Ethical considerations in quality improvement: key questions and a practical guide.

Quality improvement (QI) provides a rigorous and innovative approach to improving patient's lives in the healthcare system. Still, it can pose challenges in understanding what ethical considerations apply to some projects to minimise the possibility of patient harm or prevent other ethical wrongs and potential staff burden. While many commentaries discuss the extent to which QI ethics should match research ethics, there is minimal literature regarding what QI project teams should do when considering ethics at the planning stage.

Comparison of clinical rating scales in genetic frontotemporal dementia within the GENFI cohort.

Background: Therapeutic trials are now underway in genetic forms of frontotemporal dementia (FTD) but clinical outcome measures are limited. The two most commonly used measures, the Clinical Dementia Rating (CDR)+National Alzheimer's Disease Coordinating Center (NACC) Frontotemporal Lobar Degeneration (FTLD) and the FTD Rating Scale (FRS), have yet to be compared in detail in the genetic forms of FTD.

Methods: The CDR+NACC FTLD and FRS were assessed cross-sectionally in 725 consecutively recruited participants from the Genetic FTD Initiative: 457 mutation carriers (77 microtubule-associated protein tau (, 187 , 193 ) and 268 family members without mutations (non-carrier control group).

Changes in daily mental health service use and mortality at the commencement and lifting of COVID-19 'lockdown' policy in 10 UK sites: a regression discontinuity in time design.

Objectives: To investigate changes in daily mental health (MH) service use and mortality in response to the introduction and the lifting of the COVID-19 'lockdown' policy in Spring 2020.

Design: A regression discontinuity in time (RDiT) analysis of daily service-level activity.

Setting And Participants: Mental healthcare data were extracted from 10 UK providers.

Regional forecasting of COVID-19 caseload by non-parametric regression: a VAR epidemiological model.

Objectives: The COVID-19 pandemic (caused by SARS-CoV-2) has introduced significant challenges for accurate prediction of population morbidity and mortality by traditional variable-based methods of estimation. Challenges to modelling include inadequate viral physiology comprehension and fluctuating definitions of positivity between national-to-international data. This paper proposes that accurate forecasting of COVID-19 caseload may be best preformed non-parametrically, by vector autoregression (VAR) of verifiable data regionally.

Performance and impact of disposable and reusable respirators for healthcare workers during pandemic respiratory disease: a rapid evidence review.

Objectives: To synthesise evidence concerning the range of filtering respirators suitable for patient care and guide the selection and use of different respirator types.

Design: Comparative analysis of international standards for respirators and rapid review of their performance and impact in healthcare.

Data Sources: Websites of international standards organisations, Medline and Embase, hand-searching of references and citations.

TriMaster: randomised double-blind crossover study of a DPP4 inhibitor, SGLT2 inhibitor and thiazolidinedione as second-line or third-line therapy in patients with type 2 diabetes who have suboptimal glycaemic control on metformin treatment with or without a sulfonylurea-a MASTERMIND study protocol.

Introduction: Pharmaceutical treatment options for patients with type 2 diabetes mellitus (T2DM) have increased to include multiple classes of oral glucose-lowering agents but without accompanying guidance on which of these may most benefit individual patients. Clinicians lack information for treatment intensification after first-line metformin therapy. Stratifying patients by simple clinical characteristics may improve care by targeting treatment options to those in whom they are most effective.

Acute pseudogout presenting as an exception to Musculoskeletal Infection Society criteria in total knee arthroplasty: a case report.

In this case, a 78-year-old female with no previous medical history of crystalline arthropathy presented with pain, effusion, and erythema about a total knee arthroplasty (TKA) performed 13 years prior. Implementation of a novel synovial fluid alpha-defensin assay ruled out periprosthetic joint infection (PJI) despite a positive 2018 Musculoskeletal Infection Society (MSIS) minor criteria score of 8 points, a significant diagnostic differentiation which prevented secondary invasive debridement or joint irrigation intervention. Confirmatory histologic study was positive for calcium pyrophosphate crystals, indicative of acute pseudogout inflammation rather than PJI or septic arthritis manifestation.

