Material for Electronic Repository
Methods
Instrument Development
To identify important items to include in the questionnaire we searched MEDLINE and
EMBASE for literature related to research conduct, substitute decision makers, and informed
consent in the ICU. From these searches we identified the most relevant items related to SDMs
and decision making for critical care research. We also solicited 5 intensivists, 4 research
associates, 2 pharmacists and 6 nurses at Mount Sinai Hospital, Toronto, to determine
additional important survey items. We sampled to redundancy; that is, we terminated this phase
of instrument development when no new domains or items were identified. The initial search for
potentially relevant items yielded approximately 40 items, many more than could be included in
the final questionnaire. The number of items was reduced to 20-25 by circulating a
questionnaire to 10 members of the multidisciplinary ICU team, which asked participants to
comment on the relevance of each item to the survey objective, and appropriateness of the
response options. To ensure clarity, realism and validity of the survey instrument, 3 experts with
survey methodology expertise individually reviewed the questionnaire discussing and revising
until no further issues arose. Eight additional ICU physicians and nurses reviewed the survey for
clarity and ease of completion.
Questionnaire Administration
To identify the primary SDM for research decision-making, we followed the Ontario
Health Care Consent Act, which states “A substitute decision maker is someone authorized by
the Ontario Health Care Consent Act to make health care decisions on behalf of an individual
who has been deemed incapable of making his or her own decisions. A substitute decision
maker is the highest-ranking individual (or individuals) from a list of appropriate substitutes
outlined in the Ontario Health Care Consent Act” (http://www.elaws.gov.on.ca/html/statutes/english/elaws_statutes_96h02_e.htm). Once we identified the
primary SDM, he/she decided which family members would be involved in the consent process.
During the time that this questionnaire study was conducted, ongoing parent research
studies included nine interventional randomized trials on ventilator weaning, high frequency
oscillation, sedation management, thromboembolism prophylaxis, community-acquired
pneumonia, antiviral treatment, glutamine and anti-oxidant supplementation, tight glucose
control, continuous renal replacement therapy; and three observational studies on physiologic
markers in sepsis, patient recall of ICU stay, and long-term patient outcome following ICU stay.
SDMs were approached for at least one interventional trial and one observational study; we did
not record which research studies they were approached for.
Statistical analysis
Factors which we anticipated may be associated with the provision of consent included higher
level of education, a health professional in the family, later timing of approach following ICU
admission, a clinical update from the physician prior to the research approach, and lower
perceived severity of illness of the patient. Factors which we anticipated would be associated
with consent refusal were mistrust of medical research, earlier timing of approach for research,
inadequate time spent explaining the study, and higher perceived severity of illness of the
patient.
Results
There were no differences between groups in the following characteristics (Table 2): an
introduction to the research study from the physician prior to the approach for research, the
SDMs’ perception of the severity of illness of their family member, the timing of research
approach, SDMs’ recollection of the parent studies, the number of relatives involved in the
consent decision, or how the decision about research participation was finally made.
Appendix 1 – Questionnaires
PROXY CONSENT Study - Agreement Questionnaire
1. What is your relationship to the patient?
□ Spouse/ partner □ Child
□ Parent
2. Is English your first language?
□ Yes
3. What is your ethnic background?
□ African-American
□ Other: _______________
□ Asian
4. Gender:
□ Male
□ Female
□ Other: ______________
□ No
□ Caucasian
□ Hispanic
5. How old are you?______________________
6. What is your highest level of education?
□ High School
□ College Diploma
□ Undergraduate Degree
□ Graduate Degree
□ Other, please specify: __________________________
7. Are you a health care professional or do you have a family member with medical training?
□ No
□ Yes
8. Were you asked to consider giving consent for more than one study?
□ No
□ Yes If Yes, how many? □ 2
□3
□ More than 3
9. What was the main reason for your decision to consent for the research study/studies?
______________________________________________________________________________________________________
____________________________________________________________________________________
10. Did any of the following factors influence your decision to agree to the study (Please tick all that apply)
Research studies are important for medical progress
I wanted to contribute to medical science
The research study may positively affect the medical care that my relative receives
I did not want to disappoint the ICU team
I wanted to give something in return for the care my relative is receiving
I liked the way the research study was presented
The research study may help other people
I trust the medical team
My relative may receive the new treatment rather than the usual treatment
Any study treatment is better than usual treatment for this medical condition
The research study could benefit my relative
My relative has been enrolled in a research study before
My relative would have agreed to participate, if he/she were able to
No real reason
Other, please specify:
