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Non-pharmacological perioperative interventions to prevent postoperative pulmonary complications after abdominal surgery: a protocol for systematic review and meta-analysis. 预防腹部手术后肺部并发症的非药物围手术期干预:一项系统回顾和荟萃分析方案。
IF 3.9 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-14 DOI: 10.1186/s13643-026-03070-8
Chanyan Huang, Shujun Sun, Xiaolin Lu, Nada M Mousa, Matthew Lim, William Tang, Xinran Chen, Xuanxian Xu, Haohan Xia, Siyu Geng, Mengjia Kou, Zhengkai Liang, Archana Sharma-Oates, Dan Xu, Lin Hu, Xu Zhao, Fang Gao Smith, Xia Feng

Background: Postoperative pulmonary complications (PPCs) are common following abdominal surgery, contributing significantly to perioperative morbidity and mortality, prolonged hospitalization, and increased healthcare costs. Although various non-pharmacological strategies are frequently recommended in perioperative care, their comparative clinical effectiveness remains unclear. A rigorous synthesis of the available evidence is urgently needed to inform clinical guidelines and optimize patient outcomes.

Methods: A comprehensive literature search will be conducted in Ovid MEDLINE, Embase, and Web of Science from inception to January 2025, without language restrictions. We will include randomized controlled trials (RCTs) that evaluate structured single non-pharmacological perioperative interventions in adult patients undergoing elective abdominal surgery under general anesthesia. Only studies that clearly define PPCs will be included. The primary outcome is the proportion of patients developing composite PPCs. Secondary outcomes include each PPC subtype based on European Perioperative Clinical Outcome (EPCO) criteria (e.g., respiratory infection, respiratory failure, pleural effusion, atelectasis, or pneumothorax), hospital length of stay, and all-cause mortality. Two reviewers will independently screen studies, extract data, and assess risk of bias using the Cochrane RoB 2.0 tool. Pairwise random-effects meta-analyses using the Restricted Maximum Likelihood (REML) estimator will be performed, supplemented by trial sequential analysis to assess evidence robustness. Between-study heterogeneity will be quantified using I2. Publication bias will be evaluated through funnel plots and Egger's test. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach will be applied to assess the quality of the published literature.

Discussion: This systematic review and meta-analysis aims to provide an updated and focused synthesis of non-pharmacological interventions for preventing PPCs in adult patients undergoing abdominal surgery. By incorporating recent high-quality RCTs and applying rigorous evaluation methods, the review is expected to generate evidence directly applicable to perioperative practice, enhance clinical decision-making, support guideline development, and highlight critical areas for future research.

Systematic review registration: PROSPERO CRD42025637449.

背景:术后肺部并发症(PPCs)是腹部手术后常见的并发症,是围手术期发病率和死亡率、住院时间延长和医疗费用增加的重要因素。尽管各种非药物策略经常被推荐用于围手术期护理,但它们的比较临床效果尚不清楚。迫切需要对现有证据进行严格的综合,以便为临床指南提供信息并优化患者预后。方法:全面检索Ovid MEDLINE、Embase和Web of Science自成立至2025年1月的文献,无语言限制。我们将纳入随机对照试验(RCTs),以评估在全身麻醉下接受择期腹部手术的成年患者的结构化单一非药物围手术期干预措施。只有明确定义PPCs的研究才会被纳入。主要结局是发生复合PPCs的患者比例。次要结局包括基于欧洲围手术期临床结局(EPCO)标准的PPC亚型(如呼吸道感染、呼吸衰竭、胸腔积液、肺不张或气胸)、住院时间和全因死亡率。两名审稿人将独立筛选研究,提取数据,并使用Cochrane RoB 2.0工具评估偏倚风险。使用限制最大似然(REML)估计器进行两两随机效应荟萃分析,并辅以试验序列分析来评估证据的稳健性。研究间异质性将使用I2进行量化。发表偏倚将通过漏斗图和Egger检验进行评估。建议分级评估,发展和评价(GRADE)方法将被用于评估已发表文献的质量。讨论:本系统综述和荟萃分析旨在提供最新的、集中的非药物干预措施,以预防腹部手术成人患者发生PPCs。通过纳入近期高质量的随机对照试验,并采用严格的评估方法,该综述有望产生直接适用于围手术期实践的证据,增强临床决策,支持指南制定,并突出未来研究的关键领域。系统评价注册:PROSPERO CRD42025637449。
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引用次数: 0
Treatment effects of psychological interventions on self-harm in individuals with PTSD: A systematic review and meta-analysis protocol. 心理干预对创伤后应激障碍自我伤害的治疗效果:一项系统综述和荟萃分析方案。
IF 3.9 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-13 DOI: 10.1186/s13643-025-03065-x
Anthony Tsang, Caroline Clements, Catherine Robinson, Peter J Taylor

Background: There is robust evidence reflecting that individuals with PTSD are significantly more at risk of engaging in self-harm and suicidal behaviours. Trauma-focused interventions for PTSD, however, predominantly focus on PTSD symptomology-related outcomes. Therefore, there is a dearth of knowledge regarding the treatment effects of psychological interventions in individuals with PTSD examining self-harm-related outcomes. This evidence synthesis will identify studies that investigate interventional effects on self-harm, non-suicidal self-injury (NSSI), and suicide attempts.

