Leprosy remains a significant public health challenge in many low and middle-income countries, including India. People affected by leprosy face multifaceted challenges: physical, psychological, social and economic. In response, donors support self-help groups (SHGs) to improve health, social integration and economic circumstances for marginalised people, including those with leprosy. This study aims to assess the sustainability of SHGs in India after the withdrawal of donor support by examining whether they remain functional and exploring the key factors, barriers and facilitators that influence their long-term social and economic viability.

To examine the functionality of SHGs after withdrawal of donor support, and to explore the factors, barriers and facilitators influencing their long-term social and economic sustainability.

Using qualitative methods, we conducted semistructured interviews with 40 key informants associated with five SHGs formed under the Self-Help Community Development Project implemented in an endemic state of India and funded by The Leprosy Mission Trust India.

It was an exploratory qualitative study using interviews with SHG members and key informants, situated within the self-help community-based project.

While some SHGs demonstrated resilience and adaptability, others faced challenges such as internal discord, loss of members to migration and lack of access to government schemes. Thematic analysis revealed key drivers and barriers to sustainability and realising the benefits of SHGs, highlighting variations in leadership, governance, economic performance and social engagement across groups.

SHGs are often sustained after the funding and managerial donor support have been withdrawn. The findings emphasise the importance of strong leadership, community support and external facilitation in sustaining SHGs and enhancing their impact on marginalised populations. This study contributes to understanding the role of SHGs in addressing the socioeconomic challenges faced by individuals affected by leprosy and offers insights for improving their long-term viability.

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/).

Although multiple studies have offered self-collection for human papillomavirus (HPV)-based cervical screening in community settings, there are no randomised controlled trials (RCTs) that have compared implementation outcomes of programme approaches for self-collection. This trial will compare two such approaches in low-resource settings in the states of Tamil Nadu and Mizoram, India.

A cluster RCT will be conducted over a year, offering self-collection to 3000 women aged 30–49 from 28 clusters (average size 101) in selected districts. Clusters in tribal, rural and urban low-income settings will be randomised to two arms. The intervention arm, co-designed with multiple stakeholders, will involve campaigns to offer self-collection in the community. The comparison arm will be offered self-collection at the nearest health facilities.

HPV-based cervical screening will be performed at central laboratories using clinically validated screening assays that can identify the highest risk carcinogenic HPV types (Group 1a–c - HPV16/18/31/33/45/52/58, ±35). Ablative treatment will be based on positivity with this extended genotyping triage, while those with any of the lower carcinogenic HPV types (Group 1d - 39, 51, 56, 59, ±35, Groups 2a/b - 66, 68) will undergo further assessment with visual inspection with acetic acid. Outcomes will be evaluated quantitatively and qualitatively using RE-AIM and the Theoretical Framework of Acceptability.

The primary outcome will be percentage of women well-managed (screened and appropriately treated) in both arms, with secondary outcomes including proportion screened, proportion treated, acceptability (willingness to screen, rescreen, and/or recommend to others) to women, community and healthcare providers, adoption (by providers), implementation fidelity, costs, sustainability assessment and systematically identified implementation barriers and facilitators. The reach, effectiveness and acceptability of community-based self-collection and the use of extended genotyping for triage in resource-constrained, hard-to-reach populations will be assessed, with lessons that can inform future statewide and national programmes.

Ethics approval has been obtained from the Institutional Review Board (IRB) and Ethics Committee of the Christian Medical College Vellore, Tamil Nadu, India (IRB Min. No 14314; INTERVEN), the Alfred Hospital Ethics Committee (HREC Ref 80134, Local Reference: project 601/21), Melbourne, Australia, the IARC Ethics Committee (IEC 21-32), Lyon, France, the Salem Polyclinic Institutional Ethics Committee (SPCIEC/2022/June/01/02), Tamil Nadu, India and the Institutional Ethics Committee, Civil Hospital, Aizawl, Mizoram, India (No.B.12018/1/13-CHA(A)/IEC/115). The study is also approved by the State Scientific Advisory Committee, Directorate of Public Health and Preventive Medicine, Chennai, Tamil Nadu (R. No. 011575/HEB/A2/2023). The Alfred Hospital Approval, as an authorised Australian ethics committee for national mutual recognition, is recognised and registered with the University of Melbourne Human Research Ethics Committee (2024-25255-57650-1). Written informed consent will be obtained from participants. The results of the trial will be disseminated through a peer-reviewed medical journal, and also through workshops, reports and conferences.

