Table Of Content

Controlled Clinical ‘Trials DESIGN, METHODS, AND ANALYSIS Volume 25, Number 1, 2004 Contents KATHLEEN B. DRENNAN Editorial Original articles GUANGYONG ZOU, ALLAN DONNER A simple alternative confidence interval for the difference between two proportions TONY VANGENEUGDEN, ANNOUSCHKA LAENEN, HELENA GEYS, DIDIER RENARD, GEERT MOLENBERGHS Applying linear mixed models to estimate reliability in clinical trial data with repeated measurements PHIL EDWARDS, IAN ROBERTS, PETER SANDERCOCK, CHRIS FROST Follow-up by mail in clinical trials: does questionnaire length matter? TIFFANY L. GARY, MARIAN BATTS-TURNER, LEE R. BONE, HSIN-CHIEH YEH, NAE-YUH WANG, FELICIA HILL-BRIGGS, DAVID M. LEVINE, NEIL R. POWE, MARTHA N. HILL, CHRISTOPHER SAUDEK, MAURA McGUIRE, FREDERICK L. BRANCATI A randomized controlled trial of the effects of nurse case manager and community health worker team interventions in urban African-Americans with type 2 diabetes Letters to the Editor EDWARD L. KORN, BORIS FREIDLIN, STEPHEN L. GEORGE Data monitoring and large apparent treatment effects JOHN WHITEHEAD Stopping rules for clinical trials DAVID CLAYTON, KEITH WHEATLEY Reply JESSICA ANCKER Assessing patient comprehension of informed consent forms WILLIAM BURMAN, PETER BREESE Reply Design papers LESLIE A. KALISH, BEVERLY BUCZYNSKI, PATRICIA CONNELL, ALLISON GEMMEL, CHRISTINE GOERTZ, ERIC A. MACKLIN, MAY PIAN-SMITH, STEPHANIE STEVENS, JAMES THOMPSON, PETER VALASKATGIS, PETER M. WAYNE, RANDALL M. ZUSMAN Stop Hypertension with the Acupuncture Research Program (SHARP): clinical trial design and screening results R. EDWARD VARNER, CHRISTINE C. IRELAND, ROBERT L. SUMMITT JR., HOLLY E. RICHTER, LEE A. LEARMAN, ERIC VITTINGHOFF, MIRIAM KUPPERMANN, EUGENE WASHINGTON, STEPHEN B. HULLEY FOR THE MS RESEARCH GROUP Medicine or Surgery (Ms): a randomized clinical trial comparing hysterectomy and medical treatment in premenopausal women with abnormal uterine bleeding A. JOHN RUSH, MAURIZIO FAVA, STEPHEN R. WISNIEWSKI, PHILIP W. LAVORI, MADHUKAR H. TRIVEDI, HAROLD A. SACKEIM, MICHAEL E. THASE, ANDREW A. NIERENBERG, FREDERIC M. QUITKIN, T. MICHAEL KASHNER, DAVID J. KUPFER, JERROLD F. ROSENBAUM, JONATHAN ALPERT, JONATHAN W. STEWART, PATRICK J. McGRATH, MELANIE M. BIGGS, KATHY SHORES-WILSON, BARRY D. LEBOWITZ, LOUISE RITZ, GEORGE NIEDEREHE, FOR THE STAR*D INVESTIGATORS GROUP Sequenced treatment alternatives to relieve depression (STAR*D): rationale and design Volume 25, Number 2, 2004 Contents Original articles HEEJUNG BANG, LIYUN NI, CLARENCE E. DAVIS Assessment of blinding in clinical trials MATTHEW S. MAYO, BYRON J. GAJEWSKI Bayesian sample size calculations in phase II clinical trials using informative conjugate priors WILLIAM B. CAPRA Comparing the power of the discontinuation design to that of the classic randomized design on time-to-event endpoints Design papers BEATRICE A. GOLOMB, MICHAEL H. CRIQUI, HALBERT L. WHITE, JOEL E. DIMSDALE The UCSD Statin Study: a randomized controlled trial assessing the impact of statins on selected noncardiac outcomes PHYLLIS J. GOODMAN, CATHERINE M. TANGEN, JOHN J. CROWLEY, SUSAN M. CARLIN, ANNE RYAN, CHARLES A. COLTMAN JR., LESLIE G. FORD, IAN M. THOMPSON