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Identifying cases of undiagnosed, clinically significant COPD in primary care: qualitative insight from patients in the target population

Identifying cases of undiagnosed, clinically significant COPD in primary care: qualitative... www.nature.com/npjpcrm All rights reserved 2055-1010/15 ARTICLE OPEN Identifying cases of undiagnosed, clinically significant COPD in primary care: qualitative insight from patients in the target population 1 1 1 2 3 4 4 Nancy K Leidy , Katherine Kim , Elizabeth D Bacci , Barbara P Yawn , David M Mannino , Byron M Thomashow , R Graham Barr , 5 5 6 6 7 7 1 Stephen I Rennard , Julia F Houfek , Meilan K Han , Catherine A Meldrum , Barry J Make , Russ P Bowler , Anna W Steenrod , 1 8 9 10 Lindsey T Murray , John W Walsh and Fernando Martinez , for the High-Risk-COPD Screening Study Group 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 (Po0.0001). 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. npj Primary Care Respiratory Medicine (2015) 25, 15024; doi:10.1038/npjpcrm.2015.24; published online 16 April 2015 INTRODUCTION There is evidence suggesting that many patients are first diagnosed with COPD when their airway obstruction has Chronic obstructive pulmonary disease (COPD) is one of the most progressed substantially or during an acute respiratory common lung conditions seen in clinical practice and the fourth 14–19 illness. Studies in primary care suggest that the proportion leading cause of death worldwide. Internationally, data suggest of newly diagnosed COPD patients with moderate-to-severe that only a fraction of those with COPD (9 to 22%) have been 2 airway obstruction in primary care ranges from 43% (Scotland, diagnosed. In the United States, analyses of data from the Third 15 16 Colorado) to 70% (Greece). A United States managed care National Health and Nutrition Examination Survey (NHANES database analysis suggested that 31% were GOLD III or IV, 2007–2010) found that fewer than 50% of adults with airflow whereas a study in China found that 86% were moderate to severe obstruction have been told they have COPD. and 34% had ⩾ 2 exacerbations the prior year. Exacerbation Goals of COPD management include relieving symptoms, history is further exemplified by a study in France where improving exercise capacity and reducing the risk of acute investigators found that 96% of patients with newly diagnosed 4–6 exacerbations of COPD. Long-acting inhaled therapies, supple- chronic bronchitis had been treated with antibiotics for similar mental oxygen and pulmonary rehabilitation are particularly episodes in the past year and 41% had at least two such beneficial to symptomatic patients and to those with a forced episodes. Identifying individuals with undiagnosed clinically expiratory volume in one second (FEV ) less than 60% predicted. significant COPD (FEV o60% predicted or exacerbation risk) Exacerbations are common and costly events associated with decline should set in motion effective medical treatment and improve 7–9 10,11 in lung function, impaired health-related quality of life and short- and long-term health outcomes. death. A history of acute exacerbations of COPD represents the Several instruments have been proposed for COPD case most important risk factor for subsequent events, with treatments identification, defined by airflow limitation (FEV /FVC (forced vital 4,12 20–32 available to decrease frequency and improve outcomes. capacity) o0.70) without reference to exacerbation risk. 1 2 3 4 5 Evidera, Bethesda, MD, USA; Olmsted Medical Center, Rochester, MN, USA; University of Kentucky, Lexington, KY, USA; Columbia University, New York, NY, USA; University of 6 7 8 9 Nebraska, Omaha, NE, USA; University of Michigan, Ann Arbor, MI, USA; National Jewish Health, Denver, CO, USA; COPD Foundation, Washington, DC, USA and Weill Cornell Medical Center, New York, NY, USA. Correspondence: NK Leidy (nancy.leidy@evidera.com) Members of the High-Risk-COPD Screening Study Group are listed after acknowledgements Received 28 August 2014; revised 17 December 2014; accepted 28 December 2014 © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited COPD screening qualitative study NK Leidy et al women in the target population. Ease of use and equivalence of Table 1. Sample diagnostic and risk status classification (N= 50) two PEF metres were also assessed. Group Subgroup Description Number (N) MATERIALS AND METHODS COPD, recently Group 1 COPD—GOLD II 7 diagnosed Diagnosed ⩽ 6 months Study design No history of respiratory This was a two-phase qualitative study: Phase I (elicitation) included focus events in the past year groups and interviews, and Phase II involved cognitive interviews (see Group 2 COPD—GOLD II–IV 13 Online Supplementary). ⩾ 1 respiratory event in the past year Sample Diagnosed ⩽ 6 months At-risk, no COPD Group 3 2–3 risk factors 20 The Phase I sample included participants from one of four categories (see No COPD diagnosis Table 1). COPD severity was based on airflow obstruction, defined by the Group 4 ⩾4 risk factors 10 Global Initiative for Chronic Obstructive Lung Disease (GOLD), and risk No COPD diagnosis factors based on the literature and data mining. Subjects in categories (groups) 1 and 2 provided information on symptoms, risk factors, history Abbreviations: COPD, chronic obstructive pulmonary disease; FEV , forced and other breathing-related issues from the perspective of people recently expiratory volume in one second; GOLD, Global Initiative for Chronic diagnosed with clinically significant COPD—the target population. Groups Obstructive Lung Disease. 3 and 4 were designed to provide insight into how experienced (risk factor) GOLD Stage II (FEV % predicted 50–80%), Stages II–IV (FEV % predicted 1 1 but non-COPD (diagnosis naive) subjects describe their respiratory o50%), pre-bronchodilator. symptoms, risk factors, history and other breathing-related issues. Respiratory event defined by colds, upper respiratory infection, missed Inclusion criteria were as follows: ⩾ 40 years old; stable state spirometry work, clinic visit/ER visit/hospitalisation. (FEV , FEV % predicted, FEV /FVC) in the past 12 months (on file or willing Symptoms (shortness of breath with activity; cough; phlegm (sputum) in 1 1 1 to undergo spirometry at the time of data collection); and able to attend a the absence of a cold, wheezing); exposure (cigarette smoking; second- focus group or telephone interview, read and speak English and to provide hand tobacco or other kinds of smoke at home or work; dust, gases or dirty air at work); health history (asthma; serious childhood breathing written informed consent. Individuals were not eligible if they had physical conditions; colds settling in the chest); recent history (⩾1 respiratory or psychological impairments precluding participation or were hospitalised event in the past year with missed work; clinic or emergency room visit or for a respiratory infection within the past 30 days. Current smokers hospitalisation). (⩾10 pack-years), ex-smokers (history of ⩾ 10 pack-years) and never smokers (⩽100 cigarettes/pipes/cigars in a lifetime) were included. Procedures Methods used to develop these instruments vary widely. Target Participants were recruited from four pulmonary clinics and one primary and test populations range from those with a history of 21,25,29 care clinic in the United States. Convenience sampling was used; clinical cigarette smoking only to populations of smokers and 20,22,26,27,30,32 members of the Study Group approached potential participants by phone non-smokers, and settings that include primary 20–22,26,28,30 or during clinic visits. Efforts were made to recruit a diverse sample in care, specialty clinics and general population terms of age, smoking status and history, gender, race/ethnicity and 25,29,32 screening. A few of these development studies have utilised educational level. The protocol was approved by a central Institutional qualitative research methods to inform and refine instrument Review Board and local Institutional Review Board at each site; written 22,27,28 structure and content or tested the use of peak expiratory informed consent was obtained from all the participants. 29–32 flow (PEF) along with a questionnaire to enhance precision. A 2008 National Institutes of Health (NIH)-COPD Foundation Focus groups and interviews workshop suggested a three-stage approach for identifying Focus groups were held in a private room in the clinic; interviews were undiagnosed individuals with moderate-to-severe airflow obstruc- conducted by telephone. Experienced, trained research staff used a semi- tion (FEV o60%): a questionnaire to eliminate those unlikely to structured interview guide to facilitate discussion. The guide included have severe disease, a simple measure of expiratory airflow to open-ended questions asking participants to describe their breathing- exclude those with normal or near-normal pulmonary function, related symptoms and COPD risk-related experiences; COPD patients were and diagnostic evaluation, including clinical assessment and also asked to consider these issues relative to their recent diagnosis. 