- Jul 2018
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europepmc.org europepmc.org
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On 2016 Sep 27, Alem Matthees commented:
The 'normal range' was not a strict criterion for recovery nor was it based on healthy scores
The editorial by Bleijenberg & Knoop (2011) contains a misleading statement: “PACE used a strict criterion for recovery: a score on both fatigue and physical function within the range of the mean plus (or minus) one standard deviation of a healthy person’s score. In accordance with this criterion, the recovery rate of cognitive behavioural and graded exercise therapy was about 30%—although not very high, the rate is significantly higher than that with both other interventions.” [1]
However, the PACE publication did not report on "recovery" [2] and the PACE authors issued a statement to that effect [3] despite previously approving the editorial before it was published [4,5]. The normal range overlapped with trial eligibility criteria for severe disabling fatigue [2]. The largest overlap was with SF-36 physical function, where 13% of participants simultaneously met the normal range on this measure and the entry criteria for "significant disability" [6]. The individual participant data recently released from the PACE trial reveals that 45% (60/134) of those within the normal range at 52-week follow-up still met Oxford CFS criteria [7].
It is disappointing that the Lancet and Bleijenberg & Knoop stand by the comment on recovery despite being alerted of the problems [5]. The Press Complaints Commission ruled that the editorial was misleading [4,5]. Oddly enough, both Bleijenberg & Knoop have previously co-authored papers where a score of 60 (the threshold for normal physical function) was regarded as severe impairment [8-11].
The normal range was not based on healthy people of working age only. For example, the normal range for physical function was based on a general population that included the elderly and chronically disabled [3]. If the normal range was based on a healthy population as asserted, the threshold for normal physical function would be 85 points or more, not 60 or more [6]. A preliminary re-analysis of recovery in the PACE trial, based on the protocol-specified recovery criteria, shows that the recovery rates in the CBT and GET groups were 6.8% and 4.4% respectively, and not significantly higher than with specialist medical care alone [7].
References
1) Bleijenberg G, Knoop H. Chronic fatigue syndrome: where to PACE from here? Lancet. 2011 Mar 5;377(9768):786-8. doi: 10.1016/S0140-6736(11)60172-4. Epub 2011 Feb 18. PMID: 21334060. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60172-4/fulltext
2) White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC, Baber HL, Burgess M, Clark LV, Cox DL, Bavinton J, Angus BJ, Murphy G, Murphy M, O'Dowd H, Wilks D, McCrone P, Chalder T, Sharpe M; PACE trial management group. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet. 2011 Mar 5;377(9768):823-36. doi: 10.1016/S0140-6736(11)60096-2. Epub 2011 Feb 18. PMID: 21334061. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3065633/
3) White PD, Goldsmith KA, Johnson AL, Walwyn R, Baber HL, Chalder T, Sharpe M, [on behalf of the coauthors]. The PACE trial in chronic fatigue syndrome — Authors' reply. The Lancet, Volume 377, Issue 9780, Pages 1834 - 1835, 28 May 2011 (Published Online: 17 May 2011). doi:10.1016/S0140-6736(11)60651-X http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60651-X/fulltext
4) http://www.pcc.org.uk/cases/adjudicated.html?article=ODQwOQ
5) Continuing Correspondence Between Countess of Mar and Professor Peter White and Professor Sir Simon Wessely. 26 January 2013. http://forums.phoenixrising.me/index.php?threads/continuing-correspondence-countess-of-mar-and-prof-white-and-prof-sir-s-wessely.21545/
6) Matthees A. Re: Tackling fears about exercise is important for ME treatment, analysis indicates. BMJ Rapid Response. 21 January 2015. http://www.bmj.com/content/350/bmj.h227/rr-16
7) Matthees A, Kindlon T, Maryhew C, Stark P, Levin B. A preliminary analysis of ‘recovery’ from chronic fatigue syndrome in the PACE trial using individual participant data. Virology Blog. 21 September 2016. http://www.virology.ws/wp-content/uploads/2016/09/preliminary-analysis.pdf
8) van't Leven M, Zielhuis GA, van der Meer JW, Verbeek AL, Bleijenberg G. Fatigue and chronic fatigue syndrome-like complaints in the general population. Eur J Public Health. 2010 Jun;20(3):251-7. Epub 2009 Aug 18. PMID: 19689970. http://eurpub.oxfordjournals.org/content/20/3/251.long
