Electronic Patient-reported Outcome Measures Research Articles

Exploring the value of routinely collected data on EQ-5D-5L and other electronic patient-reported outcome measures as prognostic factors in adults with advanced non-small cell lung cancer receiving immunotherapy

ObjectiveInvestigate whether routinely collected electronic patient-reported outcome measures (ePROMs) add prognostic value to clinical and tumour characteristics for adults with advanced non-small cell lung cancer (NSCLC) receiving immunotherapy.Methods and analysisWe...

A clinical audit of patient outcomes in real-world acupuncture practice.

Clinical auditing represents a valuable and cost-effective method for the collection of patient outcomes and is increasingly being used to inform clinical guidelines. The aim of this clinical audit was to assess patient outcomes across a small subset of acupuncture practitioners and private practices in the United Kingdom. The Measure Yourself Medical Outcomes Profile (MYMOP) questionnaire and the Patient Global Impression of Change (PGIC) scale were used as outcome measures. Additional questions assessed adverse events and patient experience with care. Clinical data were collected utilising an electronic patient-reported outcome measures (ePROMs) system. Baseline data were collected for a total of 233 health complaints (from 232 patients), of which 45.9% were musculoskeletal and 26.2% were psychological. Follow-up outcomes data were available for 144 health complaints (61.8% completion rate). For PGIC responses, >90% of health complaints were reported as at least 'minimally improved'. This was reduced to >51% when controlling for missing data. There was a gradual improvement in both mean MYMOP scores (24.5%-43.0%) and PGIC responses of 'very much improved' (12.3%-56.3%) over a 6-month period. A clinically significant improvement (>1 point change, p ⩽ 0.001) was seen in mean MYMOP scores compared to baseline from 4 to 8 weeks and symptom 1 MYMOP scores from 1 to 4 weeks. A moderately strong, negative correlation was seen between outcome measures (r = -0.507, p < 0.001). The majority of patients reported clinically meaningful improvements for their main health complaints/symptoms, which appeared to be sustained in the medium to long-term.

OA41 Exploring patterns of patient engagement with electronic patient reported outcome measures in inflammatory arthritis using latent class growth modelling

Abstract Background/Aims Routine collection of electronic patient reported outcome measures (ePROMs) can facilitate dynamic disease activity monitoring in patients with inflammatory arthritis (IA). In a real-world cohort of patients with IA, we describe patient characteristics associated with ever engaging with ePROMs, evaluate whether there are distinct groups of patients with similar engagement trajectories over time and identify patient characteristics associated with these groups. Methods We conducted a prospective observational study based on routinely collected data from a remote monitoring platform (RMP) at Guy’s and St Thomas’ NHS Foundation Trust in London, UK, between 18 December 2018 and 15 August 2022. Patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA) were sent text message requests to complete 4-weekly disease specific PROMs. A patient was defined as an engager if they completed at least one PROM episode during the study period of 68 weeks. Logistic regression (LR) was used to identify associations between baseline characteristics and any PROM engagement. Latent class growth modelling (LCGM) was used to determine PROM engagement trajectories, with multinomial LR exploring baseline characteristic associations with latent trajectory class membership. Results Of 1,203 patients on RMP in the study period, 1,129 met the inclusion criteria, of which 91.5% (95% CI 89.7% - 93.0%) completed at least one PROM. Mean age was 49 years and 64% were female. 60% had RA, 24.4% had PsA and 15.7% had AxSpA. Overall engagement was relatively high throughout, with continued engagement &amp;gt;60% over the remaining 68 weeks. Older patients (adj OR 0.98, 95% CI 0.96 - 0.99), those from more deprived areas (adj OR 0.80, 95% CI 0.68 - 0.96) and those who attended &amp;lt;80% of their outpatient visits in the preceding 3 years (adj OR 0.48, 95% CI 0.26 - 0.89) were less likely to complete a PROM. Four latent trajectory classes were identified: consistent engagers (38.1%), high-variable engagers (24.3%), low-variable engagers (19.5%) and never &amp; dis-engagers (18.1%), with a mean (SD) overall response rate per class of 96.5% (7.1), 74.1% (12.1), 35.6% (13.8) and 7.5% (12.0) respectively. Compared to the consistent engager class, the two variable engager classes were significantly more likely to be younger at baseline, whilst the never &amp; dis-engager class was more likely to be from a deprived area. Having an IA type of PsA and previous clinic non-attendance was associated with membership of the three lower engaging classes. Conclusion We have described key patient characteristics that influence engagement with ePROMs in a real-world cohort of patients with IA, and patterns of engagement over time. Overall engagement was very high with &amp;gt;90% of patients enrolled engaging with PROM completion. There is still scepticism among clinicians about remote monitoring’s ability to work, and our findings should be reassuring: patients do engage with ePROMs over time. Disclosure N. Arumalla: None. Z. Yang: None. S. Norton: None. M. Crooks: None. A. Khan: None. R. Fitzgerald: None. R. Gilligan: None. E. Lindberg: None. T. Tabibi: None. Y.L. Man: None. S. Subesinghe: None. J.B. Galloway: Consultancies; Abbvie, Biovitrum, BMS, Celgene, Chugai, Galapagos, Gilead, Janssen, Lilly, Pfizer, Novartis, Roche, Sanofi, Sobi, UCB. Honoraria; Abbvie, Biovitrum, BMS, Celgene, Chugai, Galapagos, Gilead, Janssen, Lilly, Pfizer, Novartis, Roche, Sanofi, Sobi, UCB. T. Garrood: Shareholder/stock ownership; Serac healthcare. Honoraria; Abbvie, UCB. Grants/research support; Versus Arthritis, Pfizer, Gilead, Guy's and St Thomas' Charity, NHSX. Other; Fresnius-Kabi.

