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Objective: To develop a sustainable three-step method for titrating first and second taxane exposures through integration of best practices in patient and environmental safety; and to evaluate the impact on immediate hypersensitivity rates., Methods: A quality improvement study was initiated at a large, NCI-designated comprehensive cancer center in the U.S. to determine a sustainable method of slow, upward titration for reducing taxane-related hypersensitivity reactions. Multidisciplinary collaboration led to the incorporation of best practices for safe preparation and administration of high risk, hazardous drugs. Retrospective data from the electronic health records of 690 patients who received 1221 taxane doses were analyzed. Non-titrated infusions were compared with infusions titrated using a method initially tested for efficacy; and infusions titrated using a method revised for greater compliance with safety standards. Two-sided Fisher's exact tests at a 0.1 level of significance were used to detect differences in the rate of HSR between the three groups., Results: A method of taxane titration that incorporated standardized, preprogrammed infusion rates and tubing primed with inert IV fluid showed a significant reduction in HSR incidence in comparison to non-titrated infusions (6% v. 19%, P = 0.001) and a similar decrease in the rate of HSR (6%) to the initial method previously studied (7%) (P = 0.659) which was not sustainable due to patient and environmental safety concerns ., Conclusions: A three-step titration method using standardized, preprogrammed infusion rates and tubing primed with inert IV fluid reduced taxane-related HSRs and was adopted as sustainable practice in ambulatory cancer care., Competing Interests: Declaration of conflicting interestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objective: Pedestrian injury is a leading contributor to childhood deaths. This study compared the crossing behaviors of children with adults when crossing in virtual single-lane vs. two-lane traffic conditions., Method: Using a fully immersive virtual reality system, children 7-10 years and adults crossed streets with traffic in one lane (near lane) or in two lanes (near and far lane) with 0 offset so cars from opposing directions arrived at the child's crossing line at the same time. On each trial, pedestrians made a decision on when to cross and then completed the crossing, with measures of attention and crossing behaviors automatically recorded by the system as they did so., Results: In comparison to crossing a single lane of traffic, crossing two-lane roads increased injury risk for all pedestrians, though children experienced significantly greater risk than adults. Children predominantly crossed by stopping before entering the far lane, whereas adults showed greater synchronization of self-movement to traffic flow and more often crossed both lanes without stopping., Conclusions: Children experience more high-risk outcomes than adults when crossing single-lane roads. Crossing two-lane roads elevates risk for pedestrians of both ages, though this risk is significantly greater for child than adult pedestrians. The predominant strategy used to cross two lanes of traffic shows significant developmental changes. Implications for injury prevention are discussed., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Rationale: New pulmonary rehabilitation models can improve access to this effective but underutilised treatment for people with chronic respiratory disease, however cost effectiveness has not been determined., Objective: To compare the cost effectiveness of telerehabilitation, including videoconferencing and synchronous supervision, to standard center-based pulmonary rehabilitation., Methods: Prospective economic analyses were undertaken from a societal perspective alongside a randomised controlled equivalence trial in which adults with stable chronic respiratory disease undertook an 8-week outpatient center-based program or telerehabilitation. Clinical assessment for effectiveness (Chronic Respiratory Disease Questionnaire dyspnoea domain [CRQ-D] score) was undertaken at baseline, following pulmonary rehabilitation and 12-month follow-up. Individual-level administrative and self-report healthcare cost data were collected over 12 months following the program (Australian dollars, 2020) Results: There were no between-group differences for effectiveness (CRQ-D MD -0.2 [SE 1.0], p=0.61) or total costs ($565 [5452], p=0.92) over 12 months. On the cost effectiveness plane, 97.4% of estimates fell between the equivalence margins for effectiveness. Application of a range of values for cost margin demonstrated a 95% probability that telerehabilitation was equivalent to center-based pulmonary rehabilitation when the threshold was $11,000. Results were robust to approach, sensitivity and subgroup analyses. The internal rate of return was 134% over 5 years. Program completion (regardless of model) was associated with a significant reduction in total costs in the following 12 months (β $-17,960, 95%CI -29,967 to -5952). Conclusions This study supports delivery of telerehabilitation as a cost-effective alternative model of pulmonary rehabilitation for people with chronic respiratory disease.

Objective: To evaluate the association between smell loss and other aspects of disease, and evaluate dupilumab efficacy in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) and moderate or severe smell loss., Methods: This post-hoc analysis of the SINUS-24/52 studies (NCT02912468/NCT02898454) analyzed nasal polyp score (NPS, 0-8), nasal congestion/obstruction (NC, 0-3), Lund-Mackay CT-scan score (LMK-CT, 0-24), rhinosinusitis severity visual analog scale (RS-VAS, 0-10), and 22-item Sinonasal Outcome Test (SNOT-22, 0-110) according to baseline monthly average patient-reported loss of smell scores (LoS, 0-3) of >1 to 2 (moderate) or >2 to 3 (severe) in patients randomized to dupilumab 300 mg or placebo every 2 weeks., Results: Of 724 patients randomized, baseline LoS was severe in 601 (83%) and moderate in 106 (15%). At baseline, severe versus moderate LoS was associated with 1-point greater severity of NC (odds ratio [OR] 6.01 [95% confidence interval, (CI) 3.95, 9.15]), 5-point greater severity of LMK-CT (OR 2.19 [1.69, 2.85]), and 8.9-point greater severity of SNOT-22 (OR 1.35 [1.20, 1.49]). At Week 24, least squares mean differences (95% CI) dupilumab versus placebo in change from baseline were: NPS -1.90 (-2.56, -1.25) and -1.95 (-2.20, -1.70) in the moderate and severe baseline LoS subgroups, respectively; NC -.35 (-.64, -.06) and -1.00 (-1.13, -.87); LMK-CT -6.30 (-7.88, -4.72) and -6.22 (-6.82, -5.63); RS-VAS -1.18 (-2.20, -.16) and -3.47 (-3.90, -3.03); and SNOT-22 -7.52 (-14.55, -.48) and -21.72 (-24.63, -18.82); all nominal P  < .05 versus placebo. Improvements with dupilumab in NC, RS-VAS, and SNOT-22 were statistically greater in patients with severe versus moderate baseline LoS., Conclusion: Significant smell impairment in severe CRSwNP is associated with significant disease (NC, RS-VAS, LMK), health-related quality of life impairment (SNOT-22), asthma, and non-steroidal anti-inflammatory drug-exacerbated respiratory disease. Dupilumab significantly improved NPS, NC, LMK-CT, RS-VAS, and SNOT-22 in subjects with moderate and severe baseline smell loss., Competing Interests: Declaration of Conflicting InterestsThe authors declare the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Zachary M. Soler has been a consultant or advisory board member for Lyra, Novartis, Olympus, and Optinose; he has received speaker's fees from GlaxoSmithKline and Regeneron Pharmaceuticals Inc.; and held the post of medical director at Healthy Humming. Zara M. Patel has been a consultant or advisory board member for Dianosic, InfiniteMD, Mediflix, Medtronic, and Optinose and the Chief Medical Officer of Olfera Therapeutics. Joaquim Mullol has participated in a speakers’ bureau or advisory board or received a research grant from AstraZeneca, Genentech, Inc., GlaxoSmithKline, Glenmark, Menarini, Mitsubishi-Tanabe, Merck Sharp & Dohme, Viatris (Mylan-MEDA), Novartis, Procter & Gamble, Regeneron Pharmaceuticals Inc., Sanofi, and the NOUCOR/Uriach Group. Jose Mattos has no financial disclosures or conflicts of interest. Scott Nash, Changming Xia, Zhixiao Wang, Harry Sacks, and Yamo Deniz are employees of Regeneron Pharmaceuticals and may hold stock and/or stock options in the company. Kinga Borsos is a former employee of Sanofi and may hold stock and/or stock options in the company. Mark Corbett, Juby A. Jacob-Nara, and Paul Rowe are employees of Sanofi and may hold stock and/or stock options in the company. Andrew P. Lane is a member of the advisory boards of Sanofi and Regeneron Pharmaceuticals Inc.

