Adolescents living with HIV (ALHIV) in sub-Saharan Africa (SSA) are a vulnerable population disproportionately affected by mental health disorders due to the combined burden of chronic illness, stigma and socioeconomic challenges. In response, numerous mental health interventions have been implemented to support ALHIV. However, the COVID-19 pandemic significantly disrupted health systems, particularly in-person services, potentially undermining the delivery and efficacy of these interventions. This protocol describes the methodology for a systematic review that will assess the impact of the COVID-19 pandemic on the implementation of mental health interventions for ALHIV in SSA and to explore the emergence or adaptation of interventions during this period.
Data will be collected, analysed and reported per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We will search PubMed, Web of Science, APA PsycINFO and Scopus for literature published from 2020 to 2025. Eligible studies will include both qualitative and quantitative designs that assess mental health interventions for ALHIV in SSA or explore pandemic-related implementation impacts. Both peer-reviewed and grey literature will be included. The primary outcomes of interest are implementation-related outcomes, including service disruptions, adaptations, feasibility, acceptability and barriers or facilitators influencing intervention delivery during the COVID-19 pandemic. Data, including study design, methodology and results, will be extracted and synthesised using an Excel spreadsheet. Specific inclusion and exclusion criteria will be used during literature screening and will include study type, location and language.
This review uses only publicly accessible data from previously published studies and does not involve the collection of primary data or identifiable human subjects. Therefore, ethical approval is not required. The results of the review will be disseminated through publication in a peer-reviewed journal and shared with stakeholders working in adolescent HIV and mental health services in SSA.
CRD420251147822.
Parents play a pivotal role in shaping their children’s food environment and eating behaviours. Involving parents in interventions designed to promote nutritional outcomes such as dietary intake in children has been shown to improve parental feeding practices. However, it remains unclear how such interventions influence children’s eating behaviour outcomes. This protocol describes the methods of a systematic review evaluating the effectiveness of interventions involving parents in improving the eating behaviours of healthy children aged 0–12 years.
Electronic databases including MEDLINE, EMBASE, CENTRAL, APA PsycINFO, CINAHL, Scopus and Web of Science will be searched from inception to September 2025. A search strategy is developed to identify randomised controlled trials directly involving parents and reporting eating behaviours in children as either primary or secondary outcomes. Two independent reviewers will screen identified records and extract data on study, participant and intervention characteristics. Study results relevant to our primary and secondary outcomes will also be extracted using a prepiloted standardised data extraction form. We will use the Revised Cochrane Risk of Bias tool (RoB2) and Grading of Recommendations Assessment, Development and Evaluation approach to assess risk of bias and certainty of evidence, respectively. Where possible, meta-analysis using random-effects models will be performed; otherwise a qualitative summary will be provided.
Ethics approval is not required for this study as no primary data will be collected. The findings will provide valuable insights for stakeholders to inform and optimise public health policies and practices aimed at empowering families to promote healthy eating behaviours early in childhood. The results will be submitted for publication in a peer-reviewed journal.
CRD420251076540.
Women of reproductive age (WRA) in low-income and middle-income countries (LMICs) bear a disproportionate burden of hypertension, with limited pooled analyses exploring its prevalence and associated risk factors. This study investigates hypertension prevalence and key determinants among WRA in 21 LMICs.
Retrospective, cross-sectional study.
Nationally representative data were obtained from the Demographic and Health Survey conducted in 21 LMICs between 2013 and 2023. This research focused on female participants aged 15–49 who were selected for blood pressure monitoring, resulting in a weighted sample of 818 325 WRA (36 970 pregnant and 781 355 non-pregnant).
The primary outcomes were the prevalence of hypertension (defined as systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) and the identification of individual, household and community-level risk factors associated with the condition. Descriptive statistics of proportions between pregnant and non-pregnant women were assessed. Multilevel logistic regression identified individual, household and community factors affecting hypertension.
The study found the prevalence of hypertension was 8.20% (95% CI 7.95% to 8.45%) among pregnant women and 10.52% (95% CI 10.42% to 10.62%) among non-pregnant women, with substantial regional disparities. Côte d’Ivoire and Haiti exhibited the highest prevalence (48.00% in pregnant women; 57.30% in non-pregnant women, respectively), while the Philippines reported the lowest (0.00% in pregnant women and 0.50% in non-pregnant women). Among pregnant versus non-pregnant women, risk factors included advanced age (35–49 years) (adjusted OR (aOR) 3.31, 95% CI 2.89 to 3.80 vs 3.69, 95% CI 3.60 to 3.77), low education levels (aOR 1.15, 95% CI 1.02 to 1.30 vs 1.33, 95% CI 1.30 to 1.35), not currently employed (aOR 1.08, 95% CI 1.01 to 1.15 vs 1.05, 95% CI 1.04 to 1.09), higher body mass index (BMI) (aOR 1.79, 95% CI 1.76 to 1.81; non-pregnant women), rural residence (aOR 1.14, 95% CI 1.04 to 1.24 vs 1.14, 95% CI 1.12 to 1.16) and limited healthcare access were linked to higher hypertension rates (aOR 1.03, 95% CI 0.94 to 1.13 vs 1.01, 95% CI 1.00 to 1.03).
