How Well Does CAPTURE Translate?: An Exploratory Analysis of a COPD Case-Finding Method for Spanish-Speaking Patients.

BACKGROUND: This study tested the properties of a Spanish translation of CAPTURE (COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk) with selective use of peak expiratory flow (PEF). METHODS: This study comprised analyses of data from the Spanish-speaking cohort of the cross-sectional, case-control study used to develop CAPTURE. Translation procedures included forward and backward translation, reconciliation, and cognitive interviewing to assure linguistic and cultural equivalence, yielding CAPTURE-S. Spanish-speaking participants were recruited through one center and designated as case subjects (clinically significant COPD: FEV1 ≤ 60% predicted and/or at risk of COPD exacerbation) or control subjects (no or mild COPD). Subjects completed a questionnaire booklet that included 44 candidate items, the COPD Assessment Test (CAT), and the modified Medical Research Council (mMRC) dyspnea question. PEF and spirometry were also performed. RESULTS: The study included 30 participants (17 case subjects and 13 control subjects). Their mean (± SD) age was 62.6 (11.49) years, and 33% were male. CAPTURE-S scores were significantly correlated with PEF (r = -0.78), the FEV1/FVC ratio (r = -0.74), FEV1 (r = -0.69), FEV1 % predicted (r = -0.69), the CAT score (r = 0.70), and the mMRC dyspnea question (r = 0.59) (P < .0001), with significantly higher scores in case subjects than in control subjects (t = 6.16; P < .0001). PEF significantly correlated with FEV1 (r = 0.89), FEV1 % predicted (r = 0.79), and the FEV1/FVC ratio (r = 0.75) (P < .0001), with significantly lower PEF in case subjects than in control subjects (t = 5.08; P < .0001). CAPTURE-S score + PEF differentiated case subjects and control subjects with a sensitivity of 88.2% and a specificity of 92.3%. CONCLUSIONS: CAPTURE-S with selective use of PEF seems to be useful for identifying Spanish-speaking patients in need of diagnostic evaluation for clinically significant COPD who may benefit from initiation of COPD treatment. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01880177; URL: www.clinicaltrials.gov.

The safety, efficacy, and durability of lung-volume reduction surgery: A 10-year experience.

OBJECTIVES: The National Emphysema Treatment Trial (NETT) validated the efficacy of lung-volume reduction surgery (LVRS) in selected patients with emphysema; however, concerns about the safety and durability of the operation have limited its clinical application. We evaluated our experience with LVRS, for the time period since approval was given by the Centers for Medicare and Medicaid Services, with respect to surgical morbidity and mortality, early and late functional outcomes, and long-term survival. METHODS: Retrospective analysis was performed on 91 patients for whom consent was obtained for bilateral LVRS at our institution between January 2004 and June 2014. Primary outcomes analyzed were 6-month surgical mortality and overall survival at 1, 2, and 5 years. Secondary outcomes (forced expiratory volume in 1 second [FEV1], residual volume, carbon monoxide diffusing capacity, a 6-minute walk test, exercise capacity, and a shortness-of-breath questionnaire) were analyzed for mean change from baseline at 1, 2, and 5 years after LVRS. RESULTS: The 6-month surgical mortality rate was 0%. At the 1- and 5-year follow-up, 69% and 36% of the patients had an improvement in FEV1. The 1-, 2-, and 5-year FEV1 change in % predicted of the FEV1, compared with baseline after LVRS, respectively, was 11.1% (95% CI: 8.6%, 13.6%); 8.7% (95% CI: 6.1%, 11.4%); and 11.1% (95% CI: 7.1%, 15.0%); and the maximal workload (in watts [W]) had an average increase of: 10.7 W (95% CI: 6.9, 14.6); 7.6 W (95% CI: 2.8, 12.4); and 10.24 W (95% CI: 4.4, 16.1). Overall survival (95% CI) for the group was: 0.99 (95% CI: 0.96, 1.00) at 1 year; 0.97 (95% CI: 0.93, 1.00) at 2 years; and 0.78 (95% CI: 0.67, 0.89) at 5 years. CONCLUSIONS: Given proper patient selection, LVRS is a safe operation. Early functional measurements are consistent with significant clinical benefit. Long-term results demonstrate that improvements can be durable. Surgical LVRS continues to represent the standard for lung-volume reduction therapy.

