N-of-1 trials in the clinical care of patients in developing countries: a systematic review.
N-of-1 trials in the clinical care of patients in developing countries: a systematic review.
复制标题
DOI：
10.1186/s13063-018-2596-5
复制
发表时间：
2018-04-23
期刊：
影响因子：
2.5
通讯作者：
Mitchell G
中科院分区：
文献类型：
--
作者：
Alemayehu C;Nikles J;Mitchell G
N-of-1试验在促进发展中国家以患者为中心的医学方面具有潜在的作用。然而，关于在资源匮乏的环境中使用N-of-1试验进行临床护理的学术文献有限。评估N-of-1试验在发展中国家的使用范围、目的和治疗结果。1985年至2015年9月期间，使用PubMed、Embase、CINAHL、Web of Science和Cochrane Central Register of Control Trials对N-of-1临床试验进行了系统回顾。还搜索了灰色文献数据库和临床试验登记。这篇综述包括随机、多周期、交叉的涉及药物干预的个体患者试验。质量评估和数据提取由两名独立的审查员进行。在确定的131项N-of-1试验中，只有6项(4.5%)是在发展中国家进行的。使用N-of-1试验的主要原因是为治疗的可行性、有效性和安全性提供证据。共有72名参与者参与了这些试验。其中五项研究是在中国进行的，所有研究都对中医药进行了评估。其余研究是在巴西进行的。完成率为93%。超过一半，46(69%)的受试者在试验完成后进行了与试验结果一致的药物改变。对所包括证据的有效性的一些威胁限制了证据的有效性。特别是，在纳入的四项研究中，由于没有提出关于传统药物的充分药代动力学证据，估计的总体效果可能受到先前治疗效果的“遗留”的影响。N-of-1试验在发展中国家的流行率和范围都很低。需要政府、临床医生、研究人员和赞助组织之间的协调努力，以提高它们在发展中国家的摄入量和质量。PROSPERO CRD42015026841。本文的在线版本(10.1186/s13063-0182596-5)包含补充材料，可供授权用户使用。
N-of-1 trials have a potential role in promoting patient-centered medicine in developing countries. However, there is limited academic literature regarding the use of N-of-1 trials in the clinical care of patients in resource-poor settings. To assess the extent of use, purpose and treatment outcome of N-of-1 trials in developing countries. A systematic review of clinical N-of-1 trials was conducted between 1985 and September 2015 using PubMed, Embase, CINAHL, Web of Science and the Cochrane Central Register of Controlled Trials. Grey literature databases and clinical trial registers were also searched. This review included randomized, multi-cycle, crossover within individual patient trials involving drug intervention. Quality assessment and data extraction were conducted by two independent reviewers. Out of 131 N-of-1 trials identified, only 6 (4.5%) were conducted in developing countries. The major reason that N-of-1 trials were used was to provide evidence on feasibility, effectiveness and safety of therapies. A total of 72 participants were involved in these trials. Five of the studies were conducted in China and all evaluated Chinese traditional medicine. The remaining study was conducted in Brazil. The completion rate was 93%. More than half, 46 (69%) of subjects made medication changes consistent with trial results after trial completion. A number of threats to the validity of the included evidence limited the validity of the evidence. In particular, the estimated overall effect in four of the included studies could have been affected by the “carry over” of the previous treatment effect as no adequate pharmacokinetic evidence regarding traditional medicines was presented. The prevalence and scope of N-of-1 trials in developing countries is low. A coordinated effort among government, clinicians, researchers and sponsor organizations is needed to increase their uptake and quality in developing countries. PROSPERO CRD42015026841. The online version of this article (10.1186/s13063-018-2596-5) contains supplementary material, which is available to authorized users.
登录
查看更多内容
影响因子：
158.5
作者：
GUYATT, G;SACKETT, D;PUGSLEY, S
通讯作者：
PUGSLEY, S
影响因子：
4.5
作者：
Cameron, Christopher G.;Synnott, Patricia G.;Ollendorf, Daniel A.
通讯作者：
Ollendorf, Daniel A.
影响因子：
7.2
作者：
Duan, Naihua;Kravitz, Richard L.;Schmid, Christopher H.
通讯作者：
Schmid, Christopher H.
影响因子：
1.1
作者：
Chow, Shein-Chung;Song, Fuyu;Cui, Can
通讯作者：
Cui, Can
影响因子：
4.2
作者：
Currie, Graeme P.;Lee, Daniel K. C.;Lipworth, Brian J.
通讯作者：
Lipworth, Brian J.