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Protocol - Deep Venous Thrombosis

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Protocol Name from Source:

The Expert Review Panel has not reviewed this measure yet.

Availability:

Publicly available

Description:

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 person's medical record about the history and laboratory findings of DVT.

Protocol:

1. Has a doctor ever told you that you had deep venous thrombosis or blood clots in your legs?

[ ] 1 Yes

[ ] 0 No

[ ] 9 Don't 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?

[ ] 1 Yes

[ ] 0 No

3. Have you ever had outpatient test(s) performed for blood clots in the legs called deep vein thrombosis or DVT?

[ ] 1 Yes

[ ] 0 No

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)

[ ] 1 Yes

[ ] 2 No

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 Physician's office/private medical practitioner

[ ] 5 Nursing/convalescent home/hospice

[ ] 6 Autopsy only

[ ] 7 Death Certificate only

[ ] 8 Other

Diagnostic Criteria:

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 "don't 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 Women's Health Initiative, Form 126. This person should be trained on how to perform medical record and chart abstraction using various hospital records.

Equipment Needs

None

Requirements

Requirement CategoryRequired
Average time of greater than 15 minutes in an unaffected individualNo
Major equipmentNo
Specialized requirements for biospecimen collectionNo
Specialized trainingYes

Mode of Administration

Self-administered

Life Stage:

Adult

Specific Instructions:

If the respondent answers "no" or "don't know" to question 1, the protocol is complete. If the respondent answers "yes," continue with the protocol.

This protocol refers to diagnoses during the subject's lifetime. For users wishing to collect longitudinal data, the question could be asked in relation to a previous study visit.

Research Domain Information

Release Date:

September 24, 2009

Definition

Measure to assess history of deep venous thrombosis.

Purpose

To assess history of deep venous thrombosis and determine risk for pulmonary embolism.

Selection Rationale

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.

Language

English

Standards

StandardNameIDSource
Common Data Elements (CDE)Person Deep Venous Thrombosis Indicator2935425CDE Browser
Logical Observation Identifiers Names and Codes (LOINC)Deep venous thrombosis proto62401-5LOINC

Process and Review

The Expert Review Panel has not reviewed this measure yet.

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. Women’s 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. Women’s 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. Women’s Health Initiative (WHI). Volume 8, Section 8—Other Outcomes. Subsection 8.1.1 (source for Diagnostic Criteria).

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:

41201

Variables:

Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX041201_Ever_Have_Deep_Venous_ThrombosisPX041201010000Has a doctor ever told you that you had deep venous thrombosis or blood clots in your legs?4N/A
PX041201_Ever_Been_TreatedPX041201020000Have 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?4N/A
PX041201_Ever_Have_Outpatient_TestPX041201030000Have you ever had outpatient test(s) performed for blood clots in the legs called deep vein thrombosis or DVT?4N/A
PX041201_DVTPX041201040000Deep vein thrombosis (DVT)4N/A
PX041201_DVT_Diagnosis_DatePX041201040100Date of Diagnosis (mm/dd/yyyy).4N/A
PX041201_DVT_DIAGNOSISPX041201040200Integer, encoded values4N/A
PX041201_DVT_Diagnosis_Based_On_Discharge_SummaryPX041201040301Diagnosis of deep vein thrombosis is based on: 1 = Hospital discharge summary with a diagnosis of deep vein thrombosis4N/A
PX041201_DVT_Diagnosis_Based_On_VenogramPX041201040302Diagnosis of deep vein thrombosis is based on: 2 = Positive findings on a venogram4N/A
PX041201_DVT_Diagnosis_Based_On_Impedance_PlethysmographyPX041201040303Diagnosis of deep vein thrombosis is based on: 3 = Positive findings using impedance plethysmography4N/A
PX041201_DVT_Diagnosis_Based_On_NoninvasivePX041201040304Diagnosis of deep vein thrombosis is based on: 4 = Positive findings on doppler duplex, ultrasound, sonogram, or other non-invasive test examination4N/A
PX041201_DVT_Diagnosis_Based_On_Isotope_ScanPX041201040305Diagnosis of deep vein thrombosis is based on: 5 = Positive findings on isotope scan4N/A
PX041201_DVT_Diagnosis_Reporting_SourcePX041201040400Diagnosis of deep vein thrombosis reporting source: (Mark one. If more than one category applies, mark the first applicable category.)4N/A