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Sources and consequences of self-doubt in patients with Ehlers-Danlos syndrome: a qualitative study in Europe and North America

Por: Halverson · C. M. E. · Vershaw · S. L. · Francomano · C. A. · Doyle · T.
Objectives

To examine how clinicians’ scepticism regarding patients’ self-reports of subjective symptoms can be internalised, leading to psychosocial and medical harms.

Design

In-depth, semi-structured qualitative interviews with the resulting data analysed using reflexive thematic analysis.

Participants

43 individuals with Ehlers-Danlos syndrome (EDS) from Europe and North America completed a pre-survey, and 39 of those participants completed interviews for this study. Purposive sampling was used to obtain approximately equal numbers of participants with hypermobile EDS and the molecularly defined types of EDS.

Results

Patients with both hypermobile and molecularly defined types of EDS reported high levels of self-doubt, with 73% of survey respondents questioning the extent—and even reality—of their private experiences of pain. Participants attributed much of their self-doubt to repeated dismissal and minimisation of their symptoms in healthcare settings, especially during childhood. Ultimately, self-doubt transformed not merely how they communicated their symptoms but also how they recognised, evaluated and even experienced them at a phenomenological level. While some participants developed coping strategies, others withdrew from the conventional medical system altogether.

Conclusion

These findings have important implications for clinicians, who may inadvertently reinforce self-doubt through discussion of diagnostic uncertainty. Doubt need not be delegitamising. Recognising and mitigating these potential harms requires epistemic humility and attention to the psychosocial dynamics of patient-provider interaction.

Exploring the links between NITAGs and academic institutions: a landscape analysis protocol

Por: Oduwole · E. O. · Hussey · G. D. · Hawkridge · A. · Noll · S. · Burton · A. · Sheridan · S. L. · Kagina · B.
Introduction

National Immunization Technical Advisory Groups (NITAGs) are multidisciplinary groups of national experts who provide independent advice to policy makers on issues related to immunisation and vaccines, based on evidence and the national context. On the other hand, academic institutions can be described as organisations dedicated to education and research. These include schools, colleges, universities and research centres that offer formal education, conduct scholarly research and contribute to knowledge in various fields. NITAGs can enhance their capacity by linking with academic institutions and leveraging scientific expertise in research, data analysis, modelling, resource procurement and management, and policy formulation. The proposed landscape analysis will explore the links between NITAGs and academic institutions, especially in the sub-Saharan African context, and, where such exist, document their characteristics and identify benefits, challenges and best practices for fostering such linkages.

Methods and analysis

This landscape analysis will use an adaptation of the WHO’s quick guide manual on ‘Performing a landscape analysis: Understanding health product research and development’. The planned landscape analysis will be conducted in two parts. The first part will entail a review of published literature to identify relevant documents on linkages between NITAGs and academic institutions. The second part will entail conducting key informant interviews with NITAG members, partners and other identified key stakeholders in two study countries: Ethiopia and Zambia. The transcribed scripts will be thematically analysed. The findings from both parts will be synthesised and presented as a descriptive landscape analysis report.

Ethics and dissemination

The protocol of the parent study has been reviewed and approved by the Human Research Ethics Committee of the University of Cape Town (Reference 417/2025). It has also been approved by the Biomedical Research Ethics Committee of the University of Zambia (REF. NO. 6760-2025) and the Ethiopian Public Health Association (EPHA/06/392/25). The landscape analysis report will be submitted to the commissioning funder (Gavi, the Vaccine Alliance) and will also be published in a peer-reviewed journal.

Registration details

https://osf.io/vprka

NeuroMusic: protocol for a randomised-controlled trial of keyboard and singing music training programmes for older adults with mild cognitive impairment

Por: Menczel Schrire · Z. · Mitchell · H. F. · Low · L.-F. · Espinosa · N. · Eames · P. · Toltz · J. · Walsh · P. · Mowszowski · L. · Espinoza · D. · Lin · C. S.-Y. · Peres Da Costa · N. · Naismith · S. L.
Introduction

Music-based training programmes, such as learning how to play an instrument or sing in a choir, have been suggested as potential interventions for promoting healthy brain ageing in older adults at risk of cognitive decline because of their ability to enhance cognitive functions and potentially promote neuroplasticity. However, there is limited empirical evidence in older adults at risk of dementia, especially that evaluates both piano and singing interventions and their effects on cognition and neuroplasticity. In this protocol, we outline a study to assess the efficacy of keyboard and singing music training programmes on reducing cognitive decline and other outcomes in older adults with Mild Cognitive Impairment (MCI).