33 32 spirometry. Nelson et al. tested the effectiveness of this Sample questions for the COPD Groups (1 and 2) included the following: approach, by screening 5,638 diagnosed and undiagnosed ‘Looking back, were there any ‘signals’ that suggested you might have a individuals from the general population attending public events. breathing condition?’ and ‘What symptoms or experiences did you have that led you to believe you might have a breathing problem?’ Sample In this setting, 6.3% of 3,791 with ⩾ 2 risk factors had abnormal questions for those without COPD (3 and 4) included the following: PEF, suggesting that a more sensitive questionnaire is needed. ‘Describe your breathing for us. Are there any other symptoms you We are developing a new screening method for identifying associate with your breathing?’ and ‘Can you think of any other cases of clinically significant COPD (FEV o60% and/or at risk for experiences related to the symptoms we just discussed?’ acute exacerbations of COPD) in primary care settings. The two- Two researchers were present during focus groups: one served as step process will include a questionnaire and pre-bronchodilator moderator (LTM), while the second observed and took field notes (KK or peak flow (PEF) to identify patients in need of further diagnostic AWS). Groups lasted 1.5–2 h, with breaks taken as needed. Telephone evaluation. PEF will be measured using a familiar, inexpensive and interviews were 1:1 (LTM, KK or AWS), with the interviewer taking notes, widely available device for estimating the presence of airflow and they lasted for 20–50 min. Focus groups and interviews were 31–33 obstruction. Development methods for the questionnaire audio-recorded and transcribed verbatim, with the data cleaned and included a review of the literature, analyses of three existing de-identified for analyses. COPD data sets using random forests methodology and qualitative research with individuals from the target population. Peak expiratory flow This paper presents the qualitative research used to inform Following each focus group or interview, clinical staff performed PEF on thematic content, format, instructions and candidate items for the each participant using electronic (Vitalograph Asma-1 USB, Lenexa, KS, screening questionnaire. The intent was to develop a compre- USA) and manual (Vitalograph AsmaPlan mech PFM) devices. Order of hensive pool of items for empirical testing, maximising content administration was randomised; SafeTway disposable mouthpieces were validity by using words and phrases easily understood by men and used. Upon completion, participants and staff completed ease-of-use npj Primary Care Respiratory Medicine (2015) 15024 © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited COPD screening qualitative study NK Leidy et al Table 2. Sample demographic characteristics Characteristic Total (N = 50) COPD (Groups 1 & 2) (N = 20) Risk, no COPD (Groups 3 & 4) (N = 30) Age, Mean (s.d.) 60 (12) 62 (14) 58 (11) Gender, n (%) Male 24 (48%) 7 (35%) 17 (57%) Ethnicity, n (%) Hispanic or Latino 4/48 (8%) 2 (10%) 2/28 (7%) Not Hispanic or Latino 44/48 (92%) 18 (90%) 26/28 (93%) Racial background, n (%) White 36 (72%) 17 (85%) 19 (63%) Black or African American 13 (26%) 2 (10%) 11 (37%) American Indian or Alaska Native 1 (2%) 1 (5%) 0 (0%) Marital status, n (%) Married 16 (32%) 8 (40%) 8 (27%) Other (single, divorced, separated, widowed) 34 (68%) 12 (60%) 22 (73%) Employment status, n (%) Employed 17 (34%) 6 (30%) 11 (37%) Retired 13 (26%) 8 (40%) 5 (17%) Disabled 14 (28%) 6 (30%) 8 (27%) Other (student, unemployed, other) 9 (18%) 3 (15%) 6 (20%) Education level, n (%) High school or less 16 (32%) 8 (40%) 8 (27%) Some college, vocational training 22 (44%) 6 (30%) 16 (53%) College degree or more 12 (24%) 6 (30%) 6 (20%) Abbreviation: COPD, chronic obstructive pulmonary disease. Categories are not mutually exclusive. ratings (very easy, easy, neither difficult nor easy, difficult or very difficult Candidate questions with instructions were formatted in a questionnaire to use). layout and evaluated by a new set of subjects from the target population using cognitive interviewing methodology (see Online Supplementary). Demographic and clinical measures Participants also completed a sociodemographic and clinical history form, RESULTS the RAND 36-Item Short Form Health Survey (SF-36) and the COPD 38 Eight focus groups (n = 44) and six one-on-one telephone Assessment Tool, a 10- to 15 -min activity following the focus group or interviews (n = 6) were conducted. Sample characteristics are interview. Spirometric values (FEV , FEV % predicted, FEV /FVC) were 1 1 1 summarised in Tables 2 and 3. For the COPD patients, mean obtained for all subjects, either from clinical charts (COPD groups) or by post-bronchodilator FEV was 68% predicted (s.d. = 10) (mean clinical site staff, at the time of the focus group or interview (no bronchodilation). FEV = 2.2 l (s.d. = 0.8)), and time since diagnosis averaged three months. Spirometric values for three cases in the non-COPD groups Data analysis suggested possible airway obstruction; these participants were Using a content analysis approach, data (transcripts) were examined for referred to their physician for follow-up. In two cases, spirometry key themes and constructs. A coding dictionary was developed and ATLAS. was performed after their focus groups. The third case was ti (version 7.1) was used to organise data. Two analysts independently uncovered after screening and enrolment, and the decision was coded the first transcript, and codes were compared and reconciled with senior scientific oversight. Terms and definitions in the coding dictionary made to have him participate in the originally assigned no-COPD were then refined for clarity. The remaining transcripts were coded group so that he could share his experiences in an environment of thematically by one analyst and reviewed by a second analyst, with people without COPD experience. Data from these three cases discrepancies resolved through discussion with the senior analyst. were also examined separately, comparing their responses with Saturation was defined by consistency of themes, construct descriptions others. or terms across groups and interviews. Six major themes were identified in the data: (1) exposure to Descriptive statistics were used to summarise sample characteristics, PEF smoke and other pollutants (e.g., chemicals, paint, gasoline), either values and PEF ease of use. A two-way analysis of variance was used to through a friend/relative, work environment or living condition; determine whether there was a significant difference between electronic (2) personal and family history of respiratory health conditions, and manual PEF values for participants with and without COPD. Paired- such as emphysema, pneumonia, frequent colds and sinus sample t-tests were used to compare PEF values between the electronic and manual devices within groups. infections; (3) recent history of respiratory events, including factors that may trigger an event (perfumes, cigarette smoke, exertion) and recent clinic visits or hospitalisations owing to Item pool development and cognitive interviewing 34 respiratory symptoms such as shortness of breath, coughing and Results were examined together with those from the literature review chest tightness that continued to worsen; (4) symptoms, including and data mining to inform the development of a pool of candidate respiratory (e.g., shortness of breath with and without exertion, questions for further evaluation and testing. Items were generated using sputum and phlegm production, wheezing, chest tightness and an iterative process of development, review, revision, discussion and revision, with input from the High-Risk-COPD Screening Study Group. congestion) and nonrespiratory (e.g., feeling tired after slight © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited npj Primary Care Respiratory Medicine (2015) 15024 COPD screening qualitative study NK Leidy et al Table 3. Sample clinical characteristics Characteristic Total (N = 50) COPD (Groups 1 & 2) (N = 20) Risk, no COPD (Groups 3 & 4) (N = 30) Smoking status and history Never smoked, n (%) 17 (34%) 3 (15%) 14 (47%) Smoked cigarettes, n (%) 32 (64%) 17 (85%) 15 (50%) Former, n (%) 16/32 (50%) 6/17 (35%) 10/15 (67%) Current, n (%) 16/32 (50%) 11/17 (65%) 5/15 (33%) Age started smoking, mean (s.d.) 17 (4) 17 (5) 17 (4) Duration of smoking (years) 33 (13) 37 (10) 29 (14) Pack-years 40 (32) 44 (34) 34 (30) Other risk factors, n (%) Yes History of asthma 20 (40%) 9 (45%) 11 (37%) Exposure (smoke, dust, gas, air) 41 (82%) 18 (90%) 23 (77%) Colds move to chest 35 (70%) 16 (80%) 19 (63%) Childhood breathing conditions 7/49 (14%) 3/19 (16%) 4 (13%) Family history of breathing problems 22 (44%) 9 (45%) 13 (43%) Breathing-related symptoms , n (%) None 3 (6%) 1 (5%) 2 (7%) Chest symptoms 26 (52%) 13 (65%) 13 (42%) Cough 28 (56%) 15 (75%) 13 (43%) Shortness of breath (overall) 42 (84%) 16 (80%) 26 (87%) With strenuous activity 38 (76%) 15 (75%) 23 (77%) With light activity 25 (50%) 13 (65%) 12 (40%) At rest 