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AnteayerBMJ Open

Megestrol acetate versus dexamethasone to prevent nausea and vomiting in patients with gastric or gastro-oesophageal junction cancer treated with oxaliplatin-based chemotherapy: study protocol of a multicentre, randomised, non-inferiority trial

Por: Luo · H. · Hu · Q. · Zeng · L. · Huang · Q. · Luo · Y. · Li · T. · Chen · P. · Yi · C. · Gou · H.
Introduction

Oxaliplatin is widely used in the treatment of gastric and gastro-oesophageal junction cancer. However, oxaliplatin-induced nausea and vomiting often complicate treatment and negatively affect patients’ quality of life. The current standard antiemetic regimen—dexamethasone (DEX) plus palonosetron—offers only limited efficacy, benefiting approximately 70% of patients, and is associated with steroid-related adverse effects, including insomnia and gastrointestinal bleeding. Consequently, there is a clear clinical need for effective DEX-free antiemetic regimens. This study aims to evaluate the efficacy and safety of megestrol acetate versus DEX in preventing oxaliplatin-induced nausea and vomiting in patients with gastric or gastro-oesophageal junction cancer.

Method and analysis

This is an investigator-led, multicentre, randomised-controlled, open-label, phase III, non-inferiority trial. Chemotherapy-naïve patients scheduled to receive oxaliplatin-based chemotherapy are randomly (1:1) assigned to receive either megestrol acetate (megestrol acetate group) or DEX (DEX group) in combination with palonosetron. The primary endpoint is the complete response (CR; no vomiting and no rescue therapy) rate during the first 120 hours following the initiation of chemotherapy (0–120 hours). Secondary endpoints include the following indicators: CR rate in acute period (0–24 hours), CR rate in delayed period (24–120 hours), time to treatment failure, frequency of salvage medication use, nausea, anorexia, adverse events and quality of life.

The study will evaluate the efficacy and safety of megestrol acetate compared with DEX for prevention of oxaliplatin-induced nausea and vomiting in patients with gastric or gastro-oesophageal junction cancer. If proven effective, the results might inform future antiemetic strategies in the long term to (1) provide a novel DEX-free antiemetic treatment for prevention of moderate-emetogenic chemotherapy, (2) reduce DEX-related adverse effects and improve quality of life in patients with gastric or gastro-oesophageal junction cancer and (3) support the potential incorporation of megestrol acetate into standard antiemetic medications.

Ethics and dissemination

The study protocol is conducted in accordance with the Declaration of Helsinki and approved by the Certified Review Board of West China Hospital, Sichuan University (Ethics Approval No 1116/2023). The results of this study will be disseminated via presentations at national and international scientific conferences and publication in peer-reviewed journals.

Trial registration number

ChiCTR2300075943.

Prospective cohort study of TIMP-1 and myocardial fibrosis in Chagas disease at a reference clinic in Pernambuco, Brazil: PTICH trial protocol

Por: Martins · S. M. · Macedo · C. T. · Meira · C. S. · Paim Santos · L. H. · Larocca · T. F. · Cavalcanti da Silva · F. F. · Leandro Lira · C. N. · da Silva · I. P. M. · De Araujo · L. T. · Soares · M. B. P.
Background

Chagas disease affects millions of individuals across Latin America and imposes a substantial economic burden on healthcare systems, particularly in rural and underserved regions. Chronic Chagasic cardiomyopathy remains one of the leading causes of heart failure-related mortality in endemic countries. Tissue inhibitor of metalloproteinases-1 (TIMP-1) has emerged as a potential biomarker of myocardial fibrosis in cardiomyopathies. This study was designed to investigate the association between TIMP-1 and myocardial fibrosis in chronic Chagas disease and to assess its potential as an early biomarker of fibrotic remodelling.

Methods and analysis

Bottom of form: The PTICH trial is a single-centre, prospective observational cohort study conducted at a government reference clinic in Pernambuco, Brazil. The study aims to enrol 210 adults with Chagas heart disease: 140 without ventricular dysfunction (left ventricular ejection fraction (LVEF) ≥52% in women and ≥54% in men) and 70 with ventricular dysfunction (LVEF

Ethics and dissemination

The Research Ethics Committee (REC) of Chagas disease and heart failure outpatient clinic—PROCAPE approved the PTICH trial (CAAE number: 65746322.8.1001.5192). Written informed consent has been obtained from all participants enrolled to date, and data handling is in compliance with applicable privacy and data protection regulations. Study findings will be disseminated through targeted outreach to civil society, the scientific community, healthcare professionals and Brazilian Unified Health System (SUS) policymakers; school-based science communication activities conducted in collaboration with state education departments (potentially including oral health educational materials); policy briefs and targeted reports for public health managers; technical meetings and institutional presentations; a plain-language summary published on the institutional website; and submissions to peer-reviewed journals and presentations at academic and health policy conferences.

Trial registration number

RBR-3dcrj98.

Trends and factors associated with previous induced abortions among young women in Foshan, China: insights from a retrospective cross-sectional study

Por: Ou · Y. · Chokkakula · S. · Chong · S. · Wang · H. · Liu · S. · Si · A. I.-C. · Pathakumari · B. · Lyu · J. · Yin · C. · Ye · X. · Huang · X.
Objectives

This study aims to explore the history of prior abortions and the factors influencing them among young women seeking abortion services in Foshan, Guangdong, China.

Design

This is a retrospective, cross-sectional study of young women seeking abortion care.

