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Statistical and Methodological Considerations for Randomized Controlled Trial Design in Physical Medicine and Rehabilitation. | LitMetric

Statistical and Methodological Considerations for Randomized Controlled Trial Design in Physical Medicine and Rehabilitation.

Am J Phys Med Rehabil

From the Department of Physical Medicine and Rehabilitation, Family and Community Medicine, and Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, Texas (BT); Center for Quantitative Sciences, Department of Biostatistics, Vanderbilt School of Medicine, Nashville, Tennessee (GDA); Department of Biostatistics and Data Science, University of Texas Health Science Center-Houston, Dallas, Texas (FA); Department of Biostatistics, Vanderbilt School of Medicine, Nashville, Tennessee (JD); Department of Physical Medicine and Rehabilitation, and Orthopedics, University of Texas Southwestern, Dallas, Texas (NBJ); and Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, Nashville, Tennessee (NBJ).

Published: October 2023

AI Article Synopsis

  • The abstract discusses the importance of well-designed randomized controlled trials in physical medicine and rehabilitation, highlighting unique challenges in the field, such as treatment blinding and varied patient responses.* -
  • It offers evidence-based strategies for addressing issues like treatment compliance, sample size estimation, and statistical methods for analyzing longitudinal data.* -
  • Readers are expected to understand these complexities and their impact on trial conduct, as well as recognize the role of data and safety monitoring boards in ensuring trial integrity.*

Article Abstract

Abstract: Well-designed randomized controlled clinical trials assessing treatments in the field of physical medicine and rehabilitation are essential for evidence-based patient care. However, there are challenges unique to clinical trials in physical medicine and rehabilitation due to complex health interventions in this field. We highlight routinely encountered empirical challenges and provide evidence-based recommendations on statistical and methodological approaches for the design and conduct of randomized controlled trials. Some of the issues addressed include challenges with blinding treatment groups in a rehabilitation setting, heterogeneity in treatment therapy, heterogeneity of treatment effects, uniformity in patient-reported outcome measures, and effect on power with varying scales of information. Furthermore, we discuss challenges with estimation of sample size and power, adaption to poor compliance with treatment and missing outcomes, and preferred statistical approaches for longitudinal data analysis.

To Claim Cme Credits: Complete the self-assessment activity and evaluation online at http://www.physiatry.org/JournalCME.

Cme Objectives: Upon completion of this article, the reader should be able to: (1) Appraise the complexities of interventions in physical medicine and rehabilitation and how these challenges impact the conduct of clinical trials; (2) Develop an analytical strategy for poor treatment compliance and missing outcomes that can compromise the causal effect sought in a randomized clinical trial; and (3) Recognize the role of a data and safety monitoring board in a clinical trial.

Level: Advanced.

Accreditation: The Association of Academic Physiatrists is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.The Association of Academic Physiatrists designates this Journal-based CME activity for a maximum of 1.0 AMA PRA Category 1 Credit(s) ™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10471787PMC
http://dx.doi.org/10.1097/PHM.0000000000002225DOI Listing

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