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Strategies for data analysis: RCTs

Gilda Piag= gio
UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in
 Human Reproduction
World Health Organization
Geneva, 24 February 2006
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UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
 = Design depending = on method of randomisation:
• Completely randomised
• Paired-matched
• Stratified
• Cross-over
 = Design depending = on unit of randomisation:
• Individually randomised
• Cluster randomised
 For experimental studies:
The strategy for data analysis depends on the study design
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UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
Strategies for data analysis: RCTs
 
• Trial profile: analysis by ITT or per protocol?
• Baseline characteristics by treatment groups
• Crude effect of treatment
• Effect of treatment adjusting for possi= ble confounders
• Effect modifiers and stratified analyse= s
• Other analyses: secondary, sensitivity, subgroup
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Intention-to-treat principle:
All patients are included in the analysis= in the group to which they were randomised, even if they did not receiv= e the allocated treatment
Per protocol analysis:
Randomised subjects who are non-eligible are excluded
Trial profile: analysis by ITT or per protocol?
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HRP<= /span>
Reasons subjects were excluded from trials in the past:
• Non-eligibility
• Non-compliance
• Had other illnesses =
• Did not attend all visits
• Moved out
• Dropped out
Trial profile: analysis by ITT or per protocol?
Lost to follow-up= or withdrawn<= /span>
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‘...all eligible patients, regardless of compliance with protocol should be included in the analysis of results whenever possible’
‘The alternative ‘explanatory approach’ or ‘analysis of compliers only’ c= an distort treatment comparisons’
Po= cock, 1983
Trial profile: analysis by ITT or per protocol?
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UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
 Advantages of ITT:
• inclusion of all randomised subjects gu= ards against any bias incurred by subjective choice of ineligible subjects
• inclusion better if the trial’s finding= s are to be extrapolated to future clinical practice in which eligibility for a given treatment is less-strictly defined
Trial profile: analysis by ITT or per protocol?
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UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
 Intention to t= reat is not possible or can be relaxed:
• when outcome is not known (for example,= in withdrawals)
• when a subject withdraws before treatme= nt starts (caution: check if numbers and reasons are similar between groups)
• in Phase I and Phase II clinical trials, which explore properties of treatment in idealized conditions
• when eligibility criteria are clear and objective and when the trial is double-blind
Trial profile: analysis by ITT or per protocol?
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UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
Trial profile: analysis by ITT or per protocol?
 Construct a flow = chart providing numbers of subjects:
• registered or eligible
• randomised
• assigned to each group
• withdrawn (lost to follow-up and other reasons)
• completing the trial (with outcome known)
• not receiving/complying with treatment = as allocated
by = group
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HRP<= /span>
Objectives:
• Confirm that two doses of 0.75mg of levonorgestrel given 12 hours apart for emergency contraception have&#= 13;
• the same effectiveness but =
• fewer side effects than the Yuzpe regimen
• Assess regimens effectiveness if the de= lay between intercourse and the start of the treatment is extended = (from 48 hours) t= o 72 hours.

(Ref: Task = Force on Postovulatory Methods of Fertility Regulation, Lancet 1998)
The Yuzpe-levonorgestrel trial =
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UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
Design:
• Randomised contro= lled trial
• Double-blind
• Multicenter (21 centres in 14 countries= ): stratified
• Equivalence trial
The Yuzpe-levonorgestrel trial =
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UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
The Yuzpe-levonorgestrel trial =
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5DSsDqDxcvWbuBi5bVg5DSunYeU0rJyGldOwchpWTsPKaVhdLo2vznDNy6VxDjkNK6dh5TSsnIaV 07ByGlZnoRHPcdFD5LZh5TSsnIaV07ByGlZOw8ppWDkNK6dh5TSs7qRxpJQI15JZYas1bcNpXLec hpXTsHIaVk7DymlYOQ0rp2HlNKychpXTsHIaVk7DymlYOQ0rp2F1RTS+Wf8SV0TjBHIaVk7DymlY OQ2rC6axUi3H1+mCaZxBTsPKaVg5DSunYeU0rK6dxnGrb1w7jePKaVg5Datrp3Hc8P3aaTys8uk+ XTuN4+rqadTH/LCrp3FUOQ0rp2HlNKychpXTsHIaVk7DymlYOQ0rp2HlNKychpXTsHIaVhdN46tT X/Ciabw89QWdhtX/AVAnI9BI11+RAAAAAElFTkSuQmCC ------=_NextPart_01C63AC1.F1FE6CC0 Content-Location: file:///C:/2409C636/RCTs_Analysis_Piaggio_2006_files/slide0117.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Strategies for data analysis: RCTs - Gilda Piaggio
UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
Strategies for data analysis: RCTs
 
• Trial profile: analysis by ITT or per protocol?
