Electronic Patient-Reported Outcomes Tool Research Articles

Real-world use and clinical impact of an electronic patient-reported outcome tool in patients with solid tumors treated with immuno-oncology therapy

BackgroundUtilization of electronic patient-reported outcome (ePRO) tools to monitor symptoms in patients undergoing cancer treatment has shown clinical benefits. Tennessee Oncology (TO) implemented an ePRO platform in 2019, allowing patients to report their health status online. We conducted a real-world, multicenter, observational, non-interventional cohort study to evaluate utilization of this platform in adults with solid tumors who initiated immuno-oncology (IO) therapy as monotherapy or in combination at TO clinics.MethodsPatients initiating IO therapy prior to platform implementation were included in a historical control (HC) cohort; those initiating treatment after implementation were included in the ePRO cohort, which was further divided into ePRO users (platform enrollment ≤ 45 days from IO initiation) and non-users. Data were extracted from electronic medical records; patients were followed for up to 6 months (no minimum follow up). Outcomes included patient characteristics, treatment patterns, duration of therapy (DoT), and overall survival (OS).ResultsData were collected for 538 patients in the HC and 1014 in the ePRO cohort; 319 in the ePRO cohort were ePRO users (uptake rate 31%). Baseline age was higher, more patients had stage IV disease at diagnosis, and more received monotherapy (82 vs 52%, respectively) in the HC vs the ePRO cohort. Median follow-up was 181.0 days (range 0.0–182.6) in the HC and 175.0 (0.0–184.0) in the ePRO cohort. Median DoT of index IO regimen was 5.1 months (95% confidence interval [CI], 4.4–NE) in the HC cohort vs not estimable (NE) in the ePRO cohort. Multivariable regression adjusting for baseline differences confirmed lower risk of treatment discontinuation in the ePRO vs HC cohort: hazard ratio (HR) 0.83 (95% CI, 0.71–0.97); p < 0.05. The estimated 6-month OS rate was 65.5% in the HC vs 72.4% in the ePRO cohort (p < 0 .01). Within the ePRO cohort, DoT of index IO regimen and OS did not differ between users and non-users. In ePRO users, patient platform use was durable over 6 months.ConclusionImprovements in DoT and OS were seen after ePRO platform implementation. Conclusions are limited by challenges in separating the impact of platform implementation from other changes affecting outcomes.

Usability testing of PatientToc™, an electronic patient reported outcomes tool: lessons learned

Usability testing of PatientToc™, an electronic patient reported outcomes tool: lessons learned

An ehealth intervention during radical radiotherapy: Patient-Reported Outcome Side effects (PROSE) study—An emerging approach from sub-Saharan Africa.

6628 Background: PROSE is an electronic patient-reported outcome tool for real-time, remote monitoring of treatment related side-effects. It enables a two way communication between the patient and clinicians. Remote monitoring of treatment related toxicities can eliminate underreporting of side effects (SE), facilitate timely symptom assessment, and improve management of SE. These will thereby reduce morbidity and hospitalization and improve treatment outcomes and quality of life of affected patients. The overarching goal of the study is to enhance the efficiency of the conventional weekly SE clinic using an emerging technology and thereby create evidence for a personalized digital health interventions for cancer patients in Africa. Methods: A prospective study among adult cancer patients receiving radical radiotherapy for head and neck, pelvic, and breast cancers at NSIA-LUTH Cancer Centre in Nigeria between March and October 2022. Eligible (≥18 years, KPS≥75%) and consenting participants were trained on to report their SE daily and receive remote clinical advice on prosecare.com . The PROSE tool was built as an adapted version of the Patient Reported Outcome version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The study participants were monitored throughout their radiotherapy sessions and two weeks thereafter. The cancer care team can review the Patients Reported Outcome (PRO) data through a dedicated log-in portal during the SE clinic. Participants scored their SE daily and EORTC QLQ-30 quality of life surveys were administered thrice during the study and 2 weeks thereafter. SE reports were chosen according to the site of disease; 12 items for head and neck tumors, 9 items for breast tumors, 14 items for female pelvic and 18 items for male pelvic tumors. Patient’s PROSE tool application utilization was defined as &gt;50% daily reporting during study period. Results: A total of 137 participants were screened, of which 120 met the eligibility criteria. Of the 120 patients eligible, 23 had technical issues with the use of the PROSE tool application and 1 died during the study; thus, 96 participants data were analyzed. More than 40,000 SE reports were generated during the study. SE with highest symptom burden include urinary frequency in male pelvic cancers (n=17), radiation dermatitis in breast cancer (n=40), diarrhea in female pelvic cancer (n=19) and xerostomia in head/neck cancers (n=20). The app utilization rate was 58%. Conclusions: There was a moderate utilization (58%) of the PROSE tool application. The PROSE pilot study demonstrated the potential utility of the PROSE application as a promising tool and data resource that offers a great opportunity to improve cancer care and the development of predictive clinical algorithms by engaging patients in their own care and increased SE reporting of acute radiation toxicities.

