Publications by authors named "Rebecca D Pentz"

77 Publications

Allocating Scarce Health Care Resources During Pandemics: Making the Case for Patients with Advanced and Metastatic Cancer.

Oncologist 2020 10 27;25(10):e1586-e1588. Epub 2020 Aug 27.

Winship Cancer Institute of Emory University, Atlanta, Georgia, USA.

The oncology community is concerned that patients with cancer will be unfairly classified in pandemic allocation guidance. Past guidance either excluded patients with metastatic cancer from consideration or categorized them as having a survival of less than 1 year. Given recent improvements in treatments, we recommend that the prognosis of an individual patient with cancer be determined with input from a cancer specialist or, if this is impractical, that the presence of active metastatic solid cancer or relapsed hematologic malignancy is graded as a major comorbidity, with a likelihood that survival will be less than 5 years; severe limitation in physical functioning (3 or 4 on the Eastern Cooperative Oncology Group performance status) would define a patient with advanced cancer as having a severe comorbidity, with a likelihood of less than 1 year of survival. Cancer may be the "Emperor of all Maladies," but it is no longer a certain death sentence.
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http://dx.doi.org/10.1634/theoncologist.2020-0442DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7436378PMC
October 2020

Patient and Surrogate Postenrollment Perspectives on Research Using the Exception From Informed Consent: An Integrated Survey.

Ann Emerg Med 2020 09 21;76(3):343-349. Epub 2020 May 21.

Emory University School of Medicine, Atlanta, GA; Emory University Rollins School of Public Health, Atlanta, GA.

Study Objective: It is important for researchers interested in trials using the exception from informed consent to understand the views and experiences of enrolled individuals. Previous studies have shown that patient and surrogate attitudes are generally positive. These studies were small and did not include pediatric patients, and interviews were often conducted long after trial enrollment. This study sought to explore attitudes toward exception from informed consent in a larger sample and more contemporaneous setting.

Methods: A 10-item paper-and-pencil survey was integrated into the Established Status Epilepticus Treatment Trial, a randomized trial of 3 treatments for benzodiazepine-refractory status epilepticus in pediatric and adult patients. Primary domains included attitudes toward trial enrollment, exception from informed consent, and community consultation. Simple descriptive statistics, χ, and Fisher's exact tests were conducted.

Results: Of 317 patients and surrogates, 90% agreed with or were neutral about the statement "I am glad that I/my family member was included in the Established Status Epilepticus Treatment Trial research study," whereas 10% disagreed. Twenty-seven percent disagreed with enrollment in the study without prospective consent. Black participants were more likely than white, other race, and unknown-race participants to disagree with enrollment without prospective consent (36% versus 23%, 14%, and 14%, respectively). Participants indicated that patients (81%), their families (65%), and those at risk for seizures (51%) were most important to include in community consultation.

Conclusion: This study aimed to explore attitudes toward exception from informed consent enrollment among participants at all sites in a large, multicenter exception from informed consent trial. General acceptance of trial enrollment was high; acceptance of exception from informed consent specifically was somewhat lower, especially among black participants. Our findings provide further support for targeted community consultation focusing on individuals with connections to the disease under study. Future research should focus on communication in the postenrollment period, especially with individuals who may have concerns about exception from informed consent.
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http://dx.doi.org/10.1016/j.annemergmed.2020.03.017DOI Listing
September 2020

Provider Recommendations for Phase I Clinical Trials Within a Shared Decision-Making Model in Phase I Cancer Clinical Trial Discussions.

JCO Oncol Pract 2020 Sep 19;16(9):e859-e867. Epub 2020 May 19.

Winship Cancer Institute, Atlanta, GA.

Purpose: Debate continues over whether explicit recommendations for a clinical trial should be included as an element of shared decision making within oncology. We aimed to determine if and how providers make explicit recommendations in the setting of phase I cancer clinical trials.

Methods: Twenty-three patient/provider conversations about phase I trials were analyzed to determine how recommendations are made and how the conversations align with a shared decision-making framework. In addition, 19 providers (9 of whose patient encounters were observed) were interviewed about the factors they consider when deciding whether to recommend a phase I trial.

Results: We found that providers are comprehensive in the factors they consider when recommending clinical trials. The two most frequently stated factors were performance status (89%) and patient preferences (84%). Providers made explicit recommendations in 19 conversations (83%), with 12 of those being for a phase I trial (12 [63%] of 19). They made these recommendations in a manner consistent with a shared decision-making model; 18 (95%) of the 19 conversations during which a recommendation was made included all steps, or all but 1 step, of shared decision making, as did 11 of the 12 conversations during which a phase I trial was recommended. In 7 (58%) of these later conversations, providers also emphasized the importance of the patient's opinion.

Conclusion: We suggest that providers not hesitate to make explicit recommendations for phase I clinical trials, because they are able to do so in a manner consistent with shared decision making. With further research, these results can be applied to other clinical trial settings.
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http://dx.doi.org/10.1200/JOP.19.00772DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7489480PMC
September 2020

Partnering With Patients to Bridge Gaps in Consent for Acute Care Research.

Am J Bioeth 2020 06;20(5):7-17

Emory University Winship Cancer Institute.

