Latarjet Procedure: Biomechanical Evaluation of 2 Screw Coracoid Fixation.

BACKGROUND: Coracoid nonunion is a relevant complication following the Latarjet procedure and is influenced by multiple factors, including the method of graft fixation. AIMS: The purpose of this study was to evaluate and characterize the biomechanical properties of various two-screw fixation constructs used for coracoid graft fixation in the Latarjet procedure. METHODS: Forty model scapulae (Sawbones Inc., Vashon, WA, USA) were used for this study. A 15 percent anterior inferior glenoid bone defect was created. The coracoid was osteotomized at the juncture of the vertical and horizontal aspects, transferred to the anterior-inferior edge of the glenoid, and fixed with either two 3.5 mm fully threaded cannulated cortical screws (FTCS), two 3.5 mm fully threaded solid cortical screws (FTSS), two 3.5 mm partially threaded cannulated screws (PTCS), or two 4.5 mm partially threaded malleolar screws (MS). Biomechanical testing was performed with an Instron materials testing machine (Instron Corp., Norwood, MA) by applying loads to the lateral aspect of the transferred coracoid graft. The constructs were preconditioned with non-destructive cyclical loading (0-20N) to determine construct stiffness. After 100 cycles of dynamic loading, the construct was loaded to failure to determine ultimate failure load, yield displacement, and mode of failure. RESULTS: All failures were associated with plastic deformation of the screws and coracoid graft fracture. There was a significantly lower initial stiffness for PTCS compared to MS (186±49.3 N/mm vs 280±65.5 N/mm, p=0.01) but no significant differences among the other constructs. There was no difference in ultimate failure load (p=0.18) or yield displacement (p=0.05) among constructs. CONCLUSION: Two screw coracoid fixation of the coracoid in a simulated classic Latarjet procedure with 3.5 mm fully threaded cortical and cannulated screws is comparable to 4.5 mm malleolar screws in strength, stiffness, and displacement at failure. On the other hand, partially threaded 3.5 mm cannulated screws provide inferior fixation stiffness and could potentially affect clinical outcomes.

Rapid Precipitation of Ionomers for Stabilization of Polymeric Colloids.

Polymeric colloids have shown potential as "building blocks" in applications ranging from formulations of Pickering emulsions and drug delivery systems to advanced materials, including colloidal crystals and composites. However, for applications requiring tunable properties of charged colloids, obstacles in fabrication can arise through limitations in process scalability and chemical versatility. In this work, the capabilities of flash nanoprecipitation (FNP), a scalable nanoparticle (NP) fabrication technology, are expanded to produce charged polystyrene colloids using sulfonated polystyrene ionomers as a new class of NP stabilizers. Through experimental exploration of formulation parameters, increases in the ionomer content are shown to reduce the particle size, mitigating a significant trade-off between the final particle size and inlet concentration; thus, expanding the processable material throughput of FNP. Further, the degree of sulfonation is found to impact stabilization with optimal performance achieved by selecting ionomers with intermediate (2.45-5.2 mol %) sulfonation. Simulations of single ionomer chains and their arrangement in multicomponent NPs provide molecular insights into the assembly and structure of NPs wherein the partitioning of ionomers to the particle surface depends on the polymer molecular weight and degree of sulfonation. By combining the insights from simulations with diffusion-limited growth kinetics and parametric fits to experimental data, a simple design formulation relation is proposed and validated. This work highlights the potential of ionomer-based stabilizers for controllably producing charged NP dispersions in a scalable manner.

Effects of the polymer glass transition on the stability of nanoparticle dispersions.

In addition to the repulsive and attractive interaction forces described by Derjaguin-Landau-Verwey-Overbeek (DLVO) theory, many charged colloid systems are stabilized by non-DLVO contributions stemming from specific material attributes. Here, we investigate non-DLVO contributions to the stability of polymer colloids stemming from the intra-particle glass transition temperature (Tg). Flash nanoprecipitation is used to fabricate nanoparticles (NPs) from a library of polymers and dispersion stability is studied in the presence of both hydrophilic and hydrophobic salts. When adding KCl, stability undergoes a discontinuous decrease as Tg increases above room temperature, indicating greater stability of rubbery NPs over glassy NPs. Glassy NPs are also found to interact strongly with hydrophobic phosphonium cations (PR4+), yielding charge inversion and intermediate aggregation while rubbery NPs resist ion adsorption. Differences in the lifetime of ionic structuration within mobile surface layers is presented as a potential mechanism underlying the observed phenomenon.

