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Assessing the utility of wearable fitness trackers for objective capture and quantification of activity levels among patients undergoing radical cystectomy

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Assessing the utility of wearable fitness trackers for objective capture and quantification of activity levels among patients undergoing radical cystectomy

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Content 1
Assessing the Utility of Wearable Fitness Trackers for Objective Capture and Quantification of Activity
Levels Among Patients Undergoing Radical Cystectomy

Daniel E. Zainfeld, Madeleine L. Burg, Shane M. Pearce, Saum Ghodoussipour, Zhoobin H. Bateni, Ankeet Shah,
Anne Schuckman, Hooman Djaladat, Siamak Daneshmand

USC Institute of Urology, University of Southern California, Los Angeles, CA

Master of Science (Clinical, Biomedical, and Translational Investigations)
University of Southern California
December 2018

2
Table of Contents

Title Page ……… …… … … …… …… … …… … …. … …… ……… … …… … …… … … … ……… … …… …1
Table of Contents … …. … … … ……… …… … …. …… …… … ……… ……… ……… … … ………… ……..2
Abstract …… …… … … …… … ……… …… … …… … … … …… …… … …… … …… … … …... ………… …3
Introduction … … …… … … …… …… … …… … …. … …… ……… … …… … …… … … … ……… … …… …4
Methods … …… … … … … … …… …… ……… ……… … … …… …… … …… … …… … …... …… ……….4-5
Results …… … …… … …… … …… …… … …… … …… …… … ……… ……… ……… … … ………… ……..5
Discussion … …… … … … … … …… … ……… ……… … … ………… ……… ……… …… ……... … ……..5-6
Conclusion …… … … …… … …… …… ……… ……… … … …… …… … …… … …… … … …… ….. ……..6-7
References … … …… … …… … …… … ……… ……… …… ……… … …… … …… … … … ……… … …... ….8
Tables ……… ……… … …… … ……… …… … …… … … … …… …… … …… … …… … … …… ……... … …9

3
ABSTRACT

Background/Introduction: Wearable fitness trackers (WFTs) offer a novel method for objective evaluation and
quantification of patient behavioral patterns. We sought to determine capacity for use of these devices to measure
patient activity and sleep levels in the perioperative setting among patients undergoing radical cystectomy for bladder
cancer.

Methods: Under IRB approval, patients undergoing open or robotic RC were prospectively identified and consenting
patients given a WFT for continuous use up to 2 weeks preoperatively, in the immediate postoperative period, and up
to 2 weeks after discharge until first follow-up visit. Activity was automatically recorded and measured including total
daily steps, calories burned, and sedentary hours. Sleep outcomes included total daily hours asleep and number of
awakenings while sleeping. Delayed return of bowel function (dROBF) was defined as first bowel movement on
postoperative day 3 or greater.

Results: 34 patients were given a WFT for a median of 16 days total (IQR 11-22). Evaluable data was successfully
retrieved from all patients. Exploratory analysis indicates relationship between daily inpatient steps below median
427.5 and non-home discharge disposition (p=0.033), as well as daily preoperative calories below median 2,052 and
length of stay >6 days (p=0.029).

Conclusion: Use of WFT to objectively measure patients’ activity, sleep, and other physiologic variables is feasible
among patients undergoing radical cystectomy. Ongoing evaluation will provide further insights into patient functional
status with implications for risk stratification, discharge planning, and perioperative management among patients
undergoing radical cystectomy.

4
INTRODUCTION
Risk stratification among patients undergoing high risk surgical procedures is essential for the prediction and
identification of perioperative complications as well as the guidance of perioperative care. Further, effective
techniques for risk stratification may inform decisions for appropriate treatments among individual patients.
Therefore, significant attention has been directed to the development and validation of various tools to assist
clinicians in this arena(1).

Within the field of urologic oncology, radical cystectomy with urinary diversion is the standard therapy for muscle-
invasive urothelial carcinoma, yet remains a highly morbid operation associated with significant rates of
complications, readmissions, and a lengthy recovery process even among modern cohorts with application of
enhanced recovery after surgery (ERAS) protocols(2,3). Rates of perioperative complications have been reported
ranging from 28% to 64% and noted to be even higher when among elderly populations(4,5). Despite efficacy in
treating bladder cancer, radical cystectomy has been shown to be underutilized(6). Reasons for this are unclear but
may relate to concerns regarding patient suitability for surgery and hesitancy to offer definitive treatment to some
patients deemed poor surgical candidates. Therefore, tools for identification of individuals in whom surgical
management is appropriate are needed, as are methods for care optimization prior to and following surgical
intervention.