Reduced sense of smell is a common symptom in patients with chronic rhinosinusitis (CRS). Although it is often under-diagnosed by healthcare providers, reduced sense of smell can have a substantial negative impact on patient's quality of life as measured by health-related quality of life (HRQoL) assessments and patient-reported outcomes. This narrative review describes current smell loss diagnosis and management guidelines in CRS, and the relationship between smell loss and CRS. Reduced sense of smell can be an indication of CRS disease severity in patients with (CRSwNP) and without nasal polyps (CRSsNP), and recovery of smell can be an indicator of successful CRS treatment. The current first-line therapeutic options for smell loss are intranasal corticosteroids and nasal irrigation, and second-line therapeutic options include systemic steroids and surgery. Shared decision-making between patient, caregiver, and healthcare provider is important when choosing the most appropriate CRS treatment option. Emerging biologic therapies that target type 2 inflammation signaling pathways, such as dupilumab, omalizumab, and mepolizumab, have been shown to improve smell and taste in randomized controlled trials of patients with CRSwNP.A graphical abstract and video abstract are available with this article., (© 2024. The Author(s).)

Objective: To investigate the effectiveness of a multicomponent breastfeeding support intervention on breastfeeding prevalence at 3 months among women with a body mass index (BMI) >25 kg/m 2 ., Design: Multicentre multicomponent randomised controlled trial., Setting: Four maternity centres in Ireland., Population: A total of 225 primiparous women and their nominated support partners. Participants were aged 18 years and over, with BMI ≥25 kg/m 2 , carrying a singleton pregnancy and without contraindication for breastfeeding., Methods: The intervention included an antenatal group breastfeeding education session for participants and their support partners, followed by a planned postnatal breastfeeding assessment and telephone support for up to 6 weeks by a lactation consultant., Main Outcome Measures: Any breastfeeding at 3 months postpartum., Results: Any breastfeeding prevalence was 68.7% (n = 68) in the intervention group and 62.1% (n = 59) in the control group at 3 months postpartum (odds ratio 1.33, 95% confidence interval 0.72-2.46, p = 0.36). Any and exclusive breastfeeding rates did not significantly differ at any other time point. More women in the control group accessed support from private lactation consultants (intervention 23.5% [n = 12], control 45.3% [n = 24], p = 0.02)., Conclusions: The control group had higher than expected breastfeeding rates, and the study found no evidence of effect on the primary outcome. Providing comprehensive education and support for women intending to breastfeed remains of paramount importance., (© 2024 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Background: Adults with cancer experience a significantly higher level of anxiety compared with the general population. Anxiety is reported at diagnosis and throughout the cancer trajectory, and it is particularly heightened at the initiation of infusion treatments. In 2020, the COVID-19 pandemic exacerbated anxiety levels in patients receiving cancer treatments., Objectives: This evidence-based practice project evaluated the feasibility and effectiveness of using medical-grade weighted blankets to reduce anxiety in patients with cancer receiving the first two infusion treatments in the ambulatory setting., Methods: Patients completed a modified version of the Visual Analog Scale for Anxiety to self-report anxiety pre- and postimplementation. Patients and nurses completed feasibility surveys., Findings: Patients reported reduced anxiety after using a weighted blanket and described weighted blankets as comforting and soothing. More than 90% of surveyed patients agreed or strongly agreed that the blanket was comfortable, not too heavy, and easy to put on, and did not interfere with nursing care or their own activities. Nurses valued the ease of use and adherence to infection control standards.

Objective: Injury as pedestrians is a leading contributor to childhood deaths. This study evaluated the effectiveness of Safe Peds, a fully immersive virtual reality training program to teach children when to cross street safely, with the focus on a number of foundational skills and practicing these in traffic situations of varying complexity., Methods: Children 7-10 years old were randomly assigned to a control (N = 31) or intervention (N = 26) group. Eligibility criteria included English speaking and typically developing. Testing took place on campus. All children completed pre- and post-testing measures, with those in the intervention group receiving training in between. Training comprised 1 session with 3 phases for a total of up to 1.5 hr and was tailored to each child's performance over trials. On each trial, children decided when to cross and fully executed this crossing, with measures automatically taken by the system as they did so., Results: Negative binomial regression and analysis of covariance tests were applied, predicting post-test scores while controlling for pre-test scores, age, and sex. The intervention was effective in improving children's street crossing skills, including stopping and checking skills (stop at the curb, look left/right/left, check for traffic before crossing the yellow line), and choosing safe inter-vehicle gaps. Children in the control group did not show significant improvements in any crossing skills., Conclusions: The Safe Peds program effectively teaches children skills to support their deciding when to safely cross in a variety of traffic situations. Implications for pedestrian injury are discussed., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Cardiovascular instability is common during the reperfusion phase of orthotopic liver transplantation (OLT), and some patients experience a postreperfusion syndrome (PRS). However, there are no reports comparing the cardiac dysfunction between patients with PRS and those without. Thus, the aim of this study was to evaluate cardiac dysfunction in patients exhibiting PRS. This observational retrospective study included 34 patients who underwent OLT and were monitored with transesophageal echocardiography (TEE). The right ventricular/left ventricular (RV/LV) end diastolic area, tricuspid annular plane systolic excursion (TAPSE), left ventricular ejection fraction (LVEF) by Simpson method, pulsed Doppler of the mitral valve, and tissue Doppler motion of the mitral annulus were determined. Echocardiographic measurements were registered at the beginning of surgery and at 1 and 30 min after vascular unclamping. Patients with PRS (PRS group) were identified, and their echocardiographic parameters of ventricular function were compared with those in patients without PRS (non-PRS group). To check the evolution of diastolic-systolic dysfunction, general linear model-repeated measures were estimated. No patient presented systolic/diastolic dysfunction on the basal echocardiogram. One minute after vascular unclamping, the incidence of RV dilation was 4.5 times greater in patients with PRS (Cramer´s V > 0.6), and the incidence of RV systolic dysfunction was 62.5% in patients with PRS compared to 15.40% in patients without PRS (Cramer´s V = 0.45). The incidence of LV systolic dysfunction was 25% in patients with PRS compared to 0% in those without (Cramer´s V = 0.45), and left ventricular diastolic dysfunction was 4.8 times greater in patients with PRS (Cramer´s V = 0.45). No patient presented diastolic dysfunction type III. There were significant differences between groups in the evolutionary pattern at 1 and 30 min after unclamping for RV dilation (p = 0.008) and for TAPSE (p = 0.014). Liver graft reperfusion may alter cardiac function. Cardiac dysfunction was more frequent in patients with PRS. These patients exhibited temporary dysfunction of the RV associated with a varying degree of LV diastolic-systolic dysfunction. Trial registration: clinicaltrials.gov (NCT05175534). January 03, 2022; "retrospectively registered"., (© 2023. The Author(s).)

