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Summary Background No trials have tested multifaceted mental health interventions recommended by public health organisations during COVID-19. The objective of this trial was to evaluate the effect of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Program on anxiety symptoms and other mental health outcomes among people vulnerable during COVID-19 owing to a pre-existing medical condition. Methods The SPIN-CHAT Trial was a pragmatic, two-arm, parallel, partially nested, randomised, controlled trial (1:1 allocation to intervention or waitlist). Eligible participants with systemic sclerosis were recruited from the international SPIN COVID-19 Cohort. SPIN COVID-19 Cohort participants were eligible for the trial if they completed baseline measures and had at least mild anxiety symptoms, had not tested positive for COVID-19, and were not currently receiving mental health counselling. SPIN-CHAT is a 4-week (3 sessions per week) videoconference-based group intervention that provided education and practice with mental health coping strategies, and provided social support to reduce isolation. Groups included 6–10 participants. The primary outcome analysed in the intention-to-treat population was anxiety symptoms (PROMIS Anxiety 4a version 1.0) immediately post-intervention. This trial is registered with ClinicalTrials.gov, NCT04335279 and is complete. Findings Of participants who completed baseline measures between April 9, 2020, and April 27, 2020, 560 participants were eligible and 172 participants were randomly assigned to intervention (n=86) or waitlist (n=86). Mean age was 55·0 years (SD 11·4 years), 162 (94%) were women, and 136 (79%) identified as White. In intention-to-treat analyses, the intervention did not significantly reduce anxiety symptoms post-intervention (−1·57 points, 95% CI −3·59 to 0·45; standardised mean difference [SMD] −0·22 points) but reduced symptoms 6 weeks later (−2·36 points, 95% CI −4·56 to −0·16; SMD −0·31). Depression symptoms were significantly lower 6 weeks post-intervention (−1·64 points, 95% CI −2·91 to −0·37; SMD −0·31); no other secondary outcomes were significant. No adverse events were reported. Interpretation The intervention did not significantly improve anxiety symptoms or other mental health outcomes post-intervention. However, anxiety and depression symptoms were significantly lower 6 weeks later, potentially capturing the time it took for new skills and social support between intervention participants to affect mental health. Multi-faceted interventions such as SPIN-CHAT have potential to address mental health needs in vulnerable groups during COVID-19, yet uncertainty remains about effectiveness. Funding Canadian Institutes of Health Research (CIHR; VR4-172745, MS1-173066); McGill Interdisciplinary Initiative in Infection and Immunity Emergency COVID-19 Research Fund; Scleroderma Canada, made possible by an educational grant for patient support programming from Boehringer Ingelheim; the Scleroderma Society of Ontario; Scleroderma Manitoba; Scleroderma Atlantic; Scleroderma Australia; Scleroderma New South Wales; Scleroderma Victoria; Scleroderma Queensland; Scleroderma SASK; the Scleroderma Association of BC; and Sclerodermie Quebec.

Background Obtaining the patient's view about the outcome of care is an essential component of patient-centered care. Many patient-reported outcome (PRO) instruments for different purposes have been developed since the 1960s. Measurement validation is fundamental in the development, evaluation, and use of PRO instruments. Objectives This paper provides a review of modern perspectives of measurement validation in relation to the followings three questions as applied to PROs: (1) What evidence is needed to warrant comparisons between groups and individuals? (2) What evidence is needed to warrant comparisons over time? and (3) What are the value implications, including personal and societal consequences, of using PRO scores? Discussion Measurement validation is an ongoing process that involves the accumulation of evidence regarding the justification of inferences, actions, and decisions based on measurement scores. These include inferences pertaining to comparisons between groups and comparisons over time as well as consideration of value implications of using PRO scores. Personal and societal consequences must be examined as part of a comprehensive approach to measurement validation. The answers to these three questions are fundamental to the the validity of different types of inferences, actions, and decisions made on PRO scores in health research, health care administration, and clinical practice.

