Impact of including drug spending in oncology alternative payment models.

OBJECTIVES: To develop a method for determining the effect of including drug costs in alternative payment models (APMs). STUDY DESIGN: Retrospective claims analysis. METHODS: Using the Oncology Care Model as an example, we developed an oncology episode payment model for a commercial payer using historical claims data. We defined 6-month episodes of chemotherapy. Using claims data, we characterized episodes and developed a risk adjustment model. We used bootstrapping to estimate the variation in episode cost with drugs included and without. RESULTS: Episode costs were approximately $100,000. Although absolute cost variation was higher when we included drugs, the percent of total cost represented by variation was lower. Under reasonable assumptions about potential savings from drug and nondrug spending, our results suggest that including drugs in APMs can improve the risk-benefit trade-off faced by provider groups. We introduce a risk-mitigated sharing rate that may enable inclusion of drugs in APMs without substantially increasing downside risk. CONCLUSIONS: We have developed a method to assess whether the inclusion of drug spending in APMs is a good decision for provider groups. Including drug costs in episode payments for oncology patients may be preferable for many provider groups.

The Effect of a System-Level Tiered Huddle System on Reporting Patient Safety Events: An Interrupted Time Series Analysis.

BACKGROUND: The objective of this research was to evaluate the effect of implementing a system-level tiered huddle system (THS) on the reporting of patient safety events into the official event reporting system. METHODS: A quasi-experimental study using interrupted time series was conducted to assess the impact and changes to trends in the reporting of patient safety events pre- (February-July 2020; six months) and post- (September 2020-February 2021; six months) THS implementation within one health care system (238 clinics and 4 hospitals). The severity of harm was analyzed in July 2021 using a modified Agency for Healthcare Research and Quality (AHRQ) harm score classification. The primary outcome measure was the number of patient safety events reported per month. Secondary outcomes included the number of patient safety events reported per month by each AHRQ harm score classification. RESULTS: The system-level THS implementation led to a significant and immediate increase in the total number of patient safety events reported per month (777.73, 95% confidence interval [CI] 310.78-1,244.68, p = 0.004). Similar significant increases were seen for reported numbers of unsafe conditions, near misses, no-harm events that reached patients, and temporary harm (p < 0.05 for each). Reporting of events with permanent harm and deaths also increased but was not statistically significant, likely due to the small number of reported events involving actual harm. CONCLUSION: These findings suggest that system-level THS implementation may increase reporting of patient safety events in the official event reporting system.

The STUN (STop UNhealthy) Alcohol Use Now trial: study protocol for an adaptive randomized trial on dissemination and implementation of screening and management of unhealthy alcohol use in primary care.

BACKGROUND: Unhealthy alcohol use is a leading cause of preventable deaths in the USA and is associated with many societal and health problems. Less than a third of people who visit primary care providers in the USA are asked about or ever discuss alcohol use with a health professional. METHODS/DESIGN: This study is an adaptive, randomized, controlled trial to evaluate the effect of primary care practice facilitation and telehealth services on evidence-based screening, counseling, and pharmacotherapy for unhealthy alcohol use in small-to-medium-sized primary care practices. Study participants will include primary care practices in North Carolina with 10 or fewer providers. All enrolled practices will receive a practice facilitation intervention that includes quality improvement (QI) coaching, electronic health record (EHR) support, training, and expert consultation. After 6 months, practices in the lower 50th percentile (based on performance) will be randomized to continued practice facilitation or provision of telehealth services plus ongoing facilitation for the next 6 months. Practices in the upper 50th percentile after the initial 6 months of intervention will continue to receive practice facilitation alone. The main outcome measures include the number (and %) of patients in the target population who are screened for unhealthy alcohol use, screen positive, and receive brief counseling. Additional measures include the number (and %) of patients who receive pharmacotherapy for AUD or are referred for AUD services. Sample size calculations determined that 35 practices are needed to detect a 10% increase in the main outcome (percent screened for unhealthy alcohol use) over 6 months. DISCUSSION: A successful intervention would significantly reduce morbidity among adults from unhealthy alcohol use by increasing counseling and other treatment opportunities. The study will produce important evidence about the effect of practice facilitation on uptake of evidence-based screening, counseling, and pharmacotherapy for unhealthy alcohol use when delivered on a large scale to small and medium-sized practices. It will also generate scientific knowledge about whether embedded telehealth services can improve the use of evidence-based screening and interventions for practices with slower uptake. The results of this rigorously conducted evaluation are expected to have a positive impact by accelerating the dissemination and implementation of evidence related to unhealthy alcohol use into primary care practices. TRIAL REGISTRATION: ClinicalTrials.gov NCT04317989 . Registered on March 23, 2020.

