Use Of ePROs Research Articles

Patient motivators of postoperative electronic patient-reported outcome symptom monitoring use in thoracic surgery patients: a qualitative study

BackgroundElectronic patient-reported outcome (ePRO) systems can be used to engage patients in remote symptom monitoring to support postoperative care. We interviewed thoracic surgery patients with ePRO experience to identify factors that influenced use of ePROs to report their symptoms post-discharge.MethodThis qualitative study used semi-structured telephone interviews with adults who underwent major thoracic surgery at an academic medical center in North Carolina. Individuals who enrolled in symptom monitoring, completed at least one ePRO survey, and were reachable by phone for the interview were included. The ePRO surveys assessed 10 symptoms, including validated Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) measures and thoracic surgery-specific questions. Surveys, offered via web-based and automated telephone options, were administered for four weeks post-discharge with alerts sent to clinicians for concerning symptoms. The interviews were guided by the Capability, Opportunity, Motivation model for behavior change (COM-B) and examined factors that influenced patients’ completion of ePRO surveys post-discharge. Team members independently coded interviews and identified themes, informed by COM-B. We report descriptive statistics (demographics, number of surveys completed) and themes organized by COM-B components.ResultsOf 28 patients invited, 25 (89%) completed interviews from July to October 2022. Participants were a median 58 years, 56% female, 80% White, and 56% had a history of malignancy. They completed 131/150 (87%) possible ePRO surveys. For capability, participants reported building ePROs into their routine and having the skills and knowledge, but lacking physical and emotional energy, to complete ePROs. For opportunity, participants identified the ease and convenience of accessing ePROs and providers’ validation of ePROs. Motivators were perceived benefits of a deepening connection to their clinical team, improved symptom management for themselves and others, and self-reflection about their recovery. Factors limiting motivation included lack of clarity about the purpose of ePROs and a disconnect between symptom items and individual recovery experience.ConclusionsPatients described being motivated to complete ePROs when reinforced by clinicians and considered ePROs as valuable to their post-discharge experience. Future work should enhance ePRO patient education, improve provider alerts and communications about ePROs, and integrate options to capture patients’ complex health journeys.

Evidence to support ePRO-based patient care in survivorship for outpatient with advanced upper gastrointestinal cancer.

e13789 Background: The patients with advanced upper gastrointestinal (UGI) cancer reported multiple symptom burdens at diagnosis and after failing multiple chemotherapy lines. Assessing the readiness of patient-reported outcome (PRO) parameters to support evidence-based pathways for monitoring and managing outpatients is an unmet clinical need to integrate PRO into routine outpatient care for UGI cancer patients. This study aims to identify the most relevant PRO parameters that represent the high symptom burden and functioning impairment overtime during chemotherapy for advanced UGI cancer. Methods: Eligible UGI adult cancer patients (N=111) for a new line of chemotherapy were enrolled. Multiple symptoms were assessed electronically for 36 weeks, using The M.D. Anderson Symptom Inventory GI module (MDASI-GI). Longitudinal symptoms burden was analyzed using mixed-effect models adjusted for age, sex, performance status (PS) (good vs. poor PS ( ECOG 0-1 vs. 2-4). Results: Patients who contributed with more than baseline PROs were included in the analysis (n=92). Of those patients, 43 were treatment-naïve, and 49 had received prior therapy. The primary tumor sites include esophageal (32%), gastroesophageal junction (GEJ) (25%), or gastric (40%). All patients at baseline reported the following symptoms at a severe level (score ≥7 on a 0-10 MDASI-GI scale): fatigue, lack of appetite, pain, disturbed sleep, drowsy, and inability to eat. There was no significant difference in the composite score of these symptoms overtime, regardless of disease groups or treatment status at baseline. Patients with poor PS reported a statistically significant severe composite score baseline ( P=.04). Patients who stayed longer in the study during their survivorship reported a decreased prevalence of moderate to severe symptoms (score of ≥ 4) from 51% at baseline to 40% at 12 weeks, 34% at 24 weeks, and to 28% at 36 weeks. Over time, treatment naïve patients had more severe numbness/tingling, while previously treated group had more severe distress. Conclusions: This longitudinal prospective study during survivorship in patients undergoing chemotherapy for advanced UGI cancer provides a set of most distressing symptom burdens that need to be monitored as part of outpatient care. These data support establishing symptom management pathways for routine use of ePRO for screening and triage of, and linking those symptoms to toxicities after chemotherapy for UGI cancer patients.

Identification of best practices for training in remote symptom monitoring using electronic patient-reported outcomes.

