Early Diagnosis and Treatment of COPD and Asthma - A Randomized, Controlled Trial.

BACKGROUND: Many persons with chronic obstructive pulmonary disease (COPD) or asthma have not received a diagnosis, so their respiratory symptoms remain largely untreated. METHODS: We used a case-finding method to identify adults in the community with respiratory symptoms without diagnosed lung disease. Participants who were found to have undiagnosed COPD or asthma on spirometry were enrolled in a multicenter, randomized, controlled trial to determine whether early diagnosis and treatment reduces health care utilization for respiratory illness and improves health outcomes. Participants were assigned to receive the intervention (evaluation by a pulmonologist and an asthma-COPD educator who were instructed to initiate guideline-based care) or usual care by their primary care practitioner. The primary outcome was the annualized rate of participant-initiated health care utilization for respiratory illness. Secondary outcomes included changes from baseline to 1 year in disease-specific quality of life, as assessed with the St. George Respiratory Questionnaire (SGRQ; scores range from 0 to 100, with lower scores indicating better health status); symptom burden, as assessed with the COPD Assessment Test (CAT; scores range from 0 to 40, with lower scores indicating better health status); and forced expiratory volume in 1 second (FEV1). RESULTS: Of 38,353 persons interviewed, 595 were found to have undiagnosed COPD or asthma and 508 underwent randomization: 253 were assigned to the intervention group and 255 to the usual-care group. The annualized rate of a primary-outcome event was lower in the intervention group than in the usual-care group (0.53 vs. 1.12 events per person-year; incidence rate ratio, 0.48; 95% confidence interval [CI], 0.36 to 0.63; P<0.001). At 12 months, the SGRQ score was lower than the baseline score by 10.2 points in the intervention group and by 6.8 points in the usual-care group (difference, -3.5 points; 95% CI, -6.0 to -0.9), and the CAT score was lower than the baseline score by 3.8 points and 2.6 points, respectively (difference, -1.3 points; 95% CI, -2.4 to -0.1). The FEV1 increased by 119 ml in the intervention group and by 22 ml in the usual-care group (difference, 94 ml; 95% CI, 50 to 138). The incidence of adverse events was similar in the trial groups. CONCLUSIONS: In this trial in which a strategy was used to identify adults in the community with undiagnosed asthma or COPD, those who received pulmonologist-directed treatment had less subsequent health care utilization for respiratory illness than those who received usual care. (Funded by Canadian Institutes of Health Research; UCAP ClinicalTrials.gov number, NCT03148210.).

Impact of Undiagnosed Chronic Obstructive Pulmonary Disease and Asthma on Symptoms, Quality of Life, Healthcare Use, and Work Productivity.

Rationale: A significant proportion of individuals with chronic obstructive pulmonary disease (COPD) and asthma remain undiagnosed. Objectives: The objective of this study was to evaluate symptoms, quality of life, healthcare use, and work productivity in subjects with undiagnosed COPD or asthma compared with those previously diagnosed, as well as healthy control subjects. Methods: This multicenter population-based case-finding study randomly recruited adults with respiratory symptoms who had no previous history of diagnosed lung disease from 17 Canadian centers using random digit dialing. Participants who exceeded symptom thresholds on the Asthma Screening Questionnaire or the COPD Diagnostic Questionnaire underwent pre- and post-bronchodilator spirometry to determine if they met diagnostic criteria for COPD or asthma. Two control groups, a healthy group without respiratory symptoms and a symptomatic group with previously diagnosed COPD or asthma, were similarly recruited. Measurements and Main Results: A total of 26,905 symptomatic individuals were interviewed, and 4,272 subjects were eligible. Of these, 2,857 completed pre- and post-bronchodilator spirometry, and 595 (21%) met diagnostic criteria for COPD or asthma. Individuals with undiagnosed COPD or asthma reported greater impact of symptoms on health status and daily activities, worse disease-specific and general quality of life, greater healthcare use, and poorer work productivity than healthy control subjects. Individuals with undiagnosed asthma had symptoms, quality of life, and healthcare use burden similar to those of individuals with previously diagnosed asthma, whereas subjects with undiagnosed COPD were less disabled than those with previously diagnosed COPD. Conclusions: Undiagnosed COPD or asthma imposes important, unmeasured burdens on the healthcare system and is associated with poor health status and negative effects on work productivity.

