Can we teach how to discriminate between good & bad evidence? the GATE approach
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1 Can we teach how to discriminate between good & bad evidence? in 20 minutes! the GATE approach Rod Jackson June 2010
2 GATE: a Graphic Appraisal Tool for Epidemiology A picture, 2 acronyms & 2 formulas
3 A picture: the GATE frame the shape of every epidemiological study
4 The ECT acronym: the 5 parts of every epidemiological study articipants Exposure Group E C Comparison Group Time T utcomes All epidemiological studies can be hung on the GATE frame
5 2 formulas: study analyses 1. ccurrence of disease = Numerator Denominator Time D N 2. Random error (95% Confidence Interval) = 1.96 x Standard Error
6 The RAMMbo* acronym: assessing study bias Recruitment E C E C Allocation Maintenance T T Measurement of outcomes blind or objective * aul Glasziou
7 GATE frame picture & ECT acronym articipants Exposure Group E C Comparison Group Time T utcomes Describe a study s design by hanging ECT on the frame
8 articipants Study Setting Eligible articipants articipants
9 Exposure & Comparison Groups Exposure or Intervention Group (EG) EG CG Comparison or Control Group (CG)
10 utcomes () Dis-ease yes no a c b d utcomes ()
11 Time (T) incidence T prevalence
12 Study design: GATE frame & ECT articipants Exposure Group E C Comparison Group utcomes Time T Every epidemiological study hangs on the GATE frame
13 HERS example JAMA 1998;280: articipants Study Setting: outpatients & community, 20 US centres Eligible articipants: post-menopausal women with CHD, < 80 years, with intact uterus articipants: 2763, mean age 66.7 years
14 Exposure & Comparison Groups Exposure or Intervention Group (EG): 0.625mg conj equine estrogen& 2.5mg progesterone in 1 tablet Comparison or Control Group (CG): placebo tablet of identical appearance
15 utcomes () Dis-ease : nonfatal MI or CHD death yes no a= 172 c b= 176 d utcomes ()
16 Time (T) utcome: non-fatal MI & CHD death T= 4.1 years (av. follow-up) incidence
17 Time (T) utcome: lipid levels T = at 1 year prevalence
18 2 formulas: study analyses 1. ccurrence of disease = Numerator Denominator Time D N 2. Random error (95% Confidence Interval) = 1.96 x Standard Error
19 All epidemiological studies involve measuring the CCURRENCE of disease ccurrence = Numerator Denominator D Denominator (articipants) = N D N Numerator (utcomes)
20 GATE study analyses verall Denominator Denominator 1: Denominator 2: Exposure EG CG Comparison Group Group (EG) (CG) Numerator 1: a a c b d Numerator 2: b Describe a study s analyses by hanging the numbers on the frame
21 ccurrence = N D Denominator 1: Exposure Group EG EG CG Denominator 2: Comparison Group CG Numerator 1: a a c b d Numerator 2: b Exposure Group ccurrence: EG = a EG Comparison Group ccurrence: CG = b CG
22 Calculate EG & CG for the outcome MI & CHD death in HERS Denominator 1: Exposure Group EG = 1380 EG CG Denominator 2: Comparison Group CG = 1383 Numerator 1: a = 172 a c b d Numerator 2: b = 176 EG = 172/1380 = 12.46/100 people in 5yrs CG = 176/1383 = 12.73/100 people in 5 yrs
23 Describing differences between occurrences Relative difference or Relative Risk = EG CG Absolute Difference or Risk Difference = EG - CG Number Needed To Treat (NNT) = 1 RD
24 Analyses it s all about EG & CG
25 The RAMMbo acronym: assessing study bias Recruitment E C E C Allocation Maintenance T T Measurement of outcomes blind or objective
26 E C RAMMbo appropriate Recruitment processes? Study setting & eligibility criteria well described? e.g. Recruit random/representative sample R consecutive eligiblesr volunteers from advertisements articipants representative of eligibles? rognostic/risk profile appropriate? T
27 RAMBbo: A is for Allocation RCT: Allocate randomly by investigators (e.g drugs) EG CG Cohort: Allocate by measurement (e.g. smoking) EG CG T T
28 T EG CG RAMMbo good Maintenance? did most participants remain in allocated groups (EG & CG) articipants &/or investigators blind to exposure (and comparison exposure)? Compliance high & similar in EG &CG? Contamination low & similar in EG &CG? Co-interventions low & similar in EG &CG? Completeness of follow-up high & similar in EG &CG?
29 A RAMMbo Measurement of outcomes blind orobjective? EG CG T If outcome measurements not bjective (eg. automated or definitive) were investigators blind to exposure (and comparison exposure)
30 The 4 (GATE) study biases Recruitment bias Allocation bias E C Maintenance bias T Measurement (of outcomes) bias
31 2 formulas: study analyses 1. ccurrence of disease = Numerator Denominator Time D N 2. Random error (95% Confidence Interval) = 1.96 x Standard Error
32 Excel CATs& paper Gate-lites There is a GATE for every study design
33 Including SRs & meta-analyses (the 3 rd acronym!) Find appropriate studies? Appraise selected studies? Include only valid studies? Total-up (synthesise) appropriately? Heterogeneity adequated addressed?
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