Methods and analysis

This randomised, single-blind, controlled, parallel-group trial aims to enrol 432 individuals with MCI from the community in Sydney, Australia. Participants are randomly allocated to participate in either keyboard lessons, singing lessons or a film discussion control group once a week for 3 months. The primary objective is to assess the effectiveness of two music training programmes (keyboard and choral singing) for enhancing verbal memory after 3 months compared with control. Additionally, we will examine how these music-based interventions affect other aspects of cognition, mood, sleep, overall well-being, markers of brain plasticity and blood biomarkers of Alzheimer’s disease and neurodegeneration. Tertiary objectives are to identify factors that impact the success of the interventions, such as participation rates, engagement levels and key demographic and clinical features. Outcomes are collected at baseline and at 3 and 9 months. The primary endpoint analysis will include all randomised participants to estimate the treatment effect using intention-to-treat principles. Primary and secondary outcomes will be analysed using linear mixed models and effect size measures will be calculated.

This study will be the first robust, randomised controlled trial to assess the potential and relative value of music engagement for cognitive decline in high-risk MCI individuals, as well as broader effects on other markers of mental health, well-being and neurodegeneration. Co-designed with implementation in mind, the music interventions can potentially be delivered within memory clinic or community settings.

Ethics and dissemination

The Sydney University Human Research Ethics Committee (2023-026) has approved this protocol. The trial findings will be shared through conferences, publications and media.

Trial registration number

Australian and New Zealand Clinical Trials Registry (ACTRN12623000407695), Registered 21/04/2023 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385552

Protocol version

2.02 29/11/2024.

Standard medical care versus enhanced interdisciplinary care for implementation of positive airway pressure in youth with Down syndrome: a randomised controlled trial protocol

Por: Xanthopoulos · M. S. · Byars · K. · Meinzen-Derr · J. · Ebensen · A. · Xiao · R. · Heubi · C. · Gurbani · N. S. · Ishman · S. L. · Bradford · R. · Hicks · S. · Redline · S. · Tapia · I. E.
Introduction

Individuals with Down syndrome (DS) are predisposed to obstructive sleep apnoea (OSA) due to craniofacial features (eg, midface hypoplasia, glossoptosis) and studies have shown that the prevalence of OSA in this population is markedly increased compared with that of typically developing children. Adenotonsillectomy is considered the first-line treatment for childhood OSA. However, persistent OSA is common, thus many children with DS are referred for positive airway pressure (PAP) therapy initiation; PAP appears to be an important aspect of living with DS. PAP has been shown to be highly effective in the general population for treating OSA and improving OSA-associated neurobehavioural symptoms, such as quality of life, behaviour, mood, daytime sleepiness and school performance. However, PAP as a treatment for OSA has not been well-studied in children with DS. Therefore, we designed a multicentre randomised controlled trial recruiting children with DS and OSA at three academic institutions, aged 6–18 years, referred for PAP initiation to treat OSA.

Methods and analysis

86 participants will be randomised to a 6-month intensive behavioural intervention (INT) to improve PAP adherence versus standard clinical care and underwent standardised evaluations of quality of life, behaviour, attention, PAP adherence and healthcare utilisation at baseline, 6 months and 12 months.

Ethics and dissemination

This study has been approved by the institutional review board at Children’s Hospital of Philadelphia (IRB of record, IRB # 20–0 17 512). Cincinnati Children’s Medical Center and University of Miami delegated IRB review and approval responsibility to Children’s Hospital of Philadelphia through reliance agreements as mandated by National Institutes of Health (NIH). All participants will be minors; consent will be obtained from parents and assent from participants will be obtained when possible. The intervention tested in this trial is considered not greater than minimal risk, and no identifiable data will be reported. As required by the NIH, a data safety monitoring board (DSMB) has been formed, who will review and approve the protocol and any protocol changes prior to implementation. The study team will send biannual reports and hold a biannual meeting with the DSMB to review any safety and protocol concerns. Findings will be presented at national conferences pertinent to this topic and published in peer-reviewed medical journals. In addition, findings will be shared in the lay format with DS associations around the world and used for training of healthcare providers and trainees (R25HD118212). Further, data collected will be deposited in a repository (National Sleep Research Resource; sleepdata.org) after completion of the study to maximise use by scientific community.

Trial registration number

NCT04132999.

Tiny Bites, a digital health intervention delivered in early childhood education and care centres to support educators and caregivers to prevent childhood obesity: study protocol for a cluster randomised controlled trial

Por: Yoong · S. L. · Lum · M. · Leung · G. K. W. · Pearson · N. · Truby · H. · Dix · C. · Moumin · N. A. · Wolfenden · L. · Ananthapavan · J. · Grady · A. · Wiggers · J. · Delaney · T. · Rychetnik · L. · Romiti · M. · Lamont · H. · Stanley · S. · Lim · M. · Oldmeadow · C. · Mastersson · N. · Suth
Introduction

Infant feeding practices in the first 2 years of life are linked to long-term weight trajectories. Despite the importance of obesity prevention interventions, there are no randomised controlled trials (RCTs) evaluating early childhood education and care (ECEC) and primary caregiver-targeted interventions on child weight and feeding outcomes.

