Patient-reported Outcomes Platform Research Articles

Physical symptoms and anxiety and depression in older patients with advanced cancer in China: a network analysis

BackgroundLittle is understood about the association between psychosomatic symptoms and advanced cancer among older Chinese patients.MethodsThis secondary analysis was part of a multicenter cross-sectional study based on an electronic patient-reported outcome platform. Patients with advanced cancer were included between August 2019 and December 2020 in China. Participants (over 60 years) completed the MD Anderson Symptom Inventory (MDASI) and Hospital Anxiety and Depression Scale (HADS) to measure symptom burden. Network analysis was also conducted to investigate the network structure, centrality indices (strength, closeness, and betweenness) and network stability.ResultsA total of 1022 patients with a mean age of 66 (60–88) years were included; 727 (71.1%) were males, and 295 (28.9%) were females. A total of 64.9% of older patients with advanced cancer had one or more symptoms, and up to 80% had anxiety and depression. The generated network indicated that the physical symptoms, anxiety and depression symptom communities were well connected with each other. Based on an evaluation of the centrality indices, ‘distress/feeling upset’ (MDASI 5) appears to be a structurally important node in all three networks, and ‘I lost interest in my own appearance’ (HADS-D4) had the lowest centrality indices. The network stability was relatively high (> 0.7).ConclusionThe symptom burden remains high in older patients with advanced cancer in China. Psychosomatic symptoms are highly interactive and often present as comorbidities. This network can be used to provide targeted interventions to optimize symptom management in older patients with advanced cancer in China.Trial registrationChinese Clinical Trial Registry (ChiCTR1900024957), registered on 06/12/2020.

Use of PROMIS to capture patient reported outcomes over time for patients on I-SPY2.

611 Background: Patient reported outcomes (PROs) capture direct feedback from patients in clinical trials. The NIH Patient-Reported Outcomes Measurement Information System (PROMIS) is an open source and validated PRO platform. Data on PROMIS score trajectories over time for breast cancer patients undergoing neoadjuvant chemotherapy (NAC) are limited. Methods: We administered paper surveys to patients enrolled on the I-SPY2 trial, a multicenter, randomized phase 2 trial comparing novel agents to standard NAC in high-risk breast cancer. PRO domains included PROMIS Physical Function, Anxiety, Depression, Applied Cognition and Fatigue. Surveys were administered at baseline (post-consent), C1D1, inter-regimen (~12 wks into NAC), pre-surgery and at 1, 6, 12, and 24 months post-surgery. Responses were scored using the HealthMeasures Scoring Service to generate a standardized T score, with a score of 50 representing the general US population mean. Higher Anxiety, Depression and Fatigue scores represent worse symptoms; higher Physical Function and Applied Cognition scores represent better symptoms. We calculated average scores by time-point and compared changes from baseline to various grouped time points using a paired t-test. Results: From 1/2012 to 7/2020, 1631 patients enrolled in I-SPY 2 with 959 completing the baseline survey. 62% had at least two “on-treatment” surveys, and 52% had at least one follow-up time-point. Average baseline PROMIS scores for Physical Function, Anxiety, Depression, Applied Cognition and Fatigue were 46.7, 55.1, 47.2, 53.3 and 46.0 respectively. Between baseline and the latest on-treatment time point we observed improvement in Anxiety (-5.2) and worsening in Physical Function, Applied Cognition and Fatigue (-5.4, -6.9 and +8.2 respectively). Between baseline and the latest post-surgery time point, we saw improved Anxiety (-5.9) and worsened Physical Function, Applied Cognition and Fatigue (-5.9, -3.6 and +4.3). Depression changed minimally. Conclusions: Using PROMIS, patients on I-SPY2 experienced worse Physical Function, Applied Cognition and Fatigue but improved Anxiety during and after treatment compared to baseline. While changes in Applied Cognition and Fatigue recovered partially after treatment, Physical Function scores did not, suggesting potential for longer term impact on quality of life. Clinical trial information: NCT01042379 . [Table: see text]

112: An”Early Adopter” of CPQR’s Patient Reported Outcome (PRO) Initiative: Lessons Learned Through Implementation of an Electronic PRO Platform Across a Mulit-Center Radiation Oncology Department

112: An”Early Adopter” of CPQR’s Patient Reported Outcome (PRO) Initiative: Lessons Learned Through Implementation of an Electronic PRO Platform Across a Mulit-Center Radiation Oncology Department

Utilization of an Electronic Patient-Reported Outcome Platform to Evaluate the Psychosocial and Quality-of-Life Experience Among a Community Sample of Ovarian Cancer Survivors.

