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Risk analysis tools can be applied in the early stages of the research, development, and innovation of pharmaceutical drugs. We used a risk ranking and filtering method to optimize time resources in internal audits of project development documents in order to ensure traceability in a university pilot plant. Data gathered during audits undertaken over a 14 month period were classified according to risk factors at several levels. Consequently, time resources for this type of internal audit can be optimised by focusing on aspects that are objectively determined to be critical to traceability. In addition, quality can be ensured by paying more attention to the most critical aspects, rather than the most commonly observed findings in historical data., Lay Abstract: One of the most important issue for a research, development, and innovation centre is the traceability of both experimental tasks and their documentation. This study describes an analysis of the findings revealed during internal audits carried out over a 14 month period, in order to establish its criticality and to highlight those important aspects to consider in future audits, while saving both personnel and time resources to carry out internal audits on development of projects.

Background: In the predictD-intervention, GPs used a personalised biopsychosocial programme to prevent depression. This reduced the incidence of major depression by 21.0%, although the results were not statistically significant.Aim: To determine whether the predictD-intervention is effective at preventing anxiety in primary care patients without depression or anxiety.Design and Setting: Secondary study of a cluster randomised trial with practices randomly assigned to either the predictD-intervention or usual care. This study was conducted in seven Spanish cities from October 2010 to July 2012.Method: In each city, 10 practices and two GPs per practice, as well as four to six patients every recruiting day, were randomly selected until there were 26-27 eligible patients for each GP. The endpoint was cumulative incidence of anxiety as measured by the PRIME-MD screening tool over 18 months.Results: A total of 3326 patients without depression and 140 GPs from 70 practices consented and were eligible to participate; 328 of these patients were removed because they had an anxiety syndrome at baseline. Of the 2998 valid patients, 2597 (86.6%) were evaluated at the end of the study. At 18 months, 10.4% (95% CI = 8.7% to 12.1%) of the patients in the predictD-intervention group developed anxiety compared with 13.1% (95% CI = 11.4% to 14.8%) in the usual-care group (absolute difference = -2.7% [95% CI = -5.1% to -0.3%]; P = 0.029).Conclusion: A personalised intervention delivered by GPs for the prevention of depression provided a modest but statistically significant reduction in the incidence of anxiety. [ABSTRACT FROM AUTHOR]

Background: Depression is viewed as a major and increasing public health issue, as it causes high distress in the people experiencing it and considerable financial costs to society. Efforts are being made to reduce this burden by preventing depression. A critical component of this strategy is the ability to assess the individual level and profile of risk for the development of major depression. This paper presents the cost-effectiveness of a personalized intervention based on the risk of developing depression carried out in primary care, compared with usual care.Methods: Cost-effectiveness analyses are nested within a multicentre, clustered, randomized controlled trial of a personalized intervention to prevent depression. The study was carried out in 70 primary care centres from seven cities in Spain. Two general practitioners (GPs) were randomly sampled from those prepared to participate in each centre (i.e. 140 GPs), and 3326 participants consented and were eligible to participate. The intervention included the GP communicating to the patient his/her individual risk for depression and personal risk factors and the construction by both GPs and patients of a psychosocial programme tailored to prevent depression. In addition, GPs carried out measures to activate and empower the patients, who also received a leaflet about preventing depression. GPs were trained in a 10- to 15-h workshop. Costs were measured from a societal and National Health care perspective. Qualityadjustedlife years were assessed using the EuroQOL five dimensions questionnaire. The time horizon was 18 months.Results: With a willingness-to-pay threshold of €10,000 (£8568) the probability of cost-effectiveness oscillated from 83% (societal perspective) to 89% (health perspective). If the threshold was increased to €30,000 (£25,704), the probability of being considered cost-effective was 94% (societal perspective) and 96%, respectively (health perspective). The sensitivity analysis confirmed these results.Conclusions: Compared with usual care, an intervention based on personal predictors of risk of depression implemented by GPs is a cost-effective strategy to prevent depression. This type of personalized intervention in primary care should be further developed and evaluated.Trial Registration: ClinicalTrials.gov, NCT01151982. Registered on June 29, 2010. [ABSTRACT FROM AUTHOR]

