CONQUEST Quality Standards: For the Collaboration on Quality Improvement Initiative for Achieving Excellence in Standards of COPD Care

Figures & data

Table 1 Lexicon of CONQUEST Key Terms

Term	Definition
CONQUEST Quality Improvement Program	Full name: Collaboration on a Quality Improvement Initiative to Achieve Excellence in Standards of COPD Care. The purpose of the CONQUEST program is to improve the prompt identification of patients with modifiable high-risk COPD, and to support the adoption of guideline-led clinical decision-making for all COPD patients, with a focus on assessment, therapy, and follow-up of patients with modifiable high-risk COPD. The components of the program form the intervention evaluated in PREVAIL.
PREVAIL Studies
PREVAIL Cluster Randomized Controlled Trial	PRagmatic EVAluation of a quality Improvement program for people Living with modifiable high-risk COPD. The impact of the CONQUEST program on COPD outcomes will be evaluated in the subset of patients with modifiable high-risk COPD by a cluster-randomized controlled trial (CRT); self-contained primary care sites (PCS) or general practitioner (GP) practices will be the cluster units of randomization.
Baseline Period	The 24 months prior to randomization where primary care site (PCS) electronic medical record (EMR) data will be retrospectively searched to identify patients meeting modifiable high-risk criteria. The term “trial baseline” is used to describe the end of this 24-month-period, immediately prior to randomization.
Recruitment period	The period over which PCSs are recruited, electronic medical record (EMR) data are extracted, and sites are randomized to the CONQUEST intervention or control arm.
Implementation period	The intervention implementation period (start of the CONQUEST program) follows the recruitment period and runs for 6 months during which time the CONQUEST Quality Standards are implemented in intervention arm PCSs. This includes invitation of modifiable high-risk cohorts for assessment and clinical decision support prompted consultations to initiate optimization of COPD management. Control arm PCS continue with standard care.
Outcome Evaluation Period	Intervention arm site: The outcome evaluation period starts at the end of the 6-month CONQUEST implementation period in the intervention arm. During the outcome evaluation period control arm practices will continue to administer usual care for COPD. Control arm sites: The outcome evaluation period will start 6 months after recruitment of a PCS into the control arm. During the outcome evaluation period control arm practices will continue to administer usual care for COPD. The outcome evaluation period continues until the roll-out of CONQUEST to control arm PCSs.
Roll out	Roll-out of the CONQUEST intervention to the control arm practices commences at the start of the final year (year 5). Control arm roll-out mirrors the intervention arm implementation period; PCSs invite high-risk cohorts of patients for assessment and clinical decision support prompted consultations to initiate optimization of COPD management.
OPC affiliated sites	Those healthcare sites participating in the PREVAIL CRT or implementing the CONQUEST QI Program with the direct support of OPC.
Independent sites	Healthcare systems or sites wishing to implement the CONQUEST QI program (in accordance with the Global QI Operational Protocol) who are not supported by OPC directly. Independent sites will have access to resources and templates related to the program via the Global Operational Protocol and the CONQUEST website.
CONQUEST Target patients
Modifiable “High-risk” patient	Patients with COPD (or potential COPD) who have had 2 or more moderate, or 1 or more severe exacerbations in the last 24 months (with at least one exacerbation occurring in the last 12 months), AND whose medical record data indicates clearly that there is scope for management optimization. Patients with frequent exacerbations are at higher future risk of exacerbations. Frequent exacerbations are linked to accelerated lung function decline, greater risk of cardiovascular events and death. Guidelines state that frequent exacerbators should have their treatment optimized to reduce the risk of future exacerbations and potentially other adverse events. CONQUEST aims to address the management needs of such patients by promoting improved treatment and follow-up.
Undiagnosed patient with potential modifiable high-risk COPD	Patients without a COPD diagnosis who fit the modifiable high-risk criteria with respect to recent exacerbations of potential COPD, and who are smokers or former smokers ≥ 40 years of age. Exclusion: those with an active asthma diagnosis (ie, with an EMR diagnostic code for asthma and evidence of an asthma consultation in the 2 years before randomization (PREVAIL) or before identification (CONQUEST QI program)). N.B. 50 years of age will be used as the cut-off in the CRT in order to increase probability of identifying undiagnosed COPD patients.