9 (18%) 5 (25%) 4 (13%) Breathing events past year, n (%) None 18 (36%) 3 (15%) 15 (50%) Cold 18 (36%) 13 (65%) 5 (17%) Chest infection or pneumonia 16 (32%) 10 (50%) 6 (20%) Breathing event impact, n (%) Missed work or school 9 (18%) 5 (25%) 4 (13%) Clinic visit 15 (30%) 5 (25%) 10 (33%) Emergency room visit/urgent care 10 (20%) 6 (30%) 4 (13%) Hospitalisation 3 (6%) 2 (10%) 1 (3%) Non-respiratory health conditions, n (%) None 7 (14%) 0 (0%) 7 (23%) Cardiovascular 20 (40%) 8 (40%) 12 (40%) Metabolic 7 (14%) 0 (0%) 7 (23%) Musculoskeletal 14 (28%) 9 (45%) 5 (17%) Other (e.g., GI, cancer) 17 (34%) 5 (25%) 12 (40%) Health status, mean (s.d.), median d d SF-36—Physical Component Summary (PCS) 38 (12); 37 36 (13) ; 37 39 (12) ;37 e e SF-36—Mental Component Summary (MCS) 47 (13); 50 46 (11) ; 46 47 (14) ;51 f f COPD Assessment Test (CAT) 17 (9); 18 19 (9) ; 19 16 (8) ;17 Abbreviations: COPD, chronic obstructive pulmonary disease; GI, gastrointestinal; NS, not significant. Pack-years = (cigarettes per day/20 cigarettes per pack) × duration of smoking (years). Categories are not mutually exclusive. Chest congestion, discomfort, tightness, pain or wheeze. Scale: 0–100; higher scores are better; t= 0.91: COPD versus non-COPD, NS, P= 0.37. Scale: 0–100; higher scores are better t= 0.28: COPD versus non-COPD, NS, P= 0.78. Scale: 0–100; higher scores are worse t= 1.49: COPD versus non-COPD, NS, P= 1.4. exertion, low energy, sleeping problems such as waking up at sputum/phlegm (100%); tight, wheezy or noisy chest (90%); night feeling short of breath); (5) impact of breathing-related slowing down (40%); fatigue (50%); and sleep problems (40%). No problems on daily life (e.g., slowing down or stopping owing to qualitative differences were found between data provided by the breathlessness, unable to complete daily chores, unable to keep three subjects with evidence of airway obstruction and other up with others); and (6) the attribution of symptoms or participants. Sample quotes for each theme are shown in Table 4. experiences (e.g., breathless, being tired or slowing down Candidate item content is shown in Table 5. attributed to age or weight; cough attributed to smoking or Electronic and manual PEF devices were rated as ‘easy’ or ‘very smoke exposure). easy’ to use by participants (96%; 94%) and clinical site staff (80%; Themes were consistent across COPD and non-COPD partici- 84%). PEF values by device and group are shown in Table 6. pants, with some cross-group variation in emphasis within each With the data analysed, a draft questionnaire with 48 candidate theme. Spontaneous symptom reporting rates were generally items was constructed and subjected to cognitive interviewing in lowest for Group 3 (non-COPD ⩽ 2 risk factors); rates for Group 4 a separate sample of 27 subjects. The instructions and item pool (non-COPD, ⩾ 4 risk factors) were similar to the COPD groups on were easily understood and appropriately interpreted by the npj Primary Care Respiratory Medicine (2015) 15024 © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited COPD screening qualitative study NK Leidy et al Table 4. Key themes and representative quotes Exposure: 3: 004-102 All my family smokes. 2: 002-110 I worked in a tobacco warehouse for about a year…I was a…dancer for 13 years, barroom smoke. 2: 001-101 Working with material, fuzzy material and breathing it in. 1: 002-101 Around different chemicals, paint, plastic, you name it and we did it all. Personal and family history: 2: 001-139 J My parents were both smokers…my mother was 92 when she was diagnosed with COPD and my father died of emphysema. J When it takes that long to recover from 1, when you have like 2 or 3 in the course of a 3 or 4-month winter…it ends up you’re feeling—you’re feeling 1: 001-145 crummy for 75% of the time. 2: 006-104 J I’ve gotten sinus infections in the spring and the fall, I bet, for the last 10 years…and I think like 5 times it has ended up as pneumonia. ;I’ve had 3: 004-125 pneumonia … maybe 7, 8 times in my life. Recent history: 2: 001-123 J The smell of—of detergents and, uh, lovely perfumes do affect, um, my deep breathing. J If I’m going to be around dust or chemicals or cigarette smoke…I have to wear a mask because if not, it will be like, uh, I will, uh, start feeling the 3: 004-127 tightness in midst of—at first sign, it’s like my chest will start tightening up. 4: 003-131 J You’re trying to breathe and it hurts, and it hurts and you have pain and then it hurts and …then go to the hospital for it—it’s the lungs. Symptoms—respiratory and non-respiratory: 2: 002-110 Just feels like you've got like something like a ton of bricks just sitting on your chest. I wouldn't have any trouble breathing hardly, but I'd just be running short on breath. Like I could walk a country mile, like a stroll, but I can't go up a flight 1: 002-103 of stairs if I get in a hurry. 2: 002-106 I walk up the driveway to my car, and--I'm really tired after that. I feel me [panting] breathing…you kind of feel tired all the time. Impact: 2: 001-141 I’d go out to lunch with…people from my office… I’d really have to kind of push myself to keep up with them ….had to work to keep up. 1: 002-113 I have a hard time…climbing stairs, and I've got to take it slow. I have to walk slowly. 4: 002-113 Walk up and down them halls, and sometimes I just feel like okay, wait, and I stop for a minute. Attribution: 2: 002-109 I've got a smoker's cough because I smoke. 1: 002-101 I noticed I was starting to slow down with my breathing, but it actually got worse after I started having all this other health issues. Abbreviation: COPD, chronic obstructive pulmonary disease. Superscripts show subgroup membership and patient ID. Table 5. Key themes and candidate content Theme Candidate content Exposure Smoking (current, history) Second-hand smoke ‘Dirty’ air Personal and family history Family smoking history Relatives with COPD, lung cancer, asthma Personal history of recurrent chest infections/colds Recent history Environmental triggers affect breathing Colds, acute bronchitis Clinic visits for or with breathing-related problems Hospitalisations for or with breathing-related problems Missed school or work days owing to breathing-related problems Symptoms Respiratory: dyspnoea, cough, sputum, chest congestion, wheezy/noisy breathing, chest tightness, chest heavy Non-respiratory: fatigue, feeling tired, lack of energy, sleep difficulties, slowing down Impact Activity limitations—stairs, steps, walking quickly Frequent stopping, keeping up with others Attribution Symptom attribution to smoking, age, weight or other health conditions Abbreviation: COPD, chronic obstructive pulmonary disease. © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited npj Primary Care Respiratory Medicine (2015) 15024 COPD screening qualitative study NK Leidy et al identifying undiagnosed COPD. Cough, phlegm, dyspnoea and Table 6. Mean (s.d.) peak flow by device type and group 21–23 wheeze, as well as history of chest infections, breathing- 23,24 related disability or hospitalisations, for example, were Device Total (N = 50) COPD Risk, no COPD broached and characterised by these participants. In addition, (Groups 1 & 2) (Groups 3 & 4) (N = 20) (N = 30) however, subjects described chest symptoms, including conges- tion, noisy or tight, as well as feelings of fatigue and sleep Electronic 362 (158) 274 (124) 424 (151) difficulties. Participant descriptions of family history of respiratory- Manual 315 (131) 249 (104) 358 (130) related problems, symptoms, activity limitations and acute a a Difference 43.79 (60.76) 24.89 (38.69) 57.09 (70.05) b c d respiratory illnesses offer new insight into candidate items for t= 4.89 t = 2.80 t= 4.23 identifying undiagnosed cases of clinically significant COPD. Abbreviation: ANOVA, analysis of variance; COPD, chronic obstructive Smokers and non-smokers were included to facilitate the use of pulmonary disease. the questionnaire in both groups. There is evidence to suggest ANOVA testing group effects showed no difference (F= 3.29, P= 0.076). that one-fourth to one-third of all COPD cases are non-smokers, Paired t-test,Po0.0001. c with country-to-country variability. The international study of Paired t-test, Po0.05. Lamprecht et al. found that 81% of never smokers with Paired t-test, Po0.001. moderate-to-severe airway obstruction were undiagnosed. The study of Bednarek et al. in Poland suggested that detection of COPD is reduced by 26% when a ‘smokers only’ criterion is used, subjects; several adjustments were made to enhance clarity. PEF whereas in the Third US NHANES database, ‘never smokers’ results were similar to those found in the elicitation sample (see accounted for 23% of airway obstruction cases, 69% of whom had Online Supplementary). 