[Incidence and burden of illness in postoperative paralytic ileus in Spain].
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Biomedical subjects
Publications and source records attributed to Xavier Badia.
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OBJECTIVE: To determine whether impaired quality of life (QoL) in adults with GH deficiency (GHD) is reversible with long-term GH therapy and whether the responses in QoL dimensions differ from each other. METHODS: QoL was measured by the Quality of Life-Assessment for Growth Hormone Deficiency in Adults (QoL-AGHDA) in general population samples in England & Wales, The Netherlands, Spain and Sweden (n = 892, 1038, 868 and 1682 respectively) and compared with corresponding patients' data from KIMS (Pfizer International Metabolic Database) (n = 758, 247, 197 and 484 respectively) for 4-6 years a follow-up. The subsets of patients from England and Wales, and Sweden with longitudinal data for 5 years' follow-up were also analysed. The change of the total QoL-AGHDA scores and responses within dimensions were evaluated. Subanalyses were performed to identify any specificity in response pattern for gender, age, disease-onset and aetiology. RESULTS: Irrespective of the degree of impairment, overall QoL improved dramatically in the first 12 months, with steady progress thereafter towards the country-specific population mean. Problems with memory and tiredness were the most serious burden for untreated patients, followed by tenseness, self-confidence and problems with socialising. With treatment, these improved in the reverse order, normalising for the latter three. CONCLUSIONS: Long-term GH replacement results in sustained improvements towards the normative country-specific values in overall QoL and in most impaired dimensions. The lasting improvement and almost identical pattern of response in each patient subgroup and independent of the level of QoL impairment support the hypothesis that GHD may cause these patients' psychological problems.
OBJECTIVE: Validate the acromegaly quality of life (AcroQoL) questionnaire as a disease-generated questionnaire, which analyses physical and psychological domains, the latter subdivided into appearance and personal relationship sub-scales, to evaluate health-related quality of life (HRQoL) in acromegaly. DESIGN: Prospective, observational multicenter study. METHODS: One hundred and six patients with acromegaly, 42 with active disease studied basally and 6 months after treatment ('sensitivity to change' group), and 64 with treated, stable disease, studied twice within 1 month ('reliability' group) were included. As controls, a reference Spanish population (n=12,245 for the EuroQoL questionnaire) and 157 obese patients (body mass index>30 kg/m2) were studied basally. Socio-demographic data, clinical activity, co-morbidity, GH, IGF-I, and HRQoL (overall perception of health state, EuroQoL and AcroQoL in the obese controls and acromegalic patients) were evaluated. RESULTS: Globally, AcroQoL scored worse in the 'sensitivity to change' group than in the 'reliability' group (56+/-20 vs 65+/-18, P<0.05), but did not discriminate between patients and obese controls. The psychological domain was worse in the 'sensitivity to change' group than obese controls (P<0.05). Appearance was the most affected sub-scale in acromegaly and significantly worse than in obese controls. The sub-scale personal relationships of AcroQoL were less affected in the 'reliability' group than in obese controls (P<0.05). Patients with acromegaly and obese controls showed more problems on the EuroQoL than general Spanish population. Significant correlations were observed globally and for each dimension between AcroQoL and the generic questionnaires. On re-testing, no change was observed in the 'reliability' group in any questionnaire, demonstrating good test-re-test reliability. In the 'sensitivity to change' group after 6 months of treatment, there was improvement in the generic questionnaires and in AcroQoL score (P<0.01). Internal consistency of AcroQoL was good (Cronbach's alpha>0.7). No correlation between AcroQoL and GH or IGF-I was observed. CONCLUSION: AcroQoL questionnaire is a valid tool for the assessment of HRQoL in clinical practice in patients with acromegaly.