The trial has been registered with the Clinical Trials Registry - India: CTRI/2022/04/042327.

Research on the impact of smoking behaviour across generations has primarily focused on grandmaternal smoking during pregnancy. However, the broader multigenerational effects of smoking behaviour, notably through environmental and behavioural pathways, remain underexplored. This study evaluated previous studies on the possibility of transgenerational transmission, rather than in utero transmission, regarding the effects of grandparental smoking behaviour on offspring’s development outcomes.

This study is a systematic review with qualitative evidence synthesis.

A comprehensive search was conducted across multiple online databases, including PubMed, EBSCOhost, Web of Science and Scopus. To ensure a broad scope of relevant studies, publication dates, study locations and language were restricted to English only.

After duplicates were removed, 3916 articles remained from the 4133 identified articles. Based on the predefined eligibility criteria, 38 articles were selected for full-text assessment. The selection process involved multiple reviewers, with disagreements resolved through consensus.

Multiple reviewers independently extracted data using a standardised protocol. The Joanna Briggs Institute critical appraisal tool was used to assess the quality of the included studies, with inter-rater reliability tests indicating moderate-to-high agreement. Extracted data included study design, participant demographics, exposure details and measured outcomes.

This systematic review included seven studies because of heterogeneity in reported outcomes and effect measures. Three independent reviewers extracted data using a standardised coding sheet. The synthesis compared methodologies, identified gaps, key findings and conclusions across studies.

Seven included articles examined grandchildren’s behaviour, such as hyperactivity disorder, oppositional defiant disorder and conduct problems, body composition and IQ concerning grandparents’ smoking habits. Most studies used robust statistical methods; two included parental factors as mediators. The synthesis of results indicated that the associations were primarily indirect. Key findings revealed that grandparents’ smoking status was significantly associated with their grandchildren’s physical and cognitive outcomes. Furthermore, the reviewed studies demonstrated sex-specific transgenerational effects of ancestral smoking on grandchildren’s health, with stronger effects often observed in male descendants.

This review highlights the methods and findings of previous studies on the potential transgenerational transmissions through which grandparents’ smoking behaviour may influence grandchildren’s behavioural, physical and cognitive development. Although the findings emphasise the importance of environmental and behavioural factors, further research is needed to address existing gaps and clarify mechanisms.

This systematic review protocol was registered in the PROSPERO database under registration number CRD42024571725.

Photobiomodulation (PBM) has shown promising effects in managing postoperative pain following conventional periapical surgery, although current evidence remains limited. This study aims to assess the effect of PBM on postoperative pain 24 hours after periapical surgery.

A randomised, controlled, double-blind trial will include 34 patients undergoing periapical surgery in the maxillary region, randomly assigned to an experimental group (n=17) or control group (n=17). The experimental group will receive PBM (GaAlAs diode laser, 808 nm, 100 mW, 4 J/cm², applied at five vestibular points) and placebo ibuprofen immediately and 24 hours postoperatively. The control group will receive simulated PBM and active ibuprofen. The primary outcome is postoperative pain assessed by the visual analogue scale at 24 hours. Secondary outcomes include pain at the seventh day, paracetamol intake, oedema, ecchymosis, soft tissue status and temperature at 24 hours and 7 days. Radiographic evaluation of healing will be performed at 1 and 3 months. Statistical analysis will be conducted based on data distribution, using repeated measures ANOVA (Analysis of Variance) or non-parametric equivalents for longitudinal outcomes, and appropriate tests for categorical variables. Significance will be set at p

The study was approved by the Human Research Ethics Committee of Universidad Católica del Uruguay (process no. 220914). Results will be disseminated to participants, healthcare professionals, the public and scientific communities.

NCT05935306.

Dementia is a chronic and progressive neurological condition characterised by cognitive and functional impairment. It is often associated with multimorbidity and imposes a significant economic burden on healthcare systems and families, especially in low-income and middle-income countries. In Peru, where dementia cases are increasing rapidly, timely detection and referral for diagnosis is crucial. This protocol is part of the IMPACT Salud project in Peru. Here, we focus on a specific component aimed at validating an mHealth tool for the detection of cognitive and functional impairment and assessing its cost-effectiveness. We will also assess changes in cognitive and functional impairment as well as health economic outcomes over 1 year.

