Publications by authors named "Antonia Bennett"

73 Publications

Comparison of weekly and daily recall of pain as an endpoint in a randomized phase 3 trial of cabozantinib for metastatic castration-resistant prostate cancer.

Clin Trials 2021 Apr 22:17407745211009547. Epub 2021 Apr 22.

Department of Health Policy and Management, University of North Carolina, Chapel Hill, NC, USA.

Introduction: Scant evidence reveals whether the use of weekly versus daily pain ratings leads to meaningful differences when measuring pain as a clinical trial outcome. We compared the ability of weekly ratings and descriptors of daily ratings to evaluate pain as an endpoint in a randomized phase 3 drug trial.

Methods: Participants ( = 119) with metastatic castration-resistant prostate cancer were randomized to treatment arms and rated their pain on the average and at its worst during a baseline week and at weeks 3, 6, and 12 of study treatment. For each reporting period, participants rated their pain daily for 7 days. On day 7, participants rated their pain over the prior 7 days. We estimated mean differences and intraclass correlation coefficients of the weekly ratings and the mean and the maximum daily ratings. We compared the ability of the weekly ratings and the daily rating descriptors to detect change in pain and evaluated the agreement of the weekly rating and the mean daily rating of pain at its worst to detect treatment response.

Results: For both pain constructs, the weekly rating was consistently higher than the mean daily rating and lower than the maximum daily rating yet was moderately to highly correlated with both daily rating descriptors (intraclass correlation coefficient range = 0.55-0.94). The weekly rating and the daily rating descriptors consistently detected change in pain for the study sample and participant subgroups. Substantial agreement existed between the weekly rating and the mean daily rating of pain at its worst when used with trial protocol opioid criteria to detect treatment response (Cohen's  = 0.71).

Conclusion: Use of daily over weekly ratings delivered no added benefit in evaluating pain in this clinical trial. This study is the first to compare weekly and daily recall to measure pain as an endpoint in a randomized phase 3 drug trial, and the pattern of differences in ratings that we observed is consistent with other recent evaluations of weekly and daily symptom reporting.
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http://dx.doi.org/10.1177/17407745211009547DOI Listing
April 2021

The development and initial validation of the Breast Cancer Recurrence instrument (BreastCaRe)-a patient-reported outcome measure for detecting symptoms of recurrence after breast cancer.

Qual Life Res 2021 Apr 16. Epub 2021 Apr 16.

Psychological Aspects of Cancer, Danish Cancer Society Research Center, Strandboulevarden 49, 2100, Copenhagen, Denmark.

Purpose: Patient-reported outomes (PRO) may facilitate prompt treatment. We describe the development and psychometric properties of the first instrument to monitor for symptoms of breast cancer (BC) recurrence.

Methods: This study is nested in the MyHealth randomized trial of nurse-led follow-up based on electronically-collected PROs. We constructed items assessing symptoms of potential recurrence through expert interviews with six BC specialists in Denmark. Semi-structured cognitive interviews were carried out with a patient panel to assess acceptability and comprehensibility. Items were subsequently tested in a population of 1170 women 1-10 years after completing BC treatment. We carried out multiple-groups confirmatory factor analysis (CFA) and Rasch analysis to test dimensionality, local dependence (LD) and differential item functioning (DIF) according to sociodemographic and treatment-related factors. Clinical data was obtained from the Danish Breast Cancer Group registry.

Results: Twenty-two items were generated for the Breast Cancer Recurrence instrument (BreastCaRe). Cognitive testing resulted in clearer items. Seven subscales based on general, bone, liver, lung, brain, locoregional and contralateral recurrence symptoms were proposed. Both CFA and Rasch models confirmed the factor structure. No DIF was identified. Five item pairs showed LD but all items were retained to avoid loss of clinical information. Rasch models taking LD into account were used to generate a standardized scoring table for each subscale.

Conclusions: The BreastCaRe has good content and structural validity, patient acceptability and measurement invariance. We are preparing to examine the predictive validity of this new instrument.
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http://dx.doi.org/10.1007/s11136-021-02841-1DOI Listing
April 2021

Identification of Patient-Reported Outcome Phenotypes Among Oncology Patients With Palliative Care Needs.

JCO Oncol Pract 2021 Mar 24:OP2000849. Epub 2021 Mar 24.

Division of Hematology and Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

Purpose: Despite evidence-based guidelines recommending early palliative care, it remains unclear how to identify and refer oncology patients, particularly in settings with constrained access to palliative care. We hypothesize that patient-reported outcome (PRO) data can be used to characterize patients with palliative care needs. To determine if PRO data can identify latent phenotypes that characterize indications for specialty palliative care referral.

Methods: We conducted a retrospective study of self-reported symptoms on the Edmonton Symptom Assessment System collected from solid tumor oncology patients (n = 745) referred to outpatient palliative care. Data were collected as part of routine clinical care from October 2012 to March 2018 at eight community and academic sites. We applied latent profile analysis to identify PRO phenotypes and examined the association of phenotypes with clinical and demographic characteristics using multinomial logistic regression.

Results: We identified four PRO phenotypes: (1) Low Symptoms (n = 295, 39.6%), (2) Moderate Pain/Fatigue + Mood (n = 180, 24.2%), (3) Moderate Pain/Fatigue + Appetite + Dyspnea (n = 201, 27.0%), and (4) High Symptoms (n = 69, 9.3%). In a secondary analysis of 421 patients, we found that two brief items assessing social and existential needs aligned with higher severity symptom and psychological distress phenotypes.

Conclusion: Oncology patients referred to outpatient palliative care in a real-world setting can be differentiated into clinically meaningful phenotypes using brief, routinely collected PRO measures. Latent modeling provides a mechanism to use patient-reported data on a population level to identify distinct subgroups of patients with unmet palliative needs.
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http://dx.doi.org/10.1200/OP.20.00849DOI Listing
March 2021

Measuring Goal-Concordant Care in Palliative Care Research.

J Pain Symptom Manage 2021 Mar 3. Epub 2021 Mar 3.

Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill; Division of Geriatric Medicine and Palliative Care Program, University of North Carolina at Chapel Hill.

Goal-concordant care is a priority outcome for palliative care research, yet the field lacks consensus on optimal methods for measurement. We sought to (1) categorize methods used to measure goal-concordant care, and (2) discuss strengths and limitations of each method using empirical examples from palliative care research. We categorized measurement methods for goal-concordant care. We identified empirical examples of each method to illustrate the strengths, limitations, and applicability of each method to relevant study designs. We defined four methods used to measure goal-concordant care: (1) Patient- or Caregiver-Reported, (2) Caregiver-Reported After Death, (3) Concordance in Longitudinal Data, and (4) Population-Level Indicators. Patient or caregiver-reported goal-concordant care draws on strengths of patient-reported outcomes, and can be captured for multiple aspects of treatment; these methods are subject to recall bias or family-proxy bias. Concordance in longitudinal data is optimal when a treatment preference can be specifically and temporally linked to actual treatment; the method is limited to common life-sustaining treatment choices and validity may be affected by temporal variation between preference and treatment. Population-level indicators allow pragmatic research to include large populations; its primary limitation is the assumption that preferences held by a majority of persons should correspond to patterns of actual treatment in similar populations. Methods used to measure goal-concordant care have distinct strengths and limitations, and methods should be selected based on research question and study design. Existing methods could be improved, yet a future gold standard is unlikely to suit all research designs.
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http://dx.doi.org/10.1016/j.jpainsymman.2021.02.030DOI Listing
March 2021

The usefulness of the Electronic Patient Visit Assessment (ePVA) as a clinical support tool for real-time interventions in head and neck cancer.

