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Patient perspectives on the usability and content validity of the assessment of burden of chronic conditions tool for post-COVID in the Netherlands: a qualitative study

Background

Post-COVID syndrome manifests with a diverse array of symptoms for which no standard care plan currently exists. Many questions were raised by patients, which underscored the need for a validated patient-reported outcome measure (PROM). Therefore, a post-COVID module was developed to be included in the Assessment of Burden of Chronic Conditions (ABCC-) tool. The ABCC-tool evaluates and visualises the perceived physical, emotional and social burden of one or multiple chronic disease(s) using a balloon diagram and aims to facilitate person-centred care and structured discussions between patients and healthcare professionals. This study explores the patients’ perspective on the content of the ABCC-tool for post-COVID and the tool’s usability in a home-based setting.

Methods

All patients who completed the ABCC-tool for post-COVID were invited for an online semi-structured interview. We selected post-COVID patients who had used the tool in the past three months. Interviews were audio recorded and analysed using a thematic approach with Atlas.ti version 23.

Results

Nineteen post-COVID patients (10 males, mean age 56) were interviewed between May and August 2024. The tool was regarded as user-friendly, and patients indicated they would use the tool again in the future. Patients valued the tool’s broad range of topics, some of which are often overlooked in standard healthcare consultations. The tool was comprehensible and relevant according to all patients. The balloon diagram was easy to understand, but a legend explaining the colours of the balloons was preferred. Other suggestions for improvement included adding open-text fields and periodic reminders to increase usability and adding long-term data.

Conclusions

The ABCC-tool is a promising instrument for post-COVID patients, offering a structured way to monitor and communicate experienced burden in addition to standard healthcare consultations. Refinements addressing usability and comprehensiveness are recommended to facilitate its integration into clinical practices.

Effects of glucagon-like peptide-1 analogues on hard binary outcomes for patients at increased risk of cardiovascular events: a protocol for a systematic review with network meta-analysis and Trial Sequential Analysis

Por: Sillassen · C. D. B. · Faltermeier · P. · Petersen · J. J. · Kamp · C. B. · Grand · J. · Dominguez · H. · Frolich · A. · Gaede · P. H. · Gluud · C. · Mathiesen · O. · Jakobsen · J. C.
Background

Cardiovascular diseases, overweight, type 2 diabetes and chronic kidney disease increase the risk of cardiovascular events.

Glucagon-like peptide-1 analogues are recommended by the European Society of Cardiology and the American College of Cardiology to lower the risk of death and progression of cardiovascular disease in patients with cardiovascular disease and type 2 diabetes. Semaglutide, tirzepatide and liraglutide are approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of type 2 diabetes mellitus and overweight. CagriSema is currently not approved, but several phase III trials are ongoing.

No previous systematic review has investigated the effects of semaglutide, tirzepatide, CagriSema and liraglutide, which may not be disease-specific, on hard binary outcomes for all trial populations at increased risk of cardiovascular events.

Methods and analyses

We will conduct a systematic review and search major medical databases (Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, Latin American and Caribbean Health Sciences Literature, Science Citation Index Expanded, Conference Proceedings Citation Index—Science) and clinical trial registries from their inception and onwards to identify relevant randomised trials. We expect to perform the literature search in December 2025. Two review authors will independently extract data and assess the risk of bias. We will include randomised trials assessing the effects of semaglutide, tirzepatide, CagriSema and/or liraglutide in participants with an increased risk of cardiovascular events. The primary outcome will be all-cause mortality. Secondary outcomes will be myocardial infarction, stroke and all-cause hospitalisation. Data will be synthesised by aggregate data meta-analyses, Trial Sequential Analyses and network meta-analysis, risk of bias will be assessed with Cochrane Risk of Bias tool V. 2, and the certainty of the evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations and the Confidence in Network Meta-Analysis approach.

Ethics and dissemination

This protocol does not present any results. Findings of this systematic review will be published in international peer-reviewed scientific journals.

PROSPERO registration number

CRD42024623312.

Exposome project for health and occupational research night shift cohort (EPHOR-NIGHT): a unique resource to advance research on night shift work and chronic disease

Por: Harding · B. N. · Castano-Vinyals · G. · Broberg · K. · Albin · M. · Laurell · C. · Garde · A. H. · Nabe-Nielsen · K. · Fiehn · A. E. S. · van der Grinten · T. · Peters · S. · Vermeulen · R. C. H. · Gosh · M. · Loh · M. · Pronk · A. · Kogevinas · M.
Purpose

The EPHOR-NIGHT cohort was established to investigate how night shift work influences biological pathways and chronic disease risk using a comprehensive working-life exposome approach, focusing on cardiometabolic, mental health, cognitive and biological ageing outcomes.