Online clinical pathway for chronic kidney disease management in primary care: a retrospective cohort study.

BACKGROUND: Clinical pathways aim to improve patient care. We sought to determine whether an online chronic kidney disease (CKD) clinical pathway was associated with improvements in CKD management. METHODS: We conducted a retrospective pre/post population-based cohort study using linked health data from Alberta, Canada. We included adults 18 years or older with mean estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2. The primary outcome was measurement of an outpatient urine albumin creatinine ratio (ACR) in a 28-day period, among people without a test in the prior year. Secondary outcomes included use of guideline-recommended drug therapies (angiotensin-converting enzyme inhibitors, angiotensin receptor blockers and statins). RESULTS: The study period spanned October 2010 to March 2017. There were 84 independent 28-day periods (53 pre, 31 post pathway implementation) including 345,058 adults. The population was predominantly female (56%) with median age 77 years; most had category 3A CKD (67%) and hypertension (82%). In adjusted segmented regression models, the increase in the rate of change of ACR testing was greatest in Calgary zone (adjusted OR 1.19 per year, 95% CI 1.16-1.21), where dissemination of the pathway was strongest; this increase was more pronounced in those without diabetes (adjusted OR 1.25 per year, 95% CI 1.21-1.29). Small improvements in guideline-concordant medication use were also observed. CONCLUSIONS: Following implementation of an online CKD clinical pathway, improvements in ACR testing were evident in regions where the pathway was most actively used, particularly among individuals without diabetes.

Can economic incentives increase the use of home dialysis?

There are advantages to home dialysis for patients, and kidney care programs, but use remains low in most countries. Health-care policy-makers have many levers to increase use of home dialysis, one of them being economic incentives. These include how health-care funding is provided to kidney care programs and dialysis facilities; how physicians are remunerated for care of home dialysis patients; and financial incentives-or removal of disincentives-for home dialysis patients. This report is based on a comprehensive literature review summarizing the impact of economic incentives for home dialysis and a workshop that brought together an international group of policy-makers, health economists and home dialysis experts to discuss how economic incentives (or removal of economic disincentives) might be used to increase the use of home dialysis. The results of the literature review and the consensus of workshop participants were that financial incentives to dialysis facilities for home dialysis (for instance, through activity-based funding), particularly in for-profit systems, could lead to a small increase in use of home dialysis. The evidence was less clear on the impact of economic incentives for nephrologists, and participants felt this was less important than a nephrologist workforce in support of home dialysis. Workshop participants felt that patient-borne costs experienced by home dialysis patients were unjust and inequitable, though participants noted that there was no evidence that decreasing patient-borne costs would increase use of home dialysis, even among low-income patients. The use of financial incentives for home dialysis-whether directed at dialysis facilities, nephrologists or patients-is only one part of a high-performing system that seeks to increase use of home dialysis.

Development and implementation of an online clinical pathway for adult chronic kidney disease in primary care: a mixed methods study.

BACKGROUND: Primary care physicians and other primary health care professionals from Alberta, Canada identified a clinical pathway as a potential tool to facilitate uptake of clinical practice guidelines for the diagnosis, management and referral of adults with chronic kidney disease. We describe the development and implementation of a chronic kidney disease clinical pathway (CKD-CP; www.ckdpathway.ca ). METHODS: The CKD-CP was developed and implemented based on the principles of the Knowledge-To-Action Cycle framework. We used a mixed methods approach to identify the usability and feasibility of the CKD-CP. This included individual interviews, an online survey and website analytics, to gather data on barriers and facilitators to use, perceived usefulness and characteristics of users. Results are reported using conventional qualitative content analysis and descriptive statistics. RESULTS: Eighteen individual interviews were conducted with primary care physicians, nephrologists, pharmacists and nurse practitioners to identify themes reflecting both barriers and facilitators to integrating the CKD-CP into clinical practice. Themes identified included: communication, work efficiency and confidence. Of the 159 participants that completed the online survey, the majority (52 %) were first time CKD-CP users. Among those who had previously used the CKD-CP, 94 % agreed or strongly agreed that the pathway was user friendly, provided useful information and increased their knowledge and confidence in the care of patients with CKD. Between November 2014 and July 2015, the CKD-CP website had 10,710 visits, 67 % of which were new visitors. The 3 most frequently visited web pages were home, diagnose and medical management. Canada, Indonesia and the United States were the top 3 countries accessing the website during the 9 month period. CONCLUSIONS: An interactive, online, point-of-care tool for primary care providers can be developed and implemented to assist in the care of patients with CKD. Our findings are important for making refinements to the CKD -CP website via ongoing discussions with end-users and the development team, along with continued dissemination using multiple strategies.

