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Forms in QS (5)

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EQ-5D-3L

Sources: DB1, SDTM | Forms loaded: 5

QS (Questionnaires)

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#	Question	Response / annotation
1	Date Collected eq5d3l.DT_RAW	QSDTC
2	Performed? eq5d3l.STAT	Yes [NOT SUBMITTED] No QSSTAT = NOT DONE when QSTESTCD = QSALL
3	Reason if not performed eq5d3l.REASND	QSREASND
4	Mobility eq5d3l.EQ5D01	I have no problems in walking about I have some problems in walking about I am confined to bed QSORRES when QSTESTCD = EQ5D101
5	Self-care eq5d3l.EQ5D02	I have no problems with self-care I have some problems washing or dressing myself I am unable to wash or dress myself QSORRES when QSTESTCD = EQ5D102
6	Usual activities eq5d3l.EQ5D03	I have no problems with performing my usual activities I have some problems with performing my usual activities I am unable to perform my usual activities QSORRES when QSTESTCD = EQ5D103
7	Pain/Discomfort eq5d3l.EQ5D04	I have no pain or discomfort I have moderate pain or discomfort I have extreme pain or discomfort QSORRES when QSTESTCD = EQ5D104
8	Anxiety/Depression eq5d3l.EQ5D05	I am not anxious or depressed I am moderately anxious or depressed I am extremely anxious or depressed QSORRES when QSTESTCD = EQ5D105
9	Health state Visual Analog Score eq5d3l.EQ5D06	QSORRES when QSTESTCD = EQ5D106

EQ-5D-5L

Sources: DB1, SDTM | Forms loaded: 5

QS (Questionnaires)

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#	Question	Response / annotation
1	Date Collected eq5d5l.DT_RAW	QSDTC
2	Performed? eq5d5l.STAT	Yes [NOT SUBMITTED] No QSSTAT = NOT DONE when QSTESTCD = QSALL
3	Reason if not performed eq5d5l.REASND	QSREASND
4	Mobility eq5d5l.EQ5D01	I have no problems walking I have slight problems walking I have moderate problems walking I have severe problems walking I am unable to walk QSORRES when QSTESTCD = EQ5D201
5	Self-care eq5d5l.EQ5D02	I have no problems washing or dressing myself I have slight problems washing or dressing myself I have moderate problems washing or dressing myself I have severe problems washing or dressing myself I am unable to wash or dress myself QSORRES when QSTESTCD = EQ5D202
6	Usual activities eq5d5l.EQ5D03	I have no problems doing my usual activities I have slight problems doing my usual activities I have moderate problems doing my usual activities I have severe problems doing my usual activities I am unable to do my usual activities QSORRES when QSTESTCD = EQ5D203
7	Pain/Discomfort eq5d5l.EQ5D04	I have no pain or discomfort I have slight pain or discomfort I have moderate pain or discomfort I have severe pain or discomfort I have extreme pain or discomfort QSORRES when QSTESTCD = EQ5D204
8	Anxiety/Depression eq5d5l.EQ5D05	I am not anxious or depressed I am slightly anxious or depressed I am moderately anxious or depressed I am severely anxious or depressed I am extremely anxious or depressed QSORRES when QSTESTCD = EQ5D205
9	Health state Visual Analog Score eq5d5l.EQ5D06	QSORRES when QSTESTCD = EQ5D206

Health Assessment Questionnaire - Disability Index

Sources: DB1, SDTM | Forms loaded: 5

QS (Questionnaires)