Background Patient-centered health care, where we design and deliver care to address the needs and preferences of patients, represents an important paradigm shift. Patient-reported outcomes (PROs) are critical to capture the patient voice, understand how illness and treatments affect people, and establish how well services and treatments address what matters most to patients. Objective Originally developed for use in research, PROs are now used to monitor individuals and populations, manage care, evaluate services and providers, and inform policy. However, moving PROs beyond research settings incurs considerable methodological, organizational, technological, and ethical considerations. National collaborative networks of researchers, clinicians, patients, and other stakeholders can address these challenges by coordinating development, creating standards for use, sharing costs and delivery platforms, and improving widespread uptake of core sets of measures to better inform health care decisions and improve outcomes. Discussion We introduce eight papers from researchers, clinicians, patients, and decision makers who participated in deliberations around creating a national network to accelerate the application and harmonized use of PROs in Canada. They offer a snap shot of the strategies that pioneers and innovative thinkers are using to integrate the patient voice into comprehensive care, research, and health policy planning of chronic diseases.

Background Given that the goal of health care systems is to improve and maintain the health of the populations they serve, the indicators of performance must include outcomes that are meaningful to patients. The growth of health technologies provides an unprecedented opportunity to integrate the patient voice into clinical care by linking electronic health records (EHRs) to patient-reported outcome (PRO) data collection. However, PRO data must be relevant, meaningful, and actionable for those who will have to invest the time and effort to collect it. Objective In this study, we highlight opportunities to integrate PRO data collection into EHRs. We consider how stakeholder perspectives should influence the selection of PROs and ways to enhance engagement in and commitment to PRO implementation. We propose a research and policy agenda to address unanswered questions and facilitate the widespread adoption of PRO data collection into EHRs. Discussion Building a learning health care system that gathers PRO data in ways that can inform individual patient care, quality improvement, and comparative effectiveness research has the potential to accelerate the application of new evidence and knowledge to patient care.

Background US fruit and vegetable (FV) intake remains below recommendations, particularly for low-income populations. Evidence on effectiveness of rebates in addressing this shortfall is limited. Objective This study evaluated the USDA Healthy Incentives Pilot (HIP), which offered rebates to Supplemental Nutrition Assistance Program (SNAP) participants for purchasing targeted FVs (TFVs). Design As part of a randomized controlled trial in Hampden County, Massachusetts, 7500 randomly selected SNAP households received a 30% rebate on TFVs purchased with SNAP benefits. The remaining 47,595 SNAP households in the county received usual benefits. Adults in 5076 HIP and non-HIP households were randomly sampled for telephone surveys, including 24-h dietary recall interviews. Surveys were conducted at baseline (1-3 mo before implementation) and in 2 follow-up rounds (4-6 mo and 9-11 mo after implementation). 2784 adults (1388 HIP, 1396 non-HIP) completed baseline interviews; data were analyzed for 2009 adults (72%) who also completed ≥1 follow-up interview. Results Regression-adjusted mean TFV intake at follow-up was 0.24 cup-equivalents/d (95% CI: 0.13, 0.34 cup-equivalents/d) higher among HIP participants. Across all fruit and vegetables (AFVs), regression-adjusted mean intake was 0.32 cup-equivalents/d (95% CI: 0.17, 0.48 cup-equivalents/d) higher among HIP participants. The AFV-TFV difference was explained by greater intake of 100% fruit juice (0.10 cup-equivalents/d; 95% CI: 0.02, 0.17 cup-equivalents/d); juice purchases did not earn the HIP rebate. Refined grain intake was 0.43 ounce-equivalents/d lower (95% CI: -0.69, -0.16 ounce-equivalents/d) among HIP participants, possibly indicating substitution effects. Increased AFV intake and decreased refined grain intake contributed to higher Healthy Eating Index-2010 scores among HIP participants (4.7 points; 95% CI: 2.4, 7.1 points). Conclusions The HIP significantly increased FV intake among SNAP participants, closing ∼20% of the gap relative to recommendations and increasing dietary quality. More research on mechanisms of action is warranted. The HIP trial was registered at clinicaltrials.gov as NCT02651064.

