COMMENTARY

Global Quality Standard for Identificationand Management of Severe Asthma

John Haughney . Tonya A. Winders . Steve Holmes . Pascal Chanez .

Hannah Saul . Andrew Menzies-Gow on behalf of the PRECISION Improve Access to Better Care Task Force

Received: June 18, 2020 / Published online: July 28, 2020� The Author(s) 2020

ABSTRACT

Introduction: Severe asthma is a debilitating,life-threatening disease associated with sub-stantial global morbidity, mortality, and healthcare resource utilization. Patients may notreceive guideline-directed medical care for sev-ere asthma. Moreover, viable precision-basedassessment tools and newer preventive thera-pies that can reduce the frequency of exacer-bations and associated functional impact areunderused. As a result, high rates of poorly

controlled severe asthma persist, and patienthealth-related quality of life suffers.Methods: In 2019, the Improve Access to BetterCare Task Force of the PRECISION SteeringCommittee set out to develop a global templateon quality standards for severe asthma care tosupport improved access to and delivery ofquality care. This Quality Standard is groundedin the vast body of published evidence availablefor severe asthma care, published clinicalguidelines (i.e., from the Global Initiative forAsthma in 2019 and the European RespiratorySociety/American Thoracic Society in 2014),and the 2018 PRECISION-supported Charter toImprove Patient Care in Severe Asthma.Results: The Quality Standard developedemphasizes four key elements aimed at opti-mizing clinical care and outcomes in severeasthma: (1) organization of services, (2) timelyidentification and referral for suspected severeasthma, (3) specialized assessment and man-agement of severe asthma to optimize out-comes, and (4) patient-centric care and shareddecision-making that is reflective of thepatient’s expectations, priorities, and values.Four key Quality Statements are provided, alongwith quality metrics and strategies for localadaptation to optimize implementation.Conclusion: This Global Quality Standard isintended to mobilize policymakers, health careproviders, and patient advocacy groups to buildconsensus on the definition and expectations ofquality care in severe asthma, to promote

Digital Features To view digital features for this articlego to https://doi.org/10.6084/m9.figshare.12656966.

J. Haughney (&)Glasgow Clinical Research Facility, Queen ElizabethUniversity Hospital, Glasgow, UKe-mail: j.haughney@abdn.ac.uk

T. A. WindersAllergy & Asthma Network, Vienna, VA, USA

S. HolmesPark Medical Practice, Shepton Mallet, UK

P. ChanezAix Marseille Universite, Clinique des bronches,Allergie Et Sommeil/APHM, Marseille C2VN CenterINSERM INRA UMR1062, Marseille, France

H. SaulAstraZeneca, Cambridge, UK

A. Menzies-GowRoyal Brompton and Harefield NHS FoundationTrust, London, UK

Adv Ther (2020) 37:3645–3659

https://doi.org/10.1007/s12325-020-01450-7

patient-centric care, to identify gaps in care andareas for improvement, and systematicallyimplement improvement measures and out-comes and to reduce the burden of illness forpatients with severe asthma.

PLAIN LANGUAGE SUMMARY

Although only 10% of patients with asthmahave severe disease, these patients use up to halfof all health care resources used to treat asthma.For the patient, severe asthma is associated withsubstantial morbidity, increased risk of death,and poor quality of life. Effective treatments forsevere asthma are available, yet access to thesetreatments varies for many patients around theglobe, and they are not always used effectivelywhen available. A task force of leading globalasthma experts was recently assembled todevelop global standards to support improvedaccess and delivery of quality care for patientswith severe asthma. The task force identifiedfour key elements to optimize management andoutcomes: (1) coordination of services, (2)timely detection and referral of patients withsevere asthma, (3) use of guideline-recom-mended assessments and therapies, and (4)integration of patient expectations and valueswhen making treatment decisions. This QualityStandard details each of these elements by pro-viding supporting rationale, ways to measureimprovements in each area, and strategies toimplement these elements at local clinicsaround the world. Ultimately, this QualityStandard is intended to help policymakers,health care providers, patient advocacy groups,and other key stakeholders build consensus onthe requirements for quality care in severeasthma to improve patient care while alsoreducing the overall global burden of severeasthma.

Keywords: Guideline-directed medicaltherapy; Health care policy; Patient advocacy;Patient care; Quality care standards; Riskreduction; Severe asthma

Key Summary Points

Why carry out the study?

Patients with severe asthma use morehealth care resources, have more impairedwell-being and quality of life, and dieearlier than people in the generalpopulation

Poor health outcomes, overall negativeeffects on everyday life, and risk of deathcan increase when guidelines intended toimprove medical care are not followed

The Improve Access to Better Care TaskForce of the PRECISION SteeringCommittee was created to developworldwide standards for managing severeasthma to help improve patient care

What was learned from the study?

