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Intermittent fasting and chronic pain: Protocol for a systematic review of randomised controlled trials

Por: Bruton · A. M. · Staab · C. · Gray · O. · Chua · W. R. · Alsakhita · N. · Goldenberg · J. · Roberts · J. L.
Introduction

Chronic pain is a leading public health problem, impacting over 1.5 billion people worldwide. Standard-of-care includes pharmaceutical medication, surgery and physical therapy, yet many patients experience continued symptoms. Investigation into lifestyle-based approaches such as dietary interventions has increased in recent years, including intermittent fasting, due to known impacts on inflammation and neurotransmitters.

Methods and analysis

This systematic review and meta-analysis will be conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The literature search will include the PubMed/MEDLINE, Embase (Ovid), Web of Science (Core Collection) and LILACS (VHL) databases. The Google Scholar, ClinicalTrials.gov, PROSPERO, Open Science Forum and MedRXiv platforms will also be searched. Randomised, controlled trials investigating the impact of intermittent fasting interventions in adult humans with any chronic pain condition will be included. The primary outcomes will be self-reported pain or function and the secondary outcome will be rescue medication use. Study screening, data extraction and risk of bias assessment will be conducted independently in duplicate. The Cochrane Risk of Bias-2 tool will be used to assess bias at the study level, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidelines will be used to assess bias at the outcome level. The meta-analysis will use random effects, with heterogeneity assessed using the I2 statistic. For studies that report rescue medication use, we will analyse the impact of intermittent fasting on pain or function, adjusting for rescue medication use, using established methods. Subgroup and sensitivity analyses will be conducted to explore heterogeneity.

Ethics and dissemination

As this project involves analysis of publicly available data, no ethical oversight was or is required. The results of this review will be disseminated by publication in a peer-reviewed journal.

PROSPERO registration number

CRD #420261395061.

Efficacy and safety of mycophenolate mofetil in preventing relapse of IgG4-related disease with re-elevation of serum IgG4 level during maintenance therapy: a protocol for a multicentre, randomised, double-blind, placebo-controlled study in China

Por: Zhang · J. · Nie · Y. · Peng · L. · Fei · Y. · Liu · Y. · Dong · L. · Kong · X. · Fu · M. · Zhang · X. · Liu · C. · Chen · Y. · Li · M. · Zhou · J. · Zhang · W.
Introduction

IgG4-related disease is a chronic fibroinflammatory disease with multiorgan involvement. Glucocorticoids and/or immunosuppressants as well as rituximab are both first-line treatments in remission induction therapy. However, relapse is common during the maintenance period, particularly in patients with re-elevation of serum IgG4 level. This study aims to evaluate whether adding mycophenolate mofetil (MMF) during the maintenance phase for such patients can reduce the risk of disease flare.

Methods

This study is a multicentre, randomised, double-blind, placebo-controlled study. A total of 108 eligible patients with re-elevation of serum IgG4 level during maintenance therapy will be included in this study and randomised in a 1:1 ratio to receive add-on MMF 0.5 g one time per day or placebo for 52 weeks. The primary outcome is the proportion of patients experiencing relapse at week 52. Secondary outcomes include time-to-relapse, changes in disease activity and serum IgG4 level, stratified relapse rate according to the elevation level of IgG4. Analyses will follow the intention-to-treat principle.

Ethics and dissemination

The study has been approved by the Ethics Committee of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences (approval no. K3231). Written informed consent will be obtained from all participants before enrolment. Findings will be disseminated through peer-reviewed journals and conference presentations.

Trial registration number

NCT05974683.

Antibacterial consumption in four paediatric inpatient facilities in Sri Lanka in 2023: a cross-sectional descriptive study

Objective

To describe antibacterial consumption (ABC) in four paediatric inpatient facilities in Sri Lanka in 2023.

Design

Descriptive cross-sectional study, adapted from the WHO Global Antimicrobial Resistance and Use Surveillance System methodology.

Settings

Paediatric inpatient facilities in two tertiary and two secondary care government hospitals located across three provinces.

Data

Data on antibacterials for systemic use, J01 in the Anatomical Therapeutic Chemical (ATC) classification issued to these paediatric inpatient facilities in 2023 by their respective hospital pharmacies.

Outcome measures

(1) ABC at ATC third and fifth levels expressed as defined daily doses (DDDs)/100 admissions, (2) ABC as per WHO ‘Access, Watch and Reserve’ category, (3) choice of antibacterials within a class, (4) DU 75% for oral and parenteral dosage forms, (5) quality indicators such as amoxicillin index and broad:narrow spectrum ratio.

Results

In 2023, total antibacterial (J01) consumption across the four paediatric inpatient facilities was 94.49 DDDs/100 admissions. Together, non-penicillin beta-lactams, penicillins and macrolides/lincosamides/streptogramins accounted for 90–98%. Co-amoxiclav was the most consumed antibacterial, and six agents (co-amoxiclav, cefotaxime, clarithromycin, azithromycin, cefuroxime and meropenem) collectively accounted for 70–90%. Aminoglycosides, tetracyclines, sulfonamides and trimethoprim, and quinolones contributed minimally. Access and Watch group antibacterials accounted for 34 and 65%. Quality indicators demonstrated disproportionately higher use of broad-spectrum and Watch group antibacterials.