43 no prior respiratory diagnosis. Sample clinical characteristics provide further qualitative insight into the challenges associated with variable selection for case DISCUSSION identification. Descriptively, the frequency of breathing-related Main findings symptoms (e.g., cough, shortness of breath) and other risk factors This qualitative study is part of a larger multi-method approach to (e.g., history of asthma, family history of breathing problems) were develop a screening method for identifying patients with similar across groups. The COPD group reported more breathing undiagnosed, clinically significant COPD in primary care. Six key events over the past year (e.g., cold, chest infection). Although themes were identified; candidate items were developed, using there were no significant differences in health status between the words and phrases easily understood by people in the target two groups, the descriptively higher COPD Assessment Test scores population. Although participants and clinical staff rated the two for COPD subjects suggest a trend toward poorer health in areas PEF devices easy to use, values produced by the electronic device specific to COPD, with the mean between-group difference were significantly higher than those provided by the manual exceeding the proposed two-point minimum clinically important device. difference. These exploratory results suggest that a small set of targeted questions may be more effective than a large number of general health questions for identifying people with COPD. Strengths and limitations of this study This is among the first known uses of qualitative data to inform the development of a screening tool for COPD case identification Implications for future research, policy and practice in a clinical setting. The study included men and women with As part of our screening tool development, we will be testing the varied COPD experiences, risk factors and education. The fact that added value of including PEF to increase sensitivity and specificity. all subjects were from the United States and most were white To facilitate and optimise utilisation of PEF as part of the screening (70%) and not Hispanic or Latino (92%) is a limitation of the study. process, we evaluated the usability and comparability of electronic In addition, although a larger number of subjects with undiag- and manual devices. Most patients and clinic staff rated the nosed COPD would have been ideal, a study design that explicitly devices easy or very easy to use, suggesting that either might be included screening and identifying subjects with undiagnosed suitable. However, differences in PEF values indicate a need for clinically significant COPD (using methods not designed for this standardisation to simplify the process by providing a single purpose) would have been cost-prohibitive. The fact that all threshold for interpretation. With cost and availability in mind, the moderators and interviewers were female may have influenced manual PEF device will be tested further during the next phase of participant responses, although staff were experienced and screening tool development. The questionnaire’s sensitivity and trained to encourage discussion and minimise bias. specificity will be optimised independently of PEF, and thus those preferring to use FEV or PEF captured through an electronic/ digital device would be free to do so, applying their preferred Interpretation of findings in relation to previously published work threshold for follow-up evaluation. The attribution theme offers insight into why certain symptoms are not reported or recognised as indicators of COPD. Participants Conclusions who smoked often attributed their cough to smoking; others attributed slowing down, feeling tired or becoming breathless This qualitative study is part of a multi-method approach for with exertion to ageing, weight or other health issues. These developing a new screening method for identifying primary care findings are consistent with descriptions of barriers to diagnosis; patients who may have undiagnosed, clinically significant COPD. quantitative evidence that symptom-based diagnosis of COPD in Six themes were identified: exposure, personal and family health, primary care settings is unreliable, particularly if patients are recent history of respiratory events, respiratory and non- overweight; and qualitative research suggesting that people respiratory symptoms, impact, and attribution. A pool of 48 minimise and negotiate the importance of symptoms and need to candidate items was developed and revised based on cognitive acknowledge ‘there must be something wrong’ as part of the interview results. Items will be tested and eliminated during the diagnostic process. next phase of instrument development, with the intent of finding Most of the respiratory symptoms identified in this study were the best, smallest set of questions that, together with PEF, can consistent with existing, symptom-based questionnaires for identify patients in need of diagnostic evaluation for COPD. npj Primary Care Respiratory Medicine (2015) 15024 © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited COPD screening qualitative study NK Leidy et al medical presentations in COPD or IPF for the American College of Chest Physicians, ACKNOWLEDGEMENTS the American Thoracic Society, CME Incite, Center for Health Care Education, Inova The authors thank Sarah Clifford for her comments during protocol development and Health Systems, MedScape, Miller Medical, National Association for Continuing Kathryn Miller for text editing and formatting the protocol and manuscript. Education, Paradigm, Peer Voice, Projects in Knowledge, Spectrum Health System, St John’s Hospital, St Mary’s Hospital, University of Illinois Chicago, University of Texas HIGH-RISK-COPD SCREENING STUDY GROUP Southwestern, University of Virginia, UpToDate and Wayne State University. FM has Rebecca Copeland, University of Kentucky; Tim Dorius, University of Nebraska participated in data safety monitoring committees sponsored by GSK and Stromedix. Medical Center; David Hengerer, Evidera; Patricia Jellen, New York Presbyterian He has aided with FDA presentations sponsored by Boehringer Ingelheim, GSK and Hospital; Marge Kurland, Olmsted Medical Center; Karen Malley, Evidera; Jason Ikaria. He has spoken on COPD for Bayer, Forest, GSK and Nycomed/Takeda. He has Shiffermiller, University of Nebraska Medical Center; Christina Schnell, National Jewish participated in advisory teleconferences sponsored by the American Institute for Health; Lori Silveira, National Jewish Health; Sonja Stringer, Evidera; Deb Sumnick, Research, Axon, Grey Healthcare, Johnson & Johnson and Merion. He has received University of Nebraska; Randel Plant, COPD Foundation; Jennifer Underwood, book royalties from Informa. National Jewish Health; Beth Whippo, New York Presbyterian Hospital. CONTRIBUTIONS FUNDING Each named author participated in the study design and data analyses and Funding for this work was provided by the National Heart, Lung, and Blood Institute interpretation. BPY, DMM, BMT, RGB, SIR, JFH, MKH, CAM, RPB and FM also NHLBI: R01 HL 114055. Additional support was provided by NHLBI:R01 HL089856 and participated in subject recruitment and data collection activities; LTM, KK and AWS R01 HL089897. served as focus group moderators, field note takers and interviewers. NKL, EDB, KK, AWS and LTM contributed to data management, analyses and interpretation. All the authors participated in manuscript development, review and/or editing. NKL, DMM and FM serve as co-investigators of the grant and, together with the co-authors, REFERENCES attest to the accuracy of the information contained in this manuscript. 1 Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med 2006; 3:e442. 2 Bednarek M, Maciejewski J, Wozniak M, Kuca P, Zielinski J. Prevalence, severity COMPETING INTERESTS and underdiagnosis of COPD in the primary care setting. Thorax 2008; 63: 402–407. 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Prim Care Respir J 2011; 20: analysis. Lancet Respir Med 2014; 2: 195–203. 184–189. 31 Jithoo A, Enright PL, Burney P, Buist AS, Bateman ED, Tan WC et al. Case-finding options for COPD: results from the Burden of Obstructive Lung Disease study. Eur This work is licensed under a Creative Commons Attribution- Respir J 2013; 41: 548–555. NonCommercial-NoDerivatives 4.0 International License. The images 32 Nelson SB, LaVange LM, Nie Y, Walsh JW, Enright PL, Martinez FJ et al. or other third party material in this article are included in the article’s Creative Commons Questionnaires and pocket spirometers provide an alternative approach for COPD license, unless indicated otherwise in the credit line; if the material is not included under screening in the general population. Chest 2012; 142: 358–366. the Creative Commons license, users will need to obtain permission from the license 33 Martinez FJ. NHLBI Workshop: A Case-finding Strategy for Moderate-to-Severe holder to reproduce the material. To view a copy of this license, visit http:// COPD in the United States Executive Summary. November 2009. http:// creativecommons.org/licenses/by-nc-nd/4.0/ Supplementary Information accompanies the paper on the npj Primary Care Respiratory Medicine website (http://www.nature.com/npjpcrm) npj Primary Care Respiratory Medicine (2015) 15024 © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png npj Primary Care Respiratory Medicine Springer Journals

