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Karen Kaiser,1 Susan E Yount,1 Christa E Martens,1 Kimberly A Webster,1 Sara Shaunfield,1 Amy Sparling,1 John Devin Peipert,1 David Cella,1 Scott T Rottinghaus,2 Bonnie MK Donato,2 Richard Wells,3 Ioannis Tomazos2 1Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; 2Alexion Pharmaceuticals Inc, Boston, MA, USA; 3Sunnybrook Health Sciences Centre, Toronto, ON, CanadaCorrespondence: Karen KaiserDepartment of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 625 N. Michigan Ave. Suite 2700, Chicago, IL 60611, USATel +1 312-503-3521Fax +1 312-503-4800Email k-kaiser@northwestern.eduPurpose: To develop a patient preference questionnaire (PPQ) assessing eculizumab and ravulizumab treatment for paroxysmal nocturnal hemoglobinuria (PNH).Patients and Methods: The development of the PNH-PPQ© was consistent with Food and Drug Administration guidelines for patient-reported outcome measure development, and included 1) a targeted literature review; 2) PNH expert clinician input on treatment preferences; 3) review of existing qualitative data on the PNH treatment and disease experience; 4) concept elicitation interviews with 8 PNH patients who received eculizumab and/or ravulizumab; 5) translatability review; and 6) cognitive debriefing with 5 patients. Interview participants were recruited through a United Kingdom PNH patient advocacy group and a Canadian clinical site involved in clinical trial ALXN1210-PNH-302.Results: Six themes were identified as most relevant to the PNH treatment experience from the concept elicitation interviews: disease symptoms (n=8/8); treatment frequency (n=7/8); quality of life impact of treatment/disease (n=7/8); treatment burden (n=7/8); treatment efficacy (n=5/8); and treatment side effects (n=5/8). An initial list of 88 preference questions was reduced to 11 highly relevant and non-redundant questions reflecting the 6 themes. Cognitive interview participants unanimously agreed that the PNH-PPQ instructions were clear; response options were understandable, easy to use, and provided enough choices; and the questions captured the factors that inform treatment preferences.Discussion: When new drugs have similar efficacy to existing medications, documenting patient preferences is important for confirming patient benefit from the new medication. Understanding what matters most to patients is essential for delivering patient-centered care and may play a particularly significant role in treatment decision making. The availability of such a tool may be especially important as new orphan drugs are developed and patients with rare diseases have more than one treatment option to consider.Conclusion: The PNH-PPQ provides a patient-centered approach for evaluating preferences for the treatment of PNH. The PNH-PPQ has subsequently assessed patient preference in the clinical trial sub-study ALXN1210-PNH-302s.Keywords: paroxysmal nocturnal hemoglobinuria, questionnaire development, ravulizumab, eculizumab, treatment experience

Purpose: The Patient-Reported Outcomes Measurement Information System (PROMIS®) initiative was developed to advance the methodology of PROs applicable to chronic diseases. Chronic obstructive pulmonary disease (COPD) is a progressive chronic disease associated with poor health. This study was designed to examine the correlation of PROMIS health-related quality of life (HRQOL) scales and clinical measures among COPD patients. Methods: A cross-sectional analysis was conducted comparing patients who were stable (n = 100) with those currently experiencing a COPD exacerbation (n = 85). All PROMIS measures for adults available at the time of the study (2008), disease-targeted and other HRQOL instruments, health literacy, percent predicted FEV1, and a 6-min walk distance were assessed when patients were considered clinically stable. Results: Stable COPD patients reported significantly (p ≤ 0.05) better health-related quality of life on PROMIS domains than patients experiencing an exacerbation. PROMIS domain scores were significantly (p ≤ 0.01) correlated with each of legacy measures. Six-min walk scores were most highly correlated with the PROMIS physical function domain scores (r = 0.53) followed by the fatigue (r = −0.26), social (r = 0.24) and to a lesser extent depression (r = −0.23), and anxiety (r = −0.22) domain scores. Percent predicted FEV1 score was significantly associated with PROMIS physical function scores (r = 0.27). Conclusion: This study provides support for the validity of the PROMIS measures in COPD patients.

