Evaluation of adherence to antipsychotics: A real-world data study using four different dosing assumptions.

AIMS: This study aimed to assess the frequency of dosing inconsistencies in prescription data and the effect of four dosing assumption strategies on adherence estimates for antipsychotic treatment. METHODS: A retrospective cohort, which linked prescription and dispensing data of adult patients with ≥1 antipsychotic prescription between 2015-2016 and followed up until 2019, in Catalonia (Spain). Four strategies were proposed for selecting the recommended dosing in overlapping prescription periods for the same patient and antipsychotic drug: (i) the minimum dosing prescribed; (ii) the dose corresponding to the latest prescription issued; (iii) the highest dosing prescribed; and (iv) all doses included in the overlapped period. For each strategy, one treatment episode per patient was selected, and the Continuous Medication Availability measure was used to assess adherence. Descriptive statistics were used to describe results by strategy. RESULTS: Of the 277 324 prescriptions included, 76% overlapped with other prescriptions (40% with different recommended dosing instructions). The number and characteristics of patients and treatment episodes (18 292, 18 303, 18 339 and 18 536, respectively per strategy) were similar across strategies. Mean adherence was similar between strategies, ranging from 57 to 60%. However, the proportion of patients with adherence ≥90% was lower when selecting all doses (28%) compared with the other strategies (35%). CONCLUSION: Despite the high prevalence of overlapping prescriptions, the strategies proposed did not show a major effect on the adherence estimates for antipsychotic treatment. Taking into consideration the particularities of antipsychotic prescription practices, selecting the highest dose in the overlapped period seemed to provide a more accurate adherence estimate.

Cost Analysis of Low-Volume Versus Standard-Volume Ultrasound-Guided Interscalene Brachial Plexus Block in Arthroscopic Shoulder Surgery.

Background Economic evaluation has become an essential decision-making tool for health systems worldwide. This study was aimed at estimating the difference in the use of healthcare resources, days on sick leave, and costs between patients undergoing a standard-volume versus a low-volume ultrasound-guided interscalene brachial plexus block. Methods This is a post-hoc cost analysis of a double-blind, randomized, and controlled clinical trial. Forty-eight patients undergoing ultrasound-guided interscalene block received either 10 ml or 20 ml of levobupivacaine 0.25%. Analyses involved the public healthcare payer perspective (including visits to general practitioners, nursing staff, physiotherapy facilities, hospital admissions, outpatient diagnostic tests, etc.) and the limited societal perspective, including productivity losses (days on sick leave). Measurements were made at one-month and one-year follow-ups post-intervention. Differences in costs were estimated using two-part models adjusted by the costs incurred in the previous year. Results Subjects in the 10 ml group made greater use of general practitioner visits (mean difference [95% CI]: 3.35 [0.219 to 6.49]; p=0.036) and diagnostic tests (2.43 [0.601 to 4.26]; p=0.009), but less use of physical therapy (-12.9 [-21.7 to -4.06]; p=0.004). Mean (SD) cost differences from the public healthcare payer's perspective were 1,461.34 $ (1,541.62) and 1,024.08$ (943.83) for the 10 ml and 20 ml groups, respectively (p=0.293). From the limited societal perspective, the differences were as follows: 7,036.53$ (8,077.58) and 8,666.56$ (9,841.10), respectively (p=0.937). While there were no differences in the above parameters at the one-month follow-up. Conclusion The volume reduction proposed following interscalene block resulted in meaningful, albeit not statistically significant, clinical benefits and lower costs from a limited societal perspective for shoulder surgery. Thus, healthcare use and days on sick leave are variables to be taken into consideration when calculating the economic impact of surgical procedures.

Improving Initial Medication Adherence to cardiovascular disease and diabetes treatments in primary care: Pilot trial of a complex intervention.

