Body Size Perceptions Associated with Body Mass Index and Weight Loss Intentions Among Two Immigrant Populations.

BACKGROUND: The rates of obesity among immigrant populations within the USA rise with increasing duration of residency. The aims of this study were to examine weight self-perception and body image discrepancy within a large community sample of Hispanic and Somali predominantly immigrant adults. METHODS: Utilizing a community-based participatory research (CBPR) approach to collect survey data from a sample of adults who self-identified as Hispanic, Latino, or Somali in Southeast Minnesota. Correlations among actual body mass index (BMI), perceived weight category, and perceived body size were assessed with Spearman rank correlation coefficients. Associations of weight loss intentions with actual BMI, perceived weight category, perceived body size, and body image discrepancy were assessed using Kruskal-Wallis nonparametric tests. RESULTS: A total of 1256 adults completed the survey and biometric measurements (610 Hispanic, 646 Somali); 81% (457) and 50% (328) had a BMI in the overweight or obese category in the Hispanic and Somali cohorts, respectively. Among participants with a BMI of > 25, more participants reported a perceived body size that was overweight or obese than a perceived weight category that was in the overweight or obese category (79% vs. 48%, p = < 0.0001). Body image discrepancy, but not actual BMI, was associated with weight loss intentions for both groups. Perceived body size and perceived weight category were associated with weight loss intentions for Hispanic participants only. CONCLUSIONS: Perceived body size is a more accurate self-report proxy of BMI-defined weight status compared with the perceived weight category among Hispanic and Somali immigrant groups. Body image discrepancy may be more predictive of weight loss intentions than actual BMI.

Negative Mood is Associated with Sociobehavioral Factors Contributing to Cardiovascular Risk in an Immigrant Population.

Background: Immigrants to the United States, on average, accumulate cardiovascular risk after resettlement, including obesity. There is a need to co-create interventions to address these disparities, and mood may be an important mediating factor. Methods: The Healthy Immigrant Community (HIC) study, set in southeast Minnesota, enrolled 475 adult participants in a weight loss intervention to reduce cardiovascular risk. Baseline questionnaires assessed mood, nutrition, physical activity, self-efficacy for healthy eating and physical activity, social support, and cohesion. A single-item mood rating of poor or fair was considered "negative", while ratings of good, very good, or excellent were considered "positive". Results: A total of 449 HIC participants (268 Hispanic/Latino and 181 Somali) with complete baseline measures and were included in this analysis. Participants endorsing negative mood compared to those endorsing positive mood had lower scores for healthy eating (p = 0.02) and physical activity levels (p = 0.03), lower confidence in eating a healthy diet (p = 0.001), and felt less of a sense of belonging to their community (p = 0.01). Those endorsing negative mood also reported receiving less social support from their family and friends to eat healthy (p = < 0.001) and be physically active (p = 0.01), and less often accessed community resources for healthy eating (p = 0.001) and physical activity (p = < 0.01) compared to participants reporting positive mood. Conclusions: Negative mood was associated with less healthy nutrition, lower confidence in eating healthy, sedentary lifestyle, and perceived lack of belonging to the community. Integrating mood management and self-efficacy strategies may enhance the effectiveness of lifestyle interventions among immigrants who report negative mood. ClinicalTrialsgov registration: NCT05136339; April 23, 2022.

Longitudinal cognitive function and brain metabolites in women receiving chemotherapy for stage 1 to 3 breast cancer: Observational study.

Few proton magnetic resonance spectroscopy studies have explored chemotherapy-related biochemical changes in brain regions. This observational study aimed to longitudinally assess short-term cognitive changes and brain metabolite concentrations in women undergoing chemotherapy for breast cancer. We analyzed 11 women with newly diagnosed stage 1 to 3 breast cancer. Patients were evaluated via objective cognitive testing, and patient self-report tests. Patients were examined using single voxel proton magnetic resonance spectroscopy in the medial frontal cortex, posterior cingulate gyrus, and left thalamus at baseline and after the completion of chemotherapy on a 1.5 Tesla scanner. At the posttreatment evaluation as compared to baseline, 7 of the 10 (70%) patients reported worsening memory on the MD Anderson symptom inventory (annualized change = 1.82 ± 2.88, P = .08), while the delayed recall raw score of the Rey Osterrieth complex figure test did not change from pre- to post-chemotherapy (mean annualized change = 5.00 ± 14.38, P = .30). The annualized change in the creatine concentration in the posterior cingulate gyrus was statistically significant. The annualized change in the MD Anderson symptom inventory was negatively correlated with the annualized change in the medial frontal N-acetylaspartate (Spearman correlation coefficient [rho] = -0.78, P = .01) and positively correlated with the annualized change in the posterior cingulate gyrus creatine (rho = 0.66, P = .04). Annualized changes in the Rey Osterrieth complex figure test were positively correlated with annualized changes in choline (rho = 0.83, P = .01) in the medial frontal cortex, choline (rho = 0.76, P = .04) in the left thalamus, and creatine (rho = 0.73, P = .02) in the medial frontal cortex. Our data suggest that chemotherapy may lead to the worsening of self-reported memory function, which is associated with alterations in brain metabolites.

