PROMIS Global Health Research Articles

African Immigrant and Refugee Families Perceptions on Informational Support and Health Status: A Comparison of African Immigrants Living in South Africa and the United States

The relationship between migration and health is complex, and its impact varies considerably among individuals, across migrant groups, and from country to country. Although African immigration to the United States (U.S.) and South Africa has increased rapidly over the past two decades, little is known about the health experiences of this growing population even though conditions surrounding the migration process have been found to increase vulnerability to ill health. The aim of this study is to examine and compare the perceptions of African refugees and immigrants to South Africa and the U.S. on informational support and its impact on health status. Data was collected from purposively selected 62 African immigrants to the United States and 66 African immigrants to South Africa using the PROMIS Global Health v1.2 and the PROMIS Item Bank v2.0 (informational support) instruments which assess an individuals' general physical, mental and social health.

Adjuvant Doxycycline to Enhance Anti-Amyloid Effects: Results from the DUAL (Doxycycline to Upgrade response in AL amyloidosis) Study

Background: Light chain (AL) amyloidosis is associated with misfolded, insoluble fibril deposits in vital organs such as the heart, kidneys, liver, and nerves, derived from immunoglobulin light chains made by clonal plasma cells. Plasma cell-directed, standard-of-care chemotherapy has no effect on pre-formed fibrils. Hematologic response is thus insufficient for organ amyloid responses and organ improvement can lag hematologic response by months to years. Fibril-directed therapies are critical to improve early mortality of AL. Doxycycline has been reported to produce fibril disruption, reduce AL deposits and control light chain toxicity. It has been studied in localized AL amyloidosis and other amyloid subtypes. We conducted a phase 2 trial of doxycycline for use in conjunction with chemotherapy in AL. Herein, we report the outcomes of systemic AL patients treated on this study.Patients and Methods: This was an open label, single center, phase 2 pilot trial listed under clinicaltrials.gov (NCT02207556). The study was opened between 12/2014 - 06/2017. The last patient completed end-of-study assessment in 07/2018. Based on predominant symptoms and organ involvement, each patient was labeled to have 1 target amyloid organ involved. Patients were treated with oral doxycycline 100 mg twice daily in conjunction with chemotherapy per physician discretion. Patients were staged using the 2012 staging system. Hematologic and organ responses were categorized based on the consensus guidelines for conduct and reporting of clinical trials in AL amyloidosis published in 2012 for cardiac, renal and hepatic organ involvement and by radiologic measures for soft tissue involvement. The objectives were to study early mortality at 1, 3, 6, and 12 months after enrollment, target amyloid organ response rates at 6 and 12 months, and quality of life (QoL) using the PROMIS Global Health Index at 3-monthly intervals during the study.Results: Of 31 patients enrolled on this study, 25 had systemic AL (6 patients with localized AL syndromes will be described separately). The median age at diagnosis was 61.3 years (range 38.3-77.3), 64% were male, 2012 stage was I in 3 (12%), II in 9 (36%), III in 6 (24%) and IV in 7 (28%). The amyloid clone was lambda in 17 (68%). The median baseline values with range were: hemoglobin 12.3 (9.7-16.5) g/dL, albumin 3.7 (1.1-4.8) g/dL, creatinine 1.07 (0.6-2.42) mg/dL, 24-hour urine protein 0.97 (0.15-16.7) g/day and alkaline phosphatase 77 (42-597) IU/L. The median difference in involved and uninvolved free light chains was 258.6 (26-978.4) mg/L, NT-proBNP was 2564 (65-18333) pg/mL and troponin T was 0.017 (<0.011-0.342) ng/mL. Among AL organ involvement, 16% had 1, 24% had 2, 16% had 3, and 44% had >3 organs involved with amyloid, with 60% cardiac, 72% renal, 24% hepatic, 36% soft tissue, 28% gastrointestinal, 20% autonomic nervous system, and 8% peripheral nerve AL involvement. The median follow-up was 21.4 (12.2-40.3) months.All patients received concurrent CyBorD chemotherapy. Early mortality was 0 at 1 month, 2 (8%) at 3 months, 3 (12%) at 6 months and 5 (20%) at 1 year. Target organ involvement and responses at 6 and 12 months are shown in the table. In an intent-to-treat analysis of organ responses, at 6 months 24% had response, 32% had stable disease and 44% had progression (including 3 deaths prior to 6 months). At 12 months, 36% had target organ response, 32% had stable disease and 36% had progression (including 5 deaths). QoL showed improvement in both physical and mental domains at the end of treatment (figure). Overall hematologic response among survivors was 100% at 1-year including 40% complete, 45% very good, and 15% partial responses. The most common adverse event was skin rash and photosensitivity. One patient with end-stage heart failure and multiple hospitalizations, developed Clostridium difficile diarrhea while hospitalized, during the study period. Fifteen patients (60%) underwent melphalan-based autologous stem cell transplantation- 14 within 1 year after diagnosis, and in 1 delayed until relapsed disease 2 years after diagnosis. The 100-day mortality among transplanted patients was 0.Conclusions: In newly diagnosed systemic AL amyloidosis, doxycycline was safe with concurrent chemotherapy. The low 1-year early mortality of 20% and autologous stem cell transplant rate of 60% compares favorably to prior reports. These findings warrant a randomized, multicenter study. [Display omitted] DisclosuresD'Souza:Prothena: Consultancy, Research Funding; Merck: Research Funding; Takeda: Research Funding; Amgen: Research Funding; Celgene: Research Funding. Dhakal:Celgene: Consultancy, Honoraria; Takeda: Honoraria, Research Funding; Amgen: Honoraria. Hari:Janssen: Honoraria; Amgen Inc.: Research Funding; Spectrum: Consultancy, Research Funding; Sanofi: Honoraria, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Takeda: Consultancy, Honoraria, Research Funding; Kite Pharma: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding.

