https://orcid.org/0000-0003-1699-5471
Abstract
Introduction
Little is known about the variability in chronic obstructive pulmonary disease (COPD) management and how it may be affected by patient characteristics across different healthcare systems in the US. This study aims to describe demographic and clinical characteristics of people with COPD and compare management across five primary care medical groups in the US.
Methods
This is a retrospective observational registry study utilizing electronic health records stored in the Advancing the Patient Experience (APEX) COPD registry. The APEX registry contains data from five US healthcare organizations located in Texas, Ohio, Colorado, New York, and North Carolina. Data on demographic and clinical characteristics of primary care patients with COPD between December 2019 and January 2020 were extracted and compared.
Results
A total of 17,192 patients with COPD were included in analysis: Texas (n = 811), Ohio (n = 8722), Colorado (n = 472), New York (n = 1149) and North Carolina (n = 6038). The majority of patients at each location were female (>54%) and overweight/obese (>60%). Inter-location variabilities were noted in terms of age, race/ethnicity, exacerbation frequency, treatment pattern, and prevalence of comorbid conditions. Patients from the Colorado site experienced the lowest number of exacerbations per year while those from the New York site reported the highest number. Hypertension was the most common co-morbidity at 4 of 5 sites with the highest prevalence in New York. Depression was the most common co-morbidity in Ohio. Treatment patterns also varied by site; Colorado had the highest proportion of patients not on any treatment. ICS/LABA was the most commonly prescribed treatment except in Ohio, where ICS/LABA/LAMA was most common.
Conclusions and Relevance
Our data show heterogeneity in demographic, clinical, and treatment characteristics of patients diagnosed with COPD who are managed in primary care across different healthcare organizations in the US.
Abbreviations
AATD, Alpha-1 anti-trypsin deficiency; APEX, advancing the patient experience; CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; EHR, electronic health record; GOLD: Global Initiative for Chronic Obstructive Lung Disease; GERD, gastroesophageal reflux disease; ICS, inhaled corticosteroids; LABA, long-acting beta-agonist; LAMA, long-acting muscarinic antagonist; LRTI, lower respiratory tract infection; MMRC, Modified Medical Research Council; OSA, obstructive sleep apnoea; OCS, oral corticosteroid; PRIO, patient reported information/outcomes; SABA, short-acting beta-agonist; SAMA, short-acting muscarinic antagonist; SD, standard deviation.
Data Sharing Statement
The dataset supporting the conclusions of this article was derived from the APEX COPD Registry. Anonymized Data Ethics Protocols and Transparency committee (ADEPT0520), the American Academy of Family Physicians and the APEX Steering Committee. Central ethics (Institutional Review Board, IRB) approval was obtained from the American Academy of Family Physicians for most sites (AAFP; IRB reference number: 19-349). The authors do not have permission to give public access to the study dataset; researchers may request access to APEX Registry data for their own purposes via the APEX COPD website (https://www.apexcopd.org/) or via the enquiries email [email protected].
Ethics Approval
Patient EHR data were shared in accordance with the local regulatory/ethics requirements. Informed consent was obtained from patients via an online portal to allow data sharing for ethically approved research purposes as well as recruitment for future studies. Patients were permitted to opt out of data sharing. This study was designed, implemented, and reported in accordance with the European Network Centres for Pharmacoepidemiology and Pharmacovigilance (study reference number: EUPAS29401); http://www.encepp.eu/encepp/viewResource.htm?id=29348 and performed in compliance with all applicable local laws and regulations. Governance was provided by Optimum Patient Care (OPC) Global, the Respiratory Effectiveness Group, the Anonymized Data Ethics Protocols and Transparency Committee (ADEPT0520), the American Academy of Family Physicians, and the APEX Steering Committee. Central ethics (Institutional Review Board, IRB) approval was obtained from the American Academy of Family Physicians for most sites (AAFP; IRB reference number: 19-349). Secondary ethics approval was obtained for 1 site which has their own ethics approval board.
Acknowledgments
Medical writing support was provided by Dr. Antony Hardjojo of Jaya Medical Writing Pte Ltd, Singapore. Writing, editorial support, and/or formatting assistance in the development of this manuscript was provided by Andrea Teh, BSc (Hons) and Shilpa Suresh, MSc of the Observational and Pragmatic Research Institute, Singapore. We wish to acknowledge Kidane Gebremariam for his contribution to protocol development. BIPI was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.
Author Contributions
The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors. All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis, and interpretation, or in all these areas. All authors took part in drafting, revising or critically reviewing the article. All authors gave final approval of the version to be published. All authors have agreed on the journal to which the article has been submitted and agree to be accountable for all aspects of the work. All authors have given approval for the submission of this article. The authors received no direct compensation related to the development of the manuscript.