• Baseline characteristics by treatment groups
• Crude effect of treatment
• Effect of treatment adjusting for possi= ble confounders
• Effect modifiers and stratified analyse= s
• Other analyses: secondary, sensitivity, subgroup
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UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
Baseline characteristics by treatment groups
 Comparison is made by assessing the prognostic relevance of the difference observed, not using test= s of hypothesis:
• Compute sample statistics (means and st= andard deviations or medians and quartiles or percentages) by treatment g= roup
• Compare baseline characteristics between treatment groups to discover possible confounders: randomisation will produce very similar baseline statistics if the sample size is large
------=_NextPart_01C63AC1.F1FE6CC0 Content-Location: file:///C:/2409C636/RCTs_Analysis_Piaggio_2006_files/slide0067.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Strategies for data analysis: RCTs - Gilda Piaggio
UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
       Yuzpe        LNG = ;
     (n=3D979)      (n=3D976= )
 
Variable Mean SD Mean SD
Age (years)<= span style=3D'mso-tab-count:4;width:36.23%'> 27.2 6.8 27.3 7.0
Weight (kg)<= span style=3D'mso-tab-count:4;width:36.08%'> 58.6 9.6 58.4      10.4
Height (cm)<= span style=3D'mso-tab-count:2;width:16.18%'>              162.8 6.5        162.9 6.4
BMI (kg/m2) 22.1 3.3 22.0 3.6
Cycle length (days) 28.8 2.5 28.9 2.4
Interval from estimated ovulation -1= .0 5.2 -0.9 5.0
  to intercourse (days)
Treatment group
The Yuzpe-levonorgestrel trial
 Characteristics of subjects
------=_NextPart_01C63AC1.F1FE6CC0 Content-Location: file:///C:/2409C636/RCTs_Analysis_Piaggio_2006_files/slide0118.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Strategies for data analysis: RCTs - Gilda Piaggio
UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
Strategies for data analysis: RCTs
 
• Trial profile: analysis by ITT or per protocol?
• Baseline characteristics by treatment groups
• Crude effect of treatment
• Effect of treatment adjusting for possi= ble confounders
• Effect modifiers and stratified analyse= s
• Other analyses: secondary, sensitivity, subgroup
------=_NextPart_01C63AC1.F1FE6CC0 Content-Location: file:///C:/2409C636/RCTs_Analysis_Piaggio_2006_files/slide0022.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Strategies for data analysis: RCTs - Gilda Piaggio
UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
Crude effect of treatment
• Estimate the magnitude of the effect on= the outcome measure and compute a confidence interval
• A p-value can also be provided
------=_NextPart_01C63AC1.F1FE6CC0 Content-Location: file:///C:/2409C636/RCTs_Analysis_Piaggio_2006_files/slide0068.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Strategies for data analysis: RCTs - Gilda Piaggio
UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
Group    Number of     Observed<= span style=3D'mso-tab-count:1;width:1.6%'>     Pregnancy =
  women   pregnancies      rate (%) 95% CI
Yuzpe    979     31    3.2       (2.2 to 4.5)           LNG    976   11    1.1       (0.6 to 2.0)
Relative ris= k (RR) of pregnancy for LNG compared with Yuzpe:
RR      95% C= I
      0.36 (0.18 to 0.70)
*
The Yuzpe-levonorgestrel trial
 Pregnancy rates
------=_NextPart_01C63AC1.F1FE6CC0 Content-Location: file:///C:/2409C636/RCTs_Analysis_Piaggio_2006_files/slide0047.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Strategies for data analysis: RCTs - Gilda Piaggio
UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
<= span style=3D'mso-tab-count:2;width:28.92%'> Yuzpe LN= G &#= 13;
Side effect <= b> No. of Rate No. of Rate p-value
Cases (%) <= /span>Cases (%) <= span style=3D'mso-tab-count:2;width:14.73%'>
<= span style=3D'mso-tab-count:1;width:23.98%'>
Nausea 494 50.5 226 23.1 <0.01
Vomiting 184 18.8     55   5.6 <0.01
Headache 198 20.2 164 16.8   0.06   
Dizziness 163 16.7 109 11.2 <0.01
Fatigue 279 28.5 165 16.9 <0.01
The Yuzpe-levonorgestrel trial
 Incidence of side effects
------=_NextPart_01C63AC1.F1FE6CC0 Content-Location: file:///C:/2409C636/RCTs_Analysis_Piaggio_2006_files/slide0119.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Strategies for data analysis: RCTs - Gilda Piaggio
UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
Strategies for data analysis: RCTs
 
• Trial profile: analysis by ITT or per protocol?
• Baseline characteristics by treatment groups
• Crude effect of treatment
• Effect of treatment adjusting for possi= ble confounders
• Effect modifiers and stratified analyse= s
• Other analyses: secondary, sensitivity, subgroup
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UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
 Group No. of   = <= b>     No. of pregnancies                Efficacy**       women   Observed<= span style=3D'mso-spacerun:yes'>  Expected*   (%) 95% CI
Yuzpe       979 31    74.2    58 (41, 72)
LNG       976 11    76.3    86 (74, 93)
* Using Dixon’s estimates of conception probabilities
** Prevented fr= action
Ratio of standardised pregnancy rates of LNG with respect to Yuzpe: =
Ratio     95% CI&= #13;
      0.34 (0.16, 0.70)
 
*
The Yuzpe-levonorgestrel trial
 Efficacy: prevented fraction
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UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
<= span style=3D'font-size:89%'>Effect of treatment adjusted for possible <= /span>confounders
• Determine possible confounders:
• Variables with imbalance between groups=
• Variables related to outcome: examine association between different variables and the outcome
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UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
<= span style=3D'font-size:89%'>Effect of treatment adjusted for possible <= /span>confounders
•  Adjust for confounders:
• Include confounders in a multivariate model
• Account for collinearity between variab= les in the model
• Confounding is not as important as in observational studies because randomisation will produce balance between treatment groups<= /span>
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UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
Strategies for data analysis: RCTs
 
• Trial profile: analysis by ITT or per protocol?