The burden of hypertension among WRA is driven by advanced age, lower education, high BMI and rural residence. Policymakers should prioritise targeted interventions addressing key sociodemographic and geographic risk factors. Strengthening education, equitable healthcare access and community-based strategies is essential to reducing hypertension-related risks and associated maternal health complications among WRA in LMICs.
Chagas disease affects millions of individuals across Latin America and imposes a substantial economic burden on healthcare systems, particularly in rural and underserved regions. Chronic Chagasic cardiomyopathy remains one of the leading causes of heart failure-related mortality in endemic countries. Tissue inhibitor of metalloproteinases-1 (TIMP-1) has emerged as a potential biomarker of myocardial fibrosis in cardiomyopathies. This study was designed to investigate the association between TIMP-1 and myocardial fibrosis in chronic Chagas disease and to assess its potential as an early biomarker of fibrotic remodelling.
Bottom of form: The PTICH trial is a single-centre, prospective observational cohort study conducted at a government reference clinic in Pernambuco, Brazil. The study aims to enrol 210 adults with Chagas heart disease: 140 without ventricular dysfunction (left ventricular ejection fraction (LVEF) ≥52% in women and ≥54% in men) and 70 with ventricular dysfunction (LVEF
The Research Ethics Committee (REC) of Chagas disease and heart failure outpatient clinic—PROCAPE approved the PTICH trial (CAAE number: 65746322.8.1001.5192). Written informed consent has been obtained from all participants enrolled to date, and data handling is in compliance with applicable privacy and data protection regulations. Study findings will be disseminated through targeted outreach to civil society, the scientific community, healthcare professionals and Brazilian Unified Health System (SUS) policymakers; school-based science communication activities conducted in collaboration with state education departments (potentially including oral health educational materials); policy briefs and targeted reports for public health managers; technical meetings and institutional presentations; a plain-language summary published on the institutional website; and submissions to peer-reviewed journals and presentations at academic and health policy conferences.
RBR-3dcrj98.
Stakeholder involvement in research processes is widely recommended to enhance the relevance, quality and uptake of research findings. However, existing studies highlight persistent challenges in engaging family caregivers in co-design research. This gap may result in research outcomes that fail to reflect family caregivers’ needs and preferences, contradicting the core purpose of co-design. Therefore, the aim of this systematic review is to synthesise the available evidence on family caregivers’ experiences of involvement in co-design research and to generate evidence-based strategies to support effective engagement.
This systematic review will be conducted using a meta-aggregative approach, following the Joanna Briggs Institute’s (JBI’s) Manual for Evidence Synthesis. Systematic searches will be conducted in PubMed, CINAHL, Scopus, Web of Science and PsycINFO, with no date restrictions. Preliminary searches were performed in EMBASE between September and October 2025. Qualitative primary studies that explore family caregivers’ experiences of involvement in co-design research will be included. Study selection and quality appraisal will be performed independently by two researchers using predefined protocols, disagreements will be resolved through discussion with a third reviewer. After calibration, a single reviewer will extract the data using a customised data extraction template with the dataset distributed among the authors. The first author will then review all extractions. Data will be analysed following JBI’s meta-aggregative method, and results will be presented in narrative summaries, tables and diagrams. The findings will inform strategies for stakeholder involvement in future co-design research. Family caregivers and co-design researchers will be involved in reviewing and revising generated recommendations to enhance their relevance and practical utility.
This protocol does not involve human participants. The findings of this review will be submitted for publication in a peer-reviewed journal and presented at relevant scientific conferences and meetings.
CRD420251229190.
An alarmingly low number of children meet public health guidelines for physical activity and dietary behaviours and, therefore, are at increased risk of developing lifestyle-related diseases. This paper describes the protocol of the B-Challenged project, which aims to co-create systemic actions to promote active outdoor play and healthy dietary behaviours before, during or after their outdoor play together with children themselves.
In five European countries, child-centred Participatory Action Research (PAR)—combined with systems dynamics methods—was conducted with 15–20 child co-researchers (aged 9–12 years) and 15–20 adult actors (eg, youth workers, local policy makers). In the first phase, the main drivers of children’s active outdoor play and related dietary behaviours were mapped by (1) analysing existing cohort data, and (2) conducting child-centred PAR. In the second phase, systemic actions targeting the local physical and social environments will be co-created and implemented by child co-researchers and adult actors to promote children’s active outdoor play and related healthy dietary behaviours. A mixed-methods design will be used to evaluate (1) if actions positively contributed to systems change and 6- to 12-year-olds’ outdoor play and related dietary behaviours (140 children per country); (2) the process of conducting multi-actor, child-centred PAR and implementing the co-created actions and (3) if the child-centred PAR positively contributed to child co-researchers’ feelings of empowerment.