441 Background: As remote symptom monitoring (RSM) using electronic patient-reported outcomes (ePROs) is increasingly implemented as part of standard-of-care, practices must be prepared to train diverse clinical teams. Little is known about best practices for training multidisciplinary teams to engage effectively with ePROs. Methods: This quality improvement initiative evaluated a training approach for RSM using Plan Do Study Act (PDSA) cycles conducted in oncology practices at the University of Alabama at Birmingham (UAB). Multiple team members participated in training sessions over the duration of implementation scale-up. Training logs, field notes on barriers, and iterations to the training approach were updated using Excel spreadsheets. A recorded training session was utilized as an update to the training approach conducted via Zoom. Results: Overall, 145 providers (nurses, social workers, navigators, clinicians) were trained. Initial training (PDSA Cycle I) included a Zoom lecture for lay navigators, nurses, and physicians conducted by the physician lead, which included rationale for RSM, provider roles, and technical instruction. Barriers identified included limited knowledge retention and difficulty using ePRO technology in practice. In PDSA Cycle II, training included advanced practice providers. In addition, a nurse champion was added to the training team. Content was split into a lecture for rationale and roles (Zoom or in person, based on provider preference) and one on one hands on in-clinic training on technical aspects of ePRO delivery led by the training manager and nurse champion. While this approach increased engagement, provider turnover necessitating multiple trainings and low knowledge sustainment were barriers. In PDSA Cycle III, additional staff were trained including the intake team, nurse navigators, and social workers. The lecture was recorded for delivery by the training manager or independent viewing. In addition to the initial training, written standard operating procedures for providers, and check-ins or repeat sessions with participants were added for longitudinal engagement. Conclusions: Four key provider training elements were: (1) training more provider types to support the use of ePROs in clinical care delivery; (2) emphasizing in-person technical training by an individual with relevant experience; (3) using asynchronous materials to support both scalability and ongoing support; and (4) including additional sessions with longitudinal one-on-one provider training.

Real-World Use of Electronic Patient-Reported Outcome (ePRO) Tools Integrated in the Electronic Medical Record During Radiation Therapy for Head and Neck Cancer: Feasibility Study.

Purpose Use of electronic patient-reported outcome (ePRO) tools in routine oncology practice can be challenging despite evidence showing they can improve survival, improve patient and practitioner satisfaction, and reduce medical resource utilization. Head and neck cancer (HNC) patients receiving radiation therapy (RT) may be a group that would particularly benefit from interventions focused on early symptom management. Methods Patients undergoing definitive RT for HNC were enrolled in a feasibility study and received ePRO surveys integrated within the electronic medical record (EMR) on a weekly basis during RT. After completion of each ePRO survey, a radiation oncology registered nurse documented the findings and subsequent interventions within the EMR. Results Thirty-four patients with HNC who received curative RT at a single center were enrolled. The total number of surveys completed was 194 with a median of 7 surveys per patient (range 1-8). There was a total of 887 individual abnormal findings reported on the ePROs, and the authors found that all 887 had a corresponding documented intervention. Post-treatment practitioner questionnaires highlighted that ePROs were felt to be helpful for the care team in providing care to HNC patients. Conclusion For patients with HNC receiving RT, ePROs can be effectively utilized to address patient symptoms within an integrated health care system. Creating an infrastructure for the use of ePROs integrated within the EMR in routine care requires an approach that accounts for local workflows and buy-in from patients and the entire care team.

Electronic patient-reported outcomes in clinical kidney practice (ePRO Kidney): a process evaluation of educational support for clinicians.

Patient-reported outcomes (PROs) are increasingly mandated in kidney care to incorporate patients' perspectives. We assessed whether educational support for clinicians using electronic (e)PROs could enhance person-centered care. A process evaluation, using a mixed methods longitudinal comparative concurrent design was undertaken of educational support to clinicians on routine use of ePROs. In two urban home dialysis clinics in Alberta, Canada, patients completed ePROs. At the implementation site, clinicians were provided with ePROs and clinician-oriented education via voluntary workshops. At the non-implementation site, neither were provided. Person-centered care was measured using the Patient Assessment of Chronic Illness Care-20 (PACIC-20). Longitudinal structural equation models (SEMs) compared change in overall PACIC scores. The interpretive description approach, using thematic analysis of qualitative data, further evaluated processes of implementation. Data were collected from questionnaires completed by 543 patients, 4 workshops, 15 focus groups, and 37 interviews. There was no overall difference in person-centered care throughout the study, including after delivery of workshops. The longitudinal SEMs revealed substantial individual-level variability in overall PACIC trajectories. However, there was no improvement at the implementation site and no difference between the sites during both the pre- and post-workshop periods. Similar results were obtained for each PACIC domain. Qualitative analysis provided insights into why there was no substantial difference between sites: (1) clinicians wanted to see kidney symptoms, not quality of life, (2) workshops were tailored to clinicians' educational needs, not patients' needs, and (3) variable use of ePRO data by clinicians. Training clinicians on use of ePROs is complex and likely only part of what is required to enhance person-centered care. NCT03149328. https://clinicaltrials.gov/ct2/show/NCT03149328.

