Positive and negative psychosocial impacts on cancer survivors.

The purpose of this study is to understand psychosocial impacts on cancer survivors using the patient-reported outcomes measurement information system (PROMIS) Psychosocial Illness Impact banks. Cancer survivors (n = 509; age: 59.5 ± 1.4; 51.5% men) completed the PROMIS positive and negative illness impact items consisting of four sub-domains: self-concept (SC), social impact (SI), stress response (SR), and spirituality (Sp). Illness impact was defined as changed scores from items measuring "current" experiences to recalled experiences prior to cancer diagnosis. Descriptive statistics, effect sizes (ES), and coefficient of variation (CV) were calculated at item and sub-domain levels. Analysis of variance was used to identify potentially influential factors on the impacts. Our study found survivors reported stronger positive than negative impacts (overall ES mean: 0.30 vs. 0.23) in general; and more moderate (ES ≧ 0.30) positive than negative impacts at the item level, 54.3% (25 of 46) and 40% (16 of 40) for positive and negative items, respectively. Participants reported more positive impacts on SI and Sp but more negative impacts on SR. The CV results showed more individual differences appeared on positive SC items. Younger survivors reported stronger positive and negative impacts. Women reported higher positive impacts. Survivors with higher education levels tended to have higher positive SI impacts, while those with a lower family income reported higher negative SI and negative SR impacts. We conclude positive and negative psychosocial impacts coexisted-the strength of impacts varied across sub-domains. Age, gender, education, and family income influenced the psychosocial impacts reported by survivors. These findings provide a foundation to develop interventions to strengthen positive and minimize negative impacts and improve cancer survivors' overall well-being.

Feasibility of PROMIS using computerized adaptive testing during inpatient rehabilitation.

BACKGROUND: There has been an increased significance on patient-reported outcomes in clinical settings. We aimed to evaluate the feasibility of administering patient-reported outcome measures by computerized adaptive testing (CAT) using a tablet computer with rehabilitation inpatients, assess workload demands on staff, and estimate the extent to which rehabilitation inpatients have elevated T-scores on six Patient Reported Outcomes Measurement Information System® (PROMIS®) measures. METHODS: Patients (N = 108) with stroke, spinal cord injury, traumatic brain injury, and other neurological disorders participated in this study. PROMIS computerized adaptive tests (CAT) were administered via a web-based platform. Summary scores were calculated for six measures: Pain Interference, Sleep Disruption, Anxiety, Depression, Illness Impact Positive, and Illness Impact Negative. We calculated the percent of patients with T-scores equivalent to 2 standard deviations or greater above the mean. RESULTS: During the first phase, we collected data from 19 of 49 patients; of the remainder, 61% were not available or had cognitive or expressive language impairments. In the second phase of the study, 40 of 59 patients participated to complete the assessment. The mean PROMIS T-scores were in the low 50 s, indicating an average symptom level, but 19-31% of patients had elevated T-scores where the patients needed clinical action. CONCLUSIONS: The study demonstrated that PROMIS assessment using a CAT administration during an inpatient rehabilitation setting is feasible with the presence of a research staff member to complete PROMIS assessment.

The development and initial validation of the PROMIS®+HF-27 and PROMIS+HF-10 profiles.

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.

Effects of patient-reported outcome assessment order.

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

Optimizing brief, focused assessment of priority symptoms and concerns in recurrent and/or metastatic squamous cell carcinoma of the head and neck: Content validation of the Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network Head and Neck Symptom Index-10 (FHNSI-10).

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.

The PROMISⓇ-Plus-Osteoarthritis of the Knee (OAK) profile measure integrates generic and condition-specific content to enhance relevance and efficiency.

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.

Development of the Functional Assessment of Cancer Therapy-Carcinoid Syndrome Symptom Index.

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.

Prenatal and Postpartum Experience, Knowledge and Engagement with Kegels: A Longitudinal, Prospective, Multisite Study.

Introduction: Urinary incontinence (UI) increases during pregnancy and continues into the postpartum period. Continued UI impacts women's comfort and affects aspects of their everyday lives. Kegel exercises have been found to decrease the incidence and severity of UI. The purpose of this study was to describe severity of UI, how women gained knowledge about Kegels, influences impacting Kegel exercises during pregnancy and postpartum, and characterize women's performance of Kegels. Methods: A longitudinal, prospective, multistate study was undertaken at four sites across the United States. Postpartum women completed the Pelvic Floor Control Questionnaire that incorporated the Sandvik Severity Index. At 3 and 6 months postpartum the women's UI, performance of Kegels, and affect on life was reviewed through seven questions. Institutional Review Board (IRB) approval was obtained. Results: Participants were 368 predominately multiparous, white women. Approximately 20% of women reported prepregnancy UI. Multiparous women reported similar incidence rate of UI regardless of birth history. Among one-fifth of the participants, persistent UI was reported as 45.2% at 3 months and 44.1% at 6 months postpartum. Only 25% of these women sought care. Women learned about Kegel exercises from written information or their provider. Women performed an average 16 Kegels twice daily. Kegel performance increased at 3 months postbirth but dropped by 6 months. UI was associated with age >35 and parity. Discussion: Prevalence of UI before and during pregnancy and postpartum is high, yet consistent Kegel performance postpartum is low. Screening for UI is necessary and high-quality referrals for treatment are needed. Consistent education is needed for all women. Education and support should be individualized. Future research is needed to identify techniques that motivate women to routinely perform Kegel exercises.

