Protocol - Pulmonary Embolism

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.

Availability

Available

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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).

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 Category	Required
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

Lifestage

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

Chinese, English, Other languages available at source

Standards

Standard	Name	ID	Source
Logical Observation Identifiers Names and Codes (LOINC)	PhenX - pulmonary embolus protocol	62402-3	LOINC
Human Phenotype Ontology	Pulmonary Embolism	HP:0002204	HPO
caDSR Form	PhenX PX041301 - Pulmonary Embolism	5849231	caDSR Form

Derived Variables

None

Process and Review

Not applicable.

Protocol Name from Source

Womens Health Initiative (WHI) & Cardiovascular Health Study (CHS)

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 ID	Variable Description	dbGaP 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, Womens Health Initiative, WHI, pulmonary embolism, embolus, blood clot, lung, personal history

Measure Protocols

Protocol ID	Protocol Name
41301	Pulmonary Embolism

Publications

Asare, E. V., et al. (2022) Acute pain episodes, acute chest syndrome, and pulmonary thromboembolism in pregnancy. Hematology-American Society of Hematology Education Program. 2022 December; 2022(1): 388-407. doi: 10.1182/hematology.2022000376

Mapping for PX041301_Ever_Have_Pulmonary_Embolism

dbGAP Study	dbGAP Variable	dbGAP Variable Description
Atherosclerosis Risk in Communities (ARIC) Cohort	phv00202930	[General health]. Has a doctor ever said you had any of the following? Blood clot in a leg [deep vein thrombosis] [Annual Follow-up Questionnaire Form, AFUG]
Atherosclerosis Risk in Communities (ARIC) Cohort	phv00202931	[General health]. Has a doctor ever said you had any of the following? Blood clot in a lungs [pulmonary embolus] [Annual Follow-up Questionnaire Form, AFUG]
Atherosclerosis Risk in Communities (ARIC) Cohort	phv00206786	Section 3: Medical History. Respiratory. Pulmonary embolus [Heart Failure Hospital Record Abstraction Form, HFA]
Atherosclerosis Risk in Communities (ARIC) Cohort	phv00207698	Has a doctor ever told you that you had a blood clot in a leg (deep vein thrombosis)? This does not include varicose veins or phlebitis. Q9A [Medical History Questionnaire, exam 4]
Atherosclerosis Risk in Communities (ARIC) Cohort	phv00207699	Has a doctor ever told you that you had a blood clot in your lungs (pulmonary embolus)? Q10A [Medical History Questionnaire, exam 4]
CARDIA Cohort	phv00121342	DIAGNOSIS FOR DEEP VEIN THROMBOSIS
CARDIA Cohort	phv00121561	DIAGNOSIS FOR DEEP VEIN THROMBOSIS
Cardiovascular Health Study (CHS) Cohort	phv00099028	PULMONARY EMBOLUS/BLOOD CLOTS IN LUNGS
Cardiovascular Health Study (CHS) Cohort	phv00100325	DEEP VEIN THROMBOSIS
Cardiovascular Health Study (CHS) Cohort	phv00100326	PULMONARY EMBOLUS/BLOOD CLOTS IN LUNGS
Cardiovascular Health Study (CHS) Cohort	phv00105971	PULMONARY EMBOLUS/BLOOD CLOTS IN LUNGS
Framingham Cohort	phv00007028	VENOUS DISEASE: DEEP VEIN THROMBOSIS (BLOOD CLOTS IN LEGS OR ARMS) - LEFT
Framingham Cohort	phv00007029	VENOUS DISEASE: DEEP VEIN THROMBOSIS (BLOOD CLOTS IN LEGS OR ARMS) - RIGHT
Framingham Cohort	phv00007461	VENOUS DISEASE: DEEP VEIN THROMBOSIS (BLOOD CLOTS IN LEGS OR ARMS)
Framingham Cohort	phv00010342	VENOUS DISEASE: DEEP VEIN THROMBOSIS (BLOOD CLOTS IN LEGS OR ARMS) - LEFT
Framingham Cohort	phv00010343	VENOUS DISEASE: DEEP VEIN THROMBOSIS (BLOOD CLOTS IN LEGS OR ARMS) - RIGHT
