Electronic Patient-reported Outcomes System Research Articles

Implementation and impact of an electronic patient reported outcomes system in a phase II multi-site adaptive platform clinical trial for early-stage breast cancer.

We describe the development and implementation of a system for monitoring patient-reported adverse events and quality of life using electronic Patient Reported Outcome (ePRO) instruments in the I-SPY2 Trial, a phase II clinical trial for locally advanced breast cancer. We describe the administration of technological, workflow, and behavior change interventions and their associated impact on questionnaire completion. Using the OpenClinica electronic data capture system, we developed rules-based logic to build automated ePRO surveys, customized to the I-SPY2 treatment schedule. We piloted ePROs at the University of California, San Francisco (UCSF) to optimize workflow in the context of trial treatment scenarios and staggered rollout of the ePRO system to 26 sites to ensure effective implementation of the technology. Increasing ePRO completion requires workflow solutions and research staff engagement. Over two years, we increased baseline survey completion from 25% to 80%. The majority of patients completed between 30% and 75% of the questionnaires they received, with no statistically significant variation in survey completion by age, race or ethnicity. Patients who completed the screening timepoint questionnaire were significantly more likely to complete more of the surveys they received at later timepoints (mean completion of 74.1% vs 35.5%, P < .0001). Baseline PROMIS social functioning and grade 2 or more PRO-CTCAE interference of Abdominal Pain, Decreased Appetite, Dizziness and Shortness of Breath was associated with lower survey completion rates. By implementing ePROs, we have the potential to increase efficiency and accuracy of patient-reported clinical trial data collection, while improving quality of care, patient safety, and health outcomes. Our method is accessible across demographics and facilitates an ease of data collection and sharing across nationwide sites. We identify predictors of decreased completion that can optimize resource allocation by better targeting efforts such as in-person outreach, staff engagement, a robust technical workflow, and increased monitoring to improve overall completion rates. https://clinicaltrials.gov/study/NCT01042379.

Early resolution of bowel urgency by budesonide foam enema results in improved quality of life in patients with ulcerative colitis: a multicenter prospective observational study.

Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC. This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed. Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%-71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%-76.4%). One adverse event not related to budesonide rectal foam occurred. The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.

Chat-ePRO: Development and pilot study of an electronic patient-reported outcomes system based on ChatGPT

ObjectiveChatbots have the potential to improve user compliance in electronic Patient-Reported Outcome (ePRO) system. Compared to rule-based chatbots, Large Language Model (LLM) offers advantages such as simplifying the development process and increasing conversational flexibility. However, there is currently a lack of practical applications of LLMs in ePRO systems. Therefore, this study utilized ChatGPT to develop the Chat-ePRO system and designed a pilot study to explore the feasibility of building an ePRO system based on LLM. Materials and MethodsThis study employed prompt engineering and offline knowledge distillation to design a dialogue algorithm and built the Chat-ePRO system on the WeChat Mini Program platform. In order to compare Chat-ePRO with the form-based ePRO and rule-based chatbot ePRO used in previous studies, we conducted a pilot study applying the three ePRO systems sequentially at the Sir Run Run Shaw Hospital to collect patients’ PRO data. ResultChat-ePRO is capable of correctly generating conversation based on PRO forms (success rate: 95.7 %) and accurately extracting the PRO data instantaneously from conversation (Macro-F1: 0.95). The majority of subjective evaluations from doctors (>70 %) suggest that Chat-ePRO is able to comprehend questions and consistently generate responses. Pilot study shows that Chat-ePRO demonstrates higher response rate (9/10, 90 %) and longer interaction time (10.86 s/turn) compared to the other two methods. ConclusionOur study demonstrated the feasibility of utilizing algorithms such as prompt engineering to drive LLM in completing ePRO data collection tasks, and validated that the Chat-ePRO system can effectively enhance patient compliance.

Barriers and Facilitators to the Implementation of an Electronic Patient-Reported Outcome System at Cancer Hospitals in Japan.

