remained stable around 90%, although non-inferiority was not demonstrated for secondary outcomes. CONCLUSIONS: Telemonitoring patients with active IBD is not inferior to standard care to achieve and maintain short-term remission. TECCU may be an alternative follow-up tool if the improved health outcomes and costs are confirmed in the long-term. CLINICALTRIAL: The trial is registered at ClinicalTrials.gov with the identifier NCT06031038; https://classic.clinicaltrials.gov/ct2/show/NCT06031038. INTERNATIONAL REGISTERED REPORT: RR2-10.2196/resprot.9639.

Association between Chronotype, Physical Activity and Sedentary Behaviour: A Systematic Review.

BACKGROUND: The aim of this systematic review is to compile and assess the scientific evidence about the relationship between chronotypes and physical activity (PA). Methods: A systematic review was executed using a structured electronic search in PubMED, Cochrane Library, PsycInfo and Trip Database. The searches employed keywords such as chronotype, sleep, acrophase, chronotype preference, morningness, physical activity and sedentary, using MeSH terms. JBI critical tools were used to appraise methodological aspects. RESULTS: This systematic review includes 23 studies and a total of 505,375 participants. The results show that evening chronotypes are associated with less PA and more time in sedentary activities. It occurs independently of the instruments used to collect information about chronotype and PA. Nevertheless, this association could be mitigated in young populations and university stages. CONCLUSIONS: The chronotypes are clearly associated with the PA level and the sedentary behaviour, especially in the population over their mid-twenties. Evening chronotypes are associated with less PA and more time in sedentary activities compared to morning chronotypes.

Empowering Patients Living With Chronic Conditions Using Video as an Educational Tool: Scoping Review.

BACKGROUND: Video is used daily for various purposes, such as leisure, culture, and even learning. Currently, video is a tool that is available to a large part of the population and is simple to use. This audio-visual format has many advantages such as its low cost, speed of dissemination, and possible interaction between users. For these reasons, it is a tool with high dissemination and educational potential, which could be used in the field of health for learning about and management of chronic diseases by adult patients. OBJECTIVE: The following review determines whether the use of health educational videos by adult patients with chronic diseases is effective for their self-management according to the literature. METHODS: An electronic literature search of the PubMed, CINAHL, and MEDLINE (via the EBSCOhost platform) databases up to April 2020 was conducted. The systematic scoping review followed the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) methodology. RESULTS: After reviewing 1427 articles, 12 were selected as the most consistent with the proposed inclusion criteria. After their review, it was found that the studies showed that video is effective as a tool for improving care related to chronic diseases. CONCLUSIONS: Video is effective in improving the care and quality of life for patients with chronic diseases, whether the initiative for using video came from their health care professionals or themselves.

Economic Evaluation in Neurological Physiotherapy: A Systematic Review.

This systematic review was carried out to compile and assess original studies that included economic evaluations of neurological physiotherapy interventions. A thorough search of PubMED, Cochrane and Embase was developed using keywords such as health economics, neurological physiotherapy and cost analysis, and studies published during the last six-year term were selected. A total of 3124 studies were analyzed, and 43 were eligible for inclusion. Among the studies analyzed, 48.8% were interventions for stroke patients, and 13.9% were focused on Parkinson's disease. In terms of the countries involved, 46.5% of the studies included were developed in the UK, and 13.9% were from the USA. The economic analysis most frequently used was cost-utility, implemented in 22 of the studies. A cost-effectiveness analysis was also developed in nine of those studies. The distribution of studies including an economic evaluation in this discipline showed a clear geographic dominance in terms of the pathology. A clear upward trend was noted in the economic evaluation of interventions developed in neurological physiotherapy. However, these studies should be promoted for their use in evidence-based clinical practice and decision-making.

Impact of Seasonality on Physical Activity: A Systematic Review.

