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. 2023 Feb 1;141(2):159-166.
doi: 10.1001/jamaophthalmol.2022.3225.

Utility Assessment of Moderate to Severe Thyroid Eye Disease Health States

Terry J Smith  1   2 , Kimberly Cockerham  3   4   5 , Gary Lelli  6 , Chitra Choudhary  7 , Stephanie Taylor  8 , Naina Barretto  8 , Ashley Enstone  9 , Louisa Oliver  9 , Judah Lynch  9 , Robert J Holt  8
Affiliations

Utility Assessment of Moderate to Severe Thyroid Eye Disease Health States

Terry J Smith et al. JAMA Ophthalmol. .

Erratum in

  • Update to Open Access Status.
    [No authors listed] [No authors listed] JAMA Ophthalmol. 2023 Feb 1;141(2):213. doi: 10.1001/jamaophthalmol.2023.0109. JAMA Ophthalmol. 2023. PMID: 36795108 Free PMC article. No abstract available.

Abstract

Importance: Thyroid eye disease (TED) results in varying degrees of proptosis and diplopia negatively affecting quality of life (QoL), producing possibly substantial visual changes, disfigurement, and disability.

Objective: To determine the association of varying TED severities with QoL in a non-TED population by assessing health state utility scores.

Design, setting, and participants: This qualitative study, conducted from April 20, 2020, to April 29, 2021, assessed health states for active, moderate-severe TED, and values were elicited using time trade-off methods. Six health states of varying severity were determined from 2 placebo-controlled clinical trials (171 patients with TED and clinical activity score ≥4, ±diplopia/proptosis) and refined using interviews with US patients with TED (n = 6). Each health state description was validated by interviews with additional TED patient advocates (n = 3) and physician experts (n = 3). Health state descriptions and a QOL questionnaire were piloted and administered to a general population. Visual analog scales (VASs) were also administered to detect concurrence of the findings.

Main outcomes and measures: TED health state utility scores and whether they differ from one another were assessed using Shapiro-Wilk, Kruskal-Wallis, pairwise Wilcoxon rank sum, and paired t tests.

Results: A total of 111 participants completed time trade-off interviews. The mean (SD) utility value was 0.44 (0.34). The lowest (worse) mean utility value was observed in the most severe disease state (constant diplopia/large proptosis) with 0.30 (95% CI, 0.24-0.36), followed by constant diplopia/small proptosis (0.34; 95% CI, 0.29-0.40), intermittent or inconstant diplopia/large proptosis (0.43; 95% CI, 0.36-0.49), no diplopia/large proptosis (0.46; 95% CI, 0.40-0.52), and intermittent or inconstant diplopia/small proptosis (0.52; 95% CI, 0.45-0.58). The highest (best) mean value, 0.60 (95% CI, 0.54-0.67), was observed for the least severe disease state (no diplopia/small proptosis).

Conclusions and relevance: These findings suggest that patients with active, moderate-severe TED may have substantial disutility, with increasing severity of proptosis/diplopia more likely to have detrimental associations with QoL. These health state scores may provide a baseline for determining QoL improvement in these TED health states (utility gains) treated with new therapies.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Smith reported being issued US patents covering the use of IGF-1 receptor inhibitors in thyroid eye disease, which are held by UCLA and the Lundquist Institute and receiving consultant fees from Horizon Therapeutics, Veridian, and Lundbeck outside the submitted work. Dr Cockerham reported receiving consultant fees from Horizon Pharmaceuticals and Viridian during the conduct of the study. Drs Lelli and Choudhary reported receiving consultant fees from Horizon Therapeutics outside the submitted work. Dr Taylor reported being an employee of Horizon Therapeutics during the study and completion of the article. Dr Barretto reported being an employee of Horizon Therapeutics and owning stock in the company outside the submitted work. Dr Enstone reported receiving grants from Horizon Therapeutics and being an employee of Adelphi Values PROVE during the conduct of the study. Drs Enstone, Oliver, and Lynch reported being employees of Adelphi Values PROVE (Adelphi Values received budgetary compensation from Horizon Therapeutics for conduct of the study). Dr Holt reported being an employee of Horizon Therapeutics and owning stock in the company outside the submitted work. No other disclosures were reported.

Figures

Figure.
Figure.. Distribution of Utility Values by Health State
Figure displays median Q1, Q3. TTO indicates time trade-off.
See this image and copyright information in PMC

Comment in

References

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