SS_B_Attachment_14-OS_Adjudicator_Form_Instructions

Supporting Statement B
Attachment 14
OS Adjudicator Form
Instructions

ADJUDICATOR FORMS
INSTRUCTIONS

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

WHI Extension – Appendix B, Form 121 - Report of Cardiovascular Outcome (Ver. 8)

Page 1

FORM:

121 - REPORT OF CARDIOVASCULAR OUTCOME

Version:

8 – October 1, 2005

Description:

5-page form filled out by the Physician Adjudicator after the diagnosis of one or more
cardiovascular outcomes. Key-entered at the CCC, as appropriate.

When used:

Completed when the Physician Adjudicator confirms that a WHI Extension Study participant
(Clinical Trial [CT] or Observational Study [OS]) has experienced a WHI Extension Studydefined cardiovascular outcome requiring a hospitalization. The form must also be completed to
confirm an outpatient PTCA/revascularization procedure.

Purpose:

To provide confirmation of a WHI Extension Study cardiovascular outcome.

GENERAL INSTRUCTIONS

1.

A Physician Adjudicator must complete this form when a participant is confirmed as having had one or more of the
WHI Extension Study cardiovascular outcomes listed below:
•

Definite or probable myocardial infarction

•

Coronary death

•

Coronary revascularization (including outpatient coronary revascularization)

•

Carotid artery disease requiring hospitalization

•

Peripheral arterial disease requiring hospitalization

2.

Obtain all available required documentation before filling out the form. (See Table 8.2.2 - Documentation
Requirements for WHI Extension Study Outcomes.)

3.

CCC Outcomes staf will place the participant's barcode label in the space provided at the top of the form and route
the form and a copy of the supporting medical record documents to the Physician Adjudicator for completion and
signature.

4.

Record ECG and cardiac enzyme criteria for any confirmed MI, coronary death, or coronary revascularization
procedure.

5.

When the Physician Adjudicator returns the completed form, the CCC Outcomes staff will review the form for
completeness and discuss any questions with the Physician Adjudicator. Send to data entry for key-entry.

6.

Data Entry: Key-enter the form and initial the first page of the form after key-entry.

7.

File a copy of the adjudication case packet [outcomes form(s)] and a copy of all documentation used in the
adjudication] in the participant’s outcome file at the CCC.

8.

For additional details on adjudicating cardiovascular outcomes, refer to Section 8.5 - Outcomes Classification:
Cardiovascular Outcomes.

R:\DOC\EXT\FORMS\ENG\CURR\INST\I121V8.DOC 10/01/05

WHI Extension – Appendix B, Form 121 - Report of Cardiovascular Outcome (Ver. 8)

Page 2

Item Instructions

1.

Date completed

Month, day, year. Date that the form is completed by the Physician Adjudicator.

Adjudicator code

The 5-digit WHI Extension Study ID code for the Physician Adjudicator.

Adjudication case

The adjudication case number assigned in the WHIX database.

ECG pattern

Mark the one category that best describes the serial evolution of ECG pattern based
on as many of the following ECG records as are available. Note that enzymes are
to be coded for the timing of the event or symptoms, not just if collected for routine
monitoring. Box 1 and box 2 require serial ECGs.
Complete ECG information for a confirmed MI, coronary death, and
coronary revascularizations.
Left bundle branch block (LBBB): select box 2 - “equivocal Q-wave evolution;
or evolving ST-T abnormalities; or new LBBB” if there is documentation in the
medical record indicating the LBBB is new. Otherwise, select box 8-"Other ECG
pattern or ECG uncodable.”

2.

Cardiac Enzyme
information?

Yes/No. If the cardiac enzyme information is not available anywhere in the
medical records, select box - 0 “No”, and skip to question 3 – “Myocardial
Infarction (MI).”

2.1

Serum creatine kinase

If MB is available, do not classify total CK. For options referring to “normal
limits,” use the limits specified by the laboratory that conducted the test. If creatine
kinase was not measured or if no result is available, mark box – 99 "CK result not
available."
Data Entry: Key-enter each box checked.

2.2

Troponin
Lab Test

Mark the one category that applies best. Indicate Troponin C, I, T, or Troponin not
specified. If more than one Troponin test was conducted, indicate the type that was
most elevated.

2.2.1

Troponin
Lab Results

Mark the one category that applies best. If more than one Troponin test was
conducted, record the levels for the type that was most elevated. For the option
referring to “normal limits,” use the limit specified by the hospital laboratory that
conducted the test. Troponin values should be coded using the upper limit of
normal (UNL) and not the upper limit of indeterminate/indecisive as the reference
values. Thus, if 2 cutpoints are given, choose the lower cutpoint of the upper limit
of normal. If Troponin was not measured or if no result is available, mark
“Troponin not available” and skip to Question 3 - “Other cardiac-specific lab test.”

