Building America research benchmark definition: Updated December 2009

To track progress toward aggressive multi-year, whole-house energy savings goals of 40%–70% and on-site power production of up to 30%, the U.S. Department of Energy (DOE) Residential Buildings Program and the National Renewable Energy Laboratory (NREL) developed the Building America (BA) Research Benchmark in consultation with the Building America industry teams. The Benchmark is generally consistent with mid-1990s standard practice, as reflected in the Home Energy Rating System (HERS) Technical Guidelines (RESNET 2002), with additional definitions that allow the analyst to evaluate all residential end uses, an extension of the traditional HERS rating approach that focuses on space conditioning and hot water. Unlike the reference homes used for HERS, ENERGY STAR, and most energy codes, the Benchmark represents typical construction at a fixed point in time so it can be used as the basis for Building America’s multi-year energy savings goals without the complication of chasing a “moving target.” As time passes, we expect energy codes to become more and more energy efficient compared to the Benchmark as better construction practices and more efficient equipment become commonplace in the market. A series of user profiles, intended to represent the behavior of a “standard” set of occupants, was created for use in conjunction with the Benchmark. The Benchmark is intended for use with detached and attached single-family housing, as well as multi-family housing. Energy analysis of a Prototype compared to the Benchmark can be performed with any software tool that complies with the BA Performance Analysis Procedures (Hendron et al. 2004). In addition, NREL will provide examples of technology packages that can be used to achieve different source energy savings based on BEopt analysis results (Anderson and Roberts 2008). These technology packages, or alternative packages that provide equivalent source energy savings, may be used to demonstrate minimum whole house source energy savings for BA Gate reviews

Test Protocol for Room-to-Room Distribution of Outside Air by Residential Ventilation Systems

This test and analysis protocol has been developed as a practical approach for measuring outside air distribution in homes. It has been used successfully in field tests and has led to significant insights on ventilation design issues. Performance advantages of more sophisticated ventilation systems over simpler, less-costly designs have been verified, and specific problems, such as airflow short-circuiting, have been identified

Patient-reported Quality of Life outcomes in patients treated for muscle-invasive bladder cancer with radiotherapy ± chemotherapy in the BC2001 Phase III Randomised Controlled Trial

BC2001, the largest randomised trial of bladder-sparing treatment for muscle-invasive bladder cancer, demonstrated improvement of local control and bladder cancer-specific survival from the addition of concomitant 5-fluorouracil and mitomycin C to radiotherapy.This article is available via Open Access. Click on the Publisher URL to access the full-text

Evaluating quality and impact of acute paediatric inpatient care: Defining the domains for a Person Centred Outcome Measure (PCOM) in children and young people admitted with self-harm or eating disorders

Background and purpose: In the United Kingdom, the prevalence of children and young people (CYP), up to the age of 18 years, accessing acute paediatric inpatient care with mental health problems is increasing, with self-harm and eating disorders particularly prevalent. This initial period of acute inpatient care can involve multiple assessments and interventions in order to meet physical, psychological and social needs. However, there is a distinct paucity of published literature reporting CYP service users’ experiences and outcomes of being in receipt of non-specialist inpatient care. Therefore this project aimed to undertake the preliminary work in developing a Person Centred Outcome Measure (PCOM) for this patient group by identifying the domains for a PCOM and establishing how such a measure could be implemented. Methods: A two phase sequential design was adopted which involved: (1) a rapid review of the literature and (2) an evaluation of experiences and outcomes through stakeholder engagement events with children and young people admitted with self-harm or eating disorders, their parents and carers, and professionals from health, social care and education. Findings: Rapid review of the literature • There is a lack of reported outcomes relating to CYP admitted to inpatient care with self-harm within the literature. • Outcomes reported by CYP appear to relate to aspects of care delivery, communication and the inpatient environment; • CYP reports predominantly relate to deficits in service provision which is recognised to negatively impact on experience and inhibit recovery and outcome. Findings: Stakeholder workshops • In total 96 CYP, parents and carers, and professionals participated in the stakeholder event. • Disparities in experiences and the implied quality of being in receipt of care were identified. • Synthesis of findings identified five domains that could be used to develop a PCOM that included: Privacy and surveillance; Receiving holistic care; Making choices and being understood through timely, relevant and appropriate communication; Working together to plan and achieve care goals; and Respect and empowerment • Variation was evident between CYP stakeholders as to the acceptability of when and how outcomes are measured. Conclusion: Findings from this project provide the foundations for a PCOM for CYP admitted to acute paediatric care with self harm or eating disorders to be developed, tested, implemented and evaluated. The domains identified have the potential to be further developed and validated as an instrument with a larger and more diverse sample of CYP

