A novel advanced synthetic bioactive glass matrix was studied in patients with non-healing diabetic foot ulcers (DFUs). Bioactive glasses can be constructed to be biocompatible, with water-soluble materials in multiple geometries including fibre scaffolds that mimic the 3D architecture of a fibrin clot. In this trial, chronic, Wagner Grade 1 DFUs were randomised to receive borate-based bioactive glass Fibre Matrix (BBGFM) plus standard of care (SOC) therapy for 12 weeks or SOC alone. The primary study endpoint was the proportion of subjects that obtained complete wound closure at 12 weeks. Secondary endpoints included time to achieve complete wound closure at 12 weeks. In the modified intent-to-treat (mITT) analysis, 48% (32/67) treated with BBGFM plus SOC healed at 12 weeks compared to 24% (16/66) with SOC alone (p = 0.007). In the per protocol (PP) population, 73% (32/44) of subjects treated with BBGFM plus SOC healed versus 42% (16/38) in the SOC group (p = 0.007). Based on the success of this trial, BBGFM demonstrates faster healing of DFUs compared to SOC and should be considered in the treatment armamentarium for Wagner Grade 1 DFUs. Future trials should investigate the use of BBGFM for healing deeper chronic DFUs, other wound aetiologies, or complex surgical wounds.
Predicting medical/surgical nurses' delivery of patient pressure injury prevention education within 24 h of hospitalisation.
A cross-sectional sub-study drawn from a larger multisite randomised controlled trial.
A consecutive sub-sample of 300 randomly assigned control group participants was recruited from 20 medical and surgical wards at two major hospitals (July 2020 to August 2023) in Queensland, Australia. Semi-structured observations and chart audit data were collected, including patient education, demographic and clinical data. Binary logistic regression identified hospital site, clinical and patient predictors contributing to pressure injury prevention education delivery by nurses.
Seventeen (5.7%) participants received pressure injury prevention education within the first 24 h of admission. Body mass index was an independent predictor, increasing the odds of nurses delivering patient education.
Few episodes of pressure injury prevention education were observed in this study. As a patient's body mass index rises, they are more likely to receive preventative education from nurses soon after admission.
Our findings underscore the need for standardised inclusive protocols and ongoing nurse training to assess and address education needs beyond single risk factors like body mass index. Further research should explore other factors influencing patient education delivery in hospitals.
This study adhered to STROBE guidelines. Dr. Brett Dyer, statistician, is part of the author team.
No patient or public contribution.
Investigate the perception of male accessibility to the fields of nursing practice by those studying or teaching nursing in England.
Cross-sectional survey.
Online questionnaire with three closed-scale questions and two open-text questions designed to elicit perceptions on the accessibility of men to the fields of nursing practice. The questionnaire was distributed to the staff and students at 61 nursing schools in England. Inferential and descriptive statistics were used to analyse the closed questions data and inductive content analysis was used to analyse open-text questions data.
Students (n = 52) and staff (n = 51) responded to the survey. Adult (Mdn = 6, IQR = 2) and mental health (Mdn = 6, IQR = 2) were perceived as the most accessible fields of nursing practice to men, and child (Mdn = 4, IQR = 2) the least. Specialised practice areas in acute and emergency (Mdn = 6, IQR = 2), education (Mdn = 6, IQR = 2), leadership (Mdn = 7, IQR = 1), prison services (Mdn = 7, IQR = 1), and research (Mdn = 7, IQR = 2) were rated the most accessible to men and neonatal care (Mdn = 3, IQR = 3) the least. Societal stereotyping and stigma were seen as barriers to men entering the nursing profession. The perception that nursing is a feminised profession persists and a distrust of men is associated with child nursing. Men were viewed as progressing to leadership roles with greater ease than women.
Societal level stereotyping and stigma are perceived as prevalent in nursing practice areas considered less accessible to men entering the nursing profession.
