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Sample records for centre cluster randomised

  1. Advance care planning - a multi-centre cluster randomised clinical trial

    DEFF Research Database (Denmark)

    Rietjens, Judith A C; Korfage, Ida J; Dunleavy, Lesley;

    2016-01-01

    BACKGROUND: Awareness of preferences regarding medical care should be a central component of the care of patients with advanced cancer. Open communication can facilitate this but can occur in an ad hoc or variable manner. Advance care planning (ACP) is a formalized process of communication between......, and improve their quality of life. METHODS/DESIGN: We will study the effects of the ACP program Respecting Choices on the quality of life of patients with advanced lung or colorectal cancer. In a phase III multicenter cluster randomised controlled trial, 22 hospitals in 6 countries will be randomised...

  2. Improving person-centred care in nursing homes through dementia-care mapping: design of a cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    van de Ven Geertje

    2012-01-01

    Full Text Available Abstract Background The effectiveness and efficiency of nursing-home dementia care are suboptimal: there are high rates of neuropsychiatric symptoms among the residents and work-related stress among the staff. Dementia-care mapping is a person-centred care method that may alleviate both the resident and the staff problems. The main objective of this study is to evaluate the effectiveness and cost-effectiveness of dementia-care mapping in nursing-home dementia care. Methods/Design The study is a cluster-randomised controlled trial, with nursing homes grouped in clusters. Studywise minimisation is the allocation method. Nursing homes in the intervention group will receive a dementia-care-mapping intervention, while the control group will receive usual care. The primary outcome measure is resident agitation, to be assessed with the Cohen-Mansfield Agitation Inventory. The secondary outcomes are resident neuropsychiatric symptoms, assessed with the Neuropsychiatric Inventory - Nursing Homes and quality of life, assessed with Qualidem and the EQ-5D. The staff outcomes are stress reactions, job satisfaction and job-stress-related absenteeism, and staff turnover rate, assessed with the Questionnaire about Experience and Assessment of Work, the General Health Questionnaire-12, and the Maastricht Job Satisfaction Scale for Health Care, respectively. We will collect the data from the questionnaires and electronic registration systems. We will employ linear mixed-effect models and cost-effectiveness analyses to evaluate the outcomes. We will use structural equation modelling in the secondary analysis to evaluate the plausibility of a theoretical model regarding the effectiveness of the dementia-care mapping intervention. We will set up process analyses, including focus groups with staff, to determine the relevant facilitators of and barriers to implementing dementia-care mapping broadly. Discussion A novelty of dementia-care mapping is that it offers an

  3. Child Centred Approach to Climate Change and Health Adaptation through Schools in Bangladesh: A Cluster Randomised Intervention Trial.

    Directory of Open Access Journals (Sweden)

    Md Iqbal Kabir

    Full Text Available Bangladesh is one of the most vulnerable countries to climate change. People are getting educated at different levels on how to deal with potential impacts. One such educational mode was the preparation of a school manual, for high school students on climate change and health protection endorsed by the National Curriculum and Textbook Board, which is based on a 2008 World Health Organization manual. The objective of this study was to test the effectiveness of the manual in increasing the knowledge level of the school children about climate change and health adaptation.This cluster randomized intervention trial involved 60 schools throughout Bangladesh, with 3293 secondary school students participating. School upazilas (sub-districts were randomised into intervention and control groups, and two schools from each upazila were randomly selected. All year seven students from both groups of schools sat for a pre-test of 30 short questions of binary response. A total of 1515 students from 30 intervention schools received the intervention through classroom training based on the school manual and 1778 students of the 30 control schools did not get the manual but a leaflet on climate change and health issues. Six months later, a post-intervention test of the same questionnaire used in the pre-test was performed at both intervention and control schools. The pre and post test scores were analysed along with the demographic data by using random effects model.None of the various school level and student level variables were significantly different between the control and intervention group. However, the intervention group had a 17.42% (95% CI: 14.45 to 20.38, P = <0.001 higher score in the post-test after adjusting for pre-test score and other covariates in a multi-level linear regression model.These results suggest that school-based intervention for climate change and health adaptation is effective for increasing the knowledge level of school children on

  4. No identifiable Hb1Ac or lifestyle change after a comprehensive diabetes programme including motivational interviewing: A cluster randomised trial

    NARCIS (Netherlands)

    Jansink, R.M.E.; Braspenning, J.C.C.; Keizer, E.; Weijden, T. van der; Elwyn, G.; Grol, R.P.T.M.

    2013-01-01

    Abstract Objective. To study the effectiveness of a comprehensive diabetes programme in general practice that integrates patient-centred lifestyle counselling into structured diabetes care. Design and setting. Cluster randomised trial in general practices. Intervention. Nurse-led structured diabetes

  5. Improving person-centred care in nursing homes through dementia-care mapping: design of a cluster-randomised controlled trial.

    OpenAIRE

    van de Ven Geertje; Draskovic Irena; Adang Eddy MM; Donders Rogier ART; Post Aukje; Zuidema Sytse U; Koopmans Raymond TCM; Vernooij-Dassen Myrra JFJ

    2012-01-01

    Abstract Background The effectiveness and efficiency of nursing-home dementia care are suboptimal: there are high rates of neuropsychiatric symptoms among the residents and work-related stress among the staff. Dementia-care mapping is a person-centred care method that may alleviate both the resident and the staff problems. The main objective of this study is to evaluate the effectiveness and cost-effectiveness of dementia-care mapping in nursing-home dementia care. Methods/Design The study is...

  6. Community involvement in dengue vector control: cluster randomised trial

    OpenAIRE

    Vanlerberghe, V; Toledo, M. E.; Rodríguez, M.; Gomez, D.; Baly, A; Benitez, J. R.; Van der Stuyft, P.

    2009-01-01

    OBJECTIVE: To assess the effectiveness of an integrated community based environmental management strategy to control Aedes aegypti, the vector of dengue, compared with a routine strategy. DESIGN: Cluster randomised trial. SETTING: Guantanamo, Cuba. PARTICIPANTS: 32 circumscriptions (around 2000 inhabitants each). INTERVENTIONS: The circumscriptions were randomly allocated to control clusters (n=16) comprising routine Aedes control programme (entomological surveillance, source reduction, selec...

  7. Community involvement in dengue vector control: cluster randomised trial

    OpenAIRE

    Vanlerberghe, V; Toledo, M. E.; Rodriguez, M.; Gómez, D.; Baly, D; Baly, A; Benítez, J. R.; Van der Stuyft, P.

    2010-01-01

    Objective: To assess the effectiveness of an integrated community based environmental management strategy to control Aedes aegypti, the vector of dengue, compared with a routine strategy. Design Cluster randomised trial. Setting Guantanamo, Cuba. Participants 32 circumscriptions (around 2000 inhabitants each). Interventions: The circumscriptions were randomly allocated to control clusters (n=16) comprising routine Aedes control programme (entomological surveillance, sourc...

  8. Developing, delivering and documenting rehabilitation in a multi-centre randomised controlled surgical trial

    OpenAIRE

    Handoll, H. H. G.; Goodchild, L; Brealey, S. D.; Hanchard, N. C. A.; Jefferson, L.; Keding, A; Rangan, A.

    2014-01-01

    Objectives A rigorous approach to developing, delivering and documenting rehabilitation within randomised controlled trials of surgical interventions is required to underpin the generation of reliable and usable evidence. This article describes the key processes used to ensure provision of good quality and comparable rehabilitation to all participants of a multi-centre randomised controlled trial comparing surgery with conservative treatment of proximal humeral fractures in adults. Methods Th...

  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. Multiple imputation methods for bivariate outcomes in cluster randomised trials.

    Science.gov (United States)

    DiazOrdaz, K; Kenward, M G; Gomes, M; Grieve, R

    2016-09-10

    Missing observations are common in cluster randomised trials. The problem is exacerbated when modelling bivariate outcomes jointly, as the proportion of complete cases is often considerably smaller than the proportion having either of the outcomes fully observed. Approaches taken to handling such missing data include the following: complete case analysis, single-level multiple imputation that ignores the clustering, multiple imputation with a fixed effect for each cluster and multilevel multiple imputation. We contrasted the alternative approaches to handling missing data in a cost-effectiveness analysis that uses data from a cluster randomised trial to evaluate an exercise intervention for care home residents. We then conducted a simulation study to assess the performance of these approaches on bivariate continuous outcomes, in terms of confidence interval coverage and empirical bias in the estimated treatment effects. Missing-at-random clustered data scenarios were simulated following a full-factorial design. Across all the missing data mechanisms considered, the multiple imputation methods provided estimators with negligible bias, while complete case analysis resulted in biased treatment effect estimates in scenarios where the randomised treatment arm was associated with missingness. Confidence interval coverage was generally in excess of nominal levels (up to 99.8%) following fixed-effects multiple imputation and too low following single-level multiple imputation. Multilevel multiple imputation led to coverage levels of approximately 95% throughout. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd. PMID:26990655

  11. An occupational therapy intervention for residents with stroke related disabilities in UK care homes (OTCH): cluster randomised controlled trial

    OpenAIRE

    Sackley, Catherine M.; Walker, Marion F; Burton, Chris R; Watkins, Caroline L; Mant, Jonathan; Roalfe, Andrea K; Wheatley, Keith; Sheehan, Bart; Sharp, Leslie; Stant, Katie E.; Fletcher-Smith, Joanna; Steel, Kerry; Wilde, Kate; Irvine, Lisa; Peryer, Guy

    2015-01-01

    Objective To evaluate the clinical efficacy of an established programme of occupational therapy in maintaining functional activity and reducing further health risks from inactivity in care home residents living with stroke sequelae. Design Pragmatic, parallel group, cluster randomised controlled trial. Setting 228 care homes (>10 beds each), both with and without the provision of nursing care, local to 11 trial administrative centres across the United Kingdom. Participants 1042 ca...

  12. Feasibility study of an integrated stroke self-management programme : a cluster-randomised controlled trial

    OpenAIRE

    Jones, Fiona; Gage, Heather; Drummond, Avril; Bhalla, Ajay; Grant, Robert; Lennon, Sheila; McKevitt, Christopher; Riazi, Afsane; Liston, Matthew

    2016-01-01

    OBJECTIVES: To test the feasibility of conducting a controlled trial into the effectiveness of a self-management programme integrated into stroke rehabilitation. DESIGN: A feasibility cluster-randomised design was utilised with stroke rehabilitation teams as units of randomisation. SETTING: Community-based stroke rehabilitation teams in London. PARTICIPANTS: 78 patients with a diagnosis of stroke requiring community based rehabilitation. INTERVENTION: The interv...

  13. Assessment of data quality in an international multi-centre randomised trial of coronary artery surgery

    Directory of Open Access Journals (Sweden)

    Bochenek Andrzej

    2011-09-01

    Full Text Available Abstract Background ART is a multi-centre randomised trial of cardiac surgery which provided a unique opportunity to evaluate the data from a large number of centres from a variety of countries. We attempted to assess data quality, including recruitment rates, timeliness and completeness of the data obtained from the centres in different socio-economic strata. Methods The analysis was based on the 2-page CRF completed at the 6 week follow-up. CRF pages were categorised into "clean" (no edit query and "dirty" (any incomplete, inconsistent or illegible data. The timelines were assessed on the basis of the time interval from the visit and receipt of complete CRF. Data quality was defined as the number of data queries (in percent and time delay (in days between visit and receipt of correct data. Analyses were stratified according to the World Bank definitions into: "Developing" countries (Poland, Brazil and India and "Developed" (Italy, UK, Austria and Australia. Results There were 18 centres in the "Developed" and 10 centres in the "Developing" countries. The rate of enrolment did not differ significantly by economic level ("Developing":4.1 persons/month, "Developed":3.7 persons/month. The time interval for the receipt of data was longer for "Developing" countries (median:37 days compared to "Developed" ones (median:11 days (p Conclusions In this study we showed that data quality was comparable between centres from "Developed" and "Developing" countries. Data was received in a less timely fashion from Developing countries and appropriate systems should be instigated to minimize any delays. Close attention should be paid to the training of centres and to the central management of data quality. Trial registration ISRCTN46552265

  14. 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

  15. Predictors of employment for people with severe mental illness : results of an international six-centre randomised controlled trial

    NARCIS (Netherlands)

    Catty, Jocelyn; Lissouba, Pascale; White, Sarah; Becker, Thomas; Drake, Robert E.; Fioritti, Angelo; Knapp, Martin; Lauber, Christoph; Roessler, Wulf; Tomov, Toma; Van Busschbach, Jooske; Wiersma, Durk; Burns, Tom; Rossler, W.

    2008-01-01

    Background An international six-centre randomised controlled trial comparing individual placement and support (IPS) with usual vocational rehabilitation for people with serious mental illness found IPS to be more effective for all vocational outcomes. Aims To determine which patients with severe men

  16. A randomised controlled trial of a client-centred self-care intervention after stroke

    DEFF Research Database (Denmark)

    Guidetti, Susanne; Ytterberg, Charlotte

    2011-01-01

    PURPOSE: The aim of this randomised controlled pilot study of a client-centred self-care intervention (CCSCI) in individuals with stroke was to study (i) the feasibility of the study design, (ii) effects up to 12 months on activities of daily living (ADL), use of informal care and home help...... services and the caregiver burden. METHOD: An intervention group (IG) received CCSCI and a control group (CG) received ordinary training. Forty individuals with stroke (IG n = 19, CG n = 21) were included. Data were collected at 3, 6 and 12 months using established instruments. RESULTS: After 12 months 24...... people remained in the study (IG = 10, CG = 14). The data collection method was acceptable to most participants. At 12 months there were no differences in ADL, use of services or caregiver's burden. Both groups improved significantly and clinically important improvements were achieved by 80% in the IG...

  17. Acupuncture for persistent allergic rhinitis: a multi-centre, randomised, controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Kang Kyung-Won

    2009-07-01

    Full Text Available Abstract Background Allergic rhinitis is one of the most common health complaints worldwide. Complementary and alternative medical approaches have been employed to relieve allergic rhinitis symptoms and to avoid the side effects of conventional medication. Acupuncture has been widely used to treat patients with allergic rhinitis, but the available evidence of its effectiveness is insufficient. Our objective is to evaluate the effectiveness of acupuncture in patients in Korea and China with persistent allergic rhinitis compared to sham acupuncture treatment or waitlist control. Methods This study consists of a multi-centre (two centres in Korea and two centres in China, randomised, controlled trial with three parallel arms (active acupuncture, sham acupuncture, and waitlist group. The active acupuncture and sham acupuncture groups will receive real or sham acupuncture treatment, respectively, three times per week for a total of 12 sessions over four weeks. Post-treatment follow-up will be performed a month later to complement these 12 acupuncture sessions. Participants in the waitlist group will not receive real or sham acupuncture treatments during this period but will only be required to keep recording their symptoms in a daily diary. After four weeks, the same treatment given to the active acupuncture group will be provided to the waitlist group. Discussion This trial will provide evidence for the effectiveness of acupuncture as a treatment for persistent allergic rhinitis. The primary outcome between groups is a change in the self-reported total nasal symptom score (i.e., nasal obstruction, rhinorrhea, sneezing, and itching from baseline at the fourth week. Secondary outcome measures include the Rhinitis Quality of Life Questionnaire score and total non-nasal symptom score (i.e., headache, itching, pain, eye-dropping. The quantity of conventional relief medication used during the follow-up period is another secondary outcome measure. Trial

  18. Evaluation of an evidence-based guidance on the reduction of physical restraints in nursing homes: a cluster-randomised controlled trial [ISRCTN34974819

    Directory of Open Access Journals (Sweden)

    Haastert Burkhard

    2009-09-01

    Full Text Available Abstract Background Physical restraints are regularly applied in German nursing homes. Their frequency varies substantially between centres. Beneficial effects of physical restraints have not been proven, however, observational studies and case reports suggest various adverse effects. We developed an evidence-based guidance on this topic. The present study evaluates the clinical efficacy and safety of an intervention programme based on this guidance aimed to reduce physical restraints and minimise centre variations. Methods/Design Cluster-randomised controlled trial with nursing homes randomised either to the intervention group or to the control group with standard information. The intervention comprises a structured information programme for nursing staff, information materials for legal guardians and residents' relatives and a one-day training workshop for nominated nurses. A total of 36 nursing home clusters including approximately 3000 residents will be recruited. Each cluster has to fulfil the inclusion criteria of at least 20% prevalence of physical restraints at baseline. The primary endpoint is the number of residents with at least one physical restraint at six months. Secondary outcome measures are the number of falls and fall-related fractures. Discussion If successful, the intervention should be implemented throughout Germany. In case the intervention does not succeed, a three-month pre-post-study with an optimised intervention programme within the control group will follow the randomised trial. Trial registration ISRCTN34974819

  19. Evaluation of an evidence-based guidance on the reduction of physical restraints in nursing homes: a cluster-randomised controlled trial [ISRCTN34974819

    Science.gov (United States)

    Haut, Antonie; Köpke, Sascha; Gerlach, Anja; Mühlhauser, Ingrid; Haastert, Burkhard; Meyer, Gabriele

    2009-01-01

    Background Physical restraints are regularly applied in German nursing homes. Their frequency varies substantially between centres. Beneficial effects of physical restraints have not been proven, however, observational studies and case reports suggest various adverse effects. We developed an evidence-based guidance on this topic. The present study evaluates the clinical efficacy and safety of an intervention programme based on this guidance aimed to reduce physical restraints and minimise centre variations. Methods/Design Cluster-randomised controlled trial with nursing homes randomised either to the intervention group or to the control group with standard information. The intervention comprises a structured information programme for nursing staff, information materials for legal guardians and residents' relatives and a one-day training workshop for nominated nurses. A total of 36 nursing home clusters including approximately 3000 residents will be recruited. Each cluster has to fulfil the inclusion criteria of at least 20% prevalence of physical restraints at baseline. The primary endpoint is the number of residents with at least one physical restraint at six months. Secondary outcome measures are the number of falls and fall-related fractures. Discussion If successful, the intervention should be implemented throughout Germany. In case the intervention does not succeed, a three-month pre-post-study with an optimised intervention programme within the control group will follow the randomised trial. Trial registration ISRCTN34974819 PMID:19735564

  20. A multi-centre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: Study protocol for a randomised controlled trial

    OpenAIRE

    Logan Pip A; Leighton Mat P; Walker Marion F; Armstrong Sarah; Gladman John R F; Sach Tracey H; Smith Shirley; Newell Ossie; Avery Tony; Williams Hywel; Scott James; O’Neil Kathleen; McCluskey Annie; Leach Simon; Barer David

    2012-01-01

    Abstract Background Up to 42% of all stroke patients do not get out of the house as much as they would like. This can impede a person’s quality of life. This study is testing the clinical effectiveness and cost effectiveness of a new outdoor mobility rehabilitation intervention by comparing it to usual care. Methods/design This is a multi-centre parallel group individually randomised, controlled trial. At least 506 participants will be recruited through 15 primary and secondary care settings ...

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

    NARCIS (Netherlands)

    Verbakel, N.J.; Langelaan, M.; Verheij, T.J.M.; Wagner, C.; Zwart, D.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 was

  2. A cluster randomised controlled trial of an occupational therapy intervention for residents with stroke living in UK care homes (OTCH: study protocol

    Directory of Open Access Journals (Sweden)

    Sackley Cath M

    2012-07-01

    Full Text Available Abstract Background The occupational therapy (OT in care homes study (OTCH aims to investigate the effect of a targeted course of individual OT (with task training, provision of adaptive equipment, minor environmental adaptations and staff education for stroke survivors living in care homes, compared to usual care. Methods/Design A cluster randomised controlled trial of United Kingdom (UK care homes (n = 90 with residents (n = 900 who have suffered a stroke or transient ischaemic attack (TIA, and who are not receiving end-of-life care. Homes will be stratified by centre and by type of care provided and randomised (50:50 using computer generated blocked randomisation within strata to receive either the OT intervention (3 months intervention from an occupational therapist or control (usual care. Staff training on facilitating independence and mobility and the use of adaptive equipment, will be delivered to every home, with control homes receiving this after the 12 month follow-up. Allocation will be concealed from the independent assessors, but the treating therapists, and residents will not be masked to the intervention. Measurements are taken at baseline prior to randomisation and at 3, 6 and 12 months post randomisation. The primary outcome measure is independence in self-care activities of daily living (Barthel Activities of Daily Living Index. Secondary outcome measures are mobility (Rivermead Mobility Index, mood (Geriatric Depression Scale, preference based quality of life measured from EQ-5D and costs associated with each intervention group. Quality adjusted life years (QALYs will be derived based on the EQ-5D scores. Cost effectiveness analysis will be estimated and measured by incremental cost effectiveness ratio. Adverse events will be recorded. Discussion This study will be the largest cluster randomised controlled trial of OT in care homes to date and will clarify the currently inconclusive literature on the efficacy of OT for

  3. Preoperative airway assessment - experience gained from a multicentre cluster randomised trial and the Danish Anaesthesia Database

    DEFF Research Database (Denmark)

    Nørskov, Anders Kehlet

    2016-01-01

    prospectively and compared with existing practice for airway assessment in a randomised trial setting. The first objective of this thesis was to quantify the proportion of unanticipated difficult intubation and difficult mask ventilation in Denmark. The second objective was to design a cluster randomised trial...... anticipations of airway difficulties was compared with actual airway management conditions, thus enabling an estimation of the proportion of unanticipated difficulties with intubation and mask ventilation. Papers 2 and 3 outline the methodology and the pre-trial calculations and considerations leading...... to the DIFFICAIR trial described in Paper 4. The trial was designed to randomise anaesthesia department to either thorough education in, and subsequent use of the SARI for preoperative airway assessment or to continue usual care. Registration of the SARI in DAD was made mandatory in SARI departments and impossible...

  4. Inadequate reporting of research ethics review and informed consent in cluster randomised trials: review of random sample of published trials

    OpenAIRE

    Taljaard, Monica; McRae, Andrew D; Weijer, Charles; Bennett, Carol; Dixon, Stephanie; Taleban, Julia; Skea, Zoe; Eccles, Martin P.; Brehaut, Jamie C; Donner, Allan; Saginur, Raphael; Boruch, Robert F; Grimshaw, Jeremy M.

    2011-01-01

    Objectives To investigate the extent to which authors of cluster randomised trials adhered to two basic requirements of the World Medical Association’s Declaration of Helsinki and the International Committee of Medical Journal Editors’ uniform requirements for manuscripts (namely, reporting of research ethics review and informed consent), to determine whether the adequacy of reporting has improved over time, and to identify characteristics of cluster randomised trials associated with reportin...

  5. General Practitioner Antimicrobial Stewardship Programme Study (GAPS): protocol for a cluster randomised controlled trial

    OpenAIRE

    Avent, Minyon L.; Hansen, Malene Plejdrup; Gilks, Charles; Del Mar, Chris; Halton, Kate; Sidjabat, Hanna; Hall, Lisa; Dobson, Annette; Paterson, David L.; van Driel, Mieke L.

