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Objective: To estimate the burden of nosocomial infections induced by carbapenem resistant Gram-negative (CRGN) pathogens in Spain, focusing on both the clinical and economic impact., Methods: The burden of disease was estimated using data from 2017 according to the availability of data sources. The impact, both clinical and economic, of the most frequent CRGN nosocomial infections (those produced by Klebsiella pneumoniae, Pseudomonasaeruginosa and Acinetobacter baumannii) was analysed. Incidence and mortality of CRGN nosocomial infections were estimated, as well as the direct and indirect costs produced by this health problem., Results: Approximately 376,346 patients are believed to have suffered a nosocomial infection in Spain in 2017; 3.2% of them due to CRGN bacilli. Infections by carbapenem-resistant P. aeruginosa produced the highest mortality rates (2578 deaths) when compared with A. baumannii (1571) and K. pneumoniae (415). Total economic costs of CRGN nosocomial infections in Spain were estimated to be €472 million in 2017, with 83% of the total cost caused by direct costs., Conclusion: CRGN nosocomial infections have a high clinical impact on patients' lives, high mortality rates, and represent one of the hospitalisation episodes with the most associated costs. Efforts should be focussed to implement preventive policies in order to avoid infections due to CRGN pathogens and the resulting burden, and to reduce direct costs due to morbimortality, specifically in those infections produced by P. aeruginosa., (Copyright © 2020. Publicado por Elsevier España, S.L.U.)

Background and Objective: Our goal was to assess expectations, preferences and treatment satisfaction in patients suffering from rheumatoid arthritis (RA) treated with infliximab and their relationship with health related quality of life in real clinical practice., Patients and Method: 198 patients with AR participated in the study who started medication with infliximab at the beginning of the survey. Evaluation of expectations, preferences, satisfaction, health related quality of life, clinic evolution of patients and safety were made 2, 6, and 14 weeks after, coinciding with infliximab transfusions., Results: More than 85% of the patients preferred to be treated in the hospital. They valued positively to be in contact with other patients, nurses and doctors in order to speak about their illness. Between 70% and 80% of the patients were satisfied with the infliximab treatment. After 2 weeks patients had reduced tender joint count by 70% and swollen joint count by 75%. At the end of the 14th week, 56.6% of the patients matched criteria ACR20, 31.5% ACR50 and 11.3% ACR70. 33.8% of patients had adverse events. The results in the EuroQol-5D indicated that patients improved their punctuations getting closer to those of the general population. Functional capacity of 50% of the patients improved significantly after the first 2 weeks of treatment and after 14 weeks this percentage reached the 70%., Conclusions: The results demonstrate that patients preferred to be treated in the hospital rather than in their houses. Also, patients reported a high level of satisfaction with infliximab.

Background and Objective: Although constipation affects quality of life, questionnaires hardly exist for its evaluation. We aimed to develop and validate a questionnaire able to measure the quality of life in patients with constipation., Patients and Method: A Spanish multicenter study was performed in 2 stages: a) questionnaire development (open interview to patients with constipation, pilot questionnaire, quantitative and factorial analysis, Rasch analysis, and specific questionnaire design), and b) questionnaire validation in 136 patients. These patients were divided in 2 groups: a) reliability group (n = 55; no need to begin or change treatment; re-tested after 15 days), and b) sensibility to change group (n = 81; need to begin or change treatment; re-tested after 3 months). We collected clinical and socio-demographic data and we evaluated the quality of life through the general questionnaire EuroQoL-5D (EQ-5D) and the specific one, design in the previous stage (25 items). After that, we analysed feasibility, reliability and validity (of content, convergent and longitudinal)., Results: The trial questionnaire was obtained during the development stage and the results were 51 items that were later reduced to 25 in the validation stage. A total of 126 patients (93% women; mean age [standard deviation]: 43.4 [1] years) completed the study properly. The answer average time was 12 min. The content validity process reduced the questionnaire to 20 items (CVE-20) within 4 domains: emotional, general physical, rectal physical and social. The reliability was good in relation to the general punctuation (Cronbach alpha coefficient = 0.87), being in the different domains of 0.79, 0.73, 0.75 and 0.60, respectively. The construct validity showed a good correlation between the CVE-20 results and constipation severity. The CVE-20 score positively correlated with EQ -5D changes. The test and re-test reliability were good: interclass correlation coefficient = 0.89 (ranging from 0.80 to 0.88 in the different domains). The clinically relevant and minimal difference was 17 points (95% confidence interval, 11-23). The content validity showed a strong correlation between CVE-20 and constipation severity., Conclusions: The CVE-20 is the first specific questionnaire in Spanish language for constipated patients; it is valid, reliable, sensitive to changes and it meets the psychometric requirements to be applied in daily practice and clinical trials.