This study adds insight into the gendered nature of nursing and highlights the barriers to men entering a profession with a workforce crisis.
STROBE cross-sectional studies guidelines. COREQ guidelines for content analysis.
No patient or public contribution.
The aim of this study was to develop a conceptual understanding of the role of caring for older adults with combined vision and hearing impairment (DSI).
Dual sensory impairment (DSI) impacts both listening and speechreading communication, function and social participation, meaning that older adults often require support and care to ‘age in place’ successfully. Family carers play a key role in supporting older adults with DSI to maintain social and physical health.
This qualitative study uses Charmaz's constructivist grounded theory (GT) methodology. Data were collected between 2017 and 2019 and analysed using constructivist GT methods. Lengthy interviews with eight family carers of older adults living with DSI explored personal histories of DSI, relationships with families, social networks and health care professionals.
This study demonstrates that caring in this context is predominantly social and ‘invisible’. To reduce the social effort of their family member with DSI and to maintain their own self-identity, family carers adopted a ‘conscious caring’ approach. This is conceptualised as an approach to caring that supports family carers to access resources embedded in their social networks by bridging the gap between the dyad and their broader, more diverse social networks.
This study identifies that a reduction in both close and broader social networks limits personal, social and psychosocial resources and impacts the capacity of the dyad to renegotiate their roles, create and maintain their individual and shared social networks and successfully transition to living with DSI.
There is a gap in the literature regarding the impact of sensory impairments on complex communication, health and social care needs of older adults and the role that family carers play. Registered nurses require complex communication skills to support older persons with DSI during health and social care interactions. A better understanding of DSI itself, as well as understanding the key role family carers play in integrating care for their family member, is crucial to delivering person-centred care.
This study addresses a growing social gerontological issue and identifies the role that family carers play in integrating health and social care for their family member with DSI. Better professional recognition of DSI and increased visibility of the challenges of living with DSI could help address barriers to effective communication between service providers, formal care support staff and those with DSI. Integrating family carers into care teams is critical to improving health and social care experiences for both caregiver and care receiver.
This study did not include patient or public involvement in its design, conduct, or reporting.
(1) Analyse in depth an exemplar safety-critical task required of newly qualified doctors (prescribing insulin) and (2) Provide transferable insights into how undergraduate education could better educate medical students to meet the demands of practice when they become postgraduate trainees.
Document analysis of doctors’ reported experiences of insulin prescribing, an everyday task that has an emergent logic of practice and harms not just patients but (psychologically) new doctors. Application of third-generation (social emergence) complexity theory to explore why practice can be ‘mutually unsafe’.
A system of care comprising all five Northern Irish (UK) Health and Social Care Trusts, which together provide healthcare to a population of nearly two million people.
68 postgraduate year 1 and year 2 trainees (PGY1/2s), mainly PGY1s.
Thick description of new doctors’ contexts of action, reasons for acting and specific actions. We present this as a narrative compiling all 68 stories, 13 detailed exemplar stories and a diagram summarising how multiple factors interacted to make practice complex.
Situations that required PGY1/2s to act had interacting layers of complexity: (1) disease trajectories; (2) social dynamics between stakeholders and (3) contextual influences on stakeholders’ interactions. Out-of-hours working and unsuitable wards intensified troublesome contextual influences. All three individually complex layers ‘crystallised’ briefly to create ‘moments of action’. At best, PGY1/2s responded proactively, ‘stretched time’ and checked the results of their actions. At worst, PGY1/2s ‘played safe’ in unsafe ways (eg, took no action), acted on unsafe advice or defaulted to actions protecting them from criticism. Informal, pervasive rules emerged from, and perpetuated, unsafe practice.
New doctors’ work includes acting on indeterminate, emergent situations whose complexity defies rules that are determinate enough to be taught off the job. If new doctors are to perform capably in moments of action, medical students need ample, supervised, situated experience of what it is like to take responsibility in such moments.
To explore the challenges experienced by people with intellectual disability, their carers and health and social care professionals when using and managing medication.
