Subject Index for Volume 28

Subject Index for Volume 28 ACUTE MYOCARDIAL INFARCTION A unicenter, randomized, double-blind, parallelgroup, placebo-controlled study of Melatonin as an Adjunct in patients with acute myocaRdial Infarction undergoing primary Angioplasty: The Melatonin Adjunct in the acute MyocaRdial Infarction treated with Angioplasty (MARIA) trial: Study design and rationale, 532 ADAPTIVE DESIGN An adaptive approach for bivariate phase II clinical trial designs, 482 Flexible design of two-stage adaptive procedures for phase III clinical trials, 500 ADHERENCE The Take Control of Your Blood pressure (TCYB) study: Study design and methodology, 33 The medication Adherence and Blood Pressure Control (ABC) trial: A multi-site randomized controlled trial in a hypertensive, multicultural, economically disadvantaged population, 459 Randomized controlled trials of positive affect and self-affirmation to facilitate healthy behaviors in patients with cardiopulmonary diseases: Rationale, trial design, and methods, 748 ADOLESCENT A rationale and method for high-intensity progressive resistance training with children and adolescents, 442 ADVERSE EVENT Cognitive testing in early-phase clinical trials: Development of a rapid computerized test battery and application in a simulated Phase I study, 391 AEROBIC Design paper: The DEMO trial: A randomized, parallel-group, observer-blinded clinical trial of aerobic versus non-aerobic versus relaxation training for patients with light to moderate depression, 79 doi:10.1016/S1551-7144(07)00139-5

AFRICA Involving communities in the design of clinical trial protocols: The BAN Study in Lilongwe, Malawi, 59 AFRICAN AMERICANS An RCT of the effect of motivational interviewing on medication adherence in hypertensive African Americans: Rationale and design, 169 A perspective on African American participation in clinical trials, 213 AFRICAN-AMERICANS The medication Adherence and Blood Pressure Control (ABC) trial: A multi-site randomized controlled trial in a hypertensive, multi-cultural, economically disadvantaged population, 459 AGING The Dehydroepiandrosterone And WellNess (DAWN) study: Research design and methods, 153 ALPHA ADRENERGIC ANTAGONIST Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of AvodartR and Tamsulosin) trial rationale and study design, 770 5-ALPHA-REDUCTASE INHIBITORS Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of AvodartR and Tamsulosin) trial rationale and study design, 770 ALS Characteristics associated with participation in DNA banking: The National Registry of Veterans with ALS, 572 ANALYSIS OF COVARIANCE Randomized clinical trials with a pre- and a posttreatment measurement: Repeated measures versus ANCOVA models, 713

Subject Index for Volume 28

ANGIOPLASTY Randomized controlled trials of positive affect and self-affirmation to facilitate healthy behaviors in patients with cardiopulmonary diseases: Rationale, trial design, and methods, 748 ANTERIOR CRUCIATE LIGAMENT INJURIES The challenge of recruiting patients with anterior cruciate ligament injury of the knee into a randomized clinical trial comparing surgical and non-surgical treatment, 295 ANTIDEPRESSANT A kinetic-pharmacodynamic model for clinical trial simulation of antidepressant action: Application to clomipramine–lithium interaction, 276

785

The effect of omitted covariates on confidence interval and study power in binary outcome analysis: A simulation study, 242 BIVARIATE BINARY ENDPOINTS An adaptive approach for bivariate phase II clinical trial designs, 482 BLOOD PRESSURE Rationale, design, and methods for the risk evaluation and communication health outcomes and utilization trial (REACH OUT), 662 BLOOD PRESSURE CONTROL The Take Control of Your Blood pressure (TCYB) study: Study design and methodology, 33

ANTIDEPRESSANTS Clinical trials and the response rate illusion, 348

BOOTSTRAP Comparison of antitumor activities in tumor xenograft treatment, 115

ASTHMA A matched crossover design for clinical trials, 638 Randomized controlled trials of positive affect and self-affirmation to facilitate healthy behaviors in patients with cardiopulmonary diseases: Rationale, trial design, and methods, 748

BP The medication Adherence and Blood Pressure Control (ABC) trial: A multi-site randomized controlled trial in a hypertensive, multi-cultural, economically disadvantaged population, 459

ATTRITION IN CLINICAL TRIALS Factors associated with loss to follow-up in a large tuberculosis treatment trial (TBTC Study 22), 288

BPH Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of AvodartR and Tamsulosin) trial rationale and study design, 770

AUTOMATED CALLS Lessons and pitfalls of interactive voice response in medical research, 593 BARRIERS Implementation of electronic data capture systems: Barriers and solutions, 329 BEHAVIOR CHANGE Randomized controlled trials of positive affect and self-affirmation to facilitate healthy behaviors in patients with cardiopulmonary diseases: Rationale, trial design, and methods, 748 BEHAVIORAL THERAPY Design of the Behavior Enhances Drug Reduction of Incontinence (BE-DRI) study, 48

BREAST CANCER Patient recruitment into a randomised controlled trial of supervised exercise therapy in sedentary women treated for breast cancer, 603 BREAST NEOPLASMS Decision-making and breast cancer clinical trial: How experience challenges attitudes, 684 CANCER Improving the design of phase II trials of cytostatic anticancer agents, 138 Optimizing randomized phase II trials assessing tumor progression, 146

BEVACIZUMAB Endpoints for agents that slow tumor growth, 18

CARDIOPULMONARY DISEASES Randomized controlled trials of positive affect and self-affirmation to facilitate healthy behaviors in patients with cardiopulmonary diseases: Rationale, trial design, and methods, 748

BIAS Optimizing randomized phase II trials assessing tumor progression, 146

CENTER EFFECT Sample size calculation for multicenter randomized trial: Taking the center effect into account, 451

786

Subject Index for Volume 28

CHILDREN A rationale and method for high-intensity progressive resistance training with children and adolescents, 442 CLINICAL PRACTICE GUIDELINES Value of recruitment strategies used in a primary care practice-based trial, 258 CLINICAL RESEARCH Creating a culture of research, 557 CLINICAL TRIAL Predictors of attendance and dropout at the Lung Health Study 11-year follow-up, 25 The Take Control of Your Blood pressure (TCYB) study: Study design and methodology, 33 Involving communities in the design of clinical trial protocols: The BAN Study in Lilongwe, Malawi, 59 The Dehydroepiandrosterone And WellNess (DAWN) study: Research design and methods, 153 Cognitive testing in early-phase clinical trials: Development of a rapid computerized test battery and application in a simulated Phase I study, 391 Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of AvodartR and Tamsulosin) trial rationale and study design, 770 CLINICAL TRIAL RECRUITMENT Clinical trial optimization: Monte Carlo simulation Markov model for planning clinical trials recruitment, 220 CLINICAL TRIAL SIMULATION A kinetic-pharmacodynamic model for clinical trial simulation of antidepressant action: Application to clomipramine–lithium interaction, 276 CLINICAL TRIALS Dependence, hyper-dependence and hypothesis testing in clinical trials, 68 Random-effects model for meta-analysis of clinical trials: An update, 105 A perspective on African American participation in clinical trials, 213 Phase II multi-step planning methods in oncology: Comparison, recommendations and potential applications, 249 Clinical trials and the response rate illusion, 348 Predicting where future means will lie based on the results of the current trial, 352 Presentation in relation to publication of results from clinical trials, 358 The role of the consent document in informed consent for pediatric leukemia trials, 401

