JMIR Publications

ABSTRACT

Background:

Correct use of a pressurized metered-dose inhaler (pMDI), usually with a valved holding chamber, depends on use-related conditions that caregivers may not observe directly, including inhalation pattern, actuation-inhalation timing, mask seal, and device orientation. Many digital inhaler systems emphasize actuation or adherence. Systems that infer technique-related conditions from proxy signals may add real-time feedback but also create false reassurance if a positive state is displayed when evidence is inadequate. Caregiver expectations for such feedback and its failure states remain poorly characterized before prototype development.

Objective:

This study aimed to characterize caregivers' experiences of pediatric inhaler administration and translate responses to a proposed sensor concept into traceable candidate safety, system, and validation requirements.

Methods:

We conducted 23 semistructured concept-elicitation sessions by Zoom videoconference (19 individual and 4 dyadic sessions within households) with 27 caregivers of children who currently or previously used an inhaler. A 6-phase guide examined current practices, difficulties, prior digital-tool use, and responses to a screen-shared clip-on concept incorporating airflow-, timing-, seal-, and orientation-related sensing; on-device feedback; an optional child-facing app; and a caregiver dashboard. No working prototype was evaluated. Approximately 86,000 transcript words underwent hybrid directed and conventional qualitative content analysis using an 18-category codebook. A second researcher independently coded the complete 27×18 matrix (486 paired decisions) across 2 rounds. Consensus categories were translated into candidate requirements and assigned an earliest verification or evaluation locus. Counts are descriptive caregiver-voice tallies, not prevalence estimates.

Results:

Persistent uncertainty about whether administration conditions were adequate was the dominant lived experience (19/27), and existing passive cues did not resolve it (5/27). A simple, real-time on-device signal was widely endorsed (25/27), but willingness to consider the concept was conditional on avoiding false-positive reassurance (a “false green”; 9/27), low-friction operation during acute symptoms (12/27), minimal added bulk and technique change, and one or more of clinical validation, clinician recommendation, or a trial pathway (composite category; 23/27). Stances on gamification (20/27), dashboard cadence (18/27), aesthetics (24/27), and privacy (18/27) supported an optional, configurable software layer. Intercoder agreement was 94.0% (Cohen kappa=0.88). The analytic synthesis yielded a conceptual architecture separating observable proxy signals, an inference and data-quality gate, and positive, corrective, or uncertain feedback states.

Conclusions:

Caregivers prioritized immediate, interpretable feedback about validated use-related conditions, not proof that medication reached the lungs. The findings support conservative state assignment, an explicit uncertain state for indeterminate signals, and app-independent acute-use feedback. These are candidate requirements rather than validated device specifications; subsequent work should proceed through bench verification, simulated-use human factors evaluation, and prospective clinical or field validation.