Over half of the far-infrared background light comes from galaxies at z >or= 1.2.

Submillimetre surveys during the past decade have discovered a population of luminous, high-redshift, dusty starburst galaxies. In the redshift range 1 or= 1.2 accounting for 70% of it. As expected, at the longest wavelengths the signal is dominated by ultraluminous galaxies at z > 1.

The effect of citrate dialysate on intradialytic heparin dose in haemodialysis patients: study design of a randomised controlled trial.

BACKGROUND: Unfractionated heparin is the most common anticoagulant used in haemodialysis (HD), although it has many potential adverse effects. Citrate dialysate (CD) has an anticoagulant effect which may allow reduction in cumulative heparin dose (CHD) compared to standard acetate dialysate (AD). METHODS: This double-blinded, randomised, cross-over trial of chronic haemodialysis patients determines if CD allows reduction in CHD during HD compared with AD. After enrolment, intradialytic heparin is minimised during a two-week run-in period using a standardised protocol based on a visual clotting score. Patients still requiring intradialytic heparin after the run-in period are randomised to two weeks of HD with AD followed by two weeks of CD (Sequence 1) or two weeks of HD with CD followed by two weeks of AD (Sequence 2). The primary outcome is the change in CHD with CD compared with AD. Secondary outcomes include metabolic and haemodynamic parameters, and dialysis adequacy. DISCUSSION: This randomised controlled trial will determine the impact of CD compared with AD on CHD during HD. TRIAL REGISTRATION: ClinicalTrials.gov NCT01466959.

An economic evaluation of rt-PA locking solution in dialysis catheters.

In a recent randomized trial, weekly recombinant tissue plasminogen activator (rt-PA), 1 mg per lumen, once per week, and twice-weekly heparin as a locking solution (rt-PA/heparin) resulted in lower risks of hemodialysis catheter malfunction and catheter-related bacteremia compared with thrice-weekly heparin (heparin alone). We collected detailed costs within this trial to determine how choice of locking solution would affect overall health care costs, including the cost of locking solutions and all other relevant medical costs over the course of the 6-month trial. Nonparametric bootstrap estimates were used to derive 95% confidence intervals (CIs) and mean cost differences between the treatment groups. The cost of the locking solution was higher in patients receiving rt-PA/heparin, but this was partially offset by lower costs for managing complications. Overall, the difference in unadjusted mean cost for managing patients with rt-PA/heparin versus heparin alone was Can$323 (95% CI, -$935 to $1581; P=0.62). When the costs were extrapolated over a 1-year time horizon using decision analysis, assuming ongoing rt-PA effectiveness, the overall costs of the strategies were similar. This finding was sensitive to plausible variation in the frequency and cost of managing patients with catheter-related bacteremia, and whether the benefit of rt-PA on catheter-related bacteremia was maintained in the long term. In summary, we noted no significant difference in the mean overall cost of an rt-PA/heparin strategy as a locking solution for catheters compared with thrice-weekly heparin. Cost savings due to a lower risk of hospitalization for catheter-related bacteremia partially offset the increased cost of rt-PA.

A review of a regional primary percutaneous coronary intervention service, with a focus on door to reperfusion times: the 2012 Auckland/Northland experience.

