A Phase 3, Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Trial Investigating the Efficacy and Safety of Clobetasol Propionate Cream, 0.025% in the Treatment of Moderate to Severe Plaque Psoriasis for 14 Days

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Progress feedback in children and adolescents with internalizing and externalizing symptoms in routine care (OPTIE study): study protocol of a randomized parallel-group trial

Background Progress feedback provides therapists with progress notes on a regular basis through the continuous assessment of participants throughout their treatment (e.g., symptoms, therapeutic alliance). While for adults the evidence base has increased over the years, progress feedback in the therapy of children and adolescents has not been sufficiently investigated. This manuscript describes the trial protocol of the OPTIE study: a randomized trial that tests the efficacy of a progress feedback system in children and adolescents under conditions of routine care. Methods The study is based on a randomized parallel-group trial with two treatment groups (routine, feedback) at an outpatient unit of a university hospital. The target sample size is 439 families consisting of children and adolescents aged 6 to17 years old with internalizing and/or externalizing symptoms. Both the patients and the therapists are independently assigned to the treatment groups by stratified block randomization. In both treatment groups patients receive routine care behavioral therapy for a study-related 12 months; additionally, in the feedback group, a progress feedback system with three components is applied (monitoring, report, and supervision). For three informants (caregiver, child [≥ 11 years], therapist) surveys are conducted every 6 weeks (e.g., symptoms, goals, motivation). For both treatment groups, comparison data is collected at baseline and at six and 12 months after the beginning of the intervention (pre, inter, post), and includes five informants (blinded clinician, therapist, caregiver, child [≥ 11 years], teacher). Discussion The OPTIE study will contribute to the evidence base of progress feedback in children and adolescents and has the potential to uncover treatments’ effects in the small to medium range. Noteworthy features are the inclusion of children younger than 10 years old and the consideration of a blinded clinician rating. Trial registration German Clinical Trials Register (DRKS) DRKS00016737 (https://www.drks.de/DRKS00016737). Registered 17 September, 2019.

Coffee break has no impact on laparoscopic skills: a randomized double-blinded placebo-controlled parallel-group trial

Background Coffee is a widely consumed beverage. Surgeons often drink coffee before performing surgery. Caffeine intake leads to tremor which might have a negative effect on surgeons’ fine motor skills. Methods A double-blinded parallel-group trial was conducted in order to investigate if caffeinated coffee intake has a negative effect on laparoscopic skills and increases tremor, regardless of previous coffee consumption. 118 participants were selected during a congress of the German Society of Surgery. Exclusion criteria were immaturity and no given consent. Participants and investigators were blinded. Participants were randomized with a 1:1 allocation into interventional group receiving caffeinated coffee or placebo group receiving decaffeinated coffee. The motor skills were tested with two validated laparoscopic exercises at a laparoscopy simulator (LapSim®) before and 30 min after coffee intake. Data on influencing factors were recorded in a standardized questionnaire and tested for equal distribution in both groups. In both exercises four parameters were recorded: left and right hand path length and angular path. Their differences and the resulting effect scores were calculated for both groups as primary outcome to test which group showed greater improvement on the second round of exercises. Registration number DRKS00023608, registered retrospectively. Results Fifty nine subjects were assigned to each the interventional (54 analyzed) and placebo group (53 analyzed) with 11 drop outs. There was no significant difference between the placebo and interventional group in the two exercises in effect score 30 min after coffee intake [mean (SD); 38.58 (10.66) vs. 41.73 (7.40) and 113.09 (28.94) vs. 116.59 (25.63)]. A significant improvement from first to second measurement in the first exercise could be observed for both groups, demonstrating the training effect. Conclusion In our study, we verified that additional caffeinated coffee intake, e.g., during a coffee break, does not lead to deterioration of laparoscopic fine motor skills.