Ethics approval for the mapping phase was obtained and approval for implementation and evaluation will be obtained from the five local research institutions. Participating children, one of their parents/caregivers and adult actors had given informed consent before participating in the project. Throughout the project, child-friendly methods, materials and language will be applied, and ethical challenges and potential solutions will be discussed. Project results will be disseminated locally and internationally through various channels and activities among the scientific community, professionals—for example, in health and policy making, children and other citizens.
Sarcopenia is characterised by loss of muscle mass and strength. Although ageing is the most likely risk factor of sarcopenia, sarcopenia is prevalent even in non-elderly people. Type 2 diabetes (T2D) is a risk factor for sarcopenia, as T2D shares with sarcopenia several aetiological factors. Meanwhile, gestational diabetes mellitus (GDM) is characterised by metabolic alterations that resemble those observed in T2D, including increased insulin resistance (present even in physiologic pregnancies). Hence, GDM presents two major risk factors for sarcopenia, that is, dysglycaemia and insulin resistance. Moreover, the number of pregnancies at age >40 years is increasing, which is in an age range in which sarcopenia prevalence is already not negligible. However, data on the prevalence of sarcopenia prevalence in GDM and its effect on pregnancy outcomes are limited. Thus, this study aims to evaluate the prevalence of sarcopenia in women with GDM (and in pregnant women without GDM), identify risk factors and determine its effect on delivery and maternal and fetal outcomes.
For this study, 100 each of women with and without GDM will be recruited. Women will undergo an oral glucose tolerance test within weeks 24–28 for possible GDM diagnosis (in weeks 16–18 for high-risk women). Muscle/physical performance tests will be conducted at weeks 28–32 for possible diagnosis of sarcopenia/presarcopenia. Cognitive function will also be assessed. For all women, information regarding pregnancy progression, along with any complications, will be collected. Collected data will be analysed according to the main objectives of the study: (i) determine the prevalence of sarcopenia/presarcopenia in pregnancy with and without GDM, (ii) identify factors associated with sarcopenia risk, (iii) determine the effect of sarcopenia/presarcopenia on pregnancy outcomes, (iv) explore the relationship between sarcopenia and cognitive function. Therefore, this study will provide information on sarcopenia/presarcopenia prevalence in GDM and, possibly, in pregnancy not complicated by dysglycaemia. Furthermore, the study will provide knowledge on the main factors associated with sarcopenia/presarcopenia in GDM/pregnancy. The identification of such factors will be relevant for an initial guidance for treatments that may prevent sarcopenia in GDM/pregnant women. This will become of even greater interest if sarcopenia/presarcopenia influences pregnancy outcomes, especially in GDM women.
The study protocol has been approved by the Comitato Etico Regione Toscana - Area Vasta Nord Ovest (CEAVNO) on 25 July 2024 and by the Local Ethics Committee of the Medical University of Vienna on 17 June 2024. Participants’ enrolment began in May 2025. The results of the study will be presented at national and international conferences and in peer-reviewed journals.
ClinicalTrials.gov Identifier: NCT06876090; Registration Date: 2025-03-14
Patients in intensive care units (ICUs) and their families face existential physical, psychosocial and spiritual distress. Integrating palliative care (PC) into ICU care may benefit patients, relatives and ICU clinicians. Prior PC studies have shown a reduction in ICU length of stay (LOS) and distressing symptoms without altering overall mortality. A shorter ICU LOS may alleviate the burden for patients and relatives and help optimise the use of limited intensive care resources. PC in the ICU, however, remains underused, partly due to limited access and knowledge of ICU clinicians. Also, robust data regarding the effectiveness and cost-effectiveness of PC treatment in the ICU are scarce. We established the ‘enhancing palliative care in ICUs’ (EPIC) study to implement a system-based harmonised practice model across European ICUs. The aim is to investigate if early integration of PC via telemedicine, clinician education and bedside tools is effective and cost-effective, ultimately benefiting patients, relatives and ICU clinicians.
This multicentre, controlled, cluster-randomised, non-blinded stepped-wedge design trial with crossover phase aims to recruit around 2,000 patients from five European countries. All adult patients admitted to participating ICUs—with an ICU LOS exceeding 72 hours, where cancer is not the primary cause of critical illness, and who are not expected to die within the next 24 hours—are screened for the need for specialised PC based on the attending physician’s judgement. This judgement is triggered by the presence of one or more of the following: (1) significant disagreement among ICU team members and/or relatives about the appropriateness of current ICU treatment, (2) considerations of limiting life-sustaining therapy or (3) the anticipation that a specialised PC consultation may benefit the patient, their relatives or the ICU team. Patients identified as needing specialised PC and their relatives are then enrolled after obtaining written informed consent.
The complex intervention consists of (a) a blended-learning programme to foster knowledge and attitude about PC among ICU clinicians, (b) bedside tools, including a checklist to identify patients in need of PC and a factsheet and (c) standardised telemedical consultations from trained EPIC interventionists. Patient and relative follow-up is conducted 3 months post-ICU discharge. Outcomes include clinical measures (including ICU LOS (primary outcome), severity of critical illness, invasive treatments and health-related quality of life), economic endpoints (resource use, costs, cost–consequence situation, cost-effectiveness), ICU clinician burnout and distress, and patient and family perception about the quality of symptom management, care and communication. Endpoint analyses will employ generalised linear mixed models, accounting for the clustered data structure and stepped wedge design.
EPIC complies with the Declaration of Helsinki and has been approved by all local ethics committees. A decision-making structure is established to ensure trial procedures are carried out according to Good Clinical Practice. Study findings will be published in peer-reviewed journals and communicated to participants, healthcare professionals and the public. Sets of anonymised study data will be made available following Findable, Accessible, Interoperable, and Reusable principles.
We conducted a feasibility study to evaluate the feasibility of recruiting patients to examine the effect of near vision glasses in young infants at risk of cerebral visual impairment.
A three-arm, parallel-group, open-label randomised feasibility trial.
Tertiary neonatal intensive care in London, UK.
We included babies born before 29 weeks of gestation or at full term with hypoxic ischaemic encephalopathy. Babies who needed ongoing inpatient care, with established eye anomalies or with very high refractive errors at baseline (±8.00D) were not included. Infants with retinopathy of prematurity were not excluded.
At 8 weeks corrected age, we allocated 18 infants to wear glasses (+3.00D over full cycloplegic refraction) immediately (intervention 1), 18 to wear the same glasses at 16 weeks (intervention 2) and 19 infants were allocated to standard treatment (no glasses).
Recruitment and retention of study participants (primary), compliance wearing glasses, preferential-looking visual acuity (with glasses) and visual function as determined using A Test Battery of Child Development for Examining Functional Vision at 3-month and 6-month age post-term.
Of 70 eligible families, 55 consented and 34 attended baseline assessments, and 28 completed the study. Non-attendance was due mainly to prolonged inpatient stay, infant health and scheduling conflicts. Glasses were worn for similar periods in each group (Intervention 1: median 2 hours/day (95% CI 1 hour to 4 hours); Intervention 2: median 2 hours/day (95% CI 1.5 hours to 3 hours)). Visual acuity improved from baseline to 6 months. Mean (SE) LogMAR (Minimum Angle of Resolution) improvements were standard care: 0.47 (0.45); intervention 1: 0.66 (0.44); intervention 2: 0.37 (0.36). Among the 29 very preterm infants, there were similar findings: standard care: 0.35 (0.35); Intervention 1: 0.67 (0.47); Intervention 2: 0.34 (0.40). As a functional measure, object permanence was present at the following rates by randomised arm: standard care: 29%; whereas intervention 1: 56%; and intervention 2: 44% (OR intervention 1 vs standard care: 3.13 (95% CI 0.38 to 25.57), ie, not statistically significant).
We demonstrate feasibility for a definitive RCT (randomized controlled trial) with good recruitment and retention and observed potential benefits for vision and development following the dispensing of glasses at 8 weeks post-term age compared with untreated controls. We identified methodological modifications to further improve recruitment processes for a future larger study.
We investigated symptoms reported before and after heart failure (HF) diagnosis and their associations with 3-month hospitalisation and mortality.
To examine associations between symptoms recorded in primary care and short-term hospitalisation and mortality in HF patients.
Landmark analysis using Royston-Parmar survival models at baseline (diagnosis), 6 and 12 months post-diagnosis.
Primary care database (Clinical Practice Research Datalink) linked to hospital and mortality data (1998–2020).
Adults (>40 years) with a first HF diagnosis.
Shortness of breath, ankle swelling, oedema, fatigue, chest pain, depression and anxiety in the 3 months before diagnosis and at 6 and 12 months.
3-month all-cause hospitalisation and mortality; secondary outcomes included HF and non-cardiovascular hospitalisation.
Among 86 882 HF patients (62 742 and 54 555 surviving to 6 and 12 months, respectively), the magnitude of symptom risk varied by timepoint. Specifically, the symptoms with the strongest associations with adverse outcomes were: depression for all-cause hospitalisation at diagnosis (HR: 1.26; 95% CI 1.15 to 1.39) and 6 months (1.46; 1.25 to 1.70); ankle swelling for mortality (1.49; 1.14 to 1.94) at 6 months and SOB for HF hospitalisation (1.18; 1.12 to 1.26) at diagnosis and 12 months (1.99; 1.68 to 2.35).