A synthesis of qualitative research using meta-ethnography.
We searched seven databases: MEDLINE, Embase, CINAHL, Science, Social Science and Conference Proceedings Citation Indices (Web of Science), Cochrane Library, PsycINFO and Proquest Dissertations and Theses from inception to September 2022 (updated in July 2023).
We included studies exploring the challenges and perceptions of people with intellectual disability, their carers and health and social care professionals regarding medication management and use.
We reviewed 7593 abstracts and 475 full texts, resulting in 45 included papers. Four major themes were identified: (1) Medication-related issues, (2) navigating autonomy and relationships, (3) knowledge and training needs and (4) inequalities in the healthcare system. We formulated a conceptual framework centred around people with intellectual disability and described the interconnectedness between them, their carers and health and social care professionals in the process of managing and using medication. We identified challenges that could be associated with the person, the medication and/or the context, along with a lack of understanding of these challenges and a lack of capability or resources to tackle them. We developed an overarching concept of ‘collective collaboration’ as a potential solution to prevent or mitigate problems related to medication use in people with intellectual disability.
The effective management of medication for people with intellectual disability requires a collaborative and holistic approach. By fostering person-centred care and shared decision-making, providing educational and practical support, and nurturing strong relationships between all partners involved to form a collective collaboration surrounding people with intellectual disability, improved medication adherence and optimised therapeutic outcomes can be achieved.
CRD42022362903.
To synthesise the existing literature on effective interventions aligned with the 2015 U.S. Occupational Safety and Health Administration guidelines to address workplace violence against nurses.
An integrative review.
PubMed, Embase, CINAH, and PsycINFO databases were searched for articles published between 2010 and 2023. Articles addressing WPV interventions and published in English were included.
Thirty-seven of 834 articles met the inclusion criteria. The review revealed several strategies to address workplace violence in healthcare settings, with staff training being the most common strategy. However, most interventions were researcher-designed, often excluding input from nurses or other stakeholders. Limited managerial support for nurses following the incidents was another prominent finding.
Although safety training programmes are common, there are critical gaps in managerial support and nurse involvement in intervention development. Further research should focus on incorporating nurse contributions and strengthening managerial support to enhance prevention efforts.
Addressing workplace violence in healthcare settings requires a comprehensive approach beyond safety training. Active nurses' participation in intervention design and enhanced managerial support are essential for creating effective solutions. Healthcare administrators should create environments that empower nurses to contribute to solutions.
This review highlights existing gaps in interventions and emphasises the need for collaborative and nurse-centered approaches to address workplace violence.
The reporting of this review was guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses.
No patient or public contribution.
Postpartum psychosis is a psychiatric emergency that occurs following childbirth. Women are often cared for in general psychiatric units or in psychiatric Mother and Baby units. Postpartum psychosis is associated with a significant risk of relapse. There is a need to explore how women perceive care to understand what works well or needs further improvement.
This review aimed to explore women's experiences of care and support for postpartum psychosis.
A systematic review using meta-ethnographic methods was conducted.
Comprehensive searches were conducted between 4 March 2024 and 4 March 2025 on five databases (CINAHL, EMBASE, MEDLINE, PsycINFO and Web of Science). Backward and forward chain searching was also undertaken.
Critical appraisal was conducted following screening. Reciprocal and refutational translation were used to form the synthesis, and a line of argument was developed. The eMERGe reporting guidelines were used.
Fifteen studies were included within this synthesis. All the studies were conducted in high income countries and included 235 women. Three main themes were developed. ‘Navigating the unknown’ explored women's perceptions of postpartum psychosis as a less well-known condition, and their informational needs. ‘The double-edged sword of care’ found that there were helpful elements of formal mental health care, but that accessing care was sometimes traumatic, stigmatising and conflicting to women's identities. ‘Seeking consolation and recovery’ explored women's need for psychological support and experiences of peer support.