BACKGROUND: The purpose of this study was to collect and analyze the available scientific evidence of the impact of seasonality on physical activity (PA). PA refers to walking, biking, sports and/or active recreation. METHODS: The search was performed in the following databases: PubMed, PEDro, Cochrane and Embase. All publications from January 2015 to September 2020 assessing seasonal variations on physical activity development in adults were selected. RESULTS: A total of 1159 articles were identified, of which 26 fulfilled the selection criteria involving 9300 participants from 18 different countries. The results obtained suggest that seasonality affects PA independently of the countries, pathologies of the participants and the tool to collect PA information. CONCLUSIONS: PA level varies across the seasons, with higher PA level in summer compared with other seasons, especially in winter. Sedentary behavior follows the opposite trend. Impact of seasonality variations should be considered in clinical research involving PA as a primary outcome as well as in interventions on PA promotion.

Effectiveness of Shock Wave Therapy as a Treatment for Spasticity: A Systematic Review.

BACKGROUND: The purpose of this study was to collect and analyse the available scientific evidence on the effectiveness of shock wave therapy as a treatment for spasticity. METHODS: the search was performed in the following databases: PubMed, PEDro, Cochrane, Embase, and the Virtual Health Library. All publications from November 2009 to November 2019 were selected that included a sample of patients with spasticity and prior suspension of botulinum toxin, to whom shock wave therapy was applied. The methodological quality of the articles was evaluated using the Jadad scale and the pyramid of quality of scientific evidence. RESULTS: 25 studies involving 866 participants with spasticity were selected. The results obtained suggest that shock wave therapy appears to be effective in reducing spasticity levels irrespective of the age of the participants, the type of injury, and the tool used to measure the effect. CONCLUSIONS: shock wave therapy reports evidence of improvement in motor function, motor impairment, pain, and functional independence, applied independently of botulinum toxin. However, due to the heterogeneity of the protocols, there is no optimum protocol for its application, and it would be appropriate to gain more high-quality scientific evidence through primary studies.

Strategies and Measurement Tools in Physical Activity Promotion Interventions in the University Setting: A Systematic Review.

The university environment is especially suitable for implementing health promotion interventions and specifically for physical activity promotion among university students. The objective of this systematic review was to describe the strategies employed and the physical activity data collection tools that have been used in said interventions. A systematic search for articles was conducted using the PubMED, Cochrane, and PEDro databases. The articles selected were those describing a physical activity promotion intervention aimed at university students in their own university setting in which there was a control group. Eventually, 1074 articles were identified, of which 13 fulfilled the selection criteria. The results show eight strategies and nine different instruments for collecting physical activity data. The strategies identified were used in combination and they were adapted in each of the complex interventions. Validated questionnaires were the most widely used instrument. Future original studies are needed to find out the impact of these strategies in physical activity promotion among university students specifically in the university context.

The impact of accessibility and service quality on the frequency of patient visits to the primary diabetes care provider: results from a cross-sectional survey performed in six European countries.

BACKGROUND: Visits to the primary diabetes care provider play a central role in diabetes care. Therefore, patients should attend their primary diabetes care providers whenever a visit is necessary. Parameters that might affect whether this condition is fulfilled include accessibility (in terms of travel distance and travel time to the practice), as well as aspects of service quality (for example in-practice waiting time and quality of the provider's communication with the patient). The relationships of these variables with the frequency of visits to the primary diabetes care provider are investigated. METHODS: The investigation is performed with questionnaire data of 1086 type 2 diabetes patients from study regions in England (213), Finland (135), Germany (218), Greece (153), the Netherlands (296) and Spain (71). Data were collected between October 2011 and March 2012. Data were analysed using log-linear Poisson regression models with self-reported numbers of visits in a year to the primary diabetes care provider as the criterion variable. Predictor variables of the core model were: country; gender; age; education; stage of diabetes; heart problems; previous stroke; problems with lower extremities; problems with sight; kidney problems; travel distance and travel time; in-practice waiting time; and quality of communication. To test region-specific characteristics, the interaction between the latter four predictor variables and study region was also investigated. RESULTS: When study regions are merged, travel distance and in-practice waiting time have a negative effect, travel time no effect and quality of communication a positive effect on visit frequency (with the latter effect being by far largest). When region specific effects are considered, there are strong interaction effects shown for travel distance, in-practice waiting time and quality of communication. For travel distance, as well as for in-practice waiting time, there are region-specific effects in opposite directions. For quality of communication, there are only differences in the strength with which visit frequency increases with this variable. CONCLUSIONS: The impact of quality of communication on visit frequency is the largest and is stable across all study regions. Hence, increasing quality of communication seems to be the best approach for increasing visit frequency.

