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Household dynamics of maternal caregiving and agricultural labour in complementary feeding practices in rural farming communities in Geita Region, Tanzania: a qualitative study

Por: Mashala · M. S. · Mahiti · G. R.
Objective

Inappropriate complementary feeding contributes to child undernutrition, even in food-secure areas. This paradox highlights the need to look beyond food availability and examine the household-level mechanisms that shape everyday feeding decisions in the farming and food-secure settings. The objective of this study was to explore the household dynamics of maternal caregiving and agricultural labour in complementary feeding practices in rural farming communities in Geita.

Design

Phenomenology study design was employed to explore the lived experiences and perceptions of mothers regarding complementary feeding practices.

Setting

Rural farming communities in Geita Region, Tanzania.

Participants

Mothers of children aged 6–23 months were purposively selected to participate in seven in-depth interviews and two focus group discussions.

Results

In these farming communities, four household-level factors were found to influence complementary feeding practices: maternal responsibility and farming obligations, carrying children and porridge to the farms, limited paternal involvement, fatigue due to prolonged farm work, reliance on elder siblings for childcare and fear of judgement or sanctions for late arrival at the farm. Farming emerged as a cross-cutting theme that intersected all these sub-themes.

Conclusion

Mothers described complementary feeding practices as closely linked to household division of labour, caregiving arrangements and the demands of farming activities that shaped daily routines. These findings suggest the need for context-sensitive strategies that consider intra-household roles and the time constraints associated with subsistence farming.

Statistical analysis plan for the Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention (SAVE-O2 AI) trial: protocol

Por: Douin · D. J. · Rice · J. D. · Xiao · M. · Beaty · L. · Guo · C. · Withers · C. · Sullivan · A. · Anderson · E. L. · Cheng · A. C. · Banasiewicz · M. K. · Semler · M. W. · Lloyd · B. D. · Maiga · A. · Gibbs · K. W. · Stettler · G. R. · Khan · A. · Sally · M. B. · Wright · F. L. · Aggarwal
Introduction

Administering supplemental oxygen to prevent hypoxaemia is a fundamental treatment for patients hospitalised with acute injury or illness. However, the amount of oxygen administered frequently exceeds that needed to maintain normoxaemia, causing patients to experience hyperoxaemia and wasting supplemental oxygen. Closed-loop, autonomous oxygen titration systems are designed to optimise oxygen delivery by administering the lowest possible oxygen flow that maintains peripheral oxygen saturation (SpO2) within a predefined range. For adults hospitalised with an acute injury or illness, it remains uncertain whether the use of a closed-loop, autonomous oxygen titration system safely increases the proportion of time spent in normoxaemia (SpO2 90%–96%) compared with usual care.

Methods and analysis

The Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention trial is a multicentre, unblinded, parallel-group, randomised trial being conducted at four level 1 trauma centres in the USA. The trial compares an autonomous oxygen titration system versus usual care among 300 adults hospitalised for major trauma, burn, acute care surgery or acute respiratory illness. The primary outcome is the proportion of patient-time spent within the targeted normoxaemia range (SpO2 90%–96%) as measured by continuous non-invasive pulse oximetry, during the first 72 hours after randomisation. Secondary outcomes include the amount of supplemental oxygen administered and the proportion of time spent in hypoxaemia (SpO22 >96%). Specifying the protocol and statistical analysis plan before the conclusion of enrolment increases the rigour, reproducibility and interpretability of the trial. Enrolment began on 6 May 2024.

Ethics and dissemination

The trial protocol was approved by the single institutional review board at the University of Colorado School of Medicine and the Office of Human Research Oversight at the Department of Defense. We will present the results at scientific conferences and submit them for publication in a peer-reviewed journal.

Trial registration number

NCT06374225.

Attitudes towards supervised consumption sites and e-health overdose response interventions: development and reliability of the Canadian National Questionnaire on Overdose Monitoring (CNQOM)

Por: Rider · N. · Seo · B. · Viste · D. · Rioux · W. · Sedaghat · N. · Pan · B. · Al Hamarneh · Y. N. · McCormack · G. R. · Aghajafari · F. · McDougall · L. · Ghosh · S. M.
Objective

To detail the development of the Canadian National Questionnaire on Overdose Monitoring (CNQOM), a questionnaire aimed at assessing the perspectives of key stakeholders towards elements of overdose prevention interventions—supervised consumption sites (SCSs) and overdose hotlines and applications (ORHAs).

