A systematic literature review and expert consensus on risk factors associated to infection progression in adult patients with respiratory tract or rectal colonisation by carbapenem-resistant Gram-negative bacteria.

OBJECTIVE: Risk factors (RFs) associated with infection progression in patients already colonised by carbapenem-resistant Gram-negative bacteria (CRGNB) have been addressed in few and disperse works. The aim of this study is to identify the relevant RFs associated to infection progression in patients with respiratory tract or rectal colonisation. METHODS: A systematic literature review was developed to identify RFs associated with infection progression in patients with CRGNB respiratory tract or rectal colonisation. Identified RFs were then evaluated and discussed by the expert panel to identify those that are relevant according to the evidence and expert's experience. RESULTS: A total of 8 articles were included for the CRGNB respiratory tract colonisation and 21 for CRGNB rectal colonisation, identifying 19 RFs associated with pneumonia development and 44 RFs associated with infection progression, respectively. After discussion, the experts agreed on 13 RFs to be associated with pneumonia development after respiratory tract CRGNB colonisation and 33 RFs to be associated with infection progression after rectal CRGNB colonisation. Respiratory tract and rectal colonisation, previous stay in the ICU and longer stay in the ICU were classified as relevant RF independently of the pathogen and site of colonisation. Previous exposure to antibiotic therapy or previous carbapenem use were also common relevant RF for patients with CRGNB respiratory tract and rectal colonisation. CONCLUSIONS: The results of this study may contribute to the early identification of CRGNB colonized patients at higher risk of infection development, favouring time-to-effective therapy and improving health outcomes.

[A systematic review and expert's analysis of risk factors of infections in adults due to carbapenem-resistant Pseudomonas aeruginosa or Acinetobacter baumannii in Spain]. / Revisión sistemática de la literatura y análisis de expertos sobre los factores de riesgo asociados a infecciones causadas por Pseudomonas aeruginosa o Acinetobacter baumannii resistentes a carbapenémicos en pacientes adultos en España.

OBJECTIVE: The aim of the study is to identify risk factors associated to infections caused by carbapenem-resistant Pseudomonas aeruginosa (CRPA) and carbapenem-resistant Acinetobacter baumannii (CRAB) in adult patients through a systematic literature review, classify them according to their importance and provide recommendations by experts in the Spanish context. METHODS: We developed a systematic literature review to identify risk factors associated to CRPA or CRAB infections and they were evaluated and discussed by a multidisciplinary panel of experts. RESULTS: There were included 29 studies for P. aeruginosa and 23 for A. baumannii out of 593 identified through systematic literature review. We identified 38 risk factors for P. aeruginosa and 36 for A. baumannii. After risk factor evaluation by the panel of experts, results for CRPA were: 11 important, 10 slightly important and 15 unimportant risk factors; and for CRAB were: 9 important, 5 slightly important and 19 unimportant risk factors. For both pathogens, previous use of antibiotics and hospitalization were important risk factors. CONCLUSIONS: We could identify the main risk factors associated to CRPA and CRAB through literature review. There is a need for developing additional studies with higher levels of evidence to identify sooner and better infected patients through associated risk factors.

The burden of cancer in Spain.

INTRODUCTION: Cancer imposes a huge financial burden in all developed countries. This study estimates the burden of cancer in Spain in 2015. METHODS: The most recent available epidemiological data on prevalence, incidence and mortality, and the economic data on direct (hospital, drugs, and primary care) and indirect (productivity) costs was used from the social perspective. RESULTS: Prevalence, incidence, and mortality were, respectively, 1240, 478, and 218 per 100,000 inhabitants. Mortality was higher for men, while disability rates were higher for women. Direct costs accounted for 4818 million euros and indirect costs were 640 million euros in 2015. Direct costs were almost completely borne by the hospital (94%). Total burden of cancer in Spain was 5458 million euros in 2015. CONCLUSIONS: In Spain, the costs of cancer were mainly borne by the hospital and these costs might increase in the future due to the expected increase in longevity. Further research would be needed to investigate whether it is possible to redistribute the economic burden of cancer.