Patient Reported Outcomes in Women With IBS Using Opioids for Chronic Non-Cancer Pain: ACG/Radhika Srinivasan Gender-Based Research Award: Presidential Poster Award

Introduction: Opioids can reduce gut motility, causing a number of adverse GI effects including vomiting, nausea, and constipation. These side effects are further exacerbated in individuals with functional bowel disorders such as IBS. Consequently, opioids are not recommended to treat pain in IBS. Yet, opioids continue to be prescribed at alarming rates particularly for chronic noncancer pain, and there is limited research on the extent to which an IBS diagnosis would discourage a clinician from prescribing narcotics to a patient. We sought to better understand opioid use and health outcomes in women with chronic noncancer pain and comorbid IBS. Methods: Cross-sectional data on comorbidities, current medication use, and patient-reported outcomes relating to physical health, mental health, and pain interference was collected as part of a larger study assessing patient preferences for chronic noncancer pain management. We conducted a subgroup analysis on respondents who selected IBS as a comorbidity (N = 209), restricting the sample to females (N = 194) due to insufficient male response (N = 15). Linear regressions were used to examine differences in PROMIS t-scores for mental health, physical health, and pain interference among opioid users and non-users, after adjusting for age and ethnicity. Results: 42.8% of female respondents with chronic pain and comorbid IBS reported currently using opioids compared to 36.3% of women without IBS (p = 0.107). Respondents had mean t-scores of 38, 32, and 64 for mental health, physical health, and pain interference, respectively. Adjusting for age and ethnicity, women using opioids reported lower PROMIS mental health scores (B = -4.37; p = 0.018) and physical health scores (B = -3.15; p < 0.001) than those not using opioids. Pain interference did not differ between women using opioids and those not using opioids, independent of age and ethnicity (p = 0.652).Conclusion: Opioid use in women with chronic pain and comorbid IBS was associated with reduced mental and physical health. Pain interference was higher than the general population for women with comorbid IBS, with no improvement in pain interference observed as a result of opioid use. Despite this, women with IBS using opioids to treat a primary pain condition reported similar rates of opioid use as respondents without IBS, indicating that an IBS diagnosis may not discourage opioid prescribing. Further research should investigate the risks and benefits of opioid use in women with chronic pain and IBS.460_A Figure 1. Mean mental health t-score as measured by PROMIS Global Health for women with comorbid IBS currently using opioids and those not using opioids.460_B Figure 2. Mean physical health t-score as measured by PROMIS Global Health for women with comorbid IBS currently using opioids and those not using opioids.460_C Figure 3. Mean pain interference t-score as measured by PROMIS Pain Interference for women with comorbid IBS currently using opioids and those not using opioids.

