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Sample records for step-wedge cluster-randomised community-based

  1. Group sequential designs for stepped-wedge cluster randomised trials.

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    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

  2. A structural multidisciplinary approach to depression management in nursing-home residents: a multicentre, stepped-wedge cluster-randomised trial

    NARCIS (Netherlands)

    Leontjevas, R.; Gerritsen, D.L.; Smalbrugge, M.; Teerenstra, S.; Vernooij-Dassen, M.J.F.J.; Koopmans, R.T.C.M.

    2013-01-01

    BACKGROUND: Depression in nursing-home residents is often under-recognised. We aimed to establish the effectiveness of a structural approach to its management. METHODS: Between May 15, 2009, and April 30, 2011, we undertook a multicentre, stepped-wedge cluster-randomised trial in four provinces of

  3. Stepped-wedge cluster randomised controlled trials: a generic framework including parallel and multiple-level designs.

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    Hemming, Karla; Lilford, Richard; Girling, Alan J

    2015-01-30

    Stepped-wedge cluster randomised trials (SW-CRTs) are being used with increasing frequency in health service evaluation. Conventionally, these studies are cross-sectional in design with equally spaced steps, with an equal number of clusters randomised at each step and data collected at each and every step. Here we introduce several variations on this design and consider implications for power. One modification we consider is the incomplete cross-sectional SW-CRT, where the number of clusters varies at each step or where at some steps, for example, implementation or transition periods, data are not collected. We show that the parallel CRT with staggered but balanced randomisation can be considered a special case of the incomplete SW-CRT. As too can the parallel CRT with baseline measures. And we extend these designs to allow for multiple layers of clustering, for example, wards within a hospital. Building on results for complete designs, power and detectable difference are derived using a Wald test and obtaining the variance-covariance matrix of the treatment effect assuming a generalised linear mixed model. These variations are illustrated by several real examples. We recommend that whilst the impact of transition periods on power is likely to be small, where they are a feature of the design they should be incorporated. We also show examples in which the power of a SW-CRT increases as the intra-cluster correlation (ICC) increases and demonstrate that the impact of the ICC is likely to be smaller in a SW-CRT compared with a parallel CRT, especially where there are multiple levels of clustering. Finally, through this unified framework, the efficiency of the SW-CRT and the parallel CRT can be compared. © 2014 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

  4. Unequal cluster sizes in stepped-wedge cluster randomised trials: a systematic review.

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    Kristunas, Caroline; Morris, Tom; Gray, Laura

    2017-11-15

    To investigate the extent to which cluster sizes vary in stepped-wedge cluster randomised trials (SW-CRT) and whether any variability is accounted for during the sample size calculation and analysis of these trials. Any, not limited to healthcare settings. Any taking part in an SW-CRT published up to March 2016. The primary outcome is the variability in cluster sizes, measured by the coefficient of variation (CV) in cluster size. Secondary outcomes include the difference between the cluster sizes assumed during the sample size calculation and those observed during the trial, any reported variability in cluster sizes and whether the methods of sample size calculation and methods of analysis accounted for any variability in cluster sizes. Of the 101 included SW-CRTs, 48% mentioned that the included clusters were known to vary in size, yet only 13% of these accounted for this during the calculation of the sample size. However, 69% of the trials did use a method of analysis appropriate for when clusters vary in size. Full trial reports were available for 53 trials. The CV was calculated for 23 of these: the median CV was 0.41 (IQR: 0.22-0.52). Actual cluster sizes could be compared with those assumed during the sample size calculation for 14 (26%) of the trial reports; the cluster sizes were between 29% and 480% of that which had been assumed. Cluster sizes often vary in SW-CRTs. Reporting of SW-CRTs also remains suboptimal. The effect of unequal cluster sizes on the statistical power of SW-CRTs needs further exploration and methods appropriate to studies with unequal cluster sizes need to be employed. © 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.

  5. Effects of a free school breakfast programme on school attendance, achievement, psychosocial function, and nutrition: a stepped wedge cluster randomised trial.

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    Ni Mhurchu, Cliona; Turley, Maria; Gorton, Delvina; Jiang, Yannan; Michie, Jo; Maddison, Ralph; Hattie, John

    2010-11-29

    Approximately 55,000 children in New Zealand do not eat breakfast on any given day. Regular breakfast skipping has been associated with poor diets, higher body mass index, and adverse effects on children's behaviour and academic performance. Research suggests that regular breakfast consumption can improve academic performance, nutrition and behaviour. This paper describes the protocol for a stepped wedge cluster randomised trial of a free school breakfast programme. The aim of the trial is to determine the effects of the breakfast intervention on school attendance, achievement, psychosocial function, dietary habits and food security. Sixteen primary schools in the North Island of New Zealand will be randomised in a sequential stepped wedge design to a free before-school breakfast programme consisting of non-sugar coated breakfast cereal, milk products, and/or toast and spreads. Four hundred children aged 5-13 years (approximately 25 per school) will be recruited. Data collection will be undertaken once each school term over the 2010 school year (February to December). The primary trial outcome is school attendance, defined as the proportion of students achieving an attendance rate of 95% or higher. Secondary outcomes are academic achievement (literacy, numeracy, self-reported grades), sense of belonging at school, psychosocial function, dietary habits, and food security. A concurrent process evaluation seeks information on parents', schools' and providers' perspectives of the breakfast programme. This randomised controlled trial will provide robust evidence of the effects of a school breakfast programme on students' attendance, achievement and nutrition. Furthermore the study provides an excellent example of the feasibility and value of the stepped wedge trial design in evaluating pragmatic public health intervention programmes. Australian New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12609000854235.

  6. Effects of a free school breakfast programme on school attendance, achievement, psychosocial function, and nutrition: a stepped wedge cluster randomised trial

    Directory of Open Access Journals (Sweden)

    Maddison Ralph

    2010-11-01

    Full Text Available Abstract Background Approximately 55,000 children in New Zealand do not eat breakfast on any given day. Regular breakfast skipping has been associated with poor diets, higher body mass index, and adverse effects on children's behaviour and academic performance. Research suggests that regular breakfast consumption can improve academic performance, nutrition and behaviour. This paper describes the protocol for a stepped wedge cluster randomised trial of a free school breakfast programme. The aim of the trial is to determine the effects of the breakfast intervention on school attendance, achievement, psychosocial function, dietary habits and food security. Methods/Design Sixteen primary schools in the North Island of New Zealand will be randomised in a sequential stepped wedge design to a free before-school breakfast programme consisting of non-sugar coated breakfast cereal, milk products, and/or toast and spreads. Four hundred children aged 5-13 years (approximately 25 per school will be recruited. Data collection will be undertaken once each school term over the 2010 school year (February to December. The primary trial outcome is school attendance, defined as the proportion of students achieving an attendance rate of 95% or higher. Secondary outcomes are academic achievement (literacy, numeracy, self-reported grades, sense of belonging at school, psychosocial function, dietary habits, and food security. A concurrent process evaluation seeks information on parents', schools' and providers' perspectives of the breakfast programme. Discussion This randomised controlled trial will provide robust evidence of the effects of a school breakfast programme on students' attendance, achievement and nutrition. Furthermore the study provides an excellent example of the feasibility and value of the stepped wedge trial design in evaluating pragmatic public health intervention programmes. Trial Registration Number Australian New Zealand Clinical Trials Registry

  7. An imbalance in cluster sizes does not lead to notable loss of power in cross-sectional, stepped-wedge cluster randomised trials with a continuous outcome.

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    Kristunas, Caroline A; Smith, Karen L; Gray, Laura J

    2017-03-07

    The current methodology for sample size calculations for stepped-wedge cluster randomised trials (SW-CRTs) is based on the assumption of equal cluster sizes. However, as is often the case in cluster randomised trials (CRTs), the clusters in SW-CRTs are likely to vary in size, which in other designs of CRT leads to a reduction in power. The effect of an imbalance in cluster size on the power of SW-CRTs has not previously been reported, nor what an appropriate adjustment to the sample size calculation should be to allow for any imbalance. We aimed to assess the impact of an imbalance in cluster size on the power of a cross-sectional SW-CRT and recommend a method for calculating the sample size of a SW-CRT when there is an imbalance in cluster size. The effect of varying degrees of imbalance in cluster size on the power of SW-CRTs was investigated using simulations. The sample size was calculated using both the standard method and two proposed adjusted design effects (DEs), based on those suggested for CRTs with unequal cluster sizes. The data were analysed using generalised estimating equations with an exchangeable correlation matrix and robust standard errors. An imbalance in cluster size was not found to have a notable effect on the power of SW-CRTs. The two proposed adjusted DEs resulted in trials that were generally considerably over-powered. We recommend that the standard method of sample size calculation for SW-CRTs be used, provided that the assumptions of the method hold. However, it would be beneficial to investigate, through simulation, what effect the maximum likely amount of inequality in cluster sizes would be on the power of the trial and whether any inflation of the sample size would be required.

  8. The optimal design of stepped wedge trials with equal allocation to sequences and a comparison to other trial designs.

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    Thompson, Jennifer A; Fielding, Katherine; Hargreaves, James; Copas, Andrew

    2017-12-01

    Background/Aims We sought to optimise the design of stepped wedge trials with an equal allocation of clusters to sequences and explored sample size comparisons with alternative trial designs. Methods We developed a new expression for the design effect for a stepped wedge trial, assuming that observations are equally correlated within clusters and an equal number of observations in each period between sequences switching to the intervention. We minimised the design effect with respect to (1) the fraction of observations before the first and after the final sequence switches (the periods with all clusters in the control or intervention condition, respectively) and (2) the number of sequences. We compared the design effect of this optimised stepped wedge trial to the design effects of a parallel cluster-randomised trial, a cluster-randomised trial with baseline observations, and a hybrid trial design (a mixture of cluster-randomised trial and stepped wedge trial) with the same total cluster size for all designs. Results We found that a stepped wedge trial with an equal allocation to sequences is optimised by obtaining all observations after the first sequence switches and before the final sequence switches to the intervention; this means that the first sequence remains in the control condition and the last sequence remains in the intervention condition for the duration of the trial. With this design, the optimal number of sequences is [Formula: see text], where [Formula: see text] is the cluster-mean correlation, [Formula: see text] is the intracluster correlation coefficient, and m is the total cluster size. The optimal number of sequences is small when the intracluster correlation coefficient and cluster size are small and large when the intracluster correlation coefficient or cluster size is large. A cluster-randomised trial remains more efficient than the optimised stepped wedge trial when the intracluster correlation coefficient or cluster size is small. A

  9. Neoadjuvant chemoradiotherapy plus surgery versus active surveillance for oesophageal cancer: a stepped-wedge cluster randomised trial.

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    Noordman, Bo Jan; Wijnhoven, Bas P L; Lagarde, Sjoerd M; Boonstra, Jurjen J; Coene, Peter Paul L O; Dekker, Jan Willem T; Doukas, Michael; van der Gaast, Ate; Heisterkamp, Joos; Kouwenhoven, Ewout A; Nieuwenhuijzen, Grard A P; Pierie, Jean-Pierre E N; Rosman, Camiel; van Sandick, Johanna W; van der Sangen, Maurice J C; Sosef, Meindert N; Spaander, Manon C W; Valkema, Roelf; van der Zaag, Edwin S; Steyerberg, Ewout W; van Lanschot, J Jan B

    2018-02-06

    Neoadjuvant chemoradiotherapy (nCRT) plus surgery is a standard treatment for locally advanced oesophageal cancer. With this treatment, 29% of patients have a pathologically complete response in the resection specimen. This provides the rationale for investigating an active surveillance approach. The aim of this study is to assess the (cost-)effectiveness of active surveillance vs. standard oesophagectomy after nCRT for oesophageal cancer. This is a phase-III multi-centre, stepped-wedge cluster randomised controlled trial. A total of 300 patients with clinically complete response (cCR, i.e. no local or disseminated disease proven by histology) after nCRT will be randomised to show non-inferiority of active surveillance to standard oesophagectomy (non-inferiority margin 15%, intra-correlation coefficient 0.02, power 80%, 2-sided α 0.05, 12% drop-out). Patients will undergo a first clinical response evaluation (CRE-I) 4-6 weeks after nCRT, consisting of endoscopy with bite-on-bite biopsies of the primary tumour site and other suspected lesions. Clinically complete responders will undergo a second CRE (CRE-II), 6-8 weeks after CRE-I. CRE-II will include 18F-FDG-PET-CT, followed by endoscopy with bite-on-bite biopsies and ultra-endosonography plus fine needle aspiration of suspected lymph nodes and/or PET- positive lesions. Patients with cCR at CRE-II will be assigned to oesophagectomy (first phase) or active surveillance (second phase of the study). The duration of the first phase is determined randomly over the 12 centres, i.e., stepped-wedge cluster design. Patients in the active surveillance arm will undergo diagnostic evaluations similar to CRE-II at 6/9/12/16/20/24/30/36/48 and 60 months after nCRT. In this arm, oesophagectomy will be offered only to patients in whom locoregional regrowth is highly suspected or proven, without distant dissemination. The main study parameter is overall survival; secondary endpoints include percentage of patients who do not

  10. Improving oxygen therapy for children and neonates in secondary hospitals in Nigeria: study protocol for a stepped-wedge cluster randomised trial.

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    Graham, Hamish R; Ayede, Adejumoke I; Bakare, Ayobami A; Oyewole, Oladapo B; Peel, David; Gray, Amy; McPake, Barbara; Neal, Eleanor; Qazi, Shamim; Izadnegahdar, Rasa; Falade, Adegoke G; Duke, Trevor

    2017-10-27

    Oxygen is a life-saving, essential medicine that is important for the treatment of many common childhood conditions. Improved oxygen systems can reduce childhood pneumonia mortality substantially. However, providing oxygen to children is challenging, especially in small hospitals with weak infrastructure and low human resource capacity. This trial will evaluate the implementation of improved oxygen systems at secondary-level hospitals in southwest Nigeria. The improved oxygen system includes: a standardised equipment package; training of clinical and technical staff; infrastructure support (including improved power supply); and quality improvement activities such as supportive supervision. Phase 1 will involve the introduction of pulse oximetry alone; phase 2 will involve the introduction of the full, improved oxygen system package. We have based the intervention design on a theory-based analysis of previous oxygen projects, and used quality improvement principles, evidence-based teaching methods, and behaviour-change strategies. We are using a stepped-wedge cluster randomised design with participating hospitals randomised to receive an improved oxygen system at 4-month steps (three hospitals per step). Our mixed-methods evaluation will evaluate effectiveness, impact, sustainability, process and fidelity. Our primary outcome measures are childhood pneumonia case fatality rate and inpatient neonatal mortality rate. Secondary outcome measures include a range of clinical, quality of care, technical, and health systems outcomes. The planned study duration is from 2015 to 2018. Our study will provide quality evidence on the effectiveness of improved oxygen systems, and how to better implement and scale-up oxygen systems in resource-limited settings. Our results should have important implications for policy-makers, hospital administrators, and child health organisations in Africa and globally. Australian New Zealand Clinical Trials Registry: ACTRN12617000341325

  11. 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

  12. The Feedback Intervention Trial (FIT) — Improving Hand-Hygiene Compliance in UK Healthcare Workers: A Stepped Wedge Cluster Randomised Controlled Trial

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    Fuller, Christopher; Michie, Susan; Savage, Joanne; McAteer, John; Besser, Sarah; Charlett, Andre; Hayward, Andrew; Cookson, Barry D.; Cooper, Ben S.; Duckworth, Georgia; Jeanes, Annette; Roberts, Jenny; Teare, Louise; Stone, Sheldon

    2012-01-01

    Introduction Achieving a sustained improvement in hand-hygiene compliance is the WHO’s first global patient safety challenge. There is no RCT evidence showing how to do this. Systematic reviews suggest feedback is most effective and call for long term well designed RCTs, applying behavioural theory to intervention design to optimise effectiveness. Methods Three year stepped wedge cluster RCT of a feedback intervention testing hypothesis that the intervention was more effective than routine practice in 16 English/Welsh Hospitals (16 Intensive Therapy Units [ITU]; 44 Acute Care of the Elderly [ACE] wards) routinely implementing a national cleanyourhands campaign). Intervention-based on Goal & Control theories. Repeating 4 week cycle (20 mins/week) of observation, feedback and personalised action planning, recorded on forms. Computer-generated stepwise entry of all hospitals to intervention. Hospitals aware only of own allocation. Primary outcome: direct blinded hand hygiene compliance (%). Results All 16 trusts (60 wards) randomised, 33 wards implemented intervention (11 ITU, 22 ACE). Mixed effects regression analysis (all wards) accounting for confounders, temporal trends, ward type and fidelity to intervention (forms/month used). Intention to Treat Analysis Estimated odds ratio (OR) for hand hygiene compliance rose post randomisation (1.44; 95% CI 1.18, 1.76;phand-hygiene compliance, in wards implementing a national hand-hygiene campaign. Further implementation studies are needed to maximise the intervention’s effect in different settings. Trial Registration Controlled-Trials.com ISRCTN65246961 PMID:23110040

  13. Novel Ordered Stepped-Wedge Cluster Trial Designs for Detecting Ebola Vaccine Efficacy Using a Spatially Structured Mathematical Model.

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    Ibrahim Diakite

    2016-08-01

    Full Text Available During the 2014 Ebola virus disease (EVD outbreak, policy-makers were confronted with difficult decisions on how best to test the efficacy of EVD vaccines. On one hand, many were reluctant to withhold a vaccine that might prevent a fatal disease from study participants randomized to a control arm. On the other, regulatory bodies called for rigorous placebo-controlled trials to permit direct measurement of vaccine efficacy prior to approval of the products. A stepped-wedge cluster study (SWCT was proposed as an alternative to a more traditional randomized controlled vaccine trial to address these concerns. Here, we propose novel "ordered stepped-wedge cluster trial" (OSWCT designs to further mitigate tradeoffs between ethical concerns, logistics, and statistical rigor.We constructed a spatially structured mathematical model of the EVD outbreak in Sierra Leone. We used the output of this model to simulate and compare a series of stepped-wedge cluster vaccine studies. Our model reproduced the observed order of first case occurrence within districts of Sierra Leone. Depending on the infection risk within the trial population and the trial start dates, the statistical power to detect a vaccine efficacy of 90% varied from 14% to 32% for standard SWCT, and from 67% to 91% for OSWCTs for an alpha error of 5%. The model's projection of first case occurrence was robust to changes in disease natural history parameters.Ordering clusters in a step-wedge trial based on the cluster's underlying risk of infection as predicted by a spatial model can increase the statistical power of a SWCT. In the event of another hemorrhagic fever outbreak, implementation of our proposed OSWCT designs could improve statistical power when a step-wedge study is desirable based on either ethical concerns or logistical constraints.

  14. The prevention and reduction of weight loss in an acute tertiary care setting: protocol for a pragmatic stepped wedge randomised cluster trial (the PRoWL project)

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    2013-01-01

    Background Malnutrition, with accompanying weight loss, is an unnecessary risk in hospitalised persons and often remains poorly recognised and managed. The study aims to evaluate a hospital-wide multifaceted intervention co-facilitated by clinical nurses and dietitians addressing the nutritional care of patients, particularly those at risk of malnutrition. Using the best available evidence on reducing and preventing unplanned weight loss, the intervention (introducing universal nutritional screening; the provision of oral nutritional supplements; and providing red trays and additional support for patients in need of feeding) will be introduced by local ward teams in a phased way in a large tertiary acute care hospital. Methods/Design A pragmatic stepped wedge randomised cluster trial with repeated cross section design will be conducted. The unit of randomisation is the ward, with allocation by a random numbers table. Four groups of wards (n = 6 for three groups, n = 7 for one group) will be randomly allocated to each intervention time point over the trial. Two trained local facilitators (a nurse and dietitian for each group) will introduce the intervention. The primary outcome measure is change in patient’s body weight, secondary patient outcomes are: length of stay, all-cause mortality, discharge destinations, readmission rates and ED presentations. Patient outcomes will be measured on one ward per group, with 20 patients measured per ward per time period by an unblinded researcher. Including baseline, measurements will be conducted at five time periods. Staff perspectives on the context of care will be measured with the Alberta Context Tool. Discussion Unplanned and unwanted weight loss in hospital is common. Despite the evidence and growing concern about hospital nutrition there are very few evaluations of system-wide nutritional implementation programs. This project will test the implementation of a nutritional intervention across one hospital system using a

  15. Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: Results from a systematic review.

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    Taljaard, Monica; Hemming, Karla; Shah, Lena; Giraudeau, Bruno; Grimshaw, Jeremy M; Weijer, Charles

    2017-08-01

    Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting. Our aims were to assess the adequacy of the ethical conduct and reporting of stepped wedge trials to date, focusing on research ethics review and informed consent. Methods We conducted a systematic review of stepped wedge cluster randomized trials in health research published up to 2014 in English language journals. We extracted details of study intervention and data collection procedures, as well as reporting of research ethics review and informed consent. Two reviewers independently extracted data from each trial; discrepancies were resolved through discussion. We identified the presence of any research participants at the cluster level and the individual level. We assessed ethical conduct by tabulating reporting of research ethics review and informed consent against the presence of research participants. Results Of 32 identified stepped wedge trials, only 24 (75%) reported review by a research ethics committee, and only 16 (50%) reported informed consent from any research participants-yet, all trials included research participants at some level. In the subgroup of 20 trials with research participants at cluster level, only 4 (20%) reported informed consent from such participants; in 26 trials with individual-level research participants, only 15 (58%) reported their informed consent. Interventions (regardless of whether targeting cluster- or individual-level participants) were delivered at the group level in more than two-thirds of trials; nine trials (28

  16. 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.

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    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

  17. Protocol of a cluster randomised stepped-wedge trial of behavioural interventions targeting amphetamine-type stimulant use and sexual risk among female entertainment and sex workers in Cambodia.

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    Page, Kimberly; Stein, Ellen S; Carrico, Adam W; Evans, Jennifer L; Sokunny, Muth; Nil, Ean; Ngak, Song; Sophal, Chhit; McCulloch, Charles; Maher, Lisa

    2016-05-09

    HIV risk among female entertainment and sex workers (FESW) remains high and use of amphetamine-type stimulants (ATS) significantly increases this risk. We designed a cluster randomised stepped wedge trial (The Cambodia Integrated HIV and Drug Prevention Implementation (CIPI) study) to test sequentially delivered behavioural interventions targeting ATS use. The trial combines a 12-week Conditional Cash Transfer (CCT) intervention with 4 weeks of cognitive-behavioural group aftercare (AC) among FESW who use ATS. The primary goal is to reduce ATS use and unprotected sex among FESW. The CCT+AC intervention is being implemented in 10 provinces where order of delivery was randomised. Outcome assessments (OEs) including biomarkers and self-reported measures of recent sexual and drug use behaviours are conducted prior to implementation, and at three 6-month intervals after completion. Consultation with multiple groups and stakeholders on implementation factors facilitated acceptance and operationalisation of the trial. Statistical power and sample size calculations were based on expected changes in ATS use and unprotected sex at the population level as well as within subjects. Ethical approvals were granted by the Cambodia National Ethics Committee; University of New Mexico; University of California, San Francisco; and FHI360. The trial is registered with ClinicalTrials.gov. Dissemination of process indicators during the multiyear trial is carried out through annual in-country Stakeholder Meetings. Provincial 'Close-Out' forums are held at the conclusion of data collection in each province. When analysis is completed, dissemination meetings will be held in Cambodia with stakeholders, including community-based discussion sessions, policy briefs and results published and presented in the HIV prevention scientific journals and conferences. CIPI is the first trial of an intervention to reduce ATS use and HIV risk among FESW in Cambodia. Will inform both CCT+AC implementation

  18. Reducing Medical Admissions into Hospital through Optimising Medicines (REMAIN HOME) Study: protocol for a stepped-wedge, cluster-randomised trial

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    Foot, Holly; Freeman, Christopher; Hemming, Karla; Scott, Ian; Coombes, Ian D; Williams, Ian D; Connelly, Luke; Whitty, Jennifer A; Sturman, Nancy; Kirsa, Sue; Nicholson, Caroline; Russell, Grant; Kirkpatrick, Carl; Cottrell, Neil

    2017-01-01

    Introduction A model of general practitioner (GP) and pharmacist collaboration in primary care may be an effective strategy to reduce medication-related problems and provide better support to patients after discharge. The aim of this study is to investigate whether a model of structured pharmacist and GP care reduces hospital readmissions in high-risk patients. Methods and analysis This protocol details a stepped-wedge, cluster-randomised trial that will recruit participants over 9 months with a 12-month follow-up. There will be 14 clusters each representing a different general practice medical centre. A total of 2240 participants will be recruited from hospital who attend an enrolled medical centre, take five or more long-term medicines or whose reason for admission was related to heart failure or chronic obstructive pulmonary disease. The intervention is a multifaceted service, involving a pharmacist integrated into a medical centre to assist patients after hospitalisation. Participants will meet with the practice pharmacist and their GP after discharge to review and reconcile their medicines and discuss changes made in hospital. The pharmacist will follow-up with the participant and liaise with other health professionals involved in the participant’s care. The control will be usual care, which usually involves a patient self-organising a visit to their GP after hospital discharge. The primary outcome is the rate of unplanned, all-cause hospital readmissions over 12 months, which will be analysed using a mixed effects Poisson regression model with a random effect for cluster and a fixed effect to account for any temporal trend. A cost analysis will be undertaken to compare the healthcare costs associated with the intervention to those of usual care. Ethics and dissemination The study has received ethical approval (HREC/16/QRBW/410). The study findings will be disseminated through peer-reviewed publications, conferences and reports to key stakeholders. Trial

  19. The efficacy of Protected Mealtimes in hospitalised patients: a stepped wedge cluster randomised controlled trial.

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    Porter, Judi; Haines, Terry P; Truby, Helen

    2017-02-07

    Protected Mealtimes is an intervention developed to address the problem of malnutrition in hospitalised patients through increasing positive interruptions (such as feeding assistance) whilst minimising unnecessary interruptions (including ward rounds and diagnostic procedures) during mealtimes. This clinical trial aimed to measure the effect of implementing Protected Mealtimes on the energy and protein intake of patients admitted to the subacute setting. A prospective, stepped wedge cluster randomised controlled trial was undertaken across three hospital sites at one health network in Melbourne, Australia. All patients, except those receiving end-of-life care or not receiving oral nutrition, admitted to these wards during the study period participated. The intervention was guided by the British Hospital Caterers Association reference policy on Protected Mealtimes and by principles of implementation science. Primary outcome measures were daily energy and protein intake. The study was powered to determine whether the intervention closed the daily energy deficit between estimated intake and energy requirements measured as 1900 kJ/day in the pilot study for this trial. There were 149 unique participants, including 38 who crossed over from the control to intervention period as the Protected Mealtimes intervention was implemented. In total, 416 observations of 24-hour food intake were obtained. Energy intake was not significantly different between the intervention ([mean ± SD] 6479 ± 2486 kJ/day) and control (6532 ± 2328 kJ/day) conditions (p = 0.88). Daily protein intake was also not significantly different between the intervention (68.6 ± 26.0 g/day) and control (67.0 ± 25.2 g/day) conditions (p = 0.86). The differences between estimated energy/protein requirements and estimated energy/protein intakes were also limited between groups. The adjusted analysis yielded significant findings for energy deficit: (coefficient [robust 95% CI], p

  20. The use of feasibility studies for stepped-wedge cluster randomised trials: protocol for a review of impact and scope.

    Science.gov (United States)

    Kristunas, Caroline A; Hemming, Karla; Eborall, Helen C; Gray, Laura J

    2017-08-01

    The stepped-wedge cluster randomised trial (SW-CRT) is a complex design, for which many decisions about key design parameters must be made during the planning. These include the number of steps and the duration of time needed to embed the intervention. Feasibility studies are likely to be useful for informing these decisions and increasing the likelihood of the main trial's success. However, the number of feasibility studies being conducted for SW-CRTs is currently unknown. This review aims to establish the number of feasibility studies being conducted for SW-CRTs and determine which feasibility issues are commonly investigated. Fully published feasibility studies for SW-CRTs will be identified, according to predefined inclusion criteria, from searches conducted in Ovid MEDLINE, Scopus, Embase and PsycINFO. To also identify and gain information on unpublished feasibility studies the following will be contacted: authors of published SW-CRTs (identified from the most recent systematic reviews); contacts for registered SW-CRTs (identified from clinical trials registries); lead statisticians of UK registered clinical trials units and researchers known to work in the area of SW-CRTs.Data extraction will be conducted independently by two reviewers. For the fully published feasibility studies, data will be extracted on the study characteristics, the rationale for the study, the process for determining progression to a main trial, how the study informed the main trial and whether the main trial went ahead. The researchers involved in the unpublished feasibility studies will be contacted to elicit the same information.A narrative synthesis will be conducted and provided alongside a descriptive analysis of the study characteristics. This review does not require ethical approval, as no individual patient data will be used. The results of this review will be published in an open-access peer-reviewed journal. © Article author(s) (or their employer(s) unless otherwise stated in

  1. Translating staff experience into organisational improvement: the HEADS-UP stepped wedge, cluster controlled, non-randomised trial

    Science.gov (United States)

    Athanasiou, Thanos; Long, Susannah J; Beveridge, Iain; Sevdalis, Nick

    2017-01-01

    Objectives Frontline insights into care delivery correlate with patients’ clinical outcomes. These outcomes might be improved through near-real time identification and mitigation of staff concerns. We evaluated the effects of a prospective frontline surveillance system on patient and team outcomes. Design Prospective, stepped wedge, non-randomised, cluster controlled trial; prespecified per protocol analysis for high-fidelity intervention delivery. Participants Seven interdisciplinary medical ward teams from two hospitals in the UK. Intervention Prospective clinical team surveillance (PCTS): structured daily interdisciplinary briefings to capture staff concerns, with organisational facilitation and feedback. Main measures The primary outcome was excess length of stay (eLOS): an admission more than 24 hours above the local average for comparable patients. Secondary outcomes included safety and teamwork climates, and incident reporting. Mixed-effects models adjusted for time effects, age, comorbidity, palliation status and ward admissions. Safety and teamwork climates were measured with the Safety Attitudes Questionnaire. High-fidelity PCTS delivery comprised high engagement and high briefing frequency. Results Implementation fidelity was variable, both in briefing frequency (median 80% working days/month, IQR 65%–90%) and engagement (median 70 issues/ward/month, IQR 34–113). 1714/6518 (26.3%) intervention admissions had eLOS versus 1279/4927 (26.0%) control admissions, an absolute risk increase of 0.3%. PCTS increased eLOS in the adjusted intention-to-treat model (OR 1.32, 95% CI 1.10 to 1.58, p=0.003). Conversely, high-fidelity PCTS reduced eLOS (OR 0.79, 95% CI 0.67 to 0.94, p=0.006). High-fidelity PCTS also increased total, high-yield and non-nurse incident reports (incidence rate ratios 1.28–1.79, all p<0.002). Sustained PCTS significantly improved safety and teamwork climates over time. Conclusions This study highlighted the potential benefits and

  2. Cost-effectiveness of a multifaceted implementation strategy for the Dutch multidisciplinary guideline for nonspecific low back pain: design of a stepped-wedge cluster randomised controlled trial.

    Science.gov (United States)

    Suman, Arnela; Schaafsma, Frederieke G; Elders, Petra J M; van Tulder, Maurits W; Anema, Johannes R

    2015-05-31

    Low back pain (LBP) is one of the most prevalent and expensive health care problems in industrialised countries. LBP leads to high health care utility and productivity losses; leaving the individual, the employer, and society with substantial costs. To improve the care for LBP patients and reduce the high societal and financial burden of LBP, in 2010 the 'Multidisciplinary care guideline for nonspecific low back pain' was developed in the Netherlands. The current paper describes the design of a study aiming to evaluate the (cost-) effectiveness of a multifaceted strategy to implement this guideline. In a cluster-randomised controlled trial, the (cost-) effectiveness of a multifaceted implementation strategy will be compared to passive guideline dissemination. Using a stepped-wedge approach, participating general practitioners, physiotherapists, and occupational physicians are allocated into clusters and will attend a multidisciplinary continuing medical education training session. The timing these clusters receive the training is the unit of randomisation. LBP patients visiting the participating health care providers are invited to participate in the trial and will receive access to a multimedia intervention aimed at improving beliefs, cognitions, and self-management. The primary outcome measure of this study is patient back beliefs. Secondary outcome measures on patient level include pain, functional status, quality of life, health care utility, and productivity losses. Outcome measures on professional level include knowledge and attitude towards the guideline, and guideline adherence. A process evaluation for the implementation strategy will be performed among the health care providers and the patients. Furthermore, a qualitative subgroup analysis among patients with various ethnic backgrounds will be performed. This study will give insight into the (cost-) effectiveness of a multifaceted implementation strategy for the Dutch multidisciplinary guideline for non

  3. Protocol for a cluster randomised stepped wedge trial assessing the impact of a community-level hygiene intervention and a water intervention using riverbank filtration technology on diarrhoeal prevalence in India.

    Science.gov (United States)

    McGuinness, Sarah L; O'Toole, Joanne E; Boving, Thomas B; Forbes, Andrew B; Sinclair, Martha; Gautam, Sumit K; Leder, Karin

    2017-03-17

    Diarrhoea is a leading cause of death globally, mostly occurring as a result of insufficient or unsafe water supplies, inadequate sanitation and poor hygiene. Our study aims to investigate the impact of a community-level hygiene education program and a water quality intervention using riverbank filtration (RBF) technology on diarrhoeal prevalence. We have designed a stepped wedge cluster randomised trial to estimate the health impacts of our intervention in 4 rural villages in Karnataka, India. At baseline, surveys will be conducted in all villages, and householders will receive hygiene education. New pipelines, water storage tanks and taps will then be installed at accessible locations in each village and untreated piped river water will be supplied. A subsequent survey will evaluate the impact of hygiene education combined with improved access to greater water volumes for hygiene and drinking purposes (improved water quantity). Villages will then be randomly ordered and RBF-treated water (improved water quality) will be sequentially introduced into the 4 villages in a stepwise manner, with administration of surveys at each time point. The primary outcome is a 7-day period prevalence of self-reported diarrhoea. Secondary outcomes include self-reported respiratory and skin infections, and reported changes in hygiene practices, household water usage and water supply preference. River, tank and tap water from each village, and stored water from a subset of households, will be sampled to assess microbial and chemical quality. Ethics approval was obtained from the Monash University Human Research Ethics Committee in Australia and The Energy and Resources Institute Institutional Ethics Committee in India. The results of the trial will be presented at conferences, published in peer-reviewed journals and disseminated to relevant stakeholders. This study is funded by an Australian National Health and Medical Research Council (NHMRC) project grant. ACTRN12616001286437; pre

  4. Cost-Effectiveness of a Chronic Care Model for Frail Older Adults in Primary Care: Economic Evaluation Alongside a Stepped-Wedge Cluster-Randomized Trial

    NARCIS (Netherlands)

    van Leeuwen, K.M.; Bosmans, J.E.; Jansen, A.P.D.; Hoogendijk, E.O.; Muntinga, M.E.; van Hout, H.P.J.; Nijpels, G.; van der Horst, H.E.; van Tulder, M.W.

    2015-01-01

    Objectives To evaluate the cost-effectiveness of the Geriatric Care Model (GCM), an integrated care model for frail older adults based on the Chronic Care Model, with that of usual care. Design Economic evaluation alongside a 24-month stepped-wedge cluster-randomized controlled trial. Setting

  5. Cost-Effectiveness of a Chronic Care Model for Frail Older Adults in Primary Care : Economic Evaluation Alongside a Stepped-Wedge Cluster-Randomized Trial

    NARCIS (Netherlands)

    van Leeuwen, Karen M; Bosmans, Judith E; Jansen, Aaltje P D; Hoogendijk, Emiel O; Muntinga, Maaike E; van Hout, Hein P J; Nijpels, Giel; van der Horst, Henriette E; van Tulder, Maurits W

    2015-01-01

    OBJECTIVES: To evaluate the cost-effectiveness of the Geriatric Care Model (GCM), an integrated care model for frail older adults based on the Chronic Care Model, with that of usual care. DESIGN: Economic evaluation alongside a 24-month stepped-wedge cluster-randomized controlled trial. SETTING:

  6. Stepped-wedge cluster-randomised controlled trial to assess the cardiovascular health effects of a managed aquifer recharge initiative to reduce drinking water salinity in southwest coastal Bangladesh: study design and rationale.

    Science.gov (United States)

    Naser, Abu Mohd; Unicomb, Leanne; Doza, Solaiman; Ahmed, Kazi Matin; Rahman, Mahbubur; Uddin, Mohammad Nasir; Quraishi, Shamshad B; Selim, Shahjada; Shamsudduha, Mohammad; Burgess, William; Chang, Howard H; Gribble, Matthew O; Clasen, Thomas F; Luby, Stephen P

    2017-09-01

    Saltwater intrusion and salinisation have contributed to drinking water scarcity in many coastal regions globally, leading to dependence on alternative sources for water supply. In southwest coastal Bangladesh, communities have few options but to drink brackish groundwater which has been associated with high blood pressure among the adult population, and pre-eclampsia and gestational hypertension among pregnant women. Managed aquifer recharge (MAR), the purposeful recharge of surface water or rainwater to aquifers to bring hydrological equilibrium, is a potential solution for salinity problem in southwest coastal Bangladesh by creating a freshwater lens within the brackish aquifer. Our study aims to evaluate whether consumption of MAR water improves human health, particularly by reducing blood pressure among communities in coastal Bangladesh. The study employs a stepped-wedge cluster-randomised controlled community trial design in 16 communities over five monthly visits. During each visit, we will collect data on participants' source of drinking and cooking water and measure the salinity level and electrical conductivity of household stored water. At each visit, we will also measure the blood pressure of participants ≥20 years of age and pregnant women and collect urine samples for urinary sodium and protein measurements. We will use generalised linear mixed models to determine the association of access to MAR water on blood pressure of the participants. The study protocol has been reviewed and approved by the Institutional Review Boards of the International Centre for Diarrheal Disease Research, Bangladesh (icddr,b). Informed written consent will be taken from all the participants. This study is funded by Wellcome Trust, UK. The study findings will be disseminated to the government partners, at research conferences and in peer-reviewed journals. NCT02746003; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the

  7. Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): study protocol for a randomised, stepped-wedge cluster trial within the EFFECTS trial.

    Science.gov (United States)

    Lundström, Erik; Isaksson, Eva; Wester, Per; Laska, Ann-Charlotte; Näsman, Per

    2018-01-08

    Many randomised controlled trials (RCTs) fail to meet their recruitment goals in time. Trialists are advised to include study recruitment strategies within their trials. EFFECTS is a Swedish, academic-led RCT of fluoxetine for stroke recovery. The trial's primary objective is to investigate whether 20 mg fluoxetine daily compared with placebo for 6 months after an acute stroke improves the patient's functional outcome. The first patient was included on 20 October 2014 and, as of 31 August 2017, EFFECTS has included 810 of planned 1500 individuals. EFFECTS currently has 32 active centres. The primary objective of the ERUTECC (Enhancing Recruitment Using Teleconference and Commitment Contract) study is to investigate whether a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% at 60 days post intervention, compared with 60 days pre-intervention, in an ongoing RCT. ERUTECC is a randomised, stepped-wedge cluster trial embedded in EFFECTS. The plan is to start ERUTECC with a running-in period of September 2017. The first intervention is due in October 2017, and the study will continue for 12 months. We are planning to intervene at all active centres in EFFECTS, except the five top recruiting centres (n = 27). The rationale for not intervening at the top recruiting centres is that we believe they have reached their full potential and the intervention would be too weak for them. The hypothesis of this study is that a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% 60 days post intervention, compared to 60 days pre-intervention, in an ongoing RCT. EFFECTS is a large, pragmatic RCT of stroke in Sweden. Results from the embedded ERUTECC study could probably be generalised to high-income Western countries, and is relevant to trial management and could improve trial management in the

  8. Effectiveness, cost-utility and implementation of a decision aid for patients with localised prostate cancer and their partners: study protocol of a stepped-wedge cluster randomised controlled trial.

    Science.gov (United States)

    Al-Itejawi, Hoda H M; van Uden-Kraan, Cornelia F; van de Ven, Peter M; Coupé, Veerle M H; Vis, André N; Nieuwenhuijzen, Jakko A; van Moorselaar, Jeroen A; Verdonck-de Leeuw, Irma M

    2017-09-15

    Patient decision aids (PDAs) have been developed to help patients make an informed choice for a treatment option. Despite proven benefits, structural implementation falls short of expectations. The present study aims to assess the effectiveness and cost-utility of the PDA among newly diagnosed patients with localised prostate cancer and their partners, alongside implementation of the PDA in routine care. A stepped-wedge cluster randomised trial will be conducted. The PDA will be sequentially implemented in 18 hospitals in the Netherlands, over a period of 24 months. Every 3 or 6 months, a new cluster of hospitals will switch from usual care to care including a PDA.The primary outcome measure is decisional conflict experienced by the patient. Secondary outcomes comprise the patient's quality of life, treatment preferences, role in the decision making, expectations of treatment, knowledge, need for supportive care and decision regret. Furthermore, societal cost-utility will be valued. Other outcome measures considered are the partner's treatment preferences, experienced participation to decision making, quality of life, communication between patient, partner and health care professional, and the effect of prostate cancer on the relationship, social contacts and their role as caregiver. Patients and partners receiving the PDA will also be asked about their satisfaction with the PDA.Baseline assessment takes place after the treatment choice and before the start of a treatment, with follow-up assessments at 3, 6 and 12 months following the end of treatment or the day after deciding on active surveillance. Outcome measures on implementation include the implementation rate (defined as the proportion of all eligible patients who will receive a PDA) and a questionnaire for health care professionals on determinants of implementing an innovation. This study will be conducted in accordance with local laws and regulations of the Medical Ethics Committee of VU University Medical

  9. Effectiveness, cost-utility and implementation of a decision aid for patients with localised prostate cancer and their partners: study protocol of a stepped-wedge cluster randomised controlled trial

    Science.gov (United States)

    Al-Itejawi, Hoda H M; van Uden-Kraan, Cornelia F; van de Ven, Peter M; Coupé, Veerle M H; Vis, André N; Nieuwenhuijzen, Jakko A; van Moorselaar, Jeroen A; Verdonck-de Leeuw, Irma M

    2017-01-01

    Introduction Patient decision aids (PDAs) have been developed to help patients make an informed choice for a treatment option. Despite proven benefits, structural implementation falls short of expectations. The present study aims to assess the effectiveness and cost-utility of the PDA among newly diagnosed patients with localised prostate cancer and their partners, alongside implementation of the PDA in routine care. Methods/analysis A stepped-wedge cluster randomised trial will be conducted. The PDA will be sequentially implemented in 18 hospitals in the Netherlands, over a period of 24 months. Every 3 or 6 months, a new cluster of hospitals will switch from usual care to care including a PDA. The primary outcome measure is decisional conflict experienced by the patient. Secondary outcomes comprise the patient’s quality of life, treatment preferences, role in the decision making, expectations of treatment, knowledge, need for supportive care and decision regret. Furthermore, societal cost-utility will be valued. Other outcome measures considered are the partner’s treatment preferences, experienced participation to decision making, quality of life, communication between patient, partner and health care professional, and the effect of prostate cancer on the relationship, social contacts and their role as caregiver. Patients and partners receiving the PDA will also be asked about their satisfaction with the PDA. Baseline assessment takes place after the treatment choice and before the start of a treatment, with follow-up assessments at 3, 6 and 12 months following the end of treatment or the day after deciding on active surveillance. Outcome measures on implementation include the implementation rate (defined as the proportion of all eligible patients who will receive a PDA) and a questionnaire for health care professionals on determinants of implementing an innovation. Ethics and dissemination This study will be conducted in accordance with local laws and

  10. Can an e-learning course improve nursing care for older people at risk of delirium: a stepped wedge cluster randomised trial.

    Science.gov (United States)

    van de Steeg, Lotte; IJkema, Roelie; Langelaan, Maaike; Wagner, Cordula

    2014-05-27

    Delirium occurs frequently in older hospitalised patients and is associated with several adverse outcomes. Ignorance among healthcare professionals and a failure to recognise patients suffering from delirium have been identified as the possible causes of poor care. The objective of the study was to determine whether e-learning can be an effective means of improving implementation of a quality improvement project in delirium care. This project aims primarily at improving the early recognition of older patients who are at risk of delirium. In a stepped wedge cluster randomised trial an e-learning course on delirium was introduced, aimed at nursing staff. The trial was conducted on general medical and surgical wards from 18 Dutch hospitals. The primary outcome measure was the delirium risk screening conducted by nursing staff, measured through monthly patient record reviews. Patient records from patients aged 70 and over admitted onto wards participating in the study were used for data collection. Data was also collected on the level of delirium knowledge of these wards' nursing staff. Records from 1,862 older patients were included during the control phase and from 1,411 patients during the intervention phase. The e-learning course on delirium had a significant positive effect on the risk screening of older patients by nursing staff (OR 1.8, p-value e-learning course also showed a significant positive effect on nurses' knowledge of delirium. Nurses who undertook a delirium e-learning course showed a greater adherence to the quality improvement project in delirium care. This improved the recognition of patients at risk and demonstrated that e-learning can be a valuable instrument for hospitals when implementing improvements in delirium care. The Netherlands National Trial Register (NTR). NTR2885.

  11. Can an e-learning course improve nursing care for older people at risk of delirium: a stepped wedge cluster randomised trial

    Science.gov (United States)

    2014-01-01

    Background Delirium occurs frequently in older hospitalised patients and is associated with several adverse outcomes. Ignorance among healthcare professionals and a failure to recognise patients suffering from delirium have been identified as the possible causes of poor care. The objective of the study was to determine whether e-learning can be an effective means of improving implementation of a quality improvement project in delirium care. This project aims primarily at improving the early recognition of older patients who are at risk of delirium. Methods In a stepped wedge cluster randomised trial an e-learning course on delirium was introduced, aimed at nursing staff. The trial was conducted on general medical and surgical wards from 18 Dutch hospitals. The primary outcome measure was the delirium risk screening conducted by nursing staff, measured through monthly patient record reviews. Patient records from patients aged 70 and over admitted onto wards participating in the study were used for data collection. Data was also collected on the level of delirium knowledge of these wards’ nursing staff. Results Records from 1,862 older patients were included during the control phase and from 1,411 patients during the intervention phase. The e-learning course on delirium had a significant positive effect on the risk screening of older patients by nursing staff (OR 1.8, p-value e-learning course also showed a significant positive effect on nurses’ knowledge of delirium. Conclusions Nurses who undertook a delirium e-learning course showed a greater adherence to the quality improvement project in delirium care. This improved the recognition of patients at risk and demonstrated that e-learning can be a valuable instrument for hospitals when implementing improvements in delirium care. Trial registration The Netherlands National Trial Register (NTR). Trial number: NTR2885. PMID:24884739

  12. Enhancing evidence-based diabetes and chronic disease control among local health departments: a multi-phase dissemination study with a stepped-wedge cluster randomized trial component.

    Science.gov (United States)

    Parks, Renee G; Tabak, Rachel G; Allen, Peg; Baker, Elizabeth A; Stamatakis, Katherine A; Poehler, Allison R; Yan, Yan; Chin, Marshall H; Harris, Jenine K; Dobbins, Maureen; Brownson, Ross C

    2017-10-18

    The rates of diabetes and prediabetes in the USA are growing, significantly impacting the quality and length of life of those diagnosed and financially burdening society. Premature death and disability can be prevented through implementation of evidence-based programs and policies (EBPPs). Local health departments (LHDs) are uniquely positioned to implement diabetes control EBPPs because of their knowledge of, and focus on, community-level needs, contexts, and resources. There is a significant gap, however, between known diabetes control EBPPs and actual diabetes control activities conducted by LHDs. The purpose of this study is to determine how best to support the use of evidence-based public health for diabetes (and related chronic diseases) control among local-level public health practitioners. This paper describes the methods for a two-phase study with a stepped-wedge cluster randomized trial that will evaluate dissemination strategies to increase the uptake of public health knowledge and EBPPs for diabetes control among LHDs. Phase 1 includes development of measures to assess practitioner views on and organizational supports for evidence-based public health, data collection using a national online survey of LHD chronic disease practitioners, and a needs assessment of factors influencing the uptake of diabetes control EBPPs among LHDs within one state in the USA. Phase 2 involves conducting a stepped-wedge cluster randomized trial to assess effectiveness of dissemination strategies with local-level practitioners at LHDs to enhance capacity and organizational support for evidence-based diabetes prevention and control. Twelve LHDs will be selected and randomly assigned to one of the three groups that cross over from usual practice to receive the intervention (dissemination) strategies at 8-month intervals; the intervention duration for groups ranges from 8 to 24 months. Intervention (dissemination) strategies may include multi-day in-person workshops, electronic

  13. A structural multidisciplinary approach to depression management in nursing-home residents: a multicentre, stepped-wedge cluster-randomised trial.

    Science.gov (United States)

    Leontjevas, Ruslan; Gerritsen, Debby L; Smalbrugge, Martin; Teerenstra, Steven; Vernooij-Dassen, Myrra J F J; Koopmans, Raymond T C M

    2013-06-29

    Depression in nursing-home residents is often under-recognised. We aimed to establish the effectiveness of a structural approach to its management. Between May 15, 2009, and April 30, 2011, we undertook a multicentre, stepped-wedge cluster-randomised trial in four provinces of the Netherlands. A network of nursing homes was invited to enrol one dementia and one somatic unit per nursing home. In enrolled units, nursing-home staff recruited residents, who were eligible as long as we had received written informed consent. Units were randomly allocated to one of five groups with computer-generated random numbers. A multidisciplinary care programme, Act in Case of Depression (AiD), was implemented at different timepoints in each group: at baseline, no groups were implenting the programme (usual care); the first group implemented it shortly after baseline; and other groups sequentially began implementation after assessments at intervals of roughly 4 months. Residents did not know when the intervention was being implemented or what the programme elements were; research staff were masked to intervention implementation, depression treatment, and results of previous assessments; and data analysts were masked to intervention implementation. The primary endpoint was depression prevalence in units, which was the proportion of residents per unit with a score of more than seven on the proxy-based Cornell scale for depression in dementia. Analyses were by intention to treat. This trial is registered with the Netherlands National Trial Register, number NTR1477. 16 dementia units (403 residents) and 17 somatic units (390 residents) were enrolled in the course of the study. In somatic units, AiD reduced prevalence of depression (adjusted effect size -7·3%, 95% CI -13·7 to -0·9). The effect was not significant in dementia units (0·6, -5·6 to 6·8) and differed significantly from that in somatic units (p=0·031). Adherence to depression assessment procedures was lower in dementia

  14. Implementation of immunochemical faecal occult blood test in general practice: a study protocol using a cluster-randomised stepped-wedge design.

    Science.gov (United States)

    Juul, Jakob Søgaard; Bro, Flemming; Hornung, Nete; Andersen, Berit Sanne; Laurberg, Søren; Olesen, Frede; Vedsted, Peter

    2016-07-11

    Colorectal cancer is a common malignancy and a leading cause of cancer-related death. Half of patients with colorectal cancer initially present with non-specific or vague symptoms. In the need for a safe low-cost test, the immunochemical faecal occult blood test (iFOBT) may be part of the evaluation of such patients in primary care. Currently, Danish general practitioners have limited access to this test. The aim of this article is to describe a study that will assess the uptake and clinical use of iFOBT in general practice. Furthermore, it will investigate the diagnostic value and the clinical implications of using iFOBT in general practice on patients presenting with non-alarm symptoms of colorectal cancer. The study uses a cluster-randomised stepped-wedge design and is conducted in the Central Denmark Region among 836 GPs in 381 general practices. The municipalities of the Region and their appertaining general practitioners will be included sequentially in the study during the first 7 months of the 1-year study period. The following intervention has been developed for the study: a mandatory intervention providing all general practitioners with a starting package of 10 iFOBTs, a clinical instruction on iFOBT use in general practice and online information material from the date of inclusion, and an optional intervention consisting of a continuous medical education on colorectal cancer diagnostics and use of iFOBT. This study is among the first and largest trials to investigate the diagnostic use and the clinical value of iFOBT on patients presenting with non-alarm symptoms of colorectal cancer. The findings will be of national and international importance for the future planning of colorectal cancer diagnostics, particularly for 'low-risk-but-not-no-risk' patients with non-alarm symptoms of colorectal cancer. A Trial of the Implementation of iFOBT in General Practice NCT02308384 . Date of registration: 26 November 2014.

  15. A community-based cluster randomised trial of safe storage to reduce pesticide self-poisoning in rural Sri Lanka

    DEFF Research Database (Denmark)

    Pearson, Melissa; Konradsen, Flemming; Gunnell, David

    2011-01-01

    . One approach to reducing access to pesticides is for households to store pesticides in lockable "safe-storage" containers. However, before this approach can be promoted, evidence is required on its effectiveness and safety. Methods/Design A community-based cluster randomised controlled trial has been...... at the 5% significance level. Secondary outcomes will include the incidence of all pesticide poisoning and total self-harm. Discussion This paper describes a large effectiveness study of a community intervention to reduce the burden of intentional poisoning in rural Sri Lanka. The study builds on a strong...... partnership between provincial health services, local and international researchers, and local communities. We discuss issues in relation to randomisation and contamination, engaging control villages, the intervention, and strategies to improve adherence. Trial Registritation The trial is registered...

  16. The PULSAR Specialist Care protocol: a stepped-wedge cluster randomized control trial of a training intervention for community mental health teams in recovery-oriented practice.

    Science.gov (United States)

    Shawyer, Frances; Enticott, Joanne C; Brophy, Lisa; Bruxner, Annie; Fossey, Ellie; Inder, Brett; Julian, John; Kakuma, Ritsuko; Weller, Penelope; Wilson-Evered, Elisabeth; Edan, Vrinda; Slade, Mike; Meadows, Graham N

    2017-05-08

    Recovery features strongly in Australian mental health policy; however, evidence is limited for the efficacy of recovery-oriented practice at the service level. This paper describes the Principles Unite Local Services Assisting Recovery (PULSAR) Specialist Care trial protocol for a recovery-oriented practice training intervention delivered to specialist mental health services staff. The primary aim is to evaluate whether adult consumers accessing services where staff have received the intervention report superior recovery outcomes compared to adult consumers accessing services where staff have not yet received the intervention. A qualitative sub-study aims to examine staff and consumer views on implementing recovery-oriented practice. A process evaluation sub-study aims to articulate important explanatory variables affecting the interventions rollout and outcomes. The mixed methods design incorporates a two-step stepped-wedge cluster randomized controlled trial (cRCT) examining cross-sectional data from three phases, and nested qualitative and process evaluation sub-studies. Participating specialist mental health care services in Melbourne, Victoria are divided into 14 clusters with half randomly allocated to receive the staff training in year one and half in year two. Research participants are consumers aged 18-75 years who attended the cluster within a previous three-month period either at baseline, 12 (step 1) or 24 months (step 2). In the two nested sub-studies, participation extends to cluster staff. The primary outcome is the Questionnaire about the Process of Recovery collected from 756 consumers (252 each at baseline, step 1, step 2). Secondary and other outcomes measuring well-being, service satisfaction and health economic impact are collected from a subset of 252 consumers (63 at baseline; 126 at step 1; 63 at step 2) via interviews. Interview-based longitudinal data are also collected 12 months apart from 88 consumers with a psychotic disorder

  17. The CORE study protocol: a stepped wedge cluster randomised controlled trial to test a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness in the community mental health setting

    Science.gov (United States)

    Palmer, Victoria J; Chondros, Patty; Piper, Donella; Callander, Rosemary; Weavell, Wayne; Godbee, Kali; Potiriadis, Maria; Richard, Lauralie; Densely, Konstancja; Herrman, Helen; Furler, John; Pierce, David; Schuster, Tibor; Iedema, Rick; Gunn, Jane

    2015-01-01

    Introduction User engagement in mental health service design is heralded as integral to health systems quality and performance, but does engagement improve health outcomes? This article describes the CORE study protocol, a novel stepped wedge cluster randomised controlled trial (SWCRCT) to improve psychosocial recovery outcomes for people with severe mental illness. Methods An SWCRCT with a nested process evaluation will be conducted over nearly 4 years in Victoria, Australia. 11 teams from four mental health service providers will be randomly allocated to one of three dates 9 months apart to start the intervention. The intervention, a modified version of Mental Health Experience Co-Design (MH ECO), will be delivered to 30 service users, 30 carers and 10 staff in each cluster. Outcome data will be collected at baseline (6 months) and at completion of each intervention wave. The primary outcome is improvement in recovery score using the 24-item Revised Recovery Assessment Scale for service users. Secondary outcomes are improvements to user and carer mental health and well-being using the shortened 8-item version of the WHOQOL Quality of Life scale (EUROHIS), changes to staff attitudes using the 19-item Staff Attitudes to Recovery Scale and recovery orientation of services using the 36-item Recovery Self Assessment Scale (provider version). Intervention and usual care periods will be compared using a linear mixed effects model for continuous outcomes and a generalised linear mixed effects model for binary outcomes. Participants will be analysed in the group that the cluster was assigned to at each time point. Ethics and dissemination The University of Melbourne, Human Research Ethics Committee (1340299.3) and the Federal and State Departments of Health Committees (Project 20/2014) granted ethics approval. Baseline data results will be reported in 2015 and outcomes data in 2017. Trial registration number Australian and New Zealand Clinical Trials Registry ACTRN

  18. The CORE study protocol: a stepped wedge cluster randomised controlled trial to test a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness in the community mental health setting.

    Science.gov (United States)

    Palmer, Victoria J; Chondros, Patty; Piper, Donella; Callander, Rosemary; Weavell, Wayne; Godbee, Kali; Potiriadis, Maria; Richard, Lauralie; Densely, Konstancja; Herrman, Helen; Furler, John; Pierce, David; Schuster, Tibor; Iedema, Rick; Gunn, Jane

    2015-03-24

    User engagement in mental health service design is heralded as integral to health systems quality and performance, but does engagement improve health outcomes? This article describes the CORE study protocol, a novel stepped wedge cluster randomised controlled trial (SWCRCT) to improve psychosocial recovery outcomes for people with severe mental illness. An SWCRCT with a nested process evaluation will be conducted over nearly 4 years in Victoria, Australia. 11 teams from four mental health service providers will be randomly allocated to one of three dates 9 months apart to start the intervention. The intervention, a modified version of Mental Health Experience Co-Design (MH ECO), will be delivered to 30 service users, 30 carers and 10 staff in each cluster. Outcome data will be collected at baseline (6 months) and at completion of each intervention wave. The primary outcome is improvement in recovery score using the 24-item Revised Recovery Assessment Scale for service users. Secondary outcomes are improvements to user and carer mental health and well-being using the shortened 8-item version of the WHOQOL Quality of Life scale (EUROHIS), changes to staff attitudes using the 19-item Staff Attitudes to Recovery Scale and recovery orientation of services using the 36-item Recovery Self Assessment Scale (provider version). Intervention and usual care periods will be compared using a linear mixed effects model for continuous outcomes and a generalised linear mixed effects model for binary outcomes. Participants will be analysed in the group that the cluster was assigned to at each time point. The University of Melbourne, Human Research Ethics Committee (1340299.3) and the Federal and State Departments of Health Committees (Project 20/2014) granted ethics approval. Baseline data results will be reported in 2015 and outcomes data in 2017. Australian and New Zealand Clinical Trials Registry ACTRN12614000457640. Published by the BMJ Publishing Group Limited. For

  19. Mixed methods evaluation of targeted case finding for cardiovascular disease prevention using a stepped wedged cluster RCT

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    Marshall Tom

    2012-10-01

    Full Text Available Abstract Background A pilot project cardiovascular prevention was implemented in Sandwell (West Midlands, UK. This used electronic primary care records to identify untreated patients at high risk of cardiovascular disease then invited these high risk patients for assessment by a nurse in their own general practice. Those found to be eligible for treatment were offered treatment. During the pilot a higher proportion of high risk patients were started on treatment in the intervention practices than in control practices. Following the apparent success of the prevention project, it was intended to extend the service to all practices across the Sandwell area. However the pilot project was not a robust evaluation. There was a need for an efficient evaluation that would not disrupt the planned rollout of the project. Methods/design Project nurses will sequentially implement targeted cardiovascular case finding in a phased way across all general practices, with the sequence of general practices determined randomly. This is a stepped wedge randomised controlled trial design. The target population is patients aged 35 to 74, without diabetes or cardiovascular disease whose ten-year cardiovascular risk, (determined from data in their electronic records is ≥20%. The primary outcome is the number of high risk patients started on treatment, because these data could be efficiently obtained from electronic primary care records. From this we can determine the effects of the case finding programme on the proportion of high risk patients started on treatment in practices before and after implementation of targeted case finding. Cost-effectiveness will be modelled from the predicted effects of treatments on cardiovascular events and associated health service costs. Alongside the implementation it is intended to interview clinical staff and patients who participated in the programme in order to determine acceptability to patients and clinicians. Practical

  20. Provision of medical supply kits to improve quality of antenatal care in Mozambique: a stepped-wedge cluster randomised trial.

    Science.gov (United States)

    Betrán, Ana Pilar; Bergel, Eduardo; Griffin, Sally; Melo, Armando; Nguyen, My Huong; Carbonell, Alicia; Mondlane, Santos; Merialdi, Mario; Temmerman, Marleen; Gülmezoglu, A Metin

    2018-01-01

    High levels of maternal and newborn mortality and morbidity remain a daunting reality in many low-income countries. Several interventions delivered during antenatal care have been shown to improve maternal and newborn outcomes, but stockouts of medical supplies at point of care can prevent implementation of these services. We aimed to evaluate whether a supply chain strategy based on the provision of kits could improve quality of care. We did a pragmatic, stepped-wedge, cluster-randomised controlled trial at ten antenatal care clinics in Mozambique. Clinics were eligible if they were not already implementing the proposed antenatal care package; they served at least 200 new pregnant women per year; they had Maternal and Child Health (MCH) nurses; and they were willing to participate. All women attending antenatal care visits at the participating clinics were included in the trial. Participating clinics were randomly assigned to shift from control to intervention on prespecified start dates. The intervention involved four components (kits with medical supplies, a cupboard to store these supplies, a tracking sheet to monitor stocks, and a one-day training session). The primary outcomes were the proportion of women screened for anaemia and proteinuria, and the proportion of women who received mebendazole in the first antenatal care visit. The intervention was delivered under routine care conditions, and analyses were done according to the intention-to-treat principle. This trial is registered with the Pan African Clinical Trial Registry, number PACTR201306000550192. Between March, 2014, and January, 2016, 218 277 antenatal care visits were registered, with 68 598 first and 149 679 follow-up visits. We found significant improvements in all three primary outcomes. In first visits, 5519 (14·6%) of 37 826 women were screened for anaemia in the control period, compared with 30 057 (97·7%) of 30 772 in the intervention period (adjusted odds ratio 832·40; 99

  1. Efficacy of community-based physiotherapy networks for patients with Parkinson's disease: a cluster-randomised trial.

    Science.gov (United States)

    Munneke, Marten; Nijkrake, Maarten J; Keus, Samyra Hj; Kwakkel, Gert; Berendse, Henk W; Roos, Raymund Ac; Borm, George F; Adang, Eddy M; Overeem, Sebastiaan; Bloem, Bastiaan R

    2010-01-01

    Many patients with Parkinson's disease are treated with physiotherapy. We have developed a community-based professional network (ParkinsonNet) that involves training of a selected number of expert physiotherapists to work according to evidence-based recommendations, and structured referrals to these trained physiotherapists to increase the numbers of patients they treat. We aimed to assess the efficacy of this approach for improving health-care outcomes. Between February, 2005, and August, 2007, we did a cluster-randomised trial with 16 clusters (defined as community hospitals and their catchment area). Clusters were randomly allocated by use of a variance minimisation algorithm to ParkinsonNet care (n=8) or usual care (n=8). Patients were assessed at baseline and at 8, 16, and 24 weeks of follow-up. The primary outcome was a patient preference disability score, the patient-specific index score, at 16 weeks. Health secondary outcomes were functional mobility, mobility-related quality of life, and total societal costs over 24 weeks. Analysis was by intention to treat. This trial is registered, number NCT00330694. We included 699 patients. Baseline characteristics of the patients were comparable between the ParkinsonNet clusters (n=358) and usual-care clusters (n=341). The primary endpoint was similar for patients within the ParkinsonNet clusters (mean 47.7, SD 21.9) and control clusters (48.3, 22.4). Health secondary endpoints were also similar for patients in both study groups. Total costs over 24 weeks were lower in ParkinsonNet clusters compared with usual-care clusters (difference euro727; 95% CI 56-1399). Implementation of ParkinsonNet networks did not change health outcomes for patients living in ParkinsonNet clusters. However, health-care costs were reduced in ParkinsonNet clusters compared with usual-care clusters. ZonMw; Netherlands Organisation for Scientific Research; Dutch Parkinson's Disease Society; National Parkinson Foundation; Stichting Robuust

  2. Effectiveness of Seasonal Malaria Chemoprevention in Children under Ten Years of Age in Senegal: A Stepped-Wedge Cluster-Randomised Trial.

    Directory of Open Access Journals (Sweden)

    Badara Cissé

    2016-11-01

    Full Text Available Seasonal Malaria Chemoprevention (SMC with sulfadoxine-pyrimethamine (SP plus amodiaquine (AQ, given each month during the transmission season, is recommended for children living in areas of the Sahel where malaria transmission is highly seasonal. The recommendation for SMC is currently limited to children under five years of age, but, in many areas of seasonal transmission, the burden in older children may justify extending this age limit. This study was done to determine the effectiveness of SMC in Senegalese children up to ten years of age.SMC was introduced into three districts over three years in central Senegal using a stepped-wedge cluster-randomised design. A census of the population was undertaken and a surveillance system was established to record all deaths and to record all cases of malaria seen at health facilities. A pharmacovigilance system was put in place to detect adverse drug reactions. Fifty-four health posts were randomised. Nine started implementation of SMC in 2008, 18 in 2009, and a further 18 in 2010, with 9 remaining as controls. In the first year of implementation, SMC was delivered to children aged 3-59 months; the age range was then extended for the latter two years of the study to include children up to 10 years of age. Cluster sample surveys at the end of each transmission season were done to measure coverage of SMC and the prevalence of parasitaemia and anaemia, to monitor molecular markers of drug resistance, and to measure insecticide-treated net (ITN use. Entomological monitoring and assessment of costs of delivery in each health post and of community attitudes to SMC were also undertaken. About 780,000 treatments were administered over three years. Coverage exceeded 80% each month. Mortality, the primary endpoint, was similar in SMC and control areas (4.6 and 4.5 per 1000 respectively in children under 5 years and 1.3 and 1.2 per 1000 in children 5-9 years of age; the overall mortality rate ratio [SMC: no SMC

  3. A cluster randomised stepped wedge trial to evaluate the effectiveness of a multifaceted information technology-based intervention in reducing high-risk prescribing of non-steroidal anti-inflammatory drugs and antiplatelets in primary medical care: The DQIP study protocol

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    Dreischulte Tobias

    2012-03-01

    Full Text Available Abstract Background High-risk prescribing of non-steroidal anti-inflammatory drugs (NSAIDs and antiplatelet agents accounts for a significant proportion of hospital admissions due to preventable adverse drug events. The recently completed PINCER trial has demonstrated that a one-off pharmacist-led information technology (IT-based intervention can significantly reduce high-risk prescribing in primary care, but there is evidence that effects decrease over time and employing additional pharmacists to facilitate change may not be sustainable. Methods/design We will conduct a cluster randomised controlled with a stepped wedge design in 40 volunteer general practices in two Scottish health boards. Eligible practices are those that are using the INPS Vision clinical IT system, and have agreed to have relevant medication-related data to be automatically extracted from their electronic medical records. All practices (clusters that agree to take part will receive the data-driven quality improvement in primary care (DQIP intervention, but will be randomised to one of 10 start dates. The DQIP intervention has three components: a web-based informatics tool that provides weekly updated feedback of targeted prescribing at practice level, prompts the review of individual patients affected, and summarises each patient's relevant risk factors and prescribing; an outreach visit providing education on targeted prescribing and training in the use of the informatics tool; and a fixed payment of 350 GBP (560 USD; 403 EUR up front and a small payment of 15 GBP (24 USD; 17 EUR for each patient reviewed in the 12 months of the intervention. We hypothesise that the DQIP intervention will reduce a composite of nine previously validated measures of high-risk prescribing. Due to the nature of the intervention, it is not possible to blind practices, the core research team, or the data analyst. However, outcome assessment is entirely objective and automated. There will

  4. Pressure ulcer multidisciplinary teams via telemedicine: a pragmatic cluster randomized stepped wedge trial in long term care.

