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首页> 外文期刊>PLoS Medicine >A simplified, combined protocol versus standard treatment for acute malnutrition in children 6–59 months (ComPAS trial): A cluster-randomized controlled non-inferiority trial in Kenya and South Sudan
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A simplified, combined protocol versus standard treatment for acute malnutrition in children 6–59 months (ComPAS trial): A cluster-randomized controlled non-inferiority trial in Kenya and South Sudan

机译：6-59个月儿童急性营养不良（Compas试验）的简化，综合方案与标准治疗（Compas试验）：肯尼亚和南苏丹的集群随机控制的非劣级审判

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Background Malnutrition underlies 3 million child deaths worldwide. Current treatments differentiate severe acute malnutrition (SAM) from moderate acute malnutrition (MAM) with different products and programs. This differentiation is complex and costly. The Combined Protocol for Acute Malnutrition Study (ComPAS) assessed the effectiveness of a simplified, unified SAM/MAM protocol for children aged 6–59 months. Eliminating the need for separate products and protocols could improve the impact of programs by treating children more easily and cost-effectively, reaching more children globally. Methods and findings A cluster-randomized non-inferiority trial compared a combined protocol against standard care in Kenya and South Sudan. Randomization was stratified by country. Combined protocol clinics treated children using 2 sachets of ready-to-use therapeutic food (RUTF) per day for those with mid-upper arm circumference (MUAC) 11.5 cm and/or edema, and 1 sachet of RUTF per day for those with MUAC 11.5 to 12.5 cm. Standard care clinics treated SAM with weight-based RUTF rations, and MAM with ready-to-use supplementary food (RUSF). The primary outcome was nutritional recovery. Secondary outcomes included cost-effectiveness, coverage, defaulting, death, length of stay, and average daily weight and MUAC gains. Main analyses were per-protocol, with intention-to-treat analyses also conducted. The non-inferiority margin was 10%. From 8 May 2017 to 31 March 2018, 2,071 children were enrolled in 12 combined protocol clinics (mean age 17.4 months, 41% male), and 2,039 in 12 standard care clinics (mean age 16.7 months, 41% male). In total, 1,286 (62.1%) and 1,202 (59.0%), respectively, completed treatment; 981 (76.3%) on the combined protocol and 884 (73.5%) on the standard protocol recovered, yielding a risk difference of 0.03 (95% CI ?0.05 to 0.10, p = 0.52; per-protocol analysis, adjusted for country, age, and sex). The amount of ready-to-use food (RUTF or RUSF) required for a child with SAM to reach full recovery was less in the combined protocol (122 versus 193 sachets), and the combined protocol cost US$123 less per child recovered (US$918 versus US$1,041). There were 23 (1.8%) deaths in the combined protocol arm and 21 (1.8%) deaths in the standard protocol arm (adjusted risk difference 95% CI ?0.01 to 0.01, p = 0.87). There was no evidence of a difference between the protocols for any of the other secondary outcomes. Study limitations included contextual factors leading to defaulting, a combined multi-country power estimate, and operational constraints. Conclusions Combined treatment for SAM and MAM is non-inferior to standard care. Further research should focus on operational implications, cost-effectiveness, and context (Asia versus Africa; emergency versus food-secure settings). This trial is complete and registered at ISRCTN (ISRCTN30393230). Trial registration The trial is registered at ISRCTN, trial number ISRCTN30393230.
机译：背景营养不良是全世界300万儿童死亡。目前的治疗将严重的急性营养不良（SAM）与不同的产品和计划的中度急性营养不良（MAM）差异。这种差异是复杂且昂贵的。急性营养不良研究（COMPAS）的组合方案评估了6-59岁儿童的简化，统一的SAM / MAM议定书的有效性。消除对单独产品和协议的需求可以通过更容易和成本有效地治疗儿童，从而改善计划的影响，从全球范围内达到更多的儿童。方法和调查结果集群随机性非劣级审判与肯尼亚和南苏丹的标准护理组合协议进行了比较。随机化被国家分层。组合协议诊所治疗儿童每天使用2个即用途治疗食品（RUTF）的2个小袋，用于中上臂周长（MUAC）<11.5cm和/或水肿，每天1个rutf的rutf sachet MUAC 11.5至<12.5厘米。标准护理诊所用重量为基础的RUTF口粮处理SAM，以及随时使用的补充食物（RUSF）的MAM。主要结果是营养复苏。二次结果包括成本效益，覆盖率，违约，死亡，住宿时间和平均每日体重和MUAC收益。主要分析是每协定，也进行意向治疗分析。非劣势利润率为10％。从2017年5月8日至2018年3月31日，2,071名儿童注册了12项综合诊所（平均年龄为17.4个月，41％男性）和12,039名标准护理诊所（平均年龄为16.7个月，41％男性）。总共1,286（62.1％）和1,202（59.0％），完成治疗; 981（76.3％）在合并方案上和884（73.5％）回收的884（73.5％），产生0.03的风险差异（95％ci〜0.05至0.10，p = 0.52;每协定分析，调整为国家，年龄和性别）。萨姆儿童所需的即用食品（RUTF或RUSF）的数量在联合议定书中减少了（122名与193名Sachets），综合议定书每名儿童恢复较少的费用为123美元（美国） $ 918与1,041美元）。联合协议臂中有23例（1.8％）死亡，标准方案臂中的21例（1.8％）死亡（调整风险差95％CI〜0.01，P = 0.87）。没有证据表明任何其他次要结果的协议之间的差异。研究限制包括导致违约的上下文因素，组合的多国电力估计和运行约束。结论SAM和MAM的组合治疗是非较低的标准护理。进一步的研究应专注于运营影响，成本效益和背景（亚洲与非洲;紧急与食物安全设置）。此试验完成并在ISRCTN（ISRCTN30393230）中注册。试用登记该试验在ISRCTN，试验号ISRCTN30393230注册。

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