Protocol - Pulmonary Embolism
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.
If "Yes" to question 1, continue with protocol. If "No," then continuing the protocol is unnecessary.
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
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).
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).
|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
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.
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.
|caDSR 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|
|Human Phenotype Ontology||Pulmonary Embolism||HP:0002204||HPO|
Process and Review
Protocol Name from 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).
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
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.
|Variable Name||Variable ID||Variable Description||dbGaP Mapping|
|PX041301010000||Has a doctor ever told you that you had more||Variable Mapping|
|PX041301040000||Diagnosis: (Mark the one category that more||Variable Mapping|
|PX041301050000||Diagnosis of pulmonary embolism is based on: more||N/A|
|PX041301030000||Date of Diagnosis (mm/dd/yyyy).||N/A|
|PX041301020000||Pulmonary embolism (PE) requiring hospitalization:||Variable Mapping|
September 9, 2009
Measure to assess the history of blood clots in the lungs, which is also known as pulmonary embolism.
To assess history of pulmonary embolism.
cardiovascular, Cardiovascular Health Study, CHS, Women's Health Initiative, WHI, pulmonary embolism, embolus, blood clot, lung, personal history