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膀胱过度活动症症状患者药物治疗随机对照试验系列系统评价与网状Meta分析方案

Protocol for a Series of Systematic Reviews and Network Meta-analyses of Randomized Controlled Trials of Medications for Patients with Overactive Bladder Symptoms.

作者信息

van der Worp Henk, Puerto Nino Angie K, Blanker Marco H, Brignardello-Petersen Romina, Guyatt Gordon H, Tikkinen Kari A O

机构信息

Department of Primary and Long-term Care, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.

Faculty of Medicine, University of Helsinki, Helsinki, Finland.

出版信息

Eur Urol Open Sci. 2024 Sep 24;69:89-99. doi: 10.1016/j.euros.2024.08.006. eCollection 2024 Nov.

Abstract

Multiple randomized controlled trials (RCTs) have examined first-line pharmacological agents such as anticholinergics and β3 agonists for the management of overactive bladder symptoms (OAB). Although earlier systematic reviews and (network) meta-analyses aimed to summarize the evidence, a substantial number of trials were not included, so a comprehensive and methodologically rigorous evaluation of the comparative effectiveness of all first-line pharmacological treatments is lacking. We aim to conduct a series of systematic reviews and network meta-analyses (NMAs) for a comprehensive assessment of the effectiveness and safety of first-line pharmacological treatments for OAB. Eligible studies will include RCTs comparing anticholinergics and β3 agonists to one another or to placebo in adults with OAB or detrusor overactivity. Pairs of reviewers with methodological training will independently evaluate candidate studies to determine eligibility and extract relevant data. We will incorporate patient-important outcomes, including urinary urgency episodes, urgency incontinence episodes, any type of incontinence episodes, urinary frequency, nocturia, and adverse events. We will conduct the NMAs using a frequentist framework and a graph theory model for each outcome. Analysis will follow rigorous methodologies, including handling of missing data and assessment of the risk of bias. We will conduct sensitivity and subgroup analyses and will apply the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to rate evidence certainty. Our approach aims to address the knowledge gap in the treatment of OAB by synthesizing evidence from RCTs worldwide. We will employ robust statistical methods, including frequentist NMA, to general clinically relevant and patient-important insights. Sensitivity and subgroup analyses will enhance the robustness and generalizability of our findings. Our reviews strive to inform evidence-based decisions in the management of OAB, to ultimate improve patient outcomes. Our study results may guide health policy decisions, such as reimbursement policies, and future studies in functional urology. The protocol for the review series is registered on PROSPERO as CRD42023266915.

摘要

多项随机对照试验(RCT)已对一线药物治疗进行了研究,如抗胆碱能药物和β3激动剂用于治疗膀胱过度活动症(OAB)症状。尽管早期的系统评价和(网状)荟萃分析旨在总结证据,但大量试验未被纳入,因此缺乏对所有一线药物治疗的比较效果进行全面且方法严谨的评估。我们旨在进行一系列系统评价和网状荟萃分析(NMA),以全面评估OAB一线药物治疗的有效性和安全性。符合条件的研究将包括在患有OAB或逼尿肌过度活动的成年人中,比较抗胆碱能药物和β3激动剂相互之间或与安慰剂的RCT。经过方法学培训的评审员对将独立评估候选研究以确定其是否符合条件并提取相关数据。我们将纳入对患者重要的结局指标,包括尿急发作次数、急迫性尿失禁发作次数、任何类型的尿失禁发作次数、尿频、夜尿症和不良事件。我们将使用频率论框架和图论模型对每个结局指标进行NMA。分析将遵循严格的方法,包括处理缺失数据和评估偏倚风险。我们将进行敏感性和亚组分析,并将应用推荐分级评估、制定和评价(GRADE)方法来评定证据的确定性。我们的方法旨在通过综合来自全球RCT的证据来填补OAB治疗方面的知识空白。我们将采用稳健的统计方法,包括频率论NMA,以得出一般临床相关且对患者重要的见解。敏感性和亚组分析将增强我们研究结果的稳健性和可推广性。我们的综述力求为OAB管理中的循证决策提供信息,最终改善患者结局。我们的研究结果可能会指导卫生政策决策,如报销政策,以及功能性泌尿学的未来研究。该综述系列的方案已在PROSPERO上注册,注册号为CRD42023266915。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0328/11459702/cbb03943a47e/gr1.jpg

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