Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project).

Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project).
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DOI:
10.1186/s13643-020-01516-1
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发表时间:
2020-11-20
期刊:
影响因子:
3.7
通讯作者:
Gluud C
Gluud C
中科院分区:
医学4区
文献类型:
--
作者:
Korang SK;Juul S;Nielsen EE;Feinberg J;Siddiqui F;Ong G;Klingenberg S;Veroniki AA;Bu F;Thabane L;Thomsen AR;Jakobsen JC;Gluud C

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严重急性呼吸综合征冠状病毒2型(SARS-CoV-2)导致2019年冠状病毒病(新冠肺炎),并已在全球迅速传播。目前正在进行几项评估潜在疫苗的人体随机临床试验。迫切需要一种活的、系统的审查,持续评估所有可用的新冠肺炎疫苗的益处和有害影响。我们将根据主要医学数据库(如MEDLINE、EMBASE、CENTAL)和临床试验登记从一开始就进行活的系统审查,以确定相关的随机临床试验。我们将每周更新一次文献搜索,以持续评估是否有新的证据可用。两名综述作者将独立提取数据并进行偏见风险评估。我们将对所有年龄段的参与者进行随机临床试验,将任何旨在预防新冠肺炎的疫苗(包括但不限于信使核糖核酸;脱氧核糖核酸;非复制型病毒载体;复制型病毒载体;灭活病毒;蛋白亚单位;树突状细胞;其他疫苗)与任何对照疫苗(安慰剂;“活性安慰剂”;不干预;标准护理;“主动”干预;新冠肺炎的另一种疫苗)进行比较。主要结果将是全原因死亡;被诊断为新冠肺炎;以及严重的不良事件。次要结果将是生活质量和非严重不良事件。活的系统评价将包括聚合数据元分析、试验序列分析、网络元分析和个别患者数据元分析。研究内偏差将使用Cochrane偏差风险工具进行评估。将使用建议、评估、发展和评价分级(等级)和对网络荟萃分析的可信度(电影)方法来评估证据的确定性。描述在试验搜索过程中确定的危害的观察性研究也将被包括在内,并单独进行描述和分析。新冠肺炎已经成为一种流行病,导致大量死亡。迫切需要对不同疫苗的有益和有害影响进行一次系统的评估。这种活生生的系统评价将定期为疫苗预防和这种高度流行的疾病的临床研究提供最佳实践。PROSPERO CRD42020196492在线版本包含可在10.1186/s13643-020-01516-1上查阅的补充材料。
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19) which has rapidly spread worldwide. Several human randomized clinical trials assessing potential vaccines are currently underway. There is an urgent need for a living systematic review that continuously assesses the beneficial and harmful effects of all available vaccines for COVID-19. We will conduct a living systematic review based on searches of major medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries from their inception onwards to identify relevant randomized clinical trials. We will update the literature search once a week to continuously assess if new evidence is available. Two review authors will independently extract data and conduct risk of bias assessments. We will include randomized clinical trials comparing any vaccine aiming to prevent COVID-19 (including but not limited to messenger RNA; DNA; non-replicating viral vector; replicating viral vector; inactivated virus; protein subunit; dendritic cell; other vaccines) with any comparator (placebo; “active placebo;” no intervention; standard care; an “active” intervention; another vaccine for COVID-19) for participants in all age groups. Primary outcomes will be all-cause mortality; a diagnosis of COVID-19; and serious adverse events. Secondary outcomes will be quality of life and non-serious adverse events. The living systematic review will include aggregate data meta-analyses, trial sequential analyses, network meta-analyses, and individual patient data meta-analyses. Within-study bias will be assessed using Cochrane risk of bias tool. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) and Confidence in Network Meta-Analysis (CINeMA) approaches will be used to assess certainty of evidence. Observational studies describing harms identified during the search for trials will also be included and described and analyzed separately. COVID-19 has become a pandemic with substantial mortality. A living systematic review assessing the beneficial and harmful effects of different vaccines is urgently needed. This living systematic review will regularly inform best practice in vaccine prevention and clinical research of this highly prevalent disease. PROSPERO CRD42020196492 The online version contains supplementary material available at 10.1186/s13643-020-01516-1.
DOI: 10.1056/nejmc2008043
发表时间: 2020-05-07
影响因子: 158.5
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影响因子: 2.8
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