Role of personal aptitudes as determinants of incident morbidity, lifestyles, quality of life, use of the health services and mortality (DESVELA cohort): qualitative study protocol for a prospective cohort study in a hybrid analysis.

Introduction: Maintaining or acquiring healthier health-oriented behaviours and promoting physical and mental health amongst the Spanish population is a significant challenge for Primary Health Care. Although the role of personal aptitudes (characteristics of each individual) in influencing health behaviours is not yet clear, these factors, in conjunction with social determinants such as gender and social class, can create axes of social inequity that affect individuals' opportunities to engage in health-oriented behaviours. Additionally, lack of access to health-related resources and opportunities can further exacerbate the issue for individuals with healthy personal aptitudes. Therefore, it is crucial to investigate the relationship between personal aptitudes and health behaviours, as well as their impact on health equity. Objectives: This paper outlines the development, design and rationale of a descriptive qualitative study that explores in a novel way the views and experiences on the relationship between personal aptitudes (activation, health literacy and personality traits) and their perception of health, health-oriented behaviours, quality of life and current health status. Method and analysis: This qualitative research is carried out from a phenomenological perspective. Participants will be between 35 and 74 years of age, will be recruited in Primary Health Care Centres throughout Spain from a more extensive study called DESVELA Cohort. Theoretical sampling will be carried out. Data will be collected through video and audio recording of 16 focus groups in total, which are planned to be held in 8 different Autonomous Communities, and finally transcribed for a triangulated thematic analysis supported by the Atlas-ti program. Discussion: We consider it essential to understand the interaction between health-related behaviours as predictors of lifestyles in the population, so this study will delve into a subset of issues related to personality traits, activation and health literacy.Clinical trial registration: ClinicalTrials.gov, identifier NCT04386135.

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.

Effectiveness of a multiple health-behaviour-change intervention in increasing adherence to the Mediterranean Diet in adults (EIRA study): a randomized controlled hybrid trial.

BACKGROUND: The present study describes the effectiveness of a complex intervention that addresses multiple lifestyles to promote healthy behaviours in increasing adherence to the Mediterranean diet (MD).  METHODS: Cluster-randomised, hybrid clinical trial controlled with two parallel groups. The study was carried out in 26 primary Spanish healthcare centres. People aged 45-75 years who presented at least two of the following criteria were included: smoker, low adherence to the MD or insufficient level of physical activity. The intervention group (IG) had three different levels of action: individual, group, and community, with the aim of acting on the behaviours related to smoking, diet and physical activity at the same time. The individual intervention included personalised recommendations and agreements on the objectives to attain. Group sessions were adapted to the context of each healthcare centre. The community intervention was focused on the social prescription of resources and activities performed in the environment of the community of each healthcare centre. Control group (CG) received brief advice given in the usual visits to the doctor's office. The primary outcome was the change, after 12 months, in the number of participants in each group with good adherence to the MD pattern. Secondary outcomes included the change in the total score of the MD adherence score (MEDAS) and the change in some cardiovascular risk factors. RESULTS: Three thousand sixty-two participants were included (IG = 1,481, CG = 1,581). Low adherence to the MD was present in 1,384 (93.5%) participants, of whom 1,233 initiated the intervention and conducted at least one individual visit with a healthcare professional. A greater increase (13.7%; 95% CI, 9.9-17.5; p < 0.001) was obtained by IG in the number of participants who reached 9 points or more (good adherence) in the MEDAS at the final visit. Moreover, the effect attributable to the intervention obtained a greater increase (0.50 points; 95% CI, 0.35 to 0.66; p < 0.001) in IG. CONCLUSIONS: A complex intervention modelled and carried out by primary healthcare professionals, within a real clinical healthcare context, achieved a global increase in the adherence to the MD compared to the brief advice. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03136211. Retrospectively registered on 02/05/2017 https://clinicaltrials.gov/ct2/show/NCT03136211.

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.

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.

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.

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.

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".

Effectiveness of a Multicomponent Intervention in Primary Care That Addresses Patients with Diabetes Mellitus with Two or More Unhealthy Habits, Such as Diet, Physical Activity or Smoking: Multicenter Randomized Cluster Trial (EIRA Study).