Aim

To assess the efficacy of an 18-month digital health intervention (Tiny Bites) delivered to ECEC services and primary caregivers of children aged 4 to ≤12 months on child age-adjusted and sex-adjusted body mass index-for-age z-score (zBMI) relative to usual care control in the Hunter New England (HNE) region of New South Wales, Australia.

Methods and analysis

This type 1 hybrid cluster RCT will include up to 60 ECEC services and 540 children/caregiver dyads. The intervention supports ECEC services and caregivers to deliver recommended responsive feeding practices to infants. ECEC services will receive access to an online assessment platform, training and resources, and implementation support. Primary caregivers will receive text messages, monthly e-newsletters, online links and direct communication from ECEC services. We will assess the impact on child zBMI at 18-month follow-up. Secondary outcomes include duration of consuming any breastmilk, child diet and caregiver responsive feeding practices. We will also assess ECEC policy and practice implementation related to targeted feeding practices, programme cost effectiveness, adverse effects and engagement with the programme (ECECs and caregivers). For the primary outcome, between-group differences will be assessed for paired data using two-level hierarchical linear regression models.

Ethics and dissemination

Ethics approval has been provided by HNE Human Research Ethics Committee (HREC) (2023/ETH01158), Deakin University (2024-202) and University of Newcastle HREC (R-2024-0039). Trial results will be submitted for publication in peer-reviewed journals, presented at scientific conferences locally and internationally and to relevant practice stakeholders.

Trial registration number

ACTRN12624000576527.

Long-term recovery from post-traumatic neck pain: protocol for a prospective cohort study in the emergency department

Por: Lynaes · C. · Ravn · S. L. · Skou · S. T. · Mogensen · C. B. · Arvig · M. D. · Christensen · S. W. M. · Sterling · M. · Andersen · T. E.
Introduction

Post-traumatic neck pain is common, representing a substantial human and societal burden. About 15%–25% of individuals involved in an accident causing whiplash continue to experience moderate-to-severe symptoms and functional impairment 1 year post-trauma. Factors such as age, high pain intensity, hypersensitivity to pain and early post-traumatic hyperarousal are associated with persistent neck pain. However, multiple questions remain unanswered regarding how best to improve early care. As such, research on recovery patterns (including indicators for health economic burden) and their predictors is still needed, including biomarkers for pre-traumatic and peri-traumatic stress, and the value of early prediction tools.

Methods and analysis

This prospective cohort study will include 100 participants (18 years) suffering from post-traumatic neck pain sustained within 72 hours of an accident. At baseline (a combination of inclusion and 1 week assessment), eligible participants will undergo a thorough evaluation, including assessment of descriptive characteristics, self-reported variables (eg, pain, disability, sleep quality and post-traumatic stress), biomarkers (eg, heart rate variability (HRV) and hair cortisol) and clinical tests (eg, cervical range of motion). Follow-up will be conducted at 3, 6 and 12 months post-trauma. Further, register data (eg, data on labour market attachment) will be added for the period. Among other methods, a receiver operating characteristic (ROC) curve and multivariable regression analyses will be used to evaluate performance and associations of the prediction tools and their associations with measures of HRV.

The sample size calculation is based on previous studies, estimating that 15% of participants will develop moderate-to-severe ongoing symptoms. Using a conservative estimate, 64 participants are needed to achieve a statistical power of 90% with an expected area under the curve of 0.80. Accounting for a 25% loss to follow-up, 80 participants are required. For regression analysis, 100 participants will be included. The prediction tool will be validated using ROC analysis, sensitivity and specificity. Logistic regression models will be performed with and without biomarkers and pain sensitivity. Health economic costs will be compared across groups. Multivariable regression will examine the link between HRV and post-traumatic stress disorder, adjusting for confounders and a moderation analysis will assess hair cortisol as a potential moderator.

Ethics and dissemination

The study is approved by the Regional Committee on Health Research Ethics of Southern Denmark (S-20230037). Due to the acute nature of recruitment, the study design does not allow for a 24-hour reflection period; however, this approach has been approved by the Committee.

Study results will be published in peer-reviewed journals and disseminated through non-scientific outlets, including patient and professional publications, press releases and social media. If effective, workshops for clinicians will be organised. Results will be published regardless of outcome, with coauthorships following ICMJE guidelines.

