Anomalies in the review process and interpretation of the evidence in the NICE guideline for (CFS & ME), 2023, White et al

Thought -
Interesting that the authors quoted Cochrane* i.e. in dealing with the issue of lack of objective outcome criteria in trials. I recall someone advising that it's often easier to accept the other person's evaluation criteria [Cochrane in this case] and just point out that they applied these criteria incorrectly. Here they've pointed out that Cochrane downgrades for subjective outcome criteria [bold, underlined, italic text].
Apologies for my lack of clarity!
[EDIT] - I like the fact that they've highlighted that the objective outcome data "indicated no clinically relevant improvements".
Thanks to the authors.

"
2. Blinding and subjective outcomes
White et al. write: “The NICE committee decided to downgrade all fatigue outcomes based on the premise that it is a subjective measure.” This is incorrect. Fatigue outcomes in studies with a low risk of bias such as the double-blind Rituximab trial were not downgraded.

NICE did downgrade quality of evidence when subjective outcomes (not just fatigue, but also pain, sleep, quality of life, etc.) were used in trials where participants and therapists were not blinded as this combination creates a high risk of bias. This grading is in accordance with the Cochrane Handbook which states that “the potential for bias cannot be ignored even if the outcome assessor cannot be blinded." (2) In the case of patient-reported outcome measures such as fatigue, the Cochrane Handbook considers patients to be the outcome assessor.

Moreover, trials of GET and CBT also included objective measurements such as fitness tests, actigraphy, and employment data and these indicated no clinically relevant improvements. (3)

 

Not sure about the whole comment, but the 'balance' bit seems most problematic to me, too. Balance is not needed to have patients' wellbeing at one's heart.

Perhaps NICE was surprised that listening to well-chosen patient representatives actually helped assess the evidence, and this evidence didn't contradict much of patients' experience?

Those clinician researchers though who prefer to believe their own experience and in their own questionable research practices instead and did not listen to patients' and their allies' reasonable critique now have to learn that also by common standards their research isn't good enough to back up their beliefs.

Also, those who can't accept the rigorous assessment of their own research and beliefs have to learn that research in their area could have been so much better if they had listened to their patients' and others' critique.

If they had listened, they could have learned a while ago that only because you belief reliable objective outcome measures in your specialist field don't exist, there is no exception to the rule that using only subjective outcomes in unblinded trials is a combination that has a too high risk of bias to be useful.

They could have learned which treatment outcomes matter to people with ME and they could have tried to develop better outcome measures.


(Apologies for multiple edits.)

 

The irony is that the whole BPS approach relies on believing patients if they say they feel a bit better following therapy, but dismissing us as unreliable witnesses to our own illness experiences in almost all other contexts.

 

Even with the huge imbalance between both groups. They are choosing to harm most of us in order to feel like they helped a few, most of which would have likely improved on their own anyway. Usually the concern over first do no harm is that it's even unacceptable to harm a few in order to help most, or the balance has to be extreme.

And at the very best the "helping" part can be defined as 1/7 have some form of subjective benefit with no objective evidence. It's so grotesque that people simply don't believe it when we expose the simple facts. This has all been extremely immoral.

 

New, non-discussion thread I have just set up:

(No discussion) E-letters submitted to JNNP replying to White et al. "Anomalies in the review process & interpretation of the evidence in the NICE..."
https://www.s4me.info/threads/no-di...rpretation-of-the-evidence-in-the-nice.34704/

FYI @rvallee @Joan Crawford

 

The journal website has just posted an e-letter in reply to a different paper https://jnnp.bmj.com/content/early/...ry-mode-and-development-of-multiple-sclerosis . It looks like it was submitted on August 9. It doesn’t look good for e-letters replying to the Anomalies paper submitted before that date, though possibly they are awaiting approval from a senior editor.

 

Trial By Error: Rapid Response to Anti-NICE Whine de Coeur; UK Government Seeks Input to Interim Delivery Plan for ME/CFS

"The Journal of Neurology, Neurosurgery, and Psychiatry (JNNP) has finally published a cogent rapid response to its recent whine de coeur from the PACE authors and their cronies. In the commentary, the co-authors criticized eight purported “anomalies” they believe occurred during the process of developing the 2021 ME/CFS guideline from Britain’s National Institute for Health and Care Excellence (NICE). Although a number of rapid responses are known to have been sent, this is the first one JNNP has decided to share

More accurately, it’s the first except for the rapid response from MEAction UK that was shared by JNNP–and then quickly un-shared. (I wrote about that here.) In a statement, the journal attributed the decision to disappear the rapid response to “inappropriate inflammatory language” that had apparently not been inflammatory enough to prevent the initial posting. At least TheBMJ.com ran a news item about the commentary–JNNP is one of the journals under the BMJ publishing umbrella—and then published a response to the news report from Dr Charles Shepherd, medical advisor to the ME Association."

https://virology.ws/2023/08/14/tria...ks-input-to-interim-delivery-plan-for-me-cfs/

 

I wonder if there is any value in submitting those rapid responses that weren't printed by the JNNP to the BMJ as a response to the news article?

 

@rvallee has now posted his e-letter here
https://www.s4me.info/threads/no-di...f-the-evidence-in-the-nice.34704/#post-489350 which disappointingly has not been posted by the JNNP on their website

 

With 12,900 odd followers I’ve quite a big following and have shared:

I saw last week the @mecfsnews account also linked to the thread. The more, the merrier

 

I just went to look for the PubPeer link where people can post post publication comments and found this one by Peter White (a different Peter White to the one who was lead author of the anomalies paper).

It starts:

The following points were submitted in a short Rapid Response but not published. The JNNP has stated that they took-down Rapid Reponses because of ‘inappropriate inflammatory language’. This reply includes more detail than the Rapid Response, but is similar in tone.

In Brief:
• White et al’s assertion that Post-Exertional Malaise is a new requirement in the 2021 NICE guideline is false. Post-Exertional Malaise was required in the previous 2007 NICE guideline.
• White et al’s assertion that, in trials, Graded Exercise Therapy was “only increased as the patient feels able, dependent on their symptomatic response”, is also false, see Moss-Morris (2005).
• There is a systemic under-reporting and dismissal of patient reports of harm across all medical fields. Dismissal of reports of harm repeats mistakes of other devastating medical scandals as evidenced by the UK Govt ‘Cumberledge Review’ published in 2020.


Continues at:

https://pubpeer.com/publications/95FD14B92656A4AD5498AD9928930C

 

PubMed Commons was a great resource for posting such comments. Also comments were prominent as they were on the PubMed website. I spent quite a bit of time over an extended period posting over 100 of my e-letters only for the project to be scrapped after a few years as not enough were posted. PubPeer did plan to copy across the responses (I discovered this after I had already copied across a lot of mine).

 

Great letter @rvallee

 

You can get a PubPeer extension for Chrome which highlights when there are responses on PubPeer.
See the images attached.
I have no idea how many people have it.