Concordance between two models of stratification for patients living with HIV infection to providing pharmaceutical care.

OBJECTIVE: To determine the degree of agreement of 2 differents stratification models for pharmaceutical care to people living with HIV. METHODS: This was a single-center observational prospective cohort study of patients with regular follow-up in pharmaceutical care consultations according to the Capacity-Motivation-Opportunity methodology, conducted between January 1 and March 31, 2023. Patients received the pharmacotherapeutic interventions applied routinely to ambulatory care patients according to this model. As part of the usual clinical practice, the presence or absence of the variables that apply to both stratification models were collected. The scores obtained and the corresponding stratification level were collected for each patient according to both stratification models published (ST-2017 and ST-2022). To analyze the reliability between the measurements of 2 numerical score models of the stratification level with both tools, their degree of concordance was calculated using the intraclass correlation coefficient. Likewise, reliability was also evaluated from a qualitative perspective by means of Cohen's Kappa coefficient. Additionally, the existence of correlation between the scores of the 2 models was assessed by calculating Pearson's correlation coefficient. RESULTS: Of the total of 758 patients being followed in the cohort, finally, 233 patients were enrolled. The distribution of patients for each stratification model was: ST-2017: 59.7% level-3, 25.3% level-2, and 15.0% level-1, while for ST-2022: 60.9% level-3, 26.6% level-2, and 12.4% level-1. It was observed that the reclassification was symmetrical (P=.317). The qualitative analysis of the agreement between the models showed a good Cohen's kappa value, (K=0.66). A value of 0.563 was found as the intraclass correlation coefficient. Finally, the correlation analysis between the quantitative scores of the 2 models yielded a Pearson correlation coefficient of 0.86. CONCLUSIONS: The concordance between the 2 models was good, which confirms that the multidimensional adaptation and simplification of the model were correct and that its use can be extended in routine clinical practice.

Impacto de la intervención en un Hospital de Día de Salud Mental sobre el uso posterior de recursos sanitarios y ocupacionales / Impact of an intervention in a mental health day hospital on the subsequent use of health and occupational resources

El presente trabajo examina el impacto del tratamiento intensivo en un Hospital de Día de Salud Mental (HD-SM) sobre el uso posterior de recursos asistenciales (comunitarios y hospitalarios), así como ocupacionales y formativos. Se parte de un diseño descriptivo longitudinal y ambispectivo en el que se estudia de forma innovadora el uso diferencial de los recursos por parte de los usuarios de la red de Salud Mental, antes y después del tratamiento en HD. Finalmente, se discuten las implicaciones y recomendaciones clínicas de acuerdo con los resultados. (AU)

This work examines the impact of intensive treatment in a Mental Health Day Hospital (HD) on the subsequent use of healthcare resources (community and hospital), as well as occupational and training ones. It starts from a longitudinal and ambispective descriptive design in which the differential use of resources by users of the Mental Health network is studied in an innovative way, before and after treatment in HD. Finally, the clinical implications and recommendations are discussed according to the results. (AU)

Early versus late switch: How long should we extend the anti-vascular endothelial growth factor therapy in unresponsive diabetic macular edema patients?

PURPOSE: To compare the results of early versus late switch to the dexamethasone intravitreal implant Ozurdex® in patients with diabetic macular edema who had a poor response to vascular endothelial growth factor inhibitors. METHODS: Retrospective and single-center study conducted, in a real setting, on consecutive diabetic macular edema patients who were switch to an intravitreal dexamethasone implant after a poor response to anti-vascular endothelial growth factor treatment. Study sample was divided into two groups: (1) early-switch group, included those eyes who received three anti-vascular endothelial growth factor injections before switch and (2) late-switch group, included those eyes that received six or more anti-vascular endothelial growth factor injections before switch. The primary end-point was the difference in mean change in best-corrected visual acuity and in central subfoveal thickness. RESULTS: A total of 69 (31 early-switch group and 38 late-switch group) eyes were included. In the early-switch group, median (25-75 quartile range) best-corrected visual acuity significantly increase from 0.2 (0.2-0.5) at baseline to 0.4 (0.3 -0.7) at month 24 (p = 0.0043). Whereas, in the late-switch group, best-corrected visual acuity did not increase (p = 0.8602). Central subfoveal thickness was significantly reduced in both early- and late-switch groups, p = 0.0002 and 0.0038, respectively. The proportion of eyes obtaining a central subfoveal thickness reduction ⩾ 10% was significantly greater in the early-switch group than in the late-switch group (71.0% vs 47.4%, respectively, p = 0.0498). Three (9.7%) and 10 (26.3%) eyes have developed ocular hypertension during the study in the early- and late-switch groups, respectively, p = 0.0816. CONCLUSION: Early switch to Ozurdex in patients who did not adequately respond to anti-vascular endothelial growth factor therapy provided better functional and anatomical outcomes.

Determination of a cutoff value for medication regimen complexity index to predict polypharmacy in HIV+ older patient / Determinación del valor umbral del índice de complejidad de la farmacoterapia para predecir polifarmacia en pacientes VIH+

