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Interventions targeting internalised racism: a scoping review protocol

Por: Sissoko · G. D. · McKenley · C. · Funaro · M. C. · Haeny · A. M.
Introduction

Internalised racism (IR) is broadly defined as the acceptance of negative racial stereotypes, beliefs and attitudes about one’s own racial or ethnic group. IR is increasingly recognised as a critical component and consequence of racial stress and trauma. Although IR has been linked to a variety of adverse mental and physical health outcomes, the phenomenon remains under-represented in intervention research. This scoping review addresses this gap by systematically mapping the range of interventions and intervention components that explicitly target IR among racially or ethnically minoritised communities and their health-related outcomes. This protocol paper will describe the process of the scoping review.

Methods and analysis

This review will follow methodology from the Joanna Briggs Institute and report using the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist. Using identified controlled vocabulary and keywords, searches will be undertaken using the following databases: MEDLINE, PsycInfo, Embase and Web of Science. This review will include studies describing any intervention or intervention component designed to reduce IR that is conducted with racially or ethnically minoritised populations in any context or setting. No date limit will be applied, and the study must be available in English. Conceptual or opinion pieces without a clear intervention framework will be excluded. Two reviewers will independently screen and select sources and extract data on intervention characteristics, theoretical underpinnings, outcomes and implementation details. Descriptive statistics will summarise study characteristics and outcomes, while a narrative synthesis will explore how interventions conceptualise and address IR. The findings will map existing approaches, highlight research gaps and inform future clinical practice and intervention development.

Ethics and dissemination

As this review uses published and publicly available data, no ethical approval is required. The findings will be disseminated through a peer-reviewed publication, conference presentations and briefs to stakeholder networks.

Registration

This protocol is registered on the Open Science Framework (https://doi.org/10.17605/OSF.IO/4VDBX).

Effect of music therapy on vital signs and heart rate variability of paediatric patients during the extubation process in the paediatric intensive care unit: a multicentre randomised clinical trial protocol

Por: Beltran · Y. M. · Charum · D. P. · Zuluaga · C. A. · Vega · M. A. · Benavides-Cruz · J. · Amarillo · M. · Canon · E. · Alvarez · I. · Ramirez-Moreno · J. · Paez · L. · Garzon · M. C. · Calderon · P. D. · Quintero · T. C. · Moreno · J. · Ettenberger · M.
Introduction

A successful extubation process is critical for the future health outcomes of paediatric patients, as it tests the functioning of the respiratory system without the support of mechanical ventilation. However, extubation can cause stress, pain, anxiety or discomfort in patients, which may sometimes lead to an increased likelihood of reintubation. Music-based interventions and therapies have been shown to be effective in reducing anxiety and stress levels in ventilated patients in the paediatric intensive care unit (PICU), but studies evaluating the effect of music therapy during the extubation process in the PICU are scarce.

Methods and analysis

This is a pragmatic multicentre randomised clinical trial with two parallel arms. The intervention group will receive standard care + music therapy during the extubation process, and the control group will receive standard care alone. The main outcome measure is heart rate, which will be measured every minute for 5 min pre-extubation, during the extubation process and up to 10 min postextubation. Secondary outcome measures are: oxygen saturation, respiratory rate, blood pressure and heart rate variability. A total of 82 patients will be randomised.

Ethics and dissemination

This study was approved by the Research Ethics Committee of the Fundación Universitaria Sanitas (CEIFUS 1356-24, date of approval: 3 May 2024). All parents or legal guardians of patients will sign a written informed consent, and if applicable, assent from participants will be sought. The results will be disseminated through publications in peer-reviewed journals, conferences and presentations at the hospitals’ clinical committees.

Protocol version

Version 1.0, 18 December 2024.

Trial registration number

NCT06591533, trial registration date: 10 September 2024.

Perception of primary-secondary care collaboration among general practitioners and specialists and the perceived potential for innovation: an exploratory qualitative study

Objectives

Our objective was to examine the barriers and facilitators encountered by primary and secondary healthcare professionals when collaborating at the care continuum between primary and secondary care. We aimed to identify specific challenges, observed benefits and proposed changes. By analysing these experiences and identifying opportunities for redesign, we aimed to define specific domains that could improve collaboration, thereby supporting sustainable access to and quality of care in the face of rising demand and constrained resources.

Design

A qualitative exploratory study using semi-structured interview data guided by two domains of the Consolidated Framework for Implementation Research (CFIR), including Inner Setting—Tension for Change and Individual Characteristics, as well as selected implementation outcomes defined by Proctor et al, all viewed through a service (re)design lens.

Setting

Consultation and communication between primary and secondary healthcare professionals in a Dutch urbanised area.

Participants

37 users of collaboration services (eg, telephone, correspondence) were interviewed between August 2021 and October 2022, including 14 general practitioners (GPs) (10 females, 4 males) and 23 specialists (10 females, 13 males).

Results

Four key domains with subthemes, subdivided per operation and CFIR domain, were identified as central to optimising the collaboration of professionals within the primary-secondary care continuum: (1) software and record integration; (2) seamless personal interaction; (3) eliminating a sense of ‘us vs them’ and (4) gaps in continuity of care.

