Is NICE losing its standing as a trusted source of guidance? 2023, Jonathan A Michaels, honorary professor of clinical decision science

[Sly Saint]

Recommendations must better reflect societal values and preferences

The National Institute for Health and Care Excellence (NICE) develops healthcare guidance for the NHS, aiming to provide “the best care for patients, while ensuring value for the taxpayer.”1 Restricting access to effective healthcare on economic grounds is always controversial, and guideline authorities differ considerably in how they incorporate economic evidence into recommendations.2

NICE has been at the forefront of developing methods for economic evaluation,3 but recent recommendations have led to conflict with clinicians. For example, when draft aneurysm guidance proposed limiting access to new minimally invasive treatments on cost effectiveness grounds, clinical opposition resulted in NICE over-ruling its advisory committee.4 NICE’s rejection of graded exercise therapy for myalgic encephalomyelitis/chronic fatigue syndrome has been challenged by many specialists.5 These controversies may be the result of increasingly complex methods that fail to fully incorporate societal values and preferences.

From the start, NICE chose cost per quality adjusted life year (QALY) as the basis for its economic evaluations, while giving committees flexibility to account for effects of healthcare …

paywalled
https://www.bmj.com/content/383/bmj.p2571.full

 

[Trish]

The author is at the University of Sheffield which is where Christopher Burton and Vincent Deary are based who do awful stuff about MUS. We protested about Burton's appointment to the NICE committee and I think he was one of the ones who publicly resigned after the guideline had been agreed.
S4ME Letter to Nice Concerning Chris Burton

It seems likely to me that this article is part of the coordinated ongoing battle to have the NICE guideline recommendation about CBT/GET reversed. This time by trying to discredit NICE.

If anyone has access to the full text, I'd like to see it please.

 

[DokaGirl]

From the article:

"...rejection of GET challenged by many specialists"

First, I would question how many specialists have challenged this new guideline on ME. Is it a great number, or a vocal few repeatedly expressing their dissatisfaction?

Challenges to this new guideline are doubtless coming from practitioners who were taught ME does not exist, or is a psychological condition. They may not be aware of any biomedical findings re this physiological disease. This is like making any uneducated choice.

As we are well aware challenges to the new NICE guidelines also come from the BPS Movement, where graded exercise therapy and cognitive behaviour therapy are the bread and butter treatments prescribed for ME, a debilitating biomedical disease. A disease with the hallmark symptom post-exertional malaise (PEM).

 

[Jonathan Edwards]

The author is at the University of Sheffield which is where Christopher Burton and Vincent Deary are based
It seems likely to me that this article is part of the coordinated ongoing battle to have the NICE guideline recommendation about CBT/GET reversed.

If anyone has access to the full text, I'd like to see it please.

Yes, I suspect a link to Burton. I have seen the full piece and will try to pull it out. It is pretty pathetic. Beyond the snippet given as abstract it Seays pretty little. ME is not mentioned again. No evidence is presented, simply the fact that NICE disagrees with some professional bodies. The claim that NICE ignore societal issues is a joke since the ME guideline arose precisely because societal issues were taken seriously. Moreover, those whining about the result blame it on too much societal input and not enough attention to assessment rules!

 

[Jonathan Edwards]

First, I would question how many specialists have challenged this new guideline on ME. Is it a great number, or a vocal few repeatedly expressing their dissatisfaction?

A lot of medical professionals, psychologists and physios have challenged the guideline although BACME has fallen in line. But the numbers simply reflect how many professionals have vested interests in a quiet life, or alternatively a busy practice in therapy. Nothing whatever to do with societal issues or cost-effectiveness.