Disclosure
Chester Fox declares no conflict of interest. Wilson Pace is on the advisory board for Mylan; stock from Eli Lilly, Novo Nordisk, Pfizer, Novartis, Johnson & Johnson, Stryker, Amgen, Gilead, and Sanofi.
Elias Brandt, Gabriela Gaona, and Rachel Kent are employees of the DARTNet Institute. Amanda Ratigan is a consultant to Boehringer-Ingelheim, but at the time of this disclosure had received no funding directly or through any organization she works for from Boehringer-Ingelheim.
Victoria Carter, Alexander Evans, Maja Kruszyk, Chantal Le Lievre, and Brooklyn Stanley are employees of Optimum Patient Care, a co-founder of the APEX COPD initiative.
Chelsea Edwards was an employee of Optimum Patient Care Australia at the time that this study was conducted.
Ku-Lang Chang declares no conflict of interest.
MeiLan K Han reports personal fees from GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim, Cipla, Chiesi, Novartis, Pulmonx, Teva, Verona, Merck, Mylan, Sanofi, DevPro, Aerogen, Polarian, Regeneron, United Therapeutics, UpToDate, Altesa Biopharma, Medscape and Integrity. She has received either in kind research support or funds paid to the institution from the NIH, Novartis, Sunovion, Nuvaira, Sanofi, AstraZeneca, Boehringer Ingelheim, Gala Therapeutics, Biodesix, the COPD Foundation and the American Lung Association. She has participated in Data Safety Monitoring Boards for Novartis and Medtronic with funds paid to the institution. She has received stock options from Meissa Vaccines and Altesa Biopharma.
Alan Kaplan is a member of the advisory board of, or speakers bureau for, AstraZeneca, Behring, Boehringer Ingelheim, Covis, Cipla, Grifols, GlaxoSmithKline, Merck Frosst, Novo Nordisk, Novartis, Pfizer, Purdue, Sanofi, Teva, and Trudel.
Janwillem Kocks reports grants, personal fees and non-financial support from AstraZeneca, grants, personal fees and non-financial support from Boehringer Ingelheim, grants and personal fees from Chiesi Pharmaceuticals, grants, personal fees and non-financial support from GSK, grants and non-financial support from Mundi Pharma, grants and personal fees from TEVA, grants and personal fees from Novartis, personal fees from MSD, personal fees from COVIS Pharma, grants from Valneva outside the submitted work; and Janwillem Kocks holds <5% shares of Lothar Medtec GmbH and 72.5% of shares in the General Practitioners Research Institute.
Tessa Li Voti was an employee of Optimum Patient Care at the time this study was conducted.
Cathy Mahle and Asif Shaikh are employees of Boehringer Ingelheim, a co-founder of the APEX COPD initiative.
Barry Make reports funding from the NHLBI for the COPDGene study; grants and medical advisory boards from Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, and Sunovion; personal fees for DSMB from Spiration and Shire/Baxalta; CME personal fees from WebMD, National Jewish Health, American College of Chest Physicians, Projects in Knowledge, Hybrid Communications, SPIRE Learning, Ultimate Medical Academy, Catamount Medical, Eastern Pulmonary Society, Catamount Medical Communications Medscape, Eastern VA Medical Center, Academy Continued Healthcare Learning, and Mt. Sinai Medical Center; royalites from Up-To-Date; medical advisory boards from Novartis, Phillips, Third Pole, Science 24/7, and Verona; grants from Pearl; outside the submitted work.
Neil Skolnik is on advisory boards for AstraZeneca, Teva, Lilly, Boehringer Ingelheim, Sanofi, Janssen Pharmaceuticals, Intarcia, Mylan, and GlaxoSmithKline; Payment for lectures/speaking engagements from AstraZeneca and Boehringer Ingelheim; Research Support from Sanofi, AstraZeneca, Boehringer Ingelheim, and GlaxoSmithKline.
Barbara P Yawn has served on COPD-related advisory boards for GlaxoSmithKline, AstraZeneca, Novartis, and Boehringer Ingelheim, Teva, receives consultancy fees from ndd Medical Technology and received COPD-related investigator-initiated research funds from GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, and Novartis.
David Price has advisory board membership with AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Thermo Fisher; consultancy agreements with Airway Vista Secretariat, AstraZeneca, Boehringer Ingelheim, Chiesi, EPG Communication Holdings Ltd, FIECON Ltd, Fieldwork International, GlaxoSmithKline, Mylan, Mundipharma, Novartis, OM Pharma SA, PeerVoice, Phadia AB, Spirosure Inc, Strategic North Limited, Synapse Research Management Partners S.L., Talos Health Solutions, Theravance and WebMD Global LLC; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Theravance, British Lung Foundation, and UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals and Sanofi Genzyme; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, Thermo Fisher; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 92.61% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp which develops adherence monitoring technology; is peer reviewer for grant committees of the UK Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline.