Outcomes Impacting Quality of Life in Advanced Parkinson's Disease Patients Treated with Levodopa-Carbidopa Intestinal Gel

BACKGROUND: It is believed that motor symptoms, including dyskinesia, and non-motor symptoms impact health-related quality of life (HRQoL) in patients with Parkinson’s disease (PD), and that improvements in these metrics are correlated. OBJECTIVE: Investigate the relationship between HRQoL and measures of PD severity and treatment efficacy, including motor and non-motor symptoms. METHODS: This was a planned investigation of an international, prospective, single-arm, post-marketing observational study of the long-term effectiveness of levodopa-carbidopa intestinal gel (LCIG) in patients with advanced PD. Pearson correlation coefficients (PCC) were calculated for baseline and change from baseline at 12 months between HRQoL and motor and non-motor symptoms. RESULTS: A total of 195 patients were included. At baseline, HRQoL was moderately positively correlated with Activities of Daily Living (UPDRS II, PCC = 0.44), non-motor symptoms (0.48), and measures of sleep (0.50 and 0.40); all p < 0.001. After 12 months of treatment with LCIG, improvements in HRQoL were moderately positively correlated with improvement from baseline in non-motor symptoms (PCC = 0.42), sleep (0.54), and daytime sleepiness (0.40; all p < 0.001), and weakly correlated with improvement in dyskinesia signs and symptoms (PCC = 0.23; p = 0.011). Improvement in HRQoL was not correlated with improvements in OFF time or dyskinesia time. CONCLUSION: Both at baseline and for change from baseline at 12 months, HRQoL was correlated with baseline and change from baseline in dyskinesia, Activities of Daily Living, and non-motor symptoms, including sleep; but not with baseline or change in OFF time

Lean Construction as an Operations Strategy

ABSTRACT All companies have an operations strategy; a pattern of decisions made in operations with the purpose to support the business strategy. Lean Construction can be seen as an operations strategy. The aim of this research is to present the generic decision categories in an operations strategy and discuss their characteristics in contrast to the Lean Construction framework. A literature study identified ten decision categories: process technology, capacity, facilities, vertical integration, human resources, organization, quality, production control, product development, and performance measurement. Data was collected through in-depth interviews with managers on the tactical level at three construction companies with a Lean implementation. The results indicate that Lean construction companies emphasize quality, production planning, and vertical integration in their operations strategy. Facilities, process technology, capacity, and organization receive less attention. Quality, production planning, and vertical integration are keywords also in Lean Construction, while it is intriguing that organization receives little attention. Facilities, process technology, and capacity are ever changing between construction projects and are candidates for decision categories that could be less relevant for formulating an operations strategy in construction

Pharmaceutical Restrictions: Possible Effect on Patient/Physician Buy-In of Disease Management Programs

Restrictions on the use of pharmaceuticals (such as those for low molecular weight heparins) are commonly imposed by healthcare organizations to combat rising health care costs. These restrictions can be system-based which are established by imposing specific coverage policies by insurance companies and payors or can be patient-based which are those that limit certain therapeutic agents to specified patient populations. Disease management (DM) programs are implemented by healthcare organizations to improve patient care while utilizing resources efficiently. From a payor perspective, restricted use of pharmaceuticals would conform to the goals of DM. However, from a practitioner's perspective, restrictions on the use of medications could sometimes be viewed as conflicting with their goal of providing appropriate patient care. Formularies and prior-authorization programs may sometimes impede physicians' clinical autonomy and may hinder physicians' willingness to participate in DM protocols with such drug restrictions. Furthermore, direct-to-patient advertisements and patient education are encouraging patients to participate actively in the drug selection process. When pharmaceutical restrictions prevent patients from receiving their drug of choice, patients may perceive that their treatment is suboptimal and unfavorable. Despite implementing a fine disease management protocol, imposing rigid drug-use restrictions could hinder physicians' and patients' buy-in of DM programs.Disease management programmes, Healthcare expenditure, Pharmacoeconomics

Functional Impairment, Healthcare Costs and the Prevalence of Institutionalisation in Patients with Alzheimer's Disease and Other Dementias

Introduction: The progressive decline in functional status for patients with Alzheimer's disease and other dementias (ADOD) is well documented. However, there is limited information on the economic benefits of interventions improving functional status in an ADOD population. This study estimated the relationship between the degree of functional impairment in patients with ADOD and their healthcare costs and prevalence of institutionalisation. Methods: Retrospective cross-sectional analyses of the Medicare Current Beneficiary Survey (MCBS) were performed. A nationally representative sample of Medicare beneficiaries with ADOD was identified from the 1995-8 waves of the MCBS (n = 3138): 34% in the community, 57% institutionalised and 9% residing in both settings during the year. Three measures of functioning were used: the number of activities of daily living (ADLs) and independent ADLs (IADLs) impaired; an index summarising number and severity of ADL and IADL impairments; and the Katz Index of ADLs. Healthcare costs included costs for all healthcare services received in all settings, regardless of whether they were covered by insurance or paid out of pocket. The relationships between each measure of impairment and healthcare costs and prevalence of institutionalisation were estimated using linear and logistic regression. Results: Healthcare costs (1995-8 values) for all ADOD patients increased by $US1958 (p_Alzheimer's-disease, Cost-analysis, Dementia

The Native Bacterioplankton Community in the Central Baltic Sea Is Influenced by Freshwater Bacterial Species▿ †