Real-world use and clinical impact of electronic patient-reported outcomes (ePROs) in patients with solid tumors treated with immuno-oncology (IO) therapy.

416 Background: Patients with cancer can experience disease- and treatment-related symptoms that are underreported and underestimated by physicians. This observational, non-interventional study evaluated the use of ePROs and their impact on duration of treatment (DoT) in patients with solid tumors receiving IO therapy in community practice. Methods: Patients initiating index IO therapy immediately prior to (Jan-2017 to Dec-2018) and after (Sep-2019 to Dec-2020) implementation of Noona, the ePRO platform at Tennessee Oncology clinics, were included in a retrospective historical control (HC) and ePRO cohort, respectively, and followed for up to 6 months. The ePRO cohort was further divided into ePRO users (platform enrollment ≤45 days from index) and non-users. ePRO questionnaires, based on Common Terminology Criteria for Adverse Events (CTCAE), were sent within a week after each IO infusion and could be completed using an internet browser or smartphone app. Patient characteristics and DoT were described and compared between the HC and ePRO cohorts and between the HC cohort and ePRO users subgroup. Use of ePROs was evaluated within the ePRO cohort. Differences in baseline characteristics between cohorts were adjusted using Cox proportional hazards models. Results: Data were collected for 538 HC and 1014 ePRO patients (319 ePRO users and 695 non-users). Patient characteristics were generally similar between cohorts, but more HC patients were diagnosed with Stage IV disease (54% vs 47%; p < 0.01) and initiated IO as monotherapy (82% vs 52%), while more ePRO patients initiated IO as combination therapy (48% vs 18%). ePRO users were more likely than non-users to be female, white, married, living with a spouse, and have higher education (college or graduate degree) (all p < 0.05). Use of ePROs was durable over follow-up, with a consistent number of questionnaires sent over Months 1-3 and Months 4-6 (median: 6 questionnaires in each period) and a slight decrease in the number answered (median: 4 vs 3 questionnaires). ePRO patients had a longer DoT than HC patients (median time to end of first IO regimen: not estimable vs 5.1 months). Significantly more ePRO than HC patients remained on their first IO regimen at 6 months (54% vs 46%; p < 0.05). Multivariate Cox regression showed the risk of ending first IO therapy was lower for ePRO versus HC patients (p < 0.05). Conclusions: The increased DoT observed in the ePRO versus HC cohort in this study suggests that use of ePROs may facilitate improved care coordination and enable patients to remain on IO therapy longer. However, ePRO uptake was only 31% in the ePRO cohort, with several social determinants appearing to influence use. Overcoming barriers in ePRO uptake is an area for future study.

A Narrative Review on the Collection and Use of Electronic Patient-Reported Outcomes in Cancer Survivorship Care with Emphasis on Symptom Monitoring.

Electronic patient-reported outcome (ePRO) applications promise great added value for improving symptom management and health-related quality of life. The aim of this narrative review is to describe the collection and use of ePROs for cancer survivorship care, with an emphasis on ePRO-symptom monitoring. It offers many different perspectives from research settings, while current implementation in routine care is ongoing. ePRO collection optimizes survivorship care by providing insight into the patients’ well-being and prioritizing their unmet needs during the whole trajectory from diagnosis to end-of-life. ePRO-symptom monitoring can contribute to timely health risk detection and subsequently allow earlier intervention. Detection is optimized by automatically generated alerts that vary from simple to complex and multilayered. Using ePRO-symptoms during in-hospital consultation enhances the patients’ conversation with the health care provider before making informed decisions about treatments, other interventions, or self-management. ePRO(-symptoms) entail specific implementation issues and complementary ethics considerations. The latter is due to privacy concerns, digital divide, and scarcity of adequately representative data for particular groups of patients.

Feasibility study of integrated ePROs in routine care during radiation therapy for head and neck cancer.

