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Disease Questionnaire (disease + questionnaire)
Kinds of Disease Questionnaire Selected AbstractsDoes primary sclerosing cholangitis impact quality of life in patients with inflammatory bowel disease?INFLAMMATORY BOWEL DISEASES, Issue 3 2010Ashwin N. Ananthakrishnan MD Abstract Background: Impairment of health-related quality of life (HRQoL) is an important concern in inflammatory bowel disease (IBD; ulcerative colitis [UC], Crohn's disease [CD]). Between 2%,10% of patients with IBD have primary sclerosing cholangitis (PSC). There has been limited examination of the disease-specific HRQoL in this population compared to non-PSC IBD controls. Methods: This was a retrospective, case,control study performed at a tertiary referral center. Cases comprised 26 patients with a known diagnosis of PSC and IBD (17 UC, 9 CD). Three random controls were selected for each case after matching for IBD type, gender, age, and duration of disease. Disease-specific HRQoL was measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Disease activity for CD was measured using the Harvey,Bradshaw index (HB) and using the UC activity index for UC. Independent predictors of HRQoL were identified. Results: There was no significant difference in the age, gender distribution, or disease duration between PSC-IBD and controls. There was no difference in use of immunomodulators or biologics between the 2 groups. Mean SIBDQ score was comparable between PSC-IBD patients (54.5) and controls (54.1), both for UC and CD. Likewise, the disease activity scores were also similar (2.8 versus 3.1, P = 0.35). On multivariate analysis, higher disease activity score (,1.33, 95% confidence interval [CI] 95% CI ,1.85 to ,0.82) and shorter disease duration were predictive of lower HRQoL. Coexisting PSC did not influence IBD-related HRQoL. There was a higher proportion of permanent work disability in PSC-IBD (7.7%) compared to controls (0%). Conclusions: PSC does not seem to influence disease-specific HRQoL in our patients with IBD but is associated with a higher rate of work disability. (Inflamm Bowel Dis 2010) [source] Randomized, placebo-controlled trial of low molecular weight heparin in active ulcerative colitisINFLAMMATORY BOWEL DISEASES, Issue 6 2007M.A. de Bièvre MD Abstract Background: In several open and 1 controlled trial, unfractionated heparin was effective in the treatment of active ulcerative colitis (UC). Low molecular weight heparin (LMWH) had a similar effect in several open studies. Methods: We studied the efficacy, safety, and tolerability of LMWH in mild to moderately active UC in a randomized, double-blind, placebo-controlled trial. In all, 29 patients with a mild or moderate recurrence of UC during salicylate treatment were randomized to receive either reviparin 3,436 IU (n = 15) subcutaneously twice daily or placebo (n = 14). The study period was 8 weeks. Treatment was discontinued if there was no improvement at 4 weeks or at any disease progression. Primary outcome measure was clinical improvement at 8 weeks measured by the Colitis Activity Index (CAI) and the Clinical Symptoms Grading (CSG, based on the CAI). Endoscopic and histologic grading and quality of life as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) were secondary outcome measures. Patients were closely monitored for adverse events. Results: Twenty of 29 patients finished the 8-week treatment period (reviparin versus placebo: 11 versus 9; P = 0.70). There was no difference in CSG, CAI, endoscopic and histologic grading, or IBDQ. Treatment was well tolerated and no serious adverse events occurred. Conclusion: In this study, treatment with LMWH showed no significant clinical advantage compared to placebo in mild to moderately active UC. (Inflamm Bowel Dis 2007) [source] Relationship between sick leave, unemployment, disability, and health-related quality of life in patients with inflammatory bowel diseaseINFLAMMATORY BOWEL DISEASES, Issue 5 2006Tomm Bernklev BSc Background: The goal of this study was to determine the rate of work disability, unemployment, and sick leave in an unselected inflammatory bowel disease (IBD) cohort and to measure the effect of working status and disability on the patient's health-related quality of life (HRQOL). Materials and Methods: All eligible patients were clinically examined and interviewed at the 5-year follow-up visit. In addition, they completed the 2 HRQOL questionnaires, the Short Form-36 Health Survey (SF-36) and the Inflammatory Bowel Disease Questionnaire validated for use in Norway (N-IBDQ). Data regarding sick leave, unemployment, and disability pension (DP) also were collected. Results: All together, 495 patients were or had been in the workforce during the 5-year follow-up period since diagnosis. Forty-two patients (8.5%) were on DP compared with 8.8% in the background population. Women with Crohn's disease (CD) had the highest probability of receiving DP (24.6%). A total of 58 patients (11.7%) reported they were unemployed at 5 years. This was equally distributed between men and women but was more frequent in patients with ulcerative colitis. Sick leave for all causes was reported in 47% with ulcerative colitis and 53% with CD, whereas IBD-related sick leave was reported in 18% and 23%, respectively. A majority (75%) had been sick <4 weeks, and a relatively small number of patients (25%) contributed to a large number of the total sick leave days. Both unemployment and DP reduced HRQOL scores, but the most pronounced effect on HRQOL was found in patients reporting IBD-related sick leave, measured with SF-36 and N-IBDQ. The observed differences also were highly clinically significant. Multiple regression analysis confirmed that IBD-related sick leave was the independent variable with the strongest association to the observed reduction in HRQOL scores. Conclusions: Unemployment or sick leave is more common in IBD patients than in the Norwegian background population. The