Trial registration number

NCT06176209.

State of Ohio Adversity and Resilience (SOAR) study protocol: a comprehensive, multimodal, family-based, longitudinal observational investigation of risk and resilience in mental health and substance use disorders

Por: King · A. P. · Langenecker · S. · Gorka · S. M. · Turner · J. · Wang · L. · Wastler · H. · Gonzalez · M. · Christian · L. M. · Keck · C. · Olsen · R. · Kim · H. · Klamer · B. · Fernandez · S. · Adler · C. · Andari · E. · Barrenger · S. L. · Bonfine · N. · Bozzay · M. · Brown · S. L. · Browni
Introduction

Deaths related to drug overdose and suicide in the USA have increased 500% and 35%, respectively, over the last two decades. The human and economic costs to society associated with these ‘deaths of despair’ are immense. Great efforts and substantial investments have been made in treatment and prevention, yet these efforts have not abated these increasing trajectories of deaths over time. The COVID-19 pandemic has exacerbated and highlighted these problems. Notably, some geographical areas (eg, Appalachia, farmland) and some communities (eg, low-income persons, ‘essential workers’, minoritised populations) have been disproportionately affected. Risk factors have been identified for substance use and suicide deaths: forms of adversity, neglect, opportunity indexes and trauma. Yet, the biological, psychological and social mechanisms driving risk are not uniform. Notably, most people exposed to risk factors do not become symptomatic and could broadly be considered resilient. Achieving a better understanding of biological, psychological and social mechanisms underlying both pathology and resilience will be crucial for improving approaches for prevention and treatment and creating precision medicine approaches for more efficient and effective treatment.

Methods and analysis

The State of Ohio Adversity and Resilience (SOAR) study is a prospective, longitudinal, multimodal, integrated familial study designed to identify biological, psychological and social risk and resilience factors and processes leading to mental health disorders, substance use disorders, substance overdose, suicide and associated psychological/medical comorbidities which reduce life expectancy and quality of life. It includes two nested longitudinal samples: (1) WD Survey: an address-based random population epidemiological sample of 15 000 individuals (unique households) representative of the state of Ohio assessed for psychosocial, psychiatric, behavioural health and substance use factors and (2) Brain Health Study: a family-based, multimodal, deep-phenotyping study conducted in 1200 families (up to 3600 persons aged 12–72 years) including MRI, electroencephalography, blood biomarkers and psychiatric diagnostic interviews, as well as neuropsychological, psychosocial functioning and family/community history, dynamics and support assessments. SOAR is designed to discover, develop and deploy advanced predictive analytics and interventions to transform mental health prevention, diagnosis, treatment and recovery.

Ethics and dissemination

All participants will provide written informed consent (or parental permission and assent for minors). The study was approved by The Ohio State University Institutional Review Board (study numbers 2023H0316 (Brain Health) and 2023H0350 (Wellness Survey). The Brain Health study was also approved by institutional review boards at each partnering institution involved in conducting participant assessments. Findings will be disseminated to academic peers, clinicians and healthcare consumers, policymakers and the general public, using local and international academic channels (academic journals, evidence briefs and conferences) and outreach (workshops and seminars).

Early-stage cost-utility analysis of novel diagnostic tests for giant cell arteritis: a modelling study in UK secondary care

Por: Yang · M. · Cocco · P. · Mackie · S. L. · Morgan · A. W.
Objective

To identify the key characteristics required for hypothetical diagnostic tests to be cost-effective for diagnosing giant cell arteritis (GCA).

Design

Combined decision tree and Markov cohort state-transition models were used to evaluate the cost-utility of new diagnostic tests compared with the standard pathways of biopsy and clinical judgement, with and without ultrasound. Input parameters were derived from secondary data and expert opinions. The analysis adopted a lifetime horizon and the UK National Health Service (NHS) perspective, using a willingness-to-pay threshold of £20 000 per quality-adjusted life year (QALY). Bivariate deterministic sensitivity analyses identified the maximum test price at varying diagnostic performance levels, and probabilistic sensitivity analyses over 5000 simulations provided 95% CIs.

Setting

UK.

Participants

Patients with symptoms suggestive of GCA.

Main outcome measure

Percentage of GCA-related and glucocorticoid-related complications avoided, maximum test price and incremental QALYs at each sensitivity and specificity combination.

Results

A biomarker test incorporated into a hypothetical diagnostic pathway with perfect accuracy (100% sensitivity and specificity) can be priced up to £7245 (95% CI £5763 to £8727) and remain cost-effective compared with a standard pathway of temporal artery biopsy and clinical judgement. Against a standard pathway including ultrasound, the biomarker test can be priced up to £8606 (£6741 to £10 471). The test’s value was more strongly influenced by improvements in specificity than in sensitivity. The maximum prices decreased with earlier starting age, lower clinician adherence, shorter time horizons and shorter durations of glucocorticoid-related effects.

