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Protocol - Pulmonary Embolism

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Description:

A screening question is asked about whether a person has been told that they have pulmonary embolus or blood clots. If the response is yes, then the second protocol provides a method for abstracting additional information from the persons medical record about the history of pulmonary embolism.

Specific Instructions:

If "Yes" to question 1, continue with protocol. If "No," then continuing the protocol is unnecessary.

Protocol:

1. Has a doctor ever told you that you had pulmonary embolus or blood clots in your lungs?

[ ] 1 Yes

[ ] 0 No

[ ] 9 Dont Know

Complete the following for all hospitalized pulmonary embolism (PE)/deep vein thrombosis (DVT).

Complete the following if Outpatient (OP) records confirm deep vein thrombosis (DVT) or an autopsy report confirms pulmonary embolism.

2. Pulmonary embolism (PE) requiring hospitalization:

3. Date of Diagnosis: (M/D/Y) __ / __ / ____

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

[ ] 1 Pulmonary embolism not resulting from a procedure within 60 days

[ ] 2 Pulmonary embolism during or following a procedure within 60 days

5. Diagnosis of pulmonary embolism is based on:

(Mark all that apply.)

[ ] 1 Hospital discharge summary with a diagnosis of pulmonary embolism

[ ] 2 High probability on ventilation-perfusion lung scan (exclude moderate, intermediate, or low probability on ventilation-perfusion lung scan)

[ ] 3 Positive findings on pulmonary angiogram or spiral CAT scan (CT).

[ ] 4 Diagnosis of deep vein thrombosis (DVT) based on ≥1 deep vein thrombosis (DVT) criteria in question 1.3 (link to Form 126 in Source section below) plus signs and symptoms suggestive of pulmonary embolism (PE) (e.g., acute chest pain, dyspnea, tachypnea, hypoxemia, tachycardia, or chest x-ray findings suggestive of pulmonary embolism)

[ ] 8 Other, including autopsy

Diagnostic Criteria:

Pulmonary embolism (PE) is defined as present if the following are present:

  • Pulmonary embolism reported as a diagnosis in the discharge summary AND
  • Report of a positive findings on appropriate diagnostic studies, including:
    • Pulmonary ventilation/perfusion (V/Q) report describing either "high" or "moderate" probability of deficit ("low" probability V/Q studies will not be considered evidence for presence of pulmonary embolism).
    • Pulmonary angiography report describing either "cut off" of a vessel or "filling defect."
  • Diagnosis of deep vein thrombosis (DVT) based on ≥1 DVT criteria (see Manual 8, Section 8.1.1 - Deep Vein Thrombosis) plus signs and symptoms of pulmonary embolism (i.e., acute chest pain, dyspnea, tachypnea, hypoxemia, tachycardia, or chest X-ray findings characteristic of pulmonary embolism).

Protocol Name from Source:

Availability:

Publicly available

Personnel and Training Required

An interviewer who is trained to conduct personal interviews with individuals from the general population is required. The interviewer must be trained and found to be competent (i.e., tested by an expert) at the completion of personal interviews.* The interviewer should be trained to prompt respondents further if a "dont know" response is provided. Additionally, this person should be trained on how to perform medical record and chart abstraction.

*There are multiple modes to administer this question (e.g., paper-and-pencil and computer-assisted interviews).

Equipment Needs

None

Requirements
Requirement CategoryRequired
Major equipment No
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Interviewer-administered question, Medical record abstraction

Life Stage:

Adult

Participants:

Cardiovascular Health Study (CHS): ≥65 years old

Womens Health Initiative (WHI): Women ages 50–79 years old*

*While this questionnaire was used in a womens study, the Cardiovascular Working Group deems it appropriate to use with men.

Selection Rationale

The combination of these two protocols provides sufficient evidence to determine a history of pulmonary embolism. The two protocols have been used on major U.S. health studies and are reliable and valid.

Language

English, Spanish

Standards
StandardNameIDSource
Common Data Elements (CDE) Person Pulmonary Embolism Indicator 2935430 CDE Browser
Logical Observation Identifiers Names and Codes (LOINC) PhenX - pulmonary embolus protocol 62402-3 LOINC
Derived Variables

None

Process and Review

Not applicable.

Source

U.S. Department of Health and Human Services. National Institutes of Health. National Heart, Lung and Blood Institute. Cardiovascular Health Study (CHS). Baseline Medical History Questionnaire. Page 5. Question 10 (source for question 1).

U.S. Department of Health and Human Services. National Institutes of Health. National Heart, Lung and Blood Institute. Womens Health Initiative (WHI). Form 126—Report of Venous Thromboembolic Disease (HRT). No question numbers provided (source for questions 2–5).

http://www.whiscience.org/data/forms/F126v4_1.pdf

U.S. Department of Health and Human Services. National Institutes of Health. National Heart, Lung and Blood Institute. Womens Health Initiative (WHI). Volume 8, Section 8—Other Outcomes. Subsection 8.1.2 (source for Diagnostic Criteria). http://www.whiscience.org/about/manual/manual_8_8.pdf

General References

Ives, D. G., Fitzpatrick, A. L., Bild, D. E., Psaty, B. M., Kuller, L. H., Crowley, P. M., Cruise, R. G., & Theroux, S. (1995). Surveillance and ascertainment of cardiovascular events. The Cardiovascular Health Study. Annals of Epidemiology, 5, 278–285.

Psaty, B. M., Kuller, L. H., Bild, D., Burke, G. L., Kittner, S. J., Mittelmark, M., Price, T. R., Rautaharju, P. M., & Robbins, J. (1995). Methods of assessing prevalent cardiovascular disease in the Cardiovascular Health Study. Annals of Epidemiology, 5(4), 270–277.

Protocol ID:

41301

Variables:
Export Variables
Variable Name Variable IDVariable DescriptiondbGaP Mapping
PX041301_Ever_Have_Pulmonary_Embolism
PX041301010000 Has a doctor ever told you that you had more
pulmonary embolus or blood clots in your lungs? show less
Variable Mapping
PX041301_PE_Diagnosis
PX041301040000 Diagnosis: (Mark the one category that more
applies best.) show less
Variable Mapping
PX041301_PE_Diagnosis_Based_On
PX041301050000 Diagnosis of pulmonary embolism is based on: more
(Mark all that apply.) show less
N/A
PX041301_PE_Diagnosis_Date
PX041301030000 Date of Diagnosis (mm/dd/yyyy). N/A
PX041301_PE_Hospitalization
PX041301020000 Pulmonary embolism (PE) requiring hospitalization: Variable Mapping
Cardiovascular
Measure Name:

Pulmonary Embolism

Release Date:

September 9, 2009

Definition

Measure to assess the history of blood clots in the lungs, which is also known as pulmonary embolism.

Purpose

To assess history of pulmonary embolism.

Keywords

cardiovascular, Cardiovascular Health Study, CHS, Women's Health Initiative, WHI, pulmonary embolism, embolus, blood clot, lung, personal history