What do our patients understand about their trial participation? Assessing patients' understanding of their informed consent consultation about randomised clinical trials

Behrendt, Carolyn E.; Gölz, Tanja; Roesler, Célia Aparecida de Paula; Bertz, Hartmut; Wünsch, Alexander

doi:10.1136/jme.2010.035485

Cited by 66 publications

(55 citation statements)

References 23 publications

(21 reference statements)

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“…More robust studies are needed to assess the effectiveness of training programmes, although these will need to give careful consideration to how ''successful'' interventions should be defined (ie, completion of study or evidence to support closure) and what the outcomes should be (ie, screening and eligibility counts, recruitment rates, or changes in informed consent). Furthermore, given that research has demonstrated that patients can find RCT concepts confusing [14][15][16][17], it is important not to neglect the patient's perspective of the recruitment process, and to further develop methods to facilitate joint decision making and ensure fully informed consent.…”

Section: Future Directions For Researchmentioning

confidence: 99%

“…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]. A systematic review of interventions to improve the recruitment activity of clinicians reported that the most promising interventions were studies that used qualitative research to identify key issues and develop interventions to improve recruitment [18].…”

Section: Introductionmentioning

confidence: 99%

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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: Future Directions For Researchmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2017

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“…There is little in the literature to describe health professionals' attitudes to choice of venous access devices. Quantitative studies indicate that whilst factors such as cost, durability and ease of use for medical personnel all feature in device decision making, little or no consideration is given to participants' views or preferences (26,27). The need for more studies to investigate the issue of patient satisfaction and quality of life in relation to venous access devices has been highlighted (28).…”

Section: Methodsmentioning

confidence: 99%

Exploring Attitudes towards a Randomised Controlled Trial of Venous access Devices – a Nested Pre-trial Qualitative Study

et al. 2015

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Purpose: This pre-trial qualitative research study was carried out to explore patient and clinical staff attitudes to central venous access devices (CVADs). In addition, views about participation in a randomised controlled trial (RCT) were explored with the aim of maximising recruitment to an imminent RCT of three CVADs. Methods: Three patient focus groups (each comprising three patients) and 23 interviews with clinical staff were conducted. Interviews and focus group discussions were digitally recorded, transcribed verbatim, anonymised, uploaded to the QSR NVivo10 qualitative software programme and thematically analysed. Results: Analysis of focus group interviews revealed the added challenges that a CVAD poses to patients with cancer. Four key themes emerged: continuity of daily life, pain and discomfort, stigma (a mark of disgrace associated with certain conditions) and self-preservation. The findings show the impact of a CVAD on patients' ability to manage their condition. Clinical staff interviews highlighted several potential barriers to recruitment; a lack of equipoise (genuine clinical uncertainty as to which intervention is the most beneficial), concerns about the logistics of device insertion and a perceived requirement for education and training. Conclusions: This qualitative study raises awareness of key areas of concern to patients who need a CVAD for chemotherapy delivery. It was identified that there is a need for clearer patient information around CVADs. Additionally it allows investigators to identify barriers to recruitment in a timely manner in order to minimise the potential for conflict between the roles of carer and researcher and consequently, maximise recruitment to the RCT. Keywords: Cancer, Health professionals' attitudes, Patient attitudes, Qualitative research, Randomised controlled trials, Venous access devices. BackgroundThis paper presents the results of a nested pre-trial qualitative research study carried out to inform a randomised controlled trial (RCT) of central venous access devices (CVADs). Qualitative and quantitative research are the two main research paradigms; whilst quantitative research tends to use numerical data, qualitative research uses language data either in the written or oral form (1). The value of utilising a mixture of quantitative and qualitative methods in developing and evaluating complex interventions is highlighted in recent Medical Research Council Guidance (2) and funders increasingly expect to see a qualitative research component incorporated in a study design. A nested qualitative study in a larger RCT serves to provide in-depth, explanatory

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“…In the context of research, this places a responsibility on investigators to provide potential participants full and accurate information and to ensure that their study processes promote individual participants' understanding and ability to choose freely (Behrendt, Gölz, Roesler, Bertz, & Wünsch, 2011). Researchers must take extra care when potential participants are subjected to compulsion in other aspects of their lives (Edens, Epstein, Stiles, & Poythress, 2011;Wolbransky, Goldstein, Giallella, & Heilbrun, 2013).…”

Section: Literature Regarding Informed Consent and The Context Of Thementioning

confidence: 99%

“…Obtaining consent that is fully informed and voluntary can be resource-intensive and, in some cases, problematic (Behrendt et al, 2011). There can also be various circumstances where seeking consent is impractical or impossible, such as in the delivery of emergency medical intervention (Appelbaum, Roth, & Lidz, 1982;Edwards et al, 2002;Mason & Allmark, 2000), or in the case of using stored data or materials after participants have left an institution (Tu et al, 2004).…”

Section: Literature Regarding Informed Consent and The Context Of Thementioning

confidence: 99%

Randomisation before consent: avoiding delay to time-critical intervention and ensuring informed consent

Welch

Turner-Halliday

Watson

et al. 2016

International Journal of Social Research Methodology

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Obtaining informed consent can be challenging in stressful and urgent circumstances. One example is when potential participants have recently had their child removed into care; intervention is urgent and mandatory whereas participation in associated research is voluntary. Using a nested qualitative study, we examined experiences of consent processes in a randomised controlled trial (RCT) of a family assessment and intervention service for maltreated young children. Some potential participants found it difficult to use information; some believed consenting might influence the return of their child. In response to these ethical challenges, we propose reversing the typical process of securing consent, so that randomisation to an intervention occurs before inviting potential participants to consider the trial. This will avoid delays, delineate research from intervention, and make it easier to consider information. We suggest that this innovation could be useful in trials across service areas that incorporate urgent and complex interventions.

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What do our patients understand about their trial participation? Assessing patients' understanding of their informed consent consultation about randomised clinical trials

Cited by 66 publications

References 23 publications

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

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

Exploring Attitudes towards a Randomised Controlled Trial of Venous access Devices – a Nested Pre-trial Qualitative Study

Randomisation before consent: avoiding delay to time-critical intervention and ensuring informed consent

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