This study aimed to describe the epidemiology, outcomes and costs of four immune-mediated inflammatory rheumatic diseases (IMIRDs)—systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS)—in Brazil’s public and private healthcare systems from 2018 to 2022.

Retrospective observational study.

The study was conducted across hospital and outpatient levels of care in Brazil, based on nationwide data representing the public (Department of Informatics of the Unified Health System—DATASUS) and private (National Supplementary Health Agency—ANS) healthcare sectors.

The study analysed data from four distinct systems: 609 427 patients from the public Outpatient Information System (SIA), 32 119 patients from the public Hospital Information System (SIH), 19 083 deaths from the public Mortality Information System (SIM) and 11 846 hospitalisations from the private healthcare system (ANS).

RA had the highest incidence, ranging from 19.9 to 24.9 per 100 000, while SLE remained stable (6.3–6.7 per 100 000). Prevalence increased for all diseases: RA rose from 95.7 to 136.8, SLE from 23.4 to 38.9, AS from 15.0 to 23.6 and PsA from 10.8 to 17.4 per 100 000. SLE had the highest hospitalisation (7.2%) and lethality rates (8.7%), along with the highest average outpatient cost (US$440.9 per patient). In the private system, RA and SLE accounted for the most hospitalisations (36.3% each). SLE had the highest proportion of emergency hospitalisations (70.5%), while PsA had the highest proportion of elective hospitalisations (61.8%).

RA had the highest prevalence and incidence rates among the studied IMIRDs, while SLE was associated with the highest lethality, outpatient costs and emergency hospitalisations. The rising prevalence of these diseases highlights their growing burden on Brazil’s healthcare systems.

NCT06698900.

Individuals with Down syndrome (DS) are predisposed to obstructive sleep apnoea (OSA) due to craniofacial features (eg, midface hypoplasia, glossoptosis) and studies have shown that the prevalence of OSA in this population is markedly increased compared with that of typically developing children. Adenotonsillectomy is considered the first-line treatment for childhood OSA. However, persistent OSA is common, thus many children with DS are referred for positive airway pressure (PAP) therapy initiation; PAP appears to be an important aspect of living with DS. PAP has been shown to be highly effective in the general population for treating OSA and improving OSA-associated neurobehavioural symptoms, such as quality of life, behaviour, mood, daytime sleepiness and school performance. However, PAP as a treatment for OSA has not been well-studied in children with DS. Therefore, we designed a multicentre randomised controlled trial recruiting children with DS and OSA at three academic institutions, aged 6–18 years, referred for PAP initiation to treat OSA.

86 participants will be randomised to a 6-month intensive behavioural intervention (INT) to improve PAP adherence versus standard clinical care and underwent standardised evaluations of quality of life, behaviour, attention, PAP adherence and healthcare utilisation at baseline, 6 months and 12 months.

This study has been approved by the institutional review board at Children’s Hospital of Philadelphia (IRB of record, IRB # 20–0 17 512). Cincinnati Children’s Medical Center and University of Miami delegated IRB review and approval responsibility to Children’s Hospital of Philadelphia through reliance agreements as mandated by National Institutes of Health (NIH). All participants will be minors; consent will be obtained from parents and assent from participants will be obtained when possible. The intervention tested in this trial is considered not greater than minimal risk, and no identifiable data will be reported. As required by the NIH, a data safety monitoring board (DSMB) has been formed, who will review and approve the protocol and any protocol changes prior to implementation. The study team will send biannual reports and hold a biannual meeting with the DSMB to review any safety and protocol concerns. Findings will be presented at national conferences pertinent to this topic and published in peer-reviewed medical journals. In addition, findings will be shared in the lay format with DS associations around the world and used for training of healthcare providers and trainees (R25HD118212). Further, data collected will be deposited in a repository (National Sleep Research Resource; sleepdata.org) after completion of the study to maximise use by scientific community.

NCT04132999.

Patients with fragility fractures are two times as likely to suffer future fractures as their peers who have not suffered a fracture. In addition, 40% of those who suffer fragility fractures do not recover their level of functioning in terms of activities of daily living after 1 year. The present study aims to verify the hypothesis that a semipersonalised home-based exercise intervention may improve patients’ independence and reduce the number of hospital admissions compared with usual care for a population that suffers fragility fractures.

