Collection Of Patient-reported Outcomes Research Articles

Poster 194: Recall Bias in the Retrospective Collection of Common Pre-Operative Patient-Reported Outcome Measures in Hip Arthroscopy

Objectives:To assess for the presence of recall bias between prospectively and retrospectively collected patient-reported outcome (PRO) scores in hip arthroscopy (HA).Methods:Patients that underwent HA between 2015-2021 and provided pre-operative baseline responses for the International Hip Outcome Tool-12 (iHOT-12), the Hip Disability and Osteoarthritis Outcome Score Physical Shortform (HOOS-PS), and the modified Harris Hip Score (mHHS) were eligible for recruitment. Eligible participants were asked to complete a study-specific survey and the same preoperative PROs retrospectively, requiring them to recall the status of the hip prior to surgery. Agreement between the prospective and retrospective scores was assessed using a two-way mixed effects intraclass coefficient (ICC) model. Paired t-tests were used to compare the mean scores of both groups and linear regression models were used to help identify associations between score discrepancies and patient characteristics.Results:A total of 222 patients were approached for participation, of whom 104 (60.6% female) completed study requirements and were included for analysis. The mean duration of symptoms before surgery was 24.5 ± 31.8 months and the mean duration to recall (from the day of surgery) for the retrospective completion of hip surveys was 29.1 ± 21.8 months. The iHOT-12 had a low amount of agreement between prospective and retrospectively collected scores (ICC=.452; P =.000). HOOS-PS scores also had a low amount of agreement (ICC=.458; P =.000). The mHHS had a moderate amount of agreement (ICC=.621; P =.000). Mean scores for iHOT-12 (41.5 ± 22.6 vs. 35.3 ± 17.7; P <.01), HOOS-PS (29.5 ± 18.9 vs 40.7 ± 17.9; P <.001), and mHHS (62.9 ± 16.5 vs 55.1 ± 15.3; P <.001) were all significantly different prospectively vs. retrospectively. The average changes in score observed for the iHOT-12, HOOS-PS, and mHHS were -6.2, 11.2, and -7.8, respectively. Multiple linear regression identified duration to recall and sex as significant predictors of the absolute difference between prospective and retrospectively collected iHOT-12 data while sex alone was predictive of a difference in HOOS-PS data.Conclusions:The retrospective collection of patient-reported outcomes for hip arthroscopy procedures, which requires patient recall of their preoperative condition, is subject to bias and inaccuracy. Recalled PROs consistently reflected worse pain/function than their prospectively recorded counterpoints; therefore, retrospective patient recall is an unreliable source of clinical data and the prospective collection of iHOT-12, mHHS, and HOOS-PS data should be prioritized.Figure 1.The mean scores of the three PROs collected prospectively and retrospectively. The mean changes in score for the iHOT-12, HOOS-PS, and mHHS were -6.2, 11.2, and -7.8, respectively. Note that a lower score on the iHOT-12 and mHHS axis indicates worse function/most pain while a lower score on the HOOS-PS axis indicates better hip condition.Figure 2.Scatterplot demonstrating the relationship between the prospectively collected PROs and recalled (retrospective) PROs for the iHOT-12, HOOS-PS and mHHS surveys. Points falling outside the areas bound by the parallel lines represent patients with recall scores that differ from preoperative scores to a greater extent than the minimal clinically important difference (MCID). Note that the currently accepted HOOS MCID (9.1 points) was used in the middle frame in lieu of a HOOS-PS MCID as no such value has been established.Table 1.A summary of patient demographics stratified by patient-reported outcome.

Bridging New Technology Into Clinical Practice With Mobile Apps, Electronic Patient-Reported Outcomes, and Wearables.

With sophisticated mobile and wearable technologies available, there has been interest in leveraging these devices to help gather and analyze patient-generated health data (PGHD). This information could be used to better address health concerns, aid in treatment decision-making, and guide interventional strategies to improve outcomes. Among PGHD, electronic patient-reported outcomes, direct reports of patient experience usually collected via validated scales and questionnaires, are increasingly integrated into routine clinical practice to monitor patient status. Electronic patient-reported outcomes have been shown to improve outcomes, including symptom control, quality of life, and overall survival, in several clinical trials. Electronic patient-reported outcome collection is now being implemented across broader clinical practice settings but with limited evaluation of impact thus far. Wearable devices and mobile apps provide opportunities to collect additional PGHD, including continuous physiologic measures, and to generate algorithms with which to monitor patients with cancer and guide interventions. In this article, we discuss several topics related to PGHD and technology, including electronic patient-reported outcomes, mobile apps, and wearable devices and how their introduction into oncology care has the potential to improve the collection and use of PGHD in the future. We also highlight the challenges and future directions needed for mobile and wearable technologies to provide meaningful information that can be acted upon and thus can improve oncologic care.

PCR167 At-Home Versus in-Clinic Patient Reported Outcome Compliance in Oncology Clinical Trials

There is increased regulatory emphasis on using patient reported outcomes (PROs) in oncology to provide additional information on clinical benefit beyond traditional survival and tumor response endpoints. Latest recommendations highlight core PROs to consider and the need for more frequent assessments for more accurate quality of life evaluation. To accommodate these recommendations, PRO collection is shifting from the clinic to patients’ homes to allow for more frequent data collection while reducing the burden of travel and site visit time. However, given disease progression characteristics, oncology studies are already at risk for low compliance, and unsupervised at-home PRO collection puts greater responsibility on patients. We aimed to determine the impact of at-home data collection on PRO compliance in oncology studies.

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.

Real-World Adherence to Patient-Reported Outcome Monitoring as a Cancer Care Quality Metric.

Routine collection of patient-reported outcomes (PROs) for patients with advanced solid malignancies is an evidence-based practice and critical component of high-quality cancer care, but real-world adherence is poorly characterized. We sought to describe real-world adherence to PRO monitoring and its potential predictors. We conducted a retrospective cross-sectional study using deidentified electronic health record data from a National Cancer Institute Cancer Center, encompassing one academic and two community sites. Participants included individuals with lung cancer receiving systemic therapy from January 1 to December 31, 2019. The primary outcome was patient-level adherence, defined as the proportion of treatment visits during which a PRO questionnaire (spanning symptoms, functional status, and global quality-of-life domains) was completed within 30 days. Practice-level performance was calculated as unadjusted mean patient-level adherence. We modeled patient-level adherence using multivariable ordinary least squares regression and identified covariates associated with adherence using a significance threshold of P < .05. In 2019, there were 18,604 encounters for 1,105 patients with lung cancer (mean [standard deviation] age 65.8 [10.2] years; 621 [56.2%] female; 216 [19.6%] Black) receiving systemic therapy. The mean patient-level PRO adherence ranged from 27.2% to 70.0% across sites and was 49.4% overall. Advanced age (≥ 65 years) and Black or African American race were negatively associated with PRO adherence (P < .01). Across this real-world cohort of patients undergoing treatment for lung cancer, adherence to PRO monitoring lagged that achieved in seminal clinical trials, with potential age- and race-based disparities, demonstrating an implementation gap that could be addressed with standardized reporting of an adherence-based quality metric.

Challenges in virtual collection of patient-reported data: a prospective cohort study conducted in COVID-19 era.

Prior to the COVID-19 pandemic, patients attending ambulatory clinics at cancer centers in Ontario completed the Edmonton Symptom Assessment Scale (ESAS) at each visit. At our center, completion was via touchpad, with assistance from clinic volunteers. As of March 2020, clinic appointments were conducted virtually when possible and touch pads removed. We anticipated a negative impact on the collection of patient-reported outcomes (PROs) and the recognition of severe symptoms.MethodsWe performed a prospective cross-sectional cohort study to investigate remote ESAS completion by patients with appointments at a weekly surgical oncology clinic. Patients in the initial study cohort were asked to complete and return the ESAS virtually (V). Given low completion rates, the ensuing cohort was asked to complete a hard-copy (HC) ESAS. For the final cohort, we provided remote, personal mentorship by a member of the care team to support virtual electronic ESAS completion (virtual-mentored (VM) cohort).ResultsBetween May and July 2020, a total of 174 patient encounters were included in the study. For the V cohort, 20/46 patients (44%) successfully completed and returned the electronic ESAS, compared to 49/50 (98%) for the HC cohort. For the VM cohort, the overall completion rate was 74% (58/78); however, 12 of these 58 patients did not independently complete a virtual ESAS. Virtual questionnaire completion was not predicted by age, sex, or tumor site, although patients who completed the ESAS were more likely to be in active management rather than surveillance (p = 0.04). Of all completed forms, 42% revealed a depression score of ≥2, and 27% an anxiety score of ≥4.ConclusionsWe identified significant barriers to the virtual completion of ESAS forms, with a lack of predictive variables. The severe degree of psychological distress reported by ~50% of respondents demonstrates the need for ongoing regular collection/review of these data. Innovative solutions are required to overcome barriers to the virtual collection of PROs.Supplementary InformationThe online version contains supplementary material available at 10.1007/s00520-022-07191-3.