E041 Feasibility and acceptability of electronic patient reported outcome measures in the routine care of people with inflammatory arthritis: Haywood Arthritis Portal study

Abstract Background/Aims Electronic patient-reported outcome measures (ePROMs) assessing disease activity, function, pain, and quality of life can facilitate innovative inflammatory arthritis (IA) care, such as automating patient-initiated follow-up. This mixed-methods study evaluated whether their use is feasible and acceptable in routine care of people with inflammatory arthritis in an NHS setting. Methods The Haywood Arthritis Portal (HAP) is an NHS co-designed online patient platform, enabling people with IA under the Midlands Partnership University NHS Foundation Trust (MPFT) to enter ePROMs using any internet-enabled device. People with IA attending recruiting clinics from January-October 2023 received text message/letter invitations to complete HAP pre-appointment. Non-completers could complete HAP on tablets at the clinic. Consenters also completed a survey assessing ePROMs acceptability and HAP usability. Responses were summarised as proportions, stratified by age, gender, IA type, and home/clinic-completion status. Purposively sampled survey-completers participated in semi-structured interviews, providing deeper understanding of ePROMs/HAP feasibility/acceptability. This abstract presents data from an interim analysis of consenting patients with available survey and case report form data. Results Survey Population: 210 patients were included: 107 (51%) home-completers; 98 (47%) clinic-completers; 5 (2%) HAP non-completers; 70% female; mean age 60 years. Most had RA (70%), followed by Axial SpA (15%), undifferentiated IA (8%), and PsA/other SpA (7%). ePROMs Acceptability: 86% rated ePROMs acceptable/completely acceptable; 82% felt their completion required little/no effort; 87% agreed/strongly agreed their answers were likely to help their care. Fewer people aged &amp;gt;70 years rated ePROMs acceptable/completely acceptable (70%) compared with younger age groups (ranging 82%-100%); the same was the case for clinic-completers (79%) vs. home-completers (93%). Perceived ePROMs Use by Clinicians: 58% agreed/strongly agreed their healthcare professional had looked at their ePROMs. This was proportionally more in people aged 18-40 (79%) than older age groups (ranging 48%-58%), in axial SpA (70%) than other IA types (ranging 50%-54%), and in males (67%) vs. females (53%). HAP Usability: 78% agreed/strongly agreed HAP was easy to use. This was higher in those aged 18-40 years (93%) than those aged &amp;gt;70 years (70%), and in home-completers (89%) than clinic-completers (67%), Interviews: involved 11 participants and findings supported quantitative results, in that participants generally considered ePROMs acceptable, HAP easy to use, yet they were uncertain if their entries were used by their healthcare professional. In addition, participants were reassured that HAP was NHS-developed and secure, and expressed interest in completing ePROMs more regularly. Conclusion Using ePROMs in routine NHS care is acceptable to most people with IA, particularly younger people and those able to enter them on their own devices. The next step in this study is to consider healthcare professionals’ perspectives on ePROMs, including how they can be best integrated into consultations to ensure patients feel their entries are considered. Disclosure N. Cox: None. C. Kettle: None. H. Wang: None. S. Dutta: None. J. Packham: None. J. Galloway: None. J. Hill: None. S. Muller: None. S. Hider: None. Z. Paskins: None. L. Bullock: None. I.C. Scott: None.

