Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.
J Nutr. 2012 Jan;142(1):205S-9S. doi: 10.3945/jn.110.137158. Epub 2011 Nov 23.
Evidence for the efficacy of multiple micronutrient (MMN) supplementation has been established by state-of-the-art randomized controlled trials (RCT). These efficacy trials have also provided strong evidence of the widespread occurrence of deficiencies. Trials intended to demonstrate a public health benefit must show that the magnitude of benefit is adequate for policy considerations. In the MMN efficacy studies the magnitude of impact was generally inadequate. The extent to which this was due to various factors that affect individuals' potential to respond to MMN supplementation has not been examined, and trials have not been designed to provide insights into why impact is below expectation. For instance, when birth weight was the outcome of concern, impact was not related to presumed need, judged by baseline birth-weight values. Also, contrary to expectations, the impacts were greater among the heavier mothers. Our inability to examine issues of adequacy, plausibility, and implementation with efficacy trial approaches as they are currently conducted, calls into question the present standards for designing and interpreting community RCT in nutrition. Improving the capacity of efficacy studies to yield more meaningful data requires a number of modifications to current practices, such as including measures of the intermediary behavioral and biological steps between intervention and biological outcomes to assess the adequacy and plausibility of the findings. The progression from RCT to program interventions must also extend research to program delivery and uptake to ascertain the full program impact pathway. This in turn requires novel organizations of relationships between research and program development and implementation.
多种微量营养素(MMN)补充的疗效已通过最先进的随机对照试验(RCT)得到证实。这些疗效试验也为广泛存在的营养缺乏提供了强有力的证据。旨在证明公共卫生效益的试验必须表明效益的幅度足以满足政策考虑。在 MMN 疗效研究中,影响的幅度通常不足。尚未研究导致个体对 MMN 补充反应潜力的各种因素在多大程度上导致了这一情况,而且试验的设计也没有提供关于为什么影响低于预期的见解。例如,当出生体重是关注的结果时,影响与根据基线出生体重值判断的假定需求无关。此外,与预期相反,体重较大的母亲的影响更大。由于目前进行的疗效试验方法无法检查充分性、合理性和实施问题,因此对目前设计和解释营养社区 RCT 的标准提出了质疑。要提高疗效研究产生更有意义数据的能力,需要对当前做法进行一些修改,例如纳入干预和生物学结果之间的中介行为和生物学步骤的衡量标准,以评估研究结果的充分性和合理性。从 RCT 到方案干预的进展还必须将研究扩展到方案的实施和采用,以确定方案的全面影响途径。这反过来又需要在研究和方案制定与实施之间建立新的关系组织。