To assess the prevalence of malnutrition risk, especially of undernutrition, among patients admitted to the Internal Medicine and Orthopaedics wards at Michele and Pietro Ferrero Hospital, Italy, using the Nutritional Risk Screening 2002 (NRS-2002) tool, administered by trained nursing staff, and to evaluate the adherence to related care interventions.
Cross-sectional study.
We included 248 adult patients, screened by trained nurses for nutritional risk within 48 h of admission using the NRS-2002 tool, which takes into account patients' Body Mass Index, recent weight loss, reduced dietary intake, and disease severity. Information on nursing interventions was also collected.
We identified 36 subjects at risk of malnutrition with NRS ≥ 3. Prevalence was higher in Internal Medicine, reflecting differences in patient characteristics and clinical complexity. Patients at risk were older, had longer hospital stays, and higher risks of falls and pressure sores. Nursing interventions such as proper meal selection, administration of hypercaloric-hyperproteic supplements, and completion of food diary were implemented in most cases, although adherence was not complete. Post-training questionnaire showed that, overall, nurses integrated nutritional screening into practice, but areas for improvement were identified.
Results confirmed the high prevalence of malnutrition risk in hospitalised patients, especially in Internal Medicine. Proper training and empowerment can enable nurses to effectively identify and manage patients at intermediate risk of malnutrition.
Nurses can play key roles in hospital nutritional care by facilitating early identification and appropriate management of patients at malnutrition risk.
Malnutrition is very common among inpatients. Trained and empowered nurses can perform nutritional screening at admission to identify and early manage patients at risk, thereby helping to prevent increased morbidity, mortality and healthcare costs.
STROBE guidelines.
None.
To explore patients' experiences of participation in surgical wound care and provide an in-depth understanding of their experiences with post-operative wound care during and post-hospitalisation.
A descriptive qualitative study.
Adult participants who had undergone surgery within 30 days were purposively selected from two surgical wards at Gold Coast University Hospital. Seventeen semi-structured phone interviews were conducted using a specifically developed and piloted interview guide. Textual data were analysed using inductive content analysis.
Three main categories were identified. The first category, ‘I didn't expect how distressing post-operative wound care would be; it's tougher than I thought,’ highlights the significant and unexpected physical and emotional challenges participants faced, which initially hindered their engagement. The second category highlights the impact of healthcare professional interactions on patient participation, ‘I want to be involved, but conflicting advice and dismissive behaviour discourage me.’ The third category, ‘With my family's help, wound care got easier as I tried, learned, and recovered,’ illustrates how family support facilitated participants' independence and engagement over time.
The spectrum of patient participation in surgical wound care is dynamic and impacted by environmental, physical and psychological factors. This research deepens understanding of patient participation by highlighting the importance of family support and a temporal perspective in patients' wound care journeys.
Findings showed participants were unprepared for surgical wound care, greatly influenced by healthcare provider communication and family support, and evolved in participation as time passed and their wounds healed. Additionally, participants valued intent just as significantly as their behaviours and regarded even minor involvement as totally participative. These insights can inform strategies to improve patient participation in surgical settings.
SRQR (Standards for Reporting Qualitative Research).
No patient was involved in this study.
Higher levels of individual health literacy have been associated with better health outcomes, greater medication adherence and improved self-management of chronic conditions. Hence, higher health literacy levels are expected to be indirectly associated with lower healthcare costs. The aim of this review is to identify and synthesise available studies on the relationship between individual health literacy and healthcare costs.
Systematic review with qualitative evidence synthesis.
MEDLINE, Scopus, Web of Science Core Collection and CINAHL were searched up to 7 March 2025.
We considered only studies that investigated and quantified the relationship between individual health literacy and healthcare costs sustained by individuals, insurance companies or health providers.
Article screening and data extraction were performed by two authors independently. We critically appraised the identified study by using the AXIS checklist and evaluated the methodology adopted for cost analysis. Finally, we performed a qualitative synthesis of the study results.
Of a total of 5801 articles identified, 23 studies met the inclusion criteria. Almost half of the studies were conducted in the USA and about one-third in European countries. The included studies showed fair average quality and great heterogeneity in health literacy measures and cost analyses. The analyses considered general medical, treatment-related, inpatient, outpatient and emergency costs, out-of-pocket expenses and financial hardship. Fifteen studies reported statistically significant results, estimating the association between health literacy and costs or evaluating the difference in costs incurred by different health literacy subgroups. All study results supported the hypothesised negative association between health literacy levels and healthcare costs.
