CDE Detailed Report

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

Displaying 1 - 15 of 15
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
C19247 Subject ID SubIDNam Subject identification ID Subject identification ID Subject ID Alphanumeric Adult Core 1.00 2014-06-05 13:10:49.0 Core PEM Assessment Questionnaire Post-Exertional Malaise Assessments and Examinations 255

Free-Form Entry

C57098 DePaul Symptom Questionnaire (DSQ) - minimum exercise physical tired severity scale DSQMnExPhyTrdSvScl Scale related to the severity of the individual feeling as if minimum exercise makes him/her physically tired, as part of the DePaul Symptom Questionnaire (DSQ) Scale related to the severity of the individual feeling as if minimum exercise makes him/her physically tired, as part of the DePaul Symptom Questionnaire (DSQ) Minimum exercise makes you physically tired (Severity) 1;2;3;4 Mild;Moderate;Severe;Very severe Numeric Values Adult Core 1.00 2017-12-27 14:07:18.0 Core PEM Assessment Questionnaire Post-Exertional Malaise Assessments and Examinations

Single Pre-Defined Value Selected

C57069 Post-exertional malaise DePaul Symptom Questionnaire threshold met indicator PEMDSQThrshldMtInd Indicator of whether DSQ PEM threshold was met Indicator of whether DSQ PEM threshold was met Was the DSQ PEM Threshold met? No;Yes No;Yes Alphanumeric

Guidance on "PEM Determination Method:" The standard method for evaluating the "Global PEM Determination" is a two step process in which the study participant responds to the DSQ PEM questions and the researcher then evaluates those responses in light of other information about the study participant to determine whether the study participant has PEM or not. In making this determination, the researcher or clinician will need to consider whether there are other conditions, such as overwork, that could result in a false positive DSQ PEM subscale response. On the other hand, the researcher or clinican should also consider whether the study participant responded negatively because, for instance, they carefully manage their energy expenditures with pacing to avoid episodes of PEM. In addition to asking questions about workload and pacing, the researcher may also ask what happens to the study participant if/when they engage in physical or mental activity and whether there are activities they avoid because it exacerbates symptoms. In addition to their own examination of the study participant, the researcher may also consider information from other sources like medial records but these should be carefully considered, as they might not reflect an accurate understanding of the nature of PEM.

While the above method should be used in all studies, there may be certain types of studies, such as patient surveys or studies of existing samples in which it is not possible to use this two-step method. In those limited instances, the researcher may be able to use information from other sources, such as patient reports and medical records as the basis of the Global PEM Determination. These other choices, particularly self-report and resports by other medical providers, are not recommended because these reports by other medical providers, are not recommended because these reports of PEM have not been verified.

Adult Core 1.00 2017-12-21 12:24:48.0 Core PEM Assessment Questionnaire Post-Exertional Malaise Assessments and Examinations

Single Pre-Defined Value Selected

C57099 DePaul Symptom Questionnaire (DSQ) - Physical drain after mild activity frequency scale DSQPhysDrnAftrMldActFreqScl Frequency of how often an individual feels physically drained or sick after mild activity, as part of the DePaul Symptom Questionnaire (DSQ) Frequency of how often an individual feels physically drained or sick after mild activity, as part of the DePaul Symptom Questionnaire (DSQ) Physically drained or sick after mild activity (Frequency) 0;1;2;3;4 None of the time;A little of the time;About half the time;Most of the time;All of the time Numeric Values Adult Core 1.00 2017-12-27 14:03:23.0 Core PEM Assessment Questionnaire Post-Exertional Malaise Assessments and Examinations

