@article{9871e67567904564864a09d90557ab9b,
title = "Identifying cases of undiagnosed, clinically significant COPD in primary care: Qualitative insight from patients in the target population",
abstract = "Background:Many cases of chronic obstructive pulmonary disease (COPD) are diagnosed only after significant loss of lung function or during exacerbations.Aims:This study is part of a multi-method approach to develop a new screening instrument for identifying undiagnosed, clinically significant COPD in primary care.Methods:Subjects with varied histories of COPD diagnosis, risk factors and history of exacerbations were recruited through five US clinics (four pulmonary, one primary care). Phase I: Eight focus groups and six telephone interviews were conducted to elicit descriptions of risk factors for COPD, recent or historical acute respiratory events, and symptoms to inform the development of candidate items for the new questionnaire. Phase II: A new cohort of subjects participated in cognitive interviews to assess and modify candidate items. Two peak expiratory flow (PEF) devices (electronic, manual) were assessed for use in screening.Results:Of 77 subjects, 50 participated in Phase I and 27 in Phase II. Six themes informed item development: exposure (smoking, second-hand smoke); health history (family history of lung problems, recurrent chest infections); recent history of respiratory events (clinic visits, hospitalisations); symptoms (respiratory, non-respiratory); impact (activity limitations); and attribution (age, obesity). PEF devices were rated easy to use; electronic values were significantly higher than manual (P<0.0001). Revisions were made to the draft items on the basis of cognitive interviews.Conclusions:Forty-eight candidate items are ready for quantitative testing to select the best, smallest set of questions that, together with PEF, can efficiently identify patients in need of diagnostic evaluation for clinically significant COPD.",
author = "Leidy, {Nancy K.} and Katherine Kim and Bacci, {Elizabeth D.} and Yawn, {Barbara P.} and Mannino, {David M.} and Thomashow, {Byron M.} and Barr, {R. Graham} and Rennard, {Stephen I.} and Houfek, {Julia F.} and Han, {Meilan K.} and Meldrum, {Catherine A.} and Make, {Barry J.} and Bowler, {Russ P.} and Steenrod, {Anna W.} and Murray, {Lindsey T.} and Walsh, {John W.} and Fernando Martinez",
note = "Funding Information: Funding for this work was provided by the National Heart, Lung, and Blood Institute NHLBI: R01 HL 114055. Additional support was provided by NHLBI:R01 HL089856 and R01 HL089897. Funding Information: NKL, EDB, KK, AWS and LTM are employees of Evidera, a health care research firm that provides consulting and other research services to pharmaceutical, device, government and non-government organisations. In this salaried position, they work with a variety of companies and organisations and receive no payment or honoraria directly from these organisations for services rendered. BPY has received research funding from NIH, AHRQ, CDC and from BI for research on COPD. BPY has received compensation from Merck and Forrest for COPD advisory boards on COPD, and Grifols for advisory board on Alpha-1 antitrypsin deficiency states. DMM has received honoraria/consulting fees and served on speaker bureaus for GlaxoSmithKline PLC, Novartis Pharmaceuticals, Pfizer Inc., Boehringer-Ingelheim, AstraZeneca PLC, Forest Laboratories Inc., Merck, Amgen and Creative Educational Concepts. Furthermore, he has received royalties from UptoDate and is on the Board of Directors of the COPD Foundation. BMT has consulted for Boehringer-Ingelheim and has been on advisory boards for GlaxoSmithKline PLC, Novartis, AstraZeneca PLC and Forest. RGB received grant support from NIH, US-EPA and the Alpha1 Foundation; he has received royalties from UpToDate. SIR has had or currently has a number of relationships with companies who provide products and/or services relevant to outpatient management of chronic obstructive pulmonary disease, including AARC, American Board of Internal Medicine, Able Associates, Align2 Acton, Almirall, APT, AstraZeneca, American Thoracic Society, Beilenson, Boehringer Ingelheim, Chiesi, CIPLA, Clarus Acuity, CME Incite, COPD Foundation, Cory Paeth, CSA, CSL Behring, CTS Carmel, Dailchi Sankyo, Decision Resources, Dunn Group, Easton Associates, Elevation Pharma, FirstWord, Forest, GLG Research, Gilead, Globe Life Sciences, GlaxoSmithKline, Guidepoint, Health Advance, HealthStar, HSC Medical Education, Johnson and Johnson, Leerink Swan, LEK, McKinsey, Medical Knowledge, Medimmune, Merck, Navigant, Novartis, Nycomed, Osterman, Pearl, PeerVoice, Penn Technology, Pennside, Pfizer, Prescott, Pro Ed Communications, PriMed, Pulmatrix, Quadrant, Regeneron, Saatchi and Saatchi, Sankyo, Schering, Schlesinger Associates, Shaw Science, Strategic North, Summer Street Research, Synapse, Takeda, Telecon SC, ThinkEquity; these relationships include serving as a consultant, advising regarding clinical trials, speaking at continuing medical education programmes and performing funded research both at basic and clinical levels. SIR does not own any stock in any pharmaceutical companies. JFH declares no conflict of interest. MKH has consulted for GSK, Boehringer-Ingelheim and Regeneron. She has served on speaker bureaus for GSK, Novartis, Boehringer-Ingelheim, Forest and Grifols. CAM declares no conflict of interest. BJM has participated in research studies and/or served on medical advisory boards for AstraZeneca, Boehringer-Ingelheim, CSL Bering, GlaxoSmithKline, Forest, Novartis, Spiration and Sunovion. The work of RPB has been funded by the NIH, FAMRI, Butcher Foundation and John W. Carson Foundation. He participates in AstraZeneca-and GSK-sponsored clinical trials. He has received compensation as a member of scientific advisory boards of Boehringer Ingelheim Pharmaceutical. JWW declares no conflict of interest. FM has participated in Steering Committee in COPD or IPF sponsored by Bayer, Centocor, Forest, Gilead, Janssens, GSK, Nycomed/Takeda and Promedior. He has participated in advisory boards for COPD or IPF for Actelion, Amgen, AstraZeneca, Boehringer Ingelheim, Carden Jennings, CSA Medixcal, Ikaria, Forest, Genentech, GSK, Janssens, Merck, Pearl, Nycomed/Takeda, Pfizer, Roche, Sudler & Hennessey, Veracyte and Vertex. He has prepared or presented continuing medical presentations in COPD or IPF for the American College of Chest Physicians, the American Thoracic Society, CME Incite, Center for Health Care Education, Inova Health Systems, MedScape, Miller Medical, National Association for Continuing Education, Paradigm, Peer Voice, Projects in Knowledge, Spectrum Health System, St John{\textquoteright}s Hospital, St Mary{\textquoteright}s Hospital, University of Illinois Chicago, University of Texas Southwestern, University of Virginia, UpToDate and Wayne State University. FM has participated in data safety monitoring committees sponsored by GSK and Stromedix. He has aided with FDA presentations sponsored by Boehringer Ingelheim, GSK and Ikaria. He has spoken on COPD for Bayer, Forest, GSK and Nycomed/Takeda. He has participated in advisory teleconferences sponsored by the American Institute for Research, Axon, Grey Healthcare, Johnson & Johnson and Merion. He has received book royalties from Informa. Publisher Copyright: {\textcopyright} 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited.",
year = "2015",
month = apr,
day = "16",
doi = "10.1038/npjpcrm.2015.24",
language = "English (US)",
volume = "25",
journal = "npj Primary Care Respiratory Medicine",
issn = "2055-1010",
publisher = "Nature Publishing Group",
}