PROMIS: Physical, Mental and Social Health Outcomes Improve From Before to Early After LVAD Implant: Findings From the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL) Study.

Study participants (n = 272) completed 12 Patient-Reported Outcomes Measurement Information System (PROMIS) physical, mental and social health measures (questionnaires) prior to implantation of a left ventricular assist device (LVAD) and again at 3 and 6 months postimplant. All but 1 PROMIS measure demonstrated significant improvement from pre-implant to 3 months; there was little change between 3 and 6 months. Because PROMIS measures were developed in the general population, patients with an LVAD, their caregivers and their clinicians can interpret the meaning of PROMIS scores in relation to the general population, helping them to monitor a return to normalcy in everyday life.

Research engagement and experiences of patients pre- and post-implant of a left ventricular assist device from the mechanical circulatory support measures of adjustment and quality of life (MCS A-QOL) study.

PURPOSE: Adults living with mechanical circulatory support (MCS) present with unique challenges (e.g., left ventricular assist device [LVAD]-related self-care, adverse events) to research study enrollment, engagement, and completion. The purpose of this study was to understand the experiences of adults with MCS who were eligible for and enrolled in a study of health-related quality of life (HRQOL). METHODS: In a secondary analysis of data from the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life study, we used a mixed-methods approach to evaluate research engagement and experiences among adults preparing to undergo or currently living with MCS implant. First, we assessed the cascade of study engagement. Second, we assessed research experiences using a structured interview developed for this study. RESULTS: Of 1011 participants approached for the study, 86.7% enrolled, 12.7% declined, and 0.6% were ineligible. Of 877 participants enrolled, 272 were pre-implant (of whom 88% completed assessments; "respondents") and 605 were post-implant (of whom 74% completed assessments). Only 14% of respondents reported difficulty completing the questionnaires, 54% had previously used an iPad to complete questionnaires, and 62% reported that their experience was "as expected." Respondents qualitatively described both positive (e.g., value of research) and negative (e.g., too much time) research experiences, difficulties completing questionnaires (e.g., online platform, health literacy issues), and provided recommendations for the questionnaires and delivery. CONCLUSIONS: Participants enjoyed participating in HRQOL research focused on MCS and had unique perspectives for improving the questionnaires. It is important to minimize the burden of participation and critical to be flexible to meet participant preferences for research engagement. TRIAL REGISTRATION: NCT03044535 (accessible at https://clinicaltrials.gov/ct2/show/NCT03044535 ), registered February 7, 2017.

A Low Literacy, Multimedia Health Information Technology Intervention to Enhance Patient-Centered Cancer Care in Safety Net Settings Increased Cancer Knowledge in a Randomized Controlled Trial.

We tested whether a low-literacy-friendly, multimedia information and assessment system used in daily clinical practice enhanced patient-centered care and improved patient outcomes. This was a prospective, parallel-group, randomized controlled trial with 2 arms, CancerHelp-Talking Touchscreen (CancerHelp-TT) versus control, among adults with Stage I-III breast or colorectal cancer receiving chemotherapy and/or radiation therapy in safety net settings. Each patient was assessed for outcomes at 4 timepoints: after starting treatment (baseline), during treatment, immediately after treatment, and at follow-up assessment. The primary outcomes were health beliefs, cancer knowledge, self-efficacy, and satisfaction with communication about cancer and its treatments. Health-related quality of life (HRQOL) was a secondary outcome. A total of 129 patients participated in the study (65 intervention and 64 control), and approximately 50% of these completed the study. Patients randomized to receive the CancerHelp-TT program had a significantly larger increase in their cancer knowledge in comparison to those randomized to the control arm (effect size = .48, P = .05). While effect sizes for differences between randomized groups in self-efficacy, health beliefs, HRQOL, and satisfaction with communication were small (.10-.48), there was a consistent trend that participants in the intervention group showed larger increases over time in all outcomes compared to the control group. The CancerHelp-TT software was favorably rated by intervention participants. The CancerHelp-TT program showed promise to increase vulnerable cancer patients' cancer knowledge and adaptive health beliefs and attitudes. However, vulnerable patients may need additional interventional support in settings outside cancer clinics.

Rasch Analysis of Social Attitude Barriers and Facilitators to Participation for Individuals with Disabilities.

