Summary of NICE BTS SIGN Guidelines for Asthma Diagnosis and Monitoring published on the 27^th November 2024 (Using the Bedfont® NObreath® device as the device of choice for FeNO testing)

 

The British Thoracic Society (BTS), National Institute for Health and Care Excellence (NICE), and the Scottish Intercollegiate Guidelines Network (SIGN) have collaboratively developed guidelines aimed at enhancing the diagnosis, monitoring, and management of asthma for adults, young people over 16, and children aged 5 to 16. These guidelines emphasise the pivotal role of Fractional Exhaled Nitric Oxide (FeNO) testing, supported by changes in the Quality and Outcomes Framework (QOF) indicators and a detailed financial analysis highlighting the cost-effectiveness of FeNO testing. Implementing the Bedfont® NObreath® device as the primary FeNO testing tool offers an accurate, easy-to-use, and financially viable solution to comply with these guidelines.

 

1. Initial Clinical Assessment

A thorough clinical assessment remains fundamental to diagnosing asthma. Healthcare professionals should carefully document the patient's medical history, focusing on symptoms such as wheezing, shortness of breath, chest tightness, and cough. These symptoms are often variable and triggered by allergens, physical activity, or environmental factors. A detailed family history of asthma or related atopic conditions should also be explored. Physical examination may reveal signs such as wheezing, which indicate airflow obstruction.

 

2. Objective Tests for Diagnosing Asthma

Objective tests confirm asthma by providing measurable evidence of airway inflammation and lung function variability. The Bedfont® NObreath® device aligns with the guidelines by offering a precise and user-friendly approach to FeNO measurement, streamlining the diagnostic process in primary care.

 

2.1. Adults and Young People Over 16

The diagnostic algorithm for adults and young people involves the following steps:

 

FeNO Testing

FeNO testing is prioritised as the first-line objective test. Using the Bedfont® NObreath® device, healthcare professionals can accurately measure FeNO levels. A result of 50 parts per billion (ppb) or higher indicates eosinophilic airway inflammation, supporting an asthma diagnosis.

 

Blood Eosinophil Count

If FeNO testing is unavailable, a blood eosinophil count can serve as a supporting diagnostic measure. Elevated levels above the laboratory reference range indicate asthma.

 

Bronchodilator Reversibility (BDR) Testing with Spirometry

Spirometry measures lung function, and BDR testing assesses reversibility after administering a bronchodilator. An increase in Forced Expiratory Volume in one second (FEV₁) of 12% or more and at least 200 ml supports an asthma diagnosis.

 

Peak Expiratory Flow (PEF) Variability

If spirometry is unavailable, PEF monitoring can assess variability. A PEF amplitude percentage mean of 20% or more is consistent with asthma.

 

Bronchial Challenge Test

If all prior tests are inconclusive, a bronchial challenge test evaluates airway hyperresponsiveness. A positive result confirms asthma.

 

2.2. Children Aged 5 to 16

Diagnostic steps for children are adapted to their developmental stage:

 

FeNO Testing

The Bedfont® NObreath® device enables non-invasive, child-friendly FeNO testing. A result of 35 ppb or more supports an asthma diagnosis in children.

 

Bronchodilator Reversibility (BDR) Testing with Spirometry

Spirometry with BDR testing assesses reversible airway obstruction. The criteria for reversibility are the same as for adults.

 

Peak Expiratory Flow (PEF) Variability

If spirometry is unavailable, PEF monitoring supports a diagnosis when variability exceeds 20%.

 

Allergy Testing

Skin prick tests or total Immunoglobulin E (IgE) measurement identify allergic sensitisation, particularly to common allergens like house dust mites.

 

Blood Eosinophil Count

If IgE levels are elevated, blood eosinophil levels above 0.5 x 10⁹ per litre support asthma diagnosis.

 

Referral to a Specialist

If diagnostic uncertainty persists, referral to a paediatric respiratory specialist is recommended. Further tests, such as a bronchial challenge test, may be conducted.

 

3. Role of FeNO Testing

FeNO testing is a non-invasive, reliable method that measures the concentration of nitric oxide in exhaled breath, serving as a biomarker for eosinophilic inflammation. Using the Bedfont® NObreath® device provides the following benefits:

 

Early Detection

FeNO levels rise before symptoms, facilitating earlier intervention.

