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Scar outcomes are known to vary by skin tone and race, yet few studies have systematically evaluated these differences using validated tools. To evaluate differences in scar maturation across Fitzpatrick skin types and racial groups from 3 to 12 months postoperatively using the modified Patient and Observer Scar Assessment Scale (POSAS) scale. We conducted a prospective observational study of 40 patients undergoing breast surgery at a single academic centre. All scars were assessed at 3 and 12 months postoperatively using the modified POSAS. Fitzpatrick skin types were categorized into I–II, III–IV, and V–VI, and racial groups included Caucasian, Black, and Hispanic patients. Fitzpatrick Types I–II had the greatest vascularity reduction (–2.06 ± 2.10), while Types V–VI showed the least improvement (–0.80 ± 1.61). Pigmentation increased in Types V–VI (+0.35 ± 1.89) and improved in lighter skin tones. Black and Hispanic patients had significantly lower odds of favourable pigmentation outcomes (p < 0.07). Fitzpatrick Types V–VI also had lower odds of improved scar relief (OR = 0.125, p = 0.034). This study highlights differences in scar maturation across skin tone and racial categories using a standardized scale. These trends underscore the importance of tailoring postoperative scar counselling and interventions to individual patients’ skin types and racial backgrounds.
by Anaïs Cheneau, Jonathan Sicsic, Thomas Rapp
As populations age, long-term care policies must balance individual preferences with financial constraints. The prevailing “aging in place” policy in France assumes that citizens overwhelmingly prefer home care over nursing homes. However, little is known about people’s preferences towards long-term care options before disability occurs. We elicit preferences among community-dwelling adults over 60 using a mixed-method approach: qualitative interviews and a two-stage D-efficient discrete choice experiment. In each task, respondents chose between two hypothetical nursing homes varying in professional care quality, living environment, out-of-pocket (OOP) cost, and proximity, then decided whether to receive care in this nursing home or remain at home. A sample of 2,886 French adults over 60 completed the survey in 2024. We used random-effect conditional logit and latent class logit models to investigate trade-offs and preference heterogeneity. While a majority (54%) consistently favored home-care, 37% shifted their decision in response to improved nursing home characteristics. Professional care quality and living environment influenced choices as strongly as OOP cost, while proximity plays a secondary role. Strengthening staffing and training, upgrading equipment and the conviviality of shared spaces, and containing OOP costs are direct levers to raise the acceptability of nursing home care.To explore the experiences and support needs of Black Canadian parents with preterm infants and to engage them in co-creating a culturally informed framework to inform nurses, healthcare providers and community organisations to better serve this population.
Preterm birth (PTB) is a traumatic experience that places significant physical and emotional strain on families and other caregivers. Despite research showing that Black mothers are at risk of PTB, little is known about their experiences of giving birth to a preterm infant and the challenges they encounter caring for these children in Canada. This lack of research specifically on Black parents in Canada makes it difficult to identify their psychosocial needs and develop intervention programmes to address their unique challenges.
A two-phase qualitative exploratory design informed by a community engagement lens will be used.
In Phase 1, five focus groups (n = 48) and 6–8 in depth interviews will be conducted with Black parents of preterm infants. Questions will explore experiences in the NICU, transition home, access to support, coping strategies and mental well-being. One focus group will be conducted with the parent advisory council of the Canadian Premature Babies Foundation, our community partner to explore gaps in services. The data from Phase 1 will be analysed and findings will be used to informed Phase 2 concept mapping exercise. This research was approved by the Toronto Metropolitan University Research Ethics Board.
There is a paucity of research addressing the experiences and needs of Black parents with preterm infants. Thus, this study is well positioned to generate the much-needed Canadian empirical knowledge on the unique experiences and stressors face by Black parents with preterm infants and inform the design of programmes and services to better support them.
This study is in collaboration with the Canadian Premature Babies Foundation, our community partner.