Objective: The Health Service Executive National Clinical Programme for Eating Disorders (NCPED) launched a Model of Care for Eating Disorder Services in Ireland in 2018. Currently, one adult and two child and adolescent eating disorder services are operational out of a total of sixteen recommended. The three objectives of this paper are to describe the early (1) referral pattern, (2) level of service activity and (3) the level of service user satisfaction., Method: Monthly submitted service activity data from each service to the NCPED between March 2018 and October 2020 were retrospectively analysed. One hundred and fifty-nine carers and service users completed an experience of service questionnaire (ESQ). A descriptive analysis of referral pattern, level of service activity and ESQ was performed. A thematic analysis was performed on three qualitative questions on the ESQ., Results: There was substantial referral numbers to eating disorder services by 18 months ( n = 258). The main referral source was community mental health teams. The majority ( n = 222, 86%) of referrals were offered an assessment. The most common age profile was 10-17 years of age ( n = 120, 54.1%), and anorexia nervosa was the most common disorder ( n = 96, 43.2%). ESQ results demonstrate that most service users were satisfied with their service, and the main themes were carer involvement, staff expertise, therapeutic alliance and service access., Conclusions: This preliminary service activity and service user satisfaction data highlight several issues, including trends when setting up a regional eating disorder service, potential pitfalls of pragmatic data collection and the need for adequate information-technology infrastructure.

Elevated levels of receptor tyrosine kinase-like orphan receptor 1 (RORl) expression are observed in multiple hematological and solid tumors, but not in most of the healthy adult tissues, identifying ROR1 as an attractive target for tumor-specific therapy. Herein we will describe the discovery of macrocyclic peptides as binders of the extracellular Cysteine-Rich Domain (CRD) of human ROR1 via mRNA in vitro selection technology using the PDPS platform, followed by exploration of sidechain SAR of parent macrocycle peptides, fluorescently labeled analogs, and a Peptide Drug Conjugate (PDC). The parent macrocyclic peptides represented by Compound 1 and Compound 14 displayed nanomolar cell-based binding to ROR1 and relatively good internalization in 786-O and MDA-MB-231 tumor cell lines. However, these peptides were not observed to induce apoptosis in Mia PaCa-2 cells, a model pancreatic tumor cell line with a relatively low level of cell surface expression of ROR1., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023. Published by Elsevier Ltd.)

Pre-mRNA splicing is a highly coordinated process. While its dysregulation has been linked to neurological deficits, our understanding of the underlying molecular and cellular mechanisms remains limited. We implicated pathogenic variants in U2AF2 and PRPF19, encoding spliceosome subunits in neurodevelopmental disorders (NDDs), by identifying 46 unrelated individuals with 23 de novo U2AF2 missense variants (including 7 recurrent variants in 30 individuals) and 6 individuals with de novo PRPF19 variants. Eight U2AF2 variants dysregulated splicing of a model substrate. Neuritogenesis was reduced in human neurons differentiated from human pluripotent stem cells carrying two U2AF2 hyper-recurrent variants. Neural loss of function (LoF) of the Drosophila orthologs U2af50 and Prp19 led to lethality, abnormal mushroom body (MB) patterning, and social deficits, which were differentially rescued by wild-type and mutant U2AF2 or PRPF19. Transcriptome profiling revealed splicing substrates or effectors (including Rbfox1, a third splicing factor), which rescued MB defects in U2af50-deficient flies. Upon reanalysis of negative clinical exomes followed by data sharing, we further identified 6 patients with NDD who carried RBFOX1 missense variants which, by in vitro testing, showed LoF. Our study implicates 3 splicing factors as NDD-causative genes and establishes a genetic network with hierarchy underlying human brain development and function.

This study describes a protocol to assess a novel workflow called Epi-Genomic Newborn Screening (EpiGNs) on 100,000 infants from the state of Victoria, Australia. The workflow uses a first-tier screening approach called methylation-specific quantitative melt analysis (MS-QMA), followed by second and third tier testing including targeted methylation and copy number variation analyzes with droplet digital PCR, EpiTYPER system and low-coverage whole genome sequencing. EpiGNs utilizes only two 3.2 mm newborn blood spot punches to screen for genetic conditions, including fragile X syndrome, Prader-Willi syndrome, Angelman syndrome, Dup15q syndrome and sex chromosome aneuploidies. The program aims to: identify clinically actionable methylation screening thresholds for the first-tier screen and estimate prevalence for the conditions screened.

Background: Totally endoscopic ear surgery is a novel method of conducting otological surgery. Hierarchical task analysis and the systematic human error reduction and prediction approach ('SHERPA') are valuable tools that can effectively deconstruct the technical and non-technical skills required to successfully complete a surgical procedure., Methods: Twenty-five endoscopic tragal cartilage tympanoplasties were observed, to identify the tasks and subtasks required for completion of totally endoscopic tragal cartilage tympanoplasty. The systematic human error reduction and prediction approach was used to identify the potential risks and methods, to reduce or remediate these risks., Results: A hierarchical task analysis was performed, identifying 8 tasks and 50 subtasks for a safe approach to completing totally endoscopic tragal cartilage tympanoplasty. A risk score for each subtask was calculated to produce a systematic human error reduction and prediction approach and to highlight potential errors., Conclusion: This hierarchical task analysis allowed for quick reference to a correct method of endoscopic tympanoplasty. The systematic human error reduction and prediction approach was employed to reduce the risks associated with undergoing endoscopic tympanoplasty, to improve patient safety.

Orthopaedic surgeries pose various risks to the health of orthopaedic surgeons: radiation, noise, infection, chemical exposure, and musculoskeletal injury. These are associated with short and long-term health problems including malignancy and teratogenicity. Orthopaedic surgeons' health is critical to ensure optimal patient care. Most of these hazards can be obviated or minimized by adopting rigorous prevention protocols and raising awareness. Further related research is warranted and guidelines regarding prevention need to be framed by regulatory bodies.

Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Background: The COVID-19 pandemic experience was different in each country (e.g., prevalence, societal restrictions). There is limited data on eating disorder (ED) diagnosis and service activity trends within Ireland. The aim of this study is to describe the ED referral and hospitalization trends during COVID-19 in Ireland., Method: Monthly data (2019-2021) from three regional community ED services (two-child and one-adult) were collected. National psychiatric and medical hospitalization data were analyzed. A descriptive and trend analysis was performed., Results: There was a trend of referrals to community ED services during the COVID-19 pandemic for children (p < .0001) and adults (p = .0019). Albeit the increase in child referrals was evident at an earlier point before adult referrals. There was a trend of a diagnosis for children and adults of anorexia nervosa (p < .0001; p = .0257) and other-specified-feeding-or-eating-disorder (OSFED) respectively (p = .0037; p = .0458). There was no trend in psychiatric co-morbidity. There was a trend of child (p = .0003) not adult (n = 0.1669) psychiatric hospitalization. There was a trend of medical hospitalization for child and adult combined (p < .0001)., Conclusion: This study adds to the growing literature on the association of the COVID-19 pandemic on ED trends and the need for future public health and service provision funding to be allocated for mental health services during periods of international crisis., Public Significance: This study illustrates the referral and hospitalization trend in young persons and adults with an ED in Ireland during the COVID-19 pandemic. This study highlights that there was a trend of Anorexia Nervosa and OSFED presentations during the COVID-19 pandemic., (© 2023 The Authors. International Journal of Eating Disorders published by Wiley Periodicals LLC.)

Background: Autonomy-supportive health environments can assist patients in achieving behavior change and can influence adherence positively. Telerehabilitation may increase access to rehabilitation services, but creating an autonomy-supportive environment may be challenging., Research Question: To what degree does telerehabilitation provide an autonomy-supportive environment? What is the patient experience of an 8-week telerehabilitation program?, Study Design and Methods: Individuals undertaking telerehabilitation or center-based pulmonary rehabilitation within a larger randomized controlled equivalence trial completed the Health Care Climate Questionnaire (HCCQ; short form) to assess perceived autonomy support. Telerehabilitation participants were invited 1:1 to undertake semistructured interviews. Interviews were transcribed verbatim and coded thematically to identify major themes and subthemes., Results: One hundred thirty-six participants (n = 69 telerehabilitation) completed the HCCQ and 30 telerehabilitation participants (42%) undertook interviews. HCCQ summary scores indicated that participants strongly agreed that the telerehabilitation environment was autonomy supportive, which was similar to center-based participants (HCCQ summary score, P = .6; individual HCCQ items, P ≥ .3). Telerehabilitation interview data supported quantitative findings identifying five major themes, with subthemes, as follows: (1) making it easier to participate in pulmonary rehabilitation, because telerehabilitation was convenient, saved time and money, and offered flexibility; (2) receiving support in a variety of ways, including opportunities for peer support and receiving an individualized program guided by expert staff; (3) internal and external motivation to exercise as a consequence of being in a supervised group, seeing results for effort, and being inspired by others; (4) achieving success through provision of equipment and processes to prepare and support operation of equipment and technology; and (5) after the rehabilitation program, continuing to exercise, but dealing with feelings of loss., Interpretation: Telerehabilitation was perceived as an autonomy-supportive environment, in part by making it easier to undertake pulmonary rehabilitation. Support for behavior change, understanding, and motivation were derived from clinicians and patient-peers. The extent to which autonomy support translates into ongoing self-management and behavior change is not clear., Trial Registry: Australian and New Zealand Clinical Trials Registry; No.: ACTRN12616000360415; URL: https://anzctr.org.au/., (Copyright © 2023 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Food allergy is a significant health problem affecting approximately 8% of children and 11% of adults in the United States. It exhibits all the characteristics of a "complex" genetic trait; therefore, it is necessary to look at very large numbers of patients, far more than exist at any single organization, to eliminate gaps in the current understanding of this complex chronic disorder. Advances may be achieved by bringing together food allergy data from large numbers of patients into a Data Commons, a secure and efficient platform for researchers, comprising standardized data, available in a common interface for download and/or analysis, in accordance with the FAIR (Findable, Accessible, Interoperable, and Reusable) principles. Prior data commons initiatives indicate that research community consensus and support, formal food allergy ontology, data standards, an accepted platform and data management tools, an agreed upon infrastructure, and trusted governance are the foundation of any successful data commons. In this article, we will present the justification for the creation of a food allergy data commons and describe the core principles that can make it successful and sustainable., (Published by Elsevier Inc.)

Atopic dermatitis (AD) and food allergies are more prevalent and more severe in people with skin of color than White individuals. The American College of Allergy, Asthma, and Immunology (ACAAI) sought to understand the effects of racial disparities among patients with skin of color with AD and food allergies. The ACAAI surveyed its members (N = 200 completed), conducted interviews with health care providers and advocacy leaders, and hosted a roundtable to explore the challenges of diagnosis and management of AD and food allergies in people with skin of color and to discuss potential solutions. Most of the survey respondents (68%) agreed that racial disparities make it difficult for people with skin of color to receive adequate treatment for AD and food allergies. The interviews and roundtable identified access to care, burden of costs, policies and infrastructure that limit access to safe foods and patient education, and inadequate research involving people with skin of color as obstacles to care. Proposed solutions included identifying ways to recruit more people with skin of color into clinical trials and medical school, educating health care providers about diagnosis and treating AD and food allergy in people with skin of color, improving access to safe foods, creating and disseminating culturally appropriate materials for patients, and working toward longer appointment times for patients who need them. Challenges in AD and food allergy in persons with skin of color were identified by the ACAAI members. Solutions to these challenges were proposed to inspire actions to mitigate racial disparities in AD and food allergy., (Copyright © 2023. Published by Elsevier Inc.)

Background: The advent of Endoscopic Ear Surgery (EES) has allowed otologists an improved view of the surgical field compared with conventional Microscopic Ear Surgery (MES). EES presents different challenges for surgeons and a learning curve is necessary., Aims: The purpose of this study was to compare the efficacy of EES and MES for trans-canal tragal cartilage myringoplasty, an entry level EES., Methods: We retrospectively analysed patients who underwent push through trans-canal tragal cartilage myringoplasty in our institution over 5 years (2016-2020). Exclusion criteria were: patients with prior ear surgery, non-tragal cartilage tympanic membrane graft, additional procedure at time of surgery and patients with insufficient follow up. EES and MES groups were compared using outcomes such as graft success rate, changes in pure tone audiometry (PTA), operative time and complications., Results: Seventy-four patients met inclusion criteria (MES = 38, EES = 36). Mean age of included patients was 29.3 years with no significant demographic differences between groups. Graft success rate at 12 months was higher among the EES group versus MES (94.4% v 86.8%, p = 0.43). Mean operative time was reduced in the EES group (47.3 min v 53.8 min, p = 0.04). Hearing outcomes did not differ significantly between groups. No major operative complications occurred in either group., Conclusions: Outcomes were marginally better in the cohort who underwent EES. This supports that EES offers an otologic choice to complement established practice for trans-canal myringoplasty and may be used to facilitate introduction to EES for trainees and otologists wishing to learn this technique., Competing Interests: Declaration of competing interest The authors have no conflicts of interest to declare., (Copyright © 2022 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.)

Laryngeal malignancy encompasses about 1% of all cancers. Chondrosarcoma in the head and neck region represents about 0.1% of head and neck malignancies. Typical presenting symptoms relate to the anatomical location of these tumours and include dysphonia, inspiratory stridor, dysphagia, odynophagia or a neck mass. Benign and malignant cartilaginous cancers of the larynx have been described, and preoperative diagnosis can be difficult. Our report highlights the surgical management of a male patient in his 50s with chondrosarcoma of the thyroid cartilage., Competing Interests: Competing interests: None declared., (© BMJ Publishing Group Limited 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: & Purpose: The Irish Otolaryngology Society (IOS) conference takes place annually. This conference allows surgeons and surgical trainees from Ireland and abroad an opportunity to showcase research ideas from their respective centres. This allows them to disseminate results, accept critique, and obtain different perspectives. We sought to examine research presented at the IOS meetings over 20 years. We aimed to analyse the publication rates, impact factor of journals, and citation rates of presented abstracts., Methods: All oral presentations from IOS conferences were analysed between 2000 and 2019. Presentation titles and authors were searched using Pubmed, Google Scholar and Research Gate. We identified scientific publications which resulted from the research presented and the characteristics of each publication., Results: Of 703 presentations made at the conferences spanning 20 years, 30.15% (n = 212) went on to publish their research averaging 19 citations per publication. Median time to publication was 2 years (-1-11). Each year there have been an increasing number of oral presentations with a declining publication rate., Conclusion: The Irish otolaryngology society meeting is a high-quality meeting with comparable publication rates to similar international conferences. Despite this, many presentations do not have any lasting impact as they are not published. The increasing pressure for trainees to rapidly present research projects without emphasis on completion of projects may explain the declining publication rate. Our study highlights the importance of completing high-quality research projects through publication. Meaningful conclusions from these projects can add to the body of knowledge and contribute to evidence-based practice., Competing Interests: Declaration of competing interest There were no competing interests., (Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: Responses to the systemic treatments commonly used to treat psoriasis vary. Biomarkers that accurately predict effectiveness and safety would enable targeted treatment selection, improved patient outcomes and more cost-effective healthcare., Objectives: To perform a scoping review to identify and catalogue candidate biomarkers of systemic treatment response in psoriasis for the translational research community., Methods: A systematic search of CENTRAL, Embase, LILACS and MEDLINE was performed for relevant articles published between 1990 and December 2021. Eligibility criteria were studies involving patients with psoriasis (any age, n ≥ 50) reporting biomarkers associated with systemic treatment response. The main outcomes were any measure of systemic treatment efficacy or safety. Data were extracted by one reviewer and checked by a second; studies meeting minimal quality criteria (use of methods to control for confounding) were formally assessed for bias. Candidate biomarkers were identified by an expert multistakeholder group using a majority voting consensus exercise and mapped to relevant cellular and molecular pathways., Results: Of 71 included studies (67 studying effectiveness outcomes and eight safety outcomes; four studied both), most reported genomic or proteomic biomarkers associated with response to biologics (48 studies). Methodological or reporting limitations frequently compromised the interpretation of findings, including inadequate control for key covariates, lack of adjustment for multiple testing, and selective outcome reporting. We identified candidate biomarkers of efficacy to tumour necrosis factor inhibitors [variation in CARD14, CDKAL1, IL1B, IL12B and IL17RA loci, and lipopolysaccharide-induced phosphorylation of nuclear factor (NF)-κB in type 2 dendritic cells] and ustekinumab (HLA-C*06:02 and variation in an IL1B locus). None were supported by sufficient evidence for clinical use without further validation studies. Candidate biomarkers were found to be involved in the immune cellular crosstalk implicated in psoriasis pathogenesis, most notably antigen presentation, T helper (Th)17 cell differentiation, positive regulation of NF-κB, and Th17 cell activation., Conclusions: This comprehensive catalogue provides a key resource for researchers and reveals a diverse range of biomarker types and outcomes in the included studies. The candidate biomarkers identified require further evaluation in methodologically robust studies to establish potential clinical utility. Future studies should aim to address the common methodological limitations highlighted in this review to expedite discovery and validation of biomarkers for clinical use. What is already known about this topic? Responses to the systemic treatments commonly used to treat psoriasis vary. Biomarkers that accurately predict effectiveness and safety would enable targeted treatment selection, improved patient outcomes and more cost-effective healthcare. What does this study add? This review provides a comprehensive catalogue of investigated biomarkers of systemic treatment response in psoriasis. A diverse range of biomarker types and outcomes was found in the included studies, serving as a key resource for the translational research community., (© 2022 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.)

Background: Identification of those at risk of more severe psoriasis and/or associated morbidities offers opportunity for early intervention, reduced disease burden and more cost-effective healthcare. Prognostic biomarkers of disease progression have thus been the focus of intense research, but none are part of routine practice., Objectives: To identify and catalogue candidate biomarkers of disease progression in psoriasis for the translational research community., Methods: A systematic search of CENTRAL, Embase, LILACS and MEDLINE was performed for relevant articles published between 1990 and December 2021. Eligibility criteria were studies involving patients with psoriasis (any age, n ≥ 50) reporting biomarkers associated with disease progression. The main outcomes were any measure of skin severity or any prespecified psoriasis comorbidity. Data were extracted by one reviewer and checked by a second; studies meeting minimal quality criteria (longitudinal design and/or use of methods to control for confounding) were formally assessed for bias. Candidate biomarkers were identified by an expert multistakeholder group using a majority voting consensus exercise, and mapped to relevant cellular and molecular pathways., Results: Of 181 included studies, most investigated genomic or proteomic biomarkers associated with disease severity (n = 145) or psoriatic arthritis (n = 30). Methodological and reporting limitations compromised interpretation of findings, most notably a lack of longitudinal studies, and inadequate control for key prognostic factors. The following candidate biomarkers with future potential utility were identified for predicting disease severity: LCE3D, interleukin (IL)23R, IL23A, NFKBIL1 loci, HLA-C*06:02 (genomic), IL-17A, IgG aHDL, GlycA, I-FABP and kallikrein 8 (proteomic), tyramine (metabolomic); psoriatic arthritis: HLA-C*06:02, HLA-B*27, HLA-B*38, HLA-B*08, and variation at the IL23R and IL13 loci (genomic); IL-17A, CXCL10, Mac-2 binding protein, integrin b5, matrix metalloproteinase-3 and macrophage-colony stimulating factor (proteomic) and tyramine and mucic acid (metabolomic); and type 2 diabetes mellitus: variation in IL12B and IL23R loci (genomic). No biomarkers were supported by sufficient evidence for clinical use without further validation., Conclusions: This review provides a comprehensive catalogue of investigated biomarkers of disease progression in psoriasis. Future studies must address the common methodological limitations identified herein to expedite discovery and validation of biomarkers for clinical use. What is already known about this topic? The current treatment paradigm in psoriasis is reactive. There is a need to develop effective risk-stratified management approaches that can proactively attenuate the substantial burden of disease. Prognostic biomarkers of disease progression have therefore been the focus of intense research. What does this study add? This review is the first to scope, collate and catalogue research investigating biomarkers of disease progression in psoriasis. The review identifies potentially promising candidate biomarkers for further investigation and highlights common important limitations that should be considered when designing and conducting future studies in this area., (© 2022 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.)

