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Purpose: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core Questionnaire (QLQ-C30) is a widely used generic self-report measure of health-related quality of life (HRQOL) for cancer patients. However, no validated voice script for interviewer-led telephone administration was previously available. The aim of this study was to develop a voice script for interviewer administration via telephone. Methods: Following guidelines from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) PRO Mixed Modes Good Research Practices Task Force, a randomised cross-over equivalence study, including cognitive debriefing, was conducted to assess equivalence between paper and telephone administration modes. Assuming an expected intraclass correlation coefficient (ICC) of 0.70 and a minimally acceptable level of 0.50, a sample size of 63 was required. Results: Cognitive interviews with five cancer patients found the voice script to be clear and understandable. Due to a protocol deviation in the first wave of testing, only 26 patients were available for analyses. A second wave of recruitment was conducted, adding 37 patients (n = 63; mean age 55.48; 65.1% female). Total ICCs for mode comparison ranged from 0.72 (nausea and vomiting, 95% CI 0.48–0.86) to 0.90 (global health status/QoL, 95% CI 0.80–0.95; pain, 95% CI 0.79–0.95; constipation, 95% CI 0.80–0.95). For paper first administration, all ICCs were above 0.70, except nausea and vomiting (ICC 0.55; 95% CI 0.24–0.76) and financial difficulties (ICC 0.60; 95% CI 0.31–0.79). For phone first administration, all ICCs were above 0.70. Conclusions: The equivalence testing results support the voice script's validity for administration of the QLQ-C30 via telephone. [ABSTRACT FROM AUTHOR]

Background: Palmitoylethanolamide (PEA) has analgesic/anti-inflammatory properties that may be a suitable alternative to over-the-counter (OTC) non-steroidal analgesics/anti-inflammatories. While OTC pain medications can impair strength training adaptations, the mechanism of action of PEA is distinct from these and it may not negatively affect skeletal muscle adaptations to strength training. Methods: The primary aim of this study was to investigate the effects of daily PEA supplementation (350 mg Levagen + equivalent to 300 mg PEA) combined with 8-weeks of resistance training on lean body mass with secondary aims addressing strength, power, sleep, and wellbeing compared to placebo (PLA) in young, healthy, active adults. In a randomized, controlled, double-blinded trial, 52 untrained, recreationally active participants aged 18–35 y were allocated to either the PEA or PLA groups. Participants consumed either 2 × 175 mg Levagen + PEA or identically matched maltodextrin capsules during an 8-week period of whole-body resistance training. This trial assessed the pre- to post- changes in total and regional lean body mass, muscular strength (1-RM bench, isometric mid-thigh pull), muscular power [countermovement jump (CMJ), bench throw], pain associated with exercise training, sleep, and wellbeing compared with the PEA or PLA condition. Results: 48 Participants were included in the final intention to treat (ITT) analysis and we also conducted per protocol (PP) analysis (n = 42). There were no significant between-group differences for total or regional lean muscle mass post-intervention. There was a significantly higher jump height (CMJ) at week 10 in the PEA group compared to the PLA (Adjusted mean difference [95% CI] p-value; ITT: − 2.94 cm [− 5.15, − 0.74] p = 0.010; PP: − 2.93 cm [− 5.31, − 0.55] p = 0.017). The PLA group had higher 1-RM bench press post-intervention compared with the PEA group (ITT: 2.24 kg [0.12, 4.37] p = 0.039; PP: 2.73 kg [0.40, 5.06] p = 0.023). No significant treatment effects were noted for any of the other outcomes. Conclusion: PEA supplementation, when combined with 8 weeks of strength training, did not impair lean mass gains and it resulted in significantly higher dynamic lower-body power when compared with the PLA condition. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR: ACTRN12621001726842p). Key Findings: Palmitoylethanolamide (PEA) is a compound that works as an anti-inflammatory and analgesic for the management of pain that works on different biochemical pathways compared to other over-the-counter analgesics and non-steroidal anti-inflammatories. Our findings indicate that a daily dose of 300 mg of PEA administered during 8-weeks of strength training did not interfere with skeletal muscle hypertrophy gains and may improve lower body power (e.g., jump height) compared to the placebo group. PEA may fill the gap for athletes and the active population as an alternative method of pain management. [ABSTRACT FROM AUTHOR]

