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

Antonini, Angelo; Odin, Per; Schmidt, Péter; Cubillos, Fernando; Standaert, David G.; Henriksen, Tove; Jimenez‐Shahed, Joohi; Alobaidi, Ali; Jalundhwala, Yash J.; Bao, Yanjun; Zamudio, Jorge; Parra, Juan Carlos; Kukreja, Pavnit; Onuk, Koray; Skalicky, Anne; Kleinman, Leah; Jones, Eddie; Metz, Steve; Fernández, Hubert H.

doi:10.1016/j.parkreldis.2021.10.009

Cited by 36 publications

(30 citation statements)

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“…The results of our study suggest that the 5–2-1 screening criteria would be a useful method for screening patients with advanced disease who may require more tailored assessment and treatment. Having easily identified people with PD who have a greater burden (5–2-1-positive patients), more comprehensive management instruments (i.e., Making Informed Decisions to Aid Timely Management of Parkinson’s Disease [MANAGE-PD] tool) [ 39 ] can be subsequently adopted to ensure further optimization of treatment. Despite recent advances in the development of screening and management tools, an urgent need remains for a screening tool that is simple to use and remember, is based on readily available information, and that clearly identifies patients with a greater disease burden who may benefit from treatment optimization, including a possible second-line therapy.…”

Section: Discussionmentioning

confidence: 99%

Does the 5–2-1 criteria identify patients with advanced Parkinson's disease? Real-world screening accuracy and burden of 5–2-1-positive patients in 7 countries

et al. 2022

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Background The burden of Parkinson’s disease (PD) worsens with disease progression. However, the lack of objective and uniform disease classification challenges our understanding of the incremental burden in patients with advanced Parkinson’s disease (APD) and suboptimal medication control. The 5–2-1 criteria was proposed by clinical consensus to identify patients with advancing PD. Our objective was to evaluate the screening accuracy and incremental clinical burden, healthcare resource utilization (HCRU), and humanistic burden in PD patients meeting the 5–2-1 screening criteria. Methods Data were drawn from the Adelphi Parkinson’s Disease Specific Program (DSP™), a multi-country point-in-time survey (2017–2020). People with PD who were naive to device-aided therapy and on oral PD therapy were included. Patients meeting the 5–2-1 screening criteria had one or more of the three clinical indicators of APD: (i) ≥5 doses of oral levodopa/day, OR (ii) “off” symptoms for ≥2 h of waking day, OR (iii) ≥1 h of troublesome dyskinesia. Clinician assessment of PD stage was used as the reference in this study. Clinical screening accuracy of the 5–2-1 criteria was assessed using area under the curve and multivariable logistic regression models. Incremental clinical, HCRU, and humanistic burden were assessed by known-group comparisons between 5 and 2-1-positive and negative patients. Results From the analytic sample (n = 4714), 33% of patients met the 5–2-1 screening criteria. Among physician-classified APD patients, 78.6% were 5–2-1 positive. Concordance between clinician judgment and 5–2-1 screening criteria was > 75%. 5–2-1-positive patients were nearly 7-times more likely to be classified as APD by physician judgment. Compared with the 5–2-1-negative group, 5–2-1-positive patients had significantly higher clinical, HCRU, and humanistic burden across all measures. In particular, 5–2-1-positive patients had 3.8-times more falls, 3.6-times higher annual hospitalization rate, and 3.4-times greater dissatisfaction with PD treatment. 5–2-1-positive patients also had significantly lower quality of life and worse caregiver burden. Conclusions 5–2-1 criteria demonstrated potential as a screening tool for identifying people with APD with considerable clinical, humanistic, and HCRU burden. The 5–2-1 screening criteria is an objective and reliable tool that may aid the timely identification and treatment optimization of patients inadequately controlled on oral PD medications.

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Section: Discussionmentioning

confidence: 99%

Does the 5–2-1 criteria identify patients with advanced Parkinson's disease? Real-world screening accuracy and burden of 5–2-1-positive patients in 7 countries

et al. 2022

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“…Inevitably, the proportion of patients included from each country varied from the original target (with almost 30% of patients from the USA), but all G7 countries were well represented (> 10% of the total sample); as such, the patients can be considered to be a broad international sample. The ‘gold standard’ used in this analysis was physician assessment of device-aided therapy eligibility in the next 24 months, which may not be as useful as using current eligibility, as has been used with assessments of other tools, such as MANAGE PD [ 22 ]. Also, with all 15 clinical indicators demonstrating good accuracy and validity, future research should focus on the accuracy of more concise combinations of these indicators to help physicians with their assessment of people with advancing PD.…”