INTRODUCTION: HIV+ patients have increased their life expectancy with a parallel increase in age-associated co-morbidities and pharmacotherapeutic complexity. The aim of this study was to determine an optimal cutoff value for Medication regimen complexity index (MRCI) to predict polypharmacy in HIV+ older patients. PATIENTS AND METHODS: A transversal observational single cohort study was conducted at a tertiary Hospital in Spain, between January 1st up to December 31st, 2014. Patients included were HIV patients over 50 years of age on active antiretroviral treatment. Prevalence of polypharmacy and it pattern were analyzed. The pharmacotherapy complexity value was calculated through the MRCI. Receiver operating characteristic curve analyses were used to calculate the area under the curve (AUC) for the MRCI value medications to determine the best cutoff value for identifying outcomes including polypharmacy. Sensitivity and specificity were also calculated. RESULTS: A total of 223 patients were included. A 56.1% of patients had polypharmacy, being extreme polypharmacy in 9.4% of cases. Regarding the pattern of polypharmacy, 78.0% had a cardio-metabolic pattern, 12.0% depressive-psychogeriatric, 8.0% mixed and 2.0% mechanical-thyroidal. The ROC curve demonstrated that a value of medication complexity index of 11.25 point was the best cutoff for predict polypharmacy (AUC=0.931; sensitivity= 77.6%; specificity=91.8%). CONCLUSIONS: A cut-off value of 11.25 for MRCI is proposed to determine if a patient reaches the criterion of polypharmacy. In conclusion, the concept of polypharmacy should include not only the number of prescribed drugs but also the complexity of them

INTRODUCCIÓN: La esperanza de vida de los pacientes VIH+ se ha incrementado. De forma paralela han aumentado las comorbilidades asociadas a la edad y la complejidad farmacoterapéutica. El objetivo del estudio es estimar el valor umbral del índice de complejidad de la farmacoterapia (MRCI) para la determinación del criterio de polifarmacia en pacientes VIH+ mayores de 50 años. MÉTODOS: Estudio observacional, trasversal, unicéntrico. Se incluyeron todos los pacientes VIH+ mayores de 50 años, en tratamiento antirretroviral activo entre el 1 enero y 31 diciembre-2015. Se determinó la presencia de polifarmacia y los patrones asociados. La complejidad del tratamiento se calculó con la herramienta MRCI (Universidad de Colorado). Se analizó el índice de complejidad total como marcador cuantitativo de polifarmacia mediante la realización de una curva ROC y el cálculo de su área bajo la curva. Se calculó la sensibilidad y la especificidad de la misma. RESULTADOS: Se incluyeron 223 pacientes. El 56,1% presentó polifarmacia, siendo extrema en el 9,4% de los casos. En relación con el patrón de polifarmacia, el 78,0% presentaron un patrón cardio-metabólico, el 12,0% psico geriátrico-depresivo, el 8,0% mixto y el 2,0% mecánico tiroideo . Se determinó un valor de área bajo la curva ROC de 0,931 con límites entre (0,901-0,962) y p< 0,001. El valor 11,25 de índice de complejidad total de la farmacoterapia proporcionó un valor de especificidad del 92% y una sensibilidad del 78%. CONCLUSIÓN: El valor de 11,25 de índice de complejidad es un buen indicador para conocer los pacientes con polifarmacia. El concepto de polifarmacia no solo debe incluir el número de fármacos que toma el paciente sino incluir también la complejidad del tratamiento

Influence of pharmacist intervention, based on CMO model, to improve activation in HIV patients / Influencia de un programa de intervención farmacéutica, basado en el modelo CMO, para la mejora de la activación de pacientes VIH+

Objectives: The aim of study was to evaluate the influence of pharmacist intervention based on "CMO model", to improve activation in HIV-patients. Material and methods: Longitudinal, prospective, single-center study. Eligible patients were HIV-infected, taking antiretroviral treatment. The collected data included demographic characteristics, clinical and HIV-related and pharmacotherapeutic variables. The primary outcome was the variation of patient activation measured by Spanish adapted patient activation measure questionnaire. This questionnaire assesses people's knowledge, skills and confidence in managing their own health care. The assessment was performed at the beginning and 6 months after the program start, which consisted of individualized interventions planned in the stratification model, a motivational interview and a specific pharmacotherapeutic follow-up. Results: A total of 140 patients were included. The most common regimens prescribed were based on non-nucleoside plus nucleoside reverse transcriptase inhibitor (44.0%) and more than half of the patients had chronic concomitant medication. The patients who achieved the highest activation level increased from 28.1% to 68.3% (p<0.0005). The relationship between this increase in patient activation and the stratification level that occurs in largest increases in patients with a low need level, where it was observed an improvement in the percentage of patients with high activation from 28.3% to 74.3% (p<0.001) after intervention. The percentage of patients with adequate adherence to concomitant treatment increased by 18.4% (p = 0.035). Baseline PAM values showed high activation for 28.6% (40 patients), intermediate for 43.6% (61) and low for 27.9% (39). Conclusion: CMO model has an important role for patient activation, improving adherence and health outcomes for HIV+ patients

Objetivo: Evaluar la influencia de un programa de intervenciones basadas en el nuevo modelo CMO para pacientes VIH+ en la mejora de su activación con su tratamiento. Material y métodos: Estudio longitudinal, prospectivo, unicéntrico. Se incluyeron pacientes VIH adultos en tratamiento antirretroviral activo. Se recogieron variables demográficas, clínicas y relacionadas con el VIH y variables farmacoterapéuticas. La variable principal fue la variación del nivel de Activación de los pacientes medidos por el cuestionario "patient activation measure" (PAM). Este cuestionario valora el conocimiento, las habilidades y la confianza de los pacientes para ser responsable de su propio cuidado. El cuestionario se facilitó a los pacientes en la visita de inicio y a los 6 meses del inicio del programa que consistió en aplicar las intervenciones diseñadas en el modelo de estratificación junto con una entrevista motivacional y un seguimiento farmacoterapéutico específico fuera de las consultas habituales. Resultados: Se incluyeron 140 pacientes. El 44% de los pacientes estaba en tratamiento con un régimen compuesto por 2ITIAN+ITINN y más del 50% presentaban medicación concomitante crónica. En relación a la variable principal, la evolución del número de pacientes que alcanzaron el nivel más alto de activación pasó de un 28,1% a un 68,3% (p<0,0005). El análisis de esta relación determinó que los mayores incrementos se producen en los pacientes con un nivel de necesidad de Atención Farmacéutica bajo, donde se observó un incremento del porcentaje de pacientes con activación alta de un 28,3% a un 74,3% (p<0,001). El porcentaje de pacientes con buena adherencia al tratamiento antirretroviral se incrementó un 18,4% al tratamiento concomitante (p=0,035). Los valores de PAM basales recogidos incluyeron una alta activación para el 28,6% (40 pacientes), medio para el 43,6% (61) y bajo para el 27,9% (39). Conclusión: El programa de intervenciones basado en el modelo CMO influye en la activación de los pacientes y puede mejorar la adherencia y otros resultados en salud en los pacientes VIH+

Iris-claw intraocular lens implantation: Efficiency and safety according to technique.

PURPOSE: To evaluate the safety, refractive and visual results of an iris-claw intraocular lens for aphakia (Artisan) according to the technique used. SETTING: Ophthalmology Department, Valme University Hospital and Oftalvist Clinic, Seville, Spain. DESIGN: Retrospective case series. METHODS: This study evaluated the outcomes of iris-claw IOL implantations performed by the same surgeon between 2011 and 2017. The results were analyzed by the incision type (corneal versus scleral tunnel) and lens position (prepupillary versus retropupillary). RESULTS: Seventy-six eyes (75 patients) were included. The postoperative uncorrected (UDVA) and corrected (CDVA) distance visual acuities were significantly better than the preoperative acuities (P < .001). The UDVA was 20/40 or better in 41.7% of patients, and had the CDVA was 20/40 or better in 68.1% of patients. The mean UDVA was significantly better in the scleral tunnel incision group (0.29 logarithm of the minimum angle of resolution [logMAR] ± 0.41 [SD]) than in the corneal incision group (0.66 ± 0.45 logMAR) (P < .001). The mean surgically induced astigmatism in the scleral tunnel incision group (0.73 ± 0.62 diopter [D]) was significantly lower than in the corneal incision group (2.49 ± 1.36 D) (P < .001). Although endothelial cell loss was lower in the retropupillary position, the difference was not significant (P = .07.) CONCLUSION: Implantation of the iris-claw IOL in the retropupillary position and through a scleral tunnel incision was an effective and safe alternative to aphakia without capsule support, providing better refractive results compared with other techniques.

Effect of a Structured Pharmaceutical Care Intervention Versus Usual Care on Cardiovascular Risk in HIV Patients on Antiretroviral Therapy: INFAMERICA Study.

BACKGROUND: HIV+ patients have increased their life expectancy with a parallel increase in age-associated comorbidities. OBJECTIVE: To determine the effectiveness of an intensive pharmaceutical care follow-up program in comparison to a traditional model among HIV-infected patients with moderate/high cardiovascular risk. METHOD: This was a multicenter, prospective, randomized study of a structured health intervention conducted between January-2014 and June-2015 with 12 months of follow-up at outpatient pharmacy services. The selected patients were randomized to a control group (usual care) or intervention group (intensive pharmaceutical care). The interventional program included follow-up of all medication taken by the patient to detect and work toward the achievement of pharmacotherapeutic objectives related to cardiovascular risk and making recommendations for improving diet, exercising, and smoking cessation. Individual motivational interview and periodic contact by text messages about health promotion were used. The primary end point was the percentage of patients who had reduced the cardiovascular risk index, according to the Framingham-score. RESULTS: A total of 53 patients were included. As regards the main variable, 20.7% of patients reduced their Framingham-score from high/very high to moderate/low cardiovascular risk versus 12.5% in the control group ( P=0.016). In the intervention group, the number of patients with controlled blood pressure increased by 32.1% ( P=0.012); 37.9% of patients overall stopped smoking ( P=0.001), and concomitant medication adherence increased by 39.4% at the 48-week follow-up ( P=0.002). Conclusion and Relevance: Tailored pharmaceutical care based on risk stratification, motivational interviewing, and new technologies might lead to improved health outcomes in HIV+ patients at greater cardiovascular risk.

Identification of the Medication Regimen Complexity Index as an Associated Factor of Nonadherence to Antiretroviral Treatment in HIV Positive Patients.

BACKGROUND: Multiple studies have identified a relationship between the complexity of a medication regimen and non-adherence. However, most studies in people who live with HIV (PLWH) have focused on antiretroviral use and have failed to consider the impact of other medications. OBJECTIVE: The aim of our study is to identify the Medication Regimen Complexity Index (MRCI) as an associated factor for nonadherence to antiretroviral treatment (ART). The secondary aim is to analyze the relationship between clinical and pharmacotherapeutical variables and adherence to antiretroviral treatment and to generate an adherence model. METHODS: A transversal, observational study. Patients included were PLWH over 18 years of age on active antiretroviral therapy. Patients who participated in clinical trials or who did not meet the inclusion criteria were excluded. We had studied HIV transmission mode, viral load, treatment status, number of comorbidities and complexity index as factors associated with adherence to ART. RESULTS: We included 619 patients in the study. Number of comorbidities ( p = 0.021; OR = 1.038-1.570); viral load ( p = 0.023; OR = 1.108-4.505) and MRCI ( p < 0.001; OR = 1.138-1.262) (ART and concomitant treatment) were the independent associated factors to ART nonadherence. The value of the Hosmer and Lemeshow test confirmed the validity of this model (P = 0.333). CONCLUSION: A higher MRCI was associated with non-adherence. Therefore, the regimen complexity calculation may be appropriate in daily practice for identifying patients at a higher risk of becoming non-adherent.

