Conflicting asthma guidelines cause confusion in primary careBMJ 2018; 360 doi: https://doi.org/10.1136/bmj.k29 (Published 09 January 2018) Cite this as: BMJ 2018;360:k29
All rapid responses
BMJ Rapid Response re: Keeley and Baxter: Conflicting asthma guidelines cause confusion in primary care
Matthew Hoghton1, Victoria Tzortiou Brown2, Imran Rafi3
1 and 3 RCGP Clinical Innovation and Research
2. Honorary Secretary RCGP
We welcome the Primary Care Respiratory Society (PCRS) editorial 1 and its broader perspective on asthma diagnosis and management in the light of relevant guidance from National Institute for Health and Care Excellence (NICE) 2 and British Thoracic Society/ Scottish Intercollegiate Guideline Network (BTS/SIGN) 3.
The Royal College of General Practitioners (RCGP) has supported the work of NICE since its inception in 1999. The Clinical Knowledge summaries (CKS) are based on the NICE guidelines have been used by generations of GPs at the point of care to help inform best clinical practice.
However, we share the concerns raised in the editorial by Kelley and Baxter on behalf of the PCRS about recommending an asthma diagnostic test (FeNo) that is not easily available within primary care .
The editorial also highlights the importance of reserving patient secondary care referrals for those patients who are identified as high risk (e.g. from the Review of Asthma deaths 4. Most asthma diagnosis is done in primary care, reducing demand on secondary services and referrals made to secondary care when there is diagnostic uncertainty.
The British Thoracic Society (BTS) 6 have identified the key differences between the BTS/SIGN and NICE guidelines on the diagnosis and management of asthma. These include diagnosis, pharmacological management, the introduction of leukotriene receptor antagonists (LTRA) after low dose inhaled corticosteroids (ICS), maintenance and reliever therapy (MART) and treatment beyond combined inhaler therapy as well as some other issues in managing asthma in children. The BTS/SIGN guidelines also provide recommendations on inhaler devices, the management of acute asthma attacks in both adults and children, the management of difficult to control asthma and the management of asthma in adolescents, in pregnant women and due to occupational factors.
The methodology used by NICE in the production of single unified guidelines on a clinical area helps to reduce the potential of over-representation of any organisation, specialist group or pharmaceutical company and aims to provide clarity for health care professionals, patients and their families. NICE generally does not reproduce a guideline where another body has created an NICE-accredited guideline with the exception of the BTS/Sign Asthma guidelines 5. Keeley and Baxter call for a unified guidance that covers diagnosis and management as well as economic analysis combining the strengths of both organisations. We agree that such an approach can reduce the confusion that might have inadvertently arisen across the UK. It is encouraging that NICE seems to stand ready to take the next steps in developing such a joint approach.
1. Keely D and Baxter N, 2018. www.bmj.com/content/360/bmj.k29
2. National Institute for Health and Care Excellence (NICE) Asthma diagnosis, monitoring and chronic asthma management, 2017. https://www.nice.org.uk/guidance/ng80
3. British Thoracic Society/ Scottish Intercollegiate Guideline Network. British Guidelines on the management of asthma. 2016. http://www.sign.ac.uk/assets/sign153.pdf
4. Royal College of Physicians. Why asthma still kills: the National Review of Asthma Deaths (NRAD) Confidential
Enquiry report. London: RCP, 2014.
5. www.nice.org.uk/About/What-we-do/Accreditation/Accreditation-decisions (accessed 13.1.2018)
6. White J, Paton JY, Niven R, et al Guidelines for the diagnosis and management of asthma: a look at the key differences between BTS/SIGN and NICE Thorax Published Online First: 03 January 2018. doi: 10.1136/thoraxjnl-2017-211189
Competing interests: No competing interests
We are grateful to all respondents for their comments. We thank Drs Levy, Ryan, Gaduzo, Thomson and Leung for their generally supportive observations. Dermot Ryan is entirely sceptical about the role of NICE, but we feel that judgements about the relative cost effectiveness of diagnostic approaches and therapeutic interventions are important if we are to provide the best possible care with limited resources.
It is very encouraging that that for NICE, Drs. Menzies Gow and Alexander – and Professor Mark Baker in his remarks quoted in the accompanying news piece – are in favour of a single collaborative and comprehensive UK guideline. We hope that negotiations to achieve this will proceed swiftly.