Validation of PHPQoL, a Disease-Specific Quality-of-Life Questionnaire for Patients With Primary Hyperparathyroidism.

CONTEXT: Health-related quality of life (HRQoL) is impaired in primary hyperparathyroidism (PHPT) but instruments to specifically assess this are scarce. OBJECTIVE: Validate the new disease-specific Primary Hyperparathyroidism Quality of Life (PHPQoL) questionnaire in usual clinical practice. DESIGN: Observational, prospective, and multicenter. SETTING: Public hospital ambulatory care. PATIENTS: Patients with PHPT of both sexes, aged more than or equal to 18 years either initiated treatment for PHPT (group A) or had stable PHPT, not requiring therapy (group B). Patients in group A had at least one surgical criterion according to the 2009 Third International Workshop on Management of Asymptomatic PHPT. INTERVENTION: Sociodemographic, clinical, and HRQoL data (PHPQol, Short Form-36, Psychological Well-Being Index, and patients' self-perceived health status) were collected. Group A underwent 4 evaluations (baseline, 3 ± 1, 6 ± 1, and 12 ± 2 months after a therapeutic intervention) and group B 2, at baseline and 1 month later to assess test-retest reliability. RESULTS: A total of 182 patients were included (104 group A, 78 group B) with a mean age (SD) of 61.4 (12.1) years; 79.7% were women. Group A increased PHPQoL score (SD) (better HRQoL) (52 ± 23 at baseline; 62 ± 24 at 12 months; P < .001). At baseline, symptomatic patients had a lower PHPQoL score (worse) than asymptomatic ones (51 ± 21 vs 68 ± 21; P < .001). Correlations were seen between PHPQoL and Short Form-36, Psychological Well-Being Index, and self-perceived health status (P < .001). PHPQoL had good internal consistency (Cronbach's α = 0.80), test-retest reliability (group B, intraclass correlation coefficient > 0.80), and sensitivity to detect HQRoL changes over time. CONCLUSIONS: PHPQoL is a valid HRQoL measure to assess the impact of PHPT on health perception in clinical practice.

Does the COPD assessment test (CAT(TM)) questionnaire produce similar results when self- or interviewer administered?

PURPOSE: The COPD assessment test (CAT) is a questionnaire that assesses the impact of chronic obstructive pulmonary disease (COPD) on health status, but some patients have difficulties filling it up by themselves. We examined whether the mode of administration of the Spanish version of CAT (self vs. interviewer) influences its scores and/or psychometric properties. METHODS: Observational, prospective study in 49 Spanish centers that includes clinically stable COPD patients (n = 153) and patients hospitalized because of an exacerbation (ECOPD; n = 224). The CAT was self-administered (CAT-SA) or administered by an interviewer (CAT-IA) based on the investigator judgment of the patient's capacity. To assess convergent validity, the Saint George's Respiratory Disease Questionnaire (SGRQ) and the London Chest Activity of Daily Living (LCADL) instrument were also administered. Psychometric properties were compared across modes of administration. RESULTS: A total of 118 patients (31 %) completed the CAT-SA and 259 (69 %) CAT-IA. Multiple regression analysis showed that mode of administration did not affect CAT scores. The CAT showed excellent psychometric properties in both modes of administration. Internal consistency coefficients (Cronbach's alpha) were high (0.86 for CAT-SA and 0.85 for CAT-IA) as was test-retest reliability (intraclass correlation coefficients of 0.83 for CAT-SA and CAT-IA). Correlations with SGRQ and LCADL were moderate to strong both in CAT-SA and CAT-IA, indicating good convergent validity. Similar results were observed when testing longitudinal validity. CONCLUSIONS: The mode of administration does not influence CAT scores or its psychometric properties. Hence, both modes of administration can be used in clinical practice depending on the physician judgment of patient's capacity.

Disease-specific quality of life evaluation and its determinants in Cushing's syndrome: what have we learnt?

