Severity, predictors and clinical correlates of Post-COVID syndrome (PCS) in Germany: A prospective, multi-centre, population-based cohort study.

Severity, predictors and clinical correlates of Post-COVID syndrome (PCS) in Germany: A prospective, multi-centre, population-based cohort study.
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DOI:
10.1016/j.eclinm.2022.101549
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发表时间:
2022-09
期刊:
影响因子:
15.1
通讯作者:
Schreiber, Stefan
Schreiber, Stefan
中科院分区:
医学1区
文献类型:
--
作者:
Bahmer, Thomas;Borzikowsky, Christoph;Lieb, Wolfgang;Horn, Anna;Krist, Lilian;Fricke, Julia;Scheibenbogen, Carmen;Rabe, Klaus F.;Maetzler, Walter;Maetzler, Corina;Laudien, Martin;Frank, Derk;Ballhausen, Sabrina;Hermes, Anne;Miljukov, Olga;Haeusler, Karl Georg;El Mokhtari, Nour Eddine;Witzenrath, Martin;Vehreschild, Joerg Janne;Krefting, Dagmar;Pape, Daniel;Montellano, Felipe A.;Kohls, Mirjam;Morbach, Caroline;Stork, Stefan;Reese, Jens-Peter;Keil, Thomas;Heuschmann, Peter;Krawczak, Michael;Schreiber, Stefan

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COVID后综合征(PCS)是COVID-19的一种重要后遗症,其特征是症状持续>3个月,急性期后症状发展,以及既存合并症恶化。PCS的原因和公共卫生影响仍然不清楚,尤其是缺乏有效的手段来评估PCS的存在和严重程度。COVIDOM是一项基于人群的SARS-CoV-2感染的聚合酶链反应(PCR)确诊病例队列研究,于2020年11月15日至2021年9月29日期间通过德国三个地区(基尔、柏林、维尔茨堡)的公共卫生机构招募。主要入选标准是(i)PCR证实的SARS-CoV-2感染和(ii)感染与COVIDOM研究中心访视之间至少6个月的时间。其他入选标准为书面知情同意书和年龄≥18岁。关键排除标准是急性再感染SARS-CoV-2。研究中心访视包括标准化访谈、深入检查和生物材料采购。在子队列Kiel-I中,根据12种长期症状复合物制定PCS(严重程度)评分。两个验证子队列(维尔茨堡/柏林、基尔-II)用于PCS评分复制和识别具有临床意义的预测因子。本研究在clinicaltrials.gov(NCT 04679584)和德国临床研究注册中心(DRKS,DRKS 00023742)注册。在Kiel-I(n = 667,57%为女性),90%的参与者接受了急性COVID-19的门诊治疗。神经系统疾病(61.5%),疲劳(57.1%)和睡眠障碍(57.0%)是感染后6-12个月最常见的持续症状。在各亚队列中(维尔茨堡/柏林,n = 316,52%女性; Kiel-II,n = 459,56%女性),PCS评分越高,健康相关生活质量越低(EQ-5D-5L-VAS/-指数:r = -0 stat 54/ -0 stat 56,所有p < 0·0001)。根据个体参与者的PCS评分,Kiel-I子队列中重度、中度和轻度/无PCS的发生率分别为18.8%、48.2%和32.9%。在两个验证子队列中,PCS评分的统计学显著预测因素包括急性期症状的强度和个人弹性水平。PCS的严重程度可以通过一个易于使用的基于神经网络的评分来量化,该评分反映了急性期疾病负担和一般心理倾向。因此,PCS评分有望促进PCS的临床诊断、其自然病程的科学研究以及治疗干预的发展。COVIDOM研究由网络大学医学(NUM)资助,作为国家流行病队列网络(NAPKON)的一部分。
Post-COVID syndrome (PCS) is an important sequela of COVID-19, characterised by symptom persistence for >3 months, post-acute symptom development, and worsening of pre-existing comorbidities. The causes and public health impact of PCS are still unclear, not least for the lack of efficient means to assess the presence and severity of PCS. COVIDOM is a population-based cohort study of polymerase chain reaction (PCR) confirmed cases of SARS-CoV-2 infection, recruited through public health authorities in three German regions (Kiel, Berlin, Würzburg) between November 15, 2020 and September 29, 2021. Main inclusion criteria were (i) a PCR confirmed SARS-CoV-2 infection and (ii) a period of at least 6 months between the infection and the visit to the COVIDOM study site. Other inclusion criteria were written informed consent and age ≥18 years. Key exclusion criterion was an acute reinfection with SARS-CoV-2. Study site visits included standardised interviews, in-depth examination, and biomaterial procurement. In sub-cohort Kiel-I, a PCS (severity) score was developed based upon 12 long-term symptom complexes. Two validation sub-cohorts (Würzburg/Berlin, Kiel-II) were used for PCS score replication and identification of clinically meaningful predictors. This study is registered at clinicaltrials.gov (NCT04679584) and at the German Registry for Clinical Studies (DRKS, DRKS00023742). In Kiel-I (n = 667, 57% women), 90% of participants had received outpatient treatment for acute COVID-19. Neurological ailments (61·5%), fatigue (57·1%), and sleep disturbance (57·0%) were the most frequent persisting symptoms at 6–12 months after infection. Across sub-cohorts (Würzburg/Berlin, n = 316, 52% women; Kiel-II, n = 459, 56% women), higher PCS scores were associated with lower health-related quality of life (EQ-5D-5L-VAS/-index: r = -0·54/ -0·56, all p < 0·0001). Severe, moderate, and mild/no PCS according to the individual participant's PCS score occurred in 18·8%, 48·2%, and 32·9%, respectively, of the Kiel-I sub-cohort. In both validation sub-cohorts, statistically significant predictors of the PCS score included the intensity of acute phase symptoms and the level of personal resilience. PCS severity can be quantified by an easy-to-use symptom-based score reflecting acute phase disease burden and general psychological predisposition. The PCS score thus holds promise to facilitate the clinical diagnosis of PCS, scientific studies of its natural course, and the development of therapeutic interventions. The COVIDOM study is funded by the Network University Medicine (NUM) as part of the National Pandemic Cohort Network (NAPKON).
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