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Medicine & Public Health; Medicine/Public Health, general; Primary Care Medicine; Internal Medicine; Pneumology/Respiratory System; Thoracic Surgery
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www.nature.com/npjpcrm All rights reserved 2055-1010/15 ARTICLE OPEN Identifying cases of undiagnosed, clinically significant COPD in primary care: qualitative insight from patients in the target population 1 1 1 2 3 4 4 Nancy K Leidy , Katherine Kim , Elizabeth D Bacci , Barbara P Yawn , David M Mannino , Byron M Thomashow , R Graham Barr , 5 5 6 6 7 7 1 Stephen I Rennard , Julia F Houfek , Meilan K Han , Catherine A Meldrum , Barry J Make , Russ P Bowler , Anna W Steenrod , 1 8 9 10 Lindsey T Murray , John W Walsh and Fernando Martinez , for the High-Risk-COPD Screening Study Group 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 (Po0.0001). 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. npj Primary Care Respiratory Medicine (2015) 25, 15024; doi:10.1038/npjpcrm.2015.24; published online 16 April 2015 INTRODUCTION There is evidence suggesting that many patients are first diagnosed with COPD when their airway obstruction has Chronic obstructive pulmonary disease (COPD) is one of the most progressed substantially or during an acute respiratory common lung conditions seen in clinical practice and the fourth 14–19 illness. Studies in primary care suggest that the proportion leading cause of death worldwide. Internationally, data suggest of newly diagnosed COPD patients with moderate-to-severe that only a fraction of those with COPD (9 to 22%) have been 2 airway obstruction in primary care ranges from 43% (Scotland, diagnosed. In the United States, analyses of data from the Third 15 16 Colorado) to 70% (Greece). A United States managed care National Health and Nutrition Examination Survey (NHANES database analysis suggested that 31% were GOLD III or IV, 2007–2010) found that fewer than 50% of adults with airflow whereas a study in China found that 86% were moderate to severe obstruction have been told they have COPD. and 34% had ⩾ 2 exacerbations the prior year. Exacerbation Goals of COPD management include relieving symptoms, history is further exemplified by a study in France where improving exercise capacity and reducing the risk of acute investigators found that 96% of patients with newly diagnosed 4–6 exacerbations of COPD. Long-acting inhaled therapies, supple- chronic bronchitis had been treated with antibiotics for similar mental oxygen and pulmonary rehabilitation are particularly episodes in the past year and 41% had at least two such beneficial to symptomatic patients and to those with a forced episodes. Identifying individuals with undiagnosed clinically expiratory volume in one second (FEV ) less than 60% predicted. significant COPD (FEV o60% predicted or exacerbation risk) Exacerbations are common and costly events associated with decline should set in motion effective medical treatment and improve 7–9 10,11 in lung function, impaired health-related quality of life and short- and long-term health outcomes. death. A history of acute exacerbations of COPD represents the Several instruments have been proposed for COPD case most important risk factor for subsequent events, with treatments identification, defined by airflow limitation (FEV /FVC (forced vital 4,12 20–32 available to decrease frequency and improve outcomes. capacity) o0.70) without reference to exacerbation risk. 1 2 3 4 5 Evidera, Bethesda, MD, USA; Olmsted Medical Center, Rochester, MN, USA; University of Kentucky, Lexington, KY, USA; Columbia University, New York, NY, USA; University of 6 7 8 9 Nebraska, Omaha, NE, USA; University of Michigan, Ann Arbor, MI, USA; National Jewish Health, Denver, CO, USA; COPD Foundation, Washington, DC, USA and Weill Cornell Medical Center, New York, NY, USA. Correspondence: NK Leidy (nancy.leidy@evidera.com) Members of the High-Risk-COPD Screening Study Group are listed after acknowledgements Received 28 August 2014; revised 17 December 2014; accepted 28 December 2014 © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited COPD screening qualitative study NK Leidy et al women in the target population. Ease of use and equivalence of Table 1. Sample diagnostic and risk status classification (N= 50) two PEF metres were also assessed. Group Subgroup Description Number (N) MATERIALS AND METHODS COPD, recently Group 1 COPD—GOLD II 7 diagnosed Diagnosed ⩽ 6 months Study design No history of respiratory This was a two-phase qualitative study: Phase I (elicitation) included focus events in the past year groups and interviews, and Phase II involved cognitive interviews (see Group 2 COPD—GOLD II–IV 13 Online Supplementary). ⩾ 1 respiratory event in the past year Sample Diagnosed ⩽ 6 months At-risk, no COPD Group 3 2–3 risk factors 20 The Phase I sample included participants from one of four categories (see No COPD diagnosis Table 1). COPD severity was based on airflow obstruction, defined by the Group 4 ⩾4 risk factors 10 Global Initiative for Chronic Obstructive Lung Disease (GOLD), and risk No COPD diagnosis factors based on the literature and data mining. Subjects in categories (groups) 1 and 2 provided information on symptoms, risk factors, history Abbreviations: COPD, chronic obstructive pulmonary disease; FEV , forced and other breathing-related issues from the perspective of people recently expiratory volume in one second; GOLD, Global Initiative for Chronic diagnosed with clinically significant COPD—the target population. Groups Obstructive Lung Disease. 3 and 4 were designed to provide insight into how experienced (risk factor) GOLD Stage II (FEV % predicted 50–80%), Stages II–IV (FEV % predicted 1 1 but non-COPD (diagnosis naive) subjects describe their respiratory o50%), pre-bronchodilator. symptoms, risk factors, history and other breathing-related issues. Respiratory event defined by colds, upper respiratory infection, missed Inclusion criteria were as follows: ⩾ 40 years old; stable state spirometry work, clinic visit/ER visit/hospitalisation. (FEV , FEV % predicted, FEV /FVC) in the past 12 months (on file or willing Symptoms (shortness of breath with activity; cough; phlegm (sputum) in 1 1 1 to undergo spirometry at the time of data collection); and able to attend a the absence of a cold, wheezing); exposure (cigarette smoking; second- focus group or telephone interview, read and speak English and to provide hand tobacco or other kinds of smoke at home or work; dust, gases or dirty air at work); health history (asthma; serious childhood breathing written informed consent. Individuals were not eligible if they had physical conditions; colds settling in the chest); recent history (⩾1 respiratory or psychological impairments precluding participation or were hospitalised event in the past year with missed work; clinic or emergency room visit or for a respiratory infection within the past 30 days. Current smokers hospitalisation). (⩾10 pack-years), ex-smokers (history of ⩾ 10 pack-years) and never smokers (⩽100 cigarettes/pipes/cigars in a lifetime) were included. Procedures Methods used to develop these instruments vary widely. Target Participants were recruited from four pulmonary clinics and one primary and test populations range from those with a history of 21,25,29 care clinic in the United States. Convenience sampling was used; clinical cigarette smoking only to populations of smokers and 20,22,26,27,30,32 members of the Study Group approached potential participants by phone non-smokers, and settings that include primary 20–22,26,28,30 or during clinic visits. Efforts were made to recruit a diverse sample in care, specialty clinics and general population terms of age, smoking status and history, gender, race/ethnicity and 25,29,32 screening. A few of these development studies have utilised educational level. The protocol was approved by a central Institutional qualitative research methods to inform and refine instrument Review Board and local Institutional Review Board at each site; written 22,27,28 structure and content or tested the use of peak expiratory informed consent was obtained from all the participants. 29–32 flow (PEF) along with a questionnaire to enhance precision. A 2008 National Institutes of Health (NIH)-COPD Foundation Focus groups and interviews workshop suggested a three-stage approach for identifying Focus groups were held in a private room in the clinic; interviews were undiagnosed individuals with moderate-to-severe airflow obstruc- conducted by telephone. Experienced, trained research staff used a semi- tion (FEV o60%): a questionnaire to eliminate those unlikely to structured interview guide to facilitate discussion. The guide included have severe disease, a simple measure of expiratory airflow to open-ended questions asking participants to describe their breathing- exclude those with normal or near-normal pulmonary function, related symptoms and COPD risk-related experiences; COPD patients were and diagnostic evaluation, including clinical assessment and also asked to consider these issues relative to their recent diagnosis. 