Systematic Reviews最新文献

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.

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.

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.

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.

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.

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).

Background: Early intervention for psychotic spectrum disorders can improve long-term outcomes, but service availability and quality can vary globally. Mobile apps have the potential to provide personalised and accessible support for people with psychotic disorders via features such as symptom monitoring, medication reminders, and self-management interventions. Existing reviews have provided an overview of such apps and their feasibility but lack a synthesis of their efficacy, safety, and acceptability. Addressing this gap would guide future app designs and facilitate their implementation by informing clinical and policy decisions. The purpose of this systematic review will be to synthesise the evidence about existing mobile apps for psychotic disorders, including their types and features, feasibility of implementation, usability, clinical impact, and safety.

Methods: This protocol has been structured using the PRISMA-P checklist, and the PICOS framework will guide the search strategy. Six electronic databases (PubMed, Embase, CINAHL, Scopus, Web of Science, and PsycInfo) will be searched. Evaluations of mobile apps for psychotic disorders published in English will be included. Reviews will be excluded but their bibliographies will be searched for relevant articles. Two independent reviewers will conduct the title and abstract screening, full-text review, data extraction into a predetermined form, and risk of bias analysis; with any disagreements discussed until consensus at each stage. The risk of bias analysis will be conducted using the Cochrane Collaboration Risk of Bias 2 and Mixed Methods Appraisal Tool. Meta-analyses will summarise data on feasibility, impact, and safety (where applicable), and app characteristics and user experience will be descriptively analysed.

Discussion: While current reviews synthesise information about apps for psychotic disorders, most of them have a narrow focus on specific app types (e.g., monitoring), outcomes (e.g., engagement), or study types. This systematic review will update previous reviews and add a comprehensive synthesis of app features, their safety, and their overall impact. This review will inform future app development and evaluations and facilitate their implementation in clinical services. It will also address the potential negative impacts associated with these apps and propose ways to mitigate them.

Systematic review registration: PROSPERO CRD42024615781.

Background: Heart rate control is one of the cornerstones of atrial fibrillation (AF) management and is recommended in all AF patients, even as background therapy for rhythm control. Both non-dihydropyridine calcium channel blockers and beta blockers are recommended as first choice rate control drugs, but no preference is given. Even though there are important differences in pharmacological mechanisms and side effects between these drugs, large randomized controlled trials are lacking. We aim to critically evaluate and synthesize the scientific evidence comparing calcium channel blockers and beta blockers.

Methods: A systematic review is conducted in four databases: MEDLINE, Embase, Web of Science, and Cochrane Central, collecting all original research published up until March 2025. Studies including patients with AF (P) treated with non-dihydropyridine calcium channel blockers (I) or beta blockers (C) reporting heart rate (O) or other key secondary outcomes such as major adverse cardiac and cerebrovascular events or mortality will be included. Titles and abstracts, as well as full texts, will be screened by two reviewers, and results will be reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. Assessment of risk of bias is evaluated using the Cochrane Risk-of-Bias (RoB 2) tool for randomized controlled trials and the Risk Of Bias In Non-Randomized Studies - of Interventions (ROBINS-I) tool for non-randomized studies. If sufficient homogeneous data are available, meta-analyses are performed.

Discussion: Current systematic reviews on rate control in AF have primarily focused on acute rate control using the intravenous administration of calcium channel blockers and beta blockers. However, systematic reviews comparing these two drug classes for long-term rate control are lacking, and current guidelines offer little guidance for choosing one drug over the other. This systematic review with meta-analysis will compare the effects of calcium channel blockers and beta blockers on heart rate and provide a comprehensive overview of clinical outcomes and side effects in the treatment of AF. It aims to provide a comprehensive overview, helping clinicians tailor rate control for individual patients.

Systematic review registration: PROSPERO CRD42024526695.

