National Institute for Clinical Excellence (NICE) guidance ignored: NHS England rationing plan is not Nice at all

NHS England proposals to withdraw 17 NHS clinical procedures contradict existing guidance from NICE, the recognised authority advising clinicians on the current state of research evidence.

“Clinicians should read NICE guidance for themselves rather than take NHS England’s word for it,” says KONP co-chair and retired Consultant Dr Tony O’Sullivan. “We ask clinicians and the public to reject unjustified rationing plans which will force patients to suffer or seek private treatment, the thin end of the wedge for further cuts to come.”

In a public consultation which closes on 28 September, NHSE asks for views on proposals to withdraw clinical procedures including hysterectomy for heavy menstrual bleeding, and removal of benign skin lesions unless complex criteria are met. The 103-page Consultation document gives the impression that the proposals are fully in line with NICE, whose logo appears on the cover, and that NICE was a source for the proposals.

However:

For nine procedures, NHSE does not cite any evidence from NICE.
For five, the NICE evidence cited does not support the NHSE proposal
For one, the NICE evidence cited gives only partial support.
Only for two procedures does the cited NICE evidence back the NHSE proposal.

Some NICE guidance, not cited by NHSE, contradicts proposals and/or refers to relevant ongoing research. And in one case (intervention for snoring surgery [ref 3A]), NHSE is bypassing unfinished NICE guidance research with a cited publication date of August 2020.

The proposals appear to derive from a 2009 report by McKinsey Corporation on how the NHS could respond to the banking crisis.

“Existing NICE and other clinical guidelines are already cautious, conservative, thorough and periodically under clinical review. Clinical practice should change in response to proven research following systematic review, not pre-empt it. NHSE is bypassing unfinished research cited in NICE guidance. Clinicians should take decisions in discussion with patients without bureaucratic referral-blocking processes when guidance exists and is in practice already,” Dr O’Sullivan concludes.

[ends]

Notes

1. The full NHS England Consultation document is here:
https://www.engage.england.nhs.uk/consultation/evidence-based-interventions/user_uploads/evidence-based-interventions-consultation-document-1.pdf

2. Many of the NHSE proposals appear in a set of slides prepared for the Dept of Health by McKinsey Corporation in 2009:
http://webarchive.nationalarchives.gov.uk/20130211154023/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_116521.pdf
Achieving World Class Productivity in the NHS 2009/10 – 2013/14:
Detailing the Size of the Opportunity
March 2009
[see slides 51-52]

3. The disparities, and occasional concurrence, of NHS England proposals and NICE evidence are as follows.

A) snoring surgery: NHSE propose this procedure [surgery] should no longer be routinely commissioned. No support from NICE is cited by NHSE.
However, NICE is currently preparing guidance on Sleep disordered breathing https://www.nice.org.uk/guidance/indevelopment/gid-ng10098 with Expected publication date: August 2020. Status: in development.

B) Dilatation and curettage (D&C) for heavy menstrual bleeding in women: NHSE propose D&C should not be used for diagnosis or treatment for heavy menstrual bleeding. Cited NICE guidance https://www.nice.org.uk/guidance/ng88/chapter/Recommendations concurs re treatment, but re diagnosis says “Do not use dilatation and curettage alone [emphasis added] as a diagnostic tool for HMB”. This means D&C can be used in conjunction with other diagnostic tools.

C) Knee arthroscopy for patients with osteoarthritis: NHSE propose Arthroscopic knee washout should not be used as a treatment for osteoarthritis, and cite NICE: https://www.nice.org.uk/guidance/ipg230/chapter/1-Guidance
The NICE guidance, by contrast, says 1.1 Evidence on the safety and efficacy of arthroscopic knee washout with debridement for the treatment of osteoarthritis is adequate to support the use of this procedure provided that normal arrangements are in place for consent, audit and clinical governance. 1.2 Current evidence suggests that arthroscopic knee washout alone [emphasis added] should not be used as a treatment for osteoarthritis.

D) Injections for nonspecific low back pain without sciatica: The NHSE proposal concurs with cited NICE guidance https://www.nice.org.uk/guidance/ng59 1.3.1 Do not offer spinal injections for managing low back pain.

E) Breast reduction: NHSE proposes criteria, all of which must be met, before NHS will provide breast reduction for women. No psychosocial criteria are mentioned. No NICE guidance is cited. However, NICE identifies Commissioning guidance from the Royal College of Surgeons (2014) https://www.evidence.nhs.uk/document?id=1610391 with rather different criteria, including “Have some or all of the following signs and symptoms:
Emotionally and socially bothered by having large breasts
Low self-esteem and depression
Breast size limits physical activity
Back, neck and shoulder pain caused by the weight of breasts
…”

F) Removal of benign skin lesions: NHSE proposes a complex set of clinical diagnoses and criteria without which benign skin lesions will not be removed by the NHS. Suspected malignancies are not covered by the proposal, and should be treated or referred according to NICE skin cancer guidelines, NHSE states. The cited NICE guidelines https://www.nice.org.uk/guidance/csg8 and https://www.nice.org.uk/guidance/ng12 both concern dealing with suspected cancer, and do not refer to the exclusions proposed by NHSE for removal of benign skin lesions. The full guidance csg8 includes a pathway (p81) with a box “Benign, AK or in situ SCC – treat” – i.e. treat Benign skin lesions.

