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HOTFy: randomised clinical trial for hyperbaric oxygen therapy in fibromyalgia

Background

Fibromyalgia is a polysymptomatic central sensitisation disorder characterised by widespread pain, fatigue, sleep disturbances and neuropsychiatric features. Hyperbaric oxygen therapy modulates neuroinflammation, mitochondrial function and neuroplasticity, thereby yielding analgesic and functional benefits.

Objective

Evaluate the efficacy and optimal timing of hyperbaric oxygen therapy as an adjunct to standard care for fibromyalgia.

Design, setting and participants

This single-centre, randomised, cross-over group, assessor-blinded clinical trial was conducted in the Department of Rheumatology at the University Hospital of the Federal University of Juiz de Fora, Juiz de Fora, Brazil, and adhered to Consolidated Standards of Reporting Trials (CONSORT) guidelines. Women (18–70 years) with a diagnosis of fibromyalgia for ≥2 years were randomised 1:1 to early hyperbaric oxygen therapy plus standard care or standard care alone (delayed group). Intention-to-treat (ITT) analysis was conducted with all 56 participants (mean age: 51.0±9.8 years; mean body mass index: 30.5±5.1 kg/m²).

Interventions

Standardised care (education, exercise and pharmacotherapy) plus hyperbaric oxygen therapy was delivered at 2.3 atmospheres absolute for 90 min, five times per week, over 8 weeks (total 32–40 sessions). The early group received hyperbaric oxygen therapy during weeks 0–8, while the delayed group received it during weeks 8–16, following the same protocol.

Outcomes

Primary endpoints included the Fibromyalgia Impact Questionnaire-Brazilian Portuguese (FIQR-Br), the pain visual analogue scale (VAS) and the Symptoms Assessment Scale-40 (EAS-40) for psychopathology. Secondary endpoints included the 12-Item Short-Form Health Survey (SF-12) physical and mental components and adverse effects. Assessments were conducted at baseline, 8 weeks and 16 weeks, and analysed using a mixed-design 2x3 analysis of variance (group: early vs delayed; time: baseline, 8 weeks and 16 weeks) with Greenhouse-Geisser corrections as needed, followed by Bonferroni post hoc tests. Missing data were assessed using Little’s missing completely at random (MCAR), and considering the ITT analysis, the means imputed for missing data were estimated through expectation maximisation. Effect sizes were reported as partial ² and Cohen’s d with α=0.05.

Results

44 participants completed the study, and the overall withdrawal rate was 21.4% with no baseline between-group differences. Significant time effects were observed for all primary outcomes and the SF-12 outcome (pxtime interactions were significant for FIQR-Br, VAS, EAS-40 and SF-12 physical and mental (p≤0.02; interaction ² up to 0.23), indicating improvements during active hyperbaric oxygen therapy exposure. Compared with standard care alone over 8 weeks, combined treatment achieved greater gains: FIQR-Br, –31.1% vs –14.4%; VAS, –54.0% vs –33.5%; EAS-40, –28.4% vs –3.7%; SF-12 physical, +39.1% vs +14.8%; SF-12 mental, +57.4% vs +31.9%. Large within-group effect sizes were observed (eg, VAS d=2.5–2.7; FIQR-Br d=1.4–1.7). Efficacy was equivalent regardless of time started, and the benefits converged by the end of each hyperbaric oxygen therapy phase. After stopping hyperbaric oxygen therapy, the FIQR-Br and SF-12 mental component scores regressed towards standard care levels, whereas residual improvements persisted for up to 8 weeks in VAS, EAS-40 and SF-12 physical component scores. Adverse events were infrequent; one case of otalgia required extended management. Withdrawals were primarily due to non-compliance or intolerance to chamber confinement. No serious or unexpected safety concerns were reported.

Conclusions

Hyperbaric oxygen therapy, delivered under a standardised protocol, is an effective and well-tolerated adjunct to multimodal fibromyalgia care. Timing can be individualised: early initiation for rapid relief or stepped introduction after optimised usual care, with comparable overall efficacy. The durability of the benefit appears to be exposure dependent, and maintenance or booster schedules merit further evaluation.

Trial registration number

RBR-6prps8g.

Prevalence of dyslipidaemia and low-density lipoprotein cholesterol target attainment: a descriptive cross-sectional study among adults in the Western Province of Sri Lanka

Por: Katulanda · P. · Thevarajah · R. · Fernando · D. R. · Katulanda · G. · Wickramasinghe · V. P. · Wijewickrama · E.
Objectives

To assess the prevalence of dyslipidaemia and associated risk factors, and evaluate low-density lipoprotein cholesterol (LDL-C) target attainment among adults in the Western Province of Sri Lanka.

