Secondary outcome measures – Secondary efficacy measures
1. The Chalder Fatigue Questionnaire Likert scoring (0,1,2,3) will be used to compare responses to treatment
27].
[Dropped: Became a primary outcome measure]
2. The self-rated Clinical Global Impression (CGI) change score (range 1 – 7) provides a self-rated global measure of change, and has been used in previous trials
45]. As in previous trials, we will consider scores of 1 or 2 as a positive outcome ("very much better" and "much better") and the rest as non-improvement
23].
3. The CGI change scale will also be rated by the treating therapist at the end of session number 14, and by the SSMC doctor at the 52-week review.
[Therapist bit never reported. SSMC doctor rating used if missing score, as I recall]
4. "Recovery" will be defined by meeting all four of the following criteria: (i) a Chalder Fatigue Questionnaire score of 3 or less
27], (ii) SF-36 physical Function score of 85 or above
47,
48], (iii) a CGI score of 1
45], and (iv) the participant no longer meets Oxford criteria for CFS
2], CDC criteria for CFS
1] or the London criteria for ME
40].
[Not mentioned above but has been reported on (with major changes)]
5. The Hospital Anxiety and Depression Scale scores in both anxiety and depression sub-scales
38].
6. The Work and Social Adjustment scale provides a more comprehensive measure of participation in occupational and domestic activities
33].
7. The EuroQOL (EQ-5D) provides a global measure of the quality of life
39].
8. The six-minute walking test will give an objective outcome measure of physical capacity
31].
9. The self-paced step test of fitness
43].
[Looks like it was dropped]
10. The Borg Scale of perceived physical exertion
44], to measure effort with exercise and completed immediately after the step test.
[Looks like it was dropped]
11. The Client Service Receipt Inventory (CSRI), adapted for use in CFS/ME
31], will measure hours of employment/study, wages and benefits received, allowing another more objective measure of function.
12. An operationalised Likert scale of the nine CDC symptoms of CFS
1].
[Changed to presence/absence of symptoms]
13. The Physical Symptoms (Physical Health Questionnaire 15 items(PHQ15))
35].
[Looks like it was dropped]
14. A measurement of participant satisfaction with the trial will also be taken at 52 weeks [53].