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COVID-19 antibody testing study: a nested substudy within Albertas Tomorrow Project (ATP) in Alberta, Canada

Por: Nejatinamini · S. · Charlton · C. · Harman · S. · Kanji · J. N. · Kellner · J. D. · Lines · K. · Murdoch · K. · Powell · W. · Roberts · J. · Rosner · W. · Shen-Tu · G. · Tipples · G. · Xu · J.-Y. · Vena · J. E.
Purpose

The Alberta’s Tomorrow Project (ATP) prospective cohort study was established in 2000 to investigate the causes of cancer and chronic disease. The cohort consists of almost 55 000 participants aged 35–69 years at the time of recruitment. From 2020 to 2022, ATP conducted a longitudinal substudy, the COVID-19 Antibody Testing (CAT) study, nested in this existing cohort, to understand the spread and impact of the SARS-CoV-2. In this cohort profile, we describe the CAT study design, recruitment and initial findings.

Participants

In this prospective cohort substudy, ~4000 participants completed online surveys and provided blood samples at a study centre every 4 months for 1 year, across four cities in Alberta, Canada. The study was launched on a rolling basis beginning in September 2020 and data collection was completed in May 2022. The surveys collected information on health and lifestyle factors, COVID-19 (testing, symptoms, vaccination, public health recommendations) and impacts of the pandemic (including economic, health services, mental health). Blood samples were tested for antinucleocapsid and antispike protein SARS-CoV-2 antibodies.

Findings to date

A total of 4102 participants consented and attended a study centre at baseline, and almost 90% of these completed the study. Overall, participants were aged 61±10 years, 60% female, 12% came from rural areas, 45% had at least a bachelor’s degree, 24% reported a household income 4 weeks). By the end of the study, 96% of participants had received at least one COVID-19 vaccine dose. Through investigating other outcomes, it was observed that participants under 50 years of age were more likely to be assessed to have mild or moderate-to-severe anxiety and depressive symptoms compared with older participants. In addition, approximately 15% of participants reported a moderate to major impact on their ability to meet financial obligations.

Future plans

Serology results, together with health, lifestyle and sociodemographic data, and the continued follow-up of these participants as part of the broader ATP cohort study (planned through 2065), will provide opportunities to investigate the long-term sequelae of COVID-19 infection as well as the broader impacts of the pandemic on physical, mental and emotional health. Data are available to researchers on request through the ATP access process.

Effect of central combined with peripheral intermittent theta burst stimulation on motor function in patients with hereditary spastic paraplegia: study protocol for a randomised controlled trial

Por: He · J.-P. · Yan · X.-Y. · Wang · Z.-Y. · Liu · X.-H. · Jiang · J.-Y. · Xiao · B. · Zhu · J.-P. · Zhang · N.-N. · Han · Q. · Zhan · L.-Q. · Qiu · X. · Lin · X. · Ni · J. · Lin · X.-H.
Introduction

Hereditary spastic paraplegia (HSP) is a rare neurodegenerative disorder characterised by spasticity and weakness in both lower limbs due to axonal degeneration of the corticospinal tract. Motor dysfunction is a key clinical feature of HSP, severely impacting patients’ ability to work and perform daily activities. Intermittent theta burst stimulation (iTBS), a specific form of transcranial magnetic stimulation, can induce excitatory effects by modulating stimulation duration and interval. Recently, the central-peripheral-central closed-loop rehabilitation model has gained significant attention, and its core concept is to integrate central and peripheral interventions. The objective of this study is to evaluate the effect of central combined with peripheral iTBS on motor function in adults with HSP.

Methods and analysis

In this randomised controlled trial, 40 patients admitted to the First Affiliated Hospital of Fujian Medical University will be randomly assigned (1:1 ratio) to either active iTBS or sham iTBS groups. iTBS will be administered to the bilateral primary motor cortex and common peroneal nerve, delivering a total of 4800 pulses, five times a week for 2 weeks. Throughout the iTBS treatment period, participants will also engage in conventional rehabilitation training for 30 min, five times a week for 2 weeks. The primary outcome measure will be assessed using the 10 Metre Walk Test at baseline, postintervention and 4 weeks after the intervention ends. Secondary outcomes will include the Spastic Paraplegia Rating Scale, the Modified Ashworth Scale, the Medical Research Council scale, the Berg Balance Scale, Pro-Kin balance centre of pressure parameters, the Timed Up and Go Test, RealGait gait parameters and neuro-electrophysiological indicators. Additionally, any adverse events will be recorded.

