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Subject Index for Volume 27
Subject Index for Volume 27 ADHERENCE Ancillary study to the PREFER trial: A descriptive study of participants’ patterns of self-monitoring — rationale, design and preliminary experiences, 23 PREFER study: A randomized clinical trial testing treatment preference and two dietary options in behavioral weight management — rationale, design and baseline characteristics, 34 ADULT EDUCATION A pragmatic 2 2 2 factorial cluster randomized controlled trial of educational outreach visiting and case conferencing in palliative care— methodology of the Palliative Care Trial [ISRCTN 81117481], 83 ADVERSE EVENT RATES Respiratory adverse event profiles in cystic fibrosis placebo subjects in short- and long-term inhaled therapy trials, 561 ADVERSE EVENTS Experience using MedDRA for global events coding in HIV clinical trials, 13 Systematic identification and classification of adverse events in human research, 295 AFRICAN AMERICANS African Americans and participation in clinical trials: Differences in beliefs and attitudes by gender, 498 AGING Recruitment of the elderly into a pharmacologic prevention trial: The Ginkgo Evaluation of Memory Study experience, 541 ALLERGIC DISEASE Intestinal microbiota and its effect on the immune system — A nested case-cohort study on prevention of atopy among small children in Trondheim: The IMPACT study, 389 doi:10.1016/S1551-7144(06)00134-0
ALLHAT Prescribing patterns for thiazide diuretics in a large health maintenance organization: Relationship to participation as an ALLHAT clinical center, 397 ALZHEIMER’S DISEASE The Ginkgo Evaluation of Memory (GEM) study: Design and baseline data of a randomized trial of Ginkgo biloba extract in prevention of dementia, 238 Recruitment of the elderly into a pharmacologic prevention trial: The Ginkgo Evaluation of Memory Study experience, 541 ANALGESICS Enriched analgesic efficacy studies: An assessment by clinical trial simulation, 165 ANALYTIC METHODS Analysis strategies for a community trial to reduce adolescent ATOD use: A comparison of random coefficient and ANOVA/ANCOVA models, 188 ANTICOAGULANT The challenges of new drugs benefits and risks analysis: Lessons from the ximelagatran FDA Cardiovascular Advisory Committee, 432 ANTIHYPERTENSIVE AGENT Prescribing patterns for thiazide diuretics in a large health maintenance organization: Relationship to participation as an ALLHAT clinical center, 397 ATOPY Intestinal microbiota and its effect on the immune system — A nested case-cohort study on prevention of atopy among small children in Trondheim: The IMPACT study, 389 AUDIT Validation of complex interventions in a low back pain trial: Selective video analysis crossreferenced to clinical case notes, 404
Subject Index for Volume 27
591
BACKGROUND RATES Respiratory adverse event profiles in cystic fibrosis placebo subjects in short- and long-term inhaled therapy trials, 561
CERVIX UTERI Trial of management of borderline and other lowgrade abnormal smears (TOMBOLA): Trial design, 449
BARRIERS African Americans and participation in clinical trials: Differences in beliefs and attitudes by gender, 498
CHILDREN Intestinal microbiota and its effect on the immune system — A nested case-cohort study on prevention of atopy among small children in Trondheim: The IMPACT study, 389
BEHAVIORAL INTERVENTION Understanding African-American participation in a behavioral intervention: Results from focus groups, 274 BENEFIT The challenges of new drugs benefits and risks analysis: Lessons from the ximelagatran FDA Cardiovascular Advisory Committee, 432 BIAS Comparison of two or more measurement techniques to a standard, 472 Robust analysis of biomarker data with informative missingness using a two-stage hypothesis test in an HIV treatment interruption trial: AIEDRP AIN503/ACTG A5217, 506 BIVARIATE NORMAL OUTCOMES A likelihood approach to analyzing clinical trial data when treatments favor different outcomes, 340 BLAND–ALTMAN PLOT Comparison of two or more measurement techniques to a standard, 472 BODY IMAGE Total laparoscopic versus open surgery for stage 1 endometrial cancer: The LACE randomized controlled trial, 353 CARDIOVASCULAR DISEASE Rationale and design of the TRANSFACT project phase I: A study to assess the effect of the two different dietary sources of trans fatty acids on cardiovascular risk factors in humans, 364
CHINESE HERBS MEDICINE Assessing the quality of RCTs on the effect of h-elemene, one ingredient of a Chinese herb, against malignant tumors, 70 CHRONIC DISEASE Recruitment to a trial of self-care skills training in long-term health conditions: Analysis of the impact of patient attitudes and preferences, 49 CHRONIC OBSTRUCTIVE PULMONARY DISEASE The Reconditioning Exercise and Chronic Obstructive Pulmonary Disease Trial II (REACT II): Rationale and study design for a clinical trial of physical activity among individuals with chronic obstructive pulmonary disease, 135 CLASSIFICATION OF DEATH Comparing classifications of death in the Mode Selection Trial: Agreement and disagreement among site investigators and a clinical events committee, 260 CLINICAL EVENTS COMMITTEES Comparing classifications of death in the Mode Selection Trial: Agreement and disagreement among site investigators and a clinical events committee, 260 CLINICAL INTERVENTIONS Validation of complex interventions in a low back pain trial: Selective video analysis crossreferenced to clinical case notes, 404
CAUSE OF DEATH Value of an Endpoints Committee versus the use of nosologists for validating cause of death, 333
CLINICAL PHARMACOLOGY Study design and rationale of a mock phase I trial as an educational tool for clinical pharmacology residents, 183
CERVICAL SCREENING Trial of management of borderline and other lowgrade abnormal smears (TOMBOLA): Trial design, 449
CLINICAL SITE Center for clinical studies in a surgical department— An approach for more evidence-based medicine, 211
592
Subject Index for Volume 27
CLINICAL TRIAL Recruitment of the elderly into a pharmacologic prevention trial: The Ginkgo Evaluation of Memory Study experience, 541 CLINICAL TRIALS Experience using MedDRA for global events coding in HIV clinical trials, 13 Factors motivating dyspepsia patients to enter clinical research, 103 Informatics tools to improve clinical research study implementation, 112 Protecting human subjects in neurosurgical trials: The challenge of psychogenic dystonia, 161 Enriched analgesic efficacy studies: An assessment by clinical trial simulation, 165 Study design and rationale of a mock phase I trial as an educational tool for clinical pharmacology residents, 183 A reduced frequency visit schedule underreports adverse events that resulted in dose modifications or treatment discontinuations in HIV/ AIDS clinical trials: ACTG DACS 207, 287 A likelihood approach to analyzing clinical trial data when treatments favor different outcomes, 340 The challenges of new drugs benefits and risks analysis: Lessons from the ximelagatran FDA Cardiovascular Advisory Committee, 432 Long term clinical trials: How much information do participants retain from the informed consent process?, 441 African Americans and participation in clinical trials: Differences in beliefs and attitudes by gender, 498 Respiratory adverse event profiles in cystic fibrosis placebo subjects in short- and long-term inhaled therapy trials, 561 CLINICAL TRIALS METHODOLOGY A pragmatic 2 2 2 factorial cluster randomized controlled trial of educational outreach visiting and case conferencing in palliative care— methodology of the Palliative Care Trial [ISRCTN 81117481], 83 11
C-META-HYDROXYEPHEDRINE Prediction of Arrhythmic Events with Positron Emission Tomography: PAREPET study design and methods, 374
COGNITIVE–BEHAVIORAL INTERVENTIONS The Reconditioning Exercise and Chronic Obstructive Pulmonary Disease Trial II (REACT II): Rationale and study design for a clinical trial of physical activity among individuals with chronic obstructive pulmonary disease, 135 COLPOSCOPY Trial of management of borderline and other lowgrade abnormal smears (TOMBOLA): Trial design, 449 CONTINUOUS PROGNOSTIC VARIABLE Minimization method for balancing continuous prognostic variables between treatment and control groups using Kullback-Leibler divergence, 420 CONTROLLED CLINICAL TRIALS Center for clinical studies in a surgical department— An approach for more evidence-based medicine, 211 CORRELATION PLACEBO AND TREATMENT EFFECT Enriched analgesic efficacy studies: An assessment by clinical trial simulation, 165 COST FUNCTION Optimal number of repeated measures and group sizes in clinical trials with linearly divergent treatment effects, 57 COST-EFFECTIVENESS The Cost–Time Index: A new method for measuring the efficiencies of recruitment-resources in clinical trials, 494 COST–TIME INDEX The Cost–Time Index: A new method for measuring the efficiencies of recruitment-resources in clinical trials, 494 CURVE COMPARISON A new method of evaluating antitumor activity from measured tumor volumes, 269 CYSTIC FIBROSIS Respiratory adverse event profiles in cystic fibrosis placebo subjects in short- and long-term inhaled therapy trials, 561
Subject Index for Volume 27
593
CYTOLOGICAL SURVEILLANCE Trial of management of borderline and other lowgrade abnormal smears (TOMBOLA): Trial design, 449
DISPARITIES Long term clinical trials: How much information do participants retain from the informed consent process?, 441
