| Secondary outcome | Derivation |
---|---|---|
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 52Â weeks |
ix) | Serious adverse reactions | Total number up to 52Â weeks |
x) | Adverse events | Total number and the proportion of participants having one or more up to 52Â 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 | Â |
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) |