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Objective: To estimate the contributions of health-related quality of life domains to the patient global assessment of disease activity (PtGA) in rheumatoid arthritis (RA)., Methods: Data are drawn from baseline visits of 2 observational RA cohorts. Participants completed forms for patient-reported outcome measures, including PtGA and measures from the Patient-Reported Outcomes Measurement Information System, and clinical data were collected. Factor analysis was used to identify latent variables, and multivariable linear regression was used to estimate determinants of the PtGA., Results: Patients were mostly female (81%), white (78%), and had established disease (mean ± SD 12.3 ± 10.7 years), with 62% in remission or having low disease activity. In cohort 1 (n = 196), the following 2 factors emerged: 1) daily function (moderate-to-strong [i.e., >|0.65|] loadings of physical function, pain interference, social participation, and fatigue, and weak [>0.35] loadings of sleep disturbance); and 2) emotional distress (strong loadings of depression and anxiety). In crude analysis, daily function explained up to 53% and emotional distress up to 20% of the variance in PtGA. In both cohorts, in adjusted analyses, daily function and, to a much lesser extent, swollen joint count independently predicted PtGA; age was inversely related to PtGA in cohort 1 only., Conclusion: These findings suggest that in patients with RA, PtGA ratings largely reflect the extent to which patients feel they can function in everyday roles and are not impacted by mood. This suggests that higher than expected PtGA scores may offer an opportunity to discuss patient expectations regarding roles and activities and the impact of their RA symptoms on daily function., (© 2020, American College of Rheumatology.)

Objectives: We explored the burden of symptoms of anxiety and depression on health-related quality of life (HRQL) in patients with rheumatoid arthritis (RA)., Methods: Adults with RA participating in an observational cohort completed PROMIS tests of depression, anxiety, fatigue, physical function (PF), pain interference (PI), sleep disturbance, and participation in social roles and activities at the baseline visit. Clinical measures of disease status were also obtained. We used ANOVA and partial correlation adjusting for the swollen joint count (SJC) to examine associations of anxiety and depression with other aspects of HRQL. Mild and moderate-severe anxiety were defined as T-scores ≥55.4 and ≥ 62.3 and mild and moderate-severe depression was defined as ≥52.5 and ≥58.6 based on previous validated clinical thresholds. Multivariable linear regression (MVR) was used to identify predictors of emotional distress with a subset analysis of those in remission/low disease activity., Results: Of 196 RA participants, 18% had mild anxiety, 9% had moderate-severe anxiety, 18% had mild depression, and 14% had moderate-severe depression symptoms. Anxiety and depression scores were associated with significantly worse mean scores across HRQL domains (p <0.05). In MVR, depression (β=0.75, p<0.001), PF (β=0.14, p=0.024) and fatigue (β=0.15, p=0.015) predicted higher anxiety levels, whereas only anxiety predicted higher depression levels (β=0.70, p=<0.001). In subset analysis, PF no longer predicted higher anxiety levels., Conclusions: Emotional distress is common in RA, even when disease is well controlled, with considerable impacts on other aspects of HRQL even at mild levels.

Objective: Nonadherence to medications is common in rheumatic conditions and associated with increased morbidity. Heterogeneous outcome reporting by researchers compromises the synthesis of evidence of interventions targeting adherence. We aimed to assess the scope of outcomes in interventional studies of medication adherence., Methods: We searched electronic databases to February 2019 for published randomized controlled trials and observational studies of interventions with the primary outcome of medication adherence including adults with any rheumatic condition, written in English. We extracted and analyzed all outcome domains and adherence measures with prespecified extraction and analysis protocols., Results: Overall, 53 studies reported 71 outcome domains classified into adherence (1 domain), health outcomes (38 domains), and adherence-related factors (e.g., medication knowledge; 32 domains). We subdivided adherence into 3 phases: initiation (n = 13 studies, 25%), implementation (n = 32, 60%), persistence (n = 27, 51%), and phase unclear (n = 20, 38%). Thirty-seven different instruments reported adherence in 115 unique ways (this includes different adherence definitions and calculations, metric, and method of aggregation). Forty-one studies (77%) reported health outcomes. The most frequently reported were medication adverse events (n = 24, 45%), disease activity (n = 11, 21%), bone turnover markers/physical function/quality of life (each n = 10, 19%). Thirty-three studies (62%) reported adherence-related factors. The most frequently reported were medication beliefs (n = 8, 15%), illness perception/medication satisfaction/satisfaction with medication information (each n = 5, 9%), condition knowledge/medication knowledge/trust in doctor (each n = 3, 6%)., Conclusion: The outcome domains and adherence measures in interventional studies targeting adherence are heterogeneous. Consensus on relevant outcomes will improve the comparison of different strategies to support medication adherence in rheumatology.

