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Abstract Background Foley catheters have been subject to limited development in the last few decades. They fulfil their basic function of draining urine from the bladder but cause other associated problems. T‐Control is a new silicone Foley catheter with an integrated fluid control valve whose design aims to reduce the risks associated with bladder catheterisation by a multifactorial approach. The general purpose of this study is to evaluate the effectiveness and cost‐effectiveness of the T‐Control catheter versus the Foley‐type catheter in patients with Acute Urine Retention (AUR). Study design This is a pragmatic, open, multicentre, controlled clinical trial with random allocation to the T‐Control catheter or a conventional Foley‐type catheter in patients with AUR. Endpoints The magnitude of infections will be analysed as a primary endpoint. While as secondary endpoint, the following will be analysed: rate of symptomatic and asymptomatic infections; days free of infection; quality of life‐related to self‐perceived health; indication of associated antibiotic treatments; determination of biofilm; number of catheter‐related adverse events; use of each type of catheterisation's healthcare resources; level of satisfaction and workload of health professionals and acceptability of the T‐Control device as well as the patient experience. Patients and methods Eligible patients are male adults aged ≥50 years, with AUR and with an indication of bladder catheterisation for at least 2 weeks. The estimated sample size is 50 patients. Patient follow‐up includes both the time of catheter insertion and its removal or change 2 weeks later, plus 2 weeks after this time when the patient will be called for an in‐depth interview.

La unión de la teoría y la práctica es crucial para una enseñanza equitativa, además se requiere de estrategias flexibles y efectivas para asegurar la inclusión. El objetivo de este artículo fue proponer estrategias para la participación de estudiantes con discapacidad en las clases de Educación Física. Se revisaron 22 trabajos centrados en estrategias de inclusión para Educación Física en las bases de datos SciELO, Google Académico y Dialnet. A partir de los resultados obtenidos, se procedió a la sistematización y se diseñaron estrategias para mejorar la experiencia de aprendizaje y promover la igualdad, entre ellas las que se adaptan al currículo y actividades; las de formación y sensibilización docente; y, las de cultura inclusiva y ambiente positivo. Se concluye que la inclusión educativa es un proceso complejo que demanda cambios en actitudes, metodologías y políticas educativas.

Objectives This study aimed to evaluate the effectiveness, safety and costs of FreeStyle Libre (FSL) glucose monitoring system for children and adolescents with type 1 diabetes mellitus (T1DM) in Spain.Design Prospective, multicentre pre-post study.Setting Thirteen Spanish public hospitals recruited patients from January 2019 to March 2020, with a 12-month follow-up.Participants 156 patients were included.Primary and secondary outcome measures Primary: glycated haemoglobin (HbA1c) change. Secondary: severe hypoglycaemic events (self-reported and clinical records), quality of life, diabetes treatment knowledge, treatment satisfaction, adverse events, adherence, sensor usage time and scans. Healthcare resource utilisation was assessed for cost analysis from the National Health System perspective, incorporating direct healthcare costs. Data analysis used mixed regression models with repeated measures. The intervention’s total cost was estimated by multiplying health resource usage with unit costs.Results In the whole sample, HbA1c increased significantly (0.32%; 95% CI 0.10% to 0.55%). In the subgroup with baseline HbA1c≥7.5% (n=88), there was a significant reduction at 3 months (−0.46%; 95% CI −0.69% to −0.23%), 6 months (−0.49%; 95% CI −0.73% to −0.25%) and 12 months (−0.43%; 95% CI −0.68% to –0.19%). Well-controlled patients had a significant 12-month worsening (0.32%; 95% CI 0.18% to 0.47%). Self-reported severe hypoglycaemia significantly decreased compared with the previous year for the whole sample (−0.37; 95% CI −0.62 to –0.11). Quality of life and diabetes treatment knowledge showed no significant differences, but satisfaction increased. Adolescents had lower sensor usage time and scans than children. Reduction in HbA1c was significantly associated with device adherence. No serious adverse effects were observed. Data suggest that use of FSL could reduce healthcare resource use (strips and lancets) and costs related to productivity loss.Conclusions The use of FSL in young patients with T1DM was associated with a significant reduction in severe hypoglycaemia, and improved HbA1c levels were seen in patients with poor baseline control. Findings suggest cost savings and productivity gains for caregivers. Causal evidence is limited due to the study design. Further research is needed to confirm results and assess risks, especially for patients with lower baseline HbA1c.

Abstract Introduction Scalp cooling (SC) aims to prevent chemotherapy‐induced alopecia. The goal of this systematic review is to tackle ethical, legal, organizational and social issues related to SC. Methods A critical appraisal of the literature was carried out using a systematic review design. MEDLINE, Embase and Web of Science databases were searched up until 2 June 2021. Studies addressing these aspects in English or Spanish were considered. Representatives of both patient associations and professional scientific societies related to the topic participated in the design of the protocol and the review of the findings. Results A total of 17 studies were included. Articles were critically appraised using the MMAT and SANRA. Findings were organized into four categories: (1) ethical aspects focused on equal access, gender equity and doctor–patient communication supported by Patient Decision Aids (PtDAs); (2) patient perspective and acceptability; (3) professional perspective and acceptability; (4) organizational aspects focused on accessibility and feasibility. Conclusion Cancer patients' expectations when using SC need to be adjusted to reduce the potential distress associated with hair loss. PtDAs could help patients clarify their values and preferences regarding SC. Equal access to technology should be guaranteed. Patient or Public Contribution In this systematic review, the representatives of the patient associations (Ms. María Luz Amador Muñoz of the Spanish Association Against Cancer [AECC] and Ms. Catiana Martinez Cánovas of the Spanish Breast Cancer Federation [FECMA]) participated in the review of the study protocol, as well as in the results, discussion and conclusions, making their contributions. In the type of design of these studies (systematic reviews), it is not usual to have the direct participation of patients, but in this one, we have done so, as it is a systematic review that is part of a report of the Spanish Network of Health Technology Assessment Agencies (ETS).