• Baseline characteristics by treatment groups
• Crude effect of treatment
• Effect of treatment adjusting for possi= ble confounders
• Effect modifiers and stratified analyse= s
• Other analyses: secondary, sensitivity, subgroup
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UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
Effect modifiers and stratified analysis
 
• Stratify by centre
• Test homogeneity of effect across centr= es (interaction of treatment by centre)
• If there is homogeneity between centres= , pool the effect over centres (adjust effect for centres)
• Consider other effect modifiers<= /span>
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UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
Chi-square for trends: p=3D0.018=
The Yuzpe-levonorgestrel trial
 Efficacy of Yuzpe by treatment delay
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UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
Strategies for data analysis: RCTs
 
• Trial profile: analysis by ITT or per protocol?
• Baseline characteristics by treatment groups
• Crude effect of treatment
• Effect of treatment adjusting for possi= ble confounders
• Effect modifiers and stratified analyse= s
• Other analyses: secondary, sensitivity, subgroup
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UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
Population    No. of     No. of
     women   pregnancies=       RR    95% CI
Efficacy ITT=   1955     42    0.36       (0.18, 0.70)
Eligible   1855 31 0.34 (0.15, 0.76)
Perfect use<= span style=3D'mso-tab-count:1;width:.03%'>   1157     16 0.46 (0.16, 1.32) =
*
The Yuzpe-levonorgestrel trial
 ITT analysis and secondary analyses
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UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
Interp= retation
• State findings clearly
• Discuss internal validity: sources of b= ias and imprecision
• Discuss external validity=
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UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
0-12
13-24
25-36
37-48
49-60
61-72
3D"Text
Pregnancy ra= te (%)
=       Delay (hours)
(n=3D386)=           (n=3D522        (n=3D326)       (n=3D379)          (n=3D191)          (n=3D146)
0.5
1.5
1.8
2.6
3.1
4.1
The Yuzpe-levonorgestrel trial
 Effect of delay on pregnancy rates
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UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
Presen= tation
• Describe protocol deviations from the s= tudy as planned, together with the reasons (for ineligibility, non-compliance, withdrawal)
• Percentages: state results in absolute numbers (10/20, not only 50%)
• Present statistics in sufficient detail= to permit alternative analyses and replication
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UNDP  /  UNFPA  /  WHO  /  WORLD BANK
HRP<= /span>
• The LNG regimen i= s more effective than the Yuzpe regimen.
• = It is better tolerated.
• With both regimens, earlier treatment i= s more effective.
 
The Yuzpe-levonorgestrel trial
 Conclusions
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<= /div>
<= /div>
<= /div>
Page ‹#›
Body Text
Second Level
Third Level
Fourth Level
Fifth Level
SLIDE LIBRARY&= #13;
Document name: PVLAUS95.PPT
Filed on diskette: PVL1
Printout filed under: = PVL presentations
Author: Paul V= an Look, HRP
Slides created by: Teresa Harmand, HRP
Date: October 1995
Software: Powe= rpoint 4.0
Description:
Slides prepared for Paul Van Look ‘s presentation in Melbourne, No= vember 1995.  “Emergency Contraception....”  61 slides. 