number of patients receiving DP is significantly increased in women with CD but not in the other patient groups. Unemployment, sick leave, and DP are related to the patient's HRQOL in a negative way, but this effect is most pronounced in patients reporting IBD-related sick leave. [source] Impairment of health-related quality of life in patients with inflammatory bowel disease: A Spanish multicenter studyINFLAMMATORY BOWEL DISEASES, Issue 5 2005Dr. F Casellas PhD Abstract Background: Inflammatory bowel disease impairs patients' perception of health and has a negative impact on health-related quality of life (HRQOL). Most studies include patients from a single hospital. This may bias limit results through the use of small patient samples and/or samples within a restricted disease spectrum. Methods: HRQOL was measured in patients with ulcerative colitis (UC) and Crohn's disease (CD) from 9 hospitals located in different geographical areas in Spain using 2 questionnaires: the Spanish version of the Inflammatory Bowel Disease Questionnaire (IBDQ) and the EuroQol. Results are expressed as medians. Results: The study included 1156 patients (528 patients with UC and 628 with CD; median age, 35 yr; slight predominance of women, 617 versus 539). HRQOL worsened in parallel with disease severity to a similar extent in both UC (IBDQ scores of 6.1, 4.7, and 4.0 for the 3 disease severity groups, respectively) and CD (IBDQ scores of 6.1, 5.0, and 4.1, respectively). A similar inverse relation between clinical activity and quality of life was observed when EuroQol preference values were used. All 5 dimensions of the IBDQ showed significantly lower scores in patients with active UC and CD than in patients in remission. The pattern of scores by IBDQ dimensions differed between patients in relapse (who scored worse on the digestive symptoms dimension) and patients in remission. Variables related with disease activity, time of evolution since diagnosis and female sex, were significantly associated with having a worse perception of HRQOL. The type of disease or geographical area of residence did not influence results on the IBDQ. Conclusions: UC and CD impair patients' HRQOL, and the degree of impairment depends on disease activity but is independent of the type of disease and place of residence. [source] Shortened questionnaire on quality of life for inflammatory bowel diseaseINFLAMMATORY BOWEL DISEASES, Issue 4 2004M. J. Alcalá MD Abstract Questionnaires for measuring quality of life in patients with inflammatory bowel disease usually include a large number of items and are time-consuming for both administration and interpretation. Our aim was to elaborate and validate a short quality-of-life questionnaire with the most representative items from the Spanish version of the 36-item Inflammatory Bowel Disease Questionnaire (IBDQ-36) using the Rasch analysis. The responses to 311 IBDQ-36 questionnaires from 167 patients with ulcerative colitis (UC) and 144 with Crohn's disease (CD) were analyzed. IBDQ-36 was shortened with successive Rasch analyses until all the remaining items showed acceptable separation and goodness-of-fit properties. Validation of the short questionnaire was studied in a new group of 125 patients by determining its validity and reliability. A 9-item short questionnaire was obtained (IBDQ-9). Its correlation with IBDQ-36 was excellent (r = 0.91). Correlation between IBDQ-9 and clinical indices of activity was statistically significant in UC (r = 0.70) and CD (r = 0.70). IBDQ-9 score discriminates adequately between patients in clinical remission or relapse (P < 0.01). Sensitivity to change was determined in 14 patients who improved clinically, showing significant IBDQ-9 changes between both determinations (P < 0.01), with an effect size of ,2.67 in UC and ,5.29 in CD. IBDQ-9 was also homogeneous, with a Cronbach's , of 0.95 in UC and 0.91 in CD. In 35-clinically stable patients, test-retest reliability was good, with a statistically-significant correlation between both questionnaires (r = 0.76 in UC and 0.86 in CD, P < 0.01) and an intraclass correlation coefficient of 0.82 in UC and 0.84 in CD. In conclusion, a short and valid questionnaire to measure quality of life in patients with inflammatory bowel disease was obtained using a new measurement model. Its use should facilitate comprehension of the impact of inflammatory bowel disease. [source] Infliximab improves quality of life in patients with Crohn's diseaseINFLAMMATORY BOWEL DISEASES, Issue 4 2002Dr. Gary R. Lichtenstein Abstract Objective The aim of this study was to assess the effect of infliximab on quality of life in patients with active Crohn's disease (CD) inadequately responsive to concomitant therapies. Methods We examined responses to the Inflammatory Bowel Disease Questionnaire (IBDQ) from patients enrolled in a previously reported, randomized, placebo-controlled study. Patients with active CD received a single intravenous infusion of either placebo or infliximab 5, 10, or 20 mg/kg. Most patients received stable doses of mesalamine, corticosteroids, azathioprine, or 6-mercaptopurine throughout the study. Changes from baseline in overall IBDQ score and individual dimensions at 4 weeks postinfusion were compared. Results Patients treated with infliximab had a significantly larger improvement in overall IBDQ score than those treated with placebo at 4 weeks (p < 0.001). Infliximab-treated patients also had larger improvements in all IBDQ dimensions: bowel (p = 0.007), social (p = 0.002), emotional (p < 0.001), and systemic (p < 0.001). A significantly larger proportion of infliximab-treated patients reported having normal or near-normal frequency of bowel movements in the past week (p < 0.001), full or a lot of energy (p = 0.019), and no or hardly any difficulty doing leisure or sports activities (p = 0.011), and being extremely or very satisfied with their personal life (p = 0.046). They also significantly differed in responses regarding