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Use of wearable biometric monitoring devices to measure outcomes in randomized clinical trials: a methodological systematic review.

ABSTRACT: BACKGROUND:Wearable biometric monitoring devices (BMDs) have the potential to transform the conduct of randomized controlled trials (RCTs) by shifting the collection of outcome data from single measurements at predefined time points to dense continuous measurements. METHODS:Methodological systematic review to understand how recent RCTs used BMDs to measure outcomes and to describe the reporting of these RCTs. Electronic search was performed in the Cochrane Central Register of Controlled Trials, PubMed, and EMBASE and completed a page-by-page hand search in five leading medical journals between January 1, 2018, and December 31, 2018. Three reviewers independently extracted all primary and secondary outcomes collected using BMDs, and assessed (1) the definitions used to summarize BMD outcome data; (2) whether the validity, reliability, and responsiveness of sensors was reported; (3) the discrepancy with outcomes prespecified in public clinical trial registries; and (4) the methods used to manage missing and incomplete BMD outcome data. RESULTS:Of the 4562 records screened, 75 RCTs were eligible. Among them, 24% tested a pharmacological intervention and 57% used an inertial measurement sensor to measure physical activity. Included trials involved 464 outcomes (average of 6 [SD?=?8] outcomes per trial). In total, 35 trials used a BMD to measure a primary outcome. Several issues affected the value and transparency of trials using BMDs to measure outcomes. First, the definition of outcomes used in the trials was highly heterogeneous (e.g., 21 diabetes trials had 266 outcomes and 153 had different unique definitions to measure diabetes control), which limited the combination and comparison of results. Second, information on the validity, reliability, and responsiveness of sensors used was lacking in 74% of trials. Third, half (53%) of the outcomes measured with BMDs had not been prespecified, with a high risk of outcome reporting bias. Finally, reporting on the management of incomplete outcome data (e.g., due to suboptimal compliance with the BMD) was absent in 68% of RCTs. CONCLUSIONS:Use of BMDs to measure outcomes is becoming the norm rather than the exception in many fields. Yet, trialists need to account for several methodological issues when specifying and conducting RCTs using these novel tools.

SUBMITTER: Grana Possamai C

PROVIDER: S-EPMC7646072 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Use of wearable biometric monitoring devices to measure outcomes in randomized clinical trials: a methodological systematic review.

Graña Possamai Carolina C Ravaud Philippe P Ghosn Lina L Tran Viet-Thi VT

BMC medicine 20201106 1

<h4>Background</h4>Wearable biometric monitoring devices (BMDs) have the potential to transform the conduct of randomized controlled trials (RCTs) by shifting the collection of outcome data from single measurements at predefined time points to dense continuous measurements.<h4>Methods</h4>Methodological systematic review to understand how recent RCTs used BMDs to measure outcomes and to describe the reporting of these RCTs. Electronic search was performed in the Cochrane Central Register of Cont ...[more]

PMID: 33153462

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Project description:BackgroundBiometric monitoring devices (BMDs) are wearable or environmental trackers and devices with embedded sensors that can remotely collect high-frequency objective data on patients' physiological, biological, behavioral, and environmental contexts (for example, fitness trackers with accelerometer). The real-world effectiveness of interventions using biometric monitoring devices depends on patients' perceptions of these interventions.ObjectiveWe aimed to systematically review whether and how recent randomized controlled trials (RCTs) evaluating interventions using BMDs assessed patients' perceptions toward the intervention.MethodsWe systematically searched PubMed (MEDLINE) from January 1, 2017, to December 31, 2018, for RCTs evaluating interventions using BMDs. Two independent investigators extracted the following information: (1) whether the RCT collected information on patient perceptions toward the intervention using BMDs and (2) if so, what precisely was 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.ResultsA total of 58 RCTs including 10,071 participants were included in the review (the median number of randomized participants was 60, IQR 37-133). BMDs used in interventions were accelerometers/pedometers (n=35, 60%), electrochemical biosensors (eg, continuous glucose monitoring; n=18, 31%), or ecological momentary assessment devices (eg, carbon monoxide monitors for smoking cessation; n=5, 9%). Overall, 26 (45%) trials collected information on patient perceptions toward the intervention using BMDs and allowed the identification of 76 unique aspects of patient perceptions that could affect the uptake of these interventions (eg, 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% (n=3) of trials assessed how patients felt about privacy and data handling aspects of the intervention using BMDs.ConclusionsOur review showed that less than half of RCTs evaluating interventions using BMDs assessed patients' perceptions toward interventions using BMDs. Trials that did assess perceptions often only assessed a fraction of them. This limits the extrapolation of the 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.Trial registrationPROSPERO CRD42018115522; https://tinyurl.com/y5h8fjgx.