<= span lang=3DEN-US style=3D'mso-special-format:lastCR'>
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<= span lang=3DEN-US style=3D'mso-special-format:lastCR'>
<= span lang=3DEN-US style=3D'mso-special-format:lastCR'>
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SupportsPPTAnimation() { return( navigator.platform =3D=3D "Win32"= && navigator.appVersion.indexOf("Windows")>0 ) } function SupportsPPTHTML() { var appVer=3Dnavigator.appVersion, msie=3DappVer.indexOf("MSIE "), ver=3D0 if( msie >=3D 0 ) ver=3DparseFloat( appVer.substring( msie+5, appVer.indexOf(";",msie) ) ) else ver=3DparseInt(appVer) return( ver >=3D 4 && msie >=3D 0 ) } function _RSW() { if( !g_supportsPPTHTML || IsNts() || ( !g_scaleInFrame && (!IsWin("PPTSld") || !parent.IsFullScrMode()) ) ) return var padding=3D0; if( IsWin("PPTSld") && parent.IsFramesMode() ) padding=3D6 cltWidth=3Ddocument.body.clientWidth-padding cltHeight=3Ddocument.body.clientHeight-padding factor=3D(1.0*cltWidth)/g_origW if( cltHeight < g_origH*factor ) factor=3D(1.0*cltHeight)/g_origH newSize =3D g_origSz * factor if( newSize < 1 ) newSize=3D1 s=3DSlideObj.style s.fontSize=3DnewSize+"px" s.posWidth=3Dg_origW*factor s.posHeight=3Dg_origH*factor s.posLeft=3D(cltWidth-s.posWidth+padding)/2 s.posTop=3D(cltHeight-s.posHeight+padding)/2 if( g_scaleHyperlinks ) ScaleHyperlinks( factor ) } function _InitAnimations() { animRuntimeInstalled =3D ''+document.body.localTime !=3D 'undefined'; isFullScreen =3D (window.name =3D=3D "PPTSld") && !parent.IsFramesMode(); g_animUseRuntime =3D g_showAnimation && animRuntimeInstalled && !(isFullSc= reen && parent.IsSldVisited()); if( g_animUseRuntime ) { collSeq =3D document.all.tags("seq"); if( collSeq !=3D null ) { for(ii=3D0;ii numSlds ) gSldJumpIdx =3D numSlds; if ( gSldJumpIdx >=3D 0 ) { if ( gSldJumpIdx =3D=3D 0 ) gSldJumpIdx =3D 1; var jumpTo =3D parseInt(gSldJumpIdx); gSldJump =3D 0; gSldJumpIdx =3D ""; win.GoToSld( parent.GetSldList().mList[jumpTo-1].mSldHref ) } } } function _KDH() { if( event.keyCode =3D=3D 8 ) { event.returnValue =3D 0; parent.GoToPrevSld(); } } function DocumentOnClick() { if( IsNts() || parent.HideMenu() ) return; if( ( g_allowAdvOnClick && !parent.IsFramesMode() ) || (event && (event.keyCode=3D=3D32) ) ) parent.GoToNextSld(); } var g_supportsPPTHTML =3D SupportsPPTHTML(), g_scaleInFrame =3D 1, gId=3D""= , g_bgSound=3D"", g_scaleHyperlinks =3D false, g_allowAdvOnClick =3D 1, g_showInBrowser = =3D 0, gLoopCont =3D 0, gUseSldTimings =3D 0; var g_showAnimation =3D g_supportsPPTHTML && SupportsPPTAnimation() && ( (w= indow.name=3D=3D"PPTSld" && !parent.IsFramesMode()) || g_showInBrowser );va= r g_animManager =3D null; var g_animUseRuntime =3D false; var g_animItemsToHide, g_animInteractiveItems, g_animSlideTime; var g_animMainSequence =3D null; var ENDSHOW_MESG=3D"End of slide show, click to exit.", SCREEN_MODE=3D"Fram= es", gIsEndShow=3D0, NUM_VIS_SLDS=3D30, SCRIPT_HREF=3D"script.js", FULLSCR_= HREF=3D"fullscreen.htm"; var gCurSld =3D gPrevSld =3D 1, g_offset =3D 0, gNtsOpen =3D gHasNts =3D gO= tlTxtExp =3D 0, gHasNarration =3D 0, gOtlOpen =3D true window.gPPTHTML=3DSupportsPPTHTML() var gMainDoc=3Dnew Array(new hrefList("slide0018.htm",1,-1,1),new hrefList(= "slide0017.htm",1,-1,1),new hrefList("slide0019.htm",1,-1,1),new hrefList("= slide0075.htm",1,-1,1),new hrefList("slide0076.htm",1,-1,1),new hrefList("s= lide0033.htm",1,-1,1),new hrefList("slide0032.htm",1,-1,1),new hrefList("sl= ide0034.htm",1,-1,1),new hrefList("slide0020.htm",1,-1,1),new hrefList("sli= de0065.htm",1,-1,1),new hrefList("slide0066.htm",1,-1,1),new hrefList("slid= e0073.htm",1,-1,1),new hrefList("slide0117.htm",1,-1,1),new hrefList("slide= 0021.htm",1,-1,1),new hrefList("slide0067.htm",1,-1,1),new hrefList("slide0= 118.htm",1,-1,1),new hrefList("slide0022.htm",1,-1,1),new hrefList("slide00= 68.htm",1,-1,1),new hrefList("slide0047.htm",1,-1,1),new hrefList("slide011= 9.htm",1,-1,1),new hrefList("slide0069.htm",1,-1,1),new hrefList("slide0025= .htm",1,-1,1),new hrefList("slide0077.htm",1,-1,1),new hrefList("slide0120.