Consent to research participation: understanding and motivation among German pupils

Background The EU's 2006 Paediatric Regulation aims to support authorisation of medicine for children, thus effectively increasing paediatric research. It is ethically imperative to simultaneously establish procedures that protect children's rights. Method This study endeavours (a) to evaluate whether a template consent form designed by the Standing Working Group of the German-Research-Ethics-Committees (AKEK) adequately informs adolescents about research participation, and (b) to investigate associated phenomena like therapeutic misconception and motives for research participation. In March 2016 a questionnaire study was conducted among 279 pupils (mean age 13.1 years) of a secondary school in northern Germany. Results A majority of participants showed a general good understanding of foundational research ethics concepts as understood from the AKEK consent form. Nevertheless, our data also suggests possible susceptibility to therapeutic misconception. Own health concerns and pro-social considerations were found to be significant motivational factors for participating in research, while anticipation of pain lessens likelihood of participation. Advice from trusted others is an important decisional influence, too. Furthermore, data security was found to be a relevant aspect of adolescents' decision-making process. Conclusion Bearing in mind adolescents' generally good understanding, we infer the lack of knowledge about medical research in general to be one source of therapeutic misconception. To further improve the quality of consent we propose a multi-staged approach whereby general research education is completed before an individual becomes a patient or potential participant. To the best of our knowledge this is the first German questionnaire-study addressing issues of informed consent in a large under-age sample

Interventions for hyperhidrosis in secondary care : a systematic review and value-of-information analysis

Background: Hyperhidrosis is uncontrollable excessive sweating that occurs at rest, regardless of temperature. The symptoms of hyperhidrosis can significantly affect quality of life. The management of hyperhidrosis is uncertain and variable. Objective: To establish the expected value of undertaking additional research to determine the most effective interventions for the management of refractory primary hyperhidrosis in secondary care. Methods: A systematic review and economic model, including a value-of-information (VOI) analysis. Treatments to be prescribed by dermatologists and minor surgical treatments for hyperhidrosis of the hands, feet and axillae were reviewed; as endoscopic thoracic sympathectomy (ETS) is incontestably an end-of-line treatment, it was not reviewed further. Fifteen databases (e.g. CENTRAL, PubMed and PsycINFO), conference proceedings and trial registers were searched from inception to July 2016. Systematic review methods were followed. Pairwise meta-analyses were conducted for comparisons between botulinum toxin (BTX) injections and placebo for axillary hyperhidrosis, but otherwise, owing to evidence limitations, data were synthesised narratively. A decision-analytic model assessed the cost-effectiveness and VOI of five treatments (iontophoresis, medication, BTX, curettage, ETS) in 64 different sequences for axillary hyperhidrosis only. Results and conclusions: Fifty studies were included in the effectiveness review: 32 randomised controlled trials (RCTs), 17 non-RCTs and one large prospective case series. Most studies were small, rated as having a high risk of bias and poorly reported. The interventions assessed in the review were iontophoresis, BTX, anticholinergic medications, curettage and newer energy-based technologies that damage the sweat gland (e.g. laser, microwave). There is moderate-quality evidence of a large statistically significant effect of BTX on axillary hyperhidrosis symptoms, compared with placebo. There was weak but consistent evidence for iontophoresis for palmar hyperhidrosis. Evidence for other interventions was of low or very low quality. For axillary hyperhidrosis cost-effectiveness results indicated that iontophoresis, BTX, medication, curettage and ETS was the most cost-effective sequence (probability 0.8), with an incremental cost-effectiveness ratio of £9304 per quality-adjusted life-year. Uncertainty associated with study bias was not reflected in the economic results. Patients and clinicians attending an end-of-project workshop were satisfied with the sequence of treatments for axillary hyperhidrosis identified as being cost-effective. All patient advisors considered that the Hyperhidrosis Quality of Life Index was superior to other tools commonly used in hyperhidrosis research for assessing quality of life. Limitations: The evidence for the clinical effectiveness and safety of second-line treatments for primary hyperhidrosis is limited. This meant that there was insufficient evidence to draw conclusions for most interventions assessed and the cost-effectiveness analysis was restricted to hyperhidrosis of the axilla. Future work: Based on anecdotal evidence and inference from evidence for the axillae, participants agreed that a trial of BTX (with anaesthesia) compared with iontophoresis for palmar hyperhidrosis would be most useful. The VOI analysis indicates that further research into the effectiveness of existing medications might be worthwhile, but it is unclear that such trials are of clinical importance. Research that established a robust estimate of the annual incidence of axillary hyperhidrosis in the UK population would reduce the uncertainty in future VOI analyses

Analysis of Social Support as an Argument for the Sustainable Construction of the European Community Space