Abstract Objective The aim of the present study is to identify factors associated with patient empowerment in people living with type 2 diabetes mellitus (T2DM) in the Canary Islands (Spain). Methods Secondary cross‐sectional analysis was carried out of data obtained in the INDICA study: A 24‐month cluster randomized‐controlled trial evaluating the effectiveness of educational interventions supported by new technology decision tools for T2DM patients. Sociodemographic variables, clinical data (years since diagnosis, glycated haemoglobin level, creatine, triglycerides, waist hip index, body mass index and number of comorbidities), diabetes knowledge (DIATEK), affective outcomes (Beck Depression Inventory‐II, the State subscale of the State‐Trait Anxiety Inventory and The Diabetes Distress Scale) and diabetes‐related quality of life (The Audit of Diabetes‐Dependent Quality of life) were assessed as potential correlates of patient empowerment, assessed using the Diabetes Empowerment Scale‐Short Form. Multilevel mixed linear regression models on patient empowerment were developed. Results The analysis included the baseline data of 2334 patients. Results showed that age (B = −0.14; p

Context: Prostate cancer (PCa) is the second most common type of cancer in men. Individualized risk stratification is crucial to adjust decision-making. A variety of molecular biomarkers have been developed in order to identify patients at risk of clinically significant PCa (csPCa) defined by the most common PCa risk stratification systems. Objective: The present study aims to examine the effectiveness (diagnostic accuracy) of blood or urine-based PCa biomarkers to identify patients at high risk of csPCa. Evidence acquisition: A systematic review of the literature was conducted. Medline and EMBASE were searched from inception to March 2021. Randomized or nonrandomized clinical trials, and cohort and case-control studies were eligible for inclusion. Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool. Pooled estimates of sensitivity, specificity, and area under the curve were obtained. Evidence synthesis: Sixty-five studies (N = 34 287) were included. Not all studies included prostate-specific antigen-selected patients. The pooled data showed that the Prostate Health Index (PHI), with any cutoff point between 15 and 30, had sensitivity of 0.95–1.00 and specificity of 0.14–0.33 for csPCa detection. The pooled estimates for SelectMDx test sensitivity and specificity were 0.84 and 0.49, respectively. Conclusions: The PHI test has a high diagnostic accuracy rate for csPCa detection, and its incorporation in the diagnostic process could reduce unnecessary biopsies. However, there is a lack of evidence on patient-important outcomes and thus more research is needed. Patient summary: It has been possible to verify that the application of biomarkers could help detect prostate cancer (PCa) patients with a higher risk of poorer evolution. The Prostate Health Index shows an ability to identify 95–100 for every 100 patients suffering from clinically significant PCa who take the test, preventing unnecessary biopsies in 14–33% of men without PCa or insignificant PCa.

BackgroundPatients with refractory symptoms of severe diseases frequently experience anxiety, depression, and an altered health-related quality of life (HRQOL). Some publications have described the beneficial effect of ozone therapy on several symptoms of this kind of patient. The aim of this study was to preliminarily evaluate, in patients treated because of refractory symptoms of cancer treatment and advanced nononcologic diseases, if ozone therapy has an additional impact on self-reported anxiety and depression.MethodsBefore and after ozone treatment, we assessed (i) anxiety and depression according to the Hospital Anxiety and Depression Scale (HADS); (ii) the HRQOL (according to the EQ-5D-5L questionnaire), which includes a dimension on anxiety and depression and a visual analog scale (VAS) measuring self-perceived general health.ResultsBefore ozone therapy, 56% of patients were on anxiolytic and/or antidepressant treatment. Before and after ozone therapy, the anxiety and depression HADS subscales (i) significantly correlated with the anxiety/depression dimension of the EQ-5D-5L questionnaire and (ii) inversely correlated with the health status as measured by the VAS. After ozone therapy, we found a significant improvement in anxiety and depression measured by both the (i) HADS subscales and (ii) EQ-5D-5L questionnaire.ConclusionThe addition of ozone therapy for patients with refractory symptoms of cancer treatment and advanced chronic nononcologic diseases can decrease anxiety and depression severity levels. Additional, more focused studies are ongoing to provide the needed explanatory information for this finding.

Abstract Background Generalized anxiety disorder (GAD) is one of the most prevalent mental health problems. Patients with GAD have unmet needs related to the information received about their disorder, its treatments and their participation in the decision-making process. The aim of this study is to develop and assess the acceptability of a patient decision aid (PtDA) for patients with GAD. Method The PtDA was developed following the International Patient Decision Aid Standards. The recommendations of the Spanish clinical practice guideline (CPG) for patients with GAD were used as the basis. The first prototype was developed by an expert committee, further improvements were made with patients (n = 2), clinical experts (n = 13) and the project management group (n = 7). The acceptability of this second draft was assessed by patients non-involved in the previous phases (n = 11). Results The final PtDA version included a brief description of GAD and its treatments. Most participants agreed that the PtDA was easy to use, visually appealing and useful. At least half of the participants learned new things about treatments and adverse effects. Conclusions A PtDA was developed for patients with GAD based on recommendations from the Spanish CPG. It was improved and accepted by patients and clinical experts involved. An evaluation of its effectiveness on the shared decision-making process during the clinical encounter is planned.

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.