Newly diagnosed modifiable high-risk COPD patients	The subset of the above undiagnosed patients who receive a COPD diagnosis following diagnostic assessment in the most recent CONQUEST QIP cycle. OR In the PREVAIL CRT, the subset of the above undiagnosed patients who receive a COPD diagnosis following assessment during the implementation and outcome evaluation period.
Modifiable high-risk COPD diagnosed patients	Patients with a COPD diagnosis at baseline who fit the modifiable high-risk criteria with respect to recent COPD exacerbations and are ≥40 years of age, and in whom there is an opportunity to optimize management.
Patients with scope for management optimization in CONQUEST QI program	The intervention will focus on patients who continue to have exacerbations while on their current therapy (including no therapy SABA, SAMA or SABA/SAMA only) and/or whose management may be optimized by correct diagnosis, or additional non-pharmacological interventions such as smoking cessation interventions or pulmonary rehabilitation.
Exacerbations
COPD exacerbation (EMR database definition)	A significant worsening in respiratory symptoms in people with COPD. Either a moderate exacerbation defined as requiring an acute course of systemic corticosteroids and/or a course of antibiotics within 3 days of a lower respiratory consultation indicative of a probable COPD exacerbation, or an emergency room visit for a COPD-related respiratory cause*; or a severe exacerbation – ie an exacerbation resulting in a hospital admission or death from a COPD-related respiratory cause*.^Citation117 Exacerbations occurring a minimum of 7 days after treatment of the initial exacerbation has ended will be considered as separate exacerbations. Prescribing instructions held in the EMR record will be used to identify the end of an exacerbation (ie, using recorded information on the duration of the treatment).
Exacerbation of potential COPD (EMR database definition)	A significant worsening in respiratory symptoms analogous to a COPD exacerbation in people with suspected but undiagnosed COPD. Either a moderate potential exacerbation defined as requiring an acute course of systemic corticosteroids and/or a course of antibiotics within 3 days of a lower respiratory infection consultation, or an emergency room visit for a potentially COPD-related respiratory cause^†; or a severe exacerbation – ie an exacerbation resulting in a hospital admission or death for a potentially COPD-related respiratory cause^†. Exacerbations occurring a minimum of 7 days after treatment of the initial exacerbation has ended will be considered as separate exacerbations. Prescribing instructions held in the EMR record will be used to identify the end of an exacerbation (ie, using recorded information on the duration of the treatment).
Complicated exacerbation	A severe COPD exacerbation OR A moderate COPD exacerbation involving any of the following: Additional acute course(s) of corticosteroids and/or respiratory antibiotic between 8 and 28 days after the initial event. Further record of moderate/severe COPD exacerbation between 8 and 28 days after the start of the initial event.
Other
Systemic steroid burden	Total annual corticosteroid exposure from oral tablets, intravenous injection, or intramuscular injection measured as the average annual dose of prednisolone taken via any route, in milligrams. Records of systemic steroids other than prednisolone will be converted to prednisolone equivalent doses using USA and UK national formulary conversion tables.^Citation118,Citation119
MACRE Major adverse cardiac or respiratory event	Occurrence of any of the below events: New diagnosis for heart failure, Hospitalization for heart failure, Revascularization, Myocardial Infarction, Stroke, All-cause mortality (further categorized as sudden death, cardiac deaths, respiratory death, none of these), Hospitalization or hospital admittance for respiratory event*, or Complicated exacerbations.
Collation of PRO/PRI questionnaire data	In patients receiving the QIP, PRO/PRI instruments will be completed at least annually, bringing together data received during the implementation of the intervention to be used in annual data analysis and feedback.
Opportunity Analysis	Retrospective study using EMR data to assess the management of patients with modifiable high-risk COPD over time in primary care and describe opportunities for management optimization in line with the Quality Standards. An opportunity analysis will be conducted in both the USA and the UK.

