A NICE guide
A ruling lays bare the problem of inconsistent NICE guidelines and the illogicality they can create, as Jock Mackenzie explains
In the birth injury case, Sanderson v Guy’s and St Thomas’ NHS Foundation Trust  EWHC 20 (QB), the High Court considered the approach to be taken to the impact of National Institute for Health and Care Excellence (NICE) guidelines.
The facts are straightforward. The claim concerned a 25-minute period leading to the claimant’s (C) delivery in 2002 and focused on the actions of the consultant obstetrician (B). The judgment sets out the relevant timeline effectively agreed between the parties.
There were two primary issues on breach of duty for the court to consider. The first concerned B’s decision to perform an FBS following her assessment between 00.40 and 00.48/49 hours.
C argued the cardiotocography (CTG) trace showed a prolonged deceleration between 00.38 and 00.43 continuing over three contractions, which was a sign of acute fetal compromise, the only reasonable management being immediate instrumental delivery which should have taken place in room 4 if no other facilities were available.
C also asserted B’s concern that room 4 was not sufficiently safe because instrumental delivery would be nigh on impossible, based on her finding on vaginal examination of a fixed head, was misplaced.
There were a couple of less relevant subsidiary allegations: B should not have left room 4; and having left, being away for four minutes was too long.
Both parties relied upon obstetric experts. C’s expert’s assertion that urgent delivery was the only reasonable management following 00.43 relied on his interpretation of the 2001 NICE guidelines on the use of electronic fetal monitoring. There were three required links in his chain of argument:
- The guidelines’ definition supported the fetal heart complex between 00.38 and 00.43 as being a single prolonged deceleration;
- The guidelines’ statement that a prolonged deceleration greater than three minutes was “clear evidence of acute fetal compromise”; and
- The further statement that where there was clear evidence of compromise, FBS should not be performed but the baby delivered urgently.
The question for the court was whether C’s obstetrician’s interpretation of the guidelines was correct. The answer was a fairly emphatic: ‘No’. The judge noted that C’s expert consideration that the guidelines were, in essence, the be all and end all, and any failure to follow them to the letter, would not be reasonable. The defendant’s (D) expert disagreed and considered that the guidelines were limited – not a substitute for clinical judgement but an adjunct to it.
The judge observed that the problem with reliance on the guidelines here was that they were internally inconsistent. On their face, they appeared “to advocate two contradictory management options in response to a single prolonged deceleration lasting longer than three minutes: conservative measures where possible or feasible (expressly including fetal blood sampling) and a few short paragraphs later urgent delivery (fetal blood sampling being contraindicated). On the critical question for my determination, the guidelines point in two, entirely different, management directions”.
She was critical of C’s expert’s formulaic analysis of the guidelines out of context. Further, once the guidelines’ authority had been undermined, the expert had no fallback position. For example, he made no observations on the significance of fetal heart recovery between 00.38 and 00.43 and during the vaginal examination, which D’s expert considered to be reassuring and positive features.
Two additional points, which she described as curious, relating to C’s expert’s evidence were noted by the judge. First, he gave evidence (in an “unguarded” moment) that “in a general sense… we would wait… if there is a return to the baseline with normal variability and that goes on, then there is no need for immediate delivery”. This was close to D’s expert’s position and was inconsistent with C’s expert’s interpretation of the guidelines.
Second, C’s expert observed that FBS would have been an appropriate response to a single prolonged deceleration in the first stage of labour with vaginal delivery not being possible. However, this statement was inconsistent with his evidence that a single prolonged deceleration, as evidence of acute fetal compromise, mandated urgent delivery; accordingly, it was also illogical.
The judge rejected C’s expert’s interpretation of the guidelines, which was “highly selective” and ignored the internal inconsistency. She acknowledged the guidelines were useful but concluded they were to be used in conjunction with clinical judgement. In this case, they were only workable if the obstetrician also exercised judgement in assessing “the appropriate response by reference to the trace as a whole”, namely including the points C’s expert had failed to comment upon (eg regarding fetal heart recovery), to which he had no response save to “note that these sorts of qualifications do not feature within the guidelines”.
She concluded that a reasonable interpretation of the trace was a stressed fetus suffering from chronic hypoxia rather than an acute event. Without hindsight, a reasonable obstetrician would not worry the trace presaged an acute event and, although the trace mandated action, reasonable action included performing an FBS.
On D’s invitation, the judge was also critical of C’s expert as being inflexible. He did not consider urgent instrumental delivery in an ill-prepared room was dangerous, even though he conceded there were risks of intra-uterine death or brain damage because, if the procedure failed, a caesarean section would not have been possible. The judge found C’s expert’s refusal to accept this point surprising.
She rejected C’s two subsidiary allegations in short order, effectively concluding B was the best placed person to seek and obtain the FBS equipment. There was no reason to disbelieve her evidence that she did things as fast as she could.
The second main issue concerned B’s management following her return at 00.53 with the FBS equipment, and once she noted a bradycardia, which C asserted started at 00.47. C argued urgent delivery was mandatory and the six-minute interval to 00.59 to start delivery was too long. However, this was also swiftly dismissed.
The judge accepted B’s evidence and considered that she had moved as fast as she could. C’s criticisms of B had failed to take into sufficient account the “real world” of a busy and short-staffed maternity unit, which explained the period of time that B took. B had also not taken any unnecessary steps.
As for hypothetical factual causation, although not strictly necessary the judge set out her conclusions by reference to the timings in each of three hypothetical scenarios. Her conclusion was that at best, C would have been delivered between five and seven minutes earlier than was in fact the case.
Context The most important aspect of this case relates to the first main allegation. The judge reached the conclusion that the relevant NICE guidelines were not to be slavishly followed and were only an adjunct to clinical judgement.
However, that conclusion needs to be contextualised. The judge was faced with internally inconsistent guidelines and an expert who had not identified, and was unable to address, that inconsistency and the illogicality it created. This was compounded by the expert’s oral evidence which substantively undermined his position as well as his credibility.
The expert’s opinion needed to be able to withstand logical analysis. That his position relied on a strict interpretation of internally inconsistent guidelines was always likely to be problematic unless he could rationalise that inconsistency.
On my reading of the case, the conclusion was not so much about the status of guidelines as the quality of expert evidence, given the expert’s narrow interpretation of flawed guidelines; his inconsistent and illogical position; and his dogmatic persistence in that position – traits that will rarely find judicial favour.
The guidelines in this case were not prescriptive to be followed slavishly. However, whether material departure from guidelines in a different case would be reasonable will no doubt remain dependent upon specific facts and expert evidence.
Dr Jock Mackenzie is a partner at Anthony Gold anthonygold.co.uk