Design

Cross-sectional epidemiological study.

Setting

Western province, Sri Lanka.

Participants

Participants were recruited through a community-based survey of non-institutionalised adults aged ≥20 years residing in the Western Province for at least 1 year (n=1800), using multistage stratified random cluster sampling.

Primary outcome

Dyslipidaemia was defined according to the National Cholesterol Education Programme/Adult Treatment Panel III guidelines. Prevalence estimates are presented with 95% CIs. Multiple logistic regression results are reported as adjusted ORs with 95% CIs.

Secondary outcome

Cardiovascular risk in participants aged ≥40 years was assessed using the WHO laboratory-based cardiovascular disease (CVD) risk chart for South-East Asia. Achievement of LDL-C targets was evaluated according to the Sri Lankan guidelines on management for dyslipidaemia management.

Results

Data from 1333 subjects were analysed. Mean age was 49.8 (±14.9) years. The majority were females (63.6%). The age-sex standardised prevalence of any form of dyslipidaemia was 73.3% (95% CI 70.9% to 75.7%). Age standardised prevalence in females was 77.1% (95% CI 74.3% to 79.9) and males was 69.3% (95% CI 65.3% to 73.3%). The most prevalent type of dyslipidaemia was low high-density lipoprotein cholesterol (HDL-C) (46.6%, 95% CI 43.9% to 49.3%), followed by high LDL-C (32.5%, 95% CI 30.0% to 35.0%) and high triglycerides (21.7%, 95% CI 19.5% to 23.9%). Low HDL-C was positively associated with smoking (OR: 1.89, 95% CI 1.16 to 3.18) and inversely with male sex (OR: 0.29, 95% CI 19 to 0.45) and physical activity (OR: 0.71, 95% CI 0.51 to 0.99). Elevated LDL-C was associated with male sex (OR: 1.84, 95% CI 1.2 to 2.89), diabetes (OR: 5.34, 95% CI 3.53 to 8.08), and hypertension (OR: 1.62, 95% CI 1.18 to 2.23). Male sex (OR: 1.85, 95% CI 1.08 to 3.18), diabetes (OR: 1.9, 95% CI 1.4 to 2.58) and hypertension (OR: 1.81, 95% CI 1.12 to 2.91) were positively associated with elevated triglycerides, whereas urban sector (OR: 0.54, 95% CI 0.32 to 0.91) was protective. Physical activity (OR: 0.65, 95% CI 0.44 to 0.98) and male sex (OR: 0.52, 95% CI 0.31 to 0.89) inversely associated with any form of dyslipidaemia, whereas diabetes (OR: 7.08, 95% CI 3.99 to 12.55), hypertension (OR: 1.93, 95% CI 1.36 to 2.73), and body mass index (OR: 1.06, 95% CI 1.01 to 1.2) were positively associated. The majority of participants (66.6%) had a

Conclusions

Three-fourths of adults in Western Province, Sri Lanka had any form of dyslipidaemia, more common in females. Low HDL-C was the most frequent abnormality. Most participants aged above 40 years were at low cardiovascular risk, yet two-thirds failed to meet LDL-C targets. Non-communicable disease prevention in Sri Lanka should expand through population-wide strategies, including awareness campaigns, promoting self-monitoring, targeted education and surveillance to evaluate interventions.

Interventions to improve functionality among paediatric patients with oncological diagnosis: a systematic review and meta-analysis protocol

Por: Holanda · K. M. · Vivas Costa · J. · Pereira · W. M. G. · Barbosa · A. S. · Martinez-Silveira · M. · Garcia-Hermoso · A. · Guerra · P. H. · Bezerra · I. N. · Barbosa Filho · V.
Introduction

Cancer is the leading cause of death and morbidity among children and adolescents worldwide. Functionality-based interventions are relevant among children and adolescents with an oncological diagnosis, whence studies summarising evidence on this topic are needed. This systematic review will summarise evidence on the effect of interventions to improve functionality indicators among paediatric patients diagnosed with cancer.

Methods and analysis

This protocol will follow Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA)-Protocols reporting guidelines. The systematic review will be conducted according to the Cochrane Handbook and PRISMA 2020. Studies will be searched in MEDLINE (PubMed), Embase, Web of Science, CENTRAL, LILACS and PEDro. Additional searches will include Google Scholar, reference lists of included studies, relevant reviews and trial registries. Studies will be included if they implement a functionality-based intervention. They must evaluate effects among paediatric patients with an oncological diagnosis. Secondary outcomes will include health-related quality of life. There will be no limits to language or year of publication, and articles published in peer-reviewed journals will be accepted. Only randomised controlled trials will be included. Risk of bias will be assessed using the Cochrane Risk of Bias Tool 2. Two independent reviewers will select studies, extract data and assess risk of bias. A narrative synthesis and meta-analysis will be conducted if studies are clinically and methodologically homogeneous. Statistical heterogeneity will be assessed using Higgins’ inconsistency test (I²). Meta-analysis may estimate combined effects using random-effects and the inverse variance method. The R statistical software will be used. The certainty of evidence will be evaluated for each outcome using the Grading of Recommendations Assessment, Development and Evaluation system.

