This is the full story which is relevant to the NHS position in the uk.
M Lynch’s complaint about the CCGs Policy on: "(Management of) Hernias in Adults"
This policy is forcing me to consider either self funding costly private treatment again or waiting until my condition has deteriorated, to such a state that I will be suffering “significant functional impairment”, before my condition might be funded for surgical treatment by the NHS.
My principle complaints about this policy are:
- an EIA has not been undertaken;
- it is not supported by the evidence and sound justification;
- it is contrary to specific directions from the Department of Health;
- it is out of date and does not take account of the latest knowledge and guidance;
- it prevents GPs, in their role as patient advocates, in discharging their duty to take account of the needs of the individual and
- it is inequitable.
The details of my complaint, including my criticisms of this policy are set out below, which I should like the CCG to carefully consider in the forthcoming review.
Low Clinical Priority
The CCGs assertion that surgical repair of inguinal hernias is of low clinical priority is not substantiated by the evidence. Rather, it seems to have copied the approach by other CCGs (and former PTCs) and ceded to pressure from the Audit Commission (2011) that cited some hernia operations of low clinical value (and potentially cosmetic) that commissioners could stop funding, as a means of cost saving.
In my literature search on this matter, I have found no studies, evidence, data or analysis that supports the CCGs policy that surgical treatment of inguinal hernias is of low clinical priority or value. The Department of Health have repeatedly advised PTCs and CCGs that 'low clinical value' treatments must only be restricted on the basis of strict evidence-based criteria and that the arbitrary rationing of treatments on cost grounds alone is not permitted. In the case of IHR, even before this policy was introduced, there was substantial evidence of clinical benefit of surgical treatment, for the majority of patients. The notion that surgical treatment of even small inguinal hernias is “potentially cosmetic” is preposterous (especially from the perspective of my own experience) and is not supported by the evidence.
The latest analysis by King’s Fund and Imperial College, London (published in the Journal of the Royal Society of Medicine, May 2013) has indicated that the CCGs assertion that procedure is of “low clinical value” is unsound. The results of this analysis challenge the assertion that inguinal hernia surgery has low clinical value and that hernia surgery not only improves people’s lives substantially, as well as representing good value for NHS spending.
The categorisation of IHR as low clinical value appears to have been influenced by specious considerations of the risks that can arise from general anaesthetic and of post operative pain. It seems to me, that these risks have been significantly overstated to provide some qualitative weighting to help justify the low clinical value categorisation of IHR. In fact, many small inguinal hernias can be treated under local anaesthetic, which would largely eliminate the outcome risks of general anaesthetic from any quantitative cost benefit analysis. Also, estimates of the prevalence of chronic pain and discomfort following IHR vary widely between studies; so, the evaluation of chronic pain after IHR cannot be used a reliable quantitative metric in determining the value of the procedure. The literature shows that the cause of IHR pain is poorly understood, but the evidence shows that four factors can be predictors of chronic pain: a high level of pain preoperatively; age; an anterior surgical approach; and a postoperative complication. A high level of pain preoperatively of can only be exacerbated by the categorising IHR as low clinical value, because of the inevitable delay in treatment that this policy imposes on patients.
In addition to this, the Department of Health have said: "procedures are not unnecessary simply because patients do not have pain. They can be preventive or improve quality of life or mobility”. Furthermore, all hernias get progressively larger over time. A small hernia is easier to fix and the recovery is shorter compared to a large hernia. The benefits of IHR for the majority of patients are known, but seem to have been completely disregarded in the formulation of this policy.
The CCG has a statutory duty to demonstrate whether a procedure is genuinely of low clinical value, to justify any access restrictions on treatment. As far as I have been able to ascertain, in respect of this particular policy, the CCG (and former PTC) have not discharged this duty.
Referral Criteria & Evidence
The CCGs criteria for referral for IHR secondary care in this policy are extremely onerous and restrictive. Even though there is an exception funding process, it is so onerous that it effectively amounts to a blanket restriction. This does not accord with the Department of Health’s Operating Framework for the NHS, that “blanket restrictions on procedures or minimum waiting times that do not take account of healthcare needs of patients are not acceptable. Decisions on treatments, including suitability for surgery, should be made by clinicians based on what is best for the patient."
Additionally, the CCGs criteria for referral for symptomatic inguinal hernias for secondary care have been significantly tightened, without any justification, through the qualification that: “symptoms are such that they cause significant functional impairment”, before referral for secondary care or surgical treatment will be considered for funding.
This tightening of the policy criteria is unsound, because it not supported by the justifiable use of even the historic research and guidance that has been cited as evidence, in the following respects.
- The Fitzgibbons (2006) trial concluded that (watchful waiting) “delaying surgical repair until symptoms increase is safe and an acceptable option in minimally symptomatic inguinal hernias”. It did not endorse waiting until “symptoms are such that they cause significant functional impairment”, but that patients should be operated on once their symptoms (e.g. pain) increased.
