PPI 2015 Unit III

Consumer involvement in the design of a randomized controlled trial of routine oxygen supplement after acute stroke (Ali et al)

In this study, people affected by stroke were consulted about the design of a clinical trial that aimed to test the effects of oxygen supplementation following an acute stroke. The patients were asked to comment on consent issues, the relevance and acceptability of the outcome measures and the preferred method of follow-up. Following the consultation, one of the main changes that was made to the trial was to introduce new outcome measures. The most commonly used stroke assessment scales focus on physical health and physical recovery. However, the patients pointed out that quality of life after stroke is determined more by cognitive and emotional problems than by the level of disability. They therefore wanted the trial to assess the impact of treatment on communication, mood, cognitive function, tiredness and sleep. As these are not well represented in the standard assessment tools, the researchers added their own questions to the assessment questionnaires. This helped to make the results of the study more relevant to people affected by stroke.