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With the intent of improving transparency in clinical research, the International Committee of Medical Journal Editors (ICMJE) established guidelines in 2005 regarding prospective clinical trial registration. This action worked to address bias related to selective outcome reporting in the medical literature. The objective of this study was to assess and characterize the quality of registration of clinical trials appearing in shoulder arthroplasty-related medical journals. All randomized trials involving human subjects, pertaining to shoulder arthroplasty, published between July 1, 2005 and December 31, 2015, and indexed in either PubMed or SportDISCUS were analyzed. We assessed the prevalence of registration, the timing of registration relative to patient enrollment periods, and the variable rates of orthopedic journal compliance with ICMJE and Food and Drug Administration clinical registration standards for our study. Of the 382 articles identified, 345 (90.3%) were excluded due to failure to meet inclusion criteria. From the remaining 37, only 12 (32.4%) studies were found to be registered in a trial registry. Ten (10/12, 83.3%) of these provided their registration information within the body of the article. None of the included studies from ICMJE-recognized journals were registered. From 34 included studies from non-ICMJE recognized journals, 12 (35.3%) were registered. The level of compliance with clinical trial registration guidelines in the decade since their release among shoulder arthroplasty trials in orthopedic journals is poor. Given the importance of the issue, the prevalence of the problem, and the fact that many other medical specialties have already made efforts to improve ICMJE compliance, further work on the part of orthopedic surgery journal authors and editors is needed to ensure the publication of unbiased results. UMIN000022487.

Aims/hypothesis The euglycaemic–hyperinsulinaemic clamp (EIC) is the reference standard for the measurement of whole-body insulin sensitivity but is laborious and expensive to perform. We aimed to assess the incremental value of high-throughput plasma proteomic profiling in developing signatures correlating with the M value derived from the EIC. Methods We measured 828 proteins in the fasting plasma of 966 participants from the Relationship between Insulin Sensitivity and Cardiovascular disease (RISC) study and 745 participants from the Uppsala Longitudinal Study of Adult Men (ULSAM) using a high-throughput proximity extension assay. We used the least absolute shrinkage and selection operator (LASSO) approach using clinical variables and protein measures as features. Models were tested within and across cohorts. Our primary model performance metric was the proportion of the M value variance explained ( R 2 ). Results A standard LASSO model incorporating 53 proteins in addition to routinely available clinical variables increased the M value R 2 from 0.237 (95% CI 0.178, 0.303) to 0.456 (0.372, 0.536) in RISC. A similar pattern was observed in ULSAM, in which the M value R 2 increased from 0.443 (0.360, 0.530) to 0.632 (0.569, 0.698) with the addition of 61 proteins. Models trained in one cohort and tested in the other also demonstrated significant improvements in R 2 despite differences in baseline cohort characteristics and clamp methodology (RISC to ULSAM: 0.491 [0.433, 0.539] for 51 proteins; ULSAM to RISC: 0.369 [0.331, 0.416] for 67 proteins). A randomised LASSO and stability selection algorithm selected only two proteins per cohort (three unique proteins), which improved R 2 but to a lesser degree than in standard LASSO models: 0.352 (0.266, 0.439) in RISC and 0.495 (0.404, 0.585) in ULSAM. Reductions in improvements of R 2 with randomised LASSO and stability selection were less marked in cross-cohort analyses (RISC to ULSAM R 2 0.444 [0.391, 0.497]; ULSAM to RISC R 2 0.348 [0.300, 0.396]). Models of proteins alone were as effective as models that included both clinical variables and proteins using either standard or randomised LASSO. The single most consistently selected protein across all analyses and models was IGF-binding protein 2. Conclusions/interpretation A plasma proteomic signature identified using a standard LASSO approach improves the cross-sectional estimation of the M value over routine clinical variables. However, a small subset of these proteins identified using a stability selection algorithm affords much of this improvement, especially when considering cross-cohort analyses. Our approach provides opportunities to improve the identification of insulin-resistant individuals at risk of insulin resistance-related adverse health consequences. Graphical Abstract