Patient and physician factors associated with symptomatic undiagnosed asthma or COPD.

BACKGROUND: It remains unclear why some symptomatic individuals with asthma or COPD remain undiagnosed. Here, we compare patient and physician characteristics between symptomatic individuals with obstructive lung disease (OLD) who are undiagnosed and individuals with physician-diagnosed OLD. METHODS: Using random-digit dialling and population-based case finding, we recruited 451 participants with symptomatic undiagnosed OLD and 205 symptomatic control participants with physician-diagnosed OLD. Data on symptoms, quality of life and healthcare utilisation were analysed. We surveyed family physicians of participants in both groups to elucidate differences in physician practices that could contribute to undiagnosed OLD. RESULTS: Participants with undiagnosed OLD had lower mean pre-bronchodilator forced expiratory volume in 1 s percentage predicted compared with those who were diagnosed (75.2% versus 80.8%; OR 0.975, 95% CI 0.963-0.987). They reported greater psychosocial impacts due to symptoms and worse energy and fatigue than those with diagnosed OLD. Undiagnosed OLD was more common in participants whose family physicians were practising for >15 years and in those whose physicians reported that they were likely to prescribe respiratory medications without doing spirometry. Undiagnosed OLD was more common among participants who had never undergone spirometry (OR 10.83, 95% CI 6.18-18.98) or who were never referred to a specialist (OR 5.92, 95% CI 3.58-9.77). Undiagnosed OLD was less common among participants who had required emergency department care (OR 0.44, 95% CI 0.20-0.97). CONCLUSIONS: Individuals with symptomatic undiagnosed OLD have worse pre-bronchodilator lung function and present with greater psychosocial impacts on quality of life compared with their diagnosed counterparts. They were less likely to have received appropriate investigations and specialist referral for their respiratory symptoms.

Derivation and validation of the UCAP-Q case-finding questionnaire to detect undiagnosed asthma and COPD.

BACKGROUND: Many people with asthma and COPD remain undiagnosed. We developed and validated a new case-finding questionnaire to identify symptomatic adults with undiagnosed obstructive lung disease. METHODS: Adults in the community with no prior history of physician-diagnosed lung disease who self-reported respiratory symptoms were contacted via random-digit dialling. Pre- and post-bronchodilator spirometry was used to confirm asthma or COPD. Predictive questions were selected using multinomial logistic regression with backward elimination. Questionnaire performance was assessed using sensitivity, predictive values and area under the receiver operating characteristic curve (AUC). The questionnaire was assessed for test-retest reliability, acceptability and readability. External validation was prospectively conducted in an independent sample and predictive performance re-evaluated. RESULTS: A 13-item Undiagnosed COPD and Asthma Population Questionnaire (UCAP-Q) case-finding questionnaire to predict undiagnosed asthma or COPD was developed. The most appropriate risk cut-off was determined to be 6% for either disease. Applied to the derivation sample (n=1615), the questionnaire yielded a sensitivity of 92% for asthma and 97% for COPD; specificity of 17%; and an AUC of 0.69 (95% CI 0.64-0.74) for asthma and 0.82 (95% CI 0.78-0.86) for COPD. Prospective validation using an independent sample (n=471) showed sensitivities of 93% and 92% for asthma and COPD, respectively; specificity of 19%; with AUCs of 0.70 (95% CI 0.62-0.79) for asthma and 0.81 (95% CI 0.74-0.87) for COPD. AUCs for UCAP-Q were higher compared to AUCs for currently recommended case-finding questionnaires for asthma or COPD. CONCLUSIONS: The UCAP-Q demonstrated high sensitivities and AUCs for identifying undiagnosed asthma or COPD. A web-based calculator allows for easy calculation of risk probabilities for each disease.