3.

Cardiac pain

Present/Absent/Unknown. Refers to an acute episode of pain, discomfort or
tightness in the chest, arm, throat, or jaw.

4.

Definite, probable, or
aborted MI

Yes/No. Using Table 8.5.1 – Definition of Criteria for Diagnosis of Myocardial
Infarction, mark the appropriate box and complete Questions 4.1. to 4.4.

4.1.

Date of admission

The admit date on the hospital medical records.

R:\DOC\EXT\FORMS\ENG\CURR\INST\I121V8.DOC 10/01/05

WHI Extension – Appendix B, Form 121 - Report of Cardiovascular Outcome (Ver. 8)

Page 3

4.2.

Diagnosis

Mark the one category that corresponds best to the Physician Adjudicator's final
diagnosis. If the myocardial infarction occurred during or resulted from a
procedure, mark the appropriate box listed under 4.2.1.

4.2.1.

Type of procedure

Mark the one category that applies best:
1. A MI that followed a cardiac procedure within 24 hours.
2. A MI that followed a cardiac procedure within 2-30 days.
3. A MI that followed a non-cardiac procedure within 30 days.

4.3.

Thrombolytic agent or
procedure

No/Yes/Unknown. Mark one. If “No”, skip to Question 3.5 – “Was the MI fatal.”
Mark "Yes" if medical record shows administration of streptokinase, reteplase
(Retavase), tenecteplase (TNKase), alteplase tPA (Activase); or a procedure (e.g.,
angioplasty) conducted soon after admission.

4.4.

MI fatal

No/Yes. Complete Question 5 – “Coronary Death.”

5.

Coronary death
[hospitalized deaths
only]

Yes/No.

5.1.

Date of death

The discharge date on the hospital medical records or the date on the death
certificate.

5.2.

Diagnosis

State the type of coronary death in words, e.g., definite CHD death, possible CHD
death, fatal MI, fatal CABG.

Note that Q.1 - ECG and Q.2 - enzyme information must be completed. Complete
Form 124 – Report of Death (Final) also.

Data Entry: Do not key-enter this text.
6.

Coronary
revascularization
(hospitalized/nonhospitalized)

Yes/No. Mark the appropriate box and complete Questions 6.1 to 6.2 to confirm
the procedure to improve the patency of one or more coronary arteries. Note that
Q.1 - ECG and Q.2 - enzyme information must be completed.

6.1.

Date of admission

Use the date of admission as the date of procedure, even if more than one
procedure was done.

6.2.

Type of procedure

Mark all that apply. If multiple procedures of the same type (e.g., two PTCA’s) are
conducted during a single hospital admission, only record the first procedure.

6.3

Second MI

Mark one. Mark only if a second MI not already reported in Question 4 –
“Definite, probable or aborted MI” occurred at this admission as a result of, or
during the coronary revascularization procedure.
Answer ‘No’ if enzymes were drawn after the revascularization and there is no
evidence for an MI.
Answer ‘Yes’ if enzymes were drawn after the revascularization and there was
evidence for an MI.
Answer ‘Unknown’ if no enzymes were drawn after the procedure.

7.

Carotid artery disease
requiring hospitalization

Yes/No. Mark the appropriate box and complete Questions 7.1 to 7.3 to confirm
the carotid artery disease. Note that participant must be hospitalized (and
symptomatic or requiring intervention).

R:\DOC\EXT\FORMS\ENG\CURR\INST\I121V8.DOC 10/01/05

WHI Extension – Appendix B, Form 121 - Report of Cardiovascular Outcome (Ver. 8)

Page 4

7.1.

Date of admission

The admit date on the medical records.

7.2.

Diagnosis

Mark the one box that corresponds best to the Physician Adjudicator's final
diagnosis.

7.3.

Criteria for diagnosing
carotid artery disease

Mark all that apply. Note that participant must be hospitalized (and symptomatic or
requiring intervention).

8.

Peripheral arterial
disease requiring
hospitalization

Yes/No. Mark the appropriate box and complete Questions 8.1 to 8.3 to confirm
the peripheral arterial disease. This diagnosis refers to disease in aorta, iliac
arteries or below that is symptomatic and/or requiring intervention; and requires or
occurs during a hospitalization. Includes abdominal aortic aneurysm but exludes
aortic dissection.

8.1.

Date of admission

The admit date on the hospital medical records.

8.2.

Diagnosis

Mark the one box that corresponds to the Physician Adjudicator's final diagnosis.

8.3.

Criteria for diagnosing
peripheral arterial
disease

Mark all that apply.