Racial and ethnic disparities in adherence and reported symptoms during routine collection of patient-reported outcomes (PROs).

6510 Background: Routine collection of PROs for patients with cancer is an evidence-based practice and critical component of high-quality cancer care, but real-world adherence and reporting patterns are poorly understood. We examined differences in PRO adherence and reported symptoms by race and ethnicity. Methods: We conducted a retrospective cross-sectional study using de-identified electronic health record data from a National Cancer Institute Comprehensive Cancer Center. Participants included adults seen in follow-up at one of two medical oncology practices (1 academic, 1 community) from June 2019 to February 2020, during which two validated PRO instruments (NCI PRO-CTCAE and PROMIS Global v1.2) were routinely administered electronically via portal or tablet at return visits. Adherence was defined for each participant as the proportion of visits in which a PRO questionnaire was completed within 30 days. Using ordinary least squares regression, we modeled patient adherence as a function of race/ethnicity and adjusted for age, sex, insurance, median area income, ECOG performance status, cancer type, cancer stage, visit site, and number of visits during the study. Among study participants completing at least one PRO questionnaire, we modeled reported symptoms from the first questionnaire using a similar approach. Results: From June 2019 to February 2020, there were 29,726 patients (mean [SD] age 60.8 [15.1] years; 18,045 [60.7%] female) seen across 111,262 medical oncology visits. Of these patients, 19,971 (67.2%) completed at least one PRO questionnaire. Adjusted mean PRO adherence and reported symptoms varied by race/ethnicity, with Black and Hispanic patients reporting significantly higher symptom burden than White patients (Table). Conclusions: In this large cohort reflecting real-world PRO collection patterns, Black and Hispanic patients were less likely than White patients to complete PRO questionnaires, but more likely to report more severe symptoms. There is urgent need to ensure equitable PRO access and implementation and to address greater reported symptom burden among minority patients. [Table: see text]

P-153 Prospective collection of patient-reported outcomes in patients with locally advanced rectal cancer receiving modern radiotherapy

Neoadjuvant radiotherapy (RT) followed by total mesorectal excision is standard of care for locally advanced rectal cancer (LARC). Patient-reported outcome measures (PROM) are valuable for patient-centred information on side-effects and evidence-based recommendations – as patients might be willing to trade clinical advantages to maintain high quality of life (QoL). This study aims to report prospectively collected PROM after modern neoadjuvant radiotherapy for LARC.

Association between remotely-monitored activity, patient-reported outcomes, and physical function in patients with advanced pancreatic cancer.

