Background
Methods
Study design
Sample population
Data collection procedures
Patient questionnaire
Patient perception of treatment effectiveness and satisfaction
Health-related quality of life and core symptom domains
Healthcare costs
Statistical analyses
Results
Study sample
FM Severity | |||||
---|---|---|---|---|---|
Characteristic | Total (n = 88) | Mild (n = 17) | Moderate (n = 33) | Severe (n = 38) |
P -value
a
|
Age, years | 0.303 | ||||
Mean (SD) | 55.2 (11.8) | 51.3 (11.3) | 56.1 (11.3) | 56.2 (12.4) | |
Median (range) | 57.0 (19.0-80.0) | 55.0 (34-69) | 57.0 (33-80) | 57.5 (19-78) | |
Gender, n (%) | 1.0 | ||||
Male | 14 (15.9) | 3 (17.6) | 5 (15.2) | 6 (15.8) | |
Female | 74 (84.1) | 14 (82.4) | 28 (84.8) | 32 (84.2) | |
Employment status, n (%)b
| 0.682 | ||||
Employed, full-time | 23 (26.1) | 5 (31.3) | 11 (33.3) | 7 (21.9) | |
Employed, part-time | 6 (6.8) | 1 (6.3) | 4 (12.1) | 1 (3.1) | |
Disabled | 8 (9.1) | 1 (6.3) | 3 (9.1) | 4 (12.5) | |
Full-time homemaker | 2 (2.3) | 1 (6.3) | 0 (0) | 1 (3.1) | |
Unemployed | 6 (6.8) | 2 (12.5) | 1 (3.0) | 3 (9.4) | |
Retired | 33 (37.5) | 5 (31.3) | 13 (39.4) | 15 (46.9) | |
Other | 2 (2.3) | 1 (6.3) | 1 (3.0) | 0 (0) | |
Student | 1 (1.1) | 0 (0) | 0 (0) | 1 (3.1) |
FM Severitya
| |||||
---|---|---|---|---|---|
Characteristic | Total (n = 88) | Mild (n = 17) | Moderate (n = 33) | Severe (n = 38) |
P -value
b
|
Duration of FM symptomsc, n (%) | 0.517 | ||||
3-6 months | 10 (11.4) | 3 (17.6) | 2 (6.1) | 5 (13.2) | |
7-11 months | 4 (4.5) | 0 (0.0) | 2 (6.1) | 2 (5.3) | |
1-5 years | 46 (52.3) | 8 (47.1) | 22 (66.7) | 16 (42.1) | |
6-10 years | 20 (22.7) | 5 (29.4) | 4 (12.1) | 11 (28.9) | |
> 10 years | 7 (8.0) | 1 (5.9) | 3 (9.1) | 3 (7.9) | |
Time since diagnosis, years | 0.983 | ||||
Mean (SD) | 3.2 (2.9) | 3.2 (2.5) | 3.1 (2.6) | 3.4 (3.3) | |
Median | 2 | 3 | 2 | 2 | |
Number of positive MTPS points | 0.165 | ||||
Mean (SD) | 13.0 (3.4) | 14.4 (2.9) | 12.6 (3.1) | 12.7 (3.9) | |
Median | 13 | 15 | 12 | 12 | |
Comorbid conditionsd
| |||||
Anxiety, n (%) | 67 (76.1) | 12 (70.6) | 26 (78.8) | 29 (76.3) | 0.808 |
Sleep Disturbance/Insomnia, n (%) | 52 (59.1) | 10 (58.8) | 22 (66.7) | 20 (52.6) | 0.477 |
Chronic Fatigue Syndrome, n (%) | 46 (52.3) | 13 (76.5) | 17 (51.5) | 16 (42.1) | 0.055 |
Depression, n (%) | 40 (45.5) | 6 (35.3) | 15 (45.5) | 19 (50.0) | 0.618 |
Headache/Migraine, n (%) | 30 (34.1) | 6 (35.3) | 7 (21.2) | 17 (44.7) | 0.113 |
Restless Leg Syndrome, n (%) | 22 (25.0) | 8 (47.1) | 8 (24.2) | 6 (15.8) | 0.043 |
Irritable Bowel Syndrome, n (%) | 16 (18.2) | 3 (17.6) | 4 (12.1) | 9 (23.7) | 0.450 |
Raynaud's Syndrome, n (%) | 4 (4.5) | 1 (5.9) | 1 (3.0) | 2 (5.3) | 1.00 |
Other, n (%) | 6 (6.8) | 1 (5.9) | 1 (3.0) | 4 (10.5) | 0.562 |
Number of comorbid conditions, n (%) | 0.934 | ||||
0 | 5 (5.7) | 1 (5.9) | 1 (3.0) | 3 (7.9) | |
1 | 15 (17.0) | 2 (11.8) | 5 (15.2) | 8 (21.1) | |
