Study goal: This study was carried out to answer the following research question: which motivation do healthy volunteers have to participate in phase I clinical trials? - Methods: A literature search was done through Google Scholar and Academic Search Premier, followed by three interviews with volunteers who had recently concluded their participation in a (non-commercial) phase I trial. - Results: Our literature search revealed mainly commercial motives for volunteers to participate in phase I clinical trials. The interviews (with volunteers in a non-commercial trial) showed that other factors may also play a decisive role, such as: (1) wish to support the investigator (2) wish to contribute to science, (3) access to more/better health care (4) sociability: possibility to relax and to communicate with other participants (5) general curiosity. Precondition is that risks and burden are deemed acceptable. - Conclusions: financial remuneration appears to be the predominant motive to participate voluntarily in a clinical trial. Other reasons were also mentioned however, such as general curiosity, the drive to contribute to science and the willingness to help the investigator. In addition, social reasons were given such as possibility to relax and to meet other people. Potential subjects state that they adequately assess the (safety) risks of participating in a trial as part of their decision process.
Background: Increasing attention to palliative care for the general population has led to the development of various evidence-based or consensus-based tools and interventions. However, specific tools and interventions are needed for people with severe mental illness (SMI) who have a life-threatening illness. The aim of this systematic review is to summarize the scientific evidence on tools and interventions in palliative care for this group. Methods: Systematic searches were done in the PubMed, Cochrane Library, CINAHL, PsycINFO and Embase databases, supplemented by reference tracking, searches on the internet with free text terms, and consultations with experts to identify relevant literature. Empirical studies with qualitative, quantitative or mixed-methods designs concerning tools and interventions for use in palliative care for people with SMI were included. Methodological quality was assessed using a critical appraisal instrument for heterogeneous study designs. Stepwise study selection and the assessment of methodological quality were done independently by two review authors. Results: Four studies were included, reporting on a total of two tools and one multi-component intervention. One study concerned a tool to identify the palliative phase in patients with SMI. This tool appeared to be usable only in people with SMI with a cancer diagnosis. Furthermore, two related studies focused on a tool to involve people with SMI in discussions about medical decisions at the end of life. This tool was assessed as feasible and usable in the target group. One other study concerned the Dutch national Care Standard for palliative care, including a multicomponent intervention. The Palliative Care Standard also appeared to be feasible and usable in a mental healthcare setting, but required further tailoring to suit this specific setting. None of the included studies investigated the effects of the tools and interventions on quality of life or quality of care. Conclusions: Studies of palliative care tools and interventions for people with SMI are scarce. The existent tools and intervention need further development and should be tailored to the care needs and settings of these people. Further research is needed on the feasibility, usability and effects of tools and interventions for palliative care for people with SMI.
From the article: Abstract Sub-chronic toxicity studies of 163 non-genotoxic chemicals were evaluated in order to predict the tumour outcome of 24-month rat carcinogenicity studies obtained from the EFSA and ToxRef databases. Hundred eleven of the 148 chemicals that did not induce putative preneoplastic lesions in the sub-chronic study also did not induce tumours in the carcinogenicity study (True Negatives). Cellular hypertrophy appeared to be an unreliable predictor of carcinogenicity. The negative predictivity, the measure of the compounds evaluated that did not show any putative preneoplastic lesion in de sub-chronic studies and were negative in the carcinogenicity studies, was 75%, whereas the sensitivity, a measure of the sub-chronic study to predict a positive carcinogenicity outcome was only 5%. The specificity, the accuracy of the sub-chronic study to correctly identify non-carcinogens was 90%. When the chemicals which induced tumours generally considered not relevant for humans (33 out of 37 False Negatives) are classified as True Negatives, the negative predictivity amounts to 97%. Overall, the results of this retrospective study support the concept that chemicals showing no histopathological risk factors for neoplasia in a sub-chronic study in rats may be considered non-carcinogenic and do not require further testing in a carcinogenicity study.
