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Mediating effect of coping styles between self-efficacy and diabetes distress among Chinese patients with diabetic retinopathy: a cross-sectional study

Por: Zhang · X. · Zhang · M. · Xia · W. · Chen · Y. · Dai · J. · Huang · J. · Tan · J.-P. · Chen · Y.
Background

Diabetes distress (DD) constitutes a negative emotional experience for patients with diabetic retinopathy (DR), having a detrimental impact on their physical and mental health.

Objective

The aim of this study was to understand the current status and influencing factors of DD in patients with DR and to explore the relationship between self-efficacy, coping styles and DD.

Design

A cross-sectional study.

Setting

The study was conducted at the Eye Hospital of Wenzhou Medical University, Zhejiang Province, China.

Participants

Patients diagnosed with DR.

Main outcome measures

The Diabetes Distress Scale was used to assess DD.

Results

DD was present in more than half (53.07%) of patients with DR. There were significant differences in DD among patients with DR who reported different employment statuses, modes of residence and body mass index. Coping styles partially mediated the relationship between self-efficacy and DD, with the mediating effect accounting for 71% of the total effect.

Conclusion

Considering the high prevalence of DD among patients with DR, healthcare professionals should pay more attention to the psychological needs of patients with DR. Effective interventions could be used to promote self-efficacy and coping styles of patients with DR, leading to lower levels of DD.

Robot-assisted versus standard laparoscopic approach of total hysterectomy for deep infiltrating endometriosis and adenomyosis (ENDORAS TRIAL): study protocol for a randomised controlled trial

Por: Renso · M. · Bendifallah · S. · Estrade · J.-P. · Merlot · B. · Roman · H. · Vidal · F. · Collinet · P.
Introduction

Endometriosis affects 5–10% of women during reproductive years, with a 20–30% incidence among those with infertility. Deep infiltrating endometriosis (DIE) affects 10–15% of women of childbearing age and 50% of infertile women. When hormonal therapy and conservative surgery prove ineffective, total hysterectomy with or without bilateral salpingo-oophorectomy may be the ultimate therapeutic option. Laparoscopic surgery is the gold standard for treating endometriosis, offering effective disease eradication, safety, reduced pain, shorter hospital stay and faster recovery compared with laparotomy. However, patients undergoing total laparoscopic hysterectomy with DIE have higher risks of complications and organ damage, particularly urinary tract damage. Robot-assisted laparoscopic hysterectomy has emerged as a promising alternative, with a significantly lower conversion rate than total laparoscopic hysterectomy in patients with endometriosis. This study evaluates the safety and efficacy of robot-assisted total laparoscopic hysterectomy (RATLH) versus total laparoscopic hysterectomy (TLH) in the management of DIE. We hypothesise that robot-assisted laparoscopic hysterectomy will result in fewer complications and better outcomes compared with total laparoscopic hysterectomy in DIE patients.

Methods and analysis

The ENDORAS trial is a prospective, multicentre, open-label, randomised controlled trial conducted in French reference hospitals specialising in endometriosis surgery. A total of 224 adult women patients will be enrolled in this study if they have DIE with adenomyosis, and without digestive tract involvement as confirmed by MRI. Participants will be randomised to undergo either RATLH or TLH. The primary outcome will be the intraoperative and postoperative complication rates, classified according to the Clavien-Dindo classification (grade 2 or above) at the 3-month postoperative follow-up. Among the secondary outcomes, we will evaluate the quality of life using various questionnaires, including the Endometriosis Health Profile-30, the Short Form-306 and the Female Sexual Function Index.

Ethics and dissemination

The ENDORAS trial will be conducted in accordance with the International Council on Harmonization Good Clinical Practice guidelines. All trial documents and procedures have been reviewed and approved by the Ethics Committee Ile de France II (approval ID number: 24.01408.000300). Informed consent will be obtained during the preoperative check-up by the operating gynaecologist. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, broadcast media, print media and the internet.

Trial registration number

NCT06445179. Registered on 14 November 2024.

