Multiple Criteria Decision Analysis (MCDA) has emerged as a methodology for Health Technology Assessment (HTA). However, limited empirical evidence is available on its use by decision-makers; where ...available, it only comes from single-setting exercises, while cross-country comparative studies are unavailable. This study applies the Advance Value Framework (AVF), an MCDA methodology for HTA based on multi-attribute value theory, through a series of case studies with decision-makers in four countries, to explore its feasibility and compare decision-makers' value preferences and results.
The AVF was applied in the evaluation of three drugs for metastatic, castrate resistant, prostate cancer (abiraterone, cabazitaxel and enzalutamide) in the post-chemotherapy indication. Decision conferences were organised in four European countries in collaboration with their HTA or health insurance organisations by involving relevant assessors and experts: Sweden (TLV), Andalusia/Spain (AETSA), Poland (AOTMiT) and Belgium (INAMI-RIZIV). Participants' value preferences, including performance scoring and criteria weighting, were elicited through a facilitated decision-analysis modelling approach using the MACBETH technique.
Between 6 and 11 criteria were included in each jurisdiction's value model, allocated across four criteria domains; Therapeutic Benefit criteria consistently ranked first in relative importance across all countries. Consistent drug rankings were observed in all settings, with enzalutamide generating the highest overall weighted preference value (WPV) score, followed by abiraterone and cabazitaxel. Dividing drugs' overall WPV scores by their costs produced the lowest “cost per unit of value” for enzalutamide, followed by abiraterone and cabazitaxel. These results come in contrast with the actual country HTA recommendations and pricing decisions.
Overall, although some differences in value preferences were observed between countries, drug rankings remained the same. The MCDA methodology employed could act as a decision support tool in HTA, due to the transparency in the construction of value preferences in a collaborative manner.
•An MCDA value framework was piloted with HTA decision-makers in four EU countries.•The value drivers of three prostate cancer drugs and their importance were analysed.•Decision-maker value preferences were elicited during four decision conferences.•Value rankings of treatment options were similar and consistent across countries.•The proposed MCDA methodology has prospects to act as a decision support tool.
Coral morphology has important implications across scales, from differences in physiology, to the environments they are found, through to their role as ecosystem engineers. However, quantifying ...morphology across taxa is difficult, and so morphological variation is typically captured via coarse growth form categories (e.g. arborescent and massive). In this study, we develop an approach for quantifying coral morphology by identifying continuous three-dimensional shape variables. To do so, we contrast six variables estimated from 152 laser scans of coral colonies that ranged across seven growth form categories and three orders of magnitude of size. We found that 88% of the variation in shape was captured by two principal components. The main component was variation in volume compactness (
cf
. convexity), and the second component was a trade-off between surface complexity and top-heaviness. Variation in volume compactness also limited variation along the second axis, where surface complexity and top-heaviness ranged more freely when compactness was low. Traditional growth form categories occupied distinct regions within this morphospace; however, these regions overlapped due to scaling of shape variables with colony size. Nonetheless, with four of the shape variables we were able to predict traditional growth form categories with 70 to 95% accuracy, suggesting that the continuous variables captured most of the qualitative variations implied by these growth forms. Distilling coral morphology into continuous variables that capture shape variation will allow for better tests of the mechanisms that govern coral biology, ecology and ecosystem services such as reef building and provision of habitat.
Innovative care models such as public-private partnerships (PPPs) may help meet the challenge of providing cost-effective high-quality care for the steadily growing and complex chronic kidney disease ...population since they combine the expertise and efficiency of a specialized dialysis provider with the population care approach of a public entity. We report the five-years main clinical outcomes of a population of patients treated on hemodialysis within a PPP-care model in Italy.
This descriptive retrospective cohort study consisted of all consecutive hemodialysis patients treated in the NephroCare-operated Nephrology and Dialysis unit of the Seriate Hospital in 2012-2016, which exercises a PPP-care model. Clinical and treatment information was obtained from the European Clinical Database. Hospitalization outcomes and cumulative all-cause mortality incidences that accounted for competing risks were calculated.
We included 401 hemodialysis patients (197 prevalent and 204 incident patients) in our study. The mean cohort age and age-adjusted Charlson Comorbidity Index were 67.0 years and 6.7, respectively. Patients were treated with online high-volume hemodiafiltration or high-flux hemodialysis. Parameters of treatment efficiency were above the recommended targets throughout the study period. Patients in the PPP experienced benefits in terms of hospitalization (average number of hospital admissions/patient-year: 0.79 and 1.13 for prevalent and incident patients, respectively; average length of hospitalization: 8.9 days for both groups) and had low cumulative all-cause mortality rates (12 months: 10.6 and 7.8%, 5 years: 42.0 and 35.9%, for prevalent and incident patients, respectively).
Results of our descriptive study suggest that hemodialysis patients treated within a PPP-care model framework received care complying with recommended treatment targets and may benefit in terms of hospitalization and mortality outcomes.
