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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: Post-Exertional Malaise
CRF: PEM-Focused Studies Questionnaire
Item count: 27 (27 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
C17402
Site name
SiteName
The name of the site for the study
Site Name
  
Alphanumeric
No instructions available
No references available
Adult
Supplemental
3.0
6/21/2013
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
Site name
255
Free-Form Entry
       
C19247
Subject ID
SubIDNam
Subject identification ID
Subject ID
  
Alphanumeric
No instructions available
No references available
Adult
Supplemental
1.0
6/5/2014
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
 
255
Free-Form Entry
       
C57042
Post exertional malaise external stimulus induce type
PEMPstExrtExtStmIndTyp
Type of exertional stimulus that was used to induce PEM
Describe the exertional stimulus used to induce PEM. Check all answers that apply.
Physical exertion;Cognitive exertion;Orthostatic;Other, specify;
Physical exertion;Cognitive exertion;Orthostatic;Other, specify;
Alphanumeric
"Researcher-applied stimuli" refers to stimuli that are not usually a part of a study participant's daily activities, e.g. treatdmill testing, neuropsychological batteries meant to induce cognitive fatigue, bicycle ergometers. "Study-participant-determined stimuli" refers to activities that participants usually engage in e.g. walking, driving, household chores, etc.
No references available
Adult
Supplemental–Highly Recommended
1.0
12/18/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
  
Multiple Pre-Defined Values Selected
       
C57043
Post-exertional malaise determine stimulus research participant type
PEMDetStimResPartTyp
Indicator of whether the stimulus was researcher-applied/determined or study-participant-determined
Was stimulus researcher-applied/determined or study-participant-determined (i.e. spontaneous/free activity)
Researcher;Study Participant;Both;Neither;
Researcher;Study Participant;Both;Neither;
Alphanumeric
No instructions available
No references available
Adult
Supplemental–Highly Recommended
1.0
12/18/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C57044
Post-exertional malaise researcher determine stimulus type description text
PEMRsrDtrStmDscrTxt
Free text field related to thedescription of the research applied determined stimulus type
Type (e.g. treadmill, bicycle, cognitive-fatiguing activity)
  
Alphanumeric
No instructions available
No references available
Adult
Supplemental–Highly Recommended
1.0
12/18/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
 
255
Free-Form Entry
       
C57045
Post-exertional malaise researcher determine stimulus protocol description text
PEMRsrDtrStmPrtDscrTxt
Free text field related to the description of the research applied determined stimulus protocol
Protocol for stimulus (e.g. Bruce protocol for treadmill; intensity, frequency, duration)
  
Alphanumeric
No instructions available
No references available
Adult
Supplemental–Highly Recommended
1.0
12/18/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
 
255
Free-Form Entry
       
C57046
Post-exertional malaise study participant determine stimulus measurement type
PEMStdyPrtDtrmStmMeasrTyp
Type or description of how the study participant determined stimulus was measured
For study-participant-determined stimulus , please describe how stimulus was measured or characterized (e.g. pedometer steps, activity diary, etc.):
Activity Diary;Activity Questionnaire;Monitoring Device (e.g. pedometer, FitBit);Other, specify;
Activity Diary;Activity Questionnaire;Monitoring Device (e.g. pedometer, FitBit);Other method, specify;
Alphanumeric
No instructions available
No references available
Adult
Supplemental–Highly Recommended
1.0
12/18/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C57047
Post-exertional malaise termination stimulus indicator
PEMTrmStmInd
Indicator of who determined when the stimulus would be determined
Who determined when stimulus would be terminated?
Researcher;Study Participant;Both;Neither;
Researcher;Study Participant;Both;Neither;
Alphanumeric
For researcher-applied stimuli, termination may be decided entirely by the researcher (e.g. 70% of maximum heart rate), entirely by the participants (e.g. volitional fatigue), or by a combination of criteria (e.g. 70% of maximum heart rate or volitional fatigue, whichever endpoint arrives earlier). In the latter case, researchers should check the "both category for 2a. And describe the criteria in items 2b. And 2c. For study-participant-determined stimuli, researchers have often decided to record activity for a pre-planned time period (e.g. 3 days) and assess activity performed during this time on PEM symptoms. We have left text boxes in anticipation that a variety of study designs may be employed.
No references available
Adult
Supplemental–Highly Recommended
1.0
12/18/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C57048
Post-exertional malaise study participant determine termination criteria type
PEMStdyPrtDtrmTrmCrtTyp
Type of termination criteria that was determined based on the participant
Study participant-determined criteria:
Stimulus continued until study participant decided to or asked to stop;Based on study-participant symptoms;Other,specify;
Stimulus continued until study participant decided to or asked to stop;Based on study-participant symptoms;Other, specify;
Alphanumeric
No instructions available
No references available
Adult
Supplemental–Highly Recommended
1.0
12/19/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C57049
Post-exertional malaise researcher determine termination type
PEMRsrDtrmTrmTyp
Type of researcher determined termination
Researcher-determined criteria
Heart-rate related: to ___% of maximum heart rate (define how this was determined);Respiratory equivalent ratio (RER) equal to or greater than 1;Duration/frequency-related;Stimulus-related (e.g. end of cognitive-fatiguing battery);Other,specify;
Heart-rate related: to ___% of maximum heart rate (define how this was determined);Respiratory equivalent ratio (RER) equal to or greater than 1;Duration/frequency-related;Stimulus-related (e.g. end of cognitive-fatiguing battery);Other, specify;
Alphanumeric
No instructions available
No references available
Adult
Supplemental–Highly Recommended
1.0
12/19/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C57050
Post-exertional malaise maximum heart rate percentage value
PEMMaxHrtRtPrcntVal
Value of maximum heart rate percentage value
% of maximum heart rate
  
