The direct costs of care were evaluated prospectively in a sample of people with Parkinson's disease (PD) in the United Kingdom in 1998. The subjects were drawn from a random sample of general practitioner practices within a representative sample of 36 Regional Health Authorities and the equivalent. A total of 444 resource use questionnaires with usable data were returned (response rate, 59%). The total mean annual cost of care per patient for all patients by age was 5,993 pounds (9,554 euro, n = 432). Hoehn and Yahr stage significantly (P < 0.001) influenced expenditure by stage as follows: 0 and I, 2,971 pounds (4,736 euro, n = 110); II, pound 3,065 (4,886 euro, n = 89); III, 6,183 pounds (9,857 euro, n = 120); IV, 10,134 pounds (euro;16,155, n = 87); V, 18,358 pounds (29,265 euro, n = 17). National Health Service costs accounted for approximately 38% and social services for 34% of the direct costs of care. Drug expenditure accounted for 24% of overall costs in the <65 years age group and 10% in patients aged >85 years. A move from home to residential care was associated with an approximately 500% cost increase. In conclusion, PD imposes significant direct costs on public services and on individuals. These costs should be taken into account when allocating public funds.
The use of patient reported outcome scales in clinical trials conducted by the pharmaceutical industry has become more widespread in recent years. The use of such outcomes is particularly common for products developed to treat chronic, disabling conditions where the intention is not to cure but to ameliorate symptoms, facilitate functioning or, ultimately, to improve quality of life. In such cases, patient reported evidence is increasingly viewed as an essential complement to traditional clinical evidence for establishing a product's competitive advantage in the marketplace. In a commercial setting, the value of patient reported outcomes is viewed largely in terms of their potential for securing a labelling claim in the USA or inclusion in the summary of product characteristics in Europe. Although, the publication of the recent US Food and Drug Administration guidance makes it difficult for companies to make claims in the USA beyond symptom improvements, the value of these outcomes goes beyond satisfying requirements for a label claim. The European regulatory authorities, payers both in the US and Europe, clinicians and patients all play a part in determining both the availability and the pricing of medicinal products and all have an interest in patient-reported data that go beyond just symptoms. The purpose of the current paper is to highlight the potential added value of patient reported outcome data currently collected and held by the industry for these groups.
Extensive published evidence supports the use of subcutaneously-administered apomorphine as an effective therapy for Parkinson's disease (PD) but to date no consensus recommendations have been available to guide healthcare professionals in the optimal application of apomorphine therapy in clinical practice. This document outlines best-practice recommendations for selecting appropriate candidates for apomorphine intermittent injection (the pen-injection formulation) or apomorphine continuous infusion (the pump formulation), for initiating patients onto therapy and for managing their ongoing treatment. Apomorphine is a suitable therapeutic option for PD patients who experience troublesome 'off' periods despite optimized treatment with oral PD medications. Due to its speed of onset, apomorphine injection is particularly suited to those patients requiring rapid, reliable relief of both unpredictable and predictable 'off' periods, those who require reliable and fast relief when anticipating an 'off', those with levodopa absorption or gastric emptying problems resulting in delayed or failed 'on', or for rapid relief of early morning dystonia or akinesia. Apomorphine infusion(1) is suited for patients whose 'off' periods can no longer be adequately controlled by standard oral PD treatment or for those in whom rescue doses of apomorphine injection are effective but either needed too frequently (more than 4-6 times per day), or are associated with increasing dyskinesia. In addition to treating motor fluctuations, there is evidence that apomorphine infusion may be effective for the management of specific non-motor symptoms of PD associated with 'off' periods. Apomorphine infusion is less invasive than other non-oral treatment options for advancing disease, intrajejunal levodopa infusion and deep-brain stimulation.
Current management guidelines for the treatment of patients with Parkinson's disease (PD) are limited due to the lack of knowledge of factors that influence health-related quality of life (HRQL). To assess the HRQL of people with PD, and to systematically identify and evaluate those factors (other than disease severity and medication, which could have an impact), we undertook a cross-sectional, randomized selection, multicenter international survey of patients with PD, caregivers, and clinicians. Face-to-face interviews were conducted with subjects in six countries. Disease severity, medication, and other factors hypothesized to influence HRQL were assessed using a combination of specially developed questionnaires and validated instruments including the Parkinson's Disease Questionnaire-39 (HRQL), Hoehn and Yahr Stage (disease severity), and Beck's Depression Inventory (BDI; depression). Multiple linear regression models were used to demonstrate whether the factors investigated contribute significantly to HRQL. The results obtained indicated that Hoehn and Yahr stage and medication explained only 17.3% of the variability in HRQL of patients with PD, although both were significant (R(2) = 0.173, P < 0.05). Other factors increased the explanatory power to adjusted R(2) = 0.597, with BDI being the most significant predictor of variability in HRQL (adjusted R(2) = 0.582; P < 0.001), followed by "Satisfaction with the explanation of the condition at diagnosis" and "Current feelings of optimism" (both P < 0.05). These factors, in addition to disease severity and medication, explain 59.7% of the variability in HRQL across the population. In conclusion, depression (as measured by the BDI) in PD, "satisfaction with the explanation of the condition at diagnosis" and "current feelings of optimism" have a significant impact on HRQL. The completion of this initial analysis is the first step towards developing management guidelines that truly influence the HRQL of patients with PD.
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