Background: Pain secondary to chemotherapy-induced peripheral neuropathy (CIPN) can limit the administration of chemotherapy, cancer-treatment outcomes, and the quality of life of patients. Oxidative stress and inflammation are some of the key mechanisms involved in CIPN. Successful treatments for CIPN are limited. This report shows our preliminary experience using ozone treatment as a modulator of oxidative stress in chronic pain secondary to CIPN.Methods: Ozone treatment, by rectal insufflation, was administered in seven patients suffering from pain secondary to grade II or III CIPN. Pain was assessed by the visual analog scale (VAS).Results: All patients, except one, showed clinically relevant pain improvement. Median pain score according to the VAS was 7 (range: 5–8) before ozone treatment, 4 (range: 2–6) at the end of ozone treatment (p = 0.004), 5.5 (range: 1.8–6.3) 3 months after the end of ozone treatment (p = 0.008), and 6 (range: 2.6–6.6) 6 months after the end of ozone treatment (p = 0.008). The toxicity grade, according to the Common Terminology Criteria for Adverse Events (CTCAE v.5.0), improved in half of the patients.Conclusion: This report shows that most patients obtained clinically relevant and long-lasting improvement in chronic pain secondary to CIPN after treatment with ozone. These observed effects merit further research and support our ongoing randomized clinical trial (NCT04299893).

Shared decision making (SDM) aims to involve patients in the decisions about their care, considering their preferences, values and concerns about the different treatment options. However, research shows that people with mental health problems have considerable unmet information needs about their condition. This community-based cross-sectional study explores the SDM process and information needs among people with Generalized Anxiety Disorder (GAD), as an initial step in the design and development of a Patient Decision Aid for this population. Seventy participants completed an online survey with the Control Preference Scale, and questions about the perceived difficulty of past treatment decisions and the use of the Internet for searching for GAD-related information. Most participants preferred an active (42.9%) or collaborative role (41.4%) in the SDM process, and 53% did not perceive their preferred role. Information provided by healthcare professionals was considered insufficient by 28% of the sample, and over 30% reported using the Internet to look for GAD-related information at least once a week or more. The most relevant GAD-related information needs were general information (71.4%), information on self-help groups (65.7%), recommendations on how to face this disorder (61.4%) and information on treatment options (50%). Exploratory analyses showed that patients who perceived an active participation were more likely to search for information frequently (p = 0.038), and those who felt more involved than desired tended to search for more themes (p = 0.049). In summary, the study showed that a considerable percentage of GAD patients have unmet needs related to decision-making participation and information.

Abstract Objective The aim of this scoping review was to overview the cost-of-illness studies conducted in rare diseases. Methods We searched papers published in English in PubMed from January 2007 to December 2018. We selected cost-of-illness studies on rare diseases defined as those with prevalence lower than 5 per 10,000 cases. Studies were selected by one researcher and verified by a second researcher. Methodological characteristics were extracted to develop a narrative synthesis. Results We included 63 cost-of-illness studies on 42 rare diseases conducted in 25 countries, and 9 systematic reviews. Most studies (94%) adopted a prevalence-based estimation, where the predominant design was cross-sectional with a bottom-up approach. Only four studies adopted an incidence-based estimation. Most studies used questionnaires to patients or caregivers to collect resource utilisation data (67%) although an important number of studies used databases or registries as a source of data (48%). Costs of lost productivity, non-medical costs and informal care costs were included in 68%, 60% and 43% of studies, respectively. Conclusion This review found a paucity of cost-of-illness studies in rare diseases. However, the analysis shows that the cost-of-illness studies of rare diseases are feasible, although the main issue is the lack of primary and/or aggregated data that often prevents a reliable estimation of the economic burden.

Inclusive education of disabled students has been promoted in European disability policies. However, the transition process from more segregated system is slow. The purpose of this study was to provide an insight about different types of schooling of disabled children affected by a rare disease across Europe and to evaluate their and caregivers' well-being. We analysed data from a cross-sectional study (BURQOL-RD) of persons with rare diseases that cause intellectual and/or physical disability: Prader-Willi syndrome, fragile X syndrome, three types of mucopolysaccharidosis and Duchenne muscular dystrophy. The sample consisted of 359 children aged 6-17 and 269 caregivers from eight European countries. Results showed differences between countries in proportion of students placed in special schools, which are still valid option in countries such as Germany, France or UK. Within the inclusive education modalities, lack of special support for disabled students was observed especially in low-income countries. No association between the type of schooling and quality of life was observed, but the subjective caregivers' burden seems to be higher in special schools. The study shows existent differences in implementation of inclusive education in Europe. More research is needed in the field of rare disease disability and educational needs.

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.Trial registration number NCT01657227.

Abstract Background Generalized anxiety disorder (GAD) is one of the most common mental disorders in primary care (PC). GAD has low remission and high relapse rates over long follow-up periods. Qualitative evidence was synthesized to understand the implementation of care and treatment options for people with GAD in PC. Methods Research published from 2008 to September 2020 was searched in five databases (MEDLINE, EMBASE, CINAHL, WOS and PsycArticles). Studies that used qualitative methods for data collection and analysis to investigate the implementation of care and treatment options for people with GAD in PC and outpatient settings were included. Non-qualitative studies, mixed methods studies that did not separately report qualitative findings and studies in languages other than English or Spanish were excluded. We used the Confidence in the Evidence from Reviews of Qualitative Research (CERQual) framework to assess the overall confidence in the findings. Results The results with a moderate level of confidence showed that the trajectory of care for people with GAD in PC and outpatient settings is long and fluctuates over time, involving multiple difficulties in accessing and maintaining initial treatment or successive treatment options. In addition, there are wide variations in the preferences for and acceptability of different treatment options. The results with a high level of confidence indicated that more information on GAD and its treatment options is needed for PC practitioners, GAD patients and their carers. The results with a low level of confidence suggested that patients use antidepressants for longer than recommended and that the interruption of treatment is not usually planned. Conclusions Initial resistance to new treatments among people with GAD can make access and adherence to treatment difficult. Improving care may require patients to be informed of possible trajectories in stepped care pathways before the initiation of treatment so they are aware that they may need to try a number of options until the most effective treatment for them is found. Increased awareness of and information materials on GAD may facilitate both appropriate diagnosis and long-term care.

