A Prospective, Observational Registry Study to Evaluate Effectiveness and Safety of Hyaluronic Acid-Based Dermal Fillers in Routine Practice: Interim Analysis Results with One Year of Subject Follow-Up.

BACKGROUND: Monitoring the effectiveness, safety and emerging uses of hyaluronic acid (HA) fillers in their wide range of indications requires a holistic approach. PURPOSE: To propose an observational study design aiming to gather real-world evidence (RWE) and continuously evaluate the performance and safety of marketed devices in routine practice. MATERIALS AND METHODS: A prospective, observational registry was initiated at six European sites. Investigators enrolled any subject receiving at least one injection with a target study device (TEOSYAL Deep Lines [HADL] and/or Global Action [HAGA]). They followed their routine practice regarding injection technique, volume, and subject follow-up. Effectiveness was evaluated at 3 months using the global aesthetic improvement scale (GAIS). Safety was assessed based on common treatment reactions (CTR) and adverse events (AE). RESULTS: High quantity of RWE was collected following the initiation of this registry. In the first 158 subjects enrolled, 1220 injections were performed in more than 25 indications, including 679 with the target devices and 271 with devices of the same filler line. The primary objective was achieved, with 93.9% of treatments providing improvement at Month 3 according to the PI and subject. Post-injection CTR were mild to moderate and short-lived, and there was no clinically significant AE. More than 76% of treatments still provided some visible effect at month 12. CONCLUSION: Based on RWE, HADL and HAGL are effective and safe in their respective indications mostly distributed in the midface, perioral region, and lower face. Observational registries are a valuable asset in the context of post-market clinical follow-up.

No Medication for My Child! A Naturalistic Study on the Treatment Preferences for and Effects of Cogmed Working Memory Training Versus Psychostimulant Medication in Clinically Referred Youth with ADHD.

In this naturalistic clinical study, we explored the applicability and clinical effectiveness of Cogmed WMT, pharmacotherapy, and their combination for clinically referred children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Ninety youth with ADHD (ages 6-16 years) and their parents were offered the possibility to choose one of the three interventions. The motives for choosing various interventions were quite different. Medication was chosen because this treatment was expected to be most effective, but also because the Cogmed WMT program was regarded as too taxing. The choice for Cogmed WMT was mainly negatively motivated: participants tended to be strongly against the use of medication, found it a too rigorous step, or feared side effects and addiction problems. The choice for the combination treatment was strongly positively motivated: parents and youth indicated that they wanted to receive the best possible intervention and part of them also had high expectations of Cogmed WMT. In terms of clinical effectiveness, pharmacotherapy with stimulant medication and the combination treatment produced larger reductions in ADHD symptomatology than Cogmed WMT. Further, results indicated that Cogmed WMT selectively enhanced working memory performance. Finally, after conducting Cogmed WMT, youths and parents were more 'open' to accept pharmacotherapy as intervention, probably because the training increased greater insight in and awareness of the problematic features of ADHD.

Being on Your Own or Feeling Lonely? Loneliness and Other Social Variables in Youths with Autism Spectrum Disorders.

A cross-sectional study was conducted to examine loneliness and its correlates in children (7 to 11 years) and adolescents (12 to 18 years) with autism spectrum disorders (ASD, n = 73) and control groups of clinically referred (ADHD, n = 76) and non-clinical (n = 106) youths. Youths completed questionnaires on loneliness and desire for social interaction, while parents and teachers filled out scales on other aspects of children's social functioning. Results indicated that only at an adolescent age, the ASD group reported higher levels of loneliness than the control groups. Further, the ASD group generally expressed relatively low levels of desire for social interaction, although these youths displayed a similar increase in the wish to belong during adolescence as participants in the control groups. Finally, the ASD group exhibited lower levels of social competence and social skills and higher levels of social problems and social anxiety than the control groups, and in all groups these social variables correlated in a theoretically meaningful with loneliness.

A Group-Administered social Skills Training for 8- to 12- Year-Old, high-Functioning Children With Autism Spectrum Disorders: An Evaluation of its Effectiveness in a Naturalistic Outpatient Treatment Setting.

A social skills training (SST) for high-functioning children with autism spectrum disorders (ASD) was evaluated in an outpatient setting using a combined between- and within-subject design in which SST and a waiting list condition were compared. According to parents and teachers, the SST produced greater improvement of social skills than the waiting list, and these effects were maintained at 3 months follow-up. No between-group effects were found for loneliness, although in general scores on this outcome measure decreased from pre- to follow-up. The effects of SST were unaffected by social anxiety, ADHD symptoms, Theory of Mind, or desire for social interaction. Altogether, SST seems an effective intervention for high-functioning children with ASD that can be applied in daily clinical practice.