Cushing's syndrome (CS) has a considerable negative impact on patient health-related quality of life (HRQoL). Two disease-specific instruments (the CushingQoL and the Tuebingen CD-25 questionnaire) are now available to assess the impact of the disease and its treatment on HRQoL. The purpose of this review was to summarize the characteristics of the studies which have used these two instruments to date and summarize their findings regarding (a) the determinants of disease-specific HRQoL in patients with CS and (b) the impact of treatment for CS on disease-specific HRQoL. A total of 7 studies were identified, 5 with the CushingQoL and 2 with the Tuebingen CD-25. Most were observational studies, though the CushingQoL had been used in one randomized clinical trial. In terms of clinical factors, there was some evidence for an association between UFC levels and disease-specific HRQoL, though the presence and strength of the association varied between studies. There was also some evidence that a more recent diagnosis of CS could lead to poorer HRQoL, and that length of time with adrenal insufficiency may also affect HRQoL. There was no evidence for an impact on disease-specific HRQoL of etiology or of the clinical signs and symptoms associated with CS, such as bruising, rubor, and fat deposits. One factor which did have a significant negative effect on HRQoL was the presence of depression. No clear picture emerged as to the effect of demographic variables such as age and gender on HRQoL scores, though there was some evidence for poorer HRQoL in female patients. As regards treatment, the two interventions studied to date (transsphenoidal surgery and pasireotide) both showed significant gains in HRQoL, with moderate to large effect sizes. This type of review is useful in summarizing knowledge to date and suggesting future research directions.

Health care costs of complex perianal fistula in Crohn's disease.

AIM: To evaluate the use of health care resources and the associated costs of complex perianal Crohn's disease (CD) from the National Health System perspective. METHODS: We conducted a multicenter, retrospective, observational study in which gastroenterologists from 11 hospitals in the Community of Madrid took part. Data was collected on the direct healthcare resources (pharmacological treatments, surgical procedures, laboratory/diagnostic tests, visits to specialists and emergency departments, and hospitalizations) consumed by 97 adult patients with complex perianal CD which was active at some point between January 1, 2005, and case history review. RESULTS: We recorded 527 treatments: 73.1% pharmacological (32.3% antibiotic, 20.5% immunomodulator, 20.3% biological) and 26.9% surgical. Mean annual global cost was €8,289/patient, 75.3% (€6,242) of which was accounted for by pharmacological treatments (€13.44 antibiotics; €1,136 immunomodulators; €5,093 biological agents), 12.4% (€1,027) by hospitalizations and surgery, 7.7% (€640) by medical visits, 4.2% (€350) by laboratory/diagnostic tests, and 0.4% (€30) by emergency department visits. CONCLUSIONS: Pharmacological therapies, and in particular biological agents, are the main cost driver in complex perianal CD; costs due to surgery and hospitalizations are much lower.

Hospitalizations due to severe hypoglycemia in patients with diabetes mellitus in Spain.

BACKGROUND AND OBJECTIVES: One of the most important therapeutic complications in patients with diabetes mellitus (DM) is hypoglycemia. This study has estimated the number of hospitalizations due to severe hypoglycemia in patients with type DM1 and DM2. PATIENTS AND METHODS: The study hospital population was defined using the National Catalogue of Hospitals (CNH) 2007 (last available data), and has included 260 general hospitals of the National Health System. The number of hospitalizations due to severe hypoglycemia was obtained from the Basic Minimum Data Set (BMDS) for the 183 hospitals. For the remaining 77 hospitals, this number was estimated based on the available information. RESULTS: In 2007, there were 26,701 (0.82%) hospitalizations with hypoglycemia. In DM2 patients, 8,242 (0.25%) episodes were reported as primary diagnosis and 16,649 (0.51%) as secondary. In DM1 patients, 1,157 (0.04%) and 653 (0.02%) episodes were reported as primary and secondary diagnosis, respectively. Overall incidence in DM2 was 1.82 episodes/10,000 inhabitants-year, this ranging between 1.10 episodes/10,000 inhabitants-year in the Islas Canarias to 3.37 in Castilla y León. CONCLUSIONS: Severe hypoglycemia is an important reason for hospitalization of patients with DM in Spain, there being great variability according to the Autonomous Regions.

