Randomized controlled trials (RCTs) can produce valid estimates of the benefits and harms of therapeutic interventions. However, incomplete reporting can undermine the validity of their conclusions. Reporting guidelines, such as SPIRIT for protocols and CONSORT for results, have been developed to improve transparency in RCT publications. In this study, we report a corpus of 200 RCT publications, named SPIRIT-CONSORT-TM, annotated for transparency. We used a comprehensive data model that includes 83 items from SPIRIT and CONSORT checklists for annotation. Inter-annotator agreement was calculated for 30 pairs. The dataset includes 26,613 sentences annotated with checklist items and 4,231 terms. We also trained natural language processing (NLP) models that automatically identify these items in publications. The sentence classification model achieved 0.742 micro-F1 score (0.865 at the article level). The term extraction model yielded 0.545 and 0.663 micro-F1 score in strict and lenient evaluation, respectively. The corpus serves as a benchmark to train models that assist stakeholders of clinical research in maintaining high reporting standards and synthesizing information on study rigor and conduct.
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http://dx.doi.org/10.1038/s41597-025-04629-1 | DOI Listing |
Int J Behav Nutr Phys Act
March 2025
School of Health Sciences, College of Health, Medicine and Wellbeing, University of Newcastle, Callaghan, NSW, Australia.
Background: University students incur significantly elevated levels of stress compared to the general population and their non-student counterparts. Health risk behaviours are important modifiable determinants for the onset and aggravation of various mental health disorders, in which, university students generally exhibit poor engagement. Thus, this study aims to determine the efficacy of health behaviour interventions in relation to change in health behaviour and mental health outcomes, the impact of interventions (i.
View Article and Find Full Text PDFPurpose: The aim of this study was to compare the efficacy, clinical outcomes, and complications of cable-asisted bone transport (CASt) and circular external fixator-assisted bone transport (CEFt) methods in the management of bone defects of the tibia.
Methods: A retrospective analysis was conducted on 32 patients who underwent segmental bone transport for tibial bone defects between January 2006 and January 2020 and met the study inclusion criteria. Patients were categorized into two groups: CASt group (n = 16) and CEFt group (n = 16).
Eur J Obstet Gynecol Reprod Biol
March 2025
Department of Obstetrics, Gynecology and Reproductive Biology, College of Human Medicine, Michigan State University, MI, USA; Center for Health Policy and Public Health, College of Political, Administrative and Communication Sciences, Babeș-Bolyai University, Cluj-Napoca, Romania; Department of Public Health, College of Political, Administrative and Communication Sciences, Babeș-Bolyai University, Cluj-Napoca, Romania.
Aims: This study reports on the feasibility and preliminary efficacy of prenatal and postnatal couples-focused telephone counseling for pregnant tobacco smokers.
Design And Setting: This pilot randomized controlled trial (RCT) was conducted online in Romania and enrolled a total of 90 pregnant smokers and 77 of their life partners.
Participants: 90 adult pregnant smokers and 77 of their life partners were randomized either to (1) Motivation and Problem Solving (MAPS) telephone counseling (n = 45 pregnant smokers who received up to 8 pre/postnatal telephone counseling sessions and n = 40 partners who received up to 4 sessions) or (2) usual care (n = 45 pregnant smokers and n = 37 partners).
Medicine (Baltimore)
March 2025
Hunan Provincial Key Laboratory of Traditional Chinese Medicine Diagnostics, Hunan University of Chinese Medicine, Changsha, Hunan Province, China.
Background: The study aimed to conduct a network meta-analysis of randomized controlled trials (RCTs) to examine the effectiveness and safety of traditional Chinese patent medicine (TCPM), either used alone or combined with conventional treatment (CT) of chemical drugs, for treating chronic atrophic gastritis (CAG).
Methods: We searched the literature from database creation to December 2023; our primary endpoint was clinical response rate. Secondary outcome measures were the inhibition rate of Helicobacter pylori and clinical symptom score, including pain and noisy scores for the stomach, score for belch and acid reflux, score for the bitter taste and the dry throat, and safety according to total adverse events.
Cochrane Database Syst Rev
March 2025
Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.
Background: Multiple sclerosis (MS) is the most common neurological cause of disability in young adults. Off-label rituximab for MS is used in most countries surveyed by the International Federation of MS, including high-income countries where on-label disease-modifying treatments (DMTs) are available. This updates the 2021 version of the review.
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