Adaptation of TECCU App Based on Patients´ Perceptions for the Telemonitoring of Inflammatory Bowel Disease: A Qualitative Study Using Focus Groups.

Background: Despite the continuous adaptation of eHealth systems for patients with inflammatory bowel disease (IBD), a significant disconnection persists between users and developers. Since non-adherence remains high, it is necessary to better understand the patients' perspective on telemonitoring for IBD. Accordingly, this study aimed to adapt the TECCU telemonitoring app to the preferences and needs of IBD patients. Methods: A qualitative study was carried out using successive focus groups of IBD patients. Meetings were audio-recorded and a thematic analysis was employed until data saturation was achieved. The first group included patients who had used the TECCU App in a pilot clinical trial, and subsequent meetings included patients with Crohn's disease and ulcerative colitis recruited from the Spanish Confederation of patient associations. The information collected at each meeting guided consecutive changes to the platform. Results: Data saturation was reached after three focus groups involving a total of 18 patients. Three main themes emerged: (1) platform usability, (2) the communication process, and (3) platform content. All participants indicated that TECCU is easy to use, permitting continuous and personalized feedback. According to patients´ perspectives, the platform was adapted to foster a flexible follow-up and shared decision-making using open and safe communication networks. Many participants appreciated the educational elements and, consequently, the app was connected to reliable and continuously updated webpages. Conclusions: IBD patients valued the usability and personalized monitoring offered by the TECCU App. Improvements in the messaging system and continuously updated educational content were introduced to address patients´ needs and favor their engagement.

Robust association between vascular habitats and patient prognosis in glioblastoma: An international multicenter study.

BACKGROUND: Glioblastoma (GBM) is the most aggressive primary brain tumor, characterized by a heterogeneous and abnormal vascularity. Subtypes of vascular habitats within the tumor and edema can be distinguished: high angiogenic tumor (HAT), low angiogenic tumor (LAT), infiltrated peripheral edema (IPE), and vasogenic peripheral edema (VPE). PURPOSE: To validate the association between hemodynamic markers from vascular habitats and overall survival (OS) in glioblastoma patients, considering the intercenter variability of acquisition protocols. STUDY TYPE: Multicenter retrospective study. POPULATION: In all, 184 glioblastoma patients from seven European centers participating in the NCT03439332 clinical study. FIELD STRENGTH/SEQUENCE: 1.5T (for 54 patients) or 3.0T (for 130 patients). Pregadolinium and postgadolinium-based contrast agent-enhanced T1 -weighted MRI, T2 - and FLAIR T2 -weighted, and dynamic susceptibility contrast (DSC) T2 * perfusion. ASSESSMENT: We analyzed preoperative MRIs to establish the association between the maximum relative cerebral blood volume (rCBVmax ) at each habitat with OS. Moreover, the stratification capabilities of the markers to divide patients into "vascular" groups were tested. The variability in the markers between individual centers was also assessed. STATISTICAL TESTS: Uniparametric Cox regression; Kaplan-Meier test; Mann-Whitney test. RESULTS: The rCBVmax derived from the HAT, LAT, and IPE habitats were significantly associated with patient OS (P < 0.05; hazard ratio [HR]: 1.05, 1.11, 1.28, respectively). Moreover, these markers can stratify patients into "moderate-" and "high-vascular" groups (P < 0.05). The Mann-Whitney test did not find significant differences among most of the centers in markers (HAT: P = 0.02-0.685; LAT: P = 0.010-0.769; IPE: P = 0.093-0.939; VPE: P = 0.016-1.000). DATA CONCLUSION: The rCBVmax calculated in HAT, LAT, and IPE habitats have been validated as clinically relevant prognostic biomarkers for glioblastoma patients in the pretreatment stage. This study demonstrates the robustness of the hemodynamic tissue signature (HTS) habitats to assess the GBM vascular heterogeneity and their association with patient prognosis independently of intercenter variability. LEVEL OF EVIDENCE: 3 Technical Efficacy Stage: 2 J. Magn. Reson. Imaging 2020;51:1478-1486.