OBJECTIVES: To develop item banks of social attitude barriers and facilitators to participation and validate them with established instruments. DESIGN: We used the Rasch model to identify misfitting items and rating scale problems, calibrate items, and develop KeyForms and short forms. Correlations between the Social Attitude Barriers and Facilitators item banks with the Patient-Reported Outcomes Measurement Information System (PROMIS) Social Health domain and National Institutes of Health Toolbox Emotional Battery Social Relationships domain were computed to evaluate convergent and divergent validity. SETTING: Community-dwelling individuals traveled to 3 academic medical centers for testing. PARTICIPANTS: Participants (N=558) who had a primary impairment of stroke, spinal cord injury, or traumatic brain injury (mean age, 47.0±16.0y) completed 31 social attitude facilitator and 51 barrier items using a 5-point rating scale. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Item banks to measure social attitude barriers and facilitators for individuals with disabilities. RESULTS: After combining the "never" and "rarely" rating scale categories, 30 Facilitator items fit the Rasch model and demonstrated person reliability of 0.93. After collapsing the "never" and "rarely" rating scale categories, 45 Barrier items fit the Rasch model and demonstrated person reliability of 0.95. Ceiling and floor effects were negligible for both item banks. Facilitators and Barriers item banks were negatively correlated, and these banks were moderately correlated with PROMIS and Toolbox measures, providing evidence of convergent and divergent validity. CONCLUSIONS: Findings support the reliability and validity of the Social Attitude Facilitators and Barriers item banks. These item banks allow investigators and clinicians to measure perceptions of social attitudes, providing information that can guide individual interventions to reduce barriers and promote facilitators. Moderate correlations between the Social Attitude banks and PROMIS and Toolbox variables provide support for the measurement and theory of environmental influences on social health and participation.

Assessing meaning & purpose in life: development and validation of an item bank and short forms for the NIH PROMIS®.

PURPOSE: A sense of meaning and purpose is important for people living with acute and chronic illness. It can buffer the effects of stress and facilitate adaptive coping. As part of the Patient-Reported Outcomes Measurement Information System (PROMIS), we developed and validated an item response theory (IRT)-based measure of meaning and purpose in life. METHODS: Informed by a literature review and patient and content-expert input, we wrote 52 items to assess meaning and purpose and administered them to a general population sample (n = 1000) along with the Meaning in Life Questionnaire-Presence of Meaning Subscale (MLQ-Presence) and the Life Engagement Test (LET). We split the sample in half for exploratory factor analysis (EFA) followed by confirmatory factor analysis (CFA). IRT analyses included assessments of differential item functioning (DIF). RESULTS: Participants had a mean age of 47.8 years and 50.3% were male. EFA revealed one dominant factor and CFA yielded a good fitting model for a 37-item bank (CFI = 0.962, TLI = 0.960, RMSEA = 0.085). All items were free of sex, age, education, and race DIF. Internal consistency reliability estimates ranged from α = 0.90 (4-item short form) to α = 0.98 (37-item bank). The 8-item Meaning and Purpose short form was correlated with the MLQ-Presence (r = 0.89), the LET (r = 0.79), and the full PROMIS Meaning and Purpose item bank (r = 0.98). CONCLUSIONS: The PROMIS Meaning and Purpose measures demonstrated sufficient unidimensionality and displayed good internal consistency, model fit, and convergent validity. Further psychometric testing of the PROMIS Meaning and Purpose item bank and short forms in people with chronic diseases will help evaluate the generalizability of this new tool.

Investigation of a multimedia, computer-based approach to improve knowledge, attitudes, self-efficacy, and receptivity to cancer clinical trials among newly diagnosed patients with diverse health literacy skills.