TUXEDO: a phase I/II trial of cetuximab with chemoradiotherapy in muscle-invasive bladder cancer

Objective: To assess the feasibility and preliminary efficacy of adding cetuximab to standard chemoradiotherapy for muscle-invasive bladder cancer. Patients and Methods: TUXEDO was a prospective, single-arm, open-label, phase I/II trial conducted in six UK hospitals. Cetuximab was administered with an initial loading dose of 400 mg/m2 on Day 1 of Week −1, and then seven weekly doses of 250 mg/m2. The radiotherapy schedule was 64 Gy/32F with Day 1 mitomycin C (12 g/m2) and 5-fluorouracil (500 mg/m2/day) over Days 1–5 and Days 22–26. Patients with T2-4aN0M0 urothelial cancer and a performance status of 0–1 were eligible. Prior neoadjuvant therapy was permitted. The Phase I primary outcome was impact on radiotherapy treatment completion and toxicity experienced during treatment. The Phase II primary outcome was local control at 3 months post treatment. Results: Between September 2012 and October 2016, 33 patients were recruited; seven in Phase I, 26 in Phase II. Three patients in Phase II were subsequently deemed ineligible and received no trial therapy. Eight patients discontinued cetuximab due to adverse effects. The patients’ median (range) age was 70.1 (60.6–75.1) years, 20 had a performance status of 0, 27 were male and 26 had already received neoadjuvant chemotherapy. In Phase I, all patients completed planned radiotherapy, with no delays or dose reductions. Of the 30 evaluable patients in Phase II, 25 had confirmed local control 3 months after treatment (77%, 95% confidence interval 58–90). During the trial there were 18 serious adverse events. The study was halted due to slow accrual. Conclusion: Phase I data demonstrate it is feasible and safe to add cetuximab to chemoradiotherapy. Exploratory analysis of Phase II data provides evidence to consider further clinical evaluation of cetuximab in this setting

Developing a prototype digital risk mitigation pathway for children and young people admitted to acute paediatric NHS care in mental health crisis: Protocol of the Safety Assessment in Paediatric healthcare Environments (SAPhE) pathway study

Background: Globally, there are increasing numbers of Children and young people (CYPs) experiencing a mental health crisis requiring admission to acute paediatric inpatient care. These CYPs can often experience fluctuating emotional states accompanied by urges to self-harm or attempt to end their life, leading to reduced safety and poorer experiences. Currently, in the UK National Health Service (NHS) there are no standardised, evidence-based interventions in acute paediatric care to mitigate or minimise immediate risk of self-harm and suicide in CYP admitted with mental health crisis. Objective: To outline the protocol for the SAPhE Pathway study which aims to: 1) identify and prioritise risk mitigation strategies to include in the digital prototype, 2) understand the feasibility of implementing a novel digital risk mitigation pathway in differing NHS contexts, and 3) co-create a prototype digital risk mitigation pathway. Methods: This is a multi-centre study uses a mixed-methods design. A systematic review and exploratory methods (interviews, surveys, and focus groups) will be used to identify the content and feasibility of implementing a digital risk mitigation pathway. Participants will include healthcare professionals, digital experts and CYP with experience of mental health conditions. Data will be collected between January 2022 and March 2023 and analysed using content and thematic analysis, case study, cross-case analysis for qualitative data and descriptive statistics for quantitative data. Findings will inform the experience-based co-design workshops. Ethics and Dissemination: The study received full ethical approval from NHS REC [Ref: 22/SC/0237 and 22/WM/0167]. Findings will be made available to all stakeholders using multiple approaches

