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October 06, 2015; 85 (14) Article

Evaluation of outcome measures for neurogenic claudication

A patient-centered approach

John D. Markman, Jennifer S. Gewandter, Maria E. Frazer, Christine Pittman, Xueya Cai, Kushang V. Patel, Babak S. Jahromi, Robert H. Dworkin, Laurie B. Burke, John T. Farrar
First published September 9, 2015, DOI: https://doi.org/10.1212/WNL.0000000000002000
John D. Markman
From the Department of Neurosurgery, Translational Pain Research Program (J.D.M., M.E.F., C.P., B.S.J.), and Departments of Anesthesiology (J.S.G., R.H.D.) and Biostatistics and Computational Biology (X.C.), University of Rochester School of Medicine and Dentistry, NY; Department of Anesthesiology and Pain Medicine (K.V.P.), University of Washington, Seattle; LORA Group, LLC (L.B.B.), Royal Oak, MD; and Department of Biostatistics and Epidemiology (J.T.F.), University of Pennsylvania, Philadelphia.
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Jennifer S. Gewandter
From the Department of Neurosurgery, Translational Pain Research Program (J.D.M., M.E.F., C.P., B.S.J.), and Departments of Anesthesiology (J.S.G., R.H.D.) and Biostatistics and Computational Biology (X.C.), University of Rochester School of Medicine and Dentistry, NY; Department of Anesthesiology and Pain Medicine (K.V.P.), University of Washington, Seattle; LORA Group, LLC (L.B.B.), Royal Oak, MD; and Department of Biostatistics and Epidemiology (J.T.F.), University of Pennsylvania, Philadelphia.
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Maria E. Frazer
From the Department of Neurosurgery, Translational Pain Research Program (J.D.M., M.E.F., C.P., B.S.J.), and Departments of Anesthesiology (J.S.G., R.H.D.) and Biostatistics and Computational Biology (X.C.), University of Rochester School of Medicine and Dentistry, NY; Department of Anesthesiology and Pain Medicine (K.V.P.), University of Washington, Seattle; LORA Group, LLC (L.B.B.), Royal Oak, MD; and Department of Biostatistics and Epidemiology (J.T.F.), University of Pennsylvania, Philadelphia.
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Christine Pittman
From the Department of Neurosurgery, Translational Pain Research Program (J.D.M., M.E.F., C.P., B.S.J.), and Departments of Anesthesiology (J.S.G., R.H.D.) and Biostatistics and Computational Biology (X.C.), University of Rochester School of Medicine and Dentistry, NY; Department of Anesthesiology and Pain Medicine (K.V.P.), University of Washington, Seattle; LORA Group, LLC (L.B.B.), Royal Oak, MD; and Department of Biostatistics and Epidemiology (J.T.F.), University of Pennsylvania, Philadelphia.
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Xueya Cai
From the Department of Neurosurgery, Translational Pain Research Program (J.D.M., M.E.F., C.P., B.S.J.), and Departments of Anesthesiology (J.S.G., R.H.D.) and Biostatistics and Computational Biology (X.C.), University of Rochester School of Medicine and Dentistry, NY; Department of Anesthesiology and Pain Medicine (K.V.P.), University of Washington, Seattle; LORA Group, LLC (L.B.B.), Royal Oak, MD; and Department of Biostatistics and Epidemiology (J.T.F.), University of Pennsylvania, Philadelphia.
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Kushang V. Patel
From the Department of Neurosurgery, Translational Pain Research Program (J.D.M., M.E.F., C.P., B.S.J.), and Departments of Anesthesiology (J.S.G., R.H.D.) and Biostatistics and Computational Biology (X.C.), University of Rochester School of Medicine and Dentistry, NY; Department of Anesthesiology and Pain Medicine (K.V.P.), University of Washington, Seattle; LORA Group, LLC (L.B.B.), Royal Oak, MD; and Department of Biostatistics and Epidemiology (J.T.F.), University of Pennsylvania, Philadelphia.
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Babak S. Jahromi
From the Department of Neurosurgery, Translational Pain Research Program (J.D.M., M.E.F., C.P., B.S.J.), and Departments of Anesthesiology (J.S.G., R.H.D.) and Biostatistics and Computational Biology (X.C.), University of Rochester School of Medicine and Dentistry, NY; Department of Anesthesiology and Pain Medicine (K.V.P.), University of Washington, Seattle; LORA Group, LLC (L.B.B.), Royal Oak, MD; and Department of Biostatistics and Epidemiology (J.T.F.), University of Pennsylvania, Philadelphia.
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Robert H. Dworkin
From the Department of Neurosurgery, Translational Pain Research Program (J.D.M., M.E.F., C.P., B.S.J.), and Departments of Anesthesiology (J.S.G., R.H.D.) and Biostatistics and Computational Biology (X.C.), University of Rochester School of Medicine and Dentistry, NY; Department of Anesthesiology and Pain Medicine (K.V.P.), University of Washington, Seattle; LORA Group, LLC (L.B.B.), Royal Oak, MD; and Department of Biostatistics and Epidemiology (J.T.F.), University of Pennsylvania, Philadelphia.
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Laurie B. Burke
From the Department of Neurosurgery, Translational Pain Research Program (J.D.M., M.E.F., C.P., B.S.J.), and Departments of Anesthesiology (J.S.G., R.H.D.) and Biostatistics and Computational Biology (X.C.), University of Rochester School of Medicine and Dentistry, NY; Department of Anesthesiology and Pain Medicine (K.V.P.), University of Washington, Seattle; LORA Group, LLC (L.B.B.), Royal Oak, MD; and Department of Biostatistics and Epidemiology (J.T.F.), University of Pennsylvania, Philadelphia.
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John T. Farrar
From the Department of Neurosurgery, Translational Pain Research Program (J.D.M., M.E.F., C.P., B.S.J.), and Departments of Anesthesiology (J.S.G., R.H.D.) and Biostatistics and Computational Biology (X.C.), University of Rochester School of Medicine and Dentistry, NY; Department of Anesthesiology and Pain Medicine (K.V.P.), University of Washington, Seattle; LORA Group, LLC (L.B.B.), Royal Oak, MD; and Department of Biostatistics and Epidemiology (J.T.F.), University of Pennsylvania, Philadelphia.
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Citation
Evaluation of outcome measures for neurogenic claudication
A patient-centered approach
John D. Markman, Jennifer S. Gewandter, Maria E. Frazer, Christine Pittman, Xueya Cai, Kushang V. Patel, Babak S. Jahromi, Robert H. Dworkin, Laurie B. Burke, John T. Farrar
Neurology Oct 2015, 85 (14) 1250-1256; DOI: 10.1212/WNL.0000000000002000

