SS_B_Attachment_13-OS_Adjudicator_Forms

SS_B_Attachment_13-OS_Adjudicator_Forms.pdf

Women's Health Initiative Observational Study (NHLBI)

SS_B_Attachment_13-OS_Adjudicator_Forms

OMB: 0925-0414

⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0925-0414 can be found here:

Document [pdf]

Download: pdf | pdf

Supporting Statement B
Attachment 13
OS Adjudicator Forms

ADJUDICATOR FORMS

Report of Cardiovascular Outcome
Report of Fracture Outcome
Report of Death (Final)
Summary of Hospitalization Diagnosis
Report of Cancer Outcome
Report of Stroke Outcome

Form 121 - Report of Cardiovascular Outcome

Ver. 8.1
OMB# 0925-0414 Exp: 5/09

COMMENTS

-Affix label here-

Member ID: __ __

__ __ - ___ ___ ___ - __

To be completed by Physician Adjudicator
Date Completed:

Adjudicator Code:

(M/D/Y)

Central Case No.:
Case Copy No.:

(For items 1-8, each question specifies “mark one” or “mark all” that apply.)
Complete Q1 - ECG, Q2 - cardiac enzyme, and Q3 - cardiac pain information for the following WHI
Extension Study outcomes: Myocardial infarction (MI), coronary death [hospitalized], and coronary
revascularization
1. ECG pattern: (Mark the one category that applies best.)

1
2
3
8
9

Evolving Q-wave and evolving ST-T abnormalities
Equivocal Q-wave evolution; or evolving ST-T abnormalities; or new left bundle branch block
Q-waves or ST-T abnormalities suggestive of an MI and not classified as code 1 or 2 above
Other ECG pattern, ECG uncodable, or normal ECG pattern
ECG not available

2. Cardiac enzyme information available?

0
1

Skip to Question 3 on page 2.

Yes

2.1. Serum creatine kinase (CK): (Mark all that apply.) (Always record % or index if available.)
If CK-MB available:
CK-MB expressed as a % or index: (Record peak results only.)

1
2
3

CK-MB at least 2x upper limit of normal for % or index
CK-MB greater than upper limit of normal but less than 2x upper limit of normal for % or index
CK-MB within normal limits for % or index

CK-MB expressed in units (usually ng/ml): (Record peak results only.)

4
5
6

CK-MB at least 2x upper limit of normal for units
CK-MB greater than upper limit of normal but less than 2x upper limit of normal for units
CK-MB within normal limits for units

If CK-MB not available:

9 Total CK at least 2x upper limit of normal
10 Total CK greater than upper limit of normal but less than 2x upper limit of normal
11 Total CK within normal limits
99 CK result not available
R:\DOC\EXT\FORMS\ENG\CURR\F121V8_1 5/15/06

Pg. 1 of 5

WHI

Form 121 - Report of Cardiovascular Outcome

Ver. 8.1

2.2. Troponin lab test. (Mark the one category that applies best.) (If more than one test was
conducted, record the type with the most elevated lab result.)

1
2
3

4
9

Troponin C
Troponin I

Troponin, not specified
Troponin not available

Skip to Question 3 below.

Troponin T

2.2.1 Results (Mark the one category that applies best.) Troponin values should be coded using
the upper limit of normal (ULN) and not upper limit of indeterminate/indecisive as the reference
value. Thus, if 2 cutpoints are given, choose the lower cutpoint for the upper limit of normal.

1
2
3
9

Troponin at least 2x upper limit of normal
Troponin greater than upper limit of normal but less than 2x upper limit of normal
Troponin within normal limits
Other

3. Cardiac pain defined as: an acute episode of pain, discomfort or tightness in the chest, arm, throat or jaw:
(Mark the one category that applies best.)

1
2
9
Yes

Present
Absent
Unknown/Not recorded

No 4. Definite, probable, or aborted myocardial infarction (See excerpts from Table 8.5.1 – Definition of
Criteria for Diagnosis of Myocardial Infarction and Table 8.5.2 – Algorithm for Enzyme Diagnostic
0
Criteria on the last page of this form.)