Background and Objective: The aim of this study was to assess the measurement properties of the Spanish version of Asthma Control Questionnaire (ACQ) when FEV1 item in the original version (ACQ-FEV1) is substituted by peak expiratory flow rate (ACQ-PEF) and when the lung function item is omitted (ACQ-wLF)., Material and Method: and 607 patients were enrolled in this study. Three study visits were carried out: at baseline, 2, and 6 weeks later. Validity, reliability and sensitivity to change of both ACQ versions were calculated., Results: ACQ-PEF and ACQ-wLF had a correlation coefficient of 0.38 and 0.39 with no exacerbations. Both symptoms improvement and a better perception of asthma control, both by physicians and patients, were significantly related ro better scores in both versions (P <0.01). Cronbach a of ACQ-PEF and ACQ-wLF were 0.83 and 0.87, respectively. Intraclass correlation coefficients of both ACQ-PEF and ACQ-wLF were 0.9 and 0.87. Mean scores of all ACQ versions (ACQ-FEV1, ACQ-PEF and ACQ-wLF) were 1.31 (1), 1.34 (1) and 1.14 (1.1), respectively, being all differences statistically significant P < or = 0.003)., Conclusions: Replacement of FEV1 by PEF, or its elimination, does not alter the measurement properties of the ACQ questionnaire. Use of ACQ simplified versions is recommended only for investigational purposes, without combining in the same analysis scores obtained with different versions of the questionnaire.

Background and Objective: Lack of adherence to inhaled corticosteroid therapy is common in patients with asthma, and it has been suggested that allowing patients to choose their own inhalers would resolve this problem. The FSI-10 (Feeling of Satisfaction with Inhaler) is a self-completed questionnaire to assess patient opinions regarding ease or difficulty of use, portability, and usability of devices for delivery of inhaled corticosteroids. The aim of this study was to define the measurement properties of the FSI-10 questionnaire and to use this inventory to compare satisfaction and preferences of patients with asthma regarding 3 different devices for delivery of inhaled corticosteroids: Turbuhaler, Accuhaler, and Novolizer., Patients and Methods: We performed a multicenter, prospective, observational study in 112 stable asthmatic patients (64 women; mean [SD] age, 37 [22] years) treated on a regular basis with inhaled corticosteroids. The use of the devices was explained to the patients and the order in which they should be used in each case was randomly assigned. The devices were used for 7-day periods and at the end of each the FSI-10 questionnaire was completed for the device used. Once the protocol was completed, patients stated their preference for the different devices used., Results: The FSI-10 was easily understood and rapidly completed, and it exhibited acceptable measurement properties. Factor analysis showed that the measure was unidimensional. Although acceptance of all 3 devices assessed was reasonable, the FSI-10 questionnaire detected significant differences between them: Turbuhaler and Novolizer scored higher than Accuhaler on a number of questions. This preference is partly explained by Turbuhaler having been the device that was commonly used by the patients prior to the study. However, the highest scoring and most often preferred inhaler in patients under 16 years of age was the Novolizer, even though the Turbuhaler had also usually been used by those patients prior to the study., Conclusions: The FSI-10 is a useful instrument for assessing the degree of satisfaction of asthmatic patients regarding available inhalation devices. It is easy to understand and complete, and able to identify differences in patient satisfaction with the different inhalers.

Objectives: To estimate the prevalence of diagnosis of allergic asthma in patients with persistent asthma attending allergy or pneumology outpatient clinics and to describe the clinical management of asthma in these patients., Methods: Systematic random sampling was used to retrospectively include 382 patients aged between 12 and 65 years old with a diagnosis of persistent asthma (according to GINA criteria) who had attended allergy or pneumology outpatient clinics during the previous year. Allergic asthma was defined as the presence of sensitization to any common allergen according to the results of specific IgE determinations and/or skin tests. Data on the treatment of asthma were gathered., Results: Allergy studies were performed in 99.5% of the patients attending allergy centers and in 76.5% of those attending pneumology centers. A diagnosis of allergic asthma was made in 90.6% (95% CI: 86.5-94.7) and 46.1% (95% CI: 39.0-53.2), respectively. The prevalence of allergic asthma was highest in young male patients with less severe asthma. According to the GINA criteria, 14.1% of patients from allergy centres and 23.0% of those from pneumology centers were classified as having severe persistent asthma. Twenty-four percent of patients attending allergy clinics and 5.7% of those attending pneumology centers received bronchodilator treatment exclusively., Conclusions: Diagnosis of allergic asthma was much higher in allergy clinics than in pneumology centres. Although some of this difference may be due to more frequent performance of allergy studies in allergy clinics, the most probable explanation lies in the differences observed in the profiles of patients attending the two types of center.

