Adjusted indirect comparison may be less biased than direct comparison for evaluating new pharmaceutical interventions

Adjusted indirect comparison may be less biased than direct comparison for evaluating new pharmaceutical interventions
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DOI:
10.1016/j.jclinepi.2007.06.006
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发表时间:
2008-05-01
影响因子:
7.2
通讯作者:
Lilford, R.
Lilford, R.
中科院分区:
医学2区
文献类型:
--
作者:
Song, F.;Harvey, I.;Lilford, R.

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目的:调查新药与传统药物干预荟萃分析中直接比较和调整间接比较之间的差异。研究设计和背景:在新药与传统药物的三项荟萃分析中,将直接比较结果与调整间接比较结果进行比较。这三个案例研究是(1)安非他酮与尼古丁替代疗法用于戒烟,(2)利培酮与氟哌啶醇用于治疗精神分裂症,以及(3)氟西汀与丙咪嗪用于治疗抑郁症。 结果:在所有三个案例中,通过头对头试验估计的新药效果往往大于通过调整的间接比较得出的效果。观察到的差异不能通过偶然性或调整后的间接比较中的偏差和异质性来令人满意地解释。这一观察结果以及对直接比较中可能存在的系统偏差的分析表明,间接方法可能产生偏差较小的结果。模拟发现,调整后的间接比较在某些情况下可以抵消偏差。结论:调整后的间接比较可用于交叉检验头对头随机试验结果的有效性和适用性。调整后的间接比较可能会提供比头对头随机试验更少偏差的结果,这一假设需要通过进一步的研究进行调查。 (c) 2008 Elsevier Inc. 保留所有权利。
Objective: To investigate discrepancies between direct comparison and adjusted indirect comparison in meta-analyses of new versus conventional pharmaceutical interventions.Study Design and Setting: Results of direct comparison were compared with results of adjusted indirect comparison in three metaanalyses of new versus conventional drugs. The three case studies are (1) bupropion versus nicotine replacement therapy for smoking cessation, (2) risperidone versus haloperidol for schizophrenia, and (3) fluoxetine versus imipramine for depressive disorders.Results: In all the three cases, effects of new drugs estimated by head-to-head trials tend to be greater than that by adjusted indirect comparisons. The observed discrepancies could not be satisfactorily explained by the play of chance or by bias and heterogeneity in adjusted indirect comparison. This observation, along with analysis of possible systematic bias in the direct comparisons, suggested that the indirect method might have produced less biased results. Simulations found that adjusted indirect comparison may counterbalance bias under certain circumstances.Conclusion: Adjusted indirect comparison could be used to cross-examine the validity and applicability of results from head-to-head randomized trials. The hypothesis that adjusted indirect comparison may provide less biased results than head-to-head randomized trials needs to be investigated by further research. (c) 2008 Elsevier Inc. All rights reserved.