randomisation schedule (Pfizer Inc)
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Randomisation Schedule, supplied by Pfizer Inc, used in various techniques. Bioz Stars score: 86/100, based on 1 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
https://www.bioz.com/product/randomisation+schedule/randomisation+schedule/10__1002_slash_14651858__cd003781__pub3-3026-38-47
Average 86 stars, based on 1 article reviews
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Generated:Article Title: Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults Article Snippet: .. We judged two studies to be high risk of bias as "the Article Title: Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults Article Snippet: Cochrane Database of Systematic Reviews Group II (n = 448): fesoterodine 4 mg once daily per oral, could choose to increase to 8 mg at the end of 2 weeks Placebo run-in for 2 weeks Treatment for 12 weeks Outcomes Change from baseline in the mean number of micturitions per 24 hours Bladder diary variables Quality of life using OAB-q Proportion of patients reporting improvement on PPBC and Urgency Perception Scale (UPS); PPBC: ≥ 2-point improvement, 1 point improvement, no change or deterioration from baseline UPS: improvement, no change, deterioration) Percentage change for bladder diary variables Adverse events, BP and heart rate Study funding sources Study funded by Pfizer Notes 116 dropouts (Group I: 60, Group II: 56) Last observation carried forward for missing values; ITT principle used Standard error converted to standard deviation OAB-q data, urgency episodes and UUI episodes per 24 hours were not useable as reported as least square mean change with no standard deviation .. Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Low risk Randomisation implemented using central system accessed by phone or internet that generated single participant identification and randomisation numbers Allocation concealment (selection bias) High risk The Article Title: Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults Article Snippet: .. Our decision to rate ‘allocation concealment’ as high risk of bias in the studies that involved conflict of interest was based on the fact that the Article Title: Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults Article Snippet: Cochrane Database of Systematic Reviews 12-week study period Outcomes Primary outcome: change from baseline in urge urinary incontinence at week 12 Secondary outcomes: change from baseline in the number of micturitions per day, and urgency episodes per day PPBC and Urgency Perception Scale Change in QoL evaluated by OAB-q questionnaire Urinary diary activity assessment, questionnaire to evaluate QoL at week 0, 4 and 12 Adverse events, vital signs and PVR Study funding sources Study supported by Pfizer Notes — .. Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Low risk Centralised randomisation system, generated, secured and distributed by Pfizer Global Clinical Data Services Allocation concealment (selection bias) High risk The Article Title: Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults Article Snippet: .. Cochrane Database of Systematic Reviews Allocation concealment (selection bias) Low risk Pfizer generated and secured the Sequencing:Article Title: Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults Article Snippet: Cochrane Database of Systematic Reviews Group II (n = 448): fesoterodine 4 mg once daily per oral, could choose to increase to 8 mg at the end of 2 weeks Placebo run-in for 2 weeks Treatment for 12 weeks Outcomes Change from baseline in the mean number of micturitions per 24 hours Bladder diary variables Quality of life using OAB-q Proportion of patients reporting improvement on PPBC and Urgency Perception Scale (UPS); PPBC: ≥ 2-point improvement, 1 point improvement, no change or deterioration from baseline UPS: improvement, no change, deterioration) Percentage change for bladder diary variables Adverse events, BP and heart rate Study funding sources Study funded by Pfizer Notes 116 dropouts (Group I: 60, Group II: 56) Last observation carried forward for missing values; ITT principle used Standard error converted to standard deviation OAB-q data, urgency episodes and UUI episodes per 24 hours were not useable as reported as least square mean change with no standard deviation .. Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Low risk Randomisation implemented using central system accessed by phone or internet that generated single participant identification and randomisation numbers Allocation concealment (selection bias) High risk The Article Title: Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults Article Snippet: Cochrane Database of Systematic Reviews 12-week study period Outcomes Primary outcome: change from baseline in urge urinary incontinence at week 12 Secondary outcomes: change from baseline in the number of micturitions per day, and urgency episodes per day PPBC and Urgency Perception Scale Change in QoL evaluated by OAB-q questionnaire Urinary diary activity assessment, questionnaire to evaluate QoL at week 0, 4 and 12 Adverse events, vital signs and PVR Study funding sources Study supported by Pfizer Notes — .. Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Low risk Centralised randomisation system, generated, secured and distributed by Pfizer Global Clinical Data Services Allocation concealment (selection bias) High risk The Selection:Article Title: Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults Article Snippet: Cochrane Database of Systematic Reviews Group II (n = 448): fesoterodine 4 mg once daily per oral, could choose to increase to 8 mg at the end of 2 weeks Placebo run-in for 2 weeks Treatment for 12 weeks Outcomes Change from baseline in the mean number of micturitions per 24 hours Bladder diary variables Quality of life using OAB-q Proportion of patients reporting improvement on PPBC and Urgency Perception Scale (UPS); PPBC: ≥ 2-point improvement, 1 point improvement, no change or deterioration from baseline UPS: improvement, no change, deterioration) Percentage change for bladder diary variables Adverse events, BP and heart rate Study funding sources Study funded by Pfizer Notes 116 dropouts (Group I: 60, Group II: 56) Last observation carried forward for missing values; ITT principle used Standard error converted to standard deviation OAB-q data, urgency episodes and UUI episodes per 24 hours were not useable as reported as least square mean change with no standard deviation .. Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Low risk Randomisation implemented using central system accessed by phone or internet that generated single participant identification and randomisation numbers Allocation concealment (selection bias) High risk The Article Title: Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults Article Snippet: Cochrane Database of Systematic Reviews 12-week study period Outcomes Primary outcome: change from baseline in urge urinary incontinence at week 12 Secondary outcomes: change from baseline in the number of micturitions per day, and urgency episodes per day PPBC and Urgency Perception Scale Change in QoL evaluated by OAB-q questionnaire Urinary diary activity assessment, questionnaire to evaluate QoL at week 0, 4 and 12 Adverse events, vital signs and PVR Study funding sources Study supported by Pfizer Notes — .. Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Low risk Centralised randomisation system, generated, secured and distributed by Pfizer Global Clinical Data Services Allocation concealment (selection bias) High risk The Article Title: Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults Article Snippet: .. Cochrane Database of Systematic Reviews Allocation concealment (selection bias) Low risk Pfizer generated and secured the |