4.1. Date of admission:

(M/D/Y)

4.2. Diagnosis: (Mark one.)

Myocardial infarction not occurring as a result of or during a procedure
Question 4.3 on the next page.

Myocardial infarction during or resulting from a procedure, i.e., within 30 days of any procedure.

Skip to

4.2.1. Type of Procedure (Mark one.)

1
2
3

A myocardial infarction that followed a cardiac procedure within 24 hours (for example,
diagnostic coronary catheterization, percutaneous coronary intervention, CABG,
pacemaker insertion, or cardioversion).
A myocardial infarction that followed a cardiac procedure within 2-30 days (for example,
diagnostic coronary catheterization, percutaneous coronary intervention, CABG,
pacemaker insertion, or cardioversion).
A myocardial infarction that followed a non-cardiac procedure within 30 days (for
example, any elective or emergency non-cardiac vascular procedure regardless of type
of anesthesia, or any elective or emergency surgical procedure requiring more than local
anesthesia).

R:\DOC\EXT\FORMS\ENG\CURR\F121V8_1 5/15/06

Pg. 2 of 5

WHI

Form 121 - Report of Cardiovascular Outcome

Ver. 8.1

4.3 Was a thrombolytic agent administered or emergent* revascularization procedure (e.g., angioplasty
or stent) performed? (Mark one.)
*An emergent revascularization is conducted within 12 hours of symptom onset; code both here
and in Q6. Non-emergent revascularization procedures are coded only under Q6. Examples
of thrombolytic agents are streptokinase, reteplase (Retavase), tenecteplase (TNKase),
alteplase tPA (Activase).

0
1
9

No
Yes
Unknown

4.4. Was the myocardial infarction fatal? (Mark one.)

0
1

No
Yes (Complete Question 5 below [for hospitalized deaths only] and Form 124 - Final
Report of Death.)

For hospitalized deaths only:
Yes

1 0

5. Coronary death (Complete Form 124 - Final Report of Death.)
5.1. Date of Death:

(M/D/Y)

5.2. Diagnosis:
Yes

1 0

6. Coronary revascularization
6.1. Date of Admission/Procedure:

(M/D/Y)

6.2. Type of procedure: Any one of the following procedures aimed at improving cardiac status
(Mark all that apply.)

1 Coronary artery bypass graft (CABG)
2 Percutaneous transluminal coronary angioplasty (PTCA), coronary stent, or coronary
atherectomy

6.3. Second myocardial infarction (MI) (i.e., second MI not already reported in Question 4) occurring as a
result of or during the revascularization procedure. (Mark one.)

0
1
2

No
Yes
Unknown

R:\DOC\EXT\FORMS\ENG\CURR\F121V8_1 5/15/06

Pg. 3 of 5

WHI
Yes

Form 121 - Report of Cardiovascular Outcome
No

1 0

Ver. 8.1

7. Carotid artery disease requiring and/or occurring during hospitalization. Disease must be
symptomatic and/or requiring intervention (i.e., vascular or surgical procedure).
7.1. Date of Admission:

(M/D/Y)

7.2. Diagnosis: (Mark one.)

1
2

Carotid artery occlusion and stenosis without documentation of cerebral infarction
Carotid artery occlusion and stenosis with documentation of cerebral infarction

7.3. Carotid artery disease based on (Hospitalization plus one or more of the following): (Mark all that
apply.)

1
2
3
Yes

1 0

Symptomatic disease with carotid artery disease listed on the hospital discharge summary
Symptomatic disease with abnormal findings (≥ 50% stenosis) on carotid angiogram, MRA, or
Doppler flow study
Vascular or surgical procedure to improve flow to the ipsilateral brain

8. Peripheral arterial disease (aorta, iliac arteries, or below) requiring and/or occurring during
hospitalization. Symptomatic disease including intermittent claudication, ischemic ulcers, or gangrene.
Disease must be symptomatic and/or requiring intervention (e.g., vascular or surgical procedure for
arterial insufficiency in the lower extremities or abdominal aortic aneurysm).
8.1. Date of Admission:

(M/D/Y)

8.2. Diagnosis: (Mark the one category that applies best.)

1
2
3
4

Lower extremity claudication
Atherosclerosis of arteries of the lower extremities
Arterial embolism and/or thrombosis of the lower extremities
Abdominal aortic aneurysm (AAA)

8.3. Peripheral arterial disease based on: Defined by hospitalization plus one or more of the following:
(Mark all that apply.)

Ultrasonographically- or angiographically-demonstrated obstruction, or ulcerated plaque (≥
50% of the diameter or ≥ 75% of the cross-sectional area) demonstrated on ultrasound or
angiogram of the iliac arteries or below

2
3
4
5
6

Absence of pulse by doppler in any major vessel of lower extremities

7
8

Exercise test that is positive for lower extremity claudication
Surgery, angioplasty, or thrombolysis for peripheral arterial disease
Amputation of one or more toes or part of the lower extremity because of ischemia or gangrene
Exertional leg pain relieved by rest and at least one of the following: (1) claudication diagnosed
by physician, or (2) ankle-arm systolic blood pressure ratio ≤ 0.8
Ultrasonographically- or angiographically-demonstrated abdominal aortic aneurysm
Surgical or vascular procedure for abdominal aortic aneurysm

________________________________________
Responsible Adjudicator Signature

R:\DOC\EXT\FORMS\ENG\CURR\F121V8_1 5/15/06

Pg. 4 of 5

WHI

Form 121 - Report of Cardiovascular Outcome

Ver. 8.1

Table 1
Definition of Criteria for Diagnosis of Myocardial Infarction
Cardiac Enzyme Interpretation
(see Table 8.8 below)
Abnormal

Equivocal

Incomplete

Normal

Definite MI

Probable MI

No MI

Q waves or ST-T abnormalities suggestive
of an MI and not classified above

Definite MI

Probable MI

No MI

Other ECG, ECG absent or uncodable

Definite MI

No MI

Definite MI

Probable MI

Definite MI

Probable MI

No MI

Probable MI

No MI

ECG Pattern/Symptoms
Cardiac pain present:
Evolving Q wave and evolving ST-T
abnormalities
Equivocal Q wave evolution; or evolving
ST-T abnormalities, or new left bundle
branch block

Cardiac Pain absent:
Evolving Q wave and evolving ST-T
abnormalities
Equivocal Q wave evolution; or evolving
ST-T abnormalities; or new left bundle
branch block
Q waves or ST-T abnormalities suggestive
of an MI and not classified above
Other ECG, ECG absent or uncodable

Table 2
Algorithm for Enzyme Diagnostic Criteria
Interpretation
Cardiac Enzyme
Creatine kinase MB
fraction (CK-MB)

Abnormal*

Equivocal

Normal

≥ 2x ULN (as %, index, or
units); or “present” without
quantification

1-2x ULN (as %, index, or
units); or “weakly present”

WNL

Troponin ≥ 2x ULN

Troponin 1-2x ULN

Troponin is WNL

N/A

Total CK ≥ 2x ULN

Total CK is 1-2x
ULN or WNL

Toponin (C, I, or T)**
Total creatine kinase
(CK) (no MB available)
ULN = upper limit of normal
WNL = within normal limits

* If both CK-MB and Troponin are available, Troponin must be elevated to be considered abnormal, if only CK-MB is
available, abnormal levels are enough to code enzymes as abnormal, i.e., WHI considers Troponin as the most accurate
indicator of myocardial injury.
** Code Troponin levels using the ULN and not Upper limit of undeterminate/indecisive as the reference value. Thus, if 2
cut points are given, choose the lower cut point for the ULN.

R:\DOC\EXT\FORMS\ENG\CURR\F121V8_1 5/15/06

Pg. 5 of 5

WHI

Form 123 - Report of Fracture Outcome

Ver. 8.1
OMB #0925-0414 Exp: 5/09

COMMENTS

-Affix label here-

Member ID: __ __

__ __ - ___ ___ ___ - __

To be completed by Physician Adjudicator:
Date Completed:

Adjudicator Code:

(M/D/Y)

Central Case No.:
Case Copy No.:

Use a separate form for each fracture.
Yes

1 0

1. Confirmed hip fracture: Fracture of the proximal femur, including fractures of the femoral neck,
intertrochanteric region, and greater trochanter
1.1.

