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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]

Summary: We have developed a short, patient-reported outcome questionnaire-the Osteoporosis Assessment Questionnaire-Physical Function (OPAQ-PF)-that assesses the impact of osteoporosis on physical function. OPAQ-PF contains 15 items in three domains (mobility, physical positions, and transfers) and has content validity in osteoporosis patients with and without a history of fracture. Introduction: This paper describes the development of the Osteoporosis Assessment Questionnaire-Physical Function (OPAQ-PF), a patient-reported outcome (PRO) questionnaire based on OPAQ v.2.0 (60 items, 14 domains) that assesses the impact of osteoporosis on physical function. Methods: OPAQ v.2.0 was administered to patients with osteoporosis. Item response theory methodology and clinical judgment were used to retain/eliminate items. The resulting instrument was modified during two sets of concept elicitation and cognitive debriefing interviews with osteoporosis patients. Results: Item response theory-based analysis of OPAQ v.2.0 ( n = 1,478) coupled with clinician input resulted in the generation of a 21-item, six-domain instrument with a frequency response format. Interview data from 32 participants were used to modify this version and led to generation of the final instrument, OPAQ-PF. This final version has a severity response format and contains 15 items in three domains (mobility, physical positions, and transfers) that group together to provide an overall assessment of physical function in patients with osteoporosis. Twenty-two of the 32 interview participants (69 %) had previously sustained a fracture. Symptoms occurred primarily in these patients. Conclusions: OPAQ-PF represents a brief, focused, PRO instrument that assesses physical function in patients with osteoporosis, specifically related to mobility, physical positions, and transfers. This questionnaire has content validity in osteoporosis patients who have, and have not, sustained a prior fracture. [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 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]

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]

Background: Physical activity (PA) interventions in people with spinal cord injury (SCI) have been limited by a shortage of (1) evidence for sufficient increases in unsupervised PA to improve aerobic fitness and (2) stakeholder involvement in intervention design. Objectives: This study examined the effects of a theory-based PA intervention, developed in collaboration with nearly 300 stakeholders, on PA levels, aerobic fitness, and psychosocial predictors of PA among individuals with SCI. Methods: A randomized controlled trial (RCT) was conducted with 28 men and women with chronic SCI (age 45.0 ± 11.5 years, years post-injury 16.4 ± 12.4). Participants randomized to the intervention group (n = 14) received an introductory personal training session followed by eight weekly 15-min PA behavioral coaching sessions per week. PA was assessed using self-report and accelerometers. Aerobic fitness and psychosocial predictors of exercise were evaluated using an incremental exercise test and survey methods, respectively. Results: At post-intervention, controlling for baseline, the intervention group showed fivefold greater self-reported moderate to vigorous physical activity [mean difference 247.9 min/day; 95% confidence interval (CI) 92.8–403.1; p = 0.026, d = 1.04], 17% greater accelerometer-measured PA (mean difference 3.9 × 105 vector magnitude counts; 95% CI 1.1 × 104–7.7 × 105; p = 0.014, d = 0.31), and 19% higher peak oxygen uptake (VO2Peak; mean difference 0.23 L/min; 95% CI 0.12–0.33; p < 0.001, d = 0.54) compared with the control group. Mean values of psychosocial predictors of PA were also significantly improved in the intervention group compared with controls. Conclusion: To our knowledge, this co-created behavioral intervention produced the largest effect size to date for change in self-reported PA in an RCT involving people with physical disability. This is also the first RCT in people with SCI to demonstrate that a behavioral intervention can sufficiently increase unsupervised PA to improve aerobic fitness. Trial Registration: ClinicalTrials.gov, NCT03111030, 12 April 2017, https://clinicaltrials.gov/ct2/show/NCT03111030?term=NCT03111030&rank=1. [ABSTRACT FROM AUTHOR]

