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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 (χ2 = 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. [ABSTRACT FROM AUTHOR]

Yoga is a popular activity which may be well suited to some individuals with specific rheumatic disorders. Regular yoga practice can increase muscle strength and endurance, proprioception, and balance, with emphasis on movement through a full range of motion to increase flexibility and mobility. Additional beneficial elements of yoga include breathing, relaxation, body awareness, and meditation, which can reduce stress and anxiety and promote a sense of calmness, general well-being, and improved quality of life. Yoga also encourages a meditative focus, increased body awareness and mindfulness; some evidence suggests yoga may help reduce inflammatory mediators including C-reactive protein and interleukin-6. Yoga is best learned under the supervision of qualified teachers who are well informed about the potential musculoskeletal needs of each individual. Here, we briefly review the literature on yoga for healthy, musculoskeletal, and rheumatic disease populations and offer recommendations for discussing ways to begin yoga with patients. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: To (1) provide a framework for the conceptualization of emotional vitality as an important construct for rehabilitation professionals; (2) outline the existing scope and breadth of knowledge currently available regarding the definition and measurement of emotional vitality in persons with chronic health conditions; and (3) identify the extent to which the components can be mapped to the International Classification of Functioning, Disability and Health (ICF). Design: Activities included a scoping review of the literature, and a Delphi mapping exercise using the ICF. Setting: Not applicable. Participants: Not applicable. Intervention: Not applicable. Main Outcome Measure: Not applicable. Results: The results of this study suggest that emotional vitality is a complex latent construct that includes (1) physical energy and well-being, (2) regulation of mood, (3) mastery, and (4) engagement and interest in life. Existing literature supported the presence of all 4 components of the construct. The mapping exercise showed that 3 of these components could be readily mapped to the Body Function chapter of the ICF (energy, mood, mastery). Conclusions: Emotional vitality may influence both the physical and emotional adaptation to living with a chronic illness or disability and should be included in both assessment and treatment planning to optimize rehabilitation outcomes. Future research is needed to refine the definition and identify optimal methods of measuring this construct. [Copyright &y& Elsevier]

Introduction: Psychosocial and rehabilitation interventions are increasingly used to attenuate disability and improve health-related quality of life (HRQL) in chronic diseases, but are typically not available for patients with rare diseases. Conducting rigorous, adequately powered trials of these interventions for patients with rare diseases is difficult. The Scleroderma Patient-centered Intervention Network (SPIN) is an international collaboration of patient organisations, clinicians and researchers. The aim of SPIN is to develop a research infrastructure to test accessible, low-cost self-guided online interventions to reduce disability and improve HRQL for people living with the rare disease systemic sclerosis (SSc or scleroderma). Once tested, effective interventions will be made accessible through patient organisations partnering with SPIN. Methods and analysis: SPIN will employ the cohort multiple randomised controlled trial (cmRCT) design, in which patients consent to participate in a cohort for ongoing data collection. The aim is to recruit 1500-2000 patients from centres across the world within a period of 5 years (2013-2018). Eligible participants are persons ≥18 years of age with a diagnosis of SSc. In addition to baseline medical data, participants will complete patient-reported outcome measures every 3 months. Upon enrolment in the cohort, patients will consent to be contacted in the future to participate in intervention research and to allow their data to be used for comparison purposes for interventions tested with other cohort participants. Once interventions are developed, patients from the cohort will be randomly selected and offered interventions as part of pragmatic RCTs. Outcomes from patients offered interventions will be compared with outcomes from trial-eligible patients who are not offered the interventions. The use of the cmRCT Ethics and dissemination: design, the development of self-guided online interventions and partnerships with patient organisations will allow SPIN to develop, rigourously test and effectively disseminate psychosocial and rehabilitation interventions for people with SSc. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is Available in the Text. Background: Low-risk perception is an important barrier to the utilization of HIV services. In this context, offering an online platform for people to assess their risk of HIV and inform their decision to test can be impactful in increasing testing uptake. Using secondary data from the HIVSmart! quasirandomized trial, we aimed to identify predictors of HIV, develop a risk staging model for South African township populations, and validate it in combination with the HIVSmart! digital self-testing program. Setting: Townships in Cape Town, South Africa. Methods: Using Bayesian predictive projection, we identified predictors of HIV and constructed a risk assessment model that we validated in external data. Results: Our analyses included 3095 participants from the HIVSmart! trial. We identified a model of 5 predictors (being unmarried, HIV testing history, having had sex with a partner living with HIV, dwelling situation, and education) that performed best during external validation (area under the receiver operating characteristic curve, 89% credible intervals: 0.71, 0.68 to 0.72). The sensitivity of our HIV risk staging model was 91.0% (89.1% to 92.7%) and the specificity was 13.2% (8.5% to 19.8%) but increased when combined with a digital HIV self-testing program, the specificity was 91.6% (95.9% to 96.4%) and sensitivity remained similar at 90.9% (89.1% to 92.6%). Conclusions: This is the first validated digital HIV risk assessment tool developed for South African township populations and the first study to evaluate the added value of a risk assessment tool with an app-based HIV self-testing program. Study findings are relevant for application of digital programs to improve utilization of HIV testing services. [ABSTRACT FROM AUTHOR]