Aims: Heart failure (HF) is a common and morbid condition impacting multiple health domains. We previously reported the development of the PROMIS®-Plus-HF (PROMIS+HF) profile measure, including universal and HF-specific items. To facilitate use, we developed shorter, PROMIS+HF profiles intended for research and clinical use., Methods and Results: Candidate items were selected based on psychometric properties and symptom range coverage. HF clinicians (n = 43) rated item importance and clinical actionability. Based on these results, we developed the PROMIS+HF-27 and PROMIS+HF-10 profiles with summary scores (0-100) for overall, physical, mental, and social health. In a cross-sectional sample (n = 600), we measured internal consistency reliability (Cronbach's alpha and Spearman-Brown), test-retest reliability (intraclass coefficient; n = 100), known-groups validity via New York Heart Association (NYHA) class, and convergent validity with Kansas City Cardiomyopathy Questionnaire (KCCQ) scores. In a longitudinal sample (n = 75), we evaluated responsiveness of baseline/follow-up scores by calculating mean differences and Cohen's d and comparing with paired t-tests. Internal consistency was good to excellent (α 0.82-0.94) for all PROMIS+HF-27 scores and acceptable to good (α/Spearman-Brown 0.60-0.85) for PROMIS+HF-10 scores. Test-retest intraclass coefficients were acceptable to excellent (0.75-0.97). Both profiles demonstrated known-groups validity for the overall and physical health summary scores based on NYHA class, and convergent validity for nearly all scores compared with KCCQ scores. In the longitudinal sample, we demonstrated responsiveness for PROMIS+HF-27 and PROMIS+HF-10 overall and physical summary scores. For the PROMIS+HF overall summary scores, a group-based increase of 7.6-8.3 points represented a small to medium change (Cohen's d = 0.40-0.42). For the PROMIS+HF physical summary scores, a group-based increase of 5.0-5.9 points represented a small to medium change (Cohen's d = 0.29-0.35)., Conclusions: The PROMIS+HF-27 and PROMIS+HF-10 profiles demonstrated good psychometric characteristics with evidence of responsiveness for overall and physical health. These new measures can facilitate patient-centred research and clinical care, such as improving care quality through symptom monitoring, facilitating shared decision-making, evaluating quality of care, assessing new interventions, and monitoring during the initiation and titration of guideline-directed medical therapy., (© 2022 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background and Aims: Patients with recurrent and/or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) experience vast disease and treatment burdens. Brief, focused instruments are needed to assess patient-reported priority symptoms and concerns as targeted outcome assessments for use in clinical research. Although the instrument was developed based on expert and patient input and is psychometrically valid, the Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Head and Neck Symptom Index-10 (FHNSI-10) has yet to undergo content validation from the perspective of R/M SCCHN patients to evaluate its use as a brief symptom-focused targeted endpoint assessment for use in clinical research., Methods: Interviews conducted with R/M SCCHN patients explored priority symptoms and concerns, followed by cognitive debriefing of the FHNSI-10 to evaluate face validity. Transcripts were analyzed, and results were mapped to the FHNSI-10. In accordance with published recommendations, expert input from the original development and published literature was considered for content validity assessment., Results: A total of 18 patients participated in a concept elicitation interview; saturation was obtained at interview 17. Most (83%) were undergoing active treatment, male (94%), white (72%), and did not have a college degree (67%). The most commonly mentioned symptoms were lumps/swelling, pain, sore throat, difficulty swallowing, and voice changes. For all items, ≥75% reported each question was relevant to their R/M SCCHN experience and 94% reported the instrument captured their experiences with R/M SCCHN., Conclusion: Results provide support for the content validity of the FHNSI-10, inasmuch as all 10 items were spontaneously reported and considered relevant to R/M SCCHN. Content validity might be enhanced by adding cough and hearing impairment items; however, the existing FHNSI-10 covers the majority of symptoms uncovered in interviews with a small sample of R/M SCCHN patients., Competing Interests: Authors Shaunfield, Yount, Boyken, and Cella received research funding from Daiichi Sankyo. Agulnik serves as a consultant for the following companies: Eisai, Inc., Eli Lilly and Company, Novartis, and Janssen Pharmaceuticals Inc.; Samant has investment interest in Y‐Trap Inc.; Cella is the President of FACIT.org and serves as a consultant to Pfizer, Novartis, and AbbVie Inc., (© 2021 The Authors. Health Science Reports published by Wiley Periodicals LLC.)

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.)

Objective: To develop a symptom-focused index to evaluate representative symptoms, treatment side effects, and emotional and functional well-being of patients with carcinoid syndrome (CS)., Methods: The development of the Functional Assessment of Cancer Therapy-Carcinoid Syndrome Symptom Index (FACT-CSI) followed US Food and Drug Administration guidelines for the development of patient-reported outcome (PRO) measures and involved the following: (a) literature review; (b) interviews with 14 CS patients; (c) interviews with 9 clinicians; and (d) instrument development involving input from a range of PRO measure development and CS experts. The resulting draft instrument underwent cognitive interviews with 7 CS patients., Results: Forty-six CS sources were reviewed. Analysis of patient interviews produced 23 patient-reported symptoms. The most frequently endorsed physical symptoms were flushing, diarrhea, abdominal pain, fatigue, and food sensitivity/triggers. Seven priority CS emotional and functional themes were also identified by patients. Expert interviews revealed 12 unique priority symptoms - the most common being diarrhea, flushing, wheezing, edema, abdominal pain/cramping, fatigue, and 8 emotional and functional concerns. Through an iterative process of team and clinical collaborator meetings, data review, item reduction and measure revision, 24 items were selected for the draft symptom index representing symptoms, emotional concerns, global assessment of treatment side effects, and functional well-being. Cognitive interview results demonstrated strong content validity, including positive endorsement of item clarity (>86% across items), symptom relevance (>70% for most items), and overall measure content (86%)., Conclusions: The FACT-CSI is a content-relevant, symptom-focused index reflecting the highest priority and clinically relevant symptoms and concerns of people with CS., (© 2020 S. Karger AG, Basel.)

Background: The objective of this study was to validate the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) in patients with acute myeloid leukemia (AML) who are not candidates for intensive therapy., Methods: A sample of 317 patients with AML who were not eligible for intensive chemotherapy completed the FACT-Leu and EuroQol 5-Dimension (EQ-5D) measures (Utility Index and Visual Analogue Scale) every 28 days until the end of treatment. Internal consistency reliability was estimated with Cronbach's α. Concurrent validity was examined with correlations between FACT-Leu and EQ-5D scales, and known-groups validity was examined by determining whether FACT-Leu scales distinguished between Eastern Cooperative Oncology Group (ECOG) performance status ratings (PSRs) and between maximum adverse event toxicities at the baseline. This study examined responsiveness to change by anchoring change in the FACT-Leu scales to a 0.10 change in the EQ-5D Health Utility Index., Results: Cronbach's α usually exceeded the threshold for good (≥0.80) or excellent reliability (≥0.90). Correlations between FACT-Leu and EQ-5D scales were moderate (r > 0.50) or high (r > 0.70). FACT-Leu scales distinguished between ECOG PSR groups with large effect sizes for an ECOG PSR of 0 versus an ECOG PSR of 2 (0.50 ≤ d < 0.80). In addition, Functional Assessment of Cancer Therapy-General, Additional Concerns, FACT-Leu Total, and Trial Outcomes Index scales distinguished between patients with grade 3 or lower maximum adverse event toxicities and those with maximum adverse event toxicities higher than grade 3, but effect sizes were small (d < 0.50). Finally, FACT-Leu scale coefficients for a 0.10 change in the 5-level version of the EQ-5D HUI ranged between -0.01 and 4.30., Conclusions: The FACT-Leu is a suitable outcome measure for AML clinical trials among patients not eligible for intensive therapy, and it may have value for clinical monitoring., (© 2020 American Cancer Society.)

