Randomized Clinical Trials of Nonpharmacological Treatments: 1st Edition (Hardback) book cover

Randomized Clinical Trials of Nonpharmacological Treatments

1st Edition

Edited by Isabelle Boutron, Philippe Ravaud, David Moher

Chapman and Hall/CRC

403 pages | 22 B/W Illus.

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pub: 2011-12-19
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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.


"… 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

Table of Contents

Assessing Nonpharmacological Treatments: Theoretical Framework

Blinding in Nonpharmacological Randomized Controlled Trials

Isabelle Boutron and Philippe Ravaud

Placebo in Nonpharmacological Randomized Trials

Asbjørn Hróbjartsson and Franklin G. Miller

Complexity of the Intervention

Patricia Yudkin, Rafael Perera, and Paul Glasziou

Learning Curves

Jonathan A. Cook and Craig R. Ramsay

Clustering Effects in RCTs of Nonpharmacological Interventions

Jonathan A. Cook

Assessment of Harm

Panagiotis N. Papanikolaou and John P.A. Ioannidis

External Validity and Applicability of Nonpharmacological Trials

Isabelle Boutron and Philippe Ravaud

Assessing Nonpharmacological Interventions in Cluster Randomized Trials

Bruno Giraudeau and Philippe Ravaud

Expertise-Based Trials

Jonathan A. Cook

Pragmatic Trials and Nonpharmacological Evaluation

Merrick Zwarenstein

Preference Trials

Arthur Kangombe, Helen Tilbrook, and David Torgerson

Nonrandomized Studies to Evaluate the Effects of a Nonpharmacological Intervention

Barnaby C. Reeves

Methodological and Reporting Considerations for Systematic Reviews of Nonpharmacological Interventions

Alexander Tsertsvadze, Larissa Shamseer, and David Moher

Accounting for the Complexity of the Intervention in Nonpharmacological Systematic Reviews

Sasha Shepperd and Simon Lewin

Reporting Guidelines for Nonpharmacological Trials

Isabelle Boutron and Philippe Ravaud

Assessing Nonpharmacological Treatments: Practical Examples

Assessing Cardiothoracic Surgery: Practical Examples

Tom Treasure and Martin Utley

Assessing Obstetrics and Gynecology: Practical Examples

Vincenzo Berghella and Jorge E. Tolosa

Assessing Lower Limb Arthroplasty: Practical Examples

David Biau and Remy Nizard

Assessing Radiation Therapy: Practical Examples

Hidefumi Aoyama

Assessing Electroconvulsive Therapy: Practical Examples

Keith G. Rasmussen

Assessing Acupuncture: Practical Examples

Hugh MacPherson

Assessing Orthosis: Practical Examples

Katherine Sanchez, Claire Jourdan, François Rannou, and Serge Poiraudeau

Assessing Rehabilitation: Practical Examples

Nadine Elizabeth Foster

Assessing Psychotherapy: Practical Examples

Paula P. Schnurr

Assessing Psychosocial Interventions for Mental Health: Practical Examples

Graham Thornicroft and Michele Tansella

Assessing Behavioral Change Interventions for Mental Health: Practical Examples

Charles Abraham

Assessing Hypnotherapy: Practical Examples

Isabelle Marc


About the Series

Chapman & Hall/CRC Biostatistics Series

Learn more…

Subject Categories

BISAC Subject Codes/Headings:
MATHEMATICS / Probability & Statistics / General
MEDICAL / Pharmacology
MEDICAL / Biostatistics