Discriminative Accuracy of the CAPTURE Tool for Identifying Chronic Obstructive Pulmonary Disease in US Primary Care Settings.

Importance: Chronic obstructive pulmonary disease (COPD) is underdiagnosed in primary care. Objective: To evaluate the operating characteristics of the CAPTURE (COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk) screening tool for identifying US primary care patients with undiagnosed, clinically significant COPD. Design, Setting, and Participants: In this cross-sectional study, 4679 primary care patients aged 45 years to 80 years without a prior COPD diagnosis were enrolled by 7 primary care practice-based research networks across the US between October 12, 2018, and April 1, 2022. The CAPTURE questionnaire responses, peak expiratory flow rate, COPD Assessment Test scores, history of acute respiratory illnesses, demographics, and spirometry results were collected. Exposure: Undiagnosed COPD. Main Outcomes and Measures: The primary outcome was the CAPTURE tool's sensitivity and specificity for identifying patients with undiagnosed, clinically significant COPD. The secondary outcomes included the analyses of varying thresholds for defining a positive screening result for clinically significant COPD. A positive screening result was defined as (1) a CAPTURE questionnaire score of 5 or 6 or (2) a questionnaire score of 2, 3, or 4 together with a peak expiratory flow rate of less than 250 L/min for females or less than 350 L/min for males. Clinically significant COPD was defined as spirometry-defined COPD (postbronchodilator ratio of forced expiratory volume in the first second of expiration [FEV1] to forced vital capacity [FEV1:FVC] <0.70 or prebronchodilator FEV1:FVC <0.65 if postbronchodilator spirometry was not completed) combined with either an FEV1 less than 60% of the predicted value or a self-reported history of an acute respiratory illness within the past 12 months. Results: Of the 4325 patients who had adequate data for analysis (63.0% were women; the mean age was 61.6 years [SD, 9.1 years]), 44.6% had ever smoked cigarettes, 18.3% reported a prior asthma diagnosis or use of inhaled respiratory medications, 13.2% currently smoked cigarettes, and 10.0% reported at least 1 cardiovascular comorbidity. Among the 110 patients (2.5% of 4325) with undiagnosed, clinically significant COPD, 53 had a positive screening result with a sensitivity of 48.2% (95% CI, 38.6%-57.9%) and a specificity of 88.6% (95% CI, 87.6%-89.6%). The area under the receiver operating curve for varying positive screening thresholds was 0.81 (95% CI, 0.77-0.85). Conclusions and Relevance: Within this US primary care population, the CAPTURE screening tool had a low sensitivity but a high specificity for identifying clinically significant COPD defined by presence of airflow obstruction that is of moderate severity or accompanied by a history of acute respiratory illness. Further research is needed to optimize performance of the screening tool and to understand whether its use affects clinical outcomes.

Development of the Advancing the Patient Experience in COPD Registry: A Modified Delphi Study.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is commonly managed by family physicians, but little is known about specifics of management and how this may be improved. The Advancing the Patient Experience in COPD (APEX COPD) registry will be the first U.S. primary care, health system-based registry following patients diagnosed with COPD longitudinally, using a standardized set of variables to investigate how patients are managed in real life and assess outcomes of various management strategies. OBJECTIVE: Gaining expert consensus on a standardized list of variables to capture in the APEX COPD registry. METHODS: A modified, Delphi process was used to reach consensus on which data to collect in the registry from electronic health records (EHRs), patient-reported information (PRI) and patient-reported outcomes (PRO), and by physicians during subsequent office visits. The Delphi panel comprised 14 primary care and specialty COPD experts from the United States and internationally. The process consisted of 3 iterative rounds. Responses were collected electronically. RESULTS: Of the initial 195 variables considered, consensus was reached to include up to 115 EHR variables, 34 PRI/PRO variables and 5 office-visit variables in the APEX COPD registry. These should include information on symptom burden, diagnosis, COPD exacerbations, lung function, quality of life, comorbidities, smoking status/history, treatment specifics (including side effects), inhaler management, and patient education/self-management. CONCLUSION: COPD experts agreed upon the core variables to collect from EHR data and from patients to populate the APEX COPD registry. Data will eventually be integrated, standardized and stored in the APEX COPD database and used for approved COPD-related research.