DATA MANAGEMENT Quality assurance in a large clinical trials consortium: The experience of the Tuberculosis Trials Consortium, 554
DIURETICS Prescribing patterns for thiazide diuretics in a large health maintenance organization: Relationship to participation as an ALLHAT clinical center, 397
DATA QUALITY ASSURANCE Quality assurance in a large clinical trials consortium: The experience of the Tuberculosis Trials Consortium, 554 DATA SAFETY MONITORING BOARD Respiratory adverse event profiles in cystic fibrosis placebo subjects in short- and long-term inhaled therapy trials, 561 DATABASE MANAGEMENT SYSTEM Informatics tools to improve clinical research study implementation, 112 DEMENTIA The Ginkgo Evaluation of Memory (GEM) study: Design and baseline data of a randomized trial of Ginkgo biloba extract in prevention of dementia, 238 Recruitment of the elderly into a pharmacologic prevention trial: The Ginkgo Evaluation of Memory Study experience, 541 DESIGN Study design and rationale of a mock phase I trial as an educational tool for clinical pharmacology residents, 183 DETECTION LIMIT A general approach for sample size and statistical power calculations assessing the effects of interventions using a mixture model in the presence of detection limits, 483 DIABETES MELLITUS Minimization method for balancing continuous prognostic variables between treatment and control groups using Kullback-Leibler divergence, 420 DIET Heart positive: Design of a randomized controlled clinical trial of intensive lifestyle intervention, niacin and fenofibrate for HIV lipodystrophy/ dyslipidemia, 518
DRUG APPROVAL The challenges of new drugs benefits and risks analysis: Lessons from the ximelagatran FDA Cardiovascular Advisory Committee, 432 DRUG TOXICITIES A reduced frequency visit schedule underreports adverse events that resulted in dose modifications or treatment discontinuations in HIV/ AIDS clinical trials: ACTG DACS 207, 287 EATING AND PHYSICAL ACTIVITY BEHAVIORS Ancillary study to the PREFER trial: A descriptive study of participants’ patterns of self-monitoring — rationale, design and preliminary experiences, 23 EDOMETRIAL CANCER Total laparoscopic versus open surgery for stage 1 endometrial cancer: The LACE randomized controlled trial, 353 ELDERLY Recruitment of the elderly into a pharmacologic prevention trial: The Ginkgo Evaluation of Memory Study experience, 541 ELEMENE INJECTIONS Assessing the quality of RCTs on the effect of h-elemene, one ingredient of a Chinese herb, against malignant tumors, 70 ENDPOINT ADJUDICATION Comparing classifications of death in the Mode Selection Trial: Agreement and disagreement among site investigators and a clinical events committee, 260 ENDPOINTS COMMITTEE Value of an Endpoints Committee versus the use of nosologists for validating cause of death, 333 ENRICHMENT Enriched analgesic efficacy studies: An assessment by clinical trial simulation, 165
594
Subject Index for Volume 27
EPIDEMIOLOGICAL METHODS Value of an Endpoints Committee versus the use of nosologists for validating cause of death, 333 ETHICS Protecting human subjects in neurosurgical trials: The challenge of psychogenic dystonia, 161 EVALUATION OF QUALITY Assessing the quality of RCTs on the effect of helemene, one ingredient of a Chinese herb, against malignant tumors, 70 EVIDENCE-BASED MEDICINE Center for clinical studies in a surgical department— An approach for more evidence-based medicine, 211 EXERCISE Heart positive: Design of a randomized controlled clinical trial of intensive lifestyle intervention, niacin and fenofibrate for HIV lipodystrophy/ dyslipidemia, 518 A randomized comparative trial of the efficacy and safety of exercise during pregnancy: Design and methods, 531 18
F-2-DEOXYGLUCOSE Prediction of Arrhythmic Events with Positron Emission Tomography: PAREPET study design and methods, 374 GENDER DIFFERENCES African Americans and participation in clinical trials: Differences in beliefs and attitudes by gender, 498 GENERALIZED LEAST SQUARES Optimal number of repeated measures and group sizes in clinical trials with linearly divergent treatment effects, 57
GINKGO BILOBA The Ginkgo Evaluation of Memory (GEM) study: Design and baseline data of a randomized trial of Ginkgo biloba extract in prevention of dementia, 238 Recruitment of the elderly into a pharmacologic prevention trial: The Ginkgo Evaluation of Memory Study experience, 541 GROUP SIZES Optimal number of repeated measures and group sizes in clinical trials with linearly divergent treatment effects, 57
GROUP-RANDOMIZED TRIAL Analysis strategies for a community trial to reduce adolescent ATOD use: A comparison of random coefficient and ANOVA/ANCOVA models, 188 GUT MICROBIOTA Intestinal microbiota and its effect on the immune system — A nested case-cohort study on prevention of atopy among small children in Trondheim: The IMPACT study, 389 HEALTH CARE COST Total laparoscopic versus open surgery for stage 1 endometrial cancer: The LACE randomized controlled trial, 353 HEALTH SERVICES RESEARCH A pragmatic 2 2 2 factorial cluster randomized controlled trial of educational outreach visiting and case conferencing in palliative care— methodology of the Palliative Care Trial [ISRCTN 81117481], 83 HEART FAILURE INTERVENTIONS Understanding African-American participation in a behavioral intervention: Results from focus groups, 274 HEPATIC TOXICITY The challenges of new drugs benefits and risks analysis: Lessons from the ximelagatran FDA Cardiovascular Advisory Committee, 432 HIBERNATING MYOCARDIUM Prediction of Arrhythmic Events with Positron Emission Tomography: PAREPET study design and methods, 374 HIV LIPODYSTROPHY Heart positive: Design of a randomized controlled clinical trial of intensive lifestyle intervention, niacin and fenofibrate for HIV lipodystrophy/ dyslipidemia, 518 HIV TREATMENT INTERRUPTION TRIAL Robust analysis of biomarker data with informative missingness using a two-stage hypothesis test in an HIV treatment interruption trial: AIEDRP AIN503/ACTG A5217, 506 HIV VACCINE Statistical evaluation of HIV vaccines in early clinical trials, 147
Subject Index for Volume 27
595
HIV-INFECTION Heart positive: Design of a randomized controlled clinical trial of intensive lifestyle intervention, niacin and fenofibrate for HIV lipodystrophy/ dyslipidemia, 518
INSULIN RESISTANCE Heart positive: Design of a randomized controlled clinical trial of intensive lifestyle intervention, niacin and fenofibrate for HIV lipodystrophy/ dyslipidemia, 518
HYPERLIPIDEMIA Minimization method for balancing continuous prognostic variables between treatment and control groups using Kullback-Leibler divergence, 420
INVESTIGATORS’ ATTITUDES Investigators’ assessment of NIH mandated inclusion of women and minorities in research, 571
IMMUNE SYSTEM Intestinal microbiota and its effect on the immune system — A nested case-cohort study on prevention of atopy among small children in Trondheim: The IMPACT study, 389 INFORMATICS Informatics tools to improve clinical research study implementation, 112 INFORMATIVE DROPOUT A new method of evaluating antitumor activity from measured tumor volumes, 269 INFORMED CONSENT Randomized consent designs in randomized controlled trials: Systematic literature search, 320 Long term clinical trials: How much information do participants retain from the informed consent process?, 441 INHALED THERAPIES Respiratory adverse event profiles in cystic fibrosis placebo subjects in short- and long-term inhaled therapy trials, 561 INSTITUTIONAL REVIEW BOARD Regulatory challenges: Lessons from recent West Nile virus trials in the United States, 254 INSTITUTIONAL REVIEW BOARDS Systematic identification and classification of adverse events in human research, 295 INSTRUMENTED PAPER DIARIES (IPD) Ancillary study to the PREFER trial: A descriptive study of participants’ patterns of selfmonitoring — rationale, design and preliminary experiences, 23
IRRITABLE BOWEL SYNDROME Investigating placebo effects in irritable bowel syndrome: A novel research design, 123 KNEE OSTEOARTHRITIS Determinants of high and low attendance to diet and exercise interventions among overweight and obese older adults: Results from the arthritis, diet, and activity promotion trial, 227 KULLBACK-LEIBLER DIVERGENCE Minimization method for balancing continuous prognostic variables between treatment and control groups using Kullback-Leibler divergence, 420 LACTO-OVO-VEGETARIAN DIET PREFER study: A randomized clinical trial testing treatment preference and two dietary options in behavioral weight management — rationale, design and baseline characteristics, 34 LAPAROSCOPIC SURGERY Total laparoscopic versus open surgery for stage 1 endometrial cancer: The LACE randomized controlled trial, 353 LINEAR DIVERGENCE Optimal number of repeated measures and group sizes in clinical trials with linearly divergent treatment effects, 57 LIPID-LOWERING DRUGS Heart positive: Design of a randomized controlled clinical trial of intensive lifestyle intervention, niacin and fenofibrate for HIV lipodystrophy/ dyslipidemia, 518 LONG-TERM HEALTH CONDITION Recruitment to a trial of self-care skills training in long-term health conditions: Analysis of the impact of patient attitudes and preferences, 49
596
Subject Index for Volume 27
LOWEST LEVEL TERM Experience using MedDRA for global events coding in HIV clinical trials, 13
MINORITY POPULATIONS Investigator beliefs and reported success in recruiting minority participants, 580
LOW-GRADE ABNORMALITIES Trial of management of borderline and other lowgrade abnormal smears (TOMBOLA): Trial design, 449
MINORITY RECRUITMENT Investigators’ assessment of NIH mandated inclusion of women and minorities in research, 571
MANAGEMENT Trial of management of borderline and other lowgrade abnormal smears (TOMBOLA): Trial design, 449
MISSING DATA Robust analysis of biomarker data with informative missingness using a two-stage hypothesis test in an HIV treatment interruption trial: AIEDRP AIN503/ACTG A5217, 506
MEASUREMENT ERROR Comparison of two or more measurement techniques to a standard, 472 MEDDRA Experience using MedDRA for global events coding in HIV clinical trials, 13
MIXTURE MODELS A general approach for sample size and statistical power calculations assessing the effects of interventions using a mixture model in the presence of detection limits, 483
MEDICATION ADHERENCE Adherence to calcium/vitamin D and estrogen protocols among diverse older participants enrolled in a clinical trial, 215
MOCK TRIAL Study design and rationale of a mock phase I trial as an educational tool for clinical pharmacology residents, 183
MENTAL HEALTH Adherence to calcium/vitamin D and estrogen protocols among diverse older participants enrolled in a clinical trial, 215
MODE SELECTION TRIAL Comparing classifications of death in the Mode Selection Trial: Agreement and disagreement among site investigators and a clinical events committee, 260
METHODS Review of randomised trials using the post-randomised consent (Zelen’s) design, 305 MILD DYSKARYOSIS Trial of management of borderline and other lowgrade abnormal smears (TOMBOLA): Trial design, 449 MILK FAT Rationale and design of the TRANSFACT project phase I: A study to assess the effect of the two different dietary sources of trans fatty acids on cardiovascular risk factors in humans, 364 MINIMIZATION METHOD Minimization method for balancing continuous prognostic variables between treatment and control groups using Kullback-Leibler divergence, 420 MINORITY PARTICIPATION IN CLINICAL TRIALS Understanding African-American participation in a behavioral intervention: Results from focus groups, 274
MONITORING Quality assurance in a large clinical trials consortium: The experience of the Tuberculosis Trials Consortium, 554 MOST Comparing classifications of death in the Mode Selection Trial: Agreement and disagreement among site investigators and a clinical events committee, 260 MOTIVATING FACTORS Factors motivating dyspepsia patients to enter clinical research, 103 MOTIVATION African Americans and participation in clinical trials: Differences in beliefs and attitudes by gender, 498 MULTICENTER CLINICAL TRIALS Quality assurance in a large clinical trials consortium: The experience of the Tuberculosis Trials Consortium, 554
Subject Index for Volume 27
MULTIPLE OUTCOMES A likelihood approach to analyzing clinical trial data when treatments favor different outcomes, 340 13
N-AMMONIA Prediction of Arrhythmic Events with Positron Emission Tomography: PAREPET study design and methods, 374 NESTED CASE-COHORT STUDY Intestinal microbiota and its effect on the immune system — A nested case-cohort study on prevention of atopy among small children in Trondheim: The IMPACT study, 389 NEUROSURGICAL RESEARCH Protecting human subjects in neurosurgical trials: The challenge of psychogenic dystonia, 161 NIH REVITALIZATION ACT Investigators’ assessment of NIH mandated inclusion of women and minorities in research, 571 NONPARAMETRIC METHODS Comparison of survival times in a transplant study of hematologic disorders, 174 NOSOLOGISTS Value of an Endpoints Committee versus the use of nosologists for validating cause of death, 333 NUMBER OF REPEATED MEASURES Optimal number of repeated measures and group sizes in clinical trials with linearly divergent treatment effects, 57
OBESITY Ancillary study to the PREFER trial: A descriptive study of participants’ patterns of self-monitoring — rationale, design and preliminary experiences, 23 PREFER study: A randomized clinical trial testing treatment preference and two dietary options in behavioral weight management — rationale, design and baseline characteristics, 34 Determinants of high and low attendance to diet and exercise interventions among overweight and obese older adults: Results from the arthritis, diet, and activity promotion trial, 227
597
OLDER ADULTS The Reconditioning Exercise and Chronic Obstructive Pulmonary Disease Trial II (REACT II): Rationale and study design for a clinical trial of physical activity among individuals with chronic obstructive pulmonary disease, 135 OXIDATIVE STRESS A randomized comparative trial of the efficacy and safety of exercise during pregnancy: Design and methods, 531 PAIN Total laparoscopic versus open surgery for stage 1 endometrial cancer: The LACE randomized controlled trial, 353 PAIN MANAGEMENT A pragmatic 2 2 2 factorial cluster randomized controlled trial of educational outreach visiting and case conferencing in palliative care— methodology of the Palliative Care Trial [ISRCTN 81117481], 83 PALLIATIVE CARE A pragmatic 2 2 2 factorial cluster randomized controlled trial of educational outreach visiting and case conferencing in palliative care— methodology of the Palliative Care Trial [ISRCTN 81117481], 83 PATIENT ADHERENCE Determinants of high and low attendance to diet and exercise interventions among overweight and obese older adults: Results from the arthritis, diet, and activity promotion trial, 227 PATIENT PERCEPTIONS Recruitment to a trial of self-care skills training in long-term health conditions: Analysis of the impact of patient attitudes and preferences, 49 PATIENT PREFERENCES Recruitment to a trial of self-care skills training in long-term health conditions: Analysis of the impact of patient attitudes and preferences, 49 PATIENT RETENTION Understanding African-American participation in a behavioral intervention: Results from focus groups, 274
598
Subject Index for Volume 27
PATIENT TREATMENT PREFERENCES A comparison of socio-demographic and psychological factors between patients consenting to randomisation and those selecting treatment (the ProtecT study), 413 PATIENT–PRACTITIONER RELATIONSHIP Investigating placebo effects in irritable bowel syndrome: A novel research design, 123 PATIENTS Factors motivating dyspepsia patients to enter clinical research, 103 PHASE I Study design and rationale of a mock phase I trial as an educational tool for clinical pharmacology residents, 183 PHASE III CLINICAL TRIAL Total laparoscopic versus open surgery for stage 1 endometrial cancer: The LACE randomized controlled trial, 353 PHASE I/II CLINICAL TRIALS Statistical evaluation of HIV vaccines in early clinical trials, 147 PHYSICAL ACTIVITY The Reconditioning Exercise and Chronic Obstructive Pulmonary Disease Trial II (REACT II): Rationale and study design for a clinical trial of physical activity among individuals with chronic obstructive pulmonary disease, 135 A randomized comparative trial of the efficacy and safety of exercise during pregnancy: Design and methods, 531 PHYSIOTHERAPY Validation of complex interventions in a low back pain trial: Selective video analysis crossreferenced to clinical case notes, 404 PLACEBO EFFECT Investigating placebo effects in irritable bowel syndrome: A novel research design, 123 PLACEBO RUN-IN Investigating placebo effects in irritable bowel syndrome: A novel research design, 123 PLACEBO SUBJECTS Respiratory adverse event profiles in cystic fibrosis placebo subjects in short- and long-term inhaled therapy trials, 561
POISSON MODELS Respiratory adverse event profiles in cystic fibrosis placebo subjects in short- and long-term inhaled therapy trials, 561 POISSON REGRESSION A reduced frequency visit schedule underreports adverse events that resulted in dose modifications or treatment discontinuations in HIV/ AIDS clinical trials: ACTG DACS 207, 287 POSITRON EMISSION TOMOGRAPHY Prediction of Arrhythmic Events with Positron Emission Tomography: PAREPET study design and methods, 374 POWER Statistical evaluation of HIV vaccines in early clinical trials, 147 Analysis strategies for a community trial to reduce adolescent ATOD use: A comparison of random coefficient and ANOVA/ANCOVA models, 188 PREECLAMPSIA A randomized comparative trial of the efficacy and safety of exercise during pregnancy: Design and methods, 531 PREFERRED TERM Experience using MedDRA for global events coding in HIV clinical trials, 13 PREGNANT A randomized comparative trial of the efficacy and safety of exercise during pregnancy: Design and methods, 531 PRE-RANDOMIZATION Randomized consent designs in randomized controlled trials: Systematic literature search, 320 PRESCRIPTION Prescribing patterns for thiazide diuretics in a large health maintenance organization: Relationship to participation as an ALLHAT clinical center, 397 PRIMARY PREVENTION TRIAL The Ginkgo Evaluation of Memory (GEM) study: Design and baseline data of a randomized trial of Ginkgo biloba extract in prevention of dementia, 238
Subject Index for Volume 27
599
PRINCIPAL INVESTIGATORS Investigator beliefs and reported success in recruiting minority participants, 580
RANDOMISED CONTROLLED TRIALS The use of unequal randomisation ratios in clinical trials: A review, 1
PROSTATE CANCER A comparison of socio-demographic and psychological factors between patients consenting to randomisation and those selecting treatment (the ProtecT study), 413