Individual health literacy was found to be negatively associated with a range of healthcare costs, although the supporting evidence was not always robust. Interventions aimed at containing healthcare expenditure should consider this association, while further research is needed to define its nature.
The review has been registered in the PROSPERO International prospective register of systematic reviews (registration code CRD42023435502).
China has continued to improve tuberculosis (TB) control in the past decade; however, the sudden outbreak of COVID-19 hindered this progress. As a province with a large population and frequent international exchanges, Guangdong has been seriously affected by COVID-19. This study aimed to understand the effect of COVID-19 on TB detection in Guangdong based on the autoregressive integrated moving average (ARIMA) model.
Time-series study.
Guangdong, China.
We used the ARIMA model to quantify the effect of COVID-19 by comparing reported cases during the COVID-19 pandemic with predicted cases under a counterfactual scenario of no COVID-19 pandemic. After model evaluation, we chose ARIMA (0,1,2)(0,1,1)12 as the prediction model. We also highlighted that there were three emergency response periods in which the responses and public responses to COVID-19 varied.
During the pandemic period, the average annual TB notification rate was 57.95/100 000, which decreased by 27.97% compared with the pre-pandemic period. Although it decreased by 6.17% on average annually in the pre-pandemic period, it decreased by 14.92% in 2020 as compared with 2019, but only decreased by 0.34% in 2021 as compared with 2020. The results of the ARIMA model showed that the number of reported cases in 2020 decreased by 6.62% compared with that of the predicted cases, but this decreased by 0.42% only in 2021. The most seriously affected period was the second-level emergency response period in 2020, when the relative difference between reported and predicted cases reached the peak (–16.43%). The least affected period was the third-level emergency response period of 2021, the reported cases recovered and exceeded the predicted cases, with a gap of 0.77%.
TB detection in Guangdong had generally declined during the COVID-19 pandemic, which might be related to the movement restrictions, diverted resources and patients’ concerns. This decline would lead to the delay or even interruption of diagnosis and treatment, which would cause the regression of TB control. To improve TB detection, it is important for stakeholders to take consorted effort during public health emergencies.
by Fabian Standl, Lena Senger, Heribert Stich
BackgroundSex workers are often considered at elevated risk for sexually transmitted infections (STIs). This pilot study describes the socio‑epidemiological characteristics of registered sex workers in a rural German setting, estimates the prevalence of four STIs (HIV, hepatitis B [HBV], hepatitis C [HCV], and syphilis [lues]), compares these with the local population, and assesses HBV immunization coverage.
MethodsUnder §10 of the Prostitute Protection Act (ProstSchG), annual health consultations are mandatory; voluntary serologic testing is permitted under §19 of the Infection Protection Act. We conducted a retrospective observational monocentric pilot study using routine consultation records and voluntary serologic results from the Public Health Service (PHS) of Landshut (2017–2021). In total, 523 consultations were documented; 99 blood samples from 48 registered sex workers (2019–2021) were analyzed. Primary screening assays were followed by confirmatory tests when indicated. Crude point/period prevalences and 95% confidence intervals (95% CI) were calculated. HBV immunization was defined according to Standing Committee on Vaccination (STIKO) recommendations.
ResultsThe cohort was predominantly female (n = 47; 97.9%), mean age 34.8 ± 11.2 years; 85.3% (n = 41) had a migration background (n = 27; 56.3% from Eastern EU countries). No acute HIV, HBV, or HCV infection was detected. Evidence of past HBV infection (anti‑HBc) was found in n = 7 (14.6%; 95% CI: 6.8–26.5), past HCV in n = 1 (2.1%; 95% CI: 0.2–9.3). Syphilis serology was reactive in 12.5% (n = 6), with n = 2 (4.2%; 95% CI: 0.9–12.7) meeting criteria for treatment‑requiring infection. HBV vaccine‑induced immunity was documented in 43.8%; only 29.2% achieved titers ≥100 mIU/ml. Compared with regional surveillance data, the prevalence of acute notifiable STIs among sex workers was not increased.
ConclusionsIn this rural setting, acute notifiable STIs were uncommon among registered sex workers, while past HBV infection and suboptimal HBV immunization were frequent. Public health efforts should prioritize HBV vaccination and syphilis prevention or treatment, and expand low‑threshold, trusted services tailored to this workforce.