Validation of Biomarkers and Patient-Reported Outcome Measures to Improve the Diagnosis and Treatment of Eustachian Tube Dysfunction

Patients who suffer from Eustachian tube dysfunction (ETD) experience a significant decline in quality of life. To enhance patient outcomes, it is crucial to establish an accurate diagnosis, assess treatment effectiveness, and evaluate the severity of the condition. Substantial progress has recently been made in identifying biomarkers (BMs) and developing ETD clinical outcome assessments (COAs). This study examines the current state of BMs and COAs in ETD, including the methods evaluated historically and their potential clinical applications. The research in this area emphasizes the importance of using objective measures, such as middle ear pressure (MEP) and patient-reported outcome measures (PROMs), for diagnosing and evaluating ETD. Further, I discuss how electronic PROMs (ePROMs) and other digital health technologies can guide the development of innovative PROMs that ETD. Despite significant advances in COAs for ETD, much work remains to validate and improve them before their implementation in clinical practice. There has been less focus on vertigo as a symptom in recent assessments of ETD, suggesting that further examination of this aspect is needed. By validating BMs and COAs for ETD, we could enhance long-term patient outcomes and quality of life through improved diagnostic accuracy and evaluation of treatment efficacy.

147 Patient Reported Experience of Using Electronic Patient Reported Outcome Measures (ePROMs) During and After Lung Radiotherapy. A Pilot Study

147 Patient Reported Experience of Using Electronic Patient Reported Outcome Measures (ePROMs) During and After Lung Radiotherapy. A Pilot Study

146 Using Electronic Patient-Reported Outcome Measures (ePROMs) to Monitor Symptoms and Quality of Life for Patients with Lung Cancer Undergoing Radiotherapy. A Pilot Study

146 Using Electronic Patient-Reported Outcome Measures (ePROMs) to Monitor Symptoms and Quality of Life for Patients with Lung Cancer Undergoing Radiotherapy. A Pilot Study

Patient-Reported Outcome and Experience Measures in Advanced Nursing Practice: What Are Key Considerations for Implementation and Optimized Use?

ObjectiveTo discuss the opportunities and challenges of implementing patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) within advanced practice nursing services in cancer care. MethodsThis discussion paper has been informed by an environmental scan of evidence from systematic reviews and primary studies evaluating the use and implementation of PROMs and PREMs. Literature from the contexts of cancer and chronic disease, including nursing and multidisciplinary supportive care literature, has been included. ResultsAdvanced practice nurses are well-positioned to evaluate and respond to PROMs and PREMs data; several studies have highlighted improved patient outcomes concerning quality of life, symptom distress, and functional status within nurse-led services. Nevertheless, the implementation of PROMs and PREMs in cancer care and nurse-led services is variable. Previous studies have highlighted implementation challenges, which can hinder comparability and generalizability of PROMs and PREMs instruments. Advanced practice nurses should consider these challenges, including ways to use standardized PROM instruments. Electronic PROMs, while efficient, may exclude individuals at risk of inequity. Complex, lengthy, and frequent administration of PROMs may also overburden people living with or after cancer, with people affected by cancer expressing preference for flexible use in some studies. Therefore, the involvement of people affected by cancer in planning for PROMs/PREMs implementation may overcome this challenge. Finally, organizational considerations in implementation should address financial investments, including initial costs for technology and training and consideration of the operationalization of PROMs within existing infrastructure for the seamless utilization of PROMs data. ConclusionDespite the potential of advanced practice nursing services to enhance patient-reported outcomes and experiences, variability in the implementation of PROMs and PREMs poses challenges. Use of validated measures, electronic or paper-based instruments, and the preferences of people affected by cancer for the use of PROMs and PREMs must be carefully considered in consultation with end users for successful implementation. Implications for PracticeIn planning for the implementation of PROMs and PREMs within nurse-led services, implementation risks may be mitigated through establishing clear guidelines for their use, investment in the development of the required infrastructure, user education, and rigorous implementation processes, including patient involvement in PROMs/PREMs selection.

