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Associations of perceived family economy, registry-based parental education and income with adolescent psychological distress: the Young-HUNT cross-sectional studies 2006-2008 and 2017-2019

Por: Selvik · K. L. I. · Strandas · B. M. E. · Olsson · C. A. · Braaten · T. · Bjerkeset · O.
Objectives

This study aimed to investigate the associations of adolescents’ self-reported family financial stress, registry-based parental household income and parental education with adolescent anxiety and depression symptoms. Additionally, we adjust these associations for parental anxiety and depression symptoms and examine potential secular changes in these associations.

Design

Family linkage study, using two cross-sectional population-based health studies, the Young-HUNT study and the HUNT study. Registry-based data from Statistics Norway (SSB).

Setting

Northern part of Trøndelag County, Norway.

Participants

Adolescent (aged 13–19 years) participating in The Young-HUNT3 Survey (2006–2008, n=8199) and The Young-HUNT4 Survey (2017–2019, n=8066) and their parents participating in The HUNT3 Survey (2006–2008, n=50 800) and the HUNT4 Survey (2017–2019, n=56 042).

Measurements

Adolescent anxiety and depression symptoms were assessed by a short version of the Hopkins Symptom Checklist (HSCL), the five-item HSCL-5. Self-reported family financial stress was measured using a single-item question. Parental anxiety and depression were assessed by the 14-item Hospital Anxiety and Depression Rating Scale (total HADS score). Parental income and parental education were obtained from SSB. We use a multilevel mixed-effects generalised linear model.

Results

Adolescents who perceived their family financial stress as worse than others reported a higher SCL-5 total score compared with those with self-perceived average financial stress. The relative differences ranged from 1.16 (95% CI 1.09 to 1.23) in boys to 1.24 (95% CI 1.17 to 1.31) in girls. In contrast, little or no association was found between parental registry-based income or educational level and adolescents’ mean SCL-5 total scores. Adjusting for parental HADS scores did not alter the estimates. With a few exceptions for girls, there was no evidence for a secular change in these associations.

Conclusion

Self-perceived family financial stress, but not registry-based parental income and education, was associated with elevated anxiety and depression symptom levels in adolescents, and findings were essentially the same in Young-HUNT3 and Young-HUNT4. These findings underscore the importance of incorporating multiple measures of socioeconomic status when investigating socioeconomic inequalities in adolescent mental health.

Values and preferences of patients with severe mental illness regarding smoking cessation interventions: a systematic review with best-fit framework synthesis

Por: Coteur · K. · Tops · L. · Bekkering · G. E. · de Almeida Ferreira Fonseca · L. · van den Brand · F. · Cloetens · H. · Zeng · L. · Aertgeerts · B. · Delvaux · N. · Agarwal · A. · Agoritsas · T. · Vermandere · M.
Objective

To identify values and preferences regarding smoking cessation interventions among adults with severe mental illness

Design

Systematic review with best-fit framework synthesis

Data sources

MEDLINE, EMBASE, Web of Science, CINAHL and Scopus from inception to 14 November 2025.

Study selection

Studies with any design, in any clinical and geographical setting, reporting on adult (18+) current or past smokers with a diagnosis of schizophrenia, bipolar or mood disorder, including major depressive disorder or post-traumatic stress disorder. We selected all quantitative and qualitative findings regarding patients’ values and preferences, including beliefs, attitudes, behaviours and perceived barriers and facilitators, in relation to smoking cessation interventions.

Data extraction and synthesis

Two reviewers independently screened studies. After a pilot to increase accuracy, data were extracted by one reviewer and verified by another. Risk of bias was assessed using the Mixed Methods Appraisal Tool. We used the best-fit framework synthesis methodology to synthesise the data.

Results

Of 14 970 identified articles, 65 were included. Most studies were of moderate to high quality. Financial costs posed a significant barrier, while education and social support emerged as important facilitators. Patients preferred personal interactions with healthcare providers. Their motivation for cessation varied and was influenced by habits and perceived nicotine dependence. Health concerns and financial savings were primary drivers for reflective motivation. Beliefs regarding treatment varied. Although commonly used, scepticism about nicotine replacement therapy and concerns about the long-term safety of electronic delivery systems were reported. Overall, patients preferred personalised, flexible programmes and emphasised the need for tailored approaches. Digital interventions, especially mobile apps, that provide support, motivational content and relevant information, were perceived as appealing and helpful when sufficiently considering accessibility and usability aspects. Patients commonly perceived smoking as a coping mechanism for negative emotions. Developing new coping strategies and creating smoke-free environments were deemed to contribute to successful cessation.

Conclusions

Patient-centred care for people with severe mental illness should leverage behavioural and pharmacological strategies for smoking cessation. Flexibility, accessibility and ongoing support appeared important for addressing stress, withdrawal symptom interpretation and relapse vulnerability in this population.

PROSPERO registration number

CRD42022337933.

Suicides, suicide attempts and suicidal ideation among children and young people exposed to war: a scoping review

Por: Silwal · S. · Westerlund · M. · Wan Mohd Yunus · W. M. A. · Jaakola-Siimes · S. · Klomek · A. B. · Sourander · A.
Objectives

Worldwide, billions of children and young people live in areas affected by war. Suicide remains one of the three leading causes of death worldwide among people aged 15–29 years. However, little is known about the effect of war on suicidal behaviours in this group. This review aims to assess suicides, suicide attempts and suicidal ideation among children and young people exposed to war or armed conflict.