Baseline Quality of Life is a Strong and Independent Prognostic Factor for Overall Survival in Metastatic Colorectal Cancer.

BACKGROUND: Previous studies have established that higher baseline quality of life (QOL) scores are associated with improved survival in patients with metastatic colorectal cancer (mCRC). We examined the relationship between overall survival (OS) and baseline QOL. PATIENTS AND METHODS: A total of 1 247 patients with mCRC participating in N9741 (comparing bolus 5-FU/LV, irinotecan [IFL] vs infusional 5-FU/leucovorin [LV]/oxaliplatin [FOLFOX] vs. irinotecan/oxaliplatin [IROX]) provided data at baseline on overall QOL using a single-item linear analogue self-assessment (LASA) 0-100 point scale. The association of OS according to clinically deficient (defined as CD-QOL, score 0-50) vs not clinically deficient (nCD-QOL, score 51-100) baseline QOL scores was tested. A multivariable analysis using Cox proportional hazards modeling was performed to adjust for the effects of multiple baseline factors. An exploratory analysis was performed evaluating OS according to baseline QOL status among patients who did or did not receive second-line therapy. RESULTS: Baseline QOL was a strong predictor of OS for the whole cohort (CD-QOL vs nCD-QOL: 11.2 months vs 18.4 months, P < .0001), and in each arm IFL 12.4 vs 15.1 months, FOLFOX 11.1 months vs 20.6 months, and IROX 8.9 months vs 18.1 months. Baseline QOL was associated with baseline performance status (PS) (P < .0001). After adjusting for PS and treatment arm, baseline QOL was still associated with OS (P = .017). CONCLUSIONS: Baseline QOL is an independent prognostic factor for OS in patients with mCRC. The demonstration that patient-assessed QOL and PS are independent prognostic indicators suggests that these assessments provide important complementary prognostic information.

An evaluation of the effect of lithium on taxane-induced neuropathy.

PURPOSE: No medications are known to protect against chemotherapy-induced peripheral neuropathy (CIPN). Pre-clinical models suggest that lithium may lessen taxane-induced neuropathy. Our aim was to use clinical data to assess whether concurrent lithium usage decreased the frequency or severity of CIPN in patients receiving taxane chemotherapy. METHODS: A retrospective analysis was performed using the electronic health record at Mayo Clinic to identify all patients prescribed concurrent lithium and paclitaxel. Four controls were matched to each case based on clinical variables. Neuropathy severity was graded from available patient and clinician reports. Rates of any neuropathy, dose reduction for CIPN, and treatment discontinuation for CIPN were compared. Conditional regression analysis was performed with propensity score matching. RESULTS: Six patients, receiving concurrent lithium and paclitaxel, were included in the analysis, and compared to 24 control cases. A similar number of paclitaxel cycles were administered to both groups. Any neuropathy was experienced by 33% (2/6) of patients receiving lithium and 38% (9/24) patients who did not receive lithium (p = 1.000). There was no difference in neuropathy severity (p = 0.8565), rate of chemotherapy dose reduction (17% vs. 17%, p = 1.000), or treatment discontinuation (17% vs 4%, p = 0.3655) for CIPN. In the propensity score analysis, the odds ratio for developing any neuropathy was 0.63 (95% confidence interval, 0.06 to 6.96, p = 0.7079). CONCLUSIONS: Lithium does not appear to significantly lessen the risk of neuropathy for patients receiving paclitaxel. IMPLICATIONS FOR CANCER SURVIVORS: Targeted approaches for preventing CIPN are desperately needed. Despite sound scientific rationale, the current study did not identify neuroprotective properties of lithium.

Stories for change protocol: A randomized controlled trial of a digital storytelling intervention for Hispanic/Latino individuals with type 2 diabetes.

