This form was an adaptation of the form developed by Wittwer et al (2000) and used in other stroke rehabilitation trials (Bernhardt et al 2007). It was not possible to blind the treating therapists to which therapy sessions were video-taped, but in an attempt to find more minimise bias, the exact purpose of the study was concealed from the therapists and CIRCIT trial participants. They were told only that the data from the videos would be used to evaluate adherence to the CIRCIT trial protocol. The researcher (GK) was blinded to the CIRCIT trial therapy data forms when analysing the video recordings. The researcher viewed
the videos and used the onscreen time display to determine the total duration of the therapy sessions and the time spent engaged in each physical activity category (rounded to the nearest minute). Standard operational definitions were used to determine the beginning and end of a therapy session. Definitions of various physical activity sub-categories were on the CIRCIT trial therapy data form (Appendix 1). This method of video analysis has been shown to have acceptable
intra-rater reliability (Elson et al 2009). Total active time was determined as the sum of time spent in each category of physical activity. Total inactive time was determined as total therapy Ku 0059436 time minus total active time. The level of agreement between video-recorded and therapist estimated times for total therapy duration, total active time,
and ADAMTS5 total inactive time were examined using intraclass correlation coefficients (ICC), and by examining Bland and Altman plots for evidence of systematic bias. It is important to determine not only whether systematic bias is present, but also whether the magnitude of any bias is clinically relevant. In the absence of published data, we consulted a group of senior physiotherapists experienced in stroke rehabilitation and decided that the percentage mean difference (or percentage error between the therapist estimations and video recordings of the therapy time) would need to be greater than 15 per cent (equivalent to 9 minutes of a 60-minute therapy session) to be clinically relevant. This judgment was based on how accurate we could expect clinicians to be in judging therapy time, rather than the impact this inaccuracy may have on clinical outcomes. A priori sample size calculations were based on being able to detect a minimum correlation of 0.8 between videorecorded and therapist-estimated total therapy duration. A sample size of 40 pairs of therapy sessions provides over 99% power at α = 0.05 to detect a correlation of 0.8 ( Portney and Watkins, 2009) with a 95% CI of 0.65 to 0.89 (based on Fisher’s z transformation).