Novel distress screening approaches using electronic patient-reported outcome (ePRO) measurements are critical for the provision of comprehensive quality community cancer care. Using an ePRO platform, the prevalence of psychosocial factors (distress, post-traumatic growth, resilience, and financial stress) affecting quality of life in ovarian cancer survivors (OCSs) was examined. A cross-sectional OCS sample from the National Ovarian Cancer Coalition-Illinois Chapter completed web-based clinical, sociodemographic, and psychosocial assessment using well-validated measures: Hospital Anxiety/Depression Scale-anxiety/depression, Post-traumatic Growth Inventory, Brief Resilience Scale, comprehensive score for financial toxicity, and Functional Assessment of Cancer Therapy-Ovarian (FACT-O/health-related quality of life [HRQOL]). Correlational analyses between variables were conducted. Fifty-eight percent (174 of 300) of OCS completed virtual assessment: median age 59 (range 32-83) years, 94.2% White, 60.3% married/in domestic partnership, 59.6% stage III-IV, 48.8% employed full-time/part-time, 55.2% had college/postgraduate education, 71.9% completed primary treatment, and median disease duration 6 (range < 1-34) years. On average, OCS endorsed normal levels of anxiety (mean ± standard deviation = 6.9 ± 3.8), depression (4.1 ± 3.6), mild total distress (10.9 ± 8.9), high post-traumatic growth (72.6 ± 21.5), normal resilience (3.7 ± 0.72), good FACT-O-HRQOL (112.6 ± 22.8), and mild financial stress (26 ± 10). Poor FACT-O emotional well-being was associated with greater participant distress (P < .001). Partial correlational analyses revealed negative correlations between FACT-O-HRQOL and anxiety (r = -0.65, P < .001), depression (r = -0.76, P < .001), and total distress (r = -0.92, P < .001). Yet, high FACT-O-HRQOL was positively correlated with post-traumatic coping (r = 0.27; P = .006) and resilience (r = 0.63; P < .001). ePRO assessment is feasible for identification of unique psychosocial factors, for example, financial toxicity and resilience, affecting HRQOL for OCS. Future investigation should explore large-scale, longitudinal ePRO assessment of the OCS psychosocial experience using innovative measures and community-based advocacy populations.

An innovative combination of cypropheptadine and prazosin for the treatment of alcohol use disorder: a double-blind, randomised, parallel-group, three-arm, multicentre, placebo-controlled phase 2 trial

IntroductionAnimal studies have shown that the simultaneous blockade of α1b-noradrenergic receptors and 5HT2A-serotonergic receptors strongly decreases alcohol intake. In addition, recent clinical studies have indicated that the selective α1b antagonist prazosin could be effective on alcohol use reduction in alcohol-dependent subjects.ObjectivesCocktail is a double-blind, randomised, parallel-group, three-arm, multicentre, placebo-controlled phase 2 proof-of-concept study aiming at demonstrating the superiority of a 12-week treatment with the KT110 combination of cyproheptadine (8 mg/day or 12 mg/day) and prazosin (5 mg/day or 10 mg/day) over placebo on the reduction of total alcohol consumption.MethodsThe study two main inclusion criteria are a DSM5 diagnosis of severe alcohol use disorder and a WHO high-risk drinking risk level. The primary endpoint is the change from baseline (4 weeks preceding randomization) to the end of treatment (Weeks 9-12) in the mean quantity of alcohol consumed per day in the three groups. Daily alcohol consumption is determined using the Timeline Follow Back, automatically be filled in on the basis electronic patient reported outcomes platform. The 12-week treatment period is followed by a 4-week post-treatment follow-up.ResultsOne hundred and eighty patients are planned to be randomized 1:1:1 into the two treatment groups. Enrollment of patients started in November 2019, and will end in July 2021.ConclusionsIn this communication, we will present the rationale for the development of the KT110 combination of cypropheptadine and prazosin for the treatment of alcohol use disorders, as well as the main features of the Coctkail study. ClinicalTrials.gov identifier: NCT04108104.DisclosureMember of advisory boards, DSMB, or steering committees, speaker honoraria or consultancy for Bioprojet, D&amp;A Pharma Ethypharm, and Kinnov Pharmaceuticals, Lundbeck, and Pfizer D&amp;A Pharma, Ethypharm, Kinnov Pharmaceuticals, Lundbeck, and Pfizer.

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.

Implementing Symptom Management Follow-up Using an Electronic Patient-Reported Outcome Platform in Outpatients With Advanced Cancer: Longitudinal Single-Center Prospective Study.