Correction: The relationship between context, structure, and processes with outcomes of 6 regional diabetes networks in Europe.

[This corrects the article DOI: 10.1371/journal.pone.0192599.].

Development of a universal short patient satisfaction questionnaire on the basis of SERVQUAL: Psychometric analyses with data of diabetes and stroke patients from six different European countries.

OBJECTIVE: A short questionnaire which can be applied for assessing patient satisfaction in different contexts and different countries is to be developed. METHODS: Six items addressing tangibles, reliability, responsiveness, assurance, empathy, and communication were analysed. The first five items stem from SERVQUAL (SERVice QUALity), the last stems from the discussion about SERVQUAL. The analyses were performed with data from 12 surveys conducted in six different countries (England, Finland, Germany, Greece, the Netherlands, Spain) covering two different conditions (type 2 diabetes, stroke). Sample sizes for included participants are 247 in England, 160 in Finland, 231 in Germany, 152 in Greece, 316 in the Netherlands and 96 in Spain for the diabetes surveys; and 101 in England, 139 in Finland, 107 in Germany, 58 in Greece, 185 in the Netherlands, and 92 in Spain for the stroke surveys. The items were tested by (1) bivariate correlations between the items and an item addressing 'general satisfaction', (2) multivariate regression analyses with 'general satisfaction' as criterion and the items as predictors, and (3) bivariate correlations between sum scores and 'general satisfaction'. RESULTS: The correlations with 'general satisfaction' are 0.48 for tangibles, 0.56 for reliability, 0.58 for responsiveness, 0.47 for assurance, 0.53 for empathy, and 0.56 for communication. In the multivariate regression analysis, the regression coefficient for assurance is significantly negative while all other regression coefficients are significantly positive. In a multivariate regression analysis without the item 'assurance' all regression coefficients are positive. The correlation between the sum score and 'general satisfaction' is 0.608 for all six items and 0.618 for the finally remaining five items. The country specific results are similar. CONCLUSIONS: The five items which remain after removing 'assurance', i.e. the SERVQUAL-MOD-5, constitute a short patient satisfaction index which can usefully be applied for different medical conditions and in different countries.

Telemonitoring of Crohn's Disease and Ulcerative Colitis (TECCU): Cost-Effectiveness Analysis.