    2016-01-01

    Background There is a strong link between antibiotic consumption and the rate of antibiotic resistance. In Australia, the vast majority of antibiotics are prescribed by general practitioners, and the most common indication is for acute respiratory infections. The aim of this study is to assess if implementing a package of integrated, multifaceted interventions reduces antibiotic prescribing for acute respiratory infections in general practice. Methods/design This is a cluster randomised trial...

  6. 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

  7. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856

    OpenAIRE

    Krämer Jürgen; Knauer Christine; Mansmann Ulrich; Witte Steffen; Streitberger Konrad; Scharf Hanns-Peter; Victor Norbert

    2004-01-01

    Abstract Background Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. Methods 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third co...

  8. A multi-centre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: Study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Logan Pip A

    2012-06-01

    Full Text Available Abstract Background Up to 42% of all stroke patients do not get out of the house as much as they would like. This can impede a person’s quality of life. This study is testing the clinical effectiveness and cost effectiveness of a new outdoor mobility rehabilitation intervention by comparing it to usual care. Methods/design This is a multi-centre parallel group individually randomised, controlled trial. At least 506 participants will be recruited through 15 primary and secondary care settings and will be eligible if they are over 18 years of age, have had a stroke and wish to get out of the house more often. Participants are being randomly allocated to either the intervention group or the control group. Intervention group participants receive up to 12 rehabilitation outdoor mobility sessions over up to four months. The main component of the intervention is repeated practice of outdoor mobility with a therapist. Control group participants are receiving the usual intervention for outdoor mobility limitations: verbal advice and provision of leaflets provided over one session. Outcome measures are being collected using postal questionnaires, travel calendars and by independent assessors. The primary outcome measure is the Social Function domain of the SF36v2 quality of life assessment six months after recruitment. The secondary outcome measures include: functional ability, mobility, the number of journeys (monthly travel diaries, satisfaction with outdoor mobility, mood, health-related quality of life, resource use of health and social care. Carer mood information is also being collected. The mean Social Function score of the SF-36v2 will be compared between treatment arms using a multiple membership form of mixed effects multiple regression analysis adjusting for centre (as a fixed effect, age and baseline Social Function score as covariates and therapist as a multiple membership random effect. Regression coefficients and 95% confidence

  9. Globular Clusters at the Centre of the Fornax Cluster: Tracing Interactions Between Galaxies

    CERN Document Server

    Bassino, L P; Faifer, F R; Forte, J C; Dirsch, B; Geisler, D; Schuberth, Y

    2006-01-01

    We present the combined results of two investigations: a large-scale study of the globular cluster system (GCS) around NGC 1399, the central galaxy of the Fornax cluster, and a study of the GCSs around NGC 1374, NGC 1379 and NGC 1387, three low-luminosity early-type galaxies located close to the centre of the same cluster. In both cases, the data consist of images from the wide-field MOSAIC Imager of the CTIO 4-m telescope, obtained with Washington C and Kron-Cousins R filters, which provide good metallicity resolution. The colour distributions and radial projected densities of the GCSs are analyzed. We focus on the properties of the GCSs that trace possible interaction processes between the galaxies, such as tidal stripping of globular clusters. For the blue globular clusters, we find tails between NGC 1399 and neighbouring galaxies in the azimuthal projected distribution, and the three low-luminosity galaxies show low specific frequencies and a low proportion of blue GCs.

  10. Individual placement and support (IPS) for patients with offending histories: the IPSOH feasibility cluster randomised trial protocol

    Science.gov (United States)

    Khalifa, N; Talbot, E; Schneider, J; Walker, D M; Bates, P; Bird, Y; Davies, D; Brookes, C; Hall, J; Völlm, B

    2016-01-01

    Introduction People with involvement in forensic psychiatric services face many obstacles to employment, arising from their offending, as well as their mental health problems. This study aims to assess the feasibility of conducting a randomised controlled trial (RCT) to evaluate the effectiveness of individual placement and support (IPS), in improving employment rates and associated psychosocial outcomes in forensic psychiatric populations. IPS has been found consistently to achieve employment rates above 50% in psychiatric patients without a history of involvement in criminal justice services. Methods/design This is a single-centre feasibility cluster RCT. Clusters will be defined according to clinical services in the community forensic services of Nottinghamshire Healthcare NHS Foundation Trust (NHCT). IPS will be implemented into 2 of the randomly assigned intervention clusters in the community forensic services of NHCT. A feasibility cluster RCT will estimate the parameters required to design a full RCT. The primary outcome is the proportion of people in open employment at 12-month follow-up. Secondary outcome measures will include employment, educational activities, psychosocial and economic outcomes, as well as reoffending rates. Outcome measures will be recorded at baseline, 6 months and 12 months. In accordance with the UK Medical Research Council guidelines on the evaluation of complex interventions, a process evaluation will be carried out; qualitative interviews with patients and staff will explore general views of IPS as well as barriers and facilitators to implementation. Fidelity reviews will assess the extent to which the services follow the principles of IPS prior, during and at the end of the trial. Ethics and dissemination Ethical approval was obtained from the East Midlands Research Ethics Committee-Nottingham 1 (REC reference number 15/EM/0253). Final and interim reports will be prepared for project funders, the study sponsor and clinical

  11. 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

  12. WHEDA study: Effectiveness of occupational therapy at home for older people with dementia and their caregivers - the design of a pragmatic randomised controlled trial evaluating a Dutch programme in seven German centres

    OpenAIRE

    Vernooij-Dassen Myrra; Schornstein Katrin; Leonhart Rainer; Graff Maud; Voigt-Radloff Sebastian; Olde-Rikkert Marcel; Huell Michael

    2009-01-01

    Abstract Background A recent Dutch mono-centre randomised controlled trial has shown that occupational therapy improves daily functioning in dementia. The aim of this present study is to compare the effects of the Dutch community occupational therapy programme with a community occupational therapy consultation on daily functioning in older people with mild or moderate dementia and their primary caregivers in a German multi-centre context. Methods/Design A multi-centre single blind randomised ...

  13. The Infant Feeding Activity and Nutrition Trial (INFANT an early intervention to prevent childhood obesity: Cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Campbell Karen

    2008-03-01

    Full Text Available Abstract Background Multiple factors combine to support a compelling case for interventions that target the development of obesity-promoting behaviours (poor diet, low physical activity and high sedentary behaviour from their inception. These factors include the rapidly increasing prevalence of fatness throughout childhood, the instigation of obesity-promoting behaviours in infancy, and the tracking of these behaviours from childhood through to adolescence and adulthood. The Infant Feeding Activity and Nutrition Trial (INFANT aims to determine the effectiveness of an early childhood obesity prevention intervention delivered to first-time parents. The intervention, conducted with parents over the infant's first 18 months of life, will use existing social networks (first-time parent's groups and an anticipatory guidance framework focusing on parenting skills which support the development of positive diet and physical activity behaviours, and reduced sedentary behaviours in infancy. Methods/Design This cluster-randomised controlled trial, with first-time parent groups as the unit of randomisation, will be conducted with a sample of 600 first-time parents and their newborn children who attend the first-time parents' group at Maternal and Child Health Centres. Using a two-stage sampling process, local government areas in Victoria, Australia will be randomly selected at the first stage. At the second stage, a proportional sample of first-time parent groups within selected local government areas will be randomly selected and invited to participate. Informed consent will be obtained and groups will then be randomly allocated to the intervention or control group. Discussion The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge this will be the first randomised trial internationally to demonstrate whether an early health promotion program delivered to first-time parents in their existing social groups

  14. Pilates based core stability training in ambulant individuals with multiple sclerosis: protocol for a multi-centre randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Freeman Jennifer

    2012-04-01

    Full Text Available Abstract Background People with Multiple Sclerosis (MS frequently experience balance and mobility impairments, including reduced trunk stability. Pilates-based core stability training, which is aimed at improving control of the body's stabilising muscles, is popular as a form of exercise with people with MS and therapists. A replicated single case series study facilitated by the Therapists in MS Group in the United Kingdom (UK provides preliminary evidence that this approach can improve balance and mobility in ambulant people with MS; further evidence is needed to substantiate these findings to ensure that limited time, energy, finances and resources are used to best effect. This study builds upon the pilot work undertaken in the case series study by implementing a powered randomised controlled study, with the aims of: 1 Establishing the effectiveness of core stability training 2 Comparing core stability training with standardised physiotherapy exercise 3 Exploring underlying mechanisms of change associated with this intervention Methods This is a multi-centre, double blind, block randomised, controlled trial. Eligible participants will be recruited from 4 UK centres. Participants will be randomly allocated to one of three groups: Pilates based core stability training, standardised physiotherapy exercise or contract-relax relaxation sessions (placebo control. All will receive face to face training sessions over a 12 week period; together with a 15 minute daily home programme. All will be assessed by a blinded assessor before training, at the end of the 12 week programme and at 4 week follow-up. The primary outcome measure is the 10 metre timed walk. Secondary outcome measures are the MS walking Scale (MSWS-12, the Functional Reach (forwards and lateral, a 10 point Numerical Rating Scale to determine "Difficulty in carrying a drink when walking", and the Activities-specific Balance Confidence (ABC Scale. In addition, ultrasound imaging of the

  15. Hypervelocity stars from young stellar clusters in the Galactic Centre

    CERN Document Server

    Fragione, Giacomo; Kroupa, Pavel

    2016-01-01

    The enormous velocities of the so called hypervelocity stars (HVSs) derive, likely, from close interactions with massive black holes, binary stars encounters or supernova explosions. In this paper, we investigate the origin of hypervelocity stars as consequence of the close interaction between the Milky Way central massive black hole and a passing-by young stellar cluster. We found that both single and binary HVSs may be generated in a burst-like event, as the cluster passes near the orbital pericentre. High velocity stars will move close to the initial cluster orbital plane and in the direction of the cluster orbital motion at the pericentre. The binary fraction of these HVS jets depends on the primordial binary fraction in the young cluster. The level of initial mass segregation determines the value of the average mass of the ejected stars. Some binary stars will merge, continuing their travel across and out of the Galaxy as blue stragglers.

  16. The Scandinavian Propaten(®) trial - 1-year patency of PTFE vascular prostheses with heparin-bonded luminal surfaces compared to ordinary pure PTFE vascular prostheses - a randomised clinical controlled multi-centre trial

    DEFF Research Database (Denmark)

    Lindholt, J S; Gottschalksen, B; Johannesen, N;

    2011-01-01

    To compare 1-year potencies' of heparin-bonded PTFE [(Hb-PTFE) (Propaten(®))] grafts with those of ordinary polytetraflouroethylene (PTFE) grafts in a blinded, randomised, clinically controlled, multi-centre study.......To compare 1-year potencies' of heparin-bonded PTFE [(Hb-PTFE) (Propaten(®))] grafts with those of ordinary polytetraflouroethylene (PTFE) grafts in a blinded, randomised, clinically controlled, multi-centre study....

  17. Putting telemedicine to the test: design and performance of a multi-centre randomised controlled trial and economic evaluation of joint tele-consultations

    OpenAIRE

    Wallace, P.; Haines, A.; Harrison, R; Barber, J; Thompson, S; Roberts, J.; Jacklin, P.; Lewis, L; Wainwright, P.; , ForTheVirtualOutreachProjectGroup

    2002-01-01

    BACKGROUND: Appropriate information flow is crucial to the care of patients, particularly at the interface between primary and secondary care. Communication problems can result from inadequate organisation and training, There is a major expectation that information and communication technologies may offer solutions, but little reliable evidence. This paper reports the design and performance of a multi-centre randomised controlled trial (RCT), unparalleled in telemedicine research in either sc...

  18. Design and performance of a multi-centre randomised controlled trial and economic evaluation of joint tele-consultations [ISRCTN54264250

    OpenAIRE

    Thompson Simon; Barber Julie A; Harrison Robert; Haines Andrew; Wallace Paul; Roberts Jennifer; Jacklin Paul B; Lewis Leo; Wainwright Paul

    2002-01-01

    Abstract Background Appropriate information flow is crucial to the care of patients, particularly at the interface between primary and secondary care. Communication problems can result from inadequate organisation and training, There is a major expectation that information and communication technologies may offer solutions, but little reliable evidence. This paper reports the design and performance of a multi-centre randomised controlled trial (RCT), unparalleled in telemedicine research in e...

  19. A multi-centre randomised phase III trial of Dexamethasone vs Dexamethasone and diethylstilbestrol in castration-resistant prostate cancer: immediate vs deferred Diethylstilbestrol

    OpenAIRE

    Shamash, J; Powles, T; Sarker, S J; Protheroe, A; Mithal, N; Mills, R.; Beard, R; Wilson, P; Tranter, N.; O'Brien, N; McFaul, S; Oliver, T

    2011-01-01

    Background: The role of further hormone therapy in castration-resistant prostate cancer (CRPC) remains unclear. We performed a multi-centre randomised phase III study comparing the use of Dexamethasone, Aspirin, and immediate addition of Diethylstilbestrol (DAiS) vs Dexamethasone, Aspirin, and deferred (until disease progression) addition of Diethylstilbestrol (DAdS). Methods: From 2001 to 2008, 270 men with chemotherapy-naive CRPC were randomly assigned, in a 1 : 1 ratio, to receive either D...

  20. Perioperative medication management: expanding the role of the preadmission clinic pharmacist in a single centre, randomised controlled trial of collaborative prescribing

    OpenAIRE

    Hale, A.R.; Coombes, I D; Stokes, J.; D. McDougall; Whitfield, K; Maycock, E; Nissen, L

    2013-01-01

    Objectives Current evidence to support non-medical prescribing is predominantly qualitative, with little evaluation of accuracy, safety and appropriateness. Our aim was to evaluate a new model of service for the Australia healthcare system, of inpatient medication prescribing by a pharmacist in an elective surgery preadmission clinic (PAC) against usual care, using an endorsed performance framework. Design Single centre, randomised controlled, two-arm trial. Setting Elective surgery PAC in a ...

  1. Recruitment issues when primary care population clusters are used in randomised controlled clinical trials: climbing mountains or pushing boulders uphill?

    Science.gov (United States)

    Hoddinott, Pat; Britten, Jane; Harrild, Kirsten; Godden, David J

    2007-05-01

    Cluster randomised controlled trials for health promotion, education, public health or organisational change interventions are becoming increasingly common to inform evidence-based policy. However, there is little published methodological evidence on recruitment strategies for primary care population clusters. In this paper, we discuss how choosing which population cluster to randomise can impact on the practicalities of recruitment in primary care. We describe strategies developed through our experiences of recruiting primary care organisations to participate in a national randomised controlled trial of a policy to provide community breastfeeding groups for pregnant and breastfeeding mothers, the BIG (Breastfeeding in Groups) trial. We propose an iterative qualitative approach to recruitment; collecting data generated through the recruitment process, identifying themes and using the constant comparative method of analysis. This can assist in developing successful recruitment strategies and contrasts with the standardised approach commonly used when recruiting individuals to participate in randomised controlled trials. Recruiting primary care population clusters to participate in trials is currently an uphill battle in Britain. It is a complex process, which can benefit from applying qualitative methods to inform trial design and recruitment strategy. Recruitment could be facilitated if health service managers were committed to supporting peer reviewed, funded and ethics committee approved research at national level. PMID:16996320

  2. 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

  3. Educational outreach to general practitioners reduces children's asthma symptoms: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sladden Michael

    2007-09-01

    Full Text Available Abstract Background Childhood asthma is common in Cape Town, a province of South Africa, but is underdiagnosed by general practitioners. Medications are often prescribed inappropriately, and care is episodic. The objective of this study is to assess the impact of educational outreach to general practitioners on asthma symptoms of children in their practice. Methods This is a cluster randomised trial with general practices as the unit of intervention, randomisation, and analysis. The setting is Mitchells Plain (population 300,000, a dormitory town near Cape Town. Solo general practitioners, without nurse support, operate from storefront practices. Caregiver-reported symptom data were collected for 318 eligible children (2 to 17 years with moderate to severe asthma, who were attending general practitioners in Mitchells Plain. One year post-intervention follow-up data were collected for 271 (85% of these children in all 43 practices. Practices randomised to intervention (21 received two 30-minute educational outreach visits by a trained pharmacist who left materials describing key interventions to improve asthma care. Intervention and control practices received the national childhood asthma guideline. Asthma severity was measured in a parent-completed survey administered through schools using a symptom frequency and severity scale. We compared intervention and control group children on the change in score from pre-to one-year post-intervention. Results Symptom scores declined an additional 0.84 points in the intervention vs. control group (on a nine-point scale. p = 0.03. For every 12 children with asthma exposed to a doctor allocated to the intervention, one extra child will have substantially reduced symptoms. Conclusion Educational outreach was accepted by general practitioners and was effective. It could be applied to other health care quality problems in this setting.

  4. 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

  5. A 10-Week Multimodal Nutrition Education Intervention Improves Dietary Intake among University Students: Cluster Randomised Controlled Trial

    OpenAIRE

    Mohd Razif Shahril; Wan Putri Elena Wan Dali; Pei Lin Lua

    2013-01-01

    The aim of the study was to evaluate the effectiveness of implementing multimodal nutrition education intervention (NEI) to improve dietary intake among university students. The design of study used was cluster randomised controlled design at four public universities in East Coast of Malaysia. A total of 417 university students participated in the study. They were randomly selected and assigned into two arms, that is, intervention group (IG) or control group (CG) according to their cluster. T...

  6. Effectiveness of a hospital-based work support intervention for female cancer patients - a multi-centre randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Sietske J Tamminga

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

  7. Enhancing relationship functioning during the transition to parenthood: a cluster-randomised controlled trial.

    Science.gov (United States)

    Daley-McCoy, Cathyrn; Rogers, Maeve; Slade, Pauline

    2015-10-01

    This randomised controlled trial examined the feasibility of enhancing relationship functioning in couples during the transition to parenthood through the development and delivery of a low-intensity antenatal intervention. The 2-h psycho-educational programme marks the first of its kind to be trialled in the UK and was delivered as an adjunct to existing antenatal classes provided through the National Health Service. A cluster randomised design was used as antenatal classes rather than participants were randomly allocated to either treatment condition. Feasibility was assessed on the basis of pragmatic delivery and acceptability of the intervention. Data from 47 participants who received the intervention and 36 participants who did not was then compared to provide a preliminary indication of its effectiveness. Outcomes were assessed in terms of relationship satisfaction, couple communication and psychological distress. The intervention appeared feasible in terms of pragmatic delivery, rates of uptake and attendance at sessions. Participant evaluation forms also indicated that people were reasonably satisfied with the intervention and would recommend it to friends. Three significant phases × condition interactions were indicated using mixed-methods analyses of variance (ANOVAs); women in the intervention condition reported significantly less deterioration in relationship satisfaction (F(1, 44) = 3.11; p = 0.021; eta(2) = 0.07), while men in the intervention condition reported significantly less deterioration in couple communication (F(1, 35) = 2.59; p = 0.029; eta(2) = 0.08) and significant improvement in their experience of psychological distress (adjusted z = 1.99; p = 0.023; Cohen's d = 0.47). These positive preliminary indicators lend support to future large-scale investigation. PMID:25663309

  8. Effectiveness of a stepped primary care smoking cessation intervention (ISTAPS study: design of a cluster randomised trial

    Directory of Open Access Journals (Sweden)

    Zarza Elvira

    2009-02-01

    Full Text Available Abstract Background There is a considerable body of evidence on the effectiveness of specific interventions in individuals who wish to quit smoking. However, there are no large-scale studies testing the whole range of interventions currently recommended for helping people to give up smoking; specifically those interventions that include motivational interviews for individuals who are not interested in quitting smoking in the immediate to short term. Furthermore, many of the published studies were undertaken in specialized units or by a small group of motivated primary care centres. The objective of the study is to evaluate the effectiveness of a stepped smoking cessation intervention based on a trans-theoretical model of change, applied to an extensive group of Primary Care Centres (PCC. Methods/Design Cluster randomised clinical trial. Unit of randomization: basic unit of care consisting of a family physician and a nurse, both of whom care for the same population (aprox. 2000 people. Intention to treat analysis. Study population: Smokers (n = 3024 aged 14 to 75 years consulting for any reason to PCC and who provided written informed consent to participate in the trial. Intervention: 6-month implementation of recommendations of a Clinical Practice Guideline which includes brief motivational interviews for smokers at the precontemplation – contemplation stage, brief intervention for smokers in preparation-action who do not want help, intensive intervention with pharmacotherapy for smokers in preparation-action who want help, and reinforcing intervention in the maintenance stage. Control group: usual care. Outcome measures: Self-reported abstinence confirmed by exhaled air carbon monoxide concentration of ≤ 10 parts per million. Points of assessment: end of intervention period and 1 and 2 years post-intervention; continuous abstinence rate for 1 year; change in smoking cessation stage; health status measured by SF-36. Discussion The

  9. Effectiveness of Electronic Reminders to Improve Medication Adherence in Tuberculosis Patients: A Cluster-Randomised Trial.

    Directory of Open Access Journals (Sweden)

    Xiaoqiu Liu

    2015-09-01

    Full Text Available Mobile text messaging and medication monitors (medication monitor boxes have the potential to improve adherence to tuberculosis (TB treatment and reduce the need for directly observed treatment (DOT, but to our knowledge they have not been properly evaluated in TB patients. We assessed the effectiveness of text messaging and medication monitors to improve medication adherence in TB patients.In a pragmatic cluster-randomised trial, 36 districts/counties (each with at least 300 active pulmonary TB patients registered in 2009 within the provinces of Heilongjiang, Jiangsu, Hunan, and Chongqing, China, were randomised using stratification and restriction to one of four case-management approaches in which patients received reminders via text messages, a medication monitor, combined, or neither (control. Patients in the intervention arms received reminders to take their drugs and reminders for monthly follow-up visits, and the managing doctor was recommended to switch patients with adherence problems to more intensive management or DOT. In all arms, patients took medications out of a medication monitor box, which recorded when the box was opened, but the box gave reminders only in the medication monitor and combined arms. Patients were followed up for 6 mo. The primary endpoint was the percentage of patient-months on TB treatment where at least 20% of doses were missed as measured by pill count and failure to open the medication monitor box. Secondary endpoints included additional adherence and standard treatment outcome measures. Interventions were not masked to study staff and patients. From 1 June 2011 to 7 March 2012, 4,292 new pulmonary TB patients were enrolled across the 36 clusters. A total of 119 patients (by arm: 33 control, 33 text messaging, 23 medication monitor, 30 combined withdrew from the study in the first month because they were reassessed as not having TB by their managing doctor (61 patients or were switched to a different

  10. Children and youth perceive smoking messages in an unbranded advertisement from a NIKE marketing campaign: a cluster randomised controlled trial

    OpenAIRE

    Daniel Mark; Auger Nathalie; Knäuper Bärbel; Raynault Marie-France; Pless Barry

    2011-01-01

    Abstract Background How youth perceive marketing messages in sports is poorly understood. We evaluated whether youth perceive that the imagery of a specific sports marketing advertisement contained smoking-related messages. Methods Twenty grade 7 to 11 classes (397 students) from two high schools in Montréal, Canada were recruited to participate in a cluster randomised single-blind controlled trial. Classes were randomly allocated to either a NIKE advertisement containing the phrase 'LIGHT IT...