9) Tummers M, Knoop H, van Dam A, Bleijenberg G. Implementing a minimal intervention for chronic fatigue syndrome in a mental health centre: a randomized controlled trial. Psychol Med. 2012 Oct;42(10):2205-15. doi: 10.1017/S0033291712000232. Epub 2012 Feb 21. PMID: 22354999. http://www.ncbi.nlm.nih.gov/pubmed/22354999
10) Stulemeijer M, de Jong LW, Fiselier TJ, Hoogveld SW, Bleijenberg G. Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: randomised controlled trial. BMJ. 2005 Jan 1;330(7481):14. Epub 2004 Dec 7. doi: 10.1136/bmj.38301.587106.63. PMID: 15585538. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC539840
11) Heins M, Knoop H, Nijs J, Feskens R, Meeus M, Moorkens G, Bleijenberg G. Influence of symptom expectancies on stair-climbing performance in chronic fatigue syndrome: effect of study context. Int J Behav Med. 2013 Jun;20(2):213-8. doi: 10.1007/s12529-012-9253-2. PMID: 22865100. http://www.ncbi.nlm.nih.gov/pubmed/22865100
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On 2014 Nov 24, Tom Kindlon commented:
Letter published criticising threshold for normal functioning used in PACE Trial:
Bleijenberg and Knoop claimed a strict criterion for recovery was used in the PACE Trial. A letter has been published challenging this: it quotes some population data to show how ridiculous a threshold of 60+ on the SF-36 physical functioning is to define "normal functioning" and recovery (particularly in the PACE Trial given its own entry criteria).
Kindlon T, Baldwin A. Response to: reports of recovery in chronic fatigue syndrome may present less than meets the eye. Evid Based Mental Health doi:10.1136/eb-2014-101961 http://ebmh.bmj.com/content/early/2014/09/19/eb-2014-101961.extract
This comment, imported by Hypothesis from PubMed Commons, is licensed under CC BY.
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- Feb 2018
-
europepmc.org europepmc.org
-
On 2014 Nov 24, Tom Kindlon commented:
Letter published criticising threshold for normal functioning used in PACE Trial:
Bleijenberg and Knoop claimed a strict criterion for recovery was used in the PACE Trial. A letter has been published challenging this: it quotes some population data to show how ridiculous a threshold of 60+ on the SF-36 physical functioning is to define "normal functioning" and recovery (particularly in the PACE Trial given its own entry criteria).
Kindlon T, Baldwin A. Response to: reports of recovery in chronic fatigue syndrome may present less than meets the eye. Evid Based Mental Health doi:10.1136/eb-2014-101961 http://ebmh.bmj.com/content/early/2014/09/19/eb-2014-101961.extract
This comment, imported by Hypothesis from PubMed Commons, is licensed under CC BY. -
On 2016 Sep 27, Alem Matthees commented:
The 'normal range' was not a strict criterion for recovery nor was it based on healthy scores
The editorial by Bleijenberg & Knoop (2011) contains a misleading statement: “PACE used a strict criterion for recovery: a score on both fatigue and physical function within the range of the mean plus (or minus) one standard deviation of a healthy person’s score. In accordance with this criterion, the recovery rate of cognitive behavioural and graded exercise therapy was about 30%—although not very high, the rate is significantly higher than that with both other interventions.” [1]
However, the PACE publication did not report on "recovery" [2] and the PACE authors issued a statement to that effect [3] despite previously approving the editorial before it was published [4,5]. The normal range overlapped with trial eligibility criteria for severe disabling fatigue [2]. The largest overlap was with SF-36 physical function, where 13% of participants simultaneously met the normal range on this measure and the entry criteria for "significant disability" [6]. The individual participant data recently released from the PACE trial reveals that 45% (60/134) of those within the normal range at 52-week follow-up still met Oxford CFS criteria [7].
It is disappointing that the Lancet and Bleijenberg & Knoop stand by the comment on recovery despite being alerted of the problems [5]. The Press Complaints Commission ruled that the editorial was misleading [4,5]. Oddly enough, both Bleijenberg & Knoop have previously co-authored papers where a score of 60 (the threshold for normal physical function) was regarded as severe impairment [8-11].
