The 12th Invest in ME Research Conference June, 2017, Part 2
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PACE trial: Lancet Psychiatry paper on long term follow - correspondence

Discussion in 'General ME/CFS Discussion' started by charles shepherd, Jan 18, 2016.

  1. charles shepherd

    charles shepherd Senior Member

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    PACE trial: Lancet Psychiatry paper on long term follow up - correspondence

    The PACE trial long-term follow up letters and author responses are scheduled to go online at 23:30h UK time on Monday January 18th 2016

    There can be a slight delay as the Online First page updates.

    I understand that this correspondence will be free to access at http://www.thelancet.com/journals/lanpsy/onlinefirst

    Dr Charles Shepherd
    Hon Medical Adviser, MEA
     
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  2. Esther12

    Esther12 Senior Member

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    Thanks for writing in again Charles. Hopefully with Coyne and Laws having also written, it will be harder for the PACE lot to pull there usual BS.
     
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  3. jimells

    jimells Senior Member

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    I've been waiting impatiently all day for 23:30 to arrive - only one more hour! :D


    (Imagine how exciting it would be to see a live PACE Debate - Dr Tuller and Dr Coyne vs Dr Sir Simon and Dr White - I'd definitely make popcorn for that)
     
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  4. Kati

    Kati Patient in training

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    I hope people who can read them can copy them on this thread. My ipad can't open anything from the Lancet.
     
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  5. halcyon

    halcyon Senior Member

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    Your iPad must have been deemed vexatious.

    25 more minutes!
     
  6. Esther12

    Esther12 Senior Member

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    I wouldn't get over-excited by this... PACE are clearly going to pull out some evasive BS, even if they're not going to be so able to condemn letter writers for daring to point out their spin.
     
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  7. Sasha

    Sasha Fine, thank you

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    Well, I don't know... I think there's a limit to how much BS they can pull that's actually persuasive, in the face of receiving critique from some actual professors this time, rather than "just" patients.

    Could be interesting...
     
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  8. halcyon

    halcyon Senior Member

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    They're on their home turf here though. I think it's going to be business as usual from the PACE folks. As @Esther12 said we probably shouldn't get too excited, but it is nice to keep the momentum going as I feel like we lost major steam on all the PACE stuff after the holidays.
     
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  9. Sasha

    Sasha Fine, thank you

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    Not sure a journal can really be considered anybody's turf, though - it's there for all to see and if they're talking rubbish they'll be doing it very publicly at this point - a lot of eyes are on them that haven't been in the past.

    Lots of good PACE stuff upcoming - the FOI request that Ron Davis, David Tuller and the others put in has its response date any day now, and PLOS One's lawyers are on the case with James Coyne's data request... and there's that patient who's got an FOI going to tribunal...
     
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  10. Esther12

    Esther12 Senior Member

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    They're 30 seconds late!!!!!

    The recent Keith Laws blog showed some poor responses to academics in a journal.
     
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  11. jimells

    jimells Senior Member

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    But you don't understand... my life is very boring, so watching the PACE People get beatup is cheap entertainment for me, and I don't even have to leave the couch. :D
     
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  12. daisybell

    daisybell Senior Member

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    And it's up....!
     
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  13. charles shepherd

    charles shepherd Senior Member

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    Last edited: Jan 18, 2016
  14. Sasha

    Sasha Fine, thank you

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  15. charles shepherd

    charles shepherd Senior Member

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    Letter 1: Dr Charles Shepherd

    The long-term follow-up of the PACE trial,1 which originally reported that cognitive behavioural therapy (CBT) and graded exercise therapy (GET) produced a significant and sustained improvement, even recovery, for some people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)2 should, in theory, have been greeted positively by patients. However, Michael Sharpe and colleagues1 found very little difference in outcomes at long-term follow-up between any of the four interventions (which also included adapted pacing therapy and specialist medical care) and the patient community has expressed both anger and despair.

    Anger because the media, along with many health professionals, has concluded that people can recover from ME/CFS through a simplistic approach to management involving exercise and positive thinking.3 Despair because the findings from the PACE trial have not been supported by patient evidence on CBT, GET, and pacing, which dates back to the 2002 Chief Medical Officer's Working Group report4 on ME/CFS.

    The largest and most recent survey5 of patient evidence on the acceptability, efficacy, and safety of CBT, GET, and pacing was carried out by The ME Association and involved 1428 respondents. In this case, 73% of respondents reported that CBT had no effect on their symptoms and 74% that their symptoms were made worse by GET.