BACKGROUND: Hispanic/Latino adults are disproportionately impacted by type 2 diabetes mellitus (T2D). The Stories for Change (S4C) Diabetes digital storytelling intervention promotes T2D self-management among Hispanic/Latino people. We describe the S4C protocol and participant baseline characteristics. METHODS: Study eligibility criteria: Hispanic or Latino, age 18-70 years, ≥1 office visit within a year at a participating clinic, T2D diagnosis for ≥6 months, HbA1c ≥ 8%, and intention to continue care at the recruitment clinic. We used a two-group, parallel randomized controlled trial design and an intervention derived through a community-based participatory research approach. All participants received usual diabetes care and two cards describing how to engage healthcare teams and access diabetes-related resources. At baseline, the intervention group additionally viewed the 12-min, intervention video (four stories about diabetes self-management). To encourage subsequent video viewing, participants received five monthly text messages. The messages prompted them to self-rate their motivation and self-efficacy for T2D management. The control group received no additional intervention. Bilingual (English/Spanish) staff collected data at baseline, six weeks, three months, and six months including biometric measurements and a survey on diabetes self-management outcomes, theory-based measures, and the number of video views. We reviewed the number of diabetes-related appointments attended using electronic medical record data. RESULTS: Participants (n = 451; 70% women, mean age = 53 years) had an average HbA1C ≥9%. Intervention participants reported identifying with the storytellers and engaging with the stories. CONCLUSION: We present a digital storytelling intervention protocol that provides a template for future health promotion interventions prioritizing health disparity populations. CLINICALTRIAL: gov#NCT03766438.

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

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

Hot flash clinical trial baseline measurements: how long is needed?

OBJECTIVES: Classically, hot flash studies included a baseline period of 1 week or longer. The objective of this study was to compare the accuracy of a 1-day baseline diary to a traditional 1-week diary. METHODS: Raw data from 5 pilot studies and 15 phase III randomised controlled trials (RCTs), all of which used a 1-week baseline period, were obtained. Descriptive statistics were used to describe day-by-day variations in hot flash frequencies and scores, during the baseline week. Additional analyses evaluated whether the conclusions from any of the individual pilot studies would have been changed if only a 1-day baseline period had been used. For the RCTs, p values were recalculated using mixed models, adjusting for the baseline value by including it as a covariate. RESULTS: A total of 2573 participants were included. On average, participants had 8.5 hot flashes per day on day 1. Mean hot flash frequencies and scores on subsequent days (days 2-7) were within 6% of day 1 values. When comparing a 1-day to a 1-week baseline period, there was an absolute difference of only 0.29 hot flashes per day (SD 2.25). Reanalysis for each pilot study revealed that no individual study conclusions would have been altered by a shorter baseline. For the RCTs, a shorter baseline period changed the results of only 1 of 24 comparisons from statistically significant to not significant, or vice versa. CONCLUSIONS: A 1-day hot flash diary appears to accurately reflect the true frequency and severity of baseline symptoms in appropriately sized cohorts.

Experiences of Hispanic Safety Net Clinic Patients With Diabetes During the COVID-19 Pandemic.

PURPOSE: The purpose of this study was to characterize the material, health (general and diabetes-specific), and social impacts of the COVID-19 pandemic on Hispanic adults with type 2 diabetes who did not experience COVID-19 infection. METHODS: This cross-sectional and longitudinal study used surveys within a clinical trial of 79 Hispanic adult clinic patients with type 2 diabetes. Cross-sectional measures included the Coronavirus Anxiety Scale, items from the Coronavirus Impact Scale, and the Pandemic Impacts Inventory. Longitudinal measures included the Summary of Diabetes Self-Care, health care utilization, and measures of diabetes self-efficacy, social support, and quality of life. RESULTS: Participants were majority low-income, Spanish-speaking females with poor diabetes control. Coronavirus anxiety was low despite majority of participants having an affected family member and frequent access barriers. More than half of participants reported moderate/severe pandemic impact on their income. Diabetes self-care behaviors did not change between prepandemic and pandemic measures. Diabetes self-efficacy and quality of life improved despite fewer diabetes-related health care visits. CONCLUSIONS: Despite high levels of access barriers, financial strain, and COVID-19 infection of family members, Hispanic adults with type 2 diabetes continued to prioritize their diabetes self-management and demonstrated substantial resilience by improving their self-efficacy and quality of life.