Background: Psychological distress is highly noticeable among caregivers working in residential youth care (RYC). Maintaining and enhancing caregivers' professional mental health and quality of life is crucial to achieve effective outcomes in RYC. Nevertheless, trainings to protect caregivers' mental health are scarce. Considering the buffering effect over negative psychological outcomes, compassion training could be beneficial in RYC. Objective: This study is part of a Cluster Randomized Trial examining the effects of the Compassionate Mind Training for Caregivers (CMT-Care Homes), looking at professional quality of life and mental health of caregivers working in RYC. Method: The sample was composed of 127 professional caregivers from 12 Portuguese residential care homes (RCH). RCHs were randomly allocated at experimental (N = 6) and control group (N = 6). Participants were assessed at baseline, post-treatment, and 3 and 6-month follow-ups, answering to the Professional Quality of Life Scale and the Depression, Anxiety and Stress Scale. Program effects were tested using a two-factor mixed MANCOVA, with self-critical attitude and education degree as covariates. Results: MANCOVA showed a significant Time × Group interaction effects (F = 1.890, p =.014; η p 2 =.050), with CMT-Care Homes participants presenting lower scores on burnout, anxiety, and depression at 3 and 6-months follow-ups, when compared with controls. Participants that received CMT-Care Homes considered the program useful to deal with pandemic threats and with youth during lockdowns. Conclusion: This study shows the benefits of the CMT-Care Homes in helping professional caregivers reducing burnout, anxiety and depression, and dealing with pandemic challenges in RYC. Trial registration: This cluster randomized trial was registered at ClinicalTrials.gov (TRN: NCT04512092) on 6th August 2020. [ABSTRACT FROM AUTHOR]

This study examined the effectiveness of a theory-based mHealth intervention on the quality of life (QOL) of people living with HIV. A randomized controlled trial was performed at two outpatient clinics in Hanoi, Vietnam. There were 428 patients with HIV/AIDs in selected clinics and were divided into the intervention arm (receiving HIV-assisted smartphone application and usual care) and the control arm (receiving only usual care). The WHOQOLHIV-BREF instrument was utilized to measure QOL. An intention-to-treat approach using Generalized Linear Mixed Model analysis was performed. The trial showed significant improvements in Physical health, Psychological health, and Level of Dependence among patients in the intervention arm compared to the control arm. However, the Environment and Spirituality/Personal beliefs improvements would require additional interventions, both individual, organizational, or governmental. This study explored the utility of a smartphone mobile application for individuals with HIV, and how the resultant application could improve the overall QOL. [ABSTRACT FROM AUTHOR]

Backgrounds and Objectives: The use of anti-inflammatory supplements is important in improving the executive function of obese people. This research aims to investigate the effect of 6 weeks of aerobic exercise with moderate intensity as well as the consumption of nanocurcumin on IL1β, nitric oxide (NO), and depression in women aged 60–65 with metabolic syndrome. Materials and Methods: Fourty-four women with metabolic syndrome were randomly selected and divided into four groups of 10 based on their use of nanocurcumin supplement. The treatment included the training (T), nanocurcumin (N), training + nanocurcumin (TN), and the control groups. The groups exposed to training performed aerobic exercise for 6 weeks (three sessions per week). Blood samples were obtained before and after the training period for antioxidant indicators and lipid degradation measurement. Also, the Beck anxiety questionnaire was used for evaluating levels of anxiety. T-test and one-way analysis of variance (ANOVA) tests were used for the assessment of within-group and between-group differences, respectively. Results: There was a significant difference in IL1β, NO, and depression before and after exercise in all three experimental groups (p ≤ 0.05). Also, the results showed a significant difference in the level of NO and depression in the experimental groups. The highest decrease in these variables was observed in the T and TN groups (p ≤ 0.05). Conclusion: These findings indicated that 6-week nanocurcumin supplementation with aerobic training is a suitable method for reducing IL1β, NO, and depression, preventing metabolic, cardiovascular, and inflammatory diseases in women with metabolic syndrome. Name of the registry: IR.SEMUMS.REC.1396.107 Trial registration number: IRCT2017082335857N1 [ABSTRACT FROM AUTHOR]

