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Costs, quality of life and cost-effectiveness of open and arthroscopic repair for rotator cuff tears : economic evaluation alongside the UKUFF trial

FUNDING & ACKNOWLEDGEMENTS This project was funded by the NIHR Health Technology Assessment programme (project number 05/47/02) and is published in full in Health Technology Assessment; Vol. 19, No. 80. Further information available at: http://www.nets.nihr.ac.uk/projects/hta/054702 This paper presents independent research commissioned by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, MRC, CCF, NETSCC, the HTA programme or the Department of Health. Due to the confidential nature of the trial data supporting this publication not all of the data can be made accessible to other researchers. Please contact the UKUFF study principal investigator Andrew Carr (andrew.carr@ndorms.ox.ac.uk) for more information. The authors wish to thank the UKUFF trial collaborators for their contribution in managing the conduct of the trial, and for their comments on the interim economic results: Marion Campbell and Hannah Bruhn (Centre for Healthcare Randomised Trials, HSRU, University of Aberdeen), Jonathan Rees MD and David Beard (NDORMS, University of Oxford; NIHR Oxford Biomedical Research Centre), Jane Moser (NDORMS, University of Oxford), Raymond Fitzpatrick and Jill Dawson (NDPH, University of Oxford).

Impact of Hemoglobin Levels and Anemia on Mortality in Acute Stroke : Analysis of UK Regional Registry Data, Systematic Review, and Meta‐Analysis

Funding Sources The NNUH Stroke and TIA Register is maintained by the NNUH NHS Foundation Trust Stroke Services and data management for this study is supported by the NNUH Research and Development Department through Research Capability Funds.

State-space modelling of geolocation data reveals sex differences in the use of management areas by breeding northern fulmars

We thank Orkney Islands Council for access to Eynhallow and Talisman Energy (UK) Ltd and Marine Scotland for fieldwork and equipment support. Handling and tagging of fulmars was conducted under licences from the British Trust for Ornithology and the UK Home Office. EE was funded by a Marine Alliance for Science and Technology for Scotland/University of Aberdeen College of Life Sciences and Medicine studentship and LQ was supported by a NERC Studentship. Thanks also to the many colleagues who assisted with fieldwork during the project, and to Helen Bailey and Arliss Winship for advice on implementing the state-space model.

Lack of effect of lowering LDL cholesterol on cancer: meta-analysis of individual data from 175,000 people in 27 randomised trials of statin therapy

Background: Statin therapy reduces the risk of occlusive vascular events, but uncertainty remains about potential effects on cancer. We sought to provide a detailed assessment of any effects on cancer of lowering LDL cholesterol (LDL-C) with a statin using individual patient records from 175,000 patients in 27 large-scale statin trials. Methods and Findings: Individual records of 134,537 participants in 22 randomised trials of statin versus control (median duration 4.8 years) and 39,612 participants in 5 trials of more intensive versus less intensive statin therapy (median duration 5.1 years) were obtained. Reducing LDL-C with a statin for about 5 years had no effect on newly diagnosed cancer or on death from such cancers in either the trials of statin versus control (cancer incidence: 3755 [1.4% per year [py]] versus 3738 [1.4% py], RR 1.00 [95% CI 0.96-1.05]; cancer mortality: 1365 [0.5% py] versus 1358 [0.5% py], RR 1.00 [95% CI 0.93-1.08]) or in the trials of more versus less statin (cancer incidence: 1466 [1.6% py] vs 1472 [1.6% py], RR 1.00 [95% CI 0.93-1.07]; cancer mortality: 447 [0.5% py] versus 481 [0.5% py], RR 0.93 [95% CI 0.82-1.06]). Moreover, there was no evidence of any effect of reducing LDL-C with statin therapy on cancer incidence or mortality at any of 23 individual categories of sites, with increasing years of treatment, for any individual statin, or in any given subgroup. In particular, among individuals with low baseline LDL-C (<2 mmol/L), there was no evidence that further LDL-C reduction (from about 1.7 to 1.3 mmol/L) increased cancer risk (381 [1.6% py] versus 408 [1.7% py]; RR 0.92 [99% CI 0.76-1.10]). Conclusions: In 27 randomised trials, a median of five years of statin therapy had no effect on the incidence of, or mortality from, any type of cancer (or the aggregate of all cancer).

