Neonatal haemochromatosis, considered to be a gestational alloimmune liver disease (NH-GALD), is a rare but serious disease that results in fulminant hepatic failure. The recurrence rate of NH-GALD in a subsequent infant of a mother with an affected infant is 70%–90%. Recently, antenatal maternal high-dose intravenous immunoglobulin (IVIG) therapy has been reported as being effective for preventing recurrence of NH-GALD in a subsequent infant. However, no clinical trial has been conducted to date.

This is a multicentre open-label, single-arm study of antenatal maternal high-dose IVIG therapy in pregnant women with a history of documented NH in a previous offspring. The objective of this study is to evaluate the efficacy and safety of antenatal maternal high-dose IVIG therapy in preventing or reducing the severity of alloimmune injury to the fetal liver.

The clinical trial is being performed in accordance with the Declaration of Helsinki. The trial protocol was approved by the Clinical Research Review Board at four hospitals. Before enrolment, written informed consent would be obtained from eligible pregnant women. The results are expected to be published in a scientific journal.

28 October 2024, V.8.0.

jRCT1091220353.

This study explored how Structured Medication Reviews (SMRs) are being undertaken and the challenges to their successful implementation and sustainability.

A cross-sectional mixed methods online survey.

Primary care in England.

120 clinical pharmacists with experience in conducting SMRs in primary care.

Survey responses were received from clinical pharmacists working in 15 different regions. The majority were independent prescribers (62%, n=74), and most were employed by Primary Care Networks (65%, n=78), delivering SMRs for one or more general practices. 61% (n=73) had completed, or were currently enrolled in, the approved training pathway. Patient selection was largely driven by the primary care contract specification: care home residents, patients with polypharmacy, patients on medicines commonly associated with medication errors, patients with severe frailty and/or patients using potentially addictive pain management medication. Only 26% (n=36) of respondents reported providing patients with information in advance. The majority of SMRs were undertaken remotely by telephone and were 21–30 min in length. Much variation was reported in approaches to conducting SMRs, with SMRs in care homes being deemed the most challenging due to additional complexities involved. Challenges included not having sufficient time to prepare adequately, address complex polypharmacy and complete follow-up work generated by SMRs, issues relating to organisational support, competing national priorities and lack of ‘buy-in’ from some patients and General Practitioners.

These results offer insights into the role being played by the clinical pharmacy workforce in a new country-wide initiative to improve the quality and safety of care for patients taking multiple medicines. Better patient preparation and trust, alongside continuing professional development, more support and oversight for clinical pharmacists conducting SMRs, could lead to more efficient medication reviews. However, a formal evaluation of the potential of SMRs to optimise safe medicines use for patients in England is now warranted.

Endometriosis is a chronic condition affecting up to 11% of people presumed female at birth by the age of 44 years, characterised by the growth of tissue similar to the lining of the uterus on other organs. Endometriosis significantly impacts health-related quality of life (HRQoL) and imposes a substantial burden on both individuals and the healthcare system. International guidelines recommend the interdisciplinary management of endometriosis due to its significant biopsychosocial burden; however, research aimed at exploring psychological approaches for endometriosis is limited. This trial aims to evaluate the effectiveness of CodeEndo, an online co-designed interdisciplinary supportive care program, compared with a waitlist control (WLC), on HRQoL and biopsychosocial outcomes in people with a diagnosis of endometriosis.

A hybrid type 1 effectiveness and implementation randomised controlled trial (RCT) will be conducted. Eligible participants will be randomly allocated to either the CodeEndo program (n=176) or WLC group (n=176) for 8 weeks. The primary outcome will be HRQoL, and secondary outcomes will include psychological symptoms (anxiety, depression, stress), self-efficacy, menstrual, bladder and gastrointestinal symptoms, pain, fatigue, sleep, exercise, diet, symptom bothersomeness and physical and psychological well-being, measured at 8 weeks post-randomisation (T2) and 6-month follow-up (T3). Cost-effectiveness will also be examined. Longitudinal qualitative individual interviews (up to n=40) will be conducted with participants who complete the CodeEndo program to explore benefits, barriers and facilitators of ongoing use. Additionally, the CodeEndo program will undergo evaluation by a group of endometriosis healthcare providers, who will assess potential barriers and facilitators to its real-world implementation. Various process evaluation strategies will also be measured to inform future implementation. Data analyses will incorporate mixed-effects regression models on an intention-to-treat basis, cost-consequences and cost-utility, dietary and qualitative thematic analysis.

