Combining online and in-person methods to evaluate the content validity of PROMIS fatigue short forms in rheumatoid arthritis.

PURPOSE: Fatigue is frequent and often severe and disabling in RA, and there is no consensus on how to measure it. We used online surveys and in-person interviews to evaluate PROMIS Fatigue 7a and 8a short forms (SFs) in people with RA. METHODS: We recruited people with RA from an online patient community (n = 200) and three academic medical centers (n = 84) in the US. Participants completed both SFs then rated the comprehensiveness and comprehensibility of the items to their fatigue experience. Cognitive debriefing of items was conducted in a subset of 32 clinic patients. Descriptive statistics were calculated, and associations were evaluated using Pearson and Spearman correlation coefficients. RESULTS: Mean SF scores were similar (p ≥ .61) among clinic patients reflecting mild fatigue (i.e., 54.5-55.9), but were significantly higher (p < .001) in online participants. SF Fatigue scores correlated highly (r ≥ 0.82; p < .000) and moderately with patient assessments of disease activity (r ≥ 0.62; p = .000). Most (70-92%) reported that the items "completely" or "mostly" reflected their experience. Almost all (≥ 94%) could distinguish general fatigue from RA fatigue. Most (≥ 85%) rated individual items questions as "somewhat" or "very relevant" to their fatigue experience, averaged their fatigue over the past 7 days (58%), and rated fatigue impact versus severity (72 vs. 19%). 99% rated fatigue as an important symptom they considered when deciding how well their current treatment was controlling their RA. CONCLUSIONS: Results suggest that items in the single-score PROMIS Fatigue SFs demonstrate content validity and can adequately capture the wide range of fatigue experiences of people with RA.

Patient-reported outcomes: pathways to better health, better services, and better societies.

While the use of PROs in research is well established, many challenges lie ahead as their use is extended to other applications. There is consensus that health outcome evaluations that include PROs along with clinician-reported outcomes and administrative data are necessary to inform clinical and policy decisions. The initiatives presented in this paper underline evolving recognition that PROs play a unique role in adding the patient perspective alongside clinical (e.g., blood pressure) and organizational (e.g., admission rates) indicators for evaluating the effects of new products, selecting treatments, evaluating quality of care, and monitoring the health of the population. In this paper, we first explore the use of PRO measures to support drug approval and labeling claims. We critically evaluate the evidence and challenges associated with using PRO measures to improve healthcare delivery at individual and population levels. We further discuss the challenges associated with selecting from the abundance of measures available, opportunities afforded by agreeing on common metrics for constructs of interest, and the importance of establishing an evidence base that supports integrating PRO measures across the healthcare system to improve outcomes. We conclude that the integration of PROs as a key end point within individual patient care, healthcare organization and program performance evaluations, and population surveillance will be essential for evaluating whether increased healthcare expenditure is translating into better health outcomes.

Health Assessment Questionnaire at One Year Predicts All-Cause Mortality in Patients With Early Rheumatoid Arthritis.

OBJECTIVE: Higher self-reported disability (high Health Assessment Questionnaire [HAQ] score) has been associated with hospitalizations and mortality in established rheumatoid arthritis (RA), but associations in early RA are unknown. METHODS: Patients with early RA (symptom duration <1 year) enrolled in the Canadian Early Arthritis Cohort who initiated disease-modifying antirheumatic drugs and had completed HAQ data at baseline and 1 year were included in the study. Discrete-time proportional hazards models were used to estimate crude and multi-adjusted associations of baseline HAQ and HAQ at 1 year with all-cause mortality in each year of follow-up. RESULTS: A total of 1,724 patients with early RA were included. The mean age was 55 years, and 72% were women. Over 10 years, 62 deaths (3.6%) were recorded. Deceased patients had higher HAQ scores at baseline (mean ± SD 1.2 ± 0.7) and at 1 year (0.9 ± 0.7) than living patients (1.0 ± 0.7 and 0.5 ± 0.6, respectively; P < 0.001). Disease Activity Score in 28 joints (DAS28) was higher in deceased versus living patients at baseline (mean ± SD 5.4 ± 1.3 versus 4.9 ± 1.4) and at 1 year (mean ± SD 3.6 ± 1.4 versus 2.8 ± 1.4) (P < 0.001). Older age, male sex, lower education level, smoking, more comorbidities, higher baseline DAS28, and glucocorticoid use were associated with mortality. Contrary to HAQ score at baseline, the association between all-cause mortality and HAQ score at 1 year remained significant even after adjustment for confounders. For baseline HAQ score, the unadjusted hazard ratio (HR) was 1.46 (95% confidence interval [95% CI] 1.02-2.09), and the adjusted HR was 1.25 (95% CI 0.81-1.94). For HAQ score at 1 year, the unadjusted HR was 2.58 (95% CI 1.78-3.72), and the adjusted HR was 1.75 (95% CI 1.10-2.77). CONCLUSION: Our findings indicate that higher HAQ score and DAS28 at 1 year are significantly associated with all-cause mortality in a large early RA cohort.