Safety and efficacy of ledipasvir-sofosbuvir in black patients with hepatitis C virus infection: A retrospective analysis of phase 3 data.

UNLABELLED: Black patients chronically infected with genotype 1 hepatitis C virus (HCV) have historically had lower rates of response to interferon-based treatment than patients of other races. In the phase 3 ION program, the single-tablet regimen of the NS5A inhibitor ledipasvir and NS5B nucleotide polymerase inhibitor sofosbuvir was shown to be safe and highly effective in the general population. The aim of this study was to evaluate the safety and efficacy of ledipasvir/sofosbuvir in black patients using data from the three open-label ION clinical trials, which evaluated the safety and efficacy of 8, 12, and 24 weeks of ledipasvir/sofosbuvir with or without ribavirin for the treatment of treatment-naïve and treatment-experienced patients with genotype 1 HCV, including those with compensated cirrhosis. The primary endpoint was sustained virologic response at 12 weeks after the end of therapy (SVR12). For our analysis, rates of SVR12, treatment-emergent adverse events, and graded laboratory abnormalities were analyzed in black versus non-black patients. Of the 1949 patients evaluated, 308 (16%) were black. On average, black patients were older, had higher body mass index, were more likely to be IL28B non-CC, and had a lower serum alanine aminotransferase at baseline than non-black patients. Overall, 95% of black and 97% of non-black patients achieved SVR12. The rate of relapse was 3% in black patients as compared with 2% in non-black patients. The most common adverse events included fatigue, headache, nausea, and insomnia. The majority of adverse events occurred more frequently in the ribavirin-containing arms of the studies. No differences were observed in overall safety by race. CONCLUSION: A once-daily dosage of ledipasvir/sofosbuvir was similarly effective in black and non-black patients with genotype 1 HCV infection. The addition of ribavirin did not appear to increase SVR12 but was associated with higher rates of adverse events.

Modelled niche centres and niche breadths of open ocean phytoplankton taxa

This data contains realized ecological niche estimates of phytoplankton taxa within the mixed layer of the open ocean. The estimates are based on data from the MARine Ecosystem DATa (MAREDAT) initiative, and cover five phytoplankton functional types: coccolithophores (40 species), diatoms (87 species), diazotrophs (two genera), Phaeocystis (two species) and picophytoplankton (two genera). Considered as major niche dimensions were temperature (°C), mixed layer depth (MLD; m), nitrate concentration (µmoles/L), mean photosynthetically active radiation in the mixed layer (MLPAR; µmoles/m**2/s), salinity, and the excess of phosphate versus nitrate relative to the Redfield ratio (P*; µmoles/L). For each niche dimension at a time, conditions at presence locations of the taxa were contrasted with conditions in 12 000 randomly sampled points from the open ocean using MaxEnt models. We used the quartiles of the response curves of these models to parameterize realized niche centers and niche breadths: the median (q50) of the response curves was considered to be the niche center and the distance between the lower quartile (q25) and the upper quartile (q75) was used as a rough estimate of niche breadth. We only reported meaningful niche estimates, i.e., estimates based on MaxEnt models that perform significantly better than random, as indicated by an area under the curve (AUC) score significantly larger than 0.5.

