Twenty-four-hour hospitalization for patients initiating systemic propranolol therapy for infantile hemangiomas--is it indicated?

In recent years, oral propranolol has risen from serendipitous discovery to first-line, albeit off-label, therapy for infantile hemangiomas (IHs). This retrospective study explored the utility of a 24-hour hospitalization for the initiation of propranolol therapy in children with problematic IHs by evaluating the effects of systemic propranolol on hemodynamics and blood sugar levels. Thirty-one children were admitted to the hospital to begin oral propranolol at a dose of 2 mg/kg/per day. Heart rate (HR), blood pressure (BP), and blood glucose (BG) measurements were obtained at baseline and 1 to 3 hours before and after each dose of propranolol. No caregivers reported any adverse effects during the hospitalization. On average, HR decreased by 5 beats per minute (bpm) (p < 0.01) and systolic BP decreased by 4 mmHg (p < 0.01) after propranolol administration. There was no statistically significant change in diastolic BP or BG with propranolol therapy. Over the first three doses of propranolol we saw statistically significant attenuation of the effects of propranolol on HR, with HR approaching baseline values during the hospitalization (p = 0.04). We did not see statistically significant changes in BP over the course of three doses of propranolol. This study suggests that 24-hour hospitalization with hemodynamic monitoring may not be necessary for safe initiation of propranolol therapy in otherwise healthy infants. Parental education on frequent feedings to decrease the chance of hypoglycemia may be as effective as 24-hour hospitalization.

Minimum clinically important difference in the Positive and Negative Syndrome Scale with data from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE).

CONTEXT: Establishing the minimum clinically important difference in the Positive and Negative Syndrome Scale (PANSS) is important to the interpretation of the research and clinical work conducted with this scale. METHOD: This study employed both anchor-based and distributive methods to estimate the minimum clinically important difference for the PANSS by using data from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial, a large, multicenter trial for patients with schizophrenia. By using an equipercentile method, data from 1,442 individuals linked PANSS scores with both clinician and patient ratings on the Clinical Global Impressions scale (CGI). Data were also used to investigate the magnitude of the standard error of measurement (SEM), offering another estimate of the minimum clinically important difference. RESULTS: Cross-sectional, clinician-rated CGI-Severity of illness scores of 1 through 7 linked to PANSS scores of 32.4, 42.2, 57.5, 74.5, 93.0, 110.9, and 131.0, respectively. The minimum clinically important difference for PANSS scores using this scale equaled a 15.3-point (34.0%) change from baseline. A 1.96 SEM on the PANSS corresponded to a 16.5-point (36.2%) change from baseline. The minimum clinically important difference for a subsample with above-median baseline PANSS scores was 38% higher than a sample with lower baseline scores. With the patient-rated CGI as the anchor, PANSS scores were higher for CGI scores of 1 through 4, and the minimum clinically important difference was lower, 11.2 points (24.6%). CONCLUSION: Minimum clinically important difference estimates from a longer-term effectiveness trial were consistent with previous efforts from shorter-term efficacy trials. Minimum clinically important difference estimates can help clinicians and researchers design future studies and interpret treatment change in future research and clinical work.