CDE Detailed Report | NINDS Common Data Elements

Disease: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Subdomain Name: Autonomic
CRF: Passive Standing Test Protocol

Displaying 1 - 7 of 7

CDE ID	CDE Name	Variable Name	Definition	Short Description	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 / Guidance)	Subdomain Name	Domain Name	Size	Input Restrictions	Min Value	Max Value	Measurement Type	External Id caDSR
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°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 performe	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°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°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		Free-Form Entry
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°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°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
C01521	Heart rate	HeartRate	The participant's pulse or number of contractions (heart beats) per minute	The participant'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	3.10	2024-03-11 10:48:30.0	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 administere	List medications taken in last 2 weeks			Alphanumeric		References<br />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	4000	Free-Form Entry				3162728