Cohesion policy is a constant and central area of interest across the European Union. The development and success of European society depends on the social and economic cohesion at the level of all member states. Starting from this assumption, our study will focus on the interdependence between social cohesion and social support, the latter being interpreted and analysed as a means whereby social cohesion may be achieved. Thus, understanding the manifestations of community cohesion at the level of the European communities is an essential element in this investigation, while its main purpose is to build an explanatory model for interpreting social support. Based on such a framework, social cohesion may be analysed and understood. The following measurement scales will be applied to the analysis of social support: the Multidimensional Scale of Perceived Social Support, the Survey of Recent Life Experiences, and the Satisfaction with Life Scale. The source of the information is a non-random sample of 1364 respondents. Data processing is based on the implementation of structural equation modelling (SEM) in order to explore the key factors that influence the perception of social support. As mentioned previously, we plan to build an explanatory model that links the perception of social support with life satisfaction and the disturbing factors that are the outcome of life experiences. A set of comparisons is also made using the independent t test and one-way ANOVA. The perception of social support is interpreted from the perspective of the occupational situation, the age category, the educational level and the marital status of respondents. The variables included in the study generally satisfied the goodness of fit indexes in accordance with the recommendations of the literature on SEM models. The conclusions of the study show that social support is at the core of community integration and one of the determinant elements of social cohesion. Everyday life events condition the perception of social support. In turn, the perception of social support acts on life satisfaction. It has been observed that a higher perception of social support may be associated with greater cohesion at the level of communities and also with a more stable social environment. We have identified a determining relationship between the perceived social support and the degree of social cohesion

Analysis of Social Support as an Argument for the Sustainable Construction of the European Community Space

Cohesion policy is a constant and central area of interest across the European Union. The development and success of European society depends on the social and economic cohesion at the level of all member states. Starting from this assumption, our study will focus on the interdependence between social cohesion and social support, the latter being interpreted and analysed as a means whereby social cohesion may be achieved. Thus, understanding the manifestations of community cohesion at the level of the European communities is an essential element in this investigation, while its main purpose is to build an explanatory model for interpreting social support. Based on such a framework, social cohesion may be analysed and understood. The following measurement scales will be applied to the analysis of social support: the Multidimensional Scale of Perceived Social Support, the Survey of Recent Life Experiences, and the Satisfaction with Life Scale. The source of the information is a non-random sample of 1364 respondents. Data processing is based on the implementation of structural equation modelling (SEM) in order to explore the key factors that influence the perception of social support. As mentioned previously, we plan to build an explanatory model that links the perception of social support with life satisfaction and the disturbing factors that are the outcome of life experiences. A set of comparisons is also made using the independent t test and one-way ANOVA. The perception of social support is interpreted from the perspective of the occupational situation, the age category, the educational level and the marital status of respondents. The variables included in the study generally satisfied the goodness of fit indexes in accordance with the recommendations of the literature on SEM models. The conclusions of the study show that social support is at the core of community integration and one of the determinant elements of social cohesion. Everyday life events condition the perception of social support. In turn, the perception of social support acts on life satisfaction. It has been observed that a higher perception of social support may be associated with greater cohesion at the level of communities and also with a more stable social environment. We have identified a determining relationship between the perceived social support and the degree of social cohesion

MIPAS-Family-evaluation of a new multi-modal behavioral training program for pediatric headaches: clinical effects and the impact on quality of life.

Several meta-analyses have demonstrated that the combination of electrical muscle activity and Temperature Biofeedback could be regarded as gold standard in chronic pediatric headaches. However, these techniques seem to be uneconomical and furthermore they are not directed to improve the social competence as well as resolve possible impairments in daily activities of the child. Therefore, multi-modal behavioral techniques have been proposed, but no studies comparing these with the gold standard were conducted. The present study compared the impact of a new multi-modal behavioral education and training program--MIPAS-Family--with a combined Biofeedback treatment, evaluating clinical efficacy as well as the effect on the quality of life (QoL) of children with chronic headaches. Thirty-four children and adolescents with recurrent headache, ranging from 7 to 16 years, were randomly assigned to the MIPAS-Family (N = 19) or the Biofeedback (N = 15) condition. All patients were diagnosed by the criteria of the International Headache Society. The children and their parents completed headache diaries, diaries of daily living activities and a QoL questionnaire (KINDL). Both groups showed significant improvements concerning the headache intensity and headache duration. We found no significant differences in the main headache parameters between both treatments. After the treatments, the children were less disturbed by their headaches in the domains school, homework, and leisure time. In conclusion, MIPAS-Family is as effective as Biofeedback but it is more cost-effective and addresses the whole family and the daily activities