Benchmark findings from a veteran electronic patient-reported outcomes evaluation from a chronic pain management telehealth program

BackgroundChronic pain is a leading cause of disability and negatively impacts biological/physical, psychological, and social aspects of life resulting in significant pain interference or disability. This project was part of a longitudinal mixed-methods implementation evaluation of the TelePain-Empower Veterans Program (EVP), a non-pharmacological chronic pain intervention. The purpose of this quality management project was to examine electronic patient-reported outcome measures (ePROs) including primary pain-related (intensity, interference, catastrophizing, kinesiophobia) and secondary outcomes (physical, psychological, acceptance, social) to determine TelePain-EVP effectiveness. Secondary purpose was to examine dosing effects to better understand potential dose relationships between EVP use and ePROs.MethodsStandardized ePRO measures were examined at week 1 (baseline), week 10 (post-EVP), and week 26 (follow-up). Qualtrics, a cloud-based platform was used to collect ePRO data at each time point. Veterans that completed at-least one survey at any specified time point were categorized as responders (n = 221). Linear-mixed models (LMMs) were fit to assess changes for each primary and secondary ePRO.ResultsParticipants ranged from 24 to 81 years old; veterans were typically male (65.16%), black or African American (76.47%), married or partnered (41.63%), attended at-least some college or vocational school (67.87%), and reported low back as their primary pain location (29.41%). There was a significant decrease in pain catastrophizing from baseline to post-TelePain-EVP (p < .001). However, pain catastrophizing improvement from baseline was not present at week 26 (p = .116). Pain interference also decreased from baseline to post-treatment (p = .05), but this improvement did not exceed the adjusted significance threshold. Additional pre-post improvements were also observed for certain secondary ePROs: psychological (anxiety, depression), acceptance (activities engagement). Only the activities engagement effect remained 26 weeks from baseline. Mixed results were observed for EVP dose across primary and secondary outcomes.ConclusionsEvidence from this evaluation indicate that TelePain-EVP has positive outcomes for certain pain (catastrophizing), psychological (anxiety, depression), and acceptance (activities engagement) for veterans with chronic pain. More TelePain related studies and enterprise-wide evaluations are needed along with comparative and cost effectiveness methods to determine patient benefits and the economic value gained of treatment options such as TelePain-EVP.

Implementation of the e-IPOS in Home Palliative Cancer Care: A Quasiexperimental Pilot Study.

Electronic patient-reported outcome measures (e-PROMs) offer advantages in palliative cancer care, including rapid completion, improved data quality and direct storage, improving clinical decision-making. The electronic Integrated Palliative Care Outcome Scale (e-IPOS) in this context enables thorough self-assessment by patients, enhancing symptom management and self-reflection of their current situation. To evaluate the feasibility of implementing the e-IPOS in home palliative cancer care. The primary outcomes included the enrollment consent rate, study retention rate, e-IPOS completion rate and response completeness, and the number of clinical assessments and interventions performed during home visits. The secondary outcomes were the number of unscheduled visits and patients' perceived quality of life. A two-group quasiexperimental clinical pilot study. The control group received standard palliative care, the intervention group received standard care along with weekly e-IPOS completion during home visits. Both groups were enrolled for 4weeks. Adults with advanced cancer from the home palliative care unit of the Istituto Nazionale dei Tumori of Milan. Twenty-three patients were enrolled (74.19%), and 20 completed the study (drop-out: 13.04%). 82.5% of the expected e-IPOS responses were received, of which 96.9% were fully complete. In the intervention group, the Wilcoxon test showed an increase in identified needs and documented interventions (P < .05) and a decrease in unscheduled visits (P < .05). It is feasible to recruit people via home palliative care for an e-IPOS implementation study. Future fully powered studies should investigate the feasibility and assess patients' perceptions of its use to better understand its clinical benefits.

How to Monitor Disease Activity of Axial Spondyloarthritis in Clinical Practice.