Participant

The cohort includes 937 workers aged 20–65 years (88% female), primarily from the healthcare sector (96%) in Spain, Sweden, Denmark and the Netherlands. Participants were categorised as permanent day (39%), permanent night (35%) or rotating/other shift workers (26%). Data collection included questionnaires, daily ecological momentary assessments, wearable sensors tracking light, physical activity, heart rate and environmental exposures and biological samples (blood collected once and saliva collected during five points across the day), with harmonised protocols across countries.

Findings to date

From the 937 participants contributing data to the cohort, 708 had complete information from questionnaires, sensors and blood and saliva, with subsets undergoing advanced biological analyses, including genomics, targeted and genome-wide DNA methylation, telomere length and mtDNA copy number, metabolomics, transcriptomics, proteomics, hormone profiling and inflammatory biomarkers and blood metals. Many reported prevalent chronic conditions, including anxiety (27%), depression (18%) and metabolic disturbances. Night shift and rotating shift workers had greater exposure to long shifts and more scheduled rest days compared with day workers. Sleep duration and quality were poorest among permanent night shift workers.

Future plans

A 2-year follow-up was completed in June 2025, including the collection of additional biomarker data, psychosocial work environment data and data related to female sexual and reproductive health. Findings from the EPHOR-NIGHT study aim to inform prevention strategies and occupational health policies. Data will be made available to support broader research efforts on shift work and health.

Evaluating pain and neurological function with high frequency 10 kHz spinal cord stimulation in the treatment of painful diabetic neuropathy: design of a multicentre, randomised controlled trial (PDN-Sensory)

Por: Pop-Busui · R. · Petersen · E. A. · Levy · B. L. · Tesfaye · S. · Armstrong · D. G. · Grunberger · G. · Boulton · A. J. · Bharara · M. · Edgar · D. · Azalde · R. P. · Caraway · D.
Introduction

Current pharmacological treatment options for painful diabetic neuropathy (PDN) often fail to provide adequate pain relief. However, in the recent SENZA-PDN study, high-frequency 10 kHz spinal cord stimulation (SCS) demonstrated significant long-term improvements in lower limb pain and health-related quality of life (HRQoL) in a PDN population. Furthermore, more than half of 10 kHz SCS recipients showed improved sensory function based on non-blinded clinical assessments in post hoc analysis. We report the design of the PDN-Sensory study, which aims to evaluate changes in pain and neurological function with 10 kHz SCS in the treatment of PDN. The study will include objective measures of neurological function, including the modified Toronto Clinical Neuropathy Score (mTCNS) and intraepidermal nerve fibre density (IENFD).

Methods and analysis

This multicentre, prospective, randomised controlled trial will compare conventional medical management (CMM) with 10 kHz SCS+CMM in individuals with diabetes and chronic, intractable lower limb pain due to PDN. Participants will be randomised 1:1 to CMM alone or 10 kHz SCS+CMM, with optional crossover at 6 months. The primary outcome is the proportion of participants at 6 months achieving ≥50% pain relief from baseline. The key secondary endpoint is the proportion of participants at 6 months with a reduction in mTCNS of ≥3 points from baseline (excluding changes in foot pain). Additional endpoints at 6 and 12 months include changes from baseline in mTCNS, IENFD, 7-day averaged pain score, pain-related interference, HRQoL, sleep, psychological outcomes, functional status and metabolic parameters.

Ethics and dissemination

The study protocol received central approval from the Western Institutional Review Board (IRB #20230954). Local IRB approval will be required before initiation of the study at each participating clinical site. The study complies with Good Clinical Practice guidelines (ISO 14155), the Declaration of Helsinki, and all applicable national, federal and local regulatory requirements. Dissemination plans include presentations at national and international conferences and publication in a peer-reviewed journal with open access.

Trial registration number

NCT05777317.

Sub-chronic exposure to crude acetylene results in the development of deleterious cardio metabolic changes in <i>Sprague Dawley</i> rats

by Caroline Gatwiri Gitonga, Charles Githinji, Boniface Chege, Frederick Bukachi, Peter Waweru

Objective

Calcium carbide-derived acetylene is widely used as an artificial fruit ripening agent despite its potential health risks. This study aimed to investigate the effects of sub-chronic exposure to crude acetylene on cardiometabolic parameters using a rodent model.

Methods

Twenty-four male Sprague Dawley rats were randomized into four groups: control (no exposure) and three test groups exposed to 58,000 ppm crude acetylene for 10, 30, or 60 minutes daily over 42 days. Body weight, fasting blood glucose, oral glucose tolerance, hepatic triglyceride levels, adipose tissue mass, liver enzyme activity, and oxidative stress markers were assessed. Histopathological analysis of liver tissue was also conducted.

Results

Acetylene exposure did not significantly alter body weight but led to dose-dependent increases in central adiposity, hepatic triglycerides, and markers of oxidative stress. Higher doses were also associated with impaired glycemic control, elevated liver enzyme levels, and increased free heme concentration in plasma, suggesting oxidative damage and hemolysis. Histological analysis revealed central vein congestion and hepatic structural alterations in exposed groups.

