Download MedView ver.XIII20090604

1
MedView record for The Ora-Stem Study. Date for this version: 090604
Prerequisites:
- Special Multicenter MedView study file that can be reached via Internet.
- Each patient coded. Each patient identification to be kept by treating center until the
patient has passed through the whole study, then destroyed. The patient can not be
identified by others.
- For some questions we have fixed answers, for some we can answer in our own words
and for some questions we can make new answers that will end up in a drop down list.
QUESTIONS
PHASE I. BASELINE DATA
Pre-Tx examination
(8 weeks – 1 day before Tx)
Demographics
What age is the patient at first visit?
What gender?
What race?
Medical diagnosis and treatment
Medical diagnosis requiring transplant?
WHO diagnosis by International Classification
of Diseases (ICD-10)
- in around 40 languages
What oncology treatment is planned?
SPECIFICATIONS/CHOICES
Drop down list
18-90 years
Male
Female
White or caucasian
Black or African American
East Asia
West Asia
Pacific Islander
Other race
Drop down list:
Acute lymphatic leukaemia (ALL);
Recurrent ALL;
Acute myeloid leukaemia (AML);
Recurrent AML;
Myelodysplastic syndrome (MDS);
Myeloma
Hodgkin Lymphoma,
Non-Hodgkin Lymphoma
-Indolent (lågmaligna) lymphoma
-Aggressive (högmaligna)
lymphoma
Conditioning regimen?
Drop down list:
Allogeneic, unrelated donor
Allogeneic, related donor
Autologous
Cord blood transplant
Write down the regimen
Total Body Irradiation regimen?
No
Yes
2
Earlier chemotherapy within last year
Earlier RT to Head & Neck?
Notes
Patient history of oral problems during cancer
therapy preceding BMT
Past medical history (general medical
problems) based on patient report and
medical record
Past medical conditions
Current medical conditions
Current medication (Observe, only list Generics)
Environmental allergies
Drug allergies
Current bleeding problems/disturbances
(list can be extended)
Smoking habits
Smoking habits, frequency
Smokeless tobacco (snuff) use
Alcohol habits
No
No
Yes
Yes
Drop down list
Start by filling in text – leading to
drop down list eventually
Start by filling in text – leading to
drop down list eventually
Drop down list of generic names
Long list of allergens
Long list of drugs
No
Yes,
due to: (drop down list)
Cancer chemotherapy
Haemophilia
Liver cirrhoses
Anticoagulants
Thrombocytopenia
No, never
# years ago (Previous smoker)
Not daily
Yes, daily
# cigarettes/day
# cigars/days
# years
No never
Not daily
# doses/day, packed
# doses/day, unpacked
No, never use alcohol
Yes
# alcohol equivalents/week
(1 alcohol equivalent =
1½ ounce (4.4 cl) distilled spirits
or
1 glass (5 ounces=15 cl) wine or
1 glass (12 ounces=35 cl) beer
Pack years
be
calculated
later
3
Patient reports of general oral problems
How does your mouth feel right now?
Ok, no symptoms.
Do you have oral symptoms right now?
Not ok, having
(List can be extended).
symptoms
List as below
Have you had any other symptoms from the oral No
Yes
cavity for the last 6 months (history)?
(List can be extended).
How often do you routinely brush your mouth?
How often do you see a dentist or dental
therapist?
Complete full oral exam including
Dental charting (restorations, caries,
Periodontal charting (such as pocket depths if
possible)
Radiographs
For how long have
they lasted?
