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Technical validity and usability of a novel smartphone-connected spirometry device for pediatric patients with asthma and cystic fibrosis.

ABSTRACT: BACKGROUND:Diagnosis and follow-up of respiratory diseases traditionally rely on pulmonary function tests (PFTs), which are currently performed in hospitals and require trained personnel. Smartphone-connected spirometers, like the Air Next spirometer, have been developed to aid in the home monitoring of patients with pulmonary disease. The aim of this study was to investigate the technical validity and usability of the Air Next spirometer in pediatric patients. METHODS:Device variability was tested with a calibrated syringe. About 90 subjects, aged 6 to 16, were included in a prospective cohort study. Fifty-eight subjects performed conventional spirometry and subsequent Air Next spirometry. The bias and the limits of agreement between the measurements were calculated. Furthermore, subjects used the device for 28 days at home and completed a subject-satisfaction questionnaire at the end of the study period. RESULTS:Interdevice variability was 2.8% and intradevice variability was 0.9%. The average difference between the Air Next and conventional spirometry was 40?mL for forced expiratory volume in 1 second (FEV1) and 3?mL for forced vital capacity (FVC). The limits of agreement were -270?mL and +352?mL for FEV1 and -403 mL and +397?mL for FVC. About 45% of FEV1 measurements and 41% of FVC measurements at home were acceptable and reproducible according to American Thoracic Society/European Respiratory Society criteria. Parents scored difficulty, usefulness, and reliability of the device 1.9, 3.5, and 3.8 out of 5, respectively. CONCLUSION:The Air Next device shows validity for the measurement of FEV1 and FVC in a pediatric patient population.

SUBMITTER: Kruizinga MD

PROVIDER: S-EPMC7496177 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Technical validity and usability of a novel smartphone-connected spirometry device for pediatric patients with asthma and cystic fibrosis.

Kruizinga Matthijs D MD Essers Esmée E Stuurman F E FE Zhuparris Ahnjili A van Eik Nellie N Janssens Hettie M HM Groothuis Iris I Sprij Arwen J AJ Nuijsink Marianne M Cohen Adam F AF Driessen Gertjan J A GJA

Pediatric pulmonology 20200708 9

<h4>Background</h4>Diagnosis and follow-up of respiratory diseases traditionally rely on pulmonary function tests (PFTs), which are currently performed in hospitals and require trained personnel. Smartphone-connected spirometers, like the Air Next spirometer, have been developed to aid in the home monitoring of patients with pulmonary disease. The aim of this study was to investigate the technical validity and usability of the Air Next spirometer in pediatric patients.<h4>Methods</h4>Device vari ...[more]

PMID: 32592537

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Project description:BackgroundThe Smart Angel home medical device allows ambulatory surgery patients to monitor their own health by taking their blood pressure and oxygen levels and answering a health questionnaire from home. Currently, this device is a prototype in the design phase, and no usability evaluation has been performed. This preventive device must be usable by patients with different profiles; however, it is important to select patients carefully to ensure their safety when using the device. As such, it would be interesting to know how to select or exclude patients. However, the links between user characteristics and the usability of this home medical device remain unclear.ObjectiveThis study aims to better understand the links between certain characteristics of potential patients (ie, age, education, technophilia, and health literacy) and the usability (ie, effectiveness, efficiency, and satisfaction) of Smart Angel, as defined by the ISO 9241-11.MethodsWe conducted an experimental study involving 36 participants investigating the effects of 4 patient characteristics (ie, age, education, technophilia, and health literacy) on usability, measured in terms of effectiveness, efficiency, and satisfaction. A mixed methods approach (subjective vs objective) using a variety of standard instruments was adopted (direct observation, video analysis, and questionnaires). First, to help participants project themselves into the real use of the Smart Angel device, they watched a scenario in a video. Second, the participants completed a set of questionnaires to show the extent of their health literacy level (Newest Vital Sign [NVS] and the Health Literacy Survey [HLS]) and then operated Smart Angel devices. Efficiency (ie, handling time) and effectiveness (ie, number of handling errors) measures were collected by video analysis. Satisfaction measures were collected by a questionnaire (System Usability Scale [SUS]). The qualitative observational data were coded using inductive analysis by 2 independent researchers specialized in cognitive psychology and cognitive ergonomics.ResultsThe results show a moderate and positive correlation between age and effectiveness (r=0.359; P=.03) and efficiency (r=0.357; P=.03). There is strong correlation between health literacy scored by the NVS and effectiveness (r=0.417; P=.01), efficiency (r=-0.38; P=.02), and satisfaction (r=0.45; P=.006). However, there is a weak correlation between technophilia and usability and no relationship between education level and usability.ConclusionsOur results show that literacy level and age are 2 important factors to consider when selecting future users of the Smart Angel device to ensure patient safety. This study also serves as an example promoting mixed methodologies in assessments of medical device usability that cannot be performed under real-world conditions.

Project description:OBJECTIVE:The aim of this study was to design and evaluate a smartphone-based application for improving self-management in patients with asthma and evaluate its effects on their knowledge. METHODS:In this applied research, based on the Clinical Practice Guideline and a systematic review, a questionnaire was designed to determine the application information content and functionality requirements by 15 pediatric and adult asthma and allergy specialist. Then the application was designed and developed using Adobe Air software on the Android operating system. Usability evaluation of the mobile application was performed using the standard questionnaire for user interaction satisfaction (QUIS), which completed by 30 patients with asthma, 8 information technology (IT) specialists, and 2 asthma and allergy specialists. Self-management knowledge of 30 asthma patients was measured using a researcher-made questionnaire before and after using the application. RESULTS:The number of specialists in the both Delphi rounds was 15 and the mean work experiences were 17.6 years. The most important elements for asthma self-management were avoiding exposure to allergen and triggers (96%), drug treatment (94.6%), and how to use the therapeutic tools (92.4%), and the most important functionalities were alerting the patients when they did not control asthma (92%), setting reminders for timely drug use (85.4%) and therapeutic tools (82.6%), recording prescription drugs (82.6%), and peak flow meter values (82%). Usability evaluation showed that 30 patients with asthma, 8 IT specialists, and 2 physicians evaluated the application at a "good" level. The mean score of the patients' knowledge before intervention was 2.43?±?0.95 which after intervention was significantly increased to 4.3?±?0.56 (p?<?0.001). CONCLUSION:Considering the desirable outcomes of application evaluation and a positive impact of this educational intervention on asthma patients' knowledge, it is possible to use mobile-based self-management programs to help these patients to manage illness and gain knowledge and self-management skills.

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Technical validity and usability of a novel smartphone-connected spirometry device for pediatric patients with asthma and cystic fibrosis.

Publications

Technical validity and usability of a novel smartphone-connected spirometry device for pediatric patients with asthma and cystic fibrosis.

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