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Patient Global Impression (patient + global_impression)
Selected AbstractsComparison between reduction in 24-hour pad weight, International Consultation on Incontinence-Short Form (ICIQ-SF) score, International Prostate Symptom Score (IPSS), and Post-Operative Patient Global Impression of Improvement (PGI-I) score in patient evaluation after male perineal slingNEUROUROLOGY AND URODYNAMICS, Issue 1 2007Christian O. Twiss Abstract Aims We assessed the utility of three self-assessment instruments: the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), the post-operative Patient Global Impression of Improvement (PGI-I) score, and the International Prostate Symptom Score (IPSS) by correlating them with an objective outcome, the change in 24-hr pad weight, after a male perineal sling. Methods Twenty-six men with urodynamically confirmed stress incontinence underwent a male perineal sling. Patients were evaluated pre-operatively and post-operatively with a 24-hr pad test, IPSS and ICIQ-SF. Patients also completed the PGI-I post-operatively. Changes in study parameters were compared via the paired t -test, and correlations were performed using Spearman's rho. Results There were significant reductions in 24-hr pad weight (,274 g, P,<,0.001), percentage 24-hr pad weight (54.2%), ICIQ-SF score (,6.3, P,<,0.001), and the three ICIQ-SF subscores (,1.2, ,1.7, ,3.4 for Questions 3, 4, and 5, respectively, P,<,0.001 for all). The change in total ICIQ-SF score and the post-operative PGI-I score correlated strongly with percentage reduction in 24-hr pad weight (r,=,,0.68, P,<,0.001; r,=,,0.81, P,<,0.001, respectively) and with each other (r,=,0.79, P,<,0.001). The change in all three ICIQ-SF subscores correlated significantly with percentage reduction in 24-hr pad weight and with post-operative PGI-I score. There was no significant change in the IPSS or the voiding or storage subscores, and none correlated with any other study parameter. Conclusions This study validates the construct validity of the ICIQ-SF and PGI-I in the assessment of treatment for male stress incontinence and should make clinicians confident in comparing studies of incontinence treatment utilizing the change ICIQ-SF score, the post-operative PGI-I score, and percentage reduction in 24-hr pad weight as outcome measures. Neurourol. Urodynam. © 2006 Wiley-Liss, Inc. [source] Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: A randomized, double-blind, placebo-controlled, multicenter clinical trial,ARTHRITIS & RHEUMATISM, Issue 1 2009I. Jon Russell Objective To evaluate the safety and efficacy of sodium oxybate for management of the symptoms of fibromyalgia syndrome (FMS). Methods Patients with FMS (according to the American College of Rheumatology 1990 criteria) were randomized, after discontinuing their prestudy medications for FMS, to receive 4.5 gm or 6 gm of sodium oxybate or matching placebo once per night for 8 weeks. The primary outcome variable (POV) was a composite score for changes from baseline in 3 coprimary self-report measures: patient's pain rating (in daily electronic diaries) on a visual analog scale (PVAS), the Fibromyalgia Impact Questionnaire (FIQ) score, and the Patient Global Impression of Change (PGI-C). A beneficial response rate for the POV composite score was defined as ,20% improvement in the PVAS and FIQ scores plus a rating of "much better" or "very much better" on the PGI-C. Secondary measures included subjective sleep outcomes (on the Jenkins Scale for Sleep) and quality-of-life measures. The analyses were based on an intent-to-treat (ITT) population. Results The ITT population included 188 patients with FMS, 78% of whom completed the trial. Significant benefit was observed with both dosages of sodium oxybate, according to changes in the POV and subjective sleep quality. Improvements in the PVAS score were significantly correlated with sleep outcomes. Sodium oxybate was well tolerated overall; dose-related nausea (,28% of patients) and dizziness (,18% of patients) tended to resolve with continued therapy. Conclusion Sodium oxybate therapy was well tolerated and significantly improved the symptoms of FMS. Further study of sodium oxybate as a novel therapeutic option for FMS is warranted. [source] Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: Results of a randomized, double-blind, placebo-controlled trial,ARTHRITIS & RHEUMATISM, Issue 9 2010Lesley M. Arnold Objective To assess the efficacy and safety of milnacipran at a dosage of 100 mg/day (50 mg twice daily) for monotherapy treatment of fibromyalgia. Methods A double-blind, placebo-controlled trial was performed to assess 1,025 patients with fibromyalgia who were randomized to receive milnacipran 100 