Introduction: The Initial Medication Adherence (IMA) intervention is a multidisciplinary and shared decision-making intervention to improve initial medication adherence addressed to patients in need of new treatments for cardiovascular diseases and diabetes in primary care (PC). This pilot study aims to evaluate the feasibility and acceptability of the IMA intervention and the feasibility of a cluster-RCT to assess the effectiveness and cost-effectiveness of the intervention. Methods: A 3-month pilot trial with an embedded process evaluation was conducted in five PC centers in Catalonia (Spain). Electronic health data were descriptively analyzed to test the availability and quality of records of the trial outcomes (initiation, implementation, clinical parameters and use of services). Recruitment and retention rates of professionals were analyzed. Twenty-nine semi-structured interviews with professionals (general practitioners, nurses, and community pharmacists) and patients were conducted to assess the feasibility and acceptability of the intervention. Three discussion groups with a total of fifteen patients were performed to review and redesign the intervention decision aids. Qualitative data were thematically analyzed. Results: A total of 901 new treatments were prescribed to 604 patients. The proportion of missing data in the electronic health records was up to 30% for use of services and around 70% for clinical parameters 5 months before and after a new prescription. Primary and secondary outcomes were within plausible ranges and outliers were barely detected. The IMA intervention and its implementation strategy were considered feasible and acceptable by pilot-study participants. Low recruitment and retention rates, understanding of shared decision-making by professionals, and format and content of decision aids were the main barriers to the feasibility of the IMA intervention. Discussion: Involving patients in the decision-making process is crucial to achieving better clinical outcomes. The IMA intervention is feasible and showed good acceptability among professionals and patients. However, we identified barriers and facilitators to implementing the intervention and adapting it to a context affected by the COVID-19 pandemic that should be considered before launching a cluster-RCT. This pilot study identified opportunities for refining the intervention and improving the design of the definitive cluster-RCT to evaluate its effectiveness and cost-effectiveness. Clinical trial registration: ClinicalTrials.gov, identifier NCT05094986.

Improving equity in access to early diagnosis of cancer in different healthcare systems of Latin America: protocol for the EquityCancer-LA implementation-effectiveness hybrid study.

INTRODUCTION: Healthcare fragmentation, a main cause for delay in cancer diagnosis and treatment, contributes to high mortality in Latin America (LA), particularly among disadvantaged populations. This research focuses on integrated care interventions, which have been limitedly implemented in the region. The objective is to evaluate the contextual effectiveness of scaling-up an integrated care intervention to improve early diagnosis of frequent cancers in healthcare networks of Chile, Colombia and Ecuador. METHODS AND ANALYSIS: This research is two pronged: (A) quasi-experimental design (controlled before and after) with an intervention and a control healthcare network in each LA country, using an implementation-effectiveness hybrid approach to assess the intervention process, effectiveness and costs; and (B) case study design to analyse access to diagnosis of most frequent cancers. Focusing on the most vulnerable socioeconomic population, it develops in four phases: (1) analysis of delays and barriers to early diagnosis (baseline); (2) intervention adaptation and implementation (primary care training, fast-track referral pathway and patient information); (3) intracountry evaluation of intervention and (4) cross-country analysis. Baseline and evaluation studies adopt mixed-methods qualitative (semistructured individual interviews) and quantitative (patient questionnaire survey) methods. For the latter, a sample size of 174 patients with cancer diagnosis per healthcare network and year was calculated to detect a proportions difference of 15%, before and after intervention (α=0.05; ß=0.2) in a two-sided test. A participatory approach will be used to tailor the intervention to each context, led by a local steering committee (professionals, managers, policy makers, patients and researchers). ETHICS AND DISSEMINATION: This study complies with international and national legal stipulations on ethics. It was approved by each country's ethical committee and informed consent will be obtained from participants. Besides the coproduction of knowledge with key stakeholders, it will be disseminated through strategies such as policy briefs, workshops, e-tools and scientific papers.

Costs and Factors Associated with Hospitalizations Due to Severe Influenza in Catalonia (2017-2020).

This study aimed to estimate the cost and factors associated with severe hospitalized patients due to influenza in unvaccinated and vaccinated cases. The study had a cross-sectional design and included three influenza seasons in 16 sentinel hospitals in Catalonia, Spain. Data were collected from a surveillance system of influenza and other acute respiratory infections. Generalized linear models (GLM) were used to analyze mean costs stratified by comorbidities and pregnancy. Multivariate logistic models were used to analyze bacterial coinfection, multi-organ failure, acute respiratory distress syndrome, death and ICU admission by season and by vaccination status. Costs of ICU, hospitalization and total mean costs were analyzed using GLM, by season and by vaccination status. All models were adjusted for age and sex. A total of 2742 hospitalized cases were included in the analyses. Cases were mostly aged ≥ 60 years (70.17%), with recommended vaccination (86.14%) and unvaccinated (68.05%). The ICU admission level was statistically significant higher in unvaccinated compared to vaccinated cases. Costs of cases with more than or equal to two comorbidities (Diff = EUR - 1881.32), diabetes (Diff = EUR - 1953.21), chronic kidney disease (Diff = EUR - 2260.88), chronic cardiovascular disease (Diff = EUR - 1964.86), chronic liver disease (Diff = EUR - 3595.60), hospitalization (EUR 9419.42 vs. EUR 9055.45), and total mean costs (EUR 11,540.04 vs. 10,221.34) were statistically significant higher in unvaccinated compared to vaccinated patients. The influenza vaccine reduces the costs of hospitalization. There is a need to focus strategies in recommended vaccination groups.

