Disclosures: Edward Dabrowski, MD: Allergan (Products/Services: Yes) (Consultant/Advisory Board, Speaker/Honoraria includes speakers bureau, symposia, and expert witness)IPSEN (Products/Services: Yes) (Consultant/Advisory Board, Speaker/Honoraria includes speakers bureau, symposia, and expert witness)Myobloc (Products/Services: Yes) (Consultant/Advisory Board, Speaker/Honoraria includes speakers bureau, symposia, and expert witness)Xeomin (Products/Services: Yes) (Consultant/Advisory Board, Speaker/Honoraria includes speakers bureau, symposia, and expert witness)

Objective: The development of the “HELP Tool”, consisting of a patient-reported outcome (PRO) instrument, for greater discernment of waning clinical efficacy after botulinum neurotoxin A (BoNT-A) injections prior to next scheduled treatment in patients with upper and/or lower limb spasticity or adults with cervical dystonia (CD), to gauge the impact of spasticity or CD symptom recurrence on patients, and aid in determining the appropriate treatment optimization.

Design: Working with a consultant experienced with the development and psychometric validation 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 then be assessed qualitatively (patient feedback) and the questionnaire modified to provide a clinically useful screening tool to identify when treatment is waning prior to next scheduled BoNT-A treatment. Psychometric properties of the new tool will be assessed quantitatively. Patient satisfaction with treatment relevant to symptoms will also be evaluated. Setting : After the first 12 interviews of adult spasticity and CD patients for concept elicitation, a virtual advisory board with subject matter experts will be conducted to develop and refine a relevant and meaningful HELP Tool and ensure content validity. This will be followed by a second round of testing the questionnaires via interviews in a larger patient and parent/caregiver cohort, with subsequent HELP Tool finalization. The final HELP Tool will undergo quantitative instrument validation in up to 200 patients. Participants : Patients with upper and/or lower limb spasticity or CD and their respective parents/caregivers.

Interventions: BoNT-A.

Main Outcome Measures: Form and content of final HELP Tool questionnaire; validation of HELP Tool.

Results: This study is ongoing. Conclusions: Results of the HELP Tool development process, as well as initial validation study results, will be presented.

Level of Evidence: Level V

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PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/development-and-validation-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/