Cost-effectiveness of multicomponent interventions in type 2 diabetes mellitus in a cluster randomised controlled trial: the INDICA study

Objective: To analyse the cost-effectiveness of multicomponent interventions designed to improve outcomes in type 2 diabetes mellitus (T2DM) in primary care in the Canary Islands, Spain, within the INDICA randomised clinical trial, from the public health system perspective. Design: An economic evaluation was conducted for the within-trial period (2 years) comparing the four arms of the INDICA study. Setting: Primary care in the Canary Islands, Spain. Participants: 2334 patients with T2DM without complications were included. Interventions: Interventions for patients (PTI), for primary care professionals (PFI), for both (combined intervention arm for patients and professionals, CBI) and usual care (UC) as a control group. Outcomes: The main outcome was the incremental cost per quality-adjusted life-years (QALY). Only the intervention and the healthcare costs were included. Analysis: Multilevel models were used to estimate results, and to measure the size and significance of incremental changes. Missed values were treated by means of multiple imputations procedure. Results: There were no differences between arms in terms of costs (p=0.093), while some differences were observed in terms of QALYs after 2 years of follow-up (p=0.028). PFI and CBI arms were dominated by the other two arms, PTI and UC. The differences between the PTI and the UC arms were very small in terms of QALYs, but significant in terms of healthcare costs (p=0.045). The total cost of the PTI arm (€2571, 95% CI €2317 to €2826) was lower than the cost in the UC arm (€2750, 95% CI €2506 to €2995), but this difference did not reach statistical significance. Base case estimates of the incremental cost per QALY indicate that the PTI strategy was the cost-effective option. Conclusions: The INDICA intervention designed for patients with T2DM and families is likely to be cost-effective from the public healthcare perspective. A cost-effectiveness model should explore this in the long term.This study received financial support from the Spanish Ministry of Economy, Industry and Competitiveness (Instituto de Salud Carlos III), grants: ADE10/00032 and PI16/00769, jointly funded by the European Regional Development Fund (FEDER) ‘A way to make Europe’. The sponsor did not play any role in study design, collection, analysis and interpretation of data, drawing up of the report or the decision to submit the article for publication.S

The relationship between patient empowerment and related constructs, affective symptoms and quality of life in patients with type 2 diabetes: a systematic review and meta-analysis

IntroductionThe aim of this systematic review is to assess the relationship between patient empowerment and other empowerment-related constructs, and affective symptoms and quality of life in patients with type 2 diabetes.MethodsA systematic review of the literature was conducted, according to the PRISMA guidelines. Studies addressing adult patients with type 2 diabetes and reporting the association between empowerment-related constructs and subjective measures of anxiety, depression and distress, as well as self-reported quality of life were included. The following electronic databases were consulted from inception to July 2022: Medline, Embase, PsycINFO, and Cochrane Library. The methodological quality of the included studies was analyzed using validated tools adapted to each study design. Meta-analyses of correlations were performed using an inverse variance restricted maximum likelihood random-effects.ResultsThe initial search yielded 2463 references and seventy-one studies were finally included. We found a weak-to-moderate inverse association between patient empowerment-related constructs and both anxiety (r = −0.22) and depression (r = −0.29). Moreover, empowerment-related constructs were moderately negatively correlated with distress (r = −0.31) and moderately positively correlated with general quality of life (r = 0.32). Small associations between empowerment-related constructs and both mental (r = 0.23) and physical quality of life (r = 0.13) were also reported.DiscussionThis evidence is mostly from cross-sectional studies. High-quality prospective studies are needed not only to better understand the role of patient empowerment but to assess causal associations. The results of the study highlight the importance of patient empowerment and other empowerment-related constructs such as self-efficacy or perceived control in diabetes care. Thus, they should be considered in the design, development and implementation of effective interventions and policies aimed at improving psychosocial outcomes in patients with type 2 diabetes.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020192429, identifier CRD42020192429

Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making

The Monitoring Studies (MS) program, the approach developed by RedETS to generate postlaunch real-world evidence (RWE), is intended to complement and enhance the conventional health technology assessment process to support health policy decision making in Spain, besides informing other interested stakeholders, including clinicians and patients. The MS program is focused on specific uncertainties about the real effect, safety, costs, and routine use of new and insufficiently assessed relevant medical devices carefully selected to ensure the value of the additional research needed, by means of structured, controlled, participative, and transparent procedures. However, despite a clear political commitment and economic support from national and regional health authorities, several difficulties were identified along the development and implementation of the first wave of MS, delaying its execution and final reporting. Resolution of these difficulties at the regional and national levels and a greater collaborative impulse in the European Union, given the availability of an appropriate methodological framework already provided by EUnetHTA, might provide a faster and more efficient comparative RWE of improved quality and reliability at the national and international levels

Exploring value creation in a virtual community of practice: a framework analysis for knowledge and skills development among primary care professionals

