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CDE Detailed Report
This report contains detailed information about the selected CDEs.
Note: If at least one CDE was selected from a copyright- or trademark-protected instrument/scale then all of the CDEs from that instrument/scale are included in this report.
Disease: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Sub-Domain: Autonomic
CRF: Passive Standing Test Protocol
Item count: 7 (7 distinct CDEs)
CDE ID
CDE Name
Variable Name
Definition / Description
Question Text
Permissible Value
Description
Data Type
Instructions
References
Population
Classification (e.g., Core)
Version #
Version Date
Aliases for Variable Name
CRF Module / Guideline
© or TM
Sub-Domain
Domain
Previous Title
Size
Input Restrictions
Min Value
Max Value
Measurement Type
LOINC ID
SNOMED
caDSR ID
CDISC ID
C19500
Assessment performed date
AssessmentPerformedDate
The date of assessment of the examination being performed.
Date of test
  
Date or Date & Time
Please see the Data Dictionary for definitions for each of the data elements included in this CRF Module.
? Date of test – Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (Please click here for the International Organization for Standardization website). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).
Hyatt KH, Jacobson LB, Schneider VS. Comparison of 70°tilt, LBNP, and passive standing as measures of orthostatic tolerance. Aviat Space Environ Med 1975;46: 801-808
Adult;Pediatric
Supplemental–Highly Recommended
1.0
6/18/2014
Aliases for variable name not defined
Passive Standing Test Protocol
Autonomic
Assessments and Examinations
  
Free-Form Entry
       
C02014
Medication prior or concomitant name
MedctnPriorConcomName
Name of the prior/concomitant agent or drug administered.
List medications taken in last 2 weeks
  
Alphanumeric
No instructions available
References
Hyatt KH, Jacobson LB, Schneider VS. Comparison of 70°tilt, LBNP, and passive standing as measures of orthostatic tolerance. Aviat Space Environ Med 1975;46: 801-808
Adult;Pediatric
Supplemental–Highly Recommended
3.0
8/28/2013
Aliases for variable name not defined
Passive Standing Test Protocol
Autonomic
Assessments and Examinations
Medication prior or concomitant name
4000
Free-Form Entry
     
3162728
 
C19361
Lab test participant position type
LabTestParticipntPositnTyp
The arrangement or orientation of the participant's body at the time the lab test was performed.
Position of participant
Supine before;Standing;Supine after;
Supine before;Standing;Supine after;
Alphanumeric
The following is a modification of the passive standing test (Hyatt KH, Jacobson LB, Schneider VS. Comparison of 70°tilt, LBNP, and passive standing as measures of orthostatic tolerance. Aviat Space Environ Med 1975;46: 801-808). The standing test begins with the subject lying supine, with shoes and socks removed, with an automated BP cuff set to record BP and HR at 1-minute intervals. The subject is supine for 5 minutes. The baseline heart rate (HR) and blood pressure (BP) are measured and recorded each minute for 5 minutes’ supine. At the 4-5 minute point, record the intensity of the patient's current symptoms (on a 0-10 scale).
The patient is then instructed to stand, with the heels 2-6 inches away from the wall, and with the upper back leaning against the wall in a comfortable but motionless position for a maximum of 10 minutes. Each minute, HR and BP are recorded and the patient is asked about symptoms, for a maximum of 10 minutes upright. At the conclusion of the standing period, the patient is instructed to lie supine again, while the BP, HR and symptom intensity are measured for a further 2 minutes.

Specific instructions are as follows:
“We’d like you to stand as still as possible for up to 10 minutes. During the standing test, you must be as motionless as possible in order to get an accurate result. Therefore, try not to wiggle your toes or fingers, scratch your nose, or move your arms or legs. We will monitor for any movements and will remind you not to move or wiggle. We want you to tell us if you are feeling anything different or uncomfortable during the test. Be as specific as possible. We need to know if you feel you can’t stay standing any longer, and if this is the case you can sit down. It is not necessary to remain standing for the entire 10 minutes, but we’d like to measure how long you can do this. Each minute we will check your blood pressure and heart rate with an automatic measuring device.”
Hyatt KH, Jacobson LB, Schneider VS. Comparison of 70°tilt, LBNP, and passive standing as measures of orthostatic tolerance. Aviat Space Environ Med 1975;46: 801-808
Adult;Pediatric
Supplemental–Highly Recommended
1.0
6/12/2014
Aliases for variable name not defined
Passive Standing Test Protocol
Autonomic
Assessments and Examinations
  
Single Pre-Defined Value Selected
     
2008432
 
C58394
Position held minute text
PosHeldMinTxt
The time in minutes a position is held
Minute
  
Alphanumeric
The following is a modification of the passive standing test (Hyatt KH, Jacobson LB, Schneider VS. Comparison of 70°tilt, LBNP, and passive standing as measures of orthostatic tolerance. Aviat Space Environ Med 1975;46: 801-808). The standing test begins with the subject lying supine, with shoes and socks removed, with an automated BP cuff set to record BP and HR at 1-minute intervals. The subject is supine for 5 minutes. The baseline heart rate (HR) and blood pressure (BP) are measured and recorded each minute for 5 minutes’ supine. At the 4-5 minute point, record the intensity of the patient's current symptoms (on a 0-10 scale).
The patient is then instructed to stand, with the heels 2-6 inches away from the wall, and with the upper back leaning against the wall in a comfortable but motionless position for a maximum of 10 minutes. Each minute, HR and BP are recorded and the patient is asked about symptoms, for a maximum of 10 minutes upright. At the conclusion of the standing period, the patient is instructed to lie supine again, while the BP, HR and symptom intensity are measured for a further 2 minutes.

