Research participants’ opinions of delayed consent for a randomized controlled trial of glucose control in intensive care.
Potter, J, McKinley, S, and Delaney, A. of the Royal North Shore Hospital, for the NICE-SUGAR Study Investigators, the Australian and New Zealand Intensive Care Society Clinical Trials Group, the Canadian Critical Care Trials Group and The George Institute for International Health NICE Study investigators
Journal: Intensive Care Medicine
Julie E Potter (Corresponding Author)
Research Coordinator
NSW Organ and Tissue Donation Service
South Eastern Sydney Local Health District
PO Box 486
Kogarah
NSW 1485, Australia
Email:
Telephone: +61 2 8566 1706
Fax: + 61 2 8566 1755
Sharon McKinley
Professor of Critical Care Nursing
UTS and Northern Sydney Local Health District
Royal North Shore Hospital
Pacific Highway
St Leonards
NSW 2065, Australia
Anthony Delaney
Intensive Care Specialist
Senior Lecturer, Northern Clinical School, Sydney Medical School
Intensive Care Unit
Royal North Shore Hospital
Pacific Highway
St Leonards
NSW 2065, Australia
Material for Online Resource
Methods
Cognitive Assessment
In order to assess the cognitive capacity of former ICU patients, the second question from the orientation section of the Mini-Mental State Exam (MMSE) [1], was used as a screening tool. This question was administered in the form of a request for people to confirm their best postal address, and provided an opportunity to talk further to evaluate the appropriateness of the person’s conversation [2]. When the responses were dubious, key informants such as spouses and adult children were contacted for confirmation of the person’s cognitive dysfunction, because they are considered to be highly reliable observers of a person’s cognitive functioning [3]. Information about the former ICU patient’s cognitive status was also sought from general practitioners.
Screening of former ICU patients, who had fulfilled the diagnostic criteria for a traumatic brain injury (TBI) when enrolled in the NICE-SUGAR study, was undertaken in consultation with an independent assessor. Approximately two years following enrolment in the NICE-SUGAR study the assessor had scored participant’s functional neurological outcomes during a structured interview conducted using the Extended Glasgow Outcome Scale (GOSE) [4]. The GOSE is an eight-point hierarchical scale containing lower and upper ranges for three major outcome categories which are: severe disability (3-4), moderate disability (5-6) and good recovery (7-8). For this study, the allocated GOSE score, in combination with the independent assessors’ judgement of the cognitive capacity of the individual, was used for evaluation of those who were categorised with a moderate disability. Individuals who were categorised with a good recovery were deemed to have cognitive capacity.
Questionnaire Development
Items included in the questionnaire were identified in the literature from searches of MEDLINE and PubMed using key words of clinical research, informed consent, critical care or intensive care, third party consent, substitute decision maker, research subjects, clinical trial and ethics. Literature was limited to the last 10 years, adults, human and the English language. The reference lists were reviewed to source additional literature.
In order to judge whether the questionnaire appeared appropriate for its intended purpose, it was assessed by a panel of 17 volunteers comprised of intensive care staff specialists, social workers, senior nurses, a chaplain, research coordinators, a nurse researcher, a ward clerk, a secretary and laypersons. These people reviewed the face validity and content validity of the questionnaire. Members of the panel reviewed the questionnaire twice before its distribution to study participants to assist in item generation, to ensure that questions had sufficient responses to choose from and to identify any that were poorly worded, difficult to answer or understand and required revision.
The panel were given the questionnaire and feedback sheet with three questions to answer:
Are the questions written clearly?
Do the questions make sense?
Are there any other questions or issues you think we should ask about [5]?
The first round of pilot testing took place following approval of the questionnaire and cover letter by the Northern Sydney Central Coast Health (NSCCH) Hawkesbury Human Research Ethics Committee (HREC) in January 2009. On this occasion there were 17 panel members from the Royal North Shore Hospital made up of six intensivists, two research coordinators, one senior nurse, one nurse researcher, one chaplain, two social workers, three administrative personnel, and one layperson. Responses were received from 11 members. Their suggested revisions were incorporated into the questionnaire by replacing one item, the addition of four Semantic Differential Rating Scales, and rewording of other items and the covering letter.