Responsible Adjudicator
Signature

The Physician Adjudicator should sign the form only when (s)he is satisfied that
the questions on the cardiovascular outcomes being reported have been filled in as
completely and accurately as possible on the basis of all available information, and
that other WHI Extension Study outcomes (e.g., hospitalization) have been
investigated and adjudicated.

R:\DOC\EXT\FORMS\ENG\CURR\INST\I121V8.DOC 10/01/05

WHI Extension – Appendix B, Form 123 - Report of Fracture Outcome (Ver. 8)

Page 1

FORM:

123 - REPORT OF FRACTURE OUTCOME

Version:

8 – October 1, 2005

Description:

2-page form filled out by UCSF Bone Density Center Physician Adjudicator. Key-entered at the
CCC.

When used:

Completed as the UCSF Bone Density Center Physician Adjudicator confirms that a WHI
Extension Study participant (Clinical Trial [CT] or Observational Study [OS]) has experienced a
WHI Extension Study-defined hip fracture outcome.

Purpose:

To provide confirmation of a hip fracture outcome.

GENERAL INSTRUCTIONS

1.

This form must be completed by a UCSF Physician Adjudicator only when a participant (in the CT or OS) is
confirmed as having had a WHI Extension Study-defined hip fracture.

2.

Obtain all available supporting documentation before filling out the form. (See Table 8.2.2 – Documentation
Requirements for WHI Extension Study Outcomes.)

3.

The CCC Outcomes staff will place the participant's barcode label in the space provided at the top of the form and
route the form and a copy of the supporting medical record documents to Physician Adjudicator for completion and
signature.

4.

Complete Question 1, items 1.1. - 1.5. for a confirmed hip fracture.

5.

When the completed form is returned by Physician Adjudicator, the CCC Outcomes staff will review the form for
completeness and discuss any questions with the Physician Adjudicator. Send to data entry for key-entry.

6.

Data Entry: Key-enter the form and initial the first page of the form after key-entry.

7.

File a copy of the adjudication case packet (form and a copy of all supporting documentation used in the
adjudication) in the participant's outcomes file at the CCC.

8.

For additional details on adjudicating a hip fractures outcome, refer to Section 8.6 - Outcomes Classifications: Hip
Fractures.

R:\DOC\EXT\FORMS\ENG\CURR\INST\I123V8.DOC 10/01/05

WHI Extension – Appendix B, Form 123 - Report of Fracture Outcome (Ver. 8)

Page 2

Item Instructions
Date completed

Month, day, year. Date that the form is completed.

Adjudicator code

The 5-digit WHI Extension Study employee ID for the Physician Adjudicator.

Adjudication case no.

The adjudication case number assigned in the WHIX database.

1.

Hip fracture

Yes/No. Mark the appropriate box and complete items 1.1. to 1.5. for a report
of a confirmed hip fracture.

1.1.

Date of diagnosis

Month, day, year. The date of hospital admission for radiologic confirmation of
the hip fracture or the date of radiologic confirmation if no hospitalization
occurred.

1.2.

Fracture site

Mark the one category that best describes the hip fracture site.

1.3.

Side of hip fracture

Mark one.

1.4.

Criteria used for diagnosis

Mark one. The items are arranged in hierarchical order from the strongest to
the weakest evidence of hip fracture, so mark the first item that applies.

1.5.

Pathologic fracture

Mark one.
Choose "No" if the fracture occurred as a result of trauma sufficient to cause a
fracture in normal healthy bone (e.g., a fall from a height or a motor vehicle
accident) and no underlying bone abnormality was noted.
Choose "Yes" if the fracture was associated with a documented underlying bone
abnormality including a bone tumor, bone cyst, Paget's disease (of bone),
cancer metastasis, or occurred at a pre-existing hip replacement site.
Choose "Possible" if the incident leading to the fracture does not seem
sufficient to cause a fracture in normal healthy bone, but there is no
unequivocal evidence of an underlying bone abnormality.

Responsible adjudicator
signature

The Physician Adjudicator should sign the form only when (s)he is satisfied
that the relevant items have been filled in as completely and accurately as
possible on the basis of the information available.

R:\DOC\EXT\FORMS\ENG\CURR\INST\I123V8.DOC 10/01/05

WHI Extension – Appendix B, Form 124 - Report of Death (Final) (Ver. 8)

Page 1

FORM:

124 - REPORT OF DEATH (Final)

Version:

8 – October 1, 2005

Description:

3-page form filled out by the Physician Adjudicator after a participant death. Key-entered at the
CCC.

When used:

Completed as the Physician Adjudicator confirms that a WHI Extension Study participant (CT or
OS) has died and her cause of death is determined.

Purpose:

To provide confirmation of a death and/or cause of death information.

GENERAL INSTRUCTIONS
1.

