Electronic health intervention to manage symptoms of immunotherapy in patients with cancer (SOFIA): Results from a randomized controlled pilot trial.

BACKGROUND: For patients receiving immune checkpoint inhibitors, early detection of immune-related adverse events (irAEs) is critical for one's safety. To this end, a smartphone app (SOFIA) was developed that featured the assessment of electronic patient-reported outcomes (ePROs) focusing on irAEs as well as a set of comprehensive supportive information. Its feasibility and preliminary efficacy were evaluated in a randomized controlled trial (RCT). METHODS: Patients who received immune checkpoint inhibition therapy were randomly assigned to an intervention group (IG) or a control group (CG; care as usual). During the 12-week intervention period, IG patients used SOFIA to report twice weekly ePROs and receive cancer- and immunotherapy-relevant contents. Before a patient's next clinical visit, the physician in charge was given the ePRO reports. The primary objective was to test the feasibility of SOFIA. Furthermore, the preliminary efficacy of SOFIA for health-related quality of life (HRQOL), psychosocial outcomes, and medical data was examined. Clinical outcomes were assessed at baseline (T0), post-intervention (T1), and a 3-month follow-up (T2). RESULTS: Seventy-one patients were randomized to the IG (n = 34) or the CG (n = 37). SOFIA showed high feasibility and acceptance. At T1, patients in the IG reported significantly better HRQOL and role functioning and less depression, distress, and appetite loss. No significant differences were revealed regarding medical data, the utilization of supportive care services, or survival. CONCLUSIONS: SOFIA showed high feasibility and acceptance and improved HRQOL and psychosocial outcomes. These results suggest further evaluation of efficacy in a large-scale confirmatory multicenter RCT.

The Growing Role of Digital Health Tools in the Care of Patients with Cancer: Current Use, Future Opportunities, and Barriers to Effective Implementation.

PURPOSE OF REVIEW: This article aims to describe the ways in which digital health technologies are currently being used to improve the delivery of cancer care, highlight opportunities to expand their use, and discuss barriers to effective and equitable implementation. RECENT FINDINGS: The utilization of digital health tools and development of novel care delivery models that leverage such tools is expanding. Recent studies have shown feasibility and increased implementation in the setting of oncologic care. With technological advances and key policy changes, utilization of digital health tools has greatly increased over the past two decades and transformed how cancer care is delivered. As digital health tools are expanded and refined, there is potential for improved access to and quality and efficiency of cancer care. However, careful consideration should be given to key barriers of digital health tool adoption, such as infrastructural, patient-level, and health systems-level challenges, to ensure equitable access to care and improvement in health outcomes.

A comprehensive supportive care program for fine-tuning cancer immunotherapy.

Supportive care has become a new pilar of modern oncology, and a great deal of research is being conducted in that area, especially on immune checkpoint inhibitors (ICIs), to help fine-tune immunotherapy. Four major areas of supportive care can enhance responsiveness to cancer immunotherapy whilst minimizing adverse effects: diet (indirectly, by modulating the microbiota or directly, by modulating the immune system), physical activity (by modulating the immune system), electronic patient-reported outcomes (ePRO) (by detecting and treating immune-related adverse events early on), and co-medication management (to possibly suppress those drugs that negatively affect the efficacy of ICIs). Therefore, patients treated with ICIs could receive a systematic multimodal supportive care program encompassing regular nutritional counseling, regular physical activity under the supervision of a physical activity professional, ePRO follow-up, and regular pharmaceutical counseling. This type of approach needs to be evaluated in well-conducted randomized clinical trials.

The real experience of reporting electronic patient-reported outcomes in patients with inflammatory arthritis and factors influencing participation: a scoping review.