Objective: The aim of this study was to develop and validate a specific tool to assess satisfaction with treatment in patients with rheumatoid arthritis (RA)., Material and Methods: The questionnaire was developed in three stages: firstly, a literature review was performed by experts in developing patient-centered measures; secondly, items selected by 4 experts in RA were assessed for comprehensibility, format and applicability, and thirdly, administration of the questionnaire was evaluated through a personal interview of a group of 14 patients with RA under treatment with infliximab. Validation of the questionnaire was performed in patients with RA who met the ACR criteria, were older than 18 years, and had started treatment with infliximab due to inadequate disease control. Questionnaires were administered at the baseline visit (beginning of treatment) and at 2, 6 and 14 weeks, coinciding with infliximab infusions. The questionnaire validity was evaluated in terms of construct validity (factorial analysis) and content validity. Content validity was assessed by analysing the relationship between satisfaction and different measures used for treatment effectiveness as well as fulfillment of treatment expectations., Results: Validation of the questionnaire was performed in a sample of 180 patients with a mean (SD) age of 52 (13) years. A total of 80.7% were women. In 72.4% disease duration was longer than 3 years. The scores obtained on the satisfaction questionnaire were related to the aspects defined as ACR criteria (except ESR and CRP), fulfillment of ACR20, ACR50 and ACR70 response criteria, and fulfillment of treatment expectations (p<0,01)., Discussion: The results confirm the questionnaire's validity in assessing patient satisfaction with RA treatment, both in routine clinical practice and in research conditions., (Copyright © 2006 Elsevier España S.L. Barcelona. Published by Elsevier Espana. All rights reserved.)

Introduction: Influenza is a major cause of morbidity and mortality worldwide. Currently, licensed influenza vaccines are safe and effective. Any intervention aimed at reducing the burden of illness is worth analyzing from a clinical and economic perspective., Objective: To assess the costs and benefits of an influenza vaccination program in the Spanish working population., Methods: A theoretical model of costs and benefits in terms of productivity savings was developed to compare 2 strategies (vaccination and non-vaccination) in 2 cohorts of 1,000 workers each. The time horizon was 1 year and the study's perspective was societal., Main Outcome Measures: epidemiological and clinical data on the incidence of influenza and the effectiveness of the vaccine. Data on the use of direct and indirect resources were obtained from an expert panel of 5 experts in preventive medicine, microbiology, occupational health, and health economics. Unit costs (euros 2003) were extracted from local databases. A sensitivity analysis was performed with the data on incidence, effectiveness, and work absenteeism due to influenza., Results: In the base case scenario, influenza vaccine saved 35 Euros per worker, of which 88% were savings in work loss days avoided. Threshold values in the sensitivity analysis were 6% for the incidence of influenza and 1.5 days for absence from work, above which the vaccine leads to net savings., Conclusions: Influenza vaccination in the Spanish working population might result in net resource savings to society at large.

Aim: To use a model of economic evaluation to analyse the efficiency of therapy with the antiepileptic drugs indicated in recently diagnosed partial and generalised epilepsy., Materials and Methods: The treatment of partial epilepsy and generalised epilepsy in Spain was taken as the basis to design two flexible simulation models of the decision tree type. The time horizon of the study was one year and the perspective was that of the Spanish National Health System, and indirect costs were also included. Clinical effectiveness data were obtained from a review of the literature on clinical trials. Information about resources was obtained from the opinions of a panel of experts. Unitary costs of resources were drawn from Spanish databases (euro 2003). The findings of the study were expressed in terms of average cost per patient with each therapeutic strategy, as well as the incremental cost of the different treatment strategies with respect to valproic acid., Results: According to the literature that was reviewed, there are no differences in effectiveness from one antiepileptic drug to another. The incremental cost of the different therapeutic strategies, with respect to valproic acid, lies between 211 and 911 euros per patient and year in partial epilepsy, and between 1,355 and 1,297 euros per patient and year in the case of generalised epilepsy., Conclusions: The use of sustained-release valproic acid in recently diagnosed partial and generalised epilepsy would allow savings to be made in resources, with respect to the other antiepileptic drugs, and can therefore be considered to be the most effective therapeutic option.

Introduction and Objectives: The CURE study showed that adding clopidogrel to standard therapy with acetylsalicylic acid reduces the risk of cardiovascular events (i.e., stroke, myocardial infarction, and cardiovascular death) in patients with acute coronary syndrome but without ST-segment elevation. The objective of this study was to carry out short- and long-term cost-effectiveness analyses of administering clopidogrel in addition to standard therapy during the first year of treatment., Patients and Method: For the short-term analysis, clinical data and information on health resource utilization were taken from the CURE study. For the long-term analysis, an adaptation of an internationally used Markov model involving six health states was employed. Clinical data were obtained from clinical trials and epidemiological studies. Information on resource use was obtained from two Spanish registries of patients with acute coronary syndrome, a literature review, and consultations with an expert panel. Results are expressed in terms of incremental cost per event avoided or per life-year gained., Results: In the short-term analysis, the incremental cost per event avoided of adding clopidogrel to standard therapy was ;17 190. In the long-term analysis, the incremental cost per life-year gained was ;8132, which is below the Spanish cost-effectiveness threshold of ;30 000 per life-year gained., Conclusions: Adding clopidogrel to standard therapy during the first year of treatment is cost-effective in both the short and long term.

