University of Connecticut, Farmington, Connecticut, USA.
J Allergy Clin Immunol. 2012 Mar;129(3 Suppl):S24-33. doi: 10.1016/j.jaci.2011.12.980.
Current asthma guidelines recommend assessing the level of a patient's asthma control. Consequently, there is increasing use of asthma control as an outcome measure in clinical research studies. Several composite assessment instruments have been developed to measure asthma control.
National Institutes of Health institutes and federal agencies convened an expert group to propose the most appropriate standardized composite score of asthma control instruments to be used in future asthma studies.
We conducted a comprehensive search of PubMed using both the National Library of Medicine's Medical Subject Headings and key terms to identify studies that attempted to develop and/or test composite score instruments for asthma control. We classified instruments as core (required in future studies), supplemental (used according to study aims and standardized), or emerging (requiring validation and standardization). This work was discussed at a National Institutes of Health-organized workshop convened in March 2010 and finalized in September 2011.
We identified 17 composite score instruments with published validation information; all had comparable content. Eight instruments demonstrated responsiveness over time; 3 demonstrated responsiveness to treatment. A minimal clinically important difference has been established for 3 instruments. The instruments have demographic limitations; some are proprietary, and their use could be limited by cost.
Two asthma composite score instruments are sufficiently validated for use in adult populations, but additional research is necessary to validate their use in nonwhite populations. Gaps also exist in validating instruments for pediatric populations.
目前的哮喘指南建议评估患者的哮喘控制水平。因此,哮喘控制作为临床研究的结果指标越来越多地被使用。已经开发了几种综合评估工具来衡量哮喘控制。
美国国立卫生研究院和联邦机构召集了一个专家组,提出最适合在未来哮喘研究中使用的哮喘控制综合评估工具的标准化综合评分。
我们使用美国国立卫生研究院的医学主题词和关键词对 PubMed 进行了全面搜索,以确定尝试开发和/或测试哮喘控制综合评分工具的研究。我们将工具分为核心(未来研究中必需的)、补充(根据研究目的和标准化使用)或新兴(需要验证和标准化)。这项工作在 2010 年 3 月由美国国立卫生研究院组织的一次研讨会上进行了讨论,并在 2011 年 9 月最终确定。
我们确定了 17 种具有已发表验证信息的综合评分工具;所有工具都具有相似的内容。8 种工具具有随时间推移的响应性;3 种工具具有对治疗的响应性。3 种工具已建立最小临床重要差异。这些工具存在人口统计学限制;有些是专有的,其使用可能受到成本限制。
两种哮喘综合评分工具在成人人群中得到了充分验证,但需要进一步研究以验证其在非白人人群中的使用。在验证儿科人群的工具方面也存在差距。