BMJ Open最新文献

Objective: To characterise diagnostic pathways for patients with melanoma in routine practice and compare patient, disease and diagnostic interval (DI) characteristics across pathways.

Design: Descriptive cross-sectional study using administrative health data.

Setting: Population-based study in Ontario, Canada.

Participants: Patients with melanoma diagnosed from 2007 to 2019.

Main outcome measures: We used latent class cluster analysis to create clusters of patients with similar diagnostic experiences to characterise diagnostic pathways in routine practice. Indicator variables characterised the patient's keratinocyte carcinoma and dermatologist history, presentation pattern, procedure types, number of visits and procedures, and the activity on the diagnosis date. χ² tests and Pearson residuals were used. We characterised clusters by the lengths of their DI, primary care subinterval and specialist care subinterval.

Results: There were 33 371 patients diagnosed with melanoma from 2007 to 2019. We identified four diagnostic pathways: 'primary care only' (n=6107), 'referred to specialist with immediate action' (n=8987), 'multiple visits and procedures in specialist care' (n=11 893) and 'specialist care only' (n=6384). Patient, disease and DI characteristics varied across pathways. Pathway types varied regionally. A higher proportion in the 'primary care only' pathway lived in rural areas whereas a higher proportion in the 'referred to specialist for immediate action' and the 'specialist care only' pathways lived in major urban centres. Across pathways, the median DI varied from 1 to 67 days, the median primary care subinterval varied from 1 to 30 days and the median specialist care subinterval varied from 1 to 25 days. Patients in the 'primary care only' pathway experienced the shortest DIs, and patients in the 'multiple visits and procedures in specialist care' pathway experienced the longest DIs.

Conclusions and relevance: We identified four melanoma diagnostic pathways. The shortest DI, the 'primary care only' pathway, highlights the important role of primary care and the need to reduce the wait for specialists. Diagnostic processes varied across geographical locations. Future research should address reasons for these differences, including whether they are associated with inefficient or inappropriate care.

Objectives: To evaluate the effect of delivery hospital busyness on the postnatal condition and the perinatal mortality among small preterm infants born at ≤32+0 gestational weeks.

Design: The daily delivery volume distribution is defined as lowest 10% ('quiet') and highest 10% ('busy') delivery-volume days, and days between (80%) as optimal delivery-volume days. We analysed differences in the incidence of selected adverse outcomes between quiet and busy days compared with optimal delivery-volume days by logistic regression followed by crude (ORs) and adjusted ORs (aORs) with 99% CIs.

Setting: A population-based cohort study based on prospectively collected real-world data from five university hospitals and 21 non-tertiary-level delivery hospitals in Finland, 2006‒2016.

Participants: 4323 small preterm infants.

Primary outcome measures: Umbilical cord pH ≤7.05, Apgar score 0-3 points at the age of 1 min, Apgar score 0-3 points at age 5 min, birth asphyxia (International Classification of Diseases-10 code), resuscitation with intubation.

Secondary outcome measures: Perinatal mortality comprising stillbirths and early neonatal deaths (<7 days).

Results: Busy days (busy vs optimal) showed no correlation with the primary birth-related outcomes. However, in the university hospitals, quiet days were associated with 80% lower odds of asphyxia (aOR 0.20, 99% CI 0.08 to 0.48) and 47% lower odds of resuscitation (aOR 0.53, 99% CI 0.39 to 0.72) compared with their incidence on optimal days.In university hospitals, the odds of early neonatal mortality among small preterm infants on busy days were twofold (aOR 2.08, 99% CI 1.26 to 3.45) than on optimal days. In the non-tertiary hospitals, however, this difference was statistically non-significant (aOR 0.68, 99% CI 0.19 to 2.45).

Conclusions: In the tertiary university delivery hospitals, busyness was associated with a twofold increase in early neonatal mortality among small preterm infants, whereas infants' condition at birth on busy days was comparable to their condition on optimal days. Neonatal capacity in tertiary units during busy days may be critical under stress.

Objective: Quantify insulin glargine prices following the market introduction of biosimilars. Examine price levels and price changes for originator and biosimilars, by country.

Methods: Retrospective quantitative analysis using insulin glargine pricing data, both of the originator product and its biosimilars. Segmented regression analysis using a dual-model approach: pooled and country-specific.