Introduction: To assess the measurement properties of the Spanish version of the Psoriasis Disability Index (PDI) quality of life questionnaire for patients with moderate or severe psoriasis in ordinary clinical practice., Patients and Methods: A study was carried out with 294 patients with moderate or severe psoriasis who had received therapeutic treatment. Sociodemographic and clinical variables were collected and the PDI and EuroQoL-5D questionnaires were administered at the baseline visit, and at 3 and 6 months later. The feasibility (percentage of patients responding to the questionnaire), validity of the construct, internal reliability and sensitivity to change were analyzed., Results: Feasibility: 98.6 % of the patients answered over 80 % of the questions on the questionnaire. Validity of the construct: the PDI scores were correlated with the scores obtained in the Psoriasis Area Disability Index (PASI) (r = 0.33) and the Visual Analogue Scale (VAS) of the EQ-5D (r = -0.41) (p < 0.01). Longitudinal validity: the PDI questionnaire score after 6 months of treatment was correlated with the changes in the PASI index and the VAS (r = 0.39 y -0.51). Reliability: the internal consistency of the dimensions was high (Cronbach's alpha = 0.89). Sensitivity to changes: the size of the effect corresponding to the changes experienced by the patients who noticed an improvement in the severity of their psoriasis during the period between visits was 0.95., Conclusion: The Spanish version of the PDI has proven to be reliable, valid and sensitive to changes for use with patients with psoriasis in the Spanish population, although the test-retest reliability should be analyzed for clinically stable patients.

Background: Assessment of patient satisfaction with antiretroviral therapy is generating increasing interest in clinical practice, since the outcome is directly related with compliance with therapy and its effectiveness. Currently, there is no validated patient satisfaction questionnaire to evaluate this factor as related to control of the disease., Patients and Methods: An "ad hoc" questionnaire--Cuestionario Español de Satisfacción con el Tratamiento Antiretroviral (CESTA), Spanish Antiretroviral Treatment Satisfaction Questionnaire--was developed to evaluate satisfaction in patients switching to a simplified regimen. In a second phase, the questionnaire was validated in an observational study including 321 patients divided into two cohorts (patients switching to a simplified regimen and patients maintaining the same regimen)., Results: A total of 99% and 93% patients, respectively, completed the questionnaire at baseline and at the end-of-study visit. Cronbach's alpha coefficient for internal consistency and test-retest reliability were 0.82 and 0.69, respectively. Patients switching to a simplified regimen showed a statistically significant higher overall satisfaction score at the third-month visit than at baseline., Conclusions: The CESTA questionnaire is a valid instrument for use in clinical practice and provides valuable information on patient satisfaction with antiretroviral therapy.

Introduction: Although adverse events of triptans are usually not important from a clinical point of view, they can worry patients and lead them to consume healthcare resources., Methods: A decision analytic model was used to represent the behavior and management of patients who suffered adverse events after taking a triptan. Using data about the incidence of adverse events, the behavior and management of patients, and the unit cost of the healthcare resource consumed, the costs of treating adverse events were calculated, as was the iatrogenic cost factor of the triptans available in Spain., Results: 10 % to 20 % of patients who suffer a chest or CNS-related adverse advent related to triptan use seek medical attention. The management cost of a chest-related event was estimated to be euros 66,43, euros 33,09, or euros 137,01, depending on whether the patient consulted a neurologist, a primary care physician, or a hospital emergency department. For CNS-related events the management cost was estimated to be euros 52,88, euros 16,89 or euros 102,17, respectively. Excluding the placebo effect, the resulting iatrogenic cost factor varied between 1 for almotriptan 12,5 mg and 1,21 for zolmitriptan 2,5 mg. In absolute values, the average cost per patient (above placebo) varied between 0 euros for almotriptan 12,5 mg and euros 1,17 for eletriptan 80 mg., Conclusions: The management of adverse events can add substantial costs to a treatment with triptans. These costs vary considerably between triptans due to differences in the incidence of adverse events. Lowest costs were found for almotriptan 12,5 mg.