Complex multidisciplinary intervention to improve Initial Medication Adherence to cardiovascular disease and diabetes treatments in primary care (the IMA-cRCT study): mixed-methods process evaluation protocol.

INTRODUCTION: Medication non-initiation, or primary non-adherence, is a persistent public health problem that increases the risk of adverse clinical outcomes. The initial medication adherence (IMA) intervention is a complex multidisciplinary intervention to improve adherence to cardiovascular and diabetes treatments in primary care by empowering the patient and promoting informed prescriptions based on shared decision-making. This paper presents the development and implementation strategy of the IMA intervention and the process evaluation protocol embedded in a cluster randomised controlled trial (the IMA-cRCT) to understand and interpret the outcomes of the trial and comprehend the extent of implementation and fidelity, the active mechanisms of the IMA intervention and in what context the intervention is implemented and works. METHODS AND ANALYSIS: We present the protocol for a mixed-methods process evaluation including quantitative and qualitative methods to measure implementation and fidelity and to explore the active mechanisms and the interactions between the intervention, participants and its context. The process evaluation will be conducted in primary care centres and community pharmacies from the IMA-cRCT, and participants include healthcare professionals (general practitioners, nurses and community pharmacists) as well as patients. Quantitative data collection methods include data extraction from the intervention operative records, patient clinical records and participant feedback questionnaires, whereas qualitative data collection involves semistructured interviews, focus groups and field diaries. Quantitative and qualitative data will be analysed separately and triangulated to produce deeper insights and robust results. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Research Ethics Comittee (CEIm) at IDIAP Jordi Gol (codeCEIm 21/051 P). Findings will be disseminated through publications and conferences, as well as presentations to healthcare professionals and stakeholders from healthcare organisations. TRIAL REGISTRATION NUMBER: NCT05026775.

Is epilepsy related to psychiatric disorders in people with intellectual disability? A systematic review.

The prevalence of psychiatric disorders in people with Intellectual Disability (ID) is statistically higher than in the general population. There is a lack of consensus on the role that epilepsy plays in psychiatric disorders in people with ID. We carried out a systematic review of articles published between 1960 and 2022, focusing on high-quality, case-control original research studies that only included adult populations. The primary outcome was the prevalence of psychiatric disorders in people with intellectual disability with and without epilepsy. Six articles were finally included. Results were varied; some reported a statistical increase, whereas others did not find any statistical difference. Due to the current controversy on the role of epilepsy in psychiatric disorders in people with ID and the small number of publications on the topic, we cannot affirm a relationship between epilepsy and psychiatric disorders in people with ID.

Effectiveness and cost-effectiveness of an intervention to improve Initial Medication Adherence to treatments for cardiovascular diseases and diabetes in primary care: study protocol for a pragmatic cluster randomised controlled trial and economic model (the IMA-cRCT study).

BACKGROUND: Between 2 and 43% of patients who receive a new prescription in PC do not initiate their treatments. Non-initiation is associated with poorer clinical outcomes, more sick leave and higher costs to the healthcare system. Existing evidence suggests that shared decision-making positively impacts medication initiation. The IMA-cRCT assesses the effectiveness of the IMA intervention in improving adherence and clinical parameters compared to usual care in patients with a new treatment for cardiovascular disease and diabetes prescribed in PC, and its cost-effectiveness, through a cRCT and economic modelling. METHODS: The IMA intervention is a shared decision-making intervention based on the Theoretical Model of Non-initiation. A cRCT will be conducted in 24 PC teams in Catalonia (Spain), randomly assigned to the intervention group (1:1), and community pharmacies in the catchment areas of the intervention PC teams. Healthcare professionals in the intervention group will apply the intervention to all patients who receive a new prescription for cardiovascular disease or diabetes treatment (no other prescription from the same pharmacological group in the previous 6 months). All the study variables will be collected from real-world databases for the 12 months before and after receiving a new prescription. Effectiveness analyses will assess impact on initiation, secondary adherence, cardiovascular risk, clinical parameters and cardiovascular events. Cost-effectiveness analyses will be conducted as part of the cRCT from a healthcare and societal perspective in terms of extra cost per cardiovascular risk reduction and improved adherence; all analyses will be clustered. Economic models will be built to assess the long-term cost-effectiveness of the IMA intervention, in terms of extra cost for gains in QALY and life expectancy, using clinical trial data and data from previous studies. DISCUSSION: The IMA-cRCT represents an innovative approach to the design and evaluation of behavioural interventions that use the principles of complex interventions, pragmatic trials and implementation research. This study will provide evidence on the IMA intervention and on a new methodology for developing and evaluating complex interventions. The results of the study will be disseminated among stakeholders to facilitate its transferability to clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05026775 . Registered 30th August 2021.