Ethics and dissemination

This study was approved by the Ethics Committee of the First Affiliated Hospital of Fujian Medical University (Approval No.: MRCTA, ECFAH of FMU (2024)862). All participants will be required to provide written informed consent. The results of the study will be submitted for publication in peer-reviewed journals.

Trial registration number

ChiCTR2500097169.

Effect of acupuncture stimulation on trigger points in patients with lumbar back myofasciitis: a protocol for a single-centre, randomised, controlled clinical trial

Por: Song · X. · Chen · Z. · Yin · J. · Chen · Z. · Rao · Y. · Zhao · J. · Zhu · H. · Zhang · J. · Pu · X. · Li · R. · Wang · J.-y.
Introduction

Lumbar back myofasciitis (LBM) is a common condition caused by cold exposure, lumbar injuries or poor posture, leading to aseptic inflammation, fibrosis and chronic pain. While acupuncture stimulation of trigger points is widely used, clinical evidence supporting its efficacy remains limited. This study aims to evaluate the effectiveness and safety of acupuncture stimulation of trigger points in the treatment of LBM and to explore the underlying analgesic mechanisms.

Methods and analysis

This single-centre randomised controlled trial will be conducted at Acupuncture and Moxibustion Hospital of China Academy of Chinese Medical Sciences. A total of 60 participants will be randomly assigned to either the experimental group or the control group in a 1:1 ratio. The primary outcome measure will be the Visual Analogue Scale for pain, while secondary outcomes will include pressure pain threshold, ultrasound, infrared thermography and Roland-Morris Disability Questionnaire.

Ethics and dissemination

Ethics approval was obtained from the Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences (Approval No. 2024XLW007-2). The findings of this study will be published in peer-reviewed journals. Prior to participation, all eligible participants will be given informed consent.

Trial registration number

ITMCTR2025000258.

Effects of remote rehabilitation weekend training for stroke patients in China: a randomised controlled trial protocol

Por: Zhang · Y. · Sun · P.-P. · Zhu · S.-Y. · Wu · J.-Y. · Chu · Y.-T. · Wu · Y.-Q. · Jiang · Y.-X. · Liu · S.-Y. · Bai · Y. · Xiang · Y.-W.
Introduction

Stroke is one of the leading causes of disability and mortality worldwide, particularly in China, where it imposes significant economic and psychological burdens on patients and their families. Traditional in-hospital rehabilitation is often limited by resource constraints, leading to interruptions in weekend therapy, which can delay recovery. Remote rehabilitation platforms offer a potential solution by providing continuous, therapist-guided rehabilitation training during weekends. This study aims to evaluate the effectiveness of a remote rehabilitation training platform in improving motor function, self-efficacy and social participation in stroke patients while also assessing its impact on caregiver burden. The findings will provide evidence for the integration of remote rehabilitation into stroke care protocols, offering a scalable solution to enhance recovery and reduce societal costs.

Methods and analysis

A total of 168 stroke patients will be recruited from three hospitals in Shanghai and randomly assigned to either an intervention group or a control group. A remote rehabilitation platform will be used to perform guided exercises on weekends for the intervention group, whereas the control group will receive standard in-hospital rehabilitation. Primary outcomes will be assessed using the 10 metre walk test, and secondary outcomes will include the Barthel Index, Fugl–Meyer motor function assessment and Zarit Caregiver Burden Scale.

Ethics and dissemination

This study was approved by the Ethics Committee of the Institutional Review Board of Shanghai University of Traditional Chinese Medicine (Ethics Approval Number: 2024-2-14-01). All participants will provide written informed consent prior to enrolment. Trial results will be disseminated through peer-reviewed publications, presentations at international stroke and rehabilitation conferences, and engagement with patient advocacy groups. Findings will also be shared with healthcare policymakers to promote the integration of remote rehabilitation into clinical practice. Individual participant data will remain confidential and be stored securely in accordance with data protection regulations.

Trial registration number

This trial was registered with the Chinese Clinical Trial Registry (Registration number: ChiCTR2500101741). The date of registration was 29 April 2025.

Antithrombotic strategies in adult COVID-19 patients: a systematic review and Bayesian network meta-analysis

Por: Chen · H.-B. · Chen · H. · Xu · J.-Y. · Yu · R.-X. · Shi · N. · Chi · Y. · Ge · Y.-Y. · Cui · L.-B. · Zhang · S. · Xie · J. · Qiu · H.
Objectives

To systematically compare the effects of various antithrombotic strategies on prespecified outcomes including 28-day all-cause mortality (primary outcome), major thrombotic events and major bleeding events (secondary outcomes) in adult COVID-19 patients.

