暂无摘要。

UNASSIGNED: To develop text classification models for determining whether the checklist items in the CONSORT reporting guidelines are reported in randomized controlled trial publications.
UNASSIGNED: Using a corpus annotated at the sentence level with 37 fine-grained CONSORT items, we trained several sentence classification models (PubMedBERT fine-tuning, BioGPT fine-tuning, and in-context learning with GPT-4) and compared their performance. To address the problem of small training dataset, we used several data augmentation methods (EDA, UMLS-EDA, text generation and rephrasing with GPT-4) and assessed their impact on the fine-tuned PubMedBERT model. We also fine-tuned PubMedBERT models limited to checklist items associated with specific sections (e.g., Methods) to evaluate whether such models could improve performance compared to the single full model. We performed 5-fold cross-validation and report precision, recall, F1 score, and area under curve (AUC).
UNASSIGNED: Fine-tuned PubMedBERT model that takes as input the sentence and the surrounding sentence representations and uses section headers yielded the best overall performance (0.71 micro-F1, 0.64 macro-F1). Data augmentation had limited positive effect, UMLS-EDA yielding slightly better results than data augmentation using GPT-4. BioGPT fine-tuning and GPT-4 in-context learning exhibited suboptimal results. Methods-specific model yielded higher performance for methodology items, other section-specific models did not have significant impact.
UNASSIGNED: Most CONSORT checklist items can be recognized reasonably well with the fine-tuned PubMedBERT model but there is room for improvement. Improved models can underpin the journal editorial workflows and CONSORT adherence checks and can help authors in improving the reporting quality and completeness of their manuscripts.

暂无摘要。

BACKGROUND: Despite the critical importance of clinical trials to provide evidence about the effects of intervention for children and youth, a paucity of published high-quality pediatric clinical trials persists. Sub-optimal reporting of key trial elements necessary to critically appraise and synthesize findings is prevalent. To harmonize and provide guidance for reporting in pediatric controlled clinical trial protocols and reports, reporting guideline extensions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) guidelines specific to pediatrics are being developed: SPIRIT-Children (SPIRIT-C) and CONSORT-Children (CONSORT-C).
METHODS: The development of SPIRIT-C/CONSORT-C will be informed by the Enhancing the Quality and Transparency of Health Research Quality (EQUATOR) method for reporting guideline development in the following stages: (1) generation of a preliminary list of candidate items, informed by (a) items developed during initial development efforts and child relevant items from recent published SPIRIT and CONSORT extensions; (b) two systematic reviews and environmental scan of the literature; (c) workshops with young people; (2) an international Delphi study, where a wide range of panelists will vote on the inclusion or exclusion of candidate items on a nine-point Likert scale; (3) a consensus meeting to discuss items that have not reached consensus in the Delphi study and to \"lock\" the checklist items; (4) pilot testing of items and definitions to ensure that they are understandable, useful, and applicable; and (5) a final project meeting to discuss each item in the context of pilot test results. Key partners, including young people (ages 12-24 years) and family caregivers (e.g., parents) with lived experiences with pediatric clinical trials, and individuals with expertise and involvement in pediatric trials will be involved throughout the project. SPIRIT-C/CONSORT-C will be disseminated through publications, academic conferences, and endorsement by pediatric journals and relevant research networks and organizations.
CONCLUSIONS: SPIRIT/CONSORT-C may serve as resources to facilitate comprehensive reporting needed to understand pediatric clinical trial protocols and reports, which may improve transparency within pediatric clinical trials and reduce research waste.
BACKGROUND: The development of these reporting guidelines is registered with the EQUATOR Network: SPIRIT-Children ( https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials-protocols/#35 ) and CONSORT-Children ( https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#CHILD ).

