Disease burden and costs for patients with hip and knee osteoarthritis and chronic moderate-to-severe refractory pain on treatment with strong opioids in Spain.

INTRODUCTION AND OBJECTIVES: To determine the disease burden and costs in patients with hip or knee OA and chronic moderate-to-severe refractory pain, receiving strong opioids in Spain. MATERIALS AND METHODS: This was a 36-month longitudinal secondary analysis of the real-word OPIOIDS study. Patients aged ≥18 years with hip or knee OA and chronic moderate-to-severe refractory pain receiving strong opioids were considered. The disease burden included analgesia assessments (NRS scale), cognitive functioning (MMSE scale), basic activities of daily living (Barthel index), and comorbidities (severity and frequency). Costs due to the use of healthcare resources and productivity loss were estimated. RESULTS: 2832 patients were analyzed; age was 72.0 years (SD=14.3), 76.8% were women. Patients had mainly been treated with fentanyl (n=979; 37.6%), tapentadol (n=625; 24.0%), oxycodone (n=572; 22.0%), and buprenorphine (n=425; 16.3%). Pain intensity decreased by 1 point (13.7%), with a 2.6-point decline in the cognitive scale (14.3%, with a 5.3%-increase in patients with cognitive deficit) over a mean treatment period of 384.6 days (SD: 378.8). Barthel scores decreased significantly yielding to a slightly increase in proportion of patients with severe-to-total dependency; 1.2%-2.9%. In the first year of treatment, average healthcare costs were €2013/patient, whereas the average productivity loss cost was €12,227/working-active patient. DISCUSSION AND CONCLUSIONS: Strong opioids resulted in high healthcare costs with a limited reduction in pain, an increase in cognitive deficit, and a slight increase of patients with severe to total dependency over 36 months of treatment.

Disease burden and costs for patients with hip and knee osteoarthritis and chronic moderate-to-severe refractory pain on treatment with strong opioids in Spain / Carga de la enfermedad y costes en pacientes con osteoartritis de cadera y rodilla con dolor crónico refractario moderado-severo tratados con opioides mayores en España

Introduction and objectives: To determine the disease burden and costs in patients with hip or knee OA and chronic moderate-to-severe refractory pain, receiving strong opioids in Spain. Materials and methods: This was a 36-month longitudinal secondary analysis of the real-word OPIOIDS study. Patients aged ≥18 years with hip or knee OA and chronic moderate-to-severe refractory pain receiving strong opioids were considered. The disease burden included analgesia assessments (NRS scale), cognitive functioning (MMSE scale), basic activities of daily living (Barthel index), and comorbidities (severity and frequency). Costs due to the use of healthcare resources and productivity loss were estimated. Results: 2832 patients were analyzed; age was 72.0 years (SD=14.3), 76.8% were women. Patients had mainly been treated with fentanyl (n=979; 37.6%), tapentadol (n=625; 24.0%), oxycodone (n=572; 22.0%), and buprenorphine (n=425; 16.3%). Pain intensity decreased by 1 point (13.7%), with a 2.6-point decline in the cognitive scale (14.3%, with a 5.3%-increase in patients with cognitive deficit) over a mean treatment period of 384.6 days (SD: 378.8). Barthel scores decreased significantly yielding to a slightly increase in proportion of patients with severe-to-total dependency; 1.2%–2.9%. In the first year of treatment, average healthcare costs were €2013/patient, whereas the average productivity loss cost was €12,227/working-active patient. Discussion and conclusions: Strong opioids resulted in high healthcare costs with a limited reduction in pain, an increase in cognitive deficit, and a slight increase of patients with severe to total dependency over 36 months of treatment.(AU)