BACKGROUND: Enrollment in therapeutic cancer trials remains low, and is especially challenging for patients with low health literacy. The authors tested an interactive technology designed for patients with diverse health literacy skills with the aim of improving patient receptiveness, willingness, knowledge, self-efficacy, and positive attitudes regarding clinical trials. METHODS: Patients presenting for their first oncology appointment were eligible. Patients viewed an interactive teaching video concerning clinical trials that was adapted from the National Institutes of Health. Validated surveys assessing receptiveness, willingness, knowledge, self-efficacy, and positive attitudes regarding clinical trials were administered before and after the test. RESULTS: A total of 120 patients with cancer were enrolled. Approximately 80% were non-Hispanic white, 33% were female, 69% had >high school education, and 8% reported an income <$20,000. Approximately 33% scored within the low health literacy range. Changes between pretest and posttest demonstrated increases in knowledge (P < .001), self-efficacy (P < .001), and positive beliefs (P = .004); a slight decrease in willingness (P = .009); and no difference in patient receptivity (P = .31). Higher health literacy was associated with improved willingness (P = .049) and non-Hispanic white race was associated with improved receptivity (P = .034). CONCLUSIONS: Interactive technology that was designed for patients with diverse health literacy skills demonstrated the ability to improve knowledge, self-efficacy, and positive beliefs regarding cancer clinical trials. Contrary to the hypothesis of the current study, patients with lower health literacy did not appear to derive a greater advantage from this technology. There was no improvement noted with regard to patient willingness or receptivity, and clinical trial enrollment remained at historical institutional levels. Talking touchscreen technology has a potential role as an important element in informed decision making for patients, but likely needs to be coupled with more robust and multitargeted interventions.

Calibration and initial validation of a general self-efficacy item bank and short form for the NIH PROMIS®.

AIMS: General self-efficacy is associated with adaptive coping and positive health outcomes. The Patient-Reported Outcomes Measurement Information System (PROMIS®) has developed self-efficacy item banks for managing chronic conditions, but lacks a general self-efficacy measure. We sought to refine and validate an item-response theory (IRT)-based measure of general self-efficacy for PROMIS®. METHODS: Ten items were modified from the NIH Toolbox® Self-Efficacy Item Bank by creating "confidence" response options, and administered to a general population sample (n = 1000) with the Toolbox® Self-Efficacy Item Bank, Life Orientation Test-Revised (LOT-R), and Generalized Expectancy for Success Scale (GESS). We split the sample in half for exploratory factor analysis (EFA) followed by confirmatory factor analysis (CFA). IRT analyses included evaluation of differential item functioning (DIF). RESULTS: Participants had a mean age of 47.8 years and 50.3% were male. EFA showed all items loaded onto one dominant factor and CFA yielded a good fitting model for a general self-efficacy bank with confidence response options (CFI = 0.987, TLI = 0.984, RMSEA = 0.090). Items showed no evidence of DIF by gender, age, education, or race. Internal consistency reliability was α = .94 and .88 for a new 10-item general self-efficacy bank and 4-item short form, respectively. The new bank was correlated with the LOT-R (r = .58), the GESS (r = .55), and the Toolbox® Self-Efficacy Item Bank (r = .87). CONCLUSIONS: The PROMIS® General Self-Efficacy measure demonstrated sufficient unidimensionality and displayed good internal consistency reliability, model fit, and convergent validity. Further psychometric testing of the PROMIS® General Self-Efficacy Item Bank and Short Form can evaluate its utility in people with chronic health conditions.

The Development of Two New Computer Adaptive Tests To Evaluate Feelings of Loss in Caregivers of Individuals With Traumatic Brain Injury: TBI-CareQOL Feelings of Loss-Self and Feelings of Loss-Person With Traumatic Brain Injury.