The aim of this study was to explore adherence to the Consolidated Standards of Reporting Trials (CONSORT) reporting standards in abstracts of randomized controlled trials on glaucoma. A cross-sectional observational study was conducted on the aforementioned abstracts, indexed in MEDLINE/PubMed between the years 2017 and 2021. In total, 302 abstracts met the inclusion criteria and were further analyzed. The median score of CONSORT-A items was 8 (interquartile range, 7-10) out of 17 (47.0%). Most analyzed studies were conducted in a single center (80.5%) and the abstracts were predominantly structured (95.0%). Only 20.5% of the abstracts adequately described the trial design, while randomization and funding were described by 6.0% of the abstracts. Higher overall scores were associated with structured abstracts, a multicenter setting, statistically significant results, funding by industry, a higher number of participants, and having been published in journals with impact factors above four (p < 0.001, respectively). The results of this study indicate a suboptimal adherence to CONSORT-A reporting standards, especially in particular items such as randomization and funding. Since these factors could contribute to the overall quality of the trials and further translation of trial results into clinical practice, an improvement in glaucoma research reporting transparency is needed.

The Japanese macaque (Macaca fuscata) has become a key species for studying homosexual behavior over recent decades. With the non-conceptive nature, their same-sex consortships illustrate that individual partner preferences can exist beyond direct reproductive benefits or apparent sociosexual strategies. An open question is whether the behavior shared between partners in consortship directly affects their choice to remain with a partner. With this study, we examined behavioral aspects underlying consortship temporal patterns in these promiscuous and bisexual primates. While these patterns could be relevant in both homo- and heterosexual consortships, our study primarily focused on female-female pairs. We hypothesized that the stability of consortships (duration and occurrence) is influenced by a pair\'s sexual behavior, mutual sexual stimulation, and close affiliative inter-mount behaviors involving high-intensity body contact. A semi-free population of Japanese macaques was observed over one mating season. In total, 40 h of focal data on female-female consortship behaviors were analyzed. Forty-six percent of all sexually mature females engaged in homosexual interactions. Our behavioral analyses of female-female pairs found that close body contact, rather than grooming or sexual interactions, was correlated with the stability of homosexual consortships. The greater the amount of huddling and embracing a pair engaged in, the more likely they were to stay together and reunite again. However, the frequency of mounting, rubbing or thrusting had no discernable effect on consortship stability. The results of this study thus add important knowledge to partner qualities in promiscuous primates as well as to inter-group differences of homosexual behavior in Japanese macaques.

This study aimed to evaluate the reporting quality of randomized clinical trials (RCTs) in periodontology. Three leading periodontology journals, the Journal of Periodontology (JOP), the Journal of Clinical Periodontology (JOCP), and the Journal of Periodontal Research (JOPR), were selected for this investigation. The RCTs were identified by manually searching for human trial articles published in these three journals. Two authors independently conducted the literature search, and a pre-piloted extraction sheet was used to screen the potential RCTs. The CONSORT checklist guidelines were employed to calculate the score value. Intra-examiner reliability was assessed by scoring a random sample of 10% of the papers in a second round conducted by the first examiner three months after the initial data collection. A search of abstracts published over a five-year period yielded 176 articles that reported RCTs, accounting for 11.7% of all articles published in the three journals. The highest number of RCTs was published in 2020, and more than half of the included RCTs (51%) originated from Europe. Many of the analyzed RCTs inadequately reported almost half of the items on the CONSORT checklist. Furthermore, univariate analysis revealed significant associations between certain factors and the overall CONSORT score, such as publication in JOP (p = 0.048), publication year of 2019 (p = 0.041) and 2021 (p = 0.042), first author from North America (p = 0.016), and RCTs with more than six authors (p = 0.042). Clinical trial research in periodontics has made significant progress in the past five years. However, there is room for improvement in adhering to the CONSORT guidelines.