Specific instructions are as follows:
“We’d like you to stand as still as possible for up to 10 minutes. During the standing test, you must be as motionless as possible in order to get an accurate result. Therefore, try not to wiggle your toes or fingers, scratch your nose, or move your arms or legs. We will monitor for any movements and will remind you not to move or wiggle. We want you to tell us if you are feeling anything different or uncomfortable during the test. Be as specific as possible. We need to know if you feel you can’t stay standing any longer, and if this is the case you can sit down. It is not necessary to remain standing for the entire 10 minutes, but we’d like to measure how long you can do this. Each minute we will check your blood pressure and heart rate with an automatic measuring device.”
Hyatt KH, Jacobson LB, Schneider VS. Comparison of 70°tilt, LBNP, and passive standing as measures of orthostatic tolerance. Aviat Space Environ Med 1975;46: 801-808
Adult;Pediatric
Supplemental–Highly Recommended
1.0
2/8/2018
Aliases for variable name not defined
Passive Standing Test Protocol
Autonomic
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C01521
Heart rate
HeartRate
The participant/subject's pulse or number of contractions (heart beats) per minute
Heart rate
  
Numeric Values
Specific instructions are as follows:
“We’d like you to stand as still as possible for up to 10 minutes. During the standing test, you must be as motionless as possible in order to get an accurate result. Therefore, try not to wiggle your toes or fingers, scratch your nose, or move your arms or legs. We will monitor for any movements and will remind you not to move or wiggle. We want you to tell us if you are feeling anything different or uncomfortable during the test. Be as specific as possible. We need to know if you feel you can’t stay standing any longer, and if this is the case you can sit down. It is not necessary to remain standing for the entire 10 minutes, but we’d like to measure how long you can do this. Each minute we will check your blood pressure and heart rate with an automatic measuring device.”
Hyatt KH, Jacobson LB, Schneider VS. Comparison of 70°tilt, LBNP, and passive standing as measures of orthostatic tolerance. Aviat Space Environ Med 1975;46: 801-808
Adult;Pediatric
Supplemental–Highly Recommended
3.0
8/28/2013
SCI CDEs: PULSE
Passive Standing Test Protocol
Autonomic
Assessments and Examinations
Heart rate
 
Free-Form Entry
0
300
beats per minute
  
2767073
 
C19565
Blood Pressure measurement
BldPressMeasr
Blood pressure measurement with systolic measurement over diastolic measurement
Blood pressure
  
Numeric Values
“We’d like you to stand as still as possible for up to 10 minutes. During the standing test, you must be as motionless as possible in order to get an accurate result. Therefore, try not to wiggle your toes or fingers, scratch your nose, or move your arms or legs. We will monitor for any movements and will remind you not to move or wiggle. We want you to tell us if you are feeling anything different or uncomfortable during the test. Be as specific as possible. We need to know if you feel you can’t stay standing any longer, and if this is the case you can sit down. It is not necessary to remain standing for the entire 10 minutes, but we’d like to measure how long you can do this. Each minute we will check your blood pressure and heart rate with an automatic measuring device.”
Hyatt KH, Jacobson LB, Schneider VS. Comparison of 70°tilt, LBNP, and passive standing as measures of orthostatic tolerance. Aviat Space Environ Med 1975;46: 801-808
Adult;Pediatric
Supplemental–Highly Recommended
1.0
12/19/2014
Aliases for variable name not defined
Passive Standing Test Protocol
Autonomic
Assessments and Examinations
  
Free-Form Entry
       
C18027
Comment text
CmmntTxt
Provide any additional information that pertains to the question.
Comments/Symptom ratings
  
Alphanumeric
Medication taken should be documented in the Medication Log CRF. Decisions about whether to allow study participants to remain on vasoactive medications are specific to the study question. In studies that examine the prevalence of orthostatic intolerance among those with ME/CFS, study participants would stop all vasoactive medications before the study. However, stopping medications is not always safe (for example, discontinuing an SSRI/SNRI medication could cause harm). Conversely, a study examining improvement in quality of life and orthostatic tolerance in response to treatment would need to allow participants to remain on medications during testing.

If the subject reports any changes in their ME/CFS symptoms or emergence of orthostatic signs and symptoms (see bolded abbreviations above), list these in the comments column along with the corresponding time recorded for the BP and HR. The comment section should note the changes in symptom severity on a 0-10 scale, and grade the physical sign of acrocyanosis as absent, mild, moderate, or severe. The comments should note if and when the subject had to sit down before the completion of 10 minutes upright, and, if so, mention whether the final upright BP was performed sitting or standing. The reason for stopping should be noted in the Comments section.
Hyatt KH, Jacobson LB, Schneider VS. Comparison of 70°tilt, LBNP, and passive standing as measures of orthostatic tolerance. Aviat Space Environ Med 1975;46: 801-808
Adult;Pediatric
Supplemental–Highly Recommended
3.0
7/16/2013
Aliases for variable name not defined
Passive Standing Test Protocol
Autonomic
Assessments and Examinations
 
4000
Free-Form Entry
       
12-14-2018
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