This form must be completed by a Physician Adjudicator when a participant has died.

2.

Obtain all available supporting documentation before filling out the form.

3.

The CCC Outcomes staff will place the participant’s barcode label in the space provided at the top of the form and
route the appropriate outcome form and a copy of the supporting documents to the Physician Adjudicator for
completion and signature.

4.

When the completed form is returned by the Physician Adjudicator, the CCC Outcomes staff will review the form
for completeness and discuss any questions with the Physician Adjudicator. Send to data entry for key-entry.

5.

File a copy of the form and a copy of all supporting documentation in the participant’s outcome file at the CCC.

6.

For additional details on adjudicating deaths, refer to Section 8.7 - Fatal Events.

R:\DOC\EXT\FORMS\ENG\CURR\INST\I124V8.DOC 10/01/05

WHI Extension – Appendix B, Form 124 - Report of Death (Final) (Ver. 8)

Page 2

Item Instructions
Date complete

Month, day, year. Date that the form is completed by the Physician Adjudicator.

Adjudicator code

The 5-digit WHI Extension Study ID for the Physician Adjudicator.

Adjudication case

The adjudication case number assigned in the WHIX database.

1.

Date of death

Month, day, year. The date of hospital discharge or the date on the death certificate.

2.

Cause of death

2.1.

Underlying cause

The underlying cause is the disease or injury that initiated events resulting in death.
Include the precise diagnosis in words.

2.2.

Underlying cause
ICD-9-CM or
ICD-10-CM code

The ICD-9-CM or ICD-10-CM code corresponding to the underlying cause of death as
documented in the medical records.

Contributory cause(s)
of death

Under 2.3.1, 2.3.3, and 2.3.5, indicate the events that contributed to the death but did
not directly cause the death. List only the top three. Hierarchical order not required.

2.3.

If the underlying cause of death is the result of an accident/injury and the
corresponding ICD-9-E-code or ICD-10-E-code is available, record the E-code in
Question 3 - Subclassification of underlying cause of death, Accident/Injury.

Under 2.3.2, 2.3.4, 2.3.6, indicate the ICD-9-CM or ICD-10-CM code corresponding
to the contributory cause of death.
If the immediate cause of death is the result of an accident/injury and the
corresponding ICD-9-E-code or ICD-10-E-code is available, record the E-code in
Question 3 - Subclassification of underlying cause of death, Accident/Injury.
2.4.

Immediate cause

The immediate cause is the final disease or condition resulting in death. Include the
precise diagnosis in words.

2.5.

Immediate cause
ICD-9-CM or
ICD-10-CM code

The ICD-9-CM or ICD-10-CM code corresponding to the immediate cause of death as
documented in the medical records. If the immediate cause of death is the result of an
accident/injury and the corresponding ICD-9-E-code or ICD-10-E-code is available,
record the E-code in Question 3 - Subclassification of underlying cause of death,
Accident/Injury.

3.

Subclassification of
underlying cause of
death
(Required)

Mark one. Subclassification of death includes cancer, cardiovascular disease,
accident/injury, other/known, and other/unknown.
If the subcategory of accident/injury is selected, record the appropriate E-Code listed
on the hospital face sheet or physician attestation and enter the E-Code into the WHIX
database. Only report a code with the prefix “E” (the external cause of injury and
poisoning). E-codes are used for classifying environmental events, circumstances, and
conditions as the cause of injury, poisoning, and other adverse effects.
Note: Identification of a death outcome (in the WHIX database) requires this
question to be completed.

4.

Autopsy

Mark one. No/Yes/Unknown

R:\DOC\EXT\FORMS\ENG\CURR\INST\I124V8.DOC 10/01/05

WHI Extension – Appendix B, Form 124 - Report of Death (Final) (Ver. 8)

Page 3

5.

Documentation
available for
adjudication

Mark all that apply. Record all documentation present in case packet used to
adjudicate the death. Sources include medical records, autopsy findings, death
certificate, ER record, EMS report, informant interview, Form 120 – Initial
Notification of Death, and Coroner’s report. NDI search option is for CCC use only.

6.

Coronary Death

Cause(s), subclassification and timing of coronary death. Complete for both in or out
of hospital coronary death. For all in-hospital coronary deaths, complete Form 121 –
Report of Cardiovascular Outcome.

6.1.

Criteria for
diagnosing coronary
death

Mark all that apply. Classification for which the coronary death is based.

6.2.

Coronary death
subclassification

Mark the one category that applies best. Definite fatal MI/definite fatal CHD/possible
fatal CHD.

6.3.

Timing of coronary
death

Mark one. If the timing of the coronary death is unknown, or the participant “drops
dead”, select Box 3 – Other coronary death.