Conclusions

The study highlights the potential for hypothetical tests to improve GCA diagnosis and reduce glucocorticoid toxicity, while demonstrating their market viability for use within the NHS. It also illustrates how early-stage economic models can provide valuable insights into potential cost-effectiveness to inform the test development process.

Healthcare professionals views of physiotherapy after cardiac surgery in children with congenital heart disease: a UK and Ireland survey

Por: Clarke · S. L. · Shkurka · E. · Menzies · J. C. · Drury · N. E.
Objectives

To understand healthcare professionals’ views on current physiotherapy service provision in children with congenital heart disease (CHD), how physiotherapy could be better used post-cardiac surgery and perceived barriers to service expansion.

Design

Cross-sectional survey using a one-off self-completed online questionnaire, with open and closed questions, in June–August 2024.

Setting

Each of the 12 level 1 paediatric cardiac surgical centres in the UK National Health Service and Children’s Health Ireland.

Participants

Healthcare professionals providing clinical care to children undergoing cardiac surgery.

Results

80 responses were obtained, with at least one response from each centre. Healthcare professionals conduct motor, developmental and functional evaluations across all age groups, with referrals to physiotherapy primarily based on physical examination (39, 87%). They expressed dissatisfaction with community physiotherapy services (64, 81%) compared with inpatient services (29, 36%), although they indicated that expanding services would positively impact patients and families. There is a lack of consensus regarding intervention frequency, duration and which patient groups should be prioritised. Respondents identified a lack of funding as the primary barrier to service expansion (76, 95%). Reported barriers for families included volume of medical appointments (69, 86%), transportation (66, 83%) and finances (62, 78%).

Conclusions

Healthcare professionals appreciate the positive impact physiotherapy can have on post-surgical management of children with CHD. The importance of expanding services was emphasised. However, to effectively support clinical practice, it is crucial to understand which patient groups should be prioritised and at what stage, as well as determining the optimal amount of physiotherapy that positively impacts patient outcomes.

Scoping review protocol on oral health research in Malaysia

Por: Kueh · B.-L. · Chong · A. S. L. · Zainal · M. R. · Lai · W.-H. · Subramaniam · S. · Sathasivam · H. P. · Yugaraj · P. · Muhamad · N. A.
Introduction

Oral health research provides evidence for policy and practice, yet no study has comprehensively mapped the scope of oral health research in Malaysia. The COVID-19 pandemic has also created a great impact on oral healthcare in Malaysia, including the dental care delivery. Additionally, there is a notable lack of research focusing on oral health during and after the COVID-19 pandemic. Therefore, this scoping review will aim to map the landscape of oral health research conducted in Malaysia and identify key topics, study designs, populations studied and gaps in the literature, in order to inform future research priorities and policy, particularly in the post-COVID-19 era.

Methods and analysis

The methodology draws on Arksey and O’Malleys’ seminal framework for the scoping review and will be reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Review (PRISMA-ScR) guidelines. We will search five major electronic databases—PubMed, Scopus, ProQuest, Cochrane and Web of Science—as well as selected grey literature sources (eg, theses, dissertations and conference proceedings) for studies published in English from January 2014 to December 2024. Studies of any design related to oral health in Malaysia will be included. Two reviewers will be performing title and abstract screening, in which they will be working independently. The included publication will undergo a full-text review, and references cited in these studies will be examined following the inclusion criteria. The PRISMA-ScR flow diagram will be used as a guide throughout the process. Data will be extracted, analysed and charted according to key categories identified in the included publications. A narrative synthesis and descriptive statistics will be presented.

Ethics and dissemination

The results of this scoping review will illustrate an overview and provide a better understanding regarding the oral health research in the Malaysian context; whether research has already been conducted, is currently ongoing and is still needed; and which areas should be prioritised for future investigation. As this review will use publicly available literature, formal ethics approval will not be required. The findings will be submitted for publication in an open-access peer-reviewed journal, presented at national and regional conferences and shared with Malaysian dental professional bodies and relevant stakeholders.

Trial registration number

The protocol of this scoping review is registered with the Open Science Framework and is available at osf.io/hjq6m.