    Science.gov (United States)

    Stern, Anita; Mitsakakis, Nicholas; Paulden, Mike; Alibhai, Shabbir; Wong, Josephine; Tomlinson, George; Brooker, Ann-Sylvia; Krahn, Murray; Zwarenstein, Merrick

    2014-02-24

    The study was conducted to determine the clinical and cost effectiveness of enhanced multi-disciplinary teams (EMDTs) vs. 'usual care' for the treatment of pressure ulcers in long term care (LTC) facilities in Ontario, Canada We conducted a multi-method study: a pragmatic cluster randomized stepped-wedge trial, ethnographic observation and in-depth interviews, and an economic evaluation. Long term care facilities (clusters) were randomly allocated to start dates of the intervention. An advance practice nurse (APN) with expertise in skin and wound care visited intervention facilities to educate staff on pressure ulcer prevention and treatment, supported by an off-site hospital based expert multi-disciplinary wound care team via email, telephone, or video link as needed. The primary outcome was rate of reduction in pressure ulcer surface area (cm2/day) measured on before and after standard photographs by an assessor blinded to facility allocation. Secondary outcomes were time to healing, probability of healing, pressure ulcer incidence, pressure ulcer prevalence, wound pain, hospitalization, emergency department visits, utility, and cost. 12 of 15 eligible LTC facilities were randomly selected to participate and randomized to start date of the intervention following the stepped wedge design. 137 residents with a total of 259 pressure ulcers (stage 2 or greater) were recruited over the 17 month study period. No statistically significant differences were found between control and intervention periods on any of the primary or secondary outcomes. The economic evaluation demonstrated a mean reduction in direct care costs of $650 per resident compared to 'usual care'. The qualitative study suggested that onsite support by APN wound specialists was welcomed, and is responsible for reduced costs through discontinuation of expensive non evidence based treatments. Insufficient allocation of nursing home staff time to wound care may explain the lack of impact on healing

  5. Impact of elementary school-located influenza vaccinations: A stepped wedge trial across a community.

    Science.gov (United States)

    Szilagyi, Peter G; Schaffer, Stanley; Rand, Cynthia M; Goldstein, Nicolas P N; Hightower, A Dirk; Younge, Mary; Eagan, Ashley; Blumkin, Aaron; Albertin, Christina S; DiBitetto, Kristine; Concannon, Cathleen; Vincelli, Phyllis; Yoo, Byung-Kwang; Humiston, Sharon G

    2018-05-11

    Influenza vaccination rates among children are low and novel strategies are needed to raise coverage. We measured the impact of school-located influenza vaccination (SLIV) on coverage, examined whether SLIV substitutes for practice-based influenza vaccination ("substitution"), and estimated whether a second year of experience with SLIV increases its impact. We implemented a stepped wedge study design with schools as clusters. In Year 1, we randomly allocated schools to SLIV or control. In Year 2, all schools performed SLIV. We used emails (suburban schools) or backpack fliers (both urban and suburban schools) to notify parents, and offered web-based (suburban) or paper-based vaccination (urban) consent forms. Local health department nurses administered SLIV vaccinations and billed insurers. We analyzed state immunization registry data to measure influenza vaccination rates. 42 schools (38,078 children) participated over 2 years. Overall vaccination rates were 5 and 7 percentage points higher among SLIV- school children versus control-school children in suburban (aOR 1.36, 95% CI 1.25-1.49 in Years 1-2 SLIV vs. Year 1 control schools) and urban schools (aOR 1.22, 95% CI 1.10-1.36), respectively, adjusting for prior year's vaccination and other covariates. While no substitution occurred among children attending suburban schools, some substitution occurred among children attending urban schools, although overall vaccination rates were still higher in urban schools due to SLIV. Compared to an initial year of SLIV, more children were vaccinated in a second year of SLIV at urban (8.3% vs. 6.8%, aOR 1.24, 95% CI 1.04-1.47) but not suburban schools (3.5% vs. 2.7%, aOR 1.24, 95% CI 0.98-1.57). In this stepped wedge trial, SLIV increased overall influenza vaccination rates in suburban and urban schools. Some substitution for primary care vaccination occurred in urban settings. A second year of SLIV expanded its reach slightly in urban schools. Copyright © 2018 Elsevier

  6. Fidelity considerations in translational research: Eating As Treatment - a stepped wedge, randomised controlled trial of a dietitian delivered behaviour change counselling intervention for head and neck cancer patients undergoing radiotherapy.

    Science.gov (United States)

    Beck, Alison Kate; Baker, Amanda; Britton, Ben; Wratten, Chris; Bauer, Judith; Wolfenden, Luke; Carter, Gregory

    2015-10-15

    The confidence with which researchers can comment on intervention efficacy relies on evaluation and consideration of intervention fidelity. Accordingly, there have been calls to increase the transparency with which fidelity methodology is reported. Despite this, consideration and/or reporting of fidelity methods remains poor. We seek to address this gap by describing the methodology for promoting and facilitating the evaluation of intervention fidelity in The EAT (Eating As Treatment) project: a multi-site stepped wedge randomised controlled trial of a dietitian delivered behaviour change counselling intervention to improve nutrition (primary outcome) in head and neck cancer patients undergoing radiotherapy. In accordance with recommendations from the National Institutes of Health Behaviour Change Consortium Treatment Fidelity Workgroup, we sought to maximise fidelity in this stepped wedge randomised controlled trial via strategies implemented from study design through to provider training, intervention delivery and receipt. As the EAT intervention is designed to be incorporated into standard dietetic consultations, we also address unique challenges for translational research. We offer a strong model for improving the quality of translational findings via real world application of National Institutes of Health Behaviour Change Consortium recommendations. Greater transparency in the reporting of behaviour change research is an important step in improving the progress and quality of behaviour change research. ACTRN12613000320752 (Date of registration 21 March 2013).

  7. Effectiveness of the HuCare Quality Improvement Strategy on health-related quality of life in patients with cancer: study protocol of a stepped-wedge cluster randomised controlled trial (HuCare2 study).

    Science.gov (United States)

    Caminiti, Caterina; Iezzi, Elisa; Passalacqua, Rodolfo

    2017-10-06

    Our group previously demonstrated the feasibility of the HuCare Quality Improvement Strategy (HQIS), aimed at integrating into practice six psychosocial interventions recommended by international guidelines. This trial will assess whether the introduction of the strategy in oncology wards improves patient's health-related quality of life (HRQoL). Multicentre, incomplete stepped-wedge cluster randomised controlled trial, conducted in three clusters of five centres each, in three equally spaced time epochs. The study also includes an initial epoch when none of the centres are exposed to the intervention, and a final epoch when all centres will have implemented the strategy. The intervention is applied at a cluster level, and assessed at an individual level with cross-sectional model. A total of 720 patients who received a cancer diagnosis in the previous 2 months and about to start medical treatment will be enrolled. The primary aim is to evaluate the effectiveness of the HQIS versus standard care in terms of improvement of at least one of two domains (emotional and social functions) of HRQoL using the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 items) questionnaire, at baseline and at 3 months. This outcome was chosen because patients with cancer generally exhibit low HRQoL, particularly at certain stages of care, and because it allows to assess the strategy's impact as perceived by patients themselves. The HQIS comprises three phases: (1) clinician training-to improve communication-relational skills and instruct on the project; (2) centre support-four on-site visits by experts of the project team, aimed to boost motivation, help with context analysis and identification of solutions; (3) implementation of Evidence-Based Medicine (EBM) recommendations at the centre. Ethics committee review approval has been obtained from the Ethics Committee of Parma. Results will be disseminated at conferences, and

  8. Balancing Opposing Forces—A Nested Process Evaluation Study Protocol for a Stepped Wedge Designed Cluster Randomized Controlled Trial of an Experience Based Codesign Intervention

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    Victoria Jane Palmer

    2016-10-01

    Full Text Available Background: Process evaluations are essential to understand the contextual, relational, and organizational and system factors of complex interventions. The guidance for developing process evaluations for randomized controlled trials (RCTs has until recently however, been fairly limited. Method/Design: A nested process evaluation (NPE was designed and embedded across all stages of a stepped wedge cluster RCT called the CORE study. The aim of the CORE study is to test the effectiveness of an experience-based codesign methodology for improving psychosocial recovery outcomes for people living with severe mental illness (service users. Process evaluation data collection combines qualitative and quantitative methods with four aims: (1 to describe organizational characteristics, service models, policy contexts, and government reforms and examine the interaction of these with the intervention; (2 to understand how the codesign intervention works, the cluster variability in implementation, and if the intervention is or is not sustained in different settings; (3 to assist in the interpretation of the primary and secondary outcomes and determine if the causal assumptions underpinning the codesign interventions are accurate; and (4 to determine the impact of a purposefully designed engagement model on the broader study retention and knowledge transfer in the trial. Discussion: Process evaluations require prespecified study protocols but finding a balance between their iterative nature and the structure offered by protocol development is an important step forward. Taking this step will advance the role of qualitative research within trials research and enable more focused data collection to occur at strategic points within studies.

  9. Improvement of perinatal and newborn care in rural Pakistan through community-based strategies: a cluster-randomised effectiveness trial.

    Science.gov (United States)

    Bhutta, Zulfiqar A; Soofi, Sajid; Cousens, Simon; Mohammad, Shah; Memon, Zahid A; Ali, Imran; Feroze, Asher; Raza, Farrukh; Khan, Amanullah; Wall, Steve; Martines, Jose

    2011-01-29

    Newborn deaths account for 57% of deaths in children younger than 5 years in Pakistan. Although a large programme of trained lady health workers (LHWs) exists, the effectiveness of this training on newborn outcomes has not been studied. We aimed to evaluate the effectiveness of a community-based intervention package, principally delivered through LHWs working with traditional birth attendants and community health committees, for reduction of perinatal and neonatal mortality in a rural district of Pakistan. We undertook a cluster randomised trial between February, 2006, and March, 2008, in Hala and Matiari subdistricts, Pakistan. Catchment areas of primary care facilities and all affiliated LHWs were used to define clusters, which were allocated to intervention and control groups by restricted, stratified randomisation. The intervention package delivered by LHWs through group sessions consisted of promotion of antenatal care and maternal health education, use of clean delivery kits, facility births, immediate newborn care, identification of danger signs, and promotion of careseeking; control clusters received routine care. Independent data collectors undertook quarterly household surveillance to capture data for births, deaths, and household practices related to maternal and newborn care. Data collectors were masked to cluster allocation; those analysing data were not. The primary outcome was perinatal and all-cause neonatal mortality. Analysis was by intention to treat. This trial is registered, ISRCTN16247511. 16 clusters were assigned to intervention (23,353 households, 12,391 total births) and control groups (23,768 households, 11,443 total births). LHWs in the intervention clusters were able to undertake 4428 (63%) of 7084 planned group sessions, but were only able to visit 2943 neonates (24%) of a total 12,028 livebirths in their catchment villages. Stillbirths were reduced in intervention clusters (39·1 stillbirths per 1000 total births) compared with

  10. Stepped-wedge cluster randomised controlled trial to assess the effectiveness of an electronic medication management system to reduce medication errors, adverse drug events and average length of stay at two paediatric hospitals: a study protocol.

    Science.gov (United States)

    Westbrook, J I; Li, L; Raban, M Z; Baysari, M T; Mumford, V; Prgomet, M; Georgiou, A; Kim, T; Lake, R; McCullagh, C; Dalla-Pozza, L; Karnon, J; O'Brien, T A; Ambler, G; Day, R; Cowell, C T; Gazarian, M; Worthington, R; Lehmann, C U; White, L; Barbaric, D; Gardo, A; Kelly, M; Kennedy, P

    2016-10-21

    Medication errors are the most frequent cause of preventable harm in hospitals. Medication management in paediatric patients is particularly complex and consequently potential for harms are greater than in adults. Electronic medication management (eMM) systems are heralded as a highly effective intervention to reduce adverse drug events (ADEs), yet internationally evidence of their effectiveness in paediatric populations is limited. This study will assess the effectiveness of an eMM system to reduce medication errors, ADEs and length of stay (LOS). The study will also investigate system impact on clinical work processes. A stepped-wedge cluster randomised controlled trial (SWCRCT) will measure changes pre-eMM and post-eMM system implementation in prescribing and medication administration error (MAE) rates, potential and actual ADEs, and average LOS. In stage 1, 8 wards within the first paediatric hospital will be randomised to receive the eMM system 1 week apart. In stage 2, the second paediatric hospital will randomise implementation of a modified eMM and outcomes will be assessed. Prescribing errors will be identified through record reviews, and MAEs through direct observation of nurses and record reviews. Actual and potential severity will be assigned. Outcomes will be assessed at the patient-level using mixed models, taking into account correlation of admissions within wards and multiple admissions for the same patient, with adjustment for potential confounders. Interviews and direct observation of clinicians will investigate the effects of the system on workflow. Data from site 1 will be used to develop improvements in the eMM and implemented at site 2, where the SWCRCT design will be repeated (stage 2). The research has been approved by the Human Research Ethics Committee of the Sydney Children's Hospitals Network and Macquarie University. Results will be reported through academic journals and seminar and conference presentations. Australian New Zealand

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

    Science.gov (United States)

    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

  12. Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE): study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Asher, Laura; De Silva, Mary; Hanlon, Charlotte; Weiss, Helen A; Birhane, Rahel; Ejigu, Dawit A; Medhin, Girmay; Patel, Vikram; Fekadu, Abebaw

    2016-06-24

    Care for most people with schizophrenia is best delivered in the community and evidence-based guidelines recommend combining both medication and a psychosocial intervention, such as community-based rehabilitation. There is emerging evidence that community-based rehabilitation for schizophrenia is effective at reducing disability in middle-income country settings, yet there is no published evidence on the effectiveness in settings with fewer mental health resources. This paper describes the protocol of a study that aims to evaluate the effectiveness of community-based rehabilitation as an adjunct to health facility-based care in rural Ethiopia. This is a cluster randomised trial set in a rural district in Ethiopia, with sub-district as the unit of randomisation. Participants will be recruited from an existing cohort of people with schizophrenia receiving treatment in primary care. Fifty-four sub-districts will be randomly allocated in a 1:1 ratio to facility-based care plus community-based rehabilitation (intervention arm) or facility-based care alone (control arm). Facility-based care consists of treatment by a nurse or health officer in primary care (antipsychotic medication, basic psychoeducation and follow-up) with referral to a psychiatric nurse-led outpatient clinic or psychiatric hospital when required. Trained community-based rehabilitation workers will deliver a manualised community-based rehabilitation intervention, with regular individual and group supervision. We aim to recruit 182 people with schizophrenia and their caregivers. Potential participants will be screened for eligibility, including enduring or disabling illness. Participants will be recruited after providing informed consent or, for participants without decision-making capacity, after the primary caregiver gives permission on behalf of the participant. The primary outcome is disability measured with the 36-item WHO Disability Assessment Schedule (WHODAS) version 2.0 at 12 months. The sample

  13. The effectiveness of a semi-tailored facilitator-based intervention to optimise chronic care management in general practice: a stepped-wedge randomised controlled trial.

    Science.gov (United States)

    Due, Tina Drud; Thorsen, Thorkil; Kousgaard, Marius Brostrøm; Siersma, Volkert Dirk; Waldorff, Frans Boch

    2014-04-09

    The Danish health care sector is reorganising based on disease management programmes designed to secure integrated and high quality chronic care across hospitals, general practitioners and municipalities. The disease management programmes assign a central role to general practice; and in the Capital Region of Denmark a facilitator-based intervention was undertaken to support the implementation of the programmes in general practice. The purpose of the study was to assess the effectiveness of this semi-tailored facilitator-based intervention. The study was a stepped-wedge, randomised, controlled trial among general practices in the Capital Region of Denmark. The intervention group was offered three one-hour visits by a facilitator. The intervention was semi-tailored to the perceived needs as defined by each general practice, and the practices could choose from a list of possible topics. The control group was a delayed intervention group. The primary outcome was change in the number of annual chronic disease check-ups. Secondary outcomes were: changes in the number of annual check-ups for type 2 diabetes (DM2) and chronic obstructive pulmonary disease (COPD); changes in the number of spirometry tests, changes in the use of ICPC diagnosis coding and patient stratification; sign-up for a software program for patient overview; and reduction in number of practices with few annual chronic disease check-ups. We randomised 189 general practices: 96 practices were allocated to the intervention group and 93 to the delayed intervention group. For the primary outcome, 94 and 89 practices were analysed. Almost every outcome improved from baseline to follow-up in both allocation groups. At follow-up there was no difference between allocation groups for the primary outcome (p = 0.1639). However, some secondary outcomes favoured the intervention: a higher reported use of ICPC diagnosis coding for DM2 and COPD (p = 0.0050, p = 0.0243 respectively), stratification for COPD (p = 0

  14. A stepped wedge, cluster-randomized trial of a household UV-disinfection and safe storage drinking water intervention in rural Baja California Sur, Mexico.

    Science.gov (United States)

    Gruber, Joshua S; Reygadas, Fermin; Arnold, Benjamin F; Ray, Isha; Nelson, Kara; Colford, John M

    2013-08-01

    In collaboration with a local non-profit organization, this study evaluated the expansion of a program that promoted and installed Mesita Azul, an ultraviolet-disinfection system designed to treat household drinking water in rural Mexico. We conducted a 15-month, cluster-randomized stepped wedge trial by randomizing the order in which 24 communities (444 households) received the intervention. We measured primary outcomes (water contamination and diarrhea) during seven household visits. The intervention increased the percentage of households with access to treated and safely stored drinking water (23-62%), and reduced the percentage of households with Escherichia coli contaminated drinking water (risk difference (RD): -19% [95% CI: -27%, -14%]). No significant reduction in diarrhea was observed (RD: -0.1% [95% CI: -1.1%, 0.9%]). We conclude that household water quality improvements measured in this study justify future promotion of the Mesita Azul, and that future studies to measure its health impact would be valuable if conducted in populations with higher diarrhea prevalence.

  15. 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

  16. The added value of a mobile application of Community Case Management on referral, re-consultation and hospitalization rates of children aged under 5 years in two districts in Northern Malawi: study protocol for a pragmatic, stepped-wedge cluster-randomized controlled trial.

    Science.gov (United States)

    Hardy, Victoria; O'Connor, Yvonne; Heavin, Ciara; Mastellos, Nikolaos; Tran, Tammy; O'Donoghue, John; Fitzpatrick, Annette L; Ide, Nicole; Wu, Tsung-Shu Joseph; Chirambo, Griphin Baxter; Muula, Adamson S; Nyirenda, Moffat; Carlsson, Sven; Andersson, Bo; Thompson, Matthew

    2017-10-11

    There is evidence to suggest that frontline community health workers in Malawi are under-referring children to higher-level facilities. Integrating a digitized version of paper-based methods of Community Case Management (CCM) could strengthen delivery, increasing urgent referral rates and preventing unnecessary re-consultations and hospital admissions. This trial aims to evaluate the added value of the Supporting LIFE electronic Community Case Management Application (SL eCCM App) compared to paper-based CCM on urgent referral, re-consultation and hospitalization rates, in two districts in Northern Malawi. This is a pragmatic, stepped-wedge cluster-randomized trial assessing the added value of the SL eCCM App on urgent referral, re-consultation and hospitalization rates of children aged 2 months and older to up to 5 years, within 7 days of the index visit. One hundred and two health surveillance assistants (HSAs) were stratified into six clusters based on geographical location, and clusters randomized to the timing of crossover to the intervention using simple, computer-generated randomization. Training workshops were conducted prior to the control (paper-CCM) and intervention (paper-CCM + SL eCCM App) in assigned clusters. Neither participants nor study personnel were blinded to allocation. Outcome measures were determined by abstraction of clinical data from patient records 2 weeks after recruitment. A nested qualitative study explored perceptions of adherence to urgent referral recommendations and a cost evaluation determined the financial and time-related costs to caregivers of subsequent health care utilization. The trial was conducted between July 2016 and February 2017. This is the first large-scale trial evaluating the value of adding a mobile application of CCM to the assessment of children aged under 5 years. The trial will generate evidence on the potential use of mobile health for CCM in Malawi, and more widely in other low- and middle

  17. Process evaluation of the Walk Well study: a cluster-randomised controlled trial of a community based walking programme for adults with intellectual disabilities

    Directory of Open Access Journals (Sweden)

    Lynsay Matthews

    2016-07-01

    Full Text Available Abstract Background Walking interventions can be effective in encouraging sedentary populations to become more active; however, limited research has explored the effectiveness of walking interventions for adults with intellectual disabilities. This process evaluation explored the delivery of a community based walking intervention for adults with intellectual disabilities. Methods Walk Well was a single-blind cluster randomised controlled trial of a 12-week physical activity consultation-led walking intervention. 102 participants were randomised to the Walk Well intervention or a waiting list control group. Participants in the intervention group received three physical activity consultations with a walking advisor at baseline, 6 & 12-weeks. They were encouraged to use a pedometer to set goals and monitor their daily step count. Primary outcome was change in daily step count at 12-weeks. Process evaluation measures included qualitative interviews with key stakeholders (n = 6 and quantifiable data collected as part of the intervention. Additional process data were extracted from a sub-set of qualitative interviews with participants and carers (n = 20. Data were analysed for process information related to context, recruitment and retention, reach, implementation, and fidelity. Results Walk Well was not effective in significantly increasing levels of physical activity. The process evaluation did, however, highlight several important areas for consideration in future studies, including: a successful recruitment and retention strategy reaching a representative sample of adults with intellectual disabilities in the community; feasible and (for most enjoyable methods of engaging adults with intellectual disabilities in activities to support behaviour change; potential need for greater intervention duration and frequency of contact; advantages and disadvantages of using pedometers as a behaviour change tool; the need for strategies which engage

  18. Researching effective approaches to cleaning in hospitals: protocol of the REACH study, a multi-site stepped-wedge randomised trial.

    Science.gov (United States)

    Hall, Lisa; Farrington, Alison; Mitchell, Brett G; Barnett, Adrian G; Halton, Kate; Allen, Michelle; Page, Katie; Gardner, Anne; Havers, Sally; Bailey, Emily; Dancer, Stephanie J; Riley, Thomas V; Gericke, Christian A; Paterson, David L; Graves, Nicholas

    2016-03-24

    The Researching Effective Approaches to Cleaning in Hospitals (REACH) study will generate evidence about the effectiveness and cost-effectiveness of a novel cleaning initiative that aims to improve the environmental cleanliness of hospitals. The initiative is an environmental cleaning bundle, with five interdependent, evidence-based components (training, technique, product, audit and communication) implemented with environmental services staff to enhance hospital cleaning practices. The REACH study will use a stepped-wedge randomised controlled design to test the study intervention, an environmental cleaning bundle, in 11 Australian hospitals. All trial hospitals will receive the intervention and act as their own control, with analysis undertaken of the change within each hospital based on data collected in the control and intervention periods. Each site will be randomised to one of the 11 intervention timings with staggered commencement dates in 2016 and an intervention period between 20 and 50 weeks. All sites complete the trial at the same time in 2017. The inclusion criteria allow for a purposive sample of both public and private hospitals that have higher-risk patient populations for healthcare-associated infections (HAIs). The primary outcome (objective one) is the monthly number of Staphylococcus aureus bacteraemias (SABs), Clostridium difficile infections (CDIs) and vancomycin resistant enterococci (VRE) infections, per 10,000 bed days. Secondary outcomes for objective one include the thoroughness of hospital cleaning assessed using fluorescent marker technology, the bio-burden of frequent touch surfaces post cleaning and changes in staff knowledge and attitudes about environmental cleaning. A cost-effectiveness analysis will determine the second key outcome (objective two): the incremental cost-effectiveness ratio from implementation of the cleaning bundle. The study uses the integrated Promoting Action on Research Implementation in Health Services (i

  19. Supporting Policy In health with Research: an Intervention Trial (SPIRIT)—protocol for a stepped wedge trial

    Science.gov (United States)

    2014-01-01

    Introduction Governments in different countries have committed to better use of evidence from research in policy. Although many programmes are directed at assisting agencies to better use research, there have been few tests of the effectiveness of such programmes. This paper describes the protocol for SPIRIT (Supporting Policy In health with Research: an Intervention Trial), a trial designed to test the effectiveness of a multifaceted programme to build organisational capacity for the use of research evidence in policy and programme development. The primary aim is to determine whether SPIRIT results in an increase in the extent to which research and research expertise is sought, appraised, generated and used in the development of specific policy products produced by health policy agencies. Methods and analysis A stepped wedge cluster randomised trial involving six health policy agencies located in Sydney, Australia. Policy agencies are the unit of randomisation and intervention. Agencies were randomly allocated to one of three start dates (steps) to receive the 1-year intervention programme, underpinned by an action framework. The SPIRIT intervention is tailored to suit the interests and needs of each agency and includes audit, feedback and goal setting; a leadership programme; staff training; the opportunity to test systems to assist in the use of research in policies; and exchange with researchers. Outcome measures will be collected at each agency every 6 months for 30 months (starting at the beginning of step 1). Ethics and dissemination Ethics approval was granted by the University of Western Sydney Human Research and Ethics Committee HREC Approval H8855. The findings of this study will be disseminated broadly through peer-reviewed publications and presentations at conferences and used to inform future strategies. PMID:24989620

  20. Community-led trials: Intervention co-design in a cluster randomised controlled trial.

    Science.gov (United States)

    Andersson, Neil

    2017-05-30

    In conventional randomised controlled trials (RCTs), researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control.Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies.A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a "male competence".Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the conventional wisdom about how

  1. Community-led trials: Intervention co-design in a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Neil Andersson

    2017-05-01

    Full Text Available Abstract In conventional randomised controlled trials (RCTs, researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control. Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies. A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a “male competence”. Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the

  2. A cluster randomised controlled trial of a nutrition education intervention in the community.

    Science.gov (United States)

    Madigan, S M; Fleming, P; Wright, M E; Stevenson, M; Macauley, D

    2014-04-01

    Patients with enteral feeding tubes are increasingly managed in their home environment and these patients require support from a range of healthcare professionals. A cluster randomised trial of an educational intervention was undertaken among General Practitioners and nurses both in the community and in nursing home caring for patients recently discharged to primary care. This was a short, duration (nutrition education programme delivered in the work place soon after the patient was discharged from hospital. The primary outcome was an improvement in knowledge immediately after the intervention and the secondary outcome was knowledge at 6 months. Those in the intervention group had improved knowledge, which was significantly greater than those in the control group (P work-based targeted nutrition education programme is effective for improving knowledge among general practitioners and nurses both in the community and in nursing homes. © 2013 The Authors Journal of Human Nutrition and Dietetics © 2013 The British Dietetic Association Ltd.

  3. A multi-faceted workplace intervention targeting low back pain was effective for physical work demands and maladaptive pain behaviours, but not for work ability and sickness absence: Stepped wedge cluster randomised trial.

    Science.gov (United States)

    Rasmussen, Charlotte Diana Nørregaard; Holtermann, Andreas; Jørgensen, Marie Birk; Ørberg, Anders; Mortensen, Ole Steen; Søgaard, Karen

    2016-08-01

    The aims of this study were to test whether a multi-faceted intervention effective for low back pain was effective for physical capacity, work demands, maladaptive pain behaviours, work ability and sickness absence due to low back pain. A stepped wedge cluster randomised, controlled trial with 594 nurses' aides was conducted. The intervention lasted 12 weeks and consisted of physical training (12 sessions), cognitive behavioural training (two sessions) and participatory ergonomics (five sessions). Occupational lifting, fear avoidance, physical exertion, muscle strength, support from management, work ability and sickness absence due to low back pain were measured every 3 months. Before and after the intervention we measured physical capacity, kinesiophobia and need for recovery. Linear mixed models adjusted for baseline values of the outcome were used to estimate the effect. Significant reduction in occupational lifting (-0.35 (95% confidence interval -0.61 to -0.08)), and improvement in two measures of fear avoidance ((-0.75 (95% confidence interval -1.05 to -0.45) and -0.45 (95% confidence interval -0.80 to -0.11)) were found for the intervention group compared to the control. There were no significant effects on physical exertion, muscle strength, support from management, work ability or sickness absence due to low back pain. After the intervention, significant increased physical capacity and improvements in kinesiophobia were found, but no change in need for recovery. CONCLUSIONS THE INTERVENTION WAS SIGNIFICANTLY EFFECTIVE FOR PHYSICAL WORK DEMANDS AND MALADAPTIVE PAIN BEHAVIOURS, BUT NOT FOR WORK ABILITY AND SICKNESS ABSENCE DUE TO LOW BACK PAIN TO IMPROVE WORK ABILITY OR REDUCE SICKNESS ABSENCE DUE TO LOW BACK PAIN MORE SPECIFIC INTERVENTIONS SHOULD PROBABLY BE DEVELOPED. © 2016 the Nordic Societies of Public Health.

  4. Effectiveness of a Geriatric Care Model for frail older adults in primary care: Results from a stepped wedge cluster randomized trial.

    Science.gov (United States)

    Hoogendijk, Emiel O; van der Horst, Henriëtte E; van de Ven, Peter M; Twisk, Jos W R; Deeg, Dorly J H; Frijters, Dinnus H M; van Leeuwen, Karen M; van Campen, Jos P C M; Nijpels, Giel; Jansen, Aaltje P D; van Hout, Hein P J

    2016-03-01

    Primary care-based comprehensive care programs have the potential to improve outcomes in frail older adults. We evaluated the impact of the Geriatric Care Model (GCM) on the quality of life of community-dwelling frail older adults. A 24-month stepped wedge cluster randomized controlled trial was conducted between May 2010 and March 2013 in 35 primary care practices in the Netherlands, and included 1147 frail older adults. The intervention consisted of a geriatric in-home assessment by a practice nurse, followed by a tailored care plan. Reassessment occurred every six months. Nurses worked together with primary care physicians and were supervised and trained by geriatric expert teams. Complex patients were reviewed in multidisciplinary consultations. The primary outcome was quality of life (SF-12). Secondary outcomes were health-related quality of life, functional limitations, self-rated health, psychological wellbeing, social functioning and hospitalizations. Intention-to-treat analyses based on multilevel modeling showed no significant differences between the intervention group and usual care regarding SF-12 and most secondary outcomes. Only for IADL limitations we found a small intervention effect in patients who received the intervention for 18months (B=-0.25, 95%CI=-0.43 to -0.06, p=0.007), but this effect was not statistically significant after correction for multiple comparisons. The GCM did not show beneficial effects on quality of life in frail older adults in primary care, compared to usual care. This study strengthens the idea that comprehensive care programs add very little to usual primary care for this population. The Netherlands National Trial Register NTR2160. Copyright © 2015 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

  5. Social marketing and community mobilisation to reduce underage alcohol consumption in Australia: A cluster randomised community trial.

    Science.gov (United States)

    Rowland, Bosco Charles; Williams, Joanne; Smith, Rachel; Hall, Jessica Kate; Osborn, Amber; Kremer, Peter; Kelly, Adrian B; Leslie, Eva; Patton, George; Mohebbi, Mohammadreza; Toumbourou, John W

    2018-08-01

    In many countries adolescent alcohol use is a major health problem. To supplement national policies, it is important to trial community interventions as a potential strategy to prevent adolescent alcohol use. This study evaluated a multicomponent community intervention that included community mobilisation, social marketing, and the monitoring of alcohol sales to minors. Evaluation was a clustered randomised trial design with 14 intervention and 14 control communities. Prior to randomisation, communities were matched on socioeconomic status and location. Intervention communities were not blinded. 3545 Year 8 students (M = 12 years) were surveyed at baseline from 75 schools; 3377 students were surveyed post intervention in 2013 from 54 schools. It was hypothesised that the primary outcome, individual alcohol consumption in last 30 days, after the intervention would be 15% lower in intervention communities. Secondary outcomes were consumption in the past year and intention not to drink before age 18. The intervention communities showed larger relative reductions compared to the controls in last 30-day consumption and past year (10%), but not significantly different. A significantly lower proportion of participants in the intervention community (63%), compared to the controls (71%), reported intending to drink before 18 years old. Subgroup analysis identified regional and state differences for some secondary measures. Intervention assignment was associated with lower adolescent intention to drink before the age of 18. However, more intensive and longer-term intervention may be required to measure significant differences in behaviour change. ACTRN12612000384853. Rowland B, Toumbourou JW, Osborn A, et al. BMJ Open 2013;3:e002423. doi:10.1136/bmjopen-2012-002423. Copyright © 2018 Elsevier Inc. All rights reserved.

  6. Task shifting of frontline community health workers for cardiovascular risk reduction: design and rationale of a cluster randomised controlled trial (DISHA study) in India.

    Science.gov (United States)

    Jeemon, Panniyammakal; Narayanan, Gitanjali; Kondal, Dimple; Kahol, Kashvi; Bharadwaj, Ashok; Purty, Anil; Negi, Prakash; Ladhani, Sulaiman; Sanghvi, Jyoti; Singh, Kuldeep; Kapoor, Deksha; Sobti, Nidhi; Lall, Dorothy; Manimunda, Sathyaprakash; Dwivedi, Supriya; Toteja, Gurudyal; Prabhakaran, Dorairaj

    2016-03-15

    Effective task-shifting interventions targeted at reducing the global cardiovascular disease (CVD) epidemic in low and middle-income countries (LMICs) are urgently needed. DISHA is a cluster randomised controlled trial conducted across 10 sites (5 in phase 1 and 5 in phase 2) in India in 120 clusters. At each site, 12 clusters were randomly selected from a district. A cluster is defined as a small village with 250-300 households and well defined geographical boundaries. They were then randomly allocated to intervention and control clusters in a 1:1 allocation sequence. If any of the intervention and control clusters were workers (mainly Anganwadi workers and ASHA workers) and a post intervention survey in a representative sample. The study staff had no information on intervention allocation until the completion of the baseline survey. In order to ensure comparability of data across sites, the DISHA study follows a common protocol and manual of operation with standardized measurement techniques. Our study is the largest community based cluster randomised trial in low and middle-income country settings designed to test the effectiveness of 'task shifting' interventions involving frontline health workers for cardiovascular risk reduction. CTRI/2013/10/004049 . Registered 7 October 2013.

  7. Preventing Weight Gain in Women in Rural Communities: A Cluster Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Catherine Lombard

    2016-01-01

    Full Text Available Obesity is reaching epidemic proportions in both developed and developing countries. Even modest weight gain increases the risk for chronic illness, yet evidence-based interventions to prevent weight gain are rare. This trial will determine if a simple low-intensity intervention can prevent weight gain in women compared to general health information.We conducted a 1-yr pragmatic, cluster randomised controlled trial in 41 Australian towns (clusters randomised using a computer-generated randomisation list for intervention (n = 21 or control (n = 20. Women aged 18 to 50 yr were recruited from the general population to receive a 1-yr self-management lifestyle intervention (HeLP-her consisting of one group session, monthly SMS text messages, one phone coaching session, and a program manual, or to a control group receiving one general women's health education session. From October 2012 to April 2014 we studied 649 women, mean age 39.6 yr (+/- SD 6.7 and BMI of 28.8 kg/m(2 (+/- SD 6.9 with the primary outcome weight change between groups at 1 yr. The mean change in the control was +0.44 kg (95% CI -0.09 to 0.97 and in the intervention group -0.48 kg (95% CI -0.99 to 0.03 with an unadjusted between group difference of -0.92 kg (95% CI -1.67 to -0.16 or -0.87 kg (95% CI -1.62 to -0.13 adjusted for baseline values and clustering. Secondary outcomes included improved diet quality and greater self-management behaviours. The intervention appeared to be equally efficacious across all age, BMI, income, and education subgroups. Loss to follow-up included 23.8% in the intervention group and 21.8% in the control group and was within the anticipated range. Limitations include lack of sensitive tools to measure the small changes to energy intake and physical activity. Those who gained weight may have been less inclined to return for 1 yr weight measures.A low intensity lifestyle program can prevent the persistent weight gain observed in women. Key features included

  8. Navigating high-risk surgery: protocol for a multisite, stepped wedge, cluster-randomised trial of a question prompt list intervention to empower older adults to ask questions that inform treatment decisions.

    Science.gov (United States)

    Taylor, Lauren J; Rathouz, Paul J; Berlin, Ana; Brasel, Karen J; Mosenthal, Anne C; Finlayson, Emily; Cooper, Zara; Steffens, Nicole M; Jacobson, Nora; Buffington, Anne; Tucholka, Jennifer L; Zhao, Qianqian; Schwarze, Margaret L

    2017-05-29

    Older patients frequently undergo operations that carry high risk for postoperative complications and death. Poor preoperative communication between patients and surgeons can lead to uninformed decisions and result in unexpected outcomes, conflict between surgeons and patients, and treatment inconsistent with patient preferences. This article describes the protocol for a multisite, cluster-randomised trial that uses a stepped wedge design to test a patient-driven question prompt list (QPL) intervention aimed to improve preoperative decision making and inform postoperative expectations. This Patient-Centered Outcomes Research Institute-funded trial will be conducted at five academic medical centres in the USA. Study participants include surgeons who routinely perform vascular or oncological surgery, their patients and families. We aim to enrol 40 surgeons and 480 patients over 24 months. Patients age 65 or older who see a study-enrolled surgeon to discuss a vascular or oncological problem that could be treated with high-risk surgery will be enrolled at their clinic visit. Together with stakeholders, we developed a QPL intervention addressing preoperative communication needs of patients considering major surgery. Guided by the theories of self-determination and relational autonomy, this intervention is designed to increase patient activation. Patients will receive the QPL brochure and a letter from their surgeon encouraging its use. Using audio recordings of the outpatient surgical consultation, patient and family member questionnaires administered at three time points and retrospective chart review, we will compare the effectiveness of the QPL intervention to usual care with respect to the following primary outcomes: patient engagement in decision making, psychological well-being and post-treatment regret for patients and families, and interpersonal and intrapersonal conflict relating to treatment decisions and treatments received. Approvals have been granted by the

  9. Implementing knowledge into practice for improved neonatal survival; a cluster-randomised, community-based trial in Quang Ninh province, Vietnam

    Directory of Open Access Journals (Sweden)

    Huy Tran Q

    2011-09-01

    Full Text Available Abstract Background Globally, almost 4 million newborns die during the first 4 weeks of life every year. By increased use of evidence-based knowledge in the healthcare system a large proportion of these neonatal deaths could be prevented. But there is a severe lack of knowledge on effective methods for successful implementation of evidence into practice, particularly in low- and middle-income countries. Recent studies have demonstrated promising results with increased survival among both mothers and newborns using community-based approaches. In Vietnam evidence-based guidelines on reproductive health were launched in 2003 and revised in 2009. The overall objective of the current project is to evaluate if a facilitation intervention on the community level, with a problem-solving approach involving local representatives if the healthcare system and the community, results in improvements of neonatal health and survival. Methods/Design The study, which has been given the acronym NeoKIP (Neonatal Health - Knowledge Into Practice, took place in 8 districts composed by 90 communes in a province in northern Vietnam, where neonatal mortality rate was 24/1000 in 2005. A cluster randomised design was used, allocating clusters, as defined as a commune and its correponding Commune Health Center (CHC to either intervention or control arm. The facilitation intervention targeted staff at healthcare centres and key persons in the communes. The facilitator role was performed by lay women (Women's Union representatives using quality improvement techniques to initiate and sustain improvement processes targeting identified problem areas. The intervention has been running over 3 years and data were collected on the facilitation process, healthcare staff knowledge in neonatal care and their behaviour in clinical practice, and reproductive and perinatal health indicators. Primary outcome is neonatal mortality. Discussion The intervention is participatory and dynamic

  10. REFOCUS Trial: protocol for a cluster randomised controlled trial of a pro-recovery intervention within community based mental health teams.

    Science.gov (United States)

    Slade, Mike; Bird, Victoria; Le Boutillier, Clair; Williams, Julie; McCrone, Paul; Leamy, Mary

    2011-11-23

    There is a consensus about the importance of 'recovery' in mental health services, but the evidence base is limited. A two centre, cluster randomised controlled trial. Participants are community-based mental health teams, and service users aged 18-65 years with a primary clinical diagnosis of psychosis. In relation to the REFOCUS Manual researchintorecovery.com/refocus, which describes a 12-month, pro-recovery intervention based on the REFOCUS Model, the objectives are: (1) To establish the effectiveness of the intervention described in the REFOCUS Manual; (2) To validate the REFOCUS Model; (3) To establish and optimise trial parameters for the REFOCUS Manual; and (4) To understand the relationship between clinical outcomes and recovery outcomes. The hypothesis for the main study is that service users in the intervention arm will experience significantly greater increases in measures of personal recovery (as measured by the QPR) compared to service users receiving care from control teams. The hypothesis for the secondary study is that black service users in the intervention arm will experience significantly greater increases in measures of personal recovery (as measured by the QPR) and client satisfaction (as measured by the CSQ) compared to Black service users receiving care from control teams. The intervention comprises treatment as usual plus two components: recovery-promoting relationships and working practices. The control condition is treatment as usual. The primary outcme is the Process of Recovery Questionnaire (QPR). Secondary outcomes are satisfaction, Goal setting - Personal Primary Outcome, hope, well-being, empowerment, and quality of life. Primary outcomes for the secondary study will be QPR and satisfaction. Cost data will be estimated, and clinical outcomes will also be reported (symptomatology, need, social disability, functioning). 29 teams (15 intervention and 14 control) will be randomised. Within each team, 15 services users will be randomly

  11. Cost-Effectiveness of a Chronic Care Model for Frail Older Adults in Primary Care: Economic Evaluation Alongside a Stepped-Wedge Cluster-Randomized Trial.

    Science.gov (United States)

    van Leeuwen, Karen M; Bosmans, Judith E; Jansen, Aaltje P D; Hoogendijk, Emiel O; Muntinga, Maaike E; van Hout, Hein P J; Nijpels, Giel; van der Horst, Henriette E; van Tulder, Maurits W

    2015-12-01

    To evaluate the cost-effectiveness of the Geriatric Care Model (GCM), an integrated care model for frail older adults based on the Chronic Care Model, with that of usual care. Economic evaluation alongside a 24-month stepped-wedge cluster-randomized controlled trial. Primary care (35 practices) in two regions in the Netherlands. Community-dwelling older adults who were frail according to their primary care physicians and the Program on Research for Integrating Services for the Maintenance of Autonomy case-finding tool questionnaire (N = 1,147). The GCM consisted of the following components: a regularly scheduled in-home comprehensive geriatric assessment by a practice nurse followed by a customized care plan, management and training of practice nurses by a geriatric expert team, and coordination of care through community network meetings and multidisciplinary team consultations of individuals with complex care needs. Outcomes were measured every 6 months and included costs from a societal perspective, health-related quality of life (Medical Outcomes Study 12-item Short-Form Survey (SF-12) physical (PCS) and mental component summary (MCS) scales), functional limitations (Katz activities of daily living and instrumental activities of daily living), and quality-adjusted life years based on the EQ-5D. Multilevel regression models adjusted for time and baseline confounders showed no significant differences in costs ($356, 95% confidence interval = -$488-1,134) and outcomes between intervention and usual care phases. Cost-effectiveness acceptability curves showed that, for the SF-12 PCS and MCS, the probability of the intervention being cost-effective was 0.76 if decision-makers are willing to pay $30,000 per point improvement on the SF-12 scales (range 0-100). For all other outcomes the probability of the intervention being cost-effective was low. Because the GCM was not cost-effective compared to usual care after 24 months of follow-up, widespread implementation

  12. Community engagement and integrated health and polio immunisation campaigns in conflict-affected areas of Pakistan: a cluster randomised controlled trial.

    Science.gov (United States)

    Habib, Muhammad Atif; Soofi, Sajid; Cousens, Simon; Anwar, Saeed; Haque, Najib Ul; Ahmed, Imran; Ali, Noshad; Tahir, Rehman; Bhutta, Zulfiqar A

    2017-06-01

    Pakistan faces huge challenges in eradicating polio due to widespread poliovirus transmission and security challenges. Innovative interventions are urgently needed to strengthen community buy-in, to increase the coverage of oral polio vaccine (OPV) and other routine immunisations, and to enhance immunity through the introduction of inactivated polio vaccine (IPV) in combination with OPV. We aimed to evaluate the acceptability and effect on immunisation coverage of an integrated strategy for community engagement and maternal and child health immunisation campaigns in insecure and conflict-affected polio-endemic districts of Pakistan. We did a community-based three-arm cluster randomised trial in healthy children aged 1 month to 5 years that resided within the study sites in three districts of Pakistan at high risk of polio. Clusters were randomly assigned by a computer algorithm using restricted randomisation in blocks of 20 by an external statistician (1:1:1) to receive routine polio programme activities (control, arm A), additional interventions with community outreach and mobilisation using an enhanced communication package and provision of short-term preventive maternal and child health services and routine immunisation (health camps), including OPV (arm B), or all interventions of arm B with additional provision of IPV delivered at the maternal and child health camps (arm C). An independent team conducted surveys at baseline, endline, and after each round of supplementary immunisation activity for acceptability and effect. The primary outcome measures for the study were coverage of OPV, IPV, and routine extended programme on immunisation vaccines and changes in the proportion of unvaccinated and fully vaccinated children. This trial is registered with ClinicalTrials.gov, number NCT01908114. Between June 4, 2013, and May 31, 2014, 387 clusters were randomised (131 to arm A, 127 to arm B, and 129 to arm C). At baseline, 28 760 children younger than 5 years were

  13. Promoting smoking cessation in Pakistani and Bangladeshi men in the UK: pilot cluster randomised controlled trial of trained community outreach workers

    Directory of Open Access Journals (Sweden)

    Barton Pelham

    2011-08-01

    Full Text Available Abstract Background Smoking prevalence is high among Pakistani and Bangladeshi men in the UK, but there are few tailored smoking cessation programmes for Pakistani and Bangladeshi communities. The aim of this study was to pilot a cluster randomised controlled trial comparing the effectiveness of Pakistani and Bangladeshi smoking cessation outreach workers with standard care to improve access to and the success of English smoking cessation services. Methods A pilot cluster randomised controlled trial was conducted in Birmingham, UK. Geographical lower layer super output areas were used to identify natural communities where more than 10% of the population were of Pakistani and Bangladeshi origin. 16 agglomerations of super output areas were randomised to normal care controls vs. outreach intervention. The number of people setting quit dates using NHS services, validated abstinence from smoking at four weeks, and stated abstinence at three and six months were assessed. The impact of the intervention on choice and adherence to treatments, attendance at clinic appointments and patient satisfaction were also assessed. Results We were able to randomise geographical areas and deliver the outreach worker-based services. More Pakistani and Bangladeshi men made quit attempts with NHS services in intervention areas compared with control areas, rate ratio (RR 1.32 (95%CI: 1.03-1.69. There was a small increase in the number of 4-week abstinent smokers in intervention areas (RR 1.30, 95%CI: 0.82-2.06. The proportion of service users attending weekly appointments was lower in intervention areas than control areas. No difference was found between intervention and control areas in choice and adherence to treatments or patient satisfaction with the service. The total cost of the intervention was £124,000; an estimated cost per quality-adjusted life year (QALY gained of £8,500. Conclusions The intervention proved feasible and acceptable. Outreach workers expanded

  14. Group based prenatal care in a low-and high risk population in the Netherlands: a study protocol for a stepped wedge cluster randomized controlled trial.

    Science.gov (United States)

    van Zwicht, Birgit S; Crone, Matty R; van Lith, Jan M M; Rijnders, Marlies E B

    2016-11-15

    CenteringPregnancy (CP) is a multifaceted group based care-model integrated in routine prenatal care, combining health assessment, education, and support. CP has shown some positive results on perinatal outcomes. However, the effects are less obvious when limited to the results of randomized controlled trials: as there are few trials and there is a variation in reported outcomes. Furthermore, former research was mostly conducted in the United States of America and in specific (often high risk) populations. Our study aims to evaluate the effects of CP in the Netherlands in a general population of pregnant women (low and high risk). Furthermore we aim to explore the mechanisms leading to the eventual effects by measuring potential mediating factors. We will perform a stepped wedge cluster randomized controlled trial, in a Western region in the Netherlands. Inclusion criteria are care, women in the intervention period (starting at the randomized time-point) will be offered the choice between individual care or CP. Primary outcomes are maternal and neonatal morbidity, retrieved from a national routine database. Secondary outcomes are health behavior, psychosocial outcomes, satisfaction, health care utilization and process outcomes, collected through self-administered questionnaires, group-evaluations and individual interviews. We will conduct intention-to-treat analyses. Also a per protocol analysis will be performed comparing the three subgroups: control group, CP-participants and non-CP-participants, using multilevel techniques to account for clustering effects. This study contributes to the evidence regarding the effect of CP and gives a first indication of the effect and implementation of CP in both low and high-risk pregnancies in a high-income Western society other than the USA. Also, measuring factors that are hypothesized to mediate the effect of CP will enable to explain the mechanisms that lead to effects on maternal and neonatal outcomes. Dutch Trial

  15. Changing cluster composition in cluster randomised controlled trials: design and analysis considerations

    Science.gov (United States)

    2014-01-01

    Background There are many methodological challenges in the conduct and analysis of cluster randomised controlled trials, but one that has received little attention is that of post-randomisation changes to cluster composition. To illustrate this, we focus on the issue of cluster merging, considering the impact on the design, analysis and interpretation of trial outcomes. Methods We explored the effects of merging clusters on study power using standard methods of power calculation. We assessed the potential impacts on study findings of both homogeneous cluster merges (involving clusters randomised to the same arm of a trial) and heterogeneous merges (involving clusters randomised to different arms of a trial) by simulation. To determine the impact on bias and precision of treatment effect estimates, we applied standard methods of analysis to different populations under analysis. Results Cluster merging produced a systematic reduction in study power. This effect depended on the number of merges and was most pronounced when variability in cluster size was at its greatest. Simulations demonstrate that the impact on analysis was minimal when cluster merges were homogeneous, with impact on study power being balanced by a change in observed intracluster correlation coefficient (ICC). We found a decrease in study power when cluster merges were heterogeneous, and the estimate of treatment effect was attenuated. Conclusions Examples of cluster merges found in previously published reports of cluster randomised trials were typically homogeneous rather than heterogeneous. Simulations demonstrated that trial findings in such cases would be unbiased. However, simulations also showed that any heterogeneous cluster merges would introduce bias that would be hard to quantify, as well as having negative impacts on the precision of estimates obtained. Further methodological development is warranted to better determine how to analyse such trials appropriately. Interim recommendations

  16. REFOCUS Trial: protocol for a cluster randomised controlled trial of a pro-recovery intervention within community based mental health teams

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    Slade Mike

    2011-11-01

    Full Text Available Abstract Background There is a consensus about the importance of 'recovery' in mental health services, but the evidence base is limited. Methods/Design A two centre, cluster randomised controlled trial. Participants are community-based mental health teams, and service users aged 18-65 years with a primary clinical diagnosis of psychosis. In relation to the REFOCUS Manual researchintorecovery.com/refocus, which describes a 12-month, pro-recovery intervention based on the REFOCUS Model, the objectives are: (1 To establish the effectiveness of the intervention described in the REFOCUS Manual; (2 To validate the REFOCUS Model; (3 To establish and optimise trial parameters for the REFOCUS Manual; and (4 To understand the relationship between clinical outcomes and recovery outcomes. The hypothesis for the main study is that service users in the intervention arm will experience significantly greater increases in measures of personal recovery (as measured by the QPR compared to service users receiving care from control teams. The hypothesis for the secondary study is that black service users in the intervention arm will experience significantly greater increases in measures of personal recovery (as measured by the QPR and client satisfaction (as measured by the CSQ compared to Black service users receiving care from control teams. The intervention comprises treatment as usual plus two components: recovery-promoting relationships and working practices. The control condition is treatment as usual. The primary outcme is the Process of Recovery Questionnaire (QPR. Secondary outcomes are satisfaction, Goal setting - Personal Primary Outcome, hope, well-being, empowerment, and quality of life. Primary outcomes for the secondary study will be QPR and satisfaction. Cost data will be estimated, and clinical outcomes will also be reported (symptomatology, need, social disability, functioning. 29 teams (15 intervention and 14 control will be randomised. Within

  17. The PULSAR primary care protocol: a stepped-wedge cluster randomized controlled trial to test a training intervention for general practitioners in recovery-oriented practice to optimize personal recovery in adult patients.

    Science.gov (United States)

    Enticott, Joanne C; Shawyer, Frances; Brophy, Lisa; Russell, Grant; Fossey, Ellie; Inder, Brett; Mazza, Danielle; Vasi, Shiva; Weller, Penelope June; Wilson-Evered, Elisabeth; Edan, Vrinda; Meadows, Graham

    2016-12-20

    General practitioners (GPs) in Australia play a central role in the delivery of mental health care. This article describes the PULSAR (Principles Unite Local Services Assisting Recovery) Primary Care protocol, a novel mixed methods evaluation of a training intervention for GPs in recovery-oriented practice. The aim of the intervention is to optimize personal recovery in patients consulting study GPs for mental health issues. The intervention mixed methods design involves a stepped-wedge cluster randomized controlled trial testing the outcomes of training in recovery-oriented practice, together with an embedded qualitative study to identify the contextual enablers and challenges to implementing recovery-oriented practice. The project is conducted in Victoria, Australia between 2013 and 2017. Eighteen general practices and community health centers are randomly allocated to one of two steps (nine months apart) to start an intervention comprising GP training in the delivery of recovery-oriented practice. Data collection consists of cross-sectional surveys collected from patients of participating GPs at baseline, and again at the end of Steps 1 and 2. The primary outcome is improvement in personal recovery using responses to the Questionnaire about the Process of Recovery. Secondary outcomes are improvements in patient-rated measures of personal recovery and wellbeing, and of the recovery-oriented practice they have received, using the INSPIRE questionnaire, the Warwick-Edinburgh Mental Well-being Scale, and the Kessler Psychological Distress Scale. Participant data will be analyzed in the group that the cluster was assigned to at each study time point. Another per-protocol dataset will contain all data time-stamped according to the date of intervention received at each cluster site. Qualitative interviews with GPs and patients at three and nine months post-training will investigate experiences and challenges related to implementing recovery-oriented practice in primary

  18. Sleeping Well Trial: Increasing the effectiveness of treatment with continuous positive airway pressure using a weight management program in overweight adults with obstructive sleep apnoea-A stepped wedge randomised trial protocol.

    Science.gov (United States)

    Truby, Helen; Edwards, Bradley A; O'Driscoll, Denise M; Young, Alan; Ghazi, Ladan; Bristow, Claire; Roem, Kerryn; Bonham, Maxine P; Murgia, Chiara; Day, Kaitlin; Haines, Terry P; Hamilton, Garun S

    2018-05-24

    The majority of adults diagnosed with obstructive sleep apnoea (OSA) are overweight or obese. Continuous positive airway pressure (CPAP) is the most common effective therapy for OSA. However, adherence declines over time with only 50% of patients prescribed CPAP continuing to use it long term. Furthermore, a recent prospective analysis indicated that those more adherent with CPAP therapy have enhanced weight gain trajectories which in turn may negatively impact their OSA. The Sleeping Well Trial aims to establish whether the timing of starting a lifestyle weight loss intervention impacts on weight trajectory in those with moderate-severe OSA treated at home with CPAP, while testing the potential for smart phone technology to improve adherence with lifestyle interventions. A stepped wedge design with randomisation of individuals from 1 to 6 months post-enrolment, with 5 months of additional prospective follow up after completion of the stepped wedge. This design will investigate the effect of the 6-month lifestyle intervention on people undergoing CPAP on body weight, body composition and health-related quality of life. This trial tests whether the timing of supporting the patient through a weight loss intervention is important in obtaining the maximum benefit of a lifestyle change and CPAP usage, and identify how best to support patients through this critical period. The protocol (v1) is registered prospectively with the International Clinical Trials Registry (CTR) ACTRN12616000203459 (public access). Any amendments to protocol will be documented via the CTR. Recruitment commenced in March 2016 with data collection scheduled to finish by May 2018. © 2018 Dietitians Association of Australia.

  19. Use of malaria rapid diagnostic tests by community health workers in Afghanistan: cluster randomised trial.

    Science.gov (United States)

    Leslie, Toby; Rowland, Mark; Mikhail, Amy; Cundill, Bonnie; Willey, Barbara; Alokozai, Asif; Mayan, Ismail; Hasanzai, Anwar; Baktash, Sayed Habibullah; Mohammed, Nader; Wood, Molly; Rahimi, Habib-U-Rahman; Laurent, Baptiste; Buhler, Cyril; Whitty, Christopher J M

    2017-07-07

    The World Health Organisation (WHO) recommends parasitological diagnosis of malaria before treatment, but use of malaria rapid diagnostic tests (mRDTs) by community health workers (CHWs) has not been fully tested within health services in south and central Asia. mRDTs could allow CHWs to diagnose malaria accurately, improving treatment of febrile illness. A cluster randomised trial in community health services was undertaken in Afghanistan. The primary outcome was the proportion of suspected malaria cases correctly treated for polymerase chain reaction (PCR)-confirmed malaria and PCR negative cases receiving no antimalarial drugs measured at the level of the patient. CHWs from 22 clusters (clinics) received standard training on clinical diagnosis and treatment of malaria; 11 clusters randomised to the intervention arm received additional training and were provided with mRDTs. CHWs enrolled cases of suspected malaria, and the mRDT results and treatments were compared to blind-read PCR diagnosis. In total, 256 CHWs enrolled 2400 patients with 2154 (89.8%) evaluated. In the intervention arm, 75.3% (828/1099) were treated appropriately vs. 17.5% (185/1055) in the control arm (cluster adjusted risk ratio: 3.72, 95% confidence interval 2.40-5.77; p < 0.001). In the control arm, 85.9% (164/191) with confirmed Plasmodium vivax received chloroquine compared to 45.1% (70/155) in the intervention arm (p < 0.001). Overuse of chloroquine in the control arm resulted in 87.6% (813/928) of those with no malaria (PCR negative) being treated vs. 10.0% (95/947) in the intervention arm, p < 0.001. In the intervention arm, 71.4% (30/42) of patients with P. falciparum did not receive artemisinin-based combination therapy, partly because operational sensitivity of the RDTs was low (53.2%, 38.1-67.9). There was high concordance between recorded RDT result and CHW prescription decisions: 826/950 (87.0%) with a negative test were not prescribed an antimalarial. Co

  20. Effects of laterally wedged insoles on symptoms and disease progression in medial knee osteoarthritis: a protocol for a randomised, double-blind, placebo controlled trial

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    Osborne Richard

    2007-09-01

    Full Text Available Abstract Background Whilst laterally wedged insoles, worn inside the shoes, are advocated as a simple, inexpensive, non-toxic self-administered intervention for knee osteoarthritis (OA, there is currently limited evidence to support their use. The aim of this randomised, double-blind controlled trial is to determine whether laterally wedges insoles lead to greater improvements in knee pain, physical function and health-related quality of life, and slower structural disease progression as well as being more cost-effective, than control flat insoles in people with medial knee OA. Methods/Design Two hundred participants with painful radiographic medial knee OA and varus malalignment will be recruited from the community and randomly allocated to lateral wedge or control insole groups using concealed allocation. Participants will be blinded as to which insole is considered therapeutic. Blinded follow up assessment will be conducted at 12 months after randomisation. The outcome measures are valid and reliable measures recommended for OA clinical trials. Questionnaires will assess changes in pain, physical function and health-related quality-of-life. Magnetic resonance imaging will measure changes in tibial cartilage volume. To evaluate cost-effectiveness, participants will record the use of all health-related treatments in a log-book returned to the assessor on a monthly basis. To test the effect of the intervention using an intention-to-treat analysis, linear regression modelling will be applied adjusting for baseline outcome values and other demographic characteristics. Discussion Results from this trial will contribute to the evidence regarding the effectiveness of laterally wedged insoles for the management of medial knee OA. Trial registration ACTR12605000503628; NCT00415259.

  1. Impact on Prehospital Delay of a Stroke Preparedness Campaign: A SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial).

    Science.gov (United States)

    Denti, Licia; Caminiti, Caterina; Scoditti, Umberto; Zini, Andrea; Malferrari, Giovanni; Zedde, Maria Luisa; Guidetti, Donata; Baratti, Mario; Vaghi, Luca; Montanari, Enrico; Marcomini, Barbara; Riva, Silvia; Iezzi, Elisa; Castellini, Paola; Olivato, Silvia; Barbi, Filippo; Perticaroli, Eva; Monaco, Daniela; Iafelice, Ilaria; Bigliardi, Guido; Vandelli, Laura; Guareschi, Angelica; Artoni, Andrea; Zanferrari, Carla; Schulz, Peter J

    2017-12-01

    Public campaigns to increase stroke preparedness have been tested in different contexts, showing contradictory results. We evaluated the effectiveness of a stroke campaign, designed specifically for the Italian population in reducing prehospital delay. According to an SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial) design, the campaign was launched in 4 provinces in the northern part of the region Emilia Romagna at 3-month intervals in randomized sequence. The units of analysis were the patients admitted to hospital, with stroke and transient ischemic attack, over a time period of 15 months, beginning 3 months before the intervention was launched in the first province to allow for baseline data collection. The proportion of early arrivals (within 2 hours of symptom onset) was the primary outcome. Thrombolysis rate and some behavioral end points were the secondary outcomes. Data were analyzed using a fixed-effect model, adjusting for cluster and time trends. We enrolled 1622 patients, 912 exposed and 710 nonexposed to the campaign. The proportion of early access was nonsignificantly lower in exposed patients (354 [38.8%] versus 315 [44.4%]; adjusted odds ratio, 0.81; 95% confidence interval, 0.60-1.08; P =0.15). As for secondary end points, an increase was found for stroke recognition, which approximated but did not reach statistical significance ( P =0.07). Our campaign was not effective in reducing prehospital delay. Even if some limitations of the intervention, mainly in terms of duration, are taken into account, our study demonstrates that new communication strategies should be tested before large-scale implementation. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01881152. © 2017 American Heart Association, Inc.

  2. The impact of the carer support needs assessment tool (CSNAT in community palliative care using a stepped wedge cluster trial.

    Directory of Open Access Journals (Sweden)

    Samar M Aoun

    Full Text Available Family caregiving towards the end-of-life entails considerable emotional, social, financial and physical costs for caregivers. Evidence suggests that good support can improve caregiver psychological outcomes. The primary aim of this study was to investigate the impact of using the carer support needs assessment tool (CSNAT, as an intervention to identify and address support needs in end of life home care, on family caregiver outcomes. A stepped wedge design was used to trial the CSNAT intervention in three bases of Silver Chain Hospice Care in Western Australia, 2012-14. The intervention consisted of at least two visits from nurses (2-3 weeks apart to identify, review and address caregivers' needs. The outcome measures for the intervention and control groups were caregiver strain and distress as measured by the Family Appraisal of Caregiving Questionnaire (FACQ-PC, caregiver mental and physical health as measured by SF-12v2, and caregiver workload as measured by extent of caregiver assistance with activities of daily living, at baseline and follow up. Total recruitment was 620. There was 45% attrition for each group between baseline and follow-up mainly due to patient deaths resulting in 322 caregivers completing the study (233 in the intervention group and 89 in the control group. At follow-up, the intervention group showed significant reduction in caregiver strain relative to controls, p=0.018, d=0.348 (95% CI 0.25 to 0.41. Priority support needs identified by caregivers included knowing what to expect in the future, having time for yourself in the day and dealing with your feelings and worries. Despite the challenges at the clinician, organisational and trial levels, the CSNAT intervention led to an improvement in caregiver strain. Effective implementation of an evidence-informed and caregiver-led tool represents a necessary step towards helping palliative care providers better assess and address caregiver needs, ensuring adequate family

  3. Home-based step training using videogame technology in people with Parkinson's disease: a single-blinded randomised controlled trial.

    Science.gov (United States)

    Song, Jooeun; Paul, Serene S; Caetano, Maria Joana D; Smith, Stuart; Dibble, Leland E; Love, Rachelle; Schoene, Daniel; Menant, Jasmine C; Sherrington, Cathie; Lord, Stephen R; Canning, Colleen G; Allen, Natalie E

    2018-03-01

    To determine whether 12-week home-based exergame step training can improve stepping performance, gait and complementary physical and neuropsychological measures associated with falls in Parkinson's disease. A single-blinded randomised controlled trial. Community (experimental intervention), university laboratory (outcome measures). Sixty community-dwelling people with Parkinson's disease. Home-based step training using videogame technology. The primary outcomes were the choice stepping reaction time test and Functional Gait Assessment. Secondary outcomes included physical and neuropsychological measures associated with falls in Parkinson's disease, number of falls over six months and self-reported mobility and balance. Post intervention, there were no differences between the intervention ( n = 28) and control ( n = 25) groups in the primary or secondary outcomes except for the Timed Up and Go test, where there was a significant difference in favour of the control group ( P = 0.02). Intervention participants reported mobility improvement, whereas control participants reported mobility deterioration-between-group difference on an 11-point scale = 0.9 (95% confidence interval: -1.8 to -0.1, P = 0.03). Interaction effects between intervention and disease severity on physical function measures were observed ( P = 0.01 to P = 0.08) with seemingly positive effects for the low-severity group and potentially negative effects for the high-severity group. Overall, home-based exergame step training was not effective in improving the outcomes assessed. However, the improved physical function in the lower disease severity intervention participants as well as the self-reported improved mobility in the intervention group suggest home-based exergame step training may have benefits for some people with Parkinson's disease.

  4. Physical micro-environment interventions for healthier eating in the workplace: protocol for a stepped wedge randomised controlled pilot trial.

    Science.gov (United States)

    Vasiljevic, Milica; Cartwright, Emma; Pechey, Rachel; Hollands, Gareth J; Couturier, Dominique-Laurent; Jebb, Susan A; Marteau, Theresa M

    2017-01-01

    An estimated one third of energy is consumed in the workplace. The workplace is therefore an important context in which to reduce energy consumption to tackle the high rates of overweight and obesity in the general population. Altering environmental cues for food selection and consumption-physical micro-environment or 'choice architecture' interventions-has the potential to reduce energy intake. The first aim of this pilot trial is to estimate the potential impact upon energy purchased of three such environmental cues (size of portions, packages and tableware; availability of healthier vs. less healthy options; and energy labelling) in workplace cafeterias. A second aim of this pilot trial is to examine the feasibility of recruiting eligible worksites, and identify barriers to the feasibility and acceptability of implementing the interventions in preparation for a larger trial. Eighteen worksite cafeterias in England will be assigned to one of three intervention groups to assess the impact on energy purchased of altering (a) portion, package and tableware size ( n  = 6); (b) availability of healthier options ( n  = 6); and (c) energy (calorie) labelling ( n  = 6). Using a stepped wedge design, sites will implement allocated interventions at different time periods, as randomised. This pilot trial will examine the feasibility of recruiting eligible worksites, and the feasibility and acceptability of implementing the interventions in preparation for a larger trial. In addition, a series of linear mixed models will be used to estimate the impact of each intervention on total energy (calories) purchased per time frame of analysis (daily or weekly) controlling for the total sales/transactions adjusted for calendar time and with random effects for worksite. These analyses will allow an estimate of an effect size of each of the three proposed interventions, which will form the basis of the sample size calculations necessary for a larger trial. ISRCTN52923504.

  5. Local Community Detection Algorithm Based on Minimal Cluster

    Directory of Open Access Journals (Sweden)

    Yong Zhou

    2016-01-01

    Full Text Available In order to discover the structure of local community more effectively, this paper puts forward a new local community detection algorithm based on minimal cluster. Most of the local community detection algorithms begin from one node. The agglomeration ability of a single node must be less than multiple nodes, so the beginning of the community extension of the algorithm in this paper is no longer from the initial node only but from a node cluster containing this initial node and nodes in the cluster are relatively densely connected with each other. The algorithm mainly includes two phases. First it detects the minimal cluster and then finds the local community extended from the minimal cluster. Experimental results show that the quality of the local community detected by our algorithm is much better than other algorithms no matter in real networks or in simulated networks.

  6. Translating Evidence for Low Back Pain Management into a Consumer-Focussed Resource for Use in Community Pharmacies: A Cluster-Randomised Controlled Trial

    Science.gov (United States)

    2013-01-01

    Background This cluster-randomised controlled trial determined the effectiveness of an evidence-based, pamphlet intervention in improving low back pain (LBP)-related beliefs among pharmacy consumers. Methods Thirty five community pharmacies were randomised to three groups: pamphlet+education intervention [n = 11]; pamphlet only intervention [n = 11]; control: usual care [n = 13]. Eligibility requirements for clusters included: community-based pharmacies and proprietor participation consent. Pharmacy consumers (N = 317) aged 18–65 years currently experiencing LBP participated. Intervention group allocation depended on the pharmacy attended. Individual-level outcomes were measured at pre-intervention (T0), at two (T1) and eight (T2) weeks post-intervention and included beliefs about LBP [Back Pain Beliefs Questionnaire (BBQ); Fear Avoidance Beliefs Questionnaire (FABQ)]. Secondary outcomes included pain severity, activity impairment and pamphlet perceived usefulness. Blinding to group allocation included primary investigators, outcome assessors and the statistician. Pharmacy staff and consumers were un-blinded. Results Of 35 pharmacies recruited (317 consumers), no clusters were lost to follow-up. Follow-up was available for n = 24 at 2 weeks only; n = 38 at 8 weeks only; n = 148 at both time points, with n = 148+24+38 = 210 analysed (107 excluded: no follow up). Adjusting for baseline scores demonstrated no significant differences in beliefs (2 or at 8 weeks) between pamphlet (with or without education) versus control, or between ‘pamphlet with’ versus ‘without’ education. Work-related fear (FABQ) was significantly lower in consumers receiving pamphlet (with or without education) versus control (difference −2.3, 95%CI: −4.4 to −0.2). There was no significant difference between “pamphlet with” versus “pamphlet without” groups. Consumers receiving the “pamphlet with” reported greater perceived usefulness

  7. Implementing international osteoarthritis treatment guidelines in primary health care: study protocol for the SAMBA stepped wedge cluster randomized controlled trial.

    Science.gov (United States)

    Østerås, Nina; van Bodegom-Vos, Leti; Dziedzic, Krysia; Moseng, Tuva; Aas, Eline; Andreassen, Øyvor; Mdala, Ibrahim; Natvig, Bård; Røtterud, Jan Harald; Schjervheim, Unni-Berit; Vlieland, Thea Vliet; Hagen, Kåre Birger

    2015-12-02

    Previous research indicates that people with osteoarthritis (OA) are not receiving the recommended and optimal treatment. Based on international treatment recommendations for hip and knee OA and previous research, the SAMBA model for integrated OA care in Norwegian primary health care has been developed. The model includes physiotherapist (PT) led patient OA education sessions and an exercise programme lasting 8-12 weeks. This study aims to assess the effectiveness, feasibility, and costs of a tailored strategy to implement the SAMBA model. A cluster randomized controlled trial with stepped wedge design including an effect, process, and cost evaluation will be conducted in six municipalities (clusters) in Norway. The municipalities will be randomized for time of crossover from current usual care to the implementation of the SAMBA model by a tailored strategy. The tailored strategy includes interactive workshops for general practitioners (GPs) and PTs in primary care covering the SAMBA model for integrated OA care, educational material, educational outreach visits, feedback, and reminder material. Outcomes will be measured at the patient, GP, and PT levels using self-report, semi-structured interviews, and register based data. The primary outcome measure is patient-reported quality of care (OsteoArthritis Quality Indicator questionnaire) at 6-month follow-up. Secondary outcomes include referrals to PT, imaging, and referrals to the orthopaedic surgeon as well as participants' treatment satisfaction, symptoms, physical activity level, body weight, and self-reported and measured lower limb function. The actual exposure to the tailor made implementation strategy and user experiences will be measured in a process evaluation. In the economic evaluation, the difference in costs of usual OA care and the SAMBA model for integrated OA care will be compared with the difference in health outcomes and reported by the incremental cost-effectiveness ratio (ICER). The results

  8. Camino Verde (The Green Way: evidence-based community mobilisation for dengue control in Nicaragua and Mexico: feasibility study and study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Neil Andersson

    2017-05-01

    Full Text Available Abstract Background Since the Aedes aegypti mosquitoes that transmit dengue virus can breed in clean water, WHO-endorsed vector control strategies place sachets of organophosphate pesticide, temephos (Abate, in household water storage containers. These and other pesticide-dependent approaches have failed to curb the spread of dengue and multiple dengue virus serotypes continue to spread throughout tropical and subtropical regions worldwide. A feasibility study in Managua, Nicaragua, generated instruments, intervention protocols, training schedules and impact assessment tools for a cluster randomised controlled trial of community-based approaches to vector control comprising an alternative strategy for dengue prevention and control in Nicaragua and Mexico. Methods/Design The Camino Verde (Green Way is a pragmatic parallel group trial of pesticide-free dengue vector control, adding effectiveness to the standard government dengue control. A random sample from the most recent census in three coastal regions of Guerrero state in Mexico will generate 90 study clusters and the equivalent sampling frame in Managua, Nicaragua will generate 60 clusters, making a total of 150 clusters each of 137–140 households. After a baseline study, computer-driven randomisation will allocate to intervention one half of the sites, stratified by country, evidence of recent dengue virus infection in children aged 3–9 years and, in Nicaragua, level of community organisation. Following a common evidence-based education protocol, each cluster will develop and implement its own collective interventions including house-to-house visits, school-based programmes and inter-community visits. After 18 months, a follow-up study will compare dengue history, serological evidence of recent dengue virus infection (via measurement of anti-dengue virus antibodies in saliva samples and entomological indices between intervention and control sites. Discussion Our hypothesis is that

  9. Camino Verde (The Green Way): evidence-based community mobilisation for dengue control in Nicaragua and Mexico: feasibility study and study protocol for a randomised controlled trial.

    Science.gov (United States)

    Andersson, Neil; Arostegui, Jorge; Nava-Aguilera, Elizabeth; Harris, Eva; Ledogar, Robert J

    2017-05-30

    Since the Aedes aegypti mosquitoes that transmit dengue virus can breed in clean water, WHO-endorsed vector control strategies place sachets of organophosphate pesticide, temephos (Abate), in household water storage containers. These and other pesticide-dependent approaches have failed to curb the spread of dengue and multiple dengue virus serotypes continue to spread throughout tropical and subtropical regions worldwide. A feasibility study in Managua, Nicaragua, generated instruments, intervention protocols, training schedules and impact assessment tools for a cluster randomised controlled trial of community-based approaches to vector control comprising an alternative strategy for dengue prevention and control in Nicaragua and Mexico. The Camino Verde (Green Way) is a pragmatic parallel group trial of pesticide-free dengue vector control, adding effectiveness to the standard government dengue control. A random sample from the most recent census in three coastal regions of Guerrero state in Mexico will generate 90 study clusters and the equivalent sampling frame in Managua, Nicaragua will generate 60 clusters, making a total of 150 clusters each of 137-140 households. After a baseline study, computer-driven randomisation will allocate to intervention one half of the sites, stratified by country, evidence of recent dengue virus infection in children aged 3-9 years and, in Nicaragua, level of community organisation. Following a common evidence-based education protocol, each cluster will develop and implement its own collective interventions including house-to-house visits, school-based programmes and inter-community visits. After 18 months, a follow-up study will compare dengue history, serological evidence of recent dengue virus infection (via measurement of anti-dengue virus antibodies in saliva samples) and entomological indices between intervention and control sites. Our hypothesis is that informed community mobilisation adds effectiveness in controlling

  10. Application of a nonrandomized stepped wedge design to evaluate an evidence-based quality improvement intervention: a proof of concept using simulated data on patient-centered medical homes.

    Science.gov (United States)

    Huynh, Alexis K; Lee, Martin L; Farmer, Melissa M; Rubenstein, Lisa V

    2016-10-21

    Stepped wedge designs have gained recognition as a method for rigorously assessing implementation of evidence-based quality improvement interventions (QIIs) across multiple healthcare sites. In theory, this design uses random assignment of sites to successive QII implementation start dates based on a timeline determined by evaluators. However, in practice, QII timing is often controlled more by site readiness. We propose an alternate version of the stepped wedge design that does not assume the randomized timing of implementation while retaining the method's analytic advantages and applying to a broader set of evaluations. To test the feasibility of a nonrandomized stepped wedge design, we developed simulated data on patient care experiences and on QII implementation that had the structures and features of the expected data from a planned QII. We then applied the design in anticipation of performing an actual QII evaluation. We used simulated data on 108,000 patients to model nonrandomized stepped wedge results from QII implementation across nine primary care sites over 12 quarters. The outcome we simulated was change in a single self-administered question on access to care used by Veterans Health Administration (VA), based in the United States, as part of its quarterly patient ratings of quality of care. Our main predictors were QII exposure and time. Based on study hypotheses, we assigned values of 4 to 11 % for improvement in access when sites were first exposed to implementation and 1 to 3 % improvement in each ensuing time period thereafter when sites continued with implementation. We included site-level (practice size) and respondent-level (gender, race/ethnicity) characteristics that might account for nonrandomized timing in site implementation of the QII. We analyzed the resulting data as a repeated cross-sectional model using HLM 7 with a three-level hierarchical data structure and an ordinal outcome. Levels in the data structure included patient ratings

  11. The effectiveness of community action in reducing risky alcohol consumption and harm: a cluster randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Anthony Shakeshaft

    2014-03-01

    Full Text Available The World Health Organization, governments, and communities agree that community action is likely to reduce risky alcohol consumption and harm. Despite this agreement, there is little rigorous evidence that community action is effective: of the six randomised trials of community action published to date, all were US-based and focused on young people (rather than the whole community, and their outcomes were limited to self-report or alcohol purchase attempts. The objective of this study was to conduct the first non-US randomised controlled trial (RCT of community action to quantify the effectiveness of this approach in reducing risky alcohol consumption and harms measured using both self-report and routinely collected data.We conducted a cluster RCT comprising 20 communities in Australia that had populations of 5,000-20,000, were at least 100 km from an urban centre (population ≥ 100,000, and were not involved in another community alcohol project. Communities were pair-matched, and one member of each pair was randomly allocated to the experimental group. Thirteen interventions were implemented in the experimental communities from 2005 to 2009: community engagement; general practitioner training in alcohol screening and brief intervention (SBI; feedback to key stakeholders; media campaign; workplace policies/practices training; school-based intervention; general practitioner feedback on their prescribing of alcohol medications; community pharmacy-based SBI; web-based SBI; Aboriginal Community Controlled Health Services support for SBI; Good Sports program for sports clubs; identifying and targeting high-risk weekends; and hospital emergency department-based SBI. Primary outcomes based on routinely collected data were alcohol-related crime, traffic crashes, and hospital inpatient admissions. Routinely collected data for the entire study period (2001-2009 were obtained in 2010. Secondary outcomes based on pre- and post-intervention surveys (n

  12. The effectiveness of community action in reducing risky alcohol consumption and harm: a cluster randomised controlled trial.

    Science.gov (United States)

    Shakeshaft, Anthony; Doran, Christopher; Petrie, Dennis; Breen, Courtney; Havard, Alys; Abudeen, Ansari; Harwood, Elissa; Clifford, Anton; D'Este, Catherine; Gilmour, Stuart; Sanson-Fisher, Rob

    2014-03-01

    The World Health Organization, governments, and communities agree that community action is likely to reduce risky alcohol consumption and harm. Despite this agreement, there is little rigorous evidence that community action is effective: of the six randomised trials of community action published to date, all were US-based and focused on young people (rather than the whole community), and their outcomes were limited to self-report or alcohol purchase attempts. The objective of this study was to conduct the first non-US randomised controlled trial (RCT) of community action to quantify the effectiveness of this approach in reducing risky alcohol consumption and harms measured using both self-report and routinely collected data. We conducted a cluster RCT comprising 20 communities in Australia that had populations of 5,000-20,000, were at least 100 km from an urban centre (population ≥ 100,000), and were not involved in another community alcohol project. Communities were pair-matched, and one member of each pair was randomly allocated to the experimental group. Thirteen interventions were implemented in the experimental communities from 2005 to 2009: community engagement; general practitioner training in alcohol screening and brief intervention (SBI); feedback to key stakeholders; media campaign; workplace policies/practices training; school-based intervention; general practitioner feedback on their prescribing of alcohol medications; community pharmacy-based SBI; web-based SBI; Aboriginal Community Controlled Health Services support for SBI; Good Sports program for sports clubs; identifying and targeting high-risk weekends; and hospital emergency department-based SBI. Primary outcomes based on routinely collected data were alcohol-related crime, traffic crashes, and hospital inpatient admissions. Routinely collected data for the entire study period (2001-2009) were obtained in 2010. Secondary outcomes based on pre- and post-intervention surveys (n = 2,977 and 2

  13. Effectiveness of a community-based educational programme in reducing the cumulative incidence and prevalence of human Taenia solium cysticercosis in Burkina Faso in 2011–14 (EFECAB: a cluster-randomised controlled trial

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    Hélène Carabin, PhD

    2018-04-01

    Full Text Available Summary: Background: The effectiveness of drug-free interventions in controlling human cysticercosis is not well known. We aimed to estimate the effectiveness of a community-based educational intervention in reducing the frequency of human cysticercosis in Burkina Faso. Methods: We did a cluster-randomised controlled trial between 2011 and 2014. 60 eligible villages from three provinces (Boulkiemdé, Sanguié, and Nayala were randomly allocated to the intervention or control group. Villages raising pigs, that were not a regional capital or located on a main road, that were more than 20 km from Ouagadougou or 5 km from one another, were eligible. In each village, 60 participants were asked for blood samples at baseline, 18 months later (before randomisation, and 18 months after randomisation. Villages were block randomised (1:1 by pig-raising department immediately after the pre-randomisation visit. The intervention aimed to improve knowledge of Taenia solium transmission and control through screening and structured discussion of a 52-min movie, and to increase community self-efficacy through a Self-esteem, Associative strengths, Resourcefulness, Action planning, Responsibility (SARAR approach via the Participatory Hygiene and Sanitation Transformation (PHAST model. The primary outcome was active cysticercosis, defined as the presence of circulating antigens detected by use of B158/B60 ELISA. Effectiveness measured at the village level was estimated by use of three Bayesian hierarchical models. This study is registered with ClinicalTrials.gov, number NCT0309339. Findings: Two villages in the same randomisation block were excluded, resulting in a final sample size of 58 villages. Overall, the intervention tended towards a decrease in the cumulative incidence of active cysticercosis from baseline to after randomisation (adjusted cumulative incidence ratio 0·65, 95% Bayesian credible interval [95% CrI] 0·39–1·05 and a decrease in active

  14. The effectiveness of a clinically integrated e-learning course in evidence-based medicine: A cluster randomised controlled trial

    NARCIS (Netherlands)

    Kulier, Regina; Coppus, Sjors F. P. J.; Zamora, Javier; Hadley, Julie; Malick, Sadia; Das, Kausik; Weinbrenner, Susanne; Meyerrose, Berrit; Decsi, Tamas; Horvath, Andrea R.; Nagy, Eva; Emparanza, Jose I.; Arvanitis, Theodoros N.; Burls, Amanda; Cabello, Juan B.; Kaczor, Marcin; Zanrei, Gianni; Pierer, Karen; Stawiarz, Katarzyna; Kunz, Regina; Mol, Ben W. J.; Khan, Khalid S.

    2009-01-01

    ABSTRACT: BACKGROUND: To evaluate the educational effects of a clinically integrated e-learning course for teaching basic evidence-based medicine (EBM) among postgraduates compared to a traditional lecture-based course of equivalent content. METHODS: We conducted a cluster randomised controlled

  15. A community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda (the SASA! Study): study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Abramsky, Tanya; Devries, Karen; Kiss, Ligia; Francisco, Leilani; Nakuti, Janet; Musuya, Tina; Kyegombe, Nambusi; Starmann, Elizabeth; Kaye, Dan; Michau, Lori; Watts, Charlotte

    2012-06-29

    Gender based violence, including violence by an intimate partner, is a major global human rights and public health problem, with important connections with HIV risk. Indeed, the elimination of sexual and gender based violence is a core pillar of HIV prevention for UNAIDS. Integrated strategies to address the gender norms, relations and inequities that underlie both violence against women and HIV/AIDS are needed. However there is limited evidence about the potential impact of different intervention models. This protocol describes the SASA! an evaluation of a community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda. The SASA! STUDY is a pair-matched cluster randomised controlled trial being conducted in eight communities in Kampala. It is designed to assess the community-level impact of the SASA! intervention on the following six primary outcomes: attitudes towards the acceptability of violence against women and the acceptability of a woman refusing sex (among male and female community members); past year experience of physical intimate partner violence and sexual intimate partner violence (among females); community responses to women experiencing violence (among women reporting past year physical/sexual partner violence); and past year concurrency of sexual partners (among males). 1583 women and men (aged 18-49 years) were surveyed in intervention and control communities prior to intervention implementation in 2007/8. A follow-up cross-sectional survey of community members will take place in 2012. The primary analysis will be an adjusted cluster-level intention to treat analysis, comparing outcomes in intervention and control communities at follow-up. Complementary monitoring and evaluation and qualitative research will be used to explore and describe the process of intervention implementation and the pathways through which change is achieved. This is one of few cluster randomised trials globally to assess

  16. A community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda (the SASA! Study): study protocol for a cluster randomised controlled trial

    Science.gov (United States)

    2012-01-01

    Background Gender based violence, including violence by an intimate partner, is a major global human rights and public health problem, with important connections with HIV risk. Indeed, the elimination of sexual and gender based violence is a core pillar of HIV prevention for UNAIDS. Integrated strategies to address the gender norms, relations and inequities that underlie both violence against women and HIV/AIDS are needed. However there is limited evidence about the potential impact of different intervention models. This protocol describes the SASA! Study: an evaluation of a community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda. Methods/Design The SASA! Study is a pair-matched cluster randomised controlled trial being conducted in eight communities in Kampala. It is designed to assess the community-level impact of the SASA! intervention on the following six primary outcomes: attitudes towards the acceptability of violence against women and the acceptability of a woman refusing sex (among male and female community members); past year experience of physical intimate partner violence and sexual intimate partner violence (among females); community responses to women experiencing violence (among women reporting past year physical/sexual partner violence); and past year concurrency of sexual partners (among males). 1583 women and men (aged 18–49 years) were surveyed in intervention and control communities prior to intervention implementation in 2007/8. A follow-up cross-sectional survey of community members will take place in 2012. The primary analysis will be an adjusted cluster-level intention to treat analysis, comparing outcomes in intervention and control communities at follow-up. Complementary monitoring and evaluation and qualitative research will be used to explore and describe the process of intervention implementation and the pathways through which change is achieved. Discussion This is one of few

  17. Effect of a price discount and consumer education strategy on food and beverage purchases in remote Indigenous Australia: a stepped-wedge randomised controlled trial.

    Science.gov (United States)

    Brimblecombe, Julie; Ferguson, Megan; Chatfield, Mark D; Liberato, Selma C; Gunther, Anthony; Ball, Kylie; Moodie, Marj; Miles, Edward; Magnus, Anne; Mhurchu, Cliona Ni; Leach, Amanda Jane; Bailie, Ross

    2017-02-01

    Evidence is mounting that price discounts can be effective in improving diet. This study examined the effectiveness of a 20% price discount on food and drink purchases with and without consumer education in remote Indigenous Australia. A 20% discount on fruit, vegetables, water, and artificially sweetened soft drinks was applied for 24 weeks in 20 communities in remote Indigenous Australia where the community store was managed by the Arnhem Land Progress Aboriginal Corporation (ALPA) or Outback Stores (OBS) in a stepped-wedge randomised trial. Communities were randomly allocated to a fixed framework of five sets of four stratified by store association; ten stores (two in each set) were randomly assigned to receive consumer education. A store from each of the ALPA and OBS store groups (contained in separate opaque envelopes) was selected, and stores in turn continued to be consecutively allocated to the fixed store set framework, starting with the first store slot in the first store set, until all stores had been allocated. The effect of the discount on the weight of fruit and vegetables purchased (the primary endpoint) was assessed using weekly store sales data and mixed models per protocol. We did sensitivity analyses by repeating the analyses with the outliers included and repeating the analyses for the primary outcome measure removing each store one at a time. This trial was registered with Australian New Zealand Clinical Trials Registry, number ACTRN12613000694718. Weekly store sales data on all food and drink products sold in 20 stores were collected from July 1, 2012, to Dec 28, 2014. Price discount alone was associated with a 12·7% (95% CI 4·1-22·1) increase in purchases in grams of fruit and vegetables combined (primary outcome), and a 19·8% (6·2-35·1) increase post discount (after vs before); an effect of 12 g and 18 g per capita per day. Sensitivity analyses did not modify the results for the primary outcome measure. A 20% discount can only increase

  18. Community-based trial of annual versus biannual single-dose ivermectin plus albendazole against Wuchereria bancrofti infection in human and mosquito populations: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    de Souza, Dziedzom K; Ahorlu, Collins S; Adu-Amankwah, Susan; Otchere, Joseph; Mensah, Sedzro K; Larbi, Irene A; Mensah, George E; Biritwum, Nana-Kwadwo; Boakye, Daniel A

    2017-10-02

    The Global Programme for the Elimination of Lymphatic Filariasis (GPELF) has been in operation since the year 2000, with the aim of eliminating the disease by the year 2020, following five to six rounds of effective annual mass drug administration (MDA). The treatment regimen is ivermectin (IVM) in combination with diethylcarbamazine (DEC) or albendazole (ALB). In Ghana, MDA has been undertaken since 2001. While the disease has been eliminated in many areas, transmission has persisted in some implementation units that had experienced 15 or more rounds of MDA. Thus, new intervention strategies could eliminate residual infection in areas of persistent transmission and speed up the lymphatic filariasis (LF)-elimination process. This study, therefore, seeks to test the hypothesis that biannual treatment of LF-endemic communities will accelerate the interruption of LF in areas of persistent transmission. A cluster randomised trial will be implemented in LF-endemic communities in Ghana. The interventions will be yearly or twice-yearly MDA delivered to entire endemic communities. Allocation to study group will be by clusters identified using the prevalence of LF. Clusters will be randomised to one of two groups: receiving either (1) annual treatment with IVM + ALB or (2) annual MDA with IVM + ALB, followed by an additional MDA 6 months later. The primary outcome measure is the prevalence of LF infection, assessed by four cross-sectional surveys. Entomological assessments will also be undertaken to evaluate the transmission intensity of the disease in the study clusters. Costs and cost-effectiveness will be evaluated. Among a random subsample of participants, microfilaria prevalence will be assessed longitudinally. A nested process evaluation, using semi-structured interviews, focus group discussions and a stakeholder analysis, will investigate the community acceptability, feasibility and scale-up of each delivery system. It is expected that this study will add to

  19. Ananke: temporal clustering reveals ecological dynamics of microbial communities

    Directory of Open Access Journals (Sweden)

    Michael W. Hall

    2017-09-01

    Full Text Available Taxonomic markers such as the 16S ribosomal RNA gene are widely used in microbial community analysis. A common first step in marker-gene analysis is grouping genes into clusters to reduce data sets to a more manageable size and potentially mitigate the effects of sequencing error. Instead of clustering based on sequence identity, marker-gene data sets collected over time can be clustered based on temporal correlation to reveal ecologically meaningful associations. We present Ananke, a free and open-source algorithm and software package that complements existing sequence-identity-based clustering approaches by clustering marker-gene data based on time-series profiles and provides interactive visualization of clusters, including highlighting of internal OTU inconsistencies. Ananke is able to cluster distinct temporal patterns from simulations of multiple ecological patterns, such as periodic seasonal dynamics and organism appearances/disappearances. We apply our algorithm to two longitudinal marker gene data sets: faecal communities from the human gut of an individual sampled over one year, and communities from a freshwater lake sampled over eleven years. Within the gut, the segregation of the bacterial community around a food-poisoning event was immediately clear. In the freshwater lake, we found that high sequence identity between marker genes does not guarantee similar temporal dynamics, and Ananke time-series clusters revealed patterns obscured by clustering based on sequence identity or taxonomy. Ananke is free and open-source software available at https://github.com/beiko-lab/ananke.

  20. Community based physiotherapeutic exercise in COPD self-management: a randomised controlled trial.

    NARCIS (Netherlands)

    Effing, T.; Zielhuis, G.A.; Kerstjens, H.; Valk, P. van der; Palen, J.A.M. van der

    2011-01-01

    Little is known about effects of community-based physiotherapeutic exercise programmes incorporated in COPD self-management programmes. In a randomised trial, the effect of such a programme (COPE-active) on exercise capacity and various secondary outcomes including daily activity as a marker of

  1. Community based psysiotherapeutic exercise in COPD self-management: A randomised controlled trial

    NARCIS (Netherlands)

    Effing, T.W.; Zielhuis, Gerhard; Kerstjens, Huib; van der Valk, Paul; van der Palen, Jacobus Adrianus Maria

    2011-01-01

    Little is known about effects of community-based physiotherapeutic exercise programmes incorporated in COPD self-management programmes. In a randomised trial, the effect of such a programme (COPE-active) on exercise capacity and various secondary outcomes including daily activity as a marker of

  2. Evaluation of community-level interventions to increase early initiation of antenatal care in pregnancy: protocol for the Community REACH study, a cluster randomised controlled trial with integrated process and economic evaluations.

    Science.gov (United States)

    Sawtell, Mary; Sweeney, Lorna; Wiggins, Meg; Salisbury, Cathryn; Eldridge, Sandra; Greenberg, Lauren; Hunter, Rachael; Kaur, Inderjeet; McCourt, Christine; Hatherall, Bethan; Findlay, Gail; Morris, Joanne; Reading, Sandra; Renton, Adrian; Adekoya, Ruth; Green, Belinda; Harvey, Belinda; Latham, Sarah; Patel, Kanta; Vanlessen, Logan; Harden, Angela

    2018-03-05

    The provision of high-quality maternity services is a priority for reducing inequalities in health outcomes for mothers and infants. Best practice includes women having their initial antenatal appointment within the first trimester of pregnancy in order to provide screening and support for healthy lifestyles, well-being and self-care in pregnancy. Previous research has identified inequalities in access to antenatal care, yet there is little evidence on interventions to improve early initiation of antenatal care. The Community REACH trial will assess the effectiveness and cost-effectiveness of engaging communities in the co-production and delivery of an intervention that addresses this issue. The study design is a matched cluster randomised controlled trial with integrated process and economic evaluations. The unit of randomisation is electoral ward. The intervention will be delivered in 10 wards; 10 comparator wards will have normal practice. The primary outcome is the proportion of pregnant women attending their antenatal booking appointment by the 12th completed week of pregnancy. This and a number of secondary outcomes will be assessed for cohorts of women (n = approximately 1450 per arm) who give birth 2-7 and 8-13 months after intervention delivery completion in the included wards, using routinely collected maternity data. Eight hospitals commissioned to provide maternity services in six NHS trusts in north and east London and Essex have been recruited to the study. These trusts will provide anonymised routine data for randomisation and outcomes analysis. The process evaluation will examine intervention implementation, acceptability, reach and possible causal pathways. The economic evaluation will use a cost-consequences analysis and decision model to evaluate the intervention. Targeted community engagement in the research process was a priority. Community REACH aims to increase early initiation of antenatal care using an intervention that is co-produced and

  3. Bias and inference from misspecified mixed-effect models in stepped wedge trial analysis.

    Science.gov (United States)

    Thompson, Jennifer A; Fielding, Katherine L; Davey, Calum; Aiken, Alexander M; Hargreaves, James R; Hayes, Richard J

    2017-10-15

    Many stepped wedge trials (SWTs) are analysed by using a mixed-effect model with a random intercept and fixed effects for the intervention and time periods (referred to here as the standard model). However, it is not known whether this model is robust to misspecification. We simulated SWTs with three groups of clusters and two time periods; one group received the intervention during the first period and two groups in the second period. We simulated period and intervention effects that were either common-to-all or varied-between clusters. Data were analysed with the standard model or with additional random effects for period effect or intervention effect. In a second simulation study, we explored the weight given to within-cluster comparisons by simulating a larger intervention effect in the group of the trial that experienced both the control and intervention conditions and applying the three analysis models described previously. Across 500 simulations, we computed bias and confidence interval coverage of the estimated intervention effect. We found up to 50% bias in intervention effect estimates when period or intervention effects varied between clusters and were treated as fixed effects in the analysis. All misspecified models showed undercoverage of 95% confidence intervals, particularly the standard model. A large weight was given to within-cluster comparisons in the standard model. In the SWTs simulated here, mixed-effect models were highly sensitive to departures from the model assumptions, which can be explained by the high dependence on within-cluster comparisons. Trialists should consider including a random effect for time period in their SWT analysis model. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.

  4. Assessment of community-level effects of intermittent preventive treatment for malaria in schoolchildren in Jinja, Uganda (START-IPT trial): a cluster-randomised trial.

    Science.gov (United States)

    Staedke, Sarah G; Maiteki-Sebuguzi, Catherine; Rehman, Andrea M; Kigozi, Simon P; Gonahasa, Samuel; Okiring, Jaffer; Lindsay, Steve W; Kamya, Moses R; Chandler, Clare I R; Dorsey, Grant; Drakeley, Chris

    2018-06-01

    Intermittent preventive treatment (IPT) is a well established malaria control intervention. Evidence that delivering IPT to schoolchildren could provide community-level benefits is limited. We did a cluster-randomised controlled trial to assess the effect of IPT of primary schoolchildren with dihydroartemisinin-piperaquine (DP) on indicators of malaria transmission in the community, in Jinja, Uganda. We included 84 clusters, each comprising one primary school and the 100 closest available households. The clusters were randomly assigned 1:1 to receive IPT with DP or standard care (control) by restricted randomisation to ensure balance by geography and school type. Children in intervention schools received IPT monthly for up to six rounds (June to December, 2014). We did cross-sectional community surveys in randomly selected households at baseline and in January to April, 2015, during which we measured participants' temperatures and obtained finger-prick blood smears for measurement of parasite prevalence by microscopy. We also did entomological surveys 1 night per month in households from 20 randomly selected IPT and 20 control clusters. The primary trial outcome was parasite prevalence in the final community survey. The primary entomological survey outcome was the annual entomological inoculation rate (aEIR) from July, 2014, to April, 2015. This trial is registered at ClinicalTrials.gov, number NCT02009215. Among 23 280 students registered in the 42 intervention schools, 10 079 (43%) aged 5-20 years were enrolled and received at least one dose of DP. 9286 (92%) of 10 079 received at least one full course of DP (three doses). Community-level parasite prevalence was lower in the intervention clusters than in the control clusters (19% vs 23%, adjusted risk ratio 0·85, 95% CI 0·73-1·00, p=0·05). The aEIR was lower in the intervention group than in the control group, but not significantly so (10·1 vs 15·2 infective bites per person, adjusted incidence rate

  5. Community mobilisation with women's groups facilitated by Accredited Social Health Activists (ASHAs to improve maternal and newborn health in underserved areas of Jharkhand and Orissa: study protocol for a cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sinha Rajesh

    2011-07-01

    Full Text Available Abstract Background Around a quarter of the world's neonatal and maternal deaths occur in India. Morbidity and mortality are highest in rural areas and among the poorest wealth quintiles. Few interventions to improve maternal and newborn health outcomes with government-mandated community health workers have been rigorously evaluated at scale in this setting. The study aims to assess the impact of a community mobilisation intervention with women's groups facilitated by ASHAs to improve maternal and newborn health outcomes among rural tribal communities of Jharkhand and Orissa. Methods/design The study is a cluster-randomised controlled trial and will be implemented in five districts, three in Jharkhand and two in Orissa. The unit of randomisation is a rural cluster of approximately 5000 population. We identified villages within rural, tribal areas of five districts, approached them for participation in the study and enrolled them into 30 clusters, with approximately 10 ASHAs per cluster. Within each district, 6 clusters were randomly allocated to receive the community intervention or to the control group, resulting in 15 intervention and 15 control clusters. Randomisation was carried out in the presence of local stakeholders who selected the cluster numbers and allocated them to intervention or control using a pre-generated random number sequence. The intervention is a participatory learning and action cycle where ASHAs support community women's groups through a four-phase process in which they identify and prioritise local maternal and newborn health problems, implement strategies to address these and evaluate the result. The cycle is designed to fit with the ASHAs' mandate to mobilise communities for health and to complement their other tasks, including increasing institutional delivery rates and providing home visits to mothers and newborns. The trial's primary endpoint is neonatal mortality during 24 months of intervention. Additional

  6. A community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda (the SASA! Study: study protocol for a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Abramsky Tanya

    2012-06-01

    Full Text Available Abstract Background Gender based violence, including violence by an intimate partner, is a major global human rights and public health problem, with important connections with HIV risk. Indeed, the elimination of sexual and gender based violence is a core pillar of HIV prevention for UNAIDS. Integrated strategies to address the gender norms, relations and inequities that underlie both violence against women and HIV/AIDS are needed. However there is limited evidence about the potential impact of different intervention models. This protocol describes the SASA! Study: an evaluation of a community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda. Methods/Design The SASA! Study is a pair-matched cluster randomised controlled trial being conducted in eight communities in Kampala. It is designed to assess the community-level impact of the SASA! intervention on the following six primary outcomes: attitudes towards the acceptability of violence against women and the acceptability of a woman refusing sex (among male and female community members; past year experience of physical intimate partner violence and sexual intimate partner violence (among females; community responses to women experiencing violence (among women reporting past year physical/sexual partner violence; and past year concurrency of sexual partners (among males. 1583 women and men (aged 18–49 years were surveyed in intervention and control communities prior to intervention implementation in 2007/8. A follow-up cross-sectional survey of community members will take place in 2012. The primary analysis will be an adjusted cluster-level intention to treat analysis, comparing outcomes in intervention and control communities at follow-up. Complementary monitoring and evaluation and qualitative research will be used to explore and describe the process of intervention implementation and the pathways through which change is achieved

  7. Prevention of low back pain and its consequences among nurses’ aides in elderly care: a stepped-wedge multi-faceted cluster-randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background A high prevalence of low back pain has persisted over the years despite extensive primary prevention initiatives among nurses’ aides. Many single-faceted interventions addressing just one aspect of low back pain have been carried out at workplaces, but with low success rate. This may be due to the multi-factorial origin of low back pain. Participatory ergonomics, cognitive behavioral training and physical training have previously shown promising effects on prevention and rehabilitation of low back pain. Therefore, the main aim of this study is to examine whether a multi-faceted workplace intervention consisting of participatory ergonomics, physical training and cognitive behavioral training can prevent low back pain and its consequences among nurses’ aides. External resources for the participating workplace and a strong commitment from the management and the organization support the intervention. Methods/design To overcome implementation barriers within usual randomized controlled trial designed workplace interventions, this study uses a stepped-wedge cluster-randomized controlled trial design with 4 groups. The intervention is delivered to the groups at random along four successive time periods three months apart. The intervention lasts three months and integrates participatory ergonomics, physical training and cognitive behavioral training tailored to the target group. Local physiotherapists and occupational therapists conduct the intervention after having received standardized training. Primary outcomes are low back pain and its consequences measured monthly by text messages up to three months after initiation of the intervention. Discussion Intervention effectiveness trials for preventing low back pain and its consequences in workplaces with physically demanding work are few, primarily single-faceted, with strict adherence to a traditional randomized controlled trial design that may hamper implementation and compliance, and have mostly been

  8. Improving the implementation of perioperative safety guidelines using a multifaceted intervention approach: protocol of the IMPROVE study, a stepped wedge cluster randomized trial.

    Science.gov (United States)

    Emond, Yvette E J J M; Calsbeek, Hiske; Teerenstra, Steven; Bloo, Gerrit J A; Westert, Gert P; Damen, Johan; Wolff, André P; Wollersheim, Hub C

    2015-01-08

    This study is initiated to evaluate the effects, costs, and feasibility at the hospital and patient level of an evidence-based strategy to improve the use of Dutch perioperative safety guidelines. Based on current knowledge, expert opinions and expertise of the project team, a multifaceted implementation strategy has been developed. This is a stepped wedge cluster randomized trial including nine representative hospitals across The Netherlands. Hospitals are stratified into three groups according to hospital type and geographical location and randomized in terms of the period for receipt of the intervention. All adult surgical patients meeting the inclusion criteria are assessed for patient outcomes. The implementation strategy includes education, audit and feedback, organizational interventions (e.g., local embedding of the guidelines), team-directed interventions (e.g., multi-professional team training), reminders, as well as patient-mediated interventions (e.g., patient safety cards). To tailor the implementation activities, we developed a questionnaire to identify barriers for effective guideline adherence, based on (a) a theoretical framework for classifying barriers and facilitators, (b) an instrument for measuring determinants of innovations, and (c) 19 semi-structured interviews with perioperative key professionals. Primary outcome is guideline adherence measured at the hospital (i.e., cluster) and patient levels by a set of perioperative Patient Safety Indicators (PSIs), which was developed parallel to the perioperative guidelines. Secondary outcomes at the patient level are in-hospital complications, postoperative wound infections and mortality, length of hospital stay, and unscheduled transfer to the intensive care unit, non-elective readmission to the hospital and unplanned reoperation, all within 30 days after the initial surgery. Also, patient safety culture and team climate will be studied as potential determinants. Finally, a process evaluation is

  9. Participatory women's groups and counselling through home visits to improve child growth in rural eastern India: protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Nair, Nirmala; Tripathy, Prasanta; Sachdev, Harshpal S; Bhattacharyya, Sanghita; Gope, Rajkumar; Gagrai, Sumitra; Rath, Shibanand; Rath, Suchitra; Sinha, Rajesh; Roy, Swati Sarbani; Shewale, Suhas; Singh, Vijay; Srivastava, Aradhana; Pradhan, Hemanta; Costello, Anthony; Copas, Andrew; Skordis-Worrall, Jolene; Haghparast-Bidgoli, Hassan; Saville, Naomi; Prost, Audrey

    2015-04-15

    Child stunting (low height-for-age) is a marker of chronic undernutrition and predicts children's subsequent physical and cognitive development. Around one third of the world's stunted children live in India. Our study aims to assess the impact, cost-effectiveness, and scalability of a community intervention with a government-proposed community-based worker to improve growth in children under two in rural India. The study is a cluster randomised controlled trial in two rural districts of Jharkhand and Odisha (eastern India). The intervention tested involves a community-based worker carrying out two activities: (a) one home visit to all pregnant women in the third trimester, followed by subsequent monthly home visits to all infants aged 0-24 months to support appropriate feeding, infection control, and care-giving; (b) a monthly women's group meeting using participatory learning and action to catalyse individual and community action for maternal and child health and nutrition. Both intervention and control clusters also receive an intervention to strengthen Village Health Sanitation and Nutrition Committees. The unit of randomisation is a purposively selected cluster of approximately 1000 population. A total of 120 geographical clusters covering an estimated population of 121,531 were randomised to two trial arms: 60 clusters in the intervention arm receive home visits, group meetings, and support to Village Health Sanitation and Nutrition Committees; 60 clusters in the control arm receive support to Committees only. The study participants are pregnant women identified in the third trimester of pregnancy and their children (n = 2520). Mothers and their children are followed up at seven time points: during pregnancy, within 72 hours of delivery, and at 3, 6, 9, 12 and 18 months after birth. The trial's primary outcome is children's mean length-for-age Z scores at 18 months. Secondary outcomes include wasting and underweight at all time points, birth weight, growth

  10. Physical Analysis of Cross-Wedge Rolling Process of a Stepped Shaft

    Directory of Open Access Journals (Sweden)

    Łukasz Wójcik

    2017-12-01

    Full Text Available The paper presents experimental- model research results on the process of cross-wedge rolling of an axially-symmetrical element (stepped shaft. During research was used plastic mass on the basis of waxes in black and white colour. The aim of this experimental research was to determine the best option of forming in terms of values obtained and the course of forces. Physical examination was carried out using specialist machines, that is model and laboratory cross-wedge rolling mill. Experimental analysis was carried out using billets with the temperature of 15°C, whereas the actual process was carried out for billet from C45 carbon steel of temperature 1150°C. The study compared the dimensions of the components obtained during rolling tests and forming forces obtained in the result of physical modeling with forces obtained during real tests.

  11. A stepped strategy that aims at the nationwide implementation of the Enhanced Recovery After Surgery programme in major gynaecological surgery: study protocol of a cluster randomised controlled trial.

    Science.gov (United States)

    de Groot, Jeanny Ja; Maessen, José Mc; Slangen, Brigitte Fm; Winkens, Bjorn; Dirksen, Carmen D; van der Weijden, Trudy

    2015-07-30

    Enhanced Recovery After Surgery (ERAS) programmes aim at an early recovery after surgical trauma and consequently at a reduced length of hospitalisation. This paper presents the protocol for a study that focuses on large-scale implementation of the ERAS programme in major gynaecological surgery in the Netherlands. The trial will evaluate effectiveness and costs of a stepped implementation approach that is characterised by tailoring the intensity of implementation activities to the needs of organisations and local barriers for change, in comparison with the generic breakthrough strategy that is usually applied in large-scale improvement projects in the Netherlands. All Dutch hospitals authorised to perform major abdominal surgery in gynaecological oncology patients are eligible for inclusion in this cluster randomised controlled trial. The hospitals that already fully implemented the ERAS programme in their local perioperative management or those who predominantly admit gynaecological surgery patients to an external hospital replacement care facility will be excluded. Cluster randomisation will be applied at the hospital level and will be stratified based on tertiary status. Hospitals will be randomly assigned to the stepped implementation strategy or the breakthrough strategy. The control group will receive the traditional breakthrough strategy with three educational sessions and the use of plan-do-study-act cycles for planning and executing local improvement activities. The intervention group will receive an innovative stepped strategy comprising four levels of intensity of support. Implementation starts with generic low-cost activities and may build up to the highest level of tailored and labour-intensive activities. The decision for a stepwise increase in intensive support will be based on the success of implementation so far. Both implementation strategies will be completed within 1 year and evaluated on effect, process, and cost-effectiveness. The primary

  12. Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial

    OpenAIRE

    Ayisha Diop, MPH; Bocar Daff, MD; Maimouna Sow, MA; Jennifer Blum, MPH; Mamadou Diagne, PhD; Nancy L Sloan, DrPH; Beverly Winikoff, MD

    2016-01-01

    Background: Access to injectable uterotonics for management of postpartum haemorrhage remains limited in Senegal outside health facilities, and misoprostol and oxytocin delivered via Uniject have been deemed viable alternatives in community settings. We aimed to compare the efficacy of these drugs when delivered by auxiliary midwives at maternity huts. Methods: We did an unmasked cluster-randomised controlled trial at maternity huts in three districts in Senegal. Maternity huts with auxili...

  13. 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

  14. Chevron closing base wedge bunionectomy.

    Science.gov (United States)

    Bruyn, J M

    1993-01-01

    The Chevron-base wedge Association for Osteosynthesis fixated bunionectomy provides a stable, aggressive correction of the severe hallux abducto valgus deformity. It is intended for the bunion requiring a double osteotomy in order to adequately reduce both intermetatarsal and proximal articular facet angle with minimal shortening and elevation. This article presents the rationale for the procedure, technique, and a 4-year follow-up of six patients with eight Chevron-base wedge bunionectomies.

  15. Simulation-based team training for multi-professional obstetric care teams to improve patient outcome : a multicentre, cluster randomised controlled trial

    NARCIS (Netherlands)

    Fransen, A F; van de Ven, J; Schuit, E; van Tetering, Aac; Mol, B W; Oei, S G

    OBJECTIVE: To investigate whether simulation-based obstetric team training in a simulation centre improves patient outcome. DESIGN: Multicentre, open, cluster randomised controlled trial. SETTING: Obstetric units in the Netherlands. POPULATION: Women with a singleton pregnancy beyond 24 weeks of

  16. Randomised and non-randomised studies to estimate the effect of community-level public health interventions: definitions and methodological considerations.

    Science.gov (United States)

    Schmidt, Wolf-Peter

    2017-01-01

    The preferred method to evaluate public health interventions delivered at the level of whole communities is the cluster randomised trial (CRT). The practical limitations of CRTs and the need for alternative methods continue to be debated. There is no consensus on how to classify study designs to evaluate interventions, and how different design features are related to the strength of evidence. This article proposes that most study designs for the evaluation of cluster-level interventions fall into four broad categories: the CRT, the non-randomised cluster trial (NCT), the controlled before-and-after study (CBA), and the before-and-after study without control (BA). A CRT needs to fulfil two basic criteria: (1) the intervention is allocated at random; (2) there are sufficient clusters to allow a statistical between-arm comparison. In a NCT, statistical comparison is made across trial arms as in a CRT, but treatment allocation is not random. The defining feature of a CBA is that intervention and control arms are not compared directly, usually because there are insufficient clusters in each arm to allow a statistical comparison. Rather, baseline and follow-up measures of the outcome of interest are compared in the intervention arm, and separately in the control arm. A BA is a CBA without a control group. Each design may provide useful or misleading evidence. A precise baseline measurement of the outcome of interest is critical for causal inference in all studies except CRTs. Apart from statistical considerations the exploration of pre/post trends in the outcome allows a more transparent discussion of study weaknesses than is possible in non-randomised studies without a baseline measure.

  17. 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

  18. Home visits as part of a new care pathway (iAID) to improve quality of care and quality of life in ostomy patients: a cluster-randomized stepped-wedge trial.

    Science.gov (United States)

    Sier, M F; Oostenbroek, R J; Dijkgraaf, M G W; Veldink, G J; Bemelman, W A; Pronk, A; Spillenaar-Bilgen, E J; Kelder, W; Hoff, C; Ubbink, D T

    2017-08-01

    Morbidity in patients with an ostomy is high. A new care pathway, including perioperative home visits by enterostomal therapists, was studied to assess whether more elaborate education and closer guidance could reduce stoma-related complications and improve quality of life (QoL), at acceptable cost. Patients requiring an ileostomy or colostomy, for any inflammatory or malignant bowel disease, were included in a 15-centre cluster-randomized 'stepped-wedge' study. Primary outcomes were stoma-related complications and QoL, measured using the Stoma-QOL, 3 months after surgery. Secondary outcomes included costs of care. The standard pathway (SP) was followed by 113 patients and the new pathway (NP) by 105 patients. Although the overall number of stoma-related complications was similar in both groups (SP 156, NP 150), the proportion of patients experiencing one or more stoma-related complications was significantly higher in the NP (72% vs 84%, risk difference 12%; 95% CI: 0.3-23.3%). Although in the NP more patients had stoma-related complications, QoL scores were significantly better (P improved quality of care and life, against similar costs. Based on these results the NP, including perioperative home visits by an enterostomal therapist, can be recommended. Colorectal Disease © 2017 The Association of Coloproctology of Great Britain and Ireland.

  19. Steps Towards Alcohol Misuse Prevention Programme (STAMPP): a school-based and community-based cluster randomised controlled trial.

    Science.gov (United States)

    McKay, Michael; Agus, Ashley; Cole, Jonathan; Doherty, Paul; Foxcroft, David; Harvey, Séamus; Murphy, Lynn; Percy, Andrew; Sumnall, Harry

    2018-03-09

    To assess the effectiveness of a combined classroom curriculum and parental intervention (the Steps Towards Alcohol Misuse Prevention Programme (STAMPP)), compared with alcohol education as normal (EAN), in reducing self-reported heavy episodic drinking (HED) and alcohol-related harms (ARHs) in adolescents. 105 high schools in Northern Ireland (NI) and in Scotland. Schools were stratified by free school meal provision. Schools in NI were also stratified by school type (male/female/coeducational). Eligible students were in school year 8/S1 (aged 11-12 years) at baseline (June 2012). A classroom-based alcohol education intervention, coupled with a brief alcohol intervention for parents/carers. PRIMARY OUTCOMES: (1) The prevalence of self-reported HED in the previous 30 days and (2) the number of self-reported ARHs in the previous 6 months. Outcomes were assessed using two-level random intercepts models (logistic regression for HED and negative binomial for number of ARHs). At 33 months, data were available for 5160 intervention and 5073 control students (HED outcome), and 5234 and 5146 students (ARH outcome), respectively. Of those who completed a questionnaire at either baseline or 12 months (n=12 738), 10 405 also completed the questionnaire at 33 months (81.7%). Fewer students in the intervention group reported HED compared with EAN (17%vs26%; OR=0.60, 95% CI 0.49 to 0.73), with no significant difference in the number of self-reported ARHs (incident rate ratio=0.92, 95% CI 0.78 to 1.05). Although the classroom component was largely delivered as intended, there was low uptake of the parental component. There were no reported adverse effects. Results suggest that STAMPP could be an effective programme to reduce HED prevalence. While there was no significant reduction in ARH, it is plausible that effects on harms would manifest later. ISRCTN47028486; Post-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article

  20. A Dimensionality Reduction-Based Multi-Step Clustering Method for Robust Vessel Trajectory Analysis

    Directory of Open Access Journals (Sweden)

    Huanhuan Li

    2017-08-01

    Full Text Available The Shipboard Automatic Identification System (AIS is crucial for navigation safety and maritime surveillance, data mining and pattern analysis of AIS information have attracted considerable attention in terms of both basic research and practical applications. Clustering of spatio-temporal AIS trajectories can be used to identify abnormal patterns and mine customary route data for transportation safety. Thus, the capacities of navigation safety and maritime traffic monitoring could be enhanced correspondingly. However, trajectory clustering is often sensitive to undesirable outliers and is essentially more complex compared with traditional point clustering. To overcome this limitation, a multi-step trajectory clustering method is proposed in this paper for robust AIS trajectory clustering. In particular, the Dynamic Time Warping (DTW, a similarity measurement method, is introduced in the first step to measure the distances between different trajectories. The calculated distances, inversely proportional to the similarities, constitute a distance matrix in the second step. Furthermore, as a widely-used dimensional reduction method, Principal Component Analysis (PCA is exploited to decompose the obtained distance matrix. In particular, the top k principal components with above 95% accumulative contribution rate are extracted by PCA, and the number of the centers k is chosen. The k centers are found by the improved center automatically selection algorithm. In the last step, the improved center clustering algorithm with k clusters is implemented on the distance matrix to achieve the final AIS trajectory clustering results. In order to improve the accuracy of the proposed multi-step clustering algorithm, an automatic algorithm for choosing the k clusters is developed according to the similarity distance. Numerous experiments on realistic AIS trajectory datasets in the bridge area waterway and Mississippi River have been implemented to compare our

  1. A Dimensionality Reduction-Based Multi-Step Clustering Method for Robust Vessel Trajectory Analysis.

    Science.gov (United States)

    Li, Huanhuan; Liu, Jingxian; Liu, Ryan Wen; Xiong, Naixue; Wu, Kefeng; Kim, Tai-Hoon

    2017-08-04

    The Shipboard Automatic Identification System (AIS) is crucial for navigation safety and maritime surveillance, data mining and pattern analysis of AIS information have attracted considerable attention in terms of both basic research and practical applications. Clustering of spatio-temporal AIS trajectories can be used to identify abnormal patterns and mine customary route data for transportation safety. Thus, the capacities of navigation safety and maritime traffic monitoring could be enhanced correspondingly. However, trajectory clustering is often sensitive to undesirable outliers and is essentially more complex compared with traditional point clustering. To overcome this limitation, a multi-step trajectory clustering method is proposed in this paper for robust AIS trajectory clustering. In particular, the Dynamic Time Warping (DTW), a similarity measurement method, is introduced in the first step to measure the distances between different trajectories. The calculated distances, inversely proportional to the similarities, constitute a distance matrix in the second step. Furthermore, as a widely-used dimensional reduction method, Principal Component Analysis (PCA) is exploited to decompose the obtained distance matrix. In particular, the top k principal components with above 95% accumulative contribution rate are extracted by PCA, and the number of the centers k is chosen. The k centers are found by the improved center automatically selection algorithm. In the last step, the improved center clustering algorithm with k clusters is implemented on the distance matrix to achieve the final AIS trajectory clustering results. In order to improve the accuracy of the proposed multi-step clustering algorithm, an automatic algorithm for choosing the k clusters is developed according to the similarity distance. Numerous experiments on realistic AIS trajectory datasets in the bridge area waterway and Mississippi River have been implemented to compare our proposed method with

  2. A multifaceted strategy using mobile technology to assist rural primary healthcare doctors and frontline health workers in cardiovascular disease risk management: protocol for the SMARTHealth India cluster randomised controlled trial.

    Science.gov (United States)

    Praveen, Devarsetty; Patel, Anushka; McMahon, Stephen; Prabhakaran, Dorairaj; Clifford, Gari D; Maulik, Pallab K; Joshi, Rohina; Jan, Stephen; Heritier, Stephane; Peiris, David

    2013-11-25

    Blood Pressure related disease affected 118 million people in India in the year 2000; this figure will double by 2025. Around one in four adults in rural India have hypertension, and of those, only a minority are accessing appropriate care. Health systems in India face substantial challenges to meet these gaps in care, and innovative solutions are needed. We hypothesise that a multifaceted intervention involving capacity strengthening of primary healthcare doctors and non-physician healthcare workers through use of a mobile device-based clinical decision support system will result in improved blood pressure control for individuals at high risk of a cardiovascular disease event when compared with usual healthcare. This intervention will be implemented as a stepped wedge, cluster randomised controlled trial in 18 primary health centres and 54 villages in rural Andhra Pradesh involving adults aged ≥40 years at high cardiovascular disease event risk (approximately 15,000 people). Cardiovascular disease event risk will be calculated based on World Health Organisation/International Society of Hypertension's region-specific risk charts. Cluster randomisation will occur at the level of the primary health centres. Outcome analyses will be conducted blinded to intervention allocation. The primary study outcome is the difference in the proportion of people meeting guideline-recommended blood pressure targets in the intervention period vs. the control period. Secondary outcomes include mean reduction in blood pressure levels; change in other cardiovascular disease risk factors, including body mass index, current smoking, reported healthy eating habits, and reported physical activity levels; self-reported use of blood pressure and other cardiovascular medicines; quality of life (using the EQ-5D); and cardiovascular disease events (using hospitalisation data). Trial outcomes will be accompanied by detailed process and economic evaluations. The findings are likely to inform

  3. Evaluating the effect of innovative motivation and supervision approaches on community health worker performance and retention in Uganda and Mozambique: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Källander, Karin; Strachan, Daniel; Soremekun, Seyi; Hill, Zelee; Lingam, Raghu; Tibenderana, James; Kasteng, Frida; Vassall, Anna; Meek, Sylvia; Kirkwood, Betty

    2015-04-12

    If trained, equipped and utilised, community health workers (CHWs) delivering integrated community case management for sick children can potentially reduce child deaths by 60%. However, it is essential to maintain CHW motivation and performance. The inSCALE project aims to evaluate, using a cluster randomised controlled trial, the effect of interventions to increase CHW supervision and performance on the coverage of appropriate treatment for children with diarrhoea, pneumonia and malaria. Participatory methods were used to identify best practices and innovative solutions. Quantitative community based baseline surveys were conducted to allow restricted randomisation of clusters into intervention and control arms. Individual informed consent was obtained from all respondents. Following formative research and stakeholder consultations, two intervention packages were developed in Uganda and one in Mozambique. In Uganda, approximately 3,500 CHWs in 39 clusters were randomised into a mobile health (mHealth) arm, a participatory community engagement arm and a control arm. In Mozambique, 275 CHWs in 12 clusters were randomised into a mHealth arm and a control arm. The mHealth interventions encompass three components: 1) free phone communication between users; 2) data submission using phones with automated feedback, messages to supervisors for targeted supervision, and online data access for district statisticians; and 3) motivational messages. The community engagement arm in Uganda established village health clubs seeking to 1) improve the status and standing of CHWs, 2) increase demand for health services and 3) communicate that CHWs' work is important. Process evaluation was conducted after 10 months and end-line surveys will establish impact after 12 months in Uganda and 18 months in Mozambique. Main outcomes include proportion of sick children appropriately treated, CHW performance and motivation, and cost effectiveness of interventions. Study strengths include a user

  4. A Hybrid III stepped wedge cluster randomized trial testing an implementation strategy to facilitate the use of an evidence-based practice in VA Homeless Primary Care Treatment Programs.

    Science.gov (United States)

    Simmons, Molly M; Gabrielian, Sonya; Byrne, Thomas; McCullough, Megan B; Smith, Jeffery L; Taylor, Thom J; O'Toole, Tom P; Kane, Vincent; Yakovchenko, Vera; McInnes, D Keith; Smelson, David A

    2017-04-04

    Homeless veterans often have multiple health care and psychosocial needs, including assistance with access to housing and health care, as well as support for ongoing treatment engagement. The Department of Veterans Affairs (VA) developed specialized Homeless Patient Alignment Care Teams (HPACT) with the goal of offering an integrated, "one-stop program" to address housing and health care needs of homeless veterans. However, while 70% of HPACT's veteran enrollees have co-occurring mental health and substance use disorders, HPACT does not have a uniform, embedded treatment protocol for this subpopulation. One wraparound intervention designed to address the needs of homeless veterans with co-occurring mental health and substance use disorders which is suitable to be integrated into HPACT clinic sites is the evidence-based practice called Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Veterans Edition, or MISSION-Vet. Despite the promise of MISSION-Vet within HPACT clinics, implementation of an evidence-based intervention within a busy program like HPACT can be difficult. The current study is being undertaken to identify an appropriate implementation strategy for MISSION-Vet within HPACT. The study will test the implementation platform called Facilitation and compared to implementation as usual (IU). The aims of this study are as follows: (1) Compare the extent to which IU or Facilitation strategies achieve fidelity to the MISSION-Vet intervention as delivered by HPACT homeless provider staff. (2) Compare the effects of Facilitation and IU strategies on the National HPACT Performance Measures. (3) Compare the effects of IU and Facilitation on the permanent housing status. (4) Identify and describe key stakeholders' (patients, providers, staff) experiences with, and perspectives on, the barriers to, and facilitators of implementing MISSION. Type III Hybrid modified stepped wedge implementation comparing IU to Facilitation

  5. Evaluation of a program for routine implementation of shared decision-making in cancer care: study protocol of a stepped wedge cluster randomized trial.

    Science.gov (United States)

    Scholl, Isabelle; Hahlweg, Pola; Lindig, Anja; Bokemeyer, Carsten; Coym, Anja; Hanken, Henning; Müller, Volkmar; Smeets, Ralf; Witzel, Isabell; Kriston, Levente; Härter, Martin

    2018-03-27

    Shared decision-making (SDM) has become increasingly important in health care. However, despite scientific evidence, effective implementation strategies, and a prominent position on the health policy agenda, SDM is not widely implemented in routine practice so far. Therefore, we developed a program for routine implementation of SDM in oncology by conducting an analysis of the current state and a needs assessment in a pilot study based on the Consolidated Framework for Implementation Research (CFIR). Based on these results, the main aim of our current study is to evaluate the process and outcome of this theoretically and empirically grounded multicomponent implementation program designed to foster SDM in routine cancer care. We use a stepped wedge design, a variant of the cluster randomized controlled trial. The intervention to be implemented is SDM. Three participating clinics of one comprehensive cancer center will be randomized and receive the multicomponent SDM implementation program in a time-delayed sequence. The program consists of the following strategies: (a) SDM training for health care professionals, (b) individual coaching for physicians, (c) patient activation strategy, (d) provision of patient information material and decision aids, (e) revision of the clinics' quality management documents, and (f) critical reflection of current organization of multidisciplinary team meetings. We will conduct a mixed methods outcome and process evaluation. The outcome evaluation will consist of four measurement points. The primary outcome is adoption of SDM, measured by the 9-item Shared Decision Making Questionnaire. A range of other implementation outcomes will be assessed (i.e., acceptability, readiness for implementing change, appropriateness, penetration). The implementation process will be evaluated using stakeholder interviews and field notes. This will allow adapting interventions if necessary. This study is the first large study on routine implementation of

  6. A density-based clustering model for community detection in complex networks

    Science.gov (United States)

    Zhao, Xiang; Li, Yantao; Qu, Zehui

    2018-04-01

    Network clustering (or graph partitioning) is an important technique for uncovering the underlying community structures in complex networks, which has been widely applied in various fields including astronomy, bioinformatics, sociology, and bibliometric. In this paper, we propose a density-based clustering model for community detection in complex networks (DCCN). The key idea is to find group centers with a higher density than their neighbors and a relatively large integrated-distance from nodes with higher density. The experimental results indicate that our approach is efficient and effective for community detection of complex networks.

  7. 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.

  8. Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1 trial): study protocol for a pragmatic, stepped-wedge, cluster randomized controlled registry.

    Science.gov (United States)

    Li, Alvin H; Garg, Amit X; Prakash, Versha; Grimshaw, Jeremy M; Taljaard, Monica; Mitchell, Joanna; Matti, Danny; Linklater, Stefanie; Naylor, Kyla L; Dixon, Stephanie; Faulds, Cathy; Bevan, Rachel; Getchell, Leah; Knoll, Greg; Kim, S Joseph; Sontrop, Jessica; Bjerre, Lise M; Tong, Allison; Presseau, Justin

    2017-12-21

    There is a worldwide shortage of organs available for transplant, leading to preventable mortality associated with end-stage organ disease. While most citizens in many countries with an intent-to-donate "opt-in" system support organ donation, registration rates remain low. In Canada, most Canadians support organ donation but less than 25% in most provinces have registered their desire to donate their organs when they die. The family physician office is a promising yet underused setting in which to promote organ donor registration and address known barriers and enablers to registering for deceased organ and tissue donation. We developed a protocol to evaluate an intervention to promote registration for organ and tissue donation in family physician waiting rooms. This protocol describes a planned, stepped-wedge, cluster randomized registry trial in six family physician offices in Ontario, Canada to evaluate the effectiveness of reception staff providing patients with a pamphlet that addresses barriers and enablers to registration including a description of how to register for organ donation. An Internet-enabled tablet will also be provided in waiting rooms so that interested patients can register while waiting for their appointments. Family physicians and reception staff will be provided with training and/or materials to support any conversations about organ donation with their patients. Following a 2-week control period, the six offices will cross sequentially into the intervention arm in randomized sequence at 2-week intervals until all offices deliver the intervention. The primary outcome will be the proportion of patients visiting the office who are registered organ donors 7 days following their office visit. We will evaluate this outcome using routinely collected registry data from provincial administrative databases. A post-trial qualitative evaluation process will assess the experiences of reception staff and family physicians with the intervention and the

  9. Effects of patient safety culture interventions on incident reporting in general practice : A cluster randomised trial a cluster randomised trial

    NARCIS (Netherlands)

    Verbakel, Natasha J.; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M

    2015-01-01

    Background: A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim: To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting: A three-arm cluster randomised trial

  10. Cost and cost-effectiveness of newborn home visits: findings from the Newhints cluster-randomised controlled trial in rural Ghana

    NARCIS (Netherlands)

    Pitt, Catherine; Tawiah, Theresa; Soremekun, Seyi; ten Asbroek, Augustinus H. A.; Manu, Alexander; Tawiah-Agyemang, Charlotte; Hill, Zelee; Owusu-Agyei, Seth; Kirkwood, Betty R.; Hanson, Kara

    2016-01-01

    Every year, 2·9 million newborn babies die worldwide. A meta-analysis of four cluster-randomised controlled trials estimated that home visits by trained community members in programme settings in Ghana and south Asia reduced neonatal mortality by 12% (95% CI 5-18). We aimed to estimate the costs and

  11. Abundance and composition of indigenous bacterial communities in a multi-step biofiltration-based drinking water treatment plant.