Responsible
adjudicator signature

The Physician Adjudicator should sign the form only when (s)he is satisfied that the
relevant items have been filled in as completely and accurately as possible, on the
basis of the information available.

R:\DOC\EXT\FORMS\ENG\CURR\INST\I124V8.DOC 10/01/05

WHI Extension – Appendix A, Form 130 - Report of Cancer Outcome (Ver. 8.2)

Page 1

FORM:

130 - REPORT OF CANCER OUTCOME

Version:

8.2 – October 30, 2008

Description:

4-page form filled out by the CCC Cancer Coder after the diagnosis of a new cancer or
hematoproliferative or lymphoproliferative malignancy. Do NOT complete the form if the cancer
is a relapse, recurrence, or metastatic site of a cancer first diagnosed prior to entry into the study
or a cancer reported previously. Key-entered at CCC.

When used:

Completed when the Cancer Coder confirms that a WHI Extension Study participant (Clinical
Trial [CT] or Observational Study [OS]) has had a cancer diagnosed (excluding non-melanoma
skin cancer).

Purpose:

To provide confirmation of each newly-diagnosed (incident) cancer outcome.

The CCC Outcomes staff places the participant’s barcode ID label in the space provided at the top of the form and routes
the Form 130 and a copy of the supporting documents to the Cancer Adjudicator.

GENERAL INSTRUCTIONS

1.

This form must be completed by a CCC Cancer Coder when a WHI Extension Study participant (in the CT or OS)
is confirmed as having had a newly-diagnosed cancer or malignancy (excluding non-melanoma skin cancer).

2.

Only complete this form for newly-diagnosed primary cancers.

3.

Obtain all available supporting documentation before filling out the form.

4.

Use a separate form for each primary cancer site.

5.

The CCC Outcomes Staff will place the participant’s barcode label with ID number on the front page of the form
and route the form and a copy of the supporting documents to the CCC Cancer Coder for completion and signature.

6.

When the completed form is returned by the Cancer Coder, the CCC Outcomes Staff will review the form for
completeness and discuss any data questions with the Cancer Coder. Send to data entry for key-entry.

7.

Data Entry: Key-enter the form and initial the first page of the form after key-entry.

8.

File a copy of the adjudication case packet (form and a copy of all supporting documentation) in the participant’s
outcome file at the CCC.

9.

For additional details on adjudicating cancer outcomes, refer to Vol. 8, Section 4 - Outcome Classifications: Cancer
Outcomes.

R:\DOC\EXT\FORMS\ENG\CURR\INST\I130V8.2.DOC 10/30/08

WHI Extension – Appendix A, Form 130 - Report of Cancer Outcome (Ver. 8.2)

Page 2

Item Instructions

1.

Date completed

Month, day, year. Date the Cancer Adjudicator completed the form

Adjudicator code

3-digit ID for the Cancer Adjudicator.

Center Case No.

Case number assigned by WHIX.

Case Copy No.:

Copy number assigned by WHIX

Date of Ddiagnosis

Date of diagnosis is a required field and must be completed. Record the date of
the first tissue diagnosis for a new cancer. Generally, the first tissue diagnosis
will be when the initial biopsy of the cancer is done. If no tissue was obtained
to make the diagnosis, use the date of the first cytology diagnosis.
Tips for Date of Diagnosis:
• Oftentimes for leukemia cases, the first diagnosis may be made with a
peripheral blood smear.
• Do not code ’99 – Unknown’ for day, month, or year of diagnosis.
Currently, July is used as the default month and the 15th as the default
day. If the year of diagnosis is unknown, use the best approximation.

2.

Primary Cancer Site

Mark one primary cancer site. If a case has multiple cancer sites, complete a
Form 130 for each cancer site.
The primary cancer site is the applicable organ or tissue site where the cancer
originated. This question lists the ‘Main WHI Cancer Outcomes’ sites separate
from the ‘Other Cancer Outcomes’ sites.
If the primary cancer site is not listed under ‘Other Cancer Outcomes’ or is an
unknown site, mark ‘Box 00 - Other’ and hand write the site or indicate
‘unknown’ in the space provided.
Tips for primary cancer site:
• For the ‘Main WHI Cancer Outcomes’, breast only, complete the
required questions, Qx.1-3 and Qx.5-14.
• For the other ‘Main WHI Cancer Outcomes’ (ovary, corpus
uteri/endometrium, colon, rectum, rectosigmoid/rectosigmoid junction),
complete the required questions, Qx.1-3 and Qx.5-10.
• For the ‘Other Cancer Outcomes’, complete the required questions,
Qxs.1-6, to capture the fact of cancer. Note: Extension Study goal is to
apply SEER coding to all ‘Other Cancer Outcomes’ sites for WHI and
Extension Study primary sites.
• If the primary cancer site is listed under ‘Other Cancer Outcomes’,
check the box provided in Qx.2 but do not enter a site code for Qx.3.
• Do not code primary cancer site as the secondary or metastatic site of
the cancer.
• If ‘Box 00 - Other’ is marked, a corresponding ICD-O-2 (International
Classification of Diseases for Oncology, Second Edition) must be
entered in Qx3.
• Refer to Form 130 for the list of the ‘Main WHI Cancer Outcomes’ and
the ‘Other Cancer Outcomes’.

