2,170 research outputs found

    Scientific Opinion on the re-evaluation of Quinoline Yellow (E 104) as a food additive:Question No EFSA-Q-2008-223

    Get PDF
    The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Quinoline Yellow (E 104). Quinoline Yellow has been previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1975, 1978 and 1984, and the EU Scientific Committee for Food (SCF) in 1984. Both committees established an Acceptable Daily Intake (ADI) of 0-10 mg/kg body weight (bw). Studies not evaluated by JECFA and the SCF included a chronic toxicity and carcinogenicity study with a reproductive toxicity phase in rats and a study on behaviour in children by McCann et al. from 2007. The latter study concluded that exposure to a mixture of colours including Quinoline Yellow resulted in increased hyperactivity in 8- to 9-years old children. The Panel concurs with the conclusion from a previous EFSA opinion on the McCann et al. study that the findings of the study cannot be used as a basis for altering the ADI. The Panel notes that Quinoline Yellow was negative in in vitro genotoxicity as well as in long term carcinogenicity studies. The Panel concludes that the currently available database on semi-chronic, reproductive, developmental and long-term toxicity of Quinoline Yellow, including a study in rats not apparently taken into consideration by JECFA or the SCF, provides a rationale for re-definition of the ADI. Using the NOAEL of 50 mg/kg bw/day provided by the chronic toxicity and carcinogenicity study with a reproductive toxicity phase carried out in rats and applying an uncertainty factor of 100 to this NOAEL, the Panel establishes an ADI of 0.5 mg/kg bw/day. The Panel notes that at the maximum levels of use of Quinoline Yellow, refined intake estimates are generally well over the ADI of 0.5 mg/kg bw/day

    The changing nature of labour regulation: the distinctiveness of the National Agreement for the Engineering Construction Industry

    Get PDF
    The article addresses the changing nature of labour regulation through analysis of the National Agreement for the Engineering Construction Industry, originating in 1981. It shows how multiple spatial regulatory scales, the changing coalitions of actors involved, employer and client engagement and labour agency have been critical to National Agreement for the Engineering Construction Industry's survival

    The Men's Safer Sex (MenSS) trial: protocol for a pilot randomised controlled trial of an interactive digital intervention to increase condom use in men

    Get PDF
    Sexually transmitted infections (STI) are a major public health problem. Condoms provide effective protection but there are many barriers to use. Face-to-face health promotion interventions are resource-intensive and show mixed results. Interactive digital interventions may provide a suitable alternative, allowing private access to personally tailored behaviour change support. We have developed an interactive digital intervention (the Men's Safer Sex (MenSS) website) which aims to increase condom use in men. We describe the protocol for a pilot trial to assess the feasibility of a full-scale randomised controlled trial of the MenSS website in addition to usual sexual health clinical care

    The second Randomised Evaluation of the Effectiveness, cost-effectiveness and Acceptability of Computerised Therapy (REEACT-2) trial: does the provision of telephone support enhance the effectiveness of computer-delivered cognitive behaviour therapy? A randomised controlled trial.

    Get PDF
    BACKGROUND: Computerised cognitive behaviour therapy (cCBT) is an efficient form of therapy potentially improving access to psychological care. Indirect evidence suggests that the uptake and effectiveness of cCBT can be increased if facilitated by telephone, but this is not routinely offered in the NHS. OBJECTIVES: To compare the clinical effectiveness and cost-effectiveness of telephone-facilitated free-to-use cCBT [e.g. MoodGYM (National Institute for Mental Health Research, Australian National University, Canberra, ACT, Australia)] with minimally supported cCBT. DESIGN: This study was a multisite, pragmatic, open, two-arm, parallel-group randomised controlled trial with a concurrent economic evaluation. SETTING: Participants were recruited from GP practices in Bristol, Manchester, Sheffield, Hull and the north-east of England. PARTICIPANTS: Potential participants were eligible to participate in the trial if they were adults with depression scoring ≥ 10 on the Patient Health Questionnaire-9 (PHQ-9). INTERVENTIONS: Participants were randomised using a computer-generated random number sequence to receive minimally supported cCBT or telephone-facilitated cCBT. Participants continued with usual general practitioner care. MAIN OUTCOME MEASURES: The primary outcome was self-reported symptoms of depression, as assessed by the PHQ-9 at 4 months post randomisation. SECONDARY OUTCOMES: Secondary outcomes were depression at 12 months and anxiety, somatoform complaints, health utility (as assessed by the European Quality of Life-5 Dimensions questionnaire) and resource use at 4 and 12 months. RESULTS: Clinical effectiveness: 182 participants were randomised to minimally supported cCBT and 187 participants to telephone-facilitated cCBT. There was a difference in the severity of depression at 4 and 12 months, with lower levels in the telephone-facilitated group. The odds of no longer being depressed (defined as a PHQ-9 score of < 10) at 4 months were twice as high in the telephone-facilitated cCBT group [odds ratio (OR) 2.05, 95% confidence interval (CI) 1.23 to 3.42]. The benefit of telephone-facilitated cCBT was no longer significant at 12 months (OR 1.63, 95% CI 0.98 to 2.71). At 4 months the between-group difference in PHQ-9 scores was 1.9 (95% CI 0.5 to 3.3). At 12 months the results still favoured telephone-facilitated cCBT but were no longer statistically significant, with a difference in PHQ-9 score of 0.9 (95% CI -0.5 to 2.3). When considering the whole follow-up period, telephone-facilitated cCBT was asssociated with significantly lower PHQ-9 scores than minimally supported cCBT (mean difference -1.41, 95% CI -2.63 to -0.17; p = 0.025). There was a significant improvement in anxiety scores over the trial period (between-group difference 1.1, 95% CI 0.1 to 2.3; p = 0.037). In the case of somatic complaints (assessed using the Patient Health Questionnaire-15), there was a borderline statistically significant difference over the trial period (between-group difference 1.1, 95% CI 0.0 to 1.8; p = 0.051). There were gains in quality-adjusted life-years at reduced cost when telephone facilitation was added to MoodGYM. However, the results were subject to uncertainty. CONCLUSIONS: The results showed short-term benefits from the addition of telephone facilitation to cCBT. The effect was small to moderate and comparable with that of other primary care psychological interventions. Telephone facilitation should be considered when offering cCBT for depression. LIMITATIONS: Participants' depression was assessed with the PHQ-9, cCBT use was quite low and there was a slightly greater than anticipated loss to follow-up. FUTURE RESEARCH RECOMMENDATIONS: Improve the acceptability of cCBT and its capacity to address coexisting disorders. Large-scale pragmatic trials of cCBT with bibliotherapy and telephone-based interventions are required. TRIAL REGISTRATION: Current Controlled Trials ISRCTN55310481. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 89. See the NIHR Journals Library website for further project information
    • …
    corecore