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.

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.

[Development and psychometric validation of a new screening questionnaire for erectile dysfunction (SQUED questionnaire)]. / Desarrollo y validación psicométrica de un nuevo cuestionario de screening para la disfunción eréctil (cuestionario SQUED).

BACKGROUND: It is necessary to have simple tools to screen erectile dysfunction (ED) in an easy, reliable and valid manner. The objective of this study was to develop and validate a short diagnostic questionnaire for erectile dysfunction [SQUED), easy to use in the primary care setting. SUBJECTS AND METHOD: The development of SQUED included: concepts identification, item generation and evaluation of contents and face validity through interviews with subjects to assess comprehension and idiomatic adequacy. The psychometric validation was conducted in an epidemiologic, observational, comparative and multicenter study. Participants should complete the questionnaire in primary care setting and send to the specialist to confirm the diagnosis by an in depth interview and the application of IIEF questionnaire. Internal consistency, test-retest reliability and sensitivity and specificity of SQUED was evaluated. RESULTS: Out of 405 subjects enrolled, 316 (208 ED and 108 non-ED) were evaluable. The SQUED questionnaire showed a high internal consistency (Cronbach's alpha = 0.92) and a good test-retest reliability (Kappa index = 0.77). Furthermore, the questionnaire showed a good diagnostic capacity with high values of sensitivity and specificity, 0.87 and 0.78, respectively, in relation to the diagnosis made by urologists. The cutting point was established at a score of 12. DISCUSSION: The SQUED questionnaire is a simple, easy to use and reliable instrument. It can become a useful tool, and the shortest validated, for primary care physicians to easily screen for ED patients. Its simplicity should facilitate an easy cultural adaptation and validation into other languages.

Effect of mode of administration on I-PSS scores in a large BPH patient population.

OBJECTIVES: The International Prostate Symptoms Score (I-PSS) was designed to be self-administered to patients with benign prostatic hyperplasia. This study tested for a possible mode of administration effect on the I-PSS and assessed the reliability of the I-PSS over time when modes of administration varied. METHODS: Benign prostatic hyperplasia patients over 50 years of age were recruited at 52 Spanish centres. The I-PSS was administered on two occasions 1 month apart. Patients were sequentially classified into groups A-D according to the mode of administration (S = self-administered, I = interview administered) at the two visits (A = S-S, B = S-I, C = I-S, and D = I-I). The intraclass correlation coefficient was used to assess test-retest reliability, and multiple regression analysis was used to test the effects of the mode of administration and the visit number on I-PSS scores. RESULTS: 926 patients (mean age 66 years) were evaluated. The mean I-PSSs symptoms score at visit 1 in groups A-D were, respectively, 13.19, 13.57, 12.06, and 12.29. Multiple regression analysis between-group scores were 0.93 points higher when the I-PSS was self-administered and 1.98 points lower at the second visit. The intraclass correlation coefficients were: group A = 0.77, group B = 0.70, group C = 0.67, and group D = 0.76. CONCLUSIONS: Interview administration of the I-PSS results in slightly lower scores. The reliability is higher when the same mode of administration is used at two recurrent visits.

[Socioclinical and diagnostic characteristics of prostatism in Spain at the end of the 20th century]. / Características sociosanitarias y diagnósticas del paciente prostático en España a finales del siglo XX.

RATIONALE: To study sociodemographic characteristics and current diagnostic and therapeutic behaviour with Benign Prostate Hyperplasia (BPH) patients in Spain at the end of the 20th century. METHODS: Sociodemographic, clinical, therapeutic and quality of life (QoL) data from study ESECI-98, conducted in Spain (1998-1999) in patients with BPH. RESULTS: Nine hundred and forty nine patients were evaluable, with a mean (+/- SD) age of 65.6 (+/- 7.8) years, with concomitant diseases (40%), pain/discomfort (34%) and anxiety/depression (23%); QoL score (mean +/- SD) was 72.1 +/- 16.1 on a total possible score of 100. BPH diagnosis was based on symptoms (93%), digital rectal examination (93%) and abdomino-pelvic ultrasonography (76%). PSA was mentioned for the diagnosis of BPH in 54% of the patients and 77% were receiving pharmacological treatment (61% alpha-blockers) during less than 6 months (38%) or more than a year (35%). CONCLUSIONS: In this study the diagnosis of BPH was mainly based on symptoms, digital rectal examination and abdomino-pelvic ultrasonography. It is worth mentioning that PSA for the diagnosis of BPH, was used in a half of the total number of patients. Pharmacological therapy was used in 3 out of every 4 patients. Compared to a previous national study, there is a change on diagnosis and therapy of BPH.

Influence of sociodemographic and health status variables on the American Urological Association symptom scores in patients with lower urinary tract symptoms.

OBJECTIVES: To evaluate the relationship between sociodemographic and health status variables and the American Urological Association Symptom Score (AUA-7) because low associations between clinical measures of lower urinary tract symptoms and scores on the AUA-7 suggest that symptoms may be influenced by other variables. METHODS: Sociodemographic, clinical, and health status variables were recorded for 666 patients with benign prostatic hyperplasia (BPH). BPH symptoms were measured with the AUA-7. Bivariate and multivariate analyses were used to determine correlations between sociodemographic and health status variables and AUA-7 scores. RESULTS: BPH-related variables (clinical rating of severity, number of BPH treatments, and being scheduled for surgery) were included in the final regression model, which explained 25% of the overall variability in scores. An additional 7% of the total variability was explained by other non-BPH-related variables (educational level, presence of depression/anxiety, and pain/discomfort). CONCLUSIONS: The AUA-7 is a robust questionnaire that is little influenced by sociodemographic variables and general health status. The educational level, mood, and presence of pain/discomfort of patients should be taken into account when interpreting scores, as a combination of these characteristics could mean a difference of up to 6 points on the AUA-7.