Descriptive study of cholera-related deaths in communities during Zambias 2023-2024 outbreak: key insights

Por: Mweso · O. · Shula · A. · Sialubanje · C. · Chanda · S. L. · Shinjeka · T. · Mwangilwa · K. · Chirwa · L. · Kabwe · D. · Mwanza · J. · Mbewe · N. · Fwoloshi · S. · Sinyange · N. · Kapina · M. · Gebregiorgis · A. · Shikanga · O. · Mwale · M. · Nyirenda · M. · Lisulo · P. · Chipimo · P. · Mube
Objectives

The study sought to understand the characteristics of community deaths due to cholera in Zambia. We sought to examine the drivers of mortality from cholera among communities in Zambia’s 2023–2024 outbreak.

Design/setting

This is a descriptive study of the characteristics of community deaths due to cholera in three provinces in Zambia. Routine surveillance data collected between 14 October 2023 and 16 April 2024, comprising a national line list of cholera deaths, were used for this study.

Participants

178 participants were included in the study and completed it. All community deaths on the line list were eligible for inclusion. This comprised: deceased individuals whose death was associated with cholera or who met the national cholera case definition (suspected or confirmed); death occurring in the community, en route or on arrival to a health facility prior to admission; and death must have occurred between 14 October 2023 and 16 April 2024. Deceased individuals whose family members could not be traced or did not consent to participate in the interview were excluded.

Primary and secondary outcome measures

The primary outcome was identifying characteristics of cholera-related community deaths. There were no secondary outcomes measured.

Results

Among 178 community deaths due to cholera, the majority were males (61.8%), with the highest mortality in adults aged 35–49 years (22.5%). Over half of the deaths occurred on arrival at healthcare facilities due to delays influenced by socioeconomic barriers. Comorbidities such as HIV/AIDS and hypertension were present in 23% of cases.

Conclusions

The study found that males, death on arrival at healthcare facilities, delays in seeking healthcare and comorbidities such as HIV/AIDS and hypertension were more frequently observed among those who died due to cholera in the community. These findings highlight the need for enhanced early care-seeking behaviours, improved access to timely treatment and targeted interventions for individuals with comorbidities to potentially reduce cholera mortality.

Adaptation drivers of evidence-based brief advice/counselling for tobacco use in high-reach, low-resource settings in Mumbai: a qualitative exploration with patients, practitioners and policymakers

Por: Ramanadhan · S. · Mahtani · S. L. · DCosta · M. · Mandal · G. · Jagiasi · D. · Chawla · R. · Minsky · S. · Xuan · Z. · Mulhern Lopez · M. · Gupte · H.
Introduction

Tobacco use accounts for approximately 1.35 million deaths annually in India, disproportionately affecting low-income individuals, men, rural residents, those without formal education and groups of low socioeconomic status (SES). Despite progress in tobacco control, scalable, low-cost solutions, such as brief advice interventions, are needed. This study explored priority implementation determinants for adapting an evidence-based brief advice/counselling intervention for high-reach, low-resource settings in Mumbai, India. The focal settings (health-focused and tuberculosis-focused non-governmental organisations (Health NGOs and TB NGOs) and dental clinics) served low-SES populations.

Methods

Mumbai-based and US-based team members conducted a qualitative study employing semistructured interviews to gather data from four groups connected to Health and TB NGOs and dental clinics: (1) 15 patients, (2) 33 practitioners, (3) nine practice leaders and (4) three policymakers. We used a team-based, critical, reflexive thematic analysis approach to analysis, grounded in the Exploration, Preparation, Implementation and Sustainment framework. We managed data with Nvivo software.

Results

Participants were supportive but highlighted diverse challenges and supports required for implementing the intervention in these diverse settings. First, many noted that societal constraints such as economic insecurity and cultural factors were expected to limit tobacco control efforts for low-SES populations. Second, setting-specific intervention adaptations were identified as necessary to support integration and ensure access to support for all patients. Various participant groups highlighted different adaptation areas. For example, patients noted that tobacco was part of their routines and social lives, practitioners emphasised the need to design implementation plans that support integration alongside existing needs, and policymakers highlighted the need for uniform implementation strategies.

Conclusion

Adapting brief advice/counselling interventions for Health NGOs, TB NGOs and dental clinics in Mumbai will require strategic communication to support buy-in, thoughtful workflow integration and changes to funding and support mechanisms for organisations so meaningful reductions in tobacco use can be achieved among low-SES groups. In other words, there is a need to adapt both the intervention and the implementing system to allow for brief advice/counselling to contribute to broader tobacco control efforts.

Trial registration

R01 CA230355.

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.

Adherence to the recommended diabetic retinopathy screening guidelines in pregnant women with pregestational diabetes: a cross-sectional survey study

Por: Widyaputri · F. · Rogers · S. L. · Nankervis · A. J. · Conn · J. J. · Shub · A. · Staffieri · S. E. · Sasongko · M. B. · Fagan · X. J. · Symons · R. C. A. · Lim · L. L.
Objective

Diabetic retinopathy (DR) in pregnancy can cause blindness. National guidelines recommend at least one eye examination in early pregnancy, then ideally 3-monthly, through to the postpartum for pregnant women with pregestational diabetes. Here we examined adherence rates, barriers and enablers to recommended DR screening guidelines.

