AnyQuest for Windows Questionnaire Definition File Version 2.32+T+ LD+B-A Xa"Arial& Kyri"Arial& Kyri Arial"Arial& Kyri"Arial& Kyri Arial Arial Arial ArialArialG#d+,.+Significance of Evidence in Clinical TrialsSECT@+*@+*T+*$ uX*qA questionnaire for scoring the quality of clinical trials which support the formulation of clinical standards.Adapted for AnyQuest for Windows by Dr. Jrg M. Sigle, AG Klinische konomik, University of Ulm, Germany, and Kunstvolle EDV && Elektronik, 75438 Freudenstein, GermanySECT by Franz Porzsolt, AG Klinische konomik, Dietrich Rothenbacher, Department of Epidemiology, Wilhelm Gaus, Center of Biometrics and Documentation, all from the University of Ulm, Germany, and participants of the Wilsede Workshop October 1995+* +* +*$ uX*Scoring procedureAfter you completed the questionnaire, the total number of "Warning" points and the total SECT-score are computed. Note: Different answer fields may contribute different numbers of points.SECT is divided into the following sections: - Warnings - Design of study - Conduct of study - Analysis of study - Presentation and conclusions of study To be evaluated, a study must not receive more than three points in the first section.+* +*-/$ uX*WarningsDesign of studyP+=(+* jMd(The inclusion criteria are not specified1,00 +w+*gjd(The exclusion criteria are not specified1,00D+|+*jdMlncomplete definition of interventions in study arms (dose, route, schedule)1,00+*+*01$ uX*WarningsConduct of study+=+* jMd<More than 20% of patients were excluded or lost to follow up1,00+wh+*gjd*No description of side effects or toxicity1,00p+*D+*22$ uX*WarningsAnalysis of studyT+=+* jMdNo statistics at all1,00+*+*33$ uX*WarningsPresentation of study+=+* jMd<Negative trial result: beta failure (power) is not discussed1,00+* +*45$ ++uX*WarningsConclusion of study4+=+* jMdFThe conclusion is not confined to the population included in the trial1,00+w(+*gjd5The conclusion is not supported by the presented data1,00v3 v4 v5 v6 v7 5 sum 3 <=adhering to procedures defined by SECT.10D1*1* 1*67$ --uX*Warning!However, you may violate standard scoring procedures and continue the evaluation of the current study. How would you like to proceed?The study you are evaluating scored at least three warning points. Due to SECT standard evaluation procedures, it is not acceptable to support clinical standards, and you should not continue its further evaluation.1=31dBStop further evaluation, adhering to procedures defined by SECT.1,001X31.d.Violate SECT and continue further evaluation.0,00v8 0 =rther evaluation, adhering to procedures defined by SECT.10D1*gs 1)hU$ //uX*Warning!Evaluation of the study was stopped according to the procedures defined by SECT. The study is considered inappropriate to support clinical standards.13 v4 v5 v6 v7 5 sum 3 <<&4JJ t F&4KVF&OuˋN^_;"),!  C:\WINDOWS\MOUSE.INI  %')+ !%). #'+05< $(,0\ 1*l 1*8:$ uX*Design of study"Endpoints of the assessment are...81= 1* jMd7safety and / or effectiveness of a medical intervention1,001gp1*gjdextension of survival and / or improvement of quality of life (i.e. assessment of three quality of life dimensions and of symptoms)4,00H11*jdDboth extension of survival and quality of life (definition as above)2,00@1*P1*;;$ uX*Design of studyDrop out cases1 LT1* jMdsCriteria were prospectively described when to withdraw a patient from the study, or there are only a few drop outs2,001*1*<<$ uX*Design of study Evaluation...1=1* jMd/according to the "intention to treat" principle2,001*1*=A$ uX*Design of studyComparative study with...<1=P1* jMdany control group2,001w1*gjd#concurrent (no historical) controls2,00L1l1*jdrandom allocation to study arms2,001+K1*j[d2standard or placebo as intervention in control arm2,0011*ujd*double blind assessment of study endpoints2,00+*$+*BB$ uX*Conduct of studyNumber of evaluable patients(+=X+* jMd> 50 per group2,00+*t+*CD$ uX*Conduct of study-Number of cases excluded or lost to follow up+=8+* jMd5% - 20% of patients1,00+w+*gjd< 5% of patients2,00+*+*EI$ uX*Conduct of studyDescribed itemsH +=+* jMd*Percentages of drop out patients are given1,00t +w +*gjd"Reasons for drop out are mentioned1,00L+ +*jdWDistribution of prognostic including stratification factors as defined in the protocol1,00h ++K +*j[dComorbidity is described1,00+h +*ujd"Concurrent therapies are described1,00+*+)JK$ uX*Conduct of studyOthers+ M +) iMdqPrognostic and / or stratification factors are balanced or imbalance is considered (e.g. by post-stratification)2,00+w@+)gid<Selection of prognostic factors is supported by reference(s)1,00+*+*LO$ uX*Analysis of studyStatistical analysis+<+* jLdDescriptive analysis2,00X+f0+*fjdBUnivariate analysis (e.g. t-test, log-rank-test, chi-square test)2,00+t+*jdPMultivariate analysis (e.g. logistic regression, cox proportional hazard model)2,00p++K+*j[d9Type I error probability is adjusted for multiple testing2,00+*+*PQ$ uX*%Presentation and conclusions of study Presentation0+<+* jLd%Patient (original) data are available1,00 +v+*fjdConfidence intervals are shown1,00 +*+*RR$ uX*%Presentation and conclusions of study ConclusionsH +< +* jLd3Conclusion provides an answer to the study question2,00 +*X +*+*$ uX*SECT evaluation completed.<Thank you very much for using SECT and AnyQuest for Windows.If you press the "continue"-button, results are calculated, stored to a file and printed immediately if AnyQuest for Windows is configured to do so. d------Warnings - TotalWarnings - TotalWT@nM~@ Undefinedv3 v4 v5 v6 v7 5 sum@d------ Score - Total Score - TotalST@nM~@ Undefined2v10 v11 v12 v13 v14 v15 v16 v17 v18 v19 v20 11 sum +d------Warnings - DesignWarnings - DesignWD@nM~@ Undefinedv3 +d------Warnings - ConductWarnings - ConductWC@nM~@ Undefinedv4| +d------Warnings - AnalysisWarnings - AnalysisWA?nM~@ Undefinedv5 +d------%Warnings - Presentation / Conclusions%Warnings - Presentation / ConclusionsWPC@nM~@ Undefinedv6+d------Score - DesignScore - DesignSD@nM~@ Undefinedv10 v11 v12 v13 4 sum`+d------Score - ConductScore - ConductSC@nM~@ Undefinedv14 v15 v16 v17 4 sum +d------Score - AnalysisScore - AnalysisSA@nM~@ Undefinedv18L+d------"Score - Presentation / Conclusions"Score - Presentation / ConclusionsSPC@nM~@ Undefined v19 v20 2 sumSECT - Significance of Evidence in Clinical Trials by Franz Porzsolt, Dietrich Rothenbacher, Wilhelm Gaus, all from the University of Ulm, Germany, and participants of the Wilsede Workshop October 1995, adapted for AnyQuest for Windows by Jrg M. Sigle, 23.06.97 cosmetically revised by Dr. Jrg Sigle, 23.03.2000