Community pharmacist intervention in depressed primary care patients (PRODEFAR study): randomized controlled trial protocol.

Background: Treatment of depression, the most prevalent and costly mental disorder, needs to be improved. Non-concordance with clinical guidelines and non-adherence can limit the efficacy of pharmacological treatment of depression. Through pharmaceutical care, pharmacists can improve patients' compliance and wellbeing. The aim of this study is to evaluate the effectiveness and costeffectiveness of a community pharmacist intervention developed to improve adherence and outcomes of primary care patients with depression. Methods/design: A randomized controlled trial, with 6-month follow-up, comparing patients receiving a pharmaceutical care support programme in primary care with patients receiving usual care. The total sample comprises 194 patients (aged between 18 and 75) diagnosed with depressive disorder in a primary care health centre in the province of Barcelona (Spain). Subjects will be asked for written informed consent in order to participate in the study. Diagnosis will be confirmed using the SCID-I. The intervention consists of an educational programme focused on improving knowledge about medication, making patients aware of the importance of compliance, reducing stigma, reassuring patients about side-effects and stressing the importance of carrying out general practitioners' advice. Measurements will take place at baseline, and after 3 and 6 months. Main outcome measure is compliance with antidepressants. Secondary outcomes include; clinical severity of depression (PHQ-9), anxiety (STAI-S), health-related quality of life (EuroQol-5D), satisfaction with the treatment received, side-effects, chronic physical conditions and sociodemographics. The use of healthcare and social care services will be assessed with an adapted version of the Client Service Receipt Inventory (CSRI). Discussion: This trial will provide valuable information for health professionals and policy makers on the effectiveness and cost-effectiveness of a pharmaceutical intervention programme in the context of primary care. Trial registration: NCT0079419

Barriers and Facilitators for the Implementation of Primary Prevention and Health Promotion Activities in Primary Care : A Synthesis through Meta-Ethnography

Evidence supports the implementation of primary prevention and health promotion (PP&HP) activities but primary care (PC) professionals show resistance to implementing these activities. The aim was to synthesize the available qualitative research on barriers and facilitators identified by PC physicians and nurses in the implementation of PP&HP in adults. A systematic search of three databases was conducted and supported by manual searches. The 35 articles included were translated into each other and a new interpretation of the concepts extracted was generated. The factors affecting the implementation of PP&HP activities in PC according to professionals were fitted into a five-level ecological model: intrapersonal factors, interpersonal processes, institutional factors, community factors and public policy. At the intrapersonal level we find professionals' beliefs about PP&HP, experiences, skills and knowledge, and selfconcept. The attitudes and behavior towards PP&HP of patients, specialists, practice managers and colleagues (interpersonal factors) affect the feasibility of implementing PP&HP. Institutional level: PC is perceived as well-placed to implement PP&HP but workload, lack of time and referral resources, and the predominance of the biomedical model (which prioritizes disease treatment) hamper the implementation of PP&HP. The effectiveness of financial incentives and tools such as guidelines and alarms/reminders is conditioned by professionals' attitudes to them. Community factors include patients' social and cultural characteristics (religion, financial resources, etc.), local referral resources, mass-media messages and pharmaceutical industry campaigns, and the importance given to PP&HP in the curriculum in university. Finally, policies affect the distribution of resources, thus affecting the implementation of PP&HP. Research on barriers and facilitators in the implementation of PP&HP activities in multirisk management is scarce. The conceptual overview provided by this synthesis resulted in the development of practical recommendations for the design of PP&HP in PC. However, the effectiveness of these recommendations needs to be demonstrated

Factors associated with non-participation in and dropout from cardiac rehabilitation programmes: a systematic review of prospective cohort studies

