The Task Force developed a consensus agreement on a Global Quality Standard for Severe Asthma, including four new Quality Statements, supporting rationale, metrics, and local adaptation guidance to support health care systems and providers in the administration of optimal care for patients with severe asthma. The intended audience includes national/international, regional, and local clinical groups, policymakers, commissioners, and guidelines writers. Figure 2 summarizes the core elements of the Global Quality Standard, and Table 1 summarizes the Quality Statements and their rationales. A detailed summary of each statement along with its supporting rationale, proposed metrics, and local adaptation opportunities follows.
Table 1 Quality Statements and rationales for the Global Quality Standard for the treatment of severe asthma Element 1: Organization of Services
Quality Statement 1
The health care system facilitates effective communication between providers and patients with diagnosed or suspected severe asthma to minimize a patient’s daily symptoms, decrease the risk of asthma exacerbations, improve or reduce future loss of lung function, and reduce the risks of adverse events from OCS and other medications.
Rationale
Individuals with diagnosed or suspected severe asthma, and worsening symptoms or exacerbations, may visit hospitals, emergency departments, urgent care facilities, or other clinical settings. These medical events often have important implications for treatment planning. Effective decision-making requires awareness by every health care provider involved in a given patient’s care of decisions made in other settings that may relate to the well-being and optimal care of the patient.
Essential Criteria, Quality Metrics, and Local Adaptation Opportunities
Criterion 1A: A clear referral network of care providers is required at local, regional, and national levels to connect general practitioners with asthma specialists and prevent delays in diagnosis and treatment.
Potential Metrics
-
(a)
Number of total providers in the referral network.
-
(b)
Percentage of clinicians within the network who specialize in, and are dedicated to, asthma care.
-
(c)
Evidence of referral pathways and multidirectional information flow.
Local Adaptation Opportunities
-
(a)
Provide structural updates to the network of severe asthma care providers (e.g., using a “hub and spoke model” wherein a main campus [“hub”] receives heavier resource investments proportionate to the number of asthma patients served and supplies the most intensive medical services, and is complemented by satellite campuses [“spokes”] that offer more limited services).
-
(b)
Develop a dedicated list of asthma care providers and their specialist areas to be made available to all facilities and health care providers within the network.
-
(c)
Ensure that services and health care providers are covered by the network (e.g., emergency department, community providers/clinics).
-
(d)
Demonstrate evidence of effective communication between health care providers and facilities.
Criterion 1B: An infrastructure that enables real-time sharing of clinical data, including possible alerts when OCS and short-acting beta-agonists (SABA) are prescribed, serious exacerbation events are experienced by a patient, and/or following discharge from a hospital/emergency department.
Potential Metrics
-
(a)
Number of clinicians using the same data infrastructure.
-
(b)
Percentage of patients with asthma seen in the emergency department or admitted to hospital because of an asthma exacerbation, and the severity of their asthma.
-
(c)
Percentage of providers with alerts for OCS prescribing (e.g., more than one prescription in the past year).
-
(d)
Percentage of providers with alerts for SABA prescribing (e.g., more than three prescriptions in the past year).
Local Adaptation Opportunities
-
(a)
Improve information technology solutions to allow clinicians across care settings ready access to clinical documentation relevant to managing a patient with severe asthma.
-
(b)
Standardize data infrastructure across settings to improve access for general practitioners and asthma specialists to maximize consistency of advice and care provided to asthma patients.
-
(c)
Standardize computerized alerts (content and process for delivery), and provide regular and standardized education to clinicians on what and how information will be provided.
Criterion 1C: A validated decision tool to help support informed decision-making by patients regarding their care, and accompanying health care provider support, are used.
Potential Metrics
-
(a)
Percentage of patients using decision tool and availability of translated, adapted, and culturally appropriate versions for diverse populations.
-
(b)
Number of downloads of the decision tool if available electronically.
-
(c)
Annual survey of health care providers to evaluate frequency of dissemination of the decision tool to patients.
Local Adaptation Opportunities
Standardization of content and format of a patient decision tool for use across clinical settings.
Criterion 1D: When a suspected case of severe asthma is identified, the patient is evaluated by a multidisciplinary team (MDT) that can exclude or manage other pathology and provide treatment recommendations for “whole-patient” care.
Potential Metrics
-
(a)
Number of facilities with an MDT available for assessment and management of patients with asthma.
-
(b)
Percentage of facilities with an established protocol for utilizing an MDT for managing patients with asthma.