Objectives: The aim of this study was to assess the prevalence of the urinary symptoms suggestive of overactive bladder (OAB) in Spain based on the International Continence Society (ICS) 2002 consensus criteria as urinary urgency, with or without urge incontinence, usually with frequency and nocturia., Methods: 1,669 real telephone interviews were conducted to adults aged > or = 40 years. The sample size estimation was made according to the prevalence for OAB described in the Milsom paper stratified by age and gender due to the high variability observed between ranges. Appearance and prevalence of main OAB symptoms, medical diagnostic and therapy due to these symptoms data were collected., Results: the sample population was 1669 aged > or = 40 years, 50.6% women and 49.4% men. The overall prevalence of symptoms suggestive of OAB according to the OAB definition from ICS report 2002 was 21.5%, significantly higher in women (25.6%) than men (17.4%)(p<0.05). Adjusting these data to Spanish National Census of year 2000, the prevalence was 19.9%, being higher as well in women (23.6%) than men (115.4%). Urge urinary incontinence and stress urinary incontinence were superior in women (16.7% vs 10.4% and 33.1% vs 7.9% respectively)(p<0.01). Urinary frequency > 8 voids/day was referred by 9.8% of women and 7.9% of men interviewed. 62% of men and 52.4% of women reported they get up at night to void. A total of 52.1% of patients with urinary symptoms suggestive of overactive bladder reported they had consulted a doctor anytime before the interview due to urinary disorders and 16.7% was currently receiving treatment for some of these symptoms., Conclusions: Prevalence of urinary symptoms suggestive of Overactive Bladder is high in this study, in accordance with data from international studies. Urinary urgency, symptom which defines the pathology, is more prevalent in Spanish women than men. Further studies are needed to better assess OAB impact in the Spanish general population.

Background and Objective: We compared the safety and efficacy of liposomal amphotericin B with other formulations of amphotericin B and voriconazol as an empirical treatment of febrile neutropenia., Material and Method: Several randomized controlled clinical trials, designed to evaluate the safety and/or efficacy of liposomal amphotericin B in the empirical treatment of febrile neutropenia, in comparison with other amphotericin B formulations or voriconazol, were identified by means of a search in MEDLINE, EMBASE and Cochrane Controlled Trials Register's data bases. American Society of Microbiology and American Society of Clinical Oncology abstracts, presented between 1999 and 2002, were also included in the search. Prior to data extraction, concepts like nephrotoxicity, infusion-related adverse events and efficacy (success rate and mortality) were defined., Results: Two studies comparing liposomal amphotericin B with conventional amphotericin B, one comparing liposomal amphotericin B with amphotericin B lipid complex and one comparing liposomal amphotericin B with voriconazol were included in the analysis. Patients treated with liposomal amphotericin B had lower nephrotoxicity than patients treated with other amphotericin B formulations or with conventional amphotericin B (RR = 0.49); conversely, no statistically significant differences with regard to voriconazol were observed. In terms of efficacy, mortality rate and therapeutic failure, patients treated with limposomal amphotericin B showed a slightly higher efficacy., Conclusions: Liposomal amphotericin B is a lipidic formulation with a slightly higher efficacy than other amphotericin B formulations and voriconazol. In terms of nephrotoxicity, liposomal amphotericin B showed lower nephrotoxicity than other amphotericines while its safety rates were similar to those of voriconazol.

Objective: Validate the questionnaire Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in conditions of regular clinical practice., Methods: Two hundred and eighty four adult patients with a diagnosis of rhinoconjunctivitis (RC) cared in 37 centers of specialized health care in allergy or otorhinolaryngology services in Spain were analyzed. Patients with RC were included in two groups: clinically non-stable patients who received treatment with an oral second generation antihistaminic (group A), and clinically stable patients (group B). Sociodemographic and clinical variables were collected and the questionnaires RQLQ and EQ-5D were administered in the initial visit and in the second visit 15 days after. Feasibility, validity, reliability and sensitivity related to the change of the RQLQ were analyzed., Results: The mean period (standard deviation) of administration was 9.67 (6.25) minutes and 85.6% of patients needed assistance in order to fill the RQLQ, especially the selection of the characteristics (62.5%). The dimensions of the RQLQ showed a greater association with the dimensions of the EQ-5D that assessed similar aspects and the symptoms in which a greater relation was expected. The alpha Cronbach coefficient of the scorings of the RQLQ fluctuated between 0.85 and 0.96 and the intraclass correlation coefficient fluctuated between 0.68 and 0.89. The sensitivity to the change of the dimensions of the RQLQ, evaluated through the magnitude of the effect between the two visits, ranged between 0.76 and 1.46., Conclusions: The Spanish version of the RQLQ proved to be a valid instrument for assessing the Health-Related Quality of Life (HRQL) in adult patients with seasonal or perennial RC.

