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Participation of Ontario ICUs in Critical Care Pandemic Research

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This survey is funded by grants from CIHR, the Physicians’ Services Incorporated Foundation and the Public Health Agency of Canada

and is being conducted under the auspices of the Canadian Critical Care Trials Group and the International Forum for Acute Care Trialists (InFACT).

Participation of Ontario ICUs in Critical Care Pandemic Research

We are interested in your views regardless of whether or not you were an ICU

administrator/medical director during the H1N1 waves (April 2009 – January 2010).

If this survey is NOT relevant to you, please let us know by checking the box below and either returning the questionnaire in the self-addressed stamped envelope provided or faxing this page to us at 416-864-5141. Thank you!

I have never been nor am I currently an ICU administrator/medical director.

We would be grateful if you could direct us to the appropriate person at your site by providing their name on the line below:

_________________________________________________________

Glossary

Observational Study: A study in which data are collected but no experimental maneuvers are performed. They are studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may have received diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.

Qualitative Study: A study in which the approach to knowledge is interpretative. The data are viewed subjectively to gain insights into experiences and actions. Data analysis focuses on interpretation of words rather than numbers.

Randomized Controlled Trial: An experimental study in which patients are allocated to one study arm or another at random (by chance) to compare the relative effectiveness of each intervention.

Basic Science: A study designed to examine the basic mechanism of action (e.g., physiology, biomechanics) of an intervention.

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Part A. Your ICU’s Research Experiences During H1N1

1. Did YOUR intensive care unit (ICU) provide ongoing care (for at least 72 hours) to critically ill adults or children with H1N1 during the recent H1N1 waves (first or second wave; from April 2009 to January 2010) in Ontario? (Please check ONE response ONLY).

Yes, [please specify population(s) by checking ALL that apply] adults children No, we provided initial care and then transported patients out of our ICU:

[please specify population(s) by checking ALL that apply] adults children No, we did not care for patients with H1N1

Part B. Your Beliefs Regarding Pandemic Research

2. How helpful do YOU feel that pandemic ICU research is to OUR collective ability to provide health care to critically ill Ontarians in future pandemics?

(Please check ONE response ONLY to indicate YOUR belief about how helpful pandemic research is).

Very Neither unhelpful Very

Unhelpful nor helpful Helpful

1 2 3 4 5 6 7

3. How important do YOU believe it is for YOUR ICU to be able to participate in ICU research specifically related to pandemics?

(Please check ONE response ONLY to indicate YOUR belief about the level of importance).

Very Neither unimportant Very

Unimportant nor important Important

1 2 3 4 5 6 7

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4. Regarding YOUR beliefs about YOUR ICU’s ability to participate or not participate in recent H1N1 research, indicate YOUR level of agreement with each statement in the

left-hand column. (Please check ONE response ONLY to indicate YOUR level of agreement).

Statement Strongly

Disagree

1 2 3

Neutral

4 5 6

Strongly Agree

7

Not Applicable

(staff or service not

available)

Regarding LOCAL RESEARCH RESOURCES:

a) Local REB and contract services processed applications and contracts rapidly for H1N1 research b) We had sufficient numbers of research coordinators (or local equivalents) to implement H1N1 ICU research c) We had pharmacy support to implement H1N1 studies involving medications

d) We were concerned about our ability to conduct H1N1 research while providing patient care e) We were concerned about our ability to recruit, enroll and collect data on patients for H1N1 research f) We were concerned that the H1N1outbreak would be short lived (i.e., be over before H1N1 studies were up and running)

Other local research resource issues? Please specify: _____________________________________________

____________________________________________________________________________________________

____________________________________________________________________________________________

Legend: REB = research ethics board; ICU = intensive care unit; H1N1 = Novel Swine Origin Influenza A/H1N1

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5. Regarding YOUR ICU’s capacity to participate in future ICU pandemic research, please indicate YOUR level of agreement with each statement in the left-hand column.

(Please check ONE response ONLY to indicate YOUR level of agreement).

