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 an evidence-based family prevention program: the Family Competence Program

Family prevention programs need to be evidence-based in order to guarantee the success of their implementation. The Family Competence Program (FCP), a Spanish cultural adaptation of the Strengthening Families Program (SFP), has developed different measures and processes to gauge the quality of the implementation. This article is dedicated specifically to two of these measures: the evaluation of the facilitators and the assessment of the family engagement techniques. For evaluating the facilitators, a Delphi technique with experts and professionals is undertaken. For assessing the family techniques, both self-evaluation of trainers and evaluation by families are used. Finding underpin that, in the case of facilitators, is important that, after to skills and experience, they need to understand the theory of change of the program. In the case of family engagement techniques, more detailed, comprehensive talks, discussions and group activities lead to better family engagement outcomes.

Home and group-based implementation of the "Growing Up Happily in the Family" program in at-risk psychosocial contexts

"Growing Up Happily in the Family" is a program to prevent child maltreatment targeted at parents of children aged 0-5 years old in at-risk psychosocial contexts. The program is delivered via either a group-based or a home-visit format. The objective of this study was to evaluate the impact of various implementation components in the home and group versions on changes in parental attitudes about child development and education. At-risk and non at-risk parents participated in the group-based (196 participants in 26 groups) and home-visit (95 participants) versions of the program delivered through local social services. We analyzed program adherence, adaptations, participant responsiveness, quality of delivery, and implementation barriers as predictors of changes in parental attitudes. The results showed that greater program adherence, better quality of delivery and participant responsiveness, and positive climate predicted changes in parental attitudes in both formats. Therefore, it is important to take into account the quality of the implementation process when testing the effectiveness of early group-based and home-visit interventions in at-risk families.

Assessment of positive parenting programmes in the Autonomous Region of the Basque Country (Spain)

This paper presents the results of a study aimed at identifying and assessing positive parenting programmes and activities carried out in the Autonomous Region of the Basque Country (ARBC), Spain. The study is a development of the III Inter-institutional Family Support Plan (2011), drafted by the Basque Government's Department of Family Policy and Community Development, and its aim is to offer a series of sound criteria for improving existing programmes and ensuring the correct design and implementation of new ones in the future. It analyses 129 programmes and gathers data relative to institutional management and coordination, format, quality of the established aims, adaptation to the theoretical proposal for an Optimal Positive Parenting Curriculum, scientific base, use of the framework of reference for competences, working method, assessment techniques, budgets and publicity, among others. The results highlight the good quality of the programmes' aims and content, and the poor systematic assessment of these same aspects. The study concludes with a series of recommendations for improving the initiatives, integrated into a proposal for a system of indicators to assess and implement positive parenting programmes.