Industry ties and evidence in public comments on the FDA framework for modifications to artificial intelligence/machine learning-based medical devices: a cross sectional study.

Objectives: To determine the extent and disclosure of financial ties to industry and use of scientific evidence in comments on a US Food and Drug Administration (FDA) regulatory framework for modifications to artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD).

Design: Cross-sectional study.

Setting: We searched all publicly available comments on the FDA 'Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)-Discussion Paper and Request for Feedback' from 2 April 2019 to 8 August 2019.

Identifying factors associated with spontaneous restoration of hearing in children with otitis media with effusion.

Objectives: To identify predictors of acceptable hearing at 5 weeks, 6 and 12 months in children with bilateral otitis media with effusion (OME).

Design And Setting: Secondary analysis of OSTRICH data, conducted in hospital ear, nose and throat (ENT) and paediatric audiology and audiovestibular medicine departments across Wales and England.

Participants: The OSTRICH study included 389 children aged 2-8 years with bilateral hearing loss attributable toOME for at least 3 months.

Selective and non-selective bottlenecks as drivers of the evolution of hypermutable bacterial loci.

Bottlenecks reduce the size of the gene pool within populations of all life forms with implications for their subsequent survival. Here, we examine the effects of bottlenecks on bacterial commensal-pathogens during transmission between, and dissemination within, hosts. By reducing genetic diversity, bottlenecks may alter individual or population-wide adaptive potential.

Degloving injury to groin, scrotum and penis due to low-velocity handlebar injury.

Bicycles are a common cause of blunt abdominal trauma causing 5%-14% of injuries. However, impalement or shear injuries from low-velocity mechanism of injury are rare. We report a case of a 14-year-old boy presenting with an extensive left groin injury sustained while cycling one-handed along the pavement at walking pace.

Exercise- and strategy-based physiotherapy-delivered intervention for preventing repeat falls in people with Parkinson's: the PDSAFE RCT.

Background: People with Parkinson's disease are twice as likely to experience a fall as a healthy older person, often leading to debilitating effects on confidence, activity levels and quality of life.

Objective: To estimate the effect of a physiotherapy programme for fall prevention among people with Parkinson's disease.

Design: A multicentre, pragmatic, investigator-masked, individually randomised controlled trial (RCT) with prespecified subgroup analyses.

The evolving role of paramedics - a NICE problem to have?

This short essay supports the growing role of paramedics in the clinical and academic workforce. We present a commentary of recent draft consultations by the National Institute for Health and Care Excellence in England that set out how the role of paramedics may be evolving to assist with the changing demands on the clinical workforce. Using these consultations as a basis, we extend their recommendations and suggest that the profession should also lead the academically driven evaluation of these new roles.

Intermittent catatonia and complex automatisms caused by frontal lobe epilepsy in dementia.

An 82-year-old man was admitted to the emergency department following bizarre behaviour. Police had noticed him driving erratically through his village. He did not stop when instructed, drove slowly home and appeared 'vacant' on questioning.

The impact of bottlenecks on microbial survival, adaptation, and phenotypic switching in host-pathogen interactions.

Microbial pathogens and viruses can often maintain sufficient population diversity to evade a wide range of host immune responses. However, when populations experience bottlenecks, as occurs frequently during initiation of new infections, pathogens require specialized mechanisms to regenerate diversity. We address the evolution of such mechanisms, known as stochastic phenotype switches, which are prevalent in pathogenic bacteria.

Iminosugars: Promising therapeutics for influenza infection.

Influenza virus causes three to five million severe respiratory infections per year in seasonal epidemics, and sporadic pandemics, three of which occurred in the twentieth century and are a continuing global threat. Currently licensed antivirals exclusively target the viral neuraminidase or M2 ion channel, and emerging drug resistance necessitates the development of novel therapeutics. It is believed that a host-targeted strategy may combat the development of antiviral drug resistance.