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

    OpenAIRE

    Arvanitis Theodoros N; Emparanza Jose I; Nagy Eva; Horvath Andrea R; Decsi Tamas; Meyerrose Berrit; Weinbrenner Susanne; Das Kausik; Malick Sadia; Hadley Julie; Zamora Javier; Coppus Sjors FPJ; Kulier Regina; Burls Amanda; Cabello Juan B

    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 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 cl...

  12. Free healthy breakfasts in primary schools: A cluster randomised controlled trial of a policy intervention in Wales, UK

    OpenAIRE

    Murphy, S.; Moore, G.; Tapper, K.; Lynch, R; Clarke, R.; Raisanen, L.; DeSousa, C; Moore, L.

    2011-01-01

    Objective: The present study evaluated the impact of a national school programme of universal free healthy breakfast provision in Wales, UK. Design: A cluster randomised controlled trial with repeated cross-sectional design and a 12-month follow-up. Primary outcomes were breakfast skipping, breakfast diet and episodic memory. Secondary outcomes were frequency of eating breakfast at home and at school, breakfast attitudes, rest-of-day diet and class behaviour. Setting: Primary schools ...

  13. Effects of Dementia-Care Mapping on Residents and Staff of Care Homes: A Pragmatic Cluster-Randomised Controlled Trial

    OpenAIRE

    Geertje van de Ven; Irena Draskovic; Eddy M M Adang; Rogier Donders; Zuidema, Sytse U.; Koopmans, Raymond T C M; Vernooij-Dassen, Myrra J. F. J.

    2013-01-01

    BACKGROUND: The effectiveness of dementia-care mapping (DCM) for institutionalised people with dementia has been demonstrated in an explanatory cluster-randomised controlled trial (cRCT) with two DCM researchers carrying out the DCM intervention. In order to be able to inform daily practice, we studied DCM effectiveness in a pragmatic cRCT involving a wide range of care homes with trained nursing staff carrying out the intervention. METHODS: Dementia special care units were randomly assigned ...

  14. Effect of combining mosquito repellent and insecticide treated net on malaria prevalence in Southern Ethiopia: a cluster-randomised trial

    OpenAIRE

    Deressa, Wakgari; Yihdego, Yemane Y; Kebede, Zelalem; Batisso, Esey; Tekalegne, Agonafer; Dagne, Getachew A.

    2014-01-01

    Background A mosquito repellent has the potential to prevent malaria infection, but there has been few studies demonstrating the effectiveness of combining this strategy with the highly effective long-lasting insecticidal nets (LLINs). This study aimed to determine the effect of combining community-based mosquito repellent with LLINs in the reduction of malaria. Methods A community-based clustered-randomised trial was conducted in 16 rural villages with 1,235 households in southern Ethiopia b...

  15. Support and Assessment for Fall Emergency Referrals (SAFER 1): Cluster Randomised Trial of Computerised Clinical Decision Support for Paramedics

    OpenAIRE

    Helen Anne Snooks; Ben Carter; Jeremy Dale; Theresa Foster; Ioan Humphreys; Philippa Anne Logan; Ronan Anthony Lyons; Suzanne Margaret Mason; Ceri James Phillips; Antonio Sanchez; Mushtaq Wani; Alan Watkins; Bridget Elizabeth Wells; Richard Whitfield; Ian Trevor Russell

    2014-01-01

    Objective To evaluate effectiveness, safety and cost-effectiveness of Computerised Clinical Decision Support (CCDS) for paramedics attending older people who fall. Design Cluster trial randomised by paramedic; modelling. Setting 13 ambulance stations in two UK emergency ambulance services. Participants 42 of 409 eligible paramedics, who attended 779 older patients for a reported fall. Interventions Intervention paramedics received CCDS on Tablet computers to guide patient care. Control parame...

  16. Early intervention for adolescents with Patellofemoral Pain Syndrome - a pragmatic cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Rathleff Michael S

    2012-01-01

    Full Text Available Abstract 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

  17. Implementing referral guidelines: lessons from a negative outcome cluster randomised factorial trial in general practice

    Directory of Open Access Journals (Sweden)

    Shaw Lindsey

    2006-11-01

    Full Text Available Abstract Background Few patients with lower bowel symptoms who consult their general practitioner need a specialist opinion. However data from referred patients suggest that those who are referred would benefit from detailed assessment before referral. Methods A cluster randomised factorial trial. 44 general practices in North Trent, UK. Practices were offered either an electronic interactive referral pro forma, an educational outreach visit by a local colorectal surgeon, both or neither. The main outcome measure was the proportion of cases with severe diverticular disease, cancer or precancerous lesions and inflammatory bowel disease in those referred by each group. A secondary outcome was a referral letter quality score. Semi-structured interviews were conducted to identify key themes relating to the use of the software Results From 150 invitations, 44 practices were recruited with a total list size of 265,707. There were 716 consecutive referrals recorded over a six-month period, for which a diagnosis was available for 514. In the combined software arms 14% (37/261 had significant pathology, compared with 19% (49/253 in the non-software arms, relative risk 0.73 (95% CI: 0.46 to 1.15. In the combined educational outreach arms 15% (38/258 had significant pathology compared with 19% (48/256 in the non-educational arms, relative risk 0.79 (95% CI: 0.50 to 1.24. Pro forma practices documented better assessment of patients at referral. Conclusion There was a lack of evidence that either intervention increased the proportion of patients with organic pathology among those referred. The interactive software did improve the amount of information relayed in referral letters although we were unable to confirm if this made a significant difference to patients or their health care providers. The potential value of either intervention may have been diminished by their limited uptake within the context of a cluster randomised clinical trial. A number of

  18. A pragmatic multi-centred randomised controlled trial of yoga for chronic low back pain: Trial protocol

    OpenAIRE

    Cox, Helen; Tilbrook, Helen; Aplin, John; Chuang, Ling-Hsiang; Hewitt, Catherine; Jayakody, Shalmini; Semlyen, Anna; Soares, Marta O; Torgerson, David; Trewhela, Alison; Watt, Ian; Worthy, Gill

    2010-01-01

    A systematic review revealed three small randomised controlled trials of yoga for low back pain, all of which showed effects on back pain that favoured the yoga group. To build on these studies a larger trial, with longer term follow-up, and a number of different yoga teachers delivering the intervention is required. This study protocol describes the details of a randomised controlled trial (RCT) to determine the effectiveness and cost-effectiveness of Yoga for chronic Low Back Pain, which is...

  19. The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder - study protocol of the randomised, multi-centre controlled SOSTA - net trial

    OpenAIRE

    Freitag Christine M; Cholemkery Hannah; Elsuni Leyla; Kroeger Anne K; Bender Stephan; Kunz Cornelia Ursula; Kieser Meinhard

    2013-01-01

    Abstract Background Group-based social skills training (SST) has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD). To date, no sufficiently powered randomised controlled trial has been performed to establish efficacy and safety of SST in children and adolescents with HFASD. In this randomised, multi-centre, controlled trial with 220 children and adolescents with HFASD it is hypothesized, that add-on group-based SST using the 12 weeks manu...

  20. Protocol for economic evaluation alongside the IMPLEMENT cluster randomised controlled trial

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    McKenzie Joanne E

    2008-02-01

    Full Text Available Abstract Background The recent development and publication of evidence-based clinical practice guidelines (CPGs for acute low back pain (LBP has resulted in evidence-based recommendations that, if implemented, have the potential to improve the quality and safety of care for acute LBP. While a strategy has been specified for dissemination of the CPG for acute LBP in Australia, there is no accompanying plan for active implementation. Evidence regarding the cost-effectiveness of active implementation of CPGs for acute LBP is sparse. The IMPLEMENT study will consider the incremental benefits and costs of progressing beyond development and dissemination to implementation. Methods/design Cost-effectiveness and cost-utility analyses alongside the IMPLEMENT cluster randomised controlled trial (CRCT from a societal perspective to quantify the additional costs (savings and health gains associated with a targeted implementation strategy as compared with access to the CPG via dissemination only. Discussion The protocol provided here registers our intent to conduct an economic evaluation alongside the IMPLEMENT study, facilitates peer-review of proposed methods and provides a transparent statement of planned analyses. Trial registration Australian New Zealand Clinical Trials Registry ACTRN012606000098538

  1. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856

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    Krämer Jürgen

    2004-03-01

    Full Text Available Abstract Background Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. Methods 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third conservative standard therapy. The trial protocol is described with eligibility criteria, detailed information on the treatment definition, blinding, endpoints, safety evaluation, statistical methods, sample size determination, monitoring, legal aspects, and the current status of the trial. Discussion A critical discussion is given regarding the considerations about standardisation of the acupuncture treatment, the choice of the control group, and the blinding of patients and observers.

  2. A cluster randomised controlled effectiveness trial evaluating perinatal home visiting among South African mothers/infants.

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    Mary Jane Rotheram-Borus

    Full Text Available Interventions are needed to reduce poor perinatal health. We trained community health workers (CHWs as home visitors to address maternal/infant risks.In a cluster randomised controlled trial in Cape Town townships, neighbourhoods were randomised within matched pairs to 1 the control, healthcare at clinics (n = 12 neighbourhoods; n = 594 women, or 2 a home visiting intervention by CBW trained in cognitive-behavioural strategies to address health risks (by the Philani Maternal, Child Health and Nutrition Programme, in addition to clinic care (n = 12 neighbourhoods; n = 644 women. Participants were assessed during pregnancy (2% refusal and 92% were reassessed at two weeks post-birth, 88% at six months and 84% at 18 months later. We analysed 32 measures of maternal/infant well-being over the 18 month follow-up period using longitudinal random effects regressions. A binomial test for correlated outcomes evaluated overall effectiveness over time. The 18 month post-birth assessment outcomes also were examined alone and as a function of the number of home visits received.Benefits were found on 7 of 32 measures of outcomes, resulting in significant overall benefits for the intervention compared to the control when using the binomial test (p = 0.008; nevertheless, no effects were observed when only the 18 month outcomes were analyzed. Benefits on individual outcomes were related to the number of home visits received. Among women living with HIV, intervention mothers were more likely to implement the PMTCT regimens, use condoms during all sexual episodes (OR = 1.25; p = 0.014, have infants with healthy weight-for-age measurements (OR = 1.42; p = 0.045, height-for-age measurements (OR = 1.13, p<0.001, breastfeed exclusively for six months (OR = 3.59; p<0.001, and breastfeed longer (OR = 3.08; p<0.001. Number of visits was positively associated with infant birth weight ≥2500 grams (OR = 1.07; p = 0

  3. Preoperative airway assessment - experience gained from a multicentre cluster randomised trial and the Danish Anaesthesia Database.

    Science.gov (United States)

    Nørskov, Anders Kehlet

    2016-05-01

    Difficulties with airway management in relation to general anaesthesia have been a challenge for the anaesthesiologist since the birth of anaesthesia. Massive landmark improvements have been made and general anaesthesia is now regarded as a safe procedure. However, rare, difficult airway management still occurs and it prompts increased risk of morbidity and mortality - especially when not anticipated. Several preoperative risk factors for airway difficulties have been identified, yet none have convincing diagnostic accuracy as stand alone tests. Combining several risk factors increase the predictive value of the test and multivariable risk models have been developed. The Simplified Airway Risk Index (SARI) is a predictive model developed for anticipation of a difficult direct laryngoscopy. However, neither the diagnostic accuracy of the SARI nor of any other model has been tested prospectively and compared with existing practice for airway assessment in a randomised trial setting. The first objective of this thesis was to quantify the proportion of unanticipated difficult intubation and difficult mask ventilation in Denmark. The second objective was to design a cluster randomised trial, using state of the art methodology, in order to test the clinical impact of using the SARI for preoperative airway assessment compared with a clinical judgement based on usual practice for airway assessment. Finally, to test if implementation of the SARI would reduce the proportion of unanticipated difficult intubation compared with usual care for airway assessment. This thesis is based on data from the Danish Anaesthesia Database (DAD). Paper 1 presents an observational cohort study on 188,064 patients who underwent tracheal intubation from 2008 to 2011. Data on the anaesthesiologists' preoperative anticipations of airway difficulties was compared with actual airway management conditions, thus enabling an estimation of the proportion of unanticipated difficulties with intubation

  4. Globular cluster systems in low-luminosity early-type galaxies near the Fornax Cluster centre

    CERN Document Server

    Bassino, L P; Dirsch, B; Bassino, Lilia P.; Richtler, Tom; Dirsch, Boris

    2006-01-01

    We present a photometric study of the globular cluster systems of the Fornax cluster galaxies NGC 1374, NGC 1379, and NGC 1387. The data consists of images from the wide-field MOSAIC Imager of the CTIO 4-m telescope, obtained with Washington C and Kron-Cousins R filters. The images cover a field of 36 x 36 arcmin, corresponding to 200 x 200 kpc at the Fornax distance. Two of the galaxies, NGC 1374 and NGC 1379, are low-luminosity ellipticals while NGC 1387 is a low-luminosity lenticular. Their cluster systems are still embedded in the cluster system of NGC 1399. Therefore the use of a large field is crucial and some differences to previous work can be explained by this. The colour distributions of all globular cluster systems are bimodal. NGC 1387 presents a particularly distinct separation between red and blue clusters and an overproportionally large population of red clusters. The radial distribution is different for blue and red clusters, red clusters being more concentrated towards the respective galaxies...

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

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    Anthony Shakeshaft

    2014-03-01

    Full Text Available BACKGROUND: 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. METHODS AND FINDINGS: 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

  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.; Anstey, Kaarin J.; Sherrington, Catherine; Lord, Stephen R.; Cumming, Robert G.

    2016-01-01

    Background 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. Methods and Findings 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. Main outcomes: falls during the 12 mo trial and Trail Making Tests. Secondary outcomes: 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

  7. 'Be active, eat right', evaluation of an overweight prevention protocol among 5-year-old children: design of a cluster randomised controlled trial

    OpenAIRE

    Veldhuis Lydian; Struijk Mirjam K; Kroeze Willemieke; Oenema Anke; Renders Carry M; Bulk-Bunschoten Anneke MW; HiraSing Remy A; Raat Hein

    2009-01-01

    Abstract Background The prevalence of overweight and obesity in children has at least doubled in the past 25 years with a major impact on health. In 2005 a prevention protocol was developed applicable within Youth Health Care. This study aims to assess the effects of this protocol on prevalence of overweight and health behaviour among children. Methods and design A cluster randomised controlled trial is conducted among 5-year-old children included by 44 Youth Health Care teams randomised with...

  8. The GRAIDS Trial: a cluster randomised controlled trial of computer decision support for the management of familial cancer risk in primary care

    OpenAIRE

    Emery, J.; Morris, H.; R. Goodchild; Fanshawe, T.; Prevost, A.T.; Bobrow, M.; Kinmonth, A L

    2007-01-01

    The objective was to evaluate the effect of an assessment strategy using the computer decision support system (the GRAIDS software), on the management of familial cancer risk in British general practice in comparison with best current practice. The design included cluster randomised controlled trial, and involved forty-five general practice teams in East Anglia, UK. Randomised to GRAIDS (Genetic Risk Assessment on the Internet with Decision Support) support (intervention n=23) or comparison (...

  9. Tele-guidance of chronic heart failure patients enhances knowledge about the disease. A multi-centre, randomised controlled study

    NARCIS (Netherlands)

    Balk, A.H.; Davidse, W.; Dommelen, P. van; Klaassen, E.; Caliskan, K.; Burgh, P. van der; Leenders, C.M.

    2008-01-01

    Background: New strategies are required to optimize care in increasing numbers of chronic heart failure patients. The aim of this randomised trial was to evaluate a remote guidance system. Methods: Intervention group patients received a home TV-channel providing educational materials. Tele-guidance

  10. Investigating the effects of 6 months extended duration, in-centre nocturnal versus conventional haemodialysis treatment: a non-randomised, controlled feasibility study

    Science.gov (United States)

    Graham-Brown, Matthew P M; Preston, Robert; Pickering, Warren; McCann, Gerry P

    2016-01-01

    Introduction In-centre nocturnal haemodialysis (INHD) is an underutilised dialysis regimen that can potentially provide patients with better clinical outcomes due to extended treatment times. We have established an INHD programme within our clinical network, fulfilling a previously unmet patient need. This feasibility study aims to gather sufficient data on numerous outcome measures to inform the design of a multicentre randomised controlled trial that will establish the potential benefits of INHD and increase the availability of this service nationally and internationally. Methods and analysis This will be a non-randomised controlled study. Prevalent patients on haemodialysis (HD) will electively change from a conventional in-centre HD regimen of 4 hours thrice weekly to a regimen of extended treatment times (5–8 hours) delivered in-centre overnight thrice weekly. After recruitment of the INHD cohort, a group of patients matched for age, gender and dialysis vintage will be selected from patients remaining on a conventional daytime dialysis programme. Outcome measures will include left ventricular mass as measured by MRI, physical performance measured by the short physical performance battery and physical activity measured by accelerometry. Additionally we will measure quality of life using validated questionnaires, nutritional status by bioimpedance spectroscopy and food diaries, and blood sampling for markers of cardiovascular disease, systemic inflammation. Suitable statistical tests shall be used to analyse the data. We will use omnibus tests to observe changes over the duration of the intervention and between groups. We will also look for associations between outcome measures that may warrant further investigation. These data will be used to inform the power calculation for future studies. Ethics and dissemination A favourable opinion was granted by Northampton Research Ethics Committee (15/EM/0268). It is anticipated that results of this study will be

  11. A novel school-based intervention to improve nutrition knowledge in children: cluster randomised controlled trial

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    Ong Ken K

    2010-03-01

    Full Text Available Abstract Background Improving nutrition knowledge among children may help them to make healthier food choices. The aim of this study was to assess the effectiveness and acceptability of a novel educational intervention to increase nutrition knowledge among primary school children. Methods We developed a card game 'Top Grub' and a 'healthy eating' curriculum for use in primary schools. Thirty-eight state primary schools comprising 2519 children in years 5 and 6 (aged 9-11 years were recruited in a pragmatic cluster randomised controlled trial. The main outcome measures were change in nutrition knowledge scores, attitudes to healthy eating and acceptability of the intervention by children and teachers. Results Twelve intervention and 13 control schools (comprising 1133 children completed the trial. The main reason for non-completion was time pressure of the school curriculum. Mean total nutrition knowledge score increased by 1.1 in intervention (baseline to follow-up: 28.3 to 29.2 and 0.3 in control schools (27.3 to 27.6. Total nutrition knowledge score at follow-up, adjusted for baseline score, deprivation, and school size, was higher in intervention than in control schools (mean difference = 1.1; 95% CI: 0.05 to 2.16; p = 0.042. At follow-up, more children in the intervention schools said they 'are currently eating a healthy diet' (39.6% or 'would try to eat a healthy diet' (35.7% than in control schools (34.4% and 31.7% respectively; chi-square test p Conclusions The 'Top Grub' card game facilitated the enjoyable delivery of nutrition education in a sample of UK primary school age children. Further studies should determine whether improvements in nutrition knowledge are sustained and lead to changes in dietary behaviour.

  12. Ask: a health advocacy program for adolescents with an intellectual disability: a cluster randomised controlled trial

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    Lennox Nicholas

    2012-09-01

    Full Text Available Abstract Background Adolescents with intellectual disability often have poor health and healthcare. This is partly as a consequence of poor communication and recall difficulties, and the possible loss of specialised paediatric services. Methods/Design A cluster randomised trial was conducted with adolescents with intellectual disability to investigate a health intervention package to enhance interactions among adolescents with intellectual disability, their parents/carers, and general practitioners (GPs. The trial took place in Queensland, Australia, between February 2007 and September 2010. The intervention package was designed to improve communication with health professionals and families’ organisation of health information, and to increase clinical activities beneficial to improved health outcomes. It consisted of the Comprehensive Health Assessment Program (CHAP, a one-off health check, and the Ask Health Diary, designed for on-going use. Participants were drawn from Special Education Schools and Special Education Units. The education component of the intervention was delivered as part of the school curriculum. Educators were surveyed at baseline and followed-up four months later. Carers were surveyed at baseline and after 26 months. Evidence of health promotion, disease prevention and case-finding activities were extracted from GPs clinical records. Qualitative interviews of educators occurred after completion of the educational component of the intervention and with adolescents and carers after the CHAP. Discussion Adolescents with intellectual disability have difficulty obtaining many health services and often find it difficult to become empowered to improve and protect their health. The health intervention package proposed may aid them by augmenting communication, improving documentation of health encounters, and improving access to, and quality of, GP care. Recruitment strategies to consider for future studies in this population

  13. Evaluation of benefit to patients of training mental health professionals in suicide guidelines: cluster randomised trial.

    OpenAIRE

    Beurs, D.P. de; Groot, M.H. de; Keijser, J. de; Duijn, E. van; Winter, R.F.P. de; Kerkhof, A.J.F.M.

    2015-01-01

    Background: Randomised studies examining the effect on patients of training professionals in adherence to suicide guidelines are scarce. Aims: To assess whether patients benefited from the training of professionals in adherence to suicide guidelines. Method: In total 45 psychiatric departments were randomised (Dutch trial register: NTR3092). In the intervention condition, all staff in the departments were trained with an e-learning supported train-the-trainer programme. After the intervention...

  14. Reducing unnecessary hospital days to improve quality of care through physician accountability: a cluster randomised trial

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    Caminiti Caterina

    2013-01-01

    Full Text Available Abstract Background Over 20% of hospital bed use is inappropriate, implying a waste of resources and the increase of patient iatrogenic risk. Methods This is a cluster, pragmatic, randomised controlled trial, carried out in a large University Hospital of Northern Italy, aiming to evaluate the effect of a strategy to reduce unnecessary hospital days. The primary outcome was the percentage of patient-days compatible with discharge. Among secondary objectives, to describe the strategy’s effect in the long-term, as well as on hospital readmissions, considered to be a marker of the quality of hospital care. The 12 medical wards with the longest length of stay participated. Effectiveness was measured at the individual level on 3498 eligible patients during monthly index days. Patients admitted or discharged on index days, or with stay >90 days, were excluded. All ward staff was blinded to the index days, while staff in the control arm and data analysts were blinded to the trial’s objectives and interventions. The strategy comprised the distribution to physicians of the list of their patients whose hospital stay was compatible with discharge according to a validated Delay Tool, and of physician length of stay profiles, followed by audits managed autonomously by the physicians of the ward. Results During the 12 months of data collection, over 50% of patient-days were judged to be compatible with discharge. Delays were mainly due to problems with activities under medical staff control. Multivariate analysis considering clustering showed that the strategy reduced patient-days compatible with discharge by 16% in the intervention vs control group, (OR=0.841; 95% CI, 0.735 to 0.963; P=0.012. Follow-up at 1 year did not yield a statistically significant difference between the percentages of patient-days judged to be compatible with discharge between the two arms (OR=0.818; 95% CI, 0.476 to 1.405; P=0.47. There was no significant difference in 30-day

  15. Design and performance of a multi-centre randomised controlled trial and economic evaluation of joint tele-consultations [ISRCTN54264250

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    Thompson Simon

    2002-01-01

    Full Text Available Abstract Background Appropriate information flow is crucial to the care of patients, particularly at the interface between primary and secondary care. Communication problems can result from inadequate organisation and training, There is a major expectation that information and communication technologies may offer solutions, but little reliable evidence. This paper reports the design and performance of a multi-centre randomised controlled trial (RCT, unparalleled in telemedicine research in either scale or range of outcomes. The study investigated the effectiveness and cost implications in rural and inner-city settings of using videoconferencing to perform joint tele-consultations as an alternative to general practitioner referral to the hospital specialist in the outpatient clinic. Methods Joint tele-consultation services were established in both the Royal Free Hampstead NHS Trust in inner London, and the Royal Shrewsbury Hospitals Trust, in Shropshire. All the patients who gave consent to participate were randomised either to joint tele-consultation or to a routine outpatients appointment. The principal outcome measures included the frequency of decision by the specialist to offer a follow-up outpatient appointment, patient satisfaction (Ware Specific Questionnaire, wellbeing (SF12 and enablement (PEI, numbers of tests, investigations, procedures and treatments. Results A total of 134 general practitioners operating from 29 practices participated in the trial, referring a total of 3170 patients to 20 specialists in ENT medicine, general medicine (including endocrinology, and rheumatology, gastroenterology, orthopaedics, neurology and urology. Of these, 2094 patients consented to participate in the study and were correctly randomised. There was a 91% response rate to the initial assessment questionnaires, and analysis showed equivalence for all key characteristics between the treatment and control groups. Conclusion We have designed and

  16. A multifaceted workplace intervention for low back pain in nurses' aides: a pragmatic stepped wedge cluster randomised controlled trial.