Symptoms persisted and were more prominent at 6 and 12 months post-diagnosis than at diagnosis.
Poverty can have profound negative impacts on parent, child and family health. Primary care providers are in a unique position to address child poverty. Some team-based models have integrated community support workers (CSWs) for social service system navigation assistance. The overall aim of this study is to rigorously test a poverty reduction intervention (navigation of financial supports) embedded in primary care. The primary objective is to compare parenting stress between CSW-supported, structured review of financial supports and social system navigation (intervention) and receipt of written summary of local resources (usual care).
This is a multisite pragmatic superiority randomised controlled trial with a 1:1 allocation to the CSW-supported social system navigation versus no navigation. Parent–child dyads (80 parents of children aged Do you ever have difficulty making ends meet at the end of the month?’) will be recruited during a scheduled health supervision visit from primary care practices in Kingston, Ontario. Intervention group participants will have a structured review of financial supports with a trained CSW and will meet up to 6 times over 6 months. Outcomes are measured at baseline, 6 months and 12 months after randomisation. The primary outcome is the Parenting Stress Index Fourth Edition Short Form (PSI-4-SF) total score at 6 months. Secondary outcomes include household income, food insecurity, parent mental health (depression and anxiety) and child health. An internal pilot study was used to obtain more reliable estimates of the SD of PSI-4-SF at 6 months to recalculate the sample size (if needed) and assess randomisation and completion rates. Qualitative interviews conducted 9 months after enrolment explore parent experiences with the CSW intervention.
Research ethics approval by Queen’s University Health Sciences REB. Results will be shared with the College of Family Physicians of Canada, the Ontario SPOR SUPPORT Unit and academic forums.
Connecting Families (Registered 12 October 2021 at www.clinicaltrials.gov;
Nigeria has the highest number of maternal deaths globally, and maternal peripartum sepsis is one of the leading causes of maternal mortality. A single oral dose of azithromycin (AZM; 2 g) is safe and effectively reduces 33%–60% of maternal sepsis during planned vaginal birth in low- and middle-income countries (LMICs). However, the clinical and cost-effectiveness of oral AZM during vaginal birth in Nigeria remains unknown in the context of poor antimicrobial stewardship practices, significant antimicrobial resistance and healthcare financing. Evidence is also lacking on the standard care for the prevention of maternal sepsis among pregnant women undergoing vaginal births in Nigeria. The AZIN-V trial is a hybrid type 2 effectiveness-implementation trial to determine the safety, clinical and cost-effectiveness of intrapartum oral AZM versus usual care in the prevention of peripartum maternal sepsis. The trial will also examine the impact of implementation strategies in enhancing adherence to the oral AZM protocol during planned vaginal births and identify effective strategies to improve adherence (fidelity) to the protocol in real-world LMIC settings.
This is a multicentre hybrid type 2 trial conducted in six Nigerian states: Ebonyi, Edo, Gombe, Kano, Kwara and Lagos. The study aims to simultaneously test the clinical and cost-effectiveness of AZM (clinical trial) and the impact of implementation strategies (implementation research) in Nigeria’s unique healthcare context. The clinical trial is a two-arm, cluster-randomised controlled trial conducted across 48 health facilities, randomly assigned (1:1) to either intrapartum administration of oral AZM (intervention group) or usual care—the current routine practice (control group). A total of 5040 study participants (2520 in each group) will be enrolled in the clinical trial. The implementation trial is a two-arm cluster non-randomised controlled trial conducted in 12 health facilities (1:1) allocated to either a bottom-up approach using the Plan-Do-Study-Act cycle or a usual top-down approach with a one-time training workshop and distribution of clinical guidelines, with both arms administering oral AZM during vaginal birth while assessing fidelity (primary outcome).
For the clinical trial, data will be analysed using intention-to-treat statistical methods. The cost-effectiveness outcome will be analysed using the Incremental Cost-Effectiveness Ratio. Implementation outcomes will be analysed using descriptive statistics and a thematic approach.
This study has been approved by the National Health Research Ethics Committee, Nigeria (NHREC/01/01/2007-30/09/2024), the ethics committees of the participating health institutions (Lagos University Teaching Hospital Research Ethics Committee: ADM/DSCST/HREC/APP/6325; University of Ilorin Teaching Hospital Health Research Ethics Committee: ERC/PAN/2025/03/0581; University of Benin Teaching Hospital Health Research Ethics Committee: ADM/E22/A/VOL. VII/483117141; Aminu Kano Teaching Hospital Research Ethics Committee: AKTH/MAC/SUB/12 A/P-3/VI/2509 and Irrua Specialist Teaching Hospital Research Ethics Committee: ISTH/HREC/20241507/605), the Ministries of Health of the six states and the National Agency for Food and Drug Administration and Control. Written informed consent will be obtained from all eligible study participants before enrolment. Results will be shared with communities and policy stakeholders and through peer-reviewed journals and will be presented at conferences.