Pollen data and pollen-based climate reconstruction for the KTK1 pollen record from Lake Kotokel

In this study a radiocarbon-dated pollen record from Lake Kotokel (52°47' N, 108°07' E, 458 m a.s.l.) located in southern Siberia east of Lake Baikal was used to derive quantitative characteristics of regional vegetation and climate from about 15 kyr BP (1 kyr = 1000 cal. yr) until today. Quantitative reconstruction of the late glacial vegetation and climate dynamics suggests that open steppe and tundra communities predominated in the study area prior to ca. 13.5 kyr BP and again during the Younger Dryas interval, between 12.8 and 11.6 kyr BP. The pollen-based climate reconstruction suggests lower-than-present mean January (~ -38 °C) and July (~ 12 °C) temperatures and annual precipitation (~ 270-300 mm) values during these time intervals. Boreal woodland replaced the primarily open landscape around Kotokel three times at about 14.8-14.7 kyr BP, during the Allerød Interstadial between 13.3-12.8 kyr BP and with the onset of the Holocene interglacial between 11.5 and 10.5 kyr BP, presumably in response to a noticeable increase in precipitation, and in July and January temperatures. The maximal spread of the boreal forest (taiga) communities in the region is associated with a warmer and wetter-than-present climate (Tw ~ 17-18 °C, Tc ~ -19 °C, Pann ~ 500-550 mm) that occurred ca. 10.8-7.3 kyr BP. During this time interval woody vegetation covered more than 50 % of the area within a 21x21 km window around the lake. The pollen-based best modern analogue reconstruction suggests a decrease in woody cover percentages and in all climatic variables about 7-6.5 kyr BP. Our results demonstrate a gradual decrease in precipitation and mean January temperature towards their present-day values in the region around Lake Kotokel since that time.

Data S1. Results of the analyses considering developmental time, supplementary figures and tables & Video S1

Our ability to project the impact of global change on marine ecosystem is limited by our poor understanding on how to predict species sensitivity. For example, the impact of ocean acidification is highly species-specific, even in closely related taxa. The aim of this study was to test the hypothesis that the tolerance range of a given species to decreased pH corresponds to their natural range of exposure. Larvae of the green sea urchin Strongylocentrotus droebachiensis were cultured from fertilization to metamorphic competence (29 days) under a wide range of pH (from pHT = 8.0/pCO2 ~ 480 ?atm to pHT = 6.5/pCO2 ~ 20 000 ?atm) covering present (from pHT 8.7 to 7.6), projected near-future variability (from pHT 8.3 to 7.2) and beyond. Decreasing pH impacted all tested parameters (mortality, symmetry, growth, morphometry and respiration). Development of normal, although showing morphological plasticity, swimming larvae was possible as low as pHT >= 7.0. Within that range, decreasing pH increased mortality and asymmetry and decreased body length (BL) growth rate. Larvae raised at lowered pH and with similar BL had shorter arms and a wider body. Relative to a given BL, respiration rates and stomach volume both increased with decreasing pH suggesting changes in energy budget. At the lowest pHs (pHT <= 6.5), all the tested parameters were strongly negatively affected and no larva survived past 13 days post fertilization. In conclusion, sea urchin larvae appeared to be highly plastic when exposed to decreased pH until a physiological tipping point at pHT = 7.0. However, this plasticity was associated with direct (increased mortality) and indirect (decreased growth) consequences for fitness.

Planktic foraminifera analyses of surface sediments and satellite data in the Canary Islands region

The Canary Islands region occupies a key position with respect to biogeochemical cycles, with the zonal transition from oligotrophic to nutrient-rich waters and the contribution of Saharan dust to the particle flux. We present the distribution of geochemical proxies (TOC, carbonate, d15N, d13Corg, C/N-ratio) and micropaleontological parameters (diatoms, dinoflagellates, foraminifera, pteropods), in 80 surface-sediment samples in order to characterise the influence of coastally upwelled water on the domain of the subtropical gyre. Results of the surface-sediment analyses confirmed the high biomass gradient from the coast to the open ocean inferred from satellite data of surface chlorophyll or SST. The distribution of total dinoflagellate cysts, the planktic foraminifera species Globigerina bulloides, the diatom resting spore Chaetoceros spp., and TOC concentration coincided well with the areas of strong filament production off Cape Ghir and Cape Yubi. The warm-water planktic foraminifera Globigerinoides ruber (white), the diatom Nitzschia spp., and the d15N-values showed the opposite trend with high values in the open ocean. Factor analyses on the planktic foraminifera species distribution indicated three major assemblages in the Canary Islands region that represent the present surface-water conditions from the upwelling influenced region via a mixing area towards the subtropical gyre.