Treatment guided by periodic and quantitative data assessment results in better outcomes compared to using clinical gestalt. While validated generic as well as specific disease activity measures for axial spondyloarthritis (axSpA) are available, there is vast scope to improve their actual utilization in routine clinical practice. In this review, we discuss available disease activity measures for axSpA, describe results from the survey conducted among general rheumatologists as well as Spondyloarthritis Research and Treatment Network (SPARTAN) members about disease activity measurement in daily practice, and discuss ways to improve axSpA disease activity using technological advances. We also discuss the definitions of active disease and target for the treatment of axSpA. The 2019 American College of Rheumatology (ACR)/Spondylitis Association of America (SAA)/Spondyloarthritis Research and Treatment Network (SPARTAN) axSpA treatment guidelines conditionally recommend the regular monitoring of disease activity using a validated measure such as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) or Ankylosing Spondylitis Disease Severity Index (ASDAS). Assessment of Spondyloarthritis International Society (ASAS)-European Alliance of Associations for Rheumatology (EULAR) guidelines recommend ASDAS as the most appropriate instrument for the assessment of disease activity, preferably calculated using C-reactive protein (CRP). ASAS has selected a core set of variables which were updated recently and have been endorsed by the Outcome Measures in Rheumatology Clinical Trials (OMERACT) group in order to bring homogeneity in assessment of axSpA. In a recent study, Patient-Reported Outcomes Measurement Information System (PROMIS®) measures were able to discriminate inactive, moderate, and high-very high ASDAS activity groups. A newly developed semi-objective index P4 (pain, physical function, patient global, and physician global) correlates well with BASDAI and ASDAS in axSpA and can also be used for other rheumatic diseases in busy clinical practices. Regular disease activity monitoring is critical for long-term management of axSpA and shared decision-making. The integration of electronic health records and smart devices provides a great opportunity to capture patient-reported data. Automated capture of electronic patient-reported outcome measures (ePROMs) is a highly efficient way and results in consistent regular monitoring and may improve the long-term outcomes. While currently used measures focus only on musculoskeletal symptoms of axSpA, a composite disease activity measure that can also incorporate extra-articular manifestations may provide a better assessment of disease activity.

Predictive Criterion Validity of the Parsley Symptom Index Against the Patient-Reported Outcomes Measurement Information System-10 in a Chronic Disease Cohort: Retrospective Cohort Study.

Approximately 60% of US adults live with chronic disease, imposing a significant burden on patients and the health care system. With the rise of telehealth, patient-reported outcomes measures (PROMs) have emerged as pivotal tools for managing chronic disease. While numerous PROMs exist, few have been designed explicitly for telehealth settings. The Parsley Symptom Index (PSI) is an electronic patient-reported outcome measure (ePROM) developed specifically for telehealth environments. Our aim is to determine whether the PSI predicts changes in the established Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) Global Health, a 10-question short form. We conducted a retrospective cohort study using data from 367 unique patients, amassing 1170 observations between August 30, 2017, and January 30, 2023. Patients completed the PSI and the PROMIS-10 multiple times throughout the study period. Using univariate regression models, we assess the predictive criterion validity of the PSI against PROMIS-10 scores. This study revealed significant relationships between the PSI and PROMIS-10 physical and mental health scores through comprehensive univariate analyses, thus establishing support for the criterion validity of the PSI. These analyses highlighted the PSI's potential as an insightful tool for understanding and predicting both mental and physical health dimensions. Our findings emphasize the importance of the PSI in capturing the nuanced interactions between symptomatology and health outcomes. These insights reinforce the value of the PSI in clinical contexts and support its potential as a versatile tool in both research and practice.

Remote Symptom Monitoring with Clinical Alerts Following Mastectomy: Do Early Symptoms Predict 30-Day Surgical Complications.

Electronic patient-reported outcome measures (ePROMs) for real-time remote symptom monitoring facilitate early recognition of postoperative complications. We sought to determine whether remote, electronic, patient-reported symptom-monitoring with Recovery Tracker predicts 30-day readmission or reoperation in outpatient mastectomy patients. We conducted a retrospective review of breast cancer patients who underwent outpatient (< 24-h stay) mastectomy with or without reconstruction from April 2017 to January 2022 and who received the Recovery Tracker on Days 1-10 postoperatively. Of 5,130 patients, 3,888 met the inclusion criteria (2,880 mastectomy with immediate reconstruction and 1,008 mastectomy only). We focused on symptoms concerning for surgical complications and assessed if symptoms reaching prespecified alert levels-prompting a nursing call-predicted risk of 30-day readmission or reoperation. Daily Recovery Tracker response rates ranged from 45% to 70%. Overall, 1,461 of 3,888 patients (38%) triggered at least one alert. Most red (urgent) alerts were triggered by pain and fever; most yellow (less urgent) alerts were triggered by wound redness and pain severity. The 30-day readmission and reoperation rates were low at 3.8% and 2.4%, respectively. There was no statistically significant association between symptom alerts and 30-day reoperation or readmission, and a clinically relevant increase in risk can be excluded (odds ratio 1.08; 95% confidence interval 0.8-1.46; p = 0.6). Breast cancer patients undergoing mastectomy with or without reconstruction in the ambulatory setting have a low burden of concerning symptoms, even in the first few days after surgery. Patients can be reassured that symptoms that do present resolve quickly thereafter.