A Quality Standard was developed as aguide to encourage key stakeholders topromote early identification and diagnosisof severe asthma, decrease delays toreferral to specialists when cases aresuspected, and result in effectivemanagement of severe asthma oncediagnosed, with a particular focus onpatient needs

Quality Statements, quality metrics, andlocal strategies are proposed to encourageeffective use of these tactics to improvehealth care practices for patients withsevere asthma

INTRODUCTION

Asthma is among the most commonly occurringnon-communicable diseases, affecting approxi-mately 339 million people worldwide [1], and isa substantial source of morbidity and mortality.Despite the availability of effective treatments,asthma ranks 16th among leading causes ofyears of life lived with disability [2] and 28th

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among leading causes of burden of disease [3].Although severe asthma constitutes only about10% of total asthma cases, these patients expe-rience substantial burden of illness and accountfor up to 50% of asthma-related health careresources used [4]. Many patients are unable toaccess or afford needed care, contributing to theestimated 1000 people who die of asthma eachday around the world [1]. Preventable asthmadeaths continue to occur as a result of inap-propriate management, including over-relianceon reliever medications, underutilization ofpreventive medications, and lack of under-standing/awareness of available biomarkers tohelp personalize treatment decisions to opti-mize outcomes, particularly in patients withsevere asthma [5–7].

Careful assessment of the suspected severeasthma patient is critical to determining theappropriate plan of care, as acute respiratorysymptoms may be explained by alternative, orcomorbid, conditions in some cases and requiretargeted intervention other than escalatedasthma therapy [8]. When escalated asthma careis required, guideline-directed medical therapy(GDMT) is not widely implemented, and clini-cians experience challenges staying abreast ofevolving guidelines. For instance, Global Ini-tiative for Asthma (GINA) recently published anupdate to its recommendations that, after50 years as first-line care, short-acting b-agonist(SABA)-only is no longer recommended as ini-tial therapy because of growing awareness ofsevere exacerbation risk [9]. GINA also recentlybegan recommending increased caution whenusing add-on oral corticosteroids (OCS), basedon increasing evidence of OCS-related adverseeffects, coupled with the availability of OCS-sparing biologic therapies [9, 10]. Unfortu-nately, despite this update OCS use remainshigh [11]. While access to and especially thecost of newer therapies are significant barriers,limited awareness, understanding, or willing-ness to use biologic therapies introduced duringthe past several years may also underlie thedelay in shifting away from the reliance onOCS.

Poor asthma management results inincreased health care utilization and cost perpatient [12], and lack of standardization in care

is especially problematic for patients with severeasthma. Limited effectiveness of usual standardsof care in preventing exacerbations that resultin significant impairments in function andhealth-related quality of life (HRQOL) drive thisincrease in illness burden. While treatment forsevere asthma may be up to five times moreexpensive than treatment for mild asthma inout-of-pocket costs [12], high-dosage OCScommonly used in these patients are associatedwith a high risk for short- and long-term adverseevents, additional medical complications, andultimately greater societal costs. Action is nee-ded to address the unnecessary burden andpremature mortality associated with severeasthma.

As outlined in the PRECISION-supportedCharter to Improve Patient Care in Severe Asthma[13], patients with asthma should have access toearly identification and diagnosis, timely refer-ral for specialty care, appropriate treatment, andongoing management and follow-up toimprove outcomes, reduce cost and burden, andimprove quality of life regardless of where theylive (Fig. 1). That document served as a guide tothe Improve Access to Better Care Task Force ofthe PRECISION Global Steering Committee (theTask Force) in the development of a globalposition on the standard of care for the man-agement of severe asthma. This Global QualityStandard is intended to be a stimulus and guidefor key stakeholders (e.g., governments, clinicalleaders, policymakers, guideline writers, payers,advocacy groups) to help optimize implemen-tation of care that allows for the early identifi-cation and diagnosis of severe asthma, timelyreferral to severe asthma specialists, and opti-mal treatment and ongoing management prac-tices (Fig. 1).

METHODS

Aims

This design of the Global Quality Standard wasinformed by several considerations. First, Qual-ity Standards should be practical and of directuse to clinicians, policymakers, commissioners,guideline writers, journalists, patient charity

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and advocacy groups, and asthma patients.Second, while aspirational, these standardsshould also be achievable by most well-equip-ped health care systems in developed countries.For optimal success, standards must be tailoredto local requirements; therefore, national andlocal clinical groups worldwide must agree toand interpret standards for successful imple-mentation. Accordingly, an implementationplan should be agreed upon by local leaders,and progress regarding process, outcomes, anduptake must be measured locally. Finally, thisinitiative is intended to allow for the compar-ison of standards achieved across health caresystems, and to support the continual develop-ment and improvement of these systems tosupport improved patient care and outcomes.To that end, this document proposes both a listof potential metrics and areas in which local-ization is required to ensure optimal engage-ment and uptake. This article is based on TaskForce consensus and does not contain anystudies with human participants or animalsperformed by any of the authors.