AIMS: Primary percutaneous coronary intervention (PCI) is the optimal management for ST segment elevation myocardial infarction (STEMI) patients. We reviewed the largest primary PCI regional service in New Zealand: the Auckland/Northland service based at Auckland City Hospital, to assess patient management, in particular the door to reperfusion times (DTRTs), and predictors of death in hospital. METHODS: We obtained patient details from a comprehensive prospective database of all primary PCI patients admitted with STEMI from 1/1/12 to 31/12/12 to the Auckland City Hospital cardiac catheterisation laboratory. Of four District Health Boards (DHBs) within the region, two accessed this regional service at all times, and two accessed the Auckland City Hospital cardiac catheterisation laboratory 'after hours': all times except for 08:00 to 16:00 hours on Monday to Friday. RESULTS: A total of 401 adult patients underwent a primary PCI at the Auckland City Hospital Regional centre for a STEMI presentation, over the 12 months period. The median patient age was 61 years, 77% were male. Overall 183 (46%) (95% CI 41, 51) patients achieved a DTRT of < 90 mins, and 266 (66%) (95% CI 61, 71) a DTRT of < 120 mins, with a clear geographical influence to these times. Of 27 patients with direct transfer to the catheter laboratory from the community, the DTRT was < 120 mins in 24 (92%) (95% CI 72, 96) patients. In-hospital mortality was 24 (6%) patients (95% CI 4, 9). CONCLUSIONS: The 2012 Auckland/Northland primary PCI service delivers good outcomes consistent with current Australasian standards. Although geographical isolation complicates door to reperfusion times, these may potentially be improved by more focus on direct transfer to the cardiac catheterisation laboratory, especially directly from the community.

Prevention of dialysis catheter malfunction with recombinant tissue plasminogen activator.

BACKGROUND: The effectiveness of various solutions instilled into the central venous catheter lumens after each hemodialysis session (catheter locking solutions) to decrease the risk of catheter malfunction and bacteremia in patients undergoing hemodialysis is unknown. METHODS: We randomly assigned 225 patients undergoing long-term hemodialysis in whom a central venous catheter had been newly inserted to a catheter-locking regimen of heparin (5000 U per milliliter) three times per week or recombinant tissue plasminogen activator (rt-PA) (1 mg in each lumen) substituted for heparin at the midweek session (with heparin used in the other two sessions). The primary outcome was catheter malfunction, and the secondary outcome was catheter-related bacteremia. The treatment period was 6 months; treatment assignments were concealed from the patients, investigators, and trial personnel. RESULTS: A catheter malfunction occurred in 40 of the 115 patients assigned to heparin only (34.8%) and 22 of the 110 patients assigned to rt-PA (20.0%)--an increase in the risk of catheter malfunction by a factor of almost 2 among patients treated with heparin only as compared with those treated with rt-PA once weekly (hazard ratio, 1.91; 95% confidence interval [CI], 1.13 to 3.22; P = 0.02). Catheter-related bacteremia occurred in 15 patients (13.0%) assigned to heparin only, as compared with 5 (4.5%) assigned to rt-PA (corresponding to 1.37 and 0.40 episodes per 1000 patient-days in the heparin and rt-PA groups, respectively; P = 0.02). The risk of bacteremia from any cause was higher in the heparin group than in the rt-PA group by a factor of 3 (hazard ratio, 3.30; 95% CI, 1.18 to 9.22; P = 0.02). The risk of adverse events, including bleeding, was similar in the two groups. CONCLUSIONS: The use of rt-PA instead of heparin once weekly, as compared with the use of heparin three times a week, as a locking solution for central venous catheters significantly reduced the incidence of catheter malfunction and bacteremia. (Current Controlled Trials number, ISRCTN35253449.).

Long-term effects of early life rainfall shocks on foundational cognitive skills: Evidence from Peru.

Global warming is changing precipitation patterns, particularly harming communities in low-and-middle income countries (LMICs). Whilst the long-term effects of being exposed to rainfall shocks early in life on school-achievement tests are well-established, there is little population-based evidence from LMICs on the mechanisms through which these shocks operate. Executive functions (EFs) are key for children's learning abilities. This paper analyses the effects of early exposure to rainfall shocks on four foundational cognitive skills (FCSs), including EFs that have been found to be key predictors of educational success. These skills were measured via a series of tablet-based tasks administered in Peru as part of the Young Lives longitudinal study (YLS). We combine the YLS data with gridded data on monthly precipitation to generate monthly, community-level rainfall shock estimates. The key identification strategy relies on temporary climatic shocks being uncorrelated with other latent determinants of FCSs development. Our results show significant negative effects of early life exposure to rainfall shocks on EFs-especially, on working memory-measured in later childhood. We also find evidence of rainfall shocks decreasing households' abilities to invest in human capital, which may affect both FCSs and domain-specific test scores. Finally, there is suggestive, but not conclusive, evidence that a conditional-cash-transfer program providing poor households with additional financial resources might partially offset the effects of the rainfall shocks.