The findings of this review highlighted women's needs in respect to informational support, medication support, psychological support and in-patient care settings. Mother and baby units were strongly preferred by women.
The findings highlighted a need for specialised care for postpartum psychosis.
There were no patient or public contributions.
Prospero (CRD42024515712)
To explore the experiences of significant others of patients with severe burn injury in the intensive care unit. Specifically, how severe burn injury impacted the significant other and their role within their loved one's life.
This qualitative study employed a Narrative Inquiry approach.
Interviews were undertaken during 2021–2022 with 17 participants who were the significant others of a patient with severe burn injury in the Intensive Care Unit. Recruitment occurred in New South Wales, Australia, from two tertiary hospitals providing care for people with major burns. A narrative inquiry approach was utilised, capturing stories through semi-structured interviews.
Significant others experienced necessary changes in their life in response to the catastrophe. These included advocating, being present and ensuring their loved one's needs were met, while often neglecting themselves. Significant others contemplated their future as a carer to their loved one with severe burn injury, and adjusting their own career, finances and lifestyle, often as a long-term measure. The shifting of their role to carer ultimately transformed and redefined their relationships and lives.
Significant others endure immense trauma when a loved one sustains a severe burn injury. They require support but prioritise the patient by virtue of their critical illness. The life of the significant other is changed as they take on the role of carer and provide support. It is, therefore, imperative that the support needs of significant others are recognised, understood and addressed to ensure their well-being while processing the trauma.
With increased understanding of the significant others' experiences, healthcare providers can adopt a consultative approach, where roles and boundaries can be clearly identified. Through this process, healthcare providers can strengthen rapport and provide targeted support for significant others, as they navigate this traumatic life-altering event.
No patient or public contribution.
To describe patient outcomes for patients at high risk of mortality (with a prognosis of three months or less to live) where a Palliative Care Nurse Consultant (PCNC) was embedded in a General Medicine team. To explore patients and/or their carers feedback and allied health, nursing professionals' perspectives on integrating a palliative care approach in the General Medicine ward.
Prospective exploratory study.
SQUIRE reporting guidelines was adopted for the study reporting. This study was conducted over six weeks in a general medicine ward at Monash Medical Centre in Melbourne, Australia. Participants were 20 patients aged > 65 years with non-malignant, chronic conditions at high risk of mortality within three months and had 18 nursing and allied health professionals involved in their care. Quantitative data were analysed descriptively and qualitative survey data were analysed thematically.
Twenty patients participated, with an average age of 87 years. 55% spoke a language other than English. PCNC interventions, focused on care coordination and family liaison, were found to facilitate timely referrals to other support services, improve communication and better address end-of-life care needs. Healthcare professionals recognised the benefits of PCNC involvement; however, a key qualitative theme was staff reluctance to raise palliative care needs due to perceived role boundaries and limited confidence. While PCNC presence improved communication and advocacy, barriers included time constraints and patient/family resistance.
Embedding a PCNC in a general medicine team appears to enhance care coordination and support timely palliative care integration. Addressing barriers and optimising workflow can improve patient, carer and clinician experience as well as improve resource utilisation.
The model has the potential to enhance patient-centred care and clinician support in acute general medicine settings.
The research will have an impact on acute care settings, particularly general medicine units, by informing models of integrated palliative care for patients with complex needs and enhancing staff capability and confidence in providing timely, person-centred care.
Patients or members of the public were not involved in the design, conduct, analysis or manuscript preparation of this study. The project was a prospective observational study with limited scope and resources, which did not include a formal patient or public involvement component.
To develop and psychometrically test a comprehensive Cancer Nurse Self-Assessment Tool (CaN-SAT).
Modified Delphi to assess content validity and cross-sectional survey to assess reliability and validity.