Methods: A comprehensive bibliographic search will be conducted to identify eligible randomised controlled trials (RCTs) and non-RCT evaluation studies indexed in Ovid MEDLINE, Embase (Ovid), PTSDPubs (ProQuest), APA PsycInfo (Ovid), PubMed (NOT MEDLINE[SB]), Web of Science Core Collection (CPCI-SSH), CENTRAL, WHO ICTRP, and ClinicalTrials.gov from inception to present day. A range of supplementary search techniques will also be employed to reduce the file drawer effect. Two independent reviewers will screen records at a title/abstract and full-text level, with 50% extracted data being cross-checked by an independent reviewer. Eligible studies will be assessed for risk-of-bias (RoB) using Cochrane's RoB 2.0 for RCTs and ROBINS-I for non-RCTs. A combination of random- and fixed-effects meta-analytic models will be performed separately for RCTs and non-RCTs, and for post-intervention and follow-up periods for self-harm, NSSI, and suicide attempts separately and in aggregate, using d-family effect sizes (including Hedges' g) and risk ratio/odds ratio for continuous and binary outcome data, respectively, with associated 95% confidence intervals. Sensitivity analyses will be performed to examine if methodological decisions impact on summary effects. Potential sources of heterogeneity will be examined as moderators (e.g. adults versus non-adults, intervention delivery, and complex PTSD versus PTSD) using mixed-effect meta-regression models. The evaluation of certainty of evidence of all main outcomes will be conducted using the GRADE approach. The review will be reported in accordance with PRISMA-S and PRISMA 2020 guidelines.

Discussion: This systematic review and meta-analysis of RCTs and non-RCTs will provide a comprehensive synthesis of treatment effects of psychological interventions on self-harm related outcomes among individuals with PTSD. The results may increase a better understanding of which interventions are best suited to targeting self-harm outcomes in this population. The completed review will be published in a peer-reviewed journal.

Systematic review registration: PROSPERO CRD42024598594.

背景:有强有力的证据表明,患有创伤后应激障碍的个体明显更有可能从事自残和自杀行为。然而,以创伤为重点的PTSD干预主要集中在PTSD症状相关的结果上。因此,关于心理干预对PTSD患者自我伤害相关结果的治疗效果的知识缺乏。这一证据综合将确定研究干预对自残、非自杀性自伤(NSSI)和自杀企图的影响。方法:将进行全面的文献检索,以确定在Ovid MEDLINE、Embase (Ovid)、ptsdbars (ProQuest)、APA PsycInfo (Ovid)、PubMed (NOT MEDLINE[SB])、Web of Science Core Collection (CPCI-SSH)、CENTRAL、WHO ICTRP和ClinicalTrials.gov中索引的符合条件的随机对照试验(rct)和非rct评价研究。还将采用一系列补充搜索技术来减少文件抽屉效应。两名独立审稿人将在标题/摘要和全文级别筛选记录,其中50%的提取数据将由独立审稿人进行交叉检查。符合条件的研究将使用Cochrane的RoB 2.0(随机对照试验)和ROBINS-I(非随机对照试验)评估偏倚风险(RoB)。随机效应和固定效应的组合元分析模型将分别对随机对照试验和非随机对照试验,以及对自残、自伤和自杀企图的干预后和随访期分别和总体进行,分别使用d家族效应大小(包括Hedges' g)和连续和二元结果数据的风险比/优势比,并使用相关的95%置信区间。将进行敏感性分析,以检查方法决定是否对总效果有影响。潜在的异质性来源将作为调节因素(如成人与非成人,干预交付,复杂PTSD与PTSD)使用混合效应元回归模型进行检验。所有主要结果的证据确定性评估将使用GRADE方法进行。审查将按照PRISMA- s和PRISMA 2020指南进行报告。讨论:本研究对随机对照试验和非随机对照试验进行了系统回顾和荟萃分析,旨在全面综合心理干预对PTSD患者自我伤害相关结果的治疗效果。研究结果可能有助于更好地了解哪些干预措施最适合针对这一人群的自残结果。完成的综述将发表在同行评议的期刊上。系统评价注册:PROSPERO CRD42024598594。
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引用次数: 0
Correction: Screening for the prevention and early detection of cervical cancer: systematic reviews to inform an update to recommendations by the Canadian Task Force on Preventive Health Care. 更正:为预防和早期发现宫颈癌而进行的筛查:为更新加拿大预防保健工作队的建议而进行的系统审查。
IF 3.9 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-13 DOI: 10.1186/s13643-025-03061-1
Jennifer Pillay, Allison Gates, Samantha Guitard, Bernadette Zakher, Shannon Sim, Benjamin Vandermeer, Lisa Hartling
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引用次数: 0
A study protocol for a systematic review and meta-analysis on macroscopic body movements as a marker for acute stress. 一项关于宏观身体运动作为急性应激标志的系统回顾和荟萃分析的研究方案。
IF 3.9 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-12 DOI: 10.1186/s13643-025-03050-4
Miriam Kurz, Veronika Ringgold, Luca Abel, Felicitas Burkhardt, Robert Richer, Lena Schindler-Gmelch, Anne I Turner, Bjoern M Eskofier, Nicolas Rohleder