To explore the prescribing practices and behaviours of Advanced Practice Nurses (APN) and pharmacist prescribers in Singapore, assess their confidence in key prescribing competencies, examine their use of information sources, and understand their views on the consequences of prescribing errors.
Cross-sectional national survey.
A census survey of all registered APN and pharmacist prescribers in Singapore was conducted from February to May 2024 using a validated 96-item instrument. The survey assessed prescribing practices, confidence in prescribing competencies, use of information sources, and prescribing safety. Descriptive statistics were used for analysis.
Ninety-one prescribers (54 APNs, 37 pharmacists) responded (32% response rate), most of whom worked in public medical/surgical settings. Prescribing comprised a median of 75% of their practice. Most time was spent prescribing continued medications, with less on initiating new medicines. Participants reported high confidence in communication, therapeutic partnerships, and working within professional standards. Greatest confidence was seen in educating patients, legal prescribing, and monitoring treatment response. Lower confidence was noted in complementary medicine-related tasks. Professional literature and colleagues were the most valued information sources. Most participants acknowledged the serious consequences of prescribing errors, though many believed such errors would likely be intercepted.
APNs and pharmacists demonstrate strong competencies in safe, holistic prescribing. However, cultural factors may limit patient engagement, highlighting the need to strengthen shared decision-making and collaborative practice.
Refining governance structures, adopting tiered prescriber autonomy, and enhancing training in complex prescribing are essential. Standardising deprescribing, improving access to decision-support tools, and promoting interprofessional collaboration and patient involvement can strengthen care quality and team-based delivery.
This study offers the first national insight into Singapore's Collaborative Prescribing Framework and informs training, policy, and workforce development for non-physician prescribers locally and in similar international contexts.
STROBE checklist.
This study did not include patient or public involvement in its design, conduct, or reporting.
To explore patient and clinician experiences of participation in the MACRO randomised controlled trial (RCT)—which found endoscopic sinus surgery (ESS) to be clinically effective whereas clarithromycin was no better than placebo for chronic rhinosinusitis (CRS)—and to identify barriers and facilitators to the implementation of the trial results.
Qualitative study embedded within the multicentre MACRO RCT. Semistructured interviews with patients and clinicians were analysed using thematic analysis.
21 secondary and tertiary ear, nose and throat centres in England and Scotland participating in the MACRO RCT.
20 CRS patients (16 with nasal polyps, 4 without) were interviewed approximately 6 months after trial completion, and 17 clinical staff including principal investigators (PIs), associate PIs and research nurses.
This study explored patients’ and clinicians’ experiences of the trial to identify barriers and facilitators to implementing the findings. Adopting the outcomes of the trial would involve recommending surgery to more patients with CRS. Yet patient and clinician interviews highlighted polarised views on ESS among patients, between those with positive experiences and expectations of ESS and those expressing fear of complications and hesitancy to receive surgery. During the trial, many participants randomised to surgery reported rapid improvement in symptoms, but with postoperative challenges for some patients including pain, unexpected symptoms and variations in recovery period. Priorities for implementation include providing patients with information about risks and support to make informed choices. Clinicians also reflected on the resource implications for offering ESS to more patients.
ESS is effective for CRS, but patient hesitancy and recovery concerns persist. Implementation requires clear communication, recognition and respect for individual preferences, tailored support for decision-making and post-surgical care to optimise acceptance and outcomes.