Clinical trials for acute conditions such as myocardial infarction and stroke pose challenges related to informed consent due to time limitations, stress, and severe illness. Consent processes should be sensitive to the context in which trials are conducted and to needs of patients and surrogate decision-makers. This manuscript describes a collaborative effort between ethicists, researchers, patients, and surrogates to develop patient-driven, patient-centered approaches to consent for clinical trials in acute myocardial infarction and stroke.Our group identified important ways in which existing consent processes and forms for clinical trials fail to meet patients' and surrogates' needs in the acute context. We collaborated to create model forms and consent processes that are substantially shorter and, hopefully, better-matched to patients' and surrogates' needs and expectations from the perspective of content, structure, and tone. These changes, however, challenge some common conventions regarding consent.
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http://dx.doi.org/10.1080/15265161.2020.1745931DOI Listing
June 2020

Cancer Research Ethics and COVID-19.

Oncologist 2020 06 30;25(6):458-459. Epub 2020 Mar 30.

Winship Cancer Institute, Emory School of Medicine, Atlanta, Georgia, USA.

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http://dx.doi.org/10.1634/theoncologist.2020-0221DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7228207PMC
June 2020

Ethics in Eye Banking: Understanding Professional Attitudes Toward Industry Changes.

Cornea 2020 Oct;39(10):1207-1214

School of Medicine, Emory University, Atlanta, GA.

Purpose: To describe the ethical attitudes of corneal surgeons and eye bank leadership toward for-profit entities in corneal donation, processing, and distribution.

Methods: Fifty postfellowship corneal surgeons practicing in the United States and 25 eye bank leaders (eg, eye bank directors, CEOs, or presidents) for the Eye Bank Association of America-accredited eye banks completed a 22-question interview, focusing on corneal donation industry changes, including the entry of for-profit institutions.

Results: Most participants in both study groups agreed that they have concerns with the entry of for-profit businesses into eye banking (62% corneal surgeons, 68% eye bank leadership), although physicians partnered with a for-profit corneal processor were significantly more likely to have no concerns with the entry of for-profits into eye banking than corneal surgeons partnered with a nonprofit processor (P = 0.04). The most frequently identified concerns with the entry of for-profit businesses into corneal banking were the hypothetical loss of donor trust (56% corneal surgeons, 64% eye bank leadership, P = 0.04) and the potential exploitation of donor generosity (72% corneal surgeons, 60% eye bank leadership). Qualitative theme analysis suggests that both study groups may view increased research/innovation as a potential benefit (64% corneal surgeons, 66% eye bank leadership) of for-profits in eye banking.

Conclusions: Key stakeholders in eye banking do hold relevant ethical beliefs toward recent industry changes, and these attitudes should be considered in the future creation of the ethical corneal donation policy. Further research is needed to assess the attitudes of potential donors and donor families.
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http://dx.doi.org/10.1097/ICO.0000000000002296DOI Listing
October 2020

Reply to Helping patients to understand terrifying news: Addressing the inner lives of physicians and extending beyond what we know.

Cancer 2020 06 19;126(11):2714-2716. Epub 2020 Feb 19.

Department of Hematology and Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia.

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http://dx.doi.org/10.1002/cncr.32766DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7265802PMC
June 2020

Why many oncologists fail to share accurate prognoses: They care deeply for their patients.

Cancer 2020 03 27;126(6):1163-1165. Epub 2019 Nov 27.

Department of Hematology and Oncology, Emory University School of Medicine, Atlanta, Georgia.

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http://dx.doi.org/10.1002/cncr.32635DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7050325PMC
March 2020

Determinants of Patient and Surrogate Experiences With Acute Care Research Consent: A Key Informant Interview Study.

J Am Heart Assoc 2019 11 8;8(22):e012599. Epub 2019 Nov 8.

Emory University School of Medicine Atlanta GA.

Background Informed consent for acute myocardial infarction and stroke research is challenging. Time for enrollment decisions is limited, patients and family are usually stressed, and being asked to participate in research is often unexpected. Despite these barriers, patients and surrogates have reported a preference for prospective involvement in research decisions and generally positive views of the consent process. It is unknown what drives positive or negative consent experiences. These data are crucial to making consent processes more context appropriate. Methods and Results We conducted a qualitative interview study with 27 patients and surrogates enrolled in acute myocardial infarction and stroke trials in the past 5 years. Purposive sampling from the P-CARE (Patient-Centered Approaches to Research Enrollment) study was based on participant characteristics and responses to initial patient-centered interviews. In-depth interviews used open-ended questions to explore factors influencing consent experiences. Qualitative descriptive analysis was performed utilizing a multilevel coding strategy. Participants identified specific researcher behaviors as important, including expressions of respect, professionalism, and nonpressuring communication. Participants preferred consent conversations focused on risks/benefits and the trial protocol. They had varying views of consent forms and communicated several reasons the form was valuable unrelated to informational content. Participants also valued postenrollment interactions as opportunities to ask questions and learn about the study. Conclusions Barriers to consent in acute myocardial infarction and stroke trials are unavoidable, but participants identified productive ways to demonstrate respect for patients during enrollment conversations. These include key researcher behaviors, concentrating consent discussions on what participants find most important, and structured postenrollment follow-up.
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http://dx.doi.org/10.1161/JAHA.119.012599DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6915273PMC
November 2019

Videos improve patient understanding of misunderstood chemotherapy terminology.

Cancer 2019 11 16;125(22):4011-4018. Epub 2019 Aug 16.