Feasibility of an Electronic Patient-Reported Outcome Tool for Screening Distress and Supportive Care Needs of Adolescents and Young Adults with Cancer.

Purpose: Although adolescent and young adult (AYA) cancer patients are digital natives and have high digital communication needs, previous studies of screening tools for AYAs have primarily used paper when measuring patient-reported outcomes (PROs). There are no reports on using an electronic PRO (ePRO) screening tool with AYAs. This study evaluated the feasibility of such a tool in clinical settings, and assessed the prevalence of AYAs' distress and supportive care needs. Methods: An ePRO tool based on the Distress Thermometer and Problem List (DTPL)-Japanese (DTPL-J) version for AYAs was implemented in a clinical setting for 3 months. To determine the prevalence of distress and need for supportive care, descriptive statistics were calculated for participant characteristics, selected items, and Distress Thermometer (DT) scores. Response rates, referral rates to an attending physician and other experts, and time required to complete PRO tools were assessed to evaluate feasibility. Results: From February to April 2022, 244 (93.8%) of 260 AYAs completed the ePRO tool based on the DTPL-J for AYAs. Based on a DT cutoff of ≥5, 65 of 244 patients (26.6%) had high distress. Worry (n = 81, 33.2%) was the most frequently selected item. Primary nurses referred 85 (32.7%) patients to an attending physician or other experts. The referral rate resulting from ePRO screening was significantly higher than that after PRO screening (χ2(1) = 17.99, p < 0.001). The average response time did not differ significantly between ePRO and PRO screening (p = 0.252). Conclusion: This study suggests the feasibility of an ePRO tool based on the DTPL-J for AYAs.

Patient-Reported Outcomes Collection at an Urban HIV Clinic Associated With a Historically Black Medical College in the Southern United States: Qualitative Interview Study Among Patients With HIV.

Black Americans, particularly in the southern United States, are disproportionately affected by the US HIV epidemic. Patient-reported outcome (PRO) data collection can improve patient outcomes and provide oft-overlooked data on mental health, substance use, and patient adherence to antiretroviral therapy. We piloted the use of an electronic tablet to collect PRO data on social and behavioral determinants of health among people with HIV at the Meharry Community Wellness Center, an HIV clinic affiliated with a Historically Black Medical College in Nashville, Tennessee. Our primary objective was to better understand patients' experiences and comfort with using an electronic PRO tool through patient interviews. We enrolled 100 people with HIV in care at the Meharry Community Wellness Center consecutively to completely validate PRO tools using the Research Electronic Data Capture platform on a hand-held tablet. Using a purposive sampling strategy, we enrolled 20 of the 100 participants in an in-depth interview (IDI). Interview guide development was grounded in the cognitive-behavioral model, in which thoughts, feelings, and behaviors are interrelated. IDIs were audio recorded, transcribed, deidentified, and formatted for coding. A hierarchical coding system was developed and refined using an inductive-deductive approach. Among the 100 people with HIV enrolled, the median age was 50 (IQR 42-54) years; 89% (n=89) were Black, 60% (n=60) were male, and 82% (n=82) were living below 100% of the federal poverty level in 2016. Five major interview themes emerged: overall experience, question content, sensitive topics, clinic visit impact, and future recommendations. IDI participants felt that the tablet was easy to use and that the question content was meaningful. Question content related to trauma, sexual and drug use behaviors, mental health, stigma, and discrimination elicited uncomfortable or distressing feelings in some participants. Patients expressed a strong desire to be truthful, and most would complete these surveys without compensation at future visits if offered. The use of an electronic tablet to complete PRO data collection was well received by this cohort of vulnerable persons in HIV care in the southern United States. Despite some discomfort related to question content, our cohort overwhelmingly believed this was a meaningful part of their medical experience and expressed a high desire for truthfulness. Future research will focus on scaling up the implementation and evaluation of PRO data collection in a contextually appropriate manner while obtaining input from providers and staff to ensure that the collected data are both applicable and actionable.

An Electronic Patient-Reported Outcomes Tool for Older Adults With Complex Chronic Conditions: Cost-Utility Analysis.

