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Biomedical subjects

J A Sacristán

Publications and source records attributed to J A Sacristán.

At least 19 recordsLinked to original sources
PubMed2004

Psychometric validation of a generic health-related quality of life measure (EQ-5D) in a sample of schizophrenic patients.

OBJECTIVE: The aim of this study was to evaluate the construct validity of a generic health related quality of life (HRQOL) instrument - the EQ-5D - in a sample of schizophrenic patients receiving antipsychotic treatment. RESEARCH DESIGN AND METHODS: A total of 2128 schizophrenic patients treated with olanzapine, 417 treated with risperidone, and 112 with haloperidol responded to the EQ-5D. The study also assessed the effect of patient age, gender, and co-morbidity variables on patient's HRQOL Main outcomes measures: EQ-5D scores at the start of treatment and after 3 and 6 months of therapy were compared with results from the Clinical Global Impression (CGI) severity of illness scale and the (GAF) scale. The effect of antipsychotics and sociodemographic variables on patient's HRQOL over time was tested through a three-factor doubly multivariate repeated measures MANCOVA. RESULTS: High scores in the GAF scale and low scores in the CGI were linked with high scores on the EQ-5D scale. The correlational effects observed between the EQ-5D and the clinical indices ranged from 0.33 to 0.54. A significant effect of 'visit time' as well as an interaction of 'visit time' x drug, 'visit time' x gender, and 'visit time' x co-morbidity was observed. CONCLUSIONS: Results suggest the EQ-5D is a valid instrument capable of detecting HRQOL differences between schizophrenic patients with different degrees of severity of illness.

Antipsychotic Agents↗
PubMed2004

The validity and reliability of the global index of safety (GIS).

OBJECTIVE: The global index of safety (GIS) is an adverse event (AE) based instrument designed to evaluate the safety profile of drugs. This paper presents the evaluation of the inter-rater reliability and validity of a 94-item GIS for antipsychotics through Rasch analysis. RESEARCH DESIGN AND METHODS: A total of 194 psychiatrists participating in an outpatient pharmacoepidemiologic study of olanzapine in schizophrenia rated the severity that each AE would have on a 5-point scale. Reliability was determined through a paired comparison design involving the new independent ratings of 101 different psychiatrists participating in another study of olanzapine in acute inpatient units. Spearman's, Pearson's and Intra-class correlation (ICC) coefficients were used to estimate the inter-rater reliability of the AE weights. Validity was analyzed through the Rasch rating scale model. RESULTS: Reliability coefficient estimates were excellent (Spearman = 0.99, Pearson = 0.99, ICC = 0.98), supporting the inter-rater reliability of the item weights. Through goodness-of-fit statistics and the investigation of the hierarchy of item calibrations, Rasch analysis confirmed the validity of the instrument. CONCLUSION: The data presented here on inter-rater reliability estimates of adverse events related to antipsychotic drugs indicate that GIS is a promising alternative for the evaluation of the safety profile of drugs.

Adverse Drug Reaction Reporting Systems↗
PubMed2003

Bone mineral density referral for dual-energy X-ray absorptiometry using quantitative ultrasound as a prescreening tool in postmenopausal women from the general population: a cost-effectiveness analysis.

The aim of our study was to assess, from the perspective of the National Health Services in Spain, the cost-effectiveness of quantitative ultrasound (QUS) as a prescreen referral method for bone mineral density (BMD) assessment by dual-energy X-ray absorptiometry (DXA) in postmenopausal women of the general population. Using femoral neck DXA and heel QUS. We evaluated 267 consecutive postmenopausal women 65 years and older and attending primary care physician offices for any medical reason. Subjects were classified as osteoporotic or nonosteoporotic (normal or osteopenic) using the WHO definition for DXA. Effectiveness was assessed in terms of the sensitivity and specificity of the referral decisions based on the QUS measurement. Local costs were estimated from health services and actual resource used. Cost-effectiveness was evaluated in terms of the expected cost per true positive osteoporotic case detected. Baseline prevalence of osteoporosis evaluated by DXA was 55.8%. The sensitivity and specificity for the diagnosis of osteoporosis by QUS using the optimal cutoff thresholds for the estimated heel BMD T-score were 97% and 94%, respectively. The average cost per osteoporotic case detected based on DXA measurement alone was 23.85 euros. The average cost per osteoporotic case detected using QUS as a prescreen was 22.00 euros. The incremental cost-effectiveness of DXA versus QUS was 114.00 euros per true positive case detected. Our results suggest that screening for osteoporosis with QUS while applying strict cufoff values in postmenopausal women of the general population is not substantially more cost-effective than DXA alone for the diagnosis of osteoporosis. However, the screening strategy with QUS may be an option in those circumstances where the diagnosis of osteoporosis is deficient because of the difficulty in accessing DXA equipment.