OBJECTIVE: To develop new patient-reported outcome (PRO) measures to better understand feelings of loss in caregivers of individuals with traumatic brain injury (TBI). DESIGN: Cross-sectional survey study. SETTING: Three TBI Model Systems rehabilitation hospitals, an academic medical center, and a military medical treatment facility. PARTICIPANTS: Caregivers (N=560) of civilians with TBI (n=344) or service members/veterans (SMVs) with TBI (n=216). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Feelings of Loss-Self and TBI-CareQOL Feelings of Loss-Person with Traumatic Brain Injury item banks. RESULTS: While the initial exploratory and confirmatory factor analyses of the feelings of loss item pool (98 items) potentially supported a unidimensional set of items, further analysis indicated 2 different factors: Feelings of Loss-Self (43 items) and Feelings of Loss-Person with TBI (20 items). For Feelings of Loss-Self, an additional 13 items were deleted due to item-response theory-based item misfit; the remaining 30 items had good overall model fit (comparative fit index [CFI]=0.96, Tucker-Lewis index [TLI]=.96, root mean squared error of approximation [RMSEA]=.10). For Feelings of Loss-Other, 1 additional item was deleted due to an associated high correlated error modification index value; the final 19 items evidenced good overall model fit (CFI=0.97, TLI=.97, RMSEA=.095). The final item banks were developed to be administered as either a Computer Adaptive Test (CAT) or a short-form (SF). Clinical experts approved the content of the 6-item SFs of the 2 measures (3-week test-retest was r=.87 for Feelings of Loss-Self and r=.85 for Feelings of Loss-Person with TBI). CONCLUSIONS: The findings from this study resulted in the development of 2 new PROs to assess feelings of loss in caregivers of individuals with TBI; TBI-CareQOL Feelings of Loss-Self and TBI-CareQOL Feelings of Loss-Person with TBI. Good psychometric properties were established and an SF was developed for ease of use in clinical situations. Additional research is needed to determine concurrent and predictive validity of these measures in the psychological treatment of those caring for persons with TBI.

The Development of a New Computer-Adaptive Test to Evaluate Strain in Caregivers of Individuals With TBI: TBI-CareQOL Caregiver Strain.

OBJECTIVE: To develop a new measure of caregiver strain for use in caregivers of individuals with traumatic brain injury (TBI), Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Caregiver Strain. DESIGN: Qualitative data, literature reviews, and cross-sectional survey study. SETTING: Three TBI Model Systems rehabilitation hospitals, an academic medical center, and a military medical treatment facility. PARTICIPANTS: Caregivers (N=560) of civilians (n=344) or service members/veterans (SMVs) with TBI (n=216). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: TBI-CareQOL Caregiver Strain Item Bank. RESULTS: Exploratory and confirmatory factor analyses, a graded response model (GRM) and differential item functioning supported the retention of 33 items in the final measure. GRM calibration data was used to inform the selection of a 6-item static short form, and to program the TBI-CareQOL Caregiver Strain computer-adaptive test (CAT). CAT simulation analyses indicated a 0.97 correlation between the CAT scores and the full item-bank. Three-week test-retest reliability was strong (r=0.83). CONCLUSIONS: The new TBI-CareQOL Caregiver Strain CAT and corresponding 6-item short form were developed using established rigorous measurement development standards; this is the first self-reported measure developed to evaluate caregiver strain in caregivers of individuals with TBI.

Understanding Health-Related Quality of Life of Caregivers of Civilians and Service Members/Veterans With Traumatic Brain Injury: Establishing the Reliability and Validity of PROMIS Social Health Measures.

OBJECTIVE: To examine the reliability and validity of the short form (SF) and computer adaptive test (CAT) versions of the Patient-Reported Outcomes Measurement Information System (PROMIS) measures of social health of caregivers of civilians and service members/veterans (SMVs) with traumatic brain injury (TBI). DESIGN: Self-report questionnaires administered through an online data collection platform. SETTING: Hospital and community-based outreach at 3 TBI Model Systems rehabilitation hospitals, an academic medical center, and a military medical treatment facility. PARTICIPANTS: Caregivers (N=560) (344 civilians and 216 military) of individuals with a documented TBI. INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: A total of 5 PROMIS social health measures. RESULTS: All 5 PROMIS social health measures exceeded the a priori criterion for internal consistency reliability (≥0.70); most PROMIS measures met the criterion for test-retest reliability (≥0.70) in the civilian sample; in the SMV sample, test-retest reliability was generally below this criterion, except for social isolation. For both samples, convergent validity was supported by moderate correlations between the 5 PROMIS social health measures and related measures, and discriminant validity was supported by low correlations between PROMIS social health measures and measures of dissimilar constructs. Most PROMIS scores indicated significantly worse social health in both samples of those caring for individuals who were low functioning. Finally, impairment rates in social health were elevated for those caring for low-functioning individuals, especially in the SMV sample. CONCLUSIONS: The PROMIS CAT and SF social health measures have potential clinical utility for use in caregivers of civilians and SMVs with TBI.

Sociocultural Factors Influencing Caregiver Appraisals Following Traumatic Brain Injury.