Protocol Summary of the COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) Validation in Primary Care Study.

Chronic obstructive pulmonary disease (COPD) often remains undiagnosed and untreated. To date, COPD screening/case finding has not been designed to identify clinically significant COPD, disease ready for therapies beyond smoking cessation. Herein, we describe the ongoing prospective, pragmatic cluster-randomized controlled trial to assess specificity and sensitivity of the COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) tool consisting of 5 questions and peak expiratory flow. The tool is designed to identify clinically significant COPD (forced expiratory volume in 1 second [FEV1] to forced vital capacity [FVC] ratio <.70 plus FEV1% predicted <60% or increased risk for exacerbation) and the trial will explore the impact of CAPTURE-based screening on COPD diagnosis and treatment rates in primary care patients. Of a total planned enrollment of 5000 English- or Spanish-speaking patients 45 to 80 years of age without a prior COPD diagnosis from 100 primary care practices, a total of 68 practices and 3064 patients have been enrolled in the study. Practices are centrally randomized to either usual care or clinician receipt of patient-level CAPTURE results. All clinicians receive basic COPD education with those in intervention practices also receiving CAPTURE interpretation education. In a single visit, patient participants complete a CAPTURE screening, pre- and post-bronchodilator spirometry and baseline demographic and health questionnaires to validate CAPTURE sensitivity, specificity, and predictive value of identifying undiagnosed, clinically significant COPD. One-year follow-up chart reviews and participant surveys assess the impact of sharing versus not sharing CAPTURE results with clinicians on clinical outcomes including level of respiratory symptoms and events and clinicians' initiation of recommendation-concordant COPD care. This is one of the first U.S. studies to validate and assess impact of a simple COPD screening tool in primary care.

Analysis of Vascular Event Risk After Herpes Zoster From 2007 to 2014 US Insurance Claims Data.

OBJECTIVE: To estimate the risk of transient ischemic attack (TIA), stroke, and myocardial infarction in periods covering 4 weeks before to 52 weeks after herpes zoster (HZ) diagnosis in US adults. PATIENTS AND METHODS: This retrospective study (GSK study identifier: HO-15-15771) with matched cohorts used the Truven Health MarketScan Commercial and Medicare claims data set linked with obesity and smoking status information. Patients 18 years and older at the date of HZ diagnosis and 1-year pre- and post-HZ diagnosis continuous insurance enrollment (from January 1, 2007, through December 31, 2014) were propensity score matched to controls in terms of demographic characteristics, risk factors for vascular events, other comorbid disorders, general health, obesity, and smoking status. A post hoc sensitivity analysis was performed not matching for obesity and smoking status information. Adjusted incidence rate ratios (IRRs) were estimated using multivariate Poisson models during an aggregate period (1-month before and after the index date). RESULTS: A total of 23,339 patients with HZ were matched to 46,378 controls (mean age, 56 years; 45,173 [65%] women). During the aggregate period, patients with HZ were statistically significantly more likely to suffer a TIA: IRRs for all patients and patients aged 18 to 49 years were 1.56 (95% confidence interval [CI], 1.13-2.15) and 5.12 (95% CI, 1.37-19.10), respectively (P<.05); the respective IRRs for stroke were 1.40 (95% CI, 0.93-2.11) and 8.12 (95% CI, 0.93-71.27). In the sensitivity analysis, IRRs for TIA and stroke were statistically significantly increased regardless of age. CONCLUSION: Herpes zoster was associated with an increased risk of composite events, TIA, and stroke in adults in the period around diagnosis. More research on the HZ and vascular risk association is needed. GSK STUDY IDENTIFIER: HO-15-15771.

Practical Considerations for the Diagnosis and Management of Asthma in Older Adults.

