The economic benefit of timely, adequate, and adherence to Parkinson's disease treatment: the Value of Treatment Project 2

Background: Parkinson's disease (PD) is a chronic progressive neurological disorder with a high psychosocial and economic burden. As part of the European Brain Council (EBC)-led Value of Treatment project, this study aimed to capture the economic benefit of timely, adequate, and adherence to PD treatment. Methods: The EBC Value of Treatment Initiative combined different stakeholders to identify unmet needs in the patients’ journey according to Rotterdam methodology. The economic evaluation focused on three major topics identified as major gaps: start of treatment; best treatment for advanced disease; and adherence to treatment. Two separate healthcare systems (Germany and the UK) were chosen. Cost-effectiveness was determined by using decision-analytical modelling approaches. Effectiveness was expressed as quality-adjusted life-years (QALYs) gained and incremental cost-effectiveness ratio (ICER). Results: Treatment intervention in PD was found to be cost-effective regardless of the initial health state of the patient receiving the treatment. Cost savings were between -€1000 and −€5400 with 0.10 QALY gain and -€1800 and -€7600 with 0.10 QALY gain for Germany and the UK, respectively. Treatment remains cost-effective within the National Institute for Health and Care Excellence thresholds. Availability of adequate treatment to more patients was also found to be cost-effective, with an ICER of €15,000–€32,600 across country settings. Achieving the target adherence to treatment would generate cost-savings of €239,000–€576,000 (Germany) and €917,000–€2,980.000 (UK) for every 1,000 patients treated adequately. Conclusions: The analyses confirmed that timely, adequate, and adherence to PD treatment will not only improve care of the patients but is also cost-effective across healthcare systems. Further studies with a distinct identification of gaps in care are necessary to develop better and affordable care

Socioeconomic impact of restless legs syndrome and inadequate restless legs syndrome management across European settings

Restless legs syndrome (RLS) is one of the most common neurological disorders. It describes an irresistible urge to move the legs, mostly manifested in the evening and at night, which can lead to severe sleep disturbance. As part of the European Brain Council (EBC)-led Value-of-Treatment project, this study aimed at capturing the socioeconomic impact of RLS related to the inadequate diagnosis and treatment across different European healthcare settings. The economic burden of RLS was estimated using the published EBC framework of analysis in three separate European Union healthcare systems (France, Germany, and Italy). The RLS care pathway was mapped to identify the unmet needs of patients. Based on specific patient stories, the economic impact of correctly diagnosing RLS and changing between inadequate and target treatment was calculated using appropriate scenario analysis. RLS proved to be a significant personal and social burden, when epidemiological data, high prevalence of RLS, and its need for treatment are combined. By looking at the savings emerging from the provision of optimal care management (timely and correct diagnosis, evidence-based therapy, avoidance of therapy-related complications such as augmentation), the authors foresee substantial economic savings with the achievement of adequate diagnosis and treatment of RLS. Education about RLS is urgently needed for all subspecialties involved in RLS patient care as well as the general public. Equally important, the search for new causal treatment strategies should be intensified to reduce suffering and substantial societal cost

Beyond clinical trials: extending the role of the clinical research nurse into social care and homeless research

Aim: Clinical research nurses work at the fulcrum of clinical trials with clearly defined roles and responsibilities. In England, the National Institute for Health Research (the main funder of health research) has broadened its scope to encompass social care research. The expectation is that clinical research nurses will expand their skill set to support these new studies, many of which will employ qualitative and mixed methods. This discussion paper explores the challenges of facilitating this clinical academic workforce development through a case study of a homeless health and social care research project. This was one of the first studies to engage clinical research nurses in this new and expanded role. Background: Much of what is known about the research nurse workforce has been generated through studies of clinical trials in oncology. The ‘caring-recruiting’ dichotomy has been used as a heuristic device for identifying workforce issues that can impact on study delivery such as how intense pressure to recruit study participants leads to low job satisfaction. Design: This case study reflects on the authors' experiences of employing a clinical research nurse in a social care research project concerned with the discharge of homeless people from hospital. The ‘caring-recruiting’ dichotomy is used to generate new information about the relationship between workforce development and the successful delivery of social care research. Conclusion: The case study illuminates how social care research can generate different pressures and ethical challenges for research nurses. The time and skill it took to recruit study participants identified as ‘hard to reach’ was suggestive of the need to move beyond performance measures that prioritise recruitment metrics. The need for different types of staff supervision and training was also warranted as supporting study participants who were homeless was often distressing, leading to professional boundary issues. Relevance to workforce development: This study highlights that performance management, training and supervisory arrangements must be tailored to the characteristics of each new study coming onto the portfolio to ensure research nurses are fully supported in this new and expanded role

Interleukin-6, interleukin-1β, and tumor necrosis factor α in menstrual effluents as biomarkers of chronic endometritis.