There is a high level of older people neglect in Nigeria, especially in the rural setting, and they did not receive much attention in terms of their overall health and well-being. Government social interventions are usually geared towards the children, adolescents, pregnant women and lactating mothers. Evaluating the level of functional decline and social support among these groups and how it affects their overall well-being will enable policy formulations geared towards holistic care for them. This study aimed to determine the level of functional dependence in some basic activities of daily living (ADLs: mobility, dressing, grasp and bathing) and social support in older people to enhance evidence-based advocacy to all stakeholders in older people care.
This was a hospital-based cross-sectional study of 160 (75 males and 85 females) older people aged 65–98 years selected through systematic random sampling. The 2 test, t-test and logistic regression were used for analysis.
The response rate was 100%. The mean age of male respondents was 76.31±8.34 years and that of the female respondents was 76.87±7.47 years. A statistically significant association was found between age >75 years, absence of a spouse, low education level and functional dependence in all ADLs studied. Although age independently predicted dependence in all studied ADLs, except dressing and grasp, marital status predicted dependence in dressing and bathing, and availability of care also predicted dependence in mobility.
Age is an independent risk factor for functional dependence in mobility and bathing, and marital status independently predicted dependence in dressing and bathing. Not receiving care also independently predicted dependence in mobility. Thus, improvements in the biopsychosocial, biomedical and economic well-being of older people will ameliorate the impact of poor care on functional status and ADLs.
The real-world evidence on the association between vitamin D supplementation and cognitive outcomes has been scant and controversial. We aimed to investigate the longitudinal association between vitamin D supplement use and subsequent cognitive functioning among US older adults.
Prospective cohort study.
A nationally representative ageing cohort in USA: the Health and Retirement Study (HRS).
Participants were drawn from the HRS wave 12 and included respondents who had complete data on dietary supplement use and cognitive assessment. A total of 5065 participants (mean age: 67.5±10.2 years, 61.6% female, 76.6% White ethnicity) were included, of whom 2004 (39.6%) participants were vitamin D supplement users.
Change in cognitive function scores over 6 years of follow-up (from HRS waves 12–15), estimated by linear mixed model adjusted for multiple covariates.
Compared with non-users, vitamin D users had an accelerated decline in global cognitive function (difference in the rate of change: –0.052 points/year; 95% CI –0.092 to –0.013, p=0.010) and in executive function score (difference: –0.021 points/year; 95% CI –0.037 to –0.005, p=0.010). Sensitivity analysis suggested that accelerated cognitive decline was only observed among supplement users with normal baseline serum 25(OH)D level (p=0.004), but not the group with insufficient/deficient levels (p=0.826).
Our findings do not support vitamin D supplementation as a means of preventing or slowing cognitive decline in older people with adequate vitamin D status. While healthcare providers should encourage adequate vitamin D intake from dietary sources and moderate sun exposure, caution should be taken when recommending such supplements to older adults without a clear indication for it.
Chronic respiratory diseases (CRDs), such as asthma and chronic obstructive pulmonary disease (COPD), are among the leading non-communicable diseases (NCDs) worldwide. However, diagnosing CRDs in low-income and middle-income countries (LMICs) remains challenging due to limited access to spirometry and trained professionals. Aggravating the burden, CRDs often coexist with other NCDs, increasing healthcare costs, reducing quality of life and elevating mortality. These challenges highlight the need for simple case-finding approaches for CRDs, such as the COPD in Low-Income and Middle-Income Countries Assessment (COLA-6) questionnaire, to support prompt identification and appropriate care within NCD services in LMICs.
To evaluate the discriminative accuracy, feasibility and implementation of the COLA-6 questionnaire in identifying and managing CRDs in Brazilian Primary Healthcare (PHC) services for NCDs.
The Multimorbidity Approach for REspiratory Solutions (MARES) study consists of three work packages to be conducted in PHC services in São Carlos/SP and São Paulo/SP, Brazil.
MARES-1: A cross-sectional observational study enrolling 859 individuals with at least one NCD receiving care in PHC. The COLA-6 questionnaire will be administered by the research team and compared with quality-assured spirometry. The Chronic Airways Assessment Test (CAAT), Asthma Control Questionnaire (ACQ-7) and fractional exhaled nitric oxide (FeNO) will also be assessed. The diagnostic performance of COLA-6 for identifying CRDs—including COPD, asthma, preserved ratio impaired spirometry, restriction and overlaps—will be assessed using area under receiver operating characteristic curves and 95% CIs.
MARES-2: A cross-sectional observational study enrolling 20 healthcare professionals (physicians, physiotherapists, community health agents and nurses) from five PHC services. These professionals will apply the COLA-6 during routine NCD care to a total sample of 1000 patients. Qualitative interviews will be conducted to explore barriers and facilitators to the implementation of COLA-6, using deductive thematic analysis.