Numeric Values
No instructions available
No references available
Adult
Supplemental–Highly Recommended
1.0
12/20/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
  
Free-Form Entry
0
100
     
C57051
Post-exertional malaise duration frequency related text
PEMDurFrqRltTxt
Text field related to the duration/frequency related termination
Duration/frequency-related
  
Alphanumeric
No instructions available
No references available
Adult
Supplemental–Highly Recommended
1.0
12/20/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
 
255
Free-Form Entry
       
C57052
Post-exertional malaise stimulus relate text
PEMStmRltTxt
Text field related to stimulus-related termination
Stimulus-related (e.g. end of cognitive-fatiguing battery) Please specify
  
Alphanumeric
No instructions available
No references available
Adult
Supplemental–Highly Recommended
1.0
12/20/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
 
255
Free-Form Entry
       
C57053
Post-exertional malaise symptom examine indicator
PEMSympExmInd
Indication of PEM symptoms being examined in this study
Were all of the symptoms of physical fatigue, unrefreshing sleep, muscle pain, and problems of concentration and memory examined in this study?
Yes;No;
Yes;No;
Alphanumeric
Since PEM is an exacerbation of multiple symptoms, researchers should examine at least physical fatigue, unrefreshing sleep, muscle pain, and problems of concentration and memory. Researchers are also encouraged to study additional symptoms.
No references available
Adult
Supplemental–Highly Recommended
1.0
12/20/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C57054
Post-exertional malaise additional symptom text
PEMAddSymTxt
Text field related to additional symptoms shownin PEM study
If other symptoms were (also) assessed, please describe which ones
  
Alphanumeric
No instructions available
No references available
Adult
Supplemental–Highly Recommended
1.0
12/20/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
 
255
Free-Form Entry
       
C57055
Post-exertional malaise outcome measure time indicator
PEMOtcmMeasrTimeInd
Indication of timing of outcome measures in PEM study
Were outcomes measured before, immediately after, 24 hours after, and 7 days after an applied stimulus or after an observational study began?
Yes;No;
Yes;No;
Alphanumeric
Post-exertional symptoms can start during, immediately after, or hours-days after exposure to a trigger and can last hours, days, weeks, or even months. Change in activity or function follows a similar time course. Timing of outcome measures need to reflect what is known about PEM timing. Most past research has concentrated primareily on the time period hours or up to 3 days after a PEM-inducing trigger. Outcomes should be measured at the very least at baseline (time point 0, before the stimulus is applied), immediately after, at 24 hours after, and at 7 days after the applied stimulus or after the study has started for participant-determined stimuli. We also suggest a time-point past 7 days to capture episodes of long-lasting PEM. Researchers are encouraged to include other time periods in additional to the suggested times.
No references available
Adult
Supplemental–Highly Recommended
1.0
12/20/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C57056
Post-exertional malaise other time point outcome measure text
PEMOthTimePntOtcmMeasrTxt
Text field related to the other time points in which outcomes were measured
At what other time points were outcomes measured?
  
Alphanumeric
No instructions available
No references available
Adult
Supplemental–Highly Recommended
1.0
12/20/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
 
255
Free-Form Entry
       
C57057
Post-exertional malaise correlation objective outcome subjective measure indicator
PEMCrrObjOtcmSbjMeasInd
Indicator of whether objective outcome measures were around the same time as subjective outcome measures
Were objective outcome measures measured at or aroumd the same time as subjective outcome measures (e.g. patient-reported outcome measures)?
Yes;No;
Yes;No;
Alphanumeric
There s an urgent need for studies where objective outcome measures for studies where objective outcome measures are studied in conjunction with post-exertional symptoms and change in function/level of activity. Without this type of study design, it is hard to interpret results within the context of a participant's condition. If some objectives outcome measures were correlated with subjective measures while others were not, please check "No" and provide an answer why this was not done.
No references available
Adult
Supplemental–Highly Recommended
1.0
12/20/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C57058
Post-exertional malaise outcome measure type
PEMOtcmMeasrTyp
Type of PEM outcome measurements within this study
What were the outcome measures in this study?
  
