Dataset Information

The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials.

ABSTRACT:

Objective

The aim of the study was to investigate how doctors considered and experienced the concept of equipoise while recruiting patients to randomized controlled trials (RCTs).

Study design and setting

In-depth interviews with 32 doctors in six publicly funded pragmatic RCTs explored their perceptions of equipoise as they undertook RCT recruitment. The RCTs varied in size, duration, type of complex intervention, and clinical specialties. Interview data were analyzed using qualitative content and thematic analytical methods derived from grounded theory and synthesized across six RCTs.

Results

All six RCTs suffered from poor recruitment. Doctors wanted to gather robust evidence but experienced considerable discomfort and emotion in relation to their clinical instincts and concerns about patient eligibility and safety. Although they relied on a sense of community equipoise to justify participation, most acknowledged having "hunches" about particular treatments and patients, some of which undermined recruitment. Surgeons experienced these issues most intensely. Training and support promoted greater confidence in equipoise and improved engagement and recruitment.

Conclusion

Recruitment to RCTs is a fragile process and difficult for doctors intellectually and emotionally. Training and support can enable most doctors to become comfortable with key RCT concepts including equipoise, uncertainty, patient eligibility, and randomization, promoting a more resilient recruitment process in partnership with patients.

SUBMITTER: Donovan JL

PROVIDER: S-EPMC4067744 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature

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Publications

The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials.

Donovan Jenny L JL de Salis Isabel I Toerien Merran M Paramasivan Sangeetha S Hamdy Freddie C FC Blazeby Jane M JM

Journal of clinical epidemiology 20140505 8

<h4>Objective</h4>The aim of the study was to investigate how doctors considered and experienced the concept of equipoise while recruiting patients to randomized controlled trials (RCTs).<h4>Study design and setting</h4>In-depth interviews with 32 doctors in six publicly funded pragmatic RCTs explored their perceptions of equipoise as they undertook RCT recruitment. The RCTs varied in size, duration, type of complex intervention, and clinical specialties. Interview data were analyzed using quali ...[more]

PMID: 24811157

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Project description:BackgroundRandomised controlled trials (RCTs) are essential for evidence-based medicine and increasingly rely on front-line clinicians to recruit eligible patients. Clinicians' difficulties with negotiating equipoise is assumed to undermine recruitment, although these issues have not yet been empirically investigated in the context of observable events. We aimed to investigate how clinicians conveyed equipoise during RCT recruitment appointments across six RCTs, with a view to (i) identifying practices that supported or hindered equipoise communication and (ii) exploring how clinicians' reported intentions compared with their actual practices.Methods and findingsSix pragmatic UK-based RCTs were purposefully selected to include several clinical specialties (e.g., oncology, surgery) and types of treatment comparison. The RCTs were all based in secondary-care hospitals (n = 16) around the UK. Clinicians recruiting to the RCTs were interviewed (n = 23) to understand their individual sense of equipoise about the RCT treatments and their intentions for communicating equipoise to patients. Appointments in which these clinicians presented the RCT to trial-eligible patients were audio-recorded (n = 105). The appointments were analysed using thematic and content analysis approaches to identify practices that supported or challenged equipoise communication. A sample of appointments was independently coded by three researchers to optimise reliability in reported findings. Clinicians and patients provided full written consent to be interviewed and have appointments audio-recorded. Interviews revealed that clinicians' sense of equipoise varied: although all were uncertain about which trial treatment was optimal, they expressed different levels of uncertainty, ranging from complete ambivalence to clear beliefs that one treatment was superior. Irrespective of their personal views, all clinicians intended to set their personal biases aside to convey trial treatments neutrally to patients (in accordance with existing evidence). However, equipoise was omitted or compromised in 48/105 (46%) of the recorded appointments. Three commonly recurring practices compromised equipoise communication across the RCTs, irrespective of clinical context. First, equipoise was overridden by clinicians offering treatment recommendations when patients appeared unsure how to proceed or when they asked for the clinician's expert advice. Second, clinicians contradicted equipoise by presenting imbalanced descriptions of trial treatments that conflicted with scientific information stated in the RCT protocols. Third, equipoise was undermined by clinicians disclosing their personal opinions or predictions about trial outcomes, based on their intuition and experience. These broad practices were particularly demonstrated by clinicians who had indicated in interviews that they held less balanced views about trial treatments. A limitation of the study was that clinicians volunteering to take part in the research might have had a particular interest in improving their communication skills. However, the frequency of occurrence of equipoise issues across the RCTs suggests that the findings are likely to be reflective of clinical recruiters' practices more widely.ConclusionsCommunicating equipoise is a challenging process that is easily disrupted. Clinicians' personal views about trial treatments encroached on their ability to convey equipoise to patients. Clinicians should be encouraged to reflect on personal biases and be mindful of the common ways in which these can arise in their discussions with patients. Common pitfalls that recurred irrespective of RCT context indicate opportunities for specific training in communication skills that would be broadly applicable to a wide clinical audience.

