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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.

Miguel Angel Pérez-Silguero,1 David Pérez-Silguero,2 Amado Rivero-Santana,3 Maria Inmaculada Bernal-Blasco,4 Pablo Encinas-Pisa1 1Department of Ophthalmology, La Paloma Hospital, Las Palmas de Gran Canaria, Canary Islands, Spain; 2Department of Ophthalmology, Pérez-Silguero Ophthalmologic Clinic, Las Palmas de Gran Canaria, Canary Islands, Spain; 3Department of Health Technology Assessment, Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC), Las Palmas de Gran Canaria, Canary Islands, Spain; 4Department of Community and Family Medicine, Primary Care Center of Cuevas Torres, Las Palmas de Gran Canaria, Canary Islands, SpainCorrespondence: Amado Rivero-SantanaServicio de Evaluación del Servicio Canario de la Salud, Camino Candelaria, 44, El Rosario, S/C de Tenerife, 38109, SpainTel +34 922478269Email amado.riverosantana@sescs.esPurpose: To assess the effectiveness of a combination of intense pulsed light and low-level light therapy (IPL/LLLT) for the treatment of dry eye.Study Design: Retrospective before-after single-center clinical study.Materials and Methods: Patients diagnosed with dry eye, refractory to conventional treatment, underwent four sessions of combined IPL/LLLT over 3 months. The Ocular Surface Disease Index (OSDI) questionnaire, non-invasive breakup time (NIBUT), tear film osmolarity and meniscus height were measured 6 months before intervention, at baseline, post-intervention (3 months), 9 and 15 months.Results: NIBUT, osmolarity and meniscus height significantly worsened during the 6 months before treatment, whereas symptoms did not change. OSDI scores significantly improved at post-intervention (MD = − 44.0, 95% CI − 38.1, − 50.0), and then increased again until the at last follow-up, but still significantly different from baseline (MD = − 30.0, 95% CI − 23.4, − 36.8). The three clinical signs showed a similar pattern, with one-year improvements of 3.6 seconds for the NIBUT (95% CI 3.1, 4.2, p < 0.001), 28 mOsm/L for osmolarity (95% CI 23.6, 32.4, p < 0.001) and 0.03 mm for meniscus height (95% CI 0.02, 0.04, p < 0.001). No adverse effects were observed.Conclusion: IPL/LLLT is safe and produces an important reduction in symptoms and signs of dry eye disease, still relevant one year after the end of treatment in a sample with high symptoms’ severity. Therefore, it represents a promising treatment option for patients who do not improve with conventional treatment. Randomized trials are needed to determine the added benefit provided by LLLT.Keywords: dry eye, meibomian gland dysfunction, intense pulsed light, low-level light therapy, retrospective study

Amado Rivero-Santana,1 Lilisbeth Perestelo-Perez,2,3 Jeanette Pérez-Ramos,1 Pedro Serrano-Aguilar,2,3 Carlos De las Cuevas2,4 1Canary Islands Foundation of Health and Research, 2Red de Investigacion en Servicios de Salud en Enfermedades Cronicas (REDISSEC), Santa Cruz de Tenerife, 3Evaluation Unit, Canary Islands Health Service, Santa Cruz de Tenerife, 4Department of Psychiatry, University of La Laguna, Canary Islands, Spain Background: The literature shows that compliance with antidepressant treatment is unsatisfactory. Several personal and disease-related variables have been shown to be related to compliance behavior. The objective of this study was to review the literature about sociodemographic and clinical predictors of compliance in patients with depressive disorders. Methods: The Medline, Embase, Cochrane Central, PsycInfo, and Cinahl databases were searched until May 2012. Studies that analyzed sociodemographic and clinical predictors or correlates of compliance in patients with depressive disorder were included. A quantitative synthesis was not performed because of the heterogeneity and availability of the data reported. For similar reasons, the results were not classified according to the different phases of treatment. The search was limited to studies published in English and Spanish. Results: Thirty-two studies fulfilled the inclusion criteria. The most consistent associations with compliance were found for age (older patients showed more compliance) and race (white patients were more likely to adhere to treatment than minority ethnic groups). Few studies assessed clinical factors, and the most plausible predictors of compliance were certain comorbidities and substance abuse. Severity of depression did not play an important role in predicting compliance. Conclusion: The impact of the variables studied on compliance behavior appeared to be inconsistent. Identifying potential predictors of compliance with antidepressant treatment is important, both for the routine practice of the mental health professional and for refining interventions to enhance adherence and target them to specific populations at risk of noncompliance. Keywords: adherence, antidepressants, compliance, depression, predictors