BackgroundPatients with cancer experience multiple symptoms related to cancer, cancer treatment, and the procedures involved in cancer care; however, many patients with pain, depression, and fatigue, especially those outside the hospital, receive inadequate treatment for their symptoms. Using an electronic patient-reported outcome (ePRO) platform to conduct symptom management follow-up in outpatients with advanced cancer could be a novel and potentially effective approach. However, empirical evidence describing in detail the preparation and implementation courses in a real setting is needed.ObjectiveThe purpose of this paper was to describe the implementation process and evaluation of an ePRO platform that facilitates symptom management for patients with cancer, share our experiences and the problems we encountered during the process of implementation, and share the solutions we identified for those problems. Moreover, we tested the feasibility, safety, and efficacy of the ePRO platform.MethodsThis was a real-world, ongoing, longitudinal, single-center, prospective study with a total of 7 follow-ups conducted within 4 weeks after the first visit to the symptom management clinic (on days 1, 3, 7, 10, 14, 21, and 28). Participants were encouraged to complete scales for physical symptoms (pain, fatigue, and shortness of breath), cognitive symptoms (memory problems and impaired concentration), and affective symptoms (especially depression and anxiety) during follow-up. The design and function of the ePRO-doctor client and ePRO-patient client, the patient-reported outcome (PRO) scales used in the study, and the strategies to promote symptom tracking have been described. Moreover, the training and evaluation for research assistants have been presented. The efficacy of the ePRO platform was assessed with a comparison of the baseline and 4-week outcomes on the MD Anderson Symptom Inventory.ResultsUsing the ePRO platform for symptom management follow-ups in advanced cancer patients was associated with a high completion rate (72.7%-86.4%) and a low drop-off rate (23.6%). The ePRO platform sent 293 alert notifications to both patients and doctors, which promoted patient security. The short and sharp PRO tool selection, user-friendly interface, automatic reminder notifications and alerts, and multiple dimensional training were essential components for the preparation and implementation of the ePRO system. The results showed significant improvements in the mean scores of pain, fatigue, and numbness from baseline to day 28 (P=.02, P=.02, and P<.001, respectively).ConclusionsThe use of an ePRO platform for symptom management follow-ups in advanced cancer patients is time-saving, energy-saving, and effective. PRO tool selection, platform design, and training of research assistants are important aspects for implementation. Future research should validate the ePRO platform in a larger randomized controlled study.

Hidradenitis Suppurativa International Online Community: Patient Characteristics and a Novel Model of Treatment Effectiveness.

Treatment for hidradenitis suppurativa is diverse, yet frequently unsatisfactory. The aims of this study were to create a reproducible artificial intelligence-based patient-reported outcome platform for evaluation of the clinical characteristics and comorbidities of patients with hidradenitis suppurativa, and to use this to grade treatment effectiveness. A retrospective patient-reported outcome study was conducted, based on online questionnaires completed by English-speaking patients registered to the hidradenitis suppurativa Stuff-ThatWorks® online community. Data collected included patient characteristics, comorbidities and treatment satisfaction. These were recoded into scalable labels using a combination of machine learning algorithm, manual coding and validation. A model of treatment effectiveness was generated. The cohort included 1,050 patients of mean ± standard deviation age 34.3 ± 10.3 years. Greater severity of hidradenitis suppurativa was associated with younger age at onset (p < 0.001) and male sex (p < 0.001). The most frequent comorbidities were depression (30%), anxiety (26.4%), and polycystic ovary syndrome (16.6%). Hurley stage I patients rated topical agents, dietary changes, turmeric, and pain relief measures more effective than tetracyclines. For Hurley stage II, adalimumab was rated most effective. For Hurley stage III, adalimumab, other biologic agents, systemic steroids, and surgical treatment were rated more effective than tetracyclines. Patients with hidradenitis suppurativa often have comorbid psychiatric and endocrine diseases. This model of treatment effectiveness provides a direct comparison of standard and complementary options.

The Effects of a Pandemic on Patient Engagement in a Patient-Reported Outcome Platform at Orthopaedic Sports Medicine Centers (106)

