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Objective: The Patient-Reported Outcomes Measurement Information System (PROMIS)-Plus-Osteoarthritis of the Knee (OAK) profile integrates universal PROMIS items with knee-specific items across 13 domains. We evaluated the psychometric properties of a subset of six domains associated with quality of life in people with OAK., Study Design and Setting: In a cross-sectional study of OAK patients (n=600), we estimated reliability using Pearson and Spearman correlations with Knee Injury and Osteoarthritis Outcome Score (KOOS) subscores and known-groups validity with PROMIS Global Health. Measure responsiveness was tested via paired t-tests in a longitudinal study (n=238), pre/post total knee replacement., Results: Across the six domains, internal consistency reliability (Cronbach's alpha) was 0.77-0.95 and test-retest reliability (intraclass correlation coefficients) was ≥0.90. Correlations with Knee Injury and Osteoarthritis Outcome Score (KOOS) subscores and PROMIS Global supported convergent and divergent validity. Known-groups validity testing revealed better scores in all domains for high vs. low global status groups, and knee-specific items added value in physical function and pain. All domains reflected (p<0.001) better health status scores at follow up., Conclusion: The six PROMIS-Plus-OAK profile domains demonstrated good psychometric characteristics. The measure integrates universal and knee-specific content to provide enhanced relevance, measurement precision and efficient administration for patient care and clinical research., (Copyright © 2021. Published by Elsevier Inc.)

Background: There is a need for valid self-report measures of core health-related quality of life (HRQoL) domains., Objective: To derive brief, reliable and valid health profile measures from the Patient Reported Outcomes Measurement Information System ® (PROMIS ® ) item banks., Methods: Literature review, investigator consensus process, item response theory (IRT) analysis, and expert review of scaling results from multiple PROMIS data sets. We developed 3 profile measures ranging in length from 29 to 57 questions. These profiles assess important HRQoL domains with highly informative subsets of items from respective item banks and yield reliable information across mild-to-severe levels of HRQoL experiences. Each instrument assesses the domains of pain interference, fatigue, depression, anxiety, sleep disturbance, physical function, and social function using 4-, 6-, and 8-item short forms for each domain, and an average pain intensity domain score, using a 0-10 numeric rating scale., Results: With few exceptions, all domain short forms within the profile measures were highly reliable across at least 3 standard deviation (30 T-score) units and were strongly correlated with the full bank scores. Construct validity with ratings of general health and quality of life was demonstrated. Information to inform statistical power for clinical and general population samples is also provided., Conclusions: Although these profile measures have been used widely, with summary scoring routines published, description of their development, reliability, and initial validity has not been published until this article. Further evaluation of these measures and clinical applications are encouraged., (Copyright © 2019 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Objectives: The purpose of this study was to evaluate the responsiveness to change of the PROMIS negative affect measures (depression, anxiety, and anger) using longitudinal data collected in six chronic health conditions., Study Design and Setting: Individuals with major depressive disorder (MDD), back pain, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF), and cancer completed PROMIS negative affect instruments as computerized adaptive test or as fixed-length short form at baseline and a clinically relevant follow-up interval. Participants also completed global ratings of health. Linear mixed effects models and standardized response means (SRM) were estimated at baseline and follow-up., Results: A total of 903 individuals participated (back pain, n = 218; cancer, n = 304; CHF, n = 60; COPD, n = 125; MDD, n = 196). All three negative affect instruments improved significantly for treatments of depression and pain. Depression improved for CHF patients (anxiety and anger not administered), whereas anxiety improved significantly in COPD groups (stable and exacerbation). Response to treatment was not assessed in cancer. Subgroups of patients reporting better or worse health showed a corresponding positive or negative average SRM for negative affect across samples., Conclusion: This study provides evidence that the PROMIS negative affect scores are sensitive to change in intervention studies in which negative affect is expected to change. These results inform the estimation of meaningful change and enable comparative effectiveness research., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Successful management of complex conditions such as systemic lupus erythematosus (SLE) and comorbid conditions benefit from patient-reported outcomes (PRO). Measuring health-related quality of life with PROs provides SLE patients with an opportunity to participate in their treatment and to facilitate better communication with the multidisciplinary team involved in their care. Health outcomes research has produced well-validated instruments that can be used across diseases; others have been specifically