Sedation protocol for critically ill pediatric patients--reply.

Letters aspirin use based on data collected at baseline and at addi- tional time points prior to hospitalization for pneumonia if these data were available. Aspirin use was similar between the 2 groups, suggesting that confounding by unaccounted aspirin use is unlikely. We agree with the authors that advanced age is an important risk factor for CVD after pneumonia. This is sup- ported by the substantial difference in incident CVD after hospitalization for pneumonia between the 2 cohorts that we analyzed (CHS: mean age of 73 years and 10-year risk of 35% for CVD vs ARIC study: mean age of 55 years and 10-year risk of 16.5% for CVD). In regard to their point about the severity of pneumonia being an important risk factor for subsequent CVD, we also agree that previous studies sup- port this concept. However, our study was not designed to address this question. Instead, we chose to perform a strati- fied analysis by pneumonia severity to determine whether the association between hospitalization for this infection and increased risk of CVD was present in cases of both severe and nonsevere pneumonia. We agree with Violi and colleagues that randomized clini- cal trials of interventions to reduce CVD after hospitalization for pneumonia are needed, and that older adults with severe pneumonia would be a high-risk group in which these inter- ventions could demonstrate benefit. Vicente F. Corrales-Medina, MD, MSc Karina N. Alvarez, MS Sachin Yende, MD, MS Author Affiliations: Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada (Corrales-Medina); Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, University of Pittsburgh, Pittsburgh, Pennsylvania (Alvarez, Yende). Corresponding Author: Sachin Yende, MD, MS, Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh, 3550 Terrace St, Pittsburgh, PA 15261 (yendes@upmc.edu). Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. Sedation Protocol for Critically Ill Pediatric Patients To the Editor In the Randomized Evaluation of Sedation Titra- tion for Respiratory Failure (RESTORE) trial, Dr Curley and colleagues 1 found that a nurse-implemented, goal-directed se- dation protocol for children undergoing mechanical ventila- tion for acute respiratory failure did not reduce the duration of mechanical ventilation compared with standard of care. In an accompanying Editorial, Dr Mehta 2 raised the question of whether a low adherence rate to a complex protocol (71%- 100%) or a difference in administered drugs with bioaccumu- lation between the groups contributed to the null findings. This large randomized clinical trial of sedation using a bedside pro- tocol in critically ill children may have been confounded by an intervention group who were younger and less sick and who received more frequent assessments. Previous work in adult critical care has demonstrated 3 fewer days of mechanical ventilation through the use of a multidisciplinary team bundle approach to care based on an ABCDE (awakening and breathing coordination, delirium monitoring/management, and early exercise/mobility) protocol. 3 This approach has allowed patients to be more awake to participate in early mobility and physical therapy, potentially minimizing myopathy acquired in the intensive care unit and reducing time spent receiving mechanical ventilation. Previous work by Curley et al 4 has demonstrated that the State Behavioral Scale (SBS) has an interrater reliability score of 0.44 to 0.76 in younger patients. I question whether the au- thors’ null findings may result from the variation between bed- side nurses or between different centers because the unit of randomization was the pediatric intensive care unit (PICU). Were measures of variation between bedside nurses deter- mined prior to the study? Was consideration given to addi- tional measurements for level of sedation prior to the study? Also, could a high turnover of PICU nurses have led to a rela- tively inexperienced workforce responsible for sedation as- sessments? Do the authors have any further data that may of- fer insight into how turnover or experience may have confounded the study? Kenneth E. Remy, MD Author Affiliation: Division of Pediatric Critical Care Medicine, Washington University, St Louis, Missouri. Corresponding Author: Kenneth E. Remy, MD, Department of Pediatrics, Division of Pediatric Critical Care Medicine, Washington University, 660 S Euclid Ave, St Louis, MO 63110 (remy_k@kids.wustl.edu). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. 1. Curley MA, Wypij D, Watson RS, et al; RESTORE Study Investigators and the Pediatric Acute Lung Injury and Sepsis Investigators Network. Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial. JAMA. 2015;313(4): 2. Mehta S. Protocolized sedation in critically ill children. JAMA. 2015;313(4):363- 3. Balas MC, Vasilevskis EE, Olsen KM, et al. Effectiveness and safety of the awakening and breathing coordination, delirium monitoring/management, and early exercise/mobility bundle. Crit Care Med. 2014;42(5):1024-1036. 4. Curley MAQ, Harris SK, Fraser KA, Johnson RA, Arnold JH. State Behavioral Scale: a sedation assessment instrument for infants and young children supported on mechanical ventilation. Pediatr Crit Care Med. 2006;7(2):107-114. In Reply Dr Remy is concerned that null findings of the RESTORE clinical trial may have been the result of the clus- ter randomized design leading to variation in sedation assessments between bedside nurses and among different centers. Remy asks whether measures of variation between bedside nurses were determined prior to the study, whether additional sedation measures were considered, and whether nurse turnover or experience could have confounded study results. During the RESTORE start-up phase, all PICUs imple- mented the SBS as a unit-based standard of care. The SBS was selected because it was the only valid and reliable sedation assessment instrument specific for intubated pediatric patients. The weighted κ scores of 0.44 to 0.76 noted by JAMA May 5, 2015 Volume 313, Number 17 (Reprinted) Copyright 2015 American Medical Association. All rights reserved. Downloaded From: http://jama.jamanetwork.com/ by a UCSF LIBRARY User on 07/08/2015 jama.com