Menzies Gow and Alexander state that, with regard to the diagnosis recommendations , “objective testing is shown to be cost effective through NICE’s primary care pilot study and in robust economic models developed by our committee” but we would question this. We note the health economic modelling in Appendix M of the guideline that was carried out before the implementation study using inputs from published evidence, but we wonder whether a further analysis using inputs from the implementation study findings would still support use of the NICE algorithm.
A report from the implementation study appears as an appendix to the NICE guideline This study included 143 patients with suspected asthma and 35 patients eventually diagnosed with asthma in the seven participating practices. These highly motivated practices were provided with FeNO testing at no cost, and financial support for spirometry training for staff (which practices had difficulty in accessing). In this study –
• 59% of patients with suspected asthma remained of uncertain diagnostic status at the end of the study period (25% had asthma).
• Spirometry was normal in 73 % of those diagnosed with asthma.
• Diagnostic value of FeNO in the study is not reported.
• Fourteen ( 10% ) of the patients with suspected asthma reached the point in the algorithm of requiring bronchial provocation testing – which was in effect not available – no patient had undergone this test by the time the project closed.
The report states that six of the seven practices would continue to use the diagnostic algorithm if the guideline were issued. We attended the meeting in December 2016 at which the pilot practices reported back and came away with an impression of greater doubt over this, particularly if practices were required to fund FeNO testing and spirometry training themselves. In our view, the experience in the pilot bore out our concerns.
Importantly, NICE’s economic analysis made the unrealistic assumption that all FeNO testing and spirometry would be performed in primary care, and allowed no costs for increased referrals from primary care for asthma diagnosis. This strikes us as a major omission.
Professor Baker states that “ neither guideline is wrong”, but in respect of the recommendations for diagnosis we disagree. We think the NICE diagnostic algorithm is flawed. Spirometry is normal in most primary care patients with asthma, the role of FeNO remains controversial among experts, and bronchial provocation testing is effectively unavailable. We fully support wider use of objective testing, but think that peak flow monitoring should be the first line objective test in primary care. We remain of the view expressed in our initial submission to the NICE consultation that it would have been better not to publish this part of the guideline.
We agree with Professor Littlejohn that money is better spent supporting implementation than duplicating guidelines. But the implementation costs for the controversial NICE diagnostic algorithm would be high and there is no indication that such funding is available. We wonder why the Department of Health referred to NICE the topic of asthma which was already well covered by the highly respected and NICE approved BTS/SIGN guideline. The single national guideline that we need should indeed be co-badged, but we think it would be better for NICE to support the continuation of the comprehensive and familiar BTS/SIGN guideline.
Dr Duncan Keeley
Dr Noel Baxter
Primary Care Respiratory Society UK
Competing interests: No competing interests
In their editorial on the differences between the NICE and BTS/SIGN Asthma Guidelines, Keely and Baxter (1) are right in saying that the UK needs a single, regularly updated, comprehensive and evidence based guideline. But I am not convinced that their “logical way forward” is the best solution.
During my period as Clinical and Public Health Director at NICE (1999-2012), having designed the methods and processes that the Institute used to develop its guidelines according to the AGREE criteria (2), I spent much of my time managing the “fall out” when NICE recommendations differed from other professional guidance, both within the UK and internationally. We invariably managed to find solutions but they were usually tailor made to individual issues. However one generic solution was to encourage the Department of Health not to refer subjects that were already well covered. Asthma was a case in point and in the early days NICE produced guidance on COPD. Obviously something happened in 2013 to change this policy. Another successful approach was to co-badge guidance.
The editorial seems to suggest that NICE should become the “health economic” engine for the continuation of a BTS/SIGN guideline. Why not have a jointly badged UK guideline, all equal partners. Guideline development and updating is an expensive and protracted business. Better to spend the money on supporting their implementation than duplicating production.
1. Conflicting asthma guidance causes confusion. Keely D, Baxter N.BMJ 20th January 2018 page 94.
2. Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project. The AGREE Collaboration Qual Saf Health Care. 2003 Feb;12(1):18-23.