Pre-Post Evaluation of Collaborative Oncology Palliative Care for Patients With Stage IV Cancer.

CONTEXT: The Collaborative Care Model improves care processes and outcomes but has never been tested for palliative care. OBJECTIVES: To develop and evaluate a model of collaborative oncology palliative care for Stage IV cancer. METHODS: We conducted a pre-post evaluation of Collaborative Oncology Palliative Care (CO-Pal), enrolling patients with Stage IV lung, breast or genitourinary cancers and acute illness hospitalization. CO-Pal has 4 components: 1) oncologist communication skills training; 2) patient tracking; 3) palliative care needs assessment; and 4) care coordination stratified by high vs. low palliative care need. Health record reviews from hospital admission through 60 days provided data on outcomes - goals-of-care discussions (primary outcome), advance care planning, symptom treatment, specialty palliative care and hospice use, and hospital transfers. RESULTS: We enrolled 256 patients (n = 114 pre and n = 142 post-intervention); 60-day mortality was 32%. Comparing patients pre vs post-intervention, CO-Pal did not increase overall goals-of-care discussions, but did increase advance care planning (48% vs 63%, P = 0.021) and hospice use (19% vs 31%, P = 0.034). CO-Pal did not impact symptom treatment, overall treatment plans, or 60-day hospital transfers. During the intervention phase, high-need vs low-need patients had more goals-of-care discussions (60% vs. 15%, P < 0.001) and more use of specialty palliative care (64% vs 22%, P < 0.001) and hospice (44% vs 16%, P < 0.001). CONCLUSION: Collaborative oncology palliative care is efficient and feasible. While it did not increase overall goals-of-care discussions, it was effective to increase overall advance care planning and hospice use for patients with Stage IV cancer.

Transition Readiness Not Associated With Measures of Health in Youth With IBD.

BACKGROUND: It remains unclear how transition readiness is associated with various domains of health in children and young adults. Our objective was to describe the transition readiness of children and young adults with inflammatory bowel disease (IBD) and examine its associations with demographic factors, IBD activity, and measures of physical, psychological, and social health. METHODS: We recruited children ages 12 to 17 and young adults ages 18 to 20 from 2 internet-based cohorts sponsored by the Crohn's & Colitis Foundation. Participants self-reported demographics, IBD activity, transition readiness, health-related quality of life, and Patient-Reported Outcomes Information Systems domains of physical, psychological, and social health. RESULTS: Among 361 pediatric and 119 adult participants, age and female sex were associated with transition readiness. The association was greater in the pediatric cohort. Having IBD in remission was associated with worse transition readiness in the pediatric cohort only (beta = 0.3; P = 0.003). Health-related quality of life and Patient-Reported Outcomes Information Systems measures of fatigue, pain interference, and sleep disturbance were not associated with transition readiness in either children or adults. We observed few small associations between psychological or social health and transition readiness. Better transition readiness was associated with greater anxiety in adults (beta = -0.02; P = 0.02) and greater peer relationships among children (beta = 0.01; P = 0.009). CONCLUSIONS: In children and young adults with IBD, transition readiness was associated with older age and female sex. Associations between transition readiness and physical, psychological, and social health were either small, inconsistent across age groups, or nonexistent.

PROMIS pediatric measures validated in a longitudinal study design in pediatric oncology.