2 | 16 (18.2) | 4 (23.5) | 6 (18.2) | 6 (15.8) | |
≥3 | 52 (59.1) | 10 (58.8) | 21 (63.6) | 21 (55.3) | |
Number of comorbid conditionse
| 0.637 | ||||
Mean (SD) | 3.4 (1.8) | 3.8 (2.0) | 3.2 (1.5) | 3.5 (2.1) | |
Median (range) | 3 (1-8) | 4 (1-7) | 3 (1-6) | 3 (1-8) |
Patients' perception of treatment effectiveness and satisfaction
FM Severity | |||||
---|---|---|---|---|---|
Characteristic | Total (n = 88) | Mild (n = 17) | Moderate (n = 33) | Severe (n = 38) |
P -value
a
|
Number of office visits over the past 3 months | 0.319 | ||||
Mean (SD) | 2.9 (1.9) | 3.1 (1.3) | 2.5 (1.3) | 3.3 (2.4) | |
Median | 3 | 3 | 3 | 3 | |
Other physician visits over the past 3 monthsb, n (%) | 0.379 | ||||
Yes | 22 (25.0) | 2 (12.5) | 10 (31.3) | 10 (27.0) | |
No | 63 (71.6) | 14 (87.5) | 22 (68.8) | 27 (73.0) |
Impact of fm on health-related quality of life and core symptom domains
Scale | Total (n = 88) | Mild (n = 17) | Moderate (n = 33) | Severe (n = 38) |
P-valuea
|
---|---|---|---|---|---|
EQ-5D | |||||
Health State valuation | 0.37 (0.33) | 0.65 (0.18) | 0.44 (0.27) | 0.18 (0.33) | < 0.001 |
Overall Health Status Ratings | |||||
Current Overall Health | 52.9 (17.8) | 65.4 (14.2) | 53.0 (11.9) | 47.7 (20.9) | 0.006 |
Pain-Free Overall Health | 80.6 (19.2) | 86.9 (12.8) | 80.5 (22.6) | 77.9 (17.6) | 0.106 |
FIQ | |||||
Total Score | 54.8 (17.3) | 29.3 (8.8) | 50.0 (5.5) | 70.4 (8.5) | |
Physical Impairment | 3.4 (2.1) | 1.6 (1.9) | 3.2 (2.0) | 4.5 (1.7) | |
Feel Good | 7.1 (2.8) | 4.4 (2.9) | 7.6 (2.5) | 8.0 (2.3) | |
Work Missed | 3.0 (3.5) | 0.6 (1.9) | 1.1 (2.1) | 5.6 (3.3) | |
Do Work | 6.0 (2.3) | 3.2 (1.3) | 5.4 (1.4) | 7.6 (1.9) | |
Pain | 6.2 (2.2) | 3.2 (1.4) | 5.9 (1.4) | 7.9 (1.5) | |
Fatigue/Tired | 6.9 (2.1) | 4.7 (1.9) | 6.7 (1.6) | 8.3 (1.3) | |
Rested | 6.8 (2.5) | 4.3 (2.3) | 6.5 (2.2) | 8.1 (1.7) | |
Stiffness | 6.6 (2.4) | 4.0 (2.0) | 6.5 (2.1) | 8.0 (1.8) | |
Anxiety | 5.3 (2.7) | 2.4 (1.9) | 4.7 (2.0) | 7.1 (2.0) | |
Depression | 4.3 (3.2) | 1.2 (1.4) | 3.2 (2.4) | 6.6 (2.7) | |
BPI-sf | |||||
Pain Intensity: Worst | 6.2 (2.0) | 4.4 (1.9) | 6.0 (1.4) | 7.3 (1.8) | < 0.001 |
Average pain | 4.8 (1.9) | 3.1 (1.7) | 4.6 (1.3) | 5.7 (1.8) | < 0.001 |
Pain Severity Index | 4.9 (1.8) | 3.2 (1.4) | 4.7 (1.2) | 6.0 (1.7) | < 0.001 |
Pain Interference Index | 5.1 (1.9) | 3.0 (1.1) | 4.6 (1.2) | 6.6 (1.6) | < 0.001 |
General activity | 5.6 (2.1) | 3.7 (1.7) | 5.3 (1.4) | 6.8 (2.1) | < 0.001 |
Mood | 4.8 (2.6) | 2.9 (2.3) | 4.2 (2.1) | 6.3 (2.3) | < 0.001 |
Walking ability | 4.6 (2.7) | 2.2 (1.5) | 4.2 (2.3) | 6.0 (2.6) | < 0.001 |
Normal work | 6.1 (2.0) | 3.7 (1.1) | 5.6 (1.4) | 7.6 (1.5) | < 0.001 |
Relations with other people | 4.0 (2.6) | 1.9 (1.8) | 3.2 (2.3) | 5.7 (2.2) | < 0.001 |
Sleep | 5.5 (2.9) | 3.8 (2.8) | 4.5 (2.5) | 7.1 (2.4) | < 0.001 |
Enjoyment of life | 5.1 (2.4) | 2.9 (1.7) | 4.7 (2.2) | 6.5 (2.0) | < 0.001 |
MOS | |||||
