University of Wisconsin, Madison, Wisconsin, USA.
J Allergy Clin Immunol. 2012 Mar;129(3 Suppl):S1-8. doi: 10.1016/j.jaci.2011.12.985.
Asthma clinical research will highly benefit from standardization of major outcomes in terms of definition and assessment methodology. This will permit useful comparisons across interventional or observational studies and will allow more effective data sharing.
National Institutes of Health (NIH) institutes and the Agency for Healthcare Research and Quality convened a workshop involving 7 expert subcommittees to propose which asthma outcomes should be assessed with standardized methodology in future asthma clinical research studies.
Each subcommittee utilized comprehensive literature reviews and expert opinion to compile a list of asthma outcomes and classified them as either core (required in future studies), supplemental (to be used according to study aims and standardized), or emerging (requiring validation and standardization). This work was discussed at an NIH-organized workshop in March 2010 and finalized in September 2011.
Outcomes for study participant characterization, as well as for prospective clinical trial intervention and observational studies, were proposed for adults and children, and methodologies for outcome collection and reporting were determined. Furthermore, the workshop identified areas in which new outcomes or instruments for their measurement need to be developed and validated.
Standardized outcomes for clinical research in asthma have been proposed. Participating NIH institutes and other federal agencies will consider these recommendations in future clinical research initiatives in asthma.
哮喘临床研究将从主要结局的定义和评估方法的标准化中受益匪浅。这将允许在干预性或观察性研究之间进行有用的比较，并允许更有效的数据共享。
美国国立卫生研究院（NIH）研究所和医疗保健研究与质量局召集了一个研讨会，涉及 7 个专家小组委员会，提出在未来的哮喘临床研究中应使用标准化方法评估哪些哮喘结局。
每个小组委员会利用全面的文献回顾和专家意见，编制了一份哮喘结局清单，并将其分为核心（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 NIH 组织的研讨会上进行了讨论，并在 2011 年 9 月最终确定。
为研究参与者特征、前瞻性临床试验干预和观察性研究提出了成人和儿童的研究结果，并确定了结果收集和报告的方法。此外，研讨会确定了需要开发和验证新的结果或测量工具的领域。
已经提出了哮喘临床研究的标准化结局。参与 NIH 研究所和其他联邦机构将在未来的哮喘临床研究计划中考虑这些建议。