= htm",1,-1,1),new hrefList("slide0035.htm",1,-1,1),new hrefList("slide0078.h= tm",0,-1,1),new hrefList("slide0121.htm",1,-1,1),new hrefList("slide0042.ht= m",0,-1,1),new hrefList("slide0030.htm",1,-1,1),new hrefList("slide0046.htm= ",1,-1,1),new hrefList("slide0026.htm",1,-1,1),new hrefList("slide0070.htm"= ,1,-1,1)); /********************************************* Frameset functions These functions control slide navigation and state of the frameset. **********************************************/ function FullScrInit() { g_allowAdvOnClick =3D GetCurSld().mAdvOnClk document.body.style.backgroundColor=3D"black" document.oncontextmenu=3Dparent._CM; document.onkeydown =3D _KDH; document.ondragstart=3DCancel document.onselectstart=3DCancel self.focus() } function Redirect( frmId ) {=09 var str=3Ddocument.location.hash,idx=3Dstr.indexOf('#'), sId=3DGetSldId() if(idx>=3D0) str=3Dstr.substr(1); if( window.name !=3D frmId && ( sId !=3D str) ) { obj =3D GetObj("Main-File") window.location.href=3Dobj.href+"#"+sId return 1 } return 0 } var MHTMLPrefix =3D CalculateMHTMLPrefix();=20 function CalculateMHTMLPrefix() { if ( document.location.protocol =3D=3D 'mhtml:') {=20 href=3Dnew String(document.location.href)=20 Start=3Dhref.indexOf('!')+1=20 End=3Dhref.lastIndexOf('/')+1=20 if (End < Start)=20 return href.substring(0, Start)=20 else=20 return href.substring(0, End)=20 } return ''; } function GetTags(base,tag) { if(g_supportsPPTHTML) return base.all.tags(tag); else return base.getElementsByTagName(tag); } function UpdNtsPane(){ if(frames["PPTNts"]) PPTNts.location.replace( MHTMLP= refix+GetHrefObj( gCurSld ).mNtsHref ) } function UpdNavPane( sldIndex ){ if(gNavLoaded) PPTNav.UpdNav() } function UpdOtNavPane(){ if(gOtlNavLoaded) PPTOtlNav.UpdOtlNav() } function UpdOtlPane(){ if(gOtlLoaded) PPTOtl.UpdOtl() } function SetHasNts( fVal ) { if( gHasNts !=3D fVal ) { gHasNts=3DfVal UpdNavPane() } } function ToggleOtlText() { gOtlTxtExp=3D!gOtlTxtExp UpdOtlPane() } function ClearMedia() { // Clear any sounds playing before launching another browser window. Other= wise, // in fullscreen mode, you'll continue to hear the sound in the frames mod= e. if (PPTSld.pptSound) PPTSld.pptSound.loop =3D 0; } function FullScreen() {=20 if ( PPTSld.g_animUseRuntime ) PPTSld.document.body.pause(); ClearMedia(); var href =3D ( document.location.protocol =3D=3D 'mhtml:') ? FULLSCR_HREF = : FULLSCR_HREF+"#"+GetHrefObj(gCurSld).mSldHref; if(PPTNav.event.ctrlKey) { var w =3D (window.screen.availWidth * 1.0) / 2.0 var h =3D w * (PPTSld.g_origH * 1.0) / PPTSld.g_origW win =3D window.open( MHTMLPrefix+href,null,"toolbar=3D0,resizable=3D1,top= =3D0,left=3D0," + "width=3D"+ w + ",height=3D" + h ); if( win.document.body && PPTSld.g_animUseRuntime ) win.document.body.PPTSldFrameset=3Dwindow; } else { win =3D window.open( MHTMLPrefix+href,null,"fullscreen=3Dyes" ); if( win.document.body && PPTSld.g_animUseRuntime ) win.document.body.PPTSldFrameset=3Dwindow; } } function ToggleVNarration() { rObj=3DPPTSld.document.all("NSPlay") if( rObj && !PPTSld.g_animUseRuntime ) { if( (rObj.playState =3D=3D 1)||(rObj.playState =3D=3D 0) ) rObj.Play() else if( rObj.playState =3D=3D 2 ) rObj.Pause() else return; } else if( PPTSld.g_animUseRuntime ) { narObj =3D PPTSld.document.all("narrationID") if( narObj ) narObj.togglePause() } } function GetCurSldNum() { =20 obj=3DGetHrefObj(gCurSld) if( obj.mOrigVis =3D=3D 1 ) return obj.mSldIdx else =20 return gCurSld } function GetNumSlds() { =20 if( GetHrefObj(gCurSld).mOrigVis =3D=3D 1 ) return GetSldList().mNumVisSlds; else return GetSldList().mList.length } function GetSldNum( href ) { for(ii=3D0; ii 1 ) PopSldList(); else if( !IsFramesMode() ) { if( gLoopCont ) GoToFirst() else EndShow() } } function GoToPrevSld() { ii=3DgCurSld-1 if( ii > 0 ) { obj=3DGetHrefObj(ii) while ( obj && ( obj.mVis =3D=3D 0 ) && ( ii>0 ) ) obj=3DGetHrefObj(--ii) if( ii =3D=3D 0 ) ii=3D1 GoToSldNum(ii) } } function GoToFirst(){ GoToSld( GetHrefObj(1).mSldHref ) } function GoToLast() { ii=3DGetSldList().mList.length if( ii !