    Science.gov (United States)

    Rasmussen, Charlotte Diana Nørregaard; Holtermann, Andreas; Bay, Hans; Søgaard, Karen; Birk Jørgensen, Marie

    2015-09-01

    This study established the effectiveness of a workplace multifaceted intervention consisting of participatory ergonomics, physical training, and cognitive-behavioural training (CBT) for low back pain (LBP). Between November 2012 and May 2014, we conducted a pragmatic stepped wedge cluster randomised controlled trial with 594 workers from eldercare workplaces (nursing homes and home care) randomised to 4 successive time periods, 3 months apart. The intervention lasted 12 weeks and consisted of 19 sessions in total (physical training [12 sessions], CBT [2 sessions], and participatory ergonomics [5 sessions]). Low back pain was the outcome and was measured as days, intensity (worst pain on a 0-10 numeric rank scale), and bothersomeness (days) by monthly text messages. Linear mixed models were used to estimate the intervention effect. Analyses were performed according to intention to treat, including all eligible randomised participants, and were adjusted for baseline values of the outcome. The linear mixed models yielded significant effects on LBP days of -0.8 (95% confidence interval [CI], -1.19 to -0.38), LBP intensity of -0.4 (95% CI, -0.60 to -0.26), and bothersomeness days of -0.5 (95% CI, -0.85 to -0.13) after the intervention compared with the control group. This study shows that a multifaceted intervention consisting of participatory ergonomics, physical training, and CBT can reduce LBP among workers in eldercare. Thus, multifaceted interventions may be relevant for improving LBP in a working population. PMID:25993549

  17. WHEDA study: effectiveness of occupational therapy at home for older people with dementia and their caregivers--the design of a pragmatic randomised controlled trial evaluating a Dutch programme in seven German centres.

    NARCIS (Netherlands)

    Voigt-Radloff, S.; Graff, M.J.L.; Leonhart, R.; Schornstein, K.; Vernooy-Dassen, M.J.F.J.; Olde Rikkert, M.G.M.; Huell, M.

    2009-01-01

    BACKGROUND: A recent Dutch mono-centre randomised controlled trial has shown that occupational therapy improves daily functioning in dementia. The aim of this present study is to compare the effects of the Dutch community occupational therapy programme with a community occupational therapy consultat

  18. Effect of the daily consumption of protein enriched bread and protein enriched drinking yoghurt on the total protein intake in older adults in a rehabilitation centre: a single blind randomised controlled trial

    NARCIS (Netherlands)

    Til, van A.J.; Naumann, E.; Cox-Claessens, I.J.H.M.; Kremer, S.; Boelsma, E.; Schueren, van der D.E.

    2014-01-01

    Objectives To investigate the effects of protein enriched bread and drinking yoghurt, substituting regular products, on the total protein intake and the distribution of protein intake over the day in older adults. Design A single blind randomised controlled trial. Setting Rehabilitation centre. Part

  19. Changes in body weight and food choice in those attempting smoking cessation: a cluster randomised controlled trial

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    Leslie Wilma S

    2012-05-01

    Full Text Available Abstract Background Fear of weight gain is a barrier to smoking cessation and significant cause of relapse for many people. The provision of nutritional advice as part of a smoking cessation programme may assist some in smoking cessation and perhaps limit weight gain. The aim of this study was to determine the effect of a structured programme of dietary advice on weight change and food choice, in adults attempting smoking cessation. Methods Cluster randomised controlled design. Classes randomised to intervention commenced a 24-week intervention, focussed on improving food choice and minimising weight gain. Classes randomised to control received “usual care”. Results Twenty-seven classes in Greater Glasgow were randomised between January and August 2008. Analysis, including those who continued to smoke, showed that actual weight gain and percentage weight gain was similar in both groups. Examination of data for those successful at giving up smoking showed greater mean weight gain in intervention subjects (3.9 (SD 3.1 vs. 2.7 (SD 3.7 kg. Between group differences were not significant (p = 0.23, 95% CI −0.9 to 3.5. In comparison to baseline improved consumption of fruit and vegetables and breakfast cereal were reported in the intervention group. A higher percentage of control participants continued smoking (74% vs. 66%. Conclusions The intervention was not successful at minimising weight gain in comparison to control but was successful in facilitating some sustained improvements in the dietary habits of intervention participants. Improved quit rates in the intervention group suggest that continued contact with advisors may have reduced anxieties regarding weight gain and encouraged cessation despite weight gain. Research should continue in this area as evidence suggests that the negative effects of obesity could outweigh the health benefits achieved through reductions in smoking prevalence. Trial registration Current Controlled Trials

  20. Hand sanitiser provision for reducing illness absences in primary school children: a cluster randomised trial.

    Directory of Open Access Journals (Sweden)

    Patricia Priest

    2014-08-01

    Full Text Available BACKGROUND: The potential for transmission of infectious diseases offered by the school environment are likely to be an important contributor to the rates of infectious disease experienced by children. This study aimed to test whether the addition of hand sanitiser in primary school classrooms compared with usual hand hygiene would reduce illness absences in primary school children in New Zealand. METHODS AND FINDINGS: This parallel-group cluster randomised trial took place in 68 primary schools, where schools were allocated using restricted randomisation (1:1 ratio to the intervention or control group. All children (aged 5 to 11 y in attendance at participating schools received an in-class hand hygiene education session. Schools in the intervention group were provided with alcohol-based hand sanitiser dispensers in classrooms for the winter school terms (27 April to 25 September 2009. Control schools received only the hand hygiene education session. The primary outcome was the number of absence episodes due to any illness among 2,443 follow-up children whose caregivers were telephoned after each absence from school. Secondary outcomes measured among follow-up children were the number of absence episodes due to specific illness (respiratory or gastrointestinal, length of illness and illness absence episodes, and number of episodes where at least one other member of the household became ill subsequently (child or adult. We also examined whether provision of sanitiser was associated with experience of a skin reaction. The number of absences for any reason and the length of the absence episode were measured in all primary school children enrolled at the schools. Children, school administrative staff, and the school liaison research assistants were not blind to group allocation. Outcome assessors of follow-up children were blind to group allocation. Of the 1,301 and 1,142 follow-up children in the hand sanitiser and control groups, respectively, the

  1. Formation Mechanism and Binding Energy for Body-Centred Regular Octahedral Structure of Li7 Cluster

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    The formation mechanism for the body-centred regular octahedral structure of Lh cluster is proposed. The curve of the total energy versus the separation R between the nucleus at tie centre and nuclei at the apexes for this structure of Lh has been calculated by using the method of Gou's modified arrangement channel quantum mechanics (MACQM). The result shows that the curve has a minimal energy of-52.169 73 a.u. at R= 5.06a0. When R approaches infinity, the totai energy of seven lithium atoms has the value of -51.996 21 a.u. So the binding energy of Lh with respect to seven lithium atoms is 0.173 52 a.u. Therefore the binding energy per atom for hit is 0.024 79 a.u. or 0.674 eV, which is greater than the binding energy per atom of 0.453 eV for Lii, the binding energy per atom of 0.494 eV for Liz and the binding energy per atom of 0.632 eV for Li& calculated previously by us. This means that the Lh cluster may be formed stably in a body-centred regular octahedral structure with a greater binding energy.

  2. Formation Mechanism and Binding Energy for Body-Centred Regular Icosahedral Structure of Li13 Cluster

    Institute of Scientific and Technical Information of China (English)

    LIU Wei-Na; LI Ping; GOU Qing-Quan; ZHAO Yan-Ping

    2008-01-01

    The formation mechanism for the body-centred regular icosahedral structure of Li13 cluster is proposed. The curve of the total energy versus the separation R between the nucleus at the centre and nuclei at the apexes for this structure of Li13 has been calculated by using the method of Gou's modified arrangement channel quantum mechanics (MACQM). The result shows that the curve has a minimal energy of-96.951 39 a.u. at R = 5.46a0. When R approaches to infinity, the total energy of thirteen lithium atoms has the value of-96.564 38 a.u. So the binding energy of Li13 with respect to thirteen lithium atoms is 0.387 01 a.u. Therefore the binding energy per atom for Li13 is 0.029 77 a.u. or 0.810 eV, which is greater than the binding energy per atom of 0.453 eV for Li2, 0.494 eV for Lia, 0.7878 eV for Li4, 0.632 eV for Lis, and 0.674 eV for Lit calculated by us previously. This means that the Li13 cluster may be formed stably in a body-centred regular icosahedral structure with a greater binding energy.

  3. Women's evaluation of abuse and violence care in general practice: a cluster randomised controlled trial (weave

    Directory of Open Access Journals (Sweden)

    Feder Gene

    2010-01-01

    Full Text Available Abstract Background Intimate partner abuse (IPA is a major public health problem with serious implications for the physical and psychosocial wellbeing of women, particularly women of child-bearing age. It is a common, hidden problem in general practice and has been under-researched in this setting. Opportunities for early intervention and support in primary care need to be investigated given the frequency of contact women have with general practice. Despite the high prevalence and health consequences of abuse, there is insufficient evidence for screening in primary care settings. Furthermore, there is little rigorous evidence to guide general practitioners (GPs in responding to women identified as experiencing partner abuse. This paper describes the design of a trial of a general practice-based intervention consisting of screening for fear of partner with feedback to GPs, training for GPs, brief counselling for women and minimal practice organisational change. It examines the effect on women's quality of life, mental health and safety behaviours. Methods/Design weave is a cluster randomised controlled trial involving 40 general practices in Victoria, Australia. Approximately 500 women (16-50 years seen by the GP in the previous year are mailed a short lifestyle survey containing an item to screen for IPA. Women who indicate that they were afraid of a partner/ex-partner in the last year and provide contact details are invited to participate. Once baseline data are collected, GPs are randomly assigned to either a group involving healthy relationship and responding to IPA training plus inviting women for up to 6 sessions of counselling or to a group involving basic education and usual care for women. Outcomes will be evaluated by postal survey at 6 and 12 months following delivery of the intervention. There will be an economic evaluation, and process evaluation involving interviews with women and GPs, to inform understanding about implementation

  4. Protocol for the ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation trial: a pragmatic multi-centre randomised controlled trial of surgical versus non-surgical treatment for proximal fracture of the humerus in adults

    Directory of Open Access Journals (Sweden)

    Maffulli Nicola

    2009-11-01

    Full Text Available Abstract Background Proximal humeral fractures, which occur mainly in older adults, account for approximately 4 to 5% of all fractures. Approximately 40% of these fractures are displaced fractures involving the surgical neck. Management of this group of fractures is often challenging and the outcome is frequently unsatisfactory. In particular it is not clear whether surgery gives better outcomes than non-surgical management. Currently there is much variation in the use of surgery and a lack of good quality evidence to inform this decision. Methods/Design We aim to undertake a pragmatic UK-based multi-centre randomised controlled trial evaluating the effectiveness and cost-effectiveness of surgical versus standard non-surgical treatment for adults with an acute closed displaced fracture of the proximal humerus with involvement of the surgical neck. The choice of surgical intervention is left to the surgeon, who must use techniques that they are fully experienced with. This will avoid 'learning curve' problems. We will promote good standards of non-surgical care, similarly insisting on care-provider competence, and emphasize the need for comparable provision of rehabilitation for both groups of patients. We aim to recruit 250 patients from a minimum of 18 NHS trauma centres throughout the UK. These patients will be followed-up for 2 years. The primary outcome is the Oxford Shoulder Score, which will be collected via questionnaires completed by the trial participants at 6, 12 and 24 months. This is a 12-item condition-specific questionnaire providing a total score based on the person's subjective assessment of pain and activities of daily living impairment. We will also collect data for other outcomes, including general health measures and complications, and for an economic evaluation. Additionally, we plan a systematic collection of reasons for non-inclusion of eligible patients who were not recruited into the trial, and their baseline

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

    Directory of Open Access Journals (Sweden)

    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

  6. Evaluation of benefit to patients of training mental health professionals in suicide guidelines: cluster randomised trial.

    NARCIS (Netherlands)

    Beurs, D.P. de; Groot, M.H. de; Keijser, J. de; Duijn, E. van; Winter, R.F.P. de; Kerkhof, A.J.F.M.

    2015-01-01

    Background: Randomised studies examining the effect on patients of training professionals in adherence to suicide guidelines are scarce. Aims: To assess whether patients benefited from the training of professionals in adherence to suicide guidelines. Method: In total 45 psychiatric departments were

  7. Design of Lamifuse: a randomised, multi-centre controlled trial comparing laminectomy without or with dorsal fusion for cervical myeloradiculopathy

    Directory of Open Access Journals (Sweden)

    Grotenhuis J André

    2007-11-01

    Full Text Available Abstract Background laminectomy is a valuable surgical treatment for some patients with a cervical radiculomyelopathy due to cervical spinal stenosis. More recently attention has been given to motion of the spinal cord over spondylotic spurs as a cause of myelopathic changes. Immobilisation by fusion could have a positive effect on the recovery of myelopathic signs or changes. This has never been investigated in a prospective, randomised trial. Lamifuse is an acronyme for laminectomy and fusion. Methods/Design Lamifuse is a multicentre, randomised controlled trial comparing laminectomy with and without fusion in patients with a symptomatic cervical canal stenosis. The study population will be enrolled from patients that are 60 years or older with myelopathic signs and/or symptoms due to a cervical canal stenosis. A kyphotis shape of the cervical spine is an exclusion criterium. Each treatment arm needs 30 patients. Discussion This study will contribute to the discussion whether additional fusion after a cervical laminectomy results in a better clinical outcome. ISRCT number ISRCTN72800446

  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. Clustering of serotypes in a longitudinal study of Streptococcus pneumoniae carriage in three day care centres

    Directory of Open Access Journals (Sweden)

    Tanskanen Antti

    2008-12-01

    Full Text Available Abstract Background Streptococcus pneumoniae (pneumococcus causes a wide range of clinical manifestations that together constitute a major burden of disease worldwide. The main route of pneumococcal transmission is through asymptomatic colonisation of the nasopharynx. Studies of transmission are currently of general interest because of the impact of the new conjugate-polysaccharide vaccines on nasopharyngeal colonisation (carriage. Here we report the first longitudinal study of pneumococcal carriage that records serotype specific exposure to pneumococci simultaneously within the two most important mixing groups, families and day care facilities. Methods We followed attendees (N = 59 with their family members (N = 117 and the employees (N = 37 in three Finnish day care centres for 9 months with monthly sampling of nasopharyngeal carriage. Pneumococci were cultured, identified and serotyped by standard methods. Results Children in day care constitute a core group of pneumococcal carriage: of the 36 acquisitions of carriage with documented exposure to homologous pneumococci, the attendee had been exposed in her/his day care centre in 35 cases and in the family in 9 cases. Day care children introduce pneumococci to the family: 66% of acquisitions of a new serotype in a family were associated with simultaneous or previous carriage of the same type in the child attending day care. Consequently, pneumococcal transmission was found to take place as micro-epidemics driven by the day care centres. Each of the three day care centres was dominated by a serotype of its own, accounting for 100% of the isolates of that serotype among all samples from the day care attendees. Conclusion The transmission of pneumococci is more intense within than across clusters defined by day care facilities. The ensuing micro-epidemic behaviour enhances pneumococcal transmission.

  10. Clustering of serotypes in a longitudinal study of Streptococcus pneumoniae carriage in three day care centres

    Science.gov (United States)

    Leino, Tuija; Hoti, Fabian; Syrjänen, Ritva; Tanskanen, Antti; Auranen, Kari

    2008-01-01

    Background Streptococcus pneumoniae (pneumococcus) causes a wide range of clinical manifestations that together constitute a major burden of disease worldwide. The main route of pneumococcal transmission is through asymptomatic colonisation of the nasopharynx. Studies of transmission are currently of general interest because of the impact of the new conjugate-polysaccharide vaccines on nasopharyngeal colonisation (carriage). Here we report the first longitudinal study of pneumococcal carriage that records serotype specific exposure to pneumococci simultaneously within the two most important mixing groups, families and day care facilities. Methods We followed attendees (N = 59) with their family members (N = 117) and the employees (N = 37) in three Finnish day care centres for 9 months with monthly sampling of nasopharyngeal carriage. Pneumococci were cultured, identified and serotyped by standard methods. Results Children in day care constitute a core group of pneumococcal carriage: of the 36 acquisitions of carriage with documented exposure to homologous pneumococci, the attendee had been exposed in her/his day care centre in 35 cases and in the family in 9 cases. Day care children introduce pneumococci to the family: 66% of acquisitions of a new serotype in a family were associated with simultaneous or previous carriage of the same type in the child attending day care. Consequently, pneumococcal transmission was found to take place as micro-epidemics driven by the day care centres. Each of the three day care centres was dominated by a serotype of its own, accounting for 100% of the isolates of that serotype among all samples from the day care attendees. Conclusion The transmission of pneumococci is more intense within than across clusters defined by day care facilities. The ensuing micro-epidemic behaviour enhances pneumococcal transmission. PMID:19116005

  11. Palatal implants in the treatment of obstructive sleep apnea: a randomised, placebo-controlled single-centre trial.

    Science.gov (United States)

    Maurer, J T; Sommer, J U; Hein, G; Hörmann, K; Heiser, C; Stuck, Boris A

    2012-07-01

    Palatal implants have been used to treat snoring and mild to moderate obstructive sleep apnea (OSA). Two previous controlled trials have published conflicting results regarding the effects of palatal implants on objective outcome measures, although they both could demonstrate superiority over placebo. The aim of the present study was to assess the effects of palatal implants in patients with mild to moderate sleep apnea in a randomised, placebo-controlled trial. Twenty-two patients with mild to moderate OSA (AHI 18 ± 5, BMI 28 ± 3, age 51 ± 13 years) due to palatal obstruction were enrolled in this randomised, double-blind, placebo-controlled trial. Respiratory parameters and sleep efficiency (evaluated by polysomnography), snoring (evaluated by the bed partner), and daytime sleepiness (evaluated by ESS) were assessed before and 90 days after surgery. One patient in each group did not show up for follow-up. The AHI, HI and LSAT showed statistically significant improvement in the treatment group (p < 0.05). Snoring as rated by bed partners also showed statistically significant improvement within the treatment group (p = 0.025). There was no statistical difference when comparing the means of the treatment group with the placebo group. There were no peri- or post-operative complications and no extrusions during the follow-up period. The study supports the idea that palatal implants lead to a reduction in respiratory events in patients with mild to moderate OSA, although a statistically significant superiority of palatal implants over placebo could not be demonstrated in this trial. PMID:22228439

  12. Recruitment difficulties in a primary care cluster randomised trial: investigating factors contributing to general practitioners' recruitment of patients

    Directory of Open Access Journals (Sweden)

    McKenzie Joanne E

    2011-03-01

    Full Text Available Abstract Background Recruitment of patients by health professionals is reported as one of the most challenging steps when undertaking studies in primary care settings. Numerous investigations of the barriers to patient recruitment in trials which recruit patients to receive an intervention have been published. However, we are not aware of any studies that have reported on the recruitment barriers as perceived by health professionals to recruiting patients into cluster randomised trials where patients do not directly receive an intervention. This particular subtype of cluster trial is commonly termed a professional-cluster trial. The aim of this study was to investigate factors that contributed to general practitioners recruitment of patients in a professional-cluster trial which evaluated the effectiveness of an intervention to increase general practitioners adherence to a clinical practice guideline for acute low-back pain. Method General practitioners enrolled in the study were posted a questionnaire, consisting of quantitative items and an open-ended question, to assess possible reasons for poor patient recruitment. Descriptive statistics were used to summarise quantitative items and responses to the open-ended question were coded into categories. Results Seventy-nine general practitioners completed at least one item (79/94 = 84%, representing 68 practices (85% practice response rate, and 44 provided a response to the open-ended question. General practitioners recalled inviting a median of two patients with acute low-back pain to participate in the trial over a seven-month period; they reported that they intended to recruit patients, but forgot to approach patients to participate; and they did not perceive that patients had a strong interest or disinterest in participating. Additional open-ended comments were generally consistent with the quantitative data. Conclusion A number of barriers to the recruitment of patients with acute low

  13. Resonance scattering, absorption and off-centre abundance peaks in clusters of galaxies

    CERN Document Server

    Sanders, J S

    2006-01-01

    A possible explanation for the central abundance dips found from spatially-resolved X-ray spectroscopy of several groups and clusters of galaxies is resonance scattering. A number of the prominent iron emission lines are resonance lines. We construct a unique spectral model which takes account of resonance scattering for several thousand resonance lines, projection effects, photoelectric absorption, and allows direct spectral fitting. We apply our model to Chandra observations of two clusters with pronounced central abundance dips, Centaurus and Abell 2199. The results show that the effect of resonance scattering on emission from the centre of the cluster can be as much as 30 per cent for the Fe-K resonance lines, and 10 per cent for several Fe-L lines, if turbulence is low. The change to the metallicities obtained by fitting low resolution CCD spectra is at most 10 per cent. Accounting for resonance scattering does not remove the central dip. Allowing for internal absorption within the Centaurus significantl...

