方法与临床研究雷达（2026-09-11）
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1. Cost-effectiveness of nicotine metabolite ratio-guided smoking cessation therapy in China: a hybrid decision-analytic modeling study based on real-world data.
主题：因果推断、RWE 与卫生经济学
相关性分数：8
期刊：Journal of medical economics
公开日期：2026-09-01（电子公开）
期刊卷期日期：2026-Dec
内容状态：待评估
为什么值得看：包含可供初筛的摘要；已识别电子公开日期；通过方法学信号门槛；仍需阅读全文评价适用性与证据质量。
AIMS: To estimate the projected cost-effectiveness of NMR-guided metabolism-informed care (MIC) compared with standard care (SC) for smoking cessation in China.
MATERIALS AND METHODS: A 24-week decision tree was linked to an annual semi-Markov cohort model that followed individuals from age 45 to age 100. Clinical inputs were informed by the China National Tobacco Cessation Cohort Study. Stabilized inverse probability of treatment weights were estimated using a multinomial propensity-score model, trimmed at the 1st and 99th percentiles, and analyzed using robust sandwich variance estimators. Under MIC, fast metabolizers (NMR ≥ 0.31) received varenicline, while slow metabolizers (NMR < 0.31) received either nicotine replacement therapy (NRT) or bupropion. Costs were expressed in 2023 Chinese yuan (CNY), and costs and health outcomes were discounted at 5% annually.
RESULTS: Over the lifetime model horizon, SC generated 13.125 QALYs per person at a total cost of CNY 40,832.29. Both MIC medication-cost scenarios generated an additional 0.003 QALYs. MIC-Bupropion cost CNY 41,033.81 and yielded an ICER of CNY 67,930.00 per QALY gained versus SC. The corresponding deterministic INMB versus SC was CNY 63.57 at the primary threshold. In the fully incremental analysis, MIC-NRT was strictly dominated by MIC-Bupropion. At CNY 89,358.00 per QALY, MIC-Bupropion had the highest net monetary benefit in 50.4% of probabilistic simulations.
LIMITATIONS: Findings depended on observational clinical inputs, literature-derived long-term parameters, and structural assumptions, and did not fully capture all smoking-related diseases, adherence, adverse effects, or implementation costs.
CONCLUSIONS: MIC-Bupropion showed favorable expected economic performance relative to SC, whereas MIC-NRT was strictly dominated. Further comparative-effectiveness, budget-impact, and implementation studies are warranted before routine adoption.
Medicines can help people quit smoking, but the right choice varies from person to person. The nicotine metabolite ratio (NMR)-a lab test that measures how quickly the body breaks down nicotine-could help doctors match each smoker to the most appropriate medication.We used real-world data from 1,100 people who sought smoking cessation treatment in China to estimate the costs and health benefits of NMR-guided care compared with standard care. Under NMR-guided strategy, fast metabolizers received varenicline, while slow metabolizers received either nicotine replacement therapy (NRT) or bupropion, resulting in two medication-cost scenarios for this economic evaluation. Because treatment assignment in the cohort was not randomized, we adjusted for measured differences between medication groups. The economic model assigned NRT and bupropion the same probability of quitting smoking.Under this assumption, the two MIC medication-cost scenarios produced the same health gains but differed in cost. The MIC-Bupropion scenario was less costly than MIC-NRT and had a cost per additional quality-adjusted life-year below the primary willingness-to-pay threshold. However, the MIC-bupropion scenario had the highest net monetary benefit in only 50.4% of probabilistic simulations at that threshold, indicating substantial decision uncertainty.This analysis estimated outcomes per person treated and provided an initial economic basis for considering NMR-guided care in China. Further studies on comparative effectiveness, budget impact, and real-world implementation are required. Nonetheless, the results suggest that NMR-guided care, especially using bupropion for slow metabolizers, is a promising and potentially cost-effective strategy worthy of further investigation and pilot implementation.
2. Sample-size justification, differential post-randomization exclusion, and multiplicity in a randomized trial of epidural versus wound catheter analgesia after pancreatoduodenectomy.
主题：临床试验方法与统计实践
相关性分数：6
期刊：Pancreatology : official journal of the International Association of Pancreatology (IAP) … [et al.]
公开日期：2026-09-09（电子公开）
期刊卷期日期：2026-Sep-09
内容状态：待评估
为什么值得看：暂缺摘要，需回到 PubMed 核验；已识别电子公开日期；通过方法学信号门槛；仍需阅读全文评价适用性与证据质量。
3. Application of competing risks models in cardiovascular mortality research: findings from the Tehran lipid and glucose study.
主题：生存与复杂事件结局方法
相关性分数：6
期刊：Journal of diabetes and metabolic disorders
公开日期：2026-07-21（电子公开）
期刊卷期日期：2026-Dec
内容状态：待评估
为什么值得看：包含可供初筛的摘要；已识别电子公开日期；通过方法学信号门槛；仍需阅读全文评价适用性与证据质量。
PURPOSE: Cardiovascular diseases (CVD) are a leading cause of mortality in Iran and globally. This study aimed to provide more accurate estimates of associations between risk factors and CVD mortality by applying competing risk models within the Tehran Lipid and Glucose Study cohort.
METHODS: In this prospective analysis, 7,529 individuals aged ≥ 30 years without prevalent CVD were followed for a median of 19.87 years. The primary outcome was CVD mortality (n = 311), with non-CVD death as the competing event (n = 592). Analyses were stratified by sex and age (< 65 vs. ≥65 years). Cause-specific and Fine-Gray models estimated hazard ratios for diabetes, hypertension, hypercholesterolemia, smoking, and body mass index.
RESULTS: Diabetes and hypertension were the strongest predictors of CVD mortality across most subgroups. In the Fine-Gray model, diabetes showed the greatest impact in women < 65 years (HR: 4.83, p < 0.001), while hypertension showed the strongest association in women ≥ 65 years (HR: 3.32, p < 0.001). Hypercholesterolemia was associated with increased CVD mortality exclusively in women < 65 years (HR: 1.79, p = 0.02). Body mass index showed no significant association.
CONCLUSION: Diabetes and hypertension are the predominant risk factors for CVD mortality in the presence of competing risks, with effect magnitudes varying by sex and age. Applying competing risk models is essential for accurate risk estimation and targeted prevention in populations with high competing mortality burden.
4. A pragmatic randomized trial to evaluate the vaccine effectiveness of bivalent RSV prefusion F vaccine for preventing RSV hospitalizations in adults (DAN-RSV): Trial design update.
主题：临床试验方法与统计实践
相关性分数：6
期刊：American heart journal
公开日期：2026-06-01（电子公开）
期刊卷期日期：2026-Oct
内容状态：待评估
为什么值得看：包含可供初筛的摘要；已识别电子公开日期；通过方法学信号门槛；仍需阅读全文评价适用性与证据质量。
BACKGROUND: Respiratory syncytial virus (RSV) is a major cause of respiratory morbidity in adults, particularly among older individuals and those with comorbidities. The DAN-RSV trial was initiated to evaluate bivalent RSV prefusion F (RSVpreF) vaccine effectiveness in preventing RSV-related hospitalizations.
METHODS: DAN-RSV is a large-scale, pragmatic, randomized clinical trial that enrolled participants during the 2024/2025 (Danish adults aged ≥60 years) and 2025/2026 (adults aged ≥18 years in Denmark and Galicia, Spain) Northern hemisphere winter seasons. In Denmark, nationwide registries and the national electronic messaging system were used to identify and recruit eligible citizens; individuals could provide electronic informed consent remotely or in-person. In Galicia, participants were recruited via text message invitations and consented on-site.
RESULTS: During the initial 2024/2025 season, 131,379 Danish adults aged ≥60 years were enrolled. Following lower-than-expected event accrual and expansion of the EU indication to adults 18 years and older, the trial was extended to continue enrollment of adults aged ≥18 years across Denmark and Galicia, Spain during the 2025/2026 RSV season. Key protocol updates include expansion of the eligibility criteria to adults aged ≥18 years, inclusion of an additional study site within the integrated public healthcare infrastructure of Galicia, Spain, and an increase in the planned sample size to up to approximately 690,000 participants across both seasons. The randomization strategy (1:1 to RSVpreF vaccine or no vaccine), primary endpoint (RSV-related respiratory tract disease hospitalization), and statistical framework, including intention-to-treat analyses and hierarchical testing, remain unchanged.
CONCLUSION: The extension of the DAN-RSV trial is expected to improve statistical precision, enhance generalizability, and strengthen the robustness of the effect estimates. The updated design will provide reliable randomized evidence on bivalent RSVpreF vaccine effectiveness to inform clinical and public health decision-making.
5. Covariate-adaptive randomization with dropouts.
主题：临床试验方法与统计实践
相关性分数：5
期刊：Statistical methods in medical research
公开日期：2026-09-10（电子公开）
期刊卷期日期：2026-Sep
内容状态：待评估
为什么值得看：包含可供初筛的摘要；已识别电子公开日期；通过方法学信号门槛；仍需阅读全文评价适用性与证据质量。
While clinical trials are often regarded as the gold standard by medical researchers and regulatory agencies, the statistical properties of typical randomized controlled trials heavily depend on large sample sizes, which may not always be achievable due to budget constraints or other practical limitations. To address this issue, adaptive designs have gained increasing attention since the 1970s. These designs incorporate modifications in trial procedures or statistical methodologies, aiming to fulfill study objectives more efficiently using smaller sample sizes and shorter durations compared to traditional clinical trials. Specifically, covariate-adaptive designs are developed to reduce the risk of significant covariate imbalances among treatment groups, particularly in studies with limited sample sizes. Additionally, patient dropout during trials significantly impacts statistical inference regarding treatment effects and diminishes statistical power. Ignoring dropout events can result in undesirable participant allocation and substantial treatment imbalances. In this article, we propose novel strategies that explicitly incorporate dropout information into covariate-adaptive randomization. We thoroughly investigate the statistical properties of covariate-adaptive designs adjusted for dropouts. Extensive simulation studies highlight the advantages of the proposed approaches. Our research lays a robust foundation for future developments in covariate-adaptive randomization, specifically addressing dropout challenges.
6. Cost-effectiveness analysis of elranatamab versus physician’s choice of treatment (non-BCMA-directed regimens) in patients with triple class exposed multiple myeloma in Japan.
主题：因果推断、RWE 与卫生经济学
相关性分数：5
期刊：Journal of medical economics
公开日期：2026-09-08（电子公开）
期刊卷期日期：2026-Dec
内容状态：待评估
为什么值得看：包含可供初筛的摘要；已识别电子公开日期；通过方法学信号门槛；仍需阅读全文评价适用性与证据质量。
AIM: To evaluate the cost-effectiveness of elranatamab versus physician’s choice of treatment (PCT) for patients with triple class exposed multiple myeloma in Japan.
MATERIALS AND METHODS: A cost-effectiveness analysis was conducted comparing elranatamab with PCT using a partitioned survival model with three health states from the Japanese public healthcare payer perspective. A weekly cycle length and a 25-year lifetime horizon were applied, with costs and health outcomes discounted at 2% annually in accordance with Japanese HTA guidelines. Clinical inputs for elranatamab were derived from the phase 2 MagnetisMM-3 trial. Comparative effectiveness versus PCT was estimated using an unanchored matching-adjusted indirect comparison (MAIC) with the prospective real-world LocoMMotion study. Utility values were calculated by applying the Japanese value set to EQ-5D-5L data collected in MagnetisMM-3. Scenario analyses were performed using MAIC-based comparisons versus teclistamab and idecabtagene vicleucel (ide-cel).