Effects of patient-reported outcome assessment order.

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

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

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

Differences in Sedentary Time, Light Physical Activity, and Steps Associated with Better COPD Quality of Life.

INTRODUCTION: There is a knowledge gap about how much physical activity is recommended to patients with chronic obstructive pulmonary disease (COPD). We asked, what is the average difference in sedentary time and physical activity associated with clinically meaningful differences in symptoms in a large, well-characterized cohort of patients with advanced COPD? STUDY DESIGN AND METHODS: We conducted a cross-sectional analysis of daily activity data in 292 patients with stable COPD. Activity measure coefficients from multivariable linear models were used to predict the average difference in activity between patients with twice the minimal clinically important difference in reported symptoms. RESULTS: Symptoms were assessed with the Chronic Respiratory Disease Questionnaire subdomains - dyspnea, fatigue, mastery, and emotions. Daily steps, minutes in light physical activity, and sedentary time were measured by triaxial accelerometers. Average sedentary time, light physical activity, and steps were 767.6 minutes, 177.7 minutes, and 2960 steps, respectively. Individuals with 1-point better dyspnea scores averaged 24.5 (8.4-40.5) minutes less sedentary time per day. Individuals with 1-point better dyspnea and fatigue scores averaged 21.5 (10.9-32.3) minutes or 12.5 (2.0-23.2) minutes more light physical activity per day, respectively. Individuals with 1-point better dyspnea, fatigue, mastery, and emotions scores averaged 762 (546-984), 579 (351-814), 418 (207-636), and 392 (157-634) more steps per day, respectively. CONCLUSIONS: We provide guidance to clinicians counseling patients with severe COPD in activity-related goal setting on sedentary time, light physical activity, and steps associated with better symptoms.

Decision aids for localized prostate cancer in diverse minority men: Primary outcome results from a multicenter cancer care delivery trial (Alliance A191402CD).

BACKGROUND: Decision aids (DAs) can improve knowledge for prostate cancer treatment. However, the relative effects of DAs delivered within the clinical encounter and in more diverse patient populations are unknown. A multicenter cluster randomized controlled trial with a 2×2 factorial design was performed to test the effectiveness of within-visit and previsit DAs for localized prostate cancer, and minority men were oversampled. METHODS: The interventions were delivered in urology practices affiliated with the NCI Community Oncology Research Program Alliance Research Base. The primary outcome was prostate cancer knowledge (percent correct on a 12-item measure) assessed immediately after a urology consultation. RESULTS: Four sites administered the previsit DA (39 patients), 4 sites administered the within-visit DA (44 patients), 3 sites administered both previsit and within-visit DAs (25 patients), and 4 sites provided usual care (50 patients). The median percent correct in prostate cancer knowledge, based on the postvisit knowledge assessment after the intervention delivery, was as follows: 75% for the pre+within-visit DA study arm, 67% for the previsit DA only arm, 58% for the within-visit DA only arm, and 58% for the usual-care arm. Neither the previsit DA nor the within-visit DA had a significant impact on patient knowledge of prostate cancer treatments at the prespecified 2.5% significance level (P = .132 and P = .977, respectively). CONCLUSIONS: DAs for localized prostate cancer treatment provided at 2 different points in the care continuum in a trial that oversampled minority men did not confer measurable gains in prostate cancer knowledge.

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

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

Do Missing Values Influence Outcomes in a Cross-sectional Mail Survey?

OBJECTIVE: To determine the effects of missing and inconsistent data on a weight management mail survey results. PATIENTS AND METHODS: Weight management surveys were sent to 5000 overweight and obese individuals in the Learning Health System Network. Survey information was collected between October 27, 2017, and March 1, 2018. Some participants reported body mass index (BMI) values inconsistent with the intended overweight and obese sampling cohort. Analyses were performed after excluding these surveys and also performed again after setting these low BMI values to missing. Models were run after imputing missing values using expectation-maximization, Markov chain Monte Carlo, random forest imputation, multivariate imputation by chained equations, and multiple imputation and replacing missing BMI values with the minimum, maximum, mean, or median of the known BMI values. RESULTS: Of 2799 surveys, 222 (8%) had missing BMI values and 155 (6%) reported invalid BMI values. Overall, 725 of these 2799 surveys (26%) were missing at least 1 variable that was essential to the main analyses. Different imputation methods consistently found that BMI was related to age, sex, race, marital status, and education. Patients with a BMI of 35.0 kg/m2 or greater were more likely to feel judged because of their weight, and patients with a BMI of 40.0 kg/m2 or greater were more likely to feel they were not always treated with respect and treated as an equal. CONCLUSION: Analyses using different imputation methods were consistent with the original published results. Missing data likely did not affect the study results.

