Development of the Hygiene Extension Limb Position Pain (HELP) Tool to Monitor Waning of Clinical Efficacy in Patients with Spasticity or Cervical Dystonia Treated with Botulinum Toxins

Document Type

Conference Proceeding

Publication Date

1-2021

Publication Title

Toxicon

Abstract

Objectives: The HELP Tool is a patient-reported outcome (PRO) instrument, designed to provide greater discernment of waning clinical efficacy post botulinum neurotoxin A (BoNT-A) injections before the next scheduled treatment in patients with upper and/or lower limb spasticity or adults with cervical dystonia (CD). The impact of spasticity or CD symptom recurrence on patients will be better gauged with the HELP Tool, which will help determine appropriate treatment optimization. The HELP Tool will be used by patients (and parents/caregivers) with upper and/or lower limb spasticity or CD.

Design: Working with a consultant experienced in the development of PRO instruments, a panel of nine subject matter experts developed preliminary ~20-item questionnaires for potential use with patients with spasticity and CD and their parents/caregivers. Content validity will be assessed qualitatively (via patient feedback) and the questionnaire modified to provide a clinically useful screening tool to identify when treatment is waning prior to the next scheduled BoNT-A treatment and the effect on patients’ quality of life. Psychometric properties of the new tool will be assessed quantitatively. Patient satisfaction with treatment relevant to symptoms will be evaluated. After 12 interviews of adult spasticity and CD patients for concept elicitation, a virtual advisory board met to develop a relevant, meaningful HELP Tool and ensure content validity. This will be followed by a second round of questionnaire testing via cognitive debriefing interviews in a larger patient and parent/caregiver cohort, with subsequent HELP Tool finalization.

Results: This study was conducted in the US and Canada. The outcome of the HELP Tool development will be presented.

Conclusions: The HELP Tool development process has led to an easy-to-complete, short (5-10 min) PRO instrument for clinical use (injectors, therapists).

Volume

190

Issue

Supplement 1

First Page

S57

Comments

TOXINS Conference on Basic Science and Clinical Aspects of Botulinum and other Neurotoxins, Virtual, January 16-17, 2021.

DOI

10.1016/j.toxicon.2020.11.461

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