Setting

Gynaecological outpatient clinics at the Department of Gynaecology, Foshan Women and Children Hospital Affiliated to Guangdong Medical University, Foshan, Guangdong, China, between 2013 and 2023.

Participants

A total of 7361 young women aged 12–25 years seeking abortion services.

Measures

Data on abortion history, sociodemographic factors, contraceptive use and postabortion contraceptive choices were collected and analysed, with special emphasis on the incidence of repeat abortions and the factors associated with them.

Results

Of the 7361 participants, 34.2% reported at least one previous abortion, underscoring a notable public health concern. The mean age of the participants was 22.30 years (SD=2.13). Women with a history of abortion were significantly older than those without (22.57 vs 22.08 years, p

Conclusions

This study underscores the need for targeted interventions to address the multifaceted factors leading to repeat abortions among young women in China. The results offer valuable insights for improving reproductive health outcomes in this vulnerable population and highlight the importance of expanding access to contraceptive education and services in China.

Comparison of the identification and practicability of non-invasive diagnostic indicators under NAFLD, MAFLD and MASLD in China: a cross-sectional study

Por: Tan · X.-Y. · Zou · H.-H. · Huang · X. · Guo · M.-J. · Yu · R.-L. · Liu · X.-L. · Peng · T. · Yang · X. · Qin · C.-X.
Objectives

Early screening of non-alcoholic fatty liver disease (NAFLD) is critical for early diagnosis and management. The disease was renamed and its diagnostic criteria revised as metabolic-associated FLD (MAFLD) in 2020 and further updated to metabolic dysfunction-associated steatotic liver disease (MASLD) in 2023. This study evaluated the predictive performance and clinical feasibility of non-invasive diagnostic indicators across the NAFLD, MAFLD and MASLD diagnostic criteria.

Design

Cross-sectional study.

Setting

Health Management Centre in China.

Participants

A total of 5810 participants aged ≥18 years were enrolled. Individuals with missing laboratory data, imaging results or self-reported information were excluded.

Primary and secondary outcome measures

Disease-specific indicators included Fatty Liver Index (FLI), Hepatic Steatosis Index and Zhejiang University index (ZJU). Non-disease-specific indicators included lipid accumulation product (LAP), Visceral Adiposity Index and the Triglyceride and Glucose Index. Subgroup analysis was performed by gender and Body Mass Index (BMI).

Results

The area under the receiver operating characteristic curve (AUROC) for all six non-invasive indicators exceeded 0.7. FLI showed the optimal predictive performance across the three criteria (NAFLD-AUROC: 0.802, MAFLD-AUROC: 0.847 and MASLD-AUROC: 0.811), with comparable performance observed for ZJU (0.797, 0.838 and 0.809, respectively). Pairwise z-tests demonstrated a significant difference between FLI and ZJU for MAFLD (p0.05). Subgroup analyses revealed that ZJU performed better in males (NAFLD-AUROC: 0.790, MAFLD-AUROC: 0.839 and MASLD-AUROC: 0.803), while FLI was superior in females (NAFLD-AUROC: 0.832, MAFLD-AUROC: 0.838 and MASLD-AUROC: 0.838) and in participants who were overweight (NAFLD-AUROC: 0.709, MAFLD-AUROC: 0.765 and MASLD-AUROC: 0.709). LAP exhibited the highest predictive efficacy in the normal BMI subgroup (NAFLD-AUROC: 0.758, MAFLD-AUROC: 0.804 and MASLD-AUROC: 0.796).

Conclusions

FLI exhibited the highest predictive efficacy across all diagnostic criteria, and ZJU showed comparable performance. Considering diagnostic accuracy and clinical practicality, ZJU is recommended as a favourable, non-invasive tool for population-based screening in the Chinese population.

First population-based study on non-communicable diseases and risk factors in northeastern Iran: Sabzevar cohort profile

Por: Ghorat · F. · Chaman · R. · Javadinia · S. A. · Rad · M. · Mohammadzadeh · M. · Hassanpour · K. · Foroumandi · E. · Nazarzadeh · M. · Saghi · M. H. · Salari · M. · Bidel · Z. · Eghtesad · S. · Gohari · A. · Mohammadi · Z. · Borghabani · R. · Ghorbani · M. M. · Moslem · A. · Norouzi · S.
Purpose

Non-communicable diseases (NCDs) have become the leading cause of mortality globally, with a sharp rise in Iran due to lifestyle changes and urbanisation. Although many NCD risk factors are modifiable, limited understanding of their determinants hinders effective prevention. To address this, the Prospective Epidemiological Research Studies in Iran (PERSIAN) Cohort was established in 2014 to study NCDs nationwide. The Sabzevar PERSIAN Cohort Study (SPECS) is the first in northeastern Iran, aiming to investigate environmental and social factors influencing NCDs in a unique regional context.

Participants

SPECS enrolled 5174 adults (aged 35–70 years) in northeastern Iran between January 2018 and January 2019 through a census and an online registration process. The baseline data collection included demographic verification, informed consent, health questionnaires, anthropometric measurements and biological samples (blood, urine, hair, nails). The annual follow-up began in April 2019, with full reassessments every 5 years over a 15-year period. The data is gathered via an active and passive follow-up, supported by trained staff and registry linkages.