PURPOSE: This study assessed the responsiveness to change over time and theorized associations of Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric measures in children and adolescents in treatment for cancer to determine measure readiness for use in cancer clinical trials. METHODS: We administered eight PROMIS (three symptom, two psychological, and three performance) pediatric short-form measures and the Symptom Distress Scale (SDS) to 96 pediatric oncology patients at three time points during a course of chemotherapy. We assessed responsiveness using paired t tests and generalized estimating equation (GEE) models, calculated standardized response mean (SRM) values for PROMIS measures, and examined scores over three data points (T1-T3). Guided by the theory of unpleasant symptoms (TOUS), we examined associations among the PROMIS measures, the SDS, and other variables using GEE. RESULTS: The paired t tests showed statistically significant changes in two psychological measures and one performance measure from T1 to T2; three symptom, two psychological and two performance measures from T2 to T3; and three symptom and two psychological measures from T1 to T3. Findings from GEE models indicate PROMIS pediatric measures had statistically significant short-term and long-term changes, controlling for demographic and clinical variables. One performance measure did not achieve significant change at any time point. We found positive support for theorized relationships in the TOUS. CONCLUSIONS: Most of the PROMIS pediatric measures demonstrated changes over time and had significant relationships as theorized, thus supporting concurrent and construct validity of these measures when administered to pediatric oncology patients during a course of chemotherapy. This evidence supports the measures' readiness for use in clinical trials.

A Longitudinal Study of PROMIS Pediatric Symptom Clusters in Children Undergoing Chemotherapy.

CONTEXT: Children in treatment for cancer experience multiple, troubling, and interrelated symptoms. Analyzing the interrelatedness of symptoms and how that changes during treatment could yield clinically relevant patient profiles to guide patient care. OBJECTIVES: The aims were to identify pediatric profiles with respect to Patient-Reported Outcomes Measurement Information System® (PROMIS®; U.S. Department of Health and Human Services, National Institutes of Health) symptom measures, changes in profile status throughout a chemotherapy cycle, and if a baseline single-item fatigue measure could significantly predict symptom profile status and its changes. METHODS: In a longitudinal, single-site, three data point (T1, T2, and T3) design, children between 8 and 18 years completed the PROMIS Pediatric short form measures for fatigue, depression, anxiety, and pain and one fatigue item from the Symptom Distress Scale. Latent profile analysis and latent transition analysis were conducted. RESULTS: About 96 children participated; 58.3% were between 13 and 18 years, and 54.2% were males. Two latent profiles (less severe symptoms and severe symptoms) were identified. The prevalence of the severe symptom profile remained relatively unchanged from T1 to T2 but significantly declined at T3. The baseline single-item fatigue score significantly predicted the child's profile membership and its changes. CONCLUSION: Children experiencing troubling symptoms during cancer treatment are heterogeneous. With respect to the PROMIS symptom measures, two a priori unknown distinct latent profiles of patients were identified in a course of chemotherapy, and the transitions in the profile status were significantly predicted by a baseline single-item fatigue measure.

Assessing responsiveness over time of the PROMIS® pediatric symptom and function measures in cancer, nephrotic syndrome, and sickle cell disease.

PURPOSE: Previous studies provided evidence for the validity of the PROMIS Pediatric measures in cross-sectional studies. This study evaluated the ability of the PROMIS Pediatric measures to detect change over time in children and adolescents with cancer, nephrotic syndrome (NS), or sickle cell disease (SCD). METHODS: Participants (8-17 years) completed measures of fatigue, pain interference, anger, anxiety, depressive symptoms, mobility, upper extremity, and peer relationships at three or four time points (T1-T4). Between T1 and T2, children with cancer received chemotherapy and children with SCD experienced a pain exacerbation. Children with NS were first assessed during active disease (T2), with T3 and T4 conducted at disease remission. For the primary analysis of responsiveness, we expected better scores at T3 (recovery) compared to T2 (event) for all diseases. T1 and T4 are also expected to have better scores than T2. Linear mixed models were used and adjusted for time, gender, age, race/ethnicity, education, comorbid conditions, and disease. RESULTS: Enrolled were 96 children with cancer, 121 children with SCD, and 127 children with NS. Fatigue, pain interference, mobility, and upper extremity scores worsened from T1 (baseline) to T2 (event) (p < 0.01), and significantly improved from T2 to T3 and T4 (p < 0.01). Similarly, anxiety and depressive symptoms significantly improved from T2 to T3 and T4 (p < 0.01). CONCLUSIONS: This study provides evidence for the responsiveness of seven PROMIS Pediatric measures to clinical disease state in three chronic illnesses. The findings support use of PROMIS Pediatric measures in clinical research.

