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gICAfn5+foCAgICAgICAfn6AgICAgIB+fn5+fn5+fn5+fn5+gICAgH5+foB+fn5+fn5+fn5+fn5+ gICAfn5+foCAfn5+fn5+fn5+fn5+fn6Afn5+foB+fn5+gIB+fn5+fn6AgICAfn6AgIB+fn6AgICA gICAgICAgICAgICAgICAgICAgICAgICAgICAgICAgICAgICAgICAgICAgAAAAA== ------=_NextPart_01C52EF7.F405D570 Content-Location: file:///C:/693ACE74/norman050322ppt_files/slide0020.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="us-ascii" RCT’s are the Gold Standard of Evidence
Randomized Controlled Trial= s
over the top (in cost), over the hill  and oversold
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Geoff Norman, Ph.D
McMaster University
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n I would like to thank Kelly Dore, Kevin Eva, and P.J. Devereaux = for their help in putting this together.
n
n
n
nThe opinions expresse= d are solely those of the author. No one else should be held accountable for what is to follow
------=_NextPart_01C52EF7.F405D570 Content-Location: file:///C:/693ACE74/norman050322ppt_files/slide0023.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="us-ascii" RCT’s are the Gold Standard of Evidence
Some Definitions
<= span class=3DBB style=3D'position:absolute;left:-4.36%;top:.3em'>nWhen I= say “Randomized Controlled Trial” I don’t mean:
<= span class=3DB3B style=3D'position:absolute;left:-3.7%;top:.3em'>nA litt= le tiny study with two or more groups
<= span class=3DB3B style=3D'position:absolute;left:-3.7%;top:.3em'>nWith a= couple of dozen participants
<= span class=3DB3B style=3D'position:absolute;left:-3.7%;top:.3em'>nWith an intervention that lasts hours or days
<= span class=3DB3B style=3D'position:absolute;left:-3.11%;top:.3em'>nWith a follow-up interval from 0 hours to a few weeks
<= span class=3DB3B style=3D'position:absolute;left:-3.7%;top:.3em'>nWith s= mall and cheap outcome measures
<= span class=3DB3B style=3D'position:absolute;left:-3.7%;top:.3em'>nWith a= total budget of a few  $,000 dollar= s
<= span class=3DB3B style=3D'position:absolute;left:-3.7%;top:.3em'>nWith a= sort-of randomization procedure
<= span class=3DB4B style=3D'position:absolute;left:-4.32%'>–(If it&#= 8217;s Tuesday, you’re in Group A)
------=_NextPart_01C52EF7.F405D570 Content-Location: file:///C:/693ACE74/norman050322ppt_files/slide0024.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="us-ascii" RCT’s are the Gold Standard of Evidence
I do mean:
nRANDOMIZED
nCONTROLLED
nTRIAL
------=_NextPart_01C52EF7.F405D570 Content-Location: file:///C:/693ACE74/norman050322ppt_files/slide0025.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="us-ascii" RCT’s are the Gold Standard of Evidence
What is an RCT?
nThousands of patients
nHundreds of centres
nDozens of investigators =
nMonths or years of interventions= 3;
nDecades of followup
nZillions of dollars
------=_NextPart_01C52EF7.F405D570 Content-Location: file:///C:/693ACE74/norman050322ppt_files/slide0001.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="us-ascii" RCT’s are the Gold Standard of Evidence
RCT’s are the Gold Standard
of Evidence
<= span style=3D'mso-special-format:bullet;color:yellow;mso-color-index:3;position= :absolute; left:-3.98%;top:.3em;font-family:Wingdings;font-size:75%'>n  For studies of therapy
n
<= span style=3D'mso-special-format:bullet;color:yellow;mso-color-index:3;position= :absolute; left:-3.98%;top:.3em;font-family:Wingdings;font-size:75%'>n  with drug interventions
n
<= span style=3D'mso-special-format:bullet;color:yellow;mso-color-index:3;position= :absolute; left:-3.98%;top:.3em;font-family:Wingdings;font-size:75%'>n  in cardiovascular research=
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Why only there?
