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Background We aimed to obtain general population-based Korean reference values for the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) item bank v2.0 and to compare them with US and Netherlands reference values. Methods In April 2021, we surveyed Korean representative participants ( N  = 2,124) using the PROMIS PF item bank. We compared the mean T-scores of the Netherlands ( N  = 1,310) and US populations ( N  = 1,646) using ANOVA by age group, sex, presence of comorbidities, and general health. We also performed Differential item functioning (DIF) analyses between the US and Korea populations. Results In Korean, the PF T-score was 55.3 (SD = 9.1), ranging from 28.7 to 77.6. This score was higher compared to the mean score of 50.0 in the US and 49.8 in the Netherlands general populations. Differences in PF were generally observed in all age and sex groups. In the PF item bank, 57 of 131 items were flagged for uniform or nonuniform DIF. Among the general population in Korea, older adults, women, those with lower levels of education, and those with comorbidities had lower levels of PF compared to their counterparts in the general Korean population. Conclusions Considering the cultural differences between Western and Asian countries, we recommend establishing country-specific reference values on a global scale.

Objectives This study aimed to compared Patient‐Reported Outcomes Measurement Information System (PROMIS) anxiety, depression, and anger item bank among Korean, US and Dutch general population. Methods Between December 2021 and January 2022, we surveyed representative Korean participants (N = 2699). Then we compared the mean T‐scores of PROMIS anxiety, depression, and anger full items bank among Korean, US (N = 1696) and the Dutch (N = 1002) populations. Differential item‐functioning (DIF) analyses were also performed. We also compared each score by age group, sex, presence of comorbidities, and general health status. Results In Korean, the mean T‐scores for anxiety, depression, and anger were 45.3 (standard deviation [SD] = 11.6), 48.4 (SD = 11.2), and 44.9 (SD = 12.6), respectively. Among the general population in Korea, patients aged 35–44 years and those with comorbidities had higher anxiety, depression, and anger scores. In the DIF analyses between the US and Korean populations, 28%, 32%, and 45% were flagged for uniform or non‐uniform DIF in anxiety, depression and anger, respectively. Conclusions Considering the cultural differences, we recommend using a harmonized approach that includes country‐specific reference values while retaining a standardized core set of items to enable cross‐country comparability.

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

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

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.

Background Researchers and clinicians studying symptoms experienced by people with cancer must choose from various scales. It would be useful to know how the scores on one measure translate to another. Methods Using item response theory (IRT) with the single-group design, in which the same sample answers all measures, we produced crosswalk tables linking five 0–10 numeric rating scale (NRS) and 15 items from Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE, scored on a 1–5 scale) to the T-Score metric of six different scales from the NIH Patient reported Outcomes Measurement Information System (PROMIS®). The constructs, for which we conducted linking, include emotional distress-anxiety, emotional distress-depression, fatigue, sleep disturbance, pain intensity, and pain interference. We tested the IRT linking assumption of construct similarity between measures by comparing item content and testing unidimensionality of item sets comprising each construct. We also investigated the correlation of the measures to be linked and, by inspecting standardized mean differences, whether the linkage is invariant across age and gender subgroups. For measures that satisfied the assumptions, we conducted linking. Results In general, an NRS score of 0 corresponded to about 38.2 on the PROMIS T-Score scale (mean = 50; SD = 10); whereas an NRS score of 10 corresponded to a PROMIS T-Score of approximately 72.7. Similarly, the lowest/best score of 1 on PRO-CTCAE corresponded to 39.8 on T-score scale and the highest/worst score of 5 corresponded to 72.0. Conclusion We produced robust linking between single item symptom measures and PROMIS short forms.

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.

To examine the factor structure and differential item functioning (DIF) of the Patient Experience with Treatment and Self-management (PETS version 2.0), a measure of treatment burden. Version 2.0 of the PETS has 60 items, extending the previously-validated 48-item version 1.0 by three domains (nine items) and three additional items in an existing domain. We conducted confirmatory factor analyses (CFA) on survey responses of 439 community-dwelling adults living with multiple chronic conditions who completed PETS version 2.0, using R packages, \"lavaan\" and \"semTools.\" We tested fit of second-order factors to explore simplifying the reporting of PETS scores. We examined DIF for the two second-order factors with \"lordif\" R package, testing groups by gender, education, and health literacy, using the McFadden pseudo change criterion of ≥0.02 to flag items with DIF. Cronbach's alpha and the intraclass correlation coefficient (ICC) were used to determine the reliability of PETS domains. The first-order CFA model featuring 12 multi-item domains had an excellent fit (Comparative Fit Index [CFI]=0.989), as did the second-order CFA model (CFI=0.987), specifying two superordinate factors of treatment burden (workload and impact). Items in the workload and impact second-order factors did not show any DIF across gender, education, and health literacy groups as shown by McFadden pseudo changes <0.02. Cronbach's alphas for all multi-item domain scales were ≥0.80, and ICCs of ten scales were ≥0.70, meeting the threshold for adequate test-retest reliability. Findings support the construct validity and reliability of PETS version 2.0. The fit of a factor model featuring superordinate (ie, second-order) factors of workload and impact supports index scoring that will simplify reporting of PETS scores. DIF analyses indicate that items from these indices can be interpreted in the same way, regardless of gender, education, or health literacy.

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.