e13612 Background: Use of electronic Patient Reported Outcomes (ePRO) tools in the routine care of cancer patients remains challenging despite data showing that they can improve resource utilization and patient outcomes. Patients with head and neck cancer during intensive therapy with radiation therapy (RT) may particularly benefit from interventions focused on early symptom management. Methods: 34 patients with head and neck cancer were enrolled in an implementation study and received ePROs integrated within the electronic medical record (EMR) weekly during radiation therapy (RT) within a large integrated health care delivery system. ePROs consisted of the FACT G7 and FACT-HN. After completion of each survey on the patient portal, a radiation oncology RN documented any abnormal findings and subsequent interventions using a standardized format within the EMR. If patients did not have access to the patient portal or had language barriers, they could complete ePROs with a translator by phone or video. Results: Between January and December of 2021, 34 patients with head and neck cancer receiving curative RT were enrolled. The median age 65 years (range 46-84). 74% of patients were male. 59% were white, 26% Asian/PI, 5% Black, and 5% Hispanic. The most common primary cancer sites were: oropharynx (32%), nasopharynx (24%), larynx (18%), oral cavity (9%). 65% of patients received concurrent chemotherapy with RT and 35% received RT alone. 97.4% of patients had access to the online portal. The total number of surveys completed was 194 with a median of 7 per patient (range 1-8). There was a total of 887 abnormal findings reported and 887 documented and corresponding interventions resulting in a 100% intervention rate. Over the course of RT the mean number of abnormal findings increased from 2.26 at baseline (n = 34) to 6.27 at week 7 (n = 24), P < 0.0001. Hospitalizations and Emergency Department (ED) visit data were collected during the study and up to 30 days from last day of RT. There was a total of 2 hospitalizations and 8 ED visits. Conclusions: ePROs integrated within the patient portal and EMR are feasible during RT for patients with head and neck cancer within a large integrated health care system. The use of ePROs integrated within the patient portal and EMR can lead to a high rate of intervention. The increasing number of abnormal findings on ePRO during intensive treatment for head and neck cancer is consistent with known patterns of toxicity and confirm the value of studying methods for improving quality of life in this patient population.[Table: see text]

Virtually, Anything is Possible: Implementation of an Electronic Patient Reported Outcome Platform Across A Multi-Center Radiation Oncology Department

Aim: To assess the implementation of an electronic patient reported outcomes (ePRO) application across a multi-center radiation oncology department. Process: Dalhousie University's Department of Radiation Oncology (DRO) is composed of four radiotherapy (RT) centres (Halifax, Sydney, Saint John, Charlottetown) across three provinces. The implementation of ePRO across our centres has been made possible by several key events: In 2009, a Canadian Partnership Against Cancer (CPAC) grant enabled 2 centres to begin paper-based distress screening using the Canadian Problem Checklist (CPC) and Edmonton Symptom Assessment System (ESASr). In 2015, a PRO retreat included representatives from all 4 centres to devise an action plan for ePRO implementation. In 2017, Accreditation Canada mandated routine evaluation of patient outcomes and in 2019, three DRO centres were awarded CPAC funding to launch ePROs. The fourth centre now hopes to use lessons learned in order to facilitate their ePRO implementation. Within the ePRO application (Noona) Canadian Partnership for Quality Radiotherapy (CPQR)-endorsed PRO tools are used to capture patient responses including CPC, ESASr, and the Brief Pain Inventory (BPI). Needs assessments were conducted in the areas of human resource (e.g. administrative support) as well as staff and patient education. Clinic workflows were revised to include an ePRO assessment at consultation, first and last RT review as well as follow-up in clinic or remotely. Official roll-out began in November 2021 with a phased approach across centres and tumors sites to allow for stakeholder and user feedback and to facilitate continued project planning. Benefits/Chellenges: Multi-centre and multi-disciplinary collaboration has been a major enabler of this project with significant potential to expand our Department's clinical and research programs. While the challenge of coordinating such a large-scale initiative was aggravated by constantly changing pandemic restrictions, project priority was escalated across the institutions with recognition of the electronic platform as a powerful tool to assess patient distress/symptoms remotely. While implementation of an ePRO program has been feasible, it has also been complex. Approvals from Privacy Impact Assessments to IT architectural reviews were required. An advisory board was formed to facilitate multi-stakeholder feedback including patient representatives, project managers, clinical clerks, nurses, radiation therapists, radiation oncologists, industry representatives, IT and legal. The project has been dependent on support from cancer program leadership to front line staff. Given that implementation of an ePRO application has introduced change in clinic workflow, change management strategies have been required to obtain buy-in for a system that aims to ultimately improve the quality and efficiency of patient care. Impact / Outcomes: PROs capture the patient perspective on physical, emotional and practical impacts of treatment, with the literature showing benefits to include improved patient-provider communication, patient quality of life and even survival. Future evaluation of the program will hopefully confirm that uptake and efficiency of PROs improves with use of the electronic versus paper system. More importantly, we await data collection and analysis to determine whether our multiple RT centres see improved patient outcomes through use of ePROs.

Electronic Patient-Reported Outcomes in Nephrology: Focus on Hemodialysis.

The success of hemodialysis (HD) treatments has been evaluated using objective measures of analytical parameters, or machine-measured parameters, despite having available validated instruments that assess patient perspective. There is an emerging interest regarding the use and relevance of patient-related outcomes (PROs). Electronic PROs (ePROs) involve the use of electronic technology, provide rapid access to this information, and are becoming more widely used in clinical trials and studies to evaluate efficacy and safety. Despite the scarce literature, this review suggests that ePROs are useful in providing a more customized and multidimensional approach to patient management and in making better clinical decisions in relevant aspects such as vascular access, duration and frequency of dialysis sessions, treatment of anemia, mental health, fatigue, and quality of life. The purpose of this review is to raise interest in the systematic use of ePROs in HD and to promote the development of studies in this field, which can respond to the gaps in knowledge and contribute to the implementation of the use of ePROs through new technologies, helping to improve the quality of health care.

Acceptance, Usage, and Barriers of Electronic Patient-Reported Outcomes Among German Rheumatologists: Survey Study.

BackgroundThe use of patient-reported outcomes (PROs) allows for patient-centered, measurable, and transparent care. Electronic PROs (ePROs) have many benefits and hold great potential to improve current usage of PROs, yet limited evidence exists regarding their acceptance, usage, and barriers among rheumatologists.ObjectiveThis study aims to evaluate the current level of acceptance, usage, and barriers among German rheumatologists regarding the use of ePROs. The importance of different ePRO features for rheumatologists was investigated. Additionally, the most frequently used PROs for patients with rheumatoid arthritis (RA) were identified.MethodsData were collected via an online survey consisting of 18 questions. The survey was completed by members of the Working Group Young Rheumatology of the German Society for Rheumatology (Arbeitsgemeinschaft Junge Rheumatologie der Deutschen Gesellschaft für Rheumatologie [DGRh]) at the 2019 annual DGRh conference. Only members currently working in clinical adult rheumatology were eligible to complete the survey.ResultsA total of 119 rheumatologists completed the survey, of which 107 (89.9%) reported collecting PROs in routine practice and 28 (25.5%) already used ePROs. Additionally, 44% (43/97) were planning to switch to ePROs in the near future. The most commonly cited reason for not switching was the unawareness of suitable software solutions. Respondents were asked to rate the features of ePROs on a scale of 0 to 100 (0=unimportant, 100=important). The most important features were automatic score calculation and display (mean 77.50) and simple data transfer to medical reports (mean 76.90). When asked about PROs in RA, the respondents listed pain, morning stiffness, and patient global assessment as the most frequently used PROs.ConclusionsThe potential of ePROs is widely seen and there is great interest in them. Despite this, only a minority of physicians use ePROs, and the main reason for not implementing them was cited as the unawareness of suitable software solutions. Developers, patients, and rheumatologists should work closely together to help realize the full potential of ePROs and ensure a seamless integration into clinical practice.

Personalized symptom management: a quality improvement collaborative for implementation of patient reported outcomes (PROs) in \u2018real-world\u2019 oncology multisite practices

BackgroundLittle research has focused on implementation of electronic Patient Reported Outcomes (e-PROs) for meaningful use in patient management in ‘real-world’ oncology practices. Our quality improvement collaborative used multi-faceted implementation strategies including audit and feedback, disease-site champions and practice coaching, core training of clinicians in a person-centered clinical method for use of e-PROs in shared treatment planning and patient activation, ongoing educational outreach and shared collaborative learnings to facilitate integration of e-PROs data in multi-sites in Ontario and Quebec, Canada for personalized management of generic and targeted symptoms of pain, fatigue, and emotional distress (depression, anxiety).Patients and methodsWe used a mixed-methods (qualitative and quantitative data) program evaluation design to assess process/implementation outcomes including e-PROs completion rates, acceptability/use from the perspective of patients/clinicians, and patient experience (surveys, qualitative focus groups). We secondarily explored impact on symptom severity, patient activation and healthcare utilization (Ontario sites only) comparing a pre/post population cohort not exposed/exposed to our implementation intervention using Mann Whitney U tests. We hypothesized that the iPEHOC intervention would result in a reduction in symptom severity, healthcare utilization, and higher patient activation. We also identified key implementation strategies that sites perceived as most valuable to uptake and any barriers.ResultsOver 6000 patients completed e-PROs, with sites reaching 51%–95% population completion rates depending on initial readiness. e-PROs were acceptable to patients for communicating symptoms (76%) and by clinicians for treatment planning (80%). Patient experience was better than the provincial average. Compared to the pre-population, we observed a significant reduction in levels of anxiety (p = 0.008), higher levels of patient activation (p = 0.045), and reduced hospitalization rates (12.3% not exposed vs 10.1% exposed, p = 0.034). A pre/post population trend towards significance for reduced emergency department visit rates (14.8% not exposed vs 12.8% exposed, p = 0.081) was also noted.ConclusionThis large-scale pragmatic quality improvement project demonstrates the impact of implementation strategies and a collaborative improvement approach on acceptability of using PROs in clinical practice and their potential for reducing anxiety and healthcare utilization; and improving patient experience and patient activation when implemented in ‘real-world’ multi-site oncology practices.