Influence of the COVID-19 Pandemic on Adherence to Orally Administered Antineoplastics.

Background: Several factors can influence adherence to orally administered antineoplastics, including fear or anxiety resulting from situations such as the COVID-19 pandemic. The aim of this study was to analyse the influence of these patients' experiences on adherence to orally administered antineoplastics. Methods: Cross-sectional study in four hospitals including >18 year old cancer patients receiving orally administered antineoplastics during the first half of 2021. Data were collected from medical records and through telephone interviews. Adherence was assessed through the prescription refill records and pill counts. Patients' fear resulting from the pandemic was assessed by means of a structured questionnaire using a 5-point Likert-type scale. Results: Our sample compr BARCELONAised 268 patients (54% men) with a mean age of 64 years (SD 12). More than 15% had experienced afraid and 5% had experienced a dangerous situation when attending hospital, 17% felt they had received less care, and 30% preferred telepharmacy. Adherence measured by pill count was 69.3% and 95.5% according to prescription refill records. Patients who had experienced fear or anxiety when attending hospital were less adherent (aOR 0.47, 95% CI 0.23−0.96, p = 0.039). Conclusion: The fear experienced by some patients has affected adherence to treatment.

[Pre-post evaluation of an intergenerational program to improve wellbeing in older adults and age stereotypes in primary and secondary students: CRENCO project]. / Evaluación pre-post de un programa intergeneracional para mejorar el bienestar en personas mayores y los estereotipos edadistas en alumnos de primaria y secundaria: proyecto CRENCO.

OBJECTIVE: The present study aims to evaluate the effectiveness of the CRENCO project which was carried out during the COVID-19 pandemic including intergenerational activities shared by students from primary and secondary education and users of two centers for older adults and a day hospital in Catalonia. The effectiveness was assessed in terms of well-being in older adults and on negative stereotypes about the elderly in primary and secondary students. METHODS: Three interventions were carried out in which 32 older persons (9 users of centers for older adults and 23 of a day hospital), 99 primary students and 56 secondary students participated. Participants answered a questionnaire before and after the interventions. Through multilevel linear models for repeated measures, changes in feelings of loneliness, social support, anxiety and depressive symptoms, self-reported health and health-related quality of life were evaluated in older people. In primary and secondary students, changes in age stereotypes were evaluated. RESULTS: Health-related quality of life and self-reported health improved statistically after the interventions in older persons. Users of the day hospital also reported an improvement in social support. Primary school students improved their age stereotypes; no statistically significant changes were detected in secondary students. CONCLUSION: The results of the present study contribute to underlining the importance of intergenerational programs such as the one proposed by CRENCO, capable of improving well-being and providing a more realistic vision of the older adults. Our results suggest that these programs should be implemented during childhood in order to prevent the proliferation of ageist stereotypes in later life stages.

Evaluación pre-post de un programa intergeneracional para mejorar el bienestar en personas mayores y los estereotipos edadistas en alumnos de primaria y secundaria: proyecto CRENCO / Pre-post evaluation of an intergenerational program to improve wellbeing in older adults and age stereotypes in primary and secondary students: CRENCO project