Background: Survivors of cancer in the United States are often financially encumbered by expenses and lost wages from cancer treatment. The majority of patients with thyroid cancer are diagnosed before age 65, when they are not eligible for Medicare. We hypothesized that financial distress would be common among thyroid cancer survivors and would be associated with poor health-related quality of life., Methods: A financial distress questionnaire and Patient-Reported Outcomes Measurement Information System (29-item) were completed online by 1,743 adult thyroid cancer survivors living in the United States. Multivariable modeling was used to identify variables which independently predicted poor health-related quality of life. The magnitude of predicted change was estimated by β coefficients and 95% confidence intervals. A β ≥3 was considered clinically significant; α was set at 0.01., Results: Financial difficulties were reported by 43% of thyroid cancer survivors and were associated with worse anxiety (β = 5.07; P < .01) and depression (β = 5.47; P < .01). Living in poverty was associated with worse anxiety (β = 4.14; P < .01) and depression (β = 4.35; P < .01). Lost productivity at work was associated with worse fatigue (β = 5.99; P < .01) and social functioning (β = -4.07; P < .01). Inability to change jobs was associated with worse fatigue (β = 3.08; P < .01), pain interference (β = 3.56; P < .01), and social functioning (β = -3.09; P < .01). Receiving disability benefits was associated with worse pain interference (β = 3.93; P < .01). Impaired ability to obtain a job was associated with worse social functioning (β = -3.02; P < .01). Reported unemployment rate was 12.3%., Conclusion: Financial distress and negative financial events were common among thyroid cancer survivors and were associated with poorer health-related quality of life across 5 Patient-Reported Outcomes Measurement Information System health domains., (Copyright © 2019. Published by Elsevier Inc.)

Purpose: Patient-Reported Outcomes Measurement Information System ® (PROMIS ® ) physical function, cognitive function, and sleep disturbance measures are increasingly used in cancer care. However, there is limited guidance for interpreting the clinical meaning of scores. This study aimed to apply bookmarking, a standard setting methodology, to identify PROMIS score thresholds in the context of cancer care., Methods: Using item parameters, we constructed vignettes of five items covering the range of possible scores. Focus groups were held with cancer care providers and people with cancer. Terminology for categorizing levels of severity was explored. Participants rank ordered vignettes by severity and then placed bookmarks between vignettes representing different levels of severity. Group discussion was held until consensus on bookmark placement was reached., Results: Clinicians selected "within normal limits," "mild," "moderate," and "severe" to describe levels of severity. Both patients and clinicians were able to apply these labels, but there was not unanimous support for any set of descriptors. Clinicians and patients agreed on all severity thresholds for sleep disturbance. For cognitive and physical function, clinicians and patients agreed on the threshold between "within normal limits" and "mild." However, patients required greater dysfunction than clinicians before applying "moderate" and "severe" labels., Conclusions: Bookmarking can be applied to develop provisional score interpretation for PROMIS measures. Patients and clinicians were frequently consistent in their bookmark placement. When there was variance, patients required more dysfunction before assigning more severity. Additional research with other cancer samples is needed to evaluate the replicability and generalizability of our findings.

Background: Chronic obstructive pulmonary disease (COPD) is a progressive chronic disease characterized by airflow obstruction that leads to shortness of breath and substantial negative impacts on health-related quality of life (HRQL). The course of COPD includes periodic acute exacerbations that require changes in treatment and/or hospitalizations. This study was designed to examine the responsiveness of Patient-Reported Outcomes Measurement Information System® (PROMIS®) measures to changes associated with COPD exacerbation recovery., Methods: A longitudinal analysis using mixed-effects models was conducted of people who were enrolled while stable (n = 100) and those who experienced an acute exacerbation (n = 85). PROMIS (physical function, pain interference, pain behavior, fatigue, anxiety, depression, anger, social roles, discretionary social activities, Global Health, dyspnea severity and dyspnea functional limitations) and COPD-targeted HRQL measures were completed at baseline and at 12 weeks., Results: We administered PROMIS measures using computer adaptive testing (CAT), followed by administration of any remaining short form (SF) items that had not yet been administered by CAT. Examination of the difference between group differences from baseline to 12 weeks in the stable and exacerbation groups revealed that the exacerbation group changed (improved) significantly more than the stable group in anxiety (p < .001 to p < .01; f 2 effect size [ES] = 0.023/0.021), fatigue (p < .0001; ES = 0.036/0.047) and social roles (p < .001 to p < .05; ES = 0.035/0.024). All effect sizes were small in magnitude and smaller than hypothesized. Depression was also statistically significant (p < .05, SF only) but the ES was trivial. For all other PROMIS domains, the differences were not significant and ES were trivial., Conclusions: This longitudinal study provides some support for the validity of the PROMIS fatigue, anxiety, and social roles domains in COPD, but further evaluation of responsiveness is warranted.