A significant proportion of infants born at ≤29+6 weeks’ gestation develop lung disease during the neonatal period, thus putting them at risk of developing prematurity-associated lung disease in childhood and adulthood. After discharge from the neonatal unit, pre-existing lung disease in preterm-born infants is exacerbated by (often frequent) respiratory viral infections requiring greater health utilisation, including hospital admissions, than their term-born equivalents. Opportunities to prevent viral infections in infancy are largely limited to anti-respiratory syncytial virus (RSV) antibody prophylaxis and recently maternal RSV immunisation, but in term-born infants, trained immunity-based vaccines such as Bactek (MV130, Inmunotek, Spain) are increasingly used. Bactek provides a promising therapeutic avenue for preterm-born infants to target postdischarge respiratory viral infection in this vulnerable group of infants. The BALLOON study aims to assess this treatment in a very/extremely preterm-born population and determine if treatment with the trained immunity-based vaccine Bactek decreases the risk of unscheduled visits to healthcare professionals for lower respiratory tract infections, when compared with placebo. Included infants are born at ≤29+6 weeks’ gestation and treated daily from term-equivalent (37–43 weeks’ postmenstrual age, PMA) or from discharge, if earlier, up to 1 year of corrected age.
542 infants are being recruited prior to discharge by neonatal units in the UK. They are being randomised to receive Bactek or placebo, once daily dose of 2 sprays (each 0.1 mL) of IMP (300 Formazin Turbidity Units), from 37 to 43 weeks’ PMA or discharge if earlier up to 1 year of corrected age. The primary objective is to assess if sublingual Bactek spray decreases the risk of health professional diagnosed lower respiratory tract infections (LRTIs) (unscheduled visits to general practitioners, accident and emergency departments and hospital admissions) between enrolment and 1 year of corrected age. Secondary outcomes include the number of parent-reported, health professional-confirmed unscheduled visits for LRTIs, the time to first parent-reported, health professional-confirmed unscheduled visit for LRTI, parent-reported wheeze episodes (identification aided by WheezeScan (Omron, Japan)), parent-reported use of respiratory medications, growth (weight, length and head circumference), parent(s)/guardian(s) reported time missed from work and/or nursery time missed for the infant and volume of adverse reactions. Viruses associated with LRTIs will also be identified.
Ethics permission has been granted by the Wales Research Ethics Committee 3 (Ref 24/WA/0181), and regulatory permission by the Medicines and Healthcare Products Regulatory Agency (CTA reference 21323/0063/001-0004). The study is registered on ISRCTN (ISRCTN14019493). Findings will be disseminated via national and international peer-reviewed journals, and conferences. Oversight of the study is being provided by an Independent Data Monitoring Committee and an independent Trial Steering Committee (TSC). The Trial Management Group (TMG) meets every month.
Clinical research in emergency and critical care is vital, but recruitment and consent are complex. Research may be conducted without prior consent when patients are critically ill, and interventions are time critical. Some patients may die before research participation can be discussed with relatives, leaving the bereaved unaware of their involvement. This study explored potential communication strategies for informing bereaved relatives when a patient has died following enrolment into an emergency or critical care study without prior consent.
A mixed-methods study using a telephone survey and semi-structured interviews conducted simultaneously. The survey was conducted within a National Health Service Trust in North West England with relatives of deceased study participants. Semi-structured interviews were conducted with bereaved relatives and research and clinical staff across the UK, and medical examiner (ME)/ME officers based in England and Wales. Quantitative data were analysed descriptively, and qualitative data were analysed using reflexive thematic analysis. Data were synthesised using a constant comparison approach.
11 bereaved relatives completed the survey. 53 individuals (21 research and clinical staff, 18 relatives and 14 MEs/officers) participated in semi-structured interviews.
Although many trials do not include a process for notifying bereaved relatives about research participation, most relatives valued the opportunity to learn about their family member’s participation, emphasising the importance of transparency and trust. However, some raised concerns over the potential burden of automatic disclosure by the ME service. Offering bereaved relatives the option to receive sensitively worded information about research involvement at an appropriate time, soon after death, was recommended.
Bereaved relatives should have the choice to be informed about research participation without prior consent. Our findings support the need for transparent and sensitive communication and will contribute to future guidance for the design and conduct of adult emergency and critical care studies.
