• Construction and verification of a prediction model for gestational diabetes mellitus complicated with gestational hypertension based on a specialized disease research database.
    2 weeks ago
    To construct and validate a model for predicting the risk of gestational hypertension disorder (HDP) in pregnant women with gestational diabetes mellitus (GDM) and to explore the nonlinear association between key metabolic indicators and the risk of HDP.

    This study was a multicenter retrospective cohort study. Data were derived from the GDM-specific databases of multiple collaborating hospitals and included singleton pregnant women with GDM from May 29, 2018 to October 30, 2025. A total of 1,500 pregnant women were included in the analysis, of which 123 (8.2%) developed HDP. Using Boruta algorithm for feature screening, the optimal breakpoint determined based on restricted cubic spline (RCS) is used to convert continuous variables into binary variables, and a multivariable logistic regression is used to construct a prediction model; Apply RCS and segmented regression to analyze the nonlinear effects and thresholds of key continuous variables. Internal validation was conducted using Bootstrap resampling, and the clinical net benefit of the model was evaluated using decision curve analysis (DCA).

    The final prediction model included six variables: pre pregnancy BMI ≥ 25 kg/m 2 (OR = 1.92, 95% CI 1.28-2.87), assisted reproductive conception (OR = 1.80, 95% CI 1.07-3.04), history of adverse pregnancy and childbirth (OR = 1.54, 95% CI 0.97-2.47), HOMA-IR ≤ 2.6 (OR = 0.57, 95% CI 0.37-0.88), early pregnancy TG ≥ 2.867 mmol/L (OR = 1.81, 95% CI 0.91-3.59), and age ≥ 35 years (OR = 1.32, 95% CI 0.89-1.94). There is a significant non-linear correlation between HOMA-IR and triglyceride levels in early pregnancy and HDP risk, with thresholds of 2.600 and 2.867 mmol/L, respectively. When the threshold is below, the risk increases sharply with the increase of indicators. After internal validation, the final model had a corrected C-index of 0.644 (AUC = 0.665), with acceptable calibration accuracy. Decision curve analysis shows that when the decision threshold is between 2% and 18%, applying the model to guide clinical intervention can bring net benefits.

    We constructed a moderately‑performing HDP risk‑prediction model for GDM‑complicating pregnancies using accessible clinical variables for auxiliary risk stratification, with HOMA‑IR and TG exploratory thresholds needing prospective validation before clinical use.
    Diabetes
    Care/Management
  • Pasireotide-LAR and pegvisomant combination in resistant acromegaly: a case series of predominantly mammosomatotroph adenomas.
    2 weeks ago
    Long-term real-world data on concurrent pasireotide-LAR (PAS) and pegvisomant (PEGV) use in treatment-resistant acromegaly remain limited, especially for mammosomatotroph adenomas in younger adults. We report outcomes of six patients treated with this combination at a single tertiary pituitary center.

    IRB-approved retrospective case series. Baseline and follow-up biochemical, radiological, histopathological, treatment and safety outcomes were captured.

    Six patients (5 females, 1 male; age 15 to 44 years) with somatotroph (n = 2) or mammosomatotroph (n = 4) adenomas, all macroadenomas, received PAS (20 to 60 mg every 28 days) plus PEGV (60 to 280 mg/week) over a median of 3.3 years (range 0.5 to 5.9) after lack of disease control post-surgery despite multiple lines of medical therapy. All six maintained tumor stability and achieved normal IGF-1. One had biochemical escape after 9 months of biochemical control requiring a 2nd surgery and radiosurgery. One patient discontinued PEGV after 3 years due to injection site pain, 3 patients developed hyperglycemia in the pre-diabetes range; no hepatotoxicity, acute symptomatic biliary disease, or arrhythmias occurred.

    In this series of predominantly mammosomatotroph adenomas in younger adults, combination PAS plus PEGV offers potential durable biochemical control, tumor stability and PEGV dose reduction in treatment-resistant acromegaly. Glucose monitoring during treatment is essential as concomitant use of PEGV does not appear to mitigate PAS-induced glycemic deterioration. Larger prospective studies are needed to better define predictors of response.
    Cancer
    Access
    Care/Management
    Advocacy
  • [Spitz tumors].
    2 weeks ago
    Spitz tumors constitute a group of melanocytic neoplasms that can still pose a diagnostic challenge in individual cases.