Objectives:Patient-reported outcomes (PROs) are an important clinical tool to effectively collect, compile, and assess patient data and clinical progress. Beyond just tracking patient progress, PROs facilitate patient-provider communication and can be used to inform care practices. Though recent studies have focused on the merits of PRO collection in orthopaedics, few have sought to understand the impact of the coronavirus pandemic on PRO collection. Our objective is to review the initialization of an electronic PRO collection platform at our Orthopaedic Sports Medicine clinics and surgery center before and during the coronavirus pandemic. We focus specifically on our first 7,557 patients in a retrospective study and the interplay between our collection tactics and the patients’ responses to PROs from November 2019 to July 2020.Methods:Starting in the fall of 2019, we implemented a new clinic-wide data capturing system to collect PROs and maintain our outcomes database. We began with a small group of providers and their patients before expanding to include most providers and staff in three clinics. Patients received the following forms prior to their first visit: Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference, PROMIS Physical Function, and subsequent corresponding anatomic-specific scales. The Brief Resilience Scale (BRS) was later added in the spring of 2020. A secure link to the surveys was sent to the patient’s email or phone prior to their appointment or accessed via an iPad at the clinic’s kiosk during their appointment. However, due to coronavirus cleaning protocols, forms were only sent to the patient’s email or phone beginning in March. Upon completion of July 2020 collection, we utilized STATA statistical software to analyze the data and identify trends in patient responses. For statistical analysis, we used chi-squared tests.Results:For the purpose of this study, we collected PROs from 7,557 patients between November 2019 and July 2020. After analyzing all data points in STATA, we determined differences in several collection categories, including the extent of completion and time of completion. Out of all patients prompted to complete one or more PROs, 37.20% of patients (n = 2811) did not complete any PROs, 11.86% of patients (n = 896) completed some but not all assigned PROs, and 50.95% of patients (n = 3850) completed all assigned PROs. Patients who completed all or some of their PROs completed them before their appointment 56.02% of the time (n = 2773), within an hour of their appointment 35.49% of the time (n = 1757), and after their appointment 8.48% of the time (n = 420) (see Figure 1).After separating PRO completion rates by month, we noticed a shift in compliance and patient response patterns before and during the coronavirus pandemic. From November to February, the average number of patients who completed one or more PROs was 80.20% (n = 1797) before dropping to an average of 57.74% (n = 5760; p <0.001) between March and July. The overall PRO compliance rate similarly dropped at our first PRO collection site, Clinic A, from an average of 86.75% to 76.81%, respectively (see Figure 2). Clinic operations were significantly reduced in late March due to the coronavirus pandemic, leading to majority telehealth visits and restrictions on clinic-wide shared iPad use. Though more than half of patients on average completed their PROs prior to their appointment throughout the year, this trend was especially prevalent during the coronavirus pandemic. For all or some PROs completed prior to appointment time, 42.34% were completed on average between November and February compared to 62.42% between March and July (see Figure 3).Beyond completion metrics, we observed a difference in appointment cancellations before and during the coronavirus pandemic. From November to February, 21.28% of patient appointments were canceled on average compared to 35.74% of appointments canceled on average from March to July. The number of cancelations during the coronavirus pandemic was significantly different than before the pandemic (p <0.001).Conclusions:In a short period of time (9 months) after initial implementation of a PRO platform, our practice has amassed significant data and reported outcomes for over 7,000 patients. Prior to the coronavirus pandemic, patients were relatively receptive to the new PRO collection platform with over 80% of patients completing some or all assigned PROs. However, following our clinic-wide cessation of shared iPads due to coronavirus concerns, we noted a significant decrease in our patient compliance (80.20% down to 57.74%; p <0.001). Though discontinuation of iPad and kiosk use likely only contributed in part to this significant decrease, this observation still suggests that shared devices may play an important role in promoting PRO compliance within the clinic.It’s also important to note the limitations in this study, including the staggered integration of each provider’s patients. This likely impacted the increased compliance rates in November with 282 patients versus 1677 patients in July. In addition, compliance may have been affected by the transition from two research staff members helping collect PROs to one research staff member. Methods of promoting compliance also changed as we shifted to telehealth visits. In March and April, members of our research team called patients about their incomplete PROs, likely prompting increased responses prior to patient appointments. We are utilizing these observations to improve our workflow for collecting patient PROs and increase compliance within the clinic. After reflecting on our initial findings, we feel the use of devices in clinic and full staff involvement can bolster completion of PROs and are important tools in order to best maintain a data collection platform with high patient compliance.

Leveraging patient-reported outcomes (PROs) in patients with pancreatic cancer: The Pancreatic Cancer Action Network (PanCAN) online patient registry experience.

BackgroundThe Pancreatic Cancer Action Network (PanCAN) Patient Registry is an online, pancreatic cancer‐specific, global registry enabling patients to self‐report sociodemographics, disease/management characteristics, and patient‐reported outcomes (PROs). We sought to describe the creation, user experience, and research potential of the PanCAN Registry.MethodsWe obtained data to describe (1) the creation of the Registry (questionnaire development, marketing efforts, and regulatory considerations); (2) the user experience (user characteristics and interactions with the registry following inception); and (3) the research potential of the registry (comparing PROs and treatment patterns by age [±65 years] and treatment site [community or academic] for users with de novo metastatic disease).ResultsThe Registry was conceived as part of PanCAN’s strategic plan for a personalized therapy initiative. PanCAN staff and disease expert consultants developed questionnaires hosted on an electronic PRO platform. Users had the option to include their data in research efforts, and the Registry platform received institutional review board approval. From 7/2015 to 12/2020, 2187 patients visited the registry and 1697 (77.6%) completed at least one survey (median age = 64 years [range: 24–90], 47.9% women, 88.7% White, 34.0% metastatic disease). Among patients with metastatic disease (N = 567), 46.0% were ≥65 years old and 67.5% received treatment at community sites. Patients ≥65 years reported feeling less hopeful about the treatment plan (12.4% vs. 24.3%, p = 0.003), and patients treated at community sites reported more frequent treatment breaks of >2 weeks (58.2% vs. 28.1%, p < 0.001).ConclusionsOur findings demonstrate the feasibility, usability, and research potential of an online PRO registry for patients with cancer. This description of the PanCAN Registry should inform future registry‐building efforts to facilitate standardized PRO reporting and provide a valuable research database. Clinical trial registration number: Not applicable.