Design

Systematic review and Bayesian network meta-analysis (NMA).

Data sources

PubMed, Web of Science, Embase, Cochrane Library and ClinicalTrials.gov up to February 2024.

Eligibility criteria

We included randomised controlled trials (RCTs; published in English) comparing different antithrombotic strategies (eg, anticoagulants, antiplatelet (AP) agents, fibrinolytics or combinations) in adults (aged≥18 years) with laboratory-confirmed SARS-CoV-2 infection. Eligible trials had at least one active antithrombotic arm versus another strategy or standard care.

Data extraction and synthesis

Two reviewers independently extracted data using a standardised form; disagreements were resolved by consensus or third-party adjudication. Bayesian NMA was performed using Markov chain Monte Carlo methods with random/fixed effects models selected by the deviance information criterion. The risk of bias (RoB) was assessed using the Cochrane Collaboration’s tool. The confidence in NMA framework was used to assess the quality of evidence.

Results

35 RCTs that randomly assigned 39 949 participants were included in the main analysis. Primary outcome: evidence of low to moderate certainty suggested that, compared with standard of care (SoC), both prophylactic-dose anticoagulation (PA) (risk ratio (RR) 0.71, 95% credible interval (CrI) 0.44 to 0.99) and therapeutic-dose anticoagulation (TA; RR 0.65, 95% CrI 0.38 to 0.94) reduced the 28-day all-cause mortality. Secondary outcomes: TA (RR 0.19, 95% CrI 0.09 to 0.31), TA+AP (RR 0.27, 95% CrI 0.05 to 0.95), PA (RR 0.33, 95% CrI 0.18 to 0.53) and AP+PA (RR 0.52, 95% CrI 0.25 to 0.94) were effective in reducing major thrombotic events. AP was associated with an increased risk of major bleeding events (RR 2.27, 95% CrI 1.01 to 5.07). Subgroup analyses by hospitalisation status showed that PA significantly reduced 28-day mortality versus SoC (RR 0.52, 95% CrI 0.26 to 0.90) for non-hospitalised patients, whereas no strategies showed significant benefit in hospitalised patients. Subgroup analysis based on severity of hospitalised patients indicated that TA was more favourable than PA in decreasing the 28-day mortality in non-critically ill patients (fixed-effect model: RR 0.75, 95% CI 0.61 to 0.91; random-effect model: RR 0.71, 95% CI 0.48 to 1.05), but for critically ill patients, all antithrombotic strategies showed no significant difference.

Conclusions

Our NMA indicates that both PA and TA reduced the 28-day all-cause mortality of adult COVID-19 patients. However, subgroup analyses revealed substantial heterogeneity, and the benefit may differ across hospitalisation status and disease severity.

PROSPERO registration number

CRD42022355213.

Patient perception of physician attire: a systematic review update

Por: Kim · J. · Ba · Y. · Kim · J.-Y. · Youn · B.-Y.
Objective

This systematic review aims to update and analyse patient perceptions of physician attire, focusing on its impact on the physician–patient relationship across different medical settings and specialties.

Design

A systematic review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-analyses criteria.

Data sources

PubMed, Embase, Cochrane Library and Google Scholar were searched for relevant studies from 1 January 2015 to 1 June 2025.

Eligibility criteria

This review examined studies focused on physician attire and its impact on patient perceptions.

Data extraction and synthesis

Studies were assessed based on authors, study setting, study design, objective, study population, physician specialty, measures, findings, main conclusion and risk of bias. Then, thematic analysis was employed to synthesise the findings of the articles.

Results

28 studies met the inclusion criteria. Patient preferences for physician attire varied significantly by clinical context, medical specialty and physician gender. In outpatient and primary care settings, mixed evidence was reported, with some studies suggesting that a combination of casual attire and white coats may foster approachability and communication, while others showed no clear preference. In contrast, in high-acuity settings such as emergency rooms and operating theatres, scrubs were consistently favoured, indicating moderate to strong evidence for the association with professionalism and preparedness. During the COVID-19 pandemic, patients expressed stronger preferences for scrubs and PPE, emphasising infection prevention and hygiene. Gender-specific findings indicated that male physicians were perceived as more professional when wearing formal attire with white coats, while female physicians in similar attire were often misidentified as nurses or assistants. Specialty-based differences were also observed, with preferences for white coats in dermatology, neurosurgery and ophthalmology, while scrubs were preferred in anaesthesiology and gastroenterology.