Setting: 28 European countries using data from the European Medicine Price Database for the period 2013-2023.

Main outcome measures: Price variations between countries were analysed to assess trends and correlations before and after biosimilar market entry.

Results: In the 28 countries studied, cost of insulin glargine underwent a median 21.6% decrease overall in the last decade (p<0.001). In 2022, the median price was €9.0 for the originator (first to market) Lantus (IQR €8.1-€10.4), €8.9 for the biosimilar Abasaglar (IQR €7.6-€10.1) and €7.0 for the biosimilar Semglee (median €7.0; IQR €6.8-€7.5). The originator price was higher than biosimilars (p=0.009). Biosimilar market entry was associated with an overall significant price reduction of the originator, both immediately after entry (p<0.001) and in the long-term postentry (p<0.001). No significant correlation was observed between the price of insulin and the countries' economic indicators.

Conclusion: This is the first study to show the price trend of insulin glargine and its correlation with the introduction of biosimilars, in Europe. A significant price reduction of the originator was observed after biosimilars entered the market. The median cost of biosimilars was lower than the originator, although with substantial differences between individual countries and producers.

Objectives: To explore barriers and facilitators to behaviour change in older people with mild frailty.

Design: Qualitative study.

Setting: Community-dwelling older people living with mild frailty.

Participants: 64 older people with mild frailty, workers delivering the service and stakeholders.

Methods: Semistructured interviews were conducted between July 2022 and May 2023 with participants in a randomised controlled trial ('HomeHealth') of a 6-month, home-based, personalised goal setting intervention, based around the Capability-Opportunity-Motivation-Behaviour model. We purposively sampled older participants receiving the service (n=49), workers delivering it (n=7) and stakeholders supporting its delivery (n=8). Interviews explored participation experiences, including engagement, perceived progress and impact. Transcripts were analysed using thematic analysis.

Results: Key themes included frailty symptoms and adapting/compensating for these, self-efficacy and beliefs about capacity or need for change, familiarity with goal-setting processes and health-related knowledge, accessibility of services and outdoor environments, and enabling social support. Participants were empowered to change behaviours with support, where personalised meaningful goals were set. These were maintained where they led to a tangible outcome and had increased self-efficacy; however, new health challenges and lack of intrinsic motivation could be barriers.

Conclusions: Regular and continued empathic person-centred support helps empower mildly frail people who are motivated to change their behaviour. Identifying those willing and able to identify their need for change may be key to maximise service use impact.

Trial registration number: ISRCTN54268283.

Objectives: To provide an overview of research, policies and programmes related to the sexual and reproductive health (SRH) needs of adolescents and youth (AY) in South Sudan in order to identify the gaps and potential areas of focus for researchers, policymakers and local and global SRH actors.

Design: Systematic scoping review following the Joanna Briggs Institute criteria for evidence synthesis.

Data sources: Medline, Embase and Global Health were searched for articles dated between 9 July 2011 and 13 July 2023. A grey literature search was conducted using Google search engine and on the websites of key stakeholders.

Eligibility criteria for selecting studies: We included all types of studies, policies, reports and programmes that pertained to any aspect of the SRH AY (ages 10-35) in South Sudan.

Data extraction and synthesis: All articles were screened by the first author using the predetermined eligibility criteria. A secondary review was conducted on all selected articles to ensure alignment with criteria. Data were extracted from all eligible articles using an established data extraction tool. The authors identified overarching themes from the extracted data and results were synthesised based on those themes.

Results: We screened 728 articles, resulting in 52 articles included in the review (19 peer-reviewed, 33 grey literature). Results were mapped across South Sudan and synthesised by key AYSRH thematic areas. The results were largely focused on the experiences of adolescent girls and young women and the sociocultural norms and economic challenges that contribute to their lack of access to SRH services and increased risk of experiencing various forms of gender-based violence. Vulnerable populations were excluded from research, policies and programmes, including very young adolescents, LGBTQ youth and youth with disabilities.

Conclusions: Quality research has been done on AYSRH in South Sudan; however, there are many key areas that have not been addressed such as maternal mortality and morbidities, safe abortion and tailored interventions for specific subgroups. While some policies and programmes were identified that address AYSRH, robust programme evaluation processes or evidence of follow-through or implementation of government strategies are lacking.