Seizing the moment: The time for harnessing electronic patient-reported outcome measures for enhanced and sustainable metastatic breast cancer care is now

The sustainability of healthcare systems is under pressure. Unlike care for many other chronic diseases, cancer care has yet to empower patients in effectively self-managing both the medical and emotional consequences of their condition, including adapting to changes in lifestyle and work, which is essential to achieve optimal health and recovery. Although proposed as a potential solution for sustainable healthcare and support for optimal health and recovery already decades ago, practical implementation of digital care lags behind.We believe electronic patient reported outcome measures (ePROMs) could play an important role in creating sustainable healthcare, both to guide complex treatment pathways and to empower survivors to self-manage consequences of diagnosis and treatment. That is, ePROMs can be used for screening and monitoring of symptoms, but also for treatment decision-making and to facilitate communication about quality of life. We therefore see opportunities for improvements in quality of care, quality of life, and survival of cancer patients, as well as research opportunities, as ePROMs collection can lead to better understanding of care needs. The ‘10 Actions for Change report’ of the Advanced Breast Cancer Global Alliance stresses a critical need for improvement of care for metastatic breast cancer (MBC) patients. We therefore in this paper focus on MBC care and research.

IMPLEMENTING SYSTEMATIC PATIENT-REPORTED MEASURES FOR CHRONIC CONDITIONS THROUGH THE NAVETA VALUE-BASED TELEMEDICINE INITIATIVE: RESULTS OF AN OBSERVATIONAL, RETROSPECTIVE AND MULTICENTER STUDY.

Patient-reported outcome and experience measures can play a critical role in providing patient-centered and value-based healthcare to a growing population of chronically ill patients. Value-based telemedicine platforms such as the Naveta initiative may facilitate the effective integration of these tools into healthcare systems. This study aims to evaluate the response rate to electronic patient-reported outcome measures (ePROMs) and electronic patient-reported experience measures (ePREMs) among patients participating in the Naveta telemedicine initiative, its correlations with sociodemographic and clinical characteristics, and the evolution of the rates over time. Between January 1, 2021, and June 30, 2023, a total of 53,364 ePREMs and ePROMs for 20 chronic conditions were administered through the Naveta-Phemium platform. Descriptive statistics were used to summarize continuous and categorical variables. Differences in response rates within each sociodemographic variable were analyzed using logistic regression models, with significance assessed via the chi-square and post-hoc Tukey tests. Two-way ANOVA was used to examine the interaction between time interval and disease type on response rate evolution. A total of 3,372 patients with severe chronic diseases from 64 public hospitals in Spain participated in the Naveta health questionnaire project. The overall response rate to ePROMs and ePREMs during the first 2.5 years of the Naveta initiative was 46.12%, with a baseline rate of 53.33%. Several sociodemographic factors correlated with lower response rates, including male gender, older age, lower education level, frequent alcohol use, being a student, and not being physically active. There were also significant variations in response rates among different types of chronic conditions, with the highest rates for respiratory (71.45%), oncologic (62.70%), digestive (62.40%), and rheumatic diseases (57.82%), and the lowest for HIV+ patients (32.93%). During the first 6 months of follow-up, response rates decreased in all disease types, except for the oncology group, which increased up to 100%. Subsequently, the overall response rate approached baseline levels. Recognizing the influence of sociodemographic factors on response rates is critical to identifying barriers to participation in telemonitoring programs and ensuring inclusiveness in patient-centered healthcare practices. The observed decline in response rates at follow-up may be due to survey fatigue, highlighting the need for strategies to mitigate this effect. In addition, the variation in response rates across chronic conditions emphasizes the importance of tailoring telemonitoring approaches to specific patient populations.

Exploring patient perspectives on electronic patient-reported outcome measures in home-based cancer palliative care: A qualitative study.