To evaluate the psychometric properties of the Hospital Survey on Patient Safety Culture (HSoPSC) version 2.0 in Ethiopian public hospitals.
A cross-sectional study.
Five public hospitals in Eastern Ethiopia.
Healthcare professionals (N=582).
An adapted and contextualised version of HSoPSC 2.0 was used to conduct structural validity using exploratory and confirmatory factor analyses (EFA and CFA). Convergent and discriminant validity were evaluated through item loadings and interfactor correlations, respectively. Reliability was measured using McDonald’s omega and Cronbach’s alpha.
CFA indicated a poor model fit for the original 10-factor, 32-item HSoPSC 2.0 across all statistical indices: relative chi-square (²/df=7.71), root mean square error of approximation (RMSEA=0.108), standardised root mean square residual (SRMR=0.088), comparative fit index (CFI=0.814) and Tucker-Lewis’s index (TLI=0.780). Consequently, a comprehensive EFA was conducted, which identified a revised model comprising 5-factor, 21-item. This model accounted for 62.8% of the total variance and demonstrated strong construct validity, with excellent fit indices (²/df=3.67, RMSEA=0.068, SRMR=0.034, CFI=0.969, TLI=0.945). Internal consistency, assessed via McDonald’s omega and Cronbach’s alpha, exceeded the acceptable threshold of 0.70 across all dimensions, except for Response to Error (0.66). The convergent and discriminant validity of the new model was confirmed, ensuring an accurate representation of the underlying constructs.
The original HSoPSC 2.0 with 10-factor, 32-item failed to demonstrate structural validity in the Ethiopian healthcare context. In contrast, a revised 5-factor, 21-item model showed strong validity and acceptable reliability. This adapted version provides a culturally and contextually relevant tool for assessing patient safety culture in Ethiopian healthcare settings.
by Juliane Tetzlaff, Fabian Tetzlaff, Marc Luy
BackgroundMany governments increased the retirement age in response to population ageing. Against this backdrop, it remains unclear whether the development in healthy life years can keep pace with the increase in working life years and whether people with lower socio-economic status are left behind. We investigated time trends in healthy life years and healthy working life years and how trends differ between educational groups in Germany.
MethodsTemporal trends in partial life expectancy between age 30 and 69 were assessed using data from the German Socio-Economic Panel (GSOEP, N=40,150) of three educational groups. Based on this, education-specific (Un)Healthy Life Expectancy ((U)HLE) and (Un)Healthy Working Life Expectancy ((U)HWLE) were calculated using the Sullivan method. Health is assessed on the basis of two health indicators: the physical and the mental score of health-related quality of life (p/mHRQoL). Both has been shown to be important indicators for working-age health.
ResultsWith respect to pHRQoL, HLE increased among men and women with higher educational attainment while it decreased in men with lower educational level. HWLE increased stronger in men and women with higher than with lower educational attainment. UHWLE increased strongest in persons with lower educational attainment. In terms of mHRQoL, HLE increased in all educational groups except for the group of women with lower educational attainment. UHLE decreased among men and women with middle and higher educational level. HWLE increased in all groups, with increases being strongest among higher educated individuals. UHLE increased in women with lower educational attainment but decreased in men and women with higher educational level.
DiscussionWe found polarising trends, with healthy life years and healthy working years developing less favourably among people with lower than with higher educational level. This applies to both the physical and mental component of HRQoL. The study shows that people with lower educational level are less able to keep pace with the prolonged working life from a health perspective and that more effective prevention is needed to stop the widening of health inequalities in working age.
The study aims to explore the experiences of Black Canadian parents following a preterm birth and their perspectives of being in the NICU.
A qualitative design guided by principles of community engagement was used to explore the experiences of Black Canadian parents.
Focus groups and in-depth interviews were conducted with 40 Black parents of preterm infants. A thematic analysis approach was used to organize the data into meaningful themes.
Five major themes were identified through the data analysis: encountering racism and discrimination in the NICU, bearing the emotional weight of staying in the NICU, enduring the feeling of bodily betrayal and guilt, grappling with the turmoil of uncertainty and seeking peer and mental health support programs.
This study provides in-depth understanding of the unique experiences of Black Canadian parents after a preterm birth and the challenges they face navigating the NICU.