Abstract Background Healthcare professionals traditional education reflects constraints to face the complex needs of people with chronic diseases in primary care settings. Since more innovative and practical solutions are required, Virtual Community of Practices (vCoP) seem to better respond to learning updates, improving professional and organizational knowledge. However, little is known about the value created in vCoPs as social learning environments. The objective of this project was to explore the value creation process of a gamified vCoP (“e-mpodera vCoP”) aimed at improving the knowledge and attitudes of primary healthcare professionals (PCPs) (nurses and general practitioners) to the empowerment of people with chronic conditions. Methods A framework analysis assessed the value creation process using a mixed methods approach. The framework provided awareness about knowledge and usefulness in a learning community through five cycles: (1) immediate value, (2) potential value, (3) applied value, (4) realized value, and (5) reframing value. Quantitative data included vCoP analytics such as logins, contributions, points, badges, and performance metrics. Qualitative data consisted of PCPs’ forum contributions from Madrid, Catalonia, and Canary Islands over 14 months. Results A total of 185 PCPs had access to the e-mpodera vCoPs. The vCoP showed the dynamic participation of 146 PCPs, along 63 content activities posted, including a total of 3,571 contributions (including text, images, links to webpages, and other files). Regarding the value creation process, the e-mpodera vCoP seems to encompass a broad spectrum of value cycles, with indicators mostly related to cycle 1 (immediate value – activities and interactions) and cycle 2 (potential value – knowledge capital); and to a lesser extent for cycle 3 (applied value – changes in practice) and for cycle 4 (realized value – performance improvement). The presence of indicators related to cycle 5 (reframing value), was minimal, due to few individual redefinitions of success. Conclusion To reach a wider range of value possibilities, a combination of learning objectives, competence framework, challenged-based gamified platform, and pathway model of skill development seems crucial. However, additional research is required to gain clearer insights into organizational values, professionals’ lifelong educational needs in healthcare, and the long-term sustainability of performance improvement. Trial registration ClinicalTrials.gov, NCT02757781. Registered on 02/05/2016

Preliminary assessment of the degree of food addiction through the Spanish Yale Food Addiction Scale for Children (S-YFAS-C) in a pilot pediatric population

Abstract Introduction The Spanish Yale Food Addiction Scale for Children (S-YFAS-C) scale is the first tool adapted to Spanish to evaluate food addiction (FA) in the paediatric population. The aim of this study is to preliminarily evaluate the degree of FA in a non-clinical pilot paediatric population. Material and methods A transversal observational study was performed on a convenience sample comprised of boys and girls aged 9 to 12 (4th to 6th year primary school). The main outcome measures were evaluation of FA (S-YFAS-C scale), child feeding attitudes (ChEAT scale) and evaluation of body image (CDRS scale). Moreover, sociodemographic and anthropometric data were collected. A descriptive and bivariate analysis of the main characteristics of subjects and outcome measures was performed. Results A total of 21 boys and 24 girls were preliminarily evaluated and the minimum and maximum values obtained were for age (9.48–12.33), weight in kilograms (26.6–64.5), height in centimetres (131–163), BMI (14.2–27.9) and BMI Z-score (−1.36–2.66). The average number of FA symptoms measured with the S-YFAS-C scale is 1.67 ± 1.45 (range 0–7). A total of 20% of the sample shows three or more symptoms for FA, risk of developing a food disorder and distortion of the body image. Moreover, statistically significant differences were observed between desired body image in boys and girls (P = 0.001). Conclusions The S-YFAS-C scale enables evaluating food addiction in Spanish-speaking boys and girls. The data obtained in regard to quantifying symptoms are similar compared to the original scale (S-YFAS-C: 1.67 ± 1.45 vs. YFAS-C: 2 ± 1.81). The option to score the counting of symptoms is the most sensitive measure to evaluate subclinical food behaviours

Additional file 1 of Exploring value creation in a virtual community of practice: a framework analysis for knowledge and skills development among primary care professionals

Supplementary Material

Effectiveness of Internet-Based Multicomponent Interventions for Patients and Health Care Professionals to Improve Clinical Outcomes in Type 2 Diabetes Evaluated Through the INDICA Study: Multiarm Cluster Randomized Controlled Trial.

