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The COPD guidelines “To be NICE, or to wear GOLD" ..... this is the question?


Introduction

COPD guidelines have been in use by clinicians in primary and secondary care in the UK since the publication of the first BTS guidelines in 1997.1 These guidelines were subsequently updated in 2004 through the collaboration between the BTS and NICE to produce the first combined COPD guidance.2 However, and around the same time in 1997, GOLD was launched as collaboration between the National Heart, Lung and Blood Institute (NHLBI) in the USA and the World Health Organisation (WHO) with more of a global direction.3

Since 1997, the two guidelines have differed slightly; their differences have started to become more obvious in recent times, which has created some confusion. 
As a general rule, in the UK it is commonplace for physicians to adopt UK guidance (i.e. NICE), and this is probably the case throughout the country; however, GOLD guidance carries some significant, and quite useful, differences in the messages it gives. 
Whilst the NICE 2019 guideline is more brief and focused; GOLD 2020 document is quite detailed and offers a comprehensive reference for COPD in general.
I hope that this article will help you understand both guidelines, identifying the main differences and similarities.

Diagnosis of COPD

NICE

GOLD

Little has changed here compared to previous guidelines.
Assessment of symptoms (breathlessness, cough, sputum production, wheeze) is considered important.4
Objective assessment of severity of breathlessness using MRC scale.4,5

Spirometry is considered a cornerstone for the diagnosis and monitoring of the condition. This has to be post bronchodilator test (not to be confused with reversibility testing) and has to be quality assured. NICE recommended using the Global Lung Initiative (GLI) reference values (ECCS reference values are commonly used currently in the UK) although GLI does not cover all ethnic groups.4,6
NICE suggests that in younger patients with Obstructive Spirometry, an alternative diagnosis should be considered before the diagnosis of COPD is confirmed.

Here, and as a new feature, NICE inserted a special section on COPD as incidental finding on Chest x-ray (CXR) or Computed Tomography (CT) thorax.4
In this case clinical review is a must. Smokers should be advised of the risks of continuing to smoke and be supported to stop. Non-smokers can be assured that risk of progress is low. Both smokers and non-smokers should be made aware of the risk of lung cancer in this case.4

After talking about the definition, and the burden of COPD; GOLD goes into good details about the morbidity of the condition addressing the economic and social burden of the condition worldwide. It is also useful to find a section on the impact of exposure to polluting particles, early lung development events (ie. relationship between birthweight and FEV1in adulthood), childhood infections and socioeconomic status on disease development.

Similar to NICE, there is an emphasis here on symptoms and a good history. Symptoms are discussed here in some detail and more than the NICE guidance.

GOLD suggests assessment of ongoing exposure to risk factors at the same time as making the diagnosis (tobacco exposure, pollution etc).9

Spirometry is also considered here to be essential to confirming the presence of airflow limitation. Guidance here includes some very useful tips on spirometry, and how to perform a post bronchodilator test making the point that reversibility testing is no longer recommended.9
The use if GLI reference values with lower limit of normality (LLN) is also discussed here, but GOLD appreciates the complexity this may add to the diagnosis; and as such, GOLD recommends the use of fixed ratio over LLN with GLI equations.9

For:
Really well thought and detailed, including the section on incidental diagnosis on CXR or CT (particularly with the ongoing lung cancer screening projects across the UK).

For:
Spirometry tips are very useful. Also, the section on risk factors and exposures is very good.

Against:
Are we ready to move to GLI values yet?

Against:
If you don’t like a lot of reading, then this is not for you!