Inflammatory arthritis can result in pain, stiffness, fatigue, and reduce quality of life. Frequent monitoring of disease activity is necessary for patients with inflammatory arthritis, and electronic patient-reported outcomes (ePROs) play a crucial role in this process. This study aimed to investigate the real experience of reporting ePROs in patients with inflammatory arthritis, as well as to identify factors influencing participation. The ultimate goal was to inform targeted strategies and develop interventions to enhance the utilization of ePROs in clinical settings. A scoping review was performed using PubMed, Web of science, Embase, and the Cochrane library from 2000 to the present and the literature search focused on the experience of reporting ePROs in inflammatory arthritis and the factors that influence participation. Screening articles based on inclusion and exclusion criteria. A total of 1478 studies were identified, out of which 26 were included in the review. The top experience of applications/platforms in patients was that they were easy to use and that the applications were clear, logical and intuitive. A summary of 18 potential influencing factors were identified and there was inconsistent evidence for five of these factors. The participation of reporting ePROs is influenced by various factors, and the experience is a crucial aspect in patients with inflammatory arthritis. Analyzing patients' experience and influencing factors provides a theoretical basis for future interventions to facilitate the clinical application of ePRO. However, further research is needed to fully understand the association between influencing factors and intervention outcomes.

Predictors for response to electronic patient-reported outcomes in routine care in patients with rheumatoid arthritis: a retrospective cohort study.

Routine collection of electronic patient-reported outcomes (ePROs) can improve clinical care. However, a low response rate may counteract the benefits. To optimize adoption, the aim of this study was to investigate which patient factors and/or timing of the invitation predicted response to ePROs sent prior to consultations in patients with rheumatoid arthritis. We performed a retrospective database study with clinical data collected as part of usual care from the electronic medical records at Reade Amsterdam. The dataset comprised the email invitations to complete the ePRO sent prior to consultation. Multiple patient factors and factors defining the timing of the invitation were investigated if they predicted response to the ePRO through a multivariable logistic generalized estimating equation analysis. In total, 17.070 ePRO invitations were sent to 3194 patients (mean age 60 (SD 14), 74% female), of which 40% was completed. Patients between 55 and 73 years (OR 1.39, 95%CI 1.09-1.77) and with higher social economic status (SES) (OR 1.51, 95%CI 1.22-1.88) had significantly higher odds for completing the ePRO, while patients living in an urban area had lower odds (OR 0.69, 95% CI 0.62-0.76). In year 4 after implementation, the OR was increased to 3.69 (95% CI 2.91-4.90). The implementation of ePROs in daily clinical practice needs improvement since 40% of the ePROs sent prior to consultations were completed. Patients that had higher odds to report the next ePRO were between the age of 55-73, had a higher socio-economic status, and were residents in a rural area. The adoption of reporting the PRO increased over time, but the timing of the prompt did not predict response. Additional research is needed to understand ePRO completion, especially for patients with lower socio-economic status.

Facilitators and barriers to adhere to monitoring disease activity with ePROs: a focus group study in patients with inflammatory arthritis.

Telemonitoring disease activity with electronic patient-reported outcomes (ePROs) may reduce the workload of rheumatic care by decreasing outpatient clinic visits. However, low adherence to reporting ePROs is frequently observed. Our objective was to identify facilitators and barriers to weekly monitoring of disease activity with ePROs. Patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) who recently participated in one of the two telemonitoring studies with ePROs completed in a smartphone app, were invited to participate in focus group discussions (FGD). Thematic analysis was used to identify themes that play a role in the decision to continue or stop reporting weekly ePROs. A total of 22 patients participated in three FGDs. Five themes were identified that were of importance to adhere to telemonitoring: (1) questionnaire frequency, (2) discussing results of completed ePROs, (3) physical consultations, (4) patient insight into disease activity and (5) user experience of the app. All themes contained both barrier and facilitator elements. The results suggest that to improve adherence to telemonitoring of disease activity with ePROs, the perceived benefits of completing ePROs should be maximized. This can be done by providing patients the ability to skip (unneeded) physical consultations in case of low disease activity, and training clinicians to always discuss the completed ePROs. In addition, it is essential to reduce the effort to report ePROs, by tailoring the frequency of ePROs based on the patients' disease activity or preference, aiming for optimal app functionality as well as by sending notifications when new ePROs are available.

Correlation Between Remote Symptom Reporting by Caregivers and Adverse Clinical Outcomes: Mixed Methods Study.

