Stow Ruth, Ives Natalie, Smith Christina, Rick Caroline, Rushton Alison
Health Research MRes, University of Birmingham, School of Sport, Exercise and Rehabilitation Sciences, Edgbaston, Birmingham, B15 2TT, UK.
The University of Nottingham, School of Biosciences, Division of Nutritional Sciences, Sutton Bonington campus, Nottingham, LE12 5RD, UK.
Trials. 2015 Sep 28;16:433. doi: 10.1186/s13063-015-0952-2.
Protein energy malnutrition (PEM) predisposes individuals to disease, delays recovery from illness and reduces quality of life. Care home residents in the United Kingdom are especially vulnerable, with an estimated 30 to 42 % at risk. Evidence for nutritional interventions to address PEM in the care home setting is lacking. Widely used techniques include food-based intervention and/or the use of prescribed oral nutritional supplements. To define outcomes and optimise the design for an adequately powered definitive trial to compare the efficacy of established nutritional interventions in this setting, a cluster randomised feasibility trial with a 6-month intervention was undertaken.
Care home residents with or at risk of malnutrition were identified across six UK care home sites from September to December 2013. Homes were cluster randomised to standard care (SC), food-based intervention (FB) or oral nutritional supplement intervention (ONS), for 6 months. Key outcomes were trial feasibility and the acceptability of design, allocated interventions and outcome assessments. Anthropometry, dietary intake, healthcare resource usage and participant-reported outcome measures were assessed at baseline and at 3 and 6 months.
All six care homes approached were recruited and retained. Of the 110 residents at risk of malnutrition, 85 % entered the trial, and 68 % completed the 6-month intervention. Pre-specified success criteria for feasibility were met for recruitment and retention, intervention acceptability (resident compliance ≥60 %) and measurement of weight, body mass index (BMI), mid-upper arm circumference and dietary intake (data completeness >80 %). Measurement of handgrip strength and triceps skinfold thickness was not found to be feasible in this population. The 95 % confidence interval (CI) data suggested sensitivity to change in dietary intake for weight, BMI and energy intake between baseline and 3 months when each intervention (FB and ONS) was compared with SC.
A definitive trial comparing the efficacy of nutritional support interventions in increasing weight and BMI in malnourished care home residents can be conducted. However, whilst the design was feasible, this trial has highlighted the lack of clinically and patient-relevant outcome measures that are appropriate for use in this setting for both research and clinical practice. In particular, this trial identified a need for a more simple measure of functional status, which considers the limitations of functional tests in the care home population.
Current Controlled Trials ISRCTN38047922 , Date assigned: 22 April 2014.
蛋白质能量营养不良（PEM）使个体易患疾病，延缓疾病康复并降低生活质量。英国养老院居民尤其脆弱，估计有30%至42%的人面临风险。缺乏针对养老院环境中解决PEM的营养干预措施的证据。广泛使用的技术包括基于食物的干预和/或使用处方口服营养补充剂。为了确定结局并优化一项有足够效力的确定性试验的设计，以比较既定营养干预措施在此环境中的疗效，进行了一项为期6个月干预的整群随机可行性试验。
2013年9月至12月，在英国六个养老院地点识别出患有营养不良或有营养不良风险的居民。各养老院被整群随机分为接受标准护理（SC）、基于食物的干预（FB）或口服营养补充剂干预（ONS），为期6个月。关键结局是试验可行性以及设计、分配的干预措施和结局评估的可接受性。在基线以及3个月和6个月时评估人体测量学、饮食摄入量、医疗资源使用情况和参与者报告的结局指标。
所有六个被联系的养老院均被招募并保留。在110名有营养不良风险的居民中，85%进入试验，68%完成了6个月的干预。在招募和保留、干预可接受性（居民依从性≥60%）以及体重、体重指数（BMI）、上臂中部周长和饮食摄入量的测量（数据完整性>80%）方面，达到了预先设定的可行性成功标准。在该人群中，未发现测量握力和三头肌皮褶厚度是可行的。95%置信区间（CI）数据表明，将每种干预措施（FB和ONS）与SC进行比较时，在基线至3个月期间，体重、BMI和能量摄入量对饮食摄入量变化的敏感性。
可以进行一项确定性试验，比较营养支持干预措施在增加营养不良养老院居民体重和BMI方面的疗效。然而，虽然该设计是可行的，但该试验凸显了缺乏适用于此环境用于研究和临床实践的临床和患者相关结局指标。特别是，该试验确定需要一种更简单的功能状态测量方法，该方法考虑到养老院人群中功能测试的局限性。
Current Controlled Trials ISRCTN38047922，分配日期：2014年4月22日。