This observational study will be conducted in four geographically diverse regions of Peru. Community health workers are expected to contact approximately 32 000 participants (≥60 years) to apply an mHealth-enabled tool that includes cognitive and functional instruments: Ascertain Dementia 8, Peruvian version of Rowland Universal Dementia Assessment Scale and Pfeffer Functional Activities Questionnaire. From this large sample, we aim to find 3600 participants and their study partners to enrol and interview at baseline regarding sociodemographic characteristics, lifestyles, comorbidities and health economic data including resource use, costs and health-related quality of life (HR-QoL). Psychologists, blind to previous results, will assess dementia stage of the participants using an abbreviated Clinical Dementia Rating (CDR) scale. At 6-month follow-up, participants will complete a brief health economics questionnaire on resource use, costs and HR-QoL. To validate the accuracy of the detection tool, a subsample of 600 participants who completed the baseline will undergo a gold-standard clinical neuropsychological assessment. This subsample will participate in a 12-month follow-up, including health economics, cognitive and functional impairment tests and the CDR scale. Results will be analysed and presented by cognitive status, site, sex and multimorbidity profile. Finally, data from all stages and external sources will inform a decision model to implement a cost-effectiveness analysis of the detection tool at the national level.

The study received ethics approval in Peru (Universidad Peruana Cayetano Heredia: CONSTANCIA-CIEI-378-33-23) and in the UK (Imperial College London: ICREC/SETREC reference number 6647445). Informed consent will be obtained from participants and their study partners, considering the participant’s capacity to consent. For illiterate participants, consent will be obtained through a witnessed procedure involving study partners, with a fingerprint obtained instead of a signature. The results will be disseminated through conferences, published articles, public presentations (particularly to those involved in dementia care) and presentations or meetings with local health authorities.

A ‘7-1-7’ timeliness metric, developed for hastening the response to infectious disease outbreaks/pandemics, was adapted to improve screening and managing household contacts (HHCs) of pulmonary tuberculosis (TB) patients. The feasibility, enablers, challenges and utility of implementing this modified metric through TB Champions (TB survivors) for HHC management were assessed.

This was an explanatory mixed-methods study with a cohort design (quantitative) followed by a descriptive design with focus group discussions (qualitative).

The study was conducted within routine programmatic settings in public health facilities in six districts from three states of India.

In total, 595 drug-susceptible index pulmonary TB patients registered for treatment in the selected health facilities, and their listed 2108 HHCs were included in the study between December 2022 and August 2023. All 17 TB Champions involved in implementation participated in the focus group discussions.

The primary outcome measures were the percentage of eligible participants receiving the desired service within the ‘7-1-7’ timeliness metric and challenges in achieving the timeliness metrics.

In 89% of 595 index patients, their HHCs were line-listed within 7 days of initiating anti-TB treatment (‘First-7’). In 90% of 2108 HHCs, screening outcomes were ascertained within 1 day of line-listing (‘Next-1’). In 42% of 2073 HHCs eligible for further evaluation, anti-TB treatment, TB preventive treatment (TPT) or a decision to not receive medication were made within 7 days of screening (‘Second-7’). Barriers to TPT uptake included lack of money and daily wage losses for travelling to clinics, reluctance of asymptomatic contacts to take medication and fear of adverse events. TB Champions felt timeliness metrics improved performance in the systematic and timely management of HHCs.

TB Champions found ‘7-1-7’ timeliness metrics were feasible and useful, and national TB programmes should consider their operationalisation.

Safety culture is essential to improving healthcare quality. Paediatric emergency departments are high-risk environments where evaluating safety culture helps identify areas for improvement. This study aimed to analyse the safety culture among professionals in paediatric emergency departments, according to job category and gender.

Multicentre cross-sectional study using the Hospital Survey on Patient Safety Culture (HSOPSC).

19 paediatric emergency departments, covering all levels of care.

1843 healthcare professionals were invited to participate; the response rate was 63.8%, and 33% of respondents were nurses. All clinical staff in paediatric emergency departments were eligible. Professionals from other specialties and non-clinical staff were excluded.

The primary outcome was the assessment of patient safety culture using the HSOPSC, following the methodology of the Agency for Healthcare Research and Quality. Secondary outcomes included comparisons by job category and gender, and an exploratory cluster analysis.