Introduction: We evaluated the effectiveness of an individual, group and community intervention to improve the glycemic control of patients with diabetes mellitus aged 45-75 years with two or three unhealthy life habits. As secondary endpoints, we evaluated the inverventions' effectiveness on adhering to Mediterranean diet, physical activity, sedentary lifestyle, smoking and quality of life. Method: A randomized clinical cluster (health centers) trial with two parallel groups in Spain from January 2016 to December 2019 was used. Patients with diabetes mellitus aged 45-75 years with two unhealthy life habits or more (smoking, not adhering to Mediterranean diet or little physical activity) participated. Centers were randomly assigned. The sample size was estimated to be 420 people for the main outcome variable. Educational intervention was done to improve adherence to Mediterranean diet, physical activity and smoking cessation by individual, group and community interventions for 12 months. Controls received the usual health care. The outcome variables were: HbA1c (main), the Mediterranean diet adherence score (MEDAS), the international diet quality index (DQI-I), the international physical activity questionnaire (IPAQ), sedentary lifestyle, smoking ≥1 cigarette/day and the EuroQuol questionnaire (EVA-EuroQol5D5L). Results: In total, 13 control centers (n = 356) and 12 intervention centers (n = 338) were included with similar baseline conditions. An analysis for intention-to-treat was done by applying multilevel mixed models fitted by basal values and the health center: the HbA1c adjusted mean difference = -0.09 (95% CI: -0.29-0.10), the DQI-I adjusted mean difference = 0.25 (95% CI: -0.32-0.82), the MEDAS adjusted mean difference = 0.45 (95% CI: 0.01-0.89), moderate/high physical activity OR = 1.09 (95% CI: 0.64-1.86), not living a sedentary lifestyle OR = 0.97 (95% CI: 0.55-1.73), no smoking OR = 0.61 (95% CI: 0.54-1.06), EVA adjusted mean difference = -1.26 (95% CI: -4.98-2.45). Conclusions: No statistically significant changes were found for either glycemic control or physical activity, sedentary lifestyle, smoking and quality of life. The multicomponent individual, group and community interventions only showed a statistically significant improvement in adhering to Mediterranean diet. Such innovative interventions need further research to demonstrate their effectiveness in patients with poor glycemic control.

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.

Farmacia comunitaria, adherencia al tratamiento y COVID-19 / Community pharmacy, treatment adherence and COVID-19

La falta de adherencia es un problema mundial cada vez mayor y es la responsable de que los resultados esperados en salud se alejen de la realidad, aumentando el gasto sanitario. Comprender por qué un paciente no es adherente requiere identificar los factores implicados en su caso concreto y personalizar las estrategias a seguir. Para abordar la no adherencia desde la farmacia comunitaria tenemos el protocolo de la guía ADHe+ de dispensación y uso racional del medicamento, que clasifica a los pacientes no adherentes en tres perfiles (confundido, desconfiado y banalizador), facilitando la tarea de evaluación de sus creencias hacia un medicamento en concreto y en un momento determinado. Siguiendo el protocolo propuesto por la guía, el farmacéutico puede detectar la no adherencia en los medicamentos que el paciente recoge y en los que no e indagar en las causas. Pero el momento actual que estamos viviendo de pandemia por COVID-19 está cambiando el paradigma de la cronicidad. El miedo al contagio, la ralentización de los procesos asistenciales por las nuevas medidas de higiene, la telemedicina, el confinamiento y el desconocimiento de la nueva situación por parte de pacientes y sanitarios puede afectar mucho a la adherencia terapéutica

Non-adherence to treatment is becoming more and more of a global issue and is responsible for the fact that expected health results are getting further away from reality and increasing spending on healthcare. To understand why a patient is not adhering to treatment it is necessary to identify the factors involved in his or her specific case and personalize the strategies to be followed. In order to approach non-adherence to treatment from the community pharmacy perspective, we use the protocol from the ADHe+ guide on the dispensing and rational use of the drug, which classifies non-adhering patients into three profiles (confused, wary and trivializing), facilitating the task of assessing their beliefs with regards to a certain medicine and at a given time. Following the protocol suggested by the guide, pharmacists can detect non-adherence to the medicines the patient collects and does not collect and look into the causes. However, the current times of pandemic that we are experiencing-caused by COVID-19-are changing the pattern of chronicity. Fear of infection, the slowing down of care processes due to the new hygiene measures, telemedicine, quarantine, and the lack of awareness about the new situation by both the patients and healthcare professionals may have a great impact on therapeutic adherence

Initiation and Single Dispensing in Cardiovascular and Insulin Medications: Prevalence and Explanatory Factors.

