Patient Satisfaction and Willingness to Continue with Telemental Health Care During and After the Early Period of SARS-CoV-2 Pandemic: A User Survey.

Objective: The SARS-CoV-2 pandemic and related lockdown periods generated an increase in the use of virtual care for mental health (MH). This study aimed to assess patient satisfaction with Telemental Health services (TMH) during first lockdown and factors related to their willingness to continue using this service. Methods: We conducted a cross-sectional survey of 364 MH outpatients from 9 centers in the Barcelona region (Spain), who received TMH between April 20 and May 22, 2020. We assessed sociodemographic and clinical characteristics, prior experience, and familiarity with technologies and satisfaction with TMH. Willingness to receive TMH after the lockdown was measured separately for telephone and videoconferencing. We performed descriptive statistics and bivariate and multivariate regression models to predict TMH willingness. Results: From 450 patients contacted, 364 were interviewed. Satisfaction with TMH was high (mean 9.24, standard deviation 0.07); 2.47% preferred only TMH visits after lockdown, 23.08% preferred mostly TMH visits, 50.82% accepted some TMH visits, and 23.63% would prefer in-person consultations. Female patients and those having received TMH during lockdown showed higher odds of willingness to receive TMH in the future, while patients unfamiliar with technologies showed lower odds. Concerning TMH through telephone, willingness was more likely in patients living with more persons. Videoconferencing willingness was more likely for people living with depression. Conclusions: TMH was well accepted during the first lockdown and patients were willing to maintain it after lockdown. Low familiarity with new technologies is an important barrier to TMH willingness, which needs to be addressed for appropriate implementation going forward.

Design of a Remote Multiparametric Tool to Assess Mental Well-Being and Distress in Young People (mHealth Methods in Mental Health Research Project): Protocol for an Observational Study.

BACKGROUND: Mental health conditions have become a substantial cause of disability worldwide, resulting in economic burden and strain on the public health system. Incorporating cognitive and physiological biomarkers using noninvasive sensors combined with self-reported questionnaires can provide a more accurate characterization of the individual's well-being. Biomarkers such as heart rate variability or those extracted from the electrodermal activity signal are commonly considered as indices of autonomic nervous system functioning, providing objective indicators of stress response. A model combining a set of these biomarkers can constitute a comprehensive tool to remotely assess mental well-being and distress. OBJECTIVE: This study aims to design and validate a remote multiparametric tool, including physiological and cognitive variables, to objectively assess mental well-being and distress. METHODS: This ongoing observational study pursues to enroll 60 young participants (aged 18-34 years) in 3 groups, including participants with high mental well-being, participants with mild to moderate psychological distress, and participants diagnosed with depression or anxiety disorder. The inclusion and exclusion criteria are being evaluated through a web-based questionnaire, and for those with a mental health condition, the criteria are identified by psychologists. The assessment consists of collecting mental health self-reported measures and physiological data during a baseline state, the Stroop Color and Word Test as a stress-inducing stage, and a final recovery period. Several variables related to heart rate variability, pulse arrival time, breathing, electrodermal activity, and peripheral temperature are collected using medical and wearable devices. A second assessment is carried out after 1 month. The assessment tool will be developed using self-reported questionnaires assessing well-being (short version of Warwick-Edinburgh Mental Well-being Scale), anxiety (Generalized Anxiety Disorder-7), and depression (Patient Health Questionnaire-9) as the reference. We will perform correlation and principal component analysis to reduce the number of variables, followed by the calculation of multiple regression models. Test-retest reliability, known-group validity, and predictive validity will be assessed. RESULTS: Participant recruitment is being carried out on a university campus and in mental health services. Recruitment commenced in October 2022 and is expected to be completed by June 2024. As of July 2023, we have recruited 41 participants. Most participants correspond to the group with mild to moderate psychological distress (n=20, 49%), followed by the high mental well-being group (n=13, 32%) and those diagnosed with a mental health condition (n=8, 20%). Data preprocessing is currently ongoing, and publication of the first results is expected by September 2024. CONCLUSIONS: This study will establish an initial framework for a comprehensive mental health assessment tool, taking measurements from sophisticated devices, with the goal of progressing toward a remotely accessible and objectively measured approach that maintains an acceptable level of accuracy in clinical practice and epidemiological studies. TRIAL REGISTRATION: OSF Registries N3GCH; https://doi.org/10.17605/OSF.IO/N3GCH. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51298.

