Anaemia is highly prevalent among the indigenous population globally. Several interventions have been used to prevent and manage nutritional anaemia, including dietary measures, health education, oral iron supplements, food fortification and intravenous iron therapy. This protocol describes a systematic review and meta-analysis to assess the effectiveness of interventions for the prevention and treatment of nutritional anaemia in indigenous populations worldwide.
The review will include randomised controlled trials, quasi-experimental studies and observational studies evaluating interventions, including but not limited to iron and folic acid supplementation, dietary modifications, food fortification, deworming and health education. A robust search strategy will be developed, and six electronic bibliographic databases and Google Scholar will be searched from 2000 to 2025. Two reviewers will independently screen the identified studies, extract data, conduct a critical appraisal and evaluate quality using the Joanna Briggs Institute tool. Based on the level of heterogeneity, a meta-analysis will be conducted using either a fixed-effect or random-effects model, with pooled estimates, and 95% CIs. The I2 statistic will be used to evaluate heterogeneity. When meta-analysis is not feasible, narrative synthesis will be conducted. The impact of the intervention type and delivery model will be investigated using subgroup analysis.
This systematic review has been registered with PROSPERO. Ethical approval is not required as the study does not collect primary data from participants. The findings will be communicated via peer-reviewed journal articles and presentations at national and international conferences.
CRD420251120554.
This study aimed to understand hospital doctors’ priorities (target use cases and aetiologies) for the development of a new rapid diagnostic test for patients with fever.
A cross-sectional online survey.
Europe-wide.
Secondary and tertiary care doctors involved in patient assessment and diagnosis across Europe.
Online survey from April to September 2024.
Importance of developing a new test on a scale of 1–10 for up to 19 ‘use cases’ (types of febrile presentations in specific demographic groups): use case scores and ranks and differences across subgroups of respondents, with free text to capture additional suggestions; respondents’ preferences (multiple choice) regarding which aetiologies should be included in a new test.
265 respondents from 30 European countries (out of 270 starting the survey) were included in the analysis. Top priorities included febrile immunocompromised patients and fever without a focus for both paediatric and adult use cases, and 1–3 months old febrile infants. Rankings were similar across clinician subgroups despite some differences in average scores. 92% (243/263), 95% CI 89% to 95%, of respondents would find a ‘generic’ test for bacterial aetiology useful, even if it does not differentiate between Gram-positive and Gram-negative aetiologies. 54% (63/116), 95% CI 45% to 63%, of respondents would find a ‘generic’ test for inflammatory aetiology useful when seeking to diagnose children for whom Kawasaki’s disease (KD) is on the differential, even in the absence of any KD-specific test, 83% (96/116), 95% CI 75% to 89%, would find such a ‘generic’ test useful if they could use it alongside a KD test when desired.
Clinicians prioritise the most vulnerable patients (because of age or comorbidities) and unclear presentations (fever without a focus) for the development of a new fever diagnostic test. Even relatively simple (eg, bacterial, inflammatory) tests could provide added value to most clinicians.
Premature birth is the leading cause of neonatal morbidity and mortality. Understanding perceptions, beliefs and attitudes towards preterm births, and how these factors influence care provision at health facilities and at home is crucial for improving preterm newborns’ health outcomes.
We conducted an exploratory qualitative study at Batu and Meki communities in the East Shewa Zone of Oromia Region, Ethiopia. We conducted in-depth interviews (n=81) and focus group discussions (n=8) using semistructured guides. The study participants included women who had preterm births, family members, community members, healthcare workers and expert stakeholders. We audio-recorded, transcribed the interviews and coded the transcripts. We employed the socioecological model to present perceptions, beliefs and attitudes towards preterm birth at individual, interpersonal, organisational and societal levels.
Giving birth to a preterm newborn is often associated with fear, stress, unhappiness, concern and worry. At the individual level, preterm newborns’ mothers often feel guilt and self-blame. Families tend to keep preterm birth a secret due to perceptions of ‘incompleteness’. At the interpersonal level, preterm newborns are often stigmatised and families are disappointed by mothers who give birth prematurely. However, some believe that preterm newborns are accepted within the community. At the organisational level, healthcare providers find the causes of preterm birth unpredictable, they do not consider preterm births prevalent, and consider some of them as abortion. There is also a common belief that preterm infants have a low survival rate, leading to the deprioritisation of their care. At the societal level, some believe preterm births are caused by divine will as punishment for sins committed by the mother, while others think they occur naturally. Preterm newborn’s death is often not acknowledged as true loss and families are discouraged from grieving.
Our study found that the beliefs, perceptions and attitudes surrounding preterm birth, held by families, communities, healthcare providers and society at large, influence the care that preterm newborn–mother dyads receive both at home and within health facilities. Addressing these requires a multifaceted approach targeted at deeply ingrained attitudes and perceptions.
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.
Childhood cancer survivors (CCSs) experience educational disruptions during and following treatment, yet robust, longitudinal evidence on educational performance remains limited. We will investigate differences in educational outcomes between CCSs and non-cancer peers during primary and secondary school. We will also explore how sociodemographic factors and age at diagnosis contribute to potential differences in General Certificate of Secondary Education (GCSE) examinations, a critical indicator of future academic and employment prospects.
