Randomized controlled trials (RCTs)

随机对照试验 (RCTs)
  • 文章类型: Journal Article
    背景:薄型子宫内膜(TE)是临床实践中女性不孕的常见原因。富血小板血浆(PRP)疗法成为薄型子宫内膜的一种新的治疗方法;然而,其临床应用仍存在争议。本荟萃分析旨在通过相关随机对照试验(RCTs)评估子宫内自体PRP输注对子宫内膜薄型患者的治疗效果。
    方法:我们系统地搜索了从成立到2024年6月在PubMed等数据库中以英文发表的研究,科克伦图书馆,Embase,WebofScience,和MEDLINE。搜索词包括\"富血小板血浆,“薄薄的子宫内膜,“\”子宫内膜厚度,“\”不孕症,\"\"怀孕,\"\"复制,\"和\"不良反应\"。通过搜索确定的随机对照试验进行系统评价和荟萃分析,并使用基于异质性的固定效应或随机效应模型对数据进行分析。
    结果:共纳入8项RCTs,涉及678例子宫内膜薄型患者。与对照组相比,接受PRP输注的患者的子宫内膜厚度明显优于对照组(MD:1.23,95CI:0.87至1.59,P=0.000),临床妊娠率(RR:2.04,95CI:1.52~2.76,P=0.000),活产率(RR:2.46;95CI:1.57至3.85,P=0.000),周期取消率(RR:0.46,95CI:0.23至0.93,P=0.000),胚胎着床率(RR:2.71;95CI:1.91~3.84,P=0.000)。自然流产率无统计学意义(RR:0.85,95CI:0.40~1.78,P=0.659),两组间化学妊娠率(RR:1.84,95CI:0.72~4.72,P=0.204)和子宫内膜血管改善率(RR:1.10;95CI:0.89~1.38,P=0.367)。这项研究的局限性包括,我们只包括了文学研究的单一术语,样本量和异质性可能导致标准偏差。
    结论:宫内灌注PRP可能是子宫内膜薄型的一种安全有效的治疗方法。进一步的高品质,大样本,需要随机对照试验来验证我们结果的可靠性.
    背景:审查协议已在PROSPERO上注册,注册号为CRD42023490421,并且在注册时没有对提供的信息进行任何修改。
    BACKGROUND: Thin endometrium (TE) is a common cause of female infertility in clinical practice. Platelet-rich Plasma (PRP) therapy becomes a novel treatment for thin endometrium; however, its clinical application remains controversial. This meta-analysis aims to evaluate the therapeutic effects of intrauterine autologous PRP infusion in women with thin endometrium through relevant randomized controlled trials (RCTs).
    METHODS: We systematically searched studies published in English from inception until June 2024 in databases such as PubMed, The Cochrane Library, Embase, Web of Science, and MEDLINE. Search terms included \"Platelet-Rich Plasma,\" \"thin endometrium,\" \"endometrial thickness,\" \"infertility,\" \"pregnancy,\" \"reproduction,\" and \"adverse reactions\". RCTs identified through the search were subjected to systematic review and meta-analysis, and data were analyzed using fixed-effects or random-effects models based on heterogeneity.
    RESULTS: Eight RCTs involving 678 patients with thin endometrium were included. Patients receiving PRP infusion demonstrated significantly superior outcomes compared to the control group in endometrial thickness (MD: 1.23, 95%CI: 0.87 to 1.59, P = 0.000), clinical pregnancy rate (RR: 2.04, 95%CI: 1.52 to 2.76, P = 0.000), live birth rate (RR: 2.46; 95%CI: 1.57 to 3.85, P = 0.000), cycle cancellation rate (RR: 0.46, 95%CI: 0.23 to 0.93, P = 0.000), and embryo implantation rate (RR: 2.71; 95%CI: 1.91 to 3.84, P = 0.000). There were no statistically significance in spontaneous abortion rate (RR: 0.85, 95%CI: 0.40 to 1.78, P = 0.659), chemical pregnancy rate (RR: 1.84, 95%CI: 0.72 to 4.72, P = 0.204) and endometrial vascular improvement rate (RR: 1.10; 95%CI: 0.89 to 1.38, P = 0.367) between the two groups. The limitations of this study includes that, we only included single lauguage for literature research, the sample size and heterogeneity which could cause criteria bias.