Although often considered a disease of childhood, the prevalence of asthma in US adults aged 65 years or older is similar to that in children, with the number of older patients needing care for asthma likely to continue to increase. As with most chronic diseases, there are challenges associated with the diagnosis and management of asthma in an older population. This review discusses these challenges, suggesting practical management strategies for primary care physicians and their teams. Asthma comprises a spectrum of phenotypes, some associated with adult onset. The symptoms and characteristics of patients with late-onset asthma can differ from those of patients with early-onset disease. Furthermore, older patients may fail to recognize respiratory symptoms as abnormal and have other comorbidities, complicating the differential diagnosis of asthma. Once diagnosed, the long-term goals of asthma management are no different in older adults than in anyone with asthma, with inhaled corticosteroids being the cornerstone of therapy. Comorbid conditions become more common with age and have a direct impact on a patient's respiratory symptoms and potential adverse effects of therapy, thereby influencing the choice of therapies and delivery systems and potentially increasing the likelihood of complex polypharmacy. In conclusion, asthma, although traditionally considered a disease of the young, should be considered as a potential diagnosis in older adults with respiratory symptoms, even without a history of asthma or allergies. As with all patients, the primary goals of asthma management in older adults are symptom control and exacerbation reduction.

Parkinson Disease and Melanoma: Confirming and Reexamining an Association.

OBJECTIVE: To examine an association between melanoma and Parkinson disease (PD). PATIENTS AND METHODS: Phase I: Rochester Epidemiology Project records were used to identify (between January 1, 1976, and December 31, 2013) patients with PD in Olmsted County, Minnesota, with 3 matched controls per case. After review, JMP statistical software with logistic regression analysis was used to assess the risk of preexisting melanoma in patients with PD vs controls. Phase II: All Rochester Epidemiology Project cases of melanoma were identified (between January 1, 1976, and December 31, 2014), with 1 control per case. A Cox proportional hazards model was used to assess the risk of developing PD after the index date in cases vs controls, and Kaplan-Meier analysis was performed to determine the 35-year cumulative risk of PD. A Cox proportional hazards model was used to assess the risk of death from metastatic melanoma in patients with melanoma without PD compared with those with PD. RESULTS: Phase I: Patients with PD had a 3.8-fold increased likelihood of having preexisting melanoma as compared with controls (95% CI, 2.1-6.8; P<.001). Phase II: Patients with melanoma had a 4.2-fold increased risk of developing PD (95% CI, 2.0-8.8; P<.001). Kaplan-Meier analysis revealed an increased 35-year cumulative risk of PD in patients with melanoma (11.8%) compared with controls (2.6%) (P<.001). Patients with melanoma without PD had a 10.5-fold increased relative risk of death from metastatic melanoma compared with patients with melanoma with PD (95% CI, 1.5-72.2) (P=.02). CONCLUSION: There appears to be an association between melanoma and PD. Further study is warranted; but on the basis of these results, physicians may consider counseling patients with melanoma about PD risk and implementing cutaneous and ocular melanoma surveillance in patients with PD.

Developing a standardized healthcare cost data warehouse.

BACKGROUND: Research addressing value in healthcare requires a measure of cost. While there are many sources and types of cost data, each has strengths and weaknesses. Many researchers appear to create study-specific cost datasets, but the explanations of their costing methodologies are not always clear, causing their results to be difficult to interpret. Our solution, described in this paper, was to use widely accepted costing methodologies to create a service-level, standardized healthcare cost data warehouse from an institutional perspective that includes all professional and hospital-billed services for our patients. METHODS: The warehouse is based on a National Institutes of Research-funded research infrastructure containing the linked health records and medical care administrative data of two healthcare providers and their affiliated hospitals. Since all patients are identified in the data warehouse, their costs can be linked to other systems and databases, such as electronic health records, tumor registries, and disease or treatment registries. RESULTS: We describe the two institutions' administrative source data; the reference files, which include Medicare fee schedules and cost reports; the process of creating standardized costs; and the warehouse structure. The costing algorithm can create inflation-adjusted standardized costs at the service line level for defined study cohorts on request. CONCLUSION: The resulting standardized costs contained in the data warehouse can be used to create detailed, bottom-up analyses of professional and facility costs of procedures, medical conditions, and patient care cycles without revealing business-sensitive information. After its creation, a standardized cost data warehouse is relatively easy to maintain and can be expanded to include data from other providers. Individual investigators who may not have sufficient knowledge about administrative data do not have to try to create their own standardized costs on a project-by-project basis because our data warehouse generates standardized costs for defined cohorts upon request.

Patient Factors Influencing Respiratory-Related Clinician Actions in Chronic Obstructive Pulmonary Disease Screening.