Introduction: The PROWESS clinical trial has shown that treatment with drotrecogin alpha (activated) in patients with severe sepsis is associated with a reduction in the absolute risk of death compared with standard treatment. The aim of the present study was to assess the cost-effectiveness of drotrecogin alpha (activated) versus that of standard care in the treatment of severe sepsis in Spain., Patients and Methods: A decision analysis model was drawn up to compare costs to hospital discharge and the long-term efficacy of drotrecogin alpha (activated) versus those of standard care in the treatment of severe sepsis in Spain from the perspective of the health care payer. Most of the information for creating the model was obtained from the PROWESS clinical trial. A two-fold baseline analysis was performed: a) for all patients included in the PROWESS clinical trial and b) for the patients with two or more organ failures. The major variables for clinical assessment were the reduction in mortality and years of life gained (YLG). Cost-effectiveness was expressed as cost per YLG. A sensitivity analysis was applied using 3% and 5% discount rates for YLG and by modifying the patterns of health care, intensive care unit costs, and life expectancy by initial co-morbidity and therapeutic efficacy of drotrecogin alpha (activated)., Results: Treatment with drotrecogin alfa (activated) was associated with a 6.0% drop in the absolute risk of death (p = 0.005) when all of the patients from the PROWESS trial were included and with a 7.3% reduction (p = 0.005) when the analysis was restricted to patients with two or more organ failures. The cost-effectiveness of drotrecogin alfa (activated) was 13,550 euros per YLG with respect to standard care after analysing all of the patients and 9,800 euros per YLG in the group of patients with two or more organ failures. In the sensitivity analysis, the results ranged from 7,322 to 16,493 euros per YLG. The factors with the greatest impact on the results were the change in the efficacy of drotrecogin alfa (activated), adjustment of survival by initial co-morbidity and the application of discount rates to YLG., Conclusions: Treatment with drotrecogin alfa (activated) presents a favorable cost-effectiveness ratio compared with other health care interventions commonly used in Spain.

Background and Objective: Our objective was to evaluate, through the health related quality of life (HRQoL) questionnaire MINICHAL, the influence of socio-demographic, clinical and therapeutic variables on health related quality of life of hypertensive patients., Patients and Method: An observational, prospective and multi-center study was carried out in hypertensive patients who were either starting or undergoing a modification of antihypertensive treatment. A total of three visits was done: a baseline visit and two follow-up visits at one and six months. At all three visits, several socio-demographic, clinical and therapeutic variables were recorded and HRQoL was measured using the MINICHAL questionnaire, the Spanish version of the Psychological General Well-Being Index, and a single question about the change in general health status. The objective was to evaluate the impact of these variables on HRQoL., Results: 736 patients with hypertension were evaluated. In the multivariate analysis, gender, number of concomitant diseases, degree of hypertension, organ damage and educational level were all variables displaying a relation with HRQoL. After 6 months of treatment intensification, an improvement of HRQoL was observed. Moreover, a positive correlation was observed between the degree of reduction of blood pressure (BP) and heart rate and HRQoL improvement, especially in the State of mind dimension., Conclusions: In hypertension, a better BP control has a positive influence on HRQoL. As several clinical variables are negatively correlated with HRQoL, specific interventions are needed to correct modifiable factors.

Background and Objective: Our goal was to validate the Spanish version of the Brief Pain Inventory (BPI) questionnaire used to measure the intensity of oncological pain and its impact on activities of daily living in patients with cancer., Patients and Method: Patients with oncological pain were consecutively included in the study. These patients filled up the Spanish version of the BPI questionnaire (CBD) and the Rotterdam Symptom Checklist (RCSL) during the inclusion visit and again after 3-5 days (patients with clinically stable oncological pain) or after one month (patients with unstable oncological pain)., Results: 126 patients were assessed; 85.1% of them had suffered some episode of irruptive pain 24 hours prior to their inclusion in the study. 86.5% of patients fully completed the questionnaire. The CBD showed mild to moderate correlations with the patients perception of pain severity and with the presence of tumor dissemination. The <> dimension of the RCSL displayed the highest correlation with the dimensions of the BPI (<> and <>). The internal consistency and the test-retest reliability between dimensions were good (0.87 and 0.89) and low to moderate (0.53 and 0.77), respectively. The CBD questionnaire was found to be a tool capable of detecting changes in pain intensity. The changes observed in the two CBD dimensions between study visits fairly reflected the patients perceived changes in pain intensity., Conclusions: The Spanish version of BPI is valid for measuring the intensity of oncological pain and its impact on activities of daily living in conditions of usual clinical practice.