1572 Background: Patients with pancreatic ductal adenocarcinoma (PDAC) experience significant functional decline over the course of their treatment, which can negatively impact their quality of life (QOL) and clinical outcomes. There are currently no standardized methods to monitor physical function (PF) in PDAC patients outside the clinic setting. The use of wearable technology to obtain continuous and objective activity data combined with routine collection of patient-reported outcomes (PROs) provides an opportunity to monitor PF and intervene in a timely matter. Methods: We conducted a single-site, single-arm prospective study in advanced stage 3 and 4 PDAC patients between 2019 and 2/2022. Patients used a wrist-worn wearable activity monitor (Fitbit) continuously for 8 weeks and completed NIH PROMIS surveys (PF, pain, fatigue, sleep disturbance, and emotional distress) at baseline, week 4 and week 8. ECOG performance status (PS), hand grip strength, and timed 15-foot walk test were also assessed at each timepoint. Pearson correlation coefficients were calculated for activity data (step counts, distance, stairs, time spent sedentary and in light, moderate, or vigorous activity, sleep), PROs, and functional outcomes. Multivariable regression models, adjusted for age, sex, and cancer stage, were fit to evaluate associations between activity metrics, PROs, and functional outcomes. Multivariable cox proportional hazard models were fit to evaluate the impact of activity levels on survival. Results: A total of 40 patients consented onto study: 50% female, median age: 67 years (range 47-85), 92% ECOG 1. Baseline activity data are summarized in Table. Statistically significant correlations between step counts and PF T-scores (coeff: 0.6, p = 0.001) and lower pain scores (coeff: -0.53, p = 0.002) were observed. Increased stairs count and time spent in moderate and high physical activity were also positively correlated with increased PF (p&lt;0.001). No statistically significant correlations were observed between hand grip strength, activity metrics or PROs. Fewer average step counts and worse PF scores were significantly associated with poor survival with hazard ratios (HR) of 1.44 per 1000 steps (95% CI 1.06, 1.97, p = 0.02) and 1.69 (95% CI 1.1-2.56, p = 0.017), respectively, after adjusting for age, sex, stage, and ECOG PS. Conclusions: Findings from this research suggest that the use of wearable technology for remote monitoring of daily activity is feasible and may be used to supplement functional assessment and predict outcomes in PDAC patients. Larger trials are needed to validate findings. [Table: see text]

How to Optimise the Collection of Patient-Reported Outcomes in the Context of a Specific Disease such as Eating Disorders

Background: Eating disorders (EDs) are severe psychiatric disorders which, when left untreated, can lead to psychosocial impairment, physical disability and death. In the United Kingdom, many specialist ED services collect routine outcome measures (ROMs) which serve to assess illness severity, patients’ quality of life and function. The repeated collection of ROMs over the course of treatment allows for the objective evaluation of patient progress towards recovery. Recent National Health Service (NHS) guidance on adult ED care in England suggests that all services should use ROMs, not just to track progress, but also to support the achievement of collaboratively identified, person-specific recovery goals, to empower patients and inform individualised treatment. To achieve this objective, clinicians need access to psychometrically sound ROMs which can be utilised in a collaborative and person-centred manner. Traditionally, ROMs have been collected using standardised patient-reported outcome measures (PROMs), but increasingly individualised PROMs (i-PROMs) are also being developed. Methods &amp; Findings: In this talk I will review the ‘why, what and how’ of ROMs, PROMs, I-PROMS and of associated normative and ipsative feedback on these measures in the eating disorders context. Conclusions: Use of PROMs has much to be commended both in regard to treating individual patients, at service level and also the wider health care system.DisclosureNo significant relationships.

Longitudinal Collection of Patient-Reported Outcomes and Activity Data during CAR-T Therapy: Feasibility, Acceptability, and Data Visualization.

Simple SummaryPatients treated with chimeric antigen receptor T-cell therapy (CAR-T) are at risk for severe toxicities post-treatment. Patient-reported outcomes and activity data from fitness trackers could be helpful for monitoring patients after CAR-T. The aim of this pilot study was to test the feasibility and acceptability of having patients complete surveys on a rigorous schedule and wear a Fitbit tracker continuously, from before their CAR-T infusion through 90-days post-infusion. In a sample of 12 patients with hematologic malignancies, we demonstrated feasibility and acceptability, with high rates of behavioral adherence to the study procedures. These findings suggest that large-scale data collection efforts using these procedures will be successful. In turn, patient-reported outcomes and activity data could be used to identify predictors of severe CAR-T-related toxicities.Background: Clinicians must closely monitor patients for toxicities after chimeric antigen receptor T-cell therapy (CAR-T). Patient-reported outcomes (PROs) (e.g., toxicities, quality of life) and activity data (e.g., steps, sleep) may complement clinicians’ observations. This study tested the feasibility and acceptability of collecting PROs and activity data from patients with hematologic malignancies during CAR-T and explored preliminary data patterns. Methods: Participants wore a Fitbit tracker and completed PROs at several timepoints through 90-days post-infusion. Feasibility was assessed with a priori benchmarks for recruitment (≥50%), retention (≥70%), PRO completion (≥70%), and days wearing the Fitbit (≥50%). Acceptability was assessed with participant satisfaction (a priori benchmark > 2 on a 0–4 scale). Results: Participants (N = 12) were M = 66 years old (SD = 7). Rates of recruitment (68%), retention (83%), PRO completion (85%), and days wearing the Fitbit (85%) indicated feasibility. Satisfaction with completing the PROs (M = 3.2, SD = 0.5) and wearing the Fitbit (M = 2.9, SD = 0.5) indicated acceptability. Preliminary data patterns suggested that participants with better treatment response (vs. progressive disease) had a higher toxicity burden. Conclusions: Longitudinal PRO and activity data collection was feasible and acceptable. Data collected on a larger scale may be used to specify risk prediction models to identify predictors of severe CAR-T-related toxicities and inform early interventions.

