To develop and user-test a patient decision aid for people diagnosed with degenerative cervical myelopathy and who are considering surgery.

Mixed-methods study describing the development of a patient decision aid.

A draft decision aid was developed by a multidisciplinary steering group (including study authors with degenerative cervical myelopathy, health professionals and researchers) informed by the best available evidence, authorship consensus and existing patient decision aids.

Patient-participants and health professional-participants who manage people with degenerative cervical myelopathy were recruited through social media and the steering group’s research and practice network. Quantitative questionnaires were used to gather baseline data, descriptive feedback, refine the decision aid and assess its acceptability. Qualitative semi-structured interviews were conducted online to gather feedback on the decision aid and were analysed using reflexive thematic analysis.

We conducted 32 interviews: 19 patient-participants and 13 health professional-participants who manage people with degenerative cervical myelopathy (neurosurgeons, neurologists, physiotherapists, orthopaedic surgeons, general practitioners, rehabilitation and pain specialists and consultant occupational physicians and chiropractors). Participants were from 10 countries (Australia, Canada, Cyprus, Germany, Ireland, New Zealand, Sweden, Switzerland, United Kingdom and USA). Most participants rated the decision aid’s acceptability as good-to-excellent and agreed with most aspects of the decision aid (eg, defining degenerative cervical myelopathy, management recommendations, potential benefits and harms, questions to consider asking a health professional).

Our patient decision aid was rated as an acceptable tool by both health professional-participants who treat degenerative cervical myelopathy and patient-participants with lived experience of degenerative cervical myelopathy. This decision aid can be used by clinicians and people with degenerative cervical myelopathy to help with shared decision making following a diagnosis of degenerative cervical myelopathy. A study testing the potential benefits of this decision aid in a clinical setting is recommended.

Video-assisted thoracoscopic surgery (VATS) lobectomy is a commonly employed surgical technique for the management of operable early stage non-small cell lung cancer (NSCLC). This procedure, however, is dependent on the patient’s ability to tolerate surgery. In light of this, stereotactic ablative radiotherapy (SABR) has emerged as a viable alternative treatment strategy for patients who are inoperable or who refuse surgery. Considering the lack of randomised controlled trials and the increased risk of bias in observational cohort studies, this study protocol proposes an emulated target trial design to investigate the causal effect of SABR, in comparison to VATS, on overall survival in operable early stage NSCLC patients.

Data on NSCLC patients will be collected from routinely collected university hospital records linked with German cancer registry data. This study protocol was developed using the target trial methodology outlined by Hernan et al. The protocol establishes specific parameters for key trial components in order to mitigate bias in the analysis of observational data and to facilitate the calculation of causal estimands. The target trial design that would be emulated is a multicentre open-label two-parallel arm superiority randomised trial. Mediators and confounding variables were determined through the use of a directed acyclic graph. The statistical analysis aims to measure the per-protocol and intention to treat effect of SABR versus VATS within 3 months of diagnosis, on survival, through the difference in restricted mean survival times, using weighted non-parametric Kaplan-Meier curves.

The Ethics Committee of the Medical Faculty of Martin Luther University Halle-Wittenberg with an approved addendum with Dnr 2023–112 has approved this study. The study uses anonymised routinely collected hospital and cancer registry data in accordance with applicable data protection regulations. Results will be disseminated through peer-reviewed publications and presentations at scientific conferences.

Patient decision aids (PtDAs) are effective interventions to support patient involvement in health decisions and have the potential to impact favourably on health inequities by reducing gender bias in clinical practice. The aim was to explore sex and gender reporting and differences in randomised controlled trials (RCTs) evaluating PtDAs for adults making treatment or screening decisions.