Unfortunately, robust clinically applicable methods for this assessment are lacking. The clinical syndrome of frailty
has been demonstrated to correlate with outcomes among patients who underwent radical cystectomy and other
surgical procedures(4). However, predictive capacity of various frailty indices for high grade complications and
discharge destination is extremely limited and no risk stratification tools have been adopted to common clinical
practice(7). Instead, many clinical decisions are currently based on clinician gestalt derived from limited patient
encounter and exam. Objective evaluation beyond laboratory values and vital signs may greatly enhance the
capacity of physicians to appropriately assess patients, guide therapy, and counseling.

Wearable devices are now commercially available across a variety of platforms and are popular tools for personal
monitoring of movement, heart rate, sleep, and other variables(8). Despite popularity and widespread use among the
general population, these devices have not been formally implemented into standard clinical practice. Potential
limitations include associated cost, patient compliance, logistics of data acquisition, and clinical relevance of
collected data, which has not been definitively established. Potential benefits of objectively captured patient data are
myriad.

A systematic review evaluating wearable fitness trackers found high validity for step counts as well as interdevice
reliability for steps, distance, energy expenditure, and sleep (9). In addition, wearable fitness trackers have been
validated as objective measures of mobility during hospitalization and are being studied in other clinical contexts
including detection of cardiac arrhythmias(10–12). In the context of surgical procedures, evaluation of the utility of
wearable fitness trackers to capture clinically meaningful data has not been performed previously.
We sought to evaluate the feasibility and utility of wearable fitness tracker use among patients undergoing radical
cystectomy for urothelial carcinoma.

METHODS
Patients with urothelial carcinoma planned to undergo open or robotic radical cystectomy at a single center were
prospectively identified. Under institutional IRB approval, all mobile patients were offered participation in the study
contingent on simultaneous participation in an institutional IRB approved radical cystectomy database. Consenting
patients were assigned a wearable fitness tracker (Fitbit AltaHR devices - www.fitbit.com) at time of their pre-
operative appointment and instructed on appropriate use. No additional written information or instruction was
provided.

Devices were collected immediately prior to surgery for capture of preoperative activity and replaced immediately
after radical cystectomy. They were then worn continuously during hospitalization and following discharge. Devices
were retrieved at time of first post-operative visit or at time of discharge if patient elected to discontinue
participation.

Activity is automatically captured by the device and requires no additional user input. Captured data including total
daily steps, calories burned, and sedentary hours was analyzed. In addition, sleep outcomes including time slept each
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day for cycles >1 hour are captured. For each sleep cycle, minutes asleep and awake, number of awakenings, and
minutes in bed are recorded. Captured data was stored within the device and was retrieved at time of device
collection or daily during inpatient period of study.

Clinical outcomes were collected and analyzed within the context of a prospectively maintained institutional radical
cystectomy database. Exploratory data analysis was completed evaluating for trends in time to return of bowel
function, length of hospitalization, discharge disposition, and perioperative complications with respect to daily step
counts, sleep duration, sedentary time, and calories as recorded by the tracker. No direct interventions or specific
step goals were provided to patients. All statistical analysis was performed using STATA®, version 13 (Statacorp,
College Station, TX). Comparison of means was performed using Student’s t-test and comparison of medians was
performed using the Kruskal-Wallis test. Chi-squared tests were used for comparison of categorical variables. A
two-tailed p < 0.05 was the threshold for statistical significance.

RESULTS
A total of 37 patients were identified undergoing radical cystectomy within the study period and offered
participation. Of these, three patients refused participation in the study (reasons not specified). Among 34
consenting patients, data collection was successful from all patients in the immediate post-operative period. Median
age of participating subjects was 74 years (interquartile range [IQR] 64-80) with 69% male. 14 patients (41.2%)
received a continent urinary diversion. 7 (21.9%) were discharged to a skilled nursing facility (SNF). (Table 1)

22 (65%) patients wore the device for variable durations pre-operatively as well allowing capture of patient
information in that setting. Following discharge, 25 (74%) patients elected to continue device use while nine patients
(26%) chose to discontinue participation. Among those electing to not continue, most commonly cited reason was
concern for device responsibility. Despite wearing the device, two patients (6%) failed to charge it appropriately
prior to follow-up resulting in partial data collection over that period. No complications associated with device use
were encountered. All patients were able to wear the wrist-based tracker during their inpatient stay without difficulty
despite intravenous lines and other monitors.

