Mian Wang’s research while affiliated with University of North Carolina at Chapel Hill and other places

Background Practice facilitators (PFs) provide tailored support to primary care practices to improve the quality of care delivery. Often used by PFs, the “Key Driver Implementation Scale” (KDIS) measures the degree to which a practice implements quality improvement activities from the Chronic Care Model, but the scale’s psychometric properties have not been investigated. We examined construct validity, reliability, floor and ceiling effects, and a longitudinal trend test of the KDIS items in the Southeastern Collaboration to Improve Blood Pressure Control trial. Methods The KDIS items assess a practice’s progress toward implementing: a clinical information system (using their own data to drive change); standardized care processes; optimized team care; patient self-management support; and leadership support. We assessed construct validity and estimated reliability with a multilevel confirmatory factor analysis (CFA). A trend test examined whether the KDIS items increased over time and estimated the expected number of months needed to move a practice to the highest response options. Results PFs completed monthly KDIS ratings over 12 months for 32 primary care practices, yielding a total of 384 observations. Data was fitted to a unidimensional CFA model; however, parameter fit was modest and could be improved. Reliability was 0.70. Practices started scoring at the highest levels beginning in month 5, indicating low variability. The KDIS items did show an upward trend over 12 months (all p < .001), indicating that practices were increasingly implementing key activities. The expected time to move a practice to the highest response category was 9.1 months for standardized care processes, 10.2 for clinical information system, 12.6 for self-management support, 13.1 for leadership, and 14.3 months for optimized team care. Conclusions The KDIS items showed acceptable reliability, but work is needed in larger sample sizes to determine if two or more groups of implementation activities are being measured rather than one.

The use of patient-reported outcomes measures is gaining popularity in clinical trials for comparing patient groups. Such comparisons typically focus on the differences in group means and are carried out using either a traditional sum-score-based approach or item response theory (IRT)-based approaches. Several simulation studies have evaluated different group mean comparison approaches in the past, but the performance of these approaches remained unknown under certain uninvestigated conditions (e.g. under the impact of differential item functioning (DIF)). By incorporating some of the uninvestigated simulation features, the current study examines Type I error, statistical power, and effect size estimation accuracy associated with group mean comparisons using simple sum scores, IRT model likelihood ratio tests, and IRT expected-a-posteriori scores. Manipulated features include sample size per group, number of items, number of response categories, strength of discrimination parameters, location of thresholds, impact of DIF, and presence of missing data. Results are summarized and visualized using decision trees.

Objectives Patients with lung cancer have high symptom burden and diminished quality of life. Electronic patient-reported outcome (PRO) platforms deliver repeated longitudinal surveys via web or telephone to patients and alert clinicians about concerning symptoms. This study aims to determine feasibility of electronic PRO monitoring in lung cancer patients receiving treatment in community settings. Methods Adults receiving treatment for advanced or metastatic lung cancer at 26 community sites were invited to participate in a prospective trial of weekly electronic PRO symptom monitoring for 12 months (NCT03249090). Surveys assessing patients’ satisfaction with the electronic PRO system were administered at 3 months. Descriptive statistics were generated for demographics, survey completion rates, symptom occurrence, and provider PRO alert management approaches. Pairwise relationships between symptom items were evaluated using intra-individual repeated-measures correlation coefficients. Results Lung cancer patients (n=118) participating in electronic PROs were older (mean 64.4 vs 61.9 years, p=0.03), had worse performance status (p=0.002), more comorbidities (p=0.02), and less technology experience than patients with other cancers. Of delivered weekly PRO surveys over 12 months, 91% were completed. Nearly all (97%) patients reported concerning (i.e., severe or worsening) symptoms during participation, with 33% of surveys including concerning symptoms. Pain was the most frequent and longest lasting symptom and was associated with reduced activity level. More than half of alerts to clinicians for concerning symptoms led to intervention. The majority (87%) would recommend using electronic PRO monitoring to other lung cancer patients. Conclusions Remote longitudinal weekly monitoring of patients with lung cancer using validated electronic PRO surveys was feasible in a multicenter, community-based pragmatic study. A high symptom burden specific to lung cancer was detected and clinician outreach in response to alerts was frequent, suggesting electronic PROs may be a beneficial strategy for identifying actionable symptoms and allow opportunities to optimize well-being in this population.