Patient preferences and quality of life implications of ravulizumab (every 8 weeks) and eculizumab (every 2 weeks) for the treatment of paroxysmal nocturnal hemoglobinuria.

BACKGROUND: Eculizumab has transformed management of paroxysmal nocturnal hemoglobinuria (PNH) since its approval. However, its biweekly dosing regimen remains a high treatment burden. Ravulizumab administered every 8 weeks demonstrated noninferiority to eculizumab in two phase 3 trials. In regions where two PNH treatment options are available, it is important to consider patient preference. OBJECTIVE: The aim of this study was to assess patient preference for ravulizumab or eculizumab. METHODS: Study 302s (ALXN1210-PNH-302s) enrolled PNH patients who participated in the extension period of phase 3 study ALXN1210-PNH-302. In the parent study, eculizumab-experienced adult PNH patients received ravulizumab or eculizumab during a 26-week primary evaluation period. All patients in the extension period received ravulizumab. In study 302s, patient treatment preference was evaluated using an 11-item PNH-specific Patient Preference Questionnaire (PNH-PPQ©). Of 98 patients, 95 completed PNH-PPQ© per protocol for analysis. RESULTS: Overall, 93% of patients preferred ravulizumab whereas 7% of patients either had no preference (6%) or preferred eculizumab (1%) (P < 0.001). For specific aspects of treatment, ravulizumab was preferred (in comparison to no preference or eculizumab) on infusion frequency (98% vs. 0% vs. 2%), ability to plan activities (98% vs. 0% vs. 2%), and overall quality of life (88% vs. 11% vs. 1%), among other aspects. Most participants selected frequency of infusions as the most important factor determining preference (43%), followed by overall quality of life (23%). CONCLUSION: This study shows that a substantial proportion of patients preferred ravulizumab over eculizumab and provides an important patient perspective on PNH treatment when there is more than one treatment option.

Validation of the Functional Assessment of Cancer Therapy-Leukemia instrument in patients with acute myeloid leukemia who are not candidates for intensive therapy.

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.

Assessing Preferences for Rare Disease Treatment: Qualitative Development of the Paroxysmal Nocturnal Hemoglobinuria Patient Preference Questionnaire (PNH-PPQ©).

PURPOSE: 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.

Financial burden and quality of life among thyroid cancer survivors.

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 ß coefficients and 95% confidence intervals. A ß ≥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 (ß = 5.07; P < .01) and depression (ß = 5.47; P < .01). Living in poverty was associated with worse anxiety (ß = 4.14; P < .01) and depression (ß = 4.35; P < .01). Lost productivity at work was associated with worse fatigue (ß = 5.99; P < .01) and social functioning (ß = -4.07; P < .01). Inability to change jobs was associated with worse fatigue (ß = 3.08; P < .01), pain interference (ß = 3.56; P < .01), and social functioning (ß = -3.09; P < .01). Receiving disability benefits was associated with worse pain interference (ß = 3.93; P < .01). Impaired ability to obtain a job was associated with worse social functioning (ß = -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.

Responsiveness of PROMIS® to change in chronic obstructive pulmonary disease.

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; f2 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.

Establishing clinically-relevant terms and severity thresholds for Patient-Reported Outcomes Measurement Information System® (PROMIS®) measures of physical function, cognitive function, and sleep disturbance in people with cancer using standard setting.

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.

Development and Initial Validation of the PROMIS®-Plus-HF Profile Measure.

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.

PROMIS® Adult Health Profiles: Efficient Short-Form Measures of Seven Health Domains.

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.

PROMIS®: Standardizing the patient voice in health psychology research and practice.

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).

Post-thyroidectomy neck appearance and impact on quality of life in thyroid cancer survivors.

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 (rs). 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.

Clinical factors associated with worse quality-of-life scores in United States thyroid cancer survivors.

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 ß-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.

Assessment of Self-Management Treatment Needs Among COPD Helpline Callers.

Telephone quitlines are an effective population-based strategy for smoking cessation, particularly among individuals with tobacco-related diseases such as chronic obstructive pulmonary disease (COPD). Expanding quitline services to provide COPD-focused self-management interventions is potentially beneficial; however, data are needed to identify specific treatment needs in this population. We conducted a telephone-based survey (N = 5,772) to examine educational needs, behavioral health characteristics, and disease-related interference among individuals with COPD who received services from the American Lung Association (ALA) Lung Helpline. Most participants (73.7%) were interested in COPD-focused information, and few had received prior instruction in breathing exercises (33.9%), energy conservation (26.5%), or airway clearing (32.1%). About one-third of participants engaged in regular exercise, 16.3% followed a special diet, and 81.4% were current smokers. Most participants (78.2%) reported COPD-related interference in daily activities and 30.8% had been hospitalized within the past six months for their breathing. Nearly half of participants (45.4%) reported current symptoms of anxiety or depression. Those with vs. without anxiety/depression had higher rates of COPD-related interference (83.9% vs. 73.5%, p < .001) and past six-month hospitalization (33.4% vs. 28.3%, p < .001). In conclusion, this survey identified strong interest in disease-focused education; a lack of prior instruction in specific self-management strategies for COPD; and behavioral health needs in the areas of exercise, diet, and smoking cessation. Anxiety and depression symptoms were common and associated with greater disease burden, underscoring the importance of addressing coping with negative emotions. Implications for self-management treatments that target multiple behavioral needs of COPD patients are discussed.