Overall, median days of WFT use was 16 (IQR11-22). The majority of collected data was from the post-discharge
period where median days of WFT use was 7 (IQR 1-8).

Median preoperative daily step count was 4,432 steps (IQR 2,612-5,541), which decreased to 428 daily steps (IQR
263-769) in the inpatient setting and 838 daily steps (IQR 735-1,333) at time of postoperative follow-up. Sedentary
hours decreased from 15.35 per day (IQR 11.00-19.46) in the preoperative setting to 13.91 hours per day (IQR 8.29-
18.43) in the inpatient setting. Following discharge, however, patients were found to have increased sedentary time
of 17.61 hours per day (IQR 15.00-21.00). Calories burned, hours of sleep per 24-hour period, and awakenings per
hours asleep are also reported (Table 2).

Exploratory analysis compared WFT metrics by patient characteristics including age (<80 vs ≥80), urinary diversion
(continent vs incontinent), and clinical outcomes such as dROBF (>POD2), prolonged length of stay (>6 days), and
discharge disposition (home vs SNF).

When analyzed in context of available clinical outcomes, no significant relationship was determined between daily
inpatient step counts, sedentary time, or sleep patterns and dROBF. Daily inpatient step counts below the median
(428 steps/day) was associated with discharge to a skilled nursing facility (p=0.033), as was daily inpatient calories
burned below median (1841 cal/day).

Preoperative daily calories burned below the median of 2052 cal/day was associated with prolonged length of
hospitalization (p=0.029), while preoperative step count and sedentary time were not significantly associated with
clinical outcomes. There was no association between diversion type and any metric collected by the WFT.

DISCUSSION
Wearable fitness trackers are firmly established in popular culture and represent a multibillion-dollar industry which
continues to grow with focused efforts towards integration into healthcare. However, clinical applications remain
extremely limited. Our study demonstrates feasibility for use of these devices among a surgical population. Indeed,
patients undergoing radical cystectomy represent a particularly difficult demographic for implementation of new
6
technology given a generally older age, multiple medical comorbidities, and a complex surgical intervention.
Among patients in our study, median age was 74 (IQR 64-80). However, acceptance of the device and participation
in our study exceeded 90% as 34/37 patients offered chose to participate. This is in accordance with a published
survey of perception and acceptance of wearable technology for health monitoring specifically among a urological
patient population in which 82% of responders reported willingness to use activity monitors for medical care(13).

In the immediate postoperative setting, device acceptance and data capture were completed without significant
difficulty as devices are easily available to researchers for data retrieval and device charging as needed. Outside of
the hospital setting, however, application of WFTs is more problematic due to logistic issues that arise with
extended use. Particularly over extended periods of time, inherent limitations in the devices including battery power
and internal storage capacity become apparent as patients must charge and sync devices to maintain use.

Consent for study participation and assignment of device occurred at preoperative visit after prior decision for
surgery when possible. As some patients were not seen for repeat clinic visit prior to day of surgery, opportunity for
preoperative data collection was not feasible in all patients. In similar fashion, distribution of WFTs presents a
challenge when considering future efforts towards expanded data collection periods.

A number of patients elected not to continue use of the device postoperatively. Of those who did continue use, two
patients failed to charge the device resulting in incomplete data capture. Though increased complexity such as
charging of devices and data syncing requirements may increase hesitancy or noncompliance among patients, these
challenges can be addressed with improved education and support. In the present study, no written instructions or
specific structured training was provided to patients regarding optimal device use. Therefore, current results reflect a
bare minimum in terms of patient education and involvement yet resulted in fairly consistent data collection.
Expansion of study to include longer time periods would require patient intervention to sync data through use of a
mobile application or other means, potentially limiting generalizability of use patterns but these challenges may be
mitigated in part through targeted education and instruction.

Analysis is limited in that baseline metrics and variability are not well-defined, particularly in this setting. In the
context of a small patient population, exploratory analysis of collected data did suggest average preoperative daily
calories burned predicted length of hospital stay. However, variability among individual patients requires further
exploration. The relationship of preoperative activity levels and postoperative levels remains to be explored though
clearly correlations will exist. It is certainly feasible that objectively captured preoperative activity levels may
predict fitness for surgery and serve to stratify patients independently or in combination with currently used tools
with improved accuracy and negligible additional evaluative time on the part of clinicians.

