Optimization of alert notifications in electronic patient-reported outcome (ePRO) remote symptom monitoring systems (AFT-39).

PURPOSE: Clinical benefits result from electronic patient-reported outcome (ePRO) systems that enable remote symptom monitoring. Although clinically useful, real-time alert notifications for severe or worsening symptoms can overburden nurses. Thus, we aimed to algorithmically identify likely non-urgent alerts that could be suppressed. METHODS: We evaluated alerts from the PRO-TECT trial (Alliance AFT-39) in which oncology practices implemented remote symptom monitoring. Patients completed weekly at-home ePRO symptom surveys, and nurses received real-time alert notifications for severe or worsening symptoms. During parts of the trial, patients and nurses each indicated whether alerts were urgent or could wait until the next visit. We developed an algorithm for suppressing alerts based on patient assessment of urgency and model-based predictions of nurse assessment of urgency. RESULTS: 593 patients participated (median age = 64 years, 61% female, 80% white, 10% reported never using computers/tablets/smartphones). Patients completed 91% of expected weekly surveys. 34% of surveys generated an alert, and 59% of alerts prompted immediate nurse actions. Patients considered 10% of alerts urgent. Of the remaining cases, nurses considered alerts urgent more often when patients reported any worsening symptom compared to the prior week (33% of alerts with versus 26% without any worsening symptom, p = 0.009). The algorithm identified 38% of alerts as likely non-urgent that could be suppressed with acceptable discrimination (sensitivity = 80%, 95% CI [76%, 84%]; specificity = 52%, 95% CI [49%, 55%]). CONCLUSION: An algorithm can identify remote symptom monitoring alerts likely to be considered non-urgent by nurses, and may assist in fostering nurse acceptance and implementation feasibility of ePRO systems.

Identifying meaningful change on PROMIS short forms in cancer patients: a comparison of item response theory and classic test theory frameworks.

BACKGROUND: This study compares classical test theory and item response theory frameworks to determine reliable change. Reliable change followed by anchoring to the change in categorically distinct responses on a criterion measure is a useful method to detect meaningful change on a target measure. METHODS: Adult cancer patients were recruited from five cancer centers. Baseline and follow-up assessments at 6 weeks were administered. We investigated short forms derived from PROMIS® item banks on anxiety, depression, fatigue, pain intensity, pain interference, and sleep disturbance. We detected reliable change using reliable change index (RCI). We derived the T-scores corresponding to the RCI calculated under IRT and CTT frameworks using PROMIS® short forms. For changes that were reliable, meaningful change was identified using patient-reported change in PRO-CTCAE by at least one level. For both CTT and IRT approaches, we applied one-sided tests to detect reliable improvement or worsening using RCI. We compared the percentages of patients with reliable change and reliable/meaningful change. RESULTS: The amount of change in T score corresponding to RCICTT of 1.65 ranged from 5.1 to 9.2 depending on domains. The amount of change corresponding to RCIIRT of 1.65 varied across the score range, and the minimum change ranged from 3.0 to 8.2 depending on domains. Across domains, the RCICTT and RCIIRT classified 80% to 98% of the patients consistently. When there was disagreement, the RCIIRT tended to identify more patients as having reliably changed compared to RCICTT if scores at both timepoints were in the range of 43 to 78 in anxiety, 45 to 70 in depression, 38 to 80 in fatigue, 35 to 78 in sleep disturbance, and 48 to 74 in pain interference, due to smaller standard errors in these ranges using the IRT method. The CTT method found more changes compared to IRT for the pain intensity domain that was shorter in length. Using RCICTT, 22% to 66% had reliable change in either direction depending on domains, and among these patients, 62% to 83% had meaningful change. Using RCIIRT, 37% to 68% had reliable change in either direction, and among these patients, 62% to 81% had meaningful change. CONCLUSION: Applying the two-step criteria demonstrated in this study, we determined how much change is needed to declare reliable change at different levels of baseline scores. We offer reference values for percentage of patients who meaningfully change for investigators using the PROMIS instruments in oncology.

Nuts and Bolts of Patient-Reported Outcomes in Orthopaedics.

