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Importance Currently, there are no standardized outcome domains or measures in clinical trials for facial aging. Heterogeneity in outcome domains and measurement instruments across clinical trials creates difficulty in directly comparing interventions, determining superior therapies, and developing high-quality meta-analyses. Objective To develop a core outcome set (COS) of essential domains to be reported in clinical trials evaluating the efficacy of interventions for facial aging. Evidence Review PubMed/Medline, Embase, Cochrane Central Register of Controlled Trials, and CINAHL were searched from September 2005 to September 2015. An updated search of the same databases was performed from September 2015 to February 2026. Studies were included if (1) they were randomized clinical trial or controlled clinical trial in design, (2) they assessed the efficacy or safety of an intervention for facial aging, (3) they were published in English, and (4) they involved human participants. Complementary sources, including patient interviews, were used to capture further relevant outcomes. Two rounds of Delphi surveys, followed by consensus meetings, were used to identify outcome domains considered most important by both patient and physician stakeholders. Findings The final COS consists of 6 outcome domains: (1) overall convenience of treatment; (2) time to return to normal work and social activity; (3) overall assessment of focused area of treatment (at the point in time when treatment is expected to provide peak benefit); (4) duration of treatment effect; (5) severity of persistent local or systemic adverse events, including pigmentary change, skin texture change, delayed healing, scarring, and serious adverse events; and (6) patient satisfaction with treatment. Conclusions and Relevance The 6 outcome domains identified through a Delphi consensus are recommended for reporting in future facial aging trials to ensure that outcomes that matter most to patients and clinicians are measured and that results are comparable across interventions.

Abstract Background Prosthetic joint infection (PJI) represents an important complication of total joint arthroplasty, affecting approximately 2% of patients. However, considerable heterogeneity in outcome definitions renders cross-study and clinical comparisons challenging. Methods We performed a meta-epidemiological study and systematic review of cohort studies and randomized controlled trial (RCTs) reporting clear definitions of PJI outcomes. Relevant data regarding outcome definitions of treatment success or failure were extracted and categorized into 7 outcome domains: clinical signs and symptoms, imaging, microbiology, mortality, antibiotics-related, surgical-related, and histology. A network plot was generated to visualize domains combinations. Data on patient-reported outcome measures (PROMs) were also collected. Based on these results, we finally proposed a working definition of PJI core outcome set. Results The literature search identified 7585 references, leading to 461 studies. The majority were retrospective (416/461, 90.2%), with limited representation of prospective studies (37/461, 8.0%) and RCTs (8/461, 1.7%). Outcome reporting was highly heterogeneous, with the clinical criterion being the most frequently used domain, combined with microbiological, surgical, and mortality-related outcomes. In contrast, histopathological, imaging, and antibiotic-related criteria were rarely reported. Thirty-six PROMs were included in only 111 (24.1%) studies, most commonly the Knee Society Score (26%) and Harris Hip Score (23%). Conclusions We showed substantial heterogeneity in PJI outcome definitions, with inconsistent reporting across key domains, limiting comparability and evidence synthesis. Standardized, consensus-based outcomes incorporating patient-reported and antibiotic-related measures are needed, and the proposed core outcome set may support harmonized research and clinical practice aligned with the new PJI definition.