Implementation of the Prostate Cancer Prevention Trial (PCPT) HIPAID MANAGEMENT COMMITTEE ON BEHALF OF THE HIPAID COLLABORATIVE GROUP MARLENE FRANSEN Preventing chronic ectopic bone-related pain and disability after hip replacement surgery with perioperative ibuprofen. A multicenter, randomized, double-blind, placebo-controlled trial (HIPAID) Volume 25, Number 3, 2004 Contents Original articles LYNDSEY WATSON, RHONDA SMALL, STEPHANIE BROWN, WENDY DAWSON, JUDITH LUMLEY Mounting a community-randomized trial: sample size, matching, selection, and randomization issues in PRISM ROGER P. A’HERN Widening eligibility to phase II trials: constant arcsine difference phase II trials Design papers CINDY L. CARMACK TAYLOR, MURRAY A. SMITH, CARL DE MOOR, ANDREA L. DUNN, CURTIS PETTAWAY, RENA SELLIN, CHUSLIP CHARNSANGAVE], MOLLY C. HANSEN, ELLEN R. GRITZ Quality of life intervention for prostate cancer patients: design and baseline characteristics of the active for life after cancer trial THERESA W. GUILBERT, WAYNE J. MORGAN, MARZENA KRAWIEC, ROBERT F. LEMANSKE JR., CHRIS SORKNESS, STANLEY J. SZEFLER, GARY LARSEN, JOSEPH D. SPAHN, ROBERT S. ZEIGER, GREGORY HELDT, ROBERT C. STRUNK, LEONARD B. BACHARIER, GORDON R. BLOOMBERG, VERNON M. CHINCHILLI, SUSAN J. BOEHMER, ELIZABETH A. MAUGER, DAVID T. MAUGER, LYNN M. TAUSSIG, FERNANDO D. MARTINEZ The Prevention of Early Asthma in Kids study: design, rationale and methods for the Childhood Asthma Research and Education network EARLY TREATMENT FOR RETINOPATHY OF PREMATURITY COOPERATIVE GROUP Multicenter trial of early treatment for retinopathy of prematurity: study design JAMES L. KEPNER, MYRON N. CHANG Samples of exact k-stage group sequential designs for Phase II and Pilot studies Volume 25, Number 4, 2004 Contents Original articles MONA N. FOUAD, GISELLE CORBIE-SMITH, DAVID CURB, BARBARA V. HOWARD, CHARLES MOUTON, MICHAEL SIMON, GREG TALAVERA, JOANICE THOMPSON, CHING-YUN WANG, CORNELIA WHITE, ROSALIE YOUNG Special populations recruitment for the Women’s Health Initiative: successes and limitations DONALD M. THEA, CHESWA VWALIKA, PRISCA KASONDE, CHIPEPO KANKASA, MOSES SINKALA, KATHERINE SEMRAU, ERIN SHUTES, CHRISTINE AYASH, WEI-YANN TSAI, GRACE ALDROVANDI, LOUISE KUHN Issues in the design of a clinical trial with a behavioral intervention the Zambia exclusive breast- feeding study KRISHAN MAGGON Investigator and site selection and performing GCP clinical studies in India EUGENE Z. ODDONE, MAREN K. OLSEN, JENNIFER HOFF LINDQUIST, MELINDA ORR, RONNIE HORNER, DOMENIC REDA, PHILIP LAVORI, GARY JOHNSON, JOSEPH COLLINS, JOHN R. FEUSSNER Enrollment in clinical trials according to patients race: experience from the VA Cooperative Studies Program (1975-2000) MARK GABBAY, JOANNA THOMAS When free condoms and spermicide are not enough: barriers and solutions to participant recruitment to community-based trials LYNN K. GORDON, ANTONI RIBAS, STEVEN NUSINOWITZ, LISA H. BUTTERFIELD, JOHN A. GLASPY, JAMES S. ECONOMOU, BRADLEY R. STRAATSMA Surveillance of the eye and vision in a clinical trial of MART1-transformed dendritic cells for metastatic melanoma SIEW F. CHAN, PETRA MACASKILL, LES IRWIG, STEPHEN D. WALTER Adjustment for baseline measurement