Cost-effectiveness of integrated disease management for high risk, exacerbation prone, patients with chronic obstructive pulmonary disease in a primary care setting.

BACKGROUND: We evaluate the cost-effectiveness of the 'Best Care' integrated disease management (IDM) program for high risk, exacerbation prone, patients with chronic obstructive pulmonary disease (COPD) compared to usual care (UC) within a primary care setting from the perspective of a publicly funded health system (i.e., Ontario, Canada). METHODS: We conducted a model-based, cost-utility analysis using a Markov model with expected values of costs and outcomes derived from a Monte-Carlo Simulation with 5000 replications. The target population included patients started in GOLD II with a starting age of 68 years in the trial-based analysis. Key input parameters were based on a randomized control trial of 143 patients (i.e., UC (n = 73) versus IDM program (n = 70)). Results were shown as incremental cost per quality-adjusted life year (QALY) gained. RESULTS: The IDM program for high risk, exacerbation prone, patients is dominant in comparison with the UC group. After one year, the IDM program demonstrated cost savings and improved QALYs (i.e., UC was dominated by IDM) with a positive net-benefit of $5360 (95% CI: ($5175, $5546) based on a willingness to pay of $50,000 (CAN) per QALY. CONCLUSIONS: This study demonstrates that the IDM intervention for patients with COPD in a primary care setting is cost-effective in comparison to the standard of care. By demonstrating the cost-effectiveness of IDM, we confirm that investment in the delivery of evidence based best practices in primary care delivers better patient outcomes at a lower cost than UC.

Evaluating the implementation of a chronic obstructive pulmonary disease management program using the Consolidated Framework for Implementation Research: a case study.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a prevalent chronic disease that requires comprehensive approaches to manage; it accounts for a significant portion of Canada's annual healthcare spending. Interprofessional teams are effective at providing chronic disease management that meets the needs of patients. As part of an ongoing initiative, a COPD management program, the Best Care COPD program was implemented in a primary care setting. The objectives of this research were to determine site-specific factors facilitating or impeding the implementation of a COPD program in a new setting, while evaluating the implementation strategy used. METHODS: A qualitative case study was conducted using interviews, focus groups, document analysis, and site visits. Data were deductively analyzed using the Consolidated Framework for Implementation Research (CFIR) to assess the impact of each of its constructs on Best Care COPD program implementation at this site. RESULTS: Eleven CFIR constructs were determined to meaningfully affect implementation. Five were identified as the most influential in the implementation process. Cosmopolitanism (partnerships with other organizations), networks and communication (amongst program providers), engaging (key individuals to participate in program implementation), design quality and packaging (of the program), and reflecting and evaluating (throughout the implementation process). A peer-to-peer implementation strategy included training of registered respiratory therapists (RRT) as certified respiratory educators and the establishment of a communication network among RRTs to discuss experiences, collectively solve problems, and connect with the program lead. CONCLUSIONS: This study provides a practical example of the various factors that facilitated the implementation of the Best Care COPD program. It also demonstrates the potential of using a peer-to-peer implementation strategy. Focusing on these factors will be useful for informing the continued spread and success of the Best Care COPD program and future implementation of other chronic care programs.

Estimating the Health and Economic Impact of Improved Management in Prevalent Chronic Obstructive Pulmonary Disease Populations in England, Germany, Canada, and Japan: A Modelling Study.