    CONCLUSIONS: Intrauterine PRP infusion may be an effective and safe treatment for women with thin endometrium. Further high-quality, large-sample, randomized controlled trials are needed to validate the reliability of our results.
    BACKGROUND: The review protocol is registered on PROSPERO with registration number CRD42023490421, and no modifications were made to the information provided at registration.
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  • 文章类型: Journal Article
    高血压是中风患者中风复发的主要危险因素。家庭血压监测,在数字健康技术的推动下,在护士的领导下,可以改善这个高危人群的血压控制。然而,证据还没有定论。本研究方案概述了对当前文献的汇总分析,以评估护士主导的数字健康计划对中风患者家庭血压监测的有效性。
    我们将对一些主要的电子数据库进行全面搜索(例如,PubMed,EMBASE,科克伦图书馆,和CINAHL)和随机对照试验的试验注册表,该试验评估了护士主导的数字健康计划,用于中风患者的家庭血压监测。两名审稿人将独立筛选标题和摘要,回顾全文文章,提取数据,并使用修订后的Cochrane偏倚风险工具(RoB2.0)评估偏倚风险。主要结果指标将是从基线到干预期结束的收缩压和舒张压的变化。次要结果包括坚持该计划,患者满意度,和中风复发。将使用荟萃分析技术汇总和分析数据,如果合适。
    这项研究将提供全面的证据,证明护士主导的数字健康计划对中风患者家庭血压监测的有效性。这些发现可能对临床实践和卫生政策产生重大影响,可能为制定与高血压管理和卒中预防相关的指南和政策提供信息。
    通过汇集随机对照试验的结果,这项研究将为卒中患者的临床实践和卫生政策提供有力的证据基础.尽管存在潜在的局限性,如研究之间的异质性和发表偏倚的风险,严格的方法和全面的数据综合方法将确保结果的可靠性和有效性。结果将通过同行评审的出版物传播,并可能在相关会议上传播。
    https://doi.org/10.17605/OSF。IO/59XQA。
    UNASSIGNED: Hypertension is a major risk factor for stroke recurrence in stroke patients. Home blood pressure monitoring, facilitated by digital health technologies and led by nurses, may improve blood pressure control in this high-risk population. However, the evidence is not yet conclusive. This study protocol outlines a pooled analysis of the current literatures to evaluate the effectiveness of nurse-led digital health programs for home blood pressure monitoring in stroke patients.
    UNASSIGNED: We will conduct a comprehensive search of some major electronic databases (e.g., PubMed, EMBASE, Cochrane Library, and CINAHL) and trial registries for randomized controlled trials evaluating nurse-led digital health programs for home blood pressure monitoring in stroke patients. Two reviewers will independently screen titles and abstracts, review full-text articles, extract data, and assess risk of bias using the revised Cochrane risk-of-bias tool for randomized trials (RoB 2.0). The primary outcome measures will be changes in both systolic and diastolic blood pressure from baseline to the end of the intervention period. Secondary outcomes include adherence to the program, patient satisfaction, and stroke recurrence. Data will be pooled and analyzed using meta-analysis techniques, if appropriate.
    UNASSIGNED: This study will provide comprehensive evidence on the effectiveness of nurse-led digital health programs for home blood pressure monitoring in stroke patients. The findings could have substantial implications for clinical practice and health policy, potentially informing the development of guidelines and policies related to hypertension management and stroke prevention.
    UNASSIGNED: By pooling the results of randomized controlled trials, this study will offer a robust evidence base to inform clinical practice and health policy in the context of stroke patients. Despite potential limitations such as heterogeneity among studies and risk of publication bias, the rigorous methodology and comprehensive approach to data synthesis will ensure the reliability and validity of the findings. The results will be disseminated through a peer-reviewed publication and potentially at relevant conferences.
    UNASSIGNED: https://doi.org/10.17605/OSF.IO/59XQA.
