Table 1: Gender differences in socio-demographic characteristics & QOL domain scores

MS patients General popn control group P level gender

Variables Men (% or SD) Women (% or SD) X2 (or T) df P Men(% /SD) Women(% /SD) Difference b/w

( 1 ) ( 2 ) (3 ) ( 4 ) pts & control

Education( N = 60/109) N = 61 110

Primary/high schl 35(58.3) 54( 49.6) 38(62.3) 47(42.7) 1 Vs 3: P = 0.8

College/ PG 25 (41.7) 55(50.5) 1.30 2 0.52 23(37.7) 63(57.3) 2 Vs 4: P = 0.4

Occupation (N = 50/83)

Unemployed/student 14(28.0) 37 (44.6) 17(27.9) 54(49.1) 1 Vs 3: P = 0.9

Medium/high skill 36(72.0) 46(55.5) 5.70 3 0.13 45(71.6) 56(50.8) 2 Vs 4: P = 0.6

Marital status (N =60/108)

Single/divorced 32 (53.3) 58 (53.7) 25(40.9) 52(47.2) 1 Vs 3: P = 0.2

Married 28(46.7) 50 (46.3) 0.35 2 0.84 36(59.0) 58(52.7) 2 Vs 4: P = 0.4

Age ( N = 58/108) 32.4(7.6) 32.5 (9.4) NS 32.3(7.6) 32.7(9.1) NS

Age onset illness 26.9(6.8) 27.3 ( 8.2) NS

Duration ill(yrs)(N =60/109) 5.7(5.4) 5.2 (5.3) NS

Disability score (N =60/108) 3.2 (2.1) 2.4( 1.6) 2.7 166 0.008

Depression score (N =49/97) 14.0 (11.4) 14.4(11.2) NS

EDSS classification ( N =169): Mild: 1 -3.5 (139 or 82.2%); Moderate: 4 - 6.5 (22 or 13.0%); Severe: 7 -9 (8 or 4.7%)

EDSS score : Mean = 2.7(1.8); Median = 2.5; Mode = 1.0

Table 2: Diagnostic differences in socio-demographic characteristics & QOL domain scores

Variables Relapsing(% or SD) Progressive (% or SD) X2 (or T) df P

Remitting Primary & sec progressive

Educ(N=145/25)

Intermediate/high sch 67(46.2) 16 (64.0)

College/ PG 73(50.3) 8(32.0) 2.9 2 NS

Occup ( N =114/20)

Unemployed/housewife 23 (20.2) 9 (45.0)

Medium/ high skill 57 ( 50.0) 1 (5.0) 28.1 3 0.000

Marital (N =144/25)

Single 64 (44.4) 10 (40.0)

Married 66 (45.8) 12 (48.0) 0.23 2 NS

Gender ( N = 60/109)

Male 44(73.3) 16 (26.7) 8.9 1 0.003

Female 100 (91.7) 9 (8.30)

Age ( N = 144/23) 31.9(8.8) 35.9(7.5) 2.1 165 0.04

Age onset illness 27.3 (7.9) 26.2 (6.3) 0.6 NS

Duration ill (yrs) 4.6 (4.2) 9.8 (8.1) 4.8 168 0.000

Disability (N =144/25) 2.2 (1.1) 5.9(1.9) 13.8 167 0.000

Depression(N =126/21) 13.7 (10.6) 16.7 (14.4) 1.1 NS**

** Effect size = 0.27 (95% C.I. = - 0.20 – 0.73).

Table 3: Comparative level of group satisfaction with QOL items

Highest satisfaction Moderate satisfaction Bare satisfaction Dissatisfied

(>_ 75% subjects (66 - 74% subjects) (50 – 65% subjects) (< 50% subjects)

1. Patients

Transport (76%) Money (66%), Health satisfaction (57%), life OQOL (41%), feeling pain (47%),

meaningful (56%), safety (57%), medical treatment (25%), enjoy life

health environ (58%), bodily (46%), ability to concentrate (39%),

appearance (53%), sleep (52%), energy (33%), information (42%),

ADL (53%), satisfaction with self leisure activities (45%), ability to get

(58%), personal relations (55%), around (46%), work capacity (46%),

support from friends (50%), living sex (45%), negative feelings (17%)

place (63%), access to health service

(55%).

