Randomised controlled trials in Africa of HIV and AIDS: descriptive study and spatial distribution

Randomised controlled trials in Africa of HIV and AIDS: descriptive study and spatial distribution
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DOI:
10.1136/bmj.331.7519.742
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发表时间:
2005-10-01
影响因子:
--
通讯作者:
Volmink, J
Volmink, J
中科院分区:
医学1区
文献类型:
--
作者:
Siegfried, N;Clarke, M;Volmink, J

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目的识别和描述在非洲进行的关于艾滋病毒和艾滋病的随机对照试验,并使用精确的地理坐标绘制其空间分布图。设计全部或部分在非洲进行并在2004年之前报告的试验数据库的构建和分析。和LILACS。结果我们的全面搜索产生了284个不同的记录,可能有资格列入数据库。其中,150篇文章报告了1987年至2003年期间发表或报告的77项合格试验。仅从CENTRAL数据库中识别出7项试验。在撒哈拉以南非洲48个国家中的18个国家进行了试验。在北非没有进行过。只有19个国家的首席调查员在非洲国家。42项试验评估预防,35项评估治疗。大多数研究由非洲以外的政府机构资助(n = 43),其中16项由制药业提供部分支助。制药业为另外18项试验提供了全部或部分支助。只有43项试验报告进行了把握度计算以确定样本量。有19和17 trials.Conclusion在非洲进行的艾滋病毒/艾滋病试验相对较少的数量是不相称的疾病负担的伦理批准或知情同意没有提到。作为前瞻性试验注册的辅助手段,地理绘图是研究人员和决策者跟踪现有和未来试验的有用工具。
Objectives To identify and describe randomised controlled trials on HIV and AIDS conducted in Africa and to map their spatial distribution using exact geographic coordinates.Design Construction and analysis of a database of trials conducted wholly or partly in Africa and reported before 2004.Data sources CENTRAL, Medline, Embase, and LILACS.Results Our comprehensive search yielded 284 distinct records that were potentially eligible for inclusion in the database. Of these, 150 articles reported on 77 eligible trials published or reported from 1987 to 2003. Seven trials were identified exclusively from the CENTRAL database. Trials were conducted in 18 of 48 countries in sub-Saharan Africa. None were conducted in north Africa. Only 19 had a principal investigator located in an African country. Forty two trials assessed prevention and 35 assessed treatment. Most studies were funded by government agencies outside Africa (n = 43), with the pharmaceutical industry providing partial support to 16 of these. The pharmaceutical industry provided full or partial support to a further 18 trials. Only 43 trials reported conducting a power calculation for determining sample size. There was no mention of ethical approval or informed consent in 19 and 17 trials, respectively.Conclusion The relatively small number of HIV/AIDS trials conducted in Africa is not commensurate with the burden of disease. Geographical mapping as an adjunct to prospective trial registration is a useful tool for researchers and decision makers to track existing and future trials.