Electronic supplementary material

The development of an ICF-based clinical guideline and screening tool for the standardized
assessment and evaluation of functioning after head and neck cancer treatment

Ulrich Kisser, Christine Adderson-Kisser, Michaela Coenen, Marita Stier-Jarmer, Sven Becker, Carla
Sabariego, Ulrich Harréus

Corresponding author:
Dr. Ulrich Kisser
Department of Otorhinolaryngology, Head and Neck Surgery
Ludwig-Maximilians-Universität (LMU) München
Email: Ulrich.Kisser@med.uni-muenchen.de

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Content of the computer-based screening tool: detailed overview

Part I Patient-reported outcome

Food intake, swallowing

_____ (in kg)
Current weight
_____ (in cm)
weight
Body

Body height
_____ kg lost;
Weight loss during last two months
no weight loss

To what extent are the following scenarios problematic for you?

Eating Assessment Tool (EAT-10)

1. My swallowing problem has caused me to lose weight.

2. My swallowing problem interferes with my ability to go out for meals.
3. Swallowing liquids takes extra effort.
4. Swallowing solids takes extra effort. 1 2 3 4§
Eating

5. Swallowing pills takes extra effort. No Severe

6. Swallowing is painful. problem problem
7. The pleasure of eating is affected by my swallowing.
8. When I swallow food sticks in my throat.
9. I cough when I eat.
10. Swallowing is stressful.

Psychosocial aspects
EORTC Quality
General health /

Questionnaire -

For the following questions please circle the number between 1 and 7 that best
quality of life

QLQ-C30

applies to you
of Life

0 1 2 3 4 5 6 7§
Very poor Excellent
How would you rate your overall health during the past week?
How would you rate your overall quality of life during the past week?
EORTC Quality

Questionnaire –

During the past week:

QLQ-C30

1 2 3 4§
Fatigue

of Life

Did you need to rest? Not A Quite Very

Have you felt weak? at all little a bit much
Were you tired?

Over the last 2 weeks, how often have you been bothered by the following
Generalized

1 2 3 4§
Disorder –

problems?
Anxiety
Anxiety

GAD-2

Not Several More Nearly

at all days than half every
Feeling nervous, anxious, or on edge the days day
Not being able to stop or control worrying

Over the last 2 weeks, how often have you been bothered by any of the
Patient Health Questionnaire – PHQ-9

following problems?
Little interest or pleasure in doing things
Feeling down, depressed, or hopeless
Trouble falling or staying asleep, or sleeping too much 1 2 3 4§
Depression

Feeling tired or having little energy Not Several More Nearly

Poor appetite or overeating at all days than half every
the days day
Feeling about yourself – or that you are a failure or have let yourself or your
family down
Trouble concentrating on things, such as reading the newspaper or watching television
Moving or speaking so slowly that other people could have noticed? Or the opposite –
being so fidgety or restless that you have been moving around a lot more than usual
Thoughts that you would be better off dead or of hurting yourself in some way

How much difficulty do you have in the following areas?

Social Score – short

1. coping with consequences of the disease

Participation:

2. handling social law questions 0 1 2 3§

version

No Severe
3. coping with every-day life /self-care problem problem
4. with family/social surroundings
5. with financial/economic issues
6. in work life

Pain
Please circle the number that best describes your average pain 0 1 2 3 4 5 6 7 8 9 10
Numeric
rating
scale
Pain

No Worst possible
pain pain
§
Response options are shown only once per aspect.