MARES-3: A longitudinal, prospective observational study in which patients from MARES-1 and MARES-2 will be reassessed at 6-month follow-up. A total sample of 473 participants with abnormal spirometry, a diagnosis of CRD or high risk for CRDs is expected. Participants will undergo spirometry, and a subset will be interviewed to explore their healthcare experiences through qualitative thematic analysis. Access to diagnostic and treatment services in Brazil will be assessed. Changes in spirometry values, FeNO, CAAT and ACQ-7 scores from baseline to 6 months in patients from MARES-1 will be analysed.
This study has been approved by the Ethics Committees of Federal University of São Carlos and University of Santo Amaro (UNISA). Ethical approval was also granted by the University College London. Results will be disseminated through peer-reviewed medical journals and presentations at international conferences. Results will improve identification of CRDs, addressing a significant gap in current PHC settings.
This scoping review aims to map evidence or literature on improvement strategies used by health leaders and professionals to strengthen the safety climate in the operating room.
A scoping review was performed on the basis of the method proposed by the Joanna Briggs Institute and applied to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews (PRISMA-ScR) extension.
16 academic and grey literature data sources were searched using search terms on 17 January 2025, namely, Medical Literature Analysis and Retrieval System Online via Pubmed, Latin American and Caribbean Literature on Health Sciences via the Virtual Health Library, Cumulative Index to Nursing and Allied Health Literature, Scopus, Web of Science, Embase, PsycINFO, Cochrane Library, WorldCat, Digital Library of Theses and Dissertations, Brazilian Association of Surgical Center Nurses, Center for Material and Sterilization and Anesthetic Recovery, Association of Portuguese Operating Room Nurses, Association of PeriOperative Registered Nurses, Institute for Healthcare Improvement, WHO and Agency for Healthcare Research and Quality.
Study selection, data extraction and synthesis were based on the following eligibility criteria based on the acronym PCC (participants, concept, context): participants (health leaders and professionals), concept (strategies to improve the safety climate) and context (operating room). This scoping review considered studies published from 2009 onwards.
Information on the objective, method and findings addressing improvement strategies employed to strengthen the safety climate in the surgical centre was retrieved. The findings are presented in tables and in a qualitative thematic summary.
A total of 26 studies were analysed, published between 2009 and 2024, with the USA as the country of origin of the publications with the highest number (11 studies). As for the methodological approach, intervention and quasi-experimental studies stand out. When the studies in this review were mapped, strategies that strengthened the safety climate in the operating room were identified and grouped into two main axes that are interrelated: communication tools and training programmes.
It is evident that the implementation of tools that promote communication and training programmes enhances safe surgical care, as they contribute substantially to the domains of the safety culture. The use of communication protocols in the operating room is recommended as a perioperative safety tool.
This scoping review adhered to a protocol previously published in this journal and that is registered on the Open Science Framework website (https://osf.io/zg8nu/).
Despite evidence of the cost-effectiveness of physical activity (PA) promotion interventions in healthcare settings, translating them into practice remains challenging. This study aimed to identify implementation barriers and facilitators of a Portuguese PA consultation programme implemented in primary healthcare of the Portuguese National Health Service. Additionally, it sought to inform future implementation strategies, using a theoretically based approach.
Qualitative interview study, using both deductive and inductive approaches.
Primary healthcare units across all health administration regions of mainland Portugal.
Twenty-eight participants (six medical doctors, five exercise professionals and 17 patients) from all health regions of the country, involved in the implementation of the Portuguese PA prescription consultation.
Fifty-three categories of determinants were identified, using the Tailored Implementation for Chronic Diseases framework. Key barriers included ineffective referral processes to the consultation, challenges in integrating the intervention with existing healthcare demands and insufficient local/regional prioritisation of PA promotion. Key facilitators included high intervention acceptability, diverse community PA resources and good interpersonal skills of implementers. Drawing on the Behaviour Change Wheel, theoretically based inputs to design strategies addressing each barrier were provided.
The implementation of PA consultation was influenced by a broad range of determinants. The most frequently reported barriers are primarily structural and opportunity-related, suggesting system-level implementation strategies are most appropriate. Future strategies should consider implementing clinical standards/orientations for PA promotion, providing institutional incentives based on the attainment of PA indicators, expanding consultation coverage and diversifying referral strategies, reinforcing health system-community partnerships and strengthening training opportunities for implementers. These findings offer relevant insights for enhancing the future implementation of PA consultations, for scaling them up and, ultimately, to increase their effectiveness.
The study aims to present recommendations for a revised Doctor of Pharmacy (Pharm-D) curriculum that aligns with regional needs and international standards of pharmacy education.
An exploratory qualitative study involving individual semistructured interviews. Data were collected and reported in accordance with Consolidated Criteria for Reporting of Qualitative Studies.
Face-to-face interviews were conducted in the respective offices of the experts and online interviews were conducted on Zoom and Google Meet.