=3D gCurSld ) GoToSld( GetHrefObj(ii).mSldHref ) } function GoToSldNum( num ) { if( PPTSld.event ) PPTSld.event.cancelBubble=3Dtrue obj =3D GetHrefObj( num ) obj.mVis=3D1 gPrevSld=3DgCurSld gCurSld =3D num; PPTSld.location.replace(MHTMLPrefix+obj.mSldHref) if( IsFramesMode() ) { UpdNavPane(); UpdOtlPane(); UpdNtsPane() } } function GoToSld( href ) { if( PPTSld.event ) PPTSld.event.cancelBubble=3Dtrue GetHrefObj( GetSldNum(href) ).mVis=3D1 PPTSld.location.replace(MHTMLPrefix+href) } function SldUpdated( id ) { if( id =3D=3D GetHrefObj(gCurSld).mSldHref ) return gPrevSld=3DgCurSld gCurSld=3DGetSldNum(id) if( IsFramesMode() ) { UpdNavPane(); UpdOtlPane(); UpdNtsPane() } } function PrevSldViewed(){ GoToSld( GetHrefObj(gPrevSld).mSldHref ) } function HasPrevSld() { return ( gIsEndShow || ( gCurSld !=3D 1 && GetHrefO= bj( gCurSld-1 ).mVis =3D=3D 1 )||( GetCurSldNum() > 1 ) ) } function HasNextSld() { return (GetCurSldNum() !=3D GetNumSlds()) } function CloseWindow() { if( HideMenu() ) return; =09 var event =3D PPTSld.event; if( !IsFramesMode() && event && (event.keyCode=3D=3D27 || event.keyCode=3D= =3D32 || event.type=3D=3D"click" ) ) window.close( self ); CatchNumKeys( self, event ); } function Unload() { gIsEndShow=3D0; } function SetupEndShow() { gIsEndShow=3D1; PPTSld.document.body.scroll=3D"no"; PPTSld.document.onkeypress=3DCloseWindow; PPTSld.document.onclick=3DCloseWindow; PPTSld.document.oncontextmenu=3D_CM; } function EndShow() { if( IsFramesMode() ) return if( PPTSld.event ) PPTSld.event.cancelBubble=3Dtrue doc=3DPPTSld.document var dir =3D doc.body.dir if( dir !=3D "rtl" ) dir =3D "ltr"; doc.open() doc.writeln('


' + ENDSHOW_MESG + '

') doc.close() } function SetSldVisited(){ GetSldList().mList[gCurSld-1].mVisited=3Dtrue } function IsSldVisited(){ return GetSldList().mList[gCurSld-1].mVisited } function hrefList( sldHref, visible, advDelay, advClk ) { this.mSldHref=3D this.mNtsHref =3D sldHref this.mOrigVis=3D this.mVis =3D visible this.mVisited=3D false this.mAdvDelay=3D advDelay this.mAdvOnClk=3D advClk } function SldList(arr,curSld,fEnd) { this.mCurSld =3D curSld; this.mList =3D new Array(); var idx =3D 1; for(ii=3D0;ii 0) { PushSldList(sldList,fEnd); gCurSld =3D 1; } else if( PPTSld.event ) PPTSld.event.cancelBubble=3Dtrue } function PushSldList(arr,fEnd) { var ii =3D gSldStack.length; gSldStack[ii] =3D new SldList(arr,gCurSld,fEnd); GoToSld( gSldStack[ii].mList[0].mSldHref ); } function PopSldList() { if (gSldStack[gSldStack.length-1].fEndShow) EndShow() else { gCurSld =3D gSldStack[gSldStack.length-1].mCurSld; gSldStack[gSldStack.length-1] =3D null; gSldStack.length--; var sldList =3D gSldStack[gSldStack.length-1]; GoToSld( sldList.mList[gCurSld - 1].mSldHref ); } } var custShowList=3Dnew Array(); /********************************************* Navigation button implementation There are 2 types of buttons: ImgBtn, TxtBtn implemented as function objects. They share a similiar interface so the event handlers can call SetActive, for example, on a button=20 object without needing to know exactly=20 what type of button it is. **********************************************/ //---------------------------------- function ImgBtn( oId,bId,w,action ) //---------------------------------- { var t=3Dthis t.Perform =3D _IBP t.SetActive =3D _IBSetA t.SetInactive=3D _IBSetI t.SetPressed =3D _IBSetP t.SetDisabled=3D _IBSetD t.Enabled =3D _IBSetE t.ChangeIcon =3D null t.UserAction =3D action t.ChgState =3D _IBUI t.mObjId =3D oId t.mBorderId=3D bId t.mWidth =3D w t.mIsOn =3D t.mCurState =3D 0 } function _IBSetA() { if( this.mIsOn ) { obj=3Dthis.ChgState( gHiliteClr,gShadowClr,2 ) obj.style.posTop=3D0 } } function _IBSetI() { if( this.mIsOn ) { obj=3Dthis.ChgState( gFaceClr,gFaceClr,1 ) obj.style.posTop=3D0=20 } } function _IBSetP() { if( this.mIsOn ) { obj=3Dthis.ChgState( gShadowClr,gHiliteClr,2 ) obj.style.posLeft+=3D1; obj.style.posTop+=3D1 } } function _IBSetD() { =20 obj=3Dthis.ChgState( gFaceClr,gFaceClr,0 ) obj.style.posTop=3D0=20 } function _IBSetE( state ) { var t=3Dthis GetObj( t.mBorderId ).style.visibility=3D"visible" if( state !