Nigeria has the highest number of maternal deaths globally, and maternal peripartum sepsis is one of the leading causes of maternal mortality. A single oral dose of azithromycin (AZM; 2 g) is safe and effectively reduces 33%–60% of maternal sepsis during planned vaginal birth in low- and middle-income countries (LMICs). However, the clinical and cost-effectiveness of oral AZM during vaginal birth in Nigeria remains unknown in the context of poor antimicrobial stewardship practices, significant antimicrobial resistance and healthcare financing. Evidence is also lacking on the standard care for the prevention of maternal sepsis among pregnant women undergoing vaginal births in Nigeria. The AZIN-V trial is a hybrid type 2 effectiveness-implementation trial to determine the safety, clinical and cost-effectiveness of intrapartum oral AZM versus usual care in the prevention of peripartum maternal sepsis. The trial will also examine the impact of implementation strategies in enhancing adherence to the oral AZM protocol during planned vaginal births and identify effective strategies to improve adherence (fidelity) to the protocol in real-world LMIC settings.
This is a multicentre hybrid type 2 trial conducted in six Nigerian states: Ebonyi, Edo, Gombe, Kano, Kwara and Lagos. The study aims to simultaneously test the clinical and cost-effectiveness of AZM (clinical trial) and the impact of implementation strategies (implementation research) in Nigeria’s unique healthcare context. The clinical trial is a two-arm, cluster-randomised controlled trial conducted across 48 health facilities, randomly assigned (1:1) to either intrapartum administration of oral AZM (intervention group) or usual care—the current routine practice (control group). A total of 5040 study participants (2520 in each group) will be enrolled in the clinical trial. The implementation trial is a two-arm cluster non-randomised controlled trial conducted in 12 health facilities (1:1) allocated to either a bottom-up approach using the Plan-Do-Study-Act cycle or a usual top-down approach with a one-time training workshop and distribution of clinical guidelines, with both arms administering oral AZM during vaginal birth while assessing fidelity (primary outcome).
For the clinical trial, data will be analysed using intention-to-treat statistical methods. The cost-effectiveness outcome will be analysed using the Incremental Cost-Effectiveness Ratio. Implementation outcomes will be analysed using descriptive statistics and a thematic approach.
This study has been approved by the National Health Research Ethics Committee, Nigeria (NHREC/01/01/2007-30/09/2024), the ethics committees of the participating health institutions (Lagos University Teaching Hospital Research Ethics Committee: ADM/DSCST/HREC/APP/6325; University of Ilorin Teaching Hospital Health Research Ethics Committee: ERC/PAN/2025/03/0581; University of Benin Teaching Hospital Health Research Ethics Committee: ADM/E22/A/VOL. VII/483117141; Aminu Kano Teaching Hospital Research Ethics Committee: AKTH/MAC/SUB/12 A/P-3/VI/2509 and Irrua Specialist Teaching Hospital Research Ethics Committee: ISTH/HREC/20241507/605), the Ministries of Health of the six states and the National Agency for Food and Drug Administration and Control. Written informed consent will be obtained from all eligible study participants before enrolment. Results will be shared with communities and policy stakeholders and through peer-reviewed journals and will be presented at conferences.
Diagnostic errors in primary care are common, particularly in the interpretation and follow-up of abnormal haemoglobin (Hgb) and estimated glomerular filtration rate (eGFR) results. These errors frequently result in missed or delayed diagnoses of serious conditions such as anaemia and chronic kidney disease. This protocol describes a stepped-wedge cluster randomised controlled trial designed to evaluate a novel, evidence-based, team-based intervention aimed at improving diagnostic safety and efficiency.
The study will be conducted across 12 University of Texas Physicians (UTPs) primary care clinics in Houston, Texas, USA. Adult patients (≥18 years) with newly identified abnormal Hgb or eGFR results will be eligible for inclusion. The intervention integrates automated tracking of abnormal laboratory results, nurse navigators to support patient follow-up and engagement, and clinical pathologists to provide diagnostic guidance to primary care providers. The primary outcome is diagnostic safety, defined as the proportion of patients who receive a correct diagnosis within 6 months. Secondary outcomes include diagnostic efficiency, appropriate test utilisation, cost-effectiveness, patient activation and implementation metrics such as acceptability, fidelity and sustainability. The study will also explore barriers and facilitators to successful implementation using mixed-methods evaluation.