Mapping CushingQOL scores to EQ-5D utility values using data from the European Registry on Cushing's syndrome (ERCUSYN).

PURPOSE: To construct a model to predict preference-adjusted EuroQol 5D (EQ-5D) health utilities for CS using the disease-specific health-related quality of life measure (CushingQOL). METHODS: Data were obtained from the European Registry on CS (ERCUSYN). ERCUSYN is a web-based, multicenter, observational study that enrolled 508 CS patients from 36 centers in 23 European countries. Patients included in the study completed both the EQ-5D and the disease-specific CushingQOL questionnaire. Socio-demographic and clinical data were also collected. The UK tariff values were used to calculate EQ-5D utility scores. Various predictive models were tested, and the final model was selected based on four criteria: explanatory power (adjusted R-squared), consistency of estimated coefficients (sign and parameter estimation), normality of prediction errors (mean error, mean absolute error, root mean squared error), and parsimony. RESULTS: For the mapping analysis, data were available from a total of 129 patients. Mean (SD) age was 43.1 (13) years, and the sample was predominantly female (84.5 %). Patients had a mean (SD) CushingQOL score of 39.7 (17.1) and a mean (SD) 'tariff' value on the EQ-5D of 0.55 (0.3). The model which best met the criteria for selection included the intercept and 3 CushingQOL's questions and had an R(2) of 0.506 and a root mean square error of 0.216. CONCLUSIONS: It was possible to find a mapping function which successfully predicted the EQ-5D UK utilities from disease-specific CushingQOL scores. The function may be useful in calculating EQ-5D scores when EQ-5D data have not been gathered directly in a study.

Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L).

PURPOSE: This article introduces the new 5-level EQ-5D (EQ-5D-5L) health status measure. METHODS: EQ-5D currently measures health using three levels of severity in five dimensions. A EuroQol Group task force was established to find ways of improving the instrument's sensitivity and reducing ceiling effects by increasing the number of severity levels. The study was performed in the United Kingdom and Spain. Severity labels for 5 levels in each dimension were identified using response scaling. Focus groups were used to investigate the face and content validity of the new versions, including hypothetical health states generated from those versions. RESULTS: Selecting labels at approximately the 25th, 50th, and 75th centiles produced two alternative 5-level versions. Focus group work showed a slight preference for the wording 'slight-moderate-severe' problems, with anchors of 'no problems' and 'unable to do' in the EQ-5D functional dimensions. Similar wording was used in the Pain/Discomfort and Anxiety/Depression dimensions. Hypothetical health states were well understood though participants stressed the need for the internal coherence of health states. CONCLUSIONS: A 5-level version of the EQ-5D has been developed by the EuroQol Group. Further testing is required to determine whether the new version improves sensitivity and reduces ceiling effects.

Development and validation of a questionnaire to assess asthma control in pediatrics.

OBJECTIVE: To develop and validate a questionnaire to assess asthma control in children (CAN). DESIGN: Two versions of the CAN (for carers and children) were developed. Both versions were validated in an observational, prospective, multicenter study performed in 38 hospital outpatient clinics throughout Spain. Four hundred fifteen patients and their carers agreed to participate. Of these, 414 patients under 14 years old with frequent episodic or persistent (moderate to severe) asthma completed the questionnaire on 3 occasions (baseline, week 2, and week 12). For patients aged 2-8 the questionnaire was only completed by the carers, but for patients aged 9-14 the questionnaire was completed by the carers and the children. Clinician ratings of asthma control were used as a gold standard to assess the sensitivity, specificity, PPV and NPV of the new measure. RESULTS: Evaluable responses were obtained from 215 carers for children aged 2-8 years and 199 children aged 9-14 years, and their parents. Using a questionnaire total score cut-off of 8 the patient version had a sensitivity of 76.3% and a specificity of 62.9%. For carer version these values were 73% and 69.7%, respectively. A cut point of 8 was selected to maximize the screening accuracy of the CAN questionnaire. Effect sizes in patients with clinician-rated improvements in asthma control were 0.33 and 0.57 for the carer and child versions, respectively. CONCLUSIONS: The screening accuracy and validity of the CAN questionnaire make it suitable for use in research and clinical practice. The sensitivity and specificity were close to 70%, which is acceptable for the study objective: obtain a tool to measure the level of asthma control.