Relative abundance of diatom species in surface samples from the Southern Ocean, major open ocean species

Diatom assemblages from 228 core-top samples were investigated to determine the modern geographic distributions of 10 major open ocean species or species groups in the Atlantic and Indian sectors of the Southern Ocean. Our study gives a more comprehensive view of the relationships between diatom distribution and environmental pressures than previous studies, as our modern database covers a much wider area, and additionally highlights the relationships with sea ice cover and concentration. The 10 species or species categories can mainly be lumped into three groupings. First, a cool open ocean grouping composed of Rhizosolenia pointed group, Thalassiosira gracilis group and Trichotoxon reinboldii with maximum relative abundances occurring within the maximum winter sea-ice edge. Second, a pelagic open ocean grouping composed of Fragilariopsis kerguelensis, Thalassiosira lentiginosa, Thalassiosira oliverana and Thalassiothrix spp. group with maximum occurrences at the Antarctic Polar Front. Third, a warm open ocean grouping with maximum abundances observed within the Polar Front Zone and composed of the Rhizosolenia rounded group, the Thalassionema nitzschioides var. nitzschioides group and the Thalassionema nitzschioides var. lanceolata. Comparisons of the abovementioned 10 species or species groups with modern February sea-surface temperatures and sea-ice duration and concentration reveal species-specific sedimentary distributions regulated both by sea-surface temperatures and sea ice conditions that support the use of diatom remains to reconstruct past variations of these environmental parameters via qualitative and transfer function approaches.

Mesocosm experiment on warming and acidification effects in 2012: Microzooplankton data

Global warming and ocean acidification are among the most important stressors for aquatic ecosystems in the future. To investigate their direct and indirect effects on a near-natural plankton community, a multiple-stressor approach is needed. Hence, we set up mesocosms in a full-factorial design to study the effects of both warming and high CO2 on a Baltic Sea autumn plankton community, concentrating on the impacts on microzooplankton (MZP). MZP abundance, biomass, and species composition were analysed over the course of the experiment. We observed that warming led to a reduced time-lag between the phytoplankton bloom and an MZP biomass maximum. MZP showed a significantly higher growth rate and an earlier biomass peak in the warm treatments while the biomass maximum was not affected. Increased pCO2 did not result in any significant effects on MZP biomass, growth rate, or species composition irrespective of the temperature, nor did we observe any significant interactions between CO2 and temperature. We attribute this to the high tolerance of this estuarine plankton community to fluctuations in pCO2, often resulting in CO2 concentrations higher than the predicted end-of-century concentration for open oceans. In contrast, warming can be expected to directly affect MZP and strengthen its coupling with phytoplankton by enhancing its grazing pressure.

Oceanographic data, oxygen and methane concentrations, and C-CH4 isotope ratios measured at Jaco Scar