Phase 1: An expert group developed the tool structure and item content. Phase 2: Through a modified Delphi, cancer nursing experts rated the importance of each element of practice and assessed the relevance and clarity of each item. Content Validation Indexes (CVI) were calculated, and a CVI of ≥ 0.78 was required for items to be included. Phase 3: Cancer nurses participated in a survey to test internal consistency (using Cronbach's alpha coefficients) and known-group validity (through Mann–Whitney U tests). This study was reported using the Guidelines for Reporting Reliability and Agreement Studies (GRRAS) checklist.
The CaN-SAT underwent two rounds of Delphi with 24 then 15 cancer nursing experts. All elements of practice were rated as important. Only three items achieved a CVI < 0.78 after round one; however, based on open-ended comments, 26 items were revised and one new item added. After round two, all items received a CVI above 0.78. The final tool consisted of 93 items across 15 elements of practice. Cronbach's alpha coefficients were between 0.92 and 0.98 indicating good reliability. Mann–Whitney U tests demonstrated significant differences between clinical nurses and advanced practice nurses across 13 out of 15 elements of practice.
The CaN-SAT is a comprehensive, valid and reliable tool that can be used for cancer nurses to self-assess current skill levels, identify their learning needs and inform decisions about educational opportunities to optimise cancer care provision.
The research team included three patient advocates from Cancer Voices NSW, who were actively involved in all aspects of the study and are listed as authors.
Preterm infants, particularly those born before 29 weeks of gestation, are at increased risk of developing bronchopulmonary dysplasia (BPD) and other complications of prematurity. Substantial evidence suggests that respiratory tract colonisation with Ureaplasma species significantly contributes to pulmonary inflammation, impaired lung function and subsequent lung disease especially in very immature infants. Moreover, Ureaplasma exposure has been implicated in the pathogenesis of other inflammation-related sequelae of prematurity. Although representing a potentially actionable risk factor for adverse short-term and long-term neonatal outcome, controversies on Ureaplasma-associated morbidity remain and recommendations for screening practices in preterm infants are missing. The NEO-CONSCIOUS (Neonatal Colonisation and Infection with Ureaplasma in very immature preterm infants born Ureaplasma colonisation and infection in very preterm infants at high risk of adverse outcome, the extent of potentially accompanying inflammation and the impact on short-term and long-term morbidity.
This is a prospective observational multicentre study being conducted in level III neonatal intensive care units in Germany and Austria. In total, 400 infants born before 29 weeks of gestation are screened for Ureaplasma colonisation immediately after birth. In addition, biomarkers of systemic inflammation are determined on day 1 and day 28. The study infants are followed up until discharge and at 2 years corrected age. The primary outcome BPD and/or death is assessed at 36 weeks postmenstrual age. Secondary outcomes include systemic inflammation, secondary infections, intraventricular haemorrhage, periventricular leukomalacia, necrotising enterocolitis, retinopathy of prematurity and neurodevelopmental outcome at 24 months corrected age.
The study has been approved by the ethics committees in Würzburg and Leipzig and the local ethics committees of all participating centres. Results will be disseminated through peer-reviewed international publications and conferences. The study is registered with the German Clinical Trials Register, ID DRKS00033001.
German Clinical Trials Register (DRKS00033001).
To determine whether the I-DECIDED assessment and decision tool enhances peripheral intravenous catheter assessment, care and decision-making in paediatrics.
Quasi-experimental, interrupted time-series study.
An interrupted time-series study was conducted in a paediatric inpatient unit at a public teaching hospital in Brazil. The participants were patients aged less than 15 years old with a peripheral intravenous catheter, and their parents or guardians. Data were collected between January and July 2023, encompassing six time points, three pre-intervention and three post-intervention. Evaluation data were based on the I-DECIDED tool, including idle devices, dressings, complications, patient/family awareness, hand hygiene, disinfection and documentation.