Proceedings of Contributed Presentations 10th World Federation of Chiropractic/Association of Chiropractic Colleges Education Conference

Proceedings of Contributed Presentations 10th World Federation of Chiropractic/Association of Chiropractic Colleges Education Conference

Contextualizing the lived experience of quality of life for persons with spinal cord injury: A mixed-methods application of the response shift model

Objective: The objective of this study was to gain greater insight into individuals’ quality of life (QOL) definitions, appraisals, and adaptations following spinal cord injury (SCI).Design: A mixed-methods design, applying the Schwartz and Sprangers response shift (RS) model. RS is a cognitive process wherein, in response to a change in health status, individuals change internal standards, values, or conceptualization of QOLSetting: Community-dwelling participants who receive medical treatment at a major Midwestern medical system and nearby Veterans’ Affairs hospital.Participants: A purposive sample of participants with SCI (N = 40) completed semi-structured interviews and accompanying quantitative measures.Interventions: Not applicable.Outcome Measures: Qualitative data were analyzed using content analysis to identify themes. Analysis of variance were performed to detect differences based on themes and QOL, well-being, and demographic and injury characteristics.Results: Four RS themes were identified, capturing the range of participant perceptions of QOL. The themes ranged from complete RS, indicating active engagement in maintaining QOL, to awareness and comparisons redefining QOL, to a relative lack of RS. Average QOL ratings differed as a function of response shift themes. PROMIS Global Health, Anxiety, and Depression also differed as a function of RS themes.Conclusion: The RS model contextualizes differences in QOL definitions, appraisals, and adaptations in a way standardized QOL measures alone do not.

Rationale for routine collection of patient reported outcomes during integrative medicine consultation visits

ObjectivesIntegrative medicine (IM) is whole-person care utilizing complementary health approaches to address numerous physical or emotional influences that can impact an individual’s health. Patient-reported outcomes (PRO) are subjective measures that quantify patients’ perception of their quality of life. While PRO measures have been routinely assessed in specific oncology clinics, our objective was to assess the ability and utility of routine collection of PRO measures in an IM clinic. Design/setting/main outcomePatients receiving a clinical consultation in an ambulatory IM clinic completed the PROMIS Global Health Form in the clinic waiting room. ResultsFrom November 2013 through October 2016, the PROMIS Global Health Form (PROMIS-10) was administered during 59% of IM provider consultation visits (7172/12,207), representing 3473 unique patients. Most patients were female (81%), White (93%), middle-aged (49.2; SD 15.4) and had commercial health insurance (66%). Baseline Mental (44.9; SD 9.1) and Physical Health (44.2; SD 8.6) scores were roughly 0.5 standard deviation below the national mean values (50; SD 10). Factors such as age, race and non-commercial insurance were associated with lower PROMIS-10 scores. Patients completing at least two PROMIS-10 questionnaires (n = 1541) exhibited increases of 2.3% and 2.8% from first to last PROMIS-10 assessment in Mental and Physical Heath scores respectively. ConclusionsIt is possible to routinely collect PRO measures in large IM clinic and longitudinal improvements in Mental and Physical Health scores were observed. Future research should focus on understanding how providers can utilize PRO results in real-time to improve patients’ clinical outcomes and potentially decrease healthcare utilization.