Standard Development

The Task Force convened in January 2019 tosupport the development of a global positionregarding the clinical management of patientswith severe asthma for use by national and localclinical groups. During the course of six TaskForce meetings and interim communicationsthroughout 2019, consensus was gained for theGlobal Quality Standard for Severe Asthmasummarized here. The four agreed upon QualityStatements, along with their supporting ratio-nale and quality metrics to support local

adaptation and implementation, are detailedbelow. This Quality Standard is based on therecently updated and empirically driven globalclinical guidelines [9], as well as leading respi-ratory society recommendations for severeasthma care [14] and the PRECISION-supportedCharter to Improve Patient Care in Severe Asthma[12], The severe asthma patient charter outlinespatients’ expectations and their rights to bettercare [13].

For the purposes of these standards, a diag-nosis of severe asthma (or suspected severeasthma) is defined as asthma of sufficientseverity to require the combination of high-dosage inhaled corticosteroids and long-actingbeta-agonists, and additional therapies or OCSto prevent the condition from becominguncontrolled [9, 14].

RESULTS

The Task Force developed a consensus agree-ment on a Global Quality Standard for SevereAsthma, including four new Quality State-ments, supporting rationale, metrics, and localadaptation guidance to support health caresystems and providers in the administration ofoptimal care for patients with severe asthma.The intended audience includes national/inter-national, regional, and local clinical groups,policymakers, commissioners, and guidelineswriters. Figure 2 summarizes the core elementsof the Global Quality Standard, and Table 1summarizes the Quality Statements and theirrationales. A detailed summary of each state-ment along with its supporting rationale,

Fig. 1 The scope of the Global Quality Standard encompasses principles to address the unmet need and burden in severeasthma, with the intent to deliver improved care for patients with severe asthma

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proposed metrics, and local adaptation oppor-tunities follows.

Element 1: Organization of Services

Quality Statement 1The health care system facilitates effectivecommunication between providers and patientswith diagnosed or suspected severe asthma tominimize a patient’s daily symptoms, decreasethe risk of asthma exacerbations, improve orreduce future loss of lung function, and reducethe risks of adverse events from OCS and othermedications.

RationaleIndividuals with diagnosed or suspected severeasthma, and worsening symptoms or exacerba-tions, may visit hospitals, emergency depart-ments, urgent care facilities, or other clinicalsettings. These medical events often haveimportant implications for treatment planning.Effective decision-making requires awareness byevery health care provider involved in a givenpatient’s care of decisions made in other set-tings that may relate to the well-being andoptimal care of the patient.

Essential Criteria, Quality Metrics, and LocalAdaptation OpportunitiesCriterion 1A: A clear referral network of careproviders is required at local, regional, andnational levels to connect general practitionerswith asthma specialists and prevent delays indiagnosis and treatment.

Potential Metrics

(a) Number of total providers in the referralnetwork.

(b) Percentage of clinicians within the net-work who specialize in, and are dedicatedto, asthma care.

(c) Evidence of referral pathways and multidi-rectional information flow.

Local Adaptation Opportunities

(a) Provide structural updates to the networkof severe asthma care providers (e.g., usinga ‘‘hub and spoke model’’ wherein a maincampus [‘‘hub’’] receives heavier resourceinvestments proportionate to the numberof asthma patients served and supplies themost intensive medical services, and iscomplemented by satellite campuses[‘‘spokes’’] that offer more limited services).

(b) Develop a dedicated list of asthma careproviders and their specialist areas to bemade available to all facilities and healthcare providers within the network.

(c) Ensure that services and health care provi-ders are covered by the network (e.g.,emergency department, communityproviders/clinics).

(d) Demonstrate evidence of effective commu-nication between health care providersand facilities.

Criterion 1B: An infrastructure that enablesreal-time sharing of clinical data, includingpossible alerts when OCS and short-acting beta-agonists (SABA) are prescribed, serious

Fig. 2 The Global Quality Standard for improved management of severe asthma, as developed by the Improve Access toBetter Care Task Force of the PRECISION Steering Committee, consists of four core elements. See Table 1 for more detail

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exacerbation events are experienced by apatient, and/or following discharge from ahospital/emergency department.

Potential Metrics

(a) Number of clinicians using the same datainfrastructure.

(b) Percentage of patients with asthma seen inthe emergency department or admitted tohospital because of an asthma exacerba-tion, and the severity of their asthma.

(c) Percentage of providers with alerts for OCSprescribing (e.g., more than one prescrip-tion in the past year).

(d) Percentage of providers with alerts forSABA prescribing (e.g., more than threeprescriptions in the past year).

Local Adaptation Opportunities

(a) Improve information technology solutionsto allow clinicians across care settingsready access to clinical documentationrelevant to managing a patient with severeasthma.