Abstract Background Osteoarthritis (OA) is a health condition sensitive to patient’s preferences and values regarding the benefits and risks of the different treatment options. In this sense, patient decision aids (PtDA) can play an important role in helping patients to incorporate their values, needs, and preferences into the decision-making process, thus improving person-centered care. Previous research has focused almost exclusively on knee OA, and therefore, the aim of this study is to develop and evaluate the effectiveness of a PtDA for patients with hip OA. Methods The general design consists of two phases: (1) design a web-based PtDA for patients with hip OA, following the recommended procedures: systematic review of safety/effectiveness of treatments, and an iterative process of development with the help of an Advisory Committee composed of health professionals and patients, and (2) to evaluate the impact of the PtDA on hip OA patients’ decision-making process related with their treatment. For that aim, a multicenter randomized controlled trial will be carried out with 124 patients with hip OA in Tenerife (Spain) comparing intervention or usual care. Discussion PtDAs have been recommended as a useful and effective resource for improving PCC in many health conditions. The intervention is intended to empower patients by fostering their active participation during the decision-making process about their treatment and by ensuring they make informed decisions congruent with their values and preferences. This study will contribute to the scientific knowledge about effectiveness of PtDAs in hip OA, in order to improve the quality of health care offered to these patients. Trial registration ClinicalTrials.gov NCT04241978 . Registered on 24 January 2020.

Objective: In this study we conducted an economic evaluation of a surveillance programme to prevent hip dislocation in children with cerebral palsy. Method: We developed a model that compared costs and health outcomes of children with cerebral palsy with and without a surveillance programme. Information from a number of sources was combined into a decision analytical model, primarily based on data from a comparative study with a 20-year follow-up. Effectiveness was measured using Quality-Adjusted Life Years (QALYs). The analysis took the perspective of the Spanish National Health Service. We undertook extensive sensitivity analyses including a probabilistic sensitivity analysis. Results: The surveillance programme led to higher QALYs and higher health care costs, with an estimated incremental cost per QALY gained of 12,282€. The results were robust to model assumptions. The probability that the programme was cost-effective was estimated to be over 80% at the threshold of 25.000€/QALY recommended in Spain. Conclusion: This study indicates that surveillance programmes to prevent hip dislocation in children with cerebral palsy are likely to be cost-effective. Resumen: Objetivo: En este estudio se realiza una evaluación económica de un programa de vigilancia para prevenir la luxación de cadera en niños y niñas con parálisis cerebral. Método: Se desarrolló un modelo que comparó los costes y los resultados en salud de niños y niñas con parálisis cerebral incluidas y no incluidas en un programa de vigilancia. Se combinó la información proveniente de diversas fuentes en un modelo analítico de decisión, principalmente basado en datos de un estudio comparativo con 20 años de seguimiento. La efectividad se midió empleando los años de vida ajustados por calidad (AVAC). El análisis tomó la perspectiva del Sistema Nacional de Salud de España. Se realizó un extenso análisis de sensibilidad, incluyendo un análisis de sensibilidad probabilístico. Resultados: El programa de vigilancia estuvo asociado a más AVAC y mayores costes sanitarios, con un coste incremental por AVAC ganado estimado en 12.282 €. Los resultados fueron robustos a los supuestos del modelo. La probabilidad de que el programa fuera coste-efectivo se estimó en un valor por encima del 80% para el umbral de 25.000 € por AVAC recomendado en España. Conclusión: Este estudio indica que es probable que los programas de vigilancia para prevenir la luxación de cadera en niños y niñas con parálisis cerebral sean coste-efectivos.

The current COVID-19 pandemic is causing profound health, economic, and social problems worldwide. The global shortage of medical and personal protective equipment (PPE) in specialized centers during the outbreak demonstrated the need for efficient methods to disinfect and recycle them in times of emergency. We have previously described that high ozone concentrations destroyed viral RNA in an inactivated SARS-CoV-2 strain within a few minutes. However, the efficient ozone dosages for active SARS-CoV-2 are still unknown. The present study aimed to evaluate the systematic effects of ozone exposure on face masks from hospitalized patients infected with SARS-CoV-2. Face masks from COVID-19 patients were collected and treated with a clinical ozone generator at high ozone concentrations in small volumes for short periods. The study focused on SARS-CoV-2 gene detection (assessed by real-time quantitative polymerase chain reaction (RT-qPCR)) and on the virus inactivation by in vitro studies. We assessed the effects of different high ozone concentrations and exposure times on decontamination efficiency. We showed that high ozone concentrations (10,000, 2,000, and 4,000 ppm) and short exposure times (10, 10, and 2 minutes, respectively), inactivated both the original strain and the B.1.1.7 strain of SARS-CoV-2 from 24 contaminated face masks from COVID-19 patients. The validation results showed that the best condition for SARS-CoV-2 inactivation was a treatment of 4,000 ppm of ozone for 2 minutes. Further studies are in progress to advance the potential applications of these findings.

