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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.