Background: A common method of pain assessment is the numerical rating scale, where patients are asked to rate their pain on a scale from 0 to 10, where 0 is "no pain" and 10 is "pain as bad as you can imagine". We hypothesize such language is suboptimal as it involves a test of a cognitive skill, imagination, in the assessment of symptom severity. Methods: We used a large-scale online research registry, ResearchMatch, to conduct a randomized controlled trial to compare the distributions of pain scores of two different pain scale anchors. We recruited adults located in the United States who reported a chronic pain problem (> 3 months) and were currently in pain. Participants were randomized in a 1:1 ratio to receive pain assessment based on a modified Brief Pain Inventory (BPI), where the anchor for a score of 10 was either "extremely severe pain", or the original BPI, with the anchor "pain as bad as you can imagine". Participants in both groups also answered additional questions about pain, other symptomatology and creativity. Results: Data were obtained from 405 participants for the modified and 424 for the original BPI. Distribution of responses to pain questions were similar between groups (all p-values ≥ 0.12). We did not see evidence that the relationship between pain score and the anchor text differed based on self-perceived creativity (all interaction p-values ≥ 0.2). However, in the key analysis, correlations between current pain assessments and known correlates (fatigue, anxiety, depression, current pain compared to a typical day, pain compared to other people) were stronger for "extreme" vs. "imaginable" anchor text (p = 0.005). Conclusion: Pain rating scales should utilize the modified anchor text "extremely severe pain" instead of "pain as bad as you can imagine". Further research should explore the effects of anchors for other symptoms. [ABSTRACT FROM AUTHOR]

Introduction: Perinatal depression is common among women living with HIV, but depression care is limited in low-resource settings. We examined (1) characteristics of women receiving Problem Solving Therapy (PST) versus antidepressant therapy (ADT), (2) treatment response by modality, and (3) correlates of treatment response. Methods: This analysis used data from 191 Ugandan women in the intervention arm of a cluster randomized controlled trial of task-shifted, stepped-care depression treatment for pregnant women living with HIV (PWLWH). Treatment response was defined as scoring < 5 on the nine-item Patient Health Questionnaire (PHQ-9). Bivariate analysis and multivariable logistic regression were used to examine characteristics of women by treatment group and correlates of treatment response. Results: Of 134 participants with depression, 129 (96%) were treated: 84 (65%) received PST and 45 (35%) received ADT. Severe depression at treatment initiation was more common in those receiving ADT (28.9% versus 4.8%, Fischer's Exact Test < 0.001). Treatment response was higher for PST (70/84; 83.3%) than ADT (30/45; 66.7%; p =.03). ADT side effects were rare and minor; no infants had serious congenital defects. Of 22 participants (19%) who did not respond to treatment, only five received intensified management. Social support and interpersonal violence were associated with treatment response (adjusted odds ratio, [aOR] = 3.06, 95% CI = 1.08–8.66 and aOR = 0.64, 95% CI = 0.44–0.93). Discussion: Both depression treatment modalities yielded high response rates in Ugandan PWLWH; ADT was well-tolerated. Our results highlight a need to build capacity to implement the stepped-care protocol for non-responders and screen for social support and interpersonal violence. Significance: What is Already Known on this Subject?Prior research has demonstrated the feasibility and effectiveness of delivering collaborative care for depression in low-resource settings including Uganda. What this Study adds?Both Problem-Solving Therapy and antidepressant therapy yielded high treatment response rates among pregnant women living with HIV in Uganda who met criteria for depression, and antidepressant therapy was well tolerated. This study highlights a need to build capacity to implement the task-shifted stepped-care protocol for women whose depression does not respond to initial treatment, and to screen for social support and interpersonal violence. [ABSTRACT FROM AUTHOR]

To address the unmet need for scalable solutions for lifestyle treatment, we developed a new digital method to promote behavioral change. Here we report that patients with type-2 diabetes in Sweden (n = 331) exposed to the intervention have significantly improved HbA1c during a median follow-up of 1038 days (4 mmol/mol compared with matched controls; P = 0.009). This is paralleled by reduced body weight, ameliorated insulin secretion, increased physical activity, and cognitive eating restraints. Participants with high BMI and insulin resistance have an even larger response, as have non-risk allele carriers for the FTO gene. The findings open a new avenue for scalable lifestyle management with sustained efficacy and highlight a previously unrecognized opportunity for digital precision treatment based on genetics and individual pathophysiology. ClinicalTrials.gov NCT04624321. [ABSTRACT FROM AUTHOR]

