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Table 3 Derivation of secondary outcomes

From: A randomised trial of adaptive pacing therapy, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome (PACE): statistical analysis plan

  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 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)
  1. Note: CDC, Centers for Disease Control; CGI, clinical global impression; CSRI, client service receipt inventory; DMEC, data monitoring and ethics committee; HADS, hospital anxiety and depression scale.