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

Background: Increasing 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. Objective: To elucidate the current landscape of studies reporting data related to sDHT human factors, human-centered design, and/or usability. Methods: We 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. Results: Our 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, efficiency, 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). Conclusions: Based 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. ### Competing Interest Statement AT is a consultant for Synergen Technology Labs, LLC, Siemens Healthineers, and Gabi SmartCare. BRC is an employee of Genentech, a member of the Roche Group and Roche Pharmaceuticals, and owns company stock. EI is an employee of Koneksa Health, and may own company stock. NVM and SV are employees of Johnson & Johnson Innovative Medicine and hold company stocks or stock options. JPB reports financial interests (consulting income, shares, and/or stock) in Philips, Signifier Medical Technologies, Koneksa Health, and Apnimed. ES serves on the editorial board as associate editor of JMIR Publications. ### Funding Statement This work was undertaken within the Digital Health Measurement Collaborative Community (DATAcc), hosted by the Digital Medicine Society (DiMe). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors