Patient perception of Breezhaler® and Ellipta® device feedback mechanisms in COPD: The ADVANTAGE Study.

OBJECTIVES: The primary objective of the ADVANTAGE study was to compare device-naïve chronic obstructive pulmonary disease (COPD) patients' perception of the Breezhaler® and Ellipta® devices' feedback mechanisms of dose delivery confirmation. The secondary objective was to assess comfort with the inhalers' mouthpiece in terms of ease to form a tight seal around the mouthpiece. These objectives were achieved by using a novel, patient perception of inhaler questionnaire developed and tested during cognitive interviews of patients by Evidera, London, United Kingdom. METHODS: Ten COPD patients were interviewed to collect feedback on the interpretation, relevance and language of the questionnaire. This questionnaire was then used in ADVANTAGE to compare patients' perception (n = 100) of both devices. Patients completed the questionnaire after a single inhalation of placebo through each inhaler. RESULTS: Using the final questionnaire, patients reported being more confident of the feedback mechanism of Breezhaler than that of the Ellipta device (mean score 4.3 versus 3.6 respectively, estimated difference [95% CI]: 0.75 [0.51, 0.99], p < .0001). Patients also reported better comfort (ease to form a tight seal with the lips) with the Breezhaler mouthpiece than the Ellipta mouthpiece (mean score 4.3 versus 3.9 respectively, estimated difference [95% CI]: 0.41 [0.21, 0.61], p < .0001). There were no safety concerns associated with either device. CONCLUSION: COPD patients showed greater preference for the Breezhaler over the Ellipta inhaler for confidence of dose delivery and comfort of the mouthpiece. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov (ClinicalTrials.gov number NCT02551224).

Development of a simple binary response questionnaire to identify airflow obstruction in a smoking population in Argentina.

The CODE questionnaire (COPD detection questionnaire), a simple, binary response scale (yes/no), screening questionnaire, was developed for the identification of patients with chronic obstructive pulmonary disease (COPD). We conducted a survey of 468 subjects with a smoking history in 10 public hospitals in Argentina. Patients with a previous diagnosis of COPD, asthma and other respiratory illness were excluded. Items that measured conceptual domains in terms of characteristics of symptoms, smoking history and demographics data were considered. 96 (20.5%) subjects had a diagnosis of COPD according to the 2010 Global Initiative for Chronic Obstructive Lung Disease strategy document. The variables selected for the final questionnaire were based on univariate and multivariate analyses and clinical criteria. Finally, we selected the presence or absence of six variables (age ≥50 years, smoking history ≥30 pack-years, male sex, chronic cough, chronic phlegm and dyspnoea). Of patients without any of these six variables (0 points), none had COPD. The ability of the CODE questionnaire to discriminate between subjects with and without COPD was good (the area under the receiver operating characteristic curve was 0.75). Higher scores were associated with a greater probability of COPD. The CODE questionnaire is a brief, accurate questionnaire that can identify smoking individuals likely to have COPD.

Sleep disordered breathing and daytime sleepiness are associated with poor academic performance in teenagers. A study using the Pediatric Daytime Sleepiness Scale (PDSS).

STUDY OBJECTIVES: Inadequate sleep and sleep disordered breathing (SDB) can impair learning skills. Questionnaires used to evaluate sleepiness in adults are usually inadequate for adolescents. We conducted a study to evaluate the performance of a Spanish version of the Pediatric Daytime Sleepiness Scale (PDSS) and to assess the impact of sleepiness and SDB on academic performance. DESIGN: A cross-sectional survey of students from 7 schools in 4 cities of Argentina. MEASUREMENTS: A questionnaire with a Spanish version of the PDSS was used. Questions on the occurrence of snoring and witnessed apneas were answered by the parents. Mathematics and language grades were used as indicators of academic performance. PARTICIPANTS: The sample included 2,884 students (50% males; age: 13.3 +/- 1.5 years) RESULTS: Response rate was 85%; 678 cases were excluded due to missing data. Half the students slept <9 h per night on weekdays. The mean PDSS value was 15.74 +/- 5.93. Parental reporting of snoring occurred in 511 subjects (23%); snoring was occasional in 14% and frequent in 9%. Apneas were witnessed in 237 cases (11%), being frequent in 4% and occasional in 7%. Frequent snorers had higher mean PDSS scores than occasional or nonsnorers (18 +/- 5, 15.7 +/- 6 and 15.5 +/- 6, respectively; P < 0.001). Reported snoring or apneas and the PDSS were significant univariate predictors of failure and remained significant in multivariate logistic regression analysis after adjusting for age, sex, body mass index, specific school attended, and sleep habits. CONCLUSIONS: Insufficient hours of sleep were prevalent in this population. The Spanish version of the PDSS was a reliable tool in middle-school-aged children. Reports of snoring or witnessed apneas and daytime sleepiness as measured by PDSS were independent predictors of poor academic performance.