Mhealth 2021 20;7. Epub 2021 Jan 20.

Fox Chase Cancer Center, Philadelphia, PA, USA.

Background: Patients with head and neck cancer (HNC) experience painful, debilitating symptoms and functional limitations that can interrupt cancer treatment, and decrease their health-related quality of life (HRQoL). The Electronic Patient Visit Assessment (ePVA) for head and neck is a web-based mHealth patient-reported measure that asks questions about 21 categories of symptoms and functional limitations common to HNC. This article presents the development and usefulness of the ePVA as a clinical support tool for real-time interventions for patient-reported symptoms and functional limitations in HNC.

Methods: Between January 2018 and August 2019, 75 participants were enrolled in a clinical usefulness study of the ePVA. Upon signing informed consent, participants completed the ePVA and the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) general (C30) questionnaire v3.0 (scores range from 0 to 100 with 100 representing best HRQoL). Clinical usefulness of the ePVA was defined as demonstration of reliability, convergent validity with HRQoL, and acceptability of the ePVA (i.e., >70% of eligible participants complete the ePVA at two or more visits and >70% of ePVA reports are read by providers). Formal focus group discussions with the interdisciplinary team that cared for patients with HNC guided the development of the ePVA as a clinical support tool. Qualitative and quantitative methods were used throughout the study. Descriptive statistics consisting of means and frequencies, Pearson correlation coefficient, and Student's t-tests were calculated using SAS 9.4 and STATA.

Results: The participants were primarily male (71%), White (76%), diagnosed with oropharyngeal or oral cavity cancers (53%), and undergoing treatment for HNC (69%). Data analyses supported the reliability (alpha =0.85), convergent validity with HRQoL scores, and acceptability of the ePVA. Participants with the highest number of symptoms and functional limitations reported significantly worse HRQoL (sum of symptoms: r=-0.50, P<0.0001; sum of function limitations: r=-0.56, P<0.0001). Ninety-two percent of participants (59 of 64) who had follow-up visits within the 6-month study period completed the ePVA at two or more visits and providers read 89% (169 of 189) of automated ePVA reports. The use of the ePVA as a clinical support tool for real-time interventions for symptoms and functional limitations reported by patients is described in a clinical exemplar.

Conclusions: This research indicates that the ePVA may be a useful mHealth tool as a clinical support tool for real-time interventions for patient-reported symptoms and functional limitations in HNC. The study findings support future translational research to enhance the usefulness of the ePVA in real world settings for early interventions that decrease symptom burden and improve the QoL of patients with HNC.
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http://dx.doi.org/10.21037/mhealth-19-250DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7882269PMC
January 2021

Development of integration indexes to determine the extent of family planning and child immunization services integration in health facilities in urban areas of Nigeria.

Reprod Health 2021 Feb 23;18(1):47. Epub 2021 Feb 23.

University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Background: Integrating family planning into child immunization services may address unmet need for contraception by offering family planning information and services to postpartum women during routine child immunization visits. However, policies and programs promoting integration are often based on insubstantial or conflicting evidence about its effects on service delivery and health outcomes. While integration models vary, many studies measure integration as binary (a facility is integrated or not) rather than a multidimensional and varying continuum. It is thus challenging to ascertain the determinants and effects of integrated service delivery. This study creates Facility and Provider Integration Indexes, which measure capacity to support integrated family planning and child immunization services and applies them to analyze the extent of integration across 400 health facilities.

Methods: This study utilizes cross-sectional health facility (N = 400; 58% hospitals, 42% primary healthcare centers) and healthcare provider (N = 1479) survey data that were collected in six urban areas of Nigeria for the impact evaluation of the Nigerian Urban Reproductive Health Initiative. Principal Component Analysis was used to develop Provider and Facility Integration Indexes that estimate the extent of integration in these health facilities. The Provider Integration Index measures provider skills and practices that support integrated service delivery while the Facility Integration Index measures facility norms that support integrated service delivery. Index scores range from zero (low) to ten (high).

Results: Mean Provider Integration Index score is 5.42 (SD 3.10), and mean Facility Integration Index score is 6.22 (SD 2.72). Twenty-three percent of facilities were classified as having low Provider Integration scores, 32% as medium, and 45% as high. Fourteen percent of facilities were classified as having low Facility Integration scores, 38% as medium, and 48% as high.

Conclusion: Many facilities in our sample have achieved high levels of integration, while many others have not. Results suggest that using more nuanced measures of integration may (a) more accurately reflect true variation in integration within and across health facilities, (b) enable more precise measurement of the determinants or effects of integration, and (c) provide more tailored, actionable information about how best to improve integration. Overall, results reinforce the importance of utilizing more nuanced measures of facility-level integration.
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http://dx.doi.org/10.1186/s12978-021-01105-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7903768PMC
February 2021

Association of step count with PROMIS pediatric health-related quality of life measures in children and adolescents with persistent asthma.

J Allergy Clin Immunol Pract 2021 Feb 16. Epub 2021 Feb 16.

Department of Population Health Sciences, Duke University School of Medicine, Durham, NC; Department of Pediatrics, Duke University School of Medicine, Durham, NC.

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http://dx.doi.org/10.1016/j.jaip.2021.01.046DOI Listing
February 2021

Composite grading algorithm for the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

Clin Trials 2021 Feb 1;18(1):104-114. Epub 2020 Dec 1.

Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ, USA.

Background: The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events is an item library designed for eliciting patient-reported adverse events in oncology. For each adverse event, up to three individual items are scored for frequency, severity, and interference with daily activities. To align the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events with other standardized tools for adverse event assessment including the Common Terminology Criteria for Adverse Events, an algorithm for mapping individual items for any given adverse event to a single composite numerical grade was developed and tested.

Methods: A five-step process was used: (1) All 179 possible Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events score combinations were presented to 20 clinical investigators to subjectively map combinations to single numerical grades ranging from 0 to 3. (2) Combinations with <75% agreement were presented to investigator committees at a National Clinical Trials Network cooperative group meeting to gain majority consensus via anonymous voting. (3) The resulting algorithm was refined via graphical and tabular approaches to assure directional consistency. (4) Validity, reliability, and sensitivity were assessed in a national study dataset. (5) Accuracy for delineating adverse events between study arms was measured in two Phase III clinical trials (NCT02066181 and NCT01522443).

Results: In Step 1, 12/179 score combinations had <75% initial agreement. In Step 2, majority consensus was reached for all combinations. In Step 3, five grades were adjusted to assure directional consistency. In Steps 4 and 5, composite grades performed well and comparably to individual item scores on validity, reliability, sensitivity, and between-arm delineation.

Conclusion: A composite grading algorithm has been developed and yields single numerical grades for adverse events assessed via the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, and can be useful in analyses and reporting.
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http://dx.doi.org/10.1177/1740774520975120DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7878323PMC
February 2021

Clinical Utility and User Perceptions of a Digital System for Electronic Patient-Reported Symptom Monitoring During Routine Cancer Care: Findings From the PRO-TECT Trial.

JCO Clin Cancer Inform 2020 10;4:947-957

Mayo Clinic, Scottsdale, AZ.

Purpose: There is increasing interest in implementing digital systems for remote monitoring of patients' symptoms during routine oncology practice. Information is limited about the clinical utility and user perceptions of these systems.

Methods: PRO-TECT is a multicenter trial evaluating implementation of electronic patient-reported outcomes (ePROs) among adults with advanced and metastatic cancers receiving treatment at US community oncology practices (ClinicalTrials.gov identifier: NCT03249090). Questions derived from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) are administered weekly by web or automated telephone system, with alerts to nurses for severe or worsening symptoms. To elicit user feedback, surveys were administered to participating patients and clinicians.

Results: Among 496 patients across 26 practices, the majority found the system and questions easy to understand (95%), easy to use (93%), and relevant to their care (91%). Most patients reported that PRO information was used by their clinicians for care (70%), improved discussions with clinicians (73%), made them feel more in control of their own care (77%), and would recommend the system to other patients (89%). Scores for most patient feedback questions were significantly positively correlated with weekly PRO completion rates in both univariate and multivariable analyses. Among 57 nurses, most reported that PRO information was helpful for clinical documentation (79%), increased efficiency of patient discussions (84%), and was useful for patient care (75%). Among 39 oncologists, most found PRO information useful (91%), with 65% using PROs to guide patient discussions sometimes or often and 65% using PROs to make treatment decisions sometimes or often.

Conclusion: These findings support the clinical utility and value of implementing digital systems for monitoring PROs, including the PRO-CTCAE, in routine cancer care.
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http://dx.doi.org/10.1200/CCI.20.00081DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7768331PMC
October 2020

Applying patient-reported outcome methodology to capture patient-reported health data: Report from an NIH Collaboratory roundtable.

Healthc (Amst) 2020 Sep 16;8(3):100442. Epub 2020 Jul 16.

University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Duke Clinical Research Institute, USA; Population Health Sciences, USA; Duke University School of Medicine, Durham, NC, USA. Electronic address:

Patient-reported health data provide information for pragmatic clinical trials that may not be readily available from electronic health records or administrative claims data. In this report, we present key considerations for collecting patient-reported health information in pragmatic clinical trials, which are informed by best practices from patient-reported outcome research. We focus on question design and administration via electronic data collection platforms with respect to 3 types of patient-reported health data: medication use, utilization of health care services, and comorbid conditions. We summarize key scientific literature on the accuracy of these patient-reported data compared with electronic health record data. We discuss question design in detail, specifically defining the concept to be measured, patient understanding of the concept, recall periods of the question, and patient willingness to report. In addition, we discuss approaches for question administration and data collection platforms, which are key aspects of successful patient-reported data collection.
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http://dx.doi.org/10.1016/j.hjdsi.2020.100442DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8018605PMC
September 2020

Feasibility and delivery of patient-reported outcomes in clinical practice among racially diverse bladder and prostate cancer patients.

Urol Oncol 2021 01 17;39(1):77.e1-77.e8. Epub 2020 Aug 17.

University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, NC; University of North Carolina, Lineberger Comprehensive Cancer Center, Biostatistics Core, Chapel Hill, NC; University of Kansas, Department of Radiation Oncology, Kansas City, KS.

Objective: To assess the feasibility of enrollment and collecting patient-reported outcome (PRO) data as part of routine clinical urologic care for bladder and prostate cancer patients and examine overall patterns and racial variations in PRO use and symptom reports over time.

Subjects/patients And Methods: We recruited 76 patients (n = 29 Black and n = 47 White) with prostate or bladder cancer at a single, comprehensive cancer center. The majority of prostate cancer patients had intermediate risk (57%) disease and underwent either radiation or prostatectomy. Over half (58%) of bladder cancer patients had muscle invasive disease and underwent cystectomy. Patients were asked to complete PRO symptom surveys using their preferred mode [web- or phone-based interactive voice response (IVR)]. Symptom summary reports were shared with providers during visits. Surveys were completed at 3 time points and assessed urinary, sexual, gastrointestinal, anxiety/depression, and sleep symptoms. Feasibility of enrollment and survey completion were calculated, and linear mixed effects models estimated differences in outcomes by race and time.

Results: Sixty three percent of study participants completed all PRO measures at all 3 time points. Black patients were more likely to select IVR as their survey mode (40% vs. 13%, P < 0.05), and less likely to complete all surveys (55% vs. 74%, P = 0.13). Patients using IVR were also less likely to complete all surveys (41% vs. 69%, P = 0.046).

Conclusions: Reported preferences for survey mode and completion rates differ by race, which may influence survey completion rates and highlight potential obstacles for equitable implementation of PROs into clinical care.
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http://dx.doi.org/10.1016/j.urolonc.2020.06.030DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7736202PMC
January 2021

Selecting Outcomes to Ensure Pragmatic Trials Are Relevant to People Living with Dementia.

J Am Geriatr Soc 2020 Jul;68 Suppl 2:S55-S61

Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

Outcome measures for embedded pragmatic clinical trials (ePCTs) should reflect the lived experience of people living with dementia (PLWD) and their caregivers, yet patient- and caregiver-reported outcomes (PCROs) are rarely available in large clinical and administrative data sources. Although pragmatic methods may lead to use of existing administrative data rather than new data collected directly from PLWD, interventions are truly impactful only when they change outcomes prioritized by PLWD and their caregivers. The Patient- and Caregiver-Reported Outcomes Core (PCRO Core) of the IMbedded Pragmatic Alzheimer's Disease (AD) and AD-Related Dementias Clinical Trials (IMPACT) Collaboratory aims to promote optimal use of outcomes relevant to PLWD and their caregivers in pragmatic trials. The PCRO Core will address key scientific challenges limiting outcome measurement, such as gaps in existing measures, methodologic constraints, and burdensome data capture. PCRO Core investigators will create a searchable library of AD/AD-related dementias (ADRD) clinical outcome measures, including measures in existing data sources with potential for AD/ADRD ePCTs, and will support best practices in measure development, including pragmatic adaptation of PCROs. Working together with other Cores and Teams within the IMPACT Collaboratory, the PCRO Core will support investigators to select from existing outcome measures, and to innovate in methods for measurement and data capture. In the future, the work of the IMPACT Collaboratory may galvanize broader embedded use of outcomes that matter to PLWD and their care partners in large health systems. J Am Geriatr Soc 68:S55-S61, 2020.
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http://dx.doi.org/10.1111/jgs.16619DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7469944PMC
July 2020

Associations between prostate cancer-related anxiety and health-related quality of life.

Cancer Med 2020 06 23;9(12):4467-4473. Epub 2020 Apr 23.

Lineberger Comprehensive Cancer Center, School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Background: There are uncertainties about prostate cancer-related anxiety's (PCRA) associations with health-related quality of life (HRQOL) and major depression, and these could affect the quality of mental healthcare provided to prostate cancer patients. Addressing these uncertainties will provide more insight into PCRA and inform further research on the value of PCRA prevention. The goals of this study were to measure associations between PCRA and HRQOL at domain and subdomain levels, and to evaluate the association between PCRA and probable (ie, predicted major) depression.

Method: We analyzed secondary cross-sectional data from the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS-a population-based cohort of prostate cancer patients enrolled shortly after diagnosis [between January 2011 and June 2013] and followed prospectively). Patient-reported measures of PCRA and HRQOL from 1,016 enrollees who participated in NC ProCESS's 1-year follow-up survey were assessed. Outcomes of interests were a) linear correlations between contemporaneous memorial anxiety scale for prostate cancer (MAX-PC) and Short Form 12 (SF-12) scores, and b) measures of association between indicators of clinically significant PCRA (ie, MAX-PC > 27) and probable depression during survey contact (ie, SF-12 mental component score ≤43).