33 32 spirometry. Nelson et al. tested the effectiveness of this Sample questions for the COPD Groups (1 and 2) included the following: approach, by screening 5,638 diagnosed and undiagnosed ‘Looking back, were there any ‘signals’ that suggested you might have a individuals from the general population attending public events. breathing condition?’ and ‘What symptoms or experiences did you have that led you to believe you might have a breathing problem?’ Sample In this setting, 6.3% of 3,791 with ⩾ 2 risk factors had abnormal questions for those without COPD (3 and 4) included the following: PEF, suggesting that a more sensitive questionnaire is needed. ‘Describe your breathing for us. Are there any other symptoms you We are developing a new screening method for identifying associate with your breathing?’ and ‘Can you think of any other cases of clinically significant COPD (FEV o60% and/or at risk for experiences related to the symptoms we just discussed?’ acute exacerbations of COPD) in primary care settings. The two- Two researchers were present during focus groups: one served as step process will include a questionnaire and pre-bronchodilator moderator (LTM), while the second observed and took field notes (KK or peak flow (PEF) to identify patients in need of further diagnostic AWS). Groups lasted 1.5–2 h, with breaks taken as needed. Telephone evaluation. PEF will be measured using a familiar, inexpensive and interviews were 1:1 (LTM, KK or AWS), with the interviewer taking notes, widely available device for estimating the presence of airflow and they lasted for 20–50 min. Focus groups and interviews were 31–33 obstruction. Development methods for the questionnaire audio-recorded and transcribed verbatim, with the data cleaned and included a review of the literature, analyses of three existing de-identified for analyses. COPD data sets using random forests methodology and qualitative research with individuals from the target population. Peak expiratory flow This paper presents the qualitative research used to inform Following each focus group or interview, clinical staff performed PEF on thematic content, format, instructions and candidate items for the each participant using electronic (Vitalograph Asma-1 USB, Lenexa, KS, screening questionnaire. The intent was to develop a compre- USA) and manual (Vitalograph AsmaPlan mech PFM) devices. Order of hensive pool of items for empirical testing, maximising content administration was randomised; SafeTway disposable mouthpieces were validity by using words and phrases easily understood by men and used. Upon completion, participants and staff completed ease-of-use npj Primary Care Respiratory Medicine (2015) 15024 © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited COPD screening qualitative study NK Leidy et al Table 2. Sample demographic characteristics Characteristic Total (N = 50) COPD (Groups 1 & 2) (N = 20) Risk, no COPD (Groups 3 & 4) (N = 30) Age, Mean (s.d.) 60 (12) 62 (14) 58 (11) Gender, n (%) Male 24 (48%) 7 (35%) 17 (57%) Ethnicity, n (%) Hispanic or Latino 4/48 (8%) 2 (10%) 2/28 (7%) Not Hispanic or Latino 44/48 (92%) 18 (90%) 26/28 (93%) Racial background, n (%) White 36 (72%) 17 (85%) 19 (63%) Black or African American 13 (26%) 2 (10%) 11 (37%) American Indian or Alaska Native 1 (2%) 1 (5%) 0 (0%) Marital status, n (%) Married 16 (32%) 8 (40%) 8 (27%) Other (single, divorced, separated, widowed) 34 (68%) 12 (60%) 22 (73%) Employment status, n (%) Employed 17 (34%) 6 (30%) 11 (37%) Retired 13 (26%) 8 (40%) 5 (17%) Disabled 14 (28%) 6 (30%) 8 (27%) Other (student, unemployed, other) 9 (18%) 3 (15%) 6 (20%) Education level, n (%) High school or less 16 (32%) 8 (40%) 8 (27%) Some college, vocational training 22 (44%) 6 (30%) 16 (53%) College degree or more 12 (24%) 6 (30%) 6 (20%) Abbreviation: COPD, chronic obstructive pulmonary disease. Categories are not mutually exclusive. ratings (very easy, easy, neither difficult nor easy, difficult or very difficult Candidate questions with instructions were formatted in a questionnaire to use). layout and evaluated by a new set of subjects from the target population using cognitive interviewing methodology (see Online Supplementary). Demographic and clinical measures Participants also completed a sociodemographic and clinical history form, RESULTS the RAND 36-Item Short Form Health Survey (SF-36) and the COPD 38 Eight focus groups (n = 44) and six one-on-one telephone Assessment Tool, a 10- to 15 -min activity following the focus group or interviews (n = 6) were conducted. Sample characteristics are interview. Spirometric values (FEV , FEV % predicted, FEV /FVC) were 1 1 1 summarised in Tables 2 and 3. For the COPD patients, mean obtained for all subjects, either from clinical charts (COPD groups) or by post-bronchodilator FEV was 68% predicted (s.d. = 10) (mean clinical site staff, at the time of the focus group or interview (no bronchodilation). FEV = 2.2 l (s.d. = 0.8)), and time since diagnosis averaged three months. Spirometric values for three cases in the non-COPD groups Data analysis suggested possible airway obstruction; these participants were Using a content analysis approach, data (transcripts) were examined for referred to their physician for follow-up. In two cases, spirometry key themes and constructs. A coding dictionary was developed and ATLAS. was performed after their focus groups. The third case was ti (version 7.1) was used to organise data. Two analysts independently uncovered after screening and enrolment, and the decision was coded the first transcript, and codes were compared and reconciled with senior scientific oversight. Terms and definitions in the coding dictionary made to have him participate in the originally assigned no-COPD were then refined for clarity. The remaining transcripts were coded group so that he could share his experiences in an environment of thematically by one analyst and reviewed by a second analyst, with people without COPD experience. Data from these three cases discrepancies resolved through discussion with the senior analyst. were also examined separately, comparing their responses with Saturation was defined by consistency of themes, construct descriptions others. or terms across groups and interviews. Six major themes were identified in the data: (1) exposure to Descriptive statistics were used to summarise sample characteristics, PEF smoke and other pollutants (e.g., chemicals, paint, gasoline), either values and PEF ease of use. A two-way analysis of variance was used to through a friend/relative, work environment or living condition; determine whether there was a significant difference between electronic (2) personal and family history of respiratory health conditions, and manual PEF values for participants with and without COPD. Paired- such as emphysema, pneumonia, frequent colds and sinus sample t-tests were used to compare PEF values between the electronic and manual devices within groups. infections; (3) recent history of respiratory events, including factors that may trigger an event (perfumes, cigarette smoke, exertion) and recent clinic visits or hospitalisations owing to Item pool development and cognitive interviewing 34 respiratory symptoms such as shortness of breath, coughing and Results were examined together with those from the literature review chest tightness that continued to worsen; (4) symptoms, including and data mining to inform the development of a pool of candidate respiratory (e.g., shortness of breath with and without exertion, questions for further evaluation and testing. Items were generated using sputum and phlegm production, wheezing, chest tightness and an iterative process of development, review, revision, discussion and revision, with input from the High-Risk-COPD Screening Study Group. congestion) and nonrespiratory (e.g., feeling tired after slight © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited npj Primary Care Respiratory Medicine (2015) 15024 COPD screening qualitative study NK Leidy et al Table 3. Sample clinical characteristics Characteristic Total (N = 50) COPD (Groups 1 & 2) (N = 20) Risk, no COPD (Groups 3 & 4) (N = 30) Smoking status and history Never smoked, n (%) 17 (34%) 3 (15%) 14 (47%) Smoked cigarettes, n (%) 32 (64%) 17 (85%) 15 (50%) Former, n (%) 16/32 (50%) 6/17 (35%) 10/15 (67%) Current, n (%) 16/32 (50%) 11/17 (65%) 5/15 (33%) Age started smoking, mean (s.d.) 17 (4) 17 (5) 17 (4) Duration of smoking (years) 33 (13) 37 (10) 29 (14) Pack-years 40 (32) 44 (34) 34 (30) Other risk factors, n (%) Yes History of asthma 20 (40%) 9 (45%) 11 (37%) Exposure (smoke, dust, gas, air) 41 (82%) 18 (90%) 23 (77%) Colds move to chest 35 (70%) 16 (80%) 19 (63%) Childhood breathing conditions 7/49 (14%) 3/19 (16%) 4 (13%) Family history of breathing problems 22 (44%) 9 (45%) 13 (43%) Breathing-related symptoms , n (%) None 3 (6%) 1 (5%) 2 (7%) Chest symptoms 26 (52%) 13 (65%) 13 (42%) Cough 28 (56%) 15 (75%) 13 (43%) Shortness of breath (overall) 42 (84%) 16 (80%) 26 (87%) With strenuous activity 38 (76%) 15 (75%) 23 (77%) With light activity 25 (50%) 13 (65%) 12 (40%) At rest 9 (18%) 5 (25%) 4 (13%) Breathing events past year, n (%) None 18 (36%) 3 (15%) 