Optimization of alert notifications in electronic patient-reported outcome (ePRO) remote symptom monitoring systems (AFT-39).

PURPOSE: Clinical benefits result from electronic patient-reported outcome (ePRO) systems that enable remote symptom monitoring. Although clinically useful, real-time alert notifications for severe or worsening symptoms can overburden nurses. Thus, we aimed to algorithmically identify likely non-urgent alerts that could be suppressed. METHODS: We evaluated alerts from the PRO-TECT trial (Alliance AFT-39) in which oncology practices implemented remote symptom monitoring. Patients completed weekly at-home ePRO symptom surveys, and nurses received real-time alert notifications for severe or worsening symptoms. During parts of the trial, patients and nurses each indicated whether alerts were urgent or could wait until the next visit. We developed an algorithm for suppressing alerts based on patient assessment of urgency and model-based predictions of nurse assessment of urgency. RESULTS: 593 patients participated (median age = 64 years, 61% female, 80% white, 10% reported never using computers/tablets/smartphones). Patients completed 91% of expected weekly surveys. 34% of surveys generated an alert, and 59% of alerts prompted immediate nurse actions. Patients considered 10% of alerts urgent. Of the remaining cases, nurses considered alerts urgent more often when patients reported any worsening symptom compared to the prior week (33% of alerts with versus 26% without any worsening symptom, p = 0.009). The algorithm identified 38% of alerts as likely non-urgent that could be suppressed with acceptable discrimination (sensitivity = 80%, 95% CI [76%, 84%]; specificity = 52%, 95% CI [49%, 55%]). CONCLUSION: An algorithm can identify remote symptom monitoring alerts likely to be considered non-urgent by nurses, and may assist in fostering nurse acceptance and implementation feasibility of ePRO systems.

Financial Toxicity Monitoring in a Randomized Controlled Trial of Patient-Reported Outcomes During Cancer Treatment (Alliance AFT-39).

PURPOSE: Financial toxicity (FT) affects 20% of cancer survivors and is associated with poor clinical outcomes. No large-scale programs have been implemented to mitigate FT. We evaluated the effect of monthly FT screening as part of a larger patient-reported outcomes (PROs) digital monitoring intervention. METHODS: PRO-TECT (AFT-39) is a cluster-randomized trial of patients undergoing systemic therapy for metastatic cancer. Practices were randomly assigned 1:1 to digital symptom monitoring (PRO practices) or usual care (control practices). Digital monitoring consisted of between-visit online or automated telephone patient surveys about symptoms, functioning, and FT (single-item screening question from Functional Assessment of Chronic Illness Therapy-COmprehensive Score for financial Toxicity) for up to 1 year, with automated alerts sent to practice nurses for concerning survey scores. Clinical team actions in response to alerts were not mandated. The primary outcome of this planned secondary analysis was development or worsening of financial difficulties, assessed via the European Organisation for Research and Treatment of Cancer QLQ-C30 financial difficulties measure, at any time compared with baseline. A randomly selected subset of patients and nurses were interviewed about their experiences with the intervention. RESULTS: One thousand one hundred ninety-one patients were enrolled (593 PRO; 598 control) at 52 US community oncology practices. Overall, 30.2% of patients treated at practices that received the FT screening intervention developed, or experienced worsening of, financial difficulties, compared with 39.0% treated at control practices (P = .004). Patients and nurses interviewed stated that FT screening identified patients for financial counseling who otherwise would be reluctant to seek, or unaware of the availability of, assistance. CONCLUSION: In this report of a secondary outcome from a randomized clinical trial, FT screening as part of routine digital patient monitoring with PROs reduced the development, or worsening, of financial difficulties among patients undergoing systemic cancer therapy.

Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer: A Randomized Clinical Trial.