    This article provides an overview of the current classification of Spitz tumors with a focus on histopathological aspects.

    The Spitz nevus and its variants, the atypical Spitz tumor/Spitz melanocytoma, and the Spitz melanoma were examined.

    With the increasing availability of information from histomorphology, immunohistochemistry, and, most recently, molecular pathology, the classification and associated terminology have changed in recent years.

    While pathologists largely agree on the diagnosis of small and "classic" cases of Spitz nevi in children or adolescents, there can be significant differences among pathologists regarding whether a lesion is assessed as benign or malignant in less typical cases. For more complex tumors, immunohistochemical and molecular characteristics provide support, both in distinguishing them from other types of nevi and as an essential basis for the classification of Spitz tumors themselves. Spitz melanoma is considered an intermediate stage in the progression of Spitz tumors. However, there remains a subset of Spitz tumors in which even experienced experts are unable to make a definitive morphological distinction between a nevus and a melanoma.
    Cancer
    Access
  • Fast, flexible analysis of differences in cellular composition with crumblr.
    2 weeks ago
    Changes in cell type composition play an important role in human health and disease. Recent advances in single-cell technology have enabled the measurement of cell type composition at increasing cell lineage resolution across large cohorts of individuals. Yet this raises new challenges for statistical analysis of these compositional data to identify changes in cell type frequency. We introduce crumblr ( DiseaseNeurogenomics.github.io/crumblr ), a scalable statistical method for analyzing count ratio data using precision-weighted linear mixed models incorporating random effects for complex study designs. Uniquely, crumblr performs statistical testing at multiple levels of the cell lineage hierarchy using a multivariate approach to increase power over tests of one cell type. In simulations, crumblr increases power compared to existing methods while controlling the false positive rate. We demonstrate the application of crumblr to published single-cell RNA-seq datasets for aging, tuberculosis infection in T cells, bone metastases from prostate cancer, and SARS-CoV-2 infection.
    Cancer
    Chronic respiratory disease
    Mental Health
    Access
    Care/Management
  • Low anterior resection syndrome and bowel dysfunction after ovarian cancer cytoreductive surgery: a narrative review.
    2 weeks ago
    Post-operative bowel dysfunction is an important survivorship issue in ovarian, fallopian tube, and primary peritoneal cancer. Cytoreductive surgery often includes rectosigmoid resection, placing patients at risk for low anterior resection syndrome, in which disordered bowel function after sphincter-preserving rectal resection impairs quality of life. Symptoms may precede surgery and worsen after cytoreduction. This review aims to synthesize the available evidence on low anterior resection syndrome and post-operative bowel dysfunction after ovarian cancer cytoreductive surgery and to define research priorities. Its presentation after ovarian cancer surgery may differ from that after rectal cancer surgery because of differences in disease distribution, pelvic dissection, radiotherapy exposure, systemic therapy, stoma practice, and baseline gastrointestinal symptoms. In some ovarian cancer cohorts, constipation-predominant dysfunction has been reported and requires complementary assessment because the low anterior resection syndrome score measures different symptom domains. Candidate factors include ultra-low rectal resection, low anastomotic height, multiple bowel anastomoses, extensive pelvic dissection, autonomic nerve disruption, para-aortic lymphadenectomy, recurrent disease, stoma-related factors, and pre-existing bowel dysfunction. Evidence remains largely observational and heterogeneous, with limitations related to inconsistent definitions, variable assessment timing, and a lack of standardized outcome measurement. Prevention should not compromise complete macroscopic tumor resection