Satisfaction with care and adherence to treatment when using patient reported outcomes to individualize follow-up care for women with early breast cancer – a pilot randomized controlled trial

Background: The population of breast cancer survivors is increasing as a positive consequence of early detection and enhanced treatment. The disease and treatment associated side-effects or late-effects often impact on quality of life and daily life functions during survivorship. This calls for optimization of follow-up care. We aimed to evaluate the patients’ satisfaction with the care provided, when using electronic patient reported outcomes (ePROs) to individualize follow-up care in women with early breast cancer receiving adjuvant endocrine therapy.Material and methods: Postmenopausal women treated for hormone receptor positive early breast cancer were included in a pilot randomized controlled trial and randomized to receive standard follow-up care with prescheduled consultations every six months or individualized follow-up care with the active use of ePROs to screen for the need of consultations. ePROs were distributed every third month over a two-year period. Primary outcomes were satisfaction with the assigned follow-up care and unmet needs. Secondary outcomes were use of consultations, adherence to treatment and quality of life.Results: Of the 207 consecutive patients who were potentially eligible for the study, 134 women were enrolled (65%). In total 64 women in standard care and 60 women in individualized care were analyzed. No statistically significant differences were reported in relation to satisfaction, unmet needs, adherence to treatment or quality of life. Women in standard care attended twice as many consultations during the two year follow-up period as women in individualized care; 4.3 (95% CI 3.9–4.7) versus 2.1 (95% CI: 1.6–2.6), p < .001.Conclusion: A significant reduction in consultations was observed for the group attending individualized care without compromising the patients’ satisfaction, quality of life or adherence to treatment. For the majority of postmenopausal women treated for early breast cancer, implementation of ePROs to individualize follow-up care was feasible.

The use of electronic patient-reported outcome (ePROs) in the management of radiotherapy head and neck cancer patients – A critical review

Keywords: ePROs, Radiotherapy, head and neck cancer Background: Patient-reported outcomes (PROs) are defined as any aspect of a patient’s health status obtained directly from a patient without interpretation by a healthcare provider1. Historically, PROs were captured using paper-based questionnaires, however the growing popularity of digital platforms has led to the introduction of electronic PROs (ePROs)2. Within the clinical setting ePROs are uniquely placed to flag symptoms causing distress to patients during their cancer pathway, facilitating high quality, patient-centered care3. Despite the increasing prevalence of head and neck (HN) cancer within the UK, outcomes are improving. With this increase in survival, toxicities are important to measure due to the associated debilitating physiological and psychological impact these treatments can cause4. The aim of this review is to evaluate current literature regarding the clinical use of ePROs for patients undergoing radiotherapy to the HN. Method: A critical literature review was conducted using a systemic search of five online health-related databases from January 2008 – March 2019. Results: Sixteen studies were included with this review, the majority feasibility studies, evaluating the viability of administering ePROs. EORTC QLQ-C30 and its HN module QLQ-H&N35 were the most commonly used ePRO tool, both during and following treatment. There was little consensus on the best timing for ePROs. Notably, high compliance rates of completing the questionnaires indicate that patients are willing to engage with PROs. The time taken to complete the questionnaires appears to be acceptable to patients. PRO data was captured prior to clinic reviews, however despite this data being available there was limited evidence evaluating the impact of ePROs data on routine management. Nevertheless, there is emerging evidence of the applicability of ePROs as screening tools to facilitate referrals for multi-disciplinary care. Conclusion: Despite a limited number of studies this review found sufficient evidence supporting the feasibility of ePROs, both during and following radiotherapy treatment, for patients with HN cancer. The practicability of ePROs has been established through assessment of concordance and the burden on patients appears to be minimal and acceptable. Further work is needed to evaluate their clinical and economic utility. Numerical

Computer-based monitoring and evaluation of epilepsy-related health variables and their impact on treatment decision