Calidad de vida con órtesis de compresión frente a apósito en el postoperatorio de pacientes con cirugía conservadora de cáncer de mama / Quality of life in patients with compression orthoses compared with those with compressive bandage during the postoperative period after conservative surgery for breast cancer

Objetivos. Comparar el efecto producido por el uso de una órtesis de compresión controlada (sujetador de compresión) frente al apósito compresivo clásico, sobre la calidad de vida y otras características que también pueden incidir en esta como el bienestar, la satisfacción estética, la facilidad de uso y el dolor de pacientes intervenidas de cirugía conservadora de cáncer de mama. Método. Estudio prospectivo aleatorizado sobre 198 casos distribuidos en 2 grupos: apósito (n=88) y órtesis (n=99), recogiendo variables relacionadas con la calidad de vida, facilidad de uso, bienestar, satisfacción estética y dolor. Se realizó un estudio comparativo y de la evolución temporal de las variables durante el primer mes postoperatorio utilizándose para la valoración de la calidad de vida el cuestionario de salud general SF-12 cuyo objetivo es evaluar el grado de bienestar y capacidad funcional de las pacientes. Para la valoración del grado de facilidad de uso, bienestar y satisfacción estética se emplearon escalas de Likert. En cuanto a la intensidad del dolor fue valorado con una escala visual-analógica graduada numéricamente (0 a 10). Resultados. Se encontraron diferencias significativas en la calidad de vida a favor del uso de la órtesis (p<0,0005). En cuanto a la valoración de la facilidad de uso, bienestar y la satisfacción estética también existen diferencias significativas (p<0,0005) entre los grupos, y en cada uno de los momentos de tiempo del postoperatorio. La intensidad del dolor mejoró también significativamente en el grupo experimental a los 7 (p=0,002) y a los 15 días (p=0,012). Conclusiones. La calidad de vida en el postoperatorio de las pacientes tratadas con órtesis es superior a la de las pacientes tratadas con apósito, mejorando también la facilidad de uso, bienestar, satisfacción estética y la intensidad del dolor, constituyendo por tanto una alternativa válida en la recuperación postoperatoria de las pacientes intervenidas de cirugía conservadora de cáncer de mama

Objectives. To compare the effects of controlled compression orthoses (compression bra) with those of traditional compressive bandage after conservative surgery for breast cancer. The analysed effects focussed on patients’ quality of life, convenience, aesthetic satisfaction, user-friendliness and pain after breast-conserving surgery. Method. A randomised prospective study was carried out in 198 patients distributed in 2 groups: bandage (n=88) and orthoses (n=99). The following variables were collected: quality of life, user-friendliness, convenience, aesthetic satisfaction and pain. This comparative study also analysed the temporal evolution of the variables during the first postoperative month. To assess quality of life, the SF-12 general health questionnaire was used, which aims to evaluate patients’ degree of well-being and functional capacity. To assess the degree of user-friendliness, convenience and aesthetic satisfaction, Likert scales were used. Pain intensity was assessed by using a numerically numbered (0 to 10) visual-analogue scale. Results. Significant differences were found in relation to quality of life favouring the use of orthoses (P<.0005). There were also differences (P<.0005) in the assessment of user-friendliness, convenience and aesthetic satisfaction between the two groups and throughout the postoperative period. Pain intensity also improved significantly in the experiment group after 7 (P=.002) and 15 days (P=.012). Conclusions. Quality of life during the postoperative period was higher among patients treated with orthoses than among those treated with bandages. User-friendliness, convenience, aesthetic satisfaction and pain intensity also improved. Therefore, the use of orthoses is a valid alternative for postoperative recovery in patients undergoing breast-conserving surgery

Evolución del índice de complejidad de la terapia antirretroviral en paciente VIH en una cohorte de práctica clínica real / Evolution of the Complexity Index of the antiretroviral therapy in HIV+ patients in a real life clinical practice

Introducción. La infección por VIH ha supuesto uno de los mayores éxitos en el mundo sanitario, principalmente por la aparición del tratamiento antirretroviral (TAR). La complejidad de este tipo de tratamiento ha sido uno de los factores decisivos en el seguimiento de estos pacientes. Material y métodos. Estudio observacional analítico, unicéntrico, retrospectivo. Se incluyeron todos los pacientes mayores de 18 años diagnosticados de VIH que recibieron TAR en seguimiento por la consulta de atención farmacéutica de patologías víricas durante el año 2015. Se observó la evolución del índice de complejidad (IC) del TAR a lo largo del tiempo y la relación de este con la adherencia al TAR y al tratamiento concomitante. Resultados. Se incluyeron un total de 619 pacientes en el estudio con una edad media de 47,03±10,18 años. Existió una reducción en el IC a lo largo de los años, produciéndose un descenso significativo en el año 2013 y en el 2015. Los resultados obtenidos tras el análisis de las variables secundarias mostraron una relación significativa entre la adherencia al TAR y el IC de este. Los pacientes adherentes presentaron un IC más bajo (3,5) que los pacientes no adherentes (4,25) (p=0,003). Conclusiones. La complejidad del TAR va reduciéndose debido principalmente a las nuevas estrategias de tratamiento y a la aparición cada vez mayor de coformulaciones farmacéuticas. Una reducción en la complejidad del TAR supone una mejor adherencia a este (AU)

Introduction. HIV infection has been one of the biggest successes in the healthcare world, mainly due to the appearance of antiretroviral treatment (ART). The complexity of this type of treatment has been one of the decisive factors in the follow-up of these patients. Methods. An analytical, unicentric, retrospective observational study. We included all patients older than 18 years of age who were diagnosed with HIV who received ART in follow-up for the consultation of pharmaceutical pathology care during the year 2015. The evolution of the complexity index of ART over time and its relation with adherence to ART and concomitant treatment. Results. A total of 619 patients were included in the study with a mean age of 47.03 ± 10.18 years. There was a reduction in CI over the years, with a significant decrease in the year 2013 and in 2015. The results obtained after the analysis of the secondary variables showed a significant relation between the adhesion to the ART and the CI of this. Patients have a lower CI (3.5) than non-adherent patients (4.25). (P = 0.003) Conclusions. The complexity of ART is being reduced mainly by new treatment strategies and the increasing appearance of pharmaceutical coformulations. A reduction in the complexity of ART assumes a better adherence to it (AU)