BackgroundeHealth technologies for self-management can improve quality of life, but little is known about whether the benefits gained outweigh their costs. The electronic patient-reported outcome (ePRO) mobile app and portal system supports patients with multiple chronic conditions to collaborate with primary health care providers to set and monitor health-related goals.ObjectiveThis study aims to estimate the cost of ePRO and the cost utility of the ePRO intervention compared with usual care provided to patients with multiple chronic conditions and complex needs living in the community, from the perspective of the publicly funded health care payer in Ontario, Canada.MethodsWe developed a decision tree model to estimate the incremental cost per quality-adjusted life year (QALY) gained for the ePRO tool versus usual care over a time horizon of 15 months. Resource utilization and effectiveness of the ePRO tool were drawn from a randomized clinical trial with 6 family health teams involving 45 participants. Unit costs associated with health care utilization (adjusted to 2020 Canadian dollars) were drawn from literature and publicly available sources. A series of sensitivity analyses were conducted to assess the robustness of the findings.ResultsThe total cost of the ePRO tool was CAD $79,467 (~US $ 63,581; CAD $1733 [~US $1386] per person). Compared with standard care, the ePRO intervention was associated with higher costs (CAD $1710 [~US $1368]) and fewer QALYs (–0.03). The findings were consistent with the clinical evidence, suggesting no statistical difference in health-related quality of life between ePRO and usual care groups. However, the tool would be considered a cost-effective option if it could improve by at least 0.03 QALYs. The probability that the ePRO is cost-effective was 17.3% at a willingness-to-pay (WTP) threshold of CAD $50,000 (~US $40,000)/QALY.ConclusionsThe ePRO tool is not a cost-effective technology at the commonly used WTP value of CAD $50,000 (~US $40,000)/QALY, but long-term and the societal impacts of ePRO were not included in this analysis. Further research is needed to better understand its impact on long-term outcomes and in real-world settings. The present findings add to the growing evidence about eHealth interventions’ capacity to respond to complex aging populations within finite-resourced health systems.Trial RegistrationClinicalTrials.gov NCT02917954; https://clinicaltrials.gov/ct2/show/NCT02917954

Utilization of an Automated SMS-based Electronic Patient Reported Outcome Tool in Spinal Surgery Patients

Utilization of an Automated SMS-based Electronic Patient Reported Outcome Tool in Spinal Surgery Patients

Assessing the Implementation and Effectiveness of the Electronic Patient-Reported Outcome Tool for Older Adults With Complex Care Needs: Mixed Methods Study.

BackgroundGoal-oriented care is being adopted to deliver person-centered primary care to older adults with multimorbidity and complex care needs. Although this model holds promise, its implementation remains a challenge. Digital health solutions may enable processes to improve adoption; however, they require evaluation to determine feasibility and impact.ObjectiveThis study aims to evaluate the implementation and effectiveness of the electronic Patient-Reported Outcome (ePRO) mobile app and portal system, designed to enable goal-oriented care delivery in interprofessional primary care practices. The research questions driving this study are as follows: Does ePRO improve quality of life and self-management in older adults with complex needs? What mechanisms are likely driving observed outcomes?MethodsA multimethod, pragmatic randomized controlled trial using a stepped-wedge design and ethnographic case studies was conducted over a 15-month period in 6 comprehensive primary care practices across Ontario with a target enrollment of 176 patients. The 6 practices were randomized into either early (3-month control period; 12-month intervention) or late (6-month control period; 9-month intervention) groups. The primary outcome measure of interest was the Assessment of Quality of Life-4D (AQoL-4D). Data were collected at baseline and at 3 monthly intervals for the duration of the trial. Ethnographic data included observations and interviews with patients and providers at the midpoint and end of the intervention. Outcome data were analyzed using linear models conducted at the individual level, accounting for cluster effects at the practice level, and ethnographic data were analyzed using qualitative description and framework analysis methods.ResultsRecruitment challenges resulted in fewer sites and participants than expected; of the 176 target, only 142 (80.6%) patients were identified as eligible to participate because of lower-than-expected provider participation and fewer-than-expected patients willing to participate or perceived as ready to engage in goal-setting. Of the 142 patients approached, 45 (32%) participated. Patients set a variety of goals related to self-management, mental health, social health, and overall well-being. Owing to underpowering, the impact of ePRO on quality of life could not be definitively assessed; however, the intervention group, ePRO plus usual care (mean 15.28, SD 18.60) demonstrated a nonsignificant decrease in quality of life (t24=−1.20; P=.24) when compared with usual care only (mean 21.76, SD 2.17). The ethnographic data reveal a complex implementation process in which the meaningfulness (or coherence) of the technology to individuals’ lives and work acted as a key driver of adoption and tool appraisal.ConclusionsThis trial experienced many unexpected and significant implementation challenges related to recruitment and engagement. Future studies could be improved through better alignment of the research methods and intervention to the complex and diverse clinical settings, dynamic goal-oriented care process, and readiness of provider and patient participants.Trial RegistrationClinicalTrials.gov NCT02917954; https://clinicaltrials.gov/ct2/show/NCT02917954

Exploring the perspectives of primary care providers on use of the electronic Patient Reported Outcomes tool to support goal-oriented care: a qualitative study