BACKGROUND: Although electronic health interventions are considered safe and efficient, evidence regarding the cost-effectiveness of telemonitoring in inflammatory bowel disease is lacking. OBJECTIVE: We aimed to evaluate the cost-effectiveness and cost-utility of the Telemonitorización de la Enfermedad de Crohn y Colitis Ulcerosa (Telemonitoring of Crohn's Disease and Ulcerative Colitis [TECCU]) Web platform (G_TECCU intervention group) for telemonitoring complex inflammatory bowel disease, compared with standard care (G_control) and nurse-assisted telephone care (G_NT intervention group). METHODS: We analyzed cost-effectiveness from a societal perspective by comparing the 3 follow-up methods used in a previous 24-week randomized controlled trial, conducted at a tertiary university hospital in Spain. Patients with inflammatory bowel disease who initiated immunosuppressants or biologic agents, or both, to control inflammatory activity were recruited consecutively. Data on the effects on disease activity (using clinical indexes) and quality-adjusted life-years (using the EuroQol 5 dimensions questionnaire) were collected. We calculated the costs of health care, equipment, and patients' productivity and social activity impairment. We compared the mean costs per patient, utilities, and bootstrapped differences. RESULTS: We included 63 patients (21 patients per group). TECCU saved €1005 (US $1100) per additional patient in remission compared with G_control (95% CI €-13,518 to 3137; US $-14,798 to 3434), with a 79.96% probability of being more effective at lower costs. Compared with G_NT, TECCU saved €2250 (US $2463) per additional patient in remission (95% CI €-15,363 to 11,086; US $-16,817 to 12,135), and G_NT saved €538 (US $589) compared with G_control (95% CI €-6475 to 5303; US $-7088 to 5805). G_TECCU and G_NT showed an 84% and 67% probability, respectively, of producing a cost saving per additional quality-adjusted life-year (QALY) compared with G_control, considering those simulations that involved negative incremental QALYs as well. CONCLUSIONS: There is a high probability that the TECCU Web platform is more cost-effective than standard and telephone care in the short term. Further research considering larger cohorts and longer time horizons is required. TRIAL REGISTRATION: ClinicalTrials.gov NCT02943538; https://clinicaltrials.gov/ct2/show/NCT02943538 (http://www. webcitation.org/746CRRtDN).

A Web-Based Telemanagement System for Patients With Complex Inflammatory Bowel Disease: Protocol for a Randomized Controlled Clinical Trial.

BACKGROUND: Telemedicine has been successfully used to provide inflammatory bowel disease (IBD) patients with health care services remotely via the implementation of information and communications technology, which uses safe and feasible apps that have been well accepted by patients in remission. However, the design of telemedicine apps in this setting involves difficulties that hinder the adherence of patients to the follow-up plans and the efficacy of these systems to improve disease activity and quality of life. OBJECTIVE: This study aimed to evaluate the development of a Web platform, Telemonitoring of Crohn Disease and Ulcerative Colitis (TECCU), for remote monitoring of patients with complex IBD and the design of a clinical trial involving IBD patients who received standard care (G_Control), nurse-assisted telephone care (G_NT), or care based on distance monitoring (G_TECCU). METHODS: We describe the development of a remote monitoring system and the difficulties encountered in designing the platform. A 3-arm randomized controlled trial was designed to evaluate the effectiveness of this Web platform in disease management compared with G_NT and G_Control. RESULTS: According to the schedules established for the medical treatment initiated (corticosteroids, immunosuppressants, or biological agents), a total of 63 patients (21 patients from each group) answered periodic questionnaires regarding disease activity, quality of life, therapeutic adherence, adverse effects, satisfaction, work productivity, and social activities. Blood and stool analyses (fecal calprotectin) were performed periodically. On the basis of the results of these tests in G_TECCU, alerts were generated in a Web platform with adapted action plans, including changes in medication and frequency of follow-up. The main issues found were the development of an easy-to-use Web platform, the selection of validated clinical scores and objective biomarkers for remote monitoring, and the design of a clinical trial to compare the 3 main follow-up methods evaluated to date in IBD. CONCLUSIONS: The development of a Web-based remote management program for safe and adequate control of IBD proved challenging. The results of this clinical trial will advance knowledge regarding the effectiveness of TECCU Web platform for improvement of disease activity, quality of life, and use of health care resources in complex IBD patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT02943538; https://clinicaltrials.gov/ct2/show/NCT02943538 (Archived by WebCite at http://www.webcitation.org/6y4DQdmt8). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/9639.

A Web-Based Telemanagement System for Improving Disease Activity and Quality of Life in Patients With Complex Inflammatory Bowel Disease: Pilot Randomized Controlled Trial.

