Modified intention to treat reporting in randomised controlled trials: systematic review.
Modified intention to treat reporting in randomised controlled trials: systematic review.
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DOI：
10.1136/bmj.c2697
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发表时间：
2010-06-14
期刊：
影响因子：
--
通讯作者：
Montedori A
中科院分区：
文献类型：
--
作者：
Abraha I;Montedori A
目的确定采用改良意向治疗方法的随机对照试验的发生率和特点，以及如何描述该方法。设计系统性综述。数据来源：PubMed、Embase、Cochrane对照试验中央登记处、ISI Web of Knowledge、Ovid、Highwire Press、Science-Direct、Ingenta、Medscape、BioMed Central、Springer和Wiley，从最初到2006年12月。主要结果指标报告了使用改良意向治疗方法的试验的发生率，以及如何描述该方法(根据偏离意向治疗方法的类型和数量进行分类)。结果475个随机对照试验报告使用了改良的意向处理分析。其中，76篇(16%)发表在五种高引用率的普通医学期刊上。在Medline收录的期刊上发表的报告使用改良意向治疗的所有试验的发生率从1982年至2006年的0.006%增加到2002年至2006年的0.5%(P<；0.001为线性趋势)。当在每个试验中检查修改后的治疗意图的描述时，192(40%)报告偏离治疗意图的一种类型，261(55%)报告两种或两种以上的类型，22(5%)没有描述任何类型。在266例(56%)试验中，偏差与所接受的治疗有关，196例(41%)与基线后评估有关，118例(25%)与基线评估有关，108例(23%)与目标条件有关，23例(5%)与随访有关。在380个(80%)试验中发生了随机后排除试验。在352项优势试验中，有270项(77%)报告的结果有利于研究中的药物。所有123个使用等同或非劣势方法来调查干预措施的试验报告的结果都支持他们的假设。结论：医学文献中越来越多地发表了使用改良治疗意向的随机对照试验。对这种方法的描述含糊不清，可能涵盖任何类型的排除说明，如遗漏数据和偏离议定书。关于随机化后排除的明确声明应该取代修改的治疗意图的模棱两可的术语。
Objectives To determine the incidence and characteristics of randomised controlled trials that report using the modified intention to treat approach, and how the approach is described. Design Systematic review. Data sources PubMed, Embase, Cochrane central register of controlled trials, ISI Web of Knowledge, Ovid, HighWire Press, Science-Direct, Ingenta, Medscape, BioMed Central, Springer, and Wiley, from inception to December 2006. Main outcome measures Incidence of trials in which use of modified intention to treat was reported, and how the approach was described (classified according to the type and number of deviations from the intention to treat approach). Results 475 randomised controlled trials reported use of a modified intention to treat analysis. Of these, 76 (16%) were published in five highly cited general medical journals. The incidence of all trials that reported use of modified intention to treat published in journals indexed in Medline increased from 0.006% in 1982-6 to 0.5% in 2002-6 (P<0.001 for linear trend). When the description of the modified intention to treat was examined in each trial, 192 (40%) reported one type of deviation from the intention to treat approach, 261 (55%) reported two or more types, and 22 (5%) did not describe any type. In 266 (56%) of the trials the deviation was related to the treatment received, in 196 (41%) to a post baseline assessment, in 118 (25%) to a baseline assessment, in 108 (23%) to a target condition, and in 23 (5%) to follow-up. Post-randomisation exclusions occurred in 380 (80%) trials. The results reported by 270 of the 352 (77%) superiority trials favoured the drug under investigation. All of the 123 trials using equivalence or non-inferiority methods to investigate interventions reported results that favoured their assumptions. Conclusions Randomised controlled trials that report using a modified intention to treat are increasingly being published in the medical literature. The descriptions of such an approach were ambiguous, and may cover any type of descriptions for exclusion, such as missing data and deviation from protocol. Explicit statements about post-randomisation exclusions should replace the ambiguous terminology of modified intention to treat.
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影响因子：
168.9
作者：
Chan, AW;Altman, DG
通讯作者：
Altman, DG
影响因子：
45.3
作者：
Berek, JS;Taylor, PT;Nicodemus, CF
通讯作者：
Nicodemus, CF
影响因子：
105.7
作者：
Chan, AW;Altman, DG
通讯作者：
Altman, DG
DOI：
10.1136/bmj.b3244
发表时间：
2009-09-07
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Nüesch E;Trelle S;Reichenbach S;Rutjes AW;Bürgi E;Scherer M;Altman DG;Jüni P
通讯作者：
Jüni P
影响因子：
105.7
作者：
Fergusson, D;Aaron, SD;Hébert, P
通讯作者：
Hébert, P