OBJECTIVE: To investigate the association of the sociocultural variables race/ethnicity, education, and poverty level to caregivers' positive and negative appraisals following traumatic brain injury. DESIGN: Survey. SETTING: Community. PARTICIPANTS: Caregivers (N=344; 216 white; 69 black; 39 Hispanic) of persons with complicated mild to severe TBI at least 1-year postinjury. INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: Modified Caregiver Appraisal Scale (M-CAS); Zarit Burden Interview (ZBI). RESULTS: Black caregivers reported lower levels of perceived burden on both the M-CAS and the ZBI. Black and Hispanic caregivers reported more traditional caregiver ideology (caregiving as a responsibility) than did whites. Greater poverty was associated with higher burden on the M-CAS, lower caregiver satisfaction, and less mastery. Higher education was associated with higher burden on the ZBI and with lower caregiver mastery. CONCLUSIONS: Treatment professionals should be culturally sensitive to the different perspectives that caregivers may have based on sociocultural factors. Sociocultural factors should be considered in research investigating caregiver outcomes, including appraisals.

The TBI-CareQOL Measurement System: Development and Preliminary Validation of Health-Related Quality of Life Measures for Caregivers of Civilians and Service Members/Veterans With Traumatic Brain Injury.

OBJECTIVE: To develop a new measurement system, the Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL), that can evaluate both general and caregiving-specific aspects of health-related quality of life (HRQOL) in caregivers of persons with traumatic brain injury (TBI). DESIGN: New item pools were developed and refined using literature reviews, qualitative data from focus groups, and cognitive debriefing with caregivers of civilians and service members/veterans with TBI, as well as expert review, reading level assessment, and translatability review; existing item banks and new item pools were assessed using an online data capture system. Exploratory and confirmatory factor analysis, item response theory, and differential item functioning analyses were utilized to develop new caregiver-specific item banks. Known-groups validity was examined using a series of independent samples t tests comparing caregivers of low-functioning vs high-functioning persons with TBI for each of the new measures, as well as for 10 existing Patient-Reported Outcomes Measurement Information System (PROMIS) measures. SETTING: Three TBI Model Systems rehabilitation hospitals, an academic medical center, and a military medical treatment facility. PARTICIPANTS: Caregivers (N=560) of civilians (n=344) or service members/veterans with TBI (n=216). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: The TBI-CareQOL measurement system (including 5 new measures and 10 existing PROMIS measures). RESULTS: Exploratory and confirmatory factor analysis, item response theory, and differential item functioning analyses supported the development of 5 new item banks for Feelings of Loss-Self, Feelings of Loss-Person with TBI, Caregiver-Specific Anxiety, Feeling Trapped, and Caregiver Strain. In support of validity, individuals who were caring for low-functioning persons with TBI had significantly worse HRQOL than caregivers that were caring for high-functioning persons with TBI for both the new caregiver-specific HRQOL measures, and for the 10 existing PROMIS measures. CONCLUSIONS: The TBI-CareQOL includes both validated PROMIS measures and newly developed caregiver-specific measures. Together, these generic and specific measures provide a comprehensive assessment of HRQOL for caregivers of civilians and service members/veterans with TBI.

The Development of a New Computer Adaptive Test to Evaluate Feelings of Being Trapped in Caregivers of Individuals With Traumatic Brain Injury: TBI-CareQOL Feeling Trapped Item Bank.

OBJECTIVE: To develop a new patient-reported outcome measure that captures feelings of being trapped that are commonly experienced by caregivers of individuals with traumatic brain injury (TBI). DESIGN: Cross-sectional. SETTING: Three TBI Model Systems rehabilitation hospitals, an academic medical center, and a military medical treatment facility. PARTICIPANTS: Caregivers (N=560) of civilians with TBI (n=344) and caregivers of service members/veterans with TBI (n=216). INTERVENTIONS: Not applicable. OUTCOME MEASURES: Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Feeling Trapped item bank. RESULTS: From an initial item pool of 28 items, exploratory and confirmatory factor analyses supported the retention of 16 items. After graded response model (GRM) and differential item functioning analyses were conducted, 15 items were retained in the final measure. GRM calibration data, along with clinical expert input, were used to choose a 6-item, static short form (SF), and the calibration data were used for programming of the TBI-CareQOL Feeling Trapped computer adaptive test (CAT). CAT simulation analyses produced an r=0.99 correlation between CAT scores and the full item bank. Three-week short-form test-retest reliability was very good (r=0.84). CONCLUSIONS: The new TBI-CareQOL Feeling Trapped item bank was developed to provide a sensitive and efficient examination of the effect that feelings of being trapped, due to the caregiver role, have on health-related quality of life for caregivers of individuals with TBI. Both the CAT and corresponding 6-item SF demonstrate excellent psychometric properties. Future work is needed to establish the responsiveness of this measure to clinical interventions for these caregivers.