Competing interests: No competing interests
Thank You for expressing so well the frustration felt by so many of us respiratory interested clinicians. As a GP and GPSI I find myself astounded that we could end up with 2 guidelines which contradict rather than compliment each other. Agreed, guidelines are not tramlines, and as GPs we have at least one set for a whole host of clinical conditions. This is precisely why we need clarity and not the muddle NICE have created. The place for suggesting a radical change in the way services are organised in the diagnosis of asthma is not in a guideline document like this. It is surely the duty of NICE to work with other organisations such as BTS, SIGN, PCRS-UK, Asthma UK, BLF etc, to improve the clarity of message given by guidelines which clinicians rely on to light the way forward, not muddy the waters.
Competing interests: No competing interests
As co-chairs of the NICE guideline committee on asthma, we support the general consensus that a guideline with contributions from NICE and BTS/SIGN covering all aspects of management and care is a desirable aim. It is encouraging that NICE stands ready to take the next steps in developing a single, joint approach.
With regards to our recommendations on diagnosis and monitoring, we appreciate that there are challenges carrying out spirometry and FeNO testing in primary care and in children. However, as objective testing is shown to be cost effective through NICE’s primary care pilot study and in robust economic models developed by our committee, we feel that this can be achieved through the right support and resources.
We acknowledge that it will take time before it can be established as routine practice. NICE’s advice is to use current approaches to diagnosis from the BTS/SIGN guidance until capacity is in place.
Competing interests: Dr Andrew Menzies-Gow and Dr John Alexander were co-chairs of the NICE guideline on asthma: diagnosis, monitoring and chronic asthma management. Dr Andrew Menzies-Gow has attended advisory boards for GlaxoSmithKline, Novartis, AstraZeneca, Boehringer Ingelheim and Teva. He has received speaker fees from Novartis, AstraZeneca, Vectura, Boehringer Ingelheim and Teva. He has participated in research with Hoffman La Roche, GlaxoSmithKline, Boehringer Ingelheim and Astra Zeneca He has attended international conferences with Astra Zeneca and Boehringer Ingelheim and has consultancy agreements with AstraZeneca and Vectura.
It would of course be desirable to see one single guideline for the management of asthma in the United Kingdom, but the two organisations, SIGN/BTS and NICE have two separate and differing underlying philosophies which make this highly unlikely. On the one hand we have the SIGN/BTS guidelines, internationally recognised and respected, who strive for clinical excellence, and on the other hand we have NICE, whose motives are cost minimisation to the extent that it proposes a therapeutic pathway which at best is sub-optimal and at worst could cause actual harm. Both parties agree on the need to make an accurate diagnosis of asthma and to record the grounds on which this diagnosis was made. They disagree fundamentally on the way of achieving this. NICE has not taken into account the potential costs and opportunity costs of their proposed diagnostic work up nor the cost of educating and upskillng health care professionals in new techniques (FeNO) let alone the cost of the equipment and consumables which will be needed. It is important to recognise that their recommendations for diagnosis lack a clear evidence base.
The purpose of guidelines is in essence to act as a repository of best available knowledge: the purpose of evidence based medicine was to use this evidence adapted to the needs of the individual patient using the skill and experience of the clinician to optimise outcomes. (1) It is unfortunate that guidelines have become abused by politicians and health care managers alike to force clinicians into slavish adherence. In turn such adherence blunts the skill of clinical reasoning, an essential component of good clinical practice.
The profession is thus somewhat at a crossroads: Is the purpose of medicine to help people in an evidence based fashion or does it abrogate responsibility for high quality clinical care by accepting without question that NICE has all the answers? There is a great need to have this debate as a matter of urgency.
(1) Sackett, D.L., 1997, February. Evidence-based medicine. In Seminars in perinatology (Vol. 21, No. 1, pp. 3-5). WB Saunders.
Competing interests: I was twice a member of the BTS/SIGN Asthma Guideline. I was a previous chairman of the General Practitioners in Asthma Group ( now PCRS UK). I have been sponsored to attend meetings, attend advisory panels and deliver talks on behalf of most companies in the respiratory field. I am the current President of the Respiratory Effectiveness Group http://effectivenessevaluation.org/
I understand clinicians' concern of having two national guidelines which give conflicting recommendations.<1> However, is this incident a wake-up call that today clinicians are too dependent on guidelines?
"The NICE guidelines said..." This is probably the trump card used whenever clinicians want to defend their judgement. But when you inquire about the rationale and evidence behind the guidelines, some clinicians can suddenly become speechless. They do not always try to learn the reasons behind the recommendations. Some recommendations can simply be opinion-based, because no better evidence is available.