This parallel-arm single-blinded randomised-controlled trial will take place at the University of Cordoba (Spain) between September 2022 and September 2024. Patients aged >50 years old who have undergone surgery for a fragility hip fracture and who were prefracture independent (Barthel index (BI)>60) will be invited to participate. Patients will be excluded if they present a different type of fracture, mild or greater cognitive impairment or contraindication to exercise training. Patients will then be randomised into exercise or usual care group. The former will receive a daily walking appointment (number of steps to be completed inside home, interspersed with sit-to-stand movements) with the total volume increasing weekly. The latter will receive the usual care. The outcomes, collected at baseline, at the end of training (3 months) and at follow-up (6 months) by blinded operators will include the BI and number of readmissions (primary outcomes) and quality of life, exercise capacity, strength, cognitive status, bone mineral density and laboratory biomarkers (secondary outcomes). Variables related to quality of life, cognitive status, laboratory markers and densitometry will also be analysed.

The research ethics committee of the province of Cordoba approved the project (number 326; date 28 July 2021). Patients who meet the eligibility criteria will receive a patient information document and the consent form and will be encouraged to ask any questions. The proposed research respects the fundamental principles of the Declaration of Helsinki, the Council of Europe Declaration on Human Rights and Biomedicine, the UNESCO Universal Declaration on the Human Genome and Human Rights, and the Oviedo Council on Human Rights and Biomedicine. The data obtained in this study will be confidential. They will be treated by the Organic Law 3/2018, of 5 December, on the Protection of Personal Data and Guarantee of Digital Rights, keeping it strictly confidential and not accessible to unauthorised third parties, and the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on Data Protection (RGPD). Written informed consent will be obtained from all the participants. The study’s results will be published in peer-reviewed journals and presented at scientific congresses worldwide. The results will also be disseminated through patient advocacy group newsletters and social media platforms. Patient partners will help select the appropriate channels and develop plain-language summaries tailored to their communities’ needs.

ClinicalTrials.gov ID: NCT04934358 (registration date: 14 June 2021).

Progress at the intersection of artificial intelligence and paediatric neuroimaging necessitates large, heterogeneous datasets to generate robust and generalisable models. Retrospective analysis of clinical brain MRI scans offers a promising avenue to augment prospective research datasets, leveraging the extensive repositories of scans routinely acquired by hospital systems in the course of clinical care. Here, we present a systematic protocol for identifying ‘scans with limited imaging pathology’ through machine-assisted manual review of radiology reports.

The protocol employs a standardised grading scheme developed with expert neuroradiologists and implemented by non-clinician graders. Categorising scans based on the presence or absence of significant pathology and image quality concerns facilitates the repurposing of clinical brain MRI data for brain research. Such an approach has the potential to harness vast clinical imaging archives—exemplified by over 250 000 brain MRIs at the Children’s Hospital of Philadelphia—to address demographic biases in research participation, to increase sample size and to improve replicability in neurodevelopmental imaging research. Ultimately, this protocol aims to enable scalable, reliable identification of clinical control brain MRIs, supporting large-scale, generalisable neuroimaging studies of typical brain development and neurogenetic conditions.

Studies using datasets generated from this protocol will be disseminated in peer-reviewed journals and at academic conferences.

Adolescence is a critical period marked by rapid brain development and the onset of many mental health disorders. Brain MRI studies during adolescence, especially when paired with behavioural phenotypes and information about genetic risk factors, hold promise to advance early identification of mental health risk and spur the creation of targeted treatments to improve patient function, prognosis and quality of life. However, prospective neuroimaging is costly and time-intensive, and individuals who participate may not be reflective of the general population. These challenges are compounded when examining adolescents, as many families lack the time, energy or resources to participate in studies that use research-grade imaging. Repurposing clinical MRIs obviates many of the challenges of neuroimaging research. Here, we describe the brain-behaviour-genetics study protocol. This protocol describes procedures used to recruit participants with recent high-quality clinical brain MRIs and prospectively acquire genetic and sociobehavioural data, resulting in a highly cost-efficient design that harnesses a vast and underused neuroscientific resource.

The brain-behaviour-genetics protocol aims to recruit 1000 adolescents who have clinical brain MRIs contained in Children’s Hospital of Philadelphia’s electronic health record. One or both parents of the adolescent proband will be recruited when possible. Parents and adolescents will complete a series of self-report scales spanning the domains of mental health, trauma, risk and resilience. Saliva samples will be collected from the adolescent and at least one biological parent, using an at-home saliva collection kit. Subsequent analysis will examine associations between brain development, genetics and behavioural measures in adolescence.

Approval for the study had been obtained from the Children’s Hospital of Philadelphia’s institutional review board (IRB #23–0 20 851). Results will be published in peer-reviewed journals.

Shared decision-making (SDM) requires that individuals are correctly and smoothly supported to make decisions. However, in Japan, development of decision aids (DAs) to support implementation of SDM is lagging behind Western countries, and there are few reports focused on breast reconstruction. Thus, it is unclear if SDM using a DA in the context of the unique national character and medical culture in Japan is useful in decision-making for breast reconstruction, including whether or not to undergo reconstruction. The aim of this multicentre collaborative study is to investigate the clinical effectiveness of SDM using a DA for patients with breast cancer considering reconstruction, from the perspectives of decisional conflict and postoperative quality of life.

