Key findings
antipsychotic reduction, psychosis
SAID, RECRUITMENT
Ultimately, over a quarter of people (27.1%) who participated in the acceptability study enrolled in the randomized trial of antipsychotic reduction. This was fewer than the 71.9% of participants who said they would consider taking part when they were interviewed, but nevertheless it represented a substantial number of people who were recruited to the trial quickly and easily once it was opened. This is particularly valuable in a trial involving starkly different treatment strategies, since such trials may be particularly difficult to recruit to [People’s reasons for wanting to take part in the study reflect other research in finding that altruism was a common motivation [Of those who indicated an interest in taking part in the trial, 56% did not end up participating, either because they declined or were not considered eligible. Although we do not know the precise reasons why people were not eligible, this is a high number, given that the eligibility criteria for the trial were almost identical to those for the acceptability study. Some people may have become mentally unwell between taking part in the acceptability study and being approached about the trial, and therefore not satisfied the requirement to be mentally stable. Another potential reason is different judgements about risk. For both studies, an exclusion criteria was if the clinician judged that the participant posed ‘a serious risk of harm to self or others’. This criteria is likely to have been applied more leniently in the acceptability study, which only involved an interview, than in the randomised trial that involved the possibility of having antipsychotic medication reduced and discontinued.The number of people who declined to enter the trial after having expressed an interest in doing so may reflect changes in circumstances, or that people’s decision-making changes when confronted with the reality, rather than only the theoretical possibility, of entering a trial of this sort. Other data from this acceptability study suggests that fear of relapse was a prevalent reason why people did not want to reduce or discontinue their antipsychotic medication [The finding that women were more likely to be recruited to the trial than men contrasts with other antipsychotic trials in which women are generally under-represented [Implications for research.Running an acceptability study can provide valuable information to help understand recruitment to a randomised trial, including potential barriers to participation and characteristics that may make it more difficult to recruit particular groups. This enables the construction of a detailed trial recruitment strategy. This might include adapting the language used to explain the need for the trial, including the concept of clinical equipoise, the process of randomisation and the intervention itself to make it more accessible and avoid misunderstandings. Methods to target people from ethnic minority backgrounds can also be devised, including the use of interpreters when resources allow. However, the fact that there were no clinical predictors of who would ultimately enroll means there is no obvious way of targeting recruitment and recruitment efforts need to be broad and inclusive.An acceptability study also allows researchers to access a sample of people who are likely to be eligible and interested in participating as soon as the recruitment stage of the trial opens, enabling more rapid recruitment. Participation in an acceptability study can improve patient familiarity with research processes in general, and by providing advanced information about the trial, can make it a less intimidating decision to agree to take part. If the individual researchers conducting the acceptability study and trial recruitment can be kept the same, as they were in many instances in the current study, then this establishes rapport and provides further reassurance, thereby improving the chances of recruitment to the trial. Experience from other trials involving people with psychosis has shown that building relationships between researchers participants, as well as clinicians, helps with recruitment [Despite its potential usefulness, the relatively large proportion of people who expressed interest in participating in the trial but then did not take part (56%) indicates that this sort of acceptability study can over-estimate rates of trial participation, which needs to be factored into recruitment estimations and planning.Limitations.The data in the current study was gathered in reference to a particular trial. Levels of recruitment from an acceptability study are likely to vary according to the nature of the trial and the interventions involved. The RADAR trial involved strongly contrasting intervention and control conditions and reasons that people gave for not wanting to take part included a preference for the intervention (antipsychotic reduction) and a preference for the control (maintenance antipsychotic treatment) arm. Trials that offer less starkly contrasting treatments, or those in which the intervention represents an addition to usual care, may not have the same challenges.The RADAR trial also required clinicians to make a decision about one of the eligibility criteria (presenting a risk of harm to oneself or others). Although the eligibility criteria of the acceptability study were intended to match those of the randomized trial, it is likely that this criterion was applied differently, resulting in a lower proportion of people being considered eligible for the trial than anticipated. Unfortunately, we did not have details about the precise reasons why people were not considered eligible for the trial, so it is difficult to confirm this suspicion.