1. The initial validation of a novel outcome measure in severe burns- the Persistent Organ Dysfunction +Death: Results from a multicenter evaluation
- Author
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Arnold S. Kristof, Jochen Gille, Bong-Sung Kim, Declan Collins, Jan A. Plock, David B. Lumenta, Christian Stoppe, Gabriel Hundeshagen, Andrew G. Day, Ulrich Kneser, Daren K. Heyland, Aileen Hill, Xuran Jiang, Justus P. Beier, University of Zurich, and Heyland, Daren K
- Subjects
Adult ,Male ,Relative risk reduction ,medicine.medical_specialty ,Organ Dysfunction Scores ,Multiple Organ Failure ,610 Medicine & health ,Critical Care and Intensive Care Medicine ,law.invention ,030207 dermatology & venereal diseases ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,Outcome Assessment, Health Care ,Humans ,Medicine ,10266 Clinic for Reconstructive Surgery ,Prospective cohort study ,Aged ,Chi-Square Distribution ,business.industry ,Mortality rate ,Organ dysfunction ,030208 emergency & critical care medicine ,General Medicine ,Length of Stay ,Middle Aged ,2746 Surgery ,3. Good health ,Clinical trial ,Intensive Care Units ,Sample size determination ,Quality of Life ,Emergency Medicine ,Female ,Surgery ,medicine.symptom ,Burns ,2711 Emergency Medicine ,2706 Critical Care and Intensive Care Medicine ,business ,Total body surface area - Abstract
Introduction A need exists to improve the efficiency of clinical trials in burn care. The objective of this study was to validate “Persistent Organ Dysfunction” plus death as endpoint in burn patients and to demonstrate its statistical efficiency. Methods This secondary outcome analysis of a dataset from a prospective international multicenter RCT (RE-ENERGIZE) included patients with burned total body surface area >20% and a 6-month follow-up. Persistent organ dysfunction was defined as persistence of organ dysfunction with life-supportiing technologies and ICU care. Results In the 539 included patients, the prevalence of 0p p+ pdeath was 40% at day 14 and of 27% at day 28. At both timepoints, survivors with POD (vs. survivors without POD) had a higher mortality rate, longer ICU- and hospital-stays, and a reduced quality of life. POD + death as an endpoint could result in reduced sample size requirements for clinical trials. Detecting a 25% relative risk reduction in 28-day mortality would require a sample size of 4492 patients, whereas 1236 patients would be required were 28-day POD + death used. Conclusions POD + death represents a promising composite outcome measure that may reduce the sample size requirements of clinical trials in severe burns patients. Further validation in larger clinical trials is warranted. Study type Prospective cohort study, level of evidence: II
- Published
- 2021
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