SUPPLEMENTARY METHODS
SURVEY
Patient Selection for the Survey
Patients or surrogates were invited to participate in the survey after they were approached for consent in the parent study. Participants in the survey were the same participants who did or did not consent for the parent study (i.e., if a surrogate was approached for the parent study, the same surrogate was approached for the survey).
This was done regardless of whether consent was sought at the time of ICU admission or was deferred, and also regardless of whether the individual provided or declined consent for the parent study. Subjects were not selected for the survey based on any clinical criteria, the goal was 100% involvement in the survey. None of the investigators had a treating relationship with any of the study participants. Participation in the survey was approved by the Columbia IRB with a waiver of documentation of informed
consent.
Survey Design
The survey was designed to address the following key domains: (1)
patient/surrogate motivations for participating or declining to participate in ICU-based research, (2) patient/surrogate acceptance of a deferred consent process for a minimal risk study in ICU, and (3) patient/surrogate opinions about optimal consent processes for future minimal risk research. The survey was drafted with a goal of making each survey item as brief as possible to minimize the burden on survey respondents. We did
not include measures to assess internal validity by including positive and negative questions to address each domain. We anticipated that most ICU patients would complete the survey themselves and felt that 5 minutes of patients’ attention was the maximum that we would realistically be able to command.
Survey Pre-Testing
During a pre-study phase, face-validity of survey items was assessed by
reviewing items with five hospitalized patients or surrogates and asking them to explain back how they interpreted the meaning of each question. Minor changes to item
phrasing were then made in response.
Survey Implementation
The final survey consisted of brief demographic information followed by 8 multiple choice and open-ended questions evaluating the patient’s or surrogate’s opinions about the consent process. The complete survey instrument is reproduced below. After consent was sought for the parent study, the patient or surrogate was asked whether s/he was willing to answer a few questions to help us better understand how patients and their families felt about research in the ICU setting. The instrument was administered verbally, at the bedside by one of the investigators (MAT or DEF) over 5 minutes. The question “Did we make the right choice in waiting until now to ask your consent?” was only asked of those who were actually recruited using a deferred consent approach.
STATISTICAL METHODS
Open-Ended Questions
For open-ended questions, a coding scheme was developed based on content analysis and a priori hypotheses. Interviews were transcribed verbatim and copied immediately afterwards into a database. At the conclusion of the study, the database was reviewed and the verbatim answers to open-ended questions were each classified according to the coding scheme by two of the investigators (MAT and MCM). The classified answers were then compared side-by-side and discrepancies were reconciled by agreement of all three investigators. The coding scheme for each of the open-ended question was as follows:
What made you choose to be (or not to be) part of this research study?
Responses were coded into the following categories: (1) Participants: altruism/belief in research, procedures not a big deal, hope for direct benefit, other; (2) Non-participants:
discomfort/fatigue, rectal swab, stress, opposed to research in general, paperwork, concern for loss of privacy, no particular reason, other.
What happens to patients who are part of this research study? Responses were coded as correct if the respondent correctly stated the general aim of the parent study (e.g., “to understand gut bacteria in the ICU”) and the study procedures (oral and rectal swabs); partially correct for one but not both of these items; and incorrect for wrong answers or “I don’t know.” The common response that “nothing happens” was separately classified.
Did we make the right choice in waiting until now to ask your consent?
Responses were considered positive if respondents answered “Yes” or similarly, including answers that were “Yes, but…” Responses were considered negative if respondents answered “No” or similarly, including answers that were “No, but…”
Responses were considered neutral for anything in between, including tangential responses e.g., “The last time I was in the ICU…”
SURVEY INSTRUMENT
Open-ended QUESTIONS (verbal survey… document responses verbatim) Thank you for taking the time to think about this research study.
We are trying to learn how patients and their families feel about medical research in the intensive care unit. Would you be willing to take 5 more minutes to share some of your opinions? We will not write down your name or your family member’s name, or any information that can identify you.
1. What made you decide to do or not to do this research study?
2. What happens to patients who are part of this research study?
3. Do you have any questions about the research study?
4. When you or your family member was admitted to the ICU, we took a blood sample and a swab from the mouth and rectum. We waited until now to ask permission to use these samples as part of medical research, because the day of ICU admission can be very stressful. Did we make the right choice in waiting?
___ Yes ___ No
___ Other (Specify) What makes you think that?
Please mark one choice for each of the following questions:
1. Doctors should do research in the intensive care unit to try to learn how to better help patients in the future.
____ Strongly Agree ____ Somewhat Agree ____ Somewhat Disagree ____ Strongly Disagree
2. It is stressful to be asked about medical research in the ICU.
____ Strongly Agree ____ Somewhat Agree ____ Somewhat Disagree ____ Strongly Disagree
3. In the future, we may want to do a similar research study, one that involves taking one extra blood sample when patients are admitted to the intensive care unit.
If we try to do a research study like this in the ICU, what do you think we should do?
A. Take the blood sample when we need it, then ask the patient or family member for permission after things have settled down.
B. Ask the patient or family member for permission when they are admitted to the ICU, and do not take the blood sample unless permission is given.
C. It is not necessary to ask permission from the patient or the family member as there is no risk of harming the patient.
D. Other:
4. Are there any other thoughts that you’d care to share with us about doing research in the ICU? (open-ended) (Record responses verbatim)