Introducción y objetivos: Determinar la carga de la enfermedad y los costes en pacientes con osteoartritis de cadera y rodilla y dolor crónico refractario moderado-severo, en tratamiento con opioides mayores en España. Materiales y métodos: Se trata de un subanálisis de 36 meses de duración, procedente del estudio observacional OPIOIDS. Participaron pacientes con una edad ≥18 años, diagnosticados con osteoartritis de cadera y rodilla y dolor crónico refractario moderado-severo, en tratamiento con opioides mayores. La carga de la enfermedad incluyó la evaluación de la analgesia (escala NRS), del funcionamiento cognitivo (escala MMSE), de la capacidad para realizar las actividades de la vida diaria (índice de Barthel) y de las comorbilidades (gravedad y frecuencia). También se estimaron los costes asociados al uso de recursos sanitarios y a la productividad laboral. Resultados: Se analizaron 2.832 pacientes (edad: 72,0 años [DE: 14,3]; mujeres: 76,8%), que habían sido principalmente tratados con fentanilo (n=979; 37,6%), tapentadol (n=625; 24,0%), oxicodona (n=572; 22,0%) y buprenorfina (n=425; 16,3%). La intensidad del dolor disminuyó una unidad (13,7%), con una reducción de 2,6 unidades en la escala cognitiva (14,3% y aumento del 5,3% en los pacientes con déficit cognitivo) durante una media de 384,6 días (DE: 378,8). Las puntuaciones en la escala de Barthel disminuyeron significativamente, con un ligero aumento en la proporción de pacientes con dependencia grave/total, entre 1,2% y 2,9%. En el primer año, los costes sanitarios medios fueron 2.013€/paciente, mientras que los costes medios de pérdida de productividad fueron 12.227€/trabajador. Discusión y conclusiones: El tratamiento con opioides mayores durante 36 meses implicó elevados costes sanitarios, con una eficacia analgésica limitada, un aumento del déficit cognitivo y un ligero aumento de los pacientes con dependencia grave/total.(AU)

Sick Leave and Costs in Active Workers with Chronic Osteoarthritis Pain in Spain: Outcomes of the OPIOIDS Real World Study.

Purpose: To estimate the number of sick leave days and productivity costs in active workers with osteoarthritis (OA) who initiated opioid treatment for moderate/severe chronic pain in clinical practice in Spain. Patients and Methods: This is a secondary analysis of the longitudinal, retrospective OPIOIDS study, using electronic medical records (EMR) of patients aged ≥18 years, who started an opioid treatment for moderate/severe chronic OA pain between 2010 and 2015 after treatment failure with ≥1 first-line drugs (acetaminophen, metamizole and/or nonsteroidal anti-inflammatory drugs [NSAIDs]). The number of days of sick leave and productivity costs were analyzed during a follow-up period of 36 months. Results: A total of 5089 patients with moderate/severe chronic OA pain, aged 56.8 years (standard deviation [SD]: 4.6) (56.6% were female), were analyzed: 73.3% of them started a treatment with weak opioids and 26.7% of them were treated with strong opioids. At 36 months, adherence was 21.0% (strong opioids: 15.4%; weak opioids: 23.0%; p<0.001), and 77% of patients had at least one sick leave related with chronic OA pain, with an average of 93 days off work in all working patients (120.5 days in patients with sick leaves). Besides, 16.9% of the study population had sick leave periods that lasted at least 6 months. Pain reduction was modest (-1.2 points; -4.0%, p<0.001). The cost of sick leave was €2594 patient/year, and factors such as older age (ß=0.043), female sex (ß=0.036), comorbidities (ß=0.035) and strong opioid use (ß=0.031) were associated with higher productivity costs (p<0.05 in all associations). Conclusion: Active workers who started opioid treatment for moderate/severe chronic OA pain showed an increased frequency of sick leave and productivity cost, with a modest effect on pain relief. Older age, female sex, comorbidities, and strong opioids were associated with higher costs for society.

Disease Burden and Costs in Moderate-to-Severe Chronic Osteoarthritis Pain Refractory to Standard of Care: Ancillary Analysis of the OPIOIDS Real-World Study.