ObjectiveTo update the Cochrane review comparing the effects of home-based and supervised centre-based cardiac rehabilitation (CR) on mortality and morbidity, quality of life, and modifiable cardiac ...risk factors in patients with heart disease.MethodsSystematic review and meta-analysis. The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO and CINAHL were searched up to October 2014, without language restriction. Randomised trials comparing home-based and centre-based CR programmes in adults with myocardial infarction, angina, heart failure or who had undergone coronary revascularisation were included.Results17 studies with 2172 patients were included. No difference was seen between home-based and centre-based CR in terms of: mortality (relative risk (RR) 0.79, 95% CI 0.43 to 1.47); cardiac events; exercise capacity (mean difference (MD) −0.10, −0.29 to 0.08); total cholesterol (MD 0.07 mmol/L, −0.24 to 0.11); low-density lipoprotein cholesterol (MD −0.06 mmol/L, −0.27 to 0.15); triglycerides (MD −0.16 mmol/L, −0.38 to 0.07); systolic blood pressure (MD 0.2 mm Hg, −3.4 to 3.8); smoking (RR 0.98, 0.79 to 1.21); health-related quality of life and healthcare costs. Lower high-density lipoprotein cholesterol (MD −0.07 mmol/L, −0.11 to −0.03, p=0.001) and lower diastolic blood pressure (MD −1.9 mm Hg, −0.8 to −3.0, p=0.009) were observed in centre-based participants. Home-based CR was associated with slightly higher adherence (RR 1.04, 95% CI 1.01 to 1.07).ConclusionsHome-based and centre-based CR provide similar benefits in terms of clinical and health-related quality of life outcomes at equivalent cost for those with heart failure and following myocardial infarction and revascularisation.
Coral reefs are facing severe threats and are at risk of accelerated decline due to climate change‐induced changes in their environment. Ongoing efforts to understand the mechanisms of coral response ...to warming rely on multiple sources of temperature data. Yet, it remains uncertain whether the Sea Surface Temperature (SST) data used for coral reef studies are consistent among different data products, despite potential implications for conservation. A better understanding of the consistency among the different SST data applied to coral reefs may facilitate the fusion of data into a standard product. This will improve monitoring and understanding of the impact of global warming on coral reefs. Four types of SST data across North‐Western and South‐Western Australia are compared to assess their differences and ability to observe high thermal stress during historical coral bleaching events. The four SST data sources included those derived from Global Circulation Models, NOAA CoralTemp SST product, ESA CCI SST product, and coral core derived SST. Coral bleaching risk indicators, Degree Heating Week (DHW), and Degree Heating Month (DHM) were calculated using these sources and compared for consistency. DHW and DHM were inconsistent among data sets and did not accurately reflect high thermal stress metrics during moderate and severe bleaching events. Some reefs did not experience bleaching in spite of high DHWs and DHMs, suggesting a mismatch in data scales, or perhaps other oceanographic factors and coral adaptation. By exploring the differences and similarities among these four data sources, this study highlights the need to compare existing indicators of thermal stress from different data sets.
Plain Language Summary
Climate change and warming have resulted in global coral bleaching events, severely compromising our environment's health. Monitoring the changes in ocean temperatures around them is essential to maximizing our efforts to protect them. Different ocean temperature data products exist and are being used without understanding their differences. To highlight these differences, the present study compares historical warming from climate models and remote and in situ sensors and known bleaching events on five reefs across Western Australia.
Key Points
Temperature data sources did not provide consistent risk indicators for coral bleaching
Across five reefs, coral bleaching risk indicators differed in their ability to predict the observed coral bleaching events
Temperature data in daily and monthly temporal resolutions differed in the accuracy of coral bleaching risk indicators
In machining of multi-layer metal materials used frequently for the manufacture of transfer sheet-metal forming tools, the cutting edge is often damaged because of cutting force peaks. Therefore, a ...neuro-mechanistic model, presented in this paper, has been created for accurate prediction of cutting forces in helical end milling of multidirectional layered materials. The generalized model created takes into account the complex geometry of the helical end milling cutter, the instantaneous chip thickness and the direction of depositing of the individual layer of the multidirectional layered material considered in the calculation through predicted specific cutting forces. For the prediction of specific cutting forces for individual layers a neural network is incorporated in the model. The comparison with experimental data shows that the model predicts accurately the flow of cutting force in milling of multidirectional layered metal materials for any combination of cutting parameters, tool engagement angle and directions of depositing three layers of material. The predicted cutting force values agree well with the values obtained, the maximum error of predicted cutting forces is 16.1 % for all comparison tests performed.
Abstract
Background
Patients who return to dialysis after kidney allograft failure (KAF) are classically considered to have lower survival rates than their transplant-naïve incident dialysis ...counterparts. However, this observation in previous comparisons could be due to poor matching between the two populations.
