Informed consent rates for neonatal randomized controlled trials in low- and lower middle-income versus high-income countries: A systematic review.
Informed consent rates for neonatal randomized controlled trials in low- and lower middle-income versus high-income countries: A systematic review.
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DOI：
10.1371/journal.pone.0248263
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发表时间：
2021
期刊：
影响因子：
3.7
通讯作者：
Thayyil S
中科院分区：
文献类型：
--
作者：
Patterson JK;Pant S;Jones DF;Taha S;Jones MS;Bauserman MS;Montaldo P;Bose CL;Thayyil S
医学研究的法律的、伦理的和管理的要求一致要求知情同意。我们旨在描述和比较低收入和中低收入国家与高收入国家新生儿随机对照试验的同意率，并评估研究特征对同意率的影响。在本系统性综述中，我们检索了MEDLINE、EMBASE和科克伦，以查找2013年1月1日至2018年1月4日发表的低收入和中低收入国家或高收入国家新生儿干预的随机对照试验。我们的主要结果是同意率，即从文章或与作者的电子邮件中提取的合格参与者中同意的比例。使用分数因变量的广义线性模型，我们分析了低收入和中低收入国家与高收入国家在控制类型和干预措施方面的知情同意几率。我们筛选了3523篇文章，产生了300项合格的随机对照试验，其中135项低收入和中低收入国家试验和65项高收入国家试验的同意率可用。低收入和中低收入国家的中位同意率（95.6%;四分位距（IQR）88.2-98.9）高于高收入国家（82.7%; IQR 68.6-93.0; p<0.001）。在对低收入和中低收入国家与高收入国家进行比较的调整回归分析中，无安慰剂药物/营养试验的同意几率为3.67（95%置信区间（CI）1.87-7.19; p = 0.0002），安慰剂药物/营养试验的同意几率为6.40（95%CI 3.32-12.34; p<0.0001）。低收入和中低收入国家的新生儿随机对照试验报告的同意率始终高于高收入国家试验。我们的研究受到印度在低收入和中低收入国家随机对照试验中的过度代表性的限制。这项研究对低收入和中低收入国家招募参加临床试验的高度脆弱人群的保护是否充分提出了严重关切。
Legal, ethical, and regulatory requirements of medical research uniformly call for informed consent. We aimed to characterize and compare consent rates for neonatal randomized controlled trials in low- and lower middle-income countries versus high-income countries, and to evaluate the influence of study characteristics on consent rates. In this systematic review, we searched MEDLINE, EMBASE and Cochrane for randomized controlled trials of neonatal interventions in low- and lower middle-income countries or high-income countries published 01/01/2013 to 01/04/2018. Our primary outcome was consent rate, the proportion of eligible participants who consented amongst those approached, extracted from the article or email with the author. Using a generalised linear model for fractional dependent variables, we analysed the odds of consenting in low- and lower middle-income countries versus high-income countries across control types and interventions. We screened 3523 articles, yielding 300 eligible randomized controlled trials with consent rates available for 135 low- and lower middle-income country trials and 65 high-income country trials. Median consent rates were higher for low- and lower middle-income countries (95.6%; interquartile range (IQR) 88.2–98.9) than high-income countries (82.7%; IQR 68.6–93.0; p<0.001). In adjusted regression analysis comparing low- and lower middle-income countries to high-income countries, the odds of consent for no placebo-drug/nutrition trials was 3.67 (95% Confidence Interval (CI) 1.87–7.19; p = 0.0002) and 6.40 (95%CI 3.32–12.34; p<0.0001) for placebo-drug/nutrition trials. Neonatal randomized controlled trials in low- and lower middle-income countries report consistently higher consent rates compared to high-income country trials. Our study is limited by the overrepresentation of India among randomized controlled trials in low- and lower middle-income countries. This study raises serious concerns about the adequacy of protections for highly vulnerable populations recruited to clinical trials in low- and lower middle-income countries.
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影响因子：
15.8
作者：
Henderson GE;Churchill LR;Davis AM;Easter MM;Grady C;Joffe S;Kass N;King NM;Lidz CW;Miller FG;Nelson DK;Peppercorn J;Rothschild BB;Sankar P;Wilfond BS;Zimmer CR
通讯作者：
Zimmer CR
影响因子：
12.7
作者：
Karim, QA;Karim, SSA;Susser, M
通讯作者：
Susser, M
DOI：
10.1136/adc.2004.065078
发表时间：
2005-05-01
影响因子：
4.4
作者：
Hoehn, KS;Wernovsky, G;Nelson, RM
通讯作者：
Nelson, RM
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作者：
Kongsholm, Nana Cecilie Halmsted;Lassen, Jesper;Sandoe, Peter
通讯作者：
Sandoe, Peter
影响因子：
2.9
作者：
Chappuy, Helene;Bouazza, Naim;Doz, Francois
通讯作者：
Doz, Francois