- Email: [email protected]
Subject index for volume 15
Subject Index ACE INitl3lTOR Survival of Myocardial Infarction I&ng Term Evaluation (SMEX) Study: Rationale, Design, Organization, and Outcome Definitions, 201 ANALYSIS OF COVARIANCE Estimating Sample Sizes for Repeated Measurement Designs. I00 ANALYSIS OF VARIANCE Estimating Sample Sizes for Repeated Measurement Designs, 1% ASSIGNMENT METHODS Reporting of Assignment Methods in Clinical Trials, 29-l AUTOCORRELATION Sample Size Estimation Using Repeated Measurements on Biomarkers as Outcomes, 165 BASAL CELL CARCINOMA The Nambour Skin Cancer and Actinic Eye Disease Prevention Trial: l&+-r and Baseline Characteristics of Participanb, 512 BASELINX CORRECTION Estiniating Sample Sizes for Repeated Measurement Designs, 100 BAYESIAN INFERENCE A bay&an Approach to Establishing Sample Size and Monitoring Criteria for Phase II Clinical Trials, 463 Simple %yesian Analysis in Clinical Trials: A Tutorial, 349 BCG VACCINE Field Trials of Tuberculosis Vaccines: HOW Couid We Have Done Them Bet tc i?, 247 BIOLOGICAL MAMERS Sample Size Estimation Using Repeated Measurements on Biomarkers as OutcomC3,165
Controlled Chical Trials If W-534 11994) 0 Elder ScienceIre 1994 455 Avenue of the Americas, New York, New York, lOOlO
BIVARIATE RESPONSES Interim Monitoring of Bivariate Responses Using Repeated Confidence Intervals, 187 BLOOD PRESSURE MEASUREMENT Ciinicallly Relevant Measures?, 328 An Optimal Rule for Screening Subjects for Clinical Trials in the Presence of Within-Person Variability, 173 BONE ‘MARROW TRA.NSPLANT.\TION Simulation as a Design Tool for Phase l/II Clinical Trials: An Example from k?e MdITOW Transplantation, 4% BUBBLE SORTING Extewion of One-Sided Test to Multiple Treatment Trials, 124 CANCER CHEMOTHERAPY A Bayesian Approach to Establishing Sample Size and Monitoring Criteria for Phase 11Clinical Trials, 463 CANCER SCREENING issues in the Mortality Analysis of Randomized Controlled Trials of Cancer Screening, 81 CARDIAC REHABILITATION Design of the Training Ievels Comparison Trial, 59 CATARACT The Namborrr Skin Cancer and Actinic Eye Disease Prevention Trial: Design and Baseline CharacteristGcs of Participants. 512 CAUSALITY Suspended Judgmer*i: Assessing Cause and Effect !roq Trials: A Cautionary Note, 331 CHART Is Double Data ~:t&ry Necessary? The CHART Trials. 482
527 om-2456/94/$?.00
Subject Index for Voiume 15
528 CHOLESTEROL LOWERlNG From Clinical Trials to Clinical Practice:
Generalizing from Participant to Patient, 7 Generalizing from Clinical Trials, 11 CLINICAL F’RACTICE Introduction: From Clinical Trials +o Clinical Practice[mIFour Papers from a Plenary Session, 5 CLINICAL TRIAL(S) Design of the Training Levels Comparison Trial, 59 Echocardiography in Multicenter Clinical Trials: Experience from the Treatment of Mild EIypertension Study, 395 Features of the Nutrient Database and Analysis System for the Modification of Diet in Renal Disease Stzdy, 44 Field TriaIs of Tuberculosis Vaccine% HOW Could We Have Done Them Better?, 247 Introduction: From Clinical Trials to Clinical Practice[mj+:oru Papers from a Plenary Session, 5 Is Double Data Entry Necessary? The CHART Trials, 4X! An Optimal Rule for Screening Subjects for Clinical Trials in the Presence of Within-Person Variability, 173 Recruiting Hard-to-Reach Subjects: Is It Worth the Effort?, 154 Reporting of Assignment Methods in Clinical Trials, 294 Simulation as a Design Tool for Phase l/II Clinical Trials: An Example from Bone Marrow Transplantation, 450 Survival of Myocardial Infarction LongTerm Evaluation (SMlLE) Study: Rationale, Design, organization, and Outcome Defini lions, 201 Suspended Judgment: Reactions to the Motion Picture ‘T_orenzo’sOil,’ 161 CLINICAL TRIAL DESIGN The Advanced Glaucoma Intervention Study (AGIS): 1. Study Design and Methods and lseline Characteristics of Study Patients, 299 A Bay&an Approach to Establishing Sample Size and Monitoring Criteria for Phase II Clinical Trials, 463 The Nambour Skin Cancer and Actinic