Abstract Background Concordance and Shared Decision-Making (SDM) are considered measures of the quality of care that improves communication, promotes patient participation, creates a positive relationship with the healthcare professional, and results in greater adherence with the treatment plan. Methods This study compares the attitudes of 225 mental health professionals (125 psychiatrists and 100 psychiatry registrars) and 449 psychiatric outpatients towards SDM and concordance in medicine taking by using the "Leeds Attitude toward Concordance Scale" (LATCon). Results The internal consistency of the scale was good in all three samples (Cronbach's α: patients = 0.82, psychiatrists = 0.76, and registrars = 0.82). Patients scored significantly lower (1.96 ± 0.48) than professionals (P Conclusions We observed a positive attitude towards concordance in the field of psychotropic drugs prescription both in professionals and among patients, but further studies are needed to address the extent to which this apparently accepted model is reflected in the daily practice of mental health professionals.

Introduction: Current evidence reveals concerning rates of non-adherence to antidepressant treatment, possibly influenced by various relevant determinants such as sociodemographic factors or those related to the health system and their professionals. The aim of this paper is to review the scientific evidence on sociodemographic and clinical predictors of adherence to pharmacological treatment in patients diagnosed with a depressive disorder.Methods: a systematic review (SR) was conducted. The search for a previous SR was updated and de novo searches were performed in Medline, EMBASE, Web of Science (WoS) and PsycInfo (last 10 years). The risk of bias was assessed using the Cochrane tool for non-randomized studies—of Exposure (ROBINS-E). Meta-analyses were conducted.Results: Thirty-nine studies (n = 2,778,313) were included, 24 of them in the meta-analyses. In the initiation phase, no association of adherence was found with any of the predictors studied. In the implementation and discontinuation phases, middle-aged and older patients had better adherence rates and lower discontinuation rates than younger ones. White patients adhered to treatment better than African-American patients.Discussion: Age and ethnicity are presented as the predictive factors of pharmacological adherence. However, more research is needed in this field to obtain more conclusive results on other possible factors.Systematic Review Registration: [https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023414059], identifier [CRD42023414059]

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.

In Long COVID, dysfunction in the pituitary–adrenal axis and alterations in immune cells and inflammatory status are warned against. We performed a prospective study in a cohort of 42 patients who suffered COVID-19 at least 6 months before attending the Long COVID unit at Althaia Hospital. Based on Post-COVID Functional Status, 29 patients were diagnosed with Long COVID, while 13 were deemed as recovered. The hormones of the pituitary–adrenal axis, adrenocorticotropin stimulation test, and immune cell profiles and inflammatory markers were examined. Patients with Long COVID had significantly lower EuroQol and higher mMRC scores compared to the recovered individuals. Their symptoms included fatigue, myalgia, arthralgia, persistent coughing, a persistent sore throat, dyspnoea, a lack of concentration, and anxiety. We observed the physiological levels of cortisol and adrenocorticotropin in individuals with or without Long COVID. The results of the adrenocorticotropin stimulation test were similar between both groups. The absolute number of neutrophils was lower in the Long COVID patients compared to recovered individuals (p < 0.05). The total count of B lymphocytes remained consistent, but Long COVID patients had a higher percentage of mature B cells compared to recovered participants (p < 0.05) and exhibited a higher percentage of circulating resident memory CD8+ T cells (p < 0.05) and Treg-expressing exonucleases (p < 0.05). Our findings did not identify adrenal dysfunction related to Long COVID, nor an association between adrenal function and clinical symptoms. The data indicated a dysregulation in certain immune cells, pointing to immune activation. No overt hyperinflammation was observed in the Long COVID group.