developed for SLE. The use of generic and SLE-specific PROs depends on needs, including population monitoring, treatment decision making, clinical trials research, and for evaluating and comparing the effect of therapies., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Context: Lung cancer patients experience multiple, simultaneous symptoms related to their disease and treatment that impair functioning and health-related quality of life (HRQL). Computer technology can reduce barriers to nonsystematic, infrequent symptom assessment and potentially contribute to improved patient care., Objectives: To evaluate the efficacy of technology-based symptom monitoring and reporting in reducing symptom burden in patients with advanced lung cancer., Methods: This was a prospective, multisite, randomized controlled trial. Two hundred fifty-three patients were enrolled at three sites and randomized to monitoring and reporting (MR) or monitoring alone (MA). Patients completed questionnaires at baseline, 3, 6, 9, and 12 weeks and symptom surveys via interactive voice response weekly for 12 weeks. MR patients' clinically significant symptom scores generated an e-mail alert to the site nurse for management. The primary endpoint was overall symptom burden; secondary endpoints included HRQL, treatment satisfaction, symptom management barriers, and self-efficacy., Results: This randomized controlled trial failed to demonstrate efficacy of symptom monitoring and reporting in reducing symptom burden compared with monitoring alone in lung cancer. HRQL declined over 12 weeks in both groups (P < 0.006 to P < 0.025); at week 12, treatment satisfaction was higher in MA than MR patients (P < 0.012, P < 0.027). Adherence to weekly calls was good (82%) and patient satisfaction was high., Conclusion: Feasibility of using a technology-based system for systematic symptom monitoring in advanced lung cancer patients was demonstrated. Future research should focus on identifying patients most likely to benefit and other patient, provider, and health system factors likely to contribute to the system's success., (Copyright © 2014 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)

Objective: Develop and validate a health-related quality-of-life (measure for patients with acute and chronic leukemia., Methods: The study consisted of two phases: scale construction and scale validation. For the item-generation phase, a summary of the literature combined with qualitative results from item-generation interviews with 29 acute or chronic leukemia patients and 16 health care providers yielded an initial item pool reflecting leukemia-specific concerns and symptoms. Items underwent iterations of review and reduction according to defined retention criteria to support content validity, as defined by priority concerns of patients. Seventeen final leukemia-specific items were combined with the Functional Assessment of Cancer Therapy-General to create the FACT-Leukemia (FACT-Leu) scale. For the validation phase, 79 individuals with acute or chronic leukemia completed questionnaires at three time points., Results: All FACT-Leu subscale and aggregated scores showed high internal consistency (αs ranging from 0.75 to 0.96). Test-retest reliability was adequate for all subscales (intraclass correlation range 0.765-0.890). The FACT-Leu scale demonstrated good convergent validity, with significant correlations with quality-of-life criteria and performance status, in the expected direction. FACT-Leu subscale scores were significantly different among the three performance status change groups, suggesting good responsiveness to change., Conclusions: The FACT-Leu scale is a valid, reliable, and efficient measure of leukemia-specific health-related quality of life for acute and chronic disease., (Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Background: Advanced lung cancer is often symptomatic; thus the goals of treatment include maintenance of function and palliation of symptoms. Symptom management requires accurate systematic symptom assessment. This study, which focused on lung cancer, is part of a larger study to obtain patient input that, in combination with previously obtained physician and nurse input, was used to develop symptom indexes for 11 advanced cancers., Participants and Methods: Fifty patients with advanced lung cancer were recruited from National Comprehensive Cancer Network (NCCN) member institutions and community support agencies; 10 physician experts were recruited from NCCN institutions. Patients reported symptoms associated with their disease in open-ended format and then completed a checklist of symptoms, rating their 5 most important symptoms. Patient and provider ratings of symptom importance were tabulated to construct the NCCN-Functional Assessment of Cancer Therapy (FACT) Lung Symptom Index-17 (NFLSI-17). Patients also completed the Functional Assessment of Cancer Therapy-Lung (FACT-L), which was used to preliminarily validate the NFLSI-17., Results: Based on combined patient, physician, and nurse input, the NFLSI-17 is composed of 17 priority symptoms, 11 that are disease related, 3 that are treatment related, and 3 that are related to general functional well-being (FWB). Data on 15 of 17 NFLSI-17 symptoms showed good internal consistency (alpha = 0.74) and strong association with the FACT-L total and most subscale scores (r = 0.42-0.92). Both the NFLSI-15 (F(2,47) = 4.46; P = .017) and the NFLSI-disease related subscale (DRS) (F(2,47) = 5.56; P = .007) significantly