RANDOMISED-CONTROLLED TRIAL Trial of management of borderline and other lowgrade abnormal smears (TOMBOLA): Trial design, 449
PROTOCOL DEVELOPMENT Regulatory challenges: Lessons from recent West Nile virus trials in the United States, 254 PSYCHOGENIC DYSTONIA Protecting human subjects in neurosurgical trials: The challenge of psychogenic dystonia, 161 PUBLIC HEALTH NUTRITION Rationale and design of the TRANSFACT project phase I: A study to assess the effect of the two different dietary sources of trans fatty acids on cardiovascular risk factors in humans, 364 QUALITATIVE METHODS Investigating placebo effects in irritable bowel syndrome: A novel research design, 123 QUALITY ASSURANCE Quality assurance in a large clinical trials consortium: The experience of the Tuberculosis Trials Consortium, 554 QUALITY OF LIFE Total laparoscopic versus open surgery for stage 1 endometrial cancer: The LACE randomized controlled trial, 353
RANDOMIZED CLINICAL TRIAL PREFER study: A randomized clinical trial testing treatment preference and two dietary options in behavioral weight management — rationale, design and baseline characteristics, 34 Investigating placebo effects in irritable bowel syndrome: A novel research design, 123 RANDOMIZED CONSENT DESIGN Randomized consent designs in randomized controlled trials: Systematic literature search, 320 RANDOMIZED PLACEBO-CONTROLLED CLINICAL TRIAL A randomized comparative trial of the efficacy and safety of exercise during pregnancy: Desig2n and methods, 531 RCTS Assessing the quality of RCTs on the effect of h-elemene, one ingredient of a Chinese herb, against malignant tumors, 70 RECALL OF INFORMATION Long term clinical trials: How much information do participants retain from the informed consent process?, 441
RANDOMISED CONSENT Review of randomised trials using the post-randomised consent (Zelen’s) design, 305
RECOVERY Total laparoscopic versus open surgery for stage 1 endometrial cancer: The LACE randomized controlled trial, 353
RANDOMISED CONTROLLED TRIAL Recruitment to a trial of self-care skills training in long-term health conditions: Analysis of the impact of patient attitudes and preferences, 49 A comparison of socio-demographic and psychological factors between patients consenting to randomisation and those selecting treatment (the ProtecT study), 413
RECRUITMENT Recruitment to a trial of self-care skills training in long-term health conditions: Analysis of the impact of patient attitudes and preferences, 49 Factors motivating dyspepsia patients to enter clinical research, 103 The Cost–Time Index: A new method for measuring the efficiencies of recruitment-resources in clinical trials, 494
600
Subject Index for Volume 27
Recruitment of the elderly into a pharmacologic prevention trial: The Ginkgo Evaluation of Memory Study experience, 541 Investigator beliefs and reported success in recruiting minority participants, 580
ROBUST ANALYSIS Robust analysis of biomarker data with informative missingness using a two-stage hypothesis test in an HIV treatment interruption trial: AIEDRP AIN503/ACTG A5217, 506
RECRUITMENT EFFICIENCY The Cost–Time Index: A new method for measuring the efficiencies of recruitment-resources in clinical trials, 494
SAFETY MONITORING Respiratory adverse event profiles in cystic fibrosis placebo subjects in short- and long-term inhaled therapy trials, 561
RESEARCH DESIGN Ancillary study to the PREFER trial: A descriptive study of participants’ patterns of self-monitoring — rationale, design and preliminary experiences, 23 PREFER study: A randomized clinical trial testing treatment preference and two dietary options in behavioral weight management — rationale, design and baseline characteristics, 34
SAMPLE SIZE A general approach for sample size and statistical power calculations assessing the effects of interventions using a mixture model in the presence of detection limits, 483
RESEARCH METHODOLOGY Investigating placebo effects in irritable bowel syndrome: A novel research design, 123 RESEARCH PARTICIPATION African Americans and participation in clinical trials: Differences in beliefs and attitudes by gender, 498 RESPIRATORY ADVERSE EVENTS Respiratory adverse event profiles in cystic fibrosis placebo subjects in short- and long-term inhaled therapy trials, 561 RETENTION OF INFORMATION Long term clinical trials: How much information do participants retain from the informed consent process?, 441
SELF-CARE Recruitment to a trial of self-care skills training in long-term health conditions: Analysis of the impact of patient attitudes and preferences, 49 SELF-MONITORING Ancillary study to the PREFER trial: A descriptive study of participants’ patterns of selfmonitoring — rationale, design and preliminary experiences, 23 SELF-REPORT Ancillary study to the PREFER trial: A descriptive study of participants’ patterns of self-monitoring — rationale, design and preliminary experiences, 23 SENSITIVITY Value of an Endpoints Committee versus the use of nosologists for validating cause of death, 333
REVIEW Review of randomised trials using the post-randomised consent (Zelen’s) design, 305
SES Adherence to calcium/vitamin D and estrogen protocols among diverse older participants enrolled in a clinical trial, 215
REVIEW RESEARCH ETHICS Randomized consent designs in randomized controlled trials: Systematic literature search, 320
SIMULATION Enriched analgesic efficacy studies: An assessment by clinical trial simulation, 165
RISK The challenges of new drugs benefits and risks analysis: Lessons from the ximelagatran FDA Cardiovascular Advisory Committee, 432
SOMATIC COMPLAINTS Adherence to calcium/vitamin D and estrogen protocols among diverse older participants enrolled in a clinical trial, 215
Subject Index for Volume 27
SPECIFICITY Value of an Endpoints Committee versus the use of nosologists for validating cause of death, 333 STANDARD BEHAVIORAL TREATMENT OF OBESITY Ancillary study to the PREFER trial: A descriptive study of participants’ patterns of self-monitoring — rationale, design and preliminary experiences, 23 PREFER study: A randomized clinical trial testing treatment preference and two dietary options in behavioral weight management — rationale, design and baseline characteristics, 34 STATISTICAL POWER A general approach for sample size and statistical power calculations assessing the effects of interventions using a mixture model in the presence of detection limits, 483 STEM CELL Comparison of survival times in a transplant study of hematologic disorders, 174 STUDY COORDINATION Informatics tools to improve clinical research study implementation, 112 SUDDEN CARDIAC DEATH Prediction of Arrhythmic Events with Positron Emission Tomography: PAREPET study design and methods, 374 SURGERY Center for clinical studies in a surgical department— An approach for more evidence-based medicine, 211 SURROGATE ENDPOINT Robust analysis of biomarker data with informative missingness using a two-stage hypothesis test in an HIV treatment interruption trial: AIEDRP AIN503/ACTG A5217, 506 SYMPATHETIC NERVES Prediction of Arrhythmic Events with Positron Emission Tomography: PAREPET study design and methods, 374 SYSTEMATIC LITERATURE SEARCH Randomized consent designs in randomized controlled trials: Systematic literature search, 320
601
TRAINING Study design and rationale of a mock phase I trial as an educational tool for clinical pharmacology residents, 183 TRANS FATTY ACID Rationale and design of the TRANSFACT project phase I: A study to assess the effect of the two different dietary sources of trans fatty acids on cardiovascular risk factors in humans, 364 TRANSPLANT Comparison of survival times in a transplant study of hematologic disorders, 174 TREATMENT PREFERENCE PREFER study: A randomized clinical trial testing treatment preference and two dietary options in behavioral weight management — rationale, design and baseline characteristics, 34 TREATMENT TRIAL Validation of complex interventions in a low back pain trial: Selective video analysis crossreferenced to clinical case notes, 404 TRIAL DESIGN Statistical evaluation of HIV vaccines in early clinical trials, 147 The challenges of new drugs benefits and risks analysis: Lessons from the ximelagatran FDA Cardiovascular Advisory Committee, 432 TRIAL PARTICIPATION Recruitment to a trial of self-care skills training in long-term health conditions: Analysis of the impact of patient attitudes and preferences, 49 A comparison of socio-demographic and psychological factors between patients consenting to randomisation and those selecting treatment (the ProtecT study), 413 TUMOR RESPONSE A new method of evaluating antitumor activity from measured tumor volumes, 269 TUMOR XENOGRAFT MODELS A new method of evaluating antitumor activity from measured tumor volumes, 269 TWO ARMED TRIAL Minimization method for balancing continuous prognostic variables between treatment and control groups using Kullback-Leibler divergence, 420
602
Subject Index for Volume 27
TWO-FACTOR ANALYSIS PREFER study: A randomized clinical trial testing treatment preference and two dietary options in behavioral weight management — rationale, design and baseline characteristics, 34
VISIT SCHEDULE A reduced frequency visit schedule underreports adverse events that resulted in dose modifications or treatment discontinuations in HIV/ AIDS clinical trials: ACTG DACS 207, 287
UNEQUAL RANDOMISATION The use of unequal randomisation ratios in clinical trials: A review, 1
WEST NILE VIRUS Regulatory challenges: Lessons from recent West Nile virus trials in the United States, 254
