Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Wearable Fitbit activity trackers are increasingly being used as outcome measurement tools in research and to inform healthcare decisions. However, the accuracy of these devices has not been systematically evaluated. Objective: To quantify Fitbit device measurement accuracy in controlled and free-living settings. Methods: Electronic searches using PubMed, Embase, CINAHL and SportsDiscus databases with a supplementary Google Scholar search. Original research published in English comparing Fitbit device measurements to a gold- or research-standard criterion in adults living with any health, disease or functional status. Risk of bias was assessed using a modified validation subscale in the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN). We identified and synthesized percent measurement error estimates for Fitbit measures of steps, energy expenditure (EE), sleep, distance and time in activity. Results: 67 studies met the inclusion criteria, with 57 incorporated in the quantitative syntheses. Respectively, 40, 21, 8, 6 and 2 studies included measures of steps, EE, time in activity, sleep and distance. Fitbit devices demonstrated acceptable accuracy in controlled settings (Mean % error: +/-3%) for measures of steps taken at normal, jogging and very slow walking speeds when worn on the torso, wrist and ankle respectively, and acceptable accuracy for measures of EE at rest and during very slow walking and for distance measures at normal walking speeds when worn on the wrist. Notable inaccuracies in controlled settings were underestimations of steps during household or sporting activities (Mean: -35.4%; SD: 20.5%) or when using a walking aid (Mean: -20.9%; SD: 22.4%), and underestimations of EE during inclined ambulation (Mean: -18.7%; SD: 22.2%) and overestimations of EE for walking on flat surfaces (Mean: 16.7%; SD: 31.4%). In free-living settings, Fitbit demonstrated acceptable relative accuracy (Mean % error: +/-10%) compared to a research-standard criterion for measures of daily steps when worn on the torso, as well as measures of time in bed and total EE over 15 days. Notable relative inaccuracies in free-living settings were mean error overestimations varying from 30% to 600% for time spent in light through vigorous activity and underestimation of daily steps in mobility-limited older adults (Mean: -24.3%; SD: 9.0%). Conclusions: Other than measures of steps during typical walking activities and EE at rest and across a number of days, the Fitbit activity trackers reviewed showed limited measurement accuracy in both controlled and free-living settings. Given the current limitations of Fitbit’s measurement accuracy, discretion should be exercised when using these devices as an outcome measurement tool in research or to inform healthcare decisions. Clinical Trial: N/A