    As a result, The ME Association has recommended that the National Institute for Health and Care Excellence should withdraw their recommendation that everyone with mild or moderate ME/CFS should be offered GET. And while accepting that some people may find CBT helpful when there are comorbid mental health problems, as can occur with any long-term condition, we believe that CBT should not be used as a primary intervention.

    A report from the National Institutes of Health Pathways to Prevention Workshop6 also concluded that CBT and GET should not be used as a primary treatment strategy in ME/CFS.

    The patient community feels so strongly about this issue that a petition7 asking for the retraction and correction of various parts of the PACE trial has gathered over 10 000 signatures.

    The argument here is not with psychiatry. Mental illness is just as real and horrible as physical illness, and as with any long-term illness, some people with ME/CFS develop comorbid depression and other mental health problems. The argument is with a flawed model of causation that takes no account of the heterogeneity of both clinical presentations and disease pathways that come under the umbrella diagnosis of ME/CFS along with the conclusion that CBT and GET should to be used as one size fits all primary interventions for everyone with mild or moderate symptoms.

    The only way to conclude if people on the PACE trial have recovered from ME/CFS is to re-interview them to confirm they are symptom free; have returned to normal health and functioning; have resumed any education or employment preceding the illness, and have ceased to claim any disability benefits.

    Without robust objective evidence relating to improvement and recovery, the ME patient community will continue to regard the PACE trial as a tremendous waste of research funding money.

    I am Medical Adviser of the ME Association. I declare no other competing interests.

    References
    1. Sharpe, M, Goldsmith, KA, Johnson, AL et al. Rehabilitative treatments for chronic fatigue syndrome: long-term follow-up from the PACE trial. Lancet Psychiatry. 2015; 2: 1067–1074
    2. 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. Lancet. 2011; 377: 823–836
    3. Knapton, S. Chronic fatigue syndrome sufferers can overcome symptoms of ME with positive thinking and exercise. Daily Telegraph (London), Oct 28, 2015.http://www.telegraph.co.uk/news/hea...f-ME-with-positive-thinking-and-exercise.html.
    4. Department of Health. A report of the CFS/ME working Group: report to the chief Medical Officer of an Independent Working Group. Department of Health, London;2002http://www.meassociation.org.uk/wp-content/uploads/CMO-Report-2002.pdf. ((accessed Nov 18, 2015).)
    5. The ME Association. ME/CFS Illness Management Survey Results. “No decisions about me without me”. http://www.meassociation.org.uk/how-you-can-help/fundraising-support/. ((accessed Nov 18, 2015).)
    6. Green, CR, Cowan, P, Elk, R, O'Neil, KM, and Rasmussen, AL. National Institutes of Health Pathways to Prevention Workshop: advancing the research on myalgic encephalomyelitis/chronic fatigue syndrome. Ann Intern Med. 2015; 162: 860–865
    7. ME Action. Misleading pace claims should be retracted. http://my.meaction.net/petitions/pace-trial-needs-review-now. ((accessed Nov 18, 2015).)

    Letter 2: Frank Twisk (Holland)

    In a recent Article Michael Sharpe and colleagues1 report on findings of a follow-up study of the PACE trial of proposed rehabilitative interventions for chronic fatigue syndrome: graded exercise therapy (GET) and cognitive behavioural therapy (CBT). Their main finding is that the beneficial effects of CBT and GET were maintained at follow-up (median: 2·5 years).1 Both CBT and GET have been qualified by the PACE trial investigators as “moderately effective treatments”.2 However, looking at the data of the follow-up study1 and other PACE trial studies,2, 3 CBT and GET do not qualify as rehabilitative therapies for chronic fatigue syndrome or myalgic encephalomyelitis, as defined by the London criteria.1

    First, the PACE trial investigated the effects of CBT and GET in chronic fatigue, as defined by the Oxford criteria, not in chronic fatigue syndrome, let alone myalgic encephalomyelitis, as defined by the Ramsay criteria.4 The Oxford criteria have been criticised often. For that reason “consensus groups and researchers should consider retiring the Oxford case definition”.4

    Second, the positive effect of CBT and GET in subjective measures, fatigue and physical functioning, cannot be qualified as sufficient. Mean short form-36 physical functioning scores in the CBT group (62·2) and the GET group (59·8) at follow-up were below the inclusion cutoff score for the PACE trial (≤65)3 and far below the objective for recovery as defined in the PACE protocol (≥85).5 The mean fatigue scores in the CBT group (18·4) and GET group (19·1) were above subnormal (<18)4 and far above the entry criterion for the PACE trial (>12, recalculated)3 and the recovery criterion in the PACE protocol (≤6).5