This protocol received ethics approval from Deakin University Research Ethics Committee (DUREC Ref: 2024-157). Dissemination is expected to include peer-reviewed journal articles, reports, conference presentations as well as websites or social media platforms of relevant chronic pain organisations. Participants will be sent a summary of trial results.

ACTRN12623000598684p.

Cancer remains a major public health concern worldwide. Patient navigation, developed in the 1990s to address disparities in cancer outcomes, aims to guide patients through the complex healthcare system and improve access to timely, quality care. Despite its proven benefits, little is known about the implementation or impact of patient navigation programmes in African settings.

This scoping review aims to map the current evidence on components, procedures, outcomes and impact, as well as barriers and challenges to implementation of patient navigation programmes in cancer care across Africa.

This scoping review will follow Arksey and O’Malley’s scoping review framework, as further developed by Levac et al. A systematic search will be conducted across PubMed, African Journals Online and Google Scholar to identify relevant studies published from database inception to the date of the final search, using a combination of relevant keywords and MeSH terms. Eligible studies must be reported in English, have been carried out in Africa, involved patients diagnosed with cancer or navigating the cancer care continuum, and report on the description, implementation or evaluation of patient navigation programmes. Screening will be managed with Rayyan and carried out through a two-stage process: screening by titles and abstracts, then by full-text screening based on the prespecified inclusion and exclusion criteria. Data will be extracted into a structured Excel spreadsheet and synthesised using qualitative content analysis to identify programme characteristics, outcomes, barriers and implementation challenges.

This scoping review does not require ethical approval. Our findings will be published in a peer-reviewed, open-access journal on completion.

To assess the time to first optimal glycaemic control and its predictors among adult patients with type 1 and type 2 diabetes at the University of Gondar Comprehensive Specialized Hospital in Ethiopia.

A retrospective cohort study.

University of Gondar Comprehensive Specialized Hospital, northwest, Ethiopia.

We recruited 423 adult diabetic patients who were diagnosed between 1 January 2018 and 30 December 2022 at the University of Gondar Comprehensive Specialized Hospital.

The primary outcome was the time from diagnosis to the achievement of the first optimal glycaemic control, measured in months. A Cox proportional hazards regression model was fitted to identify predictors of time to first optimal glycaemic control. Data were collected with KoboToolbox from patient medical charts and exported to Stata V.17. The log-rank test was used to determine the survival difference between subgroups of participants.

Median time to first optimal glycaemic control was 10.6 months. Among 423 adult diabetic patients, 301 (71.16%) achieved the first optimal glycaemic control during the study period. Age category (middle age (adjusted HR (AHR)=0.56, 95% CI 0.41 to 0.76), older age (AHR=0.52, 95% CI 0.33 to 0.82)), comorbidity (AHR=0.52, 95% CI 0.35 to 0.76), therapeutic inertia (AHR=0.20, 95% CI 0.13 to 0.30) and medication non-compliance (AHR=0.49, 95% CI 0.27 to 0.89) were significant predictors of time to optimal glycaemic control.

The median time to first optimal glycaemic control was prolonged. Diabetic care should focus on controlling the identified predictors to achieve optimal glycaemic control early after diagnosis.

Hepatitis C virus (HCV) remains a leading cause of infectious disease-related morbidity in the USA, disproportionately affecting people who inject drugs and people who are incarcerated. Despite the availability of highly effective, highly tolerated direct-acting antivirals, treatment uptake in jails remains limited due to short stays, unpredictable release dates and system-level barriers. The original MINMON trial demonstrated that a low barrier ‘minimal monitoring"’ model can achieve high cure rates in community settings. This study, MINMON-J, aims to adapt and evaluate a modified version of the MINMON model for use in a jail setting, addressing the urgent need for scalable, low-barrier treatment approaches among justice-involved individuals.