(b) Standardize data infrastructure across set-tings to improve access for general practi-tioners and asthma specialists to maximize

consistency of advice and care provided toasthma patients.

(c) Standardize computerized alerts (contentand process for delivery), and provideregular and standardized education to clin-icians on what and how information willbe provided.

Criterion 1C: A validated decision tool to helpsupport informed decision-making by patientsregarding their care, and accompanying healthcare provider support, are used.

Potential Metrics

(a) Percentage of patients using decision tooland availability of translated, adapted, andculturally appropriate versions for diversepopulations.

(b) Number of downloads of the decision toolif available electronically.

(c) Annual survey of health care providers toevaluate frequency of dissemination of thedecision tool to patients.

Local Adaptation Opportunities Standardiza-tion of content and format of a patient decisiontool for use across clinical settings.

Table 1 Quality Statements and rationales for the Global Quality Standard for the treatment of severe asthma

Category Statement summary Rationale

Organization

of services

Health care systems should facilitate effective

communication between clinicians and patients to

reduce disease burden and risk of OCS adverse

events

Patients with severe asthma seek care in various

settings, and communication is critical to effective

treatment planning and decision-making

Identification

and referral

Early identification and specialty referral for patients

with severe or treatment-resistant asthma is

critical

Severe asthma is often refractory to usual standards

of care and warrants specialty referral to facilitate

improved outcomes

Management Phenotype assessment of patients with severe asthma

allows for precision-medicine-based care and the

possibility of improved outcomes

Asthma is a heterogenous disease, and

understanding key biomarkers may optimize

decision-making and outcomes

Patient-

centric care

Shared decision-making is key, and outcomes should

be monitored and documented via a personalized

asthma action plan

Shared decision-making and ongoing assessment of

treatment benefit with a multidisciplinary team

are critical for optimizing clinical outcomes

OCS oral corticosteroids

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Criterion 1D: When a suspected case of severeasthma is identified, the patient is evaluated bya multidisciplinary team (MDT) that canexclude or manage other pathology and providetreatment recommendations for ‘‘whole-pa-tient’’ care.

Potential Metrics

(a) Number of facilities with an MDT availablefor assessment and management ofpatients with asthma.

(b) Percentage of facilities with an establishedprotocol for utilizing an MDT for manag-ing patients with asthma.

(c) Percentage of patients with a documentedasthma action plan developed with anMDT.

Local Adaptation Opportunities An MDTmay include specialties such as respiratoryphysicians, clinical nurse specialists, radiolo-gists, pathologists, allergists, physiotherapists,clinical health psychologists, speech and lan-guage therapists, dietitians, and clinicalpharmacists.

Criterion 1E: Health care providers involvedin the care of patients with severe asthmareceive updates on the diagnosis, treatmentplan, and follow-up plan for these patients.

Potential Metrics

(a) Percentage of providers (general practition-ers and specialists) in an MDT receiving anupdate following a significant change in apatient’s status.

(b) Percentage of general practitioners receiv-ing information related to formal patientdiagnosis, relevant investigations under-taken, and treatment plan from the asthmaspecialist (for initial and subsequent visits,ideally within 2 weeks of the specialtyclinic visit).

Local Adaptation Opportunities

(a) Standardize the format of formal diagnosisnotification and/or alert.

(b) Health care communities may wish torecommend suggested procedures for eval-uating and treating patients with asthma(e.g., recommended tests or investigations,recommended treatment plan structure),and document when data (e.g., images orfiles) are provided to the patient.

Element 2: Identification and Referralof Suspected Severe Asthma

Quality Statement 2People with difficult asthma who are unre-sponsive to optimal standard-of-care therapyare rapidly identified, reviewed, and referred tospecialist care.

RationalePeople with diagnosed or suspected severeasthma may not respond to optimal treatmentwith (inhaled) standard-of-care therapies. Thelack of response may be due to poor/suboptimaladherence or insufficient inhaler technique;however, some patients may continue to havesevere uncontrolled asthma despite optimizedmedical management. Regardless of the reason,referral to specialist care is appropriate.

Essential Criteria, Quality Metrics, and LocalAdaptation OpportunitiesCriterion 2A: Patients with suspected severeasthma are referred to an asthma specialist forassessment (utilizing the established referralnetwork; see criterion 1A, above).

Quality Metrics

(a) Percentage of individuals with uncon-trolled asthma on locally agreed or GINAstandard of care (stage 4?).

(b) Percentage of patients with suspected sev-ere asthma referred for diagnosis within aprespecified period of time (e.g., a numberof months defined locally based on abili-ties and perspectives of the country/region).

(c) Percentage of patients with suspected sev-ere asthma in the general population who

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have not been referred to an asthmaspecialist.

(d) Percentage of patients with asthma inprimary care for a prespecified period oftime before referral to specialty asthmacare (e.g., a number of weeks definedlocally based on abilities and perspectivesof the country/region).