    Science.gov (United States)

    Lautenschlager, Karin; Hwang, Chiachi; Ling, Fangqiong; Liu, Wen-Tso; Boon, Nico; Köster, Oliver; Egli, Thomas; Hammes, Frederik

    2014-10-01

    Indigenous bacterial communities are essential for biofiltration processes in drinking water treatment systems. In this study, we examined the microbial community composition and abundance of three different biofilter types (rapid sand, granular activated carbon, and slow sand filters) and their respective effluents in a full-scale, multi-step treatment plant (Zürich, CH). Detailed analysis of organic carbon degradation underpinned biodegradation as the primary function of the biofilter biomass. The biomass was present in concentrations ranging between 2-5 × 10(15) cells/m(3) in all filters but was phylogenetically, enzymatically and metabolically diverse. Based on 16S rRNA gene-based 454 pyrosequencing analysis for microbial community composition, similar microbial taxa (predominantly Proteobacteria, Planctomycetes, Acidobacteria, Bacteriodetes, Nitrospira and Chloroflexi) were present in all biofilters and in their respective effluents, but the ratio of microbial taxa was different in each filter type. This change was also reflected in the cluster analysis, which revealed a change of 50-60% in microbial community composition between the different filter types. This study documents the direct influence of the filter biomass on the microbial community composition of the final drinking water, particularly when the water is distributed without post-disinfection. The results provide new insights on the complexity of indigenous bacteria colonizing drinking water systems, especially in different biofilters of a multi-step treatment plant. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

    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

  13. Supporting recovery in patients with psychosis through care by community-based adult mental health teams (REFOCUS): a multisite, cluster, randomised, controlled trial.

    Science.gov (United States)

    Slade, Mike; Bird, Victoria; Clarke, Eleanor; Le Boutillier, Clair; McCrone, Paul; Macpherson, Rob; Pesola, Francesca; Wallace, Genevieve; Williams, Julie; Leamy, Mary

    2015-06-01

    Mental health policy in many countries is oriented around recovery, but the evidence base for service-level recovery-promotion interventions is lacking. We did a cluster, randomised, controlled trial in two National Health Service Trusts in England. REFOCUS is a 1-year team-level intervention targeting staff behaviour to increase focus on values, preferences, strengths, and goals of patients with psychosis, and staff-patient relationships, through coaching and partnership. Between April, 2011, and May, 2012, community-based adult mental health teams were randomly allocated to provide usual treatment plus REFOCUS or usual treatment alone (control). Baseline and 1-year follow-up outcomes were assessed in randomly selected patients. The primary outcome was recovery and was assessed with the Questionnaire about Processes of Recovery (QPR). We also calculated overall service costs. We used multiple imputation to estimate missing data, and the imputation model captured clustering at the team level. Analysis was by intention to treat. This trial is registered, number ISRCTN02507940. 14 teams were included in the REFOCUS group and 13 in the control group. Outcomes were assessed in 403 patients (88% of the target sample) at baseline and in 297 at 1 year. Mean QPR total scores did not differ between the two groups (REFOCUS group 40·6 [SD 10·1] vs control 40·0 [10·2], adjusted difference 0·68, 95% CI -1·7 to 3·1, p=0·58). High team participation was associated with higher staff-rated scores for recovery-promotion behaviour change (adjusted difference -0·4, 95% CI -0·7 to -0·2, p=0·001) and patient-rated QPR interpersonal scores (-1·6, -2·7 to -0·5, p=0·005) at follow-up than low participation. Patients treated in the REFOCUS group incurred £1062 (95% CI -1103 to 3017) lower adjusted costs than those in the control group. Although the primary endpoint was negative, supporting recovery might, from the staff perspective, improve functioning and reduce needs

  14. Promoting smoking cessation in Bangladeshi and Pakistani male adults: design of a pilot cluster randomised controlled trial of trained community smoking cessation workers

    Directory of Open Access Journals (Sweden)

    Gill Paramjit

    2009-08-01

    Full Text Available Abstract Background The prevalence of smoking is higher among Pakistani and Bangladeshi males than among the general population. Smokers who receive behavioural support and medication quadruple their chances of stopping smoking, but evidence suggests that these populations do not use National Health Service run stop smoking clinics as frequently as would be expected given their high prevalence of smoking. This study aims to tackle some of the main barriers to use of stop smoking services and adherence to treatment programmes by redesigning service delivery to be more acceptable to these adult male populations. The study compares the effectiveness of trained Pakistani and Bangladeshi smoking cessation workers operating in an outreach capacity ('clinic + outreach' with standard care ('clinic only' to improve access to and success of National Health Service smoking cessation services. Methods/design This is a pilot cluster randomised controlled trial based in Birmingham, UK. Super output areas of Birmingham will be identified in which more than 10% of the population are of Pakistani and/or Bangladeshi origin. From these areas, 'natural geographical communities' will be identified. Sixteen aggregated agglomerations of super output areas will be identified, separating areas from each other using buffer regions in order to reduce potential contamination. These natural communities will be randomised to 'clinic + outreach' (intervention or 'clinic only' (control arms. The use of stop smoking services and the numbers of people quitting smoking (defined as prolonged self-reported abstinence at four weeks, three months and six months will be assessed in each area. In addition, we will assess the impact of the intervention on adherence to smoking cessation treatments and patient satisfaction. Trial registration Current Controlled Trials ISRCTN 82127540.

  15. A cluster-randomised controlled trial integrating a community-based water, sanitation and hygiene programme, with mass distribution of albendazole to reduce intestinal parasites in Timor-Leste: the WASH for WORMS research protocol.

    Science.gov (United States)

    Nery, Susana Vaz; McCarthy, James S; Traub, Rebecca; Andrews, Ross M; Black, Jim; Gray, Darren; Weking, Edmund; Atkinson, Jo-An; Campbell, Suzy; Francis, Naomi; Vallely, Andrew; Williams, Gail; Clements, Archie

    2015-12-30

    There is limited evidence demonstrating the benefits of community-based water, sanitation and hygiene (WASH) programmes on infections with soil-transmitted helminths (STH) and intestinal protozoa. Our study aims to contribute to that evidence base by investigating the effectiveness of combining two complementary approaches for control of STH: periodic mass administration of albendazole, and delivery of a community-based WASH programme. WASH for WORMS is a cluster-randomised controlled trial to test the hypothesis that a community-based WASH intervention integrated with periodic mass distribution of albendazole will be more effective in reducing infections with STH and protozoa than mass deworming alone. All 18 participating rural communities in Timor-Leste receive mass chemotherapy every 6 months. Half the communities also receive the community-based WASH programme. Primary outcomes are the cumulative incidence of infection with STH. Secondary outcomes include the prevalence of protozoa; intensity of infection with STH; as well as morbidity indicators (anaemia, stunting and wasting). Each of the trial outcomes will be compared between control and intervention communities. End points will be measured 2 years after the first albendazole distribution; and midpoints are measured at 6 months intervals (12 months for haemoglobin and anthropometric indexes). Mixed-methods research will also be conducted in order to identify barriers and enablers associated with the acceptability and uptake of the WASH programme. Ethics approval was obtained from the human ethics committees at the University of Queensland, Australian National University, Timorese Ministry of Health, and University of Melbourne. The results of the trial will be published in peer-reviewed journals presented at national and international conferences, and disseminated to relevant stakeholders in health and WASH programmes. This study is funded by a Partnership for Better Health--Project grant from the National

  16. A cluster-randomised controlled trial integrating a community-based water, sanitation and hygiene programme, with mass distribution of albendazole to reduce intestinal parasites in Timor-Leste: the WASH for WORMS research protocol

    Science.gov (United States)

    Nery, Susana Vaz; McCarthy, James S; Traub, Rebecca; Andrews, Ross M; Black, Jim; Gray, Darren; Weking, Edmund; Atkinson, Jo-An; Campbell, Suzy; Francis, Naomi; Vallely, Andrew; Williams, Gail; Clements, Archie

    2015-01-01

    Introduction There is limited evidence demonstrating the benefits of community-based water, sanitation and hygiene (WASH) programmes on infections with soil-transmitted helminths (STH) and intestinal protozoa. Our study aims to contribute to that evidence base by investigating the effectiveness of combining two complementary approaches for control of STH: periodic mass administration of albendazole, and delivery of a community-based WASH programme. Methods and analysis WASH for WORMS is a cluster-randomised controlled trial to test the hypothesis that a community-based WASH intervention integrated with periodic mass distribution of albendazole will be more effective in reducing infections with STH and protozoa than mass deworming alone. All 18 participating rural communities in Timor-Leste receive mass chemotherapy every 6 months. Half the communities also receive the community-based WASH programme. Primary outcomes are the cumulative incidence of infection with STH. Secondary outcomes include the prevalence of protozoa; intensity of infection with STH; as well as morbidity indicators (anaemia, stunting and wasting). Each of the trial outcomes will be compared between control and intervention communities. End points will be measured 2 years after the first albendazole distribution; and midpoints are measured at 6 months intervals (12 months for haemoglobin and anthropometric indexes). Mixed-methods research will also be conducted in order to identify barriers and enablers associated with the acceptability and uptake of the WASH programme. Ethics and dissemination Ethics approval was obtained from the human ethics committees at the University of Queensland, Australian National University, Timorese Ministry of Health, and University of Melbourne. The results of the trial will be published in peer-reviewed journals presented at national and international conferences, and disseminated to relevant stakeholders in health and WASH programmes. This study is funded

  17. Stepped-Wedge Cluster Randomized Controlled Trial to Promote Option B+ Retention in Central Mozambique.

    Science.gov (United States)

    Pfeiffer, James T; Napúa, Manuel; Wagenaar, Bradley H; Chale, Falume; Hoek, Roxanne; Micek, Mark; Manuel, João; Michel, Cathy; Cowan, Jessica Greenberg; Cowan, James F; Gimbel, Sarah; Sherr, Kenneth; Gloyd, Stephen; Chapman, Rachel R

    2017-11-01

    This randomized trial studied performance of Option B+ in Mozambique and evaluated an enhanced retention package in public clinics. The study was conducted at 6 clinics in Manica and Sofala Provinces in central Mozambique. Seven hundred sixty-one pregnant women tested HIV+, immediately initiated antiretroviral (ARV) therapy, and were followed to track retention at 6 clinics from May 2014 to May 2015. Clinics were randomly allocated within a stepped-wedge fashion to intervention and control periods. The intervention included (1) workflow modifications and (2) active patient tracking. Retention was defined as percentage of patients returning for 30-, 60-, and 90-day medication refills within 25-35 days of previous refills. During control periods, 52.3% of women returned for 30-day refills vs. 70.8% in intervention periods [odds ratio (OR): 1.80; 95% confidence interval (CI): 1.05 to 3.08]. At 60 days, 46.1% control vs. 57.9% intervention were retained (OR: 1.82; CI: 1.06 to 3.11), and at 90 days, 38.3% control vs. 41.0% intervention (OR: 1.04; CI: 0.60 to 1.82). In prespecified subanalyses, birth before pickups was strongly associated with failure-women giving birth before ARV pickup were 33.3 times (CI: 4.4 to 250.3), 7.5 times (CI: 3.6 to 15.9), and 3.7 times (CI: 2.2 to 6.0) as likely to not return for ARV pickups at 30, 60, and 90 days, respectively. The intervention was effective at 30 and 60 days, but not at 90 days. Combined 90-day retention (40%) and adherence (22.5%) were low. Efforts to improve retention are particularly important for women giving birth before ARV refills.

  18. Effectiveness of structured patient-clinician communication with a solution focused approach (DIALOG+) in community treatment of patients with psychosis--a cluster randomised controlled trial.

    Science.gov (United States)

    Priebe, Stefan; Kelley, Lauren; Golden, Eoin; McCrone, Paul; Kingdon, David; Rutterford, Clare; McCabe, Rosemarie

    2013-06-26

    Large numbers of patients with psychosis have regular meetings with key clinicians in the community. There is little evidence on how these meetings should be conducted to be therapeutically effective. DIALOG, a computer mediated procedure, was shown to improve outcomes in a European multi-centre trial. DIALOG structures the patient-clinician communication and makes it patient-centred, but does not guide clinicians as to how to respond to patients' concerns. DIALOG has been further developed into DIALOG+, which uses advanced software and, additionally, provides a four step approach--based on a solution focused model--for addressing patients' concerns. We designed a cluster randomised controlled trial to test the effectiveness of DIALOG+ in improving treatment outcomes of patients with psychosis in the community. Key workers are recruited from community mental health teams in East London and randomly allocated to either the intervention or control group. Out of their case loads, we identify patients with schizophrenia (F 20-29) and a moderate or lower level of subjective quality of life (MANSA score workers. Key workers in the intervention group are trained in using DIALOG+ and use it with each patient over a six-month period. Control patients rate their satisfaction with life and treatment on a tablet to control for the effect of regular ratings and the use of modern technology. We are recruiting up to 42 key workers to reach a total sample size of 180 patients. Clinical and social outcomes including costs are assessed after 3, 6 and 12 months. Primary outcome is subjective quality-of-life at 6 months. The trial aims to evaluate the effectiveness of a novel intervention (DIALOG+) which uses modern technology to support routine patient-clinician meetings in community care, makes the communication patient centred and guides patients and clinicians to address concerns. DIALOG+ is a generic and widely applicable intervention. If shown as effective, it can be used to

  19. Health coaching and pedometers to enhance physical activity and prevent falls in community-dwelling people aged 60 years and over: study protocol for the Coaching for Healthy AGEing (CHAnGE) cluster randomised controlled trial.

    Science.gov (United States)

    Tiedemann, Anne; Rissel, Chris; Howard, Kirsten; Tong, Allison; Merom, Dafna; Smith, Stuart; Wickham, James; Bauman, Adrian; Lord, Stephen R; Vogler, Constance; Lindley, Richard I; Simpson, Judy M; Allman-Farinelli, Margaret; Sherrington, Catherine

    2016-05-10

    Prevention of falls and promotion of physical activity are essential for maximising well-being in older age. However, there is evidence that promoting physical activity among older people without providing fall prevention advice may increase fall rates. This trial aims to establish the impact of a physical activity and fall prevention programme compared with a healthy eating programme on physical activity and falls among people aged 60+ years. This cluster randomised controlled trial will involve 60 groups of community-dwelling people aged 60+ years. Participating groups will be randomised to: (1) a physical activity and fall prevention intervention (30 groups), involving written information, fall risk assessment and prevention advice, a pedometer-based physical activity tracker and telephone-based health coaching; or (2) a healthy eating intervention (30 groups) involving written information and telephone-based dietary coaching. Primary outcomes will be objectively measured physical activity at 12 months post-randomisation and self-reported falls throughout the 12-month trial period. Secondary outcomes include: the proportion of fallers, the proportion of people meeting the Australian physical activity guidelines, body mass index, eating habits, mobility goal attainment, mobility-related confidence, quality of life, fear of falling, risk-taking behaviour, mood, well-being, self-reported physical activity, disability, and health and community service use. The between-group difference in the number of falls per person-year will be analysed using negative binomial regression models. For the continuously scored primary and secondary outcome measures, linear regression adjusted for corresponding baseline scores will assess the effect of group allocation. Analyses will be preplanned, conducted while masked to group allocation, will take into account cluster randomisation, and will use an intention-to-treat approach. Protocol has been approved by the Human Research

  20. 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.

  1. Effectiveness of a community-based intervention for people with schizophrenia and their caregivers in India (COPSI): a randomised controlled trial.

    Science.gov (United States)

    Chatterjee, Sudipto; Naik, Smita; John, Sujit; Dabholkar, Hamid; Balaji, Madhumitha; Koschorke, Mirja; Varghese, Mathew; Thara, Rangaswamy; Weiss, Helen A; Williams, Paul; McCrone, Paul; Patel, Vikram; Thornicroft, Graham

    2014-04-19

    Observational evidence suggests that community-based services for people with schizophrenia can be successfully provided by community health workers, when supervised by specialists, in low-income and middle-income countries. We did the COmmunity care for People with Schizophrenia in India (COPSI) trial to compare the effectiveness of a collaborative community-based care intervention with standard facility-based care. We did a multicentre, parallel-group, randomised controlled trial at three sites in India between Jan 1, 2009 and Dec 31, 2010. Patients aged 16-60 years with a primary diagnosis of schizophrenia according to the tenth edition of the International Classification of Diseases, Diagnostic Criteria for Research (ICD-10-DCR) were randomly assigned (2:1), via a computer-generated randomisation list with block sizes of three, six, or nine, to receive either collaborative community-based care plus facility-based care or facility-based care alone. Randomisation was stratified by study site. Outcome assessors were masked to group allocation. The primary outcome was a change in symptoms and disabilities over 12 months, as measured by the positive and negative syndrome scale (PANSS) and the Indian disability evaluation and assessment scale (IDEAS). Analysis was by modified intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN 56877013. 187 participants were randomised to the collaborative community-based care plus facility-based care group and 95 were randomised to the facility-based care alone group; 253 (90%) participants completed follow-up to month 12. At 12 months, total PANSS and IDEAS scores were lower in patients in the intervention group than in those in the control group (PANSS adjusted mean difference -3.75, 95% CI -7.92 to 0.42; p=0.08; IDEAS -0.95, -1.68 to -0.23; p=0.01). However, no difference was shown in the proportion of participants who had a reduction of more than 20% in overall

  2. Fluids confined in wedges and by edges: From cluster integrals to thermodynamic properties referred to different regions

    International Nuclear Information System (INIS)

    Urrutia, Ignacio

    2015-01-01

    Recently, new insights into the relation between the geometry of the vessel that confines a fluid and its thermodynamic properties were traced through the study of cluster integrals for inhomogeneous fluids. In this work, I analyze the thermodynamic properties of fluids confined in wedges or by edges, emphasizing on the question of the region to which these properties refer. In this context, the relations between the line-thermodynamic properties referred to different regions are derived as analytic functions of the dihedral angle α, for 0 < α < 2π, which enables a unified approach to both edges and wedges. As a simple application of these results, I analyze the properties of the confined gas in the low-density regime. Finally, using recent analytic results for the second cluster integral of the confined hard sphere fluid, the low density behavior of the line thermodynamic properties is analytically studied up to order two in the density for 0 < α < 2π and by adopting different reference regions

  3. Cardiovascular risk outcome and program evaluation of a cluster randomised controlled trial of a community-based, lay peer led program for people with diabetes

    Directory of Open Access Journals (Sweden)

    M. A. Riddell

    2016-08-01

    Full Text Available Abstract Background The 2013 Global Burden of Disease Study demonstrated the increasing burden of diabetes and the challenge it poses to the health systems of all countries. The chronic and complex nature of diabetes requires active self-management by patients in addition to clinical management in order to achieve optimal glycaemic control and appropriate use of available clinical services. This study is an evaluation of a “real world” peer support program aimed at improving the control and management of type 2 diabetes (T2DM in Australia. Methods The trial used a randomised cluster design with a peer support intervention and routine care control arms and 12-month follow up. Participants in both arms received a standardised session of self-management education at baseline. The intervention program comprised monthly community-based group meetings over 12 months led by trained peer supporters and active encouragement to use primary health care and other community resources and supports related to diabetes. Clinical, behavioural and other measures were collected at baseline, 6 and 12 months. The primary outcome was the predicted 5 year cardiovascular disease risk using the United Kingdom Prospective Diabetes Study (UKPDS Risk Equation at 12 months. Secondary outcomes included clinical measures, quality of life, measures of support, psychosocial functioning and lifestyle measures. Results Eleven of 12 planned groups were successfully implemented in the intervention arm. Both the usual care and the intervention arms demonstrated a small reduction in 5 year UKPDS risk and the mean values for biochemical and anthropometric outcomes were close to target at 12 months. There were some small positive changes in self-management behaviours. Conclusions The positive changes in self-management behaviours among intervention participants were not sufficient to reduce cardiovascular risk, possibly because approximately half of the study participants

  4. A continuous quality improvement intervention to improve the effectiveness of community health workers providing care to mothers and children: a cluster randomised controlled trial in South Africa.

    Science.gov (United States)

    Horwood, Christiane; Butler, Lisa; Barker, Pierre; Phakathi, Sifiso; Haskins, Lyn; Grant, Merridy; Mntambo, Ntokozo; Rollins, Nigel

    2017-06-13

    Community health workers (CHWs) play key roles in delivering health programmes in many countries worldwide. CHW programmes can improve coverage of maternal and child health services for the most disadvantaged and remote communities, leading to substantial benefits for mothers and children. However, there is limited evidence of effective mentoring and supervision approaches for CHWs. This is a cluster randomised controlled trial to investigate the effectiveness of a continuous quality improvement (CQI) intervention amongst CHWs providing home-based education and support to pregnant women and mothers. Thirty CHW supervisors were randomly allocated to intervention (n = 15) and control (n = 15) arms. Four CHWs were randomly selected from those routinely supported by each supervisor (n = 60 per arm). In the intervention arm, these four CHWs and their supervisor formed a quality improvement team. Intervention CHWs received a 2-week training in WHO Community Case Management followed by CQI mentoring for 12 months (preceded by 3 months lead-in to establish QI processes). Baseline and follow-up surveys were conducted with mothers of infants Improved training and CQI-based mentoring of CHWs can improve quantity and quality of CHW-mother interactions at household level, leading to improvements in mothers' knowledge and infant feeding practices. ClinicalTrials.Gov NCT01774136.

  5. Evaluation of community level interventions to address social and structural determinants of health: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Draper Alizon

    2009-06-01

    Full Text Available Abstract Background In London and the rest of the UK, diseases associated with poor diet, inadequate physical activity and mental illness account for a large proportion of area based health inequality. There is a lack of evidence on interventions promoting healthier behaviours especially in marginalised populations, at a structural or ecological level and utilising a community development approach. The Well London project financed by the Big Lottery 'Wellbeing' Fund and implemented by a consortium of London based agencies led by the Greater London Authority and the London Health Commission is implementing a set of complex interventions across 20 deprived areas of London. The interventions focus on healthy eating, healthy physical activity and mental health and wellbeing and are designed and executed with community participation complementing existing facilities and services. Methods/Design The programme will be evaluated through a cluster randomised controlled trial. Forty areas across London were chosen based on deprivation scores. Areas were characterised by high proportion of Black and Minority Ethnic residents, worklessness, ill-health and poor physical environments. Twenty areas were randomly assigned to the intervention arm of Well London project and twenty 'matched' areas assigned as controls. Measures of physical activity, diet and mental health are collected at start and end of the project and compared to assess impact. The quantitative element will be complemented by a longitudinal qualitative study elucidating pathways of influence between intervention activities and health outcomes. A related element of the study investigates the health-related aspects of the structural and ecological characteristics of the project areas. The project 'process' will also be evaluated. Discussion The size of the project and the fact that the interventions are 'complex' in the sense that firstly, there are a number of interacting components with a wide

  6. A cluster randomised controlled trial of advice, exercise or multifactorial assessment to prevent falls and fractures in community-dwelling older adults: protocol for the prevention of falls injury trial (PreFIT).

    Science.gov (United States)

    Bruce, Julie; Lall, Ranjit; Withers, Emma J; Finnegan, Susanne; Underwood, Martin; Hulme, Claire; Sheridan, Ray; Skelton, Dawn A; Martin, Finbarr; Lamb, Sarah E

    2016-01-18

    Falls are the leading cause of accident-related mortality in older adults. Injurious falls are associated with functional decline, disability, healthcare utilisation and significant National Health Service (NHS)-related costs. The evidence base for multifactorial or exercise interventions reducing fractures in the general population is weak. This protocol describes a large-scale UK trial investigating the clinical and cost-effectiveness of alternative falls prevention interventions targeted at community dwelling older adults. A three-arm, pragmatic, cluster randomised controlled trial, conducted within primary care in England, UK. Sixty-three general practices will be randomised to deliver one of three falls prevention interventions: (1) advice only; (2) advice with exercise; or (3) advice with multifactorial falls prevention (MFFP). We aim to recruit over 9000 community-dwelling adults aged 70 and above. Practices randomised to deliver advice will mail out advice booklets. Practices randomised to deliver 'active' interventions, either exercise or MFFP, send all trial participants the advice booklet and a screening survey to identify participants with a history of falling or balance problems. Onward referral to 'active' intervention will be based on falls risk determined from balance screen. The primary outcome is peripheral fracture; secondary outcomes include number with at least one fracture, falls, mortality, quality of life and health service resource use at 18 months, captured using self-report and routine healthcare activity data. The study protocol has approval from the National Research Ethics Service (REC reference 10/H0401/36; Protocol V.3.1, 21/May/2013). User groups and patient representatives were consulted to inform trial design. Results will be reported at conferences and in peer-reviewed publications. A patient-friendly summary of trial findings will be published on the prevention of falls injury trial (PreFIT) website. This protocol adheres to the

  7. Tackling risky alcohol consumption in sport: a cluster randomised controlled trial of an alcohol management intervention with community football clubs.

    Science.gov (United States)

    Kingsland, Melanie; Wolfenden, Luke; Tindall, Jennifer; Rowland, Bosco C; Lecathelinais, Christophe; Gillham, Karen E; Dodds, Pennie; Sidey, Maree N; Rogerson, John C; McElduff, Patrick; Crundall, Ian; Wiggers, John H

    2015-10-01

    An increased prevalence of risky alcohol consumption and alcohol-related harm has been reported for members of sporting groups and at sporting venues compared with non-sporting populations. While sports clubs and venues represent opportune settings to implement strategies to reduce such risks, no controlled trials have been reported. The purpose of the study was to examine the effectiveness of an alcohol management intervention in reducing risky alcohol consumption and the risk of alcohol-related harm among community football club members. A cluster randomised controlled trial of an alcohol management intervention was undertaken with non-elite, community football clubs and their members in New South Wales, Australia. Risky alcohol consumption (5+ drinks) at the club and risk of alcohol-related harm using the Alcohol Use Disorders Identification Test (AUDIT) were measured at baseline and postintervention. Eighty-eight clubs participated in the trial (n=43, INTERVENTION; n=45, CONTROL) and separate cross-sectional samples of club members completed the baseline (N=1411) and postintervention (N=1143) surveys. Postintervention, a significantly lower proportion of intervention club members reported: risky alcohol consumption at the club ( 19%; 24%; OR: 0.63 (95% CI 0.40 to 1.00); p=0.05); risk of alcohol-related harm ( 38%; 45%; OR: 0.58 (95% CI 0.38 to 0.87); psports officiating, enhancing club-based alcohol management interventions could make a substantial contribution to reducing the burden of alcohol misuse in communities. ACTRN12609000224224. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  8. The Boost study: design of a school- and community-based randomised trial to promote fruit and vegetable consumption among teenagers

    Science.gov (United States)

    2012-01-01

    Background The aim of the Boost study was to produce a persistent increase in fruit and vegetable consumption among 13-year-olds. This paper describes the development, implementation and evaluation of a school-and community-based, multi-component intervention guided by theory, evidence, and best practice. Methods/design We used the Intervention Mapping protocol to guide the development of the intervention. Programme activities combined environmental and educational strategies and focused on increasing access to fruit and vegetables in three settings: School: Daily provision of free fruit and vegetables; a pleasant eating environment; classroom curricular activities; individually computer tailored messages; one-day-workshop for teachers. Families: school meeting; guided child-parent activities; newsletters. Local community: guided visits in grocery stores and local area as part of classroom curriculum; information sheets to sports-and youth clubs. The Boost study employed a cluster-randomised controlled study design and applied simple two-stage cluster sampling: A random sample of 10 municipalities followed by a random sample of 4 schools within each municipality (N = 40 schools). Schools were randomised into a total of 20 intervention-and 20 control schools. We included all year 7 pupils except those from school classes with special needs. Timeline: Baseline survey: August 2010. Delivery of intervention: September 2010-May 2011. First follow-up survey: May/June 2011. Second follow-up survey: May/June 2012. Primary outcome measures: Daily mean intake of fruit and vegetables and habitual fruit and vegetable intake measured by validated 24-hour recall-and food frequency questionnaires. Secondary outcome measures: determinants of fruit and vegetable intake, positive side-effects and unintended adverse effects. Implementation was monitored by thorough process evaluation. Discussion The baseline data file included 2,156 adolescents (95%). There was baseline equivalence

  9. Missing continuous outcomes under covariate dependent missingness in cluster randomised trials.

    Science.gov (United States)

    Hossain, Anower; Diaz-Ordaz, Karla; Bartlett, Jonathan W

    2017-06-01

    Attrition is a common occurrence in cluster randomised trials which leads to missing outcome data. Two approaches for analysing such trials are cluster-level analysis and individual-level analysis. This paper compares the performance of unadjusted cluster-level analysis, baseline covariate adjusted cluster-level analysis and linear mixed model analysis, under baseline covariate dependent missingness in continuous outcomes, in terms of bias, average estimated standard error and coverage probability. The methods of complete records analysis and multiple imputation are used to handle the missing outcome data. We considered four scenarios, with the missingness mechanism and baseline covariate effect on outcome either the same or different between intervention groups. We show that both unadjusted cluster-level analysis and baseline covariate adjusted cluster-level analysis give unbiased estimates of the intervention effect only if both intervention groups have the same missingness mechanisms and there is no interaction between baseline covariate and intervention group. Linear mixed model and multiple imputation give unbiased estimates under all four considered scenarios, provided that an interaction of intervention and baseline covariate is included in the model when appropriate. Cluster mean imputation has been proposed as a valid approach for handling missing outcomes in cluster randomised trials. We show that cluster mean imputation only gives unbiased estimates when missingness mechanism is the same between the intervention groups and there is no interaction between baseline covariate and intervention group. Multiple imputation shows overcoverage for small number of clusters in each intervention group.

  10. A systematic review of cluster randomised trials in residential facilities for older people suggests how to improve quality.

    Science.gov (United States)

    Diaz-Ordaz, Karla; Froud, Robert; Sheehan, Bart; Eldridge, Sandra

    2013-10-22

    Previous reviews of cluster randomised trials have been critical of the quality of the trials reviewed, but none has explored determinants of the quality of these trials in a specific field over an extended period of time. Recent work suggests that correct conduct and reporting of these trials may require more than published guidelines. In this review, our aim was to assess the quality of cluster randomised trials conducted in residential facilities for older people, and to determine whether (1) statistician involvement in the trial and (2) strength of journal endorsement of the Consolidated Standards of Reporting Trials (CONSORT) statement influence quality. We systematically identified trials randomising residential facilities for older people, or parts thereof, without language restrictions, up to the end of 2010, using National Library of Medicine (Medline) via PubMed and hand-searching. We based quality assessment criteria largely on the extended CONSORT statement for cluster randomised trials. We assessed statistician involvement based on statistician co-authorship, and strength of journal endorsement of the CONSORT statement from journal websites. 73 trials met our inclusion criteria. Of these, 20 (27%) reported accounting for clustering in sample size calculations and 54 (74%) in the analyses. In 29 trials (40%), methods used to identify/recruit participants were judged by us to have potentially caused bias or reporting was unclear to reach a conclusion. Some elements of quality improved over time but this appeared not to be related to the publication of the extended CONSORT statement for these trials. Trials with statistician/epidemiologist co-authors were more likely to account for clustering in sample size calculations (unadjusted odds ratio 5.4, 95% confidence interval 1.1 to 26.0) and analyses (unadjusted OR 3.2, 1.2 to 8.5). Journal endorsement of the CONSORT statement was not associated with trial quality. Despite international attempts to improve

  11. 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

  12. Protocol for a Cluster Randomised Controlled Trial to Compare the “Taste & See” Programme—A Church-Based Programme to Develop a Healthy Relationship with Food—With a Wait-List Control

    Directory of Open Access Journals (Sweden)

    Deborah Lycett

    2018-03-01

    Full Text Available (1 Background: Obesity is strongly associated with poor mental-health. Spiritual and religious wellbeing is associated with improved mental well-being and reduced emotional eating. “Taste & See”, a church based programme to help develop a healthy relationship with food has been successfully tested for feasibility in the UK but an adequately powered randomised controlled trial is needed to test efficacy. This paper reports on the protocol for such a trial; (2 Method: A cluster, randomised controlled trial where Christian churches (any denomination are the unit of randomisation. 150 overweight adults will be recruited from approximately 15 churches (clusters in the UK, each church (cluster will recruit approximately 10 participants. Churches will be randomised 2:1 to either begin the “Taste & See” programme immediately or in 10 weeks’ time. Data on eating habits, mental and spiritual health will be collected online before and after the intervention and control period and follow-up will continue until 2 years; (3 Implication of Results: Should the programme prove effective it will provide strong clinical evidence of the role of churches in improving the health and well-being of those struggling with food and weight issues.

  13. Increasing physical activity in young primary school children-it's child's play: A cluster randomised controlled trial

    NARCIS (Netherlands)

    Engelen, L.; Bundy, A.C.; Naughton, G.; Simpson, J.M.; Bauman, A.; Ragen, J.; Baur, L.; Wyver, S.; Tranter, P.; Niehues, A.; Schiller, W.; Perry, G.; Jessup, G.; van der Ploeg, H.P.

    2013-01-01

    Objective: To explore the effects of an innovative school-based intervention for increasing physical activity. Methods: 226 children (5-7. years old) randomly selected from 12 Australian primary schools were recruited to a cluster randomised trial with schools randomly allocated to intervention or

  14. 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

    cluster design is the gold standard in implementation research as there would be a high risk of contamination if randomisation was at individual midwife level: community midwives usually work in locality-based teams, interact on a daily basis, and share care of pregnant women. The results of the pilot trial will be used to further develop and refine GLOWING prior to a definitive trial to evaluate effectiveness and cost-effectiveness. ISRCTN46869894; retrospectively registered 25th May 2016.

  15. Interrupting transmission of soil-transmitted helminths: a study protocol for cluster randomised trials evaluating alternative treatment strategies and delivery systems in Kenya.

    Science.gov (United States)

    Brooker, Simon J; Mwandawiro, Charles S; Halliday, Katherine E; Njenga, Sammy M; Mcharo, Carlos; Gichuki, Paul M; Wasunna, Beatrice; Kihara, Jimmy H; Njomo, Doris; Alusala, Dorcas; Chiguzo, Athuman; Turner, Hugo C; Teti, Caroline; Gwayi-Chore, Claire; Nikolay, Birgit; Truscott, James E; Hollingsworth, T Déirdre; Balabanova, Dina; Griffiths, Ulla K; Freeman, Matthew C; Allen, Elizabeth; Pullan, Rachel L; Anderson, Roy M

    2015-10-19

    In recent years, an unprecedented emphasis has been given to the control of neglected tropical diseases, including soil-transmitted helminths (STHs). The mainstay of STH control is school-based deworming (SBD), but mathematical modelling has shown that in all but very low transmission settings, SBD is unlikely to interrupt transmission, and that new treatment strategies are required. This study seeks to answer the question: is it possible to interrupt the transmission of STH, and, if so, what is the most cost-effective treatment strategy and delivery system to achieve this goal? Two cluster randomised trials are being implemented in contrasting settings in Kenya. The interventions are annual mass anthelmintic treatment delivered to preschool- and school-aged children, as part of a national SBD programme, or to entire communities, delivered by community health workers. Allocation to study group is by cluster, using predefined units used in public health provision-termed community units (CUs). CUs are randomised to one of three groups: receiving either (1) annual SBD; (2) annual community-based deworming (CBD); or (3) biannual CBD. The primary outcome measure is the prevalence of hookworm infection, assessed by four cross-sectional surveys. Secondary outcomes are prevalence of Ascaris lumbricoides and Trichuris trichiura, intensity of species infections and treatment coverage. Costs and cost-effectiveness will be evaluated. Among a random subsample of participants, worm burden and proportion of unfertilised eggs will be assessed longitudinally. A nested process evaluation, using semistructured interviews, focus group discussions and a stakeholder analysis, will investigate the community acceptability, feasibility and scale-up of each delivery system. Study protocols have been reviewed and approved by the ethics committees of the Kenya Medical Research Institute and National Ethics Review Committee, and London School of Hygiene and Tropical Medicine. The study has a

  16. Are Pericentric Inversions Reorganizing Wedge Shell Genomes?

    Directory of Open Access Journals (Sweden)

    Daniel García-Souto

    2017-12-01

    Full Text Available Wedge shells belonging to the Donacidae family are the dominant bivalves in exposed beaches in almost all areas of the world. Typically, two or more sympatric species of wedge shells differentially occupy intertidal, sublittoral, and offshore coastal waters in any given locality. A molecular cytogenetic analysis of two sympatric and closely related wedge shell species, Donax trunculus and Donax vittatus, was performed. Results showed that the karyotypes of these two species were both strikingly different and closely alike; whilst metacentric and submetacentric chromosome pairs were the main components of the karyotype of D. trunculus, 10–11 of the 19 chromosome pairs were telocentric in D. vittatus, most likely as a result of different pericentric inversions. GC-rich heterochromatic bands were present in both species. Furthermore, they showed coincidental 45S ribosomal RNA (rRNA, 5S rRNA and H3 histone gene clusters at conserved chromosomal locations, although D. trunculus had an additional 45S rDNA cluster. Intraspecific pericentric inversions were also detected in both D. trunculus and D. vittatus. The close genetic similarity of these two species together with the high degree of conservation of the 45S rRNA, 5S rRNA and H3 histone gene clusters, and GC-rich heterochromatic bands indicate that pericentric inversions contribute to the karyotype divergence in wedge shells.

  17. Improving community ambulation after hip fracture: protocol for a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    D Orwig

    2017-01-01

    Discussion: This multicentre randomised study will be the first to test whether a home-based multi-component physiotherapy intervention targeting specific precursors of community ambulation (PUSH is more likely to lead to community ambulation than a home-based non-specific multi-component physiotherapy intervention (PULSE in older adults after hip fracture. The study will also estimate the potential economic value of the interventions.

  18. Community Clustering Algorithm in Complex Networks Based on Microcommunity Fusion

    Directory of Open Access Journals (Sweden)

    Jin Qi

    2015-01-01

    Full Text Available With the further research on physical meaning and digital features of the community structure in complex networks in recent years, the improvement of effectiveness and efficiency of the community mining algorithms in complex networks has become an important subject in this area. This paper puts forward a concept of the microcommunity and gets final mining results of communities through fusing different microcommunities. This paper starts with the basic definition of the network community and applies Expansion to the microcommunity clustering which provides prerequisites for the microcommunity fusion. The proposed algorithm is more efficient and has higher solution quality compared with other similar algorithms through the analysis of test results based on network data set.

  19. Evaluating the efficacy of the ‘Support for Life’ program for people with dementia and their families and carers’ to enable them to live well: A protocol for a cluster stepped wedge randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dianne Patricia Goeman

    2016-10-01

    Full Text Available Assistance provided to support people living with dementia and carers is highly valued by them. However current support systems in Australia are disjointed, inaccessible to all, poorly co-ordinated and focus on dysfunction rather than ability. Support workers are in short supply and there is little consistency in their roles. To address this large service gap and unmet need we have developed an evidence-based optimised model of holistic support for people with dementia and their carers and families. This article describes the ‘Support for Life’ model intervention. A stepped wedge cluster randomized controlled trial (SWCRCT will be conducted over three years across three Australian states. One hundred participants with dementia and/or their carers/family members will be randomly selected from community health centre client lists in each state to receive either the dementia ‘Support for Life’ intervention (Group A or routine care (Group B. Group A participants will have access to the intervention from year one. Group B participants will continue to receive usual care and will not be denied information on dementia or dementia services in year one. In year two Group B participants will have access to the intervention. A highly trained expert dementia support worker will provide the ‘Support for Life’ intervention, which is a flexible, individually tailored, holistic support that is relationship-centred, focused on enablement as opposed to dysfunction and facilitate participants continued engagement in their community and the workforce. Additionally, dementia education, information resources, advocacy and practical support to navigate and access dementia services and healthcare will be provided. The mode of support will include face to face, telephone and internet, interaction on an ‘as needed basis’ for 12 months. The primary hypothesis is that the intervention will improve the quality of life of people with dementia and the health

  20. Does a pre-hospital emergency pathway improve early diagnosis and referral in suspected stroke patients? – Study protocol of a cluster randomised trial [ISRCTN41456865

    Directory of Open Access Journals (Sweden)

    Lori Giuliano

    2005-10-01

    Full Text Available Abstract Background Early interventions proved to be able to improve prognosis in acute stroke patients. Prompt identification of symptoms, organised timely and efficient transportation towards appropriate facilities, become essential part of effective treatment. The implementation of an evidence based pre-hospital stroke care pathway may be a method for achieving the organizational standards required to grant appropriate care. We performed a systematic search for studies evaluating the effect of pre-hospital and emergency interventions for suspected stroke patients and we found that there seems to be only a few studies on the emergency field and none about implementation of clinical pathways. We will test the hypothesis that the adoption of emergency clinical pathway improves early diagnosis and referral in suspected stroke patients. We designed a cluster randomised controlled trial (C-RCT, the most powerful study design to assess the impact of complex interventions. The study was registered in the Current Controlled Trials Register: ISRCTN41456865 – Implementation of pre-hospital emergency pathway for stroke – a cluster randomised trial. Methods/design Two-arm cluster-randomised trial (C-RCT. 16 emergency services and 14 emergency rooms were randomised either to arm 1 (comprising a training module and administration of the guideline, or to arm 2 (no intervention, current practice. Arm 1 participants (152 physicians, 280 nurses, 50 drivers attended an interactive two sessions course with continuous medical education CME credits on the contents of the clinical pathway. We estimated that around 750 patients will be met by the services in the 6 months of observation. This duration allows recruiting a sample of patients sufficient to observe a 30% improvement in the proportion of appropriate diagnoses. Data collection will be performed using current information systems. Process outcomes will be measured at the cluster level six months after the

  1. Application of super-omni wedge concept to conformal radiotherapy treatment planning

    International Nuclear Information System (INIS)

    Dai Jianrong; Fu Weihua; Hu Yimin

    2004-01-01

    Objective: To describe a method which can optimize beam weight, wedge angle, and wedge orientation simultaneously by combining the super-omni wedge (SOW) concept with the function of beam weight optimization provided by a commercial treatment planning system. Methods: A five-step procedure including: Step 1. To set up four 60 degree nominal wedged beams for each beam direction with the wedge orientations of 'LEFT', 'IN', 'RIGHT', 'OUT', respectively; Step 2. To define an optimization request, including an optimization goal and constraints. Authors use CMS Focus treatment planning system which allows us to choose 'maximize target dose' or 'minimize critical structure dose' as the optimization goal, and to set minimum target dose, maximum target dose, and maximum average dose of critical structures as constraints. Then the optimization process was launched as step 3; Step 4. To evaluate the plan using isodose distributions and dose-volume histograms. If acceptable, go to Step 5. Otherwise, go back to Step 2 to modify optimization constraints; and Step 5. Transform the SOW beams into the beams of omni wedge so as to reduce the number of to-be-delivered beams. Results: This procedure was found being able to demonstrate successfully in two clinical cases: an esophageal carcinoma and a brain tumor. Compared with manually designed plan, the optimized plan showed better dose homogeneity in the targets and better sparing of the critical structures. Conclusions: This method described is able to optimize beam weights while working with a treatment planning system. Not only does it improve treatment plans' quality, but also shorten the treatment planning process

  2. Community health promotion and medical provision for neonatal health-CHAMPION cluster randomised trial in Nagarkurnool district, Telangana (formerly Andhra Pradesh, India.

    Directory of Open Access Journals (Sweden)

    Peter Boone

    2017-07-01

    Full Text Available In the mid-2000s, neonatal mortality accounted for almost 40% of deaths of children under 5 years worldwide, and constituted 65% of infant deaths in India. The neonatal mortality rate in Andhra Pradesh was 44 per 1,000 live births, and was higher in the rural areas and tribal regions, such as the Nagarkurnool division of Mahabubnagar district (which became Nagarkurnool district in Telangana in 2014. The aim of the CHAMPION trial was to investigate whether a package of interventions comprising community health promotion and provision of health services (including outreach and facility-based care could lead to a reduction of the order of 25% in neonatal mortality.The design was a trial in which villages (clusters in Nagarkurnool with a population < 2,500 were randomised to the CHAMPION package of health interventions or to the control arm (in which children aged 6-9 years were provided with educational interventions-the STRIPES trial. A woman was eligible for the CHAMPION package if she was married and <50 years old, neither she nor her husband had had a family planning operation, and she resided in a trial village at the time of a baseline survey before randomisation or married into the village after randomisation. The CHAMPION intervention package comprised community health promotion (including health education via village health worker-led participatory discussion groups and provision of health services (including outreach, with mobile teams providing antenatal check-ups, and facility-based care, with subsidised access to non-public health centres [NPHCs]. Villages were stratified by travel time to the nearest NPHC and tribal status, and randomised (1:1 within strata. The primary outcome was neonatal mortality. Secondary outcomes included maternal mortality, causes of death, health knowledge, health practices including health service usage, satisfaction with care, and costs. The baseline survey (enumeration was carried out between August and

  3. Dosimetry and clinical implementation of dynamic wedge

    International Nuclear Information System (INIS)

    Klein, Eric E.; Low, Daniel A.; Meigooni, Ali S.; Purdy, James A.

    1995-01-01

    Purpose: Wedge-shaped isodoses are desired in a number of clinical situations. Physical wedge filters have provided nominal angled isodoses with dosimetric consequences of beam hardening, increased peripheral dosing, nonidealized gradients at deep depths, along with the practical consequences of filter handling and placement problems. Dynamic wedging uses a combination of a moving jaw and changing dose rate to achieve angled isodoses. The clinical implementation of dynamic wedge and an accompanying quality assurance program are discussed in detail. Methods and Materials: The accelerator at our facility has two photon energies (6 MV and 18 MV), currently with dynamic wedge angles of 15 deg. , 30 deg. , 45 deg. , and 60 deg. . The segmented treatment tables (STT) that drive the jaw in concert with a changing dose rate are unique for field sizes ranging from 4.0 cm to 20.0 cm in 05 cm steps, resulting in 256 STTs. Transmission wedge factors were measured for each STT with an ion chamber. Isodose profiles were accumulated with film after dose conversion. For treatment-planning purposes, d max orthogonal dose profiles were measured for open and dynamic fields. Physical filters were assigned empirically via the ratio of open and wedge profiles. Results: A nonlinear relationship with wedge factor and field size was found. The factors were found to be independent of the stationary field setting or second order blocking. Dynamic wedging provided more consistent gradients across the field compared with physical filters. Percent depth doses were found to be closer to open field. The created physical filters provided planned isodoses that closely resembled measured isodoses. Comparative isodose plans show improvement with dynamic wedging. Conclusions: Dynamic weding has practical and dosimetric advantages over physical filters. Table collisions with physical filters are alleviated. Treatment planning has been solved with an empirical solution. Dynamic wedge is a positive

  4. Effectiveness and implementation of an obesity prevention intervention: the HeLP-her Rural cluster randomised controlled trial.

    Science.gov (United States)

    Lombard, Catherine B; Harrison, Cheryce L; Kozica, Samantha L; Zoungas, Sophia; Keating, Catherine; Teede, Helena J

    2014-06-16

    To impact on the obesity epidemic, interventions that prevent weight gain across populations are urgently needed. However, even the most efficacious interventions will have little impact on obesity prevention unless they are successfully implemented in diverse populations and settings. Implementation research takes isolated efficacy studies into practice and policy and is particularly important in obesity prevention where there is an urgent need to accelerate the evidence to practice cycle. Despite the recognised need, few obesity prevention interventions have been implemented in real life settings and to our knowledge rarely target rural communities. Here we describe the rationale, design and implementation of a Healthy Lifestyle Program for women living in small rural communities (HeLP-her Rural). The primary goal of HeLP-her Rural is to prevent weight gain using a low intensity, self-management intervention. Six hundred women from 42 small rural communities in Australia will be randomised as clusters (n-21 control towns and n = 21 intervention towns). A pragmatic randomised controlled trial methodology will test efficacy and a comprehensive mixed methods community evaluation and cost analysis will inform effectiveness and implementation of this novel prevention program. Implementing population interventions to prevent obesity is complex, costly and challenging. To address these barriers, evidence based interventions need to move beyond isolated efficacy trials and report outcomes related to effectiveness and implementation. Large pragmatic trials provide an opportunity to inform both effectiveness and implementation leading to potential for greater impact at the population level. Pragmatic trials should incorporate both effectiveness and implementation outcomes and a multidimensional methodology to inform scale-up to population level. The learnings from this trial will impact on the design and implementation of population obesity prevention strategies

  5. The evaluation of enhanced feedback interventions to reduce unnecessary blood transfusions (AFFINITIE): protocol for two linked cluster randomised factorial controlled trials.

    Science.gov (United States)

    Hartley, Suzanne; Foy, Robbie; Walwyn, Rebecca E A; Cicero, Robert; Farrin, Amanda J; Francis, Jill J; Lorencatto, Fabiana; Gould, Natalie J; Grant-Casey, John; Grimshaw, Jeremy M; Glidewell, Liz; Michie, Susan; Morris, Stephen; Stanworth, Simon J

    2017-07-03

    Blood for transfusion is a frequently used clinical intervention, and is also a costly and limited resource with risks. Many transfusions are given to stable and non-bleeding patients despite no clear evidence of benefit from clinical studies. Audit and feedback (A&F) is widely used to improve the quality of healthcare, including appropriate use of blood. However, its effects are often inconsistent, indicating the need for coordinated research including more head-to-head trials comparing different ways of delivering feedback. A programmatic series of research projects, termed the 'Audit and Feedback INterventions to Increase evidence-based Transfusion practIcE' (AFFINITIE) programme, aims to test different ways of developing and delivering feedback within an existing national audit structure. The evaluation will comprise two linked 2×2 factorial, cross-sectional cluster-randomised controlled trials. Each trial will estimate the effects of two feedback interventions, 'enhanced content' and 'enhanced follow-on support', designed in earlier stages of the AFFINITIE programme, compared to current practice. The interventions will be embedded within two rounds of the UK National Comparative Audit of Blood Transfusion (NCABT) focusing on patient blood management in surgery and use of blood transfusions in patients with haematological malignancies. The unit of randomisation will be National Health Service (NHS) trust or health board. Clusters providing care relevant to the audit topics will be randomised following each baseline audit (separately for each trial), with stratification for size (volume of blood transfusions) and region (Regional Transfusion Committee). The primary outcome for each topic will be the proportion of patients receiving a transfusion coded as unnecessary. For each audit topic a linked, mixed-method fidelity assessment and cost-effectiveness analysis will be conducted in parallel to the trial. AFFINITIE involves a series of studies to explore how A

  6. Challenges of a community based pragmatic, randomised controlled trial of weight loss maintenance.

    Science.gov (United States)

    Randell, Elizabeth; McNamara, Rachel; Shaw, Christine; Espinasse, Aude; Simpson, Sharon Anne

    2015-12-18

    Randomised controlled trials (RCTs) have a reputation for being inherently difficult to deliver as planned and often face unforeseen challenges and delays, particularly in relation to organisational and governance difficulties, participant interest, constraints due to allocation of costs, local investigator interest and lengthy bureaucracy. Recruitment is often difficult and the challenges faced often impact on the cost and delivery of a successful trial within the funded period. This paper reflects upon the challenges faced in delivering a pragmatic RCT of weight loss maintenance in a community setting and suggests some potential solutions. The weight loss maintenance in adults trial aimed to evaluate the impact of a 12 month, individually tailored weight maintenance intervention on BMI 3 years from randomisation. Participants were recruited primarily from participant identification centres (PICs)-GP surgeries, exercise on referral schemes and slimming world. The intervention was delivered in community settings. A recruitment strategy implementation plan was drafted to address and monitor poor recruitment. Delays in opening and recruitment were experienced early on. Some were beyond the control of the study team such as; disagreement over allocation of national health service costs and PIC classification as well as difficulties in securing support from research networks. That the intervention was delivered in community settings was often at the root of these issues. Key items to address at the design stage of future trials include feasibility of eligibility criteria. The most effective element of the recruitment implementation plan was to refocus sources of recruitment and target only those who could fulfil the eligibility criteria immediately. Learnings from this trial should be kept in mind by those designing similar studies in the future. Considering potential governance, cost and research network support implications at the design stage of pragmatic trials of

  7. Introducing a Clustering Step in a Consensus Approach for the Scoring of Protein-Protein Docking Models

    KAUST Repository

    Chermak, Edrisse; De Donato, Renato; Lensink, Marc F.; Petta, Andrea; Serra, Luigi; Scarano, Vittorio; Cavallo, Luigi; Oliva, Romina

    2016-01-01

    Correctly scoring protein-protein docking models to single out native-like ones is an open challenge. It is also an object of assessment in CAPRI (Critical Assessment of PRedicted Interactions), the community-wide blind docking experiment. We introduced in the field the first pure consensus method, CONSRANK, which ranks models based on their ability to match the most conserved contacts in the ensemble they belong to. In CAPRI, scorers are asked to evaluate a set of available models and select the top ten ones, based on their own scoring approach. Scorers' performance is ranked based on the number of targets/interfaces for which they could provide at least one correct solution. In such terms, blind testing in CAPRI Round 30 (a joint prediction round with CASP11) has shown that critical cases for CONSRANK are represented by targets showing multiple interfaces or for which only a very small number of correct solutions are available. To address these challenging cases, CONSRANK has now been modified to include a contact-based clustering of the models as a preliminary step of the scoring process. We used an agglomerative hierarchical clustering based on the number of common inter-residue contacts within the models. Two criteria, with different thresholds, were explored in the cluster generation, setting either the number of common contacts or of total clusters. For each clustering approach, after selecting the top (most populated) ten clusters, CONSRANK was run on these clusters and the top-ranked model for each cluster was selected, in the limit of 10 models per target. We have applied our modified scoring approach, Clust-CONSRANK, to SCORE_SET, a set of CAPRI scoring models made recently available by CAPRI assessors, and to the subset of homodimeric targets in CAPRI Round 30 for which CONSRANK failed to include a correct solution within the ten selected models. Results show that, for the challenging cases, the clustering step typically enriches the ten top ranked

  8. Introducing a Clustering Step in a Consensus Approach for the Scoring of Protein-Protein Docking Models

    KAUST Repository

    Chermak, Edrisse

    2016-11-15

    Correctly scoring protein-protein docking models to single out native-like ones is an open challenge. It is also an object of assessment in CAPRI (Critical Assessment of PRedicted Interactions), the community-wide blind docking experiment. We introduced in the field the first pure consensus method, CONSRANK, which ranks models based on their ability to match the most conserved contacts in the ensemble they belong to. In CAPRI, scorers are asked to evaluate a set of available models and select the top ten ones, based on their own scoring approach. Scorers\\' performance is ranked based on the number of targets/interfaces for which they could provide at least one correct solution. In such terms, blind testing in CAPRI Round 30 (a joint prediction round with CASP11) has shown that critical cases for CONSRANK are represented by targets showing multiple interfaces or for which only a very small number of correct solutions are available. To address these challenging cases, CONSRANK has now been modified to include a contact-based clustering of the models as a preliminary step of the scoring process. We used an agglomerative hierarchical clustering based on the number of common inter-residue contacts within the models. Two criteria, with different thresholds, were explored in the cluster generation, setting either the number of common contacts or of total clusters. For each clustering approach, after selecting the top (most populated) ten clusters, CONSRANK was run on these clusters and the top-ranked model for each cluster was selected, in the limit of 10 models per target. We have applied our modified scoring approach, Clust-CONSRANK, to SCORE_SET, a set of CAPRI scoring models made recently available by CAPRI assessors, and to the subset of homodimeric targets in CAPRI Round 30 for which CONSRANK failed to include a correct solution within the ten selected models. Results show that, for the challenging cases, the clustering step typically enriches the ten top ranked

  9. Clustering coefficient and community structure of bipartite networks

    Science.gov (United States)

    Zhang, Peng; Wang, Jinliang; Li, Xiaojia; Li, Menghui; Di, Zengru; Fan, Ying

    2008-12-01

    Many real-world networks display natural bipartite structure, where the basic cycle is a square. In this paper, with the similar consideration of standard clustering coefficient in binary networks, a definition of the clustering coefficient for bipartite networks based on the fraction of squares is proposed. In order to detect community structures in bipartite networks, two different edge clustering coefficients LC4 and LC3 of bipartite networks are defined, which are based on squares and triples respectively. With the algorithm of cutting the edge with the least clustering coefficient, communities in artificial and real world networks are identified. The results reveal that investigating bipartite networks based on the original structure can show the detailed properties that is helpful to get deep understanding about the networks.

  10. The effectiveness of Stepping Stones Triple P: the design of a randomised controlled trial on a parenting programme regarding children with mild intellectual disability and psychosocial problems versus care as usual.

    Science.gov (United States)

    Kleefman, Marijke; Jansen, Daniëlle E M C; Reijneveld, Sijmen A

    2011-08-30

    Children with an intellectual disability are at increased risk of psychosocial problems. This leads to serious restrictions in the daily functioning of the children and to parental stress. Stepping Stones Triple P aims to prevent severe behavioural, emotional and developmental problems in children with a (intellectual) disability by enhancing parenting knowledge and skills, and the self-confidence of parents. This paper aims to describe the design of a study of the effectiveness of parenting counselling using Stepping Stones Triple P compared to Care as Usual. The effects of Stepping Stones Triple P will be studied in a Randomised Controlled Trial. Parents of children aged 5-12 years with an IQ of 50-85 will be recruited from schools. Prior to randomisation, parents complete a screening questionnaire about their child's psychosocial problems and their parenting skills. Subsequently, parents of children with increased levels of psychosocial problems (score on Strengths and Difficulties Questionnaire ≥ 14) will be invited to participate in the intervention study. After obtaining consent, parents will be randomised either to the experimental group (Stepping Stones Triple P) or to Care as Usual. The primary outcome is a change in the child's psychosocial problems according to parents and teachers. The secondary outcome is a change in parenting skills. Data will be collected before the start of the intervention, immediately after the intervention, and six months after. This paper presents an outline of the background and design of a randomised controlled trial to investigate the effectiveness of Stepping Stones Triple P, which aims to decrease psychosocial problems in children with a mild intellectual disability. Stepping Stones Triple P seems promising, but evidence on its effectiveness for this population is still lacking. This study provides evidence about the effects of this intervention in a community-based population of children with a mild intellectual

  11. A cluster-randomised, controlled trial to assess the impact of a workplace osteoporosis prevention intervention on the dietary and physical activity behaviours of working women: study protocol

    OpenAIRE

    Tan, Ai May; LaMontagne, Anthony D; Sarmugam, Rani; Howard, Peter

    2013-01-01

    Background Osteoporosis is a debilitating disease and its risk can be reduced through adequate calcium consumption and physical activity. This protocol paper describes a workplace-based intervention targeting behaviour change in premenopausal women working in sedentary occupations. Method/Design A cluster-randomised design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the clusters and units of randomisation and intervention. Sample size calculat...

  12. Effects of a parenting intervention to address maternal psychological wellbeing and child development and growth in rural Uganda: a community-based, cluster randomised trial.

    Science.gov (United States)

    Singla, Daisy R; Kumbakumba, Elias; Aboud, Frances E

    2015-08-01

    Parenting interventions have been implemented to improve the compromised developmental potential among 39% of children younger than 5 years living in low-income and middle-income countries. Maternal wellbeing is important for child development, especially in children younger than 3 years who are vulnerable and dependent on their mothers for nutrition and stimulation. We assessed an integrated, community-based parenting intervention that targeted both child development and maternal wellbeing in rural Uganda. In this community-based, cluster randomised trial, we assessed the effectiveness of a manualised, parenting intervention in Lira, Uganda. We selected and randomly assigned 12 parishes (1:1) to either parenting intervention or control (inclusion on a waitlist with a brief message on nutrition) groups using a computer-generated list of random numbers. Within each parish, we selected two to three eligible communities that had a parish office or a primary school in which a preschool could be established, more than 75 households with children younger than 6 years, and at least 15 socially disadvantaged families (ie, maternal education of primary school level or lower) with at least one child younger than 36 months. Participants within communities were mother-child dyads, where the child was 12-36 months of age at enrollment, and the mother had low maternal education. In the parenting intervention group, participants attended 12 fortnightly peer-led group sessions focusing on child care and maternal wellbeing. The primary outcomes were cognitive and receptive language development, as measured with the Bayley Scales of Infant Development, 3rd edn. Secondary outcomes included self-reported maternal depressive symptoms, using the Center for Epidemiologic Studies Depression Scale, and child growth. Theoretically-relevant parenting practices, including the Home Observation for Measurement of the Environment inventory, and mother-care variables, such as perceived spousal

  13. Efficacy of community-based physiotherapy networks for patients with Parkinson's disease: a cluster-randomised trial.

    NARCIS (Netherlands)

    Munneke, M.; Nijkrake, M.J.; Keus, S.H.J.; Kwakkel, G.; Berendse, H.W.; Roos, R.A.; Borm, G.F.; Adang, E.M.M.; Overeem, S.; Bloem, B.R.

    2010-01-01

    BACKGROUND: Many patients with Parkinson's disease are treated with physiotherapy. We have developed a community-based professional network (ParkinsonNet) that involves training of a selected number of expert physiotherapists to work according to evidence-based recommendations, and structured

  14. Efficacy of community-based physiotherapy networks for patients with Parkinson's disease: a cluster-randomised trial

    NARCIS (Netherlands)

    Munneke, M.; Nijkrake, M.J.; Keus, S.H.; Kwakkel, G.; Berendse, H.W.; Roos, R.A.; Borm, G.F.; Adang, E.M.; Overeem, S.; Bloem, B.R.

    2010-01-01

    Background: Many patients with Parkinson's disease are treated with physiotherapy. We have developed a community-based professional network (ParkinsonNet) that involves training of a selected number of expert physiotherapists to work according to evidence-based recommendations, and structured

  15. Evidence-based care of older people with suspected cognitive impairment in general practice: protocol for the IRIS cluster randomised trial.

    Science.gov (United States)

    McKenzie, Joanne E; French, Simon D; O'Connor, Denise A; Mortimer, Duncan S; Browning, Colette J; Russell, Grant M; Grimshaw, Jeremy M; Eccles, Martin P; Francis, Jill J; Michie, Susan; Murphy, Kerry; Kossenas, Fiona; Green, Sally E

    2013-08-19

    Dementia is a common and complex condition. Evidence-based guidelines for the management of people with dementia in general practice exist; however, detection, diagnosis and disclosure of dementia have been identified as potential evidence-practice gaps. Interventions to implement guidelines into practice have had varying success. The use of theory in designing implementation interventions has been limited, but is advocated because of its potential to yield more effective interventions and aid understanding of factors modifying the magnitude of intervention effects across trials. This protocol describes methods of a randomised trial that tests a theory-informed implementation intervention that, if effective, may provide benefits for patients with dementia and their carers. This trial aims to estimate the effectiveness of a theory-informed intervention to increase GPs' (in Victoria, Australia) adherence to a clinical guideline for the detection, diagnosis, and management of dementia in general practice, compared with providing GPs with a printed copy of the guideline. Primary objectives include testing if the intervention is effective in increasing the percentage of patients with suspected cognitive impairment who receive care consistent with two key guideline recommendations: receipt of a i) formal cognitive assessment, and ii) depression assessment using a validated scale (primary outcomes for the trial). The design is a parallel cluster randomised trial, with clusters being general practices. We aim to recruit 60 practices per group. Practices will be randomised to the intervention and control groups using restricted randomisation. Patients meeting the inclusion criteria, and GPs' detection and diagnosis behaviours directed toward these patients, will be identified and measured via an electronic search of the medical records nine months after the start of the intervention. Practitioners in the control group will receive a printed copy of the guideline. In

  16. Cluster synchronization for directed community networks via pinning partial schemes

    International Nuclear Information System (INIS)

    Hu Cheng; Jiang Haijun

    2012-01-01

    Highlights: ► Cluster synchronization for directed community networks is proposed by pinning partial schemes. ► Each community is considered as a whole. ► Several novel pinning criteria are derived based on the information of communities. ► A numerical example with simulation is provided. - Abstract: In this paper, we focus on driving a class of directed networks to achieve cluster synchronization by pinning schemes. The desired cluster synchronization states are no longer decoupled orbits but a set of un-decoupled trajectories. Each community is considered as a whole and the synchronization criteria are derived based on the information of communities. Several pinning schemes including feedback control and adaptive strategy are proposed to select controlled communities by analyzing the information of each community such as indegrees and outdegrees. In all, this paper answers several challenging problems in pinning control of directed community networks: (1) What communities should be chosen as controlled candidates? (2) How many communities are needed to be controlled? (3) How large should the control gains be used in a given community network to achieve cluster synchronization? Finally, an example with numerical simulations is given to demonstrate the effectiveness of the theoretical results.

  17. Effectiveness and safety of misoprostol distributed to antenatal women to prevent postpartum haemorrhage after child-births: a stepped-wedge cluster-randomized trial.

    Science.gov (United States)

    Ononge, Sam; Campbell, Oona M R; Kaharuza, Frank; Lewis, James J; Fielding, Katherine; Mirembe, Florence

    2015-11-26

    Oral misoprostol, administered by trained health-workers is effective and safe for preventing postpartum haemorrhage (PPH). There is interest in expanding administration of misoprostol by non-health workers, including task-shifting to pregnant women themselves. However, the use of misoprostol for preventing PPH in home-births remains controversial, due to the limited evidence to support self-administration or leaving it in the hands of non-health workers. This study aimed to determine if antenatally distributing misoprostol to pregnant women to self-administer at home birth reduces PPH. Between February 2013 and March 2014, we conducted a stepped-wedge cluster-randomized trial in six health facilities in Central Uganda. Women at 28+ weeks of gestation attending antenatal care were eligible. Women in the control-arm received the standard-of-care; while the intervention-arm were offered 600 mcg of misoprostol to swallow immediately after birth of baby, when oxytocin was not available. The primary outcome (PPH) was a drop in postpartum maternal haemoglobin (Hb) by ≥ 2 g/dl, lower than the prenatal Hb. Analysis was by intention-to-treat at the cluster level and we used a paired t-tests to assess whether the mean difference between the control and intervention groups was statistically significant. 97% (2466/2545) of eligible women consented to participate; 1430 and 1036 in the control and intervention arms respectively. Two thousand fifty-seven of the participants were successfully followed up and 271 (13.2%) delivered outside a health facility. There was no significant difference between the study group in number of women who received a uterotonic at birth (control 80.4% vs intervention 91.4%, mean difference = -11.0%, 95% confidence interval [CI] -25.7% to 3.6%, p = 0.11). No woman took misoprostol before their baby's birth. Shivering and fever were 14.9% in the control arm compared to 22.2% in the intervention arm (mean difference = -7.2%, 95% CI -11.1% to -3

  18. Regional health care planning: a methodology to cluster facilities using community utilization patterns.

    Science.gov (United States)

    Delamater, Paul L; Shortridge, Ashton M; Messina, Joseph P

    2013-08-22

    Community-based health care planning and regulation necessitates grouping facilities and areal units into regions of similar health care use. Limited research has explored the methodologies used in creating these regions. We offer a new methodology that clusters facilities based on similarities in patient utilization patterns and geographic location. Our case study focused on Hospital Groups in Michigan, the allocation units used for predicting future inpatient hospital bed demand in the state's Bed Need Methodology. The scientific, practical, and political concerns that were considered throughout the formulation and development of the methodology are detailed. The clustering methodology employs a 2-step K-means + Ward's clustering algorithm to group hospitals. The final number of clusters is selected using a heuristic that integrates both a statistical-based measure of cluster fit and characteristics of the resulting Hospital Groups. Using recent hospital utilization data, the clustering methodology identified 33 Hospital Groups in Michigan. Despite being developed within the politically charged climate of Certificate of Need regulation, we have provided an objective, replicable, and sustainable methodology to create Hospital Groups. Because the methodology is built upon theoretically sound principles of clustering analysis and health care service utilization, it is highly transferable across applications and suitable for grouping facilities or areal units.