R:\DOC\EXT\FORMS\ENG\CURR\INST\I130V8.2.DOC 10/30/08

WHI Extension – Appendix A, Form 130 - Report of Cancer Outcome (Ver. 8.2)

3.

ICD-O-2-Code

4.

Tumor Behavior

Page 3

A numeric ICD-O-2 code is recorded for the primary cancer site indicated in
Qx. 2 for the ‘Main WHI Cancer Outcomes’ sites and those primary sites
handwritten in the ‘specify’ field for ‘Box 00 – Other’.
This item is completed only when a primary site list under ‘Other Cancer
Outcomes’ in Qx. 2 is checked.
Select one and only one category to classify the behavior of the tumor.
• Invasive; malignant; infiltraing; micro-invasive (code 1)
• In-situ, intraepithelial; non-infiltrating; non-invasive; intraductal (code
2)
• Borderline malignancy; low malignant potential; uncertain whether
benign or malignant; indeterminate malignancy (code 3)
• Unknown (code 9)
Tips for Tumor Behavior:
• Code ‘3’ is only used for ovary.

5.

Reporting Source

This is a hierarchical field, lower numbers take precedence over higher
numbers. Select the first applicable category.
• Hospital inpatient (code 1)
• Hospital outpatient/radiation or chemotherapy facility, surgical center,
or clinic (code 2)
• Laboratory only (hospital or private) including pathology office (code
3)
• Physician’s office/private medical practitioner (code 4)
• Nursing/convalescent home/hospice (code 5)
• Autopsy only (code 6)
• Death certificate only (code 7)

6.

Diagnostic Confirmation
Status

This item indicates the nature of the best evidence available on the diagnostic
confirmation of the cancer. This is a hierarchical field, lower numbers take
precedence over higher numbers. Select the first applicable category under the
3 headings ‘(Microscopically Confirmed’, ‘Not Microscopically Confirmed’,
‘Confirmation Unknown’) .
Microscopically Confirmed:
• Positive histology (pathology) (code 1)
• Positive exfoliative cytology, no positive histology (code 2)
• Positive histology (pathology), regional or distant metastatic site only
(code 3)
• Positive microscopic confirmation, method not specified (code 4)
Not Microscopically Confirmed:
• Positive laboratory test/marker study (code 5)
• Direct visualization without microscopic confirmation (code 6)
• Radiography and other imaging techniques without microscopic
confirmation (code 7)
• Clinical diagnosis only (other than 5, 6, or 7 above) (code 8)
Confirmation Unknown:
• Unknown if microscopically confirmed (code 9)

R:\DOC\EXT\FORMS\ENG\CURR\INST\I130V8.2.DOC 10/30/08

WHI Extension – Appendix A, Form 130 - Report of Cancer Outcome (Ver. 8.2)

Page 4

7.

Laterality

Mark the one laterality that is applicable for the primary site.
• Not a paired site (code 0)
• Right: origin of primary (code 1)
• Left: origin of primary (code 2)
• Only one side involved, right or left origin unspecified (code 3)
• Bilateral involvement, lateral origin unknown: stated to be single
primary (code 4)
• Paired site, but no information concerning laterality; midline tumor
(code 5)

8.

Morphology

The morphology code is a 6-digit code that includes the 4 digits of a common
root code for a particular cell type, the 5th digit indicating the behavior code,
and the 6th digit indicating the grading and/or differenctiation of the cancer.
The morphology coding for this field is from the ICD-O-2.
Example: A malignant poorly differentiated adenocarcinoma is coded as
814033:
• Root code: 8140 - adenocarcinoma
• Behavior code: 3 - malignant
• Grade: 3 - poorly differentiated

9.

EOD (SEER)

The EOD (extent of disease) is an estimate of the extent of disease based on all
the evidence available during the first couse of treatment (4 months from date of
diagnosis), in addition to the strictly clinical impression and any other evidence
derived from the complete work-up of the participant. The coding for these
EOD fields is site-specific.
The coding for EOD is broken into the following categories:
• Qx.9.1 – size of primary tumor
• Qx.9.2 – extension of tumor
• Qx.9.3 – lymph node status
• Qx.9.4 – number of regional nodes positive
• Qx.9.5 – number of regional nodes examined
Tips for EOD:
• Refer to appropriate SEER coding scheme for details of the codes.