Eye Disease Prevention Trial: Design and Baseiins Characteristics of Partieipnts, 512 Simulation as a Design Tool for Phase I/II Clinical Trials: AR Example from Bone Marrow Transplantation, 450 Survival of Myocardial Infarction LongTerm Evaluation (SMILE) Study: Rationale, Design, Organization, and Outcome Definitions, 201 CLINICAL TRIAL METHODOLOGY From Clinical Trials to Clinical Practice: Generalizing from ParticiFnt to Patient, 7 Generalizing from Clinical Trials, II Intercept Studies, Clinical Trials, and CIuster Experiments: To Whom Can We Extrapolate?, 24 CLOSE-OUT QUESTIONNAiZ!E Patient Perception of a Long-term Clinical Trial: Experience Using a Clowout Questionnaire in the Studies of lmft Ventricular Dysfunction (SOLVD) Trial, 284 COMMUNITY-BASED TRIALS Data Management for Large Community Trials in Nepal, 220 COMPLIANCE Recruiting Hard-to-Reach Subjects: 1s It Worth the Effort?, 154 COMPUTING Data Management for Large Community Trials in Nepal, 220 CONFIDENCE INTERVALS The Case for Confidence Intervals in Controlled Clinical Trials, 411 Interim Monitoring of Bivariate Responses Using Repeated Confidence Intervals, 187 CONFIDENCE LIMITS The Case for Confidence Intervals in Controlled Clinical Trials, 411 CONSOLIDATED SAFETY DATA A New Proposal for Benefit-Less-Risk Analysis in Clinical Trials, 30 CONTINUOWS MONITORING A Bay&an Approach to Establishing Sample Size and Moritoring
Subj
index for Volume 15
Criteria for Phase II Clinical Trials, 463 COHTROLLED CLINICAL TRIALS The Case for Confidence Intervals in Contrdled Chical Trials, 411 COST EFFECDFENSS An Optimal Rule for %eenir.g Subjects for Clinical Ttials in :‘clePresence of Within-Person Variabili$T, i3 DATA MANAGEMENT Data Management for Large Community Trials in Nepal, 220 DATA PROCESSING Data Management for Large Community Trials in Nepal, 220 DECISION MAKiNG Decision Making during a Phase 111 Randomized Controiled Trial, 360
529 DRUG TRIALS Suspnded Judgement: Seeing Through the DoubleMasked Design: A Commentary, 244 EARLY STOPPlNG An Efficient Multiple-Stage Procedure for Phase II Clinical Trials that Have High Response Rate Objectives, 277 ECHOCARDIOGRAPHY Echocardiography in Multicenter Clinical Trials Experience from the Treatment of Mild Hypertension Study, 395 EDITORIALS Farewell Swan Song (editorial), 235 EFFECT SIZE The -Case for Confidence Intervals in Controlled Clildcal Trials, 411 EFFICACY
DIET Features of the Nutrient Database and Analysis System for the Modification of Diet in Renal Disease Shady, 44 DIETARY ANALYSIS Features of the Nutrient Database irnd Analysis System for the Modification of Diet in Renal Disease Study, 44 DIFFERENCE SCORES Estimating Sample Sizes for Repented Measurement Designs, lot) DISCOUNTING PROCEDURE A New Proposal for Benefit-Lpss-Risk Analysis in Clinical Trials, 30
TnterimMonitoring
of Bivariat? Responses Using Repeated Confidence Intervals, 187
EQUIVALENCE TRIALS Interim Monitoring of Bivariate Responses Wing Repeated Confidence Intervals, 187 ERRATA, 326 EXERCISE Design of the Training LeveIs Comparison Trial, 59 FACTORIAL DESIGN Power Considerations for Testing an Interaction in a 2 x k Factorial Design with a Failure Time
Outcome, 489 DLSCOVERY IN MEDICM Suspended J*dpent: Ignorance and the Process of Learning and Discovery in Medicine, 1 DOUBLE DATA ENTRY Is Double Dal1 Entry Necessary? The CHART Trials, 481 DDURLE-MASKED DESIGN Suspended Judgement: Seeing Through the Doubl&ia&d Design: A Commentary, 244
FAILURE TIME Power Considerations for Tizsting an Interaction in a 2 x k Factorial &sign with a Failure Time outcome, 489 GASTROESOPHAGEAL REFLUX DISEASE Development for and Rest&s of the Use of a Gastroesophageal Reflux Disease Activity Index as an Outcome Variable in a Clinical Trial, 335
Subject Index for Volume 15
530 GEHAN’S TWO-STAGE PROCEDURE An Efficient Mu;ltiple--Stage Procedure for Phase II Clinical Trials that Have High Response II~i?tcObjectives, 277 GENERALIZATION From Clinical Trials to Clinical Practice: Generalizing from Participant to Patient, 7 Generalizing from Clinical Trials, 11 Generalizing the Results of Randomized Clinical Trials, 15 Intercept Studies, Clinical Trials, and Cluster Experiments: To Whom Can We Extrapolate?, 24 GLAUCOMA The Advanced Glaucoma Intervention Study (AG19: 1. Study Design and Methods and Baseline Characteristics of Study Patients, 29!J GROUP SEQUENTIAL DESIGN Interim Monitoring of Bivariate Responses Using Repated
Confidence
CIuster Experiments: To Whom Can We Extrapolate?, 24 LASER SURGERY The Advanced Glaucoma Intervention Study (AGIS): 1. Study Design and Methods and Baseline Characteristics of Study Patients, 299 LEARNING Suspended Judgment: Ignorance and the Process of Learning and Discovery in Medicine, ‘I LEFT VENTRICULAR DYSFUNCTION (SOLVD) Patient Percepriun of a Lmg-term Clinical Trial: Experience Using a Close-out Questionnaire in the Studies of -I.& Ventricular Dysfunction (SOLVD) Trial, 2&4 LETTERS TO THE EDITOR, 523 A Note on Sampie Size Determination for Comparison of Small Probabilities, 77
