Restoration of Hypoglycemia Awareness After Islet Transplantation

OBJECTIVE—To determine the impact of islet transplantation (ITx) on hypoglycemia awareness in patients with unstable type 1 diabetes and its relation to islet function

Islet transplantation from a nationally funded UK centre reaches socially deprived groups and improves metabolic outcomes

Acknowledgements We thank the transplant nurses involved with the Scottish Islet Transplant Programme (T. McGilvray, J. Davidson, M. Phillips and C. Jansen) for help with participant assessment. We thank the Scottish National Blood Transfusion Services including the Histocompatibility and Immunogenetics Team for HLA typing and antibody screening, and the Tissue and Cells Team (A. Timpson, L. Fraser, L. Irvine and P. Henry) for islet isolation and product release testing. We acknowledge the Departments of Transplantation, Diabetes and Interventional Radiology at NHS Lothian for all aspects of patient care and the organ procurement programme. We thank J. Shaw and A. Brooks from the Department of Regenerative Medicine for Diabetes at the University of Newcastle for advice regarding CGMS. C-peptide assays were performed by the NIHR Cambridge Biomedical Research Centre, Core Biochemical Assay Laboratory. Funding: The Scottish Islet Transplant Programme is funded by the National Services Division. This research was funded by Diabetes UK (Biomedical and Psychosocial Outcomes of Islet Transplantation; Grant no. BDA 06/0003362), Diabetes Research and Wellness Foundation, Diabetes Foundation, Juvenile Diabetes Research Foundation and the Royal Infirmary Diabetes Treatment Trust Fund. Open Access: This article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.Peer reviewedPublisher PD

What information and the extent of information research participants need in informed consent forms: a multi-country survey

Background: The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research. Methods: This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important). Results: Of the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be \u27moderately important\u27 to \u27very important\u27 for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively). Conclusions: Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF