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Objective: Management of chronic obstructive pulmonary disease (COPD) with inhaled corticosteroid/long-acting β 2 -agonist (ICS/LABA) improves lung function and health status and reduces COPD exacerbation risk versus monotherapy. This study described treatment use, healthcare resource utilisation (HCRU), healthcare costs and outcomes following initiation of single-device ICS/LABA as initial maintenance therapy (IMT)., Design: Retrospective cohort study., Setting: Primary care, England., Data Sources: Linked data from the Clinical Practice Research Datalink Aurum and Hospital Episode Statistics datasets., Participants: Patients with COPD and ≥1 single-device ICS/LABA prescription between July 2015 and December 2018 were included., Primary and Secondary Outcome Measures: Treatment pathways, COPD-related HCRU and healthcare costs, COPD exacerbations, time to triple therapy, medication adherence (proportion of days covered ≥80%) and indexed treatment time to discontinuation. Data for patients without prior maintenance therapy history (IMT users) and non-triple users were assessed over a 12-month follow-up period., Results: Of 13 451 new ICS/LABA users, 5162 were IMT users (budesonide/formoterol, n=1056; beclomethasone dipropionate/formoterol, n=2427; other ICS/LABA, n=1679), for whom at 3 and 12 months post-index, 45.6% and 39.4% were still receiving any ICS/LABA. At >6 to ≤12 months, the proportion of IMT users with ≥1 outpatient visit (10.1%) and proportion with ≥1 inpatient stay (12.6%) had increased from those at 3 months (9.0% and 7.4%, respectively). Inpatient stays contributed most to total COPD-related healthcare costs. For non-triple IMT users, at 3 and 12 months post-index, 4.5% and 13.7% had ≥1 moderate-to-severe COPD exacerbation. Time to triple therapy initiation and time to discontinuation of index medication ranged from 45.9 to 50.2 months and 2.3 to 2.8 months between treatments. Adherence was low across all time points (21.5-27.6%). Results were similar across indexed therapies., Conclusions: In the year following treatment initiation, ICS/LABA adherence was poor and many patients discontinued or switched therapies, suggesting that more consideration and optimisation of treatment is required in England for patients initiating single-device ICS/LABA therapy., Competing Interests: Competing interests: AC, GR, CC and AI are employees of GSK and hold stock and shares at GSK. AI is also an unpaid part-time Professor at McMaster University. TT, RWood and RWild are employees of Adelphi Real World, which received funding from GSK to conduct the study, but not for manuscript development. VLB was an employee of Adelphi Real World at the time of the study and is currently an employee of Bayer AG UK, and holds stock and shares in Bayer AG UK. Adelphi Real World is a business that provides consulting and other research services to pharmaceutical, device, government and non-government organisations. Adelphi Real World employees work with a variety of companies and organisations and are expressly prohibited from receiving any payment or honoraria directly from these organisations for services rendered., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To create case definitions for confirmed COVID-19 diagnoses, COVID-19 vaccination status and three separate definitions of high risk of severe COVID-19, as well as to assess whether the implementation of these definitions in a cohort reflected the sociodemographic and clinical characteristics of COVID-19 epidemiology in England., Design: Retrospective cohort study., Setting: Electronic healthcare records from primary care (Clinical Practice Research Datalink, CPRD) linked to secondary care data (Hospital Episode Statistics) data covering 24% of the population in England., Participants: 2 271 072 persons aged 1 year and older diagnosed with COVID-19 in CPRD Aurum between 1 August 2020 and 31 January 2022., Main Outcome Measures: Age, sex and regional distribution of COVID-19 cases and COVID-19 vaccine doses received prior to diagnosis were assessed separately for the cohorts of cases identified in primary care and those hospitalised for COVID-19 (primary diagnosis code of ICD-10 U07.1 'COVID-19'). Smoking status, body mass index and Charlson Comorbidity Index were compared for the two cohorts, as well as for three separate definitions of high risk of severe disease used in the UK (National Health Service Highest Risk, PANORAMIC trial eligibility, UK Health Security Agency Clinical Risk prioritisation for vaccination)., Results: Compared with national estimates, CPRD case estimates under-represented older adults in both the primary care (age 65-84: 6% in CPRD vs 9% nationally) and hospitalised (31% vs 40%) cohorts, and over-represented people living in regions with the highest median wealth areas of England (20% primary care and 20% hospital admitted cases in South East vs 