Understanding the need for assistance with survey completion in people with Huntington disease.

PURPOSE: In Huntington disease (HD), motor, cognitive, and psychiatric changes can have a detrimental impact on health-related quality of life (HRQOL). The purpose of this paper is to describe the extent and type of assistance needed to complete online HRQOL surveys, and the impact of assistance on HRQOL scores. METHODS: A patient-reported outcome measurement system was developed for HD-specific HRQOL. Individuals across the prodromal and diagnosed disease severity spectrum (n = 532) completed surveys by computer, and reported the amount and type of assistance they received. RESULTS: Some participants (n = 56; 10.5%) did not complete all surveys; this group had larger proportions with late stage disease, racial/ethnic minority status, low education and single marital status, and poorer motor, independence and cognitive function compared to those who completed all surveys (n = 476). Overall, 72% of individuals did not receive assistance, 11% received computer assistance only, and 17% received assistance answering the survey questions. The majority of late stage individuals (78%) received some assistance compared to early stage (29%) and prodromal individuals (< 1%). Those who received assistance had higher proportions with late stage disease, were older, had less education, and had poorer functional and cognitive skills. Before and after adjustment for sociodemographic and clinical characteristics, those who received assistance had poorer scores on some HRQOL outcomes than those who did not receive assistance. CONCLUSIONS: Computer-based assessments are feasible for many persons with HD, although other methods may also be needed. Clinicians and researchers should develop strategies to assist people with HD to complete HRQOL surveys.

Refining and supplementing candidate measures of psychological well-being for the NIH PROMIS®: qualitative results from a mixed cancer sample.

PURPOSE: The Patient-Reported Outcomes Measurement Information System (PROMIS) is a National Institutes of Health initiative designed to improve patient-reported outcomes using state-of-the-art psychometric methods. The aim of this study is to describe qualitative efforts to identify and refine items from psychological well-being subdomains for future testing, psychometric evaluation, and inclusion within PROMIS. METHOD: Seventy-two items from eight existing measures of positive affect, life satisfaction, meaning & purpose, and general self-efficacy were reviewed, and 48 new items were identified or written where content was lacking. Cognitive interviews were conducted in patients with cancer (n = 20; 5 interviews per item) to evaluate comprehensibility, clarity, and response options of candidate items. RESULTS: A Lexile analysis confirmed that all items were written at the sixth grade reading level or below. A majority of patients demonstrated good understanding and logic for all items; however, nine items were identified as "moderately difficult" or "difficult" to answer. Patients reported a strong preference for confidence versus frequency response options for general self-efficacy items. CONCLUSIONS: Altogether, 108 items were sufficiently comprehensible and clear (34 positive affect, 10 life satisfaction, 44 meaning & purpose, 20 general self-efficacy). Future research will examine the psychometric properties of the proposed item banks for further refinement and validation as PROMIS measures.

Effect of a Home-Based Exercise Intervention of Wearable Technology and Telephone Coaching on Walking Performance in Peripheral Artery Disease: The HONOR Randomized Clinical Trial.