Absorptiometry, Photon↗
PubMed2003

A Rasch model analysis to test the cross-cultural validity of the EuroQoL-5D in the Schizophrenia Outpatient Health Outcomes Study.

OBJECTIVE: To investigate the pan-European, cross-cultural validity of the EuroQol-5D (EQ-5D) for assessing quality of life in the Schizophrenia Outpatient Health Outcomes (SOHO) Study. METHOD: The EQ-5D items investigated were mobility, self-care, usual activities, pain/discomfort and anxiety/depression. A Rasch rating scale model (a form of differential item functioning) was used to identify invariance of item calibrations for the 10 European countries participating in the SOHO study. RESULTS: There was general congruence in the EQ-5D item calibration pattern. The rank of average EQ-5D item calibrations was similar for all countries except Denmark. Denmark showed slight misfits for mobility and pain/discomfort. CONCLUSION: The EQ-5D is an appropriate measure of health-related quality of life across European countries and translations.

Adult↗
PubMed2001

Subjective response to antipsychotic treatment and compliance in schizophrenia. A naturalistic study comparing olanzapine, risperidone and haloperidol (EFESO Study).

BACKGROUND: In order to compare the effectiveness of different antipsychotic drugs in the treatment of schizophrenia it is very important to evaluate subjective response and compliance in patient cohorts treated according to routine clinical practice. METHOD: Outpatients with schizophrenia entered this prospective, naturalistic study when they received a new prescription for an antipsychotic drug. Treatment assignment was based on purely clinical criteria, as the study did not include any experimental intervention. Patients treated with olanzapine, risperidone or haloperidol were included in the analysis. Subjective response was measured using the 10-item version of the Drug Attitude Inventory (DAI-10), and treatment compliance was measured using a physician-rated 4 point categorical scale. RESULTS: A total of 2128 patients initiated treatment (as monotherapy) with olanzapine, 417 with risperidone, and 112 with haloperidol. Olanzapine-treated patients had significantly higher DAI-10 scores and significantly better treatment compliance compared to both risperidone- and haloperidol-treated patients. Risperidone-treated patients had a significantly higher DAI-10 score compared to haloperidol-treated patients. CONCLUSION: Subjective response and compliance were superior in olanzapine-treated patients, compared to patients treated with risperidone and haloperidol, in routine clinical practice. Differences in subjective response were explained largely, but not completely, by differences in incidence of EPS.

Adult↗
PubMed2001

Global index of safety (GIS): a new instrument to assess drug safety.

There is an asymmetry between the extraordinary development of measures and tools aimed at studying the beneficial effects of the drugs and the more limited methods to assess their safety profile. The goal of our study was to develop a global measuring tool to assess drugs' safety. We conducted a survey of Spanish psychiatrists in mental health centers and outpatient treatment units to assess the severity scores that they would assign to a list of the most common adverse events (AEs) that usually occur with antipsychotic treatment. The severity scores were then applied to the list of AEs that really occurred along a naturalistic pharmacoepidemiological study on the use of different antipsychotics in the treatment of schizophrenia. The Global Index of Safety (GIS) of the experimental group treated with olanzapine (OLZ) was compared with the GIS of the control group and with the GIS of specific antipsychotics for which the number of treated patients was greater than 100. A total of 194 psychiatrists rated the severity of each AE on a scale of 1 (insignificant) to 5 (extremely severe). The individual severity was applied to the 2949 schizophrenic patients included in a pharmacoepidemiological study. A GIS was calculated for every group of patients receiving the same treatments. The GIS of the control group was higher (4.3) than that calculated from the experimental group (2.5) (P < 0.001). The GIS of the risperidone (3.6) and haloperidol (6.0) subgroups were higher than that calculated from the OLZ group (P < 0.001). The development of a GIS may facilitate the comparison of the safety of several drugs and may constitute a very valuable aid for those involved in selecting drugs.