Design

A scoping review of studies was conducted using Web of Science, PubMed, Embase and PsycINFO databases from their inception to 18 November 2025, without any restrictions on geographical location. We included only observational studies with full-text, peer-reviewed English articles reporting any suicides, suicide attempts and suicidal ideation of children and young people aged 0–24 years exposed to war. The quality of the included articles was assessed using the Quality Assessment with Diverse Studies. The protocol of the review was registered with the Open Science Framework on 29 March 2022 (https://osf.io/7kszh/).

Results

Of the 3229 articles retrieved, 37 studies were eligible for review, providing data from 24 countries and covering a period of almost a hundred years (1921–2025). Most studies (>20) focused on conflicts ongoing during or until the 2000s, whereas only three focused on World War II. The reported outcomes were suicides (n=9), suicide attempts (n=15) and suicidal ideation (n=21). Included studies spanned six continents, from Latin America (n=5, Colombia only) to Europe (n=10). We assessed the suicide rates during and after wars. There was some evidence of a decrease in suicide rates during war, but no clear trend in suicide rates post-war was observed. The prevalence rates of suicide attempts and suicidal ideation varied widely, without uniformity in the definitions used. War-related trauma, mental health problems, substance abuse and exposure to suicide or suicide attempts were identified as risk factors, while protective factors included family and social support.

Conclusions

There is a need for more methodologically consistent and rigorous research on suicidal thoughts and behaviours in children and young people exposed to war or armed conflicts. Future research should identify mediator/moderating factors influencing suicidal behaviours and their links to mental health.

The benefits and costs of domiciliary care: a study protocol for evaluating the cost-effectiveness of domiciliary care in England

Por: Vadean · F. · Mamolis · G. · Rand · S. · Gousia · K. · Teo · H. · Birch · S. · Alvarez Nishio · A. · Towers · A.-M. · Allan · S. · Darton · R. · Gregory · F. · Lambert · C. · Fenton · W. · Davison · S. · Roberts · A. · Nizalova · O.
Introduction

Care provided in people’s own homes (domiciliary care) is an increasingly important part of long-term care. There are various services, including home visits, live-in care and housing with care. Some people directly employ care staff, called personal assistants. Services vary in quality, price and availability, and there is currently little evidence of the value these services provide to the public purse and individuals. This study protocol presents planned research to fill this important gap.

Methods and analysis

This will be a cross-sectional study based on surveys of care recipients, their unpaid carers as well as formal care providers. In the first half of 2026, we will survey 1850 people accessing domiciliary care either through a homecare agency, a housing with care scheme or by directly employing personal assistants and 400 unpaid carers, all based in England. We will conduct a cost-effectiveness analysis taking a ‘production function’ approach and use quality of life as measured by the Adult Social Care Outcomes Toolkit as the main outcome of interest.

Ethics and dissemination

The study received ethical approval from the School of Social Sciences Staff Review Committee at the University of Kent on 20 May 2025 (reference 1195) and the Health Research Authority, London—Camberwell St Giles Research Ethics Committee on 28 October 2025 (reference 25/LO/0652). Implications around consent, data protection and confidentiality, risk and participant payment are discussed. In addition to academic outputs (eg, academic articles, conference presentations), we aim to coproduce news items and blogs with people with lived experience of accessing long-term care and jointly present findings at events aimed at the care sector. Moreover, we will offer participating care providers benchmarking briefs based on our findings.

Womens preference for HPV self-sampling devices: a programme-embedded, large-scale paired comparative study within the cervical cancer screening programme in the Capital Region of Denmark

Por: Andreasen · E. K. · Arum · A. · Pedersen · H. · Dahl Nielsen · T. · Frandsen · P. · Pedersen · B. T. · Serizawa · R. · Bonde · J.
Objective

To demonstrate women’s preferences for three human papillomavirus (HPV) self-sampling devices.

Design

Cross-sectional, programme-embedded paired comparative study with randomised sampling order within device pairs.

Setting

Organised cervical cancer screening programme in the Capital Region of Denmark.

Participants

1760 women eligible for cervical cancer screening (April 2024 to May 2025), assigned to one of three groups: (1) Evalyn versus FLOQSwab (n=518), (2) Evalyn versus SensiGrip (n=657) and (3) FLOQSwab versus SensiGrip (n=585).

Outcome measures

Primary: device preference. Secondary: sampling-experience (self-reported). Data were assessed with ² tests for preference, logistic regression for predictor analysis and Wilcoxon signed-rank equivalence test with two one-sided test procedures to assess sampling experience.

Results

Overall, 95.7% rated HPV self-sampling a positive experience and 87.3% preferred HPV self-sampling in future screening. SensiGrip was preferred significantly over FLOQSwab (p0.05) although Evalyn scored higher in sampling certainty. Sampling order influenced preference in Evalyn comparisons. Prior experience with self-sampling, screening history and subcohort membership did not significantly influence device preference.

Conclusions

Overall, participants rated self-sampling a positive experience. SensiGrip was preferred over FLOQSwab, while Evalyn demonstrated comparable overall acceptability to both alternative devices in the primary implementation-focused analysis. These findings suggest that device replacement would be acceptable from a screening participation perspective, particularly a shift from FLOQSwab to SensiGrip.

Socioeconomic disparities and mortality among acute patients with sepsis: a retrospective Danish cohort study

Por: Schade Skov · C. · Brabrand · M. · de Groot · B. · Rosenvinge · F. S. · Skjot-Arkil · H. · Mogensen · C. B. · Johansen · I. S. · Lassen · A. T.
Objectives

Socioeconomic inequalities exist in infectious diseases and sepsis in high-income countries. We investigated the association between income and mortality among patients with sepsis, overall and among those treated in the intensive care unit (ICU) versus general wards.