Costs of recruiting couples to a clinical trial, 423 Ethical issues in clinical trials involving nanomedicine, 433 Creating a culture of research, 557 Factors associated with early study discontinuation in AACTG studies, DACS 200, 583 An adaptive Simon Two-Stage Design for Phase 2 studies of targeted therapies, 654 Diagnostic criteria and adjudication process both determine published event-rates: The ACTION trial experience, 720 CLOMIPRAMINE A kinetic-pharmacodynamic model for clinical trial simulation of antidepressant action: Application to clomipramine–lithium interaction, 276 CLUSTER ANALYSIS Cluster-crossover design: A method for limiting clusters level effect in community-intervention studies, 316 CLUSTER RANDOMISED CONTROLLED TRIALS Recruitment issues when primary care population clusters are used in randomised controlled clinical trials: Climbing mountains or pushing boulders uphill?, 232 CLUSTER RANDOMIZED TRIAL Design and analysis of stepped wedge cluster randomized trials, 182 CLUSTER-RANDOMISED TRIALS Measuring improved targeting of health interventions to the poor in the context of a communityrandomised trial in rural India, 382 COCAINE Prevalence of abnormal liver-associated enzymes in cocaine experienced adults versus healthy volunteers during Phase 1 clinical trials, 695 COGNITION Cognitive testing in early-phase clinical trials: Development of a rapid computerized test battery and application in a simulated Phase I study, 391 COGSTATE Cognitive testing in early-phase clinical trials: Development of a rapid computerized test battery and application in a simulated Phase I study, 391 COLLABORATIVE CARE MODEL A perspective on African American participation in clinical trials, 213

Subject Index for Volume 28

COMBINATION THERAPY Design, statistical analysis and sample size calculation of dose response study of telmisartan and hydrochlorothiazide, 647 COMBINED MODALITY THERAPY Design of the Behavior Enhances Drug Reduction of Incontinence (BE-DRI) study, 48 COMMUNICATION A randomised trial of the effects of an additional communication strategy on recruitment into a large-scale, multi-centre trial, 1

787

CONFIDENCE INTERVALS Predicting where future means will lie based on the results of the current trial, 352 CONSENT DOCUMENT The role of the consent document in informed consent for pediatric leukemia trials, 401 CONTRACEPTION Design of a stage-matched intervention trial to increase dual method contraceptive use (Project PROTECT), 626

COMMUNICATION WITH USERS Implementation of electronic data capture systems: Barriers and solutions, 329

CONTRACT RESEARCH ORGANIZATIONS (CROS) Industry-sponsored research in developing countries, 677

COMMUNITY HEALTH CENTERS The medication Adherence and Blood Pressure Control (ABC) trial: A multi-site randomized controlled trial in a hypertensive, multi-cultural, economically disadvantaged population, 459

CONTROLLED CLINICAL TRIAL Step into Motion: A randomized trial examining the relative efficacy of Internet vs. print-based physical activity interventions, 737

COMPARISON CURVE Comparison of antitumor activities in tumor xenograft treatment, 115 COMPETING PROJECTS Implementation of electronic data capture systems: Barriers and solutions, 329 COMPUTER ASSISTED Examination of print and telephone channels for physical activity promotion: Rationale, design, and baseline data from Project STRIDE, 90 COMPUTER TELEPHONY INTERACTIVE Lessons and pitfalls of interactive voice response in medical research, 593 CONDITIONAL POWER Flexible design of two-stage adaptive procedures for phase III clinical trials, 500 CONDOMS Design of a stage-matched intervention trial to increase dual method contraceptive use (Project PROTECT), 626 CONFIDENCE INTERVAL The effect of omitted covariates on confidence interval and study power in binary outcome analysis: A simulation study, 242 Flexible design of two-stage adaptive procedures for phase III clinical trials, 500

CORONARY ARTERY BYPASS GRAFTING, CABG The Best Bypass Surgery Trial: Rationale and design of a randomized clinical trial with blinded outcome assessment of conventional versus off-pump coronary artery bypass grafting, 540 CORONARY ARTERY BYPASS SURGERY The Best Bypass Surgery Trial: Rationale and design of a randomized clinical trial with blinded outcome assessment of conventional versus off-pump coronary artery bypass grafting, 540 CORONARY ARTERY DISEASE Randomized controlled trials of positive affect and self-affirmation to facilitate healthy behaviors in patients with cardiopulmonary diseases: Rationale, trial design, and methods, 748 CORONARY HEART DISEASE Rationale, design, and methods for the risk evaluation and communication health outcomes and utilization trial (REACH OUT), 662 COST Value of recruitment strategies used in a primary care practice-based trial, 258 Costs of recruiting couples to a clinical trial, 423 COSTS A randomized trial of PET scanning to improve diagnostic yield of direct laryngoscopy in patients with suspicion of recurrent laryngeal carcinoma after radiotherapy, 705

788

Subject Index for Volume 28

COUPLES Costs of recruiting couples to a clinical trial, 423 COVERAGE PROBABILITY Interval estimation of risk ratio in the simple compliance randomized trial, 120 CRITICAL EVENTS COMMITTEE Diagnostic criteria and adjudication process both determine published event-rates: The ACTION trial experience, 720 CROSSOVER Cluster-crossover design: A method for limiting clusters level effect in community-intervention studies, 316 CROSSOVER DESIGN A matched crossover design for clinical trials, 638 CTI Lessons and pitfalls of interactive voice response in medical research, 593 DATA ANALYSIS Clinical trials and the response rate illusion, 348 DECISION-MAKING Examination of print and telephone channels for physical activity promotion: Rationale, design, and baseline data from Project STRIDE, 90 DECISION MAKING Decision-making and breast cancer clinical trials: How experience challenges attitudes, 684 DEHYDROEPIANDROSTERONE The Dehydroepiandrosterone And WellNess (DAWN) study: Research design and methods, 153 DEPENDENCE Dependence, hyper-dependence and hypothesis testing in clinical trials, 68 DEPRESSION Design paper: The DEMO trial: A randomized, parallel-group, observer-blinded clinical trial of aerobic versus non-aerobic versus relaxation training for patients with light to moderate depression, 79 Assessing Physicians’ Use of Treatment Algorithms: Project IMPACTS Study Design and Rationale, 192 Screening for Auditory Impairment Which Hearing Assessment Test (SAI-WHAT): RCT design and baseline characteristics, 303