Secondary analysis of the Cochrane review of PtDAs of RCTs that reported sex and/or gender. The original review searched MEDLINE, Embase, PsychINFO and EBSCO from journal inception to March 2022. Two team members independently screened citations, extracted data and assessed risk of bias. For this secondary analysis, we only included primary outcomes from the original review. We assessed appropriate use of terminology for sex (biological attribute) and gender (social construct). When terms were used interchangeably, it was considered inaccurate. Findings were synthesised descriptively, and we used meta-analysis when two or more RCTs were conducted with females/women or males/men using similar outcome measures.

Informed values-choice congruence and the quality of the decision-making process (eg, knowledge, accurate risk perceptions, feeling informed, clear values, participation in decision making, undecided) and adverse events (eg, decision regret, emotional distress) by sex and gender.

Of 209 RCTs in the original review, 206 reported sex and/or gender, with 35 (17%) using accurate terminology. Of 206 RCTs, 70 were with females/women only, 27 males/men only, 12 analysed by sex/gender and 97 RCTs did not disaggregate findings by sex or gender. Meta-analysis comparing RCTs for females/women to usual care and RCTs for males/men only compared with usual care showed similar mean differences in knowledge scores (10.84 vs 9.38 out of 100; p=0.44). Males/men had significantly higher self-reported participation in decision making compared with females/women (RR 3.16 vs 0.95; p

In PtDA RCTs, sex and gender terms are used interchangeably and 6% analysed outcomes by sex or gender. Meta-analysis of males/men only given PtDAs showed higher self-reported decision making participation in clinical practice compared to usual care versus females/women only compared with usual care. Researchers must improve reporting sex and gender in PtDA RCTs to assess how it influences health inequities.

The interfaces between the fields of communication, education and health have been indicated by international institutions such as the WHO and the European Centre for Disease Prevention and Control. However, hegemonic scientific practices supersede dialogue between the three fields, isolating their practices. This fragmenting tendency is observed in scientific literature, which has created gaps in the dialogue and articulation between communication, education and health. Although health promotion requires both communicative and educational practices, the epistemological, historical, political, cultural and socioeconomic aspects have also engendered tensions between the fields. Communication is often seen as a mere instrument for other practices, rather than a phenomenon that (re)produces meanings and power dynamics. In opposing the reductionist and instrumentalising perspectives of knowledge fields, the primary objective of the scoping review is to map the scientific evidence on the interfaces between communication and education in health to indicate a conceptual framework that articulates communication and education practices within the context of health.

A transdisciplinary team developed this protocol based on the 2024 Joanna Briggs Institute Manual for Evidence Synthesis. The procedures required to conduct the review were guided by the frameworks proposed by Arksey and O'Malley, Levac et al and Peters et al. The study eligibility criteria were established based on the Problem, Concept and Context outlined in the research questions. Primary and secondary studies will be retrieved from nine sources, covering both conventional and grey literature. These sources include Embase, ERIC, LILACS, PubMed/MEDLINE, ScienceDirect, Scopus, Web of Science, the Brazilian Digital Library of Theses and Dissertations, and the Networked Digital Library of Theses and Dissertations. A categorised form will be used for data collection and subsequent analysis. The reporting of the review findings will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.

The nature of the research and the use of secondary data sources do not require informed consent forms or approval from ethics committees in Brazil. The scientific findings from the review will be disseminated through peer-reviewed journals, academic conferences and other scientific communication channels.

The protocol was registered on the Open Science Framework (OSF) and is available at https://doi.org/10.17605/OSF.IO/Z3CX7.

This study aimed to examine the impact of type 1 diabetes (T1D) on the sexual functioning of young women and men, concerning demographic and social factors.

Cross-sectional quantitative survey study.

Online survey distributed via internet forums for people with T1D in Poland (March 2021).

344 individuals completed the survey; 329 sexually active participants were included in the analyses (15 excluded due to sexual inactivity), of whom 177 had T1D (aged 20–60 years; mean age 31.31±7.40) and 152 were healthy controls (mean age 35.43±7.46).

Sexual functioning was assessed using the CSFQ-14 (Changes in Sexual Functioning Questionnaire), available in female and male versions. Additional author-designed questions were included to enhance understanding of the problem.