 

[Jonathan Edwards]

Is NICE losing its standing as a trusted source of guidance?
BMJ 2023; 383 doi: https://doi.org/10.1136/bmj.p2571 (Published 08 November 2023)Cite this as: BMJ 2023;3832571

1. Jonathan A Michaels, honorary professor of clinical decision science

1. 
   Author affiliations

1. j.michaels@sheffield.ac.uk

Recommendations must better reflect societal values and preferences

The National Institute for Health and Care Excellence (NICE) develops healthcare guidance for the NHS, aiming to provide “the best care for patients, while ensuring value for the taxpayer.”1 Restricting access to effective healthcare on economic grounds is always controversial, and guideline authorities differ considerably in how they incorporate economic evidence into recommendations.2

NICE has been at the forefront of developing methods for economic evaluation,3 but recent recommendations have led to conflict with clinicians. For example, when draft aneurysm guidance proposed limiting access to new minimally invasive treatments on cost effectiveness grounds, clinical opposition resulted in NICE over-ruling its advisory committee.4 NICE’s rejection of graded exercise therapy for myalgic encephalomyelitis/chronic fatigue syndrome has been challenged by many specialists.5 These controversies may be the result of increasingly complex methods that fail to fully incorporate societal values and preferences.

From the start, NICE chose cost per quality adjusted life year (QALY) as the basis for its economic evaluations, while giving committees flexibility to account for effects of healthcare not adequately captured by QALYs.6 Later revisions of NICE methods account for disease rarity and disease severity, and reward innovation, by introducing modifiers that weight QALY outcomes7 or by altering acceptable thresholds.8 However, other aspects of healthcare that are also important to patients, service users, and healthcare professionals are not currently quantified, including processes of care, and attributes such as fairness, dignity, accessibility, inclusivity, autonomy, and human interaction.9

Adverse influence
The healthcare industry, with its technical expertise and extensive resources, may be more influential than societal interests in shaping NICE methods and determine many of the value judgments used in setting the research agenda, designing studies, interpreting findings, and selecting and submitting evidence to regulators.10NICE methods and decisions may also be influenced directly11 or indirectly12 by political priorities. Treatments less amenable to randomised trials, or those without commercial potential, may be disadvantaged through the lack of robust evidence, while NICE has been criticised for approving costly drugs, such as inclisiran, on the basis of lifetime extrapolations from the short term proxy outcomes provided by industry.13

Incremental development of NICE methods has resulted in thousands of pages of highly technical advice and increasing reliance on quantitative methods. This technical complexity may promote consistent and transparent numerical estimates, unless there is extensive redaction of information deemed commercially sensitive,14 but it also obscures the implicit value judgments underpinning technology evaluations. Furthermore, reliance on quantitative methods may overemphasise outcomes that are easier to measure.

For NICE to retain or regain its position as a respected source of advice for patients and healthcare professionals it must ensure that guidance is accepted as legitimate and independent. Both require that value judgments underpinning its advice are transparent and reflect societal preferences. NICE previously used a citizens’ council to advise on these matters. But their recommendations on social value judgments have now been replaced by a statement of procedural principles,15 and the council’s previous recommendations against using QALY adjustments for innovation16 or disease severity17 do not seem to be reflected in current methods. After a hiatus, the council has been replaced by a new programme of public engagement called “NICE listens.”18Importantly, this public engagement must be seen to consider and influence the complex value judgments embedded in NICE guidance and not become a box ticking exercise.

These challenges have practical implications for patients and service users. In a resource limited healthcare system such as the NHS there is an opportunity cost associated with every treatment recommendation. For example, the premium paid for highly specialised technologies19 could be used to alleviate ambulance waits, prevent the indignity of patients being treated in corridors, or provide the staff and facilities necessary for meaningful shared decision making or compassionate end-of-life care.

Regaining and maintaining trust
NICE must also ensure that its recommendations don’t jeopardise the position of healthcare professionals as trusted advisers. NICE claims that its guidance supports shared personalised decision making.20 Problems occur, however, when NICE recommendations prioritising cost effectiveness conflict with other guidance taking different perspectives. For example, NICE asthma guidelines caused confusion in 2018 when a recommendation on leukotriene receptor antagonists—on cost-effectiveness grounds— conflicted with guidance from the British Thoracic Society.21 Patients will naturally prioritise clinical outcomes over cost, making it difficult for clinicians to implement non-mandatory recommendations based on cost, without betraying patients’ trust.22

Clinicians, patients, and the public must be able to trust that NICE guidance will not prevent healthcare professionals from recommending the best available treatment that aligns with patients’ circumstances and preferences. They must also trust that recommendations are not only evidence based but reflect overall societal values and preferences, rather than commercial or political interests. Ultimately, if NICE is to achieve its objective of providing value for money for the taxpayer its methods must transparently identify and incorporate all attributes of healthcare that are valued by society.