Relationships among vitamin D, disease activity, pain and disability in rheumatoid arthritis.

BACKGROUND AND OBJECTIVES: Vitamin D is a steroid hormone with important skeletal and non-skeletal biologic functions. Vitamin D deficiency is common and manifests with musculoskeletal symptoms. In rheumatoid arthritis (RA), vitamin D deficiency may be associated with increased disease activity and disability. We aimed to estimate the relationship between Vitamin D level and disease activity, pain, and disability in RA. METHODS: Data were drawn from 62 RA patients seen in an academic arthritis clinic. 25(OH)D levels were evaluated along with markers of RA disease activity, physician and patient global assessments, pain (VAS) and HAQ. DAS-28 was calculated. Vitamin D deficiency was defined as 25(OH)D levels<30ng/ml. RESULTS: Sixty-one percent of RA patients were classified as vitamin D deficient. In patients with active RA (DAS 28 score≥2.6), 25(OH)D was moderately and inversely associated with DAS 28 (-0.38), pain (-0.49) and HAQ (-0.54) (p<0.01). However, no significant associations were found between 25(OH)D and these variables in patients in remission (DAS 28<2.6). Vitamin D deficient patients with active RA had six times the odds (OR=6.0, 95% CI 1.2-31.2) of being moderately or severely disabled (HAQ≥1.25). CONCLUSIONS: Vitamin D deficiency was common in this RA group. In patients with moderate to high disease activity, vitamin D deficiency was associated with higher DAS scores, pain and disability. Clinicians in northern climates may wish to monitor vitamin D status in their RA patients.

A catalyst for transforming health systems and person-centred care: Canadian national position statement on patient-reported outcomes.

Background: Patient-reported outcomes (pros) are essential to capture the patient's perspective and to influence care. Although pros and pro measures are known to have many important benefits, they are not consistently being used and there is there no Canadian pros oversight. The Position Statement presented here is the first step toward supporting the implementation of pros in the Canadian health care setting. Methods: The Canadian pros National Steering Committee drafted position statements, which were submitted for stakeholder feedback before, during, and after the first National Canadian Patient Reported Outcomes (canpros) scientific conference, 14-15 November 2019 in Calgary, Alberta. In addition to the stakeholder feedback cycle, a patient advocate group submitted a section to capture the patient voice. Results: The canpros Position Statement is an outcome of the 2019 canpros scientific conference, with an oncology focus. The Position Statement is categorized into 6 sections covering 4 theme areas: Patient and Families, Health Policy, Clinical Implementation, and Research. The patient voice perfectly mirrors the recommendations that the experts reached by consensus and provides an overriding impetus for the use of pros in health care. Conclusions: Although our vision of pros transforming the health care system to be more patient-centred is still aspirational, the Position Statement presented here takes a first step toward providing recommendations in key areas to align Canadian efforts. The Position Statement is directed toward a health policy audience; future iterations will target other audiences, including researchers, clinicians, and patients. Our intent is that future versions will broaden the focus to include chronic diseases beyond cancer.

Convective flow in the presence of a small obstacle: Symmetry breaking, attractors, hysteresis, and information.