Developing a targeted training program for health care providers is critical to address racism and discriminatory practices and enhance parents' sense of belonging in the NICU. Creating Black-focused peer support and accessible mental health care during and after the NICU is critical to address the gaps in programs and services and to promote effective coping.
Addressing racism and discriminatory practice requires urgent attention to promote equity within the NICU environment. Scaling up access to Black peer support and mental health programs will contribute to improving parental wellbeing in Canada and beyond.
This study was in partnership with the Canadian Premature Babies Foundation, our community collaborator.
To assess the effects of behaviourally informed short message service (SMS) reminders on demand for human papillomavirus (HPV) immunisation.
Individually randomised, five-group, controlled parallel trial.
A country-wide trial in Georgia.
55 176 girls aged 10–12, the entire population of unvaccinated girls of this age in the country, for whom there existed caregiver contact details.
Girls were randomised into five arms (four with n=11 035, with one n=11 036). Caregivers of the girls in four of the arms (treatment groups) were sent different versions of an SMS reminder (SMSR), reminding them that the girl was due to receive the HPV vaccine. The control group was sent no SMSR.
The primary outcome was a girl’s HPV vaccination status at the end of the trial.
Girls and their caregivers were blinded to group assignment.
The number of participants analysed in the four treatment groups was 10,784, 10,802, 10,794 and 10,820, with 10 828 analysed in the control group.
Each of the SMSRs was more effective than the control (no reminder) in encouraging HPV vaccination. Girls whose caregiver(s) were sent version 3 had 65% greater odds of receiving the vaccine relative to the control group (OR=1.65; 95% CI 1.38 to 1.97). Among girls whose caregivers received version 1, version 2 and version 4 of the SMS, the odds of receiving the HPV vaccine were respectively 42% (OR=1.42; 95% CI 1.18 to 1.70), 34% (OR=1.34; 95% CI 1.12 to 1.61) and 35% (OR=1.35; 95% CI 1.13 to 1.62) higher compared with the girls in the control arm.
We find a positive and statistically significant effect for each version of the SMSR, relative to the control condition.
by Dilara Tank, Bianca G. S. Schor, Lisa M. Trommelen, Judith A. F. Huirne, Iacer Calixto, Robert A. de Leeuw
PurposeTransvaginal ultrasound (TVUS) is pivotal for diagnosing reproductive pathologies in individuals assigned female at birth, often serving as the primary imaging method for gynecologic evaluation. Despite recent advancements in AI-driven segmentation, its application to gynecological ultrasound still needs further attention. Our study aims to bridge this gap by training and evaluating two state-of-the-art deep learning (DL) segmentation models on TVUS data.
Materials and methodsAn experienced gynecological expert manually segmented the uterus in our TVUS dataset of 124 patients with adenomyosis, comprising still images (n = 122), video screenshots (n = 472), and 3D volume screenshots (n = 452). Two popular DL segmentation models, U-Net and nnU-Net, were trained on the entire dataset, and each imaging type was trained separately. Optimization for U-Net included varying batch size, image resolution, pre-processing, and augmentation. Model performance was measured using the Dice score (DSC).
ResultsU-Net and nnU-Net had good mean segmentation performances on the TVUS uterus segmentation dataset (0.75 to 0.97 DSC). We observed that training on specific imaging types (still images, video screenshots, 3D volume screenshots) tended to yield better segmentation performance than training on the complete dataset for both models. Furthermore, nnU-Net outperformed the U-Net across all imaging types. Lastly, we report the best results using the U-Net model with limited pre-processing and augmentations.
ConclusionsTVUS datasets are well-suited for DL-based segmentation. nnU-Net training was faster and yielded higher segmentation performance; thus, it is recommended over manual U-Net tuning. We also recommend creating TVUS datasets that include only one imaging type and are as clutter-free as possible. The nnU-Net strongly benefited from being trained on 3D volume screenshots in our dataset, likely due to their lack of clutter. Further validation is needed to confirm the robustness of these models on TVUS datasets. Our code is available on https://github.com/dilaratank/UtiSeg.