Conclusion

This study demonstrates that physician attire consistently and significantly impacts patients’ perceptions of professionalism, trust and communication. The collective findings provide robust evidence that these perceptions are highly context-dependent, necessitating adaptable dress codes tailored to clinical environments and patient expectations to enhance trust and patient satisfaction.

Trial registration

https://osf.io/kjr4p

Oral-gut microbiome axis in a Korean cohort with inflammatory bowel disease and ankylosing spondylitis (INTEGRATE): a prospective and observational study protocol

Por: Kim · H. S. · Kim · B.-H. · Nam · B. · Oh · S. J. · Park · S.-K. · Lee · S. W. · Lee · J.-Y. · Jo · S. · Lee · Y.-A. · Lee · J.-Y. · Park · D. I. · Kim · T.-H. · Lee · C. K.
Introduction

The global burden of chronic immune-mediated inflammatory diseases (IMIDs) is increasing, and rising prevalence rates significantly affect socioeconomic factors and quality of life. Inflammatory bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), along with ankylosing spondylitis (AS), are prominent chronic IMIDs that share overlapping pathophysiological mechanisms. Recent research has highlighted the importance of the gut microbiota in the pathogenesis of these diseases, suggesting that shared microbial dysbiosis may contribute to their development. Comprehensive research focusing on the gut and oral microbial characteristics and environmental factors is essential to elucidate the fundamental pathophysiology and develop personalised management strategies for IBD and AS. In-depth analyses and insights based on multiomics approaches are required to achieve these objectives.

Methods and analysis

This protocol describes a nationwide prospective observational study of CD, UC and AS in a Korean population. Over 5 years, we aim to recruit at least 900 patients with IBD and 200 first-degree relatives (FDRs), 500 patients with AS and 200 of their FDRs, and 2244 healthy controls. We will systematically collect clinical data and biological samples, including saliva, stool, blood and tissue biopsies, for integrative multiomics analyses focusing primarily on the microbiome. Highly advanced full-length 16S ribosomal RNA gene sequencing and shotgun metagenomics will be used to characterise the microbial composition of saliva and stool samples. Quantitative microbiome profiling will be used to address the pathological, physiological and ecological differences between microbial groups that may be masked by their relative abundance. Metabolomic analyses will be conducted on saliva, stool and plasma samples to assess functional metabolic profiles. Culturomics will be used to isolate, identify and characterise the diversity of microbial species, including rare or previously unrecognised species, to provide a comprehensive understanding of the microbiota associated with these diseases.

Ethics and dissemination

Ethical approval was obtained from the Ethics Committee of Kyung Hee University Hospital, Hanyang University Hospital, Kangbuk Samsung Hospital, Yeungnam University Hospital, Kyungpook National University Hospital, Chonnam National University Hospital, Wonkwang University Hospital, Catholic University Daejeon St. Mary’s Hospital, Soon Chun Hyang University Hospital Cheonan, Chung-Ang University Hospital, Inje University Haeundae Paik Hospital, Dankook University Hospital, Hanyang University Guri Hospital, Kyung Hee University Hospital at Gangdong, Chung-Ang University Gwangmyeong Hospital and Keimyung University Dongsan Hospital. Our research team will provide detailed information about the study, including an information sheet explaining its aims and procedures, prior to enrolment. Prospective participants will be informed that they have the right to withdraw from the study at any time, without penalty. Participants will be assured of the anonymity and confidentiality of any data they provide throughout the study, using participant numbers and the storage of sensitive data in locked cabinets. Participants will be enrolled in the study only after providing written informed consent to the research staff. The results of this study will be disseminated to healthcare and academic professionals through publications in peer-reviewed journals and presentations at international conferences.

Trial registration number

This prospective observational study is registered at ClinicalTrials.gov ((ID: NCT06124833, data first posted: 9 November 2023); (ID: NCT06076083, data first posted: 21 November 2023) and (ID: NCT06183697, data first posted: 27 December 2023)).

