General Questions
1. What is the role and accessibility of each account?
We set up the following four “user types” which have different privileges and roles.
• Super_admin: all privileges, on all users of all centers of all regions
• Region_admin: all privileges, on all users of all centers of HIS/HER region (country)
• Center_admin: all privileges, on all users of HIS/HER center
• Regular_user: no privilege but can modify HIS/HER information in the management panel
2. How can I login to the database application?
Please access our study webpage “longventkids.ca,” read the content, and when you are ready to enter data, click on login, which will lead you to the app. If you do not have an account, please contact Atsushi Kawaguchi (Principal Investigator): atsushi@ualberta.ca Or (Research Coordinator: Christine Lord and Saly Elsalti): LongVentKids.@gmai.com.
3. There is more than one Pediatric ICU in my institution. Should you count them as one unit or collect the data as from a different unit?
If you can clearly separate the units (e.g., pediatric cardiac ICU, neuro PICU, Burn PICU) in terms of dedicated available beds, please count them as different units. If, for instance, PICU and so-called Pediatric Cardiac ICU share some or all the ICU beds, even if care teams (e.g., pediatric cardiac intensivist and neuro intensivist) differ, please consider those units as a single unit.
4. We have a so-called “Step down Unit,” which is a separate unit from PICU. Do we need to count this as a PICU?
No. If you think the step-down unit is not functioning as ICU level of care unit, please DO NOT include the unit or beds in this study. This is the case even if PICU physicians look after the cases/beds. If the step-down unit/beds cannot be clearly separated from other ICU beds and are under the care of the same team (i.e., same ICU physicians and nurses), please include the beds as PICU beds. For instance, three beds are considered as step-down unit/beds, but “real” PICU patients occasionally utilize those beds and are looked after by intensivists.
5. Some patients are under PICU physician team care but not physically in PICU.
Given the study aim to know the health care burden in PICU, we will not include those patients in this study.
Site Information
1. Our hospital is a general non-pediatric dedicated hospital. Which number should we put in for “Number of paediatric beds in hospital”?
In case there are a specific fixed number of beds for pediatric patients, please indicate the number. However, if it is not the case, please put in an estimated number and add a relevant free comment on to the database.
2. Our ICU is not PICU dedicated ICU. What number should we answer for “Number of paediatric beds in ICU”?
If there are a fixed specific number of beds for pediatric patients in your “Mixed” ICU, please indicate it. If your ICU does not have pediatric-specific beds then it is so-called “general mixed ICU” with adult patients or neonates, please report it in the answer for “type of ICU” and provide the most reliable estimated number, as a number of “paediatric beds in the ICU.”
3. What is “full-time staff”?
We do not make a definition of “full time” in this study, considering various contexts and understandings among countries. However, we would expect full-time as working in your “participating” unit approximately 40hours or more per week. If you or your colleagues work several different units and do not provide equivalent care as 40hours, please do not count them as full-time staff.
4. What is the definition of a physician in PCCM training?
We consider PCCM training as specific clinical training in pediatric critical care. If your resident or fellow is not in the program and does a short period of rotation training, please do not include them. In case there is no specific PCCM training program under a particular national or local PCCM society, but the trainees are on the training of PCCM for a particular period of years with a specific aim, please count them as a trainee of PCCM.
5. We have a rotating clinical fellow in our PICU. Can we say our program has a fellowship program?
Please refer the answer of question4.
6. Non-ICU dedicated physicians are responsible for some patients in our unit. Do we consider our unit as “closed model ICU”?
Yes. As long as the patients are under the ICU level of care, please include them.
7. Our so-called “step down unit” is under the care of the PICU team, including intensivists. Should we consider the unit as “Step down unit” still?
No. If you think the unit is not providing ICU levels of care, such as high-intensity nursing care or monitoring, please do not include them in this study. We do not specifically define “Stepdown unit,” such as based on the ratio of RN and patients.
8. Our unit accepts medical and surgical patients with neurological issues, including post neurosurgery patients (i.e., neuro PICU). Can we consider our unit as “Medical and surgical”?
Yes. We want to know the difference in incidence between dedicated surgical units and mixed units.
9. What is a primary physician during PICU care?
An individually responsible physician who overviews care of a patient throughout the PICU stay. This is different from the physician who takescare of the patients during a shift..
Screening
1. We have a certain number of patients who are under non-intensivist care in our PICU such as pulmonologist. Should we include those patients?
Yes.
2. Can patients on CPAP be considered patients on NIV?
No. In the e-CRF, you will be asked to put data separately.
3. What is the definition of HFNC?
In this study, we define nasal oxygen supply <1 L/kg/min or =<4LPM as non-HFNC practice and vice versa.
Patients Demographic Data
1. The nurse: patient ratio is not the same for day and night shift in our PICU.
Please indicate the ratio at the data collection day and time.
2. Does patient information such as body weight for the study date?
Yes.
3. Creatinine unit in PELOD2, how can we calculate if it is mg/dL?
1mg/dL=88.4micrommol/L
4. White blood cell and platelets unit conversion
1000 cells/mm3 = 1 cells*10^9L
90days Follow-up
1. Since we will not be tracking specific identifiers for each patient (such as MRN) that ties them to a particular study entry, how do we track the follow-up information?
The only way is to record MRNs (Medical record Number) and secure them in your file with password locks, for example, to refer them in your follow-up data collection. As noted in the protocol, we will exclude patients who have already been included in the previous screening, so the case already included in the last data collection day will not be counted as a new case. We will collect the number of MVed patients on each data collection date as well as eligible patients so that we can figure out “real” prevalence on each study day.
2. Will we be collecting patient information at a discrete point in time only (09:00 on each study date), or will we start data collection for each subject at that time and follow each subject longitudinally unitl the next study date?
This study is designed as “point prevalence sampling” with prospective observation. You can either access the database or input the data regularly (e.g., everyday) until 90days follow-up, OR access the database again after 90 days and collect the data accordingly. Whichever is more convenient for you is fine. .
Ethics and Data Storage
1. How and where are we storing data recorded?
Please refer the documents provided to the participating centres titled “Policies and Procedures of the “Laboratoire de Télématique Biomédical” of the Quebec Respiratory Health Network” for details of the procedure.
2. Is there any authorship rule?
Yes, there is a MOC rule and its authorized document. Please read carefully and understand the content. Please consult PI (Atsushi Kawaguchi: atsushi@ualberta.ca) or country/society representative if you have any questions. We will consider as if you understand and accept the rule before the study initiation.
3. If we have a post-hoc study idea, how and to whom should we contact?
Please contact (Atsushi Kawaguchi: atsushi@ualberta.ca). We will apply the same rule on the posthoc analyses and publications.
More Questions?
Contact us if you have any questions or comments
Principal Investigator: Atsushi Kawaguchi: atsushi@ualberta.ca
Research Coordinator: Christine Lord, Saly Elsalti: LongVentKids@gmail.com