fatigue, frustration, ability to work, general well-being, depression, anxiety, and anger resulting from bowel problems. Conclusions These results indicate that infliximab significantly improved quality of life in patients with active CD, increasing their ability to work and participate in leisure activities, and decreasing feelings of fatigue, depression, and anger. [source] Assessing health-related quality of life in patients with inflammatory bowel disease in Zhejiang, ChinaJOURNAL OF CLINICAL NURSING, Issue 1-2 2010Yunxian Zhou Aims., The aim of this study was to assess health-related quality of life in patients with inflammatory bowel disease in Zhejiang, Mainland China. Background., The incidence of inflammatory bowel disease in China is believed to be low but has been increasing in the past decade. The quality of life of Chinese patients with inflammatory bowel disease is unknown. Design., A cross-sectional study. Methods., The study was conducted in 92 patients with inflammatory bowel disease in Zhejiang, China, 52 with ulcerative colitis and 40 with Crohn's disease. Health-related quality of life was measured by the Chinese version of the Inflammatory Bowel Disease Questionnaire and Short Form-36, respectively. Disease activity was assessed by the Walmsley and Harvey,Bradshaw simple indices for ulcerative colitis and Crohn's disease, respectively. Demographic and clinical variables were also recorded. Short Form-36 data from the study sample were compared with a reference population of 1688 Chinese people residing in Hangzhou, Zhejiang, China. Results., No significant health-related quality of life differences were found between patients with ulcerative colitis and Crohn's disease (p > 0·05). Pooled data showed that inflammatory bowel disease patients with active disease had significantly lower scores for all eight dimensions of Short Form-36 compared to those in remission (p < 0·01); those with active disease scored significantly lower than population norms in all dimensions of Short Form-36 except mental health (p < 0·05); whereas those in remission scored significantly lower than population norms in role physical (p < 0·01) and general health dimensions (p < 0·05). The regression analyses identified only disease activity index and employment status to explain variations in health-related quality of life (p < 0·01). Conclusions., Inflammatory bowel disease similarly impairs health-related quality of life in patients with both ulcerative colitis and Crohn's disease. Relevance to clinical practice., The results suggest that any interventions that produce a stable clinical remission, whether medical or surgical, allowing patients to return to their usual work position can decrease the disease impact on their daily lives. [source] Psychometric properties of the MacNew heart disease health-related quality of life instrument in patients with heart failureJOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 4 2008Stefan Höfer Abstract Rationale, aims and objectives, Heart failure (HF) is a severe chronic disease and impairs health-related quality of life (HRQL). While validated specific HRQL instruments are required for evaluation of treatment and rehabilitation in patients with HF, a single validated measure to document changes in HRQL for patients with different heart disease diagnoses would be invaluable. The purpose of this analysis was the psychometric analysis of the German MacNew Heart Disease Questionnaire (MacNew) in HF patients, which has previously been shown to be reliable and valid in patients with myocardial infarction, angina pectoris and arrhythmia. Methods, We recruited 89 patients (61.7 ± 11.5 years; 84.3% male) in two Austrian and one Swiss cardiology department with documented HF (effect sizes 28.9 ± 10.1%). The self-administered MacNew, the Short Form-36 (SF-36) and the Hospital Anxiety and Depression Scale were completed. Internal consistency reliability (Cronbach's ,), discriminative and evaluative validity were assessed. Results, Cronbach's , exceeded 0.80. Each MacNew scale differentiated between patients with and without anxiety (3.9 ± 1.0 vs. 5.3 ± 0.8, all P < 0.001), with and without depression (4.2 ± 1.2 vs. 5.2 ± 0.9 all P < 0.03) and by the SF-36 health transition item (deteriorate = 4.39, no change = 4.95, improve = 5.45, all P < 0.02). Evaluative validity was demonstrated with effect sizes >0.70 for a subsample attending a 12-week outpatient rehabilitation programme. Conclusions, The German language version of the MacNew demonstrates consistently acceptable psychometric properties of reliability, validity and responsiveness in patients with documented HF. Together with previous documentation of reliability, validity and responsive, these findings strengthen the argument for the MacNew as a potential ,core' HRQL measure, at least in the German language. [source] Association of body mass index with heartburn, regurgitation and esophagitis: Results of the Progression of Gastroesophageal Reflux Disease studyJOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 11 2007Marc Nocon Abstract Background:, Overweight and obesity are believed to be risk factors for gastroesophageal reflux disease (GERD). The aim of the present study was to analyze the impact of body mass index (BMI) on the severity and frequency of reflux symptoms and esophagitis in a large cohort of reflux patients. Methods:, As part of the Progression of Gastroesophageal Reflux Disease (ProGERD) study, 6215 patients with clinically assessed GERD were included in the present investigation (53% male, 52 ± 14 years; 47% female, 56 ± 14 years). Heartburn and regurgitation symptoms were assessed using the validated Reflux Disease Questionnaire. Endoscopies were performed and patients were subsequently classified as having non-erosive or erosive disease. To examine the association between BMI, GERD symptoms, and esophagitis, odds ratios (OR) and 95% confidence intervals (95%CI) were calculated using logistic