Conclusion

High use of broad-spectrum and Watch-group antibacterials was observed across the four paediatric inpatient facilities. The findings highlight targets for antibacterial stewardship programmes and demonstrate the feasibility of ABC surveillance in Sri Lanka.

Timing of anticoagulation after emergency endovascular therapy for acute ischaemic stroke with atrial fibrillation (TIMERS): protocol for a randomised controlled trial

Por: Guo · Y. · Jia · X. · Liu · W. · Zhang · W. · Dong · X. · Meng · R. · Ma · H. · Cui · G. · Cheng · Y. · Yi · T. · Hao · J. · Jiang · Y. · Ji · X. · Feng · Y. · Wu · C.
Introduction

The optimal timing for direct oral anticoagulants (DOACs) initiation after acute ischaemic stroke in patients with atrial fibrillation (AF) remains unclear, particularly in those undergoing endovascular thrombectomy (EVT), who are at higher risk of both haemorrhagic transformation and early embolic recurrence. Patients undergoing thrombectomy have been under-represented in previous randomised trials, resulting in limited evidence for guiding management in this high-risk population. The TIMERS trial aims to evaluate the efficacy and safety of early versus delayed initiation of DOACs therapy after EVT in patients with large vessel occlusion stroke and AF.

Methods and analysis

This is a multicentre, prospective, randomised, open-label trial with a blinded outcome assessment. In total, 438 patients with acute ischaemic stroke and AF treated with EVT will be enrolled in this study. Patients will be randomised in a 1:1 ratio within 72 hours after stroke onset to early initiation (≤4 days) or delayed initiation (5–14 days). The primary outcome is a composite of recurrent ischaemic stroke, symptomatic intracranial haemorrhage or all-cause death within 90 days. Secondary outcomes include individual components of the primary endpoint, venous thromboembolism, systemic embolism, myocardial infarction, functional outcome (modified Rankin Scale), health-related quality of life (EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)) and major extracranial bleeding events.

Ethics and dissemination

The study is approved by the Ethics Committee of Xuanwu Hospital of Capital Medical University, the ethics approval document number is (2025)259-001. The trial findings will be disseminated through peer-reviewed publications and presentations at scientific conferences.

Trial registration number

NCT07139301.

[18F]AlF-FAPI-74 PET/CT for preoperative assessment of the peritoneal cancer index and comparison with MRI-based, surgical and pathological assessment in colorectal cancer patients eligible for CRS-HIPEC: study protocol for a prospective observational pro

Por: van den Bos · M. · Vogel · W. V. · van Duijvenvoorde · M. · Kok · N. F. M. · Aalbers · A. G. J. · Snaebjornsson · P. · Lacle · M. M. · Willemse · J. R. J. · Kool · W. · Hendrikx · J. J. M. A. · de Hingh · I. H. J. T. · van Grevenstein · W. M. U. · Boerma · D. · Milne · A. N. · van
Introduction

Colorectal cancer patients with peritoneal metastases have a very poor prognosis. A minority of these patients is eligible for curative cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The peritoneal cancer index (PCI) is an important criterion to select patients for CRS-HIPEC. Due to challenges in peritoneal metastasis detection by imaging, the PCI is currently routinely assessed by invasive diagnostic laparoscopy in addition to CT and/or MRI. Yet, open-close procedures and early disease recurrence following CRS-HIPEC are common, indicating the need for better patient selection tools. Fibroblast activation protein (FAP)-targeted imaging has recently emerged as a promising strategy for visualising peritoneal disease. The aim of this study is to assess the potential value of FAP inhibitor positron emission tomography/CT (FAPI-PET/CT) as an alternative non-invasive tool for quantitative PCI assessment.

Methods and analysis

TROMPET is a prospective observational proof-of-concept study. A total of 25 colorectal cancer patients with suspected or verified peritoneal metastases who are eligible for CRS-HIPEC based on MRI will be included in this study. Patients younger than 18, pregnant and/or breastfeeding, with any contraindication(s) for MRI, PET, CT and/or CRS-HIPEC, and/or with a known additional malignancy within the past five years are excluded. Participants will receive [18F]AlF-FAPI-74 PET/CT prior to surgery. The primary objective is to determine the correlation between PCI scores determined by FAPI-PET/CT and ‘true’ PCI scores determined by histopathological analysis of all resected lesions. The secondary objectives include the correlations between PCI scores determined by FAPI-PET/CT, by MRI and during surgery, the potential of FAPI-PET/CT to detect extraperitoneal metastases, and molecular and immunohistochemical analysis of resected tissue to provide insight into the nature of FAPI-PET-positive lesions. The primary endpoint is all PCI scores determined by FAPI-PET and histopathology and their correlation on patient level. If this study shows that the PCI score can be accurately determined preoperatively by FAPI-PET/CT, it will form the basis for further developing FAPI-PET/CT as a quantitative, standardised, non-invasive diagnostic tool for selecting patients for CRS-HIPEC. Moreover, the ‘radiology-pathology’ setup of the study will allow us to characterise FAPI-PET-positive and PET-negative lesions in detail, providing further insight into the strengths and potential pitfalls of FAPI-PET/CT in the detection of peritoneal metastases from colorectal cancer.