Patient-reported outcomes (PROs) are commonly used in orthopaedic clinical practice, comparative effectiveness research (CER), and label claims. In this paper, we provide an overview of PROs, their development, validation, and use in orthopaedic research with examples and conclude with practical guidelines for researchers and reviewers. We discuss considerations for conceptual framework, validity, reliability, factor analysis, and measurement of change with Knee Injury and Osteoarthritis Outcome score (KOOS), as an example. We also describe advantages of instruments developed based on item response theory and statistical analyses for data collected using PRO measures. Please visit the following (https://www.youtube.com/watch?v=4p-DtZgUHOA&t=354s) for a video that explains the highlights of the paper in practical terms.

Effects of patient-reported outcome assessment order.

BACKGROUND: In clinical trials and clinical practice, patient-reported outcomes are almost always assessed using multiple patient-reported outcome measures at the same time. This raises concerns about whether patient responses are affected by the order in which the patient-reported outcome measures are administered. METHODS: This questionnaire-based study of order effects included adult cancer patients from five cancer centers. Patients were randomly assigned to complete questionnaires via paper booklets, interactive voice response system, or tablet web survey. Linear Analogue Self-Assessment, Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, and Patient-Reported Outcomes Measurement Information System assessment tools were each used to measure general health, physical function, social function, emotional distress/anxiety, emotional distress/depression, fatigue, sleep, and pain. The order in which the three tools, and domains within tools, were presented to patients was randomized. Rates of missing data, scale scores, and Cronbach's alpha coefficients were compared by the order in which they were assessed. Analyses included Cochran-Armitage trend tests and mixed models adjusted for performance score, age, sex, cancer type, and curative intent. RESULTS: A total of 1830 patients provided baseline patient-reported outcome assessments. There were no significant trends in rates of missing values by whether a scale was assessed earlier or later. The largest order effect for scale scores was due to a large mean score at one assessment time point. The largest difference in Cronbach's alpha between the versions for the Patient-Reported Outcomes Measurement Information System scales was 0.106. CONCLUSION: The well-being of a cancer patient has many different aspects such as pain, fatigue, depression, and anxiety. These are assessed using a variety of surveys often collected at the same time. This study shows that the order in which the different aspects are collected from the patient is not important.

Association of Function, Symptoms, and Social Support Reported in Standardized Outpatient Clinic Questionnaires With Subsequent Hospital Discharge Disposition and 30-Day Readmissions.

OBJECTIVE: To determine whether patient-reported information, routinely collected in an outpatient setting, is associated with readmission within 30 days of discharge and/or the need for post-acute care after a subsequent hospital admission. DESIGN: Retrospective cohort study. Six domains of patient-reported information collected in the outpatient setting (psychological distress, respiratory symptoms, musculoskeletal pain, family support, mobility, and activities of daily living [ADLs]) were linked to electronic health record hospitalization data. Mixed effects logistic regression models with random intercepts were used to identify the association between the 6 domains and outcomes. SETTING: Outpatient clinics and hospitals in a Midwestern health system. PARTICIPANTS: 7671 patients who were hospitalized 11,445 times between May 2004 and May 2014 (N=7671). INTERVENTION: None. MAIN OUTCOME MEASURES: 30-day hospital readmission and discharge home vs facility. RESULTS: Domains were significantly associated with 30-day readmission and placement in a facility. Specifically, mobility (odds ratio [OR]=1.30; 95% confidence interval [CI], 1.16, 1.46), ADLs (OR=1.27; 95% CI, 1.13, 1.42), respiratory symptoms (OR=1.26; 95% CI, 1.12, 1.41), and psychological distress (OR=1.20; 95% CI, 1.07, 1.35) had the strongest associations with 30-day readmission. The ADL (OR=2.52; 95% CI, 2.26, 2.81), mobility (OR=2.35; 95% CI, 2.10, 2.63), family support (OR=2.28; 95% CI, 1.98, 2.62), and psychological distress (OR=1.38; 95% CI, 1.25, 1.52) domains had the strongest associations with discharge to an institution. CONCLUSIONS: Patient-reported function, symptoms, and social support routinely collected in outpatient clinics are associated with future 30-day readmission and discharge to an institutional setting. Whether these data can be leveraged to guide interventions to address patient needs and improve outcomes requires further research.

