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Patient-Centered Outcome Measures to Assess Functioning in Randomized Controlled Trials of Low-Vision Rehabilitation: A Review

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Abstract

Low-vision rehabilitation (LVR) aims to improve the functioning of patients with chronic uncorrectable visual impairment. LVR is inherently a patient-centered intervention since its approach and goals are dictated by the needs and abilities of each individual patient. Accordingly, it is essential to have patient-centered outcome (PCO) measures to assess and compare the efficacy and effectiveness of low-vision interventions; however, there is a lack of evidence on the effectiveness of LVR interventions. We reviewed the literature in order to identify randomized controlled trials (RCTs) in the field of LVR and the outcome measures used to assess patient functioning in these trials. We identified 15 RCTs of LVR that employed nine unique patient-reported, five unique performance-based, and one hybrid (combined patient-reported and performance) outcome measures. Since these trials used distinct tools to assess patient functioning, it is difficult to compare the effectiveness of competing rehabilitation interventions across studies. Selecting valid outcome measures that are both relevant to LVR goals of specific patient populations and that measure functioning across a range of visually demanding tasks could improve the ability to detect the effect of LVR and to compare rehabilitation strategies. There are advantages and limitations to the use of both patient-reported and performance-based outcome measures, and additional work should be undertaken to explore the relationship between these modes of assessment, as well as strategies for optimally integrating these approaches. Careful selection of outcome measures in the design of future RCTs in LVR may lead to improved understanding of the effectiveness of LVR and, ultimately, to improved functioning of patients with low vision.

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Author Contributions

Each author meets the criteria for authorship laid out by the International Committee of Medical Journal Editors. Each author has given final approval for the manuscript to be submitted for consideration for publication. All authors agree to be accountable for all aspects of the work and Dr. Ehrlich will act as the overall guarantor. The individual contributions of each author are listed: Joshua Ehrlich: Conception and design of the study, writing of the manuscript. George Spaeth: Conception and design of the study, critical revision of the manuscript. Noelle Carlozzi: Critical revision of the manuscript. Paul Lee: Conception and design of the study, critical revision of the manuscript. This submission has not been previously published elsewhere and is not simultaneously being considered for any other publication.

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Authors and Affiliations

  1. Department of Ophthalmology and Visual Sciences, University of Michigan, 1000 Wall Street, Ann Arbor, MI, 48103, USA

    Joshua R. Ehrlich & Paul P. Lee

  2. Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI, USA

    Joshua R. Ehrlich, Noelle E. Carlozzi & Paul P. Lee

  3. Center for Eye Policy and Innovation, University of Michigan, Ann Arbor, MI, USA

    Joshua R. Ehrlich & Paul P. Lee

  4. Glaucoma Research Center, Wills Eye Hospital, Philadelphia, PA, USA

    George L. Spaeth

  5. Center for Clinical Outcomes Development and Application (CODA), University of Michigan, Ann Arbor, MI, USA

    Noelle E. Carlozzi

  6. Department of Physical Medicine and Rehabilitation, University of Michigan, Ann Arbor, MI, USA

    Noelle E. Carlozzi

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  1. Joshua R. Ehrlich
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Correspondence to Joshua R. Ehrlich.

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This work was supported by the Heed Ophthalmic Foundation through an unrestricted Grant to Joshua Ehrlich (no Grant Number).

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Joshua Ehrlich, George Spaeth, Noelle Carlozzi, and Paul Lee have no conflicts of interest that impacted or are likely to be perceived as impacting their contribution to this work. Paul Lee is a consultant to the Centers for Disease Control and Prevention. All money goes to his institution.

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Ehrlich, J.R., Spaeth, G.L., Carlozzi, N.E. et al. Patient-Centered Outcome Measures to Assess Functioning in Randomized Controlled Trials of Low-Vision Rehabilitation: A Review. Patient 10, 39–49 (2017). https://doi.org/10.1007/s40271-016-0189-5

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