El problema de la no iniciación del tratamiento farmacológico: evaluación con métodos cuantitativos

[spa] La no iniciación es un comportamiento que se caracteriza por no empezar aquellos tratamientos farmacológicos prescritos por primera vez. Este comportamiento puede estar influenciado por distintos factores y parámetros contextuales y sus consecuencias se pueden enmarcar dentro del ámbito sanitario y económico. Este fenómeno ha sido escasamente estudiado a nivel mundial, de hecho, en España no se ha evaluado. Los sistemas de información presentes en Cataluña permiten una evaluación global de este comportamiento. Objetivos 1. Describir la prevalencia de no iniciación del tratamiento farmacológico en el sistema público de Atención Primaria (AP) en Cataluña. 2. Estimar los factores de paciente, médico y centro de AP que se asocian a la no iniciación. 3. Estimar la el impacto de la no inicaición en los costes para el sistema público. 4. Estimar el impacto de las políticas de copago en la no iniciación para niveles de aportación económica de los pacientes en distintos perfiles farmacológicos y. Métodos Estudio basados en registros sanitarios del Instituto Catalán de Salud. La variable no iniciación fue creada con datos de prescripción y facturación y se definió como la no dispensación de un fármaco el mes siguiente al de prescripción. Se incluyeron las nuevas prescripciones (sin prescripción de un fármaco del mismo grupo los 3 meses previos) realizadas en AP de los 13 grupos farmacológicos más prescritos y/o costosos. Los datos faltantes fueron imputados mediante imputación simple multivariante. Objetivos 1 y 2: se utilizaron datos de los pacientes que recibieron una nueva prescripción entre julio del 2013 y junio del 2014. Se calcularon las prevalencias de no iniciación para cada grupo farmacoterapéutico y se identificaron los factores predictores de la no iniciación mediante regresión logística multivariante multinivel. Objetivo 3: se siguió una cohorte retrospectiva (3 años) de pacientes con nuevas prescripciones en 2012. Los usos de servicios sanitarios y las bajas laborales de los iniciadores y no iniciadores se compararon mediante regresión lineal multinivel ajustada. Objetivo 4: experimento natural de la prevalencia semanal de no iniciación (enero 2011–junio 2014). Este periodo incluye cinco escenarios distintos relacionados con el copago farmacéutico. Mediante regresión logística segmentada ajustada se calculó la variación de nivel y tendencia de no iniciación en cada periodo. Resultados La prevalencia anual de no iniciación fue de 17.6%. Los grupos farmacológicos con prevalencias más altas y bajas fueron las anilidas (22.6%) y los IECAs (7.4%), respectivamente. Los factores de riesgo de no iniciación fueron ser joven, la nacionalidad americana, tener una patología mental o que curse con dolor, que el médico prescriptor sea substituto o residente y que la prescripción haya sido emitida en un centro docente. Los pacientes iniciadores hicieron un mayor uso de fármacos y de la mayoría de servicios sanitarios que los pacientes no iniciadores o parcialmente iniciadores. Sin embargo, los pacientes iniciadores estuvieron menos días de baja, lo que produjo un retorno económico neto. La no iniciación produjo una mayor carga económica para el sistema a corto-medio plazo. La publicación de noticias sobre el copago provocó una disminución de la no iniciación en todos los grupos poblacionales. La entrada en vigor del copago fijo aumentó la no iniciación en todos los grupos poblacionales. La adhesión del co-seguro pudo aumentar ligeramente la no iniciación, con respecto al período antes del cambio de políticas aunque se observa un efecto protector en los pacientes excluidos de pago. El grupo más afectado fueron los pensionistas con rentas medias y bajas. Conclusiones Esta tesis ha demostrado que la no iniciación es un comportamiento prevalente y que presenta un mayor riesgo en determinadas poblaciones. La no iniciación aumenta las bajas, produciendo costes para el sistema público. Además, podría estar impactando negativamente en la salud por lo que deberían desarrollarse estrategias para minimizarla. Las políticas de copago farmacéutico han impactado en la no iniciación, especialmente en grupos vulnerables (rentas bajas o muy bajas) por lo que se recomienda una revisión de los tramos de copago. Consecuencias Los resultados de esta tesis permitirán afrontar con mayores garantías el diseño de una estrategia que permita minimizar el problema estudiado.[eng] Objectives 1. To estimate the prevalence of Initial Medication Non-Adherence (IMNA). 2. To determine IMNA risk factors related to patient, general practitioner and primary care (PC) center. 3. To estimate the impact of IMNA on costs. 4. To estimate the impact of copayment measures on IMNA. Methods The study is retrospective registries-based on the public PC system of Catalonia (Spain). IMNA was defined as not obtaining a newly prescribed medication (no prescription in the previous three months) in the month following the prescription. The 13 most prescribed and/or costly treatments were included. Missing data was imputed with multivariate simple imputation. Multilevel multivariate logistic and lineal regressions were used to assess risk factors and costs. Segmented logistic regression was used to evaluate copayment policies. Results IMNA prevalence was 17.6%, ranging from 7.4% (ACEIs) and 22.65% (anilides). Being young or American, having a mental or a pain-related disorder or receiving the prescription by a substitute/resident general practitioner and/or in a resident-training center were risk factors of IMNA. Although initially adherent patients made a higher use of medicines and some healthcare services than non-adherent and partially adherent patients, they had lower productivity losses, producing a net economic return. IMNA produced higher economic burden to the system in the short-middle term. The release of news on pharmaceutical copayment caused a decrease in IMNA which was reverted and increased after the establishment of the fixed copayment. The co-insurance copayment also increased IMNA but from this point it began to decrease until the end of the study, having a protective effect in vulnerable populations. The most affected population groups were low and middle-income pensioners. Conclusions This thesis shows that IMNA is a prevalent behavior and that there is a high-risk profile of patient. IMNA increases costs and could have a negative impact on health. Interventions should be implemented to reduce IMNA. Copayment policies affect IMNA, especially in vulnerable populations. The coinsurance thresholds should be revised