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  • 文章类型: Journal Article
    本手稿研究了前瞻性现实世界/时间数据/证据(RWTD/E)和随机对照试验(RCT)的协同潜力,以丰富医疗保健研究和运营见解。特别关注它在肉瘤领域的影响。通过探索RWTD/E提供真实世界/时间的能力,细粒度的患者数据,它提供了关于医疗保健结果和交付的丰富视角,尤其是在复杂的肉瘤治疗领域。突出了RWTD/E的广阔现实/时间范围与RCT的结构化环境之间的互补性,本文展示了他们的综合实力,这有助于促进个性化医疗和人口健康管理的进步,通过晶状体肉瘤的治疗来举例说明。手稿进一步概述了方法创新,如目标试验仿真及其在提高RWTD/E的精度和适用性方面的意义,强调了这些进步在肉瘤治疗及其他方面的变革潜力。通过倡导将预期的RWTD/E战略纳入医疗保健框架,它旨在创建一个证据驱动的生态系统,显着提高患者的治疗效果和医疗保健效率,肉瘤治疗是这些发展的关键领域。
    This manuscript examines the synergistic potential of prospective real-world/time data/evidence (RWTD/E) and randomized controlled trials (RCTs) to enrich healthcare research and operational insights, with a particular focus on its impact within the sarcoma field. Through exploring RWTD/E\'s capability to provide real-world/time, granular patient data, it offers an enriched perspective on healthcare outcomes and delivery, notably in the complex arena of sarcoma care. Highlighting the complementarity between RWTD/E\'s expansive real-world/time scope and the structured environment of RCTs, this paper showcases their combined strength, which can help to foster advancements in personalized medicine and population health management, exemplified through the lens of sarcoma treatment. The manuscript further outlines methodological innovations such as target trial emulation and their significance in enhancing the precision and applicability of RWTD/E, underscoring the transformative potential of these advancements in sarcoma care and beyond. By advocating for the strategic incorporation of prospective RWTD/E into healthcare frameworks, it aims to create an evidence-driven ecosystem that significantly improves patient outcomes and healthcare efficiency, with sarcoma care serving as a pivotal domain for these developments.
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  • 文章类型: Journal Article
    目标:兴奋剂,例如哌醋甲酯(MPH)和苯丙胺,代表注意力缺陷/多动障碍(ADHD)的一线药物选择。随机对照试验(RCTs)已在组水平上证明了有益的效果,但无法确定与不同个体反应一致相关的特征。因此,需要更多的个性化方法。实验研究表明,对单剂量的神经生物学反应指示长期反应。目前尚不清楚这是否也适用于临床措施。方法:我们对RCTs进行了系统评价,以测试单剂量兴奋剂的临床反应与长期改善之间的关系。从MED-ADHD数据集中确定了可能合适的单剂量随机对照试验,欧洲ADHD指南组RCT数据集(https://med-adhd.org/),于2024年2月1日更新。使用Cochrane偏差风险(RoB)2.0工具进行质量评估。结果:总共63例单剂量随机对照试验(94%检测MPH,85%的儿童)被确认。其中,只有RCT的二次分析检验了急性和长期临床反应之间的相关性.这表明,在46名患有ADHD的儿童(89%的男性)中,单剂量MPH后的临床改善与4周MPH治疗后的症状改善显着相关。偏倚风险被评为中度。另一个RCT使用近红外光谱,因此不符合纳入标准,报告了22名患有ADHD的儿童(82%为男性)单剂量下的大脑变化与长期临床反应之间的关联。其余的随机对照试验仅报道了单剂量对神经心理学的影响,神经影像学,或神经生理学措施。结论:本系统综述强调了当前知识的重要差距。研究急性和长期反应可能与之相关,可以促进我们对兴奋剂作用机制的理解,并有助于开发分层方法以制定更量身定制的治疗策略。未来的研究需要调查潜在的年龄和性别相关的差异。
    Objectives: Stimulants, such as methylphenidate (MPH) and amphetamines, represent the first-line pharmacological option for attention-deficit/hyperactivity disorder (ADHD). Randomized controlled trials (RCTs) have demonstrated beneficial effects at a group level but could not identify characteristics consistently associated with varying individual response. Thus, more individualized approaches are needed. Experimental studies have suggested that the neurobiological response to a single dose is indicative of longer term response. It is unclear whether this also applies to clinical