BACKGROUND: Timely collection of patient-reported outcomes (PROs) decreases emergency department visits and hospitalizations and increases survival. However, little is known about the outcome predictivity of unpaid informal caregivers' reporting using similar clinical outcome assessments. OBJECTIVE: The aim of this study is to assess whether caregivers and adults with cancer adhered to a planned schedule for electronically collecting patient-reported outcomes (PROs) and if PROs were associated with future clinical events. METHODS: We developed 2 iPhone apps to collect PROs, one for patients with cancer and another for caregivers. We enrolled 52 patient-caregiver dyads from Kaiser Permanente Northern California in a nonrandomized study. Participants used the apps independently for 4 weeks. Specific clinical events were obtained from the patients' electronic health records up to 6 months following the study. We used logistic and quasi-Poisson regression analyses to test associations between PROs and clinical events. RESULTS: Participants completed 97% (251/260) of the planned Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) surveys and 98% (254/260) of the Patient-Reported Outcomes Measurement Information System (PROMIS) surveys. PRO-CTCAE surveys completed by caregivers were associated with patients' hospitalizations or emergency department visits, grade 3-4 treatment-related adverse events, dose reductions (P<.05), and hospice referrals (P=.03). PROMIS surveys completed by caregivers were associated with hospice referrals (P=.02). PRO-CTCAE surveys completed by patients were not associated with any clinical events, but their baseline PROMIS surveys were associated with mortality (P=.03), while their antecedent or final PROMIS surveys were associated with all clinical events examined except for total days of treatment breaks. CONCLUSIONS: In this study, caregivers and patients completed PROs using smartphone apps as requested. The association of caregiver PRO-CTCAE surveys with patient clinical events suggests that this is a feasible approach to reducing patient burden in clinical trial data collection and may help provide early information about increasing symptom severity.

Electronic patient-reported monitoring of symptoms during follow-up of ovarian cancer patients: a feasibility study.

BACKGROUND: Ovarian cancer patients require monitoring for relapse. Innovative follow-up methods are increasingly being explored. An electronic patient-reported outcome (ePRO) follow-up pathway was developed for women treated for ovarian cancer. This feasibility study explored patient acceptability and compliance. METHODS: A single-arm non-blinded prospective feasibility study was undertaken at two hospitals. Participants were women who had completed treatment for ovarian cancer whose clinician was happy for them to be monitored remotely. Automated 3-monthly reminders were sent to participants to complete an ePRO questionnaire and obtain blood tests. Participants were reviewed over the phone by their clinical nurse specialist instead of attending clinic-based follow-up. The primary outcome was compliance (expected ePRO completions/blood tests) across the 12-month study period. Secondary outcomes were recruitment, attrition, resource use, symptom severity/alerts and patient acceptability. RESULTS: Twenty-four women consented (50% consent rate), and 13 remained on study at 12 months. Seven women relapsed, 3 chose to withdraw, and 1 withdrew for other clinical reasons. ePRO compliance was high and consistent at 75-82%, although the two hospitals differed. Adherence to the clinical protocol was evident for blood tests and contacts with staff (fewer visits, more phonecalls compared to an earlier audit). End-of-study feedback indicated high patient satisfaction. CONCLUSIONS: Remote ePRO follow-up for ovarian cancer is feasible and acceptable to patients who are able and willing to participate. However, the low recruitment rate (ineligible + declined) indicate it is not suitable/acceptable to all patients immediately post-treatment. Further large-scale research and implementation work is required, especially in a post-COVID era. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02847715 (first registered 19/05/2016).

Usability and acceptability of the electronic self-assessment and care (eSAC) program in advanced ovarian cancer: A mixed methods study.

OBJECTIVE: To determine usability and acceptability of the electronic self-assessment and care (eSAC) web-based, patient reported outcome (PRO) program for people with advanced ovarian cancer. METHODS: Patient participants recruited from a single ambulatory site were prompted by email to answer symptom/quality of life items prior to each clinic visit. Patient participant acceptability was measured with the Acceptability E-Scale Score (AES). Usability was measured among a subset of patient participants using semi-structured interviews. Clinician participant acceptability and usability were measured via survey and semi-structured interviews. Quantitative data were analyzed with descriptive statistics. Qualitative data were analyzed using thematic content analysis. A mixed methods analysis was performed. RESULTS: Of 163 eligible patients approached, 143 (87.7%) provided written consent. Patient participants (n = 71) who created an eSAC report prior to at least 3 clinic visits, rated eSAC as acceptable with a mean AES score of 26.19 ± 3.36 (out of 30). Interview data from patient participants (n = 33) revealed that eSAC was easy to use and important to the clinic visit conversation. Data from clinician surveys (n = 8) and focus groups (n = 3) revealed that the eSAC program was acceptable and useful for clinicians. Qualitative analysis suggested process improvements from patients and clinicians for effectiveness in the advanced ovarian cancer setting. Mixed methods analysis demonstrated no major discrepancies between quantitative and qualitative findings, with the qualitative data broadening understanding of quantitative ratings. CONCLUSION: eSAC was useful and acceptable in this setting. This PRO is a promising strategy for enhancing patient-centered care for people with advanced ovarian cancer.