INTRODUCTION: The purpose of this study was to identify patient-related factors that may explain the increased likelihood of receiving a respiratory-related clinician action in patients identified to be at risk for chronic obstructive pulmonary disease in a U.S.-based pragmatic study of chronic obstructive pulmonary disease screening. METHODS: This post hoc analysis (conducted in 2014-2015) of the Screening, Evaluating and Assessing Rate Changes of Diagnosing Respiratory Conditions in Primary Care 1 (SEARCH1) study (conducted in 2010-2011), used the chronic obstructive pulmonary disease Population Screener questionnaire in 112 primary care practices. Anyone with a previous chronic obstructive pulmonary disease diagnosis was excluded. Multivariate logistic regression modeling was used to assess patient factors associated with the likelihood of receiving an respiratory-related clinician action following positive screening. RESULTS: Overall, 994 of 6,497 (15%) screened positive and were considered at risk for chronic obstructive pulmonary disease. However, only 187 of the 994 patients (19%) who screened positive received a respiratory-related clinician action. The chances of receiving a respiratory-related clinician action were significantly increased in patients who visited their physician with a respiratory issue (p<0.05) or had already been prescribed a respiratory medication (p<0.05). Most (81%) patients who screened positive or had a respiratory-related clinician action had one or more comorbidity, including cardiovascular disease (68%), diabetes (30%), depression/anxiety (26%), asthma (11%), and cancer (9%). CONCLUSIONS: Routine chronic obstructive pulmonary disease screening appears to promote respiratory-related clinician actions in patients with a high likelihood for disease who have respiratory complaints or already use prescribed respiratory medication.

Incidence of Type 1 Diabetes Is Not Increasing in a Population-Based Cohort in Olmsted County, Minnesota, USA.

OBJECTIVES: To investigate the recent incidence of T1D in a US Midwestern county to determine whether this increase has been sustained and compare it with the incidence of celiac disease (CD) and also investigate the prevalence of CD, an associated autoimmune disease, within the cohort. PATIENTS AND METHODS: A broad search strategy was used to identify all incident cases of T1D in Olmsted County, Minnesota, between January 1, 1994, and December 31, 2010, using the Rochester Epidemiology Project. Diagnosis and residency status were confirmed through the medical record. Incidence rates were directly standardized to the 2010 US population. Poisson regression was used to test for a change in incidence rate. Clinical charts were reviewed to confirm case status. RESULTS: There were 233 incident cases of T1D. Directly adjusting for age and sex with respect to the 2010 US white population, the overall annual incidence of T1D was 9.2 (95% CI, 8.0-10.4) per 100,000 people per year among all ages and 19.9 (95% CI, 16.6-23.2) per 100,000 people per year for those younger than 20 years. There was no significant increase in the incidence of T1D over time (P=.45). Despite the overall stability in annual incidence, there was an initial increasing trend followed by a plateau. Of the 109 patients with T1D (47%) tested for CD, 12% (13) had biopsy-proven CD. CONCLUSION: The incidence of T1D has stopped increasing in Olmsted County, Minnesota, in the most recent decade. Further studies are needed to confirm this finding and explore reasons for this plateau.

Assessing health disparities in children using a modified housing-related socioeconomic status measure: a cross-sectional study.

OBJECTIVES: Socioeconomic status (SES) is a well-established risk factor for many health outcomes. Recently, we developed an SES measure based on 4 housing-related characteristics (termed HOUSES) and demonstrated its ability to assess health disparities. In this study, we aimed to evaluate whether fewer housing-related characteristics could be used to provide a similar representation of SES. STUDY SETTING AND PARTICIPANTS: We performed a cross-sectional study using parents/guardians of children aged 1-17 years from 2 US Midwestern counties (n=728 in Olmsted County, Minnesota, and n=701 in Jackson County, Missouri). PRIMARY AND SECONDARY OUTCOME MEASURES: For each participant, housing-related characteristics used in the formulation of HOUSES (assessed housing value, square footage, number of bedrooms and number of bathrooms) were obtained from the local government assessor's offices, and additional SES measures and health outcomes with known associations to SES (obesity, low birth weight and smoking exposure) were collected from a telephone survey. Housing characteristics with the greatest contribution for predicting the health outcomes were added to formulate a modified HOUSES index. RESULTS: Among the 4 housing characteristics used in the original HOUSES, the strongest contributions for predicting health outcomes were observed from assessed housing value and square footage (combined contribution ranged between 89% and 96%). Based on this observation, these 2 were used to calculate a modified HOUSES index. Correlation between modified HOUSES and other SES measures was comparable to the original HOUSES for both locations. Consistent with the original HOUSES formula, the strongest association with modified HOUSES was observed with smoking exposure (OR=0.24 with 95% CI 0.11 to 0.49 for comparing participants in highest HOUSES vs lowest group; overall p<0.001). CONCLUSIONS: The modified HOUSES requires only 2 readily available housing characteristics thereby improving the feasibility of using this index as a proxy for SES in multiple communities, especially in the US Midwestern region.

