Randomized Clinical Trials of Nonpharmacological Treatments

1. Auflage 2012
ISBN: 978-1-4200-8801-4
Verlag: Taylor & Francis Ltd

Buch, Englisch, 403 Seiten, Format (B × H): 166 mm x 241 mm, Gewicht: 706 g

Reihe: Chapman & Hall/CRC Biostatistics Series

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.

Features:

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.

Zielgruppe

Biostatiticians, clinical research managers, clinicians in academia and pharma industry interested in assessing nonpharmacological treatments.

Autoren/Hrsg.

Boutron, Isabelle

Ravaud, Philippe

Moher, David

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Mathematik | Informatik EDV | Informatik Angewandte Informatik Bioinformatik
• Naturwissenschaften Biowissenschaften Angewandte Biologie Biomathematik
• Naturwissenschaften Biowissenschaften Angewandte Biologie Bioinformatik
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Biomedizin, Medizinische Forschung, Klinische Studien
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizinische Mathematik & Informatik

Inhaltsverzeichnis

Assessing Nonpharmacological Treatments: Theoretical FrameworkBlinding in Nonpharmacological Randomized Controlled TrialsIsabelle Boutron and Philippe RavaudPlacebo in Nonpharmacological Randomized TrialsAsbjørn Hróbjartsson and Franklin G. MillerComplexity of the InterventionPatricia Yudkin, Rafael Perera, and Paul GlasziouLearning CurvesJonathan A. Cook and Craig R. RamsayClustering Effects in RCTs of Nonpharmacological InterventionsJonathan A. CookAssessment of HarmPanagiotis N. Papanikolaou and John P.A. IoannidisExternal Validity and Applicability of Nonpharmacological TrialsIsabelle Boutron and Philippe RavaudAssessing Nonpharmacological Interventions in Cluster Randomized TrialsBruno Giraudeau and Philippe RavaudExpertise-Based TrialsJonathan A. CookPragmatic Trials and Nonpharmacological EvaluationMerrick ZwarensteinPreference TrialsArthur Kangombe, Helen Tilbrook, and David TorgersonNonrandomized Studies to Evaluate the Effects of a Nonpharmacological InterventionBarnaby C. ReevesMethodological and Reporting Considerations for Systematic Reviews of Nonpharmacological InterventionsAlexander Tsertsvadze, Larissa Shamseer, and David MoherAccounting for the Complexity of the Intervention in Nonpharmacological Systematic ReviewsSasha Shepperd and Simon LewinReporting Guidelines for Nonpharmacological TrialsIsabelle Boutron and Philippe RavaudAssessing Nonpharmacological Treatments: Practical ExamplesAssessing Cardiothoracic Surgery: Practical ExamplesTom Treasure and Martin UtleyAssessing Obstetrics and Gynecology: Practical ExamplesVincenzo Berghella and Jorge E. TolosaAssessing Lower Limb Arthroplasty: Practical ExamplesDavid Biau and Remy NizardAssessing Radiation Therapy: Practical ExamplesHidefumi AoyamaAssessing Electroconvulsive Therapy: Practical ExamplesKeith G. RasmussenAssessing Acupuncture: Practical ExamplesHugh MacPhersonAssessing Orthosis: Practical ExamplesKatherine Sanchez, Claire Jourdan, François Rannou, and Serge PoiraudeauAssessing Rehabilitation: Practical ExamplesNadine Elizabeth FosterAssessing Psychotherapy: Practical ExamplesPaula P. SchnurrAssessing Psychosocial Interventions for Mental Health: Practical ExamplesGraham Thornicroft and Michele TansellaAssessing Behavioral Change Interventions for Mental Health: Practical ExamplesCharles AbrahamAssessing Hypnotherapy: Practical ExamplesIsabelle Marc
Index