Evaluating the reliability and construct validity of the Eckardt symptom score as a measure of achalasia severity

Achalasia is a disease of mechanical esophageal dysfunction characterized by dysphagia, chest pain, regurgitation, and malnutrition. The Eckardt symptom score (ESS) is the gold standard self-report assessment tool. Current guidelines outline a three-step approach to patient reported outcomes measure design. Developed prior to these policies, the ESS has not undergone rigorous testing of its reliability and validity. Adult achalasia patients retrospectively identified via a patient registry were grouped based on treatment history. Patients were grouped PREPOST (completed ESS, GERDQ, brief esophageal dysphagia questionnaire, NIH PROMIS Global Health, high resolution manometry, timed barium esophagram prior to treatment and after) and POST (completed measures only after treatment). Clinical characteristics, treatment type and date were obtained via medical record. Standardized psychometric analyses for reliability and construct validity were performed. 107 patients identified; 83 POST and 24 PREPOST. The ESS has fair internal consistency and split-half reliability with a single factor structure. Dysphagia accounts for half the variance in ESS, while chest pain and weight loss account for 10% each. Pre-post-surgical assessment demonstrates improvements in ESS, except for weight loss. Effect sizes range from 0.24 to 2.53, with greatest change in regurgitation. Validity of the ESS is supported by modest correlations with GERDQ, HRQOL, and physiological data. The ESS demonstrates fair reliability and validity, with a single factor structure mostly explained by dysphagia. Based on psychometric findings, weight loss and chest pain items may be decreasing ESS reliability and validity. Further assessment of the ESS under FDA guidelines is warranted.

Targeted spine strengthening exercise and posture training program to reduce hyperkyphosis in older adults: results from the study of hyperkyphosis, exercise, and function (SHEAF) randomized controlled trial.

The purpose of the present study is to determine in a randomized controlled trial whether spine-strengthening exercises improve Cobb angle of kyphosis in community-dwelling older adults. We recruited adults ≥60years with kyphosis ≥40° and enrolled 99 participants (71 women, 28 men), mean age 70.6±0.6years, range 60-88, with baseline Cobb angle 57.4±12.5°. The intervention included group spine-strengthening exercise and postural training, delivered by a physical therapist, 1-h, three times weekly for 6months. Controls received four group health education meetings. The primary outcome was change in the gold standard Cobb angle of kyphosis measured from standing lateral spine radiographs. Secondary outcomes included change in kyphometer-measured kyphosis, physical function (modified Physical Performance Test, gait speed, Timed Up and Go, Timed Loaded Standing, 6-Min Walk), and health-related quality of life (HRQoL) (PROMIS global health and physical function indexes, SRS-30 self-image domain). ANCOVA was used to assess treatment effects on change from baseline to 6months in all outcomes. There was a -3.0° (95% CI -5.2, -0.8) between-group difference in change in Cobb angle, p=0.009, favoring the intervention and approximating the magnitude of change from an incident vertebral fracture. Kyphometer-measured kyphosis (p=0.03) and SRS-30 self-esteem (p<0.001) showed favorable between-group differences in change, with no group differences in physical function or additional HRQoL outcomes, p>0.05. Spine-strengthening exercise and posture training over 6months reduced kyphosis compared to control. Our randomized controlled trial results suggest that a targeted kyphosis-specific exercise program may be an effective treatment option for older adults with hyperkyphosis. ClinicalTrials.gov; identifier NCT01751685.

Using a Self-Reported Global Health Measure to Identify Patients at High Risk for Future Healthcare Utilization.

Research studies have shown that patient-reported outcome measures (PROMs) that assess global health are helpful for predicting health care utilization, but less evidence exists that collection of PROMs in routine care can identify patients with high health care needs. To investigate the association between the PROMIS Global Health (PGH) scores and subsequent health care utilization among patients in a large accountable care organization (ACO). Retrospective cohort study of individuals in the Partners HealthCare ACO who completed at least one PGH during a primary care visit. A total of 2639 individuals who completed at least one PGH and who also had 12months of ACO membership and/or claims data prior to the PROM completion and at least one month of claims data post-PGH completion. The main outcomes were the rates of emergency department (ED) visits and hospitalizations by quartile of PGH physical and mental health scores. We also compared the predictive accuracy of administrative data models with and without the PGH scores to identify the highest utilizers. The group with the worst (lowest) physical and mental health scores had significantly higher rates of hospitalization (RR 5.14, 95% CI 2.37, 11.15; and 2.27, 95% CI 1.06, 4.85, respectively) than those with higher scores. After adjustment for demographic and clinical factors, only the group with lower physical health scores had higher rates of hospitalization (RR 3.15, 95% CI 1.30, 7.90). The addition of the physical health subscore to administrative data increased the sensitivity to detect the top 5% of hospital utilizers compared with administrative data alone (44.0% vs. 36.0% respectively). Worse self-reported physical health, measured during routine primary care, is associated with significantly higher rates of hospitalization. It is not associated with increased rates of ED visits. Self-reported physical health modestly increases the sensitivity to detect the highest hospital utilizers.