=3D t.mIsOn ) { t.mIsOn=3Dstate if( state ) t.SetInactive() else t.SetDisabled() } } function _IBP() { var t=3Dthis if( t.mIsOn ) { if( t.UserAction !=3D null ) t.UserAction() if( t.ChangeIcon ) { obj=3DGetObj(t.mObjId) if( t.ChangeIcon() ) obj.style.posLeft=3Dobj.style.posLeft+(t.mCurState-4)*t.mWidth else obj.style.posLeft=3Dobj.style.posLeft+(t.mCurState-0)*t.mWidth } t.SetActive() } =20 } function _IBUI( clr1,clr2,nextState ) { var t=3Dthis SetBorder( GetObj( t.mBorderId ),clr1,clr2 ) obj=3DGetObj( t.mObjId ) obj.style.posLeft=3Dobj.style.posLeft+(t.mCurState-nextState)*t.mWidth-obj= .style.posTop t.mCurState=3DnextState return obj } //----------------------------------------- function TxtBtn( oId,oeId,action,chkState ) //----------------------------------------- { var t=3Dthis t.Perform =3D _TBP t.SetActive =3D _TBSetA t.SetInactive=3D _TBSetI t.SetPressed =3D _TBSetP t.SetDisabled=3D _TBSetD t.SetEnabled =3D _TBSetE t.GetState =3D chkState t.UserAction =3D action t.ChgState =3D _TBUI t.mObjId =3D oId t.m_elementsId=3D oeId t.mIsOn =3D 1 } function _TBSetA() { var t=3Dthis if( t.mIsOn && !t.GetState() ) t.ChgState( gHiliteClr,gShadowClr,0,0 ) } function _TBSetI() { var t=3Dthis if( t.mIsOn && !t.GetState() ) t.ChgState( gFaceClr,gFaceClr,0,0 ) } function _TBSetP() { if( this.mIsOn ) this.ChgState( gShadowClr,gHiliteClr,1,1 ) } function _TBSetD() { =20 this.ChgState( gFaceClr,gFaceClr,0,0 ) this.mIsOn =3D 0 } function _TBSetE() { var t=3Dthis if( !t.GetState() ) t.ChgState( gFaceClr,gFaceClr,0,0 ) else t.ChgState( gShadowClr,gHiliteClr,1,1 ) t.mIsOn =3D 1 } function _TBP() { var t=3Dthis if( t.mIsOn ) {=20 if( t.UserAction !=3D null ) t.UserAction() if( !t.GetState ) return if( t.GetState() ) t.SetPressed() else t.SetActive() } =20 } function _TBUI( clr1,clr2,lOffset,tOffset ) { SetBorder( GetObj( this.mObjId ),clr1,clr2 ) Offset( GetObj( this.m_elementsId ),lOffset,tOffset ) } function Offset( obj, top, left ){ obj.style.top=3Dtop; obj.style.left=3Dle= ft } function SetBorder( obj, upperLeft, lowerRight ) { s=3Dobj.style; s.borderStyle =3D "solid" s.borderWidth =3D 1=20 s.borderLeftColor =3D s.borderTopColor =3D upperLeft s.borderBottomColor=3D s.borderRightColor =3D lowerRight } function GetBtnObj(){ return gBtnArr[window.event.srcElement.id] } function BtnOnOver(){ b=3DGetBtnObj(); if( b !=3D null ) b.SetActive() } function BtnOnDown(){ b=3DGetBtnObj(); if( b !=3D null ) b.SetPressed() } function BtnOnOut(){ b=3DGetBtnObj(); if( b !=3D null ) b.SetInactive() } function BtnOnUp() { b=3DGetBtnObj() if( b !=3D null ) b.Perform() else Upd() } function GetNtsState(){ return parent.gNtsOpen } function GetOtlState(){ return parent.gOtlOpen } function GetOtlTxtState(){ return parent.gOtlTxtExp } function NtsBtnSetFlag( fVal ) { s=3Ddocument.all.item( this.m_flagId ).style s.display=3D"none" if( fVal ) s.display=3D"" else s.display=3D"none" } function _BSetA_Border(){ b =3D gBtnArr[this.mObjId]; if( b !=3D null ) b.S= etActive() } function _BSetI_Border(){ b =3D gBtnArr[this.mObjId]; if( b !=3D null ) b.S= etInactive() } function _BSetP_Border(){ b =3D gBtnArr[this.mObjId]; if( b !=3D null ) b.S= etPressed() } function _BSetA_BorderImg() {=20 b =3D gBtnArr[this.mBorderId]=20 if( b !=3D null && this.mIsOn && !b.GetState() ) { obj=3Dthis.ChgState( gHiliteClr,gShadowClr,2 ) obj.style.posTop=3D0 } } function _BSetI_BorderImg() {=20 b =3D gBtnArr[this.mBorderId] if( b !