15 (50%) Cold 18 (36%) 13 (65%) 5 (17%) Chest infection or pneumonia 16 (32%) 10 (50%) 6 (20%) Breathing event impact, n (%) Missed work or school 9 (18%) 5 (25%) 4 (13%) Clinic visit 15 (30%) 5 (25%) 10 (33%) Emergency room visit/urgent care 10 (20%) 6 (30%) 4 (13%) Hospitalisation 3 (6%) 2 (10%) 1 (3%) Non-respiratory health conditions, n (%) None 7 (14%) 0 (0%) 7 (23%) Cardiovascular 20 (40%) 8 (40%) 12 (40%) Metabolic 7 (14%) 0 (0%) 7 (23%) Musculoskeletal 14 (28%) 9 (45%) 5 (17%) Other (e.g., GI, cancer) 17 (34%) 5 (25%) 12 (40%) Health status, mean (s.d.), median d d SF-36—Physical Component Summary (PCS) 38 (12); 37 36 (13) ; 37 39 (12) ;37 e e SF-36—Mental Component Summary (MCS) 47 (13); 50 46 (11) ; 46 47 (14) ;51 f f COPD Assessment Test (CAT) 17 (9); 18 19 (9) ; 19 16 (8) ;17 Abbreviations: COPD, chronic obstructive pulmonary disease; GI, gastrointestinal; NS, not significant. Pack-years = (cigarettes per day/20 cigarettes per pack) × duration of smoking (years). Categories are not mutually exclusive. Chest congestion, discomfort, tightness, pain or wheeze. Scale: 0–100; higher scores are better; t= 0.91: COPD versus non-COPD, NS, P= 0.37. Scale: 0–100; higher scores are better t= 0.28: COPD versus non-COPD, NS, P= 0.78. Scale: 0–100; higher scores are worse t= 1.49: COPD versus non-COPD, NS, P= 1.4. exertion, low energy, sleeping problems such as waking up at sputum/phlegm (100%); tight, wheezy or noisy chest (90%); night feeling short of breath); (5) impact of breathing-related slowing down (40%); fatigue (50%); and sleep problems (40%). No problems on daily life (e.g., slowing down or stopping owing to qualitative differences were found between data provided by the breathlessness, unable to complete daily chores, unable to keep three subjects with evidence of airway obstruction and other up with others); and (6) the attribution of symptoms or participants. Sample quotes for each theme are shown in Table 4. experiences (e.g., breathless, being tired or slowing down Candidate item content is shown in Table 5. attributed to age or weight; cough attributed to smoking or Electronic and manual PEF devices were rated as ‘easy’ or ‘very smoke exposure). easy’ to use by participants (96%; 94%) and clinical site staff (80%; Themes were consistent across COPD and non-COPD partici- 84%). PEF values by device and group are shown in Table 6. pants, with some cross-group variation in emphasis within each With the data analysed, a draft questionnaire with 48 candidate theme. Spontaneous symptom reporting rates were generally items was constructed and subjected to cognitive interviewing in lowest for Group 3 (non-COPD ⩽ 2 risk factors); rates for Group 4 a separate sample of 27 subjects. The instructions and item pool (non-COPD, ⩾ 4 risk factors) were similar to the COPD groups on were easily understood and appropriately interpreted by the npj Primary Care Respiratory Medicine (2015) 15024 © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited COPD screening qualitative study NK Leidy et al Table 4. Key themes and representative quotes Exposure: 3: 004-102 All my family smokes. 2: 002-110 I worked in a tobacco warehouse for about a year…I was a…dancer for 13 years, barroom smoke. 2: 001-101 Working with material, fuzzy material and breathing it in. 1: 002-101 Around different chemicals, paint, plastic, you name it and we did it all. Personal and family history: 2: 001-139 J My parents were both smokers…my mother was 92 when she was diagnosed with COPD and my father died of emphysema. J When it takes that long to recover from 1, when you have like 2 or 3 in the course of a 3 or 4-month winter…it ends up you’re feeling—you’re feeling 1: 001-145 crummy for 75% of the time. 2: 006-104 J I’ve gotten sinus infections in the spring and the fall, I bet, for the last 10 years…and I think like 5 times it has ended up as pneumonia. ;I’ve had 3: 004-125 pneumonia … maybe 7, 8 times in my life. Recent history: 2: 001-123 J The smell of—of detergents and, uh, lovely perfumes do affect, um, my deep breathing. J If I’m going to be around dust or chemicals or cigarette smoke…I have to wear a mask because if not, it will be like, uh, I will, uh, start feeling the 3: 004-127 tightness in midst of—at first sign, it’s like my chest will start tightening up. 4: 003-131 J You’re trying to breathe and it hurts, and it hurts and you have pain and then it hurts and …then go to the hospital for it—it’s the lungs. Symptoms—respiratory and non-respiratory: 2: 002-110 Just feels like you've got like something like a ton of bricks just sitting on your chest. I wouldn't have any trouble breathing hardly, but I'd just be running short on breath. Like I could walk a country mile, like a stroll, but I can't go up a flight 1: 002-103 of stairs if I get in a hurry. 2: 002-106 I walk up the driveway to my car, and--I'm really tired after that. I feel me [panting] breathing…you kind of feel tired all the time. Impact: 2: 001-141 I’d go out to lunch with…people from my office… I’d really have to kind of push myself to keep up with them ….had to work to keep up. 1: 002-113 I have a hard time…climbing stairs, and I've got to take it slow. I have to walk slowly. 4: 002-113 Walk up and down them halls, and sometimes I just feel like okay, wait, and I stop for a minute. Attribution: 2: 002-109 I've got a smoker's cough because I smoke. 1: 002-101 I noticed I was starting to slow down with my breathing, but it actually got worse after I started having all this other health issues. Abbreviation: COPD, chronic obstructive pulmonary disease. Superscripts show subgroup membership and patient ID. Table 5. Key themes and candidate content Theme Candidate content Exposure Smoking (current, history) Second-hand smoke ‘Dirty’ air Personal and family history Family smoking history Relatives with COPD, lung cancer, asthma Personal history of recurrent chest infections/colds Recent history Environmental triggers affect breathing Colds, acute bronchitis Clinic visits for or with breathing-related problems Hospitalisations for or with breathing-related problems Missed school or work days owing to breathing-related problems Symptoms Respiratory: dyspnoea, cough, sputum, chest congestion, wheezy/noisy breathing, chest tightness, chest heavy Non-respiratory: fatigue, feeling tired, lack of energy, sleep difficulties, slowing down Impact Activity limitations—stairs, steps, walking quickly Frequent stopping, keeping up with others Attribution Symptom attribution to smoking, age, weight or other health conditions Abbreviation: COPD, chronic obstructive pulmonary disease. © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited npj Primary Care Respiratory Medicine (2015) 15024 COPD screening qualitative study NK Leidy et al identifying undiagnosed COPD. Cough, phlegm, dyspnoea and Table 6. Mean (s.d.) peak flow by device type and group 21–23 wheeze, as well as history of chest infections, breathing- 23,24 related disability or hospitalisations, for example, were Device Total (N = 50) COPD Risk, no COPD broached and characterised by these participants. In addition, (Groups 1 & 2) (Groups 3 & 4) (N = 20) (N = 30) however, subjects described chest symptoms, including conges- tion, noisy or tight, as well as feelings of fatigue and sleep Electronic 362 (158) 274 (124) 424 (151) difficulties. Participant descriptions of family history of respiratory- Manual 315 (131) 249 (104) 358 (130) related problems, symptoms, activity limitations and acute a a Difference 43.79 (60.76) 24.89 (38.69) 57.09 (70.05) b c d respiratory illnesses offer new insight into candidate items for t= 4.89 t = 2.80 t= 4.23 identifying undiagnosed cases of clinically significant COPD. Abbreviation: ANOVA, analysis of variance; COPD, chronic obstructive Smokers and non-smokers were included to facilitate the use of pulmonary disease. the questionnaire in both groups. There is evidence to suggest ANOVA testing group effects showed no difference (F= 3.29, P= 0.076). that one-fourth to one-third of all COPD cases are non-smokers, Paired t-test,Po0.0001. c with country-to-country variability. The international study of Paired t-test, Po0.05. Lamprecht et al. found that 81% of never smokers with Paired t-test, Po0.001. moderate-to-severe airway obstruction were undiagnosed. The study of Bednarek et al. in Poland suggested that detection of COPD is reduced by 26% when a ‘smokers only’ criterion is used, subjects; several adjustments were made to enhance clarity. PEF whereas in the Third US NHANES database, ‘never smokers’ results were similar to those found in the elicitation sample (see accounted for 23% of airway obstruction cases, 69% of whom had Online Supplementary). 