Background: Dysphagia is a common health problem that affects the quality of life of millions of people. Several studies have shown that gamified swallowing exercise has a demonstrated potential to improve training adherence and swallowing function among adults with dysphagia. However, this evidence has not been fully systematically synthesized. This systematic review and meta-analysis aims to systematically examine the effectiveness of gamified swallowing exercise in improving swallowing function among adults with dysphagia.

Methods: The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol (PRISMA-P) 2015 checklist was followed to report the protocol. We will conduct the first retrieval in PubMed, Web of Science, Embase, CINAHL, Scopus, the Cochrane Library, JBI, SinoMed, CNKI, and Wanfang on March 1, 2025. Before completing the systematic review, all target databases will be re-searched to capture the relevant publications, and the timing of the secondary retrieval will be reported in the final review. This systematic review aims to synthesize evidence from randomized controlled trials (RCTs) evaluating the effectiveness of gamified swallowing exercise in adult dysphagia populations. The primary outcomes of interest include swallowing function, while the secondary outcomes encompass adherence, nutritional status, and quality of life. Methodological quality will be rigorously assessed using the Cochrane Risk of Bias tool 2.0. Data analyses will be conducted using RevMan 5.4 software, with the random-effects model being prioritized. The protocol will incorporate three analytical approaches: (1) subgroup analysis to explore heterogeneity sources, with the Instrument for the Credibility of Effect Modification ANalyses (ICEMAN) applied to evaluate subgroup effect credibility; (2) iterative sensitivity analyses, including leave-one-out meta-analyses, to examine the robustness of the results; and (3) evidence certainty grading using the GRADEpro GDT software. To ensure methodological rigor, all procedures-including study selection, data extraction, quality assessment, and evidence evaluation-will be independently performed by two reviewers.

Discussion: This review will synthesize existing studies to evaluate the effects of gamified swallowing exercise on adults with dysphagia, thereby providing valuable reference for healthcare providers to promote the clinical practice of swallowing rehabilitation.

Systematic review registration: PROSPERO CRD42024617169.

Background and objectives: Although Pilates exercises are widely practiced worldwide, the available evidence regarding their metabolic intensity and energy cost remains limited and inconsistent. This study aimed to explore the metabolic equivalent (MET) and energy cost of Pilates exercises. As a secondary objective, we examined other measures commonly used in professional practice to monitor exercise intensity, such as heart rate and the rating of perceived exertion (RPE).

Methods: A systematic search was conducted in PubMed, CENTRAL, Embase, Web of Science, SPORTDiscus, and CINAHL (May 2024). The methodological quality of the studies was assessed using the Rosendal scale. For the meta-analysis, weighted averages were calculated for the following outcomes: METs, energy cost (kcal·min⁻¹), oxygen consumption (V̇O₂, ml·kg⁻¹·min⁻¹), heart rate (bpm), and RPE (Borg 6-20). The certainty of the evidence was assessed using the GRADE approach.

Results: Six studies met the inclusion criteria. Very low- to low-certainty evidence suggests that a typical Pilates session elicits, on average, 3.7 (95% CI: 3.1-4.3) METs, 3.8 (95% CI: 3.1-4.5) kcal·min⁻¹, V̇O₂ of 10.3 (95% CI: 8.1-12.6) ml·kg⁻¹·min⁻¹, heart rate of 108.6 (95% CI: 104.1-113.0) bpm, and RPE of 10.6 (95% CI: 9.3-12.0). However, sensitivity analyses excluding two studies with high risk of bias and without indirect calorimetry yielded lower and more conservative estimates of 3.0 (95% CI: 2.3-3.6) METs and 2.9 (95% CI: 2.3-3.6) kcal·min⁻¹, which should be considered the most methodologically reliable estimates available to date. The rest interval between sets and exercises emerged as a potential moderator, with durations ≤ 60 s associated with higher metabolic intensity.

Conclusion: Within the limits of the current and highly heterogeneous evidence base, Pilates appears to elicit light-to-moderate metabolic intensity. These conclusions are exploratory, and the estimates require confirmation through future well-controlled primary studies.

Systematic review registration: Prospero registration number: CRD42022370937.