(e) Percentage of patients with asthma receiv-ing two or more courses of OCS withoutbeing managed in a specialty care service.

(f) Percentage of patients with asthma receiv-ing three or more SABA in a 12-monthperiod.

Local Adaptation Opportunities

(a) Generate a list of care settings that canrefer to specialty care (e.g., general practice,secondary care, emergency department,community, urgent care), and implementa system to facilitate timely referral.

(b) Provide education about the role of patientself-referral for specialty asthma care.

(c) Establish local criteria for identification ofsuspected severe asthma.

(d) Establish local guidelines on markers ofasthma control, including thresholds forOCS usage and SABA prescribing patternsthat should trigger specialty referral.

(e) Establish local triggers for specialty referral(e.g., maximum threshold of OCS use,number of emergency department orurgent care visits within a defined timeframe).

(f) Establish waiting time targets and thresh-olds for maximum time a patient withuncontrolled asthma should be managedin primary care.

(g) Availability of established guidelines tosupport clinicians with tapering strategiesfor corticosteroids, and exemptions.

Criterion 2B: Local leadership establishes a listof clinical assessment and investigation tools todisseminate to clinicians to improve identifica-tion of severe asthma, and implement whensevere asthma is suspected.

Quality Metrics Percentage of patients withsuspected severe asthma with documentedcompletion of locally agreed upon clinicalassessments/investigations within a prespecifiedperiod of time (e.g., a number of weeks definedlocally based on abilities and perspectives of thecountry/region).

Local Adaptation Opportunities Generate astandardized list of clinical assessment andinvestigation tools and disseminate to clini-cians/clinics for reference and implementationin practice.

Criterion 2C: Clinics/facilities have an asthma‘‘champion’’ who is a peer leader/cliniciantrained in asthma assessment and managementand receives ongoing support from the facilityto serve in the role of change agent. The asthmachampion is responsible to ensure asthma carestandards are maintained, including availabilityand use of recommended tests and procedures,and continuing medical education (CME) isprovided for all clinical staff treating patientswith asthma.

Quality Metrics

(a) Percentage of health care providers withlocal access to an asthma champion intheir facility/clinic.

(b) Percentage of clinical staff by practice type/discipline receiving asthma-specific CMEcredits in a 12-month period.

Local Adaptation Opportunities

(a) Clarify scope of staff members and organi-zational involvement to support mainte-nance of standards and achievement ofcontinuing education guidelines.

(b) Standardize CME content and format.(c) Pursue accreditation for training curricu-

lum to allow provision of formal CMEcredits to incentivize providers to completetraining.

(d) Establish a timeline for CME refreshercourses.

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Element 3: Management of Severe Asthma

Quality Statement 3People with suspected severe asthma referred tospecialists or other trained health care profes-sionals will undergo a phenotype assessment tooptimize asthma medications and promoteprecision-medicine-based care, thus increasingthe chances of improving clinical outcomes.

RationaleThe underlying biologic drivers of severeasthma vary by patient, and are paramount toidentification of severe asthma phenotypes.Understanding the biologic drivers of disease,and the key biomarkers that may better predicta patient’s response to an individual therapy, iscritical to optimize patient care and deliversuperior clinical outcomes.

Essential Criteria, Quality Metrics, and LocalAdaptation OpportunitiesCriterion 3A: Individuals with severe asthmareceive assessment for personalized phenotype-based treatment.

Quality Metrics

(a) Percentage of patients receiving biomarkertests.

(b) Percentage of health care providers withaccess to and who are utilizing toolsrequired 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 phenotypeassessment, which should include, at aminimum, the tools/tests listed above.

Local Adaptation Opportunities

(a) Optimize the type of clinicians involved inassessment planning and interpretation.

(b) Standardize time to phenotype assessment.(c) Centralize testing location.

Criterion 3B: Maintenance OCS should beconsidered an option of last resort, reservedonly for patients who are ineligible for, or donot have access to (e.g., because of location,cost, or insurance coverage) biologic therapies.

Quality Metrics

(a) Percentage of patients receiving, or initi-ated on, maintenance OCS.

(b) Percentage of patients on maintenanceOCS who have documented evidence ofadherence to inhaled medications.

(c) Percentage of patients on maintenanceOCS who are prescribed and take OCS-sparing agents.

Local Adaptation Opportunities

(a) Establish local guidelines and tools to limituse of maintenance OCS.

(b) Establish local guidelines and tools to limituse of OCS in patients with newly identi-fied asthma.

(c) Evaluate the total number of patients onmaintenance OCS (e.g., via an annualreport).

Criterion 3C: For patients currently takingOCS, the asthma action plan will includedevelopment of a corticosteroid-sparingstrategy.

Quality Metrics

(a) Percentage of asthma action plans thatinclude reference to OCS-sparing strategies.