Comparison of Legacy Fatigue Measures With the PROMIS Pediatric Fatigue Short Form
.

OBJECTIVES: To compare Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Fatigue Short Form measures and legacy patient-reported outcome fatigue measures to capture cancer-related fatigue change in pediatric patients with cancer. 
. SAMPLE & SETTING: 96 racially diverse children and adolescents with cancer. The study occurred in a 32-bed inpatient unit and three regional outpatient clinics.
. METHODS & VARIABLES: The Fatigue Scale-Child, Fatigue Scale-Adolescent, and the PROMIS Pediatric Fatigue Short Form measures were administered at three time points during chemotherapy. Descriptive, correlational, psychometric, and receiver operating characteristic (ROC) curve analyses were conducted. The variable was pediatric patient-reported fatigue.
. RESULTS: All measures were positively correlated at each time point. ROC curves were not statistically different from each other at any data point. 
. IMPLICATIONS FOR NURSING: Nurses have psychometrically strong options for measuring cancer-related fatigue in pediatric patients with cancer, but the PROMIS Pediatric Fatigue Short Form is applicable to more age groups.

Impaired Patient-Reported Outcomes Predict Poor School Functioning and Daytime Sleepiness: The PROMIS Pediatric Asthma Study.

OBJECTIVE: Poor asthma control in children is related to impaired patient-reported outcomes (PROs; eg, fatigue, depressive symptoms, anxiety), but less well studied is the effect of PROs on children's school performance and sleep outcomes. In this study we investigated whether the consistency status of PROs over time affected school functioning and daytime sleepiness in children with asthma. METHODS: Of the 238 children with asthma enrolled in the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Asthma Study, 169 children who provided survey data for all 4 time points were used in the analysis. The child's PROs, school functioning, and daytime sleepiness were measured 4 times within a 15-month period. PRO domains included asthma impact, pain interference, fatigue, depressive symptoms, anxiety, and mobility. Each child was classified as having poor/fair versus good PROs per meaningful cut points. The consistency status of each domain was classified as consistently poor/fair if poor/fair status was present for at least 3 time points; otherwise, the status was classified as consistently good. Seemingly unrelated regression was performed to test if consistently poor/fair PROs predicted impaired school functioning and daytime sleepiness at the fourth time point. RESULTS: Consistently poor/fair in all PRO domains was significantly associated with impaired school functioning and excessive daytime sleepiness (Ps < .01) after controlling for the influence of the child's age, sex, and race/ethnicity. CONCLUSIONS: Children with asthma with consistently poor/fair PROs are at risk of poor school functioning and daytime sleepiness. Developing child-friendly PRO assessment systems to track PROs can inform potential problems in the school setting.

The Association of English Functional Health Literacy and the Receipt of Mammography among Hispanic Women Compared to Non-Hispanic U.S.-Born White Women.

BACKGROUND: Breast cancer is a leading cause of cancer death among Hispanic women in the U.S., and mammography is the recommended screening for early diagnosing and preventing breast cancer. Several barriers exist to influence mammography utilization including poor health literacy. However, it is unclear whether the effect of health literacy on mammography utilization is consistent between Hispanic women and non-Hispanic White women. The main objective of this study was to examine association between functional health literacy and the receipt of mammography among Hispanic women compared to non-Hispanic White women in the U.S. METHODS: A cross-sectional design using participants engaged in the National Assessment of Adult Literacy. Study sample comprised of 4,249 Hispanic and non-Hispanic U.S.-born White women ≥ 40 years of age who completed the functional health literacy assessment. Regression analyses were performed to test the association between health literacy and receipt of mammography. Among Hispanic women, analyses considered the influence of language-preference acculturation. RESULTS: Equal percentages of Hispanic (59.3%) and non-Hispanic White (60.6%) women received mammography. After adjusting for covariates, health literacy was positively associated with receiving mammography among U.S.-born White women (ß = 0.14, p<0.001), but negatively associated with mammography among Hispanic women (ß = -0.13, p<0.001). Analyses stratified by acculturation status revealed that higher health literacy was associated with lower mammography among language-preference acculturated Hispanic women (ß = -0.48, p<0.001), yet an opposite result among less acculturated Hispanic women (ß = 0.08, p<0.001). CONCLUSION: Functional health literacy has different associations with mammography depending upon ethnicity. Language-preference acculturation may explain the differing association.

