CHARTING PROGRESS IN THE SOFTWARE ACQUISITION PATHWAY

The Department of the Navy (DON) recently implemented the Department of Defense (DOD) Software Acquisition Pathway (SWP), a software acquisition strategy for custom application and embedded software. The purpose of the SWP is to enable rapid and iterative delivery of high-priority software capability to the intended user. But while the SWP uses an agile software development approach, neither the DOD nor the DON have yet provided comprehensive governance tools and methods for SWP programs to iteratively plan, track, and assess acquisition outcomes in agile environments. To close this gap, the author systematically researched commercial software engineering management and digital product development practices as well as prior DOD software acquisition reform studies. Based on the results, the author showed that Earned Value Management is incompatible with the SWP and recommended alternative techniques to measure cost and schedule performance. Additionally, the author recommended a phased approach to manage DON SWP custom application programs, whereby a minimal, unitless work breakdown structure is used to track progress until demonstrating the minimum viable product to the user in a testing environment; product-based metrics are then tracked until initial release of the custom application software; and then outcome-based goals are iteratively set, tracked, and assessed using the Objectives and Key Results framework for as long as the custom application software is in use.Captain, United States Air ForceApproved for public release. Distribution is unlimited

Effect of Zephyr Endobronchial Valves on Dyspnea, Activity Levels, and Quality of Life at One Year Results from a Randomized Clinical Trial

Rationale: Bronchoscopic lung volume reduction with Zephyr Valves improves lung function, exercise tolerance, and quality of life of patients with hyperinflated emphysema and little to no collateral ventilation. Objectives: Post hoc analysis of patient-reported outcomes (PROs), including multidimensional measures of dyspnea, activity, and quality of life, in the LIBERATE (Lung Function Improvement after Bronchoscopic Lung Volume Reduction with Pulmonx Endobronchial Valves used in Treatment of Emphysema) study are reported. Methods: A total of 190 patients with severe heterogeneous emphysema and little to no collateral ventilation in the target lobe were randomized 2:1 to the Zephyr Valve or standard of care. Changes in PROs at 12 months in the two groups were compared: dyspnea with the Transitional Dyspnea Index (TDI), focal score; the Chronic Obstructive Pulmonary Disease Assessment Test (CAT; breathlessness on hill/stairs); Borg; the EXAcerbations of Chronic pulmonary disease Tool-PRO, dyspnea domain; activity with the TDI, magnitude of task/effort/functional impairment, CAT (limited activities), and the St. George's Respiratory Questionnaire (SGRQ), activity domain; and psychosocial status with the SGRQ, impacts domain, and CAT (confidence and energy). Results: At 12 months, patients using the Zephyr Valve achieved statistically significant and clinically meaningful improvements in the SGRQ; CAT; and the TDI, focal score, compared with standard of care. Improvements in the SGRQ were driven by the impacts and activity domains (P, 0.05 and P, 0.001, respectively). Reduction in CAT was through improvements in breathlessness (P, 0.05), energy level (P, 0.05), activities (P, 0.001), and increased confidence when leaving home (P, 0.05). The TDI measures of effort, task, and functional impairment were uniformly improved (P, 0.001). The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT)-PRO, dyspnea domain, was significantly improved in the Zephyr Valve group. Improvements correlated with changes in residual volume and residual volume/TLC ratio. Conclusions: Patients with severe hyperinflated emphysema achieving lung volume reductions with Zephyr Valves experience improvements in multidimensional scores for breathlessness, activity, and psychosocial parameters out to at least 12 months

A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE)

Rationale: This is the first multicenter randomized controlled trial to evaluate the effectiveness and safety of Zephyr Endobronchial Valve (EBV) in patients with little to no collateral ventilation out to 12 months. Objectives: To evaluate the effectiveness and safety of Zephyr EBV in heterogeneous emphysema with little to no collateral ventilation in the treated lobe. Methods: Subjects were enrolled with a 2:1 randomization (EBV/standard of care [SoC]) at 24 sites. Primary outcome at 12 months was the Delta EBV-SoC of subjects with a post-bronchodilator FEV1 improvement from baseline of greater than or equal to 15%. Secondary endpoints included absolute changes in post-bronchodilator FEV1, 6-minute-walk distance, and St. George's Respiratory Questionnaire scores. Measurements and Main Results: A total of 190 subjects (128 EBV and 62 SoC) were randomized. At 12 months, 47.7% EBV and 16.8% SoC subjects had a Delta FEV1 greater than or equal to 15% (P <0.001). DEBV-SoC at 12 months was statistically and clinically significant: for FEV1, 0.106 L (P <0.001); 6-minute-walk distance, +39.31 m (P = 0.002); and St. George's Respiratory Questionnaire, -7.05 points (P = 0.004). Significant DEBV-SoC were also observed in hyperinflation (residual volume, -522 ml; P <0.001), modified Medical Research Council Dyspnea Scale (-0.8 points; P <0.001), and the BODE (body mass index, airflow obstruction, dyspnea, and exercise capacity) index (-1.2 points). Pneumothorax was the most common serious adverse event in the treatment period (procedure to 45 d), in 34/128 (26.6%) of EBV subjects. Four deaths occurred in the EBV group during this phase, and one each in the EBV and SoC groups between 46 days and 12 months. Conclusions: Zephyr EBV provides clinically meaningful benefits in lung function, exercise tolerance, dyspnea, and quality of life out to at least 12 months, with an acceptable safety profile in patients with little or no collateral ventilation in the target lobe