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Part II Clinician’s evaluation

Food intake, swallowing

Clinical evaluation of nasogastric tube
Use of
tube

yes no
Clinical evaluation of percutaneous endoscopic gastrostomy tube

Clinical assessment of dental status (status, dentition, dental occlusion, oral

Dental

Action required
status

hygiene) yes no

Voice, speech, breathing

Action required
Clinical assessment of voice and speech yes no
Therapy control
1 - ---
2 - Localized; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral)
Wound infection 3 - IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated
4 - Life-threatening consequences; urgent intervention indicated
5 - Death
Definition: A disorder characterized by an infectious process involving the wound

1 - ---
2 - Local wound care; medical intervention indicated (e.g., dressings or topical medications)
Head soft tissue necrosis 3 - Operative debridement or other invasive intervention indicated (e.g., tissue reconstruction, flap or grafting)
4 - Life-threatening consequences; urgent intervention indicated
5 - Death
Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the head.

1 –Asymptomatic or mild symptoms; intervention not indicated

2 - Moderate pain; not interfering with oral intake; modified diet indicated
Mucositis oral 3 - Severe pain; interfering with oral intake
4 - Life-threatening consequences; urgent intervention indicated
5 - Death
Definition: A disorder characterized by inflammation of the oral mucosal.
Common Terminology Criteria for Adverse Events – CTCAE

1 – Symptomatic, able to eat regular diet

2 - Symptomatic and altered eating/swallowing )
Dysphagia 3 - Severely altered eating/swallowing; tube feeding or TPN or hospitalization indicated
4 - Life-threatening consequences; urgent intervention indicated
5 - Death
Definition: A disorder characterized by difficulty in swallowing

1 – Increased oral fluids indicated; dry mucous membranes; diminished skin turgor
2 - IV fluids indicated <24 hrs
Adverse events

Dehydration 3 - IV fluids or hospitalization indicated

4 - Life-threatening consequences; urgent intervention indicated
5 - Death
Definition: A disorder characterized by excessive loss of water from the body. It is usually caused by severe diarrhea, vomiting or diaphoresis.

1 – Detectable airway noise with minimal symptoms

2 - Moderate symptoms; medical intervention indicated; limiting instrumental ADL
Wheezing 3 - Severe respiratory symptoms limiting self-care ADL; oxygen therapy or hospitalization indicated
4 - Life-threatening consequences; urgent intervention indicated
5 - Death
Definition: A disorder characterized by a high-pitched, whistling sound during breathing. It results from the narrowing or obstruction of the respiratory
airways.

1 - Faint erythema or dry desquamation

2 - Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate
edema
Dermatitis radiation 3 - Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion
4 - Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from
involved site; skin graft indicated
5 - Death
Definition: A finding of cutaneous inflammatory reaction occurring as a result of exposure to biologically effective levels of ionizing radiation.

1 - Asymptomatic localized neck edema

2 - Moderate neck edema; slight obliteration of anatomic landmarks; limiting instrumental ADL
Neck edema 3 - Generalized neck edema (e.g., difficulty in turning neck); limiting self care ADL
4 - ---
5 - ---
Definition: A disorder characterized by swelling due to an accumulation of excessive fluid in the neck.

1 - Mild or intermittent change from normal voice

2 - Moderate or persistent change from normal voice; still understandable
Voice alteration 3 - Severe voice changes including predominantly whispered speech; may require frequent repetition or face-to-face
contact for understandability; may require assistive technology
4 - ---
5 - ---
Definition: A disorder characterized by a change in the sound and/or speed of the voice.

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 1 - Symptomatic (e.g., dry or thick saliva) without significant dietary alteration; unstimulated saliva flow >0.2
ml/min
2 - Moderate symptoms; oral intake alterations (e.g., copious water, other lubricants, diet limited to purees and/or
Dry mouth soft, moist foods); unstimulated saliva 0.1 to 0.2 ml/min
3 - Inability to adequately aliment orally; tube feeding or TPN indicated; unstimulated saliva <0.1 ml/min
4 - ---
5 - ---
Definition: A disorder characterized by reduced salivary flow in the oral cavity.