Patient-Reported Outcomes Measurement Information System in Children with Crohn's Disease.

OBJECTIVES: To assess the criterion validity and responsiveness of Patient-Reported Outcomes Measurement Information System (PROMIS) in a web-based cohort of children with Crohn's disease. STUDY DESIGN: We recruited children with Crohn's disease (ages 9-17 years) and their parents from the web-based Crohn's and Colitis Foundation of America Kids and Teens Study cohort. Upon entry into the cohort and 6 months later, children self-reported Crohn's disease activity, health-related quality of life, and PROMIS domains of pain interference, anxiety, depression, fatigue, and peer relationships. RESULTS: Mean PROMIS scores for the 276 participating patients were worse among those with worse self-reported Crohn's disease activity (per Short Crohn's Disease Activity Index, P < .005 for all), Crohn's disease activity in the prior 6 months (per Manitoba Index, P < .01 for all), and health-related quality of life (per IMPACT-35, P < .001 for all). One hundred forty-three patients and their parents completed follow-up questionnaires, 75% of whom reported stable disease activity. Those with improved Crohn's disease activity reported improved PROMIS scores, and those with worsened Crohn's disease activity reported worse PROMIS scores for all domains except anxiety. All participants reported improved anxiety from baseline, but those with stable or worsened Crohn's disease activity reported less improvement (P = .07). CONCLUSIONS: PROMIS scores were significantly associated with Crohn's disease activity in a linear and clinically meaningful manner, and responded to change in Crohn's disease activity over a 6-month period. This supports the criterion validity and responsiveness of pediatric PROMIS.

Initial Evaluation of the Pediatric PROMIS® Health Domains in Children and Adolescents With Sickle Cell Disease.

BACKGROUND: The Patient Reported Outcomes Measurement Information System (PROMIS®) has developed pediatric self-report scales measuring several unidimensional health attributes (domains) suitable for use in clinical research, but these measures have not yet been validated in sickle cell disease (SCD). PROCEDURE: A convenience sample of SCD children, aged 8-17 years, from two sickle cell programs was recruited at routine clinic visits, including some for hydroxyurea monitoring or monthly transfusions. Children completed PROMIS pediatric items using an online data collection platform, the PROMIS Assessment Center Web site. RESULTS: A total of 235 participants (mean age 12.5 ± 2.8 years, 49.8% female) participated in the study. Adolescents (ages 12-17 years) reported significantly higher pain interference and depressive symptoms, and worse lower extremity physical functioning domain scores compared to younger children (ages 8-11 years). Female participants reported significantly higher pain interference, fatigue, and depressive symptoms, and worse lower extremity physical functioning domain scores compared with their male counterparts. Participants with hip or joint problems that limited usual activities reported significantly higher pain, fatigue, and depressive symptoms scores, and worse upper/lower extremity physical functioning scores as did participants who had experienced sickle pain in the previous 7 days. CONCLUSIONS: PROMIS pediatric measures are feasible in a research setting and identify expected differences in known group comparisons in a sample of SCD children. The large domain score differences between those with or without SCD-related complications suggest the potential usefulness of these measures in clinical research, but further validation studies are needed, particularly in clinical practice settings.

Responsiveness of PROMIS® Pediatric Measures to Hospitalizations for Sickle Pain and Subsequent Recovery.