Conclusions

This study reveals that healthcare professionals in both primary and secondary care face similar collaboration challenges due to system-level issues and inadequate collaboration tools, leading to increased workload, miscommunication and reduced quality of care. Improving collaboration between GPs and specialists requires not only adjustments to individual services, but a comprehensive overhaul of the referral and back-referral process. A more integrated approach, addressing key domains, is crucial for enhancing care quality, streamlining workflows and improving health outcomes.

Testing psychosocial work adversities as a necessary condition for work-related emotional exhaustion in young workers: a cross-sectional necessary condition analysis on a national general working population-based survey

Por: Schelvis · R. M. C. · van Veen · M. · Tamminga · S. J. · Oude Hengel · K. M. · Nieuwenhuijsen · K. · Boot · C. R. L. · Dul · J.
Objectives

Being exposed to adverse psychosocial working conditions contributes to poor mental health in young workers. This study explores whether psychosocial work adversities are a necessary condition for work-related emotional exhaustion in young workers.

Design

Data from the ‘Netherlands Working Condition Survey 2021’ was used. By applying a novel method called Necessary Condition Analysis, we tested two psychosocial work adversities as necessary conditions for high work-related emotional exhaustion in young workers: (1) a composite score of high job demands and low job resources and (2) a composite score of high job demands. Additionally, we tested whether the threshold for job demands as a necessary condition for high work-related emotional exhaustion differed for young workers with low versus high resources.

Setting

Secondary data analysis on a national working population-based survey.

Participants

The sample included 5791 young workers in the Netherlands (aged

Primary outcome measure

Work-related emotional exhaustion.

Results

A high level of the composite on job demands and job resources is necessary for a high level of work-related emotional exhaustion in young workers (effect size=0.11, p

Conclusions

Both psychosocial work adversities were necessary conditions for high work-related emotional exhaustion in young workers. The necessity threshold for job demands was higher for young workers with high job resources, compared with the group with low resources. This indicates that removing psychosocial work adversities and ensuring the presence of job resources might contribute to the prevention of high work-related emotional exhaustion in young workers.

Implementation strategy for an antibiotic stewardship bundle to promote optimal treatment choices in neonates with suspected early-onset sepsis (Protect-Neo): a study protocol for a multicentre, prospective interrupted time series and before-after study

Por: van Veen · L. E. J. · Tramper-Stranders · G. A. · Achten · N. B. · Plötz · F. B. · van Rossum · A. M. C. · Ista · E.
Background

Several antibiotic stewardship interventions have been proven effective and safe for reducing the high number of antibiotic prescriptions in late preterm and term neonates at risk of early-onset sepsis (EOS). For successful translation of EOS interventions to clinical practice, implementation strategies should be employed targeting stakeholders. The primary aim of this study is to assess the impact of implementing an antibiotic stewardship bundle, including the EOS calculator, procalcitonin-guided therapy and intravenous-to-oral switch therapy on antibiotic exposure for EOS in Dutch secondary hospitals. Secondary aims are to examine additional clinical outcomes and implementation outcomes.

Methods and analysis

We will conduct a multicentre, prospective implementation study with interrupted time series and before-after analyses at the paediatric or specialised neonatal departments of 11 Dutch secondary hospitals and their surrounding neonatal care networks. A multimodal implementation strategy, designed using Implementation Mapping, is employed to facilitate implementation. The study population is twofold: (1) neonates born at 34 weeks of gestation or later with suspected EOS that will receive intervention-related care and (2) paediatricians, paediatric residents, neonatal nurses, maternity nurses and parents who are the focus of the implementation strategies. The primary outcome is days of antibiotic therapy per 1000 live-born neonates, which will be evaluated using interrupted time series analysis as well as before-after comparison. Secondary clinical outcomes will be assessed by comparing clinical data from the 12 months pre-implementation and post implementation. Implementation outcomes are adoption, fidelity, feasibility and acceptability of the interventions and fidelity and appropriateness of the implementation strategies. Implementation outcomes will be assessed using both qualitative and quantitative methods, including surveys, individual interviews and focus group interviews. A mixed-methods approach will be used to integrate clinical and implementation outcomes.

Ethics and dissemination

The Medical Ethics Committee United (MEC-U) declared (reference: W24.132) that this study does not fall under the Dutch Medical Research Involving Human Subjects Act (WMO). Subsequently, ethical approval was granted by the Scientific Committee of the Franciscus Hospital (T110). The scientific committees of all participating sites adopted this decision and granted permission for local conduct of the study. As electronic health record data are sampled retrospectively and anonymously, a waiver of consent was given to collect these data. Informed consent will be obtained from participants completing surveys or taking part in interviews and focus group discussions. The findings will be disseminated through journal publications and conference presentations. Furthermore, practice and policy recommendations will be collaboratively developed with partner organisations.

Trial registration number

NCT06845332.