Choosing and Using Patient-Reported Outcome Measures in Clinical Practice.

The increasing use of patient-reported outcome (PRO) measures is forcing clinicians and health care systems to decide which to select and how to incorporate them into their records and clinical workflows. This overview addresses 3 topics related to these concerns. First, a literature review summarizes key psychometric and practical factors (such as reliability, responsiveness, computer adaptive testing, and interpretability) in choosing PROs for clinical practice. Second, 3 clinical decision support issues are highlighted: gathering PROs, electronic health record effect on providers, and incorporating PROs into clinical decision support design and implementation. Lastly, the salience of crosscutting domains as well as 9 key pragmatic decisions are reviewed. Crosscutting domains are those that are relevant across most medical and mental health conditions, such as the SPADE symptom pentad (sleep problems, pain, anxiety, depression, low energy/fatigue) and physical functioning. The 9 pragmatic decisions include (1) generic vs disease-specific scales; (2) single- vs multidomain scales; (3) universal scales vs user-choice selection; (4) number of domains to measure; (5) prioritization of domains when multiple domains are assessed; (6) action thresholds; (7) clinical purpose (screening vs monitoring); as well as the (8) frequency and (9) logistical aspects of PRO administration.

Measuring Attitudes About Genomic Medicine: Validation of the Genomic Orientation Scale (GO Scale).

OBJECTIVES: Assessing public attitudes about genomic medicine is critical for anticipating patient receptivity to clinical applications of genomics. Although scholars have highlighted the importance of assessing stakeholder opinions and views regarding advances in clinical genomics, to date there has not been a robust tool for measuring these attitudes. We designed a study to evaluate the validity of an instrument we developed for measuring attitudes about genomic medicine. METHODS: We used psychometric methods to validate the Genomic Orientation Scale (GO Scale). Our goal was to create an easy-to-use tool for evaluating positive and negative attitudes about genomic medicine. RESULTS: We describe the validation testing of the GO Scale in a nationally representative sample of 1536 individuals residing in the United States. We report results from convergent and divergent validity testing and Rasch modeling analysis. The study produced a 26-item scale with 2 dimensions-optimism and pessimism. CONCLUSIONS: The GO Scale may be used to characterize attitudinal perspectives among patients, clinicians, and the public. The GO Scale may also be useful in evaluating shifts in attitude over time, for example, following educational interventions, which has not been feasible to date.

Functional Outcomes and Health-Related Quality of Life Before and After Primary Total Knee Replacement for Patients From Diverse Geographic Regions.

BACKGROUND: The purpose of this study was to investigate whether patient-reported knee function and health status before and after primary total knee replacement (TKR) at an academic medical center differs among patients from diverse geographic regions. METHODS: We assessed patient-reported outcomes (PROs) as measured by the Oxford Knee Score (OKS) and EuroQoL-5D (EQ-5D) in 2855 TKR patients at preprimary and one year postprimary TKR procedure between January 1, 2012 and June 30, 2014. We compared the demographic characteristics, response rates, and changes in OKS, EQ-5D, and EQ visual analog scale among local, regional, and national patient groups. Patient- or hospital-related predictors of the postoperative scores were identified after controlling for preoperative scores on the PRO measures. RESULTS: Local patients had more comorbid conditions. Groups were similar in clinical outcomes such as length of stay at hospital, complication, and reoperation rates. Local, regional, and national patients had similar response rates and reported a similar level of knee function and health-related quality of life before and after TKR. Eighty nine percent had clinically important improvement on OKS, 69% on EQ-5D index, and 28% EQ visual analog scale, and there were no differences among groups in the proportions of clinically meaningful change. Better postoperative PRO scores were associated with older age, shorter hospital stay, fewer comorbidities, nonsmoking status, fewer complications, and private health insurance. CONCLUSION: Some patient characteristics such as comorbidities were greater in the local patient cohort versus the national cohort. Nevertheless, clinical outcomes and PROs were comparable across all geographic tiers.

Assessing whether ad hoc clinician-generated patient questionnaires provide psychometrically valid information.