Conclusion

Sub-chronic inhalation of crude acetylene induced metabolic dysfunction characterized by impaired glucose regulation, hepatic steatosis, and oxidative stress, despite no changes in overall body weight. These findings highlight the potential health risks associated with acetylene exposure and underscore the need for regulatory measures to limit its use in fruit ripening.

Assessing the feasibility of the Virtual Reality Education and Acceptance Protocol among baseball and softball players

by Jarad A. Lewellen, Cami A. Barnes, Aidan Forget, Jeanette M. Garcia, D. Jake Follmer, Guy Hornsby, Hannah L. Silva-Breen, Peter R. Giacobbi Jr.

Research has supported the use of virtual reality (VR) in sport to train skills such as decision-making and anticipation, as well as aid in injury rehabilitation. Despite this, VR is not commonly used as a training tool in sport. Barriers to its adoption include a lack of understanding, low awareness, risk of cybersickness, and cost. As such, there is a critical need to address these barriers and promote acceptance of VR in sport. The purpose of this single-arm, non-randomized, mixed-methods feasibility trial was to examine the feasibility of the Virtual Reality Education and Acceptance Protocol (VREAP), which was designed by the study’s authors to address barriers to VR adoption. While the VREAP is intended to be used in multiple domains, we assessed its feasibility among baseball and softball players. Specifically, we assessed pre- and post-training attitudes toward VR using the Attitudes toward Virtual Reality Technology Scale (AVRTS), which uses the Technology Acceptance Model (TAM) as a guiding framework. Participants (n = 18) completed the VREAP, which includes stages of education, acclimation, and application. Exit interviews provided further insights into participant experiences. Results from quantitative and reflexive content analyses demonstrated feasibility of the VREAP based on recruitment and adherence, acceptability, demand, implementation, and practicality. Statistical analyses from the AVRTS revealed significant pre- to post-training increases in overall attitudes toward VR as well as increases in enjoyment, perceived usefulness, and ease of use. Minimal cybersickness was reported. Our findings demonstrate the feasibility of the VREAP among baseball and softball players and show promise for its future research and application.

The associations of premorbid social isolation and social support with self-rated health and heart failure outcomes in the atherosclerosis risk in communities (ARIC) Study

by Kennedy M. Peter-Marske, Annie Green Howard, Kelly R. Evenson, Sara Jones Berkeley, Joanna Maselko, Mario Sims, Stuart D. Russell, Anna Kucharska-Newton, Kevin J. Sullivan, Wayne D. Rosamond

We assessed whether social isolation (SI), social support (SS), and subtypes of SS were associated with self-rated health trajectories and clinical heart failure (HF) outcomes among participants with incident HF hospitalizations. We included 2967 Atherosclerosis Risk in Communities study participants with incident HF hospitalization after Visit 2 (1990–1992). SI, SS, and subtypes of SS were measured at Visit 2. We identified incident HF hospitalization as ICD-9 code 428 and physician adjudicated events; on average HF occurred 17 (SD 8) years after Visit 2. We assessed associations with trajectories of annually measured self-rated health in the 4 years prior to and after incident HF hospitalization (excellent/good self-rated health on a 0–100 scale), using linear mixed effects models. We calculated hazard ratios (HR) and 95% confidence intervals (CIs) for associations with time to first all-cause rehospitalization and all-cause mortality using Cox proportional hazard models. Low overall SS had a 5.8 point (95% CI 7.8, 3.8) lower self-rated health value over time than high SS; associations of subtypes of SS with this outcome were similar. Low belonging SS was associated with greater days to first rehospitalization (HR 0.85; 95% CI 0.79, 0.96) compared to the highest tertile; however, belonging SS was not associated with mortality (HR 1.05; 95% CI 0.95, 1.17). Being socially isolated/high risk for SI was associated with greater hazard of all-cause mortality among females (HR 1.57; 95% CI 1.20, 2.06) but not males (HR 0.95; 95% CI 0.75, 1.19), compared to low SI. SI and SS were not associated with number of hospitalizations in the first year or percent of first year spent at home.

Perceptions and attitudes of healthcare workers towards the use of digital facial recognition application in a health setting in Uganda: An exploratory pilot study

by Patrick Kaggwa, Juliet Nabbuye Sekandi, Mcdonald Kerone Adenike, Peter Nabende, Sarah Nabukeera, Kenneth Kidonge Katende, Esther Buregyeya, Nazarius Mbona Tumwesigye

Background

Unique patient identification is often challenging in healthcare systems, especially in low- and middle-income countries. Digital facial recognition is a promising alternative to traditional identification methods. This pilot study explores the perceptions and attitudes of healthcare workers towards using facial recognition technology in a healthcare setting in Uganda.

Methods

We conducted an explorative qualitative study using key informant interviews with healthcare workers in Kampala, Uganda, to assess perceptions and attitudes towards digital facial recognition. We interviewed a total of 10 healthcare workers, including five doctors and five nurses, aged 20–39 years, with at least one year of professional experience. A trained interviewer provided a brief overview and demonstration of the facial recognition application and then used an open-ended interview guide to elicit responses about perceptions and attitudes. The interviews were audio recorded and transcribed verbatim. Data obtained from Key Informant Interviews were manually analyzed using thematic content analysis.

Results

Overall, the healthcare workers perceived digital facial recognition as a more effective and acceptable way to identify patients who receive service at outpatient clinics. Four themes emerged, including: i) Challenges affecting current patient identification standards, ii) Healthcare workers’ views on facial recognition, iii) Perceived digital facial recognition implementation challenges, and iv) Solutions to challenges of digital facial recognition. The healthcare workers recommended ensuring the protection patients’ images privacy, providing adequate technological infrastructure in clinics, and securing stable internet access for the successful implementation of digital facial recognition.

Conclusion

Our exploratory study indicates that overall, healthcare workers have a positive perception of the digital facial recognition application. However, it is crucial to acknowledge and address concerns regarding confidentiality and privacy to pave the way for the future implementation of the system.

Evaluation of the Integration of Genetics and Genomics Into Nursing Practice

ABSTRACT

Purpose

Assess US registered nurse genomic competency.

Design

Administered the Genetics and Genomics Nursing Practice Survey (GGNPS).

Methods

GGNPS assesses genomic knowledge, skills, attitudes, confidence, and utilization in nursing practice. Distributed by the American Nurses Association via email and online to US registered nurses. Results are analyzed using descriptive statistics and compared to 2010 data.

Results

1065 registered nurses responded. Most (41%) were Master's prepared, actively seeing patients (51%) and 66% considered it very important to learn more about genomics. Most (55%) reported their genomic knowledge was poor yet 51% reported a patient initiated a genetic discussion with them in the past 3 months. 66% completed all knowledge score items with a median score of 9/12, no change from 2010. Only 26% had heard of the Essential Competencies. Most reported no genomic curricular content (64%); had not attended a genomic course since licensure (64%); intended to learn more about genomics (70%); and would attend a course on their own time (79%).

Conclusions

Nurses felt genomics was important but have capacity deficits. Despite genomic discoveries and evidence-based practice guidelines that impact healthcare quality and safety, 20 years after the Genomic Competencies were established (2005) nursing genomic practice capacity remains low.

Clinical Relevance

Genomics is critical to the safe, quality nursing practice regardless of the level of academic training, clinical role, or specialty.

Stay or go? Exploring physician turnover in European Hospitals–Evidence from the METEOR survey

by Laura Maniscalco, Marco Enea, Peter de Winter, Neeltje de Vries, Anke Boone, Olivia Lavreysen, Kamil Baranski, Walter Mazzucco, Adriano Filadelfio Cracò, Malgorzata Kowalska, Szymon Szemik, Lode Godderis, Domenica Matranga

According to the World Health Organization (WHO), in 2022 there was a shortfall of approximately 1.2 million doctors, impacting healthcare system and patient care. Understanding turnover intentions is crucial for managing the healthcare workforce and ensuring continuous, and high-quality patient care. This study investigates the prevalence of physicians planning to leave their hospital or the profession, and risk factors such as job demand, resources, satisfaction, and burnout across four European countries. A cross-sectional multicenter study was conducted in eight hospitals across Belgium, the Netherlands, Poland and Italy, including both academic and non-academic institutions. Data from Poland were excluded due to a low response rate, to preserve respondent anonymity. Multivariable logistic regression analyses were performed, adjusted for country, demographics, and work context, using significant variables from the univariable analysis. The overall intention to leave the hospital was 16.5%, with the highest rates in Belgium (19.6%) and Italy (19%), and the lowest in the Netherlands (9.8%). The intention to leave the profession was 9.1%, with the highest rate in the Netherlands (16.1%), followed by Belgium (6.3%) and Italy (5.7%). Physicians at higher risk of leaving the hospital were younger (adjOR = 0.90, 95%CI = 0.86–0.93), lacked colleague support (adjOR = 3.18, 95%CI = 1.06–9.36), and were dissatisfied with job prospects (adjOR = 2.38, 95%CI = 1.02–5.54) and overall work (adjOR = 2.71, 95%CI = 1.09–6.69). Those more likely to leave the profession were from the Netherlands (adjOR = 4.14, 95%CI = 1.62–11.4), surgeons (adjOR = 2.90, 95%CI = 1.22–6.78), working in non-academic hospitals (adjOR = 2.43, 95%CI = 1.01–5.97), lacked development opportunities (adjOR = 5.97, 95%CI = 1.01–36.2), or were dissatisfied with career prospects (adjOR = 2.77, 95%CI = 1.04–7.27). Health system managers and relevant stakeholders involved in the planning, implementation, or evaluation of health policies and reforms aimed at improving healthcare job retention should take into account the key determinants of the intention to leave identified in this study.