Cohort profile: a prenatal birth cohort study of intergenerational risk and resilience after conflict and forced displacement

Por: Wuermli · A. · Hiott · M. C. · Ugarte · E. · Rahman · M. S. · Elahi · M. · Rahim · A. · Dutta · G. K. · Ahamed · M. S. · Roy · B. R. · Akhter · R. M. · Hossain · E. · Michael · D. · Ayrin · T. K. · Haseen · S. H. · Alam · R. B. · Ratul · T. I. · Horaira · M. A. · Gladstone · M. · Sanin · K.
Purpose

As of 2024, 123.2 million people had been forcibly displaced as a result of persecution, armed conflict or climate-related catastrophes, and these numbers are predicted to rise. There is a growing awareness of possible intergenerational effects of trauma on life-course health and well-being, however few studies have followed individuals longitudinally starting prenatally. This paper describes the first large prenatal birth cohort study in a refugee context in a lower middle-income country. This study aims to investigate the potential lifespan health and developmental implications of being born into a protracted humanitarian context, and what factors can buffer from the adversity posed by conflict and displacement.

Participants

We outline our approach of recruiting, consenting and gathering data from pregnant Rohingya refugee and host community women (N=2888; 80% Rohingya) over the course of 12 months in Cox’s Bazar, Bangladesh.

Findings to date

A fifth wave of data collection, when children were 6 months old, was completed in April 2025. Rohingya women were substantially less literate; were marrying and having children at slightly younger ages, were more likely to live in crowded, resource-limited households and exhibited higher rates of clinically significant post-traumatic stress disorder and anxiety than host community women.

Future plans

There is a critical need for research in displaced populations in order to elucidate potentially lasting transgenerational impacts of experiencing conflict and displacement trauma, and the prenatal and postnatal factors that support health and development across the life span. The next follow-up is planned when the children turn 36 months of age (starting March 2026).

Patient-related and organisational characteristics associated with late cancellations and non-attendance in diabetes outpatient care: a cross-sectional study

Por: Singstad · T. · Holmen · H. · Smastuen · M. C. · Nermoen · I. · Ribu · L. · Torbjornsen · A.
Objective

We aimed to explore the patient-related and organisational characteristics associated with late cancellations and non-attendance in diabetes outpatient care and present our findings organised as a risk matrix based on these characteristics.

Design

A cross-sectional study.

Setting

Our study was conducted at an endocrinology outpatient clinic based on data extracted between January and December 2019 from electronic medical records.

Participants

Adult patients with type 1 diabetes with late cancellations or non-attendance. We compared our sample with national data for comparison and to assess representativeness.

Primary and secondary outcome measures

Main outcome was late cancellations or non-attendance, while secondary outcomes included type of cancellations and reason for cancellation.

Results

In total, 541 patients had late cancellations or non-attendance across 5040 diabetes consultations. These patients had a mean age of 43 years, 57.9% were men and half (n=301, 55%) were employed. The mean diabetes duration was 18 years, and the mean HbA1c level was elevated at 72 mmol/L. The outpatient clinic had a higher number of consultations, but the patient characteristics were comparable to the national average. Half of the patients (n=258, 52.3%) had late cancellations ahead of their consultations. Most cancellations occurred during the winter, mainly due to illness being the most frequent reason. Unemployed men with poorly regulated diabetes were more likely not to attend compared with employed females.

Conclusions

Characteristics such as being male, unemployed and having elevated HbA1c levels were significantly associated with non-attendance. Our findings contribute to understanding the reasons for at-risk patients missing consultations.

Impact of mental health status and clinical factors on health-related quality of life in patients undergoing haemodialysis: a multicentre cross-sectional study

Objectives

This study aimed to investigate the factors influencing health-related quality of life (HRQoL) in patients undergoing haemodialysis, focusing on the association between HRQoL dimensions and sociodemographic variables, clinical parameters, mental health status and biochemical indicators.

Design

A multicentre cross-sectional study conducted over 30 months.

Setting

The study was carried out in secondary care centres across multiple locations in the Community of Extremadura, Spain.

Participants

A total of 150 patients undergoing haemodialysis were recruited between March 2022 and September 2023. Inclusion criteria required patients to be diagnosed with chronic kidney disease (CKD) and undergoing haemodialysis. Patients unable to provide informed consent or with severe cognitive impairment were excluded.

Primary and secondary outcome measures

HRQoL was assessed using the Kidney Disease Quality of Life 36-item Short Form scale. Mental health parameters, specifically anxiety and depression, were evaluated using the Hospital Anxiety and Depression Scale. Biochemical markers such as haemoglobin and haematocrit levels, as well as sociodemographic and clinical data, were analysed for their influence on HRQoL.

Results

Symptoms of anxiety and depression were prevalent among patients undergoing haemodialysis. Anxiety had the greatest negative effect on HRQoL, being significantly associated with lower scores in the mental component summary (MCS) (β = –2.06; 95% CI –2.78 to –1.33; R² = 0.106; p

Conclusions

Depression and anxiety, along with older age, were identified as key factors negatively affecting HRQoL of patients undergoing haemodialysis. Management of mental health, alongside optimisation of clinical care to minimise complications, could enhance the HRQoL in this patient population. Further research is recommended to develop targeted interventions addressing anxiety and other modifiable factors influencing HRQoL in haemodialysis patients.