G) Grommets for Glue Ear in Children: The cited NICE guidance https://www.nice.org.uk/guidance/CG60/chapter/1-Guidance#surgical-interventions
concurs with the NHSE proposal that the NHS only commissions this surgery for the treatment of glue ear in children when the criteria set out by the NICE guidelines are met

H) Tonsillectomy for Recurrent Tonsillitis: NHSE propose a set of criteria for surgery for treatment of recurrent severe episodes of sore throat. No NICE guidance is cited. Also, as NHSE acknowledge, a national randomised control trial is under way comparing surgery versus conservative management for recurrent tonsillitis in adults. The NHSE proposal is being put out to consultation before the trial is completed.

I) Haemorrhoid surgery: NHSE proposes that surgical treatment should only be considered for those that do not respond to specified non – operative measures or if the haemorrhoids are more severe, specifically: * Recurrent grade 3 or grade 4 combined internal/external haemorrhoids with persistent pain or bleeding; or * Irreducible and large external haemorrhoids.
No NICE guidance is cited. However, the NICE clinical knowledge summary https://cks.nice.org.uk/haemorrhoids recommends referral to secondary care for further investigation and management for “People who do not respond to conservative treatment”, and “People with recurrent symptoms who do not respond to primary care management”. Surgery is listed as a secondary care option.

J) Hysterectomy for heavy menstrual bleeding: NHSE proposes that hysterectomy should not be used as a first – line treatment solely for heavy menstrual bleeding. It is important that healthcare professionals understand what matters most to each woman and support her personal priorities and choices. Hysterectomy should be considered only when: other treatment options have failed, are contradicted; there is a wish for amenorrhoea (no periods); the woman (who has been fully informed) requests it; the woman no longer wishes to retain her uterus and fertility.
The cited NICE guidance https://www.nice.org.uk/guidance/ng88/chapter/Recommendations#management-of-hmb
includes
1.5.10 For women with fibroids of 3 cm or more in diameter, take into account the size, location and number of fibroids, and the severity of the symptoms and consider the following treatments: pharmacological: non-hormonal: tranexamic acid NSAIDs[2] hormonal: [This bullet point has been removed. See information on EMA review and safety measures] LNG-IUS[1] combined hormonal contraception[3] cyclical oral progestogens uterine artery embolisation surgical: myomectomy hysterectomy. [2018] [emphasis added]
NICE is not saying hysterectomy is only an option if all others have failed or are contradicted. NICE is detailing situations in which hysterectomy is one option, along with others. Despite this, NHSE claims their proposal is “based on NICE guidelines”.

K) Chalazia removal: NHSE proposes criteria for the incision and curettage of chalazia. No NICE guidance is cited. However, a uncited NICE clinical knowledge summary https://cks.nice.org.uk/meibomian-cyst-chalazion is consistent with the proposal.

L) Arthroscopic shoulder decompression for subacromial shoulder pain: No NICE guidance is cited.

M) Carpal tunnel syndrome release: No NICE guidance is cited.

N) Dupuytren’s contracture release: NHSE proposes criteria for surgical treatment of Dupuytren’s contracture. It cites NICE guidance https://www.nice.org.uk/guidance/ipg43
which concerns needle fasciotomy as a viable procedure, alternative to surgery.
The NICE guidance cited does not evaluate surgery, but their evidence says surgery is usually indicated for individuals who have a significant functional disability. A NICE information leaflet quotes an expert in favour of the long term impact of open surgery.

O) Ganglion excision: NHSE proposes criteria for ganglion excision. No NICE guidance is cited.

P) Trigger finger release: NHSE proposes that surgery should be only performed in specific cases where alternative measures have not been successful. No NICE guidance is cited.

Q) Varicose vein surgery: NHSE proposes that NHS treatment is excluded for patients whose veins are purely cosmetic, and excludes compression hosiery to treat varicose veins unless interventional treatment is unsuitable. It cites NICE guidance https://www.nice.org.uk/guidance/qs67/chapter/quality-statement-3-treatment-of-varicose-veins#quality-statement-3-treatment-of-varicose-veins
The full NICE guideline https://www.nice.org.uk/guidance/cg168/evidence/varicose-veins-in-the-legs-full-guideline-pdf-191485261 includes the following re cosmetic impact:
Whilst the GDG [Guidance Development Group] were keen to not be seen to make a recommendation about cosmetic surgery on the NHS, they were apprehensive about making a judgement on the impact of cosmetic concerns on the individual. They felt that the impact that symptomatic varicose veins has on the quality of a patient’s life should be explored individually when deciding the best course of action.
NICE also states “If offering compression bandaging or hosiery for use after interventional treatment, do not use for more than 7 days.”