(b) Percentage of patients with reduced use ofOCS (within a 12-month cycle).

(c) Percentage of patients prescribed biologicsfor asthma maintenance care.

Local Adaptation Opportunities

(a) Develop local approaches and tools tosupport standard inclusion of OCS-sparingstrategies as a standard in every asthmaaction plan.

(b) Develop and disseminate exemption crite-ria as guidance for network providers.

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Element 4: Patient-Centric Care

Quality Statement 4Treatment decisions are made in partnershipbetween the patient and clinician, and reflectthe patient’s expectations, priorities, and val-ues. The impact of treatment is regularlyreviewed and tracked in a personalized asthmaaction plan.

RationaleThe goals of management of severe asthma areto reduce the risk of severe exacerbations andimprove daily symptom control. Clinicians arereminded of the need to treat the person, notthe diagnosis, with consideration of comorbidconditions and psychosocial factors. With theincreased number of ‘‘informed patients,’’shared decision-making is more likely to lead tobetter clinical outcomes.

As severe asthma is a chronic, variable con-dition, periodic reviews are reasonable to assesswhether the condition has changed, to considerif alternative intervention is appropriate, and tooffer ongoing education, training, and support.Like most chronic conditions, asthma is asso-ciated with various physical and psychosocialsequelae and comorbidities. Tracking and doc-umenting comprehensive changes as part of adedicated asthma action plan ensures that allproviders involved in the care of a patient withsevere asthma can offer the most informed care.

Essential Criteria, Quality Metrics, and LocalAdaptation OpportunitiesCriterion 4A: Patients with severe asthma receiverelevant information and education sufficientto support participation in shared decision-making.

Quality Metrics

(a) Percentage of severe asthma patientsoffered personalized information relatedto their types of severe asthma at the timeof their formal diagnoses, and at follow-upvisits.

(b) Evaluate perceived value (to patients) ofproviding personalized information aboutasthma during clinic visits.

(c) Percentage of clinical staff with up-to-dateeducation and training to support shareddecision-making.

Local Adaptation Opportunities

(a) Standardize the format and provision ofpatient information. For example:

i. If education is to be provided in aformal educational program/lecture,standardize content, recruitment, andstaff delivering materials to patientsand families.

ii. If education is provided during infor-mal personalized clinical conversationswith a health care provider, standard-ize the information to be provided/reviewed.

iii. If handouts or leaflets are used, ensurethe printed information is updatedwith the most recent best practice dataand is appropriate for the populationserved (e.g., appropriate reading level,language, alternative formats for per-sons with unique learning challengesor disabilities).

iv. Standardize the scope of informationincluded in patient education materi-als according to consensus amongexperts in severe asthma networks,while ensuring adapted, translated,and culturally appropriate versionsare available for diverse populationsin a format personalized for eachpatient/family.

Criterion 4B: Patients with severe asthmareceive a periodic review of their condition andthe impact of management approaches onoutcomes.

Quality Metrics

(a) Percentage of patients receiving periodicfollow-up for their asthma.

(b) Percentage of patients attending asthmareview appointments with an asthmaspecialist.

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(c) Percentage of asthma reviews that includean assessment of psychosocial issues andfunction, in addition to comorbidities.

(d) Additional agreed upon parameters forreview (e.g., level of symptom control, EDvisits, hospital admissions, lung function,inhaler technique review, frequency of useof preventer and reliever medications) thatare documented in the patient medicalrecord.

Local Adaptation Opportunities

(a) Establish protocols to standardize the reg-ularity of periodic review with patients.

(b) Establish protocols to standardize an expli-cit process of managing patients who failto attend specialist asthma review visits.

(c) Establish local protocols for inclusion ofpsychosocial issues in periodic review withpatients.

Criterion 4C: Criteria for a periodic reviewwill be established by local clinical leadership,and published for easy access and use by localclinical providers (i.e., ‘‘A periodic reviewshould include…’’ with criteria to be explicitlydocumented by the local leadership).

Quality Metrics Percentage of locally agreedreview criteria conducted/completed in thespecified time frame.

Local Adaptation Opportunities Criteria con-stituting a periodic review may include:

i. Measurement of asthma and/or symptomcontrol.

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 dedicatedasthma action plan in which changes anddecisions related to their asthma care are inte-grated and well documented.

Quality Metrics Percentage of patients with apersonalized asthma action plan reflective ofcare needs, including personalized contact withhealth care professionals for advice, counsel,and shared decision-making opportunities.

Local Adaptation Opportunities

(a) Establish criteria to standardize asthmaaction plan format and content.

(b) Establish criteria for updating the asthmaaction plan.

Criterion 4E: Patient records are owned by thepatient and available to health care profession-als involved in the patient’s care.

Quality Metrics

(a) Percentage of organizations involved incare of patients with severe asthma thatare able to access patient medical records,including the asthma action plan.

(b) Percentage of patients with access to, or inpossession of, their own medical records.

(c) Percentage of patients sharing their medi-cal record data with members of the MDT.

Local Adaptation Opportunities Expand thescope of accessibility of patient data sharing.

i. Health care professionals in the MDT shouldbe able to easily access relevant medicalinformation for their patient with severeasthma. Reducing barriers to access allowsfor greater personalization of the health careexperience. However, access history isauditable to ensure protection of patientprivacy.

ii. Patients should have easy access to theirmedical records, preferably available in aneasily understandable format. Patientsshould be given the opportunity to discussdata contained in the medical record with aprofessional who can assist them in inter-preting and understanding information,

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particularly in cases in which learning,reading, or cognitive capacity may belimited.

DISCUSSION

Severe asthma is a substantial source of mor-bidity, mortality, and disease burden across theworld. Despite an extensive evidence base andother published clinical guidelines focused onthe management of severe asthma [9], patientsmay not receive GDMT and therapeutic goalsare not reached. In severe asthma, currenttreatment practices include a continued over-reliance on OCS, and underuse of therapies thatcan prevent, or substantially reduce, the fre-quency of exacerbations and associated cost andreduction in HRQOL. Moreover, an accuratediagnosis followed by precision-medicine-basedassessment practices that could support treat-ment personalization and optimization.

Health care providers need education tobetter understand severe asthma, and clinicalguidelines on the assessment and treatment ofthe condition. In addition, improving thetreatment landscape requires systems-levelchanges to enhance awareness of (and access to)specialty referral options and strategies toreduce communication barriers betweenproviders/clinical teams within health care sys-tems. These may include increased access to,and use of, new technologies such as telemon-itoring and digital reporting of treatment usepatterns from electronic inhalers, which mayhelp delay progression to severe asthma[15, 16]. Until such improvements are made,patients will continue to experience more fre-quent asthma exacerbations, emergency carevisits, hospital admissions, and the sequelae ofpsychological, social, and occupational impair-ments commonly associated with a poorlycontrolled, chronic illness.

The PRECISION Steering Committee con-vened to address the urgent need for review ofthe current asthma care landscape, and supportimprovements in standardization of care andaccess to GDMT for severe asthma. The PRECI-SION-supported Charter to Improve Patient Care

in Severe Asthma [13], which outlined six coreprinciples to educate and mobilize key stake-holders, was an important first step to improveawareness of and access to quality care for sev-ere asthma.

The Global Quality Standard outlined in thisreport, which is based on the vast body ofpublished evidence available for asthma careand published clinical guidelines, was the keyproduct produced by the Task Force endeavors.The proposed standard emphasizes core ele-ments (see Table 1) that are reflective of thepatients’ expectations, priorities, and values. Itis aimed at optimizing clinical care and out-comes for all patients with severe asthma andreducing associated cost and burden (at thelevel of the individual, society, and health caresystem).

Governments, payer policymakers, guidelinewriters, clinicians, patients, and caregivers mustunite and mobilize to achieve meaningfulimprovements in severe asthma care. The con-tinuum of care detailed herein is relevant tolocal, regional, national, and global health caresystems and partners, and successful imple-mentation will rely upon thoughtful adaptationbased on the local needs, strengths, and weak-nesses of a clinical system. These standards canbe adapted to meet the needs of any local healthcare system regardless of available resources,communication/medical record access, referralnetwork organization, or knowledge and use ofGDMT. For optimal success, standards must betailored to local requirements, and an imple-mentation plan should be agreed upon by localleaders. Moreover, progress (e.g., processimplementation, outcomes, and uptake) mustbe determined locally, with the goal to comparebetween health care systems to support con-tinual development and improvement neces-sary to optimize patient care and outcomes. Weurge policymakers, health care providers, andpatient advocacy groups to employ the QualityStandard set forth in this document, in additionto the core principles outlined in the comple-mentary PRECISION-supported Charter toImprove Patient Care in Severe Asthma [13]. Theseresources will help achieve consensus on thedefinition of quality care in severe asthma,promote patient-centric care, identify gaps in

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care and areas for improvement, and systemat-ically implement quality care improvementmeasures to improve outcomes and reduce theburden of illness in patients with severe asthma.

CONCLUSIONS

This Quality Standard for severe asthmadetailed by the Improve Access to Better CareTask Force of the PRECISION Steering Com-mittee is well supported by published clinicalguidelines, and serves as a complement to the2018 PRECISION-supported Charter to ImprovePatient Care in Severe Asthma. Key stakeholders(e.g., governments, policymakers, clinicians,payers, patient advocacy groups) are encour-aged to use this Quality Standard to guideimportant collaborative efforts needed to stan-dardize clinical care and optimize outcomes forpatients with severe asthma around the world.

