Objective: Persistent efforts have been made to promote clinical trial transparency, which included encouraging trial registration and prospective registration, as well as protocol disclosure. This study aims to analyze the extent of registration, prospective registration and protocol disclosure in oncology clinical trials and their changing trends.
Study Design And Setting: All phase II and phase III oncology clinical trials published in 5 major journals, the Annals of Oncology, the Journal of Clinical Oncology, JAMA Oncology, The Lancet Oncology, and The New England Journal of Medicine, between January 2013 and December 2017, were included. Data on trial characteristics as well as registration status and availability of protocol and its location were collected.
Results: In total, 625 articles were included, 92% were registered, of which 76% were prospectively registered. Overall, 27% provided protocols. Increasing trends were observed in registration, prospective registration, and protocol disclosure (all P < 0.001). Studies with enrollment number larger than median number were more likely to be registered (adjusted odds ratio (aOR), 3.14 [95% confidence interval (CI), 1.21-8.15]) and to provide protocols (aOR, 3.84 [95% CI, 2.24-6.57]) than those with smaller enrollment number. Studies with nonindustry funding was less likely to be prospectively registered (aOR, 0.37 [95% CI, 0.25-0.55]) but more likely to provide protocols (aOR, 1.69 [95% CI, 1.13-2.52]) than those with industry funding only.
Conclusion: Although the rates of registration, prospective registration, and protocol disclosure of oncology trials have significantly increased over the years, there is still room for improvement.
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http://dx.doi.org/10.1016/j.jclinepi.2019.11.018 | DOI Listing |
J Neurosurg Spine
January 2025
6Presbyterian St. Lukes Medical Center, Denver, Colorado.
Objective: Malalignment following cervical spine deformity (CSD) surgery can negatively impact outcomes and increase complications. Despite the growing ability to plan alignment, it remains unclear whether preoperative goals are achieved with surgery. The objective of this study was to assess how good surgeons are at achieving their preoperative goal alignment following CSD surgery.
View Article and Find Full Text PDFPLoS One
January 2025
Faculty of Biology, School of Health Sciences, Medicine & Health, University of Manchester, Manchester, United Kingdom.
Background: Despite the comparatively high prevalence of possible sarcopenia among young-old adults in the community, there is currently no available and effective social media-based intervention to increase the awareness and change the behavior of the target population to prevent sarcopenia. Using co-design methodology, we developed a multicomponent intervention strategy of health education and exercise for sarcopenia prevention utilizing the TikTok platform.
Objectives: The primary purpose of this study is to examine the feasibility and acceptability of the social media-based intervention to enhance muscle function in community-dwelling young-old adults with possible sarcopenia.
Sports Med
January 2025
Department of Sports Medicine, Pontchaillou Hospital, Rennes, France.
Background: Although many studies have demonstrated a lower incidence of sudden cardiac arrest or death (SCA/D) in female athletes than in male, there is limited understanding of the specific underlying causes.
Objective: This systematic review aimed to assess the disparities in SCA/D incidence between male and female competitive athletes and explore the associated etiologies.
Methods: A comprehensive search was conducted for retrospective and prospective studies examining SCA/D incidence in male and female athletes.
Ann Hematol
January 2025
Division of Hematology & Medical Oncology, Department of Internal Medicine, Hanyang University Medical Centre, Hanyang University College of Medicine, Seoul, Republic of Korea.
Tuberculosis (TB) is associated with chronic inflammation, which has been implicated in the pathogenesis of various malignancies, including lung cancer. However, the relationship between TB and hematological malignancies like lymphoma remains less understood. This study aimed to investigate risks of incident malignant lymphoma according to previous TB infection in a large prospective cohort of 347,204 individuals.
View Article and Find Full Text PDFDan Med J
November 2024
Department of Otorhinolaryngology - Head and Neck Surgery and Audiology, Aalborg University Hospital.
Introduction: Shared decision-making (SDM) enables individually tailored treatment plans. This survey explored patients' and surgeons' perceptions of SDM in consultations on thyroid nodules. Furthermore, we aimed to explore possible discrepancies between the groups, identify factors influencing patients' perceived levels of SDM and evaluate decisional regret.
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