Latent class analysis of post-acute sequelae of SARS-CoV-2 infection.

IF 1.2 4区 医学 Q4 PHARMACOLOGY & PHARMACY Journal of Biopharmaceutical Statistics Pub Date : 2024-11-16 DOI:10.1080/10543406.2024.2424844
Xiaowu Sun, Jonathan P DeShazo, Laura Anatale-Tardiff, Manuela Di Fusco, Kristen E Allen, Thomas M Porter, Henriette Coetzer, Santiago M C Lopez, Laura Puzniak, Joseph C Cappelleri
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Abstract

Symptoms post-SARS-CoV-2 infection may persist for months and cause significant impairment and impact to quality of life. Acute symptoms of SARS-CoV-2 infection are well studied, yet data on clusters of symptoms over time, or post-acute sequelae of SARS-CoV-2 infection (PASC), are limited. We aim to characterize PASC phenotypes by identifying symptom clusters over a six-month period following infection in individuals vaccinated (boosted and not) and those unvaccinated. Subjects with ≥1 self-reported symptom and positive RT-PCR for SARS-CoV-2 at CVS Health US test sites were recruited between January and April 2022. Patient-reported outcomes symptoms, health-related quality of life (HRQoL), work productivity and activity impairment (WPAI) were captured at 1 month, 3 months, and 6 months post-acute infection. Phenotypes of PASC were determined based on subject matter knowledge and balanced consideration of statistical criteria (lower AIC, lower BIC, and adequate entropy) and interpretability. Generalized estimation equation approach was used to investigate relationship between QoL, WPAI and number of symptoms and identified phenotypes, and relationship between phenotypes and vaccination status as well. LCA identified three phenotypes that are primarily differentiated by number of symptoms. These three phenotypes remained consistent across time periods. Subjects with more symptoms were associated with lower HRQoL, and worse WPAI scores. Vaccinated individuals were more likely to be in the low symptom burden latent classes at all time points compared to unvaccinated individuals.

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对 SARS-CoV-2 感染后急性后遗症的潜伏类分析。
感染 SARS-CoV-2 后的症状可能会持续数月之久,对生活质量造成严重损害和影响。对 SARS-CoV-2 感染的急性症状研究较多,但有关长期症状群或 SARS-CoV-2 感染急性后遗症(PASC)的数据却很有限。我们的目的是通过识别已接种疫苗(加强型和非加强型)和未接种疫苗的人在感染后六个月内的症状群,来描述 PASC 的表型。2022 年 1 月至 4 月期间,在美国 CVS Health 检测点招募了自我报告症状≥1 次且 SARS-CoV-2 RT-PCR 阳性的受试者。采集急性感染后 1 个月、3 个月和 6 个月的患者报告结果,包括症状、健康相关生活质量 (HRQoL)、工作效率和活动障碍 (WPAI)。PASC 的表型是根据主题知识以及对统计标准(较低的 AIC、较低的 BIC 和足够的熵)和可解释性的平衡考虑确定的。采用广义估计方程法研究了 QoL、WPAI 和症状数量与已确定表型之间的关系,以及表型与疫苗接种状况之间的关系。LCA 确定了三种主要由症状数量区分的表型。这三种表型在不同时期保持一致。症状较多的受试者与较低的 HRQoL 和较差的 WPAI 分数有关。与未接种疫苗的人相比,接种疫苗的人在所有时间点都更有可能属于低症状负担潜伏类。
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来源期刊
Journal of Biopharmaceutical Statistics
Journal of Biopharmaceutical Statistics 医学-统计学与概率论
CiteScore
2.50
自引率
18.20%
发文量
71
审稿时长
6-12 weeks
期刊介绍: The Journal of Biopharmaceutical Statistics, a rapid publication journal, discusses quality applications of statistics in biopharmaceutical research and development. Now publishing six times per year, it includes expositions of statistical methodology with immediate applicability to biopharmaceutical research in the form of full-length and short manuscripts, review articles, selected/invited conference papers, short articles, and letters to the editor. Addressing timely and provocative topics important to the biostatistical profession, the journal covers: Drug, device, and biological research and development; Drug screening and drug design; Assessment of pharmacological activity; Pharmaceutical formulation and scale-up; Preclinical safety assessment; Bioavailability, bioequivalence, and pharmacokinetics; Phase, I, II, and III clinical development including complex innovative designs; Premarket approval assessment of clinical safety; Postmarketing surveillance; Big data and artificial intelligence and applications.
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