Department of Hematology and Oncology, Emory University School of Medicine, Atlanta, Georgia.

Background: Chemotherapy is the backbone of many cancer therapies; however, the terminology used to describe chemotherapy may be difficult for patients to understand, particularly in underserved populations. Studies have shown that educational videos can improve patient understanding of cancer-related terms. The goal of this study was to identify chemotherapy terms that were difficult for an underserved population to understand and then develop and test educational videos describing these terms.

Methods: A word bank of 50 difficult-to-understand chemotherapy terms was developed by querying 15 providers and 50 patients at an underserved hospital. Twenty of these terms were then tested with 50 additional patients to determine rates of misunderstanding. Six pilot educational videos describing 6 important terms were created using VideoScribe and then assessed with 50 patients to see if they improved understanding.

Results: Fifteen of the 20 terms tested to establish rates of misunderstanding were misunderstood by more than one third of patients, with 98% unable to define maintenance, 74% unable to define cancer, and 58% unable to define chemotherapy. Patient understanding of all 6 terms improved by at least 20% after watching the videos. Notable improvement was reported for palliative chemotherapy, where before-and-after video understanding increased from 0% to 72%.

Conclusion: Chemotherapy, a backbone of cancer treatment, is described with terms that are difficult to understand. Short, animated educational videos can significantly increase patient understanding of chemotherapy terminology.
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http://dx.doi.org/10.1002/cncr.32421DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6986301PMC
November 2019

The Impact of Genetic Counseling Educational Tools on Patients' Knowledge of Molecular Testing Terminology.

J Cancer Educ 2020 10;35(5):864-870

Emory University School of Medicine, 201 Dowman Dr., Atlanta, GA, 30322, USA.

Molecular testing is increasingly being integrated into cancer management. Despite rapid advancements, little work has been done to explore strategies for communicating with patients undergoing molecular tumor testing. This study evaluated the impact of genetic counseling educational tools on improving patients' understanding of key terms related to molecular testing. A genetic counseling intern designed a picture book to explain six words found in prior research to be difficult to understand (mutation, germline mutation, somatic mutation, biomarker, molecular testing, and targeted therapy). Participants who had previously discussed molecular testing with their oncologist were asked to define the terms. The same participants then received an explanation of each term either from the intern using the picture book in person or from a video presentation of the picture book. They were then asked to redefine each term afterward. The difference between the number of terms defined correctly pre- and post-intervention was compared between presentations. Sixty-three patients with melanoma, colon, lung, or breast cancer were recruited. After both interventions, correct understanding rates improved for all six terms, with significant improvement for germline mutation (p < 0.001), somatic mutation (p < 0.001), biomarker (p < 0.001), and molecular testing (p < 0.001). Understanding of targeted therapy improved significantly (p = 0.011) for the video presentation only. Mean change in knowledge scores did not differ between the two interventions (intern presentation 3.2 vs. video 2.9, p = 0.428). Our data suggest that genetic counseling educational tools can increase patient understanding of terms used to describe molecular testing.
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http://dx.doi.org/10.1007/s13187-019-01535-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6834865PMC
October 2020

Academic oncology clinicians' understanding of biosimilars and information needed before prescribing.

Ther Adv Med Oncol 2019 6;11:1758835918818335. Epub 2019 Jan 6.

Winship Cancer Institute, School of Medicine, Emory University, 1365B Clifton Road NE B4300, Atlanta, GA 30322, USA.

Background: With increasing numbers of oncology biosimilars in the approval pipeline, it is important to investigate oncology clinicians' understanding of biosimilars and what information they need prior to adoption.

Methods: Between January and May 2018, 77 oncology clinicians (52 physicians, 16 pharmacists, and 9 advanced practice providers) completed a survey covering three domains: clinician understanding, prescription preferences, and patient involvement. An in-depth interview was designed based on themes identified in the first 50 surveys: cost, safety and efficacy, patient preference, and disease stage. Participants were chosen to participate in the interview based on outlying responses to survey questions.

Results: When asked to define a biosimilar, 74% (57/77) of respondents could not give a satisfactory definition, and 40.3% (31/77) considered a biosimilar the same as a generic drug. The most important factor in biosimilar prescription was safety and efficacy (4.51 out of 5) followed closely by cost differences (4.34 out of 5). A 40% increase (53.2-94.8%) in clinicians' prescribing likelihood was seen after a biosimilar is designated as interchangeable. Participants in this study were split regarding the importance of shared decision-making with patients [50.7% (39/77) important or extremely important, 39.0% (30/77) somewhat or not at all important]. Clinicians were also split concerning the role that pharmacists should play in the decision to prescribe or substitute biosimilars.

Conclusion: Understanding of biosimilars is low, and educational needs are high. The information that clinicians deem important to assess, such as safety, efficacy and cost, will need to be provided before they are comfortable prescribing biosimilars.
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http://dx.doi.org/10.1177/1758835918818335DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6327341PMC
January 2019

Emergency Consent: Patients' and Surrogates' Perspectives on Consent for Clinical Trials in Acute Stroke and Myocardial Infarction.