TUXEDO: a phase I/II trial of cetuximab with chemoradiotherapy in muscle‐invasive bladder cancer.

Objective To assess the feasibility and preliminary efficacy of adding cetuximab to standard chemoradiotherapy for muscle-invasive bladder cancer. Patients and Methods TUXEDO was a prospective, single-arm, open-label, phase I/II trial conducted in six UK hospitals. Cetuximab was administered with an initial loading dose of 400 mg/m2 on Day 1 of Week −1, and then seven weekly doses of 250 mg/m2. The radiotherapy schedule was 64 Gy/32F with Day 1 mitomycin C (12 g/m2) and 5-fluorouracil (500 mg/m2/day) over Days 1–5 and Days 22–26. Patients with T2-4aN0M0 urothelial cancer and a performance status of 0–1 were eligible. Prior neoadjuvant therapy was permitted. The Phase I primary outcome was impact on radiotherapy treatment completion and toxicity experienced during treatment. The Phase II primary outcome was local control at 3 months post treatment. Results Between September 2012 and October 2016, 33 patients were recruited; seven in Phase I, 26 in Phase II. Three patients in Phase II were subsequently deemed ineligible and received no trial therapy. Eight patients discontinued cetuximab due to adverse effects. The patients’ median (range) age was 70.1 (60.6–75.1) years, 20 had a performance status of 0, 27 were male and 26 had already received neoadjuvant chemotherapy. In Phase I, all patients completed planned radiotherapy, with no delays or dose reductions. Of the 30 evaluable patients in Phase II, 25 had confirmed local control 3 months after treatment (77%, 95% confidence interval 58–90). During the trial there were 18 serious adverse events. The study was halted due to slow accrual. Conclusion Phase I data demonstrate it is feasible and safe to add cetuximab to chemoradiotherapy. Exploratory analysis of Phase II data provides evidence to consider further clinical evaluation of cetuximab in this setting

Updated Guidance Regarding The Risk ofAllergic Reactions to COVID-19 Vaccines and Recommended Evaluation and Management: A GRADE Assessment, and International Consensus Approach

This guidance updates 2021 GRADE (Grading of Recommendations Assessment, Development and Evaluation) recommendations regarding immediate allergic reactions following coronavirus disease 2019 (COVID-19) vaccines and addresses revaccinating individuals with first-dose allergic reactions and allergy testing to determine revaccination outcomes. Recent meta-analyses assessed the incidence of severe allergic reactions to initial COVID-19 vaccination, risk of mRNA-COVID-19 revaccination after an initial reaction, and diagnostic accuracy of COVID-19 vaccine and vaccine excipient testing in predicting reactions. GRADE methods informed rating the certainty of evidence and strength of recommendations. A modified Delphi panel consisting of experts in allergy, anaphylaxis, vaccinology, infectious diseases, emergency medicine, and primary care from Australia, Canada, Europe, Japan, South Africa, the United Kingdom, and the United States formed the recommendations. We recommend vaccination for persons without COVID-19 vaccine excipient allergy and revaccination after a prior immediate allergic reaction. We suggest against \u3e 15-minute postvaccination observation. We recommend against mRNA vaccine or excipient skin testing to predict outcomes. We suggest revaccination of persons with an immediate allergic reaction to the mRNA vaccine or excipients be performed by a person with vaccine allergy expertise in a properly equipped setting. We suggest against premedication, split-dosing, or special precautions because of a comorbid allergic history