Results: PCRA measures had notable associations with SF-12's mental health subscale (assesses low mood/nervousness [rho = -0.42]) and emotional role functioning subscale (assesses subjective productivity loss [rho = -0.46]). Additionally, the risk of probable depression was significantly higher in participants with clinically significant PCRA compared with those without it (weighed risk ratio = 5.3, 95% confidence interval 3.6-7.8; P < .001).

Conclusion: Prostate cancer patients with clinically significant PCRA should be assessed for major depression and productivity loss.
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http://dx.doi.org/10.1002/cam4.3069DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7300422PMC
June 2020

Psychometric properties of the FACT-G quality of life scale for family caregivers of cancer patients.

Qual Life Res 2020 Aug 3;29(8):2241-2252. Epub 2020 Apr 3.

School of Nursing, University of Michigan-Ann Arbor, Ann Arbor, MI, USA.

Purpose: This study aimed to examine psychometric properties of a caregiver version of the well-established Functional Assessment of Cancer Therapy-General Scale (FACT-G) after conducting focus groups and obtaining expert input.

Methods: We made minor wording modifications to the Patient FACT-G to enable caregivers to report how the illness affected their overall quality of life (QOL) and well-being on four subscales (physical, social, emotional, functional). We tested the acceptability, precision, factor structure, reliability and validity of the Caregiver FACT-G among partners of prostate cancer patients (N = 263) and caregivers (spouses, siblings, adult children) of patients with advanced cancer (breast, lung, colorectal, prostate) (N = 484) using data from two Randomized Clinical Trials (RCTs).

Results: With a factor structure similar to the Patient FACT-G, Caregiver FACT-G was acceptable and precise in measuring caregiver QOL, with high inter-factor correlations and internal consistency reliability (Cronbach's alphas 0.81-0.91). The Caregiver FACT-G had strong convergent validity demonstrated by significant positive correlations with caregiver self-efficacy (0.25-0.63), dyadic communication (0.18-0.51), and social support (0.18-0.54) in both samples. It also had strong discriminant validity evidenced by significant inverse correlations with negative appraisal of caregiving (- 0.37 to - 0.69), uncertainty (- 0.28 to - 0.53), hopelessness (- 0.25 to - 0.60), and avoidant coping (- 0.26 to - 0.58) in both samples. Caregivers' baseline FACT-G scores were significantly associated with their physical (0.23) and mental well-being (0.54; 4-month follow-up) and their depression (- 0.69; 3-month follow-up), indicating strong predictive validity.

Conclusion: This is the first study evaluating the psychometric properties of the Caregiver FACT-G. More psychometric testing is warranted, especially among caregivers of diverse sociocultural backgrounds.
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http://dx.doi.org/10.1007/s11136-020-02477-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7363734PMC
August 2020

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

Qual Life Res 2020 Feb 28. Epub 2020 Feb 28.

Department of Population Health Sciences, Department of Pediatrics, and Duke Cancer Institute, Duke University School of Medicine, Duke University, 215 Morris Street, Room 230, Durham, NC, 27701, USA.

Purpose: Electronic patient-reported outcomes (ePROs) are increasingly being used for symptom monitoring during routine cancer care, but have rarely been evaluated in diverse patient populations. We assessed ePRO user experiences and perceived value among Black and White cancer patients.

Methods: We recruited 30 Black and 49 White bladder and prostate cancer patients from a single institution. Participants reported symptoms using either a web-based or automated telephone interface over 3 months and completed satisfaction surveys and qualitative interviews focused on user experiences and value. Using a narrative mixed methods approach, we evaluated overall and race-specific differences in ePRO user experiences and perceived value.

Results: Most participants selected the web-based system, but Blacks were more likely to use the automated telephone-based system than Whites. In satisfaction surveys, Whites more commonly reported ease in understanding and reporting symptoms compared with Blacks. Blacks more often reported that the ePRO system was helpful in facilitating symptom-related discussions with clinicians. During interviews, Blacks described how the ePRO helped them recognize symptoms, while Whites found value in better understanding and tracking symptoms longitudinally. Blacks also expressed preferences for paper-based ePRO options due to perceived ease in better understanding of symptom items.

Conclusion: Electronic patient-reported outcomes are perceived as valuable for variable reasons by Black and White cancer populations, with greater perceived value for communicating with clinicians reported among Blacks. To optimize equitable uptake of ePROs, oncology practices should offer several ePRO options (e.g., web-based, phone-based), as well as paper-based options, and consider the e-health literacy needs of patients during implementation.
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http://dx.doi.org/10.1007/s11136-020-02442-4DOI Listing
February 2020

Performance Measures Based on How Adults With Cancer Feel and Function: Stakeholder Recommendations and Feasibility Testing in Six Cancer Centers.

JCO Oncol Pract 2020 03 19;16(3):e234-e250. Epub 2020 Feb 19.

Department of Health Policy and Management, University of North Carolina at Chapel Hill, Chapel Hill, NC.

Purpose: Patient-reported outcome measures (PROMs) that assess how patients feel and function have potential for evaluating quality of care. Stakeholder recommendations for PRO-based performance measures (PMs) were elicited, and feasibility testing was conducted at six cancer centers.

Methods: Interviews were conducted with 124 stakeholders to determine priority symptoms and risk adjustment variables for PRO-PMs and perceived acceptability. Stakeholders included patients and advocates, caregivers, clinicians, administrators, and thought leaders. Feasibility testing was conducted in six cancer centers. Patients completed PROMs at home 5-15 days into a chemotherapy cycle. Feasibility was operationalized as ≥ 75% completed PROMs and ≥ 75% patient acceptability.

Results: Stakeholder priority PRO-PMs for systemic therapy were GI symptoms (diarrhea, constipation, nausea, vomiting), depression/anxiety, pain, insomnia, fatigue, dyspnea, physical function, and neuropathy. Recommended risk adjusters included demographics, insurance type, cancer type, comorbidities, emetic risk, and difficulty paying bills. In feasibility testing, 653 patients enrolled (approximately 110 per site), and 607 (93%) completed PROMs, which indicated high feasibility for home collection. The majority of patients (470 of 607; 77%) completed PROMs without a reminder call, and 137 (23%) of 607 completed them after a reminder call. Most patients (72%) completed PROMs through web, 17% paper, or 2% interactive voice response (automated call that verbally asked patient questions). For acceptability, > 95% of patients found PROM items to be easy to understand and complete.

Conclusion: Clinicians, patients, and other stakeholders agree that PMs that are based on how patients feel and function would be an important addition to quality measurement. This study also shows that PRO-PMs can be feasibly captured at home during systemic therapy and are acceptable to patients. PRO-PMs may add value to the portfolio of PMs as oncology transitions from fee-for-service payment models to performance-based care that emphasizes outcome measures.
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http://dx.doi.org/10.1200/JOP.19.00784DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7069703PMC
March 2020

A review of Kenya's cancer policies to improve access to cancer testing and treatment in the country.

Health Res Policy Syst 2020 Jan 7;18(1). Epub 2020 Jan 7.

Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, United States of America.

