Pharmacoepidemiology and drug safety · 2025
Validation of the US Food and Drug Administration's COVID-19 Disease Severity Categorization for Use in Real-World Data.
СтатьяВалидационное исследованиеПоддержка службы здравоохранения СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Perez-Vilar Silvia, Hua Wei, Kwist Andrew, Ma Yuxin, Dong Diane, Zhang Rongping, Ma Yong, Chavez Andrea, Huang Nina, Sheikh Virginia, Chiang Yiyun, Salone Cedric, Pica Natalie, Zhu Yunfan, Pratt Natasha, Nadimpalli Gita, Pershing Suzann, Wernecke Michael, Cunningham Fran E, Graham David J
Аннотация
BACKGROUND: The US Food and Drug Administration proposed a five-level disease severity categorization for baseline COVID-19 (asymptomatic, mild, moderate, severe, critical).
AIMS: We conducted a pilot study aimed to validate the performance of the ICD-10-CM diagnosis code for COVID-19 (U07.1) and operational definitions (code-based algorithms) for each disease severity category in Medicare administrative data.
MATERIALS & METHODS: We sampled 250 community-dwelling beneficiaries aged ≥ 18 years with a U07.1 code on an inpatient hospital or ambulatory claim between April 1, 2020 and June 18, 2022. We used stratified sampling based on care setting and COVID-19 treatment status and adjusted results using sampling weights. Using medical records as the reference standard, we calculated positive predictive values (PPV) and 95% confidence intervals (CI). We conducted prespecified secondary analyses to improve algorithm performance by using refined disease definitions.
RESULTS: We received medical records for 190 (77%) beneficiaries. Of these, 171 had a positive SARS-CoV-2 test result. The PPV of the COVID-19 diagnosis code was 89% (CI: 83%-93%) overall, 88% (CI: 80%-93%) in the ambulatory setting, and 93% (CI: 82%-97%) in the inpatient setting. The operational definition for disease severity varied in performance by severity level and measurement strategy. The best performance was: PPV for asymptomatic and mild combined 69% (CI: 59%-77%), PPV for moderate 58% (CI: 34%-78%); PPV for severe 42% (CI: 27%-59%); and PPV for critical 85% (CI: 57%-96%).
DISCUSSION: The code, U07.1, reliably identified beneficiaries with COVID-19 in both ambulatory and inpatient settings. The operational definition to classify COVID-19 disease severity notably improved performance when we implemented selected refinements.
CONCLUSION: Researchers should consider the moderate performance of the proposed operational definitions when using administrative claims data to assess COVID-19 disease severity.
AIMS: We conducted a pilot study aimed to validate the performance of the ICD-10-CM diagnosis code for COVID-19 (U07.1) and operational definitions (code-based algorithms) for each disease severity category in Medicare administrative data.
MATERIALS & METHODS: We sampled 250 community-dwelling beneficiaries aged ≥ 18 years with a U07.1 code on an inpatient hospital or ambulatory claim between April 1, 2020 and June 18, 2022. We used stratified sampling based on care setting and COVID-19 treatment status and adjusted results using sampling weights. Using medical records as the reference standard, we calculated positive predictive values (PPV) and 95% confidence intervals (CI). We conducted prespecified secondary analyses to improve algorithm performance by using refined disease definitions.
RESULTS: We received medical records for 190 (77%) beneficiaries. Of these, 171 had a positive SARS-CoV-2 test result. The PPV of the COVID-19 diagnosis code was 89% (CI: 83%-93%) overall, 88% (CI: 80%-93%) in the ambulatory setting, and 93% (CI: 82%-97%) in the inpatient setting. The operational definition for disease severity varied in performance by severity level and measurement strategy. The best performance was: PPV for asymptomatic and mild combined 69% (CI: 59%-77%), PPV for moderate 58% (CI: 34%-78%); PPV for severe 42% (CI: 27%-59%); and PPV for critical 85% (CI: 57%-96%).
DISCUSSION: The code, U07.1, reliably identified beneficiaries with COVID-19 in both ambulatory and inpatient settings. The operational definition to classify COVID-19 disease severity notably improved performance when we implemented selected refinements.
CONCLUSION: Researchers should consider the moderate performance of the proposed operational definitions when using administrative claims data to assess COVID-19 disease severity.