Design

A retrospective register-based cohort study.

Setting

The Region of Southern Denmark (RSD).

Participants

All adult patients with an unplanned contact with a hospital in the RSD from 1 January 2016 to 20 March 2018. Patients with sepsis were identified based on the following criteria: (1) blood culture(s) performed within 48 hours of arrival, (2) antibiotic(s) administered within 48 hours of arrival, (3) a discharge diagnosis of infection and (4) a SOFA (Sequential Organ Failure Assessment) score of ≥2. The cohort was divided into quartiles according to household income.

Primary and secondary outcome measures

Cox proportional hazards models were used to estimate the association between income groups and mortality. The primary outcome was 90-day mortality with 7-day and 365-day mortality as secondary outcomes. All outcomes were calculated overall and stratified by general ward treatment only and ICU admission.

Results

We identified 7813 first-time visits with community-acquired sepsis, including 886 ICU admissions (11.3%). Among patients in the lowest income group, sepsis was associated with a HR of 1.16 (95% CI 1.01 to 1.34) for 90-day mortality compared with the highest income group. This association was particularly pronounced at 365-day follow-up: HR=1.24 (95% CI 1.10 to 1.39). No difference was observed in 7-day all-cause mortality, HR=1.13 (95% CI 0.89 to 1.45). The association was not observed among patients admitted to the ICU.

Conclusion

Low income was associated with increased mortality in patients with sepsis, particularly during long-term follow-up. The impact of income disparities was not observed among patient admitted to the ICU.

N-terminal proBNP adds prognostic value to high-sensitivity cardiac troponin I in elective thoracic surgery: an observational cohort study

Por: Alonso · M. · Popova · E. · De Miguel · M. · Garcia-Osuna · A. · Gonzalez-Tallada · A. · Ordonez-Llanos · J. · Jauregui · A. · Trujillo · J. C. · Martin Grande · A. · Martinez-Tellez · E. · Parera · A. · Planas · G. · Trujillo · L. · Butron · D. · Sola-Roca · J. · De Nadal · M.
Background

Perioperative myocardial injury (PMI) is a common complication following non-cardiac, particularly thoracic, surgery and is associated with increased cardiovascular risk. Although guidelines recommend cardiac biomarker monitoring to detect PMI, its implementation in routine clinical practice remains limited.

Objective

To evaluate the combined use of high-sensitivity cardiac troponin I (hs-cTnI) and N-terminal pro-brain natriuretic peptide (NT-proBNP) in predicting major adverse cardiovascular events (MACE) following elective thoracic surgery, and to determine whether NT-proBNP provides incremental prognostic value beyond hs-cTnI alone.

Design

Multicentre observational cohort study.

Setting

Conducted between February 2021 and November 2023 in three Spanish tertiary hospitals.

Participants

Patients aged ≥45 years scheduled for elective thoracic surgery involving lung resection (pneumonectomy, lobectomy, bilobectomy or segmentectomy) under general anaesthesia. Exclusion criteria included urgent or non-thoracic surgery, active infection or sepsis and a history of severe heart failure (ejection fraction

Main outcome measures

Combined measurement of hs-cTnI and NT-proBNP at baseline (preoperatively) and at 24 and 48 hours postoperatively.

PMI was defined as hs-cTnI ≥45 ng/L at 24 and/or 48 hours or a ≥20% increase from baseline in patients with elevated preoperative concentrations.

Results

Among 475 patients, PMI occurred in 11.8%. PMI had higher rates of prior stroke (12.5% vs 2.9%; p=0.004), smoking history (85.7% vs 64.0%; p=0.001) and severe renal dysfunction (7.1% vs 0.7%; p=0.001), with similar Revised Cardiac Risk Index distribution. Patients with PMI also had greater postoperative elevations of hs-cTnI and NT-proBNP (p

Conclusions

Combined hs-cTnI and NT-proBNP assessment improves perioperative cardiovascular risk stratification beyond ischaemia.

Trial registration number

NCT04749212

Occupational biomechanical risk factors for hip and knee arthroplasty incidence: a register-based cohort study in male construction workers

Por: Gustafsson · K. · Wahlström · J. · Stjernbrandt · A. · Lewis · C. · Mukka · S. · Liv · P. · Noor Baloch · A.
Objective

To evaluate the association between exposure to occupational biomechanical factors and the incidence of surgically treated osteoarthritis (OA) treated with arthroplasty in the hip and knee among male construction workers.

Design

Longitudinal register-based cohort study.

Participants and setting

Male construction workers (n=291 062) who participated in a national Swedish occupational health examination programme between 1971 and 1993, delivered through multiple primary-level nationwide occupational health centres.

Primary and secondary outcome measures

Hip and knee arthroplasties performed due to OA from 1987 to 2019 were identified through linkage with the Swedish National Patient Register. Data on age, smoking habits, body mass index, job title and self-reported biomechanical exposures were collected during the health examinations. Occupational biomechanical workload was assessed using eight factors from a job-exposure matrix. Poisson regression was applied to estimate adjusted incidence rate ratios (IRRs) associated with each type of occupational biomechanical exposure.

Results

The study included 10 336 cases of hip arthroplasties and 8926 cases of knee arthroplasties. All studied biomechanical risk factors were associated with an increased risk of knee OA requiring arthroplasty, especially for individuals exposed to static work in non-neutral lumbar postures (IRR 1.38, 95% CI 1.16 to 1.65) and those with a high frequency of kneeling (IRR 1.27, 95% CI 1.12 to 1.45). In contrast, only a few biomechanical factors were associated with an increased risk of hip OA requiring arthroplasty. Similar results were observed when alternative exposure measures, such as occupational group and self-reported exposure assessments, were employed.