DEVELOPED Industry-sponsored research in developing countries, 677 DEVELOPING Industry-sponsored research in developing countries, 677 DHT Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of AvodartR and Tamsulosin) trial rationale and study design, 770 DIABETES Rationale and design of the AdRem study: Evaluating the effects of blood pressure lowering and intensive glucose control on vascular retinal disorders in patients with type 2 diabetes mellitus, 6 A rationale and method for high-intensity progressive resistance training with children and adolescents, 442 DIAGNOSTIC ADJUDICATION PROCEDURES Diagnostic criteria and adjudication process both determine published event-rates: The ACTION trial experience, 720 DIAGNOSTIC CLASSIFICATION Diagnostic criteria and adjudication process both determine published event-rates: The ACTION trial experience, 720 DIET The clinical trial of Women On the Move through Activity and Nutrition (WOMAN) study, 370 Effects of an exercise intervention on other health behaviors in overweight/obese post-menopausal women, 472 DISSEMINATION OF RESULTS Presentation in relation to publication of results from clinical trials, 358 DIVERSITY Costs of recruiting couples to a clinical trial, 423 DNA BANKING Characteristics associated with participation in DNA banking: The National Registry of Veterans with ALS, 572

Subject Index for Volume 28

DOSE RESPONSE SURFACE Design, statistical analysis and sample size calculation of dose response study of telmisartan and hydrochlorothiazide, 647 DRUG THERAPY Design of the Behavior Enhances Drug Reduction of Incontinence (BE-DRI) study, 48 DUAL METHOD USE Design of a stage-matched intervention trial to increase dual method contraceptive use (Project PROTECT), 626 DUTASTERIDE Delay in the progression of low-risk prostate cancer: Rationale and design of the Reduction by Dutasteride of Clinical Progression Events in Expectant Management (REDEEM) trial, 763 DYADS Costs of recruiting couples to a clinical trial, 423 EARLY STOPPING RULES Methods of joint evaluation of efficacy and toxicity in phase II clinical trials, 514 EDC Lessons and pitfalls of interactive voice response in medical research, 593 EFFICACY Interval estimation of risk ratio in the simple compliance randomized trial, 120 EFFICIENCY Interval estimation of risk ratio in the simple compliance randomized trial, 120 ELECTRONIC DATA CAPTURE Implementation of electronic data capture systems: Barriers and solutions, 329 Lessons and pitfalls of interactive voice response in medical research, 593 ELECTRONIC MEDICAL RECORDS Assessing Physicians’ Use of Treatment Algorithms: Project IMPACTS Study Design and Rationale, 192 EMERGENCY MEDICATION Including multiple imputation in a sensitivity analysis for clinical trials with treatment failures, 130 ENDPOINT ANALYSES Dependence, hyper-dependence and hypothesis testing in clinical trials, 68

789

ENROLLMENT A perspective on African American participation in clinical trials, 213 EQUITY Measuring improved targeting of health interventions to the poor in the context of a communityrandomised trial in rural India, 382 ETHICS Involving communities in the design of clinical trial protocols: The BAN Study in Lilongwe, Malawi, 59 Ethical issues in clinical trials involving nanomedicine, 433 EVENT-RATES Diagnostic criteria and adjudication process both determine published event-rates: The ACTION trial experience, 720 EXERCISE Design paper: The DEMO trial: A randomized, parallel-group, observer-blinded clinical trial of aerobic versus non-aerobic versus relaxation training for patients with light to moderate depression, 79 Examination of print and telephone channels for physical activity promotion: Rationale, design, and baseline data from Project STRIDE, 90 The clinical trial of Women On the Move through Activity and Nutrition (WOMAN) study, 370 Patient recruitment into a randomised controlled trial of supervised exercise therapy in sedentary women treated for breast cancer, 603 EXPECTANT MANAGEMENT Delay in the progression of low-risk prostate cancer: Rationale and design of the Reduction by Dutasteride of Clinical Progression Events in Expectant Management (REDEEM) trial, 763 EXPERT SYSTEMS Examination of print and telephone channels for physical activity promotion: Rationale, design, and baseline data from Project STRIDE, 90 FACTORIAL DESIGN Design, statistical analysis and sample size calculation of dose response study of telmisartan and hydrochlorothiazide, 647 FDG–PET A randomized trial of PET scanning to improve diagnostic yield of direct laryngoscopy in patients with suspicion of recurrent laryngeal carcinoma after radiotherapy, 705

790

Subject Index for Volume 28

FLEMING’S MULTI-STEP PROCEDURE Phase II multi-step planning methods in oncology: Comparison, recommendations and potential applications, 249 FRAMINGHAM Rationale, design, and methods for the risk evaluation and communication health outcomes and utilization trial (REACH OUT), 662 GENERAL LINEAR A matched crossover design for clinical trials, 638 GENERALIZED LEAST SQUARES Randomized clinical trials with a pre- and a posttreatment measurement: Repeated measures versus ANCOVA models, 713 GOMPERTZIAN KINETICS Endpoints for agents that slow tumor growth, 18 GRAPHICAL USER INTERFACE Implementation of electronic data capture systems: Barriers and solutions, 329 GROUP SEQUENTIAL DESIGN Methods of joint evaluation of efficacy and toxicity in phase II clinical trials, 514 HEALTH BEHAVIORS Effects of an exercise intervention on other health behaviors in overweight/obese post-menopausal women, 472 HEALTH OUTCOMES A perspective on African American participation in clinical trials, 213 HEALTH PROMOTION Step into Motion: A randomized trial examining the relative efficacy of Internet vs. print-based physical activity interventions, 737 HEALTHCARE DISPARITIES A perspective on African American participation in clinical trials, 213