-
(c)
Percentage of patients with a documented asthma action plan developed with an MDT.
Local Adaptation Opportunities
An MDT may include specialties such as respiratory physicians, clinical nurse specialists, radiologists, pathologists, allergists, physiotherapists, clinical health psychologists, speech and language therapists, dietitians, and clinical pharmacists.
Criterion 1E: Health care providers involved in the care of patients with severe asthma receive updates on the diagnosis, treatment plan, and follow-up plan for these patients.
Potential Metrics
-
(a)
Percentage of providers (general practitioners and specialists) in an MDT receiving an update following a significant change in a patient’s status.
-
(b)
Percentage of general practitioners receiving information related to formal patient diagnosis, relevant investigations undertaken, and treatment plan from the asthma specialist (for initial and subsequent visits, ideally within 2 weeks of the specialty clinic visit).
Local Adaptation Opportunities
-
(a)
Standardize the format of formal diagnosis notification and/or alert.
-
(b)
Health care communities may wish to recommend suggested procedures for evaluating and treating patients with asthma (e.g., recommended tests or investigations, recommended treatment plan structure), and document when data (e.g., images or files) are provided to the patient.
Element 2: Identification and Referral of Suspected Severe Asthma
Quality Statement 2
People with difficult asthma who are unresponsive to optimal standard-of-care therapy are rapidly identified, reviewed, and referred to specialist care.
Rationale
People with diagnosed or suspected severe asthma may not respond to optimal treatment with (inhaled) standard-of-care therapies. The lack of response may be due to poor/suboptimal adherence or insufficient inhaler technique; however, some patients may continue to have severe uncontrolled asthma despite optimized medical management. Regardless of the reason, referral to specialist care is appropriate.
Essential Criteria, Quality Metrics, and Local Adaptation Opportunities
Criterion 2A: Patients with suspected severe asthma are referred to an asthma specialist for assessment (utilizing the established referral network; see criterion 1A, above).
Quality Metrics
-
(a)
Percentage of individuals with uncontrolled asthma on locally agreed or GINA standard of care (stage 4+).
-
(b)
Percentage of patients with suspected severe asthma referred for diagnosis within a prespecified period of time (e.g., a number of months defined locally based on abilities and perspectives of the country/region).
-
(c)
Percentage of patients with suspected severe asthma in the general population who have not been referred to an asthma specialist.
-
(d)
Percentage of patients with asthma in primary care for a prespecified period of time before referral to specialty asthma care (e.g., a number of weeks defined locally based on abilities and perspectives of the country/region).
-
(e)
Percentage of patients with asthma receiving two or more courses of OCS without being managed in a specialty care service.
-
(f)
Percentage of patients with asthma receiving three or more SABA in a 12-month period.
Local Adaptation Opportunities
-
(a)
Generate a list of care settings that can refer to specialty care (e.g., general practice, secondary care, emergency department, community, urgent care), and implement a system to facilitate timely referral.
-
(b)
Provide education about the role of patient self-referral for specialty asthma care.
-
(c)
Establish local criteria for identification of suspected severe asthma.
-
(d)
Establish local guidelines on markers of asthma control, including thresholds for OCS usage and SABA prescribing patterns that should trigger specialty referral.
-
(e)
Establish local triggers for specialty referral (e.g., maximum threshold of OCS use, number of emergency department or urgent care visits within a defined time frame).
-
(f)
Establish waiting time targets and thresholds for maximum time a patient with uncontrolled asthma should be managed in primary care.
-
(g)
Availability of established guidelines to support clinicians with tapering strategies for corticosteroids, and exemptions.
Criterion 2B: Local leadership establishes a list of clinical assessment and investigation tools to disseminate to clinicians to improve identification of severe asthma, and implement when severe asthma is suspected.
Quality Metrics
Percentage of patients with suspected severe asthma with documented completion of locally agreed upon clinical assessments/investigations within a prespecified period of time (e.g., a number of weeks defined locally based on abilities and perspectives of the country/region).
Local Adaptation Opportunities
Generate a standardized list of clinical assessment and investigation tools and disseminate to clinicians/clinics for reference and implementation in practice.
Criterion 2C: Clinics/facilities have an asthma “champion” who is a peer leader/clinician trained in asthma assessment and management and receives ongoing support from the facility to serve in the role of change agent. The asthma champion is responsible to ensure asthma care standards are maintained, including availability and use of recommended tests and procedures, and continuing medical education (CME) is provided for all clinical staff treating patients with asthma.
