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Effect of Cervical Epidural STimulation After Neurological Damage: protocol for phase I/II open label controlled CE-STAND trial

Por: Mansour · N. · Keller-Ross · M. · Low · W. · Balser · D. Y. · Parr · A.
Introduction

Spinal cord injury (SCI) affects over 18 000 individuals annually, leading to significant motor and autonomic dysfunctions that reduce quality of life (QoL). Epidural spinal cord stimulation (eSCS) has shown potential in restoring function in chronic individuals with SCI. However, research on cervical and autonomic dysfunction-related SCI remains limited. This study will assess the safety and efficacy of eSCS in improving autonomic and volitional functions, as well as truncal stability, bowel, bladder and sexual function, and overall QoL.

Methods

The study is a phase I/II trial in which participants will serve as their own controls. The Abbott Eterna epidural stimulator system will be implanted, and assessments will occur every 3 months. The study will be conducted over a period of 4 years. A total of 36 participants will be enrolled and followed for 1 year.

Analysis

Bayesian optimisation will be used to determine the most effective stimulation settings, with 15 settings programmed at the end of each visit.

Ethics and dissemination

Food and Drug Administration and University of Minnesota Institutional Review Board approvals have been secured for the study. Interim reports will be made available through peer-reviewed journals, conference presentations and clinical network reporting.

Conclusion

CE-STAND (Cervical Epidural STimulation After Neurological Damage) seeks to advance SCI treatment by expanding eSCS applications in chronic cervical SCI, improving patient outcomes and reducing healthcare costs. Future studies could consider a larger sample size, long-term safety, matched-control and randomisation.

Trial registration number

NCT06410001

Gender dynamics in authorship of scientific publications in obstetrics and gynaecology: a 10-year bibliometric analysis of six high-impact journals

Por: Bobotis · S. · Stathi · D. · Verigos · E. · Geropoulos · G. · Arsenaki · E. · Paraskevaidi · M. · Tzafetas · M. · Mitra · A. · Kyrgiou · M. · Kechagias · K. S.
Objective

Although obstetrics and gynaecology (O&G) is a predominantly female specialty, previous studies have suggested that women remain under-represented in academic authorship. This study evaluates trends in female and male first and last authorship in six leading O&G journals (Human Reproduction Update, American Journal of Obstetrics and Gynecology, British Journal of Obstetrics and Gynaecology, Obstetrics and Gynecology, Gynecologic Oncology and Best Practice & Research Clinical Obstetrics & Gynaecology) between January 2013 and December 2023.

Methods

A bibliometric analysis was conducted using the Web of Science database. The gender of the first and last authors was determined using Genderize.io, with a probability threshold of ≥75% for classification. Binary logistic regression was performed to model the probability of authorship by gender across journals.

Results

Among 57 310 publications, 38 455 first (43.8% male and 56.2% female) and 38 950 last authors (58.6% male and 41.4% female) were identified and analysed. Over the past decade, female authorship has shown a clear upward trend, with first authorship increasing from 43% (1141/2636) in 2013 to 69% (2769/4036) in 2023, and last authorship increasing from 29% (770/2700) to 54% (2180/4047). First authorship was statistically more likely to be held by women in Human Reproduction Update (1.23, 95% CI 1.02 to 1.48), American Journal of Obstetrics & Gynecology (1.63, 95% CI 1.58 to 1.70) and Obstetrics & Gynecology (2.33, 95% CI 2.22 to 2.45). However, female last authorship was significantly more likely only in Obstetrics & Gynecology (1.21, 95% CI 1.16 to 1.27).

Conclusion

Despite an increasing trend in female representation in first and last authorships over the past decade, a significant gender disparity persists. While women now constitute the majority of first authors, last authorship remains disproportionately male, reflecting ongoing barriers to female leadership in O&G research. These findings highlight the need for targeted institutional efforts to promote gender equity in academic medicine.

Undisclosed financial conflicts of interest among physician-authors in leading US psychiatry journals: a cross-sectional study

Por: Gesel · F. · Baraldi · J. · Goldhirsh · J. · Piper · B. J.
Objective

To assess the prevalence and magnitude of undisclosed financial conflicts of interest (COIs) among physician-authors in high-impact US-based psychiatry journals.

Design

Cross-sectional study comparing the author self-reported disclosures to the journal(s) with payments mandatorily reported in the Open Payments database.

Methods

We examined original research articles published between 1 January 2020 and 31 December 2022 in two prominent US-based psychiatry journals: the American Journal of Psychiatry (AJP) and Journal of the American Medical Association Psychiatry (JAMA-PSY). Of 2872 publications screened, 74 articles authored by 27 eligible US-based physician-authors met the inclusion criteria.

Outcome measures

Total payments received by authors within the 3 years prior to publication and the proportion of undisclosed payments. Additional analyses assessed payment types (research vs general), author demographics and study characteristics associated with undisclosed COIs.

Results

US$4.54 million was paid to authors in the two journals, of which US$645 135 (14.2%) were undisclosed. AJP authors received US$205 943 (7.5% of total payments) in undisclosed payments, while JAMA-PSY authors received US$439 192 (24.8%). Research payments constituted 82.3% of all undisclosed payments. Total undisclosed payments among the top 10 highest-earning authors accounted for 84.8% (AJP) and 99.6% (JAMA-PSY) of all undisclosed payments to journals. Nearly all undisclosed payments, 96.2%, were made to authors conducting randomised controlled trials.

Conclusions

Substantial undisclosed financial COIs were identified among the top 10 earners in high-impact psychiatry journals. These findings highlight potential risks to research transparency and integrity. Further research is needed to evaluate the effectiveness of disclosure policies and develop mechanisms to mitigate COIs in psychiatric research.

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