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.

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.

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.

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

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

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".

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.

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.

In-patient costs of agitation and containment in a mental health catchment area.

BACKGROUND: There is a scarce number of studies on the cost of agitation and containment interventions and their results are still inconclusive. We aimed to calculate the economic consequences of agitation events in an in-patient psychiatric facility providing care for an urban catchment area. METHODS: A mixed approach combining secondary analysis of clinical databases, surveys and expert knowledge was used to model the 2013 direct costs of agitation and containment events for adult inpatients with mental disorders in an area of 640,572 adult inhabitants in South Barcelona (Spain). To calculate costs, a seven-step methodology with novel definition of agitation was used along with a staff survey, a database of containment events, and data on aggressive incidents. A micro-costing analysis of specific containment interventions was used to estimate both prevalence and direct costs from the healthcare provider perspective, by means of a mixed approach with a probabilistic model evaluated on real data. Due to the complex interaction of the multivariate covariances, a sensitivity analysis was conducted to have empirical bounds of variability. RESULTS: During 2013, 918 patients were admitted to the Acute Inpatient Unit. Of these, 52.8% were men, with a mean age of 44.6 years (SD = 15.5), 74.4% were compulsory admissions, 40.1% were diagnosed with schizophrenia or non-affective psychosis, with a mean length of stay of 24.6 days (SD = 16.9). The annual estimate of total agitation events was 508. The cost of containment interventions ranges from 282€ at the lowest level of agitation to 822€ when verbal containment plus seclusion and restraint have to be used. The annual total cost of agitation was 280,535€, representing 6.87% of the total costs of acute hospitalisation in the local area. CONCLUSIONS: Agitation events are frequent and costly. Strategies to reduce their number and severity should be implemented to reduce costs to the Health System and alleviate patient suffering.

Comparing watchful waiting with antidepressants for the management of subclinical depression symptoms to mild-moderate depression in primary care: a systematic review.

Background: The benefits of watchful waiting (WW) over antidepressants (ADs) for the treatment of depression in primary care (PC) are unclear. Objective: We aimed to systematically review the evidence supporting either WW or ADs for the treatment of subclinical depressive symptoms and mild-moderate depression in a PC setting. Methods: This systematic review was registered at PROSPERO (42016036345). Four electronic sources (EMBASE, PubMed, PsycINFO, Web of Knowledge) were systematically searched from inception to November 2016 for controlled trials comparing WW and ADs in PC following established guidelines. The studies had to include adult population with new symptoms of subclinical depression or mild-moderate depression. Patients in the intervention group should receive a WW approach, while patients in the control group underwent treatment with ADs. The abstraction form included information on the setting, characteristics of the study population, total sample size, size of the control and intervention groups and date of the study. Outcome measures and variability were extracted. Results: The scarcity of studies and the considerable clinical and methodological heterogeneity discouraged us from performing a meta-analysis. Three articles were included and qualitatively synthesized. There was no evidence for the superiority of one treatment option over the other, although two of the studies suggested small differences in favour of ADs when less conservative analyses were conducted (per protocol analysis and analysis not adjusted for missingness predictors). Conclusions: Superiority was not demonstrated by either treatment option. More robust evidence is needed to inform recommendations for the management of depressive symptoms in PC.

Attitudes and intended behaviour to mental disorders and associated factors in catalan population, Spain: cross-sectional population-based survey.