Importance: Electronic systems that facilitate patient-reported outcome (PRO) surveys for patients with cancer may detect symptoms early and prompt clinicians to intervene. Objective: To evaluate whether electronic symptom monitoring during cancer treatment confers benefits on quality-of-life outcomes. Design, Setting, and Participants: Report of secondary outcomes from the PRO-TECT (Alliance AFT-39) cluster randomized trial in 52 US community oncology practices randomized to electronic symptom monitoring with PRO surveys or usual care. Between October 2017 and March 2020, 1191 adults being treated for metastatic cancer were enrolled, with last follow-up on May 17, 2021. Interventions: In the PRO group, participants (n = 593) were asked to complete weekly surveys via an internet-based or automated telephone system for up to 1 year. Severe or worsening symptoms triggered care team alerts. The control group (n = 598) received usual care. Main Outcomes and Measures: The 3 prespecified secondary outcomes were physical function, symptom control, and health-related quality of life (HRQOL) at 3 months, measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30; range, 0-100 points; minimum clinically important difference [MCID], 2-7 for physical function; no MCID defined for symptom control or HRQOL). Results on the primary outcome, overall survival, are not yet available. Results: Among 52 practices, 1191 patients were included (mean age, 62.2 years; 694 [58.3%] women); 1066 (89.5%) completed 3-month follow-up. Compared with usual care, mean changes on the QLQ-C30 from baseline to 3 months were significantly improved in the PRO group for physical function (PRO, from 74.27 to 75.81 points; control, from 73.54 to 72.61 points; mean difference, 2.47 [95% CI, 0.41-4.53]; P = .02), symptom control (PRO, from 77.67 to 80.03 points; control, from 76.75 to 76.55 points; mean difference, 2.56 [95% CI, 0.95-4.17]; P = .002), and HRQOL (PRO, from 78.11 to 80.03 points; control, from 77.00 to 76.50 points; mean difference, 2.43 [95% CI, 0.90-3.96]; P = .002). Patients in the PRO group had significantly greater odds of experiencing clinically meaningful benefits vs usual care for physical function (7.7% more with improvements of ≥5 points and 6.1% fewer with worsening of ≥5 points; odds ratio [OR], 1.35 [95% CI, 1.08-1.70]; P = .009), symptom control (8.6% and 7.5%, respectively; OR, 1.50 [95% CI, 1.15-1.95]; P = .003), and HRQOL (8.5% and 4.9%, respectively; OR, 1.41 [95% CI, 1.10-1.81]; P = .006). Conclusions and Relevance: In this report of secondary outcomes from a randomized clinical trial of adults receiving cancer treatment, use of weekly electronic PRO surveys to monitor symptoms, compared with usual care, resulted in statistically significant improvements in physical function, symptom control, and HRQOL at 3 months, with mean improvements of approximately 2.5 points on a 0- to 100-point scale. These findings should be interpreted provisionally pending results of the primary outcome of overall survival. Trial Registration: ClinicalTrials.gov Identifier: NCT03249090.

Stakeholder Perceptions of Key Aspects of High-Quality Cancer Care to Assess with Patient Reported Outcome Measures: A Systematic Review.

Performance measurement is the process of collecting, analyzing, and reporting standardized measures of clinical performance that can be compared across practices to evaluate how well care was provided. We conducted a systematic review to identify stakeholder perceptions of key symptoms and health domains to test as patient-reported performance measures in oncology. Stakeholders included cancer patients, caregivers, clinicians, and healthcare administrators. Standard review methodology was used, consistent with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). MEDLINE/PubMed, EMBASE, and the Cochrane Library were searched to identify relevant studies through August 2020. Four coders independently reviewed entries and conflicts were resolved by a fifth coder. Efficacy and effectiveness studies, and studies focused exclusively on patient experiences of care (e.g., communication skills of providers) were excluded. Searches generated 1813 articles and 1779 were coded as not relevant, leaving 34 international articles for extraction. Patients, caregivers, clinicians, and healthcare administrators prioritize psychosocial care (e.g., distress) and symptom management for patient-reported performance measures. Patients and caregivers also perceive that maintaining physical function and daily activities are critical. Clinicians and administrators perceive control of specific symptoms to be critical (gastrointestinal symptoms, pain, poor sleep). Results were used to inform testing at six US cancer centers.

Clinical Utility and User Perceptions of a Digital System for Electronic Patient-Reported Symptom Monitoring During Routine Cancer Care: Findings From the PRO-TECT Trial.

PURPOSE: There is increasing interest in implementing digital systems for remote monitoring of patients' symptoms during routine oncology practice. Information is limited about the clinical utility and user perceptions of these systems. METHODS: PRO-TECT is a multicenter trial evaluating implementation of electronic patient-reported outcomes (ePROs) among adults with advanced and metastatic cancers receiving treatment at US community oncology practices (ClinicalTrials.gov identifier: NCT03249090). Questions derived from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) are administered weekly by web or automated telephone system, with alerts to nurses for severe or worsening symptoms. To elicit user feedback, surveys were administered to participating patients and clinicians. RESULTS: Among 496 patients across 26 practices, the majority found the system and questions easy to understand (95%), easy to use (93%), and relevant to their care (91%). Most patients reported that PRO information was used by their clinicians for care (70%), improved discussions with clinicians (73%), made them feel more in control of their own care (77%), and would recommend the system to other patients (89%). Scores for most patient feedback questions were significantly positively correlated with weekly PRO completion rates in both univariate and multivariable analyses. Among 57 nurses, most reported that PRO information was helpful for clinical documentation (79%), increased efficiency of patient discussions (84%), and was useful for patient care (75%). Among 39 oncologists, most found PRO information useful (91%), with 65% using PROs to guide patient discussions sometimes or often and 65% using PROs to make treatment decisions sometimes or often. CONCLUSION: These findings support the clinical utility and value of implementing digital systems for monitoring PROs, including the PRO-CTCAE, in routine cancer care.