Objective: This study examined real-world treatment patterns and outcomes in patients with melanoma brain metastasis (MBM) treated with first-line immunotherapy consisting of nivolumab plus ipilimumab or anti-programmed death-1 (PD-1) monotherapy (nivolumab or pembrolizumab) or targeted therapy consisting of BRAF/MEK inhibitors.

Design: Retrospective chart review study.

Setting: Academic medical centres, community hospitals and private practice offices.

Participants: Included patients diagnosed with melanoma with brain metastasis in the USA.

Outcome measures: The statistical analysis was descriptive in nature. Overall survival (OS) and progression-free survival (PFS) were estimated using the Kaplan-Meier method and compared between treatments in a univariate Cox proportional hazards model.

Results: In total, 472 patients with MBM who received first-line nivolumab plus ipilimumab (n=246), anti-PD-1 monotherapy (n=112) or BRAF/MEK inhibitors (n=114) were identified. Patients receiving nivolumab plus ipilimumab, compared with patients receiving anti-PD-1 monotherapy or BRAF/MEK inhibitors, had favourable baseline prognostic factors, such as younger age, fewer or smaller brain metastases, better Eastern Cooperative Oncology Group performance status and less frequently elevated lactate dehydrogenase. Median follow-up times were 15.4 months (range 0.1 to 37.0), 13.3 months (range 0.3 to 36.6) and 13.9 months (range 1.9 to 36.5), respectively. Numerically longer OS was observed with nivolumab plus ipilimumab versus anti-PD-1 monotherapy (HR 0.47, 95% CI 0.34 to 0.67) or BRAF/MEK inhibitors (HR 0.72, 95% CI 0.50 to 1.04) and numerically longer PFS was observed with nivolumab plus ipilimumab versus anti-PD-1 monotherapy (HR 0.74, 95% CI 0.53 to 1.02) or BRAF/MEK inhibitors (HR 0.82, 95% CI 0.60 to 1.12). With nivolumab plus ipilimumab, anti-PD-1 monotherapy and BRAF/MEK inhibitors, 1-year OS rates were 79%, 60% and 72%, respectively; 1-year PFS rates were 68%, 58% and 59%.

Conclusions: In this real-world study, first-line nivolumab plus ipilimumab appeared to provide benefit versus anti-PD-1 monotherapy and BRAF/MEK inhibitors in patients with MBM, consistent with pivotal trial data. However, the observed benefit may have been due to confounding and selection bias, given that patients receiving nivolumab plus ipilimumab had favourable baseline prognostic factors compared with patients receiving anti-PD-1 monotherapy or BRAF/MEK inhibitors.

Objectives: To assess the association between depression and suicide attempt (SA) by age and region.

Design: Cross-sectional study.

Setting: First Affiliated Hospital of Wannan Medical College from January 2021 to January 2022.

Participants: Hospitalised patients.

Primary outcome measures: SA was the primary outcome and data on SA was obtained from the electronic medical records of hospitalised patients.

Methods and analysis: In this study, data on inpatients of the First Affiliated Hospital of Wannan Medical College from January 2021 to January 2022 were extracted from the medical record system using the convenience sampling method. According to the exclusion criteria, 7593 eligible research subjects were obtained. Logistic regression analysis was used to assess the association between depression and SA, combining age and region. Subgroup analyses were carried out to assess the relationship between age, region and SA in depressed patients, after excluding non-depressed patients, and to inspect the interaction of age and region. Finally, further comparisons of the disparities in suicide patterns among different age groups and regional groups were made.

Results: Among 7593 patients (3630 males), 655 (8.6%) patients with SA were observed. We found that depression was significantly associated with SA by age and region (all p<0.05). Specifically, depressed juveniles and adults had a higher risk of SA compared with non-depressed adults, and ORs (95% CIs) were 2.62 (1.59 to 4.30) and 1.67 (1.30 to 2.13), respectively. Furthermore, rural individuals with depression, urban individuals without depression and urban individuals with depression had a higher risk of SA compared with rural participants without depression, and ORs (95% CIs) were 1.60 (1.22 to 2.12), 1.29 (1.04 to 1.61) and 2.53 (1.83 to 3.49), respectively. In subgroup analyses, we further found that depression was strongly associated with SA in juveniles (OR 2.84, 95% CI 1.19 to 6.76, p=0.018) and urban patients (OR 1.67, 95% CI 1.15 to 2.40, p=0.006). Notably, the predominant methods of suicide among individuals with depression were the utilisation of sleeping pills or antidepressants.