Striving to Fill in Gaps between Clinical Practice and Standards: The Evolution of a Pan-Canadian Approach to Patient-Reported Outcomes Use.

Despite the known importance and necessity of the standardized collection and use of patient-reported outcomes (PROs), there remain challenges to successful clinical implementation. Facilitated through a quality improvement initiative spearheaded by the Canadian Partnership for Quality Radiotherapy (CPQR), and now guided by the Canadian Association of Radiation Oncology (CARO)’s Quality and Standards Committee, patient representatives and early-adopter radiation treatment programs continue to champion the expansion of PROs initiatives across the country. The current review discusses the evolution of a pan-Canadian approach to PROs use, striving to fill in gaps between clinical practice and guideline recommendations through multi-centre and multidisciplinary collaboration.

Defining a Standard Set of Patient-Reported Outcomes for Patients With Advanced Ovarian Cancer.

PurposeAdvanced ovarian cancer (AOC) and its treatment cause several symptoms and impact on patients’ health-related quality of life (HRQoL). We aim to reach a consensus on the most relevant patient-reported outcome (PROs), the corresponding measures (PROMs), and measurement frequency during AOC patients’ follow-up from patients’ and healthcare professionals’ (HCP) perspective.MethodsThe project comprised five steps: 1) a literature review, 2) a focus group with patients, 3) a nominal group with HCP, 4) two round-Delphi consultations with patients and HCP, and 5) a final meeting with HCP. Delphi questionnaire was elaborated based on literature review, focus group (n=5 patients), and nominal group (n=16 HCP). The relevance of each PRO and the appropriateness (A) and feasibility (F) of the proposed PROM were assessed (Likert scale 1=strongly agree; 9=strongly disagree). The consensus was reached when at least 75% of the panelists rated it as ‘relevant’, ‘appropriate’, or ‘feasible’ (score 7-9).ResultsA total of 56 HCP [51.8% Hospital Pharmacy; 41.1% Oncology; 3.6% Nursing; and 3.6% Psycho-oncology; mean time in specialty 12.5 (8.0) years] and 10 AOC patients [mean time diagnosis 5.4 (3.0) years] participated in the 1st round. All PROs achieved consensus regarding their relevance, except dry skin (58.0%). Agreement was reached for PRO-CTCAE to be used to assess fatigue (A:84.9%; F:75.8%), neuropathy (A:92.4%; F:77.3%), diarrhea (A:87.9%; F:88.7%), constipation (A:86.4%; F:75.8%), nausea (A:89.4%; F:75.8%), insomnia (A:81.8%; F:88.7%), abdominal bloating (A:82.2%; F:82.2%) and sexuality (A:78.8%; F:88.6%); EQ-5D to determine patients’ HRQoL (A:87.9%; F:80.3%), pain (A:87.9%; F:75.8%) and mood (A:77.7%; F:85.5%); to assess treatment adherence the Morisky-Green (A:90.9%; F:84.9%) and the dispensing register (A:80.3%; F:80.3%) were chosen. It was agreed to note in the medical record whether the patient’s treatment preferences had been considered during decision-making (A:78.8%; F:78.8%) and to use a 5-point Likert scale to assess treatment satisfaction (A:86.4%; F:86.4%). Panelists agreed (A:92.4%; F: 77.3%) to collect these PROs (1) at the time of diagnosis/relapse; (2) one month after starting treatment/change therapeutic strategy; (3) every three months during the 1st-year of treatment; and later (4) every six months until treatment completion/change.ConclusionsThe consensus reached represents the first step towards including the patient’s perspective in AOC follow-up. The standardized collection of PROs in clinical practice may contribute to optimizing the follow-up of these patients and thus improving the quality of care.