(separate answer
for each symptom)
Teeth:
Mucosa:
Decay to
Tenderness:
dentin
Mucositis;
(caries);
Bleeding
Food
(gingival);
impaction; Bleeding
Grinding
(other
(Bruxism); mucosal);
Sensitive
Blisters/ulcer
teeth (e.g.
s;
hot or cold Canker sore
sensitivity), (Aphthae);
Filling
Cold sore
fracture;
(Herpes
Tooth
labialis);
ache,
Intraoral
Tooth
herpes;
infection;
Coated
toothfract- tongue;
ures;
Haematoma,
Oral
Thrush
swelling
(fungal
from
infection);
infected
Burning
tooth,
sensation;
Pericoro“Sand paper
nitis
feeling”
3 or more times/day
Twice/day
Once/day
< once/day – once/week
< once/week
Routinely
Only for acute problems
Never
Others:
Allergic
reaction;
Bad taste;
Hoarseness;
Taste changes;
Vomiting
reflexes,
Dry Mouth;
Diffuse pain
----
4
Photos taken
Pictures with dates added
5
PHASE II
Admission clinical examination
(sometimes in the ward)
(days -7 to -1)
Day before transplantation?
Oral examination
MUCOSA
Mucosal disease, tentative (preliminary) clinical
diagnosis
WHO Mucositis Score
(only WHO scale at this point)
Description of mucosal disease, not mucositis
(multiple diseases should be described
separately)
- Location of mucosal disease
- Colour
- Mucosal texture
-7, -6, -5, -4, -3, -2, -1
Dropdown list:
Lichen planus,
Leukoplakia, unknown cause,
Lesion from smokeless tobacco
Geographic tongue,
Coated tongue;
Hairy tongue,
Cancer sore (aphthae),
Pemphigoid,
Mucositis;
Haematoma,
Herpes Simplex
Viral infection, other
Fungal infection
Bacterial infection
other…
Grade 0: No findings or erythema only
Grade 1: soreness present with or
without erythema
Grade 2: Ulcers present but able to take
solid food
Grade 3: Ulcers present and only able to
take liquids
Grade 4: Ulcers present/not able to take
anything orally
Drop down list
Normal
Pale
Blue
Brown
Grey
Yellow
Dark
Red
White
Blister
Bleeding
Petecciae
6
Subcutaneous bleeding
Exostosis
Fissure
Fistula
Granuloma
Hyperplasia
Scalloping
Leukoedema
Necrosis
Pigmentation
Striae
Ulcer
Swollen
Vesical
Scaring
- size
Diagnostic tests completed at today’s
appointment
Drop down list
Bacterial
Viral
Fungal
Biopsy
Results
ORAL SYMPTOMS FORM
See special form
TEETH
Total number of remaining teeth with natural
root (with or without crown)
#
Total number of dental implants
#
Total number of teeth with manifest caries
(D3; decayed to dentine) left untreated
(calibration between centers needed)
None
1-3 teeth
4-6 teeth
>6 teeth
# teeth
(0,1,2,3,4,5,6,7,8,9,10,11, 12,
>12)
# teeth
(0,1,2,3,4,5,6,7,8,9,10,11, 12,
>12)
Total number of teeth decayed to pulp left
untreated
Total number of completed root canal treated
teeth, regardless of quality
Total number of teeth with root canal treatment
started but not completed
Total number and asymptomatic teeth with
radiographic evidence of periapical lesions
(apical periodontitis)
Please indicate tooth number position by nonUS standard (18 for upper right wisdom tooth)
Tooth number positions
*Can be
scare or
active
processes
7
Total number and symptomatic teeth with
radiographic evidence of periapical lesions
(apical periodontitis)
Please indicate tooth number position by nonUS standard (18 for upper right wisdom tooth)
Fully impacted teeth
(covered with bone; fully covered with mucosa)
Tooth number positions
No
Tooth numbers
European
Partially Impacted teeth
(can be seen or felt with a probe)
PERIODONTIUM
Total number of remaining teeth with at least
one pocket depth ≥ 6 mm (based on periodontal
exam within previous 8 weeks)
Debris Index simplified (DI-S)
according to Greene and Vermillion, 1964)
The 6 surfaces examined are selected from 4
posterior and 2 anterior teeth.
- In the posterior portion of the dentition,
the first fully erupted tooth distal to the
second bicuspid (15), usually the first
molar (16), but sometimes the second
molar (17) or third molar (18) is
examined. The buccal surfaces of the
selected upper molar and the lingual
surfaces of the selected lower molars are
inspected.