when rectosigmoid resection is oncologically required, but surgical planning should include preservation of rectal length and pelvic autonomic function when feasible, documentation of anastomotic height, and selective stoma use with restoration of continuity when appropriate. Management is largely extrapolated from the colorectal literature and should be symptom-directed, beginning with systematic assessment, stool regulation, diet, and medication, and escalating to pelvic floor rehabilitation, transanal irrigation, or specialist pelvic floor care when needed. Prospective ovarian cancer-specific studies with baseline assessment, standardized time points, and validated patient-reported outcomes are needed to estimate prevalence and guide survivorship care.
    Cancer
    Access
    Policy
  • [Study on the relationship between ultrasound-based response evaluation and pathological outcomes in neoadjuvant therapy for HER2-positive breast cancer].
    2 weeks ago
    Objective: To investigate the association between ultrasound response assessment during neoadjuvant therapy and pathological outcomes in patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Methods: This retrospective study included 609 patients with HER2-positive breast cancer who received neoadjuvant therapy at the Breast Center of Peking University Cancer Hospital between June 1, 2018, and December 31, 2024. Ultrasound response was assessed at cycles 2, 4, 6, and 8 according to the World Health Organization (WHO) response criteria and Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and categorized as clinical complete response (cCR), clinical partial response (cPR), clinical stable disease (cSD), or clinical progressive disease (cPD). Patients with cCR or cPR were classified into the response group, whereas those with cSD or cPD were classified into the poor-response group. Pathological complete response (pCR) and Miller-Payne (MP) grade were determined from surgical pathology. The χ2 test was used to analyze the associations of ultrasound response with pCR and MP grade. Receiver operating characteristic (ROC) curves and areas under the curves (AUC) were used to assess the performance of ultrasound response in predicting pCR. Results: The overall pCR rate was 67.5% (411/609), with rates of 68.7% (338/492) among patients receiving sequential anti-HER2 neoadjuvant therapy and 62.4% (73/117) among those receiving upfront anti-HER2 neoadjuvant therapy. Except for the WHO assessment at cycle 2, pCR rates differed significantly between the response and poor-response groups at all assessment time points according to both criteria (all P<0.05). The proportions of patients with MP grades 4-5 also differed significantly between the two groups at all assessment time points (all P<0.05). When ultrasound response according to each criterion was combined with clinicopathological factors, all AUC were<0.8, indicating poor predictive performance for pCR. In the upfront anti-HER2 therapy group, pCR rates differed significantly between the response and poor-response groups at cycles 2-6 (all P<0.05); in the sequential anti-HER2 therapy group, significant differences were observed at cycles 4-8 (all P<0.05). The pCR rate did not differ significantly between patients with SD accompanied by tumor enlargement and those with SD accompanied by tumor shrinkage (all P>0.05). Conclusions: During neoadjuvant therapy for HER2-positive breast cancer, a treatment response identified by ultrasound at cycle 2 in patients receiving upfront anti-HER2 therapy or at cycle 4 in those receiving sequential anti-HER2 therapy may be associated with pCR; however, ultrasound assessment has limited predictive value for pCR.
    Cancer
    Access
    Care/Management
    Advocacy
  • TACE combined with apatinib versus TACE alone for unresectable hepatocellular carcinoma in China: a cost-effectiveness and budget impact analysis.
    2 weeks ago
    To systematically evaluate the clinical efficacy, cost-effectiveness and impact on medical insurance budgets of transarterial chemoembolisation (TACE) combined with apatinib versus TACE alone for the treatment of unresectable hepatocellular carcinoma (uHCC) in China, from an integrated health technology assessment (HTA) perspective.