Background and objective Implementing electronic patient-reported outcomes (ePROs) in oncology practice has shown substantial clinical benefits. However, it can be challenging in routine practice, warranting strategies to adapt to different clinical contexts. In light of this, this study aimed to describe the implementation process of the ePRO system and elucidate the provider-level implementation barriers and facilitators to a novel ePRO system at cancer hospitals in Japan. Methods We implemented an ePRO system linked to electronic medical records at three cancer hospitals. Fifteen patients with solid cancers at the outpatient oncology unit were asked to regularly complete the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) questionnaire and European Organization for Research and Treatment Core Quality of Life questionnaire (EORTC QLQ C30) by using the smartphone app between October 2021 and June 2022. Thirteen healthcare professionals were interviewed to identify implementation barriers and facilitators to the ePRO system by using the Consolidated Framework for Implementation Research framework. Results The healthcare professionals identified a lack of clinical resources and a culture and system that emphasizes treatment over care as the main barriers; however, the accumulation of successful cases, the leadership of managers, and the growing needs of patients can serve as facilitators to the implementation. Conclusions Our experience implementing an ePRO system in a few Japanese oncology practices revealed comprehensive barriers and facilitators. Further efforts are warranted to develop more successful implementation strategies.

Suicidal ideation in Chinese patients with advanced breast cancer: a multi-center mediation model study

PurposeThe pathways underpinning suicide ideation (SI) and certain physical and psychological factors in patients with advanced breast cancer remain unclear. This study develops and validates a mediation model that delineates the associations between several multidimensional variables and SI in Chinese patients with advanced breast cancer.MethodsPatients with advanced breast cancer (n = 509) were recruited as study participants from 10 regional cancer centers across China from August 2019 to December 2020. Participants were required to complete five questionnaires using an electronic patient-reported outcomes (ePRO) system: 9 item- Patient Health Questionnaire (PHQ-9), Hospital Anxiety and Depression Scale (HADS), Insomnia Severity Index (ISI), 5-level EQ-5D (EQ-5D-5L), and MD Anderson Symptom Inventory (MDASI). Risk factors for SI were identified using multivariable logistic regression, and inputted into serial multiple mediation models to elucidate the pathways linking the risk factors to SI.ResultsSI prevalence was 22.8% (116/509). After adjusting for covariates, depression (odds ratio [OR] = 1.384), emotional distress (OR = 1.107), upset (OR = 0.842), and forgetfulness (OR = 1.236) were identified as significant independent risk factors (all p < 0.05). The ORs indicate that depression and distress have the strongest associations with SI. Health status has a significant indirect effect (OR=-0.044, p = 0.005) and a strong total effect (OR=-0.485, p < 0.001) on SI, mediated by insomnia severity and emotional distress.ConclusionsThere is a high SI prevalence among Chinese patients with advanced breast cancer. Our analysis revealed predictive pathways from poor health to heightened SI, mediated by emotional distress and insomnia. Regular management of distress and insomnia can decrease suicide risk in this vulnerable population.

Patient perspective on living with mild hemophilia in Germany: results from a nationwide survey.

The disease burden and bleeding risk of patients with mild hemophilia may be underestimated. Their health-related quality of life (QoL) may be negatively impacted by insufficient treatment and bleed-related joint damage connected to a potentially delayed diagnosis. This study aims to gain information on the care reality and QoL of patients aged ≥12 years with mild hemophilia in Germany. An anonymous cross-sectional patient survey using standardized questionnaires was conducted in a validated electronic patient-reported outcome system. Medical specialists, hemophilia centers, patient organizations, and support groups across Germany invited the patients. A total of 43 patients (35 patients with hemophilia A, 5 patients with hemophilia B, and 3 patients for whom the information was missing) with a median age of 33 years were analyzed. The median age at diagnosis was 6.0 years (interquartile range [IQR] 2.0-15.0), and the median factor activity was 14.0% (IQR 12.0-25.0). Nearly 85% of the patients received factor concentrates in the past, and the most common reasons for the treatment were surgery or joint bleeding (each 65.6%). Half of the patients who provided feedback experienced complications during bleeding episodes. Prophylactic treatment with factor concentrates was rare (10.3%). The patients had minor problems regarding their health status. Bleeding complications and joint bleeding, in particular, may be highly underestimated in patients with mild hemophilia, highlighting a medical need in this population. Patients with a potential benefit from prophylaxis need to be identified. Mild hemophilia has a negative impact on patients' QoL. Hemophilia centers satisfied the patients' needs. Further research is needed to address the current lack of awareness and improve adequate treatment in the future.