  19. Evaluation of wedge-shaped phantoms for assessment of scanner display as a part of quality control of scanner performance

    International Nuclear Information System (INIS)

    Bergmann, H.; Havlik, E.

    1981-01-01

    Image manipulation in modern rectilinear scanners comprises background subtraction and contrast enhancement facilities. It has been the aim of this investigation to develop simple quality assurance methods suitable for checking the function of these features on a routine basis. Several types of phantoms have been investigated: an absorption step wedge, an emission step wedge and an emission continuous wedge. The absorption step wedge when used with a usual gamma-camera checking source gave the least satisfactory results. The emission step wedge is best suited for test procedures for background subtraction of the colour printer display and for contrast enhancement of the photo display, whereas the emission continuous wedge gave best results in testing the contrast enhancement of the colour printer display. An evaluation of the relative merits of the phantoms indicates that the emission step wedge is best suited for quality assurance tests. (author)

  20. Efficacy of a movement control injury prevention programme in adult men’s community rugby union: a cluster randomised controlled trial

    Science.gov (United States)

    Attwood, Matthew J; Roberts, Simon P; Trewartha, Grant; England, Mike E; Stokes, Keith A

    2018-01-01

    Background Exercise programmes aimed at reducing injury have been shown to be efficacious for some non-collision sports, but evidence in adult men’s collision sports such as rugby union is lacking. Objective To evaluate the efficacy of a movement control injury prevention exercise programme for reducing match injuries in adult men’s community rugby union players. Methods 856 clubs were invited to participate in this prospective cluster randomised (single-blind) controlled trial where clubs were the unit of randomisation. 81 volunteered and were randomly assigned (intervention/control). A 42-week exercise programme was followed throughout the season. The control programme reflected ‘normal practice’ exercises, whereas the intervention focused on proprioception, balance, cutting, landing and resistance exercises. Outcome measures were match injury incidence and burden for: (1) all ≥8 days time-loss injuries and (2) targeted (lower limb, shoulder, head and neck, excluding fractures and lacerations) ≥8 days time-loss injuries. Results Poisson regression identified no clear effects on overall injury outcomes. A likely beneficial difference in targeted injury incidence (rate ratio (RR), 90% CI=0.6, 0.4 to 1.0) was identified, with a 40% reduction in lower-limb incidence (RR, 90% CI=0.6, 0.4 to 1.0) and a 60% reduction in concussion incidence (RR, 90% CI=0.4, 0.2 to 0.7) in the intervention group. Comparison between arms for clubs with highest compliance (≥median compliance) demonstrated very likely beneficial 60% reductions in targeted injury incidence (RR, 90% CI=0.4, 0.2 to 0.8) and targeted injury burden (RR, 90% CI=0.4, 0.2 to 0.7). Conclusions The movement control injury prevention programme resulted in likely beneficial reductions in lower-limb injuries and concussion. Higher intervention compliance was associated with reduced targeted injury incidence and burden. PMID:29055883

  1. Modelling the wedge shape for the virtual wedge

    International Nuclear Information System (INIS)

    Chang Liyun; Ho Shengyow; Chen, Helen H W

    2003-01-01

    We present a method to model the virtual wedge shape in a 3D treatment planning system as a physical wedge. The virtual wedge shape was determined using the measured dose profile of the virtual wedge at a chosen reference depth. The differences between the calculated and the measured dose profiles for the virtual wedge were within 0.5% at the reference depth, and within 2.5% at other depths. This method provides a fast and accurate way to implement the virtual wedge into our planning system for any wedge angles. This method is also applicable to model the physical wedge shapes with comparable good results

  2. Understanding the cluster randomised crossover design: a graphical illustraton of the components of variation and a sample size tutorial.

    Science.gov (United States)

    Arnup, Sarah J; McKenzie, Joanne E; Hemming, Karla; Pilcher, David; Forbes, Andrew B

    2017-08-15

    In a cluster randomised crossover (CRXO) design, a sequence of interventions is assigned to a group, or 'cluster' of individuals. Each cluster receives each intervention in a separate period of time, forming 'cluster-periods'. Sample size calculations for CRXO trials need to account for both the cluster randomisation and crossover aspects of the design. Formulae are available for the two-period, two-intervention, cross-sectional CRXO design, however implementation of these formulae is known to be suboptimal. The aims of this tutorial are to illustrate the intuition behind the design; and provide guidance on performing sample size calculations. Graphical illustrations are used to describe the effect of the cluster randomisation and crossover aspects of the design on the correlation between individual responses in a CRXO trial. Sample size calculations for binary and continuous outcomes are illustrated using parameters estimated from the Australia and New Zealand Intensive Care Society - Adult Patient Database (ANZICS-APD) for patient mortality and length(s) of stay (LOS). The similarity between individual responses in a CRXO trial can be understood in terms of three components of variation: variation in cluster mean response; variation in the cluster-period mean response; and variation between individual responses within a cluster-period; or equivalently in terms of the correlation between individual responses in the same cluster-period (within-cluster within-period correlation, WPC), and between individual responses in the same cluster, but in different periods (within-cluster between-period correlation, BPC). The BPC lies between zero and the WPC. When the WPC and BPC are equal the precision gained by crossover aspect of the CRXO design equals the precision lost by cluster randomisation. When the BPC is zero there is no advantage in a CRXO over a parallel-group cluster randomised trial. Sample size calculations illustrate that small changes in the specification of

  3. A multimodal intervention to improve hand hygiene in ICUs in Buenos Aires, Argentina: a stepped wedge trial.

    Science.gov (United States)

    Rodriguez, Viviana; Giuffre, Carolina; Villa, Silvia; Almada, Griselda; Prasopa-Plaizier, Nittita; Gogna, Monica; Gibbons, Luz; García Elorrio, Ezequiel

    2015-10-01

    Hand hygiene is a cost-effective measure to reduce microbial transmission (Teare EL, Cookson B, French GL, et al. UK handwashing initiative. J Hosp Infect. 1999;43:1-3.) and is considered to be the most important measure to prevent healthcare-associated infections (Pittet D, Allegranzi B, Sax H, Evidence-based model for hand transmission during patient care and the role of improved practices. Lancet Infect Dis 2006;6:641-52). Unfortunately, the compliance rate of healthcare workers (HCWs) with recommended hand hygiene procedures is less than expected. In order to estimate the effect of a multimodal intervention on improving healthcare workers' compliance with hand hygiene in eleven intensive care units (ICUs) from 11 hospitals of Buenos Aires, a randomized cluster-stepped wedge trial was designed. A multimodal intervention was designed based on practices characterized by being evidence-based, low cost and suggested by qualitative research: (i) leadership commitment, (ii) surveillance of materials needed to comply with hand hygiene and alcohol consumption, (iii) utilization of reminders, (iv) a storyboard of the project and (v) feedback (hand hygiene compliance rate). The study enrolled 705 participants, comprising nurses (66.4%), physicians (25.8%) and other HCW (7.8%) along 9 months of observation. Compliance with hand hygiene in the control group was 66.0% (2354/3565) vs. 75.6% (5190/6864) in the intervention group. Univariate analysis showed an association between the intervention and hand hygiene compliance (odds ratio, OR 1.17; 95% confidence interval (CI), 1.13-1.22). The effect was still present after adjustment by calendar's time and providers' characteristics-age, gender and profession (OR 1.08; 95% CI, 1.03-1.14). His study supports that a multimodal intervention was effective to improve compliance with hand hygiene in ICUs. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care

  4. Comparison of dosimetric methods for virtual wedge analysis

    International Nuclear Information System (INIS)

    Bailey, M.; Nelson, V.; Collins, O.; West, M.; Holloway, L.; Rajapaske, S.; Arts, J.; Varas, J.; Cho, G.; Hill, R.

    2004-01-01

    Full text: The Siemens Virtual Wedge (Concord, USA) creates wedged beam profile by moving a single collimator jaw across the specified field size whilst varying the dose rate and jaw speed for use in the delivery of radiotherapy treatments. The measurement of the dosimetric characteristics of the Siemens Virtual Wedge poses significant challenges to medical physicists. This study investigates several different methods for measuring and analysing the virtual wedge for data collection for treatment planning systems and ongoing quality assurance. The beam profiles of the Virtual Wedge (VW) were compared using several different dosimetric methods. Open field profiles were measured with Kodak X-Omat V (Rochester, NY, USA) radiographic film and compared with measurements made using the Sun Nuclear Profiler with a Motorized Drive Assembly (MDA) (Melbourne, FL, USA) and the Scanditronix Wellhofer CC13 ionisation chamber and 24 ion Chamber Array (CA24) (Schwarzenbruck, Germany). The resolution of each dosimetric method for open field profiles was determined. The Virtual Wedge profiles were measured with radiographic film the Profiler and the Scanditronix Wellhofer CA 24 ion Chamber Array at 5 different depths. The ease of setup, time taken, analysis and accuracy of measurement were all evaluated to determine the method that would be both appropriate and practical for routine quality assurance of the Virtual Wedge. The open field profiles agreed within ±2% or 2mm for all dosimetric methods. The accuracy of the Profiler and CA24 are limited to half of the step size selected for each of these detectors. For the VW measurements a step size of 2mm was selected for the Profiler and the CA24. The VW profiles for all dosimetric methods agreed within ±2% or 2mm for the main wedged section of the profile. The toe and heel ends of the wedges showed the significant discrepancies dependent upon the dosimetry method used, up to 7% for the toe end with the CA24. The dosimetry of the

  5. 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).

    Science.gov (United States)

    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

  6. A pragmatic cluster randomised trial evaluating three implementation interventions

    Directory of Open Access Journals (Sweden)

    Rycroft-Malone Jo

    2012-08-01

    Full Text Available Abstract Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA. The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first

  7. Stores Healthy Options Project in Remote Indigenous Communities (SHOP@RIC): a protocol of a randomised trial promoting healthy food and beverage purchases through price discounts and in-store nutrition education.

    Science.gov (United States)

    Brimblecombe, Julie; Ferguson, Megan; Liberato, Selma C; Ball, Kylie; Moodie, Marjory L; Magnus, Anne; Miles, Edward; Leach, Amanda J; Chatfield, Mark D; Ni Mhurchu, Cliona; O'Dea, Kerin; Bailie, Ross S

    2013-08-12

    Indigenous Australians suffer a disproportionate burden of preventable chronic disease compared to their non-Indigenous counterparts--much of it diet-related. Increasing fruit and vegetable intakes and reducing sugar-sweetened soft-drink consumption can reduce the risk of preventable chronic disease. There is evidence from some general population studies that subsidising healthier foods can modify dietary behaviour. There is little such evidence relating specifically to socio-economically disadvantaged populations, even though dietary behaviour in such populations is arguably more likely to be susceptible to such interventions.This study aims to assess the impact and cost-effectiveness of a price discount intervention with or without an in-store nutrition education intervention on purchases of fruit, vegetables, water and diet soft-drinks among remote Indigenous communities. We will utilise a randomised multiple baseline (stepped wedge) design involving 20 communities in remote Indigenous Australia. The study will be conducted in partnership with two store associations and twenty Indigenous store boards. Communities will be randomised to either i) a 20% price discount on fruit, vegetables, water and diet soft-drinks; or ii) a combined price discount and in-store nutrition education strategy. These interventions will be initiated, at one of five possible time-points, spaced two-months apart. Weekly point-of-sale data will be collected from each community store before, during, and for six months after the six-month intervention period to measure impact on purchasing of discounted food and drinks. Data on physical, social and economic factors influencing weekly store sales will be collected in order to identify important covariates. Intervention fidelity and mediators of behaviour change will also be assessed. This study will provide original evidence on the effectiveness and cost-effectiveness of price discounts with or without an in-store nutrition education

  8. Innovation in a Learning Health Care System: Veteran-Directed Home- and Community-Based Services.

    Science.gov (United States)

    Garrido, Melissa M; Allman, Richard M; Pizer, Steven D; Rudolph, James L; Thomas, Kali S; Sperber, Nina R; Van Houtven, Courtney H; Frakt, Austin B

    2017-11-01

    A path-breaking example of the interplay between geriatrics and learning healthcare systems is the Veterans Health Administration's (VHA's) planned roll-out of a program for providing participant-directed home- and community-based services to veterans with cognitive and functional limitations. We describe the design of a large-scale, stepped-wedge, cluster-randomized trial of the Veteran-Directed Home- and Community-Based Services (VD-HCBS) program. From March 2017 through December 2019, up to 77 Veterans Affairs Medical Centers will be randomized to times to begin offering VD-HCBS to veterans at risk of nursing home placement. Services will be provided to community-dwelling participants with support from Aging and Disability Network Agencies. The VHA Partnered Evidence-based Policy Resource Center (PEPReC) is coordinating the evaluation, which includes collaboration from operational stakeholders from the VHA and Administration for Community Living and interdisciplinary researchers from the Center of Innovation in Long-Term Services and Supports and the Center for Health Services Research in Primary Care. For older veterans with functional limitations who are eligible for VD-HCBS, we will evaluate health outcomes (hospitalizations, emergency department visits, nursing home admissions, days at home) and healthcare costs associated with VD-HCBS availability. Learning healthcare systems facilitate diffusion of innovation while enabling rigorous evaluation of effects on patient outcomes. The VHA's randomized rollout of VD-HCBS to veterans at risk of nursing home placement is an example of how to achieve these goals simultaneously. PEPReC's experience designing an evaluation with researchers and operations stakeholders may serve as a framework for others seeking to develop rapid, rigorous, large-scale evaluations of delivery system innovations targeted to older adults. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

  9. The effectiveness of Stepping stones Triple P: the design of a randomised controlled trial on a parenting programme regarding children with mild intellectual disability and psychosocial problems versus care as usual

    Science.gov (United States)

    2011-01-01

    Background Children with an intellectual disability are at increased risk of psychosocial problems. This leads to serious restrictions in the daily functioning of the children and to parental stress. Stepping Stones Triple P aims to prevent severe behavioural, emotional and developmental problems in children with a (intellectual) disability by enhancing parenting knowledge and skills, and the self-confidence of parents. This paper aims to describe the design of a study of the effectiveness of parenting counselling using Stepping Stones Triple P compared to Care as Usual. Methods/Design The effects of Stepping Stones Triple P will be studied in a Randomised Controlled Trial. Parents of children aged 5-12 years with an IQ of 50-85 will be recruited from schools. Prior to randomisation, parents complete a screening questionnaire about their child's psychosocial problems and their parenting skills. Subsequently, parents of children with increased levels of psychosocial problems (score on Strengths and Difficulties Questionnaire ≥ 14) will be invited to participate in the intervention study. After obtaining consent, parents will be randomised either to the experimental group (Stepping Stones Triple P) or to Care as Usual. The primary outcome is a change in the child's psychosocial problems according to parents and teachers. The secondary outcome is a change in parenting skills. Data will be collected before the start of the intervention, immediately after the intervention, and six months after. Discussion This paper presents an outline of the background and design of a randomised controlled trial to investigate the effectiveness of Stepping Stones Triple P, which aims to decrease psychosocial problems in children with a mild intellectual disability. Stepping Stones Triple P seems promising, but evidence on its effectiveness for this population is still lacking. This study provides evidence about the effects of this intervention in a community-based population of

  10. The effectiveness of Stepping stones Triple P: the design of a randomised controlled trial on a parenting programme regarding children with mild intellectual disability and psychosocial problems versus care as usual

    Directory of Open Access Journals (Sweden)

    Jansen Daniëlle EMC

    2011-08-01

    Full Text Available Abstract Background Children with an intellectual disability are at increased risk of psychosocial problems. This leads to serious restrictions in the daily functioning of the children and to parental stress. Stepping Stones Triple P aims to prevent severe behavioural, emotional and developmental problems in children with a (intellectual disability by enhancing parenting knowledge and skills, and the self-confidence of parents. This paper aims to describe the design of a study of the effectiveness of parenting counselling using Stepping Stones Triple P compared to Care as Usual. Methods/Design The effects of Stepping Stones Triple P will be studied in a Randomised Controlled Trial. Parents of children aged 5-12 years with an IQ of 50-85 will be recruited from schools. Prior to randomisation, parents complete a screening questionnaire about their child's psychosocial problems and their parenting skills. Subsequently, parents of children with increased levels of psychosocial problems (score on Strengths and Difficulties Questionnaire ≥ 14 will be invited to participate in the intervention study. After obtaining consent, parents will be randomised either to the experimental group (Stepping Stones Triple P or to Care as Usual. The primary outcome is a change in the child's psychosocial problems according to parents and teachers. The secondary outcome is a change in parenting skills. Data will be collected before the start of the intervention, immediately after the intervention, and six months after. Discussion This paper presents an outline of the background and design of a randomised controlled trial to investigate the effectiveness of Stepping Stones Triple P, which aims to decrease psychosocial problems in children with a mild intellectual disability. Stepping Stones Triple P seems promising, but evidence on its effectiveness for this population is still lacking. This study provides evidence about the effects of this intervention in a community-based

  11. Efficacy of a movement control injury prevention programme in adult men's community rugby union: a cluster randomised controlled trial.

    Science.gov (United States)

    Attwood, Matthew J; Roberts, Simon P; Trewartha, Grant; England, Mike E; Stokes, Keith A

    2018-03-01

    Exercise programmes aimed at reducing injury have been shown to be efficacious for some non-collision sports, but evidence in adult men's collision sports such as rugby union is lacking. To evaluate the efficacy of a movement control injury prevention exercise programme for reducing match injuries in adult men's community rugby union players. 856 clubs were invited to participate in this prospective cluster randomised (single-blind) controlled trial where clubs were the unit of randomisation. 81 volunteered and were randomly assigned (intervention/control). A 42-week exercise programme was followed throughout the season. The control programme reflected 'normal practice' exercises, whereas the intervention focused on proprioception, balance, cutting, landing and resistance exercises.Outcome measures were match injury incidence and burden for: (1) all ≥8 days time-loss injuries and (2) targeted (lower limb, shoulder, head and neck, excluding fractures and lacerations) ≥8 days time-loss injuries. Poisson regression identified no clear effects on overall injury outcomes. A likely beneficial difference in targeted injury incidence (rate ratio (RR), 90% CI=0.6, 0.4 to 1.0) was identified, with a 40% reduction in lower-limb incidence (RR, 90% CI=0.6, 0.4 to 1.0) and a 60% reduction in concussion incidence (RR, 90% CI=0.4, 0.2 to 0.7) in the intervention group. Comparison between arms for clubs with highest compliance (≥median compliance) demonstrated very likely beneficial 60% reductions in targeted injury incidence (RR, 90% CI=0.4, 0.2 to 0.8) and targeted injury burden (RR, 90% CI=0.4, 0.2 to 0.7). The movement control injury prevention programme resulted in likely beneficial reductions in lower-limb injuries and concussion. Higher intervention compliance was associated with reduced targeted injury incidence and burden. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is

  12. The effectiveness of a clinically integrated e-learning course in evidence-based medicine: A cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Arvanitis Theodoros N

    2009-05-01

    Full Text Available Abstract Background To evaluate the educational effects of a clinically integrated e-learning course for teaching basic evidence-based medicine (EBM among postgraduates compared to a traditional lecture-based course of equivalent content. Methods We conducted a cluster randomised controlled trial in the Netherlands and the UK involving postgraduate trainees in six obstetrics and gynaecology departments. Outcomes (knowledge gain and change in attitude towards EBM were compared between the clinically integrated e-learning course (intervention and the traditional lecture based course (control. We measured change from pre- to post-intervention scores using a validated questionnaire assessing knowledge (primary outcome and attitudes (secondary outcome. Results There were six clusters involving teaching of 61 postgraduate trainees (28 in the intervention and 33 in the control group. The intervention group achieved slightly higher scores for knowledge gain compared to the control, but these results were not statistically significant (difference in knowledge gain: 3.5 points, 95% CI -2.7 to 9.8, p = 0.27. The attitudinal changes were similar for both groups. Conclusion A clinically integrated e-learning course was at least as effective as a traditional lecture based course and was well accepted. Being less costly than traditional teaching and allowing for more independent learning through materials that can be easily updated, there is a place for incorporating e-learning into postgraduate EBM curricula that offer on-the-job training for just-in-time learning. Trial registration Trial registration number: ACTRN12609000022268.

  13. Physical characteristics comparison of virtual wedge device with physical wedge

    International Nuclear Information System (INIS)

    Cho, Jung Keun; Choi, Kye Sook; Lim, Cheong Hwan; Kim, Jeong Koo; Jung, Hong Ryang; Lee, Jung Ok; Lee, Man Goo

    2001-01-01

    We compared the characteristics of Siemens virtual wedge device with physical wedges for clinical application. We investigated the characteristics of virtual and physical wedges for various wedge angles (15, 30, 45, and 60) using 6- and 15- MV photon beams. Wedge factors were measured in water using an ion chamber for various field sizes and depths. In case of virtual wedge device, as upper jaw moves during irradiation, wedge angles were estimated by accumulated doses. These measurements were performed at off-axis points perpendicular to the beam central axis in water for a 15 cm x 20 cm radiation field size at the depth of 10 cm. Surface does without and with virtual or physical wedges were measured using a parallel plate ion chamber at surface. Field size was 15 cm * 20 cm and a polystyrene phantom was used. For various field sizes, virtual and physical wedge factors were changed by maximum 2.1% and 3.9%, respectively. For various depths, virtual and physical wedge factors were changed by maximum 1.9% and 2.9%, respectively. No major difference was found between the virtual and physical wedge angles and the difference was within 0.5. Surface dose with physical wedge was reduced by maximum 20% (x-ray beam : 6 MV, wedge angle : 45, SSD : 80 cm) relative to one with virtual wedge or without wedge. Comparison of the characteristics of Siemens virtual wedge device with physical wedges was performed. Depth dependence of virtual wedge factor was smaller than that of physical wedge factor. Virtual and physical wedge factors were nearly independent of field sizes. The accuracy of virtual and physical wedge angles was excellent. Surface dose was found to be reduced using a physical wedge

  14. Physical characteristics comparison of virtual wedge device with physical wedge

    International Nuclear Information System (INIS)

    Choi, Dong Rak; Shin, Kyung Hwan; Lee, Kyu Chan; Kim, Dae Yong; Ahn, Yong Chan; Lim, Do Hoon; Kim, Moon Kyung; Huh, Seung Jae

    1999-01-01

    We have compared the characteristics of Siemens virtual wedge device with physical wedges for clinical application. We investigated the characteristics of virtual and physical wedges for various wedge angles (15, 30, 45, and 60 ) using 6- and 15MV photon beams. Wedge factors were measured in water using an ion chamber for various field sizes and depths. In case of virtual wedge device, as upper jaw moves during irradiation, wedge angles were estimated by accumulated doses. These measurements were performed at off-axis points perpendicular to the beam central axis in water for a 15 cm x 20 cm radiation field size at the depth of 10 cm. Surface doses without and with virtual or physical wedges were measured using a parallel plate ion chamber at surface. Field size was 15 cm x 20 cm and a polystyrene phantom was used. For various field sizes, virtual and physical wedge factors were changed by maximum 2.1% and 3.9%, respectively. For various depths, virtual and physical wedge factors were changed by maximum 1.9% and 2.9%, respectively. No major difference was found between the virtual and physical wedge angles and the difference was within 0.5 .deg. . Surface dose with physical wedge was reduced by maximum 20% (x-ray beam: 6 MV, wedge angle: 45 .deg. , SSD: 80cm) relative to one with virtual wedge or without wedge. Comparison of the characteristics of Siemens virtual wedge device with physical wedges was performed. Depth dependence of virtual wedge factor was smaller than that of physical wedge factor. Virtual and physical wedge factors were nearly independent of field sizes. The accuracy of virtual and physical wedge angles was excellent. Surface dose was found to be reduced using physical wedge

  15. HLM in Cluster-Randomised Trials--Measuring Efficacy across Diverse Populations of Learners

    Science.gov (United States)

    Hegedus, Stephen; Tapper, John; Dalton, Sara; Sloane, Finbarr

    2013-01-01

    We describe the application of Hierarchical Linear Modelling (HLM) in a cluster-randomised study to examine learning algebraic concepts and procedures in an innovative, technology-rich environment in the US. HLM is applied to measure the impact of such treatment on learning and on contextual variables. We provide a detailed description of such…

  16. A cluster-based randomized controlled trial promoting community participation in arsenic mitigation efforts in Bangladesh

    OpenAIRE

    George, Christine Marie; van Geen, Alexander; Slavkovich, Vesna; Singha, Ashit; Levy, Diane; Islam, Tariqul; Ahmed, Kazi Matin; Moon-Howard, Joyce; Tarozzi, Alessandro; Liu, Xinhua; Factor-Litvak, Pam; Graziano, Joseph

    2012-01-01

    Abstract Objective To reduce arsenic (As) exposure, we evaluated the effectiveness of training community members to perform water arsenic (WAs) testing and provide As education compared to sending representatives from outside communities to conduct these tasks. Methods We conducted a cluster based randomized controlled trial of 20 villages in Singair, Bangladesh. Fifty eligible respondents were randomly selected in each village. In 10 villages, a community member provided As education and WAs...

  17. Clinician-led improvement in cancer care (CLICC) - testing a multifaceted implementation strategy to increase evidence-based prostate cancer care: phased randomised controlled trial - study protocol

    Science.gov (United States)

    2014-01-01

    Background Clinical practice guidelines have been widely developed and disseminated with the aim of improving healthcare processes and patient outcomes but the uptake of evidence-based practice remains haphazard. There is a need to develop effective implementation methods to achieve large-scale adoption of proven innovations and recommended care. Clinical networks are increasingly being viewed as a vehicle through which evidence-based care can be embedded into healthcare systems using a collegial approach to agree on and implement a range of strategies within hospitals. In Australia, the provision of evidence-based care for men with prostate cancer has been identified as a high priority. Clinical audits have shown that fewer than 10% of patients in New South Wales (NSW) Australia at high risk of recurrence after radical prostatectomy receive guideline recommended radiation treatment following surgery. This trial will test a clinical network-based intervention to improve uptake of guideline recommended care for men with high-risk prostate cancer. Methods/Design In Phase I, a phased randomised cluster trial will test a multifaceted intervention that harnesses the NSW Agency for Clinical Innovation (ACI) Urology Clinical Network to increase evidence-based care for men with high-risk prostate cancer following surgery. The intervention will be introduced in nine NSW hospitals over 10 months using a stepped wedge design. Outcome data (referral to radiation oncology for discussion of adjuvant radiotherapy in line with guideline recommended care or referral to a clinical trial of adjuvant versus salvage radiotherapy) will be collected through review of patient medical records. In Phase II, mixed methods will be used to identify mechanisms of provider and organisational change. Clinicians’ knowledge and attitudes will be assessed through surveys. Process outcome measures will be assessed through document review. Semi-structured interviews will be conducted to elucidate

  18. Effectiveness and cost-effectiveness of a physical activity loyalty scheme for behaviour change maintenance: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Ruth F. Hunter

    2016-07-01

    Full Text Available Abstract Background Increasing physical activity in the workplace can provide employee physical and mental health benefits, and employer economic benefits through reduced absenteeism and increased productivity. The workplace is an opportune setting to encourage habitual activity. However, there is limited evidence on effective behaviour change interventions that lead to maintained physical activity. This study aims to address this gap and help build the necessary evidence base for effective, and cost-effective, workplace interventions. Methods/design This cluster randomised control trial will recruit 776 office-based employees from public sector organisations in Belfast and Lisburn city centres, Northern Ireland. Participants will be randomly allocated by cluster to either the Intervention Group or Control Group (waiting list control. The 6-month intervention consists of rewards (retail vouchers, based on similar principles to high street loyalty cards, feedback and other evidence-based behaviour change techniques. Sensors situated in the vicinity of participating workplaces will promote and monitor minutes of physical activity undertaken by participants. Both groups will complete all outcome measures. The primary outcome is steps per day recorded using a pedometer (Yamax Digiwalker CW-701 for 7 consecutive days at baseline, 6, 12 and 18 months. Secondary outcomes include health, mental wellbeing, quality of life, work absenteeism and presenteeism, and use of healthcare resources. Process measures will assess intervention “dose”, website usage, and intervention fidelity. An economic evaluation will be conducted from the National Health Service, employer and retailer perspective using both a cost-utility and cost-effectiveness framework. The inclusion of a discrete choice experiment will further generate values for a cost-benefit analysis. Participant focus groups will explore who the intervention worked for and why, and interviews with

  19. Effectiveness and cost-effectiveness of a physical activity loyalty scheme for behaviour change maintenance: a cluster randomised controlled trial.

    Science.gov (United States)

    Hunter, Ruth F; Brennan, Sarah F; Tang, Jianjun; Smith, Oliver J; Murray, Jennifer; Tully, Mark A; Patterson, Chris; Longo, Alberto; Hutchinson, George; Prior, Lindsay; French, David P; Adams, Jean; McIntosh, Emma; Kee, Frank

    2016-07-22

    Increasing physical activity in the workplace can provide employee physical and mental health benefits, and employer economic benefits through reduced absenteeism and increased productivity. The workplace is an opportune setting to encourage habitual activity. However, there is limited evidence on effective behaviour change interventions that lead to maintained physical activity. This study aims to address this gap and help build the necessary evidence base for effective, and cost-effective, workplace interventions. This cluster randomised control trial will recruit 776 office-based employees from public sector organisations in Belfast and Lisburn city centres, Northern Ireland. Participants will be randomly allocated by cluster to either the Intervention Group or Control Group (waiting list control). The 6-month intervention consists of rewards (retail vouchers, based on similar principles to high street loyalty cards), feedback and other evidence-based behaviour change techniques. Sensors situated in the vicinity of participating workplaces will promote and monitor minutes of physical activity undertaken by participants. Both groups will complete all outcome measures. The primary outcome is steps per day recorded using a pedometer (Yamax Digiwalker CW-701) for 7 consecutive days at baseline, 6, 12 and 18 months. Secondary outcomes include health, mental wellbeing, quality of life, work absenteeism and presenteeism, and use of healthcare resources. Process measures will assess intervention "dose", website usage, and intervention fidelity. An economic evaluation will be conducted from the National Health Service, employer and retailer perspective using both a cost-utility and cost-effectiveness framework. The inclusion of a discrete choice experiment will further generate values for a cost-benefit analysis. Participant focus groups will explore who the intervention worked for and why, and interviews with retailers will elucidate their views on the sustainability

  20. The Effect of Brief Interventions on the Drinking Behaviour of Pregnant Women in a High-Risk Rural South African Community: A Cluster Randomised Trial

    Science.gov (United States)

    Marais, Sandra; Jordaan, Esme; Viljoen, Dennis; Olivier, Leana; de Waal, Johanna; Poole, Caroline

    2011-01-01

    The purpose of this paper is to assess the impact of a series of brief interventions (BIs) on anti-natal alcohol consumption of women from a disadvantaged and high-risk background attending state health clinics in a rural district, Western Cape Province, South Africa. A pragmatic cluster randomised trial design was followed. All pregnant women,…

  1. Effect of mobile application-based versus DVD-based CPR training on students’ practical CPR skills and willingness to act: a cluster randomised study

    Science.gov (United States)

    Nord, Anette; Svensson, Leif; Hult, Håkan; Kreitz-Sandberg, Susanne; Nilsson, Lennart

    2016-01-01

    Objectives The aim was to compare students’ practical cardiopulmonary resuscitation (CPR) skills and willingness to perform bystander CPR, after a 30 min mobile application (app)-based versus a 50 min DVD-based training. Settings Seventh grade students in two Swedish municipalities. Design A cluster randomised trial. The classes were randomised to receive app-based or DVD-based training. Willingness to act and practical CPR skills were assessed, directly after training and at 6 months, by using a questionnaire and a PC Skill Reporting System. Data on CPR skills were registered in a modified version of the Cardiff test, where scores were given in 12 different categories, adding up to a total score of 12–48 points. Training and measurements were performed from December 2013 to October 2014. Participants 63 classes or 1232 seventh grade students (13-year-old) were included in the study. Primary and secondary outcome measures Primary end point was the total score of the modified Cardiff test. The individual variables of the test and self-reported willingness to make a life-saving intervention were secondary end points. Results The DVD-based group was superior to the app-based group in CPR skills; a total score of 36 (33–38) vs 33 (30–36) directly after training (pCPR skill components. Both groups improved compression depth from baseline to follow-up. If a friend suffered cardiac arrest, 78% (DVD) versus 75% (app) would do compressions and ventilations, whereas only 31% (DVD) versus 32% (app) would perform standard CPR if the victim was a stranger. Conclusions At 6 months follow-up, the 50 min DVD-based group showed superior CPR skills compared with the 30 min app-based group. The groups did not differ in regard to willingness to make a life-saving effort. PMID:27130166

  2. Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring vaccination, open-label, cluster-randomised trial (Ebola Ça Suffit!).

    Science.gov (United States)

    Henao-Restrepo, Ana Maria; Camacho, Anton; Longini, Ira M; Watson, Conall H; Edmunds, W John; Egger, Matthias; Carroll, Miles W; Dean, Natalie E; Diatta, Ibrahima; Doumbia, Moussa; Draguez, Bertrand; Duraffour, Sophie; Enwere, Godwin; Grais, Rebecca; Gunther, Stephan; Gsell, Pierre-Stéphane; Hossmann, Stefanie; Watle, Sara Viksmoen; Kondé, Mandy Kader; Kéïta, Sakoba; Kone, Souleymane; Kuisma, Eewa; Levine, Myron M; Mandal, Sema; Mauget, Thomas; Norheim, Gunnstein; Riveros, Ximena; Soumah, Aboubacar; Trelle, Sven; Vicari, Andrea S; Røttingen, John-Arne; Kieny, Marie-Paule

    2017-02-04

    rVSV-ZEBOV is a recombinant, replication competent vesicular stomatitis virus-based candidate vaccine expressing a surface glycoprotein of Zaire Ebolavirus. We tested the effect of rVSV-ZEBOV in preventing Ebola virus disease in contacts and contacts of contacts of recently confirmed cases in Guinea, west Africa. We did an open-label, cluster-randomised ring vaccination trial (Ebola ça Suffit!) in the communities of Conakry and eight surrounding prefectures in the Basse-Guinée region of Guinea, and in Tomkolili and Bombali in Sierra Leone. We assessed the efficacy of a single intramuscular dose of rVSV-ZEBOV (2×10 7 plaque-forming units administered in the deltoid muscle) in the prevention of laboratory confirmed Ebola virus disease. After confirmation of a case of Ebola virus disease, we definitively enumerated on a list a ring (cluster) of all their contacts and contacts of contacts including named contacts and contacts of contacts who were absent at the time of the trial team visit. The list was archived, then we randomly assigned clusters (1:1) to either immediate vaccination or delayed vaccination (21 days later) of all eligible individuals (eg, those aged ≥18 years and not pregnant, breastfeeding, or severely ill). An independent statistician generated the assignment sequence using block randomisation with randomly varying blocks, stratified by location (urban vs rural) and size of rings (≤20 individuals vs >20 individuals). Ebola response teams and laboratory workers were unaware of assignments. After a recommendation by an independent data and safety monitoring board, randomisation was stopped and immediate vaccination was also offered to children aged 6-17 years and all identified rings. The prespecified primary outcome was a laboratory confirmed case of Ebola virus disease with onset 10 days or more from randomisation. The primary analysis compared the incidence of Ebola virus disease in eligible and vaccinated individuals assigned to immediate

  3. The Happy Life Club™ study protocol: A cluster randomised controlled trial of a type 2 diabetes health coach intervention

    Directory of Open Access Journals (Sweden)

    Yang Hui

    2011-02-01

    Full Text Available Abstract Background The Happy Life Club™ is an intervention that utilises health coaches trained in behavioural change and motivational interviewing techniques to assist with the management of type 2 diabetes mellitus (T2DM in primary care settings in China. Health coaches will support participants to improve modifiable risk factors and adhere to effective self-management treatments associated with T2DM. Methods/Design A cluster randomised controlled trial involving 22 Community Health Centres (CHCs in Fengtai District of Beijing, China. CHCs will be randomised into a control or intervention group, facilitating recruitment of at least 1320 individual participants with T2DM into the study. Participants in the intervention group will receive a combination of both telephone and face-to-face health coaching over 18 months, in addition to usual care received by the control group. Health coaching will be performed by CHC doctors and nurses certified in coach-assisted chronic disease management. Outcomes will be assessed at baseline and again at 6, 12 and 18 months by means of a clinical health check and self-administered questionnaire. The primary outcome measure is HbA1c level. Secondary outcomes include metabolic, physiological and psychological variables. Discussion This cluster RCT has been developed to suit the Chinese health care system and will contribute to the evidence base for the management of patients with T2DM. With a strong focus on self-management and health coach support, the study has the potential to be adapted to other chronic diseases, as well as other regions of China. Trial Registration Current Controlled Trials ISRCTN01010526

  4. Does Interpersonal Psychotherapy improve clinical care for adolescents with depression attending a rural child and adolescent mental health service? Study protocol for a cluster randomised feasibility trial

    Directory of Open Access Journals (Sweden)

    Villanueva Elmer V

    2007-10-01

    Full Text Available Abstract Background Depression amongst adolescents is a costly societal problem. Little research documents the effectiveness of public mental health services in mapping this problem. Further, it is not clear whether usual care in such services can be improved via clinician training in a relevant evidence based intervention. One such intervention, found to be effective and easily learned amongst novice clinicians, is Interpersonal Psychotherapy (IPT. The study described in the current paper has two main objectives. First, it aims to investigate the impact on clinical care of implementing Interpersonal Psychotherapy for Adolescents for the treatment of adolescent depression within a rural mental health service compared with Treatment as Usual (TAU. The second objective is to record the process and challenges (i.e. feasibility, acceptability, sustainability associated with implementing and evaluating an evidence-based intervention within a community service. This paper outlines the study rationale and design for this community based research trial. Methods/design The study involves a cluster randomisation trial to be conducted within a Child and Adolescent Mental Health Service in rural Australia. All clinicians in the service will be invited to participate. Participating clinicians will be randomised via block design at each of four sites to (a training and delivery of IPT, or (b TAU. The primary measure of impact on care will be a clinically significant change in depressive symptomatology, with secondary outcomes involving treatment satisfaction and changes in other symptomatology. Participating adolescents with significant depressive symptomatology, aged 12 to 18 years, will complete assessment measures at Weeks 0, 12 and 24 of treatment. They will also complete a depression inventory once a month during that period. This study aims to recruit 60 adolescent participants and their parent/guardian/s. A power analysis is not indicated as an intra

  5. Evaluation of a structured goal planning and tailored follow-up programme in rehabilitation for patients with rheumatic diseases: protocol for a pragmatic, stepped-wedge cluster randomized trial

    Science.gov (United States)

    2014-01-01

    Background Comprehensive rehabilitation, involving health professionals from various disciplines, is widely used as an adjunct to pharmacological and surgical treatment in people with rheumatic diseases. However, the evidence for the clinical- and cost-effectiveness of such interventions is limited, and the majority of those who receive rehabilitation are back to their initial health status six to 12 months after discharge. Methods/design To evaluate the goal attainment, health effects and cost-effectiveness of a new rehabilitation programme compared to current traditional rehabilitation programmes for people with rheumatic diseases, a stepped-wedge cluster randomized trial will be performed. Patients admitted for rehabilitation at six centres in the south-eastern part of Norway will be invited to participate. In the trial, six participating centres will switch from a control (current rehabilitation programme) to an intervention phase (the new rehabilitation programme) in a randomized order. Supported by recent research, the new programme will be a supplement to the existing programme at each centre, and will comprise four elements designed to enhance and support lifestyle changes introduced in the rehabilitation period: structured goal-planning, motivational interviewing, a self-help booklet and four follow-up telephone calls during the first five months following discharge. The primary outcome will be health-related quality of life and goal attainment, as measured by the Patient Generated Index directly before and after the rehabilitation stay, as well as after six and 12 months. Secondary outcomes will include self-reported pain, fatigue, a global assessment of disease activity and motivation for change (measured on 11-point numeric ratings scales), health-related quality of life as measured by the Short Form 36 Health Survey (SF-36) and utility assessed by the SF6D utility index. The main analysis will be on an intention to treat basis and will assess the

  6. Poor uptake of an online intervention in a cluster randomised controlled trial of online diabetes education for rural general practitioners.

    Science.gov (United States)

    Paul, Christine L; Piterman, Leon; Shaw, Jonathan E; Kirby, Catherine; Forshaw, Kristy L; Robinson, Jennifer; Thepwongsa, Isaraporn; Sanson-Fisher, Robert W

    2017-03-23

    In Australia, rural and remote communities have high rates of diabetes-related death and hospitalisation. General practitioners (GPs) play a major role in diabetes detection and management. Education of GPs could optimise diabetes management and improve patient outcomes at a population level. The study aimed to describe the uptake of a continuing medical education intervention for rural GPs and its impact on the viability of a cluster randomised controlled trial of the effects of continuing medical education on whole-town diabetes monitoring and control. Trial design: the cluster randomised controlled trial involved towns as the unit of allocation and analysis with outcomes assessed by de-identified pathology data (not reported here). The intervention programme consisted of an online active learning module, direct electronic access to specialist advice and performance feedback. Multiple rounds of invitation were used to engage GPs with the online intervention content. Evidence-based strategies (e.g. pre-notification, rewards, incentives) were incorporated into the invitations to enrol in the programme. Recruitment to the programme was electronically monitored through the hosting software package during the study intervention period. Eleven matched pairs of towns were included in the study. There were 146 GPs in the 11 intervention towns, of whom 34 (23.3%) enrolled in the programme, and 8 (5.5%) completed the online learning module. No town had more than 10% of the resident GPs complete the learning module. There were no contacts made by GPs regarding requests for specialist advice. Consequently, the trial was discontinued. There is an ongoing need to engage primary care physicians in improving diabetes monitoring and management in rural areas. Online training options, while notionally attractive and accessible, are not likely to have high levels of uptake, even when evidence-based recruitment strategies are implemented. Australian New Zealand Clinical Trials

  7. Comparison of microbial community shifts in two parallel multi-step drinking water treatment processes.

    Science.gov (United States)

    Xu, Jiajiong; Tang, Wei; Ma, Jun; Wang, Hong

    2017-07-01

    Drinking water treatment processes remove undesirable chemicals and microorganisms from source water, which is vital to public health protection. The purpose of this study was to investigate the effects of treatment processes and configuration on the microbiome by comparing microbial community shifts in two series of different treatment processes operated in parallel within a full-scale drinking water treatment plant (DWTP) in Southeast China. Illumina sequencing of 16S rRNA genes of water samples demonstrated little effect of coagulation/sedimentation and pre-oxidation steps on bacterial communities, in contrast to dramatic and concurrent microbial community shifts during ozonation, granular activated carbon treatment, sand filtration, and disinfection for both series. A large number of unique operational taxonomic units (OTUs) at these four treatment steps further illustrated their strong shaping power towards the drinking water microbial communities. Interestingly, multidimensional scaling analysis revealed tight clustering of biofilm samples collected from different treatment steps, with Nitrospira, the nitrite-oxidizing bacteria, noted at higher relative abundances in biofilm compared to water samples. Overall, this study provides a snapshot of step-to-step microbial evolvement in multi-step drinking water treatment systems, and the results provide insight to control and manipulation of the drinking water microbiome via optimization of DWTP design and operation.

  8. A community-based cluster randomised controlled trial to evaluate the effectiveness of different bundles of nutrition-specific interventions in improving mean length-for-age z score among children at 24 months of age in rural Bangladesh: study protocol

    Directory of Open Access Journals (Sweden)

    Sk Masum Billah

    2017-05-01

    Full Text Available Abstract Background Prevalence of stunting among under-five children in Bangladesh is 36%, varying with geographic and socio-economic characteristics. Previously, research groups statistically modelled the effect of 10 individual nutrition-specific interventions targeting the critical first 1000 days of life from conception, on lives saved and costs incurred in countries with the highest burden of stunted children. However, primary research on the combined effects of these interventions is limited. Our study directly addresses this gap by examining the effect of combinations of 5 preventive interventions on length-for-age z-scores (LAZ among 2-years old children. Methods This community-based cluster randomised trial (c-RCT compares 4 intervention combinations against one comparison arm. Intervention combinations are: 1 Behaviour change communication (BCC on maternal nutrition during pregnancy, exclusive breastfeeding, and complementary feeding, along with prenatal nutritional supplement (PNS and complementary food supplement (CFS; 2 BCC with PNS; 3 BCC with CFS; and 4 BCC alone. The comparison arm receives only routine health and nutrition services. From a rural district, 125 clusters were selected and randomly assigned to any one of the five study arms by block randomisation. A bespoke automated tab-based system was developed linking data collection, intervention delivery and project supervision. Total sample size is 1500 pregnant women, with minimum 1050 resultant children expected to be retained, powered to detect a difference of at least 0.4 in the mean LAZ score of children at 24 months, the main outcome variable, between the comparison arm and each intervention arm. Length and other anthropometric measurements, nutritional intake and other relevant data on mother and children are being collected during enrolment, twice during pregnancy, postpartum monthly till 6 months, and every third month thereafter till 24 months. Discussion This c

  9. Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial.

    Science.gov (United States)

    Brinkman, Sally A; Johnson, Sarah E; Lawrence, David; Codde, James P; Hart, Michael B; Straton, Judith A Y; Silburn, Sven

    2010-10-21

    This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP) program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Fifty-seven schools (86% of 66 eligible secondary schools) in Perth, Australia were recruited to the clustered (by school) randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms. This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide Infant Simulator based programs in school settings. ISRCTN24952438.

  10. Rational and design of a stepped-wedge cluster randomized trial evaluating quality improvement initiative for reducing cardiovascular events among patients with acute coronary syndromes in resource-constrained hospitals in China.

    Science.gov (United States)

    Li, Shenshen; Wu, Yangfeng; Du, Xin; Li, Xian; Patel, Anushka; Peterson, Eric D; Turnbull, Fiona; Lo, Serigne; Billot, Laurent; Laba, Tracey; Gao, Runlin

    2015-03-01

    Acute coronary syndromes (ACSs) are a major cause of morbidity and mortality, yet effective ACS treatments are frequently underused in clinical practice. Randomized trials including the CPACS-2 study suggest that quality improvement initiatives can increase the use of effective treatments, but whether such programs can impact hard clinical outcomes has never been demonstrated in a well-powered randomized controlled trial. The CPACS-3 study is a stepped-wedge cluster-randomized trial conducted in 104 remote level 2 hospitals without PCI facilities in China. All hospitalized ACS patients will be recruited consecutively over a 30-month period to an anticipated total study population of more than 25,000 patients. After a 6-month baseline period, hospitals will be randomized to 1 of 4 groups, and a 6-component quality improvement intervention will be implemented sequentially in each group every 6months. These components include the following: establishment of a quality improvement team, implementation of a clinical pathway, training of physicians and nurses, hospital performance audit and feedback, online technical support, and patient education. All patients will be followed up for 6months postdischarge. The primary outcome will be the incidence of in-hospital major adverse cardiovascular events comprising all-cause mortality, myocardial infarction or reinfarction, and nonfatal stroke. The CPACS-3 study will be the first large randomized trial with sufficient power to assess the effects of a multifaceted quality of care improvement initiative on hard clinical outcomes, in patients with ACS. Copyright © 2014 Elsevier Inc. All rights reserved.

  11. LifeSteps: An Evidence-based Health Promotion Program for Underserved Populations – A Community Service Learning Approach

    Directory of Open Access Journals (Sweden)

    Melanie Austin-McCain

    2015-04-01

    Full Text Available Chronic diseases are the most common, costly, and preventable of all health problems in the United States. Chronic diseases represent the leading causes of death and are experienced at higher rates by minority populations (CDC, 2012. Innovative community-based health promotion programs are recommended that meet the diverse needs of underserved populations (Yeary, et al., 2011. LifeSteps is being developed as an evidence-based health promotion program focusing on health and wellness, a domain area defined within the Occupational Therapy Practice Framework (OTPF, 2008. LifeSteps will utilize a client-centered approach to coach individuals in making health behavior changes. Fieldwork and service-learning components are incorporated integrating clinical practice, academic study, and collaboration with community providers. Program evaluation measures based on the Transtheoretical Model (TTM have been identified to address all phases of program planning. The LifeSteps health promotion program aligns with local, national, and international objectives and addresses the need for programs that meet the diverse needs of underserved populations. Occupational therapists are in a unique position for implementing community-based interventions that promote health and contribute to a healthier society.

  12. Improving educational achievement and anaemia of school children: design of a cluster randomised trial of school-based malaria prevention and enhanced literacy instruction in Kenya

    Directory of Open Access Journals (Sweden)

    Halliday Katherine E

    2010-10-01

    Full Text Available Abstract Background Improving the health of school-aged children can yield substantial benefits for cognitive development and educational achievement. However, there is limited experimental evidence on the benefits of school-based malaria prevention or how health interventions interact with other efforts to improve education quality. This study aims to evaluate the impact of school-based malaria prevention and enhanced literacy instruction on the health and educational achievement of school children in Kenya. Design A factorial, cluster randomised trial is being implemented in 101 government primary schools on the coast of Kenya. The interventions are (i intermittent screening and treatment of malaria in schools by public health workers and (ii training workshops and support for teachers to promote explicit and systematic literacy instruction. Schools are randomised to one of four groups: receiving either (i the malaria intervention alone; (ii the literacy intervention alone; (iii both interventions combined; or (iv control group where neither intervention is implemented. Children from classes 1 and 5 are randomly selected and followed up for 24 months. The primary outcomes are educational achievement and anaemia, the hypothesised mediating variables through which education is affected. Secondary outcomes include malaria parasitaemia, school attendance and school performance. A nested process evaluation, using semi-structured interviews, focus group discussion and a stakeholder analysis will investigate the community acceptability, feasibility and cost-effectiveness of the interventions. Discussion Across Africa, governments are committed to improve health and education of school-aged children, but seek clear policy and technical guidance as to the optimal approach to address malaria and improved literacy. This evaluation will be one of the first to simultaneously evaluate the impact of health and education interventions in the improvement of

  13. A theory-based implementation program for alcohol screening and brief intervention (ASBI) in general practices: Planned development and study protocol of a cluster randomised controlled trial.

    Science.gov (United States)

    Abidi, L; Oenema, A; Candel, M J J M; van de Mheen, D

    2016-11-01

    Previous studies have shown that alcohol screening and brief intervention (ASBI) in general practices can lead to significant reductions in alcohol consumption among patients, yet ASBI is rarely implemented into routine clinical practice. The aim of this paper is to describe the development and evaluation of an ASBI implementation program aimed at increasing ASBI delivery rates of general practitioners (GPs) and decreasing patients' alcohol consumption. This study protocol describes the step-wise development and evaluation of an ASBI implementation program. A four-step method is used to identify relevant determinants of change and intervention components based on the Behaviour Change Wheel and the Theoretical Domains Framework. The program will be evaluated in general practices in The Netherlands in a two-arm cluster randomised controlled trial which investigates the effect of the program on GPs' ASBI delivery behaviour as well as on patients' alcohol consumption. Effective theory- and practice-based strategies to implement ASBI in general practices are highly needed. Using a stepwise method we described the development of a program consisting of an e-learning module, a tailored feedback module and environmental support and materials. We hypothesize that this program will result in an increase of GPs' ASBI delivery behaviour. Secondly, we expect an overall decrease in percentage of patients with excessive or problematic alcohol use and a higher proportion of patients from GPs receiving the ASBI implementation program decreasing their alcohol consumption, compared to patients from GPs in the control group. NTR5539. Copyright © 2016 Elsevier Inc. All rights reserved.

  14. Study protocol for the SMART2D adaptive implementation trial: a cluster randomised trial comparing facility-only care with integrated facility and community care to improve type 2 diabetes outcomes in Uganda, South Africa and Sweden.

    Science.gov (United States)

    Guwatudde, David; Absetz, Pilvikki; Delobelle, Peter; Östenson, Claes-Göran; Olmen Van, Josefien; Alvesson, Helle Molsted; Mayega, Roy William; Ekirapa Kiracho, Elizabeth; Kiguli, Juliet; Sundberg, Carl Johan; Sanders, David; Tomson, Göran; Puoane, Thandi; Peterson, Stefan; Daivadanam, Meena

    2018-03-17

    Type 2 diabetes (T2D) is increasingly contributing to the global burden of disease. Health systems in most parts of the world are struggling to diagnose and manage T2D, especially in low-income and middle-income countries, and among disadvantaged populations in high-income countries. The aim of this study is to determine the added benefit of community interventions onto health facility interventions, towards glycaemic control among persons with diabetes, and towards reduction in plasma glucose among persons with prediabetes. An adaptive implementation cluster randomised trial is being implemented in two rural districts in Uganda with three clusters per study arm, in an urban township in South Africa with one cluster per study arm, and in socially disadvantaged suburbs in Stockholm, Sweden with one cluster per study arm. Clusters are communities within the catchment areas of participating primary healthcare facilities. There are two study arms comprising a facility plus community interventions arm and a facility-only interventions arm. Uganda has a third arm comprising usual care. Intervention strategies focus on organisation of care, linkage between health facility and the community, and strengthening patient role in self-management, community mobilisation and a supportive environment. Among T2D participants, the primary outcome is controlled plasma glucose; whereas among prediabetes participants the primary outcome is reduction in plasma glucose. The study has received approval in Uganda from the Higher Degrees, Research and Ethics Committee of Makerere University School of Public Health and from the Uganda National Council for Science and Technology; in South Africa from the Biomedical Science Research Ethics Committee of the University of the Western Cape; and in Sweden from the Regional Ethical Board in Stockholm. Findings will be disseminated through peer-reviewed publications and scientific meetings. ISRCTN11913581; Pre-results. © Article author(s) (or their

  15. Impulsive Cluster Synchronization in Community Network with Nonidentical Nodes

    International Nuclear Information System (INIS)

    Deng Liping; Wu Zhaoyan

    2012-01-01

    In this paper, cluster synchronization in community network with nonidentical nodes and impulsive effects is investigated. Community networks with two kinds of topological structure are investigated. Positive weighted network is considered first and external pinning controllers are designed for achieving cluster synchronization. Cooperative and competitive network under some assumptions is investigated as well and can achieve cluster synchronization with only impulsive controllers. Based on the stability analysis of impulsive differential equation and the Lyapunov stability theory, several simple and useful synchronization criteria are derived. Finally, numerical simulations are provided to verify the effectiveness of the derived results.

  16. Dental care resistance prevention and antibiotic prescribing modification-the cluster-randomised controlled DREAM trial.

    Science.gov (United States)

    Löffler, Christin; Böhmer, Femke; Hornung, Anne; Lang, Hermann; Burmeister, Ulrike; Podbielski, Andreas; Wollny, Anja; Kundt, Günther; Altiner, Attila

    2014-02-22

    Bacterial resistance development is one of the most urgent problems in healthcare worldwide. In Europe, dentistry accounts for a comparatively high amount of antibiotic prescriptions. In light of increasing levels of bacterial resistance, this development is alarming. So far, very few interventional studies have been performed, and further research is urgently needed. By means of a complex educational intervention, the DREAM trial aims at optimising antibiotic prescribing behaviour of general dentists in Germany. This is a cluster-randomised controlled trial, where each cluster consists of one dental practice and all of its patients in a defined period. Participants are general dentists practicing in the German region of Mecklenburg-Western Pomerania. Randomisation takes place after baseline data collection (6 months) and will be stratified by the antibiotic prescribing rates of the participating dental practices. Dentists randomised into the intervention group will participate in a complex small group educational seminar that aims at: increasing knowledge on bacterial resistance, pharmacology, and prophylaxis of infectious endocarditis; increasing awareness of dentist-patient communication using video-taped vignettes of dentist-patient communication on antibiotic treatment; improving collaboration between general dentists, general practitioners, and practice-based cardiologists on the necessity of antibiotic prophylaxis; enhancing awareness of the dentists' own prescribing habits by providing antibiotic prescribing feedback; and increasing patient knowledge on antibiotic treatment by providing patient-centred information material on antibiotic prophylaxis of endocarditis. The dentists randomised into the control group will not receive any educational programme and provide care as usual. Primary outcome is the overall antibiotic prescribing rate measured at T1 (period of six months after intervention). In a subgroup of adult patients affected by odontogenic

  17. Managing Injuries of the Neck Trial (MINT): design of a randomised controlled trial of treatments for whiplash associated disorders

    Science.gov (United States)

    Lamb, Sarah E; Gates, Simon; Underwood, Martin R; Cooke, Matthew W; Ashby, Deborah; Szczepura, Ala; Williams, Mark A; Williamson, Esther M; Withers, Emma J; Mt Isa, Shahrul; Gumber, Anil

    2007-01-01

    Background A substantial proportion of patients with whiplash injuries develop chronic symptoms. However, the best treatment of acute injuries to prevent long-term problems is uncertain. A stepped care treatment pathway has been proposed, in which patients are given advice and education at their initial visit to the emergency department (ED), followed by review at three weeks and physiotherapy for those with persisting symptoms. MINT is a two-stage randomised controlled trial to evaluate two components of such a pathway: 1. use of The Whiplash Book versus usual advice when patients first attend the emergency department; 2. referral to physiotherapy versus reinforcement of advice for patients with continuing symptoms at three weeks. Methods Evaluation of the Whiplash Book versus usual advice uses a cluster randomised design in emergency departments of eight NHS Trusts. Eligible patients are identified by clinicians in participating emergency departments and are sent a study questionnaire within a week of their ED attendance. Three thousand participants will be included. Patients with persisting symptoms three weeks after their ED attendance are eligible to join an individually randomised study of physiotherapy versus reinforcement of the advice given in ED. Six hundred participants will be randomised. Follow-up is at 4, 8 and 12 months after their ED attendance. Primary outcome is the Neck Disability Index (NDI), and secondary outcomes include quality of life and time to return to work and normal activities. An economic evaluation is being carried out. Conclusion This paper describes the protocol and operational aspects of a complex intervention trial based in NHS emergency and physiotherapy departments, evaluating two components of a stepped-care approach to the treatment of whiplash injuries. The trial uses two randomisations, with the first stage being cluster randomised and the second individually randomised. PMID:17257408

  18. Re-estimating sample size in cluster randomized trials with active recruitment within clusters

    NARCIS (Netherlands)

    van Schie, Sander; Moerbeek, Mirjam

    2014-01-01

    Often only a limited number of clusters can be obtained in cluster randomised trials, although many potential participants can be recruited within each cluster. Thus, active recruitment is feasible within the clusters. To obtain an efficient sample size in a cluster randomised trial, the cluster

  19. The effect of a complementary e-learning course on implementation of a quality improvement project regarding care for elderly patients: a stepped wedge trial.

    Science.gov (United States)

    Van de Steeg, Lotte; Langelaan, Maaike; Ijkema, Roelie; Wagner, Cordula

    2012-03-02

    Delirium occurs frequently in elderly hospitalised patients and is associated with higher mortality, increased length of hospital stay, functional decline, and admission to long-term care. Healthcare professionals frequently do not recognise delirium, indicating that education can play an important role in improving delirium care for hospitalised elderly. Previous studies have indicated that e-learning can provide an effective way of educating healthcare professionals and improving quality of care, though results are inconsistent. This stepped wedge cluster randomised trial will assess the effects of a complementary delirium e-learning course on the implementation of quality improvement initiative, which aims to enhance the recognition and management of delirium in elderly patients. The trial will be conducted in 18 Dutch hospitals and last 11 months. Measurements will be taken in all participating wards using monthly record reviews, in order to monitor delivered care. These measurements will include the percentage of elderly patients who were screened for the risk of developing delirium, use of the Delirium Observation Screening scale, use of nursing or medical interventions, and the percentage of elderly patients who were diagnosed with delirium. Data regarding the e-learning course will be gathered as well. These data will include user characteristics, information regarding use of the course, delirium knowledge before and after using the course, and the attitude and intentions of nurses concerning delirium care. The study will be conducted in internal medicine and surgical wards of eighteen hospitals that are at the beginning stages of implementing the Frail Elderly Project in the Netherlands. Better recognition of elderly patients at risk for delirium and subsequent care is expected from the introduction of an e-learning course for nurses that is complementary to an existing quality improvement project. This trial has the potential to demonstrate that e

  20. The effect of a complementary e-learning course on implementation of a quality improvement project regarding care for elderly patients: a stepped wedge trial

    Directory of Open Access Journals (Sweden)

    Van de Steeg Lotte

    2012-03-01

    Full Text Available Abstract Background Delirium occurs frequently in elderly hospitalised patients and is associated with higher mortality, increased length of hospital stay, functional decline, and admission to long-term care. Healthcare professionals frequently do not recognise delirium, indicating that education can play an important role in improving delirium care for hospitalised elderly. Previous studies have indicated that e-learning can provide an effective way of educating healthcare professionals and improving quality of care, though results are inconsistent. Methods and design This stepped wedge cluster randomised trial will assess the effects of a complementary delirium e-learning course on the implementation of quality improvement initiative, which aims to enhance the recognition and management of delirium in elderly patients. The trial will be conducted in 18 Dutch hospitals and last 11 months. Measurements will be taken in all participating wards using monthly record reviews, in order to monitor delivered care. These measurements will include the percentage of elderly patients who were screened for the risk of developing delirium, use of the Delirium Observation Screening scale, use of nursing or medical interventions, and the percentage of elderly patients who were diagnosed with delirium. Data regarding the e-learning course will be gathered as well. These data will include user characteristics, information regarding use of the course, delirium knowledge before and after using the course, and the attitude and intentions of nurses concerning delirium care. Setting The study will be conducted in internal medicine and surgical wards of eighteen hospitals that are at the beginning stages of implementing the Frail Elderly Project in the Netherlands. Discussion Better recognition of elderly patients at risk for delirium and subsequent care is expected from the introduction of an e-learning course for nurses that is complementary to an existing quality

  1. A practical method to calculate head scatter factors in wedged rectangular and irregular MLC shaped beams for external and internal wedges

    International Nuclear Information System (INIS)

    Georg, Dietmar; Olofsson, Joergen; Kuenzler, Thomas; Aiginger, Hannes; Karlsson, Mikael

    2004-01-01

    Factor based methods for absorbed dose or monitor unit calculations are often based on separate data sets for open and wedged beams. The determination of basic beam parameters can be rather time consuming, unless equivalent square methods are applied. When considering irregular wedged beams shaped with a multileaf collimator, parametrization methods for dosimetric quantities, e.g. output ratios or wedge factors as a function of field size and shape, become even more important. A practical method is presented to derive wedged output ratios in air (S c,w ) for any rectangular field and for any irregular MLC shaped beam. This method was based on open field output ratios in air (S c ) for a field with the same collimator setting, and a relation f w between S c,w and S c . The relation f w can be determined from measured output ratios in air for a few open and wedged fields including the maximum wedged field size. The function f w and its parametrization were dependent on wedge angle and treatment head design, i.e. they were different for internal and external wedges. The proposed method was tested for rectangular wedged fields on three accelerators with internal wedges (GE, Elekta, BBC) and two accelerators with external wedges (Varian). For symmetric regular beams the average deviation between calculated and measured S c,w /S c ratios was 0.3% for external wedges and about 0.6% for internal wedges. Maximum deviations of 1.8% were obtained for elongated rectangular fields on the GE and ELEKTA linacs with an internal wedge. The same accuracy was achieved for irregular MLC shaped wedged beams on the accelerators with MLC and internal wedges (GE and Elekta), with an average deviation <1% for the fields tested. The proposed method to determine output ratios in air for wedged beams from output ratios of open beams, combined with equivalent square approaches, can be easily integrated in empirical or semi-empirical methods for monitor unit calculations

  2. Protocol for the Northern Manhattan Diabetes Community Outreach Project. A randomised trial of a community health worker intervention to improve diabetes care in Hispanic adults.

    Science.gov (United States)

    Palmas, Walter; Teresi, Jeanne A; Findley, Sally; Mejia, Miriam; Batista, Milagros; Kong, Jian; Silver, Stephanie; Luchsinger, Jose A; Carrasquillo, Olveen

    2012-01-01

    Hispanics in the USA are affected by the diabetes epidemic disproportionately, and they consistently have lower access to care, poorer control of the disease and higher risk of complications. This study evaluates whether a community health worker (CHW) intervention may improve clinically relevant markers of diabetes care in adult underserved Hispanics. The Northern Manhattan Diabetes Community Outreach Project (NOCHOP) is a two-armed randomised controlled trial to be performed as a community-based participatory research study performed in a Primary Care Setting in Northern Manhattan (New York City). 360 Hispanic adults with poorly controlled type 2 diabetes mellitus (haemoglobin A1c >8%), aged 35-70 years, will be randomised at a 1:1 ratio, within Primary Care Provider clusters. The two study arms are (1) a 12-month CHW intervention and (2) enhanced usual care (educational materials mailed at 4-month intervals, preceded by phone calls). The end points, assessed after 12 months, are primary = haemoglobin A1c and secondary = blood pressure and low-density lipoprotein-cholesterol levels. In addition, the study will describe the CHW intervention in terms of components and intensity and will assess its effects on (1) medication adherence, (2) medication intensification, (3) diet and (4) physical activity. All participants will provide informed consent; the study protocol has been approved by the Institutional Review Board of Columbia University Medical Center. CHW interventions hold great promise in improving the well-being of minority populations who suffer from diabetes mellitus. The NOCHOP study will provide valuable information about the efficacy of those interventions vis-à-vis clinically relevant end points and will inform policy makers through a detailed characterisation of the programme and its effects. NCT00787475 at clinicaltrials.gov.

  3. The serious mental illness health improvement profile [HIP]: study protocol for a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Swift Louise

    2011-07-01

    Full Text Available Abstract Background The serious mental illness Health Improvement Profile [HIP] is a brief pragmatic tool, which enables mental health nurses to work together with patients to screen physical health and take evidence-based action when variables are identified to be at risk. Piloting has demonstrated clinical utility and acceptability. Methods/Design A single blind parallel group cluster randomised controlled trial with secondary economic analysis and process observation. Unit of randomisation: mental health nurses [MHNs] working in adult community mental health teams across two NHS Trusts. Subjects: Patients over 18 years with a diagnosis of schizophrenia, schizoaffective or bipolar disorder on the caseload of participating MHNs. Primary objective: To determine the effects of the HIP programme on patients' physical wellbeing assessed by the physical component score of the Medical Outcome Study (MOS 36 Item Short Form Health Survey version 2 [SF-36v2]. Secondary objectives: To determine the effects of the HIP programme on: cost effectiveness, mental wellbeing, cardiovascular risk, physical health care attitudes and knowledge of MHNs and to determine the acceptability of the HIP Programme in the NHS. Consented nurses (and patients will be randomised to receive the HIP Programme or treatment as usual. Outcomes will be measured at baseline and 12 months with a process observation after 12 months to include evaluation of patients' and professionals' experience and observation of any effect on care plans and primary-secondary care interface communication. Outcomes will be analysed on an intention-to-treat (ITT basis. Discussion The results of the trial and process observation will provide information about the effectiveness of the HIP Programme in supporting MHNs to address physical comorbidity in serious mental illness. Given the current unacceptable prevalence of physical comorbidity and mortality in the serious mental illness population, it is

  4. Analysis of Mechanical Energy Transport on Free-Falling Wedge during Water-Entry Phase

    Directory of Open Access Journals (Sweden)

    Wen-Hua Wang

    2012-01-01

    Full Text Available For better discussing and understanding the physical phenomena and body-fluid interaction of water-entry problem, here mechanical-energy transport (wedge, fluid, and each other of water-entry model for free falling wedge is studied by numerical method based on free surface capturing method and Cartesian cut cell mesh. In this method, incompressible Euler equations for a variable density fluid are numerically calculated by the finite volume method. Then artificial compressibility method, dual-time stepping technique, and Roe's approximate Riemann solver are applied in the numerical scheme. Furthermore, the projection method of momentum equations and exact Riemann solution are used to calculate the fluid pressure on solid boundary. On this basis, during water-entry phase of the free-falling wedge, macroscopic energy conversion of overall body-fluid system and microscopic energy transformation in fluid field are analyzed and discussed. Finally, based on test cases, many useful conclusions about mechanical energy transport for water entry problem are made and presented.

