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Developing consolidated guidelines for reporting and evaluation of studies using transcranial electrical stimulation (CoRE-tES): protocol for an international Delphi study and expert consensus process

Por: Suhood · A. Y. · Summers · S. · Pascual-Leone · A. · Nitsche · M. A. · Ziemann · U. · Bikson · M. · Lefaucheur · J.-P. · Brunoni · A. R. · Bestmann · S. · Chipchase · L. S. · Razza · L. B. · Cavaleri · R.
Introduction

In recent decades, transcranial electrical stimulation (tES) has become a widely used non-invasive method for modulating brain function in clinical and non-clinical populations. However, existing tES trials exhibit substantial methodological heterogeneity, often limiting the reproducibility and interpretability of findings. There currently exists a paucity of consensus-driven, standardised recommendations outlining the key factors that should be reported and/or controlled in tES studies. Accordingly, this project aims to develop Consolidated Guidelines for Reporting and Evaluation of studies using tES (CoRE-tES), a tool designed to assess the methodological quality and reporting of laboratory-based and home-based tES studies. These guidelines will support improved quality, consistency, replication and transparency in research involving tES modalities, including transcranial direct current stimulation, transcranial alternating current stimulation and transcranial random noise stimulation.

Methods and analysis

CoRE-tES will be developed and disseminated over five stages. Stage 1 will comprise a review of recent tES literature to assess methodological and reporting quality. Stage 2 will employ a Delphi process to seek agreement among international tES experts on a list of items for inclusion in CoRE-tES. In stage 3, a consensus meeting will be held to synthesise and prioritise the agreed items to form CoRE-tES. Stage 4 will involve production of the final CoRE-tES checklist and an accompanying evaluation and elaboration document. In stage 5, CoRE-tES will be disseminated via journal publication, conferences, professional meetings and social media campaigns.

Ethics and dissemination

Ethics approval has been obtained from the Western Sydney University Human Research Ethics Committee (approval number H16803). Findings will be disseminated through scientific conferences and peer-reviewed journal publications, and CoRE-tES will be indexed on the Enhancing the QUAlity and Transparency Of health Research Network website.

Characterising ocular injuries in competitive combat sports in Texas: a retrospective case-control study

Por: Akanno · U. E. · Malik · M. · Alik · M. · Ashrafi · R. · Nguyen · A. X.-L. · Wu · A. Y.
Objective

This study aims to determine the incidence and impact of ocular injuries among the different combat sports disciplines of boxing, mixed martial arts (MMA), kickboxing and Muay Thai in Texas, USA.

Design

A case–control study was conducted to analyse retrospective postmatch physical reports from combat sports matches that took place in the state of Texas from January 2019 to January 2022. Ocular injuries and other match characteristics such as sport type and match outcome were identified by postmatch physical reports. Postmatch physical reports were collected from the Texas Department of Licensing and Regulation database. Statistical analysis was used to stratify injuries and compare the impact of injuries on match outcome.

Setting

Combat sports fighters in Texas, USA.

Participants

3070 participants were included in the study. Participants were fighters who participated in combat sports matches in Texas, USA, between January 2019 and January 2022.

Primary and secondary outcome measures

The original plan was to measure the incidence of ocular injuries across different combat sports including boxing, MMA, kickboxing and Muay Thai. However, due to a limited sample size of kickboxing and Muay Thai matches, the ocular injury incidence was only measured for boxing and MMA. The association between ocular injury and match outcome was assessed using 2 statistical analysis.

Results

The respective incidence rates of ocular injuries in boxing and MMA were 9.7 and 12.2 injuries per 100 matches. The association between ocular injury and match outcome (win, lose or draw) was statistically significant in boxing but not statistically significant in MMA matches.

Conclusions

Our findings revealed that ocular injuries are significantly associated to losing a boxing match (p=0.011), but not associated to match outcome in MMA (p=0.232). Additionally, MMA matches report a larger variety of ocular injuries compared with boxing matches.

Cardioprotective and mentally protective effects of the Mediterranean-dietary approaches to stop hypertension intervention for neurodegenerative delay diet combined with forest bathing among adults with elevated blood cholesterol: a parallel group randomi

Por: Law · P. S. Q. · Yau · K.-Y. · Wong · D. C. · Yuen · K.-S. · Yu · C.-P. · Loke · A. Y.
Introduction

The prevalence of cardiovascular diseases (CVDs) is rapidly increasing across Asia, with the burden particularly high among individuals aged ≥50 years. Elevated low-density lipoprotein cholesterol (LDL-C) level is a well-established causal risk factor for CVDs. Mediterranean-Dietary Approaches to Stop Hypertension Intervention for Neurodegenerative Delay (MIND) diet is a cardioprotective diet, which is rich in plant-based foods. Combining it with stress-reducing practices, including forest bathing (FB), which involves immersive exposure to forest environments, has been shown to reduce LDL-C levels and other cardiovascular risk factors by modulating pro-inflammatory responses. However, existing evidence is limited due to small sample sizes and poor study design. Therefore, this study aims to investigate whether the MIND diet combined with FB can reduce CVD risks among Chinese adults in Hong Kong. It also compares the effects of the MIND diet combined with FB on cardiovascular and mental health.

Methods and analysis

A single-blind, randomised controlled trial involving three groups will be used to assess the impact of the MIND diet combined with FB on LDL-C levels in adults aged 50–75 years with elevated LDL-C levels. Participants (n=273) from local community centres will be randomly assigned to the MIND-plus-FB (who will receive nutrition education, follow the MIND diet for 12 weeks and participate in regular FB sessions), MIND-alone (who will receive nutrition education and follow the MIND diet for 12 weeks) or routine care (who will continue their usual activities and receive a general health talk along with pamphlets on cardiovascular risks) group. The change in LDL-C levels will be measured at weeks 4 and 12 (primary outcome). Additionally, changes in high-density lipoprotein cholesterol level, triglyceride level, glucose level, systolic blood pressure, waist circumference, body mass index, anxiety levels and emotional state will also be assessed at weeks 4 and 12. Statistical analyses will include intent-to-treat, 2 test, analysis of variance and generalised estimating equations.

Ethics and dissemination

This study has been approved by the Research Ethics Committee of Tung Wah College, Hong Kong (reference number: REC2023164). Research findings will be disseminated through publication in peer-reviewed journals and presentations at academic and primary healthcare conferences.

Trial registration number

ClinicalTrials.gov ID: NCT06222632, registered on 25 January 2024. The ClinicalTrials.gov data are available at: https://clinicaltrials.gov/study/NCT06222632?term=NCT06222632&rank=1&a=2&tab=history

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.

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