Effect of peer support on prevention of postnatal depression among high risk women: multisite randomised controlled trial.

Science.gov (United States)

Dennis, C-L; Hodnett, E; Kenton, L; Weston, J; Zupancic, J; Stewart, D E; Kiss, A

2009-01-15

To evaluate the effectiveness of telephone based peer support in the prevention of postnatal depression. Multisite randomised controlled trial. Seven health regions across Ontario, Canada. 701 women in the first two weeks postpartum identified as high risk for postnatal depression with the Edinburgh postnatal depression scale and randomised with an internet based randomisation service. Proactive individualised telephone based peer (mother to mother) support, initiated within 48-72 hours of randomisation, provided by a volunteer recruited from the community who had previously experienced and recovered from self reported postnatal depression and attended a four hour training session. Edinburgh postnatal depression scale, structured clinical interview-depression, state-trait anxiety inventory, UCLA loneliness scale, and use of health services. After web based screening of 21 470 women, 701 (72%) eligible mothers were recruited. A blinded research nurse followed up more than 85% by telephone, including 613 at 12 weeks and 600 at 24 weeks postpartum. At 12 weeks, 14% (40/297) of women in the intervention group and 25% (78/315) in the control group had an Edinburgh postnatal depression scale score >12 (chi(2)=12.5, P<0.001; number need to treat 8.8, 95% confidence interval 5.9 to 19.6; relative risk reduction 0.46, 95% confidence interval 0.24 to 0.62). There was a positive trend in favour of the intervention group for maternal anxiety but not loneliness or use of health services. For ethical reasons, participants identified with clinical depression at 12 weeks were referred for treatment, resulting in no differences between groups at 24 weeks. Of the 221 women in the intervention group who received and evaluated their experience of peer support, over 80% were satisfied and would recommend this support to a friend. Telephone based peer support can be effective in preventing postnatal depression among women at high risk. ISRCTN 68337727.

Effectiveness of an online SUpport PRogramme (SUPR) for older hearing aid users: study protocol for a cluster randomised controlled trial.

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Meijerink, Janine Fj; Pronk, Marieke; Paulissen, Bernadette; Witte, Birgit I; Wouden, Bregje van der; Jansen, Vera; Kramer, Sophia E

2017-06-20

An educational SUpport PRogramme called SUPR has been developed for hearing aid users (HAUs) and their communication partners (CPs) offering care beyond hearing aid fitting. SUPR teaches its users communication strategies, hearing aid handling skills and personal adjustment to hearing impairment. Using a cluster randomised controlled trial design, 70 Dutch hearing aid dispenser practices were randomised into hearing aid fitting (care as usual, 34 practices) and hearing aid fitting including SUPR (36 practices). The aim was to recruit a total of 569 older (aged 50+ years) first-time (n=258) and experienced (n=311) HAUs and their CPs. SUPR consists of a Practical Support Booklet and online material offered via email over a period of 6-7 months. The booklet provides practical information on hearing aids, advice on communication strategies and home exercises. The online material consists of educational videos on hearing aid functionality and usage, communication strategies and peer testimonials. Finally, noncommittal email contact with the dispenser is offered. Every HAU is asked to assign a CP who is advised to be involved intensively. Effect measurements for HAUs and their CPs will occur at baseline and at 6, 12 and 18 months follow-up via online questionnaires. The primary outcomes for HAUs will be the use of communication strategies as measured by the subscales of the Communication Profile for the Hearing Impaired. A process evaluation will be performed. The study was approved by the Dutch Institutional Review Board of the VU Medical University Center Amsterdam. This intervention could contribute to lowering the hearing impairment burden in our ageing society. The results will be disseminated through peer-reviewed publications and scientific conferences. ISRCTN77340339; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly

Interventions for obtaining and maintaining employment in adults with severe mental illness, a network meta-analysis.

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Suijkerbuijk, Yvonne B; Schaafsma, Frederieke G; van Mechelen, Joost C; Ojajärvi, Anneli; Corbière, Marc; Anema, Johannes R

2017-09-12

People with severe mental illness show high rates of unemployment and work disability, however, they often have a desire to participate in employment. People with severe mental illness used to be placed in sheltered employment or were enrolled in prevocational training to facilitate transition to a competitive job. Now, there are also interventions focusing on rapid search for a competitive job, with ongoing support to keep the job, known as supported employment. Recently, there has been a growing interest in combining supported employment with other prevocational or psychiatric interventions. To assess the comparative effectiveness of various types of vocational rehabilitation interventions and to rank these interventions according to their effectiveness to facilitate competitive employment in adults with severe mental illness. In November 2016 we searched CENTRAL, MEDLINE, Embase, PsychINFO, and CINAHL, and reference lists of articles for randomised controlled trials and systematic reviews. We identified systematic reviews from which to extract randomised controlled trials. We included randomised controlled trials and cluster-randomised controlled trials evaluating the effect of interventions on obtaining competitive employment for adults with severe mental illness. We included trials with competitive employment outcomes. The main intervention groups were prevocational training programmes, transitional employment interventions, supported employment, supported employment augmented with other specific interventions, and psychiatric care only. Two authors independently identified trials, performed data extraction, including adverse events, and assessed trial quality. We performed direct meta-analyses and a network meta-analysis including measurements of the surface under the cumulative ranking curve (SUCRA). We assessed the quality of the evidence for outcomes within the network meta-analysis according to GRADE. We included 48 randomised controlled trials involving

Supportive text messages for patients with alcohol use disorder and a comorbid depression: a protocol for a single-blind randomised controlled aftercare trial.

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Hartnett, Dan; Murphy, Edel; Kehoe, Elizabeth; Agyapong, Vincent; McLoughlin, Declan M; Farren, Conor

2017-05-29

Alcohol use disorders (AUDs) and mood disorders commonly co-occur, and are associated with a range of negative outcomes for patients. Mobile phone technology has the potential to provide personalised support for such patients and potentially improve outcomes in this difficult-to-treat cohort. The aim of this study is to examine whether receiving supporting SMS text messages, following discharge from an inpatient dual diagnosis treatment programme, has a positive impact on mood and alcohol abstinence in patients with an AUD and a comorbid mood disorder. The present study is a single-blind randomised controlled trial. Patients aged 18-70 years who meet the criteria for both alcohol dependency syndrome/alcohol abuse and either major depressive disorder or bipolar disorder according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders IV Axis I will be randomised to receive twice-daily supportive SMS text messages for 6 months plus treatment as usual, or treatment as usual alone, and will be followed-up at 3, 6, 9 and 12 months postdischarge. Primary outcome measures will include changes from baseline in cumulative abstinence duration, which will be expressed as the proportion of days abstinent from alcohol in the preceding 90 days, and changes from baseline in Beck Depression Inventory scores. The trial has received full ethical approval from the St. Patrick's Hospital Research Ethics Committee (protocol 13/14). Results of the trial will be disseminated through peer-reviewed journal articles and at academic conferences. NCT02404662; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Profile of job coaches in supported employment

Directory of Open Access Journals (Sweden)

Esther MERCADO GARCÍA

2017-02-01

Full Text Available This study analyzes the figure of the job coach in various Supported Employment services in Spain. A quality-oriented study carried out, based on the case study. Twenty-three semi-structured interviews held with professionals, along with thirtysix participant observations at different stages of Supported Employment. The results show disparity in the profiles associated with various areas of knowledge, as well as a diversity of functions related to the roles performed by the job coach depending on the number of staff taken on. The most significant competencies combined with personal skills and communicative abilities. It recommended that employment programs improve vocational retraining programs to make up for training deficiencies and provide professional skills for intervention in each service.

Job maintenance by supported employment: an overview of the Supported Employment plus trial

Directory of Open Access Journals (Sweden)

Wolfram eKawohl

2015-05-01

Full Text Available The number of days of absence from work associated with mental illness has risen dramatically in the past ten years in Germany. Companies are challenged by this issue and seek help for the physical and mental health of their employees. Supported Employment concepts such as the Individual Placement and Support (IPS model have been designed to bring jobless persons with mental disorders back to work. In the randomized, controlled SEplus-trial a modified IPS-approach is tested concerning its ability to shorten times of sick leave of persons with mental distress or a mental disorder and to prevent them from losing their job. The trial is outlined in this study protocol.

Leisure Education in Supported Employment.

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Employment Opportunities, Inc., Raleigh, NC.

This manual provides a leisure education program for individuals with disabilities, to facilitate leisure functioning in their homes and communities. The program is first introduced to participants and families upon admission into supported employment and is designed to be facilitated by a training specialist or job coach. The program can be…

Cluster randomised controlled trial of a multicomponent intervention to support the implementation of policies and practices that promote healthier environments at junior sports clubs: study protocol.

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Milner, Sharin; Sherker, Shauna; Clinton-McHarg, Tara; Dray, Julia; Zukowski, Nadya; Gonzalez, Sharleen; Kingsland, Melanie; Ooi, Jia Ying; Murphy, Allan; Brooke, Daisy; Wiggers, John; Wolfenden, Luke

2018-01-23

A large proportion of children and adolescents participate in organised sport, making community sports clubs a promising setting to support healthy behaviours. To date, however, there have been few interventions conducted in junior sports clubs that have targeted health-promoting practices. The primary aim of this pilot study is to assess the potential effectiveness of an intervention to implement health-promoting policies and practices in junior sporting clubs targeting alcohol and tobacco practices, healthy food and beverage availability, and physical activity via participation in sport. A secondary outcome is to assess the impact of such strategies on child exposure to alcohol and tobacco use at the club, purchasing behaviours by/for children at the club canteen and child sports participation opportunities. The study will employ a cluster randomised controlled trial design and be conducted in metropolitan and regional areas of two Australian states. Randomisation will occur at the level of the football league. Community football clubs with over 40 junior players (players under 18 years) within each league will be eligible to participate. The intervention will be developed based on frameworks that consider the social, cultural and environmental factors that influence health behaviours. Intervention clubs will be supported to implement 16 practices targeting alcohol management, tobacco use, nutrition practices, new player recruitment activity, equal participation for players and the development of policies to support these practices. Trained research staff will collect outcome data via telephone interviews at baseline and follow-up. Interviews will be conducted with both club representatives and parents of junior players. The study has been approved by the University of Newcastle Human Research Ethics Committee (H-2013-0429). The results of the study will be disseminated via peer-reviewed publications and presentations at conferences. ACTRN12617001044314; Pre

A multicentre, randomised controlled, non-inferiority trial, comparing nasal high flow with nasal continuous positive airway pressure as primary support for newborn infants with early respiratory distress born in Australian non-tertiary special care nurseries (the HUNTER trial): study protocol.

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Manley, Brett J; Roberts, Calum T; Arnolda, Gaston R B; Wright, Ian M R; Owen, Louise S; Dalziel, Kim M; Foster, Jann P; Davis, Peter G; Buckmaster, Adam G

2017-06-23

Nasal high-flow (nHF) therapy is a popular mode of respiratory support for newborn infants. Evidence for nHF use is predominantly from neonatal intensive care units (NICUs). There are no randomised trials of nHF use in non-tertiary special care nurseries (SCNs). We hypothesise that nHF is non-inferior to nasal continuous positive airway pressure (CPAP) as primary support for newborn infants with respiratory distress, in the population cared for in non-tertiary SCNs. The HUNTER trial is an unblinded Australian multicentre, randomised, non-inferiority trial. Infants are eligible if born at a gestational age ≥31 weeks with birth weight ≥1200 g and admitted to a participating non-tertiary SCN, are 1 hour. Infants are randomised to treatment with either nHF or CPAP. The primary outcome is treatment failure within 72 hours of randomisation, as determined by objective oxygenation, apnoea or blood gas criteria or by a clinical decision that urgent intubation and mechanical ventilation, or transfer to a tertiary NICU, is required. Secondary outcomes include incidence of pneumothorax requiring drainage, duration of respiratory support, supplemental oxygen and hospitalisation, costs associated with hospital care, cost-effectiveness, parental stress and satisfaction and nursing workload. Multisite ethical approval for the study has been granted by The Royal Children's Hospital, Melbourne, Australia (Trial Reference No. 34222), and by each participating site. The trial is currently recruiting in eight centres in Victoria and New South Wales, Australia, with one previous site no longer recruiting. The trial results will be published in a peer-reviewed journal and will be presented at national and international conferences. Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614001203640; pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted

Who benefits from supported employment: a meta-analytic study.

LENUS (Irish Health Repository)

Campbell, Kikuko

2012-02-01

AIMS: This meta-analysis sought to identify which subgroups of clients with severe mental illness (SMI) benefited from evidence-based supported employment. METHODS: We used meta-analysis to pool the samples from 4 randomized controlled trials comparing the Individual Placement and Support (IPS) model of supported employment to well-regarded vocational approaches using stepwise models and brokered services. Meta-analysis was used to determine the magnitude of effects for IPS\\/control group differences within specific client subgroups (defined by 2 work history, 7 sociodemographic, and 8 clinical variables) on 3 competitive employment outcomes (obtaining a job, total weeks worked, and job tenure). RESULTS: The findings strongly favored IPS, with large effect sizes across all outcomes: 0.96 for job acquisition, 0.79 for total weeks worked, and 0.74 for job tenure. Overall, 90 (77%) of the 117 effect sizes calculated for the 39 subgroups exceeded 0.70, and all 117 favored IPS. CONCLUSIONS: IPS produces better competitive employment outcomes for persons with SMI than alternative vocational programs regardless of background demographic, clinical, and employment characteristics.

Dual Support in Contract Workers' Triangular Employment Relationships

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Buch, Robert; Kuvaas, Bard; Dysvik, Anders

2010-01-01

This study investigated the interplay between perceived investment in contract worker development by the "client" organization and contract workers' perceived organizational support from their temporary employment "agency." A study among 2021 contract workers from three temporary employment agencies in Norway showed that the…

Pragmatic randomised controlled trial of group psychoeducation versus group support in the maintenance of bipolar disorder

Directory of Open Access Journals (Sweden)

Roberts Christopher

2011-07-01

Full Text Available Abstract Background Non-didactically delivered curriculum based group psychoeducation has been shown to be more effective than both group support in a specialist mood disorder centre in Spain (with effects lasting up to five years, and treatment as usual in Australia. It is unclear whether the specific content and form of group psychoeducation is effective or the chance to meet and work collaboratively with other peers. The main objective of this trial is to determine whether curriculum based group psychoeducation is more clinically and cost effective than unstructured peer group support. Methods/design Single blind two centre cluster randomised controlled trial of 21 sessions group psychoeducation versus 21 sessions group peer support in adults with bipolar 1 or 2 disorder, not in current episode but relapsed in the previous two years. Individual randomisation is to either group at each site. The groups are carefully matched for the number and type of therapists, length and frequency of the interventions and overall aim of the groups but differ in content and style of delivery. The primary outcome is time to next bipolar episode with measures of the therapeutic process, barriers and drivers to the effective delivery of the interventions and economic analysis. Follow up is for 96 weeks after randomisation. Discussion The trial has features of both an efficacy and an effectiveness trial design. For generalisability in England it is set in routine public mental health practice with a high degree of expert patient involvement. Trial Registration ISRCTN62761948 Funding National Institute for Health Research, England.

A national campaign to finance supported employment.

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Hogan, Michael F; Drake, Robert E; Goldman, Howard H

2014-06-01

Medicaid is now the main payment source and financing mechanism for services for adults with serious mental illness. Services formerly paid with state mental health funds have been converted to Medicaid, lightening the burden on state budgets affected by recession and other factors. The change has allowed states to maintain community care and inpatient services (in general hospitals). Medicaid service benefits include clinic and inpatient care, case management, and some rehabilitation services. But using Medicaid to finance some high-priority services such as supported employment has proven difficult. Now critical changes in Medicaid under the Affordable Care Act allow states to amend their Medicaid State Plans to provide more flexible services to people with serious mental illness. Advocacy and support may be needed to encourage this step. A national campaign to finance supported employment would join various stakeholders in the field, including professional organizations, family and service user groups, and organizations representing service providers. The authors of this editorial pledge their energies to support this campaign. They present suggestions for a campaign, including building a coalition, goals and targets, and online resources.

Workplace Breastfeeding Support Varies by Employment Type: The Service Workplace Disadvantage.

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Snyder, Kailey; Hansen, Kelli; Brown, Sara; Portratz, Amy; White, Kate; Dinkel, Danae

The majority of women are returning to work full-time after childbirth, and support within their place of employment may influence intention and duration for breastfeeding, but more research is needed. Therefore, the purpose of this study was to explore the influence of employment type on breastfeeding duration upon return to work by examining informal (i.e., verbal encouragement) and direct (i.e., lactation space, flexible time) factors of support. This was a retrospective survey of women's returning-to-work experiences while breastfeeding. Survey contents included respondent demographics as well as questions surrounding perceptions of employer support, work environment, and goal/satisfaction regarding breastfeeding. Data were analyzed via crosstabs and chi-square goodness of fit tests. A total of 1,002 women completed the survey. Significant differences were seen across different employment types. Women within the professional/management industry were most likely to receive informal and direct support for breastfeeding upon return to work. Women within the service industry and production/transportation industry reported receiving the lowest levels of informal and direct support. Workplace support varies by employment type and women in the service and production/transportation industry appear to be at a disadvantage compared with other employment types. There is a need for more breastfeeding support programs to be developed that target specific workplace characteristics.

Evaluation of an employment program for people with mental illness using the Supported Employment Fidelity Scale.

Science.gov (United States)

Cocks, Errol; Boaden, Ross

2009-10-01

The Individual Placement and Support (IPS) model aims to achieve open employment for people with mental illness. The Supported Employment Fidelity Scale (SEFS) is a 15-item instrument that evaluates the extent to which a service follows the IPS principles of best practice. This paper describes the IPS model and an evaluation of a specialist employment program for people with mental illness using the SEFS. The SEFS enabled a quantitative assessment of service provision against the criteria of evidence-based practice principles. Data were collected from multiple sources. In addition, a literature review was conducted, and personnel engaged in implementation of the IPS model at other Australian employment programs were consulted. The program achieved a score of 59 of a possible 75 on the SEFS, which is described as fair supported employment. Analysis of the 15-scale items resulted in the identification of strengths, areas for further development, and a set of recommendations. The program was operating substantially in line with evidence-based practice principles and had considerable scope for further development. Issues arising from the evaluation, areas of applicability of the SEFS and the underlying literature, and implications for occupational therapy are highlighted.

The Effectiveness of Paid Services in Supporting Unpaid Carers' Employment in England.

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Pickard, Linda; King, Derek; Brimblecombe, Nicola; Knapp, Martin

2015-07-01

This paper explores the effectiveness of paid services in supporting unpaid carers' employment in England. There is currently a new emphasis in England on 'replacement care', or paid services for the cared-for person, as a means of supporting working carers. The international evidence on the effectiveness of paid services as a means of supporting carers' employment is inconclusive and does not relate specifically to England. The study reported here explores this issue using the 2009/10 Personal Social Services Survey of Adult Carers in England . The study finds a positive association between carers' employment and receipt of paid services by the cared-for person, controlling for covariates. It therefore gives support to the hypothesis that services for the cared-for person are effective in supporting carers' employment. Use of home care and a personal assistant are associated on their own with the employment of both men and women carers, while use of day care and meals-on-wheels are associated specifically with women's employment. Use of short-term breaks are associated with carers' employment when combined with other services. The paper supports the emphasis in English social policy on paid services as a means of supporting working carers, but questions the use of the term 'replacement care' and the emphasis on 'the market'.

Supporting Workplace Diversity: Emerging Roles for Employment Counselors

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Neault, Roberta A.; Mondair, Suneet

2011-01-01

Employment counselors generally understand the benefits of workplace diversity; most are actively engaged in supporting diverse clients to attach to the workforce. However, they are less likely to be involved in supporting organizations to create workplaces where diverse workers are welcomed, appreciated, and fully engaged. In this article,…

Employer-Based Programs to Support Breastfeeding Among Working Mothers: A Systematic Review.

Science.gov (United States)

Dinour, Lauren M; Szaro, Jacalyn M

2017-04-01

Many mothers experience barriers to maintaining a breastfeeding relationship with their infants upon returning to work and, consequently, terminate breastfeeding earlier than recommended or intended. As such, employers are in a unique position to help further increase breastfeeding rates, durations, and exclusivity. The purpose of this review is to examine the literature regarding employer-based programs, policies, and interventions to support breastfeeding among working mothers. A systematic literature search was conducted for peer-reviewed articles published before April 2016. Studies were included if they focused on workplace-based lactation/breastfeeding support programs, policies, or interventions to promote breastfeeding among employees. For inclusion, articles must have measured at least one outcome, such as breastfeeding duration, breastfeeding exclusivity, or employee satisfaction. Twenty-two articles were included, representing 10 different countries and both public- and private-sector employers, including governmental offices, schools, hospitals, manufacturing/industrial companies, and financial settings, among others. Providing a lactation space was the most common employer-based support accommodation studied, followed by breastfeeding breaks and comprehensive lactation support programs. The majority of studies analyzing these three support types found at least one positive breastfeeding and/or nonbreastfeeding outcome. This review suggests that maintaining breastfeeding while working is not only possible but also more likely when employers provide the supports that women need to do so. Although some employers may have more extensive breastfeeding support policies and practices than others, all employers can implement a breastfeeding support program that fits their company's budget and resources.

Supported employment for persons with serious mental illness: current status and future directions.

Science.gov (United States)

Mueser, K T; McGurk, S R

2014-06-01

The individual placement and supported (IPS) model of supported employment is the most empirically validated model of vocational rehabilitation for persons with schizophrenia or another serious mental illness. Over 18 randomized controlled trials have been conducted throughout the world demonstrating the effectiveness of supported employment at improving competitive work compared to other vocational programs: IPS supported employment is defined by the following principles: 1) inclusion of all clients who want to work; 2) integration of vocational and clinical services; 3) focus on competitive employment; 4) rapid job search and no required prevocational skills training; 5) job development by the employment specialist; 6) attention to client preferences about desired work and disclosure of mental illness to prospective employers; 7) benefits counseling; and 8) follow-along supports after a job is obtained. Supported employment has been successfully implemented in a wide range of cultural and clinical populations, although challenges to implementation are also encountered. Common challenges are related to problems such as the failure to access technical assistance, system issues, negative beliefs and attitudes of providers, funding restrictions, and poor leadership. These challenges can be overcome by tapping expertise in IPS supported employment, including standardized and tested models of training and consultation. Efforts are underway to increase the efficiency of training methods for supported employment and the overall program, and to improve its effectiveness for those clients who do not benefit. Progress in IPS supported employment offers people with a serious mental illness realistic hope for achieving their work goals, and taking greater control over their lives. Copyright © 2014. Published by Elsevier Masson SAS.

Job Endings and Work Trajectories of Persons Receiving Supported Employment and Cognitive Remediation.

Science.gov (United States)

Teixeira, Carina; Mueser, Kim T; Rogers, E Sally; McGurk, Susan R

2018-05-02

This study examined job endings and work trajectories among participants in a study comparing the effects of adding cognitive remediation to supported employment among individuals who had not benefited from supported employment. Data were from a controlled trial of 107 persons with serious mental illness enrolled in supported employment but who had not obtained or sustained competitive work. Participants were randomly assigned to enhanced supported employment only (with employment specialists trained to recognize cognitive difficulties and teach coping strategies) or to the Thinking Skills for Work program (enhanced supported employment plus cognitive remediation). For the 52 participants who worked, the two groups were compared on types of job endings, reasons for job endings, successful versus unsuccessful jobs, and work trajectories over the two-year study period. The two groups did not differ in types of job ending, although participants in Thinking Skills for Work were less likely than those in enhanced supported employment only to cite dissatisfaction with the job as a reason for the job ending. Participants in Thinking Skills for Work were also less likely to have an overall unsuccessful work trajectory, more likely to have only successful jobs, and more likely to be employed at the end of the study. The Thinking Skills for Work program appeared to help participants who had not benefited from supported employment stick with and master their jobs more effectively than those in enhanced supported employment only, resulting in better work trajectories over the course of the study.

Supported Employment in Connecticut: An Examination of Integration and Wage Outcomes.

Science.gov (United States)

Helms, Barbara L.; And Others

1991-01-01

Study of a sample of 93 individuals with disabilities participating in supported employment programs in Connecticut found that monthly wages and levels of integration increased significantly when compared to working situations prior to supported employment placement. (JDD)

The effectiveness of skills training for improving outcomes in supported employment.

Science.gov (United States)

Mueser, Kim T; Aalto, Steve; Becker, Deborah R; Ogden, John S; Wolfe, Rosemarie S; Schiavo, Diane; Wallace, Charles J; Xie, Haiyi

2005-10-01

This study evaluated whether a supplementary skills training program improved work outcomes for clients enrolled in supported employment programs. Thirty-five recently employed clients with severe mental illness who were receiving supported employment services at a free-standing agency were randomly assigned to participate in either the workplace fundamentals program, a skills training program designed to make work more "successful and satisfying," or treatment as usual. Knowledge of workplace fundamentals (for example, identifying workplace stressors, problem solving, and improving job performance) was assessed at baseline and at nine months; employment outcomes and use of additional vocational services were tracked for 18 months. Clients in the workplace fundamentals group (N=17) improved more in knowledge of workplace fundamentals than those in the control group (N=18) at the nine-month follow-up, but the two groups did not differ in the number of hours or days worked, salary earned, or receipt of additional vocational services over the 18-month period. In general, clients in this study had higher educational levels and better employment outcomes than clients in most previous studies of supported employment, making it difficult to detect possible effects of the skills training intervention on work. Supplementary skills training did not improve work outcomes for clients who were receiving supported employment.

A randomised controlled trial to prevent smoking relapse among recently quit smokers enrolled in employer and health plan sponsored quitlines.

Science.gov (United States)

McDaniel, Anna M; Vickerman, Katrina A; Stump, Timothy E; Monahan, Patrick O; Fellows, Jeffrey L; Weaver, Michael T; Carlini, Beatriz H; Champion, Victoria L; Zbikowski, Susan M

2015-06-29

To test adding an interactive voice response (IVR)-supported protocol to standard quitline treatment to prevent relapse among recently quit smokers. Parallel randomised controlled trial with three arms: standard quitline, standard plus technology enhanced quitline with 10 risk assessments (TEQ-10), standard plus 20 TEQ assessments (TEQ-20). Quit For Life (QFL) programme. 1785 QFL enrolees through 19 employers or health plans who were 24+ h quit. QFL is a 5-call telephone-based cessation programme including medications and web-based support. TEQ interventions included 10 or 20 IVR-delivered relapse risk assessments over 8 weeks with automated transfer to counselling for those at risk. Self-reported 7-day and 30-day abstinence assessed at 6-month and 12-month post-enrolment (response rates: 61% and 59%, respectively). Missing data were imputed. 1785 were randomised (standard n=592, TEQ-10 n=602, TEQ-20 n=591). Multiple imputation-derived, intent-to-treat 30-day quit rates (95% CI) at 6 months were 59.4% (53.7% to 63.8%) for standard, 62.3% (57.7% to 66.9%) for TEQ-10, 59.4% (53.7% to 65.1%) for TEQ-20 and 30-day quit rates at 12 months were 61.2% (55.6% to 66.8%) for standard, 60.6% (56.0% to 65.2%) for TEQ-10, 54.9% (49.0% to 60.9%) for TEQ-20. There were no significant differences in quit rates. 73.3% of TEQ participants were identified as at-risk by IVR assessments; on average, participants completed 0.41 IVR-transferred counselling calls. Positive risk assessments identified participants less likely (OR=0.56, 95% CI 0.42 to 0.76) to be abstinent at 6 months. Standard treatment was highly effective, with 61% remaining abstinent at 12 months using multiple imputation intent-to-treat (intent-to-treat missing=smoking quit rate: 38%). TEQ assessments identified quitters at risk for relapse. However, adding IVR-transferred counselling did not yield higher quit rates. Research is needed to determine if alternative designs can improve outcomes. NCT00888992. Published by

Approach to cost-benefit analysis between supported employment and special employment centers through comparative simulation with 24 workers

Directory of Open Access Journals (Sweden)

Francisco de Borja Jordán de Urríes Vega

2014-06-01

Full Text Available This work presents a cost-benefit analysis comparing supported employment (SE with special employment center (EEC, from an individual, corporate and society perspective. A simulation was carried out with a sample of 24 workers in regular employment by SE and hypothetical data were obtained for the same workers as if they were in a similar job in EEC. The results show that SE workers, working the same amount of hours, have higher hourly earnings than in EEC (9.22 € compared to 4.59 €. The SE also generates less social burden from the company (22.21 % than EEC (85.54 %. The Supported Employment’s payoff for society is much higher (315.03% than that of the EEC (83.14%. Therefore, the conclusions of the study are directed towards the consideration that supported employment is more beneficial in terms of cost benefit for the individual, business and society when compared to the special employment centers.

Working women making it work: intimate partner violence, employment, and workplace support.

Science.gov (United States)

Swanberg, Jennifer; Macke, Caroline; Logan, T K

2007-03-01

Partner violence may have significant consequences on women's employment, yet limited information is available about how women cope on the job with perpetrators' tactics and the consequences of her coping methods on employment status. This article investigates whether there is an association between workplace disclosure of victimization and current employment status; and whether there is an association between receiving workplace support and current employment status among women who disclosed victimization circumstances to someone at work. Using a sample of partner victimized women who were employed within the past year (N = 485), cross-tabulation and ANOVA procedures were conducted to examine the differences between currently employed and unemployed women. Binary logistic regressions were conducted to examine whether disclosure and receiving workplace support were significantly associated with current employment. Results indicate that disclosure and workplace support are associated with employment. Implications for clinical practice, workplace policies, and future research are discussed.

Supplementing supported employment with workplace skills training.

Science.gov (United States)

Wallace, Charles J; Tauber, Robert

2004-05-01

Introduction by the column editors: Supported employment, as designed for persons with serious and persistent mental illness, has been termed individual placement and support. In two randomized controlled trials (1,2), clients who received individual placement and support services were more likely to obtain at least one job in the competitive sector, to work more hours, and to have a higher total income than their counterparts who received more traditional types of vocational rehabilitation. However, individual placement and support did not improve the length of time the employed participants kept their jobs. An adjunctive or additional element of individual placement and support, aimed at improving the job tenure of individuals with mental illness, would be a constructive contribution to the vocational rehabilitation for this population. In a previous Rehab Rounds column, Wallace and colleagues (3) described the development of the workplace fundamental skills module, a highly structured and user-friendly curriculum designed to teach workers with mental illness the social and workplace skills needed to keep their jobs. The workplace fundamental skills module supplements individual placement and support by conveying specific skills that enable workers to learn the requirements of their jobs, anticipate the stressors associated with their jobs, and cope with stressors by using a problem-solving process. The earlier report described the production and validation of the module's content. The purpose of this month's column is to present the preliminary results of a randomized comparison of the module's effects on job retention, symptoms, and community functioning when coupled with individual placement and support. To enable wide generalization of the findings of the study, the program was conducted in a typical community mental health center.

Acute pancreatitis: recent advances through randomised trials.

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van Dijk, Sven M; Hallensleben, Nora D L; van Santvoort, Hjalmar C; Fockens, Paul; van Goor, Harry; Bruno, Marco J; Besselink, Marc G

2017-11-01

Acute pancreatitis is one of the most common GI conditions requiring acute hospitalisation and has a rising incidence. In recent years, important insights on the management of acute pancreatitis have been obtained through numerous randomised controlled trials. Based on this evidence, the treatment of acute pancreatitis has gradually developed towards a tailored, multidisciplinary effort, with distinctive roles for gastroenterologists, radiologists and surgeons. This review summarises how to diagnose, classify and manage patients with acute pancreatitis, emphasising the evidence obtained through randomised controlled trials. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Study protocol: The development of a pilot study employing a randomised controlled design to investigate the feasibility and effects of a peer support program following discharge from a specialist first-episode psychosis treatment centre

Directory of Open Access Journals (Sweden)

Francey Shona

2010-05-01

Full Text Available Abstract Background Young people with first-episode psychosis (FEP are at risk of a range of negative outcomes. Specialist FEP services have been developed to provide comprehensive, multi-disciplinary treatment. However, these services are often available for a restricted period and the services that young people may be transferred to are less comprehensive. This represents a risk of drop out from treatment services in a group already considered to be at risk of disengagement. Peer support groups have been shown to improve social relationships among people with psychosis however individual peer support programs have not been tested on young people with first-episode psychosis; nor have they been tested at the point of discharge from services. Methods/design The study is an 18-month randomised controlled trial being conducted at Orygen Youth Health Research Centre in Melbourne, Australia. The aim of the study is to test the feasibility and effects of a 6-month peer support intervention delivered to young people with FEP over the period of discharge. Participants are young people aged 15-24 who are being discharged from a specialist first-episode psychosis treatment centre. There is a 6-month recruitment period. The intervention comprises two hours of contact per fortnight during which peer support workers can assist participants to engage with their new services, or other social and community activities. Participants will be assessed at baseline and post intervention (6 months. Discussion This paper describes the development of a randomised-controlled trial which aims to pilot a peer support program among young people who are being discharged from a specialist FEP treatment centre. If effective, the intervention could lead to benefits not only for participants over the discharge period, but for peer support workers as well. Trial registration The study was registered with the Australian New Zealand Clinical Trials Registry; number: ACTRN

Computerised therapy for depression with clinician vs. assistant and brief vs. extended phone support: study protocol for a randomised controlled trial

Directory of Open Access Journals (Sweden)

Gega Lina

2012-08-01

Full Text Available Abstract Background Computerised cognitive behaviour therapy (cCBT involves standardised, automated, interactive self-help programmes delivered via a computer. Randomised controlled trials (RCTs and observational studies have shown than cCBT reduces depressive symptoms as much as face-to-face therapy and more than waiting lists or treatment as usual. cCBT’s efficacy and acceptability may be influenced by the “human” support offered as an adjunct to it, which can vary in duration and can be offered by people with different levels of training and expertise. Methods/design This is a two-by-two factorial RCT investigating the effectiveness, cost-effectiveness and acceptability of cCBT supplemented with 12 weekly phone support sessions are either brief (5–10 min or extended (20–30 min and are offered by either an expert clinician or an assistant with no clinical training. Adults with non-suicidal depression in primary care can self-refer into the study by completing and posting to the research team a standardised questionnaire. Following an assessment interview, eligible referrals have access to an 8-session cCBT programme called Beating the Blues and are randomised to one of four types of support: brief-assistant, extended-assistant, brief-clinician or extended-clinician. A sample size of 35 per group (total 140 is sufficient to detect a moderate effect size with 90% power on our primary outcome measure (Work and Social Adjustment Scale; assuming a 30% attrition rate, 200 patients will be randomised. Secondary outcome measures include the Beck Depression and Anxiety Inventories and the PHQ-9 and GAD-7. Data on clinical outcomes, treatment usage and patient experiences are collected in three ways: by post via self-report questionnaires at week 0 (randomisation and at weeks 12 and 24 post-randomisation; electronically by the cCBT system every time patients log-in; by phone during assessments, support sessions and exit interviews. Discussion

Computerised therapy for depression with clinician vs. assistant and brief vs. extended phone support: study protocol for a randomised controlled trial.

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Gega, Lina; Swift, Louise; Barton, Garry; Todd, Gillian; Reeve, Nesta; Bird, Kelly; Holland, Richard; Howe, Amanda; Wilson, Jon; Molle, Jo

2012-08-27

Computerised cognitive behaviour therapy (cCBT) involves standardised, automated, interactive self-help programmes delivered via a computer. Randomised controlled trials (RCTs) and observational studies have shown than cCBT reduces depressive symptoms as much as face-to-face therapy and more than waiting lists or treatment as usual. cCBT's efficacy and acceptability may be influenced by the "human" support offered as an adjunct to it, which can vary in duration and can be offered by people with different levels of training and expertise. This is a two-by-two factorial RCT investigating the effectiveness, cost-effectiveness and acceptability of cCBT supplemented with 12 weekly phone support sessions are either brief (5-10 min) or extended (20-30 min) and are offered by either an expert clinician or an assistant with no clinical training. Adults with non-suicidal depression in primary care can self-refer into the study by completing and posting to the research team a standardised questionnaire. Following an assessment interview, eligible referrals have access to an 8-session cCBT programme called Beating the Blues and are randomised to one of four types of support: brief-assistant, extended-assistant, brief-clinician or extended-clinician.A sample size of 35 per group (total 140) is sufficient to detect a moderate effect size with 90% power on our primary outcome measure (Work and Social Adjustment Scale); assuming a 30% attrition rate, 200 patients will be randomised. Secondary outcome measures include the Beck Depression and Anxiety Inventories and the PHQ-9 and GAD-7. Data on clinical outcomes, treatment usage and patient experiences are collected in three ways: by post via self-report questionnaires at week 0 (randomisation) and at weeks 12 and 24 post-randomisation; electronically by the cCBT system every time patients log-in; by phone during assessments, support sessions and exit interviews. The study's factorial design increases its efficiency by allowing the

Social Security And Mental Illness: Reducing Disability With Supported Employment

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Drake, Robert E.; Skinner, Jonathan S.; Bond, Gary R.; Goldman, Howard H.

2010-01-01

Social Security Administration disability programs are expensive, growing, and headed toward bankruptcy. People with psychiatric disabilities now constitute the largest and most rapidly expanding subgroup of program beneficiaries. Evidence-based supported employment is a well-defined, rigorously tested service model that helps people with psychiatric disabilities obtain and succeed in competitive employment. Providing evidence-based supported employment and mental health services to this population could reduce the growing rates of disability and enable those already disabled to contribute positively to the workforce and to their own welfare, at little or no cost (and, depending on assumptions, a possible savings) to the government. PMID:19414885

Separation from supported employment: a retrospective chart review study.

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West, Michael; Targett, Pamela; Wehman, Paul; Cifu, Gabriella; Davis, Jacob

2015-01-01

The objective of this study was to examine job separations from supported employment (SE). The aim was to identify the types and nature of separations and precipitating events leading to the separation. A retrospective chart review methodology was utilized. The study was conducted in a metropolitan area in the Southeast United States by a university-based SE program. Participants were 47 SE clients who had been placed into and separated from 67 jobs. Using a coding form, information regarding the type of separation and issues that preceded the separation were recorded. Data were aggregated using descriptive statistics. The largest number of separations was due to termination, followed by resignation and mutual consent of the employer and employee. The mean number of issues leading to the separation was 2.2, ranging from one to five. Only eight positive issues were found (compared to 116 negative and 20 neutral), the most prevalent being entry into an educational or training program. Common negative issues included poor work performance, attendance and punctuality problems, conflicts with the supervisor, and social and behavioral issues. The findings of this study illustrate the need to address job retention issues during the job development process, finding the most appropriate person-job fit and workplace culture for each client. The findings also support the need for vigilant and regular communication between the SE program and employers to intervene quickly when problems arise. Separation from Supported Employment (SE) SE is an evidence-based employment practice that has been shown effective across multiple disability groups. Studying job separations can provide valuable information for improving service. Locating the best person-job fit, as well as frequent contract with employers, can help prevent unnecessary job loss.

Supported Employment Improves Cognitive Performance in Adults with Autism

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Garca-Villamisar, D.; Hughes, C.

2007-01-01

Background: The purpose of this study was to examine the effects of a supported employment programme on measures of executive functions for 44 adults with autism, assessed at the beginning and the end of the programme period. The average length of time of the community employment was 30 months. Methods: Based on their predominant work activity…

Employer support for innovative work and employees' job satisfaction and job-related stress.

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Raykov, Milosh

2014-01-01

There are high levels of global and national underemployment, but limited information is available on the impact of this phenomenon on the quality of employees' working lives. This study examines the relations among perceived employer support for creative work, different forms of underemployment and employee quality of life, including job satisfaction, perceived job security and job satisfaction. The study was performed using cross-sectional data from the Canadian 2010 Work and Lifelong Learning Survey (WALL), which included 1,042 randomly selected currently employed participants between the ages of 18 and 64 years of age. The study found a significant inverse association between employer support for innovative work and different forms of underemployment. It also suggested a strong relationship between support for such work and participation in work-related informal learning. The results from this study confirmed the hypothesis that employer support for creative work is significantly associated with the quality of employees' working lives, as manifested through increased job security and job satisfaction. Employees experiencing greater support for workplace creativity report less job-related stress. The present study identified relatively low employer support for creative work and significant differences in the perception of support among managers and workers. The results of this study indicate that employer support for innovative work can mitigate significant underutilization of employee knowledge and skills. Such support can contribute to the reduction of job-related stress, increased job satisfaction and perceived job security. This kind of support can also improve the quality of life of employees and facilitate creativity and overall organizational and social development.

Why can't we fund supported employment?

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Mueser, Kim T; Cook, Judith A

2016-06-01

Work is one of the most valued social rules in modern society, contributing to a person's sense of economic well-being, self-esteem, personal identity, and social status. Conversely, the inability to work or sustain employment due to a psychiatric condition is the primary factor in determining eligibility for disability benefits, such as Social Security Disability Income or Social Security Supplemental Income. Just as work is valued strongly by society, it is also important to people with serious mental illness. In this editorial, we contemplate why we cannot "do the right thing" and fully fund supported employment for persons with serious mental illness. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Employer-provided support services and job dissatisfaction in Canadian registered nurses.

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Wilkins, Kathryn; Shields, Margot

2012-10-01

Previous research indicates that nurses' job dissatisfaction relates to their work organization and environment; rarely has the contribution of employer provided support services been examined while controlling for the influence of other factors. The objective of this study was to examine job dissatisfaction among Canadian registered nurses in relation to employer-provided programs for child care and fitness or recreation. Data are from 2,993 respondents to the 2005 National Survey of the Work and Health of Nurses, weighted to represent Canada's 91,600 registered nurses in full-time, permanent positions who deliver direct care in hospitals or long-term care facilities. Multivariate modeling was used to examine job dissatisfaction in relation to employer-provided support programs, controlling for personal characteristics and variables reflecting work organization and the work environment. Employer-provided child care assistance programs were available to 16% of nurses, and fitness or recreation programs were available to 38%. An estimated 13% of nurses were dissatisfied with their jobs. Even when controlling for personal characteristics, overtime, shift work, shift length, weekly hours, overload, staffing inadequacy, autonomy, nurse-physician relations, and coworker respect, inverse associations with job dissatisfaction emerged for employer-supported child care (odds ratio = 0.49, 95% confidence interval = 0.27-0.88) and fitness programs (odds ratio = 0.65, 95% confidence interval = 0.42-0.99). This study provides new information suggesting that employer-provided support programs are protective against nurses' job dissatisfaction. This is a key finding in view of nursing shortages and the importance of job satisfaction to retention.

Supporting lifelong competence development and employability using TENCompetence services

NARCIS (Netherlands)

Manderveld, Jocelyn; Griffiths, Dai; Kew, Chris; Krekels, Bas

2009-01-01

Manderveld, J., Griffiths, D., Kew, C., & Krekels, B. (2008). Supporting lifelong competence development and employability using TENCompetence services. Presentation at Online Educa Berlin, December, 3, 2008, Berlin, Germany.

Implementation of evidence-based supported employment in regional Australia.

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Morris, Adrienne; Waghorn, Geoffrey; Robson, Emma; Moore, Lyndell; Edwards, Emma

2014-06-01

To implement the Individual Placement and Support (IPS) approach at 4 locations in regional New South Wales, Australia. Outcomes attained were compared with a national non-IPS program and with international trials of IPS within and outside the United States. Four IPS programs were established through formal partnerships between mental health services and disability employment services. Ninety-five mental health service clients commenced employment assistance and were tracked for a minimum of 12 months. Two sites achieved good fidelity to IPS principles, and 2 sites achieved fair fidelity. IPS clients had 3.5 times greater odds of attaining 13 weeks' employment than those receiving assistance in the national network of disability employment services. Implementing IPS is challenging in the Australian service delivery context. Factors other than program fidelity appear to contribute to excellent employment outcomes. Further research is needed to identify these factors.

Employer-Supported Training in Australia: Participation, Demand and Supply. NCVER Technical Report

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Shah, Chandra

2017-01-01

This report provides an analysis of employer-supported training in Australia. Employer-supported training is the largest share of adult education and training in all Organisation for Economic Co-operation and Development (OECD) countries. It has benefits for individuals, firms, and society. Cross-country studies have shown a positive association…

Lay support for pregnant women with social risk: a randomised controlled trial

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Kenyon, Sara; Jolly, Kate; Hemming, Karla; Hope, Lucy; Blissett, Jackie; Dann, Sophie-Anna; Lilford, Richard; MacArthur, Christine

2016-01-01

Objectives We sought evidence of effectiveness of lay support to improve maternal and child outcomes in disadvantaged families. Design Prospective, pragmatic, individually randomised controlled trial. Setting 3 Maternity Trusts in West Midlands, UK. Participants Following routine midwife systematic assessment of social risk factors, 1324 nulliparous women were assigned, using telephone randomisation, to standard maternity care, or addition of referral to a Pregnancy Outreach Worker (POW) service. Those under 16 years and teenagers recruited to the Family Nurse Partnership trial were excluded. Interventions POWs were trained to provide individual support and case management for the women including home visiting from randomisation to 6 weeks after birth. Standard maternity care (control) included provision for referring women with social risk factors to specialist midwifery services, available to both arms. Main outcome measures Primary outcomes were antenatal visits attended and Edinburgh Postnatal Depression Scale (EPDS) 8–12 weeks postpartum. Prespecified, powered, subgroup comparison was among women with 2 or more social risks. Secondary outcomes included maternal and neonatal birth outcomes; maternal self-efficacy, and mother-to-infant bonding at 8–12 weeks; child development assessment at 6 weeks, breastfeeding at 6 weeks, and immunisation uptake at 4 months, all collected from routine child health systems. Results Antenatal attendances were high in the standard care control and did not increase further with addition of the POW intervention (10.1 vs 10.1 (mean difference; MD) −0.00, 95% CI (95% CI −0.37 to 0.37)). In the powered subgroup of women with 2 or more social risk factors, mean EPDS (MD −0.79 (95% CI −1.56 to −0.02) was significantly better, although for all women recruited, no significant differences were seen (MD −0.59 (95% CI −1.24 to 0.06). Mother-to-infant bonding was significantly better in the intervention group

Maternity care professionals' perceptions of supporting employed women in Norway.

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Alstveit, Marit; Severinsson, Elisabeth; Karlsen, Bjørg

2011-09-01

The World Health Organization calls on health professionals to support women in combining maternity and work. The aim of this study was to explore midwives' and public health nurses' perceptions of supporting employed women to balance work and family life during pregnancy and early motherhood. An exploratory design, including multistage focus group interviews, was used. The focus group consisted of five midwives and one public health nurse who was working in maternity care. The data were analyzed by using qualitative content analysis. The comprehensive theme, "empowering the women when they are in 'another' state of normality", was based on two themes, "being in dialogue with the women" and "supporting the women to manage daily activities". The first theme was based on the subthemes, "perceiving the women to be in 'another' state of normality" and "providing an open atmosphere for dialogue", while the second subtheme was based on "confirming self-esteem" and "suggesting adjustments at work". The midwives and public health nurse empowered the women by enhancing their ability to carry out the self-care that was necessary in order to manage both their work and family life. Collaboration between maternity healthcare providers and employers should be developed in order to support employed women. © 2011 Blackwell Publishing Asia Pty Ltd.

Supporting Employers in the Reserve Operational Forces Era: Are Changes Needed to Reservists’ Employment Rights Legislation, Policies, or Programs?

Science.gov (United States)

2013-01-01

Universal Numbering System EN Employer Notification EP Employer Partnership of the Armed Services EPF Employment Policy Foundation ESGR Employer Support of...on Employers 33 lished in 2005 by the Employment Policy Foundation ( EPF ). According to that report, about half of FMLA leave-takers do not give...Magazine (Bates, 2005), summarizes the findings of a report published in 2005 by EPF ; the original report could not be located because EPF has closed. 4

Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial.

Science.gov (United States)

Brown, Sarah; Smith, Isabelle L; Brown, Julia M; Hulme, Claire; McGinnis, Elizabeth; Stubbs, Nikki; Nelson, E Andrea; Muir, Delia; Rutherford, Claudia; Walker, Kay; Henderson, Valerie; Wilson, Lyn; Gilberts, Rachael; Collier, Howard; Fernandez, Catherine; Hartley, Suzanne; Bhogal, Moninder; Coleman, Susanne; Nixon, Jane E

2016-12-20

Pressure ulcers represent a major burden to patients, carers and the healthcare system, affecting approximately 1 in 17 hospital and 1 in 20 community patients. They impact greatly on an individual's functional status and health-related quality of life. The mainstay of pressure ulcer prevention practice is the provision of pressure redistribution support surfaces and patient repositioning. The aim of the PRESSURE 2 study is to compare the two main mattress types utilised within the NHS: high-specification foam and alternating pressure mattresses, in the prevention of pressure ulcers. PRESSURE 2 is a multicentre, open-label, randomised, double triangular, group sequential, parallel group trial. A maximum of 2954 'high-risk' patients with evidence of acute illness will be randomised on a 1:1 basis to receive either a high-specification foam mattress or alternating-pressure mattress in conjunction with an electric profiling bed frame. The primary objective of the trial is to compare mattresses in terms of the time to developing a new Category 2 or above pressure ulcer by 30 days post end of treatment phase. Secondary endpoints include time to developing new Category 1 and 3 or above pressure ulcers, time to healing of pre-existing Category 2 pressure ulcers, health-related quality of life, cost-effectiveness, incidence of mattress change and safety. Validation objectives are to determine the responsiveness of the Pressure Ulcer Quality of Life-Prevention instrument and the feasibility of having a blinded endpoint assessment using photography. The trial will have a maximum of three planned analyses with unequally spaced reviews at event-driven coherent cut-points. The futility boundaries are constructed as non-binding to allow a decision for stopping early to be overruled by the Data Monitoring and Ethics Committee. The double triangular, group sequential design of the PRESSURE 2 trial will provide an efficient design through the possibility of early stopping for

People into Employment: supporting people with disabilities and carers into work.

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Arksey, Hilary

2003-05-01

Carers and people with disabilities are two disadvantaged groups at risk of social exclusion. Work is an important route to social inclusion, but carers and people with disabilities are under-represented in the work force. The present paper reports key findings from a new study that evaluated People into Employment (PIE), a pilot employment project in the north-east of England designed to support people with disabilities, carers and former carers in gaining mainstream work. The study aimed to identify what clients, partner agencies and employers perceived to be PIE's most important services, its strengths and areas where there was scope for further development. The study collected quantitative and qualitative data at the mid-point and at the end of the project through two questionnaire surveys, and interviews with PIE clients, the project development officer, partner agencies and employers. Drawing on the 'pathway model', the findings show that PIE's interventions included mobilising, matching, mediating and supporting activities. Key ingredients in PIE's success include: tailor-made job-search activities and training; adjusting the pace at which people move towards sustained employment; recognising and responding to the differing needs of people with disabilities, carers and former carers; confidence boosting; accompanying clients to job interviews; good job matching; and ongoing practical and emotional support for both clients and employers. Rudimentary calculations suggest that the cost per job to the project is less than the cost per job for large national projects. Overall, these findings illustrate how access to employment via flexible job-search services geared up to the local labour market can successfully promote social inclusion for carers and people with disabilities.

Study protocol for the 'HelpMeDoIt!' randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity.

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Matthews, Lynsay; Pugmire, Juliana; Moore, Laurence; Kelson, Mark; McConnachie, Alex; McIntosh, Emma; Morgan-Trimmer, Sarah; Murphy, Simon; Hughes, Kathryn; Coulman, Elinor; Utkina-Macaskill, Olga; Simpson, Sharon Anne

2017-10-25

HelpMeDoIt! will test the feasibility of an innovative weight loss intervention using a smartphone app and website. Goal setting, self-monitoring and social support are three key facilitators of behaviour change. HelpMeDoIt! incorporates these features and encourages participants to invite 'helpers' from their social circle to help them achieve their goal(s). To test the feasibility of the intervention in supporting adults with obesity to achieve weight loss goals. 12-month feasibility randomised controlled trial and accompanying process evaluation. Participants (n=120) will be adults interested in losing weight, body mass index (BMI) > 30 kg/m 2 and smartphone users. The intervention group will use the app/website for 12 months. Participants will nominate one or more helpers to support them. Helpers have access to the app/website. The control group will receive a leaflet on healthy lifestyle and will have access to HelpMeDoIt! after follow-up. The key outcome of the study is whether prespecified progression criteria have been met in order to progress to a larger randomised controlled effectiveness trial. Data will be collected at baseline, 6 and 12 months. Outcomes focus on exploring the feasibility of delivering the intervention and include: (i) assessing three primary outcomes (BMI, physical activity and diet); (ii) secondary outcomes of waist/hip circumference, health-related quality of life, social support, self-efficacy, motivation and mental health; (iii) recruitment and retention; (iv) National Health Service (NHS) resource use and participant borne costs; (v) usability and acceptability of the app/website; and (vi) qualitative interviews with up to 50 participants and 20 helpers on their experiences of the intervention. Statistical analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of qualitative interviews will assess implementation, acceptability, mechanisms of effect and contextual

Teaching school children basic life support improves teaching and basic life support skills of medical students: A randomised, controlled trial.

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Beck, Stefanie; Meier-Klages, Vivian; Michaelis, Maria; Sehner, Susanne; Harendza, Sigrid; Zöllner, Christian; Kubitz, Jens Christian

2016-11-01

The "kids save lives" joint-statement highlights the effectiveness of training all school children worldwide in cardiopulmonary resuscitation (CPR) to improve survival after cardiac arrest. The personnel requirement to implement this statement is high. Until now, no randomised controlled trial investigated if medical students benefit from their engagement in the BLS-education of school children regarding their later roles as physicians. The objective of the present study is to evaluate if medical students improve their teaching behaviour and CPR-skills by teaching school children in basic life support. The study is a randomised, single blind, controlled trial carried out with medical students during their final year. In total, 80 participants were allocated alternately to either the intervention or the control group. The intervention group participated in a CPR-instructor-course consisting of a 4h-preparatory seminar and a teaching-session in BLS for school children. The primary endpoints were effectiveness of teaching in an objective teaching examination and pass-rates in a simulated BLS-scenario. The 28 students who completed the CPR-instructor-course had significantly higher scores for effective teaching in five of eight dimensions and passed the BLS-assessment significantly more often than the 25 students of the control group (Odds Ratio (OR): 10.0; 95%-CI: 1.9-54.0; p=0.007). Active teaching of BLS improves teaching behaviour and resuscitation skills of students. Teaching school children in BLS may prepare medical students for their future role as a clinical teacher and support the implementation of the "kids save lives" statement on training all school children worldwide in BLS at the same time. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Cluster randomised controlled trial of a multicomponent intervention to support the implementation of policies and practices that promote healthier environments at junior sports clubs: study protocol

Science.gov (United States)

Milner, Sharin; Sherker, Shauna; Clinton-McHarg, Tara; Dray, Julia; Zukowski, Nadya; Gonzalez, Sharleen; Kingsland, Melanie; Ooi, Jia Ying; Murphy, Allan; Brooke, Daisy; Wiggers, John

2018-01-01

Introduction A large proportion of children and adolescents participate in organised sport, making community sports clubs a promising setting to support healthy behaviours. To date, however, there have been few interventions conducted in junior sports clubs that have targeted health-promoting practices. The primary aim of this pilot study is to assess the potential effectiveness of an intervention to implement health-promoting policies and practices in junior sporting clubs targeting alcohol and tobacco practices, healthy food and beverage availability, and physical activity via participation in sport. A secondary outcome is to assess the impact of such strategies on child exposure to alcohol and tobacco use at the club, purchasing behaviours by/for children at the club canteen and child sports participation opportunities. Methods and analysis The study will employ a cluster randomised controlled trial design and be conducted in metropolitan and regional areas of two Australian states. Randomisation will occur at the level of the football league. Community football clubs with over 40 junior players (players under 18 years) within each league will be eligible to participate. The intervention will be developed based on frameworks that consider the social, cultural and environmental factors that influence health behaviours. Intervention clubs will be supported to implement 16 practices targeting alcohol management, tobacco use, nutrition practices, new player recruitment activity, equal participation for players and the development of policies to support these practices. Trained research staff will collect outcome data via telephone interviews at baseline and follow-up. Interviews will be conducted with both club representatives and parents of junior players. Ethics and dissemination The study has been approved by the University of Newcastle Human Research Ethics Committee (H-2013-0429). The results of the study will be disseminated via peer-reviewed publications and

Text message-based diabetes self-management support (SMS4BG): study protocol for a randomised controlled trial.

Science.gov (United States)

Dobson, Rosie; Whittaker, Robyn; Jiang, Yannan; Shepherd, Matthew; Maddison, Ralph; Carter, Karen; Cutfield, Richard; McNamara, Catherine; Khanolkar, Manish; Murphy, Rinki

2016-04-02

Addressing the increasing prevalence, and associated disease burden, of diabetes is a priority of health services internationally. Interventions to support patients to effectively self-manage their condition have the potential to reduce the risk of costly and debilitating complications. The utilisation of mobile phones to deliver self-management support allows for patient-centred care at the frequency and intensity that patients desire from outside the clinic environment. Self-Management Support for Blood Glucose (SMS4BG) is a novel text message-based intervention for supporting people with diabetes to improve self-management behaviours and achieve better glycaemic control and is tailored to individual patient preferences, demographics, clinical characteristics, and culture. This study aims to assess whether SMS4BG can improve glycaemic control in adults with poorly controlled diabetes. This paper outlines the rationale and methods of the trial. A two-arm, parallel, randomised controlled trial will be conducted across New Zealand health districts. One thousand participants will be randomised at a 1:1 ratio to receive SMS4BG, a theoretically based and individually tailored automated text message-based diabetes self-management support programme (intervention) in addition to usual care, or usual care alone (control). The primary outcome is change in glycaemic control (HbA1c) at 9 months. Secondary outcomes include glycaemic control at 3 and 6 months, self-efficacy, self-care behaviours, diabetes distress, health-related quality of life, perceived social support, and illness perceptions. Cost information and healthcare utilisation will also be collected as well as intervention satisfaction and interaction. This study will provide information on the effectiveness of a text message-based self-management support tool for people with diabetes. If found to be effective it has the potential to provide individualised support to people with diabetes across New Zealand (and

Child Care Is Good Business: A Manual on Employer Supported Child Care.

Science.gov (United States)

Haas, Karen S.

Many companies today consider employer-sponsored child care a viable solution to problems facing employees who are also parents. Companies can choose from many program options, each with particular benefits for employer and employees. This manual highlights what is presently happening in employer-supported child care, particularly the cost…

Flexible employment and nurses' intention to leave the profession: The role of support at work.

Science.gov (United States)

Zeytinoglu, Isik U; Denton, Margaret; Plenderleith, Jennifer Millen

2011-02-01

The objectives of this paper are to examine (1) the association between flexible employment and nurses' intention to leave the profession, and (2) whether or not support at work mediates the association between flexible employment and nurses' intention to leave the profession. Flexible employment is analyzed objectively using non-permanent contract, part-time employment status, casual employment status, involuntary hours and on-call work, and subjectively using job insecurity. Support at work refers to organizational, supervisor and peer support. Data come from our survey of 1396 nurses employed in three teaching hospitals in Southern Ontario. Descriptive statistics are provided. Bivariate correlations, hierarchical regression analysis and mediation tests are conducted. Compared to those in full-time employment, nurses in part-time employment do not intend to leave the profession. None of the other objective flexible employment factors are associated with intention to leave the profession. Perceived job insecurity is associated with intention to leave the profession. Low support at work contributes to intention to leave the profession and mediates the association between job insecurity and intention to leave the profession. The study provides evidence to health sector managers and policy makers that part-time employment, perceived job security and support at work are important factors to consider in efforts to retain nurses in the profession. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Collaboration between Supported Employment and Human Resource Services: Strategies for Success

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Post, Michal; Campbell, Camille; Heinz, Tom; Kotsonas, Lori; Montgomery, Joyce; Storey, Keith

2010-01-01

The article presents the benefits of successful collaboration between supported employment agencies and human resource managers when working together to secure employment for individuals with disabilities. Two case studies are presented: one involving a successful collaboration with county human resource managers in negotiating a change in the…

Protocol for SAMS (Support and Advice for Medication Study: A randomised controlled trial of an intervention to support patients with type 2 diabetes with adherence to medication

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Sutton Stephen

2008-04-01

Full Text Available Abstract Background Although some interventions have been shown to improve adherence to medication for diabetes, results are not consistent. We have developed a theory-based intervention which we will evaluate in a well characterised population to test efficacy and guide future intervention development and trial design. Methods and Design The SAMS (Supported Adherence to Medication Study trial is a primary care based multi-centre randomised controlled trial among 200 patients with type 2 diabetes and an HbA1c of 7.5% or above. It is designed to evaluate the efficacy of a two-component motivational intervention based on the Theory of Planned Behaviour and volitional action planning to support medication adherence compared with standard care. The intervention is delivered by practice nurses. Nurses were trained using a workshop approach with role play and supervised using assessment of tape-recorded consultations. The trial has a two parallel groups design with an unbalanced three-to-two individual randomisation eight weeks after recruitment with twelve week follow-up. The primary outcome is medication adherence measured using an electronic medication monitor over 12 weeks and expressed as the difference between intervention and control in mean percentage of days on which the correct number of medication doses is taken. Subgroup analyses will explore impact of number of medications taken, age, HbA1c, and self-reported adherence at baseline on outcomes. The study also measures the effect of dispensing medication to trial participants packaged in the electronic medication-monitoring device compared with conventional medication packaging. This will be achieved through one-to-one randomisation at recruitment to these conditions with assessment of the difference between groups in self-report of medication adherence and change in mean HbA1c from baseline to eight weeks. Anonymised demographic data are collected on non-respondents. Central randomisation

Supported Employment for Young Adults with Autism Spectrum Disorder: Preliminary Data

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Wehman, Paul; Lau, Stephanie; Molinelli, Alissa; Brooke, Valerie; Thompson, Katie; Moore, Chandler; West, Michael

2012-01-01

The purpose of this study was to examine the effects of supported employment in securing and maintaining competitive employment for people with autism spectrum disorder, a group that has typically been found to be underemployed or unemployed. This prospective study followed and collected data on 33 individuals with autism spectrum disorder as they…

Health and social support services to HIV/AIDS infected individuals in Tanzania: employees and employers perceptions.

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Kassile, Telemu; Anicetus, Honest; Kukula, Raphael; Mmbando, Bruno P

2014-06-20

HIV is a major public health problem in the world, especially in sub-Saharan Africa. It often leads to loss of productive labour and disruption of existing social support system which results in deterioration of population health. This poses a great challenge to infected people in meeting their essential goods and services. This paper examines health and social support services provided by employers to HIV/AIDS infected employees in Tanzania. This was a cross-sectional study, which employed qualitative and quantitative methods in data collection and analysis. Structured questionnaires and in-depth interviews were used to assess the health and social support services provision at employers and employees perspectives. The study participants were employees and employers from public and private organizations. A total of 181 employees and 23 employers from 23 workplaces aged between 18-68 years were involved. The results show that 23.8% (i.e., 20.4% males and 27.3% females) of the employees had at least one member of the family or close relatives living with HIV at the time of the study. Fifty six percent of the infected employees reported to have been receiving health or social support from their employers. Employees' responses were consistent with those reported by their employers. A total of 12(52.2%) and 11(47.8%) employers reported to have been providing health and social supports respectively. Female employees (58.3%) from the private sector (60.0%) were more likely to receive supports than male employees (52.6%) and than those from the public sector (46.2%). The most common health and social support received by the employees were treatment, and nutritional support and reduction of workload, respectively. HIV/AIDS infected employees named treatment and nutritional support, and soft loans and reduced workload respectively, as the most important health and social supports they needed from their employers. This study provides baseline information for further studies

Transitioning to employment with a rheumatic disease: the role of independence, overprotection, and social support.

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Jetha, Arif; Badley, Elizabeth; Beaton, Dorcas; Fortin, Paul R; Shiff, Natalie J; Rosenberg, Alan M; Tucker, Lori B; Mosher, Dianne P; Gignac, Monique A M

2014-12-01

To examine perceived independence, overprotection, and support, and their association with the employment participation of young adults with rheumatic disease. One hundred and forty-three young adults, ages 18 to 30 years, with systemic lupus erythematosus (54.5%) and juvenile arthritis (45.5%) completed a 30-min online questionnaire of their work and education experiences. Information collected was demographic, health (e.g., pain, fatigue, disease activity), work context (e.g., career satisfaction, helpfulness of job accommodation/benefits, and workplace activity limitations), and psychosocial (e.g., independence, social support, and overprotection). Log-Poisson regression analysis examined factors associated with employment status. Over half of respondents were employed (59%) and 26% were enrolled in school. Respondents reported moderate to high perceptions of independence and social support. However, 27% reported that "quite a bit" to "a great deal" of overprotection characterized their relationships with those closest to them. At the bivariate level, employed participants and those indicating greater perceived independence reported greater social support and less overprotection. Multivariable analysis revealed that being employed was associated with older age, more job accommodations/benefits perceived as being helpful, and greater perceived independence. This is one of the first studies examining the employment of young adults with rheumatic diseases. Findings highlight the importance of psychosocial perceptions such as independence and overprotection, in addition to support related to working. Additional research is needed to better understand the role of those close to young adults with rheumatic diseases in supporting independence and encouraging employment.

Smartphone-Supported versus Full Behavioural Activation for Depression: A Randomised Controlled Trial.

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Kien Hoa Ly

Full Text Available There is need for more cost and time effective treatments for depression. This is the first randomised controlled trial in which a blended treatment--including four face-to-face sessions and a smartphone application--was compared against a full behavioural treatment. Hence, the aim of the current paper was to examine whether a blended smartphone treatment was non-inferior to a full behavioural activation treatment for depression.This was a randomised controlled non-inferiority trial (NCT01819025 comparing a blended treatment (n=46 against a full ten-session treatment (n=47 for people suffering from major depression. Primary outcome measure was the BDI-II, that was administered at pre- and post-treatment, as well as six months after the treatment.Results showed significant improvements in both groups across time on the primary outcome measure (within-group Cohen's d=1.35; CI [-0.82, 3.52] to d=1.47; CI [-0.41, 3.35]; between group d=-0.13 CI [-2.37, 2.09] and d=-0.10 CI [-2.53, 2.33]. At the same time, the blended treatment reduced the therapist time with an average of 47%.We could not establish whether the blended treatment was non-inferior to a full BA treatment. Nevertheless, this study points to that the blended treatment approach could possibly treat nearly twice as many patients suffering from depression by using a smartphone application as add-on. More studies are needed before we can suggest that the blended treatment method is a promising cost-effective alternative to regular face-to-face treatment for depression.Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support NCT01819025.

Social Support, Unfulfilled Expectations, and Affective Well-Being on Return to Employment

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Seiger, Christine P.; Wiese, Bettina S.