In terms of patient safety, the main strength was ‘teamwork within units’ (83.65% positive), while the main weakness was ‘staffing’ (61.92% negative). Patient safety was rated with an average score of 7.21 by the participants. Paediatricians rated ‘manager expectations’ significantly higher than nurses (p=0.023) and residents (p=0.026). Paediatricians gave more positive responses overall, with significant differences in ‘communication openness’, ‘feedback and communication’, ‘non-punitive response’ and ‘teamwork across units’, though none were classified as strengths. Cluster analysis showed that the group with more paediatricians identified more strengths and no weaknesses, while the group with more nurses and nursing assistants showed no strengths and significant weaknesses in ‘overall safety perception’, ‘staffing’ and ‘management support’.

Safety culture in paediatric emergency departments is acceptable, but still far from excellent, indicating ample room for improvement. Differences between professional categories, especially between paediatricians and nurses, highlight the need for targeted safety strategies and leadership involvement.

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.

NCT06581965.

Ultrasonography is a non-invasive and safe method for assessing muscle morphology. Among its parameters, echo intensity (EI), derived from grayscale image analysis, has emerged as a promising indicator of muscle quality and intramuscular fat infiltration. This study aims to validate EI as a marker for evaluating muscle quality in a population of Czech children, through integration with gold-standard assessments of muscle strength and body composition. The primary aim of this study is to assess the reliability and construct validity of quadriceps muscle EI using ultrasound as a proxy measure of morphological muscle quality in children aged 10–14 years.

Children aged 10–14 years will undergo ultrasound assessment of the quadriceps femoris (QF). EI will be derived from longitudinal scans of each QF head and the cross-sectional area (CSA_QF) from panoramic mid-thigh images. Muscle function will be assessed as maximal voluntary contraction (MVC) of isometric knee extension with muscle quality expressed as MVC/CSA_QF. A 30 s sit-to-stand test (30STS) will be used as an additional functional measure. EI reliability (intra-rater, inter-rater and test–retest) will be evaluated with intraclass correlation coefficients (ICC), Bland–Altman plots and complementary indices. Exploratory known-groups validity will be tested by comparing EI between weight-status groups. Control variables include dual-energy X-ray absorptiometry (DXA)-derived body composition, skeletal age (as determined by DXA hand scans) and physical activity (assessed using 7-day accelerometry).

This study will include 200 children (100 girls and 100 boys) aged 10–14 years using an a priori power analysis based on the primary objective of assessing construct validity through multiple linear regression, assuming an alpha level of 0.05 and 80% power. Participants will be recruited from paediatric outpatients of the Paediatric Obesity Clinic and individuals reached through a recruitment campaign. Inclusion criteria require general good health, while exclusion criteria include a history or symptoms of cardiovascular, pulmonary, metabolic or neurological disease, as well as the use of over-the-counter or prescribed medications. Informed consent and assent will be obtained from all participants.

Reliability of ultrasound-derived EI will be assessed for intra-rater, inter-rater and test–retest agreement using ICC coefficients, Bland–Altman plots and complementary indices such as SE of measurement, coefficient of variation and minimal detectable change at 95% CI, following Consensus-based Standards for the selection of health Measurement Instruments guidelines. Construct validity will be examined by modelling associations between EI and functional muscle quality (MVC/CSA_QF), with 30STS as an additional functional measure. Known-groups validity will be tested by comparing EI across weight groups, using generalised linear regression models adjusted for skeletal age, body composition and physical activity. All validity analyses will be conducted separately for girls and boys. Ultrasound-derived EI of the QF is expected to show high reliability (ICC≥0.80) and acceptable test–retest reproducibility. Construct validity should be supported by moderate associations with functional muscle quality (MVC/CSA_QF), while known-groups validity is expected to reveal higher EI values in children with obesity and/or insufficient physical activity.

The study will be conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of the Faculty of Physical Education and Sport, Charles University (EK 101/2024). Written parental consent and verbal assent from children will be obtained, with all data handled confidentially and anonymised. Results will be disseminated transparently to participants and their families in line with ethical principles of respect, beneficence and justice.

NCT06792279.

Postpartum depression (PPD) is a debilitating condition affecting over 20% of postpartum women, with disproportionately higher rates among black and Latina women compared with their white counterparts. Current recommendations for PPD prevention demand significant healthcare system resources, highlighting the need for alternative, evidence-based interventions that minimise strain on these systems. Mindfulness has been shown to effectively reduce depressive symptoms and prevent relapse across various populations. However, no studies to date have evaluated the efficacy of a digitally delivered mindfulness intervention specifically for black and Latina women at increased risk of PPD.