Leishmaniases are a group of vector-borne diseases caused by parasites of the genus Leishmania, which are renowned for increasing global spread due to factors like climate change, globalisation, urbanisation and migration. Leishmaniasis is classified as a neglected tropical disease but is endemic in several areas of the Mediterranean Basin, including Italy, where Leishmania infantum is most involved as the parasite, phlebotomine sand fly as the vector and dog as the principal reservoir. Effective surveillance of communicable infectious diseases is a goal worldwide for organisations such as the WHO and for local and national governments but is an unfulfilled objective. Even in Italy and particularly in the region of Tuscany, despite mandatory reporting, significant gaps each year are identified between reported cases and hospital admissions. By estimating the underreporting of confirmed human leishmaniasis cases, this protocol aims to suggest actions to strengthen the current epidemiological surveillance system to enable timely and effective public health intervention in human and veterinary populations.
This retrospective multicentre study, conducted in the Central Tuscany Health District, the most populous area of the Tuscany region with approximately 1.6 million inhabitants, is based on the analysis of data collected from 2014 to 2024 using diagnostic laboratory, hospital and regional information system sources. The primary objective is to estimate the degree of underreporting of leishmaniasis in this area through the application of capture-recapture models. The secondary objective is to analyse the clinical and demographic characteristics of individuals diagnosed as confirmed leishmaniasis cases between January 2014 and December 2024, as well as to perform a geolocation analysis of the cases. The study includes the entire population, both adult and paediatric, of the Central Tuscany Health District who underwent laboratory testing for leishmaniasis (serological tests identifying the presence of antibodies; parasitological examination with evidence of amastigotes in aspirates, smears or biopsy sections; culture examination of aspirates, biopsies and/or peripheral blood positive for the presence of promastigotes; identification of Leishmania nucleic acid in aspirates, biopsies and/or peripheral blood samples via molecular diagnosis).
The study is being conducted in accordance with the protocol approved by the Ethics Committee of the Tuscany Region – Pediatrics Section, in November 2024. Ethics Committee opinion register number: 219/2024. Because the study uses only pseudonymised, routinely collected administrative and laboratory data with no direct patient contact or intervention, individual informed consent was not required, as confirmed by the Ethics Committee. Findings will be submitted to a peer-reviewed journal, presented at international conferences and presented at stakeholder workshops.
This integrative review aimed to describe the postoperative wound care practices and knowledge of nurses in acute care settings. Whittemore and Knafl's framework was used to identify and synthesise relevant studies. Full-text, primary articles published after 2000, focusing on postoperative wound care by nurses in hospital settings, were included. Quality appraisal was undertaken using the Mixed Methods Appraisal Tool (MMAT) for qualitative and quantitative studies and the Standards for QUality Improvement Reporting Excellence (SQUIRE) 2.0 for quality improvement (QI) studies. Five databases were searched (MEDLINE, Scopus, CINAHL, Embase and Web of Science) in August 2024. Of the 5329 studies, 36 articles were included. Inductive content analysis was used for data synthesis. Three categories were identified: Variation in using a holistic approach impacts optimal wound care practice, nurses' surgical wound care practices are shaped by individual factors, organisational support, and resource availability, and nurses' participation in surgical wound care is influenced by role clarity and multidisciplinary collaboration. In conclusion, this integrative review highlights that acute care nurses predominantly focused on technical dressing procedures with limited emphasis on comprehensive assessment, documentation, nutrition and patient education. Therefore, adopting a more holistic approach in surgical wound care could minimize practice variations among nurses.
Despite increasing proportions of underrepresented minority (URM) medical school graduates, their progression into surgical training and leadership remains disproportionately low. Barriers such as financial constraints, limited mentorship and implicit bias contribute to this disparity, creating a disconnect between the diversity of patient populations and those providing care. While interventions such as mentorship programmes and pipeline initiatives have been implemented, their overall effectiveness has not been systematically evaluated. The primary aim of this scoping review is to map the current landscape of interventions, programmes and policies designed to enhance access to surgical careers for URM learners.
Searches will be conducted on EMBASE, Web of Science and OVID MEDLINE. Three independent reviewers will screen references, extract data and perform analyses with disagreements adjudicated by a fourth reviewer. This review will include studies conducted across all levels of training: secondary (high school or secondary school), postsecondary (undergraduate, medical school) and postgraduate (residency, fellowship), with no geographical restrictions. The definition of URM will be accepted as reported within each individual study, allowing for variability in racial, ethnic, gender, socioeconomic or other criteria. The review will include any structured interventions, programmes or policies aimed at increasing URM representation in surgical education. Data on the nature, duration and target population of each intervention will be extracted. The primary outcome will be the reported impact of interventions on URM representation or participation in surgical education. Secondary outcomes will include characteristics of the study participants, definitions of URM status and any qualitative or quantitative evaluations of intervention effectiveness.