Project description:BackgroundWearable devices can be used for continuous patient monitoring in the general ward, increasing patient safety. Little is known about the experiences and expectations of patients and health care professionals regarding continuous monitoring with these devices.ObjectiveThis study aimed to identify positive and negative effects as well as barriers and facilitators for the use of two wearable devices: ViSi Mobile (VM) and HealthPatch (HP).MethodsIn this randomized controlled trial, 90 patients admitted to the internal medicine and surgical wards of a university hospital in the Netherlands were randomly assigned to continuous vital sign monitoring using VM or HP and a control group. Users' experiences and expectations were addressed using semistructured interviews. Nurses, physician assistants, and medical doctors were also interviewed. Interviews were analyzed using thematic content analysis. Psychological distress was assessed using the State Trait Anxiety Inventory and the Pain Catastrophizing Scale. The System Usability Scale was used to assess the usability of both devices.ResultsA total of 60 patients, 20 nurses, 3 physician assistants, and 6 medical doctors were interviewed. We identified 47 positive and 30 negative effects and 19 facilitators and 36 barriers for the use of VM and HP. Frequently mentioned topics included earlier identification of clinical deterioration, increased feelings of safety, and VM lines and electrodes. No differences related to psychological distress and usability were found between randomization groups or devices.ConclusionsBoth devices were well received by most patients and health care professionals, and the majority of them encouraged the idea of monitoring vital signs continuously in the general ward. This comprehensive overview of barriers and facilitators of using wireless devices may serve as a guide for future researchers, developers, and health care institutions that consider implementing continuous monitoring in the ward.Trial registrationClinicaltrials.gov NCT02933307; http://clinicaltrials.gov/ct2/show/NCT02933307.

Project description:Abstract Aims High blood pressure (BP) is the commonest modifiable cardiovascular risk factor, yet its monitoring remains problematic. Wearable cuffless BP devices offer potential solutions; however, little is known about their validity and utility. We aimed to systematically review the validity, features and clinical use of wearable cuffless BP devices. Methods and results We searched MEDLINE, Embase, IEEE Xplore and the Cochrane Database till December 2019 for studies that reported validating cuffless BP devices. We extracted information about study characteristics, device features, validation processes, and clinical applications. Devices were classified according to their functions and features. We defined devices with a mean systolic BP (SBP) and diastolic BP (DBP) biases of <5 mmHg as valid as a consensus. Our definition of validity did not include assessment of device measurement precision, which is assessed by standard deviation of the mean difference—a critical component of ISO protocol validation criteria. Study quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies version 2 tool. A random-effects model meta-analysis was performed to summarise the mean biases for SBP and DBP across studies. Of the 430 studies identified, 16 studies (15 devices, 974 participants) were selected. The majority of devices (81.3%) used photoplethysmography to estimate BP against a reference device; other technologies included tonometry, auscultation and electrocardiogram. In addition to BP and heart rate, some devices also measured night-time BP (n = 5), sleep monitoring (n = 3), oxygen saturation (n = 3), temperature (n = 2) and electrocardiogram (n = 3). Eight devices showed mean biases of <5 mmHg for SBP and DBP compared with a reference device and three devices were commercially available. The meta-analysis showed no statistically significant differences between the wearable and reference devices for SBP (pooled mean difference = 3.42 mmHg, 95% CI: −2.17, 9.01, I2 95.4%) and DBP (pooled mean = 1.16 mmHg, 95% CI: −1.26, 3.58, I2 87.1%). Conclusion Several cuffless BP devices are currently available using different technologies, offering the potential for continuous BP monitoring. The variation in standards and validation protocols limited the comparability of findings across studies and the identification of the most accurate device. Challenges such as validation using standard protocols and in real-life settings must be overcome before they can be recommended for uptake into clinical practice. Graphical Abstract Graphical abstract Wearable BP device system.

Project description:BackgroundThere are many problems with fitness trackers, such as device usability, which limit their large-scale application, and relevant studies are limited in terms of their sample size and evaluation methods. The purpose of the study was to evaluate the perceived usability of various mainstream fitness trackers on the market, and to learn about user feedback on feature preferences for each device.MethodsTrial use of seven mainstream fitness trackers (two smart watches and five smart wristbands) followed by a survey study were applied. The questionnaire was specifically developed for this study, which included two parts (user preferences and device usability in five dimensions). We recruited users to test the devices for at least 30 days and asked experienced users to provide feedback in order to evaluate each device, including the rating and user preference of each device.ResultsWe received 388 valid questionnaires, in which users rated their responses on a five-point Likert scale. (1) User preference: the average user satisfaction was 3.50-3.86 (points), and the rating for willingness to buy averaged between 3.36 and 3.59. More users were willing to wear (58.3-81.3%) and purchase (56.8-83.0%) the devices than were not. The top three general feature preferences were daily activity tracking, heart health monitoring, and professional fitness tracking. The top three health-related feature preferences were heart rate monitoring, daily pedometer, and professional fitness tracking. (2) Usability evaluation: product design was rated from 3.57 to 4.00; durability, 3.63-4.26; ease of use, 3.70-3.90; added features, 3.30-3.83; and user-rated accuracy, 3.44-3.78. A significant difference was observed in the rating of product design and durability among the different devices (p < 0.05) score.ConclusionsUsers generally had positive subjective intent regarding fitness trackers but were less satisfied with their cost effectiveness. The users preferred health related features such as heart health monitoring, and professional fitness tracking. The rating of most of the current mainstream fitness trackers was fair with some significant differences among the devices. Thus, further improvement is needed.

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Use of wearable biometric monitoring devices to measure outcomes in randomized clinical trials: a methodological systematic review.

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Use of wearable biometric monitoring devices to measure outcomes in randomized clinical trials: a methodological systematic review.

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