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BACKGROUND: Anogenital warts are the most easily recognized sign of genital Human Papilloma Virus infection. The objective was to develop a short, valid and reliable questionnaire to measure Health Related Quality of Life (HRQL) in patients with anogenital warts. METHODS: First a literature review was performed to identify relevant papers describing the impact of anogenital warts in HRQL; second the main domains were identified by some experts in a focus group, and third in-depth-semi-structured interviews were conducted in patients with anogenital warts to identify the initial set of items. A qualitative reduction of the initial set of items was performed based on the mean scoring of the experts for the three scales: clarity, frequency and importance. The initial questionnaire was pilot tested in 135 patients. Rasch analysis was performed with the results of the questionnaire in order to refine the instrument. Spearman's correlation was calculated between the initial questionnaire and the reduced version. Additionally the measurement properties (validity and reliability) of the resulting final questionnaire were tested and compared using standard procedures (Cronbach's Alpha and item-total correlation). RESULTS: the main domains identified as affected in patient's life were: sexual, colleagues and partner relationships. After a proper qualitative reduction the initial set of 134 items was reduced to 22. The questionnaire was pilot tested in 135 patients and two dimensions were identified after the multifactorial analysis: emotional dimension and sexual activity dimension. As a result of the Rasch analysis the questionnaire was reduced to 10 items. High correlation was found between the initial and the reduced version for the two dimensions. Cronbach's alpha values were acceptable (0.86). CONCLUSION: The initial 22 items questionnaire was reduced by Rasch analysis to a version of 10 items, with two dimensions: emotional and sexual. The results suggest the adequacy of the 10 items to evaluate HRQL of patients with anogenital warts in a valid and reliable way.
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.
The study aims to assess the effectiveness of an educational leaflet in the prevention of external genital warts recurrences after achieving clearance with topical immune response modifiers treatment. A six-month follow-up, prospective, open, multi-centre randomized by centres study was conducted, which included a total of 216 patients. A total of 103 (47.7%) patients were given an educational leaflet. In all, 201 subjects (93.1%) came to the second follow-up visit, of which 62.7% achieved condyloma acuminatum (CA) clearance. During follow-up, 15% (confidence intervals [CI] 95%, 7.1-26.6%) of the patients who were given the educational leaflet, and 33.3% (CI 95%, 20.4-48.4%) of those who were not given the educational leaflet showed CA recurrences; the global rate of CA recurrence at the end of the six-month follow-up was 23.1% (CI 95%, 15.6-32.2%). The educational leaflet has therefore proved to be effective at reducing the recurrence rate after successful treatment with immune response modifiers.
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.
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.
BACKGROUND: The aim of this study is to validate the questionnaire ECOS-16 (Assessment of health related quality of life in osteoporosis) for the evaluation of health related quality of life (HRQoL) in post-menopausal women with osteoporosis. METHODS: An observational, prospective and multi-centre study was carried out among post-menopausal women with osteoporosis in primary care centres and hospital outpatient clinics. All patients attended 2 visits: at baseline and at 6 months. In addition, the subgroup of outpatients attended another visit a month after the baseline to assess the test-retest reliability. The psychometric properties of the questionnaire were evaluated in terms of feasibility, validity (content validity and construct validity) and internal consistency in baseline, and in terms of test-retest reliability and responsiveness to change in visit at month and visit at 6 months, respectively. In all visits, ECOS-16, EUROQoL-5D (EQ-5D) and four 7-point items about health status (general health status, back pain, limitation in daily activities and emotional status) were administered, whereas only outpatients were given MINI-OQLQ (Mini Osteoporosis Quality of Life Questionnaire), besides all clinical variables; and sociodemographic variables at baseline. RESULTS: 316 women were consecutively included, 212 from primary care centres and 104 from hospital outpatient clinics. Feasibility: 94.3% of patients answered all items of the questionnaire. The mean administration time was 12.3 minutes. VALIDITY: factor analysis suggested that the questionnaire was unidimensional. In the multivariate analysis, patients with vertebral fractures, co-morbidity and a lower education level showed to have worse HRQoL. Moderate to high correlations were found between the ECOS-16 score and the other health status questionnaires (0.47-0.82). Reliability: internal consistency (Cronbach's alpha) was 0.92 and test-retest reliability (ICC) was 0.80. Responsiveness to change: ECOS-16 scores increased according to change perceived by the patient, as well as the effect size (ranges between 1.35 to 0.43), the greater the perception of change in patients' general health status, the greater the changes in patients' scores. The Minimal Clinically Important Difference (MCID) suggested a change of 0.5 points in the ECOS-16 score, representing the least improvement in general health status due to their osteoporosis: "slightly better". CONCLUSION: ECOS-16 has been proven preliminarily to have good psychometric properties, so that it can be potentially a useful tool to evaluate HRQoL of post-menopausal women with osteoporosis in research and routine clinical practice.
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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.
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Acromegaly is a chronic disease with an important impact on patients, Health Related Quality of Life (HRQoL). The ability to effectively measure Health Related Quality of Life is central to describing the impacts of disease or treatment upon the patient, therefore the importance of having a disease specific questionnaire for acromegaly. For the development of the AcroQoL questionnaire different sources of information were used: first a literature search was performed to identify relevant papers describing the impact of acromegaly in HRQoL, second the main domains of impact on HRQoL were identified by 10 experts endocrinologists, and third ten in-depth semi-structured interviews were conducted in acromegalic patients to identify domains and items related to the self-perceived impact of acromegaly in patients' life. After a proper qualitative analysis a preliminary 38 item questionnaire was obtained. Rasch analysis concluded with a final 22 item questionnaire. The measurement properties (validity and reliability) of the resulting final questionnaire were tested and compared using standard procedures (Cronbach's Alpha and item-total correlation). The evaluation of the item parameters confirmed the construct validity of the new instrument. Responsiveness to change was assessed in a small sample of 32 acromegalic patients with active disease in Spain who were administered the AcroQoL and the generic questionnaire EuroQoL 5-D. The results showed a statistically significant relationship between all the dimensions of AcroQoL and the VAS (visual analogic scale) of EQ-5D. An improvement in the global score of AcroQoL was related to a global improvement in the VAS of the EQ-5D. Following the current recommended standard methodology the Spanish questionnaire was translated into eleven other languages.
Symptoms of incontinence are common, particularly among older people, and incontinence can have a severe effect on the quality of life of some individuals at any age. A number of treatments are available, most of which aim to reduce the occurrence of incontinent episodes or to limit the effects of the disorder on everyday life. In research and clinical practice, it is essential that the symptoms and effects of incontinence be properly assessed and recorded. The only valid means of measuring patients' perspectives is through the use of psychometrically robust self-report questionnaires. Incontinence may be experienced as part of the symptom complex of a range of conditions (e.g., benign prostatic diseases or fistulas), and the effect of incontinence on quality of life varies depending on the severity of the condition and other psychosocial and medical factors. Questionnaires with acceptable levels of psychometric testing are identified and recommended for use in clinical practice and research investigations according to the following categories: (1) questionnaires to assess symptoms of incontinence, (2) generic health-related quality-of-life questionnaires to assess the effect of incontinence on quality of life, and (3) incontinence-specific measures to assess the effect and bothersomeness of incontinence on quality of life.
BACKGROUND: Despite the growing use of statins, many hypercholesterolaemic patients fail to reach their lipid goal and remain at elevated risk of coronary heart disease (CHD). Alternative treatment strategies, such as ezetimibe coadministration and statin titration, can help patients achieve greater lipid control, and thereby lower their CHD risk. But is it cost effective to more aggressively lower cholesterol levels across a broad range of current statin users? METHODS: Using a decision-analytic model based on epidemiological and clinical trials data, we project the lifetime benefit and cost of alternative lipid-lowering treatment strategies for CHD and non-CHD diabetic patients in Germany, Spain and Norway. RESULTS: It is projected that from 40% to 76% of these patients who have failed to reach their lipid goal with their current statin treatment will be able to reach their goal with ezetimibe coadministration; this represents a gain of up to an additional absolute 14% who will be able to reach their goal compared with a 'titrate to goal' strategy where patients are titrated in order to reach their lipid goal (up to the maximum approved dose). For CHD patients, the estimated incremental cost-effectiveness ratio for ezetimibe coadministration is under Euro 18 000 per life-year gained (Euro/LYG) and 26 000 Euro/LYG compared with strategies based on the observed titration rates and the aggressive 'titrate to goal' strategy, respectively; for non-CHD diabetic patients, these ratios are under 26 000 Euro/LYG and 48 000 Euro/LYG for ezetimibe coadministration compared with the two titration strategies. CONCLUSION: Compared with statin titration, ezetimibe coadministration is projected to be cost effective in the populations and countries studied.