Purposive and snowball sampling was used to recruit experts due to the eligibility criteria of including associate professors with a PhD, and snowball sampling facilitated the recruitment of experts from all provinces and internationally. Interviews were transcribed verbatim and data were analysed using an inductive thematic approach using NVivo V.15. All interviews were conducted in English.
The study engaged 49 experts from national and international settings with an age range of 25–60 years (median=43 years). The researchers came out with six themes and their subthemes from the data including: (a) understanding current Pharm-D curriculum in Pakistan, (b) inevitable changes required in the Pharm-D curriculum, (c) specific-subject based changes, (d) foundational steps to achieve the required changes, (e) barriers to the implementation of these changes and (f) impact of Pharm-D curriculum change.
The findings highlighted a clear need to revise the curriculum by incorporating enhanced clinical pharmacy content, integrated learning approaches, elective courses, interprofessional education, mandatory hospital and clinical placements, experiential learning through simulation-based methods and research components through a collaborative approach from policy makers and academic stakeholders.
The 2013–2016 Western African outbreak of the Ebola virus disease (EVD), the largest recorded outbreak since the discovery of Ebola virus (EBOV) in 1976, destabilised local health systems and left thousands of survivors at risk for postacute sequelae, including vision-threatening uveitis. In an EVD survivor with severe panuveitis, the detection of persistent EBOV in the aqueous humour, long after clearance of acute viremia, focused clinical and research attention on the host-EBOV interaction in the unique terrain of ocular immune privilege. Despite the recognition that uveitis is common and consequential in EVD survivors, our understanding of pathogenesis is extremely limited, including the contributions of viral persistence and ocular-specific and systemic immune responses to disease expression. In this study protocol, we outline a multifaceted approach to characterise EVD-associated intraocular inflammation, including the clinical phenotype and complications; the presence of EBOV (or EBOV RNA/antigen) in ocular fluids and tissues; and associated local ocular-specific and peripheral immune responses.
We use an observational cohort design, which includes EVD survivors and close contacts of EVD survivors (ie, no documented history of EVD), and we propose disease (clinical examination and imaging), as well as molecular, virologic and immunologic characterisation, to meet research objectives.
This study has received Institutional Review Board approval from University of Nebraska Medical Centre, Emory University and Sierra Leone Ministry of Health. Findings will be disseminated through peer-reviewed publications.
To investigate vaccination coverage for influenza and COVID-19 in the SARS-CoV-2 immunity and reinfection evaluation (SIREN) study cohort of healthcare workers (HCWs) between 2020 and 2023 and explore vaccination enablers and barriers.
A mixed-methods study nested within SIREN, a multicentre prospective cohort study of HCWs across the UK. Quantitative and qualitative methods were used sequentially, using an expansion/explanation function, enabling emergent themes observed from the quantitative stage to be explored in the qualitative stage.
SIREN sites include secondary care centres and community mental health trusts in the UK.
Quantitative analysis was conducted on data from 6048 participants. Participants were representative of the HCW workforce, with the majority being women (83%) and of white ethnicity (88%). Nurses made up the largest occupational group (33%). Qualitative analysis of data from 24 participants including five focus groups (n=21) and three semistructured interviews (n=3); 82% women, 26% minority ethnic, all working age from across the UK.
Quantitative: vaccine coverage for COVID-19 and influenza vaccines by demographic with multivariable logistical regression used to assess differences. Qualitative: thematic analysis to explore reasons behind the results seen in the quantitative stage.
COVID-19 vaccination was initially high; 97% received two doses and 94% a first booster. However, coverage was reduced to 77%, for the second booster. Influenza vaccination coverage was lowest in 2020–2021 (46%), increasing to 73% in 2021–2022 and to 79% in 2022–2023. In 2022–2023, vaccination coverage was higher for influenza than for COVID-19. High vaccine coverage for both COVID-19 and influenza was observed in doctors, pharmacists and therapists. Porters, healthcare assistants and staff from minority ethnic groups had lower vaccine coverage for both COVID-19 and influenza. Four themes were identified: (1) attitudes towards vaccination changed throughout the COVID-19 pandemic; (2) HCWs used data to inform vaccination decisions; (3) poor communication in healthcare settings contributed to a reduction in vaccination; (4) there were both positive and negative impacts of the COVID-19 vaccine on influenza vaccine uptake and other vaccination programmes.
Between 2020 and 2023 in our cohort, COVID-19 vaccination coverage decreased, whereas influenza increased. Our study found attitudes to both vaccines have shifted, becoming more favourable to influenza and less to COVID-19 boosters. Barriers to COVID-19 boosters, including concerns about side effects and vaccine effectiveness, need to be addressed with improved communication on the benefits and adverse events. Future vaccination strategies should address the differences we have identified in vaccine coverage across demographics and occupational groups, including continued efforts to improve vaccine equity.