The Cost of Psoriasis and Psoriatic Arthritis in 5 European Countries: A Systematic Review. / Coste de la psoriasis y artritis psoriásica en cinco países de Europa: una revisión sistemática.

INTRODUCTION: While the introduction of biologics has improved the quality of life of patients with psoriasis and psoriatic arthritis, it may have increased the economic burden of these diseases. OBJECTIVE: To perform a systematic review of studies on the costs associated with managing and treating psoriasis and psoriatic arthritis in 5 European countries: Germany, Spain, France, Italy, and the United Kingdom. METHODS: We undertook a systematic review of the literature (up to May 2015) using the MEDLINE and EMBASE databases. The methodological quality of the studies identified was evaluated using the Consolidated Health Economic Evaluation Reporting Standards checklist. We considered both direct costs (medical and nonmedical) and indirect costs, adjusted for country-specific inflation and converted to international dollars using purchasing power parity exchange rates for 2015 ($US PPP). RESULTS: The search retrieved 775 studies; 68.3% analyzed psoriasis and 31.7% analyzed psoriatic arthritis. The total annual cost per patient ranged from US $2,077 to US $13,132 PPP for psoriasis and from US $10,924 to US $17,050 PPP for psoriatic arthritis. Direct costs were the largest component of total expenditure in both diseases. The severity of these diseases was associated with higher costs. The introduction of biologics led to a 3-fold to 5-fold increase in direct costs, and consequently to an increase in total costs. CONCLUSIONS: We have analyzed the economic burden of psoriasis and psoriatic arthritis and shown that costs increase with the treatment and management of more severe disease and the use of biologics.

[Adherence, satisfaction and health-related quality of life in HIV-infected patients with antiretroviral therapy in Spain. The ARPAS study]. / Adherencia, satisfacción y calidad de vida relacionada con la salud en pacientes infectados por el VIH con tratamiento antirretroviral en España. Estudio ARPAS.

OBJECTIVE: To determine the relationship between satisfaction with antiretroviral therapy (ART), adherence and quality of life (QoL) in adult patients diagnosed with HIV infection and ART according to the posologic load. METHOD: Multicenter, observational and cross-sectional study. Socio-demographic, clinical and of posologic load (1, 2-4 or > 4 tablets/day), adherence (SMAQ, dispensation recordings (DR) and visual analogical scale), satisfaction (ESART questionnaire) and QoL (MOS-HIV) variables were gathered. An adherent patient was defined as the one presenting simultaneously adherence according to SMAQ and DR > 95%. RESULTS: 328 patients (76% men; 46.0 ± 9.2 years) were evaluated. The posology of 1 tablet/day, 2-4 tablets/day and > 4 tablets/day occurred in 29%, 37% and 34% of the patients, respectively. Although the evaluation performed through the SMAQ questionnaire and the VAS scale independently showed statistically significant differences in favor of the 1 tablet/day scheme, the percentage (49%) of adherent patients according to the combined variable did not differ between the groups based on the posologic load. The satisfaction with ART and QoL were high in the three groups, being the 1 tablet/day scheme the one related with higher satisfaction and lower rate of adverse effects on fat metabolism. There were no differences in patients' satisfaction by the adherence level. CONCLUSIONS: Adherence, satisfaction with ART and QoL of the patients with ART are high. Although higher in patients taking 1 tablet/day, the satisfaction did not differ according to the level of adherence and no correlation was observed between satisfaction with ART and quality of life.

OBJETIVO: Determinar la relación entre satisfacción con el tratamiento antirretroviral (TAR), adherencia y calidad de vida (CV) en pacientes adultos diagnosticados de infección por VIH con TAR según la carga posológica. MÉTODO: Estudio observacional, transversal, multicéntrico. Se recogieron variables sociodemográficas, clínicas, carga posológica (1, 2-4 o más de 4 comprimidos al día), adherencia (SMAQ, registros de dispensación (RD) y escala visual analógica), de satisfacción (cuestionario ESTAR) y de CV (MOS-HIV). Se definió paciente adherente cuando simultáneamente presentaba adherencia según SMAQ y un RD > 95%. RESULTADOS: Se evaluaron 328 pacientes (76% varones; 46,0 ± 9,2 años). El esquema de 1c/día, 2-4 c/día y > 4 c/día se dio en el 29%, 37% y 34% de los pacientes respectivamente. Pese que la evaluación realizada por el cuestionario SMAQ y la escala EVA de forma independiente muestra diferencias estadísticamente significativas a favor del esquema 1c/día, el porcentaje de pacientes adherentes según la variable combinada (49%) no difiere entre los grupos en función de la carga posológica. La satisfacción al TAR y fueron elevadas en los tres grupos, siendo los esquemas 1 c/día los relacionados con mayor satisfacción y menores efectos adversos del metabolismo de las grasas. No se observaron diferencias en la satisfacción de los pacientes según la adherencia. CONCLUSIONES: La adherencia, la satisfacción al TAR y de los pacientes con TAR es alta. La satisfacción, mayor en pacientes que toman 1 c/día, no difiere en función de la adherencia y no se observó correlación entre satisfacción con el TAR y calidad de vida.