INTRODUCTION: To determine the disease burden and costs in moderate-to-severe chronic osteoarthritis (OA) pain refractory to standard-of-care treatment in the Spanish National Health System (NHS). METHODS: Ancillary analysis of the OPIOIDS real-world, non-interventional, retrospective, 4-year longitudinal study including patients aged at least 18 years with moderate-to-severe chronic OA pain refractory to standard-of-care with sequential NSAIDs plus opioids. Burden assessment included measurement of analgesia, cognitive functioning, basic activities of daily living, severity and frequency of comorbidities, and all-cause mortality. Costs accounted for healthcare resource utilization and related costs (year 2018). RESULTS: Records of 13,317 patients were analyzed; 68.9 (14.7) years old, 71.3% (70.5-72.1%) women, 58.1% refractory to NSAID plus weak opioid and 41.9% to NSAID plus strong opioid, accounting for 10.7% (10.5-10.8%) of patients with chronic OA pain. Mean number of comorbidities was 2.9 (1.8) and its severity was 1.8 (1.7). Pain decreased by 0.9 points (12.2%) and cognitive declined by 2.3 points (9.1%, with 4.3% more patients with cognitive deficit) and dependency worsened by 0.4 points (0.5%, with 2.3% more patients with severe-to-total dependence) over a mean treatment period of 188.6 (185.4-191.8) days on NSAIDs followed by 400.6 (393.7-407.5) days on opioids. The adjusted mortality rate was higher in patients with OA taking NSAID plus strong opioids; hazard ratio 1.44 (1.26-1.65; p < 0.001). The 4-year healthcare cost was €7350/patient (€7193-7507 or €1838/year) and was higher in those taking strong versus weak opioids; €9886 (€9608-10,164, €2472/year) vs. €5519 (€5349-5689, €1380/year), p < 0.001. Analgesia cost (16.0% of total cost, 70.2% opioids) was higher with strong versus weak opioids, 19.6% vs. 11.3%, p < 0.001. CONCLUSIONS: In routine clinical practice in Spain, patients with moderate-to-severe chronic OA pain refractory to standard analgesic treatment with NSAIDs plus opioids reported modest reductions in pain, while presenting a considerable burden of comorbidities, cognitive impairment, and dependency. Healthcare costs significantly increased for the NHS particularly with NSAIDs plus strong opioids.

Health outcomes and costs in patients with osteoarthritis and chronic pain treated with opioids in Spain: the OPIOIDS real-world study.

OBJECTIVE: The objective of this study was to analyze health outcomes, resource utilization, and costs in osteoarthritis patients with chronic nociceptive pain who began treatment with an opioid in real-world practice in Spain. METHODS: We designed a non-interventional, retrospective, longitudinal study with 36 months of follow-up using electronic medical records (EMRs) from primary care centers, of patients aged 18+ years who began a new treatment with an opioid drug in usual practice for chronic pain due to osteoarthritis. Health/non-health resource utilization and costs, treatment adherence, pain change, cognitive functioning, and dependence for basic activities of daily living (BADL) were assessed. RESULTS: A total of 38,539 EMRs [mean age (SD); 70.8 (14.3) years, 72.3% female; 53.3% hip/knee, 25.0% spine, and 21.7% other sites] were recruited. A total of 19.1% of patients remained on initial opioid at 36 months, without significant differences by osteoarthritis site (p = 0.125). Mean total adjusted cost was €17,915, with 27.7% corresponding to healthcare resources and 72.3% to lost productivity. Hospital admissions for osteoarthritis-related surgical interventions accounted for 15.8% of total healthcare cost. A slight mean pain reduction was observed: -1.3 points, -16.9%, p < 0.001, with increases in cognitive deficit (+3.3%, p < 0.001) and moderate to total dependence for BADL (+15.6%, p < 0.001) in a median duration of opioid use of 203 days (IQR: 89-696). CONCLUSIONS: In real-world practice in Spain, opioid use in osteoarthritis was high, but with low adherence. There were meaningful increases in resource use and costs for the National Health System. Pain reduction was modest, whereas cognitive impairment and dependence for BADL increased significantly.

Perfil del paciente con vejiga hiperactiva tratado con dosis flexible de antimuscarínicos en la práctica clínica diaria / Profile of oab patient on treatment with flexible-dose antimuscarinic drugs in daily clinical practice