Methane (CH4) concentrations and CH4 stable carbon isotopic composition (d13CCH4) were investigated in the water column within Jaco Scar. It is one of several scars formed by massive slides resulting from the subduction of seamounts offshore Costa Rica, a process that can open up structural and stratigraphical pathways for migrating CH4. The release of large amounts of CH4 into the adjacent water column was discovered at the outcropping lowermost sedimentary sequence of the hanging wall in the northwest corner of Jaco Scar, where concentrations reached up to 1,500 nmol L-1. There CH4-rich fluids seeping from the sedimentary sequence stimulate both growth and activity of a dense chemosynthetic community. Additional point sources supplying CH4 at lower concentrations were identified in density layers above and below the main plume from light carbon isotope ratios. The injected CH4 is most likely a mixture of microbial and thermogenic CH4 as suggested by d13CCH4 values between -50 and -62 per mil Vienna Pee Dee Belemnite. This CH4 spreads along isopycnal surfaces throughout the whole area of the scar, and the concentrations decrease due to mixing with ocean water and microbial oxidation. The supply of CH4 appears to be persistent as repeatedly high CH4 concentrations were found within the scar over 6 years. The maximum CH4 concentration and average excess CH4 concentration at Jaco Scar indicate that CH4 seepage from scars might be as significant as seepage from other tectonic structures in the marine realm. Hence, taking into account the global abundance of scars, such structures might constitute a substantial, hitherto unconsidered contribution to natural CH4 sources at the seafloor.

Model simulation output data (CCSM3) related to uplift of Africa and Himalaya/Tibet Plateau and the influence on tropical African vegetation

Hominid evolution in the late Miocene has long been hypothesized to be linked to the retreat of the tropical rainforest in Africa. One cause for the climatic and vegetation change often considered was uplift of Africa, but also uplift of the Himalaya and the Tibetan Plateau was suggested to have impacted rainfall distribution over Africa. Recent proxy data suggest that in East Africa open grassland habitats were available to the common ancestors of hominins and apes long before their divergence and do not find evidence for a closed rainforest in the late Miocene. We used the coupled global general circulation model CCSM3 including an interactively coupled dynamic vegetation module to investigate the impact of topography on African hydro-climate and vegetation. We performed sensitivity experiments altering elevations of the Himalaya and the Tibetan Plateau as well as of East and Southern Africa. The simulations confirm the dominant impact of African topography for climate and vegetation development of the African tropics. Only a weak influence of prescribed Asian uplift on African climate could be detected. The model simulations show that rainforest coverage of Central Africa is strongly determined by the presence of elevated African topography. In East Africa, despite wetter conditions with lowered African topography, the conditions were not favorable enough to maintain a closed rainforest. A discussion of the results with respect to other model studies indicates a minor importance of vegetation-atmosphere or ocean-atmosphere feedbacks and a large dependence of the simulated vegetation response on the land surface/vegetation model.

Estimate of the (R)USLE rainfall erosivity factor from monthly precipitation data in mainland Spain

The need for continuous recording rain gauges makes it difficult to determine the rainfall erosivity factor (R-factor) of the (R)USLE model in areas without good temporal data coverage. In mainland Spain, the Nature Conservation Institute (ICONA) determined the R-factor at few selected pluviographs, so simple estimates of the R-factor are definitely of great interest. The objectives of this study were: (1) to identify a readily available estimate of the R-factor for mainland Spain; (2) to discuss the applicability of a single (global) estimate based on analysis of regional results; (3) to evaluate the effect of record length on estimate precision and accuracy; and (4) to validate an available regression model developed by ICONA. Four estimators based on monthly precipitation were computed at 74 rainfall stations throughout mainland Spain. The regression analysis conducted at a global level clearly showed that modified Fournier index (MFI) ranked first among all assessed indexes. Applicability of this preliminary global model across mainland Spain was evaluated by analyzing regression results obtained at a regional level. It was found that three contiguous regions of eastern Spain (Catalonia, Valencian Community and Murcia) could have a different rainfall erosivity pattern, so a new regression analysis was conducted by dividing mainland Spain into two areas: Eastern Spain and plateau-lowland area. A comparative analysis concluded that the bi-areal regression model based on MFI for a 10-year record length provided a simple, precise and accurate estimate of the R-factor in mainland Spain. Finally, validation of the regression model proposed by ICONA showed that R-ICONA index overpredicted the R-factor by approximately 19%.