Even if randomised-controlled trials and systematic reviews are available, the guidelines extrapolate these data to apply to the general population. Clinicians must understand that the clinical context of each patient is unique, and can make certain guidelines inapplicable. This makes clinicians irreplaceable, because they can apply clinical evidence, along with their patients' history, examination and investigation findings, to determine the management plans and which guidelines to follow.
Perhaps, it is time for clinicians to put their critical thinking caps on, rather than solely regurgitating guidelines. Or else, the NHS could replace clinicians with printers which reproduce guidelines, and have laymen to blindly follow the guidelines. That would be a bad cost-saving strategy that hinders patient care.<2>
After all, many clinicians learned evidence-based medicine and critical analysis during their training. There are reasons why these topics are in their school curriculum.
1. Keeley D, Baxter N. Conflicting asthma guidelines cause confusion in primary care. BMJ. 2018;360:k29.
2. Rimmer A. Spend more on NHS or see services deteriorate further, hospital leaders warn. BMJ. 2018;360:k175.
Competing interests: No competing interests
Keeley and Baxter (1) make a strong case for a single UK asthma guideline and for NICE to contribute its expertise in cost-benefit analysis to the widely used and respected BTS/SIGN guideline.(2)
The recent NICE guideline (3) has produced confusion rather than clarity particularly on asthma diagnosis in children. Most children with asthma are managed well in primary care. The NICE diagnostic algorithm for children over the age of 5years puts spirometry as the first diagnostic test and fails to acknowledge that the time and expertise required to achieve reproducible results in young children is unlikely to be available in most general practices. The Primary Care Respiratory Society consensus advice (4) on how to deal with the conflicting guidance is therefore most welcome.
Guidelines are time consuming and expensive to produce.
Many respiratory professionals have devoted hours of their own time as contributors to these guidelines wishing only to improve asthma care.
The statement by Mark Baxter from NICE (5) that he accepts the need for a single guideline is welcome and all respiratory professionals must hope that the “stumbling blocks” of different “methodologies” are addressed immediately so that there is no repetition of dual guidelines for asthma or any other condition.
1. Conflicting asthma guidelines cause confusion in primary care BMJ 2018;360:k29
2. British Thoracic Society/Scottish Intercollegiate Guideline Network. British guideline on the management of asthma. 2016.
3. National Institute for Health and Care Excellence. Asthma: diagnosis, monitoring and chronic asthma management. 2017.
4. Primary Care Respiratory Society UK. Asthma guidelines briefing document. 2017.
5. “Conflicting” UK asthma guidelines should be streamlined, experts say BMJ 2018;360:k99
Competing interests: No competing interests
I welcome this editorial from the PCRS-UK, and agree with most of their points, particularly that the UK should have a single cohesive guideline for asthma care. The UK has the highest childhood death rates for asthma in Europe (1) and third highest in high income countries worldwide, (2) Furthermore the UK Government commissioned, national review of asthma deaths (NRAD) (3) demonstrated that over 60% of asthma deaths are associated with major preventable factors known for over 50 years, coupled with failure to implement the UK guidelines. Sadly, 18 of the 19 NRAD recommendations have not been implemented nationally nearly three years after publication, despite at least two subsequent high profile inquests resulting in Regulation 28 statements based on the coroners' conclusions these were preventable asthma deaths. (4, 5) In fact, the previously published National Institute for Health and Care Excellence (NICE) Quality Statement 25 (6) had not been implemented in my view, in either of these two cases; so rather than commissioning new guidelines, no doubt at considerable monetary expense and professional time, perhaps a national directive to implement existing guidelines and NRAD should have been placed!
