Qualitative research methods are increasingly included in health services research, conventionally to help in the interpretation of quantitative results or understanding of trials.12,14,15
In the ProtecT feasibility study we inverted the normal relations between these methods and embedded the randomised trial within the qualitative study. We showed that the integration of qualitative research methods allowed us to understand the recruitment process and elucidate the changes necessary to the content and delivery of information to maximise recruitment and ensure effective and efficient conduct of the trial. The routine recording of information appointments was crucial: the content and method of delivery of the information provided the context within which the men's interpretations of the information could be set.
The qualitative research illuminated four ways in which study information was having a negative impact on the study. Some of the issues raised were simple, such as reordering the presentation of treatments and avoiding terms that had particular and unanticipated meanings for patients. These “simple” issues would probably not have become apparent without the qualitative research. “Watchful waiting,” for example, is commonly used to describe a non-interventionist treatment. In lay terms, this conveys an impression of wilful neglect, in which the disease is watched and everyone waits for an event—death. It was only when the non-radical arm was redefined as “active monitoring” that patients and clinicians gained confidence in it as a legitimate option. Whether the term is more acceptable in other countries, such as the United States, needs investigation.
Other issues that emerged were more complex. It has been shown elsewhere that patients have difficulty with randomisation.15–17
In this study most men could recall and understand randomisation, but they often found it difficult to accept. Equipoise was particularly difficult but has received remarkably little examination in the literature. We found it essential that recruiting staff were able to express confidently that men were eligible for all three treatments, that the most effective treatment was unknown, that a trial was urgently needed, and that randomisation could provide a plausible way of reaching a decision. If recruiters gave any indication that they were not completely committed to these aspects, patients would question randomisation, often using subtle and sophisticated reasoning that surprised some recruiters.
Although our intention was to maximise both recruitment and informed consent, changes to the content and delivery of information could potentially be used to coerce patients and artificially inflate randomisation rates. One outcome might then be to increase dropouts, but, as the table shows, the proportion who accepted the treatment allocation remained similar throughout the study. We are currently exploring reasons for rejection of allocation. The process of verbally presenting study information and obtaining written consent is not usually tape recorded or available for later scrutiny as they were here. Recruitment and informed consent in other trials may not have been maximised, because of different interpretations by patients and researchers. Although these methods carry a danger of coercion, our findings indicate that we ensured that the study became more ethical over time as participants received unambiguous information that allowed them to make an accurately informed decision about whether to accept randomisation. Many men rejecting randomisation early on had received unbalanced information open to misinterpretation.
The controversial nature of the study and the extreme differences between the treatment arms might limit the generalisability of the findings to other randomised trials. However, controversial trials attempting to tackle difficult or “impossible” questions could be the very studies that need to benefit from the qualitative evaluation used here. Indeed, the extreme nature of the treatment choices illuminated issues that were very difficult and encouraged patients to be explicit about their interpretations. The plausibility of these findings suggests that these methods could have a role in improving the efficiency and conduct of trials in general.
The findings also support the contention that the conduct of trials is not straightforward. The concepts inherent in trials, particularly randomisation and equipoise, are complex and difficult and place particular demands on participants and recruiters. Better training and information for these groups may help, but this study suggests that qualitative methods need to be used in feasibility phases in order to understand recruitment to particular trials.
Health services research is a developing tradition, in which different disciplines and paradigms are brought together to tackle health related questions. Combining different approaches can be difficult, but the ProtecT study brought together the qualitative traditions of sociology and anthropology, epidemiological and statistical disciplines informing randomised trial design, and academic urology and nursing. The method of the study contravened conventional approaches by being driven not by the randomised trial design but by the qualitative research. Effectively, the ProtecT feasibility study embedded the randomised trial within the qualitative research and followed a sociological iterative approach. Thus qualitative research methods applied in combination with open minded clinicians and flexible or innovative trial designs may enable even the most difficult evaluative questions to be tackled and have substantial impacts even on apparently routine and uncontroversial trials.
Key learning points
Recruitment to randomised controlled trials is often problematic, potentially threatening the power and external validity of trials and wasting resources
Embedding the controversial ProtecT randomised trial within qualitative research allowed detailed investigation of the presentation of study information by recruiters and its interpretation by participants
Changes to the content and delivery of study information increased recruitment rates from 40% to 70%
The embedding of randomised controlled trials in qualitative research may enable even the most difficult evaluative questions to be tackled and could have substantial impacts on recruitment to apparently routine trials