BackgroundDigital health technologies can support primary care delivery, but clinical uptake in primary care is limited. This study explores enablers and barriers experienced by primary care providers when adopting new digital health technologies, using the example of the electronic Patient Reported Outcome (ePRO) tool; a mobile application and web portal designed to support goal-oriented care. To better understand implementation drivers and barriers primary care providers’ usage behaviours are compared to their perspectives on ePRO utility and fit to support care for patients with complex care needs.MethodsThis qualitative sub-analysis was part of a larger trial evaluating the use of the ePRO tool in primary care. Qualitative interviews were conducted with providers at the midpoint (i.e. 4.5–6 months after ePRO implementation) and end-point (i.e. 9–12 months after ePRO implementation) of the trial. Interviews explored providers’ experiences and perceptions of integrating the tool within their clinical practice. Interview data were analyzed using a hybrid thematic analysis and guided by the Technology Acceptance Model. Data from thirteen providers from three distinct primary care sites were included in the presented study.ResultsThree core themes were identified: (1) Perceived usefulness: perceptions of the tool’s alignment with providers’ typical approach to care, impact and value and fit with existing workflows influenced providers’ intention to use the tool and usage behaviour; (2) Behavioural intention: providers had a high or low behavioural intention, and for some, it changed over time; and (3) Improving usage behaviour: enabling external factors and enhancing the tool’s perceived ease of use may improve usage behaviour.ConclusionsMultiple refinements/iterations of the ePRO tool (e.g. enhancing the tool’s alignment with provider workflows and functions) may be needed to enhance providers’ usage behaviour, perceived usefulness and behavioural intention. Enabling external factors, such as organizational and IT support, are also necessary to increase providers’ usage behaviour. Lessons from this study advance knowledge of technology implementation in primary care.Trial registrationClinicaltrials.gov Identified NCT02917954. Registered September 2016, https://www.clinicaltrials.gov/ct2/show/study/NCT02917954

224. Utilization of an automated SMS-based electronic patient-reported outcome tool in spinal surgery patients

<h3>BACKGROUND CONTEXT</h3> Recent evidence suggests that collecting and tracking patient-reported outcomes (PROs) are correlated with improved patient quality of life, patient satisfaction and physician-patient communication. With the ongoing shift in the health care industry to value-based care, more emphasis is placed on patient-reported measures as well as clinical outcomes and cost reduction methods. Typically, PROs are collected via paper forms, but this method has been shown to be difficult to incorporate and a burden on clinical staff and patients. The literature is scarce regarding the value of using electronic Patient Reported Outcome (ePRO) systems in nonclinical trial settings, and much of the existing literature focuses on phone applications that require installation. We sought to assess the usability of an automated app-less SMS-based electronic tool to collect spine PROs. <h3>PURPOSE</h3> To assess the feasibility of implementing an automated SMS-based electronic Patient Reported Outcome (ePRO) tool for clinical outcome assessment in spinal surgery patients. <h3>STUDY DESIGN/SETTING</h3> Patients receiving the SMS HIPAA-compliant survey link were prospectively enrolled in the ePRO tool's administrative web portal from June 1, 2020, to October 1, 2020. Outcome data for patients receiving either the SMS or paper survey was retrospectively analyzed. <h3>PATIENT SAMPLE</h3> A total of 204 patients were included in this study. Group1 included 88 patients who underwent either a microdiscectomy (9), lumbar fusion (42), or anterior cervical fusion (37) from June 1, 2020, to October 1, 2020, and were sent an outcome survey via a SMS HIPAA-compliant link. Group 2 included 116 patients who received either a microdiscectomy (14), lumbar fusion (69) or anterior cervical fusion (34) from November 1, 2019 to March 1, 2020, and were administered an in-office paper outcome survey. <h3>OUTCOME MEASURES</h3> Two outcomes were investigated in this study: survey compliance rate (response rate) and total mean time required for patient outcome assessment (includes mean survey response time and mean staff administration time). <h3>METHODS</h3> A total of 88 patients undergoing microdiscectomies (9), lumbar fusions (42), and anterior cervical fusions (37) from June 1, 2020, to October 1, 2020 were prospectively enrolled in the tool's administrative web portal. Patients received automated outcome assessment surveys via a HIPAA-compliant SMS link at 1 week, 1 month, and 3 months post-surgery. Once the patient clicked on the SMS link, they were led to a secure web browser in which they were able to complete the survey. All survey responses were captured in a secure web portal which allowed physicians and associated staff to view responses. Prior to the application of the ePRO tool, outcome information was collected at the aforementioned timepoints via paper for 116 patients who received microdiscectomies (14), lumbar fusions (69) and anterior cervical fusions (34) from November 1, 2019 to March 1, 2020. In this study, compliance rate and the mean time required for outcome assessment were compared between patients receiving SMS surveys and patients receiving paper surveys. Both groups of patients (SMS vs paper) had analogous demographic, medical history, and surgical characteristics. Data analysis was conducted in SPSS 20.0 (SPSS, Inc. Chicago, IL) and included one-way ANOVAs and two-tailed t-tests. <h3>RESULTS</h3> The PRO data capture rate was 52% with SMS surveys (146/279) and 26% (94/356) with paper surveys (p < 0.05). The total mean time associated with capturing outcomes via SMS surveys (19 hours) was one-third of the time associated with the paper survey method (57 hours) (p < 0.05). Use of the ePRO tool resulted in a reduction in both the mean survey completion time (SMS: 5 minutes, paper: 7.5 minutes) and mean administration time spent by staff on each patient (SMS: 5 minutes, Paper: 17 minutes). Minimal time effort was required from staff after initial patient enrollment. A survey assessing usability was administered to clinical staff (n=10) and patients (n=88); all staff and patients indicated a preference for use of the ePRO tool compared to the in-office paper survey. <h3>CONCLUSIONS</h3> Initial results indicate that implementation of an app-less SMS-based ePRO tool in a spine practice setting is feasible and mutually beneficial to patients and providers. SMS survey administration of PROs for spine surgery patients increased the capture rate of clinical outcomes, allowed for data collection in the absence of an office visit, and decreased the total mean time associated with PRO collection. The ePRO tool allowed for large-scale and timely data collection, and we believe use of such a tool can potentially facilitate early detection of patient issues and complications. Future studies would benefit by examining the value of using such a tool to identify patient complications in a timely manner. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