Background: Cancer is the third-leading cause of mortality in Kenya, resulting in unique challenges to the country's health system. An increase in the number of cancer cases in Kenya over the past decade resulted in legislative actions and policies to guide delivery of cancer services. Kenya's new national cancer control strategy and past policy efforts provide an opportunity to synergise information and enhance understanding to improve cancer diagnosis and treatment in the country. The objectives of this study are to (1) document policy-modifiable factors based on a review of policy documents and results of a key informant survey and (2) develop recommendations to improve policies affecting cancer testing and treatment services in Kenya. This study builds upon our previous study Improving Access to Cancer Testing and Treatment in Kenya (Makau Barasa et al. J Global Oncol 2(216), 2017).

Methods: The study applied an in-depth systematic review of Kenya's cancer policies and guidelines, a qualitative analysis of results from a section of a semi-structured key informant survey focused on the opinions of clinicians delivering cancer services as well as cancer support groups and advocacy leaders, and a stakeholder analysis identifying key policy-makers and implementers. Details of the complete key informant survey were published in our previous study.

Results: Kenya's cancer policies have guided progress made in providing the legal and implementation frameworks for the development and delivery of cancer services at the national and county levels. Some policy implementation gaps are noted. These include inadequate financing for cancer services, limited research and data to support policy formulation, and the concentration of cancer services in urban areas. The key informant survey identified policy-modifiable actions that can address some of the gaps and improve the delivery of and access to cancer testing and treatment services in the country. Some of these include addressing the financial barriers affecting cancer testing and treatment services; increasing stakeholder engagement in training health personnel to deliver cancer testing and treatment services; decentralising cancer services and improving cancer surveillance and research; and increasing education and awareness about cancer symptoms, screening procedures and treatment options. A set of priority policy actions were selected from the study findings and used to develop recommendations for Kenya's policy-makers and stakeholders.

Conclusions: Revisions to Kenya's cancer policies are seeking to address gaps noted in past policies and to improve access to cancer testing and treatment in Kenya. However, based on study findings, additional actions can be taken to strengthen policy implementation. Considering the policy formulation and implementation process and costs, this study recommends focusing on three priority policy actions that can have significant impact on improving access to cancer testing and treatment services. These include addressing financing, insurance and human resources gaps; increasing stakeholder engagement; and decentralising health services for better surveillance and data to inform policies.
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http://dx.doi.org/10.1186/s12961-019-0506-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6947983PMC
January 2020

Does Receipt of Recommended Elements of Palliative Care Precede In-Hospital Death or Hospice Referral?

J Pain Symptom Manage 2020 04 10;59(4):778-786. Epub 2019 Dec 10.

Department of Health Policy and Management, University of North Carolina, Chapel Hill, North Carolina, USA.

Context: Palliative care aligns treatments with patients' values and improves quality of life, yet whether receipt of recommended elements of palliative care is associated with end-of-life outcomes is understudied.

Objectives: To assess whether recommended elements of palliative care (pain and symptom management, goals of care, and spiritual care) precede in-hospital death and hospice referral and whether delivery by specialty palliative care affects that relationship.

Methods: We conducted structured chart reviews for decedents with late-stage cancer, dementia, and chronic kidney disease with a hospital admission during the six months preceding death. Measures included receipt of recommended elements of palliative care delivered by any clinician and specialty palliative care consult. We assessed associations between recommended elements of palliative care and in-hospital death and hospice referral using multivariable Poisson regression models.

Results: Of 402 decedents, 67 (16.7%) died in hospital, and 168 (41.8%) had hospice referral. Among elements of palliative care, only goals-of-care discussion was associated with in-hospital death (incidence rate ratio [IRR] 1.37; 95% CI 1.01-1.84) and hospice referral (IRR 1.85; 95% CI 1.31-2.61). Specialty palliative care consult was associated with a lower likelihood of in-hospital death (IRR 0.57; 95% CI 0.44-0.73) and a higher likelihood of hospice referral (IRR 1.45; 95% CI 1.12-1.89) compared with no consult.

Conclusion: Goals-of-care discussions by different types of clinicians commonly precede end-of-life care in hospital or hospice. However, engagement with specialty palliative care reduced in-hospital death and increased hospice referral. Understanding the causal pathways of goals-of-care discussions may help build primary palliative care interventions to support patients near the end of life.
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http://dx.doi.org/10.1016/j.jpainsymman.2019.11.011DOI Listing
April 2020

Elements of Palliative Care in the Last 6 Months of Life: Frequency, Predictors, and Timing.

J Gen Intern Med 2020 03 24;35(3):753-761. Epub 2019 Oct 24.

Department of Health Policy and Management, University of North Carolina, Chapel Hill, NC, USA.

Importance: Persons living with serious illness often need skilled symptom management, communication, and spiritual support. Palliative care addresses these needs and may be delivered by either specialists or clinicians trained in other fields. It is important to understand core elements of palliative care to best provide patient-centered care.

Objective: To describe frequency, predictors, and timing of core elements of palliative care during the last 6 months of life.

Design: Retrospective chart review.

Setting: Inpatient academic medical center.

Participants: Decedents with cancer, dementia, or chronic kidney disease (CKD) admitted during the 6 months preceding death.

Exposures: We identified receipt and timing of core elements of palliative care: pain and symptom management, goals of care, spiritual care; and specialty palliative care utilization; hospital encounters; demographics; and comorbid diagnoses. We ran Poisson regression models to assess whether diagnosis or hospital encounters were associated with core elements of palliative care.

Results: Among 402 decedents, the mean (SD) number of appropriately screened and treated symptoms was 2.9 (1.7)/10. Among 76.1% with documented goals of care, 58.0% had a primary goal of comfort; 55.0% had documented spiritual care. In multivariable models, compared with decedents with cancer, those with dementia or CKD were less likely to have pain and symptom management (respectively, 31% (incidence rate ratio [IRR], 0.69; 95% CI, 0.56-0.85) and 17% (IRR, 0.83; CI, 0.71-0.97)). There was a median of 3 days (IQR, 0-173) between transition to a goal of comfort and death, and a median of 12 days (IQR, 5-47) between hospice referral and death.

Conclusions And Relevance: Although a high proportion of patients received elements of palliative care, transitions to a goal of comfort or hospice happened very near death. Palliative care delivery can be improved by systematizing existing mechanisms, including prompts for earlier goals-of-care discussion, symptom screening, and spiritual care, and by building collaboration between primary and specialty palliative care services.
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http://dx.doi.org/10.1007/s11606-019-05349-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7080876PMC
March 2020

Assessment of Adverse Events From the Patient Perspective in a Phase 3 Metastatic Castration-Resistant Prostate Cancer Clinical Trial.

JAMA Oncol 2020 02 13;6(2):e193332. Epub 2020 Feb 13.

Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill.

Importance: Standard adverse event (AE) reporting in oncology clinical trials has historically relied on clinician grading, which prior research has shown can lead to underestimation of rates of symptomatic AEs. Industry sponsors are beginning to implement in trials the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), which was developed to allow patients to self-report symptomatic AEs and improve the quality of symptomatic AE detection.

Objectives: To evaluate the feasibility of implementing PRO-CTCAE in a prespecified correlative analysis of the phase 3 COMET-2 trial and enumerate statistically significant between-group differences in symptomatic AEs using PRO-CTCAE and the CTCAE.

Design, Setting, And Participants: This correlative study of 119 men in the randomized, double-blind, placebo-controlled phase 3 COMET-2 trial with metastatic castration-resistant prostate cancer who had undergone at least 2 prior lines of systemic treatment was conducted from March 2012 to July 2014. Participants completed PRO-CTCAE items using an automated telephone system from home prior to treatment and every 3 weeks during treatment. Statistical analysis was performed from May 2018 to June 2019.

