The Patient Deficit Model Overturned: a qualitative study of patients' perceptions of invitation to participate in a randomized controlled trial comparing selective bladder preservation against surgery in muscle invasive bladder cancer (SPARE, CRUK/07/011)

Abstract

BackgroundEvidence suggests that poor recruitment into clinical trials rests on a patient ‘deficit’ model – an inability to comprehend trial processes. Poor communication has also been cited as a possible barrier to recruitment. A qualitative patient interview study was included within the feasibility stage of a phase III non-inferiority Randomized Controlled Trial (RCT) (SPARE, CRUK/07/011) in muscle invasive bladder cancer. The aim was to illuminate problems in the context of randomization.MethodsThe qualitative study used a ‘Framework Analysis’ that included ‘constant comparison’ in which semi-structured interviews are transcribed, analyzed, compared and contrasted both between and within transcripts. Three researchers coded and interpreted data.ResultsTwenty-four patients agreed to enter the interview study; 10 decliners of randomization and 14 accepters, of whom 2 subsequently declined their allocated treatment.The main theme applying to the majority of the sample was confusion and ambiguity. There was little indication that confusion directly impacted on decisions to enter the SPARE trial. However, confusion did appear to impact on ethical considerations surrounding ‘informed consent’, as well as cause a sense of alienation between patients and health personnel.Sub-optimal communication in many guises accounted for the confusion, together with the logistical elements of a trial that involved treatment options delivered in a number of geographical locations.ConclusionsThese data highlight the difficulty of providing balanced and clear trial information within the UK health system, despite best intentions. Involvement of multiple professionals can impact on communication processes with patients who are considering participation in RCTs. Our results led us to question the ‘deficit’ model of patient behavior. It is suggested that health professionals might consider facilitating a context in which patients feel fully included in the trial enterprise and potentially consider alternatives to randomization where complex interventions are being tested.Trial RegistrationISRCTN61126465

Identifying components in consent information needed to support informed decision making about trial participation: An interview study with women managing cancer

“…The context of trial information delivery such as how and when options and information are presented, by whom and with what purpose has a significant influence on patients' evaluation of information, decision making strategies and ultimately their decisions (McCann et al, 2013;Moynihan et al, 2012). From the science behind people's decision making, we know that context affects the extent to which patients are enabled to use cues from the context (use heuristic strategies) or be reasoned (use systematic strategies) in their decision making (Chaiken, 1980;Tversky & Kahneman, 1981).…”

“…trial offered by a patient's treating doctor in the consultation may be evaluated differently to when offered by a research nurse before or after the consultation) (McCann et al, 2013) b) framing of the trial offer and information (e.g. depending on who is providing information, it may be framed positively or negatively, which then impacts on patients' evaluation of that information and choices) (Moynihan et al, 2012). Evidence suggests personal views of health professionals about clinical equipoise, need for trial, patient's eligibility etc.…”

“…Patients and professionals have described informed consent for a trial as an empty ritual in which patients are provided with complex information that is difficult to understand and has little impact on their decision making (Armstrong et al, 2012;Lidz et al, 2004). Although the information provided during elicitation of informed consent has improved (Bjorn et al, 1999;Flory & Emanuel, 2004;Synnot et al, 2014), patients' understanding of consent remains suboptimal, leaving unmet patient needs (Bell & Balneaves, 2015;Brehaut et al, 2012a;Gillies et al, 2014;Moynihan et al, 2012). Previous studies show that patients possess poor knowledge and understanding about key aspects of trial processes and treatments (DixonWoods et al, 2007;Lidz et al, 2004;Pope et al, 2003) and find it difficult to integrate the information with their values and goals (Baker et al, 2013).…”

“…Previous studies show that patients possess poor knowledge and understanding about key aspects of trial processes and treatments (DixonWoods et al, 2007;Lidz et al, 2004;Pope et al, 2003) and find it difficult to integrate the information with their values and goals (Baker et al, 2013). Patients often draw on their prior knowledge or use rule-of-thumb decision strategies when making a choice, rather than evaluate the trial details (Moynihan et al, 2012). These strategies tend to be influenced by contextual and emotional factors that encourage patients to make choices based on cues in the context such as the way the trial was communicated or their relationship with trial recruiters (McCann et al, 2013).…”

Consent, including advanced consent, of older adults to research in care homes: a qualitative study of stakeholders’ views in South Wales

“…Advanced consent may be particularly useful if the study intervention is administered in an emergency setting [22]. Other researchers have embedded qualitative sub-studies within trials to investigate participants’ perspectives of the trial recruitment processes [23-25]. To our knowledge there has been no previous research that has explored the views of residents, their relatives, or care home staff, about the potential, and problems, of conducting research within care homes, including issues of advanced consent and loss of capacity.…”