Baldwin Christine, Kimber Katherine L, Gibbs Michelle, Weekes Christine Elizabeth
Diabetes & Nutritional Sciences Division, School of Medicine, King's College London, Franklin Wilkins Building, 150 Stamford Street, London, UK, SE1 9NH.
Diabetes & Nutritional Sciences Division, School of Medicine, King's College London, Franklin Wilkin's Building, Stamford Street, London, UK, SE1 9NH.
Cochrane Database Syst Rev. 2016 Dec 20;12(12):CD009840. doi: 10.1002/14651858.CD009840.pub2.
Supportive interventions such as serving meals in a dining room environment or the use of assistants to feed patients are frequently recommended for the management of nutritionally vulnerable groups. Such interventions are included in many policy and guideline documents and have implications for staff time but may incur additional costs, yet there appears to be a lack of evidence for their efficacy.
To assess the effects of supportive interventions for enhancing dietary intake in malnourished or nutritionally at-risk adults.
We identified publications from comprehensive searches of the Cochrane Library, MEDLINE, Embase, AMED, British Nursing Index, CINAHL, SCOPUS, ISI Web of Science databases, scrutiny of the reference lists of included trials and related systematic reviews and handsearching the abstracts of relevant meetings. The date of the last search for all databases was 31 March 2013. Additional searches of CENTRAL, MEDLINE, ClinicalTrials.gov and WHO ICTRP were undertaken to September 2016. The date of the last search for these databases was 14 September 2016.
Randomised controlled trials of supportive interventions given with the aim of enhancing dietary intake in nutritionally vulnerable adults compared with usual care.
Three review authors and for the final search, the editor, selected trials from titles and abstracts and independently assessed eligibility of selected trials. Two review authors independently extracted data and assessed risk of bias, as well as evaluating overall quality of the evidence utilising the GRADE instrument, and then agreed as they entered data into the review. The likelihood of clinical heterogeneity amongst trials was judged to be high as trials were in populations with widely different clinical backgrounds, conducted in different healthcare settings and despite some grouping of similar interventions, involved interventions that varied considerably. We were only able, therefore, to conduct meta-analyses for the outcome measures, 'all-cause mortality', 'hospitalisation' and 'nutritional status (weight change)'.
Forty-one trials (10,681 participants) met the inclusion criteria. Trials were grouped according to similar interventions (changes to organisation of nutritional care (N = 13; 3456 participants), changes to the feeding environment (N = 5; 351 participants), modification of meal profile or pattern (N = 12; 649 participants), additional supplementation of meals (N = 10; 6022 participants) and home meal delivery systems (N = 1; 203 participants). Follow-up ranged from 'duration of hospital stay' to 12 months.The overall quality of evidence was moderate to very low, with the majority of trials judged to be at an unclear risk of bias in several risk of bias domains. The risk ratio (RR) for all-cause mortality was 0.78 (95% confidence interval (CI) 0.66 to 0.92); P = 0.004; 12 trials; 6683 participants; moderate-quality evidence. This translates into 26 (95% CI 9 to 41) fewer cases of death per 1000 participants in favour of supportive interventions. The RR for number of participants with any medical complication ranged from 1.42 in favour of control compared with 0.59 in favour of supportive interventions (very low-quality evidence). Only five trials (4451 participants) investigated health-related quality of life showing no substantial differences between intervention and comparator groups. Information on patient satisfaction was unreliable. The effects of supportive interventions versus comparators on hospitalisation showed a mean difference (MD) of -0.5 days (95% CI -2.6 to 1.6); P = 0.65; 5 trials; 667 participants; very low-quality evidence. Only three of 41 included trials (4108 participants; very low-quality evidence) reported on adverse events, describing intolerance to the supplement (diarrhoea, vomiting; 5/34 participants) and discontinuation of oral nutritional supplements because of refusal or dislike of taste (567/2017 participants). Meta-analysis across 17 trials with adequate data on weight change revealed an overall improvement in weight in favour of supportive interventions versus control: MD 0.6 kg (95% CI 0.21 to 1.02); 2024 participants; moderate-quality evidence. A total of 27 trials investigated nutritional intake with a majority of trials not finding marked differences in energy intake between intervention and comparator groups. Only three trials (1152 participants) reported some data on economic costs but did not use accepted health economic methods (very low-quality evidence).