2011-01-01

We conducted a longitudinal study to investigate how social support from the partner is related to mothers' affective well-being during their return to employment after maternity leave and whether expectations of that support have an additional impact. We differentiated four forms of support and their respective expectation discrepancies:…

Quit in General Practice: a cluster randomised trial of enhanced in-practice support for smoking cessation

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Zwar Nicholas

2010-08-01

Full Text Available Abstract Background This study will test the uptake and effectiveness of a flexible package of smoking cessation support provided primarily by the practice nurse (PN and tailored to meet the needs of a diversity of patients. Methods/Design This study is a cluster randomised trial, with practices allocated to one of three groups 1 Quit with Practice Nurse 2 Quitline referral 3 GP usual care. PNs from practices randomised to the intervention group will receive a training course in smoking cessation followed by access to mentoring. GPs from practices randomised to the Quitline referral group will receive information about the study and the process of written referral and GPs in the usual care group will receive information about the study. Eligible patients are those aged 18 and over presenting to their GP who are daily or weekly smokers and who are able to give informed consent. Patients on low incomes in all three groups will be able to access free nicotine patches. Primary outcomes are sustained abstinence and point prevalence abstinence at the three month and 12 month follow-up points; and incremental cost effectiveness ratios at 12 months. Process evaluation on the reach and acceptability of the intervention approached will be collected through Computer Assisted Telephone Interviews (CATI with patients and semi-structured interviews with PNs and GPs. The primary analysis will be by intention to treat. Cessation outcomes will be compared between the three arms at three months and 12 month follow-up using multiple logistic regression. The incremental cost effectiveness ratios will be estimated for the 12 month quit rate for the intervention groups compared to usual care and to each other. Analysis of qualitative data on process outcomes will be based on thematic analysis. Discussion High quality evidence on effectiveness of practice nurse interventions is needed to inform health policy on development of practice nurse roles. If effective

Employers Roundtable: Employer Supported Child Care.

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Delaware Valley Child Care Council, Philadelphia, PA.

This booklet outlines a number of options available to employers to enable them to better cope with child care issues that they and their employees face. Major options include: (1) flexible work policies, such as flexible scheduling, alternate work places, shorter work weeks, and the consolidating of sick leave, holidays, and vacation time into…

The Cost-Effectiveness of Supported Employment for Adults with Autism in the United Kingdom

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Mavranezouli, Ifigeneia; Megnin-Viggars, Odette; Cheema, Nadir; Howlin, Patricia; Baron-Cohen, Simon; Pilling, Stephen

2014-01-01

Adults with autism face high rates of unemployment. Supported employment enables individuals with autism to secure and maintain a paid job in a regular work environment. The objective of this study was to assess the cost-effectiveness of supported employment compared with standard care (day services) for adults with autism in the United Kingdom.…

The Role of Higher Education Skills and Support in Graduate Self-Employment

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Greene, Francis J.; Saridakis, George

2008-01-01

This article examines the career progression of self-employed graduates immediately following graduation and four years subsequently. Using a career socialization theory specific to entrepreneurial settings, it links the role of skills acquired in UK higher education courses and the use of support with self-employment outcomes. Using a wide range…

Employment Status and Mental Health: Mediating Roles of Social Support and Coping Strategies.

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Perreault, Michel; Touré, El Hadj; Perreault, Nicole; Caron, Jean

2017-09-01

Although it has been established that unemployment and underemployment increase distress and depression, the psychological mechanisms involved are not very clear. This study examines the roles of social support and coping strategies as mediators of the association between employment status and mental health, as well as gender and age differences as moderators. Residents from the epidemiological catchment area of south-west Montreal responded to a randomized household survey for adults in 2009. A follow-up was conducted based on participants' employment status 2 and 4 years later. ANOVAs tests were computed with SPSS to evaluate group differences, and structural equation modeling was performed with AMOS to test mediation effects. At baseline, among participants between 18 and 64 years old (n = 2325), 14.3 % were unemployed/not studying, 14.4 % worked part-time, and 56.5 % worked full-time. Employment status was found to significantly affect depression among those under 45 years old (chi-square = 23.4, p employment with depression, which was fully mediated by social support, less coping with drugs/medication, and less distress. A negative association with full-time employment was also noted with distress, which was partially mediated by increased social support, coping with alcohol, and less coping with drugs/medication. The total indirect effect suggests that full-time employees generally have more resources and do not tend to use avoidance strategies like coping with drugs/medication, resulting in less distress (β = -0.05; p employment, namely full-time employment, in communities.

A hybrid supported employment program for persons with schizophrenia in Japan.

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Fuller, T R; Oka, M; Otsuka, K; Yokoyama, N; Liberman, R P; Niwa, S I

2000-07-01

INTRODUCTION BY THE COLUMN EDITORS: Because the mental health system in Japan has emphasized hospital-based treatment (1), patients with schizophrenia often remain institutionalized for long periods, even after their symptoms have stabilized. In addition, the introduction of modern community-based methods of treatment and rehabilitation was delayed by an antipsychiatry movement in the 1970s and the ascendance of a reductionistic biological approach to services (2). Lack of adequate outpatient services and community residential care in Japan has been a serious obstacle to destigmatization of mental disorders and has contributed to the heavy burden and stress experienced by families of mentally ill persons (3). More than 80 percent of patients discharged from mental hospitals return to live with their families, who are ill prepared to provide the supportive services required for community tenure. Involvement in work activities can facilitate community reentry for people with serious and persistent mental illness because employment displaces symptoms, provides structure and meaning in daily life, offers socialization with peers, and permits workers to earn income for shelter and food. In this issue's Rehab Rounds column, the authors describe an innovative vocational rehabilitation program for patients with schizophrenia that was designed to overcome obstacles to discharge and community adjustment. The program at Yabuki Prefecture Psychiatric Hospital, in the northern prefecture of Fukushima, Japan, has been successful in training patients for competitive work while capitalizing on the importance of work in Japanese culture and its traditionally supportive employer-employee relationships. The program is termed "hybrid" because it combines elements of transitional employment with supported employment (4).

In-vivo job development training among peer providers of homeless veterans supported employment programs.

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Gao, Ni; Dolce, Joni; Rio, John; Heitzmann, Carma; Loving, Samantha

2016-06-01

This column describes a goal-oriented, time-limited in vivo coaching/training approach for skills building among peer veterans vocational rehabilitation specialists of the Homeless Veteran Supported Employment Program (HVSEP). Planning, implementing, and evaluating the training approach for peer providers was intended, ultimately, to support veterans in their goal of returning to community competitive employment. The description draws from the training experience that aimed to improve the ability of peer providers to increase both rates of employment and wages of the homeless veterans using their services. Training peers using an in vivo training approach provided a unique opportunity for the veterans to improve their job development skills with a focus to support employment outcomes for the service users. Peers who received training also expressed that learning skills through an in vivo training approach was more engaging than typical classroom trainings. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

A feasibility study for a randomised controlled trial of the Positive Reappraisal Coping Intervention, a novel supportive technique for recurrent miscarriage.

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Bailey, Sarah; Bailey, Chris; Boivin, Jacky; Cheong, Ying; Reading, Isabel; Macklon, Nick

2015-04-15

Recurrent miscarriage (RM) is diagnosed when a woman has had three or more miscarriages. Increased levels of distress and anxiety are common during the waiting period of any subsequent pregnancies, posing a significant threat to psychological well-being. However, only limited support and therapy are available for these women, and many are left to cope alone. The Positive Reappraisal Coping Intervention (PRCI) is a novel self-administered supportive technique which has been shown to be effective in patients awaiting the outcome of in vitro fertilisation treatment. The primary objective of this study is to assess the feasibility and effectiveness of the PRCI in improving quality of life in the difficult waiting period which women with previous RM endure before an ongoing pregnancy can be confirmed. A randomised controlled trial (RCT) feasibility study will establish the viability of conducting a multicentre RCT to definitively test the effects of the PRCI on the psychological well-being of women who have experienced RM during the initial waiting period of a subsequent pregnancy. A second component consists of a qualitative process evaluation exploring the initial experience of pregnancy following repeated miscarriages. Participants (n=50) will be randomised into one of two groups. The PRCI intervention group will receive the PRCI card and weekly questionnaires to assess their psychological well-being during the waiting period of their new pregnancy. The non-intervention group will be asked to complete the same weekly questionnaires. The qualitative process analysis will employ semistructured interviews (n=20) to address relevant aspects of the study objectives. Ethics approval has been obtained from the National Research Ethics Service Committee South Central-Hampshire A. Participating centres have given National Health Service R&D approval. Study findings will be disseminated through peer reviewed journals, national and international conferences and lay user groups

‘Placement budgets’ for supported employment – improving competitive employment for people with mental illness: study protocol of a multicentre randomized controlled trial

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Nordt Carlos

2012-10-01

Full Text Available Abstract Background Vocational integration of people with mental illness is poor despite their willingness to work. The ‘Individual Placement and Support’ (IPS model which emphasises rapid and direct job placement and continuing support to patient and employer has proven to be the most effective vocational intervention programme. Various studies have shown that every second patient with severe mental illness was able to find competitive employment within 18 months. However, the goal of taking up employment within two months was rarely achieved. Thus, we aim to test whether the new concept of limited placement budgets increases the effectiveness of IPS. Methods/Design Six job coaches in six out-patients psychiatric clinics in the Canton of Zurich support unemployed patients of their clinic who seek competitive employment. Between June 2010 and May 2011 patients (N=100 are randomly assigned to three different placement budgets of 25h, 40h, or 55h working hours of job coaches. Support lasts two years for those who find a job. The intervention ends for those who fail to find competitive employment when the respective placement budgets run out. The primary outcome measure is the time between study inclusion and first competitive employment that lasted three months or longer. Over a period of three years interviews are carried out every six months to measure changes in motivation, stigmatization, social network and social support, quality of life, job satisfaction, financial situation, and health conditions. Cognitive and social-cognitive tests are conducted at baseline to control for confounding variables. Discussion This study will show whether the effectiveness of IPS can be increased by the new concept of limited placement budgets. It will also be examined whether competitive employment leads in the long term to an improvement of mental illness, to a transfer of the psychiatric support system to private and vocational networks, to an increase

Employment Interventions for Individuals with ASD: The Relative Efficacy of Supported Employment With or Without Prior Project SEARCH Training.

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Schall, Carol M; Wehman, Paul; Brooke, Valerie; Graham, Carolyn; McDonough, Jennifer; Brooke, Alissa; Ham, Whitney; Rounds, Rachael; Lau, Stephanie; Allen, Jaclyn

2015-12-01

This paper presents findings from a retrospective observational records review study that compares the outcomes associated with implementation of supported employment (SE) with and without prior Project SEARCH with ASD Supports (PS-ASD) on wages earned, time spent in intervention, and job retention. Results suggest that SE resulted in competitive employment for 45 adults with ASD. Twenty-five individuals received prior intervention through PS-ASD while the other 20 individuals received SE only. Individuals in this sample who received PS-ASD required fewer hours of intervention. Additionally, individuals in the PS-ASD group achieved a mean higher wage and had higher retention rates than their peers who received SE only. Further research with a larger sample is needed to confirm these findings.

Mechanical supports for acute, severe ankle sprain: a pragmatic, multicentre, randomised controlled trial.

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Lamb, S E; Marsh, J L; Hutton, J L; Nakash, R; Cooke, M W

2009-02-14

Severe ankle sprains are a common presentation in emergency departments in the UK. We aimed to assess the effectiveness of three different mechanical supports (Aircast brace, Bledsoe boot, or 10-day below-knee cast) compared with that of a double-layer tubular compression bandage in promoting recovery after severe ankle sprains. We did a pragmatic, multicentre randomised trial with blinded assessment of outcome. 584 participants with severe ankle sprain were recruited between April, 2003, and July, 2005, from eight emergency departments across the UK. Participants were provided with a mechanical support within the first 3 days of attendance by a trained health-care professional, and given advice on reducing swelling and pain. Functional outcomes were measured over 9 months. The primary outcome was quality of ankle function at 3 months, measured using the Foot and Ankle Score; analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN37807450. Patients who received the below-knee cast had a more rapid recovery than those given the tubular compression bandage. We noted clinically important benefits at 3 months in quality of ankle function with the cast compared with tubular compression bandage (mean difference 9%; 95% CI 2.4-15.0), as well as in pain, symptoms, and activity. The mean difference in quality of ankle function between Aircast brace and tubular compression bandage was 8%; 95% CI 1.8-14.2, but there were little differences for pain, symptoms, and activity. Bledsoe boots offered no benefit over tubular compression bandage, which was the least effective treatment throughout the recovery period. There were no significant differences between tubular compression bandage and the other treatments at 9 months. Side-effects were rare with no discernible differences between treatments. Reported events (all treatments combined) were cellulitis (two cases), pulmonary embolus (two cases), and

Return to work in sick-listed cancer survivors with job loss: design of a randomised controlled trial.

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van Egmond, Martine P; Duijts, Saskia F A; Vermeulen, Sylvia J; van der Beek, Allard J; Anema, Johannes R

2015-02-18

Despite long-term or permanent health problems, cancer survivors are often motivated to return to work. For cancer survivors who have lost their job, return to work can be more challenging compared to employed survivors, as they generally find themselves in a more vulnerable social and financial position. Cancer survivors with job loss may therefore be in need of tailored return to work support. However, there is a lack of return to work intervention programs specifically targeting these cancer survivors. The number of cancer survivors with job loss in developed countries is rising due to, amongst others, increases in the incidence and survivor rate of cancer, the retirement age and the proportion of flexible employment contracts. Hence, we consider it important to develop a tailored return to work intervention program for cancer survivors with job loss, and to evaluate its effectiveness compared to usual care. This study employs a two-armed randomised controlled trial with a follow-up period of 12 months. The study population (n = 164) will be recruited from a national sample of cancer survivors (18-60 years), who have been sick-listed for 12-36 months. Participants will be randomised by using computerized blocked randomisation (blocks of four). All participants will receive usual care as provided by the Dutch Social Security Agency. Additionally, participants in the intervention group will receive a tailored return to work intervention program, which includes vocational rehabilitation and supportive psychosocial components, as well as (therapeutic) placement at work. The primary outcome measure is duration until sustainable return to work; the secondary outcome measure is rate of return to work. Other parameters include, amongst others, fatigue, coping strategy and quality of life. We will perform Cox regression analyses to estimate hazard ratios for time to sustainable return to work. The hypothesis of this study is that a tailored approach for cancer

Individual Placement and Support in Spinal Cord Injury: A Longitudinal Observational Study of Employment Outcomes.

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Ottomanelli, Lisa; Goetz, Lance L; Barnett, Scott D; Njoh, Eni; Dixon, Thomas M; Holmes, Sally Ann; LePage, James P; Ota, Doug; Sabharwal, Sunil; White, Kevin T

2017-08-01

To determine the effects of a 24-month program of Individual Placement and Support (IPS) supported employment (SE) on employment outcomes for veterans with spinal cord injury (SCI). Longitudinal, observational multisite study of a single-arm, nonrandomized cohort. SCI centers in the Veterans Health Administration (n=7). Veterans with SCI (N=213) enrolled during an episode of either inpatient hospital care (24.4%) or outpatient care (75.6%). More than half the sample (59.2%) had a history of traumatic brain injury (TBI). IPS SE for 24 months. Competitive employment. Over the 24-month period, 92 of 213 IPS participants obtained competitive jobs for an overall employment rate of 43.2%. For the subsample of participants without TBI enrolled as outpatients (n=69), 36 obtained competitive jobs for an overall employment rate of 52.2%. Overall, employed participants averaged 38.2±29.7 weeks of employment, with an average time to first employment of 348.3±220.0 days. Nearly 25% of first jobs occurred within 4 to 6 months of beginning the program. Similar employment characteristics were observed in the subsample without TBI history enrolled as outpatients. Almost half of the veterans with SCI participating in the 24-month IPS program as part of their ongoing SCI care achieved competitive employment, consistent with their expressed preferences at the start of the study. Among a subsample of veterans without TBI history enrolled as outpatients, employment rates were >50%. Time to first employment was highly variable, but quite long in many instances. These findings support offering continued IPS services as part of ongoing SCI care to achieve positive employment outcomes. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Evaluation of Lay Support in Pregnant women with Social risk (ELSIPS: a randomised controlled trial

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Kenyon Sara

2012-02-01

Full Text Available Abstract Background Maternal, neonatal and child health outcomes are worse in families from black and ethnic minority groups and disadvantaged backgrounds. There is little evidence on whether lay support improves maternal and infant outcomes among women with complex social needs within a disadvantaged multi-ethnic population in the United Kingdom (UK. Method/Design The aim of this study is to evaluate a lay Pregnancy Outreach Worker (POW service for nulliparous women identified as having social risk within a maternity service that is systematically assessing social risks alongside the usual obstetric and medical risks. The study design is a randomised controlled trial (RCT in nulliparous women assessed as having social risk comparing standard maternity care with the addition of referral to the POW support service. The POWs work alongside community midwifery teams and offer individualised support to women to encourage engagement with services (health and social care from randomisation (before 28 weeks gestation until 6 weeks after birth. The primary outcomes have been chosen on the basis that they are linked to maternal and infant health. The two primary outcomes are engagement with antenatal care, assessed by the number of antenatal visits; and maternal depression, assessed using the Edinburgh Postnatal Depression Scale at 8-12 weeks after birth. Secondary outcomes include maternal and neonatal morbidity and mortality, routine child health assessments, including immunisation uptake and breastfeeding at 6 weeks. Other psychological outcomes (self efficacy and mother-to-infant bonding will also be collected using validated tools. A sample size of 1316 will provide 90% power (at the 5% significance level to detect increased engagement with antenatal services of 1.5 visits and a reduction of 1.5 in the average EPDS score for women with two or more social risk factors, with power in excess of this for women with any social risk factor. Analysis will

Well-being improvement in a midsize employer: changes in well-being, productivity, health risk, and perceived employer support after implementation of a well-being improvement strategy.

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Hamar, Brent; Coberley, Carter; Pope, James E; Rula, Elizabeth Y

2015-04-01

To evaluate employee well-being change and associated change in productivity, health risk including biometrics, and workplace support over 2 years after implementation of a well-being improvement strategy. This was an employer case study evaluation of well-being, productivity (presenteeism, absenteeism, and job performance), health risk, and employer support across three employee assessment spanning 2 years. Employee well-being was compared with an independent sample of workers in the community. Well-being and job performance increased and presenteeism and health risk decreased significantly over the 2 years. Employee well-being started lower and increased to exceed community worker averages, approaching significance. Well-being improvement was associated with higher productivity across all measures. Increases in employer support for well-being were associated with improved well-being and productivity. This employer's well-being strategy, including a culture supporting well-being, was associated with improved health and productivity.

Developing a workplace breast feeding support model for employed lactating mothers.

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Yimyam, Susanha; Hanpa, Wasana

2014-06-01

Resuming work is often considered an obstacle for continued breast feeding. The objectives of this participatory action research study were to develop a breast feeding support model in the workplace and to compare breast feeding rates before and after implementation of the breast feeding support campaign. Twenty-four women participated before the implementation of the breast feeding support campaign, whereas 31 women participated after the campaign. Data were collected by interviewing employed women about their breast feeding practices within six months post partum. Additional data were collected through interviews with the workplace administrator and head of work sections as well as observation of the breast feeding support campaigns. Qualitative data were analysed using thematic analysis, whereas quantitative data were analysed using descriptive statistics and χ(2) test. The workplace breast feeding support model was developed based on the concept of Mother-Friendly Workplace Initiatives by the World Alliance for Breastfeeding Action (WABA) and the Thai government׳s promotion of a workplace breast feeding corner. Within this model, a committee for breast feeding support was created for working with the research team to develop breast feeding activities and media for breast feeding education and breast feeding support campaigns in the workplace. Breast feeding rates at six months after implementation of the breast feeding support campaign were significantly higher than rates before, both for exclusive breast feeding and any breast feeding at levels .004 and .033, respectively. These results suggest that breast feeding should be encouraged in every workplace depending on context. Individual advice and help for employed mothers should be provided from pregnancy through weaning in the postpartum period. Copyright © 2014 Elsevier Ltd. All rights reserved.

Helping adolescents to better support their peers with a mental health problem: A cluster-randomised crossover trial of teen Mental Health First Aid.

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Hart, Laura M; Morgan, Amy J; Rossetto, Alyssia; Kelly, Claire M; Mackinnon, Andrew; Jorm, Anthony F

2018-02-01

teen Mental Health First Aid (tMHFA) is a classroom-based training programme for students aged 15-18 years to improve supportive behaviours towards peers, increase mental health literacy and reduce stigma. This research evaluated tMHFA by comparing it to a matched emergency Physical First Aid (PFA) training programme. A cluster-randomised crossover trial matched four public schools in two pairs and then randomised each to first receive tMHFA or PFA for all Year 10 students. In the subsequent calendar year, the new Year 10 cohort received the opposite intervention, giving eight cohorts. Online surveys were administered at baseline and 1 week post-training, measuring quality of first aid intentions, mental health literacy, problem recognition and stigmatising beliefs, towards fictional adolescents with depression and suicidality (John) and social anxiety (Jeanie). A total of 1942 students were randomised (979 received tMHFA, 948 received PFA), 1605 (84%) analysed for the John vignette at baseline and 1116 (69% of baseline) provided post-training data. The primary outcomes, 'helpful first aid intentions' towards John/Jeanie, showed significant group-by-time interactions with medium effect sizes favouring tMHFA ( ds = 0.50-0.58). Compared to PFA, tMHFA students also reported significantly greater improvements in confidence supporting a peer ( ds = 0.22-0.37) and number of adults rated as helpful ( ds = 0.45-0.46) and greater reductions in stigmatising beliefs ( ds = 0.12-0.40) and 'harmful first aid intentions' towards John/Jeanie ( ds = 0.15-0.41). tMHFA is an effective and feasible programme for increasing supportive first aid intentions and mental health literacy in adolescents in the short term. tMHFA could be widely disseminated to positively impact on help seeking for adolescent mental illness.

Tailored online cognitive behavioural therapy with or without therapist support calls to target psychological distress in adults receiving haemodialysis: A feasibility randomised controlled trial.

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Hudson, Joanna L; Moss-Morris, Rona; Norton, Sam; Picariello, Federica; Game, David; Carroll, Amy; Spencer, Jonathan; McCrone, Paul; Hotopf, Matthew; Yardley, Lucy; Chilcot, Joseph

2017-11-01

Psychological distress is prevalent in haemodialysis (HD) patients yet access to psychotherapy remains limited. This study assessed the feasibility and acceptability of online cognitive-behavioural therapy (CBT) tailored for HD patients, with or without therapist support, for managing psychological distress. This feasibility randomised controlled trial recruited patients from a UK HD centre. Following psychological distress screens, patients with mild-moderate psychological distress (Patient Health Questionnaire PHQ-9; score: 5-19 and/or Generalised Anxiety Disorder; GAD-7 score: 5-14) who met remaining inclusion criteria were approached for consent. Consenters were individually randomised (1:1) to online-CBT or online-CBT plus three therapist support calls. Outcomes included recruitment, retention, and adherence rates. Exploratory change analyses were performed for: psychological distress, quality of life (QoL), illness perceptions, and costs. The statistician was blinded to allocation. 182 (44%) out of 410 patients approached completed psychological distress screens. 26% found screening unacceptable; a further 30% found it unfeasible. Psychological distress was detected in 101 (55%) patients, 60 of these met remaining inclusion criteria. The primary reason for ineligibility was poor computer literacy (N=17, 53%). Twenty-five patients were randomised to the supported (N=18) or unsupported arm (N=7); 92% were retained at follow-up. No differences in psychological distress or cost-effectiveness were observed. No trial adverse events occurred. Online CBT appears feasible but only for computer literate patients who identify with the label psychological distress. A definitive trial using the current methods for psychological distress screening and online care delivery is unfeasible. ClinicalTrials.gov Identifier: NCT02352870. Copyright © 2017 Elsevier Inc. All rights reserved.

A randomized controlled trial of a supported employment program for persons with long-term mental illness in Hong Kong.

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Kin Wong, Kenny; Chiu, Rose; Tang, Betty; Mak, Donald; Liu, Joanne; Chiu, Siu Ning

2008-01-01

Supported employment is an evidence-based practice that has proved to be consistently more effective than conventional vocational rehabilitation in helping people with severe mental illness find and sustain competitive employment. Most research on the effectiveness of supported employment comes from the United States. This study examined the effectiveness and applicability of a supported employment program based on the individual placement and support model in a Hong Kong setting. Ninety-two unemployed individuals with long-term mental illness who desired competitive employment were randomly assigned to either a supported employment program or a conventional vocational rehabilitation program and followed up for 18 months. Both vocational and nonvocational outcomes were measured. Over the 18-month study period, compared with participants in the conventional vocational rehabilitation program, those in the supported employment group were more likely to work competitively (70% versus 29%; odds ratio=5.63, 95% confidence interval=2.28-13.84), held a greater number of competitive jobs, earned more income, worked more days, and sustained longer job tenures. Repeated-measures analysis of variance found no substantive differences between participants in the two groups and no significant change from baseline over time for psychiatric symptoms and self-perceived quality of life. Consistent with previous research findings in the United States, the supported employment program was more effective than the conventional vocational rehabilitation program in helping individuals with long-term mental illness find and sustain competitive employment in a Hong Kong setting. The supported employment program based on the individual placement and support model can thus be recommended for wider use in local mental health practice.

[Telephone support for breastfeeding by primary care: a randomised multicentre trial].

Science.gov (United States)

Balaguer Martínez, Josep Vicent; Valcarce Pérez, Inmaculada; Esquivel Ojeda, Jessica Noelia; Hernández Gil, Alicia; Martín Jiménez, María Del Pilar; Bernad Albareda, Mercè

2018-03-22

To evaluate a telephone support programme for mothers who breastfeed for the first 6 months. A randomised unmasked clinical trial was conducted in 5 urban Primary Care centres that included mothers with healthy newborns who were breastfeeding exclusively (EBF) or partially (PBF). The control group received the usual care. The intervention group also received telephone support for breastfeeding on a weekly basis for the first 2months and then every 2weeks until the sixth month. The type of breastfeeding was recorded in the usual check-up visit (1, 2, 4 and 6 months). The study included 193 patients in the intervention group, and 187 in a control group. The greatest increase in the percentage of EBF was observed at 6 months: 21.4% in the control group compared to 30.1% in the intervention group. However, in the adjusted odds ratios analysis, confidence intervals did not show statistical significance. The odds ratio at 1 month, 2 months, 4 months, and 6 months for EBF were 1.45 (0.91-2.31), 1.35 (0.87-2.08), 1.21 (0.80-1.81), and 1.58 (0.99-2.53), respectively. The odds ratio in the same age groups for any type of breastfeeding (EBF + PBF) were 1.65 (0.39-7.00), 2.08 (0.94-4.61), 1.37 (0.79-2.38), and 1.60 (0.98-2.61), respectively. Telephone intervention was not effective enough to generalise it. Copyright © 2018. Publicado por Elsevier España, S.L.U.

Vocational rehabilitation services for patients with cancer: design of a feasibility study incorporating a pilot randomised controlled trial among women with breast cancer following surgery

Directory of Open Access Journals (Sweden)

Ayansina Dolapo

2011-03-01

Full Text Available Abstract Background Due to improvements in cancer survival the number of people of working age living with cancer across Europe is likely to increase. UK governments have made commitments to reduce the number of working days lost to ill-health and to improve access to vocational rehabilitation (VR services. Return to work for people with cancer has been identified as a priority. However, there are few services to support people to remain in or return to work after cancer and no associated trials to assess their impact. A pilot randomised controlled trial among women with breast cancer has been designed to assess the feasibility of a larger definitive trial of VR services for people with cancer. Methods Patients are being recruited from three clinical sites in two Scottish National Health Service (NHS Boards for 6 months. Eligible patients are all women who are: (1 aged between 18 and 65 years; (2 in paid employment or self-employed; (3 living or working in Lothian or Tayside, Scotland, UK; (4 diagnosed with an invasive breast cancer tumour; (5 treated first with surgery. Patients are randomly allocated to receive referral to a VR service or usual care, which involves no formal employment support. The primary outcome measure is self-reported sickness absence in the first 6 months following surgery. Secondary outcome measures include changes in quality of life (FACT-B, fatigue (FACIT-Fatigue and employment status between baseline and 6- and 12-months post-surgery. A post-trial evaluation will be conducted to assess the acceptability of the intervention among participants and the feasibility of a larger, more definitive, trial with patients with lung and prostate cancer. Discussion To our knowledge this is the first study to determine the feasibility of a randomised controlled trial of the effectiveness of VR services to enable people with cancer to remain in or return to employment. The study will provide evidence to assess the relevance and

Work-related discrimination and change in self-stigma among people with mental illness during supported employment.

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Rüsch, Nicolas; Nordt, Carlos; Kawohl, Wolfram; Brantschen, Elisabeth; Bärtsch, Bettina; Müller, Mario; Corrigan, Patrick W; Rössler, Wulf

2014-12-01

The relationship of work-related discrimination to the change in self-stigma and stigma stress was assessed among supported employment participants in Switzerland. Self-stigma and the cognitive appraisal of mental illness stigma as a stressor were measured at baseline among supported employment participants (N=116). These variables and work-related discrimination in the past year were assessed one year later (N=96). Compared with participants who did not find employment (N=30), those who worked without experiencing discrimination (N=25) had lower levels of self-stigma and stigma stress at one year. Among those who worked and reported work-related discrimination (N=38), these measures did not decrease significantly. Experiencing discrimination at work may determine whether employment has positive effects in terms of self-stigma and stigma stress among individuals with mental illness. Interventions to reduce discrimination in work settings and to improve coping resources of these individuals could augment the positive effects of supported employment.

Supporting Adolescents with Guidance and Employment (SAGE).

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Ringwalt, C L; Graham, L A; Paschall, M J; Flewelling, R L; Browne, D C

1996-01-01

Supporting Adolescents with Guidance and Employment (SAGE) is a multifaceted, community-based violence-prevention program. Its target is African-American male adolescents in Durham, North Carolina. Public health professionals, county government officials, and local businessmen collaborated in its development and implementation. The program is based on the paradigm of risk and protective factors, in which various risk factors for youth violence are buffered by modifiable, protective psychosocial processes. SAGE includes an eight-month African-American Rites of Passage program (adult mentoring, African-American culture and history lessons, and manhood and conflict-resolution training), a six-week summer employment component, and a 12-week entrepreneurial experience. Of the 260 youth recruited, 88 were randomly assigned to receive all three program components, 85 were assigned to the summer employment and entrepreneurial components only, and 87 were assigned to a delayed program or control condition. We compared these three groups' psychosocial and behavioral outcomes using survey data and archival records. Program implementation data include attendance records; mentor-youth activity logs pre- and postprogram focus group discussions; and telephone interviews with parents, program staff, and participants. The mean age of the adolescents recruited into the program was 14. Half reported receiving free lunches at school; half were not living with a father; and one quarter reported that their mothers had not completed high school. During the previous year, many had engaged in various violence-related behaviors, including fighting (49%) and carrying a gun (22%). Youths in each program condition were similar with respect to key demographic and behavioral characteristics. The key components of the SAGE program represent increasingly popular but untested approaches. Preliminary results reveal that these youths are involved in violent behavior both as perpetrators and as

Tablet computers versus optical aids to support education and learning in children and young people with low vision: protocol for a pilot randomised controlled trial, CREATE (Children Reading with Electronic Assistance To Educate).

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Crossland, Michael D; Thomas, Rachel; Unwin, Hilary; Bharani, Seelam; Gothwal, Vijaya K; Quartilho, Ana; Bunce, Catey; Dahlmann-Noor, Annegret

2017-06-21

Low vision and blindness adversely affect education and independence of children and young people. New 'assistive' technologies such as tablet computers can display text in enlarged font, read text out to the user, allow speech input and conversion into typed text, offer document and spreadsheet processing and give access to wide sources of information such as the internet. Research on these devices in low vision has been limited to case series. We will carry out a pilot randomised controlled trial (RCT) to assess the feasibility of a full RCT of assistive technologies for children/young people with low vision. We will recruit 40 students age 10-18 years in India and the UK, whom we will randomise 1:1 into two parallel groups. The active intervention will be Apple iPads; the control arm will be the local standard low-vision aid care. Primary outcomes will be acceptance/usage, accessibility of the device and trial feasibility measures (time to recruit children, lost to follow-up). Exploratory outcomes will be validated measures of vision-related quality of life for children/young people as well as validated measures of reading and educational outcomes. In addition, we will carry out semistructured interviews with the participants and their teachers. NRES reference 15/NS/0068; dissemination is planned via healthcare and education sector conferences and publications, as well as via patient support organisations. NCT02798848; IRAS ID 179658, UCL reference 15/0570. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Glasgow supported self-management trial (GSuST) for patients with moderate to severe COPD: randomised controlled trial.

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Bucknall, C E; Miller, G; Lloyd, S M; Cleland, J; McCluskey, S; Cotton, M; Stevenson, R D; Cotton, P; McConnachie, A

2012-03-06

To determine whether supported self management in chronic obstructive pulmonary disease (COPD) can reduce hospital readmissions in the United Kingdom. Randomised controlled trial. Community based intervention in the west of Scotland. Patients admitted to hospital with acute exacerbation of COPD. Participants in the intervention group were trained to detect and treat exacerbations promptly, with ongoing support for 12 months. The primary outcome was hospital readmissions and deaths due to COPD assessed by record linkage of Scottish Morbidity Records; health related quality of life measures were secondary outcomes. 464 patients were randomised, stratified by age, sex, per cent predicted forced expiratory volume in 1 second, recent pulmonary rehabilitation attendance, smoking status, deprivation category of area of residence, and previous COPD admissions. No difference was found in COPD admissions or death (111/232 (48%) v 108/232 (47%); hazard ratio 1.05, 95% confidence interval 0.80 to 1.38). Return of health related quality of life questionnaires was poor (n=265; 57%), so that no useful conclusions could be made from these data. Pre-planned subgroup analysis showed no differential benefit in the primary outcome relating to disease severity or demographic variables. In an exploratory analysis, 42% (75/150) of patients in the intervention group were classified as successful self managers at study exit, from review of appropriateness of use of self management therapy. Predictors of successful self management on stepwise regression were younger age (P=0.012) and living with others (P=0.010). COPD readmissions/deaths were reduced in successful self managers compared with unsuccessful self managers (20/75 (27%) v 51/105 (49%); hazard ratio 0.44, 0.25 to 0.76; P=0.003). Supported self management had no effect on time to first readmission or death with COPD. Exploratory subgroup analysis identified a minority of participants who learnt to self manage; this group had a

Investigating the cost-effectiveness of videotelephone based support for newly diagnosed paediatric oncology patients and their families: design of a randomised controlled trial

Directory of Open Access Journals (Sweden)

Theodoros Deborah

2007-03-01

Full Text Available Abstract Background Providing ongoing family centred support is an integral part of childhood cancer care. For families living in regional and remote areas, opportunities to receive specialist support are limited by the availability of health care professionals and accessibility, which is often reduced due to distance, time, cost and transport. The primary aim of this work is to investigate the cost-effectiveness of videotelephony to support regional and remote families returning home for the first time with a child newly diagnosed with cancer Methods/design We will recruit 162 paediatric oncology patients and their families to a single centre randomised controlled trial. Patients from regional and remote areas, classified by Accessibility/Remoteness Index of Australia (ARIA+ greater than 0.2, will be randomised to a videotelephone support intervention or a usual support control group. Metropolitan families (ARIA+ ≤ 0.2 will be recruited as an additional usual support control group. Families allocated to the videotelephone support intervention will have access to usual support plus education, communication, counselling and monitoring with specialist multidisciplinary team members via a videotelephone service for a 12-week period following first discharge home. Families in the usual support control group will receive standard care i.e., specialist multidisciplinary team members provide support either face-to-face during inpatient stays, outpatient clinic visits or home visits, or via telephone for families who live far away from the hospital. The primary outcome measure is parental health related quality of life as measured using the Medical Outcome Survey (MOS Short Form SF-12 measured at baseline, 4 weeks, 8 weeks and 12 weeks. The secondary outcome measures are: parental informational and emotional support; parental perceived stress, parent reported patient quality of life and parent reported sibling quality of life, parental satisfaction

Employee and employer support for workplace-based smoking cessation: results from an international survey.

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Halpern, Michael T; Taylor, Humphrey

2010-01-01

Workplace smoking cessation programs can increase smoking cessation rates, improve employee health, reduce exposure to second-hand smoke, and decrease costs. To assist with the development of such programs, we conducted a Global Workplace Smoking Survey to collect information on workplace attitudes towards smoking cessation programs. Data were collected from 1,403 employers (smoking and non-smoking) and 3,525 smoking employees participating in surveys in 14 countries in Asia, Europe, and South America in 2007. Results were weighted to ensure that they were representative of smokers and employers at companies with the specified number of employees. More than two-thirds of employers (69%) but less than half of employees (48%) indicated that their company should help employees with smoking cessation. Approximately two-thirds of employees and 81% of employers overall felt that smoke-free policies encourage cessation, but fewer individuals from Europe (vs. from Asia or South America) agreed with this. In companies with a smoke-free policy, 76% of employees and 80% of employers felt that their policy had been somewhat, very, or extremely effective in motivating employees to quit or reduce smoking. Employers and employees differed substantially regarding appropriate methods for encouraging cessation, with more employees favouring financial incentives and more employers favouring education. Both employees and employers value smoke-free workplace programs and workplace cessation support activities, although many would like their companies to offer more support. These results will be useful for organizations exploring means of facilitating smoking cessation amongst employees.

The development of supported employment services for people with mental illness: local experience in Hong Kong.

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Chiu, Frank P.F.

2000-01-01

Before the 1960s in Hong Kong, specialized vocational services for people with mental illness were very limited, and sheltered workshop seemed to be the only option for their future vocational placement at that time. As discussed in the literature, there are still many shortcomings of the sheltered workshop model, that brings us to the emergence of another community-based vocational service: Supported Employment. Unlike traditional vocational services, the concept of supported employment emphasizes the placing of the clients into integrated work environments and then providing on-going support and work-related skills training in the job post. Though supported employment services help many clients to sustain a job in the competitive market, many service barriers and problems still remain unsolved. These service barriers and problems will be discussed in this article, and suggestions will be made.

Staff training and outreach support for Cognitive Stimulation Therapy and its implementation in practice: a cluster randomised trial.

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Streater, Amy; Spector, Aimee; Hoare, Zoe; Aguirre, Elisa; Russell, Ian; Orrell, Martin

2017-12-01

There is evidence that Cognitive Stimulation Therapy and maintenance Cognitive Stimulation Therapy are effective in mild to moderate dementia. There is, however, little evidence available for its implementation in practice and the impact of outreach support on the sustainability of the programme. Two hundred and forty-one staff members were randomised from 63 dementia care settings between outreach support including an online forum, email, and telephone support, compared to usual Cognitive Stimulation Therapy control group. The primary outcome was average number of attendees to the Cognitive Stimulation Therapy and maintenance Cognitive Stimulation Therapy programmes. There was no difference in average number of attendees between the intervention and usual Cognitive Stimulation Therapy control groups for the Cognitive Stimulation Therapy (p = 0.82) or the maintenance Cognitive Stimulation Therapy programme (p = 0.97). Outreach support does not affect the average number of people with dementia attending the Cognitive Stimulation Therapy or maintenance Cognitive Stimulation Therapy programme. Irrespective of outreach support, the programmes remain widely implemented and yield perceived benefits for people with dementia. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Work, family, support, and depression: employed mothers in Israel, Korea, and the United States.

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O'Brien, Karen M; Ganginis Del Pino, Heather V; Yoo, Sung-Kyung; Cinamon, Rachel Gali; Han, Young-Joo

2014-07-01

Our research revealed differences in work-family constructs for employed mothers in 3 countries, Israel (N = 105), Korea (N = 298), and the United States (N = 305). Although levels of work-family conflict were comparable, the Korean women had the lowest levels of work-family enrichment compared with the Israeli and American mothers. Moreover, Korean women reported the most depression and the least support from both spouses and employers. Spousal support mediated the relationship between work-family conflict and depression for employed mothers in Israel, Korea, and the United States. As hypothesized by conservation of resources theory (Hobfoll, 1989, 1998, 2001), threat of resource loss (operationalized as work-family conflict) was related to depression more strongly than was resource gain (i.e., work-family enrichment). PsycINFO Database Record (c) 2014 APA, all rights reserved.

Discontinuation and non-publication of randomised clinical trials supported by the main public funding body in Switzerland: a retrospective cohort study.

Science.gov (United States)

Amstutz, Alain; Schandelmaier, Stefan; Frei, Roy; Surina, Jakub; Agarwal, Arnav; Olu, Kelechi Kalu; Alturki, Reem; Von Niederhäusern, Belinda; Von Elm, Erik; Briel, Matthias

2017-08-01

The Swiss National Science Foundation (SNSF) promotes academic excellence through competitive selection of study proposals and rigorous evaluation of feasibility, but completion status and publication history of SNSF-supported randomised clinical trials (RCTs) remain unclear. The main objectives were to review all healthcare RCTs supported by the SNSF for trial discontinuation and non-publication, to investigate potential risk factors for trial discontinuation due to poor recruitment and non-publication, and to compare findings to other Swiss RCTs not supported by the SNSF. We established a retrospective cohort of all SNSF-supported RCTs for which recruitment and funding had ended in 2015 or earlier. For each RCT, two investigators independently searched corresponding publications in electronic databases. In addition, we approached all principal investigators to ask for additional publications and information about trial discontinuation. Teams of two investigators independently extracted details about study design, recruitment of participants, outcomes, analysis and sample size from the original proposal and, if available, from trial registries and publications. We used multivariable regression analysis to explore potential risk factors associated with discontinuation due to poor recruitment and with non-publication, and to compare our results with data from a previous cohort of Swiss RCTs not supported by the SNSF. We included 101 RCTs supported by the SNSF between 1986 and 2015. Eighty-seven (86%) principal investigators responded to our survey. Overall, 69 (68%) RCTs were completed, 26 (26%) RCTs were prematurely discontinued (all due to slow recruitment) and the completion status remained unclear for 6 (6%) RCTs. For analysing publication status, we excluded 4 RCTs for which follow-up was still ongoing and 9 for which manuscripts were still in preparation. Of the remaining 88 RCTs, 53 (60%) were published as full articles in peer-reviewed journals

Use of the learning conversation improves instructor confidence in life support training: An open randomised controlled cross-over trial comparing teaching feedback mechanisms.

Science.gov (United States)

Baldwin, Lydia J L; Jones, Christopher M; Hulme, Jonathan; Owen, Andrew

2015-11-01

Feedback is vital for the effective delivery of skills-based education. We sought to compare the sandwich technique and learning conversation structured methods of feedback delivery in competency-based basic life support (BLS) training. Open randomised crossover study undertaken between October 2014 and March 2015 at the University of Birmingham, United Kingdom. Six-hundred and forty healthcare students undertaking a European Resuscitation Council (ERC) BLS course were enrolled, each of whom was randomised to receive teaching using either the sandwich technique or the learning conversation. Fifty-eight instructors were randomised to initially teach using either the learning conversation or sandwich technique, prior to crossing-over and teaching with the alternative technique after a pre-defined time period. Outcome measures included skill acquisition as measured by an end-of-course competency assessment, instructors' perception of teaching with each feedback technique and candidates' perception of the feedback they were provided with. Scores assigned to use of the learning conversation by instructors were significantly more favourable than for the sandwich technique across all but two assessed domains relating to instructor perception of the feedback technique, including all skills-based domains. No difference was seen in either assessment pass rates (80.9% sandwich technique vs. 77.2% learning conversation; OR 1.2, 95% CI 0.85-1.84; p=0.29) or any domain relating to candidates' perception of their teaching technique. This is the first direct comparison of two feedback techniques in clinical medical education using both quantitative and qualitative methodology. The learning conversation is preferred by instructors providing competency-based life support training and is perceived to favour skills acquisition. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

75 FR 58277 - National Employer Support of the Guard and Reserve Week, 2010

Science.gov (United States)

2010-09-23

... special tribute to the employers of our Guardsmen and Reservists, whose support and flexibility bolster... encourage National Guard and Reserve participation, and by bearing financial and organizational...

When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework.

Science.gov (United States)

Jull, J; Whitehead, M; Petticrew, M; Kristjansson, E; Gough, D; Petkovic, J; Volmink, J; Weijer, C; Taljaard, M; Edwards, S; Mbuagbaw, L; Cookson, R; McGowan, J; Lyddiatt, A; Boyer, Y; Cuervo, L G; Armstrong, R; White, H; Yoganathan, M; Pantoja, T; Shea, B; Pottie, K; Norheim, O; Baird, S; Robberstad, B; Sommerfelt, H; Asada, Y; Wells, G; Tugwell, P; Welch, V

2017-09-25

Randomised controlled trials can provide evidence relevant to assessing the equity impact of an intervention, but such information is often poorly reported. We describe a conceptual framework to identify health equity-relevant randomised trials with the aim of improving the design and reporting of such trials. An interdisciplinary and international research team engaged in an iterative consensus building process to develop and refine the conceptual framework via face-to-face meetings, teleconferences and email correspondence, including findings from a validation exercise whereby two independent reviewers used the emerging framework to classify a sample of randomised trials. A randomised trial can usefully be classified as 'health equity relevant' if it assesses the effects of an intervention on the health or its determinants of either individuals or a population who experience ill health due to disadvantage defined across one or more social determinants of health. Health equity-relevant randomised trials can either exclusively focus on a single population or collect data potentially useful for assessing differential effects of the intervention across multiple populations experiencing different levels or types of social disadvantage. Trials that are not classified as 'health equity relevant' may nevertheless provide information that is indirectly relevant to assessing equity impact, including information about individual level variation unrelated to social disadvantage and potentially useful in secondary modelling studies. The conceptual framework may be used to design and report randomised trials. The framework could also be used for other study designs to contribute to the evidence base for improved health equity. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

An evaluation of an employment pilot to support forensic mental health service users into work and vocational activities.

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Samele, Chiara; Forrester, Andrew; Bertram, Mark

2018-02-01

Few employment programmes exist to support forensic service users with severe mental health problems and a criminal history. Little is known about how best to achieve this. The Employment and Social Inclusion Project (ESIP) was developed and piloted to support forensic service users into employment and vocational activities. This pilot service evaluation aimed to assess the number of service users who secured employment/vocational activities and explored services users' and staff experiences. Quantitative data were collected to record the characteristics of participating service users and how many secured employment and engaged in vocational activities. Eighteen qualitative interviews were conducted with service users and staff. Fifty-seven service users engaged with the project, most were men (93.0%) and previously employed (82.5%). Four service users (7.0%) secured paid competitive employment. Eight (14.0%) gained other paid employment. Tailored one-to-one support to increase skills and build confidence was an important feature of the project. Creation of a painting and decorating programme offered training and paid/flexible work. This exploratory project achieved some success in assisting forensic service users into paid employment. Further research to identify what works well for this important group will be of great value.

Randomised feasibility study of a novel experience-based internet intervention to support self-management in chronic asthma.

Science.gov (United States)

Newhouse, Nikki; Martin, Angela; Jawad, Sena; Yu, Ly-Mee; Davoudianfar, Mina; Locock, Louise; Ziebland, Sue; Powell, John

2016-12-28

To determine the feasibility of a randomised controlled trial (RCT) assessing the effects of an experience-based website as a resource for the self-management of chronic asthma. Feasibility, single-blind RCT in 2 regions of England. Randomisation used computer-generated random number sequence in a 1:1 ratio, after baseline data collection, to website access for 2 weeks. Adults (age ≥18 years), with clinically diagnosed asthma as coded in their primary care electronic record, prescribed inhaled corticosteroids for at least 3 months in the previous year, were recruited from 9 general practices. The EXPERT asthma intervention is an interactive PC/laptop/tablet/smartphone compatible website designed with extensive input from adults with asthma. It provides experience-based information and aims to support subjective perception of self-efficacy, self-management and improve health status. Primary outcomes were consent/recruitment, website usage and completion of outcome measures. Secondary outcomes included Partners in Health (PIH) questionnaire, the Chronic Disease Self-Efficacy Scale, the SF36 and the E-Health Impact Questionnaire. Participant blinding postrandomisation was not possible. The analysis was blind to allocation. Recruitment target exceeded. 148 participants randomised (73 intervention group). Age range 19-84 years; 59% female. 121 of 148 (84%; 62 intervention group) followed up. The median number of logins was 2 (IQR 2-3, range 1-48). Minimal differences of change from baseline between groups; both showed improvement in health state or management of their condition with no significant differences between arms. No adverse events. Recruitment and retention confirmed feasibility. The trends towards improved outcomes suggest that further research on digital interventions based on exposure to others' personal experiences may be of value in the self-management of chronic asthma. ISRCTN29549695; Results. Published by the BMJ Publishing Group Limited. For

The role of work related self-efficacy in supported employment for people living with serious mental illnesses.

Science.gov (United States)

Waynor, William R; Gill, Kenneth J; Gao, Ni

2016-03-01

This study tested whether higher work-related self-efficacy would predict the achievement of competitive employment in supported employment (SE) programs. N = 105 individuals were recruited from 5 state-funded SE programs in a Northeastern state. Participants were required to be unemployed and seeking employment to be eligible to enter the study. Research staff met with the individuals at baseline and collected demographic information and data on self-efficacy and psychiatric symptoms. For the follow-up assessment at 6 months, data were collected on participants, self-efficacy, psychiatric symptoms, and employment activity. Thirty-eight percent of the participants achieved competitive employment at the 6-month follow-up. However, self-efficacy was not a positive predictor of competitive employment. Surprisingly, 1 of the subscales, work-related social skills self-efficacy, was negatively associated with employment. These findings suggest that self-efficacy is not a predictor of competitive employment for individuals living with serious mental illness and receiving supported employment services. It appears that SE can be helpful for participants with a range of self-efficacy. (c) 2016 APA, all rights reserved).

77 FR 58295 - National Employer Support of the Guard and Reserve Week, 2012

Science.gov (United States)

2012-09-19

... of happiness were first put to paper, ordinary citizens have always stood ready to defend them as... a culture of military support in the workplace. These employers help keep our service members...

Improving Work Outcome in Supported Employment for Serious Mental Illness: Results From 2 Independent Studies of Errorless Learning.

Science.gov (United States)

Kern, Robert S; Zarate, Roberto; Glynn, Shirley M; Turner, Luana R; Smith, Kellie M; Mitchell, Sharon S; Sugar, Catherine A; Bell, Morris D; Liberman, Robert P; Kopelowicz, Alex; Green, Michael F

2018-01-13

Heterogeneity in work outcomes is common among individuals with serious mental illness (SMI). In 2 studies, we sought to examine the efficacy of adding errorless learning, a behavioral training intervention, to evidence-based supported employment to improve SMI work outcomes. Work behavior problems were targeted for intervention. We also explored associations between early work behavior and job tenure. For both studies (VA: n = 71; community mental health center: n = 91), randomization occurred at the time of job obtainment with participants randomized (1:1) to either errorless learning plus ongoing supported employment or ongoing supported employment alone and then followed for 12 months. Dependent variables included job tenure, work behavior, and hours worked and wages earned per week. For the primary intent-to-treat analyses, data were combined across studies. Findings revealed that participants in the errorless learning plus supported employment group stayed on their jobs significantly longer than those in the supported employment alone group (32.8 vs 25.6 wk). In addition, differential treatment effects favoring errorless learning were found on targeted work behavior problems (50.5% vs 27.4% improvement from baseline to follow-up assessment). There were no other differential treatment effects. For the prediction analyses involving work behavior, social skills explained an additional 18.3% of the variance in job tenure beyond levels of cognition, symptom severity, and past work history. These data support errorless learning as an adjunctive intervention to enhance supported employment outcomes and implicate the relevance of workplace social difficulties as a key impediment to prolonged job tenure. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center 2017.

Gym-based exercise and home-based exercise with telephone support have similar outcomes when used as maintenance programs in adults with chronic health conditions: a randomised trial

Directory of Open Access Journals (Sweden)

Paul Jansons

2017-07-01

Trial registration: ACTRN12610001035011. [Jansons P, Robins L, O’Brien L, Haines T (2017 Gym-based exercise and home-based exercise with telephone support have similar outcomes when used as maintenance programs in adults with chronic health conditions: a randomised trial. Journal of Physiotherapy 63: 154–160

Worksite Food and Physical Activity Environments and Wellness Supports Reported by Employed Adults in the United States, 2013.

Science.gov (United States)

Onufrak, Stephen J; Watson, Kathleen B; Kimmons, Joel; Pan, Liping; Khan, Laura Kettel; Lee-Kwan, Seung Hee; Park, Sohyun

2018-01-01

To examine the workplace food and physical activity (PA) environments and wellness culture reported by employed United States adults, overall and by employer size. Cross-sectional study using web-based survey on wellness policies and environmental supports for healthy eating and PA. Worksites in the United States. A total of 2101 adults employed outside the home. Survey items were based on the Centers for Disease Control and Prevention Worksite Health ScoreCard and Checklist of Health Promotion Environments and included the availability and promotion of healthy food items, nutrition education, promotion of breast-feeding, availability of PA amenities and programs, facility discounts, time for PA, stairwell signage, health promotion programs, and health risk assessments. Descriptive statistics were used to examine the prevalence of worksite environmental and facility supports by employer size (<100 or ≥100 employees). Chi-square tests were used to examine the differences by employer size. Among employed respondents with workplace food or drink vending machines, approximately 35% indicated the availability of healthy items. Regarding PA, 30.9% of respondents reported that their employer provided opportunities to be physically active and 17.6% reported worksite exercise facilities. Wellness programs were reported by 53.2% working for large employers, compared to 18.1% for smaller employers. Employee reports suggested that workplace supports for healthy eating, PA, and wellness were limited and were less common among smaller employers.

Vibration therapy reduces CPAP need in a prospective randomised controlled trial

NARCIS (Netherlands)

K. Helder MScN (Onno); W.C.J. Hop (Wim); J.B. van Goudoever (Hans)

2008-01-01

textabstractBackground: Increased mucus production is a common phenomena following ventilatory support, which might increase morbidity. In order to reduce airway obstruction we tested the effect of vibration therapy on the duration of ventilatory support. Methodology: We conducted a randomised

Protocol for an online randomised controlled trial to evaluate the clinical and cost-effectiveness of a peer-supported self-management intervention for relatives of people with psychosis or bipolar disorder: Relatives Education And Coping Toolkit (REACT).

Science.gov (United States)

Lobban, Fiona; Robinson, Heather; Appelbe, Duncan; Barraclough, Johanna; Bedson, Emma; Collinge, Lizzi; Dodd, Susanna; Flowers, Sue; Honary, Mahsa; Johnson, Sonia; Mateus, Ceu; Mezes, Barbara; Minns, Valerie; Murray, Elizabeth; Walker, Andrew; Williamson, Paula; Wintermeyer, Catherine; Jones, Steven

2017-07-18

Despite clinical guidelines recommendations, many relatives of people with psychosis or bipolar disorder do not currently receive the support they need. Online information and support may offer a solution. This single-blind, parallel, online randomised controlled trial will determine clinical and cost-effectiveness of the Relatives Education And Coping Toolkit (REACT) (including an online resource directory (RD)), compared with RD only, for relatives of people with psychosis or bipolar disorder. Both groups continue to receive treatment as usual. Independent, web-based variable, block, individual randomisation will be used across 666 relatives. Primary outcome is distress at 24 weeks (measured by General Health Questionnaire; GHQ-28) compared between groups using analysis of covariance, adjusting for baseline score. Secondary clinical outcomes are carer well-being and support. Cost-effectiveness analysis will determine cost of a significant unit change (three-point reduction) in the GHQ-28. Costs include offering and supporting the intervention in the REACT arm, relevant healthcare care costs including health professional contacts, medications prescribed and time off (or ability to) work for the relative. Cost utility analysis will be calculated as the marginal cost of changes in quality-adjusted life years, based on EuroQol. We will explore relatives' beliefs, perceived coping and amount of REACT toolkit use as possible outcome mediators. We have embedded two methodological substudies in the protocol to determine the relative effectiveness of a low-value (£10) versus higher value (£20) incentive, and an unconditional versus conditional incentive, on improving follow-up rates. The trial has ethical approval from Lancaster National Research Ethics Service (NRES)Committee (15/NW/0732) and is overseen by an independent Data Monitoring and Ethics Committee and Trial Steering Committee. Protocol version 1.5 was approved on 9 January 2017. All updates to protocols are

The effect of pre-course e-learning prior to advanced life support training: a randomised controlled trial.

Science.gov (United States)

Perkins, Gavin D; Fullerton, James N; Davis-Gomez, Nicole; Davies, Robin P; Baldock, Catherine; Stevens, Harry; Bullock, Ian; Lockey, Andrew S

2010-07-01

The role of e-learning in contemporary healthcare education is quickly developing. The aim of this study was to examine the relationship between the use of an e-learning simulation programme (Microsim, Laerdal, UK) prior to attending an Advanced Life Support (ALS) course and the subsequent relationship to candidate performance. An open label, multi-centre randomised controlled study was conducted. The control group received a course manual and pre-course MCQ four weeks prior to the face to face course. The intervention group in addition received the Microsim programme on a CD. The primary outcome was performance during a simulated cardiac arrest at the end of the course. Secondary outcomes were performance during multiple choice exams, resuscitation skills assessments and feedback to Microsim programme. 572 participants were randomised (287 Microsim, 285 control). There were no significant differences in the primary outcome (performance during a standard cardiac arrest simulation) or secondary outcomes. User evaluations were favorable. 79% would recommend it to colleagues. 9% stated Microsim could replace the entire ALS course, 25% parts. Over 70% of participants' perceived that Microsim improved their understanding of the key learning domains of the ALS course. Distributing Microsim to healthcare providers prior to attending an ALS courses did not improve either cognitive or psychomotor skills performance during cardiac arrest simulation testing. The challenge that lies ahead is to identify the optimal way to use e-learning as part of a blended approach to learning for this type of training programme.

Influence of Partner Support on an Employed Mother's Intention to Breastfeed After Returning to Work

Science.gov (United States)

2014-01-01

Abstract Background: Despite the increasing number of large companies complying with the demands for a breastfeeding-friendly workplace, providing on-site lactation support, some mothers still find continuing to breastfeed a challenge. We postulated that greater support and encouragement from the partner would be independently predictive of whether the mother would take advantage of workplace milk expression breaks and lactation rooms and continue to breastfeed after returning to work. To evaluate this hypothesis, we conducted a survey at a female labor-intensive electronics manufacturer in Taiwan. Subjects and Methods: Six hundred eight working mothers in an electronics manufacturing plant in Tainan Science Park in Southern Taiwan who had access to dedicated lactation rooms at the workplace were interviewed. Questionnaire content included female employee demographics, employment characteristics, partner-related characteristics, and breastfeeding behavior after returning to work following the birth of their most recently born child. Results: The partner's initial support of the choice to breastfeed and encouragement to use the lactation room and milk expression breaks and the mother's perception of the partner's support for baby care were significant predictors of the intention to continue to breastfeed after returning to work, after adjusting for the employed mother's demographics and employment characteristics, supporting our hypothesis. Conclusions: These findings suggest that antenatal education or activities provided by the workplace should include the partner, which may improve workplace breastfeeding rates. PMID:24650363

Hospital at Home care for older patients with cognitive impairment: a protocol for a randomised controlled feasibility trial.

Science.gov (United States)

Pouw, Maaike A; Calf, Agneta H; van Munster, Barbara C; Ter Maaten, Jan C; Smidt, Nynke; de Rooij, Sophia E

2018-03-27

An acute hospital admission is a stressful life event for older people, particularly for those with cognitive impairment. The hospitalisation is often complicated by hospital-associated geriatric syndromes, including delirium and functional loss, leading to functional decline and nursing home admission. Hospital at Home care aims to avoid hospitalisation-associated adverse outcomes in older patients with cognitive impairment by providing hospital care in the patient's own environment. This randomised, non-blinded feasibility trial aims to assess the feasibility of conducting a randomised controlled trial in terms of the recruitment, use and acceptability of Hospital at Home care for older patients with cognitive impairment. The quality of care will be evaluated and the advantages and disadvantages of the Hospital at Home care programme compared with usual hospital care. Eligible patients will be randomised either to Hospital at Home care in their own environment or usual hospital care. The intervention consists of hospital level care provided at patients' homes, including visits from healthcare professionals, diagnostics (laboratory tests, blood cultures) and treatment. The control group will receive usual hospital care. Measurements will be conducted at baseline, during admission, at discharge and at 3 and 6 months after the baseline assessment. Institutional ethics approval has been granted. The findings will be disseminated through public lectures, professional and scientific conferences, as well as peer-reviewed journal articles. The study findings will contribute to knowledge on the implementation of Hospital at Home care for older patients with cognitive disorders. The results will be used to inform and support strategies to deliver eligible care to older patients with cognitive impairment. e020313; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is

An 8 year follow-up of a specialist supported employment service for high-ability adults with autism or Asperger syndrome.

Science.gov (United States)

Howlin, Patricia; Alcock, Jennifer; Burkin, Catherine

2005-12-01

Few supported employment programmes have been specifically designed for people with autism, especially those who are more able. This study examines the outcome of a supported employment service (NAS Prospects) for adults with autism or Asperger syndrome (IQ 60+) over an 8 year period. Approximately 68 percent of clients found employment. Of the 192 jobs, the majority were permanent contracts and most involved administrative, technical or computing work. Assessment of current clients indicates that IQ, language skills and educational attainments are high. However, work has also been found for those of lower abilities. Individuals supported by Prospects show a rise in salaries, contribute more tax and claim fewer benefits. Satisfaction with the scheme is high among clients, employers and support workers. Although the programme continues to incur a financial deficit, this has decreased. Moreover, there are many non-financial benefits, which are difficult to quantify. The importance of specialist employment support of this kind is discussed.

Combining garden therapy and supported employment - a method for preparing women on long-term sick leave for working life.

Science.gov (United States)

Lidén, Eva; Alstersjö, Karin; Gurné, Frida L; Fransson, Sandra; Bergbom, Ingegerd

2016-06-01

Women are overrepresented among the group people suffering from long-term illness. In addition to their illness, suffering long-term sick leave leads to economical restraints as well social distress. There are gaps in our understanding of the challenges these women face. There is also lack of knowledge about how these challenges can be effectively addressed in rehabilitation. This deficiency is problematic from an ethical, justice and a caring perspective. In this study, changes in health-related quality of life (HRQoL) among women on long-term sick leave were investigated during and after participating in a rehabilitation programme combining two validated methods, Garden Therapy and Supported Employment (SE). The study also discusses difficulties in realising research related to vulnerable under-privileged people. From a population of 329 women who had reported their interest to participate, 245 were randomised to the programme. Of these 144 accepted participation in the research project and of these 123 women accepted to answer the SF-36 questionnaire. The participants were between 21 and 62 years with poor physical and mental health. They had received public financial support from 10 years. The SF-36 measurement was carried out at baseline, after completion of Garden Therapy and after completion of SE. The results are based on data of respondents who participated at all the three occasions (n = 52). When comparing HRQoL baseline with the following occasions, the participants' General Health (GH), Vitality (VT), Social Functioning (SF) and mental health had improved significantly. The Four Leaf Clover (FLC) programme could be an appropriate method for reducing socially induced suffering. However, to conduct intervention studies where vulnerable persons are involved, it is off vital importance to consider whether the participants have the strength to complete the intervention. © 2015 Nordic College of Caring Science.

A pilot cluster randomised controlled trial of a support and training intervention to improve the mental health of secondary school teachers and students - the WISE (Wellbeing in Secondary Education) study.

Science.gov (United States)

Kidger, Judi; Stone, Tracey; Tilling, Kate; Brockman, Rowan; Campbell, Rona; Ford, Tamsin; Hollingworth, William; King, Michael; Araya, Ricardo; Gunnell, David

2016-10-06

Secondary school teachers are at heightened risk of psychological distress, which can lead to poor work performance, poor quality teacher-student relationships and mental illness. A pilot cluster randomised controlled trial (RCT) - the WISE study - evaluated the feasibility of a full-scale RCT of an intervention to support school staff's own mental health, and train them in supporting student mental health. Six schools were randomised to an intervention or control group. In the intervention schools i) 8-9 staff received Mental Health First Aid (MHFA) training and became staff peer supporters, and ii) youth MHFA training was offered to the wider staff body. Control schools continued with usual practice. We used thematic qualitative data analysis and regression modelling to ascertain the feasibility, acceptability and potential usefulness of the intervention. Thirteen training observations, 14 staff focus groups and 6 staff interviews were completed, and 438 staff (43.5 %) and 1,862 (56.3 %) students (years 8 and 9) completed questionnaires at baseline and one year later. MHFA training was considered relevant for schools, and trainees gained in knowledge, confidence in helping others, and awareness regarding their own mental health. Suggestions for reducing the length of the training and focusing on helping strategies were made. A peer support service was established in all intervention schools and was perceived to be helpful in supporting individuals in difficulty - for example through listening, and signposting to other services - and raising the profile of mental health at a whole school level. Barriers to use included lack of knowledge about the service, concerns about confidentiality and a preference for accessing support from pre-existing networks. The WISE intervention is feasible and acceptable to schools. Results support the development of a full-scale cluster RCT, if steps are taken to improve response rates and implement the suggested improvements to the

Farmers as Employers. Numeracy. Level 1. Level 2. Level 3. Support Materials for Agricultural Training.

Science.gov (United States)

Batman, Kangan; Tully, Chris

This publication contains the three numeracy units of the three levels of Support Materials for Agricultural Training (SMAT) in the area of farmers as employers: Level 1 (starting), 2 (continuing), and 3 (completing). The units are designed to help the learner improve his or her numeracy skills needed to deal with employment of agriculture…

Work-family conflict, perceived organizational support, and organizational commitment among employed mothers.

Science.gov (United States)

Casper, Wendy J; Martin, Jennifer A; Buffardi, Louis C; Erdwins, Carol J

2002-04-01

This study investigated the impact of work interfering with family (WIF) and family interfering with work (FIW) on women's organizational commitment and examined both the direct and moderating effects of their perceived organizational support. Participants were 143 professional employed mothers with at least 1 preschool-age child. The study found that WIF was positively related to continuance organizational commitment but unrelated to affective commitment, and FIW was not related to either form of organizational commitment. Results also indicated that perceived organizational support exhibited a main effect on both types of commitment.

Supporting the Transition into Employment: A Study of Canadian Young Adults Living with Disabilities.