Patient-reported outcome measures after thrombectomy in patients with acute stroke: fine-tuning the modified Rankin Scale

BackgroundIn patients with stroke undergoing endovascular treatment (EVT), long-term outcome is usually only evaluated by the modified Rankin Scale (mRS). Patient-reported outcomes (PROMs) are standardized assessments that consider clinical outcomes...

MO901: Longitudinal Pruritus Assessment in Hemodialysis Patients: 1-Year Course of Symptoms and Associations With Clinical and Patient-Reported Outcomes

Abstract BACKGROUND AND AIMS The burden of chronic kidney disease-associated pruritus (CKD-aP) in hemodialysis (HD) patients, and its association with adverse clinical events and patient-reported outcomes (PROs) has been well-established. However, most studies focus on a single baseline CKD-aP assessment. In this study, we quantify the extent to which pruritus symptoms vary &amp;gt;1 year, and relationship with associated clinical and patient-reported outcomes. METHOD We included 7976 HD patients across 21 countries in the Dialysis Outcomes and Practice Patterns Study (DOPPS) phases 4–6 (2009–18) who had 2 CKD-aP assessments 12 months (±6 months) apart, with concurrent PRO collection. CKD-aP intensity was assessed by a single question in the KDQOL-36 asking about the extent patients were bothered by itch over the past 4 weeks. We categorized patients into 4 groups—those at least moderately (versus somewhat or not at all) bothered by itchy skin in Year 1 only (Yes/No), Year 2 only (No/Yes), neither (No/No), or both (Yes/Yes) time points. Difference-in-difference analyses were used to estimate changes in laboratory values and PROs between Years 1 and 2, by within-patient changes in CKD-aP severity. Cox regression was used to estimate rates of mortality and hospitalization, with follow-up starting after the Year 2 CKD-aP assessment, across the 4 exposure groups, adjusted for confounders. RESULTS Half of the patients were at least moderately bothered by pruritus over the course of 1 year: 22% of patients were at least moderately bothered by CKD-aP at each annual assessment (Yes/Yes); 14% each were bothered at Year 1 only (Yes/No) or Year 2 only (No/Yes); 49% were not bothered at either CKD-aP assessment (No/No). These proportions were similar across DOPPS regions. Changes in laboratory values—including calcium, phosphorus, parathyroid hormone (PTH), albumin, hemoglobin, single pool Kt/V—between Years 1 and 2 varied minimally by within-patient changes in CKD-aP. Changes in some targeted PROs (depression, sleep quality, feeling faint or drained) tracked closely with changes in CKD-aP: the proportion of patients reporting &amp;gt; = 3 nights/week of restless sleep increased from 38% to 48% in the No/Yes group, decreased from 48% to 40% in the Yes/No group, and was unchanged between Years 1 and 2 in the No/No and Yes/Yes groups (Table 1). Changes in more general PROs (physical [PCS] and mental [MCS] component summary scores) were modest, and only varied by 2–3 points across the 4 CKD-aP exposure groups. The all-cause mortality HR (95% confidence interval), compared with the No/No reference group, was 1.22 (0.99–1.51) for Yes/No, 1.32 (1.07–1.63) for No/Yes and 1.31 (1.11–1.56) for Yes/Yes. Results for hospitalization and other clinical outcomes are shown in Figure 1. CONCLUSION Our findings indicate that half of chronic HD patients were at least moderately bothered by CKD-aP at some point over the course of 1 year, reflecting an unmet medical need, and that CKD-aP symptoms remained unresolved 12 months later for the majority of HD patients who were bothered by itchy skin at baseline, highlighting the chronic nature of the condition. The trend towards worse patient-reported outcomes for those affected in Year 2 but not Year 1 implicates the consequences of patients’ significant adjustment to this new, often unrelenting, symptom. Those with chronic pruritus had higher rates of hospitalization and cardiovascular events, underscoring the impact of patients with chronic pruritus on hospital systems. Moreover, those affected by pruritus at any point in the year had higher rates of mortality, further highlighting the importance of diagnosing pruritus and investigating its effect on cardiovascular events. Future research should investigate potential causes of CKD-aP symptoms more systematically and focus on how potential treatments can aide in patients’ relief.