nThere <= span style=3D'font-size:88%'>is an intervention
nThe intervention can be applied uniformly
nThe skill of the practitioner is not at issue =
nEffect Sizes are so small that bias is an <= /span>issue
nCondition is so common and serious, that
a)trial is feasible
b)cost is justifiable
------=_NextPart_01C52EF7.F405D570 Content-Location: file:///C:/693ACE74/norman050322ppt_files/slide0003.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="us-ascii" RCT’s are the Gold Standard of Evidence
1) There is an Intervention
nRisk factors:
–Contribution of driver, crash and vehicle <= /span>characteristics to mortality
nReliability /validity of Measures
–Validity of “transition” ratings =
nRetrospective analysis of data base
–Operative management of extremity fractures
nQualitative research of opinions
–Survey of surgeon opinion re Mx of tibial fracture= s
nEconomic analysis
n&= #13;
n
------=_NextPart_01C52EF7.F405D570 Content-Location: file:///C:/693ACE74/norman050322ppt_files/slide0004.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="us-ascii" RCT’s are the Gold Standard of Evidence
There is an Intervention
n
nObservation of spectral lines of hydrogen
–Quantum mechanics, modern chemistry & physics&= #13;
– (one group, post-test design; case series) <= /b>
n<= b>
nAdvance of perihelion of Mercury orbit =
–General relativity, cosmology
– ( single observ= ation; case report)
–
nObservation of decay products from U23= 5 fiss= ion
–A-bomb, nuclear power
– ( single observ= ation; case report)
n&= #13;
n&= #13;
n
------=_NextPart_01C52EF7.F405D570 Content-Location: file:///C:/693ACE74/norman050322ppt_files/slide0009.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="us-ascii" RCT’s are the Gold Standard of Evidence
Proportion of Experiments, RCTs
in NEJM, Lancet, Science, Natur= e
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2)The Intervention can be Applied Uniformly
nMany non-drug interventions have multiple components, many subtle differences in application.
nLarge scale trials are unlikely to lead to interpretable results = ;
&= #8211;E.g  PBL vs. Conventional  Instruction
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PBl vs Other on Knowledge Test
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6ZzeeZ3YaZLWOZu+yQjiiZrnGZ3TqJ7t6Z7vCZ/xKZ/zSZ/1aZ/3/omf+amf+8mf/emf/wmgASqg A0qgBWqgB4qgCaqgC8qgDeqgDwqhESqhE0qhFWqhF4qhGaqhG8qhHeqhH5qgMlZBnIieH5gojyGi 4oQbKTqiJzoW5kCiPPQqMQqBNMo3ldCGWnKiNsoxz8Kj2bmJ3vCjIoiiiCGH2LCizrUYybWjMNpZ RYqjojUOJ6JfVnKkBDGE/TCkPUpTW1qTUtoOVLqi/pKjURoOXipXtoamUVCmU0po9NGm4kSSXKpL CoEfNBFISPpaSAqmWNpWMhOndiqbT6Oja8qmLEplZmqobAqji6o6otV1cICokgoLk7pElgpIRoqp m1ikkXqPMFAAADs= ------=_NextPart_01C52EF7.F405D570 Content-Location: file:///C:/693ACE74/norman050322ppt_files/slide0007.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="us-ascii" RCT’s are the Gold Standard of Evidence
3) Practitioner skill is not at issue
n<= span style=3D'font-size:88%'>If outcome is influenced by practitioner (surgeon, teacher) skill, then must locate = interventions where:
a)Clinicians are equally skilled at both or
b)Patients are randomized to (clinician + procedure)
n
n If  trial is of a new procedure, then= comparison is between:
n novices with new procedure
n        = ;            &n= bsp;            = ;         vs.
n experts with old procedure
n
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Is practitioner skill an issue?
n<= span style=3D'font-size:88%'>Education
–<= /span>Teacher effects 3x variance of curriculum effects&= #13;
n<= span style=3D'font-size:88%'>Surgery
–<= /span>Colorectal Cancer
»<= /span>Recurrence rate 1.4 x for <21 resections/year&#= 13;
–<= /span>Abdominal aneurism
»<= /span>Operative failure rate decreases up to 55/year = ;
–<= /span>Pancreatic cancer resection
»<= /span>Mortality rate:
n< 5 cases,&nbs= p; 19%
n 5-50 cases  7% <= /div>
n>50 cases 1%
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Why are we so obsessed wi= th randomization anyway?
