Electronic Patient-reported Outcomes Research Articles

Comparison of symptom clusters between Black and White patients with cancer within an electronic patient-reported outcome remote symptom monitoring program.

328 Background: Disparities in pain management for Black patients with cancer are well-documented, but less is known about other symptom clusters like gastrointestinal (GI), respiratory, and urinary symptoms. This study assessed racial disparities in electronically reported symptom clusters among Black and White patients with cancer enrolled in a Remote Symptom Monitoring (RSM) program. Methods: Patients with cancer at the University of Alabama at Birmingham (UAB) and the Mitchell Cancer Institute (MCI) reported symptoms weekly using the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAEs). The GI symptom cluster included decreased appetite, nausea, vomiting, constipation, and diarrhea; the respiratory cluster included cough and shortness of breath; the urinary cluster included frequent urinary problems. We assessed the presence of any moderate/severe symptoms or any severe symptoms (triggering a nurse alert) in the clusters. The study evaluated surveys submitted within the first six months after RSM enrollment. Generalized linear mixed effects modeling with random effects adjusting for cancer type, sex, and age were used to calculate the odds of reporting any moderate/severe pain between Black and White patients. Results: Among 1454 patients (31% Black, 69% White), 17,937 surveys were analyzed. The median age for Black patients was 59 (IQR 47-66) and 63 (IQR 54-71) for White patients. Breast cancer was most common in both groups (36% Black, 23% White), followed by gynecological (20% Black, 17% White) and gastrointestinal cancers (19% Black, 18% White). At baseline, both races reported similar proportions of moderate/severe or severe symptom for all clusters (Table). During the first six months in the RSM program, symptom proportions remained similar (Table). These findings were consistent in adjusted analysis for the GI (OR 0.85; 95% CI 0.68-1.07), respiratory (OR 1.18; 95% CI 0.87-1.61), and urinary clusters (OR 0.92; 95% CI 0.61-1.39). Conclusions: Our findings suggest no significant racial disparities in reporting moderate/severe or severe symptoms among Black and White patients with cancer at baseline or within their initial six months in the RSM program across GI, respiratory, and urinary symptom clusters. Survey characteristics. Total Surveys(N=17,937) Baseline Surveys 6 Months Surveys White (n=999) Black(n=455) White(n=11,344) Black(n=5139) Gastrointestinal Symptoms, No. (%) Severe 1376 (8) 121 (12) 59 (13) 783 (7) 413 (8) Moderate/Severe 4701 (26) 300 (30) 130 (29) 2971 (26) 1300 (25) Respiratory Symptoms, No. (%) Severe 438 (2) 28 (3) 29 (6) 241 (2) 140 (3) Moderate/Severe 1612 (9) 90 (9) 62 (14) 996 (8) 464 (9) Urinary Symptoms, No. (%) Severe 333 (2) 31 (3) 13 (3) 184 (2) 105 (2) Moderate/Severe 620 (3) 44 (4) 21 (5) 372 (3) 183 (4)

Patient and care team experiences with an EHR-integrated symptom management program (eSyM) in routine oncology practice.

324 Background: Clinical trials have shown that collecting electronic patient-reported outcomes (ePROs) improves quality of life and survival in cancer patients. To bolster integration of ePROs into routine care, the SIMPRO Research Consortium developed an electronic symptom management (eSyM) program, deployed it at six cancer centers, and conducted a hybrid effectiveness-implementation study. eSyM, an ePRO toolkit integrated into the Epic EHR, enables patients to report and care teams to triage symptoms in real-time. To assess eSyM, we conducted structured qualitative interviews with patients and clinic staff, including doctors, nurses, advanced practice providers, and administrative staff. We sought to understand eSyM from the patient and staff perspectives. Methods: Using an iterative process, we developed semi-structured interview guides to query the experiences and perceptions of patients and staff exposed to eSyM. Questions were informed by the Consolidated Framework for Implementation Research. One year after eSyM was launched, sites identified and referred participants for interviews or focus groups. Participants must have either used eSyM to submit symptoms (patients) or had access to eSyM at their institution (staff). Patients provided written consent; a consent waiver was obtained for staff. Interviews were recorded and transcribed, and a common analytic codebook was developed. Transcripts were dual or triple-coded and underwent thematic analysis to identify key contexts and concepts within and across patient and staff groups. Results: From 9/28/20 to 4/14/23, 50 staff participated in individual interviews and 29 participated in focus groups (79 total). From 9/14/23 to 3/14/24, 14 patient interviews were conducted. Transcripts revealed that staff and patients held similar beliefs regarding eSyM compatibility, communication, and prioritization. 93% (13/14) of patients and 72% (57/79) of staff believed eSyM was easy to use and improved communication. Both cohorts (66% staff, 36% patients) noted that competing demands often needed to be prioritized over responding to symptom concerns. Discordance emerged in the domains of receptivity and technology; patients were more receptive and capable of using eSyM than staff perceived. Both groups believed eSyM was helpful but perceived that deeper engagement from patients and staff was necessary for sustainability. Conclusions: Most interviewees reported that eSyM added value and was easy to navigate. Competing clinical demands, however, frequently deprioritized use of eSyM. Staff tended to underestimate patients’ receptivity to use eSyM and were more likely to cite competing demands as a barrier to their own use of eSyM. Sites looking to adopt eSyM, or similar ePRO programs, will benefit from understanding the facilitators that need to be incorporated and the barriers that need to be surmounted to optimize success. Clinical trial information: NCT03850912 .