Footnotes

• Competing interests: The BMJ has judged that there are no disqualifying financial ties to commercial companies. JM is contributing to research at the University of Sheffield funded by NIHR, is an unpaid independent member of steering and data monitoring committees for non-commercial studies, and has previously served as vice chair of the NICE appraisal committee and chair of a NICE guideline development group.
  
  
• Provenance and peer review: Commissioned; not externally peer reviewed.
  

References

1. National Institute for Health and Care Excellence. What we do. 2023. https://www.nice.org.uk/about/what-we-do
2. Sanabria AJ, Kotzeva A, Selva Olid A, et al. Most guideline organizations lack explicit guidance in how to incorporate cost considerations. J Clin Epidemiol2019;116:72-83.doi:10.1016/j.jclinepi.2019.08.004. pmid:31430507
   CrossRefPubMedGoogle Scholar
3. Sculpher M, Palmer S. After 20 years of using economic evaluation, should NICE be considered a methods innovator?Pharmacoeconomics2020;38:247-57. doi:10.1007/s40273-019-00882-6. pmid:31930460
   CrossRefPubMedGoogle Scholar
4. Campbell B. Balancing the evidence for guidelines: lessons from the NICE abdominal aortic aneurysm guidance—an essay by Bruce Campbell. BMJ2020;370:m3480. doi:10.1136/bmj.m3480. pmid:32972977
   FREE Full TextGoogle Scholar
5. Mahase E. ME/CFS: Researchers question credibility of NICE guidance. BMJ2023;3821621.doi:10.1136/bmj.p1621. pmid:37442579
   FREE Full TextGoogle Scholar

 

[Jonathan Edwards]

I think the reference to researchers complaining about ME guidelines is just to the journalist's piece about the letter from White and Co.

It is disappointing that this is an editorial. Editorials can be used for individual opinions but in this situation it has to be seen as endorsed by BMJ editorial office.

This is the anti-pharma lobby digging its oar in, or in other words one lot of piggies complaining about other piggies getting their snouts in the trough. NICE has traditionally been very stingy in relation to expensive drugs, using all sorts of spurious arguments to cut costs. It is perhaps ironic that it is perceived to be favouring industry now when the government is making sure funds are cut even further. The Mad Hatter's Tea Party rules. (not a reference to any political entity!)

 

[rvallee]

Adapting the well-known quote used in the legal profession:

If the facts are against you, argue the evidence. If the evidence is against you, argue the facts. If the evidence and the facts are against you, pound the table and yell like hell.

This is just yelling. The facts and evidence have always been against them, but this ideology managed to plow through for decades by pounding the table and yelling something about knowing better. It was always wrong thrice over: on the facts, on the evidence, and on not caring about either.

Literally all of this is just old medical mythology that was never put to an end, as should have happened long ago. Working like this, against facts and evidence, never works out in the end. It's terribly sad that the institutions of medicine simply have no ability to adapt and fix their own screw-ups. The harm committed here is just staggering, and makes a complete mockery of the so-called Hippocratic oath.

 

[Dolphin]

The BMJ has been good at posting e-letters over years. A lot harder to get into the print edition of course.

 

[Kitty]

I imagine the impact on NICE will be someone briefly rolling their eyeballs, so I plan to add the article to the gargantuan heap of crap I can't even remember happening.

 

[SNT Gatchaman]

If anyone has access to the full text, I'd like to see it please.

I'll DM it.

 

[Jonathan Edwards]

It's up there.

