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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 Dec 01;24(12):998-1009

Date

08/04/2023

Pubmed ID

37539964

Pubmed Central ID

PMC10688559

DOI

10.1097/PCC.0000000000003331

Scopus ID

2-s2.0-85179013325 (requires institutional sign-in at Scopus site)   6 Citations

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.

Author List

Leland SB, Staffa SJ, Newhams MM, Khemani RG, Marshall JC, Young CC, Maddux AB, Hall MW, Weiss SL, Schwarz AJ, Coates BM, Sanders RC Jr, Kong M, Thomas NJ, Nofziger RA, Cullimore ML, Halasa NB, Loftis LL, Cvijanovich NZ, Schuster JE, Flori H, Gertz SJ, Hume JR, Olson SM, Patel MM, Zurakowski D, Randolph AG, Pediatric Acute Lung and Sepsis Investigator’s Network Pediatric Intensive Care Influenza Study Group (PALISI PICFLU) Investigators and Overcoming COVID-19 Investigators

Author

Rainer G. Gedeit MD Associate Chief Medical Officer in the Children's Administration department at Children's Wisconsin




MESH terms used to index this publication - Major topics in bold

Adolescent
Child
Disease Progression
Humans
Influenza, Human
Respiration, Artificial
Respiratory Insufficiency