The mean (diamond), quartiles, and minimum and maximum observations at each time point are shown in B.
On a scale of 0 to 100, 0 indicates no deviation from the expected postoperative course, and 100 indicates death. The median Comprehensive Complication Index is 15 (interquartile range, 0-22.6).
A, Higher scores indicate worse symptoms. B, The mean (diamond), quartiles, and minimum and maximum observations are shown, with higher scores indicating better health.
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Sun V, Dumitra S, Ruel N, et al. Wireless Monitoring Program of Patient-Centered Outcomes and Recovery Before and After Major Abdominal Cancer Surgery. JAMA Surg. 2017;152(9):852–859. doi:10.1001/jamasurg.2017.1519
Can wireless monitoring of patient-centered outcomes and recovery be carried out before and after major abdominal cancer surgery?
In this proof-of-concept pilot study that included 20 patients with 160 monitoring encounters, functional recovery monitoring using wristband pedometers was performed with up to 88% (17 of 20) adherence.
Wireless monitoring of functional recovery and patient-reported outcomes has the potential for early interventions by transforming data into actionable patient care.
A combined subjective and objective wireless monitoring program of patient-centered outcomes can be carried out in patients before and after major abdominal cancer surgery.
To conduct a proof-of-concept pilot study of a wireless, patient-centered outcomes monitoring program before and after major abdominal cancer surgery.
Design, Setting, and Participants
In this proof-of-concept pilot study, patients wore wristband pedometers and completed online patient-reported outcome surveys (symptoms and quality of life) 3 to 7 days before surgery, during hospitalization, and up to 2 weeks after discharge. Reminders via email were generated for all moderate to severe scores for symptoms and quality of life. Surgery-related data were collected via electronic medical records, and complications were calculated using the Clavien-Dindo classification. The study was carried out in the inpatient and outpatient surgical oncology unit of one National Cancer Institute–designated comprehensive cancer center. Eligible patients were scheduled to undergo curative resection for hepatobiliary and gastrointestinal cancers, were English speaking, and were 18 years or older. Twenty participants were enrolled over 4 months. The study dates were April 1, 2015, to July 31, 2016.
Main Outcomes and Measures
Outcomes included adherence to wearing the pedometer, adherence to completing the surveys (MD Anderson Symptom Inventory and EuroQol 5-dimensional descriptive system), and satisfaction with the monitoring program.
This study included a final sample of 20 patients (median age, 55.5 years [range, 22-74 years]; 15 [75%] female) with evaluable data. Pedometer adherence (88% [17 of 20] before surgery vs 83% [16 of 20] after discharge) was higher than survey adherence (65% to 75% [13 of 20 and 15 of 20] completed). The median number of daily steps at day 7 was 1689 (19% of daily steps at baseline), which correlated with the Comprehensive Complication Index, for which the median was 15 of 100 (r = −0.64, P < .05). Postdischarge overall symptom severity (2.3 of 10) and symptom interference with activities (3.5 of 10) were mild. Pain (4.4 of 10), fatigue (4.7 of 10), and appetite loss (4.0 of 10) were moderate after surgery. Quality-of-life scores were lowest at discharge (66.6 of 100) but improved at week 2 (73.9 of 100). While patient-reported outcomes returned to baseline at 2 weeks, the number of daily steps was only one-third of preoperative baseline.
Conclusions and Relevance
Wireless monitoring of combined subjective and objective patient-centered outcomes can be carried out in the surgical oncology setting. Preoperative and postoperative patient-centered outcomes have the potential of identifying high-risk populations who may need additional interventions to support postoperative functional and symptom recovery.