J Am Heart Assoc 2019 01;8(2):e010905

3 Winship Cancer Institute Emory University School of Medicine Atlanta GA.

Background Emergent informed consent for clinical trials in acute myocardial infarction (AMI) and stroke is challenging. The role and value of consent are controversial, and insufficient data exist regarding patients' and surrogates' experiences. Methods and Results We conducted structured interviews with patients (or surrogates) enrolled in AMI or acute stroke trials at 6 sites between 2011 and 2016. Primary domains included trial recall, consent experiences, and preferences regarding involvement. Descriptive and test statistics were used to characterize responses and explore relationships between key domains and characteristics. Multivariable logistic regression was used to examine associations between key covariates and consent preferences. There were 176 (84 stroke, 92 AMI) completed interviews. Most stroke respondents (82%) were surrogates; all AMI respondents were patients. Average time from trial enrollment to interview was 1.9 years (stroke) and 2.8 years (AMI); 89% of stroke and 62% of AMI respondents remembered being in the trial, and among these respondents, 80% (stroke) and 44% (AMI) remembered reading some of the consent form. Over 90% reported not feeling pressure to enroll, being treated in a caring way, and being treated with dignity. A minority (16% stroke and 26% AMI) reported they would have preferred not to be asked for consent. Just over half (61% stroke and 53% AMI) recalled a postenrollment conversation about the study. Conclusions Most respondents felt they were treated respectfully and were glad they had been asked for consent. Trial recall was relatively low, and many respondents recalled little postenrollment discussion. Further development of context-sensitive approaches to consent is important.
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http://dx.doi.org/10.1161/JAHA.118.010905DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6497349PMC
January 2019

Ethical considerations of using a single minor donor for three bone marrow harvests for three HLA-matched siblings with primary immunodeficiency.

Pediatr Blood Cancer 2019 04 4;66(4):e27602. Epub 2019 Jan 4.

Duke University Medical Center, Durham, North Carolina.

Allogeneic hematopoietic stem cell transplantation is curative for primary immunodeficiencies. Bone marrow from an unaffected human leukocyte antigen (HLA)-identical sibling donor is the ideal graft source. For minor donors, meaningful consent or assent may not be feasible, and permission from parents or legal guardians is considered acceptable. Adverse events, albeit extremely small, can be associated with bone marrow harvest in pediatric donors. Donor safety concerns potentially increase with multiple bone marrow harvests. Very little is known about multiple bone marrow harvests from pediatric donors. We describe the ethical considerations and clinical decision-making in an unusual clinical situation where three patients with the same primary immunodeficiency were HLA identical to one another and their younger sibling, who underwent bone marrow harvests three times between 1.3 and 4 years of age, resulting in successful transplantation for all three patients. We hope that this experience will provide guidance to providers and families in a similar situation.
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http://dx.doi.org/10.1002/pbc.27602DOI Listing
April 2019

Potential Benefits to Families, Children, and Adolescents Enrolled in Longitudinal Qualitative Research.

IRB 2018 Jul-Aug;40(4):1-7

Emory School of Medicine.

Previous research has focused on the risks of research participation but has rarely considered possible benefits. For a study of family decision-making during pediatric bone marrow transplant, we conducted qualitative interviews with 132 family members across 36 families up to three times over the course of a year, before and after transplant. We concluded the study with qualitative interviews of 70 family members from 21 of the original families one year after the transplants, focusing on benefits and concerns regarding their research participation. Participants, including children and adolescents, reported benefits including the opportunity to talk, be altruistic, reflect, have a safe space, gain understanding or perspective, and express emotions. Sixteen percent expressed concerns, mostly finding aspects of the methodology annoying. We encourage institutional review boards to understand that sensitive conversations with adults, children or adolescents may not always increase the risk of the study and may offer benefits to those who agree to be interviewed. We therefore suggest that language describing potential benefits could be included in consent and assent forms for qualitative studies.
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January 2019

Caring for Colleagues and Loved Ones With Cancer.

Am Soc Clin Oncol Educ Book 2018 May;38:903-908

From the Winship Cancer Institute of Emory University, Atlanta, GA; Harbin Clinic LLC, Rome, GA; Sarah Cannon Cancer Institutes HCA Midwest Health, Overland Park, KS; Emory University School of Medicine, Atlanta, GA; Monash Medical Centre, Glen Waverley, Australia; University of Florida College of Medicine, Gainesville, FL.

Throughout the arc of a career in medicine, physicians are universally faced with the difficult decision of when to provide care for a colleague and when to refer to another physician. Gauging the magnitude of your relationship, both professionally and personally, and then weighing how to add the roles of physician and patient to your preexisting relationship is complex. We review and discuss care of family and colleagues, address ethical boundaries both firm and flexible, and explore the emotional weight of those relationships.
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http://dx.doi.org/10.1200/EDBK_201451DOI Listing
May 2018

Child and Parent Access to Transplant Information and Involvement in Treatment Decision Making.

West J Nurs Res 2019 04 12;41(4):576-591. Epub 2018 Apr 12.