 

Monitoring Inflammation

Regular FeNO measurements using NObreath® help monitor airway inflammation, guiding treatment adjustments.

 

Predicting Steroid Responsiveness

Elevated FeNO levels predict a positive response to corticosteroid treatment, enabling personalised therapy.

 

Prioritising FeNO testing in diagnostic pathways improves accuracy and allows for targeted treatment strategies.

 

4. Financial Implications of FeNO Testing

The NICE resource impact summary report highlights the cost-effectiveness of FeNO testing. The Bedfont® NObreath® device enhances these benefits by offering a financially viable solution:

 

Cost-Effectiveness

FeNO testing with the NObreath® device reduces unnecessary treatments and misdiagnosis, avoiding costs associated with inappropriate medication or referrals.

Its affordability ensures widespread adoption in primary care settings.

 

Savings in Secondary Care Referrals

The resource report estimates that implementing FeNO testing significantly reduces referrals to secondary care, easing the burden on specialised services.

 

Impact on Hospital Admissions

The accurate diagnostic capabilities of NObreath® lead to fewer emergency hospitalisations, saving direct and indirect costs.

 

Sustainability

The NObreath® device is designed to be durable and cost-efficient, ensuring long-term value for clinics adopting FeNO testing.

 

5. Changes to QOF Indicators

To support implementation, the QOF indicators have been updated:

 

Emphasis on Objective Testing

Practices are incentivised to use and record objective diagnostic tests, including FeNO testing with NObreath®, to standardise care.

 

Facilitating FeNO Uptake

The NObreath® device simplifies FeNO testing, making it more accessible for primary care clinics to comply with updated QOF indicators.

 

Improved Reporting and Monitoring

Practices are rewarded for detailed reporting on diagnostic methods and patient outcomes, ensuring adherence to guidelines.

 

6. Monitoring Asthma Control

Effective asthma management requires ongoing monitoring. The NObreath® device simplifies routine FeNO testing, enabling a comprehensive view of asthma control when combined with:

 

Symptom Review

Assess frequency and severity of symptoms and their impact on daily activities.

 

Medication Adherence and Technique

Verify adherence to prescribed medications and correct inhaler use.

 

Action Plans

Develop and review personalised asthma action plans, ensuring patients understand when and how to seek medical help.

 

7. Recommendations for Primary Care Clinics assuming the adoption of the Bedfont® NObreath® FeNO testing device.

To optimise asthma diagnosis and management:

Adopt the Bedfont® NObreath® Device

Equip clinics with the NObreath® device, prioritising it as the first diagnostic tool for FeNO testing.

Streamline Diagnostic Pathways

Adapt NICE algorithms into clear, user-friendly charts for clinic staff.

Provide Education

Train healthcare teams on using the NObreath® device and raise patient awareness of evidence-based asthma care.

Evaluate Outcomes

Monitor diagnostic accuracy and treatment effectiveness, using these insights to refine practices.

 

References

NICE Guideline NG245: Asthma Diagnosis and Monitoring

NICE Resource Impact Report on FeNO Testing

QOF Indicator Framework for Asthma Objective Tests

Bedfont® NObreath® Device Specifications and Financial Analysis based on current pricelist as of 3^rd Dec 2024

2011 - Kapande et al. - Comparative Repeatability of Two Handheld Fractional Exhaled Nitric Oxide Monitors

 

Implementation of NObreath® FeNO Testing in Primary Care

The Bedfont® NObreath® FeNO monitor is a non-invasive, reliable, and cost-effective device designed to measure Fractional Exhaled Nitric Oxide (FeNO) levels for diagnosing and monitoring asthma. Integrating NObreath® into primary care settings ensures compliance with NICE guidelines and optimises asthma diagnosis and management.

1. Preparation for Implementation

a. Clinic Setup

Designate a clinical area for FeNO testing.

Ensure access to a stable power source or charged device batteries.

Maintain a supply of disposable mouthpieces to ensure hygiene and prevent cross-contamination.

 

b. Staff Training

Train healthcare professionals on how to use the NObreath® device, interpret results, and communicate findings to patients.

Provide practical sessions to build staff confidence in performing the test.

Educate staff on asthma pathways to integrate FeNO testing effectively into the diagnostic process.

 

c. Device Calibration and Maintenance

Follow the manufacturer’s guidelines for device calibration and service.

Conduct regular maintenance to ensure accurate readings.