Major abdominal surgical procedures for gastrointestinal (GI) cancers are complex and at higher risk for postoperative complications, which can result in prolonged hospital stay, decreased functional status, and poor quality of life (QOL).1-5 Changes in the health care system have focused attention on integrating patient-centeredness into surgical oncology.6 The Institute of Medicine7 defines patient-centeredness as care that is respectful and responsive to patient preferences, needs, and values. A common approach to integrating this concept is to monitor patient-centered outcomes, which are defined as any health-related data created, recorded, gathered, or inferred by or from patients or caregivers to address a health concern.8
Functional status is an important aspect of surgical care and is often used to guide clinical decisions before and after surgery. Physical and functional limitations are common after major abdominal cancer surgery.9,10 Moreover, preliminary evidence suggests that functional status is a potential predictor of traditional surgical outcomes, such as postoperative complications, length of hospital stay, and readmissions.3,5,11-16 Patient-centered outcomes, including symptoms and QOL, are of major importance in abdominal surgery because of the high risk of postoperative complications and their potential effect.17,18 Indeed, QOL after abdominal procedures decreases considerably in the early postoperative phase, and full recovery is achieved up to 6 months after surgery.2,4,15,19
Technological advances with wearable devices and sensors enable the monitoring of patients’ longitudinal cancer experience.8 Pedometers that capture data on daily steps are an increasingly popular method of assessing functional status in research and clinical care because they are objective and inexpensive.20 Moreover, daily steps data can potentially serve as a surrogate of mobility and speed of recovery. A recent systematic review of 22 studies concluded that the validity and reliability of pedometers were generally high for measuring daily steps.21
To date, patient-centered outcomes are not routinely captured and monitored in the perioperative setting. The objectives of this study were to (1) determine whether a wireless, patient-centered outcomes monitoring program can be carried out for patients with cancer undergoing a major abdominal procedure; (2) describe the trajectory and trends of functional recovery (daily steps), symptoms, and QOL from before surgery to 2 weeks after discharge; and (3) evaluate whether an email alert system is feasible when deviations from predetermined outcome scores occur. We hypothesized that the monitoring program’s subjective and objective measures could shed light on patient-centered outcomes and functional status during postoperative recovery at home.
This investigation was a proof-of-concept pilot study. Patients eligible for participation in the study were scheduled to undergo curative resection for hepatobiliary and GI cancers (gastric, colorectal, liver, and pancreas), were English speaking, and were 18 years or older. All eligible patients who met the study inclusion criteria were identified and recruited from the surgical oncology ambulatory clinics of one National Cancer Institute–designated comprehensive cancer center between April 1, 2015, and July 31, 2016. Study procedures and the protocol were approved by the Institutional Review Board, and all participating patients provided written informed consent before enrollment. The study was registered at clinicaltrials.gov (NCT02511821).22
After informed consent, patients were given a commercially available wristband pedometer (Vivofit 2; Garmin Ltd) to monitor the number of daily steps as an objective patient-generated measure of functional recovery. Daily steps data were continuously collected 3 to 7 days before surgery, during hospitalization, and up to 2 weeks after discharge.
Patient-reported symptoms and QOL were assessed via an online system (DatStat; DatStat, Inc). The system sends personalized links to an online survey via a patient-provided email address. The survey contained 19 questions and included 2 validated measures. Symptom severity and symptom interference with activities were assessed using the MD Anderson Symptom Inventory (MDASI), a validated measure of 13 common cancer-related symptoms as rated on a 10-point scale.23 Quality of life and general health status were assessed using the EuroQol 5-dimensional descriptive system (EQ-5D-5L). This validated tool evaluates the following 5 QOL variables: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. One final item evaluates overall health state using a visual analog scale with the end points labeled “best to worst imaginable” health state (range, 0-100). The EQ-5D-5L has been widely used in clinical trials and in quality-adjusted survival analysis.24-27
Relevant clinical and surgical data were obtained via electronic medical record, including primary diagnosis, comorbidities, surgery date, procedure type, surgical technique (open, laparoscopic, or robotic assisted), American Society of Anesthesiologists’ classification, length of hospital stay, and readmissions. Each patient’s preoperative performance status was assessed using the Eastern Cooperative Oncology Group performance scale score ranging from 0 to 5, where 0 denotes an absence of symptoms and 5 denotes death. Postoperative complications were calculated using the Comprehensive Complication Index (CCI) based on the Clavien-Dindo classification.28,29 The CCI ranges from 0 to 100 and takes into account all 30-day complications and their treatment, where 0 indicates no deviation from the expected postoperative course and 100 indicates death.