measures. Methods: We carried out a systematic review of RCTs testing the association between the clinical response to a single dose of stimulants and longer term improvement. Potentially suitable single-dose RCTs were identified from the MED-ADHD data set, the European ADHD Guidelines Group RCT Data set (https://med-adhd.org/), as updated on February 1, 2024. Quality assessment was carried out using the Cochrane Risk of Bias (RoB) 2.0 tool. Results: A total of 63 single-dose RCTs (94% testing MPH, 85% in children) were identified. Among these, only a secondary analysis of an RCT tested the association between acute and longer term clinical response. This showed that the clinical improvement after a single dose of MPH was significantly associated with symptom improvement after a 4-week MPH treatment in 46 children (89% males) with ADHD. The risk of bias was rated as moderate. A further RCT used near-infrared spectroscopy, thus did not meet the inclusion criteria, and reported an association between brain changes under a single-dose and longer term clinical response in 22 children (82% males) with ADHD. The remaining RCTs only reported single-dose effects on neuropsychological, neuroimaging, or neurophysiological measures. Conclusion: This systematic review highlighted an important gap in the current knowledge. Investigating how acute and long-term response may be related can foster our understanding of stimulant mechanism of action and help develop stratification approaches for more tailored treatment strategies. Future studies need to investigate potential age- and sex-related differences.
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  • 文章类型: Journal Article
    中风仍然是全球残疾的主要原因。护士主导的电子健康计划已成为改善中风幸存者功能结果和生活质量的潜在有效策略。然而,由于研究设计和试验间结局的差异性,需要进行汇总分析,以全面评估这些干预措施的疗效.该协议概述了汇总分析的方法,旨在综合来自随机对照试验(RCT)的证据,评估护士主导的针对中风患者的电子健康干预措施。
    此汇总分析将根据PRISMA指南进行。我们将包括评估护士主导的电子健康计划的RCT,并报告中风患者的功能结果或生活质量。全面搜索电子数据库,包括Pubmed,EMBASE,Cochrane图书馆,CINAHL,和PsycINFO将以预定义的搜索策略进行。研究选择将涉及筛选标题和摘要,然后使用明确的纳入和排除标准进行全文审查。数据提取将由两名审阅者独立进行。偏差风险将通过Cochrane偏差风险工具进行评估。此外,将使用GRADE方法评估每个结果的证据质量.荟萃分析将使用随机效应模型进行,异质性将使用I2统计量进行量化。亚组和敏感性分析将探索异质性的潜在来源。
    此汇总分析旨在对护士主导的电子健康计划在中风康复中的有效性提供细微差别的理解。利用全面的方法框架和等级工具来确保证据的稳健性和可靠性。调查预计患者预后会有不同的改善,强调个性化的潜力,可获得的电子健康干预措施,以提高患者参与度和治疗依从性。尽管干预措施的异质性和快速的技术进步带来了挑战,这些发现将通过将电子健康整合到标准护理中来影响临床路径,如果有证据证明。我们研究的深度和方法的严谨性具有启动医疗政策变化的潜力,倡导采用电子健康,并随后对其成本效益进行调查。最终,我们的目标是贡献财富,对新兴的数字健康领域的循证见解,对其在中风护理中的应用进行了基础评估。我们的数据预计会产生持久的影响,不仅指导即时的临床决策,而且还塑造未来卒中康复医疗策略的轨迹。
    标识符(CRD42024520100:https://www.crd.约克。AC.uk/prospro/display_record.php?RecordID=520100)。
    Stroke remains a leading cause of disability worldwide. Nurse-led eHealth programs have emerged as a potentially effective strategy to improve functional outcomes and quality of life in stroke survivors. However, the variability of study designs and outcomes measured across trials necessitates a pooled analysis to comprehensively assess the efficacy of these interventions. This protocol outlines the methodology for a pooled analysis that aims to synthesize evidence from randomized controlled trials (RCTs) evaluating nurse-led eHealth interventions for stroke patients.
