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Enhancing communication with bereaved relatives about emergency and critical care trials (ENHANCE): a mixed-methods study

Por: Doughty · H. · Deja · E. · Young · B. · Welters · I. · Shepherd · V. · Milosevic · S. · OHara · K. · Carman · J. · Sankar · V. · Thomas-Jones · E. · Euden · J. · Woolfall · K.
Objectives

Clinical research in emergency and critical care is vital, but recruitment and consent are complex. Research may be conducted without prior consent when patients are critically ill, and interventions are time critical. Some patients may die before research participation can be discussed with relatives, leaving the bereaved unaware of their involvement. This study explored potential communication strategies for informing bereaved relatives when a patient has died following enrolment into an emergency or critical care study without prior consent.

Design and setting

A mixed-methods study using a telephone survey and semi-structured interviews conducted simultaneously. The survey was conducted within a National Health Service Trust in North West England with relatives of deceased study participants. Semi-structured interviews were conducted with bereaved relatives and research and clinical staff across the UK, and medical examiner (ME)/ME officers based in England and Wales. Quantitative data were analysed descriptively, and qualitative data were analysed using reflexive thematic analysis. Data were synthesised using a constant comparison approach.

Participants

11 bereaved relatives completed the survey. 53 individuals (21 research and clinical staff, 18 relatives and 14 MEs/officers) participated in semi-structured interviews.

Results

Although many trials do not include a process for notifying bereaved relatives about research participation, most relatives valued the opportunity to learn about their family member’s participation, emphasising the importance of transparency and trust. However, some raised concerns over the potential burden of automatic disclosure by the ME service. Offering bereaved relatives the option to receive sensitively worded information about research involvement at an appropriate time, soon after death, was recommended.

Conclusion

Bereaved relatives should have the choice to be informed about research participation without prior consent. Our findings support the need for transparent and sensitive communication and will contribute to future guidance for the design and conduct of adult emergency and critical care studies.

COPD Management in Primary Care: Underutilisation of Nursing Consultations

ABSTRACT

Objective

To describe the clinical profile, comorbidity burden, follow-up and healthcare utilisation in patients labelled as having Chronic Obstructive Pulmonary Disease (COPD) in Primary Care (PC) nursing consultations.

Design

Real-world data COPD, retrospective, observational study using routinely collected data in electronic health records (EHR). This study adheres to the STROBE reporting guidelines for cross-sectional studies.

Location

Three Primary Care centres in Catalonia, Spain, belong to the Catalan Health Service.

Participants

All patients aged ≥ 15 years with a recorded diagnosis of COPD in their EHR, excluding institutionalised individuals and those deceased before study onset. Final sample: 474 patients (105 women, 369 men; mean age 70 years) from a reference population of 28,000 individuals.

Main Measurements

Data included socio-demographics, smoking/alcohol, mMRC dyspnea, inhaled therapy/adherence, spirometry, comorbidities, Adjusted Morbidity Groups (GMA), active COPD care plans and 12-month healthcare use.

Results

EHR showed a high rate of missing data in follow-up variables (inhaler adherence 28.5%; dyspnea 17%–20%). Despite that, all participants were ‘labelled’ as COPD, most of them lacked spirometric confirmation. Active smoking was highly prevalent (52.3% women, 45.0% men). Hypertension, obesity and osteoarthritis were the most common comorbidities; anxiety, depression, osteoporosis and thyroid disorders were more frequent in women. Higher GMA complexity correlated with more Primary Care visits, especially nursing consultations, particularly in patients with cardiovascular disease and diabetes (p < 0.001) for 12 months follow-up. No significant differences between groups were found in urgent or hospital care use.

Conclusions

EHR-labelled COPD patients with cardiometabolic comorbidity received more structured nursing follow-up and more annual visits than without. Improving EHR recording, integrating spirometry with the EHR, and prioritising high-complexity profiles could enhance monitoring, treatment optimisation and equity—nursing consultations are a key lever.

Patient or Public Contribution

No patients or members of the public were directly engaged in the study design or data analysis. Nevertheless, the research was motivated by patient needs and aims to improve healthcare services.