[Development and validation of a prediction model to identify HIV+ patients with drug-related problems. A prediction study]. / Desarrollo y validación de un modelo predictivo para la identificación de pacientes infectados por el VIH con problemas relacionados con los medicamentos. Estudio predictor.

OBJECTIVE: To develop and validate a prediction model for the detection of drug-related problems (DRP) in patients on antiretroviral treatment during their regular monitoring in Pharmaceutical Care Clinics before dispensing drugs. MEHOD: Open multicentre prospective study. HIV patients with and without DRP were included. Demographic, clinical and pharmacotherapy variables (related and unrelated to antiretroviral treatment) were included in the model design. To find prognostic factors for DRP, a binary logistic regression model was created after performing a univariate analysis that identified independent variables related to DRP these variables were introduced in the multivariate model for the final selection. Model validity was determined by the shrinkage method and the discriminatory power by Harrell's C-index. RESULTS: 733 patients were included. The variables "adherence", "prescription of drugs needing dosage adjustment", and "total number of drugs prescribed (apart from the antiretroviral treatment)" were independently related to the appearance of DRP. Probabilities predicted by the model, customising the coefficients using the uniform shrinkage method, showed a R(2)=0.962 for the construction sample and a R(2)=0.872 for the validation sample. The discriminatory capacity of the model was 0.816 for the construction sample and 0.779 for the validation sample. CONCLUSIONS: The developed and validated model enables detection of patients on antiretroviral treatment who are at a higher risk for experiencing a DRP. The prediction variables employed are commonly used in patient's pharmacotherapy record, allowing the model to be used in routine clinical practice.

[Costs and adherence to antiretroviral treatment]. / Costes y adherencia del tratamiento antirretroviral.

OBJECTIVE: To develop a system of data management that allows us to estimate the comparative effectiveness of the various antiretroviral treatment (ART) regimens. METHOD: Retrospective observational study in patients infected with HIV with stable ART. Adherence to treatment and unit cost for each patient's treatment was determined. The cost/patient/day was calculated and, multiplying by an adherence factor (fADH), the (cost/patient/day)(ADH). The comparison of both allowed us to obtain the Δcost/patient, which estimates the additional costs caused by lack of adherence. The incremental cost-effectiveness (iCER), grouping the results by the various coformulated drugs ("combos"). A study of the budgetary impact of these combos was carried out. RESULTS: 468 patients were evaluated (62% adherent). Average adherence was 88±18%. The average value of (cost/patient/day) (ADH) was significantly higher than the cost/patient/day (27.3±9.8€ compared to 24.3±7.6€. p<0.001). Just as with the f(ADH), no differences were found in the Δcost/patient between the different ART combinations. The combo with the least deviation from the cost/patient/day due to lack of adherence was that composed of abacavir/zedovudine/lamivudine (ABC/AZT/3TC,Δcost/patient=8.72±14.18%), and that with the greatest deviation AZT/3TC (Δcost/patient=13.52±17.68%). No significant differences were found in the iCER calculated for any combo. The ART that included abacavir/lamivudine (ABC/3TC) obtained the least budgetary impact. CONCLUSIONS: The greatest cost and percentage of adherent patients associated with the combos composed of Tenovovir/Emtricitabine(TDF/FTC) and ABC/3TC, and the least cost and effectiveness of those composed of AZT/#TC and ABC/AZT/3TC, does not allow us to identify any option as significantly dominant. The regimens with ABC/3TC were shown to be the most favourable from the combined point of view of cost and adherence.

[The pharmacokinetics of metronidazole and gentamicin in a single preoperative dose as antibiotic prophylaxis in colorectal surgery]. / Farmacocinética del metronidazol y la gentamicina en dosis única preoperatoria para profilaxis antibiótica quirúrgica en cirugía colorrectal.

