L Cordero

Pattern of healthcare resource utilization and direct costs associated with manic episodes in Spain

BackgroundAlthough some studies indicate that bipolar disorder causes high health care resources consumption, no study is available addressing a cost estimation of bipolar disorder in Spain. The aim of this observational study was to evaluate healthcare resource utilization and the associated direct cost in patients with manic episodes in the Spanish setting.MethodsRetrospective descriptive study was carried out in a consecutive sample of patients with a DSM-IV diagnosis of bipolar type I disorder with or without psychotic symptoms, aged 18 years or older, and who were having an active manic episode at the time of inclusion. Information regarding the current manic episode was collected retrospectively from the medical record and patient interview.ResultsSeven hundred and eighty-four evaluable patients, recruited by 182 psychiatrists, were included in the study. The direct cost associated with healthcare resource utilization during the manic episode was high, with a mean cost of nearly €4,500 per patient, of which approximately 55% corresponded to the cost of hospitalization, 30% to the cost of psychopharmacological treatment and 10% to the cost of specialized care.ConclusionsOur results show the high cost of management of the patient with a manic episode, which is mainly due to hospitalizations. In this regard, any intervention on the management of the manic patient that could reduce the need for hospitalization would have a significant impact on the costs of the disease.

Estimation of a multiattribute utility function for the Spanish version of the TooL questionnaire.

OBJECTIVES To estimate and assess the psychometric properties of a multiattribute utility function (MAUF) for the Spanish version of the Tolerability and Quality of Life (TooL questionnaire). METHODS Balanced data on 243 patients diagnosed with schizophrenia or bipolar disorder were gathered. In addition to the demographic and clinical variables and the usual generic health-related quality of life (HRQoL) questionnaires (EuroQol-5D [EQ-5D] and Short Form-6D [SF-6D]), instruments considered included the Spanish versions of the Positive and Negative Symptoms of Schizophrenia Scale (PANSS), Young Mania Rating Scale (YMRS), Montgomery-Asberg Depression Rating Scale (MADRS), Udvalg for Kliniske Undersogelser (UKU), and Clinical Global Impression Severity (CGIS) scale. MAUF parameters estimation involved a number of visual analogue scale (VAS) and time trade-off (TTO) ratings that proved difficult to be performed by the patients. After checking for inconsistencies in patient responses, the original sample was reduced to a still balanced subsample of 70 individuals. A multiplicative-form MAUF was estimated following the standard methodology. RESULTS Good convergent validity was demonstrated because utility estimates from the MAUF presented strong correlations with utilities from the generic HRQoL instruments included: SF-6D (0.66, P < 0.01), EQ-5D (0.69, P < 0.01), and moderate correlations with the rest of instruments considered: PANSS (-0.27, P = 0.10), YMRS (-0.30, P = 0.08), MADRS (-0.48, P < 0.01), UKU (-0.35, P < 0.01). Criterion validity was also met because differences in mean utilities by clinical severity were found (P < 0.01). Utilities from the MAUF covered a wider range of health states [0.04,1.00] than those from the SF-6D [0.53,1.00] and EQ-5D [0.23,0.96]. CONCLUSIONS Utilities from the MAUF showed good psychometric properties, serving as a complement to generic health utilities. If misapplied, however, utilities from this instrument might favor the positive evaluation of drugs showing fewer associated side effects.

The subjective well-being under neuroleptic scale - short version (SWN-K) and the SF-36 health survey as quality of life measures in patients with schizophrenia.

Purpose The desired outcome in schizophrenia treatment has evolved from symptom management to maximization of quality of life and functional recovery. The aim of this study was to assess the relationship between a specific well-being measure, the Subjective Well-being under Neuroleptic Scale – short version (SWN-K), and the SF-36 Health Survey as a generic quality of life measure. Patients and methods A multicenter, cross-sectional study was conducted with clinically stable outpatients diagnosed with schizophrenia. Spearman’s rank correlation was used to assess the associations between the SWN-K total score, its five subscales, and the SF-36 domains. Results Ninety-seven patients were included in the study. The mean age was 35 years (standard deviation = 10) and 72% were male. All correlations among domains were positive and most were statistically significant. The bodily pain domain of the SF-36 presented the lower correlations with the SWN-K (rho range 0.10–0.25), whereas the other seven domains correlated significantly (rho range 0.49–0.60, all P < 0.001). The largest correlations were obtained between the SWN-K and the SF-36 domains of general health (rho = 0.53), mental health (rho = 0.60), and vitality (rho = 0.54). Conclusion The positive but nevertheless moderate correlations observed between a specific well-being instrument and a generic quality of life scale supports the inclusion of diagnosis-specific tools for outcome assessment of patients with schizophrenia.