Science.gov (United States)

Jetha, Arif; Bowring, Julie; Furrie, Adele; Smith, Frank; Breslin, Curtis

2018-04-25

Objective To examine the job accommodation and benefit needs of young adults with disabilities as they transition into employment, and their perceived barriers to meeting support needs. Methods An online survey was conducted of 155 Canadian young adults with disabilities (mean age = 25.8 years). Respondents were either employed or seeking employment, and were asked about their need for health benefits, and soft (e.g., flexible scheduling) and hard accommodations (e.g., ergonomic interventions), and perceived accommodation barriers. Disability characteristics (e.g., disability type), demographic details and work context information were collected. Multivariable logistic analyses were conducted to examine the factors associated with a greater need for health benefits and hard and soft accommodations. Result Participants reported having a physical (79%), psychological (79%) or cognitive/learning disability (77%); 68% had > 1 disability. Over half (55%) were employed. Health benefits and soft accommodations were most needed by participants. Also, an average of six perceived accommodation barriers were indicated; difficulty with disability disclosure was most frequently reported. More perceived accommodation barriers were associated with a greater need for health benefits (OR 1.17, 95% CI 1.04-1.31) and soft accommodations (OR 1.13, 95% CI 1.01-1.27). A psychological disability was a associated with a greater need for health benefits (OR 2.91, 95% CI 1.09-7.43) and soft accommodations (OR 3.83, 95% CI 1.41-10.42). Discussion Employers can support the employment of young adults with disabilities through provision of extended health benefits and soft accommodations. Addressing accommodation barriers could minimize unmet workplace need, and improve employment outcomes for young adults with disabilities as they begin their career and across the life course.

A pilot cluster randomised controlled trial of a support and training intervention to improve the mental health of secondary school teachers and students – the WISE (Wellbeing in Secondary Education study

Directory of Open Access Journals (Sweden)

Judi Kidger

2016-10-01

Full Text Available Abstract Background Secondary school teachers are at heightened risk of psychological distress, which can lead to poor work performance, poor quality teacher-student relationships and mental illness. A pilot cluster randomised controlled trial (RCT – the WISE study – evaluated the feasibility of a full-scale RCT of an intervention to support school staff’s own mental health, and train them in supporting student mental health. Methods Six schools were randomised to an intervention or control group. In the intervention schools i 8–9 staff received Mental Health First Aid (MHFA training and became staff peer supporters, and ii youth MHFA training was offered to the wider staff body. Control schools continued with usual practice. We used thematic qualitative data analysis and regression modelling to ascertain the feasibility, acceptability and potential usefulness of the intervention. Results Thirteen training observations, 14 staff focus groups and 6 staff interviews were completed, and 438 staff (43.5 % and 1,862 (56.3 % students (years 8 and 9 completed questionnaires at baseline and one year later. MHFA training was considered relevant for schools, and trainees gained in knowledge, confidence in helping others, and awareness regarding their own mental health. Suggestions for reducing the length of the training and focusing on helping strategies were made. A peer support service was established in all intervention schools and was perceived to be helpful in supporting individuals in difficulty – for example through listening, and signposting to other services - and raising the profile of mental health at a whole school level. Barriers to use included lack of knowledge about the service, concerns about confidentiality and a preference for accessing support from pre-existing networks. Conclusions The WISE intervention is feasible and acceptable to schools. Results support the development of a full-scale cluster RCT, if steps are taken to

Reported challenges in nurse-led randomised controlled trials

DEFF Research Database (Denmark)

Wang Vedelø, Tina; Lomborg, Kirsten

2011-01-01

Aims: The purpose of this integrative literature review was to explore and discuss the methodological challenges nurse researchers report after conducting nurse-led randomised controlled trials in clinical hospital settings. Our research questions were (i) what are the most commonly experienced...... and the clinical nursing staff. Two lessons learned from this integrative review can be highlighted. First, we recommend researchers openly to share their experiences of barriers and challenges. They should describe factors that may have inhibited the desired outcome. Second, efforts to improve the collaboration...... between nurse researchers and clinicians, including education, training and support may increase the success rate and quality of nurse-led studies using the randomised controlled trial....

Protocol for a cluster randomised controlled trial of an intervention to improve the mental health support and training available to secondary school teachers - the WISE (Wellbeing in Secondary Education) study.

Science.gov (United States)

Kidger, Judi; Evans, Rhiannon; Tilling, Kate; Hollingworth, William; Campbell, Rona; Ford, Tamsin; Murphy, Simon; Araya, Ricardo; Morris, Richard; Kadir, Bryar; Moure Fernandez, Aida; Bell, Sarah; Harding, Sarah; Brockman, Rowan; Grey, Jill; Gunnell, David

2016-10-18

Teachers are reported to be at increased risk of common mental health disorders compared to other occupations. Failure to support teachers adequately may lead to serious long-term mental disorders, poor performance at work (presenteeism), sickness absence and health-related exit from the profession. It also jeopardises student mental health, as distressed staff struggle to develop supportive relationships with students, and such relationships are protective against student depression. A number of school-based trials have attempted to improve student mental health, but these have mostly focused on classroom based approaches and have failed to establish effectiveness. Only a few studies have introduced training for teachers in supporting students, and none to date have included a focus on improving teacher mental health. This paper sets out the protocol (version 4.4 20/07/16) for a study aiming to address this gap. Cluster randomised controlled trial with secondary schools as the unit of randomisation. Intervention schools will receive: i) Mental Health First Aid (MHFA) training for a group of staff nominated by their colleagues, after which they will set up a confidential peer support service for colleagues ii) training in MHFA for schools and colleges for a further group of teachers, which will equip them to more effectively support student mental health iii) a short mental health awareness raising session and promotion of the peer support service for all teachers. Comparison schools will continue with usual practice. The primary outcome is teacher wellbeing measured using the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS). Secondary outcomes are teacher depression, absence and presenteeism, and student wellbeing, mental health difficulties, attendance and attainment. Measures will be taken at baseline, one year follow up (teachers only) and two year follow up. Economic and process evaluations will be embedded within the study. This study will establish the

Professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study.

Science.gov (United States)

Gattrell, William T; Hopewell, Sally; Young, Kate; Farrow, Paul; White, Richard; Wager, Elizabeth; Winchester, Christopher C

2016-02-21

Authors may choose to work with professional medical writers when writing up their research for publication. We examined the relationship between medical writing support and the quality and timeliness of reporting of the results of randomised controlled trials (RCTs). Cross-sectional study. Primary reports of RCTs published in BioMed Central journals from 2000 to 16 July 2014, subdivided into those with medical writing support (n=110) and those without medical writing support (n=123). Proportion of items that were completely reported from a predefined subset of the Consolidated Standards of Reporting Trials (CONSORT) checklist (12 items known to be commonly poorly reported), overall acceptance time (from manuscript submission to editorial acceptance) and quality of written English as assessed by peer reviewers. The effect of funding source and publication year was examined. The number of articles that completely reported at least 50% of the CONSORT items assessed was higher for those with declared medical writing support (39.1% (43/110 articles); 95% CI 29.9% to 48.9%) than for those without (21.1% (26/123 articles); 95% CI 14.3% to 29.4%). Articles with declared medical writing support were more likely than articles without such support to have acceptable written English (81.1% (43/53 articles); 95% CI 67.6% to 90.1% vs 47.9% (23/48 articles); 95% CI 33.5% to 62.7%). The median time of overall acceptance was longer for articles with declared medical writing support than for those without (167 days (IQR 114.5-231 days) vs 136 days (IQR 77-193 days)). In this sample of open-access journals, declared professional medical writing support was associated with more complete reporting of clinical trial results and higher quality of written English. Medical writing support may play an important role in raising the quality of clinical trial reporting. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go

Supported employment and education in comprehensive, integrated care for first episode psychosis: Effects on work, school, and disability income.

Science.gov (United States)

Rosenheck, Robert; Mueser, Kim T; Sint, Kyaw; Lin, Haiqun; Lynde, David W; Glynn, Shirley M; Robinson, Delbert G; Schooler, Nina R; Marcy, Patricia; Mohamed, Somaia; Kane, John M

2017-04-01

Participation in work and school are central objectives for first episode psychosis (FEP) programs, but evidence effectiveness has been mixed in studies not focused exclusively on supported employment and education (SEE). Requirements for current motivation to work or go to school limit the generalizability of such studies. FEP participants (N=404) at thirty-four community treatment clinics participated in a cluster randomized trial that compared usual Community Care (CC) to NAVIGATE, a comprehensive, team-based treatment program that included ≥5h of SEE services per week, , grounded in many of the principles of the Individual Placement and Support model of supported employment combined with supported education services. All study participants were offered SEE regardless of their initial interest in work or school. Monthly assessments over 24months recorded days of employment and attendance at school, days of participation in SEE, and both employment and public support income (including disability income). General Estimation Equation models were used to compare CC and NAVIGATE on work and school participation, employment and public support income, and the mediating effect of receiving ≥3 SEE visits on these outcomes. NAVIGATE treatment was associated with a greater increase in participation in work or school (p=0.0486) and this difference appeared to be mediated by SEE. No group differences were observed in earnings or public support payments. A comprehensive, team-based FEP treatment approach was associated with greater improvement in work or school participation, and this effect appears to be mediated, in part, by participation in SEE. Published by Elsevier B.V.

The relationship of women's postpartum mental health to employment, childbirth, and social support.

Science.gov (United States)

Gjerdingen, D K; Chaloner, K M

1994-05-01

This study was conducted to examine changes in women's mental health over the first postpartum year and factors that are associated with mental health. Participants included women who were married, employed, English-speaking, and giving birth to their first child at one of two hospitals in St Paul, Minnesota. Women who were eligible and willing to participate were mailed questionnaires at 1, 3, 6, 9, and 12 months postpartum. There were significant changes in mothers' general mental health, depression, and anxiety over the first postpartum year (P appearance, and infant illnesses. In addition, postpartum symptoms were predicted by physical illness, previous mental problems, poor general health, poor social support, fewer recreational activities, young age, and low income (R2 = 37% to 57%). In this select group of women, postpartum mental health was found to be least favorable 1 month after delivery and related to factors associated with employment, recent delivery, and level of social support.

Final Report: Evaluation of Tools and Metrics to Support Employer Selection of Health Plans.

Science.gov (United States)

Mattke, Soeren; Van Busum, Kristin R; Martsolf, Grant R

2014-01-01

The Patient Protection and Affordable Care Act (ACA) places strong emphasis on quality of care as a means to improve outcomes for Americans and promote the financial sustainability of our health care system. Included in the ACA are new disclosure requirements that require health plans to provide a summary of benefits and coverage that accurately describes the benefits under the plan or coverage. These requirements are intended to support employers' procurement of high-value health coverage for their employees. This study attempts to help employers understand the structural differences between health plans and the performance dimensions along which plans can differ, as well as to educate employers about available tools that can be used to evaluate plan options. The study also discusses the extent to which these and other tools or resources are used by employers to inform choices between health plans.

[A group cognitive behavioral intervention for people registered in supported employment programs: CBT-SE].

Science.gov (United States)

Lecomte, T; Corbière, M; Lysaker, P H

2014-06-01

Supported employment programs are highly effective in helping people with severe mental illness obtain competitive jobs quickly. However, job tenure is often a problem for many. Of the various obstacles to job tenure documented, dysfunctional beliefs regarding the workplace and one's own abilities has been proposed as a therapeutic target. The purpose of this article is threefold: (1) to describe the development and the content of a novel group cognitive behavioral intervention designed to increase job tenure for people receiving supported employment services; (2) to present the feasibility and acceptability of the intervention; and (3) to investigate some preliminary data regarding employment outcomes. A group CBT intervention offered during 8 sessions over the course of one month, in order to respect the rapid job search principle of IPS (individual placement and support), was developed. The content was tailored to facilitate the learning of skills specific to the workplace, such as recognizing and managing one's stressors at work, determining and modifying dysfunctional thoughts (e.g. not jumping to conclusions, finding alternatives, seeking facts), overcoming obstacles (e.g. problem solving), improving one's self-esteem as a worker (recognizing strengths and qualities), dealing with criticism, using positive assertiveness, finding coping strategies (for symptoms and stress) to use at work, negotiating work accommodations and overcoming stigma. A trial is currently underway, with half the participants receiving supported employment as well as CBT-SE and the other half receiving only supported employment. A subsample of the first 24 participants having completed the 12-month follow-up were used for the analyses, including 12 having received at least 3 sessions out of the 8 group sessions and 12 receiving only supported employment. Feasibility and acceptability were determined by the group therapists' feedback, the participants' feedback as well as attendance to

Gender Employment Longevity: I.T Staff Response to Organizational Support in Pakistan

OpenAIRE

Haque, Adnan ul; Yamoah, Fred

2014-01-01

This research attempts to explain reasons behind employment longevity on the basis of gender among the I.T staff. Previous empirical researches have confirmed the correlation between organisational commitment, job satisfaction, and organisational support programme. However, most researches were single dimension primarily due to their focus on establishing the relationship between above mentioned variables in different organisational settings whereas, this research mainly explore on the groun...

Supported Employment for Veterans With Traumatic Brain Injury: Patient Perspectives.

Science.gov (United States)

Carlson, Kathleen F; Pogoda, Terri K; Gilbert, Tess A; Resnick, Sandra G; Twamley, Elizabeth W; O'Neil, Maya E; Sayer, Nina A

2018-02-01

To quantify the need for, and interest in, supported employment (SE) among recent military veterans with traumatic brain injury (TBI); and to examine characteristics associated with veterans' interest in SE. Stratified random sample of Iraq and Afghanistan War veterans confirmed to have TBI through the Veterans Health Administration (VHA) screening and evaluation system. Community-based via mailed survey. We recruited 1800 veterans with clinician-confirmed TBI (mild TBI: n=1080; moderate/severe TBI: n=720) through multiple mailings. Among 1451 surveys that were not returned undeliverable, N=616 (42%) responded. Not applicable. Veterans rated their interest in SE after reading a script describing the program. Additional measures assessed mental health and pain-related comorbidities, employment, financial/housing difficulties, demographics, and military service characteristics. Estimates were weighted to represent the population of veterans with VHA clinician-confirmed TBI. Unemployment was reported by 45% (95% confidence interval [CI], 43-47) of veterans with TBI. Although 42% (95% CI, 40-44) reported they would be interested in using SE if it were offered to them, only 12% had heard of SE (95% CI, 11-14) and interest in SE. However, those who were unemployed, looking for work, experiencing financial strain, or at risk for homelessness were more likely to be interested in SE. Our research highlights an important gap between veterans' vocational needs and interests and their use of SE. Systematically identifying and referring those with employment and financial/housing difficulties may help close this gap. Published by Elsevier Inc.

A decision aid to assist decisions on disclosure of mental health status to an employer: protocol for the CORAL exploratory randomised controlled trial

Directory of Open Access Journals (Sweden)

Henderson Claire

2012-08-01

Full Text Available Abstract Background The UK Equality Act 2010 makes it unlawful for employers to ask health questions before making an offer of employment except in certain circumstances. While the majority of employers would prefer applicants to disclose a mental illness at the application stage, many people either wait until they have accepted the job and then disclose to an occupational health professional, or do not do so at all due to the anticipation of discrimination or a wish for privacy. However, non disclosure precludes the ability to request reasonable adjustments in the workplace or to make a claim of direct discrimination. Disclosure to employers is therefore a difficult decision. A recent pilot study by our group of the CORAL decision aid showed that it helped mental health service users clarify their needs and values regarding disclosure and led to reduction in decisional conflict. The present proof of concept trial aims to determine whether a full scale randomised controlled trial (RCT is justifiable and feasible, and to optimise its design. Methods In this single blind exploratory RCT in London, a total of 80 participants (inclusion criteria: age ≥18 years, on the caseload of a specialist employment adviser working with people with mental illness; referred to the adviser either from primary care via Improving Access to Psychological Therapies or secondary mental health service; currently seeking or interested in either paid or voluntary employment, and a Decisional Conflict Scale score of 37.5 or greater and stage of decision score 1–5 will be recruited from vocational advice services. After completing a baseline assessment, participants will be randomly assigned to one of two conditions (1 Use of the CORAL Decision Aid (DA in addition to treatment as usual or (2 Treatment as usual. Those allocated to the DA condition will be given it to read and complete, and the researcher will be present to record the time taken and any content that

Feasibility of personalised remote long-term follow-up of people with cochlear implants: a randomised controlled trial.

Science.gov (United States)

Cullington, Helen; Kitterick, Padraig; Weal, Mark; Margol-Gromada, Magdalena

2018-04-20

Substantial resources are required to provide lifelong postoperative care to people with cochlear implants. Most patients visit the clinic annually. We introduced a person-centred remote follow-up pathway, giving patients telemedicine tools to use at home so they would only visit the centre when intervention was required. To assess the feasibility of comparing a remote care pathway with the standard pathway in adults using cochlear implants. Two-arm randomised controlled trial. Randomisation used a minimisation approach, controlling for potential confounding factors. Participant blinding was not possible, but baseline measures occurred before allocation. University of Southampton Auditory Implant Service: provider of National Health Service care. 60 adults who had used cochlear implants for at least 6 months. Control group (n=30) followed usual care pathway.Remote care group (n=30) received care remotely for 6 months incorporating: home hearing in noise test, online support tool and self-adjustment of device (only 10 had compatible equipment). Primary: change in patient activation; measured using the Patient Activation Measure.Secondary: change in hearing and quality of life; qualitative feedback from patients and clinicians. One participant in the remote care group dropped out. The remote care group showed a greater increase in patient activation than the control group. Changes in hearing differed between the groups. The remote care group improved on the Triple Digit Test hearing test; the control group perceived their hearing was worse on the Speech, Spatial and Qualities of Hearing Scale questionnaire. Quality of life remained unchanged in both groups. Patients and clinicians were generally positive about remote care tools and wanted to continue. Adults with cochlear implants were willing to be randomised and complied with the protocol. Personalised remote care for long-term follow-up is feasible and acceptable, leading to more empowered patients. ISRCTN14644286

Workplace lactation support by New Jersey employers following US Reasonable Break Time for Nursing Mothers law.

Science.gov (United States)

Bai, Yeon K; Gaits, Susan I; Wunderlich, Shahla M

2015-02-01

Returning to an unsupportive work environment has been identified as a major reason for avoidance or early abandonment of breastfeeding among working mothers. This study aimed to examine the nature and extent of accommodations offered to breastfeeding employees among New Jersey employers since the US federal Reasonable Break Time for Nursing Mothers law enactment. A cross-sectional survey was conducted to measure current lactation support in the workplace in New Jersey. Using convenience sampling, the survey was sent to managerial personnel in hospitals and nonhospitals. The level of support was assessed on company policy, lactation room, and room amenity. A composite lactation amenity score was calculated based on responses about lactation room amenities. Respondents (N = 51) completed a 22-item online questionnaire during fall 2011. The support level was compared by type of organization: hospital (n = 37) versus nonhospital (n = 14). The amenity score of hospitals was significantly higher than nonhospitals (1.44 vs 0.45, P = .002). The mean amenity score (score = 0.95) for all employers was far below comprehensive (score = 3.0). Compared to nonhospitals, hospitals were more likely to offer lactation rooms (81% vs 36%, P = .003), have their own breastfeeding policy (35.1% vs 7.1%, P = .01), and provide additional breastfeeding support (eg, education classes, resources; P < .05). Employers, regardless of the type of organization, need to improve their current practices and create equity of lactation support in the workplace. © The Author(s) 2014.

Social support and the working hours of employed mothers in Europe: The relevance of the state, the workplace, and the family.

Science.gov (United States)

Abendroth, Anja-Kristin; van der Lippe, Tanja; Maas, Ineke

2012-05-01

This paper studies the influence of state, workplace, and family support on the working hours of employed mothers and how these different support sources interact. Data taken from the European Social Survey 2004/2005 as well as country-specific information were used to estimate several hierarchical models. We find evidence that the availability of supportive workplace arrangements and family support positively impact the working hours of employed mothers and that state policies facilitating the traditional family have a negative effect. There is weak support for a positive relationship between state policies facilitating the dual-earner family and working hours of employed mothers. In addition, most of the sources of support appear to be complementary. Supportive family role models and supportive workplace arrangements have a reinforcing relationship, as do publicly funded child care and supportive workplace arrangements. Copyright © 2012 Elsevier Inc. All rights reserved.

The meaning and experience of stress among supported employment clients with mental health problems.

Science.gov (United States)

Besse, Christine; Poremski, Daniel; Laliberté, Vincent; Latimer, Eric

2018-05-01

Many clinicians are concerned that competitive work may cause excessive stress for people with severe mental health problems. Individual Placement and Support (IPS) is acknowledged as the most effective model of supported employment for this population. The manner in which IPS clients define and experience employment-related stress is poorly understood. This qualitative study aims to explore how people with mental health problems receiving IPS services define and experience employment-related stress. We purposively sampled and interviewed 16 clients of an IPS programme, who had been competitively employed for more than 1 month. Data were collected between September 2014 and July 2015 in Montreal, Canada. Transcripts of semi-structured interviews were analysed using grounded theory methodology. IPS clients often defined stress similar to its common understanding: the result of experiencing prolonged or/and cumulative strains, or of an incongruence between efforts and rewards, hopes and reality. Stress experienced in this way could exacerbate psychiatric symptoms, especially depression or psychotic symptoms. However, when maintained at a more manageable level, stress stimulated learning and improved planning of tasks. Participants described different coping mechanisms, such as sharing their experiences and difficulties with others, focusing on problem resolution and avoidance. The first two of these helped IPS clients remain at work and bolstered their confidence. Work-related stress has potentially positive as well as negative consequences for IPS clients. In order to maximise the potential beneficial effects of stress, employment specialists can help clients anticipate potential stressors and plan how they might cope with them. Further research on the most effective ways of helping clients cope with stress is needed. © 2017 John Wiley & Sons Ltd.

Breastfeeding works: the role of employers in supporting women who wish to breastfeed and work in four organizations in England.

Science.gov (United States)

Kosmala-Anderson, Joanna; Wallace, Louise M

2006-09-01

An important factor influencing duration of breastfeeding is mother's employment status. The main aim of this study was to determine the experience and views of employees (n = 46) in four large public sector organizations concerning breastfeeding support at work. Participants were recruited if they were employed by one of four public service employers and if they were planning to go on maternity leave in the next 6 months, on maternity leave or within 6 months of return from maternity leave. They completed a questionnaire anonymously. Almost 80% of women wanted to continue breastfeeding after returning to work. However, 90% of all respondents were not aware of any employer policy nor offered any information concerning support to enable breastfeeding after returning to work, despite two organizations having a range of maternity- and breastfeeding-related policies in development and some facilities in place. Almost 90% of respondents stated the employers should do more to support breastfeeding. This should include providing pregnant staff with information about breastfeeding support that they should expect and could therefore plan to use, including access to facilities to express and to store breast milk, to enable them to work flexible hours and to take rest breaks during working hours. Recommendations are made for employers.

Relationship between obesity and the risk of clinically significant depression: Mendelian randomisation study.

LENUS (Irish Health Repository)

Hung, Chi-Fa

2014-07-01

Obesity has been shown to be associated with depression and it has been suggested that higher body mass index (BMI) increases the risk of depression and other common mental disorders. However, the causal relationship remains unclear and Mendelian randomisation, a form of instrumental variable analysis, has recently been employed to attempt to resolve this issue.

Cross-Age Mentoring to Support A-Level Pupils' Transition into Higher Education and Undergraduate Students' Employability

Science.gov (United States)

James, Alana I.

2014-01-01

Two challenges identified for psychology higher education are supporting entry students' transition, and supporting graduates' transition into employment. The evaluation of the first phase of a cross-age mentoring action research project targeting these issues is presented; eight psychology undergraduates mentored 20 A-level psychology pupils in…

Randomised controlled trials in Scandinavian educational research

DEFF Research Database (Denmark)

Pontoppidan, Maiken; Keilow, Maria; Dietrichson, Jens

2018-01-01

of this paper is to examine the history of randomised controlled trials in Scandinavian compulsory schools (grades 0–10; pupil ages 6-15). Specifically, we investigate drivers and barriers for randomised controlled trials in educational research and the differences between the three Scandinavian countries...... crucial for the implementation of RCTs and are likely more important in smaller countries such as the Scandinavian ones. Supporting institutions have now been established in all three countries, and we believe that the use of RCTs in Scandinavian educational research is likely to continue....... or more interventions were randomly assigned to groups of students and carried out in a school setting with the primary aim of improving the academic performance of children aged 6-15 in grades 0–10 in Denmark, Norway, or Sweden. We included both conducted and ongoing trials. Publications that seemed...

Effect on return to work or education of individual placement and support modified for people with mood and anxiety disorders

DEFF Research Database (Denmark)

Hellström, Lone; Bech, Per; Hjorthøj, Carsten

2017-01-01

disorders (IPS-MA) on return to work and education compared with services as usual (SAU). Methods: In a randomised clinical superiority trial, 326 participants with mood and anxiety disorders were centrally randomised to IPS-MA, consisting of individual mentor support and career counselling (n=162) or SAU......Objectives: The effect of Individual Placement and Support (IPS) on return to work or education among people with mood or anxiety disorders is unclear, while IPS increases return to work for people with severe mental illness. We examined the effect of IPS modified for people with mood and anxiety...... returned to work or education compared with 37.8% (62/164) following SAU (OR=1.34, 95% CI: 0.86 to 2.10, p=0.20). We found no difference in mean number of weeks in employment or education (IPS-MA 32.4 weeks vs SAU 26.7 weeks, p=0.14), level of depression (Hamilton Depression 6-Item Scale score IPS-MA 5...

PRISM (Program of Resources, Information and Support for Mothers Protocol for a community-randomised trial [ISRCTN03464021

Directory of Open Access Journals (Sweden)

Gunn Jane

2003-11-01

Full Text Available Abstract Background In the year after birth one in six women has a depressive illness, and 30% are still depressed, or depressed again, when their child is 2 years old, 94% experience at least one major health problem (e.g. back pain, perineal pain, mastitis, urinary or faecal incontinence, 26% experience sexual problems and almost 20% have relationship problems with partners. Women with depression report less practical and emotional support from partners, less social support overall, more negative life events, and poorer physical health. Their perceptions of factors contributing to depression are lack of support, isolation, exhaustion and physical health problems. Fewer than one in three affected women seek help in primary care despite frequent contacts. Methods/Design PRISM aims to reduce depression and physical health problems of recent mothers through primary care strategies to increase practitioners' response to these issues, and through community-based strategies to develop broader family and community supports for recent mothers. Eligible local governments will be recruited and randomised to intervention or comparison arms, after stratification (urban/rural, size, birth numbers, extent of community activity, avoiding contiguous boundaries. Maternal depression and physical health will be measured six months after birth, in a one year cohort of mothers, in intervention and comparison communities. The sample size to detect a 20% relative reduction in depression, adjusting for cluster sampling, and estimating a population response fraction of 67% is 5740 × 2. Analysis of the physical and mental health outcomes, by intention to treat, will adjust for the correlated structure of the data.

Bridging the age gap in breast cancer: evaluation of decision support interventions for older women with operable breast cancer: protocol for a cluster randomised controlled trial.

Science.gov (United States)

Collins, Karen; Reed, Malcolm; Lifford, Kate; Burton, Maria; Edwards, Adrian; Ring, Alistair; Brain, Katherine; Harder, Helena; Robinson, Thompson; Cheung, Kwok Leung; Morgan, Jenna; Audisio, Riccardo; Ward, Susan; Richards, Paul; Martin, Charlene; Chater, Tim; Pemberton, Kirsty; Nettleship, Anthony; Murray, Christopher; Walters, Stephen; Bortolami, Oscar; Armitage, Fiona; Leonard, Robert; Gath, Jacqui; Revell, Deirdre; Green, Tracy; Wyld, Lynda

2017-07-31

While breast cancer outcomes are improving steadily in younger women due to advances in screening and improved therapies, there has been little change in outcomes among the older age group. It is inevitable that comorbidities/frailty rates are higher, which may increase the risks of some breast cancer treatments such as surgery and chemotherapy, many older women are healthy and may benefit from their use. Adjusting treatment regimens appropriately for age/comorbidity/frailty is variable and largely non-evidence based, specifically with regard to rates of surgery for operable oestrogen receptor-positive disease and rates of chemotherapy for high-risk disease. This multicentre, parallel group, pragmatic cluster randomised controlled trial (RCT) (2015-18) reported here is nested within a larger ongoing 'Age Gap Cohort Study' (2012-18RP-PG-1209-10071), aims to evaluate the effectiveness of a complex intervention of decision support interventions to assist in the treatment decision making for early breast cancer in older women. The interventions include two patient decision aids (primary endocrine therapy vs surgery/antioestrogen therapy and chemotherapy vs no chemotherapy) and a clinical treatment outcomes algorithm for clinicians. National and local ethics committee approval was obtained for all UK participating sites. Results from the trial will be submitted for publication in international peer-reviewed scientific journals. 115550. European Union Drug Regulating Authorities Clinical Trials (EudraCT) number 2015-004220-61;Pre-results. Sponsor's Protocol Code Number Sheffield Teaching Hospitals STH17086. ISRCTN 32447*. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Social firms: building cross-sectoral partnerships to create employment opportunity and supportive workplaces for people with mental illness.

Science.gov (United States)

Paluch, Tamar; Fossey, Ellie; Harvey, Carol

2012-01-01

A major barrier to employment for people with mental illness is limited access to supportive and non-discriminatory workplaces. Social firms are businesses committed to employing up to 50% of people with a disability or other disadvantage and to providing supportive work environments that benefit workers. Little research has been conducted to understand the features and social processes that support the vocational experiences of employees with mental health issues in social firms. This ethnographic study sought to explore the experiences of nine employees at one Australian social firm. Nine employees of a social firm, with and without mental illness. Study methods used included participant observation, interviewing and document analysis. The study highlights the complexity of running a socially-invested business, and the importance of cross-sectoral partnerships to support their operational success. Natural workplace supports, adequate training and support infrastructure and enabling participation in the business, were identified as important to creating a supportive workplace. Partnerships within the workplace and in support of the workplace are discussed. Future growth and development of partnerships are recommended to support the establishment of social firms.

Development of the Supported Employment, Comprehensive Cognitive Enhancement, and Social Skills program for adults on the autism spectrum: Results of initial study.

Science.gov (United States)

Baker-Ericzén, Mary J; Fitch, Meghan A; Kinnear, Mikaela; Jenkins, Melissa M; Twamley, Elizabeth W; Smith, Linda; Montano, Gabriel; Feder, Joshua; Crooke, Pamela J; Winner, Michelle G; Leon, Juan

2018-01-01

The population of adults on the autism spectrum continues to increase, and vocational outcomes are particularly poor. Longitudinal studies of adults with autism spectrum and without intellectual disability have shown consistent and persistent deficits across cognitive, social, and vocational domains, indicating a need for effective treatments of functional disabilities as each impact employment. This initial pilot study is an open trial investigation of the feasibility, acceptability, and initial estimates of outcomes for the newly developed Supported Employment, Comprehensive Cognitive Enhancement, and Social Skills intervention, a manualized "soft skills" curriculum, to enhance both cognitive and social development in adults with autism spectrum. A total of eight adults with autism spectrum, without intellectual disability (78% males), participated in the study. Results support the original hypothesis that adults with autism spectrum can improve both cognitive (i.e. executive functioning) and social cognitive (i.e. social thinking and social communication) abilities. Further Supported Employment, Comprehensive Cognitive Enhancement, and Social Skills was found to be feasible, acceptable, and highly satisfactory for participants and parents. Employment rates more than doubled post-intervention, with an increase from 22% to 56% of participants employed. Conclusion is that Supported Employment, Comprehensive Cognitive Enhancement, and Social Skills has promise as an intervention that can be easily embedded into exiting supported employment vocational training programs to improve cognitive, social, and vocational outcomes.

The Tulip GT® airway versus the facemask and Guedel airway: a randomised, controlled, cross-over study by Basic Life Support-trained airway providers in anaesthetised patients.

Science.gov (United States)

Shaikh, A; Robinson, P N; Hasan, M

2016-03-01

We performed a randomised, controlled, cross-over study of lung ventilation by Basic Life Support-trained providers using either the Tulip GT® airway or a facemask with a Guedel airway in 60 anaesthetised patients. Successful ventilation was achieved if the provider produced an end-tidal CO2 > 3.5 kPa and a tidal volume > 250 ml in two of the first three breaths, within 60 sec and within two attempts. Fifty-seven (95%) providers achieved successful ventilation using the Tulip GT compared with 35 (58%) using the facemask (p Basic Life Support-trained airway providers. © 2015 The Association of Anaesthetists of Great Britain and Ireland.

Joining the Dots: Theoretically Connecting the Vona du Toit Model of Creative Ability (VdTMoCA) with Supported Employment

OpenAIRE

de Bruyn, Marna; Wright, Jon

2017-01-01

The Vona du Toit Model of Creative Ability (VdTMoCA) presents a framework for understanding client motivation and action in occupational therapy, emphasising the relationship between motivation and action. Similarly, motivation to work is regarded as the primary and in some instances, the only eligibility criterion for inclusion in supported employment services. This commentary explores the potential theoretical link between the VdTMoCA and supported employment, primarily applied to the South...

Supporting workers with mental health problems to retain employment: users' experiences of a UK job retention project.

Science.gov (United States)

Cameron, Josh; Walker, Carl; Hart, Angie; Sadlo, Gaynor; Haslam, Imogen; Retain Support Group

2012-01-01

To understand experiences and perspectives of job retention project users in relation to challenges faced and support received; to develop explanatory insight into effective interventions. 14 employed users of a United Kingdom job retention project, with a range of mental health problems. Semi-structured individual interviews which were collaboratively designed with service users. Data analysis involved deductive & inductive thematic analysis, constant comparative analysis, and service user collaboration. Participants' feelings of guilt and self blame were a major obstacle to job retention. The project helped them address these by supporting a reappraisal of their situation. This assisted identification of job accommodations and adjustments and confidence in self advocacy. Thus an important basis for improved dialogue with their employer was established. A peer support group provided an important adjunct to individual project worker interventions. 10 participants retained employment; three of those who did not were helped to retain work aspirations. The project effectively used a multi-faceted approach involving a person - environment-occupation focus on the worker, their work, and workplace. Such complex interventions may offer more promise than those interventions (such as cognitive behavioural therapy) which have a primary focus on the individual worker.

INSPIRE (INvestigating Social and PractIcal suppoRts at the End of life): Pilot randomised trial of a community social and practical support intervention for adults with life-limiting illness.

LENUS (Irish Health Repository)

McLoughlin, Kathleen

2015-11-24

For most people, home is the preferred place of care and death. Despite the development of specialist palliative care and primary care models of community based service delivery, people who are dying, and their families\\/carers, can experience isolation, feel excluded from social circles and distanced from their communities. Loneliness and social isolation can have a detrimental impact on both health and quality of life. Internationally, models of social and practical support at the end of life are gaining momentum as a result of the Compassionate Communities movement. These models have not yet been subjected to rigorous evaluation. The aims of the study described in this protocol are: (1) to evaluate the feasibility, acceptability and potential effectiveness of The Good Neighbour Partnership (GNP), a new volunteer-led model of social and practical care\\/support for community dwelling adults in Ireland who are living with advanced life-limiting illness; and (2) to pilot the method for a Phase III Randomised Controlled Trial (RCT).

Farmers as Employers. Level 1. Level 2. Level 3. Support Materials for Agricultural Training.

Science.gov (United States)

Batman, Kangan; Gadd, Nick; Lucas, Michele

This publication contains the three communication skills units of the three levels of Support Materials for Agricultural Training (SMAT) in the area of farmers as employers: Level 1 (starting), 2 (continuing), and 3 (completing). The units are designed to help the learner improve his or her written and spoken communication and numeracy skills…

Employment for adults with autism spectrum disorders: A retrospective review of a customized employment approach.

Science.gov (United States)

Wehman, Paul; Brooke, Valerie; Brooke, Alissa Molinelli; Ham, Whitney; Schall, Carol; McDonough, Jennifer; Lau, Stephanie; Seward, Hannah; Avellone, Lauren

2016-01-01

Over the past few decades, there has been an increase in prevalence of children with autism spectrum disorders (ASD), and those children are now becoming young adults in need of competitive integrated employment (CIE). Customized employment (CE) is one pathway to employment that has been successful for other individuals with developmental disabilities (DD), though research has been very limited on the effectiveness with individuals with ASD. This paper provides a retrospective review of 64 individuals with ASD who came to our program from 2009 to 2014 for supported employment services as referred by the state vocational rehabilitation services agency. Employment specialists engaged in situational assessment, discovery, job development, customized job descriptions, on-site training and support, positive behavioral supports, and job retention techniques. The employment specialists were responsible for tracking their actual time spent working directly with or for the jobseeker with autism spectrum disorders (ASD). All vocational rehabilitation clients with ASD served during this time successfully secured CIE, and maintained their employment with ongoing supports, with intensity of support time decreasing over time. The majority (63/64, 98.4%) of individuals successfully secured CIE through the use of supported employment, in 72 unique employment positions. Of the majority of the individuals who secured employment, 77% (50) individuals indicated that they had never worked before and additional 18% (12) reported having short intermittent histories of employment. Despite this lack of employment experience, in all cases the jobseeker directed the job search and ultimately the job selection. Copyright © 2016 Elsevier Ltd. All rights reserved.

The effect of a supportive educational intervention developed based on the Orem's self-care theory on the self-care ability of patients with myocardial infarction: a randomised controlled trial.

Science.gov (United States)

Mohammadpour, Ali; Rahmati Sharghi, Narjes; Khosravan, Shahla; Alami, Ali; Akhond, Majid

2015-06-01

The aim of this study was to assess the effect of a supportive educational intervention developed based on the Orem's self-care theory on the self-care ability of patients with myocardial infarction. Patients with cardiovascular disease suffer from the lack of knowledge about the disease and consequently are not able to fulfil their own self-care needs. This was a randomised controlled trial conducted in 2012. We recruited a random sample of 66 patients with myocardial infarction who had been recently discharged from coronary care unit. The study setting was two university hospitals located in Khorasan, Iran. Patients were randomly allocated to either the experimental or the control groups. Patients in the experimental group received education, support, and counselling while patients in the control group received no intervention. We employed a demographic questionnaire and the Myocardial Infarction Self-Care Ability Questionnaire for data collection and spss version 16.00 for data analysis. After the study, patients in the experimental group had higher levels of self-care knowledge, motivation and skills compared to the prestudy readings and the control group. The supportive educational intervention developed based on the Orem's self-care theory can improve nonhospitalised patients' self-care ability and positively affect public health outcomes. Consequently, using the developed programme for providing follow-up care to nonhospitalised patients is recommended. Having the ability to develop caring systems based on the nursing theories is a prerequisite to standard nursing practice. Identifying patients' educational needs is a fundamental prerequisite to patient education. Our findings revealed that the supportive educational intervention developed based on the Orem's self-care theory can help health care providers identify and fulfil patients' self-care needs. © 2015 John Wiley & Sons Ltd.

Gym-based exercise was more costly compared with home-based exercise with telephone support when used as maintenance programs for adults with chronic health conditions: cost-effectiveness analysis of a randomised trial

Directory of Open Access Journals (Sweden)

Paul Jansons

2018-01-01

Registration: ACTRN12610001035011. [Jansons P, Robins L, O’Brien L, Haines T (2018 Gym-based exercise was more costly compared with home-based exercise with telephone support when used as maintenance programs for adults with chronic health conditions: cost-effectiveness analysis of a randomised trial. Journal of Physiotherapy 64: 48–54

Study protocol: the effectiveness and cost effectiveness of an employer-led intervention to increase walking during the daily commute: the Travel to Work randomised controlled trial.

Science.gov (United States)

Audrey, Suzanne; Cooper, Ashley R; Hollingworth, William; Metcalfe, Chris; Procter, Sunita; Davis, Adrian; Campbell, Rona; Gillison, Fiona; Rodgers, Sarah E

2015-02-18

Physical inactivity increases the risk of many chronic diseases including coronary heart disease, type 2 diabetes and some cancers. It is recommended that adults should undertake at least 150 minutes of moderate intensity physical activity throughout the week but many adults do not achieve this. An opportunity for working adults to accumulate the recommended activity levels is through the daily commute. Employees will be recruited from workplaces in south-west England and south Wales. In the intervention arm, workplace Walk-to-Work promoters will be recruited and trained. Participating employees will receive Walk-to-Work materials and support will be provided through four contacts from the promoters over 10 weeks. Workplaces in the control arm will continue with their usual practice. The intervention will be evaluated by a cluster randomized controlled trial including economic and process evaluations. The primary outcome is daily minutes of moderate to vigorous physical activity (MVPA). Secondary outcomes are: overall physical activity; sedentary time; modal shift away from private car use during the commute; and physical activity/MVPA during the commute. Accelerometers, GPS receivers and travel diaries will be used at baseline and one year follow-up. Questionnaires will be used at baseline, immediately post intervention, and one year follow-up. The process evaluation will examine the context, delivery and response to the intervention from the perspectives of employers, Walk-to-Work promoters and employees using questionnaires, descriptive statistics, fieldnotes and interviews. A cost-consequence study will include employer, employee and health service costs and outcomes. Time and consumables used in implementing the intervention will be measured. Journey time, household commuting costs and expenses will be recorded using travel diaries to estimate costs to employees. Presenteeism, absenteeism, employee wellbeing and health service use will be recorded. Compared

INSPIRE (INvestigating Social and PractIcal suppoRts at the End of life): Pilot randomised trial of a community social and practical support intervention for adults with life-limiting illness.

Science.gov (United States)

McLoughlin, Kathleen; Rhatigan, Jim; McGilloway, Sinead; Kellehear, Allan; Lucey, Michael; Twomey, Feargal; Conroy, Marian; Herrera-Molina, Emillio; Kumar, Suresh; Furlong, Mairead; Callinan, Joanne; Watson, Max; Currow, David; Bailey, Christopher

2015-11-24

For most people, home is the preferred place of care and death. Despite the development of specialist palliative care and primary care models of community based service delivery, people who are dying, and their families/carers, can experience isolation, feel excluded from social circles and distanced from their communities. Loneliness and social isolation can have a detrimental impact on both health and quality of life. Internationally, models of social and practical support at the end of life are gaining momentum as a result of the Compassionate Communities movement. These models have not yet been subjected to rigorous evaluation. The aims of the study described in this protocol are: (1) to evaluate the feasibility, acceptability and potential effectiveness of The Good Neighbour Partnership (GNP), a new volunteer-led model of social and practical care/support for community dwelling adults in Ireland who are living with advanced life-limiting illness; and (2) to pilot the method for a Phase III Randomised Controlled Trial (RCT). The INSPIRE study will be conducted within the Medical Research Council (MRC) Framework for the Evaluation of Complex Interventions (Phases 0-2) and includes an exploratory two-arm delayed intervention randomised controlled trial. Eighty patients and/or their carers will be randomly allocated to one of two groups: (I) Intervention: GNP in addition to standard care or (II) Control: Standard Care. Recipients of the GNP will be asked for their views on participating in both the study and the intervention. Quantitative and qualitative data will be gathered from both groups over eight weeks through face-to-face interviews which will be conducted before, during and after the intervention. The primary outcome is the effect of the intervention on social and practical need. Secondary outcomes are quality of life, loneliness, social support, social capital, unscheduled health service utilisation, caregiver burden, adverse impacts, and satisfaction

Supported Decision-Making: Implications from Positive Psychology for Assessment and Intervention in Rehabilitation and Employment.

Science.gov (United States)

Uyanik, Hatice; Shogren, Karrie A; Blanck, Peter

2017-12-01

Purpose This article reviews existing literature on positive psychology, supported decision-making (SDM), employment, and disability. It examines interventions and assessments that have been empirically evaluated for the enhancement of decision-making and overall well-being of people with disabilities. Additionally, conceptual themes present in the literature were explored. Methods A systematic review was conducted across two databases (ERIC and PsychINFO) using various combination of keywords of 'disabilit*', work rehabilitation and employment terms, positive psychology terms, and SDM components. Seven database searches were conducted with diverse combinations of keywords, which identified 1425 results in total to be screened for relevance using their titles and abstracts. Database search was supplemented with hand searches of oft-cited journals, ancestral search, and supplemental search from grey literature. Results Only four studies were identified in the literature targeting SDM and positive psychology related constructs in the employment and job development context. Results across the studies indicated small to moderate impacts of the assessment and interventions on decision-making and engagement outcomes. Conceptually there are thematic areas of potential overlap, although they are limited in the explicit integration of theory in supported decision-making, positive psychology, disability, and employment. Conclusion Results suggest a need for additional scholarship in this area that focuses on theory development and integration as well as empirical work. Such work should examine the potential utility of considering positive psychological interventions when planning for SDM in the context of career development activities to enhance positive outcomes related to decision-making, self-determination, and other positive psychological constructs.

The ANU WellBeing study: a protocol for a quasi-factorial randomised controlled trial of the effectiveness of an Internet support group and an automated Internet intervention for depression

Directory of Open Access Journals (Sweden)

Mackinnon Andrew J

2010-03-01

Full Text Available Abstract Background Recent projections suggest that by the year 2030 depression will be the primary cause of disease burden among developed countries. Delivery of accessible consumer-focused evidenced-based services may be an important element in reducing this burden. Many consumers report a preference for self-help modes of delivery. The Internet offers a promising modality for delivering such services and there is now evidence that automated professionally developed self-help psychological interventions can be effective. By contrast, despite their popularity, there is little evidence as to the effectiveness of Internet support groups which provide peer-to-peer mutual support. Methods/Design Members of the community with elevated psychological distress were randomised to receive one of the following: (1 Internet Support Group (ISG intervention, (2 a multi-module automated psychoeducational and skills Internet Training Program (ITP, (3 a combination of the ISG and ITP, or (4 an Internet Attention Control website (IAC comprising health and wellbeing information and question and answer modules. Each intervention was 12 weeks long. Assessments were conducted at baseline, post-intervention, 6 and 12 months to examine depressive symptoms, social support, self-esteem, quality of life, depression literacy, stigma and help-seeking for depression. Participants were recruited through a screening postal survey sent to 70,000 Australians aged 18 to 65 years randomly selected from four rural and four metropolitan regions in Australia. Discussion To our knowledge this study is the first randomised controlled trial of the effectiveness of a depression ISG. Trial registration Current Controlled Trials ISRCTN65657330.

A cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary care research: the TRANSFoRm study protocol.

Science.gov (United States)

Mastellos, Nikolaos; Andreasson, Anna; Huckvale, Kit; Larsen, Mark; Curcin, Vasa; Car, Josip; Agreus, Lars; Delaney, Brendan

2015-02-03

Opportunistic recruitment is a highly laborious and time-consuming process that is currently performed manually, increasing the workload of already busy practitioners and resulting in many studies failing to achieve their recruitment targets. The Translational Medicine and Patient Safety in Europe (TRANSFoRm) platform enables automated recruitment, data collection and follow-up of patients, potentially improving the efficiency, time and costs of clinical research. This study aims to assess the effectiveness of TRANSFoRm in improving patient recruitment and follow-up in primary care trials. This multi-centre, parallel-arm cluster randomised controlled trial will compare TRANSFoRm-supported with standard opportunistic recruitment. Participants will be general practitioners and patients with gastro-oesophageal reflux disease from 40 primary care centres in five European countries. Randomisation will take place at the care centre level. The intervention arm will use the TRANSFoRm tools for recruitment, baseline data collection and follow-up. The control arm will use web-based case report forms and paper self-completed questionnaires. The primary outcome will be the proportion of eligible patients successfully recruited at the end of the 16-week recruitment period. Secondary outcomes will include the proportion of recruited patients with complete baseline and follow-up data and the proportion of participants withdrawn or lost to follow-up. The study will also include an economic evaluation and measures of technology acceptance and user experience. The study should shed light on the use of eHealth to improve the effectiveness of recruitment and follow-up in primary care research and provide an evidence base for future eHealth-supported recruitment initiatives. Reporting of results is expected in October 2015. EudraCT: 2014-001314-25.

Risk of bias assessment of randomised controlled trials in high-impact ophthalmology journals and general medical journals: a systematic review.

Science.gov (United States)

Joksimovic, Lazar; Koucheki, Robert; Popovic, Marko; Ahmed, Yusuf; Schlenker, Matthew B; Ahmed, Iqbal Ike K

2017-10-01

Evidence-based treatments in ophthalmology are often based on the results of randomised controlled trials. Biased conclusions from randomised controlled trials may lead to inappropriate management recommendations. This systematic review investigates the prevalence of bias risk in randomised controlled trials published in high-impact ophthalmology journals and ophthalmology trials from general medical journals. Using Ovid MEDLINE, randomised controlled trials in the top 10 high-impact ophthalmology journals in 2015 were systematically identified and critically appraised for the prevalence of bias risk. Included randomised controlled trials were assessed in all domains of bias as defined by the Cochrane Collaboration. In addition, the prevalence of conflict of interest and industry sponsorship was investigated. A comparison with ophthalmology articles from high-impact general medical journals was performed. Of the 259 records that were screened from ophthalmology-specific journals, 119 trials met all inclusion criteria and were critically appraised. In total, 29.4% of domains had an unclear risk, 13.8% had a high risk and 56.8% had a low risk of bias. In comparison, ophthalmology articles from general medical journals had a lower prevalence of unclear risk (17.1%), higher prevalence of high risk (21.9%) and a higher prevalence of low risk domains (61.9%). Furthermore, 64.7% of critically appraised trials from ophthalmology-specific journals did not report any conflicts of interest, while 70.6% did not report an industry sponsor of their trial. In closing, it is essential that authors, peer reviewers and readers closely follow published risk of bias guidelines. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Cross-age mentoring to support A-level pupils’ transition into Higher Education and undergraduate students’ employability

OpenAIRE

James, Alana I.

2014-01-01

Two challenges identified for psychology higher education are supporting entry students’ transition, and supporting graduates’ transition into employment. The evaluation of the first phase of a cross-age mentoring action research project targeting these issues is presented; eight psychology undergraduates mentored 20 A-level psychology pupils in two schools. Mentors showed significant increases in two of nine psychological literacies, in self-efficacy but not self-esteem, were highly satisfie...

Advancing career counseling and employment support for survivors: an intervention evaluation.

Science.gov (United States)

Davidson, M Meghan; Nitzel, Camie; Duke, Alysondra; Baker, Cynthia M; Bovaird, James A

2012-04-01

The purpose of this research was to conduct a replication-based and extension study examining the effectiveness of a 5-week career group counseling intervention, Advancing Career Counseling and Employment Support for Survivors (ACCESS; Chronister, 2008). The present study was conducted in a markedly different geographic region within a larger community as compared with the original investigation conducted by Chronister and McWhirter (2006). Women survivors of intimate partner violence (N = 73) participated in ACCESS, with career-search self-efficacy, perceived career barriers, perceived career supports, anxiety, and depression assessed at preintervention, postintervention, and 8-week follow-up. Women survivors demonstrated significant improvements in career-search self-efficacy and perceived career barriers at postintervention. Moreover, these same improvements were maintained at the 8-week follow-up assessment with the addition of significant improvements in perceived future financial supports, anxiety, and depression compared with preintervention scores. This work replicates the initial findings regarding the effectiveness of ACCESS with respect to career-search self-efficacy (Chronister & McWhirter, 2006) as well as extends the initial research to include improvements in perceived career barriers and perceived career supports. Moreover, the present study extends the work to include the mental health outcomes of anxiety and depression; results demonstrated improvements in these areas at 8-week follow-up. This investigation begins to fill a critical need for evaluated career-focused interventions for the underserved population of women survivors of intimate partner violence.

The effectiveness of an online support group for members of the community with depression: a randomised controlled trial.

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Kathleen M Griffiths

Full Text Available BACKGROUND: Internet support groups (ISGs are popular, particularly among people with depression, but there is little high quality evidence concerning their effectiveness. AIM: The study aimed to evaluate the efficacy of an ISG for reducing depressive symptoms among community members when used alone and in combination with an automated Internet-based psychotherapy training program. METHOD: Volunteers with elevated psychological distress were identified using a community-based screening postal survey. Participants were randomised to one of four 12-week conditions: depression Internet Support Group (ISG, automated depression Internet Training Program (ITP, combination of the two (ITP+ISG, or a control website with delayed access to e-couch at 6 months. Assessments were conducted at baseline, post-intervention, 6 and 12 months. RESULTS: There was no change in depressive symptoms relative to control after 3 months of exposure to the ISG. However, both the ISG alone and the combined ISG+ITP group showed significantly greater reduction in depressive symptoms at 6 and 12 months follow-up than the control group. The ITP program was effective relative to control at post-intervention but not at 6 months. CONCLUSIONS: ISGs for depression are promising and warrant further empirical investigation. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN65657330.

PhysioDirect: Supporting physiotherapists to deliver telephone assessment and advice services within the context of a randomised trial

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Bishop, Annette; Gamlin, Jill; Hall, Jeanette; Hopper, Cherida; Foster, Nadine E.

2013-01-01

Physiotherapy-led telephone assessment and advice services for patients with musculoskeletal problems have been developed in many services in the UK, but high quality trial data on clinical and cost effectiveness has been lacking. In order to address this ‘The PhysioDirect trial’ (ISRCTN55666618), was a pragmatic randomised trial of a PhysioDirect telephone assessment and advice service. This paper describes the PhysioDirect system used in the trial and how physiotherapists were trained and supported to use the system and deliver the PhysioDirect service. The PhysioDirect system used in the trial was developed in Huntingdon and now serves a population of 350,000 people. When initiating or providing physiotherapy-led telephone assessment and advice services training and support for physiotherapists delivering care in this way is essential. An enhanced skill set is required for telephone assessment and advice particularly in listening and communication skills. In addition to an initial training programme, even experienced physiotherapists benefit from a period of skill consolidation to become proficient and confident in assessing patients and delivering care using the telephone. A computer-based system assists the delivery of a physiotherapy-led musculoskeletal assessment and advice service. Clinical Trials Registration Number (ISRCTN55666618). PMID:23219629

Effectiveness of personalised feedback alone or combined with peer support to improve physical activity in sedentary older Malays with type 2 diabetes: A randomised controlled trial

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Shariff-Ghazali eSazlina

2015-07-01

Full Text Available Introduction: Regular physical activity is an important aspect of self management among older people with type 2 diabetes but many remain inactive. Interventions to improve physical activity levels have been studied but few studies have evaluated the effects of personalised feedback or peer support; and there was no study on older people of Asian heritage. Hence, this trial evaluated whether personalised feedback (PF only or combined with peer support (PS improves physical activity among older Malays with type 2 diabetes (T2DM compared to usual care only. Materials and methods: A three arm randomised controlled trial was conducted in a primary healthcare clinic in Malaysia. 69 sedentary Malays aged 60 years and older with T2DM who received usual diabetes care were randomised to PF or PS interventions or as controls for 12 weeks with follow-ups at weeks 24 and 36. Intervention groups performed unsupervised walking activity and received written feedback on physical activity. The PS group also received group and telephone contacts from trained peer mentors. The primary outcome was pedometer steps. Secondary outcomes were self-reported physical activity, cardiovascular risk factors, cardiorespiratory fitness, balance, quality of life and psychosocial wellbeing. Results: 52 (75.4% completed the 36-week study. The PS group showed greater daily pedometer readings than the PF and controls (p=0.001. The PS group also had greater improvement in weekly duration (p<0.001 and frequency (p<0.001 of moderate intensity physical activity, scores on the Physical Activity Scale for Elderly (p=0.003, six minute walk test (p<0.001 and social support from friends (p=0.032 than PF and control groups. Conclusions: The findings suggest personalised feedback combined with peer support in older Malays with T2DM improved their physical activity levels, cardiorespiratory fitness and support from friends. Trial registration: Current Controlled Trials ISRCTN71447000.

Self-learning basic life support: A randomised controlled trial on learning conditions.

Science.gov (United States)

Pedersen, Tina Heidi; Kasper, Nina; Roman, Hari; Egloff, Mike; Marx, David; Abegglen, Sandra; Greif, Robert

2018-05-01

To investigate whether pure self-learning without instructor support, resulted in the same BLS-competencies as facilitator-led learning, when using the same commercially available video BLS teaching kit. First-year medical students were randomised to either BLS self-learning without supervision or facilitator-led BLS-teaching. Both groups used the MiniAnne kit (Laerdal Medical, Stavanger, Norway) in the students' local language. Directly after the teaching and three months later, all participants were tested on their BLS-competencies in a simulated scenario, using the Resusci Anne SkillReporter™ (Laerdal Medical, Stavanger, Norway). The primary outcome was percentage of correct cardiac compressions three months after the teaching. Secondary outcomes were all other BLS parameters recorded by the SkillReporter and parameters from a BLS-competence rating form. 240 students were assessed at baseline and 152 students participated in the 3-month follow-up. For our primary outcome, the percentage of correct compressions, we found a median of 48% (interquartile range (IQR) 10-83) for facilitator-led learning vs. 42% (IQR 14-81) for self-learning (p = 0.770) directly after the teaching. In the 3-month follow-up, the rate of correct compressions dropped to 28% (IQR 6-59) for facilitator-led learning (p = 0.043) and did not change significantly in the self-learning group (47% (IQR 12-78), p = 0.729). Self-learning is not inferior to facilitator-led learning in the short term. Self-learning resulted in a better retention of BLS-skills three months after training compared to facilitator-led training. Copyright © 2018 Elsevier B.V. All rights reserved.

Peer support for family carers of people with dementia, alone or in combination with group reminiscence in a factorial design: study protocol for a randomised controlled trial

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Wenborn Jennifer

2011-09-01

Full Text Available Abstract Background Peer support interventions can improve carer wellbeing and interventions that engage both the carer and person with dementia can have significant mutual benefits. Existing research has been criticised for inadequate rigour of design or reporting. This paper describes the protocol for a complex trial that evaluates one-to-one peer support and a group reminiscence programme, both separately and together, in a factorial design. Design A 2 × 2 factorial multi-site randomised controlled trial of individual peer support and group reminiscence interventions for family carers and people with dementia in community settings in England, addressing both effectiveness and cost-effectiveness. Discussion The methods described in this protocol have implications for research into psychosocial interventions, particularly complex interventions seeking to test both individual and group approaches. Trial Registration ISRCTN37956201

Effectiveness of a Hospital-Based Work Support Intervention for Female Cancer Patients – A Multi-Centre Randomised Controlled Trial

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Tamminga, Sietske J.; Verbeek, Jos H. A. M.; Bos, Monique M. E. M.; Fons, Guus; Kitzen, Jos J. E. M.; Plaisier, Peter W.; Frings-Dresen, Monique H. W.; de Boer, Angela G. E. M.

2013-01-01

Objective One key aspect of cancer survivorship is return-to-work. Unfortunately, many cancer survivors face problems upon their return-to-work. For that reason, we developed a hospital-based work support intervention aimed at enhancing return-to-work. We studied effectiveness of the intervention compared to usual care for female cancer patients in a multi-centre randomised controlled trial. Methods Breast and gynaecological cancer patients who were treated with curative intent and had paid work were randomised to the intervention group (n = 65) or control group (n = 68). The intervention involved patient education and support at the hospital and improvement of communication between treating and occupational physicians. In addition, we asked patient's occupational physician to organise a meeting with the patient and the supervisor to make a concrete gradual return-to-work plan. Outcomes at 12 months of follow-up included rate and time until return-to-work (full or partial), quality of life, work ability, work functioning, and lost productivity costs. Time until return-to-work was analyzed with Kaplan-Meier survival analysis. Results Return-to-work rates were 86% and 83% (p = 0.6) for the intervention group and control group when excluding 8 patients who died or with a life expectancy of months at follow-up. Median time from initial sick leave to partial return-to-work was 194 days (range 14–435) versus 192 days (range 82–465) (p = 0.90) with a hazard ratio of 1.03 (95% CI 0.64–1.6). Quality of life and work ability improved statistically over time but did not differ statistically between groups. Work functioning and costs did not differ statistically between groups. Conclusion The intervention was easily implemented into usual psycho-oncological care and showed high return-to-work rates. We failed to show any differences between groups on return-to-work outcomes and quality of life scores. Further research is needed to study which aspects of

34 CFR 380.5 - What activities may the Secretary fund under community-based supported employment projects?

Science.gov (United States)

2010-07-01

... development, including work site modification and use of advanced learning technology for skills training. (3) On-the-job training. (4) Job placement. (5) Application of rehabilitation technology in providing... EDUCATION SPECIAL PROJECTS AND DEMONSTRATIONS FOR PROVIDING SUPPORTED EMPLOYMENT SERVICES TO INDIVIDUALS...

Financial hardship, mastery and social support: Explaining poor mental health amongst the inadequately employed using data from the HILDA survey.

Science.gov (United States)

Crowe, Laura; Butterworth, Peter; Leach, Liana

2016-12-01

This study analysed data from the Household Income and Labour Dynamics in Australia (HILDA) Survey to examine the relationship between employment status and mental health, and the mediating effects of financial hardship, mastery and social support. In addition, the study sought to explore the effects of duration of unemployment on mental health. The primary analysis used three waves of data from the HILDA Survey with 4965 young adult respondents. Longitudinal population-averaged logistic regression models assessed the association of employment status and mental health, including the contribution of mastery, financial hardship and social support in explaining this association between employment groups (unemployed vs. employed; under employed vs. employed). Sensitivity analyses utilised a fixed-effects approach and also considered the full-range of working-age respondents. Regression analysis was used to explore the effect of duration of unemployment on mental health. Respondents' who identified as unemployed or underemployed were at higher risk of poor mental health outcomes when compared to their employed counterparts. This association was ameliorated when accounting for mastery, financial hardship and social support for the unemployed, and was fully mediated for the underemployed. The fixed-effects models showed the transition to unemployment was associated with a decline in mental health and that mastery in particular contributed to that change. The same results were found with a broader age range of respondents. Finally, the relationship between duration of unemployment and mental health was not linear, with mental health showing marked decline across the first 9 weeks of unemployment. Mastery, social support and financial hardship are important factors in understanding the association of poor mental health with both unemployment and underemployment. Furthermore, the results suggest that the most deleterious effects on mental health may occur in the first two

Financial hardship, mastery and social support: Explaining poor mental health amongst the inadequately employed using data from the HILDA survey

Directory of Open Access Journals (Sweden)

Laura Crowe

2016-12-01

Full Text Available Objective: This study analysed data from the Household Income and Labour Dynamics in Australia (HILDA Survey to examine the relationship between employment status and mental health, and the mediating effects of financial hardship, mastery and social support. In addition, the study sought to explore the effects of duration of unemployment on mental health. Methods: The primary analysis used three waves of data from the HILDA Survey with 4965 young adult respondents. Longitudinal population-averaged logistic regression models assessed the association of employment status and mental health, including the contribution of mastery, financial hardship and social support in explaining this association between employment groups (unemployed vs. employed; under employed vs. employed. Sensitivity analyses utilised a fixed-effects approach and also considered the full-range of working-age respondents. Regression analysis was used to explore the effect of duration of unemployment on mental health. Results: Respondents’ who identified as unemployed or underemployed were at higher risk of poor mental health outcomes when compared to their employed counterparts. This association was ameliorated when accounting for mastery, financial hardship and social support for the unemployed, and was fully mediated for the underemployed. The fixed-effects models showed the transition to unemployment was associated with a decline in mental health and that mastery in particular contributed to that change. The same results were found with a broader age range of respondents. Finally, the relationship between duration of unemployment and mental health was not linear, with mental health showing marked decline across the first 9 weeks of unemployment. Conclusions and implications: Mastery, social support and financial hardship are important factors in understanding the association of poor mental health with both unemployment and underemployment. Furthermore, the results suggest

Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre, randomised controlled trial: design and methodology.

Science.gov (United States)

Gazzard, Gus; Konstantakopoulou, Evgenia; Garway-Heath, David; Barton, Keith; Wormald, Richard; Morris, Stephen; Hunter, Rachael; Rubin, Gary; Buszewicz, Marta; Ambler, Gareth; Bunce, Catey

2018-05-01

The Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open-angle glaucoma (POAG) or ocular hypertension (OHT). The LiGHT Trial is a prospective, unmasked, multicentre, pragmatic, randomised controlled trial. 718 previously untreated patients with POAG or OHT were recruited at six collaborating centres in the UK between 2012 and 2014. The trial comprises two treatment arms: initial SLT followed by conventional medical therapy as required, and medical therapy without laser therapy. Randomisation was provided online by a web-based randomisation service. Participants will be monitored for 3 years, according to routine clinical practice. The target intraocular pressure (IOP) was set at baseline according to an algorithm, based on disease severity and lifetime risk of loss of vision at recruitment, and subsequently adjusted on the basis of IOP control, optic disc and visual field. The primary outcome measure is health-related quality of life (HRQL) (EQ-5D five-level). Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index, Glaucoma Symptom Scale, Glaucoma Quality of Life, objective measures of pathway effectiveness, visual function and safety profiles and concordance. A single main analysis will be performed at the end of the trial on an intention-to-treat basis. The LiGHT Trial is a multicentre, pragmatic, randomised clinical trial that will provide valuable data on the relative HRQL, clinical effectiveness and cost-effectiveness of SLT and topical IOP-lowering medication. ISRCTN32038223, Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Randomised cluster trial to support informed parental decision-making for the MMR vaccine

Directory of Open Access Journals (Sweden)

Bekker Hilary

2011-06-01

Full Text Available Abstract Background In the UK public concern about the safety of the combined measles, mumps and rubella [MMR] vaccine continues to impact on MMR coverage. Whilst the sharp decline in uptake has begun to level out, first and second dose uptake rates remain short of that required for population immunity. Furthermore, international research consistently shows that some parents lack confidence in making a decision about MMR vaccination for their children. Together, this work suggests that effective interventions are required to support parents to make informed decisions about MMR. This trial assessed the impact of a parent-centred, multi-component intervention (balanced information, group discussion, coaching exercise on informed parental decision-making for MMR. Methods This was a two arm, cluster randomised trial. One hundred and forty two UK parents of children eligible for MMR vaccination were recruited from six primary healthcare centres and six childcare organisations. The intervention arm received an MMR information leaflet and participated in the intervention (parent meeting. The control arm received the leaflet only. The primary outcome was decisional conflict. Secondary outcomes were actual and intended MMR choice, knowledge, attitude, concern and necessity beliefs about MMR and anxiety. Results Decisional conflict decreased for both arms to a level where an 'effective' MMR decision could be made one-week (effect estimate = -0.54, p Conclusions Whilst both the leaflet and the parent meeting reduced parents' decisional conflict, the parent meeting appeared to enable parents to act upon their decision leading to vaccination uptake.

Can a documentary increase help-seeking intentions in men? A randomised controlled trial.