In most developed nations worldwide, unintentional injury is the leading cause of death for youth 1 through 18 years. Infants are a particularly vulnerable group because motor development enables increased access to hazards, yet they are poorly equipped to assess danger. The current study compared when infants possessed low versus high motor development skills and examined the frequency and type of injury-risk behaviors and parent supervision patterns, as well as modeling how supervision influences injury-risk behaviors across motor development stages and if it does so differentially for boys and girls. Applying a participant-event monitoring method, parents were trained in completing injury-risk behavior diary forms, which they did once the child could move from their seated location on the floor in some way and continued until a month after the child could walk independently. Results revealed few differences between boys and girls in risk behaviors. The overall rate of risk behaviors was greater at high than low motor development stages and there was stability in the rate of individual infant injury-risk behaviors across motor development stages. The same general types of risk behaviors occurred over motor development stages, though about 88% of risk behaviors per se were novel and unfamiliar to parents. Parents supervised boys and girls similarly. However, model testing indicated that greater supervision increased the rate of risk behaviors longitudinally for boys but not girls. Implications for preventing injuries to boys and girls during infancy are discussed., (Copyright © 2022 Elsevier Inc. All rights reserved.)

A 60-year-old female presented with asymptomatic failing mandibular dental implants. Computed tomography (CT) showed a partially calcified, hypointense lesion within the soft tissues, measuring 1.3 x 0.8 x 1.0 cm along the buccal cortex. Incisional biopsy demonstrated a basaloid type of tumor composed of sheets of cells with plump ovoid nuclei, distinct nucleoli, and scant eosinophilic cytoplasm. Mitoses were present, averaging about 2 per 10 high power fields with scattered individual apoptotic cells. Numerous laminated calcified bodies (Liesegang rings) were observed with confluence of these bodies to form larger foci of dystrophic mineralization. These features clearly established the malignant nature of this tumor. Immunohistochemically, the tumor was positive for synaptophysin, focally positivity for CAM 5.2 and had a Ki-67 proliferation index of approximately 25%. This is the first report of a tumor with features of a malignant variant of calcifying epithelial odontogenic tumor and neuroendocrine differentiation.

Rationale: Pulmonary rehabilitation is an effective treatment for people with chronic respiratory disease but is delivered to <5% of eligible individuals. This study investigated whether home-based telerehabilitation was equivalent to centre-based pulmonary rehabilitation in people with chronic respiratory disease., Methods: A multicentre randomised controlled trial with assessor blinding, powered for equivalence was undertaken. Individuals with a chronic respiratory disease referred to pulmonary rehabilitation at four participating sites (one rural) were eligible and randomised using concealed allocation to pulmonary rehabilitation or telerehabilitation. Both programmes were two times per week for 8 weeks. The primary outcome was change in Chronic Respiratory Disease Questionnaire Dyspnoea (CRQ-D) domain at end-rehabilitation, with a prespecified equivalence margin of 2.5 points. Follow-up was at 12 months. Secondary outcomes included exercise capacity, health-related quality of life, symptoms, self-efficacy and psychological well-being., Results: 142 participants were randomised to pulmonary rehabilitation or telerehabilitation with 96% and 97% included in the intention-to-treat analysis, respectively. There were no significant differences between groups for any outcome at either time point. Both groups achieved meaningful improvement in dyspnoea and exercise capacity at end-rehabilitation. However, we were unable to confirm equivalence of telerehabilitation for the primary outcome ΔCRQ-D at end-rehabilitation (mean difference (MD) (95% CI) -1 point (-3 to 1)), and inferiority of telerehabilitation could not be excluded at either time point (12-month follow-up: MD -1 point (95% CI -4 to 1)). At end-rehabilitation, telerehabilitation demonstrated equivalence for 6-minute walk distance (MD -6 m, 95% CI -26 to 15) with possibly superiority of telerehabilitation at 12 months (MD 14 m, 95% CI -10 to 38)., Conclusion: telerehabilitation may not be equivalent to centre-based pulmonary rehabilitation for all outcomes, but is safe and achieves clinically meaningful benefits. When centre-based pulmonary rehabilitation is not available, telerehabilitation may provide an alternative programme model., Trial Registration Number: ACtelerehabilitationN12616000360415., Competing Interests: Competing interests: AEH, CFM, JAA, AM and RW, as the chief investigators, report grant funding from the National Health and Medical Research Council (NHMRC) (GNT1101616) for the conduct of this trial. NSC reports fellowship funding from the NHMRC (GNT1119970) to work on this trial. CFM reports fees paid to the institution from Menarini and AstraZeneca, and in-kind trial support from Air Liquide Healthcare—all unrelated to the present work., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Rationale: Addressing a notable gap in research on injuries during infancy, this longitudinal study examined sex differences in the relationship between parents' typical levels of supervision and infants' injuries across motor development stages., Method: Parents were recruited and completed biweekly phone calls about their infant's motor skills. Once the infant was able to sit up independently, then a home visit was scheduled. Applying a participant-event monitoring method, parents were taught to complete diary forms (injury, supervision), which they started doing once the child could move from their seated location on the floor in some way (e.g., roll, crawl). Recordings continued until a month after the child could walk independently. Data (injury, supervision) were averaged within each motor development stage (low, high), and associations across stages were examined., Results: Model testing indicated that supervision level moderated the relation between injury rate across motor development stages, but the strength of this association varied by sex of the child. More intense supervision predicted lower injury rates for girls more so than for boys., Conclusions: Although the emergence of motor milestones has been associated with increased risk of injury during infancy, the current findings indicate that greater supervision can reduce this risk. However, supervision alone is not as effective to moderate injury risk for boys as it is for girls. Thus, for boys, additional strategies (e.g., hazard removal) may also be warranted to maximize reduction in their risk of injury as they acquire increasing motor skills., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

We report a collection of lung findings in a patient with a remote history of cigarette smoking, but now engaged in heavy nicotine vaping with daily edible and combustible cannabis use. Computed tomography (CT) imaging demonstrated numerous, small, and bilateral nodules with ground-glass appearance. The largest nodule is demonstrated in the right upper lung lobe. Clinically the differential diagnosis at this time included hypersensitivity pneumonitis and sarcoidosis. Atypical infection, particularly of a fungal etiology, and metastatic malignancy were also considered. Initial pathology of the right lung needle biopsy revealed alveolar septal thickening with associated atypical pneumocyte proliferation, suggestive of atypical adenomatous hyperplasia (AAH). Subsequently the patient underwent wedge resection of the right upper, middle and lower lobes. Pathology examination revealed pulmonary Langerhans cell histiocytosis (PLCH) in the upper and lower lobes, with CD1a staining highlighting the aggregates of Langerhans cells. Vascular changes were also present including intimal thickening of muscular pulmonary arteries, consistent with pulmonary hypertensive changes. Background lung parenchyma demonstrated respiratory bronchiolitis, smoking-related interstitial fibrosis, an organizing thrombus in muscular artery and associated pneumocyte hyperplasia.