- In the anterior portion of the mouth, the
labial surfaces of the upper right (11) and
the lower left central incisors (13) are
scored. In the absence of either of these
anterior teeth, the central incisor (21 or
41, respectively) on the opposite side of
the midline is substituted.
Calculus Index simplified (CI-S)
according to Greene and Vermillion, 1964
http://www.whocollab.od.mah.se/expl/ohisgv64.
html
The 6 surfaces examined are selected from 4
posterior and 2 anterior teeth.
- In the posterior portion of the dentition,
the first fully erupted tooth distal to the
second bicuspid (15), usually the first
molar (16), but sometimes the second
molar (17) or third molar (18) is
(translated to
American)
No
Tooth numbers
European
Yes
Yes
(translated to
American)
Grade 0 = No debris or stain
present
Grade 1 = Soft debris covering
not more than 1/3 of the tooth
surface or presence of extrinsic
stains without other debris
regardless of surface area
covered.
Grade 2 = Soft debris covering
more than 1/3 but not more
than 2/3 of the exposed tooth
surface.
Grade 3 = Soft debris covering
more than 2/3 of the exposed
tooth surface.
Grade 0 = No calculus present
Grade 1 = Supragingival
calculus covering not more
than one third of the exposed
tooth surface.
Grade 2 = Supragingival
calculus covering more than
one third but not more than two
thirds of the exposed tooth
surface or the presence of
individual flecks of subgingival
calculus around the cervical
8
-
examined. The buccal surfaces of the
selected upper molar and the lingual
surfaces of the selected lower molars are
inspected.
In the anterior portion of the mouth, the
labial surfaces of the upper right (11) and
the lower left central incisors (13) are
scored. In the absence of either of these
anterior teeth, the central incisor (21 or
41, respectively) on the opposite side of
the midline is substituted.
portion of the tooth or both.
Grade 3 = Supragingival
calculus covering more than
two third of the exposed tooth
surface or a continuos heavy
band of subgingival calculus
around the cervical portion of
the tooth or both.
Total number of teeth with mobility grade III
# of teeth
(>1 mm displacement horizontally from a central
position combined with displacement in vertical
direction (intrusion))
Notes
(Example: Other radiographic pathology except
caries, perio, periapical lesions)
Dental treatment plan
Other chronic dental disease recommended to be
left untreated prior to transplantation
text
9
Acute oral problems
Drop down list can be extended
Oral care regimen
Is institution specific standard oral care regimen
reviewed to patient?
List special oral care recommendation to this
patient that supplements institution specific
standard oral care regimen
Medication
Complete list of current medication
To be filled in by medical personal if possible
Most recent lab test values
Blood-HGB (ref. 116-166 g/L or 12-17 d/dL)
Total white blood cell count – WBC (Ref. 3.5 –
9.0 x 109/L)
Total trombocyte count, Blood - PTL (Rev. 150350 x 109 /L
Notes (e.g. other significant lab. abnormalities)
Weight,
Height
Teeth:
Decay to dentin (caries);
Food impaction;
Grinding (Bruxism);
‘Sensitive teeth (e.g. hot or cold
sensitivity),
Filling fracture;
Tooth ache,
Tooth infection;
tooth fracture;
Oral swelling from infected tooth,
Chronice apical lesions;
Abscess;
Pericoronitis
Other tissues
Pain with muscles and mastication
(e.g. Masseter)
No
Yes, by dentist or dental hygienist
Yes, by nursing staff
text
acyclovir,
valacyclovir
CMV-prophylaxis
fluconazole,
nystatin rinse,
amphotericin B local,
amphotericin B systemic
Cephalosporin
Bactrim
V-penicillin
Others (fill in)
Value
Days old
Presc
ript.
durati
on
10
Temp.
Photos taken
Pictures with dates added
11
PHASE III
Visit by dentist Monday, Wednesday,
Friday during Inpatient Treatment
period in the ward:
1) Until “take” (bone marrow recovery)
if no oral problems then or
2) until resolution of oral problems up
to 6 weeks after Tx (day 0)
Day before/after transplantation?
Type of examination
Symptoms/Open questions
Do you have any symptoms/anything that
bothers you in the oral cavity today?
Please describe!
What is the worst/most bothersome oral
symptom right now?
In general (overall), how difficult are the oral
symptoms now?
Objectively (dentist)
Are symptoms in the oral cavity better/worse
than at last visit?
(indicate if patient is deteriorating or healing)
Subjectively (patient)
Are symptoms in the oral cavity better/worse
than at last visit?
(indicate if patient is deteriorating or healing)
Do you have any symptoms/anything that
bothers you in the throat?
Please describe!
What is the worst/most bothersome symptom in
your throat right now?
In general (overall), how difficult are the
symptoms from the throat now?
ORAL SYMPTOMS FORM
Symptoms/Validated symptoms scales
-7, -6, -5, -4, -3, -2, -1,
1,2,3,4,5,7,8,9,10,11,12,13,14,15,16,
- Study bed-side visits (i.e. 3 days a
week Monday-Wednesday-Friday)
- Not study visit
No
Yes
Drop down list
bleeding, saliva thick, saliva
“sticky”, “sand paper/raw feeling”,
swollen, dryness,
teeth tenderness/sensitivity,
tenderness/sensitivity in mucosa
tooth ache
pain
VAS 1-10
0 = none
10 = unbearable
Better
worse
completely healed
unchanged
Better
worse
completely healed
unchanged
VAS 0-10
0 = none
10 = unbearable
See special form
12
Asked by dentist or nursing staff Monday,
Wednesday, Friday
(Pain, Xerostomia, Dysgeusia, Dysphagia)
Oral examination
Mucosal disease, tentative clinical diagnosis
Can the patient eat?
WHO Mucositis Score
(Please observe: It has to be because of
problems with the mouth)
OMAS Mucositis Score
Dropdown list:
Lichen planus,
geographic tongue,
leukoplakia from unknown cause,
lesion from smokeless tobacco,
pemphigoid,
aphthae,
other…
herpes simplex
Viral infection, other
Fungal infection
Bacterial infection
GVH
Solid food
Liquid food (passerad kost)
Would be able to eat solid food if
not due to
- stomach
- throat
- loss of appetite
- nausea
- mouth?
Would be able to eat liquid food if
not due to
- stomach
- throat
- loss of appetite
- nausea
- mouth?
Grade 0: No findings or erythema
only
Grade 1: soreness present with or
without erythema
Grade 2: Ulcers present but able to
take solid food
Grade 3: Ulcers present and only
able to take liquids
Grade 4: Ulcers present/not able to
take anything orally
Ulceration/pseudomembrane
0 (no lesion)
1 (≤ 1 cm2)
2 (1-3 cm2)
3 (≥ 3 cm2)
Erythema
13
Sonis et al Validation of a new scoring
system for the assessment of clinical
trial research of oral mucositis
induced by radiation or chemotherapy.
Cancer 1999 May 15;85(10):2103-13.
0 (None)
1 (not severe)
2 (severe)
Location
ORAL SYMPTOMS FORM
GVHD
Description of mucosal disease
Location of mucosal disease
Colour
Mucosal texture
- Size?
Management of dental/oral problems
New drug treatment for oral problems now? (by
dentist or physician)
Se special form
Yes
No
Normal
Pale
Blue
Brown
Grey
Yellow
Dark
Red
White
Drop down list
Blister
Bleeding
Petecciae
Submucosal hemorrhage
Exostosis
Fissure
Fistula
Granuloma
Hyperplasia
Scalloping
Leukoedema
Necrosis
Pigmentation
Striae
Ulcer
Swollen
Vescical
Scaring
Long list of dental/oral treatments
(drop down)
Rinsing for pericoronitis
Grinding of sharp of edges
Xxxx
Xx
Long list of medications (e.g.
fluconazole for fungal, acyclovir for
viral infection, morphine for oral
pain, antibiotics for oral bacterial
infection)
14
Diagnostic tests completed at today’s
appointment
Oral care regimen
List special recommendation above institution
specific standard oral care regimen)
Medication
Complete list of current medication
To be filled in by medical personal if possible
Drop down list
bacterial
virus test
fungal
biopsy
Results
Discontinue brushing due to oral
pain
Discontinue brushing due to nausea
Chlorhexidine
others
acyclovir,
valacyclovir
CMV-prophylaxis
others (fill in)
fluconazole,
nystatin rinse,
amphotericin B local,
amphotericin B systemic
Cephalosporin
Bactrim
V-penicillin
Documented each time
?
