For RTOG 1221

MBS Modified Barium Swallow Study Form

RTOG 1221: Randomized Phase II Trial of Transoral Endoscopic Head And Neck Surgery followed by Risk-
Based IMRT and Weekly Cisplatin versus IMRT and Weekly Cisplatin for HPV Negative Oropharynx Cancer
INSTRUCTIONS: To be filled out by the speech pathologist after the modified barium swallow study.
Dates are recorded as mm-dd-yyyy unless otherwise specified.

MBS PROTOCOL:
All MBS studies must follow a standard protocol as outlined below.

Bolus trials (lateral view) outlined below MUST be administered first before any additional
consistencies are given or swallowing strategies/postures are tested. Additional bolus presentations or
swallowing strategies may be tested after completing bolus trials in the study protocol, at the discretion of
the clinician conducting the MBS study.

Studies will be done in lateral and AP views with focus fixed on the soft palate superiorly,
cricopharyngeus inferiorly, lips anteriorly, and cervical spine posteriorly.

Video-recordings will require time code imprints accurate to 0.01 seconds (30 frames/second).

Studies must be recorded in AVI or MPEG format with audio and uploaded to the RTOG coordinating
center website for review at (INSERT HYPERLINK). All centers must use the Kay Digital Swallowing
Workstation for the studies; or alternatively, have the ability to convert files to AVI of MPEG format.

Centers must use Varibar products. Consistencies and quantities are listed below. Liquids must be
administered first to avoid confounding the results from remaining residue in the pharynx after solid
consistencies.

A dime must be taped to the subject’s chin during the swallowing study. The circular shape of the dime
minimizes the impact of head rotation and the known diameter of the dime allows for calibration of pixels
per cm and thus calculation of distances and areas on the lateral view of the x-ray.

Lateral view (presented in the precise order listed below):

a) 5mL thin (2 trials, tsp). Instruction to the patient: please hold this in your mouth until asked to
swallow.
b) 20mL thin (1 trial). Instruction to the patient: please try to take the whole amount and hold it in
your mouth until I ask you to swallow. Self administration is optimal, but clinician administration is
acceptable.
c) 5mL pudding (1 trial tsp). Instruction: swallow when you are ready.
d) 1/2 cookie or cracker, barium coated - coated with 3 ml (1/2 tsp) of Varibar pudding (1 trial).
Instruction to the patient: chew this up and swallow when you feel comfortable and ready to
swallow.

A-P view:
10mL thin (1 trial). Instruction: slightly raise your chin (neutral position, not tucked or extended), hold this
in your mouth until asked to

RATING RULES: Rate MBS outcomes below ONLY on the basis of the 5 bolus trials presented in
the lateral view of RTOG protocol (specified above): 5mL Varibar thin liquid (2 trials), 20 mL Varibar
MBS Modified Barium Swallow Study Form
RTOG 1221: Randomized Phase II Trial of Transoral Endoscopic Head And Neck Surgery followed by Risk-
Based IMRT and Weekly Cisplatin versus IMRT and Weekly Cisplatin for HPV Negative Oropharynx Cancer
thin liquid, 5mL Varibar pudding, and ½ cookie or cracker coated in 3mL Varibar pudding. Do not rate
based on additional bolus trials that are administered outside of the protocol or based on bolus trials in
which a swallow strategy/posture was tested. Please select a SUMMARY RATING based on the highest
level of impairment you observe on any bolus trial in the protocol.

1 DATE OF MBS _____-_____-_____

2 □TIME OF MBS
1 Baseline
2 After surgery (before adjuvant therapy)
3 Six months after treatment
4 Twenty-four months after treatment
Scoring Rules
(Rate the worst of
Outcome Variables Definition impairment across all Rating
bolus trials in the MBS
protocol)
3 LARYNGEAL PENETRATION: Bolus Select “1” if LARYNGEAL
enters the larynx but PENETRATION occurred on □ No penetration (0)
PENETRATION does not pass below the any bolus in the protocol. □ Penetration (1)
TVFs
4 ASPIRATION ASPIRATION: Bolus enters Select the highest level of
the larynx and passes aspiration that occurred
below the TVFs. during the protocol.
□ No aspiration (0)
SENSATE: attempts to eject Select “1” if SENSATE
aspirate from airway ASPIRATION ocurred on □ Yes, sensate (1)
(e.g., cough, throat any bolus in the protocol, but
clear) silent aspiration NEVER □ Yes, silent (2)
occurred.
SILENT: no effort to eject
aspirate from airway (no Select “2” if SILENT
cough, throat clear) ASPIRATION occurred on
any bolus in the protocol.
5 PHARYNGEAL RESIDUE: bolus remaining Rate the highest level of
on or within the pharynx residue that occurred during
RESIDUE at the conclusion of the the protocol.
initial swallow. The
conclusion of the initial Select “0” is no residue or
swallow is when the only pharyngeal coating
hyoid bone returns to occurred during the protocol. □ No residue (0)
rest. If the patient
spontaneously swallows Select “1” if pharyngeal □ <50% pharyngeal
several times to clear the residue of <50% of the residue (1)
bolus, residue is rated original bolus remained in
st
after the 1 swallow the pharynx on any bolus in □ ≥ 50% pharyngeal
attempt. the protocol. residue (2)

Select “2” if pharyngeal

residue of half or more of the
original bolus remained in
the pharynx on any bolus in
the protocol.
MBS Modified Barium Swallow Study Form
RTOG 1221: Randomized Phase II Trial of Transoral Endoscopic Head And Neck Surgery followed by Risk-
Based IMRT and Weekly Cisplatin versus IMRT and Weekly Cisplatin for HPV Negative Oropharynx Cancer

PERSON COMPLETING MBS:

Credentials: □ CF-SLP (specify name/credentials of supervisor: )
□ CCC-SLP □ BRS-S