MINMON-J is a single-arm, hybrid effectiveness-implementation pilot study protocol planned to recruit at the Rhode Island Department of Corrections. 40 people who are incarcerated with positive HCV RNA, who are treatment-naïve, without cirrhosis and awaiting trial, will receive 12 weeks of sofosbuvir/velpatasvir with no required lab monitoring during treatment. If released before treatment completion, participants will receive their remaining medication at discharge. Community health workers will provide post-release support. Mixed-methods evaluation will be guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance/Practical, Robust Implementation and Sustainability Model framework. Primary outcomes include feasibility, acceptability and adherence. Data will be collected through administrative records, surveys (Acceptability of Intervention Measure, Feasibility of Intervention Measure, Brief Adherence Rating Scale) and qualitative interviews with participants and other relevant parties. This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections Medical Research Advisory Group.

This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections (RIDOC) Medical Research Advisory Group. All participants will provide written informed consent prior to enrolment. People who are incarcerated will be assured that participation is voluntary, will not impact their clinical care and that they may withdraw at any time without penalty. Study procedures follow ethical principles outlined in the Declaration of Helsinki and comply with federal regulations regarding research involving vulnerable populations.

Dissemination of findings will include peer-reviewed publications and presentations at national conferences focused on infectious diseases, implementation science and/or correctional health. Lay summaries will be shared with RIDOC leadership and community partners. De-identified data and associated metadata may be archived in a publicly accessible repository in accordance with National Institutes of Health data sharing policies, contingent on final institutional review board approval and participant protections.

NCT06953479.

There are global concerns about the rise in opioid prescribing. Patients undergoing potentially curative surgery for colorectal cancer (CRC) are at high risk of adverse outcomes from opioid-related complications, including delayed discharge and adjuvant chemotherapy, long-term opioid use and reduced cancer-free survival. We aimed to develop a set of actionable quality indicators for opioid stewardship for patients undergoing CRC surgery, and an implementation toolkit to support professional behaviour change to improve appropriateness of perioperative opioid prescribing.

A five-round modified RAND consensus process was conducted in 2021–2024.

14 secondary care trusts across the UK Yorkshire and Humber region.

Consultant anaesthetists and national perioperative opioid stewardship experts (expert panel) and patient and public panel.

Potential indicators were identified from a literature review, guideline search and expert panel. All potential indicators were rated on relevance and actionability (online survey, expert panel) and importance to patient care (online meeting, patient panel). A hybrid consensus meeting involving a patient representative and the expert panel discussed and rerated the indicators. An online expert survey identified potential barriers to implementation. An actionable toolkit was developed using implementation strategies and supporting resources developed where appropriate.

73 potential indicators were identified. All indicators remained in the process through the online survey and patient panel. After the final meeting, four indicators remained: (1) hospital trust presence of an opioid stewardship protocol; (2) inpatient functional post-operative pain assessments; (3) patient education and discharge leaflet; and (4) senior clinician review of ‘strong’ opioids on discharge (British National Formulary definition). The number of barriers identified ranged from 8 to 22 per indicator. 49 different implementation strategies were identified for the toolkit (range 32–45 per indicator).

We identified four actionable quality indicators and developed an implementation toolkit that represents consensus in defining quality of care in opioid stewardship for CRC surgery.

Diabetic retinopathy (DR) in pregnancy can cause blindness. National guidelines recommend at least one eye examination in early pregnancy, then ideally 3-monthly, through to the postpartum for pregnant women with pregestational diabetes. Here we examined adherence rates, barriers and enablers to recommended DR screening guidelines.

Cross-sectional survey study, as part of a larger prospective cohort study.

Participants were recruited from two tertiary maternity hospitals in Melbourne, Australia.