regression models. Results:, In patients with GERD, higher BMI was associated with more frequent and more severe heartburn and regurgitation, as well as with esophagitis. The effects were more pronounced for regurgitation than for heartburn. The strongest association was between obesity and severity of regurgitation symptoms (women: OR 2.11, 95%CI 1.60,2.77; men: OR 2.15, 95%CI 1.59,2.90). Obese women, but not men, had an increased risk of severe esophagitis compared to women with normal weight (OR 2.51, 95%CI 1.53,4.12). Conclusions:, In patients with GERD, higher BMI was associated with more severe and more frequent reflux symptoms and esophagitis. [source] Clinical trial: the effects of certolizumab pegol therapy on work productivity in patients with moderate-to-severe Crohn's disease in the PRECiSE 2 studyALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 12 2010B. G. FEAGAN Aliment Pharmacol Ther,31, 1276,1285 Summary Background, The effect of certolizumab pegol on employment status and work productivity has not been previously assessed. Aim, To assess the impact of treatment with certolizumab pegol, the only PEGylated, Fab, TNF antagonist, on work productivity in patients with active Crohn's disease (CD) from the PRECiSE 2 study. Methods, Patients (n = 668) with active disease [CD activity index (CDAI) score of 220,450] were treated with open-label subcutaneous certolizumab pegol 400 mg (week 0, 2, 4). Responders (n = 425) (,100-point decrease in CDAI from baseline) were randomized to receive certolizumab pegol 400 mg or placebo every 4 weeks until week 24, with final evaluation at week 26. Patients completed the Work Productivity and Activity Impairment for CD questionnaire (WPAI:CD) and the Inflammatory Bowel Disease Questionnaire (IBDQ) at weeks 0, 6, 16 and 26 and at the withdrawal visit. Results, Work productivity improved following induction with certolizumab pegol. Between week 6 and 26, certolizumab pegol-treated patients experienced significant improvement in work productivity compared with placebo recipients (11% and 10% overall improvement in work and activity impairment, respectively). During the maintenance phase, impairments in productivity and activities due to CD were significantly less in the certolizumab pegol group than in the placebo group. Conclusion, Induction and maintenance therapy with certolizumab pegol significantly improved the work productivity of patients with active CD compared with those in the placebo group. [source] Adalimumab sustains clinical remission and overall clinical benefit after 2 years of therapy for Crohn's diseaseALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 12 2010R. PANACCIONE Aliment Pharmacol Ther,31, 1296,1309 Summary Background, In the randomized, double-blind, placebo-controlled CHARM trial, adalimumab was more effective than placebo in maintaining clinical remission for patients with moderate-to-severe Crohn's disease (CD) through 56 weeks. Aim, To substantiate the long-term safety and clinical benefits of adalimumab through 2 years of therapy in CHARM and its open-label extension (ADHERE). Methods, Patients entering ADHERE on blinded therapy received adalimumab 40 mg every other week (eow). Patients who had already moved to open-label adalimumab eow or weekly in CHARM continued their regimens. Data were analysed by originally randomized treatment group at CHARM baseline (adalimumab 40 mg eow, adalimumab 40 mg weekly, or placebo), regardless of whether patients entered ADHERE or received open-label adalimumab (eow or weekly). Results, After up to 2 years of therapy, 37.6%, 41.9% and 49.8% of patients originally randomized to placebo, adalimumab eow and adalimumab weekly, respectively, were in clinical remission. All groups experienced sustained improvements on the Inflammatory Bowel Disease Questionnaire. Decreasing hazard rates for both all-cause and CD-related hospitalizations were observed over time. Over a 2-year period, the rates of serious adverse events and malignancies (33.3 and 1.1 events/100-patient-years respectively) were similar to those observed during the overall adalimumab CD clinical development programme. Conclusions, Adalimumab demonstrated sustained maintenance of clinical remission, improvements in quality of life and reductions in hospitalization during long-term treatment for CD, with no new safety concerns identified. [source] Measurement of abdominal symptoms by validated questionnaire: a 3-month recall timeframe as recommended by Rome III is not superior to a 1-year recall timeframeALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 11 2010E. REY Aliment Pharmacol Ther,31, 1237,1247 Summary Background, Rome III incorporates changes in the definition of functional gastrointestinal disorder that involve a 3-month recall time for symptoms, rather than 1-year. Aim, To validate a new version of the Talley-Bowel Disease Questionnaire (Talley-BDQ) and assess the impact of recall time period on the prevalence of symptoms. Methods, A sample of community residents were randomly mailed a survey using 1-year (n = 396) or 3-month recall period (n = 374). We evaluated the reliability and the concurrent validity of the two versions of the questionnaire. The proportions of subjects reporting symptoms in the two versions were compared. Results, The median (IQR) kappa on symptom-related questions was 0.70 (0.57,0.76) from the 1-year version and 0.66 (0.56,0.77) from the 3-month version. A median kappa of 0.39 (0.19,0.70) and 0.58 (0.39,0.73) was observed for concurrent validation of the 1-year and 3-month versions respectively. Except for gastro-oesophageal reflux symptoms, no differences were observed on the prevalence of clinically relevant symptoms. Conclusion, The revised Talley-BDQ is reliable, with excellent reproducibility and validity. There were few differences in reported symptom rates between the 3-month and 1-year recall time versions of the questionnaire. A 1-year recall time may more efficiently capture