Risk Factors for Herpes Zoster Among Adults.

Background. The causes of varicella-zoster virus reactivation and herpes zoster (HZ) are largely unknown. We assessed potential risk factors for HZ, the data for which cannot be obtained from the medical sector. Methods. We conducted a matched case-control study. We established active surveillance in Olmsted County, Minnesota to identify HZ occurring among persons age ≥50 years during 2010-2011. Cases were confirmed by medical record review. Herpes zoster-free controls were age- and sex-matched to cases. Risk factor data were obtained by telephone interview. Results. We enrolled 389 HZ case patients and 511 matched controls; the median age was 65 and 66 years, respectively. Herpes zoster was associated with family history of HZ (adjusted odds ratio [aOR] = 1.65); association was highest with first-degree or multiple relatives (aOR = 1.87 and 3.08, respectively). Herpes zoster was also associated with prior HZ episodes (aOR = 1.82), sleep disturbance (aOR = 2.52), depression (aOR = 3.81), and recent weight loss (aOR = 1.95). Stress was a risk factor for HZ (aOR = 2.80), whereas a dose-response relationship was not noted. All associations indicated were statistically significant (P < .05). Herpes zoster was not associated with trauma, smoking, tonsillectomy, diet, or reported exposure to pesticides or herbicides (P > .1). Conclusions. We identified several important risk factors for HZ; however, the key attributable causes of HZ remain unknown.

A retrospective study of two populations to test a simple rule for spirometry.

BACKGROUND: Chronic lung disease is common and often under-diagnosed. METHODS: To test a simple rule for conducting spirometry we reviewed spirograms from two populations, occupational medicine evaluations (OME) conducted by Saint Louis and Wake Forest Universities at 3 sites (n = 3260, mean age 64.14 years, 95 % CI 58.94-69.34, 97 % men) and conducted by Wake Forest University preop clinic (POC) at one site (n = 845, mean age 62.10 years, 95 % CI 50.46-73.74, 57 % men). This retrospective review of database information that the first author collected prospectively identified rates, types, sensitivity, specificity and positive and negative predictive value for lung function abnormalities and associated mortality rate found when conducting spirometry based on the 20/40 rule (≥20 years of smoking in those aged ≥ 40 years) in the OME population. To determine the reproducibility of the 20/40 rule for conducting spirometry, the rule was applied to the POC population. RESULTS: A lung function abnormality was found in 74 % of the OME population and 67 % of the POC population. Sensitivity of the rule was 85 % for an obstructive pattern and 77 % for any abnormality on spirometry. Positive and negative predictive values of the rule for a spirometric abnormality were 74 and 55 %, respectively. Patients with an obstructive pattern were at greater risk of coronary heart disease (odds ratio (OR) 1.39 [confidence interval (CI) 1.00-1.93] vs. normal) and death (hazard ratio (HR) 1.53, 95 % CI 1.20-1.84) than subjects with normal spirometry. Restricted spirometry patterns were also associated with greater risk of coronary disease (odds ratio (OR) 1.7 [CI 1.23-2.35]) and death (Hazard ratio 1.40, 95 % CI 1.08-1.72). CONCLUSIONS: Smokers (≥ 20 pack years) age ≥ 40 years are at an increased risk for lung function abnormalities and those abnormalities are associated with greater presence of coronary heart disease and increased all-cause mortality. Use of the 20/40 rule could provide a simple method to enhance selection of candidates for spirometry evaluation in the primary care setting.