Conclusions

Occupational workload was associated with an increased risk of knee arthroplasty due to OA, whereas the association for hip arthroplasty remains unclear.

Factors influencing dentists choice of restorative materials for occlusal cavities: a cross-sectional study from Palestine

Por: Arandi · N. Z.
Objective

To assess the factors influencing dentists’ choice of restorative materials for posterior restorations, with a particular emphasis on the perceived influence of social media on patient preferences among general dental practitioners in Palestine.

Design

Cross-sectional web-based survey.

Participants/Setting

A total of 550 general dentists practising in Palestine were invited between May and December 2023 through convenience and snowball sampling via social media platforms; 390 responded, and 350 complete responses were included in the final analysis.

Intervention

No specific intervention was applied; this was an observational, questionnaire-based study.

Main outcome measures

Dentists’ selection of restorative materials (composite, amalgam or high-viscosity glass-ionomer cement (HVGIC)) for posterior restorations in relation to tooth type, patient age, oral hygiene, moisture control, financial status and social media influence.

Statistical analysis was performed

Descriptive statistics, ² tests and multinomial logistic regression were used to examine associations and control for potential confounders.

Results

Material selection varied significantly by tooth type (p

Conclusion

Patient-related factors were the main determinants of material selection, whereas practitioner demographics played a minimal role. HVGICs are preferred for paediatric and elderly patients because of their suitability for age-specific clinical needs. The influence of social media, assessed in this study as dentists’ perceptions rather than direct measures of patient behaviour, underscores its growing role in shaping dentists’ impressions of patient expectations and highlights the importance of evidence-based guidance and public education to support patient-centred, clinically appropriate restorative decisions.

Strengthening and Targeted Rehabilitation for Optimal Neuromuscular Gains for chronic BACK pain (STRONG-BACK): protocol for a randomised controlled trial in participants with primary nociceptive pain drivers

Por: Fortin · M. · Rosenstein · B. · Bertrand · C. · Vaillancourt · N. · Wright · A. · Montpetit · C. · Macedo · L. · Elliott · J. · Cook · C. E. · Tousignant-Laflamme · Y. · Ma · J. · Page · M. G. · Dover · G. · Dang-Vu · T. T. · Weber · M. H.
Introduction

Exercise therapy is the most recommended treatment for chronic low back pain (LBP), with evidence supporting modest effects, likely due to the heterogeneity of patient presentations. Evidence suggests that matching individuals to the most appropriate exercise type could improve outcomes. Systematic reviews also emphasise that effective exercise interventions should be patient centred, target paraspinal muscle health and be of sufficient duration. This study addresses these gaps using a targeted care approach to identify a homogenous sample that is more likely to respond to our interventions. The inclusion of a sample with predominant nociceptive pain profile will be performed with the integration of the Pain and Disability Drivers Management Model (PDDM) and the Lumbar Spine Instability Questionnaire (LSIQ). The primary aim of this two-arm randomised controlled trial is to compare the effectiveness of motor control plus isolated lumbar extension exercises (MC+ILEX, arm 1) to free-weight resistance training (arm 2) in reducing LBP-related disability. Secondary aims include examining whether changes in multifidus composition mediate disability improvements comparing intervention effects on muscle size and quality, strength, mobility, pain, quality of life, sleep, physical activity and satisfaction; exploring baseline LSIQ scores and sex/gender as moderators of treatment response; and investigating participants’ perceptions and experiences of exercise therapy.

Methods and analysis

A total of 106 participants will be recruited through primary and secondary care and randomised (1:1) to receive either MC+ILEX or free-weight resistance training. Both groups will complete 48 exercise sessions over 16 weeks. The primary outcome will be disability at 16 weeks, measured by the Oswestry Disability Index. Secondary outcomes include multifidus muscle composition and size, lumbar and gluteal muscle strength, hip range of motion, pain, physical and mental function, satisfaction and recovery, health-related quality of life, sleep quality and physical activity levels. Linear mixed-effects models will be used to assess primary and secondary outcomes. Regression analyses will explore whether baseline LSIQ scores moderate treatment effects on multifidus composition and other outcomes. A subsample of participants will undergo semistructured interviews before and after the intervention to explore their illness perceptions, illness mindsets, perceptions of exercise therapy, as well as their experiences and satisfaction with the two exercise interventions. Reflexive thematic analysis will be used to analyse qualitative data.

Ethics and dissemination

This study received ethics approval from the Central Ethics Research Committee of the Quebec Minister of Health and Social Services (CCER-25-26-14). Results will be submitted to peer-reviewed journals and scientific meetings.

Trial registration number

ISRCTN14864451.

Older adults as active research partners: protocol for an umbrella review

Por: Hedqvist · A.-T. · Strandberg · S. · Holmberg · B. · Niklasson · J. · Violasdotter Nilsson · P. · Carlsson · W. · Andreassen · M. · Bergstrand · S. · Holmberg · M. · Nilsen · C.
Introduction

The involvement of older adults as active partners in research is increasingly being promoted to improve the relevance and impact of scientific knowledge. However, the evidence base on how older adults have been involved as active partners in healthcare research remains fragmented. To our knowledge, no review of reviews has yet provided a comprehensive overview of this body of evidence. Therefore, this umbrella review aims to synthesise review-level evidence on the involvement of older adults as active research partners. We address three questions: (1) How have older adults been involved as active partners in research? (2) What terminology, models and frameworks have been used? (3) What benefits and challenges have been reported related to involving older adults as active partners in research?