ACC Research Agenda Conference 2018: Peer Reviewer Acknowledgments and Abstracts of Proceedings

ACC Research Agenda Conference 2018: Peer Reviewer Acknowledgments and Abstracts of Proceedings

Randomized Controlled Trial of Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis

Category: Sports Introduction/Purpose: Initial treatment of plantar fasciitis (PF), consisting of anti-inflammatories, stretching and in-shoe orthosis (heel pad, heel wedge, or arch support), leads to symptomatic resolution in over 90% of patients but takes 3-6 months. This study was conducted to test the effectiveness of a minimally invasive modality, intense therapeutic ultrasound (ITU), in accelerating the healing of chronic plantar fasciitis (PF). ITU uses high-frequency high-intensity focused ultrasound to create small thermal injury zones inside soft tissue without damage to surrounding structures. ITU has been shown to initiate a tissue repair cascade and promote collagen generation in dermal and musculoskeletal tissue and is FDA approved for use in non-surgical brow lifts [1,2]. The goal of this study was to determine if ITU when combined with standard therapy could speed the healing of chronic PF. Methods: 47 patients with chronic (greater than 3 months) heel pain due to PF were randomized to standard therapy (anti- inflammatory pills, stretching, and gel heel cups) plus ITU (“ITU”, n=33) or standard therapy plus sham ITU (“control”, n=14) groups. ITU treatments were administered at enrollment and two-weeks later using a custom 3.3 MHz therapeutic ultrasound system (Guided Therapy Systems, Mesa, AZ). Sham treatment utilized the same protocol but with the energy set to 0 Joules. Treatment effect was assessed at 2, 4, 6, and 12 weeks after the initiation of treatment using diagnostic ultrasound and patient reported outcomes (PROMIS physical function computer adaptive test, PROMIS global health, Foot Function Index pain subscale, and a non-validated heel pain specific questionnaire). Ultrasound images were analyzed to determine the size of lesions within the PF. Both the sonographer and the study coordinator administering the patient reported outcome instruments were blinded to group assignment. Results: 38 patients completed the 12 week study (ITU: n=37, Control: n=11.). The ITU group reported a significantly greater reduction in heel pain scores [Mean 8.27, SD 4.69, P=0.027] compared to the control group [Mean 2.25, SD 5.92] (Figure 1). Ultrasound imaging showed an 81% decrease in perifascial lesion size in the treatment group, compared to a 26% increase in lesion size in the control group (Figure 2). Conclusion: Preliminary results of this clinical study of noninvasive ITU for the treatment of chronic PF showed that ITU treatment as compared to sham control lead to a larger and more rapid reduction of heel pain and perifascial lesion size. ITU holds promise as a potential therapy to accelerate the healing of chronic plantar fasciitis

Responsiveness Comparison of the EQ-5D, PROMIS Global Health, And VR-12 Questionnaires In Knee Arthroscopy