Of the 173 pregnant women with type 1 (T1D) or type 2 diabetes (T2D) in the main cohort study, with an additional four who participated solely in this survey study, 130 (74.3%) completed the survey.

This study calculated rates of adherence to guideline-recommended DR screening schedules and collected data on the enablers and barriers to attendance using a modified Compliance with Annual Diabetic Eye Exams Survey. Each of the 5-point Likert-scale survey items was compared between adherent and non-adherent participants using the Wilcoxon rank-sum test and logistic regression models were constructed to quantify associations as ORs.

A retinal assessment was undertaken at least once during pregnancy in 86.3% of participants, but only 40.9% attended during their first trimester and only 21.2% attended the recommended number of examinations. Competing priorities were the main barriers to adherence, with eye examinations ranked as the fourth priority (IQR 4th–5th) among other health appointments during pregnancy. Meanwhile, knowledge of the benefits of eye screening examinations, eye-check reminders and support from relatives was identified as enablers.

Despite the risk of worsening DR during pregnancy, less than half of the participants adhered to recommended screening guidelines, suggesting that eye health is not a priority. Proactive measures to integrate care are needed to prevent visual loss in this growing population.

Inherited retinal diseases (IRDs) are a broad range of diseases associated with abnormalities/degeneration of retinal cells. We aimed to identify the top 10 Australian research priorities for IRDs to ultimately facilitate more meaningful and potentially cost-effective research.

We conducted a James Lind Alliance priority setting partnership that involved two Australian-wide surveys and online workshops.

Australia-wide.

Individuals aged 16 years or older were eligible to participate if they had an IRD, were caregivers of an individual with an IRD or were health professionals providing care to this community.

In Survey 1, we gathered participants’ unanswered questions about IRDs. We grouped these into summary questions and undertook a literature review to verify if they were truly unanswered (ie, evidence uncertainties). In Survey 2, participants voted for the uncertainties that they considered a priority. Top-ranked uncertainties progressed for discussion and final prioritisation in two workshops.

In Survey 1, we collected 223 questions from 69 participants. We grouped these into 42 summary questions and confirmed 41 as evidence uncertainties. In Survey 2, 151 participants voted, with the 16 uncertainties progressing to final prioritisation. The top 10 priorities, set by the 24 workshop participants, represented (1) treatment/cure; (2) symptoms and disease progression; (3) psychosocial well-being and (4) health service delivery. The #1 priority was for treatment to prevent, slow down or stop vision loss, followed by the #2 priority to address the psychological impact of having an IRD.

The top 10 research priorities highlight the need for IRD research that takes a whole-person, systems approach. Collaborations to progress priorities will accelerate the translation of research into real-world benefits.

The Quadrivalent human papillomavirus (HPV) Vaccine Evaluation Study with Addition of the Nonavalent Vaccine Study (QUEST-ADVANCE) aims to provide insight into the long-term immunogenicity and effectiveness of one, two and three HPV vaccine doses. Here, we describe the protocol for QUEST-ADVANCE.

QUEST-ADVANCE is an observational cohort study including males and females who are unvaccinated or vaccinated with the quadrivalent or nonavalent HPV vaccine in British Columbia, Canada. Female participants who are unvaccinated or vaccinated with 1–3 doses of the quadrivalent or nonavalent HPV vaccine at 9–14 years of age will be recruited approximately 5 or 12 years postvaccination eligibility. Male participants who are unvaccinated or vaccinated with 1 or 2 doses of the nonavalent HPV vaccine at 9–14 years of age will be recruited at approximately 5 years postvaccination eligibility. The study involves a maximum of four visits over a period of 4–5 years for female participants, and two visits over a 12-month period for male participants. At each visit, self-collected swabs (cervico-vaginal or penile) and questionnaire data will be collected. In each study group, a subset of participants will be invited to participate in a substudy evaluating the long-term humoral immunogenicity of the HPV vaccine. Additional blood samples will be collected from participants who are part of the immunogenicity substudy. The total required sample size is 7180 individuals. The primary objectives are (1) to examine vaccine effectiveness in males and females against prevalent genital HPV infections for one, two and three doses of the HPV vaccine compared with unvaccinated participants and (2) to evaluate if there is non-inferior immunogenicity as indicated by type-specific antibody response of one dose of the HPV vaccine in 20–27-year-old females vaccinated at 9–14 years of age compared with historical data of three doses of the HPV vaccine females vaccinated at 16–26 years of age up to 12 years postvaccination.