The impact of the Starting dialysis on Time, At home on the Right Therapy (START) project on the use of peritoneal dialysis.

BACKGROUND: Peritoneal dialysis (PD) is actively promoted, but increasing PD utilisation is difficult. The objective of this study was to determine if the Starting dialysis on Time, At Home, on the Right Therapy (START) project was associated with an increase in the proportion of dialysis patients receiving PD within 6 months of starting therapy. METHODS: Consecutive patients over age 18, with end-stage kidney failure, who started dialysis between 1 April 2015 and 31 March 2018 in the province of Alberta, Canada. Programmes were provided with high-quality data about the individual steps in the process of care that drive PD utilisation that were used to identify problem areas, design and implement interventions to address them, and then evaluate whether those interventions had impact. The primary outcome was the proportion of patients receiving PD within 6 months of starting dialysis. Secondary outcomes included hospitalisation, death or probability of transfer to haemodialysis (HD). Interrupted time series methodology was used to evaluate the impact of the quality improvement initiative on the primary and secondary outcomes. RESULTS: A total of 1962 patients started dialysis during the study period. Twenty-seven per cent of incident patients received PD at baseline, and there was a 5.4% (95% confidence interval: 1.5-9.2) increase in the use of PD in the province immediately after implementation. There were no changes in the rates of hospitalisation, death or probability of transfer to HD after the introduction of START. CONCLUSIONS: The approach used in the START project was associated with an increase in the use of PD in a setting with high baseline utilisation.

Hemoglobin stability in patients with anemia, CKD, and type 2 diabetes: an analysis of the TREAT (Trial to Reduce Cardiovascular Events With Aranesp Therapy) placebo arm.

BACKGROUND: Sparse data are available about the natural history of hemoglobin (Hb) level trends in contemporary patients with anemia, chronic kidney disease (CKD), and type 2 diabetes mellitus. We intended to describe Hb level trends over time with no or minimal administration of erythropoiesis-stimulating agents. STUDY DESIGN: Prospective clinical trial cohort. SETTING & PARTICIPANTS: 2,019 individuals with type 2 diabetes, moderate anemia, and CKD from the placebo arm of the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT) followed up for 2.3 years with an average of 32 monthly Hb level determinations per patient. Darbepoetin alfa was administered only if Hb level decreased to <9 g/dL. OUTCOMES & MEASUREMENTS: Number of protocol-directed doses of darbepoetin alfa received due to an Hb level decrease to <9 g/dL. RESULTS: 1,106 (55%) placebo patients consistently maintained an Hb level ≥9 g/dL and received no protocol-directed darbepoetin alfa. The other patients received 1 (16%), 2-4 (16%), or 5 or more (13%) doses of darbepoetin alfa. Those who received no darbepoetin alfa doses had higher baseline Hb levels, higher estimated glomerular filtration rates (eGFRs), less proteinuria, and lower ferritin and transferrin saturation values. On average, Hb levels were stable or increased in all groups. Compared with individuals who received no darbepoetin alfa, those who received 5 or more doses were more likely to receive intravenous iron therapy and blood transfusions and progress to renal replacement therapy, but were not at higher risk of death. The strongest predictors of requiring 5 or more doses of darbepoetin alfa were lower baseline Hb level, lower eGFR, and higher proteinuria level. LIMITATIONS: Post hoc analysis of a clinical trial of a specific population with diabetes, anemia, and non-dialysis-dependent CKD. CONCLUSIONS: In the TREAT placebo arm, Hb levels were stable with no or minimal protocol-directed darbepoetin alfa during 2.3 years of follow-up. Most patients with moderate anemia, non-dialysis-dependent CKD, and type 2 diabetes are able to maintain a stable Hb level without implementing long-term erythropoiesis-stimulating agent therapy.

Assessment of the Siksika chronic disease nephropathy-prevention clinic.

