Heinz Judith, Röver Christian, Furaijat Ghefar, Kaußner Yvonne, Hummers Eva, Debray Thomas, Hay Alastair D, Heytens Stefan, Vik Ingvild, Little Paul, Moore Michael, Stuart Beth, Wagenlehner Florian, Kronenberg Andreas, Ferry Sven, Monsen Tor, Lindbaek Morten, Friede Tim, Gagyor Ildiko
Department of Medical Statistics, University Medical Center Goettingen, Goettingen, Germany
Department of Medical Statistics, University Medical Center Goettingen, Goettingen, Germany.
BMJ Open. 2020 Oct 1;10(10):e035883. doi: 10.1136/bmjopen-2019-035883.
Uncomplicated urinary tract infection (UTI) in women is a common reason to present in general practice and is usually treated with antibiotics to reduce symptom severity and duration. Results of recent clinical trials indicate that non-antibiotic treatment approaches can also be effective. However, it remains unclear which patients would benefit from antibiotic treatment and which can effectively and safely be treated without antibiotics. This systematic review and meta-analysis aims to estimate the effect of treatment strategies to reduce antibiotic use in comparison with immediate antibiotic treatment and to identify prognostic factors and moderators of treatment effects. A further aim is to identify subgroups of patients benefiting from a specific therapy.
A systematic literature search will be performed to identify randomised controlled trials which investigated the effect of treatment strategies to reduce antibiotic use in female adults with uncomplicated UTI compared with immediate antibiotic treatment. Therefore, the primary outcome of the meta-analysis is incomplete recovery. Anonymised individual patient data (IPD) will be collected. Aggregate data will be used for pairwise comparisons of treatment strategies using meta-analysis models with random effects accounting for potential between-study heterogeneity. Potential effect moderators will be explored in meta-regressions. For IPD, generalised linear mixed models will be used, which may be adjusted for baseline characteristics. Interactions of baseline variables with treatment effects will be explored. These models will be used to assess direct comparisons of treatment, but might be extended to networks.
The local institutional review and ethics board judged the project a secondary analysis of existing anonymous data which meet the criteria for waiver of ethics review. Dissemination of the results will be via published scientific papers and presentations. Key messages will be promoted for example, via social media or press releases.
CRD42019125804.
女性单纯性尿路感染（UTI）是基层医疗中常见的就诊原因，通常使用抗生素治疗以减轻症状严重程度和缩短病程。近期临床试验结果表明，非抗生素治疗方法也可能有效。然而，尚不清楚哪些患者会从抗生素治疗中获益，哪些患者可以在不使用抗生素的情况下得到有效且安全的治疗。本系统评价和荟萃分析旨在评估与立即使用抗生素治疗相比，减少抗生素使用的治疗策略的效果，并确定治疗效果的预后因素和调节因素。另一个目的是确定从特定治疗中获益的患者亚组。
将进行系统的文献检索，以识别随机对照试验，这些试验研究了与立即使用抗生素治疗相比，减少成年女性单纯性UTI抗生素使用的治疗策略的效果。因此，荟萃分析的主要结局是未完全恢复。将收集匿名的个体患者数据（IPD）。汇总数据将用于使用考虑潜在研究间异质性的随机效应荟萃分析模型对治疗策略进行成对比较。将在荟萃回归中探索潜在的效应调节因素。对于IPD，将使用广义线性混合模型，该模型可能会根据基线特征进行调整。将探索基线变量与治疗效果的相互作用。这些模型将用于评估治疗的直接比较，但可能会扩展到网络。
当地机构审查和伦理委员会将该项目判定为对符合伦理审查豁免标准的现有匿名数据的二次分析。结果将通过发表的科学论文和报告进行传播。关键信息将通过例如社交媒体或新闻稿等方式进行推广。
PROSPERO注册号：CRD42019125804。