Introduction: Thyroid cancer survivors are a rapidly growing population in the United States. The factors that drive health-related quality of life (HRQOL) in this population have not been well characterized. We hypothesized that more aggressive treatments and greater treatment-related adverse effects would be associated with worse HRQOL scores in thyroid cancer survivors., Methods: Thyroid cancer survivors (18-89 years of age) completed an online survey regarding their clinical history in addition to the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 instrument. Univariable and multivariable modeling were performed to evaluate factors associated with worse HRQOL scores. We generated β-values and 95% confidence intervals to quantify the effect of each independent variable in the model., Results: Thyroid cancer survivors (n = 1,743) reported a high incidence of complications related to surgery and radioactive iodine ablation. Postoperative dysphonia (ß 1.83-3.07) and dysphagia (ß 2.05-3.65) predicted worse HRQOL scores across multiple PROMIS domains. Younger patient age (age <45 years) and short- or long-term complications of radioactive iodine, including gastrointestinal symptoms (51.9%), appetite changes (71.2%), sialadenitis (58.1%), xerostomia (73.3%), and xerophthalmia (45.1%) were associated with worse HRQOL scores (P < .01)., Conclusion: The factors associated with significantly worse HRQOL scores across multiple PROMIS domains for thyroid cancer survivors included patient age <45 years, postoperative hypocalcemia, dysphonia, dysphagia, scar appearance, and complications from radioactive iodine. Methods of evaluation, management, and prevention of these factors might positively impact HRQOL., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: There is a paucity of patient-reported data on thyroidectomy scar perception. The effect of neck scarring on quality of life is not known. We hypothesized that worse perception of neck appearance would be related to worse health-related quality of life and that perception improves with time., Methods: Survivors of thyroid cancer (n = 1,710) were surveyed online. Respondents were asked to score the appearance of their neck via a 5-point Likert scale. Quality of life was evaluated via the Patient-Reported Outcomes Measurement Information System 29. The relationships between neck appearance, patient characteristics, quality of life, and Patient-Reported Outcomes Measurement Information System domains were analyzed with multivariable models and Spearman partial correlations (r s )., Results: Older age was associated with better perception of neck appearance (odds ratio 0.975/year; 95% confidence interval 0.967-0.983; P < .001). Greater time since surgery was also associated with improved perception (odds ratio 0.962/year; 95% confidence interval 0.947-0.977; P < .0001). We observed no statistically significant difference between current and preoperative baseline perception >2 years after surgery. On multivariable analysis, age >45 years, >2 years since surgery, and higher self-reported quality of life were independent predictors of better self-reported neck appearance (P ≤ .0003). In patients ≤2 years after surgery (n = 568), the PROMIS domains of anxiety, depression, social function, and fatigue had weak but statistically significant correlations with worse perception of neck appearance (P < .0001)., Conclusion: Age >45, >2 years since surgery, and higher quality of life were independently associated with better self-reported neck appearance. Perception of neck appearance returned to preoperative baseline 2 years after surgery. PROMIS domains had a weak but significant association with neck appearance perception in patients ≤2 years after surgery. The impact of post-thyroidectomy neck appearance on quality of life appears to be mild and transient and returns to preoperative levels after 2 years., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background Bringing together generic and heart failure (HF)-specific items in a publicly available, patient-reported outcome measure may facilitate routine health status assessment for improving clinical care and shared decision-making, assessing quality of care, evaluating new interventions, and comparing groups with different conditions. Methods and Results We performed a mixed-methods study to develop and validate the PROMIS®-Plus-HF (Patient-Reported Outcomes Measurement Information System®-Plus-Heart Failure) profile measure-a HF-specific instrument based on the generic PROMIS. We conducted 8 focus groups with 61 patients with HF and phone interviews with 10 HF clinicians. The measure was developed via an iterative process of reviewing existing PROMIS items and developing and testing new HF items. In a 600-patient sample, we estimated reliability (internal consistency; test-retest, with n=100 participants). We conducted validity analyses using Pearson r and Spearman ρ correlations with Kansas City Cardiomyopathy Questionnaire subscores. In a longitudinal sample, we performed responsiveness testing (paired t tests) with 75 patients with HF receiving interventions with expected health status improvement. The PROMIS-Plus-HF measure comprises 86 items (64 existing; 22 new) across 18 domains. Internal consistency reliability (Cronbach α) coefficients ranged from 0.52 to 0.96, with α≥0.70 in 12 of 17 domains. Test-retest intraclass correlation coefficients were ≥0.90. Correlations with Kansas City Cardiomyopathy Questionnaire subscores supported expected convergent ( r/ρ>0.60) and divergent validity ( r/ρ<0.30). In the longitudinal sample, 10 of 18 domains had improved ( P<0.05) scores from baseline to follow-up. Conclusions The PROMIS-Plus-HF profile measure-a complete assessment of physical, mental, and social health-exhibited good psychometric characteristics and may facilitate patient-centered care and research. Subsets of domains and items can be used depending on the clinical or research purpose.