    This pooled analysis will be conducted according to the PRISMA guidelines. We will include RCTs that evaluate nurse-led eHealth programs and report on functional outcomes or quality of life in stroke patients. Comprehensive searches of electronic databases including Pubmed, EMBASE, the Cochrane Library, CINAHL, and PsycINFO will be conducted with a predefined search strategy. Study selection will involve screening titles and abstracts, followed by full-text review using explicit inclusion and exclusion criteria. Data extraction will be undertaken independently by two reviewers. The risk of bias will be assessed through the Cochrane Risk of Bias tool. Additionally, the quality of evidence for each outcome will be evaluated using the GRADE approach. Meta-analyses will be performed using random-effects models, and heterogeneity will be quantified using the I2 statistic. Subgroup and sensitivity analyses will explore potential sources of heterogeneity.
    This pooled analysis is poised to provide a nuanced understanding of the effectiveness of nurse-led eHealth programs in stroke rehabilitation, leveraging a thorough methodological framework and GRADE tool to ensure robustness and reliability of evidence. The investigation anticipates diverse improvements in patient outcomes, underscoring the potential of personalized, accessible eHealth interventions to enhance patient engagement and treatment adherence. Despite the challenges posed by the heterogeneity of interventions and rapid technological advancements, the findings stand to influence clinical pathways by integrating eHealth into standard care, if substantiated by the evidence. Our study\'s depth and methodological rigor possess the potential to initiate changes in healthcare policy, advocating for the adoption of eHealth and subsequent investigations into its cost-efficiency. Ultimately, we aim to contribute rich, evidence-based insights into the burgeoning field of digital health, offering a foundational assessment of its applications in stroke care. Our data is expected to have a lasting impact, not only guiding immediate clinical decisions but also shaping the trajectory of future healthcare strategies in stroke recovery.
    Identifier (CRD42024520100: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=520100).
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  • 文章类型: Journal Article
    背景:骶神经神经调节(SNM)被认为是大便失禁(FI)的最佳二线治疗方法。然而,SNM涉及高成本并且需要高技能的操作者。经皮胫神经刺激(PTNS)已成为FI的替代治疗方式,产生不同的临床结果。我们进行了这项荟萃分析,以评估PTNS与假电刺激对FI的有效性和安全性。
    方法:PubMed,Embase,WebofScience,从2012年5月12日至2022年5月12日,搜索了Cochrane图书馆的研究。
    结果:本综述包括四项随机对照研究,共有439例成人FI患者(PTNS组300例,假电刺激组194例)。我们的荟萃分析显示,与对照组相比,PTNS在减少每周FI发作方面表现出更好的疗效(MD-1.6,95%CI-2.94至-0.26,p=0.02,I2=30%)。此外,PTNS组中更多的患者报告每周FI发作减少超过50%(RR0.73,95%CI0.57~0.94,p=0.02,I2=6%).然而,在FI生活质量(QoL)和StMark's失禁评分的任何方面均未观察到显著差异(MD-2.41,95%CI-5.1~0.27,p=0.08,I2=67%).重要的是,所有参与者均未报告与PTNS相关的严重不良事件.
    结论:我们的荟萃分析显示,PTNS在减少FI发作方面比假刺激更有效,并且导致报告每周FI发作减少超过50%的患者比例更高。
    BACKGROUND: Sacral nerve neuromodulation (SNM) has been considered the optimal second-line treatment for fecal incontinence (FI). However, SNM involves high cost and requires highly skilled operators. Percutaneous tibial nerve stimulation (PTNS) has emerged as an alternative treatment modality for FI, yielding varying clinical outcomes. We conducted this meta-analysis to evaluate the effectiveness and safety of PTNS compared to sham electrical stimulation for FI.
    METHODS: PubMed, Embase, Web of Science, and the Cochrane Library were searched for studies from May 12, 2012 to May 12, 2022.