10.

Summary Stage (SEER)

The summary stage is the grouping of cases with similar prognoses into broad
extent of disease categories, e.g., in-situ, localized, regional, distant, and
unknown spread. The staging is done in accordance with the SEER sitespecific summary staging schemes.
After the review of all evidence, mark the one appropriate stage of disease:
• In-situ (code 1)
• Localized (code 2)
• Regional (code 3)
• Distant (code 4)
• Unknown (code 9)

R:\DOC\EXT\FORMS\ENG\CURR\INST\I130V8.2.DOC 10/30/08

WHI Extension – Appendix A, Form 130 - Report of Cancer Outcome (Ver. 8.2)

Page 5

Items 11-14 are completed for breast cancer only.
11.

Complete the
subclassification for Breast
Histology 8522

Mark the one subclassification for the histology code 8522 – infiltrating duct
and lobular carcinoma:
• Not applicable (code 0)
• Ductal in-situ plus lobular in-situ (code 1)
• Ductal invasive plus lobular in-situ (code 2)
• Ductal invasive plus lobular invasive (code 3)
• Lobular invasive plus ductal in-situ (code 4)
• Invasive cancer, ductal and lobular NOS (code 5)

12.

Estrogen Receptor Assay

Mark the one category to indicate the result of the Estrogen Receptor Assay
(ERA), if it was ordered but the results are not available, or if it is unknown if
done or not done.
• Positive (code 1)
• Negative (code 2)
• Borderline (code 3)
• Ordered/Results not available (code 4)
• Unknown/Not done (code 5)

12.1

Date

Indicate the date the tissue was excised (that was used for the ERA).

12.2

Type of Assay

Mark the one category to indicate the type of ERA that was done.
• fmol/mg protein (code 1)
• ICC/IHC (code 2)
• Other, specify (code 8)
• Unknown (code 9)

13.

Progesterone Receptor
Assay

Mark the one category to indicate the result of the Progesterone Receptor Assay
(PRA), if it was ordered but the results are not available, or if it is unknown if
done or not done.
• Positive (code 1)
• Negative (code 2)
• Borderline (code 3)
• Ordered/Results not available (code 4)
• Unknown/Not done (code 5)

13.1

Date

Indicate the date the tissue was excised (that was used for the PRA).

13.2

Type of Assay

Mark the one category to indicate the type of PRA that was done.
• fmol/mg protein (code 1)
• ICC/IHC (code 2)
• Other, specify (code 8)
• Unknown (code 9)

14.

Her 2/Neu

Mark the one category to indicate the result of the Her 2/Neu, or that it was not
done or unknown if done.
• Positive (code 1)
• Negative (code 2)
• Borderline (code 3)
• Ordered/Results not available (code 4)
• Unknown/Not done (code 5)

R:\DOC\EXT\FORMS\ENG\CURR\INST\I130V8.2.DOC 10/30/08

WHI Extension – Appendix A, Form 130 - Report of Cancer Outcome (Ver. 8.2)

14.1

Date

Page 6

Indicate the date the tissue was excised (that was used for the Her 2/Neu).
Tips for ERA/PRA/Her 2/Neu assays:
• The ERA/PRA/Her 2/Neu assays are generally done on an invasive
tumor.
• Do not code the assay results if the tissue that was submitted was either
lymph nodes or metastatic sites.
• Code assay results from the primary site tissue.
• A FISH assay will overide the the Her 2/Neu since it will provide a
more specific result.
• If Qxs 12, 13, or 14 are coded ‘9-unknown/not done’, do not code 12.1,
12.2, 13.1, 13.2 or 14.1, respectively.

15.

Editor Code

ID of the CCC Cancer Coder who edited the form, if appropriate.

Cancer Coder Signature

The CCC Cancer Coder should sign the form only when the relevant items have
been filled in as completely and accurately as possible on the basis of the
information available.

R:\DOC\EXT\FORMS\ENG\CURR\INST\I130V8.2.DOC 10/30/08

WHI Extension – Appendix B, Form 132 - Report of Stroke Outcome (Ver. 8)

Page 1

FORM:

132 - REPORT OF STROKE OUTCOME

Version:

8 – October 1, 2005

Description:

3-page form filled out by the CCC Stroke Adjudicator after the diagnosis of a cerebrovascular
outcome. Key-entered at the CCC, as appropriate.

When used:

Completed when the CCC Stroke Adjudicator confirms that a WHI Extension Study participant
(Clinical Trial [CT] or Observational Study [OS]) has experienced a WHI Extension Studydefined cerebrovascular outcome. The form must also be completed to confirm a TIA or
hospitalized carotid artery disease.

