Identifying Cases of Undiagnosed, Clinically Significant COPD in Primary Care Qualitative Insight from Patients in the Target Population

SUPPLEMENTARY INFORMATION Identifying Cases of Undiagnosed, Clinically Significant COPD in Primary Care: Qualitative Insight from Patients in the Target Population NK Leidy, PhD1; K Kim, MPH1; EJ Dansie, PhD1; BP Yawn, MD, MSc2; DM Mannino, MD3; BM Thomashow, MD4; RG Barr, MD4; SI Rennard, MD5; JF Houfek, PhD5; MK Han, MD, MS6; CA Meldrum, PhD6; BJ Make, MD7; RP Bowler, MD7; AW Steenrod, MPH1; LT Murray, MPH1; JW Walsh8; F Martinez, MD, MS9; for the High-Risk-COPD Screening Study Group10 Evidera, Bethesda MD; 2Olmsted Medical Center, Rochester MN; 3University of Kentucky, Lexington KY; 4Columbia University, New York NY; 5University of Nebraska, Omaha NE; University of Michigan, Ann Arbor MI; 7National Jewish Health, Denver CO; 8COPD Foundation, Washington DC; 9Weill Cornell Medical Center, New York, NY 10 High-Risk-COPD Screening Study Group: Rebecca Copeland, BS, University of Kentucky; Tim Dorius, MD, University of Nebraska Medical Center; David Hengerer, BA, Evidera; Patricia Jellen, RN, MSN, New York Presbyterian Hospital; Marge Kurland, RN, Olmsted Medical Center; Karen Malley, BA, Evidera; Jason Shiffermiller, MD, MPH, University of Nebraska Medical Center; Christina Schnell, BA, CCRC, National Jewish Health; Lori Silveira, PhD, MS, National Jewish Health; Sonja Stringer, MPH, Evidera; Deb Sumnick, PBT, University of Nebraska; Randel Plant, COPD Foundation; Jennifer Underwood, CCRP, National Jewish Health; Beth Whippo, MSN, RN-BC, New York Presbyterian Hospital Cognitive Interviews This supplement describes the methods and results of the cognitive interview phase of instrument development The purposes of these interviews are to assess respondent comprehension of the draft instructions and pool of candidate questions for the screener and make adjustments for added clarity before the items are administered to a large sample for quantitative testing and item-reduction METHOD Study Design One-on-one in-person cognitive interviews were conducted with adults with and without COPD Data on value consistency and ease of use of electronic and manual PEF devices were also collected Sample The sample included individuals from the target population, with and without experiences with the constructs assessed in the draft item pool Three sets of individuals were recruited Set included those with a recent COPD diagnosis (prior 36 months) and an FEV1/FVC Ratio 2 Risk Factors (Set 2) (N=9) No COPD No Pre-Screen (Set 3) (N=10) Age, Mean (SD) 60 (10) 64 (9) 59 (11) 58 (10) 17 (63%) (63%) (67%) (60%) (7%) (0%) (0%) (20%) 25 (93%) (100%) (100%) (80%) 18 (67%) (88%) (56%) (60%) Black or African American (2%) (13%) (22%) (30%) Asian (4%) (0%) (11%) (0%) Other (7%) (0%) (11%) (10%) Married 12 (44%) (38%) (44%) (50%) Other (single, divorced, separated, widowed) 15 (56%) (63%) (56%) (50%) Employed 16 (59%) (50%) (67%) (60%) Retired (19%) (25%) (22%) (10%) Disabled (11%) (13%) (0%) (20%) Other (unemployed, homemaker/housewife) (11%) (13%) (11%) (10%) High school or less 13 (48%) (50%) (33%) (60%) Some college, vocational training (26%) (25%) (22%) (30%) College degree or more (26%) (25%) (44%) (10%) Gender, n (%) Male Ethnicity, n (%) Hispanic or Latino Not Hispanic or Latino Racial Background, n (%)1 White Marital Status, n (%) Employment Status, n (%)1 Education Level, n (%) Categories are not mutually exclusive Table Sample Clinical Characteristics Total (N=27) Recent COPD (Set 1) (N=8) No COPD > Risk Factors (Set 2) (N=9) No COPD No Pre-Screen (Set 3) (N=10) Never smoked, n (%) (22%) (0%) (22%) (40%) Smoked cigarettes, n (%) 20 (74%) (88%) (78%) (60%) Former, n (%) 6/20 (30%) 4/7 (57%) 1/7 (14%) 1/6 (17%) Current, n (%) 14/20 (70%) 3/7 (43%) 6/7 (86%) 5/6 (83%) Age started smoking, mean (SD) 16 (4) 16 (3) 17 (5) 15 (3) Duration of smoking (years) 34 (16) 28 (21) 44 (13) 29 (7) Pack-years 29 (25) 25 (25) 41 (32) 19 (9) History of asthma (15%) (38%) (0%) (10%) Exposure (smoke, dust, gas, air) 23 (85%) (88%) (78%) (90%) Colds move to chest 17 (63%) (88%) (56%) (50%) (7%) (25%) (0%) (0%) 12 (44%) (50%) (33%) (50%) (4%) (0%) (11%) (0%) 12 (44%) (75%) (33%) (30%) Cough 12 (44%) (75%) (33%) (30%) Shortness of breath (overall) 19 (70%) (88%) (67%) (60%) With strenuous activity 18 (67%) (88%) (56%) (60%) With light activity (15%) (25%) (11%) (10%) At rest (7%) (13%) (11%) (0%) None 13 (48%) (13%) (67%) (60%) Cold (26%) (38%) (11%) (30%) Chest infection (7%) (25%) (0%) (0%) Pneumonia (0%) (0%) (0%) (0%) (4%) (13%) (0%) (0%) Characteristic Smoking Status and History Other Risk Factors, n (%) Childhood breathing conditions Family history of breathing problems Breathing-Related Symptoms1, n (%) None Chest symptoms Breathing Events Past Year, n (%) Breathing Event Impact, n (%) Missed work or school Total (N=27) Recent COPD (Set 1) (N=8) No COPD > Risk Factors (Set 2) (N=9) No COPD No Pre-Screen (Set 3) (N=10) Clinic visit (15%) (50%) (0%) (0%) Emergency room visit/urgent care (7%) (25%) (0%) (0%) Hospitalisation (4%) (13%) (0%) (0%) None (33%) (0%) (67%) (30%) Cardiovascular 12 (44%) (63%) (33%) (40%) Metabolic (11%) (25%) (11%) (0%) Musculoskeletal (22%) (13%) (11%) (40%) Other (e.g., GI, Cancer) (15%) (0%) (11%) (30%) SF-36 – Physical Component Summary (PCS)3 43 (11); 47 35 (10); 34 48 (9); 50 44 (11); 45 SF-36 – Mental Component Summary (MCS)3 56 (7); 58 54 (9); 59 55 (6); 56 58 (4); 59 COPD Assessment Test (CAT)4 15 (8); 15 21 (8); 22 15 (6); 15 11 (7); 11 Characteristic Non-Respiratory Health Conditions, n (%) Health Status, mean (SD), median Categories are not mutually exclusive Chest congestion, discomfort, tightness, pain, or wheeze Scale: 0–100; higher scores are better Scale: 0–100; higher scores are worse Table Mean (SD) Peak Flow by Device Type and Set Device Electronic Manual Difference Total (N=27) Recent COPD (Set 1) (N=8) No COPD > Risk Factors (Set 2) (N=9) No COPD No Pre-Screen (Set 3) (N=10) 342 (123) 237 (63) 370 (127) 399 (110) 309 (114) 224 (61) 341 (112) 348 (120) 32.67 (49.73) 13.75 (22.70) 29.11 (51.71) 51.00 (60.53) Paired; no statistical tests were performed due to small sample sizes 10 ... developing a screening method for identifying cases of undiagnosed, clinically significant COPD in primary care The cognitive interviews described here were designed to evaluate the clarity of candidate... interpreted as intended Participants were instructed to read the instructions aloud and explain them to the interviewer, in their own words If the instructions were unclear or the interpretation... room in the clinic These cognitive interviews were designed to gather data on the clarity of the instructions and candidate items, including the extent to which each item was understood and interpreted