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Tuberculosis death prediction calculator for prospective use at diagnosis in resource-constrained programme settings: a statewide cohort study

Por: Shanmugasundaram · S. · Shewade · H. D. · Srinivasan · R. · Frederick · A. · Sabarinathan · R. · Harish · P. · Balu · D. · Melfha · J. M. · Gayathri · K. · Vijayaprabha · R. · Jeyakumar · A. · Kabir · D. · Eraivan · M. · Bhatnagar · T. · Murhekar · M. V.
Objectives

To develop predictive models for early and overall tuberculosis (TB) deaths for prospective use at TB diagnosis in resource-constrained TB programme settings.

Design

Statewide cohort study using routinely captured secondary data.

Setting

With the majority of TB deaths being early (within 2 months), India’s TB programme’s information management system (Ni-kshay)-dependent death prediction models (using age, gender, TB site, previous treatment, microbiological confirmation, HIV, diabetes and bank account availability) are not feasible for prospective use, as few variables are captured at diagnosis. Utilising routinely captured triage variables for severe illness at diagnosis (body mass index, pedal oedema, respiratory rate, oxygen saturation and ability to stand without support) from an ongoing statewide and state-specific differentiated TB care initiative to reduce TB deaths in Tamil Nadu state (southern India, 80 million population with 0.1 million annual notifications), robust models for prospective use were developed.

Participants

Adults (aged ≥15 years) with TB (not known to be drug-resistant at diagnosis) that were notified from public facilities of Tamil Nadu from July 2022 to June 2023.

Outcome measures

Early and overall (within 12 months of notification) TB deaths. Area under the receiver operating characteristic curve (AUC) was used to assess accuracy of models built using modified Poisson regression.

Results

Among 55 971 adults, the overall death rate was 7.4%, and 67.9% of the deaths were early. In predicting overall deaths, accuracy of the model using all Ni-kshay variables (AUC 0.716 (95% CI 0.707 to 0.725)) was as good as the model using triage variables for severe illness only (AUC 0.701 (95% CI 0.691 to 0.711)). To the latter, adding potentially capturable Ni-kshay variables at diagnosis (age, gender, TB site, previous treatment and microbiological confirmation) significantly improved model accuracy (AUC 0.754 (95% CI 0.745 to 0.763)). Further addition of remaining Ni-kshay variables did not improve accuracy significantly. Death prediction equations were generated for these models.

Conclusion

Simple and easily measurable triage variables for severe illness should be routinely captured at TB diagnosis. A death prediction calculator (http://44.208.93.99/) based on these variables (specifically triage variables for severe illness combined with age, gender, TB site, previous treatment and microbiological confirmation) may be used by Indian states and high TB burden countries seeking scalable, data-driven interventions to reduce TB deaths.

Perspectives and challenges in implementing nursing-specific mini-CEX and DOPS: a descriptive qualitative study of clinical nursing educators and novice nurses in a tertiary hospital in China

Por: Nie · S. · Ma · S. · Wang · L.
Objectives

This study aimed to explore the dual perspectives and challenges of clinical nursing educators and novice nurses regarding the implementation of nursing-specific mini-clinical evaluation exercise (mini-CEX) and direct observation of procedural skills (DOPS) in novice nurses’ training within a single tertiary hospital in China.

Design

A descriptive qualitative research design was used. Participants were selected using a purposive sampling method, and semistructured interviews were conducted to collect data, which were then analysed following the six-step thematic analysis process.

Setting

The study was conducted at a tertiary hospital in Beijing, China.

Participants

A total of 24 participants were recruited from November to December 2023, comprising 13 clinical nursing educators and 11 novice nurses.

Results

Four themes emerged: (1) novice nurse growth: true reflection of novice nurses’ clinical nursing abilities through direct observation; tailored learning pathways for individual growth; immediate feedback and self-reflection-driven engagement for individualised learning advancement; visual analytics for identifying targeted improvement areas and tracking progress across clinical domains; (2) educator teaching quality: practical contents and flexible methods of evaluation; real-time teaching adaptation and refined teaching plans; educator-led multidimensional nursing competencies cultivation; (3) obstacles in implementing evaluation tools: time-consuming processes in assessment and manual documentation; insufficient and delayed feedback due to heavy clinical workload; interruption of implementation by significantly changed clinical situation and (4) factors affecting implementation efficacy: subjective differences in scoring and inconsistent evaluation standards; lack of specialty in assessment tools; teaching-related factors; novice nurses’ personal factors; patient-related factors; feedback-related factors.

Conclusions

Educators and novice nurses perceived that the nursing-specific mini-CEX and DOPS have many advantages but raise concerns about time-consuming assessments, inadequate or delayed feedback, disruptions to implementation due to significant clinical changes, inconsistent standards and a lack of specialised assessment tools as well as multiple factors affecting its efficacy. Future research should focus on efficient strategies for optimal use.

Loneliness and social isolation at the emergency department: a scoping review protocol

Por: Chan · W. L. · Gao · Z. · Chuxi · A. L. · Rainer · T. · Tang · W. W. C. · Wing · Y. S. S. · Lederman · Z.
Introduction

Loneliness and social isolation are critical public health issues linked to significant adverse health outcomes and increased healthcare utilisation, including visits to the emergency department (ED). The ED often serves as a primary societal safety net, providing care for vulnerable populations who may be disproportionately affected by these conditions. In fact, loneliness and social isolation might be the underlying reasons they presented to the ED in the first place either consciously or not. For such individuals, the ED encounter may represent a rare point of human contact, yet the stressful and depersonalising nature of the ED environment may paradoxically exacerbate their sense of isolation. Furthermore, ED staff may lack the training and awareness of the scope of the problem to properly screen for loneliness and address it. Yet, the compounded impact of the ED experience on lonely or socially isolated patients and the relationship between loneliness and healthcare utilisation remains poorly understood. This paper presents a protocol for a scoping review designed to systematically map the existing evidence on the experiences of these patients and the perspectives of the clinicians who care for them.

Methods and analysis

This scoping review will be conducted following the Arksey and O’Malley methodological framework in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). The findings will be reported according to the Extension to the PRISMA Statement for Reporting Literature Searches in Systematic Reviews (PRISMA-S; see ). A comprehensive search will be performed across five electronic databases (PubMed, Embase, Scopus, Web of Science, CNKI) and grey literature sources. Studies published in English or Chinese that address loneliness or social isolation in the ED context, from the perspective of adult or paediatric patients or clinical staff, will be included. A novel, artificial intelligence (AI)-assisted screening process will be utilised for initial relevance assessment, followed by full manual screening and data extraction by two independent reviewers to ensure rigour and mitigate bias. Findings will be synthesised using a narrative approach and thematic analysis to identify key concepts, themes and existing gaps in the literature.

Ethics and dissemination

As this study synthesises data from previously published literature, it does not require formal ethical approval. The findings will be disseminated through a manuscript submitted to a peer-reviewed, open-access journal. The aim is to provide an evidence-based roadmap to guide future research, inform policy and support the development of interventions designed to improve care and outcomes for this vulnerable population within the acute care setting.

Registration number

The review has been registered at Open Science Framework, DOI 10.17605/OSF.IO/MBVSR.

Perceptions of healthcare professionals and community members on acute febrile illness management in Maputo and Quelimane City: a qualitative study

Por: Monteiro · V. D. C. O. · Nhassengo · P. · Muamine · E. · Alho · P. · Manganhe · Y. · Zandamela · A. · Cambe · M. I. · Gudo · E. S. · Craveiro · I.
Introduction

Acute febrile illness is a major cause of morbidity and healthcare seeking in sub-Saharan Africa, including Mozambique. However, few studies have explored the perceptions and practices related to clinical management of acute febrile illness. Our aim was to understand the perceptions, knowledge and practices of healthcare professionals and community members regarding the management of acute febrile illness.

Methods

A qualitative study was conducted using a thematic analysis approach. Eight focus group discussions (FGDs) and three in-depth interviews (IDIs) were conducted in two Mozambican provinces across four healthcare facilities. Purposive sampling was used to select participants, comprising both healthcare professionals and community members. Data were analysed thematically through manual coding, applying inductive and deductive approaches, in line with established qualitative analytical frameworks.

Results

The study included a total of 60 participants, 28 healthcare professionals who participated in FGDs (25) and IDIs (3) and 32 community members who participated in FGDs. Major causes of fever, according to healthcare professionals, were upper and lower respiratory infections, malaria, diarrhoeal diseases and COVID-19. The diagnostic approach for febrile patients primarily included screening, malaria testing and other non-specific investigations depending on availability at health facilities. Antibiotics and antipyretics were the most commonly prescribed treatments. The healthcare professionals reported a decrease in prescribing antimalarials due to extensive training on malaria case management. In contrast, community members reported relying primarily on home-based and traditional practices to treat acute febrile illness before seeking care at health facilities. These practices are related to sociocultural habits, such as the use of traditional medicine and self-medication. The main barriers to seeking care at health facilities were the perception of poor quality of care, long waiting times, cultural beliefs and lack of medicines.

Conclusion

Proper management of non-malarial febrile illness remains a major challenge for both healthcare professionals and communities. Training, adherence to case management protocols and efforts to change behaviours to mitigate harmful sociocultural practices are urgently necessary to improve febrile illness management.

Novel use of arm ergometry cardiopulmonary exercise testing for non-elective patients with chronic limb-threatening ischaemia: a feasibility trial

Por: Hodge · S. · Haque · A. · Quraishi-Akhtar · T. · Bryan · A. · Rogers · S. · Bowling · F. L. · Ghosh · J.
Objectives

To evaluate the feasibility, safety and acceptability of arm crank ergometry cardiopulmonary exercise testing (CPETarm) in patients with chronic limb threatening ischaemia (CLTI).

Design

Prospective feasibility single-arm cohort study.

Setting

A tertiary vascular surgery referral centre in Greater Manchester, UK.

Participants

Adult inpatients admitted with CLTI and scheduled for non-elective vascular intervention.

Interventions

Participants underwent bedside CPETarm using an incremental ramp protocol. Cardiopulmonary parameters measured included peak oxygen uptake, anaerobic threshold (AT), ventilatory equivalent for carbon dioxide at AT, peak work rate, oxygen pulse, maximum heart rate and respiratory exchange ratio.

Primary and secondary outcome measures

Primary outcomes were feasibility domains including eligibility, recruitment, test completion, safety, practicality, implementation and patient acceptability. Secondary outcomes included the ability to obtain clinically relevant CPET variables for perioperative risk stratification.

Results

60 patients underwent CPETarm. 74% of CLTI inpatients met eligibility criteria and 71% of eligible patients consented to testing. CPETarm was completed to volitional exhaustion by 95% of participants, with anaerobic threshold identified in 68%. No major adverse events occurred during testing or within 24 hours post-test. 90% of CPETarm assessments were completed within 48 hours of the decision to proceed with intervention, without delaying surgery. The procedure was well tolerated and acceptable to patients.

Conclusions

CPETarm is a feasible, safe and acceptable method for preoperative assessment in patients with CLTI who are unsuitable for conventional lower-limb CPET. Further research is required to establish modality-specific thresholds, evaluate prognostic value for postoperative outcomes and evaluate integration into perioperative care pathways.

Trial registration number

NCT06404229.

Association between the use of anti-herpetic drugs and subsequent initiation of Alzheimers disease drug treatment: Dutch population-based inception cohort study

Por: Alghamdi · A. · Balafas · S. · Bos · J. H. J. · van Munster · B. C. · Rafie · K. · Dolga · A. M. · Hak · E.
Objectives

To examine whether exposure to anti-herpetic drugs (AHDs: acyclovir, valacyclovir, famciclovir) is associated with reduced risk of Alzheimer’s disease (AD) treatment initiation.

Design

Population-based retrospective matched cohort study.

Setting

University Groningen community pharmacy database IADB.nl, covering approximately 125 Dutch pharmacies (1994–2024).

Participants

262 757 adults aged 50–80 years without prior dementia or AD treatment. Exposed individuals with antiherpetic prescriptions (n=23 887) were matched 1:10 to unexposed controls (n=238 870) by age, sex and calendar time.

Intervention

AHDs: acyclovir, valacyclovir, famciclovir.

Main outcome measures

Initiation of AD drug treatment, defined as at least two prescriptions for rivastigmine, donepezil, galantamine or memantine within 1 year. Cox proportional hazards models estimated HRs with 95% CIs, adjusted for comorbidities and medications. Analyses were stratified by period (1994–2018 vs 2019–2024) and drug type.

Results

During follow-up, 2495 participants initiated AD treatment. The age of the participants was 65 (SD 9), and 59% were female. Any AHD exposure was associated with 90% reduced hazard of AD treatment (HR 0.09, 95% CI 0.07 to 0.13, p

Conclusions

AHD exposure was consistently associated with markedly lower risk of AD treatment initiation, with similar findings observed in recent years. These findings support the hypothesis that herpesvirus reactivation may contribute to AD pathogenesis and suggest antiviral therapy could have preventive implications. Confirmation through prospective studies and randomised trials is needed.

Interdependent relationship between depression and Internet gaming disorder in parent-child dyads: The mediating role of family relationship and gaming time

by Qian Li, Yilun Huang, Samuel Yeung-Shan Wong, Winnie W. S. Mak, Xue Yang

Background and objective

A well-established link exists between depression and Internet gaming disorder (IGD) at the individual level, while it remains unexplored within the family system. This study aims to investigate the interdependent relationship between parent and adolescent depression and IGD, and to identify the potential mechanisms.

Methods

A cross-sectional dyadic study was conducted with adolescents and their parents (primary caregiver) in Hong Kong. Adolescents completed anonymous surveys in classrooms, and parents completed online surveys via WhatsApp or phone interviews. The Actor-Partner Interdependence Model (APIM) and Actor-Partner Interdependence Mediation Model (APIMeM) were utilized to test the interdependence and mediators between depression and IGD in parent-child dyads, respectively.

Results

A total of 1,277 parent-child dyads were included. Depressive symptoms in parents (β = 0.072) and adolescents (β = 0.273, both p  Conclusions

Adolescent depressive symptoms were positively associated with their own and parental IGD symptoms, which were mediated by adolescent-reported family relationships and adolescent gaming time. The influence of adolescents’ mental health problems on parents’ problematic behaviors within the family system should not be overlooked.

Add-on tocilizumab versus placebo for resistant major depression in psychiatric outpatients with low-grade inflammation in a tertiary public hospital in Southern Brazil: randomised triple-blind clinical trial protocol

Por: Portal · P. H. G. · Peixoto · G. N. · de Matos · M. R. · da Silva · L. C. N. · Alexandrino · G. B. · Dutra · P. H. G. · Carniel · B. P. · da Rocha · N. S.
Introduction

Emerging evidence supports a role for interleukin 6 (IL-6), a pro-inflammatory cytokine, in the pathogenesis of treatment-resistant major depressive disorder (TRD). However, interventional studies targeting IL-6 in this population remain scarce. Tocilizumab is a humanised monoclonal antibody that inhibits IL-6 signalling and is approved for the treatment of autoimmune conditions such as rheumatoid arthritis. The primary objective of this study is to examine whether IL-6 inhibition via tocilizumab can impact depressive symptoms, inflammation-related biomarkers and cognition in patients with TRD. A secondary objective is to compare the biological profiles of patients with TRD with elevated inflammation to those of healthy controls.

Methods and analysis

This is a proof-of-concept, randomised, parallel-group, triple-blind, placebo-controlled clinical trial. 22 adult outpatients diagnosed with TRD and evidence of low-grade inflammation (serum C reactive protein≥3 mg/L) will be randomised (1:1) to receive either one intravenous infusion of tocilizumab (8 mg/kg; maximum 800 mg) or normal saline, administered as an add-on to their ongoing treatment. Psychiatric, cognitive and biomarker assessments will be performed at baseline and at follow-up visits on days 7, 14 and 28 post-infusion. Additionally, 10 healthy controls with no psychiatric history will undergo the same baseline assessments for biomarker comparison.

Ethics and dissemination

The study has been approved by the Research Ethics Committee of the Hospital de Clínicas de Porto Alegre (Project number: 2025-0245, CAAE: 88904825.7.0000.5327). Findings will be disseminated through peer-reviewed publications, scientific meetings and, on request, lay summaries for participants.

Trial registration number

NCT07052058.

Effect of a culturally adapted heart-healthy diet with phytosterols and/or krill oil on lipid-related outcomes in familial hypercholesterolaemia: protocol for a multicentre randomised controlled trial in Brazil

Introduction

An affordable heart-healthy dietary approach is essential for the management of familial hypercholesterolaemia (FH); however, the optimal dietary pattern and the role of adjunctive nutrient supplementation remain uncertain. This study aims to evaluate the effects of the Brazilian Cardioprotective Diet (DICA Br), adapted from the Portfolio Diet, with or without phytosterol and/or krill oil supplementation in individuals with probable or definite FH according to the Dutch Lipid Clinic Network (Dutch MEDPED) criteria.

Methods and analysis

The DICA-FH study is a national, multicentre, randomised, factorial, parallel-group, superiority, placebo-controlled clinical trial with a 1:1:1:1 allocation ratio. Participants aged ≥16 years receiving age-appropriate lipid-lowering therapy will be randomised into four groups: (1) adapted cardioprotective diet (DICA-FH) plus phytosterol placebo and krill oil placebo; (2) DICA-FH plus phytosterol 2 g/day and krill oil placebo; (3) DICA-FH plus phytosterol placebo and krill oil 2 g/day or (4) DICA-FH plus phytosterol 2 g/day and krill oil 2 g/day. All participants will undergo whole-genome sequencing and receive appropriate genetic counselling. Primary outcomes will be means of low-density lipoprotein cholesterol and lipoprotein(a) levels after 120 days. Secondary outcomes will include additional lipid biomarkers, adherence to protocol and adverse events. The planned sample size is 300 participants. Follow-up is expected to conclude in July 2026.

Ethics and dissemination

This study was registered under CAAE 65549622.2.1001.0060 and received ethical approval from the Hcor Research Ethics Committee (approval number 5.805.072) and the Brazilian National Research Ethics Commission (CONEP; approval number 6.864.951). Written informed consent will be obtained from all participants prior to enrolment. The study findings will be disseminated through peer-reviewed publications, scientific conferences and channels aimed at the general public.

Trial registration number

NCT06331195.

Social network structure and depression by gender in rural Honduras: a cross-sectional study

Objectives

To assess the relationship between the structural position of individuals within their village network and symptoms of depression and postpartum depression, among men and women.

Design

Community-based, observational, cross-sectional study.

Setting

176 villages in the Copan region of Honduras.

Participants

Village residents, comprising 25 605 adults surveyed in a census-based study; using data collected between October 2015 and December 2019.

Outcomes

Symptoms of depression and postpartum depression, among men and women.

Results

Across all participants, 34.99% reported depression symptoms (40.50% for women and 27.62% for men). Among recent parents with a new child in the last 6 months, 28.89% reported postpartum depression symptoms (31.29% for women and 24.31% for men). Women with higher social intransitivity (ie, a greater proportion of friend-pairs among their friends that were not themselves connected) had higher odds of depression symptoms (OR=1.27, 95% CI 1.14 to 1.41), an association not found for men nor in postpartum parents. Because this coefficient is estimated on a 0–1 scale, it corresponds to approximately 2.4% higher odds of depression per 10 percentage-point increase in social intransitivity. In a signed-network decomposition that also included adversarial ties, only the proportion of incomplete/no-tie friend-pairs was associated with depression in women (OR=1.03, 95% CI 1.01 to 1.04), corresponding to approximately 3% higher odds of depression per 10 percentage-point increase.

Conclusions

We report that structural social network position and connectedness beyond dyadic ties, including the friendships and adversarial ties of a person’s friends, are associated with depression. These findings highlight the importance of linking psychological health to broader social connections in the context of face-to-face relationships.

Minocycline hydrochloride ointment-assisted periodontal treatment of stage III/IV periodontitis associated with type 2 diabetes mellitus targeting Chinese people: study protocol for a randomised controlled trial

Por: Zhao · H. · Lin · S. · He · L. · Zhen · M. · Yang · G. · Wang · X. · Cao · J. · Li · Y. · Hou · J. · Xu · L. · Meng · H. · Liu · K.
Introduction

Scaling and root planing (SRP) combined with adjunctive antibiotic therapy is widely adopted in the management of periodontitis in patients with type 2 diabetes mellitus (T2DM), with the aims of ameliorating glycaemic control, alleviating local inflammation and facilitating periodontal tissue regeneration. As a topically administered adjunctive antibiotic for periodontal treatment, minocycline hydrochloride (MH) ointment has shown favourable clinical efficacy in systemically healthy patients with periodontitis. However, robust evidence supporting its clinical efficacy and potential glycaemic-improving effects in patients with periodontitis complicated by T2DM remains limited. The present study is designed to test the null hypothesis that no significant differences in clinical outcomes exist between SRP combined with MH and SRP alone in the management of periodontitis among patients with T2DM, with its primary objective to investigate whether MH as an SRP adjunct confers superior clinical benefits to SRP alone.

Methods and analysis

We will conduct a randomised, single-blind, placebo-controlled clinical trial. 56 patients with T2DM-associated stage III/IV periodontitis will be recruited from the Department of Periodontology, Peking University School and Hospital of Stomatology, Beijing, China. Eligible participants will be randomised into two groups: the experimental group will undergo SRP combined with topically administered MH ointment and the control group will undergo SRP with a matched placebo. The primary outcomes will include probing depth (PD) changes at periodontal pocket sites with a baseline PD ≥6 mm at 6 months post-baseline, with a specific focus on the percentage of such sites with PD reduced to ≤5 mm. The secondary outcomes will comprise PD changes at pocket sites with a baseline PD ≥5 mm at 6 months post-baseline, as well as clinical attachment loss, the plaque index, bleeding index, the levels of IL-1β, IL-17, calprotectin and insulin levels in gingival crevicular fluid and serum, complete blood count, blood biochemistry, including glycated haemoglobin levels, and the composition of subgingival plaques at baseline, and 2 and 6 months post-baseline.

Ethics and dissemination

This study was approved by the Ethics Committee of Peking University School and Hospital of Stomatology (PKUSSIRB-2024102139b). Results will be published in a peer-reviewed scientific journal.

Trial registration number

ChiCTR2400092305.

Protocol version

V.3.1 (date: 6 January 2026).

Difficult intravenous access (DIVA) in the adult population: an umbrella review

Por: Torne-Ruiz · A. · Delgado · M. · Moreno · S. · Corral-Nunez · A. · Cemeli · T. · Roca · J.
Objectives

To synthesise evidence from systematic reviews on difficult intravenous access (DIVA) in adults, focusing on definitions, diagnostic criteria, risk factors and clinical interventions to guide clinical practice and health policy.

Design

Umbrella review of systematic reviews and meta-analyses.

Setting

Any clinical setting involving adult patients requiring peripheral venous access (including hospital, emergency and outpatient care).

Data sources

A systematic search was performed in PubMed, CINAHL, Cochrane, Scopus and Web of Science in July 2025.

Eligibility criteria

Systematic reviews and meta-analyses published from 2014 to 2025 that addressed DIVA in the adult population were included. Primary studies and protocols were excluded.

Data extraction and synthesis

Methodological quality was assessed using the Risk Of Bias In Systematic Reviews tool. Data extraction followed the Joanna Briggs Institute methodology for overviews and the Preferred Reporting Items for Overviews of Reviews reporting guideline.

Results

Seven reviews (six systematic reviews and one meta-analysis) were included. Three analytical dimensions emerged: (1) the conceptual and operational definition of DIVA, identifying common elements such as ≥2 failed attempts, lack of visible or palpable veins and a documented history of difficult access; (2) risk factors and clinical assessment, highlighting obesity, chronic diseases, prior chemotherapy, venous invisibility or non-palpability and the limited validation of diagnostic tools and (3) interventions, including organisational strategies (escalation protocols, specialised teams), technological resources (ultrasound guidance) and clinical measures (pain management and technique optimisation).

Conclusions

DIVA is a multifactorial challenge that requires a standardised definition to improve clinical identification. Effective management relies on a combination of specialised training, the use of ultrasound technology and the implementation of escalation protocols to ensure patient safety and efficiency.

PROSPERO registration number

CRD420251084947.

Enhancing screening, early diagnosis and treatment initiation of oral, breast and cervical cancer in selected districts of India: an implementation research protocol

Por: Kankaria · A. · Shukla · P. · Vijayakumar · M. · Sachdeva · A. · Subramanian · M. J. · Borah · P. K. · Sahoo · S. S. · Nirgude · A. · Prusty · R. K. · T S · S. · Asuri · K. · Verma · P. · Sharma · J. · Dhaliwal · R. S. · Begum · S. · Kaur · T. · ICMR-NHRP Cancer Screening Group · Bhatla
Introduction

Despite implementation of the National Programme for Prevention and Control of Non-Communicable Diseases (NP-NCD), screening coverage for oral, breast and cervical cancers remains below 2%. Screening quality is inadequately addressed and delays in diagnosis and treatment initiation continue to persist. This multisite implementation research aims to improve district-level coverage and quality of screening, early diagnosis and timeliness of treatment initiation through a model co-developed within the NP-NCD context.