Background: Experiencing stress is a normative part of human life. Due to its major impact on health and longevity, effort has been put into understanding underlying determinants and consequences. For stress measurement, a vast number of different methods, including physiological, subjective, and behavioral assessments, can be used. Previous measurement methods have already provided valuable insights into the role of the stress systems. However, their application has some drawbacks, highlighting the need for more convenient, less expensive, less intrusive, and continuous methods. A promising alternative could be the assessment of macroscopic body movements, which we define as body movements that are actively, consciously, or unconsciously, initiated by the muscular system.

Methods: The study protocol was registered with PROSPERO, and PRISMA-P guidelines were followed. We will screen MEDLINE, PsycInfo, Web of Science, Embase, and Google Scholar for suitable studies in German or English with no restrictions towards the publication date. To do so, an a priori defined search strategy will be employed. Furthermore, we will carry out backward and forward citation searches. Inclusion criteria comprise studies examining macroscopic body movements in response to stress or related psychological constructs induced by standardized protocols. Exclusion criteria include studies on non-human populations as well as studies that do not report on a control group/condition nor pre-/post-comparisons nor traditional stress markers. The search, selection, and data extraction processes will be performed by two reviewers independently, while a third reviewer will be consulted in case of discrepancy. We will assess Risk of Bias using the revised Cochrane Risk of Bias tool or ROBINS-I, as appropriate. We will conduct random-effects meta-analyses where feasible. The quality of evidence will be evaluated using the GRADE approach. Furthermore, results will undergo critical examination towards meta-biases.

Discussion: Due to the growing number of studies assessing macroscopic movements in the context of stress, the field is becoming complex, highlighting the need for a summary of current findings. Thus, here we outline a study protocol for a systematic review and meta-analysis on macroscopic movements as a potential novel marker for stress.

Systematic review registration: PROSPERO CRD42024539659.

背景:经历压力是人类生活中正常的一部分。由于其对健康和寿命的重大影响,一直在努力了解潜在的决定因素和后果。对于压力测量,可以使用大量不同的方法,包括生理,主观和行为评估。以前的测量方法已经对应力系统的作用提供了有价值的见解。然而,它们的应用有一些缺点,突出表明需要更方便、更便宜、更少干扰和连续的方法。一个有希望的替代方案可能是评估宏观身体运动,我们将其定义为由肌肉系统主动,有意识或无意识发起的身体运动。方法:研究方案在PROSPERO注册,并遵循PRISMA-P指南。我们将筛选MEDLINE, PsycInfo, Web of Science, Embase和谷歌Scholar,以寻找合适的德语或英语研究,对发表日期没有限制。为此,将采用先验定义的搜索策略。此外,我们将进行反向和正向引文检索。纳入标准包括检查宏观身体运动对压力的反应或标准化方案引起的相关心理结构的研究。排除标准包括对非人类群体的研究,以及未报告对照组/条件、前后比较或传统压力标记的研究。检索、选择和数据提取过程将由两名审稿人独立完成,如果存在差异,将咨询第三名审稿人。我们将酌情使用修订后的Cochrane偏倚风险工具或ROBINS-I评估偏倚风险。我们将在可行的情况下进行随机效应荟萃分析。将使用GRADE方法评估证据的质量。此外,结果将经过对元偏差的严格检查。讨论:由于在应力背景下评估宏观运动的研究越来越多,该领域变得越来越复杂,突出了对当前发现进行总结的必要性。因此,在这里,我们概述了一项研究方案,对宏观运动作为潜在的新的压力标记进行系统回顾和荟萃分析。系统评价注册:PROSPERO CRD42024539659。
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引用次数: 0
Comparison of different mRNA testing technologies with HPV DNA testing for predicting ASCUS triage and post-cone excision outcomes: a systematic review and meta-analysis. 不同mRNA检测技术与HPV DNA检测预测ASCUS分诊和后锥体切除结果的比较:系统回顾和荟萃分析。
IF 3.9 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-12 DOI: 10.1186/s13643-025-02947-4
Chao Zhao, Mingzhu Li, Rui Chen, Yun Zhao, Jingran Li, Wei Zhao, Xia Li, Jing Zhang, Shaolan Yu, Lihui Wei

Background: Human Papillomavirus (HPV) E6/E7 mRNA testing has been proposed as a potential improvement over HPV DNA testing for predicting cervical lesion progression. This systematic review and meta-analysis evaluated the diagnostic performance of HPV E6/E7 mRNA testing across various clinical scenarios.