We will use the Education and Child Health Insights from Linked Data (ECHILD) to capture linked health and education data for children born in National Health Service (NHS)-funded hospitals in England. We will generate birth cohorts spanning September 1997 to August 2015 (estimated sample size: ~10 million), formed of pupils expected to have undertaken national curriculum assessments between academic years 2004/2005 and 2021/2022 including Key Stage (KS) 1, 2 and 4, corresponding to ages 7, 11 and 16 respectively. Cancer diagnosis will be identified from inpatient hospital records, using International Classification of Diseases, 10th Revision codes (ICD-10). We will investigate differences between CCS and their non-cancer peers in terms of their sociodemographic characteristics and describe trends in educational performances at all KSs, recorded Special Educational Needs and Disabilities (SEND) and school absences. Differences in KS4 (GCSE) performances between CCS and non-cancer peers will be quantified, according to and accounting for geographic region, sex, deprivation, ethnicity and birth characteristics. To assess whether cancer diagnosis disrupts academic trajectories, we will restrict analysis to those with KS2 attainment data and investigate KS4 performance. We will finally explore the influence of age at diagnosis on educational performance at KS4.
Ethics approval was granted by NHS Health Research Authority Research Ethics Committee (20/EE/0180). Findings will be shared with academics, policymakers, children and families affected by childhood cancer, and published in journals. Code/metadata will be shared on ECHILD GitHub repository.
Frailty is a key predictor of adverse surgical outcomes in older adults, contributing to increased postoperative complications, prolonged hospitalisation and delayed recovery. Prehabilitation—targeting improvements in physical function before surgery—can mitigate these risks. However, traditional programmes often face low adherence due to logistical barriers. Integrating smart wearable devices into tele-supervised, home-based prehabilitation may enhance adherence, engagement and clinical outcomes.
This trial protocol describes the PREhabilitation of frail elderly PAtients undergoing majoR surgEry at HOME study with the objective to evaluate the effectiveness of a wearable-enhanced, tele-supervised prehabilitation programme (swSEP) versus standard care (unsupervised prehabilitation, uSEP) on improving preoperative functional capacity and postoperative outcomes in frail older adults undergoing major elective surgery.
This single-centre, prospective, randomised controlled trial will enrol 190 patients aged ≥65 years scheduled for major elective, non-cardiac surgery at Singapore General Hospital. Participants with frailty (Edmonton Frail Scale ≥6) will be randomised 1:1 to either the swSEP group (tele-supervised exercise with Fitbit Inspire 3 monitoring) or the uSEP group (standard physiotherapy education, exercise booklet and inspiratory muscle training if maximal inspiratory pressure 2O). The primary outcome is change in 6 min walk test distance from baseline to 1–3 days presurgery. Secondary outcomes include 30 s sit-to-stand test, handgrip strength, postoperative complications (per American College of Surgeons National Surgical Quality Improvement Program), hospital length of stay, readmissions, five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) and adherence. Data will be analysed using t-tests, analysis of covariance, logistic regression and Cox models, with stratification by baseline nutritional status.
Approved by the SingHealth Institutional Review Board (CIRB Ref: 2024/2242). Trial registered on ClinicalTrials.gov (NCT06633614). Results will be disseminated via peer-reviewed publications and academic conferences. Contact: irb@singhealth.com.sg
ClinicalTrials.gov Identifier: NCT06633614
Patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA) are considered to have a symptomatic venous thromboembolism (VTE) risk of 1.0%–1.5% despite thromboprophylaxis. Fast-track treatment protocols have substantially lowered the VTE risk in most patients. Hence, the majority of patients may be unnecessarily exposed to the burden and risk of thromboprophylaxis. On the contrary, there are still patients with a high VTE risk who develop VTE despite thromboprophylaxis. Thus, tailored thromboprophylaxis treatment may potentially reduce both VTE and bleeding risk.
The DISTINCT (inDividual, targeted thrombosIS prophylaxis versus the standard ‘one-size-fits-all’ approach in patients undergoing Total hIp or total kNee replaCemenT) trial is a national, multicentre, randomised, multiarm, open-label trial. The main objective is to study whether tailored thromboprophylaxis reduces the occurrence of symptomatic VTE (primary outcome) and major bleeding (primary safety outcome) within 90 days after THA/TKA in comparison with standard thromboprophylaxis. Patients with a low, intermediate or high predicted VTE risk (based on the Thrombosis Risk Prediction following total hip and knee arthroplasty score (TRiP(plasty) score)) will be included in the DISTINCT-1, DISTINCT-2 or DISTINCT-3 studies, respectively. In the DISTINCT-1 trial, 3478 patients will be randomly allocated to receive either in-hospital thromboprophylaxis or standard prophylaxis. In the DISTINCT-2 cohort study, 2500 patients will receive standard prophylaxis. In the DISTINCT-3 trial, 4100 patients will be randomly allocated to receive either 6 weeks of high-dose thromboprophylaxis or standard prophylaxis. Standard prophylaxis consists of a low dose of any approved thromboprophylactic agent for 4 weeks. We hypothesise that (1) the efficacy of in-hospital only thromboprophylaxis is non-inferior in preventing VTE and equally safe compared with standard prophylaxis in patients with a low VTE risk (DISTINCT-1) and (2) prolonged high-dose thromboprophylaxis is superior in preventing VTE as compared with standard prophylaxis in patients with a high VTE risk (DISTINCT-3). Patients with intermediate VTE risk will be observed to evaluate VTE and bleeding rates (DISTINCT-2).
