Eligibility criteria for HIV clinical trials and generalizability of results: the gap between published reports and study protocols
Eligibility criteria for HIV clinical trials and generalizability of results: the gap between published reports and study protocols
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DOI：
10.1097/01.aids.0000189866.67182.f7
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发表时间：
2005-11-04
期刊：
影响因子：
3.8
通讯作者：
Greenblatt, RM
中科院分区：
文献类型：
--
作者：
Gandhi, M;Ameli, N;Greenblatt, RM
目的：随机对照临床试验（RCT）结果对“真实的世界”情况的适用性取决于试验参与者与一般患者人群的可比性。临床医生有必要充分披露试验入组标准，以评估普遍性。我们试图评估的影响，在艾滋病临床试验组（ACTG）和社区计划的艾滋病临床研究（CPCRA）trial networks.Design和方法：资格标准进行了比较，在完整的协议中列出的标准，从这32个NIH资助的艾滋病随机对照试验的出版物中的32个主要的艾滋病随机对照试验的普遍性和披露率。然后，我们将这些标准应用于妇女的机构间艾滋病毒研究（WIHS），最大的队列研究艾滋病毒感染的妇女在US.Results：当应用于WIHS，从协议的资格标准排除0-67.6%（中位数42%）的WIHS参与者（50.6%从ACTG试验排除）。出版物中的合格性标准排除了0-62%（中位数19.6%）的WIHS（21.2%从ACTC试验中排除）。妇女在WIHS似乎不符合资格参加试验的人数在出版物中列出的每个登记标准平均只有60%的那些实际上排除的protocols.Conclusions的基础上：我们发现，HIV RCT的资格标准排除了很大比例的一个代表性队列的HIV感染的妇女参加试验。此外，试验出版物在披露合格性标准方面没有充分反映方案。试验方法的标准化和充分披露将使临床医生和研究人员能够更全面地评估结果对患者人群的普遍性。(c)2005年利平科特威廉姆斯&威尔金斯。
Objective: Applicability of randomized controlled clinical trial (RCT) results to 'real world' situations is dependent on the comparability of trial participants to general patient populations. A full disclosure of criteria employed for trial enrollment is necessary for clinicians to assess generalizability. We sought to assess both the impact on generalizability and the disclosure rate of enrollment criteria for 32 major HIV RCTs in the AIDS Clinical Trial Group (ACTG) and Community Programs for Clinical Research on AIDS (CPCRA) trial networks.Design and methods: Eligibility criteria were compared in complete protocols to criteria listed in publications from these 32 NIH-funded HIV RCTs. We then applied these criteria to the Women's Interagency HIV Study (WIHS), the largest cohort study of HIV-infected women in the US.Results: When applied to WIHS, eligibility criteria from protocols excluded 0-67.6% (median 42%) of WIHS participants (50.6% excluded from ACTG trials). Eligibility criteria in publications excluded 0-62% (median 19.6%) of WIHS (21.2% excluded from ACTC, trials). The number of women in WIHS seemingly ineligible for trial participation per enrollment criteria listed in publications averaged only 60% of those actually excluded based on the protocols.Conclusions: We found that HIV RCT eligibility criteria excluded a large proportion of a representative cohort of HIV-infected women from trial participation. Furthermore, trial publications are not fully reflective of protocols in terms of disclosing eligibility criteria. Standardization and full disclosure of trial methodology will allow clinicians and researchers to more fully assess the generalizability of findings to their patient populations. (c) 2005 Lippincott Williams & Wilkins.