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Abstract

Objectives: To determine whether patients with neurogenic claudication associated with lumbar spinal stenosis would prefer a treatment that makes it possible for them to walk farther or walk with less pain; to examine associations between this treatment preference and patient-reported and in-clinic treadmill testing measures of walking ability and walking-associated pain.

Methods: In this cross-sectional study, 269 patients with neurogenic claudication were asked to report their pain intensity when walking, complete the Swiss Spinal Stenosis Questionnaire, rank their outcome preferences for treatment, and undergo standardized treadmill testing, including measures of final pain rating and time to first pain of moderate intensity (Tfirst). Descriptive statistics were used to characterize patient preferences for treatment outcome. Associations between self-report questionnaires and standardized treadmill testing outcomes were evaluated using Spearman correlations.

Results: Seventy-nine percent of patients expressed a preference for treatment that allowed them to walk with less pain. Preference for reduced pain was associated with higher pain during daily walking, along with a shorter Tfirst and higher final pain severity on treadmill testing. In contrast, patient preference for treatment outcome was not associated with self-reported measures of daily walking capacity or walking distance on the treadmill.

Conclusions: A majority of patients with neurogenic claudication prioritized walking with reduced pain over walking farther. Reduction in pain while walking may therefore constitute a sufficient patient-focused treatment outcome for the majority of these patients. These results have implications for clinical trial design and assessment of treatment efficacy in neurogenic claudication.

GLOSSARY

NRS=
numeric rating scale;
PRO=
patient-reported outcome;
SSS=
Swiss Spinal Stenosis;
Tfirst=
time to first moderate pain intensity

Footnotes

  • Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

  • Received March 22, 2015.
  • Accepted in final form June 11, 2015.
  • © 2015 American Academy of Neurology
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