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.This study was supported by the Programme of Prevention, Surveillance and Control of Transmissible Diseases (PREVICET), CIBER de Epidemiología y Salud Pública (CIBERESP, CB06/02/0076, CB16/02/00322 and CB16/02/00429), Instituto de Salud Carlos III, Madrid; and the Catalan Agency for the Management of Grants for University Research (AGAUR Grant Number 2017/SGR 1342)

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.

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

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

Impact of the 13-valent conjugated pneumococcal vaccine on the direct costs of invasive pneumococcal disease requiring hospital admission in children aged < 5 years. A prospective study

The lack of invasive pneumococcal disease (IPD) cost studies may underestimate the effect of pneumococcal polysaccharide conjugated vaccines (PCV). The objective of this study was to estimate the direct costs of hospitalized IPD cases. A prospective study was made in children aged <5 years diagnosed with IPD in two high-tech hospitals in Catalonia (Spain) between 2007-2009 (PCV7 period) and 2012-2015 (PCV13 period). Costs were calculated according to 2014 Catalan Health Service rates using diagnostic-related groups. In total, 319 and 154 cases were collected, respectively. Pneumonia had the highest cost (65.7% and 62.0%, respectively), followed by meningitis (25.8% and 26.1%, respectively). During 2007-2015, the costs associated with PCV7 serotypes (Pearson coeffcient (Pc) = 0.79; p = 0.036) and additional PCV13 serotypes (Pc = 0.75; p = 0.05) decreased, but those of other serotypes did not (Pc = 0.23 p = 0.62). The total mean cost of IPD increased in the PCV13 period by 31.4% (¿3016.1 vs. ¿3963.9), mainly due to ICU stay (77.4%; ¿1051.4 vs. ¿1865.6). During the PCV13 period, direct IPD costs decreased due to a reduction in the number of cases, but cases were more severe and had a higher mean cost. During 2015, IPD costs increased due to an increase in the costs associated with non-PCV13 serotypes and serotype 3 and this requires further investigation

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

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

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

El problema de la no-iniciació de tractament farmacològic prescrit a l'atenció primària

Tractament farmacològic prescrit; Prescripció de medicaments; Atenció primària;Prescribed pharmacological treatment; Prescription drugs; Primary care;Tratamiento farmacológico prescrito; Prescripción de medicamentos; Atención primaria;La no iniciació es defineix com el rebuig a començar un tractament farmacològic prescrit per primera vegada a un pacient. La no iniciació podria empitjorar el quadre clínic i afectar la qualitat de vida dels pacients, i també augmentar la despesa sanitària, donat que augmenta la probabilitat de fer una baixa laboral i la durada de la mateixa