Assessment of pharmacological strategies for management of major depressive disorder and their costs after an inadequate response to first-line antidepressant treatment in primary care

BackgroundThe aim of the study was to determine the most common treatment strategies and their costs for patients with an inadequate response to first-line antidepressant treatment (AD) in primary care.MethodA retrospective cohort study of medical records from six primary care centers was conducted. Adults with a major depressive disorder diagnosis, at least 8 weeks of AD treatment after the first prescription, and patient monitoring for 12 months were analyzed. Healthcare (direct cost) and non-healthcare costs (indirect costs; work productivity losses) were described.ResultsA total of 2,260 patients were studied. Forty-three percent of patients (N = 965) presented an inadequate response to treatment. Summarizing the different treatment approaches: 43.2% were switched to another AD, 15.5% were given an additional AD, AD dose was increased in 14.6%, and 26.7% remained with the same antidepressant agent. Healthcare/annual costs were 451.2 Euros for patients in remission vs. 826.1 Euros in those with inadequate response, and productivity losses were 991.4 versus 1,842.0 Euros, respectively (p < 0.001).ConclusionAntidepressant switch was the most common therapeutic approach performed by general practitioners in naturalistic practice. A delay in treatment change when no remission occurs and a significant heterogeneity in management of these patients were also found.

Costes y factores asociados a las respuestas óptima y subóptima al tratamiento del trastorno depresivo mayor en atención primaria

OBJECTIVE To evaluate the compliance, persistence and costs of the treatment of major depressive disorder (MDD) in the setting of Primary Care, placing emphasis on the different aspects of those patients with an initial suboptimal response to antidepressant treatment. DESIGN A retrospective observational study using the population registers of Badalona Healthcare Services. The inclusion criteria consisted of; age ≥18 years, initial episode during 2008-2009, and to be on antidepressant treatment for at least 8 weeks after the first prescription. The follow-up was 12 months. Two study groups were formed, patients with suboptimal response, and remission. MAIN MEASUREMENTS Sociodemographic data, compliance and adherence to treatment, health costs (direct and indirect). RESULTS A total of 2,260 subjects were analysed (mean age 58.8 years, 74% women). Just under half (42.7%, 95% CI; 40.0-46.4%) had a suboptimal response to the treatment. These patients had a higher mean age, a higher proportion of women, and pensioners, as well as higher comorbidity, compared to the remission group. They also had poorer compliance percentages (65.1% vs. 67.7%) and treatment persistence at 12 months (31.8% vs. 53.2%), respectively, P<.001. The annual health costs were, 826.1€ for patients with a suboptimal response vs. 451.2€ in patients in remission; loss of productivity 1,842.0€ vs. 991.4€, respectively; P<.001. The factors associated to a suboptimal response were; lack of compliance (OR=1.7), years with the disorder (OR=1.2), age (OR=1.1) and presence of comorbidity (OR=1.1). CONCLUSIONS The patients with an initial suboptimal response to antidepressant treatment had a higher comorbidity, lower therapeutic compliance, and incurred higher total costs, particularly in losses in work productivity.

PMH43 THE SPANISH VERSION OF THE TOOL QUESTIONNAIRE: A USEFUL MEASURE FOR EVALUATING THE HRQOL AND UTILITIES FROM SCHIZOPHRENIC AND BIPOLAR PATIENTS