Assessment of the disease

NICE

GOLD

The main change here is that NICE has moved away from recommending the BODE index for assessment of prognosis as the tool is unable to reliably classify people in high or low risk groups, it is not better than FEV1 alone and it is time consuming as includes variable not routinely available in primary care.4

The general clinical assessment including assessment of BMI, FEV1, comorbidities Etc remains the same as previous version and as GOLD. COPD Assessment Test (CAT) is recommended for assessment of symptoms.4,7

FEV1 is considered the main measure to assess the severity of airflow limitation (but not the overall disease). Airflow limitation is divided into 4 groups in those who have obstructive spirometry (FEV1/FVC<0.7). These are mild; moderate; severe; and very severe. These grades are similar to ATS/ERS, and to the current GOLD classification.4,8,9

NICE also highlights the importance of opportunistic case findings through performing spirometry in smokers/ ex. Smokers who suffer from chronic cough.
There is also criteria for referral to specialist services, which remains the same as per previous guidelines.4

BODE combined assessment tool continues to be recommended by GOLD.9

The general clinical assessment of symptoms (using CAT), risks, and severity of airflow limitation (Using FEV1) is generally the same as per NICE recommendations.

There is an emphasis on comorbidities here and on evaluating these.9

One of the main differences here is using the ABCD tool to guide the initial treatment in patients based on multi-dimensional assessment tool using combination of symptom severity (MRC or CAT), and exacerbation frequency. FEV1 is not included in this tool here; although GOLD acknowledges that this tool is similar to FEV1 alone in predicting mortality!9

Like NICE, GOLD highlights the importance of various tests like CXR, lung function, blood gases, and assessment of exercise tolerance on evaluating COPD.9

For:
BODE was always scarcely used in primary care. Perhaps not a bad idea to remove it!
Having criteria for referral to a specialist is really helpful.

For:
Using the ABCD tool to start treatment appears to better address the multi-dimensional aspect of the condition rather than FEV1 only.
It is also useful to have a section on biomarkers and role of Eosinophils.

Article:
We could have done with a bit more information on the usability of biomarkers.

Article:
There is no clear advice on how clinicians should use Eos. count in clinical practice (how many measurements, over what duration, and when these are taken).

Non-Pharmacotherapy

NICE

GOLD

The previous recommendations have not changed much here regarding value of smoking cessation support and therapy, pulmonary rehabilitation, pneumococcal and flu vaccination, MDT approach to management, education that is tailored to patient’s needs and self-management.

On the issue of self-management, NICE updated its guidance and recommends that this should be individualised and reviewed regularly.4 Rescue packs can be offered to those who are confident and able to understand how to use them correctly if they have a history of >1 exacerbation in the last 12 months.4 However, the use of rescue packs should be subject to regular review.

Very similar to NICE, with updated citation on new evidence since last guideline publication.

There is also more information on the impact of reducing exposure to air pollution, reducing occupational exposure in certain professions, on controlling COPD.9

Self-management was described by GOLD as important but with the caveat that there is no evidence it will change behaviour on its own. However, self-management with the support of a case-manager and a written management plan is recommended to reduce hospitalisation.9

Self-management should educate and motivate focusing on symptom control, through PR and energy conservation; as well as managing exacerbations with the use of action plan and avoiding aggravating factors.9

Endurance training as part of pulmonary rehabilitation is described in some detail here using number of different techniques to reach 60- 80% of symptom limited work-out. Inspiratory muscle training was also reviewed, and GOLD pointed out that this did not translate to better exercise performance, reduction in breathlessness, or improvements in quality of life (QoL).9

GOLD recommended number of questionnaires to measure symptoms and Qol like CAT, CRQ, SGRQ, HADS, or PRIME-MD.9

For:
Not much change here and all these recommendations are well supported by evidence.

For:
Generally similar to NICE but some more details provided.

Against:
Not much; although the challenge here has always been uptake and implementation.

Against
The flow of this section could have been improved for ease of reading.

Pharmacotherapy - Inhaler Therapy

NICE

GOLD

The same previous principles apply here.
For example:
- Short acting beta-2 agonists (SABA) is the recommended initial empirical therapy.
- Do not use oral corticosteroid reversibility tests to predict response to inhaled corticosteroids (ICS).
- Do not rely on lung function alone to evaluate response to therapy.

FEV1 has now been removed as a measurement for determining if inhaler therapy should be used.