Findings to date

Of the 5174 participants, 4241 (81%) remained in the study. Among the cohort, 54.5% were female, with a mean age of 50.5 years. The majority were married (93.5%), and nearly half had at least high-school education (46.5%) and moderate socioeconomic status (49.4%). Drug abuse history (smoking/drugs) was reported by about 15% of the sample. The mean body mass index was 26.9 kg/m², and the average blood pressure was higher in males (118.1/74.0 mm Hg) than in females (111.5/70.2 mm Hg). The common conditions included hypertension (22.8%), kidney stones (22.4%), fatty liver (15.4%) and diabetes (13.8%). Cancer had the highest treatment rate (100%), while fatty liver had the lowest (70.1%). Stroke had the highest mean age of onset (51.2 years), and epilepsy the lowest (23.7 years). All health data were self-reported.

Future plans

SPECS, part of the national PERSIAN cohort initiative, is the only adult NCD-focused study in Khorasan Razavi. Its 15-year follow-up aims to generate region-specific insights into the incidence of NCDs and their risk factors. The ethnically homogeneous sample enhances statistical power, and the findings may inform culturally tailored health policies. While self-reported data have limitations due to bias, high initial participation and access to free healthcare support long-term engagement, especially among lower-income groups.

Multimorbidity patterns and their associations with healthcare services utilisation in inpatients with chronic hepatitis B infection from 2011 to 2023: a retrospective observational study

Por: Wang · X. · Xie · J. · Wu · Y. · Chen · G. · Ao · H. · Liu · Z. · Jie · Y. · Gu · J.
Background

Multimorbidity among patients with chronic hepatitis B (CHB) infection has emerged as a priority for healthcare and public health systems worldwide.

Objective

This study aimed to characterise time-trends in multimorbidities among patients with CHB infection. We identified multimorbidity clusters and combinations and quantified their associations with healthcare services utilisation.

Design

A retrospective observational study, using electronic medical record data.

Setting

A large tertiary general hospital in China.

Participants

The study included 23 137 patients with CHB infection admitted between 2011 and 2023.

Outcome measures

Latent class analysis and association rule mining (ARM) were performed to identify multimorbidity clusters and combinations, respectively. Multivariable logistic regression quantified associations between the identified multimorbidity patterns and length of stay (LOS), daily expense and 1-year readmission for liver-related conditions (OYRL).

Results

The mean number of multimorbidities among hospitalised patients with CHB infection was 2.82±1.89. From 2011 to 2023, mean age increased from 44.2±13.7 to 48.4±13.1 (p

Conclusions

Multimorbidity imposes a substantial burden on CHB-infected patients. Our findings highlight the importance of early diagnosis and treatment of CHB infection, as well as tailored integral strategies for multimorbidity management in individuals with CHB infection.

Evaluating a novel recovery device in diabetic patients with knee osteoarthritis: protocol for a randomised controlled trial

Por: Matourypour · P. · Akbari · A. · Zakerimoghadam · M. · Arjmandi · R. · Dehghan · A. H. · Zarei · M. · Parvizi · A. · Parvizi · A.
Introduction

Knee osteoarthritis (KOA) is a prevalent degenerative joint disorder, often accompanied by comorbidities like type 2 diabetes mellitus (T2DM). These conditions have a significant impact on patients’ sleep quality and metabolic health. Current treatments for KOA primarily focus on symptom management, while innovative approaches targeting interconnected health outcomes remain underexplored. The lumbar knee recovery device, a non-invasive device patented in Iran, offers potential benefits by enhancing lumbar-knee synchronisation, improving blood circulation and optimising cellular metabolism. This randomised controlled trial (RCT) aims to evaluate the device’s effectiveness in improving sleep quality and regulating blood glucose levels in diabetic patients with KOA.

Methods and analysis

This RCT aims to evaluate the impact of using the lumbar knee recovery device (Kamarasa) on sleep quality, blood glucose levels, HbA1c (blood glucose control level over the past 90 days) and body mass index (BMI) in patients with T2DM and grade 1–3 KOA. The study will be conducted at the Orthopedic Clinic of Imam Khomeini Hospital, Tehran, and the Health and Wellness Clinic. Eligible participants will be randomly allocated into two groups: the intervention group (receiving 10 supervised sessions using the Recovery device over 3 months) and the control group (receiving standard KOA and diabetes care). A total of 37 participants will be included in each group. The primary outcome, sleep quality, will be assessed using the Pittsburgh Sleep Quality Index at baseline and 3 months post intervention. Secondary outcomes will include random blood glucose levels, which will be measured at 10 intervals during the study; BMI, measured at the start and end of the study and HbA1c, assessed at both baseline and post intervention. The Western Ontario and McMaster Universities Arthritis Index will be used to assess pain, stiffness and physical function, also at both baseline and 3 months. Appropriate statistical tests, including two-sample t-tests, ² tests, analysis of covariance or linear regression, will be performed based on the type of variables using SPSS V.23. Additionally, standardised intervention effect sizes will be calculated for each outcome.

Ethics and dissemination

Ethical approval for this study was obtained from the Research Ethics Committee of the School of Nursing and Midwifery at Tehran University of Medical Sciences with reference number (IR.TUMS.FNM.REC.1403.145). Additionally, the study protocol was registered with the IRCT under the identifier IRCT20191027045257N7 on 24 November 2024.

Trial registration number

Iranian Registry of Clinical Trials (IRCT20191027045257N7). This clinical trial was registered on 24 November 2024.

