The need for pragmatic clinical trials in low and middle income settings - taking essential neonatal interventions delivered as part of inpatient care as an illustrative example
The need for pragmatic clinical trials in low and middle income settings - taking essential neonatal interventions delivered as part of inpatient care as an illustrative example
复制标题
DOI：
10.1186/s12916-016-0556-z
复制
发表时间：
2016-01-18
期刊：
影响因子：
9.3
通讯作者：
Opiyo, Newton
中科院分区：
文献类型：
--
作者：
English, Mike;Karumbi, Jamlick;Opiyo, Newton
背景资料：实用的随机试验旨在检查干预措施对接受常规护理的临床医生所见的全方位患者的影响。在进行这些试验的同时，还应努力实施许多看来有希望但有效性证据有限的干预措施。我们说明了这一需要采取必要的干预措施，以减少住院新生儿死亡率在低收入和中等收入国家（LMIC）的情况下，但建议的参数是适用于大多数临床areas.Discussion：一组基本的干预措施已被定义，根据现有的证据，可以大大减少早期新生儿死亡，如果成功地实施在大规模内区和分区医院在LMIC。然而，我们表明，在现有的证据中仍然存在许多差距，以指导许多住院新生儿干预措施的实施，现有的证据往往来自高收入环境，它经常表明效果估计的幅度甚至方向的不确定性。此外，将结果推广到LMIC，其中条件包括非常高的患者工作人员比例，甚至缺乏基本技术，以及依赖于主要的经验管理是有问题的。如果有这样的不确定性的干预措施的有效性在不同的情况下，或在广泛的人群谁可能会收到干预措施在常规护理设置务实的试验，保持内部的有效性，同时促进外部validityshould be increasingly employed.Summary：许多干预措施的介绍没有足够的证据表明其有效性在常规设置，他们被引入。需要全球努力支持务实的研究，以确定旨在降低低收入国家死亡率或发病率的许多干预措施在常规护理中的有效性。这种研究应被视为对优化执行工作的补充。
Background: Pragmatic randomized trials aim to examine the effects of interventions in the full spectrum of patients seen by clinicians who receive routine care. Such trials should be employed in parallel with efforts to implement many interventions which appear promising but where evidence of effectiveness is limited. We illustrate this need taking the case of essential interventions to reduce inpatient neonatal mortality in low and middle income countries (LMIC) but suggest the arguments are applicable in most clinical areas.Discussion: A set of basic interventions have been defined, based on available evidence, that could substantially reduce early neonatal deaths if successfully implemented at scale within district and sub-district hospitals in LMIC. However, we illustrate that there remain many gaps in the evidence available to guide delivery of many inpatient neonatal interventions, that existing evidence is often from high income settings and that it frequently indicates uncertainty in the magnitude or even direction of estimates of effect. Furthermore generalizing results to LMIC where conditions include very high patient staff ratios, absence of even basic technologies, and a reliance on largely empiric management is problematic. Where there is such uncertainty over the effectiveness of interventions in different contexts or in the broad populations who might receive the intervention in routine care settings pragmatic trials that preserve internal validity while promoting external validity should be increasingly employed.Summary: Many interventions are introduced without adequate evidence of their effectiveness in the routine settings to which they are introduced. Global efforts are needed to support pragmatic research to establish the effectiveness in routine care of many interventions intended to reduce mortality or morbidity in LMIC. Such research should be seen as complementary to efforts to optimize implementation.