OBJECTIVE: To describe, in patients undergoing colorectal surgery (CRS), the pharmacokinetics of a single, prophylactic preoperative dose of 1,500 mg of metronidazole plus 240 mg gentamicin and measure its efficacy in accordance with the accepted pharmacodynamic and microbiological parameters. METHOD: Thirty-six patients undergoing CRS agreed to participate in the study. Three blood samples were taken from each. Cmax 15 minutes after finishing the infusion of the mixture, CfinIQ on finishing the surgery, and Cmin between 12 and 24 hours post-administration. The concentrations of metronidazole and gentamicin in each simple were measured and the pharmacokinetic parameters were estimated (dV- distribution volume , Cl-plasma clearance). For the metronidazole, concentrations in excess of 8 microg/ml were considered effective, and for gentamicin, C(max) in excess of 9 microg/ml and inhibition quotients above 8. RESULTS: All the concentrations of metronidazole, both CmaxMTZ and CfinIQMTZ were above 8 microg/ml and all the CmaxGEN in excess of 9 microg/ml. The CIGEN was 13.8+/-3.8, with no individual value below 8. For the metronidazole, a dV of 0.68+/-0.2 l/kg was estimated and a Cl of 3.15+/-1.20 l/h and for the gentamicin, the dV as 0.23+/-0.06 l/kg and the Cl was 4.71+/-1.95 l/h. CONCLUSION: In patients undergoing CRS, surgical intervention did not significantly modify the pharmacokinetics of metronidazole or gentamicin in comparison with other groups of patients. The prophylaxis using a single, pre-surgical dose enables the achievement, for both antimicrobial agents, concentrations of a sufficient size to guarantee clinical efficacy.

[Psychometric characteristics of the antiretroviral treatment satisfaction scale (ESTAR): ARPAS study (I)]. / Características psicométricas de la escala de satisfacción con el tratamiento antirretroviral (ESTAR): estudio ARPAS (I).

OBJECTIVE: To evaluate the psychometric characteristics, convergent validity and reliability of the antiretroviral treatment satisfaction scale (ESTAR, escala de satisfacción con el tratamiento antirretroviral). METHOD: Patient satisfaction with ART was determined using the ESTAR questionnaire, developed in Spanish based on the English language version of the HIV-Treatment-Satisfaction Questionnaire (HIVTSQ). In order to evaluate this, internal consistency and test-retest reliability were measured. The construct analysis was performed by studying the covariance and correlation of the questions, and the convergent validity was assessed by using the MOS-HIV (Medical Outcomes Study HIV Health Survey) questionnaire as the standard, as was the content validity by the correlation between the ESTAR and the clinical and therapeutic variables. RESULTS: The ESTAR is structured in two dimensions (clinical satisfaction and satisfaction with lifestyle) with slight modifications to the original version; question 4, discarded in the original version, has been reworded in the Spanish version, and question 9 was deleted because of low communality. As regards the test-retest reliability, all the questions show significant intraclass correlation coefficients (p<0.001). The internal consistency shows higher values than the original version in the lifestyle dimension (a=0.81 vs. a=0.74) and in the total score (a=0.84 vs. a=0.82). With regard to convergent validity, the ESTAR presents significant correlations with the MOS-HIV as a whole and with different dimensions of it, especially the association with mental health, health distress and cognitive functioning dimensions. CONCLUSIONS: The ESTAR turns out to be a suitable, reliable instrument for evaluating satisfaction with ART by HIV+ patients.

[Preferences, satisfaction and compliance with antiretroviral treatment: ARPAS study (II)]. / Preferencias, satisfacción y adherencia con el tratamiento antirretroviral: estudio ARPAS (II).

OBJECTIVE: To describe the ARPAS study and analyse the sociodemographic and clinical characteristics and patient preferences with regards the antiretroviral treatment (ART), as well as the relationship between compliance and satisfaction with the ART and quality of life. METHOD: The ARPAS study has looked at adult patients diagnosed with HIV and on ART, using a protocol including sociodemographic, clinical, therapeutic and quality of life variables. Compliance was estimated using the SMAQ questionnaire; satisfaction was measured using the ESTAR questionnaire, as was quality of life with the MOS-HIV Health Survey, and treatment preferences were determined using a questionnaire prepared based on the consensus of an expert team in the field of therapeutic monitoring of these patients. A stratified univariate analysis according to compliance and a logistic regression analysis were carried out to study the association of the independent variables with compliance. RESULTS: A total of 234 patients were evaluated (73.7% male; 43.2+/-7.8 years of age). The average time since diagnosis and from the initiation of ART was 10.1+/-5.7 and 7.4+/-4.4 years respectively. The therapeutic regime of twice-daily doses (bid) was applied to 71% of the patients, and once daily (qd) in 21%. A total of 43% of the patients fulfilled compliance criteria according to the SMAQ. The percentage of the patients with qd complying with the ART was greater than the remaining dosing schedules (55.3 vs. 45.1%), although not significantly (p=0.251). No differences were observed in the sociodemographic and clinical variables in terms of compliance. An elective preference was observed for the simplest of the therapeutic regimes which contrasts with the evaluation of the ART characteristics, where power is given preference over durability, tolerance and lastly, the convenience of taking the ART. The univariate analysis showed the highest score on the satisfaction scales (50.4+/-7.8 vs. 46.5+/-9.7, p=0.001) and quality of life (81.6+/-10.7 vs. 75.7+/-11.8, p<0.001) in compliant patients with respect to non-compliers. The multivariate models confirm the existence of a significant association between compliance and satisfaction, and between compliance and quality of life. CONCLUSIONS: Patients consider treatment with a powerful, long-lasting and well-tolerated ART a priority and among their preferences for different treatment regimes, once-daily dosing regimes are highlighted. The ARPAS study showed a direct relationship between compliance and satisfaction with ART, and between compliance and quality of life, in a manner that the strategies improving compliance must necessarily include aspects that allow them to improve patient satisfaction with treatment and quality of life.

