Revalidation is process which all health regulators are required to put in place to assure the public that doctors are up-to-date and complying with medical professional standards. Every five years throughout your professional life they will be this reassessment.

In the paper produced by the Department of Health in November 2008 they indicated that regulators must present a robust business plan demonstrating the benefits which will accrue from revalidation and the GCC have decided the best person to do this is David Byfield and the Welsh Institute of Chiropractic in Glamorgan. The DOH produced guidelines for revalidation.

*“ Principle 10 (Demonstrating Benefits – effective in confirming fitness to practise) The structures and processes surrounding revalidation should knit together in a coherent, unbureaucratic and proportionate manner to ensure that resources invested yield valid and reliable outcomes together with the anticipated benefits to service users and health professionals”.[1]*

In January 2010 the GCC produced a draft document to present to the profession. The paper had been put together with the help of economics consultants) and was supposed to present a robust business case demonstrating the benefits which would come to chiropractic patients by introducing revalidation.The table below indicates the “estimated” savings made by British patients of chiropractors. This chart gives an indication of the mind set of the visionaries planning the future of chiropractic in the UK. I guess to make the case for regulation chiropractic must be dangerous however I have no idea As the way that these figures were developed.

By the second meeting in March, I am told the 10 year cost for radiation induced Cancer by chiropractors was reduced from £8,436,000 down to £340 over a ten-year period. “Unnecessary chronicity” apparently an invention of the GCC based on spurious “facts” , was reduced from £95,222,000 to 0 over a ten-year period!

How on earth could the regulator have tried to present such wildly inaccurate calculations in support of revalidation? The answer maybe that elements within the GCC will use revalidation as a tool to medicalise chiropractic.

In putting revalidation out for tender this is how the GCC expressed its requirement *“GCC decided at a very early stage of its thinking that it needed to develop a quality assured infrastructure for delivery of the revalidation scheme, to stand in place of the managed environment of the NHS and independent/voluntary sectors in which significant numbers of other regulated health professionals practise”.*

The four UK professional associations supported the bid of the College Of Chiropractors for the revalidation contract, the GCC panel consisting of Grahame Pope (a Physiotherapist), Ian Dingwall ( a chiropractor) Paul Ghuman (Margaret Coats Gofor)and Margaret Coats, gave the contract to David Byfield as they did with the Test of Competency.

Below is the method and logic the GCC are using to justify revalidation. If revalidation goes through it will be onerous expensive and ultimately unworkable. It will be the ordinary chiropractors in practice who will bear the brunt of this and the expense.

Without the intervention of the SCA and UCA the original figures would have passed almost without notice. However Chiropractors have to face up to the fact their registration fees are going to fund this crap and they may not wish to be led to the GCCs medical utopia.

**Forecast number of patients that might be affected and the number of events**

Question 11 of the survey we sent to chiropractors asked registrants to state what proportion of their patients could have had a better outcome if their care had been managed and/or implemented differently. It was emphasised that zero was an acceptable response.

Based on responses to this question, we have calculated through use of a weighted average that 4.15 per cent of patients experienced a sub-optimal outcome in 2009. The most common reason for the sub-optimal outcome was stated to be patient non-compliance (61.0 per cent of sub-optimal outcomes, on average) followed by inadequate care management (13.2 per cent of sub-optimal outcomes, on average).

*Sensitivity analysis — number of events*

The central estimate of loss due to sub-optimality is based on the survey responses that, on average, 4.15 per cent of patients experience a sub-optimal outcome. Of course, we do not assume that the statistic calculated from survey responses is completely accurate — all surveys with a response rate below 100 per cent are subject to some potential inaccuracy, and there is always a possibility that some individual replies may not be entirely correct. Therefore, in addition to calculating QALYs lost based on an estimate of 4.15 per cent of patients experiencing sub-optimal outcomes we will also utilise upper-bound and lower-bound estimates. As discussed with the Expert Group, the central estimate of the proportion of patients experiencing sub-optimal outcomes will be adjusted upwards and downwards by 10 per cent to give an upper bound of 4.565 per cent and a lower bound of 3.735 per cent.

**Total loss of QALYs attributable to preventable failings**

To quantify the impact of a sub-optimal outcome, we first use the results of the UK BEAM trial to estimate the pre-treatment EQ-5D score of chiropractic patients.