Methods and analysis

This study will follow the Joanna Briggs Institute (JBI) methodology for umbrella reviews. A comprehensive search will be conducted in Medline, CINAHL, Scopus, PsycINFO, Sociological Abstracts and Web of Science. Eligible reviews will be those reporting on the involvement of older adults (aged 60 years or older) as active partners in research. Two reviewers will independently screen titles, abstracts and full texts and perform data extraction using a standardised form. Methodological quality will be assessed using the JBI Critical Appraisal Checklist for Systematic Reviews. Findings will be synthesised narratively and thematically, with attention to reported roles, terminology, conceptual frameworks and the benefits and challenges of involvement.

Ethics and dissemination

As this umbrella review draws exclusively on secondary data from published sources, ethical approval is not required. Older adults, engaged as independent public contributors, have been involved in shaping the review protocol and will take part in interpreting the findings. Results will be disseminated through a peer-reviewed journal and presentations at academic and stakeholder conferences, and used to inform the design of a subsequent mixed-methods study focused on strengthening the involvement of older adults as active partners in research.

PROSPERO registration number

CRD420251064947.

Delivering integrated diabetes and mental healthcare for people with type 1 diabetes disordered eating (T1DE): a mixed methods evaluation

Por: Harkness · E. F. · Bashir · S. · Kletter · M. · Gillibrand · S. · Wilson · P. · Dumville · J. · Bower · P.
Objectives

People with type 1 diabetes may be at increased risk of disordered eating, which may increase risk of elevated poor outcomes and high-risk complications. Type 1 diabetes disordered eating (T1DE) services were set-up to integrate diabetes and mental healthcare to better support people with T1DE and improve longer-term outcomes. A rapid evaluation was conducted to explore the implementation of T1DE services. Specifically, we aimed to: describe service delivery models; investigate staff experiences of impact and delivery of implementation; explore patient experiences of T1DE services; and to report health outcomes and associated costs.

Design

Rapid evaluation using mixed methods (service mapping, staff and patient interviews, staff survey, analysis of clinical and economic data). Health outcome data was reported at baseline and 6 months.

Setting

This study explored the implementation of five new T1DE services and three existing services.

Participants

Staff working within T1DE services and patients who received care from T1DE services.

Results

Assessment of our mixed methods study identified four key findings: (1) T1DE delivery models: The T1DE services displayed modest variation in models of delivery, but similarities were more evident, with a focus on direct delivery to patients involving joint meetings between diabetes and mental health staff. Nevertheless, some services also took on a ‘consultation’ role, providing advice and support to wider staff outside the service also managing these patients. Delayed implementation of the services slowed the formation of fully integrated teams and the ability of services to operate at scale. (2) Staff experience: Workforce issues were a crucial aspect of T1DE pilots. Managing this patient population is associated with high levels of anxiety for staff. Nevertheless, once formed, staff reported a very positive experience of working in integrated teams. (3) Patient experience: Although only a small sample of patients were interviewed, they reported a profoundly different experience to their previous care, which was now perceived as supportive and relationship focused. Although such improvements were aligned with the integrated care model underlying T1DE, it was less clear how such changes in patient experience would feature in decisions about commissioning. (4) Health outcomes and associated costs: There were 139 patients accepted onto the care pathway. Improvements were seen for all health outcomes. Compared with baseline measures, there was a mean 0.97% reduction in HbA1c (glycated haemoglobin) from 11.2% to 10.2% at 6 months. Improvements were also seen in other outcomes, including the diabetes eating problem scale and the diabetes distress scale. However, the number of patients on the care pathway with follow-up at 6 months was relatively small (n=29–47) and definitive statements about clinical or cost-effectiveness were not possible.

Conclusions

Overall, T1DE services were well received by both staff and patients. Due to a number of logistical challenges, the implementation of services was slower than anticipated, resulting in a limited number of patients on the care pathway. Securing local funding for existing services, once national pilot funding ended, was identified as a significant challenge. In order to ensure services are sustainable and commissioned at a local level, consideration may need to be given to alternative service delivery models.

MULTIsite feasibility of MUSIc therapy to address Quality Of Life in Sickle cell disease (MULTI-MUSIQOLS): protocol for a mixed-methods randomised controlled trial at two US medical centres

Por: Rodgers-Melnick · S. N. · Gorthi · V. · Foss · A. · Erande · A. · DiFrancesco · K. · Owusu-Ansah · A. · Anim · S. · Bretz · S. · Ketter · P. · Fuqua · T. · Anderson · A. R. · Karasz · A. · Bailey · L. · Ezenwa · M. · Jenerette · C. · Dusek · J. A.
Introduction

Accessible, person-centred, non-pharmacologic modalities are needed to address chronic pain and health-related quality of life (HRQoL) among individuals with sickle cell disease (SCD). Building off prior single-site pilot studies of music therapy (MT) in SCD, the purpose of this study is to (1) examine the data collection processes and intervention implementation overall and across two sites and (2) evaluate the implementation of the MT and health education interventions using quantitative and qualitative data.