Ethics and dissemination

This study is approved by the assigned Medical-Research-Ethics-Committee (METC NedMec) on 19-08-2024. All participants will provide written informed consent. Study results will be disseminated through (inter)national meetings and peer-reviewed publications.

Trial registration number

2024-512301-16-01

Effect of intradialytic exercise on cardiovascular structural and functional parameters in maintenance haemodialysis: a systematic review and meta-analysis

Por: Xiao · Z. · Fu · C. · Li · W.
Objectives

To evaluate the impact of intradialytic exercise (IDE) on cardiovascular structural and functional parameters in patients receiving maintenance haemodialysis (MHD).

Design

A systematic review and meta-analysis.

Data sources

PubMed, Embase, Web of Science and the Cochrane Central Register of Controlled Trials were searched from inception through January 2026.

Eligibility criteria

Randomised controlled trials (RCTs) involving adults receiving MHD who underwent structured IDE versus usual care or non-exercise controls and reported cardiac, vascular or cardiorespiratory outcomes.

Data extraction and synthesis

Two independent reviewers performed literature screening, data extraction and outcome-level risk of bias assessment using the Cochrane Risk of Bias 2 (RoB 2) tool. Random-effects models were used to pool mean differences (MDs) and 95% CIs. Certainty of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE).

Results

Fourteen studies involving 934 participants were included. IDE increased left ventricular end-diastolic volume (3 studies, 213 participants; MD 14.15 mL, 95% CI 2.06 to 26.24; p=0.022), improved left ventricular ejection fraction (LVEF) (6 studies, 396 participants; MD 2.21%, 95% CI 0.28 to 4.15; p=0.025), reduced pulse wave velocity (PWV) (4 studies, 211 participants; MD –1.36 m/s, 95% CI –2.58 to –0.13; p=0.031) and increased peak oxygen uptake (Peak VO2) modestly (6 studies, 583 participants; MD 2.76 mL/kg/min, 95% CI 0.08 to 5.43; p=0.044). Diastolic blood pressure (DBP) was reduced (4 studies, 221 participants; MD –4.54 mm Hg, 95% CI –7.57 to –1.51; p=0.003). No significant differences were observed for left ventricular mass index (LVMI) (5 studies, 258 participants; MD –1.19 g/m², 95% CI –5.63 to 3.24; p=0.597) or systolic blood pressure (SBP) (4 studies, 221 participants; MD –8.76 mm Hg, 95% CI –20.38 to 2.86; p=0.139). Outcome-level risk-of-bias assessments predominantly showed some concerns, with high risk identified for individual contributing results. Heterogeneity was substantial for Peak VO2 (I²=90.07%) and SBP (I²=73.20%). Certainty of evidence was moderate for LVMI, LVEF, PWV and DBP and low for the remaining outcomes.

Conclusions

IDE may improve cardiovascular function, arterial stiffness and cardiorespiratory fitness in patients receiving MHD. Effects on LVMI and SBP remain uncertain. Certainty of evidence ranged from moderate to low, and risk-of-bias concerns and substantial heterogeneity for some outcomes warrant cautious interpretation.

PROSPERO registration number

CRD420261336421.

Effectiveness and cost-effectiveness of the Pain-at-Work Toolkit for improving work ability in adults with chronic pain: protocol for a cluster randomised controlled trial

Por: Blake · H. · Chaplin · W. J. · Abbott-Fleming · V. · Taylor · G. · McNamee · P. · Narayanasamy · M. · Thornton · A. · Walker-Bone · K. · Prior · Y.
Objectives

Chronic pain affects around 28 million adults in the UK and is associated with impaired work ability, reduced productivity and increased sickness absence. Access to work-focused support within healthcare services is limited, and most employers do not routinely provide structured assistance for employees living with chronic pain. The Pain-at-Work Toolkit is a co-created, web-based intervention designed to improve work ability, self-management, and workplace experiences for employees living with chronic pain. A feasibility trial demonstrated strong acceptability, exceptional recruitment and potential improvements in work ability, providing clear justification for progression to a fully powered evaluation. This paper describes the protocol for a definitive cluster randomised controlled trial to evaluate the effectiveness, cost-effectiveness and implementation of the Pain-at-Work Toolkit.

Methods and analysis

This two-arm, open-label cluster-randomised controlled trial will recruit at least 70 organisations (minimum 35 clusters per arm) and at least 685 participants. Organisations will be randomised 1:1 to (a) support-as-usual (SAU) or (b) SAU plus the Pain-at-Work Toolkit, and Pain-at-Work Manager’s Toolkit as an implementation-support component. The primary outcome is work ability at 3 months, measured using the Work Ability Index (three-item version). Secondary outcomes include work self-efficacy, sickness absence, presenteeism, productivity loss, job satisfaction, job stressfulness, turnover intentions, anxiety, depression and health-related quality of life. A mixed-methods process and implementation evaluation will assess fidelity, contextual influences and mechanisms of impact. A health economic evaluation will estimate cost-effectiveness from employer and societal perspectives. Analyses will follow intention-to-treat principles using multilevel modelling.

