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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.