ObjectiveThis study aimed to determine the effectiveness of electronic patient-reported outcomes (ePROs) with focus on epilepsy-specific quality of life, psychiatric and psychosocial burden, drug side effects, and patient satisfaction via the Computer-based Health Evaluation System (CHES) and to evaluate their impact on treatment regimen. MethodsForty consecutive patients with drug-resistant focal epilepsy undergoing prolonged video-electroencephalography (EEG) monitoring at the Department of Neurology, Innsbruck Medical University were included and randomized to an intervention group (questionnaire results accessible to the physicians) and a control group (questionnaire results inaccessible to the physicians). Patients had to complete questionnaires on the day of admission (T0) and the day of discharge (T1). ResultsOverall, twenty-five patients (25/40, 62.5%) showed abnormal assessment results, twelve of them exclusively due to pathological scores on the Liverpool Adverse Events Profile (LAEP). Mean LAEP score was within the pathological range of 48.8 points (48.8 ± 7.2). The psychosocial burden with respect to the Performance, Socio-Demographic Aspects, Subjective Evaluation (PESOS) scale “fear” (48.7 ± 21.4) was also moderately affected. Moreover, mean anxiety (9.1 ± 4.4) and depression (7.6 ± 4.5) scores were both slightly abnormal. Quality of life (as measured using the Quality of Life Inventory in Epilepsy (QOLIE-31)) was moderately impaired (seizure worry: 46.5 ± 21.3, overall quality of life: 52.6 ± 18.6, well-being: 54.1 ± 16.3, energy–fatigue: 39.4 ± 14.7, cognitive functioning: 41.4 ± 19.5, medication effects: 46.2 ± 23.4, social functioning: 51.1 ± 20.8, and total score: 47.2 ± 12.3). Careful medical history-taking and patient–physician consultations alone failed to detect needs for psychological/psychiatric help in three out of 7 patients in the control group (42.8%). Changes over time in Hospital Anxiety and Depression Scale (HADS) and QOLIE-31 scores were not significant. ConclusionThe use of ePROs was feasible and well accepted in the clinical setting. Treatment-associated adverse effects were the most frequently reported health-related restrictions. In particular, psychometric evaluation by applying ePROs can detect health-related problems in patients with epilepsy.

Praktikabilität und Leistungsfähigkeit von E-Health-Anwendungen bei der Erhebung von Patient Reported Outcomes: Forschungsstand und -bedarf

E-health-based technologies also play an increasing role in the collection of patient- reported outcomes (ePRO). However, it remains unclear how feasible and powerful e-health applications are in the collection of PRO. Therefore, it should be examined to what extent the requirements for the use of technology-based PRO instruments has already been explored in order to allow its broad use in the "e-health world". Specifically, the research focus is on practicability, capability and technical implementation of ePRO. The design of the basic legal requirements for the conduct of PRO interviews and how the challenges of ePRO have already been harmonized here need to be examined.Methods Literature study: selective literature research in Pubmed as well as in the databases of DIMDI, G-BA, FDA and EMA. Current scientific knowledge about hurdles, acceptance and usefulness in relation to sociodemografic factors, health status and technical skills as well as about technical implementation is low. The legal standards for ePRO are restricted only to the composition of the survey instrument and methodology quality criteria. There are no prerequisites for a broad use of ePRO, which is why therapeutic measures should not be based on them. The standards of the legislators must be specified and adapted to the requirements of ePRO. Because the design of the tool surface and the rate of usability can influence the response behavior of the patients, the focus should be on the reliability and validity of ePRO surveys in the context of their implementation in relation to the patients, disease, questionnaire and ePRO-specific variables, which determine the response behavior, in order not to endanger the meaningfulness of PRO surveys.

HealthPROMISE: Utilization of Patient Reported Outcomes to Measure Quality of Life in Inflammatory Bowel Disease

Background: Inflammatory Bowel Disease (IBD) is a chronic condition of the bowel affecting over 1.5 million people in the United States. The recurrent nature of IBD makes affected patients ideal candidates for electronic patient reported outcome (e-PRO) monitoring that centers on enhanced symptom tracking and improved communication with care teams. Objective: The study aims to understand the impact of e-PRO utilization via a prescribed mobile application, HealthPROMISE, on improving patients’ quality of life (QOL). Researchers investigated patients’ use of e-PROs to determine whether physicians change treatment in response to new patient health information, and whether patients’ quality of life changes over the course of the study. Methods: In a pragmatic randomized trial at Mount Sinai Medical Center (MSMC), baseline e-PROs were measured using online questionnaires delivered through the app that assessed health literacy, disease severity, general health status, and demographic information. Patients using HealthPROMISE could update their e-PRO information and receive a disease summary and a graph trending IBD-specific QOL scores (Figure 1). Patients could also communicate over the HealthPROMISE app and discuss results with providers. Results of e-PRO data were then compared with those collected from paper-based instruments in another institution (University of Pittsburgh Medical Center, UPMC) for triangulation (Figure 2). Results: There were 320 patients enrolled in the study. Of these, 162 were randomized to the intervention group (e-PROs), and 158 to the control group. Fatigue and tension were the two most important drivers of poor QOL in both MSMC and UPMC cohorts. Usage data showed that the majority of patients (~75%) continue to actively log into the HealthPROMISE app and update their e-PRO. Overall, QOL improved among HealthPROMISE patients over a mean follow-up of 6 months. At baseline, patients in the intervention arm reported a mean quality of life score of 30.3 ± 11.3. The last available follow-up QOL scores showed improvement among patients using HealthPROMISE to 25.3 ± 11.3 (P<0.001) (Figure 2). Conclusions: This is one of the first randomized controlled trials of app-based PRO measure in IBD patients. A significant improvement in QOL was observed. Longitudinal e-PRO collection in IBD patients is feasible with a high degree of adoption and engagement. IBD patients who participate in their own care (via PRO) and share in decision-making have appreciably improved outcomes when compared to patients who do not.