7 Children's National Health System, Washington, DC, USA.

Pediatric stem cell transplant processes require information sharing among the patient, family, and clinicians regarding the child's condition, prognosis, and transplant procedures. To learn about perceived access to transplant information and involvement in decision making among child family members (9-22 years old), we completed a secondary analysis of 119 interviews conducted with pediatric patients, sibling donors, nondonor siblings/cousins, and guardians from 27 families prior to transplant. Perceptions of information access and involvement in transplant-related decisions were extracted and summarized. We compared child member perceptions to their guardians' and examined differences by child age and gender. Most child members perceived exclusion from transplant (79%) and donor (63%) information and decisions (63%) although this varied by child role. Gender was unrelated to involvement; older age was associated with less perceived exclusion. Congruence in perspectives across children and guardians was evident for eight (30%) families, most of whom ( n = 7) excluded the children.
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http://dx.doi.org/10.1177/0193945918770440DOI Listing
April 2019

Patient perspectives on compensation for biospecimen donation.

AJOB Empir Bioeth 2018 Apr-Jun;9(2):77-81. Epub 2018 Apr 26.

a Department of Hematology and Medical Oncology , Winship Cancer Institute, Emory University School of Medicine , Atlanta , Georgia , USA.

Background: The purpose of this study was to determine whether biospecimen donors believe they should receive compensation. This is the first study to report biospecimen donors' views on compensation and can potentially improve informed consent and recruitment practices.

Methods: Researchers asked patients undergoing surgical removal of tissue to donate biological materials to a biobank; the request was made at their presurgical appointment or in the preoperative clinic of the Emory University Hospital. We interviewed 126 biospecimen donors within 30 days post surgery regarding their perspective on compensation for biospecimen donation.

Results: In response to the question "Should you be paid for your participation in the tissue bank?," 95 (95/126, 75%) participants answered "No." Of these, 55 (55/95, 58%) indicated that donating biological materials should be about altruism, not gaining a monetary reward. Only 11 (11/126, 9%) participants unequivocally believed they should receive compensation, while 14 (14/126, 11%) felt entitled to compensation only under specific circumstances. Eleven (11/14) "Depends" participants indicated that donors should only be compensated when researchers perform for-profit research. Responses varied by race and income level, with whites more likely to not feel entitled to compensation and higher income participants more likely to respond "Depends."

Conclusions: The majority of biospecimen donors stated they should not be paid for tissue bank participation. However, a minority believe they should be paid for donating tissue if the tissue is used in revenue-generating projects. These results provide some support for the current biobanking practice of not providing compensation.
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http://dx.doi.org/10.1080/23294515.2018.1460633DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6299829PMC
November 2019

Broad Consent for Research on Biospecimens: The Views of Actual Donors at Four U.S. Medical Centers.

J Empir Res Hum Res Ethics 2018 04 1;13(2):115-124. Epub 2018 Feb 1.

7 Emory University School of Medicine, Atlanta, GA, USA.

Commentators are concerned that broad consent may not provide biospecimen donors with sufficient information regarding possible future research uses of their tissue. We surveyed with interviews 302 cancer patients who had recently provided broad consent at four diverse academic medical centers. The majority of donors believed that the consent form provided them with sufficient information regarding future possible uses of their biospecimens. Donors expressed very positive views regarding tissue donation in general and endorsed the use of their biospecimens in future research across a wide range of contexts. Concerns regarding future uses were limited to for-profit research and research by investigators in other countries. These results support the use of broad consent to store and use biological samples in future research.
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http://dx.doi.org/10.1177/1556264617751204DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5869128PMC
April 2018

Patient, caregiver and physician perspectives on participating in a thoracic rapid tissue donation program.

Patient Educ Couns 2018 04 28;101(4):703-710. Epub 2017 Nov 28.

Morsani College of Medicine, Department of Oncologic Science, University of South Florida, 12901 Bruce B Downs Blvd., Tampa, FL 33612, United States; Department of Thoracic Oncology, H. Lee Moffitt Cancer Center & Research Institute, 12902 Magnolia Drive, Tampa, FL 33612, United States.

Objective: The collection of posthumous tissue from advanced stage lung cancer patients is beneficial to medical science. Recruiting living patients to a Rapid Tissue Donation Program (RTD) poses several psychosocial challenges and little is known about perceptions of joining this type of program. This study qualitatively examined perceptions of advanced stage lung cancer patients (n=14) participating in a lung cancer RTD program, their NoK (n=11), and physicians (n=6) at the Thoracic Oncology Clinic at H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida USA.

Methods: Semi-structured interviews were conducted with participants and interview transcripts were analyzed using the constant comparison method.

Results: Majority of patients joined to give back to research, discussed participation with family members, and desired for family to receive information about the use of the tissue after their death. All participating NoK were supportive of their family member's decision. Physicians described the program as running smoothly, but provided suggestions for process improvements.

Conclusion: Participants joined with intention to give back to research community and families were supportive of loved one's participation in RTD. Physicians agreed with overall process.

Practice Implications: Key factors for a successful RTD program is tailoring to institutional and individual needs.
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http://dx.doi.org/10.1016/j.pec.2017.11.014DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5878993PMC
April 2018

Reframing Consent for Clinical Research: A Function-Based Approach.

Am J Bioeth 2017 12;17(12):3-11

d National Institutes of Health.

Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals.
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http://dx.doi.org/10.1080/15265161.2017.1388448DOI Listing
December 2017

Does experience matter? Implications for community consultation for research in emergency settings.

AJOB Empir Bioeth 2017 Apr-Jun;8(2):75-81. Epub 2017 Mar 24.

a Department of Medicine , Emory University School of Medicine , Atlanta , Georgia , USA.