Objectives:The EQ-5D, PROMIS 10 Global Health, and VR-12 are generic patient reported outcome (PRO) questionnaires that assess and report patient general health and wellbeing. In choosing a PRO to track patient general health status, it is necessary to consider which measure will be the most responsive to change after treatment. To date, no studies exist comparing the responsiveness among the EQ-5D, PROMIS 10 Global Health, and VR-12. We sought to determine which of the generic PROs were most responsive internally and externally in the setting of knee arthroscopy.Methods:50 patients undergoing knee arthroscopy were surveyed with a PRO questionnaire pre-operatively and at least 3 months post-operatively. PROs included the EQ-5D, EQ-5D visual analog scale, PROMIS 10 Global Health (PROMIS 10) Physical and Mental components, VR-12 Physical and Mental components, and the Knee injury and Osteoarthritis Outcome Score (KOOS) Pain scale. Internal responsiveness was evaluated by performing paired t-tests on the changes in measures and calculation of two measures of effect size: Cohen’s D and standardized response mean (SRM). External responsiveness was evaluated by calculating and comparing Pearson correlation measures between the disease specific reference KOOS Pain and the general PROs EQ-5D, PROMIS 10, and VR-12 changes. General PRO responsiveness measures were compared head to head with the cocor package in R software.Results:Patients were surveyed pre-operatively and a mean of 3.6 months post-operatively with 90% follow-up. For internal responsiveness, the EQ-5D, VR-12 Physical, and PROMIS 10 Physical scales showed a statistically significant improvement in score after treatment and effect size statistics with moderate change (Cohen’s D and SRM between 0.5-0.8). Assessing external responsiveness, the EQ-5D, VR-12 Physical, and PROMIS 10 Physical instruments showed the highest correlation with the disease specific reference measure, KOOS Pain (Table 1). For both internal and external responsiveness, the EQ-5D, VR-12 Physical, and PROMIS 10 Physical instruments showed significantly higher responsiveness compared to the other general PRO measures, but no statistical differences among themselves.Conclusion:There is no statistical difference between the EQ-5D, VR-12 Physical, and PROMIS 10 Physical instruments in terms of internal or external responsiveness to change. In tracking longitudinal patient health, researchers and administrators have the flexibility to choose any of the general PROs among the EQ-5D, VR-12 Physical, and PROMIS 10 Physical instruments. We recommend that any study tracking PROs in knee arthroscopy include one of these generic instruments.

Reliability and validity of the patient activation measure in hospitalized patients

ObjectiveThe purposes of this paper are to describe the internal consistency reliability and construct validity of the PAM-13 for hospitalized cardiology and oncology patients and to examine the predictors of low patient activation in the same population. MethodsWe evaluated the internal consistency reliability of the PAM-13 in the inpatient setting. Construct validity of the PAM-13 was then assessed using two approaches: expected known-groups differences between patients with planned and unplanned admissions PAM-13 levels and convergence of PAM-13 levels with other measures. ResultsThe PAM demonstrated adequate internal consistency overall (Cronbach α=0.81). Patients with unplanned admissions were more likely to have low activation than patients with planned admissions (adjusted OR=5.7, p=0.008). The PAM-13 was modestly correlated (p<0.001) with each of the PROMIS Global Health components used in this study (global, physical and mental health). ConclusionThis study demonstrates the PAM-13 is a reliable and valid measure for use in the inpatient hospital setting and that type of admission (planned versus unplanned) is an important predictor of patient activation. Practice implicationsBy measuring patient activation with the PAM-13, clinicians and researchers can provide tailored communication and care strategies to meet patient’s needs.

Evaluation of the Charing Cross Venous Ulcer Questionnaire in patients with chronic venous ulcers in Uruguay

Chronic venous ulcers (CVU) represent a frequent condition, with difficult therapeutic approaches, that impact on patients’ quality of life, and generate an economic burden to patients and health systems. To perform the cultural adaptation and initial evaluation of the Charing Cross Venous Ulcer Questionnaire (CCVUQ) for Uruguay, and to study the health-related quality of life (HRQL) of patients with CVU. The translated and culturally adapted version of the CCVUQ was applied to a convenience sample of 50 patients. In addition, the PROMIS Global Health Survey was included in the assessment. Both questionnaires showed good internal consistency (Cronbach alfa > 0.70). A statistically significant association was observed between the CCVUQ total scores, its subscales and both dimensions of the PROMIS: Global Physical (GPH) and Global Mental Health (GMH) (rho ≥ 0.40). The CCVUQ mean score was 54.9 ± 42 points while GPH and GMH mean scores were 37.9 ± 29 points, and 43.1 ± 35.1 points respectively. Simple linear regression showed that patients with higher income reported better emotional well-being, while in younger patients, ulcers had a higher impact on Emotional Status and Cosmetics. The translated and adapted version of the CCVUQ was easy to comprehend and apply, showing good psychometric properties. When used in association with the PROMIS Global Health Measure it provides complementary information. HRQL was severely affected in the study sample.