34.4% of men and 28.4% of women with T1D reported sexual dysfunctions. Women with T1D showed significantly lower overall sexual functioning compared with controls (mean difference: –4.09 points, 95% CI (–6.29 to –1.90), Cohen’s d=–0.54). Men with T1D demonstrated substantially greater impairment (mean difference: –11.15 points, 95% CI (–14.89 to –7.41), Cohen’s d=–1.47). Among men with T1D, significant differences were found in the total CSFQ score (²=8.98, p=0.003, V=0.26) and the orgasm subscale (²=11.91, p

Sexual dysfunction in young adults with T1D is more common than in healthy individuals. Men with T1D are more likely to report difficulty achieving orgasm and decreased desire for their partner, whereas women with T1D are more likely to report difficulty experiencing pleasure and lower levels of arousal.

Malnutrition is a highly prevalent chronic condition that contributes to higher morbidity and mortality in patients with multiple comorbidities. While positive effects of nutritional therapy in the in-hospital setting have recently been demonstrated, the benefits of long-term nutritional therapy after hospital discharge remain uncertain. Herein, we outline the design and rationale of the EFFORTII trial, the largest nutritional trial to date to assess the effects of continued nutritional support after hospital discharge in medical patients, with particular attention to key design decisions regarding nutritional strategy, patient selection criteria and study endpoints.

The Effect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery (EFFORTII) is an investigator-initiated, non-commercial randomised controlled trial designed to evaluate whether ongoing, individualised nutritional therapy after hospital discharge—targeted to meet specific energy and protein requirements—offers a cost-effective approach to lowering mortality, minimising complications and maintaining functional status compared with standard care. Eligible participants are adult, chronically ill medical inpatients at risk of malnutrition. Patients in the intervention group receive individualised nutritional therapy delivered by an experienced dietitian through a combination of telemedicine and in-person consultations. The intervention aims to meet personalised nutritional targets, supported by a trained dietitian. Control group patients receive nutritional counselling at discharge, but no structured nutritional management during follow-up. We designed the trial as an event-driven trial with a target of 247 mortality events (primary endpoint), which will be assessed over approximately 5 years until event-driven endpoint is met. The minimum total sample size is at least 802 participants, based on the assumed treatment HR of 0.70. The main trial is enrolling patients across multiple sites in Switzerland. During the trial, additional sites in Spain joined the study, and their data will be analysed using a patient-level pooled approach.

This study involves human participants and was first granted ethical approval by the Ethics Committee Northwest- and Central Switzerland and then by all participating local ethics committees. Written informed consent will be obtained from all participants. Findings will be disseminated in peer-reviewed journals and academic conferences.

NCT04926597.

The aim of this study is to explore in depth adolescents’ insights regarding experiences of spectacle lens wear and its correlation with self-perception, quality of life, social interactions, adherence and barriers.

Qualitative design through individual interviews and thematic analysis.

Middle school students in five regions of Jakarta Province.

31 middle school adolescents who participated and received free spectacle wear by the Indonesian Ophthalmologist Association.

A set of semistructured questionnaires exploring adolescents’ perception regarding spectacle lens wear, adapted from the PedEyeQ. Interviews were conducted on site or through Zoom and were then transcribed.

Thematic analysis identified three themes, as follows: (1) experience with eyeglasses, (2) motivation and encouragement and (3) barriers to usage. This study found that more than half of adolescents received their first spectacles during the outreach programme, with most reporting improved vision and academic performance after spectacle wear. However, adherence varied, as some participants—particularly those with moderate to high myopia and astigmatism—did not use their new glasses due to discomfort, poor fit or dissatisfaction with visual clarity. While initial adaptation often involved dizziness or soreness, most adjusted within a week. The majority recognised the importance of spectacle wear, describing clearer vision, reduced eye strain and improved confidence, though a minority viewed it as unnecessary. Parents played a central role in influencing health-seeking behaviour, and limited prior access to eye examinations and geographic challenges restricted care for several adolescents. Financial concerns were reported by a small proportion, while psychological barriers such as fear of teasing or negative self-perception were the major barrier. Overall, adolescents highlighted both the benefits and challenges of spectacle wear, with motivation shaped by personal experience, parental influence and accessibility of eye care services.

