Influence of Clinical Communication on Patients' Decision Making on Participation in Clinical Trials

Albrecht, Terrance L.; Eggly, Susan; Gleason, Marci E. J.; Harper, Felicity W. K.; Foster, Tanina; Peterson, Amy M.; Orom, Heather; Penner, Louis A.; Ruckdeschel, John C.

doi:10.1200/jco.2007.14.8114

Cited by 217 publications

(198 citation statements)

References 36 publications

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“…However, Bower and colleagues [11] highlighted that there was also a need to develop effective interventions aimed at those recruiting to trials. Although patient information leaflets are strictly regulated by ethics committees, the communication style of the recruiter (usually a clinician or nurse) plays an important role in patients' understanding of the information and their willingness to join the study [12]. Research has shown that information conveyed during recruitment appointments varies considerably in content and quality [13], and patients often have a poor understanding of RCT concepts [14][15][16][17].…”

Section: Introductionmentioning

confidence: 99%

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

et al. 2017

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Context: The importance of evidence from randomised trials is now widely recognised, although recruitment is often difficult. Qualitative research has shown promise in identifying the key barriers to recruitment, and interventions have been developed to reduce organisational difficulties and support clinicians undertaking recruitment. Objective: This article provides an introduction to qualitative research techniques and explains how this approach can be used to understand-and subsequently improverecruitment and informed consent within a range of clinical trials. Evidence acquisition: A literature search was performed using Medline, Embase, and CINAHL. All studies with qualitative research methods that focused on the recruitment activity of clinicians were included in the review. Evidence synthesis: The majority of studies reported that organisational difficulties and lack of time for clinical staff were key barriers to recruitment. However, a synthesis of qualitative studies highlighted the intellectual and emotional challenges that arise when combining research with clinical roles, particularly in relation to equipoise and patient eligibility. To support recruiters to become more comfortable with the design and principles of randomised controlled trials, interventions have been developed, including the QuinteT Recruitment Intervention, which comprises in-depth investigation of recruitment obstacles in real time, followed by implementation of tailored strategies to address these challenges as the trial proceeds. Conclusions: Qualitative research can provide important insights into the complexities of recruitment to trials and inform the development of interventions, and provide support and training initiatives as required. Investigators should consider implementing such methods in trials expected to be challenging or recruiting below target. Patient summary: Qualitative research is a term used to describe a range of methods that can be implemented to understand participants' perspectives and behaviours. Data are gathered from interviews, focus groups, or observations. In this review, we demonstrate how this approach can be used to understand-and improve-recruitment to clinical trials. Taken together, our review suggests that healthcare professionals can find recruiting to trials challenging and require support with this process.

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Section: Introductionmentioning

confidence: 99%

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

et al. 2017

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“…Poor BBN may have a negative impact on patients' satisfaction with care [1], adherence to treatment [2], decisions about treatment options [3] and psychological adjustment [4]. Reviews about BBN have been published and there is now a wide consensus that BBN requires specific communication skills.…”

Section: Introductionmentioning

confidence: 99%

The effect of communication skills training on residents’ physiological arousal in a breaking bad news simulated task

Meunier

Merckaert

Libert

et al. 2013

Patient Education and Counseling

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“…Patients prefer the doctor to make the treatment decisions rather than to be randomised. A recent report emphasises the influence of physicians' clinical communication on patients' decision-making on participation in clinical trials (Albrecht et al, 2008). Improving communication and more interventions by clinical research coordinators and other medical staff members in all eligible patients may improve the accrual rate (Fallowfield et al, 1998;Wright et al, 2004;Stryker et al, 2006).…”

Section: Discussionmentioning

confidence: 99%

“…The results of questionnaire surveys administered to patients regarding clinical trials revealed that two of the most common reasons for entering the trial were the hope for personal benefit and the opportunity to contribute to the research knowledge thereby benefiting others in the future (Jenkins and Fallowfield, 2000;Madsen et al, 2000Madsen et al, , 2002Ellis et al, 2001;Wright et al, 2004;Albrecht et al, 2008). On the other hand, the common reasons for declining participation were worries about the process of randomisation, overestimation of the benefits of standard therapy and fear of the trial's experimental nature (Jenkins and Fallowfield, 2000;Ellis et al, 2001;Ho et al, 2006).…”

mentioning

confidence: 99%

“…A number of studies have examined the motivations of patients for accepting or declining entry to RCTs (Jenkins and Fallowfield, 2000;Madsen et al, 2000Madsen et al, , 2002Ellis et al, 2001;Wright et al, 2004;Ho et al, 2006;Albrecht et al, 2008). The results of questionnaire surveys administered to patients regarding clinical trials revealed that two of the most common reasons for entering the trial were the hope for personal benefit and the opportunity to contribute to the research knowledge thereby benefiting others in the future (Jenkins and Fallowfield, 2000;Madsen et al, 2000Madsen et al, , 2002Ellis et al, 2001;Wright et al, 2004;Albrecht et al, 2008).…”

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confidence: 99%

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Characteristics and outcomes of patients with advanced non-small-cell lung cancer who declined to participate in randomised clinical chemotherapy trials

Tanai

Nokihara

Yamamoto³

et al. 2009

Br J Cancer

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There are inadequate data on the outcomes of patients who declined to participate in randomised clinical trials as compared with those of participants. We retrospectively reviewed the patient characteristics and treatment outcomes of both participants and non-participants in the two randomised trials for chemotherapy-naive advanced non-small-cell lung cancer. Trial 1 compared four platinum-based combination regimens. Trial 2 compared two sequences of carboplatin plus paclitaxel and gefitinib therapies. Nineteen of 119 (16%) and 153 (37%) patients declined to participate in Trials 1 and 2, respectively. Among the background patient characteristics, the only variable associated with trial participation or declining was the patients' attending physicians (Po0.001). Important differences were not observed in the clinical outcomes between participants and non-participants, for whom the response rates were 30.6 vs 34.2% and the median survival times were 489 vs 461 days, respectively. The hazard ratio for overall survival, adjusted for other confounding variables, was 0.965 (95% confidence interval: 0.73 -1.28). In conclusion, there was no evidence to suggest any difference in the characteristics and clinical outcomes between participants and non-participants. Trial designs and the doctor -patient relationship may have an impact on the patient accrual to randomised trials.

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Influence of Clinical Communication on Patients' Decision Making on Participation in Clinical Trials

Cited by 217 publications

References 36 publications

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

The effect of communication skills training on residents’ physiological arousal in a breaking bad news simulated task

Characteristics and outcomes of patients with advanced non-small-cell lung cancer who declined to participate in randomised clinical chemotherapy trials

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