Sex differences in acute myocardial infarction: protocol for an umbrella review

Por: Torris · C. · Bjornnes · A. K. · Hagen · M. C. · Halvorsen · S. · Jernberg · T. · Lie · I.
Introduction

In recent decades, differences in the risk factors, presentations, management strategies and outcomes of acute myocardial infarction (AMI) between the sexes have emerged. Several systematic reviews and meta-analyses (SMRAs) on this specific topic have been conducted, and an overall assessment of the information available on the subject is needed. The protocol details our proposed methodology for conducting an umbrella review (systematic review of SRMAs) on sex differences related to AMI treatment.

Methods and analysis

An umbrella review will be conducted following the guidelines of the Joanna Briggs Institute. Papers published from database inception until November 25th, 2024, were searched in Ovid Medline, Embase, APA PsycInfo, the Cochrane Database of Systematic Reviews, Epistemonikos and Scopus using controlled vocabulary and text words expressing sex differences AND myocardial infarction. An updated search will be conducted near the end of the umbrella review process to ensure that not recently published SMRAs are missed. No language restrictions will be applied in the database searches, but only SRMAs reported in English will be eligible for inclusion. The inclusion criteria include SMRAs reporting sex differences in outcomes related to AMI treatment among adults. All review steps will be conducted independently by two reviewers. Data will be extracted using a recommended standardised data extraction form. A critical appraisal checklist will be used to assess the risk of bias within the included SMRAs. The findings will be summarised through narrative synthesis using text and tables.

Ethics and dissemination

Ethics approval is not required, as this review will use publicly available data. The results will be disseminated as a peer-reviewed journal article and through national/international conferences.

Trial registration number

PROSPERO, CRD42024561159.

Free school meals, diet quality and food insecurity in secondary school students: protocol for a multiple-methods study - the CANTEEN study

Por: Alving-Jessep · E. · Pallan · M. · Ansell · E. · Hamill · L. · McConnell · C. · McIlwee · D. · McKinley · M. C. · Moore · S. E. · Murphy · M. · Neville · C. · ONeill · C. · Sevel · E. · Adab · P. · Bryant · M. · Chambers · S. · Cardwell · C. R. · Ensaff · H. · Evans · C. · Reid · S. · Holfor
Introduction

Food insecurity is increasing in the UK, impacting choice and diet quality. The current means-tested free school meals (FSM) policy was put in place to address dietary inequalities and food insecurity in school children. In secondary schools, approximately 20% of students who are eligible and registered do not take their FSM. Working across a range of schools that have variable levels of FSM uptake, this study aims to evaluate the effectiveness and cost-effectiveness of the current means-tested FSM policy in UK secondary schools on diet and food insecurity outcomes, understand what factors are associated with uptake and test the potential impact of any proposed policy change.

Secondary schools (n=32) in both Northern Ireland and the Midlands region of the UK are being recruited into the study. Data will be collected from school staff, governors, students and parents via questionnaires, as well as observational data of school eating environments. Qualitative data will be collected in selected case study schools (n=6–8). Multilevel modelling will be undertaken to evaluate the association between FSM uptake and fruit and vegetable intake, overall diet quality and food insecurity in all students. Economic evaluation will be conducted using a cost–utility approach. The effect of policy change will be modelled and school factors associated with FSM uptake explored using multiple methods.

Ethics and dissemination

Ethical approval has been obtained from Queen’s University Belfast Faculty of Medicine, Health and Life Sciences Research Ethical Committee (MHLS 23_55). Findings will be disseminated to key national and local agencies, to schools through reports and presentations, and to the public through media and open access publications.

Effects of government health and immunisation financing on routine childhood vaccination during the COVID-19 pandemic: a difference-in-differences study

Por: Lee · D. · Kim · T. T. · Griffiths · U. · Seidel · M. · Freitas Attaran · M. · Lavayen · M. C. · Cabrera-Clerget · A.
Objectives

To evaluate the safeguarding impact of government commitment (defined as the proportion of government expenditure relative to total expenditure) to health and immunisation financing in mitigating the disruptions to routine childhood vaccination during the COVID-19 pandemic.

Design

A quasi-experimental difference-in-differences study with country fixed effect, leveraging the COVID-19 pandemic as a natural experiment.

Setting

Low-income and middle-income countries.

Participants

A cohort of 131 low- and middle-income countries from 2010 to 2023.

Primary outcome measures

Our primary outcomes included the coverage rates for the third dose of the diphtheria-tetanus-pertussis containing vaccine (DTP3) and the first dose of the measles containing vaccine (MCV1).

Results

Both high government commitment countries (ie, above the upper 20th percentile) and low government commitment countries (ie, below the upper 20th percentile) experienced declines in immunisation coverage over the 4 years following the COVID-19 pandemic, with DTP3 and MCV1 decreasing by 4 and 5 percentage points, respectively (p

Conclusion

Greater government commitment to health and immunisation financing may not be sufficient on its own to mitigate pandemic-related disruptions in routine childhood vaccination.