11. Do you recall the research study/studies that you were approached for?
□ No
□ Yes if Yes, please check which study/studies:
A study on: □ drugs
□ blood sugar
□ kidneys/ hemodialysis
□ breathing/ ventilation □ sedation
□ nutrition
□ blood gases
□ recovery from ICU
12. When did you hear about the research study?
□ Within 24 hours of my relative being admitted to the ICU
□ Between 24 - 48 hours after being admitted to the ICU
□ After more than 48 hours of ICU admission
13. Did a physician talk to you about your relative’s condition before you were approached for the research study?
□ No
□ Yes If Yes, did the physician mention the research study to you? □ No □ Yes
14. Who first told you about the research study?
□ Nurse
□ Physician
□ Research coordinator
□ Social worker
□ Respiratory therapist
□ Other, please specify: _____________________
15. In your opinion, how serious was your relative’s condition when you were asked to consider the research study?
□ Critical
□ Serious
□ Getting worse
□ Stabilized
□ Already recovering
□ Other, please specify: ______________________
16. How many members of your family took part in the consenting process?
□ Only me □ 2
□3
□ 4 or more
17. When you and your family considered having your relative participate in the research study, were there different opinions
about the study?
□ No one else was involved in the decision process
□ Yes, but we came to a consensus
□ Yes, and we could not come to a consensus, but I agreed to have my relative participate anyway
□ No, all of us agreed to have our relative participate
18. Would you agree to have your family member participate in a research study again in the future?
□ Yes
□ No
19. If you wish to add a comment, please do so:
______________________________________________________________________________________________________
______________________________________________________________________________________________________
PROXY CONSENT Study - Decline Questionnaire
1. What is your relationship to the patient?
□ Spouse/ partner □ Child
□ Parent
2. Is English your first language?
□ Yes
3. What is your ethnic background?
□ African-American
□ Other: _______________
□ Asian
4. Gender:
□ Male
□ Female
□ Other: ______________
□ No
□ Caucasian
□ Hispanic
5. How old are you?______________________
6. What is your highest level of education?
□ High School
□ College Diploma
□ Undergraduate Degree
□ Graduate Degree
□ Other, please specify: __________________________
7. Are you a health care professional or do you have a family member with medical training?
□ No
□ Yes
8. Were you asked to consider giving consent for more than one study?
□ No
□ Yes If Yes, how many? □ 2
□3
□ More than 3
9. Do you recall the research study/studies that you were approached for?
□ No
□ Yes if Yes, please check which study/studies:
A study on: □ drugs
□ blood sugar
□ kidneys/ hemodialysis
□ breathing/ ventilation □ sedation
□ nutrition
□ blood gases
□ recovery from ICU
10. Did you understand the goal of the study/studies?
□ Yes
□ No
11. Did you understand why your relative was a good candidate for this study?
□ Yes
□ No
12. What was the main reason for your decision to decline the research study/ies?
______________________________________________________________________________________________________
______________________________________________________________________________________________________
13. What were your reasons for declining the research study? (Please check all that apply)
Research has no place in the ICU
The research study may affect the medical care that is offered to my relative
There may be more risk than benefit in the research study
The research study was presented at the wrong time
I didn’t want to burden the nurses that are taking care of my relative
There was disagreement in my family regarding the study
I do not trust medicine or medical science in general
I do not trust the medical team
I have had bad experiences with research studies
I didn’t want my relative to receive placebo (inactive medication)
I didn’t want my relative to receive any experimental treatment
I did not like the way the research study was presented
I was too worried about my relative’s condition to even consider a research study
I didn’t feel comfortable making the decision for my relative
I do not want my relative to be a ‘guinea pig’
I do not think that my relative is the right person to receive research study treatment
My relative has been enrolled in a clinical trial before
I know my relative would not want to be involved in research
No real reason
Other, please specify:
14. Would your decision to decline the research study be the same if you were asked TODAY?
□ Yes □ No
If No,…why? (Please check all the answers that apply)
I had more time to think about the research study
I talked about the study to other people outside the hospital
I read about this online and now feel more comfortable with what is going on
I talked to other staff in ICU and I got more information about my relative’s status
I received more medical information about the study from the staff in ICU
My relative’s condition is more stable and I am not as worried
My relative’s condition is worse
15. When did you hear about the research study?
□ Within 24 hours of my relative being admitted to the ICU
□ Between 24 - 48 hours after being admitted to the ICU
□ After more than 48 hours of ICU admission
16. Did a physician talk to you about your relative’s medical condition before you were approached for the research study?