Relationship between pharmacotherapy complexity and patient satisfaction with treatment for hepatitis C / Relación entre la complejidad farmacoterapéutica y la satisfacción del paciente con el tratamiento frente a la hepatitis C

Objective: To establish the relationship between the complexity of treatment for hepatitis C and patient satisfaction. Method: An observational, prospective, single-center study, which included HCV patients treated between October 2014 and February 2016. The primary endpoint was the assessment of satisfaction with treatment, measured by the HCV-ESTAR questionnaire, structured into two dimensions: clinical and lifestyle satisfaction, on a 0-60 score. A reliability analysis was performed. The data collected were: treatment prescribed for HCV, concomitant medication, and Sustained Viral Response. The complexity index of the complete pharmacotherapy was calculated by the computer application MRCI. T-Student was used to identify the complexity of treatment as a marker of dissatisfaction. Results: The study included 171 patients (83.0% male). The mean satisfaction score was 47.9±7.5. The reliability of the complete questionnaire was high (Cronbach alpha, 0.864; intraclass coefficient, 0.843). There was correlation between the Complexity Index and satisfaction (P<0.05). Finally, patients with higher values of satisfaction presented a higher response rate (p=0.029) (AU)

Objetivo: Establecer la relación entre complejidad del tratamiento frente a la hepatitis C y la satisfacción con el mismo. Método: Estudio observacional, prospectivo, unicéntrico. Se incluyeron pacientes con VHC, tratados entre octubre-2014 y febrero-2016. La variable principal fue la valoración de satisfacción con el tratamiento, medida según el cuestionario ESTAR-VHC, estructurado en dos dimensiones: satisfacción clínica y con el estilo de vida, puntuándose de 0-60. Se realizó un análisis de fiabilidad. Se recogió el tratamiento frente al VHC prescrito, la medicación concomitante y la respuesta viral sostenida. El índice de complejidad de la farmacoterapia completa se calculó a través de la aplicación informática MRCI. Para identificar la complejidad del tratamiento como marcador de insatisfacción se utilizó la t-Student. Resultados: Se incluyeron 171 pacientes (83,0% hombres). La media de puntuación sobre satisfacción fue 47,9±7,5. La fiabilidad del cuestionario completo fue elevada (alfa Cronbach=0,864, coeficiente intraclase=0,843). Existió correlación entre IC y la satisfacción (P<0,05). Por último, los pacientes con mayores valores de satisfacción presentaron mayor porcentaje de respuestas (p=0,029) (AU)

Relationship between pharmacotherapy complexity and patient satisfaction with treatment for hepatitis C.

OBJECTIVE: To establish the relationship between the complexity of treatment for hepatitis C and patient satisfaction. Method: An observational, prospective, single-center study, which included HCV patients treated between October 2014 and February 2016. The primary endpoint was the assessment of satisfaction with treatment, measured by the HCV-ESTAR questionnaire, structured into two dimensions: clinical and lifestyle satisfaction, on a 0-60 score. A reliability analysis was performed. The data collected were: treatment prescribed for HCV, concomitant medication, and Sustained Viral Response. The complexity index of the complete pharmacotherapy was calculated by the computer application MRCI. T-Student was used to identify the complexity of treatment as a marker of dissatisfaction. RESULTS: The study included 171 patients (83.0% male). The mean satisfaction score was 47.9±7.5. The reliability of the complete questionnaire was high (Cronbach alpha, 0.864; intraclass coefficient, 0.843). There was correlation between the Complexity Index and satisfaction (P<0.05). A reduction of 5 points in the Complexity Index increased fourfold the value of satisfaction with treatment (p<0.0001). Similarly, a reduction in 12 points in the Concomitant Medication Index doubled the satisfaction (p=0.028). Regarding the overall complexity, 10 points less doubled the satisfaction (p<0.05). Finally, patients with higher values of satisfaction presented a higher response rate (p=0.029). CONCLUSIONS: An increase in pharmacotherapeutical complexity has an impact on satisfaction, and at the same time, on achieving Sustained Viral Response.

Objetivos: Establecer la relación entre complejidad del tratamiento frente a la hepatitis C y la satisfacción con el mismo.Método: Estudio observacional, prospectivo, unicéntrico. Se incluyeron pacientes con VHC, tratados entre octubre-2014 y febrero-2016. La variable principal fue la valoración de satisfacción con el tratamiento, medida según el cuestionario ESTAR-VHC, estructurado en dos dimensiones: satisfacción clínica y con el estilo de vida, puntuándose de 0-60. Se realizó un análisis de fiabilidad. Se recogió el tratamiento frente al VHC prescrito, la medicación concomitante y la respuesta viral sostenida. El índice de complejidad de la farmacoterapia completa se calculó a través de la aplicación informática MRCI. Para identificar la complejidad del tratamiento como marcador de insatisfacción se utilizó la t-Student.Resultados: Se incluyeron 171 pacientes (83,0% hombres). La media de puntuación sobre satisfacción fue 47,9±7,5. La fiabilidad del cuestionario completo fue elevada (alfa Cronbach=0,864, coeficiente intraclase= 0,843). Existió correlación entre IC y la satisfacción (P<0,05). Una disminución de 5 puntos en el índice de complejidad multiplicó por cuatro el valor de la satisfacción con el tratamiento (p<0,0001). Análogamente, 12 puntos menos del índice de medicación concomitante duplicó la satisfacción (p=0,028). Respecto a la complejidad global, 10 puntos menos dobló la satisfacción (p<0,05). Por último, los pacientes con mayores valores de satisfacción presentaron mayor porcentaje de respuestas (p=0,029).Conclusiones: El incremento en la complejidad farmacoterapéutica influye en la satisfacción y, paralelamente, en la obtención de respuesta viral sostenida.