Statement Strongly

Disagree

1 2 3

Neutral

4 5 6

Strongly Agree

7 a) We would like to participate in

pandemic research

b) Local REB and contract services need to fast track pandemic research documents to permit timely research initiation c) Designated funding for research personnel (i.e., research

coordinators or local equivalents) is required to enable pandemic research

d) Adequate study ‘start up’

funding is required for REB and contract services

e) Adequate remuneration for patient screening is required f) Adequate ‘per patient

remuneration’ for enrollment and data collection is required g) Clearer guidance regarding co- enrollment (enrollment of one patient in more than one study) is required from regulatory bodies (REBs, HC, FDA)

h) Alternative consent models (other than SDM consent in adults and parental consent in pediatrics) are required

i) Pre-approved template protocols and consent forms for REBs and HC [specifying population and outcomes with commonly used adjuvant treatments (e.g., steroids)] are required for timely research initiation

Other, please specify:___________________________________________________________________________

____________________________________________________________________________________________

____________________________________________________________________________________________

____________________________________________________________________________________________

Legend: REB = research ethics board; SDM = substitute decision maker; HC = Health Canada; FDA = Food and Drug Administration.

Adjuvant = A drug or agent added to another drug or agent to enhance its medical effectiveness.

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Part C. Your ICU’s Participation in H1N1 Research

6. How important do YOU believe it is for YOUR ICU to be able to engage in clinical and research activity (i.e., to provide both clinical care and conduct research) during a pandemic?

(Please check ONE response ONLY to indicate YOUR belief about the level of importance).

Very Neither unimportant Very

Unimportant nor important Important

1 2 3 4 5 6 7

Part D. Demographics

*ALL Demographic Data should reflect individuals who have been or are currently ICU administrators/medical directors.

7. Please indicate which of the following best describes YOU (see note above):

(Please check ALL that apply).

I am a physician

I am a nurse or nurse manager (SKIP to Q9) I am an administrator (SKIP to Q9)

Other, please specify ______________________________ (SKIP to Q9) 8. If YOU are a physician, please indicate in which areas YOU work clinically?

(Please check ALL that apply).

Internal Medicine Respirology Surgery Anaesthesia

Pediatrics (General or specialty, other than pediatric critical care medicine) Pediatric Critical Care Medicine

Adult Critical Care Medicine Emergency Medicine

Other, please specify: _____________________________

9. How many years have YOU been working in intensive care as an administrator/medical director?

Years

10. In which type of hospital(s) do YOU work? (Please check ALL that apply).

University affiliated/Tertiary referral (with physicians-in-training) Community affiliated (with physicians-in-training)

Community affiliated (no physicians-in-training) 11. Which patients do YOU care for in YOUR ICU(s)?

(Please check ONE response ONLY).

Adult patients Pediatric patients

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12. How many ICU beds are there in the unit(s) which YOU manage in YOUR hospital(s)?

Total number of available ICU beds (capable of caring for patients requiring invasive ventilation)

Total number of ICUs Total number of hospitals

13. Which type(s) of ICU(s) do YOU manage? (Please check ALL that apply).

Medical Surgical MedSurg Multidisciplinary CVICU Trauma

Neuro Neurotrauma Burn Other, _____________

14. Which type of model best describes YOUR ICU(s)?

(Please check ONE response only).

Open model Closed model

Mixed models (open and closed) in one hospital

Mixed models (open and closed) in more than one hospital

Other, please specify______________________________________

15. In total, how many staff physicians work in any capacity in YOUR ICU(s) taking primary care of critically ill patients at present?

|__|__|

16. Were YOU an ICU administrator/medical director in Ontario during one or both of the recent H1N1 waves (first or second wave; from April 2009 to January 2010)?

Yes No

An Open ICU Model: Patients are admitted under the care of an internist, family physician, surgeon or other primary attending of record, with intensivists providing expertise through consultation. Intensivists may play a primary role in the management of some patients but only with the agreement of the attending of record.

A Closed ICU Model: After admission, patients are transferred to the care of an intensivist assigned to the ICU on a full-time basis. Generally, patients are accepted to the ICU only after approval/evaluation by the intensivist. For periods typically ranging from one week to one month at a time, the intensivist's main clinical duties consist of caring for patients in the ICU.

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17. Would YOU be willing to participate in clinical ICU research during the next pandemic with YOUR current research infrastructure and resources?

Yes

If Yes, please indicate which type: (Check ALL that apply) Observational Qualitative RCT Basic Science

No

18. Would YOU be willing to participate in clinical ICU research during the next pandemic if the required research infrastructure and resources were made available to YOUR ICU(s)?

Yes

If Yes, please indicate which type: (Check ALL that apply) Observational Qualitative RCT Basic Science

No

Please indicate the date of survey completion: |__|__| |__|__| |__|__|__|__|

d d m m y y y y

Thank you for completing this questionnaire!

Please return the questionnaire in the self-addressed

stamped envelope provided.

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