Date of Diagnosis:

1.2.

Fracture site: (Mark the one that applies best.)

1
2

(M/D/Y)

Neck of femur (transcervical, cervical)
Intertrochanteric fracture

3
4

Greater trochanter
Unspecified part of proximal femur

1.3. Side of hip fracture: (Mark the one that applies best.)

1
2

3
9

Right
Left

Both sides
Unknown

1.4. Hip fracture based on: (Mark the one category that applies best.)

1
2
3

4
1.5.

Written radiology report that is read by a radiologist and identifies the presence of a
new, acute, or healing fracture of the proximal femur (femoral neck, intertrochanteric
region, or the greater trochanter region) and documented on a discharge summary
Radiologist's report confirms a proximal femur fracture, but the hospital discharge
summary does not (or is equivocal or missing)
All of the following:
1) hospital discharge summary listing fracture of the proximal femur, femoral neck
fracture, intertrochanteric fracture, trochanteric fracture, or hip fracture;
2) equivocal written radiology report of the hip (e.g., "possible" or "probably" or
"suspected" hip fracture); and,
3) a written radiologist's report of either a bone scan or MRI scan unequivocally
stating that a new hip fracture or healing hip fracture is present
Hip fracture diagnosed in discharge summary, or other written report, but no radiology
report available or radiograph not read by radiologist

Pathologic hip fracture: fracture resulting from bone tumors or cysts, Paget’s disease, bone or joint
prostheses, or surgical manipulation. Osteoporotic fracture is not considered a pathologic fracture.
(Mark the one category that applies best.)

1 Yes

Possible

Responsible Adjudicator Signature
RV_________K_________V_________
R:\DOC\EXT\FORMS\ENG\CURR\F123V8_1.DOC 5/15/06

Pg. 1 of 1

WHI

Form 124 - Report of Death (Final)

Ver. 8.1
OMB #0925-0414 Exp: 5/09

COMMENTS

- Affix label here-

Member ID: __ __

__ __ - ___ ___ ___ - __

To be completed by Physician Adjudicator
Date Completed:

Adjudicator Code:

1. Date of death:

(M/D/Y)

Central Case No.:
Case Copy No.:

(M/D/Y)
ICD-9-CM/ICD-10-CM Codes

2. Cause of death:
2.1.

CCC use
only

Underlying cause: (Disease or injury that initiated
events resulting in death.)
|

2.2.

2.3.

2.5.

2.6.

2.8.

2.9.

2.11.

2.12.

2.14.

2.15.

Contributory cause(s) of death. (Contributory causes
do not have to be listed in the hierarchical order.)
2.4.

2.10. |

2.7.

2.13. Immediate cause: (Final disease or condition resulting
in death.)
|

RV
R:\DOC\EXT\FORMS\ENG\CURR\F124V8_1.DOC 5/15/06

Pg. 1 of 3

WHI

Form 124 - Report of Death (Final)

Ver. 8.1

3. Subclassification of underlying cause of death:
(Select only one underlying cause from the following 4 categories (Cancer, CVD, Accident, Other). One
category must be completed.)
Cancer

1
2
3
4
5

Breast
Ovarian
Endometrial
Colon
Rectosigmoid junction

6 Rectum
7 Uterus
10 Lung
8 Other Cancer __________________________
9 Unknown cancer site

Cardiovascular disease

11 Definite Coronary Heart Disease (CHD)
(No known non-CHD cause and at least one of the following:
(1)-chest pain within 72 hours of death and/or (2)-history of
chronic ischemic heart disease in the absence of valvular heart
disease or non-CHD, and death certificate consistent with CHD
as the underlying cause.)

If box 11 or 14 marked, complete
Question 6 on the next page.

14 Possible Coronary Heart Disease (CHD)

(No known non-CHD cause, and death certificate consistent
with CHD as the underlying cause.)