Frequencies and predictors of missing values as an indicator of data quality in a large population-based sample: an analysis of baseline data from the Hamburg City Health Study

Por: Wiessner · C. · Freitag · J. · Becher · H. · Härter · M. · von dem Knesebeck · O. · Petersen · E. L. · Stahlmann · K. · Briken · P. · Schulz · H. · Bleich · C.
Objective

Data quality in epidemiological studies is a basic requirement for good scientific research. The aim of this study was to examine an important indicator of data quality, data completeness, by investigating predictors of missing data.

Methods

Baseline data of a cohort study, the population-based Hamburg City Health Study, were used. Missingness was investigated at the levels of a whole research unit, on the two segments of health service utilisation and psychosocial variables, and two sensitive items (income and number of sexual partners). Predictors for missingness were sociodemographic variables, cognitive abilities and the mode of data collection. Associations were estimated using binary and multinomial logistic regression models.

Results

Of 10 000 participants (mean age=62.4 years; 51.1% women), 32.9% had complete data at the unit level, 66.8% had partially missing data and 0.3% missed all items. The highest proportions of missing values were found for income (27.8%) and the number of sexual partners (36.7%). At both the unit, segment and item level, older age, female sex, low education, a foreign mother language and cognitive impairment were significant predictors for missingness.

Conclusion

For analysing population-based data, dealing with missingness is equally important at all levels of analysis. During the design and conduct of the study, the identified groups may be targeted to reach higher levels of data completeness.

Peer‐Mentor Support for Older, Vulnerable Patients With Ischemic Heart Disease: A Mixed Methods Process‐Outcome Evaluation

ABSTRACT

Aim

To achieve a deeper understanding of the results of a primary randomised controlled trial to clarify the potential effective mechanisms and barriers of a peer-mentor intervention.

Design

Mixed methods process-outcome evaluation of the intervention.

Method

Qualitative and quantitative data were collected during the intervention in a during-trial set-up, that is, a convergent design.

Results

The qualitative and quantitative findings mostly confirmed and expanded each other, identifying several mechanisms that facilitate the effectiveness of peer-mentor support during cardiac rehabilitation, such as mentors' experience-based knowledge and motivation. However, barriers related to lifestyle changes among older, vulnerable patients (e.g., mentee concerns about heart-healthy diets) and psychological outcomes (e.g., mentees' resilience) may minimise the effectiveness.

Conclusion

Peer-mentoring holds potential for supporting older, vulnerable patients during cardiac rehabilitation. However, ensuring that peer-mentors are well-suited for their role and capable of providing motivational, experience-based support is crucial, as is the need for tailored mentorship and consideration of specific patient populations needing mentor-supported cardiac rehabilitation.

Implications and Impact

Cardiac rehabilitation faces challenges due to high drop-out rates, particularly among older individuals, females, and vulnerable patients. Peer mentoring, a low-cost intervention, holds promise for supporting these groups in cardiac rehabilitation programmes.

Reporting Method

The study adheres to the ‘Systematic Development of Standards for Mixed Methods Reporting in Rehabilitation Health Sciences Research’, ‘Good Reporting of A Mixed Methods Study’ and ‘Template for Intervention Description and Replication’.

Patient and Public Contribution

A group of patients with cardiovascular disease actively contributed to developing and implementing the intervention.

Trial and Protocol Registration

ClinicalTrials.gov Identifier: NCT04945486—prospectively registered before the first participant was recruited

The Impact of a Planned Change to Nurse Staffing Levels in Emergency Departments: A Pre‐Test, Post‐Test Design

ABSTRACT

Aim

To examine burnout levels, nurse perceptions of the work environment, job satisfaction, intention to stay and quality of care for nurses working in emergency departments before and following a planned change to nurse staffing levels.

Design

A pre-post observational design.

Methods

A systematic approach (Nursing Hours per Patient Presentation) was introduced to determine nurse staffing levels based on patient presentations resulting in adjustments to nurse staffing. Data on burnout, the work environment, intention to stay, job satisfaction and quality of care were collected from three emergency departments prior to and following the adjustments to nurse staffing.

Results

An adjustment to nurse staffing levels was made to all three emergency departments. Mean emotional exhaustion scores were significantly lower, and quality of work environment scores and levels of job satisfaction were significantly higher for nurses following staffing adjustments. There was an increase to the proportion of nurses who perceived an improvement in quality of care delivered. In general, the results indicated improvements in outcomes following adjustments to nurse staffing levels.

Conclusion

A more holistic organisational approach is required to address staffing in emergency departments. Initiatives that involve frontline nurses in resource planning facilitating a bottom-up approach to allow for improved work environments would be beneficial.

Impact

This study addressed a planned change to nurse staffing levels in emergency departments and staff outcomes pre and post changes to staffing levels.

This study highlighted that staffing an emergency department, based on nursing hours per patient presentation, was associated with improvements in staff outcomes.