43 no prior respiratory diagnosis. Sample clinical characteristics provide further qualitative insight into the challenges associated with variable selection for case DISCUSSION identification. Descriptively, the frequency of breathing-related Main findings symptoms (e.g., cough, shortness of breath) and other risk factors This qualitative study is part of a larger multi-method approach to (e.g., history of asthma, family history of breathing problems) were develop a screening method for identifying patients with similar across groups. The COPD group reported more breathing undiagnosed, clinically significant COPD in primary care. Six key events over the past year (e.g., cold, chest infection). Although themes were identified; candidate items were developed, using there were no significant differences in health status between the words and phrases easily understood by people in the target two groups, the descriptively higher COPD Assessment Test scores population. Although participants and clinical staff rated the two for COPD subjects suggest a trend toward poorer health in areas PEF devices easy to use, values produced by the electronic device specific to COPD, with the mean between-group difference were significantly higher than those provided by the manual exceeding the proposed two-point minimum clinically important device. difference. These exploratory results suggest that a small set of targeted questions may be more effective than a large number of general health questions for identifying people with COPD. Strengths and limitations of this study This is among the first known uses of qualitative data to inform the development of a screening tool for COPD case identification Implications for future research, policy and practice in a clinical setting. The study included men and women with As part of our screening tool development, we will be testing the varied COPD experiences, risk factors and education. The fact that added value of including PEF to increase sensitivity and specificity. all subjects were from the United States and most were white To facilitate and optimise utilisation of PEF as part of the screening (70%) and not Hispanic or Latino (92%) is a limitation of the study. process, we evaluated the usability and comparability of electronic In addition, although a larger number of subjects with undiag- and manual devices. Most patients and clinic staff rated the nosed COPD would have been ideal, a study design that explicitly devices easy or very easy to use, suggesting that either might be included screening and identifying subjects with undiagnosed suitable. However, differences in PEF values indicate a need for clinically significant COPD (using methods not designed for this standardisation to simplify the process by providing a single purpose) would have been cost-prohibitive. The fact that all threshold for interpretation. With cost and availability in mind, the moderators and interviewers were female may have influenced manual PEF device will be tested further during the next phase of participant responses, although staff were experienced and screening tool development. The questionnaire’s sensitivity and trained to encourage discussion and minimise bias. specificity will be optimised independently of PEF, and thus those preferring to use FEV or PEF captured through an electronic/ digital device would be free to do so, applying their preferred Interpretation of findings in relation to previously published work threshold for follow-up evaluation. The attribution theme offers insight into why certain symptoms are not reported or recognised as indicators of COPD. Participants Conclusions who smoked often attributed their cough to smoking; others attributed slowing down, feeling tired or becoming breathless This qualitative study is part of a multi-method approach for with exertion to ageing, weight or other health issues. These developing a new screening method for identifying primary care findings are consistent with descriptions of barriers to diagnosis; patients who may have undiagnosed, clinically significant COPD. quantitative evidence that symptom-based diagnosis of COPD in Six themes were identified: exposure, personal and family health, primary care settings is unreliable, particularly if patients are recent history of respiratory events, respiratory and non- overweight; and qualitative research suggesting that people respiratory symptoms, impact, and attribution. A pool of 48 minimise and negotiate the importance of symptoms and need to candidate items was developed and revised based on cognitive acknowledge ‘there must be something wrong’ as part of the interview results. Items will be tested and eliminated during the diagnostic process. next phase of instrument development, with the intent of finding Most of the respiratory symptoms identified in this study were the best, smallest set of questions that, together with PEF, can consistent with existing, symptom-based questionnaires for identify patients in need of diagnostic evaluation for COPD. npj Primary Care Respiratory Medicine (2015) 15024 © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited COPD screening qualitative study NK Leidy et al medical presentations in COPD or IPF for the American College of Chest Physicians, ACKNOWLEDGEMENTS the American Thoracic Society, CME Incite, Center for Health Care Education, Inova The authors thank Sarah Clifford for her comments during protocol development and Health Systems, MedScape, Miller Medical, National Association for Continuing Kathryn Miller for text editing and formatting the protocol and manuscript. Education, Paradigm, Peer Voice, Projects in Knowledge, Spectrum Health System, St John’s Hospital, St Mary’s Hospital, University of Illinois Chicago, University of Texas HIGH-RISK-COPD SCREENING STUDY GROUP Southwestern, University of Virginia, UpToDate and Wayne State University. FM has Rebecca Copeland, University of Kentucky; Tim Dorius, University of Nebraska participated in data safety monitoring committees sponsored by GSK and Stromedix. Medical Center; David Hengerer, Evidera; Patricia Jellen, New York Presbyterian He has aided with FDA presentations sponsored by Boehringer Ingelheim, GSK and Hospital; Marge Kurland, Olmsted Medical Center; Karen Malley, Evidera; Jason Ikaria. He has spoken on COPD for Bayer, Forest, GSK and Nycomed/Takeda. He has Shiffermiller, University of Nebraska Medical Center; Christina Schnell, National Jewish participated in advisory teleconferences sponsored by the American Institute for Health; Lori Silveira, National Jewish Health; Sonja Stringer, Evidera; Deb Sumnick, Research, Axon, Grey Healthcare, Johnson & Johnson and Merion. He has received University of Nebraska; Randel Plant, COPD Foundation; Jennifer Underwood, book royalties from Informa. National Jewish Health; Beth Whippo, New York Presbyterian Hospital. CONTRIBUTIONS FUNDING Each named author participated in the study design and data analyses and Funding for this work was provided by the National Heart, Lung, and Blood Institute interpretation. BPY, DMM, BMT, RGB, SIR, JFH, MKH, CAM, RPB and FM also NHLBI: R01 HL 114055. Additional support was provided by NHLBI:R01 HL089856 and participated in subject recruitment and data collection activities; LTM, KK and AWS R01 HL089897. served as focus group moderators, field note takers and interviewers. NKL, EDB, KK, AWS and LTM contributed to data management, analyses and interpretation. All the authors participated in manuscript development, review and/or editing. NKL, DMM and FM serve as co-investigators of the grant and, together with the co-authors, REFERENCES attest to the accuracy of the information contained in this manuscript. 1 Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med 2006; 3:e442. 2 Bednarek M, Maciejewski J, Wozniak M, Kuca P, Zielinski J. Prevalence, severity COMPETING INTERESTS and underdiagnosis of COPD in the primary care setting. Thorax 2008; 63: 402–407. 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Prim Care Respir J 2011; 20: analysis. Lancet Respir Med 2014; 2: 195–203. 184–189. 31 Jithoo A, Enright PL, Burney P, Buist AS, Bateman ED, Tan WC et al. Case-finding options for COPD: results from the Burden of Obstructive Lung Disease study. Eur This work is licensed under a Creative Commons Attribution- Respir J 2013; 41: 548–555. NonCommercial-NoDerivatives 4.0 International License. The images 32 Nelson SB, LaVange LM, Nie Y, Walsh JW, Enright PL, Martinez FJ et al. or other third party material in this article are included in the article’s Creative Commons Questionnaires and pocket spirometers provide an alternative approach for COPD license, unless indicated otherwise in the credit line; if the material is not included under screening in the general population. Chest 2012; 142: 358–366. the Creative Commons license, users will need to obtain permission from the license 33 Martinez FJ. NHLBI Workshop: A Case-finding Strategy for Moderate-to-Severe holder to reproduce the material. To view a copy of this license, visit http:// COPD in the United States Executive Summary. November 2009. http:// creativecommons.org/licenses/by-nc-nd/4.0/ Supplementary Information accompanies the paper on the npj Primary Care Respiratory Medicine website (http://www.nature.com/npjpcrm) npj Primary Care Respiratory Medicine (2015) 15024 © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited

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npj Primary Care Respiratory MedicineSpringer Journals

Published: Apr 16, 2015

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