109P Routine collection of patient-reported outcomes: Impact of breast cancer therapies on body image

Body image (BI) is a crucial aspect of quality of life (QoL) in breast cancer (BC) patients. Breast-conserving therapy and mastectomy are equally safe BC treatment options. This study examined the postoperative impact on BI to guide treatment decision and preserve QoL.

ESyM: An Electronic Health Record-Integrated Patient-Reported Outcomes-Based Cancer Symptom Management Program Used by Six Diverse Health Systems.

Collecting patient-reported outcomes (PROs) can improve symptom control and quality of life, enhance doctor-patient communication, and reduce acute care needs for patients with cancer. Digital solutions facilitate PRO collection, but without robust electronic health record (EHR) integration, effective deployment can be hampered by low patient and clinician engagement and high development and deployment costs. The important components of digital PRO platforms have been defined, but procedures for implementing integrated solutions are not readily available. As part of the NCI's IMPACT consortium, six health care systems partnered with Epic to develop an EHR-integrated, PRO-based electronic symptom management program (eSyM) to optimize postoperative recovery and well-being during chemotherapy. The agile development process incorporated user-centered design principles that required engagement from patients, clinicians, and health care systems. Whenever possible, the system used validated content from the public domain and took advantage of existing EHR capabilities to automate processes. eSyM includes symptom surveys on the basis of the PRO-Common Terminology Criteria for Adverse Events (PRO-CTCAE) plus two global wellness questions; reminders and symptom self-management tip sheets for patients; alerts and symptom reports for clinicians; and population management dashboards. EHR dependencies include a secure Health Insurance Portability and Accountability Act-compliant patient portal; diagnosis, procedure and chemotherapy treatment plan data; registries that identify and track target populations; and the ability to create reminders, alerts, reports, dashboards, and charting shortcuts. eSyM incorporates validated content and leverages existing EHR capabilities. Build challenges include the innate technical limitations of the EHR, the constrained availability of site technical resources, and sites' heterogenous EHR configurations and policies. Integration of PRO-based symptom management programs into the EHR could help overcome adoption barriers, consolidate clinical workflows, and foster scalability and sustainability. We intend to make eSyM available to all Epic users.

Remote assessment of myotonic dystrophy type 1: A feasibility study.

Remote study visits (RSVs) are emerging as important tools for clinical research. We tested the feasibility of using RSVs to evaluate patients with myotonic dystrophy type 1 (DM1), including remote quantitative assessment of muscle function, and we assessed correlations of remote assessments with patient-reported function. Twenty three subjects with DM1 were consented remotely. Toolkits containing a tablet computer, grip dynamometer, and spirometer were shipped to participants. The tablets were loaded with software for video-conferencing and questionnaires about functional impairment, patient experience with technology, and willingness to participate in future remote studies. Grip strength, forced vital capacity, peak cough flow, timed-up-and-go (TUG), and grip myotonia (hand opening time) were determined during RSVs. We assessed correlations of remote assessments with patient-reported outcomes of muscle function and with CTG repeat size. All 23 subjects completed RSVs. 95% of participants were able to complete all components of the remote study. All toolkit components were returned upon completion. Grip strength and TUG demonstrated moderate to strong correlations with self-reported inventories of upper and lower extremity impairment, respectively (ρ=0.7 and ρ=-0.52). A total of 91% of subjects expressed interest in participating in future RSVs. Results of this study support the feasibility of using portable devices and video-conferencing for remote collection of patient-reported outcomes and quantitative assessment of muscle function in DM1.

Identifying Patients Whose Symptoms Are Underrecognized During Treatment With Breast Radiotherapy

