Outcome measures in rheumatoid arthritis randomised trials over the last 50 years.

Outcome measures in rheumatoid arthritis randomised trials over the last 50 years.
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DOI:
10.1186/1745-6215-14-324
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发表时间:
2013-10-09
期刊:
影响因子:
2.5
通讯作者:
Williamson PR
Williamson PR
中科院分区:
医学4区
文献类型:
--
作者:
Kirkham JJ;Boers M;Tugwell P;Clarke M;Williamson PR

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在临床试验中测量和报告的标准化结局集的开发和应用有可能提高研究的效率和价值。目前最值得注意的结果集之一始于近20年前:世界卫生组织和国际流变学协会联盟的类风湿性关节炎临床试验核心结果集,源于OMERACT(流变学结果测量)倡议。本研究通过随机试验评估了该核心结局集在风湿病学中的应用。对通过科克伦图书馆(截至2012年9月)确定的350项治疗类风湿性关节炎的随机试验进行了观察性综述。对这些试验的报告进行了评价,以确定报告全套核心结局的试验比例是否随时间推移而出现趋势。在核心集发表后进行试验的研究人员被联系,以评估他们对核心集的认识,并收集未将完整核心集纳入研究的原因。自引入类风湿关节炎核心结局集以来,核心结局集测量的一致性有所改善,尽管测量工具的选择仍然存在差异。大多数回复的试验者表示,他们将考虑在设计新的试验时使用核心结果集。这项观察性综述表明,在类风湿关节炎中进行试验的试验者中,有更高比例的人现在正在测量类风湿关节炎的核心结局集。核心成果集有可能改善卫生保健的证据基础,但必须考虑在相关社区传播其可用性的方法。
The development and application of standardised sets of outcomes to be measured and reported in clinical trials have the potential to increase the efficiency and value of research. One of the most notable of the current outcome sets began nearly 20 years ago: the World Health Organization and International League of Associations for Rheumatology core set of outcomes for rheumatoid arthritis clinical trials, originating from the OMERACT (Outcome Measures in Rheumatology) Initiative. This study assesses the use of this core outcome set by randomised trials in rheumatology. An observational review was carried out of 350 randomised trials for the treatment of rheumatoid arthritis identified through The Cochrane Library (up to and including September 2012 issue). Reports of these trials were evaluated to determine whether or not there were trends in the proportion of trials reporting on the full set of core outcomes over time. Researchers who conducted trials after the publication of the core set were contacted to assess their awareness of it and to collect reasons for non-inclusion of the full core set of outcomes in the study. Since the introduction of the core set of outcomes for rheumatoid arthritis, the consistency of measurement of the core set of outcomes has improved, although variation in the choice of measurement instrument remains. The majority of trialists who responded said that they would consider using the core outcome set in the design of a new trial. This observational review suggests that a higher percentage of trialists conducting trials in rheumatoid arthritis are now measuring the rheumatoid arthritis core outcome set. Core outcome sets have the potential to improve the evidence base for health care, but consideration must be given to the methods for disseminating their availability amongst the relevant communities.
DOI: 10.1371/journal.pone.0003081
发表时间: 2008-08-28
期刊: PLOS ONE
影响因子: 3.7
作者:
Dwan, Kerry;Altman, Douglas G.;Williamson, Paula R.
通讯作者: Williamson, Paula R.
DOI: 10.1136/bmj.c365
发表时间: 2010-02-15
影响因子: 105.7
作者:
Kirkham, Jamie J.;Dwan, Kerry M.;Williamson, Paula R.
通讯作者: Williamson, Paula R.
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DOI: 10.1186/1745-6215-8-39
发表时间: 2007-11-26
期刊: TRIALS
影响因子: 2.5
作者:
Clarke, Mike
通讯作者: Clarke, Mike
DOI: 10.1186/1745-6215-8-38
发表时间: 2007-11-26
期刊: Trials
影响因子: 2.5
作者:
Tugwell P;Boers M;Brooks P;Simon L;Strand V;Idzerda L
通讯作者: Idzerda L
DOI: 10.1038/jid.2010.303
发表时间: 2011-03-01
影响因子: 6.5
作者:
Schmitt, Jochen;Langan, Sinead;Williams, Hywel C.
通讯作者: Williams, Hywel C.