 

[Arnie Pye]

When I first started reading research articles and papers about ten years ago Cochrane was considered to be practically untouchable, always independent, and always right and nobody could disagree with what they said. Then this happened :

Source : https://en.wikipedia.org/wiki/Cochrane_(organisation)#History

During its 2018 annual meeting, the Cochrane board expelled Peter C. Gøtzsche, board member and director of Cochrane's Nordic center, from the organization, telling Nature that it had received "numerous complaints" about Gøtzsche after he co-authored an article in BMJ Evidence-Based Medicine alleging bias in Cochrane's May 2018[21] review of HPV vaccines. Gøtzsche's expulsion led four elected board members to resign in protest, which in turn led the board to cut two appointed members in order to comply with the ratio of elected to appointed members required by the organization's charter.[22] Gøtzsche announced that this had happened via an open letter, in which he said there is a "growing top-down authoritarian culture and an increasingly commercial business model" taking root at Cochrane that "threaten the scientific, moral and social objectives of the organization". Gøtzsche remains an outspoken critic of Cochrane's relationship with the pharmaceutical industry. The Cochrane board stated that Gøtzsche was expelled for his behavior, which had been reviewed by an independent counsel hired by Cochrane.[22]

If I remember correctly, Gøtzsche wanted Cochrane to be more independent of the private, commercial sector and his fellow board members (those who didn't resign or get fired, anyway) wanted to go the other way. It seemed me at the time that Cochrane had been undermined from within.

I wonder if some members of the BPS fraternity are hoping to do the same to NICE. I'm hoping that NICE is stronger than Cochrane is/was.

 

[Hutan]

The author is at the University of Sheffield which is where Christopher Burton and Vincent Deary are based who do awful stuff about MUS.

Jonathan A Michaels, honorary professor of clinical decision science

Just noting that Jonathan Michaels' title is not a proper 'professor'. The title of 'professor' is no guarantee of good sense of course, but at least an institution thinks it is or was worth paying the person to do what they do/did. That is, as far as I can see, not the case with an honorary professor. I assume a major qualification to be an honorary professor is that someone with the authority to make honorary professors likes what you say.

In the UK, this is the highest title to be awarded to individuals whom the university wish to appoint, honor, and to work with. These individuals are not university staff nor employees. An external person is usually recommended by an internal university academic staff, and recommended for approval by the head of department, for which the documents are then forwarded to faculty dean, vice president and president (or deputy vice chancellor) for approval.

 

[bobbler]

Just noting that Jonathan Michaels' title is not a proper 'professor'. The title of 'professor' is no guarantee of good sense of course, but at least an institution thinks it is or was worth paying the person to do what they do/did. That is, as far as I can see, not the case with an honorary professor. I assume a major qualification to be an honorary professor is that someone with the authority to make honorary professors likes what you say.

Is this the same gentleman? Jonathan A. Michaels (jmichaels.me)

 

[Hutan]

No, I don't think so. This seems to be the one:
https://www.sheffield.ac.uk/smph/jonathan-michaels

"I have had close links with the School of Health and Related Research in Sheffield since moving to Sheffield as a Consultant Vascular Surgeon in 1994. I was appointed to an Honorary Chair at the School of Health and Related Research in 2003 and to a Chair of Professor of Vascular Surgery in 2004. I stopped my clinical practice in 2011 but have continued with a number of research projects related to technology appraisal and decision science.

I recently completed an extensive research programme looking at The Design, Development, Commissioning and Evaluation of Patient Focused Vascular Services, funded by a six-year NIHR Programme Grant for Applied Research."
"My research interests include clinical decision science, economic and decision analytic modelling, technology appraisal, the organisation and delivery of sub-specialist services and the ethics of evidence-based healthcare policy. Due to my previous clinical experience many of these projects relate to areas of vascular disease, although I also have wider interests relating to a range of technologies and issues around outcome assessment, decision science and the ethics of policy decisions in healthcare."