Motivation for and feasibility of postoperative electronic patient-reported outcome symptom monitoring in thoracic surgery patients: A qualitative study.

337 Background: Digital health systems can be used to engage patients in remote symptom monitoring to support their postoperative care, but understanding of patient motivation and experiences monitoring their symptoms after thoracic surgery are limited. We enrolled patients who had undergone thoracic surgery in an electronic patient-reported outcome (ePRO) system. We report our qualitative findings about their motivation for and feasibility of ePRO symptom monitoring. Methods: In-depth interviews were conducted by phone with adult patients who had undergone thoracic surgery and enrolled in ePROs. Patients were sent 10-item ePRO surveys twice weekly for 2 weeks and then weekly for 4 weeks after returning home, with clinicians alerted about severe symptoms. Interviews focused on understanding patients' motivation for completing ePROs, experience with completing, and perceived importance of ePROs. The interview guide and data analysis were informed by the Capability, Opportunity, Motivation model for behavior change (COM-B) and the Theoretical Domains Framework (TDF). Interviews were audio recorded, transcribed verbatim, and four team members used a coding-based content analysis to identify emerging themes. Themes were discussed with the project team and used to identify opportunities to improve patients’ experiences with ePROs. Results: From July-October 2022, we interviewed 25 patients, of whom more than half (56%) had a history of lung cancer or another malignancy. Participants had a mean age of 58 years, were 56% female, 80% White, and 12% Black, and completed a mean of 5.2 out of 6 possible ePRO surveys. Motivating factors for completing ePROs included receiving a direct response from their clinical team to their reported symptoms; wanting to support their clinical team in understanding patients’ full recovery journey to improve care; and, the emotional benefits of tracking their progress and feeling more seen/less alone. There was some concern over creating unnecessary follow-ups for their care teams by reporting symptoms. For feasibility, participants reported the ease and convenience of completing ePROs, though some cautioned that standardized ePROs may not capture the complexities of their experiences, and that ePRO completion can be emotionally burdensome if reminded of a painful experience. Regarding perceived importance, participants recommended ePROs for other patients as a way to set expectations for their health experiences and improve care for themselves and others. Conclusions: Patients generally described being motivated to complete ePROs, and found ePROs relatively feasible to complete and valuable to the post-discharge care experience. Consideration of how ePROs can be used to better set expectations for symptom burden and capture patients’ complex health experiences may support long-term surgical oncology care.

Patient-reported outcomes in patients with primary immunodeficiency diseases in Japan: baseline results from a prospective observational study.

Primary immunodeficiency diseases (PIDs) are rare inherited diseases resulting in impaired immunity. People with PID experience lower health-related quality of life (HR-QOL) and disease-related burdens in daily activities. This ongoing, prospective observational study aims to evaluate disease activity, treatment status, treatment-related burden, daily activities, and HR-QOL in patients with PID in Japan over a 1-year period. In this interim report (database lock: July 29, 2022), we present baseline results. Participants were enrolled between November 2021 and May 2022; data were collected four times/year per participant until May 2023 using an online electronic patient-reported outcomes system. Patients with PID and healthy volunteers aged ≥12 years, residing in Japan, and with access to a smartphone were eligible. HR-QOL (primary endpoint) was assessed by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) and the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). Work productivity was assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire. Other aspects of PID and burden were assessed with a new questionnaire developed in-house. The study is registered at the University hospital Medical Information Network clinical trials registry (UMIN000045622). The full interim analysis set comprised 71 patients with PID and 47 healthy volunteers. The most common International Union of Immunological Societies PID category was primary antibody deficiency (56.3% of patients). Complications were common, especially recurrent respiratory tract infections (63.4%). Most patients with PID were treated with immunoglobulin replacement therapy (73.2%); 22.4% of these patients had serum immunoglobulin levels <700 mg/dL. Among patients who did not undergo hematopoietic cell transplantation, EQ-5D-5L (n=67) and SF-36 (n=59) Physical and Mental Component Summary scores were significantly lower than in healthy volunteers (p < 0.001). WPAI absenteeism, work productivity loss, and activity impairment scores were significantly lower in 42 working patients with PID than in 37 working healthy volunteers (p < 0.05). Other results indicated that patients with PID experience substantial burdens related to medical visits, expenses, work, and daily activities. This interim analysis confirms that patients with PID in Japan have lower HR-QOL and work productivity compared with healthy individuals and experience substantial limitations and burdens in their daily lives.

