Pexidartinib and standard neoadjuvant therapy in the adaptively randomized I-SPY2 trial for early breast cancer.

Purpose: We investigated the small-molecule receptor tyrosine kinase-inhibitor of colony-stimulating factor-1 receptor pexidartinib in the stage II/III breast cancer in the I-SPY2 platform trial.

Methods: I-SPY2 is an adaptive platform trial that features multiple arms of experimental agents administered on a background of standard neoadjuvant therapy with paclitaxel and adriamycin/cyclophosphamide, followed by definitive surgery. The adaptive randomization engine preferentially assigns patients based upon cumulative performance of each agent in a given breast cancer subtype based on hormone receptor and HER2 receptor status.

Patients With First-Time or Recurrent Patellar Dislocation Have a Similar High Rate and Extent of Articular Cartilage Injury Observed on Magnetic Resonance Imaging.

Purpose: To use magnetic resonance imaging (MRI) scans to compare the prevalence of articular cartilage damage in patients with a single patellar dislocation versus those with multiple dislocations and to compare the locations and severity of chondral injury between the groups.

Methods: Patients with patellar dislocation between January 2017 and July 2021 were retrospectively identified. Patients with a documented history of patellar dislocation and an MRI scan of the affected knee were included.

Pilot and feasibility studies: extending the conceptual framework.

In 2016, we published a conceptual framework outlining the conclusions of our work in defining pilot and feasibility studies. Since then, the CONSORT extension to randomised pilot and feasibility trials has been published and there have been further developments in the pilot study landscape. In this paper, we revisit and extend our framework to incorporate the various feasibility pathways open to researchers, which include internal pilot studies.

A Life or "Good Death" Situation? A Worldwide Ecological Study of the National Contexts of Countries That Have and Have Not Implemented Palliative Care.

Context: Palliative care advocates argue that service implementation is feasible in all settings. Yet, services have developed patchily in low- and middle-income settings. Beyond Human Development Index indicators, there has been limited engagement with the broader development challenges facing nations tasked with implementing palliative care.

Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration.

This report presents the Consolidated Standards of Reporting Trials (CONSORT) extension for the stepped wedge cluster randomised trial (SW-CRT). The SW-CRT involves randomisation of clusters to different sequences that dictate the order (or timing) at which each cluster will switch to the intervention condition. The statement was developed to allow for the unique characteristics of this increasingly used study design.

Emergency hospital care for adults with suspected seizures in the NHS in England 2007-2013: a cross-sectional study.

Aims: To quantify the frequency, characteristics, geographical variation and costs of emergency hospital care for suspected seizures.

Design: Cross-sectional study using routinely collected data (Hospital Episode Statistics).

Setting: The National Health Service in England 2007-2013.

Severe acute malnutrition in children aged under 5 years can be successfully managed in a non-emergency routine community healthcare setting in Ghana.

This study investigated the performance of community-based management of severe acute malnutrition (CMAM) within routine healthcare services in Ghana. This was a retrospective cohort study of n = 488 children (6-59 months) who had received CMAM. Data for recovery, default, and mortality rates were obtained from enrolment cards in 56 outpatient centres in Upper East region, Ghana.

What do hospital mortality rates tell us about quality of care?

Hospital mortality rates could be useful indicators of quality of care, but careful statistical analysis is required to avoid erroneously attributing variation in mortality to differences in health care when it is actually due to differences in case mix. The summary hospital mortality indicator is currently used by the English National Health Service (NHS). It adjusts mortality rates up to 30 days after discharge for patient age, sex, type of admission, year of discharge, comorbidity, deprivation and diagnosis.

Good practice guidelines for the use of statistical regression models in economic evaluations.

Decision-analytic models (DAMs) used to evaluate the cost effectiveness of interventions are pivotal sources of evidence used in economic evaluations. Parameter estimates used in the DAMs are often based on the results of a regression analysis, but there is little guidance relating to these. This study had two objectives.

Patients' experience and satisfaction with GP led walk-in centres in the UK; a cross sectional study.

Background: GP led walk-in centres were established in the UK in 2009. Around 150 such clinics were initially planned to open. Their purpose is to provide a primary health care service to complement the urgent care services provided by Emergency Departments (ED), to reduce unnecessary patient attendance at ED, and to increase accessibility of health care services.

The 5x1 DAFNE study protocol: a cluster randomised trial comparing a standard 5 day DAFNE course delivered over 1 week against DAFNE training delivered over 1 day a week for 5 consecutive weeks.

Background: Structured education programmes are now established as an essential component to assist effective self-management of diabetes. In the case of Type 1 diabetes, the Dose Adjustment For Normal Eating (DAFNE) programme improves both glycaemic control and quality of life. Traditionally delivered over five consecutive days, this format has been cited as a barrier to participation by some patients, such as those who work full-time.

Cognitive behavioural intervention for adults with anxiety complications of asthma: prospective randomised trial.

Background: High levels of asthma-related fear and panic exacerbate asthma symptoms and complicate the management of asthma. Asthma-specific fear may be reduced by a cognitive behavioural intervention. We aimed to test if there is a reduction in asthma-specific fear after cognitive behavioural intervention compared with routine treatment.

A pragmatic quasi-experimental multi-site community intervention trial evaluating the impact of Emergency Care Practitioners in different UK health settings on patient pathways (NEECaP Trial).

Background: Emergency Care Practitioners (ECPs) are operational in the UK in a variety of emergency and urgent care settings. However, there is little evidence of the effectiveness of ECPs within these different settings. The aim of this study was to evaluate the impact of ECPs on patient pathways and care in different emergency care settings.

Evaluation of triage methods used to select patients with suspected pandemic influenza for hospital admission.

Objectives: Prepandemic projections anticipated huge excess attendances and mortality in an influenza pandemic. A number of tools had been suggested for triaging patients with influenza for inpatient and critical care admission, but none had been validated in these patients. The authors aimed to evaluate three potential triage tools--CURB-65, PMEWS and the Department of Health community assessment tool (CAT)--in patients in the first waves of the 2009 H1N1 pandemic.

A randomized, controlled dose-ranging study of risedronate in children with moderate and severe osteogenesis imperfecta.

Moderate to severe osteogenesis imperfecta is associated with multiple fractures in childhood. There are no published data regarding the effects of third-generation bisphosphonates in these children. This randomized study investigated which of three different doses of risedronate was most effective in reducing fracture incidence.

Acupuncture for low back pain: traditional diagnosis and treatment of 148 patients in a clinical trial.

Aims: To assess patterns of diagnosis, including concordance, and treatment within a clinical trial of traditional acupuncture for low back pain.

Setting: In a pragmatic randomised controlled clinical trial, 148 patients with low back pain, of between 4 weeks and 12 months duration, were randomised to the offer of individualised acupuncture and received up to 10 treatments.

Methods: Standardised diagnosis and treatment records were completed by practitioners for 148 patients.

The effect of GP telephone triage on numbers seeking same-day appointments.

Telephone consultations with general practitioners (GPs) have not been shown to be an effective way to reduce the demandfor face-to face appointments during the surgery hours. This study aims to determine if GP telephone triage can effectively reduce the demandforface-to -face consultations for patients seeking same-day appointments in general practice. We report an interrupted time series, twoyears before and one year after introduction of GP-led telephone triage.