BACKGROUND: The reported efficacy of telemedicine in patients with inflammatory bowel disease (IBD) is inconsistent among studies, and data for complex IBD are lacking. OBJECTIVE: We aimed to evaluate the impact of remote monitoring using a Web system-Telemonitorización de la Enfermedad de Crohn y Colitis Ulcerosa or Telemonitoring of Crohn's Disease and Ulcerative Colitis (TECCU)-as compared to standard care and telephone care on health outcomes and health care in patients with complex IBD. METHODS: We performed a 3-arm randomized controlled trial. Adult patients with IBD who received immunosuppressants and biological agents were recruited from the IBD Unit of a tertiary university hospital. The patients were randomized into groups to receive remote monitoring (G_TECCU), nurse-assisted telephone care (G_NT), or standard care with in-person visits (G_control). All patients completed the study visits at baseline and at 12 and 24 weeks in addition to each type of intervention. The primary outcome was the percentage of patients in remission at 24 weeks. Secondary health outcomes were quality of life, medication adherence, adverse effects, satisfaction, and social activities. Data on the number of outpatient visits and telephone calls, emergency visits, hospitalizations, IBD-related surgeries, and corticosteroid courses were also collected. RESULTS: A total of 63 patients were selected (21 patients in each group). During the study, 90.5% (19/21) of patients in G_control, 95.2% (20/21) in G_NT, and 85.7% (18/21) in G_TECCU were compliant to the intervention. After 24 weeks, the percentage of patients in remission was higher in G_TECCU (17/21, 81%) than in G_NT (14/21, 66.7%) and G_control (15/21, 71.4%). A higher improvement in disease activity was observed in G_TECCU than in G_control in terms of the Harvey-Bradshaw/Mayo (odds ratio=0.12, 95% CI=0.003-2.162, P=.19) and Harvey-Bradshaw/Walmsley (odds ratio=0.11, 95% CI=0.004-1.55, P=.13) indexes. Improvement in disease activity was associated with a larger reduction in fecal calprotectin values in G_TECCU compared to G_control (estimated intervention effect: odds ratio=-0.90; 95% CI=-1.96 to 0.16, P=.11). All completers adhered to treatment in G_TECCU. In addition, the quality of life, social activities, and satisfaction improved in all 3 groups. Although the number of outpatient visits and telephone calls was lower in G_TECCU than in G_NT and G_control, the safety profile was similar in all 3 groups. CONCLUSIONS: This pilot clinical trial suggests that the TECCU Web-based system is a safe strategy for improving health outcomes in patients with complex IBD and reducing the use of health care resources. TRIAL REGISTRATION: ClinicalTrials.gov NCT02943538; https://clinicaltrials.gov/ct2/show/NCT02943538 (Archived by WebCite at http://www.webcitation.org/746CRRtDN).

The effect of telehealth, telephone support or usual care on quality of life, mortality and healthcare utilization in elderly high-risk patients with multiple chronic conditions. A prospective study.

BACKGROUND AND OBJECTIVE: To assess the effect of home based telehealth or structured telephone support interventions with respect to usual care on quality of life, mortality and healthcare utilization in elderly high-risk multiple chronic condition patients. PATIENTS AND METHODS: 472 elderly high-risk patients with plurimorbidity in the region of Valencia (Spain) were recruited between June 2012 and May 2013, and followed for 12 months from recruitment. Patients were allocated to either: (a) a structured telephone intervention, a nurse-led case management program with telephone follow up every 15 days; (b) telehealth, which adds technology for remote self-management and the exchange of clinical data; or (c) usual care. Main outcome measures was quality of life measured by the EuroQol (EQ-5D) instrument, cognitive impairment, functional status, mortality and healthcare resource use. Inadequate randomization process led us to used propensity scores for adjusted analyses to control for imbalances between groups at baseline. RESULTS: EQ-5D score was significantly higher in the telehealth group compared to usual care (diff: 0.19, 0.08-0.30), but was not different to telephone support (diff: 0.04, -0.05 to 0.14). In adjusted analyses, inclusion in the telehealth group was associated with an additional 0.18 points in the EQ-5D score compared to usual care at 12 months (p<0.001), and with a gain of 0.13 points for the telephone support group (p<0.001). No differences in mortality or utilization were found, except for a borderline significant increase in General Practitioner visits. CONCLUSIONS: Telehealth was associated with better quality of life. Important limitations of the study and similarity of effects to telephone intervention call for careful endorsement of telemedicine. Clinicaltrials.gov (identifier: NCT02447562).