This work explores the stability and hysteresis effects that occur when a small sink of momentum is introduced into a heat-driven, two-dimensional convective flow. As per standard fluid mechanical intuition, the system minimizes work generation and dissipation when one component of momentum is extracted. However, when the sink absorbs all incoming momentum, the system configures itself such that one of the convection plumes aligns directly with the sink. This state is the most hydrodynamically stable, but it maximizes, rather than minimizes extracted mechanical work. Furthermore, in the case of only vertical momentum extraction, there are two attractors, with different stabilities. Numerical experiments involving slow variations of the horizontal momentum extraction show a clear history dependence. This hysteresis preserves information about the system's past states, and hence represents a primitive memory. The momentum sink can also be used to manipulate the horizontal position of the flow field, with potential applications in microfluidics and laminar convection systems. This simple system exhibits the phenomena of autocatalysis (during the initial growth of the convection plumes), negative feedback (the attractors are either fully or quasistable), memory, and elementary computation.

Boolean logic by convective obstacle flows.

We present a potential new mode of natural computing in which simple, heat-driven fluid flows perform Boolean logic operations. The system comprises a two-dimensional single-phase fluid that is heated from below and cooled from above, with two obstacles placed on the horizontal mid-plane. The obstacles remove all vertical momentum that flows into them. The horizontal momentum extraction of the obstacles is controlled in a binary fashion, and constitutes the 2-bit input. The output of the system is a thresholded measure of the energy extracted by the obstacles. Due to the existence of multiple attractors in the phase space of this system, the input-output relationships are equivalent to those of the OR, XOR or NAND gates, depending on the threshold and obstacle separation. The ability to reproduce these logical operations suggests that convective flows might have the potential to perform more general computations, despite the fact that they do not involve electronics, chemistry or multiple fluid phases.

Palindromic Rheumatism Frequently Precedes Early Rheumatoid Arthritis: Results From an Incident Cohort.

BACKGROUND: This multicenter incident cohort aimed to characterize how often early rheumatoid arthritis (ERA) patients self-report episodic joint inflammation (palindromic rheumatism) preceding ERA diagnosis and which characteristics differentiate these patients from those without prior episodic symptoms. METHODS: Data were from patients with early confirmed or suspected RA (more than 6 weeks and less than 12 months) enrolled in the Canadian Early ArThritis CoHort (CATCH) between April 2017 to March 2018 who completed study case report forms assessing joint pain and swelling prior to ERA diagnosis. Chi-square and t tests were used to compare characteristics of patients with and without self-reported episodic joint inflammation prior to ERA diagnosis. Multivariable logistic regression was used to identify sociodemographic and clinical measures associated with past episodic joint inflammation around the time of ERA diagnosis. RESULTS: A total of 154 ERA patients were included; 66% were female, and mean (SD) age and RA symptom duration were 54 (15) years and 141 (118) days. Sixty-five (42%) ERA patients reported a history of episodic joint pain and swelling, half of whom reported that these symptoms preceded ERA diagnosis by over 6 months. ERA patients with past episodic joint inflammation were more often female, had higher income, were seropositive, had more comorbidities, fewer swollen joints, and lower Clinical Disease Activity Index (CDAI) around the time of ERA diagnosis (P < 0.05). These associations remained significant in multivariable regression adjusting for other sociodemographic and RA clinical measures. CONCLUSION: Almost half of ERA patients experienced episodic joint inflammation prior to ERA diagnosis. These patients were more often female, had higher income, and presented with milder disease activity at ERA diagnosis.

Prevalence and Characteristics of Metabolic Syndrome Differ in Men and Women with Early Rheumatoid Arthritis.

Objective: Metabolic syndrome (MetS) prevalence in early rheumatoid arthritis (ERA) is conflicting. The impact of sex, including menopause, has not been described. We estimated the prevalence and factors associated with MetS in men and women with ERA. Methods: A cross-sectional study of the Canadian Early Arthritis Cohort (CATCH) was performed. Participants with baseline data to estimate key MetS components were included. Sex-stratified logistic regression identified baseline variables associated with MetS. Results: The sample included 1543 participants; 71% were female and the mean age was 54 (SD 15) years. MetS prevalence was higher in men 188 (42%) than women 288 (26%, P < 0.0001) and increased with age. Frequent MetS components in men were hypertension (62%), impaired glucose tolerance (IGT, 40%), obesity (36%), and low high-density lipoprotein cholesterol (36%). Postmenopausal women had greater frequency of hypertension (65%), IGT (32%), and high triglycerides (21%) compared with premenopausal women (P < 0.001). In multivariate analysis, MetS was negatively associated with seropositivity and pulmonary disease in men. Increasing age was associated with MetS in women. In postmenopausal women, corticosteroid use was associated with MetS. Psychiatric comorbidity was associated with MetS in premenopausal women. MetS status was not explained by disease activity or core RA measures. Conclusion: The characteristics and associations of MetS differed in men and women with ERA. Sex differences, including postmenopausal status, should be considered in comorbidity screening. With this knowledge, the interplay of MetS, sex, and RA therapeutic response on cardiovascular outcomes should be investigated.