To estimate the loss suffered by these patients as a result of the sub-optimal outcome it is necessary to know the gain that could have been made had their care been optimal. For the purposes of quantification we assume that patients experiencing a sub-optimal outcome still derive some benefit of their chiropractic care, but that this benefit is lower than it would otherwise have been. In particular, we assume that patients experience a QALY gain equal to that which would be achieved through best care in general practice, but that they do not obtain the ‘added value’ experienced by most patients that receive chiropractic care. Hence, we assume the QALYs lost through the sub-optimal outcome is equal to the difference between QALYs gained by the group which received best care in general practice in the UK BEAM trial and the group that received a package of care which included spinal manipulation and exercise.

It is also necessary to have an estimate of the typical amount of time over which a patient would experience a sub-optimal outcome. We fully acknowledge that some sub-optimal outcomes could be experienced for short periods (for example if a patient receiving symptomatic care visits their chiropractor the following week and the chiropractor resolves the issue) whilst others could be experienced for far longer (for example if the sub-optimality is ‘hidden’ to both chiropractor and patient). However, the Revalidation Working Group agreed that, for the purposes of this work, it would be reasonable to assume that the sub-optimality is typically experienced by the patient for a period of one month (i.e. 0.083 of a year).

*Sensitivity analysis — duration of sub-optimality*

The central estimate of loss due to sub-optimality is based on an assumption, agreed with the Revalidation Working Group, that sub-optimal outcomes would typically persist for one month. Of course, in some cases the sub-optimality would be resolved more quickly that this, whereas in other cases the sub-optimality may take longer to be resolved and, in the extreme, may never be resolved. As a result of the uncertainty in our central assumption, we wish to consider what the potential losses would be under different assumptions. On the advice of the Working Group, we therefore also calculate the loss on the assumptions that the sub-optimality would persist for two weeks (i.e. 0.038 of a year) and alternatively that the sub-optimality might persist for six weeks (i.e. 0.115 of a year).

Given the estimate derived above that 4.15 per cent of patients might experience a sub-optimal outcome, in 2009 the central estimate of QALYs lost as a result of this event is:

*QALYs lost = Number of patients (1,005,000)*

**Percentage of patients with a sub-optimal outcome (4.15%)*

**Missed improvement in QALYs through sub-optimality (0.051)*

**Duration of sub-optimality in years (0.083)*

*= 177 (rounded to nearest QALY)*

*Sensitivity analysis — number of events*

Using the lower bound estimate of the proportion of patients that experience a sub-optimal outcome, the number of QALYs lost is 159. Using the upper bound, the figure is 194 QALYs lost.

*Sensitivity analysis — duration of sub-optimality*

Using the lower estimate of the duration of sub-optimality discussed above, the number of QALYs lost is 81. Using the higher figure, the figure is 245 QALYs lost.

**Monetary value of QALY loss**

NICE does not have a threshold or a cut off point above which no treatment will be approved and has been clear that this is not the case. Each treatment is considered on a case-by-case basis. Generally, however, if a treatment costs more than £20,000-30,000 per QALY, then it would not be considered cost effective. Consequently, *the following estimates of the monetised value of adverse events and sub-optimal outcomes in chiropractic are based on a value of £30,000 per QALY. *

Quantification of this risk assumes that, as an upper bound, 4.565 per cent of patients experience a sub-optimal outcome each year. As a lower bound, we assume that 3.735 per cent of patients are affected in this way. It is assumed that the number of patients will increase by approximately 38,800 per annum over the next 10 years and hence the number of sub-optimal outcomes increases by between 1,455 and 1,804 per annum.

Based on these assumptions, the central estimate of the annual monetised QALY cost of sub-optimal outcomes rises from £5.46m in 2010 to £7.12m in 2019. The present value of the cost of this risk over 10 years, calculated with a real discount rate of 3.5 per cent, is approximately £51.86m.

*Sensitivity analysis — number of events*

As an upper bound, the present value of the cost of this risk over 10 years is approximately £58.21m whilst the lower bound estimate is approximately £47.63m.

*Sensitivity analysis — duration of sub-optimality*

As an upper bound, the present value of the cost of this risk over 10 years is approximately £71.86m whilst the lower bound estimate is approximately £23.74m.

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