Section: Discussionmentioning

confidence: 99%

Psychometric Properties of Clinical Indicators for Identification and Management of Advanced Parkinson’s Disease: Real-World Evidence From G7 Countries

et al. 2022

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Introduction: Standardized and validated criteria to define advanced Parkinson's disease (PD) or identify patient eligibility for deviceaided therapy are needed. This study assessed the psychometric properties of clinical indicators of advanced PD and eligibility for device-aided therapy in a large population. Methods: This retrospective analysis of the Adelphi Parkinson's Disease Specific Programme collected data from device-aided therapy-naı ¨ve people with PD in G7 countries. We assessed the presence of 15 clinical indicators of advancing PD and seven indicators of eligibility for deviceaided therapy in patients classified with advanced PD or as eligible for device-aided therapy by the treating physician. Accuracy was assessed using area under the curve (AUC) and

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“…As was mentioned in the introduction, other classifications for PD have been reported [ 3 , 4 , 6 , 9 , 11 , 13 , 14 , 15 ] and some are frequently used in clinical practice [ 3 , 4 ]. Motor symptoms are usually assessed by visual examination of motor tasks and semi-quantitative rating scales such as the H&Y [ 3 , 4 ], the Unified Parkinson’s Disease Rating Scale (UPDRS) [ 46 ], or more recently, the Movement Disorder Society—Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) [ 47 ].…”

Section: Discussionmentioning

confidence: 99%

“…In a very simple and visual classification, our proposal includes not only motor and non-motor symptoms but also cognition as a key aspect, due to its implications for disability for daily activities. Unlike other proposals that are based on categorizing whether patients are in an advanced stage of the disease or not [ 11 , 13 , 14 , 15 , 16 ], the MNCD classification can be applied from the beginning and allows for the monitoring of evolutionary changes throughout the course of the disease, with clearly defined stages. Moreover, this classification is applicable in each individual case in a simple way and is not the result of a cluster analysis used in many patients, which is sometimes difficult to transfer to the individual case.…”

Section: Discussionmentioning

confidence: 99%

“…Alternatively, 5-2-1 criteria (≥5 times oral levodopa tablet taken/day; ≥2 h of OFF time/day; ≥1 h/day of troublesome dyskinesia) is a simple and useful tool for early identification of advancing disease [ 13 , 14 ] but its applicability in all PD patients is uncertain (e.g., older PD patients without clear fluctuations but axial or cognitive symptoms). More recently, MANAGE-PD has been proposed as a simple, clinician-reported, screening web-based tool ( , accessed on 23 December 2021) to identify patients with PD inadequately controlled on oral medications [ 15 ]. Again, the application of this tool takes time and does not provide a straightforward clinical picture of a patient’s condition, which limits its value in routine clinical practice.…”

Section: Introductionmentioning

confidence: 99%

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MNCD: A New Tool for Classifying Parkinson’s Disease in Daily Clinical Practice

et al. 2021

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Background and objective: Parkinson’s disease (PD) is a clinically heterogeneous disorder in which the symptoms and prognosis can be very different among patients. We propose a new simple classification to identify key symptoms and staging in PD. Patients and Methods: Sixteen movement disorders specialists from Spain participated in this project. The classification was consensually approved after a discussion and review process from June to October 2021. The TNM classification and the National Institutes of Health Stroke Scale (NIHSS) were considered as models in the design. Results: The classification was named MNCD and included 4 major axes: (1) motor symptoms; (2) non-motor symptoms; (3) cognition; (4) dependency for activities of daily living (ADL). Motor axis included 4 sub-axes: (1) motor fluctuations; (2) dyskinesia; (3) axial symptoms; (4) tremor. Four other sub-axes were included in the non-motor axis: (1) neuropsychiatric symptoms; (2) autonomic dysfunction; (3) sleep disturbances and fatigue; (4) pain and sensory disorders. According to the MNCD, 5 stages were considered, from stage 1 (no disabling motor or non-motor symptoms with normal cognition and independency for ADL) to 5 (dementia and dependency for basic ADL). Conclusions: A new simple classification of PD is proposed. The MNCD classification includes 4 major axes and 5 stages to identify key symptoms and monitor the evolution of the disease in patients with PD. It is necessary to apply this proof of concept in a properly designed study.

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

Cited by 36 publications

References 27 publications

Does the 5–2-1 criteria identify patients with advanced Parkinson's disease? Real-world screening accuracy and burden of 5–2-1-positive patients in 7 countries

Does the 5–2-1 criteria identify patients with advanced Parkinson's disease? Real-world screening accuracy and burden of 5–2-1-positive patients in 7 countries

Psychometric Properties of Clinical Indicators for Identification and Management of Advanced Parkinson’s Disease: Real-World Evidence From G7 Countries

MNCD: A New Tool for Classifying Parkinson’s Disease in Daily Clinical Practice

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