The Patient-Reported Outcomes Measurement Information System® (PROMIS®) is a collection of person-centered measures of physical, mental, and social health in children and adults. Developed using state-of-the-art psychometric methods, these measures are offered as fixed-length questionnaires and computerized adaptive tests, with translations available in Spanish and other languages. This special issue presents articles that illustrate the use of PROMIS® measures to advance health behavior research across a wide range of health studies. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Introduction: Chronic obstructive pulmonary disease (COPD) is a tobacco-related disease associated with several comorbid conditions, including elevated rates of depression and anxiety. Psychological factors that commonly underlie nicotine dependence, depression, and anxiety may represent novel treatment targets, but have not yet been examined among patientswith COPD. We assessed three psychological factors-anxiety sensitivity (AS; fear of anxiety-related sensations), distress intolerance (DI; inability to withstand distressing states), and anhedonia (Anh; diminished sense of pleasure or interest)-in relation to smoking status, COPD symptom impact, and negative response to COPD symptoms., Methods: We conducted a single-session laboratory assessment with 37 patients with COPD (17 current daily smokers and 20 former smokers). All participants completed self-report measures of psychological factors, COPD symptom impact, response to COPD symptoms, and anxiety and depression symptoms., Results: Current versus former smokers with COPD reported higher levels of AS, DI, and Anh. In univariate regression models, AS, DI, and Anh were each associated with greater COPD symptom impact and breathlessness catastrophizing. Only AS remained a significant predictor of COPD symptom impact and breathlessness catastrophizing after adjusting for general depression and anxiety symptoms., Conclusions: Our preliminary study is the first to assess AS, DI, and Anh among patients with COPD. These psychological factors were elevated among current smokers and associated with more negative disease impact, suggesting their potential utility as treatment targets within this clinical population., Implications: While elevated rates of anxiety and depression among patients with COPD have been wellcharacterized, few studies have specifically addressed the causal, modifiable psychological factors that may underlie these disorders. Our preliminary findings demonstrate associations of three psychological factors-AS, DI, and Anh-with smoking status, COPD symptom impact, and negative reaction to symptoms. Cognitive-behavioral interventions targeted to these psychological factors may improve smoking cessation outcomes and disease adjustment among patients with COPD., (© The Author(s) 2018. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Thyroid cancer survivors may experience long-lasting physical, psychosocial, and financial challenges. No previous studies have compared health-related quality of life in thyroid cancer survivors to United States normative data and patient-reported outcomes from other types of cancers. We hypothesized that thyroid cancer survivors would report health-related quality of life poorer than the general United States population but similar to individuals with other cancers., Methods: Thyroid cancer survivors were recruited online January2017-June 2017. Individuals completed a two-part questionnaire to assess clinical characteristics and health-related quality of life, using the Patient-Reported Outcomes Measurement Information System 29-item profile. Patient-Reported Outcomes Measurement Information System T-scores obtained from the literature were compared with United States normative data and T-scores from patients with breast, prostate, uterine, cervical, colorectal, non-Hodgkin lymphoma, and lung cancers., Results: A total of 1,743 US respondents completed the survey. Thyroid cancer survivors reported statistically significantly worse health-related quality of life across all seven Patient-Reported Outcomes Measurement Information System domains compared with United States normative data (P < .05). Surveyed individuals reported statistically significantly worse scores for anxiety, depression, fatigue, and sleep disturbance than respondents from non-Hodgkin lymphoma, breast, colorectal, uterine, and prostate cancer cohorts (P < .01) but less pain and greater physical functioning than most other groups in this comparison (P < .01)., Conclusion: The importance of health-related quality of life among thyroid cancer survivors should not be obscured by the relatively high survival rate of thyroid cancer compared with other cancers. Our results demonstrate that thyroid cancer survivors may be encumbered with greater psychologic and social burdens than survivors of several cancers that have a worse prognosis., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Background: Patient-reported outcomes are measured in chronic disease states to inform intervention and management decisions while minimizing negative outcomes. We hypothesized that health-related quality of life in patients with multiple endocrine neoplasia type 2A would be worse than the general US population but similar to other chronic diseases., Methods: Adults ≥18 years with multiple endocrine neoplasia type 2A were recruited to complete the Patient-Reported Outcomes Measurement Information System 29-item questionnaire (n = 45). Scores based on the Patient-Reported Outcomes Measurement Information System T-score metric were compared with the general US population and with cohorts with low back pain, cancer, congestive heart failure, chronic obstructive pulmonary disease, major depressive disorder, rheumatoid arthritis, neuroendocrine tumors, primary hyperparathyroidism, and MEN1., Results: Compared with US normative data, multiple endocrine neoplasia type 2A patients reported worse anxiety (58.2 ± 12.0, P < .0001), depression (55.4 ± 12.0, P < .01), fatigue (61.4 ± 10.8, P < .0001), pain interference (54.0 ± 11.5, P < .05), and sleep disturbance (56.9 ± 2.7, P < .001), as well as significantly lower physical functioning (45.7 ± 9.3, P < .01) and ability to participate in social roles (46.4 ± 9.7, P < .05). Multiple endocrine neoplasia type 2A patients reported greater fatigue than patients with cancer (P < .0001), chronic obstructive pulmonary disease (P = .01), rheumatoid arthritis (P = .0002), neuroendocrine tumors (P = .0007), and primary hyperparathyroidism (P < .0001) but higher physical functioning compared with patients with rheumatoid arthritis (P = .02), low back pain, congestive heart failure, and chronic obstructive pulmonary disease (P < .0001)., Conclusions: This study is the first to use the Patient-Reported Outcomes Measurement Information System to compare patient-reported outcomes between multiple endocrine neoplasia type 2A and other chronic conditions. Individuals with multiple endocrine neoplasia type 2A reported worse health-related quality of life in all 7 domains compared with US normative data. Multiple endocrine neoplasia type 2A patients reported greater fatigue but greater physical function compared with several other conditions. Prospective longitudinal evaluation of patient-reported outcomes in multiple endocrine neoplasia type 2A should be conducted to identify treatments associated with the highest health-related quality of life., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Purpose: Patient-reported outcome measures (PROMs), which are generic or condition-specific, are used for a number of reasons, including clinical care, clinical trials, and in national-level efforts to monitor the quality of health care delivery. Creating PROMs that meet different purposes without overburdening patients, healthcare systems, providers, and data systems is paramount. The objective of this study was to test a generalizable method to incorporate condition-specific issues into generic PROM measures as a first step to producing PROMs that efficiently provide a standardized score. This paper outlines the method and preliminary findings focused on a PROM for osteoarthritis of the knee (OA-K)., Methods: We used a mixed-methods approach and PROMIS ® measures to test development of a combined generic and OA-K-specific PROM. Qualitative methods included patient focus groups and provider interviews to identify impacts of OA-K important to patients. We then conducted a thematic analysis and an item gap analysis: identified areas covered by existing generic PROMIS measures, identified "gap" areas not covered, compared gap areas to legacy instruments to verify relevance, and developed new items to address gaps. We then performed cognitive testing on new items and drafted an OA-K-specific instrument based on findings., Results: We identified 52 existing PROMIS items and developed 24 new items across 14 domains., Conclusions: We developed a process for creating condition-specific instruments that bridge gaps in existing generic measures. If successful, the methodology will create instruments that efficiently gather the patient's perspective while allowing health systems, researchers, and other interested parties to monitor and compare outcomes over time, conditions, and populations.