POS1473-HPR SELF- AND SHARED-MANAGEMENT INTERVENTIONS FOR CHILDREN, YOUNG PEOPLE, AND FAMILIES LIVING WITH RHEUMATIC AND MUSCULOSKELETAL DISEASES: AN INTEGRATIVE REVIEW

Background:Self-management refers to the manner in which individuals manage the symptoms, treatment, physical and psychosocial impact of long-term conditions (LTCs). The importance of equipping children and young people living with LTCs, like rheumatic and musculoskeletal diseases (RMDs) with the capacity to self-manage is increasingly recognised in the literature, and in conversation. In addition, there is a strong case to support families who assume a shared-management role for their child. However, there is a limited understanding of interventions designed to improve self- and shared-management capacity in this population, prompting for a review of the literature, across multiple study designs.Objectives:The aim of this integrative review was to identify and describe interventions promoting self-management of RMDs by children and young people, and shared-management of RMDs by families.Methods:The integrative review followed a six-stage process [1]. Studies published since 2010 were identified through a search of eight bibliographic databases. Studies reporting on any paediatric-onset RMD were included, as were those in multiple condition areas where RMDs were included in the analysis. Twenty-six articles met the inclusion criteria: 24 research articles reporting on 17 interventions, and two review articles containing a further four research articles. The methodological quality of included articles was assessed using the Mixed Methods Appraisal Tool, and a thematic synthesis was undertaken.Results:Most study participants were CYP and families living with JIA. A minority of studies included CYP and families living with other RMDs, as well as chronic pain, type 1 diabetes mellitus, epilepsy, sleeping disorder, and cancer. Around half of the articles reported a specific theory and/or model or framework guiding the intervention. Interventions tended to be focussed at either CYP or families, with few designed to span the lifecourse from birth to young adulthood, while supporting all members of the family unit. Intervention types included: decisional aids; comic educational book; family retreat weekend; internet- and group-based cognitive behavioural programme; internet-based peer mentoring intervention; internet-based self-guided self-management intervention with weekly social support; internet-based electronic patient-reported outcome platform; smartphone applications; telenursing intervention; therapeutic recreational camp; therapeutic family nursing conversations; transition programme/clinic; and video games-based task-orientated activity training.Conclusion:This integrative review identified a range of interventions that have been evaluated to promote self- and shared management of RMDs by CYP and their families. There is a noticeable lack of emphasis on targeting the whole lifecourse for CYP, as well as supporting both CYP and families as they manage their RMD. Further work is needed to explore the underlying mechanisms which dictate how self- and shared-management interventions influence outcomes for CYP and families, under differing contexts, since this was overlooked by the majority of included studies.

A Novel Digital Patient-Reported Outcome Platform (Noona) for Clinical Use in Patients With Cancer: Pilot Study Assessing Suitability.

BackgroundAs the incidence of cancer is on the rise, there is a need to develop modern communication tools between patients and the medical personnel. Electronic patient-reported outcome (ePRO) measures increase the safety of cancer treatments and may have an impact on treatment outcome as well. ePRO may also provide a cost-efficient way to organize follow-up for patients with cancer. Noona is an internet-based system for patients to self-report symptoms and adverse events of cancer treatments from home via a computer or a smart device (eg, smartphone, tablet).ObjectiveIn this pilot study, we assessed the suitability of a novel ePRO application (Noona) for patients with cancer, nurses, and doctors at the Helsinki University Hospital, Finland.MethodsThe study included 44 patients with cancer (different solid tumor types) and 17 health care professionals (nurses or medical doctors). Patients were either operated or received systemic treatment or radiotherapy. Patients reported their symptoms to the medical staff via Noona. In addition, patients and clinicians answered a questionnaire, based on which Noona’s suitability for clinical use was evaluated in terms of usability (ease of use, operability, and learnability), reliability (subjective opinion of the participant), and incidence of harmful events reported by the participants.ResultsA total of 41/44 (93%) patients and 15/17 (88%) professionals reported that the program was easy or quite easy to use; 38/44 (86%) patients and 11/17 (65%) professionals found Noona reliable, and 38/44 (86%) patients and 10/17 (59%) professionals would recommend Noona to other patients or their colleagues. No harmful incidences caused by the use of Noona were reported by the patients; however, 1 harmful incidence was reported by one of the professionals.ConclusionsThe majority of the participants felt that Noona appeared reliable and it was easy to use. Noona seems to be a useful tool for monitoring patient’s symptoms during cancer therapy. Future studies will determine the impact of this ePRO platform in routine clinical practice.