BACKGROUND: The Patient-Reported Outcomes Measurement Information System(®) (PROMIS(®) ) created pediatric self-report scales measuring a variety of health attributes (domains), but their responsiveness to changes in health status has not yet been determined in children with sickle cell disease (SCD). PROCEDURE: A convenience cohort of symptomatic SCD children, aged 8-17 years, was asked to complete PROMIS pediatric scales at an initial clinic visit, at the end of a subsequent hospitalization for sickle pain, at a subsequent clinic visit or at home 2-3 weeks after hospitalization, and at a clinic visit 1-2 years after their initial assessment. RESULTS: A total of 121 participants (mean age 12.5 ± 3.1 years, 56.2% female) participated in the study. Pain interference and fatigue domain scores were elevated at baseline, increased substantially during hospitalization, and largely returned to baseline by the recovery period, whereas the depressive symptoms, anger, and anxiety domain scores displayed a less pronounced elevation during hospitalizations and a slower return to baseline levels. The two physical functioning scales showed a substantial decline in response to hospitalization, but only modest improvements at the recovery assessment, likely representing incomplete recovery. CONCLUSIONS: Several PROMIS pediatric measures were responsive to changes in health status associated with occurrence and resolution of acute vaso-occlusive pain requiring hospitalization. The substantial differences in these domains during SCD-related pain exacerbations support their potential usefulness in clinical research or in clinical practice. Further studies to characterize variations in symptom patterns over time may provide insights into strategies for more effective management of sickle pain.

Cancer Care Delivery Research: Building the Evidence Base to Support Practice Change in Community Oncology.

Understanding how health care system structures, processes, and available resources facilitate and/or hinder the delivery of quality cancer care is imperative, especially given the rapidly changing health care landscape. The emerging field of cancer care delivery research (CCDR) focuses on how organizational structures and processes, care delivery models, financing and reimbursement, health technologies, and health care provider and patient knowledge, attitudes, and behaviors influence cancer care quality, cost, and access and ultimately the health outcomes and well-being of patients and survivors. In this article, we describe attributes of CCDR, present examples of studies that illustrate those attributes, and discuss the potential impact of CCDR in addressing disparities in care. We conclude by emphasizing the need for collaborative research that links academic and community-based settings and serves simultaneously to accelerate the translation of CCDR results into practice. The National Cancer Institute recently launched its Community Oncology Research Program, which includes a focus on this area of research.

Comparison of brief health literacy screens in the emergency department.

Measuring health literacy efficiently yet accurately is of interest both clinically and in research. The authors examined 6 brief health literacy measures and compared their categorization of patient health literacy levels and their comparative associations with patients' health status. The authors assessed 400 emergency department patients with the Short Test of Functional Health Literacy in Adults, the Newest Vital Sign, Single Item Literacy Screen, brief screening questions, Rapid Estimate of Adult Literacy in Medicine-Revised, and the Medical Term Recognition Test. The authors analyzed data using Spearman's correlation coefficients and ran separate logistic regressions for each instrument for patient self-reported health status. Tests differed in the proportion of patients' skills classified as adequate, but all instruments were significantly correlated; instruments targeting similar skills were more strongly correlated. Scoring poorly on any instrument was significantly associated with worse health status after adjusting for age, sex and race, with a score in the combined inadequate/marginal category on the Short Test of Functional Health Literacy in Adults carrying the largest risk (OR = 2.94, 95% CI [1.23, 7.05]). Future research will need to further elaborate instrument differences in predicting different outcomes.

Development and validation of the Proxy-Reported Pulmonary Outcomes Scale for premature infants.

OBJECTIVE: Test the feasibility of using a bedside nurse-reported tool (Proxy-Reported Pulmonary Outcome Scale, PRPOS) for evaluating the severity of bronchopulmonary dysplasia (BPD) by assessing functional, disease-related measures. STUDY DESIGN: Bedside nurses tested the 26-item instrument by observing preterm infants (23-30 weeks at birth) at 36 to 37(4/7) weeks postmenstrual age before, during, and after a care time. We analyzed item reliability, validity, and model fit to determine the six items to include in the final measurement tool. RESULT: We completed assessments on 188 preterm infants. The frequency of an abnormal PRPOS item score increased with increasing National Institute of Child Health and Development (NICHD) BPD category. The six-candidate items produced an internally consistent scale. Addition of the NICHD BPD classification increased reliability moderately; addition of feeding items decreased reliability. The PRPOS score correlated with postmenstrual age at discharge. Infants discharged on oxygen or diuretics had higher median PRPOS scores than did infants who were not prescribed those therapies. CONCLUSION: The PRPOS is an internally consistent, proxy-reported measure of respiratory function in premature infants, based on observable, functional performance measures. Initial testing demonstrates known-groups validity and ongoing testing can assess predictive validity.