Daily steps data were automatically and wirelessly synchronized via smartphones, tablets, and computer applications. With permission, patients’ daily steps data were shared with one of us (V.S.) via a secure group account created through an online system. Synchronized daily steps data were integrated into the study database via data capture procedures per the instructions of the manufacturer of the Vivofit 2. Patient-reported symptoms and QOL obtained via the online survey system were stored electronically in encrypted, password-protected secure computers that met all Health Insurance Portability and Accountability Act of 1996 requirements.
Online symptom recording and QOL surveys were completed once before surgery (baseline) and at hospital discharge. After discharge, patients were followed up for 2 weeks. During this time, they completed online symptom assessment 3 times per week (postdischarge days 1, 3, 5, 8, 10, and 12) and QOL assessment once per week (days 5 and 12). Patients completed a brief satisfaction survey that assessed monitoring acceptability. Every instance of patient completion of the online survey was considered a monitoring encounter, and the total number of monitoring encounters was recorded.
An email alert to one of us (V.S.) was automatically generated within 1 minute of survey completion for all moderate to severe scores for symptoms and QOL. This predetermined threshold prompted a telephone call from the research staff to the patient for further status assessment, as well as notification to the surgical team. Every instance of telephone assessment was considered a monitoring encounter, and the total number of monitoring encounters was recorded.
Data from the DatStat web-based system that we designed were audited for accuracy before analysis. Data were summarized using means for normally distributed continuous data, medians for nonnormally distributed continuous data, and proportions and percentages for categorical data. A correlation coefficient was calculated between the number of daily steps at day 7 and postoperative complications as calculated by the CCI. Established instruments were scored according to standard instructions, and appropriate descriptive statistics were computed. Outcomes were calculated for the percentage of patients who were able to complete (1) the MDASI and (2) the EQ-5D-5L after discharge, as well as the percentage of patients who were able to wear the Vivofit 2. Patient-reported satisfaction with the monitoring program was also assessed.
A total of 29 eligible patients were invited to participate in the study. Of those, 21 patients (72%) agreed to participate and provided written informed consent. The most common reasons patients gave for declining participation was being too busy or too overwhelmed. One consented patient had emergency surgery and discontinued study participation, yielding a final sample of 20 patients with evaluable data.
Study findings revealed that 88% (17 of 20) of patients wore the pedometer for at least 3 days before surgery (median, 6 days), 88% (17 of 20) wore the device for at least 3 days during hospitalization (median, 6 days), and 83% (16 of 20) wore the device for at least 1 week after discharge (median, 15 days). For electronic symptom assessment, 65% (13 of 20) completed the 8 evaluation time points. For QOL, 75% (15 of 20) completed the 4 evaluation time points. It took a mean of 7 minutes to complete the MDASI and a mean of 4 minutes to complete the EQ-5D-5L.
For satisfaction, patients reported that the pedometer (median, 5; range, 2-5) and the online survey system (median, 4; range, 2-5) were easy to use, where 0 is not satisfied and 5 is extremely satisfied. Three patients had difficulties with the pedometers: 2 of them lost the device, and the third had a malfunctioning battery. Most patients reported no difficulties with answering survey questions (95% [19 of 20]), and most found that the length of time was just right for completing the online surveys (95% [19 of 20]) and for using the device (70% [14 of 20]). Approximately 25% (5 of 20) of patients thought that the length of time for using the device was too short.
Table 1 lists the sociodemographic and clinical characteristics of the 20 patients enrolled over 4 months in this study. Their median age was 55.5 years, 75% were female, 65% were of white race, and 60% were married. Subdivision by resection site revealed 30% colorectal, 30% pancreas, 30% liver, and 10% gastric resections. The median number of self-reported comorbidities was 2 (range, 0-7), and most comorbid conditions were cardiovascular (40%). Forty percent of the procedures were minimally invasive. The median length of hospital stay was 6 days (range, 1-13 days). Two patients (10%) were discharged to a skilled nursing or rehabilitation facility, and 2 other patients were readmitted within 30 days for symptom management.
The median number of daily steps before surgery was 6562; this number decreased to 483 during hospitalization and increased to 2483 in the first 2 weeks after discharge (Figure 1A). Examination of functional status and daily steps from discharge to 2 weeks after discharge revealed that the mean and median daily steps were lowest during hospitalization (Figure 1). The number of daily steps steadily increased every 3 days after discharge until day 14, when it appeared to level off (Figure 1B). The median CCI was 15 of 100 (Table 1). The median number of steps at day 7 was 1689 (19% of daily steps at baseline) (Figure 1A), which correlated with the CCI (r = −0.64, P < .05). Patients with fewer daily steps had a higher CCI (Figure 2).
Figure 3 shows findings on the trajectory of symptom interference with activities and QOL collected before surgery and up to 2 weeks after discharge. Core symptom severity and overall symptom interference were worse at discharge and week 1 after discharge (days 1, 3, and 5), with gradual improvement at week 2. Similarly, overall QOL and general health status scores were lowest at discharge and week 1 after discharge but improved at week 2.
Table 2 summarizes the trajectory of the mean scores for individual symptom and QOL dimension items. Patients reported mild to moderate severity for fatigue and pain at 1 week after discharge, with gradual improvement to mild severity at week 2. For QOL dimensions, patients reported moderate problems with usual activities at discharge.
Of the 160 monitoring encounters throughout the study (defined as the number of times patients completed the online surveys), 54 (34%) generated an email notification to the research staff. Of those, 39 telephonic monitoring encounters (72%) were for symptoms. The most commonly reported symptom was pain, and patients often reported not taking the prescribed medication. Most of the email alerts were generated during the first week and then decreased during the second week of monitoring.
This study found that a wireless, patient-centered outcomes monitoring program that incorporated subjective and objective measures of recovery can be carried out in patients with cancer undergoing major abdominal surgery. Routine monitoring of patient-centered outcomes has predominantly been tested in chemotherapy settings,30,31 with positive effects on facilitating patient-clinician communication,32-35 detecting unrecognized problems,31,35-38 guiding clinical care,37,39-41 and improving health outcomes.41-45 In transplant patients, changes in symptom intensity and global physical health were significantly associated with changes in the mean daily steps, as measured by wearable pedometers.20 Although these data are promising, the present study is one of the first to shed light on integrating wireless monitoring of patient-centered outcomes and functional recovery in a surgical oncology population.
Adherence to wearing the wristband pedometer was acceptable, and patients were satisfied with the wireless monitoring program. The response rates to the online survey of 65% to 75% are similar to other rates reported in surgical populations. A pilot study46 in colorectal cancer surgery using tablets to assess symptoms and QOL reported a slightly lower adherence rate (63%). Measurement of step numbers using commercially available pedometers serves as an objective metric of patients’ functional status and recovery. These measurements allow real-time efficient, unobtrusive monitoring regardless of patients’ cognition, literacy, language, or health status. Moreover, they complement and augment subjective reports of symptoms and QOL and are typically low cost and comfortable to wear in the long term.20 This study is one of the first to combine real-time monitoring of both objective functional status and subjective patient-reported symptoms and QOL.
Our analysis of mobility revealed that, as expected, an abrupt decrease in the number of daily steps occurred between preoperative baseline and 1 week after discharge, with corresponding worsening of symptom and QOL scores. We observed a potential correlation between fewer daily steps and a higher CCI, indicating that patients with higher complication rates are less mobile, a trend that has been previously reported.43 Psychological and physical concerns may indeed limit a patient’s willingness to walk. By monitoring these symptoms closely, the surgical team and hospital staff have the opportunity to address them as early as possible and thus influence recovery time and overall QOL. The feedback system revealed that 34% of monitoring encounters generated email alerts and created an opportunity for assessment and communication with patients because most of the email alerts were related to symptoms.