Patient-reported outcomes (PROs) play an increasingly important role in clinical practice and research. Modern psychometric methods such as item response theory (IRT) enable the creation of item banks that support fixed-length forms as well as computerized adaptive testing (CAT), often resulting in improved measurement precision and responsiveness. Here we describe and discuss the case for developing an international core set of PROs building from the US PROMIS® network. PROMIS is a U.S.-based cooperative group of research sites and centers of excellence convened to develop and standardize PRO measures across studies and settings. If extended to a global collaboration, PROMIS has the potential to transform PRO measurement by creating a shared, unifying terminology and metric for reporting of common symptoms and functional life domains. Extending a common set of standardized PRO measures to the international community offers great potential for improving patient-centered research, clinical trials reporting, population monitoring, and health care worldwide. Benefits of such standardization include the possibility of: international syntheses (such as meta-analyses) of research findings; international population monitoring and policy development; health services administrators and planners access to relevant information on the populations they serve; better assessment and monitoring of patients by providers; and improved shared decision making. The goal of the current PROMIS International initiative is to ensure that item banks are translated and culturally adapted for use in adults and children in as many countries as possible. The process includes 3 key steps: translation/cultural adaptation, calibration, and validation. A universal translation, an approach focusing on commonalities, rather than differences across versions developed in regions or countries speaking the same language, is proposed to ensure conceptual equivalence for all items. International item calibration using nationally representative samples of adults and children within countries is essential to demonstrate that all items possess expected strong measurement properties. Finally, it is important to demonstrate that the PROMIS measures are valid, reliable and responsive to change when used in an international context. IRT item banking will allow for tailoring within countries and facilitate growth and evolution of PROs through contributions from the international measurement community. A number of opportunities and challenges of international development of PROs item banks are discussed. [ABSTRACT FROM AUTHOR]

Objectives For rheumatoid arthritis (RA), there is no consensus on how to define and assess flare. Variability in flare definitions impairs understanding of findings across studies and limits ability to pool results. The OMERACT RA Flare Group sought to identify domains to define RA flares from patient and healthcare professional (HCP) perspectives. Methods Flare was described as a worsening of disease activity of sufficient intensity and duration to consider a change in therapy. International patients and HCPs participated in separate and combined rounds of Delphi exercises to rate candidate flare domains previously generated in patient focus groups. Core domains were defined as those with =70% ratings of being 'essential' according to the third/final Delphi exercise. Results The final Delphi included 125 RA patients from 10 countries and 108 HCPs from 23 countries who rated 14 domains. Patients had a mean (±SD) age of 56±12 years and disease duration of 18±12 years. HCPs included physicians from clinical practice/research and industry, allied health providers and researchers with 17±11 years experience. Core domains comprised: pain (93%), function (89%), swollen joints (84%), tender joints (81%), participation (81%), stiffness (79%), patient global assessment (76%) and self-management (75%). Fatigue (68%), which did not reach group consensus, will receive additional consideration. Conclusions As part of the process to develop a measure for RA flare, patients and HCPs agreed on eight core domains. Next steps include identifying items to assess domains and conducting studies to validate and refine a new measure. [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]