A multisite trial will be conducted at 12 facilities certified by the Japanese Society of Breast Oncoplastic Surgery. A cluster-randomised controlled trial is planned at centres that have implemented SDM with DAs and those that have not implemented SDM, but use a conventional surgical explanation and informed consent to make decisions about reconstruction methods. The study participants will be female patients aged ≥20 years with newly diagnosed stage 0–III breast cancer who are interested in breast reconstruction. Data collection includes baseline and follow-up patient surveys and medical record review. The effectiveness of the DA at reducing conflict and regret in decision-making (primary outcome) will be evaluated using the decision conflict scale.

This protocol has been approved by the Kyoto University Central Institutional Review Board, and permission for performance of the study has been obtained from the Ethics Review Board at each participating centre. We plan to disseminate the findings through journal publications and national meetings, including a presentation of the research results at the Japanese Society of Breast Oncoplastic Surgery. Our findings will advance the science of medical decision-making and have the potential to reduce socioeconomic health disparities.

UMIN000052161.

Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective biomedical intervention for HIV prevention, but its access and utilisation are challenging, especially in high-burden settings such as Kenya. For potential PrEP users, long delays and repeated consultations with several providers are obstacles to both PrEP uptake and continuation. The One-Stop PrEP Care project aims to promote the use of PrEP among clients in the health system and enhance client satisfaction by reducing the waiting time.

We are conducting a 1:1 cluster-randomised trial to evaluate whether One-Stop PrEP Care achieves equivalent or better PrEP outcomes compared with the standard of care model in 12 high-volume HIV clinics in Kisumu County, Kenya. In the One-Stop model, all core PrEP components, including HIV risk evaluation, HIV testing and PrEP dispensing, are provided by one provider in a single consultation room. Programme data from ≥2400 new PrEP clients will be abstracted for 12 months each to obtain primary endpoints of PrEP initiation and continuation. Adherence will be assessed via blood drug level testing. A nested cohort of up to 300 PrEP clients will be enrolled and followed every 3 months to provide in-depth data on individual HIV prevention behaviour, risk perception and how they align PrEP use with perceived risk. We will also evaluate programme costs.

Ethical approval was obtained from the University of Washington Institutional Review Board (IRB) on 8 July 2022 (IRB ID: STUDY00015873) and the Kenya Medical Research Institute Scientific and Ethics Review Unit (SERU) with a letter dated 4 May 2023 (Ref: 4697). Project findings will be shared with stakeholders, including the Ministry of Health, County health officials and participants. Results will be disseminated through manuscripts, policy briefs and health meetings.

Plans for communicating important protocol modifications include timely notifications to all study team members and training on the changes, and updates to relevant stakeholders, including the two IRBs, through protocol amendment submissions.

V. 2.0 dated 21 May 2024.

NCT03194308.

The mental health of people living with HIV (PLWH) is a growing concern globally, particularly in sub-Saharan Africa (SSA), where there is limited access to mental healthcare, with evidence showing high levels of depression, anxiety and neurocognitive disorders among this population. While Mental Health Disorders (MHDs) can impede HIV care and promote adverse health outcomes, there is limited literature on MHDs among PLWH. This scoping review will explore the existing literature on the burden and factors associated with MHDs among adults living with HIV in SSA.

Arksey and O’Malley’s methodological framework will guide the search of this scoping review. Relevant original research articles published in English from 1 January 2000 to 31 May 2025 on MHDs among PLWH in SSA will be identified through searches in the African Index Medicus, African Journal Online, PubMed and Embase databases. Four independent reviewers, working in pairs (one reviewer and one verifier), will screen the titles, abstracts and later the full texts, adopting the population, concept and context framework. Other coauthors will serve as tiebreakers whenever there is disagreement on the eligibility. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews flowchart will be presented. We will perform a narrative synthesis to report our findings.

This scoping review protocol does not require ethical approval, as it relies solely on publicly available existing data and does not involve human participants. We will disseminate the findings from this review through peer-reviewed publications and presentations at local and international conferences.

The protocol was registered in the Open Science Framework (https://osf.io/8ymqu).