Ethics and dissemination

Ethical approval was granted by the University of Nottingham Faculty of Medicine and Health Sciences Research Ethics Committee (Ref: FMHS 1200226) and the UK Health Research Authority and Health and Care Wales (IRAS 367449). Findings will be disseminated through peer-reviewed publications, conference presentations, stakeholder reports and public summaries.

Trial registration number

NCT07600892.

Impact of PerioperAtive LidocAine Infusions on Enhanced Recovery After Noncardiac Surgery (IMPALA-ERAS) in an inpatient setting: rationale, design and protocol for a sequential, repeated crossover trial

Por: Rouleau · G. W. · Smith · A. W. · Parrish · C. G. · Allen · L. J. · Jayaram · J. E. · Ruble · S. R. · Adkins · C. M. · Eden · S. · Shotwell · M. S. · Yaghmour · E. T. · Statzer · N. J. · Wanderer · J. P. · Henson · C. P. · Shams · D. · Kertai · M. D. · Investigators · I. · IMPALA Inves
Introduction

Multimodal analgesic strategies designed to minimise perioperative opioid exposure are fundamental components of enhanced recovery after surgery (ERAS) pathways. Despite widespread implementation of ERAS protocols, the optimal analgesic regimen remains undefined, as the individual contributions of specific agents to overall analgesic efficacy and opioid-sparing effects are not fully elucidated. Intravenous lidocaine, a widely utilised local anaesthetic, possesses both analgesic and anti-inflammatory properties and has been associated with improved gastrointestinal recovery. This study seeks to pragmatically evaluate the impact of incorporating perioperative intravenous lidocaine infusion into established ERAS pathways on postoperative functional recovery.

Methods and analysis

The Impact of PerioperAtive LidocAine Infusions (IMPALA) on ERAS trial is a single-centre, pragmatic, cluster-randomised, double-blinded, placebo-controlled study. A total of 2290 patients undergoing elective colorectal surgery, emergency general surgery, urology, ventral hernia repair, surgical oncology or spine surgery will be randomly assigned to receive either intraoperative and postoperative intravenous lidocaine infusions (administered for up to 48 hours) or placebo as part of a standardised multimodal analgesic regimen integrated into established ERAS pathways. The primary outcome is case mix index–adjusted resource length of stay, defined as the time interval from surgical initiation to hospital discharge adjusted for case mix index. The primary outcome is total inpatient opioid consumption within the first 72 hours, reported in oral morphine milligram equivalents. Secondary outcomes include various in-hospital clinical endpoints derived from the electronic health record.

Ethics and dissemination

This protocol and accompanying statistical analysis plan outline the study design, primary and secondary endpoints and analytic methodology. The IMPALA-ERAS trial has received ethical approval from the Vanderbilt University Institutional Review Board (IRB: 250617). The findings will be disseminated via peer-reviewed publications and presentations at national conferences. Results from this trial are expected to inform evidence-based practices regarding perioperative lidocaine infusion and its potential contributions to enhanced postoperative recovery in surgical patients.

Trial registration number

NCT07224711.

Implementing and evaluating culturally relevant dance opportunities for people living with dementia in historically excluded and racialised communities: a qualitative case study protocol

Por: Kontos · P. · Bar · R. J. · Grigorovich · A. · Sethi · B. · Changfoot · N. · Skinner · M. W. · Herron · R. V. · Aleong · R. · Norris · M. · Colobong · R. · Kosurko · A. · Parr Vijinski · J. · Dubroqua · S. · Bhattacharya · N. · Ng · Y. · Iroanyah · N. · Jabouin · E. · Joseph · D.
Background

Engagement with the arts is advocated to reduce stigma and to increase the social inclusion of people living with dementia since the arts powerfully support non-verbal communication, affect and the opportunity to participate in activities that are meaningful to self and others. An example is Sharing Dance Older Adults (SDOA), an innovative, community dance programme that is offered by Canada’s National Ballet School (NBS) intended to support social inclusion by making dance accessible to older adults with a range of physical and cognitive abilities, including people living with dementia. Despite the benefits that SDOA offers people living with dementia and their carers, individuals from historically excluded populations, and more specifically those from racialised groups, have had only limited engagement with the programme. This study thus aims to co-develop with dance artists in the three largest racialised communities in Canada (Black, Chinese and South Asian) culturally relevant SDOA-informed dance opportunities for people living with dementia.

Methods and analysis

This 3-year study (2024–2027) is a multiple-case and intrinsic-case study design informed by critical participatory action research and the Critical Realism and the Arts Research Utilisation Model. For each of the three racialised communities, implementation and data collection will develop across five phases (preimplementation of professional development for dance artists; implementation of professional development for dance artists; postimplementation of professional development for dance artists; implementation of dance programming; and postimplementation of dance programming). Drawing on organisational partnerships in two Canadian provinces for three racialised communities, we plan to recruit older adults living with/without dementia who will attend the dance programming (n=90), formal/informal carers such as nurses and family (n=30), site managers such as directors of care (n=15), dance artists from the case communities (n=15) and NBS dance trainers who teach SDOA (n=2). Data collection strategies include: semistructured e-diary entries; active interviews; and video recordings of dance classes. All e-diary entries, transcriptions of interviews and video clips selected for full verbatim transcription will be analysed concurrently and recursively, using standard thematic analysis techniques.