OBJECTIVE: To determine if a community-based multifactorial intervention clinic led by a nurse practitioner would improve management of First Nations people at risk of developing chronic kidney disease. DESIGN: Qualitative descriptive study. SETTING: A nephropathy-prevention clinic in Siksika Nation, Alta. PARTICIPANTS: First Nations people with diabetes, hypertension, or dyslipidemia who were referred to the clinic. MAIN OUTCOME MEASURES: Changes in blood pressure (BP), hemoglobin A(1c), and low-density lipoprotein levels, as well as in use of antiplatelet therapy, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker medications, and statin therapy. RESULTS: Members of the Siksika Nation were treated according to clinical practice guidelines. A total of 78 patients had at least 2 visits to the clinic and were included in this analysis (61.5% were women; mean age 56 years). Among those initially above target, a significant reduction was achieved in mean hemoglobin A(1c) (0.96%; P < .01), systolic BP (15.84 mm Hg; P < .05), diastolic BP (7.16 mm Hg; P < .001), and low-density lipoprotein (0.62 mmol/L; P < .01) levels. There was a significant increase in the proportion of patients with clinical indications who were treated with acetylsalicylic acid (42.4%; P < .01), angiotensin-converting enzyme inhibitor or angiotensin receptor blocker medications (35.9%; P < .01), or statin therapy (35.9%; P < .01). CONCLUSION: A community-based, nurse practitioner-led clinic can improve many clinically relevant factors in patients at risk of developing chronic kidney disease. Studies have shown that achieving treatment targets is associated with a reduced risk of early death and cardiovascular events; the effect in the First Nations population on these hard clinical end points remains to be determined.

Use of sodium-glucose cotransporter 2 inhibitors in Alberta adults with chronic kidney disease: a cross-sectional study identifying care gaps to inform knowledge translation.

BACKGROUND: Sodium-glucose cotransporter 2 (SGLT2) inhibitors have important kidney and cardiovascular benefits in adults with chronic kidney disease. Among adults with diabetes, we characterized the prevalence of chronic kidney disease eligible for SGLT2 inhibitor treatment, based on definitions of eligibility from trials and diabetes guidelines, and assessed the predictors of SGLT2 inhibitor use. METHODS: We conducted a cross-sectional study using linked administrative data from Alberta Health in adults with diabetes (2002-2019). Chronic kidney disease was defined as an estimated glomerular filtration rate (eGFR) less than 90 mL/min/1.73 m2 with severe or greater proteinuria (trial-based definition); or eGFR less than 60 mL/min/1.73 m2 or moderate or greater proteinuria regardless of eGFR (diabetes guideline-based definition). Predictors (sociodemographic characteristics, comorbidities and health care utilization) of SGLT2 inhibitor use were identified using logistic regression. RESULTS: Of 446 315 adults with diabetes, 76 630 (17.2%, guideline-based definition; 12 867 [2.9%], trial-based definition) had chronic kidney disease eligible for SGLT2 inhibitor treatment. A total of 7.1% used SGLT2 inhibitors. Older age, lower hemoglobin A1c (HbA1c) levels, female sex, lower neighbourhood income, rural residence and hospital admission were among variables associated with nonuse of SGLT2 inhibitors (adjusted odds ratios [ORs] from 0.13 [age ≥ 85 yr] to 0.92 [rural residence], p < 0.05). Family physician visits were associated with higher SGLT2 inhibitor use (adjusted OR 4.01, p < 0.001 for > 4 visits/yr). Considering all adults, both with and without diabetes, 162 012 individuals with chronic kidney disease (5% of all Alberta adults) may benefit from treatment with SGLT2 inhibitors. INTERPRETATION: Many adults with chronic kidney disease would derive heart and kidney benefits from treatment with SGLT2 inhibitors but had low SGLT2 inhibitor use as of 2019. Efforts will be needed to address lower use of SGLT2 inhibitors among female, older and lower-income adults, and to enhance primary care and promote awareness of the benefits of SGLT2 inhibitors independent of glycemic control.

First randomised controlled trial comparing the sirolimus-eluting bioadaptor with the zotarolimus-eluting drug-eluting stent in patients with de novo coronary artery lesions: 12-month clinical and imaging data from the multi-centre, international, BIODAPTOR-RCT.