Objective The acute cardiorespiratory effects of air quality among children living in areas with considerable heavy industry have not been well investigated. We conducted a panel study of children with asthma living in proximity to an industrial complex housing two refineries in Montreal, Quebec, in order to assess associations between their personal daily exposure to air pollutants and changes in pulmonary function and selected indicators of cardiovascular health. Methods Seventy-two children with asthma age 7–12 years in 2009–2010 participated in this panel study for a period of 10 consecutive days. They carried a small backpack for personal monitoring of sulphur dioxide (SO 2 ), benzene, fine particles (PM 2.5 ), nitrogen dioxide (NO 2 ) and polycyclic aromatic hydrocarbons (PAHs) and underwent daily spirometry and cardiovascular testing (blood pressure, pulse rate and oxygen saturation). To estimate these associations, we used mixed regression models, adjusting for within-subject serial correlation, and for the effects of a number of personal and environmental variables (e.g., medication use, ethnicity, temperature). Results Children with asthma involved in the study had relatively good pulmonary function test results (mean FEV 1 compared to standard values: 89.8%, mean FVC: 97.6%, mean FEF 25–75 : 76.3%). Median diastolic, systolic blood pressures and oxygen saturation were 60/94 mm Hg and 99%, respectively. Median personal concentrations of pollutants were NO 2 , 5.5 ppb; benzene, 2.1 µg/m 3 ; PM 2.5 , 5.7 µg/m 3 ; and total PAH, 130 µg/m 3 . Most personal concentrations of SO 2 were below the level of detection. No consistent associations were observed between cardio-pulmonary indices and personal exposure to PM 2.5 , NO 2 and benzene, although there was a suggestion for a small decrease in respiratory function with total concentrations of PAHs (e.g., adjusted association with FVC: −9.9 ml per interquartile range 95%CI: −23.4, 3.7). Conclusions This study suggests that at low daily average levels of exposure to industrial emissions, effects on pulmonary and cardiovascular functions in children with asthma may be difficult to detect over 10 consecutive days.

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.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.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.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.

Study objectives To evaluate the effect of depressive symptoms on adherence to therapy after discharge in patients hospitalized for asthma exacerbations. Design Prospective cohort study in which depressive symptoms were assessed during hospitalization and use of asthma medications was electronically monitored for 2 weeks after discharge. Setting Inner-city academic hospital in Baltimore, MD. Patients Patients were 59 adults with a mean age of 43.2 ± 10.9 years (± SD), who were mostly female (64%), African American (80%), and were hospitalized for an asthma exacerbation. Measurement and results Depressive symptoms were assessed with the Center for Epidemiological Studies-Depression scale. Electronic monitors were used to evaluate inhaled corticosteroid and oral corticosteroid use for up to 2 weeks after discharge. Forty-one percent of patients had high levels of depressive symptoms. Mean adherence to therapy was significantly lower in patients with (vs without) high levels of depressive symptoms (60 ± 26% vs 74 ± 21%, p + 0.02). Even after controlling for age, gender, and education, depressive symptoms were a significant and independent predictor of poorer adherence. High levels of depressive symptoms were associated with a 11.4-fold increase (95% confidence interval, 2.2 to 58.2) in the odds of poor adherence to therapy after adjustment for potential confounders. Conclusions Depressive symptoms are common in inner-city adults hospitalized for asthma exacerbations and identify a subset of patients at high risk for poor adherence to asthma therapy after discharge. Further research is needed to determine if screening for and treating depression improves adherence and asthma outcomes in this population.

A recent genomewide scan in psoriatic arthritis (PsA) revealed a susceptibility locus at 16q. This region overlaps CARD15, a susceptibility gene in Crohn disease. The possibility of a common susceptibility gene between PsA and Crohn disease is further supported by epidemiological studies that note an increased incidence of psoriasis in subjects with Crohn. We screened 187 patients with PsA and 136 healthy controls, all from Newfoundland, for the three common, independent sequence variants of CARD15 (R702W, leu1007fsinsC, and G908R), which were detected by polymerase chain reaction by use of allele-specific primers and visualized through gel electrophoresis. In total, 53/187 (28.3%) probands with PsA had at least one variant of the CARD15 gene, compared with 16/136 (11.8%) controls (odds ratio 2.97; 95% confidence interval 1.61-5.47; P=.0005). Allele frequencies of R702W, leu1007fsinsC, and G908R were 10.43%, 3.21%, and 1.61%, respectively, in patients with PsA, compared with 3.31%, 2.57%, and 0.37%, respectively, in the control patients. CARD15 conferred susceptibility to PsA independent of HLA-Cw*0602. Thus, CARD15 represents a pleiotropic autoimmune gene and is the first non-MHC gene to be associated with PsA.