A placebo-controlled study of interaction between nabumetone and acenocoumarol.

AIMS: The use of nonsteroidal anti-inflammatory drugs (NSAIDs) in patients treated with oral anticoagulants is generally discouraged due to the risk of interactions that could increase the risk of bleeding complications. Available data suggest the NSAID, nabumetone, does not produce such an interaction. We investigated whether nabumetone would interact with acenocoumarol, an oral anticoagulant widely used in some European countries. METHODS: A double-blind, randomized, placebo-controlled study was conducted evaluating nabumetone (1-2 g daily for up to 4 weeks) in osteoarthritis patients with thromboembolic risk previously stabilized on acenocoumarol. The primary efficacy end point was the proportion of patients whose International Normalized Ratio (INR) remained within established margins and whose acenocoumarol dose was not changed. Fifty-six patients were randomized to receive nabumetone (n=27) or placebo (n=29). RESULTS: Eighteen patients in each group (67% for nabumetone and 62% for placebo) completed the study without showing INR or acenocoumarol dose changes, and were considered as study successes. Nine patients (33%) with nabumetone and 11 (38%) with placebo were considered study failures in the intention-to-treat analysis (one patient on nabumetone and four on placebo did not complete the study due to reasons not related to INR and acenocoumarol dose changes). No significant differences were found between groups with regard to study successes. There were two minor bleeding complications, one in each group. Six patients per group presented with eight adverse experiences in each group. CONCLUSIONS: Treatment with nabumetone did not alter INR levels compared with placebo in patients stabilized on oral acenocoumarol who require NSAID therapy. These results suggest that nabumetone does not produce a clinically relevant interaction with acenocoumarol. In orally anticoagulated patients without other associated risk factors, treatment with nabumetone for up to 4 weeks does not require increased monitoring of INR levels.

Validation of a harmonized Spanish version of the IPSS: evidence of equivalence with the original American scale. International Prostate Symptom Score.

OBJECTIVES: To validate the use in Spain of a linguistically harmonized Spanish version of the International Prostate Symptom Score (IPSS Sp), and to compare it with the original American scale (IPSS Am). METHODS: Validity and reliability were studied in 59 patients with benign prostatic hyperplasia (BPH) (age >50 years) and 68 control subjects without BPH (age 18 to 49 years). Construct validity was assessed by correlating IPSS Sp scores with the EuroQol-5D (EQ-5D), the Psychological General Well-Being Index (PGWBI), and item 8 (quality of life) of the IPSS. Discriminatory power was assessed by calculating the area under the receiver operating characteristic (ROC) curve. Reliability was evaluated using the test-retest method, and internal consistency was assessed using Cronbach's alpha. Sensitivity to change was expressed as the effect size in preintervention versus postintervention scores in 26 additional patients with BPH (age >50 years) who underwent transurethral resection of the prostate. RESULTS: Correlations of the IPSS Sp were -0.07 to 0.36 with EQ dimensions; -0.29 with the EQ visual analogue scale score; 0.14 to 0.41 with PGWBI dimensions; and 0.72 with item 8 of the IPSS. ROC area was 0.95 +/- 0.02 (standard error). Using a cutoff point of 7, sensitivity was 83% and specificity was 98%. Test-retest reliability was 0.92 and Cronbach's alpha was 0.79. Mean preoperative and postoperative IPSS Sp scores were 25.56 and 8.48, respectively (P < 0.001 ). Overall effect size was 2.52. These results are similar to those of the original American scale. CONCLUSIONS: This Spanish translation of the IPSS is valid, reliable, and sensitive to clinical change and has demonstrated equivalent psychometric properties to the original American instrument. Scores obtained with the two instruments can therefore be reliably compared and aggregated when statistically appropriate.

Ten-language translation and harmonization of the International Prostate Symptom Score: developing a methodology for multinational clinical trials.

OBJECTIVE: Production of cross-culturally adapted and harmonized translations of the International Prostate Symptom Score (I-PSS) into 10 languages (Canadian French, Danish, Dutch, Flemish, French, German, Italian, Norwegian, Spanish, Swedish) by means of an appropriate methodology. METHODS: A method based on state-of-the-art guidelines about translation of questionnaires was developed which consisted of forward-translation, rating of clarity, common language and cultural adequacy, group discussion and consensus, testing for comprehension in lay subjects, back-translation and rating for conceptual equivalence. RESULTS: The study lasted 3 months. Items 1-7 scored high for clarity, common language and cultural adequacy (mean range 5.3-9.8) as also did item 8 (5.1-9.7). Only 10% of items were rated less than 5.0. Comprehension tests in lay subjects produced comments in 10% of items, most frequently in items 2, 7, and 8, and response categories for items 1-6. Comparisons between the back-translations and the source version showed that 84% of all items, 88% of response categories for items 1-6, 100% of response categories for item 7, and 75% of response categories from item 8 were conceptually equivalent. CONCLUSION: The present set of 10 translations plus the original I-PSS questionnaire can be used in multi-country studies in which benign prostatic hyperplasia symptoms are to be assessed using the I-PSS and the data collected from different countries can be legitimately aggregated.