Protocol - Deep Venous Thrombosis
A screening question is asked about whether a person has been told that they have deep venous thrombosis (DVT) or blood clots in their legs. If the response is "yes," then two questions are asked about treatment for the condition. The third protocol provides a method to improve documentation of the condition by abstracting additional information from the persons medical record about the history and laboratory findings of DVT.
If the respondent answers "no" or "dont know" to question 1, the protocol is complete. If the respondent answers "yes," continue with the protocol.
This protocol refers to diagnoses during the subjects lifetime. For users wishing to collect longitudinal data, the question could be asked in relation to a previous study visit.
1. Has a doctor ever told you that you had deep venous thrombosis or blood clots in your legs?
9[ ]Dont Know
2. Have you ever been treated by a doctor or a nurse with shots at home or as an outpatient (usually followed by blood thinning medications such as Coumadin, Warfarin) for blood clots in the legs called deep vein thrombosis or DVT?
3. Have you ever had outpatient test(s) performed for blood clots in the legs called deep vein thrombosis or DVT?
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.
4. Deep vein thrombosis (DVT)
4a. Date of Diagnosis: (M/D/Y) ___ / ___ / _____
4b. Diagnosis: (Mark the one category that applies best.)
1[ ]Deep vein thrombosis of lower extremities not resulting from a procedure within 60 days
2[ ]Deep vein thrombosis of lower extremities during or following a procedure within 60 days
4c. Diagnosis of deep vein thrombosis is based on: (Mark all that apply.)
1[ ]Hospital discharge summary with a diagnosis of deep vein thrombosis
2[ ]Positive findings on a venogram
3[ ]Positive findings using impedance plethysmography
4[ ]Positive findings on doppler duplex, ultrasound, sonogram, or other non-invasive test examination
5[ ]Positive findings on isotope scan
4d. Diagnosis of deep vein thrombosis reporting source: (Mark one. If more than one category applies, mark the first applicable category.)
1[ ]Hospital inpatient
2[ ]Hospital outpatient facility or clinic
3[ ]Radiology or imaging facility
4[ ]Physicians office/private medical practitioner
5[ ]Nursing/convalescent home/hospice
6[ ]Autopsy only
7[ ]Death Certificate only
The presence of thrombus within a deep vein of a lower extremity only and the accompanying inflammatory response in vessel wall is termed deep vein thrombosis. The diagnosis can be made when the diagnosis is present in the discharge summary and any of the following are recorded:
- Positive findings on a venogram, defined as presence of a filling defect or absence of filling.
- Positive findings on impedance plethysmography, duplex scan, or ultrasound, defined as a report of a flow defect.
- Positive findings on doppler examination, defined as a demonstration of flow velocity disturbance.
- Positive findings on isotope scan (e.g., I125 fibrinogen scan).
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).
A trained and certified Hospital Record Abstractor is required to complete the protocol from the Womens Health Initiative, Form 126. This person should be trained on how to perform medical record and chart abstraction using various hospital records.
|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 deep venous thrombosis. The two protocols have been used on major U.S. health studies and are reliable and valid.
|caDSR Common Data Elements (CDE)||Person Deep Venous Thrombosis Indicator||2935425||CDE Browser|
|Logical Observation Identifiers Names and Codes (LOINC)||Deep venous thrombosis proto||62401-5||LOINC|
|Human Phenotype Ontology||Deep vein thrombosis||HP:0002625||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 9 (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 33D—Medical History Update. Version 4. Questions 3.3–3.5 (source for questions 2 and 3).
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). Question 1 (source for questions 4–4d).
Diagnostic Criteria: 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 8.1.1 (source for Diagnostic Criteria).
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|
|PX041201040000||Deep vein thrombosis (DVT)||Variable Mapping|
|PX041201040200||Integer, encoded values||N/A|
|PX041201040301||Diagnosis of deep vein thrombosis is based more||Variable Mapping|
|PX041201040303||Diagnosis of deep vein thrombosis is based more||Variable Mapping|
|PX041201040305||Diagnosis of deep vein thrombosis is based more||Variable Mapping|
|PX041201040304||Diagnosis of deep vein thrombosis is based more||Variable Mapping|
|PX041201040302||Diagnosis of deep vein thrombosis is based more||Variable Mapping|
|PX041201040100||Date of Diagnosis (mm/dd/yyyy).||N/A|
|PX041201040400||Diagnosis of deep vein thrombosis reporting more||Variable Mapping|
|PX041201020000||Have you ever been treated by a doctor or a more||N/A|
|PX041201010000||Has a doctor ever told you that you had deep more||Variable Mapping|
|PX041201030000||Have you ever had outpatient test(s) more||N/A|
Deep Venous Thrombosis
September 24, 2009
Measure to assess history of deep venous thrombosis.
To assess history of deep venous thrombosis and determine risk for pulmonary embolism.
Deep venous thrombosis, deep vein thrombosis, DVT, blood clot, Coumadin, Warfarin, personal history, Cardiovascular