Background: Health-related quality of life (HRQOL) in multiple endocrine neoplasia type-1 (MEN-1) is poorly described. HRQOL in MEN-1 was compared with other chronic conditions and the US general population., Methods: Adults aged ≥18 years recruited from an MEN-1 support group (n=153) completed the Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item profile. MEN-1 scores were compared with PROMIS scores reported in peer-reviewed literature from back pain (n=218), cancer (n=310), congestive heart failure (CHF; n=60), chronic obstructive pulmonary disease (COPD; n=79), major depressive disorder (n=196), rheumatoid arthritis (RA; n=521), neuroendocrine tumors (NET; n=619), and primary hyperparathyroidism (PHPT; n=45) cohorts., Results: Patients with MEN-1 reported worse anxiety (mean=61.7), depression (57.9), fatigue (62.2), pain interference (55.4), sleep disturbance (58.0), physical functioning (44.4), and social functioning (44.7) compared to normative data (50, P < .05) and greater anxiety, depression, and fatigue than patients with back pain, cancer, COPD, RA, NETs, and PHPT (P < .001). MEN-1 respondents had greater pain interference (55.4) than those with cancer (51.9), NETs (52.3), and PHPT (38.4, P < .05). Physical functioning was higher in individuals with MEN-1 (44.4) than in those with back pain (37.5), CHF (34.8), COPD (38.0), and RA (40.7, P < .01)., Conclusion: This is the first study to describe HRQOL in a large sample of adults with MEN-1. MEN-1respondents reported worse HRQOL across PROMIS 29-item profile measure domains compared with the US general population and higher levels of anxiety, depression, and fatigue compared with many other chronic conditions., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Physical and psychosocial morbidity of multiple endocrine neoplasia type-1 is ill-defined. How disease and treatment-related factors relate to patient-reported outcomes including health-related quality of life is unknown. We hypothesized that disease and treatment burden negatively impacts health-related quality of life in adults with multiple endocrine neoplasia type-1., Methods: Adults (≥18 years) with multiple endocrine neoplasia type-1 completed an online survey of demographics, disease features, treatments, and Patient-Reported Outcomes Measurement Information System 29-item profile measure, and scores were compared with normative US data. Multivariable modeling was performed to evaluate factors associated with decreased health-related quality of life., Results: Multiple endocrine neoplasia type-1 patients (n = 207) reported worse health-related quality of life compared with US normative data in all health-related quality of life domains (P < .001). Persistent hypercalcemia after parathyroid surgery was associated with higher levels of anxiety, depression, fatigue, and decreased social functioning (P < .05). Patients <45 years of age at diagnosis reported worse physical and social functioning (P < .01). Traveling >50 miles for doctor appointments and ≥20 doctor appointments/year (P < .05) were associated with worse health-related quality of life. History of pancreatic neuroendocrine tumors was not associated with worse health-related quality of life., Conclusion: This is the largest study to assess clinical and treatment factors associated with health-related quality of life in multiple endocrine neoplasia type-1. Persistent hyperparathyroidism, increased travel distance and frequency of doctor appointments were all associated with worse health-related quality of life., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Health-related quality of life and financial burden among patients with multiple endocrine neoplasia type 1 is poorly described. It is not known how financial burden influences health-related quality of life in this population. We hypothesized that the financial burden attributable to multiple endocrine neoplasia type 1 is associated with worse health-related quality of life., Methods: United States adults (≥18 years) with multiple endocrine neoplasia type 1 were recruited from the AMENSupport MEN online support group. Patient demographics, clinical characteristics, and financial burden were assessed via an online survey. The instrument Patient-Reported Outcomes Measurement Information System 29-item profile measure was used to assess health-related quality of life. Multivariable linear regression was used to identify significant variables in each Patient-Reported Outcomes Measurement Information System domain., Results: Out of 1,378 members in AMENSupport, our survey link was accessed 449 times (33%). Of 153 US respondents who completed our survey, 84% reported financial burden attributable to multiple endocrine neoplasia type 1. The degree of financial burden had a linear relationship with worse health-related quality of life across all Patient-Reported Outcomes Measurement Information System domains (r = 0.36-0.55, P < .001); 63% reported experiencing ≥1 negative financial event(s). Borrowing money from friends/family (30%), unemployment (13%), and spending >$100/month out-of-pocket on prescription medications (46%) were associated consistently with impaired health-related quality of life (ß = 3.75-6.77, P < .05). Respondents were 3- and 34-times more likely to be unemployed and declare bankruptcy than the US population, respectively., Conclusion: This study characterizes the financial burden in patients with multiple endocrine neoplasia type 1. Individuals with multiple endocrine neoplasia type 1 report a high degree of financial burden, negative financial events, and unemployment. Each of these factors was associated with worse health-related quality of life., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Purpose: Idiopathic pulmonary fibrosis (IPF) produces symptoms and activity limitations that impair health-related quality of life (HRQOL). The Patient-Reported Outcomes Measurement Information System(®) (PROMIS(®)) includes measures of self-reported health and HRQOL for a range of conditions. This study evaluated the HRQOL of individuals with IPF using PROMIS measures and examined associations between HRQOL and key symptoms or supplemental oxygen need., Methods: Individuals who reported being told by a doctor that they have IPF completed an online battery of measures at baseline and 7-10 days later (for test-retest reliability). Measures included a brief survey of demographic and health-related questions, the PROMIS-29 profile, the Modified Medical Research Council Dyspnea Scale (MMRC), PROMIS dyspnea severity short form, A Tool to Assess Quality of life in IPF (ATAQ-IPF) and one cough item from the Functional Assessment of Chronic Illness Therapy (FACIT)., Results: 220 individuals were included in the final sample. Except for sleep disturbance, all PROMIS domain scores significantly (p < .01) differed by MMRC level. Supplemental oxygen users were more impaired than non-users in fatigue, physical function, and social role participation (p < 0.01). The test-retest reliability was acceptable to excellent (>0.7) for all scales, but was lower for sleep disturbance (0.64)., Conclusions: People with IPF report substantial deficits in HRQOL across a range of PROMIS domains, and deficits vary by dyspnea and cough severity. These deficits warrant monitoring in clinical practice and consideration when investigating new therapies. Further research is required to further evaluate the psychometric performance of the PROMIS-29 in IPF.