Characterisation of a clinical trial-like population of high cardiovascular risk patients prior to myocardial infarction or stroke in the real world: design and protocol for a multidatabase retrospective cohort study

Por: Ochs · A. · Chan · Q. · Dhalwani · N. N. · Duxbury · M. · Shannon · E. · OKelly · J. · Paiva da Silva Lima · G. · Avcil · S. · Chan · A. Y. · Chui · C. S. · Lai · E. C.-C. · Cars · T. · Shin · J.-Y. · Heintjes · E. M. · Wong · I. C.
Introduction

Cardiovascular (CV) disease is the leading cause of morbidity and mortality globally. Low-density lipoprotein cholesterol (LDL-C) is an important modifiable risk factor of major adverse cardiovascular events. Patients without prior myocardial infarction (MI) or stroke but with established risk factors and elevated LDL-C may benefit from intensive lipid-lowering therapy (LLT); however, the size and potential healthcare burden of this population globally are not known. The benefits of evolocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, in these patients, are currently being studied in the phase 3 Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke (VESALIUS-CV) trial. To characterise the high-risk pre–CV-event (VESALIUS-CV–like) individuals in the real world, an observational study is being conducted across multiple countries.

Methods and analysis

This retrospective cohort study will use a common protocol and an analytical common data model approach to characterise VESALIUS-CV–like individuals in the real world across different geographical regions and healthcare settings. The study period will be from 2010 to 2022, subject to data availability in study sites. Patients aged 50 years and older at high risk of CV disease but without prior MI or stroke will be included in this study. VESALIUS-CV–like individuals are defined through a combination of the following: (1) one diagnosis of coronary artery disease, cerebrovascular disease, peripheral artery disease or diabetes with microvascular complications or chronic insulin use; (2) an elevated LDL-C measurement and (3) other high-risk factors. The objectives of this study are to estimate the prevalence of VESALIUS-CV–like individuals, describe their characteristics and care pathways and estimate their incidence rates of CV events and healthcare costs. The prevalence of VESALIUS-CV–like individuals will be expressed as annual prevalence; patient characteristics at index date will be presented using summary statistics; care pathways will be summarised as LLT prescription across time; and the incidence of defined CV events will be expressed as events per person-years as well as at certain time periods. Healthcare costs will be presented as CV-related costs in different time periods.

Ethics and dissemination

Approvals of the study protocol were obtained from relevant local ethics and regulatory frameworks for each participating database. The results of the study will be submitted to peer-reviewed scientific publications and presented at scientific conferences.

Acupuncture for preventing chemotherapy-induced peripheral neuropathy: study protocol for a randomised controlled trial

Por: Li · B.-Y. · Liu · C.-Z. · Zhou · H. · Wei · X.-Y. · Jia · J.-Y. · Wang · J. · Guo · X.-Y. · Liang · W. · Tu · J.-F. · Wang · L.-Q. · Shi · G. · Yang · J.-W. · Yang · N.-N.
Introduction

Chemotherapy-induced peripheral neuropathy (CIPN) is the most prevalent non-haematological, dose-limiting adverse event associated with platinum derivatives and taxanes. Currently, no effective prophylactic interventions for CIPN have been established. However, several studies have shown that acupuncture may alleviate symptoms of peripheral neuropathy, proposing it as a potentially effective strategy for CIPN prevention. This pilot trial will help determine the feasibility and efficacy of acupuncture for preventing CIPN. The results will provide valuable insights for designing a larger clinical trial and conducting power calculations.

Methods and analysis

This is a randomised sham-controlled trial. A cohort of 60 patients scheduled to receive chemotherapy will be enrolled and randomly assigned to either the electroacupuncture group or the sham acupuncture group. Eligible patients will receive nine treatment sessions administered over the course of three chemotherapy cycles. The primary outcome is the change in CIPN-related quality of life (QOL) measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) CIPN20 from baseline to the end of cycle three. Secondary outcomes include: neurotoxicity symptoms assessed by the Numeric Rating Scale, incidence of CIPN, chemotherapy status, insomnia symptoms measured by the Insomnia Severity Index, depression symptoms evaluated using the Beck Depression Inventory-II, anxiety symptoms assessed with the Generalised Anxiety Disorder-7 and fatigue symptoms measured by the Brief Fatigue Inventory. Adverse events will be meticulously recorded.

Ethics and dissemination

The study protocol (V.1.0, 29 July 2024) has been approved by the First Affiliated Hospital of Zhengzhou University (2024-KY-0853–001). All patients will provide oral informed consent and written informed consent before participating in this study. Trial results will be disseminated in peer-reviewed publications.

Trial registration number

ITMCTR2024000390 (International Traditional Medicine Clinical Trial Registry, http://itmctr.ccebtcm.org.cn/zh-CN/Home/ProjectView?pid=16387992-8971-4218-9cd0-b623af91f9f3), registered on 3 September 2024.

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