Objective: The Patient-Reported Outcomes Measurement Information System (PROMIS) aims to address the lack of generalizable and universal measure of patient-reported outcomes to assess health-related quality of life. It has not been validated for patients with chronic kidney disease. We aim to validate the PROMIS-57 and PROMIS-29 questionnaires among kidney transplant recipients., Methods: A cross-sectional sample of stable kidney transplant recipients was recruited. Each participant completed PROMIS-57, a 57-question instrument covering seven domains-physical function, anxiety, depression, fatigue, pain, sleep disturbance, and social functioning-alongside validated legacy questionnaires [Patient Health Questionnaire (PHQ9), General Anxiety Disorder (GAD7), Edmonton Symptom Assessment Scale revised (ESASr), and Kidney Disease Quality of Life (KDQoL-36)]. PROMIS-29, a 29-question instrument, is nested within PROMIS-57 and measures the same domains. Structural validity of PROMIS was assessed with confirmatory factor analysis, reported using the Comparative Fit Index (CFI). Construct validity was assessed with known-groups comparisons. Internal consistency was evaluated with Cronbach's α and convergent validity was assessed with Spearman's Rho. Test-retest reliability was assessed through the intraclass correlation coefficient (ICC)., Results: Mean (± SD) age of the 177 participants was 50 (± 17), 57% were male and 55% Caucasian. Internal consistency of each domain was high (Cronbach's α > 0.88). Confirmatory factor analysis showed good structural validity for most domains (CFI > 0.95, RMSEA < 0.05). Test-retest reliability indicated good agreement (ICC > 0.6). Known-groups comparisons by clinical and socio-demographic differences were found as hypothesized., Conclusions: Our results provide evidence that PROMIS-57 and PROMIS-29 are highly reliable and valid instruments among kidney transplant recipients. We propose it as a valuable tool to assess important domains of the illness experience.

Background: We outline different health outcomes and describe how multiple perspectives can be harnessed to optimize accuracy of key data collected about patients with chronic conditions. The terms health status, health-related quality of life, and quality of life are often used interchangeably without recognizing that they have different meanings, as are the terms used to refer to the different components of function. Although the advantages and limitations of existing frameworks and perspectives are largely understood, greater precision is needed when using health outcome terminology and identifying optimal sources of information., Objective: A refinement of the current taxonomy is proposed to distinguish between patient-reported outcomes and self-report outcomes and expand the concept of clinically reported outcomes to include those assessed by performance and emerging technologies., Discussion: Health outcomes yield important information that can be used to improve the lives of many people. Now is the time to "talk the talk" as part of larger coordinated efforts within and across countries to identify and measure what matters most in health., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objective: To describe the practical steps in identifying items and evaluating scoring strategies for a new measure of emotional vitality in informal caregivers of individuals who have experienced a significant health event., Design: The psychometric properties of responses to selected items from validated health-related quality of life and other psychosocial questionnaires administered four times over a one-year period were evaluated using Rasch Measurement Theory., Setting: Community., Subjects: A total of 409 individuals providing informal care at home to older adults who had experienced a recent stroke., Main Measures: Rasch Measurement Theory was used to test the ordering of response option thresholds, fit, spread of the item locations, residual correlations, person separation index, and stability across time., Results: Based on a theoretical framework developed in earlier work, we identified 22 candidate items from a pool of relevant psychosocial measures available. Of these, additional evaluation resulted in 19 items that could be used to assess the five core domains. The overall model fit was reasonable (χ(2) = 202.26, DF = 117, p = 0.06), stable across time, with borderline evidence of multidimensionality (10%). Items and people covered a continuum ranging from -3.7 to +2.7 logits, reflecting coverage of the measurement continuum, with a person separation index of 0.85. Mean fit of caregivers was lower than expected (-1.31 ±1.10 logits)., Conclusion: Established methods from the Rasch Measurement Theory were applied to develop a prototype measure of emotional vitality that is acceptable, reliable, and can be used to obtain an interval level score for use in future research and clinical settings., (© The Author(s) 2014.)