Purpose: Many research studies seek to assess health outcomes among patients across the adolescent adult age groups. This age group distinction often leads to independent scale creation and validation in self-report measures, such as the Patient-Reported Outcomes Measurement Information System® (PROMIS®) health-related quality of life (HRQOL) measures. Research studies would benefit from the ability to use a single measure across these age groups. Method: This study is a secondary data analysis of adolescents (age 14-17) and young adults (age 18-20) with special healthcare needs (n = 874). Participants completed short forms of both PROMIS pediatric and adult measures of physical functioning, pain, fatigue, depression , social health, anxiety, and anger. Differential item functioning (DIF) across age groups was examined using Wald tests for graded response model (GRM) item parameters.

7044 Background: There is growing interest to implement electronic patient-reported outcomes in oncology practices for symptom monitoring. It is not well known what nurse, physician, and patient impressions of benefits, acceptability, and challenges are in routine care use. Methods: PRO-TECT is an ongoing U.S. national trial including 26 community oncology practices across 15 states that implemented PRO symptom monitoring [NCT03249090]. Patients complete weekly PROs between visits, nurses receive alerts for severe/worsening symptoms, and oncologists review PROs at office visits. Interviews were conducted with 147 stakeholders including nurses (N = 46), oncologists (N = 27), data managers (N = 15), and patients (N = 59). Each stakeholder group had different interview guides with overlapping topics to explore experiences with the PRO system. Interviews lasted 15-60 minutes, were digitally recorded, transcribed, and entered into a qualitative analysis software program. A codebook was developed from the research questions, interview guides, and discussions with the project team. Standardized coding methods were applied, with transcripts double coded for thematic analysis. Feedback surveys were also completed by nurses (N = 57), oncologists (N = 38), and patients (N = 435). Results: Key benefits perceived across stakeholder groups included increased patient self-awareness of symptoms; improved direct communication of patients with care teams; more open and honest conveying of symptom experiences; ability to track symptoms over time; and increased involvement of patients in their own care. Most stakeholders felt PRO symptom monitoring had a positive impact on quality of care delivery, and believed benefits of PROs outweighed necessary staff efforts. Challenges included additional work by nurses to review and respond to alerts, staff turnover requiring retraining, and limited time of oncologists. In the survey, 39/56 (70%) nurses felt the PRO system improved quality of care; 27/33 (82%) oncologists noted PROs were useful for team discussions and care delivery; and 320/434 (74%) patients agreed that weekly PRO reporting improved discussions with their care team. Conclusions: Clinicians and patients perceived weekly PRO symptom monitoring between visits to be valuable despite added staff effort. Results of additional analyses are forthcoming. Clinical trial information: NCT03249090 .

Background Clinicians are the standard source for adverse event (AE) reporting in oncology trials, despite the subjective nature of symptomatic AEs. The authors designed a pediatric patient‐reported outcome (PRO) instrument for symptomatic AEs to support the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) (the Pediatric PRO‐CTCAE). The current study developed a standardized algorithm that maps all possible Pediatric PRO‐CTCAE response patterns to recommended CTCAE grades to improve the accuracy of AE reporting in pediatric oncology trials. Methods Two rounds of surveys were administered to experienced cancer clinicians across 9 pediatric hospitals. In round 1, pediatric oncologists assigned CTCAE grades to all 101 possible Pediatric PRO‐CTCAE response patterns. The authors evaluated clinician agreement of CTCAE grades across response patterns and categorized each response pattern as having high or low agreement. In round 2, a survey was sent to a larger clinician group to examine clinician agreement among a select set of Pediatric PRO‐CTCAE response patterns, and the authors examined how clinical context influenced grade assignment. Results A total of 10 pediatric oncologists participated in round 1. Of the 101 possible patterns, 89 (88%) had high agreement. The Light weighted kappa was averaged across the 10 oncologists (Light kappa = 0.73; 95% CI, 0.66‐0.81). A total of 139 clinicians participated in round 2. High clinician agreement remained for the majority of generic response patterns and the clinical context did not typically change grades but rather improved agreement. Conclusions The current study provides a framework for integrating child self‐reported symptom data directly into mandated AE reporting in oncology trials. Translating Pediatric PRO‐CTCAE responses into clinically meaningful metrics will guide future cancer care and toxicity grading.