The main update here is to offer LABA+LAMA combination therapy as the first line step up from SABA in those without asthmatic features.4
ICS+LABA can be offered instead of LABA+LAMA in those with asthmatic features.4

If a patient is already stable on a single bronchodilator, then they should remain on it.4

For those who remain symptomatic, or experience 2 moderate exacerbations, or 1 severe exacerbation (leading to admission), they can be stepped up to triple LAMA+LABA+ICS.4

Trials of therapy should be evaluated after 3 months of treatment, and choice of product should take into account device and inhaler technique, patient’s preference, potential side effects, and cost.4

The advice regarding the use of spacers and nebulisers has not changed from previously.

GOLD defines the purpose of treatment is to reduce symptoms and minimise risks (mainly exacerbations).9

The main difference to NICE is that GOLD suggests that SABA use alone should not be the usual practice. Instead patients should be offered either long acting beta agonists (LABA) or long-acting muscarinic antagonist (LAMA) alone or in combination as first line therapy.9

Choosing the right treatment in the right device is considered essential, and the same principles as per NICE’s recommendations here apply.

Follow figure 4.2 in the GOLD guidance to check the initial treatment options in patients based on the A, B, C, and D staging, with FEV1 having no impact on determining treatment choice.9 Not surprisingly, blood eosinophil count is used here to guide the initiation of ICS in patients within group D.9

It is important to distinguish that the recommendations above are the initial treatment choice rather than representing a step-up approach. For example, Treatment recommended in group C is not a step up from group B, instead it is the treatment of choice who present with COPD having not had treatment before. This initial assessment shows they are in group C.

Moreover, GOLD recommends a review/ assesses/ adjust cycle, and treatment can be modified based on another algorithm – figure 4.4 in the guidance.
Blood eosinophils feature heavily here to guide treatment choice in relation to ICS initiation.9

Finally, and quite interestingly, GOLD suggests considering PDE4 inhibitors (Roflumilast), a Macrolide, or even stopping ICS (with caution) in those with low Eosinophils count!9

For:
Much simpler and pragmatic compared to previous guidance.

Removal of the confusing FEV1% in determining treatment choice.

For:
Really good to target treatment towards the dominant features of the disease (symptoms vs. exacerbations). The use of Eosinophils here is quite good. There is also some flexibility in those who are symptomatic but not to the degree of initiating LAMA+LABA in combination. These can be started on LAMA, then stepped up to LAMA+LABA should symptoms worsen.

Against:
Although it sounds simple, distinguishing those with asthmatic from those without asthmatic symptoms is not that straight forward. Perhaps, eosinophils may need to feature here!

Some clinicians may view the recommendation of initiating LAMA+LABA straight away to be excessive and not required for all patients.

Against:
To be honest the guidance here is quite comprehensive and not much can be criticised, although it can be argued here that it can overwhelming to primary care.

Pharmacotherapy - Other Considerations

NICE

GOLD

Most of the recommendations here remain the same as 2004 and 2010 guidelines, including those on the use of nebulisers and spacers. The advice on cleaning of spacers is quite useful.4

The use of oral corticosteroids (OCS) is generally not recommended and if used, dose should be minimised.4

Oral Theophylline should only be considered after bronchodilatation therapy is optimised. Prescribers have to be aware of side effects, interactions, and dose monitoring; and response should always be evaluated.4

The advice on using mucolytics has not changed.

The most significant update here is on the use of prophylactic antibiotics, mainly oral Azithromycin. These can be used at a dose of 250 thrice weekly in patients who do not smoke and are optimised on inhaler therapy. Azithromycin is recommended in sputum producers who suffer prolonged exacerbations leading to hospitalisations. If Azithromycin is prescribed then frequent sputum surveillance for C&S, sputum clearing techniques and doing a CT to check for bronchiectasis should be considered.4

Baseline ECG and liver function tests should also be performed and monitored; with frequent review of side effects (hearing loss) at 3 and then 6 monthly intervals.4

The use of Roflumilast is also considered here and this was subject to a NICE Health Technology Appraisal.10 Roflumilast can only be initiated by a specialist.

