multiple breath nitrogen washout testing site training and ... › ratjen › wp-content › uploads...
Post on 04-Jul-2020
2 Views
Preview:
TRANSCRIPT
Multiple Breath Nitrogen Washout Testing
Site Training and Qualification Requirements
The Hospital for Sick Children
1
Version Date: April 27, 2016
MBW Central Training and Over-Reading Centre
The Hospital for Sick Children has worked together with MBW researchers from around the
world to develop a standard testing manual (MBWN2 Standard Operating Procedure) to facilitate
standardized testing of the Nitrogen Multiple Breath Washout (MBWN2) for multi-centre clinical
trials. The team has also developed an intensive hands-on training course based on this manual,
and an operator certification process. If you have any questions you can contact our team at:
mbw.centre@sickkids.ca
Site Qualification Process
Qualification of operators for MBWN2 testing for North American sites will occur as a two part
process. 1) MBW operators are required to attend a training session on the operation of the
MBWN2 system according to the working group standard operating procedure (SOP). 2) After
attending a training session operators are required to submit MBWN2 qualification tests to the
central over-reading centre for review. Once qualification tests are deemed successful the site
will be considered qualified for MBWN2 testing. Qualification is independent of a study but
specific to age group of intended study population.
MBWN2 Training
General Training Requirements – Who requires training?
The operators who attend the training session should be the same individuals who will carry out
MBW measurements on study participants. The training is designed to facilitate making real-
time decisions about test quality. Only certified operators will be qualified to perform MBW
measurements for clinical trials.
Preschool Training Requirements – Who requires training?
Operators wishing to be trained in preschool testing must attend preschool specific training
either stand alone or as part of a combined adult and preschool training session.
MBWN2 Qualification Tests
Upon completion of training, each operator should collect and submit a pre-determined number
of qualification test occasions. Adult and pediatric (6+ years) qualification tests should be
submitted and approved by the MBW centre before preschool qualification measurements are
collected.
Multiple Breath Nitrogen Washout Testing
Site Training and Qualification Requirements
The Hospital for Sick Children
2
Version Date: April 27, 2016
Number of Trials to Submit – Adult and Pediatric (6+ years)
Each site should submit a minimum of 10 qualification test occasions; these can be completed
by a single operator or two operators (submitting 5 each). Any additional operator should
submit 5 qualification test occasions. Adult and pediatric MBW testing requires only one
operator to perform the testing. MBW testing must be performed solely by the operator
wishing to be certified. Further details are listed in the Table below.
SUBMISSION AND QUALIFICATION REQUIREMENTS – for studies involving subjects aged 6+
years
Number of
Operators
per Site
Number of
Test
Occasions
required PER
OPERATOR
TOTAL Number
of Test
Occasions
required PER
SITE
Number of
Successful Test
Occasions required
for INDIVIDUAL
Qualification
TOTAL Number
Successful Test
Occasions required
for SITE Qualification
1 10 10 8/10 8/10
2 5 each 10 4/5 each 8/10
3 5 each 15 4/5 each 12/15
4 5 each 20 4/5 each 16/20
Number of Trials to Submit – Preschool
Preschool testing requires 2 operators; both operators wishing to become certified in preschool
testing must be present at the test.
Upon completion of preschool specific training, sites will be asked to submit a minimum of 5
qualification MBWN2 test occasions to Sick Kids hospital for over-reading.
SUBMISSION AND QUALIFICATION REQUIREMENTS – for studies involving subjects 3-6 years
of age
Number of
Operators* per
site.
TOTAL Number of
Test Occasions
required PER SITE
TOTAL Number Successful
Test Occasions required for
SITE Qualification
*Operators submitting
preschool studies
must be previously
qualified for testing
school-age/adult.
2 5 4/5
3 8 7/8
Multiple Breath Nitrogen Washout Testing
Site Training and Qualification Requirements
The Hospital for Sick Children
3
Version Date: April 27, 2016
Qualification Subject Population – Who to test? Adult and Pediatric (6+ years)
Sites should test five healthy volunteers (no history of chronic pulmonary disease) and five
subjects with a confirmed diagnosis of CF roughly split between operators. In general these
subjects should be representative of the age group of the study population (i.e. paediatric
centres testing paediatric study subjects should include at least 50% paediatric subjects in their
qualifier test occasions).