1 - Altered taste but no change in diet

2 - Altered taste with change in diet (e.g., oral supplements); noxious or unpleasant taste; loss of taste
Dysgeusia 3 - ---
4 - ---
5 - ---
Definition: A disorder characterized by abnormal sensual experience with the taste of foodstuffs; it can be related to a decrease in the sense of smell.
1 - Mild; intervention not indicated
Common Terminology Criteria for Adverse Events – CTCAE

2 - Moderate symptoms; medical intervention or minor cauterization indicated

3 - Transfusion, radiologic, endoscopic, or elective operative intervention indicated
4 - Life-threatening consequences; urgent intervention indicated
Bleeding 5 – Death

Others _______
Adverse events

1 - Asymptomatic; clinical or diagnostic observations only; intervention not indicated

2 - Symptomatic; altered GI function
Oral cavity fistula 3 - Severely altered GI function; TPN or hospitalization indicated; elective operative intervention indicated
4 - Life-threatening consequences; urgent intervention indicated
5 - Death
Definition: A disorder characterized by an abnormal communication between the oral cavity and another organ or anatomic site.

1 - Asymptomatic; clinical or diagnostic observations only; intervention not indicated

2 - Symptomatic; tube thoracostomy or medical intervention indicated; limiting instrumental ADL
Pharyngeal fistula 3 - Severe symptoms; limiting self care ADL; endoscopic or operative intervention indicated (e.g., stent or primary
closure)
4 - Life-threatening consequences; urgent intervention indicated
5 - Death
Definition: A disorder characterized by an abnormal communication between the pharynx and another organ or anatomic site.

1 - Asymptomatic; clinical or diagnostic observations only; intervention not indicated

2 - Symptomatic; tube thoracostomy or medical management indicated; limiting instrumental ADL
3 - Severe symptoms; limiting self care ADL; endoscopic or operative intervention indicated (e.g., stent or primary
Laryngeal fistula closure)
4 - Life-threatening consequences; urgent operative intervention indicated (e.g., thoracoplasty, chronic open drainage
or multiple thoracotomies)
5 - Death
Definition: A disorder characterized by an abnormal communication between the larynx and another organ or anatomic site.

1 - Asymptomatic; clinical or diagnostic observations only; intervention not indicated

2 - Symptomatic (e.g., noisy airway breathing), but causing no respiratory distress; medical management indicated
Pharyngeal stenosis (e.g., steroids); limiting instrumental ADL
3 - Limiting self care ADL; stridor; endoscopic intervention indicated (e.g., stent, laser)
4 - Life-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)
5 - Death
Definition: A disorder characterized by a narrowing of the pharyngeal airway.

1 - Asymptomatic; clinical or diagnostic observations only; intervention not indicated

2 - Symptomatic (e.g., noisy airway breathing), but causing no respiratory distress; medical management indicated
Tracheal stenosis (e.g., steroids)
3 - Stridor or respiratory distress limiting self care ADL; endoscopic intervention indicated (e.g., stent, laser)
4 - Life-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)
5 - Death
Definition: A disorder characterized by a narrowing of the trachea.

1 - Asymptomatic; clinical or diagnostic observations only; intervention not indicated

2 - Symptomatic; altered GI function
Esophageal stenosis 3 - Severely altered GI function; tube feeding; hospitalization indicated; elective operative intervention indicated
4 - Life-threatening consequences; urgent operative intervention indicated
5 - Death
Definition: A disorder characterized by a narrowing of the lumen of the esophagus.

1 - Decreased ROM (range of motion) without impaired eating

2 - Decreased ROM requiring small bites, soft foods or purees
Trismus 3 - Decreased ROM with inability to adequately aliment or hydrate orally
4 - ---
5 - ---
Definition: A disorder characterized by lack of ability to open the mouth fully due to a decrease in the range of motion of the muscles of mastication.

Other adverse events (not classified above) _________________________________________________

Eastern Cooperative Oncology

0 - Fully active, able to carry on all pre-disease performance without restriction

Group (ECOG) Scale
Performance Status

1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary
nature, e.g., light house work, office work
2 - Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50%
Patient’s status of waking hours
3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
5 – Death