Noncirrhotic portal hypertension has historically been described using heterogeneous and region-specific terminology—such as idiopathic portal hypertension (IPH), noncirrhotic portal fibrosis (NCPF), obliterative portal venopathy, and nodular regenerative hyperplasia—leading to substantial variability in diagnosis, reporting, and international research collaboration. Differences in guideline definitions from major societies (AASLD, EASL, and APASL), together with the presence of characteristic histologic lesions in patients without clinically overt portal hypertension, have further complicated disease classification. To address these challenges, a large, multisociety, international initiative was convened to harmonize nomenclature and diagnostic criteria. Representatives from liver, pathology, and pediatric hepatology societies across the Americas, Europe, and Asia participated in a structured consensus process that included specialized working groups and external Delphi validation. The initiative produced a globally harmonized and implementable diagnostic framework. Consensus was reached that the terms porto-sinusoidal vascular disorder (PSVD) and NCPF may be used interchangeably when identical diagnostic criteria are applied, and that they should be written as PSVD or NCPF . The diagnosis was defined as fundamentally clinicopathological, requiring integrated assessment. Core principles include the need for a high-quality liver biopsy (≥10 mm), mandatory exclusion of cirrhosis, and systematic exclusion of specific alternative conditions. Importantly, the consensus recognizes that PSVD or NCPF may be diagnosed even without clinical portal hypertension and may coexist with other liver diseases, provided cirrhosis is excluded. Standardized major and minor histologic criteria were developed collaboratively by expert pathologists and externally validated. Features of portal hypertension were harmonized into specific and nonspecific categories applicable to routine clinical practice. An integrated diagnostic scoring system incorporating histology, clinical features, associated conditions, and concommitant etiologies was developed and validated using the Delphi method. This consensus provides the first internationally endorsed, unified framework for the diagnosis of PSVD or NCPF. Its global implementation is expected to reduce diagnostic variability, improve comparability across regions, and facilitate the development of robust, internationally harmonized clinical and translational research cohorts.

ABSTRACT Background and Objective Despite growing interest in mindfulness‐based interventions for adolescents with chronic pain, the data have not been systematically summarized. We conducted a systematic review and meta‐analyses to estimate the effect of mindfulness‐based interventions on pain intensity, catastrophizing, acceptance and interference; functioning, quality of life, and anxiety and depression in youth with chronic pain. Databases and Data Treatment Electronic databases CINAHL, CCTR, Embase, Medline, PsycINFO, Scopus and Web of Science were systematically searched to January 2, 2025. Studies were included if they were in English, included > 5 patients, were not part of intensive interdisciplinary pain treatment and included pre‐post outcomes from mindfulness‐based interventions delivered to adolescents with chronic pain. Risk of bias was assessed with the Newcastle–Ottawa Scale. Results Fourteen studies including a total of 323 adolescents were identified. There were significant within group improvements in pain intensity, pain catastrophizing, pain acceptance, pain interference, functioning, depression, anxiety, and quality of life, with results maintained or increased at follow‐up effect sizes at follow‐up were moderate to large (e.g., quality of life SMD = 0.33; pain intensity SMD = −0.73; pain interference SMD = −1.44). Heterogeneity of results was generally moderate to high. Compared to standardized long interventions, variable length interventions showed greater pre‐post changes in functioning, pain intensity, and pain catastrophizing. The certainty in the estimates was generally low, due to risk of bias and pre‐post designs. Conclusions Although adolescents with chronic pain report improvements after participating in mindfulness‐based interventions, rigorous RCTs are needed to substantiate these results. Significance Statement Chronic pain in youth is common and difficult to treat. Previous interventions have largely been based on cognitive‐behavioural therapy and not successful for all. This is the first systematic review and meta‐analysis in paediatric chronic pain to focus on mindfulness‐based interventions, highlighting an alternative and potentially effective intervention approach. This study informs clinicians about an effective intervention approach and assists researchers in identifying gaps for further research.

Abstract Background Postoperative spinal implant infections (PSIIs) are a serious complication of instrumented spinal fusion. Although debridement with implant retention is standard for early infection, the optimal duration of antimicrobial therapy remains uncertain. Methods We conducted a multicenter retrospective cohort study across 10 US academic centers, including adults with early PSII (≤90 days after fusion surgery) from 2017 to 2021. We excluded patients who experienced treatment failure within 6 weeks of debridement. The primary outcome was treatment failure. Antibiotic therapy effect was analyzed as a time-varying exposure using adjusted Cox proportional hazards models. Secondary analyses included 12-week landmark and clone-censor-weighted models to compare durations ≤ 12 weeks versus >12 weeks. Results A total of 116 patients out of 499 (23.2%) experienced treatment failure during a median follow-up of 3.2 years. Among patients who remain failure-free 6 weeks from debridement, being on antibiotics was not associated with treatment failure (adjusted hazard ratio [aHR] 0.71; 95% CI .48–1.07; P = .10). In a 12-week landmark analysis limited to 359 patients who were not on indefinite suppressive antibiotic therapy, treatment durations > 12 weeks did not significantly reduce the risk of failure (aHR 1.01; 95% CI .62–1.64; P = .99). Results were consistent in the clone-censor-weight sensitivity analysis (aHR 0.85; 95% CI .62–1.16; P = .30). Conclusions Prolonged antibiotic therapy was not associated with improved outcomes in early PSII managed with debridement and implant retention. These results support shorter, individualized antibiotic courses in patients with adequate surgical source control.