    RESULTS: Four randomized controlled studies were included in this review, involving a total of 439 adult patients with FI (300 in the PTNS group and 194 in the sham electrical stimulation group). Our meta-analysis revealed that PTNS demonstrated superior efficacy in reducing weekly episodes of FI compared to the control groups (MD - 1.6, 95% CI - 2.94 to - 0.26, p = 0.02, I2 = 30%). Furthermore, a greater proportion of patients in the PTNS group reported more than a 50% reduction in FI episodes per week (RR 0.73, 95% CI 0.57-0.94, p = 0.02, I2 = 6%). However, no significant differences were observed in any domains of the FI Quality of Life (QoL) and St Mark\'s incontinence scores (MD - 2.41, 95% CI - 5.1 to 0.27, p = 0.08, I2 = 67%). Importantly, no severe adverse events related to PTNS were reported in any of the participants.
    CONCLUSIONS: Our meta-analysis revealed that PTNS was more effective than sham stimulation in reducing FI episodes and led to a higher proportion of patients reporting more than a 50% reduction in weekly FI episodes.
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  • 文章类型: Meta-Analysis
    中药注射剂(CMI)在中国被广泛用作宫颈癌的辅助治疗。然而,不同类型CMI的有效性仍不确定。
    为了评估CMI与放疗(RT)或同步放化疗(CCRT)结合使用时的有效性和安全性,特别是与顺铂(DDP)联合使用,多西他赛联合顺铂(DP),和紫杉醇加顺铂(TP)。
    在包括CNKI在内的数据库中搜索随机对照试验(RCT),万方,VIP,SinoMed,PubMed,科克伦图书馆,Embase,和WebofScience从成立到2023年9月。我们计算了95%置信区间的风险比和临床有效率(CER)的累积排序面积曲线(SUCRA)下的表面,通过Karnofsky性能状态(KPS),以及白细胞减少(LRR)和胃肠道反应(GRR)的发生率。
    包括47个RCT,包括九种CMI类型:Aidi,福方苦神,黄芪,Kangai(KA),康莱特(KLT),仁神多堂,神气扶正(SQFZ),申麦(SM),还有Yadanzi.KLT和KA可能是CER和KPS放疗的最佳选择,分别。KA和KLT是CER和GRR的RT+DDP的最佳选择,分别。KLT可能是CER的RT+DP和KPS和GRR的KA的最佳选择。SM和SQFZ可能是CER和LRR的RT+TP的最佳选择,分别。
    最佳建议取决于CMI是否与放疗或同步放化疗一起使用。需要更多高质量的RCT来进一步确认和更新现有证据。
    UNASSIGNED: Chinese medicine injections (CMIs) are widely used as adjuvant therapy for cervical cancer in China. However, the effectiveness of different types of CMIs remains uncertain.
    UNASSIGNED: To assess the effectiveness and safety of CMIs when used in conjunction with radiotherapy (RT) or concurrent chemoradiotherapy (CCRT), particularly in combination with cisplatin (DDP), docetaxel plus cisplatin (DP), and paclitaxel plus cisplatin (TP).
    UNASSIGNED: Randomized controlled trials (RCTs) were searched in databases including CNKI, WanFang, VIP, SinoMed, PubMed, Cochrane Library, Embase, and Web of Science from inception to September 2023. We calculated the risk ratio with a 95% confidence interval and the surface under the cumulative ranking area curve (SUCRA) for the clinical efficacy rate (CER), the efficacy rate by Karnofsky Performance Status (KPS), and the rates of leukopenia reduction (LRR) and gastrointestinal reactions (GRR).
    UNASSIGNED: Forty-seven RCTs were included, including nine CMI types: Aidi, Fufangkushen, Huangqi, Kangai (KA), Kanglaite (KLT), Renshenduotang, Shenqifuzheng (SQFZ), Shenmai (SM), and Yadanzi. KLT and KA were likely optimal choices with radiotherapy for CER and KPS, respectively. KA and KLT were optimal choices with RT + DDP for CER and GRR, respectively. KLT was the likely optimal choice with RT + DP for CER and KA for both KPS and GRR. SM and SQFZ were the likely optimal choices with RT + TP for CER and LRR, respectively.
    UNASSIGNED: The optimal recommendation depends on whether CMIs are used with radiotherapy or concurrent chemoradiotherapy. More high-quality RCTs are needed to confirm further and update the existing evidence.