Effectiveness of Virtual Baithak, an mHealth intervention to improve eye health literacy for the older adults in India: a protocol for a randomised controlled trial

Por: Rastogi · H. · Sarkar · D. · Rohilla · L. · Kumar · S. · Goyal · A. · Rana · G. S. · Singh · R. · Goyal · A. · Saini · S. K. · Gupta · V. · Pandav · S. · Duggal · M.
Introduction

Settings with insufficient human resources struggle to provide timely eye care services and information to the population. mHealth (mobile healthcare) is a promising solution; however, evidence on the effectiveness of interactive voice response (IVR) and real-time phone-based education remains scarce, despite their potential to be scalable and cost-effective. This study aims to implement the Virtual Baithak, an interactive mHealth platform, to improve eye-health literacy among older adults residing in rural India. The objectives are to (1) Develop and validate the Virtual Baithak for improving vision health and (2) Determine its effectiveness, feasibility and acceptability among the older adults.

Methods and analysis

This 3-armed, parallel, randomised controlled trial of 14 months duration will enrol 381 older adults (aged 60 years and above). Participants will be blinded and randomly (computer-generated) assigned to either of the three groups based on the intervention for eye-health education they receive: both IVR and group calls moderated by a healthcare professional, only IVR and usual care. The two intervention arms will receive the information weekly over a 3-month period through the Virtual Baithak platform, which will be designed for this study using a participatory research approach to develop the content. The primary study outcomes are digital health literacy and vision health knowledge scores, measured at baseline and 14 months. The secondary outcomes include m-health technology acceptance and usage practices. A mixed-method process evaluation will be conducted to assess the intervention feasibility and implementation, including in-depth interviews with participants. The qualitative data will be thematically analysed to explore factors that promote or restrain the implementation. The inferential statistical quantitative analysis will be performed using linear mixed models.

Ethics and dissemination

The study has been approved by the ‘Institute Ethics Committee,’ PGIMER, Chandigarh, India (PGI/IEC/2022/EIC000282 dated 18 February 2022). The results will be disseminated via presentations and/or publications at the national and international levels.

Trial registration number

CTRI/2023/02/049383, dated 1 February 2023.

PERSEVERE: longitudinal assessment of quality of life and treatment toxicities in Chinese breast cancer patients - a multicentre cohort study protocol

Por: Qu · Z. · Wang · H. · Li · Q. · Zhang · Y. · Li · K. · Pei · S. · Yang · Y. · Zhang · L. · Yang · X. · Wang · J. · Fang · Y.
Introduction

Survival outcomes for early-stage breast cancer have improved substantially; however, many survivors experience persistent treatment-related toxicities that adversely affect long-term quality of life (QoL) and functional recovery. Prospective survivorship data from China remain limited. The PERSEVERE study aims to characterise longitudinal trajectories of QoL and treatment-related toxicities among Chinese women treated for stage I–III breast cancer and to identify factors associated with suboptimal recovery.

Methods and analysis

PERSEVERE is a prospective, multicentre, observational cohort study enrolling approximately 3000 women with newly diagnosed stage I–III invasive breast cancer across cancer centres in China. Data are collected at baseline and serially for up to 5 years, including clinical variables, a validated suite of patient-reported outcome measures collected via a centralised REDCap electronic platform and baseline biospecimens. The primary outcome is the change in the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 global health status/QoL score from baseline to 12 months. Longitudinal and time-to-event analytical approaches appropriate for observational cohort studies will be applied, with exploratory analyses planned to investigate symptom trajectories and biological correlates.

Ethics and dissemination

The study protocol (ID: NCC25/629-5575) has been approved by the Independent Ethics Committee of the National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences. Written informed consent will be obtained from all participants. Study findings will be disseminated through peer-reviewed open-access publications and presentations at national and international conferences, with summaries shared with clinicians and patient advocacy groups.

Trial registration number

NCT07010939.

Experiences of internet addiction among junior college students in Taiwan: a qualitative descriptive phenomenological study

Por: Huang · I.-L. · Li · J.-B. · Chung · M.-h.
Objectives

This study explored the lived experiences of internet addiction among Taiwanese junior college students. Specifically, it examined their perceptions of addiction, experiences of excessive use and attempts to manage their online behaviours.

Design

A descriptive phenomenological approach involving one-on-one, semi-structured, in-depth interviews was employed. Data analysis was conducted using Giorgi’s phenomenological method assisted by NVivo V.12.

Setting

The interviewees were from a junior college with two campuses in northern Taiwan.

Participants

Purposive and snowball sampling of 15 junior college students. All participants met the criteria for internet addiction using the Chen Internet Addiction Scale.

Results

Three main themes and eight subthemes were identified: continuous provocation (childhood exposure and unexpected pandemic), continuous promotion (irresistible immersion and compensatory self-isolation) and continuous resistance (varied self-awareness, dilemmas, perceived insignificance and futility). This study also explored how junior college students with internet addiction repeatedly struggle to resist a seamless virtual world.

Conclusions

From the perspective of adolescents with internet addiction, early exposure to the internet, the boost of the pandemic, the growing demand, and negative beliefs and attitudes all contribute to the inability to overcome internet addiction. These findings offer valuable insights into the underlying mechanisms of internet addiction, providing mental health professionals with a deeper understanding and establishing a foundation for the development of future intervention strategies.