BackgroundThe COVID-19 pandemic necessitated major reallocation of healthcare services. Our aim was to assess the impact on paediatric congenital heart disease (CHD) procedures during different pandemic periods compared with the prepandemic period, to inform appropriate responses to future major health services disruptions.Methods and resultsWe analysed 26 270 procedures from 17 860 children between 1 January 2018 and 31 March 2022 in England, linking them to primary/secondary care data. The study period included prepandemic and pandemic phases, with the latter including three restriction periods and corresponding relaxation periods. We compared procedure characteristics and outcomes between each pandemic period and the prepandemic period. There was a reduction in all procedures across all pandemic periods, with the largest reductions during the first, most severe restriction period (23 March 2020 to 23 June 2020), and the relaxation period following second restrictions (3 December 2020 to 4 January 2021) coinciding with winter pressures. During the first restrictions, median procedures per week dropped by 51 compared with the prepandemic period (80 vs 131 per week, p=4.98×10−08). Elective procedures drove these reductions, falling from 96 to 44 per week (p=1.89×10−06), while urgent (28 vs 27 per week, p=0.649) and life-saving/emergency procedures (7 vs 6 per week, p=0.198) remained unchanged. Cardiac surgery rates increased, and catheter-based procedure rates reduced during the pandemic. Procedures for children under 1 year were prioritised, especially during the first four pandemic periods. No evidence was found for differences in postprocedure complications (age-adjusted OR 1.1 (95% CI 0.9, 1.4)) or postprocedure mortality (age and case mix adjusted OR 0.9 (95% CI 0.6, 1.3)).ConclusionsPrioritisation of urgent, emergency and life-saving procedures during the pandemic, particularly in infants, did not impact paediatric CHD postprocedure complications or mortality. This information is valuable for future major health services disruptions, though longer-term follow-up of the effects of delaying elective surgery is needed.

We report the discovery and orbital characterization of three new transiting warm giant planets. These systems were initially identified as presenting single transit events in the light curves generated from the full frame images of the Transiting Exoplanet Survey Satellite (TESS). Follow-up radial velocity measurements and additional light curves were used to determine the orbital periods and confirm the planetary nature of the candidates. The planets orbit slightly metal-rich late F- and early G-type stars. We find that TOI 4406b has a mass of \\(M_P\\)= 0.30 \\(\\pm\\) 0.04 \\(M_J\\) , a radius of \\(R_P\\)= 1.00 \\(\\pm\\) 0.02 \\(R_J\\) , and a low eccentricity orbit (e=0.15 \\(\\pm\\) 0.05) with a period of P= 30.08364 \\(\\pm\\) 0.00005 d . TOI 2338b has a mass of \\(M_P\\)= 5.98 \\(\\pm\\) 0.20 \\(M_J\\) , a radius of \\(R_P\\)= 1.00 \\(\\pm\\) 0.01 \\(R_J\\) , and a highly eccentric orbit (e= 0.676 \\(\\pm\\) 0.002 ) with a period of P= 22.65398 \\(\\pm\\) 0.00002 d . Finally, TOI 2589b has a mass of \\(M_P\\)= 3.50 \\(\\pm\\) 0.10 \\(M_J\\) , a radius of \\(R_P\\)= 1.08 \\(\\pm\\) 0.03 \\(R_J\\) , and an eccentric orbit (e = 0.522 \\(\\pm\\) 0.006 ) with a period of P= 61.6277 \\(\\pm\\) 0.0002 d . TOI 4406b and TOI 2338b are enriched in metals compared to their host stars, while the structure of TOI 2589b is consistent with having similar metal enrichment to its host star.