Estudio comparativo aleatorizado de la utilidad de órtesis de compresión controlada frente al apósito compresivo en el postoperatorio inmediato de la cirugía conservadora del cáncer de mama / A randomised controlled trial of the efficacy of a controlled compression garment versus compressive bandaging in the immediate postoperative period after breast cancer-conserving surgery

Objetivos. Comparar la incidencia conjunta e individual de complicaciones postoperatorias, comodidad y calidad de vida dependiendo del uso de apósito compresivo o de órtesis específica de compresión controlada. Pacientes y método. Estudio prospectivo aleatorizado sobre 198 casos distribuidos en 2 grupos: apósito (n=88) y órtesis (n=99), recogiendo variables relacionadas con complicaciones inmediatas postoperatorias y satisfacción en la calidad de vida. Se realizó un estudio comparativo y de la evolución temporal de las variables durante el primer mes postoperatorio. Resultados. La incidencia de complicaciones totales fue significativamente menor con órtesis a 7 días (p=0,032) y a 15 días(p=0,009). Se evidenció una reducción significativa del dolor con órtesis a 7 días (p=0,002) y a 15 días (p=0,012) y en la incidencia de lesiones cutáneas: 0-2% en órtesis frente a 35% con apósito (p<0,0005). También se encontraron diferencias significativas en la calidad de vida a favor del uso de órtesis (p<0,0005). Conclusiones. El uso de órtesis de compresión controlada en el postoperatorio inmediato de la cirugía conservadora de cáncer de mama reduce del 32 al 15% la incidencia conjunta de complicaciones posquirúrgicas y mejora en términos de eficacia, seguridad y comodidad al apósito compresivo habitual (AU)

Objectives. To compare the overall and individual incidence of postoperative complications, comfort and quality of life resulting from the use of compressive bandaging versus a specific controlled compression garment. Patients and method. A randomised controlled trial was conducted in 198 patients distributed in 2 groups: bandaging (n=88) and compression garment (n=99). Variables related to immediate postoperative complications and satisfaction with quality of life were collected. Changes in the variables were compared in the 2 groups during the first postoperative month. Results. The incidence of total complications was significantly lower with the compression garment: 7 days (P=.032) and 15 days (P=.009). Pain was significantly reduced with the compression garment: 7 days (P=.002) and 15 days (P=.012). The incidence of skin injury was also significantly reduced: 0-2% with the compression garment versus 35% with bandaging (P<0.0005). Significant differences were found in quality of life in favour of the use of the compression garment (P<0.0005). Conclusions. The use of a specific controlled compression garment in the immediate postoperative period after breast cancer-conserving surgery reduces the likelihood of postoperative complications from 32 to 15% and enhanced efficacy, safety, and patient comfort compared with the usual compressive dressing (AU)

Persistence to single-tablet regimen versus less-drug regimen in treatment experienced HIV-infected patients on antiretroviral therapy.

BACKGROUND: Decreased antiretroviral therapy persistence is associated with increased rates of virologic failure, development of antiretroviral resistance, and increased morbidity and mortality. Different therapeutic strategies, such as single-tablet regimens (STR) and less-drug regimens (LDR), have been developed in order to simplify antiretroviral therapy (ART) and increase persistence. OBJECTIVES: The primary objective was to compare antiretroviral persistence among patients receiving STRs and patients receiving LDRs. A secondary objective was to identify factors associated with non-persistence. METHODS: This was a retrospective study that included treatment- experienced HIV-infected patients who received ART based on STR or LDR. Baseline patient characteristics collected included demographic information, HIV risk transmission, substance abuse during the therapy, presence of psychiatric disorder and hepatitis B or C virus infection. Kaplan-Meier analysis and Log rank was utilized to compare persistence to STR and LDR. To identify independent predictors of non-persistence we developed a multivariate Cox regression analysis. RESULTS: A total of 244 patients were included, 176 with STR and 68 with LDR. 60 (34.1%) patients discontinued in the STR group and 13 (19.1%) in the LDR group. The Cox regression model showed that the only variable associated with higher risk of non-persistence was the substance abuse (HR = 2.59; p = 0.005). Adverse events were the main reason for ART discontinuation in the STR group and virologic failure in the LDR group. CONCLUSIONS: Persistence to STR and LDR seems to be similar in pretreated HIV-infected patients. Drug abuse was the only factor identified with a higher risk of non-persistence.

Objetivos: Analizar y comparar la persistencia entre las estrategias basadas en Single-Tablet Regimen (STR) y Less Drug Regimen (LDR) en pacientes VIH+. El objetivo secundario del estudio fue determinar factores predictores de persistencia. Material y métodos: Estudio observacional retrospectivo que incluyo los siguientes criterios: pacientes VIH+ con tratamiento antirretroviral (TAR) con un regimen basado en STR o LDR. Se recogieron variables demograficas, factores de riesgo de adquisicion, consumo de drogas, presencia de algun trastorno psiquiatrico y coinfeccion por el virus de la hepatitis B o C. Para comparar la persistencia entre ambas estrategias se realizo un analisis de supervivencia de Kaplan-Meir y se aplico el metodo de log-rank. Se realizo un analisis de regresion de Cox para identificar los factores predictores de persistencia. Resultados: Se incluyeron 244 pacientes, 176 con STR y 68 con LDR. El 34,1% (n = 60) de los pacientes que recibieron un regimen STR abandonaron y en el LDR el 19,1% (n = 13). Los efectos adversos fueron la principal causa de abandono del tratamiento en los pacientes que recibieron STR y el fallo virologico en el regimen LDR. La persistencia de las estrategias STR y LDR fue similar, no encontrandose diferencias estadisticamente significativas entre ambas. El consumo de drogas fue el unico factor predictivo asociado con una menor persistencia (HR = 2,59; p = 0,005). Conclusiones: La persistencia entre los regimenes STR y LDR fue similar, no detectandose diferencias significativas entre ambos. El consumo de drogas fue el unico factor independiente asociado con una menor persistencia del tratamiento antirretroviral.

