multiple breath nitrogen washout testing site training...

Multiple Breath Nitrogen Washout Testing

Site Training and Qualification Requirements

The Hospital for Sick Children

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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:

[email protected]

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.




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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




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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.




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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([email protected])




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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***




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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.




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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

[email protected]

Exported .spx files from all sites will be submitted for over-reading via a secure

file transfer protocol (FTP) hosted by SickKids Hospital.

https://ritftp.research.sickkids.ca/

https://ritftp.research.sickkids.ca/




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1. Select ‘New Upload’

2. Enter the Recipients’ emails

Email: [email protected]

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.

mailto:[email protected]




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4. Enter Password

mbwcentre




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5. Select ‘Choose Files’

6. Select the .spx file(s) to upload

7. Select ‘Start Upload’




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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.




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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.




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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.

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