Health worker capacity-building interventions and quality of primary healthcare delivery in sub-Saharan Africa: a systematic review protocol

Por: Amu · H. · Dzadza · A. E. L. A. · Glover · R. M. · Akpene · D. A. · Tiah · J. A. Y. · Agula · C. · Bawah · A. A.
Background

Achieving high-quality primary healthcare (PHC) remains essential to improving health systems performance and advancing progress towards attainment of universal health coverage, particularly in sub-Saharan Africa (SSA), where gaps in service delivery persist. Capacity-building interventions, such as mentorship, in-service training and supportive supervision, have been widely employed to improve the quality of PHC delivery. The evidence base is, however, fragmented across diverse settings, intervention types and outcome measures. This systematic review will examine the evidence on how capacity-building interventions improve the quality of PHC services in SSA, with a focus on the domains of effectiveness, safety, people-centredness, timeliness, equity, integration and efficiency as propounded by the WHO.

Methods

We will conduct a systematic review using established evidence synthesis methods and report the findings in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines. Eligible studies will include peer-reviewed and grey literature published in English between 2000 and 2025, focusing on capacity-building interventions aimed at improving PHC quality in SSA. We will search databases including PubMed, Embase, Web of Science, Scopus, Google Scholar and the African Journals Online. Study selection will follow the Population (PHC providers), Exposure (capacity-building interventions) and Outcome (quality of PHC delivery across WHO domains) framework. Quality assessment will use the Mixed Methods Appraisal Tool (MMAT). Data will be narratively synthesised using Atlas.ti software.

Ethics and dissemination

Ethical approval is not required because there will be no collection of primary data. Only published studies/records available on peer-reviewed literature and grey sources will be included. Findings will be disseminated through a peer-reviewed journal, academic conferences and stakeholder platforms in SSA.

Registration

The protocol has been registered in PROSPERO (CRD420251131534) and reported according to PRISMA-P guidelines.

Interfaces between communication, education and health: a scoping review protocol

Introduction

The interfaces between the fields of communication, education and health have been indicated by international institutions such as the WHO and the European Centre for Disease Prevention and Control. However, hegemonic scientific practices supersede dialogue between the three fields, isolating their practices. This fragmenting tendency is observed in scientific literature, which has created gaps in the dialogue and articulation between communication, education and health. Although health promotion requires both communicative and educational practices, the epistemological, historical, political, cultural and socioeconomic aspects have also engendered tensions between the fields. Communication is often seen as a mere instrument for other practices, rather than a phenomenon that (re)produces meanings and power dynamics. In opposing the reductionist and instrumentalising perspectives of knowledge fields, the primary objective of the scoping review is to map the scientific evidence on the interfaces between communication and education in health to indicate a conceptual framework that articulates communication and education practices within the context of health.

Methods and analysis

A transdisciplinary team developed this protocol based on the 2024 Joanna Briggs Institute Manual for Evidence Synthesis. The procedures required to conduct the review were guided by the frameworks proposed by Arksey and O'Malley, Levac et al and Peters et al. The study eligibility criteria were established based on the Problem, Concept and Context outlined in the research questions. Primary and secondary studies will be retrieved from nine sources, covering both conventional and grey literature. These sources include Embase, ERIC, LILACS, PubMed/MEDLINE, ScienceDirect, Scopus, Web of Science, the Brazilian Digital Library of Theses and Dissertations, and the Networked Digital Library of Theses and Dissertations. A categorised form will be used for data collection and subsequent analysis. The reporting of the review findings will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.

Ethics and dissemination

The nature of the research and the use of secondary data sources do not require informed consent forms or approval from ethics committees in Brazil. The scientific findings from the review will be disseminated through peer-reviewed journals, academic conferences and other scientific communication channels.

Study registration

The protocol was registered on the Open Science Framework (OSF) and is available at https://doi.org/10.17605/OSF.IO/Z3CX7.

Analysis of the trajectory of sleep quality changes and influencing factors in maintenance haemodialysis patients in Xinjiang, China: a prospective longitudinal study

Por: Tan · H. · Li · L. · Zhang · Y. · Gao · J. · Lin · K.
Objectives

To analyse the trajectory of sleep quality changes and identify influencing factors among patients undergoing maintenance haemodialysis (MHD).

Design

Longitudinal study design.

Setting

The study was conducted in the nephrology departments of two tertiary hospitals in Urumqi, Xinjiang, China.

Participants

This study employed convenience sampling and completed follow-up assessments for 282 patients with MHD between December 2024 and August 2025.

Outcome measures

Data collection used a general information questionnaire, the Pittsburgh Sleep Quality Index and the Self-Rating Depression Scale. Sleep quality assessment timepoints included baseline (T1), 3 months (T2) and 6 months (T3). Latent class growth models were used to identify heterogeneous trajectories of sleep quality. Univariable and multivariable logistic regression analyses were used to determine independent predictors of sleep disorders trajectory categories.

Results

Among 282 MHD patients, latent class growth modelling identified four distinct sleep trajectories: ‘High-Slightly Increasing’ (C1, 24.5%), ‘Low-Slightly Increasing’ (C2, 29.4%), ‘High-Declining’ (C3, 27.7%) and ‘Moderate-Increasing’ (C4, 18.4%). Multivariable analysis showed that, compared with C2, baseline depression significantly increased the odds of belonging to C1 (OR=8.53, p

Conclusions

This study reveals four heterogeneous sleep trajectories in MHD patients, underscoring a dynamic view of sleep quality. Depression is an overarching risk factor for unfavourable trajectories, while pruritus and inflammation specifically predict persistent poor sleep. Early screening and targeted interventions against these factors are crucial to improve sleep quality in MHD care.