BACKGROUND: The provision of psychometrically valid patient reported outcomes (PROs) improves patient outcomes and reflects their quality of life. Consequently, ad hoc clinician-generated questionnaires of the past are being replaced by more rigorous instruments. This change, while beneficial, risks the loss/orphaning of decades-long information on difficult to capture/chronically ill populations. The goal of this study was to assess to the quality of data retrieved from these legacy questionnaires. METHODS: Participants included 8563 patients who generated a total of 12,626 hospital admissions over the 2004-2014 study period. Items used to screen for issues related to function, mood, symptoms, and social support among patients with chronic disease were identified in our medical center's patient information questionnaire. Cluster and exploratory factor analyses (EFA) followed by multidimensional item response theory (MIRT) analyses were used to select items that defined factors. Scores were derived with summation and MIRT approaches; inter-factor relationships and relationships of factor scores to assigned diagnostic codes were assessed. Rasch analyses assessed the constructs' measurement properties. RESULTS: Literature review and clinician interviews yielded four hypothesized constructs: psychological distress/wellbeing, symptom burden, social support, and physical function. Rasch analyses showed that, while all had good measurement properties, only one, function, separated individuals well. In exploratory factor analyses (EFA), 11 factors representing depression, respiratory symptoms, musculoskeletal pain, family support, mobility, activities of daily living, alcohol consumption, weight loss, fatigue, neurological disorders, and fear at home were identified. Based on the agreement between EFA and cluster analyses as well as Cronbach's alpha, six domains were retained for analyses. Correlations were strong between activities of daily living and mobility (.84), and moderate between pain and mobility (.37) and psychological distress (.59) Known-group validity was supported from the relationships between factor scores and the relevant diagnostic code assignments (.12 to .20). CONCLUSIONS AND DISCUSSION: Items from ad hoc clinician-generated patient information questionnaires can be aggregated into valid factors that assess supportive care domains among chronically ill patients. However, the binary response options offered by many screening items limit their information content and consequently, as highlighted by Rasch analyses, their ability to meaningfully discriminate trait levels in these populations.

Known-groups validity and responsiveness to change of the Patient Experience with Treatment and Self-management (PETS vs. 2.0): a patient-reported measure of treatment burden.

PURPOSE: The purpose of this study was to test the known-groups validity and responsiveness to change of the Patient Experience with Treatment and Self-management (PETS, vs. 2.0), a measure of treatment burden. METHODS: The PETS and other standard measures were mailed at baseline and 12-month follow-up to adults living with multiple chronic conditions in southeast Minnesota (USA). A sample of 365 people (mean age = 62.1 years) completed both surveys. Baseline, 12-month, and changes in PETS burden scores were examined. Clinical anchors used to test validity included number of diagnoses (2-4 vs. 5+), mental health diagnosis (yes/no), medication adherence and health literacy (suboptimal/optimal), and changes in self-efficacy, global physical, and global mental health (worsening/improving). Independent-samples t-tests were used to compare scores. RESULTS: PETS scales showed good internal consistency (αs ≥ 0.80). There were few differences across number of diagnoses, but having a mental health diagnosis was associated with higher baseline PETS burden scores (Ps < .05). Suboptimal medication adherence and health literacy over time were associated with worse 12-month PETS burden scores (Ps < .05). Compared with improvements, declines over time in self-efficacy, global physical health, and global mental health were each associated with worsening change scores on PETS impact summary, medical expenses, and bother due to medication reliance and medication side effects (Ps < .05). CONCLUSION: Among multi-morbid adults, the PETS demonstrated evidence of known-groups validity and responsiveness to change across both objective (e.g., mental health diagnoses) and subjective anchors (e.g., changes in self-efficacy, global physical, and global mental health).

Deriving and validating a brief measure of treatment burden to assess person-centered healthcare quality in primary care: a multi-method study.