P-235 E-health monitoring during pancreatic cancer treatment

Technologies of digital support for oncological patients through mobile applications is a trend. The so-called “e-health” is already a reality in hospitals across the world. The WeCancer App is an electronic patient-reported outcome tool, which also provides on-demand multidisciplinary digital support from nurses, psychologists, and nutritionists. It also encompasses real-time remote patient monitoring, a notification center to patient and medical staff, symptom monitoring, medication control, and a content hub with reliable medical information. This study examined whether daily symptom reporting (with electronic patient-reported outcomes [e-PROs]) in pancreatic cancer patients is feasible. Patients could report sixteen common symptoms through a mobile application, on their smartphones and tablets, for monitoring, symptom management, and follow-up with a specialized nurse, who determines care based on digital support clinical protocols through online chat. The nursing team action started at the moment of patient inclusion with the tutorial to download the App and training with the patient/caregiver. From January 2020 to March 2021, 44 eligible patients were enrolled in this study. The e-PRO completion rates were > 90% at baseline, and ≥ 50% at all on-treatment assessments and adherence. In App adherence, 99 reports were made. 53 (53,54%) symptoms, 14 (14,14%) sleep, 12 (12,12%) weight, and 7 (7,07%) gratitude. The most reported symptoms were: tiredness (18,87%), pain (16,98%), dysphagia (9,43%), nausea (7,55%). Pancreatic cancer patients' reports are feasible through e-health. The results suggest that further research should be done to prove the effectiveness of the App.

Electronic patient reports outcomes and symptom monitoring for hematopoietic stem cell transplantation: A PILOT study.

e13592 Background: Patients undergoing hematopoietic stem cell transplantation (HSCT) present with various symptoms during hospitalization. The daily life routines of those undergoing HSCT change significantly before, during, and after the transplant. The utilization of technologies of digital support for oncological patients through mobile applications is a trend. WeCancer App is an electronic patient-reported outcome tool that provides on-demand multidisciplinary digital support by nurses, psychologists, and nutritionists. It also encompasses real-time remote patient monitoring, a notification center to the patient and medical staff, symptom monitoring, medication control, and a content hub with reliable medical information. Methods: This study examined whether electronic patient-reported outcomes [e-PROs]) in post-HSCT patients (6 patients included) up to 16 weeks after hospital discharge. The following were observed: number of symptoms reported, specific symptoms, toxicity after transplantation, application adherence, number of accesses, chat interactions, total hours of chat time. Patients could report common symptoms through a mobile application, for monitoring, symptom management, and follow-up with a specialized nurse, determining care based on digital support clinical protocols through online chat. The alerts made through the chat system guided the nursing team's clinical actions about online clinical management that can stratify the risk by crossing the intensity of symptoms by the ESAS scale (Manchester classification) and promoting preventive educational conduct of vigilance and risk mitigation. Results: Median follow-up for overall treatment was 16 weeks. The e-PRO completion rates were &gt; 90% at baseline and ≥ 80% at all on-treatment assessments and adherence. In-App adherence 329 reports were made 218 (66.26%) symptoms, 66 (20.06%) wellness, 30 (9.11%) gratitude and 15 (4.6%) exercise. Of the 64 chat interactions, there were 19.25 total hours and 18.05 average minutes per patient. The chat questions and interactions reported were: 48.2% symptoms, 27.7% treatment questions, 9.6% exams, 7.2% emotional aspect, 6% nutritional aspect and 1.3% medical devices. Some monitored patients (2) had guidance on outpatient graft versus host disease (GvHD) early in its onset with success avoiding a visit to the office or emergency room. Conclusions: We show the real-life benefits of incorporating ePRO into a post HSCT strategy adjunct to the treatment center. Symptoms that would only be brought to the physician in the next appointment were communicated in real-time to the transplant team, permitting early intervention and likely to reduce transplant-related deterioration and later interventions. The results suggest that further research should be done to prove the effectiveness of the App.

