CDE Detailed Report

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."

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.

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.).