Introduction: COPD is a leading cause of morbidity and mortality globally. Management is complex and costly. Although international quality standards for diagnosis and management exist, opportunities remain to improve outcomes, especially in reducing avoidable hospitalisations. Objective: To estimate the potential health and economic impact of improved adherence to guideline-recommended care for prevalent, on-treatment COPD populations in four high-income settings. Methods: A disease simulation model was developed to evaluate the impact of theoretical improvements to COPD management, comparing outcomes for usual care and policy scenarios for interventions that reduce avoidable hospitalisations: 1) increased attendance (50% vs 31-38%) of early follow-up review after severe exacerbation hospitalisation; 2) increased access (30% vs 5-10%) to an integrated disease management (IDM) programme that provides guideline adherent care. Results: For cohorts of 100,000 patients, Policy 1 yielded additional life years (England: 523; Germany: 759; Canada: 1316; Japan: 512) and lifetime cost savings (-£2.89 million; -€6.58 million; -$40.08 million; -¥735.58 million). For Policy 2, additional life years (2299; 3619; 3656) and higher lifetime total costs (£38.15 million; €35.58 million; ¥1091.53 million) were estimated in England, Germany and Japan, and additional life years (4299) and cost savings (-$20.52 million) in Canada. Scenarios found that the cost impact depended on the modelled intervention effect size. Conclusion: Interventions that reduce avoidable hospitalisations are estimated to improve survival and may generate cost savings. This study provides evidence on the theoretical impact of policies to improve COPD care and highlights priority areas for further research to support evidence-based policy decisions.

Disease burden in individuals with symptomatic undiagnosed asthma or COPD.

BACKGROUND: The actual burden of COPD and asthma may be much higher than appreciated, since a large proportion of individuals are not diagnosed. Our study objective was to compare health care utilization, burden of symptoms and quality of life in subjects with self-reported respiratory symptoms who were subsequently found to have undiagnosed airflow obstruction compared to those having no airflow obstruction. METHODS: This cross-sectional case-finding study used data from the Undiagnosed COPD and Asthma Population (UCAP) study. Adult subjects with respiratory symptoms who had no history of diagnosed lung disease were recruited in a two-step case-finding process using random digit-dialling of land lines and cell phones located within a 90-min radius of 16 Canadian study sites. Participants were assessed for COPD, asthma or no airflow obstruction using pre- and post-bronchodilator spirometry based on American Thoracic Society diagnostic criteria. RESULTS: 1660 participants were recruited, of these 1615 had adequate spirometry and 331 (20.5%) subjects met spirometry criteria for undiagnosed asthma or COPD. Subjects with undiagnosed asthma or COPD had increased respiratory symptoms as assessed by the COPD Assessment Test (CAT), and higher St. George's Respiratory Questionnaire (SGRQ) scores indicating worse health-related quality of life, compared to subjects with no airflow obstruction. No between-group differences were found in health care utilization or work or school absenteeism. CONCLUSION: Undiagnosed asthma and COPD are common in Canadian adults experiencing breathing problems and are associated with a greater burden of symptoms and poorer health-related quality of life. These results suggest that patients may benefit from early identification and treatment of undiagnosed asthma and COPD.

Comparison of asthma control criteria: importance of spirometry.

AIMS: To compare the measurements of asthma control using Canadian Thoracic Society (CTS) Asthma Management Consensus Summary and Global Initiative for Asthma (GINA) guidelines composite indices with and without spirometry. METHODS: Asthma control parameters were extracted from electronic medical records (EMRs) of patients ≥6 years old at two primary care sites. Asthma control ratings calculated according to CTS and GINA criteria were compared. RESULTS: Data were available from 113 visits by 93 patients, aged 6-85 years (38.7 ± 24.8; mean ± SD). The proportion of visits at which individuals' asthma was completely controlled was 22.1% for CTS symptoms only and 9.7% for CTS with spirometry (p < .01); and 17.7% versus 14.1% for GINA symptoms only versus symptoms with spirometry (p = .125). CONCLUSIONS: Asthma control ratings using GINA and CTS criteria are discordant in more than half of the patients deemed "in control" by at least one scale. Differences in the spirometry criterion threshold are primarily responsible for this discordance. Failure to include spirometry as part of the control index consistently overestimates asthma control and may underestimate future risk of exacerbations.

Integrated Disease Management for Chronic Obstructive Pulmonary Disease in Primary Care, from the Controlled Trial to Clinical Program: A Cohort Study.

