AI Article Synopsis
- A Royal Statistical Society Working Party emphasized the need for more numerical descriptions of risk in first-in-man clinical trials, especially as the industry grows in Asia.
- A study was conducted with cancer and arthritis patients in Singapore where participants evaluated risk information presented in different formats (frequency, percentage, verbal) and sequences to determine their willingness to participate in trials.
- Results showed that the format of risk presentation did not affect their willingness to participate, but most preferred the frequency format; however, the understanding of verbal descriptors varied significantly from European guidelines.
Article Abstract
Background: A Royal Statistical Society Working Party recently recommended that "Greater use should be made of numerical, as opposed to verbal, descriptions of risk" in first-in-man clinical trials. This echoed the view of many clinicians and psychologists about risk communication. As the clinical trial industry expands rapidly across the globe, it is important to understand risk communication in Asian countries.
Methods: We conducted a cognitive experiment about participation in a hypothetical clinical trial of a pain relief medication and a survey in cancer and arthritis patients in Singapore. In part 1 of the experiment, the patients received information about the risk of side effects in one of three formats (frequency, percentage and verbal descriptor) and in one of two sequences (from least to most severe and from most to least severe), and were asked about their willingness to participate. In part 2, the patients received information about the risk in all three formats, in the same sequence, and were again asked about their willingness to participate. A survey of preference for risk presentation methods and usage of verbal descriptors immediately followed.
Results: Willingness to participate and the likelihood of changing one's decision were not affected by the risk presentation methods. Most patients indicated a preference for the frequency format, but patients with primary school or no formal education were indifferent. While the patients used the verbal descriptors "very common", "common" and "very rare" in ways similar to the European Commission's Guidelines, their usage of the descriptors "uncommon" and "rare" was substantially different from the EU's.
Conclusion: In this sample of Asian cancer and arthritis patients, risk presentation format had no impact on willingness to participate in a clinical trial. However, there is a clear preference for the frequency format. The lay use of verbal descriptors was substantially different from the EU's.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2949696 | PMC |
| http://dx.doi.org/10.1186/1472-6947-10-55 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Teaching high quality paediatric basic life support to laypeople: The development and evaluation of a virtual simulation game.
Resusc Plus
January 2025
Department of Paediatrics, Division of Paediatric Critical Care, CHEO, 401 Smyth Rd, Ottawa, Ontario K1H 8L1, Canada.
Background: Self-directed training has been recognized as a reasonable alternative to traditional instructor-led formats to teach laypeople Basic Life Support (BLS). Virtual tools can facilitate high-quality self-directed resuscitation education; however, their role in teaching paediatric BLS remains unclear due to limited empiric evaluation and suboptimal design of existing tools.
Aim: We describe the development and evaluation of a virtual simulation game (VSG) designed to teach high-quality paediatric BLS using a self-directed, online format with integrated deliberate practice and feedback.
Acceptability of interactive post-endodontic restoration decision making application among undergraduate dental students.
J Dent Sci
December 2024
School of Dentistry, University of Queensland, Brisbane, Australia.
Background/purpose: Selecting an appropriate coronal restoration after root canal treatment requires careful consideration, however, there is a lack of established web-based tool that is based on clear guidelines for suitable post-endodontic restorations. Hence, we aimed to design and determine the acceptability of an interactive application to aid the decision making process for post-endodontic restoration among the undergraduate dental students.
Materials And Methods: A web-based post-endodontic restoration decision making interactive application, ( was developed after a detailed review of available literature.
Objectives: Intensive care unit (ICU) clinicians stop antibiotics more often, with a negative infection: point-of-care test (PCR-POCT). Simulated cases of diagnostic uncertainty regarding infection resolution led clinicians to choose options such as procalcitonin (PCT) and/or PCR-POCTs +/- de-escalation to aid stop decisions. We hypothesised that a direct infection indicator, PCR-POCT, would influence stop judgements more than indirect PCT.
View Article and Find Full Text PDFExperience, access and utilisation of fertility care for infertile men within the biomedical sector in urban Bangladesh: protocol for a qualitative study.
BMJ Open
December 2024
Department of Sexual and Reproductive Health and Research, Human Reproduction Program, World Health Organization, Geneva, Switzerland.
Introduction: One in six people of reproductive age experience infertility in their lifetime throughout the world, often with devastating consequences. Men are often invisible in infertility research and services, yet masculinity and reproductive agency intersect within social, cultural and religious contexts to shape their experiences of infertility and masculine expression. This study aims to provide insights into the lived experience of male infertility, the availability and access of infertility services for men within the biomedical sector in Bangladesh and the potential willingness of men to use home-based semen testing.
View Article and Find Full Text PDFScaling up of parenting support to prevent violence against children in Tanzania: insights from policymakers and service providers.
Implement Sci Commun
January 2025
Department of Interdisciplinary Social Science, Utrecht University, Utrecht, Netherlands.
Background: Evidence shows that parenting behaviours, including the use of violent discipline, can be changed through programmatic interventions. This study seeks to examine how policymakers and service providers in Tanzania perceive the provision of parenting support as a strategy to prevent violence against children and what the enabling and hindering factors are for the scale-up of existing evidence-based parenting supports. It does this by applying Daly's analytical framework for parenting support.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!