Patient adherence in COPD.

Patient adherence to treatment in chronic obstructive pulmonary disease (COPD) is essential to optimise disease management. As with other chronic diseases, poor adherence is common and results in increased rates of morbidity, healthcare expenditures, hospitalisations and possibly mortality, as well as unnecessary escalation of therapy and reduced quality of life. Examples include overuse, underuse, and alteration of schedule and doses of medication, continued smoking and lack of exercise. Adherence is affected by patients' perception of their disease, type of treatment or medication, the quality of patient provider communication and the social environment. Patients are more likely to adhere to treatment when they believe it will improve disease management or control, or anticipate serious consequences related to non-adherence. Providers play a critical role in helping patients understand the nature of the disease, potential benefits of treatment, addressing concerns regarding potential adverse effects and events, and encouraging patients to develop self-management skills. For clinicians, it is important to explore patients' beliefs and concerns about the safety and benefits of the treatment, as many patients harbour unspoken fears. Complex regimens and polytherapy also contribute to suboptimal adherence. This review addresses adherence related issues in COPD, assesses current efforts to improve adherence and highlights opportunities to improve adherence for both providers and patients.

Exploring Perceptions of Barriers, Facilitators, and Motivators to Physical Activity Among Female Bariatric Patients: Implications for Physical Activity Programming.

PURPOSE: To explore barriers, facilitators, and motivators to adopting and maintaining regular physical activity among women with obesity who have undergone bariatric surgery. APPROACH: Individual interviews with women 3 to 24 months post-bariatric surgery. SETTING: Participants were recruited from a bariatric clinic in Montreal, Canada. PARTICIPANTS: Twelve women were recruited (mean age = 47 ± 9 years) using poster advertisements and word of mouth. Participants were on average 15 months postsurgery. METHOD: Each woman was interviewed once using a semistructured interview protocol. Recruitment was conducted until data saturation (i.e., no new information emerged). The interviews were transcribed, coded, and analyzed using inductive thematic analysis. RESULTS: Three interrelated themes emerged: the physical body, appraisal of the physical and social self, and the exercise environment. Barriers included weight-restricted mobility, side effects of surgery, body dissatisfaction, compromised psychological health, competing responsibilities, a lack of exercise self-efficacy and social support, reduced access to accommodating facilities, lack of exercise knowledge, and northern climate. Participants reported postsurgical weight loss, weight and health maintenance, enjoyment, body image, and supportive active relationships, as well as access to accommodating facilities and exercise knowledge, as facilitators and motivators. CONCLUSION: Suggested physical activity programming strategies for health care professionals working with this unique population are discussed. Physical activity and health promotion initiatives can also benefit from a cultural paradigm shift away from weight-based representations of health.

Relation of weight loss to changes in serum lipids and lipoproteins in obese women.

Several reports have suggested that modest weight losses, as little as 10% of initial weight, are sufficient to control many of the health complications of obesity. This study examined the relation between changes in weight and those in serum lipids and lipoproteins in obese women who participated in a 48-wk weight-reduction study. Subjects were 66 obese women who were prescribed a 3870-kJ (925-kcal)/d diet for the first 16 wk and a balanced-deficit diet of 5029-6279 kJ (1200-1500 kcal)/d thereafter. Anthropometric measures were assessed at baseline and weeks 8, 24, and 48, as were serum triacylglycerols (triglycerides), total cholesterol, and low-density-lipoprotein- and high-density-lipoprotein-cholesterol concentrations. Weight decreased 11.1% during the first 8 wk, during which time triacylglycerols and total cholesterol fell 22.7% and 15.7%, respectively. Subjects lost an additional 4.7 kg (equal to a total reduction of 16.4%) between weeks 8 and 24 but triacylglycerols and total and low-density-lipoprotein cholesterol increased by 5.2%, 4.2%, and 4.5%, respectively during this time. Multiple-regression analyses showed that at no time did weight loss account for > 6% of the variance in the reductions in triacylglycerol and cholesterol concentrations. These findings indicate that modest weight losses are associated with significant improvements in serum lipids, but that factors including the energy and macronutrient content of the diet prescribed contribute significantly to the improvements observed.

