JMIR Publications

ABSTRACT

Background:

The real-world effectiveness of interventions using Biometric Monitoring Devices (BMDs) (i.e. interventions using wearable or environmental devices to collect remote and continuous data to guide care) depends on patients’ perceptions of these interventions.

Objective:

We aimed to systematically review whether and how recent randomized controlled trials (RCTs) evaluating interventions using BMDs assessed patients’ perceptions towards the intervention.

Methods:

We systematically searched PubMed (MEDLINE), from 1 January 2017, to 31 December 2018, for RCTs evaluating interventions using BMDs. Two independent investigators extracted 1) whether the RCT collected information on patient perceptions toward the intervention using BMDs and, 2) if so, what was precisely collected, based on items from questionnaires used and/or themes and subthemes identified from qualitative assessments. The two investigators then synthesized their findings in a schema of patient perceptions of interventions using BMDs.

Results:

A total of 58 RCTs including 10 071 participants were included in the review (median number of randomized participants: 60, interquartile range [37-133]). BMDs used in interventions were accelerometers/pedometers (60%), electrochemical biosensors (e.g., continuous glucose monitoring) (31%), or ecological momentary assessment devices (e.g., carbon monoxide monitors for smoking cessation) (9%). Twenty-six (45%) trials collected information on patient perceptions towards the intervention using BMDs and allowed the identification of 76 unique specific aspects of patient perceptions that could affect the uptake of these interventions (e.g., relevance of the information provided, alarm burden, privacy and data handling, impact on health outcomes, independence, interference with daily life). Patient perceptions were unevenly collected in trials. For example, only 5% of trials assessed how patients felt about privacy and data handling aspects of the intervention using BMDs.

Conclusions:

Our review showed that less than half of RCTs evaluating interventions using BMDs assessed patients’ perceptions towards interventions using BMDs. Trials which did often only assessed a fraction of these perceptions. This limits the extrapolation of results of these RCTs to the real world. We thus provide a comprehensive schema of aspects of patient perceptions that may affect the uptake of interventions using BMDs and which should be considered in future trials. Clinical Trial: Prospero: CRD42018115522