Objetivo: El presente estudio tiene como objetivo evaluar la efectividad del proyecto CRENCO, que se desarrolló durante la pandemia por COVID-19, incluyendo actividades intergeneracionales compartidas por alumnos de primaria y secundaria y personas mayores en Cataluña. Se evalúa su efecto en el bienestar de las personas mayores y en los estereotipos negativos sobre las personas mayores de los alumnos.Métodos: Se llevaron a cabo tres intervenciones en las que participaron 32 personas mayores (9 usuarios de centros para mayores y 23 de un hospital de día), 99 alumnos de primaria y 56 alumnos de secundaria. Los participantes fueron entrevistados antes y después de las intervenciones. A través de modelos lineales multinivel de efectos aleatorios para medidas repetidas, se evaluaron, en personas mayores, cambios en sentimientos de soledad, soporte social, sintomatología ansiosa y depresiva, salud autopercibida y calidad de vida relacionada con la salud. En alumnos de primaria y secundaria se evaluaron cambios en estereotipos edadistas.Resultados: Las personas mayores reportaron una mejor calidad de vida relacionada con la salud y una mejor salud autopercibida al finalizar las intervenciones. Los usuarios del hospital de día reportaron también una mejora en el soporte social. Los alumnos de primaria mejoraron sus estereotipos edadistas, lo cual no sucedió en estudiantes de secundaria.Conclusiones: Los resultados del presente estudio contribuyen a subrayar la importancia de programas intergeneracionales como el que plantea CRENCO, capaces de mejorar el bienestar y aportar una visión más realista de las personas mayores. Nuestros resultados sugieren que estos proyectos deben ser implantados durante la infancia con el objetivo de impedir la proliferación de los estereotipos edadistas en las posteriores etapas vitales. (AU)

Objective: The present study aims to evaluate the effectiveness of the CRENCO project which was carried out during the COVID-19 pandemic including intergenerational activities shared by students from primary and secondary education and users of two centers for older adults and a day hospital in Catalonia. The effectiveness was assessed in terms of well-being in older adults and on negative stereotypes about the elderly in primary and secondary students.Methods: Three interventions were carried out in which 32 older persons (9 users of centers for older adults and 23 of a day hospital), 99 primary students and 56 secondary students participated. Participants answered a questionnaire before and after the interventions. Through multilevel linear models for repeated measures, changes in feelings of loneliness, social support, anxiety and depressive symptoms, self-reported health and health-related quality of life were evaluated in older people. In primary and secondary students, changes in age stereotypes were evaluated.Results: Health-related quality of life and self-reported health improved statistically after the interventions in older persons. Users of the day hospital also reported an improvement in social support. Primary school students improved their age stereotypes; no statistically significant changes were detected in secondary students.Conclusion: The results of the present study contribute to underlining the importance of intergenerational programs such as the one proposed by CRENCO, capable of improving well-being and providing a more realistic vision of the older adults. Our results suggest that these programs should be implemented during childhood in order to prevent the proliferation of ageist stereotypes in later life stages. (AU)

Non-initiation of prescribed medication from a Spanish health professionals' perspective: A qualitative exploration based on Grounded Theory.

We explore, from the perspective of primary care health professionals, the motivations that lead patients to not initiate prescribed treatments, by developing a qualitative study in Spanish primary care. Six focus groups (N = 46) were conducted with general practitioners, nurse practitioners, social workers and community pharmacists and carried out in primary care (PC) of Barcelona Province, from April to July of 2018. The 46 participants were identified by three general practitioners and two pharmacists. In the interviews, the reasons for non-initiation of PC patients' medication were explored. Triangulated content analysis was performed. Patients' perspective, analysed in a previous study, and professionals' perspective agree on most of the factors that affect non-initiation. New factors were categorized into existent categories, confirming, and supplementing the model developed with patients. Health professionals identified some new factors which were not present in the patients' discourse, such as stigma related to the drug, hidden reasons for consultation, the role of nurses in prescription and support, the role of the pharmacy technician, illiteracy and lack of social support. The professionals confirm and expand on the Theoretical Model of Medication Non-Initiation. Primary care professionals should consider the factors described when prescribing a new medication. Knowledge contributed by the model should guide the design of interventions to improve initiation.

Pediatric Medication Noninitiation in Spain.