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

    Science.gov (United States)

    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

  6. Laser-based linear and nonlinear guided elastic waves at surfaces (2D) and wedges (1D).

    Science.gov (United States)

    Hess, Peter; Lomonosov, Alexey M; Mayer, Andreas P

    2014-01-01

    The characteristic features and applications of linear and nonlinear guided elastic waves propagating along surfaces (2D) and wedges (1D) are discussed. Laser-based excitation, detection, or contact-free analysis of these guided waves with pump-probe methods are reviewed. Determination of material parameters by broadband surface acoustic waves (SAWs) and other applications in nondestructive evaluation (NDE) are considered. The realization of nonlinear SAWs in the form of solitary waves and as shock waves, used for the determination of the fracture strength, is described. The unique properties of dispersion-free wedge waves (WWs) propagating along homogeneous wedges and of dispersive wedge waves observed in the presence of wedge modifications such as tip truncation or coatings are outlined. Theoretical and experimental results on nonlinear wedge waves in isotropic and anisotropic solids are presented. Copyright © 2013 Elsevier B.V. All rights reserved.

  7. A randomised controlled trial of a web-based educational program in child mental health for schoolteachers.

    Science.gov (United States)

    Pereira, Celina Andrade; Wen, Chao Lung; Miguel, Eurípedes Constantino; Polanczyk, Guilherme V

    2015-08-01

    Children affected by mental disorders are largely unrecognised and untreated across the world. Community resources, including the school system and teachers, are important elements in actions directed to promoting child mental health and preventing and treating mental disorders, especially in low- and middle-income countries. We developed a web-based program to educate primary school teachers on mental disorders in childhood and conducted a cluster-randomised controlled trial to test the effectiveness of the web-based program intervention in comparison with the same program based on text and video materials only and to a waiting-list control group. All nine schools of a single city in the state of São Paulo, Brazil, were randomised to the three groups, and teachers completed the educational programs during 3 weeks. Data were analysed according to complete cases and intention-to-treat approaches. In terms of gains of knowledge about mental disorders, the web-based program intervention was superior to the intervention with text and video materials, and to the waiting-list control group. In terms of beliefs and attitudes about mental disorders, the web-based program intervention group presented less stigmatised concepts than the text and video group and more non-stigmatised concepts than the waiting-list group. No differences were detected in terms of teachers' attitudes. This study demonstrated initial data on the effectiveness of a web-based program in educating schoolteachers on child mental disorders. Future studies are necessary to replicate and extend the findings.

  8. Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hart Michael B

    2010-10-01

    Full Text Available Abstract Background This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Methods and Design Fifty-seven schools (86% of 66 eligible secondary schools in Perth, Australia were recruited to the clustered (by school randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms. Discussion This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide

  9. Radial wedge flange clamp

    Science.gov (United States)

    Smith, Karl H.

    2002-01-01

    A radial wedge flange clamp comprising a pair of flanges each comprising a plurality of peripheral flat wedge facets having flat wedge surfaces and opposed and mating flat surfaces attached to or otherwise engaged with two elements to be joined and including a series of generally U-shaped wedge clamps each having flat wedge interior surfaces and engaging one pair of said peripheral flat wedge facets. Each of said generally U-shaped wedge clamps has in its opposing extremities apertures for the tangential insertion of bolts to apply uniform radial force to said wedge clamps when assembled about said wedge segments.

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

    Science.gov (United States)

    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

  11. Cluster Randomised Trials in Cochrane Reviews: Evaluation of Methodological and Reporting Practice.

    Directory of Open Access Journals (Sweden)

    Marty Richardson

    Full Text Available Systematic reviews can include cluster-randomised controlled trials (C-RCTs, which require different analysis compared with standard individual-randomised controlled trials. However, it is not known whether review authors follow the methodological and reporting guidance when including these trials. The aim of this study was to assess the methodological and reporting practice of Cochrane reviews that included C-RCTs against criteria developed from existing guidance.Criteria were developed, based on methodological literature and personal experience supervising review production and quality. Criteria were grouped into four themes: identifying, reporting, assessing risk of bias, and analysing C-RCTs. The Cochrane Database of Systematic Reviews was searched (2nd December 2013, and the 50 most recent reviews that included C-RCTs were retrieved. Each review was then assessed using the criteria.The 50 reviews we identified were published by 26 Cochrane Review Groups between June 2013 and November 2013. For identifying C-RCTs, only 56% identified that C-RCTs were eligible for inclusion in the review in the eligibility criteria. For reporting C-RCTs, only eight (24% of the 33 reviews reported the method of cluster adjustment for their included C-RCTs. For assessing risk of bias, only one review assessed all five C-RCT-specific risk-of-bias criteria. For analysing C-RCTs, of the 27 reviews that presented unadjusted data, only nine (33% provided a warning that confidence intervals may be artificially narrow. Of the 34 reviews that reported data from unadjusted C-RCTs, only 13 (38% excluded the unadjusted results from the meta-analyses.The methodological and reporting practices in Cochrane reviews incorporating C-RCTs could be greatly improved, particularly with regard to analyses. Criteria developed as part of the current study could be used by review authors or editors to identify errors and improve the quality of published systematic reviews incorporating

  12. Microtopographic control on the ground thermal regime in ice wedge polygons

    Science.gov (United States)

    Abolt, Charles J.; Young, Michael H.; Atchley, Adam L.; Harp, Dylan R.

    2018-06-01

    The goal of this research is to constrain the influence of ice wedge polygon microtopography on near-surface ground temperatures. Ice wedge polygon microtopography is prone to rapid deformation in a changing climate, and cracking in the ice wedge depends on thermal conditions at the top of the permafrost; therefore, feedbacks between microtopography and ground temperature can shed light on the potential for future ice wedge cracking in the Arctic. We first report on a year of sub-daily ground temperature observations at 5 depths and 9 locations throughout a cluster of low-centered polygons near Prudhoe Bay, Alaska, and demonstrate that the rims become the coldest zone of the polygon during winter, due to thinner snowpack. We then calibrate a polygon-scale numerical model of coupled thermal and hydrologic processes against this dataset, achieving an RMSE of less than 1.1 °C between observed and simulated ground temperature. Finally, we conduct a sensitivity analysis of the model by systematically manipulating the height of the rims and the depth of the troughs and tracking the effects on ice wedge temperature. The results indicate that winter temperatures in the ice wedge are sensitive to both rim height and trough depth, but more sensitive to rim height. Rims act as preferential outlets of subsurface heat; increasing rim size decreases winter temperatures in the ice wedge. Deeper troughs lead to increased snow entrapment, promoting insulation of the ice wedge. The potential for ice wedge cracking is therefore reduced if rims are destroyed or if troughs subside, due to warmer conditions in the ice wedge. These findings can help explain the origins of secondary ice wedges in modern and ancient polygons. The findings also imply that the potential for re-establishing rims in modern thermokarst-affected terrain will be limited by reduced cracking activity in the ice wedges, even if regional air temperatures stabilize.

  13. Providing NHS staff with height-adjustable workstations and behaviour change strategies to reduce workplace sitting time: protocol for the Stand More AT (SMArT) Work cluster randomised controlled trial.

    Science.gov (United States)

    O'Connell, S E; Jackson, B R; Edwardson, C L; Yates, T; Biddle, S J H; Davies, M J; Dunstan, D; Esliger, D; Gray, L; Miller, P; Munir, F

    2015-12-09

    High levels of sedentary behaviour (i.e., sitting) are a risk factor for poor health. With high levels of sitting widespread in desk-based office workers, office workplaces are an appropriate setting for interventions aimed at reducing sedentary behaviour. This paper describes the development processes and proposed intervention procedures of Stand More AT (SMArT) Work, a multi-component randomised control (RCT) trial which aims to reduce occupational sitting time in desk-based office workers within the National Health Service (NHS). SMArT Work consists of 2 phases: 1) intervention development: The development of the SMArT Work intervention takes a community-based participatory research approach using the Behaviour Change Wheel. Focus groups will collect detailed information to gain a better understanding of the most appropriate strategies, to sit alongside the provision of height-adjustable workstations, at the environmental, organisational and individual level that support less occupational sitting. 2) intervention delivery and evaluation: The 12 month cluster RCT aims to reduce workplace sitting in the University Hospitals of Leicester NHS Trust. Desk-based office workers (n = 238) will be randomised to control or intervention clusters, with the intervention group receiving height-adjustable workstations and supporting techniques based on the feedback received from the development phase. Data will be collected at four time points; baseline, 3, 6 and 12 months. The primary outcome is a reduction in sitting time, measured by the activPAL(TM) micro at 12 months. Secondary outcomes include objectively measured physical activity and a variety of work-related health and psycho-social measures. A process evaluation will also take place. This study will be the first long-term, evidence-based, multi-component cluster RCT aimed at reducing occupational sitting within the NHS. This study will help form a better understanding and knowledge base of facilitators and

  14. A similarity based agglomerative clustering algorithm in networks

    Science.gov (United States)

    Liu, Zhiyuan; Wang, Xiujuan; Ma, Yinghong

    2018-04-01

    The detection of clusters is benefit for understanding the organizations and functions of networks. Clusters, or communities, are usually groups of nodes densely interconnected but sparsely linked with any other clusters. To identify communities, an efficient and effective community agglomerative algorithm based on node similarity is proposed. The proposed method initially calculates similarities between each pair of nodes, and form pre-partitions according to the principle that each node is in the same community as its most similar neighbor. After that, check each partition whether it satisfies community criterion. For the pre-partitions who do not satisfy, incorporate them with others that having the biggest attraction until there are no changes. To measure the attraction ability of a partition, we propose an attraction index that based on the linked node's importance in networks. Therefore, our proposed method can better exploit the nodes' properties and network's structure. To test the performance of our algorithm, both synthetic and empirical networks ranging in different scales are tested. Simulation results show that the proposed algorithm can obtain superior clustering results compared with six other widely used community detection algorithms.

  15. Efficacy of infant simulator programmes to prevent teenage pregnancy: a school-based cluster randomised controlled trial in Western Australia.

    Science.gov (United States)

    Brinkman, Sally A; Johnson, Sarah E; Codde, James P; Hart, Michael B; Straton, Judith A; Mittinty, Murthy N; Silburn, Sven R

    2016-11-05

    Infant simulator-based programmes, which aim to prevent teenage pregnancy, are used in high-income as well as low-income and middle-income countries but, despite growing popularity, no published evidence exists of their long-term effect. The aim of this trial was to investigate the effect of such a programme, the Virtual Infant Parenting (VIP) programme, on pregnancy outcomes of birth and induced abortion in Australia. In this school-based pragmatic cluster randomised controlled trial, eligible schools in Perth, Western Australia, were enrolled and randomised 1:1 to the intervention and control groups. Randomisation using a table of random numbers without blocking, stratification, or matching was done by a researcher who was masked to the identity of the schools. Between 2003 and 2006, the VIP programme was administered to girls aged 13-15 years in the intervention schools, while girls of the same age in the control schools received the standard health education curriculum. Participants were followed until they reached 20 years of age via data linkage to hospital medical and abortion clinic records. The primary endpoint was the occurrence of pregnancy during the teenage years. Binomial and Cox proportional hazards regression was used to test for differences in pregnancy rates between study groups. This study is registered as an international randomised controlled trial, number ISRCTN24952438. 57 (86%) of 66 eligible schools were enrolled into the trial and randomly assigned 1:1 to the intervention (28 schools) or the control group (29 schools). Then, between Feb 1, 2003, and May 31, 2006, 1267 girls in the intervention schools received the VIP programme while 1567 girls in the control schools received the standard health education curriculum. Compared with girls in the control group, a higher proportion of girls in the intervention group recorded at least one birth (97 [8%] of 1267 in the intervention group vs 67 [4%] of 1567 in the control group) or at least one

  16. Evaluating implementation of a fire-prevention injury prevention briefing in children's centres: Cluster randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Toity Deave

    Full Text Available Many developed countries have high mortality rates for fire-related deaths in children aged 0-14 years with steep social gradients. Evidence-based interventions to promote fire safety practices exist, but the impact of implementing a range of these interventions in children's services has not been assessed. We developed an Injury Prevention Briefing (IPB, which brought together evidence about effective fire safety interventions and good practice in delivering interventions; plus training and facilitation to support its use and evaluated its implementation.We conducted a cluster randomised controlled trial, with integrated qualitative and cost-effectiveness nested studies, across four study sites in England involving children's centres in disadvantaged areas; participants were staff and families attending those centres. Centres were stratified by study site and randomised within strata to one of three arms: IPB plus facilitation (IPB+, IPB only, usual care. IPB+ centres received initial training and facilitation at months 1, 3, and 8. Baseline data from children's centres were collected between August 2011 and January 2012 and follow-up data were collected between June 2012 and June 2013. Parent baseline data were collected between January 2012 and May 2012 and follow-up data between May 2013 and September 2013. Data comprised baseline and 12 month parent- and staff-completed questionnaires, facilitation contact data, activity logs and staff interviews. The primary outcome was whether families had a plan for escaping from a house fire. Treatment arms were compared using multilevel models to account for clustering by children's centre.1112 parents at 36 children's centres participated. There was no significant effect of the intervention on families' possession of plans for escaping from a house fire (adjusted odds ratio (AOR IPB only vs. usual care: 0.93, 95%CI 0.58, 1.49; AOR IPB+ vs. usual care 1.41, 95%CI 0.91, 2.20. However, significantly more

  17. [A Patient with a Wedge-shaped Pulmonary Lesion Associated with Streptococcus parasanguinis].

    Science.gov (United States)

    Miyamoto, Hiroya; Gomi, Harumi; Ishioka, Haruhiko; Shirokawa, Taijiro

    2016-05-01

    An 84-year-old man was admitted to our hospital with bloody sputum. He was found to have a right lower lobe wedge-shaped nodular lesion with chest X-ray and computed tomography of the chest. Ceftriaxone and minocycline were started empirically based on a working diagnosis of community-acquired pneumonia. Streptococcus parasanguinis was isolated with sputum cultures obtained on three consecutive days and was identified based on its biochemical properties. S. parasanguinis is a member of the sanguinis group of viridans Streptococci. It is known as a causative pathogen for endocarditis. There are very few reports of S. parasanguinis associated with pulmonary infections. The present report describes the association of S. parasanguinis with a wedge-shaped nodular lesion in the lungs.

  18. Wedges I

    International Nuclear Information System (INIS)

    DeWitt-Morette, C.; Low, S.G.; Schulman, L.S.; Shiekh, A.Y.

    1986-01-01

    The wedge problem, that is, the propagation of radiation or particles in the presence of a wedge, is examined in different contexts. Generally, the paper follows the historical order from Sommerfeld's early work to recent stochastic results - hindsights and new results being woven in as appropriate. In each context, identifying the relevant mathematical problem has been the key to the solution. Thus each section can be given both a physics and a mathematics title: Section 2: diffraction by reflecting wedge; boundary value problem of differential equations; solutions defined on multiply connected spaces. Section 3: geometrical theory of diffraction; identification of function spaces. Section 4: path integral solutions; path integration on multiply connected spaces; asymptotics on the boundaries of function spaces. Section 5: probing the shape of the wedge and the roughness of its surface; stochastic calculus. Several propagators and Green functions are given explicitly, some old ones and some new ones. They include the knife-edge propagator for Dirichlet and Neumann boundary conditions, the absorbing knife edge propagator, the wedge propagators, the propagator for a free particle on a /sigma phi/-sheeted Riemann surface, the Dirichlet and the Neumann wedge Green function

  19. Cognitive stimulation therapy as a sustainable intervention for dementia in sub-Saharan Africa: feasibility and clinical efficacy using a stepped-wedge design.

    Science.gov (United States)

    Paddick, Stella-Maria; Mkenda, Sarah; Mbowe, Godfrey; Kisoli, Aloyce; Gray, William K; Dotchin, Catherine L; Ternent, Laura; Ogunniyi, Adesola; Kissima, John; Olakehinde, Olaide; Mushi, Declare; Walker, Richard W

    2017-06-01

    Cognitive stimulation therapy (CST) is a psychosocial group-based intervention for dementia shown to improve cognition and quality of life with a similar efficacy to cholinesterase inhibitors. Since CST can be delivered by non-specialist healthcare workers, it has potential for use in low-resource environments, such as sub-Saharan Africa (SSA). We aimed to assess the feasibility and clinical effectiveness of CST in rural Tanzania using a stepped-wedge design. Participants and their carers were recruited through a community dementia screening program. Inclusion criteria were DSM-IV diagnosis of dementia of mild/moderate severity following detailed assessment. No participant had a previous diagnosis of dementia and none were taking a cholinesterase inhibitor. Primary outcomes related to the feasibility of conducting CST in this setting. Key clinical outcomes were changes in quality of life and cognition. The assessing team was blind to treatment group membership. Thirty four participants with mild/moderate dementia were allocated to four CST groups. Attendance rates were high (85%) and we were able to complete all 14 sessions for each group within the seven week timeframe. Substantial improvements in cognition, anxiety, and behavioral symptoms were noted following CST, with smaller improvements in quality of life measures. The number needed to treat was two for a four-point cognitive (adapted Alzheimer's Disease Assessment Scale-Cognitive) improvement. This intervention has the potential to be low-cost, sustainable, and adaptable to other settings across SSA, particularly if it can be delivered by non-specialist health workers.

  20. Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial.

    Science.gov (United States)

    Diop, Ayisha; Daff, Bocar; Sow, Maimouna; Blum, Jennifer; Diagne, Mamadou; Sloan, Nancy L; Winikoff, Beverly

    2016-01-01

    Access to injectable uterotonics for management of postpartum haemorrhage remains limited in Senegal outside health facilities, and misoprostol and oxytocin delivered via Uniject have been deemed viable alternatives in community settings. We aimed to compare the efficacy of these drugs when delivered by auxiliary midwives at maternity huts. We did an unmasked cluster-randomised controlled trial at maternity huts in three districts in Senegal. Maternity huts with auxiliary midwives located 3-21 km from the closest referral centre were randomly assigned (1:1; via a computer-generated random allocation overseen by Gynuity Health Projects) to either 600 μg oral misoprostol or 10 IU oxytocin in Uniject (intramuscular), stratified by reported previous year clinic volume (deliveries) and geographical location (inland or coastal). Maternity huts that had been included in a previous study of misoprostol for prevention of postpartum haemorrhage were excluded to prevent contamination. Pregnant women in their third trimester were screened for eligibility either during community outreach or at home-based prenatal visits. Only women delivered by the auxiliary midwives in the maternity huts were eligible for the study. Women with known allergies to prostaglandins or pregnancy complications were excluded. The primary outcome was mean change in haemoglobin concentration measured during the third trimester and after delivery. This study was registered with ClinicalTrials.gov, number NCT01713153. 28 maternity hut clusters were randomly assigned-14 to the misoprostol group and 14 to the oxytocin group. Between June 6, 2012, and Sept 21, 2013, 1820 women were recruited. 647 women in the misoprostol group and 402 in the oxytocin group received study drug and had recorded pre-delivery and post-delivery haemoglobin concentrations, and overall 1412 women delivered in the study maternity huts. The mean change in haemoglobin concentrations was 3·5 g/L (SD 16·1) in the misoprostol group

  1. Weighted community detection and data clustering using message passing

    Science.gov (United States)

    Shi, Cheng; Liu, Yanchen; Zhang, Pan

    2018-03-01

    Grouping objects into clusters based on the similarities or weights between them is one of the most important problems in science and engineering. In this work, by extending message-passing algorithms and spectral algorithms proposed for an unweighted community detection problem, we develop a non-parametric method based on statistical physics, by mapping the problem to the Potts model at the critical temperature of spin-glass transition and applying belief propagation to solve the marginals corresponding to the Boltzmann distribution. Our algorithm is robust to over-fitting and gives a principled way to determine whether there are significant clusters in the data and how many clusters there are. We apply our method to different clustering tasks. In the community detection problem in weighted and directed networks, we show that our algorithm significantly outperforms existing algorithms. In the clustering problem, where the data were generated by mixture models in the sparse regime, we show that our method works all the way down to the theoretical limit of detectability and gives accuracy very close to that of the optimal Bayesian inference. In the semi-supervised clustering problem, our method only needs several labels to work perfectly in classic datasets. Finally, we further develop Thouless-Anderson-Palmer equations which heavily reduce the computation complexity in dense networks but give almost the same performance as belief propagation.

  2. A possible mechanism for earthquakes found in the mantle wedge of the Nazca subduction zone

    Science.gov (United States)

    Warren, L. M.; Chang, Y.; Prieto, G. A.

    2017-12-01

    Beneath Colombia, the Cauca cluster of intermediate-depth earthquakes extends for 200 km along the trench (3.5°N-5.5°N, 77.0°W-75.3°W) and, with 58 earthquakes per year with local magnitude ML >= 2.5, has a higher rate of seismicity than the subduction zone immediately to the north or south. By precisely locating 433 cluster earthquakes from 1/2010-3/2014 with data from the Colombian National Seismic Network, we found that the earthquakes are located both in a continuous Nazca plate subducting at an angle of 33°-43° and in the overlying mantle wedge. The mantle wedge earthquakes (12% of the earthquakes) form two isolated 40-km-tall columns extending perpendicular to the subducting slab. Using waveform inversion, we computed focal mechanisms for 69 of the larger earthquakes. The focal mechanisms are variable, but the intraslab earthquakes are generally consistent with an in-slab extensional stress axis oriented 25° counterclockwise from the down-dip direction. We suggest that the observed mantle wedge earthquakes are the result of hydrofracture in a relatively cool mantle wedge. This segment of the Nazca Plate is currently subducting at a normal angle, but Wagner et al. (2017) suggested that a flat slab slowly developed in the region between 9-5.9 Ma and persisted until 4 Ma. During flat slab subduction, the overlying mantle wedge typically cools because it is cut off from mantle corner flow. After hydrous minerals in the slab dehydrate, the dehydrated fluid is expelled from the slab and migrates through the mantle wedge. If a cool mantle wedge remains today, fluid dehydrated from the slab may generate earthquakes by hydrofracture, with the mantle wedge earthquakes representing fluid migration pathways. Dahm's (2000) model of water-filled fracture propagation in the mantle wedge shows hydrofractures propagating normal to the subducting slab and extending tens of km into the mantle wedge, as we observe.

  3. A perturbation-based balance training program for older adults: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Peters Amy L

    2007-05-01

    Full Text Available Abstract Background Previous research investigating exercise as a means of falls prevention in older adults has shown mixed results. Lack of specificity of the intervention may be an important factor contributing to negative results. Change-in-support (CIS balance reactions, which involve very rapid stepping or grasping movements of the limbs, play a critical role in preventing falls; hence, a training program that improves ability to execute effective CIS reactions could potentially have a profound effect in reducing risk of falling. This paper describes: 1 the development of a perturbation-based balance training program that targets specific previously-reported age-related impairments in CIS reactions, and 2 a study protocol to evaluate the efficacy of this new training program. Methods/Design The training program involves use of unpredictable, multi-directional moving-platform perturbations to evoke stepping and grasping reactions. Perturbation magnitude is gradually increased over the course of the 6-week program, and concurrent cognitive and movement tasks are included during later sessions. The program was developed in accordance with well-established principles of motor learning, such as individualisation, specificity, overload, adaptation-progression and variability. Specific goals are to reduce the frequency of multiple-step responses, reduce the frequency of collisions between the stepping foot and stance leg, and increase the speed of grasping reactions. A randomised control trial will be performed to evaluate the efficacy of the training program. A total of 30 community-dwelling older adults (age 64–80 with a recent history of instability or falling will be assigned to either the perturbation-based training or a control group (flexibility/relaxation training, using a stratified randomisation that controls for gender, age and baseline stepping/grasping performance. CIS reactions will be tested immediately before and after the six

  4. 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

  5. Numerical Study on Critical Wedge Angle of Cellular Detonation Reflections

    International Nuclear Information System (INIS)

    Gang, Wang; Kai-Xin, Liu; De-Liang, Zhang

    2010-01-01

    The critical wedge angle (CWA) for the transition from regular reflection (RR) to Mach reflection (MR) of a cellular detonation wave is studied numerically by an improved space-time conservation element and solution element method together with a two-step chemical reaction model. The accuracy of that numerical way is verified by simulating cellular detonation reflections at a 19.3° wedge. The planar and cellular detonation reflections over 45°–55° wedges are also simulated. When the cellular detonation wave is over a 50° wedge, numerical results show a new phenomenon that RR and MR occur alternately. The transition process between RR and MR is investigated with the local pressure contours. Numerical analysis shows that the cellular structure is the essential reason for the new phenomenon and the CWA of detonation reflection is not a certain angle but an angle range. (fundamental areas of phenomenology(including applications))

  6. A comparison of confidence interval methods for the intraclass correlation coefficient in community-based cluster randomization trials with a binary outcome.

    Science.gov (United States)

    Braschel, Melissa C; Svec, Ivana; Darlington, Gerarda A; Donner, Allan

    2016-04-01

    Many investigators rely on previously published point estimates of the intraclass correlation coefficient rather than on their associated confidence intervals to determine the required size of a newly planned cluster randomized trial. Although confidence interval methods for the intraclass correlation coefficient that can be applied to community-based trials have been developed for a continuous outcome variable, fewer methods exist for a binary outcome variable. The aim of this study is to evaluate confidence interval methods for the intraclass correlation coefficient applied to binary outcomes in community intervention trials enrolling a small number of large clusters. Existing methods for confidence interval construction are examined and compared to a new ad hoc approach based on dividing clusters into a large number of smaller sub-clusters and subsequently applying existing methods to the resulting data. Monte Carlo simulation is used to assess the width and coverage of confidence intervals for the intraclass correlation coefficient based on Smith's large sample approximation of the standard error of the one-way analysis of variance estimator, an inverted modified Wald test for the Fleiss-Cuzick estimator, and intervals constructed using a bootstrap-t applied to a variance-stabilizing transformation of the intraclass correlation coefficient estimate. In addition, a new approach is applied in which clusters are randomly divided into a large number of smaller sub-clusters with the same methods applied to these data (with the exception of the bootstrap-t interval, which assumes large cluster sizes). These methods are also applied to a cluster randomized trial on adolescent tobacco use for illustration. When applied to a binary outcome variable in a small number of large clusters, existing confidence interval methods for the intraclass correlation coefficient provide poor coverage. However, confidence intervals constructed using the new approach combined with Smith

  7. The effectiveness and cost-effectiveness of opportunistic screening and stepped care interventions for older hazardous alcohol users in primary care (AESOPS – A randomised control trial protocol

    Directory of Open Access Journals (Sweden)

    Morton Veronica

    2008-06-01

    Full Text Available Abstract Background There is a wealth of evidence regarding the detrimental impact of excessive alcohol consumption. In older populations excessive alcohol consumption is associated with increased risk of coronary heart disease, hypertension, stroke and a range of cancers. Alcohol consumption is also associated with an increased risk of falls, early onset of dementia and other cognitive deficits. Physiological changes that occur as part of the ageing process mean that older people experience alcohol related problems at lower consumption levels. There is a strong evidence base for the effectiveness of brief psychosocial interventions in reducing alcohol consumption in populations identified opportunistically in primary care settings. Stepped care interventions involve the delivery of more intensive interventions only to those in the population who fail to respond to less intensive interventions and provide a potentially resource efficient means of meeting the needs of this population. Methods/design The study design is a pragmatic prospective multi-centre two arm randomised controlled trial. The primary hypothesis is that stepped care interventions for older hazardous alcohol users reduce alcohol consumption compared with a minimal intervention at 12 months post randomisation. Potential participants are identified using the AUDIT questionnaire. Eligible and consenting participants are randomised with equal probability to either a minimal intervention or a three step treatment approach. The step treatment approach incorporates as step 1 behavioural change counselling, step 2 three sessions of motivational enhancement therapy and step 3 referral to specialist services. The primary outcome is measured using average standard drinks per day and secondary outcome measures include the Drinking Problems Index, health related quality of life and health utility. The study incorporates a comprehensive economic analysis to assess the relative cost

  8. Projection-based curve clustering

    International Nuclear Information System (INIS)

    Auder, Benjamin; Fischer, Aurelie

    2012-01-01

    This paper focuses on unsupervised curve classification in the context of nuclear industry. At the Commissariat a l'Energie Atomique (CEA), Cadarache (France), the thermal-hydraulic computer code CATHARE is used to study the reliability of reactor vessels. The code inputs are physical parameters and the outputs are time evolution curves of a few other physical quantities. As the CATHARE code is quite complex and CPU time-consuming, it has to be approximated by a regression model. This regression process involves a clustering step. In the present paper, the CATHARE output curves are clustered using a k-means scheme, with a projection onto a lower dimensional space. We study the properties of the empirically optimal cluster centres found by the clustering method based on projections, compared with the 'true' ones. The choice of the projection basis is discussed, and an algorithm is implemented to select the best projection basis among a library of orthonormal bases. The approach is illustrated on a simulated example and then applied to the industrial problem. (authors)

  9. Improved field abutment-wedge design for 6-MV x-rays

    International Nuclear Information System (INIS)

    Nyerick, C.E.; Steadham, R.E.

    1989-01-01

    This paper presents an improved abutment wedge for matching large photon fields. The wedge is used with a 6-MV Linac accelerator and generates a 5-cm pseudopenumbra at the 50% relative dose juncture. The features allow treatment of fields up to 40 cm long in any fractional step of increment, simultaneous generation of two wide penumbrae or one wide and one sharp penumbra, and attachment of the device downstream of standard beam-shaping accessories in any 90 degrees angular orientation

  10. Studying wedge factors and beam profiles for physical and enhanced dynamic wedges

    Directory of Open Access Journals (Sweden)

    Ahmad Misbah

    2010-01-01

    Full Text Available This study was designed to investigate variation in Varian′s Physical and Enhanced Dynamic Wedge Factors (WF as a function of depth and field size. The profiles for physical wedges (PWs and enhanced dynamic wedges (EDWs were also measured using LDA-99 array and compared for confirmation of EDW angles at different depths and field sizes. WF measurements were performed in water phantom using cylindrical 0.66 cc ionization chamber. WF was measured by taking the ratio of wedge and open field ionization data. A normalized wedge factor (NWF was introduced to circumvent large differences between wedge factors for different wedge angles. A strong linear dependence of PW Factor (PWF with depth was observed. Maximum variation of 8.9% and 4.1% was observed for 60° PW with depth at 6 and 15 MV beams respectively. The variation in EDW Factor (EDWF with depth was almost negligible and less than two per cent. The highest variation in PWF as a function of field size was 4.1% and 3.4% for thicker wedge (60° at 6 and 15 MV beams respectively and decreases with decreasing wedge angle. EDWF shows strong field size dependence and significant variation was observed for all wedges at both photon energies. Differences in profiles between PW and EDW were observed on toe and heel sides. These differences were dominant for larger fields, shallow depths, thicker wedges and low energy beam. The study indicated that ignoring depth and field size dependence of WF may result in under/over dose to the patient especially doing manual point dose calculation.

  11. TRUSTWORTHY OPTIMIZED CLUSTERING BASED TARGET DETECTION AND TRACKING FOR WIRELESS SENSOR NETWORK

    Directory of Open Access Journals (Sweden)

    C. Jehan

    2016-06-01

    Full Text Available In this paper, an efficient approach is proposed to address the problem of target tracking in wireless sensor network (WSN. The problem being tackled here uses adaptive dynamic clustering scheme for tracking the target. It is a specific problem in object tracking. The proposed adaptive dynamic clustering target tracking scheme uses three steps for target tracking. The first step deals with the identification of clusters and cluster heads using OGSAFCM. Here, kernel fuzzy c-means (KFCM and gravitational search algorithm (GSA are combined to create clusters. At first, oppositional gravitational search algorithm (OGSA is used to optimize the initial clustering center and then the KFCM algorithm is availed to guide the classification and the cluster formation process. In the OGSA, the concept of the opposition based population initialization in the basic GSA to improve the convergence profile. The identified clusters are changed dynamically. The second step deals with the data transmission to the cluster heads. The third step deals with the transmission of aggregated data to the base station as well as the detection of target. From the experimental results, the proposed scheme efficiently and efficiently identifies the target. As a result the tracking error is minimized.

  12. Reducing child conduct problems and promoting social skills in a middle-income country: cluster randomised controlled trial.

    Science.gov (United States)

    Baker-Henningham, Helen; Scott, Stephen; Jones, Kelvyn; Walker, Susan

    2012-08-01

    There is an urgent need for effective, affordable interventions to prevent child mental health problems in low- and middle-income countries. To determine the effects of a universal pre-school-based intervention on child conduct problems and social skills at school and at home. In a cluster randomised design, 24 community pre-schools in inner-city areas of Kingston, Jamaica, were randomly assigned to receive the Incredible Years Teacher Training intervention (n = 12) or to a control group (n = 12). Three children from each class with the highest levels of teacher-reported conduct problems were selected for evaluation, giving 225 children aged 3-6 years. The primary outcome was observed child behaviour at school. Secondary outcomes were child behaviour by parent and teacher report, child attendance and parents' attitude to school. The study is registered as ISRCTN35476268. Children in intervention schools showed significantly reduced conduct problems (effect size (ES) = 0.42) and increased friendship skills (ES = 0.74) through observation, significant reductions to teacher-reported (ES = 0.47) and parent-reported (ES = 0.22) behaviour difficulties and increases in teacher-reported social skills (ES = 0.59) and child attendance (ES = 0.30). Benefits to parents' attitude to school were not significant. A low-cost, school-based intervention in a middle-income country substantially reduces child conduct problems and increases child social skills at home and at school.

  13. Information and Choice of A-Level Subjects: A Cluster Randomised Controlled Trial with Linked Administrative Data

    Science.gov (United States)

    Davies, Peter; Davies, Neil M.; Qiu, Tian

    2017-01-01

    We estimated the effects of an intervention which provided information about graduate wages to 5593 students in England, using a blinded cluster randomised controlled trial in 50 schools (registration: AEARCTR-0000468). Our primary outcome was students' choice of A-level subjects at age 16. We also recorded the students' expectations of future…

  14. Uptake of community-based, self-collected HPV testing vs. visual inspection with acetic acid for cervical cancer screening in Kampala, Uganda: preliminary results of a randomised controlled trial.

    Science.gov (United States)

    Moses, Erin; Pedersen, Heather N; Mitchell, Sheona M; Sekikubo, Musa; Mwesigwa, David; Singer, Joel; Biryabarema, Christine; Byamugisha, Josaphat K; Money, Deborah M; Ogilvie, Gina S

    2015-10-01

    To compare two cervical cancer screening methods: community-based self-collection of high-risk human papillomavirus (HR-HPV) testing and visual inspection with acetic acid (VIA). Pilot randomised controlled trial of 500 women aged 30-65 in the community of Kisenyi, Uganda. Women randomised to self-collection-based HR-HPV testing provided a cervico-vaginal swab for HR-HPV, and results were provided by phone after laboratory testing. Women who tested HPV positive were referred for VIA at the local health unit. Women randomised to VIA underwent screening at the local health unit, where women who tested positive with VIA were provided cryotherapy at time of screening, as per local standard of care. Women were referred for colposcopy when indicated. Outcome measures were uptake of screening, HR-HPV prevalence, VIA result and treatment rates. In the HR-HPV arm, 248 of 250 (p < 0.01) women provided samples, while in the VIA arm, 121 of 250 (48.4%) women attended screening. Among the 73 of 248 HR-HPV-positive women, 45.2% (N = 33) attended VIA screening for follow-up, 21.2% (N = 7) of whom screened positive; five received treatment and two were missing clinical follow-up records. Of the 121 women in the VIA arm who attended screening, 13.2% (N = 16) screened positive; seven received cryotherapy, three refused treatment, five were referred to colposcopy; and one woman had suspected cervical cancer and received treatment after confirmatory testing. This pilot study demonstrated trial feasibility and willingness of the women to participate and be randomised successfully into the two arms. Self-collection-based cervical cancer screening had a higher uptake than VIA. © 2015 John Wiley & Sons Ltd.

  15. Effects of Lateral Heel Wedges and Lateral Forefoot Wedge on the Knee Adduction Moment in Healthy Male Students

    Directory of Open Access Journals (Sweden)

    Fatemeh Shamsi

    2012-01-01

    Full Text Available Objective: Lateral wedged insoles have been designed to decrease the force applied on the medial knee compartment. The aim of this study was to assess the effects of laterally wedged insoles regarding to the placement of the wedge under the sole (under the heel or under the forefoot on the knee adduction moment and the ground reaction forces. Material & Methods: In this pretest-posttest study, three-dimensional gait analysis was performed on 20 healthy men between 18-30 years old. Knee adduction moment and ground reaction forces were compared among following three types of insoles: a flat insole, a 6˚ laterally inclined heel wedged insole and a 6˚ laterally- inclined forefoot wedged insole. Results: there was no difference between three conditions (flat insole (9.72±1.501, lateral heel wedge (9.866±2.141 and lateral forefoot wedge (9.952±1.986 in peak knee adduction moment (P>0.05. Ground reaction forces and spatiotemporal parameters of gait were not affected by any types of these insoles (P>0.05. Conclusion: Based on the current finding, placement of the lateral wedge under the sole, that is, under the heel or under the forefoot has no effect on the efficacy of these insoles on the adduction moment of the knee and ground reaction forces.

  16. 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.

  17. Kinematic segmentation of accretive wedges based on scaled sandbox experiments and their application to nature

    Science.gov (United States)

    Lohrmann, J.; Kukowski, N.; Oncken, O.

    2003-04-01

    Recording the incremental displacement field of scaled analogue simulations provides detailed data on wedge kinematics and timing of internal deformation. This is a very efficient tool to develop kinematic concepts and test mechanical theories, e.g. the critical-taper theory. Such models could not be validated until now by the available geological and geophysical data, since there was no information about the incremental displacement field. Recent GPS measurements and seismological investigations at convergent margins provide well-constrained strain-rates and kinematics of short-termed processes. These data allow the kinematic models that are based on analogue simulations to be tested against field observations. We investigate convergent accretive sand wedges in scaled analogue simulations. We define three kinematic segments based on distinctive wedge taper, displacement field and timing of deformation (recorded at a slow sampling rate, which represents the geological scale). Only one of these segments is in a critical state of stress, whereas the other segments are either in a sub-critical or stable state of stress. Such a kinematic segmentation is not predicted for ideally homogeneous wedge-shaped bodies by the critical-taper theory, but can be explained by the formation of localised weak shear zones, which preferentially accommodate deformation. These weak zones are formed in granular analogue materials, and also in natural rocks, since these materials show a strain-softening phase prior to the achievement of stable mechanical conditions. Therefore we suggest that the kinematic segmentation of convergent sand wedges should also be observed in natural settings, such as accretionary wedges, foreland fold-and-thrust belts and even entire orogens. To validate this hypothesis we compare strain rates from GPS measurements and kinematics deduced from focal mechanisms with the respective data from sandbox experiments. We present a strategy to compare strain rates and

  18. Uptake of Home-Based HIV Testing, Linkage to Care, and Community Attitudes about ART in Rural KwaZulu-Natal, South Africa: Descriptive Results from the First Phase of the ANRS 12249 TasP Cluster-Randomised Trial.

    Directory of Open Access Journals (Sweden)

    Collins C Iwuji

    2016-08-01

    Full Text Available The 2015 WHO recommendation of antiretroviral therapy (ART for all immediately following HIV diagnosis is partially based on the anticipated impact on HIV incidence in the surrounding population. We investigated this approach in a cluster-randomised trial in a high HIV prevalence setting in rural KwaZulu-Natal. We present findings from the first phase of the trial and report on uptake of home-based HIV testing, linkage to care, uptake of ART, and community attitudes about ART.Between 9 March 2012 and 22 May 2014, five clusters in the intervention arm (immediate ART offered to all HIV-positive adults and five clusters in the control arm (ART offered according to national guidelines, i.e., CD4 count ≤ 350 cells/μl contributed to the first phase of the trial. Households were visited every 6 mo. Following informed consent and administration of a study questionnaire, each resident adult (≥16 y was asked for a finger-prick blood sample, which was used to estimate HIV prevalence, and offered a rapid HIV test using a serial HIV testing algorithm. All HIV-positive adults were referred to the trial clinic in their cluster. Those not linked to care 3 mo after identification were contacted by a linkage-to-care team. Study procedures were not blinded. In all, 12,894 adults were registered as eligible for participation (5,790 in intervention arm; 7,104 in control arm, of whom 9,927 (77.0% were contacted at least once during household visits. HIV status was ever ascertained for a total of 8,233/9,927 (82.9%, including 2,569 ascertained as HIV-positive (942 tested HIV-positive and 1,627 reported a known HIV-positive status. Of the 1,177 HIV-positive individuals not previously in care and followed for at least 6 mo in the trial, 559 (47.5% visited their cluster trial clinic within 6 mo. In the intervention arm, 89% (194/218 initiated ART within 3 mo of their first clinic visit. In the control arm, 42.3% (83/196 had a CD4 count ≤ 350 cells/μl at first

  19. The Effects of Skill Training on Social Workers' Professional Competences in Norway: Results of a Cluster-Randomised Study

    Science.gov (United States)

    Malmberg-Heimonen, Ira; Natland, Sidsel; Tøge, Anne Grete; Hansen, Helle Cathrine

    2016-01-01

    Using a cluster-randomised design, this study analyses the effects of a government-administered skill training programme for social workers in Norway. The training programme aims to improve social workers' professional competences by enhancing and systematising follow-up work directed towards longer-term unemployed clients in the following areas: encountering the user, system-oriented efforts and administrative work. The main tools and techniques of the programme are based on motivational interviewing and appreciative inquiry. The data comprise responses to baseline and eighteen-month follow-up questionnaires administered to all social workers (n = 99) in eighteen participating Labour and Welfare offices randomised into experimental and control groups. The findings indicate that the skill training programme positively affected the social workers' evaluations of their professional competences and quality of work supervision received. The acquisition and mastering of combinations of specific tools and techniques, a comprehensive supervision structure and the opportunity to adapt the learned skills to local conditions were important in explaining the results. PMID:27559232

  20. Preventing Australian football injuries with a targeted neuromuscular control exercise programme: comparative injury rates from a training intervention delivered in a clustered randomised controlled trial.

    Science.gov (United States)

    Finch, Caroline F; Twomey, Dara M; Fortington, Lauren V; Doyle, Tim L A; Elliott, Bruce C; Akram, Muhammad; Lloyd, David G

    2016-04-01

    Exercise-based training programmes are commonly used to prevent sports injuries but programme effectiveness within community men's team sport is largely unknown. To present the intention-to-treat analysis of injury outcomes from a clustered randomised controlled trial in community Australian football. Players from 18 male, non-elite, community Australian football clubs across two states were randomly allocated to either a neuromuscular control (NMC) (intervention n=679 players) or standard-practice (control n=885 players) exercise training programme delivered as part of regular team training sessions (2× weekly for 8-week preseason and 18-week regular-season). All game-related injuries and hours of game participation were recorded. Generalised estimating equations, adjusted for clustering (club unit), were used to compute injury incidence rates (IIRs) for all injuries, lower limb injuries (LLIs) and knee injuries sustained during games. The IIRs were compared across groups with cluster-adjusted Injury Rate Ratios (IRRs). Overall, 773 game injuries were recorded. The lower limb was the most frequent body region injured, accounting for 50% of injuries overall, 96 (12%) of which were knee injuries. The NMC players had a reduced LLI rate compared with control players (IRR: 0.78 (95% CI 0.56 to 1.08), p=0.14.) The knee IIR was also reduced for NMC compared with control players (IRR: 0.50 (95% CI 0.24 to 1.05), p=0.07). These intention-to-treat results indicate that positive outcomes can be achieved from targeted training programmes for reducing knee and LLI injury rates in men's community sport. While not statistically significant, reducing the knee injury rate by 50% and the LLI rate by 22% is still a clinically important outcome. Further injury reductions could be achieved with improved training attendance and participation in the programme. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to

  1. Clusters of community exposure to coastal flooding hazards based on storm and sea level rise scenarios—implications for adaptation networks in the San Francisco Bay region

    Science.gov (United States)

    Hummel, Michelle; Wood, Nathan J.; Schweikert, Amy; Stacey, Mark T.; Jones, Jeanne; Barnard, Patrick L.; Erikson, Li H.

    2018-01-01

    Sea level is projected to rise over the coming decades, further increasing the extent of flooding hazards in coastal communities. Efforts to address potential impacts from climate-driven coastal hazards have called for collaboration among communities to strengthen the application of best practices. However, communities currently lack practical tools for identifying potential partner communities based on similar hazard exposure characteristics. This study uses statistical cluster analysis to identify similarities in community exposure to flooding hazards for a suite of sea level rise and storm scenarios. We demonstrate this approach using 63 jurisdictions in the San Francisco Bay region of California (USA) and compare 21 distinct exposure variables related to residents, employees, and structures for six hazard scenario combinations of sea level rise and storms. Results indicate that cluster analysis can provide an effective mechanism for identifying community groupings. Cluster compositions changed based on the selected societal variables and sea level rise scenarios, suggesting that a community could participate in multiple networks to target specific issues or policy interventions. The proposed clustering approach can serve as a data-driven foundation to help communities identify other communities with similar adaptation challenges and to enhance regional efforts that aim to facilitate adaptation planning and investment prioritization.

  2. Intensity-Modulated Radiotherapy Results in Significant Decrease in Clinical Toxicities Compared With Conventional Wedge-Based Breast Radiotherapy

    International Nuclear Information System (INIS)

    Harsolia, Asif; Kestin, Larry; Grills, Inga; Wallace, Michelle; Jolly, Shruti; Jones, Cortney; Lala, Moinaktar; Martinez, Alvaro; Schell, Scott; Vicini, Frank A.

    2007-01-01

    Purpose: We have previously demonstrated that intensity-modulated radiotherapy (IMRT) with a static multileaf collimator process results in a more homogenous dose distribution compared with conventional wedge-based whole breast irradiation (WBI). In the present analysis, we reviewed the acute and chronic toxicity of this IMRT approach compared with conventional wedge-based treatment. Methods and Materials: A total of 172 patients with Stage 0-IIB breast cancer were treated with lumpectomy followed by WBI. All patients underwent treatment planning computed tomography and received WBI (median dose, 45 Gy) followed by a boost to 61 Gy. Of the 172 patients, 93 (54%) were treated with IMRT, and the 79 patients (46%) treated with wedge-based RT in a consecutive fashion immediately before this cohort served as the control group. The median follow-up was 4.7 years. Results: A significant reduction in acute Grade 2 or worse dermatitis, edema, and hyperpigmentation was seen with IMRT compared with wedges. A trend was found toward reduced acute Grade 3 or greater dermatitis (6% vs. 1%, p = 0.09) in favor of IMRT. Chronic Grade 2 or worse breast edema was significantly reduced with IMRT compared with conventional wedges. No difference was found in cosmesis scores between the two groups. In patients with larger breasts (≥1,600 cm 3 , n = 64), IMRT resulted in reduced acute (Grade 2 or greater) breast edema (0% vs. 36%, p <0.001) and hyperpigmentation (3% vs. 41%, p 0.001) and chronic (Grade 2 or greater) long-term edema (3% vs. 30%, p 0.007). Conclusion: The use of IMRT in the treatment of the whole breast results in a significant decrease in acute dermatitis, edema, and hyperpigmentation and a reduction in the development of chronic breast edema compared with conventional wedge-based RT

  3. Text messaging reminders for influenza vaccine in primary care: protocol for a cluster randomised controlled trial (TXT4FLUJAB).

    Science.gov (United States)

    Herrett, Emily; van Staa, Tjeerd; Free, Caroline; Smeeth, Liam

    2014-05-02

    The UK government recommends that at least 75% of people aged under 64 with certain conditions receive an annual influenza vaccination. Primary care practices often fall short of this target and strategies to increase vaccine uptake are required. Text messaging reminders are already used in 30% of practices to remind patients about vaccination, but there has been no trial addressing their effectiveness in increasing influenza vaccine uptake in the UK. The aims of the study are (1) to develop the methodology for conducting cluster randomised trials of text messaging interventions utilising routine electronic health records and (2) to assess the effectiveness of using a text messaging influenza vaccine reminder in achieving an increase in influenza vaccine uptake in patients aged 18-64 with chronic conditions, compared with standard care. This cluster randomised trial will recruit general practices across three settings in English primary care (Clinical Practice Research Datalink, ResearchOne and London iPLATO text messaging software users) and randomise them to either standard care or a text messaging campaign to eligible patients. Flu vaccine uptake will be ascertained using routinely collected, anonymised electronic patient records. This protocol outlines the proposed study design and analysis methods. This study will determine the effectiveness of text messaging vaccine reminders in primary care in increasing influenza vaccine uptake, and will strengthen the methodology for using electronic health records in cluster randomised trials of text messaging interventions. This trial was approved by the Surrey Borders Ethics Committee (13/LO/0872). The trial results will be disseminated at national conferences and published in a peer-reviewed medical journal. The results will also be distributed to the Primary Care Research Network and to all participating general practices. This study is registered at controlled-trials.com ISRCTN48840025, July 2013.

  4. Sample size calculations for cluster randomised crossover trials in Australian and New Zealand intensive care research.

    Science.gov (United States)

    Arnup, Sarah J; McKenzie, Joanne E; Pilcher, David; Bellomo, Rinaldo; Forbes, Andrew B

    2018-06-01

    The cluster randomised crossover (CRXO) design provides an opportunity to conduct randomised controlled trials to evaluate low risk interventions in the intensive care setting. Our aim is to provide a tutorial on how to perform a sample size calculation for a CRXO trial, focusing on the meaning of the elements required for the calculations, with application to intensive care trials. We use all-cause in-hospital mortality from the Australian and New Zealand Intensive Care Society Adult Patient Database clinical registry to illustrate the sample size calculations. We show sample size calculations for a two-intervention, two 12-month period, cross-sectional CRXO trial. We provide the formulae, and examples of their use, to determine the number of intensive care units required to detect a risk ratio (RR) with a designated level of power between two interventions for trials in which the elements required for sample size calculations remain constant across all ICUs (unstratified design); and in which there are distinct groups (strata) of ICUs that differ importantly in the elements required for sample size calculations (stratified design). The CRXO design markedly reduces the sample size requirement compared with the parallel-group, cluster randomised design for the example cases. The stratified design further reduces the sample size requirement compared with the unstratified design. The CRXO design enables the evaluation of routinely used interventions that can bring about small, but important, improvements in patient care in the intensive care setting.

  5. CORECLUSTER: A Degeneracy Based Graph Clustering Framework

    OpenAIRE

    Giatsidis , Christos; Malliaros , Fragkiskos; Thilikos , Dimitrios M. ,; Vazirgiannis , Michalis

    2014-01-01

    International audience; Graph clustering or community detection constitutes an important task forinvestigating the internal structure of graphs, with a plethora of applications in several domains. Traditional tools for graph clustering, such asspectral methods, typically suffer from high time and space complexity. In thisarticle, we present \\textsc{CoreCluster}, an efficient graph clusteringframework based on the concept of graph degeneracy, that can be used along withany known graph clusteri...

  6. Semi-supervised spectral algorithms for community detection in complex networks based on equivalence of clustering methods

    Science.gov (United States)

    Ma, Xiaoke; Wang, Bingbo; Yu, Liang

    2018-01-01

    Community detection is fundamental for revealing the structure-functionality relationship in complex networks, which involves two issues-the quantitative function for community as well as algorithms to discover communities. Despite significant research on either of them, few attempt has been made to establish the connection between the two issues. To attack this problem, a generalized quantification function is proposed for community in weighted networks, which provides a framework that unifies several well-known measures. Then, we prove that the trace optimization of the proposed measure is equivalent with the objective functions of algorithms such as nonnegative matrix factorization, kernel K-means as well as spectral clustering. It serves as the theoretical foundation for designing algorithms for community detection. On the second issue, a semi-supervised spectral clustering algorithm is developed by exploring the equivalence relation via combining the nonnegative matrix factorization and spectral clustering. Different from the traditional semi-supervised algorithms, the partial supervision is integrated into the objective of the spectral algorithm. Finally, through extensive experiments on both artificial and real world networks, we demonstrate that the proposed method improves the accuracy of the traditional spectral algorithms in community detection.

  7. Identifying typical patterns of vulnerability: A 5-step approach based on cluster analysis

    Science.gov (United States)

    Sietz, Diana; Lüdeke, Matthias; Kok, Marcel; Lucas, Paul; Carsten, Walther; Janssen, Peter

    2013-04-01

    Specific processes that shape the vulnerability of socio-ecological systems to climate, market and other stresses derive from diverse background conditions. Within the multitude of vulnerability-creating mechanisms, distinct processes recur in various regions inspiring research on typical patterns of vulnerability. The vulnerability patterns display typical combinations of the natural and socio-economic properties that shape a systems' vulnerability to particular stresses. Based on the identification of a limited number of vulnerability patterns, pattern analysis provides an efficient approach to improving our understanding of vulnerability and decision-making for vulnerability reduction. However, current pattern analyses often miss explicit descriptions of their methods and pay insufficient attention to the validity of their groupings. Therefore, the question arises as to how do we identify typical vulnerability patterns in order to enhance our understanding of a systems' vulnerability to stresses? A cluster-based pattern recognition applied at global and local levels is scrutinised with a focus on an applicable methodology and practicable insights. Taking the example of drylands, this presentation demonstrates the conditions necessary to identify typical vulnerability patterns. They are summarised in five methodological steps comprising the elicitation of relevant cause-effect hypotheses and the quantitative indication of mechanisms as well as an evaluation of robustness, a validation and a ranking of the identified patterns. Reflecting scale-dependent opportunities, a global study is able to support decision-making with insights into the up-scaling of interventions when available funds are limited. In contrast, local investigations encourage an outcome-based validation. This constitutes a crucial step in establishing the credibility of the patterns and hence their suitability for informing extension services and individual decisions. In this respect, working at

  8. School-based suicide prevention programmes: the SEYLE cluster-randomised, controlled trial.

    Science.gov (United States)

    Wasserman, Danuta; Hoven, Christina W; Wasserman, Camilla; Wall, Melanie; Eisenberg, Ruth; Hadlaczky, Gergö; Kelleher, Ian; Sarchiapone, Marco; Apter, Alan; Balazs, Judit; Bobes, Julio; Brunner, Romuald; Corcoran, Paul; Cosman, Doina; Guillemin, Francis; Haring, Christian; Iosue, Miriam; Kaess, Michael; Kahn, Jean-Pierre; Keeley, Helen; Musa, George J; Nemes, Bogdan; Postuvan, Vita; Saiz, Pilar; Reiter-Theil, Stella; Varnik, Airi; Varnik, Peeter; Carli, Vladimir

    2015-04-18

    Suicidal behaviours in adolescents are a major public health problem and evidence-based prevention programmes are greatly needed. We aimed to investigate the efficacy of school-based preventive interventions of suicidal behaviours. The Saving and Empowering Young Lives in Europe (SEYLE) study is a multicentre, cluster-randomised controlled trial. The SEYLE sample consisted of 11,110 adolescent pupils, median age 15 years (IQR 14-15), recruited from 168 schools in ten European Union countries. We randomly assigned the schools to one of three interventions or a control group. The interventions were: (1) Question, Persuade, and Refer (QPR), a gatekeeper training module targeting teachers and other school personnel, (2) the Youth Aware of Mental Health Programme (YAM) targeting pupils, and (3) screening by professionals (ProfScreen) with referral of at-risk pupils. Each school was randomly assigned by random number generator to participate in one intervention (or control) group only and was unaware of the interventions undertaken in the other three trial groups. The primary outcome measure was the number of suicide attempt(s) made by 3 month and 12 month follow-up. Analysis included all pupils with data available at each timepoint, excluding those who had ever attempted suicide or who had shown severe suicidal ideation during the 2 weeks before baseline. This study is registered with the German Clinical Trials Registry, number DRKS00000214. Between Nov 1, 2009, and Dec 14, 2010, 168 schools (11,110 pupils) were randomly assigned to interventions (40 schools [2692 pupils] to QPR, 45 [2721] YAM, 43 [2764] ProfScreen, and 40 [2933] control). No significant differences between intervention groups and the control group were recorded at the 3 month follow-up. At the 12 month follow-up, YAM was associated with a significant reduction of incident suicide attempts (odds ratios [OR] 0·45, 95% CI 0·24-0·85; p=0·014) and severe suicidal ideation (0·50, 0·27-0·92; p=0·025

  9. Slamming pressures on the bottom of a free-falling vertical wedge

    Science.gov (United States)

    Ikeda, C. M.; Judge, C. Q.

    2013-11-01

    High-speed planing boats are subjected to repeat impacts due to slamming, which can cause structural damage and injury to passengers. A first step in understanding and predicting the physics of a craft re-entering the water after becoming partially airborne is an experimental vertical drop test of a prismastic wedge (deadrise angle, β =20° beam, B = 300 mm; and length, L = 600 mm). The acrylic wedge was mounted to a rig allowing it to free-fall into a deep-water tank (5.2m × 5.2m × 4.2m deep) from heights 0 camera (1000 fps, resolution of 1920 × 1200 pixels) is mounted above the wedge model to record the wetted surface as the wedge descended below the free surface. The pressure measurements taken with both conventional surface pressure transducers and the pressure mapping system agree within 10% of the peak pressure values (0.7 bar, typical). Supported by the Office of Naval Research.

  10. Formal And Informal Macro-Regional Transport Clusters As A Primary Step In The Design And Implementation Of Cluster-Based Strategies

    Directory of Open Access Journals (Sweden)

    Nežerenko Olga

    2015-09-01

    Full Text Available The aim of the study is the identification of a formal macro-regional transport and logistics cluster and its development trends on a macro-regional level in 2007-2011 by means of the hierarchical cluster analysis. The central approach of the study is based on two concepts: 1 the concept of formal and informal macro-regions, and 2 the concept of clustering which is based on the similarities shared by the countries of a macro-region and tightly related to the concept of macro-region. The authors seek to answer the question whether the formation of a formal transport cluster could provide the BSR a stable competitive position in the global transportation and logistics market.

  11. Forces in Motzkin paths in a wedge

    International Nuclear Information System (INIS)

    Janse van Rensburg, E J

    2006-01-01

    Entropic forces in models of Motzkin paths in a wedge geometry are considered as models of forces in polymers in confined geometries. A Motzkin path in the square lattice is a path from the origin to a point in the line Y = X while it never visits sites below this line, and it is constrained to give unit length steps only in the north and east directions and steps of length √2 in the north-east direction. Motzkin path models may be generalized to ensembles of NE-oriented paths above the line Y = rX, where r > 0 is an irrational number. These are paths giving east, north and north-east steps from the origin in the square lattice, and confined to the r-wedge formed by the Y-axis and the line Y = rX. The generating function g r of these paths is not known, but if r > 1, then I determine its radius of convergence to be t r = min (r-1)/r≤y≤r/(r+1) [y y (1-r(1-y)) 1-r(1-y) (r(1-y)-y) r(1-y)-y ] and if r is an element of (0, 1), then t r = 1/3. The entropic force the path exerts on the line Y rX may be computed from this. An asymptotic expression for the force for large values of r is given by F(r) = log(2r)/r 2 - (1+2log(2r))/2r 3 + O (log(2r)/r 4 ). In terms of the vertex angle α of the r-wedge, the moment of the force about the origin has leading terms F(α) log(2/α) - (α/2)(1+2log(2/α)) + O(α 2 log(2/α)) as α → 0 + and F(α) = 0 if α is element of [π/4, π/2]. Moreover, numerical integration of the force shows that the total work done by closing the wedge is 1.085 07... lattice units. An alternative ensemble of NE-oriented paths may be defined by slightly changing the generating function g r . In this model, it is possible to determine closed-form expressions for the limiting free energy and the force. The leading term in an asymptotic expansions for this force agrees with the leading term in the asymptotic expansion of the above model, and the subleading term only differs by a factor of 2

  12. A geographical cluster randomised stepped wedge study of continuing medical education and cancer diagnosis in general practice

    DEFF Research Database (Denmark)

    Toftegaard, Berit; Bro, Flemming; Vedsted, Peter

    2014-01-01

    Alment praktiserende læger spiller en nøglerolle for tidlig diagnostik af kræft. Denne artikel beskriver en intervention i form af efteruddannelse af alment praktiserende læger i tidlig diagnostik af kræft. Artiklen beskriver identifikation af barrierer i almen praksis for tidlig diagnostik af...

  13. Rethinking wedges

    Science.gov (United States)

    Davis, Steven J.; Cao, Long; Caldeira, Ken; Hoffert, Martin I.

    2013-03-01

    stabilization wedges have become a ubiquitous unit in assessing different strategies to mitigate climate change (e.g. [2-5]). But the real and lasting potency of the wedge concept was in dividing the daunting problem of climate change into substantial but tractable portions of mitigation: Pacala and Socolow gave us a way to believe that the energy-carbon-climate problem was manageable. An unfortunate consequence of their paper, however, was to make the solution seem easy (see, e.g. [6, 7]). And in the meantime, the problem has grown. Since 2004, annual emissions have increased and their growth rate has accelerated, so that more than seven wedges would now be necessary to stabilize emissions and—more importantly—stabilizing emissions at current levels for 50 years does not appear compatible with Pacala and Socolow's target of an atmospheric CO2 concentration below 500 ppm nor the international community's goal of limiting the increase in global mean temperature to 2 °C more than the pre-industrial era. Here, we aim to revitalize the wedge concept by redefining what it means to 'solve the carbon and climate problem for the next 50 years'. This redefinition makes clear both the scale and urgency of innovating and deploying carbon-emissions-free energy technologies. 2. Solving the climate problem Stabilizing global climate requires decreasing CO2 emissions to near zero [8-11]. If emissions were to stop completely, global temperatures would quickly stabilize and decrease gradually over time [8, 12, 13]. But socioeconomic demands and dependence on fossil-fuel energy effectively commit us to many billions of tons of CO2 emissions [14], and at the timescale of centuries, each CO2 emission to the atmosphere contributes another increment to global warming: peak warming is proportional to cumulative CO2 emissions [15, 16]. Cumulative emissions, in turn, integrate all past emissions as well as those occurring during three distinct phases of mitigation: (1) slowing growth of

  14. Health-related hot topic detection in online communities using text clustering.

    Directory of Open Access Journals (Sweden)

    Yingjie Lu

    Full Text Available Recently, health-related social media services, especially online health communities, have rapidly emerged. Patients with various health conditions participate in online health communities to share their experiences and exchange healthcare knowledge. Exploring hot topics in online health communities helps us better understand patients' needs and interest in health-related knowledge. However, the statistical topic analysis employed in previous studies is becoming impractical for processing the rapidly increasing amount of online data. Automatic topic detection based on document clustering is an alternative approach for extracting health-related hot topics in online communities. In addition to the keyword-based features used in traditional text clustering, we integrate medical domain-specific features to represent the messages posted in online health communities. Three disease discussion boards, including boards devoted to lung cancer, breast cancer and diabetes, from an online health community are used to test the effectiveness of topic detection. Experiment results demonstrate that health-related hot topics primarily include symptoms, examinations, drugs, procedures and complications. Further analysis reveals that there also exist some significant differences among the hot topics discussed on different types of disease discussion boards.

  15. Feasibility and acceptability of training community health workers in ear and hearing care in Malawi: a cluster randomised controlled trial.