2. General population

OQOL (81%), ability to Health satisfaction (73%), Feeling pain (51%), life meaningful Enjoy life (44%), ability to

(60%) concentrate (40%)

get around (82%), medical treatment (69%), feeling safe (60%), energy for life (55%), healthy environment (49%),

work capacity (77%), self satisfaction (74%), bodily appearance (55%), sleep (58%), money (42%), information (39%),

leisure activities (26%),

transport (77%), personal relations (70%), ADL (65%) support from friends (50%) access to health service

satisfaction with sex (66%), (45%), negative feeling (17%)

living place (72%)

Table 4: Comparison of QOL domain scores by gender and MS type Versus matched general population control group

MS patients General popn control group P level gender

Variables Men ( SD) Women (SD) P Men(SD) Women(SD) Difference b/w

( 1 ) ( 2 ) (3 ) ( 4 ) pts & control

A. By gender

WHOQOL-Bref domains 1 Vs 3; 2 Vs 4, respectively*

Physical health (N= 58/108) 9.8(2.6) 9.6(2.3) NS 11.2(1.8) 10.5(2.0) P = 0.0008; 0.002

Psychol health (N =59/109) 15.6(3.5) 15.9(3.8) NS 18.1(2.4) 17.1(2.9) P = 0.0001; 0.009

Independence ( N =57/109) 12.9(3.7) 12.6(2.9) NS 16.1(2.4) 15.7(2.4) P = 0.0001; 0.0001

Social relations (58/105) 9.6(2.8) 9.8(2.6) NS 11.5(1.7) 10.8(2.5) P = 0.0001; 0.006

Environment ( N =57/102) 27.5 (5.4) 27.5(5.1) NS 28.3(4.4) 28.3(5.3) P = 0.4; 0.3

Spiritual ( N =59/108) 3.2 (1.0) 3.5(1.0) NS 3.7(0.9) 3.7(1.0) P = 0.005; 0.2

General facet ( N =59/107) 6.9(1.6) 6.7(1.7) NS 8.1(1.2) 7.9(1.5) P = 0.0001; 0.0001

4 –domain physical health 22.6 (5.7) 22.1 (4.8) NS 27.3(3.8) 26.3(3.9) P = 0.0001; 0.0001

4 –domain psychol health 18.8(4.3) 19.3(4.5) NS 21.8(3.1) 20.8(3.8) P = 0.0001; 0.009

B. By MS type General popn control group: N = 171

Domains RRMS(SD) PMS ( SD) T df P Mean (SD) P level differences: pts Vs control

(1) (2) ( 3 ) 1 Vs 3; 2 Vs 3, respectively**

Physical (N=141/25) 10.0 (2.1) 7.6(2.9) 5.1 164 0.000 10.8(1.9) P = 0.0005; 0.0001

Psychol (N =143/25) 16.4 (3.1) 12.0 (4.8) 5.9 166 0.000 17.4(2.8) P = 0.003; 0.0001

Independence (N =142/24) 13.2 (2.7) 9.2 (4.1) 6.3 164 0.000 15.9(2.3) P = 0.0001; 0.0001

Social relations(N =140/24) 10.3 (2.2) 6.5 (3.2) 7.2 162 0.000 11.1(2.2) P = 0.002; 0.0001

Environment ( N =135/24) 28.4(4.6) 22.4 (5.7) 5.7 157 0.000 28.3(4.9) P = 0.9; 0.0001

Spiritual ( N = 142/25) 3.5 ( 0.9) 2.5 (1.2) 4.8 165 0.000 3.7(0.9) P = 0.05; 0.0001

General facet ( N =142/25) 7.1 (1.2) 5.0 (2.3) 6.7 165 0.000 8.0(1.4) P = 0.0001; 0.0001

* For significant differences: t ranged from 2.6 to 8.6; df = 117, 215, respectively.