In the postoperative setting, early ambulation and increased physical activity is often emphasized. ERAS protocols
in particular highlight the importance of early ambulation(14). However, these recommendations are not established
on objective data. The clinical effect of early ambulation remains to be established, particularly in relation to
baseline activity levels which often vary greatly among individual patients. We demonstrated non-home discharge
among patients with below the median inpatient daily steps counts and calories burned. However, ongoing analysis
will better define the relationship between activity levels and clinical outcomes, including incidence of
complications such as ileus, venous thromboembolism, and others. Though not demonstrated, the objective measure
of activity may further enable targeted patient interventions improving patient autonomy and participation in their
own care due to the potential for well-defined targetable goals.

The present study demonstrates the ability to utilize wearable fitness trackers among patients undergoing radical
cystectomy and obtain evaluable data. Due to its design, this study is limited in capacity to fully describe and
analyze the clinical applications of use of these devices. We utilized a single device, the Fitbit Alta HR. Alternative
platforms and wearable devices are available for similar activity tracking. The optimal device for clinical use is
unknown at this time. We selected Fitbit as it is currently among the leading wearable platforms. However, inherent
limitations to a wrist-worn wearable device must be considered as well potentially impacting the accuracy of
collected data.

CONCLUSION
Objective capture of relevant patient data is possible through the use of wearable fitness trackers among patients
undergoing radical cystectomy. Patient acceptance of and compliance with the use of wearable fitness trackers does
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not significantly limit applicability of wearable devices in the perioperative setting. Further study will define the
clinical implications of various evaluable metrics and guide patient care in the form of improved risk stratification
and objectively structured perioperative care.

8

REFERENCES
1. Lascano D, Pak JS, Kates M, Finkelstein JB, Silva M, Hagen E, et al. Validation of a frailty index in patients
undergoing curative surgery for urologic malignancy and comparison with other risk stratification tools. Urol
Oncol. 2015 Oct;33(10):426.e1-12.
2. Altobelli E, Buscarini M, Gill HS, Skinner EC. Readmission Rate and Causes at 90-Day after Radical
Cystectomy in Patients on Early Recovery after Surgery Protocol. Bladder Cancer Amst Neth. 2017 Jan
27;3(1):51–6.
3. Daneshmand S, Ahmadi H, Schuckman AK, Mitra AP, Cai J, Miranda G, et al. Enhanced recovery protocol
after radical cystectomy for bladder cancer. J Urol. 2014 Jul;192(1):50–5.
4. Chappidi MR, Kates M, Patel HD, Tosoian JJ, Kaye DR, Sopko NA, et al. Frailty as a marker of adverse
outcomes in patients with bladder cancer undergoing radical cystectomy. Urol Oncol. 2016 Jun;34(6):256.e1-6.
5. Froehner M, Brausi MA, Herr HW, Muto G, Studer UE. Complications following radical cystectomy for
bladder cancer in the elderly. Eur Urol. 2009 Sep;56(3):443–54.
6. Williams SB, Huo J, Chamie K, Hu JC, Giordano SH, Hoffman KE, et al. Underutilization of Radical
Cystectomy Among Patients Diagnosed with Clinical Stage T2 Muscle-invasive Bladder Cancer. Eur Urol
Focus. 2016 May 13;
7. Sathianathen NJ, Jarosek S, Lawrentschuk N, Bolton D, Konety BR. A Simplified Frailty Index to Predict
Outcomes After Radical Cystectomy. Eur Urol Focus. 2018 Jan 20;
8. Kaewkannate K, Kim S. A comparison of wearable fitness devices. BMC Public Health. 2016 May 24;16:433.
9. Evenson KR, Goto MM, Furberg RD. Systematic review of the validity and reliability of consumer-wearable
activity trackers. Int J Behav Nutr Phys Act. 2015;12:159.
10. Tison GH, Sanchez JM, Ballinger B, Singh A, Olgin JE, Pletcher MJ, et al. Passive Detection of Atrial
Fibrillation Using a Commercially Available Smartwatch. JAMA Cardiol. 2018 Mar 21;
11. Brown CJ, Roth DL, Allman RM. Validation of use of wireless monitors to measure levels of mobility during
hospitalization. J Rehabil Res Dev. 2008;45(4):551–8.
12. Rumer KK, Saraswathula A, Melcher ML. Prehabilitation in our most frail surgical patients: are wearable
fitness devices the next frontier? Curr Opin Organ Transplant. 2016 Apr;21(2):188–93.
13. Nehra AK, Gettman MT, Rivera ME, Agarwal DK, O’Neil DA, Jenkins SM, et al. A Survey of Perceptions and
Acceptance of Wearable Technology for Health Monitoring in a Urological Patient Population. Urol Pract.
4(6):508–14.
14. Cerantola Y, Valerio M, Persson B, Jichlinski P, Ljungqvist O, Hubner M, et al. Guidelines for perioperative
care after radical cystectomy for bladder cancer: Enhanced Recovery After Surgery (ERAS(®)) society
recommendations. Clin Nutr Edinb Scotl. 2013 Dec;32(6):879–87.