Congenital malformations of the central nervous system are among the most common major congenital malformations. Deep learning systems have come to the fore in prenatal diagnosis of congenital malformation, but the impact of deep learning-assisted detection of congenital intracranial malformations from fetal neurosonographic images has not been evaluated. Here we report a three-way crossover, randomized control trial (Trial Registration: ChiCTR2100048233) that assesses the efficacy of a deep learning system, the Prenatal Ultrasound Diagnosis Artificial Intelligence Conduct System (PAICS), in assisting fetal intracranial malformation detection. A total of 709 fetal neurosonographic images/videos are read interactively by 36 sonologists of different expertise levels in three reading modes: unassisted mode (without PAICS assistance), concurrent mode (using PAICS at the beginning of the assessment) and second mode (using PAICS after a fully unaided interpretation). Aided by PAICS, the average accuracy of the unassisted mode (73%) is increased by the concurrent mode (80%; P < 0.001) and the second mode (82%; P < 0.001). Correspondingly, the AUC is increased from 0.85 to 0.89 and to 0.90, respectively (P < 0.001 for all). The median read time per data is slightly increased in concurrent mode but substantially prolonged in the second mode, from 6 s to 7 s and to 11 s (P < 0.001 for all). In conclusion, PAICS in both concurrent and second modes has the potential to improve sonologists' performance in detecting fetal intracranial malformations from neurosonographic data. PAICS is more efficient when used concurrently for all readers. [ABSTRACT FROM AUTHOR]

Background: The COMET-ICE trial demonstrated that sotrovimab clinically and statistically significantly reduces the risk of all-cause > 24-h hospitalization or death due to any cause among patients with COVID-19 at high risk of disease progression. Patient-reported outcomes are important to capture symptom burden of COVID-19 and assess treatment effectiveness. This study investigated symptoms and their impact over the acute phase of COVID-19 infection among patients on sotrovimab versus placebo. Methods: Randomized (1:1), double-blind, multicenter, placebo-controlled, phase 2/3 study in 57 centers across five countries. Participants were non-hospitalized patients with symptomatic, mild-to-moderate COVID-19 and ≥ 1 baseline risk factor for disease progression (aged ≥ 55 years or ≥ 1 of the following: diabetes requiring medication, obesity, chronic kidney disease, congestive heart failure, chronic obstructive pulmonary disease, or moderate-to-severe asthma). An intravenous infusion of sotrovimab 500 mg or placebo was administered on Day 1. The FLU-PRO Plus questionnaire was administered once-daily with 24-h recall from Day 1–21, and at Day 29. Intensity and duration of COVID-19 symptoms were determined from area under the curve (AUC) and mean change in total and individual domain scores through Days 7, 14, and 21. Time to symptom alleviation was assessed. Results: In total, 1057 patients were randomized to sotrovimab (n = 528) or placebo (n = 529). At Day 7, mean decrease in FLU-PRO Plus total score (measured by AUC) was statistically significantly greater for patients on sotrovimab (–3.05 [95% confidence interval (CI) –3.27 to –2.83]) than placebo (–1.98 [95% CI –2.20 to –1.76]; difference –1.07 [95% CI –1.38 to –0.76]; p < 0.001). Significant differences were also observed at Days 14 and 21. A more rapid decline in symptom severity was observed with sotrovimab versus placebo through Week 1 and the first 21 days post-treatment. By Day 21, 41% of patients on sotrovimab and 34% on placebo reported symptom resolution. In a post-hoc analysis, median time to symptom alleviation was 4 and 6 days, respectively. Conclusions: Sotrovimab provides significant and rapid improvements in patient-reported COVID-19 symptoms, as measured by the FLU-PRO Plus. These results further show the benefits of sotrovimab in alleviating symptoms among high-risk patients with COVID-19. Trial registration ClinicalTrials.Gov: NCT04545060 (https://clinicaltrials.gov/ct2/show/NCT04545060). Date of registration: September 10, 2020 (retrospectively registered). [ABSTRACT FROM AUTHOR]

Objectives: Technology-based outreach offers promise for providing support to a broad population of postpartum mothers while keeping costs low. However, research on the efficacy of this approach is scarce. We conducted a pre-registered randomized pilot trial of the effects of a novel technology-based approach for supporting postpartum mothers – via text-based mentoring – from infant's birth through 18 months. Methods: Mothers (n = 201) were recruited at West Penn Hospital in Pittsburgh, PA in the days immediately following delivery. Treatment mothers were matched with volunteer mentors who communicated with them entirely via text messages. Control mothers received monthly one-way texts on basic safety topics. Measures were collected via hospital records and mother surveys. We estimated treatment effects on mothers' parenting stress, mental health, knowledge of child development, engagement in language and literacy activities, and child milestones at 4- and 18-months postpartum. We used a systematic coding approach and simple descriptive statistics to analyze the treatment mother-mentor texting transcripts. Results: We found no statistically significant impacts on targeted outcomes. However, impacts for some outcomes were meaningfully large (> 0.2 SDs). Analyses of texting transcripts showed that most mothers stayed engaged for the full 18-month study period and that mother-mentor pairs primarily discussed maternal wellbeing and child-focused topics. Conclusions for Practice: Postpartum mothers will engage with mentors in a text-based mentoring program around important maternal and child health topics. More research and development on technology-based supports for parents in the early childhood years is needed. Significance: What is already known on this subject? Technology-based approaches to supporting parents of young children are proliferating, with some showing promise in rigorous trials. What this study adds? Postpartum mothers will engage with mentors in text-based format and discuss maternal and child health topics. The efficacy of this approach should be tested further in larger trials. [ABSTRACT FROM AUTHOR]