RESULTS: In the base-case analysis, elranatamab increased quality-adjusted life-years (QALYs) compared with PCT (2.59 vs 0.82) at a higher total cost (JPY 36,901,695 (USD 246,570) vs 30,899,696 (USD 206,466)), resulting in an incremental cost of JPY 6,001,999 (USD 40,104) and an incremental QALY gain of 1.77. The incremental cost-effectiveness ratio (ICER) was JPY 3,394,966 (USD 22,684) per QALY, remaining within cost-effectiveness thresholds in Japan. Sensitivity analyses demonstrated the robustness of the base-case results. In scenario analyses, elranatamab was dominant versus teclistamab and ide-cel.
LIMITATIONS: Limitations include reliance on the clinical opinion of a single hematology expert for Japanese clinical practice patterns, extrapolation beyond observed trial follow-up, and inherent constraints of MAIC due to the lack of head-to-head trials.
CONCLUSION: From the healthcare payer perspective, elranatamab was cost-effective versus PCT in the base case and scenario analyses, with ICERs consistently below commonly accepted thresholds in Japan; contingent on the unanchored MAIC and long-term extrapolation, this should be interpreted with caution.
7. Clinico-genomic risk stratification for biomarker-enriched trial design in poor-prognosis metastatic castrate-resistant prostate cancer (mCRPC).
主题：临床试验方法与统计实践
相关性分数：5
期刊：The journal of liquid biopsy
公开日期：2026-08-14（电子公开）
期刊卷期日期：2026-Sep
内容状态：待评估
为什么值得看：包含可供初筛的摘要；已识别电子公开日期；通过方法学信号门槛；仍需阅读全文评价适用性与证据质量。
BACKGROUND: An integrated prognostic risk-score (RS) based on prognostic clinical factors and plasma copy number alterations (CNAs) across independent metastatic castration-resistant prostate cancer (mCRPC) cohorts was applied as a classifier to guide development of biomarker-enriched clinical trial designs.
DESIGN: Plasma CNAs prognostic for survival were combined into a prognostic score and integrated with clinical prognostic factors to derive an integrated RS in three independent mCRPC cohorts. Biomarker-enrichment trial designs were simulated across a spectrum of enrichment fractions and enrichment thresholds for the RS to consider 1:1 randomization of high RS patients to a study treatment arm or to receive standard treatment, with either a two or a three-year follow-up. The enrichment strategy was applied to improve the trial’s ability to detect survival benefit at a Hazard Ratio 0.70; 80% power. Design trade-offs were assessed between the number of “high-risk” patients screened versus enrolled under varying enrichment thresholds and degrees of enrichment of the RS.
RESULTS: Pooled mCRPC patients (N = 561) showed RS values from 0.243 to 3.924 and a RS ≥ 1 (60th percentile) was associated with shorter survival. Elastic net models for 2- and 3-year survival were developed. At a threshold ≥1 with 2-year follow-up, a hybrid biomarker-enriched design (50% unselected, 50% high-risk) required screening 768 patients to enroll 219 per arm (n = 438), while maintaining adequate power.
CONCLUSION: An integrated clinico-genomic classifier can guide an mCRPC enrichment strategy by enriching a cohort with 50% short-survival patients balancing sample size and screening needs to achieve adequate power in a biomarker-enriched design.
8. Cost-effectiveness of finotonlimab plus bevacizumab versus sorafenib as first-line therapy in unresectable hepatocellular carcinoma in China.
主题：因果推断、RWE 与卫生经济学
相关性分数：5
期刊：Human vaccines & immunotherapeutics
公开日期：2026-07-27（电子公开）
期刊卷期日期：2026-Dec-31
内容状态：待评估
为什么值得看：包含可供初筛的摘要；已识别电子公开日期；通过方法学信号门槛；仍需阅读全文评价适用性与证据质量。
Hepatocellular carcinoma (HCC) imposes a substantial health burden in China. Finotonlimab plus bevacizumab recently prolonged progression-free survival (PFS) and overall survival (OS) vs. sorafenib, but its economic value remains unknown. Here we evaluated the cost-effectiveness of finotonlimab plus bevacizumab vs. sorafenib from the Chinese healthcare system perspective. Parametric survival models were fitted to extrapolate PFS and OS. Total costs, life-years (LYs), quality-adjusted life-years (QALYs), incremental cost-effectiveness ratios (ICERs), incremental net monetary benefit (INMB), and incremental net health benefit (INHB) were estimated at a willingness-to-pay (WTP) threshold of $27,906 per QALY. Uncertainty was evaluated by one-way and two-way sensitivity analyses, probabilistic sensitivity analysis (PSA), subgroup analyses, scenario analyses, and price simulations. In the base-case analysis, sorafenib yielded 1.74 LYs and 1.25 QALYs at a total cost of $10,303.10, whereas finotonlimab plus bevacizumab yielded 3.01 LYs and 2.18 QALYs at a total cost of $58,595.49. Compared with sorafenib, the combination increased costs by $48,292.39 and generated gains of 1.27 LYs and 0.93 QALYs, resulting in ICERs of $38,203.46 per LY and $51,899.31 per QALY. INMB (-$22,325.82) and INHB (-0.80 QALYs) were negative. Sensitivity analyses identified PFS utility and bevacizumab cost as key drivers, but all ICERs remained above the WTP threshold. In PSA, the mean ICER was $50561.81 per QALY, and the probability of cost-effectiveness was 0% at the prespecified threshold. Based on the assumptions and inputs used in the present model, finotonlimab plus bevacizumab was unlikely to be cost-effective compared with sorafenib at the prespecified WTP in China.
9. Ultrasound-Guided Infraspinatus-Teres Minor Interfascial Block versus Interscalene Brachial Plexus Block for Analgesia After Arthroscopic Shoulder Surgery: A Randomized Non-Inferiority Clinical Trial.