This article presents the protocol for the Healthy Mama and Baby study, a randomised controlled trial (RCT). This trial evaluates whether a mobile-based (mHealth) mindfulness intervention tailored for pregnant women reduces depressive symptoms among pregnant black and Latina women at high risk for PPD.

We are conducting a fully remote RCT, recruiting 600 pregnant black and/or Latina women at risk of PPD from Kaiser Permanente Northern California (KPNC), an integrated healthcare delivery system. Participants are enrolled before 30 weeks’ gestation. They are randomised into either an mHealth mindfulness intervention arm, which receives access to a mindfulness app tailored specifically for pregnant and postpartum women, or a time-matched and attention-matched active control arm, which receives access to an online program of calming nature sounds. Both arms are instructed to engage in their assigned program for 5–20 min per day for 6 weeks. Outcome assessments are conducted online at baseline, post intervention and post partum (~7 weeks post partum) using validated questionnaires. Outcomes include depressive symptoms (primary) and anxiety, sleep and perceived stress (secondary).

All study procedures have been approved by the KPNC Institutional Review Board. The findings will be disseminated widely through peer-reviewed publications and conference presentations.

NCT05186272.

Flexible bronchoscopy (FB) is widely used for diagnostic and therapeutic procedures in pulmonary medicine. However, FB can cause respiratory and haemodynamic complications, especially in patients with pre-existing lung and/or cardiovascular comorbidities. Despite the range of oxygenation and ventilatory approaches available to prevent these risks, evidence regarding their real-world application and clinical impact is limited. The OxyFOB study aims to assess the prevalence and outcomes of various oxygenation and ventilatory support strategies used during FB across Europe.

The OxyFOB study is a large, prospective, international, observational cohort study which aims to involve over 10 000 FB procedures across European centres. Eligible participants include all adults undergoing FB for diagnostic, therapeutic or procedural indications. Data are collected via a standardised electronic case report form and encompass demographic information, procedural details and clinical outcomes. The primary endpoint is the prevalence of oxygenation and ventilatory support strategies: conventional oxygen therapy, high-flow oxygen therapy, continuous positive airway pressure, non-invasive ventilation and invasive mechanical ventilation. Secondary outcomes include periprocedural respiratory and haemodynamic events, patient comfort, dyspnoea and postprocedural complications. Statistical analyses include descriptive statistics, subgroup comparisons and multivariate logistic regression.

The study has received ethical approval from the coordinating centre (protocol n. 22/2022 on the 20 January 2022, by the ‘Comitato Etico Sezione Area Centro - Regione Calabria’) and all participating sites. Informed consent is given from all patients or their legal representatives. Findings will be disseminated through peer-reviewed publications and presentations at international meetings. Data will be managed and made available on reasonable request to support further research.

ClinicalTrials.gov ID: NCT05681962. Registered January 2023.

Indigenous Mayan-Yucatecan communities in Mexico have a high prevalence of chronic non-communicable diseases (NCDs) such as diabetes, hypertension, obesity and rheumatic diseases (RMDs). According to the syndemic theory, these diseases combined with social, economic and cultural factors affect the quality of life. The aim of this protocol is to describe the methodological process to create, implement and evaluate a Syndemic-Based Care Model (SCM), using a Community Based-Participatory Research (CBPR) strategy in three Mayan-Yucatecan communities.

This is a convergent mixed-methods protocol. The quantitative component is a before-after study, and the qualitative component is an ethnographic study. The intervention will be a SCM co-constructed with Mayan communities based on their particular needs and aiming for reduction of the negative impact of NCD/RMD through a multidisciplinary approach. We will follow four phases of the CBPR: (1) situational analysis, through community censuses and semistructured interviews to understand the prevalence of NCDs and the syndemics in these communities; (2) co-construction of the elements of a SCM based on the health priorities identified by researchers, community members and healthcare workers; (3) implementation of this SCM and (4) evaluation of the SCM through (1) statistical analyses involving the construction of a syndemic index through stepwise logistic regression of the normalised and standardised key clinical, social and economic variables; interval and ratio variables will be normalised by their z-score and categorical variables will be one-hot encoded; similarity and social networks analysis with clustering to identify syndemic subpopulations; and cost-effectiveness and cost-utility analyses using Markov modelling and (2) narrative and thematic qualitative analysis of the SCM’s implementation and impact on community members’ health, function and quality of life.