HIV Involving communities in the design of clinical trial protocols: The BAN Study in Lilongwe, Malawi, 59 HIV VACCINE TRIALS Starting from scratch: Program development and lessons learned from HIV vaccine trial counseling in Thailand, 409 HOMOGENEITY Testing homogeneity of the risk ratio in stratified noncompliance randomized trials, 614 HORMONE THERAPY The clinical trial of Women On the Move through Activity and Nutrition (WOMAN) study, 370 HYDROCHLOROTHIAZIDE Design, statistical analysis and sample size calculation of dose response study of telmisartan and hydrochlorothiazide, 647 HYPERTENSION Rationale and design of the AdRem study: Evaluating the effects of blood pressure lowering and intensive glucose control on vascular retinal disorders in patients with type 2 diabetes mellitus, 6 The Take Control of Your Blood pressure (TCYB) study: Study design and methodology, 33 An RCT of the effect of motivational interviewing on medication adherence in hypertensive African Americans: Rationale and design, 169 The medication Adherence and Blood Pressure Control (ABC) trial: A multi-site randomized controlled trial in a hypertensive, multi-cultural, economically disadvantaged population, 459 Rationale, design, and methods for the risk evaluation and communication health outcomes and utilization trial (REACH OUT), 662 Randomized controlled trials of positive affect and self-affirmation to facilitate healthy behaviors in patients with cardiopulmonary diseases: Rationale, trial design, and methods, 748 IDENTIFICATION OF BRIDGERS Implementation of electronic data capture systems: Barriers and solutions, 329

HEARING AIDS Screening for Auditory Impairment– Which Hearing Assessment Test (SAI-WHAT): RCT design and baseline characteristics, 303

IMPLEMENTATION Implementation of electronic data capture systems: Barriers and solutions, 329

HEARING LOSS Screening for Auditory Impairment– Which Hearing Assessment Test (SAI-WHAT): RCT design and baseline characteristics, 303

INDIA Measuring improved targeting of health interventions to the poor in the context of a community-randomised trial in rural India, 382

Subject Index for Volume 28

INDIVIDUALLY TAILORED Step into Motion: A randomized trial examining the relative efficacy of Internet vs. printbased physical activity interventions, 737 INDUSTRY Industry-sponsored research in developing countries, 677 INFORMED CONSENT The role of the consent document in informed consent for pediatric leukemia trials, 401 Characteristics associated with participation in DNA banking: The National Registry of Veterans with ALS, 572 Lack of correlation between satisfaction and knowledge in clinical trials participants: A pilot study, 730 INPATIENT TRIALS Prevalence of abnormal liver-associated enzymes in cocaine experienced adults versus healthy volunteers during Phase 1 clinical trials, 695 INSULIN RESISTANCE A rationale and method for high-intensity progressive resistance training with children and adolescents, 442 INTENT-TO-TREAT Including multiple imputation in a sensitivity analysis for clinical trials with treatment failures, 130 INTERACTIVE VOICE RESPONSE SYSTEMS Lessons and pitfalls of interactive voice response in medical research, 593 INTERIM ANALYSIS Group sequential t-test for clinical trials with small sample sizes across stages, 563 INTERNET Step into Motion: A randomized trial examining the relative efficacy of Internet vs. print-based physical activity interventions, 737

791

INTERVENTIONS The medication Adherence and Blood Pressure Control (ABC) trial: A multi-site randomized controlled trial in a hypertensive, multi-cultural, economically disadvantaged population, 459 INTRACLASS CORRELATION COEFFICIENT Sample size calculation for multicenter randomized trial: Taking the center effect into account, 451 IVR Lessons and pitfalls of interactive voice response in medical research, 593 IVRS Lessons and pitfalls of interactive voice response in medical research, 593 JOINT EFFICACY AND TOXICITY Methods of joint evaluation of efficacy and toxicity in phase II clinical trials, 514 KENWARD AND ROGER’S ADJUSTMENT Randomized clinical trials with a pre- and a posttreatment measurement: Repeated measures versus ANCOVA models, 713 KNEE INJURIES The challenge of recruiting patients with anterior cruciate ligament injury of the knee into a randomized clinical trial comparing surgical and non-surgical treatment, 295 LARYNGEAL CARCINOMA A randomized trial of PET scanning to improve diagnostic yield of direct laryngoscopy in patients with suspicion of recurrent laryngeal carcinoma after radiotherapy, 705 LARYNGOSCOPY A randomized trial of PET scanning to improve diagnostic yield of direct laryngoscopy in patients with suspicion of recurrent laryngeal carcinoma after radiotherapy, 705

INTERVENTION Effects of an exercise intervention on other health behaviors in overweight/obese post-menopausal women, 472

LEUKEMIA The role of the consent document in informed consent for pediatric leukemia trials, 401

INTERVENTION STUDIES Examination of print and telephone channels for physical activity promotion: Rationale, design, and baseline data from Project STRIDE, 90

LITHIUM A kinetic-pharmacodynamic model for clinical trial simulation of antidepressant action: Application to clomipramine–lithium interaction, 276

792

Subject Index for Volume 28

LIVER-ASSOCIATED ENZYMES Prevalence of abnormal liver-associated enzymes in cocaine experienced adults versus healthy volunteers during Phase 1 clinical trials, 695 LOGISTIC REGRESSION The effect of omitted covariates on confidence interval and study power in binary outcome analysis: A simulation study, 242 LOSS OF POWER A permutation test for a weighted–KaplanMeier estimator with application to the nutritional prevention of cancer trial, 343 LOSS TO FOLLOW-UP Factors associated with loss to follow-up in a large tuberculosis treatment trial (TBTC Study 22), 288 LOST-TO-FOLLOW-UP Factors associated with early study discontinuation in AACTG studies, DACS 200, 583 LUNG HEALTH STUDY Predictors of attendance and dropout at the Lung Health Study 11-year follow-up, 25 MARKOV MODELS Clinical trial optimization: Monte Carlo simulation Markov model for planning clinical trials recruitment, 220 MATCHED DESIGN A matched crossover design for clinical trials, 638 MEASUREMENT-BASED CARE (MBC) Assessing Physicians’ Use of Treatment Algorithms: Project IMPACTS Study Design and Rationale, 192 MEDICAL INFORMATION TECHNOLOGY Assessing Physicians’ Use of Treatment Algorithms: Project IMPACTS Study Design and Rationale, 192 MEDICATION The medication Adherence and Blood Pressure Control (ABC) trial: A multi-site randomized controlled trial in a hypertensive, multi-cultural, economically disadvantaged population, 459 MEDICATION ADHERENCE An RCT of the effect of motivational interviewing on medication adherence in hypertensive African Americans: Rationale and design, 169

