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Litigation related to regional anaesthesia: careful reading and interpretation needed.

Last post 23 Jun 2010, 1:10 PM by Tim Cook. 0 replies.
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  •  23 Jun 2010, 1:10 PM 544

    Litigation related to regional anaesthesia: careful reading and interpretation needed.

    Iwould like to respond to Bedforth and Hardman’s editorial comment [1] on ourpaper [2] on behalf of all authors. Unfortunately the editorial hasmisinterpreted the data and as a result draws conclusions that are notsupported by those data. However, I write not to criticise the authors but toensure that the interpretation of the data we presented is corrected. The analysis we performed was based on an extensive and careful examination of a large dataset of NHS Litigation Authority (NHSLA) claims filed under anaesthesia. I will not repeat the method which is described elsewhere [3]. I would like to raise three points. 

    First, the financial analysis in the database is based on the overall cost to the NHS of the claims. We stressed this very carefully in our methods section stating: ‘The cost associated with a closed claim as described in the NHSLA database is the cost of defending a claim, including legal fees (both claimant and defence) and the cost of any settlement, but excluding the cost of the NHSLA itself. The dataset did not contain the information required to determine the proportions of claims successfully defended, or settled in or out of court. Neither were the proportions of claim cost allocated to legal fees and patient settlement available.’ This caution over data interpretation is also explicitly stated in the discussion. These are explicit explanations of the term ‘cost’. Examination of claims and cost related to different clinical areas enables an exploration of the overall financial burden of claims related to certain types of complication or sub-specialty area. However, this is the limit of financial interpretations: we do not know which claims were settled, which led to award of damages, nor the extent of any such damages. It is therefore concerning that Bedforth and Hardman repeatedly refer to the cost as ‘damages’ and ‘awards’: our data contain no breakdown of this information. Of note in 2007, 51% of NHSLA cost was lawyers’ fees and 49% payment of awards to claimants: for individual cases these proportions will likely range from 100% to close to 0%. Therefore, it would be wrong to presume that cost is related to award.

    This incorrect reading of the meaning of ‘cost’ mean that several of the conclusions drawn in the editorial are unsupported by the data, and the arguments they build on these conclusions, are weakened. Within, the editorial authors state that ‘we know….. the number of complications that led to successful claims’. This is not so. The dataset we examined is not restricted to successful claims but also includes claims which were successfully defended in court, those that never reached court and those which remain open. The editorial authors appear to build an argument based on this mistake that neuraxial anaesthesia and epidurals might be less safe than other areas of regional anaesthesia practice. In doing this, they appear to ignore the fact that nerve injury accounted for fewer than one third of claims and in the obstetric dataset failure to provide effective analgesia/anaesthesia was the most frequent cause of litigation. They argue that the high number and cost of such claims may be explained in a number of ways, but fail completely to consider that these claims may be costly to defend, whether successfully or not. Determining the relative ‘safety’ of different regional blocks is not the point of this letter, but to emphasise that our data offer no evidence one way or the other about risk: it is primarily about litigation and its cost.

    Secondly, the authors mistakenly infer that the highest cost claim (£2 070 000) was an obstetric case. Table 7 shows that this case was non-obstetric. Of note, this was not an ‘award’ of £2 000 000 but a claim that cost the NHSLA £2 000 000: we neither know whether the claimant was successful, nor the value of any award if there was one. Their conclusions about the relative damages awarded (and by implication severity of injury) for obstetric and non-obstetric claims are not supported by the data. Our comment in the paper that the cost (financial burden) of obstetric claims is generally higher than for non-obstetric claims is accurate.

    Thirdly and separately, Bedforth and Hardman’s interpretation of the 3rd National Audit Project (NAP3) of the Royal College of Anaesthetists [4] requires a brief response. The authors use data from NAP3 to support their argument that ‘epidural anaesthesia may not be as safe as we once thought’. NAP3 examined not just neurological complications but ‘all cause’ permanent harm following neuraxial block and found rates of permanent harm that were considerably lower than most previous studies on this topic (for both spinal and epidural techniques [4-6]), notably when compared to several recent high profile reports based on much smaller cohorts at single hospitals [7-8]. As part of the balanced approach to this topic, readers may usefully consider Wijeysundera’s large study published in the Lancet, which showed an 11% relative risk reduction in mortality in patients receiving epidurals for major elective surgery [9]. The authors did not study emergency surgery, but if such a risk reduction also applies in emergency surgery the mortality benefits would be of considerable consequence [10].

    To summarise, our paper provides no data on the benefits, demerits, safety or risk of regional anaesthesia. Such an argument will continue separately, and requires a balanced analysis of sadly incomplete evidence. We believe there are several important clinical lessons to learn from our analysis, and we refer interested readers to our discussion. Our paper clearlys shows that regional anaesthesia, and in particular obstetric regional anaesthesia, account for a large percentage of legal claims against NHS anaesthetists. Analysis of this subset of claims suggests that the injuring event leading to the claim is generally of lower severity than other claims in the wider dataset. It also shows that the overall cost associated with these claims is lower than other types of claim. We conclude that regional anaesthesia and particularly obstetric regional anaesthesia are relatively litigious areas of NHS anaesthetic practice in the UK.

     

    TM Cook

    Royal United Bath Hospital

    Bath, UK

    E-mail: timcook007@googlemail.com

     

     

    Conflict of interest

    I am an author of the Report on the 3rd National Audit Project of the Royal College of Anaesthetists.

     

    References

    1        The hidden cost of neuraxial anaesthesia? Bedforth NM, Hardman JG. Anaesthesia; 2010; 65: 437-9.

    2        Szypula K, Ashpole KJ, Bogod D, et al. Litigation related to regional anaesthesia: an analysis of claims against the NHS in England 1995–2007. Anaesthesia; 2010: 65: 443–52.

    3        Cook TM, Bland L, Mihai R, Scott S. Litigation related to anaesthesia: an analysis of claims against the NHS in England 1995-2007. Anaesthesia 2009; 64: 706-18.

    4        Cook TM, Counsell D, Wildsmith JAW. On behalf of the Royal College of Anaesthetists Third National Audit Project. Major complications of central neuraxial block: report on the 3rd National Audit Project of the Royal College of Anaesthetists. British Journal of Anaesthesia 2009: 102: 179-90.

    5        Cook TM, Counsell D, Wildsmith JAW. Is the outcome for central neuraxial blockade really reassuring? British Journal of Anaesthesia 2009: 102;  714-6.

    6        Cook TM, Counsell D, Wildsmith JAW. Major complications of central neuraxial block: the Third National Audit Project (NAP3); some comments and a few questions. British Journal of Anaesthesia 2009: 103: 131-2.

    7        Christie I, McCabe S. Major complications of epidural analgesia after surgery: results of a six-year survey. Anaesthesia  2007; 62: 335-41.

    8        Cameron CM, Scott DA, McDonald WM, Davies MJ. A review of neuraxial epidural morbidity: experience of more than 8,000 cases at a single teaching hospital. Anesthesiology 2007; 106: 997–1002.

    9        Wijeysundera DN, Beattie WS, Austin PC, Hux JE, Laupacis A. Epidural anaesthesia and survival after intermediate-to-high risk non-cardiac surgery: a population-based cohort study. Lancet 2008; 372: 562-9.

    10    Cook TM, Counsell D, Wildsmith A. Who might benefit from, or be harmed, by epidural anaesthesia? Anaesthesia, 2009; 64: 216-7.

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