  14. Training general practitioners in the treatment of functional somatic symptoms: effects on patient health in a cluster-randomised controlled trial (the Functional Illness in Primary Care study)

    DEFF Research Database (Denmark)

    Toft, Tomas; Rosendal, Marianne; Ørnbøl, Eva;

    2010-01-01

    BACKGROUND: Patients with medically unexplained or functional somatic symptoms (FSS) are prevalent in primary care. In this pragmatic cluster-randomised controlled trial we aimed to test the effect of a training programme (The Extended Reattribution and Management model) for general practitioners...... (GPs) in the treatment of FSS. METHODS: 38 participating GPs were randomised to the control group or the training group. The GPs included consecutive 18- to 65-year-old patients presenting during a 3-week period for new health complaints. We assessed a stratified subsample with the psychiatric...

  15. Virtual patients design and its effect on clinical reasoning and student experience: a protocol for a randomised factorial multi-centre study

    Directory of Open Access Journals (Sweden)

    Bateman James

    2012-08-01

    Full Text Available Abstract Background Virtual Patients (VPs are web-based representations of realistic clinical cases. They are proposed as being an optimal method for teaching clinical reasoning skills. International standards exist which define precisely what constitutes a VP. There are multiple design possibilities for VPs, however there is little formal evidence to support individual design features. The purpose of this trial is to explore the effect of two different potentially important design features on clinical reasoning skills and the student experience. These are the branching case pathways (present or absent and structured clinical reasoning feedback (present or absent. Methods/Design This is a multi-centre randomised 2x2 factorial design study evaluating two independent variables of VP design, branching (present or absent, and structured clinical reasoning feedback (present or absent.The study will be carried out in medical student volunteers in one year group from three university medical schools in the United Kingdom, Warwick, Keele and Birmingham. There are four core musculoskeletal topics. Each case can be designed in four different ways, equating to 16 VPs required for the research. Students will be randomised to four groups, completing the four VP topics in the same order, but with each group exposed to a different VP design sequentially. All students will be exposed to the four designs. Primary outcomes are performance for each case design in a standardized fifteen item clinical reasoning assessment, integrated into each VP, which is identical for each topic. Additionally a 15-item self-reported evaluation is completed for each VP, based on a widely used EViP tool. Student patterns of use of the VPs will be recorded. In one centre, formative clinical and examination performance will be recorded, along with a self reported pre and post-intervention reasoning score, the DTI. Our power calculations indicate a sample size of 112 is required for

  16. CRISTOPH – A cluster-randomised intervention study to optimise the treatment of patients with hypertension in General Practice

    Directory of Open Access Journals (Sweden)

    Wegscheider Karl

    2008-06-01

    Full Text Available Abstract Background Recent guidelines for the management of hypertension focus on treating patients according to their global cardiovascular risk (CVR, rather than strictly keeping blood pressure, or other risk factors, below set limit values. The objective of this study is to compare the effect of a simple versus a complex educational intervention implementing this new concept among General Practitioners (GPs. Methods/design A prospective longitudinal cluster-randomised intervention trial with 94 German GPs consecutively enroling 40 patients each with known hypertension. All GPs then received a written manual specifically developed to transfer the global concept of CVR into daily General Practice. After cluster-randomisation, half of the GPs additionally received a clinical outreach visit, with a trained peer discussing with them the concept of global CVR referring to example study patients from the respective GP. Main outcome measure is the improvement of calculated CVR six months after intervention in the subgroup of patients with high CVR (but no history of cardiovascular disease, defined as 10-year-mortality ≥ 5% employing the European SCORE formula. Secondary outcome measures include the intervention's effect on single risk factors, and on prescription rates of drugs targeting CVR. All outcome measures are separately studied in the three subgroups of patients with 1. high CVR (defined as above, 2. low CVR (SCORE Discussion To our knowledge, no other published intervention study has yet evaluated the impact of educating GPs with the goal to treat patients with hypertension according to their global cardiovascular risk. Trial registration ISRCTN44478543

  17. The QICKD study protocol: a cluster randomised trial to compare quality improvement interventions to lower systolic BP in chronic kidney disease (CKD in primary care

    Directory of Open Access Journals (Sweden)

    du Bois Elizabeth

    2009-07-01

    Full Text Available Abstract Background Chronic kidney disease (CKD is a relatively newly recognised but common long-term condition affecting 5 to 10% of the population. Effective management of CKD, with emphasis on strict blood pressure (BP control, reduces cardiovascular risk and slows the progression of CKD. There is currently an unprecedented rise in referral to specialist renal services, which are often located in tertiary centres, inconvenient for patients, and wasteful of resources. National and international CKD guidelines include quality targets for primary care. However, there have been no rigorous evaluations of strategies to implement these guidelines. This study aims to test whether quality improvement interventions improve primary care management of elevated BP in CKD, reduce cardiovascular risk, and slow renal disease progression Design Cluster randomised controlled trial (CRT Methods This three-armed CRT compares two well-established quality improvement interventions with usual practice. The two interventions comprise: provision of clinical practice guidelines with prompts and audit-based education. The study population will be all individuals with CKD from general practices in eight localities across England. Randomisation will take place at the level of the general practices. The intended sample (three arms of 25 practices powers the study to detect a 3 mmHg difference in systolic BP between the different quality improvement interventions. An additional 10 practices per arm will receive a questionnaire to measure any change in confidence in managing CKD. Follow up will take place over two years. Outcomes will be measured using anonymised routinely collected data extracted from practice computer systems. Our primary outcome measure will be reduction of systolic BP in people with CKD and hypertension at two years. Secondary outcomes will include biomedical outcomes and markers of quality, including practitioner confidence in managing CKD. A small

  18. The nutrition-based comprehensive intervention study on childhood obesity in China (NISCOC: a randomised cluster controlled trial

    Directory of Open Access Journals (Sweden)

    Xu Guifa

    2010-05-01

    Full Text Available Abstract Background Childhood obesity and its related metabolic and psychological abnormalities are becoming serious health problems in China. Effective, feasible and practical interventions should be developed in order to prevent the childhood obesity and its related early onset of clinical cardiovascular diseases. The objective of this paper is to describe the design of a multi-centred random controlled school-based clinical intervention for childhood obesity in China. The secondary objective is to compare the cost-effectiveness of the comprehensive intervention strategy with two other interventions, one only focuses on nutrition education, the other only focuses on physical activity. Methods/Design The study is designed as a multi-centred randomised controlled trial, which included 6 centres located in Beijing, Shanghai, Chongqing, Shandong province, Heilongjiang province and Guangdong province. Both nutrition education (special developed carton style nutrition education handbook and physical activity intervention (Happy 10 program will be applied in all intervention schools of 5 cities except Beijing. In Beijing, nutrition education intervention will be applied in 3 schools and physical activity intervention among another 3 schools. A total of 9750 primary students (grade 1 to grade 5, aged 7-13 years will participate in baseline and intervention measurements, including weight, height, waist circumference, body composition (bioelectrical impendence device, physical fitness, 3 days dietary record, physical activity questionnaire, blood pressure, plasma glucose and plasma lipid profiles. Data concerning investments will be collected in our study, including costs in staff training, intervention materials, teachers and school input and supervising related expenditure. Discussion Present study is the first and biggest multi-center comprehensive childhood obesity intervention study in China. Should the study produce comprehensive results, the

  19. A cluster randomised controlled trial of nurse and GP partnership for care of Chronic Obstructive Pulmonary Disease

    Directory of Open Access Journals (Sweden)

    Middleton Sandy

    2008-06-01

    Full Text Available Abstract Background Chronic obstructive pulmonary disease (COPD is a significant health problem worldwide. This randomised controlled trial aims at testing a new approach that involves a registered nurse working in partnership with patients, general practitioners (GPs and other health professionals to provide care to patients according to the evidence-based clinical practice guidelines. The aim is to determine the impact of this partnership on the quality of care and patient outcomes. Methods A cluster randomised control trial design was chosen for this study. Randomisation occurred at practice level. GPs practising in South Western Sydney, Australia and their COPD patients were recruited for the study. The intervention was implemented by nurses specifically recruited and trained for this study. Nurses, working in partnership with GPs, developed care plans for patients based on the Australian COPDX guidelines. The aim was to optimise patient management, improve function, prevent deterioration and enhance patient knowledge and skills. Control group patients received 'usual' care from their GPs. Data collection includes patient demographic profiles and their co-morbidities. Spirometry is being performed to assess patients' COPD status and CO analyser to validate their smoking status. Patients' quality of life and overall health status are being measured by St George's Respiratory Questionnaire and SF-12 respectively. Other patient measures being recorded include health service use, immunisation status, and knowledge of COPD. Qualitative methods will be used to explore participants' satisfaction with the intervention and their opinion about the value of the partnership. Analysis Analysis will be by intention to treat. Intra-cluster (practice correlation coefficients will be determined and published for all primary outcome variables to assist future research. The effect of the intervention on outcomes measured on a continuous scale will be estimated

  20. Massive black holes interactions during the assembly of heavy sub-structures in the centre of galaxy clusters

    CERN Document Server

    Donnari, M; Merafina, M

    2016-01-01

    We performed a series of direct N-body simulations with the aim to follow the dynamical evolution of a galaxy cluster (GC) ($M_{clus}\\simeq 10^{14} M_{\\odot}$) in different environment. The results show the formation of heavy sub-structures in the cluster centre in consequence of multiple merging among the innermost galaxies. Moreover we investigate the dynamics of super-massive black holes (SMBHs) residing in the centre of galaxies that form the most massive sub-structure.

  1. Feasibility, double-blind, randomised, placebo-controlled, multi-centre trial of hand-held NB-UVB phototherapy for the treatment of vitiligo at home (HI-Light trial: Home Intervention of Light therapy)

    OpenAIRE

    Eleftheriadou, Viktoria; Thomas, Kim; Ravenscroft, Jane; Whitton, Maxine; Batchelor, Jonathan; Williams, Hywel

    2014-01-01

    Background Hand-held NB-UVB units are lightweight devices that may overcome the need to treat vitiligo in hospital-based phototherapy cabinets, allowing early treatment at home that may enhance the likelihood of successful repigmentation. The pilot Hi-Light trial examined the feasibility of conducting a large multi-centre randomised controlled trial (RCT) on the use of such devices by exploring recruitment, adherence, acceptability, and patient education. Methods This was a feasibility, doubl...

  2. Formation and evolution of heavy sub-structures in the centre of galaxy clusters: the local effect of dark energy

    CERN Document Server

    Sedda, Manuel Arca; Merafina, Marco

    2016-01-01

    We discuss how the centres of galaxy clusters evolve in time, showing the results of a series of direct N-body simulations. In particular, we followed the evolution of a galaxy cluster with a mass $M_{clus} \\simeq 10^{14} $M$_{\\odot}$ in different configurations. The dynamical evolution of the system leads in all the cases to the formation of dense and massive sub-structures in the cluster centre, that form in consequence of a series of collisions and merging among galaxies travelling in the cluster core. We investigate how the structural properties of the main merging product depends on the characteristics of those galaxies that contributed to its formation.

  3. Gatifloxacin versus ceftriaxone for uncomplicated enteric fever in Nepal: an open-label, two-centre, randomised controlled trial

    Science.gov (United States)

    Arjyal, Amit; Basnyat, Buddha; Nhan, Ho Thi; Koirala, Samir; Giri, Abhishek; Joshi, Niva; Shakya, Mila; Pathak, Kamal Raj; Mahat, Saruna Pathak; Prajapati, Shanti Pradhan; Adhikari, Nabin; Thapa, Rajkumar; Merson, Laura; Gajurel, Damodar; Lamsal, Kamal; Lamsal, Dinesh; Yadav, Bharat Kumar; Shah, Ganesh; Shrestha, Poojan; Dongol, Sabina; Karkey, Abhilasha; Thompson, Corinne N; Thieu, Nga Tran Vu; Thanh, Duy Pham; Baker, Stephen; Thwaites, Guy E; Wolbers, Marcel; Dolecek, Christiane

    2016-01-01

    Summary Background Because treatment with third-generation cephalosporins is associated with slow clinical improvement and high relapse burden for enteric fever, whereas the fluoroquinolone gatifloxacin is associated with rapid fever clearance and low relapse burden, we postulated that gatifloxacin would be superior to the cephalosporin ceftriaxone in treating enteric fever. Methods We did an open-label, randomised, controlled, superiority trial at two hospitals in the Kathmandu valley, Nepal. Eligible participants were children (aged 2–13 years) and adult (aged 14–45 years) with criteria for suspected enteric fever (body temperature ≥38·0°C for ≥4 days without a focus of infection). We randomly assigned eligible patients (1:1) without stratification to 7 days of either oral gatifloxacin (10 mg/kg per day) or intravenous ceftriaxone (60 mg/kg up to 2 g per day for patients aged 2–13 years, or 2 g per day for patients aged ≥14 years). The randomisation list was computer-generated using blocks of four and six. The primary outcome was a composite of treatment failure, defined as the occurrence of at least one of the following: fever clearance time of more than 7 days after treatment initiation; the need for rescue treatment on day 8; microbiological failure (ie, blood cultures positive for Salmonella enterica serotype Typhi, or Paratyphi A, B, or C) on day 8; or relapse or disease-related complications within 28 days of treatment initiation. We did the analyses in the modified intention-to-treat population, and subpopulations with either confirmed blood-culture positivity, or blood-culture negativity. The trial was powered to detect an increase of 20% in the risk of failure. This trial was registered at ClinicalTrials.gov, number NCT01421693, and is now closed. Findings Between Sept 18, 2011, and July 14, 2014, we screened 725 patients for eligibility. On July 14, 2014, the trial was stopped early by the data safety and monitoring board because S Typhi

  4. Web-based guided insulin self-titration in patients with type 2 diabetes: the Di@log study. Design of a cluster randomised controlled trial [TC1316

    Directory of Open Access Journals (Sweden)

    Kostense Piet J

    2009-06-01

    Full Text Available Abstract Background Many patients with type 2 diabetes (T2DM are not able to reach the glycaemic target level of HbA1c Methods/Design T2DM patients (n = 248, aged 35–75 years, with an HbA1c ≥ 7.0%, eligible for treatment with insulin and able to use the internet will be selected from general practices in two different regions in the Netherlands. Cluster randomisation will be performed at the level of general practices. Patients in the intervention group will use a self-developed internet programme to assist them in self-titrating insulin. The control group will receive usual care. Primary outcome is the difference in change in HbA1c between intervention and control group. Secondary outcome measures are quality of life, treatment satisfaction, diabetes self-efficacy and frequency of hypoglycaemic episodes. Results will be analysed according to the intention-to-treat principle. Discussion An internet intervention supporting self-titration of insulin therapy in T2DM patients is an innovative patient-centred intervention. The programme provides guided self-monitoring and evaluation of health and self-care behaviours through tailored feedback on input of glucose values. This is expected to result in a better performance of self-titration of insulin and consequently in the improvement of glycaemic control. The patient will be enabled to 'discover and use his or her own ability to gain mastery over his/her diabetes' and therefore patient empowerment will increase. Based on the self-regulation theory of Leventhal, we hypothesize that additional benefits will be achieved in terms of increases in treatment satisfaction, quality of life and self-efficacy. Trial registration Dutch Trial Register TC1316.

  5. Cluster randomised trial in the General Practice Research Database: 1. Electronic decision support to reduce antibiotic prescribing in primary care (eCRT study

    Directory of Open Access Journals (Sweden)

    Charlton Judith

    2011-05-01

    Full Text Available Abstract Background The purpose of this research is to develop and evaluate methods for conducting cluster randomised trials in a primary care database that contains electronic patient records for large numbers of family practices. Cluster randomised trials are trials in which the units allocated represent groups of individuals, in this case family practices and their registered patients. Cluster randomised trials often suffer from the limitation that they include too few clusters, leading to problems of insufficient power and only imprecise estimation of the intraclass correlation coefficient, a key design parameter. This difficulty might be overcome by utilising databases that already hold electronic patient records for large numbers of practices. The protocol describes one application: a study of antibiotic prescribing for acute respiratory infection; a second protocol outlines an intervention in a less frequent chronic condition of public health importance, stroke. Methods/Design The objective of the study is to implement a cluster randomised trial to test the effectiveness of an electronic record-based intervention at achieving a reduction in antibiotic prescribing at consultations for respiratory illness in patients aged 18 and 59 years old in intervention family practices as compared with controls. Family practices will be recruited from the practices that presently contribute data to the UK General Practice Research Database (GPRD. Following randomisation, electronic prompts will be installed remotely at intervention practices to promote adherence with evidence-based standards of medical practice. The intervention was developed through qualitative research at non-intervention practices. Data for outcome assessment will be obtained from anonymised electronic patient records that are routinely collected into GPRD. This protocol outlines the proposed study designs, data sources, sample size requirements, analysis methods and dissemination

  6. 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

  7. Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study

    Directory of Open Access Journals (Sweden)

    Grant Adrian M

    2006-12-01

    Full Text Available Abstract Background Securing and managing finances for multicentre randomised controlled trials is a highly complex activity which is rarely considered in the research literature. This paper describes the process of financial negotiation and the impact of financial considerations in four UK multicentre trials. These trials had met, or were on schedule to meet, recruitment targets agreed with their public-sector funders. The trials were considered within a larger study examining factors which might be associated with trial recruitment (STEPS. Methods In-depth semi-structured telephone interviews were conducted in 2003–04 with 45 individuals with various responsibilities to one of the four trials. Interviewees were recruited through purposive and then snowball sampling. Interview transcripts were analysed with the assistance of the qualitative package Atlas-ti. Results The data suggest that the UK system of dividing funds into research, treatment and NHS support costs brought the trial teams into complicated negotiations with multiple funders. The divisions were somewhat malleable and the funding system was used differently in each trial. The fact that all funders had the potential to influence and shape the trials considered here was an important issue as the perspectives of applicants and funders could diverge. The extent and range of industry involvement in non-industry-led trials was striking. Three broad periods of financial work (foundation, maintenance, and resourcing completion were identified. From development to completion of a trial, the trialists had to be resourceful and flexible, adapting to changing internal and external circumstances. In each period, trialists and collaborators could face changing costs and challenges. Each trial extended the recruitment period; three required funding extensions from MRC or HTA. Conclusion This study highlights complex financial aspects of planning and conducting trials, especially where multiple

  8. The effectiveness of the Austrian disease management programme for type 2 diabetes: a cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Klima Gert

    2010-11-01

    Full Text Available Abstract Background Disease management programmes (DMPs are costly and impose additional work load on general practitioners (GPs. Data on their effectiveness are inconclusive. We therefore conducted a cluster-randomised controlled trial to evaluate the effectiveness of the Austrian DMP for diabetes mellitus type 2 on HbA1c and quality of care for adult patients in primary care. Methods All GPs of Salzburg-province were invited to participate. After cluster-randomisation by district, all patients with diabetes type 2 were recruited consecutively from 7-11/2007. The DMP, consisting mainly of physician and patient education, standardised documentation and agreement on therapeutic goals, was implemented in the intervention group while the control group received usual care. We aimed to show superiority of the intervention regarding metabolic control and process quality. The primary outcome measure was a change in HbA1c after one year. Secondary outcomes were days in the hospital, blood pressure, lipids, body mass index (BMI, enrolment in patient education and regular guideline-adherent examination. Blinding was not possible. Results 92 physicians recruited 1489 patients (649 intervention, 840 control. After 401 ± 47 days, 590 intervention-patients and 754 controls had complete data. In the intention to treat analysis (ITT of all 1489 patients, HbA1c decreased 0.41% in the intervention group and 0.28% in controls. The difference of -0.13% (95% CI -0.24; -0.02 was significant at p = 0.026. Significance was lost in mixed models adjusted for baseline value and cluster-effects (adjusted mean difference -0.03 (95% CI -0.15; 0.09, p = 0.607. Of the secondary outcome measures, BMI and cholesterol were significantly reduced in the intervention group compared to controls in ITT after adjustments (-0.53 kg/m²; 95% CI -1.03;-0.02; p = 0.014 and -0.10 mmol/l; 95% CI -0.21; -0.003; p = 0.043. Additionally, more patients received patient education (49.5% vs. 20

  9. A cluster randomised controlled trial of the efficacy of a brief walking intervention delivered in primary care: Study protocol

    Directory of Open Access Journals (Sweden)

    Szczepura Ala

    2011-06-01

    Full Text Available Abstract Background The aim of the present research is to conduct a fully powered explanatory trial to evaluate the efficacy of a brief self-regulation intervention to increase walking. The intervention will be delivered in primary care by practice nurses (PNs and Healthcare Assistants (HCAs to patients for whom increasing physical activity is a particular priority. The intervention has previously demonstrated efficacy with a volunteer population, and subsequently went through an iterative process of refinement in primary care, to maximise acceptability to both providers and recipients. Methods/ Design This two arm cluster randomised controlled trial set in UK general practices will compare two strategies for increasing walking, assessed by pedometer, over six months. Patients attending practices randomised to the self-regulation intervention arm will receive an intervention consisting of behaviour change techniques designed to increase walking self-efficacy (confidence in ability to perform the behaviour, and to help people translate their "good" intentions into behaviour change by making plans. Patients attending practices randomised to the information provision arm will receive written materials promoting walking, and a short unstructured discussion about increasing their walking. The trial will recruit 20 PN/HCAs (10 per arm, who will be trained by the research team to deliver the self-regulation intervention or information provision control intervention, to 400 patients registered at their practices (20 patients per PN/HCA. This will provide 85% power to detect a mean difference of five minutes/day walking between the self-regulation intervention group and the information provision control group. Secondary outcomes include health services costs, and intervention effects in sub-groups defined by age, ethnicity, gender, socio-economic status, and clinical condition. A mediation analysis will investigate the extent to which changes in

  10. An exploratory cluster randomised trial of a university halls of residence based social norms intervention in Wales, UK

    Directory of Open Access Journals (Sweden)

    Murphy Simon

    2012-03-01

    Full Text Available Abstract Background Excessive alcohol consumption amongst university students has received increasing attention. A social norms approach to reducing drinking behaviours has met with some success in the USA. Such an approach is based on the assumption that student's perceptions of the norms of their peers are highly influential, but that these perceptions are often incorrect. Social norms interventions therefore aim to correct these inaccurate perceptions, and in turn, to change behaviours. However, UK studies are scarce and it is increasingly recognised that social norm interventions need to be supported by socio ecological approaches that address the wider determinants of behaviour. Objectives To describe the research design for an exploratory trial examining the acceptability, hypothesised process of change and implementation of a social norm marketing campaign designed to correct misperceptions of normative alcohol use and reduce levels of misuse, implemented alongside a university wide alcohol harm reduction toolkit. It also assesses the feasibility of a potential large scale effectiveness trial by providing key trial design parameters including randomisation, recruitment and retention, contamination, data collection methods, outcome measures and intracluster correlations. Methods/design The study adopts an exploratory cluster randomised controlled trial design with halls of residence as the unit of allocation, and a nested mixed methods process evaluation. Four Welsh (UK universities participated in the study, with residence hall managers consenting to implementation of the trial in 50 university owned campus based halls of residence. Consenting halls were randomised to either a phased multi channel social norm marketing campaign addressing normative discrepancies (n = 25 intervention or normal practice (n = 25 control. The primary outcome is alcohol consumption (units per week measured using the Daily Drinking Questionnaire. Secondary

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

    Directory of Open Access Journals (Sweden)

    Zwar Nicholas

    2010-08-01

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

  12. A 10-Week Multimodal Nutrition Education Intervention Improves Dietary Intake among University Students: Cluster Randomised Controlled Trial

    Directory of Open Access Journals (Sweden)

    Mohd Razif Shahril

    2013-01-01

    Full Text Available The aim of the study was to evaluate the effectiveness of implementing multimodal nutrition education intervention (NEI to improve dietary intake among university students. The design of study used was cluster randomised controlled design at four public universities in East Coast of Malaysia. A total of 417 university students participated in the study. They were randomly selected and assigned into two arms, that is, intervention group (IG or control group (CG according to their cluster. The IG received 10-week multimodal intervention using three modes (conventional lecture, brochures, and text messages while CG did not receive any intervention. Dietary intake was assessed before and after intervention and outcomes reported as nutrient intakes as well as average daily servings of food intake. Analysis of covariance (ANCOVA and adjusted effect size were used to determine difference in dietary changes between groups and time. Results showed that, compared to CG, participants in IG significantly improved their dietary intake by increasing their energy intake, carbohydrate, calcium, vitamin C and thiamine, fruits and 100% fruit juice, fish, egg, milk, and dairy products while at the same time significantly decreased their processed food intake. In conclusion, multimodal NEI focusing on healthy eating promotion is an effective approach to improve dietary intakes among university students.