Adverse Drug Reaction Reporting Systems↗
PubMed2000

Doses of olanzapine, risperidone, and haloperidol used in clinical practice: results of a prospective pharmacoepidemiologic study. EFESO Study Group. Estudio Farmacoepidemiologico en la Esquizofrenia con Olanzapina.

OBJECTIVE: The objectives of this study were to determine the doses of olanzapine (OLZ), risperidone (RIS), and haloperidol (HAL) used in clinical practice in outpatients with schizophrenia and the rates of occurrence of extrapyramidal symptoms (EPS) and other adverse events, clinical response, and use of concomitant medications. METHODS: The present study involved a subset of patients from a 6-month, open-label, prospective observational study. Data were collected by 293 psychiatrists at mental health centers and other outpatient treatment facilities in Spain. Medications and doses used, occurrence of EPS and other adverse events, and scores on the Clinical Global Impression (CGI) of Severity Scale and Global Assessment of Function (GAF) were recorded. Clinical response was defined as a decrease of > or = 2 points on the CGI, with a final CGI score < or = 4. RESULTS: A total of 2657 patients were included in the analysis. The initial and overall mean daily doses for the 3 groups were as follows: OLZ, 12.2 and 13.0 mg, respectively; RIS, 5.2 and 5.4 mg; and HAL, 13.9 and 13.6 mg. Initial and overall median daily doses were the same in each group: OLZ, 10 mg; RIS, 6 mg; and HAL, 10 mg. A significantly lower proportion of OLZ-treated patients (36.9%) experienced EPS compared with RIS-treated (49.6%) and HAL-treated (76.0%) patients (P < or = 0.001). A significantly lower proportion of patients in the OLZ group (47.8%) experienced adverse events compared with patients in the RIS (57.2%) and HAL (79.8%) groups (P < or = 0.001). A significantly greater proportion of OLZ-treated patients (37.3%) were responders compared with RIS-treated patients (31.5%) (P < 0.05). In all 3 groups, patients who had an initial CGI score > or = 5 received significantly higher overall mean daily doses than did patients with an initial CGI score < 5 (P < 0.001). A significantly lower proportion of OLZ-treated patients (10.2%) were receiving concomitant anticholinergic medication at the end of the study (month 6) compared with RIS-treated (19.9%) and HAL-treated (44.0%) patients (P < 0.001). CONCLUSION: The mean daily doses recorded in this analysis based on data from a naturalistic setting are consistent with recommendations based on clinical trials. Compared with both RIS- and HAL-treated patients, OLZ-treated patients were less likely to experience EPS or other adverse events, and less likely to use concomitant anticholinergic medications. OLZ-treated patients were also more likely to respond to treatment than were RIS-treated patients.

Adult↗
PubMed2000

Economic evaluation in a randomized phase III clinical trial comparing gemcitabine/cisplatin and etoposide/cisplatin in non-small cell lung cancer.

INTRODUCTION: Information on the relative cost-effectiveness of treatments for cancer is being increasingly sought as pressure on health care resources increases. The objective of this study was to assess the cost-effectiveness of gemcitabine/cisplatin (GC) versus cisplatin/etoposide (CE) in patients with advanced non-small cell lung cancer (NSCLC), using resource utilization data collected in conjunction with the first randomized clinical trial comparing both combinations. METHODS: Efficacy and medical care resource utilization data were collected prospectively in an open-label, multicenter, randomized, comparative, phase III trial conducted in Spain which compared gemcitabine/cisplatin and cisplatin/etoposide in 135 chemonaive patients with Stage IIIB or IV NSCLC. There were no differences between both regimens when survival was used as primary end-point, so a cost-minimization analysis was used to compare them. In addition, cost-effectiveness analyses were conducted when percentage of responses and time to progression were used as secondary end-points. RESULTS: There were no differences between both regimens when survival was selected as the efficacy end-point. Despite the higher chemotherapy cost of GC when compared to CE, there were no differences in total direct costs (584523 pts for GC and 589630 pts for CE; P=NS) between both regimens. Potential savings with GC were mainly associated with a decrease in hospitalization rate. There were differences in favor of GC when response rate (40.6% for GC and 21.9% for CE; P<0.05) and time to disease progression (8.7 months for GC and 7.2 months for CE; P<0. 05) were used as clinical end-points. GC presented a favorable cost-effectiveness profile when compared to CE. CONCLUSIONS: This prospective economic evaluation conducted alongside a clinical trial offers valuable preliminary information on the potential efficiency of the combination gemcitabine-cisplatin in NSCLC. Future assessments based on larger clinical trials focused on survival and naturalistic economic studies conducted in real clinical practice settings are necessary to confirm these findings.