Electronic patient reported outcome in Brazil: Insurance provider impact on adherence.

e13590 Background: Routine monitoring of cancer patients' symptoms during their journey can improve symptom management, quality of life, and survival. Wecancer App is an electronic patient-reported outcome tool, which also provides on-demand multidisciplinary digital support by nurses, psychologists and nutritionists. It also encompasses real time remote patient monitoring, symptoms diary to patient and medical staff, symptom monitoring, medication control and a content hub with reliable information. It is free to any patient who download the app. In this study, we aim to understand if insurance provider type (private, public or out of pocket) impact on app adherence. Methods: This study examined daily symptom reporting (with electronic patient-reported outcomes [e-PROs]) patterns in breast cancer patients, according to insurance provider. The following were observed: app adherence, numbers of reports, chat interactions, specific symptoms, symptoms alerts and wellness reports. Patients could report sixteen common symptoms through a mobile application, on their smartphones and tablets, for monitoring, symptom management and follow-up with a specialized nurse, determining care based on digital support clinical protocols through online chat. The nursing team action started at the moment of patient inclusion with the tutorial to download the App and training it with the patient/caregiver. The alerts made through the chat system guided the clinical actions of the nursing team in relation to online clinical management that can stratify the risk by crossing the intensity of symptoms by the CTCAE grading scale and PRO-CTCAE Measurement System and promote preventive educational conduct of vigilance and risk mitigation. Results: From January 2020 to January 2021, 543 female eligible patients downloaded the app. The e-PRO completion rates were superior to 90% at baseline, and 55.47% completed all on-treatment assessments. The app adherence for private insurance patients (PIP), 37.06% for public insurance patients (PIP) and 7.45% for out of pocket patients (OPP). 2,626 reports were made (46.41% IP; 28.58% OPP; 25% PHP); 1008 chat interactions (52.18% IP; 40.28% PHP; 7.54% OPP); 1144 number of symptoms reported (46,41% IP; 28.58% OPP; 25% PHP); specific symptoms most reported in all kind of service was tiredness, pain, nausea, tingling; 547 symptoms alerts (54.84% IP; 35.46% PHP; 9.7% OPP) and 451 wellness reports (55.43% IP; 35.03% PHP; 9.53% OPP). Conclusions: Private insurance patients are more adherent to ePROS than public insured or out of pocket patients. Lack of free internet access and digital literacy could be impacting on adherence and, ultimately, quality of life and survival. Further studies are warranted to understand how to improve equality for digital health tools.

Utilization of an automated sms-based electronic patient reported outcome tool in spinal surgery patients

Utilization of an automated sms-based electronic patient reported outcome tool in spinal surgery patients

The use of patient-reported outcomes to detect adverse events in metastatic melanoma patients receiving immunotherapy: a randomized controlled pilot trial

BackgroundA randomized controlled pilot trial was conducted to assess if melanoma patients treated with immunotherapy had the number of grade 3 or 4 adverse events during treatment reduced by 50% using a tailored electronic patient-reported outcomes tool in addition to standard toxicity monitoring compared to standard monitoring alone. Secondary endpoints were: if more AEs were reported in the intervention group, if there was a difference between the two groups in the number of telephone consultations, extra out-patient visits, number of days in the hospital, days in steroid treatment and the time patients experienced grade 2 or higher toxicity.Patients and methodsMelanoma patients receiving immunotherapy at the Department of Oncology, Odense University Hospital, Denmark participated. Standard care included assessment of AEs by a clinician before each treatment cycle using the Common Terminology Criteria for Adverse Events. In addition, patients randomized to the intervention reported their AEs weekly by an electronic PRO-tool based on the PRO-CTCAE platform.ResultsOne hundred forty-six melanoma patients were randomized. In this study, we did not detect a difference between the two groups in the number of grade 3 or 4 AEs (P = 0.983), in the overall number of AEs (P = 0.560) or in the time the patients in the two groups experienced grade 2 or higher toxicity (0.516). The number of phone contacts was significantly higher in the intervention group (P = 0.009) and there was a tendency towards patients in the intervention group having more extra visits (P = 0.156).ConclusionIt has been examined if the number of severe AEs for melanoma patients receiving immunotherapy could be reduced by involving the patients in the reporting of symptoms. The results do not justify the expansion of the pilot study into a regular phase III study with this particular set-up. However, a significant difference in the number of phone contacts was found as patients in the intervention group called more frequently, indicating that their attention to AEs was increased. Even though the use of an electronic PRO tool could not reduce the number of severe AEs in this melanoma population, a positive impact on other endpoints such as QoL, communication, or treatment-planning, cannot be excluded.Trial registrationClinicaltrials.gov NCT03073031 Registered 8 March 2017, Retrospectively registered.

Follow-Up of Cancer Patients Receiving Anti-PD-(L)1 Therapy Using an Electronic Patient-Reported Outcomes Tool (KISS): Prospective Feasibility Cohort Study.