Improving the assessment and documentation of systemic cancer therapy–related toxicity in the ambulatory oncology setting.

221 Background: Accurate documentation of systemic cancer therapy toxicity is crucial for patient safety and effective treatment management. However, achieving consistent and comprehensive documentation remains challenging. While the use of electronic patient-reported outcomes (ePROs) is becoming standard in clinical practice, small community-based practices lack the resources to implement this strategy. This project aims to offer alternative methods for implementing patient-reported outcomes in such practices and utilize this information to enhance the documentation of systemic cancer therapy toxicities using the CTCAE (Common Terminology Criteria for Adverse Events). Methods: We conducted a quality improvement project targeting the adequate assessment and documentation of graded toxicity assessments among healthcare providers. Interventions included implementing a patient-reported outcome survey created using the National Cancer Institute PRO-CTCAE form builder, which patients completed while waiting to be seen by the provider. Additionally, we educated providers on how to use the CTCAE grading tool available in Cerner. Rates of documented graded toxicity assessment using the CTCAE system were evaluated among 71 patients aged 18 years or older receiving systemic cancer therapy and attending follow-up appointments at the Seton Cancer Clinic. Data were collected from electronic medical records both before and after the intervention, with 50 patients assessed pre-intervention and 21 patients assessed post-intervention. Results: The implementation of the patient-reported outcome survey and the utilization of the CTCAE grading tool available in Cerner facilitated a more consistent and comprehensive assessment and documentation process. Post-intervention, the rate of documented graded toxicities increased significantly; the percentage of patients with documented graded toxicities increased from 4% pre-intervention to 80% post-intervention. The intervention also improved the workflow efficiency and the accuracy of toxicity assessments in the oncology clinic. Conclusions: These findings highlight the importance of implementing strategies to improve the assessment and documentation of systemic cancer therapy-related toxicity, especially in small community-based practices where resources may be limited. Continued monitoring and periodic data collection will be essential for sustaining these improvements.

Advancing patient-centered cancer care: a systematic review of electronic patient-reported outcome measures.

Electronic Patient-Reported Outcome Measures (ePROMs) have emerged as valuable tools in cancer care, facilitating the comprehensive assessment of patients' physical, psychological, and social well-being. This study synthesizes literature on the utilization of ePROMs in oncology, highlighting the diverse array of measurement instruments and questionnaires employed in cancer patient assessments. By comprehensively analyzing existing research, this study provides insights into the landscape of ePROMs, informs future research directions, and aims to optimize patient-centred oncology care through the strategic integration of ePROMs into clinical practice. A systematic review was conducted by searching peer-reviewed articles published in academic journals without time limitations up to 2024. The search was performed across multiple electronic databases, including PubMed, Scopus, and Web of Science, using predefined search terms related to cancer, measurement instruments, and patient assessment. The selected articles underwent a rigorous quality assessment using the Mixed Methods Appraisal Tool (MMAT). The review of 85 studies revealed a diverse range of measurement instruments and questionnaires utilized in cancer patient assessments. Prominent instruments such as the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and the Patient Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE) were frequently referenced across multiple studies. Additionally, other instruments identified included generic health-related quality of life measures and disease-specific assessments tailored to particular cancer types. The findings indicated the importance of utilizing a variety of measurement tools to comprehensively assess the multifaceted needs and experiences of cancer patients. Our systematic review provides a comprehensive examination of the varied tools and ePROMs employed in cancer care, accentuating the perpetual requirement for development and validation. Prominent instruments like the EORTC QLQ-C30 and PRO-CTCAE are underscored, emphasizing the necessity for a thorough assessment to meet the multifaceted needs of patients. Looking ahead, scholarly endeavours should prioritize the enhancement of existing tools and the creation of novel measures to adeptly address the evolving demands of cancer patients across heterogeneous settings and populations.