The revised questionnaire was sent for the second round of testing to seven panel members in April 2009. Responses were received from six members. Following suggestions, an additional covering letter and telephone transcript was developed for participants who were withdrawn from the NICE-SUGAR study treatment, with consent provided for use of study-related data, by their substitute decision maker.
The feedback from the panel assisted in confirming the wording, layout, clarity and meaning of the items and was conducted with the aim of ensuring the questions were interpreted the same way by all respondents. A copy of the final participant questionnaire is enclosed (Appendix A). The only that may have further strengthened this process would have been to pre-test the questionnaire with a group of former ICU patients.
References
1. Folstein MF, Folstein SE, McHugh PR (1975) "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 12 (3):189-198
2. Fan E, Shahid S, Kondreddi VP, Bienvenu OJ, Mendez-Tellez PA, Pronovost PJ, Needham DM (2008) Informed consent in the critically ill: a two-step approach incorporating delirium screening. Crit Care Med 36 (1):94-99
3. Gordon SM, Jackson JC, Ely EW, Burger C, Hopkins RO (2004) Clinical identification of cognitive impairment in ICU survivors: insights for intensivists. Intensive Care Med 30 (11):1997-2008
4. Wilson JT, Pettigrew LE, Teasdale GM (1998) Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma 15 (8):573-585
5. Heyland DK, Tranmer JE, Kingston General Hospital I. C. U. Research Working Group (2001) Measuring family satisfaction with care in the intensive care unit: the development of a questionnaire and preliminary results. J Crit Care 16 (4):142-149
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Study No:
Appendix A: Questionnaire
The following questions will help us to understand your opinion of the type of consent used for the blood sugar study (NICE). Your responses will be coded, so you will not be able to be identified personally.
When you were admitted to intensive care, your treating doctor enrolled you in the blood sugar (NICE) study. You were enrolled because your blood sugar levels were increased above normal or were thought likely to be. At that time you were unable to make a decision yourself.
1) How do you feel about being enrolled in the blood sugar (NICE) study in that circumstance?
Please indicate how you feel about this using the following pairs of descriptions below.
For each description place an ‘X’ on the line that comes closest to your first impression. There are no right or wrong answers.
Fair Unfair / Don’t know0 / 1 / 2 / 3 / 4 / 5 / 6 / 7 / 8 / 9
Content Discontented / Don’t know
0 / 1 / 2 / 3 / 4 / 5 / 6 / 7 / 8 / 9
Pleased Displeased / Don’t know
0 / 1 / 2 / 3 / 4 / 5 / 6 / 7 / 8 / 9
Angry Delighted / Don’t know
0 / 1 / 2 / 3 / 4 / 5 / 6 / 7 / 8 / 9
2) What were your thoughts when you found out that you had been enrolled in the blood sugar (NICE) study?
______Please continue to the next page.
Delayed Consent Survey Questionnaire Version 2 date 07 Apr 09 Page 1 of 4
Please return to Julie Potter in the pre-paid envelope provided
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Study No:
Your participation in the blood sugar (NICE) study was discussed with you and/or your relative/friend as soon as possible after enrolment.
3) This question is about the person or organisation that you would have most preferred to make the decision on your behalf to participate in the blood sugar (NICE) study, given that you were unable to make the decision yourself.
Please rank your preferences 1 to 8, with 1 being the person/organisation you would have most preferred and 8 being the one you would have least preferred. Please use each number only once.
The person who consented on my behalf for the NICE studyAnother relative or friend
A Government Regulatory Authority/Guardianship Tribunal
An Ethics Committee
The intensive care doctor looking after me
An independent doctor not looking after me
My General Practitioner (GP)
Someone else (please specify)______
4) Please indicate with a tick (b) the response that best describes the extent you agree with the following statements below:
Statements / Strongly Agree / Agree / Neither Agree nor Disagree / Disagree / Strongly DisagreeThe research/medical staff asked the right person to consent on my behalf. / ( ) / ( ) / ( ) / ( ) / ( )
My relative/friend made the same decision that I would have made, had I been able to decide. / ( ) / ( ) / ( ) / ( ) / ( )
I am content with the decision made by my relative/friend on my behalf. / ( ) / ( ) / ( ) / ( ) / ( )
Participation in the blood sugar (NICE) study will help intensive care patients in the future. / ( ) / ( ) / ( ) / ( ) / ( )
Please continue to the next page.
