Supplemental Digital Content (SDC) 1. Symptom Assessment

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Supplemental Digital Content (SDC) 1. Symptom Assessment/Grading table.
Symptom Assessment/Grading
General/Constitutional:
ECOG
0--fully active, able to carry on all pre-disease performance w/o restriction
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% of waking hrs
3--capable of only limited self-care, confined to bed or chair more than 50% of waking hrs
4--completely disabled, cannot carry on any self-care, totally confined to bed or chair
5--dead
Fatigue
0--none
1--fatigue relieved by rest
2--fatigue not relieved by rest, limiting instrumental ADL
3--fatigue not relieved by rest, limiting self-care ADL
Anorexia
0--none
1--loss of appetite w/o alteration in eating habits
2--oral intake altered w/o sig. wt loss or malnutrition; oral nutritional supplements indicated
3--associated w/ sig. wt loss or malnutrition (e.g. inadequate oral caloric and/or fluid intake);
tube feeding or TPN indicated
4--life-threatening consequences; urgent intervention indicated
5--death
Neurological/Psychiatric:
Oriented to: person, place, time
Depressed level of consciousness
0--none
1--decreased level of alertness
2--sedation; slow response to stimuli; limiting instrumental ADL
3--difficult to arouse
4--life-threatening consequences
5—death
Cognitive disturbance
0--none
1--mild cognitive disability; not interfering with work/school/life performance; specialized
educational services/devices not indicated
2--moderate cognitive disability; interfering with work/school/life performance but capable of
independent living; specialized resources on part time basis
3--severe cognitive disability, significant impairment of work/school/life performance
SDC 1 (continued). Symptom Assessment/Grading table.
Headache
0--none
1--mild pain
2--moderate pain; limiting instrumental ADL
3--severe pain, limiting self-care ADL
Vision changes: no, yes
Hearing changes: no, yes
Seizure
0--none
1--brief partial seizure; no LOC
2--brief generalized seizure
3--multiple seizures despite medical intervention
4--life-threatening; prolonged repetitive seizures
5—death
Dysarthria
0--none
1--mild slurred speech
2--moderate impairment of articulation or slurred speech
3--severe impairment of articulation or slurred speech
Dysphagia
0--none
1--awareness of receptive or expressive characteristics; not impairing ability to communicate
2--moderate receptive or expressive characteristics, impairing ability to communicate
spontaneously
3--severe receptive or expressive characteristics, impairing ability to read, write, or
communicate intelligibly.
Facial muscle weakness
0--none
1--asymptomatic, clinical or diagnostic observations only, intervention not indicated
2--moderate, limiting instrumental ADL
3--severe, limiting self-care ADL
Other muscle weakness
0--none
1--symptomatic, weakness perceived by patient and not evident on physical exam
2--symptomatic, weakness evident on physical exam, weakness limiting instrumental ADL
3--weakness limiting self-care ADL, disabling
SDC 1 (continued). Symptom Assessment/Grading table.
Ataxia
0--none
1--asymptomatic, clinical or diagnostic observations only, intervention not indicated
2--moderate, limiting instrumental ADL
3--severe, limiting self-care ADL, mechanical assistance indicated
Paresthesia
0--none
1--mild symptoms
2--moderate, limiting instrumental ADL
3--severe, limiting self-care ADL
Insomnia
0--none
1--mild difficulty falling asleep, staying asleep, or waking up early
2--moderate difficulty falling asleep, staying asleep, or waking up early
3--severe difficulty in falling asleep, staying asleep, or waking up early
Depression
0--none
1--mild depressive symptoms
2--moderate depressive, limiting instrumental ADL
3--severe depressive, limiting self-care ADL, hospitalization not indicated
4--life-threatening consequences threats of harm to self or others, hospitalization indicated
5--death
Gastrointestinal:
Constipation
0--none
1-occasional or intermittent, occasional use of stool softeners, laxatives, dietary modification,
or enema
2--persistent with regular use of laxatives or enemas, limiting instrumental ADL
3--obstipation with manual evacuation indicated, limiting self-care ADL
4--life-threatening consequences, urgent intervention indicated
5--death
Nausea
0--none
1--loss of appetite without alteration in eating habits
2--oral intake decreased w/o significant wt. loss, dehydration, or malnutrition
3--inadequate oral caloric or fluid intake, tube feeding, TPN, or hospitalization indicated
SDC 1 (continued). Symptom Assessment/Grading table.
Vomiting
0--none
1--1-2 episodes (separated by 5 min) in 24 hrs
2--3-5 episodes (separated by 5 min) in 24 hrs
3-- >=6 episodes(separated by 5 min) in 24 hrs, tube feeding, TPN, or hospitalization indicated
4--life-threatening consequences, urgent intervention indicated
5--death
Diarrhea
0--none
1--increase of <4stools per day over baseline, mild increase in ostomy output compared to
baseline
2--increase of 4-6 stools per day over baseline, moderate increase in ostomy output compared
to baseline
3--increase of >=7 stools per day over baseline, incontinence, hospitalization indicated, severe
increase in ostomy output compared to baseline, limiting self-care ADL
4--life-threatening consequences, urgent intervention indicated
5--death
Fecal incontinence
0--none
1--occasional use of pads required
2--daily use of pads required
3--severe, elective operative intervention indicated
Genitourinary:
Urinary incontinence
0--none
1--occasional (e.g. with coughing, sneezing, etc.), pads not indicated
2--spontaneous, pads indicated, limiting instrumental ADL
3--intervention indicated (e.g. clamp, collagen injections), operative intervention indicated,
limiting self-care ADL
Skin:
Radiation dermatitis
0--none
1--faint erythema or dry desquamation
2--moderate to brisk erythema, patchy moist desquamation, mostly confined to skin folds and
creases, moderate edema
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
SDC 1 (continued). Symptom Assessment/Grading table.
Skin sensation
0--none
1--itching
2--burning
3--painful
Alopecia
0--none
1--hair loss of <50% of normal for that individual that is not obvious from a distance but only
on close inspection, a different hair style may be required
2--hair loss of >=50% normal for that individual that is readily apparent to others, a wig or hair
piece is necessary if the patient desires to completely camouflage the hair loss; associated with
psychosocial impact
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