Design

Cross-sectional survey.

Setting

Canadian health system.

Participants

English or French speaking adults from four key informant groups: people who use substances (PWUS), health professionals, emergency responders and the general public.

Outcome measures

Test–retest reliability of CNQOM items.

Methods

A novel questionnaire was developed. Item development followed a standard approach, with face validity verified by representatives from the four informant groups. Input from experts in harm reduction and addiction medicine enhanced content and face validity of the questionnaire. A rigorous response validation approach was undertaken to ensure respondents were human and from Canada. Test–retest reliability items were assessed using Spearman’s rank correlation, Wilcoxon rank-sum test and Cohen’s kappa.

Results

After data cleaning and response validation, 4445 valid responses were obtained from the four key informant groups. Respondents represented a range of sociodemographic backgrounds and housing scenarios from all provinces and territories in Canada. Test–retest reliability was assessed using a small subsample of 142 participants (primarily from general public informants). Questionnaire items demonstrated slight to substantial stability in responses (kappa coefficients: 0.15–0.58; Spearman’s r: 0.08–0.66).

Conclusions

The CNQOM is the first online questionnaire in Canada designed to capture perspectives and attitudes towards specific elements of SCSs and ORHAs among diverse key informant groups. Our questionnaire was administered to a large, geographically diverse sample and designed to capture the perspectives of four key informant groups. Lower than expected test–retest reliability may be explained by lack of participant familiarity with SCS and especially ORHAs and the impersonal nature of the instrument content among some respondents. Future work will elucidate key informant perspectives on these services based on the data.

Surgery versus conservative management for severe pectus excavatum (RESTORE): protocol for a multicentre, randomised, controlled superiority trial

Por: Maier · R. · Dunning · J. · Wason · J. · Chadwick · T. · Bryant · A. · Fernandez-Garcia · C. · Vale · L. · Danjoux · G. R. · Wallace · G. · Levett-Renton · A. · Naidu · B. · Pryor · C. · McCulloch · P. · Thursfield · R. · Wyllie · J. · Chang · L. · Marsay · L. · Akowuah · E.
Introduction

Severe pectus excavatum (PE) may impair cardiopulmonary and physical function. The effectiveness of surgical treatment to correct PE and restore physical function is widely debated due to a lack of high-quality comparative evidence. The RESTORE trial aims to determine the clinical and cost-effectiveness of corrective surgery for severe PE compared with conservative management for the first time in a randomised controlled trial (RCT).

Methods and analysis

RESTORE is a pragmatic, multicentre, RCT with an embedded observational cohort. 200 participants aged ≥12 years with severe PE will be recruited at around 12 National Health Service cardiothoracic surgical centres in England. Participants will be randomised 1:1 to receive either surgery within 3 months of randomisation (intervention arm) or no surgery until after the primary outcome measurement at 1 year (comparator arm). The primary outcome is change in physical functioning from baseline to 1 year as measured by the Short Form Health Survey (SF-36v2) physical function score. The primary economic outcome is cost-effectiveness. The key secondary outcome is change in % predicted VO2peak at 1 year measured by cardiopulmonary exercise test (CPET). Outcomes will be assessed at 1 year post-randomisation in the comparator arm and 1 year post-surgery in the intervention arm. The primary analyses will be undertaken on an intention-to-treat population using a linear mixed-effects model, adjusted for stratification variables via a binary covariate. Other secondary outcomes will include change from baseline of cardiopulmonary function (CPET and spirometry), health-related quality of life using the EuroQol 5 Dimension 5 Level (EQ-5D-5L) and SF-36v2 questionnaires, Hospital Anxiety and Depression Scale and disease specific symptoms (Phoenix Comprehensive Assessment for Pectus Excavatum Symptoms and Pectus Excavatum Evaluation Questionnaire). Adverse events, complications from surgery and operative technical success (Haller and Compression Indices from preoperative and postoperative CT scans) will also be assessed. Health economic analysis will estimate the incremental cost per quality adjusted life year at 1 year.

Ethics and dissemination

The trial was approved by East of Scotland Research and Ethics Service (24/ES/0034). Participants who are ≥16 years of age will be required to provide written informed consent. For participants

Trial registration number

ISRCTN11359779.

