Evidence Library

Method: Three focus groups were held with people affected by stroke and then participants were asked to complete questionnaires. People were asked for their views on the importance of the study, consent issues, relevance of the outcome measures and preferences for follow-up.

 

Findings/Recommendations:  Although consumer involvement helped to make the study more relevant it also led to difficult scientific and ethical conflicts in developing the trial protocol. Consumers wanted to consider different outcome measures to those suggested by the researchers. The standard measures are based on physical health and physical recovery. However, consumers wanted to measure outcomes related to communication, mood, tiredness, cognitive function and sleep. This is because their quality of life is determined more by their cognitive and emotional problems than by their disability. But this posed a problem for the researchers because the consumer outcomes are not well represented in the standard assessment tools and are more difficult to measure. The researchers therefore developed new tools to measure these outcomes, but were concerned that these were less scientifically rigorous.

 

Consumers also said they did not want their relatives to be asked to give consent on their behalf because they did not want their next of kin to experience any additional stress. They wanted to waiver the need for consent. However, asking relatives to give consent is considered to be the standard ethical practice.