主题：临床试验方法与统计实践
相关性分数：4
期刊：Drug design, development and therapy
公开日期：2026-09-03（电子公开）
期刊卷期日期：2026
内容状态：待评估
为什么值得看：包含可供初筛的摘要；已识别电子公开日期；通过方法学信号门槛；仍需阅读全文评价适用性与证据质量。
BACKGROUND: This randomized non-inferiority trial was designed to verify whether ultrasound-guided infraspinatus-teres minor interfascial block (ITMB) could produce non-inferior postoperative analgesia in adult patients undergoing arthroscopic shoulder surgery compared with ultrasound-guided interscalene brachial plexus block (ISB), while also comparing the early respiratory safety profiles and postoperative adverse events of the two techniques.
METHODS: This trial adopted a two-arm parallel-group design with blinding for participants and all outcome assessors. A total of 82 eligible patients were randomly assigned 1:1 to receive either ITMB (n=41) or ISB (n=41) with 25 mL 0.375% ropivacaine for each nerve block. Two participants in the ITMB group were excluded from the per-protocol (PP) analysis due to intraoperative conversion to open surgery and unplanned intensive care unit admission, leaving 39 ITMB patients and 41 ISB patients for primary PP analysis; intention-to-treat (ITT) analysis covering all 82 randomized patients was additionally conducted to validate robustness. The primary prespecified outcome was 24-hour postoperative total oxycodone consumption, with a predefined non-inferiority margin of -5 mg (ISB minus ITMB). Non-inferiority was established if the lower limit of the 95% confidence interval (CI) for the between-group mean difference was no less than -5 mg. Secondary endpoints comprised the maximum 11-point resting NRS pain score within 24 h, incidence of rebound pain, and rescue analgesia requirements. Safety endpoints included dyspnea, diaphragmatic paralysis, Horner’s syndrome, and postoperative nausea and vomiting.
RESULTS: PP analysis showed the mean 24-hour oxycodone consumption was 11.26 (SD 4.38) mg in the ISB group (95% CI 9.89 to 12.65) versus 10.92 (SD 3.48) mg in the ITMB group (95% CI 9.79 to 12.05), with a between-group mean difference of 0.34 mg (95% CI -1.42 to 2.11, P<0.001). The lower bound of the 95% CI (-1.42 mg) substantially exceeded the pre-specified non-inferiority margin of -5 mg, satisfying the non-inferiority criterion (one-sided non-inferiority P<0.001). ITT analysis yielded consistent non-inferiority results (mean difference 0.26 mg, 95% CI -1.46 to 1.99, P<0.001). For secondary pain outcomes, the median worst resting NRS score within 24 h was significantly lower in the ITMB group [3.0 (IQR 3.0-4.0)] than the ISB group [4.0 (IQR 3.0-7.0), median difference 1.0, 95% CI 0 to 1.0, P<0.001]. ITMB also brought significantly lower rebound pain rate (2.6% vs 26.8%, P=0.006) and less frequent rescue analgesia requirements (7.7% vs 29.3%, P=0.016). Safety outcomes revealed significantly lower early hemidiaphragmatic paralysis and dyspnea in the ITMB group: hemidiaphragmatic paralysis occurred in only 2.6% of ITMB patients vs 90.2% of ISB patients (P<0.001); dyspnea incidence was 2.6% (ITMB) vs 19.5% (ISB, P=0.016); Horner’s syndrome was absent in the ITMB group while occurring in 29% of ISB patients (P<0.001). Postoperative nausea and vomiting rates were comparable between two groups (P=0.655). No severe block-related complications such as nerve injury, local anesthetic systemic toxicity or pneumothorax were observed in either group.
CONCLUSION: Ultrasound-guided ITMB provided non-inferior 24-hour postoperative opioid analgesia compared with ISB and reduced the incidence of early hemidiaphragmatic paralysis in patients undergoing arthroscopic shoulder surgery. The comparable total 24-hour oxycodone consumption reflected distinct time-dependent analgesic profiles, with ISB providing greater analgesic benefit during the early postoperative period, whereas ITMB demonstrated more sustained analgesic effects during the later postoperative period.
TRIAL REGISTRATION: This trial was registered at the Chinese Clinical Trial Registry (ChiCTR2400084716). Date of registration: May 23, 2024.
10. Efficacy and safety of thalidomide (1 vs 2 mg/kg/d) in transfusion-dependent thalassemia: A Non-Inferiority Trial.
主题：临床试验方法与统计实践
相关性分数：4
期刊：Blood advances
公开日期：2026-09-01（电子公开）
期刊卷期日期：2026-Sep-01
内容状态：待评估
为什么值得看：包含可供初筛的摘要；已识别电子公开日期；通过方法学信号门槛；仍需阅读全文评价适用性与证据质量。
Thalidomide has emerged as a fetal hemoglobin-inducer with potential to reduce transfusion burden in transfusion-dependent thalassemia (TDT). However, optimal dosing remains undefined A prospective, randomized, open-label, multicentric clinical trial was conducted at four centres in India to compare efficacy and safety of thalidomide at 1 mg/kg/day (Group 1) versus 2 mg/kg/day (Group 2) in patients with TDT aged ≥12 years. The primary endpoint was reduction in transfusion requirement at week 24, categorized as good (>50%), moderate (25-50%), or no (<25%) response. Responders underwent stepwise dose tapering during weeks 25-72 to evaluate response sustainability. Safety assessments were performed every 4 weeks. Of 188 enrolled patients (94 per group), 82.4% completed the week-24 evaluation. The overall response rate (ORR) was 58.5%, significantly higher in Group 1 than Group 2 (67.1% vs 50.0%, p=0.012). Good, moderate, and no response were observed in 20.5%, 37.8%, and 41.6% of patients, respectively, with transfusion independence in 9 patients (5.6%). Clinical benefit was observed within 12 weeks in 71.8% of good responders and 100% moderate responders. Sustained response at week 72 was seen in 49% and 57.5% of initial responders in Groups 1 and 2, respectively. Adverse effects were mostly grade 1; drug discontinuation due to toxicity was required in 10.6 % participants. These findings suggest that Thalidomide at 1 mg/kg/day was non-inferior to 2 mg/kg/day in reducing transfusion burden in patients with TDT, with an acceptable safety profile. Low-dose thalidomide appears to be a feasible treatment option in resource-limited settings. ICMR trial registry (Trial no. CTRI/2022/05/042781).
