Thematic Analysis of Cardiac Care Patient Explanations for Declining Contribution to a Genomic...
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Transcript of Thematic Analysis of Cardiac Care Patient Explanations for Declining Contribution to a Genomic...
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
Collaboration of 2 CTSA Awards Sites
• University of Texas Houston:3 UL 1 RR024148-03S1 CTSA
• Medical University of South Carolina;
UL1 RR029882
Background & Significance
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 2010.DOI: 10.1097/ANS.0b013e3181cd8367
Study Aims
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.
Biobank Approaches
Many do not engage in traditional informed consent processes with sample contributors.
“Opt in” or “Opt out.”
This study employed opt in process.
Methods: Qualitative Thematic Analysis
Combined inductive & deductive approaches.
Relevant to health services research seeking to develop themes and theory in clinical phenomena.
Protocol
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.
Data Analysis Methods: Inductive Approach
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?
Data Analysis Methods: Deductive Approach
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.
Sample Characteristics
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
Context Characteristics
Family members involved in deciding and articulating decision.
“Approach Fatigue”- approached for other research as well.
Inductive Approach Results
Theme of Intrusiveness
Physical
Confidentiality
Vulnerability/Frailty from illness/hospitalization
Values
Theme of Autonomy
Examples
"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.”
Results from Deductive Approach
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
Examples
"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.
Conclusions
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.
Implications for Future Research
Limit Needle Sticks
Diminish Intrusiveness
Support Patient Autonomy
Maintain Trust
The End
Questions??