| 1. |
- Antonini, Angelo, et al.
(författare)
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Psychometric Properties of Clinical Indicators for Identification and Management of Advanced Parkinson’s Disease : Real-World Evidence From G7 Countries
- 2022
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Ingår i: Neurology and Therapy. - : Springer Science and Business Media LLC. - 2193-8253 .- 2193-6536. ; 11:1, s. 303-318
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Standardized and validated criteria to define advanced Parkinson’s disease (PD) or identify patient eligibility for device-aided 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-naïve people with PD in G7 countries. We assessed the presence of 15 clinical indicators of advancing PD and seven indicators of eligibility for device-aided 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 multivariable logistic regression models. Construct validity was examined via known-group comparisons of disease severity and burden among patients with and without each clinical indicator. Results: Of 4714 PD patients, 14.9% were classified with advanced PD and 17.5% as eligible for device-aided therapy by physician judgment. The presence of each clinical indicator was 1.9- to 7.3-fold more likely in patients classified with advanced PD. Similarly, the presence of device-aided therapy eligibility indicators was 1.8- to 5.5-fold more likely in patients considered eligible for device-aided therapy. All indicators demonstrated high clinical screening accuracy for identifying advanced PD (AUC range 0.84–0.89) and patients eligible for device-aided therapy (AUC range 0.73–0.80). The Unified Parkinson’s Disease Rating Scale (UPDRS) score, cognitive function, quality of life, and caregiver burden were significantly worse in indicator-positive patients. Conclusion: Specific clinical indicators of advanced PD and eligibility for device-aided therapy demonstrated excellent psychometric properties in a large sample, and thus may provide an objective and reliable approach for patient identification and treatment optimization.
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| 2. |
- Chaudhuri, K. Ray, et al.
(författare)
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Economic Burden of Parkinson’s Disease : A Multinational, Real-World, Cost-of-Illness Study
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Ingår i: Drugs - Real World Outcomes. - 2199-1154.
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Tidskriftsartikel (refereegranskat)abstract
- Background: Parkinson’s disease is now one of the fastest-growing neurodegenerative disorders in the developed world, with an increasing prevalence and associated socioeconomic costs. Progression of the disease leads to a gradual deterioration in patients’ quality of life, despite optimal treatment, and both medical and societal needs increase, often with the assistance of paid and/or unpaid caregivers. Objective: We aimed to quantify the incremental economic burden of Parkinson’s disease by disease severity in a real-world setting across differing geographic regions. Methods: Demographics, clinical characteristics, health status, patient quality of life, caregiver burden, and healthcare resource utilization data were drawn from the Adelphi Parkinson’s Disease Specific Program™, conducted in the USA, five European countries, and Japan. Results: A total of 563 neurologists provided data for 5299 individuals with Parkinson’s disease; 61% were male, with a mean age of 64 years. Approximately 15% of individuals were deemed to have advanced disease, with significantly more comorbidities, and a poorer quality of life, than those with non-advanced disease. Overall, the mean annual healthcare resource utilization increased significantly with advancing disease, and resulted in a three-fold difference in the USA and Europe. The main drivers behind the high economic burden included hospitalizations, prescription medications, and indirect costs. Conclusions: People with Parkinson’s disease, and their caregivers, incur a higher economic burden as their disease progresses. Future interventions that can control symptoms or slow disease progression could reduce the burden on people with Parkinson’s disease and their caregivers, whilst also substantially impacting societal costs.
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| 3. |
- Malaty, Irene A., et al.
(författare)
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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
- 2022
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Ingår i: BMC Neurology. - : Springer Science and Business Media LLC. - 1471-2377. ; 22:1
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Tidskriftsartikel (refereegranskat)abstract
- 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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| 4. |
- Riggare, Sara, et al.
(författare)
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Patient-driven N-of-1 in Parkinson's Disease. Lessons Learned from a Placebo-controlled Study of the Effect of Nicotine on Dyskinesia
- 2017
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Ingår i: Methods of information in medicine. - 2511-705X. ; 56:99, s. e123-e128
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: New insights and knowledge in biomedical science often come from observation and experimentation. Methods traditionally used include self-experimentation, case reports, randomised controlled trials, and N-of-1 studies. Technological advances have lead to an increasing number of individuals and patients engaging in self-tracking. We use the term patient-driven N-of-1 for self-tracking performed with the explicit intention to disseminate the results by academic publishing.OBJECTIVES: The aim of the study was to: 1) explore the potential role for patient-driven N-of-1 studies as a tool for improving self-management in Parkinson's disease (PD) using the example of managing levodopa-induced dyskinesia (LID) with nicotine, and 2) based on this example; identify some specific challenges of patient-driven N-of-1 studies.METHODS: We used a placebo controlled patient-driven N-of-1 study with nicotine administered via e-cigarette to treat LID. The first author initiated and conducted the experiment on herself and noted her observations. The evaluations of the potential of N-of-1 for improving self-management of PD as well as the effects of nicotine on dyskinesia were based on the perception of the subject. During the planning and undertaking of the experiment, notes were made to identify challenges specific to patient-driven N-of-1 studies.RESULTS: The subject was able to distinguish a decrease of her LID from nicotine but no effect from placebo. The main challenges of patient-driven N-of-1 studies were identified to be associated with planning of the study, recruiting a suitable research team, making sure the data collection is optimal, analysis of data, and publication of results.CONCLUSIONS: Our study indicates that nicotine administered via e-cigarette may have an effect on levodopa-induced dyskinesia in individual patients with PD. The main contribution is however highlighting the work done by patients on a daily basis for understanding their conditions and conducting self-tracking experiments. More work is needed to further develop methods around patient-driven N-of-1 studies for PD.
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