□ No
□ Yes If Yes, did the physician mention the research study to you? □ No
□ Yes
17. Who first told you about the research study?
□ Nurse
□ Physician
□ Research coordinator
□ Social worker
□ Respiratory therapist
□ Other, please specify: _____________________
18. In your opinion, how serious was your relative’s condition when you were asked to consider the research study?
□ Critical
□ Serious
□ Getting worse
□ Stabilized
□ Already recovering
□ Other, please specify: ______________________
19. How much time was spent on the consenting process?
□ Long enough to have all my questions answered
□ Too long, and I got more information than I needed
□ Not enough time
20. Was the medical language used understandable?
□ Yes
□ No
21. Did you have enough time to make your decision?
□ Yes
□ No
22. Did you know that the research study is closely monitored by an Independent hospital Ethics Committee?
□ Yes
□ No
23. How many members of your family took part in the consenting process?
□ Only me
□2
□3
□ 4 or more
24. When you and your family made the final decision, were there many differing opinions about refusal or agreement?
□ No one else was involved in the decision process
□ Yes, but we came to a consensus
□ Yes, and we could not come to a consensus, but I declined the study anyway
□ No, all of us agreed to have our relative not participate
25. Would you agree to have your family member participate in a research study in the future?
□ Yes
□ No
26. Do you think that research studies are important for medical progress?
□ Yes
□ No
27. If you wish to add a comment, please do so:
______________________________________________________________________________________________________
______________________________________________________________________________________________________
Appendix 2 – Verbatim responses of SDMs to the question: “What was the main reason for your
decision regarding the research study?”, and the categorization into groups.
AGREE GROUP
To help my loved one recover faster (N=17)
Possible quicker recovery
Provide best possible care for my husband
Possibility of speedier recovery
Help her with her sedation needs to come off mv sooner
Perceived benefit to our family member
Help my son or someone else down the road
To help my son recover
I want to get him off sedation and ventilator asap
Some benefit to the patient
Anything that would benefit my husband
To benefit my dad’s health
To help him get back to a normal life
Might be beneficial to wife and others
May benefit the pt
Study may help my dad or other people
Results of the study could be positive for my wife and/or other people in the same situation
To help my husband recover faster
To improve patient care in the future (N=14)
Help the community and give back
Studies like these may help future pts
To help hospital provide better care to patients
To help others
I want to help others, even if it does not help my sister
To assist others
The future benefits to patients
Help others recover more quickly
Help others in the future
It would help others
To help others in the future
Both drugs are good/one may be better. I hope you find out
Hope to help future patients
To help other people
Research is important to improve medical care (N=9)
In teaching hospitals research is important if doesn’t aggravate pt condition
Without research it is difficult to learn how best to treat pts both in the hospital and aftercare
Research is critical to improving pt medical delivery
I believe in trying things that help and be good or better for you
To improve healthcare
It helps medicine
I am a researcher and appreciate the importance of research
To help and improve our healthcare system
To find best practice for patient care
Miscellaneous
Doctor recommended it (N=1)
The study medication is better than the standard of care medication (N=1)
Because it was not invasive (N=1)
It did not interfere with my wife’s primary care (N=1)
DECLINE GROUP
Fear of harm or discomfort to the patient (N=8)
Do not want to take any risk
The study will put undo pain on my wife
I do not want to join b/c there is no proof it is beneficial, and may hurt him
Didn’t feel my father needed any unnecessary irritations
He had so much treatment and tubes I did not want him to have something further to cope with
She’s been poked for various tests daily for the past month and is very sore from it. I don’t think
this study would be appreciated by her.
If something bad happens did not want to use study as an excuse.
Common sence – I don’t want her to suffer more
SDM too worried/anxious to consider research at that time (N=6)
We considered entering her into the study but were given grim news
I didn’t have the time or patience (energy) to discuss this with my family b/c there were so many
other important decisions to make
Too much going on at the time
We were asked too soon about the study, we were more concerned about the pt’s recovery
It just seems like such a difficult time to make such a huge decision
Depending on criticality of the case it is not a good time – I would recommend studies avoid
very critical and complex cases like this one
SDM was satisfied with the standard care provided (N=2)
Wanted standard protocol
Because I know that whatever is being done is excellent so I decided to keep things as is
Miscellaneous
“Personal” (N=1)
Suggest collaboration with attending physician is available to discuss outcome for the particular
individual being enrolled (N=1)
I do not like the fact the study is run by a company who makes the product (N=1)