15% nationally). The majority of non-hospitalised cases and all hospitalised cases had not completed primary series vaccination. In primary care, persons meeting high-risk definitions were older, more often smokers, overweight or obese, and had higher Charlson Comorbidity Index score., Conclusions: CPRD primary care data are a robust real-world data source and can be used for some COVID-19 research questions, however, limitations of the data availability should be carefully considered. Included in this publication are supplemental files for a total of over 28 000 codes to define each of three definitions of high risk of severe disease., Competing Interests: Competing interests: KMA, LJM, MR, DM, JLN, CT, DM and JY are employees of Pfizer or Pfizer and may hold Pfizer stock or stock options. KKR and TT are employees of Adelphi Real World which has received consulting fees from Pfizer., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To quantify direct costs and healthcare resource utilisation (HCRU) associated with acute COVID-19 in adults in England., Design: Population-based retrospective cohort study using Clinical Practice Research Datalink Aurum primary care electronic medical records linked to Hospital Episode Statistics secondary care administrative data., Setting: Patients registered to primary care practices in England., Population: 1 706 368 adults with a positive SARS-CoV-2 PCR or antigen test from August 2020 to January 2022 were included; 13 105 within the hospitalised cohort indexed between August 2020 and March 2021, and 1 693 263 within the primary care cohort indexed between August 2020 and January 2022. Patients with a COVID-19-related hospitalisation within 84 days of a positive test were included in the hospitalised cohort., Main Outcome Measures: Primary and secondary care HCRU and associated costs ≤4 weeks following positive COVID-19 test, stratified by age group, risk of severe COVID-19 and immunocompromised status., Results: Among the hospitalised cohort, average length of stay, including critical care stays, was longer in older adults. Median healthcare cost per hospitalisation was higher in those aged 75-84 (£8942) and ≥85 years (£8835) than in those aged <50 years (£7703). While few (6.0%) patients in critical care required mechanical ventilation, its use was higher in older adults (50-74 years: 8.3%; <50 years: 4.3%). HCRU and associated costs were often greater in those at higher risk of severe COVID-19 than in the overall cohort, although minimal differences in HCRU were found across the three different high-risk definitions. Among the primary care cohort, general practitioner or nurse consultations were more frequent among older adults and the immunocompromised., Conclusions: COVID-19-related hospitalisations in older adults, particularly critical care stays, were the primary drivers of high COVID-19 resource use in England. These findings may inform health policy decisions and resource allocation in the prevention and management of COVID-19., Competing Interests: Competing interests: JY, KMA, MR, LJM, CT, TM, KN, DM, Tamuno Alfred, MA and JLN are employees of Pfizer and may hold stock or stock options. KKR, TT, PP, BEB and RW are employees of Adelphi Real World, which received funds from Pfizer to conduct the study and develop the manuscript., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Osteoarthritis (OA) affects 10% of adults in the UK. Despite over one-third of people with OA experiencing chronic pain, few studies have examined the population-level impact of chronic pain associated with OA. We compared resource-use and epidemiological outcomes in patients with mild, moderate and severe chronic OA-associated pain and matched controls without known OA., Design: Retrospective, longitudinal, observational cohort study (July 2008 to June 2019)., Setting: Electronic records extracted from Clinical Practice Research Datalink GOLD primary care linked to Hospital Episode Statistics (HES)., Participants: Patients (cases; n=23 016) aged ≥18 years with chronic OA-associated pain. Controls (n=23 016) without OA or chronic pain matched on age, sex, comorbidity burden, general practitioner practice and available HES data., Interventions: None., Primary and Secondary Outcome Measures: Total healthcare resource use (HCRU), direct healthcare costs in 0-12, 12-24 and 24-36 months postindex. Secondary outcomes included incidence and prevalence of chronic OA-associated pain and pharmacological management., Results: HCRU was consistently greater in cases versus controls for all resource categories during preindex and postindex periods. Across follow-up periods, resource use was greatest in patients with severe pain. In the first 12 months postindexing, mean total costs incurred by cases were four times higher versus matched controls (£256 vs £62); costs were approximately twice as high in cases vs controls for months 12-24 (£166 vs £86) and 24-36 (£150 vs £81; all p<0.0001). The incidence of new cases of chronic pain associated with OA was 2.64 per 1000 person-years; the prevalence was 1.4%., Conclusions: This study highlights the real-world cost of chronic pain associated with OA in cases versus matched controls. We included patients with mild, moderate and severe pain associated with OA, and showed HCRU in discrete 1-year time frames. The true economic burden of pain associated with OA is likely to be considerably higher when indirect costs are considered., Competing Interests: Competing interests: GC, PC and CL are employees of Pfizer UK, which provided funding for this study; HS was an employee of Pfizer UK during the conduct of the work; RW, LM and TT are employees of Adelphi Real World, which received funding from Pfizer and Eli Lilly & Company in connection with the development of this manuscript and who are paid consultants to Pfizer and Eli Lilly & Company; RK declares a personal financial interest in his employment by the University of Nottingham, which receives funding for his salary in part from the Primary Integrated Community Solutions Ltd. In the past 36 months, RK declares consultancy through his employment with the University of Nottingham to Pfizer and Mibe; AJD declares a personal financial interest in his employment with York Medical Group (YMG), and over the past 36 months with NHS111 and RCP (London), from whom he receives payment for his work as a part-time salaried GP with YMG, and over the past 36 months as a GP on the NHS111 COVID 19 Response and the NICE Gout Committee, respectively, and in his ownership and directorship of AD Outcomes. In the past 36 months, AJD declares the following personal financial interests through medical and health economics consultancy work for AD Outcomes for: Emotive (Agency), Grunenthal (UK), Grunenthal, Pfizer (UK), Pharmacy Magazine, Spink Health, Tilray (Portugal) and RCGP, as a racecourse doctor for various racecourses (Croft, Doncaster, Market Rasen, Newcastle, Pontefract, Redcar, Southwell and Thirsk) and as a locum GP with out-of-hours, NHS111 and urgent care work for Vocare part of Totally Plc. AJD has a non-personal financial interest in his roles as a Trustee of the Primary Care Rheumatology & Musculoskeletal Medicine (PCRMM) Society (Trustee from 2017 2020) and as Trustee of the UK Gout Society (ongoing). The PCRMM Society has received funding from multiple companies for its annual conference including from Pfizer (UK) in 2020. AJD's work as a Trustee of PCRMM Society and UK Gout Society and as GP Clinical Lead for the North of England Low Back Pain Group are voluntary and unpaid; DW declares a personal financial interest in his employment by the University of Nottingham, which receives funding for his salary from the UK Government, Sherwood Forest Hospitals NHS Foundation Trust and UKRI. He is Director UKRI/Versus Arthritis Advanced Pain Discovery Platform (personal pecuniary: paid by University of Nottingham as part of job plan, funded by UKRI), Honorary Consultant Rheumatologist at Sherwood Forest Hospitals NHS Foundation Trust (personal pecuniary; paid by University of Nottingham as part of job plan, funded by Sherwood Forest Hospitals) and Professor of Rheumatology, University of Nottingham (personal pecuniary; paid by University of Nottingham). In the past 36 months, DW declares the following non-personal financial interests: research support to the University of Nottingham from Versus Arthritis and National Institute for Health and care Research; grants from Pfizer, Eli Lilly and UCB Pharma; consultancy through his employment with the University of Nottingham to Pfizer, Eli Lilly, AbbVie, AKL R&D, Galapagos, Reckitt Benckiser Health and GlaxoSmithKline Plc, and responsibilities for investigator-led grants outside the work in this presentation held by the University of Nottingham from Pfizer, Lilly and UCB Pharma, and research grants from Versus Arthritis; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events (to University of Nottingham) from Pfizer and AbbVie., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Despite the prevalence of osteoarthritis (OA) in England, few studies have examined the health economic impact of chronic pain associated with OA. The aim of this study was to compare outcomes in patients with moderate-to-severe chronic pain associated with OA and matched controls without known OA., Design: Retrospective, longitudinal, observational cohort study., Setting: Electronic records extracted from the Clinical Practice Research Datalink GOLD primary care database linked to Hospital Episode Statistics (HES) data set., Participants: Patients (cases; n=5931) ≥18 years and with existing diagnosis of OA and moderate-to-severe pain associated with their OA, and controls matched on age, sex, comorbidity burden, general practitioner (GP) practice and availability of HES data., Interventions: None., Primary and Secondary Outcome