The Social Anxiety - Acceptance and Action Questionnaire (SA-AAQ; MacKenzie and Kocovski 2010) is a 19-item self-report measure designed to assess acceptance and action specific to social anxiety symptoms. The present research was designed to evaluate an abbreviated version of the SA-AAQ. This abbreviated scale was confirmed using an undergraduate sample ( N = 148) in Study 1 and a clinical sample of individuals with social anxiety disorder in Study 2 ( N = 137). Results indicated that an eight-item, two-factor model (acceptance and action) provided a good fit for the Brief SA-AAQ in both samples. Finally, we also found preliminary evidence in support of the convergent, discriminant/divergent, and incremental validity of the shortened scale. The Brief SA-AAQ shows promise as a useful and brief tool for the measurement of acceptance of social anxiety symptoms in socially anxious populations. [ABSTRACT FROM AUTHOR]

Purpose: Increased awareness of the importance of dietary fibre has led to increased interest in 'functional' fibre components like digestion-resistant maltodextrin (RMD). This randomized, placebo-controlled, double-blind study assessed the effects of RMD in the colonic transit time (CTT) and defecation characteristics (frequency, stool volume and consistency). Methods: Sixty-six healthy adult volunteers (32 men) who did not have a daily defecation habit had a 7-day run-in period before the 21-day intervention period with RMD or placebo. CTT and segmental CTT (SCTT) were assessed by a single abdominal X-ray film taken at the end of both periods after radiopaque marker ingestion. Defecation characteristics and intestinal functions were also assessed, which were self-reported by patients. Intragroup comparisons were evaluated by Student's paired t test, Bonferroni test and Chi-square test, while time comparisons by analysis of variance (ANOVA) and time-by-treatment interaction by repeated-measures ANOVA. Results: Fifty-seven subjects were assessed for CTT (placebo, n = 28; RMD, n = 29). In the RMD group, the total CTT, left SCTT and rectosigmoidal SCTT decreased significantly compared to baseline ( p < 0.01 each; −13.3, −4.7, −8.7 h, respectively). Significant differences between groups were observed in total CTT and left SCTT. Significant time-by-treatment interaction was observed in the RMD group for stool volume ( p = 0.014), increasing 56 % compared to baseline ( p < 0.01), while remained unchanged in the placebo group. Stool consistency was improved only in the RMD group ( p < 0.01). No adverse effects related to study products were observed. Conclusions: The results show that RMD improved CTT, stool volume, stool consistency and some intestinal functions in a healthy population. [ABSTRACT FROM AUTHOR]

Substantial evidence links antenatal depression, anxiety and stress with negative effects on foetal development, resulting in enduring problems in child development. Despite this, there is a paucity of research on intervention programmes designed to address depression and anxiety, and none that include infant outcomes. We aimed to evaluate the efficacy of a brief treatment for maternal depression and anxiety in pregnancy in a sample of women with a diagnosed depressive disorder. We developed a cognitive behavioural therapy treatment for antenatal depression and anxiety and evaluated it in a feasibility trial. This was followed by a pilot randomised controlled trial (RCT) which collected data on the efficacy of the brief intervention and follow-up data on infants. The feasibility study ( n = 25) yielded promising results for adherence, acceptability and improvements in depression and anxiety (Beck Depression Inventory and Beck Anxiety Inventory). The RCT ( n = 54) again showed excellent adherence and acceptability and supported the efficacy of the treatment. Strong reductions in anxiety were observed during pregnancy, and improvements in depression were maintained at 9 months representing a moderately large effect size. Nine-month infant outcomes showed several medium to large effects favouring the intervention in domains including problem solving, self-regulation and stress reactivity, which were independent of maternal postnatal mood. Treating severe depression and anxiety during pregnancy with a brief cognitive behavioural therapy (CBT) intervention appears feasible and worthwhile. To reliably detect clinically meaningful effects on infant outcomes, larger RCTs are likely to be required. [ABSTRACT FROM AUTHOR]

Purpose: The New Nordic Diet (NND) has induced weight loss in a 26-week controlled intervention. We aim to investigate whether high compliance and satisfaction can be maintained after the active intervention is discontinued thereby maintaining the health effects. Methods: After 26 weeks of intervention with NND or Average Danish Diet (ADD), 147 participants (mean age 43 years and mean BMI 29.1 kg/m) were followed for further 52 weeks. All participants were encouraged to follow NND but without further guidance. The study is registered with ClinicalTrials.gov, study id NCT01195610. Results: One hundred and ten participants (75 %) completed the follow-up. Among participants previously randomised to NND (NND group), dietary compliance and satisfaction decreased from 4.3 to 3.0 and from 4.8 to 4.0, respectively (both p < 0.0001) (1-5 point scale). Among those originally randomised to ADD (ADD group), satisfaction with NND was significantly higher than with ADD during follow-up (3.3 vs. 2.5, p = 0.026). Weight losses during intervention of −6.2 kg and −3.0 kg were followed by regains of 4.6 kg (SE 0.5) and 1.1 kg (SE 0.7) for the NND group and ADD group, respectively [adjusted difference; mean (95 % CI): 1.8 kg (0.1-3.4), p = 0.041]. Across diet groups, every 1 score higher in compliance with NND was associated with 0.90 kg less body weight regain ( p = 0.026) and those who increased physical activity regained 3.4 kg less compared to those who did not ( p < 0.0001). Conclusions: NND provides higher satisfaction, and body weight regain is reduced with higher compliance with NND and increased physical activity. [ABSTRACT FROM AUTHOR]

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Background: Irritable bowel syndrome (IBS) is a functional disorder of the lower gastrointestinal (GI) tract affected by stress, which may benefit from a biopsychosocial treatment approach such as mindfulness-based stress reduction (MBSR). Purpose: A treatment as usual (TAU) wait-list controlled trial was conducted in Calgary, Canada to investigate the impact of MBSR on IBS symptoms. It was hypothesized that MBSR patients would experience greater reduction in overall IBS symptom severity and self-reported symptoms of stress relative to control patients. Method: Ninety patients diagnosed with IBS using the Rome III criteria were randomized to either an immediate MBSR program ( n = 43) or to wait for the next available program ( n = 47). Patients completed IBS symptom severity, stress, mood, quality of life (QOL), and spirituality scales pre- and post-intervention or waiting period and at 6-month follow-up. Intent-to-treat linear mixed model analyses for repeated measures were conducted, followed by completers analyses. Results: While both groups exhibited a decrease in IBS symptom severity scores over time, the improvement in the MBSR group was greater than the controls and was clinically meaningful, with symptom severity decreasing from constantly to occasionally present. Pre- to post-intervention dropout rates of 44 and 23 % for the MBSR and control groups, respectively, were observed. At 6-month follow-up, the MBSR group maintained a clinically meaningful improvement in overall IBS symptoms compared to the wait-list group, who also improved marginally, resulting in no statistically significant differences between groups at follow-up. Improvements in overall mood, QOL, and spirituality were observed for both groups over time. Conclusions: The results of this trial provide preliminary evidence for the feasibility and efficacy of a mindfulness intervention for the reduction of IBS symptom severity and symptoms of stress and the maintenance of these improvements at 6 months post-intervention. Attention and self-monitoring and/or anticipation of MBSR participation may account for smaller improvements observed in TAU patients. [ABSTRACT FROM AUTHOR]

We analyzed data from a large randomized HIV/HCV prevention intervention trial with young injection drug users (IDUs) conducted in five U.S. cities. The trial compared a peer education intervention (PEI) with a time-matched, attention control group. Applying categorical latent variable analysis (mixture modeling) to baseline injection risk behavior data, we identified four distinct classes of injection-related HIV/HCV risk: low risk, non-syringe equipment-sharing, moderate-risk syringe-sharing, and high-risk syringe-sharing. The trial participation rate did not vary across classes. We conducted a latent transition analysis using trial baseline and 6-month follow-up data, to test the effect of the intervention on transitions to the low-risk class at follow-up. Adjusting for gender, age, and race/ethnicity, a significant intervention effect was found only for the high-risk class. Young IDU who exhibited high-risk behavior at baseline were 90 % more likely to be in the low-risk class at follow-up after the PEI intervention, compared to the control group. [ABSTRACT FROM AUTHOR]

