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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

Longitudinal trajectories of treatment burden: A prospective survey study of adults living with multiple chronic conditions in the midwestern United States.

Objectives: Determine whether there are different longitudinal patterns of treatment burden in people living with multiple chronic conditions (MCC) and, if so, explore predictors that might reveal potential routes of intervention. Methods: We analyzed data from a prospective mailed survey study of 396 adults living with MCC in southeastern Minnesota, USA. Participants completed a measure of treatment burden, the Patient Experience with Treatment and Self-management (PETS), and valid measures of health-related and psycho-social concepts at baseline, 6, 12, and 24 months. Latent class growth mixture modeling (LCGM) determined trajectories of treatment burden in two summary index scores of the PETS: Workload and Impact. Multivariable logistic regressions were used to identify independent predictors of the trajectories. Results: LCGM supported a 2-class model for PETS Workload, including a group of consistently high workload (N = 69) and a group of consistently low workload (N = 311) over time. A 3-class model was supported for PETS Impact, including groups of consistently high impact (N = 62), consistently low impact (N = 278), and increasing impact (N = 51) over time. Logistic regression analyses showed that the following factors were associated with patterns of consistently high or increasing treatment burden over time: lower health literacy, lower self-efficacy, more interpersonal challenges with others, and worse subjective reports of physical and mental health (all p < .05). Conclusions: Different longitudinal patterns of treatment burden exist among people with MCC. Raising health literacy, enhancing self-efficacy, and lessening the effects of negative social interactions might help reduce treatment burden.

Upper Digestive Disease App for Electronic Patient-Reported Outcomes: A Mixed Methods Pilot Study.

BACKGROUND: Patient-reported outcomes (PROs) can enable communication of symptoms, function, and quality of life. Mobile devices capture PROs electronically (ePRO). The purpose of this study was to determine the feasibility and acceptability of collecting ePROs in esophagectomy patients using the upper digestive disease application (UDD App). METHODS: A single-group, mixed methods design was used to address the study purposes. A convenience sample of esophagectomy patients was recruited after resumption of an oral diet from January 2020 to December 2020. Demographic characteristics (age, sex) and clinical data (surgical procedure) were obtained after informed consent. Participants used the UDD App for 1 year, followed by scripted telephone interviews. Descriptive statistics and thematic analyses of the interviews were the primary data analyses. RESULTS: Sixty-four patients were enrolled (80% male; 62.9 ± 12 years old). Of these, 50 patients initiated 108 evaluations through the UDD app, with 98% completing the questionnaire on the first attempt, indicating feasibility. A subset of 32 patients participated in the scripted telephone interview. Participants (74%) reported high computer literacy; all reported that using the UDD App was easier than or equivalent to a paper form. Interview themes revealed value of the app for identifying problems and enhanced communication with providers and caregivers, with an overall appreciation for the convenience of remote monitoring but concerns about data privacy. CONCLUSIONS: The UDD App is feasible and acceptable for collecting ePROs in esophagectomy patients. Future work will determine whether the UDD App improves symptoms, function, and quality of life.

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.

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.

Receptivity to a Nurse-Led Symptom Management Intervention Among Highly Symptomatic Patients With Cancer.

BACKGROUND: The symptom burden associated with cancer and its treatment can negatively affect patients' quality of life and survival. Symptom-focused collaborative care model (CCM) interventions can improve outcomes, but only if patients engage with them. We assessed the receptivity of severely symptomatic oncology patients to a remote nurse-led CCM intervention. METHODS: In a pragmatic, cluster-randomized, stepped-wedge trial conducted as part of the National Cancer Institute IMPACT Consortium (E2C2, NCT03892967), patients receiving cancer care were asked to rate their sleep disturbance, pain, anxiety, emotional distress, fatigue, and limitations in physical function. Patients reporting at least 1 severe symptom (≥7/10) were offered phone consultation with a nurse symptom care manager (RN SCM). Initially, patients had to "opt-in" to receive a call, but the protocol was later modified so they had to "opt-out" if they did not want a call. We assessed the impact of opt-in vs opt-out framing and patient characteristics on receptiveness to RN SCM calls. All statistical tests were 2-sided. RESULTS: Of the 1204 symptom assessments (from 864 patients) on which at least 1 severe symptom was documented, 469 (39.0%) indicated receptivity to an RN SCM phone call. The opt-out period (odds ratio [OR] = 1.61, 95% confidence interval [CI] = 1.12 to 2.32, P = .01), receiving care at a tertiary care center (OR = 3.59, 95% CI = 2.18 to 5.91, P < .001), and having severe pain (OR = 1.80, 95% CI = 1.24 to 2.62, P = .002) were associated with statistically significantly greater willingness to receive a call. CONCLUSIONS: Many severely symptomatic patients were not receptive to an RN SCM phone call. Better understanding of reasons for refusal and strategies for improving patient receptivity are needed.