The purpose of this investigation was to explore the effects of dietary weight loss intervention, with and without the addition of exercise on health-related quality of life, depressive symptoms, and anxiety. As part of the EMPOWER study for women, sixty premenopausal women (BMI of 40.4 ± 6.7) were randomized to energy restriction only (ER) or to exercise plus energy restriction (EXER) for 12 months. Health-related quality of life was assessed using the SF-36, depressive symptoms were assessed using the Beck Depression Inventory II (BDI), and anxiety symptoms using the Spielberger state and trait anxiety questionnaire. All measures were completed at baseline, 3, 6 and 12 months. At 12 months, there were significant (p < 0.05) group-by-time interactions favouring the EXER group for five of the eight domains and the mental component summary score. At 12 months, a significant group-by-time interaction favouring the EXER group is reported for both state and trait anxiety (p =.005 and p =.001, respectively). At 12 months, there was a significant group-by-time interaction for depressive symptoms favouring EXER (p < 0.05). Within-group changes for BDI scores were improved at all follow-up time points in the EXER group. Exercise training confers an additional benefit to energy restriction in the absence of additional weight loss at 12 months for health-related quality of life, depressive symptoms, and state and trait anxiety scores when compared to energy restriction only. Exercise and an energy-restricted diet improve health-related quality of life and mental health. Exercise may protect mental health without further weight loss for women with severe obesity. [ABSTRACT FROM AUTHOR]

Purpose: Diabetes remission is a phenomenon described in the context of drastic weight loss due to bariatric surgery or low-calorie diets. Evidence suggests that increasing the intake of plant protein could reduce the risk of type 2 diabetes. We sought for association between changes in plant protein intake in the context of 2 healthy diets without weight loss nor glucose-lowering medication, and diabetes remission in coronary heart disease patients from the CORDIOPREV study. Methods: Newly diagnosed type 2 diabetes participants without glucose-lowering treatment were randomized to consume a Mediterranean or a low-fat diet. Type 2 diabetes remission was assessed with a median follow-up of 60 months according to the ADA recommendation. Information on patient's dietary intake was collected using food-frequency questionnaires. At first year of intervention, 177 patients were classified according to changes in plant protein consumption into those who increased or decreased its intake, in order to perform an observational analysis on the association between protein intake and diabetes remission. Results: Cox regression showed that patients increasing plant protein intake were more likely to remit from diabetes than those who decreased its intake (HR = 1.71(1.05–2.77)). The remission occurred mainly at first and second year of follow-up with diminished number of patients achieving remission in the third year onwards. The increase in plant protein was associated with lower intake of animal protein, cholesterol, saturated fatty acids, and fat, and with higher intake of whole grains, fibre, carbohydrates, legumes, and tree nuts. Conclusion: These results support the need to increase protein intake of vegetal origin as dietary therapy to reverse type 2 diabetes in the context of healthy diets without weight loss. [ABSTRACT FROM AUTHOR]

Purpose Pain and stress-related ill-health are major causes of long-term disability and sick leave. This study evaluated the effects of a brief psychosocial program, which previously has been tested for an at-risk population of employees. Methods The Effective Communication within the Organization (ECO) program, where supervisors and employees were trained in communication and problem solving, was compared to an active control consisting of psychoeducative lectures (PE) about pain and stress in a cluster randomized controlled trial. First-line supervisors were randomized to ECO or PE, and a total of 191 mainly female employees with self-reported pain and/or stress-related ill-health were included. The hybrid format programs consisted of 2–3 group sessions. Sick leave data was collected from social insurance registers, before and 6-months after the program. Secondary outcomes (work ability, work limitations, pain-disability risk, exhaustion symptoms, perceived stress, perceived health, quality of life, perceived communication and support from supervisors) were assessed at baseline, post intervention, and at 6-months follow-up. Results No effects were observed on primary or secondary outcome variables. Pain symptoms were common (89%), however a lower proportion (30%) were identified as at risk for long-term pain disability, which might explain the lack of evident effects. The Covid-19 pandemic affected participation rates and delivery of intervention. Conclusion In this study, preventive effects of the ECO program were not supported. Altogether, the findings point at the importance of selecting participants for prevention based on screening of psychosocial risk. Further research on workplace communication and support, and impact on employee health is warranted. [ABSTRACT FROM AUTHOR]