Background: Affective and anxiety disorders (AfD & AnD) are the most common psychiatric diseases in the general population. This study's aim was to assess for the first time the psychometric properties of the Spanish translated versions of the Montgomery-Asberg Depression Rating Scale (MADRS) and the Hamilton Anxiety Rating Scale (HARS), which are widely used both in medical care and clinical research., Patients and Method: A cohort, observational, prospective and multicentre study was conducted in clinically stable or unstable patients with AfD and AnD. The scales were administered at baseline and in a second study visit one week or 2 months later (to stable or unstable patients, respectively). The internal consistency, temporary stability, inter-raters reliability, factorial structure, convergent and discriminant validity, and sensitivity to change were all assessed for both scales., Results: One hundred and eight AfD patients and 106 AnD patients were recruited in 10 psychiatry care centres from a wide geographical distribution. Both scales showed adequate properties in terms of: a) discriminant validity (MADRS/HARS-Clinical Global Impression: p < 0.001); b) convergent validity (MADRS-Hamilton Depression Rating Scale: p < 0.05 and 0.01; MADRS/HARS-EuroQoL 5D: p < 0.05; HARS-State Trait Anxiety Inventory: p < 0.05); c) internal consistency (Cronbach's alpha: MADRS = 0.88; HARS = 0.89); d) test-retest and inter-raters reliability (intraclass correlation coefficient: MADRS = 0.94 and 0.98, respectively; HARS = 0.92 and 0.92), and, e) sensitivity to change (effect size: MADRS = 2.05; HARS = 1.36)., Conclusions: Spanish versions of MADRS and HARS scales showed good psychometric properties, similar to those of the original scales. Therefore, these scales are suitable for use in clinical practice and research in Spain.

Background: To analyze the clinical utility of the quality of life questionnaire for asthmatic children (PAQLQ) and to validate it for use in clinical practice., Patients and Method: 1,012 children between 6 and 14 years of age, with a diagnosis of mild to moderate asthma attending 48 Spanish hospitals were included in the study. The patients' socio-demographic and clinical characteristics were recorded and all patients were administered the PAQLQ and EQ-5D questionnaires on two occasions: at the baseline visit and at 2-3 months from baseline in patients with uncontrolled asthma(group A) and at baseline and 15 days from baseline in patients with controlled asthma (group B). The feasibility, validity, reliability and sensitivity to change of the PAQLQ were assessed., Results: The PAQLQ proved to be feasible for use in children over 7 years of age with mild or moderate asthma. The PAQLQ did not show a statistically significant relationship with socio-demographic variables, nor with the majority of clinical variables, with the exception of asthma severity, number of exacerbations, symptoms and use ofon- demand short-term beta2 agonist drugs. Correlations between PAQLQ and EQ-5D dimensions were strongest between dimensions measuring similar attributes. Cronbach's *coefficients for the PAQLQ ranged from 0.88 for the limitations in activities dimension to 0.96 for the overall score. The intraclass correlation coefficient for PAQLQscores in group B ranged from 0.71 (limitation of activities)to 0.83 (overall score). The effect size between both visits ranged from 0.49 to 0.69., Conclusions: The Spanish version of the PAQLQ proved to be valid for use in children with mild to moderate asthma.

Background: The use of currently validated instruments to measure the health-related quality of life (HRQoL) of patients with osteoporosis in daily clinical practice is not feasible due to the length of time needed to be administered. The objective of the present study was to develop a new, short questionnaire for women with vertebral fractures due to osteoporosis., Patients and Methods: The administration of two disease-specific questionnaires (OQLQ and QUALEFFO) and the generic SF-36 questionnaire to 338 women with vertebral fracture due to osteoporosis allowed the development of a new questionnaire in 5 stages: i) search for a common structure in both questionnaires; ii) independent reduction of items in the OQLQ and QUALEFFO using Rasch analysis; iii) aggregation of remaining items in both questionnaires into distinct dimensions; iv) quantitative reduction of redundant items in aggregated dimensions; v) qualitative item reduction in aggregated scales., Results: The methodology of the study allowed the development of a 16 item questionnaire (ECOS-16), with 4 items taken from the OQLQ and 12 from the QUALEFFO. The items are grouped into 4 categories: physical functioning (5 items), illness-related fears (2 items), psychosocial functioning (4 items), and pain (5 items)., Conclusions: The ECOS-16 will be a promising alternative, once it is validated, to generic questionnaires and to the specific questionnaires from which its content was extracted, particularly for patients with osteoporotic vertebral fracture in daily clinical practice.

Background: Assessment of cost and effectiveness in highly active antiretroviral therapy (HAART) in HIV asymptomatic patients., Patients and Methods: A cohort of several asymptomatic HIV-infected patients were observed under real practice and treated with two nucleosid analogues (AN) of which therapy was modified. A protease inhibitor (PI) was added and at least one AN was changed (or not), following the current clinical recommendations (1997). Data on direct cost (drug cost, visits and clinical procedures) were then recorded both three and six months after the beginning of the study. Data on effectiveness (percentage of patients with undetectable levels of viral load) and quality of life were next measured according to the EuroQol, and recorded at the same time. All patients used a monthly diary to keep record of resource consumption and quality of life progress., Results: All treatment regimens were effective in lowering the viral load and improve quality of life. The less expensive HAART was AZT + 3TC + IND (1,037,757 pesetas) and AZT + ddl + IND (1,045,339 pesetas), but both were the least effective to reduce patient's viral load to undetectable levels (52.7 and 57.7% respectively); meanwhile d4T + 3TC + IND (1,188,177 pesetas) and d4T + ddl + IND (1,212,285 pesetas) were more expensive but more effective (67.9 and 66% respectively). Cost-effectiveness ratios ranged between 9,896 and 13,122 pesetas. There was no statistically significant differences in quality of life among the different HAART regimens., Conclusions: HAART implementation is effective in reducing patients' viral load to undetectable levels and to slightly improve their quality of life after six months. Costs and effectiveness vary according to the type of HAART treatment used.