Design

Cross-sectional survey study, as part of a larger prospective cohort study.

Setting

Participants were recruited from two tertiary maternity hospitals in Melbourne, Australia.

Participants

Of the 173 pregnant women with type 1 (T1D) or type 2 diabetes (T2D) in the main cohort study, with an additional four who participated solely in this survey study, 130 (74.3%) completed the survey.

Primary and secondary outcome measures

This study calculated rates of adherence to guideline-recommended DR screening schedules and collected data on the enablers and barriers to attendance using a modified Compliance with Annual Diabetic Eye Exams Survey. Each of the 5-point Likert-scale survey items was compared between adherent and non-adherent participants using the Wilcoxon rank-sum test and logistic regression models were constructed to quantify associations as ORs.

Results

A retinal assessment was undertaken at least once during pregnancy in 86.3% of participants, but only 40.9% attended during their first trimester and only 21.2% attended the recommended number of examinations. Competing priorities were the main barriers to adherence, with eye examinations ranked as the fourth priority (IQR 4th–5th) among other health appointments during pregnancy. Meanwhile, knowledge of the benefits of eye screening examinations, eye-check reminders and support from relatives was identified as enablers.

Conclusions

Despite the risk of worsening DR during pregnancy, less than half of the participants adhered to recommended screening guidelines, suggesting that eye health is not a priority. Proactive measures to integrate care are needed to prevent visual loss in this growing population.

Relationship between anti-diabetic medication use and glycaemic control: a retrospective diabetes registry-based cohort study in Singapore

Por: Chan · S. L. · Yap · C. J. Q. · Xu · Y. · Chia · S. Y. · Mohamed Salim · N. N. B. · Lim · D. M. · Choke · E. · Carmody · D. · Tan · G. C. S. · Goh · S.-Y. · Bee · Y. M. · Chong · T. T.
Objective

This study aimed to determine the association between diabetes mellitus (DM) medication use and glycaemic control.

Design

This was a retrospective diabetes registry-based cohort study.

Setting

Singapore.

Participants

Patients aged 18 and above with incident DM in the SingHealth Diabetes Registry from 2013 to 2020 were included. The entire study period included a 1 year baseline period, a 1 year observation period and a 3 month outcome period.

Outcome measures

Drug use was measured using the proportion of days covered (PDC), and the changes in glycated haemoglobin (HbA1c) between the outcome and baseline periods were assessed. The associations between baseline HbA1c and PDC ≥0.80 and between PDC and change in HbA1c were analysed using logistic regression and the Kruskal–Wallis test, respectively.

Results

Of 184 646 unique patients in the registry from 2013 to 2020, 36 314 met the inclusion and exclusion criteria and were included in the analysis. The median PDC for any DM drug, oral DM drugs and insulin during the observation period was 20.3%, 16.8% and 0%, respectively. Those who had good glycaemic control at baseline were less likely to receive DM drugs and those with poor baseline glycaemic control or missing baseline HbA1c were more likely to be consistent users (PDC >80%) (px 10-16).

Conclusion

The relationship between DM drug use and glycaemic control is complex and non-monotonic. Higher PDC for any DM drug and oral DM drugs during the observation period was significantly associated with clinically relevant HbA1c improvements.

Access to multidisciplinary outpatient heart failure clinics in Qatar: a qualitative study from the perspectives of patients and cardiologists

Por: Hajaj · A. · Grace · S. L. · Hamed Badr · A. M. · Hadi · M. A. · Abdel-Rahman · M. E. · Babu · G. R. · Turk-Adawi · K.
Objective

Heart failure clinics (HFCs) are associated with increased survival rates, lower hospitalisation and improved quality of life. This study investigated factors influencing patient access to multidisciplinary outpatient HFCs from the perspective of patients and cardiologists.

Design

This was a qualitative study. A trained researcher conducted semistructured face-to-face interviews with patients and online interviews with cardiologists. Interviews, conducted between March and October 2023, were audio-recorded. Transcripts were cleaned (deidentification, translation verification) and analysed by two trained researchers independently using systematic text condensation in NVivo v12. Codes were derived from the transcripts and grouped and organised into themes. Two authors independently coded data, reconciling disagreements with the senior author, followed by respondent validation. Member checking ensued.

Setting

Outpatient multidisciplinary HFCs in Qatar.