Methods and analysis

This three-arm, two-site, feasibility randomised controlled trial will include 90 individuals ≥14 years who have SCD, chronic pain and access to a mobile device who are not currently engaged in mind-body pain management interventions under the supervision of a healthcare professional. Participants will be randomised to six sessions over 8 weeks of either: (1) in-person MT, (2) hybrid (one in-person, five virtual) MT or (3) hybrid health education. Patient-reported outcome measures of HRQoL and self-efficacy will be assessed at baseline, post-intervention and 6 weeks post-intervention. 24 participants (eight per arm) and 20 stakeholders (eg, haematologists, music therapists, nurses) will be invited to complete semi-structured interviews to further examine intervention acceptability, perceived benefits and implementation. Sessions will be monitored for fidelity, and participants lacking access to home internet or videoconferencing technology will be provided tablets to engage in virtual sessions. Feasibility will be determined by rates of data completion, recruitment, retention, session attendance and home practice.

Ethics and dissemination

This study was approved by the University Hospitals Cleveland Medical Center Institutional Review Board (STUDY20231055). The dissemination plan includes presenting findings at national and international scientific conferences and publishing in peer-reviewed journals. All activities will be conducted in collaboration with SCD community stakeholders.

Trial registration number

NCT06853158.

Cognitive-behavioural therapy smartphone app for low mood and worry management in female armed forces veterans in Great Britain: protocol for a feasibility randomised controlled trial

Por: Janbakhsh · M. · Turnbull · E. · Baker · J. · Bacon · A. · Farrand · P.
Introduction

Emotional difficulties, such as low mood and worry, are more prevalent among female forces veterans compared to their male peers. However, female veterans are more reluctant to access mental health services available for armed force veterans. To enhance help seeking, the Iona female forces veterans (IonaFFV) research app has been developed and adapted for low mood and worry management among female veterans. This feasibility randomised controlled trial primarily seeks to explore the methodological uncertainties of conducting a definitive randomised controlled trial using IonaFFV. Secondary aims seek to explore acceptability and engagement with IonaFFV. Additionally, progression criteria will be assessed to determine feasibility of moving to a definitive trial.

Methods and analysis

Participants were recruited online and asked to complete two screening assessments to assess eligibility. Eligible participants were randomised using block randomisation to use either the IonaFFV or Iona sham app for 6 weeks. Recruitment and randomisation are complete, and data collection is currently ongoing. At the end of the 6-week intervention period, participants will complete the Patient Health Questionnaire-9, the Generalised Anxiety Disorder-7 and Work and Social Adjustment Scale outcome measures. At 4 weeks postintervention (10 weeks postrandomisation), participants will complete the same outcome measures in addition to the mHealth App Usability Questionnaire (MAUQ) to assess acceptability of both IonaFFV and Iona sham. At the end of the study, the participants who were in the Iona sham group will be given an option to use the IonaFFV app for 6 weeks. Proportions will be reported for feasibility and demographic data with descriptive analysis conducted for the outcome measures. Median values with IQRs will be conducted for each subscale of MAUQ.

Ethics and dissemination

This study received ethical approval from the University of Exeter Psychology Ethics Committee with consent obtained from all participants. Study findings will be published in peer-reviewed journals, presented at conferences, with a final report presented to the funders of the project.

Trial registration number

ISRCTN50744553.

Promoting active outdoor play and healthy dietary behaviours through the co-creation of supporting physical and social environments for and with primary school-aged children living in underserved neighbourhoods in Europe: the protocol of the B-Challenged

Por: Altenburg · T. M. · Pawlowski · C. S. · Ahrens · W. · Brand · T. · Buck · C. · Börnhorst · C. · Dzielska · A. · Klaufus · L. · De Miguel-Etayo · P. · Moreno · L. · Okulicz-Kozaryn · K. · Vrijkotte · T. G. M. · Wink · R. · Belmon · L. S. · Chinapaw · M. J. M.
Introduction

An alarmingly low number of children meet public health guidelines for physical activity and dietary behaviours and, therefore, are at increased risk of developing lifestyle-related diseases. This paper describes the protocol of the B-Challenged project, which aims to co-create systemic actions to promote active outdoor play and healthy dietary behaviours before, during or after their outdoor play together with children themselves.

Methods and analysis

In five European countries, child-centred Participatory Action Research (PAR)—combined with systems dynamics methods—was conducted with 15–20 child co-researchers (aged 9–12 years) and 15–20 adult actors (eg, youth workers, local policy makers). In the first phase, the main drivers of children’s active outdoor play and related dietary behaviours were mapped by (1) analysing existing cohort data, and (2) conducting child-centred PAR. In the second phase, systemic actions targeting the local physical and social environments will be co-created and implemented by child co-researchers and adult actors to promote children’s active outdoor play and related healthy dietary behaviours. A mixed-methods design will be used to evaluate (1) if actions positively contributed to systems change and 6- to 12-year-olds’ outdoor play and related dietary behaviours (140 children per country); (2) the process of conducting multi-actor, child-centred PAR and implementing the co-created actions and (3) if the child-centred PAR positively contributed to child co-researchers’ feelings of empowerment.

Ethics and dissemination

Ethics approval for the mapping phase was obtained and approval for implementation and evaluation will be obtained from the five local research institutions. Participating children, one of their parents/caregivers and adult actors had given informed consent before participating in the project. Throughout the project, child-friendly methods, materials and language will be applied, and ethical challenges and potential solutions will be discussed. Project results will be disseminated locally and internationally through various channels and activities among the scientific community, professionals—for example, in health and policy making, children and other citizens.

Trial registration number

NCT07136376.