Objective: To evaluate the effect of Integral-based hatha yoga in sedentary people with arthritis., Methods: There were 75 sedentary adults aged 18+ years with rheumatoid arthritis (RA) or knee osteoarthritis randomly assigned to 8 weeks of yoga (two 60-min classes and 1 home practice/wk) or waitlist. Poses were modified for individual needs. The primary endpoint was physical health [Medical Outcomes Study Short Form-36 (SF-36) physical component summary (PCS)] adjusted for baseline; exploratory adjusted outcomes included fitness, mood, stress, self-efficacy, SF-36 health-related quality of life (HRQOL), and RA disease activity. In everyone completing yoga, we explored longterm effects at 9 months., Results: Participants were mostly female (96%), white (55%), and college-educated (51%), with a mean (SD) age of 52 years (12 yrs). Average disease duration was 9 years and 49% had RA. At 8 weeks, yoga was associated with significantly higher PCS (6.5, 95% CI 2.0-10.7), walking capacity (125 m, 95% CI 15-235), positive affect (5.2, 95% CI 1.4-8.9), and lower Center for Epidemiologic Studies Depression Scale (-3.0, 95% CI -4.8 - -1.3). Significant improvements (p < 0.05) were evident in SF-36 role physical, pain, general health, vitality, and mental health scales. Balance, grip strength, and flexibility were similar between groups. Twenty-two out of 28 in the waitlist group completed yoga. Among all yoga participants, significant (p < 0.05) improvements were observed in mean PCS, flexibility, 6-min walk, and all psychological and most HRQOL domains at 8 weeks with most still evident 9 months later. Of 7 adverse events, none were associated with yoga., Conclusion: Preliminary evidence suggests yoga may help sedentary individuals with arthritis safely increase physical activity, and improve physical and psychological health and HRQOL. Clinical Trials NCT00349869.

Purpose: Emotional vitality may play an important role in determining whether informal caregivers are able to successfully adopt and persist in their roles. This study describes a content validation of a conceptual model of emotional vitality in informal caregivers., Methods: A secondary content analysis was performed on transcripts of 30 caregivers who were interviewed about their quality of life in relation to assuming the role of informal caregiver for a family member who had experienced a recent stroke. Caregivers discussed changes in their own health, relationships, roles, finances, participation, and mood after assuming the caregiving role. Using a thematic inductive approach, two raters independently coded the presence and frequency of physical, emotional, and social impacts associated with the caregiving role in order to further develop and validate a conceptual model of caregiver emotional vitality., Results: The interviews provided information that affirmed the relevance of four themes relevant to caregiver emotional vitality previously identified: physical health and well-being; mood regulation; sense of control/mastery of new skills; and participation in meaningful activity. An additional theme of support and recognition from others also emerged., Conclusions: Adopting the informal caregiving role results in major impacts to the caregiver's physical, emotional, and social health. Five core domains appear to meaningfully contribute to emotional vitality of caregivers and may influence their ability to persist in this role over time. Many of the factors that influence emotional vitality in caregivers are potentially modifiable. This new model offers new opportunities for rehabilitation specialists and allied health professionals to develop skill-building interventions that may help caregivers successfully adapt and thrive in the caregiving role.