Ethics and dissemination

This study used data from previously published studies, thus waiving submission to an Ethics Committee. Scientific dissemination strategies will include publication in peer-reviewed journals, conference presentations and workshops for the public.

PROSPERO registration number

CRD42024462833.

Application of process mining in healthcare logistics: a systematic literature review protocol

Por: Murazzano · L. · Landa · P. · Ghafourian Nasiri · M. · Bergeron · F. · Cote · A.
Introduction

Healthcare logistics involves the coordination of resources, services and infrastructure to ensure timely and efficient care delivery. Process mining offers data-driven insights into logistical workflows such as patient transport, inventory management and scheduling. This systematic review aims to synthesise evidence on the application of process mining in healthcare logistics, focusing on its impact on operational efficiency, resource utilisation and service delivery.

Methods and analysis

A systematic search will be conducted in MEDLINE, Embase, Google Scholar, Web of Science and ABI/Inform for studies published from 1999 onward. Eligible studies will include observational studies, case reports, conference papers and meta-analyses focusing on process mining applications to logistical processes in healthcare settings. Studies screening, data extraction and methodological quality assessment will be conducted using the Mixed Methods Appraisal Tool. Data will be extracted on key dimensions and performance indicators and will be presented in a structured format. A narrative synthesis will be conducted, and findings will be categorised and thematically analysed where appropriate. Primary outcomes include improvements in logistical efficiency, traceability, resource utilisation and sustainability. Secondary outcomes include implementation challenges, data integration issues and limitations in applying process mining techniques to logistical workflows.

Ethics and dissemination

The results of the systematic review will be disseminated via publication in a peer-reviewed journal and presented at a relevant conference. The data we will use do not include individual patient data, so ethical approval is not required.

PROSPERO registration number

CRD420251164812.

High flow oxygen for vaso-occlusive crisis: a multicentre, prospective, randomised, multi-arm, multi-stage clinical trial (OSONE)

Por: Mekontso Dessap · A. · Habibi · A. · Guillaud · C. · Kassasseya · C. · Larrat · C. · Agbakou · M. · Tchoubou · T. · Candille · C. · Carpentier · B. · Landais · M. · Arlet · J.-B. · Fartoukh · M. · Desclaux · A. · Masseau · A. · Oziel · J. · Bouharaoua · S. · Affo · C. · Viglino · D. · Bouk
Introduction

Sickle cell disease (SCD) is due to the mutation of haemoglobin (Hb), from HbA to HbS and characterised by recurrent vaso-occlusive crises (VOC), which can progress to acute chest syndrome (ACS), a leading cause of death in adults with SCD. Hypoxia is a key modifiable factor in the polymerisation of HbS and the pathogenesis of VOC. High-flow nasal oxygen (HFNO) delivers humidified gas at high oxygen concentrations and flow rates: the former may reverse sickling (metabolic effect) to accelerate VOC resolution and prevent ACS, while the latter may reduce the risk of ACS by mitigating hypercapnia and generating positive airway pressure that limits hypoventilation and atelectasis (pulmonary effect). The study hypothesises that HFNO is a safe and effective strategy for treating VOC and preventing secondary ACS, and will assess this using a multi-arm multi-stage (MAMS) trial design.

Methods and analysis

This is a prospective, multicentre, randomised, open-label controlled trial following an MAMS design with three phases and four arms: one control (low-flow oxygen) and three HFNO intervention arms with varying fraction of inspired oxygen levels (low, intermediate, high). The pilot stage will assess safety and feasibility, using the rate of cardiac and neurological events as the primary endpoint. In the activity stage, arms demonstrating acceptable safety will be compared for efficacy based on the rate of VOC resolution without complications by day 5, allowing selection of the most promising arm. The final efficacy stage will compare the selected HFNO strategy to control, with prevention of secondary ACS by day 14 as the primary endpoint. The study aims to enrol up to 350 VOC episodes in total.

Ethics and dissemination

The study has been granted ethical approval (CPP SUD MEDITERRANEE IV). Following the provision of informed consent, patients will be included in the study. The results will be submitted for publication in peer-reviewed journals.

Trial registration number

NCT03976180.

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