OBJETIVO: Describir en el entorno de la práctica clínica diaria, el perfil del paciente con vejiga hiperactiva (VH) tratado con dosis flexible de antimuscarícos. MÉTODOS: Estudio observacional, retrospectivo y multicéntrico llevado a cabo en 88 Hospitales públicos y privados. Se incluyeron pacientes adultos, diagnosticados de VH que iniciaron tratamiento con algún antimuscarínico a dosis flexible. Se recogió tipo de antimuscarínico, dosis, tratamientos concomitantes, beneficio aportado y cumplimiento terapéutico. RESULTADOS: Población constituida por 846 pacientes mayores de 60 años, pluripatológica (83,5%) y polimedicada (73,4%), formada mayoritariamente por mujeres (74,5%) y con más de un año de evolución de la VH. Principales antimuscarínicos inicialmente prescritos: fesoterodina (66,9%) y solifenacina (31,0%). El 68,2% de los pacientes iniciaron el tratamiento con la dosis baja. En la visita de seguimiento, el 47,0% modificó dosis (84,2% aumentaron la dosis, 15,8% disminuyeron la dosis). Los grupos que tuvieron que modificar dosis presentaron significativamente mayor morbilidad, peor sintomatología, mayor empleo de recursos sanitarios y peor cumplimiento terapéutico que el grupo de pacientes tratados siempre a dosis alta. CONCLUSIÓN: En determinados pacientes, el empleo desde el inicio del tratamiento antimuscarínico de dosis- flexible a la dosis más alta, podría proporcionar mayor beneficio terapéutico, adherencia y menor empleo de recursos sanitarios que el escalado de dosis

OBJECTIVE: To describe the profile of the overactive bladder (OAB) patient on treatment with flexible-dose antimuscarinic treatment in daily clinical practice. METHODS: This was an observational, retrospective and multicenter study, carried out at 88 public and private hospitals. Adult patients diagnosed with OAB who initiated flexible-dose antimuscarinic treatment. Type of antimuscarinic, dose, concomitant treatments, treatment benefit and treatment adherence were recorded. RESULTS: This was a pluripathological (83.5%) and polymedicated (73.4%) population, comprised of 846 patients, mostly women (74.5%) with a mean (SD) age of 61.3 (12.1) years and more than one year of OAB evolution. Main initially prescribed antimuscarinics were fesoterodine (66.5%) and solifenacine (30.0%). Overall, 68.2% of the patients started treatment with the low dosage; at the follow-up visit 47.0% changed the dosage (84.2% increased the dosage, 15.8% decreased the dosage). Patients who changed the dosage showed a significantly greater morbidity, worse OAB symptoms, greater health resources use, and worse adherence to treatment compared with those that maintained the high dosage all the time. CONCLUSION: No differences were found regarding the demographic or clinical characteristics that allow us to identify which patients should receive the different options of available dose of antimuscarinic drugs, although greater benefits seem to be achieved with the use of the highest or the lowest dose from the outset than with the change of dose

Profile of oab patient on treatment with flexible-dose antimuscarinic drugs in daily clinical practice. / Perfil del paciente con vejiga hiperactiva tratado con dosis flexible de antimuscarínicos en la práctica clínica diaria.

OBJECTIVE: To describe the profile of the overactive bladder (OAB) patient on treatment with flexible-dose antimuscarinic treatment in daily clinical practice. METHODS: This was an observational, retrospective and multicenter study, carried out at 88 public and private hospitals. Adult patients diagnosed with OAB who initiated flexible-dose antimuscarinic treatment. Type of antimuscarinic, dose, concomitant treatments, treatment benefit and treatment adherence were recorded. RESULTS: This was a pluripathological (83.5% and polymedicated 73.4%) population, comprised of 846 patients, mostly women (74.5%) with a mean (SD) age of 61.3 (12.1) years and more than one year of OAB evolution. Main initially prescribed antimuscarinics were fesoterodine (66.5%) and solifenacine (30.0%). Overall, 68.2% of the patients started treatment with the low dosage; at the follow-up visit 47.0% changed the dosage (84.2% increased the dosage, 15.8% decreased the dosage). Patients who changed the dosage showed a significantly greater morbidity, worse OAB symptoms, greater health resources use, and worse adherence to treatment compared with those that maintained the high dosage all the time. CONCLUSION: No differences were found regarding the demographic or clinical characteristics that allow us to identify which patients should receive the different options of available dose of antimuscarinic drugs, although greater benefits seem to be achieved with the use of the highest or the lowest dose from the outset than with the change of dose.