infrequent or subtle symptoms. [source] Prospective assessment of the effect on quality of life of anti-tumour necrosis factor therapy for perineal Crohn's fistulasALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 7 2009S. C. NG Summary Background, Anti-tumour necrosis factor (TNF) therapy effectively treats Crohn's perineal fistulas (CPF); the effect on health-related quality of life (HRQoL) remains unknown. Aims, To evaluate the effect of anti-TNF therapy on the HRQoL of patients with CPF in daily clinical practice. Methods, Prospective evaluation of clinical and magnetic resonance imaging (MRI) responses, disease activity (Perianal Disease Activity Index , PDAI), and HRQoL assessment [Inflammatory Bowel Disease Questionnaire (IBDQ)] in patients receiving anti-TNF therapy for CPF treated up to 12 months. Results, In all, 26 patients with CPF were treated (mean age 39 years; 19 infliximab, 7 adalimumab). At baseline, 85% patients had impaired IBDQ scores (mean 137; ,normal' >170). At 12 months, mean increases in IBDQ score for infliximab and adalimumab treated patients were 40 and 41 points respectively (P < 0.05). There were significant improvements in all IBDQ subscores (bowel, emotional, systemic, social) at 12 months (all P , 0.003). Fourteen patients (74%) on infliximab and six on adalimumab (86%) achieved IBDQ score ,170. Mean increase in IBDQ score was 50, 34 and 16 points in patients with clinical fistula closure (P < 0.001), clinical response (P = 0.002) and no response (n = 1) respectively. IBDQ score increased for patients with MRI healing (P < 0.001) and MRI improvement (P = 0.016), but not for those with no MRI change (n = 2). IBDQ correlated significantly with PDAI at baseline and at 12 months. Conclusion, Anti-TNF therapy improves HRQoL in patients with CPF at 12 months and this improvement is most pronounced in patients with clinical and MRI healing. [source] Health care seeking for abdominal bloating and visible distentionALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 7 2009X. JIANG Summary Background, While knowledge has accumulated regarding health care seeking in several functional gastrointestinal disorders (FGIDs), little is known about health care seeking in those with bloating and distention. Aim, To identify predictors of health care seeking for bloating and distention. Methods, The validated Talley Bowel Disease Questionnaire was mailed to a cohort selected at random from the population of Olmsted County, Minnesota; 2259 subjects (53% females; mean age 62 years) answered questions about bloating and distention. The complete medical record of each respondent was reviewed. Logistic regression was used to compare consulting for bloating and distention with consulting for other GI symptoms, and nonconsulters. Results, A total of 131 (6%) subjects in the community consulted a physician for bloating or distention. Older age [odds ratio (OR), 1.8; 95% confidence interval (CI): 1.5, 2.1], higher somatic symptom scores (OR, 2.0; CI: 1.4, 2.8), lower education level (OR, 2.7; CI: 1.2, 5.6), early satiety (OR, 2.0; CI: 1.1, 3.8) and abdominal pain (OR, 2.4; CI: 1.6, 3.7) were associated with people seeking health care for bloating or distention vs. non-consulters. Similarly, older age (OR, 1.4; CI: 1.2, 1.7), chronic constipation (OR, 2.0; CI: 1.2, 3.2) and visible distention (OR, 3.0; CI: 1.8, 4.9) had greater odds of presenting for bloating or distention compared with presenting for other GI symptoms; somatic symptoms were not a predictor (OR, 1.1; CI: 0.8, 1.5). Conclusions, Factors that lead people to present for bloating and distention are similar to those for other GI symptoms visits; however, specific biological rather than somatic features may predict visits for bloating and distention. [source] Validation of a 7-point Global Overall Symptom scale to measure the severity of dyspepsia symptoms in clinical trialsALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 4 2006S. J. O. VELDHUYZEN VAN ZANTEN Summary Background, Currently there is no consensus on the optimal method to measure the severity of dyspepsia symptoms in clinical trials. Aim, To validate the 7-point Global Overall Symptom scale. Methods, The Global Overall Symptom scale uses a 7-point Likert scale ranging from 1 = no problem to 7 = a very severe problem. Validation was performed in two randomized-controlled trials (n = 1121 and 512). Construct validity: Global Overall Symptom was compared with the Quality of Life in Reflux And Dyspepsia, Gastrointestinal Symptom Rating Scale, Reflux Disease Questionnaire and 10 specific symptoms using Spearman correlation coefficients. Test,retest reliability: The Intraclass Correlation Coefficient was calculated for patients with stable dyspepsia defined by no change in Overall Treatment Effect score over two visits. Responsiveness: effect size and standardized response mean were also calculated. Results, Construct validity: Change in Global Overall Symptom score correlated significantly with Quality of Life for Reflux And Dyspepsia, Gastrointestinal Symptom Rating Scale, Reflux Disease Questionnaire and specific symptoms (all P < 0.0002). Reliability: The Intraclass Correlation Coefficient was 0.62 (n = 205) and 0.42 (n = 270). Responsiveness: There was a positive correlation between change in Global Overall Symptom and change in symptom severity. The effect size and standardized response mean were 1.1 and 2.1, respectively. Conclusion, The Global Overall Symptom scale is a simple, valid outcome measure for dyspepsia treatment trials. [source] Validity of the Spanish version of the Chronic Liver Disease Questionnaire (CLDQ) as a standard outcome for quality of life assessment,LIVER TRANSPLANTATION, Issue 1 2006Montserrat Ferrer The Chronic Liver Disease Questionnaire (CLDQ) measures the impact on quality of life of chronic liver diseases, regardless of underlying etiology. The aim of this study was to develop a Spanish version of the CLDQ, and to assess its