Research ethics approval is not required under University of Toronto policy. Study results will be reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. Results will be disseminated to relevant stakeholders at conference presentation(s) and submitted for publication in a peer-reviewed journal.
To explore how patients with thyroid cancer (TC) experienced and perceived post-traumatic growth (PTG) during diagnosis and thyroid-stimulating hormone suppression therapy (TSHST).
This is a descriptive qualitative study with individual semistructured WeChat interviews from March to May 2022. Data were analysed using qualitative thematic analysis.
Oncology surgery department in general hospitals in China.
A total of 13 patients with TC who had undergone TSHST after surgery were recruited through purposive maximum variation sampling and interviewed.
Five themes emerged that described the coping process and change of accepting cancer-related trauma: (1) stress and transition; (2) inner reconstruction and insights; (3) behavioural regulation and self-realisation; (4) assessment and linkage of growth resources; and (5) changing trend of growth. During the process of disease diagnosis and TSHST, the respondents used supportive growth resources to achieve inner reconstruction and insights, leading to behavioural regulation and self-realisation. These three conditions are mutually influential, ultimately determining their transformation from stress to positive inner growth.
The experiences of PTG among patients with TC varied during the diagnosis and treatment stages. Their PTG experiences are individually heterogeneous. Their somatic symptoms and psychological burdens can interplay with and influence their PTG experiences. Psychological interventions based on different positive psychological characteristics among patients with TC are essential to address patients’ disease-related trauma and help them achieve PTG.
Conventional treatments, like immunosuppressants for systemic lupus erythematosus (SLE), are associated with many side effects. Transcutaneous vagus nerve stimulation (tVNS) emerges as a promising adjunctive therapy, potentially offering a more benign therapeutic avenue for patients with SLE. The increased number of clinical trials, including randomised clinical trials, highlights the importance of a systematic review and meta-analysis to evaluate the efficacy and safety of tVNS in treating SLE. Consequently, the aim of this systematic review and meta-analysis protocol is to synthesise the available evidence to elucidate the efficacy and safety of tVNS for the treatment of SLE.
Databases include PubMed, Cochrane Library, Web of Science, Embase, Wanfang Database, China National Knowledge Infrastructure, VIP Database and Chinese BioMedical Literature Database. Data selection, extraction and quality assessment by two independent reviewers. Fatigue is the primary outcome, and secondary outcomes include pain, quality of life, negative emotions, adverse events and measures of SLE disease activity. We will use instruments appropriate for each study type to assess the risk of bias. The credibility of evidence will be evaluated using the grading of recommendation, assessment, development and evaluation system. For meta-analysis, we will use RevMan software to perform data synthesis (V.5.4.1). Besides, publication bias assessment, sensitivity, subgroup and meta-regression analyses will be conducted as appropriate.
All data used in our study will be extracted from published clinical trials and, therefore, no ethical approval is required. Study results will be disseminated through peer-reviewed journals and relevant academic conferences.
PROSPERO CRD42024525580.
This study aims at documenting the frequency of reported abuse, stigma and discrimination and exploring the perspectives for improving the quality of maternal-newborn care (QMNC) of migrant mothers’ reporting abuse, stigma or discrimination.
Mixed methods multicentre cross-sectional study.
All maternal facilities (tertiary and secondary levels of care, n=9) from Friuli-Venezia Giulia region, Northeast Italy, between November 2019 and January 2022 in Northeast Italy.
874 migrant and 3968 non-migrant women answering a validated WHO Standard-based questionnaire after birth.
Frequency of reported abuse, stigma and discrimination during facility-based childbirth was calculated and compared with those of non-migrant mothers. Thematic analysis was conducted on eight open questions, using WHO Standards as a framework for the analysis.
Among migrant women, 84 (9.6%) reported some type of abuse, stigma and discrimination, a frequency similar to non-migrant women (9.8%, p=0.880). The most frequently reported was verbal abuse (87.7%), followed by stigma and discrimination (15.1%). Most women (86.9%) provided at least one comment, with a frequency comparable to non-migrant women (p=0.076). Among a total of 327 comments, 104 (31.8%) were practical suggestions for improving QMNC. Experience of care was the domain with the highest frequency both of negative (64.9% of negative comments) and positive comments (51.7% of positive comments) and with the highest frequency of suggestions for improving QMNC (52.9% of suggestions). Overall, suggestions mainly focused on strengthening healthcare professionals’ communication skills, allowing companionship during childbirth, increasing healthcare professionals’ availability and timely support.
