Randomized Trials of Nasal Patency and Dermal Tolerability With External Nasal Dilators in Healthy Volunteers

Background External nasal dilator strips are used as nonpharmacological therapy to reduce snoring and daytime sleepiness. In a product improvement initiative, a marketed strip (BRNS) and 2 prototype nasal strips were evaluated. Objective To compare the nasal patency and multiple-use dermal tolerability of the BRNS and prototype nasal strips using both objective and subject-reported outcome measures. Methods Two studies were conducted separately in healthy volunteers ≥18 years of age. A single-day nasal patency randomized crossover study assessed minimal cross-sectional area (MCA; second restriction) and nasal volume (using acoustic rhinometry); nasal inspiratory flow and resistance (using posterior rhinomanometry); and subject-reported evaluations of the BRNS compared with the butterfly strip and teardrop strip prototypes. A single-center, randomized, controlled, parallel-group, evaluator-blinded study assessed dermal tolerability of the BRNS and the butterfly strip over 7 consecutive nights of use, using the Dermal Response Scale (DRS) and subject-reported comfort and ease of removal. Results In the Patency study (N = 50), all 3 strips demonstrated significant improvement from baseline in MCA, nasal volume, and nasal flow parameters (resistance and peak flow). The prototype strips demonstrated significantly more improvement in nasal volume than the BRNS, and the butterfly strip showed significantly more improvement in MCA than the BRNS; all strips were similar with respect to nasal flow and subject-reported nasal breathing outcomes. In the Dermal Tolerability study (N = 82), all subjects scored 0 (no evidence of irritation) on the DRS at all 7 morning assessments; the BRNS was numerically, but not significantly, superior to the butterfly strip on subject-reported outcomes. Conclusion The Patency study demonstrated significant improvement from baseline in nasal dimensions and flow for all 3 evaluated strips; between-strip differences were confined to nasal dimensions. Both the BRNS and butterfly strip were generally well tolerated, with no evidence of dermal response over 7 consecutive nights of use. ClinicalTrials.gov identifiers: NCT01105949 and NCT0149549

The American College of Surgeons Needs-Based Assessment of Trauma Systems

BackgroundIn 2015, the American College of Surgeons Committee on Trauma convened a consensus conference to develop the Needs-Based Assessment of Trauma Systems (NBATS) tool to assist in determining the number of trauma centers required for a region. We tested the performance of NBATS with respect to the optimal number of trauma centers needed by region in California.MethodsTrauma center data were obtained from the California Emergency Services Authority Information Systems (CEMSIS). Numbers of admitted trauma patients (ISS > 15) were obtained using statewide nonpublic admissions data from the California Office of Statewide Health Planning and Development (OSHPD), CEMSIS, and data from local emergency medical service agency (LEMSA) directors who agreed to participate in a telephone survey. Population estimates per county for 2014 were obtained from the U.S. Census. NBATS criteria used included population, transport time, community support, and number of discharges for severely injured patients (ISS > 15) at nontrauma centers and trauma centers. Estimates for the number of trauma centers per region were created for each of the three data sources and compared to the number of existing centers.ResultsA total of 62 state-designated trauma centers were identified for California: 13 (21%) Level I, 36 (58%) Level II, and 13 (11%) Level III. NBATS estimates for the total number of trauma centers in California were 27% to 47% lower compared to the number of trauma centers in existence, but this varied based on urban/rural status. NBATS estimates were lower than the current state in 70% of urban areas but were higher in almost 90% of rural areas. All data sources (OSHPD, CEMSIS, local data) produced similar results.ConclusionEstimates from the NBATS tool are different from what is currently in existence in California, and differences exist based on whether the region is rural or urban. Findings from the current study can help inform future iterations of the NBATS tool.Level of evidenceEconomic, level V

The American College of Surgeons Needs-Based Assessment of Trauma Systems

BackgroundIn 2015, the American College of Surgeons Committee on Trauma convened a consensus conference to develop the Needs-Based Assessment of Trauma Systems (NBATS) tool to assist in determining the number of trauma centers required for a region. We tested the performance of NBATS with respect to the optimal number of trauma centers needed by region in California.MethodsTrauma center data were obtained from the California Emergency Services Authority Information Systems (CEMSIS). Numbers of admitted trauma patients (ISS > 15) were obtained using statewide nonpublic admissions data from the California Office of Statewide Health Planning and Development (OSHPD), CEMSIS, and data from local emergency medical service agency (LEMSA) directors who agreed to participate in a telephone survey. Population estimates per county for 2014 were obtained from the U.S. Census. NBATS criteria used included population, transport time, community support, and number of discharges for severely injured patients (ISS > 15) at nontrauma centers and trauma centers. Estimates for the number of trauma centers per region were created for each of the three data sources and compared to the number of existing centers.ResultsA total of 62 state-designated trauma centers were identified for California: 13 (21%) Level I, 36 (58%) Level II, and 13 (11%) Level III. NBATS estimates for the total number of trauma centers in California were 27% to 47% lower compared to the number of trauma centers in existence, but this varied based on urban/rural status. NBATS estimates were lower than the current state in 70% of urban areas but were higher in almost 90% of rural areas. All data sources (OSHPD, CEMSIS, local data) produced similar results.ConclusionEstimates from the NBATS tool are different from what is currently in existence in California, and differences exist based on whether the region is rural or urban. Findings from the current study can help inform future iterations of the NBATS tool.Level of evidenceEconomic, level V