11. [Evaluation of the efficacy and safety of multi-wavelength semiconductor laser for oral soft tissue incision and gingivectomy: a prospective, multicenter, randomized, parallel-controlled, non-inferiority clinical trial].
主题：临床试验方法与统计实践
相关性分数：4
期刊：Zhonghua kou qiang yi xue za zhi = Zhonghua kouqiang yixue zazhi = Chinese journal of stomatology
公开日期：2026-09-01（电子公开）
期刊卷期日期：2026-Sep-01
内容状态：待评估
为什么值得看：包含可供初筛的摘要；已识别电子公开日期；通过方法学信号门槛；仍需阅读全文评价适用性与证据质量。
Objective: To evaluate the clinical efficacy and safety of the multi-wavelength semiconductor laser therapeutic instrument in oral soft tissue incision and gingivectomy. Methods: A total of 156 patients who received mandibular impacted wisdom tooth extraction combined with oral soft tissue incision or gingivectomy at the Stomatological Hospital of Zhejiang University School of Medicine, Zhejiang Hospital and Wenzhou Central Hospital between June 2023 and March 2024 were enrolled and divided into experimental group (n=78) and control group (n=78) by stratified block randomization method. During the operation, the experimental group used the multi-wavelength semiconductor laser therapeutic instrument to complete soft tissue incision and gingivectomy in the surgical area, while the control group used the single-wavelength semiconductor laser therapeutic instrument for the corresponding procedures. Follow-up assessments were conducted one week and one month postoperatively for both groups of patients. Primary outcomes were the excellent and good rate of intraoperative hemostasis and wound healing at one week postoperatively, which were analyzed by non-inferiority test. Secondary outcomes included laser cutting efficiency, convenience of disinfection, operational convenience, operational safety and stability, which were assessed using the Wilcoxon rank-sum test, χ2 test or Fisher’s exact probability method. Safety indicator was the incidence of adverse events, which was analyzed using Fisher’s exact probability method. Results: Primary efficacy evaluation: the excellent and good rate of intraoperative hemostasis [100.0% (78/78) vs. 100.0% (78/78)] and wound healing [100.0% (78/78) vs 98.7% (77/78)] in the experimental group were both non-inferior to those in the control group. Secondary efficacy evaluation: the laser cutting efficiency in experimental group [(0.08±0.07) mm/s] was significantly higher than that in control group [(0.06±0.04) mm/s] (Z=-2.87, P=0.004). There were no significant differences in disinfection convenience, operational convenience, safety, and stability between the two groups (all P>0.05). Regarding safety evaluation, no adverse events occurred in the experimental group, while 2 cases (2.6%) of mild or moderate adverse events and 1 case (1.3%) of serious adverse events occurred in the control group, with no significant difference (P>0.05). Conclusions: The efficacy and safety of the multi-wavelength semiconductor laser therapeutic instrument are non-inferior to the control products, meeting the standards for clinical validation.
目的： 评价多波长半导体激光治疗仪用于口腔软组织切开、牙龈切除术的临床有效性和安全性。 方法： 纳入2023年6月至2024年3月在浙江大学医学院附属口腔医院、浙江医院、温州市中心医院就诊，需拔除下颌阻生智齿且需进行口腔软组织切开、牙龈切除的156例患者，采用分层区组随机法将患者分为试验组（78例）和对照组（78例），术中试验组使用多波长半导体激光治疗仪完成术区软组织切开及牙龈切除操作，对照组使用单波长半导体激光治疗仪完成术区软组织切开及牙龈切除操作。对两组患者术后1周、1个月进行随访。主要有效性评价指标为术中止血效果优良率、术后1周伤口愈合情况优良率，采用非劣效检验；次要有效性评价指标为激光切割效率、设备的消毒便利性、操作便利性、操作安全性及稳定性，采用Wilcoxon秩和检验、χ2检验或Fisher精确概率法检验；安全性指标为不良事件发生率，采用Fisher精确概率法检验。 结果： 主要有效性评价：试验组术中激光止血效果优良率为100.0%（78/78），术后1周伤口愈合情况优良率为100.0%（78/78），均非劣于对照组的100.0%（78/78）、98.7%（77/78）。次要有效性评价：试验组激光切割效率［（0.08±0.07）mm/s］显著高于对照组［（0.06±0.04）mm/s］（Z=-2.87，P=0.004），消毒便利性、操作便利性、安全性及稳定性评价与对照组相比差异均无统计学意义（均P>0.05）。安全性评价方面，试验组无不良事件发生，对照组发生3例不良事件，2例（2.6%）为轻、中度不良事件，1例（1.3%）为严重不良事件，两组不良事件发生率差异无统计学意义（P>0.05）。 结论： 多波长半导体激光治疗仪用于下颌阻生智齿拔除患者口腔软组织切开、牙龈切除术的有效性和安全性良好，与对照组相当。.
12. Efficacy and safety of semaglutide injection in Indian patients with type 2 diabetes mellitus inadequately controlled on metformin: A phase 3, randomized, active-controlled, multicenter, non-inferiority trial (WIN-IND study).
主题：临床试验方法与统计实践
相关性分数：4
期刊：Metabolism open
公开日期：2026-08-05（电子公开）
期刊卷期日期：2026-Sep
内容状态：待评估
为什么值得看：包含可供初筛的摘要；已识别电子公开日期；通过方法学信号门槛；仍需阅读全文评价适用性与证据质量。
BACKGROUND: Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder with a rapidly rising global burden. Present study established the non-inferiority and evaluated the safety of Intas semaglutide (test) compared to Innovator semaglutide (reference) in patients with T2DM inadequately controlled on metformin.