User-Centered Design and Usability of Voxe as a Pediatric Electronic Patient-Reported Outcome Measure Platform: Mixed Methods Evaluation Study.

Electronic patient-reported outcome measures (ePROMs) are standardized digital instruments integrated into clinical care to collect subjective data regarding patients' health-related quality of life, functional status, and symptoms. In documenting patient-reported progress, ePROMs can guide treatment decisions and encourage measurement-based care practices. Voxe is a pediatric and user-centered ePROM platform for patients with chronic health conditions. We aimed to describe the user-centered design approach involving feedback from end users and usability testing of Voxe's platform features to support implementation in a pediatric health care setting. Purposive sampling was used to recruit patients aged 8-17 years from 2 chronic illness populations in 2 pediatric hospitals in Canada. Patients' health care team members were also purposively recruited. One-on-one iterative testing sessions were conducted digitally by research team members with participants to obtain feedback on the appearance and functionalities of the Voxe platform prototype. Patients and health care providers (HCPs) completed Voxe-related task-based activities. International Organization for Standardization key performance indicators were tracked during HCP task-based activities. HCPs also completed the System Usability Scale. To test platform usability, the think-aloud technique was used by participants during the completion of structured tasks. After completing all task-based activities, patient participants selected 5 words from the Microsoft Desirability Toolkit to describe their overall impression and experience with the Voxe platform. Qualitative data about likes, dislikes, and ease of use were collected through semistructured interviews. Feedback testing sessions were conducted with patients and HCPs until Voxe was acceptable to participating end users, with no further refinements identified. Quantitative and qualitative data analysis were completed using descriptive statistics and content analysis. A total of 49 patients and 38 HCPs were recruited. Patients were positive about Voxe's child-centered design characteristics and notification settings. HCPs rated Voxe as user-friendly and efficient, with the time to complete tasks decreasing over time. HCPs were satisfied with the Voxe platform functionalities and identified the value of Voxe's system notifications, summarized display of ePROM results, and its capacity to integrate with electronic medical records. Patients' and HCPs' high satisfaction rates with the Voxe prototype highlight the importance of being responsive to user suggestions from the inception of eHealth platform developments to ensure their efficient and effective design. This paper describes the user-centered creation and usability testing of Voxe as an ePROM platform for implementation into clinical care for pediatric patients with chronic health conditions. As a patient-facing platform that can be integrated into electronic medical records, Voxe aligns with measurement-based care practices to foster quality patient-centered approaches to care. End users' positive feedback and evaluation of the platform's user-friendliness and efficiency suggest that Voxe represents a valuable and promising solution to systematically integrate patient-related outcome (PRO) data into complex and dynamic clinical health care settings. RR2-10.1136/bmjopen-2021-053119.

Standardized Usage of Electronic Patient-Reported Outcome Measurements is Time-Efficient and Feasible.

(1) Background: Digitization is of the utmost importance in improving the transfer of medical data. In order to emphasize the need for the greater implementation of digital solutions, we compared analog PROMs (aPROMs) to electronic PROMs (ePROMs) to emphasize the time benefits for clinical everyday life. (2) Methods: This prospective, observational study compared the evaluation of SF-36 in patients between 18 and 80 years old with musculoskeletal pathologies. We performed an age-independent and age-dependent analysis. (3) Results: After the import of aPROMs data, ePROMs took significantly less time (11.97 ± 3.00 min vs. 9.41 ± 3.12 min, p = 0.002, d = 0.797). There were no significant differences associated with age for aPROMs (7.23 ± 2.57 min vs. 8.38 ± 2.71 min, p = 0.061, d = -0.607) or ePROMs (8.72 ± 2.19 min vs. 10.09 ± 3.80 min, p = 0.130, d = -0.436), respectively. (4) Conclusions: This study indicates that ePROMs are a time-feasible method for collecting data to guide patient-personalized treatment approaches.

A Behavior-Based Model to Validate Electronic Systems Designed to Collect Patient-Reported Outcomes: Model Development and Application.

