Development and content validity of a patient reported outcomes measure to assess symptoms of major depressive disorder

Lasch, Kathryn Eilene; Hassan, Mariam; Endicott, Jean; Piault-Luis, Elisabeth Carine; Locklear, Julie; Fitz-Randolph, Marcy; Pathak, Sanjeev; Hwang, Steve; Jernigan, Kasey

doi:10.1186/1471-244X-12-34

Table 1 Summary of Subjects' Socio-demographic Information

From: Development and content validity of a patient reported outcomes measure to assess symptoms of major depressive disorder

Criteria	Focus Group Population	Focus Group Severity				Content Validation Population	Content Validation Severity
		Severe	Moderate	Mild	In Remission		Severe	Moderate	Mild	In Remission
Sample size	38	15	8	7	8	20	2	7	7	4
Gender (Female)	26 (68.4%)	10	6	4	6	17 (85.0%)	1	6	7	3
Age Mean ± SD (in years) [Range]	47.7 [25-66]	50 [25-66]	44 [34-54]	49 [34-63]	44 [29-56]	43.7 [26-74])	40.5 [35-46])	43.1 [26-52])	44.7 [27-74])	44.3 [31-60])
Ethnicity
Black/African American	6 (15.8%)	3	0	1	2	2 (10.0%)	1	0	1	0
Hispanic/Latino (of any race)	0 (0%)	0	0	0	0	3 (15.0%)	0	0	2	1
White/Caucasian	29 (76.3%)	11	6	6	6	13 (65.0%)	1	6	4	2
Multiracial	0 (0%)	0	0	0	0	1 (5.0%)	0	1	0	0
Other	0 (0%)	0	0	0	0	1 (5.0%)	0	0	0	1
Missing data	3 (7.9%)	1	2	0	0	0 (0%)	0	0	0	0
Location
Georgia	8 (21.1%)	4	4	0	0	0 (0%)	0	0	0	0
Massachusetts	8ⁱ (21.1%)	0	4	0	4	0 (0%)	0	0	0	0
Illinois	6 (15.8%)	3	0	3	0	5 (25.0%)	1	1	3	0
New York	8 (21.1%)	4	0	4	0	0 (0%)	0	0	0	0
Philadelphia	8 (21.1%)	4	0	0	4	0 (0%)	0	0	0	0
Minnesota	0 (0%)	0	0	0	0	6 (30.0%)	0	4	0	2
Louisiana	0 (0%)	0	0	0	0	5 (25.0%)	0	1	2	2
California	0 (0%)	0	0	0	0	4 (20.0%)	1	1	2	0
Born in U.S.
Yes	35 (92.1%)	14	6	7	8	19 (95.0%)	2	7	7	3
No	0 (0%)	0	0	0	0	1 (5.0%)	0	0	0	1
Missing data	3 (7.9%)	1	2	0	0	0 (0%)	0	0	0	0
Level of education
Less than high school	0 (0%)	0	0	0	0	0 (0%)	0	0	0	0
Some high school	0 (0%)	0	0	0	0	0 (0.0%)	1	1	0	1
High school diploma or GED	7 (18.4%)	3	1	1	2	3 (15.0%)	0	1	4	0
Some college	9 (23.7%)	5	2	1	1	5 (25.0%)	0	0	0	0
Vocational school or certificate programⁱ	2 (5.3%)	0	1	1	0	0 (0.0%)	1	4	2	1
College or university degree (2- or 4- year)	9 (23.7%)	2	1	3	3	8 (40.0%)	0	0	0	2
Graduate degree	7 (18.4%)	3	1	1	2	2 (10.0%)	0	1	1	0
Missing data	4 (10.5%)	2	2	0	0	2 (10.0%)	0	0	0	0
Work status
Full-time or part-time	16 (42.1%)	3	5	5	3	8 (40.0%)	1	2	2	3
Full-time or part-time homemaker	0 (0%)	0	0	0	0	4 (20.0%)	0	2	1	1
Unemployed	10 (26.3%)	6	0	1	3	3 (15.0%)	0	1	2	0
Student	0 (0%)	0	0	0	0	1 (5.0%)	0	1	0	0
Retired	1 (2.6%)	1	0	0	0	1 (5.0%)	0	0	1	0
Other (disabled)	3 (7.9%)	1	1	1	0	2 (10.0%)	1	1	0	0
Other (social security)	2 (5.3%)	0	0	0	2	0 (0%)	0	0	0	0
Other (unspecified)	2 (5.3%)	2	0	0	0	0 (0%)	0	0	0	0
Missing data	4 (10.5%)	2	2	0	0	2 (10.0%)	0	1	1	0
Relationship status
Single	15 (39.5%)	8	1	3	3	3 (15.0%)	1	0	2	0
Significant other	3 (7.9%)	0	2	0	1	3 (15.0%)	0	0	2	1
Married	9 (23.7%)	3	1	3	2	11 (55.0%)	1	6	2	2
Separated	1 (2.6%)	0	0	0	1	0 (0.0%)	0	0	0	0
Divorced	6 (15.8%)	2	2	1	1	2 (10.0%)	0	0	1	1
Widowed	0 (0%)	0	0	0	0	0 (0.0%)	0	0	0	0
Other	0 (0%)	0	0	0	0	0 (0.0%)	0	0	0	0
Missing data	4 (10.5%)	2	2	0	0	2 (10.0%)	0	1	1	0
Living situation
Alone	16 (42.1%)	8	1	3	4	1 (5.0%)	0	0	0	1
With family (immediate or extended)	9 (23.7%)	3	2	2	2	12 (60.0%)	1	4	5	2
With a friend(s) or roommate(s)	3 (7.9%)	1	2	0	0	1 (5.0%)	1	0	0	0
With significant other	6 (15.8%)	1	1	2	2	5 (25.0%)	0	2	1	2
At a nursing home	0 (0%)	0	0	0	0	0 (0.0%)	0	0	0	0
Assisted living	0 (0%)	0	0	0	0	0 (0.0%)	0	0	0	0
Other	0 (0%)	0	0	0	0	0 (0.0%)	0	0	0	0
Missing data	4 (10.5%)	2	2	0	0	2 (10.0%)	0	1	1	0

ⁱ: One patient dropped out of study during focus group
Note: Percentages (%) are rounded; each criterion (where appropriate) ≈ 100%.

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ISSN: 1471-244X

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