Importance: To our knowledge, no systematic reviews or meta-analyses have been conducted to assess the effectiveness of preventive psychological and/or educational interventions for anxiety in varied populations.Objective: To evaluate the effectiveness of preventive psychological and/or educational interventions for anxiety in varied population types.Data Sources: A systematic review and meta-analysis was conducted based on literature searches of MEDLINE, PsycINFO, Web of Science, EMBASE, OpenGrey, Cochrane Central Register of Controlled Trials, and other sources from inception to March 7, 2017.Study Selection: A search was performed of randomized clinical trials assessing the effectiveness of preventive psychological and/or educational interventions for anxiety in varying populations free of anxiety at baseline as measured using validated instruments. There was no setting or language restriction. Eligibility criteria assessment was conducted by 2 of us.Data Extraction and Synthesis: Data extraction and assessment of risk of bias (Cochrane Collaboration's tool) were performed by 2 of us. Pooled standardized mean differences (SMDs) were calculated using random-effect models. Heterogeneity was explored by random-effects meta-regression.Main Outcomes and Measures: Incidence of new cases of anxiety disorders or reduction of anxiety symptoms as measured by validated instruments.Results: Of the 3273 abstracts reviewed, 131 were selected for full-text review, and 29 met the inclusion criteria, representing 10 430 patients from 11 countries on 4 continents. Meta-analysis calculations were based on 36 comparisons. The pooled SMD was -0.31 (95% CI, -0.40 to -0.21; P < .001) and heterogeneity was substantial (I2 = 61.1%; 95% CI, 44% to 73%). There was evidence of publication bias, but the effect size barely varied after adjustment (SMD, -0.27; 95% CI, -0.37 to -0.17; P < .001). Sensitivity analyses confirmed the robustness of effect size results. A meta-regression including 5 variables explained 99.6% of between-study variability, revealing an association between higher SMD, waiting list (comparator) (β = -0.33 [95% CI, -0.55 to -0.11]; P = .005) and a lower sample size (lg) (β = 0.15 [95% CI, 0.06 to 0.23]; P = .001). No association was observed with risk of bias, family physician providing intervention, and use of standardized interviews as outcomes.Conclusions and Relevance: Psychological and/or educational interventions had a small but statistically significant benefit for anxiety prevention in all populations evaluated. Although more studies with larger samples and active comparators are needed, these findings suggest that anxiety prevention programs should be further developed and implemented. [ABSTRACT FROM AUTHOR]

Background: Not enough is known about universal prevention of depression in adults.Objective: To evaluate the effectiveness of an intervention to prevent major depression.Design: Multicenter, cluster randomized trial with sites randomly assigned to usual care or an intervention. (ClinicalTrials.gov: NCT01151982).Setting: 10 primary care centers in each of 7 cities in Spain.Participants: Two primary care physicians (PCPs) and 5236 nondepressed adult patients were randomly sampled from each center; 3326 patients consented and were eligible to participate.Intervention: For each patient, PCPs communicated individual risk for depression and personal predictors of risk and developed a psychosocial program tailored to prevent depression.Measurements: New cases of major depression, assessed every 6 months for 18 months.Results: At 18 months, 7.39% of patients in the intervention group (95% CI, 5.85% to 8.95%) developed major depression compared with 9.40% in the control (usual care) group (CI, 7.89% to 10.92%) (absolute difference, -2.01 percentage points [CI, -4.18 to 0.16 percentage points]; P = 0.070). Depression incidence was lower in the intervention centers in 5 cities and similar between intervention and control centers in 2 cities.Limitation: Potential self-selection bias due to nonconsenting patients.Conclusion: Compared with usual care, an intervention based on personal predictors of risk for depression implemented by PCPs provided a modest but nonsignificant reduction in the incidence of major depression. Additional study of this approach may be warranted.Primary Funding Source: Institute of Health Carlos III. [ABSTRACT FROM AUTHOR]

Purpose Psychometric properties of the Psychosocial Assessment Tool 2.0 (PAT2.0), a brief screener for psychosocial risk in families of children with cancer, are presented. Methods Female (N = 132) and male (N = 72) caregivers of 141 children newly diagnosed with cancer completed the PAT2.0 and measures of child behavior symptoms, anxiety, acute stress, and family functioning to establish validity. Internal consistency and test-retest reliability of the PAT2.0 were also examined. Results Internal consistency and two-week test- retest for the PAT2.0 Total score was strong. Validity for the PAT2.0 was supported by significant correlations between the PAT2.0 subscales and measures of corresponding constructs. PAT2.0 Total scores were correlated with acute stress and child behavior symptoms for both mothers and fathers. Receiver-Operating Characteristic curves provided preliminary support for the proposed cutoffs. Conclusion The PAT2.0 Total score is a useful screening tool for family psychosocial risk in the pediatric oncology population. [ABSTRACT FROM AUTHOR]