Validación psicométrica de las escalas OAB-V8 y OAB-V3 para la detección de pacientes con probable vejiga hiperactiva en la población española / Psychometric validation of the OAB-V8 and OAB-V3 scales for the screening of patients with probable overactive bladder in the Spanish population

Fundamento y objetivo: Realizar la validación psicométrica en la población española de la escala Overactive Bladder Awareness Tool (OAB-V8), y de su versión abreviada, OAB-V3, para la detección de pacientes con probable vejiga hiperactiva (VH). Pacientes y método: Estudio transversal en población general > 18 años realizado por vía telemática (Internet) sobre una población representativa de la prevalencia de VH en la población española. Las propiedades evaluadas incluyeron factibilidad, fiabilidad y validez. Los sujetos incluidos fueron clasificados según la probabilidad de VH usando un algoritmo automatizado validado previamente. Se realizó análisis de curvas ROC y se determinaron sensibilidad, especificidad, y valores predictivos positivo y negativo. Resultados: Se incluyeron 2.035 sujetos, con una edad media + DE de 52,7 + 12,1 años (50,8% varones). El 13,7% fue clasificado como «Probable»; el 27,9% como «Posible» y el 58,3% como «No» VH. La consistencia interna para las escalas OAB-V8 y OAB-V3 fue alta (0,894 y 0,851 respectivamente), con correlaciones ítem-total asimismo elevadas en ambos casos (0,87-0,88 y 0,71-0,83 respectivamente). Ambas escalas fueron fiables con coeficientes de correlación intraclase de 0,826 (intervalo de confianza del 95%: 0,695-0,901) y 0,828 (intervalo de confianza del 95%: 0,623-0,922), respectivamente. El punto de corte óptimo en la escala OAB-V8 para identificar probable VH fue ≥ 8 puntos (área bajo la curva 0,895; sensibilidad 0,875 y especificidad 0,735), mientras que en la OAB-V3 fue ≥ 3 (área bajo la curva 0,910, sensibilidad 0,828 y especificidad 0,825). Conclusión: Las escalas OAB-V8 y OAB-V3 resultaron ser herramientas útiles de cribado autoadministrado por vía telemática, factibles, fiables y válidas para la detección de pacientes con probable VH en la población general en España (AU)

Background and objective: To perform the psychometric validation in the Spanish population of the Overactive Bladder Awareness Tool (OAB-V8) scale and its abbreviated version OAB-V3 for screening patients with probable overactive bladder (OAB). Patients and methods: A cross-sectional study was conducted in a population aged over 18 years, which was representative of the prevalence of OAB in Spain using an online methodology (Internet survey). Psychometric properties included feasibility, reliability, and validity. Subjects were classified according to the likelihood of OAB, using an automated algorithm validated previously. ROC curve analysis was performed, and the sensitivity, specificity, and positive and negative predictive values were also assessed. Results: A total of 2,035 subjects with a mean + SD age of 52.7 + 12.1 years were included (50.8%) men. In total 13.7% were classified as «Probable», 27.9% «Possible», and 58.3% «No» OAB. The internal consistency of both OAB-V8 and OAB-V3 scales was high (0.894 and 0.851, respectively). The item-total correlation coefficients were high; 0.87-0.88 and 0.71-0.83, respectively. Intraclass correlation coefficient for OAB-V8 was 0.826 (confidence interval 95% 0.695-0.901) and it was 0.828 (confidence interval 0.623-0.922) for OAB-V3. The optimum cut-off value of OAB-V8 for detecting probable OAB was ≥ 8 points (AUC = 0.895, sensitivity 0.875, specificity 0.735), while for the OAB-V3 it was ≥ 3 (AUC = 0.910, sensitivity 0.828, specificity 0.825). Conclusion: Both OAB-V8 and OAB-V3 scales were considered useful online self-administered screening tools, which were also feasible, reliable and valid for the detection of patients with probable OAB in the general population in Spain (AU)

[Psychometric validation of the OAB-V8 and OAB-V3 scales for the screening of patients with probable overactive bladder in the Spanish population]. / Validación psicométrica de las escalas OAB-V8 y OAB-V3 para la detección de pacientes con probable vejiga hiperactiva en la población española.