A controlled comparison of three very-low-calorie diets: effects on weight, body composition, and symptoms.

To determine the optimal energy intake of very-low-calorie diets (VLCDs), 76 obese women were randomly assigned, in a double-blind fashion, to one of three liquid-formula diets: 1758 kJ/d (420 kcal/d), 2763 kJ/d (660 kcal/d), or 3349 kJ/d (800 kcal/d). Weight, body composition, symptoms, mood, and acceptability of the diet were assessed throughout the 6-mo study. There were no significant differences in weight losses or changes in body composition among the three dietary conditions at the end of treatment, nor were there significant differences among conditions in acceptability of the diet, symptoms, or mood. These results suggest that there is no clinical advantage to using VLCDs that provide less than 3349 kJ/d (800 kcal/d).

Prevalence of significant knee pain among older Americans: results from the Third National Health and Nutrition Examination Survey.

OBJECTIVE: To assess the prevalence of persistent knee pain among older adults in the US. DESIGN: A nationally representative cross-sectional survey with an in-person interview and medical examination SETTING AND PARTICIPANTS: Between 1988 and 1994, 6596 adults aged 60 to 90+ years were examined as part of the National Health and Nutrition Examination Survey III. Mexican Americans and non-Hispanic blacks were over-sampled to produce reliable estimates for these groups. MAIN OUTCOME MEASUREMENTS: Participants were asked to report whether they had experienced knee pain on most days for the 6 weeks preceding their medical exam. RESULTS: Overall, 18.1% of US men and 23.5% of US women aged 60 years and older reported knee pain. Sixty- to ninety-year-old men reported knee pain less frequently than their age-matched female counterparts. There was a trend for reports of knee pain to increase steadily as these adults aged from 60 to 85 years. The highest prevalence of knee pain was reported among 85- to 90-year-old men (23.7%) and women (30.0%). Among non-Hispanic white adults older than age 60, 18.4% of men and 22.0% of women reported knee pain. Reports of knee pain among non-Hispanic black men and Mexican American men were similar to those of their non-Hispanic white counterparts. In contrast, 26.4% of Mexican American women and 32.8% of non-Hispanic black women reported knee pain. We also found that difficulty in performing physical functioning activities was associated with a higher prevalence of knee pain. CONCLUSIONS: Many US adults older than age 60 years report knee pain, and the prevalence is higher in older adults. Reports of knee pain are highest among non-Hispanic black women and the oldest Americans. Intervention strategies are needed to prevent and better manage knee pain among older US adults to stem the adverse health consequences and diminished quality of life associated with this common problem.

Maternal depressive symptoms and emergency department use among inner-city children with asthma.

CONTEXT: Inner-city minority children with asthma use emergency departments (ED) frequently. OBJECTIVE: To examine whether maternal depressive symptoms are associated with ED use. DESIGN, SETTING, AND PATIENTS: Baseline and 6-month surveys were administered to mothers of children with asthma in inner-city Baltimore, Md, and Washington, DC. MAIN OUTCOME MEASURES: Use of the ED at 6-month follow-up was examined. Independent variables included asthma morbidity, age, depressive symptoms, and other psychosocial data. RESULTS: Among mothers, nearly half reported significant levels of depressive symptoms. There were no demographic or asthma-related differences between the children of mothers with high and low depressive symptoms. However, in bivariate analyses, mothers with high depressive symptoms were 40% (prevalence ratio [PR], 1.4; 95% confidence interval [CI], 1.0-3.6; P =.04) more likely to report taking their child to the ED. Mothers aged 30 to 35 years were more than twice as likely (PR, 2.2; 95% CI, 1.9-9.3; P =.001) to report ED use, as were children with high morbidity (PR, 1.9; 95% CI, 1.4-7.1; P =.006). Child age and family income were not predictive of ED use. After controlling for asthma symptoms and mother's age, mothers with depressive symptoms were still 30% more likely to report ED use. CONCLUSIONS: Depression is common among inner-city mothers of children with asthma. Beyond asthma morbidity, maternal age and depressive symptoms are strong predictors of reports of ED visits. Identifying and addressing poor psychological adjustment in mothers may reduce unnecessary ED visits and optimize asthma management among inner-city children.