Project description:ObjectiveTo assess factors associated with trial participation in the context of a low-risk intervention intended to reduce adverse drug events in recently hospitalized older adults.DesignMixed methods: analysis of data collected during enrollment efforts and focus groups.SettingA large, multispecialty group practice.ParticipantsIndividuals 50 years and older, recently discharged from the hospital and prescribed at least one high-risk medication, were eligible for the trial. Enrollees, decliners, and their caregivers were eligible to participate in focus groups.MeasurementsReasons for declining to participate during the initial invitation as well as reasons for not providing consent were recorded. Focus groups were conducted with eligible individuals to explore reasons for enrolling or declining. We conducted multivariable logistic regression to compare characteristics (including sex, age, healthcare proxy, number and type of medications, visiting nurse services, reason for admission, and length of hospital stay) of those who enrolled with those who did not enroll.ResultsOf 3,606 individuals determined eligible, 3,147 (87%) declined, 98 (3%) verbally consented to participate but did not complete written consent, and 361 (10%) provided written consent and were considered enrolled. Individuals 80 year and older (odds ratio (OR) = 0.44; 95% confidence interval (CI) = 0.30-0.65) and those with visiting nurse services (OR = 0.64; 95% CI = 0.48-0.85) were least likely to enroll. Among those who provided a reason for declining (2,473), the most common was the belief they did not need additional medication assistance (18%). Another 332 (11%) declined because they were receiving visiting nurse services.ConclusionRecruiting older adults recently discharged from the hospital to participate in trials of low-risk, system-level interventions is challenging and may underenroll the oldest individuals and those potentially at the highest risk for adverse events, limiting generalizability of study findings. Alternative study designs may be more effective than individually randomized trials in assessing low-risk, system-level interventions.

Project description:BackgroundAlthough the majority of American Indians/Alaska Natives reside in urban areas, there are very few randomized controlled trials analyzing culturally centered substance use prevention interventions for this population.MethodsWe describe methods employed to recruit and retain urban American Indian/Alaska Native adolescents into a randomized controlled trial, which was focused on testing the potential benefits of a substance use prevention intervention for this population. We also report challenges encountered in recruitment and retention of participants and strategies employed addressing these challenges. Data collection occurred from August 2014 to October 2017.ResultsWe partnered with two community-based organizations in different cities in California. We utilized American Indian/Alaska Native recruiters from communities, placed flyers in community-based organizations, and asked organizations to post flyers on their web and social media sites. We also offered gift cards for participants. Our initial recruitment and retention model was moderately successful; however, we encountered five main challenges: (1) transportation, (2) increasing trust and interest, (3) adding research sites, (4) getting the word out about the project, and (5) getting youth to complete follow-up surveys. Strategies employed to overcome transportation challenges included shortening the number of sessions, offering sessions on both weekends and weekdays, and increasing bus tokens and transportation options. We hired more staff from American Indian/Alaska Native communities, added more research sites from our previously established relationships, and were more proactive in getting the word out on the project in American Indian/Alaska Native communities. We also utilized more field tracking and emailed and mailed survey invitations to reach more participants for their follow-up surveys. Because of our efforts, we were nearly able to reach our initial recruitment and retention goals.ConclusionAlthough our research team had previously established relationships with various urban American Indian/Alaska Native communities, we encountered various recruitment and retention challenges in our study. However, by identifying challenges and employing culturally appropriate strategies, we were able to collect valuable data on the potential effectiveness of a substance use prevention intervention for urban American Indian/Alaska Native adolescents. Findings from this study assist toward the development of potentially successful strategies to successfully recruit and retain urban American Indian/Alaska Native adolescents in randomized controlled trials.

Dataset Information

The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials.

Objective

Study design and setting

Results

Conclusion

Publications

The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials.

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