A correction to the originally published version of the article "Patient and Rheumatologist Perspectives on Tapering DMARDs in Rheumatoid Arthritis: A Qualitative Study" is presented.

Background: The use of Patient-Reported Outcome Measures (PROMs) in routine clinical care can help ensure symptoms are identified, acknowledged and addressed. In 2007, the provincial cancer agency, Cancer Care Ontario, began to implement routine symptom screening with the Edmonton Symptom Assessment System (ESAS) for ambulatory cancer patients. Having had a decade of experience with ESAS, the program developed a strategic interest in implementing new and/or additional measures. This article describes the development of a streamlined PROM selection and implementation evaluation process with core considerations. Methods: Development of the PROM selection and implementation evaluation process involved analysis of quantitative and qualitative data as well as consensus building through a multi-stakeholder workshop. Core PROM selection considerations were developed through a literature scan, review and refinement by a panel of methodological experts and patient advisors, and testing via a test case. Core PROM implementation evaluation considerations were developed through analysis of PROM evaluation frameworks, and review and refinement by a committee of provincial implementation leads. Results: Core PROM selection considerations were identified under three overarching themes: symptom coverage, usability and psychometric properties. The symptom coverage category assesses each PROM to determine how well the PROM items address the most prevalent and burdensome symptoms in the target patient population. The usability category aims to assess each measure on characteristics key to successful implementation in the clinical setting. The psychometric properties category assesses each PROM to ensure the data collected is credible, meaningful and interpretable. A scoring system was developed to rate PROM performance by assigning a grade of "weak", "average" or "good" for each category. The process results in a summary matrix which illustrates the overall assessment of each PROM. Implementation evaluation considerations were identified under three overarching concepts: acceptability, outcomes, and sustainability. A consensus building exercise resulted in the further identification of patient, provider, and clinic specific indicators for each consideration. Conclusion: To address the need for a systematic, evidence-based approach to selection, implementation and evaluation of PROMs in the clinical setting, Cancer Care Ontario defined a process with embedded core considerations to facilitate decision-making and encourage standardization. [ABSTRACT FROM AUTHOR]

Objectives This study aimed to implement a patient-centred and evidence-based approach to develop a novel patient-reported outcome (PRO) instrument to measure fatigue in patients with SLE. Methods A three-step mixed methods psychometric (MMP) approach was followed. Steps comprised first draft item generation and review using interview data; evaluation and refinement of second draft items using mixed methods data, including interview and quantitative data from a phase 2 clinical study in SLE analysed using Rasch Measurement Theory (RMT) analysis; and evaluation of the final FATIGUE-PRO items using RMT and complementary Classical Test Theory (CTT) analyses. Guided by MMP criteria, a team of clinicians and outcome-measurement experts assessed evidence to inform instrument development. Results Step 1 culminated in 55 items (n  = 39 patients interviewed). Their refinement in step 2 using mixed methods evidence led to the final FATIGUE-PRO instrument comprising 31 items across three scales of fatigue: physical fatigue (9 items), mental and cognitive fatigue (11 items) and susceptibility to fatigue (11 items). Qualitative (n  = 43 patients) and quantitative (n  = 106 patients) evidence strongly supported the scales' content comprehensiveness and targeting, item quality and fit, conceptual uniqueness and appropriateness of the response scale. The FATIGUE-PRO further benefited from excellent reliability (RMT: 0.92–0.94 and CTT: 0.95–0.96) and supportive evidence of construct validity from assessments against other PROs. Conclusion The conceptual advances, comprehensive coverage and strong psychometric properties of the FATIGUE-PRO will significantly advance the measurement and management of fatigue in SLE, both in clinical trials and routine practice. Trial registration ClinicalTrials.gov (https://clinicaltrials.gov), NCT02804763 [ABSTRACT FROM AUTHOR]

