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Smoking is a leading cause of numerous human disorders including pulmonary disease, cardiovascular disease, and cancer. Disease development is primarily caused by exposure to cigarette smoke constituents, many of which are known toxicants. Switching smokers to modified risk tobacco products (MRTPs) has been suggested as a potential means to reduce the risks of tobacco use, by reducing such exposure. This randomized, controlled study investigated whether biomarkers of toxicant exposure (BoE) were reduced when smokers switched from smoking combustible cigarettes to using a novel (glo™/THP1.0) or in-market comparator (iQOS/THS) tobacco heating product (THP). One hundred eighty Japanese smokers smoked combustible cigarettes during a 2-day baseline period, followed by randomization to either continue smoking cigarettes, switch to using mentholated or non-mentholated variants of glo™, switch to using a non-mentholated variant of iQOS, or quit nicotine and tobacco product use completely for 5 days. Baseline and post-randomization 24-h urine samples were collected for BoE analysis. Carbon monoxide was measured daily in exhaled breath (eCO). On day 5 after switching, urinary BoE (excluding for nicotine) and eCO levels were significantly (p < .05) reduced by medians between 20.9% and 92.1% compared with baseline in all groups either using glo™ or iQOS or quitting tobacco use. Between-group comparisons revealed that the reductions in the glo™ groups were similar (p > .05) to quitting in many cases. glo™ or iQOS use for 5 days reduced exposure to smoke toxicants in a manner comparable to quitting tobacco use. THPs are reduced exposure tobacco products with the potential to be MRTPs. This clinical study demonstrates that when smokers switched from smoking combustible cigarettes to using tobacco heating products their exposure to smoke toxicants was significantly decreased. In many cases, this was to the same extent as that seen when they quit smoking completely. This may indicate that these products have the potential to be reduced exposure and/or reduced risk tobacco products when used by smokers whose cigarette consumption is displaced completely. ISRCTN14301360 and UMIN000024988.

Background Smoking is a leading cause of numerous human disorders including lung cancer, chronic obstructive pulmonary disease, and atherosclerotic cardiovascular disease. The development of modified risk tobacco products (MRTPs) has been suggested as a possible way to reduce the risks of tobacco smoking by reducing exposure to cigarette smoke toxicants. This study is designed to investigate whether biomarkers of such exposure are reduced when smokers switch from smoking commercial cigarettes to using either a novel or a commercially-available tobacco heating product (THP). Design and Methods This study will assess biomarkers of exposure in current smokers who either remain smoking, switch to THP use, or quit all tobacco use completely, for 5 days. The study is an in-clinic (confinement) two-centre, randomised controlled clinical study with a forced-switching design. Subjects of either gender will be aged 23–55 years (minimum legal smoking age plus 3 years), of Japanese origin and with a verified smoking status (assessed by exhaled breath carbon monoxide and urinary cotinine levels). Subjects will have a usual brand cigarette within the International Organisation for Standardisation (ISO) tar band of 6-8 mg and will be judged to be healthy by medical history, physical examination, vital signs, electrocardiography (ECG), clinical biochemistry and lung function tests. The primary objective of this study is to assess changes within groups in selected biomarkers of exposure (BoE) and of biological effect (BoBE) after a forced switch from a commercial control cigarette to either a menthol or a non-menthol THP. Secondary objectives are to assess between-group differences, to determine nicotine pharmacokinetics for cigarettes and THPs, to assess subject’s satisfaction with the study products, and to monitor additional endpoints related to safety and product use. Discussion Data from this study will advance our scientific understanding of the changes in exposure to cigarette smoke toxicants in smokers who switch to using a THP. Trial registrations UMIN000024988 (25th November 2016); ISRCTN14301360 (14th December 2016)