Measures: Total healthcare resource use (HCRU) and direct healthcare costs during 0-6, 0-12, 0-24 and 0-36 months of follow-up. Secondary outcomes measures included pharmacological management and time to total joint replacement., Results: Patients with moderate-to-severe chronic pain associated with OA used significantly more healthcare services versus matched controls, reflected by higher HCRU and significantly higher direct costs. During the first 12 months' follow-up, cases had significantly more GP consultations, outpatient attendances, emergency department visits and inpatient stays than matched controls (all p<0.0001). Total mean costs incurred by cases during 0-12 months' follow-up were five times higher in cases versus controls (mean (SD): £4199 (£3966) vs £781 (£2073), respectively). Extensive cycling through pharmacological therapies was observed; among cases, 2040 (34.4%), 1340 (22.6%), 841 (14.2%), 459 (7.7%) and 706 (11.9%) received 1-5, 6-10, 11-15, 16-20 and >20 lines of therapy, respectively., Conclusions: This wide-ranging, longitudinal, observational study of real-world primary and secondary care data demonstrates the impact of moderate-to-severe chronic pain associated with OA in patients compared with matched controls. Further studies are required to fully quantify the health economic burden of moderate-to-severe pain associated with OA., Competing Interests: Competing interests: GC and PC are employees of Pfizer UK, which provided funding for this study. CL was an employee of Pfizer UK at the time of the work and is now employed by Pfizer Australia. HS was an employee of Pfizer UK during the conduct of the work. RW and TT are employees of Adelphi Real World, which received funding to conduct this study. RK declares a personal financial interest in his employment by the University of Nottingham, which receives funding for his salary in part from the Primary Integrated Community Solutions. In the past 36 months, RK declares consultancy through his employment with the University of Nottingham to Pfizer and Mibe. AJD declares a personal financial interest in his employment with York Medical Group (YMG), and over the past 36 months with NHS111 and RCP (London), from whom he receives payment for his work as a part-time salaried general practitioner (GP) with YMG, and over the past 36 months as a GP on the NHS111 COVID-19 Response and the NICE Gout Committee, respectively, and in his ownership and directorship of AD Outcomes. In the past 36 months, AJD declares the following personal financial interests through medical and health economics consultancy work for AD Outcomes for: Emotive (Agency), Grunenthal (UK), Grunenthal (GmbH), Pfizer (UK), Pharmacy Magazine, Spink Health, Tilray (Portugal) and RCGP, as a racecourse doctor for various racecourses (Croft, Doncaster, Market Rasen, Newcastle, Pontefract, Redcar, Southwell and Thirsk) and as a locum GP with out-of-hours, NHS111 and urgent care work for Vocare part of Totally. AJD has a non-personal financial interest in his roles as a Trustee of the Primary Care Rheumatology & Musculoskeletal Medicine (PCRMM) Society (Trustee from 2017 to 2020) and as Trustee of the UK Gout Society (ongoing). The PCRMM Society has received funding from multiple companies for its annual conference including from Pfizer (UK) in 2020. AJD’s work as a Trustee of PCRMM Society and UK Gout Society and as GP Clinical Lead for the North of England Low Back Pain Group are voluntary and unpaid. DW declares a personal financial interest in his employment by the University of Nottingham, which receives funding for his salary from the UK Government, Sherwood Forest Hospitals NHS Foundation Trust and UKRI. He is Director UKRI/Versus Arthritis Advanced Pain Discovery Platform (personal pecuniary: paid by University of Nottingham as part of job plan, funded by UKRI), Honorary Consultant Rheumatologist at Sherwood Forest Hospitals NHS Foundation Trust (personal pecuniary; paid by University of Nottingham as part of job plan, funded by Sherwood Forest Hospitals) and Professor of Rheumatology, University of Nottingham (personal pecuniary; paid by University of Nottingham). In the past 36 months DW declares the following non-personal financial interests: research support to the University of Nottingham from Versus Arthritis and National Institute for Health and care Research; grants from Pfizer, Eli Lilly, and UCB Pharma; consultancy through his employment with the University of Nottingham to Pfizer, Eli Lilly, AbbVie, AKL R&D, Galapagos, Reckitt Benckiser Health, and GlaxoSmithKline, and responsibilities for investigator-led grants outside the work in this presentation held by the University of Nottingham from Pfizer, Lilly and UCB Pharma, and research grants from Versus Arthritis; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events (to University of Nottingham) from Pfizer and AbbVie., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)