The merits of technology have been adopted in capturing patient-reported outcomes (PROs) by incorporating PROs into electronic systems. Following the development of an electronic system, evaluation of system performance is crucial to ensuring the collection of meaningful data. In contemporary PRO literature, electronic system validation is overlooked, and evidence on validation methods is lacking. This study aims to introduce a generalized concept to guide electronic patient-reported outcome (ePRO) providers in planning for system-specific validation methods. Since electronic systems are essentially products of software engineering endeavors, electronic systems used to collect PRO should be viewed from a computer science perspective with consideration to the health care environment. On this basis, a testing model was blueprinted and applied to a newly developed ePRO system designed for clinical use in pediatric dentistry (electronic Personal Assessment Questionnaire-Paediatric Dentistry) to investigate its thoroughness. A behavior-based model of ePRO system validation was developed based on the principles of user acceptance testing and patient-centered care. The model allows systematic inspection of system specifications and identification of technical errors through simulated positive and negative usage pathways in open and closed environments. The model was able to detect 15 positive errors with 1 unfavorable response when applied to electronic Personal Assessment Questionnaire-Paediatric Dentistry system testing. The application of the behavior-based model to a newly developed ePRO system showed a high ability for technical error detection in a systematic fashion. The proposed model will increase confidence in the validity of ePRO systems as data collection tools in future research and clinical practice.

WP1.15 - Advances in remote electronic monitoring of patient-reported outcomes following discharge after surgery: a systematic review

Abstract Aims Standardising post-discharge care is critical to improving surgical recovery. The COVID-19 pandemic caused major changes to in-person visits and surgical follow-up. An earlier review examined the pre-pandemic capture of electronic patient-reported outcomes (ePRO) post-discharge after surgery. This updated review explores how the pandemic has influenced the use of ePRO systems. Methods Databases (Medline/Embase/PsycINFO/CINAHL/Cochrane) were searched from July 2019-August 2023 using terms for ‘patient-reported outcomes’, ‘electronic’, ‘surgery’ and ‘at home’. Primary research studies collecting ePROs in adult surgical patients post-discharge were included. Data extraction/analyses characterised study design, patient characteristics, ePRO system features, the scope within which ePROs are used post-discharge, what PRO data is collected, adherence to ePRO monitoring, impact on primary/secondary outcomes and the patient and clinician experience of using ePRO systems. Results 12,805 articles were identified, of which 81 were included. Emerging findings indicate an increase in research examining ePRO systems in the post-discharge care of surgical patients, with ∼20 articles/year published post-pandemic, compared to ∼3/year in the 5 years pre-pandemic. Usage of ePROs seems to be most prevalent in orthopaedic and gastrointestinal surgery. Full findings will be available for presentation at the conference. Conclusions Interest in using ePROs to support post-discharge care of surgical patients is growing, in response to service provision changes. Important advances in the capabilities of ePRO systems include real-time clinician feedback and integration with hospital electronic records. The findings of this review will highlight important directions for improving the design of ePRO systems and future research examining the effectiveness of ePRO systems at improving post-surgical recovery.

Chronic kidney disease–associated pruritus: a comparison of instruments and associations with patient-reported outcomes using an electronic patient-reported outcome survey in Europe

ABSTRACT Background The associations between self-reported chronic kidney disease–associated pruritus (CKD-aP) and patient-reported outcomes (PROs) have been reported using various instruments to assess itch. Data collection via multiple CKD-aP instruments allows the evaluation of different domains and measurements of CKD-aP burden and may help tailor data capture for future research or clinical care. Methods An electronic PRO (ePRO) survey was distributed to European hemodialysis (HD) patients enrolled in the Dialysis Outcomes and Practice Patterns Study (DOPPS) in 2021–23. The DOPPS is an international cohort study that aims to investigate practice patterns and outcomes in HD patients. The ePRO survey included multiple CKD-aP instruments: Average Itch and Worst Itching Intensity Numerical Rating Scales (AI-NRS, WI-NRS) and a Kidney Disease Quality of Life (KDQOL)-36 single question. Linear and logistic regression were used to estimate adjusted associations between CKD-aP instruments and various PROs. Results This analysis included 769 patients who completed the WI-NRS from HD facilities in France, Germany, Italy, Spain, Sweden and the UK. The correlation between WI-NRS and the KDQOL-36 itch question was 0.88 overall and 0.46 among patients at least somewhat bothered by itch. Mean WI-NRS scores stratified by response to the KDQOL-36 itch question were 8.1, 6.4, 4.1 and 3.1 for extremely, very much, moderately and somewhat bothered, respectively. Patients with worse WI-NRS scores reported worse sleep quality, greater fatigue, more depressive symptoms, and lower mental and physical quality of life; these associations were similar to those observed for the KDQOL-36 itch question. Conclusion Correlation between CKD-aP instruments was high overall, but moderate among the subgroup of patients bothered by itch; differences can be partially attributed to the recall period for the KDQOL-36 (4 weeks) vs the AI- and WI-NRS (24 h). The consistent associations of these instruments with poor outcomes underscores the importance to identify and effectively treat HD patients suffering from pruritus.