Objective: To assess the relationship between chronic endometritis (CE) and proin␣ammatory cytokine levels in menstrual ef␣uents and to develop a simple noninvasive test for screening CE. Design: Case-control study. Setting: Academic center. Patient(s): Sixty-four women referred to our center for infertility. Intervention(s): Of␣ce hysteroscopy; endometrial biopsy; collection of menstrual blood at subsequent cycle. Main Outcome Measure(s): Interleukin (IL) 6, IL-1b, and tumor necrosis factor (TNF) a concentrations in menstrual ef␣uents. Result(s): Thirty-sixoutof64infertilewomenhadhistologicallyprovenCE.Theremaining28womenwereincludedascontrols.IL-6, IL-1b, and TNF-a levels were markedly higher in menstrual ef␣uents of women with CE compared with control subjects. Receiver operating characteristic curve analysis revealed a good CE screening capacity for all of the cytokines. The combined evaluation of either IL-6/TNF-a or IL-6/IL-1b increased the diagnostic capacity of the test, which reached a 100% sensitivity and a negative predictive value of 100 when at least one cytokine was found to exceed its cutoff value; it also reached a 100% speci␣city and a positive predictive value of 100 in cases of positivity of both cytokines. Logistic regression analysis con␣rmed the IL-6/TNF-a– based model as a signi␣cant predictor of CE. Conclusion(s): Proin␣ammatorycytokinelevelsareincreasedinmenstrualef␣uentsofwomen with CE. A test dosing IL-6 and TNF-a seems to have a high screening capacity for CE. (Fertil Steril! 2014;101:242–7. !2014 by American Society for Reproductive Medicine.

Chronic Endometritis Due to Common Bacteria Is Prevalent in Women With Recurrent Miscarriage as Confirmed by Improved Pregnancy Outcome After Antibiotic Treatment

Recurrent miscarriage (RM) is defined as 3 or more miscarriages before 20 weeks' pregnancy. In recent years, interest has been focused on chronic endometritis (CE), a subtle inflammation thought to be associated with RM. We aimed to evaluate the relationships between CE and RM. The records of 360 women with unexplained RM were retrospectively analyzed. Data from hysteroscopy, endometrial histology, endometrial culture, and polymerase chain reaction for chlamydia, performed before and after antibiotic treatment for CE, were analyzed. The occurrence of successful pregnancies within 1 year after treatment was also evaluated. Results showed that 208 (57.8%) women with RM showed CE at hysteroscopy; 190 (91.3%), positive at hysteroscopy, were also positive at histology, and 142 (68.3%) had positive cultures. Common bacteria were found in 110 (77.5%) patients. Mycoplasma and Ureaplasma were found in 36 (25.3%) patients and Chlamydia in 18 patients (12.7%). In 102 (71%) women, antibiogram-based antibiotic treatment normalized hysteroscopy, histology, and cultures (group 1); while in 40 (28.2%) patients, CE was still present at hysteroscopy (group 2). In 16 of the 66 patients positive at hysteroscopy, but not at cultures, the hysteroscopy becomes normal (group 3) after a Centers for Disease Control and Prevention-based therapy; while in 50 women, CE was still present (group 4). One year after treatment, group 1 showed a significantly higher number of pregnancies (78.4%) compared to group 2 (17.5%; P < .001) and group 4 (15.3%; P = .005). The CE is frequent in women with RM. Antibiotic treatment seems to be associated with an improved reproductive outcome

Evaluation of a new imaging software for aortic endograft planning

Objective: The aim of this study was to evaluate a new 3D Workstation workflow (EVAR Assist, Advantage Windows, GE Healthcare, Chalfont, UK) (EA-AW) designed to simplify complex EVAR planning. Patients and methods: All pre-operative computed tomography (CT) scans of patients who underwent repair at our institution of a complex aortic aneurysm using fenestrated endovascular repair (f-EVAR) between January and September 2014, were reviewed. For each patient, imaging analysis (12 measures: aortic diameters and length and "clock position" of visceral artery) was performed on two different workstations: Aquarius (TeraRecon, San Mateo, CA, USA) and EA-AW. According to a standardized protocol, three endovascular surgeons experienced in aortic endograft planning, performed image analyses and data collection independently. We analyzed an internal assessment between observers (on the Aquarius 3DWS) and an external assessment comparing these results with the planning center (PC) data used to custom the fenestrated endografts of the patients enrolled in this study. Finally, we compared both 3DWS data to determine the accuracy and the reproducibility. A p-value &lt; .05 was considered as statistically significant. Complete agreement between operators was defined as 1.0. Results: Intra and inter observer variability (interclass correlation coefficients - ICC: 0.81- .091) was very low and confirmed the reliability of our planners. The ICC comparison between EA-AW and Aquarius was excellent (&gt; 0.8 for both), thus confirming the reproducibility and reliability of the new EA-AW application. Aortic and iliac necks diameters and lengths were similarly reported with both workstations. In our study, the mean difference in distance and orientation evaluation of target vessels evaluated by the two workstations was marginal and has no impact on clinical practice in term of device manufacturing. Conclusions: We showed that complex EVAR planning can be performed with this new dedicated 3D workstation workflow with a good reproducibility