While diagnostic hubs are a good idea, even the cash strapped NHS its unlikely that we will see these implemented in our lifetimes. It is hard to understand why NICE (7) have strongly recommended their diagnostic algorhythm despite such dismal results of their own feasibility study; which in my view should have been subjected to the same level of scientific rigour applied to the other evidence; with a logical conclusion to abandon it rather than herald its implementation - albeit phased. In particular : less than 30% of those eventually diagnosed with asthma had any evidence of airflow obstruction; 59% had an ‘uncertain diagnosis’; and it took an average of 57 minutes (range 30–100, SD 18) of scarcely available repeated consultation time in general practice to apply the algorhythm. (8)
On treatment, NICE quite correctly defines asthma as an inflammatory condition and yet, recommends, in my view, illogically and in contrast with the British Thoracic Society (BTS)/Scottish Intercollegiate Guideline Network (SIGN) guideline,(9) that short acting bronchodilator (SABA) reliever inhalers should be prescribed for newly diagnosed people with asthma. Furthermore, it is astounding that in contrast with BTS/SIGN, Global Initiative for Asthma (GINA) evidence based strategy document, (10) and systematic review evidence (11) most other international asthma guidelines in existence, NICE has recommended the addition of Leucotriene receptor antagonists (LTRAs) rather than long acting beta-agonists (LABAs) to treatment for people with poorly controlled asthma.
Hopefully, common sense will prevail and the powers that be will see fit to agree one clear, practical guideline for the UK; in my view, the evidence based, GINA Strategy, (10) which is written by experts, specifically for generalists, which is updated every six months, and free from political or industry influence, would be a good start – but then some may say I’m biased – being part of the GINA group as well as the Acute Asthma BTS/SIGN Guideline group!
1. Wolfe I, Thompson M, Gill P, Tamburlini G, Blair M, van den Bruel A, et al. Health services for children in western Europe. The Lancet. 2013;381(9873):1224-34.
2. Global Asthma Network. The Global Asthma Report 2014.2014. Available from: http://www.globalasthmareport.org/resources/Global_Asthma_Report_2014.pdf.
3. Why asthma still kills: the National Review of Asthma Deaths (NRAD) Confidential Enquiry report: Royal College of Physicians. London; 2014 [Available from: http://www.rcplondon.ac.uk/sites/default/files/why-asthma-still-kills-fu....
4. Terrence Carney. Regulation 28 statement in the matter of Tamara Mills (Deceased). 2015 [Available from: https://www.judiciary.gov.uk/wp-content/uploads/2016/01/Mills-2015-0416.pdf.
5. Dr Shirley Radcliffe. Regulation 28 Statement in the matter of Michael Uriely (deceased) 2017 [Available from: https://www.judiciary.gov.uk/wp-content/uploads/2017/03/Uriely-2017-0069....
6. Asthma. NICE quality standard 25 (2013): National Institute for Health and Clinical Excellence; 2013 [updated 3/6/2013. Available from: http://publications.nice.org.uk/quality-standard-for-asthma-qs25.
7. NICE Asthma Guideline - Full Evidence 2017 [Available from: https://www.nice.org.uk/Guidance/NG80/Evidence
8. Commissioned by the National Institute for Health and Care Excellence (NICE). Asthma: diagnosis and monitoring of asthma in adults, children and young people. NICE guideline NG80 Appendices A - R 2017 [Available from: https://www.nice.org.uk/guidance/ng80/evidence/appendices-a-r-pdf-465617...
9. British Thoracic Society, Scottish Intercollegiate Guideline Network. SIGN 153 - The British Guideline on the Management of Asthma. 2016 [Available from: https://www.brit-thoracic.org.uk/document-library/clinical-information/a...
10. The Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA).2017. Available from: http://www.ginasthma.org/.
11. Chauhan BF, Ducharme FM. Addition to inhaled corticosteroids of long-acting beta2-agonists versus anti-leukotrienes for chronic asthma: John Wiley & Sons, Ltd; 2014 [Available from: http://dx.doi.org/10.1002/14651858.CD003137.pub5
Competing interests: I have no competing interest with regard to my letter which is written in the interest of people with asthma in the UK, who I believe are getting a raw deal through a lack of a national cohesive forward plan for managing asthma, preventing attacks and preventing preventable deaths. In the last two years I have accepted fees for Consultancy from Teva UK Limited, Novartis, Clement Clarke International, and Boehringer Ingelheim. For the sake of clarity: I have accepted lecture fees from - Teva UK Limited, AZ, GSK, Chiesi Pharmaceuticals, NAPP Pharmaceuticals mainly for lectures on the NRAD and lessons from asthma deaths. I have served on Drug Safety Monitoring Board for multinational studies by Chiesi Pharmaceuticals. I serve on the GINA Executive (no personal funding - however, travel and accommodation for meetings has been paid for)