Usability testing of an electronic patient-reported outcome system linked to an electronic chemotherapy prescribing and patient management system for patients with cancer

BackgroundPeople affected by cancer experience a wide range of symptoms which have a major impact on their functioning and health-related quality of life (HRQoL). One way to measure the impact of cancer symptoms is through the use of patient-reported outcomes. MethodsAn electronic patient-reported outcome (ePRO) application (ChemoPRO®) was designed to be used by cancer patients to report their symptoms and communicate with their clinical team. Usability testing sessions were conducted with people with lived experience of cancer to understand how real users interact with the ChemoPRO® system. One-to-one testing sessions were conducted to assess use of the system and identify areas for further refinement. User satisfaction was assessed using a brief satisfaction questionnaire previously used by Aiyegbusi et al. (date). ResultsTen people with lived experience of cancer took part in the usability study. Symptoms and HRQoL measures, including the Euroqol EQ5D5L and the PRO-CTCAE™ were included in the ePRO system. Participantshad a mean age of 62.3 years. Three critical errors and 21 non-critical errors were reported. All participants were enthusiastic about the app. Participants liked the simplicity and responsiveness of the patient-facing app and highlighted the potential for communicating with their clinical team. The overall usability and satisfaction score was 4.5 (sd = 0.09). ConclusionThis usability study suggests that people with lived experience of cancer found the ChemoPRO® app acceptable and easy to use. One of the key features of this particular ePRO system that should be developed further is system functionality to facilitate communication between patients and clinicians. Future testing should include testing in a clinical setting and testing with people from ethnic minorities.

Enhanced safety surveillance of GSK's quadrivalent seasonal influenza vaccine in Germany and Spain (2021/2022 season) using an electronic patient-reported outcome system for vaccine safety remote monitoring.

Seasonal influenza epidemics are managed through vaccination each winter in the European Union, to prevent infections, complications, and deaths. As circulating virus strains vary unpredictably, vaccines are reformulated annually, and their safety monitored rapidly and continuously at the start of each season, following European Medicines Agency guidelines.Seasonal influenza epidemics are managed through vaccination each winter in the European Union, to prevent infections, complications, and deaths. As circulating virus strains vary unpredictably, vaccines are reformulated annually, and their safety monitored rapidly and continuously at the start of each season, following European Medicines Agency guidelines. This enhanced safety surveillance study assessed pre-specified and other adverse events (AEs) occurring within 7 days of GSK's inactivated quadrivalent seasonal influenza vaccine (IIV4) in children and adults in Spain and Germany. As the study was conducted during the COVID-19 pandemic (2021/2022 season), data were collected electronically, using a web portal or call center. Safety was assessed in 737 participants (median age 49 and 9 years in Germany and Spain, respectively, 19.3% with a chronic medical condition). After Dose 1 and Dose 2, respectively, 332 (45.1%) and 5 (26.3%) participants reported at least one AE, primarily pre-specified AEs. The most common AEs after Dose 1 (adults and children) were injection site pain, swelling or erythema, headache, and fatigue. After Dose 2 (in children), the most common AEs were injection site pain, rhinorrhea, fatigue, and decreased appetite. No new or unexpected safety issues were identified. This study supports and confirms the safety profile of GSK's IIV4 in all age groups with a vaccine indication. The new electronic safety reporting method (with response rates of 75.4% following Dose 1 and 100% following Dose 2) provides an alternative for future studies to reduce the burden on sites or in case site visits are not feasible.

A RE-AIM Evaluation of a Visualization-Based Electronic Patient-Reported Outcome System.

