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Disease severity probably also affects the ease of completing the outcomes instruments and this may be related to the subject's physical condition.
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From the 147 students completing the outcome measures, 82 (56%) students also completed the EBPQ outcome measure.
Eleven men who met the eligibility criteria were recruited from two hospitals in Perth, Western Australia, with all receiving the intervention and completing the outcome measures throughout the 12 months of follow-up.
In addition their views on taking part in the study (e.g. being randomized) are sought in qualitative interviews, and their views on completing the outcome measures are recorded when they are completing them.
The low completion rate of outcome assessments for this RCT increases the risk of bias in the study regarding the generalisability of results due to the greater likelihood of students with a higher affiliation to EBM completing the outcome assessments.
However, in depth qualitative data on their views of the therapy, taking part in the study and completing the outcome measures will be obtained from those who are interviewed.
The proportions completing the outcome assessment were were 89% at month 2, 87% at month 6 and 85% at month 12. Overall, 2181 (78%) of all screen-positive participants were seen at all three follow-up visits.
Of the 147 students completing the outcome assessment, 63 students were placed at an Australia metropolitan hospital, 45 at an Australian rural hospital and 39 at a Malaysian-based hospital.
Neither patient elected to complete the outcomes questionnaires.
One participant withdrew, 10 were removed by the investigator because they did not complete the outcomes questionnaire, and 30 were lost-to-follow-up.
Participants will be requested to complete the outcomes even if they stop using the Wii.
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