Using Stakeholder Engagement to Overcome Barriers to Implementing Patient-reported Outcomes (PROs) in Cancer Care Delivery: Approaches From 3 Prospective Studies.

INTRODUCTION: Patient-reported outcome (PRO) measures used during cancer care delivery improve communication about symptoms between patients and clinicians and reduce service utilization for uncontrolled symptoms. However, uptake of PROs in routine cancer care has been slow. In this paper, we describe stakeholder engagement activities used to overcome barriers to implementing PROs. Implementation occurred in 2 study settings: PROs completed in the waiting room and reviewed during clinical visits to guide symptom management for multiple myeloma (visit-based PROs); and weekly PROs completed by cancer patients between chemotherapy visits to monitor symptoms at home (remote PROs). METHODS: PRO implementation steps across studies included: (1) clinician and patient input on key symptoms, PRO measures, and identifying which PRO responses are clinically concerning to better target nursing actions; (2) developing PRO-based clinical decision support (CDS) for responding to concerning PROs; (3) training clinicians and clinical research assistants to interpret PROs and use software; and (4) describing implementation impact (frequency of concerning PRO responses and nursing actions). DISCUSSION: Clinician and patient input was critical for identifying key symptoms, PRO measures, and clinically concerning response options. For the visit-based PRO observational study, all symptom scores appeared on a clinician dashboard, and those rated ≥1 by patients (on a 0-4 or 0-10 scale) had PRO-based CDS available for access. For the 2 remote PROs trials, stakeholders recommended that the 2 "worst" response options (eg, PRO responses of "often"/"always" or "severe"/"very severe") would trigger an automated email alert to a nurse along with PRO-based CDS. In each study, PRO-based CDS was tailored based on clinician input. Across studies, the most common nursing response to concerning PROs was counseling patients on (or providing care plans for) self-management of symptoms. In the trials, the percentage of weekly remote PROs generating an alert to a nurse ranged from 13% at an academic center to 36% in community oncology practices. KEY POINTS: Across 3 prospective studies, PROs implemented into cancer care enabled tailored care based on issues identified on PROs. Stakeholder engagement was critical for successful implementation. This paper assists in addressing important PRO implementation challenges by describing a stakeholder-driven approach.

Novel approaches to obesity prevention: effects of game enjoyment and game type on energy expenditure in active video games.

BACKGROUND: Some active video games have been found to promote physical activity adherence because of enjoyment. However, many active games are exercise themed, which may interfere with the distracting properties that make game-based exercise more enjoyable than traditional exercise. This study compared exercise-themed and game-themed active games to investigate differences in energy expenditure and enjoyment. METHOD: Young adults (N = 100, 50 female, 55 overweight, aged 18-35 years) played two of four Wii Fit games (one aerobic game and one balance game per person) for 10 min each. Of the two aerobic games, one was exercise themed (jogging) and the other was game themed (hula hooping). Both balance games were game themed. Energy expenditure and enjoyment were measured. RESULTS: After adjustment for gender and weight, aerobic games produced 2.70 kcal/kg(-1)/h(-1) (95% confidence interval 2.41, 3.00) greater energy expenditure than balance games (p < .001), but balance games were more enjoyable (p < .001). In aerobic games, jogging produced greater energy expenditure than hula hooping in normal-weight and male participants (p < .001); in overweight and female participants, no differences were found (p > .17). Hula hooping was enjoyed more than jogging (p = .008). Enjoyment predicted energy expenditure in aerobic games (B = 0.767, p = .010). CONCLUSIONS: Aerobic games produced greater energy expenditure but lower enjoyment than balance games, and a game-themed aerobic game was found more enjoyable than an exercise-themed aerobic game. Integrating more strenuous activity into entertaining games instead of games that simply simulate exercise may be a fruitful avenue for active game development.