Initial validation of a self-report questionnaire based on the Theoretical Domains Framework: determinants of clinician adoption of a novel colorectal cancer screening strategy.

BACKGROUND: Colorectal cancer (CRC) screening for average risk adults age 45 and older continues to be underutilized in the USA. One factor consistently associated with CRC screening completion is clinician recommendation. Understanding the barriers and facilitators of clinical adoption of emerging CRC screening strategies is important in developing effective intervention strategies to improve CRC screening rates. We aimed to develop a questionnaire based on the Theoretical Domains Framework (TDF) to assess determinants of clinical adoption of novel CRC screening strategies, using the multi-target stool DNA test (mt-sDNA; Cologuard®) as an example, and test the psychometric properties of this questionnaire on a sample of US clinicians. METHODS: A web survey was administered between November and December 2019 to a national panel of clinicians including primary care clinicians (PCCs) and gastroenterologists (GIs) to assess 10 TDF constructs with 55 items. Confirmatory factor analysis (CFA) was used to examine whether the a priori domain structure was supported by the data. Discriminant validity of domains was tested with Heterotrait-Monotrait ratio (HTMT). Internal consistency for each scale was assessed using Cronbach's alpha. Criterion validity was assessed with self-reported mt-sDNA use and mt-sDNA recommendation as the outcomes. RESULTS: Complete surveys were received from 814 PCCs and 159 GIs (completion rate, 24.7% of 3299 PCCs and 29.6% of 538 GIs). Providers were excluded from analysis if they indicated not recommending CRC screening to average-risk patients (final N = 973). The final questionnaire consisted of 38 items covering 5 domains: (1) knowledge; (2) skills; (3) identity and social influence; (4) optimism, beliefs about consequences, and intentions; and (5) environmental context and resources. CFA results confirmed a reasonable fit (CFI = 0.948, SRMR = 0.057, RMSEA = 0.080). The domains showed sufficient discriminant validity (HTMT < 0.85), good internal consistency (McDonald's omega > 0.76), and successfully differentiated providers who reported they had ordered mt-sDNA from those who never ordered mt-sDNA and differentiated providers who reported routinely recommending mt-sDNA from those who reported not recommending mt-sDNA. CONCLUSIONS: Findings provide initial evidence for the validity and internal consistency of this TDF-based questionnaire in measuring potential determinants of mt-sDNA adoption for average-risk CRC screening. Further investigation of validity and reliability is needed when adapting this questionnaire to other novel CRC screening strategy contexts.

Score equivalence of paper-, tablet-, and interactive voice response system-based versions of PROMIS, PRO-CTCAE, and numerical rating scales among cancer patients.

BACKGROUND: The study tests the effects of data collection modes on patient responses associated with the multi-item measures such as Patient-Reported Outcomes Measurement System (PROMIS®), and single-item measures such as Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and Numerical Rating Scale (NRS) measures. METHODS: Adult cancer patients were recruited from five cancer centers and administered measures of anxiety, depression, fatigue, sleep disturbance, pain intensity, pain interference, ability to participate in social roles and activities, global mental and physical health, and physical function. Patients were randomized to complete the measures on paper (595), interactive voice response (IVR, 596) system, or tablet computer (589). We evaluated differential item functioning (DIF) by method of data collection using the R software package, lordif. For constructs that showed no DIF, we concluded equivalence across modes if the equivalence margin, defined as ± 0.20 × pooled SD, completely surrounds 95% confidence intervals (CI's) for difference in mean score. If the 95% CI fell totally outside the equivalence margin, we concluded systematic score difference by modes. If the 95% CI partly overlaps the equivalence margin, we concluded neither equivalence nor difference. RESULTS: For all constructs, no DIF of any kind was found for the three modes. The scores on paper and tablet were more comparable than between IVR and other modes but none of the 95% CI's were completely outside the equivalence margins, in which we established neither equivalence nor difference. Percentages of missing values were comparable for paper and tablet modes. Percentages of missing values were higher for IVR (2.3% to 6.5% depending on measures) compared to paper and tablet modes (0.7% to 3.3% depending on measures and modes), which was attributed to random technical difficulties experienced in some centers. CONCLUSION: Across all mode comparisons, there were some measures with CI's not completely contained within the margin of small effect. Two visual modes agreed more than visual-auditory pairs. IVR may induce differences in scores unrelated to constructs being measured in comparison with paper and tablet. The users of the surveys should consider using IVR only when paper and computer administration is not feasible.