12 Cerebrovascular disease
13 Pulmonary Embolism
18 Other cardiovascular disease
19 Unknown cardiovascular disease
Accident/Injury

21
22
23
28

Homicide
Accident
Suicide
Other injury

“Other” Cause of Death

31 Alzheimer’s Disease
32 COPD
33 Pneumonia
34 Pulmonary Fibrosis

35 Renal Failure
36 Sepsis
88 Another cause of death, known
99 Unknown cause of death

R:\DOC\EXT\FORMS\ENG\CURR\F124V8_1.DOC 5/15/06

Pg. 2 of 3

WHI

Form 124 - Report of Death (Final)

Ver. 8.1

4. Was an autopsy performed? (Mark one.)

0
1
9

No
Yes
Unknown

5. Documentation used for death adjudication (Mark all that apply):

Medical records documentation
(current case only)

2
3
4
5
6.

Report of autopsy findings
Death certificate
ER record

6 Informant interview
7 Form 120 – Initial Notification of Death
9 NDI Search (CCC use only)
10 Coroner’s report
8 Other ________________________________

EMS report

(e.g., a previously adjudicated case)

Coronary Death (In and out of hospital deaths)
6.1. Coronary death based on: (Mark all that apply.)
Hospitalized myocardial infarction within 28 days of death
1

Previous angina, myocardial infarction, or revascularization procedure and no known potentiallylethal non-coronary disease process

3
4

Coronary heart disease (CHD) diagnosed as cause of death at post-mortem examination

Death resulting from a CHD-related procedure, such as coronary bypass grafting (CABG) or
percutaneous transluminal coronary angioplasty (PTCA) [For any death resulting from a
revascularization procedure or an in hospital death, complete Form 121 – Report of
Cardiovascular Outcome]
Other (none of the above)

6.2. Coronary death subclassification: (Mark the one category that applies best.)
1 Definite fatal MI: no known non-atherosclerotic cause (and death within 28 days of definite MI) or
autopsy evidence of acute MI

2
3

Definite fatal CHD: no known non-atherosclerotic cause and at least one of the following:
(1) chest pain within 72 hours of death, or (2) history of chronic ischemic heart disease in the
absence of valvular heart disease or non-ischemic cardiomyopathy
Possible fatal CHD: no known non-atherosclerotic cause, and death certificate consistent with CHD
as the underlying cause

6.3. Timing of coronary death: (Mark one.)
1 Sudden death: death occurring within one hour of symptom onset or after the participant was last
seen without symptoms, and death occurs in the absence of potentially lethal non-coronary disease
process

2
3

Rapid death: death occurs within 1-24 hours of symptom onset
Other coronary death (Does not fulfill criteria for sudden or rapid coronary death.)

Responsible Adjudicator Signature
NOTE:

If this is a hospitalized death, or an autopsy report is available, adjudicate any WHI outcomes using the appropriate
outcomes form.

R:\DOC\EXT\FORMS\ENG\CURR\F124V8_1.DOC 5/15/06

Pg. 3 of 3

WHI

Form 130 – Report of Cancer Outcome

Ver. 8.2
OMB #0925-0414 Exp: 5/09

COMMENTS

- Affix label here-

Member ID: __ __ __ __ - ___ ___ ___ - __ #___

To be completed by CCC Cancer Coder:
Date Completed:

Adjudicator Code:

(MM/DD/YY)

Central Case No.:
Case Copy No.:

Use a separate form for each new diagnosis.
1. Date of Diagnosis:

(MM/DD/YY)

2. Primary cancer site: (Mark the one that applies best.)
Main WHI Cancer Outcomes

50
56
54
18
20
19

Questions 1–3, 5–14 required.

Breast
Ovary
Corpus uteri, endometrium
Colon (excludes appendix, see below)

Questions 1–3, 5–10 required.

Rectum
Rectosigmoid junction

Questions 1–6 required.

