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.

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.

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.

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.

[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.

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.

Change over time of bowel habit in irritable bowel syndrome: a prospective, observational, 1-year follow-up study (RITMO study).

BACKGROUND: Evolution of bowel habit in irritable bowel syndrome (IBS) is not well known. AIM: To evaluate the change over time of bowel habit in IBS patients followed-up during 1 year. METHODS: Five hundred and seventeen patients with IBS were prospectively included in an observational study with five evaluations over a 1-year period. Symptoms were recorded daily in diary cards during four 4-week periods along the study. Bristol Stool Scale (BSS) was used to define bowel habit. RESULTS: Four-hundred patients completed the study. Rome II showed low-moderate agreement (42%) with BSS to define bowel habit. Frequency of constipation and diarrhoea showed little changes throughout the study. Over 50% of the patients had the same bowel habit when each diary was compared with the next one. A third of patients maintained the same habit throughout the study. Most changes occurred from/to mixed or unsubtyped IBS. Only 14% of cases changed from constipation to diarrhoea or vice versa. This change was associated to female gender (OR: 2.65). CONCLUSIONS: The frequency of constipation and diarrhoea remains relatively stable over time. Changes in IBS subtypes are common, but changes between constipation and diarrhoea are rare. Alternating IBS is more frequent in women.

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.

Asthma control in Spain. Do season and treatment pattern matter? The ESCASE study.

The aim of this study was to assess the degree of asthma control according to GINA criteria during two different seasons in Spain. An multicenter, longitudinal, epidemiological study with the participation of a sample of physicians in Spain was conducted. Consecutive asthma patients, 18 years of age and older, seeking primary and specialist care were included in the study. Patients were seen during the winter and spring 2004 and were asked about asthma control according to GINA control criteria (daytime and nighttime symptoms, asthma exacerbations, limitations of physical activity, and visits to the emergency department) during the 4 weeks prior to the visit. Control was defined according to daytime and nighttime symptoms. A total of 614 patients participated in the study. The proportion of patients reporting daytime symptoms "every day" or "most days" during the winter versus spring was 40.1% vs. 23% (P<0.01); 26.9% vs. 14.1% presented symptoms at night (P<0.01); 11.5% vs. 8.3% had severe exacerbations; 33.5% vs. 35.7% presented symptoms accompanying exercise, and 9.4% vs. 4.3% (P<0.01) had required emergency visits. The number of patients with inadequate control was slightly higher in winter than in spring (74.4% vs. 71%) (P<0.01). The most commonly prescribed treatment was ICS plus LABAs for both periods. Asthma is poorly controlled in Spain and strategies are needed to improve management of this illness.

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.

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.

Predictive factors of irritable bowel syndrome improvement: 1-year prospective evaluation in 400 patients.

BACKGROUND: The natural history of the irritable bowel syndrome is poorly understood. AIM: To assess the clinical course of the irritable bowel syndrome and the factors that might predict it. METHODS: An observational prospective study, involving 400 irritable bowel syndrome patients meeting Rome II criteria. Symptoms were recorded in a diary over four non-consecutive months (1, 4, 7 and 10). Demographic data, associated disorders, psychological status and health-related quality of life were obtained. RESULTS: At 1-year follow-up, half of the patients and half of their physicians considered irritable bowel syndrome to have improved, but improvement was minor. Diary data showed that, according to the type of symptom, improvement was small and quite different: diarrhoea in 19% of patients, abdominal pain frequency in 26%, constipation in 33% and abdominal pain intensity in 60%. Factors related to improvement at one year were: severe symptoms and poor health-related quality of life at first visit, irritable bowel syndrome-constipation, good improvement at 3 months, anxiety/depression, stress, symptoms related to meals and absence of comorbidity. By multivariate logistic regression, predictors were: severe basal symptoms and good improvement at 3 months (OR:CI 95%, 1.32:1.09-1.59 and 4.44:2.81-7.05). CONCLUSIONS: At 1-year follow-up, half the patients and their physicians considered the irritable bowel syndrome to have had some improvement but, symptom diaries demonstrated that improvement was small and heterogeneous. Severe basal symptoms and improvement at 3 months were related to better prognosis.

[Cost-minimisation analysis of the pharmacological treatment of epilepsy in Spain]. / Análisis de minimización de costes del tratamiento farmacológico antiepiléptico en España.

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.

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.

Quality of life (QOL) in patients with acromegaly is severely impaired: use of a novel measure of QOL: acromegaly quality of life questionnaire.

Acromegaly Quality of Life Questionnaire (AcroQoL) is a new disease-generated quality of life (QOL) questionnaire comprising 22 questions covering physical and psychological aspects of acromegaly and subdivided into "appearance" and "personal relations" categories. We have performed a cross-sectional study of QOL in 80 patients [43 male (mean age, 54.2 yr; range, 20-84); median GH, 0.93ng/ml (range, <0.3 to 23.7); IGF-I, 333.1 ng/ml (range, 47.7-899)] with acromegaly. In addition to AcroQoL, patients completed three generic QOL questionnaires: Psychological General Well-Being Schedule (PGWBS), EuroQol, and a signs and symptoms score (SSS). All three generic questionnaires confirmed impairment in QOL [mean scores: PGWBS, 69.6; EuroQol, visual analog scale, 66.4 (range, 20-100) and utility index, 0.7 (range, -0.07 to 0.92); and SSS, 12 (range, 0-27)]. There was no correlation between biochemical control and any measure of QOL. AcroQoL (57.3%; range, 18.2-93.2) correlated with PGWBS (r = 0.73; P < 0.0001); and in patients with active disease, AcroQoL-physical dimension correlated with SSS (r = -0.67; P < 0.0003). In all questionnaires, prior radiotherapy was associated with impaired QOL. In conclusion, these data underline the marked impact that acromegaly has on patients' QOL and provide the first evidence validating AcroQoL against well-authenticated measures of QOL. This indicates the potential of AcroQoL as a patient-friendly measure of disease activity.