Efficacy of a mobile app-based intervention to improve eating behaviours and lifestyle in infants of mothers with metabolic risk factors: study protocol of a randomised controlled trial

Por: Chan · D. · Leong · K. · Ong · C. · Ku · C. W. · Chan · J. K. Y. · Chua · M. C. · Yap · F. · Loy · S. L.
Introduction

Childhood obesity has surged globally, leading to various metabolic comorbidities and increased cardiovascular risks. Early intervention in lifestyle and feeding practices during infancy is crucial to mitigate these risks. This study evaluates the efficacy of a mobile web app-based intervention tool, named the Feeding, Lifestyle, Activity Goals (FLAGs) to promote healthier eating behaviours and lifestyle habits in infants from birth to 12 months.

Methods and analysis

This two-arm randomised controlled trial will enrol 220 caregiver-infant pairs per arm at KK Women’s and Children’s Hospital, Singapore, with recruitment expected from January to December 2025. Eligible participants include women at ≥34 weeks’ gestation or up to 3 days post delivery with pre-pregnancy overweight/obesity (body mass index (BMI) >23 kg/m2) and/or a diagnosis of diabetes. Caregiver-infant pairs will be randomised to the FLAGs intervention or control group. Over 12 months, both groups will receive standard infant care. The intervention group will undergo regular assessments via the FLAGs web app built-in assessment tool, assessing infant feeding practices, sedentary behaviour and physical activity. The intervention group will also receive FLAGs personalised guidance and weekly digital nudges. Maternal and infant data will be collected at baseline and at 12 months. Primary outcomes are infant BMI, weight-for-length and body composition at 12 months. Secondary outcomes include lifestyle behaviours and eating habits assessed through validated questionnaires when the infants are 1 year old. We will perform both intention-to-treat and per protocol analysis.

Ethics and dissemination

Ethical approval has been obtained from the SingHealth Centralised Institutional Review Board (Ref: 2024/3224). Written informed consent will be obtained from all participants. Study findings will be disseminated via peer-reviewed publications and academic conferences, with de-identified data available on reasonable request. This trial is registered on ClinicalTrials.gov (ID: NCT06457750).

Trial registration number

NCT06457750.

Protocol for an observational cohort study integrating real-world data and microsimulation to assess imaging surveillance strategies in stage I-IIIA NSCLC patients in OneFlorida+

Por: Braithwaite · D. · Karanth · S. D. · Bian · J. · Meza · R. · Jeon · J. · Tammemagi · M. · Wheeler · M. · Cao · P. · Rackauskas · M. · Shrestha · P. · Yoon · H.-S. · Borondy Kitts · A. · Verma · H. · Blair · M. C. · Chen · A. · Das · D. · Lou · X. · Wu · Y. · Han · S. · Hochhegger · B. · Guo · Y
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Changes in prescription patterns of antidiabetic medication in patients newly diagnosed with type 2 diabetes in Spain: an observational study

Por: Cea-Soriano · L. · Moreno · A. · Calonge · M. · Rivas · A. · Pulido-Manzanero · J. · Colchero · M. C. · Artola · S. · Serrano · R. · Franch-Nadal · J. · Regidor · E. · the PRECOZIN Study Group · Adan · Almanzar · Alonso · Alonso · Alonso · Alvarez · Alvarez · Amoros · Araujo · Arbide
Objective

To estimate the frequency of antidiabetic prescriptions in type 2 diabetes mellitus (T2DM) in Spain and describe changes in prescription patterns between 2018–2022 and 2023-2024.

Design

Observational study.

Participants

Patients from primary care centres newly diagnosed with T2DM in 2018–2022 and 2023–2024.

Primary and secondary outcomes

In each period, the prescription frequency of an antidiabetic medication at the diagnosis of T2DM was calculated and subsequently subdivided into monotherapy and combination therapy. The prescription frequency of the most common antidiabetic drugs was also calculated. Calculations were made for the entire group of subjects and stratified by sex and age (under 60 years and 60 years or older). Comparison of the frequencies between the two periods was performed using the chi-square test.

Results

In 2018–2022 and 2023–2024, 78.4% and 88.9% of patients, respectively, were prescribed an antidiabetic medication. The prescription frequencies for monotherapy and combination therapy were 66.1% and 33.9% in the first period and 57.4% and 42.6% in the second. The prescription frequencies for metformin as monotherapy and combination therapy were 57.4% and 27.8% in the first period and 46.6% and 39.8% in the second. Prescribing metformin with sodium-glucose cotransporter-2 inhibitors (SGLT2i) and/or glucagon-like peptide receptor 1 agonists (GLP1a) was the most frequent combination therapy: 12.8% in 2018–2022 and 29.5% in 2023–2024. With a few exceptions, the prescribing pattern was similar by sex and age. The difference between the prescribing distributions in the two periods is significant.

