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Randomised controlled study investigating standard dose continuous renal replacement therapy (CRRT) versus low-dose CRRT in critically ill patients with acute kidney injury (AKI): study protocol for a prospective, randomised, controlled, international, mu

Por: Strauss · C. · Sadjadi · M. · von Groote · T. · Booke · H. · Schöne · L. M. · Hegner · C. · Wempe · C. · Meersch · M. · Gerss · J. · Bernard · A. · Haeberle · H. A. · Rosenberger · P. · Rahmel · T. · Unterberg · M. · Adamzik · M. · Arndt · C. · Wulf · H. · Romagnoli · S. · Bonizzoli · M.
Introduction

The only supportive therapy for patients with severe acute kidney injury (AKI), a common complication among the critically ill, is dialysis. Based on the literature and current guidelines, continuous renal replacement therapy (CRRT) with a total effluent dose of 20–25 mL/kg/hour and adjustments to ensure such dose is delivered despite down time (eg, due to surgical procedures) is recommended. However, experimental and clinical studies suggest that azotaemia, which can be induced by lowering the effluent dose, may accelerate renal recovery. This clinical study investigates whether a lower effluent dose (10–15 mL/kg/hour) for a maximum of 7 days or until successful (>24 hours) liberation of CRRT in critically ill patients with a dialysis-dependent AKI accelerates renal recovery and reduces time on CRRT compared with guideline-directed standard dose (25–30 mL/kg/hour).

Methods and analysis

The Ketzerei trial is an international, multicentre randomised, controlled trial, designed to investigate if a lower effluent dose (10–15 mL/kg/hour) accelerates renal recovery and reduces the time on CRRT compared with the guideline directed standard effluent dose (25–30 mL/kg/hour). The study aims to enrol 150 critically ill patients with a dialysis-dependent AKI. Eligible patients will be randomised to receive either a standard effluent dose (control group, 25–30 mL/kg/hour) or lower effluent dose (interventional group, 10–15 mL/kg/hour). The primary endpoint is the number of days free from CRRT and alive (from randomisation through day 28). Key secondary endpoints include the number of (serious) adverse events due to potential uremia, the duration of RRT and intensive care unit survival.

Ethics and dissemination

The Ketzerei trial has been approved by the Ethics Committee of the Chamber of Physicians Westfalen-Lippe (2023–343 f-s), the University of Muenster and subsequently by the corresponding Ethics Committee of the participating sites. Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and will guide patient care and further research.

Trial registration number

clinicaltrials.gov (NCT06021288).

Assessing anxiety in adolescents with autism spectrum disorder (ADORA): developing a health equity protocol for non-invasive biomarkers

Por: Yarger · H. A. · Redcay · E. · Herrington · J. · Kerns · C. M. · Thomas · S. B.
Introduction

Identifying anxiety disorders in autistic youth can be challenging due to the unique presentation of anxiety symptoms in autistic youth and the difficulties youth may have reporting on their own anxiety symptoms. These challenges underscore the need for objective and reliable measures. Understanding whether autonomic activity is associated with the presence of anxiety may lead to its use as an objective anxiety assessment tool in individuals who may otherwise struggle to communicate their feelings of anxiety. Most published studies examining autonomic activity and anxiety in autistic individuals lack information regarding racial demographic information, and those that do are predominantly composed of White individuals. These findings highlight the critical need for future research that includes more diverse samples and uses consistent, ecologically valid methods to examine the relation between anxiety and autonomic activity in autistic populations. This study aims to recruit a large sample of racially diverse adolescents to evaluate whether atypical autonomic activity serves as a biomarker of anxiety in autistic and non-autistic youth. This manuscript outlines the recruitment strategies for this study protocol, providing a framework for understanding the interplay between physiological, psychological and contextual factors including self-identified race in anxiety among autistic and non-autistic adolescents.