Findings showed insight that adolescent understanding regarding eye health is imperative to support adherence. However, psychological barriers act as a major factor that impedes lens wear. Involving parents and teachers in understanding urgency and severity of eye health in adolescents, specifically refractive error and its long-term negative impact, as well as the prominent psychological barriers, may improve adolescent perception and adherence.

Severe mental illness such as psychosis is among the most disabling illnesses worldwide, disproportionately affecting minoritised ethnic groups and those in socioeconomic disadvantage. In the UK, people from Black ethnic backgrounds are more likely to experience a first episode of psychosis and to be detained under the Mental Health Act than White British people. There is a clear need for mental health services to improve cultural awareness and understanding of the broader social needs of minoritised groups, as well as the need to improve mental health literacy (MHL) within Black communities to empower individuals to seek timely mental health support. This protocol describes our programme of work which aims to assess the feasibility, acceptability and cost-effectiveness of Co-STARS, which is a co-produced, culturally appropriate tiered training package.

We co-produced a culturally appropriate, place-based, tiered MHL training package (Co-STARS) to deliver within underserved Black communities and via an e-learning package implemented among staff within mental health trusts. The training will be evaluated in stages. First, a pilot cluster randomised controlled trial will assess the feasibility and acceptability (defined as participants’ perceptions of the training’s relevance, usefulness and delivery) of a lived experience-led MHL training package delivered by Black young people with experience of mental ill health, to underserved communities in Birmingham, UK. Acceptability will be quantified through participation and completion rates and explored qualitatively via focus groups and interviews. Second, a stepped-wedge cluster randomised trial will evaluate the feasibility of an e-learning training programme for mental health professionals. We will embed a process evaluation to explore change mechanisms and identify barriers and enablers for future implementation. Third, we will use realist-informed participatory systems mapping and novel epidemiological analyses to explore downstream effects (ie, improved care access for Black ethno-racial groups within the intervention areas). Last, a cost-effectiveness framework will be developed to assess whether the intervention is good value for money in future efficacy trials. In the cluster trial, eight clusters will be randomised to the intervention arm (face-to-face training in the community) and control arm (display of MHL materials) with pre- and post-assessments in 120 participants from 8 clusters, 3 weeks apart. In the stepped wedge trial, six clusters (clinical teams within NHS mental health trusts) including 120 NHS staff in total, will move from control phase to intervention phase in a stepped wedge manner, with pre-assessments and post-assessments.

This proposal was reviewed by the Research Governance of the University of Birmingham and UK Research and Innovation (UKRI) grant reviewers. Ethics approval was granted by East of Scotland Research Ethics Service. The findings will be communicated in research conferences, stakeholder meetings, via social media, through publication in peer-reviewed journals and as a policy document.

ISRCTN10517405.

To estimate the prevalence of potential overtreatment of type 2 diabetes mellitus (T2DM) among older adults and to develop and compare predictive models to identify patient and physician characteristics associated with overtreatment.

Population-based retrospective cohort study with predictive modelling.

A province-wide, publicly funded healthcare system in British Columbia, Canada, using linked administrative health claims data from 2016 to 2023.

Residents of long-term care facilities over age 65, and community-dwelling individuals over age 75, with a diagnosis of T2DM and a glycated haemoglobin (A1C) laboratory value ≤7.0%. Participants were required to have ≥365 days of continuous provincial health insurance coverage prior to their index A1C test. Patients receiving palliative care and those with missing physician information were excluded.