The Impact of Strong for Life on the Physical Functioning and Health of Older Adults Receiving Home and Community-Based Services.

To test the effects of Strong for Life (SFL) on the physical performance and self-rated health of older adults receiving Home and Community-Based Services (HCBS). Randomized, two-group trial with pre-post measures. In-home exercise program. Clients aged 65-95 (n=42) and their Home Care Aide (HCA) (n=32) were randomly assigned to a usual care and SFL intervention or usual care control group. Clients were instructed in SFL by their HCA and completed SFL 3 times per week for 12-weeks. Outcomes included grip and quadriceps strength, Timed Up and Go, gait speed, Self-Efficacy for Exercise, pain, and PROMIS-global health measured at baseline and immediately following the intervention. Clients completed opened ended survey items on SFL program evaluation. Effect sizes were moderate for grip strength (d= .38), pain (d= .34), and PROMIS-global health (d= .27). Small effect sizes were found for all other measures. Median quadriceps and TUG scores differentially improved among intervention participants versus controls. No adverse health events and high program satisfaction were reported. Frailty prevalence in the control group increased between baseline and post-test while frailty prevalence in the intervention group decreased during the same time period. Strong for Life has the potential to improve the strength, mobility, health, and frailty of older adults receiving HCBS. This study provides initial evidence of the impact of SFL for older adults receiving HCBS, as well as the safety of the intervention evidenced by the lack of reported adverse events.

Comparative Effectiveness Research and Children With Cerebral Palsy: Identifying a Conceptual Framework and Specifying Measures.

A step toward advancing research about rehabilitation service associated with positive outcomes for children with cerebral palsy is consensus about a conceptual framework and measures. A Delphi process was used to establish consensus among clinicians and researchers in North America. Directors of large pediatric rehabilitation centers, clinicians from large hospitals, and researchers with expertise in outcomes participated (N = 18). Andersen's model of health care utilization framed outcomes: consumer satisfaction, activity, participation, quality of life, and pain. Measures agreed upon included Participation and Environment Measure for Children and Youth, Measure of Processes of Care, PEDI-CAT, KIDSCREEN-10, PROMIS Pediatric Pain Interference Scale, Visual Analog Scale for pain intensity, PROMIS Global Health Short Form, Family Environment Scale, Family Support Scale, and functional classification levels for gross motor, manual ability, and communication. Universal forms for documenting service use are needed. Findings inform clinicians and researchers concerned with outcome assessment.

Linking Physical and Mental Health Summary Scores from the Veterans RAND 12-Item Health Survey (VR-12) to the PROMIS(®) Global Health Scale.

Global health measures represent an attractive option for researchers and clinicians seeking a brief snapshot of a patient's overall perspective on his or her health. Because scores on different global health measures are not comparable, comparative effectiveness research (CER) is challenging. To establish a common reporting metric so that the physical and mental health scores on the Veterans RAND 12-Item Health Survey (VR-12 (©) ) can be converted into scores on the corresponding Patient Reported Outcomes Measurement Information System (PROMIS(®)) Global Health scores. Following a single-sample linking design, participants from an Internet panel completed items from the PROMIS Global Health and VR-12 Health Survey. A common metric was created using analyses based on item response theory (IRT), producing score cross-walk tables for the mental and physical health components of each measure. The linking relationships were evaluated by calculating the standard deviation of differences between the observed and linked PROMIS scores and estimating confidence intervals by sample size. Participants (N = 2025) were 49 % male and 73 % white; mean age was 46 years. Mental and physical health subscales of the PROMIS Global Health and the VR-12. The mean VR-12 physical component and mental component scores were 45.2 and 46.6, respectively; the mean PROMIS physical and mental health scores were 48.3 and 48.5, respectively. We found evidence that the combined set of VR-12 and PROMIS items were relatively unidimensional and that we could proceed with linking. Linking worked better between the physical health than mental health scores using VR-12 item responses (vs. linking based on algorithmic scores). For each of the cross-walks, users can minimize the impact of linking error with modest increases in sample sizes. VR-12 scores can be expressed on the PROMIS Global Health metric to facilitate the evaluation of treatment, including CER. Extending these results to other common measures of global health is encouraged.