This trial has been approved by the Institutional Review Board at The University of Texas Health Science Center at Houston. Study results will be disseminated through peer-reviewed publications and conference presentations, and findings will be reported to UTP leadership to inform potential system-wide implementation.
A growing number of national diagnostic reference levels based on clinical indications (NDRLci) in CT have been implemented worldwide since the International Commission on Radiological Protection’s 2017 recommendation. This study aims to compare NDRLci practices, identify influencing factors and propose evidence-based recommendations for NDRLci development, based on the literature published between 1996 and 2025.
Systematic review.
A systematic literature search was conducted in PubMed, Web of Science and Scopus from 1996 to 24 august 2025. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis framework was followed to report the study selection process in this review. Joanna Briggs Institute’s critical appraisal tools were used to evaluate the articles critically.
Adult patients undergoing CT scans for various clinical indications.
Clinical indication-based CT protocols with reported NDRLci values as CT dose index volume and dose length product (DLP).
The primary outcomes were NDRLci values reported for various clinical indications. The secondary outcomes were CT technology, protocol parameters and patient characteristics influencing NDRLci.
A total of 4146 articles were identified. 410 full texts were examined and 11 studies were included in the systematic review. 25 clinical indications across seven anatomical regions were identified across 11 included studies. The NDRLci for urinary stones and cerebrovascular accident had the highest number of references, while flank pain and occlusion had the lowest number. The highest NDRLci in DLP was found for total body CT in severe trauma (3830 mGy cm) and the lowest for sinusitis (70 mGy cm).
Several factors contribute to dose discrepancies for the same clinical indications in CT imaging, including kilovolt peak and milliampere-second, scan length, number of phases, patient size, reconstruction algorithm, CT scanner age and specifications, underscoring the need for standardised and optimised CT protocols. This review highlighted several challenges, which emphasise the importance of international organisations to standardise the development of NDRLci to improve comparability across countries.
CRD42024603574.
The Generation Study is a large-scale research initiative led by Genomics England in partnership with the National Health Service, aiming to evaluate the use of whole genome sequencing in newborn screening, as well as ongoing research use of these genomic data. The Generation Study will sequence 100 000 newborn genomes in England to potentially identify approximately 200 rare and treatable conditions. This paper outlines the study’s approach to embedding ethics from inception through implementation. A model of ‘ethical embeddedness’ that emphasises transparency, trustworthiness and responsiveness to uncertainty is utilised. Drawing on the deliberations of a multidisciplinary Ethics Working Group, public dialogue findings and design research, the paper presents key decisions and our approach to complex ethical challenges including consent, potential impact of the study on clinical services and navigating uncertainty. The paper also reflects on the ethical tensions inherent in balancing research ambitions with operational realities, particularly in a context of evolving genomic science and sometimes limited regulatory clarity. By embedding ethics into the study’s design and delivery, we hope to foster public trust and inform future policy and practice.
Older people who identify as lesbian, gay, bisexual, trans, queer or other marginalised sexualities and gender identities (LGBTQ+) still face significant barriers and inequalities when accessing adult social care services. Little is known about the preparedness of the care workforce to support older LGBTQ+ individuals, particularly within home care services. While a few previous reviews have examined the perspectives of older LGBTQ+ people on the preparedness of the home care workforce, none have included the perspectives of the workforce itself or compared both perspectives. This is a protocol for a rapid review that aims to explore what is known about the preparedness and practice needs of the home care workforce to support older LGBTQ+ people, with a particular focus on workforce perspectives.