acceptability, reliability, validity, and sensitivity to change. The forward and back-translation method by bilingual translators, with expert panel and pilot testing on patients, was used for the adaptation. The final version was self-administered, together with the Short Form-36 Health Survey (SF-36), on 149 consecutive patients with chronic liver disease. Child-Turcotte-Pugh scores were evaluated by a physician. To assess reproducibility and responsiveness the CLDQ was readministered to a subsample of stable patients and to those who had received a liver transplant. Validity was evaluated via exploratory factor analysis, the CLDQ pattern across severity groups, and correlation coefficients with "itching" and SF-36 scores. Cronbach's alpha and Intraclass Correlation Coefficient for CLDQ global score were 0.93 and 0.90, respectively, demonstrating good reliability. Validity was supported by correlations of the CLDQ with SF-36 and "itching," and CLDQ severity gradient (global score means were 5.5, 5.2, 5.0, and 4.5 in patients with no cirrhosis, cirrhosis Child-Turcotte-Pugh A, B, and C, respectively; P = 0.012). Responsiveness was shown by a high CLDQ improvement in patients who had received liver transplant (mean change = ,1.4; P < 0.001). In conclusion, the Spanish CLDQ is reliable, valid, responsive, and equivalent to the original. These findings support its use as a standard outcome for patients with chronic liver diseases within the whole severity range, from "no cirrhosis" to transplant recipients, both in Spanish and international studies. Liver Transpl 12:95,104, 2006. © 2005 AASLD. [source] Restless legs syndrome in Parkinson's diseaseMOVEMENT DISORDERS, Issue 13 2007Juan C. Gómez-Esteban MD Abstract The present study explores the frequency of RLS in PD and focuses on the clinical differences between patients with and without restless legs syndrome (RLS). A cross-sectional study was designed, comprising 114 patients diagnosed with PD. Those patients positive for RLS were assessed for intensity of the syndrome (IRLS). We compared the clinical characteristics of the patients with and without RLS, using specific scales: Unified Parkinson's Disease Rating Scale (UPDRS I-IV), quality of life (Parkinson's Disease Questionnaire, PDQ 39), sleep symptoms (Parkinson's Disease Sleep Scale, PDSS), and diurnal hypersomnia (Epworth Sleepiness Scale). Twenty-five patients (21.9%) out of a total of 114 subjects diagnosed with PD met the RLS diagnostic criteria. RLS was more frequent in women (68%). The patients with RLS showed poorer scores on the PDSS (PD-RLS+: 102.4 ± 15.1 vs PD-RLS-: 113.2 ± 16.4) (P = 0.005) and in the bodily discomfort dimension of the PDQ-39 (PD-RLS+ 6.1 ± 3.4 vs PD-RLS- 3.8 ± 2.6) (P = 0.002). Analysis of the subscales of the PDSS showed significant differences (P < 0.001) between both groups of patients in items 4 and 10, and to a lesser degree in items 5 (P = 0.01) and 11 (P = 0.02) There was no increased incidence of diurnal hypersomnia in the group of patients with RLS. There were no differences in the rest of the variables. RLS is frequent in patients with PD, though this condition doesn't apparently affect quality of life or lead to an increased presence of diurnal hypersomnia. It would be advisable to validate the diagnostic criteria of RLS in this specific group of patients. © 2007 Movement Disorder Society [source] Evaluation of acupuncture in the treatment of Parkinson's disease: A double-blind pilot studyMOVEMENT DISORDERS, Issue 9 2005Adrian Cristian MD Abstract As many as 40% of patients with Parkinson's disease (PD) use some form of complementary medicine during the course of their illness, and many try acupuncture. One nonblinded study of the effects of acupuncture in PD suggested that it might be helpful for some aspects of PD. We performed a double-blind, randomized, pilot study comparing acupuncture to a control nonacupuncture procedure to determine the effects of acupuncture upon a variety of PD-associated symptoms. Fourteen patients with Stage II or III PD received acupuncture or a control nonacupuncture protocol. Before and after treatment, patients were evaluated using the Motor subscale of the Unified Parkinson's Disease Rating Scale (UPDRS), the Parkinson's Disease Questionnaire (PDQ-39), and the Geriatric Depression Scale. There were no statistically significant changes for the outcomes measured. In the patients who received acupuncture, nonsignificant trends toward improvement were noted in the Activities of Daily Living score of the PDQ-39, the PDQ-39 Summary Index, and the Motor subscale of the UPDRS. © 2005 Movement Disorder Society [source] Quality of life in Polish patients with long-lasting Parkinson's diseaseMOVEMENT DISORDERS, Issue 6 2004Marcin, ach MD Abstract The objective of this study was to evaluate possible relationships between quality of life (QoL) of Polish patients with long-lasting Parkinson's disease and various demographic and clinical factors. The study comprised 141 patients of Movement Disorders outpatient clinics in Warsaw and Gdansk with at least 5 years of the disease duration. Mean age of patients was 68.09 ± 8.51 years, mean duration of disease was 11.87 ± 5.14 years. To assess the quality of life, the Parkinson's Disease Questionnaire (PDQ-39) was used. Additional questions concerned duration of disease, initial and current treatment and expenses associated with therapy. Self-perceived symptoms of depression were in our study the most important factor determining QoL. Duration of the disease and expenses related to the treatment also have a significant impact on the QoL. Patient's age and presence of dyskinesia seem to be irrelevant to the quality of life. © 2003 Movement Disorder Society [source] Creatine supplementation for patients with COPD receiving pulmonary rehabilitation: A systematic review and meta-analysisRESPIROLOGY, Issue 5 2010Fahad AL-GHIMLAS ABSTRACT Background and objective: Creatine improves muscle strength in exercising