The normal range was not based on healthy people of working age only. For example, the normal range for physical function was based on a general population that included the elderly and chronically disabled [3]. If the normal range was based on a healthy population as asserted, the threshold for normal physical function would be 85 points or more, not 60 or more [6]. A preliminary re-analysis of recovery in the PACE trial, based on the protocol-specified recovery criteria, shows that the recovery rates in the CBT and GET groups were 6.8% and 4.4% respectively, and not significantly higher than with specialist medical care alone [7].
References
1) Bleijenberg G, Knoop H. Chronic fatigue syndrome: where to PACE from here? Lancet. 2011 Mar 5;377(9768):786-8. doi: 10.1016/S0140-6736(11)60172-4. Epub 2011 Feb 18. PMID: 21334060. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60172-4/fulltext
2) White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC, Baber HL, Burgess M, Clark LV, Cox DL, Bavinton J, Angus BJ, Murphy G, Murphy M, O'Dowd H, Wilks D, McCrone P, Chalder T, Sharpe M; PACE trial management group. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet. 2011 Mar 5;377(9768):823-36. doi: 10.1016/S0140-6736(11)60096-2. Epub 2011 Feb 18. PMID: 21334061. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3065633/
3) White PD, Goldsmith KA, Johnson AL, Walwyn R, Baber HL, Chalder T, Sharpe M, [on behalf of the coauthors]. The PACE trial in chronic fatigue syndrome — Authors' reply. The Lancet, Volume 377, Issue 9780, Pages 1834 - 1835, 28 May 2011 (Published Online: 17 May 2011). doi:10.1016/S0140-6736(11)60651-X http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60651-X/fulltext
4) http://www.pcc.org.uk/cases/adjudicated.html?article=ODQwOQ
5) Continuing Correspondence Between Countess of Mar and Professor Peter White and Professor Sir Simon Wessely. 26 January 2013. http://forums.phoenixrising.me/index.php?threads/continuing-correspondence-countess-of-mar-and-prof-white-and-prof-sir-s-wessely.21545/
6) Matthees A. Re: Tackling fears about exercise is important for ME treatment, analysis indicates. BMJ Rapid Response. 21 January 2015. http://www.bmj.com/content/350/bmj.h227/rr-16
7) Matthees A, Kindlon T, Maryhew C, Stark P, Levin B. A preliminary analysis of ‘recovery’ from chronic fatigue syndrome in the PACE trial using individual participant data. Virology Blog. 21 September 2016. http://www.virology.ws/wp-content/uploads/2016/09/preliminary-analysis.pdf
8) van't Leven M, Zielhuis GA, van der Meer JW, Verbeek AL, Bleijenberg G. Fatigue and chronic fatigue syndrome-like complaints in the general population. Eur J Public Health. 2010 Jun;20(3):251-7. Epub 2009 Aug 18. PMID: 19689970. http://eurpub.oxfordjournals.org/content/20/3/251.long
9) Tummers M, Knoop H, van Dam A, Bleijenberg G. Implementing a minimal intervention for chronic fatigue syndrome in a mental health centre: a randomized controlled trial. Psychol Med. 2012 Oct;42(10):2205-15. doi: 10.1017/S0033291712000232. Epub 2012 Feb 21. PMID: 22354999. http://www.ncbi.nlm.nih.gov/pubmed/22354999
10) Stulemeijer M, de Jong LW, Fiselier TJ, Hoogveld SW, Bleijenberg G. Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: randomised controlled trial. BMJ. 2005 Jan 1;330(7481):14. Epub 2004 Dec 7. doi: 10.1136/bmj.38301.587106.63. PMID: 15585538. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC539840
11) Heins M, Knoop H, Nijs J, Feskens R, Meeus M, Moorkens G, Bleijenberg G. Influence of symptom expectancies on stair-climbing performance in chronic fatigue syndrome: effect of study context. Int J Behav Med. 2013 Jun;20(2):213-8. doi: 10.1007/s12529-012-9253-2. PMID: 22865100. http://www.ncbi.nlm.nih.gov/pubmed/22865100
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