Improving the interface for information transfer in acute stroke care: a mixed-methods process evaluation of the emergency use case within the CAEHR project

Por: Wendel · J. · Hofmann · A.-L. · Scriba · S. · Bavendiek · U. · Ertl · M. · Hametner · C. · Klinger · A. · Krefting · D. · Mehdi · M. · Volkmann · J. · Zech · C. · Haeusler · K. G. · Heuschmann · P. · Reese · J.-P.
Objective

Prehospital notification by emergency medical services (EMS) can activate hospital resources before the patient arrives, which has been shown to improve in-hospital care for stroke patients. Optimising prehospital and handover processes in stroke care requires considering end-user perspectives to enhance acceptance and effectiveness of the developed solutions. The aim of this study was to identify current barriers in the preclinical-clinical phase of stroke care.

Design and setting

Within the investigator-initiated CAEHR project (CArdiovascular diseases—Enhancing Healthcare through cross-sectoral Routine data integration), an interface for transferring data from the electronic prenotification system to the hospital information system is implemented. A mixed-methods approach with semi-structured interviews as well as a cross-sectional online survey was used to gather feedback from healthcare professionals at a single stroke centre in Germany as well as from the participating EMS personnel. Data collection for the interviews was conducted between January and August 2023 and for the online survey between May and September 2023.

Participants

Interviews were conducted with 10 healthcare professionals, including seven from the neurological clinic and three from EMS. Additionally, 39 EMS employees took part in a cross-sectional online survey.

Results

Challenges identified were educational and training aspects affecting preclinical processes and patient handover procedures, along with the opportunity for establishing more uniform protocols. Participants emphasised the importance of detailed patient information. Electronic prenotification was seen as an important step regarding structured information transmission, reducing the risk of information loss in stroke care.

Conclusion

The study highlights the importance of addressing organisational processes in addition to technical interfaces for implementing effective stroke care processes.

Trial registration number

German Clinical Trials Register, DRKS00029103.

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.

Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis (SONIC-GCA): protocol for a prospective, multicentre diagnostic test accuracy study

Por: Makhzoum · J.-P. · Mendel · A. · Touati · A. · Marcotte · G. · Barra · L. · Pagnoux · C.
Introduction

Giant cell arteritis (GCA) is a vision-threatening systemic vasculitis for which no universally accessible diagnostic tool exists. Optic nerve sheath diameter (ONSD), measurable via ultrasound, has emerged as a promising, non-invasive biomarker of cranial GCA. The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis (SONIC-GCA) aims to validate ONSD ultrasound as a diagnostic and monitoring tool in GCA.

Methods and analysis

SONIC-GCA is a prospective, multicentre study enrolling patients referred for the evaluation of suspected GCA. A total of 285 participants will undergo optic nerve sheath ultrasound and digital retinal funduscopy, followed by a standardised GCA assessment. All participants will be followed for a minimum of 6 months, at which time an external adjudication committee will confirm the diagnosis of GCA. Those diagnosed with GCA will be followed for 2 years, with repeated optic nerve sheath ultrasound and digital retinal funduscopy at months 3, 6, 12, 18, 24 and at relapse, if applicable.

The primary outcome is the diagnostic accuracy of ONSD to detect GCA, which will be evaluated using receiver operating characteristic curve analysis, with adjudicated GCA status serving as the reference standard. Secondary outcomes will address several complementary domains: its value for relapse monitoring will be assessed through time-dependent Cox proportional hazards models, examining whether baseline or longitudinal ONSD predicts relapse risk; intraobserver and interobserver reliability will be determined using intraclass correlation coefficients, providing quantitative estimates of measurement reproducibility; and its association with retinal findings will be evaluated by correlating ONSD measurements with ocular imaging and clinical retinal outcomes. Together, these analyses will comprehensively determine the diagnostic, prognostic and operational utility of ONSD in GCA.

Ethics and dissemination

The study has been peer-reviewed by the scientific committee and approved by the CIUSSS du Nord-de-l’Île-de-Montréal Research Ethics Board. Each participating site will obtain local ethics approval prior to enrolment. All participants will provide informed consent. Results will be disseminated through peer-reviewed publications, conference presentations and webinars.

Trial registration number

NCT05749094.

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.

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