Methods and analysis

The study will be conducted in three phases across seven districts in diverse regions of India. In phase I (formative), the current status, barriers and facilitators of cancer screening, diagnosis and treatment initiation under NP-NCD will be assessed. In phase II (optimisation), a model (package of implementation strategies) will be co-developed and iteratively optimised with multistakeholder engagement at the subdistrict level to improve screening coverage and quality and strengthen the referral system for early diagnosis and treatment initiation. In phase III (scale-up and evaluation), the model will be implemented at the district level and evaluated for improvements in screening, early diagnosis and treatment initiation. A convergent mixed-methods design will be used, incorporating household surveys, facility assessments and stakeholder interviews. Implementation Research Logic Model will guide planning, execution and evaluation in the present study. Determinants of screening coverage and quality, early diagnosis and treatment initiation will be assessed using the Consolidated Framework for Implementation Research. Implementation strategies for the model will be finalised using the Expert Recommendations for Implementing Change framework. Implementation and service outcomes will be evaluated using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework.

Ethics and dissemination

Ethical approval has been obtained from all study sites. The study findings will be disseminated at the state, national and global levels through meetings and conferences and submitted to a peer-reviewed journal for publication.

Trial registration number

CTRI/2025/08/092672.

Barriers and facilitators to service utilisation and management of sexually transmitted infections in India: a multicentric mixed-method approach study protocol

Por: Aggarwal · S. · Khandekar · J. · Banerjee · B. · Agarwal · P. · Paul · S. · Parashar · M. · Goel · A. D. · Lakshmi · P. V. M. · Datkhile · K. · Naik · B. N. · Goel · M. · Verma · V. · Rajan · S. · Das · C. · Nigam · K.
Introduction

Sexually transmitted infections (STIs) have emerged as significant public health concerns, imposing a substantial burden on both individuals and the healthcare system of the country. Additionally, STIs may also result in major extensive psychological consequences that profoundly affect individuals with STIs. Despite the government’s implementation of different initiatives aimed at addressing STI-related challenges, these conditions are associated with shame and stigma which act as barriers to the effective utilisation of healthcare services. The purpose of the present study is to generate evidence on barriers and facilitators to service utilisation and management of STIs in India.

Methods and analysis

Indian Council of Medical Research, New Delhi, is conducting a multi-centre study employing a mixed-method approach. The study involves different levels of healthcare systems, including both government and private healthcare facilities across seven sites in several states of India, including Maharashtra, Rajasthan, Punjab, Bihar, Uttar Pradesh and New Delhi. For the quantitative data, individuals seeking healthcare services related to STIs will be enrolled and assessed using a semi-structured pilot-tested questionnaire. In-depth interviews and focus group discussions will also be conducted with different stakeholders as per the standard guidelines of the qualitative method by the designated trained project staff. Descriptive and inferential statistics will be applied to the quantitative data, while the qualitative data will be analysed using a deductive approach with thematic content analysis.

Ethics and dissemination

The study protocol has been approved by the ethics review committees of all the participating sites individually. The findings from this study will be published in peer-reviewed journals and disseminated through scientific conferences and meetings among policy-makers and government agencies. AIIMS/IEC/2024/609; AIIMS/Pat/IEC/2024/1205; F. 7/BIOETHICS/AIIMS-RBL/APPROEM/2021/1; KIMSDU/IEC/11/2022; LHMC/IEC/2024/11; IEC/02/EX/2024; PGI/IEC/2024EIC000373.

Use of clips to prevent delayed post-polypectomy bleeding in non-pedunculated colorectal lesions: protocol for a systematic review and meta-analysis

Por: Wei · Y. · Zhang · S. · Mabenga · H. S. · Ngowi · B. J. · Jin · Z.
Introduction

Delayed post-polypectomy bleeding (DPPB) remains a significant complication of endoscopic resection, contributing to morbidity and increased healthcare costs. Although prophylactic clipping is widely practised to mitigate this risk, evidence from recent randomised controlled trials (RCTs) regarding its efficacy is inconsistent. This protocol outlines a systematic review and meta-analysis to evaluate the effectiveness of prophylactic clips following thermal resection.

Methods and analysis

We will conduct a comprehensive search of MEDLINE, EMBASE and the Cochrane Library from inception to 10 February 2026, to identify RCTs comparing prophylactic clips vs no clips in patients undergoing thermal endoscopic resection of non-pedunculated polyps. The primary outcome is DPPB within 30 days, defined as overt bleeding requiring medical intervention or a haemoglobin decrease ≥2 g/dL. Secondary outcomes include DPPB in proximal large (≥20 mm) lesions, perforation, post-polypectomy syndrome and procedure time. Data synthesis will use a random-effects model. Methodological quality will be assessed using the Cochrane Risk of Bias 2 tool. Publication bias will be visualised using funnel plots. We will quantify the effect of potential effect modifiers by meta-regression if appropriate. The quality of evidence will be evaluated according to the Grading of Recommendations Assessment, Development and Evaluation framework.

Ethics and dissemination

This study will not use primary data, and therefore formal ethical approval is not required. The findings will be disseminated through peer-reviewed journals and committee conferences.