[The impact of obesity in the management and evolution of diabetes mellitus]. / El impacto de la obesidad en el manejo y evolución de la diabetes mellitus.

OBJECTIVES: To assess both management and evolution of diabetes mellitus type 2 (DM2) in Primary Care centers in Spain and the related factors, especially obesity. METHODOLOGY: Epidemiological, cross-sectional, multicenter, retrospective study. PATIENTS: Patients suffering from DM2, over 20 years of age, were consecutively enrolled from 30 Primary Care centers in 16 autonomous communities. Métodos. Data was collected on age, gender, educational level, DM2 duration, HbA1c, treatment and body measurement index (BMI). RESULTS: A total of 294 patients, 50% male, with a mean age (SD) of 67.5 years (10.2) and BMI 28.9 (4.5) kg/m(2) were included. Of them, 58.16% had HbA1c levels >6.5%, 38% being obese or severely obese. A total of 93.9% were under drug treatment for DM2. Significant differences in the mean value of HbA1c were shown between the over-weight and severely obese groups (Tukey-Kramer test). Differences were observed in the presence of macrovascular complications between patients with normal weight and patients with obesity (p=0.006). Patients with low educational level had 3.39 more probability of being obese or severely obese than patients with secondary school or university studies (p=0.0041; 95% CI 1.47-7.80), and patients with primary school 2.22 more probability (p= 0.038; 95% CI 1.04-4.73). A total of 47.8% reported high compliance. Obese and severely obese patients showed 2.2 more probability of having low or mild compliance than non-obese patients (p=0.002; 95% CI 1.31-3.74). CONCLUSIONS: Results obtained in this population suggest that obesity is related with more macro-vascular complications, worst metabolic control and worst compliance.

Quality of life in acromegalic patients during long-term somatostatin analog treatment with and without pegvisomant.

OBJECTIVE: The objective of the study was to assess whether weekly administration of 40 mg pegvisomant (PEG-V) improves quality of life (QoL) and metabolic parameters in acromegalic patients with normal age-adjusted IGF-I concentrations during long-acting somatostatin analog (SSA) treatment. DESIGN: This was a prospective, investigator-initiated, double blind, placebo-controlled, crossover study. Twenty acromegalic subjects received either PEG-V or placebo for two consecutive treatment periods of 16 wk, separated by a washout period of 4 wk. Efficacy was assessed as change between baseline and end of each treatment period. QoL was assessed by the Acromegaly Quality of Life Questionnaire (AcroQoL) and the Patient-Assessed Acromegaly Symptom Questionnaire (PASQ). RESULTS: The AcroQoL (P = 0.008) and AcroQoL physical (P = 0.002) improved significantly after PEG-V was added. The addition of PEG-V also significantly improved the PASQ (P = 0.038) and the single PASQ questions, perspiration (P = 0.024), soft tissue swelling (P = 0.036), and overall health status (P = 0.035). No significant change in Z-score of IGF-I (P = 0.34) was observed during addition of PEG-V. Transient liver enzyme elevations were observed in five subjects (25%). CONCLUSION: Improvement in quality of life was observed without significant change in IGF-I after the addition of 40 mg pegvisomant weekly to monthly SSA therapy in acromegalic patients who had normalized IGF-I on SSA monotherapy. These data question the current recommendations in how to assess disease activity in acromegaly. Moreover, the findings question the validity of the current approach of medical treatment in which pegvisomant is used only when SSA therapy has failed to normalize IGF-I.

[Validation of the Spanish version of the Benign Prostatic Hyperplasia Impact Index Questionnaire. "Validart Study"]. / Validación de la versión española del Cuestionario Benign Prostatic Hyperplasia Impact Index. "Estudio Validart".