Aged↗
PubMed2000

Comparative pharmacoeconomic study of vancomycin and teicoplanin in intensive care patients.

Randomized clinical trials and meta-analyses have not demonstrated any statistically significant differences between teicoplanin and vancomycin with regard to efficacy. A cost-minimization analysis was conducted to compare the economical impact of the treatment with vancomycin and teicoplanin in intensive care patients. Information on resource utilization was retrospectively collected from 100 consecutive clinical histories of patients hospitalized in a Spanish Intensive Care Unit, who had been given a glycopeptide antibiotic (50 teicoplanin and 50 vancomycin) for the treatment of a suspected or proven infection. Although personnel, material, and monitoring costs were higher in the vancomycin group, the acquisition costs and the total costs were much lower in this group, so the resulting total costs per day were 5508 ptas (33 euros) for vancomycin-treated patients and 9893 ptas (59.5 euros) for teicoplanin-treated patients. The savings with vancomycin for a 10-day course of treatment would be approximately 40697 ptas (244.5 euros) per patient. Results were consistent for a variety of conditions that were included in the sensitivity analysis.

Adolescent↗
PubMed2000

Cost-effectiveness of fluoxetine plus pindolol in patients with major depressive disorder: results from a randomized, double-blind clinical trial.

Some preliminary studies have suggested that the beta-adrenoceptor 5-HT1A antagonist pindolol (PIN) could increase the effect of selective serotonin reuptake inhibitors (SSRIs). We prospectively estimated the cost-effectiveness of fluoxetine and pindolol versus fluoxetine plus placebo, using results from the first double-blind randomized clinical trial comparing both treatments. Efficacy and medical care resource utilization were collected prospectively in a parallel, randomized, double-blind clinical trial conducted in a single centre in Spain. Average cost-effectiveness (cost/% response and cost/% remission) as well as the incremental cost-effectiveness were calculated for both treatments. A 'bootstrap' method was used to calculate confidence limits around the incremental cost-effectiveness ratio. A significantly greater percentage of patients (one-tailed P < 0.05) in the fluoxetine FLX + PIN group than in the FLX + PLA group had experienced a therapeutic response (74.5% versus 58.97%) at 6 weeks. Direct medical costs were lower in the FLX + PIN group (mean 2508 pesetas per patient) than in the FLX + PLA group (mean 31870 pesetas per patient). Hospital admissions due to worsening of depressive symptoms were significantly lower (P < 0.05) in the FLX + PIN group (0/55) than in the FLX + PLA group (4/56). The observed differences in average costs and percentage response in the study were -29362 pesetas (< 0) and 15.6% (> 0), respectively, and the resulting cost-effectiveness ratio was negative. These outcomes indicate that the FLX + PIN option completely dominates FLX + PLA. These results suggest that, over a course of 6 weeks of treatment, the combination of fluoxetine and pindolol incurs lower direct medical costs than treatment with fluoxetine placebo. Despite their limitations, economic assessments in addition to clinical trials allow a 'dynamic assessment' on the potential success of the drug, both from a clinical and an economic point of view, allowing decisions on priorities to be made earlier.

Adult↗
PubMed2000

The safety of olanzapine compared with other antipsychotic drugs: results of an observational prospective study in patients with schizophrenia (EFESO Study). Pharmacoepidemiologic Study of Olanzapine in Schizophrenia.