Quantification of Improvements in Static and Dynamic Ventilatory Measures Following Lung Volume Reduction Surgery for Severe COPD.

Rationale: This study quantitatively measured the effects of lung volume reduction surgery (LVRS) on spirometry, static and dynamic lung and chest wall volume subdivision mechanics, and cardiopulmonary exercise measures. Methods: Patients with severe COPD (mean FEV1 = 23 ± 6% predicted) undergoing LVRS evaluation were recruited. Spirometry, plethysmography and exercise capacity were obtained within 6 months pre-LVRS and again within 12 months post- LVRS. Ventilatory mechanics were quantified using stationary optoelectronic plethysmography (OEP) during spontaneous tidal breathing and during maximum voluntary ventilation (MVV). Statistical significance was set at P< 0.05. Results:Ten consecutive patients met criteria for LVRS (5 females, 5 males, age: 62±6yrs). Post -LVRS (mean follow up 7 months ± 2 months), the group showed significant improvements in dyspnea scores (pre 4±1 versus post 2 ± 2), peak exercise workload (pre 37± 21 watts versus post 50 ± 27watts ), heart rate (pre 109±19 beats per minutes [bpm] versus post 118±19 bpm), duty cycle (pre 30.8 ± 3.8% versus post 38.0 ± 5.7%), and spirometric measurements (forced expiratory volume in 1 second [FEV1] pre 23 ± 6% versus post 32 ± 13%, total lung capacity / residual lung volume pre 50 ± 8 versus 50 ± 11) . Six to 12 month changes in OEP measurements were observed in an increased percent contribution of the abdomen compartment during tidal breathing (41.2±6.2% versus 44.3±8.9%, P=0.03) and in percent contribution of the pulmonary ribcage compartment during MVV (34.5±10.3 versus 44.9±11.1%, P=0.02). Significant improvements in dynamic hyperinflation during MVV occurred, demonstrated by decreases rather than increases in end expiratory volume (EEV) in the pulmonary ribcage (pre 207.0 ± 288.2 ml versus post -85.0 ± 255.9 ml) and abdominal ribcage compartments (pre 229.1 ± 182.4 ml versus post -17.0 ± 136.2 ml) during the maneuver. Conclusions: Post-LVRS, patients with severe COPD demonstrate significant favorable changes in ventilatory mechanics, during tidal and maximal voluntary breathing. Future work is necessary to determine if these findings are clinically relevant, and extend to other environments such as exercise.

Feasibility and Acceptability of Utilizing a Smartphone Based Application to Monitor Outpatient Discharge Instruction Compliance in Cardiac Disease Patients around Discharge from Hospitalization.

The purpose of this study was to determine the feasibility and acceptability of utilizing a smartphone based application to monitor compliance in patients with cardiac disease around discharge. For 60 days after discharge, patients' medication compliance, physical activity, follow-up care, symptoms, and reading of education material were monitored daily with the application. 16 patients were enrolled in the study (12 males, 4 females, age 55 ± 18 years) during their hospital stay. Five participants were rehospitalized during the study and did not use the application once discharged. Seven participants completed 1-30 days and four patients completed >31 days. For those 11 patients, medication reminders were utilized 37% (1-30-day group) and 53% (>31-day group) of the time, education material was read 44% (1-30) and 53% (>31) of the time, and physical activity was reported 25% (1-30) and 42% (>31) of the time. Findings demonstrated that patients with stable health utilized the application, even if only minimally. Patients with decreased breath sounds by physical exam and who reported their health as fair to poor on the day of discharge were less likely to utilize the application. Acceptability of the application to report health status varied among the stable patients.

Sildenafil for chronic obstructive pulmonary disease: a randomized crossover trial.