We conducted 585 peripheral intravenous catheter observations, with 289 in the pre-intervention phase and 296 in the post-intervention phase, inserted in 65 hospitalised children, 30 in the pre-intervention phase and 35 in the post-intervention phase. After the intervention, reductions were observed in the number of idle catheters, substandard dressings and complications. Patients and family members reported an increase in device assessment, hand hygiene and peripheral intravenous catheter disinfection. Additionally, there was an increase in documentation of decision-making performed by nurses and nursing technicians/assistants.
Implementation of the I-DECIDED assessment and decision tool in a paediatric unit significantly improved the assessment, care and decision-making regarding peripheral intravenous catheters.
Opportunity to enhance practice standards, elevate the quality of care provided to paediatric patients, contribute to improved patient outcomes, advance evidence-based practice in vascular access management and enhance patient experience through increased involvement in care.
To influence clinical practice and healthcare policies aimed at improving peripheral intravenous catheter care and patient safety in paediatric settings.
No patient or public contribution to the design of this study.
This study aims to investigate the associations between childhood health, childhood socioeconomic status and dementia risk in later life, and to assess the potential modifying effects of their interaction. The study also accounted for key confounders to better clarify these relationships within the Indonesian population.
Cross-sectional study.
Indonesia.
6693 aged 50+.
Individuals in the ‘unhealthy’ childhood health cluster had 1.17 times higher odds of dementia risk compared with the ‘healthy’ cluster (95% CI: 1.00 to 1.38), a borderline association, while those in the ‘poor socioeconomic status’ cluster had 1.39 times higher odds compared with the ‘non-poor’ cluster (95% CI: 1.15 to 1.68). No significant interaction was found between childhood health and socioeconomic status on either the multiplicative (OR=0.88, 95% CI: 0.30 to 2.57) or additive scale (all relative excess risk due to interaction, attributable proportion and synergy index measures non-significant). Older age, lower education, lower wealth, lower social capital and higher depression scores are significantly associated with increased dementia risk.
This study finds that both childhood health and socioeconomic status independently influence dementia risk in later life. No significant interaction between these two early-life factors was found, suggesting that their effects on dementia risk operate independently rather than synergistically. Using nationally representative Indonesian data, the findings highlight the importance of addressing early-life adversity in dementia prevention and call for standardised definitions to improve research comparability, particularly in low-income and middle-income countries contexts.
Signs of clinical deterioration may appear differently in children with dark-coloured skin. How to assess children in this cohort is currently poorly defined.
To explore available information on the assessment of clinical deterioration in children with dark-coloured skin and identify research deficits.
A scoping review following Arksey and O'Malley and PRISMA-ScR frameworks. Five online databases, grey literature and reference lists of eligible documents were searched. Source titles, abstracts and full texts were screened. Included documents were assessed for level of evidence according to the Joanna Briggs Institute. Data were charted on a pre-defined data collection tool and analysed through descriptive and content analysis.
Out of 2382 documents screened, 37 were included. Document types included 16 quantitative studies, 14 opinion papers, five reviews and two reports. Most sources (21) were low-level evidence. Sixty-six unique terms were used to describe dark-coloured skin. Eighteen documents reported use of a skin classification system, including race/ethnicity, established colour scales, cosmetic references and observer opinion. Twelve focused on newborn hyperbilirubinaemia. Considerations for assessing jaundice, pallor, cyanosis, pulse oximetry, petechiae and signs of shock were reported. Techniques to improve assessment included optimising the environment, identifying baseline skin colour, and involving families and patients in assessment. No documents reported on assessment of mottling or capillary refill time for children with dark-coloured skin.
Assessment of clinical deterioration for children with dark-coloured skin is highly relevant to health professional practice. There is an overall deficit in high-quality research. Specific information gaps in assessment are considerations for mottling, capillary refill time, APGAR scoring, and clinical implications of device overestimation of bilirubin and oxygen saturations in children with dark-coloured skin. Health professionals are encouraged to use devices cautiously. Greater accuracy and objectivity are necessary to fill these gaps and support effective detection of signs of clinical deterioration.
