CDE Detailed Report

Disease: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Sub-Domain: Post-Exertional Malaise
CRF: PEM-Focused Studies Questionnaire

Displaying 1 - 27 of 27
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
C57047 Post-exertional malaise termination stimulus indicator PEMTrmStmInd Indicator of who determined when the stimulus would be determined 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.

Adult Supplemental-Highly Recommended 1.00 2017-12-18 15:11:16.0 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 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.

Adult Supplemental-Highly Recommended 1.00 2017-12-20 11:55:19.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations 255

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C57048 Post-exertional malaise study participant determine termination criteria type PEMStdyPrtDtrmTrmCrtTyp Type of termination criteria that was determined based on the participant 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 Adult Supplemental-Highly Recommended 1.00 2017-12-19 10:20:34.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations

Single Pre-Defined Value Selected

C57059 Post-exertional malaise confounding activity indicator PEMCnfndActInd Indicator of if an objective method was used to measure confounding physical activity in this study 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? No;Yes No;Yes 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).

Adult Supplemental-Highly Recommended 1.00 2017-12-20 12:01:40.0 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 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 Adult Supplemental-Highly Recommended 1.00 2017-12-19 13:57:50.0 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 Name of the device used in measurement in PEM Device name Alphanumeric Adult Exploratory 1.00 2017-12-20 13:33:38.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations 255

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C14517 Device manufacturer name DevManufName The company responsible for development of the device The name of the manufacturer of the device that was placed in the subject's body Manufacturer Alphanumeric Adult Exploratory 3.00 2013-08-28 16:08:00.453 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations 255

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C57050 Post-exertional malaise maximum heart rate percentage value PEMMaxHrtRtPrcntVal Value of maximum heart rate percentage value Value of maximum heart rate percentage value % of maximum heart rate Numeric Values Adult Supplemental-Highly Recommended 1.00 2017-12-20 10:11:59.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations

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0 100
C57061 Post-exertional malaise model name PEMMdlName Name of model used in PEM study Name of model used in PEM study Model Alphanumeric Adult Exploratory 1.00 2017-12-20 13:50:51.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations 255

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C17402 Site name SiteName The name of the site for the study The name of the site for the study Site Name Alphanumeric Adult Supplemental 3.00 2013-06-21 00:00:00.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations 255

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C57051 Post-exertional malaise duration frequency related text PEMDurFrqRltTxt Text field related to the duration/frequency related termination Text field related to the duration/frequency related termination Duration/frequency-related Alphanumeric Adult Supplemental-Highly Recommended 1.00 2017-12-20 10:39:25.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations 255

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C57062 Post-exertional malaise measurement type PEMMeasrTyp Type of measurement in PEM study Type of measurement in PEM study What was measured (e.g. activity counts, pedometer steps, etc.) Alphanumeric Adult Exploratory 1.00 2017-12-21 09:44:30.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations 255

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C19247 Subject ID SubIDNam Subject identification ID Subject identification ID Subject ID Alphanumeric Adult Supplemental 1.00 2014-06-05 13:10:49.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations 255

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C57052 Post-exertional malaise stimulus relate text PEMStmRltTxt Text field related to stimulus-related termination Text field related to stimulus-related termination Stimulus-related (e.g. end of cognitive-fatiguing battery) Please specify Alphanumeric Adult Supplemental-Highly Recommended 1.00 2017-12-20 10:55:46.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations 255

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C57063 Post-exertional malaise activity start time PEMActvtyStrtTime Time at which the activity being measured started for the PEM study Time at which the activity being measured started for the PEM study Start time for measurement Date or Date & Time Adult Exploratory 1.00 2017-12-21 10:27:13.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations

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C57042 Post exertional malaise external stimulus induce type PEMPstExrtExtStmIndTyp Type of exertional stimulus that was used to induce PEM 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.

Adult Supplemental-Highly Recommended 1.00 2017-12-18 13:43:26.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations

Multiple Pre-Defined Values Selected

C57053 Post-exertional malaise symptom examine indicator PEMSympExmInd Indication of PEM symptoms being examined in this study 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? No;Yes No;Yes 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.

Adult Supplemental-Highly Recommended 1.00 2017-12-20 11:03:53.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations

Single Pre-Defined Value Selected

C57064 Post-exertional malaise activity end time PEMActvtyEndTime Time at which the activity being measured ended for the PEM study Time at which the activity being measured ended for the PEM study End time for measurement Date or Date & Time Adult Exploratory 1.00 2017-12-21 10:27:13.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations

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C57043 Post-exertional malaise determine stimulus research participant type PEMDetStimResPartTyp Indicator of whether the stimulus was researcher-applied/determined or study-participant-determined 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 Adult Supplemental-Highly Recommended 1.00 2017-12-18 13:58:05.0 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 Text field related to additional symptoms shownin PEM study If other symptoms were (also) assessed, please describe which ones Alphanumeric Adult Supplemental-Highly Recommended 1.00 2017-12-20 11:21:19.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations 255

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C57065 Post-exertional malaise activity duration PEMActvtyDur Duration of the activity being measured for the PEM study Duration of the activity being measured for the PEM study Duration of measurement (specify duration units (e.g. minutes or, how many days) out of a week, how many hours in a day, etc.) Numeric Values Adult Exploratory 1.00 2017-12-21 10:27:13.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations

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C57044 Post-exertional malaise researcher determine stimulus type description text PEMRsrDtrStmDscrTxt Free text field related to thedescription of the research applied determined stimulus type Free text field related to the description of the research applied determined stimulus type Type (e.g. treadmill, bicycle, cognitive-fatiguing activity) Alphanumeric Adult Supplemental-Highly Recommended 1.00 2017-12-18 14:36:27.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations 255

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C57055 Post-exertional malaise outcome measure time indicator PEMOtcmMeasrTimeInd Indication of timing of outcome measures in PEM study 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? No;Yes No;Yes 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.

Adult Supplemental-Highly Recommended 1.00 2017-12-20 11:31:23.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations

Single Pre-Defined Value Selected

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 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 Adult Supplemental-Highly Recommended 1.00 2017-12-18 14:36:27.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations 255

Free-Form Entry

C57056 Post-exertional malaise other time point outcome measure text PEMOthTimePntOtcmMeasrTxt Text field related to the other time points in which outcomes were measured Text field related to the other time points in which outcomes were measured At what other time points were outcomes measured? Alphanumeric Adult Supplemental-Highly Recommended 1.00 2017-12-20 11:44:48.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations 255

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C57046 Post-exertional malaise study participant determine stimulus measurement type PEMStdyPrtDtrmStmMeasrTyp Type or description of how the study participant determined stimulus was measured 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 Adult Supplemental-Highly Recommended 1.00 2017-12-18 14:59:51.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations

Single Pre-Defined Value Selected

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 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)? No;Yes No;Yes 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.

Adult Supplemental-Highly Recommended 1.00 2017-12-20 11:47:07.0 PEM-Focused Studies Questionnaire Post-Exertional Malaise Assessments and Examinations

Single Pre-Defined Value Selected

CSV