Structured frameworks to increase the transparency of the assessment of benefits and risks of medicines: current status and possible future directions

Structured frameworks for benefit-risk analysis in drug licensing decisions are being implemented across a number of regulatory agencies worldwide. The aim of these frameworks is to aid the analysis and communication of the benefit-risk assessment throughout the development, evaluation, and supervision of medicines. In this review, authors from regulatory agencies, pharmaceutical companies, and academia share their views on the different frameworks and discuss future directions

A survey of relationship between anxiety, depression and duration of infertility

BACKGROUND: A cross sectional study was designed to survey the relationship between anxiety/depression and duration/cause of infertility, in Vali-e-Asr Reproductive Health Research Center, Tehran, Iran. METHODS: After obtaining their consents, 370 female patients with different infertility causes participated in, and data gathered by Beck Depression Inventory(BDI) and Cattle questionnaires for surveying anxiety and depression due to the duration of infertility. This was studied in relation to patients' age, educational level, socio-economic status and job (patients and their husbands). RESULTS: Age range was 17–45 years and duration and cause of infertility was 1–20 years. This survey showed that 151 women (40.8%) had depression and 321 women (86.8%) had anxiety. Depression had a significant relation with cause of infertility, duration of infertility, educational level, and job of women. Anxiety had a significant relationship with duration of infertility and educational level, but not with cause of infertility, or job. Findings showed that anxiety and depression were most common after 4–6 years of infertility and especially severe depression could be found in those who had infertility for 7–9 years. CONCLUSIONS: Adequate attention to these patients psychologically and treating them properly, is of great importance for their mental health and will improve quality of their lives

Towards a data publishing framework for primary biodiversity data: challenges and potentials for the biodiversity informatics community

Background: Currently primary scientific data, especially that dealing with biodiversity, is neither easily discoverable nor accessible. Amongst several impediments, one is a lack of professional recognition of scientific data publishing efforts. A possible solution is establishment of a ‘Data Publishing Framework’ which would encourage and recognise investments and efforts by institutions and individuals towards management, and publishing of primary scientific data potentially on a par with recognitions received for scholarly publications. Discussion: This paper reviews the state-of-the-art of primary biodiversity data publishing, and conceptualises a ‘Data Publishing Framework’ that would help incentivise efforts and investments by institutions and individuals in facilitating free and open access to biodiversity data. It further postulates the institutionalisation of a ‘Data Usage Index (DUI)’, that would attribute due recognition to multiple players in the data collection/creation, management and publishing cycle. Conclusion: We believe that institutionalisation of such a ‘Data Publishing Framework’ that offers socio-cultural, legal, technical, economic and policy environment conducive for data publishing will facilitate expedited discovery and mobilisation of an exponential increase in quantity of ‘fit-for-use’ primary biodiversity data, much of which is currently invisible

Errorful and errorless learning: The impact of cue–target constraint in learning from errors

The benefits of testing on learning are well described, and attention has recently turned to what happens when errors are elicited during learning: Is testing nonetheless beneficial, or can errors hinder learning? Whilst recent findings have indicated that tests boost learning even if errors are made on every trial, other reports, emphasizing the benefits of errorless learning, have indicated that errors lead to poorer later memory performance. The possibility that this discrepancy is a function of the materials that must be learned-in particular, the relationship between the cues and targets-was addressed here. Cued recall after either a study-only errorless condition or an errorful learning condition was contrasted across cue-target associations, for which the extent to which the target was constrained by the cue was either high or low. Experiment 1 showed that whereas errorful learning led to greater recall for low-constraint stimuli, it led to a significant decrease in recall for high-constraint stimuli. This interaction is thought to reflect the extent to which retrieval is constrained by the cue-target association, as well as by the presence of preexisting semantic associations. The advantage of errorful retrieval for low-constraint stimuli was replicated in Experiment 2, and the interaction with stimulus type was replicated in Experiment 3, even when guesses were randomly designated as being either correct or incorrect. This pattern provides support for inferences derived from reports in which participants made errors on all learning trials, whilst highlighting the impact of material characteristics on the benefits and disadvantages that accrue from errorful learning in episodic memory

Consumer Perceptions of Integrated Trauma-Informed Services among Women with Co-Occurring Disorders

As part of a national, multi-site treatment outcome study, an instrument was designed to assess consumers’ perceptions of key services integrating trauma, mental health, and substance abuse issues, the Consumer Perceptions of Care (CPC). This study evaluates the psychometric properties of this instrument and analyzes consumers’ perceptions of the services they received. The results suggest that the measure has four factors: services integration, choice in services, trauma-informed assessment, and respect for cultural identity. These factors demonstrated adequate reliability, and the overall results suggested that the measure is a reliable, sensitive, and valid reflection of consumers’ perceptions of their services and their providers for diverse racial and ethnic groups. Women in the intervention programs perceived their services as more highly integrated for trauma, mental health, and substance use than women in the services as usual or comparison programs, supporting its utility as a measure of programs designed to provide integrated services