Quality Metrics
-
(a)
Percentage of health care providers with local access to an asthma champion in their facility/clinic.
-
(b)
Percentage of clinical staff by practice type/discipline receiving asthma-specific CME credits in a 12-month period.
Local Adaptation Opportunities
-
(a)
Clarify scope of staff members and organizational involvement to support maintenance of standards and achievement of continuing education guidelines.
-
(b)
Standardize CME content and format.
-
(c)
Pursue accreditation for training curriculum to allow provision of formal CME credits to incentivize providers to complete training.
-
(d)
Establish a timeline for CME refresher courses.
Element 3: Management of Severe Asthma
Quality Statement 3
People with suspected severe asthma referred to specialists or other trained health care professionals will undergo a phenotype assessment to optimize asthma medications and promote precision-medicine-based care, thus increasing the chances of improving clinical outcomes.
Rationale
The underlying biologic drivers of severe asthma vary by patient, and are paramount to identification of severe asthma phenotypes. Understanding the biologic drivers of disease, and the key biomarkers that may better predict a patient’s response to an individual therapy, is critical to optimize patient care and deliver superior clinical outcomes.
Essential Criteria, Quality Metrics, and Local Adaptation Opportunities
Criterion 3A: Individuals with severe asthma receive assessment for personalized phenotype-based treatment.
Quality Metrics
-
(a)
Percentage of patients receiving biomarker tests.
-
(b)
Percentage of health care providers with access to and who are utilizing tools required to properly assess phenotype, which should include, at a minimum:
-
i.
Blood eosinophil (EOS) tests.
-
ii.
Fractional exhaled nitric oxide (FeNO).
-
iii.
Total immunoglobulin E (IgE).
-
iv.
Spirometry.
-
(c)
Percentage of patients receiving phenotype assessment, which should include, at a minimum, the tools/tests listed above.
Local Adaptation Opportunities
-
(a)
Optimize the type of clinicians involved in assessment planning and interpretation.
-
(b)
Standardize time to phenotype assessment.
-
(c)
Centralize testing location.
Criterion 3B: Maintenance OCS should be considered an option of last resort, reserved only for patients who are ineligible for, or do not have access to (e.g., because of location, cost, or insurance coverage) biologic therapies.
Quality Metrics
-
(a)
Percentage of patients receiving, or initiated on, maintenance OCS.
-
(b)
Percentage of patients on maintenance OCS who have documented evidence of adherence to inhaled medications.
-
(c)
Percentage of patients on maintenance OCS who are prescribed and take OCS-sparing agents.
Local Adaptation Opportunities
-
(a)
Establish local guidelines and tools to limit use of maintenance OCS.
-
(b)
Establish local guidelines and tools to limit use of OCS in patients with newly identified asthma.
-
(c)
Evaluate the total number of patients on maintenance OCS (e.g., via an annual report).
Criterion 3C: For patients currently taking OCS, the asthma action plan will include development of a corticosteroid-sparing strategy.
Quality Metrics
-
(a)
Percentage of asthma action plans that include reference to OCS-sparing strategies.
-
(b)
Percentage of patients with reduced use of OCS (within a 12-month cycle).
-
(c)
Percentage of patients prescribed biologics for asthma maintenance care.
Local Adaptation Opportunities
-
(a)
Develop local approaches and tools to support standard inclusion of OCS-sparing strategies as a standard in every asthma action plan.
-
(b)
Develop and disseminate exemption criteria as guidance for network providers.
Element 4: Patient-Centric Care
Quality Statement 4
Treatment decisions are made in partnership between the patient and clinician, and reflect the patient’s expectations, priorities, and values. The impact of treatment is regularly reviewed and tracked in a personalized asthma action plan.
Rationale
The goals of management of severe asthma are to reduce the risk of severe exacerbations and improve daily symptom control. Clinicians are reminded of the need to treat the person, not the diagnosis, with consideration of comorbid conditions and psychosocial factors. With the increased number of “informed patients,” shared decision-making is more likely to lead to better clinical outcomes.
As severe asthma is a chronic, variable condition, periodic reviews are reasonable to assess whether the condition has changed, to consider if alternative intervention is appropriate, and to offer ongoing education, training, and support. Like most chronic conditions, asthma is associated with various physical and psychosocial sequelae and comorbidities. Tracking and documenting comprehensive changes as part of a dedicated asthma action plan ensures that all providers involved in the care of a patient with severe asthma can offer the most informed care.
