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

Table 2 Timing of research assessments

	Baseline^a	Week 12	Week 24	Week 52	Discontinuation of therapy	Discontinuation of follow-up
Demographic and clinical data
Eligibility	✓
Centre	✓
Date of birth	✓
Gender	✓
Ethnicity	✓
Marital status/dependents	✓
Living arrangements	✓
Usual place of residence	✓
Educational level	✓
Group membership	✓			✓
Height and weight	✓
Employment status	✓
Benefits/pensions status	✓
Start of current illness	✓
Start of disabling episode	✓
Comorbid medical conditions	✓	✓	✓	✓	✓
Medications and therapies	✓	✓	✓	✓	✓
Oxford criteria	✓			✓	✓
CDC criteria/CDC symptoms	✓			✓	✓
London criteria	✓			✓	✓
Fibromyalgia	✓			✓	✓
Past medical history	✓
Preferred intervention group	✓
Adverse events		✓	✓	✓	✓
Therapist data ^c
Primary qualification	✓
Years of experience	✓
Years of relevant experience	✓
Employment grade	✓
Doctor data ^c
Discipline	✓
Employment grade	✓
Questionnaires
Chalder fatigue	✓	✓	✓	✓	✓	✓
SF-36 physical functioning	✓	✓	✓	✓	✓	✓
Participant CGI		✓	✓	✓	✓	✓
Doctor CGI				✓	✓	✓
Therapist CGI			✓		✓	✓
Walking test	✓		✓	✓	✓
Actigraphy	✓
HADS	✓	✓	✓	✓	✓
Self-efficacy	✓	✓	✓	✓	✓
WSAS	✓	✓	✓	✓	✓
SIQ^b	✓	✓	✓	✓
PHQ-15	✓	✓	✓	✓	✓
Exercise and activity	✓	✓	✓	✓	✓
Jenkins Sleep Scale	✓	✓	✓	✓	✓
Step test	✓	✓	✓	✓	✓
Borg Scale	✓	✓	✓	✓	✓
Participant satisfaction			✓	✓
SSMC/therapy adherence			✓	✓	✓	✓
EQ-5D	✓		✓	✓	✓
CSRI	✓		✓	✓	✓

^aBaseline was conducted over two research visits prior to randomisation; ^bThe SIQ is now known as the Cognitive and Behavioural Questionnaire; ^cThe therapist and doctor data will be kept separate from the trial database and summarised by the Trial Manager (see Baseline Comparability of Randomised Groups); Note: CDC, Centers for Disease Control; CGI, clinical global impression; CSRI, client service receipt inventory; EQ-5D, Euroqol 5 dimensions; HADS, hospital anxiety and depression scale; PHQ15, physical health questionnaire 15; SF-36, short-form 36; SIQ, symptoms interpretation questionnaire; SSMC, standardised specialist medical care; WSAS, work and social adjustment scale.

ISSN: 1745-6215