  13. Knowledge transfer for the management of dementia: a cluster-randomised trial of blended learning in general practice

    Directory of Open Access Journals (Sweden)

    Butzlaff Martin E

    2010-01-01

    Full Text Available Abstract Background The implementation of new medical knowledge into general practice is a complex process. Blended learning may offer an effective and efficient educational intervention to reduce the knowledge-to-practice gap. The aim of this study was to compare knowledge acquisition about dementia management between a blended learning approach using online modules in addition to quality circles (QCs and QCs alone. Methods In this cluster-randomised trial with QCs as clusters and general practitioners (GPs as participants, 389 GPs from 26 QCs in the western part of Germany were invited to participate. Data on the GPs' knowledge were obtained at three points in time by means of a questionnaire survey. Primary outcome was the knowledge gain before and after the interventions. A subgroup analysis of the users of the online modules was performed. Results 166 GPs were available for analysis and filled out a knowledge test at least two times. A significant increase of knowledge was found in both groups that indicated positive learning effects of both approaches. However, there was no significant difference between the groups. A subgroup analysis of the GPs who self-reported that they had actually used the online modules showed that they had a significant increase in their knowledge scores. Conclusion A blended learning approach was not superior to a QCs approach for improving knowledge about dementia management. However, a subgroup of GPs who were motivated to actually use the online modules had a gain in knowledge. Trial registration Current Controlled Trials ISRCTN36550981.

  14. The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder - study protocol of the randomised, multi-centre controlled SOSTA - net trial

    Directory of Open Access Journals (Sweden)

    Freitag Christine M

    2013-01-01

    Full Text Available Abstract Background Group-based social skills training (SST has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD. To date, no sufficiently powered randomised controlled trial has been performed to establish efficacy and safety of SST in children and adolescents with HFASD. In this randomised, multi-centre, controlled trial with 220 children and adolescents with HFASD it is hypothesized, that add-on group-based SST using the 12 weeks manualised SOSTA–FRA program will result in improved social responsiveness (measured by the parent rated social responsiveness scale, SRS compared to treatment as usual (TAU. It is further expected, that parent and self reported anxiety and depressive symptoms will decline and pro-social behaviour will increase in the treatment group. A neurophysiological study in the Frankfurt HFASD subgroup will be performed pre- and post treatment to assess changes in neural function induced by SST versus TAU. Methods/design The SOSTA – net trial is designed as a prospective, randomised, multi-centre, controlled trial with two parallel groups. The primary outcome is change in SRS score directly after the intervention and at 3 months follow-up. Several secondary outcome measures are also obtained. The target sample consists of 220 individuals with ASD, included at the six study centres. Discussion This study is currently one of the largest trials on SST in children and adolescents with HFASD worldwide. Compared to recent randomised controlled studies, our study shows several advantages with regard to in- and exclusion criteria, study methods, and the therapeutic approach chosen, which can be easily implemented in non-university-based clinical settings. Trial registration ISRCTN94863788 – SOSTA – net: Group-based social skills training in children and adolescents with high functioning autism spectrum disorder.

  15. The Irish DAFNE study protocol: a cluster randomised trial of group versus individual follow-up after structured education for type 1 diabetes.

    LENUS (Irish Health Repository)

    Dinneen, Seán F

    2009-01-01

    BACKGROUND: Structured education programmes for individuals with Type 1 diabetes have become a recognised means of delivering the knowledge and skills necessary for optimal self-management of the condition. The Dose Adjustment for Normal Eating (DAFNE) programme has been shown to improve biomedical (HbA(1c) and rates of severe hypoglycaemia) and psychosocial outcomes for up to 12 months following course delivery. The optimal way to support DAFNE graduates and maintain the benefits of the programme has not been established. We aimed to compare 2 different methods of follow-up of DAFNE graduates in a pragmatic clinical trial delivered in busy diabetes clinics on the island of Ireland. METHODS: Six participating centres were cluster randomised to deliver either group follow-up or a return to traditional one-to-one clinic visits. In the intervention arm group follow-up was delivered at 6 and 12 months post DAFNE training according to a curriculum developed for the study. In the control arm patients were seen individually in diabetes clinics as part of routine care. Study outcomes included HbA(1c) levels, self-reported rates of severe hypoglycaemia, body weight and measures of diabetes wellbeing and quality of life. These were measured at 6, 12 and 18 months after recruitment. Generalisability (external validity) was maximised by recruiting study participants from existing DAFNE waiting lists in each centre, by using broad inclusion criteria (including HbA(1c) values less than 13 percent with no lower limit) and by using existing clinic staff to deliver the training and follow-up. Internal validity and treatment fidelity were maximised by quality assuring the training of all DAFNE educators, by external peer review of the group follow-up sessions and by striving for full attendance at follow-up visits. Assays of HbA(1c) were undertaken in a central laboratory. DISCUSSION: This pragmatic clinical trial evaluating group follow-up after a structured education programme has

  16. Little effect of transfer technique instruction and physical fitness training in reducing low back pain among nurses: a cluster randomised intervention study

    DEFF Research Database (Denmark)

    Warming, S; Ebbehøj, N E; Wiese, N;

    2008-01-01

    The aim of this study was to evaluate the effect of a transfer technique education programme (TT) alone or in combination with physical fitness training (TTPT) compared with a control group, who followed their usual routine. Eleven clinical hospital wards were cluster randomised to either...... intervention (six wards) or to control (five wards). The intervention cluster was individually randomised to TT (55 nurses) and TTPT (50 nurses), control (76 nurses). The transfer technique programme was a 4-d course of train-the-trainers to teach transfer technique to their colleagues. The physical training...... consisted of supervised physical fitness training 1 h twice per week for 8 weeks. Implementing transfer technique alone or in combination with physical fitness training among a hospital nursing staff did not, when compared to a control group, show any statistical differences according to self-reported low...

  17. Impact of a theoretically based sex education programme (SHARE) delivered by teachers on NHS registered conceptions and terminations: final results of cluster randomised trial

    OpenAIRE

    Henderson, M.; Wight, D; Raab, G M; Abraham, C.; Parkes, A; Scott, S.; Hart, G.

    2007-01-01

    Objective To assess the impact of a theoretically based sex education programme (SHARE) delivered by teachers compared with conventional education in terms of conceptions and terminations registered by the NHS.Design Follow-up of cluster randomised trial 4.5 years after intervention.Setting NHS records of women who had attended 25 secondary schools in east Scotland.Participants 4196 women (99.5% of those eligible) Intervention SHARE programme (intervention group) v existing sex education (con...

  18. Impact of a theoretically based sex education programme (SHARE) delivered by teachers on NHS registered conceptions and terminations: final results of cluster randomised trial

    OpenAIRE

    Wright, D; Raab, G M; Abraham, C.; Scott, S.; Hart, G.

    2006-01-01

    Objective: To assess the impact of a theoretically based sex education programme (SHARE) delivered by teachers compared with conventional education in terms of conceptions and terminations registered by the NHS. Design Follow-up of cluster randomised trial 4.5 years after intervention. Setting: NHS records of women who had attended 25 secondary schools in east Scotland. Participants: 4196 women (99.5% of those eligible). Intervention: SHARE programme (intervention group) v ...

  19. Impact of a personal learning plan supported by an induction meeting on academic performance in undergraduate Obstetrics and Gynaecology: a cluster randomised controlled trial

    OpenAIRE

    Deane, Richard P; Murphy, Deirdre J

    2015-01-01

    Background A personal learning plan (PLP) is an approach to assist medical students maximise their learning experience within clinical rotations. The aim of this study was to investigate whether medical students who created a PLP supported by an induction meeting had an improved academic performance within an undergraduate clinical rotation. Methods A cluster randomised controlled study was conducted over a full academic year (2012/13). The intervention was the creation of a PLP by medical st...

  20. Effects of a 20-month cluster randomised controlled school-based intervention trial on BMI of school-aged boys and girls: the HEIA study

    OpenAIRE

    Grydeland, May; Bjelland, Mona; Anderssen, Sigmund Alfred; Klepp, Knut-Inge; Bergh, Ingunn Holden; Andersen, Lene Frost; Ommundsen, Yngvar; Lien, Nanna

    2013-01-01

    Background School-based interventions that target prevention of overweight and obesity in children have been tested with mixed results. Thus, successful interventions are still called for. The aim of the present study was to investigate effects of a multicomponent school-based intervention programme targeting physical activity, sedentary and dietary behaviours on anthropometric outcomes. Methods A 20-month intervention was evaluated in a cluster randomised, controlled study of 1324 11-year-ol...

  1. Increasing chlamydia screening tests in general practice: A modi fied Zelen prospective cluster randomised controlled trial evaluating a complex intervention based on the theory of planned behaviour

    OpenAIRE

    McNulty, C A M; Hogan, A.; Ricketts, E.; Wallace, L.; Oliver, I; Campbell, R.; Kalwij, S.; O'Connell, E; Charlett, A.

    2014-01-01

    Objective: To determine if a structured complex intervention increases opportunistic chlamydia screening testing of patients aged 15-24 years attending English general practitioner (GP) practices. Methods: A prospective, Cluster Randomised Controlled Trial with a modified Zelen design involving 160 practices in South West England in 2010. The intervention was based on the Theory of Planned Behaviour (TPB). It comprised of practice-based education with up to two additional contacts to incre...

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

    OpenAIRE

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

    2010-01-01

    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 ai...

  3. A process evaluation of a cluster randomised trial to reduce potentially inappropriate prescribing in older people in primary care (OPTI-SCRIPT study)

    OpenAIRE

    Clyne, Barbara; Cooper, Janine A; Hughes, Carmel M.; Fahey, Tom; Smith, Susan M

    2016-01-01

    BackgroundThe OPTI-SCRIPT cluster randomised controlled trial (RCT) found that a three-phase multifaceted intervention including academic detailing with a pharmacist, GP-led medicines reviews, supported by web-based pharmaceutical treatment algorithms, and tailored patient information leaflets, was effective in reducing potentially inappropriate prescribing (PIP) in Irish primary care. We report a process evaluation exploring the implementation of the intervention, the experiences of those pa...

  4. A cluster randomised controlled trial of the community effectiveness of two interventions in rural Malawi to improve health care and to reduce maternal, newborn and infant mortality

    OpenAIRE

    Vergnano Stefania; Malamba Florida; Chapota Hilda; Rosato Mikey; Mganga Andrew; Phiri Tambosi; Kazembe Peter; Mwansambo Charles; Lewycka Sonia; Newell Marie-Louise; Osrin David; Costello Anthony

    2010-01-01

    Abstract Background The UN Millennium Development Goals call for substantial reductions in maternal and child mortality, to be achieved through reductions in morbidity and mortality during pregnancy, delivery, postpartum and early childhood. The MaiMwana Project aims to test community-based interventions that tackle maternal and child health problems through increasing awareness and local action. Methods/Design This study uses a two-by-two factorial cluster-randomised controlled trial design ...

  5. Prescriber and Patient-oriented Behavioural Interventions to Improve use of Malaria Rapid Diagnostic Tests in Tanzania: Facility-based Cluster Randomised Trial.

    OpenAIRE

    Cundill, B; Mbakilwa, H; Chandler, CI; Mtove, G.; Mtei, F; Willetts, A; Foster, E; Muro, F.; Mwinyishehe, R; Mandike, R; Olomi, R; Whitty, CJ; Reyburn, H

    2015-01-01

    Background The increasing investment in malaria rapid diagnostic tests (RDTs) to differentiate malarial and non-malarial fevers, and an awareness of the need to improve case management of non-malarial fever, indicates an urgent need for high quality evidence on how best to improve prescribers’ practices. Methods A three-arm stratified cluster-randomised trial was conducted in 36 primary healthcare facilities from September 2010 to March 2012 within two rural districts in northeast Tanzania wh...

  6. The effect of motivational interviewing on oral healthcare knowledge, attitudes and behaviour of parents and caregivers of preschool children: an exploratory cluster randomised controlled study

    OpenAIRE

    Naidu, Rahul; Nunn, June; Irwin, Jennifer D.

    2015-01-01

    Background Motivational Interviewing (MI) has been used across primary healthcare and been shown to be effective in reducing the prevalence of early childhood caries (ECC) in preschool children. This study aimed to compare the effect of MI, in contrast to traditional dental health education (DHE), on oral health knowledge, attitudes, beliefs and behaviours among parents and caregivers of preschool children in Trinidad. Method The design of this exploratory study included a cluster randomised ...

  7. Hepatitis C infection among injecting drug users in general practice: a cluster randomised controlled trial of clinical guidelines' implementation

    Science.gov (United States)

    Cullen, Walter; Stanley, June; Langton, Deirdre; Kelly, Yvonne; Staines, Anthony; Bury, Gerard

    2006-01-01

    Background Hepatitis C is a common infection among injecting drug users and has important implications for general practice. Although several clinical guidelines concerning the infection have been published, their effectiveness has yet to be tested. Aim To assess the effectiveness of a general practice-based complex intervention to support the implementation of clinical guidelines for hepatitis C management among current or former drug users attending general practice. Design of study Cluster randomised controlled trial. Setting General practices in the Eastern Regional Health Authority area of Ireland. Method Twenty-six practices were randomly allocated within strata to receive the intervention under study or to provide care as usual for a period of 6 months. There was screening for patients attending general practice for methadone maintenance treatment for hepatitis C and referral of anti-HCV antibody positive patients to a specialist hepatology department for assessment. Results At study completion, patients in the intervention group were significantly more likely to have been screened for hepatitis C than those in the control group, odds ratio adjusted for clustering 3.76 (95% confidence interval [CI] = 1.3 to 11.3) and this association remained significant after adjusting for other potentially confounding variables, using multiple logistic regression, with the odds ratio adjusted for clustering 4.53 (95% CI = 1.39 to 14.78). Although anti-HCV antibody positive patients in the intervention group were more likely to have been referred to a hepatology clinic, this was not statistically significant (P = 0.06). Conclusion General practice has an important role in the care of people at risk of hepatitis C and when appropriately supported can effectively implement current best practice. PMID:17132352

  8. A cluster randomised trial introducing rapid diagnostic tests into registered drug shops in Uganda

    DEFF Research Database (Denmark)

    Mbonye, Anthony K; Magnussen, Pascal; Lal, Sham;

    2015-01-01

    the impact of introducing rapid diagnostic tests for malaria (mRDTs) in registered drug shops in Uganda, with the aim to increase appropriate treatment of malaria with artemisinin-based combination therapy (ACT) in patients seeking treatment for fever in drug shops. METHODS: A cluster-randomized trial...... adhered to the mRDT results, reducing over-treatment of malaria by 72·6% (95% CI: 46·7- 98·4), pDiagnostic testing with mRDTs compared to presumptive treatment of fevers implemented in registered drug shops...... of introducing mRDTs in registered drug shops was implemented in 20 geographical clusters of drug shops in Mukono district, central Uganda. Ten clusters were randomly allocated to the intervention (diagnostic confirmation of malaria by mRDT followed by ACT) and ten clusters to the control arm (presumptive...

  9. The IDvIP Trial: A two-centre randomised double-blind controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia

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    Thomas Peter

    2011-07-01

    Full Text Available Abstract Background Intramuscular pethidine is routinely used throughout the UK for labour analgesia. Studies have suggested that pethidine provides little pain relief in labour and has a number of side effects affecting mother and neonate. It can cause nausea, vomiting and dysphoria in mothers and can cause reduced fetal heart rate variability and accelerations. Neonatal effects include respiratory depression and impaired feeding. There are few large studies comparing the relative side effects and efficacy of different opioids in labour. A small trial comparing intramuscular pethidine with diamorphine, showed diamorphine to have some benefits over pethidine when used for labour analgesia but the study did not investigate the adverse effects of either opioid. Methods The Intramuscular Diamorphine versus Intramuscular Pethidine (IDvIP trial is a randomised double-blind two centre controlled trial comparing intramuscular diamorphine and pethidine regarding their analgesic efficacy in labour and their side effects in mother, fetus and neonate. Information about the trial will be provided to women in the antenatal period or in early labour. Consent and recruitment to the trial will be obtained when the mother requests opioid analgesia. The sample size requirement is 406 women with data on primary outcomes. The maternal primary outcomes are pain relief during the first 3 hours after trial analgesia and specifically pain relief after 60 minutes. The neonatal primary outcomes are need for resuscitation and Apgar Score Discussion If the trial demonstrates that diamorphine provides better analgesia with fewer side effects in mother and neonate this could lead to a change in national practice and result in diamorphine becoming the preferred intramuscular opioid for analgesia in labour. Trial Registration ISRCTN14898678 Eudra No: 2006-003250-18, REC Reference No: 06/Q1702/95, MHRA Authorisation No: 1443/0001/001-0001, NIHR UKCRN reference 6895, RfPB grant

  10. The effect of TCM acupuncture on hot flushes among menopausal women (ACUFLASH study: A study protocol of an ongoing multi-centre randomised controlled clinical trial

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    Borud Einar K

    2007-02-01

    Full Text Available Abstract Background After menopause, 10–20% of all women have nearly intolerable hot flushes. Long term use of hormone replacement therapy involves a health risk, and many women seek alternative strategies to relieve climacteric complaints. Acupuncture is one of the most frequently used complementary therapies in Norway. We designed a study to evaluate whether Traditional Chinese Medicine acupuncture-care together with self-care is more effective than self-care alone to relieve climacteric complaints. Methods/Design The study is a multi-centre pragmatic randomised controlled trial with two parallel arms. Participants are postmenopausal women who document ≥7 flushes/24 hours and who are not using hormone replacement therapy or other medication that may influence flushes. According to power calculations 200 women are needed to detect a 50% reduction in flushes, and altogether 286 women will be recruited to allow for a 30% dropout rate. The treatment group receives 10 sessions of Traditional Chinese Medicine acupuncture-care and self-care; the control group will engage in self-care only. A team of experienced Traditional Chinese Medicine acupuncturists give acupuncture treatments. Discussion The study tests acupuncture as a complete treatment package including the therapeutic relationship and expectation. The intervention period lasts for 12 weeks, with follow up at 6 and 12 months. Primary endpoint is change in daily hot flush frequency in the two groups from baseline to 12 weeks; secondary endpoint is health related quality of life, assessed by the Women's Health Questionnaire. We also collect data on Traditional Chinese Medicine diagnoses, and we examine treatment experiences using a qualitative approach. Finally we measure biological variables, to examine potential mechanisms for the effect of acupuncture. The study is funded by The Research Council of Norway.

  11. Discontinuing financial incentives for adherence to antipsychotic depot medication: long-term outcomes of a cluster randomised controlled trial

    Science.gov (United States)

    Priebe, Stefan; Bremner, Stephen A; Pavlickova, Hana

    2016-01-01

    Objectives In a cluster randomised controlled trial, offering financial incentives improved adherence to antipsychotic depot medication over a 1-year period. Yet, it is unknown whether this positive effect is sustained once the incentives stop. Methods and analyses Patients in the intervention and control group were followed up for 2 years after the intervention. Primary and secondary outcomes were assessed at 6 months and 24 months post intervention. Assessments were conducted between September 2011 and November 2014. Results After the intervention period, intervention and control groups did not show any statistically significant differences in adherence, neither in the first 6 months (71% and 77%, respectively) nor in the following 18 months (68%, 74%). There were no statistically significant differences in secondary outcomes, that is, adherence ≥95% and untoward incidents either. Conclusions It may be concluded that incentives to improve adherence to antipsychotic maintenance medication are effective only for as long as they are provided. Once they are stopped, adherence returns to approximately baseline level with no sustained benefit. Trial registration number ISRCTN77769281; Results. PMID:27655261

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

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    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. Predictors of primary care referrals to a vascular disease prevention lifestyle program among participants in a cluster randomised trial

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    Passey Megan E

    2012-08-01

    Full Text Available Abstract Background Cardiovascular disease accounts for a large burden of disease, but is amenable to prevention through lifestyle modification. This paper examines patient and practice predictors of referral to a lifestyle modification program (LMP offered as part of a cluster randomised controlled trial (RCT of prevention of vascular disease in primary care. Methods Data from the intervention arm of a cluster RCT which recruited 36 practices through two rural and three urban primary care organisations were used. In each practice, 160 eligible high risk patients were invited to participate. Practices were randomly allocated to intervention or control groups. Intervention practice staff were trained in screening, motivational interviewing and counselling and encouraged to refer high risk patients to a LMP involving individual and group sessions. Data include patient surveys; clinical audit; practice survey on capacity for preventive care; referral records from the LMP. Predictors of referral were examined using multi-level logistic regression modelling after adjustment for confounding factors. Results Of 301 eligible patients, 190 (63.1% were referred to the LMP. Independent predictors of referral were baseline BMI ≥ 25 (OR 2.87 95%CI:1.10, 7.47, physical inactivity (OR 2.90 95%CI:1.36,6.14, contemplation/preparation/action stage of change for physical activity (OR 2.75 95%CI:1.07, 7.03, rural location (OR 12.50 95%CI:1.43, 109.7 and smaller practice size (1–3 GPs (OR 16.05 95%CI:2.74, 94.24. Conclusions Providing a well-structured evidence-based lifestyle intervention, free of charge to patients, with coordination and support for referral processes resulted in over 60% of participating high risk patients being referred for disease prevention. Contrary to expectations, referrals were more frequent from rural and smaller practices suggesting that these practices may be more ready to engage with these programs. Trial registration ACTRN

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

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    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

  15. Hand sanitisers for reducing illness absences in primary school children in New Zealand: a cluster randomised controlled trial study protocol

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    Poore Marion R

    2010-01-01

    Full Text Available Abstract Background New Zealand has relatively high rates of morbidity and mortality from infectious disease compared with other OECD countries, with infectious disease being more prevalent in children compared with others in the population. Consequences of infectious disease in children may have significant economic and social impact beyond the direct effects of the disease on the health of the child; including absence from school, transmission of infectious disease to other pupils, staff, and family members, and time off work for parents/guardians. Reduction of the transmission of infectious disease between children at schools could be an effective way of reducing the community incidence of infectious disease. Alcohol based no-rinse hand sanitisers provide an alternative hand cleaning technology, for which there is some evidence that they may be effective in achieving this. However, very few studies have investigated the effectiveness of hand sanitisers, and importantly, the potential wider economic implications of this intervention have not been established. Aims The primary objective of this trial is to establish if the provision of hand sanitisers in primary schools in the South Island of New Zealand, in addition to an education session on hand hygiene, reduces the incidence rate of absence episodes due to illness in children. In addition, the trial will establish the cost-effectiveness and conduct a cost-benefit analysis of the intervention in this setting. Methods/Design A cluster randomised controlled trial will be undertaken to establish the effectiveness and cost-effectiveness of hand sanitisers. Sixty-eight primary schools will be recruited from three regions in the South Island of New Zealand. The schools will be randomised, within region, to receive hand sanitisers and an education session on hand hygiene, or an education session on hand hygiene alone. Fifty pupils from each school in years 1 to 6 (generally aged from 5 to 11 years

  16. Nurse-Led Medicines' Monitoring for Patients with Dementia in Care Homes: A Pragmatic Cohort Stepped Wedge Cluster Randomised Trial.