As for long term Oxygen therapy (LTOT), this remains largely the same. In those with resting PaO2 on air 7.3- 8 kPa, LTOT can be considered if they have Cor-pulmonale, secondary polycythaemia, or oedema.

Risk assessment is essential, including assessing for risk of fire, in the case of smokers within the household.4

NICE has recommended that current smokers who do not engage in smoking cessation should not be prescribed LTOT!4

The guidelines also emphasized the important facts that Short burst and ambulatory Oxygen should not prescribed for treating breathlessness only. However, ambulatory Oxygen should be considered for those with exercise driven de-saturation.4

There was no major change in the recommendation for long term Non-invasive ventilation (NIV), which should be delivered in specialist centres.4

No major differences with NICE in relation to using oral corticosteroids (OCS).

Also, GOLD did not exert a lot of enthusiasm towards the use of Theophylline and highlighted the concern around the side effects and the interactions profile.
This is also the case regarding Mucolytics driven by modest clinical effect.9

The recommendation regarding the use of Azithromycin is also similar, although not as detailed in terms of when to start and what to monitor as NICE.

Roflumilast is viewed similarly by GOLD, and the value is mostly realised in exacerbators, although the side effect profile is seen as a significant concern.9

Recommendations regarding LTOT initiation is generally the same. GOLD did not touch on the issue of current smokers in terms of prescribing Oxygen.
However, they have recommended that monitoring those who are started on long term oxygen therapy (LTOT) can be done via monitoring O2Sat to keep it greater than or equal to 90%. LTOT initiation should be reviewed in 60- 90 days, with figure 4.5 of the GOLD 2020 guidance providing a very useful flow chart summarising the process.9

The use of non-invasive ventilation (NIV) in the management of very severe disease is similar to NICE’s recommendations. These patients would normally have pronounced hypercapnia; and using NIV becomes more important in these patients if they have comorbidities like obstructive sleep apnea (OSA). However, GOLD suggests that the evidence here is not very clear, and this issue has to be handled by specialists.9

For:
Really easy to follow.

For:
Detailed, and well structured.

Against
Not much can be found to criticise here.

Against
Some of the sections could have included more details, in particular when it comes to having a specific criteria to follow when to starting Roflumilast or Azithromycin

Other Considerations

NICE

GOLD

There is more information compared to previous guidelines although the majority of the recommendations remain the same on:4
- Fitness for surgery
- Telemonitoring (not routinely recommended)
- Travel advice
- Diving
- OT and social assessment of patients
- Palliative care input
- Value of nutritional support
- Comorbidity (including management of anxiety and depression)
- Identification and management of Cor pulmonale and pulmonary hypertension (PHT). Certain therapies which are used for primary PHT are not recommended here (ie. Bosentan..etc)
- Role of Lung volume reduction procedures and how to assess and refer patients, which is criteria driven (FEV1<50%, non-smokers, can manage minimum of 140 M on 6MWT. NICE has already produced specific guideline on the use of endobronchial valves, and coils which can be useful for further reading.11,12
- Lung transplantation: A multidisciplinary team (MDT) is always crucial here, and a criteria was defined for referral. Patients should have stopped smoking before they are considered.

The lay out of this section is slightly different here to the NICE guideline. Anyway, by and large, recommendations are similar regarding palliative care, nutritional support, management of comorbidities.

The section on lung volume reduction and other therapeutic interventions in COPD is quite detailed with a nice flowchart on how the evaluate and refer patients for these interventions.
The criteria for referral to Lung transplantation is slightly different to NICE’s (Bode 5-6, PaCO2> 6.6kPa, PaO2< 8kPa, FEV1, 25%); and there is another criteria defined to list patient on the transplant waiting list. The flowchart mentioned above provides a very useful aid.9

For:
Generally same and largely similar to GOLD, but some areas were a bit clearer.

For:
The clear criteria for referral to lung transplant is very useful to clinicians. The interventional referral flow chart is excellent.