Other Cancer Outcomes

31 Accessory sinuses
74 Adrenal gland
21 Anus
86* Appendix
24 Biliary tract, parts of
[other/unspecified]

67
40

69
57

Eye and adnexa

64
32
42

Kidney

Bladder
Bones, joints & articular
cartilage of limbs

41 Bones, joints & articular
cartilage [other/unspecified]
71
72

Brain

53
49

Cervix

Endocrine glands & related
structures [other/unspecified]

Esophagus

Central Nervous System
(excludes brain)

Connective, subcutaneous &
other soft tissues

Genital organs, female
[other/unspecified]

Larynx

07
47

Parotid gland (Stensen's duct)

12
39

Pyriform sinus

Leukemia [hematopoietic &
reticuloendothelial systems
[includes blood; excludes multiple
myeloma]

Peripheral nerves & autonomic
nervous system

Respiratory system and
intrathoracic organs
[other/unspecified]

Salivary glands, major

22 Liver
34 Lung (bronchus)
77 Lymph nodes
83* Lymphoma, Hodgkin's disease
82* Lymphoma, non-Hodgkin's

16
73
02

Stomach

Urinary organs

44 Melanoma of the skin
85* Multiple myeloma
06 Oral (mouth) [other/unspecified]
05 Palate
25 Pancreas

Uterus, not otherwise
specified

Other (Specify site. Enter
site code in Qx. 3.)

disease

R:\DOC\EXT\FORMS\ENG\CURR\F130V8_2.DOC 7/15/06

1 of 4

[other/unspecified]

Thyroid
Tongue, part of
[other/unspecified]
[other/unspecified]

WHI

Form 130 – Report of Cancer Outcome

Ver. 8.2

3. ICD-0-2 Code: Complete for Main Cancer site or “Other Cancer” site not already specified
in Question 2. (Note to ancillary study coder, complete as requested by CCC.)

.
4. Tumor Behavior: Complete only for an “Other Cancer” diagnosis. (Mark one only.)

1
2
3

Invasive; malignant; infiltrating; micro-invasive
In situ; intraepithelial; non-infiltrating; non-invasive; intraductal
Borderline malignancy; low malignant potential; uncertain whether benign or malignant;
indeterminate malignancy

9 Unknown
5. Reporting Source: (Mark one only. If more than one category applies, mark the first applicable
category.)

1
2
3
4
5
6
7

Hospital inpatient
Hospital outpatient/radiation or chemotherapy facility, surgical center, or clinic
Laboratory only (hospital or private) including pathology office
Physician's office/private medical practitioner
Nursing/convalescent home/hospice
Autopsy only
Death certificate only

6. Diagnostic Confirmation Status: (Mark one only. If more than one category applies, mark the first applicable
category.)
Microscopically Confirmed:

1 Positive histology (pathology)
2 Positive exfoliative cytology, no positive histology
3 Positive histology (pathology), regional or distant metastatic site only
4 Positive microscopic confirmation, method not specified
Not Microscopically Confirmed:

5 Positive laboratory test/marker study
6 Direct visualization without microscopic confirmation
7 Radiography and other imaging techniques without microscopic confirmation
8 Clinical diagnosis only (other than 5, 6 or 7 above)
Confirmation Unknown:

Unknown if microscopically confirmed

R:\DOC\EXT\FORMS\ENG\CURR\F130V8_2.DOC 7/15/06

2 of 4

WHI

Form 130 – Report of Cancer Outcome

Complete Questions 7–10 for Main Cancer Outcomes only.
7. Laterality: (Mark one only.)
Not a paired site
Right: origin of primary
Left: origin of primary
Only one side involved, right or left origin unspecified
Bilateral involvement, lateral origin unknown: stated to be single primary

10. Summary Stage (SEER): (Mark one only.)

1
2
3
4
9

In situ
Localized
Regional
Distant
Unknown

R:\DOC\EXT\FORMS\ENG\CURR\F130V8_2.DOC 7/15/06

3 of 4

9.
5

9.
4

8.
3

9.
3

8.
2

9. EOD (SEER):

9.
2

8. Morphology:

8.
1

Paired site, but no information concerning laterality; midline tumor

9.
1

0
1
2
3
4
5

Ver. 8.2

WHI

Form 130 – Report of Cancer Outcome

Ver. 8.2

Complete Questions 11–14 for Breast Cancer Only.
11. Complete the subclassification for Breast Histology 8522: (Mark one only.)