PURPOSE We aimed to evaluate the effectiveness of a virtual community of practice (vCoP) in improving primary health care professionals' (HCPs') attitudes toward empowering patients with chronic disease. METHODS We conducted a cluster randomized controlled trial. Practices were units of randomization, and primary HCPs and patients were units of analysis. Sixty-three practices in Madrid, Catalonia, and the Canary Islands were randomly allocated to the intervention or control groups. Randominzation of practices was performed after HCP and patient recruitment. The patients and statistician were anonymized to group allocation; it was not possible to anonymize HCPs. The intervention was a 12-month multicomponent tailored vCoP built on the Web 2.0 concept and focused on skills toward patient empowerment. The primary outcome was Patient-Provider Orientation Scale (PPOS) score at baseline and at 12 months. The secondary outcome was the Patient Activation Measure (PAM) score. RESULTS A total of 321 HCPs and 1,921 patients were assessed. The intervention had a positive effect on PPOS total score (0.14 points higher in the vCoP arm; 95% CI, 0.03-0.25; P = .011) and the PPOS Sharing subscale (0.3 points higher in the vCoP arm; 95% CI, 0.150.44; P < .001). No effect was found for the PPOS Caring subscale, and no significant differences were found for PAM scores. CONCLUSIONS A vCoP led to a minor increase in the PPOS Sharing component and the total score but not in the Caring component. However, considerable uncertainty remains, given the observed attrition and other limitations of the study. Further research is needed on the effectiveness of the vCoP model and on how to improve HCP engagement. Key words: patient empowerment; chronic diseases; patient-centered care; virtual community of practice Ann Fam Med 2022;20:204-210. https://doi.org/10.1370/afm.2799, INTRODUCTION The high burden for health care systems that is associated with chronic care could be decreased by boosting patient empowerment. (1) Empowered patients take action to improve their quality [...]

Background and Aims Baseline cardiovascular toxicity risk stratification is critical in cardio-oncology. The Heart Failure Association (HFA) and International Cardio-Oncology Society (ICOS) score aims to assess this risk but lacks real-life validation. This study validates the HFA-ICOS score for anthracycline-induced cardiovascular toxicity. Methods Anthracycline-treated patients in the CARDIOTOX registry (NCT02039622) were stratified by the HFA-ICOS score. The primary endpoint was symptomatic or moderate to severe asymptomatic cancer therapy-related cardiac dysfunction (CTRCD), with all-cause mortality and cardiovascular mortality as secondary endpoints. Results The analysis included 1066 patients (mean age 54 ± 14 years; 81.9% women; 24.5% ≥65 years). According to the HFA-ICOS criteria, 571 patients (53.6%) were classified as low risk, 333 (31.2%) as moderate risk, 152 (14.3%) as high risk, and 10 (0.9%) as very high risk. Median follow-up was 54.8 months (interquartile range 24.6–81.8). A total of 197 patients (18.4%) died, and 718 (67.3%) developed CTRCD (symptomatic: n = 45; moderate to severe asymptomatic: n = 24; and mild asymptomatic: n = 649). Incidence rates of symptomatic or moderate to severe symptomatic CTRCD and all-cause mortality significantly increased with HFA-ICOS score [hazard ratio 28.74, 95% confidence interval (CI) 9.33–88.5; P <.001, and hazard ratio 7.43, 95% CI 3.21–17.2; P <.001) for very high-risk patients. The predictive model demonstrated good calibration (Brier score 0.04, 95% CI 0.03–0.05) and discrimination (area under the curve 0.78, 95% CI 0.70–0.82; Uno's C -statistic 0.78, 95% CI 0.71–0.84) for predicting symptomatic or severe/moderate asymptomatic CTRCD at 12 months. Conclusions The HFA-ICOS score effectively categorizes patients by cardiovascular toxicity risk and demonstrates strong predictive ability for high-risk anthracycline-related cardiovascular toxicity and all-cause mortality. [ABSTRACT FROM AUTHOR]

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.