Post-intensive care syndrome (PICS) describes a cluster of ongoing symptoms experienced by a large proportion of patients previously admitted to critical care. Despite a large rise in survival following critical care, interventions to support recovery and combat PICS are lacking. It has been suggested that the use of digital tools such as virtual reality (VR) may play a useful role in the development of recovery-supporting interventions. We engaged with people with lived experience of critical care admission to coproduce a VR intervention (ViRtual REality to AiD recoverY post ICU (VR READY)). Here, we present a protocol for the initial feasibility and acceptability testing of this intervention.
This is a single-arm, single-site, non-randomised feasibility trial of VR READY. Up to 25 participants recently admitted to critical care will be recruited to use the VR READY intervention for at least 5 min per day for a period of 14 days. Participants must have capacity to consent and be free from ongoing delirium in order to participate. Outcomes relating to sleep and well-being will be measured at baseline and at day 14 after intervention delivery. The primary outcome is feasibility, which will be assessed according to prespecified criteria. Participants will complete a qualitative interview to assess acceptability of the intervention, trial design and outcomes approximately 1 month after completing the intervention period. No formal statistical analysis of outcomes will be conducted, but these will be summarised descriptively. Interviews will be subjected to reflexive thematic analysis.
This study received a favourable ethical opinion by North-East York Research Ethics Committee (Ref 23/NE/0113) in June 2024. Study results will be disseminated through the peer review literature, ISRCTN registry and directly to participants, which will be facilitated by the study public and patient involvement steering group.
Rare diseases (RD) are collectively common and often genetic. Families value and can benefit from precise molecular diagnoses. Prolonged diagnostic odysseys exacerbate the burden of RD on patients, families and the healthcare system. Genome sequencing (GS) is a near-comprehensive test for genetic RD, but existing care models—where consultation with a medical geneticist is a prerequisite for testing—predate GS and may limit access or delay diagnosis. Evidence is needed to guide the optimal positioning of GS in care pathways. While initiating GS prior to geneticist consultation has been trialled in acute care settings, there are no data to inform the utility of this approach in outpatient care, where most patients with RD seek genetics services. We aim to evaluate the diagnostic yield, time to diagnosis, clinical and personal utility and incremental cost-effectiveness of GS initiated at the time of referral triage (pre-geneticist evaluation) compared with standard of care.
200 paediatric patients referred to one of two large genetics centres in Ontario, Canada, for suspected genetic RD will be randomised into a 1:1 ratio to the intervention (GS first) or standard of care (geneticist first) arm. An unblinded, permuted block randomisation design will be used, stratified within each recruitment site by phenotype and prior genetic testing. The primary outcome measure is time to genetic diagnosis or to cessation of active follow-up. Survival analysis will be used to analyse time-to-event data. Additional measures will include patient-reported and family-reported measures of satisfaction, understanding and perceived test utility, clinician-reported measures of perceived test utility and management impact, and healthcare system utilisation and costs.
This study was approved by Clinical Trials Ontario. Results will be disseminated, at minimum, via peer-reviewed journals, professional conferences and internal reports to funding bodies. Efforts will be made to share aggregated study results with participants and their families.
by Vijeeth Guggilla, Jennifer A. Pacheco, Alexandre M. Carvalho, Grant R. Whitmer, Anna E. Pawlowski, Jodi L. Johnson, Catherine A. Gao, Chad J. Achenbach, Theresa L. Walunas
BackgroundAdults with immunosuppression are more likely to develop severe COVID-19 than adults without immunosuppression. Less is known about differences in outcomes for adults with immunosuppression who are hospitalized with COVID-19.
MethodsA retrospective cohort study of adults hospitalized with COVID-19 at Northwestern Medicine hospitals between 03/01/2020 and 05/31/2022 was performed. Regression analyses were performed comparing in-hospital mortality, intensive care unit (ICU) admission, oxygenation requirements, and hospital/ICU length of stay among patients without immunosuppression (n = 9079) and patients with immunosuppression (n = 873).
