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Table 2 Timing of research assessments

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

  Baselinea 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  
SIQb   
PHQ-15  
Exercise and activity  
Jenkins Sleep Scale  
Step test  
Borg Scale  
Participant satisfaction      
SSMC/therapy adherence   
EQ-5D    
CSRI    
  1. 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.