BackgroundSelf-management education is a fundamental aspect in the health care of people with diabetes to develop the necessary skills for the improvement of health outcomes. Patients are required to have the competencies to manage electronic information resources—that is, an appropriate level of digital health literacy. The European project IC-Health aimed to improve digital health literacy among people with diabetes through the cocreation of massive open online courses (MOOCs). ObjectiveWe report the preliminary results obtained in 3 participating countries in the IC-Health project (Italy, Spain, and Sweden) regarding (1) experience of the participants during the cocreation process of MOOCs, (2) perceived changes in their digital health literacy level after using MOOCs, and (3) a preliminary assessment of the acceptability of MOOCs. MethodsThe cocreation of the MOOCs included focus groups with adults and adolescents with diabetes and the creation of independent communities of practice for type 1 diabetes and type 2 diabetes participants aimed to co-design the MOOCs. Quantitative measures of the acceptability of MOOCs, experience in the cocreation process, and increase in digital health literacy (dimensions of finding, understanding, and appraisal) were assessed. ResultsA total of 28 participants with diabetes participated in focus groups. Adults and adolescents agreed that the internet is a secondary source of health-related information. A total of 149 participants comprised the diabetes communities of practice. A total of 9 MOOCs were developed. Acceptability of the MOOCs and the cocreation experience were positively valued. There was a significant improvement in digital health literacy in both adults and adolescents after using MOOCs (P

The artificial pancreas (AP) is equipped with a glucose monitoring sensor, an insulin pump and an integrated mathematical algorithm that determines insulin infusion based on the glucose levels detected by the sensor. Research has shown that AP can help patients with type-1 Diabetes Mellitus (T1DM) to improve the control of their glucose levels, but the occurrence of postprandial hyperglycemia is still considerable. The addition of pramlintide (a synthetic derivative analog of amylin) in a dual-hormone AP could improve postprandial glycemic control. This systematic review aims to evaluate and synthesize the evidence on the safety, efficacy and cost-effectiveness of the dual insulin- and pramlintide-releasing AP. The electronic databases MEDLINE, Embase, Web of Science and ClinicalTrials.gov were consulted up to 6 June 2021. We identified four small crossover studies (n = 59) and two ongoing crossover trials, all of them carried out by the same research group. The four studies observed more gastrointestinal adverse effects with the dual system. One study found that the dual system improved outcomes compared to insulin alone, with precise carbohydrate counting (CC) in both groups. Another study showed that a fully closed-loop system (without CC) was equivalent to an insulin-alone AP (with CC) on time in the target range but performed worse in hyperglycemia during the daytime. These preliminary results suggest that the control of postprandial hyperglycemia remains a challenge.

Abstract Background Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease with significant potential morbidity and mortality. Substantial gaps have been documented between the development and dissemination of clinical practice guidelines (CPG) and their implementation in practice. The aim of this study is to assess the effectiveness and cost-effectiveness of a multi-component knowledge transfer intervention to implement a CPG for the management of SLE (CPG-SLE). Methods The study is an open, multicentre, controlled trial with random allocation by clusters to intervention or control. Clusters are four public university hospitals of the Canary Islands Health Service where rheumatologists are invited to participate. Patients diagnosed with SLE at least one year prior to recruitment are selected. Rheumatologists in intervention group receive a short educational group programme to both update their knowledge about SLE management according to CPG-SLE recommendations and to acquire knowledge and training on use of the patient-centred approach, a decision support tool embedded in the electronic clinical record and a quarterly feedback report containing information on management of SLE patients. Primary endpoint is change in self-perceived disease activity. Secondary endpoints are adherence of professionals to CPG-SLE recommendations, health-related quality of life, patient perception of their participation in decision making, attitudes of professionals towards shared decision making, knowledge of professionals about SLE and use of healthcare resources. Calculated sample size is 412 patients. Data will be collected from questionnaires and clinical records. Length of follow-up will be 18 months. Multilevel mixed models with repeated time measurements will be used to analyze changes in outcomes over time. Cost-effectiveness, from both social and healthcare services perspectives, will be analyzed by measuring effectiveness in terms of quality-adjusted life years gained. Deterministic and probabilistic sensitivity analyses are planned. Discussion Impact of CPGs in clinical practice could be improved by applying proven value interventions to implement them. The results of this ongoing trial are expected to generate important scientifically valid and reproducible information not only on clinical effectiveness but also on cost-effectiveness of a multi-component intervention for implementation of a CPG based on communication technologies for chronic patients in the hospital setting. Trial registration ClinicalTrial.gov NCT03537638. Registered on 25 May 2018.

Abstract Background The objective of this study was to obtain utilities by means of EQ-5D-5L for different health states in patients with knee osteoarthritis (KOA) or hip osteoarthritis (HOA) in Spain, and to compare these values with those used in foreign studies with the aim of discussing their transferability for their use in economic evaluations conducted in Spain. Methods Primary study: Observational prospective study of KOA or HOA patients in Spain. Sociodemographic and clinical characteristics were collected to characterize the sample. Utilities were elicited using the EQ-5D-5L questionnaire. ANOVA and bivariable analyses were conducted to identify differences between health states. Literature review: Using the bibliographic databases NSH EED and CEA Registry, we conducted searches of model-based cost utilities analyses of technologies in KOA or HOA patients. Health states and utilities were extracted and compared with values obtained from the Spanish sample. Results Three hundred ninety-seven subjects with KOA and 361 subjects with HOA were included, with average utilities of 0.544 and 0.520, respectively. In both samples, differences were found in utilities according to level of pain, stiffness and physical function (WOMAC) and severity of symptoms (Oxford scales), so that the worst the symptoms, the lower the utilities. The utilities after surgery were higher than before surgery. Due to limitations from our study related to sample size and observational design, it was not possible to estimate utilities for approximately half the health states included in the published models because they were directly related to specific technologies. For almost 100% of health states of the selected studies we obtained very different utilities from those reported in the literature. Conclusions To our knowledge this is the first article with detailed utilities estimated using the EQ-5D-5L in Spain for KOA and HOA patients. In both populations, utilities are lower for worse health states in terms of level of pain, stiffness and physical function according to WOMAC, and according to the Oxford scales. Most utilities obtained from the Spanish sample are lower than those reported in the international literature. Further studies estimating utilities from local populations are required to avoid the use of foreign sources in economic evaluations.

