Too little, too late
There are very strict rules re responding to articles in the Lancet. The deadline was 14 days after on-line publication. March 4th. Ooops Kim.
There are many points in the PACE study (1) that require criticism. I cannot post the letter I submitted, in case it jeopardizes publication, but one key point was that they changed the outcome measures from the ones stated in the study design (2).
They decided, mid-study, to reduce the SF36 score (3) designated as "recovery" from 75 to 60. An SF36 score of 60 is normative for 75 - 84 year olds. The average age of study participants was 38. Even more damning, the entry criteria included an SF36 score of 65 or lower.
Actometers were purchased, and used to assess patients at the start of the study. They were not used to measure outcomes, which rings big alarm bells with many. Instead, the subjective blunt instrument of the Chalder Fatigue Scale (4) was used, and the subjective 'improvements' so measured equate to 6 - 7 points on that 33 point scale. Hardly a world beating result.
1) White, PD; Goldsmith, KA; Johnson, AL et al Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial; The Lancet, Early Online Publication, 18 February 2011doi:10.1016/S0140-6736(11)60096-2
2) PD White, MC Sharpe, T Chalder , JC DeCesare and R Walwyn for the PACE trial group; Protocol for the PACE trial: A randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy; BMC Neurology 2007, 7:6
3) Bowling, A; Bond, M; Jenkinson, C and Lamping, DL; Short Form 36 (SF-36) Health Survey questionnaire: which normative data should be used? Comparisons between the norms provided by the Omnibus Survey in Britain, the Health Survey for England and the Oxford Healthy Life Survey; Oxford Journals Medicine Journal of Public Health Volume21, Issue3 Pp. 255-270
4) Chalder, T; Berelowitz, G; Pawlikowska T; et al: Development of a Fatigue Scale; J. Psychosom. Res. Vol.37, No.2, pp 147-153, 1993
That took me 30 minutes. But then I know the subject.