RATIONALE: Pulmonary hypertension with exercise is common in chronic obstructive pulmonary disease (COPD) and may contribute to exercise limitation in this disease. We aimed to determine the effects of treatment with sildenafil on exercise capacity in patients with COPD and emphysema. METHODS: We performed a randomized, double-blind, placebo-controlled 2-period crossover trial of sildenafil thrice daily in ten adults with COPD and emphysema on CT scan without pulmonary hypertension. We randomized study participants to 4 weeks of sildenafil (or placebo) followed by a 1-week washout and then 4 weeks of placebo (or sildenafil). The 2 primary outcomes were the 6-minute walk distance and oxygen consumption at peak exercise. RESULTS: Sildenafil had no effect on 6-minute walk distance (placebo-corrected difference = -7.8 m, 95% confidence interval, -23.2 to 7.5 m, p = 0.35) or oxygen consumption at peak exercise (placebo-corrected difference = -0.1 ml/kg/min, 95% confidence interval -2.1 to 1.8 ml/kg/min, p = 0.89). Sildenafil increased the alveolar-arterial oxygen gradient (p = 0.02), worsened symptoms (p = 0.04), and decreased quality-of-life (p = 0.03). Adverse events were more frequent while receiving sildenafil (p = 0.005). CONCLUSIONS: Routine sildenafil administration did not have a beneficial effect on exercise capacity in patients with COPD and emphysema without pulmonary hypertension. Sildenafil significantly worsened gas exchange at rest and quality of life. (clinicaltrials.gov NCT00104637).

Exercise ventilatory kinematics in endurance trained and untrained men and women.

To determine how increased ventilatory demand impacts ventilatory kinematics, we compared the total chest wall volume variations (V(CW)) of male and female endurance-trained athletes (ET) to untrained individuals (UT) during exercise. We hypothesized that training and gender would have an effect on V(CW) and kinematics at maximal exercise. Gender and training significantly influenced chest wall kinematics. Female ET did not change chest wall end-expiratory volume (V(CW,ee)) or pulmonary ribcage (V(RCp,ee)) with exercise, while female UT significantly decreased V(CW,ee) and V(RCp,ee) with exercise (p<0.05). Female ET significantly increased pulmonary ribcage end-inspiratory volume (V(RCp,ei)) with exercise (p<0.05), while female UT did not change V(RCp,ei) with exercise. Male ET significantly increased V(RCp,ei) with exercise (p<0.05); male UT did not. Men and women had significantly different variation of V(CW) (p<0.05). Women demonstrated the greatest variation of V(CW) in the pulmonary ribcage compartment (V(RCp)). Men had even volumes variation of the V(RCp) and the abdomen (V(Ab)). In conclusion, gender and training had a significant impact on ventilatory kinematics.

Lung volume reduction surgery using the NETT selection criteria.

BACKGROUND: The National Emphysema Treatment Trial (NETT) proved that lung volume reduction surgery (LVRS) was safe and effective in patients with certain clinical characteristics and using defined inclusion-exclusion criteria. Based on the selection criteria developed in that trial, we performed bilateral LVRS on 49 patients during the period of February 2004 until May 2009. METHODS: Forty-nine patients underwent lung volume reduction by either median sternotomy (10) or video-assisted thoracoscopic surgery (39) selected according to NETT described parameters. Preoperative characteristics were the following: mean (±SD) age 62.5±6.6 years, preoperative FEV1 (forced expiratory volume in the first second of expiration) 691 cc (±159), % of predicted FEV1 25.3 (±6.2), preoperative Dlco (diffusing capacity of lung for carbon monoxide) 7.6 (±2.7), and % of predicted DLCO 27% (±7.3). All patients had upper lobe predominant disease and either low exercise capacity (n=23) or high exercise capacity (n=26) as defined by the NETT. RESULTS: There was no operative or 90-day mortality. Median length of stay was 8 days (interquartile range=6 to 10). Two patients required reintubation and tracheostomy but were decannulated prior to discharge. The BODE index (body mass index, airflow obstruction, dyspnea, and exercise capacity), a multidimensional predictor of survival in chronic obstructive pulmonary disease, improved -2.3 (±1.5, p<0.0001) (missing data: 5 of 42, 11.9%) and the FEV1 improved 286 cc (±221, p<0.0001), both 1 year after surgery. Probability of survival was 0.98 (95% CI [confidence interval]=0.94 to 1) at 1 year, and 0.95 (95% CI=0.88 to 1) at 3 years. CONCLUSIONS: Surgical lung volume reduction for emphysema can be performed in patients using selection criteria developed by the NETT with very low surgical risk and excellent midterm results. Surgical LVRS is the standard against which other nonsurgical treatments for advanced emphysema should be judged.