Check the expiration dates on consumables like mouthpieces and replace as needed.

 

2. Conducting the FeNO Test

 

Prepare the Patient

Explain the purpose and process of the FeNO test to the patient.

Ask the patient to avoid eating, drinking, smoking, or exercising 1–2 hours before the test to prevent skewed results.

Ensure the patient is relaxed and seated comfortably.

 

Administer the Test

Attach a disposable mouthpiece to the NObreath® device.

Instruct the patient to take a deep breath, hold it for a few seconds, and then exhale slowly and steadily into the mouthpiece.

Monitor the exhalation process using the device’s display and the on-screen incentives, ensuring the patient maintains a consistent flow rate.

 

Record the Result

The NObreath® device will display the FeNO concentration in parts per billion (ppb) immediately after the test is completed.

Document the result in the patient’s records.

 

Interpret the Results

For Adults (≥17 years):

FeNO ≥50 ppb suggests significant eosinophilic inflammation and supports an asthma diagnosis.

FeNO <25 ppb makes asthma less likely but requires further clinical correlation.

 

For Children (5–16 years):

FeNO ≥35 ppb indicates eosinophilic inflammation.

FeNO <20 ppb suggests asthma is less likely.

 

Patient Follow-Up

Discuss results with the patient and outline the next steps.

Incorporate findings into the asthma diagnostic pathway, considering other objective tests and clinical history.

 

3. Integrating NObreath® into Diagnostic Pathways

Adopt NICE Guidelines

Ensure that NObreath® is used as the first-line diagnostic test, followed by spirometry and other investigations when needed.

 

Streamline Workflow

Incorporate FeNO testing into routine asthma diagnostic appointments to minimise additional patient visits.

 

Electronic Health Record (EHR) Integration

Record FeNO results directly into the patient’s EHR system, linking to diagnostic and management plans.

 

Regular Audits

Conduct periodic reviews to ensure consistent and appropriate use of FeNO testing and adherence to guidelines.

 

4. Financial and Operational Considerations

Cost Management

 

Use NObreath® disposable mouthpieces to maintain low running costs.

Leverage the cost-effectiveness of NObreath® to reduce unnecessary treatments and specialist referrals.

 

Reimbursement and QOF Incentives

Record and report FeNO testing under QOF asthma indicators to qualify for reimbursement and incentives.

 

Patient Awareness

Educate patients on the role of FeNO testing in asthma diagnosis and management, building trust and compliance.

 

5. Addressing Challenges creating a financial case for the implantation of FeNo testing with the Bedfont® NObreath®

 

Resistance to Adoption

 

Highlight the financial benefits as shown in the NICE guidance and improved patient outcomes linked to FeNO testing.

Highlight the possibility of low-cost access to the monitor via rental scheme of the NObreath® device and lower cost per test when compared to other systems.

Share success stories and case studies available demonstrating the effectiveness of the NObreath® device in practice (data available upon request).

 

Dealing with Staff Reluctance

 

Address concerns through training, ensuring staff are confident and comfortable using the device. Unlike spirometry FeNO testing requires no ARTP certification and training resources are readily available or will be provided to allow no limitations or delays in offering the test.

It is a test that has a higher compliance by the patients as it is a much easier mauver than spirometry and is performed in minutes allowing to be completed in a single patient appointment.

 

6. Monitoring and Evaluation

 

Clinical Outcomes

Track diagnostic accuracy, patient outcomes, and treatment changes influenced by FeNO results.

 

Cost Savings

Monitor reductions in referrals to secondary care, hospital admissions, and inappropriate medication use.

 

Patient Satisfaction

Use patient feedback to assess the ease and comfort of the testing process and its impact on their asthma management.

 

The Bedfont® NObreath® device is an ideal solution for implementing FeNO testing in primary care. Its ease of use, accuracy, and affordability align with NICE guidelines, supporting evidence-based asthma diagnosis and monitoring. With proper planning, training, and integration, NObreath® can transform asthma care, improving patient outcomes and reducing healthcare costs.

 

References

NICE Guideline NG245: Asthma Diagnosis and Monitoring

NICE Resource Impact Report on FeNO Testing

QOF Indicator Framework for Asthma Objective Tests

Bedfont® NObreath® Device Specifications, User Manual and Financial Analysis based on current pricelist as of 3^rd Dec 2024

 

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