Purpose:

To provide confirmation of a WHI Extension Study cerebrovascular outcome.

GENERAL INSTRUCTIONS

1.

A CCC Stroke Adjudicator must complete this form when a participant is confirmed as having had WHI Extension
Study cerebrovascular outcome.

2.

Obtain all available required documentation before filling out the form. (See Table 8.2.2 - Documentation
Requirements for WHI Extension Study Outcomes.)

3.

CCC Outcomes staff will place the participant's barcode label in the space provided at the top of the form and route
the form and a copy of the supporting medical record documents to the CCC Stroke Adjudicator for completion and
signature.

4.

When the CCC Stroke Adjudicator returns the completed form, the CCC Outcomes staff will review the form for
completeness and discuss any questions with the CCC Stroke Adjudicator. Send to data entry for key-entry.

5.

Data Entry: Key-enter the form and initial the first page of the form after key-entry.

6.

File a copy of the adjudication case packet [outcomes form(s)] and a copy of all documentation used in the
adjudication] in the participant’s outcomes file at the CCC.

7.

For additional details on adjudicating cardiovascular outcomes, refer to Section 8.5 - Outcomes Classification:
Cardiovascular Outcomes.

R:\DOC\EXT\FORMS\ENG\CURR\INST\I132V8.DOC 10/01/05

WHI Extension – Appendix B, Form 132 - Report of Stroke Outcome (Ver. 8)

Page 2

Item Instructions
Date completed

Month, day, year. Date that the form is completed by the Physician Adjudicator.

Adjudicator code

The 5-digit WHI Extension Study employee ID code for the Physician Adjudicator.

Adjudication case

The adjudication case number assigned in the WHIX database.

1.

Stroke

Yes/No. If non-fatal, complete Questions 1.1 to 1.7 and 1.9. If fatal, complete
Questions 1.1 to 1.9.

1.1

Date of admission or
diagnosis

The admit date on the hospital or outpatient medical records.

1.2

Diagnosis

Mark the one category that corresponds best to the CCC Stroke Adjudicator’s final
diagnosis.

1.3

Stroke during or
resulting from a
procedure

Yes/No/Unknown. Mark one.

1.4

Stroke requiring
hospitalization

Yes/No. Mark one.

1.5

Oxfordshire
classification

Mark the one category that applies best. A stroke assessment scale completed by a
Stroke Neurologist.

1.6

TOAST classification

Mark the one category that applies best. Trial of Org 10172 in Acute Stroke
Treatment (TOAST) classification. To be completed by the Stroke Neurologist.

1.7

Criteria for diagnosing
stroke

Mark the one category that applies best.

1.8

Criteria for diagnosing
fatal stroke

Mark all that apply and complete Form 124 – Final Report of Death. Indicate on
the Investigation Documentation Summary (IDS) Report that the death needs to be
adjudicated by the CVD Adjudicator.

1.9

Participant’s functional
status at hospital
discharge (Glasgow
Outcome Scale)

Mark the one category that applies best. Complete the Glasgow Outcome Scale at
the time of discharge from the medical service, using only current medical records
documentation provided in the case packet. Do not request additional medical
records to determine the Glasgow Outcomes Scale. If, based on currently available
medical records, you are unable to categorize the participant, mark Box 6 –
“Unable to categorize participant based on available case packet documentation.”

2.

TIA requiring
hospitalization

Yes/No. Mark the appropriate box and complete Question 2.1 if the participant has
evidence of TIA. Mark “Yes” for a report of an acute neurologic event that does
not satisfy the definition of a stroke but satisfies the definition given for a TIA.

2.1

Date of admission

The admit date on the hospital outpatient medical records.

3.

Carotid artery disease
requiring hospitalization

Yes/No. Mark the appropriate box and complete Question 3.1 to 3.3 to confirm the
carotid artery disease. Note the participant must be hospitalized (and symptomatic
or requiring intervention).

R:\DOC\EXT\FORMS\ENG\CURR\INST\I132V8.DOC 10/01/05

WHI Extension – Appendix B, Form 132 - Report of Stroke Outcome (Ver. 8)

Page 3

3.1

Date of admission

The admit date on the medical records.

3.2

Diagnosis

Mark the one box that corresponds best to the Physician Adjudicator’s final
diagnosis.

3.3

Criteria for diagnosing
carotid artery disease

Mark all that apply. Note the participant must be hospitalized (and symptomatic or
requiring intervention).

Responsible adjudicator
signature

The Physician Adjudicator should sign the form only when (s)he is satisfied that
the relevant items have been filled in as completely and accurately as possible on
the basis of the information available.

R:\DOC\EXT\FORMS\ENG\CURR\INST\I132V8.DOC 10/01/05