discriminated patients among performance status groups., Conclusion: The NFLSI-17 reflects the most important patient- and clinician-rated targets of chemotherapy for advanced lung cancer; further validation will follow., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Objective: Chronic obstructive pulmonary disease (COPD) is a progressive disease with functional decline leading to disability. Dyspnea, the prominent symptom, can be measured using existing measures, but a lack of consensus about standardization of dyspnea measurement remains. We examined the psychometric performance of two item-response theory-based (IRT) measures of dyspnea and related functional limitations (FLs) in patients with COPD and simulated computerized adaptive testing (CAT) of the banks to determine the number of questions required to achieve high precision., Methods: A total of 102 patients completed banks measuring dyspnea and FLs (33 items), from which the 10-item dyspnea and FL short forms were scored as well as other self-report measures of respiratory and physical function and emotional distress. A subset of patients completed the banks 7 to 10 days later. Pulmonary function test results were obtained from medical charts., Results: The 33-item banks and 10-item short forms had excellent internal consistency (alphas >0.9) and test-retest reliability (intraclass correlation coefficients >0.89). Patients sorted by severity level on the Medical Research Council scale were differentiated by item banks (P < 0.001) and the short forms (P < 0.01). The banks and short forms were also associated with related measures of dyspnea (e.g., Baseline Dyspnea Index, r = 0.47-0.53), physical function (e.g., 36-Item Short Form Health Survey, r = -0.83 to -0.86) and forced expiratory volume in 1 second (r = -0.32 to -0.35). On average, CAT required 4 and 5 items for accurate measurement of dyspnea and FLs, respectively., Conclusion: The Functional Assessment of Chronic Illness Therapy-Dyspnea short forms and banks provide options for brief, psychometrically sound measures of dyspnea and/or FLs in COPD., (Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Objectives: Chronic obstructive pulmonary disease is a major global health problem. Although several patient-reported outcome (PRO) measures of chronic obstructive pulmonary disease exist, none were developed using patient-driven concept development. We developed an item bank for dyspnea severity and related functional limitations on the basis of a PRO conceptual framework derived from patient input., Methods: We identified a large pool of existing items based on a conceptual framework and literature review. Using patient and expert review panels and an item refinement/modification process, we developed an item bank aligned with the conceptual framework, which subsequently underwent psychometric testing via an online Internet panel of dyspnea patients (N = 608)., Results: Exploratory factor analysis suggested a dominant first factor accounting for about 78% of the total variance. Confirmatory factor analysis supported a unidimensional model. Item response theory analysis demonstrated good model fit, and differential item functioning analyses indicated that the 33-item scale showed potential for measurement equivalence across sex. A 10-item short form produced comparable scores (r = 0.98) and a computerized adaptive-testing simulation indicated efficient measurement with fewer items (mean 4.65 items)., Conclusions: An efficient patient-reported measure of dyspnea severity and related functional limitations, based on a patient-driven PRO conceptual framework, is now available for further validation and use., (Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Objectives: Patient-reported outcomes (PROs) are essential when evaluating many new treatments in health care; yet, current measures have been limited by a lack of precision, standardization, and comparability of scores across studies and diseases. The Patient-Reported Outcomes Measurement Information System (PROMIS) provides item banks that offer the potential for efficient (minimizes item number without compromising reliability), flexible (enables optional use of interchangeable items), and precise (has minimal error in estimate) measurement of commonly studied PROs. We report results from the first large-scale testing of PROMIS items., Study Design and Setting: Fourteen item pools were tested in the U.S. general population and clinical groups using an online panel and clinic recruitment. A scale-setting subsample was created reflecting demographics proportional to the 2000 U.S. census., Results: Using item-response theory (graded response model), 11 item banks were calibrated on a sample of 21,133, measuring components of self-reported physical, mental, and social health, along with a 10-item Global Health Scale. Short forms from each bank were developed and compared with the overall bank and with other well-validated and widely accepted ("legacy") measures. All item banks demonstrated good reliability across most of the score distributions. Construct validity was supported by moderate to strong correlations with legacy measures., Conclusion: PROMIS item banks and their short forms provide evidence that they are reliable and precise measures of generic symptoms and functional reports comparable to legacy instruments. Further testing will continue to validate and test PROMIS items and banks in diverse clinical populations., (Copyright © 2010 Elsevier Inc. All rights reserved.)