PURPOSE: Integrated disease management (IDM) for COPD in primary care has been primarily investigated under clinical trial conditions. We previously published a randomized controlled trial (RCT) where the IDM intervention improved quality of life (QoL) and exacerbation-related outcomes. In this study, we assess the same IDM intervention in a real-world evaluation and identify patient characteristics associated with improved outcomes. METHODS: This historical cohort study included patients enrolled for 12 (±3 months) in the Best Care COPD IDM program. The main outcome was a ≥3 point improvement in COPD assessment test (CAT). Secondary outcomes were COPD exacerbations requiring antibiotics and/or prednisone, unscheduled physician visits, emergency department visits and hospitalizations. RESULTS: Data for 571 patients (all patients) were included, 158 met the reference RCT eligibility (RCT matched). Improved QoL was observed in 43% (95% CI:38.9,47.2) of all patients, 47% (95% CI:39.5,55.6) of RCT matched vs 92% (95% CI:79.2,95.1) in the reference RCT intervention arm (n=72). Reductions (12 months IDM vs prior year) were observed in the proportion of patients experiencing exacerbation-related events (all patients): antibiotics/prednisone (-9.0%,95% CI:-13.9,-3.9); unscheduled physician (-33.1%,95% CI:-38.2,-27.9); emergency department (-9.6%,95% CI:-13.5,-5); and hospitalizations (-6.8%,95% CI:-10.0,-3.7). For the RCT matched group all reductions were comparable to the reference RCT intervention arm. The strongest predictors of improved QoL were baseline CAT, CAT≥20 vs CAT<10 (OR 15.6,95% CI:7.91,30.83), GOLD group B (OR 6.4,95% CI:3.42,11.85) and D (OR 5.64,95% CI:2.80,11.37) vs GOLD group A. Patients with prior antibiotic/prednisone use, FEV1 <30% predicted and GOLD group D were less likely to have no urgent health service utilization (OR 0.5,95% CI:0.30,0.68), (OR 0.2,95% CI:0.07,0.78) and (OR 0.3,95% CI:0.14,0.51), respectively. CONCLUSION: Best Care COPD improved QoL and reduced exacerbation-related outcomes in a manner directionally similar to the RCT from which it emanated. Baseline QoL, exacerbation history, and GOLD category were identified as possible predictors of IDM impact and will inform future program development and resource allocation.

The impact of integrated disease management in high-risk COPD patients in primary care.

Patients with chronic obstructive pulmonary disease (COPD) have a reduced quality of life (QoL) and exacerbations that drive health service utilization (HSU). A majority of patients with COPD are managed in primary care. Our objective was to evaluate an integrated disease management, self-management, and structured follow-up intervention (IDM) for high-risk patients with COPD in primary care. This was a one-year multi-center randomized controlled trial. High-risk, exacerbation-prone COPD patients were randomized to IDM provided by a certified respiratory educator and physician, or usual physician care. IDM received case management, self-management education, and skills training. The primary outcome, COPD-related QoL, was measured using the COPD Assessment Test (CAT). Of 180 patients randomized from 8 sites, 81.1% completed the study. Patients were 53.6% women, mean age 68.2 years, post-bronchodilator FEV1 52.8% predicted, and 77.4% were Global Initiative for Obstructive Lung Disease Stage D. QoL-CAT scores improved in IDM patients, 22.6 to 14.8, and worsened in usual care, 19.3 to 22.0, adjusted difference 9.3 (p < 0.001). Secondary outcomes including the Clinical COPD Questionnaire, Bristol Knowledge Questionnaire, and FEV1 demonstrated differential improvements in favor of IDM of 1.29 (p < 0.001), 29.6% (p < 0.001), and 100 mL, respectively (p = 0.016). Compared to usual care, significantly fewer IDM patients had a severe exacerbation, -48.9% (p < 0.001), required an urgent primary care visit for COPD, -30.2% (p < 0.001), or had an emergency department visit, -23.6% (p = 0.001). We conclude that IDM self-management and structured follow-up substantially improved QoL, knowledge, FEV1, reduced severe exacerbations, and HSU, in a high-risk primary care COPD population. Clinicaltrials.gov NCT02343055.