Science.gov (United States)

King, Kylie Elizabeth; Schlichthorst, Marisa; Spittal, Matthew J; Phelps, Andrea; Pirkis, Jane

2018-01-01

We investigated whether a public health intervention-a three-part documentary called Man Up which explored the relationship between masculinity and mental health, well-being and suicidality-could increase men's intentions to seek help for personal and emotional problems. We recruited men aged 18 years or over who were not at risk of suicide to participate in a double-blind randomised controlled trial. Participants were randomly assigned (1:1) via computer randomisation to view Man Up (the intervention) or a control documentary. We hypothesised that 4 weeks after viewing Man Up participants would report higher levels of intention to seek help than those who viewed the control documentary. Our primary outcome was assessed using the General Help Seeking Questionnaire, and was analysed for all participants. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12616001169437, Universal Trial Number: U1111-1186-1459) and was funded by the Movember Foundation. Three hundred and fifty-four men were assessed for eligibility for the trial and randomised to view Man Up or the control documentary. Of these, 337 completed all stages (nine participants were lost to follow-up in the intervention group and eight in the control group). Linear regression analysis showed a significant increase in intentions to seek help in the intervention group, but not in the control group (coef.=2.06, 95% CI 0.48 to 3.63, P=0.01). Our trial demonstrates the potential for men's health outcomes to be positively impacted by novel, media-based public health interventions that focus on traditional masculinity. ACTRN12616001169437, Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

Science.gov (United States)

Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

2014-07-16

To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

Grid Frequency Support by Single-Phase Electric Vehicles Employing an Innovative Virtual Inertia Controller

DEFF Research Database (Denmark)

Rezkalla, Michel M.N.; Zecchino, Antonio; Pertl, Michael

2016-01-01

The displacement of conventional generation by converter connected resources reduces the available rotational inertia in the power system, which leads to faster frequency dynamics and consequently a less stable frequency behavior. Virtual inertia, employing energy storage systems, could be used...... of adjusting the battery charging process (i.e., power flow) according to pre-defined algorithms. On the other hand, in case of islanded operation (i.e., low inertia), some of the EV's technical constraints might cause oscillations. This study presents two control algorithms which show that the EVs are capable...... of providing virtual inertia support. The first controller employs a traditional droop control, while the second one is equipped with an innovative control algorithm to eliminate likely oscillations. It is shown that, the proposed innovative control algorithm compared to the traditional droop control, assures...

Study protocol: Improving patient choice in treating low back pain (IMPACT - LBP: A randomised controlled trial of a decision support package for use in physical therapy

Directory of Open Access Journals (Sweden)

Tysall Colin

2011-02-01

Full Text Available Abstract Background Low back pain is a common and costly condition. There are several treatment options for people suffering from back pain, but there are few data on how to improve patients' treatment choices. This study will test the effects of a decision support package (DSP, designed to help patients seeking care for back pain to make better, more informed choices about their treatment within a physiotherapy department. The package will be designed to assist both therapist and patient. Methods/Design Firstly, in collaboration with physiotherapists, patients and experts in the field of decision support and decision aids, we will develop the DSP. The work will include: a literature and evidence review; secondary analysis of existing qualitative data; exploration of patients' perspectives through focus groups and exploration of experts' perspectives using a nominal group technique and a Delphi study. Secondly, we will carry out a pilot single centre randomised controlled trial within NHS Coventry Community Physiotherapy. We will randomise physiotherapists to receive either training for the DSP or not. We will randomly allocate patients seeking treatment for non specific low back pain to either a physiotherapist trained in decision support or to receive usual care. Our primary outcome measure will be patient satisfaction with treatment at three month follow-up. We will also estimate the cost-effectiveness of the intervention, and assess the value of conducting further research. Discussion Informed shared decision-making should be an important part of any clinical consultation, particularly when there are several treatments, which potentially have moderate effects. The results of this pilot will help us determine the benefits of improving the decision-making process in clinical practice on patient satisfaction. Trial registration Current Controlled Trials ISRCTN46035546

An equivalence evaluation of a nurse-moderated group-based internet support program for new mothers versus standard care: a pragmatic preference randomised controlled trial

Science.gov (United States)

2014-01-01

Background All mothers in South Australia are offered a clinic or home-visit by a Child and Family Health community nurse in the initial postnatal weeks. Subsequent support is available on request from staff in community clinics and from a telephone helpline. The aim of the present study is to compare equivalence of a single clinic-based appointment plus a nurse-moderated group-based internet intervention when infants were aged 0–6 months versus a single home-visit together with subsequent standard services (the latter support was available to mothers in both study groups). Methods/Design The evaluation utilised a pragmatic preference randomised trial comparing the equivalence of outcomes for mothers and infants across the two study groups. Eligible mothers were those whose services were provided by nurses working in one of six community clinics in the metropolitan region of Adelaide. Mothers were excluded if they did not have internet access, required an interpreter, or their nurse clinician recommended that they not participate due to issues such as domestic violence or substance abuse. Randomisation was based on the service identification number sequentially assigned to infants when referred to the Child and Family Health Services from birthing units (this was done by administrative staff who had no involvement in recruiting mothers, delivering the intervention, or analyzing results for the study). Consistent with design and power calculations, 819 mothers were recruited to the trial. The primary outcomes for the trial are parents’ sense of competence and self-efficacy measured using standard self-report questionnaires. Secondary outcomes include the quality of mother-infant relationships, maternal social support, role satisfaction and maternal mental health, infant social-emotional and language development, and patterns of service utilisation. Maternal and infant outcomes will be evaluated using age-appropriate questionnaires when infants are aged <2 months

Lay health supporters aided by a mobile phone messaging system to improve care of villagers with schizophrenia in Liuyang, China: protocol for a randomised control trial.

Science.gov (United States)

Xu, Dong Roman; Gong, Wenjie; Caine, Eric D; Xiao, Shuiyuan; Hughes, James P; Ng, Marie; Simoni, Jane; He, Hua; Smith, Kirk L; Brown, Henry Shelton; Gloyd, Stephen

2016-01-20

Schizophrenia is a severe, chronic and disabling mental illness. Non-adherence to medication and relapse may lead to poorer patient function. This randomised controlled study, under the acronym LEAN (Lay health supporter, e-platform, award, and iNtegration), is designed to improve medication adherence and high relapse among people with schizophrenia in resource poor settings. The community-based LEAN has four parts: (1) Lay health supporters (LHSs), mostly family members who will help supervise patient medication, monitor relapse and side effects, and facilitate access to care, (2) an E-platform to support two-way mobile text and voice messaging to remind patients to take medication; and alert LHSs when patients are non-adherent, (3) an Award system to motivate patients and strengthen LHS support, and (4) iNtegration of the efforts of patients and LHSs with those of village doctors, township mental health administrators and psychiatrists via the e-platform. A random sample of 258 villagers with schizophrenia will be drawn from the schizophrenic '686' Program registry for the 9 Xiang dialect towns of the Liuyang municipality in China. The sample will be further randomised into a control group and a treatment group of equal sizes, and each group will be followed for 6 months after launch of the intervention. The primary outcome will be medication adherence as measured by pill counts and supplemented by pharmacy records. Other outcomes include symptoms and level of function. Outcomes will be assessed primarily when patients present for medication refill visits scheduled every 2 months over the 6-month follow-up period. Data from the study will be analysed using analysis of covariance for the programme effect and an intent-to-treat approach. University of Washington: 49464 G; Central South University: CTXY-150002-6. Results will be published in peer-reviewed journals with deidentified data made available on FigShare. ChiCTR-ICR-15006053; Pre-results. Published by the

Lay health supporters aided by a mobile phone messaging system to improve care of villagers with schizophrenia in Liuyang, China: protocol for a randomised control trial

Science.gov (United States)

Gong, Wenjie; Caine, Eric D; Xiao, Shuiyuan; Hughes, James P; Ng, Marie; Simoni, Jane; He, Hua; Smith, Kirk L; Brown, Henry Shelton; Gloyd, Stephen

2016-01-01

Introduction Schizophrenia is a severe, chronic and disabling mental illness. Non-adherence to medication and relapse may lead to poorer patient function. This randomised controlled study, under the acronym LEAN (Lay health supporter, e-platform, award, and iNtegration), is designed to improve medication adherence and high relapse among people with schizophrenia in resource poor settings. Methods/analysis The community-based LEAN has four parts: (1) Lay health supporters (LHSs), mostly family members who will help supervise patient medication, monitor relapse and side effects, and facilitate access to care, (2) an E-platform to support two-way mobile text and voice messaging to remind patients to take medication; and alert LHSs when patients are non-adherent, (3) an Award system to motivate patients and strengthen LHS support, and (4) iNtegration of the efforts of patients and LHSs with those of village doctors, township mental health administrators and psychiatrists via the e-platform. A random sample of 258 villagers with schizophrenia will be drawn from the schizophrenic ‘686’ Program registry for the 9 Xiang dialect towns of the Liuyang municipality in China. The sample will be further randomised into a control group and a treatment group of equal sizes, and each group will be followed for 6 months after launch of the intervention. The primary outcome will be medication adherence as measured by pill counts and supplemented by pharmacy records. Other outcomes include symptoms and level of function. Outcomes will be assessed primarily when patients present for medication refill visits scheduled every 2 months over the 6-month follow-up period. Data from the study will be analysed using analysis of covariance for the programme effect and an intent-to-treat approach. Ethics and dissemination University of Washington: 49464 G; Central South University: CTXY-150002-6. Results will be published in peer-reviewed journals with deidentified data made available on

Effect of Internet peer-support groups on psychosocial adjustment to cancer

DEFF Research Database (Denmark)

Høybye, Mette Terp; Dalton, S O; Deltour, I

2010-01-01

BACKGROUND: We conducted a randomised study to investigate whether providing a self-guided Internet support group to cancer patients affected mood disturbance and adjustment to cancer. METHODS: Baseline and 1-, 6- and 12-month assessments were conducted from 2004 to 2006 at a national rehabilitat......BACKGROUND: We conducted a randomised study to investigate whether providing a self-guided Internet support group to cancer patients affected mood disturbance and adjustment to cancer. METHODS: Baseline and 1-, 6- and 12-month assessments were conducted from 2004 to 2006 at a national...... rehabilitation centre in Denmark. A total of 58 rehabilitation course weeks including 921 survivors of various cancers were randomly assigned to a control or an intervention group by cluster randomisation. The intervention was a lecture on the use of the Internet for support and information followed...... by participation in an Internet support group. Outcome measures included self-reported mood disturbance, adjustment to cancer and self-rated health. Differences in scores were compared between the control group and the intervention group. RESULTS: The effect of the intervention on mood disturbance and adjustment...

Effect of a Primary Care Walking Intervention with and without Nurse Support on Physical Activity Levels in 45- to 75-Year-Olds: The Pedometer And Consultation Evaluation (PACE-UP Cluster Randomised Clinical Trial.

Directory of Open Access Journals (Sweden)

Tess Harris

2017-01-01

Full Text Available Pedometers can increase walking and moderate-to-vigorous physical activity (MVPA levels, but their effectiveness with or without support has not been rigorously evaluated. We assessed the effectiveness of a pedometer-based walking intervention in predominantly inactive adults, delivered by post or through primary care nurse-supported physical activity (PA consultations.A parallel three-arm cluster randomised trial was randomised by household, with 12-mo follow-up, in seven London, United Kingdom, primary care practices. Eleven thousand fifteen randomly selected patients aged 45-75 y without PA contraindications were invited. Five hundred forty-eight self-reporting achieving PA guidelines were excluded. One thousand twenty-three people from 922 households were randomised between 2012-2013 to one of the following groups: usual care (n = 338; postal pedometer intervention (n = 339; and nurse-supported pedometer intervention (n = 346. Of these, 956 participants (93% provided outcome data (usual care n = 323, postal n = 312, nurse-supported n = 321. Both intervention groups received pedometers, 12-wk walking programmes, and PA diaries. The nurse group was offered three PA consultations. Primary and main secondary outcomes were changes from baseline to 12 mo in average daily step-counts and time in MVPA (in ≥10-min bouts, respectively, measured objectively by accelerometry. Only statisticians were masked to group. Analysis was by intention-to-treat. Average baseline daily step-count was 7,479 (standard deviation [s.d.] 2,671, and average time in MVPA bouts was 94 (s.d. 102 min/wk. At 12 mo, mean steps/d, with s.d. in parentheses, were as follows: control 7,246 (2,671; postal 8,010 (2,922; and nurse support 8,131 (3,228. PA increased in both intervention groups compared with the control group; additional steps/d were 642 for postal (95% CI 329-955 and 677 for nurse support (95% CI 365-989; additional MVPA in bouts (min/wk were 33 for postal (95% CI

The Great Recession and Job Loss Spillovers : Impact of Tradable Employment Shocks on Supporting Services

OpenAIRE

Nguyen, Ha; Rezaei, Shawheen

2016-01-01

This paper explores the spillover effects of job losses via input linkages during the Great Recession. Exploiting exogenous variation in tradable employment shocks across U.S. counties, the paper finds that job losses in the tradable sectors cause further job losses in local supporting services. The result is not due to reverse causation, construction job losses, or credit shortages. In ad...

Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue - cohort study.

Science.gov (United States)

Lundh, Andreas; Barbateskovic, Marija; Hróbjartsson, Asbjørn; Gøtzsche, Peter C

2010-10-26

transparency in reporting of conflict of interest is an increasingly important aspect of publication in medical journals. Publication of large industry-supported trials may generate many citations and journal income through reprint sales and thereby be a source of conflicts of interest for journals. We investigated industry-supported trials' influence on journal impact factors and revenue. we sampled six major medical journals (Annals of Internal Medicine, Archives of Internal Medicine, BMJ, JAMA, The Lancet, and New England Journal of Medicine [NEJM]). For each journal, we identified randomised trials published in 1996-1997 and 2005-2006 using PubMed, and categorized the type of financial support. Using Web of Science, we investigated citations of industry-supported trials and the influence on journal impact factors over a ten-year period. We contacted journal editors and retrieved tax information on income from industry sources. The proportion of trials with sole industry support varied between journals, from 7% in BMJ to 32% in NEJM in 2005-2006. Industry-supported trials were more frequently cited than trials with other types of support, and omitting them from the impact factor calculation decreased journal impact factors. The decrease varied considerably between journals, with 1% for BMJ to 15% for NEJM in 2007. For the two journals disclosing data, income from the sales of reprints contributed to 3% and 41% of the total income for BMJ and The Lancet in 2005-2006. publication of industry-supported trials was associated with an increase in journal impact factors. Sales of reprints may provide a substantial income. We suggest that journals disclose financial information in the same way that they require them from their authors, so that readers can assess the potential effect of different types of papers on journals' revenue and impact.

Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue - cohort study.

Directory of Open Access Journals (Sweden)

Andreas Lundh

2010-10-01

Full Text Available BACKGROUND: transparency in reporting of conflict of interest is an increasingly important aspect of publication in medical journals. Publication of large industry-supported trials may generate many citations and journal income through reprint sales and thereby be a source of conflicts of interest for journals. We investigated industry-supported trials' influence on journal impact factors and revenue. METHODS AND FINDINGS: we sampled six major medical journals (Annals of Internal Medicine, Archives of Internal Medicine, BMJ, JAMA, The Lancet, and New England Journal of Medicine [NEJM]. For each journal, we identified randomised trials published in 1996-1997 and 2005-2006 using PubMed, and categorized the type of financial support. Using Web of Science, we investigated citations of industry-supported trials and the influence on journal impact factors over a ten-year period. We contacted journal editors and retrieved tax information on income from industry sources. The proportion of trials with sole industry support varied between journals, from 7% in BMJ to 32% in NEJM in 2005-2006. Industry-supported trials were more frequently cited than trials with other types of support, and omitting them from the impact factor calculation decreased journal impact factors. The decrease varied considerably between journals, with 1% for BMJ to 15% for NEJM in 2007. For the two journals disclosing data, income from the sales of reprints contributed to 3% and 41% of the total income for BMJ and The Lancet in 2005-2006. CONCLUSIONS: publication of industry-supported trials was associated with an increase in journal impact factors. Sales of reprints may provide a substantial income. We suggest that journals disclose financial information in the same way that they require them from their authors, so that readers can assess the potential effect of different types of papers on journals' revenue and impact.

Cost-effectiveness of supported employment adapted for people with affective disorders.

Science.gov (United States)

Saha, Sanjib; Bejerholm, Ulrika; Gerdtham, Ulf-G; Jarl, Johan

2018-04-01

The individual enabling and support (IES) model was effective in gaining competitive employment for people with affective disorders compared with traditional vocational rehabilitation (TVR) services in a randomized controlled trial in a Swedish setting. The object of this study is to perform a cost-effectiveness analysis of IES comparing to TVR. We considered the costs of intervention and productivity gain due to increased competitive employment. We estimated quality of life using EuroQol 5 Dimension (EQ-5D) and Manchester Short Assessment of Quality of Life (MANSA) scale. EQ-5D was translated into quality-adjusted life-years (QALY), using the UK, Danish, and Swedish tariffs. We performed the analysis from a societal perspective with a one-year timeframe. The cost of IES was €7247 lower per person per year (2014 prices) compared to TVR. There were no significant differences in QALY improvement within or between groups. However, quality of life measured by the MANSA scale significantly improved over the study period in IES. Besides the small sample size, details on the intervention costs for both IES and TVR group were unavailable and had to be obtained from external sources. Implementation of IES for people with affective disorders is most likely cost-saving and is potentially even dominating TVR, although a larger trial is required to establish this.

Psychological distress in Canada: the role of employment and reasons of non-employment.

Science.gov (United States)

Marchand, Alain; Drapeau, Aline; Beaulieu-Prévost, Dominic

2012-11-01

This study investigated variations in psychological distress in a large sample of the Canadian population according to employment status, occupation, work organization conditions, reasons for non-employment, stress and support outside the work environment, family situation and individual characteristics. Data came from cycle 4 (2000-1) of the Canadian National Population Health Survey conducted by Statistics Canada. Multiple regression analyses, adjusted for the family situation, the level of support from the social network and the individual characteristics, were carried out on a sample of 7258 individuals aged from 18 to 65 years. Occupation, social support at work, age, self-esteem, presence of children aged five and under and social support outside of the workplace were associated with lower levels of psychological distress, while permanent and temporary disability, psychological demands in the workplace, job insecurity, female gender, and stressful financial, marital and parental situations were related to higher levels of psychological distress. Findings from this study suggest that, in terms of psychological distress, having a job is not always better than non-employment, and that specific non-employment situations associate differently with psychological distress.

Weight Loss Maintenance for 2 Years after a 6-Month Randomised Controlled Trial Comparing Education-Only and Group-Based Support in Japanese Adults

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Yoshio Nakata

2014-11-01

Full Text Available Objective: Our previous study, a 6-month randomised controlled trial, demonstrated that a group-based support promoted weight loss as compared to an education-only intervention. The purpose of this study was to examine weight loss maintenance for 2 years. Methods: Originally, 188 overweight Japanese adults, aged 40-65 years, were randomly assigned to 3 groups: control, education-only or group-based support. After the 6-month intervention, 125 participants in the education-only and the group-based support groups were followed up for 2 years. The primary outcome was the amount of weight lost. The participants were retrospectively grouped into quartiles of percent weight loss for secondary analyses. Results: At the end of follow-up, the amount of weight lost in the education-only and the group-based support groups was the same (3.3 kg. Secondary analyses using data of those who completed the study (n = 100 revealed that the participants in the highest quartile of percent weight loss significantly increased their step counts and moderate-to-vigorous physical activity compared with the lowest quartile. No significant differences were observed in the energy intake among the four groups. Conclusion: The effects of group-based support disappear within 2 years. Increasing physical activity may be a crucial factor for successful maintenance of weight loss.

Effectiveness of an online social support intervention for caregivers of people with dementia: the study protocol of a randomised controlled trial.

Science.gov (United States)

Dam, Alieske E H; de Vugt, Marjolein E; van Boxtel, Martin P J; Verhey, Frans R J

2017-08-29

Caregivers of people with dementia (PwD) face burden, feelings of loneliness, and social isolation. Previous studies have shown promising effects of online e-health interventions. Using social media may facilitate support for dementia caregiver networks. In an iterative step-wise approach, a social support tool entitled "Inlife" was developed. This paper describes the design of a study evaluating the effects of Inlife and its process characteristics. A mixed-method, randomised controlled trial with 122 caregivers of PwD will be conducted. Participants will be assigned to either the Inlife social support intervention or a waiting-list control group. After 16 weeks, the control group will obtain access to the Inlife environment. Data will be collected at baseline (T 0 ) and at 8-week (T 1 ), 16-week (T 2 ) and 42-week follow up (T 3 ). The 16-week follow-up assessment (T 2 ) is the primary endpoint to evaluate the results on the primary and secondary outcomes, measured by self-reported questionnaires. The primary outcomes include feelings of caregiver competence and perceived social support. The secondary outcomes include received support, feelings of loneliness, psychological complaints (e.g., anxiety, stress), and quality of life. A process evaluation, including semi-structured interviews, will be conducted to examine the internal and external validity of the intervention. Using a mixed-method design, our study will provide valuable insights into the usability, effectiveness, and factors related to implementation of the Inlife intervention. Our study results will indicate whether Inlife could be a valuable social support resource in future routine dementia care. Dutch trial register, NTR6131 . Registered on 20 October 2016.

Youth employment in Egypt

OpenAIRE

Eekelen, Willem van; De Luca, Loretta; Ismail, Magwa

2001-01-01

Examines economic and social factors affecting youth employment in Egypt and describes three national programmes for the promotion of youth employment based on human resources development, direct job creation and support in self-employment and enterprise creation. Describes one public-private project in each case.

Working Mothers and the State: Under Which Conditions do governments spend much on maternal employment supporting policies?

NARCIS (Netherlands)

Koole, K.; Vis, B.

2012-01-01

Over the last years, the level of spending on maternal employment supporting policies has risen in most countries. Still, the variation across governments in this level is substantial. Under which conditions do governments spend relatively much? Drawing on the critical mass literature, we argue that

Randomised controlled trials cited in pharmaceutical advertisements targeting New Zealand health professionals: do they support the advertising claims and what is the risk of bias?

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Ma, Alison; Parkin, Lianne

2015-09-04

To determine whether pharmaceutical advertisement claims targeting health professionals were supported by the randomised controlled trials (RCTs) cited in the advertisements, and to assess the risk of bias in those trials. Pharmaceutical advertisements were obtained from New Zealand Doctor and Pharmacy Today for the period July 2013 to June 2014. All claims made regarding efficacy, safety, and indications were identified and RCTs cited to substantiate these claims were examined. A claim was defined as supported by an RCT if the conclusions drawn in the paper were consistent with the claim. The quality of the RCT was assessed separately, using the Cochrane Risk of Bias Assessment Tool. In 25 (19%) of the 133 instances in which an RCT was cited, the published paper did not support the promotional claim. Moreover, there were only 10 (8%) instances in which the claim was supported by an RCT with a low risk of bias. Of the 78 cited RCTs, only 14% had a low risk of bias, while 49% had an unclear risk and 37% had a high risk. A high proportion of advertisements failed to meet New Zealand regulatory requirements that claims "are valid and have been substantiated".

Active Play in After-school Programmes: development of an intervention and description of a matched-pair cluster-randomised trial assessing physical activity play in after-school programmes.

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Riiser, Kirsti; Helseth, Sølvi; Ellingsen, Hanna; Fallang, Bjørg; Løndal, Knut

2017-08-04

Interventions delivered in after-school programmes (ASPs) have the potential to become a means of ensuring adequate physical activity among schoolchildren. This requires a motivational climate, allowing for self-determined play. If trained, ASP staff may represent a valuable resource for supporting such play. Increasing knowledge and supportive skills among ASP staff may also potentially increase their motivation for work. The purpose of this article is to describe the development of the 'Active Play in ASP' intervention, which aims to promote physical activity among first graders attending ASP, and to present a protocol for a matched-pair cluster-randomised trial to evaluate the intervention. Informed by experiences from practice, evidence-based knowledge and theory, the intervention was developed in a stepwise process including focus group meetings and a small-scale pilot test. The intervention contains a course programme for ASP staff to increase their skills in how to support physical activity through play. In a cluster randomised controlled trial, the ASPs will be matched and randomly allocated to receive the 7-month intervention or to a control group. Outcomes will be assessed at baseline, after 7 and 19 months. First graders attending the ASPs included are eligible. The primary outcome will be accelerometer-determined minutes in moderate to vigorous physical activity in the ASP. The study uses a mixed methods approach including observations and interviews to provide rich descriptions of the concept of children's physical activity in ASP. Moreover, the trial will assess whether the ASP staff benefits from participation in the intervention in terms of increased work motivation. Lastly, process evaluations of programme fidelity, satisfaction and suggestions on improvement will be performed. The study is approved by the Data Protection Official for Research (reference no 46008). Results will be presented in conferences and peer-reviewed journals. Clinical Trials

Benefits of Employer Brand and the Supporting Trends

Directory of Open Access Journals (Sweden)

Hana Urbancová

2017-12-01

Full Text Available Shortage of qualified staff and constant struggle for talents along with the retention of most valuable employees belong to the hottest personnel issues for the majority of organizations nowadays. HR marketing can significantly help in these areas. Within HR marketing human resources officers become those marketers who strive to keep their organization’s name in the minds of all stakeholders, thus drawing their attention to organization’s qualities as an employer, and in such a way winning by taking care of the most talented employees. The aim of this paper is to determine and evaluate the benefits resulting from employer branding and also to identify the trends conducive to the strengthening of an employer’s brand. The data were obtained using a questionnaire survey (n = 492 in the selected Czech organizations. The results show that employer branding is an important element in all economic sectors and businesses can build their brands by focusing primarily on the stability of their current employees, their continuous development and their retaining of the most valuable knowledge. The article focuses on new strategic trends in building employer’s good brand and attracting the most knowledgable workers.

Effect of Evidence-Based Supported Employment vs Transitional Work on Achieving Steady Work Among Veterans With Posttraumatic Stress Disorder: A Randomized Clinical Trial.

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Davis, Lori L; Kyriakides, Tassos C; Suris, Alina M; Ottomanelli, Lisa A; Mueller, Lisa; Parker, Pamela E; Resnick, Sandra G; Toscano, Richard; Scrymgeour, Alexandra A; Drake, Robert E

2018-04-01

Posttraumatic stress disorder (PTSD) often interferes with a person's ability to obtain or sustain employment, which leads to premature exit from the labor force and reduced income. To determine whether individual placement and support (IPS)-supported employment is more effective than stepwise vocational rehabilitation involving transitional work assignments at helping veterans with PTSD attain steady, competitive employment. The Veterans Individual Placement and Support Toward Advancing Recovery (VIP-STAR) study was a prospective, multisite, randomized clinical trial that included 541 unemployed veterans with PTSD at 12 Veterans Affairs medical centers. Data were collected from December 23, 2013, to May 3, 2017. Intent-to-treat analysis was performed. Individual placement and support is a supported employment intervention that rapidly engages people with disabilities in community job development to obtain work based on their individual job preferences. Transitional work is a stepwise vocational rehabilitation intervention that assigns people temporarily to noncompetitive jobs as preparation for competitive employment in the community. A priori hypotheses were that, compared with those in transitional work, more participants in the IPS group would become steady workers (primary) and earn more income from competitive jobs (secondary) over 18 months. Steady worker was defined as holding a competitive job for at least 50% of the 18-month follow-up period. A total of 541 participants (n = 271 IPS; n = 270 transitional work) were randomized. Mean (SD) age was 42.2 (11) years; 99 (18.3%) were women, 274 (50.6%) were white, 225 (41.6%) were African American, and 90 (16.6%) were of Hispanic, Spanish, or Latino ethnicity. More participants in the IPS group achieved steady employment than in the transitional work group (105 [38.7%] vs 63 [23.3%]; odds ratio, 2.14; 95% CI, 1.46-3.14). A higher proportion of IPS participants attained any competitive job (186 [68.6%] vs

Long-term effect of aspirin on cancer risk in carriers of hereditary colorectal cancer: an analysis from the CAPP2 randomised controlled trial

DEFF Research Database (Denmark)

Burn, John; Gerdes, Anne-Marie; Macrae, Finlay

2011-01-01

Observational studies report reduced colorectal cancer in regular aspirin consumers. Randomised controlled trials have shown reduced risk of adenomas but none have employed prevention of colorectal cancer as a primary endpoint. The CAPP2 trial aimed to investigate the antineoplastic effects of as...

Action to Support Practices Implement Research Evidence (ASPIRE): protocol for a cluster-randomised evaluation of adaptable implementation packages targeting 'high impact' clinical practice recommendations in general practice.

Science.gov (United States)

Willis, Thomas A; Hartley, Suzanne; Glidewell, Liz; Farrin, Amanda J; Lawton, Rebecca; McEachan, Rosemary R C; Ingleson, Emma; Heudtlass, Peter; Collinson, Michelle; Clamp, Susan; Hunter, Cheryl; Ward, Vicky; Hulme, Claire; Meads, David; Bregantini, Daniele; Carder, Paul; Foy, Robbie

2016-02-29

There are recognised gaps between evidence and practice in general practice, a setting which provides particular challenges for implementation. We earlier screened clinical guideline recommendations to derive a set of 'high impact' indicators based upon criteria including potential for significant patient benefit, scope for improved practice and amenability to measurement using routinely collected data. We aim to evaluate the effectiveness and cost-effectiveness of a multifaceted, adaptable intervention package to implement four targeted, high impact recommendations in general practice. The research programme Action to Support Practice Implement Research Evidence (ASPIRE) includes a pair of pragmatic cluster-randomised trials which use a balanced incomplete block design. Clusters are general practices in West Yorkshire, United Kingdom (UK), recruited using an 'opt-out' recruitment process. The intervention package adapted to each recommendation includes combinations of audit and feedback, educational outreach visits and computerised prompts with embedded behaviour change techniques selected on the basis of identified needs and barriers to change. In trial 1, practices are randomised to adapted interventions targeting either diabetes control or risky prescribing and those in trial 2 to adapted interventions targeting either blood pressure control in patients at risk of cardiovascular events or anticoagulation in atrial fibrillation. The respective primary endpoints comprise achievement of all recommended target levels of haemoglobin A1c (HbA1c), blood pressure and cholesterol in patients with type 2 diabetes, a composite indicator of risky prescribing, achievement of recommended blood pressure targets for specific patient groups and anticoagulation prescribing in patients with atrial fibrillation. We are also randomising practices to a fifth, non-intervention control group to further assess Hawthorne effects. Outcomes will be assessed using routinely collected data

Strategies to improve recruitment to randomised trials.

Science.gov (United States)

Treweek, Shaun; Pitkethly, Marie; Cook, Jonathan; Fraser, Cynthia; Mitchell, Elizabeth; Sullivan, Frank; Jackson, Catherine; Taskila, Tyna K; Gardner, Heidi

2018-02-22

Recruiting participants to trials can be extremely difficult. Identifying strategies that improve trial recruitment would benefit both trialists and health research. To quantify the effects of strategies for improving recruitment of participants to randomised trials. A secondary objective is to assess the evidence for the effect of the research setting (e.g. primary care versus secondary care) on recruitment. We searched the Cochrane Methodology Review Group Specialised Register (CMR) in the Cochrane Library (July 2012, searched 11 February 2015); MEDLINE and MEDLINE In Process (OVID) (1946 to 10 February 2015); Embase (OVID) (1996 to 2015 Week 06); Science Citation Index & Social Science Citation Index (ISI) (2009 to 11 February 2015) and ERIC (EBSCO) (2009 to 11 February 2015). Randomised and quasi-randomised trials of methods to increase recruitment to randomised trials. This includes non-healthcare studies and studies recruiting to hypothetical trials. We excluded studies aiming to increase response rates to questionnaires or trial retention and those evaluating incentives and disincentives for clinicians to recruit participants. We extracted data on: the method evaluated; country in which the study was carried out; nature of the population; nature of the study setting; nature of the study to be recruited into; randomisation or quasi-randomisation method; and numbers and proportions in each intervention group. We used a risk difference to estimate the absolute improvement and the 95% confidence interval (CI) to describe the effect in individual trials. We assessed heterogeneity between trial results. We used GRADE to judge the certainty we had in the evidence coming from each comparison. We identified 68 eligible trials (24 new to this update) with more than 74,000 participants. There were 63 studies involving interventions aimed directly at trial participants, while five evaluated interventions aimed at people recruiting participants. All studies were in

Tailored educational supportive care programme on sleep quality and psychological distress in patients with heart failure: A randomised controlled trial.

Science.gov (United States)

Chang, Yia-Ling; Chiou, Ai-Fu; Cheng, Shu-Meng; Lin, Kuan-Chia

2016-09-01

Up to 74% of patients with heart failure report poor sleep in Taiwan. Poor symptom management or sleep hygiene may affect patients' sleep quality. An effective educational programme was important to improve patients' sleep quality and psychological distress. However, research related to sleep disturbance in patients with heart failure is limited in Taiwan. To examine the effects of a tailored educational supportive care programme on sleep disturbance and psychological distress in patients with heart failure. randomised controlled trial. Eighty-four patients with heart failure were recruited from an outpatient department of a medical centre in Taipei, Taiwan. Patients were randomly assigned to the intervention group (n=43) or the control group (n=41). Patients in the intervention group received a 12-week tailored educational supportive care programme including individualised education on sleep hygiene, self-care, emotional support through a monthly nursing visit at home, and telephone follow-up counselling every 2 weeks. The control group received routine nursing care. Data were collected at baseline, the 4th, 8th, and 12th weeks after patients' enrollment. Outcome measures included sleep quality, daytime sleepiness, anxiety, and depression. The intervention group exhibited significant improvement in the level of sleep quality and daytime sleepiness after 12 weeks of the supportive nursing care programme, whereas the control group exhibited no significant differences. Anxiety and depression scores were increased significantly in the control group at the 12th week (p.05). Compared with the control group, the intervention group had significantly greater improvement in sleep quality (β=-2.22, pquality and psychological distress in patients with heart failure. We suggested that this supportive nursing care programme should be applied to clinical practice in cardiovascular nursing. Copyright © 2016 Elsevier Ltd. All rights reserved.

Towards Employment: What Research Says About Support-to-Work in Relation to Psychiatric and Intellectual Disabilities.

Science.gov (United States)

Lövgren, Veronica; Markström, Urban; Sauer, Lennart

2017-01-01

This article presents an overview of research about support-to-work in relation to psychiatric and intellectual disabilities. The overview shows that support-to-work services are multifaceted, and that work can be seen as a tool for individual rehabilitation or as a set of goals to achieve. Providers are presented with specific components, which are characterized by systematic, targeted, and individualized interventions. The overview illustrates a need for long-term engagement and cooperation of and between welfare services and agents within the labor market to dissolve the Gordian knot that the transition from welfare interventions to employment seems to be.

Mii-vitaliSe: a pilot randomised controlled trial of a home gaming system (Nintendo Wii) to increase activity levels, vitality and well-being in people with multiple sclerosis.

Science.gov (United States)

Thomas, Sarah; Fazakarley, Louise; Thomas, Peter W; Collyer, Sarah; Brenton, Sarah; Perring, Steve; Scott, Rebecca; Thomas, Fern; Thomas, Charlotte; Jones, Kelly; Hickson, Jo; Hillier, Charles

2017-09-27

While the health and well-being benefits of physical activity are recognised, people with multiple sclerosis (MS) often face greater barriers than the general population. The Nintendo Wii potentially offers a fun, convenient way of overcoming some of these. The aim was to test the feasibility of conducting a definitive trial of the effectiveness and cost-effectiveness of Mii-vitaliSe; a home-based, physiotherapist-supported Nintendo Wii intervention. A single-centre wait-list randomised controlled study. MS service in secondary care. Ambulatory, relatively inactive people with clinically confirmed MS. Thirty participants were randomised to receive Mii-vitaliSe either immediately (for 12 months) or after a 6-month wait (for 6 months). Mii-vitaliSe consisted of two supervised Nintendo Wii familiarisation sessions in the hospital followed by home use (Wii Sports, Sports Resort and Fit Plus software) with physiotherapist support and personalised resources. Included self-reported physical activity levels, quality of life, mood, self-efficacy, fatigue and assessments of balance, gait, mobility and hand dexterity at baseline, 6 and 12 months. Interviews (n=25) explored participants' experiences and, at study end, the two Mii-vitaliSe facilitators' experiences of intervention delivery (main qualitative findings reported separately). Mean (SD) age was 49.3 (8.7) years, 90% female, with 47% diagnosed with MS Wii use across both groups over the initial 6-month intervention period was twice a week for 27 min/day. Mean cost of delivering Mii-vitaliSe was £684 per person. Mii-vitaliSe appears acceptable and a future trial feasible and warranted. These findings will inform its design. ISRCTN49286846. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Breastfeeding and employment: an assessment of employer attitudes.

Science.gov (United States)

Libbus, M Kay; Bullock, Linda F C

2002-08-01

Both research and anecdotal reports suggest that maternal employment is associated with failure to initiate breastfeeding and early breastfeeding attrition. The objective of this study was to describe the experience with and attitudes toward breastfeeding of a sample of employers in a small Midwestern city in the United States. Based on an analysis of 85 mail-out questionnaires, we found that less than half of the employers had personal experience with breastfeeding. A large percentage of the sample, however, indicated that they would be willing to facilitate women who wished to breastfeed or express milk in the workplace. However, these employers also stated that they saw little value to their business of supporting breastfeeding in the work environment. Thus, enhancement of breastfeeding opportunity in the work environment may come as a result of public and employer education but, more likely, will require some type of directive from official sources.

Does personality influence job acquisition and tenure in people with severe mental illness enrolled in supported employment programs?

Science.gov (United States)

Fortin, Guillaume; Lecomte, Tania; Corbière, Marc

2017-06-01

When employment difficulties in people with severe mental illness (SMI) occur, it could be partly linked to issues not specific to SMI, such as personality traits or problems. Despite the fact that personality has a marked influence on almost every aspect of work behavior, it has scarcely been investigated in the context of employment for people with SMI. We aimed to evaluate if personality was more predictive than clinical variables of different competitive work outcomes, namely acquisition of competitive employment, delay to acquisition and job tenure. A sample of 82 people with a SMI enrolled in supported employment programs (SEP) was recruited and asked to complete various questionnaires and interviews. Statistical analyses included logistic regressions and survival analyses (Cox regressions). Prior employment, personality problems and negative symptoms are significantly related to acquisition of a competitive employment and to delay to acquisition whereas the conscientiousness personality trait was predictive of job tenure. Our results point out the relevance of personality traits and problems as predictors of work outcomes in people with SMI registered in SEP. Future studies should recruit larger samples and also investigate these links with other factors related to work outcomes.

Effectiveness of recruitment to a smartphone-delivered nutrition intervention in New Zealand: analysis of a randomised controlled trial.

Science.gov (United States)

Volkova, Ekaterina; Michie, Jo; Corrigan, Callie; Sundborn, Gerhard; Eyles, Helen; Jiang, Yannan; Mhurchu, Cliona Ni

2017-07-02

Delivery of interventions via smartphone is a relatively new initiative in public health, and limited evidence exists regarding optimal strategies for recruitment. We describe the effectiveness of approaches used to recruit participants to a smartphone-enabled nutrition intervention trial. Internet and social media advertising, mainstream media advertising and research team networks were used to recruit New Zealand adults to a fully automated smartphone-delivered nutrition labelling trial (no face-to-face visits were required). Recruitment of Māori and Pacific participants was a key focus and ethically relevant recruitment materials and approaches were used where possible. The effectiveness of recruitment strategies was evaluated using Google Analytics, monitoring of study website registrations and randomisations, and self-reported participant data. The cost of the various strategies and associations with participant demographics were assessed. Over a period of 13 months, there were 2448 registrations on the study website, and 1357 eligible individuals were randomised into the study (55%). Facebook campaigns were the most successful recruitment strategy overall (43% of all randomised participants) and for all ethnic groups (Māori 44%, Pacific 44% and other 43%). Significant associations were observed between recruitment strategy and age (psmartphone-delivered trial. These approaches also reached diverse ethnic groups. However, more culturally appropriate recruitment strategies are likely to be necessary in studies where large numbers of participants from specific ethnic groups are sought. ACTRN12614000644662; Post-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Randomised trial of biofeedback training for encopresis

NARCIS (Netherlands)

van der Plas, R. N.; Benninga, M. A.; Redekop, W. K.; Taminiau, J. A.; Büller, H. A.

1996-01-01

To evaluate biofeedback training in children with encopresis and the effect on psychosocial function. Prospective controlled randomised study. PATIENT INTERVENTIONS: A multimodal treatment of six weeks. Children were randomised into two groups. Each group received dietary and toilet advice, enemas,

THE ROLE OF THE SOCIAL MEDIATOR WITHIN THE DISABILITY EMPLOYMENT SUPPORT SYSTEM

Directory of Open Access Journals (Sweden)

Maria Dorina PASCA

2014-04-01

Full Text Available For people with disabilities, to find a way to improve life quality by having a job and by developing independent living skills is a “sine qua non” condition for their social integration. The social mediator working within a disability employment support system facilitates the logistic implementation of a viable and plausible program, which can identify, and maintain a workplace for people with disabilities, and acts as a motivational guarantee of these persons’ chance for a better life while also providing life lessons to all of us. Hence, the major role of the social mediator is to develop a new cognitive structure of communication for disabled people so that they can act as our equals and not as marginalized human beings.

The Potential Positive Impact of Sup-ported Employment on the Oral Health Status, Attitudes and Behavior of Adults with Intellectual Disabilities

Directory of Open Access Journals (Sweden)

Vasileios Margaritis

2012-03-01

Full Text Available Introduction: Individuals with Intellectual Disabilities (ID con-stitute a unique but heterogeneous population, which includes a great variety of mental and developmental disorders, as well as congenital syndromes. Nowadays, many persons with mild or moderate ID, with specific training, can make considerable efforts to improve their lives, by having a job in either open or supported employment. On the other hand, since dental caries and periodontal diseases are among the most common secondary conditions affecting people with ID, oral diseases may detract the quality of life from disabled persons.The hypothesis: Employment (sheltered workshop, open or supported employment of persons with ID, may enable these individuals to improve their oral health status, attitudes and behavior, compared to the ID individuals who are not working, due to the development of specific socio-emotional characteristics and dexterities.Evaluation of the hypothesis: According to previous reports, employed people with ID demonstrated better self-esteem and greater autonomy, more satisfaction with their vocational/non-vocational ac-tivities and higher quality of life.

A systematic review of randomised control trials of sexual health interventions delivered by mobile technologies.

Science.gov (United States)

Burns, Kara; Keating, Patrick; Free, Caroline

2016-08-12

Sexually transmitted infections (STIs) pose a serious public health problem globally. The rapid spread of mobile technology creates an opportunity to use innovative methods to reduce the burden of STIs. This systematic review identified recent randomised controlled trials that employed mobile technology to improve sexual health outcomes. The following databases were searched for randomised controlled trials of mobile technology based sexual health interventions with any outcome measures and all patient populations: MEDLINE, EMBASE, PsycINFO, Global Health, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register, NHS Health Technology Assessment Database, and Web of Science (science and social science citation index) (Jan 1999-July 2014). Interventions designed to increase adherence to HIV medication were not included. Two authors independently extracted data on the following elements: interventions, allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. Trials were assessed for methodological quality using the Cochrane risk of bias tool. We calculated effect estimates using intention to treat analysis. A total of ten randomised trials were identified with nine separate study groups. No trials had a low risk of bias. The trials targeted: 1) promotion of uptake of sexual health services, 2) reduction of risky sexual behaviours and 3) reduction of recall bias in reporting sexual activity. Interventions employed up to five behaviour change techniques. Meta-analysis was not possible due to heterogeneity in trial assessment and reporting. Two trials reported statistically significant improvements in the uptake of sexual health services using SMS reminders compared to controls. One trial increased knowledge. One trial reported promising results in increasing condom use but no trial reported statistically significant increases in condom

Effectiveness of strategies incorporating training and support of traditional birth attendants on perinatal and maternal mortality: meta-analysis.

Science.gov (United States)

Wilson, Amie; Gallos, Ioannis D; Plana, Nieves; Lissauer, David; Khan, Khalid S; Zamora, Javier; MacArthur, Christine; Coomarasamy, Arri

2011-12-01

To assess the effectiveness of strategies incorporating training and support of traditional birth attendants on the outcomes of perinatal, neonatal, and maternal death in developing countries. Systematic review with meta-analysis. Medline, Embase, the Allied and Complementary Medicine database, British Nursing Index, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, BioMed Central, PsycINFO, Latin American and Caribbean Health Sciences Literature database, African Index Medicus, Web of Science, Reproductive Health Library, and Science Citation Index (from inception to April 2011), without language restrictions. Search terms were "birth attend*", "traditional midwife", "lay birth attendant", "dais", and "comadronas". Review methods We selected randomised and non-randomised controlled studies with outcomes of perinatal, neonatal, and maternal mortality. Two independent reviewers undertook data extraction. We pooled relative risks separately for the randomised and non-randomised controlled studies, using a random effects model. We identified six cluster randomised controlled trials (n=138 549) and seven non-randomised controlled studies (n=72 225) that investigated strategies incorporating training and support of traditional birth attendants. All six randomised controlled trials found a reduction in adverse perinatal outcomes; our meta-analysis showed significant reductions in perinatal death (relative risk 0.76, 95% confidence interval 0.64 to 0.88, Ptraditional birth attendants.

Applying the intention-to-treat principle in practice: Guidance on handling randomisation errors.

Science.gov (United States)

Yelland, Lisa N; Sullivan, Thomas R; Voysey, Merryn; Lee, Katherine J; Cook, Jonathan A; Forbes, Andrew B

2015-08-01

The intention-to-treat principle states that all randomised participants should be analysed in their randomised group. The implications of this principle are widely discussed in relation to the analysis, but have received limited attention in the context of handling errors that occur during the randomisation process. The aims of this article are to (1) demonstrate the potential pitfalls of attempting to correct randomisation errors and (2) provide guidance on handling common randomisation errors when they are discovered that maintains the goals of the intention-to-treat principle. The potential pitfalls of attempting to correct randomisation errors are demonstrated and guidance on handling common errors is provided, using examples from our own experiences. We illustrate the problems that can occur when attempts are made to correct randomisation errors and argue that documenting, rather than correcting these errors, is most consistent with the intention-to-treat principle. When a participant is randomised using incorrect baseline information, we recommend accepting the randomisation but recording the correct baseline data. If ineligible participants are inadvertently randomised, we advocate keeping them in the trial and collecting all relevant data but seeking clinical input to determine their appropriate course of management, unless they can be excluded in an objective and unbiased manner. When multiple randomisations are performed in error for the same participant, we suggest retaining the initial randomisation and either disregarding the second randomisation if only one set of data will be obtained for the participant, or retaining the second randomisation otherwise. When participants are issued the incorrect treatment at the time of randomisation, we propose documenting the treatment received and seeking clinical input regarding the ongoing treatment of the participant. Randomisation errors are almost inevitable and should be reported in trial publications. The

Using Part-Time Working to Support Graduate Employment: Needs and Perceptions of Employers

Science.gov (United States)

Evans, Carl; Maxfield, Tim; Gbadamosi, Gbolahan

2015-01-01

An exploration of the value attached to the work experience of graduates, and particularly the value of part-time working whilst studying for a degree, from an employer's perspective, is reported. A documentary analysis of graduate recruiters was conducted to assess the extent to which work experience was specified for graduate employment…

Efficacy of a global supportive skin care programme with hydrotherapy after non-metastatic breast cancer treatment: A randomised, controlled study.

Science.gov (United States)

Dalenc, F; Ribet, V; Rossi, A B; Guyonnaud, J; Bernard-Marty, C; de Lafontan, B; Salas, S; Ranc Royo, A-L; Sarda, C; Levasseur, N; Massabeau, C; Levecq, J-M; Dulguerova, P; Guerrero, D; Sibaud, V

2018-01-01

This study investigated the efficacy of post-treatment hydrotherapy as supportive care for management of persistent/long-lasting dermatologic adverse events (dAEs) induced in breast cancer survivors by adjuvant therapy, and its impact on quality of life (QoL). Patients in complete remission after standardised (neo)adjuvant chemotherapy, surgery and radiotherapy combination treatment for infiltrating HR+/HER2-breast carcinoma were enrolled in this randomised, multicentre controlled study 1-5 weeks after completing radiotherapy. The control group (CG, n = 33) received best supportive care and the treatment group (HG, n = 35) received 3-weeks of specific hydrotherapy. The primary criterion was change in QoL (QLQ-BR23) after hydrotherapy. Clinical grading of dAEs, cancer-related QoL (QLQ-C30), dermatologic QoL (DLQI) and general psychological well-being (PGWBI) were assessed. Significant dAEs were found at inclusion in both groups (n = 261). Most items showed significantly greater improvement in the HG versus CG group: QLQ-BR23 (breast [p = .0001] and arm symptoms [p = .0015], systemic therapy side effects [p = .0044], body image [p = .0139]), some dAE grading, DLQI (p = .0002) and PGWBI (p = .0028). Xerosis (88% of patients at inclusion) completely healed in all HG patients. Specific hydrotherapy is an effective supportive care for highly prevalent and long-lasting dAEs occurring after early breast cancer treatment, including chemotherapy, and leads to improved QoL and dermatologic toxicities. © 2017 John Wiley & Sons Ltd.

Formal plan for self-disclosure enhances supported employment outcomes among young people with severe mental illness.

Science.gov (United States)

McGahey, Ellie; Waghorn, Geoffrey; Lloyd, Chris; Morrissey, Shirley; Williams, Philip Lee

2016-04-01

Young people with mental illness experience high levels of unemployment, which can be related to stigma and discrimination. This may result from poor choices in disclosing personal information, such as their mental illness diagnosis, in the workplace. The aim of this study was to investigate the predictive validity of a formal plan to manage personal information (PMPI) during the early stages of supported employment. The focal question was: does the use of a brief structured PMPI lead to more employment outcomes for young people with a mental illness? A sample of 40 young unemployed mental health service users (mean age 23.9 years), who were also attending employment services on the Gold Coast, was asked about their disclosure preferences. If they preferred not to disclose at all, they did not complete a plan for managing personal information. If they preferred to disclose some personal information, they were provided with assistance to complete a PMPI. Baseline information was gathered from two equal groups of 20 individuals. Employment status was ascertained at a 6-week follow-up interview. Those who completed a plan to manage their personal information had 4.9 times greater odds of employment at 6 weeks than those who preferred not to disclose any personal information. A formal PMPI has promising predictive validity with respect to job seekers not opposed to pragmatic forms of self-disclosure. Further research is needed to examine other properties of this decision-making tool. © 2014 Wiley Publishing Asia Pty Ltd.

A pilot randomised controlled study of the mental health first aid eLearning course with UK medical students.

Science.gov (United States)

Davies, E Bethan; Beever, Emmeline; Glazebrook, Cris

2018-03-21

Medical students face many barriers to seeking out professional help for their mental health, including stigma relating to mental illness, and often prefer to seek support and advice from fellow students. Improving medical students' mental health literacy and abilities to support someone experiencing a mental health problem could reduce barriers to help seeking and improve mental health in this population. Mental Health First Aid (MHFA) is an evidence-based intervention designed to improve mental health literacy and ability to respond to someone with a mental health problem. This pilot randomised controlled trial aims to evaluate the MHFA eLearning course in UK medical students. Fifty-five medical students were randomised to receive six weeks access to the MHFA eLearning course (n = 27) or to a no-access control group (n = 28). Both groups completed baseline (pre-randomisation) and follow-up (six weeks post-randomisation) online questionnaires measuring recognition of a mental health problem, mental health first aid intentions, confidence to help a friend experiencing a mental health problem, and stigmatising attitudes. Course feedback was gathered at follow-up. More participants were lost follow-up in the MHFA group (51.9%) compared to control (21.4%). Both intention-to-treat (ITT) and non-ITT analyses showed that the MHFA intervention improved mental health first aid intentions (p = first aid actions at follow-up (p = .006). Feedback about the MHFA course was generally positive, with participants stating it helped improve their knowledge and confidence to help someone. This pilot study demonstrated the potential for the MHFA eLearning course to improve UK medical students' mental health first aid skills, confidence to help a friend and stigmatising attitudes. It could be useful in supporting their own and others' mental health while studying and in their future healthcare careers. Retrospectively registered ( ISRCTN11219848 ).

Farewell to the rightist self-employed? 'New self-employment' and political alignments

NARCIS (Netherlands)

Jansen, Giedo

This study aims to provide theoretical and empirical clarity on whether people in “new” and precarious self-employment support the same political parties as those in traditional forms. Theoretical clarity is needed as the voting literature predominantly perceives self-employment in terms of

No effect of forearm band and extensor strengthening exercises for the treatment of tennis elbow: a prospective randomised study.

Science.gov (United States)

Luginbühl, Rolf; Brunner, Florian; Schneeberger, Alberto G

2008-01-01

The objective of this prospective randomised study was to analyse the effect of the forearm support band and of strengthening exercises for the treatment of tennis elbow. Twenty-nine patients with 30 tennis elbows were randomised into 3 groups of treatment: (I) forearm support band, (II) strengthening exercises and (III) both methods. The patients had a standardised examination at their first visit, and then after 6 weeks, 3 months and 1 year. At the latest follow-up, there was a significant improvement of the symptoms compared to before treatment (p<0.0001), considering all patients independently of the methods of treatment. However, no differences in the scores were found between the 3 groups of treatment (p=0.27), indicating that no beneficial influence was found either for the strengthening exercises or for the forearm support band. Improvement seems to occur with time, independent of the method of treatment used.

Employment status, medical support and Income as significant ...

African Journals Online (AJOL)

significant differences in affordability between individuals who had full time paid employment and those who ... Studies have shown that the direct costs of healthcare services2, travel time, patients' income, and ..... and age was their real ages.

Preventing academic difficulties in preterm children: a randomised controlled trial of an adaptive working memory training intervention - IMPRINT study.

Science.gov (United States)

Pascoe, Leona; Roberts, Gehan; Doyle, Lex W; Lee, Katherine J; Thompson, Deanne K; Seal, Marc L; Josev, Elisha K; Nosarti, Chiara; Gathercole, Susan; Anderson, Peter J

2013-09-16

Very preterm children exhibit difficulties in working memory, a key cognitive ability vital to learning information and the development of academic skills. Previous research suggests that an adaptive working memory training intervention (Cogmed) may improve working memory and other cognitive and behavioural domains, although further randomised controlled trials employing long-term outcomes are needed, and with populations at risk for working memory deficits, such as children born preterm.In a cohort of extremely preterm (memory and attention 2 weeks', 12 months' and 24 months' post-intervention, and to investigate training related neuroplasticity in working memory neural networks 2 weeks' post-intervention. This double-blind, placebo-controlled, randomised controlled trial aims to recruit 126 extremely preterm/extremely low birthweight 7-year-old children. Children attending mainstream school without major intellectual, sensory or physical impairments will be eligible. Participating children will undergo an extensive baseline cognitive assessment before being randomised to either an adaptive or placebo (non-adaptive) version of Cogmed. Cogmed is a computerised working memory training program consisting of 25 sessions completed over a 5 to 7 week period. Each training session takes approximately 35 minutes and will be completed in the child's home. Structural, diffusion and functional Magnetic Resonance Imaging, which is optional for participants, will be completed prior to and 2 weeks following the training period. Follow-up assessments focusing on academic skills (primary outcome), working memory and attention (secondary outcomes) will be conducted at 2 weeks', 12 months' and 24 months' post-intervention. To our knowledge, this study will be the first randomised controlled trial to (a) assess the effectiveness of Cogmed in school-aged extremely preterm/extremely low birthweight children, while incorporating advanced imaging techniques to investigate neural changes

Group sequential designs for stepped-wedge cluster randomised trials.

Science.gov (United States)

Grayling, Michael J; Wason, James Ms; Mander, Adrian P

2017-10-01

The stepped-wedge cluster randomised trial design has received substantial attention in recent years. Although various extensions to the original design have been proposed, no guidance is available on the design of stepped-wedge cluster randomised trials with interim analyses. In an individually randomised trial setting, group sequential methods can provide notable efficiency gains and ethical benefits. We address this by discussing how established group sequential methodology can be adapted for stepped-wedge designs. Utilising the error spending approach to group sequential trial design, we detail the assumptions required for the determination of stepped-wedge cluster randomised trials with interim analyses. We consider early stopping for efficacy, futility, or efficacy and futility. We describe first how this can be done for any specified linear mixed model for data analysis. We then focus on one particular commonly utilised model and, using a recently completed stepped-wedge cluster randomised trial, compare the performance of several designs with interim analyses to the classical stepped-wedge design. Finally, the performance of a quantile substitution procedure for dealing with the case of unknown variance is explored. We demonstrate that the incorporation of early stopping in stepped-wedge cluster randomised trial designs could reduce the expected sample size under the null and alternative hypotheses by up to 31% and 22%, respectively, with no cost to the trial's type-I and type-II error rates. The use of restricted error maximum likelihood estimation was found to be more important than quantile substitution for controlling the type-I error rate. The addition of interim analyses into stepped-wedge cluster randomised trials could help guard against time-consuming trials conducted on poor performing treatments and also help expedite the implementation of efficacious treatments. In future, trialists should consider incorporating early stopping of some kind into

An internet-based intervention with brief nurse support to manage obesity in primary care (POWeR+): a pragmatic, parallel-group, randomised controlled trial.

Science.gov (United States)

Little, Paul; Stuart, Beth; Hobbs, Fd Richard; Kelly, Jo; Smith, Emily R; Bradbury, Katherine J; Hughes, Stephanie; Smith, Peter W F; Moore, Michael V; Lean, Mike E J; Margetts, Barrie M; Byrne, Chris D; Griffin, Simon; Davoudianfar, Mina; Hooper, Julie; Yao, Guiqing; Zhu, Shihua; Raftery, James; Yardley, Lucy

2016-10-01

The obesity epidemic has major public health consequences. Expert dietetic and behavioural counselling with intensive follow-up is effective, but resource requirements severely restrict widespread implementation in primary care, where most patients are managed. We aimed to estimate the effectiveness and cost-effectiveness of an internet-based behavioural intervention (POWeR+) combined with brief practice nurse support in primary care. We did this pragmatic, parallel-group, randomised controlled trial at 56 primary care practices in central and south England. Eligible adults aged 18 years or older with a BMI of 30 kg/m(2) or more (or ≥28 kg/m(2) with hypertension, hypercholesterolaemia, or diabetes) registered online with POWeR+-a 24 session, web-based, weight management intervention lasting 6 months. After registration, the website automatically randomly assigned patients (1:1:1), via computer-generated random numbers, to receive evidence-based dietetic advice to swap foods for similar, but healthier, choices and increase fruit and vegetable intake, in addition to 6 monthly nurse follow-up (control group); web-based intervention and face-to-face nurse support (POWeR+Face-to-face [POWeR+F]; up to seven nurse contacts over 6 months); or web-based intervention and remote nurse support (POWeR+Remote [POWeR+R]; up to five emails or brief phone calls over 6 months). Participants and investigators were masked to group allocation at the point of randomisation; masking of participants was not possible after randomisation. The primary outcome was weight loss averaged over 12 months. We did a secondary analysis of weight to measure maintenance of 5% weight loss at months 6 and 12. We modelled the cost-effectiveness of each intervention. We did analysis by intention to treat, with multiple imputation for missing data. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN21244703. Between Jan 30, 2013, and March 20, 2014, 818

Nursing intervention by telephone interviews of patients aged over 65 years after total hip replacement improves health status: a randomised clinical trial Nursing intervention by telephone interviews of patients aged over 65 years after total hip replacement improves health status: a randomised

DEFF Research Database (Denmark)

Hørdam, Britta

2010-01-01

and over by using telephone support and counselling 2 and 10 weeks after surgery compared with a control group receiving conventional care and treatment. Design: A randomised clinical trial focusing on patients' health status by using short-form 36 at 4 weeks preoperatively and 3 and 9 months...... postoperatively was carried out. Sample: 180 patients aged 65 years and over were randomised 4 weeks preoperatively to either control or intervention groups. Measurements: both groups received conventional surgical treatment, but the intervention group was interviewed by telephone 2 and 10 weeks after surgery......Nursing intervention by telephone interviews of patients aged over 65 years after total hip replacement improves health status: a randomised clinical trial Objective: We hypothesised that all areas of health status after total hip replacement could be improved in patients aged over 65 years...

Awareness and behavior of oncologists and support measures in medical institutions related to ongoing employment of cancer patients in Japan.

Science.gov (United States)

Wada, Koji; Ohtsu, Mayumi; Aizawa, Yoshiharu; Tanaka, Hiroshi; Tagaya, Nobumi; Takahashi, Miyako

2012-04-01

Improved outcomes of cancer treatment allow patients to undergo treatment while working. However, support from oncologists and medical institutions is essential for patients to continue working. This study aimed to clarify oncologists' awareness and behavior regarding patients who work during treatment, support in medical institutions and their association. A questionnaire was mailed to all 453 diplomates and faculty of the subspecialty board of medical oncology in the Japanese Society of Medical Oncology and all 1016 surgeons certified by the Japanese Board of Cancer Therapy living in the Kanto area. The questionnaire assessed demographics, oncologist awareness and behavior regarding patient employment and support measures at their medical institutions. Logistic regression analysis was used to examine the association of awareness and behavior of oncologists with support measures at their institutions. A total of 668 individuals participated. The overall response rate was 45.5%. Only 53.6% of respondents advised patients to tell their supervisors about prospects for treatment and ask for understanding. For medical institutions, 28.8% had a nurse-involved counseling program and adjustments in radiation therapy (28.0%) and chemotherapy (41.9%) schedules to accommodate patients' work. There was a significant correlation between awareness and behavior of oncologists and medical institutions' measures to support employed cancer patients. There is room for improvement in awareness and behavior of oncologists and support in medical institutions for cancer patients continuing to work. Oncologists could support working patients by exerting influence on their medical institutions. Conversely, proactive development of support measures by medical institutions could alter the awareness and behavior of oncologists.

Awareness and behavior of oncologists and support measures in medical institutions related to ongoing employment of cancer patients in Japan

International Nuclear Information System (INIS)

Wada, Koji; Aizawa, Yoshiharu; Ohtsu, Mayumi; Tanaka, Hiroshi; Tagaya, Nobumi; Takahashi, Miyako

2012-01-01

Improved outcomes of cancer treatment allow patients to undergo treatment while working. However, support from oncologists and medical institutions is essential for patients to continue working. This study aimed to clarify oncologists' awareness and behavior regarding patients who work during treatment, support in medical institutions and their association. A questionnaire was mailed to all 453 diplomates and faculty of the subspecialty board of medical oncology in the Japanese Society of Medical Oncology and all 1016 surgeons certified by the Japanese Board of Cancer Therapy living in the Kanto area. The questionnaire assessed demographics, oncologist awareness and behavior regarding patient employment and support measures at their medical institutions. Logistic regression analysis was used to examine the association of awareness and behavior of oncologists with support measures at their institutions. A total of 668 individuals participated. The overall response rate was 45.5%. Only 53.6% of respondents advised patients to tell their supervisors about prospects for treatment and ask for understanding. For medical institutions, 28.8% had a nurse-involved counseling program and adjustments in radiation therapy (28.0%) and chemotherapy (41.9%) schedules to accommodate patients' work. There was a significant correlation between awareness and behavior of oncologists and medical institutions' measures to support employed cancer patients. There is room for improvement in awareness and behavior of oncologists and support in medical institutions for cancer patients continuing to work. Oncologists could support working patients by exerting influence on their medical institutions. Conversely, proactive development of support measures by medical institutions could alter the awareness and behavior of oncologists. (author)

INfluence of Successful Periodontal Intervention in REnal Disease (INSPIRED): study protocol for a randomised controlled pilot clinical trial.

Science.gov (United States)

Sharma, Praveen; Cockwell, Paul; Dietrich, Thomas; Ferro, Charles; Ives, Natalie; Chapple, Iain L C

2017-11-13

Patients with chronic kidney disease (CKD) exhibit increased morbidity and mortality which is associated with an increased systemic inflammatory burden. Identifying and managing comorbid diseases that contribute to this load may inform novel care pathways that could have a beneficial impact on the morbidity/mortality associated with CKD. Periodontitis, a highly prevalent, chronic inflammatory disease affecting the supporting structures of teeth, is associated with an increased systemic inflammatory and oxidative stress burden and the successful treatment of periodontitis has been shown to reduce both. This pilot study aims to gather data to inform a definitive study into the impact of successful periodontal treatment on the cardio-renal health of patients with CKD. This pilot study will employ a randomised, controlled, parallel-group design. Sixty adult patients, with CKD with a high risk of progression and with periodontitis, from the Queen Elizabeth Hospital, Birmingham, will be randomised to receive either immediate, intensive periodontal treatment (n = 30) or treatment at a delay of 12 months (n = 30). Patients will be excluded if they have reached end-stage renal disease or have received specialist periodontal treatment in the previous year. Periodontal treatment will be delivered under local anaesthetic, on an outpatient basis, over several visits by a qualified dental hygienist at the Birmingham Dental Hospital, UK. Patients in the delayed-treatment arm will continue to receive the standard community level of periodontal care for a period of 12 months followed by the intensive periodontal treatment. Randomization will occur using a centralised telephone randomisation service, following baseline assessments. The assessor of periodontal health will be blinded to the patients' treatment allocation. Patients in either arm will be followed up at 3-monthly intervals for 18 months. Aside from the pilot outcomes to inform the practicalities of a larger

NHS health checks through general practice: randomised trial of population cardiovascular risk reduction

Directory of Open Access Journals (Sweden)

Cochrane Thomas

2012-11-01

Full Text Available Abstract Background The global burden of the major vascular diseases is projected to rise and to remain the dominant non-communicable disease cluster well into the twenty first century. The Department of Health in England has developed the NHS Health Check service as a policy initiative to reduce population vascular disease risk. The aims of this study were to monitor population changes in cardiovascular disease (CVD risk factors over the first year of the new service and to assess the value of tailored lifestyle support, including motivational interview with ongoing support and referral to other services. Methods Randomised trial comparing NHS Health Check service only with NHS Health Check service plus additional lifestyle support in Stoke on Trent, England. Thirty eight general practices and 601 (365 usual care, 236 additional lifestyle support patients were recruited and randomised independently between September 2009 and February 2010. Changes in population CVD risk between baseline and one year follow-up were compared, using intention-to-treat analysis. The primary outcome was the Framingham 10 year CVD risk score. Secondary outcomes included individual modifiable risk measures and prevalence of individual risk categories. Additional lifestyle support included referral to a lifestyle coach and free sessions as needed for: weight management, physical activity, cook and eat and positive thinking. Results Average population CVD risk decreased from 32.9% to 29.4% (p Conclusions The NHS Health Check service in Stoke on Trent resulted in significant reduction in estimated population CVD risk. There was no evidence of further benefit of the additional lifestyle support services in terms of absolute CVD risk reduction.

Common symptoms in middle aged women: their relation to employment status, psychosocial work conditions and social support in a Swedish setting.

