Patients’ Experiences inEmergency ResearchNeal Dickert, MD, PhD

Emory Program in Cardiovascular Outcomes Research and Epidemiology (EPICORE)

Department of Medicine, Division of Cardiology

Study Partners• PI- Rebecca Pentz• Sponsor- NINDS• Site Co-Investigators

• Michelle Biros• Jill Baren• Prasha Govindarajan• Art Pancioli

• Emory NETT team• NETT/RAMPART Leadership

EFIC Research- Ethical Challenges

• Well-known and numerous• Interpreting “unsatisfactory and unproven.”

• What is the goal of community consultation and how can that be achieved?

• Many of the toughest challenges are only magnified by the absence of consent

• EFIC research exposes an over-reliance on consent in general

The PolyHeme Experience

“Traumas Create Unwitting Test Subjects”USA Today 2006

“makes the inhabitants of 32 communities in 18 states, and anyone living or traveling near these communities, potential ‘guinea pigs’ without their consent and, absent consent, without full awareness of the risks and benefits.” Senator Charles Grassley, 2006

Patients’ Perceptions- Need for Data

• Good reasons to care about the views of enrolled patients.• Conceptual- problematic if patients feel exploited/violated.

• Practical- may offer ways to improve the experience

• Existing data sources are inadequate• Community consultation

• General Public

• Patients with similar conditions

EFIC Research- Public Views• Surveys of general public

• Often patients in ED waiting rooms

• Less than half supportive of EFIC research• Greater willingness (70%) to be included personally,

particularly if risks are minimal McClure et al, Acad Emer Med, 2003

• “Protocolization” of treatment may have negative effect. Abboud et al, J Med Ethics, 2006

• Reports from community consultation• Generally positive• Greater willingness to “approve” the study in the

community (82%) vs acceptance of being enrolled (64%) Longfield et al. Crit Care Med. 2008

EFIC Research- Public Views• Methodologic challenges

• Responses highly sensitive to wording of questions• Unclear whether participants understand

• Complicated, unfamiliar topic- no pre-formed opinions• Surveys don’t allow clarification

• Nature of objections unclear• Not the views of people actually included

• Attempts to target people at risk, to use non-closed-ended interview techniques.

EFIC Research- SCD Patients• 19 survivors of Sudden Cardiac Death

• In-depth interviews

• Greater acceptance than previous surveys.• Nobody said EFIC is unacceptable.

• Emphasis on risk/benefit• Comparisons of existing treatment widely accepted

• Greatest concern about new interventions

• Studies posing some risk w/o prospect of benefit.Dickert and Kass, Soc Sci Med, 2009

Resuscitation Research-SCD Patients

Case Description A R U N

1) New intervention for treatment of SCD 8 7 1 16

2) RCT- New Intervention v. std for SCD 7 4 2 13

3) RCT- 2 existing treatments for SCD 7 1 0 12*

4) RCT- Blood substitute v. saline for shock

13 1 1 19*

5) Public Access Defibrillator (PAD) Study 10 0 1 13**

6) No prospect of direct benefit- blood draw

18 0 0 18

7) No prospect of direct benefit- contrast posing 1/10,000 chance of death

12 3 2 17

*4 participants’ understanding insufficient. **2 participants’ understanding insufficient.

The PEER Study- Aims• Assess views of enrolled patients regarding

acceptability of EFIC and RAMPART enrollment• Provide baseline/benchmark data

• Identify patient and study factors that predict satisfaction/acceptance:• Conversations w research staff, understanding of

research, prior experience, demographics• Risk level, randomization, alternatives

• Assess whether Community Consultation elicits concerns of enrollees.• Will link to RAMPART CC research.

The PEER Study- Methods

• Structured, interactive interviews • In-person or telephone

• Series of open-ended questions followed by closed-ended questions• Facilitates quantitative and qualitative aims

• Allows participants space to develop views

• Allows insight into participants’ understanding of questions/issues

The PEER Study- Domains• Prior research experience & attitude toward research• Knowledge of the RAMPART study • Views on having been included in RAMPART• Views on acceptability of EFIC in research- in

RAMPART and in general• Views on randomization• Views on conversations with investigators/study staff• Views on community consultation• Impact of public disclosure• Trust in researchers and in clinical research• Demographics and medical background

The PEER Study

• Participating Sites• 5 sites- UCSF, UC, Emory, UM, and UPenn

• 1 trained interviewer per site

• Sample• English or Spanish speaking RAMPART

enrollees or surrogate/LAR

• 20 subjects per site (n=100)

The PEER Study- Status

• IRB-approved at all participating sites

• Interview guide pre-tested at Emory

• Interviewer training in progress

• All sites to begin formal enrollment shortly

• Key challenge- Successful re-contact

The PEER Study- PROTECT Phase

• Sponsor- Greenwall Foundation

• Similar in scope and design• Target= 100 participants (patients and decision-makers)

• Includes anyone initially enrolled using EFIC

• Target interview time = 3 months post-enrollment

• Key differences• Interviews conducted by central firm (APCO Insight)

• All NETT sites invited to participate by referring participants.

PEER Studies- Critical Comparisons

• RAMPART• Comparison of existing interventions• Relatively low mortality/morbidity• Many patients with pre-morbid illness

• PROTECT III• Placebo-controlled trial of a new

intervention• High mortality/morbidty• Most patients with no pre-morbid illness

Summary• Unique opportunity to gather important data

on patients’ experiences in EFIC research

• Ability to connect with existing work on CC

• Addition of PROTECT Phase offers important cross-study comparative data

• Illustrates commitment of NETT • Improving understanding of ethical challenges• Implementing data-driven approaches