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#	Question	Response / annotation
1	Date of assessment field_001	QSDTC
2	Dressing & Grooming field_002
3	Dress yourself, including tying shoelaces and doing buttons? field_003	Without ANY difficulty With SOME difficulty With MUCH difficulty UNABLE to do QSORRES when QSTESTCD = HAQ0101
4	Shampoo your hair? field_004	Without ANY difficulty With SOME difficulty With MUCH difficulty UNABLE to do QSORRES when QSTESTCD = HAQ0102
5	Arising field_005
6	Stand up from an armless chair? field_006	Without ANY difficulty With SOME difficulty With MUCH difficulty UNABLE to do QSORRES when QSTESTCD = HAQ0103
7	Get in and out of bed? field_007	Without ANY difficulty With SOME difficulty With MUCH difficulty UNABLE to do QSORRES when QSTESTCD = HAQ0104
8	Eating field_008
9	Cut up your own meat? field_009	Without ANY difficulty With SOME difficulty With MUCH difficulty UNABLE to do QSORRES when QSTESTCD = HAQ0105
10	Lift a full cup or glass to your mouth? field_010	Without ANY difficulty With SOME difficulty With MUCH difficulty UNABLE to do QSORRES when QSTESTCD = HAQ0106
11	Open a new carton of milk (or soap powder)? field_011	Without ANY difficulty With SOME difficulty With MUCH difficulty UNABLE to do QSORRES when QSTESTCD = HAQ0107
12	Walking field_012
13	Walk outdoors on flat ground? field_013	Without ANY difficulty With SOME difficulty With MUCH difficulty UNABLE to do QSORRES when QSTESTCD = HAQ0108
14	Climb up five steps? field_014	Without ANY difficulty With SOME difficulty With MUCH difficulty UNABLE to do QSORRES when QSTESTCD = HAQ0109
15	AIDS or DEVICES that you usually use for any of the preceding activities: field_015
16	Devices used for Dressing (button hook, zipper pull, shoe horn)? field_016	Yes No QSORRES when QSTESTCD = HAQ0114
17	Cane (W) field_017	Yes No QSORRES when QSTESTCD = HAQ0110
18	Walking Frame (W) field_018	Yes No QSORRES when QSTESTCD = HAQ0111
19	Crutches (W) field_019	Yes No QSORRES when QSTESTCD = HAQ0112
20	Wheel Chair (W) field_020	Yes No QSORRES when QSTESTCD = HAQ0113
21	Special or built up chair (A) field_021	Yes No QSORRES when QSTESTCD = HAQ0116
22	Built up or special utensils (E) field_022	Yes No QSORRES when QSTESTCD = HAQ0115
23	Any other devices used? field_023	Yes No QSORRES when QSTESTCD = HAQ0117
24	Specify if any other device is used field_024	QSORRES when QSTESTCD = HAQ0118
25	Any categories for which help is needed from another person field_025
26	Dressing and Grooming field_026	Yes No QSORRES when QSTESTCD = HAQ0119
27	Arising field_027	Yes No QSORRES when QSTESTCD = HAQ0120
28	Eating field_028	Yes No QSORRES when QSTESTCD = HAQ0121
29	Walking field_029	Yes No QSORRES when QSTESTCD = HAQ0122
30	Hygiene field_030
31	Wash and dry your entire body? field_031	Without ANY difficulty With SOME difficulty With MUCH difficulty UNABLE to do QSORRES when QSTESTCD = HAQ0123
32	Take a bath? field_032	Without ANY difficulty With SOME difficulty With MUCH difficulty UNABLE to do QSORRES when QSTESTCD = HAQ0124
33	Get on and off the toilet? field_033	Without ANY difficulty With SOME difficulty With MUCH difficulty UNABLE to do QSORRES when QSTESTCD = HAQ0125
34	Reach field_034
35	Reach and get down a 5 lb object (e.g. a bag of potatoes) from just above your head? field_035	Without ANY difficulty With SOME difficulty With MUCH difficulty UNABLE to do QSORRES when QSTESTCD = HAQ0126
36	Bend down to pick up clothing off the floor? field_036	Without ANY difficulty With SOME difficulty With MUCH difficulty UNABLE to do QSORRES when QSTESTCD = HAQ0127
37	Grip field_037
38	Open car doors? field_038	Without ANY difficulty With SOME difficulty With MUCH difficulty UNABLE to do QSORRES when QSTESTCD = HAQ0128
39	Open jars which have been previously opened? field_039	Without ANY difficulty With SOME difficulty With MUCH difficulty UNABLE to do QSORRES when QSTESTCD = HAQ0129
40	Turn taps on and off? field_040	Without ANY difficulty With SOME difficulty With MUCH difficulty UNABLE to do QSORRES when QSTESTCD = HAQ0130
41	Activities field_041
42	Run errands and shop? field_042	Without ANY difficulty With SOME difficulty With MUCH difficulty UNABLE to do QSORRES when QSTESTCD = HAQ0131
43	Get in and out of a car? field_043	Without ANY difficulty With SOME difficulty With MUCH difficulty UNABLE to do QSORRES when QSTESTCD = HAQ0132
44	Do chores such as vacuuming, housework or light gardening? field_044	Without ANY difficulty With SOME difficulty With MUCH difficulty UNABLE to do QSORRES when QSTESTCD = HAQ0133
45	AIDS or DEVICES that you usually use for any of the preceding activities: field_045
46	Raised toilet seat (H) field_046	Yes No QSORRES when QSTESTCD = HAQ0134
47	Bath seat (H) field_047	Yes No QSORRES when QSTESTCD = HAQ0135
48	Bath rail (H) field_048	Yes No QSORRES when QSTESTCD = HAQ0137
49	Long-handled appliances for reach (R) field_049	Yes No QSORRES when QSTESTCD = HAQ0138
50	Jar opener (for jars previously opened) (G) field_050	Yes No QSORRES when QSTESTCD = HAQ0136
51	Any categories for which help is needed from another person field_051
52	Hygiene field_052	Yes No QSORRES when QSTESTCD = HAQ0142
53	Reach field_053	Yes No QSORRES when QSTESTCD = HAQ0143
54	Gripping and opening things field_054	Yes No QSORRES when QSTESTCD = HAQ0144
55	Errands or housework field_055	Yes No QSORRES when QSTESTCD = HAQ0145
56	How well you are doing on a scale of 0 to 100 (0 represents "very well" and 100 represents "very poor" health) field_056	QSORRES
57	How much pain have you had IN THE PAST WEEK? On a scale of 0 to 100 (where zero represents "no pain" and 100 represents "severe pain") field_057	QSORRES when QSTESTCD = HAQ0146