QUEST-ADVANCE was approved by the Research Ethics Board of the University of British Columbia/Children’s and Women’s Health Centre of British Columbia (H20-02111). Individual electronic informed consent or assent will be obtained from each participant before any study-specific procedures are undertaken. Results will be published in an international peer-reviewed journal and on the study website.

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) entails substantial morbidity and mortality, yet no epidemiologic evidence exists on its outcomes in Mexico. This study assessed national hospitalisations (2005–2022) and mortality (2000–2022) related to AAV using data from the General Board of Health Information.

Retrospective, population-based time-trend analysis on administrative health data.

Mexico’s national hospital discharge and mortality registries, covering 1 January 2000 through 31 December 2022.

All individuals aged ≥ 15 years with a primary or secondary International Classification of Diseases, 10th revision, diagnosis of AAV recorded during hospitalisation or on death certificates nationwide.

The study’s primary outcomes were the age-standardised hospitalisation and mortality rates for AAV (expressed per 100 000 population, overall and by sex), with temporal trends in both rates quantified using Joinpoint regression to calculate annual percent change (APC) and average APC (AAPC).

We identified 2804 hospitalisations and 599 deaths. Females accounted for 49.7% of hospitalisations, while males represented 48.7% of deaths. Although the overall age-standardised hospitalisation rate (ASHR) and mortality rate (ASMR) AAPCs were not statistically significant, relevant trends emerged. From 2010 to 2022, ASHR declined significantly (APC: –5.2%; 95% CI –9.7, –0.5; p=0.03), whereas mortality rates remained stable from 2000 to 2022 (AAPC: +3%; 95% CI –4.6, 11.3; p=0.45). Nevertheless, mortality increased among males (APC: +6.4%; 95% CI 0.9, 12.2; p=0.02) and individuals over 45 years (APC: +8.6%; 95% CI 1.7, 16.0; p=0.02) from 2008 onwards.

Overall, these findings indicate no major changes in national rates but reveal a decline in hospitalisations since 2010 and a rise in mortality for specific subgroups since 2008. Targeted interventions, particularly for older adults and men, appear warranted to address this evolving disease burden. Future research should explore underlying risk factors and evaluate tailored strategies to improve clinical outcomes in AAV across Mexico.

To explore how pre-existing conditions affect the diagnostic process for potential cancer in primary care patients.

Qualitative interview study using thematic analysis underpinned by a critical realist approach.

Primary care practices recruited through four Clinical Research Networks and UK health charities across England.

Interviews were conducted with 75 patients with one or more pre-existing conditions (anxiety/depression, diabetes, obesity, chronic obstructive pulmonary disease, Parkinson’s disease or multiple long-term conditions (four or more)) and 28 primary care professionals (general practitioners and nurses).

The study identified legitimacy as a central theme influencing patient trajectories in the health system while trying to receive a diagnosis for symptoms with which they presented to primary care. Patients engaged in self-triage to determine whether symptoms were ‘legitimate’ enough to seek care. Subsequent triaging steps (by receptionists, nurses and online systems) acted as gatekeepers, with decisions influenced by effectiveness of describing the symptom and subjective impressions. During consultations, clinicians relied on a mix of symptom narrative clarity, medical history and objective ‘metrics’ (eg, blood results, family history) to determine legitimacy for further investigations. Pre-existing conditions could either lower the threshold for referrals or obscure potential cancer symptoms. The stigma associated with mental health diagnoses often undermined perceived legitimacy and contributed to delays.

