A systematic scoping review of studies describing human factors, human-centered design, and usability of sensor-based digital health technologies

BackgroundIncreasing adoption of sensor-based digital health technologies (sDHTs) in recent years has cast light on the many challenges in implementing these tools into clinical trials and patient care at scale across diverse patient populations; however, the methodological approaches taken towards sDHT usability evaluation have varied markedly. ObjectiveTo elucidate the current landscape of studies reporting data related to sDHT human factors, human-centered design, and/or usability. MethodsWe conducted a systematic scoping review of studies published between 2013 and 2023 and indexed in PubMed, in which data related to sDHT human factors, human-centered design, and/or usability were reported. Following a systematic screening process, we extracted the study design; participant sample; the sDHT(s) used; the method(s) of data capture; and the type(s) of usability-related data captured. ResultsOur literature search returned 442 papers, of which 85 were found to be eligible and 83 were available for data extraction and not under embargo. In total, 164 sDHTs were evaluated; 141 were wearable tools while the remaining 23 were ambient tools. The majority of studies (n=55; 66%) reported summative evaluations of final-design sDHTs. Almost all studies (n=82; 98%) captured data from targeted end-users, but only 18 (22%) captured data from additional users such as carepartners or clinicians. User satisfaction and ease of use were evaluated for >80% of sDHTs; however, learnability, eficiency, and memorability were reported for only 11 (13%), 4 (5%), and 2 sDHTs (2%), respectively. Fourteen sDHTs (17%) were evaluated according to the extent to which users were able to understand the clinical data or other information presented to them (understandability) and/or the actions or tasks they should complete in response (actionability). Notable gaps in reporting included the absence of a sample size rationale (reported for 25% of all studies and 31% of summative studies) and incomplete sociodemographic descriptive data (complete age, sex/gender, and race/ethnicity reported for 17% of studies). ConclusionsBased on our findings, we suggest four actionable recommendations for future studies that will help to advance the implementation of sDHTs: 1) Consider in-depth assessment of technology usability beyond user satisfaction and ease of use; 2) Expand recruitment to include important user groups such as clinicians and carepartners; 3) Report the rationale for key study design considerations including the sample size; and 4) Provide rich descriptive statistics regarding the study sample to allow a complete understanding of generalizability to other patient populations and contexts of use.