Persistent pain after finishing breast cancer treatment is a common and disabling problem. The current state-of-the-art pain management advocates, in addition to biomedical (non-)pharmacological approaches, a biopsychosocial rehabilitation approach to address persistent pain, combining pain science education with promoting an active lifestyle through self-regulation techniques. We propose testing an innovative eHealth self-management support programme for this purpose in the breast cancer population with persistent pain after finishing cancer treatment. This delivery mode is believed to reduce barriers to pain self-management by providing timely, safe and cost-effective assistance addressing the biopsychosocial needs of patients. Utilising a chatbot format, the eHealth programme delivers pain science education and promotes physical activity (PA), personalised through decision-tree-based algorithms to support pain self-management. The programme aims to empower patients with understanding, coping skills and self-management techniques to reduce pain-related disability and enhance participation in daily life. The primary objective is to determine programme effectiveness compared with (1) usual care (superiority) and (2) a similar face-to-face pain self-management support programme (non-inferiority).

A pragmatic, three-arm randomised controlled trial was started in April 2024 at the University Hospitals of Antwerp and Leuven and primary care settings in Belgium. Participants are breast cancer survivors with persistent pain after finishing cancer treatment. Two hundred seventy participants will be randomised to one of three trial arms: (1) eHealth self-management support programme, (2) usual care or (3) a face-to-face self-management support programme. The ‘eHealth self-management support programme’ begins with a pain science education (PSE) module to initially convey key pain-related concepts and provide personalised pain management tips. Then, the programme progresses to daily activity planning to promote an active lifestyle. Guided by the Health Action Process Approach (HAPA) model, participants set and review daily activity goals and track progress. The eHealth self-management programme uses a chatbot and is accessible on any digital device. The ‘usual care programme’ involves sending the participants a study-specific brochure by postal mail and does not include any formal PSE and/or PA programmes. They may pursue or continue self-initiated care. In Belgium, usual care primarily involves pharmacological treatment, general advice on PA and the provision of informational brochures. The ‘face-to-face self-management support programme’ mirrors the eHealth intervention, combining PSE with PA coaching. It starts with three individual sessions with a trained physical therapist for biopsychosocial assessment and PSE, followed by six sessions on goal setting and active lifestyle coaching. The educational content is delivered both verbally and in written form. The primary outcome will be pain-related disability 6 months after baseline assessment. As a key secondary outcome, the effect on pain beliefs and attitudes will be investigated after the educational part of the eHealth and face-to-face programme (ie, at 6 weeks after baseline). Other secondary outcomes related to other dimensions of pain and physical-, psychosocial- and health-economic outcomes will be assessed at 12 weeks and 6 and 12 months after baseline as well.

The study will be conducted in accordance with the Declaration of Helsinki (2024). The protocol has been approved by the ethical committee of the University Hospitals of Leuven and Antwerp. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses. Ethical Committee of the University Hospitals Leuven and Antwerp: BUN B3002023000132.

ClinicalTrials.gov Identifier: NCT06308029.

Gestational diabetes is a common metabolic disorder in pregnancy which identifies a substantial increased risk of future diabetes. Despite this risk, many individuals are not screened for dysglycaemia in the postpartum period. Continuous glucose monitoring (CGM) is an evolving technology that provides details of an individual’s glucose levels throughout the day; however, it has not yet been evaluated as a screening tool for postpartum dysglycaemia. To address this gap, this prospective cohort study will examine the use of CGM in the early postpartum period to predict the risk of maternal dysglycaemia after delivery.

The Predicting Dysglycaemia in Individuals with Gestational Diabetes Immediately Postpartum using CGM (PREDISPOSE) study is a prospective cohort study designed to assess the ability of a CGM device (Freestyle Libre 2) worn in the postpartum period to detect persistent dysglycaemia in individuals with gestational diabetes. The study will recruit 240 individuals with gestational diabetes. Each participant will wear the CGM immediately postpartum and before attending routine postpartum diabetes screening, consisting of a 75-gram oral glucose tolerance test (OGTT) and related blood work (haemoglobin A1c (HbA1c), complete blood count and lipid profile). The primary outcome is the accuracy of the area under the curve for all glucose measurements from the first CGM wear to detect postpartum dysglycaemia. We will perform sensitivity and specificity analyses to determine optimal CGM cut-offs to diagnose diabetes or prediabetes. Secondary outcomes include the incidence of postpartum dysglycaemia (based on 75-gram OGTT and/or HbA1c), incidence of postpartum dyslipidaemia, patient acceptability of CGM testing, data variability from CGM and cardiometabolic health outcomes diagnosed in years one, two and five after delivery.

All participating sites have received ethics approval of the current protocol and have started recruitment of participants to the study. The ethics boards that approved this study are the Biomedical Research Ethics Board at the University of Manitoba, the Conjoint Health Research Ethics Board at the University of Calgary, the Mount Sinai Hospital Research Ethics Board at Mount Sinai Hospital and the Comité d'éthique de la Recherche at Université Laval. Study results will be disseminated through conference presentations and publication in a peer-reviewed journal, regardless of study findings.

NCT04972955. Registration date: 28 June 2021.

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.