MEGA TRIAL Mega-trials vs. meta-analysis: Precision vs. heterogeneity?, 324 MELATONIN A unicenter, randomized, double-blind, parallelgroup, placebo-controlled study of Melatonin as an Adjunct in patients with acute myocaRdial Infarction undergoing primary Angioplasty: The Melatonin Adjunct in the acute MyocaRdial Infarction treated with Angioplasty (MARIA) trial: Study design and rationale, 532 META-ANALYSIS Random-effects model for meta-analysis of clinical trials: An update, 105 Mega-trials vs. meta-analysis: Precision vs. heterogeneity?, 324 METHODOLOGY Epidemiology and reporting of randomized trials employing re-randomization of patient groups: A systematic survey, 268 Step into Motion: A randomized trial examining the relative efficacy of Internet vs. print-based physical activity interventions, 737 MIDAZOLAM Cognitive testing in early-phase clinical trials: Development of a rapid computerized test battery and application in a simulated Phase I study, 391 MINORITIES A perspective on African American participation in clinical trials, 213 MINORITY INVESTIGATORS A perspective on African American participation in clinical trials, 213 MIXED-EFFECTS MODEL A matched crossover design for clinical trials, 638 MIXED MODELS Cluster-crossover design: A method for limiting clusters level effect in community-intervention studies, 316 MODERATE- AND HIGH-RISK PATIENTS The Best Bypass Surgery Trial: Rationale and design of a randomized clinical trial with blinded outcome assessment of conventional versus off-pump coronary artery bypass grafting, 540 MOLECULAR-TARGETED THERAPY Improving the design of phase II trials of cytostatic anticancer agents, 138

Subject Index for Volume 28

MONTE CARLO SIMULATION Clinical trial optimization: Monte Carlo simulation Markov model for planning clinical trials recruitment, 220 MOTIVATIONAL INTERVIEWING An RCT of the effect of motivational interviewing on medication adherence in hypertensive African Americans: Rationale and design, 169 MULTI-CENTRE A randomised trial of the effects of an additional communication strategy on recruitment into a large-scale, multi-centre trial, 1 MULTICENTER RANDOMIZED TRIAL Sample size calculation for multicenter randomized trial: Taking the center effect into account, 451 MULTIPLE ENDPOINTS Dependence, hyper-dependence and hypothesis testing in clinical trials, 68 MULTIPLICITY Dependence, hyper-dependence and hypothesis testing in clinical trials, 68 NANOMEDICINE Ethical issues in clinical trials involving nanomedicine, 433 NANOTECHNOLOGY Ethical issues in clinical trials involving nanomedicine, 433 NON-AEROBIC Design paper: The DEMO trial: A randomized, parallel-group, observer-blinded clinical trial of aerobic versus non-aerobic versus relaxation training for patients with light to moderate depression, 79 NONCOMPLIANCE Testing homogeneity of the risk ratio in stratified noncompliance randomized trials, 614 NONPARAMETRIC A permutation test for a weighted Kaplan–Meier estimator with application to the nutritional prevention of cancer trial, 343 NURSE CASE MANAGEMENT The medication Adherence and Blood Pressure Control (ABC) trial: A multi-site randomized controlled trial in a hypertensive, multi-cultural, economically disadvantaged population, 459

793

OBESITY A rationale and method for high-intensity progressive resistance training with children and adolescents, 442 Effects of an exercise intervention on other health behaviors in overweight/obese post-menopausal women, 472 ODDS RATIO An adaptive approach for bivariate phase II clinical trial designs, 482 OFF-PUMP CORONARY ARTERY BYPASS, OPCAB The Best Bypass Surgery Trial: Rationale and design of a randomized clinical trial with blinded outcome assessment of conventional versus off-pump coronary artery bypass grafting, 540 OMITTED COVARIATE The effect of omitted covariates on confidence interval and study power in binary outcome analysis: A simulation study, 242 OPTIMIZATION OF CLINICAL TRIALS Clinical trial optimization: Monte Carlo simulation Markov model for planning clinical trials recruitment, 220 OUTCOME MEASURES Measuring improved targeting of health interventions to the poor in the context of a communityrandomised trial in rural India, 382 OVERACTIVE BLADDER Design of the Behavior Enhances Drug Reduction of Incontinence (BE-DRI) study, 48 P VALUE Flexible design of two-stage adaptive procedures for phase III clinical trials, 500 PARTICIPANT CHARACTERISTICS Characteristics associated with participation in DNA banking: The National Registry of Veterans with ALS, 572 PARTICIPANT KNOWLEDGE Lack of correlation between satisfaction and knowledge in clinical trials participants: A pilot study, 730 PARTICIPANT SATISFACTION Lack of correlation between satisfaction and knowledge in clinical trials participants: A pilot study, 730

794

Subject Index for Volume 28

PARTICIPATION Predictors of attendance and dropout at the Lung Health Study 11-year follow-up, 25 PATIENT AND HEALTHCARE PROVIDER EDUCATION PRODIACOR: A patient-centered treatment program for type 2 diabetes and associated cardiovascular risk factors in the city of Corrientes, Argentina: Study design and baseline data, 548 PATIENT COMPLIANCE Screening for Auditory Impairment — Which Hearing Assessment Test (SAI-WHAT): RCT design and baseline characteristics, 303 PATIENT OUTCOME ASSESSMENT Screening for Auditory Impairment — Which Hearing Assessment Test (SAI-WHAT): RCT design and baseline characteristics, 303 PATIENT PREFERENCES Decision-making and breast cancer clinical trials: How experience challenges attitudes, 684 PATIENT SATISFACTION PRODIACOR: A patient-centered treatment program for type 2 diabetes and associated cardiovascular risk factors in the city of Corrientes, Argentina: Study design and baseline data, 548 PATIENT SELECTION The challenge of recruiting patients with anterior cruciate ligament injury of the knee into a randomized clinical trial comparing surgical and non-surgical treatment, 295 PATIENTS Creating a culture of research, 557

PHARMACOKINETIC–PHARMACODYNAMIC MODEL A kinetic-pharmacodynamic model for clinical trialsimulation of antidepressant action: Application to clomipramine–lithium interaction, 276 PHASE 1 Prevalence of abnormal liver-associated enzymes in cocaine experienced adults versus healthy volunteers during Phase 1 clinical trials, 695 PHASE 2 A unicenter, randomized, double-blind, parallelgroup, placebo-controlled study of Melatonin as an Adjunct in patients with acute myocaRdial Infarction undergoing primary Angioplasty: The Melatonin Adjunct in the acute MyocaRdial Infarction treated with Angioplasty (MARIA) trial: Study design and rationale, 532 PHASE 2 TRIALS An adaptive Simon Two-Stage Design for Phase 2 studies of targeted therapies, 654 PHASE I Cognitive testing in early-phase clinical trials: Development of a rapid computerized test battery and application in a simulated Phase I study, 391 PHASE II Phase II multi-step planning methods in oncology: Comparison, recommendations and potential applications, 249 PHASE II CLINICAL TRIAL Alternative designs of phase II trials considering response and toxicity, 525

PEDIATRIC A rationale and method for high-intensity progressive resistance training with children and adolescents, 442

PHASE II CLINICAL TRIALS An adaptive approach for bivariate phase II clinical trial designs, 482 Methods of joint evaluation of efficacy and toxicity in phase II clinical trials, 514

PELVIC FLOOR MUSCLE EXERCISES Design of the Behavior Enhances Drug Reduction of Incontinence (BE-DRI) study, 48