Potential overtreatment of T2DM, defined a priori as overlapping prescriptions for ≥2 glucose-lowering medications or ≥1 insulin or sulfonylurea dispensing within 90 days after the index A1C test.

Model performance outcomes included discrimination (area under the curve (AUC), sensitivity, specificity, positive predictive value and negative predictive value). Performance metrics were calculated with 95% CIs using a 25% temporally distinct test dataset (2021–2023). No changes were made to outcome definitions after protocol development.

Among 133 773 patients with an A1C≤7.0%, 38 074 (28.5%) were classified as overtreated. These patients had a mean age of 79.6 years, were 47% female, and had a median A1C of 6.4%. The gradient boost model was the best performing model overall, using a combination of expert-selected variables and data-driven variables, achieving an AUC of 0.87, sensitivity of 0.81 and negative predictive value of 0.89. The top predictors of overtreatment included use of blood glucose test strips, A1C test volume, polypharmacy, specialist involvement and measures of diabetes severity.

Overtreatment of T2DM was prevalent among older adults in our cohort. Machine learning algorithms that integrate clinical expertise with data-driven variable selection performed the best in predicting T2DM overtreatment. We identified several patient and physician characteristics as key contributors that may inform future clinical practice and quality improvement initiatives, although external validation is required before clinical implementation.

To identify and prioritise research uncertainties regarding the assessment, management and rehabilitation of patients with problematic hip replacements through a national Priority Setting Partnership (PSP).

A national PSP using the James Lind Alliance (JLA) methodology.

UK.

Patients, carers and healthcare professionals (HCPs) involved in the care of patients with problematic hip replacements.

A steering group was established. The James Lind Alliance methodology was followed throughout. A nationwide survey was conducted to collect unanswered questions. These were refined, prioritised through an interim survey and ranked at a final consensus workshop.

The initial survey yielded 201 questions, refined to 32. The interim survey had 191 respondents, leading to 19 questions at the final workshop. The top 10 research priorities were agreed on.

This PSP identified key research priorities for problematic hip replacements, focusing on diagnosis, pain management, perioperative optimisation and infection. These priorities can inform researchers and funders to improve outcomes for affected patients.

Newborn bloodspot screening (NBS) is freely and universally available to babies born in Australia, with nearly 300 000 newborns screened each year. The NBS programme screens for approximately 30 conditions; however, there are hundreds of childhood conditions that could be treated if identified earlier and asymptomatically. Contemporary screening platforms have relied on mass spectrometry-based technologies, limiting surveillance to conditions with validated biomarkers detectable within the neonatal period. Advancements in metabolic techniques and genomics have expanded the range of conditions that could be detected. The NewbornsInSA research study will develop, validate and evaluate a novel multi-omic model of newborn screening, integrating metabolomic and genomic newborn screening as complementary methodologies.

Parents can opt in to additional NBS through NewbornsInSA during pregnancy or shortly after birth. One thousand prospectively recruited families will be offered genomic NBS by whole-genome sequencing, including analysis of a virtual gene panel of over 600 genes, and concurrent metabolomic screening. Clinically actionable pathogenic or likely pathogenic genetic variants will be reported to parents and whole genome sequencing data will be available on request for diagnostic reanalysis, if required later in life.

Acceptability of the NewbornsInSA programme will be evaluated through stakeholder engagement activities with healthcare professionals, members of the public and patient advocacy groups. Family experiences will be assessed using online surveys. The diagnostic yield, accuracy and the costs and consequences of the multi-omic NBS model will be assessed by comparison to standard-of-care NBS.

NewbornsInSA will investigate the acceptability, feasibility and cost-effectiveness of a multi-omic newborn screening model in a prospectively recruited South Australian population. We hypothesise that this approach will increase the number of conditions identified, reduce the time to diagnosis and facilitate earlier care with better outcomes for newborns with genetic conditions.

This research study has been ethically approved by the Women’s and Children’s Health Network Human Research Ethics Committee (2022/HRE00258 and 2023/HRE00236). Findings will be disseminated through peer-reviewed publication and conferences.

The aim is to explore co-design facilitators’ perspectives and experiences of using co-design to improve intrapartum care in four sub-Saharan African settings. The inquiry focuses particularly on how they fostered engagement, built trust and mitigated unintended consequences during the co-design process.

Qualitative interview study with reflexive thematic analysis.

Sixteen public and private not-for-profit hospital-based maternity units in Benin, Malawi, Tanzania and Uganda (four per country).

A total population sample of 10 co-design facilitators involved in a hospital-based co-design project implemented in maternity units in Benin, Malawi, Tanzania and Uganda were interviewed. Semistructured interviews were conducted between December 2022 and January 2023.

Co-design facilitators viewed co-design as a collaborative process to develop contextually relevant solutions. Our findings elucidate their role in facilitating consensus-building and fostering stakeholder ownership amidst significant power divides. They described approaches co-design facilitators take to maintain ongoing stakeholder engagement and manage misaligned expectations in a trusting and collaborative environment, while being mindful of existing tensions and power imbalances. They also highlighted key challenges faced, including navigating norms, power imbalances and unintended consequences.

This study underscores the importance of power-sharing, fostering ownership and engaging end users equitably and continuously in co-design efforts, while also being aware of how to address its potential unintended consequences. Further research is needed to understand co-design facilitators’ impact on co-design and how to address unintended consequences for stakeholders during and after co-design activities in intrapartum interventions in low-resource settings.

This study aimed to quantify how patient risk factors relate to COVID-19 severity across categories 1–5 in a prospective, hospital-based cohort. We hypothesised that greater severity would be associated with higher odds of intensive care unit (ICU) admission and in-hospital mortality. Secondary aims were to assess associations with age, viral variants, symptom clusters, lymphocyte count, fasting blood glucose and cytokine profiles.

Prospective cohort study.

A secondary-care/tertiary-care hospital and linked community settings in Cheras, Kuala Lumpur, Malaysia.

This study was nested within the COVGEN project, a prospective COVID-19 cohort conducted at Hospital Canselor Tuanku Muhriz UKM (HCTM), Cheras Health Clinic and the Bandar Tun Razak COVID-19 Assessment Centre in Cheras, Kuala Lumpur, Malaysia, from 1 August 2021 to 31 October 2022. 2532 participants were enrolled at baseline. Eligible participants were Malaysian citizens aged 12–18 years (paediatric/adolescent) or ≥18 years who had reverse transcription-polymerase chain reaction–confirmed COVID-19 at recruitment and resided in Kuala Lumpur or Selangor. Patients who had a clinically unstable condition and those who declined participation (personally or via a next-of-kin or legal representative) were excluded. This analysis included 559 patients hospitalised at HCTM; after excluding five with incomplete questionnaires, 554 remained for analysis (413 admitted to general wards and 141 to ICUs). Categories 3–5 comprised hospitalised patients, whereas categories 1–2 included hospitalised individuals and a subset recruited from community settings.

Primary outcomes included disease severity (categories 4–5 vs 1–3), ICU admission and in-hospital mortality. Secondary outcomes included associations with age strata, viral variant (delta vs omicron), symptom clusters, lymphocyte count, fasting blood glucose and cytokines: interferon gamma-inducible protein 10, interferon gamma, interleukins 8, 10, 2, 6 and 7 and tumour necrosis factor alpha.

141 of 554 (25.5%) patients required ICU care. Compared with milder categories, category 5 was associated with markedly higher odds of ICU admission (OR 204.50; 95% CI 37.54 to 1114.18; p55 versus

An increasing clinical severity category was strongly associated with ICU admission and mortality. Age, delta infection, specific symptom clusters, lymphopenia, hyperglycaemia and pro-inflammatory cytokines identified higher-risk patients, supporting risk-stratified management and prioritisation for enhanced monitoring.