A rapid review method was selected to expedite the review process to support further study development and dissemination. Two electronic databases, SCOPUS and Web of Science, will be searched, as well as six subject-specific databases, including Social Care Institute for Excellence, Skills for Care, Social Care Wales, Homecare Association, Stonewall UK, LGBT Foundation UK and SAGE US. There are no search date restrictions. Study quality will be assessed using the Quality Assessment with Diverse Studies tool and the Grading of Recommendations, Assessment, Development and Evaluations considerations will be used to consider certainty of evidence. Data will be synthesised using narrative synthesis, including a descriptive summary of included studies and their methodological quality. All preferred reporting items for review protocols have been included, as recorded by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol.
Ethical approval is not required for the protocol and review. Manuscripts for the protocol and completed review will be submitted to a peer-reviewed journal, and findings will be shared in webinars for the home care workforce and at academic conferences.
CRD420251038242.
by Artiom Gruzdev, Wendy N. Jefferson, Thomas B. Hagler, Gregory J. Scott, Manas K. Ray, Ginger W. Muse, Rani S. Sellers, Carmen J. Williams
FVB/N mice, which are commonly used for cancer studies, have accelerated onset of endometrial cancer following developmental estrogenic chemical exposure. These mice also have a polymorphism in the mitochondrial gene, mt-Atp8, leading to increased production of reactive oxygen species. We hypothesized that this polymorphism contributes to the enhanced endometrial cancer phenotype in FVB/N mice. To test this idea, we generated conplastic FVB/N-mt129S6/SvEvTac mice (FVB/N nuclear genome; 129S6/SvEvTac mitochondria: FVB/N-mt129). The impact of 129S6 versus FVB/N mitochondrial genomes on endometrial cancer development following neonatal exposure to the xenoestrogen, diethylstilbestrol, was tested by comparing the cancer phenotypes of FVB/N mice to FVB/N-mt129 mice. There was no difference in cancer incidence regardless of mitochondria source, but cancer grade was higher in the conplastic strain. Additionally, while the FVB/N genetic background is considered non-permissive for generation of pluripotent mouse embryonic stem cells, blastocysts from the conplastic background readily generated mouse embryonic stem cell clones that supported gene editing in culture and subsequently generated germline competent chimeric founder mice. FVB/N-mt129 mice are a potentially powerful resource for generating germline competent embryonic stem cells with an FVB/N nuclear genome and for studying cancer phenotypes.by Michelle Lauge Quaade, Mikael Leijon, Mikhayil Hakhverdyan, Thomas Bruun Rasmussen, Charlotte Kristiane Hjulsager, Lars Andresen, Karin Mundbjerg, Anne Sofie Vedsted Hammer
Diarrhea outbreaks significantly affect the health and growth of farmed mink, posing economic and welfare challenges. While various pathogens have been linked to mink diarrhea, the causes during the weaning period remain unclear. Sporadic associations of mink coronavirus (MCoV), Campylobacter, and gastrointestinal disease in mink have been suggested. This study investigates the occurrence and levels of MCoV and Campylobacter in fecal samples from Danish farm mink (Neogale vison) and their potential association with post-weaning anorexia diarrhea syndrome (PADS), growth-period diarrhea (GPD), or pre-weaning diarrhea (PWD). The focus of the study is on PADS, studied through two case-control setups where case farms had known problems with PADS and control farms without such problems. Animals were also diagnosed based on necropsy pathological findings. Seventeen MCoV genomes were determined from five Danish farms. This data facilitated the development of an MCoV RT-qPCR and was applied across three study groups. Results showed high prevalence of both MCoV and Campylobacter spp. in all groups. No link was found between MCoV presence or levels and PADS diagnosis on the individual level; however, farm-level analysis revealed that MCoV was 2.35 times more likely (95% CI 1.027; 5.056) on PADS case farms than controls. Mink with PWD exhibited higher MCoV levels compared to GPD cases, suggesting a role at this developmental stage. Phylogenetic analysis revealed diverse and farm-specific MCoV strains, with sequences from healthy controls forming a distinct subclade, hinting at strain-specific pathogenicity. Campylobacter spp. presence was not significantly associated with PADS, but higher levels were observed in mink with PADS versus those without (not tested for PWD). These findings highlight the importance of surveillance and rigorous hygiene practices on mink farms to address risks from MCoV and Campylobacter spp., calling for further research to clarify their roles in PADS and overall mink health.Shared decision-making is widely advocated in policy and practice, but how it is to be applied in a high-stakes clinical decision such as major lower limb amputation due to chronic limb-threatening ischaemia or diabetic foot is unclear. The aim of this study was to explore the communication, consent, risk prediction and decision-making process in relation to major lower limb amputation.