Systemic sclerosis (SSc), or scleroderma, is a chronic multisystem autoimmune disorder characterised by thickening and fibrosis of the skin and by the involvement of internal organs such as the lungs, kidneys, gastrointestinal tract, and heart. Because there is no cure, feasibly-implemented and easily accessible evidence-based interventions to improve health-related quality of life (HRQoL) are needed. Due to a lack of evidence, however, specific recommendations have not been made regarding non-pharmacological interventions (e.g. behavioural/psychological, educational, physical/occupational therapy) to improve HRQoL in SSc. The Scleroderma Patient-centred Intervention Network (SPIN) was recently organised to address this gap. SPIN is comprised of patient representatives, clinicians, and researchers from Canada, the USA, and Europe. The goal of SPIN, as described in this article, is to develop, test, and disseminate a set of accessible interventions designed to complement standard care in order to improve HRQoL outcomes in SSc.

Background: Asthma is a prevalent and costly disease resulting in reduced quality of life for a large proportion of individuals. Effective patient self-management is critical for improving health outcomes. However, key aspects of self-management such as self-monitoring of behaviours and symptoms, coupled with regular feedback from the health care team, are rarely addressed or integrated into ongoing care. Health information technology (HIT) provides unique opportunities to facilitate this by providing a means for two way communication and exchange of information between the patient and care team, and access to their health information, presented in personalized ways that can alert them when there is a need for action. The objective of this study is to evaluate the acceptability and efficacy of using a web-based self-management system, My Asthma Portal (MAP), linked to a case-management system on asthma control, and asthma health-related quality of life., Methods: The trial is a parallel multi-centered 2-arm pilot randomized controlled trial. Participants are randomly assigned to one of two conditions: a) MAP and usual care; or b) usual care alone. Individuals will be included if they are between 18 and 70, have a confirmed asthma diagnosis, and their asthma is classified as not well controlled by their physician. Asthma control will be evaluated by calculating the amount of fast acting beta agonists recorded as dispensed in the provincial drug database, and asthma quality of life using the Mini Asthma Related Quality of Life Questionnaire. Power calculations indicated a needed total sample size of 80 subjects. Data are collected at baseline, 3, 6, and 9 months post randomization. Recruitment started in March 2010 and the inclusion of patients in the trial in June 2010., Discussion: Self-management support from the care team is critical for improving chronic disease outcomes. Given the high volume of patients and time constraints during clinical visits, primary care physicians have limited time to teach and reinforce use of proven self-management strategies. HIT has the potential to provide clinicians and a large number of patients with tools to support health behaviour change., Trial Registration: Current Controlled Trials ISRCTN34326236.

Background: More than 40% of people born with cystic fibrosis (CF) now reach adulthood. Greater attention is being focused on improving their health-related quality of life (HRQoL). While markers of disease severity such as lung function are only modestly associated with HRQoL, in other chronic illnesses depression is an important correlate. The objective of this study was to evaluate the relationships among lung function (ie, FEV(1) percent predicted), depressive symptoms, and HRQoL among adults with CF., Methods: Seventy-six adults with CF completed a mail-based survey. The Beck Depression Inventory and the Cystic Fibrosis Questionnaire were used to assess depressive symptoms and HRQoL, respectively. Values for FEV(1) percent predicted were abstracted from the medical record., Results: Thirty percent of participants screened positive for depressive symptoms. Depressive symptoms and lung function were inversely correlated (rho = -0.25; p < .05). Correlations between depressive symptoms and HRQoL were maintained after stratifying by lung function. In the absence of depressive symptoms, those patients with good lung function (ie, FEV(1), > 70% predicted) reported better physical HRQoL than those with poor lung function. Participants with both depressive symptoms and poor lung function reported significantly worse HRQoL on all domains than participants without depressive symptoms regardless of lung function status., Conclusions: Depressive symptoms are prevalent among adults with CF and are associated with poorer HRQoL even after controlling for lung function. These results suggest that screening for and treating depression is important and may potentially improve HRQoL among patients with CF.