Essential Components of an Electronic Patient-Reported Symptom Monitoring and Management System

Multicomponent electronic patient-reported outcome cancer symptom management systems reduce symptom burden. Whether all components contribute to symptom reduction is unknown. To deconstruct intervention components of the Symptom Care at Home (SCH) system, a digital symptom monitoring and management intervention that has demonstrated efficacy, to determine which component or combination of components results in the lowest symptom burden. This randomized clinical trial included participants who were older than 18 years, had been diagnosed with cancer, had a life expectancy of 3 months or greater, were beginning a chemotherapy course planned for at least 3 cycles, spoke English, and had daily access and ability to use a telephone. Eligible participants were identified from the Huntsman Cancer Institute, University of Utah (Salt Lake City), and from Emory University Winship Cancer Institute, including Grady Memorial Hospital (Atlanta, Georgia), from August 7, 2017, to January 17, 2020. Patients receiving concurrent radiation therapy were excluded. Dates of analysis were from February 1, 2020, to December 22, 2023. Participants reported symptoms daily during a course of chemotherapy and received automated self-management coaching with an activity tracker without (group 1) and with (group 2) visualization, nurse practitioner (NP) follow-up for moderate-to-severe symptoms without (group 3) and with (group 4) decision support, or the complete SCH intervention (group 5). The primary outcome, symptom burden, was assessed as the summed severity of 11 chemotherapy-related symptoms rated on a scale of 1 to 10 (with higher scores indicating greater severity), if present. The 757 participants (mean [SD] age, 59.2 [12.9] years) from 2 cancer centers were primarily female (61.2%). The most common cancer diagnoses were breast (132 [17.4%]), lung (107 [14.1%]), and colorectal (99 [13.1%]) cancers; 369 patients (48.7%) had metastatic disease. The complete SCH intervention including automated self-management coaching and NP follow-up with decision support (group 5) was superior in reducing symptom burden to either of the self-management coaching groups, as shown by the mean group differences in area under the curve (group 1, 1.86 [95% CI, 1.30-2.41] and group 2, 2.38 [95% CI, 1.84-2.92]; both P < .001), and to either of the NP follow-up groups (group 3, 0.57 [95% CI, 0.03-1.11]; P =.04; and group 4, 0.66 [95% CI, 0.14-1.19]; P = .014). Additionally, NP follow-up was superior to self-management coaching (group 1 vs group 3, 1.29 [95% CI, 0.72-1.86]; group 1 vs group 4, 1.20 [95% 12 CI, 0.64-1.76]; group 2 vs group 3, 1.81 [95% CI, 1.25-2.37]; and group 2 vs group 4, 1.72 [95% CI, 1.17-2.26]; all P < .001), but there was no difference between the 2 self-management coaching groups (-0.52 [95% CI, -1.09 to 0.05]; P = .07) or between the 2 NP groups (-0.10 [95% CI, -0.65 to 0.46]; P = .74). In this randomized clinical trial of adult participants undergoing chemotherapy treatment for cancer, the complete intervention, rather than any individual component of the SCH system, achieved the greatest symptom burden reduction. These findings suggest that a multicomponent digital approach to cancer symptom management may offer optimal symptom burden reduction. ClinicalTrials.gov Identifier: NCT02779725.

Asking the Next Generation of Electronic Patient-Reported Outcome Intervention Questions—What Components Are Needed?

Asking the Next Generation of Electronic Patient-Reported Outcome Intervention Questions—What Components Are Needed?

Real-World Implementation of Simulation-Free Radiation Therapy (SFRT-1000): A Propensity Score-Matched Analysis of 1000 Consecutive Palliative Courses Delivered in Routine Care.

The feasibility of simulation-free radiation therapy (SFRT) has been demonstrated but information regarding its routine care impact and scalability is lacking. In this single-institution, retrospective cohort study, all patients receiving palliative radiation therapy at an Australian tertiary cancer center were eligible for consideration of SFRT unless mask immobilization, a stereotactic technique, or a definitive dose was indicated. Coprimary endpoints were SFRT utilization, impact on consultation-to-RT time, and on-couch treatment duration. Timing metrics were compared with a contemporary local cohort that received simulation-based palliative radiation therapy using unadjusted Wilcoxon rank-sum tests and a propensity score-matched regression. Electronic patient-reported outcomes captured 2-week toxicity and pain response. Between April 2018 and February 2024, 2849 palliative radiation courses were delivered, of which 1904 were eligible. Of the 1904 courses, 1000 (52.5% SFRT utilization) received SFRT, including 668 using intensity-modulated radiation therapy/volumetric-modulated arc therapy. A total of 788 individual patients received SFRT and the median age was 71 years (IQR, 61-80) with 59% being male and 42% being Eastern Collaborative Oncology Group 2-4. SFRT utilization increased from 41% to 54% between years 2018-2019 and 2022-2024. SFRT reduced median consultation-to-RT time from 7.0 to 5.1 days (P < .0001) corresponding to an adjusted average treatment effect in the treated of -2.1 days (95% CI, -2.8 to -1.3). SFRT increased median on-couch treatment duration from 17.8 to 20.5 minutes (P < .0001; adjusted average treatment effect in the treated 2.6 minutes, 95% CI, 1.3-3.9). Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events grade 3 acute toxicity was 9% and at 4 weeks after RT, patients with moderate/severe pain at baseline (≥5/10) had a mean pain reduction of 3.5 points (7.1-3.6; P < .0001). Using widely available technologies, the SFRT-1000 cohort demonstrates routine care scalability with patient-centered and workflow benefits. SFRT is an attractive new paradigm implementable in most settings following adaptation to local requirements. Thus, SFRT opens new avenues to potentially improve access to palliative RT, which remains a global area of need.