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.

Reconsidering the Use of Population Health Surveys for Monitoring of Mental Health.

Monitoring of the mental health status of the population and assessment of its determinants are 2 of the most relevant pillars of public mental health, and data from population health surveys could be instrumental to support them. Although these surveys could be an important and suitable resource for these purposes, due to different limitations and challenges, they are often relegated to the background behind other data sources, such as electronic health records. These limitations and challenges include those related to measurement properties and cross-cultural validity of the tools used for the assessment of mental disorders, their degree of representativeness, and possible difficulties in the linkage with other data sources. Successfully addressing these limitations could significantly increase the potential of health surveys in the monitoring of mental disorders and ultimately maximize the impact of the relevant policies to reduce their burden at the population level. The widespread use of data from population health surveys, ideally linked to electronic health records data, would enhance the quality of the information available for research, public mental health decision-making, and ultimately addressing the growing burden of mental disorders.

Prevalence and variability of depressive symptoms in Europe: update using representative data from the second and third waves of the European Health Interview Survey (EHIS-2 and EHIS-3).

BACKGROUND: Assessing the prevalence of clinically relevant depressive symptoms and their possible variation by country and over time could be a valuable resource to inform the development of public health policies and preventive resources to reduce mental health burden. We aimed to assess cross-national differences in the point prevalence of clinically relevant depressive symptoms in Europe in 2018-20, and to evaluate point prevalence differences between countries and over time between 2013-15 and 2018-20. METHODS: In this population-based study, data from participants in the second and third waves of the European Health Interview Survey (EHIS-2 from 2013 to 2015 and EHIS-3 from 2018 to 2020) from 30 European countries were used (n=542 580). From the total sample, 283 692 participants belonging to EHIS-3 were included in the study (52·4% women and 47·5% men). The non-response in EHIS-3 ranged by country, from 12% to 78%. Point prevalence of clinically relevant depressive symptoms was evaluated using a cutoff score of 10 or more for the 8-item version of the Patient Health Questionnaire. Crude prevalence ratios and adjusted prevalence ratios (aPRs) were obtained to assess differences in the prevalence between countries and over time within countries. FINDINGS: The point prevalence of clinically relevant depressive symptoms in Europe in 2018-20 was 6·54% (95% CI 6·34-6·73), ranging across countries from 1·85% (1·53-2·17) in Greece to 10·72% (10·04-11·40) in Sweden. Compared with the other European countries, those with the lowest aPRs were Greece, Serbia, and Cyprus and those with the highest aPRs were Belgium, Slovenia, and Croatia. A small but significant increase in the prevalence between EHIS-2 and EHIS-3 was observed (aPR 1·11 [1·07-1·14]). A wide variability over time in the point prevalence within countries was observed, ranging from an aPR of 0·63 (0·54-0·74) in Hungary to 1·88 (1·53-2·31) in Slovenia. INTERPRETATION: This study, based on large and representative datasets and a valid and reliable screening tool for the assessment of depression, indicates that the point prevalence of clinically relevant depressive symptoms in Europe from 2013 to 2020 remains relatively stable, with wide variability between countries. These findings could be considered a baseline for monitoring the prevalence of clinically relevant depressive symptoms in Europe, and could inform policy for the development of preventive strategies for depression both at a country and European level. FUNDING: Center for Biomedical Research in Epidemiology and Public Health Network and AGAUR.

Consensus on post COVID in the Spanish national health system: Results of the CIBERPOSTCOVID eDelphi study.