Background: Community consultation (CC) is required for research in emergency settings using an exception from informed consent (EFIC) in the United States, but uncertainty persists regarding best CC practices. There is ongoing debate about whom to include in CC, specifically, whether to prioritize geographically defined communities or individuals with connections to the condition. Understanding the impact of personal disease experience on views of EFIC research is important for designing CC and interpreting its results.

Methods: This study was a secondary analysis of surveys administered to 2612 participants at 12 sites in CC events conducted for ProTECT III: Progesterone for Traumatic Brain Injury, a Phase III, randomized trial conducted using EFIC. Key survey domains included personal traumatic brain injury (TBI) experience, demographic information, and acceptance of both hypothetical personal enrollment under EFIC and the use of EFIC in general in ProTECT III. Descriptive statistics and multivariable regression models were used to explore relationships between key domains.

Results: TBI patients, those with family members/loved ones with TBI, and those who knew someone else with TBI were slightly more accepting of hypothetical personal enrollment under EFIC (adjusted odds ratio [OR] 1.14 [0.78-1.67], 1.54 [1.17-2.02], and 1.51 [1.19-1.92], respectively) and use of EFIC in general (adjusted OR 1.17 [0.83-1.64], 1.39 [1.08-1.77], and 1.06 [0.86-1.31], respectively) than those without this. In a subgroup analysis based on race, white participants with any disease experience had higher levels of acceptance of EFIC, as expected. However, there was numerically lower acceptance of personal and general EFIC enrollment among black participants with closer TBI connections.

Conclusions: Personal TBI experience was associated with increased acceptance of EFIC research for that condition, except among black participants. Heterogeneity of the effect of personal disease experience on EFIC views further supports inclusion of individuals with relevant disease experience in CC and highlights the importance of engaging minority participants.
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http://dx.doi.org/10.1080/23294515.2017.1308978DOI Listing
June 2018

Patient and Surrogate Views of Community Consultation for Emergency Research.

Acad Emerg Med 2017 11 23;24(11):1410-1414. Epub 2017 Oct 23.

Division of Cardiology, Atlanta, GA.

Objective: Pretrial community consultation (CC) is required for emergency research conducted under an exception from informed consent (EFIC) in the United States. CC remains controversial and challenging, and minimal data exist regarding the views of individuals enrolled in EFIC trials on this process. It is important to know whether participants perceive CC to be meaningful and, if so, whom they believe should be consulted.

Methods: We conducted a secondary analysis of data from two studies interviewing patients and surrogates of two recent EFIC trials (PEER-RAMPART and PEER-ProTECT). These interviews included similar open- and closed-ended questions regarding participants' views of the importance of CC, the rationale for their responses, and their views regarding which populations should be included in consultation efforts. A template analytic strategy was used for qualitative analysis of textual data, and descriptive statistics were tabulated to characterize demographic data and instances of major themes.

Results: Ninety percent of participants perceived CC to be valuable. Participants' reasons for finding CC valuable clustered in two categories: 1) as a method of informing the public about the trial to be conducted and 2) as a way of obtaining input and feedback from the community. Participants cited the medical community (43%) and individuals with a connection to the study condition (41%) as the most important groups to involve in consultation efforts; only 5% suggested consulting the general public in the area where the research will be conducted.

Conclusion: Participants in EFIC trials and their decision makers generally valued CC as a method of informing and seeking input from the community. Participants felt that the most appropriate groups to consult were the medical community and individuals with connections to the condition under study. Consultation efforts focused on these two groups, rather than the general public, may be more efficient and more meaningful to individuals involved in EFIC trials. These findings also reinforce the importance of the distinction between public disclosure and CC.
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http://dx.doi.org/10.1111/acem.13265DOI Listing
November 2017

Cancer donor preferences for disposition of their biospecimens after biobank closure.

Cancer 2017 Dec 26;123(23):4648-4652. Epub 2017 Jul 26.

Department of Hematology and Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia.

Background: Biobank funding is unstable and biobank administrators are concerned about loss of funding and subsequent biobank closure. Nevertheless, only a minority of biobanks have policies regarding the distribution or destruction of tissue if the biobank were to close. To the authors' knowledge, the current study is the first to report on the preferences of oncology biospecimen donors regarding the handling of their biospecimens in the event of biobank closure.

Methods: A total of 98 biospecimen donors who were diagnosed with cancer at the Georgia Cancer Center for Excellence at Grady Memorial Hospital or the Winship Cancer Institute were interviewed concerning their preferences for the handling of their biospecimens in the event of biobank closure.

Results: The majority of biospecimen donors who expressed a preference (62 of 83 donors; 75%) wanted their biological materials transferred to another biobank, specifically an academic bank or a national bank. The most unacceptable options for the handling of tissue were transfer to a for-profit/pharmaceutical biobank (39 of 98 donors; 40%) or a biobank based outside of the United States (31 of 98 donors; 32%). Nonwhite participants were more likely to view the transfer of their tissue to a for-profit/pharmaceutical tissue bank, international tissue bank, or a national tissue bank as unacceptable compared with white participants.

Conclusions: According to these biospecimen donors, the most acceptable options for the handling of biospecimens after biobank closure were transfer to an academic or national bank. The most objectionable options were transfer to a for-profit/pharmaceutical biobank or a biobank based outside of the United States. These findings can be used as the basis for educational interventions directed at the public and can inform the policies of biobanks that serve oncology research. Cancer 2017;123:4648-4652. © 2017 American Cancer Society.
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http://dx.doi.org/10.1002/cncr.30910DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5693705PMC
December 2017

Impact of individual clinical outcomes on trial participants' perspectives on enrollment in emergency research without consent.

