Validation and clinical value of the MANAGE-PD tool: A clinician-reported tool to identify Parkinson's disease patients inadequately controlled on oral medications

Angelo Antonini; Per Odin; Peter Schmidt; Fernando Cubillos; David G Standaert; Tove Henriksen; Joohi Jimenez-Shahed; Ali Alobaidi; Yash J Jalundhwala; Yanjun Bao; Jorge Zamudio; Juan Carlos Parra; Pavnit Kukreja; Koray Onuk; Anne M Skalicky; Leah Kleinman; Eddie Jones; Sharon Metz; Hubert H Fernandez

doi:10.1016/j.parkreldis.2021.10.009

Validation and clinical value of the MANAGE-PD tool: A clinician-reported tool to identify Parkinson's disease patients inadequately controlled on oral medications

Parkinsonism Relat Disord. 2021 Nov:92:59-66. doi: 10.1016/j.parkreldis.2021.10.009. Epub 2021 Oct 13.

Authors

Angelo Antonini¹, Per Odin², Peter Schmidt³, Fernando Cubillos⁴, David G Standaert⁵, Tove Henriksen⁶, Joohi Jimenez-Shahed⁷, Ali Alobaidi⁸, Yash J Jalundhwala⁹, Yanjun Bao¹⁰, Jorge Zamudio¹¹, Juan Carlos Parra¹², Pavnit Kukreja¹³, Koray Onuk¹⁴, Anne M Skalicky¹⁵, Leah Kleinman¹⁶, Eddie Jones¹⁷, Sharon Metz¹⁸, Hubert H Fernandez¹⁹

Affiliations

¹ Parkinson and Movement Disorders Unit, Center for Neurodegenerative Diseases CESNE, Department of Neuroscience, University of Padova, Padova, Italy. Electronic address: angelo.antonini@unipd.it.
² University of Lund, Lund, Sweden. Electronic address: per.odin@med.lu.se.
³ Brody School of Medicine, East Carolina University, Greenville, NC, USA. Electronic address: pnschmidt@gmail.com.
⁴ Scientific Consultant, USA. Electronic address: fer.cubillos@gmail.com.
⁵ Center for Neurodegeneration and Experimental Therapeutics, University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: dstandaert@uabmc.edu.
⁶ Movement Disorder Clinic, University Hospital of Bispebjerg, Copenhagen, Denmark. Electronic address: then0003@bbh.regionh.dk.
⁷ Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address: Joohi.Jimenez-shahed@mountsinai.org.
⁸ AbbVie Inc., North Chicago, IL, USA; University of Illinois at Chicago, Chicago, IL, USA. Electronic address: ali.alobaidi@abbvie.com.
⁹ AbbVie Inc., North Chicago, IL, USA. Electronic address: yash.jalundhwala@abbvie.com.
¹⁰ AbbVie Inc., North Chicago, IL, USA. Electronic address: carol.bao@abbvie.com.
¹¹ AbbVie Inc., North Chicago, IL, USA. Electronic address: Jorge.zamudio@abbvie.com.
¹² AbbVie Inc., North Chicago, IL, USA. Electronic address: juancarlos.parrariaza@abbvie.com.
¹³ AbbVie Inc., North Chicago, IL, USA. Electronic address: pavnit.kukreja@abbvie.com.
¹⁴ AbbVie Inc., North Chicago, IL, USA. Electronic address: Koray.onuk@abbvie.com.
¹⁵ Evidera, Bethesda, MD, USA. Electronic address: Anne.Skalicky@evidera.com.
¹⁶ Evidera, Bethesda, MD, USA. Electronic address: Leah.Kleinman@evidera.com.
¹⁷ Adelphi Real World, Adelphi Mill, Bollington, UK. Electronic address: eddie.jones@adelphigroup.com.
¹⁸ Parkinson's Foundation, Miami, FL, USA. Electronic address: smetz@parkinson.org.
¹⁹ Center for Neurological Restoration, Cleveland Clinic, Cleveland, OH, USA. Electronic address: FERNANH@ccf.org.

PMID: 34695657
DOI: 10.1016/j.parkreldis.2021.10.009

Abstract

Introduction: Making Informed Decisions to Aid Timely Management of Parkinson's Disease (MANAGE-PD) is a clinician-reported tool designed to facilitate timely identification and management of patients with advancing Parkinson's disease (PD) with suboptimal symptom control while on standard therapy. The objective of this study was to evaluate the validity and clinical value of the tool.

Methods: Driven by structured inputs from a steering committee and panel of PD experts, the tool was developed to classify patients into 3 categories. Validity and clinical value were elucidated using a two-pronged approach: (i) hypothetical patient vignettes (n = 10) developed based on the MANAGE-PD tool and rated by 17 PD specialists and 400 general neurologists (GN) and (ii) patients with PD (n = 2546) managed in real-world clinical settings. Vignette validity was based on concordance between PD experts' clinical judgement and MANAGE-PD vignette categorization. Patient-level data was used for known-group comparisons (validity) and discordant pair analysis (clinical value).

Results: The tool demonstrated strong validity and clinical value among PD specialists (intraclass coefficient [ICC] 0.843; Fleiss weighted kappa [ƙ_weighted] 0.79) and GN (ICC 0.690; ƙ_weighted 0.65) using patient vignettes. MANAGE-PD also demonstrated real-world validity and clinical value based on ability to identify patients with incrementally higher clinical, economic, and humanistic PD burden across categories of the tool (p < 0.01).

Conclusions: MANAGE-PD demonstrated robust validity and clinical value in identifying patients with suboptimal PD symptom control. Clinical use of MANAGE-PD may complement treatment decision-making and facilitate timely and comprehensive management of patients with advancing PD.

Keywords: Clinician decision-making; Clinician-reported; Continuous subcutaneous apomorphine infusion (CSAI); Deep brain stimulation (DBS); Dyskinesia; Levodopa-carbidopa intestinal gel (LCIG); MANAGE-PD; Motor fluctuations; Parkinson disease; Patient identification; Wearing-off.

Publication types

Evaluation Study
Research Support, Non-U.S. Gov't
Validation Study

MeSH terms

Aged
Antiparkinson Agents / therapeutic use
Clinical Decision-Making / methods*
Decision Support Systems, Clinical / standards*
Female
Humans
Male
Parkinson Disease / diagnosis*
Parkinson Disease / therapy*
Reproducibility of Results
Symptom Assessment / methods
Symptom Assessment / standards*

Substances

Antiparkinson Agents