PHASE II TRIAL DESIGN Improving the design of phase II trials of cytostatic anticancer agents, 138

PERMUTATION TEST A permutation test for a weighted Kaplan–Meier estimator with application to the nutritional prevention of cancer trial, 343

PHASE II TRIALS Optimizing randomized phase II trials assessing tumor progression, 146

PERSONAL AUTONOMY Decision-making and breast cancer clinical trials: How experience challenges attitudes, 684

PHYSICAL ACTIVITY Effects of an exercise intervention on other health behaviors in overweight/obese post-menopausal women, 472

Subject Index for Volume 28

Step into Motion: A randomized trial examining the relative efficacy of Internet vs. print-based physical activity interventions, 737 Randomized controlled trials of positive affect and self-affirmation to facilitate healthy behaviors in patients with cardiopulmonary diseases: Rationale, trial design, and methods, 748

795

PREVENTION TRIALS Design and analysis of stepped wedge cluster randomized trials, 182

PHYSICIAN DECISION SUPPORT Assessing Physicians’ Use of Treatment Algorithms: Project IMPACTS Study Design and Rationale, 192

PRIMARY ANGIOPLASTY A unicenter, randomized, double-blind, parallelgroup, placebo-controlled study of Melatonin as an Adjunct in patients with acute myocaRdial Infarction undergoing primary Angioplasty: The Melatonin Adjunct in the acute MyocaRdial Infarction treated with Angioplasty (MARIA) trial: Study design and rationale, 532

POSITIVE AFFECT Randomized controlled trials of positive affect and self-affirmation to facilitate healthy behaviors in patients with cardiopulmonary diseases: Rationale, trial design, and methods, 748

PRIMARY CARE Recruitment issues when primary care population clusters are used in randomised controlled clinical trials: Climbing mountains or pushing boulders uphill?, 232

POST-MENOPAUSAL WOMEN Effects of an exercise intervention on other health behaviors in overweight/obese post-menopausal women, 472

PRIMARY PREVENTION A rationale and method for high-intensity progressive resistance training with children and adolescents, 442

POWER A permutation test for a weighted Kaplan–Meier estimator with application to the nutritional prevention of cancer trial, 343 Testing homogeneity of the risk ratio in stratified noncompliance randomized trials, 614

PROPORTIONAL HAZARDS A permutation test for a weighted Kaplan–Meier estimator with application to the nutritional prevention of cancer trial, 343

PRACTICE-BASED RESEARCH Value of recruitment strategies used in a primary care practice-based trial, 258 PRACTICE-BASED RESEARCH NETWORK (PBRN) The medication Adherence and Blood Pressure Control (ABC) trial: A multi-site randomized controlled trial in a hypertensive, multi-cultural, economically disadvantaged population, 459 PREDICTION Predicting where future means will lie based on the results of the current trial, 352 PREDICTORS Predictors of attendance and dropout at the Lung Health Study 11-year follow-up, 25 PRESENTATION Presentation in relation to publication of results from clinical trials, 358 PRESENTATION AND PUBLICATION POLICY Presentation in relation to publication of results from clinical trials, 358

PROSTATE Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of AvodartR and Tamsulosin) trial rationale and study design, 770 PROSTATE CANCER Costs of recruiting couples to a clinical trial, 423 Delay in the progression of low-risk prostate cancer: Rationale and design of the Reduction by Dutasteride of Clinical Progression Events in Expectant Management (REDEEM) trial, 763 PROSTATE ENLARGEMENT COMBINATION DRUG THERAPY Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of AvodartR and Tamsulosin) trial rationale and study design, 770 PROSTATE-SPECIFIC ANTIGEN Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of AvodartR and Tamsulosin) trial rationale and study design, 770

796

Subject Index for Volume 28

PROSTATIC HYPERPLASIA Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of AvodartR and Tamsulosin) trial rationale and study design, 770 PSYCHOLOGICAL IMPACT PRODIACOR: A patient-centered treatment program for type 2 diabetes and associated cardiovascular risk factors in the city of Corrientes, Argentina: Study design and baseline data, 548 PUBLIC HEALTH Recruitment issues when primary care population clusters are used in randomised controlled clinical trials: Climbing mountains or pushing boulders uphill?, 232 PUBLIC PARTICIPATION Creating a culture of research, 557 PUBLICATION Presentation in relation to publication of results from clinical trials, 358 QUALITATIVE METHODS Recruitment issues when primary care population clusters are used in randomised controlled clinical trials: Climbing mountains or pushing boulders uphill?, 232 QUALITATIVE RESEARCH Involving communities in the design of clinical trial protocols: The BAN Study in Lilongwe, Malawi, 59 QUALITY OF CARE PRODIACOR: A patient-centered treatment program for type 2 diabetes and associated cardiovascular risk factors in the city of Corrientes, Argentina: Study design and baseline data, 548 QUALITY OF LIFE Design of the Behavior Enhances Drug Reduction of Incontinence (BE-DRI) study, 48 Screening for Auditory Impairment– Which Hearing Assessment Test (SAI-WHAT): RCT design and baseline characteristics, 303 A randomized trial of PET scanning to improve diagnostic yield of direct laryngoscopy in patients with suspicion of recurrent laryngeal carcinoma after radiotherapy, 705

RADIOTHERAPY A randomized trial of PET scanning to improve diagnostic yield of direct laryngoscopy in patients with suspicion of recurrent laryngeal carcinoma after radiotherapy, 705 RANDOM EFFECTS MODEL Random-effects model for meta-analysis of clinical trials: An update, 105 RANDOMISED CONTROLLED TRIALS Decision-making and breast cancer clinical trials: How experience challenges attitudes, 684 RANDOMISED TRIAL A randomised trial of the effects of an additional communication strategy on recruitment into a large-scale, multi-centre trial, 1 RANDOMIZATION Optimizing randomized phase II trials assessing tumor progression, 146 RANDOMIZED CLINICAL TRIAL Design of a stage-matched intervention trial to increase dual method contraceptive use (Project PROTECT), 626 Randomized controlled trials of positive affect and self-affirmation to facilitate healthy behaviors in patients with cardiopulmonary diseases: Rationale, trial design, and methods, 748 RANDOMIZED CLINICAL TRIAL DESIGN The Best Bypass Surgery Trial: Rationale and design of a randomized clinical trial with blinded outcome assessment of conventional versus off-pump coronary artery bypass grafting, 540 RANDOMIZED CONTROLLED TRIAL A rationale and method for high-intensity progressive resistance training with children and adolescents, 442 Lack of correlation between satisfaction and knowledge in clinical trials participants: A pilot study, 730 RANDOMIZED CONTROLLED TRIALS The challenge of recruiting patients with anterior cruciate ligament injury of the knee into a randomized clinical trial comparing surgical and non-surgical treatment, 295 Screening for Auditory Impairment — Which Hearing Assessment Test (SAI-WHAT): RCT design and baseline characteristics, 303 Rationale, design, and methods for the risk evaluation and communication health outcomes and utilization trial (REACH OUT), 662