Importance: Clinical practice guidelines support home-based exercise for patients with peripheral artery disease (PAD), but no randomized trials have tested whether an exercise intervention without periodic medical center visits improves walking performance. Objective: To determine whether a home-based exercise intervention consisting of a wearable activity monitor and telephone coaching improves walking ability over 9 months in patients with PAD. Design, Setting, and Participants: Randomized clinical trial conducted at 3 US medical centers. Patients with PAD were randomized between June 18, 2015, and April 4, 2017, to home-based exercise vs usual care for 9 months. Final follow-up was on December 5, 2017. Interventions: The exercise intervention group (n = 99) received 4 weekly medical center visits during the first month followed by 8 months of a wearable activity monitor and telephone coaching. The usual care group (n = 101) received no onsite sessions, active exercise, or coaching intervention. Main Outcomes and Measures: The primary outcome was change in 6-minute walk distance at 9-month follow-up (minimal clinically important difference [MCID], 20 m). Secondary outcomes included 9-month change in subcomponents of the Walking Impairment Questionnaire (WIQ) (0-100 score; 100, best), SF-36 physical functioning score, Patient-Reported Outcomes Measurement Information System (PROMIS) mobility questionnaire (higher = better; MCID, 2 points), PROMIS satisfaction with social roles questionnaire, PROMIS pain interference questionnaire (lower = better; MCID range, 3.5-4.5 points), and objectively measured physical activity. Results: Among 200 randomized participants (mean [SD] age, 70.2 [10.4] years; 105 [52.5%] women), 182 (91%) completed 9-month follow-up. The mean change from baseline to 9-month follow-up in the 6-minute walk distance was 5.5 m in the intervention group vs 14.4 m in the usual care group (difference, -8.9 m; 95% CI, -26.0 to 8.2 m; P = .31). The exercise intervention worsened the PROMIS pain interference score, mean change from baseline to 9 months was 0.7 in the intervention group vs -2.8 in the usual care group (difference, 3.5; 95% CI, 1.3 to 5.8; P = .002). There were no significant between-group differences in the WIQ score, the SF-36 physical functioning score, or the PROMIS mobility or satisfaction with social roles scores. Conclusions and Relevance: Among patients with PAD, a home-based exercise intervention consisting of a wearable activity monitor and telephone coaching, compared with usual care, did not improve walking performance at 9-month follow-up. These results do not support home-based exercise interventions of wearable devices and telephone counseling without periodic onsite visits to improve walking performance in patients with PAD. Trial Registration: clinicaltrials.gov Identifier: NCT02462824.

Responsiveness of 8 Patient-Reported Outcomes Measurement Information System (PROMIS) measures in a large, community-based cancer study cohort.

BACKGROUND: The Patient-Reported Outcomes Measurement Information System (PROMIS) was a National Institutes of Health-funded initiative to develop measures of symptoms and function. Responsiveness is the degree to which a measure can detect underlying changes over time. The objective of the current study was to document the responsiveness of 8 PROMIS measures in a large, population-based cancer cohort. METHODS: The Measuring Your Health study recruited 2968 patients who were diagnosed with 1 of 7 cancers between 2010 and 2012 through 4 Surveillance, Epidemiology, and End Results registries. Participants completed a baseline survey (6-13 months after diagnosis) and a 6-month follow-up survey. Changes in 8 PROMIS scores were compared with global ratings of transition, changes in performance status, and clinical events. RESULTS: Measures were responsive to 6-month declines and improvements in performance status with small to large effect sizes (ES) (Cohen d = 0.34-0.71; P < .01). Mean changes and effect sizes were larger for participants who reported declines compared with those who reported improvements. Small-to-medium ES were observed in patients who reported being "a little" worse (d = 0.31-0.56), and medium-to-large ES were observed in those who reported being "a lot" worse (d = 0.53-0.72). Hospitalized participants reported significant score increases, resulting in worsening of pain (d = 0.51), fatigue (d = 0.35), and depression (d = 0.57; all P < .01). Cancer recurrence and progression were associated with smaller increases in pain, fatigue, and sleep disturbance (d = 0.22-0.27). CONCLUSIONS: The current results indicated that all 8 PROMIS measures were sensitive to patient-perceived worsening and improvement and to major clinical events. These findings will be able to inform the design and interpretation of future research studies and clinical initiatives administering PROMIS measures. Cancer 2017;123:327-335. © 2016 American Cancer Society.

Patient-reported outcomes in Huntington's disease: Quality of life in neurological disorders (Neuro-QoL) and Huntington's disease health-related quality of life (HDQLIFE) physical function measures.

