1st Edition

Randomized Clinical Trials of Nonpharmacological Treatments

Edited By Isabelle Boutron, Philippe Ravaud, David Moher Copyright 2012
    403 Pages
    by Chapman & Hall

    403 Pages 22 B/W Illustrations
    by Chapman & Hall

    Nonpharmacological treatments include a wide variety of treatments such as surgery, technical procedures, implantable and non-implantable devices, rehabilitation, psychotherapy, and behavioral interventions. Unlike pharmacological treatments, these have no specific requirements for approval. Consequently, they can be widely proposed in clinical practice but may not have been adequately evaluated. This situation is an important barrier for the evaluation of the beneficial effects of these treatments and the conduct of clinical trials. Randomized Clinical Trials of Nonpharmacologic Treatments focuses on the methods for assessing nonpharmacological treatments, highlighting specific issues and trial design.


    • Chapters written by international experts in the field

    • Highlights specific issues in assessing nonpharmacological treatments in trials including:

      • how to overcome the difficulties of blinding patients, care providers, and outcome assessors

      • the complexity of the intervention, the learning curve, and the clustering effect

      • placebos that can be used

      • issues of assessing harm and assessing the applicability of trials

    • Presents a variety of trial designs for nonpharmacological treatments—including cluster randomized controlled trials, expertise-based trials, pragmatic trials, and nonrandomized trials.

    • Provides several examples of the planning, conduct, analyses, and reporting of trials in different fields, including surgery, technical interventions, medical devices, rehabilitation, psychotherapy, and behavioral interventions.

    Providing practical examples that underline these issues and solutions, this book is one of the first to exclusively explore this topic, discussing various categories of treatments, from surgical procedures to psychotherapy.

    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.


    Isabelle Boutron

    "… 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