Abstract Background Community-acquired pneumonia (CAP) is a significant public health concern associated with increased rates of hospital admissions and mortality. The purpose of the current study was to compare beta-lactam plus azithromycin or doxycycline vs fluoroquinolones in adults hospitalized with CAP. Methods We searched several databases from inception to 10 June 2024. Two reviewers independently screened, selected, and extracted data. Disagreements were resolved by consensus or a third reviewer. Study quality was assessed in duplicate with the Cochrane Risk of Bias 2 for randomized studies and the Newcastle-Ottawa Scale for nonrandomized studies. Meta-analysis was conducted by a random effect model when feasible. Network meta-analysis was performed to compare direct and indirect evidence. The GRADE approach (Grading of Recommendations Assessment, Development, and Evaluation) was followed to rate the certainty of evidence. Results Twenty studies were included (20 beta-lactam + azithromycin, 7 beta-lactam + doxycycline, 12 levofloxacin, and 4 moxifloxacin): 6 were randomized, enrolling 861 participants (mean age, 61.8 years; 43.2% women), and 14 were nonrandomized, enrolling 185 928 participants (mean age, 65.2 years; 42.9% women). Direct comparison and network meta-analysis results showed no statistically significant differences and likely equal effectiveness between beta-lactam + azithromycin and beta-lactam + doxycycline in terms of in-hospital mortality, need for intensive care unit admission or invasive mechanical ventilation, or safety outcomes including Clostridioides difficile infection and QT prolongation. Conclusions The current evidence demonstrated no likely difference in outcomes between azithromycin and doxycycline in adults hospitalized with CAP receiving beta-lactam. Head-to-head randomized clinical trials are needed to validate these results.

Objective To examine the potential errors of a general large language model (LLM) (ie, Claude 3.5 Sonnet) on data extraction from randomised controlled trials (RCTs). Design and setting An empirical study comparing Claude 3.5 Sonnet extractions against a human-performed verification dataset. The extraction tasks for Claude 3.5 Sonnet were based solely on original RCT portable document format (PDF) files. For PDFs that could not be directly extracted by Claude 3.5 Sonnet, optical character recognition was employed to convert them into text format before extraction. Participants A random sample of 664 trials was selected from a well-established trial bank and a final data pool was established based on rigorous manual cross-checking as a reference standard. Data sources PubMed, EMBASE, Scopus, Web of Science (all databases) and the Cochrane Central Register of Controlled Trials (CENTRAL) up to February 2023. Eligibility criteria for selecting studies RCTs on children involving medication and adverse events. Main outcome measures Claude 3.5 Sonnet was applied to extract the basic information (eg, trial design, population information and source of funding) and adverse outcomes (ie, name of adverse events, number of events). Claude 3.5 Sonnet outputs were compared against the final data pool and all errors were recorded. Results are presented as error rates and with 95% CI, estimated using a generalised linear mixed model. Results For the 664 trials, a total of 23 069 data cells were extracted via Claude 3.5 Sonnet, with 10 624 for basic information and 12 445 for adverse outcomes. The overall error rate for data extraction was 6.6% (95% CI 5.4% to 8.2%), with 5.7% (95% CI 5.2% to 6.1%) in basic information and 7.6% (95% CI 4.9% to 11.8%) in adverse outcomes. When stratified the 1542 total errors by error types, misallocation (assigning data to incorrect fields; 57.1%, 881/1542) and missed or omitted data (incomplete extraction of available data; 23.2%, 357/1542) accounted for the two most frequent errors, with misallocation occurring more in basic information (53.3%, 470/881), while missed or omitted data occurred more in adverse outcomes (96.1%, 343/357). Post hoc analysis examining the association between trial reporting quality (assessed using Consolidated Standards of Reporting Trials (CONSORT) 2025 and LLM data extraction error rates indicated that higher CONSORT adherence was associated with lower extraction error rates. Conclusions The data extraction error of Claude was relatively low, but it alerts LLM applications in evidence synthesis. Detailed checking for LLM outputs should be the primary consideration for evidence synthesisers.