Keratorefractive lenticule extraction (KLEx) versus femtosecond laser-assisted in situ keratomileusis (FS-LASIK) for the treatment of myopia and compound myopic astigmatism: study protocol of a randomised clinical trial in Mexico

Introduction

Kerato-lenticule extraction (KLEx) is a refractive surgery technique that, in contrast with femtosecond laser-assisted in situ keratomileusis (FS-LASIK), does not require the creation of a flap to correct refractive defects. The potential advantages of this technique are related to the absence of a flap and its complications. On the other hand, FS-LASIK is the most widely practised refractive surgery worldwide, as it offers excellent visual outcomes and is currently the gold standard of refractive surgery. The objective of this study is to compare the effectiveness and safety of KLEx versus FS-LASIK as a treatment option in patients with myopia or myopic astigmatism.

Methods and analysis

This double-masked, parallel-group, single-centre randomised clinical trial will enrol 80 eyes from adults with myopia or compound myopic astigmatism within the ranges sphere –0.50 to –12.00 D and cylinder –0.50 to –6.00 D, recruited at the Instituto de Oftalmología Conde de Valenciana, Mexico City, Mexico. Participants will be allocated to KLEx or FS-LASIK and assessed at baseline and 1 day, 1 week, 1, 3, 6 and 12 months postoperatively. The primary outcome is uncorrected visual acuity at all postoperative visits. Secondary outcomes include postoperative spherical equivalent, best-corrected visual acuity (BCVA), loss of ≥2 BCVA lines, the proportion of eyes within ±0.50 D of the refractive target, corneal aberrations over a 5 mm pupil, epithelial changes and adverse events. Participants and outcome assessors will be masked to the assigned surgical technique.

Ethics and dissemination

Participant confidentiality will be maintained with the publication of results. This study was approved by the research and ethics committee of the Instituto de Oftalmología Fundación de Asistencia Privada Conde Valenciana (CI-017-2024). The study results will be disseminated in scientific articles published in peer-reviewed journals and presented through research posters at national and international conferences.

Trial registration number

ClinicalTrials.gov registry (NCT06477081).

Associations between oral health behaviours, oral health, salivary biomarkers and clinical phenotype in individuals with alcohol use disorder: protocol for a longitudinal observational study

Por: Maki · K. A. · Xu · S. · Wallen · G. R. · Gerrard · C. · Sung · C. · Papneja · S. · Tuason · R. T. S. · Ramchandani · V. A. · Diazgranados · N. · Barb · J. J.
Introduction

Binge drinking in the previous month was reported in 23.5% of US adults, and 28.1 million adults met criteria for Alcohol Use Disorder (AUD) in 2023. Individuals with AUD face increased risks of oral health problems, including caries, periodontal disease and mucosal lesions. Poor oral hygiene, nutrition and dental care all contribute to these conditions, but individuals with AUD are often under-represented in oral health surveys. Understanding relationships between oral health behaviours, attitudes and general health is crucial for designing future interventions. This pilot aims to explore the relationship between oral and systemic health in subjects with AUD, focusing on oral health behaviours, salivary biomarkers and clinical phenotype, including systemic biomarkers of inflammation, to inform future research on oral–systemic interactions in AUD.

Methods and analysis

This protocol has two parts. Part 1 involves cognitive interviews to assess the content validity and interpretability of the Oral Health Behaviours Assessment (OHBA) questionnaire. Part 2 will collect biological and behavioural data from treatment-seeking patients with AUD and matched controls (age, sex and smoking status), including saliva, blood, dental exams, and health behaviour and symptom measures. Inpatients with AUD will provide biospecimens and answer symptom severity questionnaires at admission and again at the dental exam visit (7–12 days later), while controls will provide a single set of measures at their dental exam visit. Oral health will be assessed through structured dental and periodontal examinations, radiographs and validated questionnaires (including the OHBA). Additional data will include alcohol use history, psychiatric and medical history assessments, dietary recall, and measures of stress, sleep and mood to capture potential moderators of oral–systemic relationships. Biomarkers of inflammation and stress will be quantified from saliva and blood using immunoassays. Primary outcomes will compare oral health, salivary biomarkers and clinical measures between AUD and controls, while secondary outcomes will evaluate within-subject changes in patients with AUD during inpatient treatment and early abstinence.