Research ethics boards of participant institutions approved this research protocol. This project will be presented to municipal authorities, community meetings and community leaders for observation and acceptance. For people who wish to participate, informed consent will be provided written and verbally in Spanish or Mayan-Yucatecan according to the participant preferences, and it can be signed by either autograph or fingerprint. The results of this research will be disseminated to various groups: (a) local and regional authorities of the Mexican health system and municipal authorities; (b) the participating communities will be informed in an assembly of the results and (c) academic dissemination will be done through publications in public science journals and institutional press releases and will also be presented at national and international congresses or symposia.

Patients with stage III non-small cell lung cancer (NSCLC) are at high risk of developing post-treatment recurrences (50–78%) during follow-up. As more effective treatments are now available, especially for patients with oligometastatic disease, earlier detection of recurrences may prolong survival and health-related quality of life (HRQOL). With the use of 2'-deoxy-2'-[¹⁸F]fluoroglucose positron emission tomography/CT ([¹⁸F]FDG PET/CT) during follow-up, recurrences may be detected earlier. Therefore, the primary objective of this study is to compare the 3-year overall survival of patients with stage III NSCLC during follow-up surveillance with [¹⁸F]FDG PET/CT versus follow-up with conventional CT (usual care). Secondary objectives address the number, location and timing of recurrences, as well as HRQOL, cost-effectiveness and patient experiences of PET/CT scans.

In this multicentre randomised controlled clinical trial, 690 patients with stage III NSCLC (8th edition International Association for the Study of Lung Cancer (IASLC) Tumor, Nodes, Metastasis (TNM) classification) who completed curative intended treatment and started follow-up care (which may include adjuvant therapy) will be randomised 1:1 to either the intervention ([¹⁸F]FDG PET/CT) or the control group (CT). Patients will undergo follow-up scans during visits at 6, 12, 18, 24 and 36 months. Data will be collected using validated questionnaires, electronic case report forms and data extractions from the electronic health records. Additionally, blood samples will be collected, and interviews will be conducted.

The study protocol has been approved by the Medical Ethical Committee of the Radboudumc and review boards of all participating centres. Written informed consent will be obtained from all participants. Study results will be published in international peer-reviewed scientific journals and presented at relevant scientific conferences. Data will be published in a data repository or other online data archive.

NCT06082492.

Post-COVID-19 conditions (PCC) may include pulmonary sequelae, fatigue and other symptoms, but its mechanisms are not fully elucidated.

This study investigated the correlation between fatigue and the presence of pulmonary abnormalities in PCC patients with respiratory involvement 6–12 months after hospitalisation.

Cross-sectional study.

A tertiary hospital in Brazil.

315 patients, aged ≥18 years, were considered eligible based on SARS-CoV-2 infection confirmed by reverse transcription-PCR.

Pulmonary function tests (PFT), cardiopulmonary exercise tests (CPET), chest CT and hand grip were performed. The following scales were applied: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, Euroqol 5 Dimensions quality of life (EQ-5D) and Hospital Anxiety and Depression Scale (HADS). Participants were divided between the fatigue group (FACIT-F≤30) and the non-fatigue group (FACIT-F>30). For the statistical analysis, the primary outcome was the difference in the diffusing capacity of the lungs for carbon monoxide (DLCO) between groups. Considered secondary outcomes were differences in PFT, CPET, chest CT, hand grip, EQ-5D and HADS.

The fatigue group had 81 patients (25.7%) against 234 (74.3%). PFT and CPET showed no significant difference in DLCO and oxygen consumption peak values between groups. The fatigue group had a lower workload (mean 55.3±21.3 watts vs 66.5±23.2 watts, p=0.003), higher breathing reserve (median 41.9% (33.8–52.5) vs 37.7% (28.9–47.1), p=0.028) and lower prevalence of ground glass opacity (60.8% vs 77.7%, p=0.003) and reticulation (36.7% vs 54.9%, p=0.005) in chest CT. The fatigue group had higher anxiety (57% vs 24%, p

Fatigue in patients with PCC 6–12 months after hospitalisation is relatively common and had weak correlation with pulmonary disorders. Our results suggested fatigue could be strongly related with peripheral disorders such as reduced musculoskeletal strength or psychosocial limitations.