The relationship between context, structure, and processes with outcomes of 6 regional diabetes networks in Europe.

BACKGROUND: While health service provisioning for the chronic condition Type 2 Diabetes (T2D) often involves a network of organisations and professionals, most evidence on the relationships between the structures and processes of service provisioning and the outcomes considers single organisations or solo practitioners. Extending Donabedian's Structure-Process-Outcome (SPO) model, we investigate how differences in quality of life, effective coverage of diabetes, and service satisfaction are associated with differences in the structures, processes, and context of T2D services in six regions in Finland, Germany, Greece, Netherlands, Spain, and UK. METHODS: Data collection consisted of: a) systematic modelling of provider network's structures and processes, and b) a cross-sectional survey of patient reported outcomes and other information. The survey resulted in data from 1459 T2D patients, during 2011-2012. Stepwise linear regression models were used to identify how independent cumulative proportion of variance in quality of life and service satisfaction are related to differences in context, structure and process. The selected context, structure and process variables are based on Donabedian's SPO model, a service quality research instrument (SERVQUAL), and previous organization and professional level evidence. Additional analysis deepens the possible bidirectional relation between outcomes and processes. RESULTS: The regression models explain 44% of variance in service satisfaction, mostly by structure and process variables (such as human resource use and the SERVQUAL dimensions). The models explained 23% of variance in quality of life between the networks, much of which is related to contextual variables. Our results suggest that effectiveness of A1c control is negatively correlated with process variables such as total hours of care provided per year and cost of services per year. CONCLUSIONS: While the selected structure and process variables explain much of the variance in service satisfaction, this is less the case for quality of life. Moreover, it appears that the effect of the clinical outcome A1c control on processes is stronger than the other way around, as poorer control seems to relate to more service use, and higher cost. The standardized operational models used in this research prove to form a basis for expanding the network level evidence base for effective T2D service provisioning.

Telemedicine in the treatment of patients with inflammatory bowel disease. / Telemedicina en el manejo de pacientes con enfermedad inflamatoria intestinal.

Inflammatory bowel disease (IBD) is a chronic and relapsing disorder with significant medical, social and financial impacts. IBD patients require continuous follow-up, and healthcare resource use in this context increases over time. In the last decade, telemedicine has influenced the treatment of chronic diseases like IBD via the application of information and communication technologies to provide healthcare services remotely. Telemedicine and its various applications (telemanagement, teleconsulting and tele-education) enable closer follow-up and provide education resources that promote patient empowerment, encouraging treatment optimisation over the entire course of the disease. We describe the impact of using telemedicine on IBD health outcomes and discuss the limitations of implementing these systems in the real-life management of IBD patients.

The impact of travel distance, travel time and waiting time on health-related quality of life of diabetes patients: An investigation in six European countries.

AIMS: The effects of travel distance and travel time to the primary diabetes care provider and waiting time in the practice on health-related quality of life (HRQoL) of patients with type 2 diabetes are investigated. RESEARCH DESIGN AND METHODS: Survey data of 1313 persons with type 2 diabetes from six regions in England (274), Finland (163), Germany (254), Greece (165), the Netherlands (354), and Spain (103) were analyzed. Various multiple linear regression analyses with four different EQ-5D-3L indices (English, German, Dutch and Spanish index) as target variables, with travel distance, travel time, and waiting time in the practice as focal predictors and with control for study region, patient's gender, patient's age, patient's education, time since diagnosis, thoroughness of provider-patient communication were computed. Interactions of regions with the remaining five control variables and the three focal predictors were also tested. RESULTS: There are no interactions of regions with control variables or focal predictors. The indices decrease with increasing travel time to the provider and increasing waiting time in the provider's practice. CONCLUSIONS: HRQoL of patients with type 2 diabetes might be improved by decreasing travel time to the provider and waiting time in the provider's practice.