Subject Index for Volume 28

RANDOMIZED PLAY-THE-WINNER Power and sample size simulations for Randomized Play-the-Winner rules, 487 RANDOMIZED TRIAL Improving the design of phase II trials of cytostatic anticancer agents, 138 An RCT of the effect of motivational interviewing on medication adherence in hypertensive African Americans: Rationale and design, 169 The medication Adherence and Blood Pressure Control (ABC) trial: A multi-site randomized controlled trial in a hypertensive, multi-cultural, economically disadvantaged population, 459 RANDOMIZED TRIALS Epidemiology and reporting of randomized trials employing re-randomization of patient groups: A systematic survey, 268 RECRUITMENT A randomised trial of the effects of an additional communication strategy on recruitment into a large-scale, multi-centre trial, 1 A perspective on African American participation in clinical trials, 213 Recruitment issues when primary care population clusters are used in randomised controlled clinical trials: Climbing mountains or pushing boulders uphill?, 232 Value of recruitment strategies used in a primary care practice-based trial, 258 Costs of recruiting couples to a clinical trial, 423 Patient recruitment into a randomised controlled trial of supervised exercise therapy in sedentary women treated for breast cancer, 603 RECRUITMENT STRATEGIES Costs of recruiting couples to a clinical trial, 423 RECURRENCE A randomized trial of PET scanning to improve diagnostic yield of direct laryngoscopy in patients with suspicion of recurrent laryngeal carcinoma after radiotherapy, 705 5a-REDUCTASE INHIBITOR Delay in the progression of low-risk prostate cancer: Rationale and design of the Reduction by Dutasteride of Clinical Progression Events in Expectant Management (REDEEM) trial, 763 REHABILITATION The challenge of recruiting patients with anterior cruciate ligament injury of the knee into a randomized clinical trial comparing surgical and non-surgical treatment, 295

797

REHABILITATION OF HEARING IMPAIRED Screening for Auditory Impairment — Which Hearing Assessment Test (SAI-WHAT): RCT design and baseline characteristics, 303 RELATIVE EFFICIENCY A matched crossover design for clinical trials, 638 RELATIVE RISK Interval estimation of risk ratio in the simple compliance randomized trial, 120 REPEATED MEASURES Including multiple imputation in a sensitivity analysis for clinical trials with treatment failures, 130 Randomized clinical trials with a pre- and a posttreatment measurement: Repeated measures versus ANCOVA models, 713 RE-RANDOMIZATION Epidemiology and reporting of randomized trials employing re-randomization of patient groups: A systematic survey, 268 RESEARCH ETHICS COMMITTEE Industry-sponsored research in developing countries, 677 RESEARCH METHODOLOGY Randomized controlled trials of positive affect and self-affirmation to facilitate healthy behaviors in patients with cardiopulmonary diseases: Rationale, trial design, and methods, 748 RESPONSE-ADAPTIVE RANDOMIZATION Power and sample size simulations for Randomized Play-the-Winner rules, 487 RESPONSE RATE Phase II multi-step planning methods in oncology: Comparison, recommendations and potential applications, 249 RESPONSE RATES Clinical trials and the response rate illusion, 348 Randomized clinical trials with a pre- and a posttreatment measurement: Repeated measures versus ANCOVA models, 713 RESTRICTED MAXIMUM LIKELIHOOD Random-effects model for meta-analysis of clinical trials: An update, 105 Randomized clinical trials with a pre- and a post– treatment measurement: Repeated measures versus ANCOVA models, 713 RETENTION Factors associated with early study discontinuation in AACTG studies, DACS 200, 583

798

Subject Index for Volume 28

RETENTION IN CLINICAL TRIALS Factors associated with loss to follow-up in a large tuberculosis treatment trial (TBTC Study 22), 288 RETINAL PHOTOGRAPHY Rationale and design of the AdRem study: Evaluating the effects of blood pressure lowering and intensive glucose control on vascular retinal disorders in patients with type 2 diabetes mellitus, 6 RETINAL VASCULAR GEOMETRY Rationale and design of the AdRem study: Evaluating the effects of blood pressure lowering and intensive glucose control on vascular retinal disorders in patients with type 2 diabetes mellitus, 6 RETINOPATHY Rationale and design of the AdRem study: Evaluating the effects of blood pressure lowering and intensive glucose control on vascular retinal disorders in patients with type 2 diabetes mellitus, 6 REVIEW BODY Industry-sponsored research in developing countries, 677 RISK ASSESSMENT Rationale, design, and methods for the risk evaluation and communication health outcomes and utilization trial (REACH OUT), 662 RISK RATIO Testing homogeneity of the risk ratio in stratified noncompliance randomized trials, 614 RISK REDUCTION COUNSELING Starting from scratch: Program development and lessons learned from HIV vaccine trial counseling in Thailand, 409 1RM A rationale and method for high-intensity progressive resistance training with children and adolescents, 442 ROBUST Alternative designs of phase II trials considering response and toxicity, 525 SAMPLE SIZE The challenge of recruiting patients with anterior cruciate ligament injury of the knee into a randomized clinical trial comparing surgical and non-surgical treatment, 295 Sample size calculation for multicenter randomized trial: Taking the center effect into account, 451

Power and sample size simulations for Randomized Play-the-Winner rules, 487 Group sequential t-test for clinical trials with small sample sizes across stages, 563 SAMPLE SIZE CALCULATION Design, statistical analysis and sample size calculation of dose response study of telmisartan and hydrochlorothiazide, 647 SAMPLE SIZE RECALCULATION An adaptive approach for bivariate phase II clinical trial designs, 482 SCREENING Screening for Auditory Impairment— Which Hearing Assessment Test (SAI-WHAT): RCT design and baseline characteristics, 303 SELENIUM A permutation test for a weighted Kaplan–Meier estimator with application to the nutritional prevention of cancer trial, 343 SELF-MANAGEMENT The Take Control of Your Blood pressure (TCYB) study: Study design and methodology, 33 SENSITIVITY Optimizing randomized phase II trials assessing tumor progression, 146 SEXUALLY TRANSMITTED DISEASE Design of a stage-matched intervention trial to increase dual method contraceptive use (Project PROTECT), 626 SIMON TWO-STAGE An adaptive Simon Two-Stage Design for Phase 2 studies of targeted therapies, 654 SIMPLE COMPLIANCE STUDY Interval estimation of risk ratio in the simple compliance randomized trial, 120 SIMULATION Group sequential t-test for clinical trials with small sample sizes across stages, 563 SMOKING CESSATION Predictors of attendance and dropout at the Lung Health Study 11-year follow-up, 25 SOCIAL COGNITIVE THEORY Step into Motion: A randomized trial examining the relative efficacy of Internet vs. print-based physical activity interventions, 737