This study shows that both migrant and non-migrant mothers are exposed to abuse, stigma and discrimination during childbirth, and that both are willing to provide practical suggestions, which should be used for planning actions to improve QMNC.
There is limited evidence on how to effectively treat individuals from marginalised populations with dependence on amphetamine and/or methamphetamine (collectively referred to hereafter as amphetamine dependence). The disease burden is extremely high in this population, especially related to psychiatric comorbidities, cardiovascular complications, injection-related infections and poor social functioning. ATLAS4Dependence is a multi-centre randomised, placebo-controlled, double-blind trial that will investigate the effectiveness and safety of substitution treatment with dextroamphetamine compared with placebo in people with amphetamine dependence.
The trial will recruit 226 adult patients in several outpatient clinics in Norway.Inclusion criteria comprise individuals with amphetamine dependence, defined as use on three or more days per week during the past 28 days, who currently inject or have formerly injected drugs. This includes individuals both with and without comorbid opioid dependence, as well as those currently receiving or not receiving opioid agonist treatment. Participants will be randomly assigned 1:1 to receive either dextroamphetamine or placebo for 12 weeks. Flexible doses within the range of 30–120 mg daily will be provided based on individual assessments. The participants in both arms will be offered standard psychosocial and medical follow-up in accordance with current clinical practice. The endpoint assessments will be conducted at 12 weeks with weekly self-reports and safety assessments and a follow-up assessment at 52 weeks. The primary objective of the study is to assess the impact of 12 weeks daily prescribed oral dextroamphetamine versus placebo on the use of illicit amphetamines as well as on the total amount of amphetamines used (including both illicit and prescribed sources). Secondary outcomes are the differences between the groups at 12 weeks regarding psychological distress, symptoms of psychosis, quality of life, cardiovascular risk factors, injection-related infections, executive functioning, attention-deficit hyperactivity disorder-related symptoms, sleep, violence risk, fatigue, symptoms of craving and withdrawal, treatment retention, days of use of illicit amphetamines and use at 4 weeks and 8 weeks during the intervention period, use of other illicit substances and alcohol, as well as a cost-effectiveness analysis (using private economy, criminal activity and health service utilisation) and a qualitative approach to assess overall experiences with the study intervention. Analysis and reporting will follow the Consolidated Standards of Reporting Trials guidelines. All tests will be two-sided. Descriptive results and the estimated effectiveness will be presented with 95% CIs. The difference between the groups at the primary time point (at the end of the 12-week trial) will be assessed using 2 test (for use of illicit amphetamines measured by monthly urine tests) and Analysis of Covariance (ANCOVA) (for weekly self-reported total amount of amphetamines). Analyses for the primary endpoint will be undertaken on an intention-to-treat basis and reported on as such, but sensitivity analyses with per protocol analyses will also be presented.
The study is approved by European Medicines Agency, Clinical Trial Information System (CTIS). Written informed consent will be obtained from all patients. Study results will be published in international peer-reviewed medical journals.
CTIS 2023-510404-44-00.
Although lung cancer remains the leading cause of cancer deaths in the US, recent advances in early detection and treatment have led to improvements in survival. However, there is a considerable risk of recurrence or second primary lung cancer (SPLC) following curative-intent treatment in patients with early-stage non-small cell lung cancer (NSCLC). Professional societies recommend routine surveillance with CT to optimise the detection of potential recurrence and SPLC at a localised stage. However, no definitive evidence demonstrates the effect of imaging surveillance on survival in patients with NSCLC. To close these research gaps, the Advancing Precision Lung Cancer Surveillance and Outcomes in Diverse Populations (PLuS2) study will leverage real-world electronic health records (EHRs) data to evaluate surveillance outcomes among patients with and without guideline-adherent surveillance. The overarching goal of the PLuS2 study is to assess the long-term effectiveness of surveillance strategies in real-world settings.