    Science.gov (United States)

    Mulwafu, Wakisa; Kuper, Hannah; Viste, Asgaut; Goplen, Frederik K

    2017-10-11

    To assess the feasibility and acceptability of training community health workers (CHWs) in ear and hearing care, and their ability to identify patients with ear and hearing disorders. Cluster randomised controlled trial (RCT). Health centres in Thyolo district, Malawi. Ten health centres participated, 5 intervention (29 CHWs) and 5 control (28 CHWs). Intervention CHWs received 3 days of training in primary ear and hearing care, while among control CHWs, training was delayed for 6 months. Both groups were given a pretest that assessed knowledge about ear and hearing care, only the intervention group was given the posttest on the third day of training. The intervention group was given 1 month to identify patients with ear and hearing disorders in their communities, and these people were screened for hearing disorders by ear, nose and throat clinical specialists. Primary outcome measure was improvement in knowledge of ear and hearing care among CHWs after the training. Secondary outcome measures were number of patients with ear or hearing disorders identified by CHWs and number recorded at health centres during routine activities, and the perceived feasibility and acceptability of the intervention. The average overall correct answers increased from 55% to 68% (95% CI 65 to 71) in the intervention group (phearing disorders were identified by CHWs and 860 patients attended the screening camps, of whom 400 had hearing loss (73 patients determined through bilateral fail on otoacoustic emissions, 327 patients through audiometry). Where cause could be determined, the most common cause of ear and hearing disorders was chronic suppurative otitis media followed by impacted wax. The intervention was perceived as feasible and acceptable to implement. Training was effective in improving the knowledge of CHW in ear and hearing care in Malawi and allowing them to identify patients with ear and hearing disorders. This intervention could be scaled up to other CHWs in low-income and

  16. Reducing child conduct problems and promoting social skills in a middle-income country: cluster randomised controlled trial†

    Science.gov (United States)

    Baker-Henningham, Helen; Scott, Stephen; Jones, Kelvyn; Walker, Susan

    2012-01-01

    Background There is an urgent need for effective, affordable interventions to prevent child mental health problems in low- and middle-income countries. Aims To determine the effects of a universal pre-school-based intervention on child conduct problems and social skills at school and at home. Method In a cluster randomised design, 24 community pre-schools in inner-city areas of Kingston, Jamaica, were randomly assigned to receive the Incredible Years Teacher Training intervention (n = 12) or to a control group (n = 12). Three children from each class with the highest levels of teacher-reported conduct problems were selected for evaluation, giving 225 children aged 3–6 years. The primary outcome was observed child behaviour at school. Secondary outcomes were child behaviour by parent and teacher report, child attendance and parents’ attitude to school. The study is registered as ISRCTN35476268. Results Children in intervention schools showed significantly reduced conduct problems (effect size (ES) = 0.42) and increased friendship skills (ES = 0.74) through observation, significant reductions to teacher-reported (ES = 0.47) and parent-reported (ES = 0.22) behaviour difficulties and increases in teacher-reported social skills (ES = 0.59) and child attendance (ES = 0.30). Benefits to parents’ attitude to school were not significant. Conclusions A low-cost, school-based intervention in a middle-income country substantially reduces child conduct problems and increases child social skills at home and at school. PMID:22500015

  17. Clinical Application of Wedge Factor

    International Nuclear Information System (INIS)

    Choi, Dong Rak; Ahn, Yong Chan; Huh, Sueng Jae

    1995-01-01

    Purpose : In general. The wedge factors which are used clinical practices are ignored of dependency on field sizes and depths. In this present, we investigated systematically the depth and field size dependency to determine the absorbed dose more accurately. Methods : The wedge factors for each wedge filter were measured at various depth (depth of Dmax, 5cm, 10cm, and 15cm) and field sizes (5 X 5cm, 10 X 10cm, 15 X 15cm, 20 X 20 cm) by using 4-,6-, and 10-MV X rays. By convention, wedge factors are determined by taking the ratio of the central axis ionization readings when the wedge filter is in place to those of the open field in same field size and measurement depth. In this present work, we determined the wedge factors for 4-, 6-, and 10-MV X rays from Clinac 600C and 2100C linear accelerators (manufactured by Varian Associates, Inc., Palo Alto, CA). To confirm that the wedge was centered., measurements were done with the two possible wedge position and various collimator orientations. Results : The standard deviations of measured values are within 0.3% and the depth dependence of wedge factor is greater for the lower energies. Especially, the variation of wedge factor is no less than 5% for 4- and 6- MV X rays with more than 45 .deg. wedge filter. But there seems to be a small dependence on field size. Conclusion : The results of this study show a dependence on the point of measurement. There also seems to be a small dependence on field size. And so, we should consider the depth and field size dependence in determining the wedge factors. If one wedge factor were to be used for each wedge filter, it seems that the measurement for a 10cm X 10cm field size at a depth of 10cm would be a reasonable choice

  18. Measurement of hepatic venous pressure gradient revisited: Catheter wedge vs balloon wedge techniques

    Directory of Open Access Journals (Sweden)

    S Timothy Chelliah

    2011-01-01

    Full Text Available Aims: To evaluate the accuracy of measurement of hepatic venous pressure gradient by catheter wedge as compared to balloon wedge (the gold standard. Materials and Methods: Forty-five patients having a clinical diagnosis of intrahepatic portal hypertension were subjected to the two different types of pressure measurements (catheter wedge and balloon wedge during transjugular liver biopsy under fluoroscopic guidance. Statistical Analysis: Spearman′s rank correlation coefficient, Bland-Altman plot for agreement, and single measure intraclass correlation were used for analysis of data. Results: There was a close correlation between the results obtained by both the techniques, with highly significant concordance (P < 0.0001. Hepatic venous pressure gradients as measured by the catheter wedge technique were either equal to or less than those obtained by the balloon wedge technique. Conclusions: The difference in hepatic venous pressure gradients measured by the two techniques is insignificant.

  19. Spatial resolution of wedge shaped silicon microstrip detectors

    International Nuclear Information System (INIS)

    Anticic, T.; Barnett, B.; Blumenfeld, B.; Chien, C.Y.; Fisher, P.; Gougas, A.; Krizmanic, J.; Madansky, L.; Newman, D.; Orndorff, J.; Pevsner, A.; Spangler, J.

    1995-01-01

    Several wedge-shaped silicon microstrip detectors with pitches from 30 to 100 μm have been designed by our group and beam tested at the CERN SPS. We find the spatial resolution σ becomes larger at the rate of 0.21 μm per 1 μm increase in pitch, but the number of strips per cluster remains about the same as the pitch varies from 30 to 100 μm. (orig.)

  20. Diffraction by an immersed elastic wedge

    CERN Document Server

    Croisille, Jean-Pierre

    1999-01-01

    This monograph presents the mathematical description and numerical computation of the high-frequency diffracted wave by an immersed elastic wave with normal incidence. The mathematical analysis is based on the explicit description of the principal symbol of the pseudo-differential operator connected with the coupled linear problem elasticity/fluid by the wedge interface. This description is subsequently used to derive an accurate numerical computation of diffraction diagrams for different incoming waves in the fluid, and for different wedge angles. The method can be applied to any problem of coupled waves by a wedge interface. This work is of interest for any researcher concerned with high frequency wave scattering, especially mathematicians, acousticians, engineers.

  1. Explaining the effects of an intervention designed to promote evidence-based diabetes care: a theory-based process evaluation of a pragmatic cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Kaner Eileen FS

    2008-11-01

    Full Text Available Abstract Background The results of randomised controlled trials can be usefully illuminated by studies of the processes by which they achieve their effects. The Theory of Planned Behaviour (TPB offers a framework for conducting such studies. This study used TPB to explore the observed effects in a pragmatic cluster randomised controlled trial of a structured recall and prompting intervention to increase evidence-based diabetes care that was conducted in three Primary Care Trusts in England. Methods All general practitioners and nurses in practices involved in the trial were sent a postal questionnaire at the end of the intervention period, based on the TPB (predictor variables: attitude; subjective norm; perceived behavioural control, or PBC. It focussed on three clinical behaviours recommended in diabetes care: measuring blood pressure; inspecting feet; and prescribing statins. Multivariate analyses of variance and multiple regression analyses were used to explore changes in cognitions and thereby better understand trial effects. Results Fifty-nine general medical practitioners and 53 practice nurses (intervention: n = 55, 41.98% of trial participants; control: n = 57, 38.26% of trial participants completed the questionnaire. There were no differences between groups in mean scores for attitudes, subjective norms, PBC or intentions. Control group clinicians had 'normatively-driven' intentions (i.e., related to subjective norm scores, whereas intervention group clinicians had 'attitudinally-driven' intentions (i.e., related to attitude scores for foot inspection and statin prescription. After controlling for effects of the three predictor variables, this group difference was significant for foot inspection behaviour (trial group × attitude interaction, beta = 0.72, p Conclusion Attitudinally-driven intentions are proposed to be more consistently translated into action than normatively-driven intentions. This proposition was supported by the

  2. Wedge gate valves selecting essentials in pipeline systems designing based on permissible operation parameters

    Science.gov (United States)

    Zakirnichnaya, M. M.; Kulsharipov, I. M.

    2017-10-01

    Wedge gate valves are widely used at the fuel and energy complex enterprises. The pipeline valves manufacturers indicate the safe operation resource according to the current regulatory and technical documentation. In this case, the resource value of the valve body strength calculation results is taken into consideration as the main structural part. However, it was determined that the wedge gate valves fail before the assigned resource due to the occurrence of conditions under which the wedge breaks in the hooks and, accordingly, the sealing integrity is not ensured. In this regard, it became necessary to assess the conditions under which the resource should be assigned not only to the valve body, but also to take into account the wedge durability. For this purpose, wedge resource calculations were made using the example of ZKL2 250-25 and ZKL2 300-25 valves using the ABAQUS software package FE-SAFE module under the technological parameters influence on the basis of their stressstrain state calculation results. Operating conditions, under which the wedge resource value is lower than the one set by the manufacturer, were determined. A technique for limiting the operating parameters for ensuring the wedge durability during the wedge gate valve assigned resource is proposed.

  3. A randomised controlled trial of a community-based healthy lifestyle program for overweight and obese adolescents: the Loozit® study protocol

    Directory of Open Access Journals (Sweden)

    Shah Smita

    2009-04-01

    Full Text Available Abstract Background There is a need to develop sustainable and clinically effective weight management interventions that are suitable for delivery in community settings where the vast majority of overweight and obese adolescents should be treated. This study aims to evaluate the effect of additional therapeutic contact as an adjunct to the Loozit® group program – a community-based, lifestyle intervention for overweight and lower grade obesity in adolescents. The additional therapeutic contact is provided via telephone coaching and either mobile phone Short Message Service or electronic mail, or both. Methods and design The study design is a two-arm randomised controlled trial that aims to recruit 168 overweight and obese 13–16 year olds (Body Mass Index z-score 1.0 to 2.5 in Sydney, Australia. Adolescents with secondary causes of obesity or significant medical illness are excluded. Participants are recruited via schools, media coverage, health professionals and several community organisations. Study arm one receives the Loozit® group weight management program (G. Study arm two receives the same Loozit® group weight management program plus additional therapeutic contact (G+ATC. The 'G' intervention consists of two phases. Phase 1 involves seven weekly group sessions held separately for adolescents and their parents. This is followed by phase 2 that involves a further seven group sessions held regularly, for adolescents only, until two years follow-up. Additional therapeutic contact is provided to adolescents in the 'G+ATC' study arm approximately once per fortnight during phase 2 only. Outcome measurements are assessed at 2, 12 and 24 months post-baseline and include: BMI z-score, waist z-score, metabolic profile indicators, physical activity, sedentary behaviour, eating patterns, and psychosocial well-being. Discussion The Loozit® study is the first randomised controlled trial of a community-based adolescent weight management

  4. A multicentre randomised controlled trial of day hospital-based falls prevention programme for a screened population of community-dwelling older people at high risk of falls

    OpenAIRE

    Conroy, Simon; Kendrick, Denise; Harwood, Rowan; Gladman, John; Coupland, Carol; Sach, Tracey; Drummond, Avril; Youde, Jane; Edmans, Judi; Masud, Tahir

    2010-01-01

    Objective: to determine the clinical effectiveness of a day hospital-delivered multifactorial falls prevention programme, for community-dwelling older people at high risk of future falls identified through a screening process. Design: multicentre randomised controlled trial. Setting: eight general practices and three day hospitals based in the East Midlands, UK. Participants: three hundred and sixty-four participants, mean age 79 years, with a median of three falls risk factors per person at ...

  5. NEWHINTS cluster randomised trial to evaluate the impact on neonatal mortality in rural Ghana of routine home visits to provide a package of essential newborn care interventions in the third trimester of pregnancy and the first week of life: trial protocol.

    Science.gov (United States)

    Kirkwood, Betty R; Manu, Alexander; Tawiah-Agyemang, Charlotte; ten Asbroek, Guus; Gyan, Thomas; Weobong, Benedict; Lewandowski, R Eric; Soremekun, Seyi; Danso, Samuel; Pitt, Catherine; Hanson, Kara; Owusu-Agyei, Seth; Hill, Zelee

    2010-05-17

    Tackling neonatal mortality is essential for the achievement of the child survival millennium development goal. There are just under 4 million neonatal deaths, accounting for 38% of the 10.8 million deaths among children younger than 5 years of age taking place each year; 99% of these occur in low- and middle-income countries where a large proportion of births take place at home, and where postnatal care for mothers and neonates is either not available or is of poor quality. WHO and UNICEF have issued a joint statement calling for governments to implement "Home visits for the newborn child: a strategy to improve survival", following several studies in South Asia which achieved substantial reductions in neonatal mortality through community-based approaches. However, their feasibility and effectiveness have not yet been evaluated in Africa. The Newhints study aims to do this in Ghana and to develop a feasible and sustainable community-based approach to improve newborn care practices, and by so doing improve neonatal survival. Newhints is an integrated intervention package based on extensive formative research, and developed in close collaboration with seven District Health Management Teams (DHMTs) in Brong Ahafo Region. The core component is training the existing community based surveillance volunteers (CBSVs) to identify pregnant women and to conduct two home visits during pregnancy and three in the first week of life to address essential care practices, and to assess and refer very low birth weight and sick babies. CBSVs are supported by a set of materials, regular supervisory visits, incentives, sensitisation activities with TBAs, health facility staff and communities, and providing training for essential newborn care in health facilities.Newhints is being evaluated through a cluster randomised controlled trial, and intention to treat analyses. The clusters are 98 supervisory zones; 49 have been randomised for implementation of the Newhints intervention, with the

  6. NEWHINTS cluster randomised trial to evaluate the impact on neonatal mortality in rural Ghana of routine home visits to provide a package of essential newborn care interventions in the third trimester of pregnancy and the first week of life: trial protocol

    Directory of Open Access Journals (Sweden)

    Pitt Catherine

    2010-05-01

    Full Text Available Abstract Background Tackling neonatal mortality is essential for the achievement of the child survival millennium development goal. There are just under 4 million neonatal deaths, accounting for 38% of the 10.8 million deaths among children younger than 5 years of age taking place each year; 99% of these occur in low- and middle-income countries where a large proportion of births take place at home, and where postnatal care for mothers and neonates is either not available or is of poor quality. WHO and UNICEF have issued a joint statement calling for governments to implement "Home visits for the newborn child: a strategy to improve survival", following several studies in South Asia which achieved substantial reductions in neonatal mortality through community-based approaches. However, their feasibility and effectiveness have not yet been evaluated in Africa. The Newhints study aims to do this in Ghana and to develop a feasible and sustainable community-based approach to improve newborn care practices, and by so doing improve neonatal survival. Methods Newhints is an integrated intervention package based on extensive formative research, and developed in close collaboration with seven District Health Management Teams (DHMTs in Brong Ahafo Region. The core component is training the existing community based surveillance volunteers (CBSVs to identify pregnant women and to conduct two home visits during pregnancy and three in the first week of life to address essential care practices, and to assess and refer very low birth weight and sick babies. CBSVs are supported by a set of materials, regular supervisory visits, incentives, sensitisation activities with TBAs, health facility staff and communities, and providing training for essential newborn care in health facilities. Newhints is being evaluated through a cluster randomised controlled trial, and intention to treat analyses. The clusters are 98 supervisory zones; 49 have been randomised for

  7. Process evaluation of a cluster-randomised trial testing a pressure ulcer prevention care bundle: a mixed-methods study.

    Science.gov (United States)

    Roberts, Shelley; McInnes, Elizabeth; Bucknall, Tracey; Wallis, Marianne; Banks, Merrilyn; Chaboyer, Wendy

    2017-02-13

    As pressure ulcers contribute to significant patient burden and increased health care costs, their prevention is a clinical priority. Our team developed and tested a complex intervention, a pressure ulcer prevention care bundle promoting patient participation in care, in a cluster-randomised trial. The UK Medical Research Council recommends process evaluation of complex interventions to provide insight into why they work or fail and how they might be improved. This study aimed to evaluate processes underpinning implementation of the intervention and explore end-users' perceptions of it, in order to give a deeper understanding of its effects. A pre-specified, mixed-methods process evaluation was conducted as an adjunct to the main trial, guided by a framework for process evaluation of cluster-randomised trials. Data was collected across eight Australian hospitals but mainly focused on the four intervention hospitals. Quantitative and qualitative data were collected across the evaluation domains: recruitment, reach, intervention delivery and response to intervention, at both cluster and individual patient level. Quantitative data were analysed using descriptive and inferential statistics. Qualitative data were analysed using thematic analysis. In the context of the main trial, which found a 42% reduction in risk of pressure ulcer with the intervention that was not significant after adjusting for clustering and covariates, this process evaluation provides important insights. Recruitment and reach among clusters and individuals was high, indicating that patients, nurses and hospitals are willing to engage with a pressure ulcer prevention care bundle. Of 799 intervention patients in the trial, 96.7% received the intervention, which took under 10 min to deliver. Patients and nurses accepted the care bundle, recognising benefits to it and describing how it enabled participation in pressure ulcer prevention (PUP) care. This process evaluation found no major failures

  8. Clinical implementation of enhanced dynamic wedge

    International Nuclear Information System (INIS)

    Klein, Eric E.; Zhu Xiaorong; Low, Daniel A.; Drzymala, Robert E.; Harms, William B.; Purdy, James A.

    1996-01-01

    Purpose/Objective: Our clinic has been using dynamic wedge since 1993. We appreciate the customized wedge shaped distributions (independent of field size) and the positive aspects of replacing filters with dynamic jaw motion. Varian recently introduced enhanced dynamic wedge (EDW) software. The EDW can be delivered over; a 30 cm field, asymmetric fields (in both wedged and non-wedged directions), and additional wedge angles (10, 15, 20, 25, 30, 45, 60). The EDW software creates customized segmented treatment tables (STTs) for the desired wedge angle and field size. The STT is created from a 'golden' fluence profile of 60 deg. over 30 cm. The wedge STT is derived using ratio-of-tangents and the truncated field segment extracted from the 'golden' table. A review of our dosimetric studies will be presented as well as a discussion of clinical implementation issues including treatment planning and quality assurance. Methods and Materials: We tested a set of angle and field size combinations chosen to encompass clinical needs. The wedge factor (WF) was measured using an ionization chamber along central axis for symmetric fields ranging from 4 to 20 cm, and asymmetric fields to 30 cm. The non-wedged field dimension was found to be inconsequential. An algorithm was developed to predict the wedge factor for any angle and field dimension. Isodoses were measured with film and used for profile evaluation and treatment planning development. The 'golden' fluence table was used to create a universal 60 deg. 'physical' wedge for planning. The universal wedge is combined with an open field (to derive intermediate wedge angles) and blocked according to the treatment field segment. A quality assurance program was developed that relies on multi-point diode measurements. Results: We found the WF is a function of wedge angle and field settings of the final sweep position. There is a nearly linear dependence of WF vs. field size thus allowing a minimal WF table. This eliminates a

  9. Effect of water quality, sanitation, hand washing, and nutritional interventions on child development in rural Bangladesh (WASH Benefits Bangladesh): a cluster-randomised controlled trial.

    Science.gov (United States)

    Tofail, Fahmida; Fernald, Lia Ch; Das, Kishor K; Rahman, Mahbubur; Ahmed, Tahmeed; Jannat, Kaniz K; Unicomb, Leanne; Arnold, Benjamin F; Ashraf, Sania; Winch, Peter J; Kariger, Patricia; Stewart, Christine P; Colford, John M; Luby, Stephen P

    2018-04-01

    Poor nutrition and hygiene make children vulnerable to delays in growth and development. We aimed to assess the effects of water quality, sanitation, handwashing, and nutritional interventions individually or in combination on the cognitive, motor, and language development of children in rural Bangladesh. In this cluster-randomised controlled trial, we enrolled pregnant women in their first or second trimester from rural villages of Gazipur, Kishoreganj, Mymensingh, and Tangail districts of central Bangladesh, with an average of eight women per cluster. Groups of eight geographically adjacent clusters were block-randomised, using a random number generator, into six intervention groups (all of which received weekly visits from a community health promoter for the first 6 months and every 2 weeks for the next 18 months) and a double-sized control group (no intervention or health promoter visit). The six intervention groups were: chlorinated drinking water; improved sanitation; handwashing with soap; combined water, sanitation, and handwashing; improved nutrition through counselling and provision of lipid-based nutrient supplements; and combined water, sanitation, handwashing, and nutrition. Here, we report on the prespecified secondary child development outcomes: gross motor milestone achievement assessed with the WHO module at age 1 year, and communication, gross motor, personal social, and combined scores measured by the Extended Ages and Stages Questionnaire (EASQ) at age 2 years. Masking of participants was not possible. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01590095. Between May 31, 2012, and July 7, 2013, 5551 pregnant women residing in 720 clusters were enrolled. Index children of 928 (17%) enrolled women were lost to follow-up in year 1 and an additional 201 (3%) in year 2. 4757 children were assessed at 1 year and 4403 at 2 years. At year 1, compared with the control group, the combined water

  10. Knowledge between communities of practice and firms in clusters

    DEFF Research Database (Denmark)

    Reinau, Kristian Hegner

    . This paper presents a case study in which theory about knowledge, communities of practice and networks is used to understand how knowledge is developed in high-tech companies placed in a cluster. The case study illuminates how internal and external relations and factors affect the knowledge development...... which factors that affect the knowledge development process in communities in the case companies. By analysing the interplay between formal and informal relations utilized by the companies, the knowledge embedded in the persons constituting the communities as well as knowledge embedded in objects used......Currently there is growing focus on how cluster internal and cluster external relations affect the creation of knowledge in companies placed in clusters. However, the current theories on this topic are too simple and the interplay between internal and external relations is relatively unknown...

  11. Home and Community-Based Service Use by Vulnerable Older Adults.

    Science.gov (United States)

    Weaver, Raven H; Roberto, Karen A

    2017-06-01

    The purpose of this study was to identify different types of clients who use home and community-based services. Enrollment characteristics of 76 clients at risk of nursing home placement and Medicaid spend-down who were enrolled in the Virginia Community Living Program were analyzed. Two-step cluster analysis identified 4 groups of service users. Enabling resources (caregiver relationship to participant, participant living arrangement, and length of time caregiver provided assistance to participant) and disability type (physical, cognitive, traumatic brain injury, or other) differentiated the client groups. Groups differed on average service cost per day and likelihood of nursing home placement if services were not provided. Findings point to the value of having practitioners assist vulnerable clients in tailoring services to meet different care needs and the need for refining policies guiding home and community-based care. © The Author 2015. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  12. Quasi-experimental designs in practice-based research settings: design and implementation considerations.

    Science.gov (United States)

    Handley, Margaret A; Schillinger, Dean; Shiboski, Stephen

    2011-01-01

    Although randomized controlled trials are often a gold standard for determining intervention effects, in the area of practice-based research (PBR), there are many situations in which individual randomization is not possible. Alternative approaches to evaluating interventions have received increased attention, particularly those that can retain elements of randomization such that they can be considered "controlled" trials. Methodological design elements and practical implementation considerations for two quasi-experimental design approaches that have considerable promise in PBR settings--the stepped-wedge design, and a variant of this design, a wait-list cross-over design, are presented along with a case study from a recent PBR intervention for patients with diabetes. PBR-relevant design features include: creation of a cohort over time that collects control data but allows all participants (clusters or patients) to receive the intervention; staggered introduction of clusters; multiple data collection points; and one-way cross-over into the intervention arm. Practical considerations include: randomization versus stratification, training run in phases; and extended time period for overall study completion. Several design features of practice based research studies can be adapted to local circumstances yet retain elements to improve methodological rigor. Studies that utilize these methods, such as the stepped-wedge design and the wait-list cross-over design, can increase the evidence base for controlled studies conducted within the complex environment of PBR.

  13. Effect of non-monetary incentives on uptake of couples' counselling and testing among clients attending mobile HIV services in rural Zimbabwe: a cluster-randomised trial.

    Science.gov (United States)

    Sibanda, Euphemia L; Tumushime, Mary; Mufuka, Juliet; Mavedzenge, Sue Napierala; Gudukeya, Stephano; Bautista-Arredondo, Sergio; Hatzold, Karin; Thirumurthy, Harsha; McCoy, Sandra I; Padian, Nancy; Copas, Andrew; Cowan, Frances M

    2017-09-01

    Couples' HIV testing and counselling (CHTC) is associated with greater engagement with HIV prevention and care than individual testing and is cost-effective, but uptake remains suboptimal. Initiating discussion of CHTC might result in distrust between partners. Offering incentives for CHTC could change the focus of the pre-test discussion. We aimed to determine the impact of incentives for CHTC on uptake of couples testing and HIV case diagnosis in rural Zimbabwe. In this cluster-randomised trial, 68 rural communities (the clusters) in four districts receiving mobile HIV testing services were randomly assigned (1:1) to incentives for CHTC or not. Allocation was not masked to participants and researchers. Randomisation was stratified by district and proximity to a health facility. Within each stratum random permutation was done to allocate clusters to the study groups. In intervention communities, residents were informed that couples who tested together could select one of three grocery items worth US$1·50. Standard mobilisation for testing was done in comparison communities. The primary outcome was the proportion of individuals testing with a partner. Analysis was by intention to treat. 3 months after CHTC, couple-testers from four communities per group individually completed a telephone survey to evaluate any social harms resulting from incentives or CHTC. The effect of incentives on CHTC was estimated using logistic regression with random effects adjusting for clustering. The trial was registered with the Pan African Clinical Trial Registry, number PACTR201606001630356. From May 26, 2015, to Jan 29, 2016, of 24 679 participants counselled with data recorded, 14 099 (57·1%) were in the intervention group and 10 580 (42·9%) in the comparison group. 7852 (55·7%) testers in the intervention group versus 1062 (10·0%) in the comparison group tested with a partner (adjusted odds ratio 13·5 [95% CI 10·5-17·4]). Among 427 (83·7%) of 510 eligible

  14. Effects of quality improvement in health facilities and community mobilization through women's groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial.

    Science.gov (United States)

    Colbourn, Tim; Nambiar, Bejoy; Bondo, Austin; Makwenda, Charles; Tsetekani, Eric; Makonda-Ridley, Agnes; Msukwa, Martin; Barker, Pierre; Kotagal, Uma; Williams, Cassie; Davies, Ros; Webb, Dale; Flatman, Dorothy; Lewycka, Sonia; Rosato, Mikey; Kachale, Fannie; Mwansambo, Charles; Costello, Anthony

    2013-09-01

    Maternal, perinatal and neonatal mortality remains high in low-income countries. We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi. We evaluated a rural participatory women's group community intervention (CI) and a quality improvement intervention at health centres (FI) via a two-by-two factorial cluster randomized controlled trial. Consenting pregnant women were followed-up to 2 months after birth using key informants. Primary outcomes were maternal, perinatal and neonatal mortality. Clusters were health centre catchment areas assigned using stratified computer-generated randomization. Following exclusions, including non-birthing facilities, 61 clusters were analysed: control (17 clusters, 4912 births), FI (15, 5335), CI (15, 5080) and FI + CI (14, 5249). This trial was registered as International Standard Randomised Controlled Trial [ISRCTN18073903]. Outcomes for 14,576 and 20,576 births were recorded during baseline (June 2007-September 2008) and intervention (October 2008-December 2010) periods. For control, FI, CI and FI + CI clusters neonatal mortality rates were 34.0, 28.3, 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2, 55.1, 48.0 and 48.4 per 1000 births, during the intervention period. Adjusting for clustering and stratification, the neonatal mortality rate was 22% lower in FI + CI than control clusters (OR = 0.78, 95% CI 0.60-1.01), and the perinatal mortality rate was 16% lower in CI clusters (OR = 0.84, 95% CI 0.72-0.97). We did not observe any intervention effects on maternal mortality. Despite implementation problems, a combined community and facility approach using participatory women's groups and quality improvement at health centres reduced newborn mortality in rural Malawi.

  15. Improving outcomes of preschool language delay in the community: protocol for the Language for Learning randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Wake Melissa

    2012-07-01

    Full Text Available Abstract Background Early language delay is a high-prevalence condition of concern to parents and professionals. It may result in lifelong deficits not only in language function, but also in social, emotional/behavioural, academic and economic well-being. Such delays can lead to considerable costs to the individual, the family and to society more widely. The Language for Learning trial tests a population-based intervention in 4 year olds with measured language delay, to determine (1 if it improves language and associated outcomes at ages 5 and 6 years and (2 its cost-effectiveness for families and the health care system. Methods/Design A large-scale randomised trial of a year-long intervention targeting preschoolers with language delay, nested within a well-documented, prospective, population-based cohort of 1464 children in Melbourne, Australia. All children received a 1.25-1.5 hour formal language assessment at their 4th birthday. The 200 children with expressive and/or receptive language scores more than 1.25 standard deviations below the mean were randomised into intervention or ‘usual care’ control arms. The 20-session intervention program comprises 18 one-hour home-based therapeutic sessions in three 6-week blocks, an outcome assessment, and a final feed-back/forward planning session. The therapy utilises a ‘step up-step down’ therapeutic approach depending on the child’s language profile, severity and progress, with standardised, manualised activities covering the four language development domains of: vocabulary and grammar; narrative skills; comprehension monitoring; and phonological awareness/pre-literacy skills. Blinded follow-up assessments at ages 5 and 6 years measure the primary outcome of receptive and expressive language, and secondary outcomes of vocabulary, narrative, and phonological skills. Discussion A key strength of this robust study is the implementation of a therapeutic framework that provides a standardised

  16. The value of episodic, intensive blood glucose monitoring in non-insulin treated persons with Type 2 Diabetes: design of the Structured Testing Program (STeP) study, a cluster-randomised, clinical trial [NCT00674986].

    Science.gov (United States)

    Polonsky, William; Fisher, Lawrence; Schikman, Charles; Hinnen, Deborah; Parkin, Christopher; Jelsovsky, Zhihong; Amstutz, Linda; Schweitzer, Matthias; Wagner, Robin

    2010-05-18

    The value and utility of self-monitoring of blood glucose (SMBG) in non-insulin treated T2DM has yet to be clearly determined. Findings from studies in this population have been inconsistent, due mainly to design differences and limitations, including the prescribed frequency and timing of SMBG, role of the patient and physician in responding to SMBG results, inclusion criteria that may contribute to untoward floor effects, subject compliance, and cross-arm contamination. We have designed an SMBG intervention study that attempts to address these issues. The Structured Testing Program (STeP) study is a 12-month, cluster-randomised, multi-centre clinical trial to evaluate whether poorly controlled (HbA1c >or= 7.5%), non-insulin treated T2DM patients will benefit from a comprehensive, integrated physician/patient intervention using structured SMBG in US primary care practices. Thirty-four practices will be recruited and randomly assigned to an active control group (ACG) that receives enhanced usual care or to an enhanced usual care group plus structured SMBG (STG). A total of 504 patients will be enrolled; eligible patients at each site will be randomly selected using a defined protocol. Anticipated attrition of 20% will yield a sample size of at least 204 per arm, which will provide a 90% power to detect a difference of at least 0.5% in change from baseline in HbA1c values, assuming a common standard deviation of 1.5%. Differences in timing and degree of treatment intensification, cost effectiveness, and changes in patient self-management behaviours, mood, and quality of life (QOL) over time will also be assessed. Analysis of change in HbA1c and other dependent variables over time will be performed using both intent-to-treat and per protocol analyses. Trial results will be available in 2010. The intervention and trial design builds upon previous research by emphasizing appropriate and collaborative use of SMBG by both patients and physicians. Utilization of per

  17. The value of episodic, intensive blood glucose monitoring in non-insulin treated persons with type 2 diabetes: Design of the Structured Testing Program (STeP Study, a cluster-randomised, clinical trial [NCT00674986

    Directory of Open Access Journals (Sweden)

    Jelsovsky Zhihong

    2010-05-01

    Full Text Available Abstract Background The value and utility of self-monitoring of blood glucose (SMBG in non-insulin treated T2DM has yet to be clearly determined. Findings from studies in this population have been inconsistent, due mainly to design differences and limitations, including the prescribed frequency and timing of SMBG, role of the patient and physician in responding to SMBG results, inclusion criteria that may contribute to untoward floor effects, subject compliance, and cross-arm contamination. We have designed an SMBG intervention study that attempts to address these issues. Methods/design The Structured Testing Program (STeP study is a 12-month, cluster-randomised, multi-centre clinical trial to evaluate whether poorly controlled (HbA1c ≥ 7.5%, non-insulin treated T2DM patients will benefit from a comprehensive, integrated physician/patient intervention using structured SMBG in US primary care practices. Thirty-four practices will be recruited and randomly assigned to an active control group (ACG that receives enhanced usual care or to an enhanced usual care group plus structured SMBG (STG. A total of 504 patients will be enrolled; eligible patients at each site will be randomly selected using a defined protocol. Anticipated attrition of 20% will yield a sample size of at least 204 per arm, which will provide a 90% power to detect a difference of at least 0.5% in change from baseline in HbA1c values, assuming a common standard deviation of 1.5%. Differences in timing and degree of treatment intensification, cost effectiveness, and changes in patient self-management behaviours, mood, and quality of life (QOL over time will also be assessed. Analysis of change in HbA1c and other dependent variables over time will be performed using both intent-to-treat and per protocol analyses. Trial results will be available in 2010. Discussion The intervention and trial design builds upon previous research by emphasizing appropriate and collaborative use of

  18. Universal Internet-based prevention for alcohol and cannabis use reduces truancy, psychological distress and moral disengagement: a cluster randomised controlled trial.

    Science.gov (United States)

    Newton, Nicola C; Andrews, Gavin; Champion, Katrina E; Teesson, Maree

    2014-08-01

    A universal Internet-based preventive intervention has been shown to reduce alcohol and cannabis use. The aim of this study was to examine if this program could also reduce risk-factors associated with substance use in adolescents. A cluster randomised controlled trial was conducted in Sydney, Australia in 2007-2008 to assess the effectiveness of the Internet-based Climate Schools: Alcohol and Cannabis course. The evidence-based course, aimed at reducing alcohol and cannabis use, consists of two sets of six lessons delivered approximately six months apart. A total of 764 students (mean 13.1years) from 10 secondary schools were randomly allocated to receive the preventive intervention (n=397, five schools), or their usual health classes (n=367, five schools) over the year. Participants were assessed at baseline, immediately post, and six and twelve months following the intervention on their levels of truancy, psychological distress and moral disengagement. Compared to the control group, students in the intervention group showed significant reductions in truancy, psychological distress and moral disengagement up to twelve months following completion of the intervention. These intervention effects indicate that Internet-based preventive interventions designed to prevent alcohol and cannabis use can concurrently reduce risk-factors associated with substance use in adolescents. Australian Clinical Trials Registry ACTRN: 012607000312448. Copyright © 2014 Elsevier Inc. All rights reserved.

  19. Cluster-based spectrum sensing for cognitive radios with imperfect channel to cluster-head

    KAUST Repository

    Ben Ghorbel, Mahdi

    2012-04-01

    Spectrum sensing is considered as the first and main step for cognitive radio systems to achieve an efficient use of spectrum. Cooperation and clustering among cognitive radio users are two techniques that can be employed with spectrum sensing in order to improve the sensing performance by reducing miss-detection and false alarm. In this paper, within the framework of a clustering-based cooperative spectrum sensing scheme, we study the effect of errors in transmitting the local decisions from the secondary users to the cluster heads (or the fusion center), while considering non-identical channel conditions between the secondary users. Closed-form expressions for the global probabilities of detection and false alarm at the cluster head are derived. © 2012 IEEE.

  20. Cluster-based spectrum sensing for cognitive radios with imperfect channel to cluster-head

    KAUST Repository

    Ben Ghorbel, Mahdi; Nam, Haewoon; Alouini, Mohamed-Slim

    2012-01-01

    Spectrum sensing is considered as the first and main step for cognitive radio systems to achieve an efficient use of spectrum. Cooperation and clustering among cognitive radio users are two techniques that can be employed with spectrum sensing in order to improve the sensing performance by reducing miss-detection and false alarm. In this paper, within the framework of a clustering-based cooperative spectrum sensing scheme, we study the effect of errors in transmitting the local decisions from the secondary users to the cluster heads (or the fusion center), while considering non-identical channel conditions between the secondary users. Closed-form expressions for the global probabilities of detection and false alarm at the cluster head are derived. © 2012 IEEE.

  1. Update to a protocol for a feasibility cluster randomised controlled trial of a peer-led school-based intervention to increase the physical activity of adolescent girls (PLAN-A).

    Science.gov (United States)

    Sebire, Simon J; Edwards, Mark J; Campbell, Rona; Jago, Russell; Kipping, Ruth; Banfield, Kathryn; Kadir, Bryar; Garfield, Kirsty; Lyons, Ronan A; Blair, Peter S; Hollingworth, William

    2016-01-01

    Physical activity levels are low amongst adolescent girls, and this population faces specific barriers to being active. Peer influences on health behaviours are important in adolescence, and peer-led interventions might hold promise to change behaviour. This paper describes the protocol for a feasibility cluster randomised controlled trial of Peer-Led physical Activity iNtervention for Adolescent girls (PLAN-A), a peer-led intervention aimed at increasing adolescent girls' physical activity levels. In addition, this paper describes an update that has been made to the protocol for the PLAN-A feasibility cluster randomised controlled trial. A two-arm cluster randomised feasibility trial will be conducted in six secondary schools (intervention n  = 4; control n  = 2) with year 8 (12-13 years old) girls. The intervention will operate at a year group level and consist of year 8 girls nominating influential peers within their year group to become peer supporters. Approximately 15% of the cohort will receive 3 days of training about physical activity and interpersonal communication skills. Peer supporters will then informally diffuse messages about physical activity amongst their friends for 10 weeks. Data will be collected at baseline (time 0 (T0)), immediately after the intervention (time 1 (T1)) and 12 months after baseline measures (time 2 (T2)). In this feasibility trial, the primary interest is in the recruitment of schools and participants (both year 8 girls and peer supporters), delivery and receipt of the intervention, data provision rates and identifying the cost categories for future economic analysis. Physical activity will be assessed using 7-day accelerometry, with the likely primary outcome in a fully powered trial being daily minutes of moderate-to-vigorous physical activity. Participants will also complete psychosocial questionnaires at each time point: assessing motivation, self-esteem and peer physical activity norms. Data analysis will be

  2. Growth effects of exclusive breastfeeding promotion by peer counsellors in sub-Saharan Africa: the cluster-randomised PROMISE EBF trial.

    Science.gov (United States)

    Engebretsen, Ingunn Marie Stadskleiv; Jackson, Debra; Fadnes, Lars Thore; Nankabirwa, Victoria; Diallo, Abdoulaye Hama; Doherty, Tanya; Lombard, Carl; Swanvelder, Sonja; Nankunda, Jolly; Ramokolo, Vundli; Sanders, David; Wamani, Henry; Meda, Nicolas; Tumwine, James K; Ekström, Eva-Charlotte; Van de Perre, Philippe; Kankasa, Chipepo; Sommerfelt, Halvor; Tylleskär, Thorkild

    2014-06-21

    In this multi-country cluster-randomized behavioural intervention trial promoting exclusive breastfeeding (EBF) in Africa, we compared growth of infants up to 6 months of age living in communities where peer counsellors promoted EBF with growth in those infants living in control communities. A total of 82 clusters in Burkina Faso, Uganda and South Africa were randomised to either the intervention or the control arm. Feeding data and anthropometric measurements were collected at visits scheduled 3, 6, 12 and 24 weeks post-partum. We calculated weight-for-length (WLZ), length-for-age (LAZ) and weight-for-age (WAZ) z-scores. Country specific adjusted Least Squares Means with 95% confidence intervals (CI) based on a longitudinal analysis are reported. Prevalence ratios (PR) for the association between peer counselling for EBF and wasting (WLZ economic status, the mean WLZ at 24 weeks were in Burkina Faso -0.20 (95% CI -0.39 to -0.01) and in Uganda -0.23 (95% CI -0.43 to -0.03) lower in the intervention than in the control arm. In South Africa the mean WLZ at 24 weeks was 0.23 (95% CI 0.03 to 0.43) greater in the intervention than in the control arm. Differences in LAZ between the study arms were small and not statistically significant. In Uganda, infants in the intervention arm were more likely to be wasted compared to those in the control arm at 24 weeks (PR 2.36; 95% CI 1.11 to 5.00). Differences in wasting in South Africa and Burkina Faso and stunting and underweight in all three countries were small and not significantly different. There were small differences in mean anthropometric indicators between the intervention and control arms in the study, but in Uganda and Burkina Faso, a tendency to slightly lower ponderal growth (weight-for-length z-scores) was found in the intervention arms. ClinicalTrials.gov: NCT00397150.

  3. Return-to-work intervention versus usual care for sick-listed employees : Health-economic investment appraisal alongside a cluster randomised trial

    NARCIS (Netherlands)

    Lokman, S.; Volker, D.; Zijlstra-Vlasveld, M.C.; Brouwers, E.P.M.; Boon, B.; Beekman, A.T.; Smit, F.; van der Feltz-Cornelis, C.M.

    2017-01-01

    To evaluate the health-economic costs and benefits of a guided eHealth intervention (E-health module embedded in Collaborative Occupational healthcare (ECO)) encouraging sick-listed employees to a faster return to work. A two-armed cluster randomised trial with occupational physicians (OPs) (n=62),

  4. 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

  5. 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

  6. Mantle wedge serpentinization effects on slab dips

    Directory of Open Access Journals (Sweden)

    Eh Tan

    2017-01-01

    Full Text Available The mechanical coupling between a subducting slab and the overlying mantle wedge is an important factor in controlling the subduction dip angle and the flow in mantel wedge. This paper investigates the role of the amount of mantle serpentinization on the subduction zone evolution. With numerical thermos-mechanical models with elasto-visco-plastic rheology, we vary the thickness and depth extent of mantle serpentinization in the mantle wedge to control the degree of coupling between the slab and mantle wedge. A thin serpentinized mantle layer is required for stable subduction. For models with stable subduction, we find that the slab dip is affected by the down-dip extent and the mantle serpentinization thickness. A critical down-dip extent exists in mantle serpentinization, determined by the thickness of the overriding lithosphere. If the down-dip extent does not exceed the critical depth, the slab is partially coupled to the overriding lithosphere and has a constant dip angle regardless of the mantle serpentinization thickness. However, if the down-dip extent exceeds the critical depth, the slab and the base of the overriding lithosphere would be separated and decoupled by a thick layer of serpentinized peridotite. This allows further slab bending and results in steeper slab dip. Increasing mantle serpentinization thickness will also result in larger slab dip. We also find that with weak mantle wedge, there is no material flowing from the asthenosphere into the serpentinized mantle wedge. All of these results indicate that serpentinization is an important ingredient when studying the subduction dynamics in the mantle wedge.

  7. Epistemic communities and cluster dynamics

    DEFF Research Database (Denmark)

    Håkanson, Lars

    2003-01-01

    This paper questions the prevailing notions that firms within industrial clusters have privi-leged access to `tacit knowledge' that is unavailable - or available only at high cost - to firms located elsewhere, and that such access provides competitive advantages that help to explain the growth...... and development of both firms and regions. It outlines a model of cluster dynam-ics emphasizing two mutually interdependent processes: the concentration of specialized and complementary epistemic communities, on the one hand, and entrepreneurship and a high rate of new firm formation on the other....

  8. The REFANI Pakistan study--a cluster randomised controlled trial of the effectiveness and cost-effectiveness of cash-based transfer programmes on child nutrition status: study protocol.

    Science.gov (United States)

    Fenn, Bridget; Sangrasi, Ghulam Murtaza; Puett, Chloe; Trenouth, Lani; Pietzsch, Silke

    2015-10-12

    Cash-based transfer programmes are an emerging strategy in the prevention of wasting in children, especially targeted at vulnerable households during periods of food insecurity or during emergencies. However, the evidence surrounding the use of either cash or voucher transfer programmes in the humanitarian context and on nutritional outcomes is elusive. More evidence is needed not only to inform the global community of practice on best practices in humanitarian settings, but also to help strengthen national mitigation responses. The Research for Food Assistance on Nutrition Impact Pakistan study (REFANI-P) sets out to evaluate the impact of three cash-based interventions on nutritional outcomes in children aged less than five years from poor and very poor households in Dadu District. This four-arm parallel cluster randomised controlled trial is set among Action Against Hunger (ACF) programme villages in Dadu District, Sindh Province. Mothers are the target recipients of either seasonal unconditional cash transfers or fresh food vouchers. A comparison group receives 'standard care' provided by the ACF programme to which all groups have the same access. The primary outcomes are prevalence of wasting and mean weight-for-height Z-score (WHZ) in children. Impact will be assessed at 6 months and at 1 year from baseline. Using a theory-based approach we will determine 'how' the different interventions work by looking at the processes involved and the impact pathways following the theory of change developed for this context. Quantitative and qualitative data are collected on morbidity, health seeking, hygiene and nutrition behaviours, dietary diversity, haemoglobin concentration, women's empowerment, household food security and expenditures and social capital. The direct and indirect costs of each intervention borne by the implementing organisation and their partners as well as by beneficiaries and their communities are also assessed. The results of this trial will provide

  9. Effects of quality improvement in health facilities and community mobilization through women’s groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial

    Science.gov (United States)

    Colbourn, Tim; Nambiar, Bejoy; Bondo, Austin; Makwenda, Charles; Tsetekani, Eric; Makonda-Ridley, Agnes; Msukwa, Martin; Barker, Pierre; Kotagal, Uma; Williams, Cassie; Davies, Ros; Webb, Dale; Flatman, Dorothy; Lewycka, Sonia; Rosato, Mikey; Kachale, Fannie; Mwansambo, Charles; Costello, Anthony

    2016-01-01

    Background Maternal, perinatal and neonatal mortality remains high in low-income countries. We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi. Methods We evaluated a rural participatory women’s group community intervention (CI) and a quality improvement intervention at health centres (FI) via a two-by-two factorial cluster randomized controlled trial. Consenting pregnant women were followed-up to 2 months after birth using key informants. Primary outcomes were maternal, perinatal and neonatal mortality. Clusters were health centre catchment areas assigned using stratified computer-generated randomization. Following exclusions, including non-birthing facilities, 61 clusters were analysed: control (17 clusters, 4912 births), FI (15, 5335), CI (15, 5080) and FI + CI (14, 5249). This trial was registered as International Standard Randomised Controlled Trial [ISRCTN18073903]. Outcomes for 14 576 and 20 576 births were recorded during baseline (June 2007–September 2008) and intervention (October 2008–December 2010) periods. Results For control, FI, CI and FI + CI clusters neonatal mortality rates were 34.0, 28.3, 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2, 55.1, 48.0 and 48.4 per 1000 births, during the intervention period. Adjusting for clustering and stratification, the neonatal mortality rate was 22% lower in FI + CI than control clusters (OR = 0.78, 95% CI 0.60–1.01), and the perinatal mortality rate was 16% lower in CI clusters (OR = 0.84, 95% CI 0.72–0.97). We did not observe any intervention effects on maternal mortality. Conclusions Despite implementation problems, a combined community and facility approach using participatory women’s groups and quality improvement at health centres reduced newborn mortality in rural Malawi. PMID:24030269

  10. Effectiveness of single dose rifampicin in preventing leprosy in close contacts of patients with newly diagnosed leprosy: cluster randomised controlled trial

    NARCIS (Netherlands)

    Moet, F. Johannes; Pahan, David; Oskam, Linda; Richardus, Jan H.; van Brakel, Wim H.; Klatser, Paul R.; Saunderson, Paul R.; Smith, W. Cairns S.; Withington, Steve G.; Richardus, Jan Hendrik; Schuring, Ron P.; Faber, Roel; Borsboom, Gerard J. J. M.

    2008-01-01

    OBJECTIVE: To determine the effectiveness of chemoprophylaxis using a single dose of rifampicin to prevent leprosy in close contacts. DESIGN: Single centre, double blind, cluster randomised, placebo controlled trial. SETTING: Leprosy control programme in two districts of northwest Bangladesh with a

  11. MultiComponent Exercise and theRApeutic lifeStyle (CERgAS) intervention to improve physical performance and maintain independent living among urban poor older people--a cluster randomised controlled trial.

    Science.gov (United States)

    Loh, Debbie Ann; Hairi, Noran Naqiah; Choo, Wan Yuen; Mohd Hairi, Farizah; Peramalah, Devi; Kandiben, Shathanapriya; Lee, Pek Ling; Gani, Norlissa; Madzlan, Mohamed Faris; Abd Hamid, Mohd Alif Idham; Akram, Zohaib; Chu, Ai Sean; Bulgiba, Awang; Cumming, Robert G

    2015-02-11

    The ability of older people to function independently is crucial as physical disability and functional limitation have profound impacts on health. Interventions that either delay the onset of frailty or attenuate its severity potentially have cascading benefits for older people, their families and society. This study aims to develop and evaluate the effectiveness of a multiComponent Exercise and theRApeutic lifeStyle (CERgAS) intervention program targeted at improving physical performance and maintaining independent living as compared to general health education among older people in an urban poor setting in Malaysia. This cluster randomised controlled trial will be a 6-week community-based intervention programme for older people aged 60 years and above from urban poor settings. A minimum of 164 eligible participants will be recruited from 8 clusters (low-cost public subsidised flats) and randomised to the intervention and control arm. This study will be underpinned by the Health Belief Model with an emphasis towards self-efficacy. The intervention will comprise multicomponent group exercise sessions, nutrition education, oral care education and on-going support and counselling. These will be complemented with a kit containing practical tips on exercise, nutrition and oral care after each session. Data will be collected over four time points; at baseline, immediately post-intervention, 3-months and 6-months follow-up. Findings from this trial will potentially provide valuable evidence to improve physical function and maintain independence among older people from low-resource settings. This will inform health policies and identify locally acceptable strategies to promote healthy aging, prevent and delay functional decline among older Malaysian adults. ISRCTN22749696.

  12. Physical optics-based diffraction coefficient for a wedge with different face impedances.

    Science.gov (United States)

    Umul, Yusuf Ziya

    2018-03-20

    A new diffraction field expression is introduced with the aid of the modified theory of physical optics for a wedge with different face impedances. First, the scattered geometrical optics fields are determined when both faces of the wedge are illuminated by the incident wave. The geometrical optics waves are then expressed in terms of the sum of two different fields that occur for different impedance wedges. The diffracted fields are determined for the two cases separately, and the total diffracted field is obtained as a sum of these waves. Lastly, the uniform field expressions are obtained, and the resultant fields are numerically compared with the solution of Maliuzhinets.

  13. Age Nutrition Chirugie (ANC) study: impact of a geriatric intervention on the screening and management of undernutrition in elderly patients operated on for colon cancer, a stepped wedge controlled trial.

    Science.gov (United States)

    Dupuis, Marine; Kuczewski, Elisabetta; Villeneuve, Laurent; Bin-Dorel, Sylvie; Haine, Max; Falandry, Claire; Gilbert, Thomas; Passot, Guillaume; Glehen, Olivier; Bonnefoy, Marc

    2017-01-07

    Undernutrition prior to major abdominal surgery is frequent and increases morbidity and mortality, especially in older patients. The management of undernutrition reduces postoperative complications. Nutritional management should be a priority in patient care during the preoperative period. However undernutrition is rarely detected and the guidelines are infrequently followed. Preoperative undernutrition screening should allow a better implementation of the guidelines. The ANC ("Age Nutrition Chirurgie") study is an interventional, comparative, prospective, multicenter, randomized protocol based on the stepped wedge trial design. For the intervention, the surgeon will inform the patient of the establishment of a systematic preoperative geriatric assessment that will allow the preoperative diagnosis of the nutritional status and the implementation of an adjusted nutritional support in accordance with the nutritional guidelines. The primary outcome measure is to determine the impact of the geriatric intervention on the level of perioperative nutritional management, in accordance with the current European guidelines. The implementation of the intervention in the five participating centers will be rolled-out sequentially over six time periods (every six months). Investigators must recommend that all patients aged 70 years or over and who are consulting for a surgery for a colorectal cancer should consider participating in this study. The ANC study is based on an original methodology, the stepped wedge trial design, which is appropriate for evaluating the implementation of a geriatric and nutritional assessment during the perioperative period. We describe the purpose of this geriatric intervention, which is expected to apply the ESPEN and SFNEP recommendations through the establishment of an undernutrition screening and a management program for patients with cancer. This intervention should allow a decrease in patient morbidity and mortality due to undernutrition. This

  14. Wedge geometry, frictional properties and interseismic coupling of the Java megathrust

    Science.gov (United States)

    Koulali, Achraf; McClusky, Simon; Cummins, Phil; Tregoning, Paul

    2018-06-01

    The mechanical interaction between rocks at fault zones is a key element for understanding how earthquakes nucleate and propagate. Therefore, estimating frictional properties along fault planes allows us to infer the degree of elastic strain accumulation throughout the seismic cycle. The Java subduction zone is an active plate boundary where high seismic activity has long been documented. However, very little is known about the seismogenic processes of the megathrust, especially its shallowest portion where onshore geodetic networks are insensitive to recover the pattern of elastic strain. Here, we use the geometry of the offshore accretionary prism to infer frictional properties along the Java subduction zone, using Coulomb critical taper theory. We show that large portions of the inner wedge in the eastern part of the Java subduction megathrust are in a critical state, where the wedge is on the verge of failure everywhere. We identify four clusters with an internal coefficient of friction μint of ∼ 0.8 and hydrostatic pore pressure within the wedge. The average effective coefficient of friction ranges between 0.3 and 0.4, reflecting a strong décollement. Our results also show that the aftershock sequence of the 1994 Mw 7.9 earthquake halted adjacent to a critical segment of the wedge, suggesting that critical taper wedge areas in the eastern Java subduction interface may behave as a permanent barrier to large earthquake rupture. In contrast, in western Java topographic slope and slab dip profiles suggest that the wedge is mechanically stable, i.e deformation is restricted to sliding along the décollement, and likely to coincide with a seismogenic portion of the megathrust. We discuss the seismic hazard implications and highlight the importance of considering the segmentation of the Java subduction zone when assessing the seismic hazard of this region.

  15. Sexually transmitted infection screening uptake and knowledge of sexually transmitted infection symptoms among female sex workers participating in a community randomised trial in Peru.

    Science.gov (United States)

    Kohler, Pamela K; Campos, Pablo E; Garcia, Patricia J; Carcamo, Cesar P; Buendia, Clara; Hughes, James P; Mejia, Carolina; Garnett, Geoff P; Holmes, King K

    2016-04-01

    This study aims to evaluate condom use, sexually transmitted infection (STI) screening, and knowledge of STI symptoms among female sex workers in Peru associated with sex work venues and a community randomised trial of STI control. One component of the Peru PREVEN intervention conducted mobile-team outreach to female sex workers to reduce STIs and increase condom use and access to government clinics for STI screening and evaluation. Prevalence ratios were calculated using multivariate Poisson regression models with robust standard errors, clustering by city. As-treated analyses were conducted to assess outcomes associated with reported exposure to the intervention. Care-seeking was more frequent in intervention communities, but differences were not statistically significant. Female sex workers reporting exposure to the intervention had a significantly higher likelihood of condom use, STI screening at public health clinics, and symptom recognition compared to those not exposed. Compared with street- or bar-based female sex workers, brothel-based female sex workers reported significantly higher rates of condom use with last client, recent screening exams for STIs, and HIV testing. Brothel-based female sex workers also more often reported knowledge of STIs and recognition of STI symptoms in women and in men. Interventions to promote STI detection and prevention among female sex workers in Peru should consider structural or regulatory factors related to sex work venues. © The Author(s) 2015.

  16. APPECT: An Approximate Backbone-Based Clustering Algorithm for Tags

    DEFF Research Database (Denmark)

    Zong, Yu; Xu, Guandong; Jin, Pin

    2011-01-01

    algorithm for Tags (APPECT). The main steps of APPECT are: (1) we execute the K-means algorithm on a tag similarity matrix for M times and collect a set of tag clustering results Z={C1,C2,…,Cm}; (2) we form the approximate backbone of Z by executing a greedy search; (3) we fix the approximate backbone...... as the initial tag clustering result and then assign the rest tags into the corresponding clusters based on the similarity. Experimental results on three real world datasets namely MedWorm, MovieLens and Dmoz demonstrate the effectiveness and the superiority of the proposed method against the traditional...... Agglomerative Clustering on tagging data, which possess the inherent drawbacks, such as the sensitivity of initialization. In this paper, we instead make use of the approximate backbone of tag clustering results to find out better tag clusters. In particular, we propose an APProximate backbonE-based Clustering...

  17. Integrated waste management as a climate change stabilisation wedge for the Maltese islands.

    Science.gov (United States)

    Falzon, Clyde; Fabri, Simon G; Frysinger, Steven

    2013-01-01

    The continuous increase in anthropogenic greenhouse gas emissions occurring since the Industrial Revolution is offering significant ecological challenges to Earth. These emissions are leading to climate changes which bring about extensive damage to communities, ecosystems and resources. The analysis in this article is focussed on the waste sector within the Maltese islands, which is the largest greenhouse gas emitter in the archipelago following the energy and transportation sectors. This work shows how integrated waste management, based on a life cycle assessment methodology, acts as an effective stabilisation wedge strategy for climate change. Ten different scenarios applicable to the Maltese municipal solid waste management sector are analysed. It is shown that the scenario that is most coherent with the stabilisation wedges strategy for the Maltese islands consists of 50% landfilling, 30% mechanical biological treatment and 20% recyclable waste export for recycling. It is calculated that 16.6 Mt less CO2-e gases would be emitted over 50 years by means of this integrated waste management stabilisation wedge when compared to the business-as-usual scenario. These scientific results provide evidence in support of policy development in Malta that is implemented through legislation, economic instruments and other applicable tools.

  18. Observation of the dispersion of wedge waves propagating along cylinder wedge with different truncations by laser ultrasound technique

    Science.gov (United States)

    Jia, Jing; Zhang, Yu; Han, Qingbang; Jing, Xueping

    2017-10-01

    The research focuses on study the influence of truncations on the dispersion of wedge waves propagating along cylinder wedge with different truncations by using the laser ultrasound technique. The wedge waveguide models with different truncations were built by using finite element method (FEM). The dispersion curves were obtained by using 2D Fourier transformation method. Multiple mode wedge waves were observed, which was well agreed with the results estimated from Lagasse's empirical formula. We established cylinder wedge with radius of 3mm, 20° and 60°angle, with 0μm, 5μm, 10μm, 20μm, 30μm, 40μm, and 50μm truncations, respectively. It was found that non-ideal wedge tip caused abnormal dispersion of the mode of cylinder wedge, the modes of 20° cylinder wedge presents the characteristics of guide waves which propagating along hollow cylinder as the truncation increasing. Meanwhile, the modes of 60° cylinder wedge with truncations appears the characteristics of guide waves propagating along hollow cylinder, and its mode are observed clearly. The study can be used to evaluate and detect wedge structure.

  19. Statistical process control and verifying positional accuracy of a cobra motion couch using step-wedge quality assurance tool.

    Science.gov (United States)

    Binny, Diana; Lancaster, Craig M; Trapp, Jamie V; Crowe, Scott B

    2017-09-01

    This study utilizes process control techniques to identify action limits for TomoTherapy couch positioning quality assurance tests. A test was introduced to monitor accuracy of the applied couch offset detection in the TomoTherapy Hi-Art treatment system using the TQA "Step-Wedge Helical" module and MVCT detector. Individual X-charts, process capability (cp), probability (P), and acceptability (cpk) indices were used to monitor a 4-year couch IEC offset data to detect systematic and random errors in the couch positional accuracy for different action levels. Process capability tests were also performed on the retrospective data to define tolerances based on user-specified levels. A second study was carried out whereby physical couch offsets were applied using the TQA module and the MVCT detector was used to detect the observed variations. Random and systematic variations were observed for the SPC-based upper and lower control limits, and investigations were carried out to maintain the ongoing stability of the process for a 4-year and a three-monthly period. Local trend analysis showed mean variations up to ±0.5 mm in the three-monthly analysis period for all IEC offset measurements. Variations were also observed in the detected versus applied offsets using the MVCT detector in the second study largely in the vertical direction, and actions were taken to remediate this error. Based on the results, it was recommended that imaging shifts in each coordinate direction be only applied after assessing the machine for applied versus detected test results using the step helical module. User-specified tolerance levels of at least ±2 mm were recommended for a test frequency of once every 3 months to improve couch positional accuracy. SPC enables detection of systematic variations prior to reaching machine tolerance levels. Couch encoding system recalibrations reduced variations to user-specified levels and a monitoring period of 3 months using SPC facilitated in detecting

  20. Dosimetric parameters of enhanced dynamic wedge for treatment planning and verification

    International Nuclear Information System (INIS)

    Leavitt, Dennis D.; Lee, Wing Lok; Gaffney, David K.

    1996-01-01

    of asymmetric fields having one continuous edge, with the dose delivered within each asymmetric field determined by the segmented treatment table provided by the vendor, and were directly compared with measured profiles. Two different calculation techniques were compared against measured data for symmetric and asymmetric wedge fields. Actual vs. desired wedge angle was determined for the full range of wedge angles and field sizes using the IEC definition for wedge angle. Results: EDW dose distributions for all wedge angles and field sizes are well represented as the sum of open-field and 60 degree dynamic wedge contributions weighted by the technique of ratio-of-tangents. This significantly minimizes the amount of measured or calculated data required within the treatment planning system. Wedge field central axis depth doses differ only marginally from open-field depth doses, with the maximum difference of less than 2% for the 20 cm wide 60 degree wedge field. These small differences are predicted based on dose to the central axis due to photon transmission through the collimating jaws and phantom scatter. The effective wedge factor decreases smoothly with field width and wedge angle up to 20 cm wide fields, then remains relatively 'flat' to the maximum field width. A simple extension of the ratio of tangents formula has been derived which predicts effective wedge factor for any field width and wedge angle and shows excellent agreement to both measured and explicitly calculated values. Two different calculation techniques show excellent agreement with measured EDW profiles for wedges centered on central axis; however, for asymmetric wedges only the explicit summation of segmented asymmetric fields is in good agreement with measured profiles. The idealized wedge angle is not maintained for all field widths and wedge angles; with greatest deviations noted for narrower fields. This is predicted, based on the mechanical technique used to generate the EDW tables

  1. Crowd Analysis by Using Optical Flow and Density Based Clustering

    DEFF Research Database (Denmark)

    Santoro, Francesco; Pedro, Sergio; Tan, Zheng-Hua

    2010-01-01

    In this paper, we present a system to detect and track crowds in a video sequence captured by a camera. In a first step, we compute optical flows by means of pyramidal Lucas-Kanade feature tracking. Afterwards, a density based clustering is used to group similar vectors. In the last step...

  2. a Three-Step Spatial-Temporal Clustering Method for Human Activity Pattern Analysis

    Science.gov (United States)

    Huang, W.; Li, S.; Xu, S.

    2016-06-01

    How people move in cities and what they do in various locations at different times form human activity patterns. Human activity pattern plays a key role in in urban planning, traffic forecasting, public health and safety, emergency response, friend recommendation, and so on. Therefore, scholars from different fields, such as social science, geography, transportation, physics and computer science, have made great efforts in modelling and analysing human activity patterns or human mobility patterns. One of the essential tasks in such studies is to find the locations or places where individuals stay to perform some kind of activities before further activity pattern analysis. In the era of Big Data, the emerging of social media along with wearable devices enables human activity data to be collected more easily and efficiently. Furthermore, the dimension of the accessible human activity data has been extended from two to three (space or space-time) to four dimensions (space, time and semantics). More specifically, not only a location and time that people stay and spend are collected, but also what people "say" for in a location at a time can be obtained. The characteristics of these datasets shed new light on the analysis of human mobility, where some of new methodologies should be accordingly developed to handle them. Traditional methods such as neural networks, statistics and clustering have been applied to study human activity patterns using geosocial media data. Among them, clustering methods have been widely used to analyse spatiotemporal patterns. However, to our best knowledge, few of clustering algorithms are specifically developed for handling the datasets that contain spatial, temporal and semantic aspects all together. In this work, we propose a three-step human activity clustering method based on space, time and semantics to fill this gap. One-year Twitter data, posted in Toronto, Canada, is used to test the clustering-based method. The results show that the

  3. 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

  4. Parenting for Lifelong Health: a pragmatic cluster randomised controlled trial of a non-commercialised parenting programme for adolescents and their families in South Africa

    Science.gov (United States)

    Cluver, Lucie D; Meinck, Franziska; Steinert, Janina I; Shenderovich, Yulia; Doubt, Jenny; Herrero Romero, Rocio; Lombard, Carl J; Redfern, Alice; Ward, Catherine L; Tsoanyane, Sibongile; Nzima, Divane; Sibanda, Nkosiyapha; Wittesaele, Camille; De Stone, Sachin; Boyes, Mark E; Catanho, Ricardo; Lachman, Jamie McLaren; Salah, Nasteha; Nocuza, Mzuvukile; Gardner, Frances

    2018-01-01

    Objective To assess the impact of ‘Parenting for Lifelong Health: Sinovuyo Teen’, a parenting programme for adolescents in low-income and middle-income countries, on abuse and parenting practices. Design Pragmatic cluster randomised controlled trial. Setting 40 villages/urban sites (clusters) in the Eastern Cape province, South Africa. Participants 552 families reporting conflict with their adolescents (aged 10–18). Intervention Intervention clusters (n=20) received a 14-session parent and adolescent programme delivered by trained community members. Control clusters (n=20) received a hygiene and hand-washing promotion programme. Main outcome measures Primary outcomes: abuse and parenting practices at 1 and 5–9 months postintervention. Secondary outcomes: caregiver and adolescent mental health and substance use, adolescent behavioural problems, social support, exposure to community violence and family financial well-being at 5–9 months postintervention. Blinding was not possible. Results At 5–9 months postintervention, the intervention was associated with lower abuse (caregiver report incidence rate ratio (IRR) 0.55 (95% CI 0.40 to 0.75, Pcorporal punishment (caregiver report IRR=0.55 (95% CI 0.37 to 0.83, P=0.004)); improved positive parenting (caregiver report d=0.25 (95% CI 0.03 to 0.47, P=0.024)), involved parenting (caregiver report d=0.86 (95% CI 0.64 to 1.08, Pcorporal punishment IRR=1.05 (95% CI 0.70 to 1.57, P=0.819). Secondary outcomes showed reductions in caregiver corporal punishment endorsement, mental health problems, parenting stress, substance use and increased social support (all caregiver report). Intervention adolescents reported no differences in mental health, behaviour or community violence, but had lower substance use (all adolescent report). Intervention families had improved economic welfare, financial management and more violence avoidance planning (in caregiver and adolescent report). No adverse effects were detected

  5. Big Data Clustering via Community Detection and Hyperbolic Network Embedding in IoT Applications.

    Science.gov (United States)

    Karyotis, Vasileios; Tsitseklis, Konstantinos; Sotiropoulos, Konstantinos; Papavassiliou, Symeon

    2018-04-15

    In this paper, we present a novel data clustering framework for big sensory data produced by IoT applications. Based on a network representation of the relations among multi-dimensional data, data clustering is mapped to node clustering over the produced data graphs. To address the potential very large scale of such datasets/graphs that test the limits of state-of-the-art approaches, we map the problem of data clustering to a community detection one over the corresponding data graphs. Specifically, we propose a novel computational approach for enhancing the traditional Girvan-Newman (GN) community detection algorithm via hyperbolic network embedding. The data dependency graph is embedded in the hyperbolic space via Rigel embedding, allowing more efficient computation of edge-betweenness centrality needed in the GN algorithm. This allows for more efficient clustering of the nodes of the data graph in terms of modularity, without sacrificing considerable accuracy. In order to study the operation of our approach with respect to enhancing GN community detection, we employ various representative types of artificial complex networks, such as scale-free, small-world and random geometric topologies, and frequently-employed benchmark datasets for demonstrating its efficacy in terms of data clustering via community detection. Furthermore, we provide a proof-of-concept evaluation by applying the proposed framework over multi-dimensional datasets obtained from an operational smart-city/building IoT infrastructure provided by the Federated Interoperable Semantic IoT/cloud Testbeds and Applications (FIESTA-IoT) testbed federation. It is shown that the proposed framework can be indeed used for community detection/data clustering and exploited in various other IoT applications, such as performing more energy-efficient smart-city/building sensing.

  6. Maternal and child health nurse screening and care for mothers experiencing domestic violence (MOVE): a cluster randomised trial.