1489P Factors influencing adherence to electronic patient-reported outcomes in palliative cancer care

1489P Factors influencing adherence to electronic patient-reported outcomes in palliative cancer care

APPROACH e-PROM system: a user-centered development and evaluation of an electronic patient-reported outcomes measurement system for management of coronary artery disease

BackgroundCoronary artery disease (CAD) confers increased risks of premature mortality, non-fatal morbidity, and significant impairment in functional status and health-related quality of life. Routine administration of electronic patient-reported outcome measures (PROMs) and its real time delivery to care providers is known to have the potential to inform routine cardiac care and to improve quality of care and patient outcomes. This study describes a user-centered development and evaluation of the Alberta Provincial Project for Outcomes Assessment (APPROACH) electronic Patient Reported Outcomes Measurement (e-PROM) system. This e-PROM system is an electronic system for the administration of PROMs to patients with CAD and the delivery of the summarized information to their care providers to facilitate patient-physician communication and shared decision-making. This electronic platform was designed to be accessible via web-based and hand-held devices. Heuristic and user acceptance evaluation were conducted with patients and attending care providers.ResultsThe APPROACH e-PROM system was co-developed with patients and care providers, research investigators, informaticians and information technology experts. Five PROMs were selected for inclusion in the online platform after consultations with patient partners, care providers, and PROMs experts: the Seattle Angina Questionnaire, Patient Health Questionnaire, EuroQOL, and Medical Outcomes Study Social Support Survey, and Self-Care of Coronary Heart Disease Inventory. The heuristic evaluation was completed by four design experts who examined the usability of the prototype interfaces. User acceptance testing was completed with 13 patients and 10 cardiologists who evaluated prototype user interfaces of the e-PROM system.ConclusionBoth patients and physicians found the APPROACH e-PROM system to be easy to use, understandable, and acceptable. The APPROACH e-PROM system provides a user-informed electronic platform designed to incorporate PROMs into the delivery of individualized cardiac care for persons with CAD.

Patients with axial spondyloarthritis reported willingness to use remote care and showed high adherence to electronic patient-reported outcome measures: an 18-month observational study

Remote monitoring using electronic patient reported outcomes (ePROs) in axial spondyloarthritis (axSpA) may improve self-management and reduce the need for consultations. However, knowledge regarding patients’ willingness to use remote care and adherence to reporting ePROs is scarce. The objective of this study was to assess axSpA patients’ willingness to use remote care and adherence to reporting of ePROs. The study was part of a three-armed randomized controlled trial testing digital follow-up strategies (The ReMonit study, NCT: 05031767). AxSpA patients in low disease activity were randomized to usual care, remote monitoring, or patient-initiated care. Demographics, clinical data, and patients’ willingness to use remote care were collected at baseline. EPROs were reported either monthly or quarterly by the remote monitoring- and patient-initiated care group over 18 months, respectively. Adherence to reporting was calculated as number of ePROs completed divided by the total number requested. Mixed model logistic regression was utilized to assess factors associated with adherence to reporting of ePROs. In total 242 patients (median age 43 years, 75% males) were included. The majority (96%) reported high willingness to use remote care. Adherence to reporting ePROs remained high over 18 months by remote monitoring and patient-initiated care groups [median (IQR): 88% (77–100) vs. 83% (66–100)]. No patient characteristics were significantly associated with adherence to reporting of ePROs. The high degree of willingness and adherence to reporting ePROs over time indicates that the majority of axSpA patients with low disease activity are motivated to use remote care.

Selecting Immune Checkpoint Inhibitor Side Effects for Real-Time Monitoring in Routine Cancer Care: A Modified Delphi Study.