BACKGROUND AND OBJECTIVE: To perform the psychometric validation in the Spanish population of the Overactive Bladder Awareness Tool (OAB-V8) scale and its abbreviated version OAB-V3 for screening patients with probable overactive bladder (OAB). PATIENTS AND METHODS: A cross-sectional study was conducted in a population aged over 18 years, which was representative of the prevalence of OAB in Spain using an online methodology (Internet survey). Psychometric properties included feasibility, reliability, and validity. Subjects were classified according to the likelihood of OAB, using an automated algorithm validated previously. ROC curve analysis was performed, and the sensitivity, specificity, and positive and negative predictive values were also assessed. RESULTS: A total of 2,035 subjects with a mean+SD age of 52.7+12.1 years were included (50.8%) men. In total 13.7% were classified as «Probable¼, 27.9% «Possible¼, and 58.3% «No¼ OAB. The internal consistency of both OAB-V8 and OAB-V3 scales was high (0.894 and 0.851, respectively). The item-total correlation coefficients were high; 0.87-0.88 and 0.71-0.83, respectively. Intraclass correlation coefficient for OAB-V8 was 0.826 (confidence interval 95% 0.695-0.901) and it was 0.828 (confidence interval 0.623-0.922) for OAB-V3. The optimum cut-off value of OAB-V8 for detecting probable OAB was≥8 points (AUC=0.895, sensitivity 0.875, specificity 0.735), while for the OAB-V3 it was ≥ 3 (AUC=0.910, sensitivity 0.828, specificity 0.825). CONCLUSION: Both OAB-V8 and OAB-V3 scales were considered useful online self-administered screening tools, which were also feasible, reliable and valid for the detection of patients with probable OAB in the general population in Spain.

Predicting self-perceived antimuscarinic therapy effectiveness on overactive bladder symptoms using the Overactive Bladder 8-Question Awareness Tool.

INTRODUCTION AND HYPOTHESIS: This work was designed to explore the ability of the self-administered Overactive Bladder 8-Question Awareness Tool (OAB-V8) to predict patient self-assessed effectiveness of antimuscarinic therapy on OAB symptoms in daily practice. Also, the ability of the tool to predict clinician evaluation of improvement was explored. METHODS: Patients of both genders, >18 years, with symptomatic OAB (score >8 on OAB-V8), and able to understand patient-reported outcome instruments were enrolled in this 3-month study. Patients were prescribed treatment with an antimuscarinic drug according to usual practice. Treatment effectiveness was assessed by the clinician and patient using the Clinical Global Impression of Improvement and Treatment Benefit Scale and by improved self-perceived quality of life using the Overactive Bladder Questionnaire Short Form (OAB-q SF) 3 months after initiating or changing an antimuscarinic therapy. Multivariate linear and logistic regression models were applied to explore the predictive validity of OAB-V8 scores at the baseline visit. RESULTS: A total of 246 patients (57.7 years, 67 % women) were analyzed. Based on baseline OAB-V8 scores, logistic regression models were capable of predicting clinical improvement and patient self-perceived treatment benefit in 70 % of cases. OAB-V8 scores significantly correlated with OAB-q SF domains at baseline: 0.790 and - 0.659 for symptom bother and health-related quality of life domains, respectively (p < 0.001 in both cases). Baseline OAB-V8 score was able to predict changes in both domains of the OAB-q SF: R (2) = 0.212 and 0.162 for symptom bother and health-related quality of life, respectively. CONCLUSIONS: The OAB-V8 scale showed evidence of predictive validity for antimuscarinic effectiveness in daily practice based on physician assessment and patient self-assessment of improved quality of life and treatment benefit.

[Cancer Survival between 1995 and 2004 in the Basque Country, Spain].

BACKGROUND: geographic differences described in the prognosis of cancer patients in the Basque Country have been attributed to a different incidence in tumours with different lethality. Therefore, cancer relative survival adjusted by case-mix was included to estimate cancer survival by provinces and health regions, using data from 1995 to 2004. METHODS: a total of 93 585 cases of malignant tumours were identified from a population-based cancer registry. The five-year relative survival (RS) was calculated using Ederer´s method. The five-year relative excess risk (RER) of death was estimated with a generalised linear model, standardized by age and adjusted for sex, date of diagnosis and case-mix. RESULTS: the five-year RS increased from period 1995-1999 to 2000-2004, this latter, with values ranging by health regions between 46-58% and 57-65% in men and women, respectively. There was an excess risk of death in Bizkaia (RER=1.06, CI95%: 1.03-1.09), this same effect being identified in almost all the health regions in the province. In contrast, in Gipuzkoa province, differences were only statistically significant in the Gipuzkoa and Tolosa health regions (RER=1.07; CI95%: 1.02-1.13 and RER=0.91; CI95%: 0.84-0.98, respectively), and even these disappeared after adjusting for potential confounders. CONCLUSIONS: cancer patients of Bizkaia, except for the Uribe health region, presented a worse prognosis.

