Correction to: Methods in the design and implementation of the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) clinical trial.

AbstractFollowing publication of the original article [1], the authors notified us of a typing error in spelling Dr. Asario's name. The original publication has been corrected.

Methods in the design and implementation of the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) clinical trial.

BACKGROUND: Few papers discuss the pragmatics of conducting large, cluster randomized clinical trials. Here we describe the sequential steps taken to develop methods to implement the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) trial that tested the effect of a nurse-implemented, goal-directed, comfort algorithm on clinical outcomes in pediatric patients with acute respiratory failure. METHODS: After development in a single institution, the RESTORE intervention was pilot-tested in two pediatric intensive care units (PICUs) to evaluate safety and feasibility. After the pilot, the RESTORE intervention was simplified to enhance reproducibility across multiple PICUs. The final RESTORE trial was developed as a cluster randomized clinical trial where the unit of randomization was the PICU, stratified by PICU size, and the unit of inference was the patient. Study execution was revised based on our Data and Safety Monitoring Board's recommendation to consult with the Department of Health and Human Services' Office of Human Research Protection (OHRP) on how best to consent eligible subjects. OHRP deemed that the RESTORE intervention posed greater than minimal risk and that all enrolled subjects provide consent reflecting their level of participation. RESULTS: Thirty-one PICUs of varying size, organization and academic affiliation participated and over 2800 critically ill infants and children supported on mechanical ventilation for acute pulmonary disease were enrolled. The primary outcome for the trial was the duration of mechanical ventilation; secondary outcomes included time awake and comfortable, total sedative exposure and iatrogenic withdrawal symptoms. Throughout the clinical trial the investigative team worked to maintain treatment fidelity, enrollment milestones and co-investigator enthusiasm. We considered the potential impact of competing clinical trials through a decision-making framework. CONCLUSIONS: The RESTORE clinical trial was a large and complex multicenter study that has provided the necessary evidence to guide sedation practices in the field of pediatric critical care. Specific issues that were unique to this trial included level of consent, adding clinical sites to augment enrollment and evaluating the potential impact of competing clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov , Identifiers: Pilot trial: NCT00142766 ; Retrospectively registerd on 2 September 2005. Cluster randomized trial: NCT00814099 . Registered on 23 December 2008.

Wound care challenges in children and adults with spina bifida: an open-cohort study.

Skin breakdown is a frequent concern for individuals with spina bifida. We explored wound incidence in patients with spina bifida and how it varies across a person's life span and functional neurologic level. We examined the settings in which skin breakdown most commonly occurred, looking for evidence of chronic, non-healing wounds. We also sought to develop criteria to improve wound monitoring. We identified reported wound episodes in an open-cohort study over a 13-year period, examining the hospital and outpatient clinical records of spina bifida patients at Children's National Medical Center (CNMC). Current age, age at wound presentation, sex, weight, functional neurologic level, wound location, setting in which the wound was acquired, the development of a chronic wound, and presence of a shunt were recorded. Of the 376 patients in our clinical population, 123 (average age: 18.8 years, range: infancy-56 years) developed a total of 375 wounds; the majority of patients who developed one wound went on to develop one or more additional wounds, and 20 patients developed chronic wounds. Our data suggest that age bracket (adolescents), wheelchair use, and bare feet, as well as possibly obesity and reduced executive functioning, are key risk factors for wound development. These findings have led to a focused effort to increase wound education and prevention. In addition we report on our early experience using a wound care specialist to champion this initiative.

The Withdrawal Assessment Tool-1 (WAT-1): an assessment instrument for monitoring opioid and benzodiazepine withdrawal symptoms in pediatric patients.

OBJECTIVE: To develop and test the validity and reliability of the Withdrawal Assessment Tool-1 for monitoring opioid and benzodiazepine withdrawal symptoms in pediatric patients. DESIGN: Prospective psychometric evaluation. Pediatric critical care nurses assessed eligible at-risk pediatric patients for the presence of 19 withdrawal symptoms and rated the patient's overall withdrawal intensity using a Numeric Rating Scale where zero indicated no withdrawal and 10 indicated worst possible withdrawal. The 19 symptoms were derived from the Opioid and Benzodiazepine Withdrawal Score, the literature and expert opinion. SETTING: Two pediatric intensive care units in university-affiliated academic children's hospitals. PATIENTS: Eighty-three pediatric patients, median age 35 mos (interquartile range: 7 mos-10 yrs), recovering from acute respiratory failure who were being weaned from more than 5 days of continuous infusion or round-the-clock opioid and benzodiazepine administration. INTERVENTIONS: Repeated observations during analgesia and sedative weaning. A total of 1040 withdrawal symptom assessments were completed, with a median (interquartile range) of 11 (6-16) per patient over 6.6 (4.8-11) days. MEASUREMENTS AND MAIN RESULTS: Generalized linear modeling was used to analyze each symptom in relation to withdrawal intensity ratings, adjusted for site, subject, and age group. Symptoms with high redundancy or low levels of association with withdrawal intensity ratings were dropped, resulting in an 11-item (12-point) scale. Concurrent validity was indicated by high sensitivity (0.872) and specificity (0.880) for Withdrawal Assessment Tool-1 > 3 predicting Numeric Rating Scale > 4. Construct validity was supported by significant differences in drug exposure, length of treatment and weaning from sedation, length of mechanical ventilation and intensive care unit stay for patients with Withdrawal Assessment Tool-1 scores > 3 compared with those with lower scores. CONCLUSIONS: The Withdrawal Assessment Tool-1 shows excellent preliminary psychometric performance when used to assess clinically important withdrawal symptoms in the pediatric intensive care unit setting. Further psychometric evaluation in diverse at-risk groups is needed.