Vision-Targeted Health-Related Quality-of-Life Survey for Evaluating Minimally Invasive Glaucoma Surgery

To develop a vision-targeted health-related quality-of-life instrument for patients with glaucoma who are candidates for minimally invasive glaucoma surgery (MIGS). Development of a health-related quality-of-life instrument. Twelve practicing ophthalmologists and 41 glaucoma patients. A questionnaire was constructed to assess functional limitations, vision-related symptoms, aesthetics, psychosocial issues, and surgical satisfaction for MIGS candidates. Questions were drafted after a review of the literature and subsequently refined based upon input from 1 physician and 4 patient focus groups. Nineteen cognitive interviews were used to ensure that questions were understandable to respondents. The focus group identified the following key issues and concerns as being important to glaucoma patients: functional limitations (eg, driving), bodily discomfort (eg, stinging from drops), changes in appearance (eg, drooping eyelid), and psychosocial concerns (eg, mental burden associated with a diagnosis of glaucoma, financial burden of treatment). Cognitive interviews resulted in the following improvements to the questionnaire: changes in wording to clarify lighting conditions, and additional questions addressing psychosocial issues, such as job loss, severity of disease, and perception of MIGS. A patient-reported outcomes instrument, the Glaucoma Outcomes Survey, was developed to evaluate MIGS for patients with mild to moderate glaucoma. Next steps include electronic administration to patients selected from the American Academy of Ophthalmology Intelligent Research in Sight (IRIS) registry. An electronic patient-reported outcomes platform will be used to administer the questionnaire before and after MIGS. The questionnaire will improve understanding of how surgical interventions such as MIGS impact vision-targeted health-related quality-of-life in glaucoma patients.

Nurse navigators' telemonitoring for cancer patients with COVID-19: a French case study.

PurposeThe Gustave Roussy Cancer Institute implemented a patient-reported outcome platform (CAPRI-COVID) for cancer patients with coronavirus disease 2019 (COVID-19) to quarantine patients at home while ensuring monitoring of COVID-related symptoms and securing the care pathway. In this study, we described the CAPRI-COVID intervention, evaluated its use, and presented results of the tracking indicators with a focus on the nurse navigators’ (NNs) activities and the experience of patients.MethodsData of 130 cancer patients with COVID-19 diagnosed from March 23 to June 5, 2020, were collected. Six COVID-related symptoms were monitored daily, either by the patient via the CAPRI mobile application (CAPRI App) or by NNs via telemonitoring. In the cases of worsening or new-onset symptoms, an automated alert was sent to the platform, and NNs could immediately consult an emergency physician for future course of action.ResultsAll 130 patients (median age: 59 years; 59.2% female) were monitored during the study period. There were no deaths or admissions to the intensive care unit attributable to COVID-19; 7.8% of patients were hospitalized (excluding scheduled hospitalization), and 17.1% were admitted to the emergency department at least once during the monitoring period. NNs carried out 1412 regular monitoring calls (average of 10.9 calls per patient), while 55% of the patients downloaded the CAPRI App.ConclusionsMost patients monitored with CAPRI-COVID were quarantined during the first wave of the pandemic. In addition to the CAPRI App, which helped limit phone calls, NNs played an essential role in patient management.

Stakeholder Development of an Online Program to Track Arthritis-Related Patient-Reported Outcomes Longitudinally: Live Yes! INSIGHTS.

ABSTRACTObjectivePatient‐reported outcome measures (PROMs) are increasingly used in clinical settings but may not provide benefits to patients outside of health encounters. The Arthritis Foundation’s Live Yes! Network provides an opportunity for PROM use by individuals and the network that assists individuals with managing their arthritis between encounters. Our objective was to develop a patient‐reported outcomes platform for the network, Live Yes! INSIGHTS, using mixed methods and extensive stakeholder input.MethodsA mixed methods longitudinal transformation design was used, starting with semistructured interviews to specify the main priorities of the program, literature review to identify potential PROMs, modified Delphi and nominal group technique to select final PROMs, and focus groups to guide program implementation, messaging, and use of results. We gathered input from 93 participants, including from individuals living with arthritis (74% of participants), caregivers, providers, researchers, and measurement experts.ResultsOur mixed methods study resulted in the selection of Patient‐Reported Outcomes Measurement Information System (PROMIS)‐29, PROMIS Emotional Support Short Form v2.0, and the Health Care Empowerment Questionnaire, to be deployed through a Qualtrics platform. Triangulation of data resulted in identification of potential risks and benefits, including confidentiality, ability to personally track and share data, and an opportunity to contribute to research.ConclusionAn accessible measurement system backed by psychometrically strong PROMs, created with robust stakeholder engagement, and linked to a national patient network sets the stage for individuals with arthritis to better monitor and improve health outcomes both outside and inside health care settings and for the network to customize programming to meet needs.

Feasibility and design of a cloud-based digital platform in patients with advanced cancer.