The research will impact on nurses working in emergency departments as outcomes from this research were used to develop a Framework for Safe Nurse Staffing and Skill Mix in Emergency Care Settings.

Reporting Method

STROBE and SQUIRE checklist.

Patient or Public Contribution

No Patient or Public Contribution.

Understanding Self‐Care Patterns in Adults With Type 1 Diabetes: Insights From a Mixed Methods Study

ABSTRACT

Aim

The aim of this study was to explore self-care among adults with type 1 diabetes (T1D) to (1) characterise possible self-care profiles in adults with T1D; (2) explain self-care maintenance, monitoring and management within the self-care profiles; and (3) develop a typology of self-care in adults with T1D.

Design

Mixed-methods study with explanatory sequential design.

Methods

Participants (n = 200) completed a validated self-care survey. Cluster analysis of survey data was performed to identify self-care profiles. Then, semi-structured individual interviews were performed with a nested sample (n = 20) stratified by these profiles. Directed content analysis was applied to transcript data to describe self-care within profiles. Findings were integrated via joint display to develop a typology of self-care in adults with T1D.

Data Sources

A total of 200 adults with T1D were recruited from a diabetes centre in a large, urban US city from 6/2022 to 11/2022 (quantitative phase) and a nested sample (n = 20) from 12/2022 to 4/2023 (qualitative phase).

Results

We identified three self-care profiles: Expert, Inconsistent and Novice. Expert self-care was characterised by a steadfast and holistic approach to maintaining health, the use of internal and external cues to monitor for health changes and informed management decision-making when health changes were detected. Inconsistent self-care was characterised by the capability to maintain health, often limited by low health prioritisation, a lack of perceived need for greater effort and compulsive management decision-making. Novice self-care was characterised by difficulty maintaining health and limited skill development in more advanced self-care processes, including monitoring for and managing health changes.

Conclusions

This study identified an Expert–Inconsistent–Novice typology of self-care in adults with T1D, aligning with previous research and suggesting a stable typology across conditions.

Implications for the Profession and/or Patient Care

Characterising self-care among adults with T1D may facilitate aligning support with individual needs.

Impact

Progression towards Expert self-care may offer clinically meaningful improvements in glycaemic control and reduced risk for diabetes complications.

Reporting Method

Good Reporting of A Mixed Methods Study (GRAMMS) Checklist.

Patient or Public Contribution

No patient or public contribution.

Pursuing Reduction in Fatigue After COVID-19 via Exercise and Rehabilitation (PREFACER): a protocol for a randomised feasibility trial

Por: Billias · N. · Pouliopoulou · D. V. · Lawson · A. · DAlessandro · V. · Bryant · D. M. · Peters · S. · Rushton · A. B. · Miller · E. · Brunton · L. · McGuire · S. · Nicholson · M. · Birmingham · T. B. · MacDermid · J. C. · Quinn · K. L. · Razak · F. · Goulding · S. · Galiatsatos · P. · Sa
Introduction

Over 777 million COVID-19 infections have occurred globally, with data suggesting that 10%–20% of those infected develop Long COVID. Fatigue is one of the most common and disabling symptoms of Long COVID. We aim to assess the feasibility and safety of a new, remotely delivered, multimodal rehabilitation intervention, paced to prevent post-exertional malaise (PEM), to support the conduct of a future, definitive randomised trial.

Methods and analysis

We will conduct a randomised, two-arm feasibility trial (COVIDEx intervention vs usual care). Sixty participants with Long COVID will be recruited and randomised prior to giving informed consent under a modified Zelen design using 1:1 allocation with random permuted blocks via central randomisation to receive either the COVIDEx intervention or usual care. The 50-minute, remotely delivered, COVIDEx intervention will occur twice weekly for 8 weeks. All participants will wear a non-invasive device throughout their entire study participation, to track heart rate, blood oxygen saturation, steps, sleep and monitor PEM. The primary feasibility objectives will be recruitment rates, intervention fidelity, adherence, acceptability (intervention and design), retention, blinding success and outcome completeness. Secondary objectives will include refined estimates for the standard deviation and correlation between baseline and follow-up measurements of fatigue. Feasibility and clinical outcomes will be collected at baseline, 4, 8, 12 and 24 weeks. Qualitative interviews with participants and physiotherapists will explore intervention acceptability and barriers/facilitators.

Ethics and dissemination

Ethical approval for this study was obtained by the Western University Health Sciences Research Ethics Board (REB# 123902). Dissemination plans include sharing of trial findings at conferences and through open access publications and patient/community channels.