Strengthening and Targeted Rehabilitation for Optimal Neuromuscular Gains for chronic BACK pain (STRONG-BACK): protocol for a randomised controlled trial in participants with primary nociceptive pain drivers

Por: Fortin · M. · Rosenstein · B. · Bertrand · C. · Vaillancourt · N. · Wright · A. · Montpetit · C. · Macedo · L. · Elliott · J. · Cook · C. E. · Tousignant-Laflamme · Y. · Ma · J. · Page · M. G. · Dover · G. · Dang-Vu · T. T. · Weber · M. H.
Introduction

Exercise therapy is the most recommended treatment for chronic low back pain (LBP), with evidence supporting modest effects, likely due to the heterogeneity of patient presentations. Evidence suggests that matching individuals to the most appropriate exercise type could improve outcomes. Systematic reviews also emphasise that effective exercise interventions should be patient centred, target paraspinal muscle health and be of sufficient duration. This study addresses these gaps using a targeted care approach to identify a homogenous sample that is more likely to respond to our interventions. The inclusion of a sample with predominant nociceptive pain profile will be performed with the integration of the Pain and Disability Drivers Management Model (PDDM) and the Lumbar Spine Instability Questionnaire (LSIQ). The primary aim of this two-arm randomised controlled trial is to compare the effectiveness of motor control plus isolated lumbar extension exercises (MC+ILEX, arm 1) to free-weight resistance training (arm 2) in reducing LBP-related disability. Secondary aims include examining whether changes in multifidus composition mediate disability improvements comparing intervention effects on muscle size and quality, strength, mobility, pain, quality of life, sleep, physical activity and satisfaction; exploring baseline LSIQ scores and sex/gender as moderators of treatment response; and investigating participants’ perceptions and experiences of exercise therapy.

Methods and analysis

A total of 106 participants will be recruited through primary and secondary care and randomised (1:1) to receive either MC+ILEX or free-weight resistance training. Both groups will complete 48 exercise sessions over 16 weeks. The primary outcome will be disability at 16 weeks, measured by the Oswestry Disability Index. Secondary outcomes include multifidus muscle composition and size, lumbar and gluteal muscle strength, hip range of motion, pain, physical and mental function, satisfaction and recovery, health-related quality of life, sleep quality and physical activity levels. Linear mixed-effects models will be used to assess primary and secondary outcomes. Regression analyses will explore whether baseline LSIQ scores moderate treatment effects on multifidus composition and other outcomes. A subsample of participants will undergo semistructured interviews before and after the intervention to explore their illness perceptions, illness mindsets, perceptions of exercise therapy, as well as their experiences and satisfaction with the two exercise interventions. Reflexive thematic analysis will be used to analyse qualitative data.

Ethics and dissemination

This study received ethics approval from the Central Ethics Research Committee of the Quebec Minister of Health and Social Services (CCER-25-26-14). Results will be submitted to peer-reviewed journals and scientific meetings.

Trial registration number

ISRCTN14864451.

Effect of home-based walking exercise and education on early functional recovery after lung cancer surgery: protocol for the WalkLung multicentre randomised controlled trial

Por: Zhang · Y. · Liu · X. · Shi · X. · Feng · P. · Chen · Y. · Lei · C. · Zeng · H. · Li · T. · Gui · P. · Li · M. · Wang · L. · Zhang · R. · He · Y. · Chen · Y. · Chen · D. · Zhang · Y. · Liao · J. · Wei · X. · Tian · B. · Liu · X. · Li · Q. · Shi · Q. · Chen · X. · Dai · W.
Introduction

Walking, as a simple, low-cost and easily implemented form of exercise, offers multiple health advantages. The WalkLung trial aims to evaluate the efficacy of a home-based walking exercise and education intervention in promoting early functional recovery after lung cancer surgery.

Methods and analysis

WalkLung is a multicentre, parallel-group, randomised controlled trial conducted at three hospitals in China, with stratification by study centre. A total of 116 patients with postoperative lung cancer will be randomised in a 1:1 ratio to either the intervention group (home-based walking exercise and education for 4 weeks) or the control group (usual care). The primary outcome is the longitudinal walking difficulty score during the 4-week postdischarge, measured by the validated perioperative symptom assessment for lung surgery scale (0–10 scale), assessed at discharge and weekly for 4 weeks. Secondary outcomes are the 6-min walk test, pulmonary function, complications, physical activity level, quality of life, social functioning, exercise adherence and adverse events. Long-term outcomes (up to 6 months) will be analysed and reported separately. All analyses will use an intention-to-treat approach, with outcome measures analysed as appropriate using generalised estimating equations for repeated measures, and t-tests or 2 tests.

Ethics and dissemination

Ethical approval was obtained from the Ethics Committee for Medical Research and New Medical Technology of Sichuan Cancer Hospital (No. SCCHEC-02-2025-091) and all participating subcentres. Written informed consent will be obtained from all participants. The manuscript is based on protocol V.1.0 (2 January 2025). The study findings will be disseminated through peer-reviewed journal publications and conference presentations.

Trial registration number

ChiCTR2500103081.

