NIH consensus development conference: diagnosing gestational diabetes mellitus.

James P Vandorsten, William C Dodson, Mark A Espeland, William A Grobman, Jeanne Marie Guise, Brian M Mercer, Howard L Minkoff, Brenda Poindexter, Lisa A Prosser, George F Sawaya, James R Scott, Robert M Silver, Lisa Smith, Alyce Thomas, Alan T N Tita
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Abstract

Objective: To provide healthcare providers, patients, and the general public with a responsible assessment of currently available data on diagnosing gestational diabetes mellitus (GDM).

Participants: A non-U.S. Department of Health and Human Services, nonadvocate 15-member panel representing the fields of obstetrics and gynecology, maternal-fetal medicine, pediatrics, diabetic research, biostatistics, women's health issues, health services research, decision analysis, health management and policy, health economics, epidemiology, and community engagement. In addition, 16 experts from pertinent fields presented data to the panel and conference audience.

Evidence: Presentations by experts and a systematic review of the literature prepared by the University of Alberta Evidence-based Practice Centre, through the Agency for Healthcare Research and Quality (AHRQ). Scientific evidence was given precedence over anecdotal experience.

Conference process: The panel drafted its statement based on scientific evidence presented in open forum and on published scientific literature. The draft statement was posted at http://prevention.nih.gov/ for public comment and the panel released a final statement approximately 10 weeks later. The final statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government.

Conclusions: At present, GDM is commonly diagnosed in the United States using a 1-hour screening test with a 50-gram glucose load followed by a 3-hour 100-gram glucose tolerance test (a two-step approach) for those found to be abnormal on the screen. This approach identifies approximately 5% to 6% of the population as having GDM. In contrast, newly proposed diagnostic strategies rely on the administration of a 2-hour glucose tolerance test (a one-step approach) with a fasting component and a 75-gram glucose load. These strategies differ on whether a 1-hour sample is included, whether two abnormal values are required, and the diagnostic cutoffs that are used. The International Association of Diabetes and Pregnancy Study Groups (IADPSG) has proposed diagnostic thresholds based on demonstrated associations between glycemic levels and an increased risk of obstetric and perinatal morbidities. The panel considered whether a one-step approach to the diagnosis of GDM should be adopted in place of the two-step approach. The one-step approach offers certain operational advantages. The current two-step approach is used only during pregnancy and is largely restricted to the United States. There would be value in a consistent, international diagnostic standard across one's lifespan. This unification would allow better standardization of best practices in patient care and comparability of research outcomes. The one-step approach also holds potential advantages for women and their health care providers, as it would allow a diagnosis to be achieved within the context of one visit as opposed to two. However, the one-step approach, as proposed by the IADPSG, is anticipated to increase the frequency of the diagnosis of GDM by twofold to threefold, to a prevalence of approximately 15% to 20%. There are several concerns regarding the diagnosis of GDM in these additional women. It is not well understood whether the additional women identified by this approach will benefit from treatment, and if so, to what extent. Moreover, the care of these women will generate additional direct and indirect health care costs. There is also evidence that the labeling of these women may have unintended consequences, such as an increase in cesarean delivery and more intensive newborn assessments. In addition, increased patient costs, life disruptions, and psychosocial burdens have been identified. Available studies do not provide clear evidence that a one-step approach is cost-effective in comparison with the current two-step approach. After much deliberation, the panel believes that there are clear benefits to international standardization with regard to the one-step approach. Nevertheless, at present, the panel believes that there is not sufficient evidence to adopt a one-step approach. The panel is particularly concerned about the adoption of new criteria that would increase the prevalence of GDM, and the corresponding costs and interventions, without clear demonstration of improvements in the most clinically important health and patient-centered outcomes. Thus, the panel recommends that the two-step approach be continued. However, given the potential benefits of a one-step approach, resolution of the uncertainties associated with its use would warrant revision of this conclusion.

美国国立卫生研究院共识发展会议:诊断妊娠糖尿病。
目的:为医疗保健提供者、患者和公众提供对妊娠期糖尿病(GDM)诊断现有数据的负责任的评估。参与者:非美国人。美国卫生与公众服务部,由15人组成的非倡导者小组,代表妇产科、母胎医学、儿科、糖尿病研究、生物统计学、妇女健康问题、卫生服务研究、决策分析、卫生管理和政策、卫生经济学、流行病学和社区参与等领域。此外,来自相关领域的16位专家向小组和会议听众介绍了数据。证据:专家的介绍和阿尔伯塔大学循证实践中心通过卫生保健研究和质量局(AHRQ)编写的文献系统审查。科学证据优先于轶事经验。会议进程:小组根据公开论坛上提出的科学证据和已发表的科学文献起草了声明。该声明草案已在http://prevention.nih.gov/网站上公布,征求公众意见。大约10周后,专家组发布了一份最终声明。最终声明是专家组的一份独立报告,不是NIH或联邦政府的政策声明。结论:目前,在美国,GDM的诊断通常采用1小时50克葡萄糖负荷筛查试验,然后对筛查结果异常的患者进行3小时100克葡萄糖耐量试验(两步法)。这种方法确定了大约5%到6%的人口患有GDM。相比之下,新提出的诊断策略依赖于2小时葡萄糖耐量试验(一步法),其中包括禁食成分和75克葡萄糖负荷。这些策略的不同之处在于是否包括一个1小时的样本,是否需要两个异常值,以及使用的诊断截止点。国际糖尿病和妊娠研究小组协会(IADPSG)根据已证实的血糖水平与产科和围产期疾病风险增加之间的关联,提出了诊断阈值。专家组考虑是否应采用一步法诊断GDM,以取代两步法。一步法提供了一定的操作优势。目前的两步方法仅在怀孕期间使用,并且在很大程度上仅限于美国。在一个人的一生中,一个一致的国际诊断标准将是有价值的。这种统一将使患者护理的最佳实践更好地标准化,并使研究结果具有可比性。一步法对妇女及其保健提供者也有潜在的优势,因为它可以在一次就诊而不是两次就诊的情况下做出诊断。然而,按照IADPSG的建议,一步法预计将使GDM的诊断频率增加两到三倍,患病率约为15%至20%。在这些额外的女性中,有几个关于GDM诊断的问题。目前尚不清楚通过这种方法确定的额外妇女是否会从治疗中受益,如果受益,会在多大程度上受益。此外,照顾这些妇女将产生额外的直接和间接保健费用。也有证据表明,给这些妇女贴上标签可能会产生意想不到的后果,例如剖腹产的增加和更密集的新生儿评估。此外,还发现了患者费用增加、生活中断和社会心理负担。现有的研究没有提供明确的证据表明一步法比目前的两步法更具成本效益。经过深思熟虑后,专家组认为,就一步法而言,国际标准化有明显的好处。然而,目前,专家小组认为没有足够的证据采取一步办法。专家组特别关注的是,采用新标准将增加GDM的流行率,以及相应的成本和干预措施,而没有明确证明在临床上最重要的健康和以患者为中心的结果方面有改善。因此,小组建议继续采取两步办法。但是,考虑到一步法的潜在好处,解决与使用该方法有关的不确定因素需要对这一结论进行修订。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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