- Flum (2006) only endorsed a watchful waiting as an appropriate strategy for the management of hernias that have no symptoms other than bulging.
- The Danish Hernia Database (2010) recommendations for the management of inguinal and femoral hernia in adults - contain guidelines which are based on the average patient and directs that they can be deviated from when necessary. Also, once diagnosed, hernia repair is recommended in the presence of symptoms affecting daily life, which is not as extreme as - “symptoms are such that they cause significant functional impairment”.
- The European Hernia society advocated a watchful waiting approach for those who are asymptomatic or minimally symptomatic. However, they recommend that those who are symptomatic should be considered for elective surgery. Again this does not justify the policy referral criteria that the CCG has stipulated.
- The conflicts in the studies looking at watchful waiting are acknowledge in the analysis of the evidence cited, which makes evidential extrapolation to the more onerous referral criteria in the policy incredible and even more unconvincing.
The most recent follow up studies and guidance do not support these tighter policy criteria at all.
The Fitzgibbons (2006) study has now been followed up (Long-term results of a randomized controlled trial of a non-operative strategy (watchful waiting) for men with minimally symptomatic inguinal hernias2013). This follow up indicates that the vast majority of men with asymptomatic or minimally symptomatic inguinal hernias will eventually come to surgery. This may not occur until years down the road, when their advanced age may render surgery more arduous. Fitzgibbons has said in presenting this work, "Although watchful waiting remains a safe strategy, even on long-term follow-up, patients who present to their physician to have their hernia evaluated, especially if elderly, should be informed that almost certainly they will come to surgery eventually. The logical assumption is that watchful waiting is not an effective strategy, as with time almost all men crossover”.
The results of this follow up study are virtually identical to those of the trial of watchful waiting, which was conducted by surgeons at the University of Glasgow. This study concluded that watchful waiting appears pointless, and they recommended surgical repair for medically fit patients, even for those with a painless inguinal hernia.
In addition the Groin Hernia Guidelines (promulgated September 2013 by the Association of Surgeons Great Britain and Ireland, the British Hernia Society and Royal college of Surgeons) advises that patients with symptomatic inguinal hernia should be referred to a secondary care provider for IHR.
Thus, the historic evidence that has been used to justify the criteria in this policy has been applied in an inconsistent and contradictory way. It certainly does not justify the extension of the referral criteria to “symptoms are such that they cause significant functional impairment”. The overarching advice of all the evidence cited in the policy and the most recent evidence and guidance is: patients with a symptomatic inguinal hernia, with no comorbidity and who are willing to undergo surgery, should be referred for IHR.
Equality Impact Assessment (EIA)
In the context of this particular policy, under the general equality duty (as set out in the Equality Act 2010), the CCG as a public authority is required to have due regard to the need to eliminate unlawful discrimination. As the CCG will no doubt be aware, the protected grounds covered by the equality duty are: age, disability, sex, gender reassignment, pregnancy and maternity, race, religion or belief, and sexual orientation. This duty has not been discharged in respect of this policy for the following reasons.
- No bespoke EIA pertaining to the inguinal hernia policy has been undertaken and published by the CCG (and former PTC), albeit it is Bristol CCGs intention to undertake EIA to inform the review of its Hernia Policy.
- The additional requirement that a symptomatic inguinal hernia must cause significant functional impairment, which is defined by the CCG as “symptoms preventing the patient fulfilling either vital work or educational responsibilities or vital domestic or carer activities”, is potentially (directly and indirectly) discriminatory in respect of gender and age. This is because, 98% of inguinal hernias occur in men (men being tenfold more susceptible to inguinal hernias than women) and while they can occur at any age; they are primarily a male and age-related condition. A significant number of older males with inguinal hernias will be excluded by this policy, because of their sex and age. This huge gender imbalance and self evident disproportionate impact on men should be properly considered in an EIA.
- The EIA also needs to take account of the further qualification to the referral requirements that: “symptoms prevent the patient fulfilling vital work, educational responsibilities, carrying out vital domestic or carer activities”. These have been explicitly listed as a factor that influences eligibility for IHR. This significantly disadvantages older patients (male and female) of non-working age, who may have comparable symptoms and who may gain quality-of-life from the procedure. I also challenge whether the CCG is empowered to lawfully apply these further social-demographic qualifying criteria, given the fiscal contribution and ethical issues that this raises. Also, the application of employment or educational status may at least be impractical, as these can change for any individual; so, it is difficult to see how the CCG can legitimately take account of these and make funding of treatment decisions that are fair to all patients.
Overall, in examining this matter, I have the distinct impression that the CCGs current policy is solely aimed at cost savings ahead of the individual needs of patients. As a public body the CCG has a statutory duty to undertake an EIA and explain the reasons for its commissioning decisions, in a clear, cogent and transparent manner. This duty has not been fulfilled by the CCG for this policy, because it is procedurally flawed and based on selective, irrational and fallacious use of the relevant evidence.