Evaluation of real-time use of electronic patient-reported outcome data by nurses with patients in home dialysis clinics

BackgroundInternationally, the use of patient-reported outcomes (PROs) is increasing. Electronic PROs (ePROs) offer immediate access of such reports to healthcare providers. The objectives of this study were to assess nurses’ perspectives on the usefulness and impact of ePRO administration in home dialysis clinics and assess patient perceptions of satisfaction with nursing care following use of ePROs.MethodsA concurrent, longitudinal, mixed methods study was conducted over 6 months during home dialysis outpatient clinic visits in two cities. Patients (n = 99) provided ePROs using tablet computers when they visited the clinic on two consecutive occasions approximately 3 months apart. Results were scored, printed, and given to nurses before patient appointments. Patients completed satisfaction items from the Comox Valley Nursing Centre Client questionnaire following their appointments. All clinic nurses (n = 11) participated and they were each interviewed twice, three months and six months after the start of the study.ResultsThe five themes that emerged from the interviews with the nurses include: enhancing focus of the nurses, directing interdisciplinary follow-up, offering support to patients through the process, interpreting results from the visual display, and integrating into workflow.Scores on the Client Questionnaire suggested that patients believed that they received excellent care (97%), and that the nurses perfectly understood their needs (90.9%). However, their satisfaction with care did not change over time when ePRO data was repeatedly provided to their nurses.ConclusionsNurses reported that sharing ePRO data in real-time informed their practice. Although there was no statistically significant change in patient satisfaction scores over time, some patients reported changes and benefits from the use of ePROs. Further research is needed to provide guidance about how ePRO data could enhance person-centered care.

Willingness of Patients with Breast Cancer in the Adjuvant and Metastatic Setting to Use Electronic Surveys (ePRO) Depends on Sociodemographic Factors, Health-related Quality of Life, Disease Status and Computer Skills.

Introduction: Because of the often unfavorable prognosis, particularly for patients with metastases, health-related quality of life is extremely important for breast cancer patients. In recent years, data on patient-relevant endpoints is being increasingly collected electronically; however, knowledge on the acceptance and practicability of, and barriers to, this form of data collection remains limited. Material and Methods: A questionnaire was completed by 96 patients to determine to what extent existing computer skills, disease status, health-related quality of life and sociodemographic factors affect patients' potential willingness to use electronics methods of data collection (ePRO). Results: 52 of 96 (55 %) patients reported a priori that they could envisage using ePRO. Patients who a priori preferred a paper-based survey (pPRO) tended to be older (ePRO 53 years vs. pPRO 62 years; p = 0.0014) and typically had lower levels of education (p = 0.0002), were in poorer health (p = 0.0327) and had fewer computer skills (p = 0.0003). Conclusion: Barriers to the prospective use of ePRO were identified in older patients and patients with a lower quality of life. Given the appropriate conditions with regard to age, education and current health status, opportunities to participate should be provided to encourage patients' willingness to take part and ensure the validity of survey results. Focusing on ease of use of ePRO applications and making applications more patient-oriented and straightforward appears to be the way forward.

Equivalence of electronic and paper-based patient-reported outcome measures.

Electronic formats (ePROs) of paper-based patient-reported outcomes (PROs) should be validated before they can be reliably used. This review aimed to examine studies investigating measurement equivalence between ePROs and their paper originals to identify methodologies used and to determine the extent of such validation. Three databases (OvidSP, Web of Science and PubMed) were searched using a set of keywords. Results were examined for compliance with inclusion criteria. Articles or abstracts that directly compared screen-based electronic versions of PROs with their validated paper-based originals, with regard to their measurement equivalence, were included. Publications were excluded if the only instruments reported were stand-alone visual analogue scales or interactive voice response formats. Papers published before 2007 were excluded, as a previous meta-analysis examined papers published before this time. Fifty-five studies investigating 79 instruments met the inclusion criteria. 53% of the 79 instruments studied were condition specific. Several instruments, such as the SF-36, were reported in more than one publication. The most frequently reported formats for ePROs were Web-based versions. In 78% of the publications, there was evidence of equivalence or comparability between the two formats as judged by study authors. Of the 30 publications that provided preference data, 87% found that overall participants preferred the electronic format. When examining equivalence between paper and electronic versions of PROs, formats are usually judged by authors to be equivalent. Participants prefer electronic formats. This literature review gives encouragement to the further widespread development and use of ePROs.