BACKGROUND: Mental disorders have a huge impact on the European population. Two of the main causes of this impact are stigma and discrimination. The aim of this paper is to assess the stigma regarding mental disorder in Catalonia and to explore factors associated with stigma. METHODS: Cross-sectional population-based survey of a representative sample of non-institutionalized adult population (n = 1872). We evaluated attitudes (CAMI: Authoritarianism, Benevolence and Support to Community Mental Health care) and intended behaviour (RIBS) regarding mental disorder and experience of discrimination. Higher scores showed more favourable attitudes and intended behavior. Mean values and percentiles of the scales were calculated. Multivariable regression models were used to assess factors associated with stigma. RESULTS: Mean authoritarianism, benevolence and support to community mental health scores corresponded to the 66th, 90th and 78th percentile, respectively. Mean RIBS score corresponded to the 76th percentile. More favourable attitudes were associated with being male, younger, having a higher education, being Spanish, having suffered a mental disorder and having contact with a person with a mental disorder.Similarly, more favourable intended behaviour was associated with being younger, having secondary education, having Spanish nationality, belonging to a higher social class and having contact with a person with a mental disorder. People with depression or anxiety showed lower discrimination experiences than people with other mental disorders. CONCLUSIONS: The levels of stigma were generally low among the Catalan population. However, efforts should be made to decrease stigma related to authoritarianism. Interventions addressed to reducing stigma should take into account other mental disorders apart from depression or anxiety. They should be focused on older, immigrant population, people with lower educational attainment and people who have not had contact with someone with a mental disorder.

[Impact of pharmaceutical intervention in preventing relapses in depression in Primary Care]. / Impacto de una intervención farmacéutica en la prevención de recaídas en depresión en atención primaria.

OBJECTIVE: To evaluate the long-term impact of a brief pharmacist intervention (PI) compared with usual care (UC) on prevention of depression relapse. DESIGN: randomised controlled clinical trial SETTING: Primary Care PARTICIPANTS: Of the 179 depressed patients initiating antidepressants, the 113 whose clinical symptoms had remitted (main definition) at 6 months assessment were selected for this secondary study (PI=58; UC=55). INTERVENTION: PI was an interview to promote medication adherence when patients get antidepressants from pharmacy. MAIN MEASUREMENTS: Baseline, 3 months, and six-months follow-up assessments were made. The severity of depressive symptoms was evaluated with PHQ9. Patients presenting a remission of symptoms were selected. The patient medical records were reviewed to identify a relapse in the following 12 months by using 4 indicators. RESULTS: There was a lower proportion of patients that relapsed in the PI group than in the UC group 18 months after initiation of treatment, but the difference was not statistically significant either in the intent-to-treat analysis (OR=0.734 [95%CI; 0.273-1.975]) or the per-protocol analysis (OR=0.615 [95%CI; 0.183 -2.060]). All the sensitivity analyses showed consistent results. The sample size and adherence to the protocol in the intervention group were low. CONCLUSION: PI group showed a non-statistically significant tendency towards presenting fewer relapses. This could be related to the improvement in adherence among patients that received the intervention.

Qualitative study of the agitation states and their characterization, and the interventions used to attend them.

INTRODUCTION: Agitation is a common problem in psychiatric care with serious clinical and economic consequences. METHODOLOGY: The aim of the study was to define and characterize the agitation states present in usual medical practice in the acute and emergency units of a psychiatric hospital. Two nominal groups, one with 7 nurses and the other with 10 psychiatrists from the Parc Sanitari Sant Joan de Déu, were established. RESULTS: The nurses described two main states forming the endpoints of a spectrum: from mild (pre-agitation) to severe (agitation). A third state was outlined in which agitation was characterized by disorganized behavior problems. Various care packages were described for each agitation state. The care packages were divided into first, second and third line approaches. The first line approaches (i.e., verbal containment) were used on every (pre)agitated patient. If the first line approach was not effective, the second and third line approaches were implemented, culminating with physical restraint. The psychiatrists described 3 states: a mild initial state (anxiety and irritability), moderate (pre-agitation without aggressiveness) and a severe state of agitation with aggressiveness and/or violence. CONCLUSIONS: In order to avoid progression to a severely agitated state, both groups agreed on the importance of appropriate verbal containment for all states. This would be followed by environmental measures, medication and mechanical restrain depending on the severity of the state.

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

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

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

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

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

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

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.

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.

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.

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

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

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.