At minimum sites should include at least:
2 CF patients
1 subject must be in the range of the study population (e.g. at pediatric centres)
Qualification Subject Population – Who to test? Preschool (3-6 years)
Subjects tested for qualification should be representative of study population and sites should
aim to test as many subjects belonging to this group as possible.
At minimum sites must include at least:
2 children with CF
One child <4 years
Site Expectations for MBWN2 for Adult, Pediatric and Preschool Qualification Data
Collection
1. MBWN2 device operation and data collection in adult and school age children should be
performed according to the MBW working group SOP. At present preschool testing
should be performed according to study specific MBW SOP. Test occasions collected
previously, and not tested to current SOP guidelines will not be accepted.
2. Sites must ensure Spiroware version 3.1.6.17312/3 (May 2014) prior to exporting any
subject files for submission to over-reading center. (nb. Data collection is not affected
by software version date).
3. Each test occasion submitted should represent a discrete subject.
4. Sites should aim to collect 3 good quality trials per test occasion.
5. Poor quality trials should be excluded from summary results by the site.
Multiple Breath Nitrogen Washout Testing
Site Training and Qualification Requirements
The Hospital for Sick Children
4
Version Date: April 27, 2016
The Spiroware version can be found at the bottom of the Administration menu.
Spiroware File Naming
Only de-identified subject files will be accepted by the MBW
centre. Studies submitted as MBWN2 qualification tests should
use the following naming scheme:
Last Name: Site Number
o Site number will be assigned by the MBW
centre.
First Name: Qualification Subject Study Number
o Please assign each qualification subject a
discrete study number (ie. QS1 – QS10)
ID: Site Number.Qualification Study Number (e.g.
10.QS1)
Date of birth: please enter as accurately as IRB allows.
Height and weight: please enter accurate measurements from day of test . Obtain
measurements as you would for a study participant
If you do not have a Qualification Subject Study Number, please contact the MBW
centre(mbw.centre@sickkids.ca)
Multiple Breath Nitrogen Washout Testing
Site Training and Qualification Requirements
The Hospital for Sick Children
5
Version Date: April 27, 2016
Successful Test Occasion
A successful MBWN2 test occasion will consist of 3 acceptable trials.
Acceptable trials are defined as trials having:
1. No evidence of leak
2. No evidence of coughing, laughing or talking
3. No evidence of signal misalignment
4. No evidence of inadequate time between trials
5. Clear satisfaction of end of test criteria
6. Grossly normal tidal breathing pattern*
*Sites should aim to demonstrate ability to coach subjects into breathing in a relaxed tidal
breathing pattern during the pre-washout and washout phase of testing. Only trials with grossly
distorted breathing pattern will be deemed unacceptable for breathing pattern alone.
Sites may choose to use a worksheet to help guide the operator in collection of acceptable
quality trials. (A suggested worksheet will be available from the MBW Centre).
The MBW Centre will request by email that sites re-transmit MBW data if data submitted
requires correction.
Signal misalignment
System settings incorrect
File name incorrect
Data Export
*Any site who does not have this software version should contact Eco Physics for software
update.
Sites must confirm Spiroware software version (3.1.6.17312/3 (May 2014)) PRIOR
to exporting subject files. *
***Files must be saved as DRAFT prior to export***
Multiple Breath Nitrogen Washout Testing
Site Training and Qualification Requirements
The Hospital for Sick Children
6
Version Date: April 27, 2016
Select Export Data from the administration menu of SPW.
This will bring up the entire patient list; all files are selected by default. If you do not wish to
export all patient files in the database uncheck Patient Number (square) and then select the
files you wish to export.
Select Export Patient Files in upper right corner of the Export Screen (circle).
Select a pre-existing folder or make a new folder to store exported .spx files and
press ok.
Once complete a confirmation will appear in the Export Log at the bottom of the
export data page.
Multiple Breath Nitrogen Washout Testing
Site Training and Qualification Requirements
The Hospital for Sick Children
7
Version Date: April 27, 2016
Data Transfer
Study Data Submission Process – FTP Site
The MBW Centre will set-up an FTP account for each site.
This requires the e-mail address of the designated user from each site
Upon creation of the FTP account, Username and Password will be sent to the
designated user
Navigate to FTP site – https://ritftp.research.sickkids.ca
Log in with assigned Username and Password
User can then change password at first login
If you have trouble, please contact the MBW centre. Please DO NOT email
researchhelpdesk@sickkids.ca
Exported .spx files from all sites will be submitted for over-reading via a secure
file transfer protocol (FTP) hosted by SickKids Hospital.
