MANAGE-PD: A clinician-reported tool to identify patients with Parkinson’s Disease inadequately controlled on oral medications – Results from vignette-based validation (P5.8-039)

Objective: To evaluate the reliability and validity of MANAGE-PD tool. Background: Timely identification of advancing symptoms of people living with Parkinson’s Disease (PD), thereby optimizing their window for utilization for device-aided therapies are areas for clinical practice improvement. MANAGE-PD is a simple clinician-reported screening tool developed to address this practice gap. It is aimed to assist clinicians’ decision making for the timely evaluation of PD symptoms. Design/Methods: Hypothetical vignettes (n=10) were developed to represent a wide spectrum of disease severity. A vignette-based validation was conducted via a web-based survey of selected panelists comprised of highly experienced movement disorder specialists (MDS) from US and Europe. A Steering Committee classified each vignette into 3 categories: (i) adequately controlled on oral therapy; (ii) inadequately controlled on oral therapy and recommend oral optimization only; (iii) inadequately controlled on oral therapy and recommend evaluation for device-aided therapies along with oral optimization. Each panelist evaluated one anchor vignette (used for assessing response consistency) and four randomly assigned vignettes using the MANAGE-PD tool. Concordance between clinical judgment for management of patient versus MANAGE-PD recommendation was assessed. Results: The panel included MDS (n=19) from 15 countries, with extensive experience in treating PD [Mean: 24.4±7.6 years; Mean patients treated/month: 73.2±45.4]. In open-ended feedback, panelists reported no issues with usage of the tool. The determination of inadequate symptom control and possible eligibility of device-aided therapies was made based on frequency and severity of motor symptoms, non-motor symptoms and functional limitations. A high concordance between clinical judgement and MANAGE-PD recommendation was observed (Intra-class co-efficient: 0.82; weighted kappa statistic:0.71; unweighted kappa statistic:0.78; concordance for the categories ranged from 82.35–88.24%). Conclusions: MANAGE-PD demonstrated high reliability and validity. Future steps include validation with a large global survey of general neurologists and optimizing scoring algorithm based on patient-level data. Disclosure: Dr. Antonini has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Acadia, Sunovion, UCB, Boston Scientific, Angelini, Medtronic, GE, Boehringer Ingelheim, AbbVie, Zambon. Dr. Antonini has received research support from Mundipharma. Dr. Odin has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie Inc., Britannia, Boehringer-Ingelheim, Nordic Infucare, UCB and Zambon PO har received royalities from Uni-Med Verlag. Dr. Jalundhwala has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie. Dr. Jalundhwala holds stock and/or stock options in AbbVie which sponsored research in which Dr. Jalundhwala was involved as an investigator. Dr. Schmidt has nothing to disclose. Dr. Skalicky has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Evidera. Dr. Skalicky has received research support from AbbVie. Dr. Kleinman has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Evidera. Dr. Kleinman has received research support from Evidera, A PPD Company. Dr. Zamudio has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie. Dr. Zamudio holds stock and/or stock options in AbbVie. Dr. Zamudio has received research support from AbbVie. Dr. Onuk has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie Inc. Dr. Onuk holds stock and/or stock options in AbbVie Inc. Dr. Kukreja has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie Inc. Dr. Kukreja holds stock and/or stock options in AbbVie Inc which sponsored research in which Dr. Kukreja was involved as an investigator. Dr. Kukreja holds stock and/or stock options in AbbVie Inc. Dr. Bao has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie, Inc. Dr. Bao holds stock and/or stock options in AbbVie, Inc., which sponsored research in which Dr. Bao was involved as an investigator. Dr. Cubillos has nothing to disclose. Dr. Fernandez has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Prime Education Inc. International Parkinson and Movement Disorders Society, Carling Communications, Medscape, Vindico, AbbVie, Biogen, Blackthorn, Inventiv, Kyowa Hakko Kirin, Medscape, Voyager, Sunovion, and Pfizer Pharmaceuticals. Dr. Fernandez has received royalty, license fees, or contractual rights payments from Demos Publishing, Cambridge University Press. Dr. Fernandez has received research support from Abbvie, Biotie/Acorda Therapeutics, Michael J. Fox Foundation, Movement Disorders Society, NIH/NINDS, Parkinson Study Group, Rhythm, Sunovion.