Dose and aging effect on patients reported treatment benefit switching from the first overactive bladder therapy with tolterodine ER to fesoterodine: post-hoc analysis from an observational and retrospective study.

BACKGROUND: Previous randomized studies have demonstrated that fesoterodine significantly improves the Overactive Bladder (OAB) symptoms and their assessment by patients compared with tolterodine extended-release (ER). This study aimed to assess the effect of aging and dose escalation on patient-reported treatment benefit, after changing their first Overactive Bladder (OAB) therapy with tolterodine-ER to fesoterodine in daily clinical practice. METHODS: A post-hoc analysis of data from a retrospective, cross-sectional and observational study was performed in a cohort of 748 OAB adults patients (OAB-V8 score ≥8), who switched to fesoterodine from their first tolterodine-ER-based therapy within the 3-4 months before study visit. Effect of fesoterodine doses (4 mg vs. 8 mg) and patient age (<65 yr vs. ≥65 yr) were assessed. Patient reported treatment benefit [Treatment Benefit Scale (TBS)] and physician assessment of improvement with change [Clinical Global Impression of Improvement subscale (CGI-I)] were recorded. Treatment satisfaction, degree of worry, bother and interference with daily living activities due to urinary symptoms were also assessed. RESULTS: Improvements were not affected by age. Fesoterodine 8 mg vs. 4 mg provides significant improvements in terms of treatment benefit [TBS 97.1% vs. 88.4%, p < 0.001; CGI-I 95.8% vs. 90.8% p < 0.05)], degree of worry, bother and interference with daily-living activities related to OAB symptoms (p <0.05). CONCLUSIONS: A change from tolterodine ER therapy to fesoterodine with dose escalation to 8 mg in symptomatic OAB patients, seems to be associated with greater improvement in terms of both patient-reported-treatment benefit and clinical global impression of change. Improvement was not affected by age.

Quality of life in patients with overactive bladder: validation and psychometric properties of the Spanish Overactive Bladder Questionnaire-short Form.

BACKGROUND: Overactive bladder (OAB) is characterized by the symptoms of urinary urgency or urge incontinence, which appear without a local pathological or metabolic explanation. OAB is defined by symptoms and the evaluation of treatment effectiveness should be based upon patient perceptions. The Overactive Bladder Questionnaire-Short Form (OAB-q SF) is a brief, self-administered patient-reported outcomes tool with two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB. OBJECTIVE: This study aimed to adapt the OAB-q SF into Spanish and to estimate its psychometric properties in patients with symptomatic overactive bladder. METHODS: The Spanish version of the OAB-q SF was administered on two occasions, 3 months apart, to a set of patients of both sexes, over 18 years of age, diagnosed with OAB, scoring ≥8 on the OAB-V8 scale (a self-reported 8-item OAB screening and awareness tool), and able to understand patient-reported-outcome instruments written in Spanish. Patients were recruited consecutively at urology clinics. Feasibility, internal consistency (Cronbach's alpha), test-retest reliability, structure of instrument, criteria and construct validity and responsiveness were examined using classic test theory statistics. RESULTS: Data from 246 OAB patients (mean age 57.7 years, 76% women, 99% Caucasian, 37% workers and 36% with a primary education) were evaluated. Floor and ceiling effects ranged between 0.8% and 33%, and missing items were below 2%. Cronbach's alphas attained 0.811 and 0.922 for symptom-bother and HR-QOL domains, respectively. These two subscales matched the original structure and explained variances above 50%, which correlated moderately with EQ-5D (EuroQol) [r = -0.28 and r = +0.31, respectively (p < 0.001 in both cases)]. A significant change in OAB-q SF mean domain scores (-23.8; 95% CI -26.3, -21.3; and +17.7; 95% CI 15.4, 20.6; p < 0.001 in both cases; [effect sizes: 1.32 and 0.98]) was observed after 3 months of medical treatment. CONCLUSION: The Spanish version of the OAB-q SF demonstrated sufficiently strong psychometric properties of reliability, validity and responsiveness to be used in the measurement of OAB symptom severity and HR-QOL.