Clinical characteristics of women with menstrual-linked asthma.

BACKGROUND: Menstrual-linked asthma (MLA) is described in pre-menopausal women who experience a deterioration of asthma control peri-menstrually. The clinical characteristics of MLA remain incompletely defined. Our objective was to define the characteristics of MLA in a large female asthma cohort. METHODS: Cross-sectional population survey. A comprehensive health questionnaire that included questions about MLA was administered to 1260 consecutive female asthma patients aged 12-55 years. Univariate and multivariate analyses were completed. RESULTS: The survey response rate was 43% (540/1260). The prevalence of self-reported MLA was 11% (60/540). Univariate: women with MLA compared to women without MLA had more urgent/emergent asthma-related healthcare visits/year, 6.18 (SD = ± 6.67) vs. 4.71 (SD = ± 5.91) (p=0.033), more emergency room visits, 1.50 (SD = ± 3.57) vs. 0.88 (SD = ± 2.27) (p=0.035), higher asthma-related absenteeism, 33/60 (57%) vs. 170/471 (37%) (p=0.003), and used almost twice the number of B(2)-agonist rescue doses/day, 1.13 (SD = ± 1.70) vs. 0.68 (SD = ± 1.32) (p=0.015). Multivariate: statistical significance was retained for absenteeism (p=0.016) and B(2)-agonist use (p=0.007) but lost for urgent healthcare visits (p=0.150) and emergency room visits (p=0.068). CONCLUSIONS: Self-reported MLA is common. Women with MLA in our population had a greater frequency of urgent healthcare visits, a higher rate of absenteeism, and used significantly more B(2)-agonist rescue than women without MLA. The association of increased health services use was not confirmed on multivariate analysis indicating that baseline characteristics associated with MLA in our population affected this outcome. MLA should be considered by healthcare providers when developing an asthma management plan.

Spirometry in primary care: an analysis of spirometery test quality in a regional primary care asthma program.

BACKGROUND: Primary care office spirometry can improve access to testing and concordance between clinical practice and asthma guidelines. Compliance with test quality standards is essential to implementation. OBJECTIVE: To evaluate the quality of spirometry performed onsite in a regional primary care asthma program (RAP) by health care professionals with limited training. METHODS: Asthma educators were trained to perform spirometry during two 2 h workshops and supervised during up to six patient encounters. Quality was analyzed using American Thoracic Society (ATS) 1994 and ATS/European Respiratory Society (ERS) 2003 (ATS/ERS) standards. These results were compared with two regional reference sites: a primary care group practice (Family Medical Centre [FMC], Windsor, Ontario) and a teaching hospital pulmonary function laboratory (London Health Sciences Centre [LHSC], London, Ontario). RESULTS: A total of 12,815 flow-volume loops (FVL) were evaluated: RAP - 1606 FVL in 472 patient sessions; reference sites - FMC 4013 FVL in 573 sessions; and LHSC - 7196 in 1151 sessions. RAP: There were three acceptable FVL in 392 of 472 (83%) sessions, two reproducible FVL according to ATS criteria in 428 of 469 (91%) sessions, and 395 of 469 (84%) according to ATS/ERS criteria. All quality criteria - minimum of three acceptable and two reproducible FVL according to ATS criteria in 361 of 472 (77%) sessions and according to ATS/ERS criteria in 337 of 472 (71%) sessions. RAP met ATS criteria more often than the FMC (388 of 573 [68%]); however, less often than LHSC (1050 of 1151 [91%]; P<0.001). CONCLUSIONS: Health care providers with limited training and experience operating within a simple quality program achieved ATS/ERS quality spirometry in the majority of sessions in a primary care setting. The quality performance approached pulmonary function laboratory standards.