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Regression Models for Ordinal Outcomes

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1 Credit CME

In the December 1, 2020, issue of JAMA, Self et al1 reported a randomized clinical trial that evaluated whether treatment with hydroxychloroquine improved clinical outcomes of adults hospitalized with COVID-19 compared with placebo. The primary outcome was the patient’s clinical status 14 days after randomization, assessed with an ordinal 7-category scale ranging from worst (“death”) to the best (“discharged from the hospital and able to perform normal activities”). The term “ordinal” is applied to an outcome measure for which its mutually exclusive categories can be ordered by their clinical preference. The primary outcome was analyzed with a multivariable ordinal logistic regression model, which is a regression model for an ordinal dependent variable. The authors found that there was not a statistically significant difference between the hydroxychloroquine and placebo groups in clinical status 14 days after randomization.

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Article Information

Corresponding Author: Benjamin French, PhD, Department of Biostatistics, Vanderbilt University Medical Center, 2525 West End Ave, Ste 1100, Nashville, TN 37203 (b.french@vumc.org).

Published Online: August 4, 2022. doi:10.1001/jama.2022.12104

Conflict of Interest Disclosures: None reported.

References
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Self  WH , Semler  MW , Leither  LM ,  et al; National Heart, Lung, and Blood Institute PETAL Clinical Trials Network.  Effect of hydroxychloroquine on clinical status at 14 days in hospitalized patients with COVID-19: a randomized clinical trial.   JAMA. 2020;324(21):2165-2176. doi:10.1001/jama.2020.22240PubMedGoogle ScholarCrossref
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Stevens  SS .  On the theory of scales of measurement.   Science. 1946;103(2684):677-680. doi:10.1126/science.103.2684.677PubMedGoogle ScholarCrossref
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Roozenbeek  B , Lingsma  HF , Perel  P ,  et al; IMPACT (International Mission on Prognosis and Clinical Trial Design in Traumatic Brain Injury) Study Group; CRASH (Corticosteroid Randomisation After Significant Head Injury) Trial Collaborators.  The added value of ordinal analysis in clinical trials: an example in traumatic brain injury.   Crit Care. 2011;15(3):R127. doi:10.1186/cc10240PubMedGoogle ScholarCrossref
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Liu  Q , Shepherd  BE , Li  C , Harrell  FE  Jr .  Modeling continuous response variables using ordinal regression.   Stat Med. 2017;36(27):4316-4335. doi:10.1002/sim.7433PubMedGoogle ScholarCrossref
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McCullagh  P .  Regression models for ordinal data.   J R Stat Soc Series B Stat Methodol. 1980;42(2):109-142.Google Scholar
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Harrel  F . Assessing the proportional odds assumption and its impact. Statistical Thinking blog. March 9, 2022. Accessed April 29, 2022. https://www.fharrell.com/post/impactpo
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Schildcrout  JS , Harrell  FE  Jr , Heagerty  PJ ,  et al.  Model-assisted analyses of longitudinal, ordinal outcomes with absorbing states.   Stat Med. 2022;41(14):2497-2512. doi:10.1002/sim.9366PubMedGoogle ScholarCrossref
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Norton  EC , Dowd  BE , Maciejewski  ML .  Marginal effects—quantifying the effect of changes in risk factors in logistic regression models.   JAMA. 2019;321(13):1304-1305. doi:10.1001/jama.2019.1954PubMedGoogle ScholarCrossref
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Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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