Objective Methods Results Conclusion Our objective was to characterize nonarticular pain (NAP) at early rheumatoid arthritis (RA) diagnosis, the evolution over the first year of treatment, associations with active RA inflammation, and the impact on remission.This real‐world, longitudinal multicenter cohort study observed participants with active early RA (symptoms <1 year and Clinical Disease Activity Index [CDAI] >2.8) enrolled between January 2017 and January 2022 who completed a body pain diagram over 1 year. Participants were grouped by prespecified definitions of NAP: (1) none, (2) regional, or (3) widespread. Rheumatologists performed joint counts. Descriptive statistics summarized the frequency and evolution of NAP patterns over 1 year. Chi‐square tests compared the proportions of tender and/or swollen joints by the presence of pain in each NAP section. Multiadjusted generalized estimating equations regression models estimated associations of NAP patterns with remission outcomes.Participants (N = 392) were 70% female, with a mean ± SD age of 56 ± 14 years and mean ± SD symptoms duration of 5.1 ± 2.7 months. More than half reported NAP at baseline, with most (73%) presenting with regional NAP. Common patterns of regional NAP were axial (40%) and pain in upper quadrants (17%). A total of 43% of those with regional NAP persisted or worsened over 1 year, whereas 73% of those with widespread NAP resolved or improved. Joint inflammation was more frequently reported in areas with NAP versus areas without NAP. Regional and widespread NAP were associated with lower odds of reaching CDAI remission (adjusted odds ratio 0.42, 95% confidence interval 0.26–0.70 and adjusted odds ratio 0.30, 95% confidence interval 0.12–0.74), respectively.Regional NAP is common and persistent in early RA and impacts remission. RA activity may contribute to NAP. More attention to NAP in RA care is warranted. [ABSTRACT FROM AUTHOR]

Objectives To compare physical function in systemic sclerosis (SSc, scleroderma) to general population normative data and identify associated factors. Methods Scleroderma Patient-centered Intervention Network Cohort participants completed the Physical Function domain of the Patient-Reported Outcomes Measurement Information System Version 2 upon enrolment. Multivariable linear regression was used to assess associations of sociodemographic, lifestyle, and disease-related variables. Results Among 2385 participants, the mean physical function T-score (43.7, SD = 8.9) was ∼2/3 of a standard deviation (SD) below the US general population (mean = 50, SD = 10). Factors associated in the multivariable analysis included older age (−0.74 points per SD years, 95% CI −0.78 to −1.08), female sex (−1.35, −2.37 to −0.34), fewer years of education (−0.41 points per SD in years, −0.75 to −0.07), being single, divorced, or widowed (−0.76, −1.48 to −0.03), smoking (−3.14, −4.42 to −1.85), alcohol consumption (0.79 points per SD drinks per week, 0.45–1.14), BMI (−1.41 points per SD, −1.75 to −1.07), diffuse subtype (−1.43, −2.23 to −0.62), gastrointestinal involvement (−2.58, −3.53 to −1.62), digital ulcers (−1.96, −2.94 to −0.98), moderate (−1.94, −2.94 to −0.93) and severe (−1.76, −3.24 to −0.28) small joint contractures, moderate (−2.10, −3.44 to −0.76) and severe (−2.54, −4.64 to −0.44) large joint contractures, interstitial lung disease (−1.52, −2.27 to −0.77), pulmonary arterial hypertension (−3.72, −4.91 to −2.52), rheumatoid arthritis (−2.10, −3.64 to −0.56) and idiopathic inflammatory myositis (−2.10, −3.63 to −0.56). Conclusion Physical function is impaired for many individuals with SSc and is associated with multiple disease factors. [ABSTRACT FROM AUTHOR]