URVIVAL ANALYSIS Comparison of survival times in a transplant study of hematologic disorders, 174
XIMELAGATRAN The challenges of new drugs benefits and risks analysis: Lessons from the ximelagatran FDA Cardiovascular Advisory Committee, 432
VIABLE MYOCARDIUM Prediction of Arrhythmic Events with Positron Emission Tomography: PAREPET study design and methods, 374
ZELEN DESIGN Randomized consent designs in randomized controlled trials: Systematic literature search, 320
VIDEO ANALYSIS Validation of complex interventions in a low back pain trial: Selective video analysis crossreferenced to clinical case notes, 404
ZELEN’S METHOD Review of randomised trials using the post-randomised consent (Zelen’s) design, 305
ALLHAT Prescribing patterns for thiazide diuretics in a large health maintenance organization: Relationship to participation as an ALLHAT clinical center, 397 ALZHEIMER’S DISEASE The Ginkgo Evaluation of Memory (GEM) study: Design and baseline data of a randomized trial of Ginkgo biloba extract in prevention of dementia, 238 Recruitment of the elderly into a pharmacologic prevention trial: The Ginkgo Evaluation of Memory Study experience, 541 ANALGESICS Enriched analgesic efficacy studies: An assessment by clinical trial simulation, 165 ANALYTIC METHODS Analysis strategies for a community trial to reduce adolescent ATOD use: A comparison of random coefficient and ANOVA/ANCOVA models, 188 ANTICOAGULANT The challenges of new drugs benefits and risks analysis: Lessons from the ximelagatran FDA Cardiovascular Advisory Committee, 432 ANTIHYPERTENSIVE AGENT Prescribing patterns for thiazide diuretics in a large health maintenance organization: Relationship to participation as an ALLHAT clinical center, 397 ATOPY Intestinal microbiota and its effect on the immune system — A nested case-cohort study on prevention of atopy among small children in Trondheim: The IMPACT study, 389 AUDIT Validation of complex interventions in a low back pain trial: Selective video analysis crossreferenced to clinical case notes, 404
Subject Index for Volume 27
591
BACKGROUND RATES Respiratory adverse event profiles in cystic fibrosis placebo subjects in short- and long-term inhaled therapy trials, 561
CERVIX UTERI Trial of management of borderline and other lowgrade abnormal smears (TOMBOLA): Trial design, 449
BARRIERS African Americans and participation in clinical trials: Differences in beliefs and attitudes by gender, 498
CHILDREN Intestinal microbiota and its effect on the immune system — A nested case-cohort study on prevention of atopy among small children in Trondheim: The IMPACT study, 389
BEHAVIORAL INTERVENTION Understanding African-American participation in a behavioral intervention: Results from focus groups, 274 BENEFIT The challenges of new drugs benefits and risks analysis: Lessons from the ximelagatran FDA Cardiovascular Advisory Committee, 432 BIAS Comparison of two or more measurement techniques to a standard, 472 Robust analysis of biomarker data with informative missingness using a two-stage hypothesis test in an HIV treatment interruption trial: AIEDRP AIN503/ACTG A5217, 506 BIVARIATE NORMAL OUTCOMES A likelihood approach to analyzing clinical trial data when treatments favor different outcomes, 340 BLAND–ALTMAN PLOT Comparison of two or more measurement techniques to a standard, 472 BODY IMAGE Total laparoscopic versus open surgery for stage 1 endometrial cancer: The LACE randomized controlled trial, 353 CARDIOVASCULAR DISEASE Rationale and design of the TRANSFACT project phase I: A study to assess the effect of the two different dietary sources of trans fatty acids on cardiovascular risk factors in humans, 364
CHINESE HERBS MEDICINE Assessing the quality of RCTs on the effect of h-elemene, one ingredient of a Chinese herb, against malignant tumors, 70 CHRONIC DISEASE Recruitment to a trial of self-care skills training in long-term health conditions: Analysis of the impact of patient attitudes and preferences, 49 CHRONIC OBSTRUCTIVE PULMONARY DISEASE The Reconditioning Exercise and Chronic Obstructive Pulmonary Disease Trial II (REACT II): Rationale and study design for a clinical trial of physical activity among individuals with chronic obstructive pulmonary disease, 135 CLASSIFICATION OF DEATH Comparing classifications of death in the Mode Selection Trial: Agreement and disagreement among site investigators and a clinical events committee, 260 CLINICAL EVENTS COMMITTEES Comparing classifications of death in the Mode Selection Trial: Agreement and disagreement among site investigators and a clinical events committee, 260 CLINICAL INTERVENTIONS Validation of complex interventions in a low back pain trial: Selective video analysis crossreferenced to clinical case notes, 404
CAUSE OF DEATH Value of an Endpoints Committee versus the use of nosologists for validating cause of death, 333
CLINICAL PHARMACOLOGY Study design and rationale of a mock phase I trial as an educational tool for clinical pharmacology residents, 183
CERVICAL SCREENING Trial of management of borderline and other lowgrade abnormal smears (TOMBOLA): Trial design, 449
CLINICAL SITE Center for clinical studies in a surgical department— An approach for more evidence-based medicine, 211
592
Subject Index for Volume 27
CLINICAL TRIAL Recruitment of the elderly into a pharmacologic prevention trial: The Ginkgo Evaluation of Memory Study experience, 541 CLINICAL TRIALS Experience using MedDRA for global events coding in HIV clinical trials, 13 Factors motivating dyspepsia patients to enter clinical research, 103 Informatics tools to improve clinical research study implementation, 112 Protecting human subjects in neurosurgical trials: The challenge of psychogenic dystonia, 161 Enriched analgesic efficacy studies: An assessment by clinical trial simulation, 165 Study design and rationale of a mock phase I trial as an educational tool for clinical pharmacology residents, 183 A reduced frequency visit schedule underreports adverse events that resulted in dose modifications or treatment discontinuations in HIV/ AIDS clinical trials: ACTG DACS 207, 287 A likelihood approach to analyzing clinical trial data when treatments favor different outcomes, 340 The challenges of new drugs benefits and risks analysis: Lessons from the ximelagatran FDA Cardiovascular Advisory Committee, 432 Long term clinical trials: How much information do participants retain from the informed consent process?, 441 African Americans and participation in clinical trials: Differences in beliefs and attitudes by gender, 498 Respiratory adverse event profiles in cystic fibrosis placebo subjects in short- and long-term inhaled therapy trials, 561 CLINICAL TRIALS METHODOLOGY A pragmatic 2 2 2 factorial cluster randomized controlled trial of educational outreach visiting and case conferencing in palliative care— methodology of the Palliative Care Trial [ISRCTN 81117481], 83 11
C-META-HYDROXYEPHEDRINE Prediction of Arrhythmic Events with Positron Emission Tomography: PAREPET study design and methods, 374
COGNITIVE–BEHAVIORAL INTERVENTIONS The Reconditioning Exercise and Chronic Obstructive Pulmonary Disease Trial II (REACT II): Rationale and study design for a clinical trial of physical activity among individuals with chronic obstructive pulmonary disease, 135 COLPOSCOPY Trial of management of borderline and other lowgrade abnormal smears (TOMBOLA): Trial design, 449 CONTINUOUS PROGNOSTIC VARIABLE Minimization method for balancing continuous prognostic variables between treatment and control groups using Kullback-Leibler divergence, 420 CONTROLLED CLINICAL TRIALS Center for clinical studies in a surgical department— An approach for more evidence-based medicine, 211 CORRELATION PLACEBO AND TREATMENT EFFECT Enriched analgesic efficacy studies: An assessment by clinical trial simulation, 165 COST FUNCTION Optimal number of repeated measures and group sizes in clinical trials with linearly divergent treatment effects, 57 COST-EFFECTIVENESS The Cost–Time Index: A new method for measuring the efficiencies of recruitment-resources in clinical trials, 494 COST–TIME INDEX The Cost–Time Index: A new method for measuring the efficiencies of recruitment-resources in clinical trials, 494 CURVE COMPARISON A new method of evaluating antitumor activity from measured tumor volumes, 269 CYSTIC FIBROSIS Respiratory adverse event profiles in cystic fibrosis placebo subjects in short- and long-term inhaled therapy trials, 561
Subject Index for Volume 27
593
CYTOLOGICAL SURVEILLANCE Trial of management of borderline and other lowgrade abnormal smears (TOMBOLA): Trial design, 449
DISPARITIES Long term clinical trials: How much information do participants retain from the informed consent process?, 441
DATA MANAGEMENT Quality assurance in a large clinical trials consortium: The experience of the Tuberculosis Trials Consortium, 554
DIURETICS Prescribing patterns for thiazide diuretics in a large health maintenance organization: Relationship to participation as an ALLHAT clinical center, 397
