scholarly journals Identification of Patient Perceptions That Can Affect the Uptake of Interventions Using Biometric Monitoring Devices: Systematic Review of Randomized Controlled Trials (Preprint)

2020 ◽  
Author(s):  
Alexander Perlmutter ◽  
Mehdi Benchoufi ◽  
Philippe Ravaud ◽  
Viet-Thi Tran
Keyword(s):  
Randomized Controlled Trials ◽  
Real World ◽  
Glucose Monitoring ◽  
Median Number ◽  
Patient Perceptions ◽  
Controlled Trials ◽  
Data Handling ◽  
The Real ◽  
Randomized Controlled ◽  
Monitoring Devices

BACKGROUND Biometric 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. OBJECTIVE We aimed to systematically review whether and how recent randomized controlled trials (RCTs) evaluating interventions using BMDs assessed patients’ perceptions toward the intervention. METHODS We 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. RESULTS A 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. CONCLUSIONS Our 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. CLINICALTRIAL PROSPERO CRD42018115522; https://tinyurl.com/y5h8fjgx

scholarly journals Identification of Patient Perceptions That Can Affect the Uptake of Interventions Using Biometric Monitoring Devices: Systematic Review of Randomized Controlled Trials

10.2196/18986 ◽  
2020 ◽  
Vol 22 (9) ◽  
pp. e18986
Author(s):  
Alexander Perlmutter ◽  
Mehdi Benchoufi ◽  
Philippe Ravaud ◽  
Viet-Thi Tran
Keyword(s):  
Randomized Controlled Trials ◽  
Real World ◽  
Glucose Monitoring ◽  
Median Number ◽  
Patient Perceptions ◽  
Controlled Trials ◽  
Data Handling ◽  
The Real ◽  
Randomized Controlled ◽  
Monitoring Devices

Background Biometric 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. Objective We aimed to systematically review whether and how recent randomized controlled trials (RCTs) evaluating interventions using BMDs assessed patients’ perceptions toward the intervention. Methods We 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. Results A 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. Conclusions Our 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 Registration PROSPERO CRD42018115522; https://tinyurl.com/y5h8fjgx

scholarly journals Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience

2021 ◽  
Vol 14 ◽  
pp. 175628482110106
Author(s):  
Fabio Salvatore Macaluso ◽  
Marcello Maida ◽  
Mauro Grova ◽  
Federica Crispino ◽  
Giulia Teresi ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Randomized Controlled Trials ◽  
Real World ◽  
Bowel Disease ◽  
Quality Data ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Therapeutic Algorithms ◽  
Inflammatory Bowel

During past years, the increasing knowledge of molecular mechanisms of inflammatory bowel disease (IBD) have led to the development of several targeted biological therapies. This great expansion of available medical options has prompted the need for comparative data between drugs. For years, given that most randomized controlled trials (RCTs) were performed only versus placebo, this demand has clashed with the absence of head-to-head trials comparing two or more treatments. The quality of evidence coming from real-world experience was low overall, so it was extremely difficult to clarify the correct positioning of the biologicals inside the therapeutic algorithms for IBD. Fortunately, times are changing: head-to-head comparative RCTs have been conducted or are ongoing, and the methodological quality of real-world studies is gradually increasing, mainly thanks to a higher rate of application of statistical methods capable of reducing the selection bias, such as the propensity score. In this evolving scenario, the increasing number of comparative RCTs is providing high-quality data for a correct drug positioning in IBD. In parallel, real-world observational studies are supporting the data coming from RCTs, and covering those comparisons not performed in the RCT setting. We believe that there is moderate evidence already available to support clinicians in the correct choice between different biologicals, and data will certainly be more robust in the near future.

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