Subject Index for Volume 28

SOCIAL CONTEXT Creating a culture of research, 557 SOFTWARE INSTALLATION Implementation of electronic data capture systems: Barriers and solutions, 329 STD Design of a stage-matched intervention trial to increase dual method contraceptive use (Project PROTECT), 626 STEPPED WEDGE DESIGN Design and analysis of stepped wedge cluster randomized trials, 182 STOPPING PROBABILITY Phase II multi-step planning methods in oncology: Comparison, recommendations and potential applications, 249 STRENGTH A rationale and method for high-intensity progressive resistance training with children and adolescents, 442 STUDY DESIGN A unicenter, randomized, double-blind, parallelgroup, placebo-controlled study of Melatonin as an Adjunct in patients with acute myocaRdial Infarction undergoing primary Angioplasty: The Melatonin Adjunct in the acute MyocaRdial Infarction treated with Angioplasty (MARIA) trial: Study design and rationale, 532 STUDY POWER The effect of omitted covariates on confidence interval and study power in binary outcome analysis: A simulation study, 242 SUBCLINICAL DISEASE The clinical trial of Women On the Move through Activity and Nutrition (WOMAN) study, 370 SUBJECT ATTRITION Predictors of attendance and dropout at the Lung Health Study 11-year follow-up, 25 SURGICAL LIGAMENT RECONSTRUCTION The challenge of recruiting patients with anterior cruciate ligament injury of the knee into a randomized clinical trial comparing surgical and non-surgical treatment, 295 SYNERGY Comparison of antitumor activities in tumor xenograft treatment, 115

799

SYSTEMATIC REVIEW Epidemiology and reporting of randomized trials employing re-randomization of patient groups: A systematic survey, 268 TARGETED THERAPY An adaptive Simon Two-Stage Design for Phase 2 studies of targeted therapies, 654 TECHNICAL SUPPORT Implementation of electronic data capture systems: Barriers and solutions, 329 TELEMONITORING The medication Adherence and Blood Pressure Control (ABC) trial: A multi-site randomized controlled trial in a hypertensive, multi-cultural, economically disadvantaged population, 459 TELEPHONE Examination of print and telephone channels for physical activity promotion: Rationale, design, and baseline data from Project STRIDE, 90 TELEPHONE SURVEY Lessons and pitfalls of interactive voice response in medical research, 593 TELMISARTAN Design, statistical analysis and sample size calculation of dose response study of telmisartan and hydrochlorothiazide, 647 TESTOSTERONE Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of AvodartR and Tamsulosin) trial rationale and study design, 770 THAILAND Starting from scratch: Program development and lessons learned from HIV vaccine trial counseling in Thailand, 409 TIMING OF IMPLEMENTATION Implementation of electronic data capture systems: Barriers and solutions, 329 TRAINING Design paper: The DEMO trial: A randomized, parallel-group, observer-blinded clinical trial of aerobic versus non-aerobic versus relaxation training for patients with light to moderate depression, 79

800

Subject Index for Volume 28

TRANSTHEORETICAL MODEL Step into Motion: A randomized trial examining the relative efficacy of Internet vs. print-based physical activity interventions, 737 TREATMENT ALGORITHMS Assessing Physicians’ Use of Treatment Algorithms: Project IMPACTS Study Design and Rationale, 192 TREATMENT EFFECT ESTIMATION Randomized clinical trials with a pre- and a posttreatment measurement: Repeated measures versus ANCOVA models, 713 TREATMENT EFFECTIVENESS Screening for Auditory Impairment— Which Hearing Assessment Test (SAI-WHAT): RCT design and baseline characteristics, 303 TRIAL DESIGN Cluster-crossover design: A method for limiting clusters level effect in community-intervention studies, 316 TRIAL PARTICIPATION Decision-making and breast cancer clinical trials: How experience challenges attitudes, 684 TRIANGULAR TEST Phase II multi-step planning methods in oncology: Comparison, recommendations and potential applications, 249 T-STATISTIC Group sequential t-test for clinical trials with small sample sizes across stages, 563 TUBERCULOSIS Factors associated with loss to follow-up in a large tuberculosis treatment trial (TBTC Study 22), 288 TUMOR GROWTH Endpoints for agents that slow tumor growth, 18 TUMOR XENOGRAFT MODELS Comparison of antitumor activities in tumor xenograft treatment, 115 TWO-STAGE DESIGN Alternative designs of phase II trials considering response and toxicity, 525

TYPE 2 DIABETES MANAGEMENT PRODIACOR: A patient-centered treatment program for type 2 diabetes and associated cardiovascular risk factors in the city of Corrientes, Argentina: Study design and baseline data, 548 TYPE I ERROR Alternative designs of phase II trials considering response and toxicity, 525 Testing homogeneity of the risk ratio in stratified noncompliance randomized trials, 614 TYPE I ERROR RATE Group sequential t-test for clinical trials with small sample sizes across stages, 563 UNDERSERVED The medication Adherence and Blood Pressure Control (ABC) trial: A multi-site randomized controlled trial in a hypertensive, multi-cultural, economically disadvantaged population, 459 UNINTENDED PREGNANCY Design of a stage-matched intervention trial to increase dual method contraceptive use (Project PROTECT), 626 URINARY INCONTINENCE Design of the Behavior Enhances Drug Reduction of Incontinence (BE-DRI) study, 48 USER INPUT Implementation of electronic data capture systems: Barriers and solutions, 329 USER MOTIVATION Implementation of electronic data capture systems: Barriers and solutions, 329 VARIANCE COMPONENTS Random-effects model for meta-analysis of clinical trials: An update, 105 VETERANS Characteristics associated with participation in DNA banking: The National Registry of Veterans with ALS, 572 WATCHFUL WAITING Delay in the progression of low-risk prostate cancer: Rationale and design of the Reduction by Dutasteride of Clinical Progression Events in Expectant Management (REDEEM) trial, 763

Subject Index for Volume 28

WEIGHT TRAINING A rationale and method for high-intensity progressive resistance training with children and adolescents, 442

WEIGHTED KAPLAN–MEIER A permutation test for a weighted Kaplan–Meier estimator with application to the nutritional prevention of cancer trial, 343

801

WOMEN The clinical trial of Women On the Move through Activity and Nutrition (WOMAN) study, 370 WORK Design paper: The DEMO trial: A randomized, parallel-group, observer-blinded clinical trial of aerobic versus non-aerobic versus relaxation training for patients with light to moderate depression, 79