Health care systems are primarily collecting patient-reported outcomes (PROs) for research and clinical care using proprietary, institution- and disease-specific tools for remote assessment. The purpose of this study was to conduct a Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) evaluation of a scalable electronic PRO (ePRO) reporting and visualization system in a single-arm study. The "mi.symptoms" ePRO system was designed using gerontechnological design principles to ensure high usability among older adults. The system enables longitudinal reporting of disease-agnostic ePROs and includes patient-facing PRO visualizations. We conducted an evaluation of the implementation of the system guided by the RE-AIM framework. Quantitative data were analyzed using basic descriptive statistics, and qualitative data were analyzed using directed content analysis. Reach-the total reach of the study was 70 participants (median age: 69, 31% female, 17% Black or African American, 27% reported not having enough financial resources). Effectiveness-half (51%) of participants completed the 2-week follow-up survey and 36% completed all follow-up surveys. Adoption-the desire for increased self-knowledge, the value of tracking symptoms, and altruism motivated participants to adopt the tool. Implementation-the predisposing factor was access to, and comfort with, computers. Three enabling factors were incorporation into routines, multimodal nudges, and ease of use. Maintenance-reinforcing factors were perceived usefulness of viewing symptom reports with the tool and understanding the value of sustained symptom tracking in general. Challenges in ePRO reporting, particularly sustained patient engagement, remain. Nonetheless, freely available, scalable, disease-agnostic systems may pave the road toward inclusion of a more diverse range of health systems and patients in ePRO collection and use.

A digital patient-reported outcome (electronic patient-reported outcome) system for patients with severe psychiatric disorders: User-centered development study and study protocol of a multicenter-controlled trial.

The effective treatment of patients with severe psychiatric disorders primarily relies on subjective reporting of symptoms and side-effects. This information is crucial for a clinician's decision regarding medication adjustment. Treatment adjustment usually happens at a low frequency (∼4-8 weeks). In between points of care, patients are left alone with their symptoms and side-effects. This leads to uncertainty regarding the treatment, non-adherence, possible relapse, and rehospitalization. We aim to design a flexible electronic patient-reported outcome (ePRO) system, which allows patients with severe psychiatric disorders to: (a) record their symptoms using an app; (b) share the data with the clinical team at points of care; and (c) utilize the data to support therapy decisions. In this article, we describe the development process which included the following steps: (a) formation of a co-design team; (b) stakeholder interviews with patients, practitioners, and digital health experts to access needs, requirements, and barriers; (c) prototype conceptualization and design; (d) user acceptance testing and refinement; and (e) finalization of the system for testing in a pilottrial. We included input from patients with lived experience of psychiatric disorders, clinical team members, software engineers, and researchers. A prototype system was refined, and iterative changes were made before finalization during a series of operational meetings. The system allows patients to digitally self-report their symptoms and provides longitudinal ePRO symptom data for export into the electronic health record. Routine ePRO collection has the potential to improve outcomes and hereby also reduce health service costs. We have successfully developed a trial-ready ePRO system for severe psychiatric disorders. The findings were incorporated in the planning of a feasibility pilot trial. Assuming feasibility will be established, the system might be subjected to a certification process evaluation of safety and efficacy including a randomized controlled trial.

Changes in Patient-Reported Health Status in Advanced Cancer Patients from a Symptom Management Clinic: A Longitudinal Study Conducted in China.

Objectives The integration of patient-reported health status has been increasingly emphasised for delivering high-quality care to advanced cancer patients. This research is designed to track health status changes over time in Chinese advanced cancer patients to explore the risk factors affecting their health status. Methods Advanced cancer patients were recruited from Peking University Cancer Hospital. An electronic patient-reported outcome (ePRO) system with validated measurements was used to collect the data. ANOVA, the chi-square test, the nonparametric Kruskal–Wallis H test, and generalized estimating equation (GEE) analysis were used for the data analysis. Results One hundred and three patients completed a baseline survey (T = 0) and two follow-up surveys (T1 = 14 days, T2 = 28 days). Chi-square test results indicate a significant decrease in the percentage of patients reporting moderate or severe difficulty experienced by patients in terms of mobility, pain/discomfort, and anxiety/depression. However, there is a significant increase in the percentage of patients reporting moderate or severe difficulty in self-care and usual activities. Scores on the visual analogue scale in the EQ-5D-5L instrument (EQ-VAS) are associated with patients' income, and the degree of moderate or severe anxiety/depression is found to be associated with employment status. The GEE results show that pain, loss of appetite, poor walking status effected by symptoms, depression, and anxiety has worsened the health status. Conclusions The health status of Chinese advanced cancer patients under ePRO follow-up in China significantly improves in the physical and psychological dimensions, accompanied by a decrease in usual activities and self-care. Routine screening and rational supportive care are recommended in oncology for cancer care. Based on the rational application of ePRO, longitudinal studies exploring the potential mechanisms of health status changing would provide more beneficial guidance for improving the quality of life in patients with advanced cancer.

