Exclusive NICE is to open up its planned guidelines on asthma diagnosis for a second consultation, after GPs piloting the newly recommended algorithm found the tests involved were expensive, time consuming and did not necessarily improve the accuracy of diagnosis, Pulse has learned.
It comes over two years after the health watchdog initially unveiled the plans to get GPs to diagnose the condition more rigorously, in particular through routine use of exhaled FeNO levels tests and spirometry.
The plans met with so much uproar from GP experts that NICE chiefs backed down and agreed to set up pilots to test the feasibility of the new approach, results of which were due to be published alongside the final guidelines this summer.
However, Pulse understands GP experts have questioned whether the new tests should be implemented on the basis of results unveiled at a stakeholder meeting last December.
NICE has now revealed it will carry out another consultation on the proposals, at which point a full report on the pilot results will be made available to stakeholders.
NICE originally set out the plans to radically overhaul the way GPs diagnose asthma back in January 2015, following research that suggested up to a third of patients are being misdiagnosed with the condition.
The new approach would see GPs obliged to carry out objective tests including spirometry and FeNO measures to confirm any diagnosis.
But the plans met with huge resistance from the profession GP profession, with the GPC warning that they would lead to a big increase in costs and workloads for practices and mean GPs would have to refer many more patients to secondary care for the extra tests.
NICE subsequently took the unprecedented step of pausing the publication of the guidelines, so that it could carry out trials of the approach in GP practices. The trials ran between May and October last year at GP practices, which were each given £3,000 to collect data for evaluation as well as money for new FeNO kits as well as any necessary training and extra nurse time.
The results were discussed at a closed meeting with stakeholders in December and GP experts at that meeting told Pulse anonymously that the results presented indicate that the use of FeNO testing was prohibitively expensive for individual practices, and spirometry often did not add useful information to the diagnostic process.
And in official comments now seen by Pulse, the Primary Care Respiratory Society has advised NICE: ‘Our perception of the outcome of the pilot studies in primary care commissioned by NICE is that our concerns were borne out in practice, with FeNO found to be expensive and spirometry was time consuming and largely non-contributory to asthma diagnosis in the primary care setting.’
Professor Mark Baker, director of the centre for guidelines at NICE, said: ‘In response to comments submitted during this consultation period, we commissioned an implementation feasibility project which looked at how our new recommendations can be introduced effectively and efficiently.
‘We recognise that our new recommendations could represent a step change to current clinical practice, and this is why we have decided that our guideline on asthma diagnosis and monitoring will go out for public consultation again after the next committee meeting in May.’
How NICE whipped up a storm over asthma diagnosis
BTS/SIGN guidelines on asthma have up to been widely recognised as the ‘gold standard’ guidelines for GPs to follow.
However, NICE last year set out plans to introduce its own guidelines on diagnosis and monitoring of the condition, claiming that evidence had shown up to a third of patients with asthma may have been misdiagnosed, and advising that GPs would in future have to carry out spirometry and bronchodilator reversibility tests, and in some cases FeNO breath tests, in order to confirm a diagnosis in anyone over the age of five.
However, the plans were heavily criticised by GP leaders who questioned the basis for using certain tests and warned they would force GPs to refer large numbers to specialist clinics. NICE has then took the unprecedented step of putting the guidelines on hold, until the recommendations have been piloted at practices around the country to test out the ‘feasibility of the diagnostic algorithm – in particular the routine use of FeNO and spirometry.
The BTS/SIGN guidelines have since been updated and in contrast to NICE, continued to advise GPs to use a trial of therapy to inform diagnosis, at least in people with a high probability of asthma, provided they monitor and record the response in terms of peak flow and symptoms.