BACKGROUND: In 2021, the Spanish Ministry of Health launched the CIBERPOSTCOVID project to establish what post COVID was. The present study reports the level of agreement among stakeholders on post COVID and its clinical and diagnostic characteristics in the Spanish health system. METHODS: The agreement on post COVID among clinicians, public health managers, researchers and patients' representatives was explored in a real-time, asynchronous online Delphi. In a two-wave consensus, respondents rated from 1 (total disagreement) to 6 (total agreement) 67 statements related to terminology, duration, etiology, symptoms, impact on quality of life, severity, elements to facilitate diagnosis, applicability in the pediatric population, and risk factors. Consensus was reached when 70 % of ratings for a statement were 5 or 6, with an interquartile range equal or less than 1. FINDINGS: A total of 333 professionals and patients participated in this eDelphi study. There was agreement that post COVID was "a set of multi-organic symptoms that persist or fluctuate after acute COVID-19 infection and are not attributable to other causes" with a minimum duration of 3 months. The highest levels of agreement were found in the most frequent symptoms and its impacts on everyday activities. Aspects related to the diagnostic process and the measurement of its severity reached a lower level of consensus. There was agreement on the need to rule out previous health problems and assess severity using validated functional scales. However, no agreement was reached on the risk factors or specific features in the pediatric population. INTERPRETATION: This policy-based consensus study has allowed the characterization of post COVID generating collective intelligence and has contributed to an operational definition applicable in clinical practice, health services management and useful for research purposes in Spain and abroad. Agreements are consistent with existing evidence and reference institutions at European and international level.

Reliability and cross-country equivalence of the 8-item version of the Patient Health Questionnaire (PHQ-8) for the assessment of depression: results from 27 countries in Europe.

Background: The 8-item version of the Patient Health Questionnaire (PHQ-8) is one of the self-reported questionnaires most frequently used worldwide for the screening and severity assessment of depression. However, in some European countries its reliability is unknown, and it is unclear whether its psychometric properties vary between European countries. Therefore, the aim of this study was to assess the internal structure, reliability and cross-country equivalence of the PHQ-8 in Europe. Methods: All participants from the 27 countries included in the second wave of the European Health Interview Survey (EHIS-2) between 2014 and 2015 with complete information on the PHQ-8 were included (n = 258,888). The internal structure of the PHQ-8 was assessed using confirmatory factor analyses (CFA) for categorical items. Additionally, the reliability of the questionnaire was assessed based on the internal consistency, Item Response Theory information functions, and item-discrimination (using Graded Response Models), and the cross-country equivalence based on multi-group CFA. Findings: The PHQ-8 shows high internal consistency for all countries. The countries in which the PHQ-8 was more reliable were Romania, Bulgaria and Cyprus and less reliable were Iceland, Norway and Austria. The PHQ-8 item with highest discrimination was item 2 (feeling down, depressed, or hopeless) in 24 of the 27 countries. Measurement invariance between countries in Europe was observed from multigroup CFA at the configural, metric and scalar levels. Interpretation: The results from our study, likely the largest study to the date assessing the internal structure, reliability and cross-country comparability of a self-reported mental health assessment measure, shows that the PHQ-8 has an adequate reliability and cross-country equivalence across the 27 European countries included. These results highlight the suitability of the comparisons of the PHQ-8 scores in Europe. They could be helpful to improve the screening and severity assessment of depressive symptoms at the European level. Funding: This work was partially funded by CIBER Epidemiology and Public Health (CIBERESP) as part of the Intramural call of 2021 (ESP21PI05).

Modeling the potential efficiency of a blood biomarker-based tool to guide pre-hospital thrombolytic therapy in stroke patients.

