Treatment contamination Sample Clauses
Treatment contamination.
1.1 to evaluate the fidelity of MI (▇▇▇▇▇▇ et al., 2005, 2010), and the Behavioural Change Counselling Index (▇▇▇▇▇) to assess the delivery of CBT skills (▇▇▇▇ et al., 2005). Further information about these scales will be given in Chapter 3. Treatment sessions of 33 patients in the D6 intervention group and 36 in the standard care group (3.4% of all sessions) were rated (▇▇▇▇▇▇ et al., 2018). The results of the fidelity assessment are shown in Table 1.1. There was evidence for a higher proportion of open questions in the D6 intervention group and a larger reflection/question ratio in the standard care group. There was no evidence of a difference between the trial arms for the other MITI domains and ▇▇▇▇▇ Practitioner Score. The fidelity assessment showed that there may have been some contamination of the control group. For example, the MITI Global Spirit and Global Empathy scores showed that nurses may have been using psychological treatment techniques to a limited extent. Global Spirit (mean; SD) 2.87 (0.87) 3.23 (1.13) .14 Global Empathy (median; 2.50 (2.00-3.00) 3.00 (2.00-4.00) .19 IQR) Percent Complex 40.4 (17.4) 35.2 (19.8) .25 Reflections (mean; SD) Percent Open Questions (mean; SD) 24.9 (10.0) 36.4 (17.3) <.01 Reflection/question ratio 0.74 (0.53-1.19) 0.57 (0.42-0.72) .03 Percent MI-Adherent 53.6 (27.6) 58.4 (31.8) .51 (mean; SD) ▇▇▇▇▇ Practitioner Score 1.12 (0.55) 1.33 (0.56) .12 (mean; SD) Table 1.1: Mean scores of treatment fidelity scales (MITI and ▇▇▇▇▇) by treatment group from D6’s primary assessment. (median, IQR) † Based on result of either a t-test or ▇▇▇▇-▇▇▇▇▇▇▇ U test. The anecdotal evidence of the standard care nurse who was particularly aware of psy- chological treatment techniques, the results of the primary analysis treatment fidelity assessment, and the small estimate of treatment effectiveness suggested that there may have been some treatment contamination. For this reason, it was decided to measure treatment fidelity for as many participants as possible and then to account for any con- tamination or non-compliance in an efficacy analysis of the trial. I will present the treatment fidelity assessment in Chapter 3 and the efficacy analysis in Chapter 7.