Resumen: Introducción y objetivo: El radiodiagnóstico es esencial para precisar la planificación terapéutica de las personas con ictus, pero la incertidumbre sobre su efectividad puede contribuir a la variabilidad en su indicación. Este estudio tiene por objetivo describir la evolución del uso de TAC y RM en el manejo del ictus a lo largo de 5 años en la red hospitalaria del Servicio Canario de Salud y analizar la variabilidad interhospitalaria mediante el uso de datos administrativos recogidos rutinariamente. Pacientes y método: Se explotó el CMBD de los pacientes con diagnóstico de ictus o AIT (2005-2010) en 4 hospitales. Además, se incluyó la edad y el sexo del paciente, los procedimientos realizados, los diagnósticos secundarios y la estancia.Se realizó un análisis descriptivo de las características de los pacientes y un análisis bivariante mediante t de Student o Chi-cuadrado para detectar diferencias entre los pacientes según recibieran o no RM. Las desigualdades en el acceso a RM se analizaron mediante regresión logística. Resultados y conclusiones: Se incluyeron 10.487 pacientes adultos (8.571 con ictus y 1.916 con AIT). El porcentaje de pacientes con ictus que recibieron TAC aumentó desde el 89,47% en 2005 al 91,50% en 2010; en ellos, la RM aumentó desde el 25,41% en 2005 al 36,02% en 2010. Entre los pacientes con AIT el uso de TAC creció desde el 84,64 al 88,04%, y el de RM, desde el 32,53 al 39,13%. Nuestros resultados sugieren que ser mujer, joven y presentar mayor comorbilidad aumentan las probabilidades de recibir RM. Abstract: Introduction and objective: Imaging diagnosis is essential for treatment planning in stroke patients. However, use of these techniques varies due to uncertainty about their effectiveness. Our purpose was to describe the use of CT and MRI in stroke and transient ischaemic attack (TIA) over 5 years in hospitals belonging to the Canary Islands Health Service and analyse interhospital variability based on routinely collected administrative data. Patients and method: We gathered the minimum basic dataset (MBDS) from patients diagnosed with stroke or TIA between 2005 and 2010 in 4 hospitals. Patients’ age, sex, procedures, secondary diagnoses, and duration of hospital stay were also recorded.We conducted a descriptive analysis of patient characteristics and a bivariate analysis using the t test and the chi square test to detect differences between patients assessed and not assessed with MRI. Logistic regression was used to analyse unequal access to MRI. Results and conclusions: Our study included 10,487 patients (8,571 with stroke and 1,916 with TIA). The percentage of stroke patients undergoing a CT scan increased from 89.47% in 2005 to 91.50% in 2010. In these patients, use of MRI also increased from 25.41% in 2005 to 36.02% in 2010. Among patients with TIA, use of CT increased from 84.64% to 88.04% and MRI from 32.53% to 39.13%. According to our results, female sex, younger age, and presence of comorbidities increase the likelihood of undergoing MRI. Palabras clave: Variabilidad, Desigualdades, Pruebas de imagen, Ictus, Resonancia nuclear magnética, Tomografía axial computarizada, Keywords: Variability, Inequalities, Imaging techniques, Stroke, Magnetic resonance imaging, Computed tomography

Introduction and objective: Imaging diagnosis is essential for treatment planning in stroke patients. However, use of these techniques varies due to uncertainty about their effectiveness. Our purpose was to describe the use of CT and MRI in stroke and transient ischaemic attack (TIA) over 5 years in hospitals belonging to the Canary Islands Health Service and analyse interhospital variability based on routinely collected administrative data. Patients and method: We gathered the minimum basic dataset (MBDS) from patients diagnosed with stroke or TIA between 2005 and 2010 in 4 hospitals. Patients’ age, sex, procedures, secondary diagnoses, and duration of hospital stay were also recorded.We conducted a descriptive analysis of patient characteristics and a bivariate analysis using the t test and the chi square test to detect differences between patients assessed and not assessed with MRI. Logistic regression was used to analyse unequal access to MRI. Results and conclusions: Our study included 10 487 patients (8571 with stroke and 1916 with TIA). The percentage of stroke patients undergoing a CT scan increased from 89.47% in 2005 to 91.50% in 2010. In these patients, use of MRI also increased from 25.41% in 2005 to 36.02% in 2010. Among patients with TIA, use of CT increased from 84.64% to 88.04% and MRI from 32.53% to 39.13%. According to our results, female sex, younger age, and presence of comorbidities increase the likelihood of undergoing MRI. Resumen: Introducción y objetivo: El radiodiagnóstico es esencial para precisar la planificación terapéutica de las personas con ictus, pero la incertidumbre sobre su efectividad puede contribuir a la variabilidad en su indicación. Este estudio tiene por objetivo describir la evolución del uso de TAC y RM en el manejo del ictus a lo largo de 5 años en la red hospitalaria del Servicio Canario de Salud y analizar la variabilidad interhospitalaria mediante el uso de datos administrativos recogidos rutinariamente. Pacientes y método: Se explotó el CMBD de los pacientes con diagnóstico de ictus o AIT (2005-2010) en 4 hospitales. Además, se incluyó la edad y el sexo del paciente, los procedimientos realizados, los diagnósticos secundarios y la estancia.Se realizó un análisis descriptivo de las características de los pacientes y un análisis bivariante mediante t de Student o Chi-cuadrado para detectar diferencias entre los pacientes según recibieran o no RM. Las desigualdades en el acceso a RM se analizaron mediante regresión logística. Resultados y conclusiones: Se incluyeron 10.487 pacientes adultos (8.571 con ictus y 1.916 con AIT). El porcentaje de pacientes con ictus que recibieron TAC aumentó desde el 89,47% en 2005 al 91,50% en 2010; en ellos, la RM aumentó desde el 25,41% en 2005 al 36,02% en 2010. Entre los pacientes con AIT el uso de TAC creció desde el 84,64 al 88,04%, y el de RM, desde el 32,53 al 39,13%. Nuestros resultados sugieren que ser mujer, joven y presentar mayor comorbilidad aumentan las probabilidades de recibir RM. Keywords: Variability, Inequalities, Imaging techniques, Stroke, Magnetic resonance imaging, Computed tomography, Palabras clave: Variabilidad, Desigualdades, Pruebas de imagen, Ictus, Resonancia nuclear magnética, Tomografía axial computarizada

Abstract Background Colorectal cancer (CRC) screening has shown to reduce incidence and mortality rates, and therefore is widely recommended for people above 50 years-old. However, despite the implementation of population-based screening programs in several countries, uptake rates are still low. Decision aids (DAs) may help patients to make informed decisions about CRC screening. Methods We performed a randomized controlled trial to assess the effectiveness of a DA developed to promote CRC screening, with patients from two primary care centers in Spain who never had underwent CRC screening. Contrary to center B (n = 24), Center A (n = 83) attended patients from an area where the population-based screening program was not implemented at that moment. Outcome measures were decisional conflict, knowledge of the disease and available screening options, intention to uptake the test, and concordance between patients’ goals/concerns and intention. Results In center A, there were significant differences favoring the DA in decisional conflict (p

AA. VV. Fuente Ovejuna (1619-2019). Pervivencia de un mito universal. Edición de Javier Huerta Calvo. Coordinación de textos: Maša Kmet. New York, IDEA, 2019, 390 pp.

Introduction Patients with generalised anxiety disorder (GAD) have concerns and needs about their health and the healthcare they receive. Patient decision aids (PtDAs) are tools that assist patients in making health decisions, when there is uncertainty about treatment choice, incorporating their personal preferences and values about the available treatment options. PtDAs can improve shared decision-making and lead to better treatment outcomes. The aim of this study is to evaluate the effectiveness of a web-based PtDA for patients with GAD in primary care (PC).Methods and analysis The general study design is comprised of two stages: (1) development of a web-based PtDA for patients with GAD, derived from an evidence-based Clinical Practice Guideline and (2) assessment of the effectiveness of the PtDA in a randomised controlled trial (RCT) design, in PC centres in Tenerife (Spain). This RCT will be carried out with 124 patients with GAD, comparing the PtDA to a fact sheet with general information on mental health. Patients will review the PtDA in one session accompanied by a researcher. Post-intervention measures will be administered immediately after the intervention and at 3-month follow-up. The primary outcome will be decisional conflict. Secondary outcomes will include knowledge about GAD and its treatment, treatment preference, concordance between treatment preference and choice, and decision quality (knowledge ≥60% and concordant decision).Ethics and dissemination The project received ethics approval from the local committee at Nuestra Señora de la Candelaria (HUNSC) University Hospital in Santa Cruz de Tenerife (code: CHUNSC_2019_58). Informed consent will be obtained from each participant before randomisation. Results from the trial will be submitted for publication in international peer-reviewed scientific journals and will be disseminated through workshops and local and international conferences.Trial registration number NCT04364958.

BackgroundType 2 diabetes mellitus (T2DM) is a chronic disease in which health outcomes are related to decision making by patients and health care professionals. ObjectiveThis 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. MethodsThe 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. ResultsFor 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. ConclusionsIn 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. Trial RegistrationClinicalTrials.gov NCT01657227; https://clinicaltrials.gov/ct2/show/NCT01657227

Reseña de Miguel F. Gil Palacios (ed.) (2019), Generación Romero Esteo, monográfico de Recherches. Culture et histoire dans l’espace roman, 22, Estrasburgo, Universidad de Estrasburgo.

Abstract Background Though breast cancer remains a major health problem, there is a lack of information on health care provided to patients with this disease and associated costs. In addition, there is a need to update and validate risk stratification tools in Spain. Our purpose is to evaluate the health services provided for breast cancer in Spain, from screening and diagnosis to treatment and prognosis. Methods Prospective cohort study involving 13 hospitals in Spain with a follow-up period of up to 5 years after diagnostic biopsy. Eligibility criteria: Patients diagnosed with breast cancer between April 2013 and May 2015 that have consented to participate in the study. Data collection: Data will be collected on the following: pre-intervention medical history, biological, clinical, and sociodemographic characteristics, mode of cancer detection, hospital admission, treatment, and outcomes up to 5 years after initial treatment. Questionnaires about quality of life (EuroQoL EQ-5D-5 L, the European Organization For Research And Treatment Of Cancer Core Quality Of Life Questionnaire EORTC QLQ-C30 join to the specific breast cancer module (QLQ-BR23), as well as Hospital Anxiety and Depression Scale were completed by the patients before the beginning of the initial treatment and at the end of follow-up period, 2 years later. The end-points of the study were changes in health-related quality of life, recurrence, complications and readmissions at 2 and 5 years after initial treatment. Statistical analysis: Descriptive statistics will be calculated and multivariate models will be used where appropriate to adjust for potential confounders. In order to create and validate a prediction model, split validation and bootstrapping will be performed. Cost analysis will be carried out from the perspective of a national health system. Discussion The results of this coordinated project are expected to generate scientifically valid and clinically and socially important information to inform the decision-making of managers and the authorities responsible for ensuring equality in care processes as well in health outcomes. For clinicians, clinical prediction rules will be developed which are expected to serve as the basis for the development of software applications. Trial registration NCT02439554 . Date of registration: May 8, 2015 (retrospectively registered) .