Science.gov (United States)

Krantz, G; Ostergren, P O

2000-03-01

Over the past few decades there has been a growing interest among researchers, in women's overall life circumstances and their relation to women's health status. For example, paid employment has been considered an important part of women's living conditions in Western societies as the number of women entering the labour market has grown constantly over the past decades. When comparing men's and women's health, one of the most consistent findings is a higher rate of symptoms among women. The most commonly reported symptoms in women are depressive symptoms, symptoms of bodily tension and chronic pain from muscles and joints. The aim of this study was to investigate whether socioeconomic factors, employment status, psychosocial work conditions and social network/support are associated with middle aged women's health status in terms of common symptoms. A mailed questionnaire was used in a cross sectional design assessing socioeconomic factors, employment status, psychosocial work conditions according to the demand/control model, social network/support and an index based on the 15 most frequent symptoms presented by middle aged women when seeking health care. A rural community with 13,200 inhabitants in the western part of Sweden. Women were randomly selected from the general population in the study area, 40 to 50 years of age. The response rate was 81.7 per cent. Women who were non-employed had a significantly increased odds of a high level of common symptoms (OR = 2.82; 95% confidence intervals 1.69, 4.70), as well as women exposed to job strain (OR = 3.27; 1.92, 5.57), independently of the level of social network/support. Furthermore, exposure to low social support, low social anchorage or low social participation independently showed significantly increased odds of a high level of common symptoms (OR = 2.75; 1.71, 4.42; OR = 2.91; 1.81, 4.69 and OR = 1.69; 1.10, 2.61, respectively). Work related factors, such as non-employment and job strain, and circumstances

Support and Assessment for Fall Emergency Referrals (SAFER 1: cluster randomised trial of computerised clinical decision support for paramedics.

Directory of Open Access Journals (Sweden)

Helen Anne Snooks

Full Text Available To evaluate effectiveness, safety and cost-effectiveness of Computerised Clinical Decision Support (CCDS for paramedics attending older people who fall.Cluster trial randomised by paramedic; modelling.13 ambulance stations in two UK emergency ambulance services.42 of 409 eligible paramedics, who attended 779 older patients for a reported fall.Intervention paramedics received CCDS on Tablet computers to guide patient care. Control paramedics provided care as usual. One service had already installed electronic data capture.Effectiveness: patients referred to falls service, patient reported quality of life and satisfaction, processes of care.Further emergency contacts or death within one month.Costs and quality of life. We used findings from published Community Falls Prevention Trial to model cost-effectiveness.17 intervention paramedics used CCDS for 54 (12.4% of 436 participants. They referred 42 (9.6% to falls services, compared with 17 (5.0% of 343 participants seen by 19 control paramedics [Odds ratio (OR 2.04, 95% CI 1.12 to 3.72]. No adverse events were related to the intervention. Non-significant differences between groups included: subsequent emergency contacts (34.6% versus 29.1%; OR 1.27, 95% CI 0.93 to 1.72; quality of life (mean SF12 differences: MCS -0.74, 95% CI -2.83 to +1.28; PCS -0.13, 95% CI -1.65 to +1.39 and non-conveyance (42.0% versus 36.7%; OR 1.13, 95% CI 0.84 to 1.52. However ambulance job cycle time was 8.9 minutes longer for intervention patients (95% CI 2.3 to 15.3. Average net cost of implementing CCDS was £208 per patient with existing electronic data capture, and £308 without. Modelling estimated cost per quality-adjusted life-year at £15,000 with existing electronic data capture; and £22,200 without.Intervention paramedics referred twice as many participants to falls services with no difference in safety. CCDS is potentially cost-effective, especially with existing electronic data capture.ISRCTN Register ISRCTN

Maine's Employability Skills Program

Science.gov (United States)

McMahon, John M.; Wolffe, Karen E.; Wolfe, Judy; Brooker, Carrie

2013-01-01

This Practice Report describes the development and implementation of the "Maine Employability Skills Program," a model employment program developed by the Maine Division for the Blind and Visually Impaired (DBVI). The program was designed to support the efforts of the chronically unemployed or underemployed. These consumers were either…

Randomised trial of biofeedback training for encopresis.

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van der Plas, R N; Benninga, M A; Redekop, W K; Taminiau, J A; Büller, H A

1996-01-01

AIMS: To evaluate biofeedback training in children with encopresis and the effect on psychosocial function. DESIGN: Prospective controlled randomised study. PATIENT INTERVENTIONS: A multimodal treatment of six weeks. Children were randomised into two groups. Each group received dietary and toilet advice, enemas, oral laxatives, and anorectal manometry. One group also received five biofeedback training sessions. MAIN OUTCOME MEASURES: Successful treatment was defined as less than two episodes of encopresis, regular bowel movements, and no laxatives. Psychosocial function after treatment was assessed using the Child Behaviour Checklist. RESULTS: Children given laxatives and biofeedback training had higher success rates than those who received laxatives alone (39% v 19%) at the end of the intervention period. At 12 and 18 months, however, approximately 50% of children in each group were successfully treated. Abnormal behaviour scores were initially observed in 35% of children. Most children had improved behaviour scores six months after treatment. Children with an initial abnormal behaviour score who were successfully treated had a significant improvement in their behavioural profiles. CONCLUSIONS: Biofeedback training had no additional effect on the success rate or behaviour scores. Psychosocial problems are present in a subgroup of children with encopresis. The relation between successful treatment and improvement in behavioural function supports the idea that encopresis has an aetiological role in the occurrence and maintenance of behavioural problems in children with encopresis. PMID:8957948

What do working menopausal women want? A qualitative investigation into women's perspectives on employer and line manager support.

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Hardy, Claire; Griffiths, Amanda; Hunter, Myra S

2017-07-01

To explore women's perspectives on what employers and managers should and should not do in relation to women going through the menopause. An online questionnaire was used to collect qualitative data in a cross-sectional study of working women. Three open-ended questions asked peri- and post-menopausal women, aged 45-65 years: (i) what they thought employers could do, or should do, to help menopausal women who may be experiencing difficult menopausal symptoms at work; (ii) how managers should behave; and (iii) how managers should not behave towards women going through the menopause. 137 women responded to the open questions in the survey. An inductive thematic analysis was conducted and three overarching themes emerged. Theme 1 related to employer/manager awareness, specifically to knowledge about the menopause and awareness of how the physical work environment might impact on menopausal women. Theme 2 related to employer/manager communication skills and behaviors, specifically those considered helpful and desired and those considered unhelpful and undesired. Theme 3 described employer actions, involving staff training and raising awareness, and supportive policies such as those relating to sickness absence and flexible working hours. The menopause can be difficult for some women to deal with at work, partly due to the working environment. To our knowledge, this is the first study to explore women's descriptions of how they would like to be treated by employers/managers, and what would be helpful and unhelpful. The results have clear implications for communication about menopause at work and for employer-level policy and practice. Copyright © 2017. Published by Elsevier B.V.

Repetitive transcranial magnetic stimulation for depression after basal ganglia ischaemic stroke: protocol for a multicentre randomised double-blind placebo-controlled trial.

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Tang, Ying; Chen, Aimin; Zhu, Shuzhen; Yang, Li; Zhou, Jiyuan; Pan, Suyue; Shao, Min; Zhao, Lianxu

2018-02-03

Studies suggest that repetitive transcranial magnetic stimulation (rTMS) is effective for the treatment of depression and promotes the repair of white matter. This study aims to assess the effectiveness of rTMS in treating depression after basal ganglia ischaemic stroke and to examine whether such effects are related to restoration of white matter integrity. Sixty-six participants will be recruited from Zhujiang Hospital, Nanfang Hospital and Sichuan Bayi Rehabilitation Hospital and randomised in a 1:1 ratio to receive active rTMS treatment or sham rTMS treatment in addition to routine supportive treatments. The data will be collected at 0, 2 and 4 weeks after the commencement of treatment. The primary outcome is the measurement of 24-item Hamilton Depression Rating Scale scores, and the secondary outcomes include diffusion tensor imaging results and the results of neuropsychological tests including the National Institutes of Health Stroke Scale, Activities of Daily Living Scale, Montreal Cognitive Assessment, Clinical Global Impressions scales, Aphasia Battery in Chinese, Social Support Revalued Scale and Medical Coping Modes Questionnaire. This study has been approved by the Ethics Committee of Zhujiang Hospital of Southern Medical University. The findings will be disseminated by publication in a peer-reviewed journal and by presentation at international conferences. NCT03159351. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The informed consent process in randomised controlled trials: a nurse-led process.

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Cresswell, Pip; Gilmour, Jean

2014-03-01

Clinical trials are carried out with human participants to answer questions about the best way to diagnose, treat and prevent illness. Participants must give informed consent to take part in clinical trials that requires understanding of how clinical trials work and their purpose. Randomised controlled trials provide strong evidence but their complex design is difficult for both clinicians and participants to understand. Increasingly, ensuring informed consent in randomised controlled trials has become part of the clinical research nurse role. The aim of this study was to explore in depth the clinical research nurse role in the informed consent process using a qualitative descriptive approach. Three clinical research nurses were interviewed and data analysed using a thematic analysis approach. Three themes were identified to describe the process of ensuring informed consent. The first theme, Preparatory partnerships, canvassed the relationships required prior to initiation of the informed consent process. The second theme, Partnering the participant, emphasises the need for ensuring voluntariness and understanding, along with patient advocacy. The third theme, Partnership with the project, highlights the clinical research nurse contribution to the capacity of the trial to answer the research question through appropriate recruiting and follow up of participants. Gaining informed consent in randomised controlled trials was complex and required multiple partnerships. A wide variety of skills was used to protect the safety of trial participants and promote quality research. The information from this study contributes to a greater understanding of the clinical research nurse role, and suggests the informed consent process in trials can be a nurse-led one. In order to gain collegial, employer and industry recognition it is important this aspect of the nursing role is acknowledged.

The role of social support in protecting mental health when employed and unemployed: A longitudinal fixed-effects analysis using 12 annual waves of the HILDA cohort.

Science.gov (United States)

Milner, Allison; Krnjacki, Lauren; Butterworth, Peter; LaMontagne, Anthony D

2016-03-01

Perceived social support is associated with overall better mental health. There is also evidence that unemployed workers with higher social support cope better psychologically than those without such support. However, there has been limited research about the effect of social support among people who have experienced both unemployment and employment. We assessed this topic using 12 years of annually collected cohort data. The sample included 3190 people who had experienced both unemployment and employment. We used longitudinal fixed-effects modelling to investigate within-person changes in mental health comparing the role of social support when a person was unemployed to when they were employed. Compared to when a person reported low social support, a change to medium (6.35, 95% 5.66 to 7.04, p social support (11.58, 95%, 95% CI 10.81 to 12.36, p health (measured on an 100 point scale, with higher scores representing better mental health). When a person was unemployed but had high levels of social support, their mental health was 2.89 points (95% CI 1.67 to 4.11, p social support. The buffering effect of social support was confirmed in stratified analysis. There was a strong direct effect of social support on mental health. The magnitude of these differences could be considered clinically meaningful. Our results also suggest that social support has a significant buffering effect on mental health when a person is unemployed. Copyright © 2016 Elsevier Ltd. All rights reserved.

Influence of employer support for professional development on MOOCs enrolment and comple-tion: Results from a cross-course survey

NARCIS (Netherlands)

Castaño-Muñoz, Jonatan; Kalz, Marco; Kreijns, Karel; Punie, Yves

2018-01-01

Although the potential of open education and MOOCs for professional development is usually recognized, it has not yet been explored extensively. How far employers support non-formal learning is still an open question. This paper presents the findings of a survey-based study which focuses on the

Employment and Growth | IDRC - International Development ...

International Development Research Centre (IDRC) Digital Library (Canada)

Our investments increase employment and economic opportunities for women and youth. ... The Employment and Growth program seeks to enhance the employment and economic opportunities of ... The untold story: IDRC supported researchers transform economic policy in Africa ... Careers · Contact Us · Site map.

Pre-post, mixed-methods feasibility study of the WorkingWell mobile support tool for individuals with serious mental illness in the USA: a pilot study protocol.

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Nicholson, Joanne; Wright, Spenser M; Carlisle, Alyssa M

2018-02-06

Successful competitive employment has been found to be related to enhanced self-esteem, higher quality of life and reduced mental health service use for individuals living with serious mental illnesses (SMIs) including schizophrenia, bipolar disorder and major depression. The effectiveness of the individual placement and support model has been demonstrated in multiple randomised controlled trials in many countries. The management of stress, depression and anxiety in the workplace may be effectively enhanced through digital mental health interventions. The WorkingWell mobile support tool ('app') is specifically designed to meet the need for illness management support for individuals with SMI in the workplace, as an adjunct to professional treatment. The WorkingWell app, grounded in evidence-based supported employment, is informed by user experience design. It will be tested in a pre-post design, mixed-methods pilot study to explore issues of feasibility, acceptability and usefulness, and to provide preliminary data on the impact of use. Putative mediators of improved job tenure and psychological well-being, including postintervention changes in social support, self-efficacy and work-related motivation, will be investigated. Forty individuals at least 18 years of age, meeting the eligibility requirements for supported employment services (ie, diagnosed with a mental illness meeting the criteria for severity, duration and treatment), working a minimum of 10 hours per week at study enrolment, and speaking, reading and writing in English will be recruited for the pilot study. Research staff will recruit individuals at community-based mental health agencies; provide orientation to the study, the study smartphones and the WorkingWell app; conduct research interviews including standardised measures as well as semistructured items; and provide technical assistance in telephone calls and inperson meetings. A sample of 10 agency staff will be recruited to obtain further

Randomised clinical trial

DEFF Research Database (Denmark)

Reimer, C; Lødrup, A; Smith, G

2016-01-01

of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. MethodsThis was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using...

Perceptions of Supported Employment Providers: What Students with Developmental Disabilities, Families, and Educators Need to Know for Transition Planning

Science.gov (United States)

Moon, Sherril; Simonsen, Monica L.; Neubert, Debra A.

2011-01-01

The purpose of this exploratory study was to survey community rehabilitation providers (CRPs) to determine their perceptions of the skills, experiences, and information that transitioning youth with developmental disabilities (DD) and their families need to access supported employment (SE) services. Supervisors of SE from 12 CRPs across one state…

Moxibustion for cephalic version: a feasibility randomised controlled trial

Directory of Open Access Journals (Sweden)

Bisits Andrew

2011-09-01

Full Text Available Abstract Background Moxibustion (a type of Chinese medicine which involves burning a herb close to the skin has been used to correct a breech presentation. Evidence of effectiveness and safety from systematic reviews is encouraging although significant heterogeneity has been found among trials. We assessed the feasibility of conducting a randomised controlled trial of moxibustion plus usual care compared with usual care to promote cephalic version in women with a breech presentation, and examined the views of women and health care providers towards implementing a trial within an Australian context. Methods The study was undertaken at a public hospital in Newcastle, New South Wales, Australia. Women at 34-36.5 weeks of gestation with a singleton breech presentation (confirmed by ultrasound, were randomised to moxibustion plus usual care or usual care alone. The intervention was administered over 10 days. Clinical outcomes included cephalic presentation at birth, the need for ECV, mode of birth; perinatal morbidity and mortality, and maternal complications. Feasibility outcomes included: recruitment rate, acceptability, compliance and a sample size for a future study. Interviews were conducted with 19 midwives and obstetricians to examine the acceptability of moxibustion, and views on the trial. Results Twenty women were randomised to the trial. Fifty one percent of women approached accepted randomisation to the trial. A trend towards an increase in cephalic version at delivery (RR 5.0; 95% CI 0.7-35.5 was found for women receiving moxibustion compared with usual care. There was also a trend towards greater success with version following ECV. Two babies were admitted to the neonatal unit from the moxibustion group. Compliance with the moxibustion protocol was acceptable with no reported side effects. Clinicians expressed the need for research to establish the safety and efficacy of moxibustion, and support for the intervention was given to

Effects of an Employer-Based Intervention on Employment Outcomes for Youth with Significant Support Needs Due to Autism

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Wehman, Paul; Schall, Carol M.; McDonough, Jennifer; Graham, Carolyn; Brooke, Valerie; Riehle, J. Erin; Brooke, Alissa; Ham, Whitney; Lau, Stephanie; Allen, Jaclyn; Avellone, Lauren

2017-01-01

The purpose of this study was to develop and investigate an employer-based 9-month intervention for high school youth with autism spectrum disorder to learn job skills and acquire employment. The intervention modified a program titled Project SEARCH and incorporated the use of applied behavior analysis to develop Project SEARCH plus Autism…

A cluster randomised controlled trial of the Wellbeing in Secondary Education (WISE) Project - an intervention to improve the mental health support and training available to secondary school teachers: protocol for an integrated process evaluation.

Science.gov (United States)

Evans, Rhiannon; Brockman, Rowan; Grey, Jillian; Bell, Sarah; Harding, Sarah; Gunnell, David; Campbell, Rona; Murphy, Simon; Ford, Tamsin; Hollingworth, William; Tilling, Kate; Morris, Richard; Kadir, Bryar; Araya, Ricardo; Kidger, Judi

2018-05-04

Secondary school teachers have low levels of wellbeing and high levels of depression compared with the general population. Teachers are in a key position to support students, but poor mental health may be a barrier to doing so effectively. The Wellbeing in Secondary Education (WISE) project is a cluster randomised controlled trial (RCT) of an intervention to improve the mental health support and training available to secondary school teachers through delivery of the training package Mental Health First Aid and a staff peer support service. We will conduct a process evaluation as part of the WISE trial to support the interpretation of trial outcomes and refine intervention theory. The domains assessed will be: the extent to which the hypothesised mechanisms of change are activated; system level influences on these mechanisms; programme differentiation and usual practice; intervention implementation, including any adaptations; intervention acceptability; and intervention sustainability. Research questions will be addressed via quantitative and qualitative methods. All study schools (n = 25) will provide process evaluation data, with more detailed focus group, interview and observation data being collected from a subsample of case study schools (4 intervention and 4 control). Mechanisms of change, as outlined in a logic model, will be measured via teacher and student surveys and focus groups. School context will be explored via audits of school practice that relate to mental health and wellbeing, combined with stakeholder interviews and focus groups. Implementation of the training and peer support service will be assessed via training observations, training participant evaluation forms, focus groups with participants, interviews with trainers and peer support service users, and peer supporter logs recording help provided. Acceptability and sustainability will be examined via interviews with funders, head teachers, trainers and peer support services users, and

Mendelian Randomisation Studies Do Not Support a Causal Role for Reduced Circulating Adiponectin Levels in Insulin Resistance and Type 2 Diabetes

DEFF Research Database (Denmark)

Yaghootkar, Hanieh; Lamina, Claudia; Scott, Robert A

2013-01-01

Adiponectin is strongly inversely associated with insulin resistance and type 2 diabetes but its causal role remains controversial. We used a Mendelian randomisation approach to test the hypothesis that adiponectin causally influences insulin resistance and type 2 diabetes. We used genetic varian...

Waste the waist: a pilot randomised controlled trial of a primary care based intervention to support lifestyle change in people with high cardiovascular risk.

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Greaves, Colin; Gillison, Fiona; Stathi, Afroditi; Bennett, Paul; Reddy, Prasuna; Dunbar, James; Perry, Rachel; Messom, Daniel; Chandler, Roger; Francis, Margaret; Davis, Mark; Green, Colin; Evans, Philip; Taylor, Gordon

2015-01-16

In the UK, thousands of people with high cardiovascular risk are being identified by a national risk-assessment programme (NHS Health Checks). Waste the Waist is an evidence-informed, theory-driven (modified Health Action Process Approach), group-based intervention designed to promote healthy eating and physical activity for people with high cardiovascular risk. This pilot randomised controlled trial aimed to assess the feasibility of delivering the Waste the Waist intervention in UK primary care and of conducting a full-scale randomised controlled trial. We also conducted exploratory analyses of changes in weight. Patients aged 40-74 with a Body Mass Index of 28 or more and high cardiovascular risk were identified from risk-assessment data or from practice database searches. Participants were randomised, using an online computerised randomisation algorithm, to receive usual care and standardised information on cardiovascular risk and lifestyle (Controls) or nine sessions of the Waste the Waist programme (Intervention). Group allocation was concealed until the point of randomisation. Thereafter, the statistician, but not participants or data collectors were blinded to group allocation. Weight, physical activity (accelerometry) and cardiovascular risk markers (blood tests) were measured at 0, 4 and 12 months. 108 participants (22% of those approached) were recruited (55 intervention, 53 controls) from 6 practices and 89% provided data at both 4 and 12 months. Participants had a mean age of 65 and 70% were male. Intervention participants attended 72% of group sessions. Based on last observations carried forward, the intervention group did not lose significantly more weight than controls at 12 months, although the difference was significant when co-interventions and co-morbidities that could affect weight were taken into account (Mean Diff 2.6Kg. 95%CI: -4.8 to -0.3, p = 0.025). No significant differences were found in physical activity. The Waste the Waist

A healthy school start - Parental support to promote healthy dietary habits and physical activity in children: Design and evaluation of a cluster-randomised intervention

Directory of Open Access Journals (Sweden)

Elinder Liselotte

2011-03-01

Full Text Available Abstract Background Childhood obesity is multi-factorial and determined to a large extent by dietary habits, physical activity and sedentary behaviours. Previous research has shown that school-based programmes are effective but that their effectiveness can be improved by including a parental component. At present, there is a lack of effective parental support programmes for improvement of diet and physical activity and prevention of obesity in children. Methods/Design This paper describes the rationale and design of a parental support programme to promote healthy dietary habits and physical activity in six-year-old children starting school. The study is performed in close collaboration with the school health care and is designed as a cluster-randomised controlled trial with a mixed methods approach. In total, 14 pre-school classes are included from a municipality in Stockholm county where there is large variation in socio-economic status between the families. The school classes are randomised to intervention (n = 7 and control (n = 7 groups including a total of 242 children. The intervention is based on social cognitive theory and consists of three main components: 1 a health information brochure; 2 two motivational interviewing sessions with the parents; and 3 teacher-led classroom activities with the children. The primary outcomes are physical activity in the children measured objectively by accelerometry, children's dietary and physical activity habits measured with a parent-proxy questionnaire and parents' self-efficacy measured by a questionnaire. Secondary outcomes are height, weight and waist circumference in the children. The duration of the intervention is six months and includes baseline, post intervention and six months follow-up measurements. Linear and logistic regression models will be used to analyse differences between intervention and control groups in the outcome variables. Mediator and moderator analysis will be performed

Efficacy of a text messaging (SMS) based intervention for adults with hypertension: protocol for the StAR (SMS Text-message Adherence suppoRt trial) randomised controlled trial.

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Bobrow, Kirsty; Brennan, Thomas; Springer, David; Levitt, Naomi S; Rayner, Brian; Namane, Mosedi; Yu, Ly-Mee; Tarassenko, Lionel; Farmer, Andrew

2014-01-11

Interventions to support people with hypertension in attending clinics and taking their medication have potential to improve outcomes, but delivery on a wide scale and at low cost is challenging. Some trials evaluating clinical interventions using short message service (SMS) text-messaging systems have shown important outcomes, although evidence is limited. We have developed a novel SMS system integrated with clinical care for use by people with hypertension in a low-resource setting. We aim to test the efficacy of the system in improving blood pressure control and treatment adherence compared to usual care. The SMS Text-message Adherence suppoRt trial (StAR) is a pragmatic individually randomised three-arm parallel group trial in adults treated for hypertension at a single primary care centre in Cape Town, South Africa. The intervention is a structured programme of clinic appointment, medication pick-up reminders, medication adherence support and hypertension-related education delivered remotely using an automated system with either informational or interactive SMS text-messages. Usual care is supplemented by infrequent non-hypertension related SMS text-messages. Participants are 1:1:1 individually randomised, to usual care or to one of the two active interventions using minimisation to dynamically adjust for gender, age, baseline systolic blood pressure, years with hypertension, and previous clinic attendance. The primary outcome is the change in mean systolic blood pressure at 12-month follow-up from baseline measured with research staff blinded to trial allocation. Secondary outcomes include the proportion of patients with 80% or more of days medication available, proportion of participants achieving a systolic blood pressure less than 140 mmHg and a diastolic blood pressure less than 90 mmHg, hospital admissions, health status, retention in clinical care, satisfaction with treatment and care, and patient related quality of life. Anonymised demographic data

Job strain and psychological distress among employed pregnant Thai women: role of social support and coping strategies.

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Sanguanklin, Natthananporn; McFarlin, Barbara L; Finnegan, Lorna; Park, Chang Gi; Giurgescu, Carmen; White-Traut, Rosemary; Engstrom, Janet L

2014-08-01

Most Thai women continue to work throughout their pregnancy; however, little is known about job strain and its relation to psychological distress. This study aimed to examine: (1) the direct effects of job strain, perceived workplace support, perceived family support, and coping strategies on psychological distress and (2) the moderating effect of perceived workplace support, perceived family support, and coping strategies on the relationship between job strain and psychological distress. Lazarus and Folkman's transactional model of stress and coping guided this cross-sectional study. Full-time employed pregnant women (N = 300) were recruited from three antenatal clinics in Thailand. Thai versions of the following instruments were used: the State-Anxiety Inventory and Center for Epidemiological Studies-Depression Scale (psychological distress), the Job Content Questionnaire (job strain and perceived workplace support), the Medical Outcome Study Social Support Survey (perceived family support), and the Ways of Coping Checklist-Revised (coping strategies). Job strain with other predictors explained 54% of the variance in psychological distress. In the separate hierarchical multiple linear regression models, two types of coping strategies, seeking social support and wishful thinking, moderated the effects of job strain on psychological distress. Perceived family support had a direct effect in reducing psychological distress. Job strain is a significant contributor to psychological distress. The average levels of seeking social support and wishful thinking were most beneficial in moderating the negative impact of job strain on psychological distress. Since perceived workplace and family support did not have moderating effects, stress management programs for decreasing the levels of job strain should be developed.

Early retirement and non-employment after breast cancer.

Science.gov (United States)

Lindbohm, M-L; Kuosma, E; Taskila, T; Hietanen, P; Carlsen, K; Gudbergsson, S; Gunnarsdottir, H

2014-06-01

This study examined whether workplace support, sociodemographic factors and co-morbidity are associated with early retirement or non-employment due to other reasons among breast cancer survivors. We also compared quality of life and chronic symptoms (pain, fatigue, anxiety and depression) among employed, retired and other non-employed breast cancer survivors. We identified breast cancer survivors diagnosed between 1997 and 2002 from either a hospital or a cancer registry in Denmark, Finland, Iceland and Norway (NOCWO study). All patients had been treated with curative intent. Information on employment, co-morbidity and support was collected via a questionnaire. The sample included 1111 working-aged cancer-free survivors who had been employed at the time of diagnosis. We used multinomial logistic regression models to analyse the association of various determinants with early retirement and other non-employment (due to unemployment, subsidized employment or being a homemaker). Low education, low physical quality of life, co-morbidity and pain were associated with both early retirement and other non-employment after cancer. Other non-employed survivors also rated their mental quality of life as lower and experienced anxiety and fatigue more often than all the other survivors. Moreover, they reported a lower level of supervisor support after their diagnosis than the employed survivors. Retired survivors more often reported weak support from colleagues. Differences in ill health and functional status between various groups of non-employed cancer survivors need to be considered when planning policy measures for improving the labour market participation of this population and preventing their early withdrawal from working life. Copyright © 2013 John Wiley & Sons, Ltd.

Protocol for the SEED-trial: Supported Employment and preventing Early Disability.

Science.gov (United States)

Sveinsdottir, Vigdis; Tveito, Torill Helene; Bond, Gary R; Grasdal, Astrid Louise; Lie, Stein Atle; Reme, Silje Endresen

2016-07-15

Early withdrawal or exclusion from the labor market leads to significant personal and societal costs. In Norway, the increasing numbers of young adults receiving disability pension is a growing problem. While a large body of research demonstrates positive effects of Supported Employment (SE) in patients with severe mental illness, no studies have yet investigated the effectiveness of SE in young adults with a range of social and health conditions who are receiving benefits. The SEED-trial is a randomized controlled trial (RCT) comparing traditional vocational rehabilitation (TVR) to SE in 124 unemployed individuals between the ages of 18-29 who are receiving benefits due to various social- or health-related problems. The primary outcome is labor market participation during the first year after enrollment. Secondary outcomes include physical and mental health, health behaviors, and well-being, collected at baseline, 6, and 12 months. A cost-benefit analysis will also be conducted. The SEED-trial is the first RCT to compare SE to TVR in this important and vulnerable group, at risk of being excluded from working life at an early age. Clinicaltrials.gov, registration number NCT02375074 . Registered on December 3rd 2014.

Ethical implications of excessive cluster sizes in cluster randomised trials.

Science.gov (United States)

Hemming, Karla; Taljaard, Monica; Forbes, Gordon; Eldridge, Sandra M; Weijer, Charles

2018-02-20

The cluster randomised trial (CRT) is commonly used in healthcare research. It is the gold-standard study design for evaluating healthcare policy interventions. A key characteristic of this design is that as more participants are included, in a fixed number of clusters, the increase in achievable power will level off. CRTs with cluster sizes that exceed the point of levelling-off will have excessive numbers of participants, even if they do not achieve nominal levels of power. Excessively large cluster sizes may have ethical implications due to exposing trial participants unnecessarily to the burdens of both participating in the trial and the potential risks of harm associated with the intervention. We explore these issues through the use of two case studies. Where data are routinely collected, available at minimum cost and the intervention poses low risk, the ethical implications of excessively large cluster sizes are likely to be low (case study 1). However, to maximise the social benefit of the study, identification of excessive cluster sizes can allow for prespecified and fully powered secondary analyses. In the second case study, while there is no burden through trial participation (because the outcome data are routinely collected and non-identifiable), the intervention might be considered to pose some indirect risk to patients and risks to the healthcare workers. In this case study it is therefore important that the inclusion of excessively large cluster sizes is justifiable on other grounds (perhaps to show sustainability). In any randomised controlled trial, including evaluations of health policy interventions, it is important to minimise the burdens and risks to participants. Funders, researchers and research ethics committees should be aware of the ethical issues of excessively large cluster sizes in cluster trials. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is

Career-building support for research on employment and growth ...

International Development Research Centre (IDRC) Digital Library (Canada)

2017-12-18

Dec 18, 2017 ... Their Policy Analysis on Growth and Employment (PAGE) program takes ... Many organizations, many people approached us to try to get the results ... prevention among the "choice disabled" — vulnerable groups less able to ...

Prophylactic platelet transfusion plus supportive care versus supportive care alone in adults with dengue and thrombocytopenia: a multicentre, open-label, randomised, superiority trial.

Science.gov (United States)

Lye, David C; Archuleta, Sophia; Syed-Omar, Sharifah F; Low, Jenny G; Oh, Helen M; Wei, Yuan; Fisher, Dale; Ponnampalavanar, Sasheela S L; Wijaya, Limin; Lee, Linda K; Ooi, Eng-Eong; Kamarulzaman, Adeeba; Lum, Lucy C; Tambyah, Paul A; Leo, Yee-Sin

2017-04-22

Dengue is the commonest vector-borne infection worldwide. It is often associated with thrombocytopenia, and prophylactic platelet transfusion is widely used despite the dearth of robust evidence. We aimed to assess the efficacy and safety of prophylactic platelet transfusion in the prevention of bleeding in adults with dengue and thrombocytopenia. We did an open-label, randomised, superiority trial in five hospitals in Singapore and Malaysia. We recruited patients aged at least 21 years who had laboratory-confirmed dengue (confirmed or probable) and thrombocytopenia (≤20 000 platelets per μL), without persistent mild bleeding or any severe bleeding. Patients were assigned (1:1), with randomly permuted block sizes of four or six and stratified by centre, to receive prophylactic platelet transfusion in addition to supportive care (transfusion group) or supportive care alone (control group). In the transfusion group, 4 units of pooled platelets were given each day when platelet count was 20 000 per μL or lower; supportive care consisted of bed rest, fluid therapy, and fever and pain medications. The primary endpoint was clinical bleeding (excluding petechiae) by study day 7 or hospital discharge (whichever was earlier), analysed by intention to treat. Safety outcomes were analysed according to the actual treatment received. This study was registered with ClinicalTrials.gov, number NCT01030211, and is completed. Between April 29, 2010, and Dec 9, 2014, we randomly assigned 372 patients to the transfusion group (n=188) or the control group (n=184). The intention-to-treat analysis included 187 patients in the transfusion group (one patient was withdrawn immediately) and 182 in the control group (one was withdrawn immediately and one did not have confirmed or probable dengue). Clinical bleeding by day 7 or hospital discharge occurred in 40 (21%) patients in the transfusion group and 48 (26%) patients in the control group (risk difference -4·98% [95% CI -15·08 to

Analysis Of Supporting Factors On Foreign Direct Investment And Its Impact Toward Indonesian Employment And Export Performance Period 2005-2015

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Suharto

2017-09-01

Full Text Available This research analyzes effects of foreign direct investment and Its Impact toward employment and export performance in Indonesia 2005-2015. This research with secondary data focuses on the Supporting factors in which attract foreign direct investment into Indonesia. This research focused on the problem First the impact of labor export results economic growth rate exchange rate inflation rate interest rate and tax toward foreign direct investment second the impact of foreign direct investment on the expansion of employment and export performance in Indonesia during the period 2005-2015. The result of this research explains that variables of human resourceslabor and export performance give positive effect as significantly to attracting foreign direct investment in Indonesia. While foreign direct investment in Indonesia gives positive effect to employment creation and to export performance.

Sustained employability of workers in a production environment: design of a stepped wedge trial to evaluate effectiveness and cost-benefit of the POSE program.

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van Holland, Berry J; de Boer, Michiel R; Brouwer, Sandra; Soer, Remko; Reneman, Michiel F

2012-11-20

Sustained employability and health are generating awareness of employers in an aging and more complex work force. To meet these needs, employers may offer their employees health surveillance programs, to increase opportunities to work on health and sustained employability. However, evidence for these health surveillance programs is lacking. The FLESH study (Functional Labour Evaluation for Sustained Health and employment) was developed to evaluate a comprehensive workers' health promotion program on its effectiveness, cost-benefit, and process of the intervention. The study is designed as a cluster randomised stepped wedge trial with randomisation at company plant level and is carried out in a large meat processing company. Every contracted employee is offered the opportunity to participate in the POSE program (Promotion Of Sustained Employability). The main goals of the POSE program are 1) providing employee's insight into their current employability and health status, 2) offering opportunities to improve employability and decrease health risks and 3) improving employability and health sustainably in order to keep them healthy at work. The program consists of a broad assessment followed by a counselling session and, if needed, a tailored intervention. Measurements will be performed at baseline and will be followed up at 20, 40, 60, 80, 106 and 132 weeks. The primary outcome measures are work ability, productivity and absenteeism. Secondary outcomes include health status, vitality, and psychosocial workload. A cost-benefit study will be conducted from the employers' perspective. A process evaluation will be conducted and the satisfaction of employer and employees with the program will be assessed. This study provides information on the effectiveness of the POSE program on sustained employment. When the program proves to be effective, employees benefit by improved work ability, and health. Employers benefit from healthier employees, reduced sick leave (costs) and

Getting better at chronic care in remote communities: study protocol for a pragmatic cluster randomised controlled of community based management.

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Schmidt, Barbara; Wenitong, Mark; Esterman, Adrian; Hoy, Wendy; Segal, Leonie; Taylor, Sean; Preece, Cilla; Sticpewich, Alex; McDermott, Robyn

2012-11-21

Prevalence and incidence of diabetes and other common comorbid conditions (hypertension, coronary heart disease, renal disease and chronic lung disease) are extremely high among Indigenous Australians. Recent measures to improve quality of preventive care in Indigenous community settings, while apparently successful at increasing screening and routine check-up rates, have shown only modest or little improvements in appropriate care such as the introduction of insulin and other scaled-up drug regimens in line with evidence-based guidelines, together with support for risk factor reduction. A new strategy is required to ensure high quality integrated family-centred care is available locally, with continuity and cultural safety, by community-based care coordinators with appropriate system supports. The trial design is open parallel cluster randomised controlled trial. The objective of this pragmatic trial is to test the effectiveness of a model of health service delivery that facilitates integrated community-based, intensive chronic condition management, compared with usual care, in rural and remote Indigenous primary health care services in north Queensland. Participants are Indigenous adults (aged 18-65 years) with poorly controlled diabetes (HbA1c>=8.5) and at least one other chronic condition. The intervention is to employ an Indigenous Health Worker to case manage the care of a maximum caseload of 30 participants. The Indigenous Health Workers receive intensive clinical training initially, and throughout the study, to ensure they are competent to coordinate care for people with chronic conditions. The Indigenous Health Workers, supported by the local primary health care (PHC) team and an Indigenous Clinical Support Team, will manage care, including coordinating access to multidisciplinary team care based on best practice standards. Allocation by cluster to the intervention and control groups is by simple randomisation after participant enrolment. Participants in

Supported employment among veterans with serious mental illness: the role of cognition and social cognition on work outcome

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L. Felice Reddy

2014-09-01

Full Text Available Unemployment is a primary functional deficit for the majority of adults with schizophrenia. Research indicates that over two-thirds of adults living in the community with schizophrenia are unemployed. Despite effective programs to assist with job identification and placement, the ability to attain and maintain employment remains a pressing concern. Neurocognitive functioning is widely acknowledged to be a determinant of work outcome; however, effect sizes tend to be in the small to medium range. The present study sought to further understand the determinants of work outcome among a sample of 104 veterans with schizophrenia enrolled in a supported employment program. A small percentage of veterans in the study got competitive jobs; 53% who secured jobs maintained employment for longer than 6 months. Cognition, social cognition, and symptoms were unrelated to job attainment. However, speed of processing and social cognition were significant predictors of work outcomes such as wages and tenure. These findings suggest that cognitive abilities including processing speed and the ability to accurately interpret and respond to social cues are significant determinants of whether individuals with schizophrenia remain employed. The results are discussed in light of current available treatment options and domains to target in synergy with work rehabilitation efforts.

Supported housing for people with severe mental disorders.

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Chilvers, R; Macdonald, G M; Hayes, A A

2006-10-18

There has been a significant reduction in the number of people with severe mental illness who spend extended periods in long-stay hospitals. District health authorities, local authorities, housing associations and voluntary organisations are jointly expected to provide support for people with severe mental disorder/s. This 'support' may well involve some kind of special housing. To determine the effects of supported housing schemes compared with outreach support schemes or 'standard care' for people with severe mental disorder/s living in the community. For the 2006 update we searched the Cochrane Schizophrenia Group Trials Register (April 2006) and the Cochrane Central Register of Controlled Trials (CENTRAL, 2006 Issue 2). We included all relevant randomised, or quasi-randomised, trials dealing with people with 'severe mental disorder/s' allocated to supported housing, compared with outreach support schemes or standard care. We focused on outcomes of service utilisation, mental state, satisfaction with care, social functioning, quality of life and economic data. We reliably selected studies, quality rated them and undertook data extraction. For dichotomous data, we would have estimated relative risks (RR), with the 95% confidence intervals (CI). Where possible, we would have calculated the number needed to treat statistic (NNT). We would have carried out analysis by intention-to-treat and would have summated normal continuous data using the weighted mean difference (WMD). We would have presented scale data for only those tools that had attained pre-specified levels of quality and undertaken tests for heterogeneity and publication bias. Although 139 citations were acquired from the searches, no study met the inclusion criteria. Dedicated schemes whereby people with severe mental illness are located within one site or building with assistance from professional workers have potential for great benefit as they provide a 'safe haven' for people in need of stability and

Employers' experience of employees with cancer: trajectories of complex communication.

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Tiedtke, C M; Dierckx de Casterlé, B; Frings-Dresen, M H W; De Boer, A G E M; Greidanus, M A; Tamminga, S J; De Rijk, A E

2017-10-01

Remaining in paid work is of great importance for cancer survivors, and employers play a crucial role in achieving this. Return to work (RTW) is best seen as a process. This study aims to provide insight into (1) Dutch employers' experiences with RTW of employees with cancer and (2) the employers' needs for support regarding this process. Thirty employer representatives of medium and large for-profit and non-profit organizations were interviewed to investigate their experiences and needs in relation to employees with cancer. A Grounded Theory approach was used. We revealed a trajectory of complex communication and decision-making during different stages, from the moment the employee disclosed that they had been diagnosed to the period after RTW, permanent disability, or the employee's passing away. Employers found this process demanding due to various dilemmas. Dealing with an unfavorable diagnosis and balancing both the employer's and the employee's interests were found to be challenging. Two types of approach to support RTW of employees with cancer were distinguished: (1) a business-oriented approach and (2) a care-oriented approach. Differences in approach were related to differences in organizational structure and employer and employee characteristics. Employers expressed a need for communication skills, information, and decision-making skills to support employees with cancer. The employers interviewed stated that dealing with an employee with cancer is demanding and that the extensive Dutch legislation on RTW did not offer all the support needed. We recommend providing them with easily accessible information on communication and leadership training to better support employees with cancer. • Supporting employers by training communication and decision-making skills and providing information on cancer will contribute to improving RTW support for employees with cancer. • Knowing that the employer will usually be empathic when an employee reveals that they have

Study protocol: ICONS: Identifying continence options after stroke: A randomised trial

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Leathley Michael J

2011-05-01

Full Text Available Abstract Background Urinary incontinence following acute stroke is common, affecting between 40%-60% of people in hospital after a stroke. Despite the availability of clinical guidelines for urinary incontinence and urinary incontinence after stroke, national audit data suggest incontinence is often poorly managed. Conservative interventions (e.g. bladder training, pelvic floor muscle training and prompted voiding have been shown to have some effect with participants in Cochrane systematic reviews, but have not had their effectiveness demonstrated with stroke patients. Methods/Design A cluster randomised controlled pilot trial designed to assess the feasibility of a full-scale cluster randomised trial and to provide preliminary evidence of the effectiveness and cost-effectiveness of a systematic voiding programme for the management of continence after stroke. Stroke services will be randomised to receive the systematic voiding programme, the systematic voiding programme plus supported implementation, or usual care. The trial aims to recruit at least 780 participants in 12 stroke services (4 per arm. The primary outcome is presence/absence of incontinence at six weeks post-stroke. Secondary outcomes include frequency and severity of incontinence, quality of life and cost-utility. Outcomes will be measured at six weeks, three months and (for participants recruited in the first three months twelve months after stroke. Process data will include rates of recruitment and retention and fidelity of intervention delivery. An integrated qualitative evaluation will be conducted in order to describe implementation and assist in explaining the potential mediators and modifiers of the process. Trial Registration ISRCTN: ISRCTN08609907

Evaluating the Benefits of Aphasia Intervention Delivered in Virtual Reality: Results of a Quasi-Randomised Study.

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Marshall, Jane; Booth, Tracey; Devane, Niamh; Galliers, Julia; Greenwood, Helen; Hilari, Katerina; Talbot, Richard; Wilson, Stephanie; Woolf, Celia

2016-01-01

This study evaluated an intervention for people with aphasia delivered in a novel virtual reality platform called EVA Park. EVA Park contains a number of functional and fantastic locations and allows for interactive communication between multiple users. Twenty people with aphasia had 5 weeks' intervention, during which they received daily language stimulation sessions in EVA Park from a support worker. The study employed a quasi randomised design, which compared a group that received immediate intervention with a waitlist control group. Outcome measures explored the effects of intervention on communication and language skills, communicative confidence and feelings of social isolation. Compliance with the intervention was also explored through attrition and usage data. There was excellent compliance with the intervention, with no participants lost to follow up and most (18/20) receiving at least 88% of the intended treatment dose. Intervention brought about significant gains on a measure of functional communication. Gains were achieved by both groups of participants, once intervention was received, and were well maintained. Changes on the measures of communicative confidence and feelings of social isolation were not achieved. Results are discussed with reference to previous aphasia therapy findings.

Randomised clinical trial: enteral nutrition does not improve the long-term outcome of alcoholic cirrhotic patients with jaundice.

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Dupont, B; Dao, T; Joubert, C; Dupont-Lucas, C; Gloro, R; Nguyen-Khac, E; Beaujard, E; Mathurin, P; Vastel, E; Musikas, M; Ollivier, I; Piquet, M-A

2012-05-01

Malnutrition and jaundice are independent prognostic factors in cirrhosis. To assess the impact of enteral nutrition on the survival of alcoholic cirrhotic patients with jaundice but without acute alcoholic hepatitis. The study was a multicentre prospective randomised controlled trial comparing effects of enteral nutrition vs. a symptomatic support in patients with alcoholic cirrhosis and jaundice (bilirubin ≥51 µmol/L) but without severe acute alcoholic hepatitis. A total of 99 patients were randomised to receive either the conventional symptomatic treatment (55 patients) or the symptomatic support associated with 35 kcal/Kg/day of enteral nutrition during 4 weeks followed by an oral nutritional support during 2 months (44 patients). Randomisation was stratified on nutritional status. One-year survival curves were compared using the Kaplan-Meier method and Logrank test. Populations in both arms were similar. One-year survival was similar in the overall population (27/44 patients (61.4%) in the enteral nutrition arm vs. 36/55 (65.5%) in the control arm; Logrank P = 0.60) and in the subgroup suffering from malnutrition [18/29 patients (62.1%) in the enteral nutrition arm vs. 20/32 (62.5%) in the control arm; Logrank P = 0.99]. There was no statistical difference for bilirubin, prothrombin rate, Child-Pugh score, albumin or nutritional assessment. Complications during treatment (bleeding, encephalopathy, infection) occurred in 23% of patients in the enteral nutrition group (10/44) vs. 16% (9/55) of the control patients (P = 0.59). Enteral nutrition does not improve the survival and hepatic or nutritional parameters of cirrhotic patients with jaundice. © 2012 Blackwell Publishing Ltd.

Prediabetes in pregnancy, can early intervention improve outcomes? A feasibility study for a parallel randomised clinical trial.

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Hughes, Ruth C E; Rowan, Janet; Williman, Jonathan

2018-03-03

Measurement of glycated haemoglobin (HbA1c) in early pregnancy is routine in New Zealand to identify women with diabetes and prediabetes. However, the benefit of early intervention in women with prediabetes is inconclusive. Our aim was to test the feasibility of a two-arm parallel randomised controlled trial of standard care versus early intervention in pregnancies complicated by prediabetes. Two tertiary referral centres in New Zealand. Women measured at booking, without pre-existing diabetes. Randomisation was done by remote web-based allocation into one of two groups. Women in the early intervention group attended an antenatal diabetes clinic, commenced daily home blood glucose monitoring, and medication was prescribed if lifestyle measures failed to maintain target blood glucose levels. Controls received lifestyle education, continued standard care with their midwife and/or obstetrician, and were asked to perform a 75 g oral glucose tolerance test at 24 weeks' gestation with a referral to clinic if this test was positive. Both groups received lifestyle questionnaires at recruitment and in late pregnancy. Recruitment rate, adherence to protocol and validation of potential primary outcomes. Recruitment rates were lower than expected, especially in Māori and Pacific women. Non-adherence to allocated treatment protocol was significant, 42% (95% CI 24% to 61%) in the early intervention group and 30% (95% CI 16% to 51%) in controls. Caesarean section and pre-eclampsia were signalled as potential primary outcomes, due to both the high observed incidence in the control group and ease of measurement. For a future definitive trial, extending the gestation of eligibility and stepped-wedge cluster randomisation may overcome the identified feasibility issues. Consistent with published observational data, pre-eclampsia and emergency caesarean section could be included as primary outcome measures, both of which have a significant impact on maternal and neonatal morbidity and

Theory-driven group-based complex intervention to support self-management of osteoarthritis and low back pain in primary care physiotherapy: protocol for a cluster randomised controlled feasibility trial (SOLAS).

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Hurley, Deirdre A; Hall, Amanda M; Currie-Murphy, Laura; Pincus, Tamar; Kamper, Steve; Maher, Chris; McDonough, Suzanne M; Lonsdale, Chris; Walsh, Nicola E; Guerin, Suzanne; Segurado, Ricardo; Matthews, James

2016-01-21

International clinical guidelines consistently endorse the promotion of self-management (SM), including physical activity for patients with chronic low back pain (CLBP) and osteoarthritis (OA). Patients frequently receive individual treatment and advice to self-manage from physiotherapists in primary care, but the successful implementation of a clinical and cost-effective group SM programme is a key priority for health service managers in Ireland to maximise long-term outcomes and efficient use of limited and costly resources. This protocol describes an assessor-blinded cluster randomised controlled feasibility trial of a group-based education and exercise intervention underpinned by self-determination theory designed to support an increase in SM behaviour in patients with CLBP and OA in primary care physiotherapy. The primary care clinic will be the unit of randomisation (cluster), with each clinic randomised to 1 of 2 groups providing the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention or usual individual physiotherapy. Patients are followed up at 6 weeks, 2 and 6 months. The primary outcomes are the (1) acceptability and demand of the intervention to patients and physiotherapists, (2) feasibility and optimal study design/procedures and sample size for a definitive trial. Secondary outcomes include exploratory analyses of: point estimates, 95% CIs, change scores and effect sizes in physical function, pain and disability outcomes; process of change in target SM behaviours and selected mediators; and the cost of the intervention to inform a definitive trial. This feasibility trial protocol was approved by the UCD Human Research Ethics-Sciences Committee (LS-13-54 Currie-Hurley) and research access has been granted by the Health Services Executive Primary Care Research Committee in January 2014. The study findings will be disseminated to the research, clinical and health service communities through publication in

Effectiveness of a Peer Support Programme versus Usual Care in Disease Management of Diabetes Mellitus Type 2 regarding Improvement of Metabolic Control: A Cluster-Randomised Controlled Trial.

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Johansson, Tim; Keller, Sophie; Winkler, Henrike; Ostermann, Thomas; Weitgasser, Raimund; Sönnichsen, Andreas C

2016-01-01

Testing the effectiveness of peer support additionally to a disease management programme (DMP) for type 2 diabetes patients. Unblinded cluster-randomised controlled trial (RCT) involving 49 general practices, province of Salzburg, Austria. All patients enrolled in the DMP were eligible, n = 337 participated (intervention: 148 in 19 clusters; control: 189 in 20 clusters). The peer support intervention ran over 24 months and consisted of peer supporter recruitment and training, and group meetings weekly for physical exercise and monthly for discussion of diabetes related topics. At two-year follow-up, adjusted analysis revealed a nonsignificant difference in HbA1c change of 0.14% (21.97 mmol/mol) in favour of the intervention (95% CI -0.08 to 0.36%, p = 0.22). Baseline values were 7.02 ± 1.25% in the intervention and 7.08 ± 1.25 in the control group. None of the secondary outcome measures showed significant differences except for improved quality of life (EQ-5D-VAS) in controls (4.3 points on a scale of 100; 95% CI 0.08 to 8.53, p = 0.046) compared to the intervention group. Our peer support intervention as an additional DMP component showed no significant effect on HbA1c and secondary outcome measures. Further RTCs with a longer follow-up are needed to reveal whether peer support will have clinically relevant effects. This trial has been registered with Current Controlled Trials Ltd. (ISRCTN10291077).

Precommitting to choose wisely about low-value services: a stepped wedge cluster randomised trial.

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Kullgren, Jeffrey Todd; Krupka, Erin; Schachter, Abigail; Linden, Ariel; Miller, Jacquelyn; Acharya, Yubraj; Alford, James; Duffy, Richard; Adler-Milstein, Julia

2018-05-01

Little is known about how to discourage clinicians from ordering low-value services. Our objective was to test whether clinicians committing their future selves (ie, precommitting) to follow Choosing Wisely recommendations with decision supports could decrease potentially low-value orders. We conducted a 12-month stepped wedge cluster randomised trial among 45 primary care physicians and advanced practice providers in six adult primary care clinics of a US community group practice.Clinicians were invited to precommit to Choosing Wisely recommendations against imaging for uncomplicated low back pain, imaging for uncomplicated headaches and unnecessary antibiotics for acute sinusitis. Clinicians who precommitted received 1-6 months of point-of-care precommitment reminders as well as patient education handouts and weekly emails with resources to support communication about low-value services.The primary outcome was the difference between control and intervention period percentages of visits with potentially low-value orders. Secondary outcomes were differences between control and intervention period percentages of visits with possible alternate orders, and differences between control and 3-month postintervention follow-up period percentages of visits with potentially low-value orders. The intervention was not associated with a change in the percentage of visits with potentially low-value orders overall, for headaches or for acute sinusitis, but was associated with a 1.7% overall increase in alternate orders (p=0.01). For low back pain, the intervention was associated with a 1.2% decrease in the percentage of visits with potentially low-value orders (p=0.001) and a 1.9% increase in the percentage of visits with alternate orders (p=0.007). No changes were sustained in follow-up. Clinician precommitment to follow Choosing Wisely recommendations was associated with a small, unsustained decrease in potentially low-value orders for only one of three targeted conditions and

Effects of a supportive educational nursing care programme on fatigue and quality of life in patients with heart failure: a randomised controlled trial.

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Wang, Tzu-Chieh; Huang, Jin-Long; Ho, Wen-Chao; Chiou, Ai-Fu

2016-04-01

Fatigue is a common symptom in patients with heart failure that is easy to ignore. In addition, fatigue may affect patients' physical function and psychosocial conditions that can impair their quality of life. An effective nursing care programme is required to alleviate patients' fatigue and improve their quality of life. To investigate the effects of a supportive educational nursing care programme on fatigue and quality of life in patients with heart failure. A randomised controlled trial design was used. Ninety-two patients with heart failure were randomly assigned to an intervention group (n=47) or a control group (n=45). The patients in the intervention group participated in 12 weeks of a supportive educational nursing care programme including fatigue assessment, education, coaching self-care and evaluation. The intervention was conducted by a cardiac nurse during four face-to-face interviews and three follow-up telephone interviews. Fatigue and quality of life were assessed at the baseline and 4 weeks, 8 weeks and 12 weeks after enrollment in both groups. The participants in the intervention group exhibited a significant decrease in the level of fatigue after 12 weeks, whereas those in the control group exhibited no significant changes. Compared with the control group, the intervention group exhibited a significantly greater decrease in the level of fatigue and significantly greater improvement in quality of life after 12 weeks of intervention. The supportive educational nursing care programme was recommended to alleviate fatigue and improve quality of life in patients with heart failure. © The European Society of Cardiology 2015.

Improving distress in dialysis (iDiD): a feasibility two-arm parallel randomised controlled trial of an online cognitive behavioural therapy intervention with and without therapist-led telephone support for psychological distress in patients undergoing haemodialysis.

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Hudson, Joanna L; Moss-Morris, Rona; Game, David; Carroll, Amy; McCrone, Paul; Hotopf, Matthew; Yardley, Lucy; Chilcot, Joseph

2016-04-12

Psychological distress is common in end-stage kidney disease (ESKD) and is associated with poorer health outcomes. Cognitive behavioural therapy (CBT) is recommended in UK clinical guidelines for the management of depression in people with long-term conditions. Access to skilled therapists competent in managing the competing mental and physical health demands of ESKD is limited. Online CBT treatments tailored to the needs of the ESKD population offers a pragmatic solution for under-resourced services. This study examines the feasibility and acceptability of implementing a two-arm parallel randomised controlled trial of online CBT with (intervention arm) and without (control arm) therapist support to improve psychological distress in patients undergoing haemodialysis. Patients will be screened for depression and anxiety while attending for their haemodialysis treatments. We aim to recruit 60 adult patients undergoing haemodialysis who meet criteria for mild to moderately severe symptoms of depression and/or anxiety. Patients will be randomised individually (using a 1:1 computerised sequence ratio) to either online CBT with therapist telephone support (intervention arm), or online CBT with no therapist (control arm). Outcomes include feasibility and acceptability descriptive data on rates of recruitment, randomisation, retention and treatment adherence. Self-report outcomes include measures of depression (Patient Health Questionnaire-9), anxiety (Generalised Anxiety Disorder-7), quality of life (Euro-QoL), service use (client service receipt inventory) and illness cognitions (brief illness perception questionnaire). A qualitative process evaluation will also be conducted. The statistician will be blinded to treatment allocation. A National Health Service (NHS) research ethics committee approved the study. Data from this study will provide essential information for the design and testing of further interventions to ameliorate distress in patients undergoing dialysis

Protocol for the SEED-trial: Supported Employment and preventing Early Disability

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Vigdis Sveinsdottir

2016-07-01

Full Text Available Abstract Background Early withdrawal or exclusion from the labor market leads to significant personal and societal costs. In Norway, the increasing numbers of young adults receiving disability pension is a growing problem. While a large body of research demonstrates positive effects of Supported Employment (SE in patients with severe mental illness, no studies have yet investigated the effectiveness of SE in young adults with a range of social and health conditions who are receiving benefits. Methods/design The SEED-trial is a randomized controlled trial (RCT comparing traditional vocational rehabilitation (TVR to SE in 124 unemployed individuals between the ages of 18-29 who are receiving benefits due to various social- or health-related problems. The primary outcome is labor market participation during the first year after enrollment. Secondary outcomes include physical and mental health, health behaviors, and well-being, collected at baseline, 6, and 12 months. A cost-benefit analysis will also be conducted. Discussion The SEED-trial is the first RCT to compare SE to TVR in this important and vulnerable group, at risk of being excluded from working life at an early age. Trial registration Clinicaltrials.gov, registration number NCT02375074 . Registered on December 3rd 2014

Tying it all together--The PASS to Success: a comprehensive look at promoting job retention for workers with psychiatric disabilities in a supported employment program.

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Dorio, JoAnn

2004-01-01

Job initiation rates are steadily improving for people with severe and persistent mental illnesses. Yet, job retention rates, especially for those individuals who historically have had difficulty maintaining employment, continue to concern vocational rehabilitation professionals. In this paper, the author develops and refines her ideas that were presented in a previous research paper titled "Differences in Job Retention in a Supported Employment Program, Chinook Clubhouse." A more complete model, "The PASS to Success," is suggested by incorporating existing research with the author's revised work. Components of the model (Placement, Attitude, Support, Skills), can be used to predict vocational success and promote job retention.

Synchronized mechanical ventilation for respiratory support in newborn infants.

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Greenough, Anne; Murthy, Vadivelam; Milner, Anthony D; Rossor, Thomas E; Sundaresan, Adesh

2016-08-19

During synchronised mechanical ventilation, positive airway pressure and spontaneous inspiration coincide. If synchronous ventilation is provoked, adequate gas exchange should be achieved at lower peak airway pressures, potentially reducing baro/volutrauma, air leak and bronchopulmonary dysplasia. Synchronous ventilation can potentially be achieved by manipulation of rate and inspiratory time during conventional ventilation and employment of patient-triggered ventilation. To compare the efficacy of:(i) synchronised mechanical ventilation, delivered as high-frequency positive pressure ventilation (HFPPV) or patient-triggered ventilation (assist control ventilation (ACV) and synchronous intermittent mandatory ventilation (SIMV)), with conventional ventilation or high-frequency oscillation (HFO);(ii) different types of triggered ventilation (ACV, SIMV, pressure-regulated volume control ventilation (PRVCV), SIMV with pressure support (PS) and pressure support ventilation (PSV)). We used the standard search strategy of the Cochrane Neonatal Review group to search the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 5), MEDLINE via PubMed (1966 to June 5 2016), EMBASE (1980 to June 5 2016), and CINAHL (1982 to June 5 2016). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. Randomised or quasi-randomised clinical trials comparing synchronised ventilation delivered as HFPPV to CMV, or ACV/SIMV to CMV or HFO in neonates. Randomised trials comparing different triggered ventilation modes (ACV, SIMV, SIMV plus PS, PRVCV and PSV) in neonates. Data were collected regarding clinical outcomes including mortality, air leaks (pneumothorax or pulmonary interstitial emphysema (PIE)), severe intraventricular haemorrhage (grades 3 and 4), bronchopulmonary dysplasia (BPD) (oxygen dependency beyond 28 days), moderate/severe BPD (oxygen

Maternal Employment and Early Adolescent Substance Use.

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Hillman, Stephen B.; Sawilowsky, Shlomo S.

1991-01-01

Examined effects of maternal employment on use of alcohol, cigarettes, marijuana, and other drugs by ninth graders (n=48). Comparison of maternal employment patterns (full-time versus part-time versus not employed outside the home) indicated no significant differences in substance use behavior among adolescents. Findings support literature on…

High dose melphalan in the treatment of advanced neuroblastoma: results of a randomised trial (ENSG-1) by the European Neuroblastoma Study Group.

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Pritchard, Jon; Cotterill, Simon J; Germond, Shirley M; Imeson, John; de Kraker, Jan; Jones, David R

2005-04-01

High dose myeloablative chemotherapy ("megatherapy"), with haematopoietic stem cell support, is now widely used to consolidate response to induction chemotherapy in patients with advanced neuroblastoma. In this study (European Neuroblastoma Study Group, ENSG1), the value of melphalan myeloablative "megatherapy" was evaluated in a randomised, multi-centre trial. Between 1982 and 1985, 167 children with stages IV and III neuroblastoma (123 stage IV > 1 year old at diagnosis and 44 stage III and stage IV from 6 to 12 months old at diagnosis) were treated with oncovin, cisplatin, epipodophyllotoxin, and cyclophosphamide (OPEC) induction chemotherapy every 3 weeks. After surgical excision of primary tumour, the 90 patients (69% of the total) who achieved complete response (CR) or good partial response (GPR) were eligible for randomisation either to high dose melphalan (180 mg per square meter) with autologous bone marrow support or to no further treatment. Sixty-five (72%) of eligible children were actually randomised and 21 of these patients were surviving at time of this analysis, with median follow-up from randomisation of 14.3 years. Five year event-free survival (EFS) was 38% (95% confidence interval (CI) 21-54%) in the melphalan-treated group and 27% (95% CI 12-42%) in the "no-melphalan" group. This difference was not statistically significant (P = 0.08, log rank test) but for the 48 randomised stage IV patients aged >1 year at diagnosis outcome was significantly better in the melphalan-treated group-5 year EFS 33% versus 17% (P = 0.01, log rank test). In this trial, high dose melphalan improved the length of EFS and overall survival of children with stage IV neuroblastoma >1 year of age who achieved CR or GPR after OPEC induction therapy and surgery. Multi-agent myeloablative regimens are now widely used as consolidation therapy for children with stage IV disease and in those with other disease stages when the MYCN gene copy number in tumour cells is amplified

Protocol for a randomised controlled trial of 90% kanuka honey versus 5% aciclovir for the treatment of herpes simplex labialis in the community setting.

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Semprini, Alex; Singer, Joseph; Shortt, Nicholas; Braithwaite, Irene; Beasley, Richard

2017-08-03

Worldwide, about 90% of people are infected with the herpes simplex virus, 30% of whom will experience recurrent herpes simplex labialis, commonly referred to as 'cold sores', which can last up to 10 days. The most common treatment is aciclovir cream which reduces healing time by just half a day compared with no specific treatment. This is a protocol for a randomised controlled trial (RCT) to determine the efficacy of medical grade kanuka honey-based topical treatment (Honevo) in reducing the healing time and pain of cold sores, compared with topical aciclovir treatment (Viraban). This open-label, parallel-group, active comparator superiority RCT will compare the efficacy of medical grade kanuka honey with 5% aciclovir cream in the treatment of cold sores in the setting of a pharmacy research network of 60 sites throughout New Zealand. Adults presenting with a cold sore (N=950) will be randomised by pharmacy-based investigators. The pharmacy-based investigators will dispense the investigational product to randomised participants and both study groups apply the treatment five times daily until their skin returns to normal or for 14 days, whichever occurs first. In response to a daily SMS message, participants complete an assessment of their cold sore healing, with reference to a visual guide, and transmit it to the investigators by a smartphone eDiary in real time. The primary outcome variable is time (in days) from randomisation to return to normal skin. Secondary endpoints include total healing time stratified by stage of the lesion at onset of treatment, highest pain severity and time to pain resolution. New Zealand Ethics Registration 15/NTB/93. Results will be published in a peer-reviewed medical journal, presented at academic meetings and reported to participants. Australia New Zealand Clinical Trials Registry: ACTRN12615000648527, pre-results.SCOTT Registration: 15/SCOTT/14 PROTOCOL VERSION: 4.0 (12 June 2017). © Article author(s) (or their employer(s

Doctor Referral of Overweight People to a Low-Energy Treatment (DROPLET) in primary care using total diet replacement products: a protocol for a randomised controlled trial.

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Jebb, Susan A; Astbury, Nerys M; Tearne, Sarah; Nickless, Alecia; Aveyard, Paul

2017-08-04

The global prevalence of obesity has risen significantly in recent decades. There is a pressing need to identify effective interventions to treat established obesity that can be delivered at scale. The aim of the Doctor Referral of Overweight People to a Low-Energy Treatment (DROPLET) study is to determine the clinical effectiveness, feasibility and acceptability of referral to a low-energy total diet replacement programme compared with usual weight management interventions in primary care. The DROPLET trial is a randomised controlled trial comparing a low-energy total diet replacement programme with usual weight management interventions delivered in primary care. Eligible patients will be recruited through primary care registers and randomised to receive a behavioural support programme delivered by their practice nurse or a referral to a commercial provider offering an initial 810 kcal/d low-energy total diet replacement programme for 8 weeks, followed by gradual food reintroduction, along with weekly behavioural support for 24 weeks. The primary outcome is weight change at 12 months. The secondary outcomes are weight change at 3 and 6 months, the proportion of participants achieving 5% and 10% weight loss at 12 months, and change in fat mass, haemoglobin A1c, low-density lipoprotein cholesterol and systolic and diastolic blood pressure at 12 months. Data will be analysed on the basis of intention to treat. Qualitative interviews on a subsample of patients and healthcare providers will assess their experiences of the weight loss programmes and identify factors affecting acceptability and adherence. This study has been reviewed and approved by the National Health ServiceHealth Research Authority (HRA)Research Ethics Committee (Ref: SC/15/0337). The trial findings will be disseminated to academic and health professionals through presentations at meetings and peer-reviewed journals and to the public through the media. If the intervention is effective, the results

Compliance with the CONSORT checklist in obstetric anaesthesia randomised controlled trials.

Science.gov (United States)

Halpern, S H; Darani, R; Douglas, M J; Wight, W; Yee, J

2004-10-01

The Consolidated Standards for Reporting of Trials (CONSORT) checklist is an evidence-based approach to help improve the quality of reporting randomised controlled trials. The purpose of this study was to determine how closely randomised controlled trials in obstetric anaesthesia adhere to the CONSORT checklist. We retrieved all randomised controlled trials pertaining to the practice of obstetric anaesthesia and summarised in Obstetric Anesthesia Digest between March 2001 and December 2002 and compared the quality of reporting to the CONSORT checklist. The median number of correctly described CONSORT items was 65% (range 36% to 100%). Information pertaining to randomisation, blinding of the assessors, sample size calculation, reliability of measurements and reporting of the analysis were often omitted. It is difficult to determine the value and quality of many obstetric anaesthesia clinical trials because journal editors do not insist that this important information is made available to readers. Both clinicians and clinical researchers would benefit from uniform reporting of randomised trials in a manner that allows rapid data retrieval and easy assessment for relevance and quality.

Simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE): protocol for a randomised evaluation.