BACKGROUND: In primary care there is a need for more quality measures of person-centered outcomes, especially ones applicable to patients with multiple chronic conditions (MCCs). The aim of this study was to derive and validate a short-form version of the Patient Experience with Treatment and Self-management (PETS), an established measure of treatment burden, to help fill the gap in quality measurement. METHODS: Patient interviews (30) and provider surveys (30) were used to winnow items from the PETS (60 items) to a subset targeting person-centered care quality. Results were reviewed by a panel of healthcare providers and health-services researchers who finalized a pilot version. The Brief PETS was tested in surveys of 200 clinic and 200 community-dwelling MCC patients. Surveys containing the Brief PETS and additional measures (e.g., health status, medication adherence, quality of care, demographics) were administered at baseline and follow-up. Correlations and t-tests were used to assess validity, including responsiveness to change of the Brief PETS. Effect sizes (ES) were calculated on mean differences. RESULTS: Winnowing and panel review resulted in a 34-item Brief PETS pilot measure that was tested in the combined sample of 400 (mean age = 57.9 years, 50% female, 48% white, median number of conditions = 5). Reliability of most scales was acceptable (alpha > 0.70). Brief PETS scores were associated with age, income, health status, and quality of chronic illness care at baseline (P < .05; rho magnitude range: 0.16-0.66). Furthermore, Brief PETS scores differentiated groups based on marital and education status, presence/absence of a self-management routine, and optimal/suboptimal medication adherence (P < .05; ES range: 0.25-1.00). Declines in patient-reported physical or mental health status over time were associated with worsening PETS burden scores, while improvements were associated with improving PETS burden scores (P < .05; ES range: 0.04-0.44). Among clinic patients, 91% were willing to complete the Brief PETS as part of their clinic visits. CONCLUSIONS: The Brief PETS (final version: 32 items) is a reliable and valid tool for assessing person-centered care quality related to treatment burden. It holds promise as a means of giving voice to patient concerns about the complexity of disease management.

Patient-reported outcome domains for the esophageal CONDUIT report card: a prospective trial to establish domains.

BACKGROUND: Health-related quality of life (QoL) deteriorates immediately after esophagectomy. Patients may benefit from periodic assessments to detect increased morbidity on the basis of subjective self-reports. Using input from patients and health care providers, we developed a brief prototype for the esophageal conduit questionnaire (Mayo Clinic Esophageal Conduit Outcomes Noting Dysphagia/Dumping, and Unknown outcomes with Intermittent symptoms over Time after esophageal reconstruction [CONDUIT] Report Card) and previously used it in comparative research. The present study aimed to expand its content and establish health-related QoL and symptom domains of a patient-reported postesophagectomy conduit evaluation tool. METHODS: We expanded tool content by selecting items measuring patient-reported symptoms from existing questionnaires or written de novo. A multidisciplinary group of clinician content-matter experts approved the draft tool, together with a designated patient advocate. The expanded tool was administered to patients postesophagectomy from March 1 to November 30, 2016. We established domains of conduit performance for score reporting through data analysis with exploratory factor analyses. We assessed psychometric properties such as dimensionality, internal consistency, and inter-item correlations in each domain and compared content coverage with other existing measures intended for this patient population. For data that were missing less than 50% of patient responses, the missing values were imputed. RESULTS: Five multi-item domains were established from data of 76 patients surveyed after esophagectomy; single items were used to assess stricture and conduit emptying. For every multi-item domain, dominance of 1 factor was present. Internal consistency reliability estimates for the domains were 0.87, 0.78, 0.75, 0.80, and 0.83 and average inter-item correlations were 0.40, 0.50, 0.40, 0.33, and 0.73 for dysphagia, reflux, dumping-gastrointestinal symptoms, dumping-hypoglycemia, and pain, respectively. Some items observed to have lower inter-item correlation were reworded or flagged for removal at future validation. For reflux and dumping-related hypoglycemia, additional items were written after these analyses. CONCLUSIONS: The CONDUIT Report Card is a novel questionnaire for assessing QoL and symptoms of patients after esophageal reconstruction. It covers major symptoms of these patients and has good content validity and psychometric properties. The tool can be used to help direct patient care, guide intervention, and compare efficacy of different treatment options. TRIAL REGISTRATION: ClinicalTrials.gov identifier No. 02530983 on 8/18/2015.

The PROMIS fatigue item bank has good measurement properties in patients with fibromyalgia and severe fatigue.