DATA QUALITY ASSURANCE Quality assurance in a large clinical trials consortium: The experience of the Tuberculosis Trials Consortium, 554 DATA SAFETY MONITORING BOARD Respiratory adverse event profiles in cystic fibrosis placebo subjects in short- and long-term inhaled therapy trials, 561 DATABASE MANAGEMENT SYSTEM Informatics tools to improve clinical research study implementation, 112 DEMENTIA The Ginkgo Evaluation of Memory (GEM) study: Design and baseline data of a randomized trial of Ginkgo biloba extract in prevention of dementia, 238 Recruitment of the elderly into a pharmacologic prevention trial: The Ginkgo Evaluation of Memory Study experience, 541 DESIGN Study design and rationale of a mock phase I trial as an educational tool for clinical pharmacology residents, 183 DETECTION LIMIT A general approach for sample size and statistical power calculations assessing the effects of interventions using a mixture model in the presence of detection limits, 483 DIABETES MELLITUS Minimization method for balancing continuous prognostic variables between treatment and control groups using Kullback-Leibler divergence, 420 DIET Heart positive: Design of a randomized controlled clinical trial of intensive lifestyle intervention, niacin and fenofibrate for HIV lipodystrophy/ dyslipidemia, 518
DRUG APPROVAL The challenges of new drugs benefits and risks analysis: Lessons from the ximelagatran FDA Cardiovascular Advisory Committee, 432 DRUG TOXICITIES A reduced frequency visit schedule underreports adverse events that resulted in dose modifications or treatment discontinuations in HIV/ AIDS clinical trials: ACTG DACS 207, 287 EATING AND PHYSICAL ACTIVITY BEHAVIORS Ancillary study to the PREFER trial: A descriptive study of participants’ patterns of self-monitoring — rationale, design and preliminary experiences, 23 EDOMETRIAL CANCER Total laparoscopic versus open surgery for stage 1 endometrial cancer: The LACE randomized controlled trial, 353 ELDERLY Recruitment of the elderly into a pharmacologic prevention trial: The Ginkgo Evaluation of Memory Study experience, 541 ELEMENE INJECTIONS Assessing the quality of RCTs on the effect of h-elemene, one ingredient of a Chinese herb, against malignant tumors, 70 ENDPOINT ADJUDICATION Comparing classifications of death in the Mode Selection Trial: Agreement and disagreement among site investigators and a clinical events committee, 260 ENDPOINTS COMMITTEE Value of an Endpoints Committee versus the use of nosologists for validating cause of death, 333 ENRICHMENT Enriched analgesic efficacy studies: An assessment by clinical trial simulation, 165
594
Subject Index for Volume 27
EPIDEMIOLOGICAL METHODS Value of an Endpoints Committee versus the use of nosologists for validating cause of death, 333 ETHICS Protecting human subjects in neurosurgical trials: The challenge of psychogenic dystonia, 161 EVALUATION OF QUALITY Assessing the quality of RCTs on the effect of helemene, one ingredient of a Chinese herb, against malignant tumors, 70 EVIDENCE-BASED MEDICINE Center for clinical studies in a surgical department— An approach for more evidence-based medicine, 211 EXERCISE Heart positive: Design of a randomized controlled clinical trial of intensive lifestyle intervention, niacin and fenofibrate for HIV lipodystrophy/ dyslipidemia, 518 A randomized comparative trial of the efficacy and safety of exercise during pregnancy: Design and methods, 531 18
F-2-DEOXYGLUCOSE Prediction of Arrhythmic Events with Positron Emission Tomography: PAREPET study design and methods, 374 GENDER DIFFERENCES African Americans and participation in clinical trials: Differences in beliefs and attitudes by gender, 498 GENERALIZED LEAST SQUARES Optimal number of repeated measures and group sizes in clinical trials with linearly divergent treatment effects, 57
GINKGO BILOBA The Ginkgo Evaluation of Memory (GEM) study: Design and baseline data of a randomized trial of Ginkgo biloba extract in prevention of dementia, 238 Recruitment of the elderly into a pharmacologic prevention trial: The Ginkgo Evaluation of Memory Study experience, 541 GROUP SIZES Optimal number of repeated measures and group sizes in clinical trials with linearly divergent treatment effects, 57
GROUP-RANDOMIZED TRIAL Analysis strategies for a community trial to reduce adolescent ATOD use: A comparison of random coefficient and ANOVA/ANCOVA models, 188 GUT MICROBIOTA Intestinal microbiota and its effect on the immune system — A nested case-cohort study on prevention of atopy among small children in Trondheim: The IMPACT study, 389 HEALTH CARE COST Total laparoscopic versus open surgery for stage 1 endometrial cancer: The LACE randomized controlled trial, 353 HEALTH SERVICES RESEARCH A pragmatic 2 2 2 factorial cluster randomized controlled trial of educational outreach visiting and case conferencing in palliative care— methodology of the Palliative Care Trial [ISRCTN 81117481], 83 HEART FAILURE INTERVENTIONS Understanding African-American participation in a behavioral intervention: Results from focus groups, 274 HEPATIC TOXICITY The challenges of new drugs benefits and risks analysis: Lessons from the ximelagatran FDA Cardiovascular Advisory Committee, 432 HIBERNATING MYOCARDIUM Prediction of Arrhythmic Events with Positron Emission Tomography: PAREPET study design and methods, 374 HIV LIPODYSTROPHY Heart positive: Design of a randomized controlled clinical trial of intensive lifestyle intervention, niacin and fenofibrate for HIV lipodystrophy/ dyslipidemia, 518 HIV TREATMENT INTERRUPTION TRIAL Robust analysis of biomarker data with informative missingness using a two-stage hypothesis test in an HIV treatment interruption trial: AIEDRP AIN503/ACTG A5217, 506 HIV VACCINE Statistical evaluation of HIV vaccines in early clinical trials, 147
Subject Index for Volume 27
595
HIV-INFECTION Heart positive: Design of a randomized controlled clinical trial of intensive lifestyle intervention, niacin and fenofibrate for HIV lipodystrophy/ dyslipidemia, 518
INSULIN RESISTANCE Heart positive: Design of a randomized controlled clinical trial of intensive lifestyle intervention, niacin and fenofibrate for HIV lipodystrophy/ dyslipidemia, 518
HYPERLIPIDEMIA Minimization method for balancing continuous prognostic variables between treatment and control groups using Kullback-Leibler divergence, 420
INVESTIGATORS’ ATTITUDES Investigators’ assessment of NIH mandated inclusion of women and minorities in research, 571
IMMUNE SYSTEM Intestinal microbiota and its effect on the immune system — A nested case-cohort study on prevention of atopy among small children in Trondheim: The IMPACT study, 389 INFORMATICS Informatics tools to improve clinical research study implementation, 112 INFORMATIVE DROPOUT A new method of evaluating antitumor activity from measured tumor volumes, 269 INFORMED CONSENT Randomized consent designs in randomized controlled trials: Systematic literature search, 320 Long term clinical trials: How much information do participants retain from the informed consent process?, 441 INHALED THERAPIES Respiratory adverse event profiles in cystic fibrosis placebo subjects in short- and long-term inhaled therapy trials, 561 INSTITUTIONAL REVIEW BOARD Regulatory challenges: Lessons from recent West Nile virus trials in the United States, 254 INSTITUTIONAL REVIEW BOARDS Systematic identification and classification of adverse events in human research, 295 INSTRUMENTED PAPER DIARIES (IPD) Ancillary study to the PREFER trial: A descriptive study of participants’ patterns of selfmonitoring — rationale, design and preliminary experiences, 23
IRRITABLE BOWEL SYNDROME Investigating placebo effects in irritable bowel syndrome: A novel research design, 123 KNEE OSTEOARTHRITIS Determinants of high and low attendance to diet and exercise interventions among overweight and obese older adults: Results from the arthritis, diet, and activity promotion trial, 227 KULLBACK-LEIBLER DIVERGENCE Minimization method for balancing continuous prognostic variables between treatment and control groups using Kullback-Leibler divergence, 420 LACTO-OVO-VEGETARIAN DIET PREFER study: A randomized clinical trial testing treatment preference and two dietary options in behavioral weight management — rationale, design and baseline characteristics, 34 LAPAROSCOPIC SURGERY Total laparoscopic versus open surgery for stage 1 endometrial cancer: The LACE randomized controlled trial, 353 LINEAR DIVERGENCE Optimal number of repeated measures and group sizes in clinical trials with linearly divergent treatment effects, 57 LIPID-LOWERING DRUGS Heart positive: Design of a randomized controlled clinical trial of intensive lifestyle intervention, niacin and fenofibrate for HIV lipodystrophy/ dyslipidemia, 518 LONG-TERM HEALTH CONDITION Recruitment to a trial of self-care skills training in long-term health conditions: Analysis of the impact of patient attitudes and preferences, 49
596
Subject Index for Volume 27
LOWEST LEVEL TERM Experience using MedDRA for global events coding in HIV clinical trials, 13
MINORITY POPULATIONS Investigator beliefs and reported success in recruiting minority participants, 580
LOW-GRADE ABNORMALITIES Trial of management of borderline and other lowgrade abnormal smears (TOMBOLA): Trial design, 449
MINORITY RECRUITMENT Investigators’ assessment of NIH mandated inclusion of women and minorities in research, 571
MANAGEMENT Trial of management of borderline and other lowgrade abnormal smears (TOMBOLA): Trial design, 449
MISSING DATA Robust analysis of biomarker data with informative missingness using a two-stage hypothesis test in an HIV treatment interruption trial: AIEDRP AIN503/ACTG A5217, 506
MEASUREMENT ERROR Comparison of two or more measurement techniques to a standard, 472 MEDDRA Experience using MedDRA for global events coding in HIV clinical trials, 13