    Third, the PACE trial follow-up study1 concluded that outcomes with specialist medical care alone or adaptive pacing therapy (APT) were similar to CBT and GET at follow-up. The authors suggest that ”it is important to note that many of the participants had received additional treatment for CFS since completing the trial”. Looking at the data,1 23 (20%) of the patients in the specialist medical care arm received an adequate number of sessions (n=10) of CBT after the PACE trial and 14 (12%) received GET, while 20 (17%) of the patients in the APT group received CBT and 7 (6%) received GET afterwards. This finding implies that the vast majority of patients improved subjectively by specialist medical care and APT to the same level as by CBT and GET, without any additional therapies, including CBT and GET, or by other therapies.1

    Finally, looking at subjective outcomes at follow-up1 and objective outcomes in earlier studies, such as physical fitness,2 return to employment,3 social welfare benefits,3 and health-care usage,3 CBT and GET, like specialist medical care and APT, cannot be qualified as effective.

    In conclusion, CBT and GET are moderately effective in subjective terms in chronic fatigue, but looking at the patients studied and the (subjective and objective) outcomes of the PACE trial,1, 3, 4, 5CBT and GET do not meet the requirements for rehabilitative or effective therapies for chronic fatigue syndrome, let alone myalgic encephalomyelitis.

    I am associated with a Dutch ME/CFS patient foundation in a voluntary (non-paid) capacity.

    References
    1. Sharpe, M, Goldsmith, KA, Johnson, AL, Chalder, T, Walker, K, and White, PD. Rehabilitative treatments for chronic fatigue syndrome: long-term follow-up from the PACE trial. Lancet Psychiatry. 2015; 2: 1067–1074
    2. Twisk, F. Post-exertional malaise in chronic fatigue syndrome. Lancet Psychiatry. 2015; 2: e8–e9
    3. McCrone, P, Sharpe, M, Chalder, T et al. Adaptive pacing, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome: a cost-effectiveness analysis.PLoS One. 2012; 7: e40808
    4. Haney, E, Smith, ME, McDonagh, M et al. Diagnostic methods for Myalgic Encephalomyelitis/chronic fatigue syndrome: a systematic review for a national institutes of health pathways to prevention workshop. Ann Intern Med. 2015; 162: 834–840
    5. White, PD, Sharpe, MC, Chalder, T, DeCesare, JC, Walwyn, R, and 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 Neurol. 2007; 7: 6

    Letter 3: James Coyne and Frank Laws (USA)

    The PACE follow-up study1 is something of a curate's egg, admirable in ambition, but interpretatively indigestible. Although the PACE programme of cognitive behavioural therapy (CBT) or graded exercise therapy (GET) led patients to report less fatigue or greater physical function than patients in the adaptive pacing therapy and specialist medical care groups in the short term, evidence in the long-term follow-up is unconvincing. The lack of between-group differences at follow-up takes precedence over within-group differences, which are inflated by attribution of any change associated with non-specific factors to the specific interventions. Re-assignment to new treatment also makes between-group comparisons uninterpretable, as we will see.

    Although the investigators made heroic efforts to correct for attrition using linear mixed-effects regression models, such efforts depend on their unjustified assumptions of random missing data and of treatment received at follow-up not distorting any signal of effects of the earlier randomisation. Various covariates are introduced for statistical control, but without adequate rationale and documentation of diagnostics. It is therefore doubtful that the complexly adjusted results are reliable.

    Several other unfortunate decisions further undermine the findings. Foremost, the unregulated crossover between treatments during follow-up. The follow-up outcome data1 in table 3 and figure 2 are uninterpretable because they refer to initial randomisation, without reflecting the—quite different treatments—received during follow-up.

    The authors argued: “In so far as the need to seek additional treatment is a marker of continuing illness, these findings support the superiority of CBT and GET as treatments for chronic fatigue syndrome”.1 More participants in the specialist medical care alone and the adaptive pacing therapy (APT) groups received additional treatments during follow-up than did those in the CBT and GET groups, but this finding is hardly surprising when half of participants in the specialist medical care group rated it as not being a logical treatment for them and only 41% were confident about being helped by specialist medical care.1 This lack of equipoise was facilitated by the initial description of treatments investigators offered to patients and compounded by a mid-trial Newsletter for patients praising the PACE interventions. It is easy to see how specialist medical care effectively became a waitlist control of frustrated sufferers, who naturally awaited re-assignment. This limitation casts doubts not only on the validity of the follow-up data, but on the integrity of the trial itself.