PURPOSE: Efficient management of fibromyalgia (FM) requires precise measurement of FM-specific symptoms. Our objective was to assess the measurement properties of the Patient-Reported Outcome Measurement Information System (PROMIS) fatigue item bank (FIB) in people with FM. METHODS: We applied classical psychometric and item response theory methods to cross-sectional PROMIS-FIB data from two samples. Data on the clinical FM sample were obtained at a tertiary medical center. Data for the U.S. general population sample were obtained from the PROMIS network. The full 95-item bank was administered to both samples. We investigated dimensionality of the item bank in both samples by separately fitting a bifactor model with two group factors; experience and impact. We assessed measurement invariance between samples, and we explored an alternate factor structure with the normative sample and subsequently confirmed that structure in the clinical sample. Finally, we assessed whether reporting FM subdomain scores added value over reporting a single total score. RESULTS: The item bank was dominated by a general fatigue factor. The fit of the initial bifactor model and evidence of measurement invariance indicated that the same constructs were measured across the samples. An alternative bifactor model with three group factors demonstrated slightly improved fit. Subdomain scores add value over a total score. CONCLUSIONS: We demonstrated that the PROMIS-FIB is appropriate for measuring fatigue in clinical samples of FM patients. The construct can be presented by a single score; however, subdomain scores for the three group factors identified in the alternative model may also be reported.

PRO-Angoff method for remote standard setting: establishing clinical thresholds for the upper digestive disease tool.

BACKGROUND: The Upper Digestive Disease (UDD) Tool™ is used to monitor symptom frequency, intensity, and interference across nine symptom domains and includes two Patient-Reported Outcome Measurement Information System (PROMIS) domains assessing physical and mental health. This study aimed to establish cut scores for updated symptom domains through standard setting exercises and evaluate the effectiveness and acceptability of virtual standard setting. METHODS: The extended Angoff method was employed to determine cut scores. Subject matter experts refined performance descriptions for symptom control categories and achieved consensus. Domains were categorized into good, moderate, and poor symptom control. Two cut scores were established, differentiating good vs. moderate and moderate vs. poor. Panelists estimated average scores for 100 borderline patients per item. Cut scores were computed based on the sum of the average ratings for individual questions, converted to 0-100 scale. RESULTS: Performance descriptions were refined. Panelists discussed that interpretation of the scores should take into account the timing of symptoms after surgery and patient populations, and the importance of items asking symptom frequency, severity, and interference with daily life. The good/moderate cut scores ranged from 21.3 to 35.0 (mean 28.6, SD 3.6) across domains, and moderate/poor ranged from 47.5 to 71.3 (mean 54.5, SD 7.0). CONCLUSIONS: Panelists were confident in the virtual standard setting process, expecting valid cut scores. Future studies can further validate the cut scores using patient perspectives and collect patient and physician preferences for displaying contextual items on patient- and physician-facing dashboard.

Extending venous thromboembolism secondary prevention with apixaban in cancer patients. The EVE trial.

BACKGROUND: Cancer-associated venous thromboembolism (VTE) management guideline recommendations include continued therapeutic anticoagulation while active cancer persists. The Federal Drug Administration label for apixaban for secondary VTE prevention includes a dose reduction to 2.5 mg twice daily after 6 months of treatment. OBJECTIVES: The study's purpose was to determine whether this dose reduction is advisable for cancer-associated VTE. METHODS: A randomized, double-blind trial compared apixaban 2.5 mg with 5 mg twice daily for 12 months among cancer patients with VTE who had completed 6 to 12 months of anticoagulation therapy. The primary outcome was combined major bleeding plus clinically relevant nonmajor bleeding. RESULTS: Of 370 patients recruited, 360 were included in the intention-to-treat analyses. Major plus clinically relevant nonmajor bleeding occurred in 16 of 179 patients (8.9%) in the apixaban 2.5 mg group compared with 22 of 181 patients (12.2%) in the 5 mg group (hazard ratio [HR], 0.72; 95% CI, 0.38-1.37; P = .39). Major bleeding occurred in 2.8% of the apixaban 2.5 mg group and in 2.2% of the 5 mg group (HR, 1.26; 95% CI, 0.34-4.66; P = .73). Recurrent VTE or arterial thrombosis occurred in 9 of 179 patients (5.0%) in the apixaban 2.5 mg group and 9 of 181 patients (5.0%) in the 5 mg group (HR, 1.0; 95% CI, 0.40-2.53; P = 1.00). All-cause mortality rates were similar between groups, 13% vs 12% (HR, 1.14; 95% CI, 0.63-2.04; P = .67). CONCLUSION: For secondary prevention of cancer-associated VTE, apixaban 2.5 mg compared with 5 mg twice daily did not lower combined bleeding events (EVE trial NCT03080883).