211 Background: Patient reported outcomes (PROs) allow for systematic and more continuous capture of the patient experience. PROs have been associated with improved symptom management and quality of life in patients with advanced cancer; however how to do this in a real world setting is not thoroughly described. We sought to provide a description of the implementation and feasibility of a digital PRO application in patients with advanced cancer at one academic center. Methods: This is an ongoing randomized trial, comparing digital PRO intervention vs standard of care, in advanced cancer patients from three oncology groups (thoracic, gastrointestinal, genitourinary). Prior to trial initiation, a lead in period to test workflows was conducted, as well as key stakeholder interviews to optimize engagement with the platform. Clinical team members (e.g. nurses, advanced practice providers) were critical to the workflows developed, thus operational leadership buy-in was required. We were unable to integrate our PRO platform with our digital EHR. Regular sponsor meetings addressed technical concerns and patient/provider feedback. Processes were tailored for each disease group to handle varying degrees of symptoms (mild, moderate and severe). Patient and clinician satisfaction and qualitative feedback was collected. We defined feasibility as &gt; 70% questionnaire completion on the platform. Results: There are 64 patients on the intervention arm and 64 on the control arm. Of eligible patients, 93% (128/138) enrolled in the study. During the study period, 447 digital symptom questionnaires were sent by the platform, of which 333 were completed (74%). The majority of clinicians (82%, n = 18) and patients (85%, n = 64) felt neutral or positive when asked if the tool was easy to use. Approximately half of clinicians (45%, n = 10) and patients (46%, n = 36) would probably or definitely recommend the platform. Conclusions: Web-based PRO reporting for patients with advanced cancer is feasible. Clinicians and patients found the platform both acceptable and easy to use. Future directions include integration with our EHR, expansion across disease groups and other centers, and creation of workflows that are integrated into routine clinical practice.

A digital oncology patient-reported outcomes platform: Building innovative electronic patient symptom assessments in epic mychart to improve the quality of life and survival of patients with advanced cancer.

e18312 Background: Establishing a system to monitor patient reported outcomes (“PRO”) has been demonstrated to be essential for a well-functioning cancer system. Studies have shown that routine collection of PROs allows providers to address medical issues earlier and impacts a patient’s overall survival. Unmet needs for symptom management are prevalent in the cancer population, especially patients with advanced cancer. Approximately 35% of UCLA Hematology-Oncology patients with advanced cancer in 2016 presented to Emergency Rooms for symptom-related complaints such as nausea, pain, constipation, dehydration, and fatigue. We hypothesize that the creation of an electronic PRO platform through EPIC MyChart will ensure patients receive timely evaluation of their symptoms, resulting in improved quality of life, and decreased ER and hospital utilization. Methods: We developed an innovative PRO platform through Epic MyChart along with a Best Practice Advisory alert system to identify patients at risk for worsening symptoms, ER visits, and inpatient admissions. We then built an electronic version of the Edmonson Symptoms Assessment System, which providers can push to patients through Epic MyChart, with results stored within the Flowsheets section of Epic. We also built a passive alert using Epic’s Best Practice Advisory (“BPA”) system, to notify providers when a patient’s MyChart ESAS Assessment Scores have exceeded a defined threshold. Results: Preliminary data from surveys sent to a series of advanced cancer patients seen in an outpatient palliative oncology clinic over 1 month, demonstrated a 100% response rate (6/7) surveys completed when sent one week prior to patient’s being seeing in clinic, and 17% response rate (1/6) when sent two to three weeks prior to clinic visit. The average total ESAS score reported was 40, with average individual score of 4/10 for any given symptom. Conclusions: We will implement this electronic PRO platform in multiple oncology clinics at UCLA, and measure provider and patient satisfaction, completion rates, and monitor outcomes such as ED visits and inpatient admissions. We hope this system will lead to an overall survival benefit. This project demonstrates the potential of developing innovative PRO platforms through Epic MyChart and the importance of clinical workflows in the implementation process.

Barriers to widespread implementation of patient-reported outcome platforms for cancer patients.

107 Background: Patient-reported outcome (PRO) platforms for cancer patients have shown to be effective in improving overall survival, quality of life, and adherence to medication in studies. However, due to controlled environments and limited regional scope, they do not shed light on the barriers for widespread PRO implementation. This study aims to identify such barriers by studying user demographics and usage patterns of an existing free Brazilian PRO mobile app. Methods: From Dec. 2016 to Jul. 2018, 1,246 cancer patients voluntarily registered on the mobile app downloadable on Google Play Store. Patients could report symptoms, physical activity, hours of sleep, weight, fever, overall well-being, and reasons for gratitude on the app. Other features included alarms for medications and a record of patients' hospitals and medical staff. Data collected by the app were analyzed for primary outcomes of user demographics and app usage patterns. Results: Out of the 1,246 registered patients, 44.1% were between the ages of 20 and 49 while only 11.3% were over the age of 65. Half of the patients never logged symptoms, and only 3.2% recorded symptoms more than 10 times. Physical activity, hours of sleep, and weight were each reported by less than 2% of patients. Surprisingly, 37.7% of patients recorded reasons for gratitude a mean of 3.2 times (SD = 10.3), more than the mean 2.9 times (SD = 8.6) that patients reported symptoms. Reporting overall well-being was the most used feature with 50.3% of patients having used it at least once with a mean of 3.9 times (SD = 17.2). Conclusions: Compared to closed short-term small-scale studies, patients engaged significantly less with the unrestricted open-access PRO platform, in particular geriatric patients. This is a significant barrier to widespread implementation as PRO's efficacy relies on consistent patient reports, and as cancer is more common among the elderly. These issues may be due to lack of guidance and supervision from medical/non-medical staff, absence of education on PRO's purpose, or access to technology caused by regional cultural differences. Further research on the cause of and solution for low patient engagement is needed for successful implementation in less-guided environments.