Background: Duodenal adenocarcinoma (DA) is a rare gastrointestinal malignancy. There is limited data reporting patient outcomes following radical pancreatic resection for DA. We assessed the disease-free (DFS) and overall survival (OS) in patients undergoing pancreaticoduodenectomy for DA in our institution., Methods: We retrospectively analysed all patients undergoing pancreatic resection of DA at our institution between January 2009 and March 2020 inclusive., Results: Ninteen patients underwent pancreatic resection at our institution for DA during the study period. The overall postoperative morbidity and mortality was 37% and 5%, respectively. Nine patients (47%) had no nodal involvement. Median follow up was 25 months (range 1-108 months). Median DFS for our whole cohort was 17 months but was significantly higher in patients with no nodal metastasis [p < 0.001]. Median OS was 9.5 months for the whole cohort but was significantly higher in the patients with no nodal metastasis (60 months) compared to those with nodal metastasis (17.5 months) [p < 0.003]., Conclusion: Improved DFS and OS for patients undergoing pancreaticoduodenectomy for DAs is associated with lymph node negative disease., (© 2022 Royal Australasian College of Surgeons.)

A man in his 30s with primary hyperparathyroidism underwent an elective four-gland parathyroid exploration with intraoperative parathyroid hormone monitoring. On the fourth postoperative day (POD), the patient presented to the emergency department with severe symptomatic hypocalcaemia. ECG findings were in keeping with inferior-posterior ST-elevation myocardial infarction (STEMI); however, he was asymptomatic with no chest pain. Biochemistry revealed elevated serial troponin levels. Coronary angiogram and transthoracic echocardiogram were normal, suggesting coronary vasospasm, mimicking STEMI on ECG because of severe hypocalcaemia post parathyroidectomy. This is an uncommon and unreported complication of parathyroid surgery. The patient was successfully managed with intravenous calcium and discharged on oral calcium replacement on the tenth POD., Competing Interests: Competing interests: None declared., (© BMJ Publishing Group Limited 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Despite investigation, 95% of thyroid nodules are ultimately benign. Radiomics is a field that uses radiological features to inform individualized patient care. We aimed to evaluate the diagnostic utility of radiomics in classifying undetermined thyroid nodules into benign and malignant using ultrasonography (US). Methods: A diagnostic test accuracy systematic review and meta-analysis was performed in accordance with PRISMA guidelines. Sensitivity, specificity, and area under curve (AUC) delineating benign and malignant lesions were recorded. Results: Seventy-five studies including 26,373 patients and 46,175 thyroid nodules met inclusion criteria. Males accounted for 24.6% of patients, while 75.4% of patients were female. Radiomics provided a pooled sensitivity of 0.87 (95% CI: 0.86−0.87) and a pooled specificity of 0.84 (95% CI: 0.84−0.85) for characterizing benign and malignant lesions. Using convolutional neural network (CNN) methods, pooled sensitivity was 0.85 (95% CI: 0.84−0.86) and pooled specificity was 0.82 (95% CI: 0.82−0.83); significantly lower than studies using non-CNN: sensitivity 0.90 (95% CI: 0.89−0.90) and specificity 0.88 (95% CI: 0.87−0.89) (p < 0.05). The diagnostic ability of radiologists and radiomics were comparable for both sensitivity (OR 0.98) and specificity (OR 0.95). Conclusions: Radiomic analysis using US provides a reproducible, reliable evaluation of undetermined thyroid nodules when compared to current best practice.

Introduction: Ear, nose and throat (ENT) specialists are a high-risk group for COVID-19. Although the implications of SARS-CoV-2 infection on physical health are well-documented, the psychological impact is frequently overlooked., Aims: The aim of this study was to gauge the psychological impact of COVID-19 on ENT specialists in Ireland., Methods: A national, cross-sectional, web-based survey was distributed to ENT specialists during the peak of the COVID-19 pandemic (21 st May 2020-21 st June 2020). The questionnaire collected sociodemographic and COVID-19 related data. The GAD-7 was utilized to measure symptoms of clinically significant anxiety disorder., Results: Thirty-eight ENT specialists (M/F:24/12, median age, 38.7 years (23-60 years)) completed the survey. About 34% (n = 13) of participants screened positive for an anxiety disorder, of which 2 (5%) had moderate symptoms. The majority of participants (n = 32, 84%) felt ENT specialists had increased exposure to SARS-CoV-2 compared with other medical specialties. Additionally, 32% (n = 12) felt incapable of protecting themselves from infection. An encouraging proportion of ENT specialists (n = 22, 58%) were aware of psychological support available from national and institutional organizations., Conclusions: The long-term psychological sequelae of COVID-19 will be felt as the physical burden eases. As we adjust to new normalities, ENT surgeons must be conscientious of the mental health issues that arise from the working environment. Sources of anxiety emanated from a lack of control over infection risk, increased vulnerability to COVID-19 relative to other specialties and the implications this has for ENT specialists and their families. Future interventions must focus on increasing awareness of the available psychological support services for our healthcare workers., (© 2021. Royal Academy of Medicine in Ireland.)

Background: Odontogenic sinusitis is a common cause of rhinosinusitis that is often undiagnosed and overlooked. No single sign or symptom is specific for odontogenic sinusitis, and failure to focus on the specific radiological features can delay diagnosis., Objective: This paper presents four cases of chronic sinusitis that had an odontogenic origin. Each case was referred for a second opinion. Three patients had previously undergone unsuccessful surgical management., Methods: The literature, and the associated contributory clinical, radiological and microbiological features required for correct diagnosis and management, are reviewed., Results: Each case resulted in a positive patient outcome following the involvement of both otolaryngology and maxillofacial surgery departments., Conclusion: A high index of suspicion is advocated for odontogenic sinusitis in cases not responding to standard management plans. Collaboration with a maxillofacial specialist is important for diagnosis and management. This should be considered where standard management fails, or clinical features and radiological signs of odontogenic sinusitis are present. This paper also highlights the need for otolaryngologists to incorporate, at the very least, a basic dental history and examination as part of their assessment in recalcitrant cases.