A notable finding from the present study is the discordance between subjective and objective functional recovery. At 2 weeks after surgery, patients reported a return to baseline in terms of symptoms and QOL; however, their mobility and number of daily steps (one-third of preoperative baseline) lagged behind. While patients may not report problems during their postoperative visits, they might benefit from encouragement or more aggressive measures, such as a consultation with a physiotherapist.
Study findings suggest that our wireless program incorporating both subjective and objective parameters of recovery has the potential to provide opportunities for tailored postoperative care. For example, patients discharged home before day 7 with a poor functional status could be seen in clinic earlier or can undergo a physician telephonic evaluation in an attempt to detect complications earlier and thus prevent readmissions.
There are several limitations to this study that warrant further discussion. First, an important limitation of this study is the small sample size. This sample was derived to be realistic and practical for the short study time frame, and our intent was to determine as a proof of concept whether the wireless monitoring program described herein can be administered prospectively and continuously in the perioperative setting. Second, our study population included a variety of operation types with different risk profiles, which can affect study findings. Although a more homogeneous population (ie, focused on patients with liver or gastric surgery only) could make it easier for certain comparisons, the present population of diverse abdominal surgical procedures for various GI cancers reflects the ultimate population in which our program could be implemented despite their various complication profiles and postoperative course. A third limitation is the nature of the patient population, which was of high socioeconomic status, well educated, and technologically savvy. The adherence and feasibility of this program might be different in a more diverse population. To address these limitations, we are planning on conducting a broader study of 283 patients comprising geographically and socioeconomically diverse English-speaking and Spanish-speaking populations. The large trial will also provide the opportunity to examine potential differences in functional recovery based on type of operation and risk profiles.
Important strengths of this study include the assessment of preoperative data that served as a baseline and the use of both subjective and objective measures of patient-centered functional recovery. Another strength is the portability and adaptability of the developed monitoring program to other clinical settings. Moreover, given the wireless nature of the technology, monitoring could be performed in a centralized fashion. Further studies among larger populations need to be performed to confirm associations between outcomes, as well as to devise real-time interventions based on the data collected. Moreover, a longer period of monitoring up to 60 days might be beneficial to truly capture patients’ return to baseline mobility and QOL.
Wireless monitoring of patient-centered outcomes can be carried out both before and after major abdominal cancer surgery. A planned large trial will determine whether these outcomes can augment existing surgical prediction tools and provide a more patient-centered approach to measuring quality in surgical oncology. Wireless technology has the potential to detect real-time changes in symptom severity, mobility, and QOL and could provide opportunities for early intervention when deviations from the expected postoperative course occur.
Accepted for Publication: March 10, 2017.
Corresponding Author: Virginia Sun, PhD, RN, Division of Nursing Research and Education, Department of Population Sciences, City of Hope, 1500 E Duarte Rd, Duarte, CA 91010 (firstname.lastname@example.org).
Published Online: June 7, 2017. doi:10.1001/jamasurg.2017.1519
Author Contributions: Dr Sun had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs Sun and Dumitra contributed equally to this work.
Study concept and design: Sun, Dumitra, Lee, Fong.
Acquisition, analysis, or interpretation of data: Sun, Dumitra, Ruel, L. Melstrom, K. Melstrom, Woo, Sentovich, Singh, Fong.
Drafting of the manuscript: Sun, Dumitra, Fong.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Sun, Dumitra, Ruel.
Obtained funding: Sun, Fong.
Administrative, technical, or material support: Sun, K. Melstrom, Woo, Singh, Fong.
Study supervision: Sun, Lee, K. Melstrom, Sentovich, Singh, Fong.
Conflict of Interest Disclosures: None reported.
Funding/Support: The research reported in this article was supported by the National Cancer Institute of the National Institutes of Health under award P30CA33572. It included work performed in the Survey Research Core and Biostatistics Core supported under the award number.
Role of the Funder/Sponsor: The funding organization had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health.
Meeting Presentation: This study was presented at the Owen H. Wangensteen Scientific Forum of the American College of Surgeons Clinical Congress 2016; October 17, 2016; Washington, DC.