Understanding whether physicians accurately detect symptoms in patients with breast cancer is important because recognition of symptoms facilitates supportive care, and clinical trials often rely on physician assessments using Common Toxicity Criteria for Adverse Events (CTCAE). To compare the patient-reported outcomes (PROs) of patients with breast cancer who received radiotherapy from January 1, 2012, to March 31, 2020, with physicians' CTCAE assessments to assess underrecognition of symptoms. This cohort study included a total of 29 practices enrolled in the Michigan Radiation Oncology Quality Consortium quality initiative. Of 13 725 patients with breast cancer who received treatment with radiotherapy after undergoing lumpectomy, 9941 patients (72.4%) completed at least 1 PRO questionnaire during treatment with radiotherapy and were evaluated for the study. Of these, 9868 patients (99.3%) were matched to physician CTCAE assessments that were completed within 3 days of the PRO questionnaires. Patient and physician ratings of 4 symptoms (pain, pruritus, edema, and fatigue) were compared. We used multilevel multivariable logistic regression to evaluate factors associated with symptom underrecognition, hypothesizing that it would be more common in racial and ethnic minority groups. Of 9941 patients, all were female, 1655 (16.6%) were Black, 7925 (79.7%) were White, and 361 (3.6%) had Other race and ethnicity (including American Indian/Alaska Native, Arab/Middle Eastern, and Asian), either as self-reported or as indicated in the electronic medical record. A total of 1595 (16.0%) were younger than 50 years, 2874 (28.9%) were age 50 to 59 years, 3353 (33.7%) were age 60 to 69 years, and 2119 (21.3%) were 70 years or older. Underrecognition of symptoms existed in 2094 of 6781 (30.9%) observations of patient-reported moderate/severe pain, 748 of 2039 observations (36.7%) of patient-reported frequent pruritus, 2309 of 4492 observations (51.4%) of patient-reported frequent edema, and 390 of 2079 observations (18.8%) of patient-reported substantial fatigue. Underrecognition of at least 1 symptom occurred at least once for 2933 of 5510 (53.2%) of those who reported at least 1 substantial symptom. Factors independently associated with underrecognition were younger age (younger than 50 years compared with 60-69 years: odds ratio [OR], 1.35; 95% CI, 1.14-1.59; P < .001; age 50-59 years compared with 60-69 years: OR, 1.19; 95% CI, 1.03-1.37; P = .02), race (Black individuals compared with White individuals: OR, 1.56; 95% CI 1.30-1.88; P < .001; individuals with Other race or ethnicity compared with White individuals: OR, 1.52; 95% CI, 1.12-2.07; P = .01), conventional fractionation (OR, 1.26; 95% CI, 1.10-1.45; P = .002), male physician sex (OR, 1.54; 95% CI, 1.20-1.99; P = .002), and 2-field radiotherapy (without a supraclavicular field) (OR, 0.80; 95% CI, 0.67-0.97; P = .02). The results of this cohort study suggest that PRO collection may be essential for trials because relying on the CTCAE to detect adverse events may miss important symptoms. Moreover, since physicians in this study systematically missed substantial symptoms in certain patients, including younger patients and Black individuals or those of Other race and ethnicity, improving symptom detection may be a targetable mechanism to reduce disparities.

Does patient preference for online or telephone follow-up impact on response rates and data completeness following injury?

Routine collection of patient-reported outcomes is needed to better understand recovery, benchmark between trauma centers and systems, and monitor outcomes over time. A key component of follow-up methodology is the mode of administration of outcome measures with multiple options available. We aimed to quantify patient preference and compare the response rates and data completeness for telephone and online completion in trauma patients. A registry-based cohort study of adult (16 years and older) patients registered to the Victorian State Trauma Registry and Victorian Orthopedic Trauma Outcomes Registry from April 2020 to December 2020 was undertaken. Survivors to discharge were contacted by telephone and offered the option of telephone or online completion of 6-month follow-up using the five-level EuroQol five-dimension (EQ-5D-5L) questionnaire and the 12-item World Health Organization Disability Assessment Schedule (WHODAS). The online and telephone groups were compared for differences in characteristics, follow-up rates, and data completeness. Multivariable logistic regression was used to identify predictors of choosing online completion. Of the 3,886 patients, 51% (n = 1,994) chose online follow-up, and the follow-up rates were lower for online (77%), compared with telephone (89%), follow-up. Younger age, higher socioeconomic status, and preferred language other than English were associated with higher adjusted odds of choosing online completion. Admission to intensive care was associated with lower adjusted odds of choosing online completion. Completion rate for the EQ-5D-5L utility score was 97% for both groups. A valid total 12-WHODAS score could be calculated for 63% of online respondents compared with 86% for the telephone group. More than half of trauma patients opted for online completion. Completion rates did differ depending on the questionnaire and telephone follow-up rates were higher. Nevertheless, given the wide diversity of the trauma population, the high rate of online uptake, and potential resource constraints, the study findings largely support the use of dual methods for follow-up. Prognostic/Epidemiological, Level III.