Main Outcomes And Measures: The proportion of patients who completed expected PRO-CTCAE self-reports was computed as a measure of feasibility.

Results: Among the 119 men in the study (median age, 65 years [range, 44-80 years]), 534 of 587 (91.0%) expected PRO-CTCAE self-reports were completed, with consistently high rates of completion throughout participation. Rates of self-report adherence were similar between groups (cabozantinib s-maleate, 286 of 317 [90.2%]; and mitoxantrone hydrochloride-prednisone, 248 of 270 [91.9%]). Of 12 measured, patient-reported PRO-CTCAE symptomatic AEs, 4 reached statistical significance when comparing the proportion of patients with at least 1 postbaseline score greater than 0 between groups (differences ranged from 20.1% to 34.1% with higher proportions in the cabozantinib group; all P < .05), and use of a method for accounting for preexisting symptoms at baseline yielded 7 AEs with statistically significant differences between groups (differences ranged from 20.5% to 41.2% with higher proportions in the cabozantinib group; all P < .05). In the same analysis using investigator-reported CTCAE data, no statistically significant differences were found between groups for any symptomatic AEs.

Conclusions And Relevance: PRO-CTCAE data collection was feasible and improved the accuracy of symptomatic AE detection in a phase 3 cancer trial. This analysis adds to mounting evidence of the feasibility and value of patient-reported AEs in oncology, which should be considered for inclusion in cancer trials that incorporate AE evaluation.

Trial Registration: ClinicalTrials.gov identifier: NCT01522443.
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http://dx.doi.org/10.1001/jamaoncol.2019.3332DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6764147PMC
February 2020

The development, usability, and reliability of the Electronic Patient Visit Assessment (ePVA) for head and neck cancer.

Mhealth 2019 29;5:21. Epub 2019 Jul 29.

Fox Chase Cancer Center, Philadelphia, PA, USA.

Background: Annually, over 65,000 persons are diagnosed with head and neck cancer in the United States. During treatment, up to 50% of patients become severely symptomatic with pain, fatigue, mouth sores, and inability to eat. Long term complications are lymphedema, fibrosis, dysphagia, and musculoskeletal impairment. Patients' ability to perform daily activities and to interact socially may be impaired, resulting in poor quality of life. A pragmatic, clinically useful assessment is needed to ensure early detection and intervention for patients to report symptoms and functional limitations over time. We developed the Electronic Patient Visit Assessment (ePVA) that enables patients to report 42 symptoms related to head and neck cancer and 17 limitations of functional status. This manuscript reports (I) the development of the ePVA, (II) the content validity of the ePVA, and (III) the usability and reliability of the ePVA.

Methods: Usability was evaluated using the "Think Aloud" technique to guide the iterative process to refine the ePVA based on participants' evaluations. After signing the informed consent, 30 participants with head and neck cancer completed the ePVA using digital tablet devices while thinking aloud about ease of use. All patient conversations were recorded and professionally transcribed. Reliability of the ePVA symptom and functional limitation measures was estimated using the Kuder-Richardson test. Convergent validity of the ePVA was evaluated using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 global QoL/health scale. Transcribed qualitative data were analyzed using directed content analysis approach. Quantitative analyses consisted of descriptive statistics and correlation analyses.

Results: Among participants, 90% strongly agreed or agreed that the ePVA system was easy to use and 80% were very satisfied. Only minor usability problems were reported due to formatting and software "bugs". Reporting of usability problems decreased in frequency over the study period and no usability problems were reported by the last 3 participants who completed the ePVA. Based on participants' suggestions during the iterative process, refinement of the ePVA included increased touch sensitivity of the touch screen technology and customized error messages to improve ease of use. The ePVA also recorded patient reported symptoms (mouth symptoms: 93%, fibrosis: 60%, fatigue: 60%). The ePVA demonstrated acceptable reliability (alpha =0.82-0.85) and convergent validity (ePVA total number of reported symptoms and function limitations was negatively correlated with EORTC QLQ-C30 global QOL/health scale: r=-0.55038, P<0.01).

Conclusions: The ePVA was rigorously developed, accepted by patients with satisfaction, and demonstrated acceptable reliability and convergent validity. Future research will use data generated by the ePVA to determine the impact of symptom trajectories on functional status, treatment interruptions and terminations, and health resource use in head and neck cancer.
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http://dx.doi.org/10.21037/mhealth.2019.06.05DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6691072PMC
July 2019

Patient-Clinician Decision Making for Stable Angina: The Role of Health Literacy.

EGEMS (Wash DC) 2019 Aug 9;7(1):42. Epub 2019 Aug 9.

Mayo Clinic, US.

Background: Stable angina patients have difficulty understanding the tradeoffs between treatment alternatives. In this analysis, we assessed treatment planning conversations for stable angina to determine whether inadequate health literacy acts as a barrier to communication that may partially explain this difficulty.

Methods: We conducted a descriptive analysis of patient questionnaire data from the PCI Choice Trial. The main outcomes were the responses to the Decisional Conflict Scale and the proportion of correct responses to knowledge questions about stable angina. We also conducted a qualitative analysis on recordings of patient-clinician discussions about treatment planning. The recordings were coded with the OPTION12 instrument for shared decision-making. Two analysts independently assessed the number and types of patient questions and expressions of preferences.

Results: Patient engagement did not differ by health literacy level and was generally low for all patients with respect to OPTION12 scores and the number of questions related to clinical aspects of treatment. Patients with inadequate health literacy had significantly higher decisional conflict. However, the proportion of knowledge questions answered correctly did not differ significantly by health literacy level.

Conclusions: Patients with inadequate health literacy had greater decisional conflict but no difference in knowledge compared to patients with adequate health literacy. Inadequate health literacy may act as a barrier to communication, but gaps were found in patient engagement and knowledge for patients of all health literacy levels. The recorded patient-clinician encounters and the health literacy measure were valuable resources for conducting research on care delivery.
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http://dx.doi.org/10.5334/egems.306DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6688543PMC
August 2019

Electronic Health Record Phenotypes for Identifying Patients with Late-Stage Disease: a Method for Research and Clinical Application.

J Gen Intern Med 2019 12 8;34(12):2818-2823. Epub 2019 Aug 8.

Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina-Chapel Hill, Chapel Hill, NC, USA.

Background: Systematic identification of patients allows researchers and clinicians to test new models of care delivery. EHR phenotypes-structured algorithms based on clinical indicators from EHRs-can aid in such identification.

Objective: To develop EHR phenotypes to identify decedents with stage 4 solid-tumor cancer or stage 4-5 chronic kidney disease (CKD).

Design: We developed two EHR phenotypes. Each phenotype included International Classification of Diseases (ICD)-9 and ICD-10 codes. We used natural language processing (NLP) to further specify stage 4 cancer, and lab values for CKD.

Subjects: Decedents with cancer or CKD who had been admitted to an academic medical center in the last 6 months of life and died August 26, 2017-December 31, 2017.

Main Measure: We calculated positive predictive values (PPV), false discovery rates (FDR), false negative rates (FNR), and sensitivity. Phenotypes were validated by a comparison with manual chart review. We also compared the EHR phenotype results to those admitted to the oncology and nephrology inpatient services.