AUTHORS' CONCLUSIONS: There is evidence of moderate to very low quality to suggest that supportive interventions to improve nutritional care results in minimal weight gain. Most of the evidence for the lower risk of all-cause mortality for supportive interventions comes from hospital-based trials and more research is needed to confirm this effect. There is very low-quality evidence regarding adverse effects; therefore whilst some of these interventions are advocated at a national level clinicians should recognise the lack of clear evidence to support their role. This review highlights the importance of assessing patient-important outcomes in future research.
对于营养脆弱群体的管理，经常推荐一些支持性干预措施，如在餐厅环境中提供膳食或使用助手为患者喂食。此类干预措施包含在许多政策和指南文件中，这对工作人员的时间安排有影响，而且可能会产生额外费用，但似乎缺乏其有效性的证据。
评估支持性干预措施对改善营养不良或有营养风险的成年人饮食摄入量的效果。
我们通过全面检索Cochrane图书馆、MEDLINE、Embase、AMED、英国护理索引、CINAHL、SCOPUS、ISI科学网数据库，仔细审查纳入试验的参考文献列表及相关系统评价，并手工检索相关会议的摘要来识别出版物。所有数据库的最后检索日期为2013年3月31日。对CENTRAL、MEDLINE、ClinicalTrials.gov和WHO ICTRP进行了额外检索，直至2016年9月。这些数据库的最后检索日期为2016年9月14日。
与常规护理相比，旨在提高营养脆弱成年人饮食摄入量的支持性干预措施的随机对照试验。
三位综述作者以及最终检索时的编辑，从标题和摘要中选择试验，并独立评估所选试验的合格性。两位综述作者独立提取数据并评估偏倚风险，以及使用GRADE工具评估证据的整体质量，然后在录入数据进行综述时达成一致。由于试验针对的是临床背景差异很大的人群，在不同的医疗环境中进行，并且尽管对相似干预措施进行了一些分组，但所涉及的干预措施差异很大，因此判断试验之间临床异质性的可能性很高。因此，我们仅能对“全因死亡率”、“住院治疗”和“营养状况（体重变化）”这些结局指标进行荟萃分析。
41项试验（10681名参与者）符合纳入标准。试验根据相似干预措施进行分组（营养护理组织的改变（N = 13；3456名参与者）、喂食环境的改变（N = 5；351名参与者）、膳食特征或模式的改变（N = 12；649名参与者）、膳食额外补充（N = 10；6022名参与者）以及家庭送餐系统（N = 1；203名参与者））。随访时间从“住院时间”到12个月不等。证据的整体质量为中等至非常低，大多数试验在几个偏倚风险领域被判定为偏倚风险不明确。全因死亡率的风险比（RR）为0.78（95%置信区间（CI）0.66至0.92）；P = 0.004；12项试验；6683名参与者；中等质量证据。这意味着每1000名参与者中，支持性干预措施组的死亡病例减少26例（95%CI 9至41）。有任何医疗并发症的参与者数量的RR范围为支持对照组的1.42至支持支持性干预措施组的0.59（极低质量证据）。只有五项试验（4451名参与者）调查了与健康相关的生活质量，显示干预组和对照组之间没有实质性差异。关于患者满意度的信息不可靠。支持性干预措施与对照措施对住院治疗的影响显示平均差（MD）为 -0.5天（95%CI -2.6至1.6）；P = 0.65；5项试验；667名参与者；极低质量证据。41项纳入试验中只有三项（4108名参与者；极低质量证据）报告了不良事件，描述了对补充剂不耐受（腹泻、呕吐；5/34名参与者）以及因拒绝或不喜欢味道而停止口服营养补充剂（567/2017名参与者）。对17项有足够体重变化数据的试验进行的荟萃分析显示，与对照组相比，支持性干预措施组的体重总体有所改善：MD 0.6千克（95%CI 0.21至1.02）；2024名参与者；中等质量证据。共有27项试验调查了营养摄入量，大多数试验未发现干预组和对照组之间的能量摄入量有明显差异。只有三项试验（1152名参与者）报告了一些关于经济成本的数据，但未使用公认的卫生经济方法（极低质量证据）。
有中等至非常低质量的证据表明，改善营养护理的支持性干预措施导致体重略有增加。支持性干预措施全因死亡率较低的大部分证据来自基于医院的试验，需要更多研究来证实这一效果。关于不良反应的证据质量非常低；因此，尽管其中一些干预措施在国家层面得到倡导，但临床医生应认识到缺乏明确证据支持其作用。本综述强调了在未来研究中评估对患者重要的结局指标的重要性。