'We do need to keep some human touch'-Patient and clinician experiences of ovarian cancer follow-up and the potential for an electronic patient-reported outcome pathway: A qualitative interview study.

OBJECTIVE: This study aimed to explore experiences of follow-up after treatment and views on an electronic patient-reported outcome (ePRO) pathway among ovarian cancer patients and clinicians. METHODS: Semi-structured qualitative interviews were conducted with clinicians and patients previously treated for ovarian cancer. Interviews explored experiences of the current follow-up pathway, patients' needs and views on an ePRO pathway enabling patients to report symptoms online rather than attend clinic-based appointments. Transcripts were analysed using framework analysis. RESULTS: Sixteen patients and 10 clinicians participated from four hospitals in England. Four key themes were identified: transition into follow-up, key features of effective follow-up, issues in follow-up and views of ePRO. Both patients and clinicians saw benefits of an ePRO pathway alongside continued access to specialist support and discussed various practicalities (e.g., frequency, introduction and communication). Technology concerns and feelings of abandonment were highlighted as barriers. The proposed impact on clinical and individual patient outcomes was discussed. CONCLUSION: Patient and clinician views on follow-up and an ePRO pathway informed key recommendations on the development/introduction of ePRO follow-up. Technology use in healthcare will continue to grow and may offer solutions to facilitate responsive and tailored care. Further research should explore the safety, experiences and acceptability of ePRO follow-up.

Implementation of an Electronic Patient-Reported Outcome App for Health-Related Quality of Life in Breast Cancer Patients: Evaluation and Acceptability Analysis in a Two-Center Prospective Trial.

BACKGROUND: One in eight women is diagnosed with breast cancer in the course of their life. As systematic palliative treatment has only a limited effect on survival rates, the concept of health-related quality of life (HRQoL) was developed for measurement of patient-centered outcomes. Various studies have already demonstrated the reliability of paper-based patient-reported outcome (pPRO) and electronic patient-reported outcome (ePRO) surveys and that the 2 means of assessment are equally valid. OBJECTIVE: The aim of this study was to analyze the acceptance and evaluation of a tablet-based ePRO app for breast cancer patients and to examine its suitability, effort, and difficulty in the context of HRQoL and sociodemographic factors. METHODS: Overall, 106 women with adjuvant or advanced breast cancer were included in a 2-center study at 2 major university hospitals in Germany. Patients were asked to answer HRQoL and PRO questionnaires both on a tablet on-site using a specific eHealth assessment website and on paper. The suitability, effort, and difficulty of the app and self-reported technical skills were also assessed. Only the results of the electronically acquired data are presented here. The results of the reliability of the pPRO data have already been published elsewhere. RESULTS: Patients regarded the ePRO assessment as more suitable (80/106, 75.5%), less stressful (73/106, 68.9%), and less difficult (69/106, 65.1%) than pPRO. The majority of patients stated that ePRO assessment improves health care in hospitals (87/106, 82.1%). However, evaluation of ePROs depended on the level of education (P=.003) in the dimensions of effort and difficulty (regression analysis). The app was rated highly in all categories. HRQoL data and therapy setting did not show significant correlations with the app's evaluation parameters. CONCLUSIONS: The results indicate that ePRO surveys are feasible for measuring HRQoL in breast cancer patients and that those patients prefer ePRO assessment to pPRO assessment. It can also be seen that patients consider ePRO assessment to improve hospital health care. However, studies with larger numbers of patients are needed to develop apps that address the needs of patients with lower levels of education and technical skills.

Racial differences in user experiences and perceived value of electronic symptom monitoring in a cohort of black and white bladder and prostate cancer patients.