error in randomized controlled trials induces bias QILONG YI, TONY PANZARELLA, PAUL COREY Incorporating the sampling variation of the disease prevalence when calculating the sample size in a study to determine the diagnostic accuracy of a test Volume 25, Number 5, 2004 Contents Original articles RICKEY EDWARD CARTER Application of stochastic processes to participant recruitment in clinical trials RONALD G. MARKS Validating electronic source data in clinical trials SHANNON L. MIHALKO, GRETCHEN A. BRENES, DEBORAH F. FARMER, JEFFREY A. KATULA, RAJESH BALKRISHNAN, DEBORAH J. BOWEN Challenges and innovations in enhancing adherence The SEARCH Study Group SEARCH for Diabetes in Youth: a multicenter study of the prevalence, incidence and classification of diabetes mellitus in youth WILLIAM M. LEE, JULES L. DIENSTAG, KAREN L. LINDSAY, ANNA S. LOK, HERBERT L. BONKOVSKY, MITCHELL L. SHIFFMAN, GREGORY T. EVERSON, ADRIAN M. BISCEGLIE, TIMOTHY R. MORGAN, MARC G. GHANY, CHIHIRO MORISHIMA, ELIZABETH C. WRIGHT, JAMES E. EVERHART Evolution of the HALT-C Trial: pegylated interferon as maintenance therapy for chronic hepatitis C in previous interferon nonresponders Design papers ALAN D. HUTSON, MARY E. REID The utility of partial cross-over designs in early phase randomized prevention trials THERESA CHARROIS, STEPHEN NEWMAN, DON SIN, AMBIKAIPAKAN SENTHILSELVAN, ROSS T. TSUYUKI Improving asthma symptom control in rural communities: the design of the Better Respiratory Education and Asthma Treatment in Hinton and Edson study Discussion papers VANCE W. BERGER, SHERRI WEINSTEIN Ensuring the comparability of comparison groups: is randomization enough? LUCIANO J.M. COSTA, ANA CAROLINA G. XAVIER, AURO DEL GIGLIO Negative results in cancer clinical trials—equivalence or poor accrual? Volume 25, Number 6, 2004 Contents Review paper RICHARD J. WILLKE, LAURIE B. BURKE, PENNIFER ERICKSON Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels Original articles MICHAEL DOMANSKI, ELLIOTT M. ANTMAN, SONJA McKINLAY, SERGEI VARSHAVSKY, PYOTR PLATONOV, SUSAN F. ASSMANN, JAMES NORMAN Geographic variability in patient characteristics, treatment and outcome in an International Trial of Magnesium in acute myocardial infarction DICK M. GOEDHART, PIETER ZANEN, JAN-WILLEM J. LAMMERS Analyzing bronchodilation with emphasis on disease type, age and sex ATSUSHI HAGINO, CHIKUMA HAMADA, ISAO YOSHIMURA, YASUO OHASHI, JUNICHI SAKAMOTO, HIROAKI NAKAZATO Statistical comparison of random allocation methods in cancer clinical trials KARSTEN LAURITSEN, ALESSIO DEGL’ INNOCENTI, LENE HENDEL, JORGEN PRAEST, MOGENS F. LYTJE, KJJELD CLEMMENSEN-ROTNE, INGELA WIKLUND Symptom recording in a randomised clinical trial: paper diaries vs. electronic or telephone data capture JOHN H. MONTGOMERY, MATTHEW BYERLY, THOMAS CARMODY, BAITAO LI, DANIEL R. MILLER, FEMINA VARGHESE, RHIANNON HOLLAND An analysis of the effect of funding source in randomized clinical trials of second generation antipsychotics for the treatment of schizophrenia Discussion paper VANCE W. BERGER On the generation and ownership of alpha in medical studies List of reviewers Author Index for Volume 25 Subject Index for Volume 25 Contents Volume for Volume 25