When do patient‐reported outcome measures inform readmission risk?

To characterize changes in patient-reported outcome measures from hospital discharge to assess when they best inform risk of utilization as defined by readmissions or emergency department use. Patients discharged from an urban safety-net hospital. Longitudinal cohort study. We serially administered the Memorial Symptom Assessment Scale (MSAS) and the PROMIS Global Health short form assessing General Self-Rated Health (GSRH), Global Physical (GPH), and Mental (GMH) Health at 0, 30, 90, and 180 days from hospital discharge. Time to first utilization from each survey was plotted by dichotomizing our sample on each patient-reported measure, and equivalence of the time-to-event curves was assessed using the log-rank test. Cox proportional hazard models were used to control for available covariates including prior utilization during the study, Charlson score, age, gender, and race/ethnicity. We assessed each measure's effect on the fit of the predictive models using the likelihood ratio test. We recruited 196 patients, of whom 100%, 98%, 90%, and 88% completed each respective survey wave. Participants' mean age was 52 years, 51% were women, 60% were non-Hispanic black, and 21% completed the questionnaires in Spanish. In-hospital assessments revealed high symptom burden and poor health status. In-hospital assessments of GMH and GSRH predicted 14-day reutilization, whereas posthospitalization assessments of MSAS and GPH predicted subsequent utilizations. Each measure selectively improved predictive model fit. Routine measurement of patient-reported outcomes can help identify patients at higher risk for utilizations. At different time points, MSAS, GPH, GMH, and GSRH all informed utilization risk.

Development and validation of the functional assessment of cancer therapy-antiangiogenesis subscale.

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.

HD-PRO-TRIAD™ Validation: A Patient-reported Instrument for the Symptom Triad of Huntington's Disease.

BackgroundFew valid, disease-specific measures of health-related quality of life (HRQOL) capture the spectrum of symptoms associated with Huntington's disease (HD). The HD-PRO-TRIAD™ is a new, HD-specific, patient-reported outcome (PRO) instrument of the HD symptom triad (cognitive decline, emotional/behavioral dyscontrol, and motor dysfunction) designed for clinical research and practice. The objective was to validate the HD-PRO-TRIAD™ through a cross-sectional sample of individuals with HD and caregivers.MethodsDevelopment of the HD-PRO-TRIAD™ has been described elsewhere. A total of 132 individuals with HD and 40 HD caregivers, comprising 29 dyads, participated in the cross-sectional psychometric validation of this instrument. Participants provided responses to the HD-PRO-TRIAD™ and other HRQOL and disease severity instruments (EuroQOL 5D, Short Form 12, Neuro-QOL Item Banks, PROMIS Global Health, and self-reported Unified Huntington's Disease Rating Scale Total Functional Capacity and Independence Scales). Internal consistency, construct validity, and patient–caregiver proxy consistency were evaluated.ResultsInternal consistency of the three domains and overall HD-PRO-TRIAD™ instrument was supported by Cronbach's alpha values ≥0.94. Construct validity was supported by significant correlations between HD-PRO-TRIAD™ domain scores and other measures of the same domains (e.g., significant positive correlations between HD-PRO-TRIAD™ Anxiety with Neuro-QOL Anxiety), as well as slightly weaker but still strong correlations with other HRQOL instruments (e.g., HD-PRO-TRIAD™ Anxiety and UHDRS Independence; all p<0.01). Consistency between patient self-report and caregiver proxy report was supported by an intra-class correlation coefficient ≥0.92 for all three domains and the overall instrument.DiscussionThese data indicate that HD-PRO-TRIAD™ is a reliable and valid HRQOL instrument that captures the typical triad of HD symptoms.