Ethics and dissemination

This clinical protocol was approved by the National Institutes of Health Institutional Review Board (IRB #002005). Prior to enrolling, participants will be informed of the study purpose, risks and benefits, and study procedures, and evaluated for understanding prior to signing consent. Part 1 of the protocol is currently active and recruiting participants for cognitive interviews. The study findings will be disseminated through journals and conferences related to addiction medicine, psychology, immunology, neuroscience and dentistry. We expect the results of the pilot study will inform future research on oral health and salivary bioscience while also providing treatment-seeking patients with AUD targeted information on the importance of oral health behaviours for maintaining oral and systemic health.

Trial registration number

NCT06684483; preresults.

Leadership in the health professions in the Philippines: a scoping review protocol

Por: Gabrieles · M. · Lipana · A. G. R. · Dicolen · E.
Introduction

Research indicates that leadership in the health professions can facilitate improvement of quality and efficiency of healthcare services. In the Philippines, leadership in the health professions plays a critical role in driving improvements in healthcare delivery and health professions education. Thus, the landscape of leadership in the health professions merits continuous exploration and deeper understanding. This scoping review aims to explore the landscape of leadership in the health professions in the Philippines. The scoping review will include published and unpublished research papers of any kind, such as primary research studies, systematic reviews, meta-analyses, letters, guidelines, websites, blogs and grey literature that report about leadership in the health professions in the Philippines. Exclusions are leadership studies on the health professions that discuss the professions outside the scope and context of the practice.

Methods and analysis

The Joanna Briggs Institute (JBI) methodological framework for scoping review will be used in this review. A three-step search strategy will be used consisting of an initial search, full search and screening of reference lists. The databases that will be included are Cinahl Ultimate, Cochrane Library, Scopus, Embase, Emcare, Web of Science, JBI Evidence-based Practice Database, PubMed/Medline, ERIC, local journals and grey literature to determine pertinent sources about the topic. Sources searched will be screened by two independent reviewers and data will be extracted using a data extraction table. Disagreements will be resolved by a discussion through a third reviewer. The results of the search and the study inclusion process will be reported in full in the final scoping review and presented in a Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping review flow diagram. Search strategy using the included databases started in August to September 2025, data extraction will start by October 2025, data analysis will start by November 2025 and the review is expected to be completed by December 2025.

Ethics and dissemination

This study does not involve human participants and has been reviewed and classified for exempted review by the University of the Philippines Manila Research Ethics Board, which is a committee whose task is to make sure that research participants are protected from harm. The findings of the scoping review will be disseminated through conference presentations and publication in a scientific journal.

Perspectives of faculty, students and patients on clinical skills teaching in undergraduate medical education in Pakistan: a qualitative study

Por: Sohail · F. A. · Iqbal · M. · Malik · M. G. R. · Saeed · S.
Objectives

To explore the challenges and opportunities in clinical skills teaching and learning among faculty, final-year medical students and patients at a private medical university in Pakistan, within the context of a low- and middle-income country (LMIC) medical education system.

Design

An exploratory descriptive qualitative design using inductive thematic analysis utilising in-depth interviews and focus group discussions, framed within a metaphorical lens.

Setting

A single private-sector tertiary care teaching hospital and affiliated undergraduate medical college in an urban setting in Pakistan.

Participants

A total of 48 participants were included in the study: 12 clinical faculty members representing various disciplines and levels of experience, 16 final-year medical students and 10 house officers and 10 patients from adult inpatient wards. Participants were purposively selected to ensure maximum variation in perspectives.

Results

Six key metaphorical themes emerged, each reflecting both the challenges and opportunities within the clinical learning journey: (1) The Safety Harness—simulation as an opportunity for structured, risk-free skill development, yet limited by authenticity; (2) The Underwater Life—the irreplaceable but unpredictable nature of bedside learning in fostering empathy and communication; (3) The Stormy Seas—systemic and cultural barriers such as patient availability, gender constraints and limited faculty resources; (4) The Ship—students navigating self-development amid evolving expectations, digital distractions and shifting motivations; (5) The Engine Room Tools—balancing diverse teaching modalities while seeking optimal time distribution between simulation and bedside learning; and (6) The Guiding Compass—the pivotal role of clinical teachers as mentors and professional exemplars. Triangulated perspectives revealed that while structured simulation and bedside experiences complement one another, significant institutional, ethical and pedagogical challenges persist, many amplified by the realities of resource-limited LMIC settings.