Background: Although evidence exists for the efficacy of cardiac rehabilitation programmes to reduce morbidity and mortality among patients with cardiovascular disease, cardiac rehabilitation programmes are underused. We aimed systematically to review the evidence from prospective cohort studies on factors associated with non-participation in and/or dropping out from cardiac rehabilitation programmes. Methods: MedLine, Embase, Scopus, Open Grey and Cochrane Database were searched for relevant publications from inception to February 2018. Search terms included (a) coronary heart disease and other cardiac conditions; (b) cardiac rehabilitation and secondary prevention; and (c) non-participation in and/or dropout. Databases were searched following the PRISMA statement. Study selection, data extraction and the assessment of study quality were performed in duplicate. Results: We selected 43 studies with a total of 63,425 patients from 10 different countries that met the inclusion criteria. Factors associated with non-participation in and dropout from cardiac rehabilitation were grouped into six broad categories: intrapersonal factors, clinical factors, interpersonal factors, logistical factors, cardiac rehabilitation programme factors and health system factors. We found that clinical factors, logistical factors and health system factors were the main factors assessed for non-participation in cardiac rehabilitation. We also found differences between the factors associated with non-participation and dropout. Conclusions: Several factors were determinant for non-participation in and dropout from cardiac rehabilitation. These findings could be useful to clinicians and policymakers for developing interventions aimed at improving participation and completion of cardiac rehabilitation, such as E-health or home-based delivery programmes. Trial Registration: International Prospective Register of Systematic Reviews (PROSPERO) identifier: CRD42016032973

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

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. 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. 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.

Cost-effectiveness of active monitoring versus antidepressants for major depression in primary health care: a 12-month non-randomized controlled trial (INFAP study)

Background Clinical practice guidelines for the treatment of major depressive disorder (MDD) recommend antidepressants for patients with moderate-severe depression and active monitoring for patients with mild-moderate symptoms. The feasibility and efficiency of active monitoring has not been proven conclusively. The aim of this study is to evaluate the cost-effectiveness of active monitoring in comparison to antidepressants for primary care patients with mild-moderate MDD. Methods/Design This is a 12-month follow-up multicenter observational prospective controlled trial. Patients are enrolled in 12 primary care centers in Barcelona (Spain). Eligible patients are adults (≥18 years-old) with a new episode of MDD that sign a written consent to participate. This is a naturalistic study in which general practitioners (GPs) use their professional judgment to allocate patients into active monitoring or antidepressants groups. GPs treat the patients following their clinical criteria. At baseline, GPs complete a questionnaire (sociodemographic/job characteristics, training, attitude towards depression, interest on mental health and participation in communication groups). Patients’ measurements take place at baseline and after six and 12 months. Main outcome measures include severity of depression (PHQ-9), health-related quality of life (EuroQol-5D) and use of healthcare and social care services (Client Service Receipt Inventory). Secondary outcomes include diagnosis of MDD according to DSM-IV diagnostic criteria (SCID-I), disability (WHO-DAS), anxiety (BAI), comorbidities, medication side-effects and beliefs about medicines (BMQ). The analysis will be done according to the intention to treat analysis. Missing data will be imputed using multiple imputation by chained equations. To minimize the bias resulting from the lack of randomization, a propensity score will be used. Incremental effects and costs between groups will be modelled in each of the imputed databases using multivariate generalized linear models and then combined as per Rubin’s rules. Propensity scores will be used to adjust the models. Incremental cost-effectiveness ratios will be calculated by dividing the difference in costs between groups by the difference in effects. To deal with the uncertainty, resampling techniques with bootstrapping will be used and cost-effectiveness planes and cost-effectiveness acceptability curves will be constructed. A series of sensitivity analyses will be performed. Discussion Given the high burden and costs generated by depressive disorder, it is important that general practitioners treat major depression efficiently. Recent evidence has suggested that antidepressants have low benefits for patients with mild to moderate major depression. For such cases of depression, active monitoring exists as a treatment option, but it is not without difficulties for implementation and its effectiveness and efficiency have not been demonstrated conclusively. The results of the study will provide information on which is the most efficient approach to treat patients with mild to moderate major depression in primary care

Over 40 years (1981-2023) assessing stigma with the Community Attitudes to Mental Illness (CAMI) scale: a systematic review of its psychometric properties