Feasibility of a new electronic patient-reported outcome (ePRO) system for an advanced therapy clinical trial in immune-mediated inflammatory disease (PROmics): protocol for a qualitative feasibility study

IntroductionThe use of electronic patient-reported outcome (ePRO) systems to capture PRO data in clinical trials is increasing; however, their feasibility, acceptability and utility in clinical trials of advanced therapy medicinal...

MO926: Development and Implementation of an Electronic Patient-Reported Outcome System to Support Health-Related Quality of Life Management in a Large, European Dialysis Network

Abstract BACKGROUND AND AIMS Electronic patient-reported outcome measures (ePROMs) may help personalize healthcare for dialysis patients. ePROMs allow patients to self-report their symptoms and disease burden remotely and make the data available to healthcare professionals (HCP) in real-time. Such information can be used for digital phenotyping, symptoms and disease burden monitoring and to enable personalized healthcare through improved outcomes prediction, as well as Screen and Act, N-of-1 trials and treat-to-target approaches. However, routine use of ePROM in clinical practice presents several challenges, including respondent burden and a lack of clear guidance on medical and psycho-educational intervention in response to patients’ complains. We sought to implement a quality improvement programme based on ePROM management in a large network of dialysis patients. METHOD ePROM were collected as part of a screen and act programme launched for the first time in all centres belonging to the Fresenius Medical Care (FMC) Nephrocare network in France (FR), Italy (IT), Spain (SP), UK and Ireland (IR) starting on 20 September 2021. The screening phase ended on 4 December 2021. The action phase is still ongoing. The programme aims at screening all dialysis patients for undetected quality of life and adjustment problems and allow physicians, at their sole discretion, to provide remediation actions potentially including adjustment of treatment plan based on revision of patients’ clinical charts and administration of health education modules. The questionnaire included KDQOL-36, the 5D-Itch questionnaire and an ad hoc module on intradialytic symptoms, and its content was mapped to SONG-HD initiative endpoints. ePROM were collected at the bedside or at patients’ home with a web application available for tablet and smartphones either as self-report or assisted self-report. All ePROM data were recorded in EuCLiD®, the clinical information systems adopted by FMC Nephrocare clinics, as part of patients’ clinical chart. A dashboard displaying patients’ scores was shown to the attending healthcare professional upon survey completion. Statistics about patients’ engagement, scores and action alerts are presented in clinical reports. In the present analysis, we report a retrospective analysis of data abstracted from the EuCliD® database. RESULTS Overall, 152 centres (93%) joined the campaign. Participation statistics across countries are reported in Fig. 1. Among 11 537 active patients treated in the five participating countries, 1553 were ineligible because belonging to non-participating centres, temporarily transferred to other centres outside the network (i.e. vacation, rehabilitation, etc.), hospitalized, or because they were considered unable to respond to the survey (i.e. language barrier, inability to read and write or cognitive impairment). Around 23% (IT) to 30% (FR) were considered eligible with assisted administration only. Attrition rate ranged from 3% (IT) to 15% (FR). Item missingness was &amp;lt;2% for all items throughout the survey except for the item on sexual activity (&amp;gt;10% in all countries). KDQOL-36 scores are reported in Fig. 2; 22.5% reported moderate to very severe pruritus mostly distributed on the head/scalp, chest, abdomen, back, lower legs and thighs, forearm and upper arm (all &amp;gt;30% prevalence). Between 10% (IT) and 20% (UK) reported any complications during their last dialysis session, and between 6% (SP) and 12% (IR) suspended or interrupted treatment because of their symptoms. Prevalence of recovery time &amp;gt;3 h ranged from 34.8% (FR) to 46.4% (IR). CONCLUSION The ePROM quality improvement campaign attained wide participation and low attrition. We found no evidence of respondent burden given the low missingness rate throughout the survey items. The screening phase allowed to collect and organize a wealth of patient-reported outcomes amenable of medical or psycho-educational interventions.