Methods
To compare survival rates between patients who returned to haemodialysis (HD) after KAF versus transplant-naïve incident HD patients, we performed a retrospective study using the EuCliD® database (European Clinical Database) that collects data from Fresenius Medical Care (FMC) outpatient HD facilities in Spain. Propensity score matching (PSM) was performed to homogenize both populations.
Results
This study included 5216 patients from 65 different FMC clinics between 2009 and 2014. Naïve incident HD patients were mostly male, older, comorbid and more commonly had catheters as vascular access. During the study follow-up, 3915 patients exited, of whom 1534 died. The mean survival time for the entire cohort was 4.86 years 95% confidence interval (CI) 4.78–4.94. Univariate Cox analysis indicated higher mortality risk among transplant-naïve incident HD patients hazard ratio (HR) 1.728; 95% CI 1.35–2.21; P < 0.001). However, this difference was no longer significant after multivariate adjustment. After applying PSM to minimize the bias due to indication issue, we obtained an adjusted population composed of 480 naïve and 240 KAF patients. The results analysing the PSM-adjusted cohort confirmed similar survival in both cohorts (log-rank, 3.34; P = 0.068; HR 1.382; 95% CI 0.97–1.95; P = 0.069).
Conclusions
When comparing properly matched patient groups, patients who return to HD after KAF present similar survival than survival than transplant-naïve incident patients.
Cell‐mediated immunity assays could be valuable for risk assessment of organ donors, but no data exist on their feasibility in deceased donors. In this study, 105 deceased donors (52.3 ± 16.9 years) ...were screened at the time of organ procurement. Pathogen‐specific stimulation was performed using a cytomegalovirus (CMV) lysate, tuberculin (purified protein derivative PPD) and soluble Mycobacterium tuberculosis‐specific ESAT‐6/CFP‐10 proteins in combination with an in‐house fluorescence‐activated cell sorting (FACS) assay or commercial assay formats (QuantiFERON‐CMV/TB for ELISA, T‐SPOT.TB for ELISPOT). CMV‐IgG antibody titers were determined as gold standard for CMV infection; 51.4% of samples were CMV seropositive. Indeterminate results were observed in 47.6% of ELISA, 12.5% of FACS and 0% of ELISPOT assays. Agreement with serology was highest for FACS (95.6%, κ = 0.91), followed by ELISPOT (84.0%, κ = 0.68) and ELISA (80.0%, κ = 0.60). Agreement between ELISA and serology increased if the CMV lysate was used as stimulus (96.7%, κ = 0.92). Among the T cell assays, agreement between ELISPOT and FACS was highest (κ = 0.70). PPD‐positive results among valid samples differed between assays (26.5% for ELISA, 23.1% for FACS and 50.5% for ELISPOT); 2.0% were QuantiFERON‐TB positive, 3.3% were ESAT‐6/CFP‐10‐positive in FACS and 13.4% were positive in the T‐SPOT.TB assay. In conclusion, cellular immunity may be analyzed from samples of deceased donors, although the assays differ in the rate of positivity and indeterminate results.
The authors characterize the performance characteristics of currently available cell‐mediated immunity assays in samples from deceased donors, and show that these assays may be included in donor screening, but differ in the rate of positivity and indeterminate results.
It has been a long-standing clinical concern that haemodialysis (HD) patients on afternoon shifts (ASs) are more prone to protein-energy wasting (PEW) than those on morning shifts (MSs), as their ...dialysis scheme and post-dialysis symptoms may interfere with meal intake. We evaluated the effect of time of day of HD on the evolution of body composition changes and PEW surrogates.
We conducted a retrospective study among 9.963 incident HD patients treated in NephroCare centres (2011-16); data were routinely collected in the European Clinical Database. The course of multi-frequency bioimpedance determined lean and fat tissue indices (LTI and FTI) between patients in MSs/ASs over 2 years were compared with linear mixed models. Secondary PEW indicators were body mass index, albumin, creatinine index and normalized protein catabolic rate. Models included fixed (age, sex, vascular access and diabetes mellitus) and random effects (country and patient).
Mean baseline LTI and FTI were comparable between MSs (LTI: 12.5 ± 2.9 kg/m2 and FTI: 13.7 ± 6.0 kg/m2) and ASs (LTI: 12.4 ± 2.9 kg/m2 and FTI: 13.2 ± 6.1 kg/m2). During follow-up, LTI decreased and FTI increased similarly, with a mean absolute change (baseline to 24 months) of -0.3 kg/m2 for LTI and +1.0 kg/m2 for FTI. The course of these malnutrition indicators did not differ between dialysis shifts (P for interaction ≥0.10). We also did not observe differences between groups for secondary PEW indicators.
This study suggests that a dialysis shift in the morning or in the afternoon does not impact the long-term nutritional status of HD patients. Regardless of time of day of HD, patients progressively lose muscle mass and increase body fat.
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