Bayesian randomised controlled trial of guided parent-delivered cognitive behavioural therapy for children with anxiety disorders via remote sessions in Japan: a study protocol

Por: Okawa · S. · Blackwell · S. E. · Violato · M. · Creswell · C. · Ishikawa · S.-i. · Obikane · E. · Takahashi · T. · Arai · H. · Nakamura · H. · Ishitsuka · K. · Shimizu · E. · Sasaki · T.
Introduction

Guided parent-delivered cognitive behavioural therapy (GPD-CBT) is an evidence-based, low-burden treatment programme for childhood anxiety disorders with demonstrated efficacy, cost-effectiveness and accessibility. However, it has been tested primarily in Western countries, and the efficacy and cost-effectiveness have not been evaluated in Japanese families. The current study aims to examine GPD-CBT’s efficacy and cost-effectiveness in Japanese samples and explore potential cultural adaptations of the programme.

Method and analysis

This study is designed as a Bayesian single-blind randomised controlled trial with two parallel groups: GPD-CBT (intervention group) and a waitlist control group. The primary outcome is remission of primary anxiety disorders evaluated through diagnostic interviews by independent evaluators. Secondary outcomes include child and parent-reported child anxiety symptoms, depressive symptoms and life interference. Additionally, measures of parental psychological characteristics, programme acceptability and quality of life are collected. We will conduct qualitative interviews with parents who participated in the programme and therapists who delivered the intervention to explore potential cultural adaptations. We aim to recruit 54–170 families, depending on the results of sequential Bayesian analyses. GPD-CBT consists of seven weekly 20 min sessions and a 1-month follow-up session. Assessments will be conducted at baseline, 13 weeks post randomisation (primary endpoint for between-group comparison), with an additional 25 weeks post randomisation. The waitlist control group will receive GPD-CBT after the 13-week assessment.

Ethics and dissemination

This study has been approved by the Ethics Review Committees of Chiba University and the University of Tokyo. We will disseminate results through academic conference presentations and peer-reviewed journal publications. If the GPD-CBT intervention proves efficacious, we will promote wider implementation in Japan through the development of training programmes for mental health professionals and key stakeholders.

Trial registration numbers

jRCT1032250421 (https://jrct.mhlw.go.jp/latest-detail/jRCT1032250421) and jRCT1030250422 (https://jrct.mhlw.go.jp/latest-detail/jRCT1030250422) registered on 9 October 2025.

Safety and efficacy of intrathecal pemetrexed and bevacizumab in non-small cell lung cancer (NSCLC) patients with leptomeningeal metastases (LM): protocol for a single-arm, prospective, phase Ia trial

Por: Kuang · Y. · Teng · J. · Wang · W. · Zhang · B. · Cheng · L. · Zhang · Y. · Liu · W. · Gao · Z. · Nie · W. · Xiong · L. · Shi · C. · Zhang · W. · Lou · Y. · Han · B. · Zhong · H.
Introduction

The prolonged survival of lung cancer patients is accompanied by an increasing incidence of leptomeningeal metastases (LM). Patients with LM have a poor prognosis, significantly impacting their quality of life and overall survival. Recent studies have shown that while intrathecal pemetrexed (IP) can improve symptoms and confer a survival benefit in non-small cell lung cancer (NSCLC) patients with LM, drug resistance remains a significant challenge. As for systemic therapy, intravenous bevacizumab combined with chemotherapy has demonstrated clinical benefits in NSCLC patients. However, clinical data on intrathecal bevacizumab remain scarce. Therefore, this study aims to preliminarily explore the efficacy and safety of intrathecal pemetrexed and bevacizumab in the treatment of NSCLC patients with LM.

Methods and analysis

This is a single-centre, single-arm, prospective, investigator-initiated phase Ia clinical trial sponsored by Shanghai Chest Hospital, involving patients with advanced NSCLC and LM. Participants will be enrolled and allocated into two predefined cohorts. Cohort A: six participants will receive IP monotherapy for safety exploration. Cohort B: participants will receive intrathecal pemetrexed and bevacizumab. Pemetrexed will be administered at a fixed dose, while the dosage exploration for bevacizumab will employ a combination of a 3+3 design and an accelerated titration design (ATD). The primary endpoint is the safety and the secondary endpoint is the overall survival (OS).

Ethics and dissemination

This study protocol (Version 1.1, dated 8 October 2024) was approved by the Ethics Commission of Shanghai Chest Hospital (IS24103) on 23 October 2024. Trial results will be published in a peer-reviewed journal.

Trial registration number

NCT06663306, ClinicalTrials.gov.

Prevalence of severe fatigue after SARS-CoV-2 infection in Norway: a prospective 2-year follow-up study

Por: Berg · K. K. · Sarjomaa · M. · Tveten · Y. · Thilesen · C. · Fell · A. K. M. · Nordbo · S. A. · Reiso · H. · Eikeland · R.
Objectives

This study aims to estimate the prevalence of long-lasting severe fatigue and identify possible risk factors in a 2-year follow-up of patients with predominantly mild-to-moderate SARS-CoV-2 infection.

Design

Prospective cohort study.

Setting

A community-based cohort from Telemark and Agder Counties, Norway.

Participants

A total of 159 PCR-confirmed SARS-CoV-2 positive individuals in the period between 28 February and 17 December 2020 were included at 12 months after SARS-CoV-2 infection, and 93 responded at 24 months follow-up.

Outcome measures

Fatigue was assessed using the Fatigue Severity Scale (FSS), and health-related quality of life using the RAND version of health-related quality of life Short Form 36 (SF-36), developed by the RAND Corporation. SARS-CoV-2 antibodies were measured at 12 and 24 months.