Methods and analysis

Autistic (n=80) and non-autistic (n=80) adolescents aged 11–14 years and their caregivers will be invited to participate in the current study. Autism diagnosis will be confirmed by gold-standard assessments. All participants will complete an in-person visit assessing their child’s cognitive abilities and trait-level anxiety and mental health symptoms, learn how to wear a non-invasive heart rate band that will collect ECG and respiration data, complete a 5-minute in-lab baseline of autonomic activity and enroll in experience sampling. Next, participants will complete three 5-minute baselines of autonomic activity at home, followed by 5 days of wearing the heart rate band for 5 hours per day, overlapping with ecological momentary assessment of their mood. Primary outcome measures include trait-level parent and self-reports of anxiety, real-time self-reports of anxiety captured through ecological momentary assessment, and both baseline and in-the-moment heart rate variability.

Ethics and dissemination

The study protocol has been approved by the University of Maryland’s Institutional Review Board. Results will be disseminated through peer-reviewed publications and conferences. Deidentified data from participants who consent to have their data shared with other researchers will be uploaded to the National Data Archive Collection C5316.

Longitudinal investigation of psychological outcomes associated with screen use in Danish preschool children: study protocol for The Digital Child

Por: Nygaard · M. · Olsen · M. F. · Thomsen · M. M. W. · Hadi · N. H. A. · Trans · K. L. · Horwood · S. · Flensborg-Madsen · T.
Introduction

Despite an increasing use of screens among preschool children and evidence suggesting potential adverse effects, there is a paucity of longitudinal research that aims to disentangle the multifaceted components of screen use and their unique associations with development. We present a protocol for a large-scale national longitudinal study with repeated measurements in Danish preschool children, with the aim of investigating the cross-sectional and cross-lagged longitudinal associations between screen use and psychological outcomes.

Methods and analysis

The Digital Child Study is a national prospective observational cohort of Danish preschool children. Baseline parent-report data collection commenced in 2024 via online questionnaires, and in total will include three time points over 1 year: baseline (age 4 years), and follow-ups at 6 and 12 months (ages 4.5 and 5 years). Participants were divided into two waves based on birth dates, starting in March and September 2024. Recruitment targeted parents and primary caregivers of all Danish children born between specific dates in 2020. Of 30 235 children whose parents were sent invitations, baseline questionnaire data were available for 11 690 (39%).

Children’s screen use was measured by detailed information of amount, content and timing of children’s screen use, and the broader context, incorporating parental mediation strategies, attitudes, motivations and practices. Cognitive and socioemotional developmental outcomes were measured using validated tools such as the Strengths and Difficulties Questionnaire, the Nordic Five-to-Fifteen parent questionnaire and the Behaviour Rating Inventory of Executive Function—Preschool Version. Questionnaire data will be linked to national social and health registries to enable long-term follow-up. Statistical analyses will include longitudinal modelling to explore associations between screen use and developmental outcomes, with sensitivity analyses for robustness. The study’s large sample size provides high statistical power to detect meaningful effects.

Ethics and dissemination

The study adheres to ethical research guidelines, ensuring voluntary participation, confidentiality and compliance with data protection laws, with approvals from relevant authorities. Findings will be disseminated through peer-reviewed publications, conferences and plain-language summaries to engage stakeholders and the broader community.

Mixed-methods study protocol to develop and pilot a Competency Assessment Tool to support therapists in the care of patients with blunt CHest trauma (CATCh study)

Por: Battle · C. · Barnett · J. · Driscoll · T. · Hutchings · H. A. · ONeill · C. · Toghill · H. · Whelan · R. · Baker · E.
Introduction

Competency assessment tools are well-recognised as a method to achieve a standardised level of practice for a group of healthcare professionals with similar characteristics. The aim of this study is to develop and pilot a new competency assessment tool to support therapists caring for patients with blunt chest trauma from prehospital care through to long-term follow-up following hospital discharge.

Methods and analysis

A mixed-methods study will be undertaken, with three distinct phases: (1) an integrative narrative review to examine the literature regarding therapist competencies; (2) focus groups with patients, therapists and key stakeholders to explore opinions regarding important aspects of care (phases I and II will inform the content of the tool), followed by final tool development by an international expert panel; and (3) a multicentre pilot study using questionnaires and elicitation interviews, in which final tool acceptability to therapists will be tested. The total sample size will be between 40 and 50 participants for the focus groups. For the final tool development work, a panel of 10 international experts will be identified, with a subgroup of 3–5 experts who will be recruited to confirm content validity. We will pilot the tool at five health boards in Wales, aiming for 10 therapists from each. Elicitation interviews will be undertaken with a smaller sample size of between 15 and 20 therapists. A mixed qualitative and quantitative data analysis approach will be used.