We report the discovery of TOI 694 b and TIC 220568520 b, two low-mass stellar companions in eccentric orbits around metal-rich Sun-like stars, first detected by the Transiting Exoplanet Survey Satellite (TESS). TOI 694 b has an orbital period of 48.05131\\(\\pm\\)0.00019 days and eccentricity of 0.51946\\(\\pm\\)0.00081, and we derive a mass of 89.0\\(\\pm\\)5.3 \\(M_J\\) (0.0849\\(\\pm\\)0.0051 \\(M_\\odot\\)) and radius of 1.111\\(\\pm\\)0.017 \\(R_J\\) (0.1142\\(\\pm\\)0.0017 \\(R_\\odot\\)). TIC 220568520 b has an orbital period of 18.55769\\(\\pm\\)0.00039 days and eccentricity of 0.0964\\(\\pm\\)0.0032, and we derive a mass of 107.2\\(\\pm\\)5.2 \\(M_J\\) (0.1023\\(\\pm\\)0.0050 \\(M_\\odot\\)) and radius of 1.248\\(\\pm\\)0.018 \\(R_J\\) (0.1282\\(\\pm\\)0.0019 \\(R_\\odot\\)). Both binary companions lie close to and above the Hydrogen burning mass threshold that separates brown dwarfs and the lowest mass stars, with TOI 694 b being 2-\\(\\sigma\\) above the canonical mass threshold of 0.075 \\(M_\\odot\\). The relatively long periods of the systems mean that the magnetic fields of the low-mass companions are not expected to inhibit convection and inflate the radius, which according to one leading theory is common in similar objects residing in short-period tidally-synchronized binary systems. Indeed we do not find radius inflation for these two objects when compared to theoretical isochrones. These two new objects add to the short but growing list of low-mass stars with well-measured masses and radii, and highlight the potential of the TESS mission for detecting such rare objects orbiting bright stars.

We report the discovery of NGTS-11 b (=TOI-1847 b), a transiting Saturn in a 35.46-day orbit around a mid K-type star (Teff=5050 K). We initially identified the system from a single-transit event in a TESS full-frame image light-curve. Following seventy-nine nights of photometric monitoring with an NGTS telescope, we observed a second full transit of NGTS-11 b approximately one year after the TESS single-transit event. The NGTS transit confirmed the parameters of the transit signal and restricted the orbital period to a set of 13 discrete periods. We combined our transit detections with precise radial velocity measurements to determine the true orbital period and measure the mass of the planet. We find NGTS-11 b has a radius of 0.817+0.028-0.032 \\(R_J\\), a mass of 0.344+0.092-0.073 \\(M_J\\), and an equilibrium temperature of just 435+34-32 K, making it one of the coolest known transiting gas giants. NGTS-11 b is the first exoplanet to be discovered after being initially identified as a TESS single-transit event, and its discovery highlights the power of intense photometric monitoring in recovering longer-period transiting exoplanets from single-transit events.

Discovering transiting exoplanets with relatively long orbital periods (\\(>\\)10 days) is crucial to facilitate the study of cool exoplanet atmospheres (\\(T_{\\rm eq} < 700 K\\)) and to understand exoplanet formation and inward migration further out than typical transiting exoplanets. In order to discover these longer period transiting exoplanets, long-term photometric and radial velocity campaigns are required. We report the discovery of TOI-2447 b (\\(=\\) NGTS-29b), a Saturn-mass transiting exoplanet orbiting a bright (T=10.0) Solar-type star (T\\(_{\\rm eff}\\)=5730 K). TOI-2447 b was identified as a transiting exoplanet candidate from a single transit event of 1.3% depth and 7.29 h duration in \\(TESS\\) Sector 31 and a prior transit event from 2017 in NGTS data. Four further transit events were observed with NGTS photometry which revealed an orbital period of P=69.34 days. The transit events establish a radius for TOI-2447 b of \\(0.865 \\pm 0.010\\rm R_{\\rm J}\\), while radial velocity measurements give a mass of \\(0.386 \\pm 0.025 \\rm M_{\\rm J}\\). The equilibrium temperature of the planet is \\(414\\) K, making it much cooler than the majority of \\(TESS\\) planet discoveries. We also detect a transit signal in NGTS data not caused by TOI-2447 b, along with transit timing variations and evidence for a \\(\\sim\\)150 day signal in radial velocity measurements. It is likely that the system hosts additional planets, but further photometry and radial velocity campaigns will be needed to determine their parameters with confidence. TOI-2447 b/NGTS-29b joins a small but growing population of cool giants that will provide crucial insights into giant planet composition and formation mechanisms.