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Does study design  bias results?
(Do observational studies misl= ead us into thinking result= s are beneficial when they’re not?)
nAnecdotal:
–G= astric freezing and ulcer
–<= span style=3D'mso-spacerun:yes'> clofibrate and hypercholesterolemi= a
–I= nternal mammary artery ligation and angina
R= 11;(Sackett, Haynes, Tugwell, 1985)
R= 11;
R= 11;
nBut study conclusions may disagree; that’s why we do meta-analysis
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Does study design bias results?
Medicine
nMaybe:
n(Ionnidis et al., 2001)45 topics, 240 RCT/168 Obs studies
n -Results differed beyond chance 16%
n OBS>RCT =3D28;   RCT>OBS =3D11
n=
nMaybe not:
n(Concato, 2000)5 topics, 99 articles
n “results of  Obs studies do not systematically overestimate the magni= tude of effects of treatment..”
n(Benson, 2000) 19 topics, 136 reports
n  “in only 2 of the 19 did the combined effect of= Obs lie outside 95%CI for RCT”        = ;    
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Does study design (RCT vs observational) bias results?
Education/Ps= ychology
n
nNo:(Lipsey&Wilson, 1993)=
n= 319 meta-analyses, 14,000 studies
n= <= /span>ES
n Mean SD
nRandomized .46 .28
n= Observational .41 .36
n
nHigh quality .40 <= /span>.27
n= Low quality .37 .29
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Why the difference?
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4) Effect Sizes of Clinical Interventions are so Small that Bias is an Issue 
n<= span style=3D'font-size:88%;color:#FF33CC;mso-color-index:5'>Effect size for cl= inical therapies (Meyer, 2001)
–Aspirin and risk of MI 0.02
–Antihypertensive and risk of stroke 0.03
–Chemo and breast Ca mortality 0.03
–CABG and 5 yr. Survival 0.08
–
nEffect size for educational/psychological interventions (Lipsey & Wilson, 1993)
–301 meta-analyses, 14,000 studies
– Mean ES =3D 0.45
n
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Differential Publication Bias?
nLipsey & Wilson  (1993); Begg & Berlin (1988)&= #13;
n
nPublication Bias <= /b>- Studies with positive results are more likely to= be published than studies with negative results= 3;
n=
n       Probability
n Submitted Accepted TOTAL
nPOSITIVE .82       .80 .66
n
n= NEGATIVE .43       .50 .22
n=
n Mean ES= PUBLISHED .53
n UNPUBLISHED .39
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Differential publication bi= as in clinical studies?
nIt seems likely , but unproven, that negative RCT’s have a greater chance of publication than negative observational studies
–L= arger samples
–<= span style=3D'mso-spacerun:yes'> The “Right” answer = ;
–L= ess bias
–
nThis would explain why RCTs show smaller = effects in health
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5) Society will tolerate the cost 
nCost of RCTs and oth= er research (Detsky, 1989)
n N/group<= span style=3D'mso-tab-count:1;width:5.07%'> Cost
nRCT
nLRC-CPPT = 2000 $150,000,000
nMRFIT 640= 0 $110,000,000
nCAPRIE 95= 00 $300,000,000
nVIGOR 400= 0 $100,000,000
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Society will tolerate the cost 
n<= span style=3D'font-size:75%'>Cost of RCTs and other research =
n N/group <= /span>Cost
nRCT
nLRC-CPPT 2000 = $150,000,000
nMRFIT 6400 = $110,000,000
nCAPRIE 9500 = $300,000,000
nVIGOR 4000 = $100,000,000
n
nCIHR Budget fy 2001 $402,000,000
nMed Educ (Cdn) fy 2002        $20= 0,000
n
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Society will tolerate the cost 
n
n N/group    Relative Risk Endpoint               Reduction
nRCT
nLRC-CPPT 2000 .19 *= Cardiac Death . 07 ns Overall =
nMRFIT 6400 .07 ns Cardiac Death
nCAPRIE 9500 .19 * AMI
nVIGOR 4000 .50*(.34) GI event
n 4.0* AMI
nWOSCOP 3300 .31 AMI,CHD
nCNBSS 10000 .15* Breast Ca death <= /div>
n
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Society will tolerate the cost 
n N/group Risk ARR     Lives Reduction Saved
nRCT
nLRC-CPPT 2000 .19 * =      0.04% 3
nMRFIT 6400 .07 ns=      0.14% -5
nCAPRIE 9500 .19 * =       0.51% +11
nVIGOR 4000 .34/4.00  -0.3% -12
nCNBSS 20000 .15      0.04% -2
nWOSCOP 3200 .31      2.40% 29
nEducation
nBCIC 10600 .19 * =      0.9% 75
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&nb= sp;
n
n
<= span class=3DB1B style=3D'position:absolute;left:-4.23%'>–Outcome = is serious (death)
  <= /div>
<= span class=3DB1B style=3D'position:absolute;left:-4.0%'>– Prevalence is high (it could happe= n to me!)