Trial registration number

NCT06156176

Study protocol for developing the evaluation instrument of guideline adherence to GRADE approach (GRADE-Check)

Por: Jin · Y. · Yan · S. · Yao · X. · Dahm · P. · Alonso-Coello · P. · Brignardello-Petersen · R. · Keitz · S. · Rylance · J. · Cheung · M. · Agoritsas · T. · Kunkle · R. · Murad · M. H. · Guyatt · G.
Introduction

Many clinical practice guidelines (CPGs) claim to use Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, but its implementation varies. This suggests that CPG developers, methodologists and users would benefit from an instrument to evaluate the extent to which CPGs adhere to GRADE approach. Such a structured instrument is currently unavailable. Accordingly, this study will develop an evaluation instrument for assessing guideline adherence to the GRADE approach, which we have named ‘GRADE-Check’. The goal is to target items to which CPGs fail to adhere and that potentially have serious consequences resulting in inaccuracies in certainty of evidence and inappropriate direction or strength of recommendations, thereby discriminating across CPGs in issues of importance.

Methods and analysis

The panel will include up to 25 individuals with specific knowledge and expertise, including experienced authors, educators and methodologists on CPGs methodology and GRADE approach from relevant organisations. The instrument will focus on the key elements of GRADE, aiming for clarity for GRADE experts and non-GRADE experts to apply. The development process for GRADE-Check will consist of the following five phases: (1) recruitment of a panel of GRADE experts; (2) development of objectives and scope for the development of GRADE-Check and criteria for item selection; (3) generation of candidate items through a literature review and panel consultation; (4) panellist discussion to construct the initial draft and extended explanation manual and (5) user testing.

Ethics and dissemination

This study has been approved by the Medical Ethics Committee of Zhongnan Hospital of Wuhan University (no. (2025047K)). Our research findings will be published in peer-reviewed journal articles and presented at academic conferences. Additionally, the dissemination plan will include considerations for the development of implementation manuals, a dedicated project website and training tools.

Procedural and Therapy Peripheral Intravenous Catheters: A Framework for Safety, Quality and Patient‐Centred Care

ABSTRACT

Aim

To introduce a novel conceptual framework that differentiates peripheral intravenous catheters according to their dwell time and therapeutic purpose, in order to improve the suitability of material choice, safety and cost-effectiveness.

Design

Concept based on clinical guidelines, expert consensus and recent peer-reviewed evidence.

Data Sources

A literature search was conducted in PubMed on November 25, 2024, using defined keywords related to peripheral intravenous catheters, device complications and duration of use. This search was supplemented by manual screening of references from relevant articles.

Methods

The analysis followed the SANRA quality criteria for narrative reviews. Evidence and recommendations from clinical guidelines, randomised trials and qualitative studies were synthesised using the Australian Clinical Care Standards to structure the proposed classification into ‘procedural’ and ‘therapy’ catheters.

Results

Procedural catheters are used for less than 24 h, typically during procedures or short treatments, and are mainly linked to immediate risks like insertion failure and local trauma. Therapy catheters, defined as devices used beyond 24 h or expected to remain while the patient sleeps, carry cumulative risks, including delayed complications such as phlebitis, occlusion and infection. The framework supports more nuanced decisions on device choice, insertion site and maintenance.

Conclusion

This framework introduces a practical differentiation between short- and longer-term peripheral venous catheters, addressing a major oversight in existing guidelines and supporting context-sensitive vascular access decisions.

Implications for the Profession and/or Patient Care

Tailoring catheter management to expected dwell time may reduce complications and costs, enhance workflow, and improve patient comfort.

Impact

By addressing the lack of temporal distinction in current practice, this framework offers a simple yet transformative tool applicable across care settings, with the potential to improve patient outcomes, resource utilisation and costs.

Patient or Public Contribution

This project is a concept analyses; no patient or public contribution was necessary.

‘Just Put Up With It’: Women's Experiences of Perimenopause and Menopause

ABSTRACT

Aim

To report on women's experiences of perimenopause and menopause.

Design

A mixed-methods design using an online survey and interviews.

Methods

Data were collected simultaneously between April and July 2022. Women over the age of 18 who self-identified as being in perimenopause or menopause were invited to complete an online survey. Women who completed the survey were also invited to participate in an interview to discuss their experiences in more detail. Quantitative data were analysed using descriptive statistics. Qualitative data were transcribed verbatim and thematically analysed.

Results

Four hundred and eleven women completed the survey in its entirety. Twenty-five women who self-identified as being in perimenopause and menopause participated in one-on-one interviews. Both quantitative and qualitative data are presented under three themes: (1) The unexpected sequelae on daily life; (2) Experiencing stigma and shame; and (3) Feeling dismissed and devalued.

Conclusion

Gender inequality, silence and stigma negatively impact the health and well-being of women experiencing perimenopause and menopause. Encouraging conversations and challenging existing negative attitudes to perimenopause and menopause can reduce stigma, improve health literacy and enhance women's experiences of this life transition.

Implications for the Profession and or Patient Care

Further education for nurses and other health care professionals about perimenopause and menopause is required to better diagnose, treat and support women. Nurse-led models of care could provide timely access to menopause care. Workplaces could enhance the productivity and work satisfaction of women experiencing perimenopause and menopause by changing policy to ensure flexibility in the workplace and implementing measures to ensure their comfort.

