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Basic Methods Handbook for Clinical Orthopaedic Research pp 133–142Cite as

Framework for Selecting Clinical Outcomes for Clinical Trials

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Abstract

Selection of sound and appropriate clinical outcomes is paramount when designing a clinical trial. The ability to draw definitive and meaningful conclusions from a clinical trial is dependent on the outcomes used and the information they provide. The clinical investigator must consider a number of factors when selecting clinical outcomes including the purpose and domain of the research question, the level of the assessment, whether to use performance-based or patient-reported measures, as well as the psychometric properties that accompany useful outcome measures. To comprehensively assess outcomes, measures used in a clinical trial should allow comparison to the population as a whole, draw definitive conclusions in the specific population or condition of interest, and consist of a combination of both performance-based and patient-reported measures. All outcomes should have appropriate levels of reliability, validity, and responsiveness to ensure that their use has methodological acceptability. Given the importance of proper selection of outcome measures, their inclusion and use in a clinical trial ought to be one of the initial steps taken during the development of the experiment.

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Authors and Affiliations

  1. Departments of Physical Therapy and Orthopaedic Surgery, University of Pittsburgh, Pittsburgh, PA, USA

    Adam J. Popchak, Andrew D. Lynch & James J. Irrgang

Authors
  1. Adam J. Popchak
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  2. Andrew D. Lynch
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  3. James J. Irrgang
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Corresponding author

Correspondence to Adam J. Popchak .

Editor information

Editors and Affiliations

  1. UPMC Rooney Sports Complex, University of Pittsburgh, Pittsburgh, PA, USA

    Volker Musahl

  2. Department of Orthopaedics, Sahlgrenska Academy, Gothenburg University, Sahlgrenska University Hospital, Gothenburg, Sweden

    Jón Karlsson

  3. Department of Orthopaedic Surgery and Traumatology, Kantonsspital Baselland (Bruderholz, Laufen und Liestal), Bruderholz, Switzerland

    Michael T. Hirschmann

  4. McMaster University, Hamilton, ON, Canada

    Olufemi R. Ayeni

  5. Hospital for Special Surgery, New York, NY, USA

    Robert G. Marx

  6. Department of Orthopaedic Surgery, NorthShore University HealthSystem, Evanston, IL, USA

    Jason L. Koh

  7. Institute for Medical Science in Sports, Osaka Health Science University, Osaka, Japan

    Norimasa Nakamura

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Popchak, A.J., Lynch, A.D., Irrgang, J.J. (2019). Framework for Selecting Clinical Outcomes for Clinical Trials. In: Musahl, V., et al. Basic Methods Handbook for Clinical Orthopaedic Research. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-58254-1_15

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  • DOI: https://doi.org/10.1007/978-3-662-58254-1_15

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  • Print ISBN: 978-3-662-58253-4

  • Online ISBN: 978-3-662-58254-1

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