Methods: A comprehensive search was conducted in Medline, Embase, Cochrane, Web of Science, and other databases. Two clinical scenarios were analyzed: triage of atypical squamous cells of undetermined significance (ASCUS), prediction of post-conization recurrence.. Diagnostic accuracy was assessed using standardized quality appraisal tools, with results synthesized through forest plots and Summary Receiver Operating Characteristic (SROC) curves.

Results: In ASCUS triage, all mRNA methods, including PreTect, APTIMA, and QuantiVirus, achieved comparable sensitivity but significantly higher specificity than DNA testing, with PreTect showing the strongest performance. For post-conization recurrence prediction, QuantiVirus and PreTect assays provided similar sensitivity but greater specificity compared to HPV DNA testing.

Conclusion: HPV E6/E7 mRNA testing offers higher specificity while maintaining comparable sensitivity to HPV DNA testing across multiple clinical scenarios. For ASCUS triage, PreTect demonstrates superior performance with the highest specificity and should be prioritized for clinical implementation in this setting. For post-conization recurrence prediction, QuantiVirus provides optimal diagnostic accuracy and represents the preferred choice for surveillance following cervical conization.

Systematic review registration: PROSPERO: CRD42023473415.

背景:人乳头瘤病毒(HPV) E6/E7 mRNA检测被认为是预测宫颈病变进展的潜在改进。本系统综述和荟萃分析评估了HPV E6/E7 mRNA检测在不同临床情况下的诊断性能。方法:在Medline、Embase、Cochrane、Web of Science等数据库中进行综合检索。分析两种临床情况:未确定意义的非典型鳞状细胞(ASCUS)的分类,锥形后复发的预测。采用标准化质量评价工具评估诊断准确性,并通过森林图和综合受试者工作特征(SROC)曲线综合结果。结果:在ASCUS分诊中,所有mRNA检测方法(包括preect、APTIMA和QuantiVirus)的灵敏度均与DNA检测方法相当,但特异性明显高于DNA检测方法,其中preect表现出最强的性能。对于锥化后复发预测,QuantiVirus和preect检测与HPV DNA检测相比具有相似的敏感性,但特异性更高。结论:HPV E6/E7 mRNA检测具有更高的特异性,同时在多种临床情况下与HPV DNA检测保持相当的敏感性。对于ASCUS分诊,preect表现出最高特异性的优越性能,在这种情况下应优先用于临床应用。对于锥形手术后的复发预测,QuantiVirus提供了最佳的诊断准确性,是宫颈锥形手术后监测的首选。系统评价注册:PROSPERO: CRD42023473415。
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引用次数: 0
Assessing performance, calibration, and explainability of machine learning versus traditional models for early outcome prediction after spontaneous intracerebral hemorrhage: a systematic review and meta-analysis protocol. 评估自发性脑出血后早期预后预测的机器学习与传统模型的性能、校准和可解释性:一项系统回顾和荟萃分析方案。
IF 3.9 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-10 DOI: 10.1186/s13643-025-03059-9
Fan Bu, Rongzhen Xu, Xinyan Zhao, Qiaoxia He, Yandi Wen, Lile Xiong, Lan Qin, Hua Guan

Background: Early outcome prediction after spontaneous intracerebral hemorrhage (ICH) is critical for patient management and counseling. Although machine learning (ML) models are increasingly applied, their comparative performance and explainability relative to traditional statistical models remain unclear.

Objectives: To systematically compare the predictive performance, calibration, and explainability of ML versus traditional models for early outcomes after ICH.

Methods: Following PRISMA-P guidelines and registered in PROSPERO (CRD420251166996), this systematic review and meta-analysis will include studies developing, validating, or comparing ML and traditional models for predicting early mortality or poor functional outcome (mRS ≥ 3 or GOS ≤ 3) after ICH. Data sources will include PubMed, Embase, Scopus, Web of Science, Cochrane CENTRAL, IEEE Xplore, and major Chinese databases (CNKI, Wanfang, VIP, CBM). Two reviewers will independently screen studies, extract data, and assess risk of bias using the PROBAST + AI tool, which extends and replaces the original PROBAST framework for prediction models incorporating machine learning. Pooled analyses will employ random-effects models; confidence in the body of evidence will be summarized using an adapted approach informed by GRADE principles for prognosis evidence.

Expected results: This review will explore whether ML-based models demonstrate differences in discrimination, calibration, and explainability compared with traditional models.

Conclusions: This review will provide a comprehensive, evidence-based assessment of prognostic modeling for ICH, guiding future model design, validation, and clinical application.

Systematic review registration: PROSPERO CRD420251166996.