The Baltic Sea is one of the largest brackish environments on Earth. Despite extensive knowledge about food web interactions and pelagic ecosystem functioning, information about the bacterial community composition in the Baltic Sea is scarce. We hypothesized that due to the eutrophic low-salinity environment and the long water residence time (>5 years), the bacterioplankton community from the Baltic proper shows a native “brackish” composition influenced by both freshwater and marine phylotypes. The bacterial community composition in surface water (3-m depth) was examined at a single station throughout a full year. Denaturing gradient gel electrophoresis (DGGE) showed that the community composition changed over the year. Further, it indicated that at the four extensive samplings (16S rRNA gene clone libraries and bacterial isolates from low- and high-nutrient agar plates and seawater cultures), different bacterial assemblages associated with different environmental conditions were present. Overall, the sequencing of 26 DGGE bands, 160 clones, 209 plate isolates, and 9 dilution culture isolates showed that the bacterial assemblage in surface waters of the central Baltic Sea was dominated by Bacteroidetes but exhibited a pronounced influence of typical freshwater phylogenetic groups within Actinobacteria, Verrucomicrobia, and Betaproteobacteria and a lack of typical marine taxa. This first comprehensive analysis of bacterial community composition in the central Baltic Sea points to the existence of an autochthonous estuarine community uniquely adapted to the environmental conditions prevailing in this brackish environment

Cost Effectiveness of Once-Daily Oral Chelation Therapy with Deferasirox versus Infusional Deferoxamine in Transfusion-Dependent Thalassaemia Patients: US Healthcare System Perspective

Background: Deferasirox is a recently approved once-daily oral iron chelator that has been shown to reduce liver iron concentrations and serum ferritin levels to a similar extent as infusional deferoxamine. Objective: To determine the cost effectiveness of deferasirox versus deferoxamine in patients with beta-thalassaemia major from a US healthcare system perspective. Methods: A Markov model was used to estimate the total additional lifetime costs and QALYs gained with deferasirox versus deferoxamine in patients with beta-thalassaemia major and chronic iron overload from blood transfusions. Patients were assumed to be 3 years of age at initiation of chelation therapy and to receive prescribed dosages of deferasirox and deferoxamine that have been shown to be similarly effective in such patients. Compliance with chelation therapy and probabilities of iron overload-related cardiac disease and death by degree of compliance were estimated using data from published studies. Costs ($US, year 2006 values) of deferoxamine administration and iron overload-related cardiac disease were based on analyses of health insurance claims of transfusion-dependent thalassaemia patients. Utilities were based on a study of patient preferences for oral versus infusional chelation therapy, as well as published literature. Probabilistic and deterministic sensitivity analyses were employed to examine the robustness of the results to key assumptions. Results: Deferasirox resulted in a gain of 4.5 QALYs per patient at an additional expected lifetime cost of$US126_018 per patient; the cost per QALY gained was $US28_255. The cost effectiveness of deferasirox versus deferoxamine was sensitive to the estimated costs of deferoxamine administration and the quality-of-life benefit associated with oral versus infusional therapy. Cost effectiveness was also relatively sensitive to the equivalent daily dose of deferasirox, and the unit costs of deferasirox and deferoxamine, and was more favourable in younger patients. Conclusion: Results of this analysis of the cost effectiveness of oral deferasirox versus infusional deferoxamine suggest that deferasirox is a cost effective iron chelator from a US healthcare perspective.Children, Cost-utility, Deferasirox, Deferoxamine, Iron-overload, Research-and-development, Thalassaemia

Treatment Interruptions and Non-Adherence with Imatinib and Associated Healthcare Costs: A Retrospective Analysis among Managed Care Patients with Chronic Myelogenous Leukaemia

Objectives: Identify treatment interruptions and non-adherence with imatinib; examine the clinical and patient characteristics related to treatment interruptions and non-adherence; and estimate the association between treatment interruptions and non-adherence with imatinib and healthcare costs for US managed care patients with chronic myeloid leukaemia (CML). Methods: This retrospective analysis utilised electronic healthcare claims data from a US managed care provider. Adult patients with CML (as determined by International Classification of Diseases, ninth revision, Clinical Modification [ICD-9-CM] diagnosis code) were identified who began treatment with imatinib from 1 June 2001 through 31 March 2004. Treatment interruptions (i.e. failure to refill imatinib within 30 days from the run-out date of the prior prescription) were identified during the 12-month follow-up period. Medication possession ratio (MPR), calculated as total days' supply of imatinib divided by 365, was also examined. Healthcare costs (i.e. paid amounts for all prescription medications and medical services received, including health plan and patient liability) were examined in three ways: (i) total healthcare costs; (ii) total healthcare costs exclusive of imatinib costs; and (iii) total medical costs. All costs were converted to $US (2004 values) using the medical component of the Consumer Price Index. MPR was modelled using ordinary least squares regression. Presence of treatment interruptions was modelled using logistic regression. The association between MPR and healthcare costs was estimated using a generalised linear model specified with a gamma error distribution and a log link. All models included adjustment for age, gender, number of concomitant medications, starting dose of imatinib and cancer complexity. Results: A total of 267 patients were identified. Average age was approximately 50 years, and 43% were women. Mean MPR was 77.7%, with 31% of patients having a treatment interruption. However, all of these patients resumed imatinib within the study period. In this population, MPR decreased as the number of concomitant medications increased (p_=_0.002), and was lower among women (p_=_0.003), patients with high cancer complexity (p_=_0.003) and patients with a higher starting dose of imatinib (p_=_0.04). Women were approximately twice as likely as men to have a treatment interruption (p_=_0.009), as were patients with a high cancer complexity (p_=_0.03). After adjusting for the aforementioned covariates, MPR was found to be inversely associated with healthcare costs excluding imatinib (p_Chronic-myeloid-leukaemia, Cost-analysis, Imatinib, Patient-compliance, Resource-use