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    Susan Jordan

    Full Text Available People with dementia are susceptible to adverse drug reactions (ADRs. However, they are not always closely monitored for potential problems relating to their medicines: structured nurse-led ADR Profiles have the potential to address this care gap. We aimed to assess the number and nature of clinical problems identified and addressed and changes in prescribing following introduction of nurse-led medicines' monitoring.Pragmatic cohort stepped-wedge cluster Randomised Controlled Trial (RCT of structured nurse-led medicines' monitoring versus usual care.Five UK private sector care homes.41 service users, taking at least one antipsychotic, antidepressant or anti-epileptic medicine.Nurses completed the West Wales ADR (WWADR Profile for Mental Health Medicines with each participant according to trial step.Problems addressed and changes in medicines prescribed.Information was collected from participants' notes before randomisation and after each of five monthly trial steps. The impact of the Profile on problems found, actions taken and reduction in mental health medicines was explored in multivariate analyses, accounting for data collection step and site.Five of 10 sites and 43 of 49 service users approached participated. Profile administration increased the number of problems addressed from a mean of 6.02 [SD 2.92] to 9.86 [4.48], effect size 3.84, 95% CI 2.57-4.11, P <0.001. For example, pain was more likely to be treated (adjusted Odds Ratio [aOR] 3.84, 1.78-8.30, and more patients attended dentists and opticians (aOR 52.76 [11.80-235.90] and 5.12 [1.45-18.03] respectively. Profile use was associated with reduction in mental health medicines (aOR 4.45, 1.15-17.22.The WWADR Profile for Mental Health Medicines can improve the quality and safety of care, and warrants further investigation as a strategy to mitigate the known adverse effects of prescribed medicines.ISRCTN 48133332.

  17. Efficacy of the FIFA 11+ Warm-Up Programme in Male Youth Football: A Cluster Randomised Controlled Trial

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    Oluwatoyosi B. A. Owoeye

    2014-06-01

    Full Text Available The FIFA 11+ is a structured warm-up programme specially designed to prevent injuries among football players from age 14 years and above. However, studies to prove its efficacy are generally few and it is yet to be tested in male youth footballers and among African players. The purpose of the study was to examine the efficacy of the FIFA 11+ programme in reducing the risk of injuries among male youth football players of the Lagos Junior League. A cluster randomised controlled trial was conducted. All the 20 teams (414 players aged 14 -19 years in the Premier League division were block-randomised into either an intervention (INT or a control (CON group. The INT group performed the FIFA 11+ exercises as warm-up during training sessions and the CON group performed usual warm-up. Participating teams were prospectively followed through an entire league season of 6 months in which they were visited every week to assess injured players for time-loss injuries in both groups. The primary outcomes were any injury to the players, injuries by type of exposure and injuries specific to the lower extremities. The secondary outcomes were injuries reported by body location, aetiology, mechanism and severity. In total, 130 injuries were recorded affecting 104 (25% of the 416 players. Team and player compliance with the INT was 60% and 74% respectively. Based on the primary outcome measures of the study, the FIFA 11+ programme significantly reduced the overall rate of injury in the INT group by 41% [RR = 0.59 (95% CI: 0.40 – 0.86; p = 0.006] and all lower extremity injuries by 48% [RR = 0.52 (95% CI: 0.34 – 0.82; p = 0.004]. However, the rate of injury reduction based on secondary outcomes mostly did not reach the level of statistical significance. The FIFA 11+ programme is effective in reducing the rates of injuries in male youth football players.

  18. Intracluster correlation coefficients and coefficients of variation for perinatal outcomes from five cluster-randomised controlled trials in low and middle-income countries: results and methodological implications

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    Mahapatra Rajendra

    2011-06-01

    Full Text Available Abstract Background Public health interventions are increasingly evaluated using cluster-randomised trials in which groups rather than individuals are allocated randomly to treatment and control arms. Outcomes for individuals within the same cluster are often more correlated than outcomes for individuals in different clusters. This needs to be taken into account in sample size estimations for planned trials, but most estimates of intracluster correlation for perinatal health outcomes come from hospital-based studies and may therefore not reflect outcomes in the community. In this study we report estimates for perinatal health outcomes from community-based trials to help researchers plan future evaluations. Methods We estimated the intracluster correlation and the coefficient of variation for a range of outcomes using data from five community-based cluster randomised controlled trials in three low-income countries: India, Bangladesh and Malawi. We also performed a simulation exercise to investigate the impact of cluster size and number of clusters on the reliability of estimates of the coefficient of variation for rare outcomes. Results Estimates of intracluster correlation for mortality outcomes were lower than those for process outcomes, with narrower confidence intervals throughout for trials with larger numbers of clusters. Estimates of intracluster correlation for maternal mortality were particularly variable with large confidence intervals. Stratified randomisation had the effect of reducing estimates of intracluster correlation. The simulation exercise showed that estimates of intracluster correlation are much less reliable for rare outcomes such as maternal mortality. The size of the cluster had a greater impact than the number of clusters on the reliability of estimates for rare outcomes. Conclusions The breadth of intracluster correlation estimates reported here in terms of outcomes and contexts will help researchers plan future

  19. The Economics of Dementia-Care Mapping in Nursing Homes: A Cluster-Randomised Controlled Trial

    OpenAIRE

    Geertje van de Ven; Irena Draskovic; Elke van Herpen; Koopmans, Raymond T C M; Rogier Donders; Zuidema, Sytse U.; Eddy M M Adang; Vernooij-Dassen, Myrra J. F. J.

    2014-01-01

    BACKGROUND: Dementia-care mapping (DCM) is a cyclic intervention aiming at reducing neuropsychiatric symptoms in people with dementia in nursing homes. Alongside an 18-month cluster-randomized controlled trial in which we studied the effectiveness of DCM on residents and staff outcomes, we investigated differences in costs of care between DCM and usual care in nursing homes. METHODS: Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care hom...

  20. Acute Whiplash Injury Study (AWIS): a protocol for a cluster randomised pilot and feasibility trial of an Active Behavioural Physiotherapy Intervention in an insurance private setting

    Science.gov (United States)

    Wiangkham, Taweewat; Duda, Joan; Haque, M Sayeed; Price, Jonathan; Rushton, Alison

    2016-01-01

    Introduction Whiplash-associated disorder (WAD) causes substantial social and economic burden internationally. Up to 60% of patients with WAD progress to chronicity. Research therefore needs to focus on effective management in the acute stage to prevent the development of chronicity. Approximately 93% of patients are classified as WADII (neck complaint and musculoskeletal sign(s)), and in the UK, most are managed in the private sector. In our recent systematic review, a combination of active and behavioural physiotherapy was identified as potentially effective in the acute stage. An Active Behavioural Physiotherapy Intervention (ABPI) was developed through combining empirical (modified Delphi study) and theoretical (social cognitive theory focusing on self-efficacy) evidence. This pilot and feasibility trial has been designed to inform the design of an adequately powered definitive randomised controlled trial. Methods and analysis Two parallel phases. (1) An external pilot and feasibility cluster randomised double-blind (assessor and participants), parallel two-arm (ABPI vs standard physiotherapy) clinical trial to evaluate procedures and feasibility. Six UK private physiotherapy clinics will be recruited and cluster randomised by a computer-generated randomisation sequence. Sixty participants (30 each arm) will be assessed at recruitment (baseline) and at 3 months postbaseline. The planned primary outcome measure is the neck disability index. (2) An embedded exploratory qualitative study using semistructured indepth interviews (n=3–4 physiotherapists) and a focus group (n=6–8 patients) and entailing the recruitment of purposive samples will explore perceptions of the ABPI. Quantitative data will be analysed descriptively. Qualitative data will be coded and analysed deductively (identify themes) and inductively (identify additional themes). Ethics and dissemination This trial is approved by the University of Birmingham Ethics Committee (ERN_15-0542). Trial

  1. The Effect of Using Assessment Instruments on Substance-abuse Outpatients' Adherence to Treatment: a Multi-centre Randomised Controlled Trial

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    Broekaert Eric

    2011-05-01

    Full Text Available Abstract Background Drop-out is an important problem in the treatment of substance use disorder. The focus of this study was to investigate the effectiveness of within treatment assessment with feedback directly to patients with multiple substance use disorder on outpatient individual treatment adherence. Feedback consisted of personal resources' and readiness to change status and progress that facilitate or hinder change, thereby using graphical representation. Methods Informed consent was obtained from both the control and experimental groups to be involved in research and follow-up. Following Zelen's single consent design, baseline participants (n = 280 were randomised (sample-size-estimation: 80%power, p=.05, 2-sided and treatment consent was obtained from those allocated to the experiment (n = 142. In both groups, equal numbers of patients did not attend sessions after allocation. So, 227 persons were analyzed according to intention-to-treat analysis (ITT: experiment n = 116;control n = 111. Excluding refusals 211 participants remained for per-protocol analysis (PP: experiment n = 100; control n = 111, The study was conducted in five outpatient treatment-centres of a large network (De Sleutel in Belgium. Participants were people with multiple substance use disorder -abuse and dependence- who had asked for treatment and who had been advised to start individual treatment after a standardised admission assessment with the European Addiction Severity Index. The experimental condition consisted of informing the patient about the intervention and of subsequent assessments plus feedback following a protocol within the first seven sessions. Assessments were made with the Readiness to Change Questionnaire and the Personal Resources Diagnostic System. The control group received the usual treatment without within treatment assessment with feedback. The most important outcome measure in this analysis of the study was the level of adherence to treatment

  2. Reminiscence groups for people with dementia and their family carers: pragmatic eight-centre randomised trial of joint reminiscence and maintenance versus usual treatment: a protocol

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    Orrell Martin

    2009-07-01

    Full Text Available Abstract Background The growing number of people with dementia, and the increasing cost of care, provides a major incentive to develop and test methods of supporting them in the community for longer. Most attention has been given to pharmacological interventions, but there is increasing recognition that psychosocial interventions may be equally effective, even preferable where medication has negative side-effects. Reminiscence groups, run by professionals and volunteers, which use photographs, recordings and other objects to trigger personal memories are probably the most popular therapeutic approach to working with people with dementia, but there is little evidence for their effectiveness and cost-effectiveness. The recent inclusion of family carers in groups with people with dementia, notably in our own pilot studies, has generated informal evidence that this joint approach improves relationships between people with dementia and their carers, and benefits both. Design and methods This multi-centre, pragmatic randomised controlled trial (RCT to assess the effectiveness and cost-effectiveness of joint reminiscence groups for people with dementia and their family care-givers has two parallel arms – an intervention group and a control group who receive care as usual. The intervention consists of joint reminiscence groups held weekly for twelve consecutive weeks, followed by monthly maintenance sessions for a further seven months. The primary outcome measures are the quality of life of people with dementia, as assessed by QoL-AD, and their care-givers' mental health as assessed by the GHQ-28. Secondary outcomes include: the autobiographical memories of people with dementia; the quality of the relationship between them and their care-givers; and the levels of depression and anxiety felt by them and their care-giver. Using a 5% significance level, comparison of 200 pairs attending joint reminiscence groups with 200 pairs receiving usual treatment

  3. Pilot study of a cluster randomised trial of a guided e-learning health promotion intervention for managers based on management standards for the improvement of employee well-being and reduction of sickness absence: GEM Study

    OpenAIRE

    Stansfeld, Stephen A; Kerry, Sally; Chandola, Tarani; Russell, Jill; Berney, Lee; Hounsome, Natalia; Lanz, Doris; Costelloe, Céire; Smuk, Melanie; Bhui, Kamaldeep

    2015-01-01

    Objectives To investigate the feasibility of recruitment, adherence and likely effectiveness of an e-learning intervention for managers to improve employees’ well-being and reduce sickness absence. Methods The GEM Study (guided e-learning for managers) was a mixed methods pilot cluster randomised trial. Employees were recruited from four mental health services prior to randomising three services to the intervention and one to no-intervention control. Intervention managers received a facilitat...

  4. Pilot study of a cluster randomised trial of a guided e-learning health promotion intervention for managers based on management standards for the improvement of employee well-being and reduction of sickness absence: GEM Study

    OpenAIRE

    Stansfeld, Stephen A; Kerry, Sally; Chandola, Tarani; Russell, Jill; Berney, Lee; Hounsome, Natalia; Lanz, Doris; Costelloe, Ceire; Smuk, Melanie; Bhui, Khamaldeep

    2015-01-01

    OBJECTIVES: To investigate the feasibility of recruitment, adherence and likely effectiveness of an e-learning intervention for managers to improve employees' well-being and reduce sickness absence. METHODS: The GEM Study (guided e-learning for managers) was a mixed methods pilot cluster randomised trial. Employees were recruited from four mental health services prior to randomising three services to the intervention and one to no-intervention control. Intervention managers rece...

  5. Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial

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    de Kort Nelleke

    2011-08-01

    Full Text Available Abstract Background Low back pain (LBP, with high incidence and prevalence rate, is one of the most common reasons to consult the health system and is responsible for a significant amount of sick leave, leading to high health and social costs. The objective of the study is to assess the cost-effectiveness and cost-utility analysis of a multidisciplinary biopsychosocial educational group intervention (MBEGI of non-specific sub-acute LBP in comparison with the usual care in the working population recruited in primary healthcare centres. Methods/design The study design is a cost-effectiveness and cost-utility analysis of a MBEGI in comparison with the usual care of non-specific sub-acute LBP. Measures on effectiveness and costs of both interventions will be obtained from a cluster randomised controlled clinical trial carried out in 38 Catalan primary health care centres, enrolling 932 patients between 18 and 65 years old with a diagnosis of non-specific sub-acute LBP. Effectiveness measures are: pharmaceutical treatments, work sick leave (% and duration in days, Roland Morris disability, McGill pain intensity, Fear Avoidance Beliefs (FAB and Golberg Questionnaires. Utility measures will be calculated from the SF-12. The analysis will be performed from a social perspective. The temporal horizon is at 3 months (change to chronic LBP and 12 months (evaluate the outcomes at long term. Assessment of outcomes will be blinded and will follow the intention-to-treat principle. Discussion We hope to demonstrate the cost-effectiveness and cost-utility of MBEGI, see an improvement in the patients' quality of life, achieve a reduction in the duration of episodes and the chronicity of non-specific low back pain, and be able to report a decrease in the social costs. If the intervention is cost-effectiveness and cost-utility, it could be applied to Primary Health Care Centres. Trial registration ISRCTN: ISRCTN58719694

  6. Effect of osteosynthesis, primary hemiarthroplasty, and non-surgical management for displaced four-part fractures of the proximal humerus in elderly: a multi-centre, randomised clinical trial

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    Johannsen Hans

    2009-07-01

    Full Text Available Abstract Background Fractures of the proximal humerus are common injuries and account for 4–5 percent of all fractures, second only to hip and wrist fractures. The incidence is positively correlated with age and osteoporosis, and is likely to increase. Displaced four-part fractures are among the most severe injuries, accounting for 2–10 percent of proximal humeral fractures. The optimal intervention is disputed. Two previous randomised trials were very small and involved a noticeable risk of bias, and systematic reviews consequently conclude that there is inadequate basis for evidence-based treatment decisions. We aim to compare the effect of osteosynthesis with angle-stable plate with non-surgical management, and the effect of primary hemiarthroplasty with both osteosynthesis and non-surgical management. Methods/Design We will conduct a randomised, multi-centre, clinical trial including patients from ten national shoulder units within a two-year period. We plan to include 162 patients. A central randomisation unit will allocate patients. All patients will receive a standardised three-month rehabilitation program of supervised physiotherapy regardless of treatment allocation. Patients will be followed at least one year. The primary outcomes will be the overall score on the Constant Disability Scale, and its pain subscale, measured at 12 months. A blinded physiotherapist will carry out the assessments. Other secondary outcomes are Oxford Shoulder Score, and general health status (Short Form-36.

  7. Let’s prevent diabetes: study protocol for a cluster randomised controlled trial of an educational intervention in a multi-ethnic UK population with screen detected impaired glucose regulation

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    Gray Laura J

    2012-05-01

    Full Text Available Abstract Background The prevention of type 2 diabetes is a globally recognised health care priority, but there is a lack of rigorous research investigating optimal methods of translating diabetes prevention programmes, based on the promotion of a healthy lifestyle, into routine primary care. The aim of the study is to establish whether a pragmatic structured education programme targeting lifestyle and behaviour change in conjunction with motivational maintenance via the telephone can reduce the incidence of type 2 diabetes in people with impaired glucose regulation (a composite of impaired glucose tolerance and/or impaired fasting glucose identified through a validated risk score screening programme in primary care. Design Cluster randomised controlled trial undertaken at the level of primary care practices. Follow-up will be conducted at 12, 24 and 36 months. The primary outcome is the incidence of type 2 diabetes. Secondary outcomes include changes in HbA1c, blood glucose levels, cardiovascular risk, the presence of the Metabolic Syndrome and the cost-effectiveness of the intervention. Methods The study consists of screening and intervention phases within 44 general practices coordinated from a single academic research centre. Those at high risk of impaired glucose regulation or type 2 diabetes are identified using a risk score and invited for screening using a 75 g-oral glucose tolerance test. Those with screen detected impaired glucose regulation will be invited to take part in the trial. Practices will be randomised to standard care or the intensive arm. Participants from intensive arm practices will receive a structured education programme with motivational maintenance via the telephone and annual refresher sessions. The study will run from 2009–2014. Discussion This study will provide new evidence surrounding the long-term effectiveness of a diabetes prevention programme conducted within routine primary care in the United Kingdom. Trial

  8. Study protocol: a cluster randomised controlled trial of a school based fruit and vegetable intervention – Project Tomato

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    Conner Mark T

    2009-06-01

    Full Text Available Abstract Background The School Fruit and Vegetable Scheme (SFVS is an important public health intervention. The aim of this scheme is to provide a free piece of fruit and/or vegetable every day for children in Reception to Year 2. When children are no longer eligible for the scheme (from Year 3 their overall fruit and vegetable consumption decreases back to baseline levels. This proposed study aims to design a flexible multi-component intervention for schools to support the maintenance of fruit and vegetable consumption for Year 3 children who are no longer eligible for the scheme. Method This study is a cluster randomised controlled trial of Year 2 classes from 54 primary schools across England. The schools will be randomly allocated into two groups to receive either an active intervention called Project Tomato, to support maintenance of fruit intake in Year 3 children, or a less active intervention (control group, consisting of a 5 A DAY booklet. Children's diets will be analysed using the Child And Diet Evaluation Tool (CADET, and height and weight measurements collected, at baseline (Year 2 and 18 month follow-up (Year 4. The primary outcome will be the ability of the intervention (Project Tomato to maintain consumption of fruit and vegetable portions compared to the control group. Discussion A positive result will identify how fruit and vegetable consumption can be maintained in young children, and will be useful for policies supporting the SFVS. A negative result would be used to inform the research agenda and contribute to redefining future strategies for increasing children's fruit and vegetable consumption. Trial registration Medical Research Council Registry code G0501297

  9. Effects of dementia-care mapping on residents and staff of care homes: a pragmatic cluster-randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Geertje van de Ven

    Full Text Available BACKGROUND: The effectiveness of dementia-care mapping (DCM for institutionalised people with dementia has been demonstrated in an explanatory cluster-randomised controlled trial (cRCT with two DCM researchers carrying out the DCM intervention. In order to be able to inform daily practice, we studied DCM effectiveness in a pragmatic cRCT involving a wide range of care homes with trained nursing staff carrying out the intervention. METHODS: Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training and conducted the 4-months DCM-intervention twice during the study. The primary outcome was agitation, measured with the Cohen-Mansfield agitation inventory (CMAI. The secondary outcomes included residents' neuropsychiatric symptoms (NPSs and quality of life, and staff stress and job satisfaction. The nursing staff made all measurements at baseline and two follow-ups at 4-month intervals. We used linear mixed-effect models to test treatment and time effects. RESULTS: 34 units from 11 care homes, including 434 residents and 382 nursing staff members, were randomly assigned. Ten nurses from the intervention units completed the basic and advanced DCM training. Intention-to-treat analysis showed no statistically significant effect on the CMAI (mean difference between groups 2·4, 95% CI -2·7 to 7·6; p = 0·34. More NPSs were reported in the intervention group than in usual care (p = 0·02. Intervention staff reported fewer negative and more positive emotional reactions during work (p = 0·02. There were no other significant effects. CONCLUSIONS: Our pragmatic findings did not confirm the effect on the primary outcome of agitation in the explanatory study. Perhaps the variability of the extent of implementation of DCM may explain the lack of effect. TRIAL REGISTRATION: Dutch Trials Registry NTR2314.