PROSPERO registration number

CRD420251246840.

Surgery or radiotherapy for early-stage cancer study protocol for an emulated target trial of radical radiotherapy versus radical cystectomy, with either following neoadjuvant chemotherapy, for organ-confined muscle-invasive bladder cancer

Por: Kagenaar · E. · Lugo-Palacios · D. G. · Bromley · H. · Aggarwal · A. · Hutchings · A. · ONeill · S. · Rachet · B. · Cresswell · J. · Choudhury · A. · Grieve · R.
Introduction

Neoadjuvant chemotherapy (NAC) followed by definitive treatment consisting of either radical radiotherapy or radical cystectomy is the recommended treatment for patients with organ-confined muscle-invasive bladder cancer (OC-MIBC). A randomised controlled trial (RCT) aimed to compare the effectiveness of radical radiotherapy and radical cystectomy but failed to recruit. Radical radiotherapy is non-invasive and organ-preserving, and observational studies have suggested this treatment may be associated with similar outcomes compared with radical cystectomy. However, in these observational studies, the risk of confounding was high, and they did not consider the receipt of NAC. The surgery or radiotherapy (SORT) for the early-stage cancer study will assess the comparative effectiveness and cost-effectiveness of either radical cystectomy or radical radiotherapy, both after NAC for OC-MIBC. We will use a target trial emulation approach to reduce the risk of bias when assessing comparative effectiveness from observational data.

Methods and analysis

The SORT study will use UK’s National Cancer Registry to identify individuals diagnosed with urothelial OC-MIBC (T2-4aN0M0) between 1 January 2015 and 31 December 2021 who received either radical radiotherapy or radical cystectomy after NAC. The data will be linked to Hospital Episode Statistics (HES), National Radiotherapy Data Set (RTDS) and Systemic Anti-Cancer Therapy (SACT) data sets to gather information on clinical, tumour and socio-demographic characteristics and receipt of treatment. Using the target trial emulation framework, we will define the eligibility criteria and radical radiotherapy and radical cystectomy receipt. To reduce the risk of confounding, we will use advanced statistical approaches to allow for differences in measured baseline characteristics between the comparison groups.

The primary outcome is 3-year all-cause mortality after radical treatment receipt. Secondary outcomes will include all-cause and bladder-cancer-associated mortality at 3 and 5 years, time to death, incremental costs and incremental cost-effectiveness reported according to net health benefits.

Ethics and dissemination

The study was approved by the London School of Hygiene and Tropical Medicine Ethics Committee (Reference number 29717 - 1). Results will be communicated in open-access journals and conferences to clinicians, researchers, patients and policymakers.

Effect of supplemental hydrocortisone during stress in prednisolone-induced adrenal insufficiency: a study protocol for a multicentre, randomised, double-blinded, placebo-controlled clinical trial on health-related quality of life in patients with polymya

Por: Borresen · S. W. · Hansen · S. B. · Al-Jorani · H. · Tei · R. · Dreyer · A. F. · Boesen · V. B. · Bislev · L. S. · Jorgensen · N. T. · Jensen · R. C. · Bjergstrom · M. L. L. · Christensen · L. L. · Frederiksen · J. S. S. · Glintborg · D. · Bjorner · J. B. · Feldt-Rasmussen · U. · Jor
Introduction

Patients on low-dose prednisolone may develop adrenal insufficiency causing reduced health-related quality of life (HRQoL) and increased risk of adrenal crisis. This study examines whether supplemental hydrocortisone during mild to moderate stress improves HRQoL in patients with polymyalgia rheumatica/giant cell arteritis (PMR/GCA) with adrenal insufficiency on low-dose prednisolone.

Methods and analysis

A multicentre, randomised, double-blinded, placebo-controlled, clinical trial including patients with PMR/GCA receiving ongoing prednisolone ≤5 mg/day. Eligible patients undergo an adrenocorticotropic hormone (ACTH) test, and 250 patients with a stimulated cortisol

Ethics and dissemination

The study is approved by the Ethics Committee of the Capital Region of Denmark and the Danish Medicines Agency. Recruitment began June 2022. The last patient’s last visit is expected in 2026. Results will be disseminated via peer-reviewed publication and conference presentations.

Trial registration numbers

EudraCT:2021-002528-18, CTIS:2024-518272-30-00, NCT05435781.

Pregnancy care-seeking stress in the USA: a prospective cohort study

Por: Biggs · M. A. · Ralph · L. · Foster · D. G. · Arteaga · S. · Rocca · C. H.
Objectives

To prospectively assess pregnancy-related care sought and obstacles and stress experienced by newly pregnant people.

Design

The ADAPT Study, a longitudinal cohort study, followed 2015 non-pregnant participants aged 15–34 years for a year. Those with confirmed incident pregnancies were followed through their pregnancies and for 3 years.

Setting

We recruited participants from 23 reproductive and primary care facilities located in five southwestern states with different sociopolitical reproductive health contexts (restrictive, Arizona and West Texas; protective, southeastern California, Nevada and New Mexico).

Participants

334 people reported a new pregnancy within 1 year of enrolment; 324 with outcome data are included in this analysis.