Electronic patient-reported outcome (ePRO) symptom monitoring may support the safe delivery of immune checkpoint inhibitors (ICI). There is no consensus on which side effects should be monitored in routine care. We aimed to develop a prioritized list of ICI side effects to include in ePRO systems and compare this to existing ICI-specific patient-reported outcome measures (PROMs). We conducted a two-round modified Delphi survey. Participants were patients (or their carers) who had received/were receiving ICI or managing health care professionals (HCPs). Round 1 (R1) side effects were generated from a literature review and existing PROMs. In R1, participants rated the importance of 63 ICI side effects in an ePRO system on a five-point Likert scale. In round 2 (R2), participants ranked the 10 most important side effects from 36 side effects. Content mapping of the prioritized list against existing PROMs was conducted. In R1, 47 patients, nine carers, and 58 HCPs responded. Twenty-eight side effects were rated important (I)/very important (VI) by >75% of participants and included in R2. Ten were rated I/VI by <50% of participants and excluded. Twenty-five were rated I/VI by 50%-75% of participants and discussed at an HCP roundtable to determine inclusion in R2. In R2, 39 patients, 11 carers, and 42 HCPs ranked seizures, shortness of breath, chest pain, diarrhea, and rash as the most important side effects for monitoring. Content mapping showed significant differences between the prioritized list and existing PROMs. We developed a consumer- and clinician-driven prioritized list of 36 ICI side effects to include in future ePRO systems. This process highlights the importance of broad stakeholder engagement in side-effect selection and rigorously identifying clinically important side effects to ensure content validity and clinical utility.

Development and implementation of a digital health intervention (DHI) electronic patient-reported outcome measure (ePROM) platform to monitor patients with cancer.

163 Background: Cancer is heterogeneous diseases associated with a significant burden of symptoms and treatment-related adverse events. Digital Health Interventions (DHIs) emerge as promising tools for active/continuous monitoring of patients (pts). Evidence suggests that DHIs may enhance healthcare delivery and improve clinical outcomes by facilitating symptom detection and enabling more effective real-time informed decisions. We aim to develop and implement an electronic Patient-reported Outcome Measure (ePROM) platform to monitor pts undergoing cancer treatment. Methods: We developed ThummiOnco, a DHI ePROM platform designed for monitoring of pts during cancer treatment. It allows pts to report their symptoms (reported and graded according to the CTCAE), quality-of-life (QoL) (EORTC EQ-5D questionnaire), emotional state, treatment adherence (Morisky-Green questionnaire), Emergency Room (ER) visits and hospitalizations through a mobile application. Upon registration, pts consent to share their data with their medical team and provide essential demographic information such as age, sex, cancer type, and treatment regimen. A medical algorithm analyzes the collected data to generate instant personalized recommendations and guidance, including indicating the need of seeking emergency care in the case of serious high-grade or worrisome complaints. Patients also have the option to engage in real-time conversations with the medical team through an online chat feature. Treating physicians and the medical team can continuously access pts data real-time, through an online dashboard, enabling them to visualize information and statistics, address symptom alerts, and make informed management decisions. ThummiOnco is available at no cost to pts at htt ps://thummi.global . Results: Between August 2021 and March 2024, ThummiOnco monitored 925 pts across 7 institutions in Brazil, encompassing both private and public health systems. The majority of pts (72%) were female, with 28% being male. The most frequently monitored cancer types were Breast Cancer (39%), Lung Cancer (7%) and Colon Cancer (6%). During this period, a total of 71.373 interactions were recorded, including 36.175 (51%) chat messages, 21.644 (30%) symptom reports, 10.597 (15%) emotional state reflections, 2.819 (4%) QoL assessments, and 138 (0.2%) ER registries. A total of 23 different symptoms were reported, with the most frequent being: fatigue (16%), joint pain (8%), and nausea (7%). 13.187 (61%) grade 1, 6.545 (30%) grade 2, and 1.912 (9%) grade 3 symptoms were registered. In total, the medical algorithm generated 1.921 recommendations for seeking emergency care. Conclusions: ThummiOnco's capacity to detect a wide range of symptoms and enable real-time informed decisions underscores its potential to enhance patient outcomes and healthcare service delivery.