Digital patient decision aids for endometriosis management: a scoping review protocol

Por: Pittet · O. · Delvallee · M. · Pluchino · N. · Selby · K. J. · Elwyn · G. · Durand · M.-A.
Introduction

Endometriosis is a chronic, oestrogen-dependent condition with a wide range of symptoms and comorbidities that significantly affect physical, emotional and psychological well-being, as well as quality of life. Women with endometriosis often face complex treatment decisions with no universally accepted gold-standard therapy. Shared decision-making, supported by patient decision aids (PtDAs), can enhance patient knowledge and promote informed preferences and decisions. Digital PtDAs, in particular, offer potential for personalised, interactive and accessible decision support. Their characteristics, development process and evaluation in endometriosis care remain underexplored. The objective of this scoping review is to map the existing literature on digital PtDAs developed for women of reproductive age (18–49) with endometriosis, across a range of healthcare and digital health contexts.

Methods and analysis

This scoping review will follow the Joanna Briggs Institute (JBI) methodology for scoping reviews. A comprehensive three-step search, developed with an information specialist, will be conducted across MEDLINE (PubMed), CINAHL, Embase, Web of Science, Cochrane databases and grey literature sources. Citations will be imported into Rayyan for screening. Two independent reviewers will conduct study selection, data extraction and analysis. Data will be summarised using tables and descriptive content analysis to identify key features, development processes and evaluation methods of digital PtDAs. The review will be reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.

Ethics and dissemination

This review started off in July 2025, and the anticipated end date is November 2025. We plan to disseminate this research through publications, presentations at relevant national and international conferences and meetings with relevant stakeholders. This scoping review protocol has been registered at Open Science Framework (osf.io/fp86m). As this scoping review will use data from published and publicly available sources, research ethics approval is not required.

Tofacitinib in rheumatoid arthritis: a German real-world study with focus on treatment changes, effectiveness and patient-reported outcomes (ESCALATE-RA)

Por: Krueger · K. · Behrens · F. · Brandt-Juergens · J. · Detert · J. · Feuchtenberger · M. · Prothmann · U. · Behmer · O. · Hsieh · M.-J. M. · Jobst · J. · Klaus · P. · Meng · T.
Objective

To identify predictors of treatment changes and to evaluate the effectiveness and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) initiating tofacitinib in a real-world setting.

Design

The non-interventional study ESCALATE-RA included 1518 patients with RA from Germany. RA treatment, including all changes in therapy, was documented for 24 months starting from the initial intake of tofacitinib.

Participants

All patients started with tofacitinib therapy, either as monotherapy or in combination with methotrexate (MTX).

Primary and secondary outcome measures

The impact of several factors of interest on the number and timing of treatment changes was assessed as primary outcome using Cox proportional hazards models. Further outcomes were tofacitinib drug survival and the use of follow-up disease-modifying antirheumatic drugs after first treatment change. We also assessed the effectiveness, concomitant glucocorticoid (GC) use, PROs (such as functional ability, patient satisfaction, pain and quality of life) and safety. Analyses were based on observed data.

Results

‘Lack of efficacy’ (HR 3.30) and ‘intolerance’ (HR 4.43) leading to termination of tofacitinib were key factors favouring therapy changes. Higher patient satisfaction was significantly associated with a reduced likelihood of treatment changes (HR 0.82). Increasing GC doses were associated with a higher probability of step-up/switch changes (HR 1.21). The estimated tofacitinib drug survival was 48% at the end of study. Proportions of patients achieving low disease activity (both Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) 62%) and remission (SDAI 25%, CDAI 28%) increased from baseline under tofacitinib and were comparable between monotherapy and combination therapy with MTX. Mean concomitant GC dose decreased (2 mg/day). PROs indicated reduced pain and fatigue, while functional ability and quality of life improved. 63.9% of the patients experienced a treatment-emergent adverse event (AE), 8.8% a treatment-emergent AE of special interest and deaths occurred in 0.5%.

Conclusion

Key factors for therapy changes in patients with RA treated with tofacitinib were lack of efficacy and intolerance. Higher patient satisfaction was associated with a reduced probability of treatment changes, while increased GC doses led to a higher likelihood of step-ups/switches. Patients demonstrated a marked reduction in disease activity for up to 24 months, along with improvements in functional ability, pain and quality of life. Observed AEs were consistent with the known safety profile of tofacitinib.

Trial registration number

NCT03387423.

Longitudinal study of childbirth readiness and its related factors and consequences among low-risk pregnant women attending health centres in Tabriz, Iran

Objective

Childbirth readiness can reflect women’s childbirth readiness in terms of knowledge, psychological aspects and planning. The purpose of this study was to evaluate childbirth readiness, its related factors and consequences in Iranian pregnant women.

Design

This longitudinal study was the first stage (quantitative stage) of a sequential explanatory mixed-method study. It followed women during late pregnancy (from 37 weeks of gestation) and the postpartum period (4–6 weeks after childbirth) from March to September 2023.

Setting

Health centres of Tabriz, Iran.

Participants

This study involved 360 pregnant women with a gestational age of 37 weeks and above, selected via cluster sampling. Participants were excluded for high-risk pregnancies, unfavourable incidents in the last 3 months, mental-psychological diseases or a prior caesarean section.

Outcome measures

Childbirth readiness and its related factors were assessed using several instruments completed from the 37th week of pregnancy onward, including the Childbirth Readiness Scale, a sociodemographic questionnaire, the Pregnancy Experience Scale and the Wijma Delivery Expectancy/Experience Questionnaire Version A. The consequences of childbirth readiness were then evaluated 4–6 weeks post partum using the Childbirth Experience Questionnaire, the Edinburgh Postnatal Depression Scale and the Postpartum-Specific Anxiety Scale.