Single Pre-Defined Value Selected

C57070 Post-exertional malaise diagnosis method type PEMDiagMthdTyp Type of method used to determine whether PEM is experienced Type of method used to determine whether PEM is experienced What method was used to determine whether the study participant experiences PEM? (Please check all answers that apply) The 2-step DSQ PEM/researcher evaluation process (recommended);Previously reported by a ME/CFS specialist;Previously reported by other medical provider who is not an ME/CFS specialist;Patient-reported- using DSQ PEM questions;Patient-reported- other sources;Other, specify The 2-step DSQ PEM/researcher evaluation process (recommended);Previously reported by a ME/CFS specialist;Previously reported by other medical provider who is not an ME/CFS specialist;Patient-reported- using DSQ PEM questions;Patient-reported- other sources;Other, specify Alphanumeric

The following choices are provided to capture the method used to determine PEM:
• The 2-step DSQ PEM/researcher evaluation process (recommended)
• Previously reported by ME/CFS Specialist
• Previously reported by other Medical Provider who is not an ME/CFS specialist
•Patient reported- using DSQ PEM questions
•Patient-reported- other sources
•Other, specify
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Multiple choices can be selected if appropriate. The first choice should only be selected when the two-step process described above is used.

Adult Core 1.00 2017-12-27 09:07:11.0 Core PEM Assessment Questionnaire Post-Exertional Malaise Assessments and Examinations

Multiple Pre-Defined Values Selected

C57100 DePaul Symptom Questionnaire (DSQ) - physical drain after mild activity severity scale DSQPhyDrnAftMldActSvScl Scale related to the severity of the individual feeling physically drained or sick after mild activity, as part of the DePaul Symptom Questionnaire (DSQ) Scale related to the severity of the individual feeling physically drained or sick after mild activity, as part of the DePaul Symptom Questionnaire (DSQ) Physically drained or sick after mild activity (Severity) 1;2;3;4 Mild;Moderate;Severe;Very severe Numeric Values Adult Core 1.00 2017-12-27 14:07:18.0 Core PEM Assessment Questionnaire Post-Exertional Malaise Assessments and Examinations

Single Pre-Defined Value Selected

C57071 Post-exertional malaise experience indicator PEMExprInd Indicator of whether study participant experiences PEM Indicator of whether study participant experiences PEM Does the study participant experience PEM? No;Yes;Inconclusive;Not Evaluated No;Yes;Inconclusive;Not Evaluated Alphanumeric

Guidance on "Global PEM Determination: Regardless of the method used as described in the previous section, the presence of absence of PEM is captured in this field using one of the following choices:
•Yes
•No
•Inconclusive
•Not Evaluated

Adult Core 1.00 2017-12-27 09:19:28.0 Core PEM Assessment Questionnaire Post-Exertional Malaise Assessments and Examinations

Single Pre-Defined Value Selected

C57091 DePaul Symptom Questionnaire (DSQ) - Dead heavy feeling after exercise frequency scale DSQDdHvyFlngAfExFreqScl Frequency of how often an individual has a dead, heavy feeling after starting to exercise, as part of the DePaul Symptom Questionnaire (DSQ) Frequency of how often an individual has a dead, heavy feeling after starting to exercise, as part of the DePaul Symptom Questionnaire (DSQ) Dead, heavy feeling after starting to exercise (Frequency) 0;1;2;3;4 None of the time;A little of the time;About half the time;Most of the time;All of the time Numeric Values Adult Core 1.00 2017-12-27 14:03:23.0 Core PEM Assessment Questionnaire Post-Exertional Malaise Assessments and Examinations

Single Pre-Defined Value Selected

C57092 DePaul Symptom Questionnaire (DSQ) - dead heavy feeling after exercise severity scale DSQDdHvyFlngAftExSvScl Scale related to the severity of the individual having a dead, heavy feeling after starting to exercise, as part of the DePaul Symptom Questionnaire (DSQ) Scale related to the severity of the individual having a dead, heavy feeling after starting to exercise, as part of the DePaul Symptom Questionnaire (DSQ) Dead, heavy feeling after starting to exercise (Severity) 1;2;3;4 Mild;Moderate;Severe;Very severe Numeric Values Adult Core 1.00 2017-12-27 14:07:18.0 Core PEM Assessment Questionnaire Post-Exertional Malaise Assessments and Examinations