PLuS2 is an observational study designed to assemble a cohort of patients with incident pathologically confirmed stage I/II/IIIA NSCLC who have completed curative-intent therapy. Patients undergoing imaging surveillance will be followed from 2012 to 2026 by linking EHRs with tumour registry data in the OneFlorida+ Clinical Research Consortium. Data will be consolidated into a unified repository to achieve three primary aims: (1) Examine the utilisation and determinants of CT imaging surveillance by race/ethnicity and socioeconomic status, (2) Compare clinical endpoints, including recurrence, SPLCs and survival of patients who undergo semiannual versus annual CT imaging and (3) Use the observational data in conjunction with validated microsimulation models to simulate imaging surveillance outcomes within the US population. To our knowledge, this study represents the first attempt to integrate real-world data and microsimulation models to assess the long-term impact and effectiveness of imaging surveillance strategies.
This study involves human participants and was approved by the University of Florida Institutional Review Board (IRB), University of Florida IRB 01, under approval number IRB202300782. The results will be disseminated through publications and presentations at national and international conferences. Safety considerations encompass ensuring the confidentiality of patient information. All disseminated data will be de-identified and summarised.
Multiple sclerosis (MS) is a chronic neurological condition that affects approximately 150 000 people in the UK and presents a significant healthcare burden, including the high costs of disease-modifying treatments (DMTs). DMTs have substantially reduced the risk of relapse and moderately reduced disability progression. Patients exhibit a wide range of responses to available DMTs. The Predicting Optimal INdividualised Treatment response in MS (POINT-MS) cohort was established to predict the individual treatment response by integrating comprehensive clinical phenotyping with imaging, serum and genetic biomarkers of disease activity and progression. Here, we present the baseline characteristics of the cohort and provide an overview of the study design, laying the groundwork for future analyses.
POINT-MS is a prospective, observational research cohort and biobank of 781 adult participants with a diagnosis of MS who consented to study enrolment on initiation of a DMT at the Queen Square MS Centre (National Hospital of Neurology and Neurosurgery, University College London Hospital NHS Trust, London) between 01/07/2019 and 31/07/2024. All patients were invited for clinical assessments, including the expanded disability status scale (EDSS) score, brief international cognitive assessment for MS and various patient-reported outcome measures (PROMs). They additionally underwent MRI at 3T, optical coherence tomography and blood tests (for genotyping and serum biomarkers quantification), at baseline (i.e., within 3 months from commencing a DMT), and between 6–12 (re-baseline), 18–24, 30–36, 42–48 and 54–60 months after DMT initiation.
748 participants provided baseline data. They were mostly female (68%) and White (75%) participants, with relapsing–remitting MS (94.3%), and with an average age of 40.8 (±10.9) years and a mean disease duration of 7.9 (±7.4) years since symptom onset. Despite low disability (median EDSS 2.0), cognitive impairment was observed in 40% of participants. Most patients (98.4%) had at least one comorbidity. At study entry, 59.2% were treatment naïve, and 83.2% initiated a high-efficacy DMT. Most patients (76.4%) were in either full- or part-time employment. PROMs indicated heterogeneous impairments in physical and mental health, with a greater psychological than physical impact and with low levels of fatigue. When baseline MRI scans were compared with previous scans (available in 668 (89%) patients; mean time since last scan 9±8 months), 26% and 8.5% of patients had at least one new brain or spinal cord lesion at study entry, respectively. Patients showed a median volume of brain lesions of 6.14 cm3, with significant variability among patients (CI 1.1 to 34.1). When brain tissue volumes z-scores were obtained using healthy subjects (N=113, (mean age 42.3 (± 11.8) years, 61.9% female)) from a local MRI database, patients showed a slight reduction in the volumes of the whole grey matter (–0.16 (–0.22 to –0.09)), driven by the deep grey matter (–0.47 (–0.55 to –0.40)), and of the whole white matter (–0.18 (–0.28 to –0.09)), but normal cortical grey matter volumes (0.10 (0.05 to 0.15)). The mean upper cervical spinal cord cross-sectional area (CSA), as measured from volumetric brain scans, was 62.3 (SD 7.5) mm2. When CSA z-scores were obtained from the same healthy subjects used for brain measures, patients showed a slight reduction in CSA (–0.15 (–0.24 to –0.10)).
Modelling with both standard statistics and machine learning approaches is currently planned to predict individualised treatment response by integrating all the demographic, socioeconomic, clinical data with imaging, genetic and serum biomarkers. The long-term output of this research is a stratification tool that will guide the selection of DMTs in clinical practice on the basis of the individual prognostic profile. We will complete long-term follow-up data in 4 years (January 2029). The biobank and MRI repository will be used for collaborative research on the mechanisms of disability in MS.