Validation of the SOS-PD scale for assessment of pediatric delirium: a multicenter study.

BACKGROUNDS: Reports of increasing incidence rates of delirium in critically ill children are reason for concern. We evaluated the measurement properties of the pediatric delirium component (PD-scale) of the Sophia Observation Withdrawal Symptoms scale Pediatric Delirium scale (SOS-PD scale). METHODS: In a multicenter prospective observational study in four Dutch pediatric ICUs (PICUs), patients aged ≥ 3 months and admitted for ≥ 48 h were assessed with the PD-scale thrice daily. Criterion validity was assessed: if the PD-scale score was ≥ 4, a child psychiatrist clinically assessed the presence or absence of PD according to the Diagnostic and statistical manual of mental disorders (DSM)-IV. In addition, the child psychiatrist assessed a randomly selected group to establish the false-negative rate. The construct validity was assessed by calculating the Pearson coefficient (rp) for correlation between the PD-scale and Cornell Assessment Pediatric Delirium (CAP-D) scores. Interrater reliability was determined by comparing paired nurse-researcher PD-scale assessments and calculating the intraclass correlation coefficient (ICC). RESULTS: Four hundred eighty-five patients with a median age of 27.0 months (IQR 8-102) were included, of whom 48 patients were diagnosed with delirium by the child psychiatrist. The PD-scale had overall sensitivity of 92.3% and specificity of 96.5% compared to the psychiatrist diagnosis for a cutoff score ≥4 points. The rp between the PD-scale and the CAP-D was 0.89 (CI 95%, 0.82-0.93; p < 0.001). The ICC of 75 paired nurse-researcher observations was 0.99 (95% CI, 0.98-0.99). CONCLUSIONS: The PD-scale has good reliability and validity for early screening of PD in critically ill children. It can be validly and reliably used by nurses to this aim.

Monitoring Haloperidol Plasma Concentration and Associated Adverse Events in Critically Ill Children With Delirium: First Results of a Clinical Protocol Aimed to Monitor Efficacy and Safety.

OBJECTIVES: As delirium in critically ill children is increasingly recognized, more children are treated with the antipsychotic drug haloperidol, while current dosing guidelines are lacking solid evidence and appear to be associated with a high risk of adverse events. We aim to report on the safety and efficacy of a recently implemented clinical dose-titration protocol with active monitoring of adverse events. DESIGN: From July 2014 until June 2015, when a potential delirium was identified by regular delirium scores and confirmed by a child psychiatrist, haloperidol was prescribed according to the Dutch Pediatric Formulary. Daily, adverse events were systematically assessed, haloperidol plasma concentrations were measured, and delirium symptoms followed. Dependent on the clinical response, plasma concentration, and adverse event, the dose was adjusted. SETTING: A 28-bed tertiary PICU in the Netherlands. PATIENTS: All patients admitted to the PICU diagnosed with delirium. INTERVENTION: Treatment with haloperidol according to a dose-titration protocol MEASUREMENTS AND MAIN RESULTS:: Thirteen children (median age [range] 8.3 yr [0.4-13.8 yr]) received haloperidol, predominantly IV (median dose [range] 0.027 mg/kg/d [0.005-0.085 mg/kg/d]). In all patients, pediatric delirium resolved, but five of 13 patients developed possible adverse event. These were reversed after biperiden (n = 2), discontinuing (n = 3), and/or lowering the dose (n = 3). Plasma concentrations were all below the presumed therapeutic threshold of 3-12 µg/L. CONCLUSIONS: Prospective systematic monitoring of adverse event in critically ill children receiving haloperidol revealed a significant proportion of possible adverse events. Adverse event developed despite low plasma concentrations and recommended dose administration in the majority of the patients. Our data suggest that haloperidol can potentially improve pediatric delirium, but it might also put patients at risk for developing adverse events.

Sophia Observation withdrawal Symptoms-Paediatric Delirium scale: A tool for early screening of delirium in the PICU.

BACKGROUND: Delirium in critically ill children is a severe neuropsychiatric disorder which has gained increased attention from clinicians. Early identification of delirium is essential for successful management. The Sophia Observation withdrawal Symptoms-Paediatric Delirium (SOS-PD) scale was developed to detect Paediatric Delirium (PD) at an early stage. OBJECTIVE: The aim of this study was to determine the measurement properties of the PD component of the SOS-PD scale in critically ill children. METHODS: A prospective, observational study was performed in patients aged 3 months or older and admitted for more than 48h. These patients were assessed with the SOS-PD scale three times a day. If the SOS-PD total score was 4 or higher in two consecutive observations, the child psychiatrist was consulted to assess the diagnosis of PD using the Diagnostic and Statistical Manual-IV criteria as the "gold standard". The child psychiatrist was blinded to outcomes of the SOS-PD. The interrater reliability of the SOS-PD between the care-giving nurse and a researcher was calculated with the intraclass correlation coefficient (ICC). RESULTS: A total of 2088 assessments were performed in 146 children (median age 49 months; IQR 13-140). The ICC of 16 paired nurse-researcher observations was 0.90 (95% CI 0.70-0.96). We compared 63 diagnoses of the child psychiatrist versus SOS-PD assessments in 14 patients, in 13 of whom the diagnosis of PD was confirmed. The sensitivity was 96.8% (95% CI 80.4-99.5%) and the specificity was 92.0% (95% CI 59.7-98.9%). CONCLUSIONS: The SOS-PD scale shows promising validity for early screening of PD. Further evidence should be obtained from an international multicentre study.

Long-term follow-up after successful electroconvulsive therapy for depression: a 4- to 8-year naturalistic follow-up study.

OBJECTIVES: A long-term follow-up of depressed patients responsive to electroconvulsive therapy (ECT) with intensive pre-ECT pharmacotherapy treatment failure who also participated in a 6-month trial directly post-ECT in which imipramine was compared with placebo for relapse prevention. METHODS: A total of 26 patients responsive to ECT who participated in the 6-month continuation trial were invited 4 to 8 years later to assess their follow-up status. The groups with and without relapse within 6 months were compared with regard to recurrence of depression up to 8 years later. Recurrence was defined as a new episode of depression that needed antidepressant medication and/or readmission in hospital and/or a new ECT course. RESULTS: At the time of follow-up (mean duration, 6.8 years), the recurrence rate of depression for the total sample was 42.3%. There was no significant difference in the recurrence rates and number of recurrences between the nonrelapse and relapse groups. The small study population limits generalization of the results; the design of the study is naturalistic and retrospective. CONCLUSION: In our small sample of depressed patients with pharmacotherapy treatment failure, recurrence is not influenced by relapse after terminating ECT. Continuation of medication started immediately after ECT seems to be an important factor in preventing recurrence.