INTRODUCTION: Benign Prostatic Hyperplasia is a chronic disease that affects Health related quality of life (HRQL). In Spain there are no specific questionnaires to assess HRQL in patients suffering from BPH. The objective of this study was to validate the Spanish version of the Benign Prostatic Hyperplasia Impact Index (BII) questionnaire. MATERIAL AND METHODS: Study participants were men over 49 with confirmed BPH diagnosis and evaluated in three visits. Psychometric properties of the questionnaire were analyzed in terms of validity, reliability and sensitivity to change. RESULTS: A total of 1,719 men with mean (SD) age 68.36 were evaluated and classified according to the BPH severity. Both longitudinal and construct validity (r>0.6) of the BII questionnaire were moderate-high. Internal consistency (alpha=0.91), test-retest reliability (CCI=0.8) and sensitivity to change (effect size=0.6) showed good results. The HRQL improved significantly during the monitoring period (p<0.01). DISCUSSION: There were no available specific HRQL questionnaires for Spanish population with BPH until now. The Spanish version of the BII questionnaire fulfils with the psychometric properties that are necessary to evaluate HRQL in patients with BPH; furthermore, it has been confirm the considerable impact of this disease in the quality of life of this patients.

Evaluation of health-related quality of life in patients with Cushing's syndrome with a new questionnaire.

UNLABELLED: Chronic exposure to hypercortisolism has significant impact on patient's health and health-related quality of life (HRQoL), as demonstrated with generic questionnaires. We have developed a disease-generated questionnaire to evaluate HRQoL in patients with Cushing's syndrome (CS; CushingQoL). OBJECTIVE: Validate the CushingQoL questionnaire in patients with CS in clinical practice conditions. DESIGN: Observational, international, cross-sectional study. METHODS: A total of 125 patients were recruited by 14 investigators from Spain, France, Germany, The Netherlands, and Italy over a 2-month period. Clinical and hormonal data were collected and correlated with results of the generic short form 36 (SF-36) questionnaire, a question on self-perceived general health status and the CushingQoL score. RESULTS: A total of 107 patients were pituitary-dependent and 18 adrenal-dependent CS; 104 (83%) were females, mean age 45 years (range 20-73 years); 39 (31%) were currently hypercortisolemic; and 47 (38%) adrenal insufficient. In clinical practice, CushingQoL was feasible (117; 94% of patients fully responded to the questionnaire in a mean time of 4 min), reliable (Crohnbach's alpha=0.87), and valid (factorial analysis demonstrated unidimensionality and Rasch analysis lead to a final version with 12 items). A significant (P<0.001) correlation was observed between CushingQoL score and patients self-perceived general health status and dimensions of SF-36 (Pearson's correlation coefficient > or =0.597). Patients with current hypercortisolism scored worse (lower) than those without (44+/-22 vs 56+/-21, P=0.004). Linear regression analysis identified female gender and hypercortisolism as significant predictors for worse QoL. CONCLUSION: CushingQoL is useful to evaluate HRQoL in patients with CS and correlates with clinical parameters.

Validation of the Spanish version of the Asthma Control Test (ACT).

OBJECTIVE: Validation of the Spanish version of the Asthma Control Test (ACT). METHODS: A total of 607 asthmatic patients were assessed. The psychometric properties of ACT were evaluated. The ACT capacity to predict the physician's assessment of asthma control was assessed using the area under the receiving operating characteristics (ROC) curve (AUC), sensitivity, specificity, and positive-negative predictive values. RESULTS: ACT's Cronbach alpha was 0.84. The intraclass correlation coefficient was 0.85. The AUC was 0.86, with a sensitivity of 71% and a specificity of 85% for a score of < or =19. CONCLUSIONS: The Spanish version of ACT is shown to be a reliable and valid tool for evaluating and discriminating asthma control.

Cost-effectiveness analysis of enfuvirtide (ENF) added to an optimized therapy compared with an optimized therapy in patients with HIV/AIDS.

