SDTM Day 2: QS
Background:
As the novice treatments for Cancer therapy have been developed, not only we care about prolonging the lives of patients, scientists also put their endeavor to improve the life qualities.SDTM.QSis designed for capturing the patients' questions info.
Definition:
QSdomain is a questionaries domain that contains a variety of patientinformation about different questionnaires. Such as Quality of Life, Mental Health, Disease Activity.
Popular Questionnaires:
EOL5:quality of life 5 questions
SF12:Fatigue Severity Scale 12 questions
MPN-SAF:Myeloproliferative Neoplasm Symptom Assessment
SDTM.QS Domain:
Key variables For SDTM.QS:
USUBJID, QSCAT, QSTEST, QSTESTCD, QSDTC, QSORRES, QSBLFL, QSDY
Usubjid:Identify the patient info
E.g. TF-001-001, TF-001-002,..
Qscat:Category of Questions
E.g. EURO QOL-5 DIMENSIONS, MF-SAF FATIGUE
Qstestcd:Question Code,Qstestcd ∈ Qscat
E.g. EQ5D01, EQ5D02,..
Qstest:Question Name
E.g. Mobility, Self care, Usual activities, Pain discomfort, Anxiety depression
Qsstresn:Numerical score for questions
E.g. 1,2,3,4,5
Qsdtc:Questionnaire date
E.g. 2012-04-29
Qsorres:Original Score for questions
E.g. 1,2,3,4,5
Visit:Visit name
E.g. Screening, Cycle1 Day 1, End of Treatment, Follow Up...
Qsblfl:Baseline Flage
E.g. Y, N
Logic: Last non-missing assessment Before or ON treatment start day
Qsdy:Study Day of Finding
E.g. -3,1,100
Logic: Qsdtc - Treatment Start Day +1
Sample SDTM.QS Dataset:
Note: the sample QS dataset Qsstresn is created with SAS rand function, and QSDTC is a dummy date.
Potential Challenges:
When we move fromSDTM.QStoADaM.ADQS, the biggest challenge is constructing the variableAVALfor analysis value. Some questionnaires scores need to meetConsecutive 5 out of 7 daysin order for the score to be documented. We will demonstrate how to compose aMarco to Count Consecutive Recordsin the future.
Happy Studying!😸
Additional Info:
"FATIGUE RIGHT NOW"="MPNSAF01"
"USUAL LEVEL OF FATIGUE"="MPNSAF02"
"WORST LEVEL OF FATIGUE"="MPNSAF03"
"GENERAL ACTIVITY"="MPNSAF04"
"MOOD"="MPNSAF05"
"WALKING ABILITY"="MPNSAF06"
"NORMAL WORK"="MPNSAF07"
"RELATIONS"="MPNSAF08"
"ENJOYMENT OF LIFE"="MPNSAF09"
"FILLING UP QUICKLY WHEN YOU EAT"="MPNSAF10"
"ABDOMINAL PAIN"="MPNSAF11"
"ABDOMINAL DISCOMFORT"="MPNSAF12"
"INACTIVITY"="MPNSAF13"
"PROBLEMS WITH HEADACHES"="MPNSAF14"
"PROBLEMS WITH CONCENTRATION"="MPNSAF15"
"DIZZINESS/VERTIGO/LIGHTHEADEDNESS"="MPNSAF16"
"NUMBNESS/TINGLING"="MPNSAF17"
"DIFFICULTY SLEEPING"="MPNSAF18"
"DEPRESSION OR SAD MOOD"="MPNSAF19"
"PROBLEMS WITH SEXUAL DESIRE OR FUNCTION"="MPNSAF20"
"COUGH"="MPNSAF21"
"NIGHT SWEATS"="MPNSAF22"
"ITCHING"="MPNSAF23"
"BONE PAIN"="MPNSAF24"
"FEVER"="MPNSAF25"
"UNINTENTIONAL WEIGHT LOSS LAST 6 MONTHS"="MPNSAF26"
"OVERALL QUALITY OF LIFE"="MPNSAF27"