ACKNOWLEDGEMENTS

The authors thank the PRECISION GlobalSteering Committee and the PRECISIONImprove Access to Better Care Task Force. ThePRECISION program is an AstraZeneca-spon-sored global initiative to help people living withsevere asthma have access to appropriate treat-ment and care. PRECISION Improve Access toBetter Care Task Force members: Hannah Saul1,Tonya Winders2, Giorgio Walter Canonica3,Pascal Chanez4, Janwillem Kocks5, JohnHaughney6, Steve Holmes7, Adel Mansur8,Andrew Menzies-Gow9, Yuji Tohda10, CynthiaHallensleben11, Grainne d’Ancona12, Sam Prig-more13, Esther Metting14. 1AstraZeneca, Cam-bridge, UK; 2Allergy & Asthma Network,Vienna, VA, USA; 3Humanitas University, Raz-zano, Italy; 4Aix Marseille Universite, Cliniquedes bronches, allergie et sommeil/ APHM, Mar-seille C2VN Center INSERM INRA UMR1062,Marseille, France; 5University of Groningen,Groningen, Netherlands; 6Glasgow ClinicalResearch Facility, Queen Elizabeth UniversityHospital, Institute of Neurological Sciences,Glasgow, UK; 7Park Medical Practice, SheptonMallet, UK; 8Heartlands Hospital, Birmingham,

UK; 9Royal Brompton and Harefield NHSFoundation Trust, London, UK; 10KindaiUniversity, Osaka, Japan; 11Leiden UniversityMedical Center, Leiden, Netherlands; 12Guysand St. Thomas’ NHS Foundation Trust, Lon-don, UK; 13St. George’s Hospital NHS Founda-tion Trust, London, UK; 14Groningen ResearchInstitute, Groningen, Netherlands.

Funding. AstraZeneca (Gaithersburg, MD,USA) funded this study and the journal’s RapidService Fee and Open Access publication. Allauthors had full access to the content and takecomplete responsibility for its integrity andaccuracy.

Medical Writing, Editorial, and OtherAssistance. Editorial and writing support,including preparation of the draft manuscriptunder the direction and guidance of theauthors, incorporation of author feedback, andmanuscript submission, was provided by TeresaE. Fecteau, PhD (CiTRUS Health Group, Cleve-land, OH, USA), and Michael A. Nissen, ELS(AstraZeneca, Gaithersburg, MD, USA). Thissupport was funded by AstraZeneca.

Authorship. All named authors meet theInternational Committee of Medical JournalEditors criteria for authorship for this article,take responsibility for the integrity of the workas a whole, and have given their approval forthis version to be published.

Disclosures. John Haughney has consul-tancy agreements with AstraZeneca for thePRECISION program, and has received consult-ing fees from AstraZeneca for past work regard-ing management of chronic obstructivepulmonary disease in the UK. Tonya A. Windershas consultancy agreements with AstraZenecafor the PRECISION program. Steve Holmes hasreceived funding from AstraZeneca, Beximco,Boehringer Ingelheim, Chiesi, GlaxoSmithK-line, Johnson and Johnson, Mylan, Napp,Novartis, Nutricia, Orion, Pfizer, Sandoz, Teva,and Trudell Medical International. Pascal Cha-nez has consultancy agreements with AstraZe-neca for the PRECISION program, and hasreceived research and consulting funding from

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AstraZeneca, Amirall, Boehringer Ingelheim,Centocor, GlaxoSmithKline, Merck Sharp &Dohme, Novartis, Teva, Chiesi, and ScheringPlough. Hannah Saul is employed by AstraZe-neca as Global Director of Advocacy and Policy,Respiratory and INA. Andrew Menzies-Gow hasconsultancy agreements with AstraZeneca,Sanofi and Vectura; was an advisory boardmember for AstraZeneca, Sanofi, GlaxoSmithK-line, Novartis, and Teva; received speaker feesfrom AstraZeneca, Sanofi, Novartis and Teva;has received clinical funding from AstraZeneca;and has attended international conferencessponsored by Teva.

Compliance with Ethics Guidelines. Thisarticle is based on Task Force consensus anddoes not contain any studies with human par-ticipants or animals performed by any of theauthors.

Data Availability. Data sharing is notapplicable to this article as no datasets weregenerated or analyzed during the current study.

Open Access. This article is licensed under aCreative Commons Attribution-Non-Commercial 4.0 International License, whichpermits any non-commercial use, sharing,adaptation, distribution and reproduction inany medium or format, as long as you giveappropriate credit to the original author(s) andthe source, provide a link to the CreativeCommons licence, and indicate if changes weremade. The images or other third party materialin this article are included in the article’sCreative Commons licence, unless indicatedotherwise in a credit line to the material. Ifmaterial is not included in the article’s CreativeCommons licence and your intended use is notpermitted by statutory regulation or exceeds thepermitted use, you will need to obtain permis-sion directly from the copyright holder. To viewa copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

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