ResultsPatients with immunosuppression had significantly higher mortality than patients without immunosuppression (OR: 1.33, 95% CI: 1.11–1.60). This effect was even stronger when controlling for age at admission, diabetes, obesity, SARS-CoV-2 variant era, and COVID-19 medication use (adjusted OR: 1.78, 95% CI: 1.46–2.16). ICU admission (adjusted OR: 1.64, 95% CI: 1.41–1.90) and invasive ventilation (adjusted OR: 1.68, 95% CI: 1.36–2.06) were also significantly higher in patients with immunosuppression. Hospitalization length (median: 7 days) and ICU length of stay (median: 2.5 days) were longer in patients with immunosuppression compared to patients without immunosuppression (median: 5 days, adjusted p Conclusions
Patients with immunosuppression had worse outcomes than patients without immunosuppression. Subgroup analyses showed that patients with solid organ transplant had the worst outcomes overall. Patients with HIV had similar outcomes as patients without immunosuppression unless CD4 cell count was low.
The enhanced midwifery continuity of carer (eMCoC) pilot programme provided additional resource (funding) to midwifery teams operating in the 10% most deprived areas in England. The eMCoC programme aims to provide additional support to those at greatest risk of poor maternal health outcomes. We conducted a rapid formative evaluation aiming to explore the implementation of the pilot programme to (1) generate timely insights to inform ongoing service delivery; (2) generate a logical framework of the eMCoC service and; (3) inform the design of a longer-term summative evaluation.
Rapid evaluation using mixed-methods.
We explored implementation of the eMCoC service in 58 funded local midwifery teams across 23 Local Maternity and Neonatal Systems (LMNS). We undertook qualitative data collection in 10 case study sites across England, focusing on the implementation in 17 teams.
We purposively sampled 34 service users who received care from enhanced teams, and 38 staff working in enhanced teams. Inclusion criteria for the service user interviews included women who had received care from enhanced teams during our evaluation period and were more than 28 weeks pregnant. Exclusion criteria included women who had not received care from our target teams. We undertook descriptive analysis using the Maternity Services Dataset to compare the characteristics of service users in enhanced teams with service users receiving other midwifery service models.
Many of the 58 teams funded were unable to implement eMCoC during the evaluation period because of institutional and organisational barriers. The barriers identified here are indicative of the barriers associated with implementing midwifery continuity of carer. Largely, the eMCoC service successfully targeted women living in the most deprived areas and a focus on reaching women living in these areas was valued by enhanced teams. Equally, enhanced teams strived to broaden the targeted characteristics (i.e. more broadly than on the basis of deprivation) to include a wider and more diverse set of social risk factors and vulnerabilities, based on local needs and priorities. Service users reported being well supported by the enhanced teams, including receiving relational and well-being support and personalised one-to-one public health education, information and support. Service users emphasised that enhanced teams went ‘above and beyond in their care’.
Funding for eMCoC has been well received by both staff and service users. The implementation of the enhanced roles was perceived to have supported delivery of team-based care, facilitating successful release of midwifery capacity and the delivery of additional public health activities. Supporting a team-focused ethos seems an important feature of eMCoC services. This was consistent across sites and from both staff and service user perspectives. There appears to be many routes (i.e. different service delivery types) to delivering enhanced care, and the multiplicity of service delivery types found in this evaluation suggests no tightly prescribed way of meeting eMCoC’s objectives. The flexibility of the initial funding specification guidance from NHS England has been a key driver of local ownership and permitted eMCoC services to be organically built ‘from the ground up’. Our conclusions point to the value of autonomy afforded to local areas to use eMCoC funding as they deem necessary to best suit the needs of their staff and specific service user groups. Attention should be placed on the barriers to implementation and sustainability issues which can be addressed, namely: delays in releasing funding from LMNS and Integrated Care Boards to providers, and protecting maternity support worker and midwifery time to their allocated teams.