背景:自发性脑出血(ICH)后的早期预后预测对患者管理和咨询至关重要。尽管机器学习(ML)模型的应用越来越多,但它们与传统统计模型的比较性能和可解释性仍然不清楚。目的:系统地比较ML与传统模型对脑出血早期结果的预测性能、校准和可解释性。方法:遵循PRISMA-P指南并在PROSPERO注册(CRD420251166996),本系统综述和荟萃分析将包括开发、验证或比较ML和传统模型预测ICH后早期死亡率或功能不良结局(mRS≥3或GOS≤3)的研究。数据来源包括PubMed、Embase、Scopus、Web of Science、Cochrane CENTRAL、IEEE explore和主要中文数据库(CNKI、万方、VIP、CBM)。两名审稿人将独立筛选研究,提取数据,并使用PROBAST + AI工具评估偏差风险,该工具扩展并取代了用于结合机器学习的预测模型的原始PROBAST框架。合并分析将采用随机效应模型;对证据体的信心将根据预后证据的GRADE原则采用一种适应的方法进行总结。预期结果:本综述将探讨基于ml的模型与传统模型相比是否在区分、校准和可解释性方面存在差异。结论:本综述将为脑出血预后建模提供全面的、基于证据的评估,指导未来的模型设计、验证和临床应用。系统评价注册:PROSPERO CRD420251166996。
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引用次数: 0
The comparative efficacy and safety of sweet solutions to reduce preterm infants' pain levels: a systematic review and network meta-analysis. 甜溶液减少早产儿疼痛水平的比较疗效和安全性:系统回顾和网络荟萃分析。
IF 3.9 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-10 DOI: 10.1186/s13643-025-03043-3
Defi Efendi, Yi-No Kang, Regina Natalia, Ariesta Milanti, Putri M T Marsubrin, Christina Yeni Kustanti, Kee-Hsin Chen

Background: Sweet solutions are widely used to reduce procedural pain in preterm infants, but their comparative efficacy and safety remain unclear.

Methods: We searched CINAHL, MEDLINE, Embase, CENTRAL, Scopus, and ProQuest for randomized controlled trials comparing glucose, sucrose, or expressed breast milk with control or with each other in preterm infants. We performed a random-effects frequentist network meta-analysis across three pain time points (reactivity, regulation, recovery). Pain level served as the primary outcome, while heart rate, oxygen saturation, respiratory rate, crying time, and adverse events were designated as secondary outcomes. Treatment efficacy was subsequently ranked using P-scores and a beading plot.

Results: We screened 10,043 records, included 42 RCTs (2733 infants), and analyzed 38 RCTs (2367 infants) in the network meta-analysis. Compared to the controls alone, glucose (standardized mean difference [SMD], -0.72; 95% confidence interval [CI], -1.19 to -0.25) and sucrose (SMD, -0.56; 95% CI, -1.04 to -0.07) were associated with lower pain responses in the reaction phase. In the regulation and recovery phases, pain reduction was consistently linked to glucose, sucrose, and expressed breast milk. Those interventions were supported by results of P-scores that ranged from 0.877 to 0.917 showing glucose's superiority in the three phases. Glucose was associated with a higher risk of adverse events. Half of the 38 trials in the network meta-analysis had a low risk of bias. The evidence certainty for the primary outcome was moderate to very low, while the certainty for the secondary outcomes spanned a range from high to very low.

Conclusions: Glucose ranked most effective for reducing procedural pain in preterm infants, followed by sucrose and expressed breast milk. Future trials should evaluate optimal dosing, repeated administration, and combinations with other non-pharmacological pain-management strategies to maximize efficacy and safety.

Systematic review registration: PROSPERO CRD42023389288 Glucose is the most effective sweet solution in alleviating pain scores in preterm infants, followed by sucrose and expressed breast milk.

背景:甜溶液被广泛用于减少早产儿的程序性疼痛,但其相对疗效和安全性尚不清楚。方法:我们检索了CINAHL、MEDLINE、Embase、CENTRAL、Scopus和ProQuest,以比较早产儿中葡萄糖、蔗糖或表达母乳与对照组或彼此之间的随机对照试验。我们对三个疼痛时间点(反应性、调节、恢复)进行了随机效应频度网络元分析。疼痛水平作为主要结局,而心率、血氧饱和度、呼吸频率、哭泣时间和不良事件被指定为次要结局。随后使用p评分和串珠图对治疗效果进行排名。结果:我们筛选了10043条记录,包括42项rct(2733名婴儿),并在网络荟萃分析中分析了38项rct(2367名婴儿)。与单独对照相比,葡萄糖(标准化平均差[SMD], -0.72; 95%可信区间[CI], -1.19至-0.25)和蔗糖(SMD, -0.56; 95% CI, -1.04至-0.07)与反应期较低的疼痛反应相关。在调节和恢复阶段,疼痛的减轻一直与葡萄糖、蔗糖和泌乳有关。这些干预措施得到了p评分结果的支持,p评分范围为0.877至0.917,表明葡萄糖在三个阶段中具有优势。葡萄糖与较高的不良事件风险相关。网络荟萃分析的38个试验中有一半具有低偏倚风险。主要结果的证据确定性从中等到极低,而次要结果的证据确定性从高到极低。结论:葡萄糖是减轻早产儿手术疼痛最有效的药物,其次是蔗糖和母乳。未来的试验应评估最佳剂量,重复给药,以及与其他非药物疼痛管理策略的组合,以最大限度地提高疗效和安全性。葡萄糖是缓解早产儿疼痛评分最有效的甜味解决方案,其次是蔗糖和母乳。
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引用次数: 0
Systematic review protocol: evaluation of candidate platforms and vaccines for emerging and re-emerging viral threats. 系统审查方案:评估新出现和再出现病毒威胁的候选平台和疫苗。
IF 3.9 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-10 DOI: 10.1186/s13643-025-03051-3
Amit Bansal, Ida Sofie Karlsen Sletten, Tung Thanh Le, Stig Tollefsen, John P Shannon, Rebecca Jane Cox, Rishi Delan Pathirana