BACKGROUND: The Community Attitudes to Mental Illness (CAMI) scale measures social stigma towards people with mental illness. Although it has been used worldwide, the psychometric properties of the CAMI have not been systematically reviewed. The main aim of this study was to systematically review the psychometric properties of the different versions of the CAMI more than 40 years after of its publication. METHODS: A systematic search was conducted in MEDLINE, PsycINFO, Web of Science, and EMBASE from 1981 (year of publication) to 2023 (present). A double review was performed for eligibility, data extraction, and quality assessment. RESULTS: A total of 15 studies enrolling 10,841 participants were included. The most frequently reported factor structure comprises 3 or 4 factors. Overall, the internal consistency seems adequate for the global scale (α ≥ 0.80), except for CAMI-10 (α = 0.69). Internal consistency of the subscales are not supported, with authoritarianism being the weakest factor (α = 0.27 to 0.68). The stability over time of the total scale has been assessed in the CAMI-40, CAMI-BR, and CAMI-10 (r ≥ 0.39). Few studies have assessed the temporal stability of the CAMI subscales. Most of the correlations with potentially related measures are significant and in the expected direction. CONCLUSIONS: The 3 and 4 factor structure are the most widely reported in the different versions of the CAMI. Even though reliability and construct validity are acceptable, further item refinement by international consensus seems warranted more than 40 years after the original publication. SYSTEMATIC REVIEW REGISTRATION: PROSPERO identification number: CRD42018098956

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

Effectiveness of the “What’s Up!” Intervention to Reduce Stigma and Psychometric Properties of the Youth Program Questionnaire (YPQ): Results from a Cluster Non-randomized Controlled Trial Conducted in Catalan High Schools

Mental disorders are highly prevalent in the general population, and people who experience them are frequently stigmatized. Stigma has a very negative impact on social, academic/professional, and personal life. Considering the high rates of mental disorders among children and adolescents (13.4%) and how critical this age is in the formation of nuclear beliefs, many campaigns to combat stigma have been developed in the last decade, with mixed results. The OBERTAMENT initiative has produced various anti-stigma campaigns in Catalonia (Spain). In the present study, the main objective was to report on the effectiveness of the OBERTAMENT “What’s up!” intervention, a curricular intervention including education and social contact conducted by the teachers in the classroom with teenagers aged between 14 and 18. Prior to this, we examined the psychometric properties of the Youth Program Questionnaire (YPQ), our main outcome measure, in terms of dimensionality, reliability, and validity. A cluster non-randomized controlled trial was conducted to assess this intervention, which was tested in nine high schools situated in the Barcelona region. A convenience sample of 261 students formed the intervention group and 132 the control group (52% women, mean age = 14, SD = 0.47). The assignment to study conditions was conducted by Departament d’Ensenyament (Department of Education), Generalitat de Catalunya (Catalan Government). Participants were evaluated at baseline, post-intervention, and 9-month follow-up. The main outcome measure of this study was the YPQ. The Reported and Intended Behavior Scale (RIBS) was used as secondary outcome measure. The statistical analysis indicated that the YPQ possesses a two-factor structure (stereotypical attitudes and intended behavior) and sound psychometric properties. The multilevel mixed-effects models revealed statistically significant interactions for both study measures and post hoc intragroup analyses revealed a significant but small improvement in the YPQ and RIBS scores in the intervention group. Overall, our results indicate that “What’s up!” produced statistically significant, albeit small improvements in stereotypical attributions and intended behavior toward people with mental disorders. Some methodological limitations and the relatively low levels of stigma observed in our sample may undermine our results. The implications of our results are discussed in relation to stigma research

Effects of Percutaneous Electrical Nerve Stimulation on Countermovement Jump and Squat Performance Speed in Male Soccer Players: A Pilot Randomized Clinical Trial

Abstract: It has been suggested that Percutaneous Electrical Nerve Stimulation (PENS) can increase muscle strength. No previous study has investigated changes in performance in semiprofessional soccer players. This study compares the effects of adding two sessions of PENS to a training program versus the single training program over sport performance attributes (e.g., jump height and squat speed) in healthy soccer players. A cluster-randomized controlled trial was conducted on twenty-three semiprofessional soccer players who were randomized into an experimental (PENS + training program) or control (single training program) group. The training program consisted of endurance and strength exercises separated by 15-min recovery period, three times/week. The experimental group received two single sessions of PENS one-week apart. Flight time and vertical jump height during the countermovement jump and squat performance speed were assessed before and after each session, and 30 days after the last session. Male soccer players receiving the PENS intervention before the training session experienced greater increases in the flight time, and therefore, in vertical jump height, after both sessions, but not one month after than those who did not receive the PENS intervention (F = 4.289, p = 0.003, η 2 p: 0.170). Similarly, soccer players receiving the PENS intervention experienced a greater increase in the squat performance speed after the second session, but not after the first session or one month after (F = 7.947, p < 0.001, η 2 p: 0.275). Adding two sessions of ultrasound-guided PENS before a training strength program improves countermovement jump and squat performance speed in soccer players