Conclusion

Antidiabetic medication prescribing at the diagnosis of T2DM was high. Most prescriptions contained metformin. Monotherapy decreased in 2023–2024 compared with 2018–2022, while combination therapy increased due to increased prescriptions of metformin with SGLT2i and/or GLP1a.

Evaluating a population-based screening programme for early detection of liver fibrosis and cirrhosis in primary care in Germany: a cost assessment study

Por: Ortner · J. · Van Ewijk · R. · Velthuis · L. · Labenz · C. · Arslanow · A. · Nguyen-Tat · M. · Wörns · M.-A. · Reichert · M. C. · Farin-Glattacker · E. · Binder · H. · Fichtner · U. A. · Graf · E. · Stelzer · D. · Galle · P. R. · Lammert · F.
Objectives

Structured Early detection of Asymptomatic Liver fibrosis and cirrhosis (SEAL) is a population-based screening programme using non-invasive tests for the early detection of liver fibrosis. This study evaluates the cost implications if the SEAL programme were to be implemented in routine care in Germany.

Design

This study models cost differences with and without the SEAL screening programme. We regress costs of care on patient characteristics (age, comorbidities, sex, liver diseases, liver cancer and liver fibrosis and cirrhosis (LCI) stage) using statutory health insurance (SHI) data from routine care patients with LCI (n=4177). Based on these results, we predict per-patient costs for the patients newly diagnosed with LCI by SEAL (n=45). Costs with and without screening are estimated using patient age and LCI stage distributions from either SEAL or routine care.

Setting

SEAL was conducted in two German states. Initial screening was performed by patients’ primary care physicians.

Participants

Individuals insured by SHI without a prior diagnosis of LCI, eligible for Check-up 35, a general health check-up programme primarily targeting adults aged 35 and older, conducted by primary care physicians.

Interventions

Screening via aspartate aminotransferase to platelet ratio index in primary care, for further evaluation serological diagnostics and ultrasound examinations in secondary care and specific assessment for definite diagnosis including transient elastography and liver biopsy for selected cases in tertiary care.

Primary and secondary outcome measures

Primary outcome measures: expected 5-year cost changes for SEAL patients diagnosed with fibrosis or cirrhosis compared to costs without a screening programme. Secondary outcome measures: case mix of leading chronic liver disease and LCI stages among patients diagnosed with advanced fibrosis or cirrhosis in SEAL versus routine care without screening.

Results

Screening leads to fewer decompensated cases at initial diagnosis (4.6% in SEAL vs 22.8% in routine care) and thus savings in the costs of care within the first years of diagnosis: total expected costs per case were 2175 lower (bias-corrected bootstrap CIs (BCI): 527 to 3734), and LCI-associated costs were reduced by 1218 (BCI: 296 to 2164). Comparing the savings to the additional costs of diagnosis (range: 1575–1726 per detected LCI case) reveals that average changes in costs with screening range from moderate savings to moderate extra costs.

Conclusions

SEAL liver screening identifies patients in less advanced stages of LCI. If only costs were considered that are directly attributable to LCI, savings within 5 years are unlikely to fully outweigh the costs of screening. However, since this approach might miss additional LCI-related costs, SEAL appears to be cost-neutral compared with routine care when considering total healthcare costs.

Registration number

The SEAL registration number is DRKS00013460. This study relates to its results.

Efficacy of virtual reality in reducing pain, anxiety and fear in hospitalised children: a systematic review and meta-analysis protocol

Introduction

Paediatric hospitalisation, encompassing the period from admission to discharge, often involves feelings of pain, fear and anxiety, primarily due to clinical diagnoses and, more significantly, discomfort and stress-inducing procedures. Numerous methodologies and interventions have been investigated and implemented to alleviate these phenomena during paediatric hospitalisation. Virtual reality (VR), for example, has demonstrated efficacy in pain relief for hospitalised children in recent studies. This systematic review, therefore, aims to identify and evaluate the effectiveness of VR in alleviating pain, fear and anxiety in hospitalised children undergoing painful procedures.

Method and analysis

This systematic review and meta-analysis will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols guidelines. A systematic search will be conducted in March and April 2025 across the following databases, with no restrictions on language or publication year: PubMed, Embase, Scopus, Web of Science, Cumulated Index in Nursing and Allied Health Literature, ClinicalTrials.gov and the Cochrane Central Register of Controlled Trials. Eligible studies will include randomised and quasi-randomised clinical trials involving children (aged 2–10 years) and adolescents (aged 10–18 years) who received VR interventions during painful procedures. Data will be managed and analysed using Review Manager software (RevMan 5.2.3). In cases of significant heterogeneity (I² > 50%), a random-effects model will be employed to combine studies and calculate the OR with a 95% CI. The methodological quality of the included studies will be assessed using the Cochrane Risk of Bias 2.0 tool, and the certainty of the evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluations framework.

Ethics and dissemination

This study will solely review published data; thus, ethical approval is not required. This systematic review is expected to provide subsidies, evidence and insights into the use of VR. It is also anticipated that the results will directly impact the improvement of care for these patients and the qualification of professional care.

PROSPERO registration number

CRD42024568297.