Intervals, 187 HETEROGENEITY Generalizing the Results of Randomized Clinical Trials, I5 WV-1
Sample Size Estimation Using Repeated Measurements on Biomarkers as Outcomes, 165 HYPERTENSION Echocardiography in Multicenter Clinical Trials: Experience from the Treatment of Mild Hypertension Study, 395 HYPOTHESIS TESTING The Case for Confidence Intervals in Controlled Clinical Trials, 411 Generalizing the Results of Randomized Clinical Trials, 15 INTERACTION Power Considerations for Testing an Interaction in a 2 x k Factorial Design with a Failure Time Outcome, 488 INTERCEPT STIJDiES Intercept Stud&, Clinical Trials, and
LINEAR TREND TESTS Estimating Sample Sizes for Repeated Measurement D&gns, I00 LONG-TERM CLINICAL TRIAL Patient Perception of a Long-term Clinical Trial: Experience Using a Close-out Questionnaire in the Studies of Lzft
Ventricular Dysfunction (SQLVD) Trial, 284 LONGITUDINAL STUDIES Sample Size Estimation Using Repeated Measurements on Biornarkers as Outcomes, 16 ZORENZO’S
OIL
Suspended Judgment: Reactions to the Motion Picture ‘Lorenzo’s Oil,’ 161 MANAGEMEN’T TRIALS Power Function Arguments in Support of an Altema tive Approach for Analyzing Management Trials, 211 MANTEL-HAENSZEL ESTIMATOR A Comparison of Two Methods of Estimating a Common Risk Difference in a Stratified An;ilysis of a Multicenter Clinical Trial, 135
Subjt
Index for Volume 15
531
MEDICAL PRACTICE Scientific Knewledge and C$cial consensus, 432
METHODOLOGY Recruiting Hard-to-Reach Subjects: Is It Worth the Effort?, 154 MORlCIZlNE Moricizine and Quality of Life in the Cardiac Arrhythmia Suppression Trial II (CAST II), 437 MOR’I-ALlTY ANALYSIS Issues in the Mortality Analysis of Randomized Controlled Trials of Cancer Screening, 81 MULTICENTER TRIAL The Latin American Multicenter Trial on Psychosocial Support During Pregnancy: Methodology and Baseline Comparability, 379 MULTIPLE 2 x 2 TABLES A Comparison of Two Methods of Estimating a Common Risk Difference in a Stratified Analysis of a Multicenter Clinical Trial, I35 MULTIPLE COMPARISON Extension of One-Sided Test to Multiple Treatment Trials, 124 MULTIPLE LIT rAR REGRESSION Development ror and Results of +e Use of a Gastroesophageal Reflux Disease Activity Index as an Outcome Variable in a Clinical Trial, 335 MULTlPLE STEP Extension of On&id& Tat to Multiple Treatment Trials, I24 MYOCARDIAL INFARaON Moricizine and Quality of Life in the Cardiac Arrhythmia Suppression Trial II (CAST II), 437 Survival of Myocardial Infarction LongTen-n Evaluation (SMILE) Study: Rationale, Design, Organization, and Outcome Definitions, 201 NEPAL Data Management for Large Community Trials in Nepal, 220 NEUTRON THERAPY Simple Bay&an ,5+sis
in Ciinkal
Trials: A Tutorial, 349 NON-NULL HYPOTHESIS Power Function Arguments in Support of an Alternative Approach for Analyzing Management Trials, 211 NUTRIENT CALCULATION Features of the Nutrient Data’base and Analysis System for the Modification. of Diet in Renal Disease Study, 44 NUTRIENT’ DATABASE Features of the Nutrient Database and Analysis System for the Modification of Diet in Renal Disease Study, 44 ODDS RAT10 Simple Bayesian An;ilysis in Clinical Trill- A Tutorial, 349 ONE-SIDED TEST Extension of One-Sided Test to Mdtiple Treatment Trials, 124 OPEN-ANGLE GLAUCOMA The Advanced GIaucoma Intervention Study IAGIS): 1. Study Design and Methods and Baseline Characteristics of Study Pa tie&, 299 OUTCOME VAR [ABLE Development for and &ufts of the Use of a Gastroesophageal Reflux Disease Activity Index as an Outcome Variable in a CIinicai Trial, 335 PLENARY SESSION Intrcductionr From CIinicai Trials to Clinical Practice[m]Four Papers from a Plenary Session, 5 POWER Estimating Sample Sizes for Repeated Measurement Designs, 100 Power Considerations for Testing an Interaction in a 2 x k Factorial Design with a Failure Time Outcome, 489 POWER FUNCTION Power Function Arguments in Support of an Alternative Approach for Analyzing Management Trials, 211
Subject Index for Volume 15
532 PROBABILITIES a Note on Sample Size Determination for Compzrrson of Small Probabilities (letter), 77
REJECTION ZRIWW An Efficient MuIt$+6tage Procedure for Phase II Clinical Triais thit Have High Response Rate Objectives, 277
PROPQRTIONALITY CONSTANT A New I’rapbsal for Benefit-tiRisk Analysis in Clini~l Trials, 30
RENAL DISEASE Features of the Nutrient Database and Analysis System for the Modification of Diet in Renal Disease Study, 44