Legitimacy is continuously negotiated throughout the diagnostic pathway. It is shaped by social, moral and biomedical judgements. To promote early cancer diagnosis for patients with pre-existing conditions, clinicians must make legitimacy assessments explicit, reduce stigma especially around mental health and standardise triage processes.

Length-for-age z-scores (LAZ) and stunting prevalence (%LAZ

We simulated a synthetic cohort with a harmonically downward-shifting LAZ trajectory from birth to 24 months of age, with mean LAZs similar to the HBGDki pooled South Asian cohorts, and without any input parameters intended to differentially affect individuals’ growth across the height distribution or at different ages. We compared HBGDki empirical estimates of age interval-specific frequencies of incident stunting onset and stunting reversal with those from the synthetic cohort. Using synthetic cohorts, we examined how estimates of incident onset and reversal were affected by missing data, magnitude of the whole-population shift in the LAZ distribution and strength of the between-time-point correlation. We also compared the 3–24 month pattern of linear growth faltering expressed as age-related trajectories of average growth delay (chronological age minus height–age), mean LAZ or stunting prevalence.

Empirical estimates of age interval-specific incident stunting onset and stunting reversal in the HBGDki cohorts were similar to those observed in a synthetic cohort. Variability in LAZ threshold-crossing event rates is explained by starting LAZ, between-time-point correlation and the magnitude of the whole-population shift in the LAZ distribution. Incident stunting onset is also affected by missing data in preceding intervals. Stunting reversal occurs due to within-child variability (ie, imperfect between-time-point correlation) in the absence of any other phenomena that cause stunted children to become non-stunted at a later age. The linear growth faltering pattern based on growth delay differed from corresponding age-related trajectories of mean LAZ or stunting prevalence.

In longitudinal studies of linear growth faltering in LMICs, LAZ threshold-crossing indicators are byproducts of whole-population shifts in LAZ and within-child variability and should be interpreted accordingly. Reporting incident stunting onset and reversal rates, or analyses in which children are grouped by the timing of LAZ threshold-crossing events, may detract from efforts to understand when and why nearly all children in LMICs grow more slowly than expected for their age. Since mean LAZ and stunting prevalence are unsuitable for quantifying the rate and timing of population-average postnatal linear growth faltering, growth delay is recommended for consideration as a preferred metric.

Self-harm and suicide are common among prison inmates, but less is known about these phenomena in those with psychosis.

The aim of this study was to examine self-harm behaviour in New South Wales (NSW) prisons in Australia among inmates diagnosed with psychosis. This study also examined self-harm-related alerts applied by Corrective Services to assist staff with the management of the security and well-being of inmates.

A retrospective case-control data-linkage study was conducted using administrative data collections in NSW, Australia.

The study included all individuals diagnosed with psychosis and incarcerated between 2001 and 2020 in NSW as cases and an age and sex matched control group with no such diagnosis with a record of incarceration in the same time period.

The primary outcome measure was self-harm among the cases and controls. The secondary outcome measure was the application of alerts by Corrective Services in relation to self-harm incidents.

Multivariate regression analysis was used to examine predictors of self-harm in prison. Prisoners with psychosis (n=14 900) were more likely to self-harm than controls (n=2713), with 15.0% versus 3.6% engaging in self-harm (highest odds of self-harm observed in those with schizophrenia and related psychoses, aOR=4.84, 95% CI: 3.93 to 5.98). Those of Aboriginal heritage had an increased risk of self-harm (aOR=1.58, 95% CI: 1.43 to 1.75). Factors associated with a lower risk of self-harm were male sex and older age (≥25 years) at the time of their first incarceration. 35.6% of those released from prison with a prior psychosis diagnosis had at least one alert applied during incarceration compared with 10.1% of prisoners without a diagnosis of psychosis. Overall, 35 individuals with psychosis and 1 individual from the control group died while in prison between 2001 and 2020. 17 prison suicides were recorded from the study population; all occurred in the psychosis group.