Purpose Neck pain is common among office workers and leads to work productivity loss. This study aimed to investigate the effect of a multi-component intervention on neck pain-related work productivity loss among Swiss office workers. Methods Office workers, aged 18–65 years, and without serious neck-related health problems were recruited from two organisations for our stepped-wedge cluster randomized controlled trial. The 12-week multi-component intervention included neck exercises, health-promotion information, and workplace ergonomics. The primary outcome of neck pain-related work productivity loss was measured using the Work Productivity and Activity Impairment Questionnaire and expressed as percentages of working time. In addition, we reported the weekly monetary value of neck pain-related work productivity loss. Data was analysed on an intention-to-treat basis using a generalized linear mixed-effects model. Results Data from 120 participants were analysed with 517 observations. At baseline, the mean age was 43.7 years (SD 9.8 years), 71.7% of participants were female (N = 86), about 80% (N = 95) reported mild to moderate neck pain, and neck pain-related work productivity loss was 12% of working time (absenteeism: 1.2%, presenteeism: 10.8%). We found an effect of our multi-component intervention on neck pain-related work productivity loss, with a marginal predicted mean reduction of 2.8 percentage points (b = −0.27; 95% CI: −0.54 to −0.001, p = 0.049). Weekly saved costs were Swiss Francs 27.40 per participant. Conclusions: Our study provides evidence for the effectiveness of a multi-component intervention to reduce neck pain-related work productivity loss with implications for employers, employees, and policy makers. Trial Registration ClinicalTrials.gov, NCT04169646. Registered 15 November 2019—Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04169646. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the effect of an anti-inflammatory compared to a low-calorie diet on the physical and mental health of patients with knee OA. Methods: In this randomized parallel clinical trial, participants were selected among overweight and obese women aged 40 years or older with mild to moderate OA. Sixty women with a ratio of 1:1 were randomly assigned to receive either low-calorie or anti-inflammatory accompanied by a low-calorie diet for two months. The dietary intake and weight of participants were measured. Study variables were assessed using the Western Ontario and McMaster Index (WOMAC), visual analog pain scale (VAS), Beck Depression Inventory (BDI-II), Beck Anxiety Inventory (BAI-I), and the Short Form 36 Health Survey Questionnaire (SF-36) to indicate the quality of life (QoL). Results: There was no statistically significant difference between the two groups in demographic and baseline variables except for the emotional well-being subscale of QoL. There was significant difference in anti-inflammatory compared to low-calorie diet in terms of weight (MD (95% CI): − 4.02 kg (− 6.77 to − 1.28); p = 0.005), VAS (MD (95% CI): − 0.97 (− 1.53 to − 0.41); p = 0.001), WOMAC-total score (MD (95% CI): − 9.91 (− 15.05 to − 4.78); p < 0.001), WOMAC-pain subscale (MD (95% CI): − 3.30 (− 5.30 to − 1.29); p = 0.002), WOMAC-physical function (MD(95% CI): − 5.48 (− 9.41 to − 1.53); p = 0.007), depression (p = 0.003), anxiety (p = 0.011), QoL-physical functioning (0.041), and QoL-pain (0.010) after the intervention. Conclusion: An anti-inflammatory accompanied by a low-calorie diet resulted in greater weight loss and greater improvement in pain intensity, functional status, depression, anxiety, and some dimension of QoL in overweight and obese women with knee OA compared to the low-calorie diet. Trial registration number and date of registration: IRCT201610220030424N2; 2018-04-23. [ABSTRACT FROM AUTHOR]

Gamification, the application of gaming elements to increase enjoyment and engagement, has the potential to improve the effectiveness of digital health interventions, while the effectiveness of competition gamification components remains poorly understood on residency. To address this gap, we evaluate the effect of smartphone-based gamified team competition intervention on daily step count and sleep duration via a micro-randomized trial on medical interns. Our aim is to assess potential improvements in the factors (namely step count and sleep) that may help interns cope with stress and improve well-being. In 1779 interns, team competition intervention significantly increases the mean daily step count by 105.8 steps (SE 35.8, p = 0.03) relative to the no competition arm, while does not significantly affect the mean daily sleep minutes (p = 0.76). Moderator analyses indicate that the causal effects of competition on daily step count and sleep minutes decreased by 14.5 steps (SE 10.2, p = 0.16) and 1.9 minutes (SE 0.6, p = 0.003) for each additional week-in-study, respectively. Intra-institutional competition negatively moderates the causal effect of competition upon daily step count by −90.3 steps (SE 86.5, p = 0.30). Our results show that gamified team competition delivered via mobile app significantly increases daily physical activity which suggests that team competition can function as a mobile health intervention tool to increase short-term physical activity levels for medical interns. Future improvements in strategies of forming competition opponents and introducing occasional competition breaks may improve the overall effectiveness. [ABSTRACT FROM AUTHOR]