MIXTURE MODELS A general approach for sample size and statistical power calculations assessing the effects of interventions using a mixture model in the presence of detection limits, 483
MEDICATION ADHERENCE Adherence to calcium/vitamin D and estrogen protocols among diverse older participants enrolled in a clinical trial, 215
MOCK TRIAL Study design and rationale of a mock phase I trial as an educational tool for clinical pharmacology residents, 183
MENTAL HEALTH Adherence to calcium/vitamin D and estrogen protocols among diverse older participants enrolled in a clinical trial, 215
MODE SELECTION TRIAL Comparing classifications of death in the Mode Selection Trial: Agreement and disagreement among site investigators and a clinical events committee, 260
METHODS Review of randomised trials using the post-randomised consent (Zelen’s) design, 305 MILD DYSKARYOSIS Trial of management of borderline and other lowgrade abnormal smears (TOMBOLA): Trial design, 449 MILK FAT Rationale and design of the TRANSFACT project phase I: A study to assess the effect of the two different dietary sources of trans fatty acids on cardiovascular risk factors in humans, 364 MINIMIZATION METHOD Minimization method for balancing continuous prognostic variables between treatment and control groups using Kullback-Leibler divergence, 420 MINORITY PARTICIPATION IN CLINICAL TRIALS Understanding African-American participation in a behavioral intervention: Results from focus groups, 274
MONITORING Quality assurance in a large clinical trials consortium: The experience of the Tuberculosis Trials Consortium, 554 MOST Comparing classifications of death in the Mode Selection Trial: Agreement and disagreement among site investigators and a clinical events committee, 260 MOTIVATING FACTORS Factors motivating dyspepsia patients to enter clinical research, 103 MOTIVATION African Americans and participation in clinical trials: Differences in beliefs and attitudes by gender, 498 MULTICENTER CLINICAL TRIALS Quality assurance in a large clinical trials consortium: The experience of the Tuberculosis Trials Consortium, 554
Subject Index for Volume 27
MULTIPLE OUTCOMES A likelihood approach to analyzing clinical trial data when treatments favor different outcomes, 340 13
N-AMMONIA Prediction of Arrhythmic Events with Positron Emission Tomography: PAREPET study design and methods, 374 NESTED CASE-COHORT STUDY Intestinal microbiota and its effect on the immune system — A nested case-cohort study on prevention of atopy among small children in Trondheim: The IMPACT study, 389 NEUROSURGICAL RESEARCH Protecting human subjects in neurosurgical trials: The challenge of psychogenic dystonia, 161 NIH REVITALIZATION ACT Investigators’ assessment of NIH mandated inclusion of women and minorities in research, 571 NONPARAMETRIC METHODS Comparison of survival times in a transplant study of hematologic disorders, 174 NOSOLOGISTS Value of an Endpoints Committee versus the use of nosologists for validating cause of death, 333 NUMBER OF REPEATED MEASURES Optimal number of repeated measures and group sizes in clinical trials with linearly divergent treatment effects, 57
OBESITY Ancillary study to the PREFER trial: A descriptive study of participants’ patterns of self-monitoring — rationale, design and preliminary experiences, 23 PREFER study: A randomized clinical trial testing treatment preference and two dietary options in behavioral weight management — rationale, design and baseline characteristics, 34 Determinants of high and low attendance to diet and exercise interventions among overweight and obese older adults: Results from the arthritis, diet, and activity promotion trial, 227
597
OLDER ADULTS The Reconditioning Exercise and Chronic Obstructive Pulmonary Disease Trial II (REACT II): Rationale and study design for a clinical trial of physical activity among individuals with chronic obstructive pulmonary disease, 135 OXIDATIVE STRESS A randomized comparative trial of the efficacy and safety of exercise during pregnancy: Design and methods, 531 PAIN Total laparoscopic versus open surgery for stage 1 endometrial cancer: The LACE randomized controlled trial, 353 PAIN MANAGEMENT A pragmatic 2 2 2 factorial cluster randomized controlled trial of educational outreach visiting and case conferencing in palliative care— methodology of the Palliative Care Trial [ISRCTN 81117481], 83 PALLIATIVE CARE A pragmatic 2 2 2 factorial cluster randomized controlled trial of educational outreach visiting and case conferencing in palliative care— methodology of the Palliative Care Trial [ISRCTN 81117481], 83 PATIENT ADHERENCE Determinants of high and low attendance to diet and exercise interventions among overweight and obese older adults: Results from the arthritis, diet, and activity promotion trial, 227 PATIENT PERCEPTIONS Recruitment to a trial of self-care skills training in long-term health conditions: Analysis of the impact of patient attitudes and preferences, 49 PATIENT PREFERENCES Recruitment to a trial of self-care skills training in long-term health conditions: Analysis of the impact of patient attitudes and preferences, 49 PATIENT RETENTION Understanding African-American participation in a behavioral intervention: Results from focus groups, 274
598
Subject Index for Volume 27
PATIENT TREATMENT PREFERENCES A comparison of socio-demographic and psychological factors between patients consenting to randomisation and those selecting treatment (the ProtecT study), 413 PATIENT–PRACTITIONER RELATIONSHIP Investigating placebo effects in irritable bowel syndrome: A novel research design, 123 PATIENTS Factors motivating dyspepsia patients to enter clinical research, 103 PHASE I Study design and rationale of a mock phase I trial as an educational tool for clinical pharmacology residents, 183 PHASE III CLINICAL TRIAL Total laparoscopic versus open surgery for stage 1 endometrial cancer: The LACE randomized controlled trial, 353 PHASE I/II CLINICAL TRIALS Statistical evaluation of HIV vaccines in early clinical trials, 147 PHYSICAL ACTIVITY The Reconditioning Exercise and Chronic Obstructive Pulmonary Disease Trial II (REACT II): Rationale and study design for a clinical trial of physical activity among individuals with chronic obstructive pulmonary disease, 135 A randomized comparative trial of the efficacy and safety of exercise during pregnancy: Design and methods, 531 PHYSIOTHERAPY Validation of complex interventions in a low back pain trial: Selective video analysis crossreferenced to clinical case notes, 404 PLACEBO EFFECT Investigating placebo effects in irritable bowel syndrome: A novel research design, 123 PLACEBO RUN-IN Investigating placebo effects in irritable bowel syndrome: A novel research design, 123 PLACEBO SUBJECTS Respiratory adverse event profiles in cystic fibrosis placebo subjects in short- and long-term inhaled therapy trials, 561
POISSON MODELS Respiratory adverse event profiles in cystic fibrosis placebo subjects in short- and long-term inhaled therapy trials, 561 POISSON REGRESSION A reduced frequency visit schedule underreports adverse events that resulted in dose modifications or treatment discontinuations in HIV/ AIDS clinical trials: ACTG DACS 207, 287 POSITRON EMISSION TOMOGRAPHY Prediction of Arrhythmic Events with Positron Emission Tomography: PAREPET study design and methods, 374 POWER Statistical evaluation of HIV vaccines in early clinical trials, 147 Analysis strategies for a community trial to reduce adolescent ATOD use: A comparison of random coefficient and ANOVA/ANCOVA models, 188 PREECLAMPSIA A randomized comparative trial of the efficacy and safety of exercise during pregnancy: Design and methods, 531 PREFERRED TERM Experience using MedDRA for global events coding in HIV clinical trials, 13 PREGNANT A randomized comparative trial of the efficacy and safety of exercise during pregnancy: Design and methods, 531 PRE-RANDOMIZATION Randomized consent designs in randomized controlled trials: Systematic literature search, 320 PRESCRIPTION Prescribing patterns for thiazide diuretics in a large health maintenance organization: Relationship to participation as an ALLHAT clinical center, 397 PRIMARY PREVENTION TRIAL The Ginkgo Evaluation of Memory (GEM) study: Design and baseline data of a randomized trial of Ginkgo biloba extract in prevention of dementia, 238
Subject Index for Volume 27
599
PRINCIPAL INVESTIGATORS Investigator beliefs and reported success in recruiting minority participants, 580
RANDOMISED CONTROLLED TRIALS The use of unequal randomisation ratios in clinical trials: A review, 1
PROSTATE CANCER A comparison of socio-demographic and psychological factors between patients consenting to randomisation and those selecting treatment (the ProtecT study), 413
RANDOMISED-CONTROLLED TRIAL Trial of management of borderline and other lowgrade abnormal smears (TOMBOLA): Trial design, 449
PROTOCOL DEVELOPMENT Regulatory challenges: Lessons from recent West Nile virus trials in the United States, 254 PSYCHOGENIC DYSTONIA Protecting human subjects in neurosurgical trials: The challenge of psychogenic dystonia, 161 PUBLIC HEALTH NUTRITION Rationale and design of the TRANSFACT project phase I: A study to assess the effect of the two different dietary sources of trans fatty acids on cardiovascular risk factors in humans, 364 QUALITATIVE METHODS Investigating placebo effects in irritable bowel syndrome: A novel research design, 123 QUALITY ASSURANCE Quality assurance in a large clinical trials consortium: The experience of the Tuberculosis Trials Consortium, 554 QUALITY OF LIFE Total laparoscopic versus open surgery for stage 1 endometrial cancer: The LACE randomized controlled trial, 353
