Assessment of the quality of sample labelling for clinical research

Objective: To assess the quality of the labels for clinical trial samples through current regulations, and to analyze its potential correlation with the specific characteristics of each sample. Method: A transversal multicenter study where the clinical trial samples from two third level hospitals were analyzed. The eleven items from Directive 2003/94/EC, as well as the name of the clinical trial and the dose on the label cover, were considered variables for labelling quality. The influence of the characteristics of each sample on labelling quality was also analyzed. Outcome: The study included 503 samples from 220 clinical trials. The mean quality of labelling, understood as the proportion of items from Appendix 13, was of 91.9%. Out of these, 6.6% did not include the name of the sample in the outer face of the label, while in 9.7% the dose was missing. The samples with clinical trial-type samples presented a higher quality (p < 0.049), blinding reduced their quality (p = 0.017), and identification by kit number or by patient increased it (p < 0.01). The promoter was the variable which introduced the highest variability into the analysis. Conclusions: The mean quality of labelling is adequate in the majority of clinical trial samples. The lack of essential information in some samples, such as the clinical trial code and the period of validity, is alarming and might be the potential source for dispensing or administration errors.

Quality of implementation in evidence-based positive parenting programs in Spain: Introduction to the special issue

The main contribution of this special issue is to present evaluation studies involving large-scale experiences of implementation of positive parenting programs delivered through home, group-based, and on-line formats in Spain. Two research questions were addressed: (1) what factors affect implementation; and (2) for whom and under which implementation conditions the programs lead to positive outcomes. Target populations were mainly families from low and middle socioeconomic backgrounds, and parents at psychosocial risk attending family support services in need of improving their parenting skills. All the programs fall under the umbrella of the positive parenting initiative launched by the Council of Europe, are evidence-based, follow a collaborative schema with national, regional, or local authorities, have multi-site implementation, and are supported by highly experienced researchers from Spanish universities. Special attention is given to the program adaptations to different contexts, the profile of parents who benefited most from the programs, analyses of the implementation process, and the assessment of parenting programs in the community. The information provided will help to increase our knowledge of evidence-based parenting programs in Spain, their implementation processes and results, and the future challenges that need to be addressed to continue the current expansion of evidence-based parenting programs.