Objectives: The Patient-Reported Outcomes Measurement Information System (PROMIS) allows assessment of the impact of chronic conditions on health-related quality of life (HRQL) across diseases. We report on the HRQL impact of individual and comorbid conditions as well as conditions that are described as limiting activity., Study Design and Setting: Data were collected through online and clinic recruitment as part of the PROMIS item calibration sample (n=21,133). Participants reported the presence or absence of 24 chronic health conditions and whether their activity was limited by each condition., Results: Across health status domains, the presence of a chronic condition was associated with poorer scores than those without a diagnosis, particularly for those individuals who reported that their condition was disabling. The magnitude of detriment in HRQL was more pronounced for individuals with two or more chronic conditions and could not be explained by sociodemographic factors. Patterns of HRQL deficits varied across disease and comorbidity status., Conclusion: The impact of chronic conditions, particularly when experienced with comorbid disease, is associated with detriments in HRQL. The negative impact on HRQL varies across symptoms and functional areas within a given condition., (Copyright © 2010 Elsevier Inc. All rights reserved.)

Objectives: Identify important patient-reported concepts of dyspnea and associated activities to develop a dyspnea-specific conceptual model for chronic obstructive pulmonary disease (COPD)., Methods: Using grounded theory methodologies, we identified key concepts through interviews with 25 COPD patients, review of scientific literature, and input from 22 experts., Results: Constant comparative thematic analysis of data suggested five primary components of the dyspnea experience: breathlessness, fatigue, activity modification, activity limitation, and emotional response. Two major influences on dyspnea were described as individual exertion and exposure to environmental factors. Patients described a sense of dyspnea-related fear, and reported distress over the impact of dyspnea on health and activity limitation. They emphasized coping via behavioral strategies and medication, and reported that dyspnea caused the stopping or scaling back of activities, taking more time to do things and using adaptive measures or equipment. No existing model of dyspnea in COPD incorporated all of these concepts. We, therefore, developed a dyspnea-specific conceptual model in which the most proximal of concepts (dyspnea symptoms) can impair function and are mediated by personal and environmental factors., Conclusion: Patient and expert input guided the development of a comprehensive dyspnea-specific conceptual model for COPD which will inform the design of future patient-reported outcome measurement tools used to assess dyspnea and related functional limitations.

Objective: To determine the current knowledge of postpartum women's sleep patterns, sleep disturbances, consequences of sleep disturbances, and known strategies for prevention in order to provide best practice recommendations for health care providers., Data Sources: A literature search from 1969 through February 2008 was conducted using the CINHL, Index of Allied Health Literature, Ovid, PsycINFO, and PubMed electronic databases in addition to reference lists from selected articles and other key references. Search terms included sleep, postpartum, sleep deprivation, and sleep disturbance., Study Selection: A critical review of all relevant articles from the data sources was conducted with attention to the needs of postpartum women's sleep and implications for health care providers., Data Extraction: Literature was reviewed and organized into groups with similar characteristics., Data Synthesis: An integrative review of the literature summarized the current state of research related to sleep alterations in postpartum women., Conclusions: Postpartum women experience altered sleep patterns that may lead to sleep disturbances. The most common reasons for sleep disturbances are related to newborn sleep and feeding patterns. Although present, the relationships among sleep disturbance, fatigue, and depression in postpartum women lack clarity due to their ambiguous definitions and the variety of the studies conducted. Providers should encourage prenatal education that assists the couple in developing strategies for decreasing postpartum sleep deprivation. Alterations of in-hospital care and home care should be incorporated to improve the new family's sleep patterns.