BACKGROUND: Adherence problems have negative effects on health, but there is little information on the magnitude of non-initiation and single dispensing. OBJECTIVE: The aim of this study was to estimate the prevalence of non-initiation and single dispensation and identify associated predictive factors for the main treatments prescribed in Primary Care (PC) for cardiovascular disease (CVD) and diabetes. METHODS: Cohort study with real-world data. Patients who received a first prescription (2013-2014) for insulins, platelet aggregation inhibitors, angiotensin-converting enzyme inhibitors (ACEI) or statins in Catalan PC were included. The prevalence of non-initiation and single dispensation was calculated. Factors that explained these behaviours were explored. RESULTS: At three months, between 5.7% (ACEI) and 9.1% (antiplatelets) of patients did not initiate their treatment and between 10.6% (statins) and 18.4% (ACEI) filled a single prescription. Body mass index, previous CVD, place of origin and having a substitute prescriber, among others, influenced the risk of non-initiation and single dispensation. CONCLUSIONS: The prevalence of non-initiation and single dispensation of CVD medications and insulin prescribed in PC in is high. Patient and health-system factors, such as place of origin and type of prescriber, should be taken into consideration when prescribing new medications for CVD and diabetes.

Diagnostic accuracy and treatment approach to depression in primary care: predictive factors.

Objective: The study assessed the predictive factors of diagnostic accuracy and treatment approach (antidepressants versus active monitoring) for depression in primary care. Methods: This is a cross-sectional study that uses information from a naturalistic prospective controlled trial performed in Barcelona (Spain) enrolling newly diagnosed patients with mild to moderate depression by GPs. Treatment approach was based on clinical judgement. Diagnosis was later assessed according to DSM-IV criteria using Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) interview by an external researcher. Patients (sociodemographic, psychiatric diagnosis, severity of depression and anxiety, health-related quality of life, disability, beliefs about medication and illness and comorbidities) and GP factors associated with diagnostic accuracy and treatment approach were assessed using multilevel logistic regression. Variables with missing data were imputed through multiple imputations. Results: Two hundred sixty-three patients were recruited by 53 GPs. Mean age was 51 years (SD = 15). Thirty percent met DSM-IV criteria for major depression. Mean depression symptomatology was moderate-severe. Using multivariate analyses, patients' beliefs about medicines were the only variable associated with the antidepressant approach. Specialization in general medicine and being a resident tutor were associated with a more accurate diagnosis. Conclusions: Clinical depression diagnosis by GPs was not always associated with a formal diagnosis through a SCID-I. GPs' training background was central to an adequate depression diagnosis. Patients' beliefs in medication were the only factor associated with treatment approach. More resources should be allocated to improving the diagnosis of depression.

Effect of copayment policies on initial medication non-adherence according to income: a population-based study.

OBJECTIVE: Copayment policies aim to reduce the burden of medication expenditure but may affect adherence and generate inequities in access to healthcare. The objective was to evaluate the impact of two copayment measures on initial medication non-adherence (IMNA) in several medication groups and by income level. DESIGN: A population-based study was conducted using real-world evidence. SETTING: Primary care in Catalonia (Spain) where two separate copayment measures (fixed copayment and coinsurance) were introduced between 2011 and 2013. PARTICIPANT: Every patient with a new prescription issued between 2011 and 2014 (3 million patients and 10 million prescriptions). OUTCOMES: IMNA was estimated throughout dispensing and invoicing information. Changes in IMNA prevalence after the introduction of copayment policies (immediate level change and trend changes) were estimated through segmented logistic regression. The regression models were stratified by economic status and medication groups. RESULTS: Before changes to copayment policies, IMNA prevalence remained stable. The introduction of a fixed copayment was followed by a statistically significant increase in IMNA in poor population, low/middle-income pensioners and low-income non-pensioners (OR from 1.047 to 1.370). In high-income populations, there was a large statistically non-significant increase. IMNA decreased in the low-income population after suspension of the fixed copayment and the introduction of a coinsurance policy that granted this population free access to medications (OR=0.676). Penicillins were least affected while analgesics were affected to the greatest extent. IMNA to medications for chronic conditions increased in low/middle-income pensioners. CONCLUSION: Even nominal charge fixed copayment may generate inequities in access to health services. An anticipation effect and expenses associated with IMNA may have generated short-term costs. A reduction in copayment can protect from non-adherence and have positive, long-term effects. Copayment scenarios could have considerable long-term consequences for health and costs due to increased IMNA in medication for chronic physical conditions.

Impact of initial medication non-adherence to SSRIs on medical visits and sick leaves.