Single Pre-Defined Value Selected

C57093 DePaul Symptom Questionnaire (DSQ) - Soreness next day frequency scale DSQSrnssNxtDyFreqScl Frequency of how often an individual has next day soreness or fatigue after non-strenuous, everyday activities, as part of the DePaul Symptom Questionnaire (DSQ) Frequency of how often an individual has next day soreness or fatigue after non-strenuous, everyday activities, as part of the DePaul Symptom Questionnaire (DSQ) Next day soreness or fatigue after non-strenuous, everyday activities (Frequency) 0;1;2;3;4 None of the time;A little of the time;About half the time;Most of the time;All of the time Numeric Values Adult Core 1.00 2017-12-27 14:03:23.0 Core PEM Assessment Questionnaire Post-Exertional Malaise Assessments and Examinations

Single Pre-Defined Value Selected

C57094 DePaul Symptom Questionnaire (DSQ) - Soreness next day severity scale DSQSrnssNxtDySvScl Scale related to the severity of the individual having next day soreness or fatigue after non-strenuous, everyday activities, as part of the DePaul Symptom Questionnaire (DSQ) Scale related to the severity of the individual having next day soreness or fatigue after non-strenuous, everyday activities, as part of the DePaul Symptom Questionnaire (DSQ) Next day soreness or fatigue after non-strenuous, everyday activities (Severity) 1;2;3;4 Mild;Moderate;Severe;Very severe Numeric Values Adult Core 1.00 2017-12-27 14:07:18.0 Core PEM Assessment Questionnaire Post-Exertional Malaise Assessments and Examinations

Single Pre-Defined Value Selected

C57095 DePaul Symptom Questionnaire (DSQ) - Mentally tired after slight effort frequency scale DSQMntlTrAftrSlghtEffFreqScl Frequency of how often an individual feels mentally tired after slightest effort, as part of the DePaul Symptom Questionnaire (DSQ) Frequency of how often an individual feels mentally tired after slightest effort, as part of the DePaul Symptom Questionnaire (DSQ) Mentally tired after the slightest effort (Frequency) 0;1;2;3;4 None of the time;A little of the time;About half the time;Most of the time;All of the time Numeric Values Adult Core 1.00 2017-12-27 14:03:23.0 Core PEM Assessment Questionnaire Post-Exertional Malaise Assessments and Examinations

Single Pre-Defined Value Selected

C57096 DePaul Symptom Questionnaire (DSQ) - mentally tired after slight effort severity scale DSQMntlTrAftSlgEffSvScl Scale related to the severity of the individual feeling mentally tired after the slightest effort, as part of the DePaul Symptom Questionnaire (DSQ) Scale related to the severity of the individual feeling mentally tired after the slightest effort, as part of the DePaul Symptom Questionnaire (DSQ) Mentally tired after the slightest effort (Severity) 1;2;3;4 Mild;Moderate;Severe;Very severe Numeric Values Adult Core 1.00 2017-12-27 14:07:18.0 Core PEM Assessment Questionnaire Post-Exertional Malaise Assessments and Examinations

Single Pre-Defined Value Selected

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

Free-Form Entry

C57097 DePaul Symptom Questionnaire (DSQ) - Minimum exercise make physical tired frequency scale DSQMnExMkPhysTrFreqScl Frequency of how often an individual feels as if minimum exercise makes him/her physically tired, as part of the DePaul Symptom Questionnaire (DSQ) Frequency of how often an individual feels as if minimum exercise makes him/her physically tired, as part of the DePaul Symptom Questionnaire (DSQ) Minimum exercise makes you physically tired (Frequency) 0;1;2;3;4 None of the time;A little of the time;About half the time;Most of the time;All of the time Numeric Values Adult Core 1.00 2017-12-27 14:03:23.0 Core PEM Assessment Questionnaire Post-Exertional Malaise Assessments and Examinations

Single Pre-Defined Value Selected

CSV