OBJECTIVES: To estimate medication noninitiation prevalence in the pediatric population and identify the explanatory factors underlying this behavior. METHODS: Observational study of patients (<18 years old) receiving at least 1 new prescription (28 pharmaceutical subgroups; July 2017 to June 2018) in Catalonia, Spain. A prescription was considered new when there was no prescription for the same pharmaceutical subgroup in the previous 6 months. Noninitiation occurred when a prescription was not filled within 1 month or 6 months (sensitivity analysis). Prevalence was estimated as the proportion of total prescriptions not initiated. To identify explanatory factors, a multivariable multilevel logistic regression model was used, and adjusted odds ratios were reported. RESULTS: Overall, 1 539 003 new prescriptions were issued to 715 895 children. The overall prevalence of 1-month noninitiation was 9.0% (ranging from 2.6% [oral antibiotics] to 21.5% [proton pump inhibitors]), and the prevalence of 6-month noninitiation was 8.5%. Noninitiation was higher in the youngest and oldest population groups, in children from families with a 0% copayment rate (vulnerable populations) and those with conditions from external causes. Out-of-pocket costs of drugs increased the odds of noninitiation. The odds of noninitiation were lower when the prescription was issued by a pediatrician (compared with a primary or secondary care clinician). CONCLUSIONS: The prevalence of noninitiation of medical treatments in pediatrics is high and varies according to patients' ages and medical groups. Results suggest that there are inequities in access to pharmacologic treatments in this population that must be taken into account by health care planners and providers.

Multiple health behaviour change primary care intervention for smoking cessation, physical activity and healthy diet in adults 45 to 75 years old (EIRA study): a hybrid effectiveness-implementation cluster randomised trial.

BACKGROUND: This study aimed to evaluate the effectiveness of a) a Multiple Health Behaviour Change (MHBC) intervention on reducing smoking, increasing physical activity and adherence to a Mediterranean dietary pattern in people aged 45-75 years compared to usual care; and b) an implementation strategy. METHODS: A cluster randomised effectiveness-implementation hybrid trial-type 2 with two parallel groups was conducted in 25 Spanish Primary Health Care (PHC) centres (3062 participants): 12 centres (1481 participants) were randomised to the intervention and 13 (1581 participants) to the control group (usual care). The intervention was based on the Transtheoretical Model and focused on all target behaviours using individual, group and community approaches. PHC professionals made it during routine care. The implementation strategy was based on the Consolidated Framework for Implementation Research (CFIR). Data were analysed using generalised linear mixed models, accounting for clustering. A mixed-methods data analysis was used to evaluate implementation outcomes (adoption, acceptability, appropriateness, feasibility and fidelity) and determinants of implementation success. RESULTS: 14.5% of participants in the intervention group and 8.9% in the usual care group showed a positive change in two or all the target behaviours. Intervention was more effective in promoting dietary behaviour change (31.9% vs 21.4%). The overall adoption rate by professionals was 48.7%. Early and final appropriateness were perceived by professionals as moderate. Early acceptability was high, whereas final acceptability was only moderate. Initial and final acceptability as perceived by the participants was high, and appropriateness moderate. Consent and recruitment rates were 82.0% and 65.5%, respectively, intervention uptake was 89.5% and completion rate 74.7%. The global value of the percentage of approaches with fidelity ≥50% was 16.7%. Eight CFIR constructs distinguished between high and low implementation, five corresponding to the Inner Setting domain. CONCLUSIONS: Compared to usual care, the EIRA intervention was more effective in promoting MHBC and dietary behaviour change. Implementation outcomes were satisfactory except for the fidelity to the planned intervention, which was low. The organisational and structural contexts of the centres proved to be significant determinants of implementation effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03136211 . Registered 2 May 2017, "retrospectively registered".

Cost-effectiveness analysis of a multiple health behaviour change intervention in people aged between 45 and 75 years: a cluster randomized controlled trial in primary care (EIRA study).

BACKGROUND: Multiple health behaviour change (MHBC) interventions that promote healthy lifestyles may be an efficient approach in the prevention or treatment of chronic diseases in primary care. This study aims to evaluate the cost-utility and cost-effectiveness of the health promotion EIRA intervention in terms of MHBC and cardiovascular reduction. METHODS: An economic evaluation alongside a 12-month cluster-randomised (1:1) controlled trial conducted between 2017 and 2018 in 25 primary healthcare centres from seven Spanish regions. The study took societal and healthcare provider perspectives. Patients included were between 45 and 75 years old and had any two of these three behaviours: smoking, insufficient physical activity or low adherence to Mediterranean dietary pattern. Intervention duration was 12 months and combined three action levels (individual, group and community). MHBC, defined as a change in at least two health risk behaviours, and cardiovascular risk (expressed in % points) were the outcomes used to calculate incremental cost-effectiveness ratios (ICER). Quality-adjusted life-years (QALYs) were estimated and used to calculate incremental cost-utility ratios (ICUR). Missing data was imputed and bootstrapping with 1000 replications was used to handle uncertainty in the modelling results. RESULTS: The study included 3062 participants. Intervention costs were €295 higher than usual care costs. Five per-cent additional patients in the intervention group did a MHBC compared to usual care patients. Differences in QALYS or cardiovascular risk between-group were close to 0 (- 0.01 and 0.04 respectively). The ICER was €5598 per extra health behaviour change in one patient and €6926 per one-point reduction in cardiovascular risk from a societal perspective. The cost-utility analysis showed that the intervention increased costs and has no effect, in terms of QALYs, compared to usual care from a societal perspective. Cost-utility planes showed high uncertainty surrounding the ICUR. Sensitivity analysis showed results in line with the main analysis. CONCLUSION: The efficiency of EIRA intervention cannot be fully established and its recommendation should be conditioned by results on medium-long term effects. TRIAL REGISTRATION: Clinicaltrials.gov NCT03136211 . Registered 02 May 2017 - Retrospectively registered.