Delayed Consent Survey Questionnaire Version 2 date 07 Apr 09 Page 2 of 4
Please return to Julie Potter in the pre-paid envelope provided
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Study No:
5) If we could have asked you, would you have consented to participate in the blood sugar (NICE) study before we enrolled you?
q Yes
q No
6) Is there anything else regarding your participation in the blood sugar (NICE) study, you wanted to raise?
______
7) In general, would you say your health is: (Circle One)
Excellent1 / Very good
2 / Good
3 / Fair
4 / Poor
5
Please continue to the next page.
Delayed Consent Survey Questionnaire Version 2 date 07 Apr 09 Page 3 of 4
Please return to Julie Potter in the pre-paid envelope provided
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The following questions are about a little background information from everyone. Your responses will be coded, so you will not be able to be identified personally.
If you provided consent yourself, please start at question (10) and skip questions (8) and (9).
8) How long have you known the relative/friend who provided
consent on your behalf for the NICE study, in years?
9) Have you talked with the relative/friend (above), about participation
in research before your participation in the NICE study?
q Yes
q No
10) Do you speak any languages other than English at home?
q No, English only
q Yes, Italian
q Yes, Greek
q Yes, Cantonese
q Yes, Arabic
q Yes, Vietnamese
q Yes, Mandarin
q Yes, other (please specify) ______
11) What is the highest educational level you attained?
q Some high school
q Completed high school
q Some college/university
q Completed college/university
q Some technical school (e.g TAFE)
q Completed technical qualification
q Other education
12) What was your main activity before the illness that led to your
intensive care admission?
q Paid employment (full-time)
q Paid employment (part-time/casual work)
q Unpaid employment
q Domestic duties looking after home or family
q Permanent long-term sickness or disability
q Retired
q Student
q Other (please specify) ______
What is the date today?
Thank you for your time in completing this survey.
Delayed Consent Survey Questionnaire Version 2 date 07 Apr 09 Page 4 of 4
Please return to Julie Potter in the pre-paid envelope provided
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Appendix B: Verbatim responses and grouping
Appendix B: Verbatim responses and grouping
Verbatim responses of people to the question: “What were your thoughts when you found out that you had been enrolled in the blood sugar (NICE) study?”, and the thematic categorization into groups.
There were 202 people who commented. Responses are de-identified.
Group: Not worried, okay/fine, not a problem (N=47)
· Wasn’t worried
· No worries
· Not worried
· No worries. I have no problem with this and am happy to take part in this. Very pleased with RNSH and staff with my time there. They helped me a great deal! Thank you
· Did not worry me. As long as some good can come out of it for someone
· I was not particularly bothered
· Did not bother me in any way
· Didn’t bother me, because it will help future patients in intensive care
· It does not worry him. His GP checks him every 3 months for diabetes. I’m his wife. I have filled this in
· It did not worry me. I know from other studies I’ve participated in that ultimately my health & recovery is of prime importance to the staff, & if I am able to safely be involved in a study I’m happy to co-operate
· At the time I didn’t care and know it still does not worry me. The more tests the more you find out about yourself
· Wasn’t concerned. Choices were made in my best interests
· If it helps others why worry
· It didn’t worry me as RNS is a teaching hospital so any research can only benefit others
· Didn’t mind at all
· I didn’t mind. As long as it is non-intrusive I am happy to help
· Didn’t particularly phase me one way or another
· It did not concern me
· Not concerned, being unable to decide for myself
· I am OK with it
· OK
· OK
· OK
· Fine
· Fine
· Fine with it
· Good. Yeah OK. What were the results?