P§YCHOTROPIC DRUGS Suspended Judgement: Seeing Through the IlnublpMasked Design: A Commentary, 244 QUALITATIVE INTERACTION Generalizing the Results of Randomized Clinica Trials, 15 QUALIT? OF LIFE Moricizine and Quality of Life in the Cardiac Arrhythmia Suppression Trial 11(CAST II), 437 QUERIES Clinicallly Relevant Measures?, 328 RANDOMIZATION Reporting of Assignment Methods in Clinical Trials, 294 RANDOMIZED CLINICAL TRIALS Generalizing the Results of Randomized Clinical Trials, 15 Is Double Data Entry Necessary? The CHART Trials, 482 Moricizine and Quality of Life in the Cardiac Arrhythmia SupprBsion Trial II (CAST II), 4$7
REPEATED CONFIDENCE INTERVALS lnkrim Monitoring of Bivariate Responses Using Rep&d Confidence Intervals, 187 RRPEATED MEASUREMENTS Development for and Results of the Use of a Gastroesophageal Reflux l&ease htivity Index as an Outcome Variable in a Clinical Trial, 335 Estimating Sample Sizea for Repeated Measurement Designs, IO0 RESPONSE RATE An Efficient Multiple-Stage Procedure for Phase II Clinical Trials that Have High Response Rate Objectives, 27’7 RISK-ADJUSTED BENFFIT A New Proposal for Benefit-txz-zRisk Anal;& in Clinical Trials, _?o SAFETY PROFILE A New Proposal for Benefit-Less-Risk Analysis in Clinical Trials, 30
RANDOMIZED CONTROLLED TRIALS Decision Making during a Phase 111 Randomized Controlled Trial, 360 .Issues in the Mortality Analysis of Randomized Controlled Trials of Calrcer Screening, 61 The Latin American Multicenter Trial an Psychosocial Support During Pregnancy: Methodology and Baseline Comparability, 379 The Ottawa Stroke Trials Registry Collaborative Group and the Deirelopment i bcthe Ottawa Stroke Trials ,Pegistry (OSTR),
SAMPLE SIZE The Case for Confidence Intervals in Controlled Clinical Trials, 411 Estimating Sample Sizes for Repeated Measurement Designs, 100 Extension of One-Sided Test to Multiple Treatment Trials, 124 A Note on Sample Size Determination for Comparison of Small Probabilities (letter), 77 Power Cons;derations for Testing an Interaction in a 2 x k Factorial Design with a Failure Time Outcome, 4$9 Sample Size Estimation Using Repeated Measurements on Biomarkers as Outcomes, 16.5
RECRUITMENT Recruiting Hard-to-Reach Subjects: 1s It Worth the Effort?, 154
SCIENTIFIC KNOWLEDGE Scientific Knowledge and Social consensus, 432
Subject Index for Volume 15
533
SCREENING An Optimal Rule for Screening Subjects
for Clinical Mals in the Presence of Within-Person
Variability,
173
SELECTION Extension of OneSided Test to Multiple Treatment Trials, 124 SEQUENTIAL DESIGN An Efficient Multiple-Stage Procedure for Phase II Clinical Trials that Have High Response Rate i%jectives, 277 SIGNIFANCE TEST The Case for Confidence Intervals in Controlled Clinical Trials, 411 SMILE TRIAL Survival of Myoczrdial Infarction LongTerm Y-paluation (SMILE) Study: Rationale, Design, Organization, and Outccrm~ Definitions, 201 SOClAL CONSENSUS Scientific Knowledge and Social consensus, 432 SOClAL SUPPORT The Latin American Multicenter Trial on Psychosocial Support During Pregnancy: Methodology and Baseline Comparability, 379 STATISTICAL PRECISION The Case for Confidence Intervals in Controlled Cliniral Trials, 411 STATISTICAL SIGNEHICANCE The Case for Confidence Intervals Controlled
Clinica
SYMMETRY ASSUMPTION Estimating Sampk Sizes for Repeated Measurement Designs, 100
in Trials, 411
STROKE The Ottawa Stroke Trials Registry Collaborative Group and the bvelopment of the Ottawa Stroke Trials Registry (OSTR), SUSPENDED JUDGMENT AssessingCause and Effect from Trials: A Cautionary Note, 331 Ignorance and the Process of Learning and Discovery in Medicine, 1 Reactions to +-te Motion Picture tirenz~q’s Gil,’ 161 Seeing Throqh the Double-Masked Design: A Commentary, 244
~.ABECXJLECXOMY The Adv.a~.zd Glaucoma Intervention Study [AGIS): 1. Study Design and Methods and Baseline Characteristics of Study Patients, 299 TRAINING LEVELS COMPARISON TRIAL Design of the Training Levels Comparison Trial, 59 TRIAL COlrlPARISON Design of the Training Levels Comparison Trial, 59 TRIAL ORGANIZATION Survival of Myocardial Infarction LongTerm Evaluation (SMILE) Study: Rationale, Design, Organization, and Outcome Definitions, 201 TUBERCULOSlS Field TriaIs oi Tubercu!osis Vaccines: Mow Could We Have Done Them Better?, 247 UNCONTROLLED CLINICAL TRIAL Suspended Judgment: Reactions to the Motion Picture ‘Lorecv~o’s Oil,’ I61 VACCJNfS Field Trirris of Tukrculosis Vaccines: How Could We Have Done Them Better?, 247 VISUAL ACUITY The Advanced Glaucoma Intervention Study (AGIS): 1. Study Design and Methods and Saseline Characteristics of Study Patients, 299 VISUAL FIELDS The Advanced Glaucoma Intervention Study (AGIS): 1. Study Design and Methods and Baseline Characteristics of Study Patienti, 299 VITAMIN A Data Management for Large Communi”Ly Trials in NeDal. 1 ~220