    Putting doubts about the validity of the PACE follow-up aside, let's take a close look at the unadjusted physical functioning follow-up data in figure 2.1 There are no group differences, and the overall mean short-form 36 (SF-63) physical functioning score is less than 60. It is useful to put this number in context. 77% of the PACE trial participants were women, and the mean age of the trial population was 38 years, with no other disabling medical conditions. Patients with lupus have a mean physical functioning score of 63,2 patients with class II congestive heart failure have a mean score lower than 60,3 and normal controls with no long-term health problems have a mean score of 93.4

    Lastly, the PACE investigators have previously complained in The Lancet Psychiatry of “the apparent campaign to bring the robust findings of the trial into question”.5 We think the further scrutiny that the follow-up study has brought casts further doubt on whether there ever were “robust findings”. The investigators should get more accustomed to rigorous post-publication peer review, which is not a campaign, but a reality of the 21st century.

    We declare no competing interests.

    References
    1. Sharpe, M, Goldsmith, KA, Johnson, AL, Chalder, T, Walker, J, and White, PD. Rehabilitative treatments for chronic fatigue syndrome: long-term follow-up from the PACE trial. Lancet Psychiatry. 2015; 2: 1067–1074
    2. Tench, CM, McCurdie, I, White, PD, and D'Cruz, DP. The prevalence and associations of fatigue in systemic lupus erythematosus. Rheumatology. 2000; 39: 1249–1254
    3. Juenger, J, Schellberg, D, Kraemer, S et al. Health related quality of life in patients with congestive heart failure: comparison with other chronic diseases and relation to functional variables. Heart.2002; 87: 235–241
    4. 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. J Pub Health. 1999; 21: 255–270
    5. Chalder, T, Goldsmith, KA, White, PD, Sharpe, M, and Pickles, AR. Methods and outcome reporting in the PACE trial–Author's reply. Lancet Psychiatry. 2015; 2: e10–e11
     
  16. charles shepherd

    charles shepherd Senior Member

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    Authors reply to all three letters:

    The original PACE trial Article1 reported that the rehabilitative treatments of cognitive behaviour therapy (CBT) and graded exercise therapy (GET) produced a greater improvement in fatigue and physical function for patients with chronic fatigue syndrome than did adaptive pacing therapy (APT) or standard medical care alone, when measured at the trial final outcome 1 year after randomisation. We used a standard research definition of chronic fatigue syndrome (Oxford Criteria) for entry to the trial; we found similar results in the subgroup analyses for other definitions of chronic fatigue syndrome and of myalgic encephalomyelitis. Self-rated measures of fatigue and physical function were chosen as primary outcomes because chronic fatigue syndrome is diagnosed by self-report (in the absence of an alternative diagnosis) and we therefore considered these to be the best way to measure improvement. The trial was rigorously conducted and closely monitored. As our collaborators in the research, trial participants received regular newsletters approved by the research ethics committee, which covered a variety of relevant topics. As noted, one of thesenewsletters included positive quotes from participants. Since these participants were from all four treatment arms (which were not named) these quotes were neither evidence of lack of equipoise nor a source of bias, as suggested by James Coyne and Keith Laws.

    Our more recent Article reporting long-term patient outcomes2 found that improvement was maintained for those originally allocated to CBT or GET. While recovery for all participants receiving these treatments has never been claimed, a mean improvement of approximately 20 points on the medical outcomes study short-form 36 (SF-36) physical functioning scale from trial entry is, contrary to Frank Twisk's comments about the lack of treatment effect, clearly clinically meaningful. Nor is its value to patients negated by Coyne and Laws' reference to mean SF-36 scores from selected cross-sectional studies of patients with other illnesses.

    Participants allocated to APT or standard medical care alone in the trial showed poorer outcomes at 12 months. However, the outcomes reported by those who received these treatments in the trial and participated in the follow-up study had improved to the extent that, in a comparison of long-term outcomes by original trial treatment allocation, we found few differences. Although this finding might mean that all PACE treatments have similar long-term outcomes, we cannot draw this conclusion. This is because, as explained in the Article,2 the follow-up study was not, as suggested by Coyne and Laws, a continuation of the trial (with or without crossover), but rather a naturalistic follow-up after trial completion. During this follow-up period, more than half of participants originally allocated to standard medical care alone and to APT sought at least some treatment with CBT or GET. Consequently, the long-term outcome in these participants is not of standard medical care alone or APT alone, but of these therapies supplemented in many cases by CBT or GET. Furthermore, we know that the seeking of such additional therapy was not, as suggested, merely a response to getting only standard medical care, because participants who had been allocated to APT (which offered the same contact time as CBT and GET and was rated as at least as logical by participants) also frequently sought it.