INTRODUCTION: Results of controlled clinical trials should be confirmed through safety and effectiveness studies in nonselected patient cohorts treated according to routine clinical practice. METHOD: Outpatients with schizophrenia (ICD-10 criteria) entered this prospective, naturalistic study when they received a new prescription for an antipsychotic drug. Treatment assignment was based on purely clinical criteria, as the study did not include any experimental intervention. Safety was evaluated through the collection of spontaneous adverse events and a specific questionnaire for extrapyramidal symptoms. Global clinical status was measured through the Clinical Global Impressions-Severity (CGI-S) and the Global Assessment of Functioning (GAF) scales. RESULTS: From the 2967 patients included, 2128 patients were treated with olanzapine as monotherapy or combined with other drugs (olanzapine group), and 821 were treated with other antipsychotic drugs as monotherapy or combined with other drugs (control group). There were no statistical differences between treatment groups at baseline regarding age, gender, disease duration, or severity of symptoms. Olanzapine was well tolerated and effective in this study. Overall incidence of adverse events was significantly lower in the olanzapine group compared with the control group (p < .001). Somnolence and weight gain were significantly more frequent in the olanzapine group, and akathisia, dystonia, extrapyramidal syndrome, hypertonia, hypokinesia, and tremor were significantly higher in the control group. Clinical improvement at endpoint, measured through the mean change in the CGI-S and the GAF, was significantly higher in the olanzapine group compared with the control group (p = .004). CONCLUSION: These results show that olanzapine is safe and effective in nonselected schizophrenic outpatients and are consistent with the efficacy and safety profile that olanzapine has shown in previous controlled clinical trials.

Adolescent↗
PubMed1999

Service utilization and costs of first-onset schizophrenia in two widely differing health service areas in North-East Spain. PSICOST Group.

OBJECTIVE: The aim of the study was to analyse the cost-incidence of schizophrenia in two areas with widely differing health service systems. METHOD: The costs of patients with schizophrenia in the 3 years after the first service contact were evaluated (i) in an area (A) with fully developed mental health community programmes and (ii) in another area (B) without such programmes. The assessment included a standard description of services, as well as clinical, social and disability aspects. RESULTS: Sociodemographic and clinical characteristics were comparable. The mean direct costs for both areas in the 3-year period were, respectively, 4287 dollars and 6540 dollars in year 1, 2416 dollars and 2888 dollars in year 2, and 2120 dollars and 1862 dollars in year 3. Direct costs in area A were 35% lower than those in area B during the first year, 16.4% lower during the second year, and 12.2% higher during the third year. CONCLUSION: Direct costs were higher in the area that lacked intermediate mental health services, mainly due to hospitalization. Non-provision of intermediate mental health care may lead to inefficiencies in the healthcare system.

Adult↗
PubMed1999

[The costs of treatment with the new antidepressants in clinical practice].

OBJECTIVE: To assess if, in usual clinical practice, the patterns of use of new antidepressant are associated to different health resource utilisation. DESIGN: Naturalistic, retrospective, observational study. SETTING: Urban health center. PATIENTS: DSM-IIIR diagnostic criteria of depressive disorder and treatment with a new antidepressant (n = 328). INTERVENTIONS: Information on resource utilisation was collected in those patients treated with fluoxetine (FLX), fluvoxamine (FLV) sertraline (SER), paroxetine (PAR) and venlafaxine (VLF). Direct, indirect and total costs were compared according to the different patterns of use (stable therapy, upward dose titration, switching or augmentation) and according to the initially prescribed antidepressant. The follow-up period was 6 months. RESULTS: Direct and total daily costs of those patients with unestable therapy (upward dose titration, switching or augmentation) were 55% (p < 0.01) and 87% (p = 0.001) higher than for patients with stable therapy, respectively. Patients who initiated therapy on SER, VLF and PAR had 35% (p < 0.05), 80% (p < 0.05) and 37% (p < 0.05), respectively, higher average total costs per day than patients who initiated therapy with FLX. Regarding direct costs, patients who initiated therapy on SER and VLF had 48% (p < 0.001) and 58% (p < 0.05) higher average costs per day than patients who initiated therapy with FLX. CONCLUSIONS: New antidepressants show different patterns of use in a clinical practice setting, being FLX the agent more associated to a stable pattern of use. The pattern of use is associated to different health resource utilisation. Patients under stable therapy show lower health costs than those who need upward titration, switching or augmentation strategies. It is necessary to conduct randomized naturalistic studies to confirm these results.

Adult↗