    Science.gov (United States)

    Taft, Angela J; Hooker, Leesa; Humphreys, Cathy; Hegarty, Kelsey; Walter, Ruby; Adams, Catina; Agius, Paul; Small, Rhonda

    2015-06-25

    Mothers are at risk of domestic violence (DV) and its harmful consequences postpartum. There is no evidence to date for sustainability of DV screening in primary care settings. We aimed to test whether a theory-informed, maternal and child health (MCH) nurse-designed model increased and sustained DV screening, disclosure, safety planning and referrals compared with usual care. Cluster randomised controlled trial of 12 month MCH DV screening and care intervention with 24 month follow-up. The study was set in community-based MCH nurse teams (91 centres, 163 nurses) in north-west Melbourne, Australia. Eight eligible teams were recruited. Team randomisation occurred at a public meeting using opaque envelopes. Teams were unable to be blinded. The intervention was informed by Normalisation Process Theory, the nurse-designed good practice model incorporated nurse mentors, strengthened relationships with DV services, nurse safety, a self-completion maternal health screening checklist at three or four month consultations and DV clinical guidelines. Usual care involved government mandated face-to-face DV screening at four weeks postpartum and follow-up as required. Primary outcomes were MCH team screening, disclosure, safety planning and referral rates from routine government data and a postal survey sent to 10,472 women with babies ≤ 12 months in study areas. Secondary outcomes included DV prevalence (Composite Abuse Scale, CAS) and harm measures (postal survey). No significant differences were found in routine screening at four months (IG 2,330/6,381 consultations (36.5 %) versus CG 1,792/7,638 consultations (23.5 %), RR = 1.56 CI 0.96-2.52) but data from maternal health checklists (n = 2,771) at three month IG consultations showed average screening rates of 63.1 %. Two years post-intervention, IG safety planning rates had increased from three (RR 2.95, CI 1.11-7.82) to four times those of CG (RR 4.22 CI 1.64-10.9). Referrals remained low in both intervention groups (IGs

  7. Effect of participatory women's groups and counselling through home visits on children's linear growth in rural eastern India (CARING trial): a cluster-randomised controlled trial.

    Science.gov (United States)

    Nair, Nirmala; Tripathy, Prasanta; Sachdev, H S; Pradhan, Hemanta; Bhattacharyya, Sanghita; Gope, Rajkumar; Gagrai, Sumitra; Rath, Shibanand; Rath, Suchitra; Sinha, Rajesh; Roy, Swati Sarbani; Shewale, Suhas; Singh, Vijay; Srivastava, Aradhana; Costello, Anthony; Copas, Andrew; Skordis-Worrall, Jolene; Haghparast-Bidgoli, Hassan; Saville, Naomi; Prost, Audrey

    2017-10-01

    Around 30% of the world's stunted children live in India. The Government of India has proposed a new cadre of community-based workers to improve nutrition in 200 districts. We aimed to find out the effect of such a worker carrying out home visits and participatory group meetings on children's linear growth. We did a cluster-randomised controlled trial in two adjoining districts of Jharkhand and Odisha, India. 120 clusters (around 1000 people each) were randomly allocated to intervention or control using a lottery. Randomisation took place in July, 2013, and was stratified by district and number of hamlets per cluster (0, 1-2, or ≥3), resulting in six strata. In each intervention cluster, a worker carried out one home visit in the third trimester of pregnancy, monthly visits to children younger than 2 years to support feeding, hygiene, care, and stimulation, as well as monthly women's group meetings to promote individual and community action for nutrition. Participants were pregnant women identified and recruited in the study clusters and their children. We excluded stillbirths and neonatal deaths, infants whose mothers died, those with congenital abnormalities, multiple births, and mother and infant pairs who migrated out of the study area permanently during the trial period. Data collectors visited each woman in pregnancy, within 72 h of her baby's birth, and at 3, 6, 9, 12, and 18 months after birth. The primary outcome was children's length-for-age Z score at 18 months of age. Analyses were by intention to treat. Due to the nature of the intervention, participants and the intervention team were not masked to allocation. Data collectors and the data manager were masked to allocation. The trial is registered as ISCRTN (51505201) and with the Clinical Trials Registry of India (number 2014/06/004664). Between Oct 1, 2013, and Dec 31, 2015, we recruited 5781 pregnant women. 3001 infants were born to pregnant women recruited between Oct 1, 2013, and Feb 10, 2015

  8. Community wide interventions for increasing physical activity.

    Science.gov (United States)

    Baker, Philip R A; Francis, Daniel P; Soares, Jesus; Weightman, Alison L; Foster, Charles

    2015-01-05

    of the newly included, and judged to be at low risk of bias, studies (conducted in Japan, United Kingdom and USA) used randomisation to allocate the intervention to the communities. Three studies used a cluster randomised design and one study used a stepped wedge design. The approach to measuring the primary outcome of physical activity was better in these four studies than in many of the earlier studies. One study obtained objective population representative measurements of physical activity by accelerometers, while the remaining three low-risk studies used validated self-reported measures. The study using accelerometry, conducted in low income, high crime communities of USA, emphasised social marketing, partnership with police and environmental improvements. No change in the seven-day average daily minutes of moderate to vigorous physical activity was observed during the two years of operation. Some program level effect was observed with more people walking in the intervention community, however this result was not evident in the whole community. Similarly, the two studies conducted in the United Kingdom (one in rural villages and the other in urban London; both using communication, partnership and environmental strategies) found no improvement in the mean levels of energy expenditure per person per week, measured from one to four years from baseline. None of the three low risk studies reporting a dichotomous outcome of physical activity found improvements associated with the intervention.Overall, there was a noticeable absence of reporting of benefit in physical activity for community wide interventions in the included studies. However, as a group, the interventions undertaken in China appeared to have the greatest possibility of success with high participation rates reported. Reporting bias was evident with two studies failing to report physical activity measured at follow up. No adverse events were reported.The data pertaining to cost and sustainability of the

  9. Collaborative community based care for people and their families living with schizophrenia in India: protocol for a randomised controlled trial.

    Science.gov (United States)

    Chatterjee, Sudipto; Leese, Morven; Koschorke, Mirja; McCrone, Paul; Naik, Smita; John, Sujit; Dabholkar, Hamid; Goldsmith, Kimberley; Balaji, Madhumitha; Varghese, Mathew; Thara, Rangaswamy; Patel, Vikram; Thornicroft, Graham

    2011-01-13

    There is a large treatment gap with few community services for people with schizophrenia in low income countries largely due to the shortage of specialist mental healthcare human resources. Community based rehabilitation (CBR), involving lay health workers, has been shown to be feasible, acceptable and more effective than routine care for people with schizophrenia in observational studies. The aim of this study is to evaluate whether a lay health worker led, Collaborative Community Based Care (CCBC) intervention, combined with usual Facility Based Care (FBC), is superior to FBC alone in improving outcomes for people with schizophrenia and their caregivers in India. This trial is a multi-site, parallel group randomised controlled trial design in India.The trial will be conducted concurrently at three sites in India where persons with schizophrenia will be screened for eligibility and recruited after providing informed consent. Trial participants will be randomly allocated in a 2:1 ratio to the CCBC+FBC and FBC arms respectively using an allocation sequence pre-prepared through the use of permuted blocks, stratified within site. The structured CCBC intervention will be delivered by trained lay community health workers (CHWs) working together with the treating Psychiatrist. We aim to recruit 282 persons with schizophrenia. The primary outcomes are reduction in severity of symptoms of schizophrenia and disability at 12 months. The study will be conducted according to good ethical practice, data analysis and reporting guidelines. If the additional CCBC intervention delivered by front line CHWs is demonstrated to be effective and cost-effective in comparison to usually available care, this intervention can be scaled up to expand coverage and improve outcomes for persons with schizophrenia and their caregivers in low income countries. The trial is registered with the International Society for the Registration of Clinical Trials and the allocated unique ID number is ISRCTN

  10. Time-based distribution of Staphylococcus saprophyticus pulsed field gel-electrophoresis clusters in community-acquired urinary tract infections

    Directory of Open Access Journals (Sweden)

    Viviane Santos de Sousa

    2013-02-01

    Full Text Available The epidemiology of urinary tract infections (UTI by Staphylococcus saprophyticus has not been fully characterised and strain typing methods have not been validated for this agent. To evaluate whether epidemiological relationships exist between clusters of pulsed field gel-electrophoresis (PFGE genotypes of S. saprophyticus from community-acquired UTI, a cross-sectional surveillance study was conducted in the city of Rio de Janeiro, Brazil. In total, 32 (16% female patients attending two walk-in clinics were culture-positive for S. saprophyticus. Five PFGE clusters were defined and evaluated against epidemiological data. The PFGE clusters were grouped in time, suggesting the existence of community point sources of S. saprophyticus. From these point sources, S. saprophyticus strains may spread among individuals.

  11. Effects of water quality, sanitation, handwashing, and nutritional interventions on child development in rural Kenya (WASH Benefits Kenya): a cluster-randomised controlled trial.

    Science.gov (United States)

    Stewart, Christine P; Kariger, Patricia; Fernald, Lia; Pickering, Amy J; Arnold, Charles D; Arnold, Benjamin F; Hubbard, Alan E; Dentz, Holly N; Lin, Audrie; Meerkerk, Theodora J; Milner, Erin; Swarthout, Jenna; Colford, John M; Null, Clair

    2018-04-01

    Poor nutrition and infectious diseases can prevent children from reaching their developmental potential. We aimed to assess the effects of improvements in water, sanitation, handwashing, and nutrition on early child development in rural Kenya. In this cluster-randomised controlled trial, we enrolled pregnant women in their second or third trimester from three counties (Kakamega, Bungoma, and Vihiga) in Kenya's western region, with an average of 12 households per cluster. Groups of nine geographically adjacent clusters were block-randomised, using a random number generator, into the six intervention groups (including monthly visits to promote target behaviours), a passive control group (no visits), or a double-sized active control group (monthly household visits to measure child mid-upper arm circumference). The six intervention groups were: chlorinated drinking water; improved sanitation; handwashing with soap; combined water, sanitation, and handwashing; improved nutrition through counselling and provision of lipid-based nutrient supplements; and combined water, sanitation, handwashing, and nutrition. Here we report on the prespecified secondary child development outcomes: gross motor milestone achievement assessed with the WHO module at year 1, and communication, gross motor, personal social, and combined scores measured by the Extended Ages and Stages Questionnaire (EASQ) at year 2. Masking of participants was not possible, but data assessors were masked. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01704105. Between Nov 27, 2012, and May 21, 2014, 8246 women residing in 702 clusters were enrolled. No clusters were lost to follow-up, but 2212 households with 2279 children were lost to follow-up by year 2. 5791 (69%) children were measured at year 1 and 6107 (73%) at year 2. At year 1, compared with the active control group, the combined water, sanitation, handwashing, and nutrition group had greater rates of

  12. How effective is high-support community-based step-down housing for women in secure mental health care? A quasi-experimental pilot study.

    Science.gov (United States)

    Barr, W; Brown, A; Quinn, B; McFarlane, J; McCabe, R; Whittington, R

    2013-02-01

    In the past decade UK government policy has been to develop alternative care for women detained in secure psychiatric hospital. This study evaluated the relative benefits of community-based step-down housing. Comparisons were made between female patients in community step-down housing and a control group in secure hospital who were on the waiting list for the houses. For each woman in the sample, a range of assessments was conducted on three separate occasions over a 12-month period. We noted a gradual improvement over time in women in both settings. However, by the final assessment psychological well-being and security needs were significantly better in the community group (P community housing for women in secure psychiatric care. This initiative may provide greater personal freedom and enhanced relational security for the women concerned while also facilitating improvements in their psychological well-being, with no increased risk to the women themselves or to the wider community. © 2012 Blackwell Publishing.

  13. A School Based Cluster Randomised Health Education Intervention Trial for Improving Knowledge and Attitudes Related to Taenia solium Cysticercosis and Taeniasis in Mbulu District, Northern Tanzania

    Science.gov (United States)

    Mwidunda, Sylvester A.; Carabin, Hélène; Matuja, William B. M.; Winkler, Andrea S.; Ngowi, Helena A.

    2015-01-01

    Taenia solium causes significant economic and public health impacts in endemic countries. This study determined effectiveness of a health education intervention at improving school children’s knowledge and attitudes related to T. solium cysticercosis and taeniasis in Tanzania. A cluster randomised controlled health education intervention trial was conducted in 60 schools (30 primary, 30 secondary) in Mbulu district. Baseline data were collected using a structured questionnaire in the 60 schools and group discussions in three other schools. The 60 schools stratified by baseline knowledge were randomised to receive the intervention or serve as control. The health education consisted of an address by a trained teacher, a video show and a leaflet given to each pupil. Two post-intervention re-assessments (immediately and 6 months post-intervention) were conducted in all schools and the third (12 months post-intervention) was conducted in 28 secondary schools. Data were analysed using Bayesian hierarchical log-binomial models for individual knowledge and attitude questions and Bayesian hierarchical linear regression models for scores. The overall score (percentage of correct answers) improved by about 10% in all schools after 6 months, but was slightly lower among secondary schools. Monitoring alone was associated with improvement in scores by about 6%. The intervention was linked to improvements in knowledge regarding taeniasis, porcine cysticercosis, human cysticercosis, epilepsy, the attitude of condemning infected meat but it reduced the attitude of contacting a veterinarian if a pig was found to be infected with cysticercosis. Monitoring alone was linked to an improvement in how best to raise pigs. This study demonstrates the potential value of school children as targets for health messages to control T. solium cysticercosis and taeniasis in endemic areas. Studies are needed to assess effectiveness of message transmission from children to parents and the general

  14. A school based cluster randomised health education intervention trial for improving knowledge and attitudes related to Taenia solium cysticercosis and taeniasis in Mbulu district, northern Tanzania.

    Science.gov (United States)

    Mwidunda, Sylvester A; Carabin, Hélène; Matuja, William B M; Winkler, Andrea S; Ngowi, Helena A

    2015-01-01

    Taenia solium causes significant economic and public health impacts in endemic countries. This study determined effectiveness of a health education intervention at improving school children's knowledge and attitudes related to T. solium cysticercosis and taeniasis in Tanzania. A cluster randomised controlled health education intervention trial was conducted in 60 schools (30 primary, 30 secondary) in Mbulu district. Baseline data were collected using a structured questionnaire in the 60 schools and group discussions in three other schools. The 60 schools stratified by baseline knowledge were randomised to receive the intervention or serve as control. The health education consisted of an address by a trained teacher, a video show and a leaflet given to each pupil. Two post-intervention re-assessments (immediately and 6 months post-intervention) were conducted in all schools and the third (12 months post-intervention) was conducted in 28 secondary schools. Data were analysed using Bayesian hierarchical log-binomial models for individual knowledge and attitude questions and Bayesian hierarchical linear regression models for scores. The overall score (percentage of correct answers) improved by about 10% in all schools after 6 months, but was slightly lower among secondary schools. Monitoring alone was associated with improvement in scores by about 6%. The intervention was linked to improvements in knowledge regarding taeniasis, porcine cysticercosis, human cysticercosis, epilepsy, the attitude of condemning infected meat but it reduced the attitude of contacting a veterinarian if a pig was found to be infected with cysticercosis. Monitoring alone was linked to an improvement in how best to raise pigs. This study demonstrates the potential value of school children as targets for health messages to control T. solium cysticercosis and taeniasis in endemic areas. Studies are needed to assess effectiveness of message transmission from children to parents and the general

  15. A school based cluster randomised health education intervention trial for improving knowledge and attitudes related to Taenia solium cysticercosis and taeniasis in Mbulu district, northern Tanzania.

    Directory of Open Access Journals (Sweden)

    Sylvester A Mwidunda

    Full Text Available Taenia solium causes significant economic and public health impacts in endemic countries. This study determined effectiveness of a health education intervention at improving school children's knowledge and attitudes related to T. solium cysticercosis and taeniasis in Tanzania. A cluster randomised controlled health education intervention trial was conducted in 60 schools (30 primary, 30 secondary in Mbulu district. Baseline data were collected using a structured questionnaire in the 60 schools and group discussions in three other schools. The 60 schools stratified by baseline knowledge were randomised to receive the intervention or serve as control. The health education consisted of an address by a trained teacher, a video show and a leaflet given to each pupil. Two post-intervention re-assessments (immediately and 6 months post-intervention were conducted in all schools and the third (12 months post-intervention was conducted in 28 secondary schools. Data were analysed using Bayesian hierarchical log-binomial models for individual knowledge and attitude questions and Bayesian hierarchical linear regression models for scores. The overall score (percentage of correct answers improved by about 10% in all schools after 6 months, but was slightly lower among secondary schools. Monitoring alone was associated with improvement in scores by about 6%. The intervention was linked to improvements in knowledge regarding taeniasis, porcine cysticercosis, human cysticercosis, epilepsy, the attitude of condemning infected meat but it reduced the attitude of contacting a veterinarian if a pig was found to be infected with cysticercosis. Monitoring alone was linked to an improvement in how best to raise pigs. This study demonstrates the potential value of school children as targets for health messages to control T. solium cysticercosis and taeniasis in endemic areas. Studies are needed to assess effectiveness of message transmission from children to parents and

  16. Protocol for a feasibility cluster randomised controlled trial of a peer-led school-based intervention to increase the physical activity of adolescent girls (PLAN-A).

    Science.gov (United States)

    Sebire, Simon J; Edwards, Mark J; Campbell, Rona; Jago, Russell; Kipping, Ruth; Banfield, Kathryn; Tomkinson, Keeley; Garfield, Kirsty; Lyons, Ronan A; Simon, Joanne; Blair, Peter S; Hollingworth, William

    2016-01-01

    Physical activity levels are low amongst adolescent girls, and this population faces specific barriers to being active. Peer influences on health behaviours are important in adolescence and peer-led interventions might hold promise to change behaviour. This paper describes the protocol for a feasibility cluster randomised controlled trial of Peer-Led physical Activity iNtervention for Adolescent girls (PLAN-A), a peer-led intervention aimed at increasing adolescent girls' physical activity levels. A two-arm cluster randomised feasibility trial will be conducted in six secondary schools (intervention n  = 4; control n  = 2) with year 8 (12-13 years old) girls. The intervention will operate at a year group level and consist of year 8 girls nominating influential peers within their year group to become peer-supporters. Approximately 15 % of the cohort will receive 3 days of training about physical activity and interpersonal communication skills. Peer-supporters will then informally diffuse messages about physical activity amongst their friends for 10 weeks. Data will be collected at baseline (time 0 (T0)), immediately after the intervention (time 1 (T1)) and 12 months after baseline measures (time 2 (T2)). In this feasibility trial, the primary interest is in the recruitment of schools and participants (both year 8 girls and peer-supporters), delivery and receipt of the intervention, data provision rates and identifying the cost categories for future economic analysis. Physical activity will be assessed using 7-day accelerometry, with the likely primary outcome in a fully-powered trial being daily minutes of moderate-to-vigorous physical activity. Participants will also complete psychosocial questionnaires at each time point: assessing motivation, self-esteem and peer physical activity norms. Data analysis will be largely descriptive and focus on recruitment, attendance and data provision rates. The findings will inform the sample size required for a

  17. An exploratory cluster randomised trial of a university halls of residence based social norms marketing campaign to reduce alcohol consumption among 1st year students.

    Science.gov (United States)

    Moore, Graham F; Williams, Annie; Moore, Laurence; Murphy, Simon

    2013-04-18

    This exploratory trial examines the feasibility of implementing a social norms marketing campaign to reduce student drinking in universities in Wales, and evaluating it using cluster randomised trial methodology. Fifty residence halls in 4 universities in Wales were randomly assigned to intervention or control arms. Web and paper surveys were distributed to students within these halls (n = 3800), assessing exposure/contamination, recall of and evaluative responses to intervention messages, perceived drinking norms and personal drinking behaviour. Measures included the Drinking Norms Rating Form, the Daily Drinking Questionnaire and AUDIT-C. A response rate of 15% (n = 554) was achieved, varying substantially between sites. Intervention posters were seen by 80% and 43% of students in intervention and control halls respectively, with most remaining materials seen by a minority in both groups. Intervention messages were rated as credible and relevant by little more than half of students, though fewer felt they would influence their behaviour, with lighter drinkers more likely to perceive messages as credible. No differences in perceived norms were observed between intervention and control groups. Students reporting having seen intervention materials reported lower descriptive and injunctive norms than those who did not. Attention is needed to enhancing exposure, credibility and perceived relevance of intervention messages, particularly among heavier drinkers, before definitive evaluation can be recommended. A definitive evaluation would need to consider how it would achieve sufficient response rates, whilst hall-level cluster randomisation appears subject to a significant degree of contamination. ISRCTN: ISRCTN48556384.

  18. The effectiveness of an aged care specific leadership and management program on workforce, work environment, and care quality outcomes: design of a cluster randomised controlled trial.

    Science.gov (United States)

    Jeon, Yun-Hee; Simpson, Judy M; Chenoweth, Lynn; Cunich, Michelle; Kendig, Hal

    2013-10-25

    A plethora of observational evidence exists concerning the impact of management and leadership on workforce, work environment, and care quality. Yet, no randomised controlled trial has been conducted to test the effectiveness of leadership and management interventions in aged care. An innovative aged care clinical leadership program (Clinical Leadership in Aged Care--CLiAC) was developed to improve managers' leadership capacities to support the delivery of quality care in Australia. This paper describes the study design of the cluster randomised controlled trial testing the effectiveness of the program. Twenty-four residential and community aged care sites were recruited as managers at each site agreed in writing to participate in the study and ensure that leaders allocated to the control arm would not be offered the intervention program. Sites undergoing major managerial or structural changes were excluded. The 24 sites were randomly allocated to receive the CLiAC program (intervention) or usual care (control), stratified by type (residential vs. community, six each for each arm). Treatment allocation was masked to assessors and staff of all participating sites. The objective is to establish the effectiveness of the CLiAC program in improving work environment, workforce retention, as well as care safety and quality, when compared to usual care. The primary outcomes are measures of work environment, care quality and safety, and staff turnover rates. Secondary outcomes include manager leadership capacity, staff absenteeism, intention to leave, stress levels, and job satisfaction. Differences between intervention and control groups will be analysed by researchers blinded to treatment allocation using linear regression of individual results adjusted for stratification and clustering by site (primary analysis), and additionally for baseline values and potential confounders (secondary analysis). Outcomes measured at the site level will be compared by cluster

  19. The effectiveness of an aged care specific leadership and management program on workforce, work environment, and care quality outcomes: design of a cluster randomised controlled trial

    Science.gov (United States)

    2013-01-01

    Background A plethora of observational evidence exists concerning the impact of management and leadership on workforce, work environment, and care quality. Yet, no randomised controlled trial has been conducted to test the effectiveness of leadership and management interventions in aged care. An innovative aged care clinical leadership program (Clinical Leadership in Aged Care − CLiAC) was developed to improve managers’ leadership capacities to support the delivery of quality care in Australia. This paper describes the study design of the cluster randomised controlled trial testing the effectiveness of the program. Methods Twenty-four residential and community aged care sites were recruited as managers at each site agreed in writing to participate in the study and ensure that leaders allocated to the control arm would not be offered the intervention program. Sites undergoing major managerial or structural changes were excluded. The 24 sites were randomly allocated to receive the CLiAC program (intervention) or usual care (control), stratified by type (residential vs. community, six each for each arm). Treatment allocation was masked to assessors and staff of all participating sites. The objective is to establish the effectiveness of the CLiAC program in improving work environment, workforce retention, as well as care safety and quality, when compared to usual care. The primary outcomes are measures of work environment, care quality and safety, and staff turnover rates. Secondary outcomes include manager leadership capacity, staff absenteeism, intention to leave, stress levels, and job satisfaction. Differences between intervention and control groups will be analysed by researchers blinded to treatment allocation using linear regression of individual results adjusted for stratification and clustering by site (primary analysis), and additionally for baseline values and potential confounders (secondary analysis). Outcomes measured at the site level will be

  20. Overlapping communities from dense disjoint and high total degree clusters

    Science.gov (United States)

    Zhang, Hongli; Gao, Yang; Zhang, Yue

    2018-04-01

    Community plays an important role in the field of sociology, biology and especially in domains of computer science, where systems are often represented as networks. And community detection is of great importance in the domains. A community is a dense subgraph of the whole graph with more links between its members than between its members to the outside nodes, and nodes in the same community probably share common properties or play similar roles in the graph. Communities overlap when nodes in a graph belong to multiple communities. A vast variety of overlapping community detection methods have been proposed in the literature, and the local expansion method is one of the most successful techniques dealing with large networks. The paper presents a density-based seeding method, in which dense disjoint local clusters are searched and selected as seeds. The proposed method selects a seed by the total degree and density of local clusters utilizing merely local structures of the network. Furthermore, this paper proposes a novel community refining phase via minimizing the conductance of each community, through which the quality of identified communities is largely improved in linear time. Experimental results in synthetic networks show that the proposed seeding method outperforms other seeding methods in the state of the art and the proposed refining method largely enhances the quality of the identified communities. Experimental results in real graphs with ground-truth communities show that the proposed approach outperforms other state of the art overlapping community detection algorithms, in particular, it is more than two orders of magnitude faster than the existing global algorithms with higher quality, and it obtains much more accurate community structure than the current local algorithms without any priori information.

  1. Steps toward improving diet and exercise for cancer survivors (STRIDE): a quasi-randomised controlled trial protocol.

    Science.gov (United States)

    Frensham, Lauren J; Zarnowiecki, Dorota M; Parfitt, Gaynor; Stanley, Rebecca M; Dollman, James

    2014-06-13

    Cancer survivorship rates have increased in developed countries largely due to population ageing and improvements in cancer care. Survivorship is a neglected phase of cancer treatment and is often associated with adverse physical and psychological effects. There is a need for broadly accessible, non-pharmacological measures that may prolong disease-free survival, reduce or alleviate co-morbidities and enhance quality of life. The aim of the Steps TowaRd Improving Diet and Exercise (STRIDE) study is to evaluate the effectiveness of an online-delivered physical activity intervention for increasing walking in cancer survivors living in metropolitan and rural areas of South Australia. This is a quasi-randomised controlled trial. The intervention period is 12-weeks with 3-month follow-up. The trial will be conducted at a university setting and community health services in South Australia. Participants will be insufficiently active and aged 18 years or older. Participants will be randomly assigned to either the intervention or control group. All participants will receive a pedometer but only the intervention group will have access to the STRIDE website where they will report steps, affect and ratings of perceived exertion (RPE) during exercise daily. Researchers will use these variables to individualise weekly step goals to increase walking.The primary outcome measure is steps per day. The secondary outcomes are a) health measures (anthropometric and physiological), b) dietary habits (consumption of core foods and non-core foods) and c) quality of life (QOL) including physical, psychological and social wellbeing. Measures will be collected at baseline, post-intervention and 3-month follow-up. This protocol describes the implementation of a trial using an online resource to assist cancer survivors to become more physically active. It is an innovative tool that uses ratings of perceived exertion and daily affect to create individualised step goals for cancer survivors. The

  2. Delivering prevention for alcohol and cannabis using the Internet: a cluster randomised controlled trial.

    Science.gov (United States)

    Newton, Nicola C; Andrews, Gavin; Teesson, Maree; Vogl, Laura E

    2009-06-01

    To establish the efficacy of an internet based prevention program to reduce alcohol and cannabis use in adolescents. A cluster randomised controlled trial was conducted with 764 13-year olds from ten Australian secondary schools in 2007-2008. Half the schools were randomly allocated to the computerised prevention program (n=397), and half to their usual health classes (n=367). The Climate Schools: Alcohol and Cannabis prevention course is facilitated by the internet and consists of novel, evidence-based, curriculum consistent lessons aimed at reducing alcohol and cannabis use. Participants were assessed at baseline, immediately post, and at six months following the intervention. Compared to the control group, students in the intervention group showed significant improvements in alcohol and cannabis knowledge at the end of the course and the six month follow-up. In addition, the intervention group showed a reduction in average weekly alcohol consumption and frequency of cannabis use at the six month follow-up. No differences between groups were found on alcohol expectancies, cannabis attitudes, or alcohol and cannabis related harms. The course is acceptable, scalable and fidelity is assured. It increased knowledge regarding alcohol and cannabis, and decreased use of these drugs.

  3. Three-dimensional wedge filling in ordered and disordered systems

    International Nuclear Information System (INIS)

    Greenall, M J; Parry, A O; Romero-Enrique, J M

    2004-01-01

    We investigate interfacial structural and fluctuation effects occurring at continuous filling transitions in 3D wedge geometries. We show that fluctuation-induced wedge covariance relations that have been reported recently for 2D filling and wetting have mean-field or classical analogues that apply to higher-dimensional systems. Classical wedge covariance emerges from analysis of filling in shallow wedges based on a simple interfacial Hamiltonian model and is supported by detailed numerical investigations of filling within a more microscopic Landau-like density functional theory. Evidence is presented that classical wedge covariance is also obeyed for filling in more acute wedges in the asymptotic critical regime. For sufficiently short-ranged forces mean-field predictions for the filling critical exponents and covariance are destroyed by pseudo-one-dimensional interfacial fluctuations. We argue that in this filling fluctuation regime the critical exponents describing the divergence of length scales are related to values of the interfacial wandering exponent ζ(d) defined for planar interfaces in (bulk) two-dimensional (d = 2) and three-dimensional (d = 3) systems. For the interfacial height l w ∼ θ-α) -β w , with θ the contact angle and α the wedge tilt angle, we find β w = ζ(2)/2(1-ζ(3)). For pure systems (thermal disorder) we recover the known result β w = 1/4 predicted by interfacial Hamiltonian studies whilst for random-bond disorder we predict the universal critical exponent β ∼ even in the presence of dispersion forces. We revisit the transfer matrix theory of three-dimensional filling based on an effective interfacial Hamiltonian model and discuss the interplay between breather, tilt and torsional interfacial fluctuations. We show that the coupling of the modes allows the problem to be mapped onto a quantum mechanical problem as conjectured by previous authors. The form of the interfacial height probability distribution function predicted by

  4. Big Data Clustering via Community Detection and Hyperbolic Network Embedding in IoT Applications

    Directory of Open Access Journals (Sweden)

    Vasileios Karyotis

    2018-04-01

    Full Text Available In this paper, we present a novel data clustering framework for big sensory data produced by IoT applications. Based on a network representation of the relations among multi-dimensional data, data clustering is mapped to node clustering over the produced data graphs. To address the potential very large scale of such datasets/graphs that test the limits of state-of-the-art approaches, we map the problem of data clustering to a community detection one over the corresponding data graphs. Specifically, we propose a novel computational approach for enhancing the traditional Girvan–Newman (GN community detection algorithm via hyperbolic network embedding. The data dependency graph is embedded in the hyperbolic space via Rigel embedding, allowing more efficient computation of edge-betweenness centrality needed in the GN algorithm. This allows for more efficient clustering of the nodes of the data graph in terms of modularity, without sacrificing considerable accuracy. In order to study the operation of our approach with respect to enhancing GN community detection, we employ various representative types of artificial complex networks, such as scale-free, small-world and random geometric topologies, and frequently-employed benchmark datasets for demonstrating its efficacy in terms of data clustering via community detection. Furthermore, we provide a proof-of-concept evaluation by applying the proposed framework over multi-dimensional datasets obtained from an operational smart-city/building IoT infrastructure provided by the Federated Interoperable Semantic IoT/cloud Testbeds and Applications (FIESTA-IoT testbed federation. It is shown that the proposed framework can be indeed used for community detection/data clustering and exploited in various other IoT applications, such as performing more energy-efficient smart-city/building sensing.

  5. Comparing virtual with physical wedge for the transmission factors

    International Nuclear Information System (INIS)

    Lin Kuei-Hua; Lin Jao-Perng; Chu Tieh-Chi; Liu Mu-Tai

    2000-01-01

    This paper investigates the discrepancies between virtual wedge and physical wedge at the standard wedge angles of 15, 30, 45, and 60 degrees. The dose distributions for virtual wedge and physics wedge were measured by using a commercial multichamber detector array. The transmission factors of each virtual wedge and physical wedge were measured for Siemens PRIMUS 3008 linear accelerator by single ion chamber. These factors were used to set-up the clinical treatment data tables for clinical dosimetry for virtual wedge utilization. The Wellhoefer IC15, 0.13cc chamber was installed on the chamber frame of Wellhoefer water phantom (48x48x40 cm 3 ). The surface of water was at 100 cm SSD. The output factor in water were measured on the central axis of each field at 5 cm depth for 6MV or 10 cm depth for 15MV X-ray on virtual wedge and physical wedge. Comparing virtual wedge with physical wedge for transmission factor as field size range from 4x4 to 25x25 cm 2 . We have measured the dose distributions using the chamber array for 25x25 cm 2 virtual wedge fields and physical wedge fields at wedge angles of 15deg to 60deg. The dose profiles at various depths were also measured using the chamber array. The transmission factors of each physical wedge were slowly increased as field sizes increase, and had different value for each wedge angle. The transmission factors of each virtual wedge were almost constant value as 1.0 for each wedge angle. The results show that the dose profiles including the penumbra dose measured by the chamber array for virtual wedge agree with those measured for the physical wedge. For transmission factors of virtual wedge were constant value as 1.0 for each angles, namely output without wedge is almost equal to output with wedge on the central axis. Virtual wedge has practical and dosimetric advantages over physical wedge. (author)

  6. Enhanced maternal and child health nurse care for women experiencing intimate partner/family violence: protocol for MOVE, a cluster randomised trial of screening and referral in primary health care.

    Science.gov (United States)

    Taft, Angela J; Small, Rhonda; Humphreys, Cathy; Hegarty, Kelsey; Walter, Ruby; Adams, Catina; Agius, Paul

    2012-09-20

    Intimate partner violence (IPV) can result in significant harm to women and families and is especially prevalent when women are pregnant or recent mothers. Maternal and child health nurses (MCHN) in Victoria, Australia are community-based nurse/midwives who see over 95% of all mothers with newborns. MCHN are in an ideal position to identify and support women experiencing IPV, or refer them to specialist family violence services. Evidence for IPV screening in primary health care is inconclusive to date. The Victorian government recently required nurses to screen all mothers when babies are four weeks old, offering an opportunity to examine the effectiveness of MCHN IPV screening practices. This protocol describes the development and design of MOVE, a study to examine IPV screening effectiveness and the sustainability of screening practice. MOVE is a cluster randomised trial of a good practice model of MCHN IPV screening involving eight maternal and child health nurse teams in Melbourne, Victoria. Normalisation Process Theory (NPT) was incorporated into the design, implementation and evaluation of the MOVE trial to enhance and evaluate sustainability. Using NPT, the development stage combined participatory action research with intervention nurse teams and a systematic review of nurse IPV studies to develop an intervention model incorporating consensus guidelines, clinical pathway and strategies for individual nurses, their teams and family violence services. Following twelve months' implementation, primary outcomes assessed include IPV inquiry, IPV disclosure by women and referral using data from MCHN routine data collection and a survey to all women giving birth in the previous eight months. IPV will be measured using the Composite Abuse Scale. Process and impact evaluation data (online surveys and key stakeholders interviews) will highlight NPT concepts to enhance sustainability of IPV identification and referral. Data will be collected again in two years. MOVE

  7. Early intervention for adolescents with Patellofemoral Pain Syndrome - a pragmatic cluster randomised controlled trial

    Science.gov (United States)

    2012-01-01

    Background Self-reported knee pain is highly prevalent among adolescents. As much as 50% of the non-specific knee pain may be attributed to Patellofemoral Pain Syndrome (PFPS). In the short term, exercise therapy appears to have a better effect than patient education consisting of written information and general advice on exercise or compared with placebo treatment. But the long-term effect of exercise therapy compared with patient education is conflicting. The purpose of this study is to examine the short- and long-term effectiveness of patient education compared with patient education and multimodal physiotherapy applied at a very early stage of the condition among adolescents. Methods/Design This study is a single blind pragmatic cluster randomised controlled trial. Four upper secondary schools have been invited to participate in the study (approximately 2500 students, aged 15-19 years). Students are asked to answer an online questionnaire regarding musculoskeletal pain. The students who report knee pain are contacted by telephone and offered a clinical examination by a rheumatologist. Subjects who fit the inclusion criteria and are diagnosed with PFPS are invited to participate in the study. A minimum of 102 students with PFPS are then cluster-randomised into two intervention groups based on which school they attend. Both intervention groups receive written information and education. In addition to patient education, one group receives multimodal physiotherapy consisting primarily of neuromuscular training of the muscles around the foot, knee and hip and home exercises. The students with PFPS fill out self-reported questionnaires at baseline, 3, 6, 12 and 24 months after inclusion in the study. The primary outcome measure is perception of recovery measured on a 7-point Likert scale ranging from "completely recovered" to "worse than ever" at 12 months. Discussion This study is designed to investigate the effectiveness of patient education compared with patient

  8. A cluster-randomised, controlled trial to assess the impact of a workplace osteoporosis prevention intervention on the dietary and physical activity behaviours of working women: study protocol.

    Science.gov (United States)

    Tan, Ai May; Lamontagne, Anthony D; Sarmugam, Rani; Howard, Peter

    2013-04-29

    Osteoporosis is a debilitating disease and its risk can be reduced through adequate calcium consumption and physical activity. This protocol paper describes a workplace-based intervention targeting behaviour change in premenopausal women working in sedentary occupations. A cluster-randomised design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the clusters and units of randomisation and intervention. Sample size calculations incorporated the cluster design. Final number of clusters was determined to be 16, based on a cluster size of 20 and calcium intake parameters (effect size 250 mg, ICC 0.5 and standard deviation 290 mg) as it required the highest number of clusters.Sixteen workplaces were recruited from a pool of 97 workplaces and randomly assigned to intervention and control arms (eight in each). Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organisation wide educational activities. Workplaces in the control/standard care arm received print resources. Intervention workshops were guided by self-efficacy theory and included participatory activities such as goal setting, problem solving, local food sampling, exercise trials, group discussion and behaviour feedback.Outcomes measures were calcium intake (milligrams/day) and physical activity level (duration: minutes/week), measured at baseline, four weeks and six months post intervention. This study addresses the current lack of evidence for behaviour change interventions focussing on osteoporosis prevention. It addresses missed opportunities of using workplaces as a platform to target high-risk individuals with sedentary occupations. The intervention was designed to modify behaviour levels to bring about risk reduction. It is the first to address dietary and physical activity components each with unique intervention strategies in the context of osteoporosis

  9. In Situ Field Sequencing and Life Detection in Remote (79°26′N Canadian High Arctic Permafrost Ice Wedge Microbial Communities

    Directory of Open Access Journals (Sweden)

    J. Goordial

    2017-12-01

    Full Text Available Significant progress is being made in the development of the next generation of low cost life detection instrumentation with much smaller size, mass and energy requirements. Here, we describe in situ life detection and sequencing in the field in soils over laying ice wedges in polygonal permafrost terrain on Axel Heiberg Island, located in the Canadian high Arctic (79°26′N, an analog to the polygonal permafrost terrain observed on Mars. The life detection methods used here include (1 the cryo-iPlate for culturing microorganisms using diffusion of in situ nutrients into semi-solid media (2 a Microbial Activity Microassay (MAM plate (BIOLOG Ecoplate for detecting viable extant microorganisms through a colourimetric assay, and (3 the Oxford Nanopore MinION for nucleic acid detection and sequencing of environmental samples and the products of MAM plate and cryo-iPlate. We obtained 39 microbial isolates using the cryo-iPlate, which included several putatively novel strains based on the 16S rRNA gene, including a Pedobacter sp. (96% closest similarity in GenBank which we partially genome sequenced using the MinION. The MAM plate successfully identified an active community capable of L-serine metabolism, which was used for metagenomic sequencing with the MinION to identify the active and enriched community. A metagenome on environmental ice wedge soil samples was completed, with base calling and uplink/downlink carried out via satellite internet. Validation of MinION sequencing using the Illumina MiSeq platform was consistent with the results obtained with the MinION. The instrumentation and technology utilized here is pre-existing, low cost, low mass, low volume, and offers the prospect of equipping micro-rovers and micro-penetrators with aggressive astrobiological capabilities. Since potentially habitable astrobiology targets have been identified (RSLs on Mars, near subsurface water ice on Mars, the plumes and oceans of Europa and Enceladus

  10. Community detection in complex networks using proximate support vector clustering

    Science.gov (United States)

    Wang, Feifan; Zhang, Baihai; Chai, Senchun; Xia, Yuanqing

    2018-03-01

    Community structure, one of the most attention attracting properties in complex networks, has been a cornerstone in advances of various scientific branches. A number of tools have been involved in recent studies concentrating on the community detection algorithms. In this paper, we propose a support vector clustering method based on a proximity graph, owing to which the introduced algorithm surpasses the traditional support vector approach both in accuracy and complexity. Results of extensive experiments undertaken on computer generated networks and real world data sets illustrate competent performances in comparison with the other counterparts.

  11. Contralateral breast dose reduction using a virtual wedge

    International Nuclear Information System (INIS)

    Yeo, In Hwan; Kim, Dae Yong; Kim, Tae Hyun; Shin, Kyung Hwan; Chie, Eui Kyu; Park, Won; Lim, Do Hoon; Huh, Seung Jae; Ahn, Yong Chan

    2005-01-01

    To evaluate the contralateral breast dose using a virtual wedge compared with that using a physical wedge and an open beam in a Siemens linear accelerator. The contralateral breast dose was measured using diodes placed on a humanoid phantom. Diodes were placed at 5.5 cm (position 1), 9.5 cm (position 2), and 14 cm (position 3) along the medial-lateral line from the medial edge of the treatment field. A 6-MV photon beam was used with tangential irradiation technique at 50 and 230 degrees of gantry angle. Asymmetrically collimated 17 x 10 cm field was used. For the first set of experiment, four treatment set-ups were used, which were an open medial beam with a 30-degree wedged lateral beam (physical and virtual wedges, respectively) and a 15-degree wedge medial beam with a 15-degree wedged lateral beam (physical and virtual wedges, respectively). The second set of experiment consists of setting with medial beam without wedge, a 15-degree wedge, and a 60-degree wedge (physical and virtual wedges, respectively). Identical monitor units were delivered. Each set of experiment was repeated for three times. In the first set of experiment, the contralateral breast dose was the highest at the position 1 and decreased in order of the position 2 and 3. The contralateral breast dose was reduced with open beam on the medial side (2.70± 1.46%) compared to medial beam with a wedge (both physical and virtual) (3.25 ± 1.59%). The differences were larger with a physical wedge (0.99 ± 0.18%) than a virtual wedge (0.10 ± 0.01%) at all positions. The use of a virtual wedge reduced the contralateral breast dose by 0.12% to 1.20% of the prescribed dose compared to a physical wedge with same technique. In the second experiment, the contralateral breast dose decreased in order of the open beam, the virtual wedge, and the physical wedge at the position 1, and it decreased in order of a physical wedge, an open beam, and a virtual wedge at the position 2 and 3. The virtual wedge equipped

  12. Phase Space Exchange in Thick Wedge Absorbers

    Energy Technology Data Exchange (ETDEWEB)

    Neuffer, David [Fermi National Accelerator Lab. (FNAL), Batavia, IL (United States)

    2017-01-01

    The problem of phase space exchange in wedge absorbers with ionization cooling is discussed. The wedge absorber exchanges transverse and longitudinal phase space by introducing a position-dependent energy loss. In this paper we note that the wedges used with ionization cooling are relatively thick, so that single wedges cause relatively large changes in beam phase space. Calculation methods adapted to such “thick wedge” cases are presented, and beam phase-space transformations through such wedges are discussed.

  13. Safety of Seasonal Malaria Chemoprevention (SMC with Sulfadoxine-Pyrimethamine plus Amodiaquine when Delivered to Children under 10 Years of Age by District Health Services in Senegal: Results from a Stepped-Wedge Cluster Randomized Trial.

    Directory of Open Access Journals (Sweden)

    J L NDiaye

    Full Text Available It is recommended that children aged 3 months to five years of age living in areas of seasonal transmission in the sub-Sahel should receive Seasonal Malaria Chemoprevention (SMC with sulfadoxine-pyrimethamine plus amodiaquine (SPAQ during the malaria transmission season. The purpose of this study was to evaluate the safety of SMC with SPAQ in children when delivered by community health workers in three districts in Senegal where SMC was introduced over three years, in children from 3 months of age to five years of age in the first year, then in children up to 10 years of age.A surveillance system was established to record all deaths and all malaria cases diagnosed at health facilities and a pharmacovigilance system was established to detect adverse drug reactions. Health posts were randomized to introduce SMC in a stepped wedge design. SMC with SPAQ was administered once per month from September to November, by nine health-posts in 2008, by 27 in 2009 and by 45 in 2010.After three years, 780,000 documented courses of SMC had been administered. High coverage was achieved. No serious adverse events attributable to the intervention were detected, despite a high level of surveillance.SMC is being implemented in countries of the sub-Sahel for children under 5 years of age, but in some areas the age distribution of cases of malaria may justify extending this age limit, as has been done in Senegal. Our results show that SMC is well tolerated in children under five and in older children. However, pharmacovigilance should be maintained where SMC is implemented and provision for strengthening national pharmacovigilance systems should be included in plans for SMC implementation.ClinicalTrials.gov NCT 00712374.

  14. Cluster randomised controlled trial of 'whole school' child maltreatment prevention programme in primary schools in Northern Ireland: study protocol for Keeping Safe.

    Science.gov (United States)

    McElearney, Aisling; Brennan-Wilson, Aoibheann; Murphy, Christina; Stephenson, Phyllis; Bunting, Brendan

    2018-05-03

    Child maltreatment has a pervasive, detrimental impact on children's wellbeing. Despite a growing focus on prevention through school based education, few programmes adopt a whole- school approach, are multi-component, seek to address all forms of maltreatment, or indeed have been robustly evaluated. This paper describes a cluster randomised controlled trial designed to evaluate a school based child maltreatment prevention programme: 'Keeping Safe' in primary schools in Northern Ireland. The intervention has been designed by a non-profit agency. Programme resources include 63 lessons taught incrementally to children between four and 11 years old, and is premised on three core themes: healthy relationships, my body, and being safe. There are programme resources to engage parents and to build the capacity and skills of school staff. A cluster Randomised Controlled Trial (RCT) will be conducted with children in 80 schools over a two-year period. The unit of randomisation is the school. Schools will be allocated to intervention or wait-list control groups using a computer-generated list. Data will be collected at three time points: baseline, end of year one, and end of year two of programme implementation. Primary outcomes will include: children's understanding of key programme concepts, self-efficacy to keep safe in situations of maltreatment, anxiety arising from programme participation, and disclosure of maltreatment. Secondary outcomes include teachers' comfort and confidence in teaching the programme and parents' confidence in talking to their children about programme concepts. This RCT will address gaps in current practice and evidence regarding school based child maltreatment prevention programmes. This includes the use of a whole- school approach and multi-component programme that addresses all maltreatment concepts, a two-year period of programme implementation, and the tracking of outcomes for children, parents, and teachers. Methodologically, it will extend

  15. Cluster randomised controlled trial of a consumer behaviour intervention to improve healthy food purchases from online canteens: study protocol.

    Science.gov (United States)

    Delaney, Tessa; Wyse, Rebecca; Yoong, Sze Lin; Sutherland, Rachel; Wiggers, John; Ball, Kylie; Campbell, Karen; Rissel, Chris; Wolfenden, Luke

    2017-04-17

    School canteens represent an opportune setting in which to deliver public health nutrition strategies given their wide reach, and frequent use by children. Online school canteen ordering systems, where students order and pay for their lunch online, provide an avenue to improve healthy canteen purchases through the application of consumer behaviour strategies that impact on purchasing decisions. The aim of this study is to assess the efficacy of a consumer behaviour intervention implemented in an online school canteen ordering system in reducing the kilojoule, saturated fat, sugar and sodium content of primary student lunch orders. The study will employ a cluster randomised controlled trial design. Approximately 1040 students (aged 5-12 years) from 10 primary schools in New South Wales, Australia, currently using an online canteen ordering system will be invited to participate. Schools will be randomised in a 1:1 ratio to receive either the intervention (enhanced system) or control (standard online ordering only). The intervention will include evidence-based strategies shown to influence healthy food purchasing (strategies targeting availability, menu labelling, placement and prompting). The primary outcomes of the trial will be the mean content per student online lunch order of (1) energy (kJ), (2) saturated fat (g), (3) sugar (g) and (4) sodium (mg). The impact of the intervention will be determined by between-group assessment of the nutritional content of lunch purchases over a 2-month period postintervention initiation. The study was approved by the Hunter New England Human Research Ethics Committee, University of Newcastle Human Research Ethics Committee and New South Wales Department of Education and School Communities. Study findings will be disseminated widely through peer-reviewed publications and relevant presentations in international conferences and to stakeholders. ACTRN12616000499482. Published by the BMJ Publishing Group Limited. For permission to

  16. A cluster-randomised quality improvement study to improve two inpatient stroke quality indicators.

    Science.gov (United States)

    Williams, Linda; Daggett, Virginia; Slaven, James E; Yu, Zhangsheng; Sager, Danielle; Myers, Jennifer; Plue, Laurie; Woodward-Hagg, Heather; Damush, Teresa M

    2016-04-01

    Quality indicator collection and feedback improves stroke care. We sought to determine whether quality improvement training plus indicator feedback was more effective than indicator feedback alone in improving inpatient stroke indicators. We conducted a cluster-randomised quality improvement trial, randomising hospitals to quality improvement training plus indicator feedback versus indicator feedback alone to improve deep vein thrombosis (DVT) prophylaxis and dysphagia screening. Intervention sites received collaborative-based quality improvement training, external facilitation and indicator feedback. Control sites received only indicator feedback. We compared indicators pre-implementation (pre-I) to active implementation (active-I) and post-implementation (post-I) periods. We constructed mixed-effect logistic models of the two indicators with a random intercept for hospital effect, adjusting for patient, time, intervention and hospital variables. Patients at intervention sites (1147 admissions), had similar race, gender and National Institutes of Health Stroke Scale scores to control sites (1017 admissions). DVT prophylaxis improved more in intervention sites during active-I period (ratio of ORs 4.90, pimproved similarly in both groups during active-I, but control sites improved more in post-I period (ratio of ORs 0.67, p=0.04). In logistic models, the intervention was independently positively associated with DVT performance during active-I period, and negatively associated with dysphagia performance post-I period. Quality improvement training was associated with early DVT improvement, but the effect was not sustained over time and was not seen with dysphagia screening. External quality improvement programmes may quickly boost performance but their effect may vary by indicator and may not sustain over time. 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/

  17. Optical dating of relict sand wedges and composite-wedge pseudomorphs in Flanders, Belgium

    DEFF Research Database (Denmark)

    Buylaert, Jan-Pieter; Ghysels, Günther; Murray, Andrew S.

    2009-01-01

    We report on quartz Optically Stimulated Luminescence (OSL) dating of the infill of 14 relict sand wedges and composite-wedge pseudomorphs at 5 different sites in Flanders, Belgium. A laboratory dose recovery test indicates that the single-aliquot regenerative-dose (SAR) procedure is suitable for...

  18. Study protocol: cluster randomised controlled trial to assess the clinical and cost effectiveness of a staff training intervention in inpatient mental health rehabilitation units in increasing service users' engagement in activities.

    Science.gov (United States)

    Killaspy, Helen; Cook, Sarah; Mundy, Tim; Craig, Thomas; Holloway, Frank; Leavey, Gerard; Marston, Louise; McCrone, Paul; Koeser, Leonardo; Arbuthnott, Maurice; Omar, Rumana Z; King, Michael

    2013-08-28

    This study focuses on people with complex and severe mental health problems who require inpatient rehabilitation. The majority have a diagnosis of schizophrenia whose recovery has been delayed due to non-response to first-line treatments, cognitive impairment, negative symptoms and co-existing problems such as substance misuse. These problems contribute to major impairments in social and everyday functioning necessitating lengthy admissions and high support needs on discharge to the community. Engagement in structured activities reduces negative symptoms of psychosis and may lead to improvement in function, but no trials have been conducted to test the efficacy of interventions that aim to achieve this. This study aims to investigate the clinical and cost-effectiveness of a staff training intervention to increase service users' engagement in activities. This is a single-blind, two-arm cluster randomised controlled trial involving 40 inpatient mental health rehabilitation units across England. Units are randomised on an equal basis to receive either standard care or a "hands-on", manualised staff training programme comprising three distinct phases (predisposing, enabling and reinforcing) delivered by a small team of psychiatrists, occupational therapists, service users and activity workers. The primary outcome is service user engagement in activities 12 months after randomisation, assessed using a standardised measure. Secondary outcomes include social functioning and costs and cost-effectiveness of care. The study will provide much needed evidence for a practical staff training intervention that has potential to improve service user functioning, reducing the need for hospital treatment and supporting successful community discharge. The trial is registered with Current Controlled Trials (Ref ISRCTN25898179).

  19. Psycho-education with problem solving (PEPS therapy for adults with personality disorder: A pragmatic multi-site community-based randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Duggan Conor

    2011-08-01

    Full Text Available Abstract Background Impairment in social functioning is a key component of personality disorder. Therefore psycho-education and problem solving (PEPS therapy may benefit people with this disorder. Psycho-education aims to educate, build rapport, and motivate people for problem solving therapy. Problem solving therapy aims to help clients solve interpersonal problems positively and rationally, thereby improving social functioning and reducing distress. PEPS therapy has been evaluated with community adults with personality disorder in an exploratory trial. At the end of treatment, compared to a wait-list control group, those treated with PEPS therapy showed better social functioning, as measured by the Social Functioning Questionnaire (SFQ. A definitive evaluation is now being conducted to determine whether PEPS therapy is a clinically and cost-effective treatment for people with personality disorder Methods This is a pragmatic, two-arm, multi-centre, parallel, randomised controlled clinical trial. The target population is community-dwelling adults with one or more personality disorder, as identified by the International Personality Disorder Examination (IPDE. Inclusion criteria are: Living in the community (including residential or supported care settings; presence of one or more personality disorder; aged 18 or over; proficiency in spoken English; capacity to provide informed consent. Exclusion criteria are: Primary diagnosis of a functional psychosis; insufficient degree of literacy, comprehension or attention to be able to engage in trial therapy and assessments; currently engaged in a specific programme of psychological treatment for personality disorder or likely to start such treatment during the trial period; currently enrolled in any other trial. Suitable participants are randomly allocated to PEPS therapy plus treatment as usual (TAU or TAU only. We aim to recruit 340 men and women. The primary outcome is social functioning as measured

  20. Effects of a multi-faceted program to increase influenza vaccine uptake among health care workers in nursing homes : A cluster randomised controlled trial

    NARCIS (Netherlands)

    Looijmans-van den Akker, I.; van Delden, J.J.M.; Verheij, T.J.M.; van der Sande, M.A.B.; van Essen, G.A.; Riphagen-Dalhuisen, J.; Hulscher, M.E.; Hak, E.

    2010-01-01

    Despite the recommendation of the Dutch association of nursing home physicians (NVVA) to be immunized against influenza, vaccine uptake among HCWs in nursing homes remains unacceptably low. Therefore we conducted a cluster randomised controlled trial among 33 Dutch nursing homes to assess the

  1. Behavioural graded activity results in better exercise adherence and more physical activity than usual care in people with osteoarthritis: a cluster-randomised trial

    NARCIS (Netherlands)

    Pisters, M.F.; Veenhof, C.; de Bakker, D.H.; Schellevis, F.G.; Dekker, J.

    2010-01-01

    Question: Does behavioural graded activity result in better exercise adherence and more physical activity than usual care in people with osteoarthritis of the hip or knee? Design: Analysis of secondary outcomes of a cluster-randomised trial with concealed allocation, assessor blinding, and

  2. Quality of care, risk management, and technology in obstetrics to reduce hospital-based maternal mortality in Senegal and Mali (QUARITE): a cluster-randomised trial.

    Science.gov (United States)

    Dumont, Alexandre; Fournier, Pierre; Abrahamowicz, Michal; Traoré, Mamadou; Haddad, Slim; Fraser, William D

    2013-07-13

    Maternal mortality is higher in west Africa than in most industrialised countries, so the development and validation of effective interventions is essential. We did a trial to assess the effect of a multifaceted intervention to promote maternity death reviews and onsite training in emergency obstetric care in referral hospitals with high maternal mortality rates in Senegal and Mali. We did a pragmatic cluster-randomised controlled trial, with hospitals as the units of randomisation and patients as the unit of analysis. 46 public first-level and second-level referral hospitals with more than 800 deliveries a year were enrolled, stratified by country and hospital type, and randomly assigned to either the intervention group (n=23) or the control group with no external intervention (n=23). All women who delivered in each of the participating facilities during the baseline and post-intervention periods were included. The intervention, implemented over a period of 2 years at the hospital level, consisted of an initial interactive workshop and quarterly educational clinically-oriented and evidence-based outreach visits focused on maternal death reviews and best practices implementation. The primary outcome was reduction of risk of hospital-based mortality. Analysis was by intention-to-treat and relied on the generalised estimating equations extension of the logistic regression model to account for clustering of women within hospitals. This study is registered with ClinicalTrials.gov, number ISRCTN46950658. 191,167 patients who delivered in the participating hospitals were analysed (95,931 in the intervention groups and 95,236 in the control groups). Overall, mortality reduction in intervention hospitals was significantly higher than in control hospitals (odds ratio [OR] 0·85, 95% CI 0·73-0·98, p=0·0299), but this effect was limited to capital and district hospitals, which mainly acted as first-level referral hospitals in this trial. There was no effect in second

  3. A THREE-STEP SPATIAL-TEMPORAL-SEMANTIC CLUSTERING METHOD FOR HUMAN ACTIVITY PATTERN ANALYSIS

    Directory of Open Access Journals (Sweden)

    W. Huang

    2016-06-01

    Full Text Available How people move in cities and what they do in various locations at different times form human activity patterns. Human activity pattern plays a key role in in urban planning, traffic forecasting, public health and safety, emergency response, friend recommendation, and so on. Therefore, scholars from different fields, such as social science, geography, transportation, physics and computer science, have made great efforts in modelling and analysing human activity patterns or human mobility patterns. One of the essential tasks in such studies is to find the locations or places where individuals stay to perform some kind of activities before further activity pattern analysis. In the era of Big Data, the emerging of social media along with wearable devices enables human activity data to be collected more easily and efficiently. Furthermore, the dimension of the accessible human activity data has been extended from two to three (space or space-time to four dimensions (space, time and semantics. More specifically, not only a location and time that people stay and spend are collected, but also what people “say” for in a location at a time can be obtained. The characteristics of these datasets shed new light on the analysis of human mobility, where some of new methodologies should be accordingly developed to handle them. Traditional methods such as neural networks, statistics and clustering have been applied to study human activity patterns using geosocial media data. Among them, clustering methods have been widely used to analyse spatiotemporal patterns. However, to our best knowledge, few of clustering algorithms are specifically developed for handling the datasets that contain spatial, temporal and semantic aspects all together. In this work, we propose a three-step human activity clustering method based on space, time and semantics to fill this gap. One-year Twitter data, posted in Toronto, Canada, is used to test the clustering-based method. The

  4. Efficacy and effectiveness of an rVSV-vectored vaccine expressing Ebola surface glycoprotein: interim results from the Guinea ring vaccination cluster-randomised trial.

    Science.gov (United States)

    Henao-Restrepo, Ana Maria; Longini, Ira M; Egger, Matthias; Dean, Natalie E; Edmunds, W John; Camacho, Anton; Carroll, Miles W; Doumbia, Moussa; Draguez, Bertrand; Duraffour, Sophie; Enwere, Godwin; Grais, Rebecca; Gunther, Stephan; Hossmann, Stefanie; Kondé, Mandy Kader; Kone, Souleymane; Kuisma, Eeva; Levine, Myron M; Mandal, Sema; Norheim, Gunnstein; Riveros, Ximena; Soumah, Aboubacar; Trelle, Sven; Vicari, Andrea S; Watson, Conall H; Kéïta, Sakoba; Kieny, Marie Paule; Røttingen, John-Arne

    2015-08-29

    A recombinant, replication-competent vesicular stomatitis virus-based vaccine expressing a surface glycoprotein of Zaire Ebolavirus (rVSV-ZEBOV) is a promising Ebola vaccine candidate. We report the results of an interim analysis of a trial of rVSV-ZEBOV in Guinea, west Africa. For this open-label, cluster-randomised ring vaccination trial, suspected cases of Ebola virus disease in Basse-Guinée (Guinea, west Africa) were independently ascertained by Ebola response teams as part of a national surveillance system. After laboratory confirmation of a new case, clusters of all contacts and contacts of contacts were defined and randomly allocated 1:1 to immediate vaccination or delayed (21 days later) vaccination with rVSV-ZEBOV (one dose of 2 × 10(7) plaque-forming units, administered intramuscularly in the deltoid muscle). Adults (age ≥18 years) who were not pregnant or breastfeeding were eligible for vaccination. Block randomisation was used, with randomly varying blocks, stratified by location (urban vs rural) and size of rings (≤20 vs >20 individuals). The study is open label and masking of participants and field teams to the time of vaccination is not possible, but Ebola response teams and laboratory workers were unaware of allocation to immediate or delayed vaccination. Taking into account the incubation period of the virus of about 10 days, the prespecified primary outcome was laboratory-confirmed Ebola virus disease with onset of symptoms at least 10 days after randomisation. The primary analysis was per protocol and compared the incidence of Ebola virus disease in eligible and vaccinated individuals in immediate vaccination clusters with the incidence in eligible individuals in delayed vaccination clusters. This trial is registered with the Pan African Clinical Trials Registry, number PACTR201503001057193. Between April 1, 2015, and July 20, 2015, 90 clusters, with a total population of 7651 people were included in the planned interim analysis. 48 of

  5. Restrictive versus liberal blood transfusion for acute upper gastrointestinal bleeding (TRIGGER): a pragmatic, open-label, cluster randomised feasibility trial.

    Science.gov (United States)

    Jairath, Vipul; Kahan, Brennan C; Gray, Alasdair; Doré, Caroline J; Mora, Ana; James, Martin W; Stanley, Adrian J; Everett, Simon M; Bailey, Adam A; Dallal, Helen; Greenaway, John; Le Jeune, Ivan; Darwent, Melanie; Church, Nicholas; Reckless, Ian; Hodge, Renate; Dyer, Claire; Meredith, Sarah; Llewelyn, Charlotte; Palmer, Kelvin R; Logan, Richard F; Travis, Simon P; Walsh, Timothy S; Murphy, Michael F

    2015-07-11

    Transfusion thresholds for acute upper gastrointestinal bleeding are controversial. So far, only three small, underpowered studies and one single-centre trial have been done. Findings from the single-centre trial showed reduced mortality with restrictive red blood cell (RBC) transfusion. We aimed to assess whether a multicentre, cluster randomised trial is a feasible method to substantiate or refute this finding. In this pragmatic, open-label, cluster randomised feasibility trial, done in six university hospitals in the UK, we enrolled all patients aged 18 years or older with new presentations of acute upper gastrointestinal bleeding, irrespective of comorbidity, except for exsanguinating haemorrhage. We randomly assigned hospitals (1:1) with a computer-generated randomisation sequence (random permuted block size of 6, without stratification or matching) to either a restrictive (transfusion when haemoglobin concentration fell below 80 g/L) or liberal (transfusion when haemoglobin concentration fell below 100 g/L) RBC transfusion policy. Neither patients nor investigators were masked to treatment allocation. Feasibility outcomes were recruitment rate, protocol adherence, haemoglobin concentration, RBC exposure, selection bias, and information to guide design and economic evaluation of the phase 3 trial. Main exploratory clinical outcomes were further bleeding and mortality at day 28. We did analyses on all enrolled patients for whom an outcome was available. This trial is registered, ISRCTN85757829 and NCT02105532. Between Sept 3, 2012, and March 1, 2013, we enrolled 936 patients across six hospitals (403 patients in three hospitals with a restrictive policy and 533 patients in three hospitals with a liberal policy). Recruitment rate was significantly higher for the liberal than for the restrictive policy (62% vs 55%; p=0·04). Despite some baseline imbalances, Rockall and Blatchford risk scores were identical between policies. Protocol adherence was 96% (SD 10) in

  6. Social Dancing and Incidence of Falls in Older Adults: A Cluster Randomised Controlled Trial.

    Science.gov (United States)

    Merom, Dafna; Mathieu, Erin; Cerin, Ester; Morton, Rachael L; Simpson, Judy M; Rissel, Chris; Anstey, Kaarin J; Sherrington, Catherine; Lord, Stephen R; Cumming, Robert G

    2016-08-01

    The prevention of falls among older people is a major public health challenge. Exercises that challenge balance are recognized as an efficacious fall prevention strategy. Given that small-scale trials have indicated that diverse dance styles can improve balance and gait of older adults, two of the strongest risk factors for falls in older people, this study aimed to determine whether social dance is effective in i) reducing the number of falls and ii) improving physical and cognitive fall-related risk factors. A parallel two-arm cluster randomized controlled trial was undertaken in 23 self-care retirement villages (clusters) around Sydney, Australia. Eligible villages had to have an appropriate hall for dancing, house at least 60 residents, and not be currently offering dance as a village activity. Retirement villages were randomised using a computer generated randomisation method, constrained using minimisation. Eligible participants had to be a resident of the village, be able to walk at least 50 m, and agree to undergo physical and cognitive testing without cognitive impairment. Residents of intervention villages (12 clusters) were offered twice weekly one-hour social dancing classes (folk or ballroom dancing) over 12 mo (80 h in total). Programs were standardized across villages and were delivered by eight dance teachers. Participants in the control villages (11 clusters) were advised to continue with their regular activities. falls during the 12 mo trial and Trail Making Tests. The Physiological Performance Assessment (i.e., postural sway, proprioception, reaction time, leg strength) and the Short Physical Performance Battery; health-related physical and mental quality of life from the Short-Form 12 (SF-12) Survey. Data on falls were obtained from 522 of 530 (98%) randomised participants (mean age 78 y, 85% women) and 424 (80%) attended the 12-mo reassessment, which was lower among folk dance participants (71%) than ballroom dancing (82%) or control

  7. Social Dancing and Incidence of Falls in Older Adults: A Cluster Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Dafna Merom

    2016-08-01

    Full Text Available The prevention of falls among older people is a major public health challenge. Exercises that challenge balance are recognized as an efficacious fall prevention strategy. Given that small-scale trials have indicated that diverse dance styles can improve balance and gait of older adults, two of the strongest risk factors for falls in older people, this study aimed to determine whether social dance is effective in i reducing the number of falls and ii improving physical and cognitive fall-related risk factors.A parallel two-arm cluster randomized controlled trial was undertaken in 23 self-care retirement villages (clusters around Sydney, Australia. Eligible villages had to have an appropriate hall for dancing, house at least 60 residents, and not be currently offering dance as a village activity. Retirement villages were randomised using a computer generated randomisation method, constrained using minimisation. Eligible participants had to be a resident of the village, be able to walk at least 50 m, an