Ethics and dissemination

All five phases of this study have been approved by the Clinical Trials Ontario (CTO Project ID: 4997, 11 June 2026), which is a streamlined ethics review system for multisite studies. All participants will provide written informed consent before taking part in the study. The outcomes will be shared through articles published in journals, presentations at academic and professional conferences, arts-based community events and other knowledge mobilisation forums that include all partners and collaborators.

All-cause mortality following internal fixation for isolated fractures in non-polytrauma admissions: a comprehensive 10-year nationwide linked data retrospective cohort study

Por: Muruet · W. · Hing · C. · Aylin · P. · Bottle · A. · Musbahi · O.
Introduction

Skeletal fractures are a leading cause of death and disability and a growing global public health concern. Internal fixation is a common surgical treatment indicated for several fractures, yet there are few comprehensive epidemiological studies describing mortality following the procedure.

Methods

Data were extracted from an England-wide administrative database (Hospital Episode Statistics, HES) and linked to mortality records from the Office for National Statistics (ONS). All records from patients aged 18 years or older who were admitted due to a non-polytrauma single fracture and underwent internal fixation between 2013 and 2023 were included. Crude and adjusted mortality rates were calculated as well as the restricted mean time lost.

Results

A total of 630 758 admissions were included in the primary analysis. Of these, 55% were female, and the mean±SD age was 59±23 years. Primary open reduction internal fixation was the most common procedure (54% of cases), followed by closed reduction internal fixation (35%). Overall, mortality rates following internal fixation were 2% within 30 days, 5% within 90 days and 10% within 365 days. Mortality rates were described by fracture region and reduction procedure. Variation in mortality rates across fracture regions and procedures was attenuated in the case-mix-adjusted estimates.

Conclusions

This study described national crude and adjusted mortality rates following internal fixation for the treatment of skeletal fractures. These findings provide population-level descriptive benchmarks for clinical and epidemiological interpretation and may inform decision-making by clinicians and patients as well as the design of randomised controlled trials and other research studies.

Optimised carbohydrate dietary intervention for improving metabolic health in adults with prediabetes: study protocol for a multicentre randomised controlled trial

Por: Zhang · R. · Lu · Y. · Zhang · N. · Liu · D. · Wu · Q. · Guo · J. · Zhao · H. · Li · Q. · Yang · J. · Pang · Y. · Zhang · Y. · Kang · P. · Wang · Q. · Zheng · Q. · Liu · S. · Mao · H. · Long · X. · Gao · X. · Zeng · R. · Zhang · M. · Fang · Q. · Jia · W. · Ni · Y. · Li · H.
Introduction

Dietary modification is an important strategy for the prevention of type 2 diabetes, with fibre intake recognised as a key factor in promoting metabolic health. Resistant starch (RS), a type of fermentable dietary fibre, has emerged as a promising therapeutic approach due to its association with weight loss, enhanced insulin sensitivity and improved glucose metabolism. As nutritional research progresses, the focus has shifted from individual nutrients to overall dietary patterns. Based on this concept, this study aims to investigate the metabolic effects of a dietary pattern that optimises carbohydrate structure by increasing RS intake and reducing rapidly digestible carbohydrate in adults with pre-diabetes.

Methods and analysis

This is a multicentre, randomised, parallel-controlled clinical trial, which will enrol 250 adults diagnosed with pre-diabetes. Eligible participants will undergo randomisation to receive either a guideline-based conventional diet or an optimised carbohydrate diet (OCD). In the OCD intervention, daily RS intake will be increased to approximately 40 g, with fibre intake rising to 20–40 g per 1000 kcal. At the same time, the intake of rapidly digestible starch and free sugars will be reduced. The intervention will last for 6 months, followed by a 3-month post-intervention follow-up period. The primary outcome is the change in postprandial glycaemic response, assessed using the incremental area under the curve (iAUC) for plasma glucose during the oral glucose tolerance test (OGTT). Secondary outcomes include the proportion of participants achieving remission to normoglycaemia or progressing to type 2 diabetes, changes in other glucose- and lipid-related metabolic parameters and changes in lifestyle-related behavioural factors. Exploratory outcomes will include changes in appetite-related hormones, circulating cytokines, immune function and multi-omics profiles.

Ethics and dissemination

This study was approved by the Ethics Committee of Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Approval No. 2025-122; Protocol V.1.0, 20250811) and the Ethics Committee of Shenzhen Center for Chronic Disease Control (Approval No. SZCCC-2024-011-01-PJ) and registered in the Chinese Clinical Trial Registry. Findings from this study will be disseminated in peer-reviewed journal publications.

Trial registration number

ChiCTR2500113583.

Sleep quality and psychological resilience: a cross-sectional study of community-dwelling adults in China

Por: Lee · E. · Chang · C. · Wu · Y.-H. · Hu · E. A. · Myers · A. · Delzell · E. · Kushida · C. · Lu · Y. · Shi · Y. · Huang · S. · Wang · P. · Zhu · S. · Hsing · A. W.
Objective

To examine the association between sleep quality and psychological resilience in a Chinese community-based cohort and assess the consistency of this association across two sleep measures.

Design

Cross-sectional analysis of baseline data.

Setting

Community-based cohort in Hangzhou, China (2016–2019).