Moderate intensity physical activity achieved through changes in lifestyle may promote weight management. However, little is known about changes in physiologic and metabolic variables when patients lose weight using moderate intensity lifestyle activity instead of traditional structured vigorous aerobic exercise. To compare changes in resting metabolic energy expenditure (REE), fat mass (FM), and fat-free mass (FFM) associated with a 12-week weight loss program combined with either: (1) aerobic exercise (AER); or (2) lifestyle activity (LIFE), we randomized 39 overweight adults (mean body mass index [BMI] = 30.9 +/- 2.8 kg/m(2)) to either diet plus AER (N = 18) or diet plus LIFE (N = 21). Both groups consumed a self-selected diet of 1,200 to 1,800 kcal/d (5,021 to 7,531 kJ/d). The AER group performed vigorous aerobic exercise for up to 45 minutes 3 to 4 d/wk. The LIFE group accumulated 30 minutes of moderate intensity physical activity on most days of the week. Compliance with the respective protocols was monitored on a weekly basis. REE was measured before and after treatment via open-circuit spirometry. The AER group decreased body weight by 8.4% (P

Background: Environmental tobacco smoke (ETS) is a frequent exposure and is linked to asthma among inner-city children. Objective: We sought to examine the relationship among ETS exposure, select asthma symptoms, and consequences among inner-city children with asthma. Methods: Data from interviews with primary caregivers of inner-city elementary school children with asthma were evaluated (n = 590). Caregiver reports of child asthma symptoms, exercise limitations, asthma management, health care use, and ETS exposure were examined. Results: Smoking in the home was reported by 29.4% of primary caregivers. ETS exposure (yes/no) was not related to frequency of child nocturnal symptoms or other select asthma morbidity markers. However, among children exposed to ETS, the frequency and severity of child nocturnal symptoms were highest among children exposed to moderate-to-heavy levels of ETS. After controlling for child age, anti-inflammatory medication use, asthma primary care, and caregiver's education, exposure to higher levels of ETS was associated with nearly a 3-fold increase in nocturnal symptoms in children (odds ratio, 2.83; 95% CI, 1.22-6.55). Conclusion: Among elementary school inner-city children with asthma, exposure to higher levels of ETS was associated with increased frequency of nocturnal symptoms. Reducing the exposure of children with asthma to ETS should be a clear priority in developing effective asthma management plans for inner-city families. (J Allergy Clin Immunol 2002;110:147-53.)

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.

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).

Background Information that enhances expectations about drug effectiveness improves the response to placebos for pain. Although asthma symptoms often improve with placebo, it is not known whether the response to placebo or active treatment can be augmented by increasing expectation of benefit. Objective The study objective was to determine whether response to placebo or a leukotriene antagonist (montelukast) can be augmented by messages that increase expectation of benefit. Methods A randomized 20-center controlled trial enrolled 601 asthmatic patients with poor symptom control who were assigned to one of 5 study groups. Participants were randomly assigned to one of 4 treatment groups in a factorial design (ie, placebo with enhanced messages, placebo with neutral messages, montelukast with enhanced messages, or montelukast with neutral messages) or to usual care. Assignment to study drug was double masked, assignment to message content was single masked, and usual care was not masked. The enhanced message aimed to increase expectation of benefit from the drug. The primary outcome was mean change in daily peak flow over 4 weeks. Secondary outcomes included lung function and asthma symptom control. Results Peak flow and other lung function measures were not improved in participants assigned to the enhanced message groups versus the neutral messages groups for either montelukast or placebo; no differences were noted between the neutral placebo and usual care groups. Placebo-treated participants had improved asthma control with the enhanced message but not montelukast-treated participants; the neutral placebo group did have improved asthma control compared with the usual care group after adjusting for baseline difference. Headaches were more common in participants provided messages that mentioned headache as a montelukast side effect. Conclusions Optimistic drug presentation augments the placebo effect for patient-reported outcomes (asthma control) but not lung function. However, the effect of montelukast was not enhanced by optimistic messages regarding treatment effectiveness.