0
1
2

Ductal in situ plus lobular in situ
Ductal invasive plus lobular in situ

12. Estrogen Receptor Assay:
(Mark one only.)

1
2
3
8
9

Positive

Invasive cancer, ductal and lobular nos

12.1. Date:
(MM/DD/YY)

12.2. Type of assay:
(Mark one only.)

13.1. Date:

13.2. Type of assay:
(Mark one only.)

Ordered/Results not available

1 fmol/mg protein
2 ICC/IHC
8 Other:
9 Unknown

Unknown/Not done

(MM/DD/YY)

Positive
Negative
Borderline
Ordered/Results not available
Unknown/Not done

14.1. Date:

(Mark one only.)
Positive

(MM/DD/YY)

Negative
Borderline
Ordered/Results not available
Unknown/Not done

___________________________________________
Coder Signature

15.

Lobular invasive plus ductal in situ

Borderline

14. Her 2/Neu:

1
2
3
8
9

Ductal invasive plus lobular invasive

Negative

13. Progesterone Receptor Assay:
(Mark one only.)

1
2
3
8
9

3
4
5

Not applicable

Editor Code:

R:\DOC\EXT\FORMS\ENG\CURR\F130V8_2.DOC 7/15/06

4 of 4

1
2
8
9

fmol/mg protein
ICC/IHC
Other:
Unknown

WHI

Form 132 - Report of Stroke Outcome

Ver. 8.2
OMB #0925-0414 Exp: 5/09

COMMENTS

-Affix label hereMember ID: __ __ __ __ - ___ ___ ___ - __

To be completed by Physician Adjudicator:
Date Completed:

Adjudicator Code:

Yes

1 0

(M/D/Y)

Central Case No.:
Case Copy No.:

Stroke: Rapid onset of a persistent neurologic deficit attributable to an obstruction or rupture of the
arterial system (including stroke occurring during or resulting from a procedure).* Deficit is not known
to be secondary to brain trauma, tumor, infection, or other cause. Deficit must last more than 24 hours,
unless death supervenes or there is a demonstrable lesion compatible with acute stroke on CT or MRI
scan.
*A stroke is defined as procedure-related if it occurs within 24 hours after any procedure or within 30
days after a cardioversion or invasive cardiovascular procedure.

1.1.

Date of Admission or diagnosis:

1.2.

Diagnosis: (Mark the one category that applies best.)

(M/D/Y)

Hemorrhagic Stroke

1
2
3

Subarachnoid hemorrhage
Intraparenchymal hemorrhage
Other or unspecified intracranial hemorrhage (e.g., isolated intraventricular hemorrhage)
Ischemic Stroke (If selected, complete questions 1.5 – Oxfordshire and 1.6 - TOAST
Classification on the next page.)

Occlusion of cerebral or pre-cerebral arteries with infarction (cerebral thrombosis, cerebral
embolism, lacunar infarction)
Other

5
1.3.

Stroke occurred during or resulted from a procedure (defined above*). (Mark one.)

0
1
9
1.4.

Acute, but ill-defined, cerebrovascular disease (select this option only if unable to code as
hemorrhagic or ischemic)

No
Yes
Unknown

Was the stroke diagnosed or managed as an outpatient?*

0
1

No
Yes

*The outpatient setting includes any emergency department or observation unit, short hospital stays of
less than 24 hours duration or a direct admission to a rehab facility without an associated admission to
an acute care hospital.
RV_________K_________V_________
R:\DOC\EXT\FORMS\ENG\CURR\F132V8_2.DOC 10/30/08

Pg. 1 of 3

WHI

Form 132 - Report of Stroke Outcome

Ver. 8.2
OMB #0925-0414 Exp: 5/09

1.5.

Oxfordshire Classification (Mark the one category that applies best.)

1
2
3
4
1.6.

