Adaptation, Content Validity and Reliability of the Autism Classification System of Functioning for Social Communication: From Toddlerhood to Adolescent-Aged Children with Autism.

The Autism Classification System of Functioning: Social Communication (ACSF) describes social communication functioning levels. First developed for preschoolers with ASD, this study tests an expanded age range (2-to-18 years). The ACFS rates the child's typical and best (i.e., capacity) performance. Qualitative methods tested parent and clinician perspectives of the ACSF age expansion using content analysis. The ACSF was used twice by parents and professionals for the same child/youth. Reliabilities were assessed using weighted kappa. Content validity supported the ACSF's applicability, clarity, and usability. The ACSF adaptations did not change its original construct. Reliability were calculated from 90 parent and professional Time-1 and Time-2 ratings for children/youth (2.1-15.6 years). Results showed good-to-very good intra-rater agreement (typical) and good inter-rater agreement (capacity).

Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience.

BACKGROUND: Surgeons in the Netherlands, Canada and the US participate in the FAITH trial (Fixation using Alternative Implants for the Treatment of Hip fractures). Dutch sites are managed and visited by a financed central trial coordinator, whereas most Canadian and US sites have local study coordinators and receive per patient payment. This study was aimed to assess how these different trial management strategies affected trial performance. METHODS: Details related to obtaining ethics approval, time to trial start-up, inclusion, and percentage completed follow-ups were collected for each trial site and compared. Pre-trial screening data were compared with actual inclusion rates. RESULTS: Median trial start-up ranged from 41 days (P25-P75 10-139) in the Netherlands to 232 days (P25-P75 98-423) in Canada (p = 0.027). The inclusion rate was highest in the Netherlands; median 1.03 patients (P25-P75 0.43-2.21) per site per month, representing 34.4% of the total eligible population. It was lowest in Canada; 0.14 inclusions (P25-P75 0.00-0.28), representing 3.9% of eligible patients (p < 0.001). The percentage completed follow-ups was 83% for Canadian and Dutch sites and 70% for US sites (p = 0.217). CONCLUSIONS: In this trial, a central financed trial coordinator to manage all trial related tasks in participating sites resulted in better trial progression and a similar follow-up. It is therefore a suitable alternative for appointing these tasks to local research assistants. The central coordinator approach can enable smaller regional hospitals to participate in multicenter randomized controlled trials. Circumstances such as available budget, sample size, and geographical area should however be taken into account when choosing a management strategy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00761813.

Evidence-based orthopaedics: is it possible?

EBM is referred to as the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. This article describes the history and practice of evidence-based medicine.