Type 2 diabetes mellitus (T2DM) is a chronic disease in which health outcomes are related to decision making by patients and health care professionals. This study aims to assess the effectiveness of internet-based multicomponent interventions to support decision making of all actors involved in the care of patients with T2DM in primary care. The INDICA study is an open, community-based, multicenter trial with random allocation to usual care or the intervention for patients, the intervention for health care professionals in primary care, or the combined intervention for both. In the intervention for patients, participants received an educational group program and were monitored and supported by logs, a web-based platform, and automated SMS. Those in the intervention for professionals also received an educational program, a decision support tool embedded in the electronic clinical record, and periodic feedback about patients' results. A total of 2334 people with T2DM, regardless of glycated hemoglobin (HbA1c) levels and without diabetes-related complications, were included. The primary end point was change in HbA1c level. The main analysis was performed using multilevel mixed models. For the overall sample, the intervention for patients attained a significant mean reduction in HbA1c levels of ‒0.27 (95% CI ‒0.45 to ‒0.10) at month 3 and ‒0.26 (95% CI ‒0.44 to ‒0.08) at month 6 compared with usual care, which remained marginally significant at month 12. A clinically relevant reduction in HbA1c level was observed in 35.6% (191/537) of patients in the intervention for patients and 26.0% (152/586) of those in usual care at month 12 (P=.006). In the combined intervention, HbA1c reduction was significant until month 18 (181/557, 32.6% vs 140/586, 23.9%; P=.009). Considering the subgroup of patients uncontrolled at baseline, all interventions produced significant reductions in HbA1c levels across the entire study period: ‒0.49 (95% CI ‒0.70 to ‒0.27) for the intervention for patients, ‒0.35 (95% CI ‒0.59 to ‒0.14) for the intervention for professionals, and ‒0.35 (95% CI ‒0.57 to ‒0.13) for the combined intervention. Differences in HbA1c for the area under the curve considering the entire period were significant for the intervention for patients and the combined intervention compared with usual care (P=.03 for both). Compared with usual care, the intervention for professionals and the combined intervention had significant longer-term reductions in systolic and diastolic blood pressure. In uncontrolled patients, the intervention for patients at baseline provided clinically relevant and significant longer-term reductions of HbA1c levels. The intervention for professionals and combined intervention also improved the cardiovascular risk profile of patients. ClinicalTrials.gov NCT01657227; https://clinicaltrials.gov/ct2/show/NCT01657227.This study received financial support from the Spanish Ministry of Economy, Industry, and Competitiveness (Instituto de Salud Carlos III), grant numbers ADE10/00032 and PI16/00769, cofounded by Fondo Europeo de Desarrollo Regional Una manera de hacer Europa. The funders did not participate in the study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication.S

Effectiveness of interventions to improve adherence to antidepressant medication in patients with depressive disorders: a cluster randomized controlled trial

Aim: To assess the effectiveness of two interventions of knowledge transfer and behavior modification to improve medication adherence in patients with depressive disorders. Methods: An open, multicenter, three-arm clinical trial with random allocation by cluster to usual care or to one of the two interventions. The intervention for psychiatrists (PsI) included an educational program based on a patient-centered care model. The intervention for patients and relatives (PtI) included a collaborative care program plus a reminder system that works using an already available medication reminder application. The primary outcome was patient adherence to antidepressant treatment assessed through the Sidorkiewicz Adherence Instrument. Secondary measures were depression severity, comorbid anxiety and health-related quality of life. Mixed regression models with repeated measures were used for data analysis. Results: Ten psychiatrists and 150 patients diagnosed with depressive disorder from eight Community Mental Health Units in the Canary Islands (Spain) were included. Compared with usual care, no differences in long-term adherence were observed in either group PsI or PtI. The PsI group had significantly improved depression symptoms (B = -0.39; 95%CI: -0.65, -0.12; p = 0.004) during the follow-up period. The PtI group presented improved depression symptoms (B = -0.63; 95%CI: -0.96, -0.30; p < 0.001) and mental quality of life (B = 0.08; 95%CI: 0.004, 0.15; p = 0.039) during the follow-up period. Conclusion: The assessed interventions to improve adherence in patients with depressive disorder were effective for depression symptoms and mental quality of life, even over the long term. However, no effect on antidepressant adherence was observed.Instituto de Salud Carlos III through the project “PI18/00767” (Co-funded by European Regional Development Fund/European Social Fund “A way to make Europe”/“Investing in your future”)5.2 Q1 JCR 20220.895 Q1 SJR 2023No data IDR 2023UE

Increased Patient Empowerment Is Associated with Improvement in Anxiety and Depression Symptoms in Type 2 Diabetes Mellitus: Findings from the INDICA Study

Introduction. In cross-sectional analyses, higher levels of patient empowerment have been related to lower symptoms of anxiety and depression. The aims of this study are: (1) to assess if patient empowerment predicts anxiety and depression symptoms after 12 and 24 months among patients with type 2 diabetes mellitus, and (2) to analyze whether a change in patient empowerment is associated with a change in anxiety and depression level. Methods. This is a secondary analysis of the INDICA study, a 24 month-long, multi-arm randomized controlled trial. Patient empowerment (DES-SF), depression (BDI-II), and state-anxiety (STAI-S) were assessed at the baseline (pre-intervention) and after 12 and 24 months. Multilevel mixed linear models with a random intercept were performed to correct for our clustered data. Results. The multilevel regression models showed that the baseline empowerment did not significantly predict anxiety and depression after 12 and 24 months. However, a higher increase in patient empowerment was significantly associated with reductions of anxiety (p &lt; 0.001) and depression levels (p &lt; 0.001). This association was not significantly different between the two follow-ups. Conclusion. This study contributes to the knowledge on how to reduce affective symptoms in patients with uncomplicated T2DM through comprehensive patient-centered interventions, and it highlights patient empowerment as a significant contributor