Key Results: The EHR phenotypes identified 271 decedents with cancer, of whom 186 had stage 4 disease; of 192 decedents with CKD, 89 had stage 4-5 disease. The EHR phenotype for stage 4 cancer had a PPV of 68.6%, FDR of 31.4%, FNR of 0.5%, and 99.5% sensitivity. The EHR phenotype for stage 4-5 CKD had a PPV of 46.4%, FDR of 53.7%, FNR of 0.0%, and 100% sensitivity.

Conclusions: EHR phenotypes efficiently identified patients who died with late-stage cancer or CKD. Future EHR phenotypes can prioritize specificity over sensitivity, and incorporate stratification of high- and low-palliative care need. EHR phenotypes are a promising method for identifying patients for research and clinical purposes, including equitable distribution of specialty palliative care.
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http://dx.doi.org/10.1007/s11606-019-05219-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6854193PMC
December 2019

Pilot randomized trial of an electronic symptom monitoring and reporting intervention for hospitalized adults undergoing hematopoietic stem cell transplantation.

Support Care Cancer 2020 Mar 20;28(3):1223-1231. Epub 2019 Jun 20.

Division of Hematology/Oncology, The University of North Carolina at Chapel Hill, Chapel Hill, USA.

Purpose: Patients undergoing a hematopoietic stem cell transplantation (HCT) have varied symptoms during their hospitalization. This study examined whether daily symptom reporting (with electronic patient-reported outcomes [PROs]) in an inpatient bone marrow transplant clinic reduced symptom burden on post-transplant days +7, +10, and +14.

Methods: A prospective, single-institution 1:1 pilot randomized, two-arm study recruited HCT patients. HCT inpatients (N = 76) reported daily on 16 common symptoms using the PRO version of the Common Terminology for Adverse Events (PRO-CTCAE). Fisher's exact test was used to examine differences in the proportion of patients reporting individual symptoms. Multivariable linear regression modeling was used to examine group differences in peak symptom burden, while controlling for symptom burden at baseline, age, comorbidity, and transplantation type (autologous or allogeneic).

Results: HCT patients receiving the PRO intervention also experienced lower peak symptom burden (average of 16 symptoms) at days +7, +10, and +14 (10.4 vs 14.5, p = 0.03).

Conclusions: Daily use of electronic symptom reporting to nurses in an inpatient bone marrow transplant clinic reduced peak symptom burden and improved individual symptoms during the 2 weeks post-transplant. A multi-site trial is warranted to demonstrate the generalizability, efficacy, and value of this intervention.

Trial Registration: ClinicalTrials.gov identifier: NCT02574897.
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http://dx.doi.org/10.1007/s00520-019-04932-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6923608PMC
March 2020

Usability of PCforMe in Patients With Advanced Cancer Referred to Outpatient Palliative Care: Results of a Randomized, Active-Controlled Pilot Trial.

J Pain Symptom Manage 2019 09 1;58(3):382-389. Epub 2019 Jun 1.

Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA.

Context: Low utilization of palliative care services warrant testing of new solutions to educate and engage patients around the benefits of palliative care.

Objectives: We sought out to develop and test a novel, mobile health solution to prepare patients for an upcoming outpatient palliative care appointment.

Methods: After developing a web-based tool called PCforMe (Palliative Care for Me), we conducted a randomized, active-controlled, trial of PCforMe. The primary outcome was the score on the System Usability Scale (SUS). Secondary outcomes were patient self-efficacy and change in knowledge. We compared PCforMe to three common online resources for patients seeking information about palliative care.

Results: A total of 80 patients were randomized. There were no significant demographic differences. Mean SUS score for PCforMe was 78.2, significantly above the normative average SUS score of 68 (P-value < 0.0001). Mean change in Perceived Efficacy in Patient-Physician Interactions score was -2.2 for PCforMe and -1.7 for control group (P-value = 0.72). Preparedness for an upcoming palliative care visit increased 50% in the intervention group and 13.3% in the control group. Difference in the number of patients with improved knowledge regarding palliative care approached significance (P = 0.06). Lastly, we found that the no-show rate was lower during Q1 2017 (during trial) and Q1 2016 (before trial), at 11.7% and 21%, respectively (P < 0.05). Comparing the full calendar year (CY) 2016 with 2017, we did not find a statistical difference (CY 2016 of 18.8% and 15% in CY 2017; P = 0.22).

Conclusion: PCforMe is a usable mobile health tool to prepare patients for an upcoming palliative care appointment. Further research is needed to test effectiveness.
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http://dx.doi.org/10.1016/j.jpainsymman.2019.05.007DOI Listing
September 2019

Senior Sway: Using a Mobile Application to Measure Fall Risk.

J Geriatr Phys Ther 2019 Jul/Sep;42(3):E101-E107

Cancer Outcomes Research Group, Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill.

Background And Purpose: The Senior Sway mobile application uses the iPhone/iPad gyroscope to assess postural sway and motion reaction time. Impairment in postural sway and motion reaction time have the potential to increase risk for future falls. Senior Sway thereby has the potential to provide a quick, easy to use, objective measure for predicting falls in older adults. The purpose of this study was to evaluate the feasibility of the Senior Sway mobile application and its associations with fall risk in community-dwelling older adults.

Methods: Adults older than 62 years were recruited from senior centers and community events. Descriptive and bivariate statistics were used to examine feasibility on the basis of enrollment, time required, satisfaction with application, and association with fall risk.

Results And Discussion: Fifty-seven adults were recruited. Use of the Senior Sway mobile application was feasible. Ninety-one percent said that they liked the application and reported length of time of assessment was "just right." The average Senior Sway score was 64.0 (range: 47.8-84.0), which was significantly associated with the 30-second sit-to-stand test. In addition, the motor reaction time score was associated with the Timed Up and Go.

Conclusions: Senior Sway is a promising application to improve identification of adults at risk for falls and need for rehabilitation but warrants further research.
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http://dx.doi.org/10.1519/JPT.0000000000000223DOI Listing
April 2020

Using Stakeholder Engagement to Overcome Barriers to Implementing Patient-reported Outcomes (PROs) in Cancer Care Delivery: Approaches From 3 Prospective Studies.

Med Care 2019 05;57 Suppl 5 Suppl 1:S92-S99

Department of Health Policy and Management.

Introduction: Patient-reported outcome (PRO) measures used during cancer care delivery improve communication about symptoms between patients and clinicians and reduce service utilization for uncontrolled symptoms. However, uptake of PROs in routine cancer care has been slow. In this paper, we describe stakeholder engagement activities used to overcome barriers to implementing PROs. Implementation occurred in 2 study settings: PROs completed in the waiting room and reviewed during clinical visits to guide symptom management for multiple myeloma (visit-based PROs); and weekly PROs completed by cancer patients between chemotherapy visits to monitor symptoms at home (remote PROs).

Methods: PRO implementation steps across studies included: (1) clinician and patient input on key symptoms, PRO measures, and identifying which PRO responses are clinically concerning to better target nursing actions; (2) developing PRO-based clinical decision support (CDS) for responding to concerning PROs; (3) training clinicians and clinical research assistants to interpret PROs and use software; and (4) describing implementation impact (frequency of concerning PRO responses and nursing actions).