Clin Trials 2017 Apr 15;14(2):180-186. Epub 2016 Nov 15.

11 Division of Cardiology, Department of Medicine, School of Medicine, Emory University, Atlanta, GA, USA.

Background: Evidence suggests that patients are generally accepting of their enrollment in trials for emergency care conducted under exception from informed consent. It is unknown whether individuals with more severe initial injuries or worse clinical outcomes have different perspectives. Determining whether these differences exist may help to structure post-enrollment interactions.

Methods: Primary clinical data from the Progesterone for the Treatment of Traumatic Brain Injury trial were matched to interview data from the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study. Answers to three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study were analyzed in the context of enrolled patients' initial injury severity (initial Glasgow Coma Scale and Injury Severity Score) and principal clinical outcomes (Extended Glasgow Outcome Scale and Extended Glasgow Outcome Scale relative to initial injury severity). The three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study addressed participants' general attitude toward inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial (general trial inclusion), their specific attitude toward being included in Progesterone for the Treatment of Traumatic Brain Injury trial under the exception from informed consent (personal exception from informed consent enrollment), and their attitude toward the use of exception from informed consent in the Progesterone for the Treatment of Traumatic Brain Injury trial in general (general exception from informed consent enrollment). Qualitative analysis of interview transcripts was performed to provide contextualization and to determine the extent to which respondents framed their attitudes in terms of clinical experience.

Results: Clinical data from Progesterone for the Treatment of Traumatic Brain Injury trial were available for all 74 patients represented in the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study (including 46 patients for whom the surrogate was interviewed due to the patient's cognitive status or death). No significant difference was observed regarding acceptance of general trial inclusion or acceptance of general exception from informed consent enrollment between participants with favorable neurological outcomes and those with unfavorable outcomes relative to initial injury. Agreement with personal enrollment in Progesterone for the Treatment of Traumatic Brain Injury trial under exception from informed consent, however, was significantly higher among participants with favorable outcomes compared to those with unfavorable outcomes (89% vs 59%, p = 0.003). There was also a statistically significant relationship between more severe initial injury and increased acceptance of personal exception from informed consent enrollment ( p = 0.040) or general exception from informed consent use ( p = 0.034) in Progesterone for the Treatment of Traumatic Brain Injury trial. Many individuals referenced personal experience as a basis for their attitudes, but these references were not used to support negative views.

Conclusion: Patients and surrogates of patients with unfavorable clinical outcomes were somewhat less accepting of their own inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial under exception from informed consent than were patients or surrogates of patients with favorable clinical outcomes. These findings suggest a need to identify optimal strategies for communicating with patients and their surrogates regarding exception from informed consent enrollment when clinical outcomes are poor.
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http://dx.doi.org/10.1177/1740774516677276DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5380144PMC
April 2017

Using Metaphors to Explain Molecular Testing to Cancer Patients.

Oncologist 2017 04 20;22(4):445-449. Epub 2017 Feb 20.

Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia, USA

Background: Molecular testing to identify targetable molecular alterations is routine practice for several types of cancer. Explaining the underlying molecular concepts can be difficult, and metaphors historically have been used in medicine to provide a common language between physicians and patients. Although previous studies have highlighted the use and effectiveness of metaphors to help explain germline genetic concepts to the general public, this study is the first to describe the use of metaphors to explain molecular testing to cancer patients in the clinical setting.

Methods: Oncologist-patient conversations about molecular testing were recorded, transcribed verbatim, and coded. If a metaphor was used, patients were asked to explain it and assess its helpfulness.

Results: Sixty-six patients participated. Nine oncologists used metaphors to describe molecular testing; 25 of 66 (38%) participants heard a metaphor, 13 of 25 (52%) were questioned, 11 of 13 (85%) demonstrated understanding and reported the metaphor as being useful. Seventeen metaphors (bus driver, boss, switch, battery, circuit, broken light switch, gas pedal, key turning off an engine, key opening a lock, food for growth, satellite and antenna, interstate, alternate circuit, traffic jam, blueprint, room names, Florida citrus) were used to explain eight molecular testing terms (driver mutations, targeted therapy, hormones, receptors, resistance, exon specificity, genes, and cancer signatures).

Conclusion: Because metaphors have proven to be a useful communication tool in other settings, these 17 metaphors may be useful for oncologists to adapt to their own setting to explain molecular testing terms. 2017;22:445-449 This article provides a snapshot of 17 metaphors that proved useful in describing 8 complicated molecular testing terms at 3 sites. As complex tumor sequencing becomes standard of care in clinics and widely used in clinical research, the use of metaphors may prove a useful communication tool, as it has in other settings. Although this study had a small sample, almost all of the patients who were exposed to metaphors in explaining molecular testing reported it as being helpful to their understanding. These 17 metaphors are examples of potentially useful communication tools that oncologists can adapt to their own practice.
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http://dx.doi.org/10.1634/theoncologist.2016-0270DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5388373PMC
April 2017

Discussing molecular testing in oncology care: Comparing patient and physician information preferences.