METHODS: This prospective, randomized, open-label, multicenter phase 3 trial, conducted between July-2025 and February-2026, enrolled adult patients (18-65 years) with T2DM and HbA1c level ≥7%-<10.5% at baseline, who had been on diet, exercise and metformin (≥1500 mg/day). Randomized (1:1) patients received either test or reference product, once weekly from 1 to 24 weeks. Primary endpoint was the change in HbA1c level. Secondary endpoints were the change in fasting blood glucose (FBG) level, post-prandial blood glucose (PPBG) level, bodyweight, body mass index (BMI), and lipid parameters. Safety assessment included monitoring of treatment emerged adverse events (TEAEs).
RESULTS: Study analyzed 223 (safety set) and 217 (ITT set) patients. Baseline characteristics were comparable between treatment groups. In the ITT (LOCF) set, at week-24, LSM change in HbA1c was -1.50 vs. -1.65 in test vs. reference group, respectively; LSM difference was 0.16 (95% CI: -0.16 to 0.47, P = 0.3266), confirming non-inferiority of the test product. Other efficacy parameters (FBG and PPBG levels, bodyweight and BMI) were also similarly reduced in the test group. The incidence, severity, and pattern of TEAEs were similar, without new safety signals identified.
CONCLUSION: Intas semaglutide showed non-inferiority to reference semaglutide with comparable efficacy, immunogenicity, and safety which may provide a cost-effective alternative treatment option to Indian patients with T2DM.
CLINICAL TRIAL REGISTRATION NUMBER: CTRI/2025/06/089290.
13. Transitions in depressive symptom states among adults with subthreshold depression: Associations with lifetime trauma exposure and combined lifestyle in a multistate Markov study.
主题：生存与复杂事件结局方法
相关性分数：4
期刊：Journal of affective disorders
公开日期：2026-08-04（电子公开）
期刊卷期日期：2026-Dec-01
内容状态：待评估
为什么值得看：包含可供初筛的摘要；已识别电子公开日期；通过方法学信号门槛；仍需阅读全文评价适用性与证据质量。
BACKGROUND: Subthreshold depression is common, but whether lifetime trauma exposure and combined lifestyle are differentially associated with symptom transitions remains unclear.
METHODS: We analyzed a prospective community cohort in Shenzhen, China, of adults aged 18-65 years with a Patient Health Questionnaire-9 (PHQ-9) score ≥ 5 and no depressive disorder at baseline. Depressive symptom states (Normal, Mild, and Moderate/Severe) were assessed repeatedly over 36 months. Continuous-time multi-state Markov models estimated transition intensities, probabilities, and hazard ratios (HRs) for lifetime trauma exposure and a five-component combined lifestyle score, adjusting for demographic, socioeconomic, and health-related covariates.
RESULTS: Among 2361 participants (mean age, 37.30 years; 61.9% women), recovery transitions were more frequent than worsening transitions. The monthly Mild-to-Normal intensity was 0.131 (95% CI, 0.100-0.171), 2.47 times the Mild-to-Moderate/Severe intensity; Moderate/Severe-to-Mild was highest (0.205; 95% CI, 0.158-0.272). Lifetime trauma exposure was associated with lower Mild-to-Normal (HR, 0.54; 95% CI, 0.42-0.69) and Moderate/Severe-to-Mild rates (HR, 0.52; 95% CI, 0.41-0.65). Unfavorable lifestyle was associated with a lower Mild-to-Normal rate (HR, 0.70; 95% CI, 0.53-0.92) and a higher Mild-to-Moderate/Severe rate (HR, 1.60; 95% CI, 1.13-2.25). Those with both exposures had the lowest Mild-to-Normal rate (HR, 0.39; 95% CI, 0.26-0.59) and a higher Mild-to-Moderate/Severe rate (HR, 1.69; 95% CI, 1.05-2.73).
CONCLUSIONS: Lifetime trauma exposure was associated with lower recovery rates, whereas an unfavorable lifestyle was associated with lower recovery and higher worsening rates. These associations may inform trauma-informed assessment and lifestyle support for adults with subthreshold depression.
14. Benefit of Linked-Color Imaging in Artificial Intelligence-Assisted Diagnosis of Early Gastric Cancer: A Pilot Study With Propensity Score Adjustment.
主题：因果推断、RWE 与卫生经济学
相关性分数：4
期刊：DEN open
公开日期：2026-07-28（电子公开）
期刊卷期日期：2027-Apr
内容状态：待评估
为什么值得看：包含可供初筛的摘要；已识别电子公开日期；通过方法学信号门槛；仍需阅读全文评价适用性与证据质量。
BACKGROUND AND AIMS: Artificial intelligence (AI)-assisted endoscopy represents a promising approach for lesion detection, yet frequent false-positive detections impair clinical utility by disrupting examinations and diminishing physician confidence. Linked-color imaging (LCI), an image-enhanced endoscopy technique that amplifies mucosal and vascular contrast, may address this limitation. This investigation evaluated whether LCI reduces false-positive AI detections compared with white-light imaging (WLI).
METHODS: This retrospective study analyzed consecutive AI-assisted upper endoscopies performed between March 2024 and June 2025. WLI and LCI were performed sequentially within the same endoscopic session in each patient. False-positive AI detections were compared between modalities using two computer-aided detection (CAD) versions. Propensity score adjustment was used as a sensitivity analysis for baseline differences between CAD Versions I and II.
RESULTS: Of 66 initially screened cases, 63 remained after excluding patients with prior gastric surgery. LCI reduced false-positive AI detections compared with WLI (median 2 vs. 5; p < 0.001). In CAD version-stratified sensitivity analyses, LCI reduced false-positive AI detections in both Version I (5 to 2; p = 0.01) and Version II (2 to 0; p = 0.03). This reduction remained consistent across atrophic grades. Both imaging modalities identified all gastric lesions, achieving 100% detection sensitivity.