To evaluate the 1-year results of treatment-induced weight loss on health-related quality of life (HRQL), 32 mildly to moderately overweight persons who participated in a 13-week weight loss program completed the Medical Outcomes Study Short Form-36 Health Survey (SF-36) at baseline, immediately after the program, and at 1-year follow-up. At 1 year, 65.6% of participants maintained at least some weight loss. The improvements on HRQL observed immediately after treatment on the physical functioning, role-physical, general health, vitality, and mental health scales of the SF-36 were maintained only on the general health and vitality scales at 1 year. There were no significant differences between weight maintainers and weight regainers on change from baseline to 1-year follow-up on HRQL. Our findings suggest that treatment-induced weight loss among mildly to moderately overweight persons improves HRQL and that at least some of these benefits are maintained at 1-year follow-up regardless of whether the weight loss is maintained.

Objective: To evaluate spirituality, well-being, and quality of life (QOL) among people with rheumatoid arthritis (RA)., Methods: Questionnaires assessing positive and negative affect, depression, QOL and spirituality were completed. Disease activity was assessed by rheumatologic examination., Results: Women (n = 62) had a mean (+/- SD) age of 53.0 (+/- 13.0) years with 12 (+/- 13) swollen and tender joints (STJ). Men (n = 15) were 61.9 (+/- 13.0) years with 7 (+/- 11) STJ. Disease activity was associated (P < 0.05) positively with depression (r = 0.23), pain (r = 0.26), poorer self-ratings of health (r = 0.29) and physical role limitations (r = 0.26). Spirituality was associated directly with positive affect (r = 0.26) and higher health perceptions (r = 0.29). In multiple regression, spirituality was an independent predictor of happiness and positive health perceptions, even after controlling disease activity and physical functioning, for age and mood., Conclusion: Spirituality may facilitate emotional adjustment and resilience in people with RA by experiencing more positive feelings and attending to positive elements of their lives.

Objective. The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 assesses seven health-related quality of life domains plus pain intensity. The objective was to examine PROMIS- 29v2 validity and explore clinical associations in patients with SSc. Methods. English-speaking SSc patients in the Scleroderma Patient-centered Intervention Network Cohort from 26 sites in Canada, the USA and the UK completed the PROMIS-29v2 between July 2014 and November 2015. Enrolling physicians provided medical data. To examine convergent validity, hypotheses on the direction and magnitude of correlations with legacy measures were tested. For clinical associations, t-tests were conducted for dichotomous variables and PROMIS-29v2 domain scores. Effect sizes (ESs) were labelled as small (<0.25), small to moderate (<0.25-0.45), moderate (0.46-0.55), moderate to large (0.56-0.75) and large (>0.75). Results. There were 696 patients (87% female), mean (S.D.) disease duration 11.6 (8.7) years, 57% with limited cutaneous subtype. Validity indices were consistent with seven of nine hypotheses (//r// =0.51-0.87, P<0.001), with minor divergence for two hypotheses. Gastrointestinal involvement was associated with significantly worse outcomes for all eight PROMIS-29v2 domains (moderate or moderate to large ES in six of eight). Presence of joint contractures was associated with significant decrements in seven domains (small or small to moderate ESs). Skin thickening, diffuse cutaneous subtype and presence of overlap syndromes were significantly associated (small or small to moderate ESs) with five or six domains. Conclusion. This study further establishes the validity of the PROMIS-29v2 in SSc and underlines the importance of gastrointestinal symptoms and joint contractures in reduced health-related quality of life. [ABSTRACT FROM AUTHOR]

Purpose: The field of patient-centered outcomes research (PCOR) continues to develop. Patient-reported outcomes and, in particular the Patient-Reported Outcomes Measurement Information System (PROMIS) contribute complementary data to clinician-derived outcomes traditionally used in health decision-making. However, there has been little work to understand how PROMIS measures may inform or be integrated into PCOR or clinical applications.Methods: Lead investigators from four pilot projects funded by the Patient-Centered Outcomes Research Institute (PCORI) collaborated to discuss lessons learned about the use of PROMIS in PCOR studies via virtual and in-person meetings. In addition, a qualitative data collection tool was used to assess the pilot projects' experiences.Results: Lessons learned from the pilot projects centered on practical elements of research design, such as choosing the right outcomes to study, considering the advantages and limitations of the PROMIS short forms and computer adaptive technology versions, planning ahead for a feasible data collection process, maintaining the focus on patients by ensuring that the research is truly patient-centered, and helping patients and providers make the most of PROMIS in care.Conclusion: The PCORI pilot projects demonstrated that PROMIS can be successfully used to conduct research that will help patients make decisions about their care. Interest in PCOR continues to grow and the lessons learned from these projects about the use of PROMIS will be helpful to investigators. Given the numerous benefits of PROMIS, implementing this tool in research and care will hopefully lead to significant progress in measuring health outcomes that are meaningful and relevant to all stakeholders. [ABSTRACT FROM AUTHOR]