healthy individuals, and in patients with neuromuscular disease and heart failure. The aim of this study was to assess whether creatine supplementation improves pulmonary rehabilitation (PR) outcomes in patients with COPD. Methods: A systematic review and meta-analysis was performed of randomized controlled trials published between January 1966 and February 2009 that evaluated the effect of creatine compared with placebo on exercise capacity, muscle strength and health-related quality of life (HR-QoL) in patients undergoing PR for COPD. The pooled estimates were expressed as mean differences (MD) or standardized mean differences (SMD). Results: Four randomized controlled trials that included 151 patients were identified. There was no effect of creatine supplementation on exercise capacity (SMD ,0.01, 95% CI: ,0.42 to 0.22, n = 151). Creatine supplementation did not improve lower extremity muscle strength (SMD 0.03, 95% CI: ,0.55 to 0.61, n = 140) or upper limb muscular strength (SMD 0.02, 95% CI: ,0.33 to 0.38, n = 128) compared with placebo. Two studies (n = 48) assessed quality of life using the St. George's Respiratory Disease Questionnaire. There were no differences in HR-QoL according to domain or total scores. Overall, creatine appeared to be safe and was well tolerated. Quality assessment of the studies showed important limitations. Conclusions: Creatine supplementation does not improve exercise capacity, muscle strength or HR-QoL in patients with COPD receiving PR. However, important limitations were identified in the quality of the available evidence, suggesting that further research is required in this area. [source] Validation of the Clinical COPD Questionnaire as a psychophysical outcome measure in adult laryngotracheal stenosisCLINICAL OTOLARYNGOLOGY, Issue 4 2009S.A.R. Nouraei Objectives:, To validate the Clinical Chronic Obstructive Pulmonary Disease Questionnaire (CCQ), a patient-administered instrument developed for bronchopulmonary disease as a disease-specific psychophysical outcome measure for adult laryngotracheal stenosis. Design:, Prospective observational study. Settings:, Tertiary/National referral airway reconstruction centre. Participants:, Thirty-three tracheostomy-free patients undergoing endoscopic laryngotracheoplasty. Main outcome measures:, CCQ and the Medical Research Council (MRC) Dyspnoea scale, a previously validated but more limited scale, were administered to patients 2 weeks before surgery, preoperatively, and 2 weeks after endoscopic laryngotracheoplasty. Pulmonary function was assessed preoperatively. Internal consistency was assessed with Cronbach , statistics and test,retest reliability was determined using intraclass correlation. Correlations between CCQ and MRC scale, and pulmonary function were used to assess convergent and divergent validity respectively. Instrument responsiveness was assessed by correlating total and domain-specific CCQ scores with anatomical disease severity and post-treatment effect size. Results:, There were 12 males and 21 females. Mean age was 44 ± 15 years. Cronbach , coefficient and intraclass correlation coefficient were 0.88 and 0.95 respectively. Total and domain-specific CCQ scores significantly correlated with the MRC scores (P < 0.001) and significant correlations between CCQ and peak expiratory flow rate and FEV1 were identified (P < 0.03). There were statistically significant changes in total and domain-specific CCQ scores when different stenosis severities were compared. Clinical COPD Questionnaire scores also changed significantly and congruently following surgery (P < 0.05 in both cases). Discussion:, Clinical COPD Questionnaire is a valid and sensitive instrument for assessing symptom severity and levels of function and well-being in adult patients with laryngotracheal stenosis and can be used as a patient-centred disease-specific outcome measure for this condition. [source] Comparison of Short Form-36 Health Survey and Nottingham Health Profile in moderate to severe patients with COPDJOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 4 2008Sevgi Ozalevli Abstract Objective, To compare the health-related quality of life (HRQoL) assessed by Short Form-36 Health Survey (SF-36) and Nottingham Health Profile (NHP) on the basis of lung function and exercise capacity parameters in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Methods and materials, The investigation was a prospective, quality-of-life survey and cross-sectional study of 130 consecutive COPD patients. The NHP and SF-36 as generic HRQoL instruments, the Chronic Respiratory Disease questionnaire (CRQ) as a disease-specific HRQoL instrument and 6-minute walking test, severity of dyspnea, leg fatigue and lung function, were the measurements and instruments used in the study. Results, It was determined that the subscales of both questionnaires were generally related with the FEV1, walking distance, CRQ, severity of dyspnea and leg fatigue values (P < 0.05). The much higher correlation coefficient was determined between these parameters and NHP compared with the SF-36. Only NHP was found to be correlated with the age, body mass index and smoking consumption (P < 0.05). Conclusions, The stronger relation of NHP with the clinical and physical parameters of the patients compared with that of SF-36 may be associated with the increased sensitivity of NHP to the clinical state owing to the increasing respiratory symptoms of our old patients with moderate to severe obstruction and/or the more intelligible and easy-to-respond nature of NHP compared with SF-36. [source] Validation of interactive voice response system administration of the short inflammatory bowel disease questionnaireINFLAMMATORY BOWEL DISEASES, Issue 4 2009Manuel Y. Lam BA Abstract Background: The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a written, self-administered instrument measuring quality of life in IBD. We assessed the validity of an interactive voice response system (IVRS) as a new