Expanding Beyond Maximum Grade: Chemotherapy Toxicity over Time by Age and Performance Status in Advanced Non-Small Cell Lung Cancer in CALGB 9730 (Alliance A151729).

BACKGROUND: Prior comparisons of chemotherapy adverse events (AEs) by age and performance status (PS) are limited by the traditional maximum grade approach, which ignores low-grade AEs and longitudinal changes. MATERIALS AND METHODS: To compare fatigue and neuropathy longitudinally by age (<65, ≥65 years) and PS (0-1, 2), we analyzed data from a large phase III trial of carboplatin and paclitaxel versus paclitaxel for advanced non-small cell lung cancer (CALGB 9730, n = 529). We performed multivariable (a) linear mixed models to estimate mean AE grade over time, (b) linear regression to estimate area under the curve (AUC), and (c) proportional hazards models to estimate the hazard ratio of developing grade ≥2 AE, as well as traditional maximum grade analyses. RESULTS: Older patients had on average a 0.17-point (95% confidence interval [CI], 0.00-0.34; p = .049) higher mean fatigue grade longitudinally compared with younger patients. PS 2 was associated with earlier development of grade ≥2 fatigue (hazard ratio [HR], 1.56; 95% CI, 1.07-2.27; p = .02). For neuropathy, older age was associated with earlier development of grade ≥2 neuropathy (HR, 1.41; 95% CI, 1.00-1.97; p = .049). Patients with PS 2 had a 1.30 point lower neuropathy AUC (95% CI, -2.36 to -0.25; p = .02) compared with PS 0-1. In contrast, maximum grade analyses only detected a higher percentage of older adults with grade ≥3 fatigue and neuropathy at some point during treatment. CONCLUSION: Our comparison of complementary but distinct aspects of chemotherapy toxicity identified important longitudinal differences in fatigue and neuropathy by age and PS that are missed by the traditional maximum grade approach. Clinical trial identification number: NCT00003117 (CALGB 9730) IMPLICATIONS FOR PRACTICE: The traditional maximum grade approach ignores persistent low-grade adverse events (AEs) and changes over time. This toxicity over time analysis of fatigue and neuropathy during chemotherapy for advanced non-small cell lung cancer demonstrates how to use longitudinal methods to comprehensively characterize AEs over time by age and performance status (PS). We identified important longitudinal differences in fatigue and neuropathy that are missed by the maximum grade approach. This new information about how older adults and patients with PS 2 experience these toxicities longitudinally may be used clinically to improve discussions about treatment options and what to expect to inform shared decision making and symptom management.

Establishing a common metric for patient-reported outcomes in cancer patients: linking patient reported outcomes measurement information system (PROMIS), numerical rating scale, and patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).

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.

Longitudinal Toxicity over Time (ToxT) analysis to evaluate tolerability: a case study of lenalidomide in the CALGB 50401 (Alliance) trial.

Evaluation of tolerability is increasingly relevant for patients with haematological malignancies treated with chronically administered therapies. Adverse events from these agents might affect the ability of patients to tolerate treatment over time. Conventional toxicity tables that include the incidence of high-grade adverse events, defined by the Common Terminology Criteria for Adverse Events, do not provide information on the time profile of these adverse events or reflect the continuous, lower grade symptomatic toxicities that are particularly relevant to treatment tolerability for patients living with indolent disease. Modern approaches to the evaluation and reporting of toxicity that capture the tolerability of treatment to the patient are imperative. In this Viewpoint, we present a focused, pilot, and longitudinal Toxicity over Time analysis of adverse events from lenalidomide and lenalidomide with rituximab in patients with follicular lymphoma treated in the CALGB 50401 (Alliance; NCT00238238) trial to define the trajectory of adverse events and quantify the burden of continuous, low-grade events. Toxicity over Time analyses provided clinically relevant descriptions of neutropenia and fatigue trajectories caused by lenalidomide that were not identified by standard analysis of the maximum grade events defined by the Common Terminology Criteria for Adverse Events. Systematic, rigorous incorporation of patient-reported outcomes in clinical trials will be crucial to our understanding of the tolerability of chronically administered therapies in patients with haematological malignancies.