Subject Index for Volume 15
534 WLXXTRD
LEAST SQUARES ESTIMATOP A Comparison of Two Methods of
Estimating a Common Risk Difference jn a Stratified Analysis of a Multicenter Clinical Trial, 135
Controlled Chical Trials If W-534 11994) 0 Elder ScienceIre 1994 455 Avenue of the Americas, New York, New York, lOOlO
BIVARIATE RESPONSES Interim Monitoring of Bivariate Responses Using Repeated Confidence Intervals, 187 BLOOD PRESSURE MEASUREMENT Ciinicallly Relevant Measures?, 328 An Optimal Rule for Screening Subjects for Clinical Trials in the Presence of Within-Person Variability, 173 BONE ‘MARROW TRA.NSPLANT.\TION Simulation as a Design Tool for Phase l/II Clinical Trials: An Example from k?e MdITOW Transplantation, 4% BUBBLE SORTING Extewion of One-Sided Test to Multiple Treatment Trials, 124 CANCER CHEMOTHERAPY A Bayesian Approach to Establishing Sample Size and Monitoring Criteria for Phase 11Clinical Trials, 463 CANCER SCREENING issues in the Mortality Analysis of Randomized Controlled Trials of Cancer Screening, 81 CARDIAC REHABILITATION Design of the Training Ievels Comparison Trial, 59 CATARACT The Namborrr Skin Cancer and Actinic Eye Disease Prevention Trial: Design and Baseline CharacteristGcs of Participants. 512 CAUSALITY Suspended Judgmer*i: Assessing Cause and Effect !roq Trials: A Cautionary Note, 331 CHART Is Double Data ~:t&ry Necessary? The CHART Trials. 482
527 om-2456/94/$?.00
Subject Index for Voiume 15
528 CHOLESTEROL LOWERlNG From Clinical Trials to Clinical Practice:
Generalizing from Participant to Patient, 7 Generalizing from Clinical Trials, 11 CLINICAL F’RACTICE Introduction: From Clinical Trials +o Clinical Practice[mIFour Papers from a Plenary Session, 5 CLINICAL TRIAL(S) Design of the Training Levels Comparison Trial, 59 Echocardiography in Multicenter Clinical Trials: Experience from the Treatment of Mild EIypertension Study, 395 Features of the Nutrient Database and Analysis System for the Modification of Diet in Renal Disease Stzdy, 44 Field TriaIs of Tuberculosis Vaccine% HOW Could We Have Done Them Better?, 247 Introduction: From Clinical Trials to Clinical Practice[mj+:oru Papers from a Plenary Session, 5 Is Double Data Entry Necessary? The CHART Trials, 4X! An Optimal Rule for Screening Subjects for Clinical Trials in the Presence of Within-Person Variability, 173 Recruiting Hard-to-Reach Subjects: Is It Worth the Effort?, 154 Reporting of Assignment Methods in Clinical Trials, 294 Simulation as a Design Tool for Phase l/II Clinical Trials: An Example from Bone Marrow Transplantation, 450 Survival of Myocardial Infarction LongTerm Evaluation (SMlLE) Study: Rationale, Design, organization, and Outcome Defini lions, 201 Suspended Judgment: Reactions to the Motion Picture ‘T_orenzo’sOil,’ 161 CLINICAL TRIAL DESIGN The Advanced Glaucoma Intervention Study (AGIS): 1. Study Design and Methods and lseline Characteristics of Study Patients, 299 A Bay&an Approach to Establishing Sample Size and Monitoring Criteria for Phase II Clinical Trials, 463 The Nambour Skin Cancer and Actinic
Eye Disease Prevention Trial: Design and Baseiins Characteristics of Partieipnts, 512 Simulation as a Design Tool for Phase I/II Clinical Trials: AR Example from Bone Marrow Transplantation, 450 Survival of Myocardial Infarction LongTerm Evaluation (SMILE) Study: Rationale, Design, Organization, and Outcome Definitions, 201 CLINICAL TRIAL METHODOLOGY From Clinical Trials to Clinical Practice: Generalizing from ParticiFnt to Patient, 7 Generalizing from Clinical Trials, II Intercept Studies, Clinical Trials, and CIuster Experiments: To Whom Can We Extrapolate?, 24 CLOSE-OUT QUESTIONNAiZ!E Patient Perception of a Long-term Clinical Trial: Experience Using a Clowout Questionnaire in the Studies of lmft Ventricular Dysfunction (SOLVD) Trial, 284 COMMUNITY-BASED TRIALS Data Management for Large Community Trials in Nepal, 220 COMPLIANCE Recruiting Hard-to-Reach Subjects: 1s It Worth the Effort?, 154 COMPUTING Data Management for Large Community Trials in Nepal, 220 CONFIDENCE INTERVALS The Case for Confidence Intervals in Controlled Clinical Trials, 411 Interim Monitoring of Bivariate Responses Using Repeated Confidence Intervals, 187 CONFIDENCE LIMITS The Case for Confidence Intervals in Controlled Clinical Trials, 411 CONSOLIDATED SAFETY DATA A New Proposal for Benefit-Less-Risk Analysis in Clinical Trials, 30 CONTINUOWS MONITORING A Bay&an Approach to Establishing Sample Size and Moritoring