NETT coordinators: researchers, caregivers, or both?

The National Emphysema Treatment Trial (NETT) required the coordinated evaluation and treatment of thousands of patients with emphysema simultaneous with data collection to evaluate the safety and efficacy of surgery versus medical treatment for emphysema. These tasks were performed by a multidisciplinary team led by the clinic coordinator at each NETT center. The clinic coordinators functioned as members of the research team as well as communicators, managers, and members of the patient care team. The clinic coordinators' ability to balance these roles was instrumental to the successful completion of NETT, as evidenced by randomization of 1,218 subjects with only 10 subjects being lost to follow-up. Striving to achieve recruitment goals and working to retain study subjects was very labor intensive. The coordinator role was complicated by the study population's severity of illness combined with the complexity of the NETT protocol. Management of the study subjects' medical condition had to be balanced with the management of a multicenter, randomized clinical trial to ensure quality data collection and protocol adherence.

Multidisciplinary care of the patient with chronic obstructive pulmonary disease.

The National Emphysema Treatment Trial used a multidisciplinary team approach to implement the maximum medical care protocol, including adjustment of medications and outpatient pulmonary rehabilitation for all patients and nutritional and psychological counseling as needed. This article discusses the benefits of such an approach in the care of the patient with chronic obstructive pulmonary disease. Team member roles complement each other and contribute to the goal of providing the highest-quality medical care. The primary focus of the team is to reinforce the medical plan and to provide patient education and support. This article reviews the elements of the initial patient assessment and the functional and nutritional assessment. Patient education focuses on medication use, recognition and management of chronic obstructive pulmonary disease exacerbation symptoms, smoking cessation, advance directives, and travel.

Lung-volume reduction surgery for pulmonary emphysema: Improvement in body mass index, airflow obstruction, dyspnea, and exercise capacity index after 1 year.

OBJECTIVES: We hypothesized that lung-volume reduction surgery for pulmonary emphysema would improve body mass index, airflow obstruction, dyspnea, and exercise capacity (BODE) index, a multidimensional predictor of survival in chronic obstructive pulmonary disease. We also aimed to identify preoperative predictors of improvement in the BODE index. METHODS: In a prospective cohort study of patients undergoing lung-volume reduction surgery at our center, with the methodology of the National Emphysema Treatment Trial, we compared clinical characteristics before and 1 year after surgery with the Wilcoxon signed rank test. Changes in the BODE index were correlated with preoperative variables with the Spearman correlation coefficient. RESULTS: Twenty-three patients with predominantly upper-lobe pulmonary emphysema underwent lung-volume reduction surgery (14 by video-assisted thoracoscopic surgery, 9 by median sternotomy). There were no postoperative or follow-up deaths. The BODE index improved from a median of 5 (interquartile range 4-5) before surgery to 3 (interquartile range 2-4) 1 year after surgery (P < .0001). Improvements were seen in the lung function and dyspnea components of the BODE index. Lower preoperative 6-minute walk distance and lower postwalk Borg fatigue scores were each associated with greater improvement in the BODE index after 1 year. CONCLUSION: Lung-volume reduction surgery for pulmonary emphysema improved the BODE index in patients with predominantly upper-lobe disease. Lower preoperative 6-minute walk distance correlated with greater improvement in the BODE index.