ACQ-7 Questionnaire

Sources: DB1, SDTM | Forms loaded: 5

QS (Questionnaires)

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#	Question	Response / annotation
1	Subject Identifier PT	USUBJID
2	Visit FOLDER	VISIT VISITNUM
3	Date of Assessment ACQDT_RAW	QSDTC
4	On average, how often were you woken at night by your asthma? Q01	QSORRES when QSTESTCD = ACQ0101
5	On average, how bad were your asthma symptoms when you woke up in the morning? Q02	QSORRES when QSTESTCD = ACQ0102
6	In general, how limited were you in your activities because of your asthma? Q03	QSORRES when QSTESTCD = ACQ0103
7	In general, how much shortness of breath did you experience because of your asthma? Q04	QSORRES when QSTESTCD = ACQ0104
8	In general, how much of the time did you wheeze? Q05	QSORRES when QSTESTCD = ACQ0105
9	On average, how many puffs of short-acting bronchodilator have you used each day? Q06	QSORRES when QSTESTCD = ACQ0106
10	Pre-bronchodilator FEV1 (% predicted) Q07	QSORRES when QSTESTCD = ACQ0107

SF-36 v2 Standard — Source CRF Example

Sources: DB1, SDTM | Forms loaded: 5

QS (Questionnaires)

