Randomized Clinical Trials of Nonpharmacological Treatments

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ISBN 9781420088014
Cat# C8017



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  • Highlights specific issues in assessing nonpharmacological treatments in trials
  • Discusses all possible designs of trials on nonpharmacological treatments
  • Provides practical examples to highlight the issues and solutions in assessing nonpharmacological treatments in trials
  • Considers various categories of treatments from surgical procedures to psychotherapy


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.

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


Editorial Reviews

"… 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