PROMIS(®) pediatric self-report scales distinguish subgroups of children within and across six common pediatric chronic health conditions.

PURPOSE: To conduct a comparative analysis of eight pediatric self-report scales for ages 8-17 years from the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS(®)) in six pediatric chronic health conditions, using indicators of disease severity. METHODS: Pediatric patients (N = 1454) with asthma, cancer, chronic kidney disease, obesity, rheumatic disease, and sickle cell disease completed items from the PROMIS pediatric mobility, upper extremity functioning, depressive symptoms, anxiety, anger, peer relationships, pain interference, and fatigue self-report scales. Comparisons within the six pediatric chronic health conditions were conducted by examining differences in groups based on the disease severity using markers of severity that were specific to characteristics of each disease. A comparison was also made across diseases between children who had been recently hospitalized and those who had not. RESULTS: In general, there were differences in self-reported health outcomes within each chronic health condition, with patients who had higher disease severity showing worse outcomes. Across health conditions, when children with recent hospitalizations were compared with those who had not been hospitalized in the past 6 months, we found significant differences in the expected directions for all PROMIS domains, except anger. CONCLUSIONS: PROMIS measures discriminate between different clinically meaningful subgroups within several chronic illnesses. Further research is needed to determine the responsiveness of the PROMIS pediatric scales to change over time.

Functional health literacy, chemotherapy decisions, and outcomes among a colorectal cancer cohort.

BACKGROUND: Functional health literacy is essential for the self-management of chronic diseases and preventive health behaviors. Patients with cancer who have a low level of health literacy may be at greater risk for poor care and poor outcomes. METHODS: We assessed health literacy using the Short Test of Functional Health Literacy in Adults in 347 participants with colorectal cancer who were nested within a prospective observational study of system, health care provider, and participant characteristics influencing cancer outcomes. RESULTS: Having adequate health literacy increased the likelihood that participants with stage 3/4 disease received chemotherapy (odds ratio, 3.29; 95% confidence interval, 1.23-8.80) but had no effect on cancer stage at diagnosis or vital status at last observation during postenrollment follow-up. No difference was seen in health literacy status regarding participant beliefs and preferences about chemotherapy among those with stage 3/4 disease, nor in participant roles in deciding whether to receive chemotherapy. CONCLUSIONS: Patients with lower levels of health literacy were less likely to receive chemotherapy compared with participants with higher levels of health literacy. Therefore, clear communication related to key health care decisions may lead to fewer disparities due to a patient's level of health literacy.

Using item response theory to enrich and expand the PROMIS® pediatric self report banks.

BACKGROUND: The primary objective was to enhance the content coverage of some of the pediatric self-report item banks for ages 8-17 years from the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS®), and extend the range of precise measurement to higher levels of physical functioning. METHODS: Data from 1,419 pediatric patients with cancer, chronic kidney disease, obesity, rehabilitation needs, rheumatic disease, and sickle cell disease were combined with item responses from the original standardization sample of 3,048 children to calibrate new items for the pediatric PROMIS Anger, Anxiety, Depressive Symptoms, Pain Interference, Fatigue, and physical functioning Upper Extremity and Mobility scales. Simultaneous or concurrent calibration using the graded item response theory model placed all of the items on the same scale. RESULTS: Twenty-two of 28 potential new items were added across the seven scales. A recommended short form was proposed for the Anger scale, and the recommended short forms for the Anxiety and Depressive Symptoms scales were revised. Unfortunately, we were not particularly successful at extending the range of measurement for the physical functioning banks. CONCLUSIONS: The present study expanded PROMIS pediatric item banks to add new content and to increase the range of measurement. Using item response theory, the banks were revised and expanded without changing the underlying scale of measurement. For Anger, Anxiety, and Depressive Symptoms, we successfully added new content that may render those banks more robust and flexible.