RANDOMIZED CLINICAL TRIAL PREFER study: A randomized clinical trial testing treatment preference and two dietary options in behavioral weight management — rationale, design and baseline characteristics, 34 Investigating placebo effects in irritable bowel syndrome: A novel research design, 123 RANDOMIZED CONSENT DESIGN Randomized consent designs in randomized controlled trials: Systematic literature search, 320 RANDOMIZED PLACEBO-CONTROLLED CLINICAL TRIAL A randomized comparative trial of the efficacy and safety of exercise during pregnancy: Desig2n and methods, 531 RCTS Assessing the quality of RCTs on the effect of h-elemene, one ingredient of a Chinese herb, against malignant tumors, 70 RECALL OF INFORMATION Long term clinical trials: How much information do participants retain from the informed consent process?, 441
RANDOMISED CONSENT Review of randomised trials using the post-randomised consent (Zelen’s) design, 305
RECOVERY Total laparoscopic versus open surgery for stage 1 endometrial cancer: The LACE randomized controlled trial, 353
RANDOMISED CONTROLLED TRIAL Recruitment to a trial of self-care skills training in long-term health conditions: Analysis of the impact of patient attitudes and preferences, 49 A comparison of socio-demographic and psychological factors between patients consenting to randomisation and those selecting treatment (the ProtecT study), 413
RECRUITMENT Recruitment to a trial of self-care skills training in long-term health conditions: Analysis of the impact of patient attitudes and preferences, 49 Factors motivating dyspepsia patients to enter clinical research, 103 The Cost–Time Index: A new method for measuring the efficiencies of recruitment-resources in clinical trials, 494
600
Subject Index for Volume 27
Recruitment of the elderly into a pharmacologic prevention trial: The Ginkgo Evaluation of Memory Study experience, 541 Investigator beliefs and reported success in recruiting minority participants, 580
ROBUST ANALYSIS Robust analysis of biomarker data with informative missingness using a two-stage hypothesis test in an HIV treatment interruption trial: AIEDRP AIN503/ACTG A5217, 506
RECRUITMENT EFFICIENCY The Cost–Time Index: A new method for measuring the efficiencies of recruitment-resources in clinical trials, 494
SAFETY MONITORING Respiratory adverse event profiles in cystic fibrosis placebo subjects in short- and long-term inhaled therapy trials, 561
RESEARCH DESIGN Ancillary study to the PREFER trial: A descriptive study of participants’ patterns of self-monitoring — rationale, design and preliminary experiences, 23 PREFER study: A randomized clinical trial testing treatment preference and two dietary options in behavioral weight management — rationale, design and baseline characteristics, 34
SAMPLE SIZE A general approach for sample size and statistical power calculations assessing the effects of interventions using a mixture model in the presence of detection limits, 483
RESEARCH METHODOLOGY Investigating placebo effects in irritable bowel syndrome: A novel research design, 123 RESEARCH PARTICIPATION African Americans and participation in clinical trials: Differences in beliefs and attitudes by gender, 498 RESPIRATORY ADVERSE EVENTS Respiratory adverse event profiles in cystic fibrosis placebo subjects in short- and long-term inhaled therapy trials, 561 RETENTION OF INFORMATION Long term clinical trials: How much information do participants retain from the informed consent process?, 441
SELF-CARE Recruitment to a trial of self-care skills training in long-term health conditions: Analysis of the impact of patient attitudes and preferences, 49 SELF-MONITORING Ancillary study to the PREFER trial: A descriptive study of participants’ patterns of selfmonitoring — rationale, design and preliminary experiences, 23 SELF-REPORT Ancillary study to the PREFER trial: A descriptive study of participants’ patterns of self-monitoring — rationale, design and preliminary experiences, 23 SENSITIVITY Value of an Endpoints Committee versus the use of nosologists for validating cause of death, 333
REVIEW Review of randomised trials using the post-randomised consent (Zelen’s) design, 305
SES Adherence to calcium/vitamin D and estrogen protocols among diverse older participants enrolled in a clinical trial, 215
REVIEW RESEARCH ETHICS Randomized consent designs in randomized controlled trials: Systematic literature search, 320
SIMULATION Enriched analgesic efficacy studies: An assessment by clinical trial simulation, 165
RISK The challenges of new drugs benefits and risks analysis: Lessons from the ximelagatran FDA Cardiovascular Advisory Committee, 432
SOMATIC COMPLAINTS Adherence to calcium/vitamin D and estrogen protocols among diverse older participants enrolled in a clinical trial, 215
Subject Index for Volume 27
SPECIFICITY Value of an Endpoints Committee versus the use of nosologists for validating cause of death, 333 STANDARD BEHAVIORAL TREATMENT OF OBESITY Ancillary study to the PREFER trial: A descriptive study of participants’ patterns of self-monitoring — rationale, design and preliminary experiences, 23 PREFER study: A randomized clinical trial testing treatment preference and two dietary options in behavioral weight management — rationale, design and baseline characteristics, 34 STATISTICAL POWER A general approach for sample size and statistical power calculations assessing the effects of interventions using a mixture model in the presence of detection limits, 483 STEM CELL Comparison of survival times in a transplant study of hematologic disorders, 174 STUDY COORDINATION Informatics tools to improve clinical research study implementation, 112 SUDDEN CARDIAC DEATH Prediction of Arrhythmic Events with Positron Emission Tomography: PAREPET study design and methods, 374 SURGERY Center for clinical studies in a surgical department— An approach for more evidence-based medicine, 211 SURROGATE ENDPOINT Robust analysis of biomarker data with informative missingness using a two-stage hypothesis test in an HIV treatment interruption trial: AIEDRP AIN503/ACTG A5217, 506 SYMPATHETIC NERVES Prediction of Arrhythmic Events with Positron Emission Tomography: PAREPET study design and methods, 374 SYSTEMATIC LITERATURE SEARCH Randomized consent designs in randomized controlled trials: Systematic literature search, 320
601
TRAINING Study design and rationale of a mock phase I trial as an educational tool for clinical pharmacology residents, 183 TRANS FATTY ACID Rationale and design of the TRANSFACT project phase I: A study to assess the effect of the two different dietary sources of trans fatty acids on cardiovascular risk factors in humans, 364 TRANSPLANT Comparison of survival times in a transplant study of hematologic disorders, 174 TREATMENT PREFERENCE PREFER study: A randomized clinical trial testing treatment preference and two dietary options in behavioral weight management — rationale, design and baseline characteristics, 34 TREATMENT TRIAL Validation of complex interventions in a low back pain trial: Selective video analysis crossreferenced to clinical case notes, 404 TRIAL DESIGN Statistical evaluation of HIV vaccines in early clinical trials, 147 The challenges of new drugs benefits and risks analysis: Lessons from the ximelagatran FDA Cardiovascular Advisory Committee, 432 TRIAL PARTICIPATION Recruitment to a trial of self-care skills training in long-term health conditions: Analysis of the impact of patient attitudes and preferences, 49 A comparison of socio-demographic and psychological factors between patients consenting to randomisation and those selecting treatment (the ProtecT study), 413 TUMOR RESPONSE A new method of evaluating antitumor activity from measured tumor volumes, 269 TUMOR XENOGRAFT MODELS A new method of evaluating antitumor activity from measured tumor volumes, 269 TWO ARMED TRIAL Minimization method for balancing continuous prognostic variables between treatment and control groups using Kullback-Leibler divergence, 420
602
Subject Index for Volume 27
TWO-FACTOR ANALYSIS PREFER study: A randomized clinical trial testing treatment preference and two dietary options in behavioral weight management — rationale, design and baseline characteristics, 34
VISIT SCHEDULE A reduced frequency visit schedule underreports adverse events that resulted in dose modifications or treatment discontinuations in HIV/ AIDS clinical trials: ACTG DACS 207, 287
UNEQUAL RANDOMISATION The use of unequal randomisation ratios in clinical trials: A review, 1
WEST NILE VIRUS Regulatory challenges: Lessons from recent West Nile virus trials in the United States, 254
URVIVAL ANALYSIS Comparison of survival times in a transplant study of hematologic disorders, 174
XIMELAGATRAN The challenges of new drugs benefits and risks analysis: Lessons from the ximelagatran FDA Cardiovascular Advisory Committee, 432
VIABLE MYOCARDIUM Prediction of Arrhythmic Events with Positron Emission Tomography: PAREPET study design and methods, 374
ZELEN DESIGN Randomized consent designs in randomized controlled trials: Systematic literature search, 320
VIDEO ANALYSIS Validation of complex interventions in a low back pain trial: Selective video analysis crossreferenced to clinical case notes, 404
ZELEN’S METHOD Review of randomised trials using the post-randomised consent (Zelen’s) design, 305