Background: Emerging viral threats such as coronavirus, influenza, Lassa fever, Mpox, and Nipah virus continue to pose significant global health challenges. The development and deployment of effective vaccines are essential for outbreak control and pandemic preparedness. This protocol describes a systematic review that will synthesize evidence on vaccine candidates targeting high-priority viral threats and major vaccine platforms.

Methods: We will include randomised controlled trials (RCTs) assessing vaccine candidates for specified viruses (coronavirus, Lassa fever, Nipah virus, and Mpox) and platforms (protein-based, viral vector, and RNA) in the human populations. To encompass the full vaccine development landscape, exploratory and preclinical studies may also be included (any type of original research). Data sources will include MEDLINE Ovid, Embase Ovid (including ClinicalTrials.gov), and Cochrane Library (including CENTRAL), and grey literature (including conference proceedings, dissertations, trial registries, and company websites). Risk of bias will be assessed using Cochrane revised tool for assessing risk of bias in randomised trials (RoB-2) and Systematic Review Centre for Laboratory Animal Experimentation (SYRCLE), and certainty of evidence will be evaluated using Grading of Recommendations Assessment, Development and Evaluation (GRADE). The primary outcomes are safety, immunogenicity, and vaccine efficacy or effectiveness, prioritised for their critical role in outbreak management and in guiding regulatory approval, public health policy, and clinical decision-making. Meta-analyses will be conducted where appropriate, using both fixed- and random-effects models. Subgroup analyses will be performed to explore heterogeneity based on virus type, vaccine platform, and outcome measures, where appropriate.

Discussion: This review will provide a comprehensive synthesis of vaccine development efforts across multiple platforms and pathogens with epidemic or pandemic potential. It will inform future research, policy, and investment decisions in global health preparedness.

Systematic review registration: PROSPERO 2025 CRD420251082338 on 6 October 2025.

背景:新出现的病毒威胁,如冠状病毒、流感、拉沙热、麻疹和尼帕病毒,继续构成重大的全球卫生挑战。开发和部署有效疫苗对于控制疫情和防备大流行至关重要。本方案描述了一项系统评价,将综合针对高优先级病毒威胁和主要疫苗平台的候选疫苗的证据。方法:我们将纳入随机对照试验(rct),评估特定病毒(冠状病毒、拉沙热、尼帕病毒和Mpox)和平台(基于蛋白质、病毒载体和RNA)在人群中的候选疫苗。为了涵盖完整的疫苗开发前景,还可以包括探索性和临床前研究(任何类型的原始研究)。数据来源将包括MEDLINE Ovid、Embase Ovid(包括ClinicalTrials.gov)和Cochrane图书馆(包括CENTRAL),以及灰色文献(包括会议记录、论文、试验登记和公司网站)。将使用Cochrane修订的随机试验偏倚风险评估工具(rob2)和实验动物实验系统评价中心(sycle)来评估偏倚风险,并使用推荐评估、发展和评价分级(GRADE)来评估证据的确定性。主要结局是安全性、免疫原性和疫苗效力或有效性,优先考虑它们在疫情管理和指导监管审批、公共卫生政策和临床决策方面的关键作用。将在适当的地方进行荟萃分析,使用固定效应和随机效应模型。在适当的情况下,将进行亚组分析,以探索基于病毒类型、疫苗平台和结果测量的异质性。讨论:本综述将提供跨多个平台和具有流行或大流行潜力的病原体的疫苗开发工作的全面综合。它将为未来全球卫生防范方面的研究、政策和投资决策提供信息。系统评价注册:PROSPERO 2025 CRD420251082338,于2025年10月6日注册。
{"title":"Systematic review protocol: evaluation of candidate platforms and vaccines for emerging and re-emerging viral threats.","authors":"Amit Bansal, Ida Sofie Karlsen Sletten, Tung Thanh Le, Stig Tollefsen, John P Shannon, Rebecca Jane Cox, Rishi Delan Pathirana","doi":"10.1186/s13643-025-03051-3","DOIUrl":"10.1186/s13643-025-03051-3","url":null,"abstract":"<p><strong>Background: </strong>Emerging viral threats such as coronavirus, influenza, Lassa fever, Mpox, and Nipah virus continue to pose significant global health challenges. The development and deployment of effective vaccines are essential for outbreak control and pandemic preparedness. This protocol describes a systematic review that will synthesize evidence on vaccine candidates targeting high-priority viral threats and major vaccine platforms.</p><p><strong>Methods: </strong>We will include randomised controlled trials (RCTs) assessing vaccine candidates for specified viruses (coronavirus, Lassa fever, Nipah virus, and Mpox) and platforms (protein-based, viral vector, and RNA) in the human populations. To encompass the full vaccine development landscape, exploratory and preclinical studies may also be included (any type of original research). Data sources will include MEDLINE Ovid, Embase Ovid (including ClinicalTrials.gov), and Cochrane Library (including CENTRAL), and grey literature (including conference proceedings, dissertations, trial registries, and company websites). Risk of bias will be assessed using Cochrane revised tool for assessing risk of bias in randomised trials (RoB-2) and Systematic Review Centre for Laboratory Animal Experimentation (SYRCLE), and certainty of evidence will be evaluated using Grading of Recommendations Assessment, Development and Evaluation (GRADE). The primary outcomes are safety, immunogenicity, and vaccine efficacy or effectiveness, prioritised for their critical role in outbreak management and in guiding regulatory approval, public health policy, and clinical decision-making. Meta-analyses will be conducted where appropriate, using both fixed- and random-effects models. Subgroup analyses will be performed to explore heterogeneity based on virus type, vaccine platform, and outcome measures, where appropriate.</p><p><strong>Discussion: </strong>This review will provide a comprehensive synthesis of vaccine development efforts across multiple platforms and pathogens with epidemic or pandemic potential. It will inform future research, policy, and investment decisions in global health preparedness.</p><p><strong>Systematic review registration: </strong>PROSPERO 2025 CRD420251082338 on 6 October 2025.</p>","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":" ","pages":"49"},"PeriodicalIF":3.9,"publicationDate":"2026-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12882252/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145949293","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy of dual HER2 blockade in neoadjuvant HER2-positive breast cancer: a meta-analysis of RCTs. 双重HER2阻断治疗新辅助HER2阳性乳腺癌的疗效:一项随机对照试验的荟萃分析
IF 3.9 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-09 DOI: 10.1186/s13643-025-03058-w
Wu Chen, Ling Yang, Ji Zhang, Ye Yuan