Resumen: Introducción: El deterioro progresivo de los pacientes con ataxias espinocerebelosas (AEC) genera un gran impacto sobre su calidad de vida relacionada con la salud (CVRS). En este estudio se evalúa la CVRS en una muestra de pacientes diagnosticados de AEC y se pretende estimar la capacidad predictiva de un conjunto de variables sociodemográficas en las distintas dimensiones que conforman el cuestionario. Métodos: Se evaluó a un total de 80 pacientes diagnosticados de AEC, a través de un cuestionario sociodemográfico y del cuestionario genérico de salud SF-36. Se estudiaron variables sociodemográficas como sexo, edad, existencia de cuidador, situación laboral y tiempo desde el diagnóstico de la enfermedad. Resultados: Las dimensiones que componen el SF-36 muestran correlaciones positivas y significativas entre ellas. Las puntuaciones medias obtenidas en cada una de las dimensiones difieren según el sexo, siendo significativa la diferencia solo en la dimensión salud general, con media más alta en los hombres. En relación con la edad, se encuentran diferencias significativas en las dimensiones vitalidad y función social, con puntuaciones mayores en el rango de menor edad (menores de 34 años). La variable que explica la mayor parte de la varianza del cuestionario es la existencia de cuidador. Conclusiones: El Cuestionario de Salud SF-36 es un instrumento válido y fiable para medir la CVRS en pacientes con diagnóstico de AEC. Asimismo, la variable existencia de cuidador parece determinar la calidad de vida autopercibida por estos pacientes. Abstract: Introduction: The progressive deterioration of patients with spinocerebellar ataxia (SCA) has a major impact on their health-related quality of life (HRQOL). This study evaluates HRQOL in a sample of patients diagnosed with SCA and aims to estimate the predictive ability of a set of sociodemographic variables for the different dimensions of the General Health Questionnaire. Methods: A total of 80 patients diagnosed with SCA were assessed using a sociodemographic questionnaire and the SF-36 General Health Questionnaire. The sociodemographic variables studied were sex, age, presence of a carer, employment status, and time elapsed from diagnosis of the disease. Results: The 8 subscales of the SF-36 show positive and significant correlations to one another. Mean scores obtained on each SF-36 subscale differ between women and men, although this difference is significant only on the general health subscale, with men scoring higher than women. We found significant age differences on the vitality and social function subscales, with higher scores among younger patients (

Introduction: The progressive deterioration of patients with spinocerebellar ataxia (SCA) has a major impact on their health-related quality of life (HRQOL). This study evaluates HRQOL in a sample of patients diagnosed with SCA and aims to estimate the predictive ability of a set of sociodemographic variables for the different dimensions of the General Health Questionnaire. Methods: A total of 80 patients diagnosed with SCA were assessed using a sociodemographic questionnaire and the SF-36 General Health Questionnaire. The sociodemographic variables studied were sex, age, presence of a carer, employment status, and time elapsed from diagnosis of the disease. Results: The 8 subscales of the SF-36 show positive and significant correlations to one another. Mean scores obtained on each SF-36 subscale differ between women and men, although this difference is significant only on the general health subscale, with men scoring higher than women. We found significant age differences on the vitality and social function subscales, with higher scores among younger patients (

Background: The aim of this study was to assess whether daptomycin is safer and more efficacious than comparators for the treatment of serious infection caused by gram-positive microorganisms. Methods: Electronic databases (Medline, EMBASE, the Cochrane Central Register of Controlled Trials and clinical registered trials) were searched to identify randomized controlled trials (RCTs) that assessed the efficacy and safety of daptomycin versus therapy with any other antibiotic comparator. Two reviewers independently applied selection criteria, performed a quality assessment and extracted the data. Heterogeneity was assessed, and a random-effects or fixed-effects model, when appropriate, was used for estimates of risk ratio (RR). The primary outcome assessed was the risk of clinical treatment failure among the intention-to-treat population and the presence of any treatment related adverse event (AEs). Results: A total of seven trials fulfilled the inclusion criteria. Daptomycin treatment failure rates were no different to comparator regimens (RR = 0.96; CI 95% 0.86–1.06). No significantly different treatment related AEs were identified when comparing groups (RR = 0.91; CI 95% 0.83–1.01). Conclusions: No significant differences in treatment failure rates and safety were found using daptomycin or any of the comparators treatment.

The aim of present study was to evaluate the prevalence of gastrointestinal parasite infection and related factors that govern prevalence in pet dogs. Of 200 fecal samples screened, a prevalence of 39% was observed, in which Toxocara canis (37%) and coccidian (29%) were predominant. Factors that could be associated with an increase in the probability of parasite detection in fecal samples included time since the last deworming, sex, and breed. Pet dogs with > 6 months since the last deworming had a 1.5 times higher probability (P 6 months since last deworming, purebred, and male dogs exhibited a comparatively higher prevalence and probability of gastrointestinal parasite infection.