Framingham Cohort	phv00010478	CDI: DEEP VEIN THROMBOSIS
Framingham Cohort	phv00021065	HAVE YOU EVER HAD A DEEP VEIN THROMBOSIS (BLOOD IN LEG OR ARMS)
Framingham Cohort	phv00021066	HAVE YOU EVER HAD A PULMONARY EMBOLUS (BLOOD CLOT IN LUNGS)
Genetic Epidemiology of COPD (COPDGene)	phv00159616	Blood clots [in legs or lungs]
Jackson Heart Study (JHS) Cohort	phv00124997	7e. Blood clot in a leg or deep vein thrombosis
Jackson Heart Study (JHS) Cohort	phv00124998	7f. Blood clot in your lungs or pulmonary embolus
Jackson Heart Study (JHS) Cohort	phv00125082	7e. Blood clot in a leg or deep vein thrombosis
Jackson Heart Study (JHS) Cohort	phv00125083	7f. Blood clot in your lungs or pulmonary embolus
Jackson Heart Study (JHS) Cohort	phv00125167	7e. Blood clot in a leg or deep vein thrombosis
Jackson Heart Study (JHS) Cohort	phv00125168	7f. Blood clot in your lungs or pulmonary embolus
Jackson Heart Study (JHS) Cohort	phv00125253	7e. Blood clot in a leg or deep vein thrombosis
Jackson Heart Study (JHS) Cohort	phv00125254	7f. Blood clot in your lungs or pulmonary embolus
Jackson Heart Study (JHS) Cohort	phv00125367	16. Has a doctor ever said that you had a blood clot in a leg or deep vein thrombosis?
Jackson Heart Study (JHS) Cohort	phv00125371	17a. Has a doctor ever said that you had a blood clot in your lungs or a pulmonary embolus?
Multi-Ethnic Study of Atherosclerosis (MESA) Cohort	phv00082986	BLOOD CLOTS IN LEGS/LUNGS: SELF-REPORT
Multi-Ethnic Study of Atherosclerosis (MESA) Cohort	phv00085222	BLOOD CLOTS IN LEGS/LUNGS: SELF-REPORT
Multi-Ethnic Study of Atherosclerosis (MESA) Cohort	phv00087130	BLOOD CLOTS IN LUNG OR LEG VEINS
NIA Long Life Family Study (LLFS)	phv00163272	Deep Vein Thrombosis or Pulmonary Embolism diagnosed?
Women's Health Initiative	phv00078475	Pulmonary embolism ever
Women's Health Initiative	phv00079310	F40 Family member ever have a pulmonary embolus (PE)
Women's Health Initiative	phv00080148	Deep Vein Thrombosis
Women's Health Initiative	phv00080150	Deep vein thrombosis source of outcome review (central vs. local)
Women's Health Initiative	phv00080151	Pulmonary Embolism
Women's Health Initiative	phv00080296	Deep Vein Thrombosis
Women's Health Initiative	phv00080298	Deep vein thrombosis source of outcome review (central vs. local)
Women's Health Initiative	phv00080299	Pulmonary Embolism
Women's Health Initiative	phv00080308	F33 Deep Vein Thrombosis
Women's Health Initiative	phv00080310	F33 Pulmonary embolism
Women's Health Initiative	phv00080366	F33 Deep Vein Thrombosis
Women's Health Initiative	phv00080368	F33 Pulmonary embolism
Women's Health Initiative	phv00111081	Deep Vein Thrombosis (DVT)
Women's Health Initiative	phv00111082	Pulmonary Embolism (PE)
Women's Health Initiative	phv00111083	F126 DVT diagnosis
Women's Health Initiative	phv00111084	F126 DVT based on hospital discharge summary
Women's Health Initiative	phv00111085	F126 DVT based on positive findings on venogram
Women's Health Initiative	phv00111086	DVT positive findings impedance plethysmography
Women's Health Initiative	phv00111087	F126 DVT positive findings on doppler
Women's Health Initiative	phv00111088	F126 DVT positive findings on isotope
Women's Health Initiative	phv00111089	F126 diagnosis DVT report source
Women's Health Initiative	phv00111099	Deep Vein Thrombosis (DVT)
Women's Health Initiative	phv00111100	Pulmonary Embolism (PE)
Women's Health Initiative	phv00111101	F126 DVT diagnosis
Women's Health Initiative	phv00111102	F126 DVT based on hospital discharge summary
Women's Health Initiative	phv00111103	F126 DVT based on positive findings on venogram