Who Suffers From Pharmaceutical Poverty and What Are Their Needs? Evidence From a Spanish Region.

Background: Pharmaceutical poverty occurs when a patient cannot afford the cost of prescribed medication and/or medical products. Nonprofit organizations are covering the cost of medication to those patients in some contexts. The aim of the study was to describe the population of beneficiaries of the PB, a nongovernmental organization based on the primary healthcare system, which provides free-of-charge access to medicines and their utilization pattern of medicines and healthcare products. Methods: This was an observational study using PB beneficiary data collected between November 2017 and December 2018 in Catalonia. The Catalan Health Service provided information from the general population. A descriptive analysis of the beneficiaries' characteristics was conducted and compared to the general population. Results: The beneficiaries (N = 1,206) were mainly adults with a low level of education, unemployed, with functional disability, and with ≥1 child. Compared with the general population, the beneficiaries were older, had a lower level of education, showed a higher prevalence of functional disability, were less likely to be Spanish, and were more likely to be divorced and unemployed. The beneficiaries were polymedicated, and most were using medication related to the nervous (79%), musculoskeletal (68%), and cardiovascular system (56%) and alimentary tract and metabolism (68%). Almost 19% of beneficiaries used healthcare products. Female beneficiaries were older and more likely to be divorced or widowed, employed, and with children. Compared to men, women were more likely to use medicines for pain and mental disorders. The pediatric group used medications for severe, chronic conditions (heart diseases, autoimmune diseases, conduct disorders, and attention deficit hyperactivity disorder). Conclusion: Patients with severe, chronic, and disabling conditions are affected by pharmaceutical poverty. While the system of copayment remains unchanged, family physicians and pediatricians should explore economic barriers to treatment and direct their patients to resources that help to cover the cost of treatment.

Social network size, loneliness, physical functioning and depressive symptoms among older adults: Examining reciprocal associations in four waves of the Longitudinal Aging Study Amsterdam (LASA).

INTRODUCTION: Previous research indicates that social isolation, loneliness, physical dysfunction and depressive symptoms are interrelated factors, little is known about the potential pathways among them. The aim of the study is to analyse simultaneously reciprocal relationships that could exist between the four factors to clarify potential mediation effects. METHODS: Within a large representative sample of older people in the Longitudinal Aging Study Amsterdam (LASA), participants aged 75 and over were followed up over a period of 11 years (four waves). We tested cross-lagged and autoregressive longitudinal associations of social network size, loneliness, physical functioning and depressive symptoms using structural equation modelling (SEM). RESULTS: Several statistically significant cross-lagged associations were found: decreasing physical functioning (Coef. = -0.03; p < 0.05), as well as social network size (Coef. = -0.02; p < 0.05), predicted higher levels of loneliness, which predicted an increase in depressive symptoms (Coef. = 0.17; p < 0.05) and further reduction of social network (Coef. = -0.20; p < 0.05). Decreasing physical functioning also predicted an increase in depressive symptoms (Coef. = -0.08; p < 0.05). All autoregressive associations were statistically significant. CONCLUSION: Interventions focused on promoting social activities among older adults after negative life events, such as loss of social contacts or declining physical function, may alleviate feelings of loneliness and act as mental health protector.

Principles of pharmacoeconomic analysis: the case of pharmacist-led interventions.