Science.gov (United States)

Rosen, Sydney; Fox, Matthew P; Larson, Bruce A; Brennan, Alana T; Maskew, Mhairi; Tsikhutsu, Isaac; Bii, Margaret; Ehrenkranz, Peter D; Venter, Wd Francois

2017-05-28

African countries are rapidly adopting guidelines to offer antiretroviral therapy (ART) to all HIV-infected individuals, regardless of CD4 count. For this policy of 'treat all' to succeed, millions of new patients must be initiated on ART as efficiently as possible. Studies have documented high losses of treatment-eligible patients from care before they receive their first dose of antiretrovirals (ARVs), due in part to a cumbersome, resource-intensive process for treatment initiation, requiring multiple clinic visits over a several-week period. The Simplified Algorithm for Treatment Eligibility (SLATE) study is an individually randomised evaluation of a simplified clinical algorithm for clinicians to reliably determine a patient's eligibility for immediate ART initiation without waiting for laboratory results or additional clinic visits. SLATE will enrol and randomise (1:1) 960 adult, HIV-positive patients who present for HIV testing or care and are not yet on ART in South Africa and Kenya. Patients randomised to the standard arm will receive routine, standard of care ART initiation from clinic staff. Patients randomised to the intervention arm will be administered a symptom report, medical history, brief physical exam and readiness assessment. Patients who have positive (satisfactory) results for all four components of SLATE will be dispensed ARVs immediately, at the same clinic visit. Patients who have any negative results will be referred for further clinical investigation, counselling, tests or other services prior to being dispensed ARVs. After the initial visit, follow-up will be by passive medical record review. The primary outcomes will be ART initiation ≤28 days and retention in care 8 months after study enrolment. Ethics approval has been provided by the Boston University Institutional Review Board, the University of the Witwatersrand Human Research Ethics Committee (Medical) and the KEMRI Scientific and Ethics Review Unit. Results will be published in

Protocol for a single-centre, randomised controlled study of a preoperative rehabilitation bundle in the frail and elderly undergoing abdominal surgery.

Science.gov (United States)

Abdullah, Hairil Rizal; Lien, Victoria Peixin; Ong, Hwee Kuan; Er, Pei Ling; Hao, Ying; Khan, Shariq Ali; Liu, Christopher Weiyang

2017-08-04

Frail patients have decreased physiological reserves and consequently, they are unable to recover as quickly from surgery. Frailty, as an entity, is a risk factor of increased morbidity and mortality. It is also associated with a longer time to discharge. This trial is undertaken to determine if a novel prehabilitation protocol (10-day bundle of interventions-physiotherapy, nutritional supplementation and cognitive training) can reduce the postoperative length of stay of frail patients who are undergoing elective abdominal surgery, compared with standard care. This is a prospective, single-centre, randomised controlled trial with two parallel arms. 62 patients who are frail and undergoing elective abdominal surgery will be recruited and randomised to receive either a novel prehabilitation protocol or standard care. Participants will receive telephone reminders preoperatively to encourage protocol compliance. Data will be collected for up to 30 days postoperatively. The primary outcome of the trial will be the postoperative length of stay and the secondary outcomes are the postoperative complications and functional recovery during the hospital admission. This study has been approved by the Singapore General Hospital Institutional Review Board (CIRB Ref: 2016/2584). The study is also listed on ClinicalTrials.gov (Trial number: NCT02921932). All participants will sign an informed consent form before randomisation and translators will be made available to non-English speaking patients. The results of this study will be published in peer-reviewed journals as well as national and international conferences. The data collected will also be made available in a public data repository. NCT02921932 (ClinicalTrials.gov). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches.

Science.gov (United States)

Elliott, Daisy; Husbands, Samantha; Hamdy, Freddie C; Holmberg, Lars; Donovan, Jenny L

2017-11-01

The importance of evidence from randomised trials is now widely recognised, although recruitment is often difficult. Qualitative research has shown promise in identifying the key barriers to recruitment, and interventions have been developed to reduce organisational difficulties and support clinicians undertaking recruitment. This article provides an introduction to qualitative research techniques and explains how this approach can be used to understand-and subsequently improve-recruitment and informed consent within a range of clinical trials. A literature search was performed using Medline, Embase, and CINAHL. All studies with qualitative research methods that focused on the recruitment activity of clinicians were included in the review. The majority of studies reported that organisational difficulties and lack of time for clinical staff were key barriers to recruitment. However, a synthesis of qualitative studies highlighted the intellectual and emotional challenges that arise when combining research with clinical roles, particularly in relation to equipoise and patient eligibility. To support recruiters to become more comfortable with the design and principles of randomised controlled trials, interventions have been developed, including the QuinteT Recruitment Intervention, which comprises in-depth investigation of recruitment obstacles in real time, followed by implementation of tailored strategies to address these challenges as the trial proceeds. Qualitative research can provide important insights into the complexities of recruitment to trials and inform the development of interventions, and provide support and training initiatives as required. Investigators should consider implementing such methods in trials expected to be challenging or recruiting below target. Qualitative research is a term used to describe a range of methods that can be implemented to understand participants' perspectives and behaviours. Data are gathered from interviews, focus groups

Clinical and cost effectiveness of mechanical support for severe ankle sprains: design of a randomised controlled trial in the emergency department [ISRCTN 37807450

Directory of Open Access Journals (Sweden)

Hutton JL

2005-01-01

Full Text Available Abstract Background The optimal management for severe sprains (Grades II and III of the lateral ligament complex of the ankle is unclear. The aims of this randomised controlled trial are to estimate (1 the clinical effectiveness of three methods of providing mechanical support to the ankle (below knee cast, Aircast® brace and Bledsoe® boot in comparison to Tubigrip®, and (2 to compare the cost of each strategy, including subsequent health care costs. Methods/design Six hundred and fifty people with a diagnosis of severe sprain are being identified through emergency departments. The study has been designed to complement routine practice in the emergency setting. Outcomes are recovery of mobility (primary outcome and usual activity, residual symptoms and need for further medical, rehabilitation or surgical treatment. Parallel economic and qualitative studies are being conducted to aid interpretation of the results and to evaluate the cost-effectiveness of the interventions. Discussion This paper highlights the design, methods and operational aspects of a clinical trial of acute injury management in the emergency department.

Draining after breast reduction: a randomised controlled inter-patient study

NARCIS (Netherlands)

Corion, Leonard U. M.; Smeulders, Mark J. C.; van Zuijlen, Paul P. M.; van der Horst, Chantal M. A. M.

2009-01-01

One hundred and seven bilateral breast reductions were prospectively randomised during surgery to receive or not receive wound drains. Fifty-five patients were randomised to have a drain and 52 to not have a drain. There was no statistical difference in the number of complications between the

Effectiveness and cost of recruitment strategies for a community-based randomised controlled trial among rainwater drinkers.

Science.gov (United States)

Rodrigo, Shelly; Sinclair, Martha; Cunliffe, David; Leder, Karin

2009-07-16

Community-based recruitment is challenging particularly if the sampling frame is not easily defined as in the case of people who drink rainwater. Strategies for contacting participants must be carefully considered to maximise generalisability and minimise bias of the results. This paper assesses the recruitment strategies for a 1-year double-blinded randomised trial on drinking untreated rainwater. The effectiveness of the recruitment strategies and associated costs are described. Community recruitment of households from Adelaide, Australia occurred from February to July 2007 using four methods: electoral roll mail-out, approaches to schools and community groups, newspaper advertising, and other media involvement. Word of mouth communication was also assessed. A total of 810 callers were screened, with 53.5% eligible. Of those who were eligible and sent further information, 76.7% were willing to participate in the study and 75.1% were enrolled. The target for recruitment was 300 households, and this was achieved. The mail-out was the most effective method with respect to number of households randomised, while recruitment via schools had the highest yield (57.3%) and was the most cost effective when considering cost per household randomised (AUD$147.20). Yield and cost effectiveness were lowest for media advertising. The use of electoral roll mail-out and advertising via schools were effective in reaching households using untreated rainwater for drinking. Employing multiple strategies enabled success in achieving the recruitment target. In countries where electoral roll extracts are available to researchers, this method is likely to have a high yield for recruitment into community-based epidemiological studies.

Support for Food and Beverage Worksite Wellness Strategies and Sugar-Sweetened Beverage Intake Among Employed U.S. Adults.

Science.gov (United States)

Lee-Kwan, Seung Hee; Pan, Liping; Kimmons, Joel; Foltz, Jennifer; Park, Sohyun

2017-03-01

Sugar-sweetened beverage (SSB) consumption is high among U.S. adults and is associated with obesity. Given that more than 100 million Americans consume food or beverages at work daily, the worksite may be a venue for interventions to reduce SSB consumption. However, the level of support for these interventions is unknown. We examined associations between workday SSB intake and employees' support for worksite wellness strategies (WWSs). We conducted a cross-sectional study using data from Web-based annual surveys that gather information on health-related attitudes and behaviors. Study setting was the United States. A total of 1924 employed adults (≥18 years) selected using probability-based sampling. The self-reported independent variable was workday SSB intake (0, food/drink, (3) available healthy options, and (4) less available SSB. Multivariable logistic regression was used to control for sociodemographic variables, employee size, and availability of cafeteria/vending machine. About half of employees supported accessible free water (54%), affordable healthy food/drink (49%), and available healthy options (46%), but only 28% supported less available SSB. Compared with non-SSB consumers, daily SSB consumers were significantly less supportive of accessible free water (adjusted odds ratio, .67; p < .05) or less available SSB (odds ratio, .49; p < .05). Almost half of employees supported increasing healthy options within worksites, although daily workday SSB consumers were less supportive of certain strategies. Lack of support could be a potential barrier to the successful implementation of certain worksite interventions.

Prevalence and reporting of recruitment, randomisation and treatment errors in clinical trials: A systematic review.

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Yelland, Lisa N; Kahan, Brennan C; Dent, Elsa; Lee, Katherine J; Voysey, Merryn; Forbes, Andrew B; Cook, Jonathan A

2018-06-01

Background/aims In clinical trials, it is not unusual for errors to occur during the process of recruiting, randomising and providing treatment to participants. For example, an ineligible participant may inadvertently be randomised, a participant may be randomised in the incorrect stratum, a participant may be randomised multiple times when only a single randomisation is permitted or the incorrect treatment may inadvertently be issued to a participant at randomisation. Such errors have the potential to introduce bias into treatment effect estimates and affect the validity of the trial, yet there is little motivation for researchers to report these errors and it is unclear how often they occur. The aim of this study is to assess the prevalence of recruitment, randomisation and treatment errors and review current approaches for reporting these errors in trials published in leading medical journals. Methods We conducted a systematic review of individually randomised, phase III, randomised controlled trials published in New England Journal of Medicine, Lancet, Journal of the American Medical Association, Annals of Internal Medicine and British Medical Journal from January to March 2015. The number and type of recruitment, randomisation and treatment errors that were reported and how they were handled were recorded. The corresponding authors were contacted for a random sample of trials included in the review and asked to provide details on unreported errors that occurred during their trial. Results We identified 241 potentially eligible articles, of which 82 met the inclusion criteria and were included in the review. These trials involved a median of 24 centres and 650 participants, and 87% involved two treatment arms. Recruitment, randomisation or treatment errors were reported in 32 in 82 trials (39%) that had a median of eight errors. The most commonly reported error was ineligible participants inadvertently being randomised. No mention of recruitment, randomisation

Friendship and money: A qualitative study of service users' experiences of participating in a supported socialisation programme.

Science.gov (United States)

Sheridan, Ann; O'Keeffe, Donal; Coughlan, Barbara; Frazer, Kate; Drennan, Johnathan; Kemple, Mary

2018-06-01

Social opportunities can be limited in the lives of people with enduring mental illness (EMI) due to psychiatric stigma, restricted home environments and employment barriers. Supported socialisation programmes have the potential to redress the impact of social isolation. To explore the experiences of service users with EMI taking part in a supported socialisation programme, using written diary entries. This article reports on the qualitative component of a randomised controlled trial of supported socialisation for people with EMI (published previously in this journal). Trial participation involved (1) being matched with a volunteer partner and engaging in social/leisure activities while receiving a stipend of €20 or (2) receiving this stipend only and engaging in self-driven socialisation. Participants completed written diaries documenting their perspectives on their experiences of supported socialisation. Data were analysed using Thematic Analysis. Experiences of participation were characterised by involvement 'normalising' life, fostering a sense of connectedness, improving physical health, and facilitating engagement with culture. Taking part helped participants integrate socialising into their identity, enhanced their perceived capacity to be social, and cemented/expanded social networks. Participants also experienced significant obstacles to socialisation. Supported socialisation can increase confidence, social competence and self-agency; buffer against psychiatric stigma; build social capital; and afford opportunities to enhance social integration, inclusion and belonging.

Employers' perspectives of students in a master of public health (nutrition) program.

Science.gov (United States)

Fox, Ann; Emrich, Teri

2012-01-01

Efforts to support workforce development led to the launch of a new master of public health program aimed at improving access to graduate studies for practising nutrition professionals. The first cohort of students identified employer support as a key determinant of their success. In order to identify ways of addressing both student and employer needs, we explored the perspectives of students' employers. Seventeen in-depth, semi-structured, open-ended interviews were conducted with employers. Interviews were audiotaped and transcribed. Transcripts were organized using NVivo software and coded thematically. All employers indicated support for employee education and development in principle, but most faced practical challenges related to limited staffing during education leaves. Organizational policies varied considerably across employer groups. Collective agreements that guided education policy were seen to ensure consistent support for employees, but also to limit creative approaches to education support in some situations. Employers highly valued graduate student projects that were directly related to the workplace; these projects presented opportunities for collaboration among the university, students, and employers. Universities need to work with employers and other stakeholders to identify ways of overcoming barriers to public health nutrition graduate education and workforce development.

Working Women Making It Work: Intimate Partner Violence, Employment, and Workplace Support

Science.gov (United States)

Swanberg, Jennifer; Macke, Caroline; Logan, TK

2007-01-01

Partner violence may have significant consequences on women's employment, yet limited information is available about how women cope on the job with perpetrators' tactics and the consequences of her coping methods on employment status. This article investigates whether there is an association between workplace disclosure of victimization and…

Functional social support, psychological capital, and depressive and anxiety symptoms among people living with HIV/AIDS employed full-time.

Science.gov (United States)

Liu, Li; Pang, Ran; Sun, Wei; Wu, Ming; Qu, Peng; Lu, Chunming; Wang, Lie

2013-12-01

Psychological distress (e.g., depression and anxiety) has been regarded as the main cause of leaving work for people living with HIV/AIDS (PLWHA) in workplaces. This study aims to explore the associations of functional social support (FSS) and psychological capital (PC) with depressive and anxiety symptoms among PLWHA employed full-time. This cross-sectional study was performed in Liaoning, China, during the period of December 2010-April 2011. The Center for Epidemiologic Studies Depression Scale, the Zung Self-Rating Anxiety Scale, the Duke-UNC Functional Social Support Questionnaire, and the Psychological Capital Questionnaire were completed by PLWHA employed full-time. Structural equation modeling was used to test the proposed relationships between variables. Asymptotic and resampling strategies were performed to explore the mediating roles of PC and its components (self-efficacy, hope, optimism, resilience). Of 320 participants surveyed, 66.3% had depressive symptoms, and 45.6% had anxiety symptoms. Significant negative associations of FSS and PC with depressive and anxiety symptoms were revealed. PC (a*b = -0.209, BCa 95% CI: -0.293, -0.137, p < 0.05), hope (a*b = -0.103, BCa 95% CI: -0.192, -0.034, p < 0.05), and optimism (a*b = -0.047, BCa 95% CI: -0.106, -0.008, p < 0.05) significantly mediated the association between FSS and depressive symptoms. PC (a*b = -0.151, BCa 95% CI: -0.224, -0.095, p < 0.05) and self-efficacy (a*b = -0.080, BCa 95% CI: -0.158, -0.012, p < 0.05) significantly mediated the FSS-anxiety symptoms association. FSS and PC could help reduce depressive and anxiety symptoms among PLWHA employed full-time. PC fully mediates the associations of FSS with depressive and anxiety symptoms. In addition to enhancing FSS, PC development could be included in the prevention and treatment strategies for depressive and anxiety symptoms targeted at PLWHA employed full-time.

Promoting public awareness of randomised clinical trials using the media: the 'Get Randomised' campaign.

Science.gov (United States)

Mackenzie, Isla S; Wei, Li; Rutherford, Daniel; Findlay, Evelyn A; Saywood, Wendy; Campbell, Marion K; Macdonald, Thomas M

2010-02-01

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT * Recruitment is key to the success of clinical trials. * Many clinical trials fail to achieve adequate recruitment. * Public understanding and engagement in clinical research could be improved. WHAT THIS STUDY ADDS * 'Get Randomised' is the first campaign of its kind in the UK. * It is possible to improve public awareness of clinical research using the media. * Further work is needed to determine whether improved public awareness leads to increased participation in clinical research in the future. AIM To increase public awareness and understanding of clinical research in Scotland. METHODS A generic media campaign to raise public awareness of clinical research was launched in 2008. The 'Get Randomised' campaign was a Scotland-wide initiative led by the University of Dundee in collaboration with other Scottish universities. Television, radio and newspaper advertising showed leading clinical researchers, general practitioners and patients informing the public about the importance of randomised clinical trials (RCTs). 'Get Randomised' was the central message and interested individuals were directed to the http://www.getrandomised.org website for more information. To assess the impact of the campaign, cross-sectional surveys were conducted in representative samples of 1040 adults in Scotland prior to campaign launch and again 6 months later. RESULTS There was an improvement in public awareness of clinical trials following the campaign; 56.7% [95% confidence interval (CI) 51.8, 61.6] of the sample recalled seeing or hearing advertising about RCTs following the campaign compared with 14.8% (10.8, 18.9) prior to the campaign launch (difference = 41.4%; 95% CI for difference 35.6, 48.3; P advertising, 49% felt that the main message was that people should take part more in medical research. However, on whether they would personally take part in a clinical trial if asked, there was little difference in response following the campaign

Rigorous Analysis of a Randomised Number Field Sieve

OpenAIRE

Lee, Jonathan; Venkatesan, Ramarathnam

2018-01-01

Factorisation of integers $n$ is of number theoretic and cryptographic significance. The Number Field Sieve (NFS) introduced circa 1990, is still the state of the art algorithm, but no rigorous proof that it halts or generates relationships is known. We propose and analyse an explicitly randomised variant. For each $n$, we show that these randomised variants of the NFS and Coppersmith's multiple polynomial sieve find congruences of squares in expected times matching the best-known heuristic e...

What interventions can improve quality of life or psychosocial factors of individuals with knee osteoarthritis? A systematic review with meta-analysis of primary outcomes from randomised controlled trials.

Science.gov (United States)

Briani, Ronaldo Valdir; Ferreira, Amanda Schenatto; Pazzinatto, Marcella Ferraz; Pappas, Evangelos; De Oliveira Silva, Danilo; Azevedo, Fábio Mícolis de

2018-03-16

To systematically review evidence of primary outcomes from randomised controlled trials (RCTs) examining the effect of treatment strategies on quality of life (QoL) or psychosocial factors in individuals with knee osteoarthritis (OA). Systematic review with meta-analysis. Medline, Embase, SPORTDiscus, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Web of Science were searched from inception to November 2017. We included RCTs investigating the effect of conservative interventions on QoL or psychosocial factors in individuals with knee OA. Only RCTs considering these outcomes as primary were included. Pooled data supported the use of exercise therapy compared with controls for improving health-related and knee-related QoL. There was limited evidence that a combined treatment of yoga, transcutaneous electrical stimulation and ultrasound may be effective in improving QoL. Limited evidence supported the use of cognitive behavioural therapies (with or without being combined with exercise therapy) for improving psychosocial factors such as self-efficacy, depression and psychological distress. Exercise therapy (with or without being combined with other interventions) seems to be effective in improving health-related and knee-related QoL or psychosocial factors of individuals with knee OA. In addition, evidence supports the use of cognitive behavioural therapies (with or without exercise therapy) for improving psychosocial factors such as self-efficacy, depression and psychological distress in individuals with knee OA. CRD42016047602. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Medicoeconomic analysis of lobectomy using thoracoscopy versus thoracotomy for lung cancer: a study protocol for a multicentre randomised controlled trial (Lungsco01).

Science.gov (United States)

Pagès, Pierre-Benoit; Abou Hanna, Halim; Bertaux, Anne-Claire; Serge Aho, Ludwig Serge; Magdaleinat, Pierre; Baste, Jean-Marc; Filaire, Marc; de Latour, Richard; Assouad, Jalal; Tronc, François; Jayle, Christophe; Mouroux, Jérome; Thomas, Pascal-Alexandre; Falcoz, Pierre-Emmanuel; Marty-Ané, Charles-Henri; Bernard, Alain

2017-06-15

In the last decade, video-assisted thoracoscopic surgery (VATS) lobectomy for non-small cell lung cancer (NSCLC) has had a major effect on thoracic surgery. Retrospective series have reported benefits of VATS when compared with open thoracotomy in terms of postoperative pain, postoperative complications and length of hospital stay. However, no large randomised control trial has been conducted to assess the reality of the potential benefits of VATS lobectomy or its medicoeconomic impact. The French National Institute of Health funded Lungsco01 to determine whether VATS for lobectomy is superior to open thoracotomy for the treatment of NSCLC in terms of economic cost to society. This trial will also include an analysis of postoperative outcomes, the length of hospital stay, the quality of life, long-term survival and locoregional recurrence. The study design is a two-arm parallel randomised controlled trial comparing VATS lobectomy with lobectomy using thoracotomy for the treatment of NSCLC. Patients will be eligible if they have proven or suspected lung cancer which could be treated by lobectomy. Patients will be randomised via an independent service. All patients will be monitored according to standard thoracic surgical practices. All patients will be evaluated at day 1, day 30, month 3, month 6, month 12 and then every year for 2 years thereafter. The recruitment target is 600 patients. The protocol has been approved by the French National Research Ethics Committee (CPP Est I: 09/06/2015) and the French Medicines Agency (09/06/2015). Results will be presented at national and international meetings and conferences and published in peer-reviewed journals. NCT02502318. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Randomised trial of mitral valve repair with leaflet resection versus leaflet preservation on functional mitral stenosis (The CAMRA CardioLink-2 Trial).

Science.gov (United States)

Chan, Vincent; Chu, Michael W A; Leong-Poi, Howard; Latter, David A; Hall, Judith; Thorpe, Kevin E; de Varennes, Benoit E; Quan, Adrian; Tsang, Wendy; Dhingra, Natasha; Yared, Kibar; Teoh, Hwee; Chu, F Victor; Chan, Kwan-Leung; Mesana, Thierry G; Connelly, Kim A; Ruel, Marc; Jüni, Peter; Mazer, C David; Verma, Subodh

2017-05-30

The gold-standard treatment of severe mitral regurgitation (MR) due to degenerative disease is valve repair, which is surgically performed with either a leaflet resection or leaflet preservation approach. Recent data suggest that functional mitral stenosis (MS) may occur following valve repair using a leaflet resection strategy, which adversely affects patient prognosis. A randomised comparison of these two approaches to mitral repair on functional MS has not been conducted. This is a prospective, multicentre randomised controlled trial designed to test the hypothesis that leaflet preservation leads to better preservation of mitral valve geometry, and therefore, will be superior to leaflet resection for the primary outcome of functional MS as assessed by 12-month mean mitral valve gradient at peak exercise. Eighty-eight patients with posterior leaflet prolapse will be randomised intraoperatively once deemed by the operating surgeon to feasibly undergo mitral repair using either a leaflet resection or leaflet preservation approach. Secondary end points include comparison of repair strategies with regard to mitral valve orifice area, leaflet coaptation height, 6 min walk test and a composite major adverse event end point consisting of recurrent MR ≥2+, death or hospital readmission for congestive heart failure within 12 months of surgery. Institutional ethics approval has been obtained from all enrolling sites. Overall, there remains clinical equipoise regarding the mitral valve repair strategy that is associated with the least likelihood of functional MS. This trial hopes to introduce high-quality evidence to help surgical decision making in this context. NCT02552771. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A randomised trial of the Flinders Program to improve patient self-management competencies in a range of chronic conditions: study rationale and protocol

Directory of Open Access Journals (Sweden)

Malcolm W. Battersby

2010-03-01

Full Text Available BackgroundSupporting self management is seen as an important healthservice strategy in dealing with the large and increasing healthburden of chronic conditions. Several types of selfmanagementprograms are available. Evidence to datesuggests that disease-specific and lay-led self managementprograms provide only part of the support needed forimproved outcomes. The Flinders Program is promising as ageneric self management intervention, which can becombined with targeted disease-specific and lay-ledinterventions, but it has yet to be evaluated for a range ofchronic conditions using a rigorous controlled trial design. Thispaper gives the rationale for a randomised controlled trial andprocess evaluation of the Flinders Program of chroniccondition self-management in community practice, and detailsand justifies the design of such a study.MethodThe design for a randomised trial and associated processevaluation, suited to evaluation of a complex and behaviouralintervention as it is applied in actual practice, is presented andjustified.ConclusionA randomised trial of the Flinders Program is required and afunctional design is presented. Results from this trial,currently underway, will test the effectiveness of the FlindersProgram in improving patient competencies in selfmanagementof chronic conditions in practice conditions.A process evaluation alongside the trial will exploresystem, provider and patient factors associated withgreater and lesser Program effectiveness.

Sustained employability of workers in a production environment: design of a stepped wedge trial to evaluate effectiveness and cost-benefit of the POSE program

Directory of Open Access Journals (Sweden)

van Holland Berry J

2012-11-01

Full Text Available Abstract Background Sustained employability and health are generating awareness of employers in an aging and more complex work force. To meet these needs, employers may offer their employees health surveillance programs, to increase opportunities to work on health and sustained employability. However, evidence for these health surveillance programs is lacking. The FLESH study (Functional Labour Evaluation for Sustained Health and employment was developed to evaluate a comprehensive workers’ health promotion program on its effectiveness, cost-benefit, and process of the intervention. Methods The study is designed as a cluster randomised stepped wedge trial with randomisation at company plant level and is carried out in a large meat processing company. Every contracted employee is offered the opportunity to participate in the POSE program (Promotion Of Sustained Employability. The main goals of the POSE program are 1 providing employee’s insight into their current employability and health status, 2 offering opportunities to improve employability and decrease health risks and 3 improving employability and health sustainably in order to keep them healthy at work. The program consists of a broad assessment followed by a counselling session and, if needed, a tailored intervention. Measurements will be performed at baseline and will be followed up at 20, 40, 60, 80, 106 and 132 weeks. The primary outcome measures are work ability, productivity and absenteeism. Secondary outcomes include health status, vitality, and psychosocial workload. A cost-benefit study will be conducted from the employers’ perspective. A process evaluation will be conducted and the satisfaction of employer and employees with the program will be assessed. Discussion This study provides information on the effectiveness of the POSE program on sustained employment. When the program proves to be effective, employees benefit by improved work ability, and health. Employers benefit

Improving Youth Employment Policies in Francophone Africa | IDRC ...

International Development Research Centre (IDRC) Digital Library (Canada)

Africa's persistent job crisis calls for more effective employment policies, including training programs and support for job searches. This project will address the crisis through recommendations that will improve employment policies in francophone Africa. Youth employment initiatives in Africa Over the last two decades, ...

Getting better at chronic care in remote communities: study protocol for a pragmatic cluster randomised controlled of community based management

Directory of Open Access Journals (Sweden)

Schmidt Barbara

2012-11-01

Full Text Available Abstract Background Prevalence and incidence of diabetes and other common comorbid conditions (hypertension, coronary heart disease, renal disease and chronic lung disease are extremely high among Indigenous Australians. Recent measures to improve quality of preventive care in Indigenous community settings, while apparently successful at increasing screening and routine check-up rates, have shown only modest or little improvements in appropriate care such as the introduction of insulin and other scaled-up drug regimens in line with evidence-based guidelines, together with support for risk factor reduction. A new strategy is required to ensure high quality integrated family-centred care is available locally, with continuity and cultural safety, by community-based care coordinators with appropriate system supports. Methods/design The trial design is open parallel cluster randomised controlled trial. The objective of this pragmatic trial is to test the effectiveness of a model of health service delivery that facilitates integrated community-based, intensive chronic condition management, compared with usual care, in rural and remote Indigenous primary health care services in north Queensland. Participants are Indigenous adults (aged 18–65 years with poorly controlled diabetes (HbA1c>=8.5 and at least one other chronic condition. The intervention is to employ an Indigenous Health Worker to case manage the care of a maximum caseload of 30 participants. The Indigenous Health Workers receive intensive clinical training initially, and throughout the study, to ensure they are competent to coordinate care for people with chronic conditions. The Indigenous Health Workers, supported by the local primary health care (PHC team and an Indigenous Clinical Support Team, will manage care, including coordinating access to multidisciplinary team care based on best practice standards. Allocation by cluster to the intervention and control groups is by simple

Randomized Trial of Supported Employment Integrated With Assertive Community Treatment for Rural Adults With Severe Mental Illness

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Gold, Paul B; Meisler, Neil; Santos, Alberto B; Carnemolla, Mark A; Williams, Olivia H; Keleher, Jennie

2006-01-01

Urban-based randomized clinical trials of integrated supported employment (SE) and mental health services in the United States on average have doubled the employment rates of adults with severe mental illness (SMI) compared to traditional vocational rehabilitation. However, studies have not yet explored if the service integrative functions of SE will be effective in coordinating rural-based services that are limited, loosely linked, and geographically dispersed. In addition, SE's ability to replicate the work outcomes of urban programs in rural economies with scarce and less diverse job opportunities remains unknown. In a rural South Carolina county, we designed and implemented a program blending Assertive Community Treatment (ACT) with an SE model, Individual Placement and Support (IPS). The ACT-IPS program operated with ACT and IPS subteams that tightly integrated vocational with mental health services within each self-contained team. In a 24-month randomized clinical trial, we compared ACT-IPS to a traditional program providing parallel vocational and mental health services on competitive work outcomes for adults with SMI (N = 143; 69% schizophrenia, 77% African American). More ACT-IPS participants held competitive jobs (64 versus 26%; p < .001, effect size [ES] = 0.38) and earned more income (median [Mdn] = $549, interquartile range [IQR] = $0–$5,145, versus Mdn = $0, IQR = $0–$40; p < .001, ES = 0.70) than comparison participants. The competitive work outcomes of this rural ACT-IPS program closely resemble those of urban SE programs. However, achieving economic self-sufficiently and developing careers probably require increasing access to higher education and jobs imparting marketable technical skills. PMID:16177278

Education and coronary heart disease: mendelian randomisation study.

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Tillmann, Taavi; Vaucher, Julien; Okbay, Aysu; Pikhart, Hynek; Peasey, Anne; Kubinova, Ruzena; Pajak, Andrzej; Tamosiunas, Abdonas; Malyutina, Sofia; Hartwig, Fernando Pires; Fischer, Krista; Veronesi, Giovanni; Palmer, Tom; Bowden, Jack; Davey Smith, George; Bobak, Martin; Holmes, Michael V

2017-08-30

Objective  To determine whether educational attainment is a causal risk factor in the development of coronary heart disease. Design  Mendelian randomisation study, using genetic data as proxies for education to minimise confounding. Setting  The main analysis used genetic data from two large consortia (CARDIoGRAMplusC4D and SSGAC), comprising 112 studies from predominantly high income countries. Findings from mendelian randomisation analyses were then compared against results from traditional observational studies (164 170 participants). Finally, genetic data from six additional consortia were analysed to investigate whether longer education can causally alter the common cardiovascular risk factors. Participants  The main analysis was of 543 733 men and women (from CARDIoGRAMplusC4D and SSGAC), predominantly of European origin. Exposure  A one standard deviation increase in the genetic predisposition towards higher education (3.6 years of additional schooling), measured by 162 genetic variants that have been previously associated with education. Main outcome measure  Combined fatal and non-fatal coronary heart disease (63 746 events in CARDIoGRAMplusC4D). Results  Genetic predisposition towards 3.6 years of additional education was associated with a one third lower risk of coronary heart disease (odds ratio 0.67, 95% confidence interval 0.59 to 0.77; P=3×10 -8 ). This was comparable to findings from traditional observational studies (prevalence odds ratio 0.73, 0.68 to 0.78; incidence odds ratio 0.80, 0.76 to 0.83). Sensitivity analyses were consistent with a causal interpretation in which major bias from genetic pleiotropy was unlikely, although this remains an untestable possibility. Genetic predisposition towards longer education was additionally associated with less smoking, lower body mass index, and a favourable blood lipid profile. Conclusions  This mendelian randomisation study found support for the hypothesis that low education is a causal risk

Adjusting for multiple prognostic factors in the analysis of randomised trials

Science.gov (United States)

2013-01-01

Background When multiple prognostic factors are adjusted for in the analysis of a randomised trial, it is unclear (1) whether it is necessary to account for each of the strata, formed by all combinations of the prognostic factors (stratified analysis), when randomisation has been balanced within each stratum (stratified randomisation), or whether adjusting for the main effects alone will suffice, and (2) the best method of adjustment in terms of type I error rate and power, irrespective of the randomisation method. Methods We used simulation to (1) determine if a stratified analysis is necessary after stratified randomisation, and (2) to compare different methods of adjustment in terms of power and type I error rate. We considered the following methods of analysis: adjusting for covariates in a regression model, adjusting for each stratum using either fixed or random effects, and Mantel-Haenszel or a stratified Cox model depending on outcome. Results Stratified analysis is required after stratified randomisation to maintain correct type I error rates when (a) there are strong interactions between prognostic factors, and (b) there are approximately equal number of patients in each stratum. However, simulations based on real trial data found that type I error rates were unaffected by the method of analysis (stratified vs unstratified), indicating these conditions were not met in real datasets. Comparison of different analysis methods found that with small sample sizes and a binary or time-to-event outcome, most analysis methods lead to either inflated type I error rates or a reduction in power; the lone exception was a stratified analysis using random effects for strata, which gave nominal type I error rates and adequate power. Conclusions It is unlikely that a stratified analysis is necessary after stratified randomisation except in extreme scenarios. Therefore, the method of analysis (accounting for the strata, or adjusting only for the covariates) will not

Energy intake and sources of nutritional support in patients with head and neck cancer--a randomised longitudinal study.

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Silander, E; Jacobsson, I; Bertéus-Forslund, H; Hammerlid, E

2013-01-01

Malnutrition decreases the cancer patient's ability to manage treatment, affects quality of life and survival, and is common among head and neck (HN) cancer patients due to the tumour location and the treatment received. In this study, advanced HN cancer patients were included and followed during 2 years in order to measure their energy intake, choice of energy sources and to assess problems with dysphagia. The main purpose was to explore when and for how long the patients had dysphagia and lost weight due to insufficient intake and if having a PEG (percutaneous endoscopic gastrostomy) in place for enteral nutrition made a difference. One hundred thirty-four patients were included and randomised to either a prophylactic PEG for early enteral feeding or nutritional care according to clinical praxis. At seven time points weight, dysphagia and energy intake (assessed as oral, nutritional supplements, enteral and parenteral) were measured. Both groups lost weight the first six months due to insufficient energy intake and used enteral nutrition as their main intake source; no significant differences between groups were found. Problems with dysphagia were vast during the 6 months. At the 6-, 12- and 24-month follow-ups both groups reached estimated energy requirements and weight loss ceased. Oral intake was the major energy source after 1 year. HN cancer patients need nutritional support and enteral feeding for a long time period during and after treatment due to insufficient energy intake. A prophylactic PEG did not significantly improve the enteral intake probably due to treatment side effects.

Workplace Training: Employer and Employee Perspectives

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National Centre for Vocational Education Research (NCVER), 2017

2017-01-01

According to the 2016 Organisation for Economic Co-operation and Development (OECD) report, Education at a glance, much of the learning at work takes place through employer-supported training. Both employers and employees recognise the benefits of such training because skilling the workforce can lead to better jobs, greater firm competitiveness,…

Improving social functioning and reducing social isolation and loneliness among people with enduring mental illness: Report of a randomised controlled trial of supported socialisation.

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Sheridan, Ann J; Drennan, Jonathan; Coughlan, Barbara; O'Keeffe, Donal; Frazer, Kate; Kemple, Mary; Alexander, Denise; Howlin, Frances; Fahy, Anne; Kow, Veronica; O'Callaghan, Eadbhard

2015-05-01

This randomised controlled trial examined if for people with enduring mental illness, being supported to socialise leads to improved social functioning, increased self-esteem and extended social networks; a reduction in social isolation, social, emotional and family loneliness and a reduction in illness symptoms, namely depression. A prospective randomised controlled trial was undertaken from November 2007 to September 2011. Service users with a diagnosis of enduring mental illness (>18 years) were invited to participate. Participants were randomly allocated to intervention or control group conditions in a 1:1 ratio. Intervention group participants were matched with a volunteer partner, asked to engage in social/leisure activities for 2 hours weekly over a 9-month period, and received a €20 stipend monthly. Control group participants received a €20 monthly stipend and were asked to engage in a weekly social/leisure activity. Social functioning, the primary outcome, was measured using the Social Functioning Scale (SFS) at three time points (baseline, midpoint and endpoint). In all, 107 people completed this study. There were no significant differences between control and intervention groups at the commencement of the intervention on demographic characteristics or the main outcome measures of interest. Overall social functioning positively changed throughout the three time points from a mean of 99·7 (standard deviation (SD) = 15.1) at baseline, to a mean of 106.0 (SD = 27.0) at the endpoint for the control group, and from a mean of 100·4 (SD = 15.0) at Time 1 for the intervention group, to a mean of 104.1 (SD = 23.4) at the endpoint for the intervention group. The intervention showed no statistical differences between the control and intervention groups on primary or secondary outcome measures. The stipend and the stipend plus volunteer partner led to an increase in recreational social functioning; a decrease in levels of social loneliness, in depression and in

Part-Time Higher Education: Employer Engagement under Threat?

Science.gov (United States)

Mason, Geoff

2014-01-01

Employer support for employees who are studying part-time for higher education qualifications constitutes a form of indirect employer engagement with higher education institutions that has contributed strongly to the development of work-related skills and knowledge over the years. However, this form of employer engagement with higher education…

Early retirement and non-employment after breast cancer

DEFF Research Database (Denmark)

Lindbohm, M-L; Kuosma, E; Taskila, T

2014-01-01

This study examined whether workplace support, sociodemographic factors and co-morbidity are associated with early retirement or non-employment due to other reasons among breast cancer survivors. We also compared quality of life and chronic symptoms (pain, fatigue, anxiety and depression) among...... employed, retired and other non-employed breast cancer survivors....

Effectiveness and cost of recruitment strategies for a community-based randomised controlled trial among rainwater drinkers

Directory of Open Access Journals (Sweden)

Cunliffe David

2009-07-01

Full Text Available Abstract Background Community-based recruitment is challenging particularly if the sampling frame is not easily defined as in the case of people who drink rainwater. Strategies for contacting participants must be carefully considered to maximise generalisability and minimise bias of the results. This paper assesses the recruitment strategies for a 1-year double-blinded randomised trial on drinking untreated rainwater. The effectiveness of the recruitment strategies and associated costs are described. Methods Community recruitment of households from Adelaide, Australia occurred from February to July 2007 using four methods: electoral roll mail-out, approaches to schools and community groups, newspaper advertising, and other media involvement. Word of mouth communication was also assessed. Results A total of 810 callers were screened, with 53.5% eligible. Of those who were eligible and sent further information, 76.7% were willing to participate in the study and 75.1% were enrolled. The target for recruitment was 300 households, and this was achieved. The mail-out was the most effective method with respect to number of households randomised, while recruitment via schools had the highest yield (57.3% and was the most cost effective when considering cost per household randomised (AUD$147.20. Yield and cost effectiveness were lowest for media advertising. Conclusion The use of electoral roll mail-out and advertising via schools were effective in reaching households using untreated rainwater for drinking. Employing multiple strategies enabled success in achieving the recruitment target. In countries where electoral roll extracts are available to researchers, this method is likely to have a high yield for recruitment into community-based epidemiological studies.

Systematic reviews of randomised clinical trials examining the effects of psychotherapeutic interventions versus "no intervention" for acute major depressive disorder and a randomised trial examining the effects of "third wave" cognitive therapy versus mentalization-based treatment for acute major depressive disorder.

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Jakobsen, Janus Christian

2014-10-01

Major depressive disorder afflicts an estimated 17% of individuals during their lifetimes at tremendous suffering and costs. Cognitive therapy and psychodynamic therapy may be effective treatment options for major depressive disorder, but the effects have only had limited assessment in systematic reviews. The two modern forms of psychotherapy, "third wave" cognitive therapy and mentalization-based treatment, have both gained some ground as treatments of psychiatric disorders. No randomised trial has compared the effects of these two interventions for major depressive disorder. We performed two systematic reviews with meta-analyses and trial sequential analyses using The Cochrane Collaboration methodology examining the effects of cognitive therapy and psycho-dynamic therapy for major depressive disorder. We developed a thorough treatment protocol for a randomised trial with low risks of bias (systematic error) and low risks of random errors ("play of chance") examining the effects of third wave' cognitive therapy versus mentalization-based treatment for major depressive disorder. We conducted a randomised trial according to good clinical practice examining the effects of "third wave" cognitive therapy versus mentalisation-based treatment for major depressive disorder. The first systematic review included five randomised trials examining the effects of psychodynamic therapy versus "no intervention' for major depressive disorder. Altogether the five trials randomised 365 participants who in each trial received similar antidepressants as co-interventions. All trials had high risk of bias. Four trials assessed "interpersonal psychotherapy" and one trial "short psychodynamic supportive psychotherapy". Both of these interventions are different forms of psychodynamic therapy. Meta-analysis showed that psychodynamic therapy significantly reduced depressive symptoms on the Hamilton Depression Rating Scale (HDRS) compared with "no intervention" (mean difference -3.01 (95

Efficacy and safety of renal denervation for Chinese patients with resistant hypertension using a microirrigated catheter: study design and protocol for a prospective multicentre randomised controlled trial.

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Liu, Zongjun; Shen, Li; Huang, Weijian; Zhao, Xianxian; Fang, Weiyi; Wang, Changqian; Yin, Zhaofang; Wang, Jianan; Fu, Guosheng; Liu, Xuebo; Jiang, Jianjun; Zhang, Zhihui; Li, Jingbo; Lu, Yingmin; Ge, Junbo

2017-09-01

Available data show that approximately 8%-18% of patients with primary hypertension will develop resistant hypertension. In recent years, catheter-based renal denervation (RDN) has emerged as a potential treatment option for resistant hypertension. A number of observational studies and randomised controlled trials among non-Chinese patients have demonstrated its potential safety and efficacy. This is a multicentre, randomised, open-label, parallel-group, active controlled trial that will investigate the efficacy and safety of a 5F saline-irrigated radiofrequency ablation (RFA) used for RDN in the treatment of Chinese patients with resistant hypertension. A total of 254 patients who have failed pharmacological therapy will be enrolled. Eligible subjects will be randomised in a 1:1 ratio to undergo RDN using the RFA plus antihypertensive medication or to receive treatment with antihypertensive medication alone. The primary outcome measure is the change in 24 hours average ambulatory systolic blood pressure from baseline to 3 months, comparing the RDN-plus-medication group with the medication-alone group. Important secondary endpoints include the change in office blood pressure from baseline to 6 months after randomisation. Safety endpoints such as changes in renal function will also be evaluated. The full analysis set, according to the intent-to-treat principle, will be established as the primary analysis population. All participants will provide informed consent; the study protocol has been approved by the Independent Ethics Committee for each site. This study is designed to investigate the efficacy and safety of RDN using a 5F saline microirrigated RFA. Findings will be shared with participating hospitals, policymakers and the academic community to promote the clinical management of resistant hypertension in China. ClinicalTrials.gov ID: NCT02900729; pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017

Utilising advance care planning videos to empower perioperative cancer patients and families: a study protocol of a randomised controlled trial.

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Aslakson, Rebecca A; Isenberg, Sarina R; Crossnohere, Norah L; Conca-Cheng, Alison M; Yang, Ting; Weiss, Matthew; Volandes, Angelo E; Bridges, John F P; Roter, Debra L

2017-06-06

Despite positive health outcomes associated with advance care planning (ACP), little research has investigated the impact of ACP in surgical populations. Our goal is to evaluate how an ACP intervention video impacts the patient centredness and ACP of the patient-surgeon conversation during the presurgical consent visit. We hypothesise that patients who view the intervention will engage in a more patient-centred communication with their surgeons compared with patients who view a control video. Randomised controlled superiority trial of an ACP video with two study arms (intervention ACP video and control video) and four visits (baseline, presurgical consent, postoperative 1 week and postoperative 1 month). Surgeons, patients, principal investigator and analysts are blinded to the randomisation assignment. Single, academic, inner city and tertiary care hospital. Data collection began July 16, 2015 and continues to March 2017. Patients recruited from nine surgical oncology clinics who are undergoing major cancer surgery. In the intervention arm, patients view a patient preparedness video developed through extensive engagement with patients, surgeons and other stakeholders. Patients randomised to the control arm viewed an informational video about the hospital surgical programme. Primary Outcome: Patient centredness and ACP of patient-surgeon conversations during the presurgical consent visit as measured through the Roter Interaction Analysis System. patient Hospital Anxiety and Depression Scale score; patient goals of care; patient, companion and surgeon satisfaction; video helpfulness; medical decision maker designation; and the frequency patients watch the video. Intent-to-treat analysis will be used to assess the impact of video assignment on outcomes. Sensitivity analyses will assess whether there are differential effects contingent on patient or surgeon characteristics. This study has been approved by the Johns Hopkins School of Medicine institutional review

Lovastatin for adult patients with dengue: protocol for a randomised controlled trial

Science.gov (United States)

2012-01-01

Background Dengue is the most important vector-borne viral infection of man, with approximately 2 billion people living in areas at risk. Infection results in a range of manifestations from asymptomatic infection through to life-threatening shock and haemorrhage. One of the hallmarks of severe dengue is vascular endothelial disruption. There is currently no specific therapy and clinical management is limited to supportive care. Statins are a class of drug initially developed for lipid lowering. There has been considerable recent interest in their effects beyond lipid lowering. These include anti-inflammatory effects at the endothelium. In addition, it is possible that lovastatin may have an anti-viral effect against dengue. Observational data suggest that the use of statins may improve outcomes for such conditions as sepsis and pneumonia. This paper describes the protocol for a randomised controlled trial investigating a short course of lovastatin therapy in adult patients with dengue. Methods/design A randomised, double-blind, placebo-controlled trial will investigate the effects of lovastatin therapy in the treatment of dengue. The trial will be conducted in two phases with an escalation of dose between phases if an interim safety review is satisfactory. This is an exploratory study focusing on safety and there are no data on which to base a sample size calculation. A target sample size of 300 patients in the second phase, enrolled over two dengue seasons, was chosen based on clinical judgement and feasibility considerations. In a previous randomised trial in dengue, about 10% and 30% of patients experienced at least one serious adverse event or adverse event, respectively. With 300 patients, we will have 80% power to detect an increase of 12% (from 10% to 22%) or 16% (from 30% to 46%) in the frequency of adverse events. Furthermore, this sample size ensures some power to explore the efficacy of statins. Discussion The development of a dengue therapeutic that can

Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial.

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Li, Jin; Qin, Shukui; Xu, Ruihua; Yau, Thomas C C; Ma, Brigette; Pan, Hongming; Xu, Jianming; Bai, Yuxian; Chi, Yihebali; Wang, Liwei; Yeh, Kun-Huei; Bi, Feng; Cheng, Ying; Le, Anh Tuan; Lin, Jen-Kou; Liu, Tianshu; Ma, Dong; Kappeler, Christian; Kalmus, Joachim; Kim, Tae Won

2015-06-01

In the international randomised phase 3 CORRECT trial (NCT01103323), regorafenib significantly improved overall survival versus placebo in patients with treatment-refractory metastatic colorectal cancer. Of the 760 patients in CORRECT, 111 were Asian (mostly Japanese). This phase 3 trial was done to assess regorafenib in a broader population of Asian patients with refractory metastatic colorectal cancer than was studied in CORRECT. In this randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial done in 25 hospitals in mainland China, Hong Kong, South Korea, Taiwan, and Vietnam, we recruited Asian patients aged 18 years or older with progressive metastatic colorectal cancer who had received at least two previous treatment lines or were unable to tolerate standard treatments. Patients had to have an Eastern Cooperative Oncology Group performance status of 0 or 1, life expectancy of at least 3 months, and adequate bone marrow, liver, and renal function, without other uncontrolled medical disorders. We randomly allocated patients (2:1; with a computer-generated unicentric randomisation list [prepared by the study funder] and interactive voice response system; block size of six; stratified by metastatic site [single vs multiple organs] and time from diagnosis of metastatic disease [regorafenib 160 mg once daily or placebo on days 1-21 of each 28 day cycle; patients in both groups were also to receive best supportive care. Participants, investigators, and the study funder were masked to treatment assignment. The primary endpoint was overall survival, and we analysed data on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT01584830. Between April 29, 2012, and Feb 6, 2013, we screened 243 patients and randomly assigned 204 patients to receive either regorafenib (136 [67%]) or placebo (68 [33%]). After a median follow-up of 7·4 months (IQR 4·3-12·2), overall survival was significantly better with regorafenib

Exploring example models of cross-sector, sessional employment of pharmacists to improve medication management and pharmacy support in rural hospitals.

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Tan, Amy Cw; Emmerton, Lynne M; Hattingh, Laetitia; La Caze, Adam

2015-01-01

Many rural hospitals in Australia are not large enough to sustain employment of a full-time pharmacist, or are unable to recruit or retain a full-time pharmacist. The absence of a pharmacist may result in hospital nurses undertaking medication-related roles outside their scope of practice. A potential solution to address rural hospitals' medication management needs is contracted part-time ('sessional') employment of a local pharmacist external to the hospital ('cross-sector'). The aim of this study was to explore the roles and experiences of pharmacists in their provision of sessional services to rural hospitals with no on-site pharmacist and explore how these roles could potentially address shortfalls in medication management in rural hospitals. A qualitative study was conducted to explore models with pharmacists who had provided sessional services to a rural hospital. A semi-structured interview guide was informed by a literature review, preliminary research and stakeholder consultation. Participants were recruited via advertisement and personal contacts. Consenting pharmacists were interviewed between August 2012 and January 2013 via telephone or Skype for 40-55 minutes. Thirteen pharmacists with previous or ongoing hospital sessional contracts in rural communities across Australia and New Zealand participated. Most commonly, the pharmacists provided weekly services to rural hospitals. All believed the sessional model was a practical solution to increase hospital access to pharmacist-mediated support and to address medication management gaps. Roles perceived to promote quality use of medicines were inpatient consultation services, medicines information/education to hospital staff, assistance with accreditation matters and system reviews, and input into pharmaceutical distribution activities. This study is the first to explore the concept of sessional rural hospital employment undertaken by pharmacists in Australia and New Zealand. Insights from participants

Protocol for extended antibiotic therapy after laparoscopic cholecystectomy for acute calculous cholecystitis (Cholecystectomy Antibiotic Randomised Trial, CHART).

Science.gov (United States)

Pellegrini, Pablo; Campana, Juan Pablo; Dietrich, Agustín; Goransky, Jeremías; Glinka, Juan; Giunta, Diego; Barcan, Laura; Alvarez, Fernando; Mazza, Oscar; Sánchez Claria, Rodrigo; Palavecino, Martin; Arbues, Guillermo; Ardiles, Victoria; de Santibañes, Eduardo; Pekolj, Juan; de Santibañes, Martin

2015-11-18

Acute calculous cholecystitis represents one of the most common complications of cholelithiasis. While laparoscopic cholecystectomy is the standard treatment in mild and moderate forms, the need for antibiotic therapy after surgery remains undefined. The aim of the randomised controlled Cholecystectomy Antibiotic Randomised Trial (CHART) is therefore to assess if there are benefits in the use of postoperative antibiotics in patients with mild or moderate acute cholecystitis in whom a laparoscopic cholecystectomy is performed. A single-centre, double-blind, randomised trial. After screening for eligibility and informed consent, 300 patients admitted for acute calculus cholecystitis will be randomised into two groups of treatment, either receiving amoxicillin/clavulanic acid or placebo for 5 consecutive days. Postoperative evaluation will take place during the first 30 days. Postoperative infectious complications are the primary end point. Secondary end points are length of hospital stay, readmissions, need of reintervention (percutaneous or surgical reinterventions) and overall mortality. The results of this trial will provide strong evidence to either support or abandon the use of antibiotics after surgery, impacting directly in the incidence of adverse events associated with the use of antibiotics, the emergence of bacterial resistance and treatment costs. This study and informed consent sheets have been approved by the Research Projects Evaluating Committee (CEPI) of Hospital Italiano de Buenos Aires (protocol N° 2111). The results of the trial will be reported in a peer-reviewed publication. NCT02057679. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Homeopathy for Perennial Asthma in Adolescents: Pilot Feasibility Study Testing a Randomised Withdrawal Design.

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Mitchiguian Hotta, Livia; Cardinalli Adler, Ubiratan; de Toledo Cesar, Amarilys; Martinez, Edson Zangiacomi; Demarzo, Marcelo Marcos Piva

2018-05-01

 Previous findings from a pragmatic trial suggest that usual care compared with usual care plus individualised homeopathy is not a feasible design to address homeopathic interventions for asthma.  The main purpose of this article was to investigate the feasibility of the randomised withdrawal design as a strategy to assess the effectiveness of a standardised clinical-pharmaceutical homeopathic protocol ( Organon.modus ) on perennial asthma in adolescents.  Randomised withdrawal, double-blind, parallel, placebo-controlled, 12-week study. 12 to 17 years old adolescents, with the diagnosis of perennial asthma, using inhalatory beclomethasone (plus fenoterol for wheezing episodes), who achieved 3 months of well-controlled asthma, after a variable period of individualised homeopathic treatment according to Organon.modus protocol. a secondary care medical specialist centre. continuation with the individualised homeopathic medicine or with indistinguishable placebo during 12 weeks of beclomethasone step-down. number of days of well-controlled asthma. Secondary measures: number of days of fenoterol use, number of visits to an emergency service (without hospitalisation) and percentage of patients excluded due to an exacerbation characterising a partly controlled asthma. Tolerability was assessed by Adverse Events, registered at every visit.  Nineteen patients were randomised to continue treatment with homeopathy and 21 with placebo. Effectiveness measures for the homeopathy and placebo groups respectively were median number of days of good clinical control: 84 versus 30 ( p  = 0.18); median number of days of fenoterol use per patient: 3 versus 5 ( p  = 0.41); visits to an emergency room: 1 versus 6 ( p  = 0.35); percentage of exclusion due to partly controlled asthma: 36.8% versus 71.4% ( p  = 0.05). Few Adverse Events were reported.  This pilot study supports the feasibility of the double-blind randomised withdrawal design in studies investigating

Maternal employment and birth outcomes

DEFF Research Database (Denmark)

Wüst, Miriam

selection of mothers between pregnancies drives the results, I focus on mothers whose change in employment status is likely not to be driven by underlying health (unemployed mothers and students). Given generous welfare bene ts and strict workplace regulations in Denmark, my findings support a residual......I use Danish survey and administrative data to examine the impact of maternal employment during pregnancy on birth outcomes. As healthier mothers are more likely to work and health shocks to mothers may impact employment and birth outcomes, I combine two strategies: First, I control extensively...... for time-varying factors that may correlate with employment and birth outcomes, such as pre-pregnancy family income and maternal occupation, pregnancy-related health shocks, maternal sick listing, and health behaviors (smoking and alcohol consumption). Second, to account for remaining time...

Improving the implementation of responsible alcohol management practices by community sporting clubs: A randomised controlled trial.

Science.gov (United States)

Kingsland, Melanie; Wolfenden, Luke; Tindall, Jennifer; Rowland, Bosco; Sidey, Maree; McElduff, Patrick; Wiggers, John H

2015-07-01

Despite an increased prevalence of risky alcohol consumption and alcohol-related harm among members of sporting groups and at sporting venues, sporting clubs frequently fail to implement alcohol management practices consistent with liquor legislation and best practice guidelines. The aim of this study was to assess the impact of a multi-strategy intervention in improving the implementation of responsible alcohol management practices by sports clubs. A randomised controlled trial was conducted with 87 football clubs, with half randomised to receive a multi-strategy intervention to support clubs to implement responsible alcohol management practices. The 2-year intervention, which was based on implementation and capacity building theory and frameworks, included project officer support, funding, accreditation rewards, printed resources, observational audit feedback, newsletters, training and support from state sporting organisations. Interviews were undertaken with club presidents at baseline and post-intervention to assess alcohol management practice implementation. Post-intervention, 88% of intervention clubs reported implementing '13 or more' of 16 responsible alcohol management practices, which was significantly greater than the proportion of control groups reporting this level of implementation (65%) [odds ratio: 3.7 (95% confidence interval: 1.1-13.2); P = 0.04]. All intervention components were considered highly useful and three-quarters or more of clubs rated the amount of implementation support to be sufficient. The multi-strategy intervention was successful in improving alcohol management practices in community sports clubs. Further research is required to better understand implementation barriers and to assess the long-term sustainability of the change in club alcohol management practices. © 2015 Australasian Professional Society on Alcohol and other Drugs.

Implementing a complex intervention to support personal recovery: a qualitative study nested within a cluster randomised controlled trial.

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Leamy, Mary; Clarke, Eleanor; Le Boutillier, Clair; Bird, Victoria; Janosik, Monika; Sabas, Kai; Riley, Genevieve; Williams, Julie; Slade, Mike

2014-01-01

To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams. Process evaluation nested within a cluster randomised controlled trial (RCT). 28 interviews with mental health care staff, 3 interviews with trainers, 4 focus groups with intervention teams and 28 written trainer reports. 14 community-based mental health teams in two UK sites (one urban, one semi-rural) who received the intervention. The factors influencing the implementation of the intervention can be organised under two over-arching themes: Organisational readiness for change and Training effectiveness. Organisational readiness for change comprised three sub-themes: NHS Trust readiness; Team readiness; and Practitioner readiness. Training effectiveness comprised three sub-themes: Engagement strategies; Delivery style and Modelling recovery principles. Three findings can inform future implementation and evaluation of complex interventions. First, the underlying intervention model predicted that three areas would be important for changing practice: staff skill development; intention to implement; and actual implementation behaviour. This study highlighted the importance of targeting the transition from practitioners' intent to implement to actual implementation behaviour, using experiential learning and target setting. Second, practitioners make inferences about organisational commitment by observing the allocation of resources, Knowledge Performance Indicators and service evaluation outcome measures. These need to be aligned with recovery values, principles and practice. Finally, we recommend the use of organisational readiness tools as an inclusion criteria for selecting both organisations and teams in cluster RCTs. We believe this would maximise the likelihood of adequate implementation and hence reduce waste in research

Supporting Second Chances: Education and Employment Strategies For People Returning from Correctional Facilities

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Jobs For the Future, 2015

2015-01-01

This brief highlights strategies for strengthening education and employment pathways for youth and adults returning from correctional facilities and notes key questions that new research should answer. It also explores barriers to employment for people with criminal records--whether or not they have been incarcerated--and potential policy…

Pilot randomised controlled trial of the ENGAGER collaborative care intervention for prisoners with common mental health problems, near to and after release.

Science.gov (United States)

Lennox, Charlotte; Kirkpatrick, Tim; Taylor, Rod S; Todd, Roxanne; Greenwood, Clare; Haddad, Mark; Stevenson, Caroline; Stewart, Amy; Shenton, Deborah; Carroll, Lauren; Brand, Sarah L; Quinn, Cath; Anderson, Rob; Maguire, Mike; Harris, Tirril; Shaw, Jennifer; Byng, Richard

2018-01-01

Rates of common mental health problems are much higher in prison populations, but access to primary care mental health support falls short of community equivalence. Discontinuity of care on release is the norm and is further complicated by substance use and a range of social problems, e.g. homelessness. To address these problems, we worked with criminal justice, third sector social inclusion services, health services and people with lived experiences (peer researchers), to develop a complex collaborative care intervention aimed at supporting men with common mental health problems near to and following release from prison. This paper describes an external pilot trial to test the feasibility of a full randomised controlled trial. Eligible individuals with 4 to 16 weeks left to serve were screened to assess for common mental health problems. Participants were then randomised at a ratio of 2:1 allocation to ENGAGER plus standard care (intervention) or standard care alone (treatment as usual). Participants were followed up at 1 and 3 months' post release. Success criteria for this pilot trial were to meet the recruitment target sample size of 60 participants, to follow up at least 50% of participants at 3 months' post release from prison, and to deliver the ENGAGER intervention. Estimates of recruitment and retention rates and 95% confidence intervals (CIs) are reported. Descriptive analyses included summaries (percentages or means) for participant demographics, and baseline characteristics are reported. Recruitment target was met with 60 participants randomised in 9 months. The average retention rates were 73% at 1 month [95% CI 61 to 83] and 47% at 3 months follow-up [95% CI 35 to 59]. Ninety percent of participants allocated to the intervention successfully engaged with a practitioner before release and 70% engaged following release. This pilot confirms the feasibility of conducting a randomised trial for prison leavers with common mental health problems. Based

Does recruitment source moderate treatment effectiveness? A subgroup analysis from the EVIDENT study, a randomised controlled trial of an internet intervention for depressive symptoms.

Science.gov (United States)

Klein, Jan Philipp; Gamon, Carla; Späth, Christina; Berger, Thomas; Meyer, Björn; Hohagen, Fritz; Hautzinger, Martin; Lutz, Wolfgang; Vettorazzi, Eik; Moritz, Steffen; Schröder, Johanna

2017-07-13

This study aims to examine whether the effects of internet interventions for depression generalise to participants recruited in clinical settings. This study uses subgroup analysis of the results of a randomised, controlled, single-blind trial. The study takes place in five diagnostic centres in Germany. A total of 1013 people with mild to moderate depressive symptoms were recruited from clinical sources as well as internet forums, statutory insurance companies and other sources. This study uses either care-as-usual alone (control) or a 12-week internet intervention (Deprexis) plus usual care (intervention). The primary outcome measure was self-rated depression severity (Patient Health Questionnaire-9) at 3 months and 6 months. Further measures ranged from demographic and clinical parameters to a measure of attitudes towards internet interventions (Attitudes towards Psychological Online Interventions Questionnaire). The recruitment source was only associated with very few of the examined demographic and clinical characteristics. Compared with participants recruited from clinical sources, participants recruited through insurance companies were more likely to be employed. Clinically recruited participants were as severely affected as those from other recruitment sources but more sceptical of internet interventions. The effectiveness of the intervention was not differentially associated with recruitment source (treatment by recruitment source interaction=0.28, p=0.84). Our results support the hypothesis that the intervention we studied is effective across different recruitment sources including clinical settings. ClinicalTrials.gov NCT01636752. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Using the Social Enterprise Intervention (SEI) and Individual Placement and Support (IPS) models to improve employment and clinical outcomes of homeless youth with mental illness.

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Ferguson, Kristin M

2013-09-01

Prior research reveals high unemployment rates among homeless youth. The literature offers many examples of using evidence-informed and evidence-based supported employment models with vulnerable populations to assist them in obtaining and maintaining employment and concurrently addressing mental health challenges. However, there are few examples to date of these models with homeless youth with mental illness. The purpose of this article was thus to describe a methodology for establishing a university-agency research partnership to design, implement, evaluate, and replicate evidence-informed and evidence-based interventions with homeless youth with mental illness to enhance their employment, mental health, and functional outcomes. Data from two studies are used to illustrate the relationship between vocational skill-building/employment and mental health among homeless youth. The article concludes with a discussion of the implications of conducting community-based participatory employment and clinical intervention research. The author highlights the opportunities and tensions associated with this approach.

The Purposefulness and Effectiveness of Supporting Entrepreneurship with Public Funds – EU Funds for the Development of Self-Employment and Startups

Directory of Open Access Journals (Sweden)

Dominika Wojtowicz

2013-12-01

Full Text Available Purpose: The paper discusses issues associated with using funds that support the development of entrepreneurship – the purpose of the paper is to answer questions regarding the purposefulness and effectiveness of financial instruments from EU funds aimed at the development of emerging businesses (startups. Methodology: The paper analyzes previously conducted research studies in the fi eld of the discussed topic, it systematizes and describes the fi nancial instruments from EU funds supporting self- employment and startups in their early stages of activity. It also provides an overview of evaluation reports concerning these instruments. The paper also contains a case study: an analysis of the effectiveness of a selected project supporting the development of entrepreneurship (co-fi nanced from EU funds, in which the method of evaluating the net effect of the support in the short term has been used. Findings: An analysis of previously conducted research studies has shown that properly designed State aid targeted at those starting up their own business is sensible, as it provides them with seed capital and it helps them survive the most diffi cult period of the so-called “startup”. However, there is a lack of comprehensive studies to confirm the positive impact of business support interventions carried out using EU funds. The methodology of evaluating the net effect used by the Author in the conducted study has made it possible to identify the actual size of the – positive – impact of the selected project on the growth of self-employment. Limitations: The study revealed some limitations – the method and time of the study allow to capture the phenomenon on a micro-scale, in the short term. The institutions that are involved in the process of allocating funds should develop a comprehensive methodology that implements the idea of evaluating the net effect, allowing to assess the effectiveness of the support at regional and national level

Integrating Fieldwork into Employment Counseling for Methadone-Treatment Patients

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Blankertz, Laura; Spinelli, Michael; Magura, Stephen; Bali, Priti; Madison, Elizabeth M.; Staines, Graham L.; Horowitz, Emily; Guarino, Honoria; Grandy, Audrey; Fong, Chunki; Gomez, Augustin; Dimun, Amy; Friedman, Ellen

2005-01-01

An innovative employment counseling model, Customized Employment Supports, was developed for methadone-treatment patients, a population with historically low employment rates. The effectiveness of a key component of the model, "vocational fieldwork," the delivery of services in the community rather than only within the clinic, was assessed through…

Return to work among self-employed cancer survivors.

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Torp, Steffen; Syse, Jonn; Paraponaris, Alain; Gudbergsson, Sævar

2017-04-01

The aim of this study is to investigate whether salaried and self-employed workers differ regarding factors relevant for return to work after being diagnosed with cancer. The possible mediators of an effect of self-employment on work ability were also investigated. A total of 1115 cancer survivors (1027 salaried and 88 self-employed) of common invasive cancer types who were in work at the time of diagnosis completed a mailed questionnaire 15-39 months after diagnosis. Twenty-four percent of self-employed cancer survivors reported that they had not returned to work at the time of the survey, and 18 % of those who were salaried had not. While 9 % of the self-employed had received disability or early retirement pension, only 5 % had received such a pension among salaried employees. Compared with the salaried workers, the self-employed people reported significantly more often reduced work hours (P self-employment on total work ability seems to be mediated by reduced work hours and a negative cancer-related financial change. Compared with salaried, self-employed workers in Norway, they seem to struggle with work after cancer. This may be because the two groups have different work tasks and because self-employed people have lower social support at work and less legal support from the Working Environment Act and public health insurance. Self-employed people with cancer should be informed about the work-related challenges they may encounter and be advised to seek practical help from social workers who know about the legal rights of self-employed people.

Provider-identified barriers and facilitators to implementing a supported employment program in spinal cord injury.

