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
To cite this abstract in AMA style:
Dabrowski E, Patel AT, Wietek S. 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 [abstract]. PM R. 2020; 12(S1)(suppl 1). 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/. Accessed May 8, 2025.« Back to AAPM&R Annual Assembly 2020
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/