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针对相同病症的类似干预措施的临床试验和系统评价并不认为类似结果很重要：一项关于艾滋病毒/艾滋病的案例研究。

Clinical trials and systematic reviews addressing similar interventions for the same condition do not consider similar outcomes to be important: a case study in HIV/AIDS.

作者信息

Saldanha Ian J, Li Tianjing, Yang Cui, Owczarzak Jill, Williamson Paula R, Dickersin Kay

机构信息

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Room W6507-B, Baltimore, MD 21205, USA.

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Room E6011, Baltimore, MD 21205, USA.

出版信息

J Clin Epidemiol. 2017 Apr;84:85-94. doi: 10.1016/j.jclinepi.2017.02.005. Epub 2017 Feb 27.

DOI:10.1016/j.jclinepi.2017.02.005
PMID:28249722
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5441957/
Abstract

BACKGROUND

The usefulness of clinical trials and systematic reviews is compromised when they report different outcomes. We compared outcomes in reviews of HIV/AIDS and the trials included in the reviews.

STUDY DESIGN AND SETTING

We examined all Cochrane reviews of HIV/AIDS (as of June 2013) that included ≥1 trial and the trials that the reviews included. We compared outcomes within subgroups defined by type of intervention: clinical management, biomedical prevention, behavioral prevention, and health services.

RESULTS

We included 84 reviews that encompassed 524 trials. Although the median number of outcomes per trial (8) and per review (7.5) was similar, the trials reported a considerably greater number of unique outcomes than the reviews (779 vs. 218), ranging from 2.3 times greater (clinical management) to 5.4 times greater (behavioral prevention). High proportions of trial outcomes were not in any review: 68% (clinical management) to 83% (behavioral prevention). Lower proportions of review outcomes were not in any trial: 11% (clinical management) to 39% (health services).

CONCLUSION

Outcomes in trials and reviews are not well aligned for appropriate inclusion of trial results in reviews and meta-analyses. Differences in perspectives, goals, and constraints between trialists and reviewers may explain differences in outcomes they consider important.

摘要

背景

当临床试验和系统评价报告不同的结果时，它们的实用性会受到影响。我们比较了关于艾滋病毒/艾滋病的系统评价中的结果以及这些评价所纳入的试验中的结果。

研究设计与设置

我们检查了所有截至2013年6月的、纳入了≥1项试验的Cochrane艾滋病毒/艾滋病系统评价以及这些评价所纳入的试验。我们在根据干预类型定义的亚组内比较结果：临床管理、生物医学预防、行为预防和卫生服务。

结果

我们纳入了84项系统评价，这些评价涵盖了524项试验。尽管每项试验（8个）和每项系统评价（7.5个）的结果中位数相似，但试验报告的独特结果数量比系统评价多得多（779个对218个），范围从多2.3倍（临床管理）到多5.4倍（行为预防）。很大比例的试验结果未在任何系统评价中出现：68%（临床管理）至83%（行为预防）。较低比例的系统评价结果未在任何试验中出现：11%（临床管理）至39%（卫生服务）。

结论

试验和系统评价中的结果未能很好地契合，以便在系统评价和荟萃分析中适当纳入试验结果。试验者和评价者在观点、目标和限制方面的差异可能解释了他们认为重要的结果方面的差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d193/5441957/c016598bbddf/nihms855574f3a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d193/5441957/53577bbac350/nihms855574f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d193/5441957/12834a1dd40e/nihms855574f2a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d193/5441957/c016598bbddf/nihms855574f3a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d193/5441957/53577bbac350/nihms855574f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d193/5441957/12834a1dd40e/nihms855574f2a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d193/5441957/c016598bbddf/nihms855574f3a.jpg

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