Results

The mean (SD) childbirth readiness score was 67.83 (9.41) out of 90. In the adjusted general linear model (GLM), several factors were significantly associated with lower readiness. These included a higher fear of childbirth score (β –0.12, 95% CI –0.16 to –0.08, p

Conclusions

Key factors associated with readiness included fear of childbirth, obstetric history (gravidity, parity, history of abortion and participation in childbirth readiness classes), maternal education, home ownership, husband’s occupation—though several associations showed small effect sizes. After adjustment, readiness did not independently predict childbirth experience or postpartum mental health. The low participation rate in readiness courses highlights a major service gap. Integrating readiness assessment into prenatal care and expanding access to targeted education are recommended to improve outcomes such as birth satisfaction and caesarean rates.

Prevalence and risk factors of chronic kidney disease among Iranian adults with and without diabetes: a cross-sectional study using STEPS 2021 national survey

Por: Ataei · S. M.-N. · Almasi · G. · Kazemi · A. · Ahmadi · N. · Golestani · A. · Rashidi · M.-M. · Rezaei · N. · Azadnajafabad · S. · Rezaei · N. · Dilmaghani-Marand · A. · Ghasemi · E. · Farzi · Y. · Yoosefi · M. · Rezaee · K. · Foroutan Mehr · E. · Nasserinejad · M. · Haghshenas · R. · Al
Objectives

Chronic kidney disease (CKD) is a global health concern and a major long-term complication of diabetes, yet its burden remains understudied in regions with limited epidemiological data. This study aimed to evaluate the prevalence of CKD and its associated risk factors in the Iranian adult population, stratified by diabetes status.

Design

Population-based cross-sectional study.

Setting

Nationally representative survey across Iran (STEPS 2021).

Participants

17 607 adults aged ≥25 years with complete kidney function and albuminuria data, selected through systematic sampling with weighting to ensure national representativeness.

Primary and secondary outcome measures

CKD was defined as an estimated glomerular filtration rate (eGFR)

Results

The national prevalence of CKD was 11.9% (95% CI 11.2% to 12.6%), with 9.1% (8.5% to 9.9%) among individuals without diabetes and 28.6% (26.2% to 31.1%) among those with diabetes. According to KDIGO classification, 88.1% (87.4% to 88.8%) were at low risk, 9.0% (8.4% to 9.6%) at moderate risk, 2.0% (1.6% to 2.4%) at high risk and 0.9% (0.7% to 1.1%) at very high risk. Albuminuria was more prevalent than low eGFR in both groups with (22.5% (20.4% to 24.8%) vs 10.3% (8.7% to 12.1%)) and without (5.7% (5.2% to 6.3%) vs 4.3% (3.8% to 4.8%)) diabetes. Diabetes was more strongly linked to albuminuria than low eGFR and was progressively associated with higher risk categories (adjusted ORs (aORs) 2.41 (2.03–2.86) for moderate, 2.63 (1.74–3.97) for high, 3.93 (2.56–6.07) for very high vs low-risk). CKD prevalence was highest in northwest Iran, increased significantly with age, with a stronger association observed for low eGFR than albuminuria, and was associated with hypertension (aOR 2.41 (2.07–2.82)), dyslipidaemia (1.60 (1.31–1.94)), obesity (1.94 (1.59–2.36)), ischaemic heart disease (1.53 (1.25–1.87)) and physical inactivity (1.40 (1.20–1.62)). Higher socioeconomic status and education were associated with lower odds of CKD.

Conclusions

CKD is a major burden, especially in individuals with diabetes, with regional and socioeconomic disparities. Addressing risk factors, integrating CKD into non-communicable disease surveillance and prioritising it in global health agendas, including the Sustainable Development Goals, are essential.

Prevalence of limited health literacy in blue-collar workers: a systematic review protocol

Por: Pires Rodrigues · G. A. · Duong · P. · Luthi · F. · Leger · B. · Melly · P. · Durand · M.-A.
Introduction

Health literacy (HL) is defined as the ability to access, understand, evaluate and apply health-related information, which can influence individuals’ health outcomes. Blue-collar workers, who often have lower educational attainment and experience language barriers, are at increased risk of limited HL. This systematic review aims to assess the prevalence of limited HL among blue-collar workers to inform the development of appropriate interventions for its improvement.

Methods and analysis

The systematic review will assess the prevalence of limited HL among blue-collar workers. We will include all quantitative study designs using any instrument for measuring general HL. We will exclude studies that focus on specific types of HL and specific health conditions. We have performed a literature search from inception up to 30 April 2025, in the Medline, Embase, CINAHL, Web of Science and Cochrane Central Register of Controlled Trials (CENTRAL) databases. We will also search eligible articles from Google Scholar and Open Grey as sources of unpublished studies/gray literature. Two independent reviewers will conduct the primary screening of articles, data extraction and quality assessment (using the Cochrane risk-of-bias tool for randomised trials and risk of bias in non-randomised studies of exposure), with a third individual available to resolve conflicts. We will assess heterogeneity using the ² test and I² test. If there is sufficient homogeneity, we will pool studies in a meta-analysis or summarise the findings narratively if heterogeneity is too high. We will use a random effects model for our analysis, and we will use funnel plots to evaluate potential publication bias. The Grading of Recommendations Assessment, Development and Evaluation approach will be used to assess the certainty of findings.

Ethics and dissemination

Ethical approval will not be required for this review as there is no primary data collection involving humans. The results will be published in a peer-reviewed journal and presented at relevant conferences.

PROSPERO registration number

CRD42024597732.

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