** For significant differences: t ranged from 2.9 to 9.5; df = 309, 193, respectively.

Table 5: Factors associated with QOL in multivariate analysis: significant covariates of QOL domains in ANCOVA**

Factors or covariates Domains with significant impact F P

Depression Psychological health 13.4 0.0001

(Total BDI scores) Physical health 6.3 0.01

Independence 10.0 0.002

Social relations 4.7 0.03

Spiritual 19.2 0.001

Disability score Physical health 10.3 0.002

(EDSS scores) Social relations 4.4 0.04

Environment 4.1 0.05

Age of patient Independence 3.9 0.05

Social relations 5.2 0.02

Diagnosis effect Social relations 4.2 0.04

Spiritual 4.1 0.05

General facet Health & QOL 7.6 0.007

** Note: After controlling for these covariates, the large differences in QOL domain scores earlier highlighted(Table 4) between the relapsing remitting and others, was significant only for the general facet on health & QOL ( P = 0.005).

Table 6: Differences in QOL domain scores between patients who felt well and those who felt currently ill

Mean (SD) Statistics

QOL domain Feel ill Not feel ill T df P

Physical (N =124/40) 9.3 (2.4) 10.8 (2.3) 3.3 162 0.001

Psychol ( N = 125/41) 15.3 (3.9) 17.1 (2.7) 2.7 164 0.007

Independence (N =124/40) 12.2(3.2) 14.1( 3.2) 3.3 162 0.001

Social relations (N =120/42) 9.4(2.8) 10.8(2.1) 3.1 160 0.003

Environment (N = 118/40) 26.9(5.3) 29.4(4.7) 2.7 156 0.008

Spiritual (N =124/41) 3.2 (1.1) 3.9(0.8) 3.6 163 0.000

General facet (N =125/40) 6.6 (1.7) 7.5 (1.3) 3.2 163 0.002

4-d Physical (N= 123/39) 21.5 (4.9) 24.7(5.1) 3.4 160 0.001

4-d Psychol ( N =124/41) 18.5(4.7) 20.9(3.1) 3.2 163 0.002

Caregiver impression ratings: The caregivers rated the patients in the same direction, such that, in all domains, patients who felt well were judged to have significantly higher QOL scores. Except the spiritual domain ( t = 1.9, P = 0.053), t ranged from 2.4 to 4.4,, df ranged from 138 – 143, P ranged from 0.02 to 0.000 ( mostly P = 0.000).

Table 7: Comparison of QOL domain scores for patients on immuno-modulatory drugs Vs those not on immuno-moduolatory drugs

QOL domains: Immuno-modulatory drugs Other drugs F df P Signif different grps

Mean (SD) Mean (SD)

Rebif( N =14) Avonex(N =75) Betaseron(N= 54) (N = 9)

( 1) ( 2) ( 3) (4 )

Physical health 10.7(2.2) 9.5(2.4) 9.6(2.2) 7.7(2.8) 3.1 3/144 0.03 1 > 4

Psychological health 16.3(2.8) 15.5(3.6) 15.6(3.8) 15.4(4.9) 0.9 -

Independence 13.1(2.7) 12.5(2.9) 12.7(3.5) 9.9(3.9) 2.2 3/146 0.05 1 & 3 > 4

Social relations 9.1(2.7) 9.8(2.4) 9.6(2.9) 8.9(2.8) 0.6 -

Environment 26.2(4.2) 27.6(5.3) 27.1(5.0) 25.0(5.4) 0.5 -

Spiritual 3.1(1.2) 3.4(0.9) 3.3(0.9) 3.3(1.4) 0.8 -

General facet 7.3(1.5) 6.8(1.6) 6.7(1.9) 5.8(1.9) 2.1 3/147 0.05 1 > 4

Depression(BDI)** 16.3(8.3) 15.4(10.3) 12.3(9.3) 21.6(25.8) 2.0 3/127 0.05 4 > 3**