Sleep Problems Index | 52.8 (16.8) | 45.9 (20.5) | 48.6 (14.9) | 59.5 (14.4) | 0.008 |
Sleep disturbance | 53.8 (25.1) | 47.6 (27.8) | 49.8 (24.6) | 60.1 (23.6) | 0.106 |
Sleep adequacy | 34.2 (24.1) | 42.4 (24.4) | 34.6 (22.9) | 30.3 (24.7) | 0.201 |
Sleep somnolence | 43.3 (22.6) | 38.8 (26.7) | 36.0 (18.9) | 51.6 (21.4) | 0.006 |
Snoring | 43.9 (31.2) | 38.7 (29.7) | 36.4 (28.0) | 53.5 (32.9) | 0.074 |
Sleep SOB or headache | 35.2 (26.9) | 25.0 (33.9) | 27.3 (23.4) | 46.3 (22.8) | 0.001 |
Sleep quantity (hours) | 6.4 (1.7) | 6.5 (1.6) | 6.8 (1.4) | 6.0 (1.9) | 0.092 |
HADS | |||||
Anxiety | 10.4 (4.1) | 8.0 (4.1) | 9.9 (2.9) | 11.9 (4.4) | 0.002 |
Depression | 7.9 (4.3) | 4.7 (3.0) | 6.6 (3.3) | 10.5 (4.0) | < 0.001 |
Impact of fm on productivity
FM Severity | |||||
---|---|---|---|---|---|
Characteristic | Total (n = 29) | Mild (n = 6) | Moderate (n = 15) | Severe (n = 8) |
P -value
a
|
Days missed from work during the past 4 weeksb
| 0.309 | ||||
n | 27 | 6 | 13 | 8 | |
Mean (SD) | 2.7 (6.0) | 0.5 (1.2) | 1.2 (2.8) | 6.9 (9.6) | |
Median (range) | 0 (0-20) | 0 (0-3) | 0 (0-8) | 0 (0-20) | |
Reduced productivity at work during the past 4 weeksb, n (%) | 0.281 | ||||
All of the time | 4 (13.8) | 0 (0.0) | 2 (13.3) | 2 (25.0) | |
Most of the time | 4 (13.8) | 0 (0.0) | 3 (20.0) | 1 (12.5) | |
A good bit of the time | 9 (31.0) | 1 (16.7) | 4 (26.7) | 4 (50.0) | |
Some of the time | 11 (37.9) | 4 (66.7) | 6 (40.0) | 1 (12.5) | |
A little of the time | 1 (3.4) | 1 (16.7) | 0 (0.0) | 0 (0.0) | |
None of the time | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Impact of fm on healthcare costs
Resource Utilization Cost | Total (n = 88) | Mild (n = 17) | Moderate (n = 33) | Severe (n = 38) | |||||
---|---|---|---|---|---|---|---|---|---|
Mean (SD) | Median | Mean (SD) | Median | Mean (SD) | Median | Mean (SD) | Median |
P -value
a
| |
Direct Medical Costs to Payerb
| |||||||||
Physician Visits | 259 (163) | 264 | 271 (118) | 264 | 219 (112) | 264 | 288 (208) | 264 | |
Diagnostic Tests | 14 (38) | 0 | 26 (61) | 0 | 7 (20) | 0 | 13 (37) | 0 | |
Prescription Medications | 245 (345) | 107 | 153 (207) | 43 | 213 (312) | 102 | 314 (409) | 144 | |
Hospitalizations | 104 (972) | 0 | 0 (0) | 0 | 276 (1,587) | 0 | 0 (0) | 0 | |
Direct Medical Costs to Patientc
| 186 (425) | 0 | 113 (256) | 0 | 233 (448) | 0 | 179 (467) | 0 | |
Total Direct Medical Costs to Society | 808 (1,215) | 540 | 564 (440) | 528 | 949 (1,842) | 504 | 794 (636) | 595 | 0.434 |
Direct Non-Medical Cost to Patientc
| |||||||||
Professional services for ADL | 103 (501) | 0 | 93 (274) | 0 | 108 (428) | 0 | 103 (633) | 0 | |
Total Indirect Costs to Societyc
| |||||||||
Lost productivity | 6,990 (14,561) | 0 | 4,816 (12,433) | 0 | 5,576 (12,736) | 0 | 9,190 (16,808) | 0 | |
Total Direct and Indirect Costs to Society | 7,900 (14,868) | 616 | 5,473 (12,852) | 610 | 6,633 (13,498) | 528 | 10,087 (16,785) | 890 | 0.185 |