Subj
index for Volume 15
Criteria for Phase II Clinical Trials, 463 COHTROLLED CLINICAL TRIALS The Case for Confidence Intervals in Contrdled Chical Trials, 411 COST EFFECDFENSS An Optimal Rule for %eenir.g Subjects for Clinical Ttials in :‘clePresence of Within-Person Variabili$T, i3 DATA MANAGEMENT Data Management for Large Community Trials in Nepal, 220 DATA PROCESSING Data Management for Large Community Trials in Nepal, 220 DECISION MAKiNG Decision Making during a Phase 111 Randomized Controiled Trial, 360
529 DRUG TRIALS Suspnded Judgement: Seeing Through the DoubleMasked Design: A Commentary, 244 EARLY STOPPlNG An Efficient Multiple-Stage Procedure for Phase II Clinical Trials that Have High Response Rate Objectives, 277 ECHOCARDIOGRAPHY Echocardiography in Multicenter Clinical Trials Experience from the Treatment of Mild Hypertension Study, 395 EDITORIALS Farewell Swan Song (editorial), 235 EFFECT SIZE The -Case for Confidence Intervals in Controlled Clildcal Trials, 411 EFFICACY
DIET Features of the Nutrient Database and Analysis System for the Modification of Diet in Renal Disease Shady, 44 DIETARY ANALYSIS Features of the Nutrient Database irnd Analysis System for the Modification of Diet in Renal Disease Study, 44 DIFFERENCE SCORES Estimating Sample Sizes for Repented Measurement Designs, lot) DISCOUNTING PROCEDURE A New Proposal for Benefit-Lpss-Risk Analysis in Clinical Trials, 30
TnterimMonitoring
of Bivariat? Responses Using Repeated Confidence Intervals, 187
EQUIVALENCE TRIALS Interim Monitoring of Bivariate Responses Wing Repeated Confidence Intervals, 187 ERRATA, 326 EXERCISE Design of the Training LeveIs Comparison Trial, 59 FACTORIAL DESIGN Power Considerations for Testing an Interaction in a 2 x k Factorial Design with a Failure Time
Outcome, 489 DLSCOVERY IN MEDICM Suspended J*dpent: Ignorance and the Process of Learning and Discovery in Medicine, 1 DOUBLE DATA ENTRY Is Double Dal1 Entry Necessary? The CHART Trials, 481 DDURLE-MASKED DESIGN Suspended Judgement: Seeing Through the Doubl&ia&d Design: A Commentary, 244
FAILURE TIME Power Considerations for Tizsting an Interaction in a 2 x k Factorial &sign with a Failure Time outcome, 489 GASTROESOPHAGEAL REFLUX DISEASE Development for and Rest&s of the Use of a Gastroesophageal Reflux Disease Activity Index as an Outcome Variable in a Clinical Trial, 335
Subject Index for Volume 15
530 GEHAN’S TWO-STAGE PROCEDURE An Efficient Mu;ltiple--Stage Procedure for Phase II Clinical Trials that Have High Response II~i?tcObjectives, 277 GENERALIZATION From Clinical Trials to Clinical Practice: Generalizing from Participant to Patient, 7 Generalizing from Clinical Trials, 11 Generalizing the Results of Randomized Clinical Trials, 15 Intercept Studies, Clinical Trials, and Cluster Experiments: To Whom Can We Extrapolate?, 24 GLAUCOMA The Advanced Glaucoma Intervention Study (AG19: 1. Study Design and Methods and Baseline Characteristics of Study Patients, 29!J GROUP SEQUENTIAL DESIGN Interim Monitoring of Bivariate Responses Using Repated
Confidence
CIuster Experiments: To Whom Can We Extrapolate?, 24 LASER SURGERY The Advanced Glaucoma Intervention Study (AGIS): 1. Study Design and Methods and Baseline Characteristics of Study Patients, 299 LEARNING Suspended Judgment: Ignorance and the Process of Learning and Discovery in Medicine, ‘I LEFT VENTRICULAR DYSFUNCTION (SOLVD) Patient Percepriun of a Lmg-term Clinical Trial: Experience Using a Close-out Questionnaire in the Studies of -I.& Ventricular Dysfunction (SOLVD) Trial, 2&4 LETTERS TO THE EDITOR, 523 A Note on Sampie Size Determination for Comparison of Small Probabilities, 77
Intervals, 187 HETEROGENEITY Generalizing the Results of Randomized Clinical Trials, I5 WV-1
Sample Size Estimation Using Repeated Measurements on Biomarkers as Outcomes, 165 HYPERTENSION Echocardiography in Multicenter Clinical Trials: Experience from the Treatment of Mild Hypertension Study, 395 HYPOTHESIS TESTING The Case for Confidence Intervals in Controlled Clinical Trials, 411 Generalizing the Results of Randomized Clinical Trials, 15 INTERACTION Power Considerations for Testing an Interaction in a 2 x k Factorial Design with a Failure Time Outcome, 488 INTERCEPT STIJDiES Intercept Stud&, Clinical Trials, and
