Article Figures & Data
Tables
Pain VAS pain by paper, VAS pain by electronic diary, BPI total score, SF-36 bodily pain, FIQ pain item, BPI worst pain item, BPI least pain item, BPI average pain item, BPI pain right now item Fatigue Multidimensional fatigue inventory, Multidimensional assessment of fatigue, SF-36 vitality, FIQ tiredness Depression Beck Depression Inventory, Hamilton Rating Scale for Depression total score, HAMD Maier subscale, SF-36 mental component score, SF-36 mental health, HADS depression, FIQ depression Sleep MOS Sleep Scale indices I and II and all subscales, Jenkin’s sleep scale, Global sleep quality, FIQ restedness, HAMD sleep subscale, BPI interference with sleep item Physical function FIQ physical function, SF-36 physical function, SF-36 role physical, Sheehan disability total score, BPI interference with walking item, BPI interference with normal work item Quality of life and multidimensional function SF-36 mental and physical component scores, FIQ total score, EuroQol 5D Patient global impression of change Likert scale Tenderness Tender point count, Pressure pain threshold measured by dolorimeter Dyscognition Multiple abilities self-report questionnaire Anxiety FIQ anxiety, HADS anxiety, HAMD anxiety/somatization subscale Stiffness FIQ stiffness -
VAS: visual analog scale; BPI: Brief Pain Inventory, SF-36: Short Form-36, FIQ: Fibromyalgia Impact Questionnaire, HAMD: Hamilton Rating Scale for Depression, HADS: Hospital Anxiety and Depression Scale.
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- Table 2.
Number of domains and instruments used in clinical trials of 4 different medications.
Medication A B C D Pain > 1 > 1 > 1 > 1 Patient global 1 1 1 1 Fatigue > 1 > 1 > 1 > 1 Multidimensional function > 1 > 1 > 1 1 Sleep 1 > 1 1 >1 Depression > 1 > 1 > 1 > 1 Physical function > 1 > 1 > 1 > 1 Tenderness 1 > 1 1 0 Dyscognition 1 0 0 0 Anxiety 1 > 1 > 1 > 1 Stiffness 1 1 1 0 A B C D Intra-domain Inter-domain Intra-domain Inter-domain Intra-domain Inter-domain Intra-domain Inter-domain Pain 0.82 0.32 0.53 0.26 0.66 0.53 0.62 0.37 Tenderness Single 0.32 0.59 0.21 Single 0.58 ND ND Fatigue 0.64 0.5 0.37 0.27 0.62 0.52 0.66 0.43 Sleep Single 0.49 0.25 0.23 Single 0.52 0.3 0.26 Depression 0.63 0.42 0.37 0.22 0.64 0.36 0.58 0.35 Physical function 0.65 0.45 0.31 0.27 0.66 0.44 0.69 0.35 Multidimensional function 0.57 0.61 0.3 0.27 0.55 0.48 Single 0.5 Dyscognition Single 0.23 ND ND ND ND ND ND Anxiety Single 0.4 0.32 0.24 0.6 0.4 0.58 0.38 Stiffness Single 0.57 Single 0.19 Single 0.57 ND ND -
Single: Single instrument; ND: not done.
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- Table 4.
Mean correlation coefficient between instruments of each domain with patient global impression of change.
Medication A B C D Pain 0.64 0.42 0.64 0.54 Fatigue 0.65 0.4 0.68 0.5 Multidimensional function 0.8 0.57 0.8 0.59 Sleep 0.64 0.46 0.64 0.4 Depression 0.39 0.26 0.63 0.34 Physical function 0.56 0.37 0.56 0.37 Tenderness 0.4 0.34 0.4 ND Dyscognition 0.3 ND ND ND Anxiety 0.48 0.3 > 1 0.3 Stiffness 0.78 0.46 0.74 ND -
ND: not done.
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In this issue
Content and Criterion Validity of the Preliminary Core Dataset for Clinical Trials in Fibromyalgia Syndrome