=3D null && this.mIsOn && !b.GetState() ) { obj=3Dthis.ChgState( gFaceClr,gFaceClr,1 ) obj.style.posTop=3D0 } } var gHiliteClr=3D"THREEDHIGHLIGHT",gShadowClr=3D"THREEDSHADOW",gFaceClr=3D"= THREEDFACE" var gBtnArr =3D new Array() gBtnArr["nb_otl"] =3D new TxtBtn( "nb_otl","nb_otlElem",parent.ToggleOtlPan= e,GetOtlState ) gBtnArr["nb_otlElem"] =3D new TxtBtn( "nb_otl","nb_otlElem",parent.ToggleOt= lPane,GetOtlState ) gBtnArr["nb_nts"] =3D new ImgBtn( "nb_nts","nb_ntsBorder",10,parent.ToggleN= tsPane ) gBtnArr["nb_nts"].SetActive =3D _BSetA_BorderImg; gBtnArr["nb_nts"].SetInactive =3D _BSetI_BorderImg; gBtnArr["nb_ntsBorder"] =3D new TxtBtn( "nb_ntsBorder","nb_ntsElem",parent.= ToggleNtsPane,GetNtsState ) gBtnArr["nb_ntsElem"] =3D new TxtBtn( "nb_ntsBorder","nb_ntsElem",parent.To= ggleNtsPane,GetNtsState ) gBtnArr["nb_prevBorder"] =3D gBtnArr["nb_prev"]=3D new ImgBtn( "nb_prev","n= b_prevBorder",30,parent.GoToPrevSld ) gBtnArr["nb_nextBorder"] =3D gBtnArr["nb_next"]=3D new ImgBtn( "nb_next","n= b_nextBorder",30,parent.GoToNextSld ) gBtnArr["nb_sldshw"]=3D new ImgBtn( "nb_sldshw","nb_sldshwBorder",18,parent= .FullScreen ) gBtnArr["nb_sldshwBorder"] =3D new TxtBtn( "nb_sldshw","nb_sldshwBorder",pa= rent.FullScreen,null ) gBtnArr["nb_sldshwBorder"].SetActive =3D _BSetA_Border; gBtnArr["nb_sldshwBorder"].SetInactive =3D _BSetI_Border; gBtnArr["nb_sldshwText"] =3D new TxtBtn( "nb_sldshw","nb_sldshwText",parent= .FullScreen,null ) gBtnArr["nb_sldshwText"].SetActive =3D _BSetA_Border; gBtnArr["nb_sldshwText"].SetInactive =3D _BSetI_Border; gBtnArr["nb_voice"] =3D gBtnArr["nb_voiceBorder"] =3D new ImgBtn( "nb_voice= ","nb_voiceBorder",18,parent.ToggleVNarration ) gBtnArr["nb_otlTxtBorder"] =3D gBtnArr["nb_otlTxt"]=3D new ImgBtn( "nb_otlT= xt","nb_otlTxtBorder",23,parent.ToggleOtlText ) gBtnArr["nb_ntsBorder"].m_flagId=3D "nb_nts" gBtnArr["nb_ntsBorder"].SetFlag =3D NtsBtnSetFlag gBtnArr["nb_otlTxt"].ChangeIcon=3D GetOtlTxtState /********************************************* Context menu implementation _CM() is the function that's hooked up to the oncontextmenu event. Once we're asked to show the menu, we first build it by creating DIVs on-the-fly. Then we position it=20 within the screen area so it doesn't get clipped. Creating the DIVs using createElement() means we don't have to write out any extra HTML into the slide HTML files. **********************************************/ var sNext=3D"Next",sPrev=3D"Previous",sEnd=3D"End Show",sFont=3D"Arial",sAr= row=3D"Arrow",sFreeform=3D"Freeform",sRect=3D"Rectangle",sOval=3D"Oval" function ShowMenu() { BuildMenu(); var doc=3DPPTSld.document.body,x=3DPPTSld.event.clientX+doc.scrollLeft,y= =3DPPTSld.event.clientY+doc.scrollTop m =3D PPTSld.document.all.item("ctxtmenu") m.style.pixelLeft=3Dx if( (x+m.scrollWidth > doc.clientWidth)&&(x-m.scrollWidth > 0) ) m.style.pixelLeft=3Dx-m.scrollWidth m.style.pixelTop=3Dy if( (y+m.scrollHeight > doc.clientHeight)&&(y-m.scrollHeight > 0) ) m.style.pixelTop=3Dy-m.scrollHeight m.style.display=3D"" } function _CM() { if( !parent.IsFullScrMode() ) return; if(!PPTSld.event.ctrlKey) { ShowMenu() return false } else HideMenu() } function BuildMenu() { if( PPTSld.document.all.item("ctxtmenu") ) return var mObj=3DCreateItem( PPTSld.document.body ) mObj.id=3D"ctxtmenu" mObj.style.visibility=3D"hidden" var s=3DmObj.style s.position=3D"absolute" s.cursor=3D"default" s.width=3D"120px" SetCMBorder(mObj,"menu","black") var iObj=3DCreateItem( mObj ) SetCMBorder( iObj, "threedhighlight","threedshadow" ) iObj.style.padding=3D2 CreateMenuItem( iObj,sNext,M_GoNextSld,M_True ) CreateMenuItem( iObj,sPrev,M_GoPrevSld,M_HasPrevSld ) =09 CreateSeparator( iObj ) CreateMenuItem( iObj,sEnd,M_End,M_True ) mObj.style.visibility=3D"visible" } function Cancel() { window.event.cancelBubble=3Dtrue; 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charset="windows-1252" Strategies for data analysis: RCTs - Gilda Piaggio ------=_NextPart_01C63AC1.F1FE6CC0 Content-Location: file:///C:/2409C636/RCTs_Analysis_Piaggio_2006_files/outline.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252"
 No= tes
Slide Show
Outline
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