Given the heightened risk of self-harm in those with histories of psychosis, consideration should be given to sharing mental health information between agencies to improve the care and management of this group during incarceration. Prison alerts may be a useful tool to help staff manage inmates’ well-being if used appropriately.

To quantify and describe the use of real-world data (RWD) in National Institute for Health and Care Excellence (NICE) oncology technology appraisal (TA) final appraisal determination documents.

A systematic literature review was conducted on pharmaceutical NICE oncology TAs published between April 2000 and March 2024 (covering financial years 2000/2001 to 2023/2024 inclusive) extracted on 22 August 2023 (2000/2001 - 2022/2023) and 8 August 2024 (2023/2024).

NICE TA final appraisal determination documents.

All pharmaceutical oncology TAs published between April 2000 and March 2024 (financial years 2000/2001 to 2023/2024) that did not go on to be terminated.

The data required for eligibility screening was extracted from an Excel file directly from the NICE website, where data related to each TA was extracted using an automated script derived from published sources. TAs were assessed based on prespecified review criteria covering whether an RWD submission was reported by the committee, and if so, which RWD sources were used, alongside the methods reported and any feedback from the committee regarding the use of RWD. Bias was not assessed as part of the study.

Of 310 TAs identified, 135 (48.0%) used RWD. A variety of RWD types were used, mostly from UK or US data sources. 47 TAs (34.8%) leveraged RWD from multiple sources. RWD was mostly used in comparisons of survival (41.5%), to inform utility values (26.7%) and to compare baseline characteristics (19.3%), with matched adjusted indirect comparisons (MAICs) and external control arms (ECAs), seen from 2015 and 2018, respectively. The committee expressed concerns around the RWD presented by the company in 53 TAs (39.2%), the most common being a lack of generalisability to the UK population and/or National Health Service practice and comprehensiveness of the RWD.

This study quantifies the increasing use of diverse RWD sources in NICE oncology TAs, as well as the shift towards more complex methods like MAICs and ECAs. The feedback of the NICE committee highlights key areas of improvement as the generalisability and maturity of the RWD presented.

This study analysed the clinical outcomes and healthcare costs associated with diabetic foot ulcer (DFU) within a tertiary healthcare centre in Singapore.

This is a retrospective, single-centre study. Patient data were extracted from the hospital’s electronic health system, including demographic, clinical and hospitalisation information. Hospitalisation costs were categorised into DFU-related and other hospitalisation costs. A one-way sensitivity analysis was performed to estimate the total healthcare costs associated with DFU.

Tertiary centre within a population suffering from a diabetic epidemic.

All patients aged 18 years or older who received DFU treatment between January 2019 and December 2023 at the Singapore General Hospital were included.

A total of 2857 DFU patients were included in the study. In-hospital mortality remained stable at 5%–6% annually. Among the cohort, 39.1% underwent minor amputations, 19.6% had major amputations and 9.0% experienced both minor and major amputations. The median length of stay for surgical patients ranged from 10 (IQR 4–24) to 13 days (IQR 6–31), compared with 4 (IQR 2–8) to 5 (IQR 3–9.5) days for non-surgical patients. Total costs per admission for patients with DFU-related surgery ranged from US$28 588.96 to US$34 204.77, while for those without surgery, costs ranged from US$6637.59 to US$7955.23. Total hospitalisation costs for DFU during the study period ranged from US$65.87 million to US$72.16 million. All figures were inflation adjusted to 2023 US dollars.

DFU poses a significant clinical and economic burden in Singapore. Understanding the costs associated with DFU is essential for resource allocation and planning in DFU management.

Type 2 diabetes mellitus (T2DM) and osteoarthritis (OA) are globally prevalent chronic diseases that affect millions of individuals in ageing populations. Hip and knee replacements are well established and effective treatments in patients suffering from end-stage OA. Understanding how T2DM influences the outcomes of these surgeries is important for optimising patient care and improving surgical results. This study aimed to explore the association of T2DM with reoperation (regardless of the reason), adverse events (AEs) and mortality after primary hip and knee replacement surgery.

Observational study based on prospectively collected registry data analysed retrospectively.

