First post-contrAst SubtracTed (FAST) MRI, an abbreviated breast MRI scan, has high sensitivity for sub-centimetre aggressive breast cancer and short acquisition and interpretation times. These attributes promise effective supplemental screening. Until now, FAST MRI research has focused on women above population-risk of breast cancer (high mammographic density or personal history). DYAMOND aims to define the population within the population-risk NHS Breast Screening Programme (NHSBSP) likely to benefit from FAST MRI. The study population is the 40% of screening clients aged 50–52 who have average mammographic density (BI-RADS (Breast Imaging Reporting and Data System) B) on their first screening mammogram. DYAMOND will answer whether sufficient numbers of breast cancers, missed by mammography, can be detected by FAST MRI to justify the inclusion of this group in a future randomised controlled trial.
Prospective, multicentre, diagnostic yield, single-arm study with an embedded qualitative sub-study: all recruited participants undergo a FAST MRI. An internal pilot will assess the willingness of sites and screening clients to participate in the study. Screening clients aged 50–52, with a clear first NHSBSP mammogram and BI-RADS B mammographic density (by automated measurement) will be invited to participate (recruitment target: 1000). The primary outcome is the number of additional cancers detected by FAST MRI (missed by screening mammography). A Fleming’s two-stage design will be used as this allows for early stopping after stage 1, to save participants, funding costs and time continuing to the end of the study if the question can be answered earlier.
The NHSBSP Research and Innovation Development Advisory Committee and the Yorkshire and Humber–Sheffield Research Ethics Committee (23/YH/0268, study ID (IRAS): 330059) approved this research protocol. Participation involves a two-stage informed consent process, enabling screening for eligibility through automated mammographic density measurement. Patients with breast cancer helped shape the study design and co-produced participant-facing documents. They will disseminate the results to the public in a clear and meaningful way. Results will be published with open access in international peer-reviewed scientific journals.
The Validating Outcomes by Including Consumer Experience (VOICE) project is developing patient reported experience measure (PREM) tools to collect consumer feedback for Indigenous primary healthcare (IPHC) services’ accreditation and quality improvement processes. This study aimed to explore the views of health service staff about: (1) optimising the feasibility of collection, analysis and interpretation of findings; and (2) resourcing requirements for implementation of the PREM.
A participatory action research qualitative study design, guided by an Indigenous advisory group. Our team of Indigenous and non-Indigenous researchers conducted semistructured focus groups and individual interviews with IPHC staff. Focus groups and interviews were recorded, transcribed and thematically analysed. Multiple sense-making meetings were conducted with the Indigenous advisory group.
Eight partner IPHC services across four Australian states and territories.
All staff were eligible and invited to participate in the study via purposive and snowball sampling. Administrative staff (eg, receptionist, programme facilitator), clinicians/practitioners (eg, general practitioner, nurse, Aboriginal and Torres Strait Islander health workers and practitioners) and service managers (eg, CEO, practice manager) from partner health services participated.
63 staff participated; 44 attended across 13 focus groups, with the remainder participating in individual interviews. The majority of participants were between 35 years and 55 years old (52%), female (66%) and working in frontline IPHC service delivery roles (56%). Equal numbers identified as Indigenous (50%) and non-Indigenous (50%). Many had worked in the Indigenous health and well-being sector for over 10 years (40%). ‘Culturally safe care’ and ‘accountability’ were identified as primary themes and key reasons for gathering consumer feedback. Subthemes identified were ‘Relationships’, ‘trust and respect’, ‘communication about consumer feedback’, ‘timing and frequency of requesting consumer feedback’, ‘health service systems’, ‘health service and staff capacity’, ‘staff skills’ and ‘structure and administration of the PREM’. All themes and subthemes need to be considered for the successful design and implementation of PREMs in IPHC settings.
Many of the issues identified are not currently considered in the process of collecting PREM data for accreditation yet, if addressed, would likely improve the quality and relevance of data collected. The findings from this study will inform the co-design and validation of Indigenous-specific PREM tools to collect consumer feedback. Critically, service and community input will ensure the PREM tools meet service needs for continuous quality improvement and accreditation and reflect the priorities and values of Indigenous peoples.
Pre-eclampsia (PEC) is a morbid and potentially lethal complication of pregnancy and is more common in women with risk factors such as hypertension, diabetes, autoimmune disease, kidney disease or multifetal pregnancies. Low dose aspirin (ASA) is currently the only prophylactic therapy known to decrease PEC in this patient population. However, currently, there is no prospective literature comparing various low-dose ASA formulations in the risk reduction of PEC. In the USA, the currently available low-dose ASA is over-the-counter and found in 81 mg tablets. Therefore, when clinicians initiate low-dose ASA therapy, they may prescribe one or two tablets of 81 mg per day without comparative evidence to guide their decision. Our objective is to prospectively compare pregnant patients on 81 mg vs 162 mg of ASA and determine a possible dose response in the prevention of PEC.
