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. 2024 May 14:14:26.
doi: 10.5334/tohm.886. eCollection 2024.

Validation of a New Patient-Reported Outcome Measure of the Functional Impact of Essential Tremor on Activities of Daily Living

Ludy C Shih  1   2 , Michael T Stevenson  3 , Steven Bellows  4 , Alfonso Fasano  5   6   7 , Sheng-Han Kuo  8 , Kelly E Lyons  9 , Henry Moore  10 , Holly A Shill  11 , Aparna Wagle Shukla  12 , Carlos Singer  10 , Rodger J Elble  13
Affiliations

Validation of a New Patient-Reported Outcome Measure of the Functional Impact of Essential Tremor on Activities of Daily Living

Ludy C Shih et al. Tremor Other Hyperkinet Mov (N Y). .

Abstract

Background: The Essential Tremor Rating Assessment Scale (TETRAS) is a popular scale for essential tremor (ET), but its activities of daily living (ADL) and performance (P) subscales are based on a structured interview and physical exam. No patient-reported outcome (PRO) scale for ET has been developed according to US regulatory guidelines.

Objective: Develop and validate a TETRAS PRO subscale.

Methods: Fourteen items, rated 0-4, were derived from TETRAS ADL and structured cognitive interviews of 18 ET patients. Convergent validity analyses of TETRAS PRO versus TETRAS ADL, TETRAS-P, and the Quality of Life in Essential Tremor Questionnaire (QUEST) were computed for 67 adults with ET or ET plus. Test-retest reliability was computed at intervals of 1 and 30 days. The influence of mood (Hospital Anxiety and Depression Scale, HADS) and coping behaviors (Essen Coping Questionnaire, ECQ) was examined with multiple linear regression.

Results: TETRAS PRO was strongly correlated (r > 0.7) with TETRAS ADL, TETRAS-P, and QUEST and exhibited good to excellent reliability (Cronbach alpha 95%CI = 0.853-0.926; 30-day test-retest intraclass correlation 95%CI = 0.814-0.921). The 30-day estimate of minimum detectable change (MDC) was 6.6 (95%CI 5.2-8.0). TETRAS-P (rsemipartial = 0.607), HADS depression (rsemipartial = 0.384), and the coping strategy of information seeking and exchange of experiences (rsemipartial = 0.176) contributed statistically to TETRAS PRO in a multiple linear regression (R2 = 0.67).

Conclusions: TETRAS PRO is a valid and reliable scale that is influenced strongly by tremor severity, moderately by mood (depression), and minimally by coping skills. The MDC for TETRAS PRO is probably sufficient to detect clinically important change.

Keywords: anxiety; coping skills; depression; essential tremor; patient-reported outcome measure.

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Conflict of interest statement

LCS receives consulting fees from Medtronic, WCG Medavante, and Encora Therapeutics, receives honoraria from Wiley for editorial work, and research grant funding from Praxis Precision Medicines and NIH. MTS is supported by research funds from Praxis, Biogen, and NIH. SB has served as site PI for clinical research trials funded by Sage and AbbVie. AF has stock ownership in Inbrain Pharma and has received payments as consultant and/or speaker from Abbvie, Abbott, Boston Scientific, Ceregate, Dompé Farmaceutici, Inbrain Neuroelectronics, Ipsen, Medtronic, Iota, Syneos Health, Merz. He has received research support from Abbvie, Boston Scientific, Medtronic, Praxis, ES and receives royalties from Springer. SHK receives consulting fees from Praxis, Sage, and Jazz. KEL is president of the International Essential Tremor Foundation. HM received consulting fees from Ipsen Pharma and receives research support from MODUS Outcomes LLC, TEVA Pharmaceuticals, SAGE Therapeutics, Bukwang Pharmaceuticals, Neurocrine Biosciences, CDHI Foundation. HAS received research support from Transposon, NINDS, Parkinson Study Group/UCB, Parkinson’s Foundation, MJFF, Jazz Pharmaceuticals, Intra-cellular Therapeutics and Barrow Neurological Foundation. HAS has also served as a consultant for Abbvie, Sage/Biogen, Praxis, KeifeRx, Fasikl and Jazz Pharmaceuticals. AWS reports grant support from the NIH R01 NS122943 as PI and R01 NS121120-01 as a Co-I. She reports past funding from Benign Essential Blepharospasm Research Foundation, Dystonia Coalition, Dystonia Medical Research Foundation, and National Organization for Rare Disorders. AWS has received consultant fees from Merz, Jazz, Fasikl, Encora and Acadia. She is the current Vice President for the Tremor Research Group and recent advisor for Supernus and Biogen-Sage. CS received grant funding from Teva Pharmaceuticals and the Parkinson Foundation. RJE receives consulting fees from Applied Therapeutics, ES Therapeutics, Neurocrine Biosciences, Encora, Fasikl, Jazz, and Sage; and serves on the International Essential Tremor Foundation Medical Advisory Board.

Figures

Linear regression of TETRAS PRO with TETRAS ADL, TETRAS Performance, and QUEST
Figure 1
Linear regression of TETRAS PRO with TETRAS ADL, TETRAS Performance, and QUEST. A linear regression of TETRAS ADL vs TETRAS Performance is shown for comparison. The 95% confidence limits (maroon) and 95% prediction limits (orange) are shown. The maximum possible scores of TETRAS PRO, TETRAS ADL, AND TETRAS Performance are 56, 48, and 64.
See this image and copyright information in PMC

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