Total anterior circulation infarct (TACI)
Partial anterior circulation infarct (PACI)
Lacunar infarction (LACI)
Posterior circulation infarct (POCI)

Trial of Org 10172 in Acute Stroke Treatment (TOAST) Classification
(Mark the one category that applies best.)
Probable

Possible

Large artery atherosclerosis
(embolus/thrombosis)

Cardioembolism (high-risk/medium risk)

2
3
4

6
7
10

Small vessel occlusion (lacune)
Stroke of other determined etiology
Stroke of undetermined etiology
Two or more causes identified
Negative evaluation
Incomplete evaluation

1.7

11
12
13

Stroke diagnosis based on: (Mark the one category that applies best.)

Rapid onset of neurological deficit and CT or MRI scan shows acute focal brain lesion consistent
with neurological deficit and without evidence of blood (except mottled cerebral pattern)

Rapid onset of localizing neurological deficit with duration ≥ 24 hours but imaging studies are not
available

3
4
5

Rapid onset of neurological deficit with duration ≥ 24 hours and the only available CT or MRI scan
was done early and shows no acute lesion consistent with the neurologic deficit
Surgical evidence of ischemic infarction of brain
CT or MRI findings of blood in subarachnoid space, intra-parenchymal, or intraventricular
hemorrhage consistent with neurological signs or symptoms

6
7

Positive lumbar puncture (for subarachnoid hemorrhage)
Surgical evidence of subarachnoid or intra-parenchymal hemorrhage as the cause of a clinical
syndrome consistent with stroke

None of the above (e.g., fatal strokes where no imaging studies or clinical evidence are available;
or CT/MRI does not show lesion consistent with the neurologic deficit)

R:\DOC\EXT\FORMS\ENG\CURR\F132V8_2.DOC 10/30/08

Pg. 2 of 3

WHI

Form 132 - Report of Stroke Outcome

Ver. 8.2
OMB #0925-0414 Exp: 5/09

1.8.

If stroke fatal: (Mark all that apply.)

1
2
3
4
1.9

Hospitalized stroke within 28 days of death
Previous stroke and no known potentially lethal non-cerebrovascular disease process
Stroke diagnosed as cause of death at post-mortem examination
Stroke listed as underlying cause of death on death certificate

Participant’s functional status at the time of discharge* (Glasgow Outcome Scale):
(Mark the one category that applies best.)
*Participant may be discharged from the Emergency Department, hospital, or physician’s office.

1
2
3
4
5
6

Good recovery – Patient can lead a full and independent life with or without minimal neurological
deficit
Moderately disabled – Patient has neurological or intellectual impairment but is independent
Severely disabled – Patient conscious but dependent on others to get through daily activities
Vegetative survival – Has no obvious cortical functioning
Dead
Unable to categorize stroke based on available case packet documentation (for limited use only
when adjudicator is unable to categorize above).

Yes

Transient ischemic attack: One or more episodes of a focal neurologic deficit lasting more than 30
seconds and no longer than 24 hours. Rapid evolution of the symptoms to the maximal deficit in less
than 5 minutes, with subsequent complete resolution. No head trauma occurring immediately before
the onset of the neurological event.

2.1.

Date of Admission or diagnosis:

Carotid artery disease requiring and/or occurring during hospitalization. Disease must be
symptomatic and/or requiring intervention (i.e., vascular or surgical procedure).

3.1.

Date of Admission:

3.2.

Diagnosis: (Mark one.)

1 0

Yes

1 0

1
2
3.3.

(M/D/Y)

Carotid artery occlusion and stenosis without documentation of cerebral infarction
Carotid artery occlusion and stenosis with written documentation of cerebral infarction

Carotid artery disease based on (Hospitalization plus one or more of the following):
(Mark all that apply.)

1
2

Symptomatic disease with carotid artery disease listed on the hospital discharge summary
Symptomatic disease with abnormal findings (≥ 50% stenosis) on carotid angiogram, MRA, or
Doppler flow study

Vascular or surgical procedure to improve flow to the ipsilateral brain

Responsible Adjudicator Signature
R:\DOC\EXT\FORMS\ENG\CURR\F132V8_2.DOC 10/30/08

Pg. 3 of 3

File Type	application/pdf
Author	Administrator
File Modified	2009-03-04
File Created	2008-12-09