BackgroundImmune checkpoint inhibitors (ICIs) have become a standard of care for various tumor types. Their unique spectrum of side effects demands continuous and long-lasting assessment of symptoms. Electronic patient-reported outcome (ePRO) follow-up has been shown to improve survival and quality of life of cancer patients treated with chemotherapy.ObjectiveThis study aimed to investigate whether ePRO follow-up of cancer patients treated with ICIs is feasible. The study analyzed (1) the variety of patient reported symptoms, (2) etiology of alerts, (3) symptom correlations, and (4) patient compliance.MethodsIn this prospective, one-arm, multi-institutional study, we recruited adult cancer patients whose advanced cancer was treated with anti-programmed cell death protein 1 (PD)- ligand (L)1 agents in outpatient settings. The ePRO tool consisted of a weekly questionnaire evaluating the presence of typical side effects, with an algorithm assessing the severity of the symptom according to National Cancer Institute Common Terminology Criteria for Adverse Events and an urgency algorithm sending alerts to the care team. A patient experience survey was conducted monthly. The patients were followed up to 6 months or until disease progression.ResultsA total of 889 symptom questionnaires was completed by 37 patients (lung cancer, n=15; melanoma, n=9; genitourinary cancer, n=9; head and neck cancer, n=4). Patients showed good adherence to ePRO follow-up. The most common grade 1 symptoms were fatigue (28%) and itching (13%), grade 2 symptoms were loss of appetite (12%) and nausea (12%), and grade 3-4 symptoms were cough (6%) and loss of appetite (4%). The most common reasons for alerts were loss of appetite and shortness of breath. In the treatment benefit analysis, positive correlations were seen between clinical benefit and itching as well as progressive disease and chest pain.ConclusionsAccording to the results, ePRO follow-up of cancer patients receiving ICIs is feasible. ePROs capture a wide range of symptoms. Some symptoms correlate to treatment benefit, suggesting that individual prediction models could be generated.Trial RegistrationClinical Trials Register, NCT3928938; https://clinicaltrials.gov/ct2/show/NCT03928938

Seeking Meaningful Innovation: Lessons Learned Developing, Evaluating, and Implementing the Electronic Patient-Reported Outcome Tool.

Digital health solutions, in particular information communication technologies, often experience implementation failures leading to slower adoption than expected. This implementation challenge has spurred the development of frameworks to help navigate this uncertain and messy process. These frameworks point to environmental, organizational, individual, and technological factors that can drive or hinder implementation, with some in the field suggesting that perceived value may play a pivotal role. However, the concept of value can have varying meanings and be challenging to operationalize as a means to support implementation. Attending to philosophical and psychological meaningfulness for users and organizations in which technologies are adopted may offer a useful lens, by linking perceived value to individual behavior changes often required as part of implementing digital health technologies. Lessons learned from developing, evaluating, and implementing the electronic Patient-Reported Outcome (ePRO) tool demonstrate how qualitative methods can be used to uncover meaningfulness. By drawing from this example and other similar studies, this viewpoint offers suggestions on how future inquiry could deepen an understanding of meaningful innovation to help drive the implementation of digital health technologies.

Adoption patterns of an electronic patient-reported outcomes tool in oncology.

e19127 Background: Patient-reported outcomes (PROs) are critical for the delivery of patient-centric care. Previous research has shown that the use of PROs can impact clinical outcomes in Oncology. Despite these benefits, PROs have not been widely implemented as part of standard of care. Significant barriers exist for its adoption including lack of integration between PRO tools and electronic health record systems (EHRs). We developed MSK Engage, a home-grown PRO tool integrated with the EHR and embedded within MSK's patient portal (MyMSK). It was launched in late 2015 and it is currently used enterprise-wide for both standard of care and research purposes. The purpose of this study was to describe the usage patterns of PROs in a real-world setting. Methods: We conducted a retrospective analysis of patients that have been assigned at least one MSK Engage survey instrument between 2015 and 2019. Patient demographic information was extracted from the EHR system. Usage patterns including the number of survey instruments assigned and completed were extracted from MSK Engage. Survey completion rates were stratified by patient demographic information and number of assigned surveys. We performed univariate and multivariate analyses to identify factors associated with survey completion rates. Results: During the study period, 57 survey instruments were implemented, with the majority being used for standard of care (41 for standard of care only, 9 for research protocols, 6 for standard of care and research, and one for a quality improvement initiative). In total, 246,638 patients were assigned 557,559 surveys. Of those, 146,505 patients completed a total of 265,174 surveys, with a median completion time of 3 minutes. Among the patients that were assigned a survey, 73.7% were women. Women in our sample were older than men, with median age 52 and 47 years old, respectively. Men were more likely to complete the assigned surveys with 61.2% completion rate among men and 43.3% among women (p &lt; 0.001). On multivariate analysis, men were less likely to miss surveys than women (odds ratio [OR], 0.49; 95% CI, 0.48-0.49). We also identified a significant correlation between the survey completion rate and number of assigned surveys, demonstrating that assigning a large number of surveys for each patient can lead to a reduced survey response. Conclusions: Providers have quickly adopted MSK Engage demonstrating that it is feasible to incorporate PROs as part of standard of care. Patients are willing to answer PROs; however, it is important to mindful when assigning surveys to avoid negative effects of survey burden.