Cancer 2017 05 31;123(9):1610-1616. Epub 2017 Jan 31.

Department of Hematology and Oncology, Winship Cancer Institute, Atlanta, Georgia.

Background: Molecular testing to inform treatment and clinical trial choices is now the standard of care for several types of cancer. However, no established guidelines exist for the type of information physicians should cover during discussions with the patient about the test or its results. The objectives of this study were to identify physician and patient preferences regarding information and who should communicate this information and how to inform guidelines for these conversations.

Methods: Physicians and patients who participated in discussions regarding molecular testing were asked to choose 8 topics of most relevance out of a list of 18. The McNemar test was used to determine their top preferences. Patients were asked to identify what information they wanted to receive and who should inform them, and physicians were asked to identify the best aid to communication.

Results: Sixty-six patients identified 12 preferred topics: the benefits of testing (88%), how testing determines treatment (88%), implications for family (71%), whether a test indicates the seriousness of disease (68%), purpose of the test (64%), incidental findings (56%), explanation of cancer genetics (53%), how the test is done (46%), limitations (44%), explanation of biomarker (42%), risks (42%), and uninformative results (38%). Physicians added cost (59%). Patients preferred receiving information about molecular testing from their nurse or physician (85%), and physicians preferred using a pamphlet (67%) to augment communication.

Conclusions: The topics identified as important to discuss can inform future guidelines and can contribute to effective communication regarding molecular testing. Cancer 2017;123:1610-1616. © 2017 American Cancer Society.
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http://dx.doi.org/10.1002/cncr.30494DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5400669PMC
May 2017

Family Strategies to Support Siblings of Pediatric Hematopoietic Stem Cell Transplant Patients.

Pediatrics 2017 Feb;139(2)

Department of Hematology and Oncology, Emory School of Medicine, and

Objective: To describe the strategies families report using to address the needs and concerns of siblings of children, adolescents, and young adults undergoing hematopoietic stem cell transplant (HSCT).

Methods: A secondary semantic analysis was conducted of 86 qualitative interviews with family members of children, adolescents, and young adults undergoing HSCT at 4 HSCT centers and supplemented with a primary analysis of 38 additional targeted qualitative interviews (23 family members, 15 health care professionals) conducted at the primary center. Analyses focused on sibling issues and the strategies families use to address these issues.

Results: The sibling issues identified included: (1) feeling negative effects of separation from the patient and caregiver(s); (2) experiencing difficult emotions; (3) being faced with additional responsibilities or burdens; (4) lacking information; and (5) feeling excluded. Families and health care providers reported the following strategies to support siblings: (1) sharing information; (2) using social support and help offered by family or friends; (3) taking siblings to the hospital; (4) communicating virtually; (5) providing special events or gifts or quality time for siblings; (6) offering siblings a defined role to help the family during the transplant process; (7) switching between parents at the hospital; (8) keeping the sibling's life constant; and, (9) arranging sibling meetings with a certified child life specialist or school counselor.

Conclusions: Understanding the above strategies and sharing them with other families in similar situations can begin to address sibling issues during HSCT and can improve hospital-based, family-centered care efforts.
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http://dx.doi.org/10.1542/peds.2016-1057DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5260146PMC
February 2017

Access to Children's Oncology Group and Pediatric Brain Tumor Consortium phase 1 clinical trials: Racial/ethnic dissimilarities in participation.

Cancer 2016 Oct 12;122(20):3207-3214. Epub 2016 Jul 12.

Winship Cancer Institute, Atlanta, Georgia.

Background: Phase 1 clinical trials introduce new therapies to humans with the goal of establishing their safety. A prior Children's Oncology Group (COG) study analyzed the proportional enrollment of patients by race, ethnicity, sex, and age for all trial phases. The current study evaluated the representation of patients by race, ethnicity, sex, and age in phase 1 clinical trials.

Methods: This study evaluated 1348 children with 128 diagnoses enrolled in COG and Pediatric Brain Tumor Consortium phase 1 clinical trials in the United States from February 28, 2000 to December 29, 2008. Observed and expected proportions were calculated according to an established methodology with a representative population from Surveillance, Epidemiology, and End Results data, which included 27,766 children with the same International Classification of Diseases for Oncology (third edition) diagnostic codes.

Results: Underrepresentation in phase 1 trials was seen for lymphohematopoietic (LH) tumors (9.3% observed vs 37% expected) versus solid tumors (90.6% observed vs 63% expected). Although representation was fairly proportional, Hispanics (12.6% observed vs 27% expected), particularly Hispanic females (6% observed vs 18% expected), were significantly underrepresented. The 0- to 4-year age group was underrepresented (11.7% observed vs 36.5% expected). By tumor type, the most significantly underrepresented groups were 0- to 4-year-old children and Hispanics for both solid cancers (11% observed vs 34.4% expected for 0- to 4-year-old children and 12% observed vs 24% expected for Hispanics) and LH cancers (16% observed vs 40% expected for 0- to 4-year-old children and 19.4% observed vs 33% expected for Hispanics).

Conclusions: Although sex and racial/ethnic groups are mostly proportionally represented in phase 1 trials, some specific subgroups such as Hispanic children are underrepresented and may benefit from focused accrual. Cancer 2016;122:3207-14. © 2016 American Cancer Society.
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http://dx.doi.org/10.1002/cncr.30090DOI Listing
October 2016