Investigation of screening questions to identify insomnia in cancer patients

The high prevalence of insomnia in cancer patients leads to a significant reduction in the quality of life of those affected. A detailed record of symptoms therefore plays an essential role for further course of treatment. Which screening instruments enable identification of cancer patients with insomnia is the subject of this single-arm nonrandomized study. During the data collection period, cancer patients meeting the following criteria: self-reported tiredness and/or trouble falling or staying asleep or sleeping too much in an electronic patient-reported outcome measurement were enrolled. For further analysis, focus was placed on the Patient Health Questionnaire Depression Scale (PHQ-8), the Minimal Documentation System (MIDOS2) and the Insomnia Severity Index (ISI). Frequency, correlation, and variance analyses were conducted to identify likely predictors of insomnia. Our findings indicate a closer correlation between the screening question pertaining to sleep disorders and the ISI, compared to the question on tiredness and the ISI. The initial recording of sleep-related parameters plays an essential role for cancer patients in order to identify and treat modifiable factors as promptly as possible. For an initial assessment, we recommend asking about trouble falling or staying asleep or sleeping too much.

Evaluating the Population-Based Usage and Benefit of Digitally Collected Patient-Reported Outcomes and Experiences in Patients With Chronic Diseases: The PROMchronic Study Protocol.

Chronic diseases are associated with a high disease burden. Under- and overprovision of care as well as quality variation between health care providers persists, while current quality indicators rarely capture the patients' perspective. Capturing patient-reported outcome measures (PROMs) as well as patient-reported experience measures (PREMs) is becoming more and more important to identify gaps in care provision, prioritize services most valuable to patients, and aid patients' self-management. This study aims to measure the potential benefits and effectiveness of using electronic patient-reported outcome measures (ePROMs) and electronic patient-reported experience measures in a structured and population-based manner to enhance health care for chronic disease patients in Germany. This prospective cohort study aims to evaluate the potential benefits of PROM usage in patients with chronic diseases. We evaluate whether (1) digitally collected PROMs and PREMs can be used for health system performance assessment by generating a representative response of chronically diseased individuals with asthma, chronic obstructive pulmonary disease, diabetes, and coronary artery disease across Germany, and (2) based on the PROMs and PREMs, low-value care can be identified. As patient-reported outcomes (PROs) are rarely presented back to patients, (3) this study also examines patients' reactions to their PROM scores in the form of digital PRO feedback. For these purposes, randomly selected patients from a nationwide German insurer are digitally surveyed with generic and disease-specific PROMs and PREMs, as well as additional questions on their health-related behavior, 4 times over 1 year. Individual PRO feedback is presented back to patients longitudinally and compared to a peer group after each survey period. Patient-reported data is linked with health insurance data. Response rates, changes in health and experience outcomes over time, self-reported changes in health behavior, and health care system usage will be analyzed. The PROMchronic study explores the usage of PROMs in patients with chronic diseases. Data collection began in October 2023, after the initial invitation letter. All the 200,000 potential patients have been invited to participate in the study. Data have not yet been analyzed. Publication of the interim results is planned for the autumn of 2024, and the results are planned to be published in 2025. We aim to fill the research gap on the population-based usage of PROMs and PREMs in patients with chronic diseases and add to the current understanding of PROM data-sharing with patients. The study's results can thereby inform whether a health care system-wide approach to collecting PROMs and PREMs can be used to identify low-value care, assess quality variation within and across chronic conditions, and determine whether PRO feedback is helpful and associated with any changes in patients' health behaviors. German Clinical Trials Register DRKS00031656; https://drks.de/search/en/trial/DRKS00031656. DERR1-10.2196/56487.

FASTOCH: Feasibility of Electronic Patient-Reported Outcomes in Older Patients With Cancer-A Multicenter Prospective Study.

Multiple studies have demonstrated that electronic patient-reported outcomes (ePROs) improve overall survival and quality of life in cancer care. However, there are no specific prospective data on remote ePRO monitoring in the older population, although they represent a significant proportion of patients with cancer. From February 2021 to April 2022, patients age 75 years and older under active anticancer treatment were consecutively recruited in six institutions. Remote ePRO feasibility was determined in intention-to-test (ITT) on the basis of the number of active users in the overall population. Primary failure applied to patients who had no Internet access or declined to test ePROs, while the other patients were assigned to the ITT population. Feasibility was also determined per-protocol on the basis of the number of active patients in the ITT population. Of the 473 patients included, primary failure applied to 288 patients (233 of whom had no Internet access). Among the 185 patients in ITT, 122 used ePROs, leading to a 26% feasibility in ITT and a 66% feasibility per protocol. In a multivariate analysis, the intent to test population was from a higher socioprofessional category (P = .009) and felt in better general condition in the Geriatric 8-score evaluation (P = .002). Active patients significantly differed from the inactive on their self-assessment of a better general condition (P < .001) only. Our multicenter study showed a limited feasibility rate (26%) of remote ePROs monitoring for older patients with cancer, mainly because of technology barriers. Yet, among the patients who did have Internet access, most of them indeed used ePROs (66%). Given the expected benefit of ePROs, the technology barriers therefore need to be lifted to improve cancer care in older patients.