mg/day (n = 516) or placebo (n = 509). Patients underwent 4,6 weeks of flexible dose escalation followed by 12 weeks of stable-dose treatment. Two composite responder definitions were used as primary end points to classify the response to treatment. The 2-measure composite response required achievement of ,30% improvement from baseline in the pain score and a rating of "very much improved" or "much improved" on the Patient's Global Impression of Change (PGIC) scale. The 3-measure composite response required satisfaction of these same 2 improvement criteria for pain and global status as well as improvement in physical function on the Short Form 36 (SF-36) physical component summary (PCS) score. Results After 12 weeks of stable-dose treatment, a significantly greater proportion of milnacipran-treated patients compared with placebo-treated patients showed clinically meaningful improvements, as evidenced by the proportion of patients meeting the 2-measure composite responder criteria (P < 0.001 in the baseline observation carried forward [BOCF] analysis) and 3-measure composite responder criteria (P < 0.001 in the BOCF). Milnacipran-treated patients also demonstrated significantly greater improvements from baseline on multiple secondary outcomes, including 24-hour and weekly recall pain score, PGIC score, SF-36 PCS and mental component summary scores, average pain severity score on the Brief Pain Inventory, Fibromyalgia Impact Questionnaire total score (all P < 0.001 versus placebo), and Multidimensional Fatigue Inventory total score (P = 0.036 versus placebo). Milnacipran was well tolerated by most patients, with nausea being the most commonly reported adverse event (placebo-adjusted rate of 15.8%). Conclusion Milnacipran administered at a dosage of 100 mg/day improved pain, global status, fatigue, and physical and mental function in patients with fibromyalgia. [source] Randomised prospective single-blinded study comparing ,inside-out' versus ,outside-in' transobturator tapes in the management of urodynamic stress incontinence: 1-year outcomes from the E-TOT studyBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 7 2010M Abdel-fattah Please cite this paper as: Abdel-fattah M, Ramsay I, Pringle S, Hardwick C, Ali H, Young D, Mostafa A. Randomised prospective single-blinded study comparing ,inside-out' versus ,outside-in' transobturator tapes in the management of urodynamic stress incontinence: 1-year outcomes from the E-TOT study. BJOG 2010;117:870,878. Objective, To compare the ,inside-out' versus ,outside-in' routes for transobturator tape insertion for urodynamic stress incontinence, and to identify independent risk factors for failure at 1 year. Design, Prospective single-blinded randomised trial. Setting, Tertiary urogynaecology centre. Population, A cohort of 341 women undergoing transobturator tape procedures between April 2005 and April 2007. Methods, Women were randomised to tension-free vaginal tape-obturator (TVT)-OÔ for the ,inside-out' route (n = 170) and transobturator tape (TOT)-ARIS® for the ,outside-in' route (n = 171). Participants completed validated symptom-severity, quality-of-life and sexual-function questionnaires before and after surgery. In addition, they completed the patient global impression of improvement questionnaire (PGI-I) and standard 1-hour pad test postoperatively. Main outcome measures, The primary outcome was the patient-reported success rate reported on the PGI-I scale. Secondary outcomes included objective cure rate and improvement in King's Health Questionnaire scores. Results, A total of 341 women were recruited: 171 women to the ,outside-in' (TOT-ARIS®) group and 170 to the ,inside-out' (TVT-OÔ) group; 299 completed the 1-year follow up. The patient-reported success rate was 80% with no statistically significant differences between the groups (,outside-in' 77.6% versus ,inside-out' 81.2%; OR 1.25; 95% CI 0.71, 2.20; P = 0.54). The objective cure rate was 91% with no statistically significant difference between the groups (,outside-in' 88% versus ,inside-out' 94%; OR 2.21; 95% CI 0.85, 5.75; P = 0.157). Previous incontinence surgery (OR 1.41; 95% CI 1.18, 1.91; P = 0.029) and preoperative urgency incontinence (OR 1.78; 95% CI 1.21, 3.91, P = 0.048) were significant risk factors for failure of transobturator tape at the 1-year follow up. Conclusions, There are no significant differences in patient reported and objective cure rates between ,inside-out' and ,outside-in' transobturator tapes. Quality of life and sexual function significantly improved following surgery. Both previous incontinence surgery and preoperative urgency incontinence are associated with significantly lower patient-reported cure rates. 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