The Functional Assessment of Cancer Therapy (FACT)-Antiangiogenesis (AntiA) Subscale was developed and validated to enhance treatment decision-making and side effect management for patients receiving anti-angiogenesis therapies. Side effects related to anti-angiogenesis therapies were identified from the literature, clinician input, and patient input. Fifty-nine possible patient expressions of side effects were generated. Patient and clinician ratings of the importance of these expressions led us to develop a 24-item questionnaire with clinical and research potential. To assess the scale's reliability and validity, 167 patients completed the AntiA Subscale, the Functional Assessment of Cancer Therapy-general (FACT-G), the FACT-Kidney Symptom Index (FKSI), the FACIT-Fatigue Subscale, the Global Rating of Change Scale (GRC), and the PROMIS Global Health Scale. Patient responses to the AntiA were analyzed for internal consistency, test-retest reliability, convergent and discriminant validity, and responsiveness to change in clinical status. All tested scales were found to have good internal consistency reliability (Cronbach's alpha 0.70-0.92). Test-retest reliability was also good (0.72-0.88) for total and subscale scores and lower for individual items. The total score, subscale scores, and all single items (except nosebleeds) significantly differentiated between groups defined by level of side effect bother. Evaluation of responsiveness to change in this study was not conclusive, suggesting an area for further research. The AntiA is a reliable and valid measure of side effects from anti-angiogenesis therapy., (© 2014 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Rationale: Patients with chronic obstructive pulmonary disease (COPD) have high symptom burdens and poor health-related quality of life. The American Thoracic Society issued a consensus statement outlining the need for palliative care for patients with chronic respiratory diseases. A better understanding of the unmet healthcare needs among patients with COPD may help determine which aspects of palliative care are most beneficial., Objectives: To identify the unmet healthcare needs of patients with COPD hospitalized for exacerbation using qualitative methods., Methods: We conducted 20 semistructured interviews of patients admitted for acute exacerbations of COPD focused on patient understanding of diagnosis and prognosis, effect of COPD on daily life and social relationships, symptoms, healthcare needs, and preparation for the end of life. Transcribed interviews were evaluated using thematic analysis., Measurements and Main Results: Six themes were identified. (1) Understanding of disease: Most participants correctly identified their diagnosis and recognized their symptoms worsening over time. Only half understood their disease severity and prognosis. (2) SYMPTOMS: Breathlessness was universal and severe. (3) Physical limitations: COPD prevented participation in activities. (4) Emotional distress: Depressive symptoms and/or anxiety were present in most participants. (5) Social isolation: Most participants identified social limitations and felt confined to their homes. (6) Concerns about the future: Half of participants expressed fear about their future., Conclusions: There are many unmet healthcare needs among patients hospitalized for COPD exacerbation. Relief of symptoms, physical limitations, emotional distress, social isolation, and concerns about the future may be better managed by integrating specialist palliative care into our current care model.

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: 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.)

Recent guidance from the FDA discusses patient-reported outcomes as end points in clinical trials. Using methods consistent with this guidance, the authors developed symptom indexes for patients with advanced cancer. Input on the most important symptoms was obtained from 533 patients recruited from NCCN Member Institutions and 4 nonprofit social service organizations. Diagnoses included bladder, brain, breast, colorectal, head and neck, hepatobiliary/pancreatic, kidney, lung, ovarian, and prostate cancers and lymphoma. Physician experts in each of these diseases were also surveyed to differentiate symptoms that were predominantly disease-based from those that were predominantly treatment-induced. Results are evaluated alongside previously published indexes for 9 of these 11 advanced cancers that were created based on expert provider surveys, also implemented at NCCN Member Institutions. Final results are 11 symptom indexes that reflect the highest priorities of people affected by these 11 advanced cancers and the experienced perspective of the people who provide their medical treatment. Beyond the clinical value of such indexes, they may also contribute significantly to satisfying regulatory requirements for a standardized tool to evaluate drug efficacy with respect to symptomatology.

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.)

We performed a systematic search of the literature using the MEDLINE (through 2006) database to identify the patient-reported outcome measures of quality of life (QOL) used most often in the renal transplant literature. After applying limits and reviewing references, we identified 338 renal transplant articles with a formal QOL assessment. Among the most frequently cited instruments were generic QOL tools, such as the Short Form-36, the Sickness Impact Profile, and the World Health Organization Quality of Life questionnaire. Other frequently cited instruments were more targeted in nature, such as the End-stage Renal Disease-Symptom Checklist and the Kidney Disease Quality of life questionnaire. In the present article, we review the most commonly used instruments, their use in renal transplant, and suggest future directions to improve QOL assessment in this population.

We tested the reliability and validity of a brief symptom index for use with patients in the advanced stages of lung cancer. The Functional Assessment of Cancer Therapy--Lung Symptom Index-12 (FLSI-12) is a brief self-report measure that combines seven items addressing symptoms common in advanced-stage lung cancer with five symptoms or concerns that are relevant to most people with advanced-stage cancer. The index was administered prospectively to 92 advanced-stage lung cancer patients beginning at the initiation of chemotherapy and for 12 consecutive weeks. Reliability, convergent and concurrent validities, and responsiveness to change were determined and a minimally important difference (MID) was estimated. The index had good internal consistency (all Cronbach's alpha's>0.70), moderate to high item-to-total correlations (93% rho's> or =0.30), and correlated highly with a measure of overall quality of life (rho's> or =0.50). Baseline scores differentiated patients with better versus worse clinical features (p's<.05). Prospective changes in index scores were sensitive to changes in performance status ratings (p's<.05). An MID of 3-4 points was estimated by combining guideline-, distribution-, and anchor-based methods. The results show that the FLSI-12 is a psychometrically sound measure and support its use as an endpoint in clinical trials of advanced-stage lung cancer.