A qualitative study (done as part of a broader mixed-methods study) using semi-structured interviews. Interview transcriptions were analysed using thematic analysis.
Vascular centres in three large National Health Service hospitals in Wales and England, UK, between 1 October 2020 and 30 September 2022.
A purposive sample of 18 patients for whom major lower limb amputation was considered as a treatment option/carried out, with interviews conducted before or within 4 months of amputation and 4–6 months after amputation. A further purposive sample of 20 healthcare professionals (including eight surgeons) involved in supporting or conducting major lower limb amputation decision-making.
Five major categories were identified that highlighted the challenges of ensuring shared decision-making associated with major lower limb amputation: (i) patients’ limited understanding, (ii) variable patient attitudes to decision-making, (iii) healthcare professionals’ perceived challenges to sharing decision-making, (iv) surgeons’ paternalism and (v) patients’ and healthcare professionals’ decisional regret/possible consequences of challenges.
Amputation is a life-changing decision for both patients and healthcare professionals, with huge consequences. Despite being considered the gold standard, our findings highlight several challenges to effective shared decision-making for major lower limb amputation. Shared decision-making training for healthcare professionals is paramount if these limitations are to be addressed and patients are to feel confident in being adequately informed about the treatment decisions that they make.
Venous leg ulcers (VLU) account for the majority of chronic wounds, with an estimated rise in prevalence due to demographic change. Care often does not comply with evidence, and patients remain passive and uninformed. To support general practice VLU care, the ‘UlcusCrurisCare’ (UCC) project developed a multimodal intervention comprising provider training, software-supported case management and standardised patient education. Experts from the medical community (physicians, nurses, association of medical assistants), health insurance and patient representatives provided their assessment of barriers in VLU care, requirements for intervention components and their expected effects. Semi-structured interviews and questionnaires were used at two measuring points. Qualitative data analysis was based on the Theoretical Domains Framework. Quantitative data were analysed descriptively. Ten experts named a lack of knowledge and application regarding compression therapy, reluctance to assume role as primary care provider, and inadequate remuneration as barriers for evidence-based VLU care. To effectively address these barriers, interventions are required to foster the use of compression therapy and patient education. A multimodal approach such as pursued in UCC is expected to effectively address deficits in VLU care at general practitioner level by promoting provider knowledge about evidence-based treatment and supporting patient adherence.
by Angelina Miller, Katja Lisa Schröder, Karsten Eike Braun, Caitlin Steindorf, Richard Ottermanns, Martina Roß-Nickoll, Henner Hollert, Thomas Backhaus
Zebrafish (Danio rerio) are widely used in biological research, but the impact of incubation temperatures on developmental endpoints is still insufficiently studied. This study quantifies developmental differences in zebrafish embryos incubated at 26°C and 28°C, focusing on key endpoints (heartbeat onset, hatching time, eye size, yolk sac consumption, and body length). For this purpose, we recorded a high-resolution time series comprising hourly observations of early developmental stages and key events and bi-hourly observations of body length until 120 hours post fertilization. Additionally, we recorded a low-resolution time series at 72, 96, and 119 hours post fertilization for detailed measurements of eye size, yolk sac area, and body length. Embryos incubated at 26°C showed consistent delays in developmental stages compared to those at 28°C, with delays becoming more pronounced at later stages. Yolk sac consumption was delayed by about 19.8 hours at 26°C by 119 hours post fertilization, suggesting a delayed onset of independent feeding. These findings suggest that time-based regulatory limits for rearing zebrafish, such as the 120-hour threshold in German regulations (TierSchVerV), do not fully account for temperature-dependent development. The results emphasize the need for guidelines linking incubation temperatures to developmental progress.We conducted a pilot randomised controlled trial (the PHaCT study), including a process evaluation to assess the acceptability of a housing-led Critical Time Intervention (CTI) for prison leavers and the use of a trial design. This paper presents the process evaluation findings.