Television watching, energy intake, and obesity in US children: results from the third National Health and Nutrition Examination Survey, 1988-1994.

OBJECTIVES: To examine the relationship between television watching, energy intake, physical activity, and obesity status in US boys and girls, aged 8 to 16 years. METHODS: We used a nationally representative cross-sectional survey with an in-person interview and a medical examination, which included measurements of height and weight, daily hours of television watching, weekly participation in physical activity, and a dietary interview. Between 1988 and 1994, the Third National Health and Nutrition Examination Survey collected data on 4069 children. Mexican Americans and non-Hispanic blacks were oversampled to produce reliable estimates for these groups. RESULTS: The prevalence of obesity is lowest among children watching 1 or fewer hours of television a day, and highest among those watching 4 or more hours of television a day. Girls engaged in less physical activity and consumed fewer joules per day than boys. A higher percentage of non-Hispanic white boys reported participating in physical activity 5 or more times per week than any other race/ethnic and sex group. Television watching was positively associated with obesity among girls, even after controlling for age, race/ethnicity, family income, weekly physical activity, and energy intake. CONCLUSIONS: As the prevalence of overweight increases, the need to reduce sedentary behaviors and to promote a more active lifestyle becomes essential. Clinicians and public health interventionists should encourage active lifestyles to balance the energy intake of children.

Psychosocial consequences of weight cycling.

Participants were 130 obese women with a mean age of 41.1 +/- 8.4 years and a mean weight of 97.9 +/- 13.5 kg, who reported having undertaken a mean lifetime total of 4.7 +/- 1.2 major diets on which they had lost a mean total of 45.9 +/- 21.4 kg. Participants with a severe history of weight cycling had a significantly younger age of onset of their obesity than did mild cyclers and reported initiating dieting at a significantly younger age and lower weight. No evidence, however, was found that weight cycling was associated with greater reports of depression or other psychopathology; nor was it associated with a significantly greater frequency of binge eating disorder. The results are discussed in terms of the need to use additional measures of psychological functioning.

Exercise in the treatment of obesity: effects of four interventions on body composition, resting energy expenditure, appetite, and mood.

This study investigated changes in body composition, resting energy expenditure (REE), appetite, and mood in 128 obese women who were randomly assigned to 1 of 4 treatment conditions: diet alone, diet plus aerobic training, diet plus strength training, or diet combined with aerobic and strength training (i.e., combined training). All women received the same 48-week group behavioral program and were prescribed the same diet. Exercising participants were provided 3 supervised exercise sessions per week for the first 28 weeks and 2 sessions weekly thereafter. Participants across the 4 conditions achieved a mean weight loss of 16.5 +/- 6.8 kg at Week 24, which decreased to 15.1 +/- 8.4 kg at Week 48. There were no significant differences among conditions at any time in changes in weight or body composition. Women who received aerobic training displayed significantly smaller reductions in REE at Week 24 than did those who received strength training. There were no other significant differences among conditions at any time on this variable or in changes in appetite and mood.

Behavioral treatment of obese binge eaters: do they need different care?

This study investigated the relationship between binge eating and the outcome of weight loss treatment. Participants in a 48-week trial of a structured diet combined with exercise and behavior therapy were classified into one of four groups: no overeating; episodic overeating; subthreshold binge-eating disorder(BED); and BED. Binge eating status was not associated with either dropout or adherence to the diet, but did affect weight loss and mood. The BED group lost significantly more weight at the end of treatment than all other groups, even when adjusting for initial weight. At 1-year follow-up, there were no differences among groups in weight loss or weight regain. The BED group began treatment with significantly higher BDI scores, but improvement in mood occurred by week 5. On the basis of these findings, and a review of the recent literature, we conclude that obese binge eaters respond as favorably to standard dietary and behavioral treatments as do obese nonbingers.