Most recent lab test values
Blood-HGB (ref. 116-166 g/L or 12-17 d/dL)
Total white blood cell count – WBC (Ref. 3.5 –
9.0 x 109/L)
Absolute neutrophil count (Ref. >1.5 x 109/L or
- Value
1500/microL)
- Missing
Total trombocyte count, Blood – PTL (Rev. 150350 x 109 /L
Notes (e.g. other significant laboratory
abnormalities)
Weight (Kg)
Temperature (C) (Medical personal)
Note
Photos taken
Pictures with dates added to the
record
15
PHASE IV – UNSCHEDULED FOLLOWUP FOR ORAL PROBLEMS
From 6 weeks after Tx if:
1) the patient has ongoing oral
problems (out- or inpatient) <3 months
2) if the patient develops new oral
problems
Cause for present visit?
Current oral care regimens used by patient
PATIENT HISTORY
Specify main oral complaint
How does your mouth feel right now?
Do you have symptoms right now?
How difficult are the oral symptoms?
For how long have you had you problems?
Objectively (dentist) better/worse symptoms in
the oral cavity than at last visit?
(indicates if patient is deteriorating or healing)
Subjectively (patient) better/worse symptoms in
the oral cavity than at last visit?
EXAMINATION
WHO Mucositis Score
1) Extended Examination of ongoing oral problems close to Tx <3
months
2) Acute problems
Current oral care regimens used by
patient
Acute dental care; acute
examination; Biopsy; Excision;
Extraction; Focal Infection
Investigation; GVH; infection
investigation, check-up after SCT,
other research check up, Pain invest,
Sutures, Dental treatment,
investigation due to new or recurrent
haematologic malignancy, etc
Blisters
Bleeding
Bad taste
Taste changes
Filling fracture
Sensitive teeth
Burning sensation
Dry mouth
sand paper/raw feeling
Pain
Tenderness
Diffuse swelling
VAS 1-10
0 = none
10 = unbearable
Better, worse, completely healed,
unchanged (is this referring to
previous invasive dental
procedures?)
See above
Grade 0: No findings or erythema
16
(Please observe: It has to be because of
problems with the mouth)
OMAS Mucositis Score
Sonis et al Validation of a new scoring
system for the assessment of clinical
trial research of oral mucositis
induced by radiation or chemotherapy.
Cancer 1999 May 15;85(10):2103-13.
only
Grade 1: soreness present with or
without erythema
Grade 2: Ulcers present but able to
take solid food
Grade 3: Ulcers present and only
able to take liquids
Grade 4: Ulcers present/not able to
take anything orally
Ulceration/pseudomembrane
0 (no lesion)
1 (≤ 1 cm2)
2 (1-3 cm2)
3 (≥ 3 cm2)
Erythema
0 (None)
1 (not severe)
2 (severe)
Location
ORAL SYMPTOMS FORM
Location of mucosal/dental disease
Colour
Mucosal texture
See special form
Normal
Pale
Blue
Brown
Grey
Yellow
Dark
Red
White
Drop down list
Blister
Bleeding
Petecciae
Submucosal hemorrhage
Exostosis
Fissure
Fistula
Granuloma
Hyperplasia
Scalloping
Leukoedema
Necrosis
Pigmentation
Striae
Ulcer
Swollen
17
Tentative (preliminary) diagnosis
Diagnosis
Treatment type?
Diagnostic tests completed at today’s
appointment
GVHD Symptoms
If patients has GVHD symptoms, please feel in
the symptoms document.