OBJECTIVES: Stroke treatment with intravenous tissue-type plasminogen activator (tPA) is effective and efficient, but as its benefits are highly time dependent, it is essential to treat the patient promptly after symptom onset. This study evaluates the cost-effectiveness of a blood biomarker test to differentiate ischemic and hemorrhagic stroke to guide pre-hospital treatment with tPA in patients with suspected stroke, compared with standard hospital management. The standard care for patients suffering stroke consists mainly in diagnosis, treatment, hospitalization and monitoring. METHODS: A Markov model was built with four health states according to the modified Rankin scale, in adult patients with suspected moderate to severe stroke (NIHSS 4-22) within 4.5 hours after symptom onset. A Spanish Health System perspective was used. The time horizon was 15 years. Quality-adjusted life-years (QALYs) and life-years gained (LYGs) were used as a measure of effectiveness. Short- and long-term direct health costs were included. Costs were expressed in Euros (2022). A discount rate of 3% was used. Probabilistic sensitivity analysis and several one-way sensitivity analyses were conducted. RESULTS: The use of a blood-test biomarker compared with standard care was associated with more QALYs (4.87 vs. 4.77), more LYGs (7.18 vs. 7.07), and greater costs (12,807€ vs. 12,713€). The ICER was 881€/QALY. Probabilistic sensitivity analysis showed that the biomarker test was cost-effective in 82% of iterations using a threshold of 24,000€/QALY. CONCLUSIONS: The use of a blood biomarker test to guide pre-hospital thrombolysis is cost-effective compared with standard hospital care in patients with ischemic stroke.

Spirituality, Religiosity and Mental Health: A Clinical-care Approach.

No abstract present.

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.

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.

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.

Assessment of a Primary Support Program: family physicians and mental health professionals' perspective.

BACKGROUND: Mental health (MH) disorders are increasingly prevalent in primary care (PC) and this has generated, in recent years, the development of strategies based on the collaborative model and the stepped care model. The Primary Support Program (PSP) was implemented in the community of Catalonia (Spain) during 2006 to improve, from the first level of care, treatment of the population with mild-moderate complexity MH problems along with identification and referral of severe cases to specialized care. The aim of the present study was to identify the strengths and limitations of the PSP from the perspective of health professionals involved in the programme. METHODS: An explanatory qualitative study based on Grounded Theory. We conducted group semistructured interviews with 37 family physicians and 34 MH professionals. A constant comparative method of analysis was performed. RESULTS: Operation of the PSP is influenced by internal factors, such as the programme framework, MH liaison, management of service supply and demand, and the professional team involved. Additionally, external factors which had an impact were related to the patient, the professionals, the Health System, and community resources. CONCLUSIONS: The operation of the PSP could benefit from a review of the programme framework and optimization of MH liaison. Improvements are also proposed for MH training in PC, intraprofessional coordination, use of community resources, and creation of efficient continuous assessment systems.

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.

Identification of the most vulnerable populations in the psychosocial sphere: a cross-sectional study conducted in Catalonia during the strict lockdown imposed against the COVID-19 pandemic.

DESIGN AND OBJECTIVES: A cross-sectional study to evaluate the impact of COVID-19 on the psychosocial sphere in both the general population and healthcare workers (HCWs). METHODS: The study was conducted in Catalonia (Spain) during the first wave of the COVID-19 pandemic when strict lockdown was in force. The study population included all people aged over 16 years who consented to participate in the study and completed the survey, in this case a 74-question questionnaire shared via social media using snowball sampling. A total of 56 656 completed survey questionnaires were obtained between 3 and 19 April 2020.The primary and secondary outcome measures included descriptive statistics for the non-psychological questions and the psychological impact of the pandemic, such as depression, anxiety, stress and post-traumatic stress disorder question scores. RESULTS: A n early and markedly negative impact on family finances, fear of working with COVID-19 patients and ethical issues related to COVID-19 care among HCWs was observed. A total of seven target groups at higher risk of impaired mental health and which may therefore benefit from an intervention were identified, namely women, subjects aged less than 42 years, people with a care burden, socioeconomically deprived groups, people with unskilled or unqualified jobs, patients with COVID-19 and HCWs working with patients with COVID-19. CONCLUSIONS: Active implementation of specific strategies to increase resilience and to prepare an adequate organisational response should be encouraged for the seven groups identified as high risk and susceptible to benefit from an intervention. TRIAL REGISTRATION NUMBER: NCT04378452.

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.