Development and psychometric evaluation of a new self-report measure to assess patient engagement behaviours and capacity in the USA: the Patient Engagement Capacity Survey

Por: Gregory · M. E. · Sieck · C. J. · Walker · D. M. · Di Tosto · G. · Edwards · M. C. · McAlearney · A. S. · Gebretsadik · S. · DeVos · T. V. · Hefner · J. L.
Objective

Patient engagement (PE), or a patient’s participation in their healthcare, is an important component of comprehensive healthcare delivery, yet there is not an existing, publicly available, measurement tool to assess PE capacity and behaviours. We sought to develop a survey to measure PE capacity and behaviours for use in ambulatory healthcare clinics.

Design

Measure development and psychometric evaluation.

Setting and participants

A total of 1180 adults in the USA from 2022 to 2024, including 1050 individuals who had indicated they had seen a healthcare provider in the prior 12 months who were recruited nationally via social media across three separate samples; 8 patient advisors and healthcare providers recruited from a large, midwestern US Academic Medical Center; and 122 patients recruited from five participating ambulatory clinics in the Midwestern USA.

Methods

An initial survey was developed based on a concept mapping approach with a Project Advisory Board composed of patients, researchers and clinicians. Social media was then used to recruit 540 participants nationally (Sample 1) to complete the initial, 101-item version of the survey to generate data for factor analysis. We conducted exploratory and confirmatory factor analyses to assess model and item fit to inform item reduction, and subsequently conducted cognitive interviews with eight additional participants (patient advisors and providers; Sample 2), who read survey items aloud, shared their thoughts and selected a response. The survey was revised and shortened based on these results. Next, a test–retest survey, also administered nationally via another round of social media recruitment, was administered two times to a separate sample (n=155; Sample 3), 2 weeks apart. We further revised the survey to remove items with low temporal stability based on these results. For clinic administration, research staff approached patients (n=122; Sample 4) in waiting rooms in one of five ambulatory clinics to complete the survey electronically or on paper to determine feasibility of in-clinic survey completion. We engaged in further item reduction based on provider feedback about survey length and fielded a final revised and shortened survey nationally via a final round of social media recruitment (n=355; Sample 5) to obtain psychometric data on this final version.

Primary and secondary outcome measures

Cronbach’s alphas, intraclass correlations (ICCs), Comparative Fit Index (CFI), root mean square error of approximation (RMSEA), standardised root mean squared residual (SRMR).

Results

The final PE Capacity Survey (PECS) includes six domains across two scales: ‘engagement behaviours’ (ie, preparing for appointments, ensuring understanding, adhering to care) and ‘engagement capacity’ (ie, healthcare navigation resources, resilience, relationship with provider). The PECS is 18 questions, can be completed during a clinic visit in less than 10 minutes, and produces scores which demonstrate acceptable internal consistency reliability (α=0.72 engagement behaviours, 0.76 engagement capacity), indicating items are measuring the same overarching construct. The scales also had high test–retest reliability (ICC=0.82 behaviours, 0.86 capacity), indicating stability of response over time, and expected dimensionality with high fit indices for the final scales (behaviours: CFI=0.97; RMSEA=0.07; SRMR=0.05; capacity: CFI=0.99; RMSEA=0.06; SRMR=0.06), indicating initial evidence of construct validity.

Conclusions

The PECS is the first known measure to assess patients’ capacity for engagement and represents a step toward informing interventions and care plans that acknowledge a patient’s engagement capacity and supporting engagement behaviours. Future work should be done to validate the measure in other languages and patient populations, and to assess criterion-related validity of the measure against patient outcomes.

Factors influencing HPV vaccine acceptance in immunosuppressed patient populations: a protocol for a systematic review

Introduction

The development of effective vaccines targeting human papillomavirus (HPV) has significantly contributed to disease prevention, highly relevant in immunosuppressed patients who have higher incidence of HPV-related cancers than their non-immunosuppressed counterparts. However, the acceptance and uptake of the HPV vaccine among immunosuppressed individuals pose unique challenges. Immunocompromised patients’ acceptance of the HPV vaccine is influenced by multifaceted factors, including concerns about safety and effectiveness, interactions with immunosuppressive medications and uncertainties due to their compromised immunity. This systematic review aims to identify the main factors influencing HPV vaccine acceptance among immunosuppressed patients.

Methods and analysis

A comprehensive search strategy will be executed across databases such as MEDLINE/PubMed, Embase, Scopus, Web of Science, ScienceDirect, Latin American and Caribbean Literature in Health Sciences, Cumulative Index to Nursing and Allied Health Literature and Cochrane Database. The review will encompass the three WHO-endorsed HPV vaccines (quadrivalent, bivalent and nonavalent) and will consider studies related to HPV vaccines and their administration. The scope includes study focusing on immunosuppressed patients who received organ transplants, cancer treatments or are HIV-positive. No temporal restrictions will be applied, and searches will be conducted until December 2025. Observational studies, including retrospective/prospective cohorts, case–control and cross-sectional studies, reporting factors influencing HPV vaccination in immunosuppressed populations will be included. Studies with overlapping patient populations will be excluded. Data extraction will include study details, demographics, vaccine type, risk/protective factors, outcomes and medical history. Validation and cross-verification will ensure data accuracy. Risk of bias will be assessed using ROBINS-I (Risk Of Bias In Non-randomised Studies of Interventions), and GRADE (Grading of Recommendations Assessment, Development and Evaluation) will rate evidence certainty. Meta-analysis, guided by Cochrane and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, will employ fixed/random-effects models, assessing heterogeneity using I² statistics.