Patient-Reported Outcome-Based Symptom Management Versus Usual Care After Lung Cancer Surgery: A Multicenter Randomized Controlled Trial.

We aimed to evaluate the efficacy and feasibility of patient-reported outcome (PRO)-based symptom management in the early period after lung cancer surgery. Before surgery, patients with clinically diagnosed lung cancer were randomly assigned 1:1 to receive postoperative PRO-based symptom management or usual care. All patients reported symptoms on MD Anderson Symptom Inventory-Lung Cancer presurgery, daily postsurgery, and twice a week after discharge for up to 4 weeks via an electronic PRO system. In the intervention group, treating surgeons responded to overthreshold electronic alerts driven by any of the five target symptom scores (score ≥ 4 on a 0-10 scale for pain, fatigue, disturbed sleep, shortness of breath, and coughing). The control group patients received usual care and no alerts were generated. The primary outcome was the number of symptom threshold events (any target symptom with a score of ≥ 4) at discharge. Per-protocol analyses were conducted. Of the 166 participants, 83 were randomly allocated to each group. At discharge, the intervention group reported fewer symptom threshold events than the control group (median [interquartile range], 0 [0-2] v 2 [0-3]; P = .007). At 4 weeks postdischarge, this difference was maintained between the intervention and control groups (median [interquartile range], 0 [0-0] v 0 [0-1]; P = .018). The intervention group had a lower complication rate than the control group (21.5% v 40.6%; P = .019). Surgeons spent a median of 3 minutes managing an alert. PRO-based symptom management after lung cancer surgery showed lower symptom burden and fewer complications than usual care for up to 4 weeks postdischarge.

Electronic patient-reported outcomes monitoring during lung cancer chemotherapy: A nested cohort within the PRO-TECT pragmatic trial (AFT-39)

ObjectivesPatients with lung cancer have high symptom burden and diminished quality of life. Electronic patient-reported outcome (PRO) platforms deliver repeated longitudinal surveys via web or telephone to patients and alert clinicians about concerning symptoms. This study aims to determine feasibility of electronic PRO monitoring in lung cancer patients receiving treatment in community settings. MethodsAdults receiving treatment for advanced or metastatic lung cancer at 26 community sites were invited to participate in a prospective trial of weekly electronic PRO symptom monitoring for 12 months (NCT03249090). Surveys assessing patients’ satisfaction with the electronic PRO system were administered at 3 months. Descriptive statistics were generated for demographics, survey completion rates, symptom occurrence, and provider PRO alert management approaches. Pairwise relationships between symptom items were evaluated using intra-individual repeated-measures correlation coefficients. ResultsLung cancer patients (n = 118) participating in electronic PROs were older (mean 64.4 vs 61.9 years, p = 0.03), had worse performance status (p = 0.002), more comorbidities (p = 0.02), and less technology experience than patients with other cancers. Of delivered weekly PRO surveys over 12 months, 91% were completed. Nearly all (97%) patients reported concerning (i.e., severe or worsening) symptoms during participation, with 33% of surveys including concerning symptoms. Pain was the most frequent and longest lasting symptom and was associated with reduced activity level. More than half of alerts to clinicians for concerning symptoms led to intervention. The majority (87%) would recommend using electronic PRO monitoring to other lung cancer patients. ConclusionsRemote longitudinal weekly monitoring of patients with lung cancer using validated electronic PRO surveys was feasible in a multicenter, community-based pragmatic study. A high symptom burden specific to lung cancer was detected and clinician outreach in response to alerts was frequent, suggesting electronic PROs may be a beneficial strategy for identifying actionable symptoms and allow opportunities to optimize well-being in this population.

