Power of an Effective Clinical Conversation: Improving Accrual Onto Clinical Trials

Parreco, Linda K.; DeJoice, Rhonda W.; Massett, Holly A.; Padberg, Rose Mary; Thakkar, Sona

doi:10.1200/jop.2011.000478

Cited by 10 publications

(6 citation statements)

References 29 publications

(18 reference statements)

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“…A portion of this information is consistent with the recommendations provided by the literature on clinical trials accrual [5,9,54]. However, the choice of topics differed across the trainings, and not all key areas were reported as having been covered.…”

Section: Discussionsupporting

confidence: 68%

“…Research on the reasons for clinical trials' low accrual rates has identified several key barriers, which include a low rate of physicians' referral [7,8]. Many physicians characterize discussions about research and clinical trials with patients as particularly challenging, a problem, which is rarely addressed, even by academic medical centers committed to the research enterprise [9].…”

mentioning

confidence: 99%

“…In fact, clinical and medical research teams are typically composed of a heterogeneous group of professionals with specific skills and roles; these include study nurses, clinical research coordinators, research associates, nonstudy personnel, and professional recruiters [9]. Regardless of the role, however, good communication skills are necessary to meet the needs of both patients and PIs to ensure both information comprehension and accrual [10,11].…”

mentioning

confidence: 99%

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Training Programs for Improving Communication about Medical Research and Clinical Trials: A Systematic Review

Occa¹,

Morgan²

2018

Clinical Trials in Vulnerable Populations

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Objectives: The aim of this article is to provide recommendations on the structure, materials, and outcomes that should be adopted for communication training programs designed to improve clinical trial education for patients. Methods:A systematic review of peer-reviewed articles was conducted. A total of 22 studies were included. Several dimensions were analyzed, such as program design, content development, pedagogical tools, content of the program, and the outcomes affected. Results:The trainings described in the articles analyzed generally took the form of workshops and were developed by groups of heterogeneous experts. Trainings used a variety of educational materials and activities often developed by the research team hosting the training. The outcome measures and assessment methods were not consistent among the trainings, which hinders the ability to statistically synthetize findings. Conclusions:Findings from the review point to a number of recommendations for the development of future clinical research communication training programs. Training programs should be developed by a team of experts with a range of expertise and should be organized in the form of workshops. Participants should be able to role-play newly acquired communication skills using standardized patients.

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Section: Discussionsupporting

confidence: 68%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Training Programs for Improving Communication about Medical Research and Clinical Trials: A Systematic Review

Occa¹,

Morgan²

2018

Clinical Trials in Vulnerable Populations

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“…Patient‐provider conversations are often the crucial moment when a patient decides whether to participate in a study (Parreco et al . ). Developing a best practices guide may be helpful to avoid these common barriers to recruitment in future studies.…”

Section: Discussionmentioning

confidence: 97%

Refusal to participate in heart failure studies: do age and gender matter?

Harrison

Jung

Lennie

et al. 2016

Journal of Clinical Nursing

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Aims and objectives The objective of this retrospective study was to evaluate reasons heart failure patients decline study participation, to inform interventions to improve enrollment. Background Failure to enrol older heart failure patients (age > 65) and women in studies may lead to sampling bias, threatening study validity. Design This study was a retrospective analysis of refusal data from four heart failure studies that enrolled 788 patients in four states. Methods Chi-Square and a pooled t-test were computed to analyse refusal data (n = 300) obtained from heart failure patients who were invited to participate in one of the four studies but declined. Results Refusal reasons from 300 patients (66% men, mean age 65 33) included: not interested (n = 163), too busy (n = 64), travel burden (n = 50), too sick (n = 38), family problems (n = 14), too much commitment (n = 13) and privacy concerns (n = 4). Chi-Square analyses showed no differences in frequency of reasons (p > 0 05) between men and women. Patients who refused were older, on average, than study participants. Conclusions Some reasons were patient-dependent; others were study-dependent. With ‘not interested’ as the most common reason, cited by over 50% of patients who declined, recruitment measures should be targeted at stimulating patients’ interest. Additional efforts may be needed to recruit older participants. However, reasons for refusal were consistent regardless of gender. Relevance to clinical practice Heart failure researchers should proactively approach a greater proportion of women and patients over age 65. With no gender differences in type of reasons for refusal, similar recruitment strategies can be used for men and women. However, enrolment of a representative proportion of women in heart failure studies has proven elusive and may require significant effort from researchers. Employing strategies to stimulate interest in studies is essential for recruiting heart failure patients, who overwhelmingly cited lack of interest as the top reason for refusal.

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“…Furthermore, slow enrollment in clinical studies may also lead to a delay in the availability of new therapies and, therefore, slow the advancement of medical progress [2]. For example, a year delay in access to Herceptin would represent a total loss of $8 billion dollars of benefit for breast cancer patients in the United States [3]. Development of reliable and practical tools for accrual prediction is critical in clinical trials.…”

Section: Introductionmentioning

confidence: 99%

Modeling and validating Bayesian accrual models on clinical data and simulations using adaptive priors

Jiang

Simon

Mayo

et al. 2014

Statistics in Medicine

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Slow recruitment in clinical trials leads to increased costs and resource utilization, which includes both the clinic staff and patient volunteers. Careful planning and monitoring of the accrual process can prevent the unnecessary loss of these resources. We propose two hierarchical extensions to the existing Bayesian constant accrual model: the accelerated prior and the hedging prior. The new proposed priors are able to adaptively utilize the researcher’s previous experience and current accrual data to produce the estimation of trial completion time. The performance of these models, including prediction precision, coverage probability, and correct decision-making ability, is evaluated using actual studies from our cancer center and simulation. The results showed that a constant accrual model with strongly informative priors is very accurate when accrual is on target or slightly off, producing smaller mean squared error, high percentage of coverage, and a high number of correct decisions as to whether or not continue the trial, but it is strongly biased when off target. Flat or weakly informative priors provide protection against an off target prior, but are less efficient when the accrual is on target. The accelerated prior performs similar to a strong prior. The hedging prior performs much like the weak priors when the accrual is extremely off target, but closer to the strong priors when the accrual is on target or only slightly off target. We suggest improvements in these models and propose new models for future research.

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Power of an Effective Clinical Conversation: Improving Accrual Onto Clinical Trials

Cited by 10 publications

References 29 publications

Training Programs for Improving Communication about Medical Research and Clinical Trials: A Systematic Review

Training Programs for Improving Communication about Medical Research and Clinical Trials: A Systematic Review

Refusal to participate in heart failure studies: do age and gender matter?

Modeling and validating Bayesian accrual models on clinical data and simulations using adaptive priors

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