The identification and treatment of women with hyperglycaemia in pregnancy: an analysis of individual participant data, systematic reviews, meta-analyses and an economic evaluation
The identification and treatment of women with hyperglycaemia in pregnancy: an analysis of individual participant data, systematic reviews, meta-analyses and an economic evaluation
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DOI：
10.3310/hta20860
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发表时间：
2016-11-01
影响因子：
3.6
通讯作者：
Sheldon, Trevor A.
中科院分区：
文献类型：
--
作者：
Farrar, Diane;Simmonds, Mark;Sheldon, Trevor A.
背景：妊娠糖尿病（GDM）与重要不良结局的高风险相关。实践各不相同，最好的战略，以确定和治疗GDM是unclear.Aim：估计的临床效果和成本效益的战略，以确定和治疗妇女与GDM。方法：我们分析了个人参与者的数据（IPD）从出生队列和进行系统评价，以估计关联的母亲血糖水平与不良围产期结局; GDM患病率;母亲的特点/危险因素GDM;以及治疗的有效性和成本。各种战略的成本效益估计使用决策树模型，沿着的信息分析的价值，以评估未来的研究可能是值得的。详细系统检索MEDLINE（R）和MEDLINE过程中和其他非索引引文（R）、EMBASE、护理和相关健康文献累积索引Plus、科克伦对照试验中心注册库、科克伦系统综述数据库、疗效综述摘要数据库、卫生技术评估数据库、NHS经济评价数据库，母婴护理数据库和科克伦方法学登记从开始到2014年10月。结果：我们确定了58项研究，检查产妇血糖水平和结果的关联。单独使用IPD和系统回顾的分析表明，空腹和负荷后血糖水平与围产期不良结局之间存在持续线性相关性，没有明确的阈值，低于该阈值不会增加风险。使用IPD，我们估计了葡萄糖阈值，以识别出生时大于胎龄儿或高肥胖的高风险婴儿;对于南亚（SA）妇女，这些阈值分别为空腹和负荷后葡萄糖水平5.2 mmol/l和7.2 mmol/l，对于白色英国（WB）妇女，它们分别为5.4和7.5 mmol/l。使用IPD和已发表数据的患病率从1.2%到24.2%不等（取决于标准和人群），SA女性的患病率始终比WB女性高2 - 3倍。降低识别GDM的门槛，特别是在SA出身的妇女中，可以识别出更多处于风险中的妇女，但会增加成本。母亲的特征并不能准确地识别GDM妇女，有有限的证据表明，在某些人群中，风险因素可能有助于识别低风险妇女。除了常规护理外，饮食调整可降低大多数不良围产期结局的风险。二甲双胍（格华止，（R）Teva UK Ltd，伊斯特本，英国）和胰岛素比格列本脲（Aurobindo Pharma - Milpharm Ltd，South Ruislip，Middlesex，英国）更有效。对于所有识别和治疗GDM的策略，成本都超过了健康效益。无筛查/检测或治疗的政策提供了1184磅的最大预期净货币效益（NMB），成本效益阈值为每质量调整生命年（QALY）20，000磅。每个类别中三种表现最好的策略（仅筛选，然后治疗;筛选，测试，然后治疗;以及测试所有，然后治疗）的NMB范围在-1197磅和-1210磅之间。进一步的研究，以减少潜在的长期利益的母亲和后代周围的不确定性，找到提高识别GDM妇女的准确性的方法，并降低识别和治疗的成本将是值得的。限制：我们没有获得IPD从英国以外的英国人口。很少有观察性研究报告的长期协会，治疗试验一般只报告围产期outcome.Conclusions：使用国家标准的成本效益阈值为20,000磅每QALY它是不符合成本效益的常规识别孕妇治疗高血脂症。进一步的研究提供长期结果的证据，以及更经济有效的方法来检测和治疗GDM，将是有价值的。
Background: Gestational diabetes mellitus (GDM) is associated with a higher risk of important adverse outcomes. Practice varies and the best strategy for identifying and treating GDM is unclear.Aim: To estimate the clinical effectiveness and cost-effectiveness of strategies for identifying and treating women with GDM.Methods: We analysed individual participant data (IPD) from birth cohorts and conducted systematic reviews to estimate the association of maternal glucose levels with adverse perinatal outcomes; GDM prevalence; maternal characteristics/risk factors for GDM; and the effectiveness and costs of treatments. The cost-effectiveness of various strategies was estimated using a decision tree model, along with a value of information analysis to assess where future research might be worthwhile. Detailed systematic searches of MEDLINE (R) and MEDLINE In-Process & Other Non-Indexed Citations (R), EMBASE, Cumulative Index to Nursing and Allied Health Literature Plus, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Health Technology Assessment database, NHS Economic Evaluation Database, Maternity and Infant Care database and the Cochrane Methodology Register were undertaken from inception up to October 2014.Results: We identified 58 studies examining maternal glucose levels and outcome associations. Analyses using IPD alone and the systematic review demonstrated continuous linear associations of fasting and post-load glucose levels with adverse perinatal outcomes, with no clear threshold below which there is no increased risk. Using IPD, we estimated glucose thresholds to identify infants at high risk of being born large for gestational age or with high adiposity; for South Asian (SA) women these thresholds were fasting and post-load glucose levels of 5.2 mmol/l and 7.2 mmol/l, respectively and for white British (WB) women they were 5.4 and 7.5 mmol/l, respectively. Prevalence using IPD and published data varied from 1.2% to 24.2% (depending on criteria and population) and was consistently two to three times higher in SA women than in WB women. Lowering thresholds to identify GDM, particularly in women of SA origin, identifies more women at risk, but increases costs. Maternal characteristics did not accurately identify women with GDM; there was limited evidence that in some populations risk factors may be useful for identifying low-risk women. Dietary modification additional to routine care reduced the risk of most adverse perinatal outcomes. Metformin (Glucophage,(R) Teva UK Ltd, Eastbourne, UK) and insulin were more effective than glibenclamide (Aurobindo Pharma - Milpharm Ltd, South Ruislip, Middlesex, UK). For all strategies to identify and treat GDM, the costs exceeded the health benefits. A policy of no screening/testing or treatment offered the maximum expected net monetary benefit (NMB) of 1184 pound at a cost-effectiveness threshold of 20,000 pound per quality-adjusted life-year (QALY). The NMB for the three best-performing strategies in each category (screen only, then treat; screen, test, then treat; and test all, then treat) ranged between -1197 pound and -1210 pound. Further research to reduce uncertainty around potential longer-term benefits for the mothers and offspring, find ways of improving the accuracy of identifying women with GDM, and reduce costs of identification and treatment would be worthwhile.Limitations: We did not have access to IPD from populations in the UK outside of England. Few observational studies reported longer-term associations, and treatment trials have generally reported only perinatal outcomes.Conclusions: Using the national standard cost-effectiveness threshold of 20,000 pound per QALY it is not cost-effective to routinely identify pregnant women for treatment of hyperglycaemia. Further research to provide evidence on longer-term outcomes, and more cost-effective ways to detect and treat GDM, would be valuable.