Background: Little is known about how drug presentation influences medication adherence. Objective: To examine the effect of an educational program aimed at increasing expectations of treatment benefit on medication adherence. Methods: Data are analyzed from 99 participants who underwent electronic drug monitoring during the Trial of Asthma Patient Education, a randomized, placebo-controlled, multicenter trial. Participants with suboptimally controlled asthma were randomized to placebo or montelukast in conjunction with a presentation mode that was either neutral or designed to increase outcome expectancy. Adherence was monitored electronically over 4 weeks and was defined as ≥80% use of prescribed doses. Outcome expectancy, peak expiratory flow, prebronchodilator FEV1, asthma control (Juniper asthma control questionnaire), and asthma-related quality of life were assessed at baseline and at the 4-week follow-up. Results: Average electronic medication adherence was 69.9%. There was a significant interaction between presentation mode and drug assignment, with participants in the enhanced/montelukast group having a higher change in outcome expectancy (Δ 2.1 points; P < .001) and better medication adherence (odds ratio, 4.0; 95% CI, 1.1-14.3) compared with those in the neutral/placebo group. There was no difference in asthma symptoms, quality of life, or clinical outcomes on the basis of presentation mode. Rather, increased outcome expectancy was associated with modest improvements in asthma symptoms after adjusting for presentation mode, drug assignment, and medication adherence. Conclusion: The use of an enhanced presentation aimed at increasing outcome expectancy may lead to improved medication adherence. [ABSTRACT FROM AUTHOR]

Objective: To examine the validity and reliability of the PROMIS Sleep Disturbance Item Bank Computer Adaptive Test (PROMIS-SD CAT) in patients on renal replacement therapy, using the Insomnia Severity Index as the primary legacy instrument.Methods: Cross-sectional sample of adults on renal replacement therapy completed PROMIS-SD CAT, Insomnia Severity Index, General Anxiety Disorder-7, Edmonton Symptom Assessment System-revised Renal, SF-12 questionnaires. Construct validity was confirmed by associations with legacy instrument scores and measures of emotional wellbeing. Test-retest and scale reliability were assessed using intraclass correlation coefficient and standard errors of measurement, respectively. Discrimination was assessed using receiver-operating characteristic curve analysis.Results: Among 217 participants (133 kidney transplant recipients, 84 on dialysis), 15% had moderate/severe sleep disturbance (Insomnia Severity Index ≥15). PROMIS-SD CAT exhibited good test-retest (intraclass correlation coefficient = 0.89, 95% confidence interval (0.83-0.93)) and scale (>0.9 for T-scores 34-73) reliability. PROMIS-SD CAT T-scores were strongly correlated with Insomnia Severity Index (rho = 0.85, 95% confidence interval (0.81-0.88)), Edmonton Symptom Assessment System-revised Renal Sleep Item (rho = 0.75, 95% confidence interval (0.69-0.81)) and moderately with General Anxiety Disorder-7 scores and SF-12 Mental Component Summary scores (p < 0.001 for all). PROMIS-SD CAT demonstrated outstanding discrimination for moderate/severe insomnia (defined as Insomnia Severity Index ≥15) (AUROC 0.93, 95% confidence interval (0.88, 0.98)). PROMIS-SD CAT and Insomnia Severity Index measurement characteristics were qualitatively similar between patients on dialysis and kidney transplant recipients.Conclusions: These results support PROMIS-SD CAT's validity and reliability for research and as potential screening tool among patients on renal replacement therapy. [ABSTRACT FROM AUTHOR]