Ethics and dissemination

Proportionate ethics approval has been granted (South Yorkshire Research Ethics Committee, reference number: 24/YH/0231). We will publish the work in an open-access peer-reviewed journal to ensure equitable access and present at relevant conferences. Webinars will be used to achieve a wide audience. The results will be shared with the research participants via an infographic which will be designed and developed with the public research partners.

Trial registration number

Integrative review is registered at the Open Science Framework: https://doi.org/10.17605/OSF.IO/CEXNR

Blended palliative and survivorship care intervention (POISE) for patients with metastatic oncogene-driven non-small cell lung cancer: study protocol for a pilot randomised controlled trial

Por: Richard · H. A. · Sarathy · R. · Rabideau · D. J. · Feldman · J. · Cartagena · L. · Patel · H. · Sequist · L. V. · Park · E. · Jackson · V. · Greer · J. A. · Temel · J. S. · Petrillo · L. A.
Introduction

Patients with metastatic oncogene-driven non-small cell lung cancer (NSCLC) are experiencing longer and uncertain trajectories of life-limiting illness due to advances in precision medicine. These advanced cancer survivors face new challenges related to living with uncertainty and desire more support to maximize their health and quality of life. Therefore, we developed a population-specific, blended palliative and survivorship care intervention to address the supportive care needs of patients recently diagnosed with advanced lung cancer and who are receiving targeted therapy for NSCLC with EGFR, ALK, ROS1 or RET driver mutations.

Methods and analysis

This study is a single-site, non-blinded pilot randomised controlled trial of an intervention for patients with metastatic oncogene-driven NSCLC, Patient-centred, Optimal Integration of Survivorship and palliative carE (POISE) versus usual care. POISE consists of a brief series of structured visits with a trained palliative care clinician to address coping with uncertainty, increase prognostic awareness and promote healthy lifestyle behaviours. We will recruit 60 patients from the Massachusetts General Hospital Cancer Center. Patients will be randomised into a 1:1 ratio to the intervention arm or the usual care arm. Patients randomised to the intervention arm will complete four 60 min virtual or in-person visits with a palliative care physician. The usual care arm will receive standard oncology care. Patients in both arms will complete survey assessments at enrolment, 12 weeks and 20 weeks after enrolment, and patients in the intervention group will complete an exit interview. The primary outcome measure of this trial is feasibility, which will be defined by ≥60% enrolment among eligible patients, ≥70% completion of all sessions for participants in the intervention arm and ≥70% completion of all surveys for all study participants. Exploratory outcomes include acceptability, emotional coping with prognosis, self-efficacy for chronic disease management, prognostic awareness, quality of life, anxiety, depression, intolerance of uncertainty and documentation of goals and values discussions in the electronic health record.

Ethics and dissemination

This study was approved by the Dana-Farber/Harvard Cancer Center’s institutional review board (protocol 20-722). The protocol is reported in accordance with the Standard Protocol Items: Recommendations for Interventional Trials guidelines, and the study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials.

Trial registration number

NCT04900935.

What factors influence nutrition-related information-seeking behaviour among pregnant women attending antenatal care at public hospitals in Bahir Dar City, northwest Ethiopia: a cross-sectional study

Por: Bitacha · G. K. · Asemahagn · M. A. · Mekonnen · Z. A. · Chekol · T. M. · Ahmed · M. H. · Meshesha · N. A. · Guadie · H. A. · Dube · G. N.
Objective

This study aimed to assess the proportion of nutrition-related information-seeking behaviour and its associated factors among pregnant women attending antenatal care at public hospitals in Bahir Dar City, northwest Ethiopia, 2023.