Objectives: Using patient and expert provider input, we previously developed a 15-item index of the most important symptoms and concerns of people being treated for advanced kidney cancer, the Functional Assessment of Cancer Therapy - Kidney Symptom Index (FKSI). These 15 concerns are a mixture of disease-related symptoms and treatment-related side effects. As a result, it may be difficult to assign an informative label to the score defined as the summation of these 15 most important concerns. Because one of the primary goals of treating advanced kidney cancer is the relief of disease-related symptoms, we set out to differentiate from the list of 15 symptoms those that are predominantly attributable to kidney cancer itself rather than its treatment, and to evaluate this abbreviated FKSI - Disease-Related Symptoms (FKSI-DRS)., Methods: Survey results from 18 experienced clinical experts were summarized to separate DRS from other concerns more arguably attributable to treatment side effects. This nine-item FKSI-DRS was then validated on a sample of 141 people with kidney cancer., Results: The FKSI-DRS is reliable (internal consistency range = 0.75-0.78; test-retest reliability intraclass correlation = 0.85), and valid, separating groups by performance status and the patient's own global rating of change. The likely minimally important difference in the FKSI-DRS is in the range of 2-3 points., Conclusions: The FKSI-DRS is a reliable, valid, and responsive brief index of the most important symptoms associated with advanced kidney cancer.

Objective: To determine distribution- and anchor-based minimal important difference (MID) estimates for four scores from the Functional Assessment of Cancer Therapy-Breast (FACT-B): the breast cancer subscale (BCS), Trial Outcome Index (TOI), FACT-G (the general version), and FACT-B., Study Design and Setting: We used data from a Phase III clinical trial in metastatic breast cancer (ECOG study 1193; n=739) and a prospective observational study of pain in metastatic breast cancer (n=129). One third and one half of the standard deviation and 1 standard error of measurement were used as distribution-based criteria. Clinical indicators used to determine anchor-based differences included ECOG performance status, current pain, and response to treatment., Results: FACT-B scores were responsive to performance status and pain anchors, but not to treatment response. By combining the results of distribution- and anchor-based methods, MID estimates were obtained: BCS=2-3 points, TOI=5-6 points, FACT-G=5-6 points, and FACT-B=7-8 points., Conclusion: Distribution- and anchor-based estimates of the MID do show convergence. These estimates can be used in combination with other measures of efficacy to determine meaningful benefit and provide a basis for sample size estimation in clinical trials.

This study's aim was to develop and validate a symptom index derived from the Functional Assessment of Cancer Therapy-Hepatobiliary, a questionnaire measuring general and hepatobiliary disease specific aspects of quality of life. The item pool was narrowed to 26 questions that assess symptoms and function. Each of 95 hepatobiliary cancer experts narrowed the list to 5 of the most important to attend to when treating advanced hepatobiliary disease. Eight symptoms were endorsed by more than 20% of the experts (3 pain, 2 fatigue, nausea, weight loss, jaundice) and were named the FACT-Hepatobiliary Symptom Index-8 (FHSI-8). Among 51 hepatobiliary cancer patients, the FHSI-8 showed good internal consistency (0.79), test-retest reliability (r = 0.86), strong association with mood (r = -0.56), and patient differentiation by ECOG Performance Status Rating ( P < 0.0001) and treatment status ( P = 0.057). Symptom scaling in diseases such as hepatobiliary cancer is feasible and may provide an efficient, clinically-relevant endpoint for following groups over time.