Summary Statement

Women are largely unprepared for the impact perimenopause/menopause has on their everyday lives. The stigma and shame associated with perimenopause and menopause limits women's access to support and contributes to negative outcomes for their health and well-being. Health professionals often have inadequate knowledge about perimenopause and menopause and can be dismissive of women experiencing this transition.

Reporting Method

Reporting of the study was guided by The Good Reporting of a Mixed Methods Study (GRAMMS) checklist.

No Patient or Public Contribution

This study did not include patient or public involvement in its design, conduct or reporting.

Mechanisms of change in naturalistic mental health care settings: study protocol for a longitudinal multimethod study

Por: Heim · P. · Brose · A. · Böttche · M. · Peters · E. M. J. · Ehrenthal · J. C. · Knaevelsrud · C. · Kerber · A.
Introduction

Mental disorders are among the leading causes of the global burden of disease and are often associated with severe functional impairment and high societal costs. Psychotherapeutic, psychopharmacological and internet-based mental health interventions have proven to be helpful, but challenges remain, including only moderate response rates, high relapse rates and barriers to accessing mental healthcare. Much of the existing evidence stems from studies conducted in controlled, often standardised settings that only partially reflect real-world conditions, contributing to a ‘scientist-practitioner gap’. Moreover, the mechanisms of change, such as the interaction between treatment intensity, common factors (eg, the therapeutic relationship) and specific intervention techniques, have not been sufficiently investigated. In particular, the relationship of changes in personality functioning (PF) with mental and physical health has not yet been extensively researched.

Methods and analysis

The PSYMPACT (Psychological Impact Factors of Mental Health Treatments) study will use a longitudinal study design with a naturalistic sample (N 3000) to examine changes in psychopathology, PF and allostatic load in psychotherapeutic, psychopharmacological and internet-based treatments. The aim is to identify factors contributing to improvements and deteriorations in mental and physical health across different settings, including common and specific factors. Additionally, to provide patient perspectives, qualitative interviews will be conducted with individuals with varying levels of severity of mental health problems. Allostatic load will be assessed using repeated hair cortisol measurements. Furthermore, ecological momentary assessment will be used to examine the diurnal variability of PF as well as its more momentary correlates and longer-term outcomes. The central research questions and aims include (1) the assessment of common factors across different treatment settings, (2) associations of specific and common factors with improvements in mental health, including PF, (3 and 4) the importance of treatment intensity and interaction effects with common and specific factors, (5) the association of changes in psychopathology with changes in allostatic load, (6) the trait and state variability of PF, (7) the identification of patients who deteriorate under specific treatments and (8) patients’ perspectives on the effectiveness of different treatment modalities.

Ethics and dissemination

Approval was obtained from the Ethics Committee of the Department of Education and Psychology at the Freie Universität Berlin, Germany. Results will be submitted to peer-reviewed specialised journals and presented at national and international conferences.

Registration details

Before data collection started in November 2024, the study was registered in the German Clinical Trials Register (https://www.drks.de/search/de/trial/DRKS00035560).

The Aggression and Violence Evaluation of Risk Tool: A Context‐Specific Instrument to Assess Risk of Violence in the Emergency Department

ABSTRACT

Aim

To evaluate the relationship between the Bröset Violence Checklist and additional risk factors identified in prior research by our team to determine which combination best predicted an emergency response to a violent incident in an emergency department.

Design

A prospective observational study was used to collect data about a single cohort of adult patients admitted in August 2024.

Method

Nurses who use the Bröset Violence Checklist as part of routine observations scored eight additional violence indicators and recorded security incidents.

Results

Data from 5634 observations, 1762 patients, and 68 emergency incidents was analysed using a combination of descriptive and inferential statistics to evaluate the relationship between factors and incidents. Seven factors correlated significantly with violence (p < 0.05). Three factors (verbal threats, physical threats, and attacking objects) were excluded as they represent manifestations of violence rather than predictive indicators. Receiver Operating Characteristics analysis of the combination of the remaining four factors (history of violence, drug and/or alcohol influence, agitation/restlessness, and imposed restrictions) revealed an Area Under the Curve of 0.98.

Conclusion

The findings were integrated to develop a revised instrument—the Aggression and Violence Evaluation of Risk Tool. This new tool demonstrates equivalent predictive capability to the Bröset Violence Checklist, yet it is simpler and easier to use.

Impact

Context-specific violence assessment schemes are needed to strengthen risk mitigation strategies. The Aggression and Violence Evaluation of Risk Tool incorporates unique situational risks developed specifically for emergency departments. It has the potential to effectively ameliorate violence risk and enhance worker and patient safety.

Reporting Method

STROBE has been followed.

Implications

The findings produced an instrument that can be translated to emergency departments to reduce the prevalence of violence.

Patient or Public Contribution

Limited patient and public involvement comprising observations of adult patients in an emergency department in Melbourne, Australia.

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