Development of the KOOSglobal Platform to Measure Patient-Reported Outcomes After Anterior Cruciate Ligament Reconstruction

Background: The Knee injury and Osteoarthritis Outcome Score (KOOS) has demonstrated inferior psychometric properties when compared with the International Knee Documentation Committee (IKDC) subjective knee form when assessing outcomes after anterior cruciate ligament (ACL) reconstruction. The KOOS, Joint Replacement (KOOS, JR) is a validated short-form instrument to assess patient-reported outcomes (PROs) after knee arthroplasty, and the purpose of this study was to determine if augmenting the KOOS, JR with additional KOOS items would allow for the creation of a short-form KOOS-based global knee score for patients undergoing ACL reconstruction, with psychometric properties similar to those of the IKDC. Hypothesis: An augmented version of the KOOS, JR could be created that would demonstrate convergent validity with the IKDC but avoid the ceiling effects and limitations previously noted with several of the KOOS subscales. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: Based on preoperative and 2-year postoperative responses to the KOOS questionnaires from a sample of 1904 patients undergoing ACL reconstruction, an aggregate score combining the KOOS, JR and the 4 KOOS Quality of Life subscale questions, termed the KOOSglobal, was developed. Psychometric properties of the KOOSglobal were then compared with those of the IKDC subjective score. Convergent validity between the KOOSglobal and IKDC was assessed with a Spearman correlation (ρ). Responsiveness of the 2 instruments was assessed by calculating the pre- to postoperative effect size and relative efficiency. Finally, the presence of a preoperative floor or postoperative ceiling effect was defined with the threshold of 15% of patients reporting either the worst possible (0 for KOOSglobal and IKDC) or the best possible (100 for KOOSglobal and IKDC) scores, respectively. Results: The newly developed KOOSglobal was responsive after ACL reconstruction and demonstrated convergent validity with the IKDC. The KOOSglobal significantly correlated with the IKDC scores (ρ = 0.91, P < .001), explained 83% of the variability in IKDC scores, and was similarly responsive (relative efficiency = 0.63). While there was a higher rate of perfect postoperative scores with the KOOSglobal (213 of 1904, 11%) than with the IKDC (6%), the KOOSglobal was still below the 15% ceiling effect threshold. Conclusion: The large ceiling effects limit the ability to use several of the KOOS subscales with the younger, more active ACL population. However, by creating an aggregate score from the KOOS, JR and 4 KOOS Quality of Life subscale questions, the 11-item KOOSglobal offers a responsive PRO tool after ACL reconstruction that converges with the information captured with the IKDC. Also, by offering the ability to calculate multiple scores from a single questionnaire, the KOOSglobal may provide the orthopaedic community a single PRO platform to be used across knee-related subspecialties. Registration: NCT00478894 (ClinicalTrials.gov identifier).

Development of the HOOSglobal to Assess Patient-Reported Outcomes in Patients Undergoing Hip Preservation Procedures

Background: The creation of a single patient-reported outcome (PRO) platform validated across hip preservation, osteoarthritis (OA), and total hip arthroplasty (THA) populations may reduce barriers and streamline the routine collection of PROs in clinical practice. As such, the purpose of this study was to determine if augmenting the Hip disability and Osteoarthritis Outcome Score–Joint Replacement (HOOS, JR) with additional HOOS questions would result in a PRO platform that could be used across a wider spectrum of hip patient populations. Hypothesis: The HOOS, JR would demonstrate a notable ceiling effect, but by augmenting the HOOS, JR with additional HOOS questions, a responsive PRO platform could be created. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: Using preoperative and postoperative HOOS responses from a sample of 304 patients undergoing periacetabular osteotomy (PAO), additional items were identified to augment the HOOS, JR. The psychometric properties of a newly created PRO tool (HOOSglobal) were then compared with the HOOS, JR and other PRO instruments developed for patients with hip OA and/or undergoing THA. Results: By augmenting the HOOS, JR with 2 additional questions, the HOOSglobal was more responsive than all other included PRO tools and had significantly fewer maximum postoperative scores than the HOOS, JR (P < .0001), HOOS–Physical Function Short form (P < .0001), Western Ontario and McMaster Universities Osteoarthritis Index (P = .02), University of California, Los Angeles activity scale (P = .0002), and modified Harris Hip Score (P = .04). The postoperative HOOSglobal score threshold associated with patients achieving the patient acceptable symptom state (PASS) was 62.5. Conclusion: The HOOSglobal is a valid and responsive PRO tool after PAO and may potentially provide the orthopaedic community with a PRO platform to be used across hip-related subspecialties. For patients undergoing PAO, a postoperative HOOSglobal score ≥62.5 was associated with patients achieving the PASS.