The need for effective intervention programs for youth with neurodevelopmental problems (ESSENCE) and challenging behaviour is great. This study examines Problem Resolution in ESSENCE (PR-ESSENCE), a newly developed model in which children and parents develop mutual problem resolution strategies. Ten-week randomized controlled trial of PR-ESSENCE for children and adolescents aged 5–18 years, compared to treatment as usual. Outcomes were assessed at baseline and randomized period endpoint. Primary outcome was the Clinical Global Impression—Improvement scale (CGI-I) rated by blinded assessors. Secondary outcomes were rated by parents—SNAP-IV, Eyberg Child Behavior Inventory (ECBI), Relationship Problems Questionnaire, Family Burden of Illness Module, and children—Beck Youth Inventories (BYI). ClinicalTrials.gov identifier: NCT03780413. The study enrolled 108 participants (active n = 72; controls n = 36, randomized 2:1), of whom 95 completed the randomized period. No clinically significant group differences were found in baseline characteristics. More than half had autism and 80% had ADD or ADHD. Large treatment effects were seen on CGI-I (ITT analysis, Effect Size 1.48). Treatment responders, much/very much improved on CGI-I, were 51.4% in active group and 5.6% of controls. Effect sizes were medium to large in parent ratings on SNAP-IV (ODD and ADHD symptoms), ECBI (behaviour problems), and in BYI child self-ratings of disruptive behaviour. PR-ESSENCE treatment improved global symptoms and functioning (CGI-I), behaviour problems, ADHD and ODD symptoms, and disruptive behaviour. Treatment effects were at least equivalent to those in previous studies of well-established Parent Management Training and Collaborative Problem Solving programs. [ABSTRACT FROM AUTHOR]

Background: Use of numerical and spatial language, also known as math talk, is critical to the development of foundational number and spatial skills in early childhood. However, caregivers and children of low socioeconomic status (SES) tend to use less math talk than their higher-SES peers. Objective: The current efficacy study tested the hypothesis that quantity of math talk among low-SES caregivers and children is increased via a caregiver education curriculum aimed at improving caregivers' language input to children. Methods: Caregiver-child dyads (n = 37; children aged 17 to 36 months) participated in either the language input or a control intervention. Math talk (operationalized as number and spatial word tokens) was coded from video recordings of each dyad engaging in free play at three time points: baseline, post-intervention, and follow-up. Results: The language input curriculum significantly increased caregivers' amount of spatial talk and cildren's amount of number and spatial talk for up to 4 months after the intervention. Conclusions: A caregiver education intervention increased caregivers' use of math talk, which resulted in higher math talk usage by their children. Further verification is needed through an adequately powered longitudinal randomized controlled trial. [ABSTRACT FROM AUTHOR]

Purpose In order to support people with low back pain (LBP) to stay at work, work arrangements are regarded important. This study aimed to evaluate the effectiveness of a workplace intervention using a participatory approach on work disability of workers with ongoing or recurrent LBP. Methods A total of 107 workers with LBP, with duration of pain for at least two consecutive weeks or recurrent pain of any duration during the last year, were randomized either to the intervention (n = 51) or control group (n = 56). The intervention included arrangements at the workplace, along with individual guidance provided by an occupational physiotherapist (OPT). The randomized intervention study used standard counselling and guidance by an OPT without workplace intervention as a comparison. Surveys were completed at baseline, and 6 and 12 months after baseline. Results There were no statistically significant differences between the intervention and control groups on the primary outcome measure, i.e. self-assessed work ability. We found no between-group differences in perceived health, self-assessed work productivity, number of sickness absence days and severity of back pain. However, there were significant positive within-group changes in the intervention group in the intensity of LBP, perceived health and the number of sickness absence days due to LBP. Conclusion Workplace arrangements are feasible using participatory ergonomics, but more quantitative and qualitative research is needed on its utilization and effectiveness among workers with LBP. [ABSTRACT FROM AUTHOR]