Background: There are multiple treatment options for men with localized prostate cancer that provide similar curative efficacy but differ in their impact on sexual functioning. Aim: To evaluate the psychometric properties of the Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction (SexFS) measures, including items from versions 1 and 2 of the short forms. Methods: A population-based cohort of men across North Carolina completed surveys via phone interviews at baseline (prior to treatment) and at 3, 12, and 24 months after cancer treatment initiation. Surveys included the PROMIS SexFS domains of interest in sexual activity, erectile function, orgasm, and satisfaction and the Prostate Cancer Symptom Indices. Analyses included descriptive statistics, assessment of structural validity using confirmatory factor analysis and item response theory, tests for differential item functioning, assessment of convergent validity using correlations, and evaluation of responsiveness of the PROMIS SexFS measures over time. We hypothesized that men undergoing surgery (prostatectomy) would report the poorest sexual function at the 3-month survey. Results: Sample size varied by assessment point and ranged from 332‒939 men, consisting of 30% non-white men, and 30% of the sample had a high school degree or less. The items within the PROMIS orgasm domain did not form a unidimensional scale. PROMIS measures of interest in sexual activity, erectile function, and satisfaction were unidimensional and highly correlated with related Prostate Cancer Symptom Indices measures (eg, erectile function, r = 0.84‒0.95). Erectile function in the surgery group declined more at 3 months compared to the no-surgery group (2 points); this difference narrowed at 12 and 24 months after surgery, as the surgery group recovered over time. Results were similar for PROMIS Interest in Sexual Activity and PROMIS Satisfaction scales. Clinical implications: The PROMIS SexFS measures may be used to identify effective interventions to treat sexual dysfunction and monitor sexual functioning in men with prostate cancer over time. Strength & limitations: This study was limited to men living in North Carolina who could self-report their health-related quality of life in English. However, this study was able to include more men from vulnerable populations by allowing them to self-report over the phone. Conclusion: This study provided strong support for use of the PROMIS SexFS (version 2) measures in men with localized prostate cancer to assess sexual interest, erectile function, and satisfaction over time. Reeve BB, Wang M, Weinfurt K, et al. Psychometric Evaluation of PROMIS Sexual Function and Satisfaction Measures in a Longitudinal Population-Based Cohort of Men With Localized Prostate Cancer. J Sex Med 2018;15:1792-1810.

Purpose: To evaluate measurement invariance (phone interview vs computer self-administered survey) of 15 PROMIS measures responded by a population-based cohort of localized prostate cancer survivors. Methods: Participants were part of the North Carolina Prostate Cancer Comparative Effectiveness and Survivorship Study. Out of the 952 men who took the phone interview at 24 months post-treatment, 401 of them also completed the same survey online using a home computer. Unidimensionality of the PROMIS measures was examined using single-factor confirmatory factor analysis (CFA) models. Measurement invariance testing was conducted using longitudinal CFA via a model comparison approach. For strongly or partially strongly invariant measures, changes in the latent factors and factor autocorrelations were also estimated and tested. Results: Six measures (sleep disturbance, sleep-related impairment, diarrhea, illness impact-negative, illness impact-positive, and global satisfaction with sex life) had locally dependent items, and therefore model modifications had to be made on these domains prior to measurement invariance testing. Overall, seven measures achieved strong invariance (all items had equal loadings and thresholds), and four measures achieved partial strong invariance (each measure had one item with unequal loadings and thresholds). Three measures (pain interference, interest in sexual activity, and global satisfaction with sex life) failed to establish configural invariance due to between-mode differences in factor patterns. Conclusions: This study supports the use of phone-based live interviewers in lieu of PC-based assessment (when needed) for many of the PROMIS measures.