CONCLUSIONS: LCI assessment performed after WLI observation yielded fewer false-positive CAD-EYE detections while maintaining lesion detection sensitivity. However, because the observation sequence was fixed, these findings should be interpreted cautiously and require confirmation in prospective or counterbalanced studies.
UNLABELLED: Trial Registration: N/A (retrospective study).
15. Transcutaneous auricular vagus nerve stimulation combined with ciprofol for sedation in patients undergoing same-session bidirectional endoscopy: a randomized, double-blind, placebo-controlled, three-arm non-inferiority trial protocol.
主题：临床试验方法与统计实践
相关性分数：4
期刊：Annals of medicine
公开日期：2026-07-01（电子公开）
期刊卷期日期：2026-Dec
内容状态：待评估
为什么值得看：包含可供初筛的摘要；已识别电子公开日期；通过方法学信号门槛；仍需阅读全文评价适用性与证据质量。
BACKGROUND: Transcutaneous auricular vagus nerve stimulation (taVNS) provides targeted modulation of the autonomic nervous system and descending pain pathways, exerting analgesic potential. However, high-quality evidence remains insufficient to determine whether taVNS can effectively replace opioids in sedation regimens for same-session bidirectional endoscopy while maintaining the quality of early postoperative recovery.
DISCUSSION: This study is a single-center, prospective, randomized, double-blind, placebo-controlled, three-arm non-inferiority trial. A total of 181 patients scheduled for painless same-session bidirectional endoscopy will be enrolled and randomly assigned using dynamic block randomization to one of three groups: Group S (sufentanil 0.1 µg/kg plus sham taVNS), Group T (normal saline plus active taVNS), and Group P (normal saline plus sham taVNS). All participants will receive ciprofol for sedation induction and maintenance. The primary outcome will be the quality of recovery at 24 h postoperatively, assessed using the 15-item Quality of Recovery scale (QoR-15), with a predefined non-inferiority margin (δ) of 6 points, which corresponds to the minimal clinically important difference of the QoR-15 scale. Secondary outcomes will include perioperative adverse events (pre-, intra-, and postoperative, including taVNS-related events), QoR-15 score at 1 h postoperatively, procedural and recovery efficiency indices, sedative dosage, and patient and endoscopist satisfaction scores. Blinding effectiveness will be assessed in all participants, and statistical analyses will follow the modified intention-to-treat principle.
CONCLUSION: This study protocol will rigorously assess the effectiveness and safety of taVNS as an alternative to opioid analgesics for sedation during same-session bidirectional endoscopy using, to our knowledge, the first three-arm design.Trial registration: Chinese Clinical Trial Registry (ChiCTR2600117962).
This study will provide the first systematic evaluation of the feasibility and efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) as an opioid-sparing alternative to sufentanil for ciprofol-based sedation during same-session bidirectional endoscopy.A three-arm randomized design incorporating a prespecified trial-sensitivity analysis will be used to rigorously validate the effectiveness of the standard regimen, enhancing the interpretability and credibility of the non-inferiority conclusion.An “active placebo” taVNS stimulation model combined with an improved standardized questionnaire for blinding assessment will be employed to address the well-recognized limitations of inadequate blinding in taVNS research.
16. Efficacy and Safety of an Insulin Patch Pump Compared to Multiple Daily Injections in Pediatric Patients With Diabetes: A Randomized, Open-Label, Crossover, Non-Inferiority Clinical Trial.
主题：临床试验方法与统计实践
相关性分数：3
期刊：Clinical medicine insights. Endocrinology and diabetes
公开日期：2026-09-07（电子公开）
期刊卷期日期：2026
内容状态：待评估
为什么值得看：包含可供初筛的摘要；已识别电子公开日期；通过方法学信号门槛；仍需阅读全文评价适用性与证据质量。
BACKGROUND: Insulin patch pumps offer advantages over multiple daily injections (MDI) for pediatric diabetes, but randomized trial evidence in Chinese children remains limited.
OBJECTIVES: To evaluate the efficacy and safety of a tubeless insulin patch pump (Equil™) compared with MDI in children and adolescents with diabetes.
METHODS: This multicenter, open-label, randomized, crossover, non-inferiority trial was conducted at seven pediatric endocrinology centers in China (September 2021 - October 2022). Patients aged 3-17 years with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) were randomized 1:1 to receive continuous subcutaneous insulin infusion (CSII) via Equil™ or MDI via insulin pen for 5 days, followed by crossover. The primary outcome was mean blood glucose (MBG). Non-inferiority margin was pre-specified as 0.386 mmol/L. Secondary outcomes included glycemic variability (standard deviation of blood glucose, SDBG), glycated albumin (GA), total daily insulin dose (TDD), hypoglycemia frequency, and adverse events. Patient satisfaction was assessed using a study-specific 11-item questionnaire.
RESULTS: Of 74 enrolled patients, 72 (97.3%) completed the study. CSII demonstrated non-inferiority to MDI for MBG (8.43±1.88 mmol/L, n=74, vs 9.00±2.04 mmol/L, n=72); mean difference -0.606 mmol/L; 95% CI -0.988 to -0.223; upper CI limit -0.223 < non-inferiority margin 0.386. No significant differences were observed for secondary outcomes (SDBG: 3.019 vs 3.357; GA change: 2.52±3.03% vs 2.02±3.25%, p=0.184; TDD: 132.17±78.43 vs 147.52±91.59 IU, p=0.159; hypoglycemia events: 114 vs 106). Adverse event rates were similar (75.7% vs 69.4%, p=0.399); no serious adverse events occurred. Patient satisfaction was significantly higher with CSII (total score 21.03±4.47 vs 22.00±3.99; mean difference -0.97, 95% CI -1.75 to -0.19; p=0.015), with 68.1% of patients preferring the patch pump.