BACKGROUND: Initial medication non-adherence (IMNA) to antidepressants, which are commonly used to treat depression in primary care (PC), is around 6-12%. Although it is well known that post-initial non-adherence to antidepressants increases the cost of depression, the impact of IMNA on cost is unknown. The aim of this study is to assess the impact of IMNA to Selective Serotonin Reuptake Inhibitors (SSRI) on medical visits and sick leave in patients with depression treated in PC in Catalonia (Spain). METHODS: This was a four-year retrospective register-based study (2011-2014). All PC patients of working age who received a new SSRI prescription and had a diagnosis of depression were included (N = 79,642). Treatment initiation, number of visits and days on sick leave were gathered from the database. We assessed the impact of IMNA on costs with ordered logistic regressions. RESULTS: The 3-year incidence of IMNA was 15%. Initially non-adherent patients made a lesser number of GP visits (OR = 0.82; 95% CI = 0.79-0.84) but had more days on sick leave (OR = 1.25; 95% CI = 1.20-1.31). There were no differences in the number of specialist visits (OR = 1.04; 95% CI = 0.99-1.08). LIMITATIONS: Differences between adherent and non-adherent patients could be explained by non-observed variables. GP recognition and documentation of depression might be inaccurate. Costs of unpaid work and use of hospital services were not considered. CONCLUSIONS: Although IMNA decreases the use of medical PC services, it increases the number of days on sick leave. This could also indicate worse health status. These consequences are currently overlooked when considering post-initial medication non-adherence.

Impact of initial medication non-adherence on use of healthcare services and sick leave: a longitudinal study in a large primary care cohort in Spain.

BACKGROUND: Initial medication non-adherence is highly prevalent in primary care but no previous studies have evaluated its impact on the use of healthcare services and/or days on sick leave. AIM: To estimate the impact of initial medication non-adherence on the use of healthcare services, days of sick leave, and costs overall and in specific medication groups. DESIGN AND SETTING: A 3-year longitudinal register-based study of all primary care patients (a cohort of 1.7 million) who were prescribed a new medication in Catalonia (Spain) in 2012. METHOD: Thirteen of the most prescribed and/or costly medication subgroups were considered. All medication and medication subgroups (chronic, analgesics, and penicillin) were analysed. The number of healthcare services used and days on sick leave were considered. Multilevel multivariate linear regression was used. Three levels were included: patient, GP, and primary care centre. RESULTS: Initially adherent patients made more use of medicines and some healthcare services than non-adherent and partially adherent patients. They had lower productivity losses, producing a net economic return, especially when drugs for acute diseases (such as penicillins) were considered. Initial medication non-adherence resulted in a higher economic burden to the system in the short term. CONCLUSION: Initial medication non-adherence seems to have a short-term impact on productivity losses and costs. The clinical consequences and long-term economic consequences of initial medication non-adherence need to be assessed. Interventions to promote initial medication adherence in primary care may reduce costs and improve health outcomes.

Initial medication non-adherence: prevalence and predictive factors in a cohort of 1.6 million primary care patients.

AIMS: Adherence to medicines is vital in treating diseases. Initial medication non-adherence (IMNA) - defined as not obtaining a medication the first time it is prescribed - has been poorly explored. Previous studies show IMNA rates between 6 and 28% in primary care (PC). The aims of this study were to determine prevalence and predictive factors of IMNA in the most prescribed and expensive pharmacotherapeutic groups in the Catalan health system. METHODS: This is a retrospective, register-based cohort study which linked the Catalan PC System (Spain) prescription and invoicing databases. Medication was considered non-initiated when it was not collected from the pharmacy by the end of the month following the one in which it was prescribed. IMNA prevalence was calculated using July 2013-June 2014 prescription data. Predictive factors related to patients, general practitioners and PC centres were identified through multilevel logistic regression analyses. Missing data were attributed using simple imputation. RESULTS: Some 1.6 million patients with 2.9 million prescriptions were included in the study sample. Total IMNA prevalence was 17.6% of prescriptions. The highest IMNA rate was observed in anilides (22.6%) and the lowest in angiotensin-converting-enzyme (ACE) inhibitors (7.4%). Predictors of IMNA are younger age, American nationality, having a pain-related or mental disorder and being treated by a substitute/resident general practitioner in a resident-training centre. CONCLUSIONS: The rate of IMNA is high when all medications are taken into account. Attempts to strengthen trust in resident general practitioners and improve motivation to initiate a needed medication in the general young and older immigrant population should be addressed in Catalan PC.