To explore the acceptability of both the intervention and the trial design to participants and those delivering the intervention, and to assess whether the intervention was delivered with fidelity.
A process evaluation following Medical Research Council guidelines. Data collection included semi-structured interviews with participants and CTI caseworkers and observations of intervention delivery. A thematic analysis of interviews and observations was conducted to understand the intervention’s implementation and contextual factors as well as the trial process acceptability.
Participants for the pilot trial were recruited from three prisons in England and Wales where the intervention was being delivered.
While 28 out of 34 trial participants consented to interviews, only one was completed. Seven caseworkers were interviewed.
A housing-led CTI to support people leaving prison at risk of homelessness, involving phased, time-limited support from caseworkers, starting prerelease and continuing postrelease, to help secure stable housing and build independence, without directly providing housing.
The intervention’s acceptability was primarily reflected through the positive feedback and success stories shared by CTI caseworkers, as well as observational data indicating high acceptance among service users. The trial design’s acceptability was challenged by concerns about randomisation and equipoise, with staff viewing randomisation as unethical due to limited support for vulnerable populations. The fidelity to the CTI intervention housing-led approach was adhered to as best as possible; stable housing was prioritised for service users before addressing other needs. Despite these efforts, both sites encountered significant challenges due to limited housing availability and complex systems for securing social housing, particularly for single men leaving prison.
This wider study faced significant challenges which impacted the process evaluation. Despite these issues, the evaluation provides important insights into the challenges of conducting trials on interventions for people leaving prison. The challenges experienced should inform future study designs with similar populations and in similar settings.
To determine whether a full-scale randomised control trial (RCT) assessing the efficacy and cost-effectiveness of a housing led Critical Time Intervention (CTI) is feasible and acceptable.
Pilot parallel two-arm individual level RCT, including process evaluation and embedded exploratory health economic evaluation.
Four prisons for men across England and Wales, UK.
Men leaving prison at risk of homelessness and intervention delivery staff.
CTI has four components: (1) pre-engagement phase: assessing the needs of the client and implementing a plan pre-discharge; (2) transition to community: forming relationships and goal setting; (3) try out: encouraging problem-solving and managing practical issues and (4) transfer of care: developing long-term goals and transferring responsibilities to community providers.
Progression criteria: recruitment, retention, acceptability of the processes (CTI and trial method) and fidelity of intervention delivery. We also assessed the completeness of primary, secondary and exploratory outcome measures and estimated intervention costs.
The recruitment progression criterion was met, with 92% (34/37) of approached individuals consenting to participate (target: 50%). However, the overall recruitment target of 80 was not achieved, and retention was low, only 18% (6/34) provided follow-up data, well below the 60% threshold. Retention was hindered by systemic challenges, including changes to prison release policies and reduced probation support. While the CTI model was acceptable to staff and service users, the trial design, particularly randomisation, was not. Intervention fidelity met the progression criteria. Baseline data collection for health economics and resource use was feasible, and intervention costs were estimated.
This pilot trial identified significant challenges to conducting a full-scale RCT of CTI in this context, particularly around retention, trial acceptability and systemic instability. While CTI remains a promising model, a traditional RCT design may not be viable in this setting without substantial structural and ethical adaptations.
FreshRSS 