School-to-work transition: The role of life satisfaction, risk perception, and resilience in youth career decision-making

by Petar Stanimirović, Tea Borozan, Katarina Petrović, Dragan Bjelica, Zorica Mitrović, Marko Mihić, Dejan Petrović, Anđelija Đorđević Tomić

Young people often face uncertainty during the transition from education to work, along with high unemployment and job dissatisfaction, which is addressed in the EU Youth Strategy, highlighting the need for better career support. This study aimed to identify main factors influencing youth career decisions and to develop a decision-making model. Five core constructs were defined through literature review: Dealing with Uncertainty, Risk Preference, Adaptability and Resilience, Education and Support, and Life Satisfaction. Data were collected from 673 engineering students. Regression analysis was used to test the proposed model and hypotheses, while Mann-Whitney and Kruskal-Wallis tests examined group differences. The developed model accounts for 46.2% (R² = 0.462) of the variability in students’ career choices. Adaptability and resilience emerged as the most influential factor (β = 0.557). Certain differences, for specific constructs, were also observed in relation to different groups of family income, gender and extracurricular activity engagement. The model supports more informed career decisions and provides insights that may help improve career guidance and educational policy. The findings also may contribute to bridging theory and practice in career development research. The study is limited by its sample, which included only engineering students from the Republic of Serbia, potentially restricting the generalizability of the results.

Incidence and predictors of mortality among TB-HIV co-infected individuals on anti-tuberculosis and anti-retroviral dual therapy in Northwest Ethiopia: A retrospective cohort study

by Abebe Fenta, Tebelay Dilnessa, Destaw Kebede, Mekuriaw Belayneh, Zigale Hibstu Teffera, Bewket Mesganaw, Adane Adugna, Wubetu Yihunie Belay, Habtamu Belew, Desalegn Abebaw, Bantayehu Addis Tegegne, Zelalem Dejazmach, Fassikaw Kebede, Gashaw Azanaw Amare

Background

Co-infection with the human immunodeficiency virus (HIV) and tuberculosis (TB) is a primary cause of death and morbidity. The rate of morbidity and death from TB-HIV is still Ethiopia’s top health issue.

Objective

This study aimed to assess the incidence and predictors of mortality among TB-HIV co-infected individuals on anti-TB and anti-retroviral dual Therapy at Debre Markos Comprehensive Specialized Hospital, Northwest Ethiopia.

Methods

A retrospective cohort study was conducted at the Debre Markos Comprehensive Specialized Hospital among 436 TB-HIV co-infected individuals. A computer-generated random sampling technique was used to select patient charts registered from September 1st, 2011, and August 31st, 2020. Epi-Data version 3.1 was used for data entry, and STATA version 13 was used for the analysis. The Kaplan-Meier survival curve was applied to estimate the cumulative survival time of the TB-HIV patients. Log-rank tests were utilized to compare the survival time across various categories of explanatory variables. Bi-variable and multivariable Cox proportional hazard models were fitted to find predictors of TB-HIV mortality.

Results

The mortality rate of TB-HIV co-infected individuals was 15.6%, with a median survival time of 42 months. Being male (Adjusted hazard Ratio (AHR)1.914;95%CI: 1.022–3.584), having CD4 count  Conclusion and recommendation

The mortality rate among TB-HIV co-infected patients at Debre Markos Comprehensive Specialized Hospital was high. Being male gender, having a CD4 count below 50 cells/mm³, being ambulatory and bedridden, having low baseline weight, and having low hemoglobin were the important predictors of mortality. To reduce mortality, it is crucial to focus on the early identification and management of high-risk patients, particularly those with low CD4 counts, poor functional status, and low hemoglobin. Strengthening integrated TB and HIV care services is recommended to improve patient survival outcomes.

