SDTM QS

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.QS is designed for capturing the patients’ questions info.

Definition:

QS domain is a questionaries domain that contains a variety of patient information 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 from SDTM.QS to ADaM.ADQS, the biggest challenge is constructing the variable AVAL for analysis value. Some questionnaires scores need to meet Consecutive 5 out of 7 days in order for the score to be documented. We will demonstrate how to compose a Marco to Count Consecutive Records in 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”

 

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