|
iii)
|
Serious deterioration
|
Absent/present - derived using the DMEC algorithm
|
|
iv)
|
Serious deterioration: Component 1
|
Absent/present - SF-36 physical function score diminishing by 20 or more points between baseline and any two consecutive assessment interviews
|
|
v)
|
Serious deterioration: Component 2
|
Absent/present - Participant-rated CGI change score of ‘much worse’ or ‘very much worse’ at two consecutive assessment interviews
|
|
vi)
|
Serious deterioration: Component 3
|
Absent/present - Withdrawal from therapy more than 8 weeks after randomisation due to participant’s reported worsening of their condition
|
|
vii)
|
Serious deterioration: Component 4
|
Absent/present - A serious adverse reaction
|
|
viii)
|
Serious adverse events
|
Total number up to 52 weeks
|
|
ix)
|
Serious adverse reactions
|
Total number up to 52 weeks
|
|
x)
|
Adverse events
|
Total number and the proportion of participants having one or more up to 52 weeks
|
|
xi)
|
Withdrawals from intervention
|
No/yes; person responsible; reason; days from randomisation
|
|
xii)
|
Participant-rated CGI
|
Positive change; no change; negative change
|
|
xiii)
|
Anxiety (HADS-A)
|
Total (sum) of the anxiety items of the HADS (higher scores indicate more anxiety)
|
|
xiv)
|
Depression (HADS-D)
|
Total (sum) of the depression items of the HADS (higher scores indicate more depression)
|
|
xv)
|
Six minute walking test
|
Total number of meters walked - derived from the number of 10 meter lengths plus any partial distance
|
|
xvi)
|
Work and social adjustment
|
Total (sum) of all items (higher scores indicate less adjustment)
|
|
xvii)
|
Participant satisfaction
|
Very satisfied; moderately satisfied; slightly satisfied; neither; slightly dissatisfied; moderately dissatisfied; very dissatisfied
|
|
xviii)
|
CDC Symptoms (#)
|
Total (sum) of CDC symptoms 1 to 8
|
|
xix)
|
Jenkins Sleep Score
| |
|
xx)
|
CSRI - service costs
|
Total (sum) costs - derived by assigning costs (£) to each relevant item in the CSRI
|
|
xxi)
|
CSRI - societal costs
|
Total (sum) costs - derived by assigning costs (£) to each relevant item in the CSRI
|
|
xxii)
|
CSRI - NHS costs
|
Total (sum) costs - derived by assigning costs (£) to each relevant item in the CSRI
|
|
xxiii)
|
CSRI - insurance/benefit costs
|
Total (sum) costs - derived by assigning costs (£) to each relevant item in the CSRI
|
|
xxiv)
|
EuroQol
|
Item scores for Q1 to 5 will be weighted by utility values and summed to produce a total (this can range from −0.59 to 1, with 1 indicating full health)
|