NuPOWER (Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis): protocol for an open-label, single-arm, multicentre study

Por: Srivastava · A. · Kanny · A. · Langer · F. · Kubicek-Hofmann · C. · Alvarez Roman · M. T. · Nunez Vazquez · R. · Boban · A. · Dejanova-Ilijevska · V. · Miljic · P. · Garcia · J. · Halimeh · S. · Drillaud · N. · Valentin · J.-B. · Mancuso · M. E. · Castaman · G. · Santoro · R. C. · Leht
Introduction

Despite the known haemostatic action of emicizumab (Hemlibra) in haemophilia A patients, its role in the prevention and control of bleeding in high-demand haemostatic situations, such as major surgery, remains to be determined. Patients receiving regular emicizumab prophylaxis often require concomitant factor VIII (FVIII) therapy during major surgery to prevent uncontrolled bleeding and to promote postoperative healing. However, there are limited prospective surgical data relating to concomitant FVIII and emicizumab use. Simoctocog alfa (Nuwiq) is a B-domain deleted recombinant FVIII produced in a human cell line without chemical modification or protein fusion with proven efficacy as surgical prophylaxis in adult and paediatric patients. The Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis (NuPOWER) study aims to examine perioperative efficacy and safety of simoctocog alfa in haemophilia A patients on emicizumab prophylaxis undergoing major surgery.

Methods and analysis

NuPOWER is a prospective, open-label, single-arm, multicentre study that will be conducted at approximately 15 centres worldwide. Up to 28 male patients ≥12 years with severe haemophilia A and no FVIII inhibitors will be recruited. All patients must be receiving regular emicizumab prophylaxis and scheduled to undergo a major surgical procedure during which concomitant simoctocog alfa will be administered. The primary endpoint is the overall haemostatic efficacy of simoctocog alfa, adjudicated by an independent data monitoring committee using a pre-defined algorithm, and will consider intraoperative and postoperative efficacy assessments by the surgeon and investigator, respectively. Secondary endpoints include intraoperative haemostatic efficacy, postoperative haemostatic efficacy, number of allogeneic blood products transfused, perioperative FVIII plasma levels (as measured by FVIII activity) and thrombin generation, and safety parameters. In the era of non-factor therapy, NuPOWER will generate valuable prospective data on concomitant use of simoctocog alfa and emicizumab prophylaxis in patients with severe haemophilia A undergoing major surgery.

Ethics and dissemination

Ethical approval has been received from institutional review boards/independent ethics committees, and the study will be conducted in compliance with the Declaration of Helsinki. This work will be disseminated by publication of peer-reviewed manuscripts and presentations at scientific meetings.

Trial registration number

CT EU 2022-502060-21-00; NCT05935358.

Time trend and geographical distribution of major depressive disorder in Iran, 1990 to 2021: results from the Global Burden of Disease Study

Objective

Major depressive disorder (MDD) is a disabling disease and is recognised as a serious, public health concern. In this study, we aimed to determine the burden and trends of MDD in Iran.

Design and participants

Secondary data from the Global Burden of Disease study were used to analyse the time trend and geographical distribution of age-standardised rate incidence and disability-adjusted life years (DALYs) of MDD from 1990 to 2021 by sex and province, in Iran. Join point regression and ArcGIS software were used for these estimations.

Main outcomes and measures

Incidence and DALYs.

Results

The trend analysis from 1990 to 2021 generally showed an increasing trend of incidence and DALYs. The highest annual percent change (APC) for incidence (6.594 95% UI: 3.727, 9.473) and DALYs (6.396 95% UI: 3.552, 9.286) of MDD in Iran was observed from 2019 to 2021 segment. Also, the geographical distribution analysis showed that the highest average annual percent change (AAPC) for incidence and DALYs of MDD in both sexes was, respectively, in Kurdistan province (0.774; [95% UI: 0.619, 0.976] and Yazd province (0.760; [95% UI: 0.601, 0.918]). Finally, the highest incidence and DALYs for MDD in 2021 were in Kerman and Fars provinces and the lowest in East Azarbayejan, Lorestan, Hamedan, Chahar Mahal and Bakhtiari, Golestan and Khorasan-e-Razavi provinces.

Conclusion

The findings of this study indicate an increasing trend in the burden of MDD in Iran and show the necessity of creating national policies and preventive and therapeutic measures for mental health disorders in the population.

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