Women's Health Initiative	phv00111104	DVT positive findings impedance plethysmography
Women's Health Initiative	phv00111105	F126 DVT positive findings on doppler
Women's Health Initiative	phv00111106	F126 DVT positive findings on isotope
Women's Health Initiative	phv00111108	F126 PE work up done
Women's Health Initiative	phv00155660	Deep Vein Thrombosis (DVT)
Women's Health Initiative	phv00155672	Pulmonary Embolism (PE)
Women's Health Initiative	phv00155953	Deep Vein Thrombosis (DVT)
Women's Health Initiative	phv00155965	Pulmonary Embolism (PE)
Women's Health Initiative	phv00156210	F33 Deep Vein Thrombosis
Women's Health Initiative	phv00156212	F33 Pulmonary Embolism
Women's Health Initiative	phv00156298	F33 Deep Vein Thrombosis
Women's Health Initiative	phv00156300	F33 Pulmonary Embolism
Women's Health Initiative	phv00169693	Deep Vein Thrombosis (DVT)
Women's Health Initiative	phv00169705	Pulmonary Embolism (PE)
Women's Health Initiative	phv00170196	Deep Vein Thrombosis (DVT)
Women's Health Initiative	phv00170208	Pulmonary Embolism (PE)
Women's Health Initiative	phv00170492	Deep Vein Thrombosis (DVT)
Women's Health Initiative	phv00170493	Pulmonary Embolism (PE)
Women's Health Initiative	phv00170494	F126 DVT diagnosis
Women's Health Initiative	phv00170495	F126 DVT based on hospital discharge summary
Women's Health Initiative	phv00170496	F126 DVT based on positive findings on venogram
Women's Health Initiative	phv00170497	DVT positive findings impedance plethysmography
Women's Health Initiative	phv00170498	F126 DVT positive findings on doppler
Women's Health Initiative	phv00170499	F126 DVT positive findings on isotope
Women's Health Initiative	phv00170567	F33 Deep Vein Thrombosis
Women's Health Initiative	phv00170569	F33 Pulmonary Embolism
Women's Health Initiative	phv00170649	F33 Deep Vein Thrombosis
Women's Health Initiative	phv00170651	F33 Pulmonary Embolism
Women's Health Initiative	phv00193554	DVT
Women's Health Initiative	phv00193555	PE
Women's Health Initiative	phv00193556	F126 DVT diagnosis
Women's Health Initiative	phv00193557	F126 DVT based on hospital discharge summary
Women's Health Initiative	phv00193558	F126 DVT based on positive findings on venogram
Women's Health Initiative	phv00193559	DVT positive findings impedance plethysmography
Women's Health Initiative	phv00193560	F126 DVT positive findings on doppler
Women's Health Initiative	phv00193561	F126 DVT positive findings on isotope
Women's Health Initiative	phv00193562	F126 diagnosis DVT report source
Women's Health Initiative	phv00193689	F33 Outpatient Deep Vein Thrombosis
Women's Health Initiative	phv00193691	F33 Hospitalized Pulmonary Embolism
Women's Health Initiative	phv00193693	F33 Outpatient Pulmonary Embolism
Women's Health Initiative	phv00202394	F33 Deep Vein Thrombosis

Mapping for PX041301_PE_Diagnosis

dbGAP Study	dbGAP Variable	dbGAP Variable Description
Women's Health Initiative	phv00111091	F126 PE diagnosis
Women's Health Initiative	phv00111109	F126 PE diagnosis
Women's Health Initiative	phv00170502	F126 PE diagnosis
Women's Health Initiative	phv00193564	F126 PE diagnosis

Mapping for PX041301_PE_Hospitalization

dbGAP Study	dbGAP Variable	dbGAP Variable Description
Women's Health Initiative	phv00111092	F126 PE based on hospital discharge summary
Women's Health Initiative	phv00111110	F126 PE based on hospital discharge summary
Women's Health Initiative	phv00170503	F126 PE based on hospital discharge summary
Women's Health Initiative	phv00193565	F126 PE based on hospital discharge summary
Women's Health Initiative	phv00193691	F33 Hospitalized Pulmonary Embolism