Results

Severe fatigue (FSS ≥5) was reported by 36% at 12 months and 31% at 24 months. A higher proportion of women than men reported severe fatigue at 12 months (p=0.08). The number of acute-phase symptoms was associated with severe fatigue. No association was found between severe fatigue and anti-SARS-CoV-2 antibody levels, demographic variables or reinfection status. The severe fatigue group scored significantly lower on all domains of SF-36.

Conclusion

In this cohort, severe fatigue was common, greatly impacted quality of life and persisted for up to 2 years following SARS-CoV-2 infection. Fatigue severity was associated with symptom burden in the acute phase but not with antibody levels or other demographic variables. These findings underscore the need for long-term follow-up and support for affected individuals.

Geographic barriers to gynaecological cancer care in Indonesia: a geospatial and infrastructure analysis

Por: Tjokroprawiro · B. A. · Sulistya · H. A. · Rahma · A. A. · Novitasari · K. · Ulhaq · R. A. · Yuliati · I. · Utami · T. W. · Anggraeni · T. D.
Objective

This study aimed to identify underserved regions and evaluate the population coverage based on travel time and distance to hospitals with gynaecologic oncologists in Indonesia.

Methods

The travel time and distance to hospitals with gynaecologic oncologists were evaluated using the Quantum Geographic Information System. Data from 139 gynaecologic oncologists and their affiliated hospitals were obtained from the Indonesian Society of Gynecologic Oncologists (November 2024) and cross-referenced with the Ministry of Health records. The female population density data were sourced from Facebook’s high-resolution settlement layer. Isochrones were generated to estimate travel times and distances using zonal statistics, which facilitated the calculation of population coverage.

Results

A total of 139 gynaecologic oncologists were identified nationwide, practising in 243 hospitals (7.6% of the 3202 hospitals in Indonesia), with a concentration in Java (60.4%). 11 of the 38 provinces lack sub-specialists. Population coverage varies sharply: the travel time to a hospital with gynaecologic oncologists is ≤2 hours for 79.1% of women in Java, compared with 4.9% in Papua; overall, 34.4% reside more than 100 km away from hospitals with gynaecologic oncologists. Hospitals with gynaecologic oncologists are predominantly urban class B general hospitals, and 83.1% participate in the National Health Insurance Schemes. Exploratory district-level correlations showed positive associations between the number of such hospitals and total female population (r=0.44, p

Conclusions

Gynaecological oncology services in Indonesia remain heavily concentrated in Java, leaving nearly one-fifth of women residing more than 100 km away. The travel time is greater than 2 hours for many. Targeted expansion of the gynaecologic oncologists workforce, diagnostic and treatment infrastructure, and sustainable financing mechanisms are required to close these gaps.

Liposomal bupivacaine versus standard ropivacaine for pain control in adults receiving continuous supraclavicular brachial plexus blocks for open elbow arthrolysis: study protocol for a randomised controlled non-inferiority clinical trial

Por: Luo · T. · Zheng · S. · Zhao · Y. · Yang · X. · Li · X. · Ji · Y. · Wang · Y. · Tang · H. · Xiao · R. · Zhang · W. · Li · T. · Wang · G. · Yuan · Y.
Introduction

Open elbow arthrolysis effectively treats post-traumatic elbow stiffness, but severe postoperative pain during early rehabilitation impedes recovery. Continuous brachial plexus blocks, though effective, face limitations such as catheter displacement and infection risks. Liposomal bupivacaine, an ultra-long-acting local anaesthetic, offers prolonged analgesia and may circumvent these challenges. This study aims to compare the analgesic efficacy of a single-dose liposomal bupivacaine supraclavicular block versus continuous ropivacaine infusion in patients undergoing open elbow arthrolysis.

Methods and analysis

This single-centre, randomised, double-blind, non-inferiority trial will enrol 72 adults (ASA I–III,the American Society of Anesthesiologists physical status classification for preoperative risk) scheduled for open elbow release surgery. Participants will be randomised (1:1) to receive either a single supraclavicular block with 10 mL liposomal bupivacaine plus 10 mL 0.5% ropivacaine followed by saline infusion (liposomal bupivacaine group) or continuous catheter infusion with 20 mL 0.5% ropivacaine followed by 0.2% ropivacaine infusion (control group). The primary outcome is the weighted area under the curve (AUC) of Numerical Rating Scale (NRS) pain scores during functional exercises within 72 hours postoperatively. Secondary outcomes include resting NRS scores, sleep quality (Pittsburgh Sleep Quality Index), rehabilitation metrics (range of motion, grip strength), recovery quality (Quality of Recovery -15) and long-term functional outcomes (Quick Disabilities of the Arm, Shoulder and Hand scores, Quick-DASH scores) at 2 weeks, 6 weeks and 12 weeks. Non-inferiority will be established if the upper 95% confidence limit of the AUC difference is ≤1.3. Statistical analyses will employ intention-to-treat principles with SPSS V.24.0.

Ethics and dissemination

Ethical approval was granted by Beijing Jishuitan Hospital Ethics Committee (K2025-213-00). The trial is registered with the Chinese Clinical Trial Registry (ChiCTR2500103911). Results will be disseminated via peer-reviewed journals, contributing evidence on liposomal bupivacaine’s role in perioperative analgesia and rehabilitation for elbow surgery.

Trial registration number

Chinese Clinical Trial Registry (ChiCTR ID provided on acceptance).

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