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#	Question	Response / annotation
1	Date of assessment field_001	QSDTC
2	1. In general, would you say your health is: field_002	Excellent Very Good Good Fair Poor QSORRES when QSTESTCD = SF36301
3	2. Compared to one year ago, how would you rate your health now? field_003	Much better now than one year ago Somewhat better now than one year ago About the same as one year ago Somewhat worse now than one year ago Much worse now than one year ago QSORRES when QSTESTCD = SF36302
3.5	Section 3 context: rate how much your current health limits each daily activity. section_03_context
4	3.a. Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports field_004	Yes, limited a lot Yes, limited a little No, not limited at all QSORRES when QSTESTCD = SF36303A
5	3.b. Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf field_005	Yes, limited a lot Yes, limited a little No, not limited at all QSORRES when QSTESTCD = SF36303B
6	3.c. Lifting or carrying groceries field_006	Yes, limited a lot Yes, limited a little No, not limited at all QSORRES when QSTESTCD = SF36303C
7	3.d. Climbing several flights of stairs field_007	Yes, limited a lot Yes, limited a little No, not limited at all QSORRES when QSTESTCD = SF36303D
8	3.e. Climbing one flight of stairs field_008	Yes, limited a lot Yes, limited a little No, not limited at all QSORRES when QSTESTCD = SF36303E
9	3.f. Bending, kneeling, or stooping field_009	Yes, limited a lot Yes, limited a little No, not limited at all QSORRES when QSTESTCD = SF36303F
10	3.g. Walking more than a mile field_010	Yes, limited a lot Yes, limited a little No, not limited at all QSORRES when QSTESTCD = SF36303G
11	3.h. Walking several hundred yards field_011	Yes, limited a lot Yes, limited a little No, not limited at all QSORRES when QSTESTCD = SF36303H
12	3.i. Walking one hundred yards field_012	Yes, limited a lot Yes, limited a little No, not limited at all QSORRES when QSTESTCD = SF36303I
13	3.j. Bathing or dressing yourself field_013	Yes, limited a lot Yes, limited a little No, not limited at all QSORRES when QSTESTCD = SF36303J
13.5	Section 4 context: frequency of work or daily-activity limitations due to physical health during the last four weeks. section_04_context
14	4.a. Cut down on the amount of time you spent on work or other activities field_014	All of the time Most of the time Some of the time A little of the time None of the time QSORRES when QSTESTCD = SF36304A
15	4.b. Accomplished less than you would like field_015	All of the time Most of the time Some of the time A little of the time None of the time QSORRES when QSTESTCD = SF36304B
16	4.c. Were limited in the kind of work or other activities field_016	All of the time Most of the time Some of the time A little of the time None of the time QSORRES when QSTESTCD = SF36304C
17	4.d. Had difficulty performing the work or other activities (for example, it took extra effort) field_017	All of the time Most of the time Some of the time A little of the time None of the time QSORRES when QSTESTCD = SF36304D
17.5	Section 5 context: frequency of work or daily-activity limitations due to emotional problems during the last four weeks. section_05_context
18	5.a. Cut down on the amount of time you spent on work or other activities field_018	All of the time Most of the time Some of the time A little of the time None of the time QSORRES when QSTESTCD = SF36305A
19	5.b. Accomplished less than you would like field_019	All of the time Most of the time Some of the time A little of the time None of the time QSORRES when QSTESTCD = SF36305B
20	5.c. Didn't do work or other activities as carefully as usual field_020	All of the time Most of the time Some of the time A little of the time None of the time QSORRES when QSTESTCD = SF36305C
21	6. During the past 4 weeks, to what extent has your physical health or emotional problems interfered with your normal social activities with family, friends, neighbors or groups? field_021	Not at all Slightly Moderately Quite a bit Extremely QSORRES when QSTESTCD = SF36306
22	7. How much bodily pain have you had during the past 4 weeks? field_022	None Very mild Mild Moderate Severe Very severe QSORRES when QSTESTCD = SF36307
23	8. During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)? field_023	Not at all A little bit Moderately Quite a bit Extremely QSORRES when QSTESTCD = SF36308
23.5	Section 9 context: select the frequency that best describes each feeling during the last four weeks. section_09_context
24	9.a. Did you feel full of life? field_024	All of the time Most of the time Some of the time A little of the time None of the time QSORRES when QSTESTCD = SF36309A
25	9.b. Have you been very nervous? field_025	All of the time Most of the time Some of the time A little of the time None of the time QSORRES when QSTESTCD = SF36309B
26	9.c. Have you felt so down in the dumps that nothing could cheer you up? field_026	All of the time Most of the time Some of the time A little of the time None of the time QSORRES when QSTESTCD = SF36309C
27	9.d. Have you felt calm and peaceful? field_027	All of the time Most of the time Some of the time A little of the time None of the time QSORRES when QSTESTCD = SF36309D
28	9.e. Did you have a lot of energy? field_028	All of the time Most of the time Some of the time A little of the time None of the time QSORRES when QSTESTCD = SF36309E
29	9.f. Have you felt downhearted and depressed? field_029	All of the time Most of the time Some of the time A little of the time None of the time QSORRES when QSTESTCD = SF36309F
30	9.g. Did you feel worn out? field_030	All of the time Most of the time Some of the time A little of the time None of the time QSORRES when QSTESTCD = SF36309G
31	9.h. Have you been happy? field_031	All of the time Most of the time Some of the time A little of the time None of the time QSORRES when QSTESTCD = SF36309H
32	9.i. Did you feel tired? field_032	All of the time Most of the time Some of the time A little of the time None of the time QSORRES when QSTESTCD = SF36309I
33	10. During the past 4 weeks, how much of the time has your physical health or emotional problems interfered with your social activities (like visiting friends, relatives, etc.)? field_033	All of the time Most of the time Some of the time A little of the time None of the time QSORRES when QSTESTCD = SF36310
33.5	Section 11 context: indicate whether each health statement is true or false for you. section_11_context
34	11.a. I seem to get sick a little easier than other people field_034	Definitely true Mostly true Don't know Mostly false Definitely false QSORRES when QSTESTCD = SF36311A
35	11.b. I am as healthy as anyone I know field_035	Definitely true Mostly true Don't know Mostly false Definitely false QSORRES when QSTESTCD = SF36311B
36	11.c. I expect my health to get worse field_036	Definitely true Mostly true Don't know Mostly false Definitely false QSORRES when QSTESTCD = SF36311C
37	11.d. My health is excellent field_037	Definitely true Mostly true Don't know Mostly false Definitely false QSORRES when QSTESTCD = SF36311D