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TABLE 1: Cohort characteristics

Overall Cohort
Total patients enrolled 34*
Age (median) 74.0 years (64-80)
Male 22 (68.8%)
BMI (median) 25.0 (22.7-27.8)
Charlson Comorbidity Index (median) 2 (2-3)
Robotic RC 10 (29.4%)
Continent diversion 14 (41.2%)
Discharge to skilled nursing facility (SNF) 7 (21.9%)
*Out of 34 patients enrolled, 32 consented to use of additional personal health information for study

TABLE 2: WFT use and collected data

Median Days of Patient WFT Use
Preoperative 4.5 (0-6)
Inpatient 3 (2-5)
Postdischarge 7 (1-8)
Total 16 (11-22)
Daily Medians of Sleep and Activity Variables
Variable Preoperative Inpatient Postdischarge
Steps 4432 428 838
Calories Burned 2052 1841 1865
Sedentary Hours 15.35 13.91 17.61
Hours Asleep 5.43 6.23 5.25
Awakenings per hour asleep 2.00 0.85 0.97

Abstract (if available)

Abstract Background/Introduction: Wearable fitness trackers (WFTs) offer a novel method for objective evaluation and quantification of patient behavioral patterns. We sought to determine capacity for use of these devices to measure patient activity and sleep levels in the perioperative setting among patients undergoing radical cystectomy for bladder cancer. ❧ Methods: Under IRB approval, patients undergoing open or robotic RC were prospectively identified and consenting patients given a WFT for continuous use up to 2 weeks preoperatively, in the immediate postoperative period, and up to 2 weeks after discharge until first follow-up visit. Activity was automatically recorded and measured including total daily steps, calories burned, and sedentary hours. Sleep outcomes included total daily hours asleep and number of awakenings while sleeping. Delayed return of bowel function (dROBF) was defined as first bowel movement on postoperative day 3 or greater. ❧ Results: 34 patients were given a WFT for a median of 16 days total (IQR 11-22). Evaluable data was successfully retrieved from all patients. Exploratory analysis indicates relationship between daily inpatient steps below median 427.5 and non-home discharge disposition (p=0.033), as well as daily preoperative calories below median 2,052 and length of stay >6 days (p=0.029). ❧ Conclusion: Use of WFT to objectively measure patients’ activity, sleep, and other physiologic variables is feasible among patients undergoing radical cystectomy. Ongoing evaluation will provide further insights into patient functional status with implications for risk stratification, discharge planning, and perioperative management among patients undergoing radical cystectomy.

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Creator Zainfeld, Daniel Eric (author)

Core Title Assessing the utility of wearable fitness trackers for objective capture and quantification of activity levels among patients undergoing radical cystectomy

School Keck School of Medicine

Degree Master of Science

Degree Program Clinical, Biomedical and Translational Investigations

Publication Date 09/26/2018

Defense Date 09/05/2018

Publisher University of Southern California (original), University of Southern California. Libraries (digital)

Tag bladder cancer,Cystectomy,fitness trackers,OAI-PMH Harvest,wearables

Format application/pdf (imt)

Language English

Contributor Electronically uploaded by the author (provenance)

Advisor Daneshmand, Siamak (committee chair), Djaladat, Hooman (committee member), Schuckman, Anne (committee member)

Creator Email daniel.zainfeld@urologysa.com,danielzainfeld@gmail.com

Permanent Link (DOI) https://doi.org/10.25549/usctheses-c89-74049

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