Disability (EDSS) 3.4(1.3) 2.7(1.7) 2.6(2.0) 4.4(2.5) 2.9 3/147 0.04 4 > 2 & 3

** Effect size (ES) calculations( 95% C.I.) : 4 Vs 1: ES = 0.31(- 0.54 – 1.14); 4 Vs 2: ES = 0.49 (- 0.21 – 1.18);

4 Vs 3: ES = 0.73(0.00 -1.18)

Duration of drug treatment: Mean= 2.9(2.6), range = 0.5 – 14 yrs, median = 2.5 yrs, mode = six months

Only one subject was on glatiramer acetate (copaxone), not included in this analysis.

Table 8: Correlation of patient and caregiver impression for items of WHOQOL-Bref ( Kendall’s tau_b) *

WHOWOL item r N P QOL domains r N P

Overall rating QOL 0.33 145 0.000 Physical health 0.37 141 0.000

Health satisfaction 0.27 146 0.000 Psychol health 0.33 141 0.000

Pain feelings 0.15 144 0.03 Independence 0.34 137 0.000

Med treatment need - 0.15 141 0.03 Social relations 0.35 137 0.000

Enjoyment of life - 0 08 144 0.26 Environment 0.40 132 0.000

Life meaningful 0.19 144 0.007 Spiritual 0.19 144 0.007

Able to concentrate 0.28 144 0.000 General facet 0.29 145 0.000

Safety in daily life 0.35 144 0.000

Environmental health 0.24 144 0.001

Energy for life 0.36 143 0.000

Bodily appearance satisfaction 0.33 144 0.000

Enough money for needs 0.31 141 0.000

Available information 0.23 142 0.001

Leisure opportunity 0.26 142 0.000

Ability to get around 0.45 142 0.000

Sleep satisfaction 0.24 145 0.001

Activities of daily living 0.23 145 0.001

Work capacity 0.35 146 0.000

Self satisfaction 0.27 145 0.000

Personal relationship 0.37 144 0.000

Satisfaction sex life 0.37 141 0.000

Satisfaction friends’ support 0.27 146 0.000

Condition place of living 0.25 142 0.001

Access to health service 0.14 146 0.06

Satisfaction with transport 0.28 146 0.000

Negative feelings 0.20 146 0.005

* Intra-class correlation coefficient (ICC) for Pts WHOQOL-Bref & Caregiver impression: ICC = 0.96 (95% C.I. = 0.95 -0.97)

.

Table 9: Differences between patient and caregiver impression scores for WHOQOL domains

QOL Domains: Patient: Caregiver impression T df P

Mean (SD) Mean (SD)

Physical health 9.9(2.1) 9.8 (1.8) NS

Psychological health 16.4 (3.1) 15.9 (2.3) NS

Independence 13.1 (2.7) 12.8 (2.2) NS

Social relations 10.3 (2.3) 10.0 (2.3) NS

Environment 28.4 (4.6) 27.0 (4.6) 3.1 114 0.002

Spiritual 3.5 (0.9) 3.5(0.9) NS

General facet 7.1 (1.2) 6.7 (1.5) 3.2 124 0.002

Table 10: Predictors of patient’s QOL: general facet health & QOL as dependent variable

Dependent variable Predictors Variance(%) Total(%) B T P

General facet pt’s QOL

- Disability status 34.0 46.9 - 0.46 - 5.3 0.000

- Caregiver impression 10.1 0.32 3.6 0.000

general facet health & QOL

-Caregiver anxious

about having illness 2.8 - 0.17 - 2.2 0.03

Variables not in the equation: age of patient, duration of illness, age at onset of illness, caregiver feeling sad about patient’s illness, caregiver feeling disgusted with patient’s condition, caregiver feeling tired/exhausted about caring for patient, BDI total score, general facet for caregiver.