Using Exploratory Trials to Identify Relevant Contexts and Mechanisms in Complex Electronic Health Interventions: Evaluating the Electronic Patient-Reported Outcome Tool.

BackgroundDesigning appropriate studies for evaluating complex interventions, such as electronic health solutions to support integrated care, remains a methodological challenge. With the many moving parts of complex interventions, it is not always clear how program activities are connected to anticipated and unanticipated outcomes. Exploratory trials can be used to uncover determinants (or mechanisms) to inform content theory that underpins complex interventions before designing a full evaluation plan.ObjectiveA multimethod exploratory trial of the electronic patient-reported outcome (ePRO) tool was conducted to uncover contexts, processes and outcome variables, and the mechanisms that link these variables before full-scale evaluation. ePRO is a mobile app and portal designed to support goal-oriented care in interdisciplinary primary health care practices (clinical-level integration). This paper offers evaluation findings and methodological insight on how to use exploratory trial data to identify relevant context, process, and outcome variables, as well as central (necessary to achieving outcomes) versus peripheral (less critical and potentially context dependent) mechanisms at play.MethodsThe 4-month trial was conducted in 2 primary health care practices in Toronto, Canada. The patients were randomized into control and intervention groups and compared pre and post on quality of life and activation outcome measures. Semistructured interviews were conducted with providers and patients in the intervention group. Narrative analysis was used to uncover dominant mechanisms that inform the intervention’s content theory (how context and process variables are linked to outcomes).ResultsOverall, 7 providers, 1 administrator, and 16 patients (7-control, 9-intervention) participated in the study. This study uncovered many complex and nuanced context, process, and outcome variables at play in the intervention. Narrative analysis of patient and provider interviews revealed dominant story lines that help to tease apart central and peripheral mechanisms driving the intervention. Provider and patient story lines centered around fitting the new intervention into everyday work and life of patients and providers and meaningfulness of the intervention. These themes were moderated by patient-provider relationships going into and throughout the intervention, their comfort with technology, and the research process.ConclusionsIdentifying dominant story lines using narrative analysis helps to identify the most relevant context and process variables likely to influence study outcomes. Normalization process theory emerges as a useful theory to uncover underlying mechanisms because of its emphasis on the social production and normalization of technological, processual, and social aspects of work; all found to be critical to our intervention. The number of complex, overlapping influencing variables suggests that complex interventions such as ePRO require us to pay careful attention to central versus peripheral mechanisms that will influence study outcomes. The narrative methods presented here are shown to be useful in uncovering these mechanisms and help to guide subsequent larger evaluation studies.

An Electronic Patient-Reported Outcome Tool for the FACT-B (Functional Assessment of Cancer Therapy-Breast) Questionnaire for Measuring the Health-Related Quality of Life in Patients With Breast Cancer: Reliability Study.

BackgroundThe most frequent malignant disease in women is breast cancer. In the metastatic setting, quality of life is the primary therapeutic goal, and systematic treatment has only a limited effect on survival rates; therefore, the concept of the health-related quality of life (HRQoL) and measurement of patient-reported outcomes (PROs) are gaining more and more importance in the therapy setting of diseases such as breast cancer. One of the frequently used questionnaires for measuring the HRQoL in patients with breast cancer is the Functional Assessment of Cancer Therapy-Breast (FACT-B). Currently, paper-based surveys still predominate, as only a few reliable and validated electronic-based questionnaires are available. ePRO tools for the FACT-B questionnaire with proven reliability are missing so far.ObjectiveThe aim of this study was to analyze the reliability of tablet-based measurement of FACT-B in the German language in adjuvant (curative) and metastatic breast cancer patients.MethodsPaper- and tablet-based questionnaires were completed by a total of 106 female adjuvant and metastatic breast cancer patients. All patients were required to complete the electronically based (ePRO) and paper-based version of the FACT-B. A frequency analysis was performed to determine descriptive sociodemographic characteristics. Both dimensions of reliability (parallel forms reliability using Wilcoxon test and test of internal consistency using Spearman ρ) and agreement rates for single items, Kendall tau for each subscale, and total score were analyzed.ResultsHigh correlations were shown for both dimensions of reliability (parallel forms reliability and internal consistency) in the patients’ response behavior between paper-based and electronically based questionnaires. Regarding the reliability test of parallel forms, no significant differences were found in 35 of 37 single items, while significant correlations in the test for consistency were found in all 37 single items, in all 5 sum individual item subscale scores, as well as in total FACT-B score.ConclusionsThe ePRO version of the FACT-B questionnaire is reliable for patients with breast cancer in both adjuvant and metastatic settings, showing highly significant correlations with the paper-based version in almost all questions all subscales and the total score.