Notes: *Identified using validated code lists for moderate and severe COPD exacerbations. ^†Algorithm developed to define moderate and severe potential COPD exacerbations using appropriate respiratory diagnostic, symptom and investigation codes.

Abbreviations: CONQUEST, COllaboratioN on a QUality improvement initiative to achieve Excellence in STandards of COPD care; COPD, chronic obstructive pulmonary disease; EMR, electronic medical record; CRT, cluster randomized controlled trial; GOLD, Global initiative for chronic Obstructive Lung Disease; GP, general practitioner; ICS, Inhaled Corticosteroids; LABA, long-acting β2-agonist; LAMA, long-acting muscarinic antagonist; MACRE, Major Adverse Cardiac or Respiratory Event; OPC, Optimum Patient Care; PCS, primary care site; PREVAIL; PRagmatic EVAluation of a quality Improvement program for people Living with modifiable high-risk COPD; PRO/PRI, patient-reported outcome/patient-reported information; QIP, Quality Improvement Program; SABA, short-acting β₂-agonist, SAMA, short-acting muscarinic antagonist.

Table 2 Members of the CONQUEST Quality Standard Task Force

Member	Affiliation
Dr Luis Alves (Portugal)	Institute for Biomedical Sciences Abel Salazar, University of Porto, Porto, Portugal
Professor Rongchang Chen (China)	Director of Guangzhou Institute of Respiratory Diseases
Dr Mark Dransfield (USA)	Associate Professor of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine
Professor John Hurst (UK)	Professor of Respiratory Medicine, University College London
Dr Fernando Martinez (USA)	Chief of Division of Pulmonary and Critical Care (GOLD committee)
Dr Marc Miravitlles (Spain)	Pulmonologist, clinical research, Hospital Universitari Vall D’Hebron, Barcelona
Professor Shigeo Muro (Japan)	Professor of Respiratory Medicine, Nara Medical University, Japan
Professor David Price (Singapore)	Observational and Pragmatic Research Institute, Singapore
Dr Anita Sharma (Australia)	GP with cardiovascular interest at Platinum Medical Centre, Chair Scientific Programme Committee IPCRG
Professor Dave Singh (UK)	Professor of Clinical Pharmacology & Respiratory medicine, University of Manchester (GOLD committee)
Tonya Winders (USA)	President and Chief Executive Officer of Allergy & Asthma Network
Hana Müllerová	Medical Evidence Lead for COPD, AstraZeneca
Chris Blango	Employee of AstraZeneca at the time of the manuscript development

Abbreviations: IPCRG, International Primary Care Respiratory Group; GOLD, Global initiative for chronic Obstructive Lung Disease.

Figure 1 CONQUEST quality standards development process.

Abbreviations: BEC, blood eosinophil count; CONQUEST, COllaboratioN on QUality improvement initiative for achieving Excellence in STandards of COPD care; COPD, chronic obstructive pulmonary disease; GOLD, Global initiative for chronic Obstructive Lung Disease; GSC, Global Steering Committee; NICE, National Institute for Health and Clinical Excellence; OPC, optimum patient care; QS, quality standard.

Figure 2 CONQUEST quality standards for the identification and management of patients with COPD at risk of exacerbations or acute respiratory events.

Abbreviations: CONQUEST, COllaboratioN on QUality improvement initiative for achieving Excellence in STandards of COPD care; COPD, chronic obstructive pulmonary disease.

Table 3 COPD Quality Standards and Rationale for Their Inclusion in CONQUEST

Quality Standard	Rationale to Include as a CONQUEST QS
1. Identification	COPD diagnosis is often delayed in primary care.^Citation8,Citation23 Use of a targeted approach on ‘at risk’ patients can help to find these undiagnosed COPD patients.^Citation25,Citation26 COPD remains undertreated, with a gap between guideline recommendations and real world practice.^Citation9,Citation27,Citation28 COPD exacerbations are associated with accelerated lung function decline,^Citation12,Citation32 and increased risk of major adverse CV events,^Citation33^–^Citation36 and worse HRQoL.^Citation37,Citation38 The socio-economic burden of COPD is high.^Citation6,Citation7
2. Assessment of disease and risk quantification	Symptom assessment using mMRC and or CAT score and exacerbation history to inform and guide therapy.^Citation3 BEC is recommended as one marker of steroid responsiveness in stable COPD.^Citation3,Citation25,Citation27 CV disease in COPD patients carries an increased risk of death and hospitalization.^Citation5,Citation56 Other co-morbidities (eg, anxiety/depression, GERD, DM, Osteoporosis) are associated with a higher COPD symptom burden, higher likelihood of exacerbations and reduced therapy compliance.^Citation60
3. Non-pharmacological and pharmacological interventions	CONQUEST recommends:^Citation3 Smoking cessation interventions as necessary. Pulmonary Rehabilitation referrals where indicated. Long-term oxygen therapy where indicated. Dual bronchodilators to all who are symptomatic despite being on single therapy. Triple therapy for appropriate patients with increased exacerbation risk, higher BEC, and potentially to those with greater CV disease risk. Adequate and prompt pharmacological therapy of cardiac risk factors and disease. Appropriate inhaler choice and checking of inhaler technique. Appropriate use of OCS and antibiotics to treat exacerbations. Pneumococcal and annual influenza vaccination to all with COPD and Covid-19 vaccination according to local recommendations.
4. Follow-up	GOLD recommends that current therapy should be recorded and reviewed with up-to-date biomarkers, post-bronchodilator spirometry, symptom severity scores and exacerbation rates.^Citation3 Pulse oximetry used to evaluate the need for supplemental oxygen therapy.^Citation3 Errors in inhaler technique are associated with worse disease outcomes.^Citation96 Smokers with COPD are > twice as likely to quit if they received ‘high-intensity behavioral support’.^Citation98 NICE COPD guidelines recommend calculation of BMI at the time to diagnosis and at follow-up, and referral for dietetic advice is recommended for those with low or high BMI.^Citation20 Patient needs and requirements can change over time, so the role of PR should be part of regular patient follow-up. NICE and GOLD recommend pneumococcal and influenza vaccination to all with COPD.^Citation3,Citation25

Abbreviations: BEC, blood eosinophil count; BMI, body mass index; CONQUEST, COllaboratioN on QUality improvement initiative for achieving Excellence in STandards of COPD care; CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; CV, cardiovascular; DM, diabetes mellitus; GERD, gastroesophageal reflux disease; GOLD, Global initiative for chronic Obstructive Lung Disease; HRQoL, health-related quality of life; mMRC, modified Medical Research Council breathlessness score; NICE, National Institute for Health and Clinical Excellence; OCS, oral corticosteroid; PR, pulmonary rehabilitation.

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