Thematic Analysis of Cardiac Care Patient Explanations for Declining Contribution to a Genomic Research-based Biobank

Pamela Holtzclaw Williams JD, PhD, RN Jennifer Sanner, PhD, RN Lynne Nemeth. PhD, RN Lorraine Frazier, PhD, RN, FAAN

University of Texas Houston: University of Texas Houston: 3 UL 1 RR S1 CTSA Medical University of South Carolina; Medical University of South Carolina; UL1 RR029882

 Healthcare delivery systems are becoming genomic research sample collection sites

2 The Stewardship Model: Current Viability for Genetic Biobank Practice Development. Williams Pamela; Schepp, Karen; McGrath, Barbara; Mitchell, Pamela Advances in Nursing Science. Critique and Replication. 33(1):E41-E49, January/March DOI: /ANS.0b013e3181cd8367

1. Identify themes emerging from 568 cardiac critical care patients’ explanations for declining to contribute to a research biobanking initiative to collect blood samples and medical history for future cardiogenetic research. 2. Determine how these themes inform the stewardship conceptual framework for developing future evidence-based clinical ethics practices in genomic and genetic research biobanking.

 Many do not engage in traditional informed consent processes with sample contributors.  “Opt in” or “Opt out.”  This study employed opt in process.

 Combined inductive & deductive approaches.  Relevant to health services research seeking to develop themes and theory in clinical phenomena.

 Research nurses approached 4397 cardiac critical care patients for informed consent to participate in a biobank.  A standardized script directed their approach of patients at their bedside.  Within ERs, telemetry, cardiac catheterization and coronary observation units, coronary icus.  569 declined to participate and gave explanations of their reason.

 Handwritten recording of the explanations were transcribed into Excel spreadsheet.  Downloaded into NVivo 9.0  Inductive Approach: What are the themes in the patient responses that may explain their reasons for declining participation in these biobank approaches?

 Do themes emerging from the refusals’ content inform the theoretical constructs of the expanded Stewardship model?  Constructs from Stewardship model framed coding categories or “nodes” included: conceptualizations of the contribution, trust issues, risk issues, & human dignity concerns.

 Patients’ age range: 24 to 95 yrs.  Self-reported ethnicities & respective % declining:  White 60%  Black 27%  Hispanic 6%,  Asian 3%  1% American Indian  Others 3% reported > 1% of any single category  39% women, 61% men

 Family members involved in deciding and articulating decision.  “Approach Fatigue”- approached for other research as well.

 Theme of Intrusiveness  Physical  Confidentiality  Vulnerability/Frailty from illness/hospitalization  Values  Theme of Autonomy

 "I don't understand why I should do it. I'm not even understanding what the doctor is doing."  “I am just too stressed.”  "I am overwhelmed by all that is happening to me"  ”I’ve got too many things on my mind right now.”

 Concerns about Confidentiality.  Looking for Respect for Human Dignity.  Divergent characterizations of the proposal to contribute to biobank:  Research subject enrollment  Gift or donation  Expected mutual benefits

 "If there are no benefits or results for me, I am too tired to answer questions"  This slide contains examples of content that affirmed the Stewardship framework’s proposition that patient’s regard biobank contributions in ways other than research relationships.

 Intrusion & autonomy 2 primary themes that suggest need for future research.  Patients may perceive biobanking approaches as relationships other than research context.  Respect for human dignity in biobanking approaches is a paramount patient centered outcome in approaches with vulnerable, hospitalized persons.

 Limit Needle Sticks  Diminish Intrusiveness  Support Patient Autonomy  Maintain Trust

 Questions??