*Include nature of measure and magnitude of effect observed Observational studies Reference Quality Design Sample Study Dose Health Effect Stat sig Clin score size outcome size* sig† *Include nature of measure (e.g. hazard ratio, relative risk, odds ratio) and magnitude of effect observed Y(d>0.5), J (<d=0.5 but justifiable), N (d<0.5 not justifiable). If J, justification MUST †Insert be provided in Section 6. number of statistically significant positive studies Total number of statistically and clinically significant positive studies High quality studies (Quality Score 8-16) Lower quality studies (Quality Score 0-7) No (%) SS* No ( %) not-SS* No (%) SS* No ( %) not-SS* *SS = Statistically Significant positive outcome Estimate of Clinical Impact Excellent Good Satisfactory Poor Clinical Meaningful health Meaningful health Impact on target impact benefit very likely benefit likely to be population to achieved by achieved by uncertain- health consumers consumers benefit possible. 6. BALANCE OF EVIDENCE (Section 3.2.1.9) Element Excellent Good Acceptable Unacceptable Consistency All high quality Most high High quality studies Inconsistent studies show SS quality studies equivocal, lower (equivocal) or positive effect show SS positive quality studies negative effect effect mostly consistent
*Include nature of measure and magnitude of effect observed Observational studies Reference Quality score Design Sample size Study Dose Health outcome Effect size* Stat sig Clin sig† *Include nature of measure (e.g. hazard ratio, relative risk, odds ratio) and magnitude of effect observed †Insert Y(d>0.5), J (<d=0.5 but justifiable), N (d<0.5 not justifiable). If J, justification MUST be provided in Section 6. number of statistically significant positive studies Total number of statistically and clinically significant positive studies High quality studies (Quality Score 8-16) Lower quality studies (Quality Score 0-7) No (%) SS* No ( %) not-SS* No (%) SS* No ( %) not-SS* *SS = Statistically Significant positive outcome Estimate of Clinical Impact Excellent Good Satisfactory Poor Clinical impact Meaningful health benefit very likely to achieved by consumers Meaningful health benefit likely to be achieved by consumers Impact on target population uncertain- health benefit possible. 6. BALANCE OF EVIDENCE (Section 3.2.1.9) Element Excellent Good Acceptable Unacceptable Consistency All high quality studies show SS positive effect Most high quality studies show SS positive effect High quality studies equivocal, lower quality studies mostly consistent Inconsistent (equivocal) or negative effect