Alphanumeric
Outcome measures may be study participant self-reported questionnaires, clinician/researcher assessments, biomarkers, or a combination of these. Researcher should list the names of standardized instruments use (e.g. Fatigue Severity Scale, DePaul Symptom Questionnaire), the type of biomarder (e.g. cytokine levels, functional MRI), and/or describe the outcome measure in a manner that other can replicate it.
No references available
Adult
Supplemental–Highly Recommended
1.0
12/20/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
 
255
Free-Form Entry
       
C57059
Post-exertional malaise confounding activity indicator
PEMCnfndActInd
Indicator of if an objective method was used to measure confounding physical activity in this study
Was an objective method used to measure confounding physical activity in this study at any time?
Yes;No;
Yes;No;
Alphanumeric
Confounding activity is activity spontaneously engaged in by study participants and not intentionally meant to induce PEM. Because PEM can be delayed and prolonged, accounting for activity before, during and sometimes after the planned stimulus is important. In a study with researcher-applied stimuli, confounding activity is activity prior to and/or during the stimuli (e.g. for 2-day cardiopulmonary exercise testing (C{ET), activity conducted after the first CPET but before the second CPET is confounding activity). In a study with study-participant-determined stimuli, confounding activity is activity performed prior to when researchers start recording study-participant-determined activity or during times when activity is not being recorded (e.g. if activity is recorded for only 10 hours a day, activity performed during the remaining 14 hours is counfounding activity). In some cases, if there is a lag time between the stimuli and measurement of an outcome measure (e.g. blood draw 2 days after a treadmill test or after activity recording has stopped), intervening activity performed after the stimuli may also be confounding activity.

If a physical activity monitor was employed, please see the Exploratory Outcome Measures: Physical Activity table for more details/guidelines and consider completing items 7a, 7b, 7c. Objective measures of physical activity are impacted by the equipment used, the types of measurements taken, when activity is measured, and the duration of measurement. Consequently, researchers are encouaged to provide this information in the CRF.
If a physical activity monitor was employed, please see the Exploratory Outcome Measures: Physical Activity table for more details/guidelines and consider completing items 7a, 7b, and 7c. Objective measures of physical activity are impacted by the equipment used, the types of measurements taken, when activity is measure, and the duration of measurement. Consequently, researchers are encouraged to provide this information in the CRF.

For item 7c., "Start time" and "End time" refer to the first/last date and time that physical activity monitoring began and ended, respectively. For studies where physical activity monitors were used intermittently, researchers should also complete item 7c (iii), specifying the planned duration of monitoring (e.g. 10 hours a day for 3 days, before and for the 24 hours between 2 exercise tests).
No references available
Adult
Supplemental–Highly Recommended
1.0
12/20/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C57060
Post-exertional malaise device name
PEMDvcName
Name of the device used in measurement in PEM
Device name
  
Alphanumeric
No instructions available
No references available
Adult
Exploratory
1.0
12/20/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
 
255
Free-Form Entry
       
C14517
Device manufacturer name
DevManufName
The company responsible for development of the device
Manufacturer
  
Alphanumeric
No instructions available
No references available
Adult
Exploratory
3.0
8/28/2013
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
Device manufacturer name
255
Free-Form Entry
       
C57061
Post-exertional malaise model name
PEMMdlName
Name of model used in PEM study
Model
  
Alphanumeric
No instructions available
No references available
Adult
Exploratory
1.0
12/20/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
 
255
Free-Form Entry
       
C57062
Post-exertional malaise measurement type
PEMMeasrTyp
Type of measurement in PEM study
What was measured (e.g. activity counts, pedometer steps, etc.)
  
Alphanumeric
No instructions available
No references available
Adult
Exploratory
1.0
12/21/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
 
255
Free-Form Entry
       
C57063
Post-exertional malaise activity start time
PEMActvtyStrtTime
Time at which the activity being measured started for the PEM study
Start time for measurement
  
Date or Date & Time
No instructions available
No references available
Adult
Exploratory
1.0
12/21/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
  
Free-Form Entry
       
C57064
Post-exertional malaise activity end time
PEMActvtyEndTime
Time at which the activity being measured ended for the PEM study
End time for measurement
  
Date or Date & Time
No instructions available
No references available
Adult
Exploratory
1.0
12/21/2017
Aliases for variable name not defined
PEM-Focused Studies Questionnaire
Post-Exertional Malaise
Assessments and Examinations
  
Free-Form Entry
       
12-14-2018
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