LINEAR TREND TESTS Estimating Sample Sizes for Repeated Measurement D&gns, I00 LONG-TERM CLINICAL TRIAL Patient Perception of a Long-term Clinical Trial: Experience Using a Close-out Questionnaire in the Studies of Lzft
Ventricular Dysfunction (SQLVD) Trial, 284 LONGITUDINAL STUDIES Sample Size Estimation Using Repeated Measurements on Biornarkers as Outcomes, 16 ZORENZO’S
OIL
Suspended Judgment: Reactions to the Motion Picture ‘Lorenzo’s Oil,’ 161 MANAGEMEN’T TRIALS Power Function Arguments in Support of an Altema tive Approach for Analyzing Management Trials, 211 MANTEL-HAENSZEL ESTIMATOR A Comparison of Two Methods of Estimating a Common Risk Difference in a Stratified An;ilysis of a Multicenter Clinical Trial, 135
Subjt
Index for Volume 15
531
MEDICAL PRACTICE Scientific Knewledge and C$cial consensus, 432
METHODOLOGY Recruiting Hard-to-Reach Subjects: Is It Worth the Effort?, 154 MORlCIZlNE Moricizine and Quality of Life in the Cardiac Arrhythmia Suppression Trial II (CAST II), 437 MOR’I-ALlTY ANALYSIS Issues in the Mortality Analysis of Randomized Controlled Trials of Cancer Screening, 81 MULTICENTER TRIAL The Latin American Multicenter Trial on Psychosocial Support During Pregnancy: Methodology and Baseline Comparability, 379 MULTIPLE 2 x 2 TABLES A Comparison of Two Methods of Estimating a Common Risk Difference in a Stratified Analysis of a Multicenter Clinical Trial, I35 MULTIPLE COMPARISON Extension of One-Sided Test to Multiple Treatment Trials, 124 MULTIPLE LIT rAR REGRESSION Development ror and Results of +e Use of a Gastroesophageal Reflux Disease Activity Index as an Outcome Variable in a Clinical Trial, 335 MULTlPLE STEP Extension of On&id& Tat to Multiple Treatment Trials, I24 MYOCARDIAL INFARaON Moricizine and Quality of Life in the Cardiac Arrhythmia Suppression Trial II (CAST II), 437 Survival of Myocardial Infarction LongTen-n Evaluation (SMILE) Study: Rationale, Design, Organization, and Outcome Definitions, 201 NEPAL Data Management for Large Community Trials in Nepal, 220 NEUTRON THERAPY Simple Bay&an ,5+sis
in Ciinkal
Trials: A Tutorial, 349 NON-NULL HYPOTHESIS Power Function Arguments in Support of an Alternative Approach for Analyzing Management Trials, 211 NUTRIENT CALCULATION Features of the Nutrient Data’base and Analysis System for the Modification. of Diet in Renal Disease Study, 44 NUTRIENT’ DATABASE Features of the Nutrient Database and Analysis System for the Modification of Diet in Renal Disease Study, 44 ODDS RAT10 Simple Bayesian An;ilysis in Clinical Trill- A Tutorial, 349 ONE-SIDED TEST Extension of One-Sided Test to Mdtiple Treatment Trials, 124 OPEN-ANGLE GLAUCOMA The Advanced GIaucoma Intervention Study IAGIS): 1. Study Design and Methods and Baseline Characteristics of Study Pa tie&, 299 OUTCOME VAR [ABLE Development for and &ufts of the Use of a Gastroesophageal Reflux Disease Activity Index as an Outcome Variable in a CIinicai Trial, 335 PLENARY SESSION Intrcductionr From CIinicai Trials to Clinical Practice[m]Four Papers from a Plenary Session, 5 POWER Estimating Sample Sizes for Repeated Measurement Designs, 100 Power Considerations for Testing an Interaction in a 2 x k Factorial Design with a Failure Time Outcome, 489 POWER FUNCTION Power Function Arguments in Support of an Alternative Approach for Analyzing Management Trials, 211
Subject Index for Volume 15
532 PROBABILITIES a Note on Sample Size Determination for Compzrrson of Small Probabilities (letter), 77
REJECTION ZRIWW An Efficient MuIt$+6tage Procedure for Phase II Clinical Triais thit Have High Response Rate Objectives, 277
PROPQRTIONALITY CONSTANT A New I’rapbsal for Benefit-tiRisk Analysis in Clini~l Trials, 30
RENAL DISEASE Features of the Nutrient Database and Analysis System for the Modification of Diet in Renal Disease Study, 44
P§YCHOTROPIC DRUGS Suspended Judgement: Seeing Through the IlnublpMasked Design: A Commentary, 244 QUALITATIVE INTERACTION Generalizing the Results of Randomized Clinica Trials, 15 QUALIT? OF LIFE Moricizine and Quality of Life in the Cardiac Arrhythmia Suppression Trial 11(CAST II), 437 QUERIES Clinicallly Relevant Measures?, 328 RANDOMIZATION Reporting of Assignment Methods in Clinical Trials, 294 RANDOMIZED CLINICAL TRIALS Generalizing the Results of Randomized Clinical Trials, 15 Is Double Data Entry Necessary? The CHART Trials, 482 Moricizine and Quality of Life in the Cardiac Arrhythmia SupprBsion Trial II (CAST II), 4$7