[Patients'adherence-related beliefs about medicines prescribed for long-term conditions in HIV patients]. / Influencia de las creencias hacia los medicamentos en la adherencia al tratamiento concomitante en pacientes VIH+

PURPOSE: To assess adherence and beliefs about long-term medicines for other chronic conditions among HIV-infected patients as well as to evaluate their relationship. METHOD: A cross-sectional study was conducted from may to july 2014 in HIV-infected patients treated with antiretroviral treatment (ART) and ≥1 long-term medicines for other chronic diseases. The variables analysed in the study were demographics: sex, age, education, employment status, living situation; clinical: mode of transmission, HIV plasma viral load, T-CD4+, CDC classification; and pharmacotherapeutics: type of ART, adherence to long-term medicines for other chronic conditions using the 4-item Morisky Medication Adherence (MMAS) Scale. MMAS scores were dichotomised into adherent/non-adherent. The Beliefs about Medicines Questionnaires (BMQ) was used to assess patients' beliefs about the long-term medicines. The BMQ-Specific has two scales (necessity and concern) with five questions each that uses a 5-point Likert scale. Internal consistency within BMQ scales was measured with Cronbach's α and their association with adherence was assessed with t-Student tests, using SPSS 20.0. RESULTS: We included 126 patients (80.4% male, mean age 49.0 ± 8.3). The mean of long-term medicines was 2.9 ± 2.0. The percentage of non-adherent patients was 54.0%. 63.5% of patients had AIDS, that showed statistically significant relationship with non-adherence. Concerns were negatively related to self-reported adherence (14.6 ± 5.7 vs. 12.1 ± 6.1; p=0.019). No relationship between adherence and necessity was found (17.3 ± 5.6 vs. 18.8 ± 4.4; p=0.188). Internal consistency for BMQ-Specific was high (Cronbach's α=0.724). CONCLUSION: Higher concerns are associated with higher self-reported adherence to long-term medicines in HIV infected-patients.

Objetivo: Determinar a adherencia y las creencias hacia la medicacion para patologias cronicas concomitantemente prescrita al TAR en pacientes infectados por el VIH, asi como determinar si existen diferencias significativas en las creencias entre los pacientes adherentes y no adherentes al los tratamientos concomitantes al TAR. Método: Estudio transversal llevado a cabo durante mayo y julio 2014 en pacientes VIH+ con tratamiento antirretroviral y uno o mas medicamentos para patologias cronicas. Se recogieron variables sociodemograficas: edad, sexo, educacion, situacion laboral, si vivia solo; clinicas: modo de transmision de la infeccion, carga viral plasmatica, T-CD4, estadio; y farmacoterapeuticas: tipo de tratamiento antirretroviral, comedicacion y adherencia a esta mediante el cuestionario Morisky. Se midieron las creencias hacia dicha comedicacion mediante el Beliefs about Medicines Questionnare (BMQ), que incluye dos escalas, necesidad y preocupacion. Los datos se analizaron con SPSSR 20.0. Se aplico la prueba t de Student. La fiabilidad del cuestionario se estimo mediante el alfa de Cronbach. Resultados: Se incluyeron 126 pacientes (80.4% hombres, 49}8.3 anos). El numero de medicamentos concomitantes fue 2.9}2.0. Se clasifico como no adherente al 54.0%. El 63.5% tenia sida, que se identifico como una variable independiente predictora de no adherencia. Las diferencias en la escala de preocupacion entre los pacientes no adherentes y adherentes fue estadisticamente significativa (14.6}5.7 vs. 12.1}6.1; p=0.019), mientras que en aquellas relativas a la necesidad no hubo diferencias (17.3}5.6 vs. 18.8}4.4; p=0.188). La fiabilidad del BMQ-especifico, asi como de las escalas de necesidad y preocupacion, fue buena (0.724, 0.794, 0.785, respectivamente). Conclusiones: Los pacientes VIH positivos con otras patologias cronicas no adherentes presentan creencias negativas relacionadas con la preocupacion en cuanto a la comedicacion.

Influencia de las creencias hacia los medicamentos en la adherencia al tratamiento concomitante en pacientes VIH+ / Patients’adherence-related beliefs about medicines prescribed for long-term conditions in HIV patients