Introduction: HER2-positive breast cancer is an aggressive subtype that benefits from targeted therapies. According to the Chinese Society of Clinical Oncology (CSCO) guidelines and the National Comprehensive Cancer Network (NCCN), the combination of trastuzumab (H) with pertuzumab (P) and neoadjuvant chemotherapy has become the standard treatment for patients with HER2-positive breast cancer in the neoadjuvant setting. Nevertheless, the long-term survival benefits of neoadjuvant dual HER2 blockade (P + H) remain unaddressed by comprehensive meta-analyses to date. This study is the first systematic review and meta-analysis to directly compare the long-term efficacy of P + H vs. H (excluding trastuzumab-derived or similar drugs, such as T-DM1, T-DXd, and so on) in the neoadjuvant treatment of HER2-positive breast cancer.

Methods: We conducted a systematic literature search in PubMed, Embase, the Cochrane Library, CNKI, Wan Fang, and VIP databases for relevant studies published up to June 1, 2025. RCTs with HER2-positive breast cancer patients who had not received breast cancer-related treatments previously were included. Treatment of P + H or H arms with chemotherapy combined with pertuzumab plus trastuzumab or trastuzumab as neoadjuvant treatment. The primary outcome was the event-free survival (EFS), disease-free survival (DFS), and overall survival (OS), and secondary outcomes included total pathological complete response (tpCR), objective response rate (ORR), and grade ≥ 3 adverse effects (AEs). The quality of evidence was assessed using the GRADE.

Results: A total of six RCTs involving 803 patients were included. In long-term efficacy, the P + H arm showed significant improvements in 3-year EFS rate (RR 1.08, 95% CI 1.00-1.16, p = 0.04), 5-year EFS rate (RR 1.10, 95% CI 1.01-1.20, p = 0.03), 5-year EFS (HR 0.58, 95% CI 0.38-0.87, p = 0.009), 5-year DFS rate (RR 1.09, 95% CI 0.99-1.20), and 5-year DFS (HR 0.55, 95% CI 0.35-0.84), compared to the H arm. In short-term efficacy, the P + H arm showed significant improvements in tpCR (RR 1.76, 95% CI 1.39-2.23, p < 0.001) and ORR (RR 1.18, 95% CI 1.09-1.27, p < 0.001) compared to the H arm. The outcome of 5-year DFS rate had moderate-quality evidence, and the outcome of 3-year EFS rate, 5-year EFS rate, 5-year EFS (HR), 5-year DFS (HR), tpCR had high-quality evidence.

Conclusions: Dual HER2 blockade with pertuzumab and trastuzumab demonstrated superior short- and long-term efficacy compared with trastuzumab alone, with each treatment showing a distinct but manageable safety profile.