Multiple Breath Nitrogen Washout Testing
Site Training and Qualification Requirements
The Hospital for Sick Children
8
Version Date: April 27, 2016
1. Select ‘New Upload’
2. Enter the Recipients’ emails
Email: mbw.centre@sickkids.ca
3. Enter ‘Short Note’
Please include the following in the Short Note section:
1. Name of subject file uploaded (i.e. 10.QS1).
2. Confirm whether MBW testing has been performed according to testing protocol
outlined in study specific SOP.
3. Any deviations to equipment or test procedure should be clearly indicated.
Multiple Breath Nitrogen Washout Testing
Site Training and Qualification Requirements
The Hospital for Sick Children
9
Version Date: April 27, 2016
4. Enter Password
mbwcentre
Multiple Breath Nitrogen Washout Testing
Site Training and Qualification Requirements
The Hospital for Sick Children
10
Version Date: April 27, 2016
5. Select ‘Choose Files’
6. Select the .spx file(s) to upload
7. Select ‘Start Upload’
Multiple Breath Nitrogen Washout Testing
Site Training and Qualification Requirements
The Hospital for Sick Children
11
Version Date: April 27, 2016
8. Upload Confirmation
Tracking number should be saved for site records
Sites will receive:
A confirmation e-mail from the FTP service that the file has been uploaded.
o Tracking number should be saved for site records.
E-mail notification from the FTP service when the file has been downloaded by the
MBW Centre.
Multiple Breath Nitrogen Washout Testing
Site Training and Qualification Requirements
The Hospital for Sick Children
12
Version Date: April 27, 2016
Site Feedback
Feedback to sites will include comments and suggestions aimed to emphasize and support
good practice and offer suggestions on improvement.
• Feedback will be provided to the sites on the quality of each transmission within 10
business days of receiving the confirmation email that that file has been
downloaded by the MBW Centre. Please note, during times when multiple sites are
qualifying to be part of a clinical trial, delays can be expected in receiving feedback.
Requirements for Successful Qualification Adult and Paediatric (6+ years)
8/10 successful test occasions (detailed criteria above); 4/5 per operator.
Each additional operator (over and above the initial two) will require 4/5 successful test
occasions.
Of the 4/5 successful test occasions per operator 2 must be CF patients, and 1 subject
must be in the range of the study population (i.e. paediatric sites must successfully
test at least 1 paediatric patient).
Requirements for Successful Qualification Preschool (3-6 years)
4/5* successful test occasions (detailed criteria above)
Of the 4 successful test occasions
2 must be CF patients
1 must be < 4 years old
*If more than 2 operators are submitting qualification data together please see details above.
Unsuccessful Qualification
If a site does not meet qualification requirements on the first attempt, they will be asked to
submit 5 additional MBWN2 qualification test occasions for evaluation.
4/5 additional MBWN2 qualification test occasions must be successful
The additional test occasions should be collected by the site operators whose
original submissions were unsuccessful.
Under circumstances where additional traces are also unsuccessful, further training may be
required. This will be addressed on a case by case basis.
Multiple Breath Nitrogen Washout Testing
Site Training and Qualification Requirements
The Hospital for Sick Children
13
Version Date: April 27, 2016
Training and Certification of additional operators:
Only certified operators will be qualified to perform MBW measurements for clinical trials. Any
new operator can register for an upcoming training session.
Dissemination of training materials to new operators within a site is up to the discretion of the
site. Additional operators may only be trained by a trained and certified operator, who is
experienced in testing and has demonstrated thorough understanding of test procedure
through a record of 80% success rate from at least 50 test occasions in the study population. To
train an operator in preschool testing, the trainer must have demonstrated an 80% success rate
from 50 preschool test occasions. It is the responsibility of the site to submit evidence of 50
successful test occasions to the MBW centre for consideration. Documentation of successful test
occasions can be found in the study QC reports sent by the MBW centre. Qualification trials do
not count towards the 50 successful test occasions.
New operators who are trained by an existing operator at their site must submit 5 qualification
test occasions with 4/5 successful test occasions in order to become certified for testing.
Qualification tests may be submitted to the central over-reading centre at any time.
top related