Risk communication in clinical trials: a cognitive experiment and a survey.

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.

Adaptive Brain-Computer Interface Systems For Communication in People with Severe Neuromuscular Disabilities

Brain-computer interfaces (BCI) have the potential to restore communication or control abilities in individuals with severe neuromuscular limitations, such as those with amyotrophic lateral sclerosis (ALS). The role of a BCI is to extract and decode relevant information that conveys a user's intent directly from brain electro-physiological signals and translate this information into executable commands to control external devices. However, the BCI decision-making process is error-prone due to noisy electro-physiological data, representing the classic problem of efficiently transmitting and receiving information via a noisy communication channel.

This research focuses on P300-based BCIs which rely predominantly on event-related potentials (ERP) that are elicited as a function of a user's uncertainty regarding stimulus events, in either an acoustic or a visual oddball recognition task. The P300-based BCI system enables users to communicate messages from a set of choices by selecting a target character or icon that conveys a desired intent or action. P300-based BCIs have been widely researched as a communication alternative, especially in individuals with ALS who represent a target BCI user population. For the P300-based BCI, repeated data measurements are required to enhance the low signal-to-noise ratio of the elicited ERPs embedded in electroencephalography (EEG) data, in order to improve the accuracy of the target character estimation process. As a result, BCIs have relatively slower speeds when compared to other commercial assistive communication devices, and this limits BCI adoption by their target user population. The goal of this research is to develop algorithms that take into account the physical limitations of the target BCI population to improve the efficiency of ERP-based spellers for real-world communication.

In this work, it is hypothesised that building adaptive capabilities into the BCI framework can potentially give the BCI system the flexibility to improve performance by adjusting system parameters in response to changing user inputs. The research in this work addresses three potential areas for improvement within the P300 speller framework: information optimisation, target character estimation and error correction. The visual interface and its operation control the method by which the ERPs are elicited through the presentation of stimulus events. The parameters of the stimulus presentation paradigm can be modified to modulate and enhance the elicited ERPs. A new stimulus presentation paradigm is developed in order to maximise the information content that is presented to the user by tuning stimulus paradigm parameters to positively affect performance. Internally, the BCI system determines the amount of data to collect and the method by which these data are processed to estimate the user's target character. Algorithms that exploit language information are developed to enhance the target character estimation process and to correct erroneous BCI selections. In addition, a new model-based method to predict BCI performance is developed, an approach which is independent of stimulus presentation paradigm and accounts for dynamic data collection. The studies presented in this work provide evidence that the proposed methods for incorporating adaptive strategies in the three areas have the potential to significantly improve BCI communication rates, and the proposed method for predicting BCI performance provides a reliable means to pre-assess BCI performance without extensive online testing.

Factors Impacting Grandparent and Grand Child Communication Across Sex- Related Topics in Kenya

Background: Although many studies have investigated sexual communication between parents and children in Kenya, none have focused singularly on grandparent and grandchild communication when grandparents are primary caregivers. Further, few studies have asked about specific topics related to sex, instead asking generally about “sex related topics” or focusing on HIV/AIDS. This research aims to investigate communication on ten specific sex- related topics between grandparents who are primary caregivers and their grandchildren. The primary research aim was to identify facilitators and barriers to grandparent-grandchild communication associated with frequency of communication. A secondary exploratory question was whether frequency of communication and youth satisfaction with communication were associated with youth’s desire for more communication in the future. Methods: The study was conducted in urban and peri-urban central Kenya. A convenience sample of 193 grandparents and 166 twelve to fifteen year old grandchildren were identified by community health workers. A cross sectional survey assessed nine potential barriers or facilitators to communication (e.g., frequency of communication, perceived grandparent knowledge, grandparent sense of responsibility to communication on a given topic) on ten specified sex- related topics (e.g., peer pressure on sex topics, romantic relationships, condoms). Bivariate and multivariable analyses identified significant associations between communication variables and the outcomes of interest. Results: Bivariate regression showed that higher grandchild age, grandchild gender, higher perceived grandparent knowledge, higher perceived grandparent comfort, higher grandparent-reported sense of responsibility, higher grandparent-reported belief that child should be aware of a given topic before initiating in sex, and higher youth’s own comfort during communication, were significantly associated with higher levels of communication frequency. In the multivariable model, higher grandchild age, gender, higher comfort during communication, and higher perceived grandparent knowledge remained significantly associated with higher levels communication frequency. For the secondary research question, higher communication frequency and higher levels of youth satisfaction were both significantly associated with higher levels of youth desire for more communication in bivariate regression, and higher levels of youth’s satisfaction with communication remained significantly associated with higher levels of youth’s desire for more in the adjusted analysis. Conclusions: This study found that several potential barriers and facilitators of communication are associated with both frequency of and youth’s desire for more communication. The association between grandchild age, gender and perceived grandparent knowledge and frequency of communication is similar to findings from other studies that have examined sex-related communication between parent primary caregivers and children. This finding has important implications for understanding grandparent and grandchild communication, and communication on specific topics in a population from Kenya. The positive association between youth satisfaction of and desire for more communication has important education policy and intervention implications, suggesting that if youth are satisfied with the communication with their caregivers, they may want to learn more.