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Prospective validation of the 4C prognostic models for adults hospitalised with COVID-19 using the ISARIC WHO Clinical Characterisation Protocol
Thorax ( IF 9.0 ) Pub Date : 2022-06-01 , DOI: 10.1136/thoraxjnl-2021-217629
Stephen R Knight 1 , Rishi K Gupta 2 , Antonia Ho 3 , Riinu Pius 1 , Iain Buchan 4, 5 , Gail Carson 6 , Thomas M Drake 1 , Jake Dunning 7, 8 , Cameron J Fairfield 1 , Carrol Gamble 9 , Christopher A Green 10 , Sophie Halpin 9 , Hayley E Hardwick 11 , Karl A Holden 11 , Peter W Horby 6 , Clare Jackson 9 , Kenneth A Mclean 1 , Laura Merson 6 , Jonathan S Nguyen-Van-Tam 12 , Lisa Norman 1 , Piero L Olliaro 13 , Mark G Pritchard 13 , Clark D Russell 14 , Catherine A Shaw 1 , Aziz Sheikh 15 , Tom Solomon 11 , Cathie Sudlow 16 , Olivia V Swann 17 , Lance C W Turtle 18, 19 , Peter J M Openshaw 20 , J Kenneth Baillie 21 , Annemarie Docherty 1 , Malcolm G Semple 11, 22 , Mahdad Noursadeghi 23 , Ewen M Harrison 24 , ,
Affiliation  

Purpose To prospectively validate two risk scores to predict mortality (4C Mortality) and in-hospital deterioration (4C Deterioration) among adults hospitalised with COVID-19. Methods Prospective observational cohort study of adults (age ≥18 years) with confirmed or highly suspected COVID-19 recruited into the International Severe Acute Respiratory and emerging Infections Consortium (ISARIC) WHO Clinical Characterisation Protocol UK (CCP-UK) study in 306 hospitals across England, Scotland and Wales. Patients were recruited between 27 August 2020 and 17 February 2021, with at least 4 weeks follow-up before final data extraction. The main outcome measures were discrimination and calibration of models for in-hospital deterioration (defined as any requirement of ventilatory support or critical care, or death) and mortality, incorporating predefined subgroups. Results 76 588 participants were included, of whom 27 352 (37.4%) deteriorated and 12 581 (17.4%) died. Both the 4C Mortality (0.78 (0.77 to 0.78)) and 4C Deterioration scores (pooled C-statistic 0.76 (95% CI 0.75 to 0.77)) demonstrated consistent discrimination across all nine National Health Service regions, with similar performance metrics to the original validation cohorts. Calibration remained stable (4C Mortality: pooled slope 1.09, pooled calibration-in-the-large 0.12; 4C Deterioration: 1.00, –0.04), with no need for temporal recalibration during the second UK pandemic wave of hospital admissions. Conclusion Both 4C risk stratification models demonstrate consistent performance to predict clinical deterioration and mortality in a large prospective second wave validation cohort of UK patients. Despite recent advances in the treatment and management of adults hospitalised with COVID-19, both scores can continue to inform clinical decision making. Trial registration number [ISRCTN66726260][1]. Access to all data and samples collected by ISARIC4C are controlled by an Independent Data and Materials Access Committee composed of representatives of research funders, academia, clinical medicine, public health, and industry. The application process for access to the data is available on the [ISARIC4C website][2] (). We welcome applications for data and material access via our Independent Data And Material Access Committee ([https://isaric4c.net][3]). [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=ISRCTN66726260&atom=%2Fthoraxjnl%2F77%2F6%2F606.atom [2]: https://isaric4c.net/sample_access [3]: https://isaric4c.net/

中文翻译:


使用 ISARIC WHO 临床特征协议对因 COVID-19 住院的成人的 4C 预后模型进行前瞻性验证



目的 前瞻性验证两个风险评分以预测因 COVID-19 住院的成人的死亡率 (4C Mortality) 和院内病情恶化 (4C Deterioration)。方法 对国际严重急性呼吸道和新发感染联盟 (ISARIC) 世界卫生组织英国临床特征方案 (CCP-UK) 研究中招募的确诊或高度疑似 COVID-19 的成年人(年龄≥18 岁)进行前瞻性观察队列研究,在全国 306 家医院进行英格兰、苏格兰和威尔士。患者于2020年8月27日至2021年2月17日期间招募,在最终数据提取之前至少随访4周。主要结果指标是院内病情恶化(定义为任何通气支持或重症监护或死亡的要求)和死亡率模型的区分和校准,纳入预定义的亚组。结果 纳入 76 588 名参与者,其中 27 352 名(37.4%)病情恶化,12 581 名(17.4%)死亡。 4C 死亡率(0.78(0.77 至 0.78))和 4C 恶化评分(汇总 C 统计量 0.76(95% CI 0.75 至 0.77))在所有九个国家卫生服务区域中都表现出一致的歧视,其绩效指标与原始验证相似队列。校准保持稳定(4C 死亡率:汇总斜率 1.09,汇总大校准 0.12;4C 恶化:1.00,–0.04),在英国第二次大流行住院期间无需进行时间重新校准。结论 在大型前瞻性第二波英国患者验证队列中,两种 4C 风险分层模型在预测临床恶化和死亡率方面表现出一致的性能。 尽管最近在治疗和管理因 COVID-19 住院的成人方面取得了进展,但这两个评分仍可以继续为临床决策提供信息。试用注册号[ISRCTN66726260][1]。 ISARIC4C 收集的所有数据和样本的访问由独立数据和材料访问委员会控制,该委员会由研究资助者、学术界、临床医学、公共卫生和工业界的代表组成。访问数据的申请流程可在 [ISARIC4C 网站][2] ( )。我们欢迎通过我们的独立数据和材料访问委员会 ([https://isaric4c.net][3]) 申请数据和材料访问。 [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=ISRCTN66726260&atom=%2Fthoraxjnl%2F77%2F6%2F606.atom [2]: https://isaric4c.net/sample_access [3]: https://isaric4c.网/
更新日期:2022-05-18
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