背景:在全球范围内,免疫抑制的特征和细分为临床风险组的方式存在明显的不一致.这不利于疾病监测工作的准确性和可比性,这对免疫抑制者的护理及其健康结果具有负面影响。这在COVID-19大流行期间尤其明显;尽管集体动机保护这些患者,相互矛盾的临床定义在这段时间内如何监测和管理免疫抑制患者方面造成了国际分歧.我们建议围绕导致免疫抑制的条件及其与COVID-19有关的严重程度建立国际临床共识。然后可以将这些信息形式化为数字表型,以增强疾病监测,并提供对这些患者进行风险优先排序的急需情报。
目的:我们的目的是展示电子德尔菲目标,方法论,和统计方法将有助于解决国际上缺乏共识的问题,并为成人免疫抑制提供COVID-19风险分层表型。\"
方法:利用现有证据证明免疫抑制的成人COVID-19结果不均匀,这项工作将招募50多名世界领先的临床医生,研究,或免疫学或临床风险优先领域的政策专家。经过2轮临床共识构建和1轮总结辩论,这些小组成员将确认应被归类为免疫抑制的医疗状况及其对COVID-19的差异脆弱性。还将提出关于这些风险的时间和剂量依赖性的共识声明。这项工作将迭代进行,小组成员有机会在各轮之间提出澄清问题,并提供持续的反馈以改进问卷项目。统计分析将侧重于答复之间的协议水平。
结果:该方案概述了一种有效的方法,用于提高对COVID-19成人免疫抑制的定义和有意义的细分的共识。小组成员的招募发生在2024年4月至5月之间;实现了为50多名小组成员设定的目标。该研究于5月底启动,数据收集预计于2024年7月结束。
结论:本方案,如果全面实施,将提供一个普遍接受的,临床相关,和成人免疫抑制的电子健康记录兼容表型。除了对COVID-19资源优先排序具有立竿见影的价值外,这项研究及其结果对所有不成比例地影响免疫抑制患者的疾病的临床决策具有前瞻性价值.
■PRR1-10.2196/56271。
BACKGROUND: Globally, there are marked inconsistencies in how immunosuppression is characterized and subdivided into clinical risk groups. This is detrimental to the precision and comparability of disease surveillance efforts-which has negative implications for the care of those who are
immunosuppressed and their health outcomes. This was particularly apparent during the COVID-19 pandemic; despite collective motivation to protect these patients, conflicting clinical definitions created international rifts in how those who were
immunosuppressed were monitored and managed during this period. We propose that international clinical consensus be built around the conditions that lead to immunosuppression and their gradations of severity concerning COVID-19. Such information can then be formalized into a digital phenotype to enhance disease surveillance and provide much-needed intelligence on risk-prioritizing these patients.
OBJECTIVE: We aim to demonstrate how electronic Delphi objectives, methodology, and statistical approaches will help address this lack of consensus internationally and deliver a COVID-19 risk-stratified phenotype for \"adult immunosuppression.\"
METHODS: Leveraging existing evidence for heterogeneous COVID-19 outcomes in adults who are
immunosuppressed, this work will recruit over 50 world-leading clinical, research, or policy experts in the area of immunology or clinical risk prioritization. After 2 rounds of clinical consensus building and 1 round of concluding debate, these panelists will confirm the medical conditions that should be classed as
immunosuppressed and their differential vulnerability to COVID-19. Consensus statements on the time and dose dependencies of these risks will also be presented. This work will be conducted iteratively, with opportunities for panelists to ask clarifying questions between rounds and provide ongoing feedback to improve questionnaire items. Statistical analysis will focus on levels of agreement between responses.
RESULTS: This protocol outlines a robust method for improving consensus on the definition and meaningful subdivision of adult immunosuppression concerning COVID-19. Panelist recruitment took place between April and May of 2024; the target set for over 50 panelists was achieved. The
study launched at the end of May and data collection is projected to end in July 2024.
CONCLUSIONS: This protocol, if fully implemented, will deliver a universally acceptable, clinically relevant, and electronic health record-compatible phenotype for adult immunosuppression. As well as having immediate value for COVID-19 resource prioritization, this exercise and its output hold prospective value for clinical decision-making across all diseases that disproportionately affect those who are immunosuppressed.
UNASSIGNED: PRR1-10.2196/56271.