CDE Detailed Report

Disease: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Sub-Domain: Autonomic
CRF: Passive Standing Test Protocol

Displaying 1 - 7 of 7
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C01521 Heart rate HeartRate The participant/subject's pulse or number of contractions (heart beats) per minute 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 3.00 2013-08-28 16:08:00.453 Passive Standing Test Protocol Autonomic Assessments and Examinations

Free-Form Entry

0 300 beats per minute 2767073
C02014 Medication prior or concomitant name MedctnPriorConcomName Name of the prior/concomitant agent or drug administered. Name of the prior/concomitant agent or drug administered. List medications taken in last 2 weeks Alphanumeric References<br />Hyatt KH, Jacobson LB, Schneider VS. Comparison of 70&deg;tilt, LBNP, and passive standing as measures of orthostatic tolerance. Aviat Space Environ Med 1975;46: 801-808 Adult;Pediatric Supplemental?Highly Recommended 3.00 2013-08-28 16:08:00.453 Passive Standing Test Protocol Autonomic Assessments and Examinations 4000

Free-Form Entry

3162728
C18027 Comment text CmmntTxt Provide any additional information that pertains to the question. 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&deg;tilt, LBNP, and passive standing as measures of orthostatic tolerance. Aviat Space Environ Med 1975;46: 801-808 Adult;Pediatric Supplemental?Highly Recommended 3.00 2013-07-16 14:01:43.01 Passive Standing Test Protocol Autonomic Assessments and Examinations 4000

Free-Form Entry

C19361 Lab test participant position type LabTestParticipntPositnTyp The arrangement or orientation of the participant's body at the time the lab test was performed. The arrangement or orientation of the participant's body at the time the lab test was performed. Position of participant Supine after;Supine before;Standing Supine after;Supine before;Standing 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&deg;tilt, LBNP, and passive standing as measures of orthostatic tolerance. Aviat Space Environ Med 1975;46: 801-808 Adult;Pediatric Supplemental?Highly Recommended 1.00 2014-06-12 16:16:44.0 Passive Standing Test Protocol Autonomic Assessments and Examinations

Single Pre-Defined Value Selected

2008432
C19500 Assessment performed date AssessmentPerformedDate The date of assessment of the examination being performed. 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&deg;tilt, LBNP, and passive standing as measures of orthostatic tolerance. Aviat Space Environ Med 1975;46: 801-808 Adult;Pediatric Supplemental?Highly Recommended 1.00 2014-06-18 08:10:12.0 Passive Standing Test Protocol Autonomic Assessments and Examinations

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C19565 Blood Pressure measurement BldPressMeasr Blood pressure measurement with systolic measurement over diastolic measurement 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&deg;tilt, LBNP, and passive standing as measures of orthostatic tolerance. Aviat Space Environ Med 1975;46: 801-808 Adult;Pediatric Supplemental?Highly Recommended 1.00 2014-12-19 11:19:04.0 Passive Standing Test Protocol Autonomic Assessments and Examinations

Free-Form Entry

C58394 Position held minute text PosHeldMinTxt The time in minutes a position is held The time in minutes a position is held Minute 1 minute;2 minutes;3 minutes;4 minutes;5 Minutes;6 minutes;7 minutes;8 Minutes;9 minutes;10 minutes 1 minute;2 minutes;3 minutes;4 minutes;5 Minutes;6 minutes;7 minutes;8 Minutes;9 minutes;10 minutes 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&deg;tilt, LBNP, and passive standing as measures of orthostatic tolerance. Aviat Space Environ Med 1975;46: 801-808 Adult;Pediatric Supplemental?Highly Recommended 1.00 2018-02-08 15:21:44.0 Passive Standing Test Protocol Autonomic Assessments and Examinations

Single Pre-Defined Value Selected

CSV