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.

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.

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.

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.

Economic Evaluations Informed Exclusively by Real World Data: A Systematic Review.

Economic evaluations using Real World Data (RWD) has been increasing in the very recent years, however, this source of information has several advantages and limitations. The aim of this review was to assess the quality of full economic evaluations (EE) developed using RWD. A systematic review was carried out through articles from the following databases: PubMed, Embase, Web of Science and Centre for Reviews and Dissemination. Included were studies that employed RWD for both costs and effectiveness. Methodological quality of the studies was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. Of the 14,011 studies identified, 93 were included. Roughly half of the studies were carried out in a hospital setting. The most frequently assessed illnesses were neoplasms while the most evaluated interventions were pharmacological. The main source of costs and effects of RWD were information systems. The most frequent clinical outcome was survival. Some 47% of studies met at least 80% of CHEERS criteria. Studies were conducted with samples of 100-1000 patients or more, were randomized, and those that reported bias controls were those that fulfilled most CHEERS criteria. In conclusion, fewer than half the studies met 80% of the CHEERS checklist criteria.

Prevalence of Medication-Dietary Supplement Combined Use and Associated Factors.

INTRODUCTION: The use of medication has increased in recent years in the US while the use of dietary supplements has remained stable but high. Interactions between these two kinds of products may have important consequences, especially in the case of widely used medications such as antihypertensives and antibiotics. The aim of this paper is to estimate the prevalence of potentially serious drug-dietary supplement interactions among tetracyclines, thiazides, and angiotensin II receptor blocker users by means of the NHANES 2013-2014 dataset. METHODS: Data from 2013-2014 NHANES were obtained. Potential interactions analysed were tetracyclines with calcium, magnesium, and zinc, thiazides with vitamin D, and angiotensin II receptors blockers with potassium. Prevalence was calculated for each potential interaction. Logistic regression was used to assess associated factors. RESULTS: 864 prescriptions issued to 820 patients were analysed. Overall prevalence of potential interaction was 49%. Older age and higher educational level were strongly associated with being at risk of a potential interaction. Factors such as age, race, civil status, citizenship, country of birth, BMI, and physical activity did not show notable associations. CONCLUSIONS: Healthcare professionals should be aware of other medical products when they prescribe or dispense a medication or a dietary supplement, especially to the older population and people with a higher educational level.