 

[Hutan]

NICE’s rejection of graded exercise therapy for myalgic encephalomyelitis/chronic fatigue syndrome has been challenged by many specialists.5 These controversies may be the result of increasingly complex methods that fail to fully incorporate societal values and preferences.

It's possible that this is a reasonable man who just happened to pick a really really bad example that he didn't know much about to illustrate what appears to be a long running disagreement with NICE economic evaluations (he's published criticism of NICE before).

The thing is, the NICE ME/CFS conclusions actually did take into account many of the things Michaels seems to care about. In the case of ME/CFS, the benefits likely from any possible treatments were so small and uncertain that the economic evaluation analysis was probably a bit irrelevant.

However, other aspects of healthcare that are also important to patients, service users, and healthcare professionals are not currently quantified, including processes of care, and attributes such as fairness, dignity, accessibility, inclusivity, autonomy, and human interaction.

NICE got a whole lot of positive feedback that they made reasonable decisions with respect to fairness, dignity, inclusivity, autonomy and human interaction when it comes to the ME/CFS Guideline. We've got 64 consumer organisations lining up to suggest that the critics of the NICE ME/CFS guidelines, the supposed 'many specialists', are the ones who got things wrong.

The healthcare industry, with its technical expertise and extensive resources, may be more influential than societal interests in shaping NICE methods and determine many of the value judgments used in setting the research agenda, designing studies, interpreting findings, and selecting and submitting evidence to regulators.10NICE methods and decisions may also be influenced directly11 or indirectly12 by political priorities.

These are fair points, but actually the NICE ME/CFS Guideline process resisted these pressures (including incredibly overt texted pressures) to just look at the evidence.

Clinicians, patients, and the public must be able to trust that NICE guidance will not prevent healthcare professionals from recommending the best available treatment that aligns with patients’ circumstances and preferences. They must also trust that recommendations are not only evidence based but reflect overall societal values and preferences, rather than commercial or political interests. Ultimately, if NICE is to achieve its objective of providing value for money for the taxpayer its methods must transparently identify and incorporate all attributes of healthcare that are valued by society.

 

[Jonathan Edwards]

He seems to be a retired vascular surgeon with an interest in aneurysm repair using instrumentation rather than open surgery. I would not be surprised if a NICE committee had failed to endorse instrumentation because the surgeons on the committee didn't like the idea of losing business or something of that sort.

But his general thesis seems to meet be illogical. He is arguing for patient preference to be taken into account in NICE guidelines, rather than just evidence cost-effectiveness. As I see it this is not NICE's job. NICE's job is to evaluate cost-effectiveness and to recommend that treatments that are found to be cost-effective are offered to patients to choose from, as and so they wish.

If non-surgical aneurysm repair is preferred by patients, as one would expectant as was found in a telephone call study, that does not mean that it should be recommended if there is no reliable evidence of safety and effectiveness. If the treatment is just as good and not recommended because of stick in themed surgeons that is not the fault of NICE policy so much as the fault of vested interests by surgeons and a weakness on NICE's part to stick out for an evidence base.

 

[Sean]

NICE’s rejection of graded exercise therapy for myalgic encephalomyelitis/chronic fatigue syndrome has been challenged by many specialists.

The vast majority of whom are either ignorant of the real story (possibly wilfully so), or have a serious conflict of interest in protesting the NICE decision – specifically, they stand to lose from it.

NICE must also ensure that its recommendations don’t jeopardise the position of healthcare professionals as trusted advisers.

Difficult when those very healthcare providers are doing everything they can lose patient trust.

 

[FMMM1]

Thing is that even if NICE failed to properly assess an intervention, often it will be adopted elsewhere in the world. Supporters can then point to the evidence from that (other) jurisdiction to support its adoption in the UK [NICE].
We don't have anything to e.g. suggest that exercise, or CBT, are effective in ME/CFS, Lyme or long covid (i.e. long covid which matches ME/CFS). Anyone proposing interventions like that should go off and do the basic research to assess them i.e. using objective indicators as per the original PACE methodology. I'm not suggesting I'd support UK Government funding for PACE2!