Electronic patient-reported outcomes (ePROMs) enhance symptom management and patients' engagement in palliative cancer care. However, integrating them into this setting brings challenges, including patients' familiarity with technological devices and declining health status. Prioritizing the patient's acceptability and feasibility is crucial for their adoption. However, more knowledge is needed about patients' perspectives on the adoption of ePROMs in the community, especially for home-based palliative care. Explore patient viewpoints on utilizing ePROMs for symptom reporting in home-based oncology palliative care. A qualitative interpretative approach was used to evaluate patients' points of view on using ePROMs in this specific care setting. Semistructured interviews were carried out. Data were analyzed using a reflexive thematic analysis. A total of 25 patients receiving oncological home palliative care from the advanced palliative care unit of the Fondazione IRCCS Istituto Nazionale dei Tumori in Milan, Italy, were invited to participate. Twenty interviews were conducted, as five patients declined due to deteriorating health. Four themes were identified: (1) strategic value of ePROMs and subjective appreciation; (2) enhancing patient centeredness through ePROMs; (3) exploring and addressing concerns about the use of ePROMs and (4) intersecting factors influencing the efficacy of ePROMs. Despite initial reticence, home palliative care patients consider ePROMs as potentially valuable allies monitoring symptoms, enhancing their quality of life, and amplifying their voices on less explored aspects of care. Continuous dialog between healthcare professionals and patients is crucial for addressing patient skepticism about ePROMs and their impact on the human aspect of care.

Involving Patients and Clinicians in the Design of Wireframes for Cancer Medicines Electronic Patient Reported Outcome Measures in Clinical Care: Mixed Methods Study.

Cancer treatment is a key component of health care systems, and the increasing number of cancer medicines is expanding the treatment landscape. However, evidence of the impact on patients has been focused more on chemotherapy toxicity and symptom control and less on the effect of cancer medicines more broadly on patients' lives. Evolving electronic patient-reported outcome measures (ePROMs) presents the opportunity to secure early engagement of patients and clinicians in shaping the collection of quality-of-life metrics and presenting these data to better support the patient-clinician decision-making process. The aim of this study was to obtain initial feedback from patients and clinicians on the wireframes of a digital solution (patient app and clinician dashboard) for the collection and use of cancer medicines ePROMs. We adopted a 2-stage, mixed methods approach. Stage 1 (March to June 2019) consisted of interviews and focus groups with cancer clinicians and patients with cancer to explore the face validity of the wireframes, informed by the technology acceptance model constructs (perceived ease of use, perceived usefulness, and behavioral intention to use). In stage 2 (October 2019 to February 2020), the revised wireframes were assessed through web-based, adapted technology acceptance model questionnaires. Qualitative data (stage 1) underwent a framework analysis, and descriptive statistics were performed on quantitative data (stage 2). Clinicians and patients with cancer were recruited from NHS Greater Glasgow & Clyde, the largest health board in Scotland. A total of 14 clinicians and 19 patients participated in a combination of stage 1 interviews and focus groups. Clinicians and patients indicated that the wireframes of a patient app and clinician dashboard for the collection of cancer medicines ePROMs would be easy to use and could focus discussions, and they would be receptive to using such tools in the future. In stage 1, clinicians raised the potential impact on workload, and both groups identified the need for adequate IT skills to use each technology. Changes to the wireframes were made, and in stage 2, clinicians (n=8) and patients (n=16) indicated it was "quite likely" that the technologies would be easy to use and they would be "quite likely" to use them in the future. Notably, clinicians indicated that they would use the dashboard to enable treatment decisions "with around half" of their patients. This study emphasizes the importance of consulting both patients and clinicians in the design of digital solutions. The wireframes were perceived positively by patients and clinicians who were willing to use such technologies if available in the future as part of routine care. However, challenges were raised, and some differences were identified between participant groups, which warrant further research.

Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes

Historically, there was a tendency amongst electronic clinical outcome assessment (eCOA) service providers and their sponsor clients to prevent changes to eCOA data, particularly for electronic patient-reported outcome (ePRO) measures, or to allow changes to eCOA data but only after receiving sponsor approval to do so. Further, sponsors were also approving or denying data change requests (DCRs).From 2018 to 2022, 45 representatives of Critical Path (C-Path) Institute’s Patient-Reported Outcome (PRO) Consortium, eCOA Consortium (previously ePRO Consortium), and the eClinical Forum collaborated to develop guidelines on changes to eCOA data. These were compiled into the present manuscript, which outlines best practices aligned to latest health authority guidance, and based on expertise from all three organizations.This work coincided with a shift in clinical trial industry practices and emergence of regulations and quality functions that require that investigative sites, not sponsors, be responsible for the maintenance of accurate source records. In other words, the question was not whether, but how, PRO data should be changed. The resulting set of core principles can become the foundation upon which sponsors, investigators and eCOA providers can work together on DCRs.To achieve that, eCOA studies must:• be setup in a manner that minimizes potential user errors;• have a documented oversight plan and documented site staff training;• follow clearly defined and standard workflows–but also mitigate undefined change types;• allow trial documentation per ALCOA+ principles; and• induce sponsors into timely reviews and reconciliations of discordant data (i.e., via sensitivity&amp;nbsp;analysis) and not by arbitrarily overruling the investigators.

Electronic Patient Reported Outcome Measures for Optimal Remote Symptom Management in Advanced Breast Cancer: Embracing Digital Health Technology

ObjectiveTo review the use of electronic patient outcome measures (ePROMs) in advanced breast cancer (ABC) and its effectiveness in supporting remote symptom monitoring. Data SourcesAn overview of published randomized controlled trials using electronic patient-reported outcome measures (ePROMs) in ABC care. ConclusionThe use of ePROMs in ABC care combined with oncology clinical nurse specialist (CNS) interventions has shown that patient-centered care through remote monitoring of disease and treatment symptoms can improve ABC patient outcomes and experience. Implications for Nursing PracticeOncology clinical nurse specialists (CNSs) have an important role in the effective implementation of ePROMs in ABC care. CNSs are considered most appropriate to lead on and respond to ePROMs, addressing complex symptom issues and maximizing the quality of life (QoL) for the ABC patient. CNSs are a crucial link between the patient, primary and secondary level care health professionals, and the ePROM portal for ABC care.

Assessing Patient-Reported Outcomes in Routine Cancer Clinical Care Using Electronic Administration and Telehealth Technologies: Realist Synthesis of Potential Mechanisms for Improving Health Outcomes.

The routine measurement of patient-reported outcomes in cancer clinical care using electronic patient-reported outcome measures (ePROMs) is gaining momentum worldwide. However, a deep understanding of the mechanisms underpinning ePROM interventions that could inform their optimal design to improve health outcomes is needed. This study aims to identify the implicit mechanisms that underpin the effectiveness of ePROM interventions and develop program theories about how and when ePROM interventions improve health outcomes. A realist synthesis of the literature about ePROM interventions in cancer clinical care was performed. A conceptual framework of ePROM interventions was constructed to define the scope of the review and frame the initial program theories. Literature searches of Ovid MEDLINE, Ovid Embase, Scopus, and CINAHL, supplemented by citation tracking, were performed to identify relevant literature to develop, refine, and test program theories. Quality appraisal of relevant studies was performed using the Mixed Methods Appraisal Tool. Overall, 61 studies were included in the realist synthesis: 15 (25%) mixed methods studies, 9 (15%) qualitative studies, 13 (21%) descriptive studies, 21 (34%) randomized controlled trials, and 3 (5%) quasi-experimental studies. In total, 3 initial program theories were developed regarding the salient components of ePROM interventions-remote self-reporting, real-time feedback to clinicians, and clinician-patient telecommunication. The refined theories posit that remote self-reporting enables patients to recognize and report symptoms accurately and empowers them to communicate these to clinicians, real-time feedback prompts clinicians to manage symptoms proactively, and clinician-patient telephone interactions and e-interactions between clinic encounters improve symptom management by reshaping how clinicians and patients communicate. However, the intervention may not achieve the intended benefit if ePROMs become a reminder to patients of their illness and are not meaningful to them and when real-time feedback to clinicians lacks relevance and increases the workload. The key to improving health outcomes through ePROM interventions is enabling better symptom reporting and communication through remote symptom self-reporting, promoting proactive management of symptoms through real-time clinician feedback, and facilitating clinician-patient interactions. Patient engagement with self-reporting and clinician engagement in responding to feedback are vital and may reinforce each other in improving outcomes. Effective ePROM interventions might fundamentally alter how clinicians and patients interact between clinic encounters.