What is meant by intention to treat analysis? Survey of published randomised controlled trials
What is meant by intention to treat analysis? Survey of published randomised controlled trials
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DOI：
10.1136/bmj.319.7211.670
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发表时间：
1999-09-11
影响因子：
--
通讯作者：
Campbell, F
中科院分区：
文献类型：
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作者：
Hollis, S;Campbell, F
目的评价4种大型医学期刊随机对照试验中意向处理分析的方法学质量。对1997年发表在《英国医学杂志》、《柳叶刀》、《美国医学会杂志》和《新英格兰医学杂志》上的所有随机对照试验报告进行设计调查。主要结果衡量处理随机分配偏差和丢失数据的方法。结果119篇(48%)报告提及意向处理分析。在这些研究中，12人排除了没有开始分配干预的任何患者，3人没有分析分配的所有随机受试者。5份报告明确指出没有偏离随机分配，其余99份报告似乎是按随机分配进行分析，但其中只有34份报告明确指出了这一点。89项试验(75%)在主要结果变量方面有一些缺失的数据。用于处理这一问题的方法普遍不足，有可能导致治疗效果的偏差29次(24%)试验中有29次(24%)的试验有超过10%的应答缺失，这一子集的缺失应答的处理方法相似。结论对整齐方法的意图描述和应用往往不充分。作者应该明确描述对随机分配偏差和丢失响应的处理，并讨论任何丢失响应的潜在影响。读者应该批判性地评估所报道的意向治疗分析的有效性。
Objectives To assess the methodological quality of intention to treat analysis as reported in randomised controlled trials in four large medical journals.Design Survey of all reports of randomised controlled trials published in 1997 in the BMJ, Lancet, JAMA, and New England Journal of Medicine.Main outcome measures Methods of dealing with deviations from random allocation and missing data.Results 119 (48%) of the reports mentioned intention to treat analysis. Of these, 12 excluded any patients who did not start the allocated intervention and three did not analyse all randomised subjects as allocated. Five reports explicitly stated that there were no deviations from random allocation, The remaining 99 reports: seemed to analyse according to random allocation, but only 34 of these explicitly stated this. 89 (75%) trials had some missing data on the primary outcome variable. The methods used to deal with this were generally inadequate, potentially leading to a biased treatment effect 29 (24%) trials had more than 10% of responses missing for the primary outcome, the methods of handling the missing responses were similar in this subset.Conclusions The intention to neat approach is often inadequately described and inadequately applied. Authors should explicitly describe the handling of deviations from randomised allocation and missing responses and discuss the potential effect of any missing response. Readers should critically assess the validity of reported intention to treat analyses.