ObjectivesTo identify: (1) patient-reported outcome measures (PROMs) used to evaluate symptoms, health status or quality of life following discretionary revision (or re-revision) knee joint replacement, and (2) validated joint-specific PROMs, their measurement properties and quality of evidence.Design(1) Scoping review; (2) systematic review following the COnsensus-based Standards for selection of health status Measurement INstruments (COSMIN) checklist.Data sourcesMEDLINE, Embase, AMED and PsycINFO were searched from inception to 1 July 2020 using the Oxford PROM filter unlimited by publication date or language.Eligibility criteria for selecting studiesStudies reporting on the development, validation or outcome of a joint-specific PROM for revision knee joint replacement were included.Results51 studies reported PROM outcomes using eight joint-specific PROMs. 27 out of 51 studies (52.9%) were published within the last 5 years. PROM development was rated ‘inadequate’ for each of the eight PROMs studied. Validation studies were available for only three joint-specific PROMs: Knee Injury and Osteoarthritis Outcome Score (KOOS), Lower Extremity Activity Scale (LEAS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC). 25 out of 27 (92.6%) measurement properties were rated insufficient, indeterminate or not assessed. The quality of supporting evidence was mostly low or very low. Each of the validated PROMs was rated ‘B’ (potential for recommendation but require further evaluation).ConclusionJoint-specific PROMs are increasingly used to report outcomes following revision knee joint replacement, but these instruments have insufficient evidence for their validity. Future research should be directed toward understanding the measurement properties of these instruments in order to inform clinical trials and observational studies evaluating the outcomes from joint-specific PROMs.

Background The aim of this systematic review was to summarise the evidence for the clinical effectiveness of revision knee arthroplasty (rKA) compared to non-operative treatment for the management of patients with elective, aseptic causes for a failed knee arthroplasty. Methods MEDLINE, Embase, AMED and PsychINFO were searched from inception to 1st December 2020 for studies on patients considering elective, aseptic rKA. Patient-relevant outcomes (PROs) were defined as implant survivorship, joint function, quality of life (QoL), complications and hospital admission impact. Results No studies compared elective, aseptic rKA to non-operative management. Forty uncontrolled studies reported on PROs following elective, aseptic rKA (434434 rKA). Pooled estimates for implant survivorship were: 95.5% (95% CI 93.2–97.7%) at 1 year [seven studies (5524 rKA)], 90.8% (95% CI 87.6–94.0%) at 5 years [13 studies (5754 rKA)], 87.4% (95% CI 81.7–93.1%) at 10 years [nine studies (2188 rKA)], and 83.2% (95% CI 76.7–89.7%) at 15 years [two studies (452 rKA)]. Twelve studies (2382 rKA) reported joint function and/or QoL: all found large improvements from baseline to follow-up. Mortality rates were low (0.16% to 2% within 1 year) [four studies (353064 rKA)]. Post-operative complications were common (9.1 to 37.2% at 90 days). Conclusion Higher-quality evidence is needed to support patients with decision-making in elective, aseptic rKA. This should include studies comparing operative and non-operative management. Implant survivorship following elective, aseptic rKA was ~ 96% at 1 year, ~ 91% at 5 years and ~ 87% at 10 years. Early complications were common after elective, aseptic rKA and the rates summarised here can be shared with patients during informed consent. Systematic review registration PROSPERO CRD42020196922

Background. An urgent UK investigation was launched to assess risk of invasive Mycobacterium chimaera infection in cardiothoracic surgery and a possible association with cardiopulmonary bypass heater-cooler units following alerts in Switzerland and The Netherlands. Methods. Parallel investigations were pursued: (1) identification of cardiopulmonary bypass–associated M. chimaera infection through national laboratory and hospital admissions data linkage; (2) cohort study to assess patient risk; (3) microbiological and aerobiological investigations of heater-coolers in situ and under controlled laboratory conditions; and (4) whole-genome sequencing of clinical and environmental isolates. Results. Eighteen probable cases of cardiopulmonary bypass–associated M. chimaera infection were identified; all except one occurred in adults. Patients had undergone valve replacement in 11 hospitals between 2007 and 2015, a median of 19 months prior to onset (range, 3 months to 5 years). Risk to patients increased after 2010 from <0.2 to 1.65 per 10000 person-years in 2013, a 9-fold rise for infections within 2 years of surgery (rate ratio, 9.08 [95% CI, 1.81–87.76]). Endocarditis was the most common presentation (n = 11). To date, 9 patients have died. Investigations identified aerosol release through breaches in heater-cooler tanks. Mycobacterium chimaera and other pathogens were recovered from water and air samples. Phylogenetic analysis found close clustering of strains from probable cases. Conclusions. We identified low but escalating risk of severe M. chimaera infection associated with heater-coolers with cases in a quarter of cardiothoracic centers. Our investigations strengthen etiological evidence for the role of heater-coolers in transmission and raise the possibility of an ongoing, international point-source outbreak. Active management of heater-coolers and heightened clinical awareness are imperative given the consequences of infection.

