Randomized Clinical Trials of Nonpharmacological Treatments

Nonpharmacological treatments include a wide variety of treatments such as surgery, technical procedures, implantable devices, non-implantable devices, rehabilitation, psychotherapy, and behavioral interventions. This book focuses on the methods of assessing nonpharmacological treatments, highlighting specific issues, and discussing trial design

" a timely and critical addition to the literature. It covers many specific methodological challenges and issues in randomized clinical trials of nonpharmacological treatments, and presents examples of different clinical development stages in various clinical areas. The book offers a balanced mixture of technical and nontechnical aspects of nonpharmacological treatments. The book is easy for follow for a broad audience, including clinical trial practitioners, biostatisticians, and clinical and medical researchers. The text is nicely written and lucid While the intended audience for this book may be biostatisticians and clinical trial practitioners, I also recommend the book to interested clinical and medical researchers, and graduate students in relevant areas with relatively brief background in clinical trials."Xin Gao, Journal of the American Statistical Association, September 2014, Vol. 109" there do not appear to be any books dedicated to randomized controlled trials (RCTs) of non-pharmacological interventions (NPIs). As such, this book is very timely. Moreover, since the methodological and implementation issues in RCTs of NPIs are somewhat unique and often different from those of pharmacological treatments, this book is particularly welcome. a welcome addition to the literature in clinical trials methodology and highly recommended."ISCB News, 57, June 2014

Autorentext

Isabelle Boutron

Inhalt

Assessing Nonpharmacological Treatments: Theoretical Framework: Blinding in Nonpharmacological Randomized Controlled Trials. Placebo in Nonpharmacological Randomized Trials. Complexity of the Intervention. Learning Curves. Clustering Effects in RCTs of Nonpharmacological Interventions. Assessment of Harm. External Validity and Applicability of Nonpharmacological Trials. Assessing Nonpharmacological Interventions in Cluster Randomized Trials. Expertise-Based Trials. Pragmatic Trials and Nonpharmacological Evaluation. Preference Trials. Nonrandomized Studies to Evaluate the Effects of a Nonpharmacological Intervention. Methodological and Reporting Considerations for Systematic Reviews of Nonpharmacological Interventions. Accounting for the Complexity of the Intervention in Nonpharmacological Systematic Reviews. Reporting Guidelines for Nonpharmacological Trials. Assessing Nonpharmacological Treatments: Practical Examples: Assessing Cardiothoracic Surgery: Practical Examples. Assessing Obstetrics and Gynecology: Practical Examples. Assessing Lower Limb Arthroplasty: Practical Examples. Assessing Radiation Therapy: Practical Examples. Assessing Electroconvulsive Therapy: Practical Examples. Assessing Acupuncture: Practical Examples. Assessing Orthosis: Practical Examples. Assessing Rehabilitation: Practical Examples. Assessing Psychotherapy: Practical Examples. Assessing Psychosocial Interventions for Mental Health: Practical Examples. Assessing Behavioral Change Interventions for Mental Health: Practical Examples. Assessing Hypnotherapy: Practical Examples. Index.