Creating effective dietary guidance requires a rigorous evidence base that is predominantly developed from robust clinical trials or large-scale cohort studies, with the quality of the data available depending on the completeness and accuracy of their reporting. An international group of academics from 14 institutions in 12 different countries and on 5 continents, working on behalf of the Federation of European Nutrition Societies within its \"Improving Standards in the Science of Nutrition\" initiative, reviewed the Consolidated Standards of Reporting Trials (CONSORT) statement checklist as it pertains to nutrition trials. This perspective piece documents the procedure followed to gain input and consensus on the checklist previously published by this group, including its presentation and interrogation at the International Union of Nutritional Sciences International Congress of Nutrition 2022 (IUNS-ICN 22), inputs from a survey of journal editors, and its piloting on 8 nutrition trials of diverse designs. Overall, the initiative has been met with considerable enthusiasm. At IUNS-ICN 22, refinements to our proposal were elicited through a World Café method discussion with participating nutrition scientists. The contributing journal editors provided valuable insights, and the discussion led to the development of a potential tool specific to assess adherence to the proposed nutrition extension checklist. The piloting of the proposed checklist provided evidence from real-life studies that reporting of nutrition trials can be improved. This initiative aims to stimulate further discussion and development of a CONSORT-nutrition-specific extension.

To describe randomized controlled trial (RCT) methodology reporting over time.
We used a deep learning-based sentence classification model based on the Consolidated Standards of Reporting Trials (CONSORT) statement, considered minimum requirements for reporting RCTs. We included 176,469 RCT reports published between 1966 and 2018. We analyzed the reporting trends over 5-year time periods, grouping trials from 1966 to 1990 in a single stratum. We also explored the effect of journal impact factor (JIF) and medical discipline.
Population, Intervention, Comparator, Outcome (PICO) items were commonly reported during each period, and reporting increased over time (e.g., interventions: 79.1% during 1966-1990 to 87.5% during 2010-2018). Reporting of some methods information has increased, although there is room for improvement (e.g., sequence generation: 10.8-41.8%). Some items are reported infrequently (e.g., allocation concealment: 5.1-19.3%). The number of items reported and JIF are weakly correlated (Pearson\'s r (162,702) = 0.16, P < 0.001). The differences in the proportion of items reported between disciplines are small (<10%).
Our analysis provides large-scale quantitative support for the hypothesis that RCT methodology reporting has improved over time. Extending these models to all CONSORT items could facilitate compliance checking during manuscript authoring and peer review, and support metaresearch.

UNASSIGNED: Adequate methods reporting in observational and trial literature is critical to interpretation and implementation.
UNASSIGNED: Evaluate methodology reporting adherence in the dermatology literature and compare this to internal medicine (IM) literature.
UNASSIGNED: We performed a cross-sectional review of randomly-selected dermatology and IM manuscripts published between 2014-2018. Observational and trial articles were retrieved from PubMed. The primary outcome was percent adherence to STROBE or CONSORT methods-related checklist items (methods reporting score, MRS). Secondary outcomes included the relationship between methods section length (MSL) and MRS. We additionally compared these with IM literature. MRS and MSL were compared by overall article length, checklist type, field, journal, study topic, and funding source. Comparisons were assessed using univariable and multivariable linear regression.
UNASSIGNED: We identified 389 articles (172 dermatology and 217 IM). Within dermatology, we identified 83 clinical trials and 89 observational studies. Mean MRS was 61.4 percent. A one word increase in MSL corresponded to a 0.02 percent increase MRS (β=0.02, 95% CI 0.01-0.03). Mean MRS was 12.8 percent lower in the dermatology literature compared with IM (β=-12.8%, -15.6-[-9.91]). Mean dermatology MSL was 345 words shorter (β=-345, -413-[-277]). Studies from JAMA Dermatology, Journal of Investigative Dermatology, and British Journal of Dermatology, with government funding, and having supplemental methods had higher mean MRS\'s.
UNASSIGNED: Methods reporting quality was low in dermatology. A weak relationship between MRS and MSL was observed. These data support enhancing researcher emphasis on methods reporting, editorial staff, and peer reviewers that more strictly enforce checklist reporting.