Palbociclib in adults aged 70 years and older with advanced breast cancer: A phase 2 multicenter trial (Alliance A171601).

INTRODUCTION: Palbociclib is a widely used treatment for advanced breast cancer in older adults. However, the existing evidence regarding its safety and tolerability in this age group is inconsistent and limited to retrospective subgroup or pooled analyses. MATERIALS AND METHODS: We conducted a prospective single-arm multicenter phase 2 study to evaluate the safety and tolerability of palbociclib in participants aged 70 years or older with advanced hormone receptor-positive breast cancer. Participants were given palbociclib in combination with their physician's choice of endocrine therapy (letrozole or fulvestrant). The primary endpoint was the incidence of grade 3+ adverse events (AEs) by six months. Secondary endpoints included AE-related dose delays, dose reductions, early discontinuations, and hospitalizations. Additionally, we compared these endpoints by age groups (70-74 and ≥ 75 years). RESULTS: Of the 90 participants (median age 74 years [70-87]) enrolled, 75.6% (95% confidence interval [CI], 65.4-84.0) had grade 3+ AEs by six months. The most frequent grade 3+ AEs were neutropenia (61%), fatigue (4%), and nausea (3%). Febrile neutropenia was uncommon (1.1%). Due to AEs, 36% had dose delays, 34% had dose reductions, 10% had early discontinuations, and 10% had hospitalizations. Compared to those aged 70-74 years, participants aged ≥75 years had higher rates of early discontinuations (5.9% vs 15.9%, a difference of 9.5% [95% CI 3.5%-22.5%]). DISCUSSION: Palbociclib has an overall favorable safety profile in adults aged ≥70 with advanced breast cancer. However, adults ≥75 years had a trend toward higher rates of AE-related early discontinuations compared to those 70-74 years. Further research is needed to evaluate tolerability and improve the delivery of palbociclib in older adults. CLINICALTRIALS: gov:NCT03633331.

Relationships Among Health Insurance Literacy, Financial Toxicity, and Sociodemographic Factors in Patients With Cancer.

PURPOSE: The objective of the study was to describe the prevalence of health insurance literacy (HIL) and investigate how patient-reported outcome measures assessing HIL are related to financial toxicity in patients with cancer. METHODS: We assessed HIL and financial toxicity in 404 patients enrolled between December 2019 and January 2021 at two medical centers in the United States. We conducted exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) to explore and test the relationships among the factors and items. We fit structural equation models (SEMs) to find the relationships among the factors and sociodemographic/clinical characteristics. RESULTS: The EFA revealed items loaded on four factors: knowledge about health insurance, confidence related to HIL (HIL confidence), information-seeking behavior related to health insurance, and financial toxicity. The four-factor CFA model had good fit statistics (comparative fit index, 0.960; Tucker-Lewis index, 0.958; root mean square error of approximation, 0.046; and standardized root mean square residual, 0.086). In SEM, income, education level, and race positively predicted knowledge about health insurance. Knowledge about health insurance and number of total lines of cancer treatment was positively associated with HIL confidence. Higher income, older age, and HIL confidence were associated with less financial toxicity. Higher levels of financial toxicity, HIL confidence, and knowledge were associated with greater information-seeking behavior. CONCLUSION: Our findings showed how different aspects of HIL are related to financial toxicity even after adjustment for sociodemographic and clinical characteristics. Future studies should investigate the longitudinal relationships among these factors to help develop interventions to mitigate financial toxicity.

Agreement Between Upper Digestive Disease App and Provider Evaluation of Esophagectomy Symptoms in a Mobile App Tool.

