Selection bias and covariate imbalances in randomzied clinical trials [[electronic resource] /] / Vance W. Berger

• Record Nr.: UNINA9910144745303321
• Autore: Berger Vance
• Pubbl/distr/stampa: Hoboken, NJ, : John Wiley & Sons, c2005
• ISBN: 1-280-55597-1; 9786610555970; 0-470-86364-1; 0-470-86363-3
• Descrizione fisica: 1 online resource (220 p.)
• Collana: Statistics in practice
• Disciplina: 610.724; 610/.72/4
• Soggetti: Clinical trials - Statistical methods - Evaluation; Ranking and selection (Statistics) - Evaluation; Sampling (Statistics) - Evaluation; Electronic books.
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes bibliographical references (p. 187-198) and indexes.
• Nota di contenuto: Selection Bias and Covariate Imbalances in Randomized Clinical Trials; Contents; Preface; Part I: Is There a Problem with Reliability in Medical Studies?; 1 An Evolution of Comparative Methodology; 1.1 Single-subject studies; 1.2 Case series and cohort studies; 1.3 Historical controls; 1.4 Parallel control groups; 1.5 Matched studies; 1.6 Randomization; 1.7 Advance randomization; 1.8 Allocation concealment; 1.9 Residual selection bias; 2 Susceptibility of Randomized Trials to Subversion and Selection Bias; 2.1 Can randomized trials be subverted?; 2.2 If randomized trials are subverted, do they cease to be randomized trials?2.3 What is masking?; 2.4 What is allocation concealment?; 2.5 A double standard; 2.6 What if allocation concealment could be ensured?; 3 Evidence of Selection Bias in Randomized Trials; 3.1 The burden of proof regarding the existence of selection bias in randomized trials; 3.2 Indirect population-level evidence that selection bias exists in randomized trials; 3.3 Direct trial-level evidence that selection bias ; exists in randomized trials; 3.3.1 Heparin for myocardial infarction; 3.3.2 University Group Diabetes Program3.3.3 Talc and mustine for pleural effusions; 3.3.4 Tonsillectomy for recurrent throat infection in children; 3.3.5 Oxytocin and amniotomy for induction of labor; 3.3.6 Western Washington Intracoronary Streptokinase Trial; 3.3.7 RSV immune globulin in infants and young children with respiratory syncytial virus; 3.3.8 A trial to assess episiotomy; 3.3.9 Canadian National Breast Cancer Screening Study; 3.3.10 Surgical trial; 3.3.11 Lifestyle Heart Trial; 3.3.12 Coronary Artery Surgery Study; 3.3.13 Etanercept for children with juvenile rheumatoid arthritis; 3.3.14 Edinburgh Randomized Trial of Breast-Cancer Screening3.3.15 Captopril Prevention Project; 3.3.16 Göteborg (Swedish) Mammography Trial; 3.3.17 HIP Mammography Trial; 3.3.18 Hypertension Detection and Follow-Up Program; 3.3.19 Randomized trial to prevent vertical transmission of HIV-1; 3.3.20 Effectiveness trial of a diagnostic test; 3.3.21 South African trial of high-dose chemotherapy for metastatic breast cancer; 3.3.22 Randomized study of a culturally sensitive AIDS education program; 3.3.23 Runaway Youth Study; 3.3.24 Cluster randomized trial of palliative care; 3.3.25 Randomized trial of methadone with or without heroin3.3.26 Randomized NINDS trial of tissue plasminogen activator for acute ischemic stroke; 3.3.27 Norwegian Timolol Trial; 3.3.28 Laparoscopic versus open appendectomy; 3.3.29 The Losartan Intervention for Endpoint Reduction in Hypertension (LIFE) Study; 3.3.30 The Heart Outcomes Prevention Evaluation (HOPE) Study; 3.4 In search of better evidence; 4 Impact of Selection Bias in Randomized Trials; 4.1 Quantifying the prediction of future allocations: balanced blocks; 4.2 Quantifying prediction of future allocations: unbalanced blocks; 4.3 Quantifying covariate imbalance resulting from selection bias
• Sommario/riassunto: Selection bias can, and does, occur, even in randomized clinical trials. Steps need to be taken in order to ensure that this does not compromise the integrity of clinical trials; hence "Selection Bias and Covariate Imbalances in Randomized Clinical Trials" offers a comprehensive treatment of the subject and the methodology involved. This book:Provides an overview of the hierarchy of study designs, and justifies the position of randomised trials at the top of this hierarchy.Discusses the strengths and defects of randomisation, and provides real evidence to justify con