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??