Assertive Community Treatment (ACT) is an outreach-based case management model that assists people with severe mental illness through an intensive and integrated approach. In this program, a multidisciplinary team provides medical and psychosocial services. The purpose of this study was to examine the effectiveness of the following two ACT intervention strategies: 'replacement' (supporting the clients) versus 'backup' (supporting family members who provide care to clients). Admission days, psychiatric symptoms, quality of life, self-efficacy, and service satisfaction ware evaluated as outcome variables. To identify effective methods of supporting family members, clients living with family were divided into two groups based on the amount and types of services received-the backup group and the replacement group. ANCOVA was used to compare the outcomes between the two groups. The replacement group displayed significantly better psychiatric symptoms, social functioning, self-efficacy, and service satisfaction scores. No differences in admission days or quality of life were found. Clients provided more support directly to clients themselves than to family members was found to have better client outcomes in improving psychiatric symptoms, social functioning, and self-efficacy, resulting in higher levels of service satisfaction. This indicates that society should reduce the responsibility of the family and share responsibility for the care of people with mental illness to effectively improve outcomes for people with mental illnesses. [ABSTRACT FROM AUTHOR]

The study was conducted to examine the relative effectiveness of cognitive behavior therapy with a cultural tailoring intervention compared to brief medication management. The study used a two-arm randomized controlled trial in which participant assignment was stratified by gender. The intervention condition received eight weekly 40-min individualized counseling sessions of culturally tailored cognitive behavior therapy, while the control condition received eight weekly 10-min individualized counseling sessions of medication management. Both conditions received nicotine patches for 8 weeks. Data were collected at baseline and at four follow-up points (one and 4 weeks, and three and 6 months post-quit). Treatment outcomes were presented as an intention-to-treat analysis. Thirty Korean immigrants participated in the study. At 6-month follow-up, 57.1% of participants in the intervention and 18.8% of participants in the control had 7-day point prevalence abstinence (odds ratio = 5.8, 95% confidence interval = 1.12-26.04, P = 0.04). Participants' self-reported abstinence was biochemically verified with exhaled carbon monoxide and salivary cotinine levels. A combination of the culturally tailored cognitive behavior therapy and nicotine replacement therapy had a better treatment outcome compared to brief medication management. The promising result suggests a need to further test the intervention in larger samples and longer follow-up assessments before it can be adapted in clinical settings. [ABSTRACT FROM AUTHOR]

This study examined the mediated and moderated effects of a universal family-focused preventive intervention, delivered during young adolescence, on internalizing symptoms assessed in young adulthood. Sixth grade students ( N = 446; 52% female; 98% White) and their families from 22 rural Midwestern school districts were randomly assigned to the experimental conditions in 1993. Self-report questionnaires were administered at seven time points (pre-test to young adulthood-age 21) to those receiving the Iowa Strengthening Families Program (ISFP) and to the control group. Results showed that growth factors of adolescent internalizing symptoms (grades 6-12) were predicted by ISFP condition and risk status (defined as early substance initiation). Moderation of the condition effect by risk status was found, with higher-risk adolescents benefitting more from the ISFP. Results also supported the hypothesis that the ISFP's effect on internalizing symptoms in young adulthood was mediated through growth factors of adolescents' internalizing symptoms; risk moderation, however, was only marginally significant in young adulthood. The relative reduction rate on clinical or subclinical levels of young adult internalizing symptoms was 28%, indicating that for every 100 young adults displaying clinical or subclinical levels of internalizing symptoms from school districts not offering an intervention, there could be as few as 72 displaying those levels of symptoms in school districts that offered middle school prevention programming. These findings highlight how the positive effects of family-focused universal interventions can extend to non-targeted outcomes and the related potential public-health impact of scaling up these interventions. [ABSTRACT FROM AUTHOR]

Peer outreach models have been successful in addressing HIV risk behaviors of drug users. Patients in methadone maintenance treatment programs who were migrants from Puerto Rico and/or familiar with drug use there were trained to conduct HIV-related peer outreach. A group randomized design was implemented; patients in the Experimental (E) condition (n = 80) received training and conducted 12 weeks of outreach. Half of the patients completed the training and outreach. At follow-up, patients in the E condition who conducted outreach felt they were more helpful to their community, showed a trend for engaging in more vocational activities, and were more likely to talk with others about HIV, compared to those who did not conduct outreach and those in the Control condition (n = 78). Drug treatment patients who are migrants can be trained as peer outreach workers and short-term benefits were found. Longer term maintenance of benefits should be assessed. [ABSTRACT FROM AUTHOR]