We designed a pragmatic phase 3 prospective randomised open label blinded-end point clinical trial with parallel assignment between two groups of pregnant people at high risk for PEC, as defined by the US Preventive Services Task Force and American College of Obstetricians and Gynecologists (ACOG). The primary outcome is the incidence of preterm (
Our research protocol and safety monitoring protocol have been approved by the Weill Cornell Medicine institutional review board (IRB) and the Office of Human Research Protection. Evaluation for adverse events will be monitored throughout the study period. Adverse events will be assessed at each study visit.
Patients undergoing revision total knee replacement (RevKR) surgery often have difficulties mobilising and increasingly rely on family support. Evolving practice in England aims to manage these patients in specialised centres with the intention of improving outcomes. This practice will result in longer travel distances and times in this frailer group of patients. We want to examine the types of distances and travel times patients can be expected to travel for this complex orthopaedic surgery and to explore concerns of how these impact patient outcomes.
Retrospective observational study from the Hospital Episode Statistics. Multivariable adjusted logistic regression models were used to investigate the relationship between patient travel distances and times with perioperative outcomes.
Patients presenting to tertiary referral centres between 1 January 2016 and 31 December 2019. A tertiary referral centre was defined as a trust performing >49 revisions in the year prior.
Adult patients undergoing RevKR procedures for any reason between 1 January 2016 ando 31 December 2019.
The shortest patient level travel distance and time was calculated using the Department of Health Journey Time Statistics using Transport Accessibility and Connectivity Calculator software and Dijkstra’s algorithm.
The primary outcome is emergency readmission within 30 days. Secondary outcomes are mortality within 90 days and length of inpatient stay.
6880 patients underwent RevKR at 36 tertiary referral centres. There was a weak correlation between social deprivation and travel distance, with patients from the most deprived areas travelling longer distances. Overall, 30-day readmission was not statistically associated with longer driving distance (OR 1.00 95% CI 0.99 to 1.02) or peak driving times (OR 1.00 95% CI 0.99 to 1.01).
There was no association between increasing travel distance and time on perioperative outcomes for RevKR patients.
The 2021 Pacific Northwest heat dome was Washington state’s deadliest recorded weather event and presented unprecedented response challenges to the state’s health sector. Understanding the impacts of this extreme heat event (EHE) on the sector as well as the barriers to and facilitators of implementing effective heat response is critical to preparing for future events, which are happening more frequently in the region due to climate change.
Guided by an implementation science framework, we convened listening sessions and focus groups of the health sector in western Washington to reflect on regional response efforts.
Health sector organisations in 15 counties in western Washington State, USA: Clallam, Grays Harbor, Island, Jefferson, King, Kitsap, Lewis, Mason, Pacific, Pierce, San Juan, Skagit, Snohomish, Thurston and Whatcom.
A convenience sample of 109 listening group participants was recruited through the professional networks of the Northwest Healthcare Response Network, a regional healthcare coalition. 27 of the health sector professionals were recruited using purposive sampling to participate in seven focus groups organised by organisation type.
The co-presence of the COVID-19 pandemic, limited staff capacity, resource acquisition challenges and inadequate regional collaboration emerged as key barriers, while advanced planning, indoor cooling capabilities, adapting strategies to local needs, robust internal relationships and strong external partnerships were reported to facilitate effective response. Establishing centralised coordination ahead of heat events, making improvements to the cooling capabilities of the built environment, developing plans and policies for EHEs that have co-benefits for other events, adopting evidence-informed response strategies, institutionalising the knowledge and relationships developed through prior events and improving evaluative processes (such as developing real-time monitoring capacity) will enable more effective response to future EHEs.
Western Washington’s health sector implemented EHE response activities that enabled essential service continuity, despite limited resources, unfamiliarity with EHEs and other systemic challenges. The recency of the heat dome presents an opportunity to incorporate lessons learnt into practice, policies, plans and built environment; these are necessary improvements ahead of future large-scale events the region may experience in the coming decades.
To evaluate the incidence of skin-related complications attributable to incontinence-associated dermatitis (IAD) using an external female urinary catheter device strategy for urinary incontinent (UI) patients in acute care.
Multicenter quality improvement study.
Randomized allocation of two commercially available external female urinary catheter devices was used in hospitalized UI female patients. Daily nursing skin assessments were documented in the electronic health record before, during and after external catheter device application. Methods and results were reported following SQUIRE guidelines.
Three hundred and eighty-one patients from 57 inpatient care units were included in the analysis. Both catheter devices were associated with an overall low risk (5 %) of new or worsening skin breakdown.
The overall benefit of external catheters is most persuasive for skin integrity, rather than infection prevention.
Significant negative outcomes are associated with UI patients. External female urinary catheters are a non-invasive alternative strategy to reduce exposure of regional skin to urine contamination and IAD-related skin complications. Use of external female urinary catheters in hospitalized UI female patients offers low risk (5%) of new or worsening overall skin breakdown.
Hospitalized UI female patients were screened for external catheter device eligibility by the bedside nurse. The quality improvement review committee waved consent because the intervention was considered standard care.