Current practice in methodology and reporting of the sample size calculation in randomised trials of hip and knee osteoarthritis: a protocol for a systematic review.
Current practice in methodology and reporting of the sample size calculation in randomised trials of hip and knee osteoarthritis: a protocol for a systematic review.
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DOI：
10.1186/s13063-017-2209-8
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发表时间：
2017-10-10
期刊：
影响因子：
2.5
通讯作者：
Cook JA
中科院分区：
文献类型：
--
作者：
Copsey B;Dutton S;Fitzpatrick R;Lamb SE;Cook JA
随机对照试验（RCTs）设计的一个关键方面是确定样本量。适当计算试验样本量是很重要的。所需的样本量会因临床领域而异，例如，由于疾病的流行程度和主要结局的选择。此外，它还取决于计算中假设的目标差的选择。本研究聚焦于髋关节和膝关节骨关节炎人群，旨在系统地回顾如何确定骨关节炎试验的试验规模，以什么为基础，以及这些方面的报道如何。检索多个电子数据库（Medline, Cochrane library， CINAHL， EMBASE, PsycINFO， PEDro和AMED），以确定2016年发表的关于髋关节和膝关节骨关节炎的随机对照试验的文章。文章的合格性和数据将由两位审稿人独立筛选。将提取有关研究特征（设计、人群、干预和对照治疗）、主要结局、选定的样本量和理由、用于计算样本量的参数（包括对照组的治疗效果、主要结局的变异性水平、随访失取率）的数据。将使用适当的汇总统计（例如n和%，中位数和四分位数范围）对研究中的数据进行汇总。报告样本大小计算的每个关键组成部分的研究的比例将被提出。将测试样本量计算的可重复性。本系统综述的研究结果将总结当前髋关节和膝关节骨关节炎试验中样本量计算的实践。它还将提供证据，说明报告样本量计算的完整性、所选样本量的可重复性以及计算中使用的数值的基础。由于这项审查没有资格在PROSPERO上注册，摘要信息被上传到Figshare，使公众可以访问，以避免在其他福利中不必要的重复（https://doi.org/10.6084/m9.figshare.5009027.v1）；2017年1月17日注册。本文的在线版本（doi:10.1186/s13063-017-2209-8）包含补充资料，仅供授权用户使用。
A key aspect of the design of randomised controlled trials (RCTs) is determining the sample size. It is important that the trial sample size is appropriately calculated. The required sample size will differ by clinical area, for instance, due to the prevalence of the condition and the choice of primary outcome. Additionally, it will depend upon the choice of target difference assumed in the calculation. Focussing upon the hip and knee osteoarthritis population, this study aims to systematically review how the trial size was determined for trials of osteoarthritis, on what basis, and how well these aspects are reported. Several electronic databases (Medline, Cochrane library, CINAHL, EMBASE, PsycINFO, PEDro and AMED) will be searched to identify articles on RCTs of hip and knee osteoarthritis published in 2016. Articles will be screened for eligibility and data extracted independently by two reviewers. Data will be extracted on study characteristics (design, population, intervention and control treatments), primary outcome, chosen sample size and justification, parameters used to calculate the sample size (including treatment effect in control arm, level of variability in primary outcome, loss to follow-up rates). Data will be summarised across the studies using appropriate summary statistics (e.g. n and %, median and interquartile range). The proportion of studies which report each key component of the sample size calculation will be presented. The reproducibility of the sample size calculation will be tested. The findings of this systematic review will summarise the current practice for sample size calculation in trials of hip and knee osteoarthritis. It will also provide evidence on the completeness of the reporting of the sample size calculation, reproducibility of the chosen sample size and the basis for the values used in the calculation. As this review was not eligible to be registered on PROSPERO, the summary information was uploaded to Figshare to make it publicly accessible in order to avoid unnecessary duplication amongst other benefits (https://doi.org/10.6084/m9.figshare.5009027.v1); Registered January 17, 2017. The online version of this article (doi:10.1186/s13063-017-2209-8) contains supplementary material, which is available to authorized users.
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DOI：
10.1136/bmj.e813
发表时间：
2012-02-14
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Bafeta A;Dechartres A;Trinquart L;Yavchitz A;Boutron I;Ravaud P
通讯作者：
Ravaud P
DOI：
10.1136/bmj.f2820
发表时间：
2013-06-18
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Cook JA;McCulloch P;Blazeby JM;Beard DJ;Marinac-Dabic D;Sedrakyan A;IDEAL Group
通讯作者：
IDEAL Group
影响因子：
2.7
作者：
Cook, Jonathan A.;Hislop, Jennifer M.;Vale, Luke D.
通讯作者：
Vale, Luke D.
影响因子：
2.5
作者：
Cook, Jonathan A.;Hislop, Jenni;Vale, Luke D.
通讯作者：
Vale, Luke D.
影响因子：
--
作者：
ALTMAN, DG
通讯作者：
ALTMAN, DG