Science.gov (United States)

Cotner, Bridget A; Ottomanelli, Lisa; O'Connor, Danielle R; Trainor, John K

2018-06-01

In a 5-year study, individual placement and support (IPS) significantly increased employment rate of United States Veterans with spinal cord injury (SCI), a historically underemployed population. In a follow-up study, data on barriers and facilitators to IPS implementation were identified. Over 24 months of implementation, 82 key medical and vocational staff underwent semi-structured interviews (n = 130). Interviews were digitally recorded and qualitatively analyzed (ATLAS.ti v0.7) using a constant comparative method to generate themes. Some barriers to implementation occurred throughout the study, such as Veterans' lack of motivation and providers' difficulty integrating vocational and medical rehabilitation. Other barriers emerged at specific stages, for example, early barriers included a large geographic service area and a large patient caseload, and late barriers included need for staff education. Facilitators were mostly constant throughout implementation and included leadership support and successful integration of vocational staff into the medical care team. Implementation strategies need to be adjusted as implementation progresses and matures. The strategies that succeeded in this setting, which were situated in a real-world context of providing IPS as a part of SCI medical care, may inform implementation of IPS for other populations with physical disabilities. Implications for Rehabilitation Key facilitators to IPS in SCI implementation are integrating vocational staff with expertise in IPS and SCI on clinical rehabilitation teams and providing leadership support. Ongoing barriers to IPS in SCI include patient specific and program administration factors such as caseload size and staffing patterns. Varying implementation strategies are needed to address barriers as they arise and facilitate successful implementation.

Randomised clinical trial

DEFF Research Database (Denmark)

Coyle, C; Crawford, G; Wilkinson, J

2017-01-01

BACKGROUND: Symptomatic breakthrough in proton pump inhibitor (PPI)-treated gastro-oesophageal reflux disease (GERD) patients is a common problem with a range of underlying causes. The nonsystemic, raft-forming action of alginates may help resolve symptoms. AIM: To assess alginate-antacid (Gaviscon...... Double Action, RB, Slough, UK) as add-on therapy to once-daily PPI for suppression of breakthrough reflux symptoms. METHODS: In two randomised, double-blind studies (exploratory, n=52; confirmatory, n=262), patients taking standard-dose PPI who had breakthrough symptoms, assessed by Heartburn Reflux...

Promoting Recruitment using Information Management Efficiently (PRIME): a stepped-wedge, cluster randomised trial of a complex recruitment intervention embedded within the REstart or Stop Antithrombotics Randomised Trial.

Science.gov (United States)

Maxwell, Amy E; Parker, Richard A; Drever, Jonathan; Rudd, Anthony; Dennis, Martin S; Weir, Christopher J; Al-Shahi Salman, Rustam

2017-12-28

Few interventions are proven to increase recruitment in clinical trials. Recruitment to RESTART, a randomised controlled trial of secondary prevention after stroke due to intracerebral haemorrhage, has been slower than expected. Therefore, we sought to investigate an intervention to boost recruitment to RESTART. We conducted a stepped-wedge, cluster randomised trial of a complex intervention to increase recruitment, embedded within the RESTART trial. The primary objective was to investigate if the PRIME complex intervention (a recruitment co-ordinator who conducts a recruitment review, provides access to bespoke stroke audit data exports, and conducts a follow-up review after 6 months) increases the recruitment rate to RESTART. We included 72 hospital sites located in England, Wales, or Scotland that were active in RESTART in June 2015. All sites began in the control state and were allocated using block randomisation stratified by hospital location (Scotland versus England/Wales) to start the complex intervention in one of 12 different months. The primary outcome was the number of patients randomised into RESTART per month per site. We quantified the effect of the complex intervention on the primary outcome using a negative binomial, mixed model adjusting for site, December/January months, site location, and background time trends in recruitment rate. We recruited and randomised 72 sites and recorded their monthly recruitment to RESTART over 24 months (March 2015 to February 2017 inclusive), providing 1728 site-months of observations for the primary analysis. The adjusted rate ratio for the number of patients randomised per month after allocation to the PRIME complex intervention versus control time before allocation to the PRIME complex intervention was 1.06 (95% confidence interval 0.55 to 2.03, p = 0.87). Although two thirds of respondents to the 6-month follow-up questionnaire agreed that the audit reports were useful, only six patients were reported to

Early home-supported discharge for patients with stroke in Portugal

DEFF Research Database (Denmark)

Santana, Silvina; Rente, José; Neves, Conceição

2017-01-01

Measure at six months after stroke. Results: We randomised 190 patients of whom 34 were lost to follow-up. There were no significant differences (p > 0.5) in the average scores of Functional Independence Measure between the early home-supported discharge (69 ±22; mean ±SD) and the control groups (71 ±17...

Social support and employment status modify the effect of intimate partner violence on depression symptom severity in women: results from the 2006 Behavioral Risk Factor Surveillance System Survey.

Science.gov (United States)

Dougé, Nathalie; Lehman, Erik B; McCall-Hosenfeld, Jennifer S

2014-01-01

Depression and intimate partner violence (IPV) are significant health issues for U.S. women. Interaction effects between IPV and other psychosocial factors on the severity of depressive symptoms have not been fully explored. This study assessed effect modification, that is, how IPV interacts with sociodemographics, psychosocial factors and health risk behaviors, on the severity of depressive symptoms in women. We utilized cross-sectional data from female respondents (n = 16,106) of the 2006 Behavioral Risk Factors Surveillance Survey. Sociodemographics, psychosocial variables, and health risk behaviors determined to be significantly associated with depression were tested for interaction effects with IPV. Weighted ordinal logistic regression and predicted probabilities illustrated the effect of IPV status on depressive symptom severity, stratified by interaction effects. Recent and lifetime IPV exposure were associated with more severe depressive symptoms compared with no IPV exposure. IPV history interacted with employment status and social support on the severity of depressive symptoms in women. Overall, any IPV exposure was associated with more severe depressive symptoms among women with low social support and unemployment, although the effect of recent (versus lifetime) IPV was most pronounced among women with high social support or employed women. Social support and employment status interact with IPV on the severity of depressive symptoms in women. Therefore, social support or workplace interventions designed to improve depressive symptoms should examine IPV history. Copyright © 2014 Jacobs Institute of Women's Health. Published by Elsevier Inc. All rights reserved.

Psychosocial employment characteristics and postpartum maternal mental health symptoms.

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Schwab-Reese, Laura M; Ramirez, Marizen; Ashida, Sato; Peek-Asa, Corinne

2017-01-01

For new mothers returning to work, the role of the workplace psychosocial environment on maternal mental health has not been fully described. The purpose of this study was to identify the relationship between psychosocial employment characteristics and mothers' postpartum depression, anxiety, and stress symptoms. Ninety-seven women answered survey questions regarding employment, job demand, control, and support, and postpartum depression, anxiety, and stress symptoms soon after live birth and 6 months later. Working and nonworking mothers reported similar mental health symptoms. Psychological characteristics of employment were not associated with increased odds of mental health symptoms. Increased social support provided by coworkers, supervisors, and the organization was associated with reduced odds of anxiety symptoms. Our findings identified lack of workplace social support as a modifiable risk factor for postpartum anxiety. Future evaluations of workplace social support interventions may be explored to improve postpartum mental health symptoms. Am. J. Ind. Med. 60:109-120, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

The London Exercise And Pregnant smokers (LEAP) trial: a randomised controlled trial of physical activity for smoking cessation in pregnancy with an economic evaluation.

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Ussher, Michael; Lewis, Sarah; Aveyard, Paul; Manyonda, Isaac; West, Robert; Lewis, Beth; Marcus, Bess; Riaz, Muhammad; Taylor, Adrian H; Barton, Pelham; Daley, Amanda; Essex, Holly; Esliger, Dale; Coleman, Tim

2015-10-01

Smoking during pregnancy is the main preventable cause of poor birth outcomes. Improved methods are needed to help women to stop smoking during pregnancy. Pregnancy provides a compelling rationale for physical activity (PA) interventions as cessation medication is contraindicated or ineffective, and an effective PA intervention could be highly cost-effective. To examine the effectiveness and cost-effectiveness of a PA intervention plus standard behavioural support for smoking cessation relative to behavioural support alone for achieving smoking cessation at the end of pregnancy. Multicentre, two-group, pragmatic randomised controlled trial and economic evaluation with follow-up at the end of pregnancy and 6 months postnatally. Randomisation was stratified by centre and a computer-generated sequence was used to allocate participants using a 1 : 1 ratio. 13 hospitals offering antenatal care in the UK. Women between 10 and 24 weeks' gestation smoking five or more cigarettes a day before pregnancy and one or more during pregnancy. Participants were randomised to behavioural support for smoking cessation (control) or behavioural support plus a PA intervention consisting of supervised treadmill exercise plus PA consultations. Neither participants nor researchers were blinded to treatment allocation. The primary outcome was self-reported, continuous smoking abstinence between a quit date and end of pregnancy, validated by expired carbon monoxide and/or salivary cotinine. Secondary outcomes were maternal weight, depression, birth outcomes, withdrawal symptoms and urges to smoke. The economic evaluation investigated the costs of the PA intervention compared with the control intervention. In total, 789 women were randomised (n = 394 PA, n = 395 control). Four were excluded post randomisation (two had been enrolled twice in sequential pregnancies and two were ineligible and randomised erroneously). The intention-to-treat analysis comprised 785 participants (n�

Achieving and sustaining full employment.

Science.gov (United States)

Rosen, S M

1995-01-01

Human rights and public health considerations provide strong support for policies that maximize employment. Ample historical and conceptual evidence supports the feasibility of full employment policies. New factors affecting the labor force, the rate of technological change, and the globalization of economic activity require appropriate policies--international as well as national--but do not invalidate the ability of modern states to apply the measures needed. Among these the most important include: (I) systematic reduction in working time with no loss of income, (2) active labor market policies, (3) use of fiscal and monetary measures to sustain the needed level of aggregate demand, (4) restoration of equal bargaining power between labor and capital, (5) social investment in neglected and outmoded infrastructure, (6) accountability of corporations for decisions to shift or reduce capital investment, (7) major reductions in military spending, to be replaced by socially needed and economically productive expenditures, (8) direct public sector job creation, (9) reform of monetary policy to restore emphasis on minimizing unemployment and promoting full employment. None are without precedent in modern economies. The obstacles are ideological and political. To overcome them will require intellectual clarity and effective advocacy.

Translation of randomised controlled trial findings into clinical practice: comparison of olanzapine and valproate in the EMBLEM study

DEFF Research Database (Denmark)

Novick, D; Gonzalez-Pinto, A; Haro, J M

2009-01-01

OBJECTIVES: The aim of this study was to compare the outcomes of olanzapine- and valproate-treated patients in an observational study of acute mania with the results of a randomised controlled trial (RCT) assessing the same treatments. METHODS: EMBLEM (European Mania in Bipolar Evaluation......: The EMBLEM results support those of the RCT, which suggest that olanzapine monotherapy seems to be more effective than valproate monotherapy in the treatment of acute mania....

Trends in Employer-Funded Training as an Indicator of Changes in Employment: The Case of Norway in the 1980s.

Science.gov (United States)

Gooderham, Paul N.; Hines, Kjell

1995-01-01

Norwegian data on employer-sponsored training revealed no public-sector support of the neo-Marxist theory of skill degrading; private-sector support for upgrading lower-level jobs and the emergence of flexible organizations; and limited support for bipolarization--increasing skills gap between full- and part-time workers. Bipolarization affected a…

Recruiting faith- and non-faith-based schools, adolescents and parents to a cluster randomised sexual-health trial: experiences, challenges and lessons from the mixed-methods Jack Feasibility Trial.

Science.gov (United States)

Aventin, Áine; Lohan, Maria; Maguire, Lisa; Clarke, Mike

2016-07-29

The move toward evidence-based education has led to increasing numbers of randomised trials in schools. However, the literature on recruitment to non-clinical trials is relatively underdeveloped, when compared to that of clinical trials. Recruitment to school-based randomised trials is, however, challenging, even more so when the focus of the study is a sensitive issue such as sexual health. This article reflects on the challenges of recruiting post-primary schools, adolescent pupils and parents to a cluster randomised feasibility trial of a sexual-health intervention, and the strategies employed to address them. The Jack Trial was funded by the UK National Institute for Health Research. It comprised a feasibility study of an interactive film-based sexual-health intervention entitled If I Were Jack, recruiting over 800 adolescents from eight socio-demographically diverse post-primary schools in Northern Ireland. It aimed to determine the facilitators and barriers to recruitment and retention to a school-based sexual-health trial and identify optimal multi-level strategies for an effectiveness study. As part of an embedded process evaluation, we conducted semi-structured interviews and focus groups with principals, vice-principals, teachers, pupils and parents recruited to the study as well as classroom observations and a parents' survey. With reference to social learning theory, we identified a number of individual-, behavioural- and environmental-level factors that influenced recruitment. Commonly identified facilitators included perceptions of the relevance and potential benefit of the intervention to adolescents, the credibility of the organisation and individuals running the study, support offered by trial staff, and financial incentives. Key barriers were prior commitment to other research, lack of time and resources, and perceptions that the intervention was incompatible with pupil or parent needs or the school ethos. Reflecting on the methodological

Effectiveness and cost-effectiveness of fining non-attendance at public hospitals: a randomised controlled trial from Danish outpatient clinics.

Science.gov (United States)

Blæhr, Emely Ek; Væggemose, Ulla; Søgaard, Rikke

2018-04-13

Fines have been proposed as means for reducing non-attendance in healthcare. The empirical evidence of the effect of fines is however limited. The objective of this study is to investigate the effectiveness and cost-effectiveness of fining non-attendance at outpatient clinics. 1:1 randomised controlled trial of appointments for an outpatient clinic, posted to Danish addresses, between 1 May 2015 and 30 November 2015. Only first appointment for users was included. Healthcare professionals and investigators were masked. A fine of DKK250 (€34) was issued for non-attendance. Users were informed about the fine in case of non-attendance by the appointment letter, and were able to reschedule or cancel until the appointment. A central administration office administered the fine system. The main outcome measures were non-attendance of non-cancelled appointments, fine policy administration costs, net of productivity consequences and probability of fining non-attendance being cost-effective over no fining for a range of hypothetical values of reduced non-attendance. All of the 6746 appointments included were analysed. Of the 3333 appointments randomised to the fine policy, 130 (5%) of non-cancelled appointments were unattended, and of the 3413 appointments randomised to no-fine policy, 131 (5%) were unattended. The cost per appointment of non-attendance was estimated at DKK 56 (SE 5) in the fine group and DKK47 (SE 4) in the no-fine group, leading to a non-statistically significant difference of DKK10 (95% CI -9 to 22) per appointment attributable to the fine policy. The probability of cost-effectiveness remained around 50%, irrespective of increased values of reduced non-attendance or various alternative assumptions used for sensitivity analyses. At a baseline level of around 5%, fining non-attendance does not seem to further reduce non-attendance. Future studies should focus on other means for reduction of non-attendance such as nudging or negative reinforcement. ISRCTN

The relative contribution of neurocognition and social cognition to 6-month vocational outcomes following Individual Placement and Support in first-episode psychosis.

Science.gov (United States)

Allott, Kelly A; Cotton, Susan M; Chinnery, Gina L; Baksheev, Gennady N; Massey, Jessica; Sun, Pamela; Collins, Zoe; Barlow, Emma; Broussard, Christina; Wahid, Tasha; Proffitt, Tina-Marie; Jackson, Henry J; Killackey, Eoin

2013-10-01

To examine whether baseline neurocognition and social cognition predict vocational outcomes over 6 months in patients with first-episode psychosis (FEP) enrolled in a randomised controlled trial of Individual Placement and Support (IPS) versus treatment as usual (TAU). 135 FEP participants (IPS n=69; TAU n=66) completed a comprehensive neurocognitive and social cognitive battery. Principal axis factor analysis using PROMAX rotation was used to determine the underlying cognitive structure of the battery. Setwise (hierarchical) logistic and multivariate linear regressions were used to examine predictors of: (a) enrolment in education and employment; and (b) hours of employment over 6 months. Neurocognition and social cognition factors were entered into the models after accounting for premorbid IQ, baseline functioning and treatment group. Six cognitive factors were extracted: (i) social cognition; (ii) information processing speed; (iii) verbal learning and memory; (iv) attention and working memory; (v) visual organisation and memory; and (vi) verbal comprehension. Enrolment in education over 6 months was predicted by enrolment in education at baseline (p=.002) and poorer visual organisation and memory (p=.024). Employment over 6 months was predicted by employment at baseline (p=.041) and receiving IPS (p=.020). Better visual organisation and memory predicted total hours of paid work over 6 months (paccounting for premorbid IQ, baseline functioning and treatment. Social cognition did not contribute to the prediction of vocational outcomes. Neurocognitive interventions may enhance employment duration in FEP. © 2013 Elsevier B.V. All rights reserved.

Good job, bad job: The employment experiences of women in recovery from substance abuse.

Science.gov (United States)

Sinakhone, Joyce K; Hunter, Bronwyn A; Jason, Leonard A

2017-01-01

Women in metropolitan areas have lower employment participation and employment rates than men. Although women face multiple challenges in the labor market, those who have a history of substance use and are abstinent may have a greater disadvantage in obtaining viable employment opportunities due to factors associated with substance use. No research to date has examined employment experiences among women in recovery from substance use. This study examined employment characteristics and experiences of women who had a history of substance use and lived in sober-living environments in urban areas. Data were collected through telephone interviews to sober living homes that were located in 20 urban areas. Themes identified through thematic analysis included employment challenges, the importance of work to substance abuse recovery, job satisfaction, employment aspirations, and employment support in the sober living home. Employment is important to women in substance abuse recovery, not only as a means for financial support, but also as a life priority. The results highlight how employer scheduling practices, low-level positions, and lack of employment supports impact recovery. Findings provide insight into the need for employment support services, including employer education and flexible policies for women in recovery.

Interdisciplinary model of care (RADICALS) for early detection and management of chronic obstructive pulmonary disease (COPD) in Australian primary care: study protocol for a cluster randomised controlled trial.

Science.gov (United States)

Liang, Jenifer; Abramson, Michael J; Zwar, Nicholas; Russell, Grant; Holland, Anne E; Bonevski, Billie; Mahal, Ajay; Hecke, Benjamin van; Phillips, Kirsten; Eustace, Paula; Paul, Eldho; Petrie, Kate; Wilson, Sally; George, Johnson

2017-09-18

Up to half of all smokers develop clinically significant chronic obstructive pulmonary disease (COPD). Gaps exist in the implementation and uptake of evidence-based guidelines for managing COPD in primary care. We describe the methodology of a cluster randomised controlled trial (cRCT) evaluating the efficacy and cost-effectiveness of an interdisciplinary model of care aimed at reducing the burden of smoking and COPD in Australian primary care settings. A cRCT is being undertaken to evaluate an interdisciplinary model of care (RADICALS - Review of Airway Dysfunction and Interdisciplinary Community-based care of Adult Long-term Smokers). General practice clinics across Melbourne, Australia, are identified and randomised to the intervention group (RADICALS) or usual care. Patients who are current or ex-smokers, of at least 10 pack years, including those with an existing diagnosis of COPD, are being recruited to identify 280 participants with a spirometry-confirmed diagnosis of COPD. Handheld lung function devices are being used to facilitate case-finding. RADICALS includes individualised smoking cessation support, home-based pulmonary rehabilitation and home medicines review. Patients at control group sites receive usual care and Quitline referral, as appropriate. Follow-ups occur at 6 and 12 months from baseline to assess changes in quality of life, abstinence rates, health resource utilisation, symptom severity and lung function. The primary outcome is change in St George's Respiratory Questionnaire score of patients with COPD at 6 months from baseline. This project has been approved by the Monash University Human Research Ethics Committee and La Trobe University Human Ethics Committee (CF14/1018 - 2014000433). Results of the study will be disseminated in peer-reviewed journals and research conferences. If the intervention is successful, the RADICALS programme could potentially be integrated into general practices across Australia and sustained over time. ACTRN

Pathways: patient-centred decision counselling for women at risk of cancer-related infertility: a protocol for a comparative effectiveness cluster randomised trial.

Science.gov (United States)

Woodard, Terri Lynn; Hoffman, Aubri S; Crocker, Laura C; Holman, Deborah A; Hoffman, Derek B; Ma, Jusheng; Bassett, Roland L; Leal, Viola B; Volk, Robert J

2018-02-21

National guidelines recommend that all reproductive-age women with cancer be informed of their fertility risks and offered referral to fertility specialists to discuss fertility preservation options. However, reports indicate that only 5% of patients have consultations, and rates of long-term infertility-related distress remain high. Previous studies report several barriers to fertility preservation; however, initial success has been reported using provider education, patient decision aids and navigation support. This protocol will test effects of a multicomponent intervention compared with usual care on women's fertility preservation knowledge and decision-making outcomes. This cluster-randomised trial will compare the multicomponent intervention (provider education, patient decision aid and navigation support) with usual care (consultation and referral, if requested). One hundred newly diagnosed English-speaking women of reproductive age who are at risk of cancer-related infertility will be recruited from four regional oncology clinics.The Pathways patient decision aid website provides (1) up-to-date evidence and descriptions of fertility preservation and other family-building options, tailored to cancer type; (2) structured guidance to support personalising the information and informed decision-making; and (3) a printable summary to help women prepare for discussions with their oncologist and/or fertility specialist. Four sites will be randomly assigned to intervention or control groups. Participants will be recruited after their oncology consultation and asked to complete online questionnaires at baseline, 1 week and 2 months to assess their demographics, fertility preservation knowledge, and decision-making process and quality. The primary outcome (decisional conflict) will be tested using Fisher's exact test. Secondary outcomes will be assessed using generalised linear mixed models, and sensitivity analyses will be conducted, as appropriate. The University of

Financial disincentives? A three-armed randomised controlled trial of the effect of financial Incentives  in Diabetic Eye Assessment  by Screening (IDEAS) trial.

Science.gov (United States)

Judah, Gaby; Darzi, Ara; Vlaev, Ivo; Gunn, Laura; King, Derek; King, Dominic; Valabhji, Jonathan; Bicknell, Colin

2018-05-23

Conflicting evidence exists regarding the impact of financial incentives on encouraging attendance at medical screening appointments. The primary aim was to determine whether financial incentives increase attendance at diabetic eye screening in persistent non-attenders. A three-armed randomised controlled trial was conducted in London in 2015. 1051 participants aged over 16 years, who had not attended eye screening appointments for 2 years or more, were randomised (1.4:1:1 randomisation ratio) to receive the usual invitation letter (control), an offer of £10 cash for attending screening (fixed incentive) or a 1 in 100 chance of winning £1000 (lottery incentive) if they attend. The primary outcome was the proportion of invitees attending screening, and a comparative analysis was performed to assess group differences. Pairwise comparisons of attendance rates were performed, using a conservative Bonferroni correction for independent comparisons. 34/435 (7.8%) of control, 17/312 (5.5%) of fixed incentive and 10/304 (3.3%) of lottery incentive groups attended. Participants who received any incentive were significantly less likely to attend their appointment compared with controls (risk ratio (RR)=0.56; 95% CI 0.34 to 0.92). Those in the probabilistic incentive group (RR=0.42; 95% CI 0.18 to 0.98), but not the fixed incentive group (RR=1.66; 95% CI 0.65 to 4.21), were significantly less likely to attend than those in the control group. Financial incentives, particularly lottery-based incentives, attract fewer patients to diabetic eye screening than standard invites in this population. Financial incentives should not be used to promote screening unless tested in context, as they may negatively affect attendance rates. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Psychosocial therapy for Parkinson's-related dementia: study protocol for the INVEST randomised controlled trial.

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McCormick, Sheree A; McDonald, Kathryn R; Vatter, Sabina; Orgeta, Vasiliki; Poliakoff, Ellen; Smith, Sarah; Silverdale, Monty A; Fu, Bo; Leroi, Iracema

2017-06-19

Parkinson's disease (PD) with mild cognitive impairment (MCI-PD) or dementia (PDD) and dementia with Lewy bodies (DLB) are characterised by motor and 'non-motor' symptoms which impact on quality of life. Treatment options are generally limited to pharmacological approaches. We developed a psychosocial intervention to improve cognition, quality of life and companion burden for people with MCI-PD, PDD or DLB. Here, we describe the protocol for a single-blind randomised controlled trial to assess feasibility, acceptability and tolerability of the intervention and to evaluate treatment implementation. The interaction among the intervention and selected outcome measures and the efficacy of this intervention in improving cognition for people with MCI-PD, PDD or DLB will also be explored. Dyads will be randomised into two treatment arms to receive either 'treatment as usual' (TAU) or cognitive stimulation therapy specifically adapted for Parkinson's-related dementias (CST-PD), involving 30 min sessions delivered at home by the study companion three times per week over 10 weeks. A mixed-methods approach will be used to collect data on the operational aspects of the trial and treatment implementation. This will involve diary keeping, telephone follow-ups, dyad checklists and researcher ratings. Analysis will include descriptive statistics summarising recruitment, acceptability and tolerance of the intervention, and treatment implementation. To pilot an outcome measure of efficacy, we will undertake an inferential analysis to test our hypothesis that compared with TAU, CST-PD improves cognition. Qualitative approaches using thematic analysis will also be applied. Our findings will inform a larger definitive trial. Ethical opinion was granted (REC reference: 15/YH/0531). Findings will be published in peer-reviewed journals and at conferences. We will prepare reports for dissemination by organisations involved with PD and dementia. ISRCTN (ISRCTN11455062). © Article author

Benefits of home-based multidisciplinary exercise and supportive care in inoperable non-small cell lung cancer - protocol for a phase II randomised controlled trial.

Science.gov (United States)

Edbrooke, Lara; Aranda, Sanchia; Granger, Catherine L; McDonald, Christine F; Krishnasamy, Mei; Mileshkin, Linda; Irving, Louis; Braat, Sabine; Clark, Ross A; Gordon, Ian; Denehy, Linda

2017-09-29

Lung cancer is one of the most commonly diagnosed cancers, and is a leading cause of cancer mortality world-wide. Due to lack of early specific symptoms, the majority of patients present with advanced, inoperable disease and five-year relative survival across all stages of non-small cell lung cancer (NSCLC) is 14%. People with lung cancer also report higher levels of symptom distress than those with other forms of cancer. Several benefits for survival and patient reported outcomes are reported from physical activity and exercise in other tumour groups. We report the protocol for a study investigating the benefits of exercise, behaviour change and symptom self-management for patients with recently diagnosed, inoperable, NSCLC. This multi-site, parallel-group, assessor-blinded randomised controlled trial, powered for superiority, aims to assess functional and patient-reported outcomes of a multi-disciplinary, home-based exercise and supportive care program for people commencing treatment. Ninety-two participants are being recruited from three tertiary-care hospitals in Melbourne, Australia. Following baseline testing, participants are randomised using concealed allocation, to receive either: a) 8 weeks of home-based exercise (comprising an individualised endurance and resistance exercise program and behaviour change coaching) and nurse-delivered symptom self-management intervention or b) usual care. The primary outcome is the between-group difference in the change in functional exercise capacity (six-minute walk distance) from baseline to post-program assessment. Secondary outcomes include: objective and self-reported physical activity levels, physical activity self-efficacy, behavioural regulation of motivation to exercise and resilience, muscle strength (quadriceps and grip), health-related quality of life, anxiety and depression and symptom interference. There is a lack of evidence regarding the benefit of exercise intervention for people with NSCLC, particularly

Internet-delivered cognitive behavioural therapy for children with anxiety disorders: A randomised controlled trial.

Science.gov (United States)

Vigerland, Sarah; Ljótsson, Brjánn; Thulin, Ulrika; Öst, Lars-Göran; Andersson, Gerhard; Serlachius, Eva

2016-01-01

Cognitive behaviour therapy (CBT) has been shown to be an effective treatment for anxiety disorders in children, but few affected seek or receive treatment. Internet-delivered CBT (ICBT) could be a way to increase the availability of empirically supported treatments. A randomised controlled trial was conducted to evaluate ICBT for children with anxiety disorders. Families (N = 93) with a child aged 8-12 years with a principal diagnosis of generalised anxiety disorder, panic disorder, separation anxiety, social phobia or specific phobia were recruited through media advertisement. Participants were randomised to 10 weeks of ICBT with therapist support, or to a waitlist control condition. The primary outcome measure was the Clinician Severity Rating (CSR) and secondary measures included child- and parent-reported anxiety. Assessments were made at pre-treatment, post-treatment and at three-month follow-up. At post-treatment, there were significant reductions on CSR in the treatment group, with a large between-group effect size (Cohen's d = 1.66). Twenty per cent of children in the treatment group no longer met criteria for their principal diagnosis at post-treatment and at follow-up this number had increased to 50%. Parent-reported child anxiety was significantly lower in the treatment group than in the waitlist group at post-treatment, with a small between-group effect size (Cohen's d = 0.45). There were no significant differences between the groups regarding child-ratings of anxiety at post-treatment. Improvements were maintained at three-month follow-up, although this should be interpreted cautiously due to missing data. Within the limitations of this study, results suggest that ICBT with therapist support for children with anxiety disorders can reduce clinician- and parent-rated anxiety symptoms. Clinicaltrials.gov: NCT01533402. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Employment and educational outcomes in early intervention programmes for early psychosis: a systematic review.

Science.gov (United States)

Bond, G R; Drake, R E; Luciano, A

2015-10-01

Young adults with early psychosis want to pursue normal roles - education and employment. This paper summarises the empirical literature on the effectiveness of early intervention programmes for employment and education outcomes. We conducted a systematic review of employment/education outcomes for early intervention programmes, distinguishing three programme types: (1) those providing supported employment, (2) those providing unspecified vocational services and (3) those without vocational services. We summarised findings for 28 studies. Eleven studies evaluated early intervention programmes providing supported employment. In eight studies that reported employment outcomes separately from education outcomes, the employment rate during follow-up for supported employment patients was 49%, compared with 29% for patients receiving usual services. The two groups did not differ on enrolment in education. In four controlled studies, meta-analysis showed that the employment rate for supported employment participants was significantly higher than for control participants, odds ratio = 3.66 [1.93-6.93], p < 0.0001. Five studies (four descriptive and one quasi-experimental) of early intervention programmes evaluating unspecified vocational services were inconclusive. Twelve studies of early intervention programmes without vocational services were methodologically heterogeneous, using diverse methods for evaluating vocational/educational outcomes and precluding a satisfactory meta-analytic synthesis. Among studies with comparison groups, 7 of 11 (64%) reported significant vocational/education outcomes favouring early intervention over usual services. In early intervention programmes, supported employment moderately increases employment rates but not rates of enrolment in education. These improvements are in addition to the modest effects early programmes alone have on vocational/educational outcomes compared with usual services.

Effects of advanced life support versus basic life support on the mortality rates of patients with trauma in prehospital settings: a study protocol for a systematic review and meta-analysis.

Science.gov (United States)

Kondo, Yutaka; Fukuda, Tatsuma; Uchimido, Ryo; Hifumi, Toru; Hayashida, Kei

2017-10-22

Advanced life support (ALS) is thought to be associated with improved survival in prehospital trauma care when compared with basic life support (BLS). However, evidence on the benefits of prehospital ALS for patients with trauma is controversial. Therefore, we aim to clarify if ALS improves mortality in patients with trauma when compared with BLS by conducting a systematic review and meta-analysis of the recent literature. We will perform searches in PubMed, Embase and the Cochrane Central Register of Controlled Trials for published observational studies, controlled before-and-after studies, randomised controlled trials and other controlled trials conducted in humans and published until March 2017. We will screen search results, assess study selection, extract data and assess the risk of bias in duplicate; disagreements will be resolved through discussions. Data from clinically homogeneous studies will be pooled using a random-effects meta-analysis, heterogeneity of effects will be assessed using the χ 2 test of homogeneity, and any observed heterogeneity will be quantified using the I 2 statistic. Last, the Grading of Recommendations Assessment, Development and Evaluation approach will be used to rate the quality of the evidence. Our study does not require ethical approval as it is based on findings of previously published articles. Results will be disseminated through publication in a peer-reviewed journal, presentations at relevant conferences and publications for patient information. PROSPERO (International Prospective Register of Systematic Reviews) registration number CRD42017054389. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Implementing a complex intervention to support personal recovery: a qualitative study nested within a cluster randomised controlled trial.

Directory of Open Access Journals (Sweden)

Mary Leamy

Full Text Available OBJECTIVE: To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams. DESIGN: Process evaluation nested within a cluster randomised controlled trial (RCT. PARTICIPANTS: 28 interviews with mental health care staff, 3 interviews with trainers, 4 focus groups with intervention teams and 28 written trainer reports. SETTING: 14 community-based mental health teams in two UK sites (one urban, one semi-rural who received the intervention. RESULTS: The factors influencing the implementation of the intervention can be organised under two over-arching themes: Organisational readiness for change and Training effectiveness. Organisational readiness for change comprised three sub-themes: NHS Trust readiness; Team readiness; and Practitioner readiness. Training effectiveness comprised three sub-themes: Engagement strategies; Delivery style and Modelling recovery principles. CONCLUSIONS: Three findings can inform future implementation and evaluation of complex interventions. First, the underlying intervention model predicted that three areas would be important for changing practice: staff skill development; intention to implement; and actual implementation behaviour. This study highlighted the importance of targeting the transition from practitioners' intent to implement to actual implementation behaviour, using experiential learning and target setting. Second, practitioners make inferences about organisational commitment by observing the allocation of resources, Knowledge Performance Indicators and service evaluation outcome measures. These need to be aligned with recovery values, principles and practice. Finally, we recommend the use of organisational readiness tools as an inclusion criteria for selecting both organisations and teams in cluster RCTs. We believe this would

Leveraging Employer Practices in Global Regulatory Frameworks to Improve Employment Outcomes for People with Disabilities

Directory of Open Access Journals (Sweden)

Matthew C. Saleh

2018-03-01

Full Text Available Work is an important part of life, providing both economic security and a forum to contribute one’s talents and skills to society, thereby anchoring the individual in a social role. However, access to work is not equally available to people with disabilities globally. Regulatory environments that prohibit discrimination and support vocational training and educational opportunities constitute a critical first step toward economic independence. However, they have not proven sufficient in themselves. In this article, we aim to infuse deeper consideration of employer practice and demand-side policy reforms into global policy discussions of the right to work for people with disabilities. We begin by documenting the employment and economic disparities existing for people with disabilities globally, followed by a description of the international, regional, and local regulatory contexts aiming to improve labor market outcomes for people with disabilities. Next, we examine how policies can leverage employer interests to further address inequalities. We discuss employer policies and practices demonstrated in the research to facilitate recruitment, hiring, career development, retention, and meaningful workplace inclusion. The goal of the article is to synthesize existing international literature on employment rights for people with disabilities with the employer perspective.

Empowering students by enhancing their\\ud employability skills

OpenAIRE

Scott, Fraser J.; Connell, Pauline; Thomson, Linda A.; Willison, Debra

2017-01-01

Recognising the importance of graduates being equipped with appropriate employability skills alongside their subject-specific skills, we have had transferable skills training embedded throughout our degree programmes for 30 years. More recently, a specific employability skills module for final-year honours students has been created. This module consists of a programme of\\ud activities supporting employability skills, which was delivered to final-year undergraduate students from 2012 to 2015. ...

Effects of the implementation of the web-based patient support system on staff's attitudes towards computers and IT use: a randomised controlled trial.

Science.gov (United States)

Koivunen, Marita; Välimäki, Maritta; Patel, Anita; Knapp, Martin; Hätönen, Heli; Kuosmanen, Lauri; Pitkänen, Anneli; Anttila, Minna; Katajisto, Jouko

2010-09-01

Utilisation of information technology (IT) in the treatment of people with severe mental health problems is an unknown area in Europe. Use of IT and guiding patients to relevant sources of health information requires that nursing staff have positive attitudes toward computers and accept IT use as a part of daily practises. The aim of the study was to assess the effects of the implementation of a web-based patient support system on staff's attitudes towards computers and IT use on psychiatric wards. Hundred and forty-nine nurses in two psychiatric hospitals in Finland were randomised to two groups to deliver patient education for patients with schizophrenia and psychosis with a web-based system (n = 76) or leaflets (n = 73). After baseline nurses were followed-up for 18 months after the introduction of the system. The primary outcome was nurses' motivation to utilise computers, and the secondary outcomes were nurses' beliefs in and satisfaction with computers, and use of computer and internet. There were no statistically significant differences between study groups in attitudes towards computers (motivation p = 0.936, beliefs p = 0.270, satisfaction p = 0.462) and internet use (p = 0.276). However, nurses' general computer use (p = 0.029) increased more in the leaflet group than in the IT intervention group. We can conclude that IT has promise as an alternative method in patient education, as the implementation of the web-based patient support system in daily basis did not have a negative effect on nurses' attitudes towards IT. © 2010 The Authors. Journal compilation © 2010 Nordic College of Caring Science.

International Experience, Universities Support and Graduate Employability--Perceptions of Chinese International Students Studying in UK Universities

Science.gov (United States)

Huang, Rong; Turner, Rebecca

2018-01-01

Recent policy developments in English Higher Education have resulted in employability placed in the spotlight, whereby the success of universities will be measured based on graduate employment. This represents the latest focus placed on employability in the sector, as universities are increasingly expected to provide employment-ready graduates to…

Employee perception of breastfeeding-friendly support and benefits of breastfeeding as a predictor of intention to use breast-pumping breaks after returning to work among employed mothers.

Science.gov (United States)

Tsai, Su-Ying

2014-01-01

Although increasing numbers of large companies are complying with demands for a breastfeeding-friendly workplace by providing lactation rooms and breast-pumping breaks, the effectiveness for intention to use breast-pumping breaks to express breast milk among employed mothers is uncertain. To explore the impact of employees' perceived breastfeeding support from the workplace and the benefits of breastfeeding on a woman's intention to use breast-pumping breaks after returning to work, we conducted a survey at a female labor-intensive electronics manufacturer in Taiwan. A structured questionnaire survey was administered to 715 working mothers employed in an electronics manufacturing plant in Tainan Science Park in Southern Taiwan. Questionnaire content included female employee demographics, employment characteristics, and breastfeeding behavior after returning to work, as well as employees' perception of breastfeeding-friendly support and awareness of the benefits of breastfeeding when raising their most recently born child. Higher education (odds ratio [OR] 2.33), non-clean room worksite (OR 1.51), awareness of breast-pumping breaks (OR 4.70), encouragement by colleagues to use breast-pumping breaks (OR 1.76), and greater awareness of the benefits of breastfeeding (OR 1.08) were significant predictors of the use of breast-pumping breaks after returning to work, whereas the perception of inefficiency when using breast-pumping breaks reduced an employed mother's intention to use breast-pumping breaks (OR 0.55). This study finds an association between an appreciation of the benefits provided by the employer and the likelihood of increased usage of breastfeeding breaks. Workplaces and employers can help employed mothers to understand the benefits of breastfeeding, which may increase the intention of the mother to take breast-pumping breaks after returning to work.

Employee Perception of Breastfeeding-Friendly Support and Benefits of Breastfeeding as a Predictor of Intention to Use Breast-Pumping Breaks After Returning to Work Among Employed Mothers

Science.gov (United States)

2014-01-01

Abstract Background: Although increasing numbers of large companies are complying with demands for a breastfeeding-friendly workplace by providing lactation rooms and breast-pumping breaks, the effectiveness for intention to use breast-pumping breaks to express breast milk among employed mothers is uncertain. To explore the impact of employees' perceived breastfeeding support from the workplace and the benefits of breastfeeding on a woman's intention to use breast-pumping breaks after returning to work, we conducted a survey at a female labor-intensive electronics manufacturer in Taiwan. Subjects and Methods: A structured questionnaire survey was administered to 715 working mothers employed in an electronics manufacturing plant in Tainan Science Park in Southern Taiwan. Questionnaire content included female employee demographics, employment characteristics, and breastfeeding behavior after returning to work, as well as employees' perception of breastfeeding-friendly support and awareness of the benefits of breastfeeding when raising their most recently born child. Results: Higher education (odds ratio [OR] 2.33), non–clean room worksite (OR 1.51), awareness of breast-pumping breaks (OR 4.70), encouragement by colleagues to use breast-pumping breaks (OR 1.76), and greater awareness of the benefits of breastfeeding (OR 1.08) were significant predictors of the use of breast-pumping breaks after returning to work, whereas the perception of inefficiency when using breast-pumping breaks reduced an employed mother's intention to use breast-pumping breaks (OR 0.55). Conclusions: This study finds an association between an appreciation of the benefits provided by the employer and the likelihood of increased usage of breastfeeding breaks. Workplaces and employers can help employed mothers to understand the benefits of breastfeeding, which may increase the intention of the mother to take breast-pumping breaks after returning to work. PMID:24304034

Choosing a control intervention for a randomised clinical trial

Directory of Open Access Journals (Sweden)

Djulbegovic Benjamin

2003-04-01

Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.

The Impact of Employer Branding on Employees: The Role of Employment Offering in the Prediction of Their Affective Commitment

Directory of Open Access Journals (Sweden)

Dorothée Hanin

2013-12-01

Full Text Available Most studies dedicated to the examination of employer branding in industrial/ organisational psychology investigated it using samples of applicants. The objective of the present research was to study the influence of the employer branding of a company on its employees’ attitudes. More precisely, we examined the interactive effect of the employment offering as portrayed by organisational communications and the employment experience as lived by employees on their affective commitment (AC. Furthermore, we analysed the mechanisms underlying these relationships, i.e. perceived organisational support (POS and psychological contract violation (PCV. One-hundred eighty-six department managers of a large multinational retailing company involved in employer branding practices were surveyed. Results indicated that employment offering and lived employment experience interact in the prediction of both POS and PCV and this interactive effect carries over to AC. Implications of these findings for both researchers and practitioners are discussed.

Randomised controlled trials: important but overrated?

LENUS (Irish Health Repository)

Boylan, J F

2012-02-01

Practising physicians individualise treatments, hoping to achieve optimal outcomes by tackling relevant patient variables. The randomised controlled trial (RCT) is universally accepted as the best means of comparison. Yet doctors sometimes wonder if particular patients might benefit more from treatments that fared worse in the RCT comparisons. Such clinicians may even feel ostracised by their peers for stepping outside treatments based on RCTs and guidelines. Are RCTs the only acceptable evaluations of how patient care can be assessed and delivered? In this controversy we explore the interpretation of RCT data for practising clinicians facing individualised patient choices. First, critical care anaesthetists John Boylan and Brian Kavanagh emphasise the dangers of bias and show how Bayesian approaches utilise prior probabilities to improve posterior (combined) probability estimates. Secondly, Jane Armitage, of the Clinical Trial Service Unit in Oxford, argues why RCTs remain essential and explores how the quality of randomisation can be improved through systematic reviews and by avoiding selective reporting.

Protocol for Compass: a randomised controlled trial of primary HPV testing versus cytology screening for cervical cancer in HPV-unvaccinated and vaccinated women aged 25-69 years living in Australia.

Science.gov (United States)

Canfell, Karen; Saville, Marion; Caruana, Michael; Gebski, Val; Darlington-Brown, Jessica; Brotherton, Julia; Heley, Stella; Castle, Philip E

2018-01-26

Australia's National Cervical Screening Program (NCSP) currently recommends 2-year cytology in women aged 18-69 years. Following a review of the NCSP prompted by the implementation of human papillomavirus (HPV) vaccination, the programme will transition in 2017 to 5-year primary HPV screening with partial genotyping for HPV16/18 in women aged 25-74 years. Compass is a sentinel experience for the renewed NCSP and the first prospectively randomised trial of primary HPV screening compared with cytology to be conducted in a population with high uptake of HPV vaccination. This protocol describes the main Compass trial, which commenced after a pilot study of ~5000 women completed recruitment. Women aged 25-69 years will be randomised at a 1:2 allocation to (1) 2.5-year image-read, liquid-based cytology (LBC) screening with HPV triage of low-grade smears (active control Arm A) or (2) 5-year HPV screening with partial genotyping and referral of HPV16/18-positive women to colposcopy (intervention Arm B). Women in Arm B positive for other oncogenic HPV (not 16/18) will undergo secondary randomisation at a 1:1 allocation to either LBC or dual-stained (p16 INK4a and Ki-67) cytology testing (dual-stained cytology). The primary outcome is cumulative CIN3+ (CIN3, adenocarcinoma in situ and invasive cervical cancer) following a 5-year HPV exit testing round in both arms, in women randomised to the HPV arm versus women randomised to the LBC arm, based on an intention-to-treat analysis. The primary outcome will first be tested for non-inferiority and if declared, the primary outcome will be tested for superiority. A total of 36 300 women in birth cohorts not offered vaccination and 84 700 women in cohorts offered vaccination will be recruited, bringing the final sample size to 121 000. The trial is powered for the secondary outcome of cumulative CIN3+ in screen-negative women, adjusted for censoring after CIN2+ treatment and hysterectomy. Approved by the Bellberry Ethics

Randomised studies of income supplementation: a lost opportunity to assess health outcomes.

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Connor, J; Rodgers, A; Priest, P

1999-11-01

Despite the wealth of evidence linking low income to ill health, there is little information from randomised studies on how much and how quickly these risks can be reversed by improvements in income. To conduct a systematic review of randomised studies of income supplementation, with particular reference to health outcomes. Extensive searches of electronic databases and contact with previous authors. As well as searching for trials that were specifically designed to assess the effects of increased income, studies of winners and losers of lotteries were also sought: if winning is purely chance, such studies are, in effect, randomised trials of increased income. Ten relevant studies were identified, all conducted in North America, mostly in the late 1960s and 1970s. Five trials were designed to assess the effects of income supplementation on workforce participation and randomised a total of 10,000 families to 3-5 years of various combinations of minimum income guarantees and reduced tax rates. Two trials were designed to assess re-offending rates in recently released prisoners and randomised a total of 2400 people to 3-6 months of benefits. One trial was designed to assess housing allowances and randomised 3500 families to three years of income supplements. One trial assessed the health effects of 12 months of income supplementation in 54 people with severe mental illness. Finally, one study compared three groups of people who won different amounts of money in a state lottery. In all these studies the interventions resulted in increases in income of at least one fifth. However, no reliable analyses of health outcome data are available. Extensive opportunities to reliably assess the effects of increases in income on health outcomes have been missed. Such evidence might have increased the consideration of potential health effects during deliberations about policies that have major implications for income, such as taxation rates, benefit policies, and minimum wage

Labor and Love: Wives' Employment and Divorce Risk in its Socio-Political Context

OpenAIRE

L. P. Cooke; J. Erola; M. Evertsson; M. Gahler; J. Harkonen; B. Hewitt; M. Jalovaara; M.-Y. Kan; T. H. Lyngstad; L. Mencarini; J.-F. Mignot; D. Mortelmans; A.-R. Poortman; C. Schmitt; H. Trappe

2013-01-01

We theorize how social policy affects marital stability vis-à-vis macro and micro effects of wives' employment on divorce risk in 11 Western countries. Correlations among 1990s aggregate data on marriage, divorce, and wives' employment rates, along with attitudinal and social policy information, seem to support specialization hypotheses that divorce rates are higher where more wives are employed and where policies support that employment. This is an ecological fallacy, however, because of the...

Meta Salud Diabetes study protocol: a cluster-randomised trial to reduce cardiovascular risk among a diabetic population of Mexico.

Science.gov (United States)

Sabo, Samantha; Denman Champion, Catalina; Bell, Melanie L; Cornejo Vucovich, Elsa; Ingram, Maia; Valenica, Celina; Castro Vasquez, Maria Del Carmen; Gonzalez-Fagoaga, Eduardo; Geurnsey de Zapien, Jill; Rosales, Cecilia B

2018-03-12

Northern Mexico has among the highest rates of cardiovascular disease (CVD) and diabetes in the world. This research addresses core gaps in implementation science to develop, test and scale-up CVD risk-reduction interventions in diabetics through a national primary care health system. The Meta Salud Diabetes (MSD) research project is a parallel two-arm cluster-randomised clinical behavioural trial based in 22 (n=22) health centres in Sonora, Mexico. MSD aims to evaluate the effectiveness of the MSD intervention for the secondary prevention of CVD risk factors among a diabetic population (n=320) compared with the study control of usual care. The MSD intervention consists of 2-hour class sessions delivered over a 13-week period providing educational information to encourage sustainable behavioural change to prevent disease complications including the adoption of physical activity. MSD is delivered within the context of Mexico's national primary care health centre system by health professionals, including nurses, physicians and community health workers via existing social support groups for individuals diagnosed with chronic disease. Mixed models are used to estimate the effect of MSD by comparing cardiovascular risk, as measured by the Framingham Risk Score, between the trial arms. Secondary outcomes include hypertension, behavioural risk factors and psychosocial factors. This work is supported by the National Institutes of Health, National Heart Lung and Blood Institute (1R01HL125996-01) and approved by the University of Arizona Research Institutional Review Board (Protocol 1508040144) and the Research Bioethics Committee at the University of Sonora. The first Internal Review Board approval date was 31 August 2015 with five subsequent approved amendments. This article refers to protocol V.0.2, dated 30 January 2017. Results will be disseminated via peer-reviewed publication and presentation at international conferences and will be shared through meetings with health

Systematic reviews of randomised clinical trials examining the effects of psychotherapeutic interventions versus "no intervention" for acute major depressive disorder and a randomised trial examining the effects of "third wave" cognitive therapy versus mentalization-based treatment for acute major

DEFF Research Database (Denmark)

Jakobsen, Janus Christian

2014-01-01

systematic reviews with meta-analyses and trial sequential analyses using The Cochrane Collaboration methodology examining the effects of cognitive therapy and psycho-dynamic therapy for major depressive disorder. We developed a thorough treatment protocol for a randomised trial with low risks of bias...... therapy versus mentalisation-based treatment for major depressive disorder. The first systematic review included five randomised trials examining the effects of psychodynamic therapy versus "no intervention' for major depressive disorder. Altogether the five trials randomised 365 participants who in each...... this result. The second systematic review included 12 randomised trials examining the effects of cognitive therapy versus "no intervention" for major depressive disorder. Altogether a total of 669 participants were randomised. All trials had high risk of bias. Meta-analysis showed that cognitive therapy...

The economic effects of supporting tuberculosis-affected households in Peru

Science.gov (United States)

Tovar, Marco A.; Huff, Doug; Boccia, Delia; Montoya, Rosario; Ramos, Eric; Lewis, James J.; Gilman, Robert H.; Evans, Carlton A.

2016-01-01

The End TB Strategy mandates that no tuberculosis (TB)-affected households face catastrophic costs due to TB. However, evidence is limited to evaluate socioeconomic support to achieve this change in policy and practice. The objective of the present study was to investigate the economic effects of a TB-specific socioeconomic intervention. The setting was 32 shantytown communities in Peru. The participants were from households of consecutive TB patients throughout TB treatment administered by the national TB programme. The intervention consisted of social support through household visits and community meetings, and economic support through cash transfers conditional upon TB screening in household contacts, adhering to TB treatment/chemoprophylaxis and engaging with social support. Data were collected to assess TB-affected household costs. Patient interviews were conducted at treatment initiation and then monthly for 6 months. From February 2014 to June 2015, 312 households were recruited, of which 135 were randomised to receive the intervention. Cash transfer total value averaged US$173 (3.5% of TB-affected households' average annual income) and mitigated 20% of households' TB-related costs. Households randomised to receive the intervention were less likely to incur catastrophic costs (30% (95% CI 22–38%) versus 42% (95% CI 34–51%)). The mitigation impact was higher among poorer households. The TB-specific socioeconomic intervention reduced catastrophic costs and was accessible to poorer households. Socioeconomic support and mitigating catastrophic costs are integral to the End TB strategy, and our findings inform implementation of these new policies. PMID:27660507

Supporting the role of community members employed as research staff: Perspectives of community researchers working in addiction research.

Science.gov (United States)

True, Gala; Alexander, Leslie B; Fisher, Celia B

2017-08-01

Community researchers are laypersons who conduct research activities in their own communities. In addiction and HIV research, community researchers are valued for their insider status and knowledge. At the same time, their presence on the research team raises concerns about coercion and confidentiality when community researchers and participants know each other personally, and the work of navigating between the worlds of research and community leads to moral distress and burnout for some community researchers. In this paper, we draw upon the concept of 'moral experience' to explore the local moral worlds of community researchers in the context of addiction research. In February and March 2010, we conducted focus groups with 36 community researchers employed on community-based addiction studies in the United States to elicit perspectives on ethical and moral challenges they face in their work and insights on best practices to support their role in research. Community researchers described how their values were realized or thwarted in the context of research, and their strategies for coping with shifting identities and competing priorities. They delineated how their knowledge could be used to inform development of research protocols and help principal investigators build and maintain trust with the community researchers on their teams. Our findings contribute to current understandings of the moral experiences of community members employed in research, and inform policies and practices for the growing field of community-engaged research. Funders, research organizations, and research ethics boards should develop guidelines and standards to ensure studies have key resources in place to support community researchers and ensure quality and integrity of community-engaged work. Investigators who work with community researchers should ensure channels for frontline staff to provide input on research protocols and to create an atmosphere where challenges and concerns can be

The efficacy of motivational counselling and SMS reminders on daily sitting time in patients with rheumatoid arthritis: a randomised controlled trial.

Science.gov (United States)

Thomsen, Tanja; Aadahl, Mette; Beyer, Nina; Hetland, Merete Lund; Løppenthin, Katrine; Midtgaard, Julie; Christensen, Robin; Østergaard, Mikkel; Jennum, Poul Jørgen; Esbensen, Bente Appel

2017-09-01

The aim of this report is to investigate the efficacy of an individually tailored, theory-based behavioural intervention for reducing daily sitting time, pain and fatigue, as well as improving health-related quality of life, general self-efficacy, physical function and cardiometabolic biomarkers in patients with rheumatoid arthritis (RA). In this randomised controlled trial 150 patients with RA were randomised to an intervention or a no-intervention control group. The intervention group received three individual motivational counselling sessions and short message service or text messages aimed at reduction of sedentary behaviour during the 16-week intervention period. Primary outcome was change in daily sitting time measured objectively by ActivPAL. Secondary outcomes included change in pain, fatigue, physical function, general self-efficacy, quality of life, blood pressure, blood lipids, haemoglobin A1c, body weight, body mass index, waist circumference and waist-hip ratio. 75 patients were allocated to each group. Mean reduction in daily sitting time was -1.61 hours/day in the intervention versus 0.59 hours/day increase in the control group between-group difference -2.20 (95% CI -2.72 to -1.69; pgroup. Most of the secondary outcomes were also in favour of the intervention. An individually tailored, behavioural intervention reduced daily sitting time in patients with RA and improved patient-reported outcomes and cholesterol levels. NCT01969604; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Protocol for an economic evaluation of the randomised controlled trial of culprit lesion only PCI versus immediate multivessel PCI in acute myocardial infarction complicated by cardiogenic shock: CULPRIT-SHOCK trial.

Science.gov (United States)

Quayyum, Zahidul; Briggs, Andrew; Robles-Zurita, Jose; Oldroyd, Keith; Zeymer, Uwe; Desch, Steffen; Waha, Suzanne de; Thiele, Holger

2017-08-18

Emergency percutaneous coronary intervention (PCI) of the culprit lesion for patients with acute myocardial infarctions is an accepted practice. A majority of patients present with multivessel disease with additional relevant stenoses apart from the culprit lesion. In haemodynamically stable patients, there is increasing evidence from randomised trials to support the practice of immediate complete revascularisation. However, in the presence of cardiogenic shock, the optimal management strategy for additional non-culprit lesions is unknown. A multicentre randomised controlled trial, CULPRIT-SHOCK, is examining whether culprit vessel only PCI with potentially subsequent staged revascularisation is more effective than immediate multivessel PCI. This paper describes the intended economic evaluation of the trial. The economic evaluation will be conducted using a pre-trial decision model and within-trial analysis. The modelling-based analysis will provide expected costs and health outcomes, and incremental cost-effectiveness ratio over the lifetime for the cohort of patients included in the trial. The within-trial analysis will provide estimates of cost per life saved at 30 days and in 1 year, and estimates of health-related quality of life. Bootstrapping and cost-effectiveness acceptability curves will be used to address any uncertainty around these estimates. Different types of regression models within a generalised estimating equation framework will be used to examine how the total cost and quality-adjusted life years are explained by patients' characteristics, revascularisation strategy, country and centre. The cost-effectiveness analysis will be from the perspective of each country's national health services, where costs will be expressed in euros adjusted for purchasing power parity. Ethical approval for the study was granted by the local Ethics Committee at each recruiting centre. The economic evaluation analyses will be published in peer-reviewed journals of

Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials

DEFF Research Database (Denmark)

Savović, J; Jones, He; Altman, Dg

2012-01-01

The design of randomised controlled trials (RCTs) should incorporate characteristics (such as concealment of randomised allocation and blinding of participants and personnel) that avoid biases resulting from lack of comparability of the intervention and control groups. Empirical evidence suggests...

Melatonin versus Placebo in Children with Autism Spectrum Conditions and Severe Sleep Problems Not Amenable to Behaviour Management Strategies: A Randomised Controlled Crossover Trial

Science.gov (United States)

Wright, Barry; Sims, David; Smart, Siobhan; Alwazeer, Ahmed; Alderson-Day, Ben; Allgar, Victoria; Whitton, Clare; Tomlinson, Heather; Bennett, Sophie; Jardine, Jenni; McCaffrey, Nicola; Leyland, Charlotte; Jakeman, Christine; Miles, Jeremy

2011-01-01

Twenty-two children with autism spectrum disorders who had not responded to supported behaviour management strategies for severe dysomnias entered a double blind, randomised, controlled crossover trial involving 3 months of placebo versus 3 months of melatonin to a maximum dose of 10 mg. 17 children completed the study. There were no significant…

BULGARIAN EMPLOYMENT POLICY: PRIORITIES AND DIRECTIONS 2017

Directory of Open Access Journals (Sweden)

Ekaterina Arabska

2017-04-01

Full Text Available Development of labor market and employment policy in Bulgaria in contemporary dynamic conditions of social and economic life is in close relation to the European policies and programs and the needs of creating conditions for raising the level of employability of some special target groups on the labor market determined as the most vulnerable and needing particular measures of support. Current study makes analyses of priorities and directions in Bulgarian national employment policy for 2017 as set into the National action plan on employment considering a number of strategic and legislative documents on both national and European level. The general conclusions are focused on the systematization of actions and the importance of social dialogue.

Women's experiences of developing musculoskeletal diseases: employment challenges and policy recommendations.

Science.gov (United States)

Crooks, Valorie A

2007-07-30

To answer three specific questions: (i) How do women experience the workplace after the onset of a musculoskeletal disease; (ii) What employment policy and programme suggestions can they offer for ways to better support chronically ill women in their abilities to maintain workforce participation; and (iii) How are these women's employment policy and programme recommendations informed by their own lived experiences and desires? In-depth interviews were conducted with 18 women who had developed musculoskeletal diseases while involved in the labour market. Data were coded and analysed thematically. Participants identified three common workplace barriers experienced and three types of workplace accommodations commonly requested. They offered four specific employment policy and programme recommendations for ways to better support women who develop musculoskeletal diseases in maintaining labour market participation. It is found that their employment policy and programme recommendations are informed by their own experiences in the workplace and desires for being supported in maintaining involvement in paid labour. Creating employment programmes and policies that support chronically ill women in their attempts to remain involved in the workforce based on how much paid labour they are able to perform and where they are best able to work is of the utmost importance.

Healthy Foundations Study: a randomised controlled trial to evaluate biological embedding of early-life experiences.

Science.gov (United States)

Gonzalez, Andrea; Catherine, Nicole; Boyle, Michael; Jack, Susan M; Atkinson, Leslie; Kobor, Michael; Sheehan, Debbie; Tonmyr, Lil; Waddell, Charlotte; MacMillan, Harriet L

2018-01-26

Adverse early experiences are associated with long-lasting disruptions in physiology, development and health. These experiences may be 'biologically embedded' into molecular and genomic systems that determine later expressions of vulnerability. Most studies to date have not examined whether preventive interventions can potentially reverse biological embedding. The Nurse-Family Partnership (NFP) is an evidence-based intervention with demonstrated efficacy in improving prenatal health, parenting and child functioning. The Healthy Foundations Study is an innovative birth cohort which will evaluate the impact of the NFP on biological outcomes of mothers and their infants. Starting in 2013, up to 400 pregnant mothers and their newborns were recruited from the British Columbia Healthy Connections Project-a randomised controlled trial of the NFP, and will be followed to child aged 2 years. Women were recruited prior to 28 weeks' gestation and then individually randomised to receive existing services (comparison group) or NFP plus existing services (intervention group). Hair samples are collected from mothers at baseline and 2 months post partum to measure physiological stress. Saliva samples are collected from infants during all visits for analyses of stress and immune function. Buccal swabs are collected from infants at 2 and 24 months to assess DNA methylation. Biological samples will be related to child outcome measures at age 2 years. The study received ethical approval from seven research ethics boards. Findings from this study will be shared broadly with the research community through peer-reviewed publications, and conference presentations, as well as seminars with our policy partners and relevant healthcare providers. The outcomes of this study will provide all stakeholders with important information regarding how early adversity may lead to health and behavioural disparities and how these may be altered through early interventions. NCT01672060; Pre-results. �

A randomised controlled trial to assess the effectiveness of a nurse-led palliative care intervention for HIV positive patients on antiretroviral therapy: recruitment, refusal, randomisation and missing data.

Science.gov (United States)

Lowther, Keira; Higginson, Irene J; Simms, Victoria; Gikaara, Nancy; Ahmed, Aabid; Ali, Zipporah; Afuande, Gaudencia; Kariuki, Hellen; Sherr, Lorraine; Jenkins, Rachel; Selman, Lucy; Harding, Richard

2014-09-03

Despite the life threatening nature of an HIV diagnosis and the multidimensional problems experienced by this patient population during antiretroviral therapy, the effectiveness of a palliative care approach for HIV positive patients on ART is as yet unknown. A randomised controlled trial (RCT) was conducted in a sample of 120 HIV positive patients on ART in an urban clinic in Mombasa, Kenya. The intervention was a minimum of seven sessions of multidimensional, person-centred care, given by HIV nurses trained in the palliative care approach over a period of 5 months. Rates of recruitment and refusal, the effectiveness of the randomisation procedure, trial follow-up and attrition and extent of missing data are reported.120 patients (60 randomised to control arm, 60 randomised to intervention arm) were recruited over 5.5 months, with a refusal rate of 55.7%. During the study period, three participants died from cancer, three withdrew (two moved away and one withdrew due to time constraints). All of these patients were in the intervention arm: details are reported. There were five additional missing monthly interviews in both the control and intervention study arm, bringing the total of missing data to 26 data points (4.3%). The quality and implications of these data are discussed extensively and openly, including the effect of full and ethical consent procedures, respondent burden, HIV stigma, accurate randomisation, patient safety and the impact of the intervention. Data on recruitment randomisation, attrition and missing data in clinical trials should be routinely reported, in conjunction with the now established practice of publishing study protocols to enhance research integrity, transparency and quality. Transparency is especially important in cross cultural settings, in which the sources of funding and trial design are often not based in the country of data collection. Findings reported can be used to inform future RCTs in this area. Clinicaltrials.gov NCT

randomised trial of alternative malaria chemoprophylaxis strategies

African Journals Online (AJOL)

hi-tech

2000-02-02

Feb 2, 2000 ... randomisation produced comparable intervention and comparison groups with balanced characteristics. Specific results of the baseline studies are presented in the companion paper. ... strategies for protecting pregnant women against malaria. ..... from malaria vaccine trial conducted among Tanzanian.

Protocol for the Mindful Student Study: a randomised controlled trial of the provision of a mindfulness intervention to support university students' well-being and resilience to stress.

Science.gov (United States)

Galante, Julieta; Dufour, Geraldine; Benton, Alice; Howarth, Emma; Vainre, Maris; Croudace, Timothy J; Wagner, Adam P; Stochl, Jan; Jones, Peter B

2016-11-09

Levels of stress in UK university students are high, with an increase in the proportion of students seeking help in recent years. Academic pressure is reported as a major trigger. Mindfulness training has been shown to reduce stress and is popular among students, but its effectiveness in this context needs to be ascertained. In this pragmatic randomised controlled trial, we hypothesise that the provision of a preventative mindfulness intervention in universities could reduce students' psychological distress during the examination period (primary outcome), improve their resilience to stress up to at least 1 year later, reduce their use of mental health support services and improve academic performance. At least 550 University of Cambridge students free from active crises or severe mental illness will be randomised to joining an 8-week mindfulness course or to mental health provision as usual (one-to-one allocation rate). Psychological distress will be measured using the Clinical Outcomes in Routine Evaluation Outcome Measure at baseline, postintervention, examination term and 1-year follow-up. Other outcomes are use of mental health services, inability to sit examinations or special circumstance requests, examination grades, well-being, altruism and coping measured with ecological momentary assessment. Outcome assessment and intention-to-treat primary analysis using linear mixed models adjusted for baseline scores will be blind to intervention allocation. We will also conduct per-protocol, subgroup and secondary outcome analyses. An Independent Data Monitoring and Ethics Committee will be set up. We will systematically monitor for, and react to, possible adverse events. An advisory reference group will comprise student representatives, members of the University Counselling Service and other student welfare staff. Approval has been obtained from Cambridge Psychology Research Ethics Committee (PRE.2015.060). Results will be published in peer-reviewed journals. A lay

Protocol for the Mindful Student Study: a randomised controlled trial of the provision of a mindfulness intervention to support university students' well-being and resilience to stress

Science.gov (United States)

Dufour, Geraldine; Benton, Alice; Howarth, Emma; Vainre, Maris; Croudace, Timothy J; Stochl, Jan; Jones, Peter B

2016-01-01

Introduction Levels of stress in UK university students are high, with an increase in the proportion of students seeking help in recent years. Academic pressure is reported as a major trigger. Mindfulness training has been shown to reduce stress and is popular among students, but its effectiveness in this context needs to be ascertained. In this pragmatic randomised controlled trial, we hypothesise that the provision of a preventative mindfulness intervention in universities could reduce students' psychological distress during the examination period (primary outcome), improve their resilience to stress up to at least 1 year later, reduce their use of mental health support services and improve academic performance. Methods and analysis At least 550 University of Cambridge students free from active crises or severe mental illness will be randomised to joining an 8-week mindfulness course or to mental health provision as usual (one-to-one allocation rate). Psychological distress will be measured using the Clinical Outcomes in Routine Evaluation Outcome Measure at baseline, postintervention, examination term and 1-year follow-up. Other outcomes are use of mental health services, inability to sit examinations or special circumstance requests, examination grades, well-being, altruism and coping measured with ecological momentary assessment. Outcome assessment and intention-to-treat primary analysis using linear mixed models adjusted for baseline scores will be blind to intervention allocation. We will also conduct per-protocol, subgroup and secondary outcome analyses. An Independent Data Monitoring and Ethics Committee will be set up. We will systematically monitor for, and react to, possible adverse events. An advisory reference group will comprise student representatives, members of the University Counselling Service and other student welfare staff. Ethics and dissemination Approval has been obtained from Cambridge Psychology Research Ethics Committee (PRE.2015

Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial.