Supervivencia del cáncer en el País Vasco entre 1995-2004 / Cancer survival between 1995 and 2004 in the Basque Country, Spain

Fundamentos: las diferencias geográficas descritas en el pronóstico de los pacientes de cáncer en el País Vasco han sido atribuidas a la diferente incidencia en tumores de diferente letalidad. Por ello, se incluye la supervivencia relativa del cáncer ajustada por la casuística para estimar la supervivencia del conjunto de los tumores malignos por provincias y comarcas sanitarias, utilizando los datos de 1995 a 2004. El objetivo del trabajo es estimar la supervivencia de los tumores malignos en el País Vasco por provincias y comarcas sanitarias durante el período 1995-2004. Métodos: se incluyeron 93.585 tumores malignos del registro poblacional de cáncer. Se calculó la supervivencia relativa (SR) a 5 años con el método de Ederer. Se estimó el exceso de riesgo relativo (ERR) de muerte a los 5 años con el modelo lineal generalizado, estandarizando por edad y ajustando por sexo, período de diagnostico y casuística. Resultados: la SR a los 5 años aumentó en el período 2000-2004 con respecto a 1995-1999 con valores que oscilaron por comarcas entre el 46-58% y el 57-65% en hombres y mujeres, respectivamente. Se observó un exceso de riesgo de muerte en pacientes de Bizkaia (ERR= 1,06; IC95%: 1,03-1,09, efecto que se observo en casi todas sus comarcas. Por el contrario, en Gipuzkoa, sólo las comarcas Gipuzkoa y Tolosa mostraron diferencias significativas (ERR=1,07; IC95%: 1,02-1,13 y ERR=0,91; IC95%: 0,84-0,98, respectivamente), las cuales desaparecieron al ajustar el modelo. Conclusiones: dentro del Pais Vasco fueron los pacientes de Bizkaia, a excepción de la comarca Uribe, los que presentaron peor pronóstico(AU)

Background: geographic differences described in the prognosis of cancer patients in the Basque Country have been attributed to a different incidence in tumours with different lethality. Therefore, cancer relative survival adjusted by case-mix was included to estimate cancer survival by provinces and health regions, using data from 1995 to 2004. Methods: a total of 93 585 cases of malignant tumours were identified from a population-based cancer registry. The five-year relative survival (RS) was calculated using Ederer's method. The five-year relative excess risk (RER) of death was estimated with a generalised linear model, standardized by age and adjusted for sex, date of diagnosis and case-mix. Results: the five-year RS increased fromperiod 1995-1999 to 2000- 2004, this latter, with values ranging by health regions between 46-58% and 57-65% in men and women, respectively. There was an excess risk of death in Bizkaia (RER=1.06, CI95%: 1.03-1.09), this same effect being identified in almost all the health regions in the province. In contrast, in Gipuzkoa province, differences were only statistically significant in the Gipuzkoa and Tolosa health regions (RER=1.07; CI95%: 1.02-1.13 and RER=0.91; CI95%: 0.84-0.98, respectively), and even these disappeared after adjusting for potential confounders. Conclusions: cancer patients of Bizkaia, except for the Uribe health region, presented a worse prognosis(AU)

Cranial ultrasound and chronological changes in molybdenum cofactor deficiency.

Molybdenum cofactor is essential for the function of three human enzymes: sulphite oxidase, xanthine dehydrogenase, and aldehyde oxidase. Molybdenum cofactor deficiency is a rare autosomal recessively inherited disease. Disturbed development and damage to the brain may occur as a result of accumulation of toxic levels of sulphite. The CT and MRI findings include severe early brain abnormalities and have been widely reported, but the cranial US imaging findings have seldom been reported. We report a chronological series of cranial US images obtained from an affected infant that show the rapid development of cerebral atrophy, calcifications and white matter cysts. Our report supports the utility of cranial US, a noninvasive bed-side technique, in the detection and follow-up of these rapidly changing lesions.