Systematic review registration: PROSPERO CRD42021286130.

her2阳性乳腺癌是一种侵袭性亚型,可从靶向治疗中获益。根据中国临床肿瘤学会(CSCO)指南和国家癌症综合网络(NCCN),曲妥珠单抗(H)联合帕妥珠单抗(P)联合新辅助化疗已成为her2阳性乳腺癌患者在新辅助环境下的标准治疗方案。然而,迄今为止,新辅助双重HER2阻断(P + H)的长期生存益处仍未得到全面的荟萃分析。本研究是第一个直接比较P + H与H(不包括曲妥珠单抗衍生或类似药物,如T-DM1、T-DXd等)在her2阳性乳腺癌新辅助治疗中的远期疗效的系统综述和荟萃分析。方法:系统检索PubMed、Embase、Cochrane Library、CNKI、万方、VIP等数据库,检索截至2025年6月1日发表的相关研究。纳入了先前未接受乳腺癌相关治疗的her2阳性乳腺癌患者的随机对照试验。化疗联合帕妥珠单抗+曲妥珠单抗或曲妥珠单抗作为新辅助治疗治疗P + H或H组。主要结局是无事件生存期(EFS)、无疾病生存期(DFS)和总生存期(OS),次要结局包括总病理完全缓解期(tpCR)、客观缓解率(ORR)和≥3级不良反应(ae)。采用GRADE评价证据质量。结果:共纳入6项rct,共803例患者。在长期疗效方面,与H组相比,P + H组在3年EFS率(RR 1.08, 95% CI 1.00-1.16, P = 0.04)、5年EFS率(RR 1.10, 95% CI 1.01-1.20, P = 0.03)、5年EFS (HR 0.58, 95% CI 0.38-0.87, P = 0.009)、5年DFS率(RR 1.09, 95% CI 0.99-1.20)和5年DFS (HR 0.55, 95% CI 0.35-0.84)方面均有显著改善。在短期疗效方面,P + H组在tpCR方面显示出显著改善(RR 1.76, 95% CI 1.39-2.23, P)。结论:与单曲妥珠单抗相比,帕妥珠单抗和曲妥珠单抗双HER2阻断显示出更优的短期和长期疗效,每种治疗均显示出独特但可控的安全性。系统评价注册号:PROSPERO CRD42021286130。
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引用次数: 0
Toward a unified theoretical model of bulimia nervosa: protocol for a systematic review and synthesis of existing theories. 迈向神经性贪食症的统一理论模型:现有理论的系统回顾和综合方案。
IF 3.9 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-09 DOI: 10.1186/s13643-025-03047-z
Kristine Schönhals, Vanessa Opladen, Lukasz Stasielowicz, Klaske A Glashouwer, Silja Vocks

Background: Bulimia nervosa is a severe mental disorder associated with several physical and mental health complications. The aim of this review is to provide an overview of existing theoretical models regarding the development and maintenance of bulimia nervosa. A second aim is to develop a synthesis to allow for a more complete understanding of bulimia nervosa, which may help to develop and refine interventions in the future.

Methods: PsycInfo, PubMed, PSYNDEX, Scopus, and Google Scholar will be searched for studies presenting models of bulimia nervosa. Topic modeling will be used to gain initial insights into related factors. Additionally, two independent expert reviewers will screen the literature and select models of bulimia nervosa as well as associated datasets for additional empirical analyses. In the case of discrepancies, a third reviewer will be consulted. The similarities between the identified models of bulimia nervosa will be summarized in a narrative synthesis. Depending on the number of identified models and available datasets, models will be tested using existing datasets.

Discussion: The review seeks to summarize existing models regarding the development and maintenance of BN. The results could be used as a starting point for developing adequate models, testing these models, and subsequently using them to inform evidence-based intervention programs in the future.

Systematic review registration: This systematic review was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 30.09.2024 (CRD42024581179).

背景:神经性贪食症是一种严重的精神障碍,伴有多种生理和心理健康并发症。本综述的目的是提供关于神经性贪食症发展和维持的现有理论模型的概述。第二个目标是发展一种综合方法,以便更全面地了解神经性贪食症,这可能有助于在未来开发和完善干预措施。方法:检索PsycInfo、PubMed、PSYNDEX、Scopus和谷歌Scholar等网站,检索有关神经性贪食症模型的研究。主题建模将用于获得对相关因素的初步见解。此外,两位独立的专家审稿人将筛选文献并选择神经性贪食症模型以及相关数据集进行额外的实证分析。如有差异,将咨询第三位审稿人。在确定模型之间的相似性神经性贪食症将总结在一个叙事综合。根据已识别模型和可用数据集的数量,模型将使用现有数据集进行测试。讨论:本文旨在总结现有的BN发展和维护模式。这些结果可以作为一个起点,用于开发适当的模型,测试这些模型,并随后使用它们为未来的循证干预计划提供信息。系统评价注册:本系统评价已于2024年9月30日在国际前瞻性系统评价注册(PROSPERO)注册(CRD42024581179)。
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