Clinically meaningful versus clinically significant

    • [DOC File]Running Head: EFFICACY OF BIOFEEDBACK FOR TENSION …

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      The more common but less disabling episodic tension-type headache (ETTH) is estimated with a one-year prevalence of 38%, while the prevalence of chronic tension-type headache (CTTH), defined as having a frequency of at least 15 days per month, is estimated at 2%-3% (Schwartz, Steward, Simon & Lipton, 1998).


    • [DOCX File]About ICER - Home - ICER

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      A change of one light level in passing was considered clinically meaningful by the sponsor. 9 The results show that participants treated with VN saw a difference of 1.6 (95% CI, 0.72 to 2.41) in their bilateral MLMT change score at one year compared to no treatment (original intervention arm score improvement of 1.8, control arm score ...


    • [DOCX File]Attachment: Extract from Clinical Evaluation: Indacaterol ...

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      The proportion of patients with a clinically meaningful improvement in the SGRQ total score (≥ 4 point reduction) was higher in the QVA149 arm compared to the salmeterol/fluticasone arm from Day 85 onwards (49.2% versus 43.7%, odds ratio 1.30 …


    • [DOC File]Silodosin Drug Monograph - Pharmacy benefit management

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      No clinically meaningful changes occurred with respect to laboratory tests or ECGs in any of the treatment groups. Silodosin did not cause a statistically significant change from baseline in BP or HR when compared to placebo; however, tamsulosin caused a small but statistically significant difference vs. placebo.


    • [DOC File]RELEVANT END-POINTS AND OUTCOME VARIABLES – WHAT …

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      Substituting surrogate end-points for the target event offers an apparent solution to the dilemma. A surrogate end-point can be defined as a laboratory measurement or a physical sign used as a substitute for a clinically meaningful end-point that measures directly how a patient feels, functions or survives [9].


    • Statistical Versus Clinical Significance in Psychiatry

      These measures are also useful in interpreting the results presented as dichotomous outcomes in clinically meaningful terms. Absolute risk reduction is equal to …


    • [DOCX File]www.pbm.va.gov

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      The exception was for nonfatal MI where the adjusted event rate was 7.4 for UMEC/VI 62.5/25 and 2.7 for placebo (number of events was 3 and 1 respectively). Patients who had any clinically significant uncontrolled CV-related disease, abnormal clinically significant ECG, or 24-h Holter ECG were excluded from the clinical trials.


    • [DOC File]“Clinically complex” refers to illnesses and medical ...

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      Clinical judgment by members of the Clinical Resource Group was used to identify and define clinically meaningful dimensions of case mix, factoring in findings from the literature and the results from the regressions. Policy implications of alternative variables or structures were considered. Additional variables were assessed for


    • [DOCX File]Attachment 1. Product Information for Trajenta

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      Attachment 1: Product information for AusPAR Trajenta Linagliptin Boehringer Ingelheim Pty Ltd PM-2012-01168 ... Linagliptin once daily produced clinically significant improvements in glycaemic control, with no clinically relevant change in body weight. ... Clinical data described below suggest that the risk for clinically meaningful ...


    • [DOC File]THE DIAGNOSIS AND TREATMENT OF PARKINSON’S DISEASE

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      The motor features of Parkinson's disease can be controlled reasonably well in most patients with the measures outlined above. It is the non-motor features of the disorder which now present the greatest management challenge, including dementia, psychosis, imbalance and falls, autonomic dysfunction, sleep disorders, and pain.


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