    An HTA incorporating evidence from a randomised controlled trial, a Markov model with parametric extrapolation of survival data over a lifetime horizon and a static 5-year budget impact model from the Chinese healthcare payer perspective.

    Analysis was conducted from the perspective of the Chinese public healthcare payer. Clinical evidence was derived from a multicentre, randomised, open-label, prospective, phase III trial conducted at 15 hospitals in China.

    The published trial included 196 patients with uHCC. Participants were predominantly male (overall 85%), with a mean age of 52.7 years in the combination group and 52.9 years in the TACE-alone group. All had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and were of Chinese ethnicity. The present analysis used the de-identified, aggregated data from this published trial.

    The experimental regimen comprised TACE (intra-arterial injection of lipiodol and epirubicin) combined with oral apatinib (500 mg/day, initiated 4 days after the first TACE). The control regimen was TACE alone.

    Clinical outcomes included median progression-free survival (PFS) and overall survival (OS). The primary economic outcome was the incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) gained. The primary budgetary outcome was the 5-year cumulative incremental expenditure on the national basic medical insurance fund.

    Clinical evidence showed that the combination therapy significantly prolonged median PFS (6.1 vs 3.4 months; HR 0.45, 95% CI 0.33 to 0.63; p<0.0001) and OS (28.9 vs 24.0 months; HR 0.55, 95% CI 0.40 to 0.77; p=0.0005). The economic evaluation indicated that at the 2021 centralised procurement price, the ICER for the combination regimen was US$42 864/QALY, exceeding the willingness-to-pay threshold (US$37 653/QALY); however, when applying the 2025 national centralised procurement price, the ICER decreased to US$30 650/QALY, rendering it cost-effective. Budget impact analysis results showed that under the base-case penetration rate (reaching 50% by year 5), the cumulative incremental expenditure over 5 years would be approximately US$365 million, a finding highly sensitive to both the penetration rate and drug price.

    The TACE-apatinib regimen provides clear clinical benefit for uHCC in China, but its cost-effectiveness and budget feasibility are contingent on drug price. Successful national centralised procurement is the key policy lever to enable value-based access, as demonstrated by this integrated evidence framework.

    ChiCTR1800018621.
    Cancer
    Access
    Care/Management
    Advocacy
  • SCOPES-II: short course of preoperative radiotherapy in head and neck, trunk and extremity soft tissue sarcomas - study protocol for a second randomised phase II clinical trial.
    2 weeks ago
    Soft tissue sarcomas (STS) are rare malignant tumours typically treated with surgery in combination with radiotherapy and/or chemotherapy. Conventional preoperative radiotherapy (25×2 Gy) prolongs treatment duration up to 3-5 months, which can substantially have an impact on the patient's burden. Moderate hypofractionated schedules (14-15×2.85-3 Gy) have shown comparable oncological outcomes and toxicity profiles to conventional treatment. Data on ultra-hypofractionated regimens, such as 5×6 Gy, suggest comparable outcomes. The SCOPES-II trial is designed to evaluate and compare a moderately hypofractionated radiotherapy regimen (14×3 Gy) with an ultra-hypofractionated schedule (5×6 Gy) in adults diagnosed with STS of intermediate or high histological grade.

    This international, multicentre, randomised phase II trial will include 150 adult patients with localised STS showing intermediate or high tumour grade, arising in the head and neck region, trunk, chest wall or limbs. Patients assigned to arm A will receive preoperative radiotherapy delivered as 14 fractions of 3 Gy, whereas those in arm B will undergo treatment consisting of 5 fractions of 6 Gy. In both treatment arms, surgical resection is planned approximately 6 to 8 weeks following completion of radiotherapy. The primary endpoint is the rate of postoperative wound-related complications occurring within 120 days after surgery. Secondary objectives comprise assessment of oncological efficacy, including local control and the development of distant disease, evaluation of late radiation-associated toxicities, patient-reported Health-Related Quality of Life (HRQoL) and an analysis of cost-effectiveness.

    Ethical approval for this trial has been obtained from the relevant Medical Ethics Committees (METc) in both the Netherlands (Medisch-Ethische Toetsingscommissie NedMec NL009842) and Poland (43/2026). Written informed consent will be obtained from all participants before inclusion in the study. The findings of this trial will be shared through publication in international peer-reviewed journals.

    NCT07071727.
    Cancer
    Access
    Care/Management
    Advocacy
  • Management of immune-related cutaneous adverse events associated with immune checkpoint inhibitors in patients with cancer: an evidence summary.
    2 weeks ago
    This study aims to systematically retrieve and synthesise the best available evidence on the management of immune-related cutaneous adverse events (ircAEs) associated with immune checkpoint inhibitors (ICIs) in patients with cancer, thereby providing evidence-based guidance for the development of assessment and management protocols in clinical practice.