Participants

10 268 adults aged 18–80 years enrolled via quota sampling stratified by sex and age group. After excluding participants with missing data, analytic samples were 9781 (single-item measure) and 9780 (Pittsburgh Sleep Quality Index (PSQI)), owing to one additional missing response.

Primary outcome measure

Low psychological resilience, defined by a median split on a 9-item scale adapted from the Brief Resilience Scale and Connor–Davidson Resilience Scale.

Results

Poor sleep quality was associated with higher odds of low resilience across both measures (single-item measure, adjusted OR=1.5, 95% CI 1.3 to 1.6; PSQI, adjusted OR=1.5, 95% CI 1.4 to 1.7), after adjustment for demographic factors, socio-economic factors, mental health indicators and health behaviours. Interaction tests showed no evidence of effect modification by sex, age group, loneliness or depression history for the single-item measure (p>0.05). For the PSQI, the association differed by loneliness (p<0.05), with a larger magnitude of association among lonely participants (adjusted OR=2.1, 95% CI 1.6 to 2.7) than non-lonely participants (adjusted OR=1.5, 95% CI 1.3 to 1.6).

Conclusions

Poor sleep quality was consistently associated with low resilience across both measures. Because the design was cross-sectional, temporal direction cannot be established. Longitudinal and interventional studies are needed to establish temporal ordering, and intervention studies are needed to determine whether improving sleep increases resilience.

Measuring and understanding geographic inequities in physician distribution in the Philippines: a multi-method study protocol

Por: Pepito · V. C. F. · Molen · R. G. C. · Migrino · J. R. · Capeding · T. P. J. Z. · Payumo · A. R. D. · Jeremias · H. I. M. · Ubial · K. R. · Tiu · W. C. · Dayrit · M. M.
Introduction

The Philippines faces physician shortages, exacerbated by their propensity to practise in urban centres. Despite government placement programmes, recruitment and retention of physicians in many areas throughout the country remain difficult. This study aims to: (1) describe the distribution of general physicians and board-certified specialist physicians and (2) identify the individual, work environment, local environment, national environment and international environment factors that may influence physicians to establish their practice in areas with below-optimal physician-to-population ratios in the Philippines.

Methods and analysis

To describe the distribution of general physicians and board-certified specialist physicians, we will map Philippine Health Insurance Corporation (PhilHealth)-accredited physicians at the regional and at the provincial level, superimposing medical schools and corresponding training institutions. To identify the individual, work environment, local environment, national environment and international environment factors that may influence physicians to establish their practice in areas of the Philippines with below optimal physician-to-population ratios, we will conduct three rounds of data collection: (1) an online survey of current Philippine Department of Health (DOH)-deployed physicians; (2) online or face-to-face focus group discussions and key informant interviews with a subset of DOH-deployed physicians, senior general and specialist physicians practising in Metro Manila and outside and DOH personnel involved in the implementation of these physician placement programmes at the national, regional and local level; and (3) a stated preference experiment administered to resident physicians of the specialties under study to determine which government interventions can encourage them to establish their practice in areas with lower than optimal physician-to-population ratios in the Philippines.

Ethics and dissemination

We have obtained ethics clearance from the Ateneo de Manila University School of Medicine and Public Health Research Ethics Committee. We will disseminate our findings in online or face-to-face dissemination sessions with the DOH, Philippine Health Insurance Corporation, Association of Philippine Medical Colleges, the Philippine Statistics Authority, the Professional Regulation Commission Board of Medicine, the Commission on Higher Education and partner specialty societies. We will also publish our results in peer-reviewed medical or public health journals.

Experiences of pregnant women staying in a maternity waiting home at Ari zone public health facilities, Ethiopia: a phenomenological qualitative study

Por: Minuta · W. M. · Gezume · A. · Wana · E. W. · Tesfaye · G. A. · Bolado · G. N.
Background

Maternity Waiting Homes (MWHs) are a key strategy for improving maternal health by bringing expectant women closer to health facilities and skilled birth attendants. Despite their potential benefits, a woman’s stay is shaped by various factors, including emotional, social and logistical aspects.

Objectives

This study aimed to explore the lived experiences of pregnant women using maternity waiting homes in the Ari zone public health facilities, Ethiopia.

Design

A qualitative phenomenological study, grounded in a descriptive (Husserlian) phenomenological orientation and analysed using Colaizzi’s seven-step framework.

Setting

Public health facilities providing MWH services in the Ari zone, southern Ethiopia, ranging from a zonal hospital to primary health centres.

Participants

15 pregnant women, who had stayed in an MWH for at least 1 week during their current pregnancy, selected using purposive sampling until data saturation was reached.

Methods

We conducted in-depth interviews from 15 June 2025 to 15 July 2025 to match the Study Area and Period section. The data were transcribed, translated and thematically analysed with Open Code software V.4.02 to identify key themes and subthemes. The rigour of the study was ensured by applying Guba’s trustworthiness criteria, with a focus on credibility, transferability, dependability and confirmability.

Results

Based on the findings, the experiences of women in maternity waiting homes centred on four main themes. Emotionally, women faced both isolation and anxiety from being away from home but also felt comfort and relief from being near medical care. Socially, they found support from other women and were influenced by the attitudes of health staff while also carrying the burden of family and cultural concerns. Practical challenges included significant financial burdens, lack of food and inadequate facilities. Despite these difficulties, women ultimately valued the homes for the increased confidence and improved access to skilled care they provided for a safer birth.