In the past years, several factors such as evidence-based healthcare culture, quality-linked incentives, and patient-centered actions, associated with an important increase of financial constraints and pressures on healthcare budgets, resulted in a growing interest by policy-makers in enlarging pharmacists' roles in care. Numerous studies have demonstrated positive therapeutic outcomes associated with pharmaceutical services in a wide array of diseases. Yet, the evidence of the economic impact of the pharmacist in decreasing total health expenditures, unnecessary care, and societal costs relies on well-performed, reliable, and transparent economic evaluations, which are scarce. Pharmacoeconomics is a branch of health economics that usually focuses on balancing the costs and benefits of an intervention towards the use of limited resources, aiming at maximizing value to patients, healthcare payers and society through data driven decision making. These decisions can be guide by a health technology assessment (HTA) process that inform governmental players about medical, social, and economic implications of development, diffusion, and use of health technologies - including clinical pharmacy interventions. This paper aims to provide an overview of the important concepts in costing in healthcare, including studies classification according to the type of analysis method (e.g. budget-impact analysis, cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis), types of costs (e.g. direct, indirect and intangible costs) and outcomes (e.g. events prevented, quality adjusted life year - QALY, disability adjusted life year - DALY). Other key components of an economic evaluation such as the models' perspective, time horizon, modelling approaches (e.g. decision trees or simulation models as the Markov model) and sensitivity analysis are also briefly covered. Finally, we discuss the methodological issues for the identification, measurement and valuation of costs and benefits of pharmacy services, and suggest some recommendations for future studies, including the use of Value of Assessment Frameworks.

Principles of pharmacoeconomic analysis: the case of pharmacist-led interventions

In the past years, several factors such as evidence-based healthcare culture, quality-linked incentives, and patient-centered actions, associated with an important increase of financial constraints and pressures on healthcare budgets, resulted in a growing interest by policy-makers in enlarging pharmacists' roles in care. Numerous studies have demonstrated positive therapeutic outcomes associated with pharmaceutical services in a wide array of diseases. Yet, the evidence of the economic impact of the pharmacist in decreasing total health expenditures, unnecessary care, and societal costs relies on well-performed, reliable, and transparent economic evaluations, which are scarce. Pharmacoeconomics is a branch of health economics that usually focuses on balancing the costs and benefits of an intervention towards the use of limited resources, aiming at maximizing value to patients, healthcare payers and society through data driven decision making. These decisions can be guide by a health technology assessment (HTA) process that inform governmental players about medical, social, and economic implications of development, diffusion, and use of health technologies - including clinical pharmacy interventions. This paper aims to provide an overview of the important concepts in costing in healthcare, including studies classification according to the type of analysis method (e.g. budget-impact analysis, cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis), types of costs (e.g. direct, indirect and intangible costs) and outcomes (e.g. events prevented, quality adjusted life year - QALY, disability adjusted life year - DALY). Other key components of an economic evaluation such as the models' perspective, time horizon, modelling approaches (e.g. decision trees or simulation models as the Markov model) and sensitivity analysis are also briefly covered. Finally, we discuss the methodological issues for the identification, measurement and valuation of costs and benefits of pharmacy services, and suggest some recommendations for future studies, including the use of Value of Assessment Frameworks

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Use of Mental Health Services for Patients Diagnosed with Major Depressive Disorders in Primary Care.

Major depressive disorder (MDD) is one of the most disabling diseases worldwide, generating high use of health services. Previous studies have shown that Mental Health Services (MHS) use is associated with patient and Family Physician (FP) factors. The aim of this study was to investigate MHS use in a naturalistic sample of MDD outpatients and the factors influencing use of services in specialized psychiatric care, to know the natural mental healthcare pathway. Non-randomized clinical trial including newly depressed Primary Care (PC) patients (n = 263) with a 12-month follow-up (from 2013 to 2015). Patient sociodemographic variables were assessed along with clinical variables (mental disorder diagnosis, severity of depression or anxiety, quality of life, disability, beliefs about illness and medication). FP (n = 53) variables were also evaluated. A multilevel logistic regression analysis was performed to assess factors associated with public or private MHS use. Subjects were clustered by FP. Having previously used MHS was associated with the use of MHS. The use of public MHS was associated with worse perception of quality of life. No other sociodemographic, clinical, nor FP variables were associated with the use of MHS. Patient self-perception is a factor that influences the use of services, in addition to having used them before. This is in line with Value-Based Healthcare, which propose to put the focus on the patient, who is the one who must define which health outcomes are relevant to him.