Background: The DynamX™ bioadaptor is the first coronary implant technology with a unique mechanism of unlocking the bioadaptor frame after polymer resorption over 6 months, uncaging the vessel while maintaining a dynamic support to the vessel. It aims to achieve the acute performance of drug-eluting stents (DES) with the advantages of restoration of vessel function. Methods: This international, single blinded, randomised controlled (1:1) trial compared a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent (DES) in 34 hospitals in Europe, Japan and New Zealand. Patients with de novo coronary lesions and absence of acute myocardial infarction were enrolled from January 2021 to Feburary 2022. The implantation of the bioadaptor followed the standards of DES. An imaging subset of 100 patients had angiographic and intravascular ultrasound assessments, and 20 patients additionally optical coherence tomography. Data collection will continue through 5 years, we herein report 12-month data based on an intention-to-treat population. This trial is registered at ClinicalTrials.gov (NCT04192747). Findings: 445 patients were randomised between January 2021 and February 2022. Device, lesion and procedural success rates, and acute gain were similar amongst the groups. The primary endpoint, 12-month target lesion failure, was 1.8% [95% CI: 0.5; 4.6] (n = 4) versus 2.8% [95% CI: 1.0; 6.0] (n = 6), pnon-inferiority < 0.001 for the bioadaptor and the DES, respectively (Δ-1.0% [95% CI: -3.3; 1.4]). One definite or probable device thrombosis occurred in each group. The 12-month imaging endpoints showed superior effectiveness of the bioadaptor such as in-device late lumen loss (0.09 mm [SD 0.34] versus 0.25 mm [SD 0.39], p = 0.04), and restored compliance and cyclic pulsatility (%mid in-device lumen area change of 7.5% versus 2.7%, p < 0.001). Interpretation: This is the first randomised controlled trial comparing the novel bioadaptor technology against a contemporary DES. The bioadaptor demonstrated similar acute performance and 12-month clinical outcomes, and superior imaging endpoints including restoration of vessel function. Funding: The study was funded by Elixir Medical.

What do gas-rich galaxies actually tell us about modified Newtonian dynamics?

It has recently been claimed that measurements of the baryonic Tully-Fisher relation (BTFR), a power-law relationship between the observed baryonic masses and outer rotation velocities of galaxies, support the predictions of modified Newtonian dynamics for the slope and scatter in the relation, while challenging the cold dark matter (CDM) paradigm. We investigate these claims, and find that (1) the scatter in the data used to determine the BTFR is in conflict with observational uncertainties on the data, (2) these data do not make strong distinctions regarding the best-fit BTFR parameters, (3) the literature contains a wide variety of measurements of the BTFR, many of which are discrepant with the recent results, and (4) the claimed CDM "prediction" for the BTFR is a gross oversimplification of the complex galaxy-scale physics involved. We conclude that the BTFR is currently untrustworthy as a test of CDM.

The evolution of young people's mental health during COVID-19 and the role of food insecurity: Evidence from a four low-and-middle-income-country cohort study.

OBJECTIVES: Provide evidence on how young people's mental health has evolved in Low-and-Middle-Income-Countries (LMICs) during the progression of the COVID-19 pandemic. Identify particularly vulnerable groups who report high and/or continuously high rates of mental health issues. STUDY DESIGN: Longitudinal, observational. METHODS: Two consecutive phone-surveys (August-October and November-December 2020) in Ethiopia, India, Peru and Vietnam interviewed around 9000 participants of a 20-year cohort study who grew up in poverty, now aged 19 and 26. Rates of at least mild anxiety/depression measured by GAD-7/PHQ-8 were each compared across countries; between males/females, and food secure/food insecure households. RESULTS: Overall, rates of at least mild anxiety and mild depression significantly decreased between mid and end-2020 in all countries but Ethiopia as COVID-19 infection rates fell. Females report higher rates of anxiety and depression in all countries but Ethiopia, however the gender gap is closing. Young people in food insecure households have not shown consistent improvements in their rates of anxiety and depression. Food insecure households are poorer, and have significantly more children (p < 0.05) except in Ethiopia. CONCLUSION: Food insecurity is negatively associated with young people's mental health and urgent support targeted towards the most vulnerable should be a priority. Further research into increasing rates of mental health issues in Ethiopia is needed.