Conclusion: Our study found individuals with depression are at higher risk of SA, especially juveniles and urban individuals. Effective integration of mental health and urban-rural services could mitigate the risk of suicide and contribute to better outcomes.

Objectives: Population ageing and the rise in chronic diseases place continual stress on healthcare systems. Scarce resources often impede equitable access to healthcare, particularly in rural areas, resulting in prolonged waiting times and heightened risks of morbidity and mortality. Telemedicine has emerged as a promising solution, offering remote and equitable care that could potentially bridge access gaps and enhance health outcomes. This systematic review aims to quantitatively examine the impact of telemedicine implementation on waiting times, defined as the time passed from the booking of a visit for an outpatient to the administration of the service.

Design: A systematic review was conducted using studies on telemedicine interventions that specifically addressed waiting times. Bias assessment was performed with three tools: ROBINS-I ("Risk of Bias In Non-Randomized Studies of Interventions"), AXIS ("Appraisal tool for Cross-Sectional Studies") and RoB-2 ("Risk of Bias-2"). A weighted mean approach was used to synthesise results, with medians synthesised using a median approach.

Data sources: Articles in English were retrieved from the PubMed and Scopus databases.

Eligibility criteria: Studies were excluded if they did not specifically address waiting times related to telemedicine interventions. Only studies that considered waiting times defined as the time passed from the booking of a visit for an outpatient to the administration of the service and any telemedicine intervention were included.

Data extraction and synthesis: A total of 53 records were included, encompassing 270 388 patients in both the experimental and control groups. The weighted mean reduction in waiting times was calculated, and bias was assessed. No record was evaluated to be at high risk of bias, with 69.8% of studies evaluated at low risk and 26.4% at moderate risk (3.8% were surveys). Results were synthesised using a weighted mean approach for studies reporting means, and a median approach for studies reporting medians.

Results: Overall, a weighted mean reduction of 25.4 days in waiting times was observed. Focusing on clinical specialties (n=114 042), the weighted mean reduction amounted to 34.7 days, while in surgical patients (n=156 346), telemedicine was associated with a weighted mean of 17.3 days saved.

Conclusions: The implementation of telemedicine solutions may significantly improve waiting times, potentially leading to more efficient and equitable healthcare systems.

Prospero registration number: CRD42023490822.

Introduction: Weight restoration is a primary goal in anorexia nervosa (AN) treatment. Recent studies suggest that addressing physical activity urges in patients with AN is a promising target to facilitate weight restoration. This trial will evaluate the feasibility of a virtual reality (VR)-based intervention as an add-on treatment to psychotherapy to improve activity urges and, consequently, initial treatment responses on core outcomes as targeted per AN treatment guidelines.

Methods and analysis: This single-centre feasibility trial adopts the single-blind, two-arm design and outcome measures of an intended full-scale randomised controlled trial (RCT) in order to establish that all necessary trial components work together as intended. It will evaluate feasibility as the primary endpoint and compare changes in ratings of the urge to be active between patients with AN randomly assigned to receiving VR intervention sessions and patients with AN in a control procedure. The feasibility of the full-scale RCT will depend on whether patients (1) will evaluate the experience as acceptable, (2) tolerate VR side effects and (3) will adhere to the intended intervention schedule. We define a set of three-tiered, formal progression criteria and employ a 'traffic light system' demarcating go (green), amend (amber) and stop (red) signals for advancing to the full-scale RCT.

Ethics and dissemination: The study was approved by the ethics committee of the Ruhr University Bochum's Medical Faculty at Campus East-Westphalia (AZ 2024-1296, 9 December 2024). Patients have to provide written consent before taking part in the study. The findings will be published with open access.

Trial registration number: DRKS00035681, German Clinical Trials Register.