Against:
The section on Lung transplantation and lung volume reduction procedures could have been simplified more!

Against:
Finding some information here can be difficult due to the challenging layout, but once you find it, it is easy to follow.

Follow up

NICE

GOLD

Perhaps not surprisingly NICE emphasises here in ensuring the diagnosis is documented, and spirometry values as well as smoking cessation interventions and considerations for pulmonary rehab are all entered in the care record (and Read codes are used) as these also assist in meeting Quality Outcome Framework (QOF) requirements for primary care.4
NICE recommends 6-12 monthly follow up intervals based on the severity of the disease.4 NICE also suggests that a drop of 500 mls or more in spirometry parameters over 5 years reflect a fast decliner phenotype, and these should be referred to a specialist.4

The general recommendation here is to perform spirometry once per annum to identify fast decliners, but no value cut-points provided here.
There is also emphasis on 6 minute walk test as it can also identify fast decliners.9

The remaining of the recommendation here is very similar to NICE’s.

For:
The table on intervals of follow up and what to do based on the severity is priceless.

For:
No major surprises. Makes use of the 6MWT in identifying fast decliners.9

Against:
Not much!

Against:
Not as simple to follow as it needed to be.


Conclusions

As you note from the above, the two guidelines agree on many points. Things like the role of Spirometry in the diagnosis, evaluating and managing comorbidities, and the role of non-pharmacological interventions. At the same time, there are some significant differences, like the predicted values to be used when performing spirometry, the role of some biomarkers like eosinophils, assessment of the severity of the disease, the role of the BODE index, and how to approach pharmacological therapies. What we do not have, is data to compare implementation, uptake and outcomes of each of these guidelines. In fact, we are unlikely to have this data anytime soon.

So, what do you think is more attractive; “to be NICE, or to wear GOLD”?

References

1. BTS Guidelines for the Management of Chronic Obstructive Pulmonary Disease. Thorax 1997 Dec 52(Suppl 5): 1-1. Available from: https://thorax.bmj.com/content/52/suppl_5/1.long. Accessed April, 2020.
2. NICE, 2004 Available from: https://www.nice.org.uk/guidance/CG12. Accessed April, 2020.
3. Rodriguez-Roisin R. Global Initiative for Chronic Obstructive Lung Disease (GOLD) 20th Anniversary: a brief history of time. Eur Respir J 2017;50:1700671.
4. NICE, 2019. Available from: https://www.nice.org.uk/guidance/ng115/chapter/Recommendations#diagnosing-copd. Accessed April, 2020.
5. Fletcher CM. The Significance of Respiratory Symptoms and the Diagnosis of Chronic Bronchitis in a Working Population. Br Med J 1959;2:257.
6. Quanjer PH. Multi-ethnic Reference Values for Spirometry for the 3-95 year age range: the Global Lung Function 2012 equations Eur Respir J 2012 40:1324-1343.
7. Dodd JW. The COPD Assessment Test (CAT): Response to Pulmonary Rehabilitation. A multicentre, prospective study. Thorax 2011;66:425-429.
8. ERS. Chronic Obstructive Pulmonary Disease. 2013 Available from: https://www.erswhitebook.org/chapters/chronic-obstructive-pulmonary-disease/. Accessed April, 2020.
9. GOLD 2020. Available from: https://goldcopd.org/wp-content/uploads/2019/12/GOLD-2020-FINAL-ver1.2-03Dec19_WMV.pdf. Accessed April, 2020.
10. NICE, 2017. Available from: https://www.nice.org.uk/guidance/TA461. Accessed April, 2020.
11. NICE, 2017. Available from: https://www.nice.org.uk/guidance/ipg600. Accessed April, 2020.
12. NICE, 2015. Available from: https://www.nice.org.uk/guidance/ipg517. Accessed April, 2020.

Professor Nawar Bakerly MD, FRCP has received an honorarium from GSK for developing this article/content.

PM-GB-CPU-WCNT-200004 March 2020

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