Method

A cross-sectional quantitative supplemented with qualitative study design was conducted from March to April 2023 among 406 pregnant women. Pre-tested structured interviewer-administered and semistructured open-ended questionnaires were used to collect quantitative and qualitative data, respectively. Data were collected using the Kobo toolbox, and SPSS V.25 was used for analysis. Descriptive statistics were used to describe study subjects, and multivariate logistic regression analysis was employed to investigate the associated factors. The strength of associations was described using the OR with the corresponding 95% CI.

Result

The study included 406 pregnant mothers with a median age of 28 with an IQR of 8 and 212 (52.2%) from rural settings. Of the total respondents, 173 (42.6%; 95% CI 37.7 to 47.6) of pregnant mothers were nutrition-related information seekers. Educational status, residence, monthly income and nutrition information literacy were significantly associated with nutrition-related information-seeking behaviour.

Conclusion

The proportion of nutrition information seeking among pregnant mothers in Bahir Dar City public hospitals was low. Lower educational status, low nutrition information literacy level, being from a rural residence and low monthly income are significantly associated factors.

Recommendation

Awareness creation for pregnant mothers from rural areas and with low educational status and improving nutrition information literacy of pregnant mothers are important activities to improve their nutrition information-seeking behaviour.

Prevalence of adolescent dual tobacco use and its associated factors: findings from a cross-sectional study

Por: Razali · M. F. · Riyadzi · M. R. · Abd Hamid · H. A. · Wan-Fei · K. · Yusoff · U. N.
Objective

To determine the prevalence and its associated factors of dual tobacco use among Malaysian adolescents in developing effective public health strategies.

Design

Cross-sectional study.

Setting

This study analysed data from the National Health and Morbidity Survey (NHMS) 2022: Adolescent Health Survey (AHS), a nationwide cross-sectional survey conducted among secondary school students across Malaysia.

Participants

This cross-sectional study used data from the NHMS 2022: AHS, which included a representative national sample of Malaysian adolescents between the ages of 13 and 17. Using a two-stage stratified sampling approach, this study included participation from 33 523 adolescents from 240 schools nationwide.

Primary and secondary outcome measures

The primary outcome was the prevalence of dual tobacco use among Malaysian school-going adolescents aged 13–17, defined as self-reported concurrent use of conventional cigarettes and e-cigarettes in the past 30 days. Secondary outcomes included the factors associated with dual tobacco use, such as sociodemographic characteristics, dual tobacco use behaviour, marital status of parents, tobacco use of parent or guardian, supervision, connectedness, bonding and respect for privacy of parent or guardian, along with peer support and truancy. A complex sample analysis was performed using SPSS V.27.0, maintaining a 95% CI and multiple logistic regression was applied.

Results

Out of 33 380 Malaysian adolescents surveyed, 1728 (5.5%; 95% CI: 4.88% to 6.28%) reported dual tobacco use. The prevalence was significantly higher among males (9.7%; 95% CI: 8.54% to 10.98%) compared with females (1.4%; 95% CI: 1.15% to 1.70%) and highest among 17 years (8.6%; 95% CI: 7.05% to 10.41%), with a decreasing trend in younger age groups. Predominant vapers constituted the largest proportion (9.9%, 95% CI: 8.66% to 10.13%) among adolescents who reported dual tobacco use, followed by predominant smokers (6.2%, 95% CI: 5.53% to 7.06%), dual daily users (4.5%, 95% CI: 3.18% to 5.64%) and non-daily dual users (3.9%, 95% CI: 2.79% to 4.39%). Dual tobacco use was more prevalent among adolescents whose parents or guardians used tobacco (8.1%; 95% CI: 7.10% to 9.20%). Multiple logistic regression analysis suggested that significant predictors of dual tobacco use included older age (adjusted OR (AOR) for 17 years: 2.92; 95% CI: 2.19 to 3.89), male sex (AOR: 8.53; 95% CI: 6.78 to 10.74), ‘others’ ethnicity (AOR: 1.82; 95% CI: 1.40 to 2.35), predominant vapers (AOR 2.65, 95% CI: 1.96 to 2.72), separated or widowed parental status (AOR: 1.69; 95% CI: 1.42 to 2.02), parental or guardian tobacco use (AOR: 2.47; 95% CI: 2.08 to 2.94), lack of bonding (AOR: 1.79; 95% CI: 1.49 to 2.14), lack of privacy respect (AOR: 1.53; 95% CI: 1.29 to 1.81), lack of peer support (AOR: 1.65; 95% CI: 1.39 to 1.96) and truancy (AOR: 1.81; 95% CI: 1.55 to 2.10).