PURPOSE: Electronic patient-reported outcomes (ePROs) are increasingly being used for symptom monitoring during routine cancer care, but have rarely been evaluated in diverse patient populations. We assessed ePRO user experiences and perceived value among Black and White cancer patients. METHODS: We recruited 30 Black and 49 White bladder and prostate cancer patients from a single institution. Participants reported symptoms using either a web-based or automated telephone interface over 3 months and completed satisfaction surveys and qualitative interviews focused on user experiences and value. Using a narrative mixed methods approach, we evaluated overall and race-specific differences in ePRO user experiences and perceived value. RESULTS: Most participants selected the web-based system, but Blacks were more likely to use the automated telephone-based system than Whites. In satisfaction surveys, Whites more commonly reported ease in understanding and reporting symptoms compared with Blacks. Blacks more often reported that the ePRO system was helpful in facilitating symptom-related discussions with clinicians. During interviews, Blacks described how the ePRO helped them recognize symptoms, while Whites found value in better understanding and tracking symptoms longitudinally. Blacks also expressed preferences for paper-based ePRO options due to perceived ease in better understanding of symptom items. CONCLUSION: Electronic patient-reported outcomes are perceived as valuable for variable reasons by Black and White cancer populations, with greater perceived value for communicating with clinicians reported among Blacks. To optimize equitable uptake of ePROs, oncology practices should offer several ePRO options (e.g., web-based, phone-based), as well as paper-based options, and consider the e-health literacy needs of patients during implementation.

Patient experiences of an electronic PRO tailored feedback system for symptom management following upper gastrointestinal cancer surgery.

PURPOSE: Complications following upper gastrointestinal (UGI) surgery are common. Symptom-monitoring following discharge is not standardized. An electronic patient-reported outcome (ePRO) system providing feedback to patients and clinicians could support patients and improve outcomes. Little is known about patients' experiences of using such systems. This qualitative sub-study explored patients' perspectives of the benefits of using a novel ePRO system, developed as part of the mixed methods eRAPID pilot study, to support recovery following discharge after UGI surgery. METHODS: Patients completed the online ePRO symptom-report system post-discharge. Weekly interviews explored patients' experiences of using ePRO, the acceptability of feedback generated and its value for supporting their recovery. Interviews were audio-recorded and targeted transcriptions were thematically analysed. RESULTS: Thirty-five interviews with 16 participants (11 men, mean age 63 years) were analysed. Two main themes were identified: (1) reassurance and (2) empowerment. Feelings of isolation were common; many patients felt uninformed regarding their expectations of recovery and whether their symptoms warranted clinical investigation. Participants were reassured by tailored feedback advising them to contact their care team, alleviating their anxiety. Patients reported feeling empowered by the ePRO system and in control of their symptoms and recovery. CONCLUSION: Patients recovering at home following major cancer surgery regarded electronic symptom-monitoring and feedback as acceptable and beneficial. Patients perceived that the system enhanced information provision and provided a direct link to their care team. Patients felt that the system provided reassurance at a time of uncertainty and isolation, enabling them to feel in control of their symptoms and recovery.

Feasibility Study of Three-Phase Implementation of International Consortium for Health Outcomes Measurement Depression and Anxiety Standard Set in an Outpatient Consultation-Liaison Psychiatry Practice.

OBJECTIVE: We describe a three-phase implementation of the International Consortium for Health Outcomes Measurement Depression and Anxiety Standard Set in a Consultation-Liaison Psychiatry practice. METHODS: During the preintervention phase, we reviewed patient-reported outcome tools and engaged stakeholders and leadership. During phase 1, the standard set was converted into an electronic previsit intake assessment that was implemented in a physician champion's practice. Patients completed the intake on a tablet, and computer adaptive testing was used to reduce response burden. Physician-facing data display facilitated use during subsequent in-person visits. An electronic version of the follow-up standard set was used during follow-up visits. During phase 2, a second physician tested scalability and the intervention was disseminated department wide in phase 3. RESULTS: During phase 1, 186 intakes and 67 follow-up electronic patient-reported outcome sets were completed. Average patient age was 54 years, and 44% were male. On average, patients ranked the tool 4.4 out of 5 and spent 22 minutes completing the intake. Time-driven activity-based costing found the new process to be cost-effective. During phase 2, 386 patients completed electronic patient-reported outcome sets, with 315 follow-up visits. Patients ranked the tool as 4.0 out of 5 and spent 26 minutes completing the questions. During phase 3, 2166 patients completed intake electronic patient-reported outcome sets and 1249 follow-up visits. Patients ranked the tool 4.3 out of 5 and spent 26 minutes on it. Scores and completion time did not differ greatly between phases. CONCLUSIONS: Integration of the International Consortium for Health Outcomes Measurement Depression and Anxiety Standard Set is feasible. Future research comparing International Consortium for Health Outcomes Measurement set with other approaches and in different settings is needed.