Ethics and dissemination

This research will analyse previously published data, so ethical approval is not required. The results of the systematic review will be submitted for publication in a peer-reviewed journal.

PROSPERO registration number

CRD42023452537.

Two years and counting: a prospective cohort study on the scope and severity of post-COVID symptoms across diverse patient groups in the Netherlands--insights from the CORFU study

Por: Klein · D. O. · Waardenburg · S. F. · Janssen · E. B. N. J. · Wintjens · M. S. J. N. · Imkamp · M. · Heemskerk · S. C. M. · Birnie · E. · Bonsel · G. J. · Warle · M. C. · Jacobs · L. M. C. · Hemmen · B. · Verbunt · J. · van Bussel · B. C. T. · van Santen · S. · Kietelaer · B. L. J.
Importance

Little research has been done on post-COVID symptoms at 24 months postinfection and on the association these may have on health-related quality of life (HRQOL).

Objective

We assessed the prevalence and severity of post-COVID symptoms and quantified EuroQol 5 Dimension 5 Level (EQ-5D-5L), self-perceived health question (EuroQol Visual Analogue Scale (EQ-VAS)) and health utility scores (HUS) up to 24 months follow-up.

Design

The longitudinal multiple cohort CORona Follow-Up (CORFU) study combines seven COVID-19 patient cohorts and a survey among the general public. The participants received questionnaires on several time points. Participants were stratified by: without a known SARS-CoV-2 infection (control group), proven SARS-CoV-2 infection but non-hospitalised, proven SARS-CoV-2 infection hospitalised to the ward, and proven SARS-CoV-2 infection hospitalised to the intensive care unit (ICU).

Setting

In this study, data of seven COVID-19 patient cohorts and a survey among the general public are included.

Participants

Former COVID-19 patients and controls participated in this cohort study.

Main outcomes and measures

Former COVID-19 patients and non-COVID-19 controls were sent questionnaires on symptoms associated with post-COVID condition. The CORFU questionnaire included 14 symptom questions on post-COVID condition using a five-level Likert-scale format. Furthermore, HRQOL was quantified using the EuroQol EQ-5D-5L questionnaire: EQ-VAS and the EQ-5D-5L utility score. The EQ-5D-5L questionnaire includes five domains that are scored on a five-point Likert scale: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

Results

A total of 901 participants (and 434 controls) responded at 24 months follow-up. In all former COVID-19 patients, the presence of post-COVID condition at 24 months was observed in 62 (42.5%, 95% CI 34.3% to 50.9%) of the non-hospitalised patients, 333 (65.0%, 95% CI 60.7% to 69.2%) of the hospitalised ward patients and 156 (63.2%, 95% CI 56.8% to 69.2%) of the ICU patients, respectively (p

Conclusions

Many former COVID-19 patients experience post-COVID symptoms at 24 months follow-up, with the highest prevalence in hospitalised participants. Also, former patients reported a lower HRQOL.

Trial registration number

The CORFU study was registered at clinicaltrials.gov (registration number NCT05240742).

Effectiveness of aromatherapy in pain relief postcardiac surgery: a systematic review and meta-analysis protocol

Introduction

Acute pain in the postoperative period of cardiac surgery is mostly treated with opioid analgesics. However, with the risk of adverse reactions and complications, strategies which do not involve opioid analgesics can be considered, such as aromatherapy. This systematic review aims to analyse the effectiveness of aromatherapy in relieving pain in post-cardiac surgery patients.

Methods and analysis

Two researchers will independently and simultaneously conduct searches and select studies from the following databases: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Latin American and Caribbean Literature on Health Sciences, Scopus, Web of Science, Cochrane (Library) and clinical trial registries (clinicaltrials.com), with no language or publication date restrictions. Randomised and quasi-randomised clinical trials on the use of aromatherapy for pain relief in postcardiac surgery patients will be included. Then, two researchers will independently examine the studies based on inclusion criteria, extract data from the included studies and assess the risk of bias using the Risk of Bias 2 tool and the Risk of Bias in Non-randomized Studies of Interventions tool from Cochrane. Data will be synthesised using Review Manager software. The strength of the evidence will be evaluated using the Grading of Recommendation Assessment, Development and Evaluation approach. The literature search, study selection, review and meta-analysis stages will be conducted from early October 2025 to April 2026.

Ethics and dissemination

This study is based on secondary data, and therefore ethical approval from a research ethics committee was not required. The results will be disseminated through publication in a peer-reviewed scientific journal.

PROSPERO registration number

CRD42024568532.

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