Health outcomes research (HOR) is an important source of knowledge regarding the effectiveness of health care treatments and interventions which focus on providing benefits in terms of those results which are important for patients. Medical research has traditionally focussed on the measurement of clinical variables, such as symptoms or laboratory tests, as a means of determining the results of medical interventions. Although HOR uses such tests, it also places great emphasis on the use of other measures such as health-related quality of life, satisfaction with treatment, and cost-effectiveness. The results obtained should be incorporated in the evaluative process and in disease management to determine the effectiveness of health care services in improving the population's health.

Objectives: To undertake an economic evaluation of three strategies for diagnosing and treating Helicobacter pylori (HP)-related peptic ulcers (PU), and to find the most efficacious and efficient combination of medication for the most cost-effective strategy., Design: Cost-effectiveness analysis based on retrospective information (systematic review of the literature) and Markov models for the simulation of a hypothetical cohort of patients with PU., Patients: Patients seeking medical care at the primary level for an acute PU attack. The costs and health effects of the management of an attack were evaluated in a hypothetical cohort of adults (> 18 years old) with symptomatic peptic ulcer confirmed endoscopically and not associated with consumption of non-steroidal anti-inflammatory drugs (NSAIDs)., Interventions: Three strategies for handling PU patients were compared: pre- and post-treatment diagnosis of HP, pre-treatment diagnosis and empirical treatment. Then the most efficient strategy for comparing 6 combinations of antibiotics was used., Results: The empirical treatment strategy was markedly less costly (saving of between 15000 and 39000 pesetas per patient treated) than the diagnosis strategies, and obtained equivalent effectiveness under all analytical hypotheses. In comparing drug combinations, the classic triple therapies based on bismuth subcitrate were more effective and less costly than other therapies., Conclusions: Empirical treatment with combinations of irradicatory drugs was the most efficient strategy for tackling the diagnosis/therapy of patients with HP-related PU. In terms of efficiency, the choice between the various combinations of irradicatory drugs with over 80% success depends basically on the cost of the drugs.

Background: To introduce the EuroQol 5D (EQ-5D) to health care professionals wishing to use it as a measure of health-related quality of life., Methods: This paper is based on a review of studies using the EQ-5D in Spanish populations which include chronic and critical patients, health care users, and random samples of the general population in Navarra and Catalonia., Results: Results are presented for three aspects of the EQ-5D: the descriptive system, the visual analogic scale, and the EQ-5D tariff. Presence of problems on the descriptive system and lower scores on the visual analogue scale were positively associated with increasing age, being female, lower educational level and social class, presence of chronic conditions, higher levels of restricted activity, visits to a health care professional in the previous 15 days, and hospitalisation during the previous year. The ability of the descriptive system and the visual analogic scale to discriminate between healthy individuals and critical and chronic patients was good. Social tariffs for EQ-5D health states have been obtained based on self-rated health and the rating of hypothetical health states (health states not experienced by the rater). Tariffs for hypothetical health states have been obtained using visual analogic scale and time trade-off techniques. Tariffs also discriminate between healthy and non-healthy subjects, and are a valid reflection of preferences for health states., Conclusions: The Spanish version of the EQ-5D is a simple, valid and practical measure for its use as an outcome variable both in clinical research and in the allocation of health care resources:

Background: The number of professional diseases (PD) declared in Spain is low. The existence of diseases of labor etiology treated as a common disease is recognized, thus disregarding important labor health risks., Methods: The incidence of PD in the province of Barcelona from 1987-1991 was prospectively studied by the Units of Medical Evaluation of Incapacities (UMEI). The sociodemographic, medical and administrative data of the cases of PD were reported by a protocol of data collection. The cases of PD are described and the annual incidence in relation with the active working population calculated., Results: The UMEI of Barcelona confirmed 554 cases of PD of which 331 were evaluated as permanent invalidity over the five years of the study. The most frequent diagnoses of PD were pneumoconiosis, skin diseases, diseases causing tendinous fatigue and hypoacusis or deafness. Eleven neoplasms were reported, 9 being caused by asbestos. During the five years the incidence of PD increased from 76 cases to 144 per 100,000 active workers. The procedure of information probably underreported the incidence of PD., Conclusions: A low incidence of professional disease was observed. The clinical-labor history is generally not carried out. The way in which the Units of Medical Evaluation of Incapacities report data concerning incidence may contribute to greater detection of professional diseases on registration being integrated into a system of epidemiologic surveillance in which all the health care, labor and administrative centers were effectively coordinated.