Conclusions

This study highlights a concerning prevalence of dual tobacco use (5.5%) among Malaysian adolescents, which is notably higher than the current prevalence of exclusive cigarette smoking (6.2%) and closely approaches that of e-cigarette use (14.9%). Compared with previous national surveys and international benchmarks, the prevalence of dual use among Malaysian youth appears to be rising and represents a significant public health concern. These findings underscore the urgent need for targeted prevention and control strategies addressing both conventional and emerging tobacco products in this population.

Trends in educational inequality in healthy life expectancy in Denmark between 2010 and 2021: a population-based study

Por: Jensen · H. A. R. · Davidsen · M. · Bronnum-Hansen · H. · Eliasen · M. H. · Christensen · A. I.
Objectives

For several decades, mortality has decreased more rapidly among individuals with a higher socioeconomic position than among those with a lower position. This widening social inequality gap has increasingly been recognised as an important aspect of public health research and policies. The objective of this study was to examine trends in educational inequality in healthy life expectancy (HLE) in Denmark between 2010 and 2021 at the age of 30 years.

Design

The study is a population-based study based on register data on longest attained education, standard life tables and self-reported health information from nationwide health surveys.

Setting

The study is conducted among the general adult population in Denmark.

Participants

Participants include respondents from the Danish National Health Survey and the Danish Health and Morbidity Survey in 2010, 2013, 2017 and 2021 aged ≥30 years.

Primary and secondary outcome measures

Expected lifetime in good self-rated health, with no long-standing illness and with no activity limitations was estimated by Sullivan’s method, and educational inequality was expressed by the Slope Index of Inequality.

Results

Between 2010 and 2021, educational inequality in HLE increased among both men and women for long-standing illness (5-year trend: +1.1 and +1.2 years) and activity limitations (+2.4 and +2.6 years) but remained stable among men (+0.1 year) and decreased among women (–0.3 year) for self-rated health. For the latter two indicators, the inequality gap narrowed after 2017.

Conclusion

Trends in educational inequality in HLE in Denmark 2010–2021 vary by health indicator. Steadily widening gaps were demonstrated for long-standing illness, while narrowing gaps were seen after 2017 for activity limitations and self-rated health. Future studies are encouraged to explore potential health risk behaviours that may explain or modify these inequality trends.

Unlocking insights: exploring mammography beliefs among Teshie community mothers - a qualitative exploratory descriptive study

Por: Osei · E. A. · Watson-Quartey · L. · Kappiah · J. B. · Attafuah · P. Y. A. · Odonkor · R. · Toure · H. A. · Bressey · N. S. · Sarpong · C.
Background

Breast cancer is a global concern, especially for women of African descent, with rising cases in Ghana. While awareness and diagnostic screening have improved, studies in Ghana and many African countries have prioritised breast self-examinations, with limited focus on mammography.

Objective

Our study explores beliefs and attitudes towards mammography screening among mothers at Teshie Community in Ghana.

Methods

The study methodology was qualitative and an exploratory design was used. Convenience sampling was used to select 30 participants until saturation was reached. Indepth, one-on-one interviews were conducted with a semistructured interview guide with probes until saturation was reached. Then data were audiotaped audiotaped, transcribed and coded. Content analysis was done to generate themes and subthemes.

Findings

Most participants, 93%, had not undergone mammography screening. Only two individuals (7%) had experienced mammography screening. The study identified two major themes: beliefs and perceptions regarding mammography, and attitudes towards mammography screening. Participants generally displayed limited knowledge of mammography screening, along with mixed attitudes and varying degrees of motivation. Notably, many participants enjoyed strong spousal support for mammography screening.

Conclusion

It was recommended that nurses should create awareness of mammography to increase the knowledge of women and the general population about mammography, as this is believed to increase the uptake of mammography screening.

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