We assessed the reliability, validity, and responsiveness to change of the 6-item Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI) in a sample of 615 metastatic breast cancer patients. The FBSI is a brief, clinically relevant, and psychometrically sound instrument that can be used to measure symptoms in patients with breast 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.

Purpose: To determine the ability of longitudinal patient-reported health (PRH) scores to enhance prediction of clinical outcomes beyond baseline scores., Patients and Methods: In 573 advanced non-small-cell lung cancer patients enrolled in a phase III clinical trial, we used baseline and 6-week follow-up PRH scores to predict best response to treatment, disease progression, and survival. Using regression analyses, we tested the predictive ability of the five subscales of the Functional Assessment of Cancer Therapy-Lung (physical, functional, social/family, emotional well-being, and the lung cancer subscale) as well as the trial outcome index (TOI) aggregate score., Results: After clinical factors were controlled for, baseline physical well-being (PWB) and TOI scores predicted all three clinical outcomes. A higher baseline PWB score was associated with a better response to treatment (odds ratio, 1.09; P <.001) and lower risk of death (risk ratio, 0.95; P <.001). Higher baseline TOI score was associated with a lower risk of disease progression (risk ratio, 0.98; P <.001). These two baseline predictors (PWB and TOI) were then used along with 6-week change scores to classify patients into four groups: low baseline-declined, low baseline-improved, high baseline-declined, and high baseline-improved. Patients with low baseline-declined PWB scores showed the worst responses to treatment and survived the shortest duration. Patients with low baseline-declined TOI scores had the shortest time to progression., Conclusion: The physical aspects of baseline PRH and PRH change during chemotherapy are significant predictors of clinical outcomes in lung cancer. This has implications for patient stratification in clinical trials and may aid decision-making in clinical practice.

The authors tested effects of a 10-week group cognitive-behavioral stress management intervention among 100 women newly treated for Stage 0-II breast cancer. The intervention reduced prevalence of moderate depression (which remained relatively stable in the control condition) but did not affect other measures of emotional distress. The intervention also increased participants' reports that having breast cancer had made positive contributions to their lives, and it increased generalized optimism. Both remained significantly elevated at a 3-month follow-up of the intervention. Further analysis revealed that the intervention had its greatest impact on these 2 variables among women who were lowest in optimism at baseline. Discussion centers on the importance of examining positive responses to traumatic events--growth, appreciation of life, shift in priorities, and positive affect-as well as negative responses.

Noncompliance to treatment regimen after kidney transplantation is a threat to health outcomes and cost containment. Although there are methodological challenges to obtaining reliable compliance data, the results of noncompliance are increased morbidity and mortality in posttransplant patients. In addition, recent research suggests that patients who incur repeated rejection episodes leading to graft failure have higher levels of medical utilization. Some psychosocial factors related to compliance and medical utilization are potentially modifiable through cognitive-behavioral intervention.

Stringent long-term control of blood glucose concentration in patients with insulin-dependent diabetes mellitus (IDDM) can decrease albuminuria, presumably forestalling development of renal insufficiency. Personality characteristics may influence a diabetic patient's ability and willingness to follow a prescribed regimen to achieve glycemic control. This study investigated the relationship of 2 personality factors to renal deterioration time (from initiation of insulin therapy to renal failure) in 85 patients with IDDM and end-stage renal disease. Persons moderate in the personality trait of neuroticism and high in conscientiousness had renal deterioration times that were 12 years longer than persons with either high or low neuroticism and low conscientiousness, presumably because of better self-care. The implications of this study's findings are discussed.

Memory-concentration complaints are a common symptom among end-stage renal disease patients receiving hemodialysis. However, assuming an organic basis for these complaints might lead to unnecessary and expensive testing. To further explore the etiology of cognitive complaints, this study examined the contribution of demographic, neuropsychological, medical, affective, and personality variables to memory-concentration complaints in 426 hemodialysis patients. Following stepwise multiple regression to identify the best predictor variables within each domain, hierarchical multiple-regression analysis determined the significant predictors of memory-concentration complaints. Education, digit symbol score, and hemoglobin jointly accounted for approximately 7% of the variance. Cognitive (psychological) symptoms of depression explained an additional 9% of variance. Somatic symptoms of depression did not significantly contribute, whereas state anxiety did. Finally, personality variables collectively accounted for another 9% of variance. Overall, the model accounted for 28% of explained variance in memory-concentration complaints. These findings demonstrate that affect and personality factors are more predictive of memory-concentration complaints in hemodialysis patients than are neuropsychological or medical factors. The clinical implication is that the initial response to memory-concentration complaints in these patients should be evaluations of psychological condition.

The ability of amphetamine to alter the extracellular level of ascorbate, an apparent modulator of neostriatal function, was assessed voltammetrically in the neostriatum and nucleus accumbens of awake, behaving rats. Whereas acute administration (1.0 and 5.0 mg/kg d-amphetamine) produced a dose-dependent rise in neostriatal ascorbate, there was no change in the nucleus accumbens. Vehicle injections had no significant effect on ascorbate levels in either location. Administration of 5.0 mg/kg d-amphetamine for one week enhanced neostriatal ascorbate release even further, but this effect returned to acute levels when treatment continued for a second week. Multiple amphetamine injections for up to two weeks failed to alter extracellular ascorbate in the nucleus accumbens. The results of these experiments confirm a site-specific action of amphetamine on ascorbate release and suggest complex changes in the extracellular level of this substance in the neostriatum with long-term treatment.