Primary and secondary outcome measures

Types of pregnancy care sought (‘Have you looked into where or how you could get (prenatal care, abortion care or adoption services)?’) and care-seeking stress (‘How stressful was it to find (prenatal, abortion or adoption) care for this pregnancy?’).

Results

Most participants (83%, 270/324) sought prenatal care; 43% (138/324) sought abortion care; and 5% (17/324) sought adoption services. Overall, 17%, 29% and 23%, respectively, reported that care-seeking was extremely/quite a bit stressful. Abortion care-seeking was associated with significantly more stress than seeking prenatal care in the ordinal (adjusted odds ratio (aOR 1.70, 95% CI 1.10 to 2.62) but not logistic (aOR 1.33, 95% CI 0.74 to 2.38) model. Adoption care-seeking stress did not differ from prenatal care-seeking stress in either model. Participants who experienced any type of abortion care-seeking obstacle and those recruited in a state with a restrictive policy environment (aOR 2.72, 95% CI 1.09 to 6.80) reported more care-seeking stress than their counterparts.

Conclusions

People who seek pregnancy care often experience some care-seeking stress, regardless of the type of care they seek. Findings point to the need to reduce the burden of the pregnancy care-seeking process across all types of pregnancy care.

Trial registration number

NCT03888404.

The association of triglyceride-glucose index with acute myocardial infarction and all-cause mortality in patients with coronary artery disease stratified by acute myocardial infarction status: a large-scale retrospective cohort study from South China

Por: Wang · Y. · Zeng · C. · Huang · Y.-L. · Fang · Y. · Rahmati · A. · Zhou · Z. · Chen · S.
Objectives

This study aimed to investigate the association of the triglyceride-glucose (TyG) index with the risk of acute myocardial infarction (AMI) and all-cause mortality in patients with coronary artery disease (CAD), and to inspect whether AMI mediates the relationship between TyG index and mortality.

Design

A large-scale, retrospective cohort study.

Setting

This single-centre study was conducted at a tertiary academic hospital in South China. The association between the TyG index and AMI was assessed using multivariable logistic regression, with progressive adjustment for demographic and clinical covariates. Cox proportional hazards models were used to estimate the HRs for all-cause mortality associated with TyG index. Restricted cubic splines and mediation analysis were employed to examine non-linear relationships and the mediating role of AMI.

Participants

A total of 20 125 patients diagnosed with CAD during hospitalisation between January 2020 and February 2025 were initially enrolled. After applying exclusion criteria (insufficient data), 18 245 participants were included in the final analysis.

Outcome measures

We examined the association of the TyG index with the risk of AMI, as well as its association with all-cause mortality across different CAD subgroups.

Results

The association between the TyG index and all-cause mortality was significantly modified by AMI status (P for interaction

Conclusions

An elevated TyG index independently predicts the risk of AMI in patients with CAD. Its prognostic value for mortality, however, is critically dependent on the presence of AMI: while a higher TyG index is associated with increased mortality in patients with AMI, moderately elevated TyG levels (Q2–Q3) are associated with lower mortality, whereas the highest quartile shows no significant association. Mediation analysis further reveals that AMI significantly mediates the association between TyG index and mortality, highlighting the importance of AMI prevention in mitigating the adverse prognostic impact of insulin resistance in the CAD population. These findings warrant validation in prospective studies.

Translation and validation of the Norwegian ABCD Risk Questionnaire to assess cardiovascular disease knowledge and risk perception prior to myocardial infarction

Por: De Martin Topranin · V. · Brors · G. · Saether · J. C. · Gerdts · E. · Vangen · S. · Bye · A.
Objectives

The aim of this study was to translate the Attitudes and Beliefs about Cardiovascular Disease (ABCD) Risk Questionnaire into Norwegian and assess its psychometric properties among individuals with a history of myocardial infarction.

Design

The study adopted a cross-sectional design. The original questionnaire was translated into Norwegian and adapted for use in the target population. The Norwegian version was pilot tested in a sample of patients and then validated in the target population.

Setting

Norway, using a web-based solution to collect data.

Patients

A random sample of Norwegian individuals

Main outcome measures

Internal consistency was tested using Cronbach’s α and test–retest reliability using intraclass correlation coefficient (ICC). Difficulty and discrimination indices were determined for the Knowledge scale. Confirmatory factor analysis (CFA) was used to assess structural validity of the Risk scale.

Results

Data for 746 participants (mean age, SD: 66.4, 10.3 years), of which 26.9% females were analysed. The Norwegian version showed satisfactory internal consistency (Cronbach’s α 0.73–0.79) but modest test–retest reliability (ICC 0.35–0.64). The Knowledge scale showed moderate difficulty (0.39–0.84) and good discrimination power (0.44–0.60). The one-factor model CFA for each scale achieved acceptable fit, and the four-factor model showed moderate fit (root mean square error of approximation=0.05, standardised root mean squared residual=0.07, Comparative Fit Index=0.91, Tucker-Lewis Index=0.88).

Conclusions

The Norwegian translated ABCD Risk Questionnaire demonstrated satisfactory psychometric properties and can be considered a useful instrument for assessing knowledge and risk perception among individuals with a history of myocardial infarction.

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