Data from several Swedish national quality registers and health data registers were used to create a study database. 109 938 and 80 897 primary hip and knee replacements due to OA, performed between 2008 and 2019 (hip) and 2009 and 2018 (knee), were included in the study.

The risk of complications, such as reoperation, AEs and mortality, was investigated by estimating HRs using Cox regression, and OR using logistic regression, unadjusted and adjusted for confounding factors, such as patient characteristics, socioeconomic status and comorbidities, and mediators, such as surgical factors.

Adjusted multivariable Cox-regression analysis showed no T2DM-associated risk of reoperation after hip or knee replacement, adjusted HR 1.10 (95% CI 0.99 to 1.23) and 1.09 (95% CI 0.96 to 1.24), respectively, while T2DM was associated with increased risk of death after hip and knee replacement, adjusted HR 1.40 (95% CI 1.34 to 1.47) and 1.38 (95% CI 1.31 to 1.45). Adjusted logistic regression analysis showed T2DM-associated increase of reoperation within 90 days (OR 1.23 (95% CI 1.05 to 1.43)) and increased mortality within 90 days (OR 1.42 (95% CI 1.01 to 1.95)) following hip replacement; however, this was not the case after knee replacement, OR 1.08 (95% CI 0.85 to 1.36) for reoperation and OR 1.29 (95% CI 0.84 to 1.94) for mortality. Several factors closely linked with T2DM, such as body-mass index and comorbidities, were identified as important when assessing risk of reoperation and mortality. Regarding AEs within 30 and 90 days, very slight but not statistically significant T2DM-associated increases were seen after either hip replacement, OR 1.01 (95% CI 0.91 to 1.11) and 1.07 (95% CI 0.98 to 1.16) or after knee replacement, OR 1.05 (95% CI 0.93 to 1.17) and 1.08 (95% CI 0.98 to 1.19).

The observed risk of reoperation suggests that T2DM alone was not a strong justification to advise against hip or knee replacement in individuals with T2DM deemed eligible for joint replacement. The T2DM-associated increased mortality after hip and knee replacement is challenging to interpret, as T2DM itself without undergoing hip or knee replacement surgery is associated with increased mortality.

This study examined the mental health literacy of perinatal healthcare professionals in the United Arab Emirates (UAE) and analysed how their knowledge, attitudes and confidence impact their clinical practices in addressing perinatal mental health disorders.

A qualitative study with a descriptive phenomenological design. Data were collected via semi-structured individual interviews and focus group discussions. The data were analysed inductively using Braun and Clarke’s six-step thematic analysis.

The study was conducted in Abu Dhabi, Dubai and Al Ain in the UAE. Participants were recruited from various healthcare facilities and professional educational events.

The participants consisted of perinatal healthcare professionals from seven disciplines, including lactation consultants, midwives, nurses, obstetricians, paediatricians, family medicine practitioners and psychiatrists/psychologists. All participants were required to be actively involved in providing care to perinatal patients and to have a minimum of one year of clinical experience. The study included three focus group discussions and 28 semistructured individual interviews, culminating in a sample of 43 participants for analysis.

Three key themes emerged: (1) Knowledge and awareness, highlighting variable understanding of perinatal mental health and reliance on instinct over formal screening; (2) Navigating professional roles and realities, showing empathy and willingness to support patients, yet role ambiguity, low confidence and societal stigma influence perinatal healthcare professionals’ responses and care practices and (3) Strengthening support systems and resources, where participants called for improved training, clear policies and psychosocial resources to overcome institutional and educational gaps and to enhance perinatal mental healthcare and patient outcomes.

The study reveals gaps in mental health literacy and institutional support that hinder the delivery of effective perinatal mental healthcare. Strengthening provider training, implementing standardised screening and referral pathways, and promoting culturally sensitive, multidisciplinary approaches are essential. Such interventions can enhance early detection and improve outcomes for mothers and infants. Further research should focus on developing and evaluating the efficacy of such interventions to enhance early detection and improve outcomes for mothers and infants.