Document Type
Article
Publication Date
12-1-2023
Identifier
DOI: 10.1097/PCC.0000000000003331; PMCID: PMC10688559
Abstract
OBJECTIVES: To develop, evaluate, and explore the use of a pediatric ordinal score as a potential clinical trial outcome metric in children hospitalized with acute hypoxic respiratory failure caused by viral respiratory infections.
DESIGN: We modified the World Health Organization Clinical Progression Scale for pediatric patients (CPS-Ped) and assigned CPS-Ped at admission, days 2-4, 7, and 14. We identified predictors of clinical improvement (day 14 CPS-Ped ≤ 2 or a three-point decrease) using competing risks regression and compared clinical improvement to hospital length of stay (LOS) and ventilator-free days. We estimated sample sizes (80% power) to detect a 15% clinical improvement.
SETTING: North American pediatric hospitals.
PATIENTS: Three cohorts of pediatric patients with acute hypoxic respiratory failure receiving intensive care: two influenza (pediatric intensive care influenza [PICFLU], n = 263, 31 sites; PICFLU vaccine effectiveness [PICFLU-VE], n = 143, 17 sites) and one COVID-19 ( n = 237, 47 sites).
INTERVENTIONS: None.
MEASUREMENTS AND MAIN RESULTS: Invasive mechanical ventilation rates were 71.4%, 32.9%, and 37.1% for PICFLU, PICFLU-VE, and COVID-19 with less than 5% mortality for all three cohorts. Maximum CPS-Ped (0 = home at respiratory baseline to 8 = death) was positively associated with hospital LOS ( p < 0.001, all cohorts). Across the three cohorts, many patients' CPS-Ped worsened after admission (39%, 18%, and 49%), with some patients progressing to invasive mechanical ventilation or death (19%, 11%, and 17%). Despite this, greater than 76% of patients across cohorts clinically improved by day 14. Estimated sample sizes per group using CPS-Ped to detect a percentage increase in clinical improvement were feasible (influenza 15%, n = 142; 10%, n = 225; COVID-19, 15% n = 208) compared with mortality ( n > 21,000, all), and ventilator-free days (influenza 15%, n = 167).
CONCLUSIONS: The CPS-Ped can be used to describe the time course of illness and threshold for clinical improvement in hospitalized children and adolescents with acute respiratory failure from viral infections. This outcome measure could feasibly be used in clinical trials to evaluate in-hospital recovery.
Journal Title
Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies
Volume
24
Issue
12
First Page
998
Last Page
1009
MeSH Keywords
Adolescent; Humans; Child; SARS-CoV-2; Influenza, Human; COVID-19; Respiration, Artificial; Respiratory Distress Syndrome; Outcome Assessment, Health Care; Respiratory Insufficiency; Disease Progression
Keywords
SARS-CoV-2; Influenza; COVID-19; Artificial Respiration; Respiratory Distress Syndrome; Health Care Outcome Assessment; Respiratory Insufficiency; Disease Progression
Recommended Citation
Leland SB, Staffa SJ, Newhams MM, et al. The Modified Clinical Progression Scale for Pediatric Patients: Evaluation as a Severity Metric and Outcome Measure in Severe Acute Viral Respiratory Illness. Pediatr Crit Care Med. 2023;24(12):998-1009. doi:10.1097/PCC.0000000000003331
Comments
Grants and funding
This article is available under the Creative Commons CC-BY-NC-ND license and permits non-commercial use of the work as published, without adaptation or alteration provided the work is fully attributed.
Publisher' s Link: https://journals.lww.com/pccmjournal/fulltext/2023/12000/the_modified_clinical_progression_scale_for.4.aspx