BACKGROUND: The objective of this study was to assess the criterion validity of score thresholds for the Upper Digestive Disease (UDD) App. METHODS: From December 15, 2017, to December 15, 2020, patients presenting after esophagectomy were offered the UDD App concurrent with a provider visit. This tool consists of 67 questions including 5 novel domains. Score thresholds were used to assign patients to a good, moderate, or poor category on the basis of domain scores. Providers were given performance descriptions for each domain and asked to assign patients to a category on the basis of their clinical evaluation. The weighted κ statistic was used to determine the magnitude of agreement between classifications based on the patients' UDD App scores and the providers' clinical evaluation. RESULTS: Fifty-nine patients in the study (76% male; median age, 63 years [interquartile range, 57-72 years]) reported outcomes using the UDD App. Providers reviewed between 1 and 10 patients at a median time of 296.5 days (interquartile range, 50-975 days) after esophagectomy. The magnitude of agreement between patients and providers was moderate for dysphagia (κ = 0.52; P < .001) and reflux (κ = 0.42; P < .001). Dumping-related hypoglycemia (κ = 0.03; P = .148), gastrointestinal complaints (κ = 0.02; P = .256), and pain (κ = 0.05; P < .184) showed minimal agreement, with providers underestimating the symptoms and problems reported by patients in these domains. CONCLUSIONS: Although there was agreement between UDD App assessment and provider evaluation of dysphagia and reflux after esophagectomy, there was discordance of scoring for dumping-related symptoms and pain. Future research is needed to determine whether thresholds for pain and dumping domains need to be revised or whether additional provider education on performance descriptions is needed.

Do Organizational Values and Leadership Impact Staff Engagement, Wellbeing, and Patient Satisfaction?

Purpose: Organizational culture has been shown to be an important characteristic that influences behaviors of groups and individuals within an organization. This study seeks to examine the relationships among various organizational values, staff engagement, staff wellbeing, and patient satisfaction in community hospitals. Participants and Methods: Organizational values and engagement data were retrieved from all-staff survey results from 387 clinical units at Mayo Clinic Health Systems. For patient satisfaction data, Press Ganey scores were matched with data for 17 outpatient units from the all-staff survey. Cluster analysis was used to create constructs from the staff satisfaction survey. Reliability was obtained using Cronbach's alpha. Structural equation modeling (SEM) was used to create the measurement model for prediction of constructs. Correlation was used to examine the relationship between culture and patient satisfaction. Results: From the all-staff survey results, we identified nine constructs related to organizational cultural values, staff well-being, and employee engagement. We were able to determine a structural equation model for values and engagement that had an excellent fit. Staff's sense of fairness had a significant impact on how staff provide service excellence. Cultural values of excellence and innovation were positively correlated with large effect size in ten out of eleven patient satisfaction measurement domains and all were statistically significant. Conclusion: Values of excellence had a larger positive relationship with patient satisfaction than all other variables. How staff perceive the level of the organization's commitment to its values had impact on both staff engagement and wellbeing. This study also showed that the construct of wellbeing and patient satisfaction scores are not correlated. Staff will strive to provide excellent experience and good patient care regardless of their state of wellbeing.

Developing & integrating a mobile application tool into a survivorship clinic for esophageal cancer patients.

Esophageal cancer (EC) patients are living longer due to enhanced screening and novel therapeutics, however, the post-esophagectomy long-term management remains challenging for patients, caregivers, and providers. Patients experience significant morbidity and have difficulty managing symptoms. Providers struggle to manage symptoms, affecting patients' quality of life and complicating care coordination between surgical teams and primary care providers. To address these patient unique needs and create a standardized method for evaluating patient reported long-term outcomes after esophagectomy for EC, our team developed the Upper Digestive Disease Assessment tool, which evolved to become a mobile application. This mobile application is designed to monitor symptom burden, direct assessment, and quantify data for patient outcome analysis after foregut (upper digestive) surgery, including esophagectomy. It is available to the public and enables virtual and remote access to survivorship care. Patients using the Upper Digestive Disease Application (UDD App) must consent to enroll, agree to terms of use, and acknowledge use of health-related information prior to gaining access to the UDD App. The results of patients scores can be utilized for triage and assessment. Care pathways can guide management of severe symptoms in a scalable and standardized method. Here we describe the history, process, and methodology for developing a patient-centric remote monitoring program to improve survivorship after EC. Programs like this that facilitate patient-centered survivorship should be an integral part of comprehensive cancer patient care.