Conclusions

This study underscores the complexities of clinical teaching and learning in an LMIC context, highlighting the need for a balanced, context-sensitive model that integrates simulation with authentic bedside exposure, supported by mentorship and reflective practice. Addressing structural and faculty-related barriers is essential to advancing equitable, patient-centred clinical education in resource-constrained environments.

Caregiving stress and biological aging measured by epigenetic clocks: protocol for a scoping review

Por: Lee · L. J. · Son · E. · Butera · G. · Park · J. · Hussain · T. · Wallen · G. R.
Introduction

Chronic caregiving stress accelerates biological aging, reflecting disease risk and mortality; however, the underlying mechanisms are poorly understood. Epigenetic clocks, which can be estimated from levels of DNA methylation in a subset of cytosine-phosphate-guanine loci in the genome, have been proposed as a promising biological age estimator. The objectives of this scoping review are to systematically scope the literature on the effects of stress on biological ageing measured by epigenetic clocks in family caregivers of patients diagnosed with cancer.

Methods and analysis

This review will be conducted following Joanna Briggs Institute methodology based on Arksey and O’Malley’s and Levac et al’s framework and reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for scoping reviews. Studies will be included if (1) the studies focus on unpaid family caregivers of patients diagnosed with cancer; (2) caregivers are adults (≥18 years of age) and (3) the study measured epigenetic clocks. The search will encompass literature and peer-reviewed literature in PubMed/MEDLINE (National Library of Medicine), Embase (Elsevier), Cochrane CENTRAL (Wiley & Sons), Web of Science: Core Collection (Clarivate Analytics), CINAHL (EBSCOhost) and PsycInfo (American Psychological Association).

Ethics and dissemination

Since the scoping review methodology focuses on published literature, this study does not require ethical approval. We will publish our findings in a peer-reviewed journal and plan to disseminate our work in conferences and scientific meetings.

Scoping review registration

Open Science Framework (https://doi.org/10.17605/OSF.IO/KW7RT).

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.

Assessing health system preparedness from trends and time delays in the management of myocardial infarctions during the COVID-19 pandemic in India: a multicentre retrospective cohort study

Por: Menon · J. C. · MS · A. · S · H. · Janakiram · C. · James · A. · Sreedevi · A. · Menon · G. R. · John · D. · Cherian · J. J. · V · V. · Abhaichand · R. K. · Punnoose · E. P. · BS · A. · Abraham · M. · Thomas · P. · Pedada · C. · Govindan · U. · Mohan · B. · Pisharody · S. · Devasia · T. · Seba
Objectives

This study aimed to analyse the number of myocardial infarction (MI) admissions during the COVID-19 lockdown periods of 2020 and 2021 (March 15th to June 15th) and compare them with corresponding pre-pandemic period in 2019. The study also evaluated changes in critical treatment intervals: onset to door (O2D), door to balloon (D2B) and door to needle (D2N) and assessed 30-day clinical outcomes. This study examined MI care trends in India during the COVID-19 lockdown period, irrespective of patients’ COVID-19 infection status.

Design

Multicentre retrospective cohort study

Setting

Twenty-three public and private hospitals across multiple Indian states, all with 24/7 interventional cardiology facilities.

Participants

All adults (>18 years) admitted with acute myocardial infarction between March 15 and June 15 in 2019 (pre-pandemic), 2020 (first lockdown) and 2021 (second lockdown). A total of 3614 cases were analysed after excluding duplicates and incomplete data.

Primary outcomes

Number of MI admissions, median O2D, D2B and D2N times.

Secondary outcomes

30-day outcomes including death, reinfarction and revascularisation.

Results

MI admissions dropped from 4470 in year 2019 to 2131 (2020) and 1483 (2021). The median O2D increased from 200 min (IQR 115–428) pre-COVID-19 to 390 min (IQR 165–796) in 2020 and 304 min (IQR 135–780) in 2021. The median D2B time reduced from 225 min (IQR 120–420) in 2019 to 100 min (IQR 53–510) in 2020 and 130 min (IQR 60–704) in 2021. Similarly, D2N time decreased from 240 min (IQR 120–840) to 35 min (IQR 25–69) and 45 min (IQR 24–75), respectively. The 30-day outcome of death, reinfarction and revascularisation was 4.25% in 2020 and 5.1% in 2021, comparable to 5.8% reported in the Acute Coronary Syndrome Quality Improvement in Kerala study.

Conclusion

Despite the expansion of catheterisation facilities across India, the country continues to fall short of achieving international benchmarks for optimal MI care.

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