Essential Criteria, Quality Metrics, and Local Adaptation Opportunities
Criterion 4A: Patients with severe asthma receive relevant information and education sufficient to support participation in shared decision-making.
Quality Metrics
-
(a)
Percentage of severe asthma patients offered personalized information related to their types of severe asthma at the time of their formal diagnoses, and at follow-up visits.
-
(b)
Evaluate perceived value (to patients) of providing personalized information about asthma during clinic visits.
-
(c)
Percentage of clinical staff with up-to-date education and training to support shared decision-making.
Local Adaptation Opportunities
-
(a)
Standardize the format and provision of patient information. For example:
-
i.
If education is to be provided in a formal educational program/lecture, standardize content, recruitment, and staff delivering materials to patients and families.
-
ii.
If education is provided during informal personalized clinical conversations with a health care provider, standardize the information to be provided/reviewed.
-
iii.
If handouts or leaflets are used, ensure the printed information is updated with the most recent best practice data and is appropriate for the population served (e.g., appropriate reading level, language, alternative formats for persons with unique learning challenges or disabilities).
-
iv.
Standardize the scope of information included in patient education materials according to consensus among experts in severe asthma networks, while ensuring adapted, translated, and culturally appropriate versions are available for diverse populations in a format personalized for each patient/family.
Criterion 4B: Patients with severe asthma receive a periodic review of their condition and the impact of management approaches on outcomes.
Quality Metrics
-
(a)
Percentage of patients receiving periodic follow-up for their asthma.
-
(b)
Percentage of patients attending asthma review appointments with an asthma specialist.
-
(c)
Percentage of asthma reviews that include an assessment of psychosocial issues and function, in addition to comorbidities.
-
(d)
Additional agreed upon parameters for review (e.g., level of symptom control, ED visits, hospital admissions, lung function, inhaler technique review, frequency of use of preventer and reliever medications) that are documented in the patient medical record.
Local Adaptation Opportunities
-
(a)
Establish protocols to standardize the regularity of periodic review with patients.
-
(b)
Establish protocols to standardize an explicit process of managing patients who fail to attend specialist asthma review visits.
-
(c)
Establish local protocols for inclusion of psychosocial issues in periodic review with patients.
Criterion 4C: Criteria for a periodic review will be established by local clinical leadership, and published for easy access and use by local clinical providers (i.e., “A periodic review should include…” with criteria to be explicitly documented by the local leadership).
Quality Metrics
Percentage of locally agreed review criteria conducted/completed in the specified time frame.
Local Adaptation Opportunities
Criteria constituting a periodic review may include:
-
i.
Measurement of asthma and/or symptom control.
-
ii.
Inhaler technique assessment and review.
-
iii.
Recording of exacerbation treatment and frequency of need for steroids.
-
iv.
Number of emergency department visits.
-
v.
Number of hospital admissions.
-
vi.
Treatment adherence.
-
vii.
Avoidance of adverse effects.
-
viii.
Prompts for prescription refills.
-
ix.
Prompts for vaccinations.
-
x.
FeNO, spirometry, and blood EOS tests.
-
xi.
Tobacco use/smoking behavior.
-
xii.
Exercise behavior.
Criterion 4D: Patients have a dedicated asthma action plan in which changes and decisions related to their asthma care are integrated and well documented.
Quality Metrics
Percentage of patients with a personalized asthma action plan reflective of care needs, including personalized contact with health care professionals for advice, counsel, and shared decision-making opportunities.
Local Adaptation Opportunities
-
(a)
Establish criteria to standardize asthma action plan format and content.
-
(b)
Establish criteria for updating the asthma action plan.
Criterion 4E: Patient records are owned by the patient and available to health care professionals involved in the patient’s care.
Quality Metrics
-
(a)
Percentage of organizations involved in care of patients with severe asthma that are able to access patient medical records, including the asthma action plan.
-
(b)
Percentage of patients with access to, or in possession of, their own medical records.
-
(c)
Percentage of patients sharing their medical record data with members of the MDT.
Local Adaptation Opportunities
Expand the scope of accessibility of patient data sharing.
-
i.
Health care professionals in the MDT should be able to easily access relevant medical information for their patient with severe asthma. Reducing barriers to access allows for greater personalization of the health care experience. However, access history is auditable to ensure protection of patient privacy.
-
ii.
Patients should have easy access to their medical records, preferably available in an easily understandable format. Patients should be given the opportunity to discuss data contained in the medical record with a professional who can assist them in interpreting and understanding information, particularly in cases in which learning, reading, or cognitive capacity may be limited.