The protocol has been approved by the Medical Research Ethics Committee Leiden-Den Haag-Delft, EU-trial-number 2023-510186-98. Study results will be disseminated through peer-reviewed journals and during international conferences.
Patients living with chronic obstructive pulmonary disease (COPD) experience periods of disease stability and exacerbations (ECOPD). COPD imposes a negative and impactful extrapulmonary impairment and commonly overlaps with multimorbidity, particularly cardiovascular disease. Pulmonary rehabilitation (PR) aims to improve physical activity (PA) and quality of life, while behavioural change interventions (BCIs) aim to promote lifestyle changes and autonomy. However, after ECOPD, a variety of barriers often delay patient referral to PR. This study aims to assess the effects of a BCI for patients after ECOPD, focusing on cardiovascular health, PA and functionality. Additionally, the study will assess 6-month sustainability of PA and conduct a cost-utility analysis comparing a non-intervention group in the Unified Health System.
This randomised clinical trial will assess patients with ECOPD over 12 weeks using a BCI based on self-determination theory to increase daily steps. First, the cardiovascular and functional profile will be evaluated. Afterwards, the patients will receive an accelerometer to monitor the PA level. After 7 days, questionnaires will be applied on quality of life, symptoms and motivational levels for PA. Patients will be randomised into control group or intervention groups, both will receive educational booklets and IG will also receive an educational interview. PA will be tracked using activPAL accelerometer at weeks 1, 4 and 12, and follow-up at 6 months. Data analysis will include unpaired Student’s t-test or Mann-Whitney test for group comparison, and a linear mixed model to assess intervention effects over time. Economic evaluation, using STATA (V.14), will involve correlation analysis, and p
This study has been approved by the Federal University of São Carlos’ Ethics Committee, Irmandade Santa Casa de Misericórdia de São Carlos and Base Hospital of São José do Rio Preto. All procedures will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and applicable regulatory requirements. All results will be presented in peer-reviewed medical journals and international conferences.
Brazilian Registry of Clinical Trials under the registration number RBR-6m9pwb7.
The study was conducted to assess the diagnostic performance of the Hightop Syphilis Rapid Diagnostic Test (RDT) in comparison with the ELISA test used as a reference method.
A laboratory-based cross-sectional and comparative study was conducted to assess the diagnostic performance of the Hightop Syphilis RDT.
Blood samples obtained from adult participants in eight health facilities were analysed at the National Public Health Laboratory (NPHL), Ministry of Public Health, Yaounde, Cameroon.
From 29 April to 25 August 2023, 583 adult participants of both sexes (aged ≥21 years), including both syphilis positive and syphilis negative, were recruited consecutively in eight health facilities in eight regions of Cameroon.
Blood samples were screened for the detection of anti-Treponema pallidum antibodies using the One Step Rapid Test (Qingdao Hightop Biotech), a non-treponemal test and ELISA (Biorex Diagnostics, UK), a treponemal test used as a reference method. Diagnostic performance of the Syphilis RDT was analysed using Epi Info V.7 and validated through online statistical tools such as StatPages, GraphPad, QuickCalcs and MedCalc software.
Of the 583 samples tested, the Hightop Syphilis RDT revealed a sensitivity of 84.6% (95% CI: 74.8% to 91.1%) and specificity of 98.5% (95% CI: 97.5% to 99.1%). The positive predictive value (PPV) and negative predictive value (NPV) were 84.6% (95% CI: 74.8% to 91.1%) and 98.5% (95% CI: 97.5% to 99.1%), respectively. Regarding the stratification of diagnostic performance by clinical stage, the test showed a sensitivity of 100.0% (95% CI: 71.51% to 100.0%) and specificity of 99.06% (95% CI: 94.86% to 99.98%). The PPV and NPV were 91.67% (95% CI: 61.00% to 98.72%) and 100.0% (95% CI: 96.55% to 100.0%), respectively, in symptomatic individuals. Among asymptomatic individuals, sensitivity was 97.56% (95% CI: 87.14% to 99.94%) and specificity was 100.0% (95% CI: 99.14% to 100.0%). The PPV and NPV were 100.0% (95% CI: 91.19% to 100.0%) and 99.77% (95% CI: 98.40% to 99.97%), respectively.
The Hightop Syphilis RDT demonstrated adequate diagnostic performance, particularly among symptomatic individuals, supporting its utility as a reliable tool for syphilis detection in clinical settings.