BACKGROUND: There is a need for patient-reported outcome measures that capture the impact that motor impairments have on health-related quality of life in individuals with Huntington's disease. OBJECTIVES: The objectives of this study were to establish the reliability and validity of new physical functioning patient-reported outcome measures in Huntington's disease. METHODS: A total of 510 individuals with Huntington's disease completed 2 Quality of Life in Neurological Disorders (Lower Extremity Function and Upper Extremity Function) and 3 Huntington's Disease Health-Related Quality of Life (Chorea, Speech Difficulties, and Swallowing Difficulties) measures. Clinician-rated and generic self-report measures were also administered. RESULTS: Reliabilities for the new patient reported physical functioning measures were excellent (all Cronbach's α > .92). Convergent, discriminant validity and known group validity was supported. CONCLUSIONS: The results provide psychometric support for new patient-reported physical functioning measures and the fact that these measures can be used as clinically meaningful endpoints in Huntington's disease research and clinical practice. © 2017 International Parkinson and Movement Disorder Society.

The challenge of measuring intra-individual change in fatigue during cancer treatment.

PURPOSE: To evaluate how well three different patient-reported outcomes (PROs) measure individual change. METHODS: Two hundred and fourteen patients (from two sites) initiating first or new chemotherapy for any stage of breast or gastrointestinal cancer participated. The 13-item FACIT Fatigue scale, a 7-item PROMIS® Fatigue Short Form (PROMIS 7a), and the PROMIS® Fatigue computer adaptive test (CAT) were administered monthly online for 6 months. Reliability of measured change was defined, under a population mixed effects model, as the ratio of estimated systematic variance in rate of change to the estimated total variance of measured individual differences in rate of change. Precision of individual measured change, the standard error of measurement of change, was given by the square root of the rate-of-change sampling variance. Linear and quadratic models were examined up to 3 and up to 6 months. RESULTS: A linear model for measured change showed the following by 6 and 3 months, respectively: PROMIS CAT (0.363 and 0.342); PROMIS SF (0.408 and 0.533); FACIT (0.459 and 0.473). Quadratic models offered no noteworthy improvement over linear models. Both reliability and precision results demonstrate the need to improve the measurement of intra-individual change. CONCLUSIONS: These results illustrate the challenge of reliably measuring individual change in fatigue with a level of confidence required for intervention. Optimizing clinically useful measurement of intra-individual differences over time continues to pose a challenge for PROs.

Sexual Satisfaction and the Importance of Sexual Health to Quality of Life Throughout the Life Course of U.S. Adults.

INTRODUCTION: Discussions about sexual health are uncommon in clinical encounters, despite the sexual dysfunction associated with many common health conditions. Understanding of the importance of sexual health and sexual satisfaction in U.S. adults is limited. AIM: To provide epidemiologic data on the importance of sexual health for quality of life and people's satisfaction with their sex lives and to examine how each is associated with demographic and health factors. METHODS: Data are from a cross-sectional self-report questionnaire from a sample of 3,515 English-speaking U.S. adults recruited from an online panel that uses address-based probability sampling. MAIN OUTCOME MEASURES: We report ratings of importance of sexual health to quality of life (single item with five-point response) and the Patient-Reported Outcomes Measurement Information System Satisfaction With Sex Life score (five items, each with five-point responses, scores centered on the U.S. mean). RESULTS: High importance of sexual health to quality of life was reported by 62.2% of men (95% CI = 59.4-65.0) and 42.8% of women (95% CI = 39.6-46.1, P < .001). Importance of sexual health varied by sex, age, sexual activity status, and general self-rated health. For the 55% of men and 45% of women who reported sexual activity in the previous 30 days, satisfaction with sex life differed by sex, age, race-ethnicity (among men only), and health. Men and women in excellent health had significantly higher satisfaction than participants in fair or poor health. Women with hypertension reported significantly lower satisfaction (especially younger women), as did men with depression or anxiety (especially younger men). CONCLUSION: In this large study of U.S. adults' ratings of the importance of sexual health and satisfaction with sex life, sexual health was a highly important aspect of quality of life for many participants, including participants in poor health. Moreover, participants in poorer health reported lower sexual satisfaction. Accordingly, sexual health should be a routine part of clinicians' assessments of their patients. Health care systems that state a commitment to improving patients' overall health must have resources in place to address sexual concerns. These resources should be available for all patients across the lifespan.