BACKGROUND: Fuzeon (enfuvirtide) (ENF) is the first drug among the HIV fusion inhibitors that has shown high efficacy in HIV-1/AIDS patients resistant to conventional antiretroviral agents. PURPOSE: To analyze the cost-effectiveness of ENF plus optimized therapy (OT) in HIV patients. METHOD: A Markov model was used to calculate the cost-effectiveness of ENF in terms of incremental cost per life-year gained. The model has a 10-year horizon, with monthly cycles, and the perspective is the Spanish National Health System. Efficacy rates and transition probabilities were obtained from clinical and epidemiological trials. Resource use data were retrieved from published literature and a panel of clinicians. Unit costs refer to the year 2003. MAIN OUTCOME MEASURE: Incremental cost-effectiveness ratio. RESULTS: Adding ENF to OT increased patient life expectancy by 1.6 years (6.2 years with OT compared with 7.8 years with ENF + OT). Total costs were 160,728 euro for OT and 200,859 euro with ENF + OT, mainly due to increasing life expectancy raising resource use and costs. Incremental cost per life-year gained with ENF was 25,082 euro. CONCLUSION: ENF plus OT increased life expectancy for HIV-1-treated patients and is an efficient treatment option.

Treatment of acromegaly improves quality of life, measured by AcroQol.

BACKGROUND: AcroQol is a disease-generated questionnaire, developed to assess quality of life (QOL) in patients with acromegaly. We have previously demonstrated severely impaired QOL in patients with acromegaly and the value of AcroQol in measuring QOL in a cross-sectional study compared with the non-disease-specific generic tools 'Psychological general wellbeing schedule' (PGWBS) and EuroQol (EQ-5D), and the disease-specific signs and symptoms score (SSS). AIM, SUBJECTS AND METHODS: We re-evaluated these tools in a longitudinal study of 56 of the previously reported patients (33 male, mean age 55 +/- 15 years), in order to determine change in QOL over time and the effect of different treatment modalities. Data were analysed using Spearman's correlation tests. RESULTS: Baseline median IGF-I was 354 ng/ml (range 48-899) and at re-evaluation 217 ng/ml (60-594) (P < 0.001) [median time interval 608 days (113-1136)]. Analysis of change in IGF-I levels and AcroQol scores demonstrated a significant negative correlation (i.e. a reduction in IGF-I being associated with improved overall QOL (r = -0.36, P = 0.006). Significant negative correlations were also seen in the physical (r = -0.33, P = 0.01), psychological (r = -0.37, P = 0.005) and appearance (r = -0.42, P = 0.001) AcroQol subdomains. No correlations were seen between change in IGF-I and change in overall PGWBS score or subdomains, SSS or EQ-5D. CONCLUSIONS: In summary, of the tools studied we have demonstrated AcroQol to be uniquely capable of detecting changes in QOL associated with treatment-induced improvement in the main biochemical marker of disease activity in patients with acromegaly. Further studies are required to evaluate the long-term biological significance of the changes seen in AcroQol.

Treatment cost of ulcerative colitis is apheresis with Adacolumn cost-effective?

BACKGROUND: Scarce data are available in Europe on the cost of treatment for ulcerative colitis (UC). AIM: To assess the cost of illness of moderate-to-severe UC in two scenarios: traditional treatment versus alternative treatment incorporating granulocyte, monocyte adsorption - apheresis (GMA-Apheresis; Adacolumn). To determine the relative cost-effectiveness of both options in steroid-dependent patients. METHODS: One-year cost-of-illness and cost-effectiveness analysis from the third-payer perspective using a decision tree model was carried out. Probabilities of each event were derived from the literature and an expert panel. Direct medical costs were obtained from official sources (euro2004). Effectiveness was measured by the proportion of patients achieving clinical remission. RESULTS: The average annual cost per patient treated with traditional treatment was estimated to be euro6740; with GMA-Apheresis, the cost was estimated to be euro6959. In steroid-dependent patients, the average annual cost was euro6059 and euro11,436, respectively. The proportion of patients achieving clinical remission with GMA-Apheresis was 22.5% higher. As second- and third-line therapy, a new course of corticosteroids and surgery was avoided in 18.5 and 4% of patients, respectively. CONCLUSIONS: Incorporating GMA-Apheresis (Adacolumn) in the therapeutic management of moderate-to-severe UC patients is cost-effective and implies savings related to the reduction of adverse effects derived from corticosteroid use and to the decreased number of surgical interventions.