Background: Patients with cardiogenic shock (CS) and mitral regurgitation (MI) have a prohibitive risk that contraindicates surgical treatment. Although the feasibility of transcatheter edge-to-edge therapy (TEER) has been demonstrated in this setting, the benefit of the combined use of TEER with mechanical circulatory support devices (MCS) has not been studied. The aim of this study was to evaluate the clinical outcomes of TEER in patients with MCS. Methods: The MITRA-ASSIST study is a retrospective multicentre Spanish registry that included patients with MR and CS who underwent TEER in combination with MCS. The primary endpoint was death from any cause at 12 months. The secondary endpoint was a composite of death from any cause or hospitalisation for heart failure at 12 months. Results: A total of twenty-four patients in nine high-volume Spanish centres (66.2 (51–82) years, 70.8% female, EuroSCORE II 20.4 ± 17.8) were included. Acute ST-elevation myocardial infarction was the main CS aetiology (56%), and the most implanted MCS was the intra-aortic balloon pump (82.6%), followed by ECMO (8.7%), IMPELLACP® (4.3%), or a combination of both (4.3%). Procedural success was 95.8%, with 87.5% in-hospital survival. At 12-month follow-up, 25.0% of patients died, and 33.3% had a composite event of death from any cause or hospitalisation for heart failure. Conclusions: TEER in patients with concomitant CS and MR who require MCS appears to be a promising therapeutic alternative with a high device procedural success rate and acceptable mortality and heart failure readmission rates at follow-up. [ABSTRACT FROM AUTHOR]

Trans* people frequently report attitudes of prejudice/transphobia in health professionals. Conversely, health professionals indicate the lack of adequate training to care for these people and its impact on the quality of care provided. Objective: Our objective was to evaluate the explicit prejudices/transphobia of health students and professionals and compare them with the general population in Tenerife. Methods: A descriptive cross-sectional study was carried out with the Genderism and Transphobia Scale (GTS) and the Negative Attitude towards Trans* people Scale (EANT) with a total of 602 participants. Results: We found a low mean level of explicit prejudice/transphobia, with little/no differences between occupation groups. Explicit transphobia was correlated with being a man, less educated, and heterosexual, and not personally knowing a trans* person. Men and women were less transphobic about trans* people whose identities coincided with their own. Conclusion: All participants showed a low mean level of explicit transphobia. This result is not incompatible with unconscious prejudice, which may translate to discriminatory behaviors. Interventions to change negative attitudes are still needed, since even a small percentage of transphobic health professionals could exert a considerable negative impact on health care. In professionals without transphobic attitudes, the barriers identified by trans* people might be a problem due to the lack of specific training.

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.

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.

Introduction: Suicide poses a severe public health challenge worldwide, impacting individuals, families, work, and society. The multifaceted nature of suicide demands a complex approach involving psychological, biological, social, cultural, and environmental factors. Recognizing suicide's status as the leading external cause of death in Spain, prevention increasingly incorporates technology, specifically mobile and software applications. Methods: A systematic review of the effectiveness and safety of mobile and software applications was conducted (MEDLINE, Embase, CINAHL, and PsycINFO databases). Outcome variables included: suicide; suicidal behavior; suicidal intent; suicidal ideation/thinking; self-perceived suicide risk; using/seeking mental health services; associated mental symptoms; mental health-related quality of life; satisfaction of the user and the health professional; adverse events related to the app, as defined in the included studies. Studies that do not include suicidal behavior, intention, or ideation were excluded. Where available data allowed, a meta-analysis was conducted for each outcome variable. Results: One systematic review and 13 randomized controlled trials (n=2,952) were analyzed. No significant differences were found in deaths by suicide or suicide attempts. At post-intervention, small but significant reductions were observed in suicidal ideation, hopelessness, depression, and worry, with anxiety reduction slightly above statistical significance. At follow-up (8 to 52 weeks), these variables also obtained significant results, except depression and suicidal ideation. Regarding safety, there was no significant difference in safety phone calls for participants with suicidal ideation. Conclusions: The evidence on suicide prevention app effectiveness is of low quality, precluding conclusive findings. Attempt reduction is suggested at 21 percent, but the confidence interval includes a potential 60 percent increase. Evidence on suicide-related psychological variables (suicide ideation, depression, hopelessness, and anxiety) is of higher quality (low–moderate), but effects are small and clinically uncertain. Safety findings are uncertain, impacting risk/benefit balance. [ABSTRACT FROM AUTHOR]