mode of administering the SIBDQ. Methods: An IVRS was designed using prerecorded questions to collect data via touchtone telephone. Subjects with Crohn's disease (CD) or ulcerative colitis (UC) were randomized into 2 groups with different orders of administration: written, self-administered followed by IVRS (S-I) or IVRS followed by written, self-administered (I-S). Half of the S-I group was also randomized to receive a second IVRS. Sixty-four subjects were studied: 30 in S-I, 34 in I-S. Results: The mean SIBDQ scores were not different between written and IVRS modes (P = 0.26) with r = 0.93. IVRS scores were lower in active than inactive CD (36.1 ± 9.6 versus 54.7 ± 8.6, P < 0.001) and lower in active than inactive UC (40.8 ± 9.6 versus 59.8 ± 10.0, P < 0.001). Mean scores correlated highly with disease activity indices, and were not different between first and second IVRS administrations (P = 0.85) with r = 0.92. IVRS had excellent internal consistency (Cronbach alpha = 0.90). Conclusions: IVRS administration of the SIBDQ yields results similar to written self-administration, with excellent procedural validity, test,retest reliability, and internal consistency. (Inflamm Bowel Dis 2009) [source] Symptom overlap in patients with upper gastrointestinal complaints in the Canadian confirmatory acid suppression test (CAST) study: further psychometric validation of the reflux disease questionnaireALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 9 2007S. V. VAN ZANTEN Summary Background The reflux disease questionnaire (RDQ) is a short, patient-completed instrument. Aims To investigate the psychometric characteristics of the RDQ in patients with heartburn-predominant (HB) and non-heartburn predominant (NHB) dyspepsia. Methods HB (n = 388) and NHB (n = 733) patients were randomized to esomeprazole 40 mg daily or twice daily for 1 week, followed by 3 weeks of esomeprazole 40 mg daily. Results High factor loadings (0.78,0.86) supported the ,regurgitation' dimension of the RDQ. Overlapping factor loadings in the ,heartburn' and ,dyspepsia' dimensions suggested symptom overlap. All dimensions demonstrated high internal consistency (Cronbach's alpha: 0.79,0.90). Intra-class correlation coefficients over 4 weeks were good (0.66,0.85). The RDQ showed good responsiveness over 4 weeks of treatment, with high effect sizes (,0.80). Moderate or large symptom improvements were reported by 90% and 77% of HB and NHB patients, respectively, following treatment. Patients who responded to acid suppression also experienced symptom benefits in all RDQ dimensions. Conclusions The RDQ is reliable, valid and responsive to change in HB and NHB patients. The symptom overlap is important but need not play a major role in determining treatment strategy as both patient groups benefited from proton pump inhibitor treatment. [source] Do we need a new gastro-oesophageal reflux disease questionnaire?ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 5 2004V. Stanghellini Summary Background :,Gastro-oesophageal reflux disease (GERD) is highly prevalent in Western countries. Because the majority of patients do not present with endoscopic abnormalities, the assessment of the symptom severity and quality of life, and their response to treatment, has become increasingly important. Self-assessed symptom questionnaires are now key instruments in clinicaltrials. Aim :,To evaluate the validity of available GERD measurement tools. Methods :,An ideal GERD symptom assessment instrument, suitable as a primary end-point for clinical trials, should possess the following characteristics: (i) be sensitive in patients with GERD; (ii) cover the frequency and intensity of typical and atypical GERD symptoms; (iii) be multidimensional (cover all symptom dimensions); (iv) have proven psychometric properties (validity, reliability and responsiveness); (v) be practical and economical; (vi) be self-assessed; (vii) use ,word pictures' which are easy to understand for patients; (viii) respond rapidly to changes (responsiveness over short time intervals); (ix) be used daily to assess changes during and after therapy; and (x) be valid in different languages for international use. Results :,A literature review revealed five scales that met some of the above characteristics, but did not fulfil all criteria. Conclusion :,There is a need for a new evaluative tool for the assessment of GERD symptoms and their response to therapy. [source] Gabapentin can improve postural stability and quality of life in primary orthostatic tremorMOVEMENT DISORDERS, Issue 7 2005Julian P. Rodrigues MD Abstract Primary orthostatic tremor (OT) is characterized by leg tremor and instability on standing. High frequency (13,18 Hz) tremor bursting is present in leg muscles during stance, and posturography has shown greater than normal sway. We report on an open-label add-on study of gabapentin in 6 patients with OT. Six patients were studied with surface electromyography, force platform posturography, and a modified Parkinson's disease questionnaire (PDQ-39) quality of life (QOL) scale before and during treatment with gabapentin 300 mg t.d.s. If on other medications for OT, these were continued unchanged. Of the 6 patients, 4 reported a subjective benefit of 50 to 75% with gabapentin, 3 of whom showed reduced tremor amplitude and postural sway of up to 70%. Dynamic balance improved in all 3 patients who completed the protocol. QOL data from 5 patients showed improvement in all cases. No adverse effects were noted. Gabapentin may improve tremor, stability, and QOL in patients with OT, and symptomatic response correlated with a reduction in tremor amplitude and postural sway. The findings confirm previous reports of symptomatic benefit with gabapentin and provide justification for larger controlled clinical trials. Further work is required to establish the optimal dosage and to validate the methods used to quantify the response to treatment. © 2005 Movement Disorder Society [source] | ||||||||||