Discussion: Clinician and patient input was critical for identifying key symptoms, PRO measures, and clinically concerning response options. For the visit-based PRO observational study, all symptom scores appeared on a clinician dashboard, and those rated ≥1 by patients (on a 0-4 or 0-10 scale) had PRO-based CDS available for access. For the 2 remote PROs trials, stakeholders recommended that the 2 "worst" response options (eg, PRO responses of "often"/"always" or "severe"/"very severe") would trigger an automated email alert to a nurse along with PRO-based CDS. In each study, PRO-based CDS was tailored based on clinician input. Across studies, the most common nursing response to concerning PROs was counseling patients on (or providing care plans for) self-management of symptoms. In the trials, the percentage of weekly remote PROs generating an alert to a nurse ranged from 13% at an academic center to 36% in community oncology practices.

Key Points: Across 3 prospective studies, PROs implemented into cancer care enabled tailored care based on issues identified on PROs. Stakeholder engagement was critical for successful implementation. This paper assists in addressing important PRO implementation challenges by describing a stakeholder-driven approach.
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http://dx.doi.org/10.1097/MLR.0000000000001103DOI Listing
May 2019

The COMET (Comparison of Operative versus Monitoring and Endocrine Therapy) trial: a phase III randomised controlled clinical trial for low-risk ductal carcinoma in situ (DCIS).

BMJ Open 2019 03 12;9(3):e026797. Epub 2019 Mar 12.

Department of Medicine, Brigham and Women's Hospital, Dana Farber Cancer Institute, Boston, Massachusetts, USA.

Introduction: Ductal carcinoma in situ (DCIS) is a non-invasive non-obligate precursor of invasive breast cancer. With guideline concordant care (GCC), DCIS outcomes are at least as favourable as some other early stage cancer types such as prostate cancer, for which active surveillance (AS) is a standard of care option. However, AS has not yet been tested in relation to DCIS. The goal of the COMET (Comparison of Operative versus Monitoring and Endocrine Therapy) trial for low-risk DCIS is to gather evidence to help future patients consider the range of treatment choices for low-risk DCIS, from standard therapies to AS. The trial will determine whether there may be some women who do not substantially benefit from current GCC and who could thus be safely managed with AS. This protocol is version 5 (11 July 2018). Any future protocol amendments will be submitted to Quorum Centralised Institutional Review Board/local institutional review boards for approval via the sponsor of the study (Alliance Foundation Trials).

Methods And Analysis: COMET is a phase III, randomised controlled clinical trial for patients with low-risk DCIS. The primary outcome is ipsilateral invasive breast cancer rate in women undergoing GCC compared with AS. Secondary objectives will be to compare surgical, oncological and patient-reported outcomes. Patients randomised to the GCC group will undergo surgery as well as radiotherapy when appropriate; those in the AS group will be monitored closely with surgery only on identification of invasive breast cancer. Patients in both the GCC and AS groups will have the option of endocrine therapy. The total planned accrual goal is 1200 patients.

Ethics And Dissemination: The COMET trial will be subject to biannual formal review at the Alliance Foundation Data Safety Monitoring Board meetings. Interim analyses for futility/safety will be completed annually, with reporting following Consolidated Standards of Reporting Trials (CONSORT) guidelines for non-inferiority trials.

Trial Registration Number: NCT02926911; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2018-026797DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6429899PMC
March 2019

Cabozantinib Versus Mitoxantrone-prednisone in Symptomatic Metastatic Castration-resistant Prostate Cancer: A Randomized Phase 3 Trial with a Primary Pain Endpoint.

Eur Urol 2019 06 4;75(6):929-937. Epub 2018 Dec 4.

Department of Medicine, Genitourinary Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.

Background: Bone metastases in patients with metastatic castration-resistant prostate cancer (mCRPC) are associated with debilitating pain and functional compromise.

Objective: To compare pain palliation as the primary endpoint for cabozantinib versus mitoxantrone-prednisone in men with mCRPC and symptomatic bone metastases using patient-reported outcome measures.

Design, Setting, And Participants: A randomized, double-blind phase 3 trial (COMET-2; NCT01522443) in men with mCRPC and narcotic-dependent pain from bone metastases who had progressed after treatment with docetaxel and either abiraterone or enzalutamide.

Intervention: Cabozantinib 60mg once daily orally versus mitoxantrone 12mg/m every 3wk plus prednisone 5mg twice daily orally.

Outcome Measurements And Statistical Analysis: The primary endpoint was pain response at week 6 confirmed at week 12 (≥30% decrease from baseline in patient-reported average daily worst pain score via the Brief Pain Inventory without increased narcotic use). The planned sample size was 246 to achieve ≥90% power.

Results And Limitations: Enrollment was terminated early because cabozantinib did not demonstrate a survival benefit in the companion COMET-1 trial. At study closure, 119 participants were randomized (cabozantinib: N=61; mitoxantrone-prednisone: N=58). Complete pain and narcotic use data were available at baseline, week 6, and week 12 for 73/106 (69%) patients. There was no significant difference in the pain response with cabozantinib versus mitoxantrone-prednisone: the proportions of responders were 15% versus 17%, a -2% difference (95% confidence interval: -16% to 11%, p=0.8). Barriers to accrual included pretreatment requirements for a washout period of prior anticancer therapy and a narcotic optimization period to maximize analgesic dosing.

Conclusions: Cabozantinib treatment did not demonstrate better pain palliation than mitoxantrone-prednisone in heavily pretreated patients with mCRPC and symptomatic bone metastases. Future pain-palliation trials should incorporate briefer timelines from enrollment to treatment initiation.

Patient Summary: Cabozantinib was not better than mitoxantrone-prednisone for pain relief in patients with castration-resistant prostate cancer and debilitating pain from bone metastases.
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http://dx.doi.org/10.1016/j.eururo.2018.11.033DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6876845PMC
June 2019

Application of a Bayesian graded response model to characterize areas of disagreement between clinician and patient grading of symptomatic adverse events.

J Patient Rep Outcomes 2018 Dec 4;2(1):56. Epub 2018 Dec 4.

Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA.

Background: Traditional concordance metrics have shortcomings based on dataset characteristics (e.g., multiple attributes rated, missing data); therefore it is necessary to explore supplemental approaches to quantifying agreement between independent assessments. The purpose of this methodological paper is to apply an Item Response Theory (IRT) -based framework to an existing dataset that included unidimensional clinician and multiple attribute patient ratings of symptomatic adverse events (AEs), and explore the utility of this method in patient-reported outcome (PRO) and health-related quality of life (HRQOL) research.

Methods: Data were derived from a National Cancer Institute-sponsored study examining the validity of a measurement system (PRO-CTCAE) for patient self-reporting of AEs in cancer patients receiving treatment (N = 940). AEs included 13 multiple attribute patient-reported symptoms that had corresponding unidimensional clinician AE grades. A Bayesian IRT Model was fitted to calculate the latent grading thresholds between raters. The posterior mean values of the model-fitted item responses were calculated to represent model-based AE grades obtained from patients and clinicians.

Results: Model-based AE grades showed a general pattern of clinician underestimation relative to patient-graded AEs. However, the magnitude of clinician underestimation was associated with AE severity, such that clinicians' underestimation was more pronounced for moderate/very severe model-estimated AEs, and less so with mild AEs.

Conclusions: The Bayesian IRT approach reconciles multiple symptom attributes and elaborates on the patterns of clinician-patient non-concordance beyond that provided by traditional metrics. This IRT-based technique may be used as a supplemental tool to detect and characterize nuanced differences in patient-, clinician-, and proxy-based ratings of HRQOL and patient-centered outcomes.

Trial Registration: ClinicalTrials.gov NCT01031641 . Registered 1 December 2009.
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http://dx.doi.org/10.1186/s41687-018-0086-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6279753PMC
December 2018