Background: New-onset atrial fibrillation occurs in around 10% of adults treated in an intensive care unit. New-onset atrial fibrillation may lead to cardiovascular instability and thromboembolism, and has been independently associated with increased length of hospital stay and mortality. The long-term consequences are unclear. Current practice guidance is based on patients outside the intensive care unit; however, new-onset atrial fibrillation that develops while in an intensive care unit differs in its causes and the risks and clinical effectiveness of treatments. The lack of evidence on new-onset atrial fibrillation treatment or long-term outcomes in intensive care units means that practice varies. Identifying optimal treatment strategies and defining long-term outcomes are critical to improving care., Objectives: In patients treated in an intensive care unit, the objectives were to (1) evaluate existing evidence for the clinical effectiveness and safety of pharmacological and non-pharmacological new-onset atrial fibrillation treatments, (2) compare the use and clinical effectiveness of pharmacological and non-pharmacological new-onset atrial fibrillation treatments, and (3) determine outcomes associated with new-onset atrial fibrillation., Methods: We undertook a scoping review that included studies of interventions for treatment or prevention of new-onset atrial fibrillation involving adults in general intensive care units. To investigate the long-term outcomes associated with new-onset atrial fibrillation, we carried out a retrospective cohort study using English national intensive care audit data linked to national hospital episode and outcome data. To analyse the clinical effectiveness of different new-onset atrial fibrillation treatments, we undertook a retrospective cohort study of two large intensive care unit databases in the USA and the UK., Results: Existing evidence was generally of low quality, with limited data suggesting that beta-blockers might be more effective than amiodarone for converting new-onset atrial fibrillation to sinus rhythm and for reducing mortality. Using linked audit data, we showed that patients developing new-onset atrial fibrillation have more comorbidities than those who do not. After controlling for these differences, patients with new-onset atrial fibrillation had substantially higher mortality in hospital and during the first 90 days after discharge (adjusted odds ratio 2.32, 95% confidence interval 2.16 to 2.48; adjusted hazard ratio 1.46, 95% confidence interval 1.26 to 1.70, respectively), and higher rates of subsequent hospitalisation with atrial fibrillation, stroke and heart failure (adjusted cause-specific hazard ratio 5.86, 95% confidence interval 5.33 to 6.44; adjusted cause-specific hazard ratio 1.47, 95% confidence interval 1.12 to 1.93; and adjusted cause-specific hazard ratio 1.28, 95% confidence interval 1.14 to 1.44, respectively), than patients who did not have new-onset atrial fibrillation. From intensive care unit data, we found that new-onset atrial fibrillation occurred in 952 out of 8367 (11.4%) UK and 1065 out of 18,559 (5.7%) US intensive care unit patients in our study. The median time to onset of new-onset atrial fibrillation in patients who received treatment was 40 hours, with a median duration of 14.4 hours. The clinical characteristics of patients developing new-onset atrial fibrillation were similar in both databases. New-onset atrial fibrillation was associated with significant average reductions in systolic blood pressure of 5 mmHg, despite significant increases in vasoactive medication (vasoactive-inotropic score increase of 2.3; p  < 0.001). After adjustment, intravenous beta-blockers were not more effective than amiodarone in achieving rate control (adjusted hazard ratio 1.14, 95% confidence interval 0.91 to 1.44) or rhythm control (adjusted hazard ratio 0.86, 95% confidence interval 0.67 to 1.11). Digoxin therapy was associated with a lower probability of achieving rate control (adjusted hazard ratio 0.52, 95% confidence interval 0.32 to 0.86) and calcium channel blocker therapy was associated with a lower probability of achieving rhythm control (adjusted hazard ratio 0.56, 95% confidence interval 0.39 to 0.79) than amiodarone. Findings were consistent across both the combined and the individual database analyses., Conclusions: Existing evidence for new-onset atrial fibrillation management in intensive care unit patients is limited. New-onset atrial fibrillation in these patients is common and is associated with significant short- and long-term complications. Beta-blockers and amiodarone appear to be similarly effective in achieving cardiovascular control, but digoxin and calcium channel blockers appear to be inferior., Future Work: Our findings suggest that a randomised controlled trial of amiodarone and beta-blockers for management of new-onset atrial fibrillation in critically ill patients should be undertaken. Studies should also be undertaken to provide evidence for or against anticoagulation for patients who develop new-onset atrial fibrillation in intensive care units. Finally, given that readmission with heart failure and thromboembolism increases following an episode of new-onset atrial fibrillation while in an intensive care unit, a prospective cohort study to demonstrate the incidence of atrial fibrillation and/or left ventricular dysfunction at hospital discharge and at 3 months following the development of new-onset atrial fibrillation should be undertaken., Trial Registration: Current Controlled Trials ISRCTN13252515., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 25, No. 71. See the NIHR Journals Library website for further project information.

Introduction: Chronic obstructive pulmonary disease (COPD) is characterised by exacerbations of respiratory disease, frequently requiring hospital admission. Pulmonary rehabilitation can reduce the likelihood of future hospitalisation, but programme uptake is poor. This study aims to compare hospital readmission rates, clinical outcomes and costs between people with COPD who undertake a home-based programme of pulmonary rehabilitation commenced early (within 2 weeks) of hospital discharge with usual care., Methods: A multisite randomised controlled trial, powered for superiority, will be conducted in Australia. Eligible patients admitted to one of the participating sites for an exacerbation of COPD will be invited to participate. Participants will be randomised 1:1. Intervention group participants will undertake an 8-week programme of home-based pulmonary rehabilitation commencing within 2 weeks of hospital discharge. Control group participants will receive usual care and a weekly phone call for attention control. Outcomes will be measured by a blinded assessor at baseline, after the intervention (week 9-10 posthospital discharge), and at 12 months follow-up. The primary outcome is hospital readmission at 12 months follow-up., Ethics and Dissemination: Human Research Ethics approval for all sites provided by Alfred Health (Project 51216). Findings will be published in peer-reviewed journals, conferences and lay publications., Trial Registration Number: ACTRN12619001122145., Competing Interests: Competing interests: NSC and AEH: declare grant funding from the NHMRC paid to their institution for the conduct of the trial. CFM declares board roles as Chair COPD National Program, Lung Foundation Australia; and Medical Director Institute for Breathing and Sleep. For all other authors, no competing interests are declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

This article describes the October 2020 proceedings of the Million Hearts Cardiac Rehabilitation Think Tank: Accelerating New Care Models, convened with representatives from professional organizations, cardiac rehabilitation (CR) programs, academic institutions, federal agencies, payers, and patient representative groups. As CR delivery evolves, terminology is evolving to reflect not where activities occur (eg, center, home) but how CR is delivered: in-person synchronous, synchronous with real-time audiovisual communication (virtual), or asynchronous (remote). Patients and CR staff may interact through ≥1 delivery modes. Though new models may change how CR is delivered and who can access CR, new models should not change what is delivered-a multidisciplinary program addressing CR core components. During the coronavirus disease 2019 (COVID-19) public health emergency, Medicare issued waivers to allow virtual CR; it is unclear whether these waivers will become permanent policy post-public health emergency. Given CR underuse and disparities in delivery, new models must equitably address patient and health system contributors to disparities. Strategies for implementing new CR care models address safety, exercise prescription, monitoring, and education. The available evidence supports the efficacy and safety of new CR care models. Still, additional research should study diverse populations, impact on patient-centered outcomes, effect on long-term outcomes and health care utilization, and implementation in diverse settings. CR is evolving to include in-person synchronous, virtual, and remote modes of delivery; there is significant enthusiasm for implementing new care models and learning how new care models can broaden access to CR, improve patient outcomes, and address health inequities.