CONCLUSION: The Equil™ patch pump is non-inferior to MDI in terms of glycemic control and safety for pediatric diabetes patients, with higher patient satisfaction. These findings support the patch pump as an effective alternative for children and adolescents requiring exogenous insulin therapy.
This study compared two ways of giving insulin to children and teenagers with diabetes: an insulin patch pump (a small device that sticks to the skin and delivers insulin continuously) and daily insulin shots (multiple daily injections, or MDI). A total of 74 children and teenagers (aged 3–17 years) from seven hospitals in China took part. Each participant used both methods for 5 days each. The study found that the patch pump worked just as well as daily shots for controlling blood sugar levels. There were no major safety concerns with either method. Patients reported higher satisfaction with the patch pump, especially regarding flexibility and daily life impact, and 68 out of every 100 participants preferred the patch pump over daily shots.
17. Post-transplant CKLM: extending integrated clinical trial design to solid organ transplant recipients.
主题：临床试验方法与统计实践
相关性分数：3
期刊：Gut
公开日期：2026-09-07（电子公开）
期刊卷期日期：2026-Sep-07
内容状态：待评估
为什么值得看：暂缺摘要，需回到 PubMed 核验；已识别电子公开日期；通过方法学信号门槛；仍需阅读全文评价适用性与证据质量。
18. OSeMOSYS-RDM: A reproducible workflow for robust decision making with OSeMOSYS models.
主题：可复现研究与开放科学
相关性分数：3
期刊：MethodsX
公开日期：2026-08-18（电子公开）
期刊卷期日期：2026-Dec
内容状态：待评估
为什么值得看：包含可供初筛的摘要；已识别电子公开日期；通过方法学信号门槛；仍需阅读全文评价适用性与证据质量。
Long-term energy planning under deep uncertainty benefits from stress-testing strategies across many plausible futures. OSeMOSYS-RDM is an open-source, reproducible workflow that couples Robust Decision Making (RDM) with the Open Source energy Modeling System (OSeMOSYS). It automates uncertainty sampling (Latin Hypercube Sampling, LHS), ensemble model execution across multiple solvers, standardized post-processing, and scenario discovery using the Patient Rule Induction Method (PRIM). The workflow is configuration-driven (Excel and YAML), supports workflow reproducibility via Data Version Control (DVC), and produces shareable inputs/outputs for transparent, repeatable studies. Although developed for energy-system models, it can be applied to any OSeMOSYS-encoded system (e.g., land use or industrial processes). This MethodsX article provides a standalone description of the architecture, configuration interface, and outputs to enable reuse and adaptation by the OSeMOSYS community. The workflow automates the quantitative core of an RDM study (experimental design, ensemble execution, and scenario discovery) and is intended to support -not replace- participatory engagement with decision makers through which a full RDM analysis is framed and deliberated.•OSeMOSYS-RDM uses Excel and YAML configuration files to define uncertainties, experiments, and outputs without modifying the core workflow code.•It automates Latin Hypercube Sampling, batch and parallel solver execution (GLPK, CBC, CPLEX, and Gurobi), standardized post-processing into shareable datasets, and DVC-based pipeline execution for reproducible runs.•The method is demonstrated on a multisectoral Uganda model and a Costa Rica transport decarbonization application.
19. Resistance to a Novel Clinical Trial Design for Multicancer Detection Tests: Experimental Investigation of Ambiguity Aversion.
主题：临床试验方法与统计实践
相关性分数：3
期刊：MDM policy & practice
公开日期：2026-09-02（电子公开）
期刊卷期日期：2026
内容状态：待评估
为什么值得看：包含可供初筛的摘要；已识别电子公开日期；通过方法学信号门槛；仍需阅读全文评价适用性与证据质量。
BACKGROUND: Randomized controlled trials (RCTs) are needed to evaluate multicancer detection (MCD) tests. A novel “intended-effect” RCT design in which control group participants receive MCD testing but results remain undisclosed can increase statistical efficiency. Prospective participants may find this design unacceptable due to ambiguity aversion introduced by the existence of undisclosed but theoretically knowable test results. We evaluated this effect and tested if reducing ambiguity by ensuring the unknowability of test results mitigates this bias.
METHODS: US adults aged 45 to 70 y (N = 1,576) were randomized to read about 1 of 4 RCT designs evaluating MCD testing: 1) RCT with a conventional control group (no testing), 2) RCT with a standard intended-effect control group (ie, control gets testing but not the results), 3) modified intended-effect RCT emphasizing disclosure safeguards to ensure the unknowability of control group test results to participants and researchers, and 4) modified intended-effect RCT with time-delayed testing on control group blood samples after trial completion. Outcomes were study interest (5-point scale, with higher values indicating more interest) and intention to participate (yes/no). Analyses of variance, chi-square tests, and regression-based analyses examined the main effects and potential mediating roles of the perceived net benefit of participating in the study and trust in study researchers.
RESULTS: Intention to participate was similar across all conditions (range: 14%-21%). Study interest was higher in the conventional control (M = 3.73) vs the 3 intended-effect designs (P < 0.05), which did not differ (Ms = 3.36-3.45). The negative influence of intended-effect designs on study interest was partially mediated by perceived net benefit.
CONCLUSION: Intended-effect RCT designs lower interest in MCD trial participation, in part by reducing prospective participants’ perceptions of benefiting from the trial. Strategies to reduce ambiguity do not mitigate this effect.
20. Cost-effectiveness analysis of Cardioform vs. Amplatzer: concerns regarding methodological transparency and interpretation of clinical results.
主题：因果推断、RWE 与卫生经济学
相关性分数：3
期刊：Journal of medical economics
公开日期：2026-09-03（电子公开）
期刊卷期日期：2026-Dec
内容状态：待评估
为什么值得看：暂缺摘要，需回到 PubMed 核验；已识别电子公开日期；通过方法学信号门槛；仍需阅读全文评价适用性与证据质量。