Current medication
(NB! Don’t forget GVH-prophylaxis, Antiviral
prophylaxis, Antifungal prophylaxis)
To be filled in by medical personal if possible
Most recent lab test values
Blood-HGB (ref. 116-166 g/L or 12-17 d/dL)
Total white blood cell count – WBC (Ref. 3.5 –
9.0 x 109/L)
Absolute neutrophil count (Ref. >1.5 x 109/L or
1500/microL)
Total trombocyte count, Blood - PTL (Rev. 150350 x 109 /L
Recommend new drug treatment for oral
problems now? (by dentist or physician)
SYMPTOMS
Photos taken
Next visit
Note
Vescical
Scaring
Long list of dental/oral diagnoses
Tooth no
Long list of dental/oral diagnoses
Tooth number
Long list of dental/oral treatments
Tooth no
Treatment
Drop down list
Results
Bacterial
Viral
Fungal
Biopsy
Yes
No
acyclovir,
valacyclovir
CMV-prophylaxis
others (fill in)
fluconazole,
nystatin rinse,
amphotericin B local,
amphotericin B systemic
Cephalosporin
Bactrim
V-penicillin
?
Long list of medications (e.g.
fluconazole for fungal, acyclovir for
viral infection, morphine for oral
pain, antibiotics for oral bacterial
infection)
SEE SEPARATE SHEET
Pictures with dates added
18
PHASE V
3, 6, 12 months after transplant
Months after Tx
Current status of cancer
Current oral care regimens used by patient
List any symptoms from the oral cavity or
teeth today (current oral complaints)?
Describe any symptoms from the oral cavity or
teeth since last visit?
Have had any fungal infect. in oral mucosa
after Tx/since last oral check up here?
Have had any viral infect. in oral mucosa after
Tx/ since last oral check up here?
Have had any bact. infect. in oral mucosa after
Tx/ since last oral check up here?
ORAL SYMPTOMS FORM
GVHD SYMPTOMS FORM (for allogeneic
transplant patients only)
EXAMINATION
Mucosal disease/lesion
Location of mucosal disease
Colour
Mucosal texture
Drop down list of the number months
after Tx that the patient comes in
Drop down (remission; recurrence;
new primary cancer)
Drop down
None
No, yes, extraoral, intraoral?
No, intraoral, labial, CMV
Se separate form
Dropdown list:
Lichen planus,
geographic tongue,
leukoplakia from unknown cause,
lesion from smokeless tobacco,
pemphigoid,
aphthae,
other…
gingival hyperplasia
Viral infection
Fungal infection
Bacterial infection
GVH
Normal
Pale
Blue
Brown
Grey
Yellow
Dark
Red
White
Drop down list
Blister
Bleeding
Important
that it
allows
multiple
19
Have you had dental problems since last dental
visit?
Diagnostic tests taken
Have oral complications been identified as a
cause of additional hospital visits, prolonged
Petecciae
Submucosal hemorrhage
Exostosis
Fissure
Fistula
Granuloma
Hyperplasia
Scalloping
Leukoedema
Necrosis
Pigmentation
Striae
Ulcer
Swollen
Vescical
Scaring
Long list of dental diagnoses
Drop down list
Bacterial
Viral
Fungal
Biopsy
Yes
Results
No
If yes, which oral complication?
hospital stays or death?
How many visits? / How long were
the visits?
Most recent lab test values
Blood-HGB (ref. 116-166 g/L or 12-17 d/dL)
Total white blood cell count – WBC (Ref. 3.5
– 9.0 x 109/L)
Absolute neutrophil count (Ref. >1.5 x 109/L
or 1500/microL)
Total trombocyte count, Blood - PTL (Rev.
150-350 x 109 /L
Type of treatment for each dental problems?
?
Long list (include. treatm., referrals
etc)
Recommend new drug treatment for non-dental Long list of medications (e.g.
oral problems now? (by dentist or physician)
fluconazole for fungal, acyclovir for
viral infection, morphine for oral
pain, antibiotics for oral bacterial
infection)
Medication for dry mouth etc
Next appointment
20
Notes
Photos taken
PHASE VI
Patient deceased
Pictures with dates added
Days after transplantation
1) Measurements for poor clinical and economic outcomes; including days of
hospitalization for SCT will be discussed with dr Jan-Erik Johansson.