The explosion of artificial intelligence, the possible end of Moore's law, dawn of quantum computing, and the continued exponential growth of data communications traffic have brought new urgency to the need for laser integration on the diversified Si platform. While diode lasers on group III‐V platforms have long‐powered internet data communications and other optoelectronic technologies, direct integration with Si remains problematic. A paradigm‐shifting solution requires exploring new and unconventional materials and integration approaches. In this work, it is shown that a sub‐10‐nm ultra‐thin Si1−xGex buffer layer fabricated by an oxidative solid‐phase epitaxy process can facilitate extraordinarily efficient strain relaxation. The Si1−xGex layer is formed by ion implanting Ge into Si(111) and selectively oxidizing Si atoms in the resulting ion‐damaged layer, precipitating a fully strain‐relaxed Ge‐rich layer between the Si substrate and surface oxide. The efficient strain relaxation results from the high oxidation temperature, producing a periodic network of dislocations at the substrate interface, coinciding with modulations of the Ge content in the Si1−xGex layer and indicating the presence of defect‐mediated diffusion of Si through the layer. The epitaxial growth of high‐quality GaAs is demonstrated on this ultra‐thin Si1−xGex layer, demonstrating a promising new pathway for integrating III‐V lasers directly on the Si platform. Sub‐10‐nm‐thick strain‐relaxed Si1−xGex buffer layers are fabricated on Si by oxidative solid‐phase epitaxy and employed as a new platform for group III‐V heteroepitaxy on the Si platform. Si1−xGex/Si interface strain relaxation occurs via a periodic dislocation network coinciding with composition fluctuations, resulting from defect‐mediated diffusion of Si and Ge during oxidation.

This paper introduces the Welsh Advanced Neuroimaging Database (WAND), a multi-scale, multi-modal imaging dataset comprising in vivo brain data from 170 healthy volunteers (aged 18–63 years), including 3 Tesla (3 T) magnetic resonance imaging (MRI) with ultra-strong (300 mT/m) magnetic field gradients, structural and functional MRI and nuclear magnetic resonance spectroscopy at 3 T and 7 T, magnetoencephalography (MEG), and transcranial magnetic stimulation (TMS), together with trait questionnaire and cognitive data. Data are organised using the Brain Imaging Data Structure (BIDS). In addition to raw data, we provide brain-extracted T1-weighted images, and quality reports for diffusion, T1- and T2-weighted structural data, and blood-oxygen level dependent functional tasks. Reasons for participant exclusion are also included. Data are available for download through our GIN repository, a data access management system designed to reduce storage requirements. Users can interact with and retrieve data as needed, without downloading the complete dataset. Given the depth of neuroimaging phenotyping, leveraging ultra-high-gradient, high-field MRI, MEG and TMS, this dataset will facilitate multi-scale and multi-modal investigations of the healthy human brain.

Purpose A total laryngectomy creates an alternate airway for gas exchange that bypasses the upper aerodigestive tract. The subsequent reduction in nasal airflow, and therefore, reduction in deposition of particles to the olfactory neuroepithelium leads to hyposmia or anosmia. The aim of this study was to assess the quality of life impairment conferred by anosmia following laryngectomy and identify any specific patient-related risk factors that are associated with poorer outcomes. Methods Consecutive patients with a total laryngectomy presenting for review at three tertiary head and neck services (in Australia, the United Kingdom and India) over a 12-month period were recruited. Patient demographic and clinical data were collected, and each subject completed the validated assessment of self-reported olfactory functioning and olfaction-related quality of life questionnaire (ASOF). Dichotomous comparisons were performed using the student's unpaired t-test for continuous variables (SRP), a chi-squared test for categorical variables, and a Kendall's tau-b for ordinal variables (SOC) to assess for a correlation with poorer questionnaire scores. Results A total of 66 laryngectomees (13.4% female; age 65.7 ± 8.6 years) were included in the study. The mean SRP score of the cohort was found to be 15.6 ± 7.4, while the mean ORQ score was noted to be 16.4 ± 8.1. No other specific risk factors associated with poorer quality of life were identified. Conclusion A significant quality of life detriment from hyposmia is conferred following laryngectomy. Further research to assess treatment options and the patient population that would best benefit from these interventions is required.