    The statistical analysis accounted for missing data using linear mixed effects models and made the missing-at-random assumption. These are widely accepted approaches, given that missing data assumptions cannot be properly tested; the missing-at-random assumption was acknowledged as a potential limitation in the Article.2 The rationale for including the missing data predictors was stated in the Article and makes the missing-at-random assumption more plausible. The covariates were either stratification factors or chosen as significant predictors in a model with lack of data as the dependent variable.

    As highlighted by Charles Shepherd, the findings of the PACE trial and follow-up study differ from those of a patient association membership survey,3 which reported that CBT and GET were unhelpful and even harmful. Although of interest, these survey findings do not negate the results of the trial. There are many possible reasons for the difference between the survey and our results. First, inclusion in the trial was based on a diagnostic assessment for chronic fatigue syndrome, whereas we cannot be confident of the diagnoses of survey participants identified simply by being a member of a patient association.4 The treatments given in the trial were rigorously monitored for quality, whereas we know little about the treatment reported on in the survey and do know that in clinical practice treatment may be mislabelled or poorly delivered.5 The trial had a good follow-up rate, whereas we know that surveys with an unknown sample and response rate, as is the case with this survey, are subject to bias.

    Finally, we respectfully point out that disagreeing with the findings of a research study does not necessarily mean that the study is flawed. The marked antipathy of some toward this study, apparent in the correspondence and elsewhere, is perhaps related in part to the view, expressed by Shepherd, that the findings support “a simplistic and flawed model of psychosocial causation”. They do not. They do, however, offer practical hope of useful improvement, a finding reinforced from the routine monitoring of the outcomes of the many patients who attend clinics that offer these and similar treatments.6

    PDW has done voluntary and paid consultancy word for the UK Government and a reinsurance company. TC has received royalties from Sheldon Press and Constable and Robinson. MS has received royalties from Oxford University Press. KAG and JW declare no competing interests.

    References
    1. White, PD, Goldsmith, KA, and Johnson, AL. 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; 377: 823–836
    2. Sharpe, M, Goldsmith, KA, Johnson, AL et al. Rehabilitative treatment for chronic fatigue syndrome: long-term follow up from the PACE trial. Lancet Psychiatry. 2015; 2: 1067–1074
    3. ME Association. ME/CFS illness management survey results. “No decisions about me without me”.http://www.meassociation.org.uk/wp-...No-decisions-about-me-without-me-30.05.15.pdf. ((accessed Jan 5, 2016).)
    4. Brimmer, DJ, Maloney, E, Devlin, R et al. A pilot registry of unexplained fatiguing illnesses and chronic fatigue syndrome. BMC Res Notes. 2013; 6: 1–11
    5. Gladwell, PW, Pheby, D, Rodriguez, T, and Poland, F. Use of an online survey to explore positive and negative outcomes of rehabilitation for people with CFS/ME. Disabil Rehabil. 2014; 36: 387–394
    6. Crawley, E, Collin, SM, White, PD, Rimes, K, Sterne, JAC, and May, MT. Treatment outcome in adults with chronic fatigue syndrome: a prospective study in England based on the CFS/ME National Outcomes Database. QJM. 2013; 106: 555–565
     
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  17. lansbergen

    lansbergen Senior Member

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    That would be great if it could be done by people not involved in the PACE trial
     
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  18. Keela Too

    Keela Too Sally Burch

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    So am I missing something... what is happening regarding the release of the data?
     
  19. Esther12

    Esther12 Senior Member

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    tbh, my main response is: the 500 word limit makes it really difficult to have a proper debate in Lancet Psych. A shame the PACE researchers didn't want to go through with the Mental Elf thing.

    If I was reading that without prior knowledge, I don't think that I'd be able to conclude much from the exchange.

    Would have been nice to have had some more critical letters in to cover more issues, but can understand people who wrote last time not bothering after PACE's last response. Thanks to all those who did write in. All letter raised important points, and I think that having Coyne and Laws write should also be really helpful for encouraging people to at least consider whether concerns' about PACE might have some merit.

    Nothing new from the PACE crew.
     
    Last edited: Jan 18, 2016
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  20. jimells

    jimells Senior Member

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    From Dr Shepherd's letter:

    :thumbsup:

    Oh, I see I crossed posts with Dr Shepherd...
     
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