Science.gov (United States)

Turner, Deborah E; Helliwell, Philip S; Woodburn, James

2007-11-06

Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA) related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT) to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Patients with a definite diagnosis of RA, stable drug management 3 months prior to entry, and a current history of foot problems (pain, deformity, stiffness, skin or nail lesions, or footwear problems) were recruited from a hospital outpatient rheumatology clinic and randomised to receive 12 months of podiatry treatment or no care. The primary outcome was change in foot health status using the impairment/footwear (LFISIF) and activity limitation/participation restriction (LFISAP) subscales of the Leeds Foot Impact Scale. Disease Activity Score (DAS), Health Assessment Questionnaire (HAQ) score and walking speed (m/s) were also recorded. Of the 80 patients identified, 64 patients were eligible to participate in the pilot and 34 were recruited. 16 patients were randomised to receive podiatry led foot care and 18 received no care. Against a backdrop of stable disease (DAS and HAQ scores), there was a statistically significant between group difference in the change in foot health status for foot impairment (LFISIF) but not activity/participation (LFISAP) or function (walking speed) over 12 months. In the podiatry arm, 1 patient declined treatment following randomisation (did not want additional hospital visits) and 3 self-withdrew (lost to follow-up). Patients received an average of 3 consultations for assessment and treatment comprising routine care for skin and nail lesions (n = 3), foot orthoses (n = 9), footwear referral to the orthotist (n = 5), and ultrasound guided intra-articular steroid injection

Case and Administrative Support Tools

Science.gov (United States)

Case and Administrative Support Tools (CAST) is the secure portion of the Office of General Counsel (OGC) Dashboard business process automation tool used to help reduce office administrative labor costs while increasing employee effectiveness. CAST supports business functions which rely on and store Privacy Act sensitive data (PII). Specific business processes included in CAST (and respective PII) are: -Civil Rights Cast Tracking (name, partial medical history, summary of case, and case correspondance). -Employment Law Case Tracking (name, summary of case). -Federal Tort Claims Act Incident Tracking (name, summary of incidents). -Ethics Program Support Tools and Tracking (name, partial financial history). -Summer Honors Application Tracking (name, home address, telephone number, employment history). -Workforce Flexibility Initiative Support Tools (name, alternative workplace phone number). -Resource and Personnel Management Support Tools (name, partial employment and financial history).

The ANKLE TRIAL (ANKLE treatment after injuries of the ankle ligaments: what is the benefit of external support devices in the functional treatment of acute ankle sprain? : a randomised controlled trial

Directory of Open Access Journals (Sweden)

Witjes Suzanne

2012-02-01

Full Text Available Abstract Background Acute lateral ankle ligament injuries are very common problems in present health care. Still there is no hard evidence about which treatment strategy is superior. Current evidence supports the view that a functional treatment strategy is preferable, but insufficient data are present to prove the benefit of external support devices in these types of treatment. The hypothesis of our study is that external ankle support devices will not result in better outcome in the treatment of acute ankle sprains, compared to a purely functional treatment strategy. Overall objective is to compare the results of three different strategies of functional treatment for acute ankle sprain, especially to determine the advantages of external support devices in addition to functional treatment strategy, based on balance and coordination exercises. Methods/design This study is designed as a randomised controlled multi-centre trial with one-year follow-up. Adult and healthy patients (N = 180 with acute, single sided and first inversion trauma of the lateral ankle ligaments will be included. They will all follow the same schedule of balancing exercises and will be divided into 3 treatment groups, 1. pressure bandage and tape, 2. pressure bandage and brace and 3. no external support. Primary outcome measure is the Karlsson scoring scale; secondary outcomes are FAOS (subscales, number of recurrent ankle injuries, Visual Analogue Scales of pain and satisfaction and adverse events. They will be measured after one week, 6 weeks, 6 months and 1 year. Discussion The ANKLE TRIAL is a randomized controlled trial in which a purely functional treated control group, without any external support is investigated. Results of this study could lead to other opinions about usefulness of external support devices in the treatment of acute ankle sprain. Trial registration Netherlands Trial Register (NTR: NTR2151

The ANKLE TRIAL (ANKLE treatment after injuries of the ankle ligaments): what is the benefit of external support devices in the functional treatment of acute ankle sprain? : a randomised controlled trial

Science.gov (United States)

2012-01-01

Background Acute lateral ankle ligament injuries are very common problems in present health care. Still there is no hard evidence about which treatment strategy is superior. Current evidence supports the view that a functional treatment strategy is preferable, but insufficient data are present to prove the benefit of external support devices in these types of treatment. The hypothesis of our study is that external ankle support devices will not result in better outcome in the treatment of acute ankle sprains, compared to a purely functional treatment strategy. Overall objective is to compare the results of three different strategies of functional treatment for acute ankle sprain, especially to determine the advantages of external support devices in addition to functional treatment strategy, based on balance and coordination exercises. Methods/design This study is designed as a randomised controlled multi-centre trial with one-year follow-up. Adult and healthy patients (N = 180) with acute, single sided and first inversion trauma of the lateral ankle ligaments will be included. They will all follow the same schedule of balancing exercises and will be divided into 3 treatment groups, 1. pressure bandage and tape, 2. pressure bandage and brace and 3. no external support. Primary outcome measure is the Karlsson scoring scale; secondary outcomes are FAOS (subscales), number of recurrent ankle injuries, Visual Analogue Scales of pain and satisfaction and adverse events. They will be measured after one week, 6 weeks, 6 months and 1 year. Discussion The ANKLE TRIAL is a randomized controlled trial in which a purely functional treated control group, without any external support is investigated. Results of this study could lead to other opinions about usefulness of external support devices in the treatment of acute ankle sprain. Trial registration Netherlands Trial Register (NTR): NTR2151 PMID:22340371

Feasibility of a multicentre, randomised controlled trial of laparoscopic versus open colorectal surgery in the acute setting: the LaCeS feasibility trial protocol.

Science.gov (United States)

Harji, Deena; Marshall, Helen; Gordon, Katie; Crow, Hannah; Hiley, Victoria; Burke, Dermot; Griffiths, Ben; Moriarty, Catherine; Twiddy, Maureen; O'Dwyer, John L; Verjee, Azmina; Brown, Julia; Sagar, Peter

2018-02-22

Acute colorectal surgery forms a significant proportion of emergency admissions within the National Health Service. There is limited evidence to suggest minimally invasive surgery may be associated with improved clinical outcomes in this cohort of patients. Consequently, there is a need to assess the clinical effectiveness and cost-effectiveness of laparoscopic surgery in the acute colorectal setting. However,emergency colorectal surgical trials have previously been difficult to conduct due to issues surrounding recruitment and equipoise. The LaCeS (randomised controlled trial of Laparoscopic versus open Colorectal Surgery in the acute setting) feasibility trial will determine the feasibility of conducting a definitive, phase III trial of laparoscopic versus open acute colorectal resection. The LaCeS feasibility trial is a prospective, multicentre, single-blinded, parallel group, pragmatic randomised controlled feasibility trial. Patients will be randomised on a 1:1 basis to receive eitherlaparoscopic or open surgery. The trial aims to recruit at least 66 patients from five acute general surgical units across the UK. Patients over the age of 18 with a diagnosis of acute colorectal pathology requiring resection on clinical and radiological/endoscopic investigations, with a National Confidential Enquiry into Patient Outcome and Death classification of urgent will be considered eligible for participation. The primary outcome is recruitment. Secondary outcomes include assessing the safety profile of laparoscopic surgery using intraoperative and postoperative complication rates, conversion rates and patient-safety indicators as surrogate markers. Clinical and patient-reported outcomes will also be reported. The trial will contain an embedded qualitative study to assess clinician and patient acceptability of trial processes. The LaCeS feasibility trial is approved by the Yorkshire and The Humber, Bradford Leeds Research Ethics Committee (REC reference: 15/ YH/0542). The

Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial

OpenAIRE

Turner, Deborah E; Helliwell, Philip S; Woodburn, James

2007-01-01

Abstract Background Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA) related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT) to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Method...

A qualitative analysis of trainer/coach experiences of changing care home practice in the Well-being and Health in Dementia randomised control trial.

Science.gov (United States)

Fossey, Jane; Garrod, Lucy; Guzman, Azucena; Testad, Ingelin

2018-01-01

Objectives This study explored the experiences of a range of health and social care professionals employed in the role of trainer/coaches to support care home staff to implement a psychosocial intervention for residents living with dementia. It aimed to identify the factors which are pertinent to these roles, in the context of a cascade model of training. Method A focus group was convened involving dementia trainer/coaches and supervisors who had worked on Well-being and Health for people with Dementia randomised control trial. Twelve participants explored their preparedness for and experiences of their role as 'Well-being and Health for people with Dementia therapists'. They reflected on their perceptions of the resources and support required. The data were transcribed verbatim and subjected to inductive thematic analysis. Results Three main themes emerged from the data. Within the theme of 'skills in relationship building' were two subthemes of developing trust and getting to know individual staff and each care home. In the second main theme of 'making use of tangible resources' two subthemes relating to using the Well-being and Health for people with Dementia manuals and the supervision of the therapists arose. The third theme, 'being an agent for change' contained three subthemes: effective training methods, creating opportunities for Dementia Champions to reflect and therapists' perceived rewards of their role. Conclusion The findings provide new insights into the trainer/coach role applicable to the practices of services recruiting, training and providing ongoing professional support to practitioners in-reaching into care homes.

Hearing loss and employment in the United States.

Science.gov (United States)

Kooser, Cathy

2013-01-01

This Sounding Board article will briefly review the biopsychosocial impact of hearing loss. It will consider the individual and employment; the laws supporting employment and the current vocational rehabilitation system assisting people with hearing loss remain in the workplace. It concludes with the author's suggestion of three systematic changes to enhance the employee's workplace success.

Detailed systematic analysis of recruitment strategies in randomised controlled trials in patients with an unscheduled admission to hospital.

Science.gov (United States)

Rowlands, Ceri; Rooshenas, Leila; Fairhurst, Katherine; Rees, Jonathan; Gamble, Carrol; Blazeby, Jane M

2018-02-02

To examine the design and findings of recruitment studies in randomised controlled trials (RCTs) involving patients with an unscheduled hospital admission (UHA), to consider how to optimise recruitment in future RCTs of this nature. Studies within the ORRCA database (Online Resource for Recruitment Research in Clinical TriAls; www.orrca.org.uk) that reported on recruitment to RCTs involving UHAs in patients >18 years were included. Extracted data included trial clinical details, and the rationale and main findings of the recruitment study. Of 3114 articles populating ORRCA, 39 recruitment studies were eligible, focusing on 68 real and 13 hypothetical host RCTs. Four studies were prospectively planned investigations of recruitment interventions, one of which was a nested RCT. Most recruitment papers were reports of recruitment experiences from one or more 'real' RCTs (n=24) or studies using hypothetical RCTs (n=11). Rationales for conducting recruitment studies included limited time for informed consent (IC) and patients being too unwell to provide IC. Methods to optimise recruitment included providing patients with trial information in the prehospital setting, technology to allow recruiters to cover multiple sites, screening logs to uncover recruitment barriers, and verbal rather than written information and consent. There is a paucity of high-quality research into recruitment in RCTs involving UHAs with only one nested randomised study evaluating a recruitment intervention. Among the remaining studies, methods to optimise recruitment focused on how to improve information provision in the prehospital setting and use of screening logs. Future research in this setting should focus on the prospective evaluation of the well-developed interventions to optimise recruitment. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Educational outreach to general practitioners reduces children's asthma symptoms: a cluster randomised controlled trial

Directory of Open Access Journals (Sweden)

Sladden Michael

2007-09-01

Full Text Available Abstract Background Childhood asthma is common in Cape Town, a province of South Africa, but is underdiagnosed by general practitioners. Medications are often prescribed inappropriately, and care is episodic. The objective of this study is to assess the impact of educational outreach to general practitioners on asthma symptoms of children in their practice. Methods This is a cluster randomised trial with general practices as the unit of intervention, randomisation, and analysis. The setting is Mitchells Plain (population 300,000, a dormitory town near Cape Town. Solo general practitioners, without nurse support, operate from storefront practices. Caregiver-reported symptom data were collected for 318 eligible children (2 to 17 years with moderate to severe asthma, who were attending general practitioners in Mitchells Plain. One year post-intervention follow-up data were collected for 271 (85% of these children in all 43 practices. Practices randomised to intervention (21 received two 30-minute educational outreach visits by a trained pharmacist who left materials describing key interventions to improve asthma care. Intervention and control practices received the national childhood asthma guideline. Asthma severity was measured in a parent-completed survey administered through schools using a symptom frequency and severity scale. We compared intervention and control group children on the change in score from pre-to one-year post-intervention. Results Symptom scores declined an additional 0.84 points in the intervention vs. control group (on a nine-point scale. p = 0.03. For every 12 children with asthma exposed to a doctor allocated to the intervention, one extra child will have substantially reduced symptoms. Conclusion Educational outreach was accepted by general practitioners and was effective. It could be applied to other health care quality problems in this setting.

Group art therapy as an adjunctive treatment for people with schizophrenia: a randomised controlled trial (MATISSE).

OpenAIRE

Crawford, MJ; Killaspy, H; Barnes, TR; Barrett, B; Byford, S; Clayton, K; Dinsmore, J; Floyd, S; Hoadley, A; Johnson, T; Kalaitzaki, E; King, M; Leurent, B; Maratos, A; O'Neill, FA

2012-01-01

OBJECTIVE To examine the clinical effectiveness and cost-effectiveness of referral to group art therapy plus standard care, compared with referral to an activity group plus standard care and standard care alone, among people with schizophrenia. DESIGN A three-arm, parallel group, single-blind, pragmatic, randomised controlled trial. Participants were randomised via an independent and remote telephone randomisation service using permuted blocks, stratified by study centre. SETTING Study partic...

Development of a framework to improve the process of recruitment to randomised controlled trials (RCTs): the SEAR (Screened, Eligible, Approached, Randomised) framework.

Science.gov (United States)

Wilson, Caroline; Rooshenas, Leila; Paramasivan, Sangeetha; Elliott, Daisy; Jepson, Marcus; Strong, Sean; Birtle, Alison; Beard, David J; Halliday, Alison; Hamdy, Freddie C; Lewis, Rebecca; Metcalfe, Chris; Rogers, Chris A; Stein, Robert C; Blazeby, Jane M; Donovan, Jenny L

2018-01-19

Research has shown that recruitment to trials is a process that stretches from identifying potentially eligible patients, through eligibility assessment, to obtaining informed consent. The length and complexity of this pathway means that many patients do not have the opportunity to consider participation. This article presents the development of a simple framework to document, understand and improve the process of trial recruitment. Eight RCTs integrated a QuinteT Recruitment Intervention (QRI) into the main trial, feasibility or pilot study. Part of the QRI required mapping the patient recruitment pathway using trial-specific screening and recruitment logs. A content analysis compared the logs to identify aspects of the recruitment pathway and process that were useful in monitoring and improving recruitment. Findings were synthesised to develop an optimised simple framework that can be used in a wide range of RCTs. The eight trials recorded basic information about patients screened for trial participation and randomisation outcome. Three trials systematically recorded reasons why an individual was not enrolled in the trial, and further details why they were not eligible or approached, or declined randomisation. A framework to facilitate clearer recording of the recruitment process and reasons for non-participation was developed: SEAR - Screening, to identify potentially eligible trial participants; Eligibility, assessed against the trial protocol inclusion/exclusion criteria; Approach, the provision of oral and written information and invitation to participate in the trial, and Randomised or not, with the outcome of randomisation or treatment received. The SEAR framework encourages the collection of information to identify recruitment obstacles and facilitate improvements to the recruitment process. SEAR can be adapted to monitor recruitment to most RCTs, but is likely to add most value in trials where recruitment problems are anticipated or evident. Further work

Comparing standard office-based follow-up with text-based remote monitoring in the management of postpartum hypertension: a randomised clinical trial.

Science.gov (United States)

Hirshberg, Adi; Downes, Katheryne; Srinivas, Sindhu

2018-04-27

Monitoring blood pressure at 72 hours and 7-10 days post partum in women with hypertensive disorders is recommended to decrease morbidity. However, there are no recommendations as to how to achieve this. To compare the effectiveness of text-based blood pressure monitoring to in-person visits for women with hypertensive disorders of pregnancy in the immediate postpartum period. Randomised clinical trial among 206 postpartum women with pregnancy-related hypertension diagnosed during the delivery admission between August 2016 and January 2017. Women were randomised to 2 weeks of text-based surveillance using a home blood pressure cuff and previously tested automated platform or usual care blood pressure check at their prenatal clinic 4-6 days following discharge. The primary study outcome was a single recorded blood pressure in the first 10 days post partum. The ability to meet American Congress of Obstetricians and Gynecologists (ACOG) guidelines, defined as having a blood pressure recorded on postpartum days 3-4 and 7-10 was evaluated in the text message group. The study was powered to detect a 1.4-fold increase in a single recorded blood pressure using text messaging. All outcomes were analysed as intention to treat. 206 women were randomised (103 in each arm). Baseline characteristics were similar. There was a statistically significant increase in a single blood pressure obtained in the texting group in the first 10 days post partum as compared with the office group (92.2% vs 43.7%; adjusted OR 58.2 (16.2-208.1), p<0.001). Eighty-four per cent of patients undergoing text-based surveillance met ACOG criteria for blood pressures at both recommended points. Text-based monitoring is more effective in obtaining blood pressures and meeting current clinical guidelines in the immediate postdischarge period in women with pregnancy-related hypertension compared with traditional office-based follow-up. NCT03185455, Remote Surveillance of Postpartum Hypertension (Text

Does Maternal Employment Following Childbirth Support or Inhibit Low-Income Children’s Long-Term Development?

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Coley, Rebekah Levine; Lombardi, Caitlin McPherran

2012-01-01

This study assessed whether previous findings linking early maternal employment to lower cognitive and behavioral skills among middle class and White children generalized to other groups. Using a representative sample of urban, low-income, predominantly African American and Hispanic families (n = 444), OLS regression and propensity score matching models assessed links between maternal employment in the two years after childbearing and children’s functioning at age 7. Children whose mothers were employed early, particularly in their first 8 months, showed enhanced socio-emotional functioning compared to peers whose mother remained nonemployed. Protective associations emerged for both part time and full time employment, and were driven by African American children, with neutral effects for Hispanics. Informal home-based child care also heightened positive links. PMID:22931466

ICT-based Innovation and Employability for Women

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Marios A Pappas

2017-06-01

Full Text Available The utilization of ICTs in creating new jobs and eliminating gender based inequalities in employability and entrepreneurship, employs increasingly more researchers, governments and organizations around the world. In this article we analyze the current situation regarding the impact of ICTs, social networks and media on creating new opportunities for the employability of women. We also present the new market requirements, the new e-skills that will be acquired by women in order to take advantage of new labor market opportunities. Finally special reference is made to new trends in women's entrepreneurship as well as the supportive role of ICTs.

A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034

Science.gov (United States)

2012-01-01

Background Negative pressure wound therapy (NPWT) is widely promoted as a treatment for full thickness wounds; however, there is a lack of high-quality research evidence regarding its clinical and cost effectiveness. A trial of NPWT for the treatment of grade III/IV pressure ulcers would be worthwhile but premature without assessing whether such a trial is feasible. The aim of this pilot randomised controlled trial was to assess the feasibility of conducting a future full trial of NPWT for the treatment of grade III and IV pressure ulcers and to pilot all aspects of the trial. Methods This was a two-centre (acute and community), pilot randomised controlled trial. Eligible participants were randomised to receive either NPWT or standard care (SC) (spun hydrocolloid, alginate or foam dressings). Outcome measures were time to healing of the reference pressure ulcer, recruitment rates, frequency of treatment visits, resources used and duration of follow-up. Results Three hundred and twelve patients were screened for eligibility into this trial over a 12-month recruitment period and 12/312 participants (3.8%) were randomised: 6 to NPWT and 6 to SC. Only one reference pressure ulcer healed (NPWT group) during follow-up (time to healing 79 days). The mean number of treatment visits per week was 3.1 (NPWT) and 5.7 (SC); 6/6 NPWT and 1/6 SC participants withdrew from their allocated trial treatment. The mean duration of follow-up was 3.8 (NPWT) and 5.0 (SC) months. Conclusions This pilot trial yielded vital information for the planning of a future full study including projected recruitment rate, required duration of follow-up and extent of research nurse support required. Data were also used to inform the cost-effectiveness and value of information analyses, which were conducted alongside the pilot trial. Trial registration Current Controlled Trials ISRCTN69032034. PMID:22839453

A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034

Directory of Open Access Journals (Sweden)

Ashby Rebecca L

2012-07-01

Full Text Available Abstract Background Negative pressure wound therapy (NPWT is widely promoted as a treatment for full thickness wounds; however, there is a lack of high-quality research evidence regarding its clinical and cost effectiveness. A trial of NPWT for the treatment of grade III/IV pressure ulcers would be worthwhile but premature without assessing whether such a trial is feasible. The aim of this pilot randomised controlled trial was to assess the feasibility of conducting a future full trial of NPWT for the treatment of grade III and IV pressure ulcers and to pilot all aspects of the trial. Methods This was a two-centre (acute and community, pilot randomised controlled trial. Eligible participants were randomised to receive either NPWT or standard care (SC (spun hydrocolloid, alginate or foam dressings. Outcome measures were time to healing of the reference pressure ulcer, recruitment rates, frequency of treatment visits, resources used and duration of follow-up. Results Three hundred and twelve patients were screened for eligibility into this trial over a 12-month recruitment period and 12/312 participants (3.8% were randomised: 6 to NPWT and 6 to SC. Only one reference pressure ulcer healed (NPWT group during follow-up (time to healing 79 days. The mean number of treatment visits per week was 3.1 (NPWT and 5.7 (SC; 6/6 NPWT and 1/6 SC participants withdrew from their allocated trial treatment. The mean duration of follow-up was 3.8 (NPWT and 5.0 (SC months. Conclusions This pilot trial yielded vital information for the planning of a future full study including projected recruitment rate, required duration of follow-up and extent of research nurse support required. Data were also used to inform the cost-effectiveness and value of information analyses, which were conducted alongside the pilot trial. Trial registration Current Controlled Trials ISRCTN69032034.

Infant feeding bottle design, growth and behaviour: results from a randomised trial

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Fewtrell MS

2012-03-01

Full Text Available Abstract Background Whether the design of an anti-vacuum infant feeding bottle influences infant milk intake, growth or behavior is unknown, and was the subject of this randomized trial. Methods Subjects 63 (36 male healthy, exclusively formula-fed term infants. Intervention Randomisation to use Bottle A (n = 31, one-way air valve: Philips Avent versus Bottle B (n = 32, internal venting system: Dr Browns. 74 breast-fed reference infants were recruited, with randomisation (n = 24 to bottle A (n = 11 or B (n = 13 if bottle-feeding was subsequently introduced. Randomisation stratified by gender and parity; computer-based telephone randomisation by independent clinical trials unit. Setting Infant home. Primary outcome measure infant weight gain to 4 weeks. Secondary outcomes (i milk intake (ii infant behaviour measured at 2 weeks (validated 3-day diary; (iii risk of infection; (iv continuation of breastfeeding following introduction of mixed feeding. Results Number analysed for primary outcome Bottle A n = 29, Bottle B n = 25. Primary outcome There was no significant difference in weight gain between randomised groups (0-4 weeks Bottle A 0.74 (SD 1.2 SDS versus bottle B 0.51 (0.39, mean difference 0.23 (95% CI -0.31 to 0.77. Secondary outcomes Infants using bottle A had significantly less reported fussing (mean 46 versus 74 minutes/day, p Breast-fed reference group There were no significant differences in primary or secondary outcomes between breast-fed and formula fed infants. The likelyhood of breastfeeding at 3 months was not significantly different in infants subsequently randomised to bottle A or B. Conclusion Bottle design may have short-term effects on infant behaviour which merit further investigation. No significant effects were seen on milk intake or growth; confidence in these findings is limited by the small sample size and this needs confirmation in a larger study. Trial registration Clinical Trials.gov NCT00325208.

Social firms: sustainable employment for people with mental illness.

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Williams, Anne; Fossey, Ellie; Harvey, Carol

2012-01-01

Social firms or enterprises aim to offer sustainable employment in supportive workplaces for people who are disadvantaged in the labour market. Therefore, this study sought to explore employees' views in one social firm about the features of their workplace that they found supportive. Seven employees were recruited, all of whom experienced persistent mental illness, and had worked in this social firm for between eleven months and six years. A semi-structured interview, the Work Environment Impact Scale (version 2.0), was used to explore participants' views of their workplace and to rate how its physical and social characteristics impacted them. Participants also rated their job satisfaction with a modified Indiana Job Satisfaction Scale. Features of the social firm workplace identified by these employees as contributing to their sustained employment and satisfaction were the rewards, task demands, work schedule, and workplace interactions with supervisors and other co-workers. From their views, guiding principles for the development of supportive workplaces and evaluation of their capacity to afford sustainable employment were derived. This study adds to current knowledge about workplace supports from an employee perspective, and is of relevance for informing future social firm development, workplace design and evaluation.

GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING): a pilot cluster randomised controlled trial of a guideline implementation intervention for the management of maternal obesity by midwives.

Science.gov (United States)

Heslehurst, Nicola; Rankin, Judith; McParlin, Catherine; Sniehotta, Falko F; Howel, Denise; Rice, Stephen; McColl, Elaine

2018-01-01

Weight management in pregnancy guidelines exist, although dissemination alone is an ineffective means of implementation. Midwives identify the need for support to overcome complex barriers to practice. An evaluation of an intervention to support midwives' guideline implementation would require a large-scale cluster randomised controlled trial. A pilot study is necessary to explore the feasibility of delivery and evaluation prior to a definitive trial. The GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING) trial aims to test whether it is feasible and acceptable to deliver a behaviour change intervention to support midwives' implementation of weight management guidelines. GLOWING is a multi-centre parallel group pilot cluster randomised controlled trial comparing the delivery of a behaviour change intervention for midwives versus usual practice. Four NHS Trusts (clusters) will be randomised to intervention and control arms, stratified by size of maternity services. The intervention uses social cognitive theory and consists of face-to-face midwifery training plus information resources for routine practice. The main outcomes are whether the intervention and trial procedures are feasible and acceptable to participants and the feasibility of recruitment and data collection for a definitive trial. Target recruitment involves all eligible midwives in the intervention arm recruited to receive the intervention, 30 midwives and pregnant women per arm for baseline and outcome questionnaire data collection and 20 midwives and women to provide qualitative data. All quantitative and qualitative analyses will be descriptive with the purpose of informing the development of the definitive trial. This pilot study has been developed to support community midwives' implementation of guidelines. Community midwives have been selected as they usually carry out the booking appointment which includes measuring and discussing maternal body mass index. A

CESAR: conventional ventilatory support vs extracorporeal membrane oxygenation for severe adult respiratory failure

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Mugford Miranda

2006-12-01

Full Text Available Abstract Background An estimated 350 adults develop severe, but potentially reversible respiratory failure in the UK annually. Current management uses intermittent positive pressure ventilation, but barotrauma, volutrauma and oxygen toxicity can prevent lung recovery. An alternative treatment, extracorporeal membrane oxygenation, uses cardio-pulmonary bypass technology to temporarily provide gas exchange, allowing ventilator settings to be reduced. While extracorporeal membrane oxygenation is proven to result in improved outcome when compared to conventional ventilation in neonates with severe respiratory failure, there is currently no good evidence from randomised controlled trials to compare these managements for important clinical outcomes in adults, although evidence from case series is promising. Methods/Design The aim of the randomised controlled trial of Conventional ventilatory support vs extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR is to assess whether, for patients with severe, but potentially reversible, respiratory failure, extracorporeal membrane oxygenation will increase the rate of survival without severe disability ('confined to bed' and 'unable to wash or dress' by six months post-randomisation, and be cost effective from the viewpoints of the NHS and society, compared to conventional ventilatory support. Following assent from a relative, adults (18–65 years with severe, but potentially reversible, respiratory failure (Murray score ≥ 3.0 or hypercapnea with pH Discussion Analysis will be based on intention to treat. A concurrent economic evaluation will also be performed to compare the costs and outcomes of both treatments.

The perceived employability of ex-prisoners and offenders.

Science.gov (United States)

Graffam, Joseph; Shinkfield, Alison J; Hardcastle, Lesley

2008-12-01

A large-scale study was conducted to examine the perceived employability of ex-prisoners and offenders. Four participant groups comprising 596 (50.4%) employers, 234 (19.8%) employment service workers, 176 (14.9%) corrections workers, and 175 (14.8%) prisoners and offenders completed a questionnaire assessing the likelihood of a hypothetical job seeker's both obtaining and maintaining employment; the importance of specific skills and characteristics to employability; and the likelihood that ex-prisoners, offenders, and the general workforce exhibit these skills and characteristics. Apart from people with an intellectual or psychiatric disability, those with a criminal background were rated as being less likely than other disadvantaged groups to obtain and maintain employment. In addition, ex-prisoners were rated as being less likely than offenders and the general workforce to exhibit the skills and characteristics relevant to employability. Implications for the preparation and support of ex-prisoners and offenders into employment are discussed, together with broader community-wide initiatives to promote reintegration.

Policy Analysis on Growth and Employment - PAGE II | IDRC ...

International Development Research Centre (IDRC) Digital Library (Canada)

Policy Analysis on Growth and Employment - PAGE II. This project by the Partnership for Economic Policy (PEP) will support quality ... The project is supported by the UK's Department for International Development, and additional funding is ...

Beating the blues after Cancer: randomised controlled trial of a tele-based psychological intervention for high distress patients and carers

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Hutchison Sandy

2009-06-01

Full Text Available Abstract Background The diagnosis and treatment of cancer is a major life stress such that approximately 35% of patients experience persistent clinically significant distress and carers often experience even higher distress than patients. This paper presents the design of a two arm randomised controlled trial with patients and carers who have elevated psychological distress comparing minimal contact self management vs. an individualised tele-based cognitive behavioural intervention. Methods/design 140 patients and 140 carers per condition (560 participants in total will been recruited after being identified as high distress through caller screening at two community-based cancer helplines and randomised to 1 a single 30-minute telephone support and education session with a nurse counsellor with self management materials 2 a tele-based psychologist delivered five session individualised cognitive behavioural intervention. Session components will include stress reduction, problem-solving, cognitive challenging and enhancing relationship support and will be delivered weekly. Participants will be assessed at baseline and 3, 6 and 12 months after recruitment. Outcome measures include: anxiety and depression, cancer specific distress, unmet psychological supportive care needs, positive adjustment, overall Quality of life. Discussion The study will provide recommendations about the efficacy and potential economic value of minimal contact self management vs. tele-based psychologist delivered cognitive behavioural intervention to facilitate better psychosocial adjustment and mental health for people with cancer and their carers. Trial Registration ACTRN12609000301268.

Plasma urate concentration and risk of coronary heart disease: a Mendelian randomisation analysis

Science.gov (United States)

White, Jon; Sofat, Reecha; Hemani, Gibran; Shah, Tina; Engmann, Jorgen; Dale, Caroline; Shah, Sonia; Kruger, Felix A; Giambartolomei, Claudia; Swerdlow, Daniel I; Palmer, Tom; McLachlan, Stela; Langenberg, Claudia; Zabaneh, Delilah; Lovering, Ruth; Cavadino, Alana; Jefferis, Barbara; Finan, Chris; Wong, Andrew; Amuzu, Antoinette; Ong, Ken; Gaunt, Tom R; Warren, Helen; Davies, Teri-Louise; Drenos, Fotios; Cooper, Jackie; Ebrahim, Shah; Lawlor, Debbie A; Talmud, Philippa J; Humphries, Steve E; Power, Christine; Hypponen, Elina; Richards, Marcus; Hardy, Rebecca; Kuh, Diana; Wareham, Nicholas; Ben-Shlomo, Yoav; Day, Ian N; Whincup, Peter; Morris, Richard; Strachan, Mark W J; Price, Jacqueline; Kumari, Meena; Kivimaki, Mika; Plagnol, Vincent; Whittaker, John C; Smith, George Davey; Dudbridge, Frank; Casas, Juan P; Holmes, Michael V; Hingorani, Aroon D

2016-01-01

Summary Background Increased circulating plasma urate concentration is associated with an increased risk of coronary heart disease, but the extent of any causative effect of urate on risk of coronary heart disease is still unclear. In this study, we aimed to clarify any causal role of urate on coronary heart disease risk using Mendelian randomisation analysis. Methods We first did a fixed-effects meta-analysis of the observational association of plasma urate and risk of coronary heart disease. We then used a conventional Mendelian randomisation approach to investigate the causal relevance using a genetic instrument based on 31 urate-associated single nucleotide polymorphisms (SNPs). To account for potential pleiotropic associations of certain SNPs with risk factors other than urate, we additionally did both a multivariable Mendelian randomisation analysis, in which the genetic associations of SNPs with systolic and diastolic blood pressure, HDL cholesterol, and triglycerides were included as covariates, and an Egger Mendelian randomisation (MR-Egger) analysis to estimate a causal effect accounting for unmeasured pleiotropy. Findings In the meta-analysis of 17 prospective observational studies (166 486 individuals; 9784 coronary heart disease events) a 1 SD higher urate concentration was associated with an odds ratio (OR) for coronary heart disease of 1·07 (95% CI 1·04–1·10). The corresponding OR estimates from the conventional, multivariable adjusted, and Egger Mendelian randomisation analysis (58 studies; 198 598 individuals; 65 877 events) were 1·18 (95% CI 1·08–1·29), 1·10 (1·00–1·22), and 1·05 (0·92–1·20), respectively, per 1 SD increment in plasma urate. Interpretation Conventional and multivariate Mendelian randomisation analysis implicates a causal role for urate in the development of coronary heart disease, but these estimates might be inflated by hidden pleiotropy. Egger Mendelian randomisation analysis, which accounts for

Refusal of implant supported mandibular overdentures by elderly patients.

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Ellis, Janice S; Levine, Alissa; Bedos, Christophe; Mojon, Phillippe; Rosberger, Zeer; Feine, Jocelyne; Thomason, J Mark

2011-03-01

  The aim of this study was to gain greater in-depth understanding of why elderly patients who are currently dissatisfied with conventional dentures decline implant treatment.   There is strong evidence from high-quality randomised controlled trials to support the use of implant-supported overdentures for the restoration of the edentulous mandible. However, whilst recruiting for randomised clinical trials, researchers have found that a high proportion of potential subjects decline participation, despite the removal of financial constraints.   The study adopted a qualitative approach to provide a rich and deep understanding of people's reasons for refusal. Data were collected through focus group interviews in a two-centre study based in Montreal, Canada and Newcastle, UK. A semi-structured interview schedule was used and iteratively developed as analysis identified themes from previous focus groups. Transcripts of focus groups were coded and emergent themes determined.   Two main themes emerged; patients' fear and anxiety (relating to the pain of surgery, complications of the procedure and immediate post-surgical denture use), and the appropriateness of the procedure in an elderly person.   Fears of pain, complications and social embarrassment, exacerbated by age, are important factors that help explain refusal of implants by elderly patients. © 2010 The Gerodontology Society and John Wiley & Sons A/S.

Factors affecting the employability in people with epilepsy.

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Wo, Monica Chen Mun; Lim, Kheng Seang; Choo, Wan Yuen; Tan, Chong Tin

2016-12-01

People with epilepsy (PWE) are negatively prejudiced in their ability to work. This study aimed to examine demographic, clinical and psychological factors associated with employability in PWE. This study recruited epilepsy patients from a neurology clinic in Malaysia. Employability was measured using employment ratio, with a ratio ≥90% (ER90) classified as high employability. Basic demographic data such as age, gender, marital status, religion, education level and household income was collected. Clinical measures consisted of age of seizure onset, seizure frequency, type of epilepsy, aura, polytherapy, nocturnal seizures and seizure control. Psychological measures included Work Self-Determination Index (WSDI), Rosenberg Self-Esteem Scale (SES), and Multidimensional Scale of Perceived Social Support (MSPSS). Of 146 PWE, 64.4% had high employability. The participants were predominantly female (52%), Chinese (50.7%), single (50%), having tertiary education (55.5%) and focal epilepsy (72.6%). Clinically, only type of epilepsy was significantly correlated to employability of PWE. Employability of PWE was associated with ability to work (indicated by education level, work performance affected by seizures, ability to travel independently and ability to cope with stress at work) and family overprotection. The high employability group was found to have lower self-perceived stigma (ESS), higher self-determined motivation (WSDI), self-esteem (SES) and perceived social support (MSPSS), than the low employability group. Logistic regression analysis showed that tertiary education level (AOR 3.42, CI: 1.46-8.00), higher self-determination (WSDI, AOR 1.09, CI: 1.012-1.17), lower family overprotection (AOR 0.76, CI: 0.61-0.95), and generalised epilepsy (AOR 4.17, CI: 1.37-12.70) were significant predictors for higher employability in PWE. Ability to work (education level), clinical factor (type of epilepsy) and psychological factor (self-determined motivation and family

Are pilot trials useful for predicting randomisation and attrition rates in definitive studies: A review of publicly funded trials

Science.gov (United States)

Whitehead, Amy; Pottrill, Edward; Julious, Steven A; Walters, Stephen J

2018-01-01

Background/aims: External pilot trials are recommended for testing the feasibility of main or confirmatory trials. However, there is little evidence that progress in external pilot trials actually predicts randomisation and attrition rates in the main trial. To assess the use of external pilot trials in trial design, we compared randomisation and attrition rates in publicly funded randomised controlled trials with rates in their pilots. Methods: Randomised controlled trials for which there was an external pilot trial were identified from reports published between 2004 and 2013 in the Health Technology Assessment Journal. Data were extracted from published papers, protocols and reports. Bland–Altman plots and descriptive statistics were used to investigate the agreement of randomisation and attrition rates between the full and external pilot trials. Results: Of 561 reports, 41 were randomised controlled trials with pilot trials and 16 met criteria for a pilot trial with sufficient data. Mean attrition and randomisation rates were 21.1% and 50.4%, respectively, in the pilot trials and 16.8% and 65.2% in the main. There was minimal bias in the pilot trial when predicting the main trial attrition and randomisation rate. However, the variation was large: the mean difference in the attrition rate between the pilot and main trial was −4.4% with limits of agreement of −37.1% to 28.2%. Limits of agreement for randomisation rates were −47.8% to 77.5%. Conclusion: Results from external pilot trials to estimate randomisation and attrition rates should be used with caution as comparison of the difference in the rates between pilots and their associated full trial demonstrates high variability. We suggest using internal pilot trials wherever appropriate. PMID:29361833

Functional remission and employment among patients with schizophrenia in Malaysia.

Science.gov (United States)

Dahlan, Rahima; Midin, Marhani; Shah, Shamsul Azhar; Nik Jaafar, Nik Ruzyanei; Abdul Rahman, Fairuz Nazri; Baharudin, Azlin; Das, Srijit; Sidi, Hatta

2014-01-01

The study aimed to determine the rates of functional remission and employment as well as the factors associated with functional remission among patients with Schizophrenia, receiving community psychiatric service in an urban setting in Malaysia. From a total of 250 patients randomly selected, 155 fulfilled the study requirement and were assessed on their functional remission status using the Personal and Social Performance Scale. The relationships between functional remission and socio-demographic factors, clinical factors, social support, symptom remission and rates of hospitalization were examined. The results revealed that 74% (n=115) of the respondents had functional remission with only 20% (n=31) currently employed. Functional remission was found to be significantly associated with good social support (84.4% versus 36.4% psocial support, lower hospitalization rate and symptom remission, as significant predictors of functional remission. A majority of patients with Schizophrenia in this study achieved functional remission, however, only a small percentage of them were employed. Functional remission was influenced by severity of illness and levels of social support in these patients. Copyright © 2014 Elsevier Inc. All rights reserved.

Exploring the handshake in employment interviews.

Science.gov (United States)

Stewart, Greg L; Dustin, Susan L; Barrick, Murray R; Darnold, Todd C

2008-09-01

The authors examined how an applicant's handshake influences hiring recommendations formed during the employment interview. A sample of 98 undergraduate students provided personality measures and participated in mock interviews during which the students received ratings of employment suitability. Five trained raters independently evaluated the quality of the handshake for each participant. Quality of handshake was related to interviewer hiring recommendations. Path analysis supported the handshake as mediating the effect of applicant extraversion on interviewer hiring recommendations, even after controlling for differences in candidate physical appearance and dress. Although women received lower ratings for the handshake, they did not on average receive lower assessments of employment suitability. Exploratory analysis suggested that the relationship between a firm handshake and interview ratings may be stronger for women than for men.

Employment status, employment functioning, and barriers to employment among VA primary care patients.

Science.gov (United States)

Zivin, Kara; Yosef, Matheos; Levine, Debra S; Abraham, Kristen M; Miller, Erin M; Henry, Jennifer; Nelson, C Beau; Pfeiffer, Paul N; Sripada, Rebecca K; Harrod, Molly; Valenstein, Marcia

2016-03-15

Prior research found lower employment rates among working-aged patients who use the VA than among non-Veterans or Veterans who do not use the VA, with the lowest reported employment rates among VA patients with mental disorders. This study assessed employment status, employment functioning, and barriers to employment among VA patients treated in primary care settings, and examined how depression and anxiety were associated with these outcomes. The sample included 287 VA patients treated in primary care in a large Midwestern VA Medical Center. Bivariate and multivariable analyses were conducted examining associations between socio-demographic and clinical predictors of six employment domains, including: employment status, job search self-efficacy, work performance, concerns about job loss among employed Veterans, and employment barriers and likelihood of job seeking among not employed Veterans. 54% of respondents were employed, 36% were not employed, and 10% were economically inactive. In adjusted analyses, participants with depression or anxiety (43%) were less likely to be employed, had lower job search self-efficacy, had lower levels of work performance, and reported more employment barriers. Depression and anxiety were not associated with perceived likelihood of job loss among employed or likelihood of job seeking among not employed. Single VA primary care clinic; cross-sectional study. Employment rates are low among working-aged VA primary care patients, particularly those with mental health conditions. Offering primary care interventions to patients that address mental health issues, job search self-efficacy, and work performance may be important in improving health, work, and economic outcomes. Published by Elsevier B.V.

Home treatment of COPD exacerbation selected by DECAF score: a non-inferiority, randomised controlled trial and economic evaluation.

Science.gov (United States)

Echevarria, Carlos; Gray, Joanne; Hartley, Tom; Steer, John; Miller, Jonathan; Simpson, A John; Gibson, G John; Bourke, Stephen C

2018-04-21

Previous models of Hospital at Home (HAH) for COPD exacerbation (ECOPD) were limited by the lack of a reliable prognostic score to guide patient selection. Approximately 50% of hospitalised patients have a low mortality risk by DECAF, thus are potentially suitable. In a non-inferiority randomised controlled trial, 118 patients admitted with a low-risk ECOPD (DECAF 0 or 1) were recruited to HAH or usual care (UC). The primary outcome was health and social costs at 90 days. Mean 90-day costs were £1016 lower in HAH, but the one-sided 95% CI crossed the non-inferiority limit of £150 (CI -2343 to 312). Savings were primarily due to reduced hospital bed days: HAH=1 (IQR 1-7), UC=5 (IQR 2-12) (P=0.001). Length of stay during the index admission in UC was only 3 days, which was 2 days shorter than expected. Based on quality-adjusted life years, the probability of HAH being cost-effective was 90%. There was one death within 90 days in each arm, readmission rates were similar and 90% of patients preferred HAH for subsequent ECOPD. HAH selected by low-risk DECAF score was safe, clinically effective, cost-effective, and preferred by most patients. Compared with earlier models, selection is simpler and approximately twice as many patients are eligible. The introduction of DECAF was associated with a fall in UC length of stay without adverse outcome, supporting use of DECAF to direct early discharge. Registered prospectively ISRCTN 29082260. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Evaluation of biases present in the cohort multiple randomised controlled trial design : a simulation study

NARCIS (Netherlands)

Candlish, Jane; Pate, Alexander; Sperrin, Matthew; Staa, Tjeerd P van

2017-01-01

BACKGROUND: The cohort multiple randomised controlled trial (cmRCT) design provides an opportunity to incorporate the benefits of randomisation within clinical practice; thus reducing costs, integrating electronic healthcare records, and improving external validity. This study aims to address a key

Healthcare costs in the Danish randomised controlled lung cancer CT-screening trial

DEFF Research Database (Denmark)

Rasmussen, J.F.; Siersma, V.; Pedersen, Jesper H.

2014-01-01

: This registry study was nested in a randomised controlled trial (DLCST). 4104 participants, current or former heavy smokers, aged 50-70 years were randomised to five annual low dose CT scans or usual care during 2004-2010. Total healthcare costs and healthcare utilisation data for both the primary...... and the secondary healthcare sector were retrieved from public registries from randomisation - September 2011 and compared between (1) the CT-screening group and the control group and, (2) the control group and each of the true-positive, false-positive and true-negative groups. RESULTS: The median annual costs per...... participant were significantly higher in the CT-screening group (Euros [EUR] 1342, interquartile range [IQR] 750-2980) compared with the control group (EUR 1190, IQR 590-2692) (pcost of the CT-screening programme was excluded, there was no longer a statistically significant difference...

Concurrent validation of a neurocognitive assessment protocol for clients with mental illness in job matching as shop sales in supported employment.

Science.gov (United States)

Ng, S S W; Lak, D C C; Lee, S C K; Ng, P P K

2015-03-01

Occupational therapists play a major role in the assessment and referral of clients with severe mental illness for supported employment. Nonetheless, there is scarce literature about the content and predictive validity of the process. In addition, the criteria of successful job matching have not been analysed and job supervisors have relied on experience rather than objective standards in recruitment. This study aimed to explore the profile of successful clients working in 'shop sales' in a supportive environment using a neurocognitive assessment protocol, and to validate the protocol against 'internal standards' of the job supervisors. This was a concurrent validation study of criterion-related scales for a single job type. The subjective ratings from the supervisors were concurrently validated against the results of neurocognitive assessment of intellectual function and work-related cognitive behaviour. A regression model was established for clients who succeeded and failed in employment using supervisor's ratings and a cutoff value of 10.5 for the Performance Fitness Rating Scale (R(2) = 0.918, F[41] = 3.794, p = 0.003). Classification And Regression Tree was also plotted to identify the profile of cases, with an overall accuracy of 0.861 (relative error, 0.26). Use of both inference statistics and data mining techniques enables the decision tree of neurocognitive assessments to be more readily applied by therapists in vocational rehabilitation, and thus directly improve the efficiency and efficacy of the process.

Evaluation of a smartphone nutrition and physical activity application to provide lifestyle advice to pregnant women: The SNAPP randomised trial.

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Dodd, Jodie M; Louise, Jennie; Cramp, Courtney; Grivell, Rosalie M; Moran, Lisa J; Deussen, Andrea R

2018-01-01

Our objective was to evaluate the impact of a smartphone application as an adjunct to face-to-face consultations in facilitating dietary and physical activity change among pregnant women. This multicentre, nested randomised trial involved pregnant women with a body mass index ≥18.5 kg/m 2 , with a singleton pregnancy between 10 and 20 weeks' gestation, and participating in 2 pregnancy nutrition-based randomised trials across metropolitan Adelaide, South Australia. All women participating in the SNAPP trial received a comprehensive dietary, physical activity, and behavioural intervention, as part of the GRoW or OPTIMISE randomised trials. Women were subsequently randomised to either the "Lifestyle Advice Only Group," where women received the above intervention, or the "Lifestyle Advice plus Smartphone Application Group," where women were additionally provided access to the smartphone application. The primary outcome was healthy eating index (HEI) assessed by maternal food frequency questionnaire completed at trial entry, and 28 and 36 weeks' gestation. Analyses were performed using intention-to-treat principles, with statistical significance at p = .05. One hundred sixty-two women participated: 77 allocated to the Lifestyle Advice plus Smartphone Application Group and 85 to the Lifestyle Advice Only Group. Mean difference in HEI score at 28 weeks of pregnancy was 0.01 (CI [-2.29, 2.62]) and at 36 weeks of pregnancy -1.16 (CI [-4.60, 2.28]). There was no significant additional benefit from the provision of the smartphone application in improving HEI score (p = .452). Although all women improved dietary quality across pregnancy, use of the smartphone application was poor. Our findings do not support addition of the smartphone application. © 2017 John Wiley & Sons Ltd.

Methods of weaning preterm babies CPAP: a multicentre randomised controlled trial.

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Todd, David A; Wright, A; Broom, M; Chauhan, M; Meskell, S; Cameron, C; Perdomi, A M; Rochefort, M; Jardine, L; Stewart, A; Shadbolt, B

2012-07-01

Controversy exists whether different continuous positive airway pressure (CPAP) weaning methods influence time to wean off CPAP, CPAP duration, oxygen duration, Bronchopulmonary Dysplasia (BPD) or length of admission. In a multicentre randomised controlled trial, the authors have primarily compared CPAP weaning methods impact on time to wean off CPAP and CPAP duration and secondarily their effect on oxygen duration, BPD and time of admission. Between April 2006 and October 2009, 177 infants CPAP were randomised to one of the three CPAP weaning methods (M). M1: Taken 'OFF' CPAP with the view to stay 'OFF'. M2: Cycled on and off CPAP with incremental time 'OFF'. M3: As with m(2), cycled on and off CPAP but during 'OFF' periods were supported by 2 mm nasal cannula at a flow of 0.5 l/min. Based on intention to treat analysis, there was no significant difference in mean GA or birthweight between the groups (27.1 ± 1.4, 26.9 ± 1.6 and 27.3 ± 1.5 (weeks ± 1SD) and 988 ± 247, 987 ± 249 and 1015 ± 257 (grams ± 1SD), respectively). Primary outcomes showed M1 produced a significantly shorter time to wean from CPAP (11.3 ± 0.8, 16.8 ± 1.0, 19.4 ± 1.3 (days ± 1SE) pCPAP duration (24.4 ± 0.1, 38.6 ± 0.1, 30.5 ± 0.1 (days ± 1SE) pCPAP weaning time, CPAP duration, oxygen duration, BPD and admission time.

How many workers are employed in California agriculture?

Directory of Open Access Journals (Sweden)

Philip Martin

2016-08-01

Full Text Available In 2014, the average employment of hired workers in California crop and livestock agriculture, counting all occupations, rose by 10% to 410,900. However, although the state reports the number of jobs on farms regularly, it does not report the number of workers who fill these jobs. We analyzed all Social Security numbers reported by farm employers in 2014 and found two workers for each average or year-round equivalent farm job, making the total number of farmworkers employed in agriculture 829,300, or twice average employment. Approximately 83% of farmworkers had their maximum earnings with an agricultural employer in 2014, and almost 80% of those primary farmworkers were employed by crop support firms (392,000 or fruit and nut farms (154,000. Over 60% of all workers had only one farm employer, followed by 27% with two or more farm employers, and 35% were employed in Kern (116,000, Fresno (96,000 and Monterey (82,000 counties. These data show that California has a remarkably stable farm workforce: most farmworkers are attached to one farm employer, often a labor contractor who moves them from farm to farm.

Workplace breastfeeding support for hospital employees.

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Dodgson, Joan E; Chee, Yuet-Oi; Yap, Tian Sew

2004-07-01

Breastfeeding initiation rates have been steadily rising in Hong Kong, but most employed women wean prior to returning to work. While health care providers promote breastfeeding, women receive little support from employers. A few health care facilities offer some workplace breastfeeding support, but little is known about the specific types and amount of support that are offered. This paper reports a study whose aim was to describe workplace supports available to breastfeeding women employed by hospitals that provide maternity services in Hong Kong, and to determine if differences in workplace supports exist based on the hospitals' numbers of employees or funding source. In late 2001, a cross-sectional survey was completed by nurse managers or lactation consultants most knowledgeable about supports to breastfeeding employees in 19 hospitals. The number of workplace breastfeeding supports or Breastfeeding Support Score (M = 7.47; sd = 3.37) varied considerably. Mean Breastfeeding Support Score for government-funded hospitals was significantly higher (t = 2.31; P = 0.03) than for private hospitals. Of the 14 hospitals that had a designated space for using a breast pump, only five (26.3%) had a private room with a door that locked. Only two hospitals (11.1%) allowed employees to take breaks as needed to use a pump; employees in 10 (55.6%) had to use their meal and regular break times. Hospitals having a hospital-wide committee that addressed workplace breastfeeding issues had a more supportive environment for breastfeeding employees. Although all surveyed hospitals returned the questionnaire, the sample size was small. It was difficult to ensure accuracy and to differentiate subtle variations in the services provided using a self-report survey. Facilitating continued breastfeeding after employees' return to work requires that employers understand the needs of breastfeeding employees. Policy at the level of the employer and government is an essential component of

EXTUBATE: A randomised controlled trial of nasal biphasic positive airway pressure vs. nasal continuous positive airway pressure following extubation in infants less than 30 weeks' gestation: study protocol for a randomised controlled trial

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Victor Suresh

2011-12-01

Full Text Available Abstract Background Respiratory distress syndrome remains a significant problem among premature infants. Mechanical ventilation through an endotracheal tube remains the mainstay of respiratory support but may be associated with lung injury and the development of chronic lung disease of prematurity. Efforts are needed to reduce the duration of mechanical ventilation in favour of less invasive forms of respiratory support and to improve rates of successful extubation. Non-invasive respiratory support has been demonstrated to be less injurious to the premature lung. Standard practice is to use nasal continuous positive airway pressure (n-CPAP following extubation to support the baby's breathing. Many clinicians also use nasal biphasic positive airway pressure (n-BiPAP in efforts to improve rates of successful extubation. However, there is currently no evidence that this confers any advantage over conventional nasal continuous positive airway pressure. Methods We propose an unblinded multi-centre randomised trial comparing n-CPAP with n-BiPAP in babies born before 30 weeks' gestation and less than two weeks old. Babies with congenital abnormalities and severe intra-ventricular haemorrhage will be excluded. 540 babies admitted to neonatal centres in England will be randomised at the time of first extubation attempt. The primary aim of this study is to compare the rate of extubation failure within 48 hours following the first attempt at extubation. The secondary aims are to compare the effect of n-BiPAP and n-CPAP on the following outcomes: 1. Maintenance of successful extubation for 7 days post extubation 2. Oxygen requirement at 28 days of age and at 36 weeks' corrected gestational age 3. Total days on ventilator, n-CPAP/n-BiPAP 4. Number of ventilator days following first extubation attempt 5. pH and partial pressure of carbon dioxide in the first post extubation blood gas 6. Duration of hospital stay 7. Rate of abdominal distension requiring

Soldiers’ employment attitude and employability: An exploratory study

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Peng Gao

2015-04-01

Full Text Available Purpose: Nowadays it is very difficult for Chinese retired soldiers to find proper jobs, and the primary reason is the significant gap between job requirements and soldiers owned job skills. Therefore, it is very important to improve the soldiers’ job skills and enhance their understanding of employment.Design/methodology/approach: This paper expands the study scope from the soldiers’ job skills to the employability, initiatively introduces the employment attitude which has obvious impact on the employment of soldiers, and analyses the influence that employment attitude can play on employability. At last, this paper develops statistical method to find the relationship between soldiers’ employment attitude and employability.Findings: The empirical analysis shows that soldiers’ employment attitude has the positive linkage with employability, which makes the employment attitude a measurable variable for the employability rather than an absolute standard.Research limitations/implications: According to the research purpose, more variables should be considered in the model, consequently, there are only three indicators to describe solders’ employment attitude and four indicators to describe solders’ employability.Originality/value: This paper takes research on soldiers’ employability in a new perspective. The soldiers’ employment attitude is served as the entry point, showing the influence that soldiers’ employment attitude has on employability.

a randomised controlled trial oftwo prostaglandin regitnens

African Journals Online (AJOL)

Design. A prospective randomised controlled trial. Setting. Department of Obstetrics and Gynae- ... hours after the original administration of either prostaglandin regimen. If abortion had not taken place 36 .... Tygerberg Hospital for permission to publish, and Upjohn. (Pry) Ltd for supplying the Prepidil gel used in the study. 1.

The Job Accommodation Scale (JAS): Psychometric evaluation of a new measure of employer support for temporary job modifications

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Shaw, William S.; Kristman, Vicki L.; Williams-Whitt, Kelly; Soklaridis, Sophie; Huang, Yueng-Hsiang; Côté, Pierre; Loisel, Patrick

2015-01-01

INTRODUCTION An employer offer of temporary job modification is a key strategy for facilitating return-to-work (RTW) for musculoskeletal conditions, but there are no validated scales to assess the level of support for temporary job modifications across a range of job types and organizations. OBJECTIVE To pilot test a new 21-item self-report measure (the Job Accommodation Scale [JAS]) to assess its applicability, internal consistency, factor structure, and relation to physical job demands. METHODS Supervisors (N = 804, 72.8% male, mean age = 46) were recruited from 19 employment settings in the USA and Canada and completed a 30-min online survey regarding job modification practices. As part of the survey, supervisors nominated and described a job position they supervised and completed the JAS for a hypothetical worker (in that position) with an episode of low back pain. Job characteristics were derived from the occupational informational network job classification database. RESULTS The full response range (1–4) was utilized on all 21 items, with no ceiling or floor effects. Avoiding awkward postures was the most feasible accommodation and moving the employee to a different site or location was the least feasible. An exploratory factor analysis suggested five underlying factors (Modify physical workload; Modify work environment; Modify work schedule; Find alternate work; and Arrange for assistance), and there was an acceptable goodness-of-fit for the five parceled sub-factor scores as a single latent construct in a measurement model (structural equation model). Job accommodations were less feasible for more physical jobs and for heavier industries. CONCLUSIONS The pilot administration of the JAS with respect to a hypothetical worker with LBP showed initial support for its applicability, reliability, and validity when administered to supervisors. Future studies should assess its validity for use in actual disability cases, for a range of health conditions, and to

Effect of Consuming Tea with Stevia on Salivary pH - An In Vivo Randomised Controlled Trial.

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Pallepati, Akhil; Yavagal, Puja; Veeresh, D J

To assess the effect of consuming tea with stevia on salivary pH. This randomised controlled trial employed a Latin square design. Twenty-four male students aged 20-23 years were randomly allocated to 4 different groups, 3 experimental with tea sweetened by sucrose, jaggery or stevia, and one unsweetened control. Salivary pH assessments were performed at baseline and 1 min, 20 and 60 min after consumption of the respective tea. One-way ANOVA and repeated measures ANOVA followed by Tukey's post-hoc tests were employed to analyse the data. One minute after tea consumption, the salivary pH of the sucrose group significantly decreased compared to the stevia group (p = 0.01). There was a significant difference between baseline mean salivary pH and post-interventional mean salivary pH values at all time intervals in the tea + sucrose, tea + jaggery, and plain tea groups (p stevia and plain tea groups, but it remained lower in the sucrose and jaggery groups. The results of the present study, in which the salivary pH values returned to baseline pH 1 h after drinking stevia-sweetened tea, suggest stevia's potential as a non-cariogenic sweetener.

Effect of a participatory ergonomics intervention on psychosocial factors at work in a randomised controlled trial.

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Haukka, Eija; Pehkonen, Irmeli; Leino-Arjas, Päivi; Viikari-Juntura, Eira; Takala, Esa-Pekka; Malmivaara, Antti; Hopsu, Leila; Mutanen, Pertti; Ketola, Ritva; Virtanen, Tuija; Holtari-Leino, Merja; Nykänen, Jaana; Stenholm, Sari; Ojajärvi, Anneli; Riihimäki, Hilkka

2010-03-01

To study the effect of a participatory ergonomics intervention on psychosocial factors among kitchen workers. A cluster randomised controlled trial. Four cities in Finland, 2002-2005. 504 workers in 119 municipal kitchens. Kitchens were randomised to intervention (n=59) and control (n=60) groups. The intervention lasted 11-14 months and was based on the workers' active participation in work analysis, planning and implementing the ergonomic changes aimed at decreasing the physical and mental workload. Mental stress, mental strenuousness of work, hurry, job satisfaction, job control, skill discretion, co-worker relationships and supervisor support. Data were collected by questionnaire at baseline, at the end of the intervention, and at a 12-month follow-up (PI(12)). At the end of the intervention, the OR of job dissatisfaction for the intervention group as compared with the control group was 3.0 (95% CI 1.1 to 8.5), of mental stress 2.3 (1.2 to 4.7) and of poor co-worker relationships 2.3 (1.0 to 5.2). At the PI(12), the OR of job dissatisfaction was 3.0 (1.2 to 7.8). Analysis of the independent and joint effects of the intervention and unconnected organisational reforms showed that adverse changes were accentuated among those with exposure to both. No favourable effects on psychosocial factors at work were found. The adverse changes were due to a joint effect of the intervention and the unconnected organisational reforms. The findings do not support the usefulness of this kind of intervention in changing unsatisfactory psychosocial working conditions.

Vitamin D and risk of pregnancy related hypertensive disorders: mendelian randomisation study.

Science.gov (United States)

Magnus, Maria C; Miliku, Kozeta; Bauer, Anna; Engel, Stephanie M; Felix, Janine F; Jaddoe, Vincent W V; Lawlor, Debbie A; London, Stephanie J; Magnus, Per; McGinnis, Ralph; Nystad, Wenche; Page, Christian M; Rivadeneira, Fernando; Stene, Lars C; Tapia, German; Williams, Nicholas; Bonilla, Carolina; Fraser, Abigail

2018-06-20

To use mendelian randomisation to investigate whether 25-hydroxyvitamin D concentration has a causal effect on gestational hypertension or pre-eclampsia. One and two sample mendelian randomisation analyses. Two European pregnancy cohorts (Avon Longitudinal Study of Parents and Children, and Generation R Study), and two case-control studies (subgroup nested within the Norwegian Mother and Child Cohort Study, and the UK Genetics of Pre-eclampsia Study). 7389 women in a one sample mendelian randomisation analysis (751 with gestational hypertension and 135 with pre-eclampsia), and 3388 pre-eclampsia cases and 6059 controls in a two sample mendelian randomisation analysis. Single nucleotide polymorphisms in genes associated with vitamin D synthesis (rs10741657 and rs12785878) and metabolism (rs6013897 and rs2282679) were used as instrumental variables. Gestational hypertension and pre-eclampsia defined according to the International Society for the Study of Hypertension in Pregnancy. In the conventional multivariable analysis, the relative risk for pre-eclampsia was 1.03 (95% confidence interval 1.00 to 1.07) per 10% decrease in 25-hydroxyvitamin D level, and 2.04 (1.02 to 4.07) for 25-hydroxyvitamin D levels effect of 25-hydroxyvitamin D on the risk of gestational hypertension or pre-eclampsia: odds ratio 0.90 (95% confidence interval 0.78 to 1.03) and 1.19 (0.92 to 1.52) per 10% decrease, respectively. The two sample mendelian randomisation estimate gave an odds ratio for pre-eclampsia of 0.98 (0.89 to 1.07) per 10% decrease in 25-hydroxyvitamin D level, an odds ratio of 0.96 (0.80 to 1.15) per unit increase in the log(odds) of 25-hydroxyvitamin D level effect of vitamin D status on gestational hypertension or pre-eclampsia. Future mendelian randomisation studies with a larger number of women with pre-eclampsia or more genetic instruments that would increase the proportion of 25-hydroxyvitamin D levels explained by the instrument are needed. Published by the BMJ

Reporting non-adherence in cluster randomised trials: A systematic review.

Science.gov (United States)

Agbla, Schadrac C; DiazOrdaz, Karla

2018-06-01

Treatment non-adherence in randomised trials refers to situations where some participants do not receive their allocated treatment as intended. For cluster randomised trials, where the unit of randomisation is a group of participants, non-adherence may occur at the cluster or individual level. When non-adherence occurs, randomisation no longer guarantees that the relationship between treatment receipt and outcome is unconfounded, and the power to detect the treatment effects in intention-to-treat analysis may be reduced. Thus, recording adherence and estimating the causal treatment effect adequately are of interest for clinical trials. To assess the extent of reporting of non-adherence issues in published cluster trials and to establish which methods are currently being used for addressing non-adherence, if any, and whether clustering is accounted for in these. We systematically reviewed 132 cluster trials published in English in 2011 previously identified through a search in PubMed. One-hundred and twenty three cluster trials were included in this systematic review. Non-adherence was reported in 56 cluster trials. Among these, 19 reported a treatment efficacy estimate: per protocol in 15 and as treated in 4. No study discussed the assumptions made by these methods, their plausibility or the sensitivity of the results to deviations from these assumptions. The year of publication of the cluster trials included in this review (2011) could be considered a limitation of this study; however, no new guidelines regarding the reporting and the handling of non-adherence for cluster trials have been published since. In addition, a single reviewer undertook the data extraction. To mitigate this, a second reviewer conducted a validation of the extraction process on 15 randomly selected reports. Agreement was satisfactory (93%). Despite the recommendations of the Consolidated Standards of Reporting Trials statement extension to cluster randomised trials, treatment adherence is

Initiating change locally in bullying and aggression through the school environment (INCLUSIVE): study protocol for a cluster randomised controlled trial.

Science.gov (United States)

Bonell, Chris; Allen, Elizabeth; Christie, Deborah; Elbourne, Diana; Fletcher, Adam; Grieve, Richard; LeGood, Rosa; Mathiot, Anne; Scott, Stephen; Wiggins, Meg; Viner, Russell M

2014-09-30

Systematic reviews suggest that interventions that address school organisation are effective in reducing victimisation and bullying. We successfully piloted a school environment intervention modified from international studies to incorporate 'restorative justice' approaches. This trial aims to establish the effectiveness and cost-effectiveness of the INCLUSIVE intervention in reducing aggression and bullying in English secondary schools. cluster randomised trial. 40 state-supported secondary schools. OUTCOMES assessed among the cohort of students in year 8 (n = approximately 6,000) in intervention year 1. INCLUSIVE is a school-led intervention which combines changes to the school environment with the promotion of social and emotional skills and restorative practices through: the formation of a school action group involving students and staff supported by an external facilitator to review local data on needs, determine priorities, and develop and implement an action plan for revising relevant school policies/rules and other actions to improve relationships at school and reduce aggression; staff training in restorative practices; and a new social and emotional skills curriculum. The intervention will be delivered by schools supported in the first two years by educational facilitators independent of the research team, with a third locally facilitated intervention year.Comparator: normal practice. primary: 2 primary outcomes at student level assessed at baseline and at 36 months:1. Aggressive behaviours in school: Edinburgh Study of Youth Transitions and Crime school misbehaviour subscale (ESYTC)2. Bullying and victimisation: Gatehouse Bullying Scale (GBS)Secondary outcomes assessed at baseline, 24 and 36 months will include measures relating to the economic evaluation, psychosocial outcomes in students and staff and school-level truancy and exclusion rates. 20 schools per arm will provide 90% power to identify an effect size of 0.25 SD with a 5% significance level.Randomisation