P12.03 A Delphi survey to inform core ‘red flag’ symptoms for an electronic patient reported outcome system in glioblastoma follow up

Abstract BACKGROUND Glioblastoma is a common and aggressive primary malignant brain tumour in adults associated with a poor prognosis and considerable symptom burden. Clinical review and serial neuroimaging remain the primary monitoring tools to assess for disease status. However, the evidence base for the existing surveillance imaging schedule is yet to be established. New models of follow up care are needed to demonstrate better patient outcomes in this patient cohort. There are indications that patient-reported outcome measures (PROMs) can contribute to improved survival and maintaining an optimal quality of life in other oncology populations. MATERIALS AND METHODS There are no standardised PROMs for the priority symptoms in glioblastoma patients, which can be used for evaluation in clinical care as a surrogate marker for disease progression. A broad set of symptoms were therefore initially identified in a targeted literature search and were further refined via Delphi methodology, with the aim to obtain consensus amongst a small expert panel involved in the care of glioblastoma patients. A three round Delphi email survey was conducted. Consensus was defined as 70% agreement. RESULTS Symptom and function constructs were assessed for relevance, relationship to disease and treatment, sensitivity to change, psychometric properties and patient acceptability. Consensus was reached on the red flag symptoms and symptom clusters to monitor, as well as the minimum severity thresholds needed to trigger an alert on an electronic symptom reporting system, which has been developed to allow patient self-reporting of symptoms during treatment. CONCLUSION The red flag symptoms to monitor, along with the symptom severity thresholds, informed an app-based symptom reporting system, which is currently being piloted in a feasibility study exploring triggered imaging using ePROMs. This has the potential to inform future clinical practice through development of patient reported biomarkers.

How Should Oncologists Choose an Electronic Patient-Reported Outcome System for Remote Monitoring of Patients With Cancer?

Electronic patient-reported outcome (ePRO) systems for symptom monitoring in patients with cancer have shown quality of life and survival benefits in controlled trials. They are beginning to be used in routine oncology practice. Many software developers provide software solutions for clinicians, but how should clinicians decide which system to use? We propose a synthesis of the main questions regarding the effectiveness, safety, and functionality of an ePRO system that a clinician should ask software providers to assist in the selection of a software product in order to obtain the best value tools for their patients and their practice.

Successful implementation of an ePRO remote monitoring system in patients receiving chemotherapy in a community oncology practice.

1526 Background: Remote symptom monitoring of patients receiving cancer treatment has been shown to improve patient outcomes in the research setting. However, there is little evidence that this technology can be implemented and scaled in the real world with the same benefits. Methods: Highlands Oncology Group (HOG) is a 19 physician medical oncology group in Northwest Arkansas. Beginning in June 2020, HOG offered patients receiving parenteral cancer therapy enrollment onto Expain: an EMR-integrated, electronic patient-reported outcomes (ePRO) system which enables remote symptom monitoring during systemic cancer therapy. Patients reported distress and symptoms using the NCCN Distress Thermometer and Problem List instrument. The practice prospectively defined patient reporting intervals based on disease and treatment protocol, as well as thresholds for each symptom that would trigger a nursing notification. Following clinical review, nurses initiated interventions including a telephone call, urgent office visit, or referral to an emergency room when necessary. Results: From June 2020 – January 2021, HOG treated 1261 patients with IV chemotherapy. 769 patients were offered enrollment and 569 (73.9%) were successfully enrolled onto the ePRO system. At the time of enrollment 419 (73.6%) of enrolled patients were in an Oncology Care Model (OCM) episode. Common reasons for declined enrollment were: low symptom burden, non-English speaker, and approaching the end of treatment. Of enrolled patients, the most common tumor types were: gastrointestinal (21.8%), breast (17.5%), and thoracic (16.1%). Patients reported using Expain’s mobile app (89.1%) or Interactive Voice Response interface (IVR, 10.1%) with the following frequency: once a month (12%), twice a month (30%), 3 reports a month (35%), and 4 reports or more (23%); Of patients successfully enrolled 52.72% were still reporting after 3 months. The most common reasons specified for opting-out were: death, hospice admission, and completion of the treatment course. 50% of reports exceeded the practice-defined threshold for a nursing notification. The nurses initiated a follow-up call in response to 78.8% of notifications, and of these calls, 21.2% resulted in an urgent office evaluation. The most common problems triggering an office evaluation were: high NCCN Distress Thermometer score (17.1%), fatigue (16.1%), pain (11.5%), nausea (9.4%), and dyspnea (4.5%). Conclusions: ePRO-based remote monitoring of patients receiving parenteral cancer therapy in routine clinical care is feasible. Patient enrollment and retention are high across all tumor types. Symptoms reported by patients were concordant with previous publications, and a small percent (7% of reports) required an acute office visit. It is expected that office intervention will reduce the use of ER and inpatient services.