Objetivo: Determinar a adherencia y las creencias hacia la medicación para patologías crónicas concomitantemente prescrita al TAR en pacientes infectados por el VIH, así como determinar si existen diferencias significativas en las creencias entre los pacientes adherentes y no adherentes al los tratamientos concomitantes al TAR. Método: Estudio transversal llevado a cabo durante mayo y julio 2014 en pacientes VIH+ con tratamiento antirretroviral y uno o más medicamentos para patologías crónicas. Se recogieron variables sociodemográficas: edad, sexo, educación, situación laboral, si vivía solo; clínicas: modo de transmisión de la infección, carga viral plasmática, T-CD4, estadío; y farmacoterapéuticas: tipo de tratamiento antirretroviral, comedicación y adherencia a ésta mediante el cuestionario Morisky. Se midieron las creencias hacia dicha comedicación mediante el Beliefs about Medicines Questionnare (BMQ), que incluye dos escalas, necesidad y preocupación. Los datos se analizaron con SPSS® 20.0. Se aplicó la prueba t de Student. La fiabilidad del cuestionario se estimó mediante el alfa de Cronbach. Resultados: Se incluyeron 126 pacientes (80.4% hombres, 49±8.3 años). El número de medicamentos concomitantes fue 2.9±2.0. Se clasificó como no adherente al 54.0%. El 63.5% tenía sida, que se identificó como una variable independiente predictora de no adherencia. Las diferencias en la escala de preocupacion entre los pacientes no adherentes y adherentes fue estadisticamente significativa (14.6±5.7 vs. 12.1±6.1; p=0.019), mientras que en aquellas relativas a la necesidad no hubo diferencias (17.3±5.6 vs. 18.8±4.4; p=0.188). La fiabilidad del BMQ-específico, así como de las escalas de necesidad y preocupación, fue buena (0.724, 0.794, 0.785, respectivamente). Conclusiones: Los pacientes VIH positivos con otras patologías crónicas no adherentes presentan creencias negativas relacionadas con la preocupación en cuanto a la comedicación

Purpose: To assess adherence and beliefs about long-term medicines for other chronic conditions among HIV-infected patients as well as to evaluate their relationship. Method: A cross-sectional study was conducted from may to july 2014 in HIV-infected patients treated with antiretroviral treatment (ART) and >1 long-term medicines for other chronic diseases. The variables analysed in the study were demographics: sex, age, education, employment status, living situation; clinical: mode of transmission, HIV plasma viral load ,T-CD4+, CDC classification; and pharmacotherapeutics: type of ART, adherence to long-term medicines for other chronic conditions using the 4-item Morisky Medication Adherence (MMAS) Scale. MMAS scores were dichotomised into adherent/non-adherent. The Beliefs about Medicines Questionnaires (BMQ) was used to assess patients' beliefs about the long-term medicines. The BMQ-Specific has two scales (necessity and concern) with five questions each that uses a 5-point Likert scale. Internal consistency within BMQ scales was measured with Cronbach's αand their association with adherence was assessed with t-Student tests, using SPSS 20.0. Results: We included 126 patients (80.4% male, mean age 49.0±8.3). The mean of long-term medicines was 2.9±2.0. The percentage of non-adherent patients was 54.0%. 63.5% of patients had AIDS, that showed statistically significant relationship with non-adherence. Concerns were negatively related to self-reported adherence (14.6±5.7 vs. 12.1±6.1; p=0.019). No relationship between adherence and necessity was found (17.3±5.6 vs. 18.8±4.4; p=0.188). Internal consistency for BMQ-Specific was high (Cronbach's α=0.724). Conclusion: Higher concerns are associated with higher self-reported adherence to long-term medicines in HIV infected-patients

Influence of treatment complexity on adherence and incidence of blips in HIV/HCV coinfected patients.

BACKGROUND: The addition of antihepatitis C therapy to highly active antiretroviral treatment (HAART) in human immunodeficiency virus (HIV)/hepatitis C virus (HCV) coinfected patients leads to an increase in the treatment complexity that may result in decreased adherence. Blips, defined as intermittent episodes of detectable low-level HIV viremia, may be an indication of poor adherence to HAART. OBJECTIVES: To (a) determine the influence of adding anti-HCV therapy to HAART on complexity index, adherence, and incidence of blips and (b) determine complexity index and adherence in patient subgroups based on anti-HCV therapy. METHODS: We conducted a prospective 2-center observational study. HIV/HCV coinfected patients under antiretroviral treatment who started anti-HCV bi-therapy or triple therapy between January 2011 and December 2013 were included. Patients were excluded if they were virologically uncontrolled (HIV viral load greater than 50 copies RNA/mL) or if they had changed antiretroviral treatment in the 6 months prior to the introduction of anti-HCV therapy. Data were collected before and after the addition of anti-HCV therapy to HAART. The main variables were complexity index, incidence of blips, and adherence. The complexity index was based on a score that utilized the number of pills per day, dosing schedule, dosage form, and any specific instructions linked to use of the drug. Blips were defined as a detectable HIV-RNA level ( greater than 50 copies/mL but no more than 1,000 copies/mL) occurring between 2 negative assays. Medication adherence was assessed using electronic pharmacy refill records. The threshold for optimal adherence was defined at 95% and above. Differences in the variables collected were assessed before and after the addition of anti-HCV therapy to HAART.R ESULTS: A total of 66 patients were included in the study. Based on the complexity index, the median value before and after the addition of anti-HCV therapy to HAART was 4.2 (interquartile range [IQR] = 3.5-5.5) and 11.5 (IQR = 10.4-13.4), respectively. The median difference between both complexity indices was 6.9 (95% CI = 6.9-7, P less than 0.001). After introducing the anti-HCV therapy into HAART, the number of adherent patients decreased from 50 (75.8%) to 45 (68.2%, P greater than 0.05), and 12 (18.2%) patients presented blips (P less than 0.001). Subgroup analysis based on anti-HCV therapy showed that patients on boceprevir or telaprevir therapy had a higher complexity index, 16.8 (IQR = 6.0-18.4), compared with patients on bi-therapy anti-HCV, 11.3 (IQR = 10.3-12). The median difference was 6.0 (95% CI = 5.0-7.2, P less than 0.001). The number of adherent patients decreased only in patients on bi-therapy from 42 (79.2%) to 37 (69.8%, P greater than 0.05). CONCLUSIONS: Adding anti-HCV therapy to antiretroviral treatment significantly increases treatment complexity and the incidence of blips. The introduction of anti-HCV therapy is also associated with a decrease in the number of adherent patients. The regimen complexity calculation may be useful for identifying patients who need more care from health care professionals or are at risk for failure to comply with treatment regimens.