PMH42 HEALTH-RELATED QUALITY OF LIFE OF MARRIED,WORKING WOMENWITH CHILDREN (SUPERWOMAN SYNDROME) IN KOREA Kim S, Park S, Park H Kyung Hee University, Seoul, South Korea, Kyung Hee University, Yongin, Gyeonggi-Do, South Korea, Pochon CHA University, Sungnam, Gyeonggi-Do, South Korea OBJECTIVES: To assess health-related quality of life (QoL) of married, working women with children (working-moms) faced with psychosocial stress (known as superwoman syndrome). METHODS: A total of 200 working-moms (aged 40.2 5.3) were recruited randomly by telephone, and a questionnaire was administered to classify types of superwomen syndrome: selfreliance type (ST), conflict type (CT), and additive type (AT). To compare, a community samples of aged group (n = 80, aged 70.0 5.9) were recruited at a local community center. We measured QoL using SF-36v2 for both groups. RESULTS: As expected younger working-moms reported significantly higher physical function (PF: 79.7 18.7 vs. 71.9 21.9; p = .0031) and mental health (MH: 49.2 15.3 vs. 41.0 14.8; p < .0001). On the contrary role-physical (RP: 78.9 23.6 vs. 80.5 22.5) and role-emotional (RE: 77.2 25.0 vs. 83.2 24.0) scores were lower than aged. Additionally, social functioning (SF) was significantly lower in working-moms (p < .0003). Further by types, most physical-related scales of ST group (n = 10) were significantly higher (all p’s < 0.0025), whereas vitality (VT) and MH were lower than aged.Majority of working-momswere classified as CT group (n = 169). They reported the same QoL patterns as total samples. Notably, AT group (n = 21) reported only MH (62.9 13.8 vs. 41.0 14.8; p < 0.0001) was significantly higher than aged, and rest were either similar (PF, VT), or significantly lower than aged (RP: 62.8 24.6 vs. 80.5 22.5, RE: 55.1 26.6 vs. 83.2 24.0; all p’s < 0.002). CONCLUSIONS: Most workingmoms reported higher functioning and well-being, but in fact they were limited in playing roles due to physical andmental problems. It is suspected that they are denying and suppressing their various health problems. Particularly, additive group report they are in well-being, but the study showed they are definitely not. They even may develop mentally and physically-related diseases in the near future. Therefore, a cohort study is urgent for working, married women with children in Korea.

Financial consequences of a payment-by-results scheme in Catalonia: gefitinib in advanced EGFR-mutation positive non-small-cell lung cancer.

Abstract Background: In 2011 the first payment-by-results (PbR) scheme in Catalonia was signed between the Catalan Institute of Oncology (ICO), the Catalan Health Service, and AstraZeneca (AZ) for the introduction of gefitinib in the treatment of advanced EGFR-mutation positive non-small-cell lung cancer. The PbR scheme includes two evaluation points: at week 8, responses, stabilization and progression were evaluated, and at week 16 stabilization was confirmed. AZ was to reimburse the total treatment cost of patients that failed treatment, defined as progression at weeks 8 or 16. Objective: To estimate the financial consequences of this PbR reimbursement model and determine the perception of the stakeholders involved in the agreement. Methods: Differential drug costs between two scenarios, with and without the PbR, were calculated. A qualitative investigation of the organizational elements was performed by interviewing the parties involved in the agreement. Results: Forty-one patients were included from June 2011 to October 2013 and assessed at two evaluation points. Clinical results were comparable to those observed in the pivotal studies of gefitinib. The difference in the cost of gefitinib using the PbR compared to the traditional purchasing scenario was 6.17% less at 8 weeks, 11.18% at 16 weeks and 4.15% less for the overall treatment. The PbR resulted in total savings of around €36,000 (€880 per patient). From an operational and organizational perspective, the availability of adequate data systems to measure outcomes and monitor accountability and the involvement of healthcare professionals were acknowledged as crucial. Conclusions: Tangible and intangible benefits were identified with respect to the interests of the parties involved. This has led to the incorporation of innovation for patients under acceptable conditions.

Sesgos de confusión por indicación y gravedad en estudios observacionales

Observational studies are subject to biases that may lead to misinterpretation of the results. This study aimed to determine the influence of omeprazole treatment on the duration of sick leave in patients with ankle sprains treated with non-steroidal anti-inflammatory drugs. We used the Ibermutuamur database. Contrary to our expectations, sick leave was longer in patients who received omeprazole than in those who did not. These findings were probably due to the influence of a bias due to confounding by severity, given that patients who received omeprazole had a worse kind of ankle sprain; however, a bias due to confounding by indication cannot be excluded. To avoid the influence of these systematic errors, biases should be monitored from the design stage to the data analysis stage.

Confounding bias due to indication and severity in observational studies

Observational studies are subject to biases that may lead to misinterpretation of the results. This study aimed to determine the influence of omeprazole treatment on the duration of sick leave in patients with ankle sprains treated with non-steroidal anti-inflammatory drugs. We used the Ibermutuamur database. Contrary to our expectations, sick leave was longer in patients who received omeprazole than in those who did not. These findings were probably due to the influence of a bias due to confounding by severity, given that patients who received omeprazole had a worse kind of ankle sprain; however, a bias due to confounding by indication cannot be excluded. To avoid the influence of these systematic errors, biases should be monitored from the design stage to the data analysis stage.