[Simplified scale for medication adherence related problems in anti-retroviral therapy]. / Escala simplificada para detectar problemas de adherencia (ESPA) al tratamiento antirretroviral.

OBJECTIVE: The purpose is to describe an own-developed scale for medication adherence evaluation of HIV patients under antiretroviral therapy, and to compare it with other previously described methods. METHODS: The six-item scale was compared with a pharmacy record about the delivery of medication. Accordance between scale and a four-item Morisky-type scale (measure 1) and a percentage of doses taken as prescribed during the past two weeks (measure 2) was computed. RESULTS: The own-scale showed 93% sensitivity, 70% specificity, a likelihood ratio of 3.08 and good agreement compared with the pharmacy record (k = 0.62, p < 0.001). Agreement between the scale and measure 1 and measure 2 was very weak (k = 0.12, p = 0.446 and k = 0.10, p = 0.273 respectively). 39.7% of patients was considered as adherent according with the own-scale and was observed correlation between adherence and clinical outcomes. CONCLUSION: The scale appears to be a valid instrument to check and detect adherence related problems compared with the pharmacy medication record. Easiness to use make feasible to consider as an adequate tool to detect non-adherent patients or patients with adherence related problems into the daily clinical practice.

[HIV-infected patients' perceived satisfaction with an outpatient pharmaceutical care unit (OPCU)]. / Originales Breves Satisfacción percibida por pacientes infectados por el VIH con la unidad de atención farmacéutica a pacientes externos (UFPE).

INTRODUCTION: Satisfaction measurements attempt to establish patient views regarding health care. In the setting of pharmaceutical care, the measurements of the generically called "h umanistic"variables is scarce, and the number of validated instruments is inadequate. The goal of this study is to present a specifically-developed satisfaction survey regarding outpatient pharmaceutical care units, and to prove its applicability and inner consistency in a HIV-infected patient population on antiretroviral therapy. METHODS: The survey includes 19 questions within four groups - A. The unit's physical space, location, and organization; B. Dispensation; C. Pharmaceutical consultation, and D. Overall satisfaction with the unit. Each question is scored from 1 to 5. The study was carried out by administering 250 surveys to consecutive patients arriving at the OPCU, Castell6n General Hospital. RESULTS: Responses show a high degree of patient satisfaction with questions posed, with mean values oscillating between 3.0 and 4.8. The highest means corresponded to pharmacist valuation, and the lowest values corresponded to questions within the organizational module. All questions considered, the mean score obtained was 3.96 + 0.95 (median of 4). The survey exhibited high internal reproducibility both for each group and all questions. CONCLUSION: The satisfaction survey discussed here is an accessible, easy-to-use instrument that may be rapidly completed and used in pharmaceutical care units with outpatients as a measurement of patient satisfaction. The high scores HIV-infected patients assign to questions included in the survey suggest a benefit from standardized pharmaceutical care.

[Pharmaceutical care program in HIV patients under antiretroviral treatment: methodology and documentation]. / Programa de atención farmacéutica a pacientes VIH con tratamiento antirretroviral: metodología y documentación.

Most hospital pharmacy services in Spain have increased pharmaceutical care activities for HIV-patients under antiretroviral therapy during last years. So, it is necessary the establishment of work methods to secure the best quality of care. The pharmacy service of the general hospital of Castellón has developed a global pharmaceutical care program for these patients characterized by the systematic and individualized strategy or basic pharmaceutical care record which can be completed with additional proceedings. The basic record includes complete drug therapy registry, clinical evolution data and detection of drug related problems (DRP), evaluation and promotion of patient adherence, individualized counselling and nutritional evaluation. Additional proceedings include exhaustive DRP monitoring, additional patient adherence to treatments measurements, SOAP methodology, quality of life and perceived patient satisfaction. Our purpose integrate patient status with pharmaceutical care provided and the expected or obtained outcomes, either clinical or economic as well as activity outcomes, quality of life and satisfaction related results. The main characteristics of the purposed methodology are: clinical orientation, it permits the registry and the establishment of a systematic work methodology, is designed as a cross structure and variables are coded. According to our experience, our model can be considered useful in clinical practice and could be applied in different hospital outpatient units.