Why do we tolerate the cost?
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Cost & No.at Risk/yr (Detsky, 1= 989)
MRFIT
LRC-CPPT
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Does this translate into practice?
nEvidence – Based Medicine
&= #8211; Individual Practitioner
&= raquo;Identifies a clinical problem
&= raquo;Initiates search of the literature
&= raquo;Critically appraises retrieved articles
&= raquo;Changes approach to practice
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>> Identifies a problem
nReflective Practice
&= #8211;Problems arise when
&= raquo;things don’t fit
&= raquo;patient doesn’t respond
&= raquo; co-morbidity present, etc.
nAdvances in research arise from:
&= #8211; common conditions with:
&= raquo;no comorbidity
&= raquo;risk of event is high =
&= raquo;Rx is directed at risk reduction
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nThe places where the advances occur are precisely the places where the MD is least likely to notice a problem <= /div>
n
nThe consequences of adopting the advance are invisible:
= 211;The doc never sees the MI (stroke, death, etc.) she prevented
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>> Initiates literature search=
&= #8211;McKibbon & Haynes
n
n  Overlap between Librarian and cli= nician search:
n All articles -  12%
n Critical articles - 14%
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>> Critically appraises article=
n
n Norman GR, Shannon SI.. CMAJ 1998; 158: = 177-181.
n
n Green ML. Acad Med 1999; 74: 686-694
n
n Coomarasamy A, Khan KS. BMJ 2004; 329: 1017-1021
n
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n<= span style=3D'font-size:88%'>Gehlbach, 1980 Exp Cont
–<= /span>23R2/3 / 12R1&nbs= p; 15h MCQ 74% 64%
n&= #13;
n<= span style=3D'font-size:88%'>Linzer, 1987
–<= /span>42/43 R2/3 52h MCQ 61% 62%
n&= #13;
n<= span style=3D'font-size:88%'>Linzer, 1988
–<= /span>22/19 R1 52h MCQ K +10%+2%
n&= #13;
n<= span style=3D'font-size:88%'>Kitchens, 1989
–<= /span>41/29 17/13h MCQ   66%   63%
–        = ;            &n= bsp;            = ;      Skills    +3 =   +10
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–= 3;
n<= span style=3D'font-size:88%'>Langkamp, 1992        = ;          Exp Cont   
–<= /span>14/13= 10h     MCQ 55% 49%
n&= #13;
n<= span style=3D'font-size:88%'>Green, 1997
–19/15= 7h Cases 65% 42% *
n&= #13;
n<= span style=3D'font-size:88%'>Smith, 2000
–<= /span> 18/3= 7 14x2h  Total 64% 45%    <= /span> CA 44%   38%
n&= #13;
n<= span style=3D'font-size:88%'>Goldszmidt, 2002
–<= /span>22 / 0 8h MCQ 48% 54%
–        = ;            &n= bsp;            = ;  
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Change in Knowledge (Residents)
<= ![endif]>
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Reading Habits
n<= span style=3D'font-size:75%'>Linzer, 1987
–<= /span>No  c= hange in articles read
n<= span style=3D'font-size:75%'>Linzer, 1988
–<= /span>Exp residents read less after
n<= span style=3D'font-size:75%'>Green, 1997
–<= /span> No c= hange in articles read
n<= span style=3D'font-size:75%'>Seelig, 1991
–<= /span>No change in hours reading
n<= span style=3D'font-size:75%'>Smith 2001
–<= /span>> 3 Lit searches/wk 59% vs.16%