Conclusions

A woman’s experience in an MWH is shaped by a mix of emotional, social, infrastructural and cultural factors. To improve the use of MWHs and maternal health outcomes, it is crucial to enhance the quality of these facilities, offer psychosocial support and involve communities. Future intervention studies should test whether targeted psychosocial and food-security support measurably improve women’s experiences and MWH uptake.

Mental disorders, receipt of cardiac care following myocardial infarction and the impact of the COVID-19 pandemic: a cohort study

Por: Fleetwood · K. · Nolan · J. · Berry · C. · Cavers · D. · Mercer · S. W. · Padmanabhan · S. · Smith · D. J. · Stewart · R. · Vettini · A. · Jackson · C. A. · on behalf of the CVD-COVID-UK/COVID-IMPACT Consortium
Objectives

To compare receipt of guideline-informed myocardial infarction (MI) care by mental disorder and assess how the COVID-19 pandemic affected associations.

Design

A population-based cohort study using linked electronic health records.

Setting

England, November 2019 to February 2023.

Participants

131 075 adults with non-ST-elevation MI (NSTEMI) and 79 045 adults with ST-elevation MI (STEMI) were identified from the Myocardial Ischaemia National Audit Project, and their prior diagnoses of mental disorder were ascertained from linked hospitalisation and primary care records.

Outcome measures

We compared guideline-informed care standards for each of NSTEMI and STEMI between people with schizophrenia, bipolar disorder or depression versus those without any of these disorders. We used logistic regression to adjust for confounders and investigate differences over time.

Results

Mental disorder disparities were more evident for NSTEMI than STEMI. Following NSTEMI, people with a mental disorder had lower odds of angiography eligibility and receipt, cardiac ward admission and cardiac rehabilitation referral. ORs (95% CIs) ranged from 0.25 (0.20 to 0.31) for angiography receipt for schizophrenia to 0.92 (0.89 to 0.96) for cardiac ward admission for depression. Following STEMI, people with bipolar disorder were less likely to meet the 150 min call-to-balloon target (OR 0.72; 95% CI 0.55 to 0.93), and people with schizophrenia were less likely to receive rehabilitation referral (OR 0.38; 95% CI 0.23 to 0.61) or indicated secondary prevention medication (OR 0.46, 95% CI 0.27 to 0.77). There was no clear evidence that the COVID-19 pandemic affected disparities.

Conclusions

People with a mental disorder are less likely to receive guideline-informed MI care, with disparities greatest following NSTEMI and for people with schizophrenia.

Is home-based management feasible for COVID-19 patients requiring oxygen therapy? A participatory action study and cost analysis

Objectives

To explore feasibility and estimate cost of a home-based intervention for COVID-19 patients requiring oxygen therapy.

Design and setting

Participatory action study embedded in a regional collaborative healthcare network.

Participants

13 patients were included (77% female; mean age 68 years, SD 18.2).

Intervention

A previously designed intervention was piloted and iteratively evaluated in a multidisciplinary expert panel using a participatory action research approach.

Primary and secondary outcome measures

We scrutinised clinical course data and monitored adverse events. Feasibility was assessed using 12 key elements related to (1) communication, (2) logistics, (3) treatment and remote monitoring and (4) adverse events. In an explorative cost analysis, intervention costs were compared with hospital admission costs as the reference.

Results

Home-based management lasted for 7 days (SD 3.4) on average, with 4 days (SD 2.6) oxygen therapy. No intervention-related adverse events occurred. Main challenges were related to interprofessional communication, nursing care organisation and timely delivery of oxygen concentrators. Excluding costs for setting up the intervention, costs were estimated at 1124 per patient and this was mainly driven by costs on the first day. Compared with hospital admission, the cost-saving potential is estimated at 1087 to 2850 per patient.

Conclusions

An acute home-based care intervention embedded in a regional collaborative care network for patients with acute respiratory tract infections requiring oxygen therapy seems feasible and is potentially cost-saving.

Trial registration number

The Dutch Trial Register CCMO: NL77421.041.21; OMON Register: NL-OMON22655.

EQUITY-MS: evaluating the quality of investigation and treatment of multiple sclerosis using data from five specialist neurology centres in the UK--study protocol

Por: ONions · E. · Lewer · D. · Cheung · R. W. · Da Silva · E. · Das · J. · Dobson · R. · Keravica · R. · Moyo · F. · Rog · D. · Russell · M. · Spilker · C. · Tallantyre · E. · Ford · H. L.
Introduction

The social determinants of health are the conditions in which people live and the systems around them that shape these conditions. Social determinants of health may affect diagnosis and treatment for people with multiple sclerosis (MS) even in countries with universal healthcare systems. This study will investigate whether a person’s age, sex and/or gender, living in a more socioeconomically deprived area and being of a minoritised ethnicity impact access to a diagnosis of MS and disease-modifying treatments (DMTs) for people living in the catchments of specialist neurology centres with a total estimated catchment population of approximately 7 million people in England and Wales.

