Among the authors with the most experience in trials using adaptive designs (DB, RL), informed consent has not felt to be substantively more challenging with ACT studies, compared with non-adaptive trials.
Although not all patients will want to take part, our previous experience in trials of perioperative adjuncts to surgery has shown high levels of patient recruitment (80 100%) with only 7% declining the pilot study.
Many lessons have been learnt from these experiences in trial design, and selection of agents and doses for future trials.
By using a state-space model (see the Experimental Procedures), I estimated how much the initial direction of each hand in trial n + 1 (at 160 ms) was influenced by a perturbation experienced in trial n, either on the same hand (within-hand adaptation rate) or on the other hand (between-hand adaptation rate).
Between January and December 2012, 23 volunteers who had been in the two trials for over 6 months, consented to be interviewed about their experience in the trial three times over a period of nine months.
Patients who were told that they would receive a painkiller, whether they actually received it or not, had the same experience in the trial as those who secretly received between six and eight milligrams of morphine — a significant amount.
These numbers were based on MC delivery experience in the trial in Orange Farm and were consistent with a recent study of 4 clinics in Swaziland [10].
Surveys asked subjects about their experience in the trial, whether they felt any improvement in their AUDs, and whether they perceived their assigned study interventions to be effective.
According to the experience in previous trial, participating in a study like this is unlikely to be burdensome for patients [ 18, 4, 35, 36].