Participants

A purposive sample of patients diagnosed with heart failure who had attended at least one HFC appointment at Qatar’s Heart Hospital were approached in person or via phone, and cardiologists with the authority to make referrals to these clinics via the electronic medical record system were emailed; interviews ensued until theme saturation was achieved.

Results

26 individuals (14 patients and 12 cardiologists) participated in the interviews. Four major themes were identified: health system organisation (subthemes: benefits, HFC triage criteria, need/capacity), HFC referral processes (subthemes: electronic record system, patient communication and education), care continuity and communication (subthemes: patient navigators, clinician preferences) and access challenges (subthemes: transportation, costs).

Conclusions

Resources are needed to expand HFC capacity and coverage, leverage electronic medical record tools as well as telehealth, educate physicians and patients on referral guidelines and processes and engage primary care to ultimately improve patient outcomes.

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.

Cardiometabolic function in Offspring, Mother and Placenta after Assisted Reproductive Technology (COMPART): a prospective cohort study

Por: Kjaer · A. S. L. · Vestager · M. L. · Blixenkrone-Moller · E. · Asserhoj · L. L. · Kloppenborg · J. T. · Lossl · K. · Ekelund · C. K. · Rode · L. · Hjort · L. · Hoffmann · E. R. · Lyng Forman · J. · Beck Jensen · R. · Pinborg · A.
Introduction

The Cardiometabolic function in Offspring, Mother and Placenta after Assisted Reproductive Technology (COMPART) study is a prospective cohort study aiming to explore health outcomes in mothers and children following assisted reproductive technology (ART), with a particular focus on frozen embryo transfer (FET) versus fresh embryo transfer (fresh-ET). The increasing prevalence of ART and FET emphasises the need to assess potential health risks associated with the procedures, both in pregnancy, such as pre-eclampsia and large for gestational age offspring, and in the children, such as obesity and cardiometabolic dysfunction.

Methods and analysis

The cohort will include 600 pregnant women, their potential partner and their offspring in a 1:1:1 ratio of pregnancies achieved after ART with FET, ART with fresh-ET and women who conceived naturally. The study will involve extensive data collection from electronic medical records; parental questionnaires; biochemical, genetic and epigenetic analyses in blood, urine and placental tissue; and medical imaging (fetal ultrasound and PEA POD scan) and clinical examinations. Outcomes are grouped into six work packages (WPs) related to fetal growth (WP1), pregnancy (WP2), placenta (WP3), offspring (WP4), genetics (WP5) and epigenetics (WP6).

Ethics and dissemination

The COMPART study aims to provide valuable insights into the impact of ART and FET on maternal and offspring health and the underlying mechanisms responsible. The study seeks to advance reproductive medicine, shape clinical practice and guidelines and ultimately ensure maternal-fetal health following ART. The study has been approved by the Danish Ethics Committee (H-23071266; February 2024).

Trial registration number

NCT06334003

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.

Modelling US health equity impacts of emicizumab for severe haemophilia A: aggregate distributional cost-effectiveness analysis

Por: Majda · T. · Lee · J. S. · Curtis · R. · Kowal · S. L.
Objectives

Emicizumab is the first bispecific antibody approved for prophylaxis in people with haemophilia A with or without factor VIII inhibitors. Aggregate distributional cost-effectiveness analysis assesses health equity impacts by evaluating how health effects and costs from funding an intervention are distributed among population subgroups. The objective was to evaluate how funding emicizumab for people with severe haemophilia A (PwSHA) impacts population health and health disparities in the USA.

Design

Population-level model of PwSHA from the perspective of the US healthcare system, using published sources and considering a lifetime time horizon.

Intervention

Emicizumab versus other haemophilia A prophylaxis treatments.

Primary outcome measures

Quality-adjusted life-years (QALYs) gained and change in Atkinson index of inequality in quality-adjusted life expectancy.

Results

When an estimated 6512 PwSHA in the USA were treated with emicizumab, the US healthcare system would save US$160 billion over those individuals’ lifetimes. If these cost savings fund additional healthcare interventions in the overall population, funding emicizumab would improve overall US population health (1 068 903 QALYs gained, using a threshold of US$150 000/QALY) and reduce existing overall US inequities (–0.01% on the Atkinson index).

In all scenarios tested for sensitivity, increased emicizumab and prophylaxis utilisation led to further reductions in health disparities and greater increases in population health. Results were robust to deterministic variations in the allocation of cost savings due to emicizumab use.

Conclusion

Funding emicizumab treatments for PwSHA improves overall population health and reduces overall health inequities in the USA. Cost savings from the use of emicizumab free up important resources that can be leveraged to support other healthcare interventions, but decisions on how these funds are used have large consequences for equity.

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