    This study was conducted as an evidence summary following the evidence summary reporting standard of the Fudan University Center for Evidence-Based Nursing.

    Evidence was searched across clinical decision support resources, guideline repositories, professional society websites and bibliographic databases, including UpToDate, BMJ Best Practice, Joanna Briggs Institute (JBI), National Comprehensive Cancer Network, European Society for Medical Oncology, American Society of Clinical Oncology, Cochrane Library, Embase, PubMed, Web of Science and major Chinese databases. Searches were conducted up to 23 December 2025.

    Evidence sources concerning the assessment, prevention or management of ircAEs in adults aged ≥18 years receiving ICIs were eligible. Clinical practice guidelines, expert consensus statements, evidence summaries, systematic reviews, clinical decision support resources and relevant original studies, including observational and quasi-experimental studies, published in Chinese or English were considered for inclusion. Duplicate publications, superseded guidelines and evidence sources that did not meet the predefined methodological quality criteria were excluded.

    Two reviewers independently screened eligible evidence sources, extracted data and conducted methodological quality appraisal using design-appropriate tools, including the Appraisal of Guidelines for Research and Evaluation II and JBI critical appraisal instruments. Evidence was classified according to the JBI levels of evidence and evaluated for strength of recommendation using the feasibility, appropriateness, meaningfulness and effectiveness framework. Evidence with similar content was compared, integrated and synthesised into practice-oriented evidence statements, with disagreements resolved through discussion or consultation with a third reviewer.

    A total of 21 evidence sources were included, comprising nine clinical practice guidelines, five expert consensus statements, two systematic reviews, two evidence summaries, one observational study, one quasi-experimental study and one clinical decision support resource. 29 evidence statements were synthesised across seven domains: risk factor identification, assessment and diagnosis, severity-based treatment, supportive nursing care, follow-up management, patient education and healthcare professional training. The synthesised evidence emphasised baseline skin assessment and early recognition of ircAEs, standardised severity grading, severity-based treatment escalation, phenotype-oriented supportive skin care, structured follow-up, patient and caregiver education, and timely multidisciplinary referral for severe or complex cutaneous toxicities.

    The evidence provides a structured basis for standardising ircAEs screening, nursing assessment, symptom management, referral and follow-up in patients receiving ICIs. It may also support oncology nurses in strengthening patient and caregiver education, promoting timely symptom reporting and self-management and facilitating multidisciplinary referral for severe or atypical cutaneous toxicities.
    Cancer
    Access
    Care/Management
  • Effect of exercise on memory function and daily activities after colorectal cancer surgery: an exploratory secondary analysis from the randomised trial PHYSSURG-C.
    2 weeks ago
    To explore the effect of a short-term unsupervised exercise intervention on memory function and activities of daily living after surgery for colorectal cancer.

    Secondary analysis within a randomised controlled open label trial with central computerised 1:1 parallel allocation.

    One university and five regional hospitals in Sweden. Recruitment period 2015-2020.

    Moderately intense aerobic physical activity 30 minutes a day, 2 weeks before and 4 weeks after surgery.

    Patients with colorectal cancer undergoing elective curative surgery. Of the 761 randomised, 631 completed the study and were analysed (intervention 296/379, control 335/382). Median age 70 years, 61% men.

    Self-reported memory function and activities of daily living. Questionnaires were distributed at inclusion and at 4 weeks and 12 months postoperatively.

    There was no difference in self-reported memory function between the groups at 4 weeks. At 12 months, participants in the intervention group were less likely to report being told they had poor memory (OR 0.61, 95% CI 0.38 to 0.98). Regarding daily activities, participants in the intervention group were more likely to report a greater ability to shop for food or other necessities at 4 weeks (OR 1.53, 95% CI 1.07 to 2.20). No other significant differences were seen.

    This exploratory study with secondary data, nested in a multicentre randomised trial, found no substantial effects of a short-term unsupervised exercise intervention on memory function or the ability to perform daily activities in patients with colorectal cancer. An exercise intervention of this duration and intensity could be insufficient for improvement compared with standard care.

    NCT02299596.
    Cancer
    Access
    Care/Management
    Advocacy