Methods and analysis

EQUITY-MS is a multicentre retrospective cohort study using routinely collected healthcare data. Study participants are people aged 16 and above who received a new diagnosis of MS between 1 January 2018 and 31 December 2024 while living within the catchment of five specialist neurology centres (located in Leeds, Bradford, Greater Manchester, Cardiff and East London). Data will be collected from patients’ hospital records by clinical teams. The primary outcome is the length of time between MS diagnosis and prescription of any DMT. Secondary outcomes are prescriptions of a high-efficacy DMT and the duration between patient-reported symptom onset and MS diagnosis. We plan to adjust for clinical and demographic factors that could impact prescribing decisions.

Ethics and dissemination

The study was approved by the North West–Greater Manchester East Research Ethics Committee (National Health Service) (25/NW/0184) on 14 August 2025. Results will be published in peer-reviewed journals, and summaries will be provided to local MS societies and disseminated via the study website (https://bradfordresearch.nhs.uk/bradford-centre-for-health-data-science/equity-ms/).

Effects of electronic patient-reported outcome monitoring on symptom burden and health-related quality of life in patients with metastatic breast cancer: a systematic review and meta-analysis protocol

Por: Xiong · H. · Luan · Q. · Li · W. · Tian · P. · Ning · J. · Han · Z.
Introduction

Metastatic breast cancer is increasingly managed as a long-term condition, yet symptom burden and health-related quality of life (HRQoL) remain major patient-centred concerns. Electronic patient-reported outcome (ePRO) monitoring has shown promise in improving symptom surveillance and supporting more responsive care in oncology; however, evidence specifically relating to metastatic breast cancer remains fragmented and has not yet been systematically synthesised. This review, therefore, aims to evaluate the effects of ePRO monitoring on symptom burden and HRQoL in patients with metastatic breast cancer.

Methods and analysis

This systematic review and meta-analysis will include randomised controlled trials and non-randomised controlled studies involving adults with metastatic breast cancer. Eligible interventions will include ongoing ePRO monitoring delivered through digital systems or platforms during treatment or follow-up. Comparators will include usual care or non-ePRO-based follow-up. The primary outcomes will be symptom burden and HRQoL; secondary outcomes will include physical, role and social functioning, individual symptom domains, healthcare utilisation, treatment adherence or interruption, patient satisfaction and feasibility indicators. A comprehensive search will be conducted in PubMed, Embase, Web of Science, CINAHL and the Cochrane Library from database inception to the final search date, with the planned literature search to be conducted from July 2026 to December 2026. Additional searches of ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform will also be undertaken. Two reviewers will independently perform study selection, data extraction and risk-of-bias assessment. Where studies are sufficiently comparable, meta-analysis will be conducted using random-effects models; otherwise, findings will be synthesised narratively.

Ethics and dissemination

Ethical approval is not required because this review will synthesise data from previously published studies and will not involve the collection of primary data from human participants. The findings will be disseminated through publication in a peer-reviewed journal and presentation at relevant academic conferences.

PROSPERO registration number

CRD420261383449.

Association between cataract surgery and diabetic retinopathy incidence and progression: an 11-year population-based retrospective cohort study

Por: Chang · Y.-C. · Wang · J.-H. · Chen · W.-T. · Chiu · C.-J.
Objectives

To evaluate the association between cataract surgery and the incidence and progression of diabetic retinopathy (DR) in a population-based cohort of patients with diabetes.

Design

A nationwide population-based retrospective cohort study.

Setting

A nationwide administrative claims database in Taiwan covering more than 99% of the population, with longitudinal follow-up from 2010 to 2021.

Participants

Adult patients (≥20 years) with diabetes mellitus and cataract were identified. Patients with prior cataract surgery before the first recorded cataract diagnosis were excluded. A total of 15 360 patients who underwent first-time cataract surgery and 15 846 patients without surgery were included. After two-stage matching (1:2 age-matching and sex-matching followed by 1:1 propensity score matching), 7837 matched pairs were analysed.

Interventions

Not applicable.

Primary and secondary outcome measures

The primary outcomes were (1) incident DR and (2) DR progression within 6 months and 1 year after the index date. Incident DR was defined as new-onset non-proliferative DR (NPDR) or proliferative DR (PDR). DR progression was defined as transition from no DR to NPDR/PDR or from NPDR to PDR. Outcomes were identified using diagnostic codes recorded at least twice in outpatient visits or once during hospitalisation.

Results

Cataract surgery was associated with higher risks of both incident DR and DR progression within 1 year. In the 1:2 matched cohort, the adjusted ORs were 3.40 (95% CI 2.65 to 4.36) for incident DR and 3.11 (95% CI 2.47 to 3.92) for DR progression. Similar findings were observed in the 1:1 propensity score-matched analysis. Absolute event rates at 1 year showed DR progression in approximately 3.1% of patients undergoing surgery compared with 1% in the non-surgical group. Increased risk was also associated with more intensive antidiabetic treatment.

Conclusion

Cataract surgery in patients with diabetes was associated with an increased risk of incident DR and disease progression, particularly within the first postoperative year. These findings support the consideration of cataract surgery as a clinically relevant risk window for enhanced retinal monitoring. Incorporating surgical history into DR risk stratification and screening strategies may improve early detection and inform postoperative care pathways.

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