Objectives This study aims to compare the reliability and accuracy of three large language models (LLMs) (Claude, Gemini and GPT) in assessing the risk of bias of nonrandomised studies using the ROBINS-I tool. Methods and analysis We conducted a secondary analysis of 171 nonrandomised studies previously assessed with Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool by two independent human review teams. Only studies with concordant human domain-level ratings were included. Each study was independently assessed twice by Claude, Gemini and Generative Pre-trained Transformer (GPT) using agent-based structured implementations of the ROBINS-I tool. Reliability (agreement between two runs of the same LLM) was evaluated using percent agreement and Gwet’s AC1. Accuracy (agreement with human reviewers) was assessed only for studies with consistent LLM ratings, using the same metrics. Results Claude demonstrated high reliability across all domains (79.5–98.0% agreement, AC1=0.729–0.975). Gemini showed moderate-to-high reliability (agreement 76.7–100%, AC1=0.680–1.0). GPT exhibited lower reliability overall, though domain-level agreement ranged from 70.9–95.6% (AC1=0.596–0.944). In terms of accuracy, Claude showed overall poor agreement with human reviewers (14.4–68.5% agreement; low AC1 values). Gemini demonstrated moderate-to-high accuracy in several domains, including deviations from intended interventions (79.6%, AC1=0.848) and measurement of outcomes (73.9%, AC1=0.702), with the highest overall agreement (40.0%, AC1=0.672). GPT showed variable accuracy, with the highest in measurement of outcomes (62.8%, AC1=0.571) and classification of interventions (57.8%, AC1=0.498), but poor performance in selection (14.3%, AC1 = −0.041) and overall agreement (23.0%, AC1=0.267). Conclusions Claude was internally consistent but poorly aligned with human reviewers. Gemini achieved both high reliability and moderate-to-high accuracy, whereas GPT had lower reliability and mixed accuracy. Current off-the-shelf LLMs cannot reliably perform ROBINS-I risk of bias assessments.

Abstract Background Metabolic dysfunction–associated steatotic liver disease (MASLD) is increasingly recognized among people with human immunodeficiency virus (PWH), which is likely related to metabolic alterations and fat redistribution. Anthropometric measures such as body mass index (BMI) and waist circumference (WC) are commonly used for assessing metabolic risk. However, their predictive accuracy for MASLD in this population remains uncertain. Method This multicenter cross-sectional study enrolled adults with HIV who underwent transient elastography with controlled attenuation parameter (CAP) measurement. Anthropometric and metabolic indices, including BMI, WC, hip circumference, waist-to-hip ratio (WHR), and visceral adiposity index (VAI), were collected from the study participants. Receiver operating characteristic (ROC) curve analyses were performed to determine the diagnostic performance of these indices for detecting hepatic steatosis, defined as CAP value of ≥248 dB/m. Analyses were stratified by sex assigned at birth. Results Altogether, 256 participants were included. WC demonstrated the numerically highest discrimination for CAP-defined steatosis (area under the ROC curve 0.769), followed by BMI and hip circumference, whereas WHR and VAI showed weaker performance. In sex-stratified analyses, WC remained the numerically highest-performing measure among males, whereas BMI, WC, hip circumference, and VAI showed similar discrimination among females. Conclusions Simple anthropometric measures, particularly WC, show fair ability to discriminate CAP-defined hepatic steatosis in PWH and may facilitate targeted fatty liver screening in routine HIV care.