Collection of electronic patient-reported symptoms in patients with advanced cancer using Epic MyChart surveys.

BACKGROUND: Use of electronic patient-reported outcomes (ePROs) in routine cancer care can help identify troublesome symptoms and facilitate discussions between patients and clinicians and has been shown to improve patient satisfaction, quality of life, and survival. METHODS: Eighty patients with stage IV non-hematologic malignancies on chemotherapy participated. Patient-Reported Symptom Monitoring (PRSM) surveys were sent every 14 days via the Epic MyChart system over a 12-week period. Surveys were offered via phone or paper if patients failed to complete the automated MyChart survey by day 16. Severe symptoms or concerning symptom trends were automatically highlighted in reports for clinic staff. Patients reporting severe symptoms were routed to oncology nursing triage for standard symptom care management. RESULTS: Two hundred seventy-one surveys were sent during the 12-week study period. One hundred eighty-three surveys (66%) were completed, with 68% completed electronically via MyChart, 25% by paper, and 7% by phone call from a research coordinator. At least one severe symptom was reported on 36% of all surveys. However, most severe symptoms did not result in urgent triage follow-up because they were already being addressed and/or patients felt they were manageable. Patients and clinicians generally said the ePRO was efficient and helpful for addressing distressing symptoms and would use it in routine oncology care. CONCLUSION: ePROs can be integrated into the electronic health record using the Epic MyChart system. Patients and clinicians gave positive feedback on the system. Monitoring symptoms in real time may soon become part of standard oncology practice and requires seamless methods for collection.

Key methodological considerations for usability testing of electronic patient-reported outcome (ePRO) systems.

INTRODUCTION: Recent advances in information technology and improved access to the internet have led to a rapid increase in the adoption and ownership of electronic devices such as touch screen smartphones and tablet computers. This has also led to a renewed interest in the field of digital health also referred to as telehealth or electronic health (eHealth). There is now a drive to collect these PROs electronically using ePRO systems. METHOD: However, the user interfaces of ePRO systems need to be adequately assessed to ensure they are not only fit for purpose but also acceptable to patients who are the end users. Usability testing is a technique that involves the testing of systems, products or websites with participants drawn from the target population. Usability testing can assist ePRO developers in the evaluation of ePRO user interface. The complexity of ePRO systems; stage of development; metrics to measure; and the use of scenarios, moderators and appropriate sample sizes are key methodological issues to consider when planning usability tests. CONCLUSION: The findings from usability testing may facilitate the improvement of ePRO systems making them more usable and acceptable to end users. This may in turn improve the adoption of ePRO systems post-implementation. This article highlights the key methodological issues to consider and address when planning usability testing of ePRO systems.

Measurement of equivalence between the web and paper versions of the Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire.

Objectives: Digitised patient-reported outcome may be beneficial for physicians and patients. The Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JHEQ) can only be completed with paper and pencil (pJHEQ). We newly developed a web version of the JHEQ (wJHEQ). This study aimed to determine whether the scores obtained with the wJHEQ are equivalent to those from the pJHEQ, how much the wJHEQ would decrease missing answers, and which JHEQ the participants preferred to use.Methods: To measure equivalence between the pJHEQ and wJHEQ, we evaluated the mean score difference for each subscale (pain, movement, mental) and Visual Analogue Scale (VAS; satisfaction, right hip pain, left hip pain) and then assessed the intraclass correlation coefficients (ICC) between the two scores. ICC values ≥0.75 were defined as excellent agreement. We used Bland-Altman analysis to assess level of agreement between the values of the two questionnaires. We compared the number of incomplete forms and amount of missing data between the two questionnaires. We investigated ease of use by asking the participants which format was easier to use.Results: This study comprised 113 patients (mean age 58.1 years, 81% female) with hip disease. Mean score differences for each subscale between the wJHEQ and pJHEQ were not significantly different. The values of ICC for each subscale and each VAS were all >0.75. All 113 participants completed the wJHEQ questionnaire, whereas nine patients did not complete the pJHEQ form. There was a significant statistical difference between the completion rate of the wJHEQ and that of the pJHEQ (p = .0017). Fifty-seven participants (55%) preferred the wJHEQ, whereas 33 participants (32%) preferred the pJHEQ.Conclusion: The wJHEQ was found to be equivalent to the original pJHEQ. The wJHEQ significantly decreased the numbers of missing answers and incomplete forms. The participants felt ease of use was nearly equivalent. The wJHEQ might help facilitate more complete assessments in clinical trials and research.

Use of Electronic Patient-Reported Outcomes in the Care of Patients with Kidney Failure.

This article in the "Exploring the Evidence" series provides nephrology nurses and clinicians with a description of what electronic patient-reported outcomes (ePROs) and patient-reported outcome measures (PROMs) entail, as well as an understanding of how they can be used in nephrology patient care. Specifically highlighted are some questions and issues that clinicians have raised in our various research studies that have explored ePRO use and integration in the movement toward person-centered kidney care (Schick-Makaroff, 2017; Schick-Makaroff and Molzahn, 2014, 2015, 2017; Schick-Makaroff, Tate et al., 2019).

Usability testing of EirV3-a computer-based tool for patient-reported outcome measures in cancer.

PURPOSE: Eir version 3 (V3) is an electronic tool for administration of patient-reported outcome measures (Eir-Patient) that immediately presents patient scores on the physician's computer (Eir-Doctor). Perceived usability is an important determinant for successful implementation. The aim of this study was to answer the following research question evaluated at the cancer outpatient clinics, in the patients' home, and at general practitioners' (GPs) offices: What are the number, type, and severity of usability issues evaluated by the patient (Eir-Patient module) and by the physician (Eir-Doctor module)? METHODS: A usability evaluation using observations, think-aloud sessions, individual interviews and focus group interviews in cancer patients and their physicians was conducted. Identified usability issues were graded on a severity scale from 1 (irritant) to 4 (unusable). RESULTS: Overall, 73 Eir registrations were performed by 37 patients, and used by 17 physicians in clinical consultations. All patients were able to complete the Eir-Patient symptom registration. Seventy-two usability issues were identified. None of them were graded as unusable. For the Eir-Patient module, 62% of the identified usability issues was graded as irritant (grade 1), 18% as moderate (grade 2), and 20% as severe (grade 3). For the Eir-Doctor module, 46% of the identified usability issues were graded as irritant, 36% as moderate and 18% as severe. CONCLUSIONS: In the updated Eir version, issues in the severe and moderate categories have been changed, to optimize the usability of using real-time PROMs in clinical practice.

Measurement Equivalence of Patient-Reported Outcome Measure Response Scale Types Collected Using Bring Your Own Device Compared to Paper and a Provisioned Device: Results of a Randomized Equivalence Trial.

OBJECTIVES: The aim of this study was to assess the measurement equivalence of individual response scale types by using a patient reported outcome measure (PROM) collected on paper and migrated into electronic format for use on the subject's own mobile device (BYOD) and on a provisioned device (site device). METHODS: Subjects suffering from chronic health conditions causing daily pain or discomfort were invited to participate in this single-site, single visit, three-way crossover study. Association between individual item and instrument subscale scores was assessed by using the intraclass correlation coefficient (ICC) and its CI. Participant attitudes toward the use of BYOD in a clinical trial were assessed through use of a questionnaire. RESULTS: In this study, 155 subjects (females 83 [54%]; males 72 [46%]) ages 19 to 69 years (mean ± SD: 48.6 ± 13.1) were recruited. High association between the modes of administration (paper, BYOD, site device) was shown with analysis of ICCs (0.79-0.98) for each response scale type, including visual analogue scale, numeric rating scale, verbal response scale, and Likert scale. Of the subjects, 94% (146 of 155) stated that they would definitely or probably be willing to download an app onto their own mobile device for a forthcoming clinical trial. Forty-five percent of subjects felt BYOD would be more convenient compared with 15% preferring a provisioned device (40% had no preference). CONCLUSIONS: This study provides strong evidence supporting the use of BYOD for PROM collection in terms of the conservation of instrument measurement equivalence across the most widely used response scale types, and high patient acceptance of the approach.