REPEATED CONFIDENCE INTERVALS lnkrim Monitoring of Bivariate Responses Using Rep&d Confidence Intervals, 187 RRPEATED MEASUREMENTS Development for and Results of the Use of a Gastroesophageal Reflux l&ease htivity Index as an Outcome Variable in a Clinical Trial, 335 Estimating Sample Sizea for Repeated Measurement Designs, IO0 RESPONSE RATE An Efficient Multiple-Stage Procedure for Phase II Clinical Trials that Have High Response Rate Objectives, 27’7 RISK-ADJUSTED BENFFIT A New Proposal for Benefit-txz-zRisk Anal;& in Clinical Trials, _?o SAFETY PROFILE A New Proposal for Benefit-Less-Risk Analysis in Clinical Trials, 30
RANDOMIZED CONTROLLED TRIALS Decision Making during a Phase 111 Randomized Controlled Trial, 360 .Issues in the Mortality Analysis of Randomized Controlled Trials of Calrcer Screening, 61 The Latin American Multicenter Trial an Psychosocial Support During Pregnancy: Methodology and Baseline Comparability, 379 The Ottawa Stroke Trials Registry Collaborative Group and the Deirelopment i bcthe Ottawa Stroke Trials ,Pegistry (OSTR),
SAMPLE SIZE The Case for Confidence Intervals in Controlled Clinical Trials, 411 Estimating Sample Sizes for Repeated Measurement Designs, 100 Extension of One-Sided Test to Multiple Treatment Trials, 124 A Note on Sample Size Determination for Comparison of Small Probabilities (letter), 77 Power Cons;derations for Testing an Interaction in a 2 x k Factorial Design with a Failure Time Outcome, 4$9 Sample Size Estimation Using Repeated Measurements on Biomarkers as Outcomes, 16.5
RECRUITMENT Recruiting Hard-to-Reach Subjects: 1s It Worth the Effort?, 154
SCIENTIFIC KNOWLEDGE Scientific Knowledge and Social consensus, 432
Subject Index for Volume 15
533
SCREENING An Optimal Rule for Screening Subjects
for Clinical Mals in the Presence of Within-Person
Variability,
173
SELECTION Extension of OneSided Test to Multiple Treatment Trials, 124 SEQUENTIAL DESIGN An Efficient Multiple-Stage Procedure for Phase II Clinical Trials that Have High Response Rate i%jectives, 277 SIGNIFANCE TEST The Case for Confidence Intervals in Controlled Clinical Trials, 411 SMILE TRIAL Survival of Myoczrdial Infarction LongTerm Y-paluation (SMILE) Study: Rationale, Design, Organization, and Outccrm~ Definitions, 201 SOClAL CONSENSUS Scientific Knowledge and Social consensus, 432 SOClAL SUPPORT The Latin American Multicenter Trial on Psychosocial Support During Pregnancy: Methodology and Baseline Comparability, 379 STATISTICAL PRECISION The Case for Confidence Intervals in Controlled Cliniral Trials, 411 STATISTICAL SIGNEHICANCE The Case for Confidence Intervals Controlled
Clinica
SYMMETRY ASSUMPTION Estimating Sampk Sizes for Repeated Measurement Designs, 100
in Trials, 411
STROKE The Ottawa Stroke Trials Registry Collaborative Group and the bvelopment of the Ottawa Stroke Trials Registry (OSTR), SUSPENDED JUDGMENT AssessingCause and Effect from Trials: A Cautionary Note, 331 Ignorance and the Process of Learning and Discovery in Medicine, 1 Reactions to +-te Motion Picture tirenz~q’s Gil,’ 161 Seeing Throqh the Double-Masked Design: A Commentary, 244
~.ABECXJLECXOMY The Adv.a~.zd Glaucoma Intervention Study [AGIS): 1. Study Design and Methods and Baseline Characteristics of Study Patients, 299 TRAINING LEVELS COMPARISON TRIAL Design of the Training Levels Comparison Trial, 59 TRIAL COlrlPARISON Design of the Training Levels Comparison Trial, 59 TRIAL ORGANIZATION Survival of Myocardial Infarction LongTerm Evaluation (SMILE) Study: Rationale, Design, Organization, and Outcome Definitions, 201 TUBERCULOSlS Field TriaIs oi Tubercu!osis Vaccines: Mow Could We Have Done Them Better?, 247 UNCONTROLLED CLINICAL TRIAL Suspended Judgment: Reactions to the Motion Picture ‘Lorecv~o’s Oil,’ I61 VACCJNfS Field Trirris of Tukrculosis Vaccines: How Could We Have Done Them Better?, 247 VISUAL ACUITY The Advanced Glaucoma Intervention Study (AGIS): 1. Study Design and Methods and Saseline Characteristics of Study Patients, 299 VISUAL FIELDS The Advanced Glaucoma Intervention Study (AGIS): 1. Study Design and Methods and Baseline Characteristics of Study Patienti, 299 VITAMIN A Data Management for Large Communi”Ly Trials in NeDal. 1 ~220
Subject Index for Volume 15
534 WLXXTRD
LEAST SQUARES ESTIMATOP A Comparison of Two Methods of
Estimating a Common Risk Difference jn a Stratified Analysis of a Multicenter Clinical Trial, 135