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  • 文章类型: Journal Article
    患有并发健康状况的患者的治疗不能很好地通过(1)基于证据的临床指南,主要指定单一条件的治疗;(2)常规随机对照试验(RCTs),确定治疗是安全有效的。基于平均患者效应的临床决策可能不适合治疗患有多种疾病的患者,这些患者经历了可能是其个人情况所独有的负担和障碍。我们描述了如何将个性化(N-of-1)试验与自动平台和虚拟/远程技术集成在一起,以改善针对多病患者的以患者为中心的护理。为了说明,我们提出了一个假设的临床情景-2019年冠状病毒病(COVID-19)和癌症的幸存者长期患有失眠和疲劳.然后,我们将描述如何将常规RCT开发的四个标准阶段修改为个性化试验,并将其应用于多发病临床场景,概述如何调整和扩展个性化试验,以比较个性化试验与受试者间试验设计的益处,并解释个性化试验如何解决与常规试验不适合的多发病率相关的特殊问题。
    Treatment of patients who suffer from concurrent health conditions is not well served by (1) evidence-based clinical guidelines that mainly specify treatment of single conditions and (2) conventional randomized controlled trials (RCTs) that identify treatments as safe and effective on average. Clinical decision-making based on the average patient effect may be inappropriate for treatment of those with multimorbidity who experience burdens and obstacles that may be unique to their personal situation. We describe how the personalized (N-of-1) trials can be integrated with an automatic platform and virtual/remote technologies to improve patient-centered care for those living with multimorbidity. To illustrate, we present a hypothetical clinical scenario-survivors of both coronavirus disease 2019 (COVID-19) and cancer who chronically suffer from sleeplessness and fatigue. Then, we will describe how the four standard phases of conventional RCT development can be modified for personalized trials and applied to the multimorbidity clinical scenario, outline how personalized trials can be adapted and extended to compare the benefits of personalized trials versus between-subject trial design, and explain how personalized trials can address special problems associated with multimorbidity for which conventional trials are poorly suited.
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  • 文章类型: Systematic Review
    目的:评估一种使用自动化和众包的方法,以在实时系统评价(LSR)中识别和分类类风湿关节炎(RA)的随机对照试验(RCT)。
    方法:首先通过机器学习和CochraneCrowd筛选RA中RCT的数据库搜索记录,以排除非RCT,然后由受训审稿人使用人口,干预,比较和结果(PICO)注释器平台,以评估合格性并将试验分类为适当的审查。专家使用自定义在线工具解决了分歧。我们评估了效率收益,灵敏度,审稿人之间的准确性和评分者之间的一致性(kappa分数)。
    结果:来自42,452条记录,机器学习和Cochrane人群排除了28,777(68%),实习审稿人排除了4,529人(11%),专家排除了7200人(17%)。符合我们LSR条件的1,946条记录代表220条RCT,并纳入148/149(99.3%)已知的来自先前审查的符合条件的试验.虽然被排除在我们的LSR之外,6,420条记录被归类为RA中的其他RCT,以告知未来的审查。在RCT领域,学员的假阴性率最高(12%),尽管其中只有1.1%是主要记录。两名审稿人的Kappa评分范围从中等到实质一致(0.40到0.69)。
    结论:一种结合机器学习的筛选方法,众包,受训人员的参与大大减轻了专家评审人员的筛查负担,并且高度敏感。
    To evaluate an approach using automation and crowdsourcing to identify and classify randomized controlled trials (RCTs) for rheumatoid arthritis (RA) in a living systematic review (LSR).
    Records from a database search for RCTs in RA were screened first by machine learning and Cochrane Crowd to exclude non-RCTs, then by trainee reviewers using a Population, Intervention, Comparison, and Outcome (PICO) annotator platform to assess eligibility and classify the trial to the appropriate review. Disagreements were resolved by experts using a custom online tool. We evaluated the efficiency gains, sensitivity, accuracy, and interrater agreement (kappa scores) between reviewers.
    From 42,452 records, machine learning and Cochrane Crowd excluded 28,777 (68%), trainee reviewers excluded 4,529 (11%), and experts excluded 7,200 (17%). The 1,946 records eligible for our LSR represented 220 RCTs and included 148/149 (99.3%) of known eligible trials from prior reviews. Although excluded from our LSRs, 6,420 records were classified as other RCTs in RA to inform future reviews. False negative rates among trainees were highest for the RCT domain (12%), although only 1.1% of these were for the primary record. Kappa scores for two reviewers ranged from moderate to substantial agreement (0.40-0.69).