Purpose An increasing number of workers in the US have chronic health conditions that limit their ability to work, and few worksite interventions have been tested to improve worker coping and problem solving at work. The purpose of this study was to evaluate a worksite-based health self-management program designed to improve workplace function among workers with chronic health conditions. Methods We conducted a randomized, controlled trial of a worksite self-management program ("Manage at Work") (clinicaltrials.gov #NCT01978392) for workers with chronic health conditions (N = 119; 82% female, ages 20–69). Most workers were recruited from the health care or light manufacturing industry sectors. Workers attended a 5-session, facilitated psychoeducational program using concepts of health self-management, self-efficacy, ergonomics, and communication. Changes on outcomes of work engagement, work limitation, job satisfaction, work fatigue, work self-efficacy, days absent, and turnover intention at 6-month follow-up were compared to wait-list controls. Results The most prevalent chronic health conditions were musculoskeletal pain, headaches, vision problems, gastrointestinal disorders, respiratory disorders, and mental health disorders. The self-management program showed greater improvement in work engagement and turnover intent at 6-month follow-up, but there was no evidence of a parallel reduction in perceived work limitation. Trends for improved outcomes of work self-efficacy, job satisfaction, and work fatigue in the intervention group did not reach statistical significance in a group x time interaction test. Conclusions Offering a worksite self-management program to workers with chronic health conditions may be a feasible and beneficial strategy to engage and retain skilled workers who are risking disability. Clinical trial registration: Clinicaltrials.gov #NCT01978392. [ABSTRACT FROM AUTHOR]

Introduction: In a randomized controlled trial, we previously investigated if melanoma patients receiving checkpoint inhibitors had fewer severe immune-related adverse events (irAEs) when they reported symptoms using electronic patient-reported outcomes (ePRO) with triggered alerts as an add-on to standard care, compared to standard care alone. The aim of this study is to examine between-group differences in health-related quality of life (HRQoL) and associations between irAEs severity and HRQoL. Methods: The study population of 138 patients completed the EuroQol EQ-5D-5L Index and FACT-M questionnaires at baseline and weeks 24 and 48. We analyzed HRQoL from all patients who completed at least one questionnaire. Missing FACT-M items were imputed following existing guidelines. Results: There was no difference in HRQoL at baseline as measured EQ-5D-5L between the intervention and the control group. Between baseline and 48 weeks, mean EQ-5D-5L scores were unchanged among patients in the intervention group (p = 0.81) but decreased significantly among patients in the control group (p = 0.03). Consequently, patients in the intervention group had higher mean scores than those in the control group (p = 0.05) at 48 weeks. Mean FACT-M scores did not differ significantly between the two groups at any of the time points. There were observed no between-group differences in mean EQ-5D-5 and mean FACT-M scores between patients with severe irAEs and patients who had none. Conclusion: Melanoma patients receiving CPIs who self-reported irAEs using ePRO with triggered alerts as a supplement to standard care maintained their HRQoL compared to patients who received standard care alone. Patients in the intervention group had a significantly better HRQoL measured by EQ-5D-5L than controls 48 weeks after baseline. The results suggest that including ePRO in standard care increases melanoma patients´ well-being. Further and larger studies are needed to confirm this finding and examine the impact of severe irAEs on cancer patients' HRQoL. Trial registration: Clinicaltrials.gov NCT03073031 Registered 8 March 2017, Retrospectively registeredhttps://clinicaltrials.gov/. [ABSTRACT FROM AUTHOR]

African American and Hispanic women report less physical activity (PA) than non-Hispanic White women. As such, a digitally-enhanced 16-week social support pilot intervention was conducted to promote PA among African American and Hispanic women dyads. This study quantitatively and qualitatively examined the engagement and satisfaction of participants (N = 30; 15 dyads) assigned to the intervention. Intervention participants received telephone counseling calls based on motivational interviewing and a Jawbone UP activity monitor. Intervention engagement and satisfaction data were collected from the Jawbone UP, call logs, self-report questionnaires conducted at the 16-week follow-up, and two post-intervention focus groups. Nonparametric tests assessed group differences across engagement and satisfaction measures, and a manually-driven coding scheme was used to evaluate emerging themes from qualitative text. Participants demonstrated high engagement in the telephone counseling sessions and moderate engagement with the Jawbone UP. Friend/co-worker dyads and participants who were 45 years and older were more likely to use the device. Qualitative results emphasized participants' appreciation for the counseling calls, the Jawbone UP, and the overall dyadic framework of the study to collectively nurture social support and accountability for PA. Overall, the intervention group reacted positively to study components. Additional research is needed to understand the role of technology in facilitating long-lasting PA change via social support in minority populations. [ABSTRACT FROM AUTHOR]