    A screening approach combining machine learning, crowdsourcing, and trainee participation substantially reduced the screening burden for expert reviewers and was highly sensitive.
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  • 文章类型: Journal Article
    随机对照试验(RCT)通常被认为是临床实践的金标准和基石。然而,21世纪发表的关于世界范围内眼科RCT的文献计量学研究尚未详细报道。本研究旨在对21世纪全球眼科RCT进行文献计量学研究和可视化分析。
    在WebofScience核心合集中搜索了2000年至2022年的全球眼科随机对照试验。出版物的数量,国家/地区,机构,作者,journal,并使用HistCite分析了RCT的研究热点,VOSviewer,CiteSpace,和Excel软件。
    来自83个国家/地区的2366个机构和90种期刊参与了1769项全球眼科随机对照试验的出版,美国在数量和研究领域处于领先地位,和Moorfields眼科医院贡献最多的出版物。眼科收到的出版物和共同引用数量最多。JeffreyS.Heier拥有最多的出版物,JostB.Jonas拥有最多的共同引用。全球眼科RCT的知识基础主要是视网膜病变,青光眼,干眼症(DED),和白内障,和抗血管内皮生长因子(VEGF)治疗(雷珠单抗),局部降眼压药物,激光小梁成形术.抗VEGF治疗年龄相关性黄斑变性(AMD),DME(糖尿病性黄斑水肿),DED,使用新的诊断工具,近视是最热门的研究热点。抗VEGF治疗,提示激光,曲安奈德,和维替泊芬光动力疗法治疗AMD,DME,和CNV(脉络膜新生血管形成),DED,近视,开角型青光眼是持续时间最长的研究热点。未来的研究热点可能是DED和近视的预防和控制。
    总的来说,21世纪全球眼科随机对照试验的数量一直在增长,地区和机构之间存在不平衡,需要更多的努力来提高数量,质量,以及发展中国家/地区高质量临床证据的全球影响。
    UNASSIGNED: Randomized controlled trials (RCTs) are often considered the gold standard and the cornerstone for clinical practice. However, bibliometric studies on worldwide RCTs of ophthalmology published in the 21st century have not been reported in detail yet. This study aims to perform a bibliometric study and visualization analysis of worldwide ophthalmologic RCTs in the 21st century.
    UNASSIGNED: Global ophthalmologic RCTs from 2000 to 2022 were searched in the Web of Science Core Collection. The number of publications, country/region, institution, author, journal, and research hotspots of RCTs were analyzed using HistCite, VOSviewer, CiteSpace, and Excel software.
    UNASSIGNED: 2366 institutions and 90 journals from 83 countries/regions participated in the publication of 1769 global ophthalmologic RCTs, with the United States leading in the number of volumes and research field, and the Moorfields Eye Hospital contributing to the most publications. Ophthalmology received the greatest number of publications and co-citations. Jeffrey S. Heier owned the most publications and Jost B. Jonas owned the most co-citations. The knowledge foundations of global ophthalmologic RCTs were mainly retinopathy, glaucoma, dry eye disease (DED), and cataracts, and anti-vascular endothelial growth factor (VEGF) therapy (ranibizumab), topical ocular hypotensive medication, laser trabeculoplasty. Anti-VEGF therapy for age-related macular degeneration (AMD), DME (diabetic macular edema), and DED, the use of new diagnostic tools, and myopia were the hottest research highlights. Anti-VEGF therapy, prompt laser, triamcinolone, and verteporfin photodynamic therapy for AMD, DME, and CNV (choroidal neovascularization), DED, myopia, and open-angle glaucoma were the research hotspots with the longest duration. The future research hotspots might be DED and the prevention and control of myopia.
    UNASSIGNED: Overall, the number of global ophthalmologic RCTs in the 21st century was keeping growing, there was an imbalance between the regions and institutions, and more efforts are required to raise the quantity, quality, and global impact of high-quality clinical evidence in developing countries/regions.
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