  10. An education programme to increase general practitioners’ awareness of their patients’ employment: design of a cluster randomised controlled trial

    Science.gov (United States)

    2014-01-01

    Background Work and being able to work are important prerequisites for health and well being. Health problems can have a negative influence on the ability to work and not being able to work can be detrimental for patients’ psychosocial well being. Although GPs are aware of this importance they do not always structurally pay attention to patients’ work during their daily practice. Methods/design To investigate whether GPs can be trained to increase their awareness of work and improve their skills when dealing with work related problems we designed a cluster randomised controlled trial. The intervention in this trial is a tailored training based on the findings of qualitative research with focus groups of GPs. Gender aspects received specific attention in these focus groups. Primary outcome measures are self efficacy of patients concerning return to work, and GPs’ use of ICPC code Z05 (work problems) and registration of patients’ occupation. Secondary outcome measures are work awareness of GPs as perceived by patients, quality of life, health, use of care and illness related costs. A process evaluation will be part of our study. Discussion We investigate a training to increase work awareness among GPs, improve their skills in managing work related problems and structurally register work related data in the EMR. We think this study will make a contribution to better health care for workers by motivating GPs to appreciate their specific needs. It will also add to our knowledge of the complex relationship between gender, work and health. Trial registration Trial registration number: NTR3475 PMID:24507221

  11. Children and youth perceive smoking messages in an unbranded advertisement from a NIKE marketing campaign: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Daniel Mark

    2011-04-01

    Full Text Available Abstract Background How youth perceive marketing messages in sports is poorly understood. We evaluated whether youth perceive that the imagery of a specific sports marketing advertisement contained smoking-related messages. Methods Twenty grade 7 to 11 classes (397 students from two high schools in Montréal, Canada were recruited to participate in a cluster randomised single-blind controlled trial. Classes were randomly allocated to either a NIKE advertisement containing the phrase 'LIGHT IT UP' (n = 205 or to a neutral advertisement with smoking imagery reduced and the phrase replaced by 'GO FOR IT' (n = 192. The NIKE logo was removed from both advertisements. Students responded in class to a questionnaire asking open-ended questions about their perception of the messages in the ad. Reports relating to the appearance and text of the ad, and the product being promoted were evaluated. Results Relative to the neutral ad, more students reported that the phrase 'LIGHT IT UP' was smoking-related (37.6% vs. 0.5% and that other parts of the ad resembled smoking-related products (50.7% vs. 10.4%. The relative risk of students reporting that the NIKE ad promoted cigarettes was 4.41 (95% confidence interval: 2.64-7.36; P Conclusions The unbranded imagery of an advertisement in a specific campaign aimed at promoting NIKE hockey products appears to have contained smoking-related messages. This particular marketing campaign may have promoted smoking. This suggests that the regulation of marketing to youth may need to be more tightly controlled.

  12. Physical activity and health-related quality of life during pregnancy: a secondary analysis of a cluster-randomised trial.

    Science.gov (United States)

    Kolu, Päivi; Raitanen, Jani; Luoto, Riitta

    2014-11-01

    The aim of the study was to evaluate the role of physical activity before and during pregnancy on health-related quality of life (HRQoL). Data from the cluster-randomised gestational diabetes mellitus primary prevention trial conducted in maternity clinics were utilised in a secondary analysis. The cases considered were pregnant women who reported engaging in at least 150 min of moderate-intensity leisure-time physical activity per week (active women) (N = 80), and the controls were women below these recommendations (less active) (N = 258). All participants had at least one risk factor for gestational diabetes mellitus. Their HRQoL was evaluated via the validated generic instrument 15D, with HRQoL at the end of pregnancy examined in relation to changes in physical activity during pregnancy. Logistic regression models addressed age, parity, education, and pre-pregnancy body mass index. At the end of pregnancy, the expected HRQoL was higher (tobit regression coefficient 0.022, 95 % CI 0.003-0.042) among active women than less active women. Active women also had greater mobility (OR 1.98, 95 % CI 1.04-3.78), ability to handle their usual activities (OR 2.22, 95 % CI 1.29-3.81), and vitality (OR 2.08, 95 % CI 1.22-3.54) than did less active women. Active women reported higher-quality sleep (OR 2.11, 95 % CI 1.03-4.30) throughout pregnancy as compared to less active women. Meeting of the physical activity guidelines before pregnancy was associated with better overall HRQoL and components thereof related to physical activity.

  13. Children and youth perceive smoking messages in an unbranded advertisement from a NIKE marketing campaign: a cluster randomised controlled trial

    Science.gov (United States)

    2011-01-01

    Background How youth perceive marketing messages in sports is poorly understood. We evaluated whether youth perceive that the imagery of a specific sports marketing advertisement contained smoking-related messages. Methods Twenty grade 7 to 11 classes (397 students) from two high schools in Montréal, Canada were recruited to participate in a cluster randomised single-blind controlled trial. Classes were randomly allocated to either a NIKE advertisement containing the phrase 'LIGHT IT UP' (n = 205) or to a neutral advertisement with smoking imagery reduced and the phrase replaced by 'GO FOR IT' (n = 192). The NIKE logo was removed from both advertisements. Students responded in class to a questionnaire asking open-ended questions about their perception of the messages in the ad. Reports relating to the appearance and text of the ad, and the product being promoted were evaluated. Results Relative to the neutral ad, more students reported that the phrase 'LIGHT IT UP' was smoking-related (37.6% vs. 0.5%) and that other parts of the ad resembled smoking-related products (50.7% vs. 10.4%). The relative risk of students reporting that the NIKE ad promoted cigarettes was 4.41 (95% confidence interval: 2.64-7.36; P < 0.001). Conclusions The unbranded imagery of an advertisement in a specific campaign aimed at promoting NIKE hockey products appears to have contained smoking-related messages. This particular marketing campaign may have promoted smoking. This suggests that the regulation of marketing to youth may need to be more tightly controlled. PMID:21477307

  14. RADAR – A randomised, multi-centre, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with haemodynamically relevant atherosclerotic renal artery stenosis

    Directory of Open Access Journals (Sweden)

    Hauk Michael

    2009-07-01

    Full Text Available Abstract Background Prospective, international, multi-centre, randomised (1:1 trial to evaluate the clinical impact of percutaneous transluminal renal artery stenting (PTRAS on the impaired renal function measured by the estimated glomerular filtration rate (eGFR in patients with haemodynamically significant atherosclerotic renal artery stenosis. Methods Patients will be randomised to receive either PTRAS using the Dynamic Renal Stent system plus best medical treatment or best medical treatment. Renal stenting will be performed under angiographic imaging. For patients randomised to best medical treatment the degree of stenosis measured by renal duplex sonography (RDS will be confirmed by MR angio or multi-slice CT where possible. Best medical treatment will be initiated at randomisation or post procedure (for PTRAS arm only, and adjusted as needed at all visits. Best medical treatment is defined as optimal drug therapy for control of the major risk factors (blood pressure ≤ 125/80 mmHg, LDL cholesterol ≤ 100 mg/dL, HbA1c ≤ 6.5%. Data recordings include serum creatinine values, eGFR, brain natriuretic peptide, patients' medical history and concomitant medication, clinical events, quality of life questionnaire (SF-12v2™, 24 hour ambulatory blood pressure measurement, renal artery duplex ultrasound and echocardiography. Follow-up intervals are at 2, 6, 12 and 36 months following randomisation. The primary endpoint is the difference between treatments in change of eGFR over 12 months. Major secondary endpoints are technical success, change of renal function based on the eGFR slope change between pre-treatment and post-treatment (i.e. improvement, stabilisation, failure, clinical events overall such as renal or cardiac death, stroke, myocardial infarction, hospitalisation for congestive heart failure, progressive renal insufficiency (i.e. need for dialysis, need of target vessel revascularisation or target lesion revascularisation, change in

  15. WHEDA study: Effectiveness of occupational therapy at home for older people with dementia and their caregivers - the design of a pragmatic randomised controlled trial evaluating a Dutch programme in seven German centres

    Directory of Open Access Journals (Sweden)

    Vernooij-Dassen Myrra

    2009-10-01

    Full Text Available Abstract Background A recent Dutch mono-centre randomised controlled trial has shown that occupational therapy improves daily functioning in dementia. The aim of this present study is to compare the effects of the Dutch community occupational therapy programme with a community occupational therapy consultation on daily functioning in older people with mild or moderate dementia and their primary caregivers in a German multi-centre context. Methods/Design A multi-centre single blind randomised controlled trial design is being used in seven health care centres (neurological, psychiatric and for older people in urban regions. Patients are 1:1 randomised to treatment or control group. Assessors are blind to group assignment and perform measurements on both groups at baseline, directly after intervention at 6 weeks and at 16, 26 and 52 weeks follow-up. A sample of 140 community dwelling older people (aged >65 years with mild or moderate dementia and their primary caregivers is planned. The experimental intervention consists of an evidence-based community occupational therapy programme including 10 sessions occupational therapy at home. The control intervention consists of one community occupational therapy consultation based on information material of the Alzheimer Society. Providers of both interventions are occupational therapists experienced in treatment of cognitively impaired older people and trained in both programmes. 'Community' indicates that occupational therapy intervention occurs in the person's own home. The primary outcome is patients' daily functioning assessed with the performance scale of the Interview for Deterioration in Daily Living Activities in Dementia and video tapes of daily activities rated by external raters blind to group assignment using the Perceive, Recall, Plan and Perform System of Task Analysis. Secondary outcomes are patients' and caregivers' quality of life, mood and satisfaction with treatment; the caregiver

  16. A cluster randomised controlled trial and economic evaluation of a structured training programme for caregivers of inpatients after stroke: the TRACS trial.

    Science.gov (United States)

    Forster, A; Dickerson, J; Young, J; Patel, A; Kalra, L; Nixon, J; Smithard, D; Knapp, M; Holloway, I; Anwar, S; Farrin, A

    2013-01-01

    , mood and cost-effectiveness, with final follow-up at 12 months. RESULTS No differences in primary outcomes were found between the groups at 6 months. Adjusted mean differences were -0.2 points [95% confidence interval (CI) -3.0 to 2.5 points; p = 0.866; intracluster correlation coefficient (ICC) = 0.027] for the patient Nottingham Extended Activities of Daily Living score and 0.5 points (95% CI -1.7 to 2.7 points; p = 0.660; ICC = 0.013) for the Caregiver Burden Scale. Furthermore, no differences were detected in any of the secondary outcomes. Intervention compliance varied across the units. Half of the participating centres had a compliance rating of > 60%. Analysis showed no evidence of higher levels of patient independence or lower levels of caregiver burden in the SRUs with better levels of intervention compliance. The economic evaluation suggests that from a patient and caregiver perspective, health and social care costs, societal costs and outcomes are similar for the intervention and control groups at 6 months, 12 months and over 1 year. CONCLUSIONS We have conducted a robust multicentre, cluster randomised trial, demonstrating for the first time that this methodology is feasible in stroke rehabilitation research. There was no difference between the LSCTC and usual care with respect to improving stroke patients' recovery, reducing caregivers' burden, or improving other physical and psychological outcomes, nor was it cost-effective compared with usual care. Compliance with the intervention varied, but analysis indicated that a dose effect was unlikely. It is possible that the immediate post-stroke period may not be the ideal time for the delivery of structured training. The intervention approach might be more relevant if delivered after discharge by community-based teams. TRIAL REGISTRATION Current Controlled Trials ISRCTN49208824. FUNDING This project was funded by the MRC and is managed by the NIHR (project number 09/800/10) on behalf of the MRC

  17. A cluster-randomised clinical trial comparing two cardiovascular health education strategies in a child population: the Savinghearts project

    Directory of Open Access Journals (Sweden)

    Sánchez-Gómez Luis

    2012-11-01

    Full Text Available Abstract Background This paper describes a methodology for comparing the effects of an eduentertainment strategy involving a music concert, and a participatory class experience involving the description and making of a healthy breakfast, as educational vehicles for delivering obesity-preventing/cardiovascular health messages to children aged 7–8 years. Methods/design This study will involve a cluster-randomised trial with blinded assessment. The study subjects will be children aged 7–8 years of both sexes attending public primary schools in the Madrid Region. The participating schools (n=30 will be randomly assigned to one of two groups: 1 Group MC, in which the children will attend a music concert that delivers obesity-preventing/cardiovascular health messages, or 2 Group HB, in which the children will attend a participatory class providing the same information but involving the description and making of a healthy breakfast. The main outcome measured will be the increase in the number of correct answers scored on a knowledge questionnaire and in an attitudes test administered before and after the above interventions. The secondary outcome recorded will be the reduction in BMI percentile among children deemed overweight/obese prior to the interventions. The required sample size (number of children was calculated for a comparison of proportions with an α of 0.05 and a β of 0.20, assuming that the Group MC subjects would show values for the measured variables at least 10% higher than those recorded for the subjects of Group HB. Corrections were made for the design effect and assuming a loss to follow-up of 10%. The maximum sample size required will be 2107 children. Data will be analysed using summary measurements for each cluster, both for making estimates and for hypothesis testing. All analyses will be made on an intention-to-treat basis. Discussion The intervention providing the best results could be recommended as part of health

  18. A cluster randomised trial of a school-based resilience intervention to decrease tobacco, alcohol and illicit drug use in secondary school students: study protocol

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    Hodder Rebecca K

    2012-11-01

    Full Text Available Abstract Background Whilst schools provide a potentially appropriate setting for preventing substance use among young people, systematic review evidence suggests that past interventions in this setting have demonstrated limited effectiveness in preventing tobacco, alcohol and other drug use. Interventions that adopt a mental wellbeing approach to prevent substance use offer considerable promise and resilience theory provides one method to impact on adolescent mental well-being. The aim of the proposed study is to examine the efficacy of a resilience intervention in decreasing the tobacco, alcohol and illicit drug use of adolescents. Methods A cluster randomised controlled trial with schools as the unit of randomisation will be undertaken. Thirty two schools in disadvantaged areas will be allocated to either an intervention or a control group. A comprehensive resilience intervention will be implemented, inclusive of explicit program adoption strategies. Baseline surveys will be conducted with students in Grade 7 in both groups and again three years later when the student cohort is in Grade 10. The primary outcome measures will include self-reported tobacco, alcohol, marijuana and other illicit drug use. Comparisons will be made post-test between Grade 10 students in intervention and control schools to determine intervention effectiveness across all measures. Discussion To the authors’ knowledge this is the first randomised controlled trial to evaluate the effectiveness of a comprehensive school-based resilience intervention, inclusive of explicit adoption strategies, in decreasing tobacco, alcohol and illicit drug use of adolescents attending disadvantaged secondary schools. Trial registration ACTRN12611000606987

  19. Evaluating a Health Educational First Aid Program for Special Education School Personnel: a Cluster Randomised Trial

    Directory of Open Access Journals (Sweden)

    Marianthi Alexandropoulou

    2013-01-01

    Full Text Available Aim: To evaluate the effectiveness of a health educational first aid program for special education school personnel.Design: Cluster randomized trial using Solomon four group design.Setting: Twenty-four randomly selected special education schools in Attiki, Greece. For conducting the study ethical approval was granted both by the Greek Ministry of Education and the Pedagogic Institution.Method: Schools were randomized in four groups. The two intervention groups consisted of 86 participants and the two control of 94.Results: Knowledge was assessed by a First Aid Questionnaire (Cronbach’s alpha=0.79 employing non parametric tests. Statistical analysis showed significant difference within the four groups. Intervention groups had improved significantly their knowledge showing that the program was effective (Kruskal-Wallis one wayANOVA χ 2=74.383, p<.001 and that they would eventually deal with a threatening situation with right handlings (Kruskal-Wallis one way ANOVA χ 2=74.173, p<.001 Insecurity and doubting in relation to providing first aid were reduced (Kruskal-Wallis one way ANOVA χ2=42.604, p<.001. Intervention groups understood the educational program and acquired a sufficient level of knowledge (Kruskal-Wallis one way ANOVA χ 2=55.256 p<.001.Conclusion: First aid health educational program on the one hand enhanced knowledge and improved skills, but on the other hand training is imperative in regular intervals carried out by trained healthcare professionals.

  20. The long-term effects of a peer-led sex education programme (RIPPLE): a cluster randomised trial in schools in England.

    OpenAIRE

    Stephenson, J.; Strange, V; Allen, E.; Copas, A; Johnson, A.; Bonell, C; Babiker, A.; Oakley, A; RIPPLE Study Team

    2008-01-01

    BACKGROUND: Peer-led sex education is widely believed to be an effective approach to reducing unsafe sex among young people, but reliable evidence from long-term studies is lacking. To assess the effectiveness of one form of school-based peer-led sex education in reducing unintended teenage pregnancy, we did a cluster (school) randomised trial with 7 y of follow-up. METHODS AND FINDINGS: Twenty-seven representative schools in England, with over 9,000 pupils aged 13-14 y at baseline, took part...

  1. The Long-Term Effects of a Peer-Led Sex Education Programme (RIPPLE): A Cluster Randomised Trial in Schools in England

    OpenAIRE

    Stephenson, J.; Strange, V; Allen, E.; Copas, A; Johnson, A.; Bonell, C; Babiker, A.; Oakley, A; Ripple Study Team, The

    2008-01-01

    BackgroundPeer-led sex education is widely believed to be an effective approach to reducing unsafe sex among young people, but reliable evidence from long-term studies is lacking. To assess the effectiveness of one form of school-based peer-led sex education in reducing unintended teenage pregnancy, we did a cluster (school) randomised trial with 7 y of follow-up.Methods and FindingsTwenty-seven representative schools in England, with over 9,000 pupils aged 13-14 y at baseline, took part in t...

  2. Cluster-randomised non-inferiority trial comparing DVD-assisted and traditional genetic counselling in systematic population testing for BRCA1/2 mutations

    OpenAIRE

    Manchanda, R.; Burnell, M.; Loggenberg, K.; Desai, R.; Wardle, J.; Sanderson, S.C.; Gessler, S.; Side, L.; Balogun, N.; Kumar, A.(State University of New York at Buffalo, Buffalo, USA); Dorkins, H.; Wallis, Y; Chapman, C; Tomlinson, I; Taylor, R.

    2016-01-01

    BACKGROUND: Newer approaches to genetic counselling are required for population-based testing. We compare traditional face-to-face genetic counselling with a DVD-assisted approach for population-based BRCA1/2 testing. METHODS: A cluster-randomised non-inferiority trial in the London Ashkenazi Jewish population. INCLUSION CRITERIA: Ashkenazi Jewish men/women >18 years; exclusion criteria: (a) known BRCA1/2 mutation, (b) previous BRCA1/2 testing and (c) first-degree relative of BRCA1/2 carrier....

  3. Integrated primary care for patients with mental and physical multimorbidity: cluster randomised controlled trial of collaborative care for patients with depression comorbid with diabetes or cardiovascular disease

    OpenAIRE

    Chew-Graham, CA

    2015-01-01

    Objective To test the effectiveness of an integrated collaborative care model for people with depression and long term physical conditions. Design Cluster randomised controlled trial. Setting 36 general practices in the north west of England. Participants 387 patients with a record of diabetes or heart disease, or both, who had depressive symptoms (≥10 on patient health questionaire-9 (PHQ-9)) for at least two weeks. Mean age was 58.5 (SD 11.7). Participants reported a mean of 6.2 (SD 3.0) lo...

  4. Life- and person-centred help in Mecklenburg-Western Pomerania, Germany (DelpHi: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Thyrian Jochen

    2012-05-01

    Full Text Available Abstract Background The provision of appropriate medical and nursing care for people with dementia is a major challenge for the healthcare system in Germany. New models of healthcare provision need to be developed, tested and implemented on the population level. Trials in which collaborative care for dementia in the primary care setting were studied have demonstrated its effectiveness. These studies have been conducted in different healthcare systems, however, so it is unclear whether these results extend to the specific context of the German healthcare system. The objective of this population-based intervention trial in the primary care setting is to test the efficacy and efficiency of implementing a subsidiary support system on a population level for persons with dementia who live at home. Methods and study design The study was designed to assemble a general physician-based epidemiological cohort of people above the age of 70 who live at home (DelpHi cohort. These people are screened for eligibility to participate in a trial of dementia care management (DelpHi trial. The trial is a cluster-randomised, controlled intervention trial with two arms (intervention and control designed to test the efficacy and efficiency of implementing a subsidiary support system for persons with dementia who live at home. This subsidiary support system is initiated and coordinated by a dementia care manager: a nurse with dementia-specific qualifications who delivers the intervention according to a systematic, detailed protocol. The primary outcome is quality of life and healthcare for patients with dementia and their caregivers. This is a multidimensional outcome with a focus on four dimensions: (1 quality of life, (2 caregiver burden, (3 behavioural and psychological symptoms of dementia and (4 pharmacotherapy with an antidementia drug and prevention or suspension of potentially inappropriate medication. Secondary outcomes include the assessment of dementia

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

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    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

  6. Effectiveness and cost-effectiveness of an educational intervention for practice teams to deliver problem focused therapy for insomnia: rationale and design of a pilot cluster randomised trial

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    Ørner Roderick

    2009-01-01

    Full Text Available Abstract Background Sleep problems are common, affecting over a third of adults in the United Kingdom and leading to reduced productivity and impaired health-related quality of life. Many of those whose lives are affected seek medical help from primary care. Drug treatment is ineffective long term. Psychological methods for managing sleep problems, including cognitive behavioural therapy for insomnia (CBTi have been shown to be effective and cost effective but have not been widely implemented or evaluated in a general practice setting where they are most likely to be needed and most appropriately delivered. This paper outlines the protocol for a pilot study designed to evaluate the effectiveness and cost-effectiveness of an educational intervention for general practitioners, primary care nurses and other members of the primary care team to deliver problem focused therapy to adult patients presenting with sleep problems due to lifestyle causes, pain or mild to moderate depression or anxiety. Methods and design This will be a pilot cluster randomised controlled trial of a complex intervention. General practices will be randomised to an educational intervention for problem focused therapy which includes a consultation approach comprising careful assessment (using assessment of secondary causes, sleep diaries and severity and use of modified CBTi for insomnia in the consultation compared with usual care (general advice on sleep hygiene and pharmacotherapy with hypnotic drugs. Clinicians randomised to the intervention will receive an educational intervention (2 × 2 hours to implement a complex intervention of problem focused therapy. Clinicians randomised to the control group will receive reinforcement of usual care with sleep hygiene advice. Outcomes will be assessed via self-completion questionnaires and telephone interviews of patients and staff as well as clinical records for interventions and prescribing. Discussion Previous studies in adults

  7. The economics of dementia-care mapping in nursing homes: a cluster-randomised controlled trial.

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    Geertje van de Ven

    Full Text Available BACKGROUND: Dementia-care mapping (DCM is a cyclic intervention aiming at reducing neuropsychiatric symptoms in people with dementia in nursing homes. Alongside an 18-month cluster-randomized controlled trial in which we studied the effectiveness of DCM on residents and staff outcomes, we investigated differences in costs of care between DCM and usual care in nursing homes. METHODS: Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training, a DCM organizational briefing day and conducted the 4-months DCM-intervention twice during the study. A single DCM cycle consists of observation, feedback to the staff, and action plans for the residents. We measured costs related to health care consumption, falls and psychotropic drug use at the resident level and absenteeism at the staff level. Data were extracted from resident files and the nursing home records. Prizes were determined using the Dutch manual of health care cost and the cost prices delivered by a pharmacy and a nursing home. Total costs were evaluated by means of linear mixed-effect models for longitudinal data, with the unit as a random effect to correct for dependencies within units. RESULTS: 34 units from 11 nursing homes, including 318 residents and 376 nursing staff members participated in the cost analyses. Analyses showed no difference in total costs. However certain changes within costs could be noticed. The intervention group showed lower costs associated with outpatient hospital appointments over time (p = 0.05 than the control group. In both groups, the number of falls, costs associated with the elderly-care physician and nurse practitioner increased equally during the study (p<0.02. CONCLUSIONS: DCM is a cost-neutral intervention. It effectively reduces outpatient hospital appointments compared to usual care. Other considerations than costs, such as nursing homes' preferences, may determine whether they

  8. Cluster-randomised trial to evaluate the ‘Change for Life’ mass media/ social marketing campaign in the UK

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    Croker Helen

    2012-06-01

    Full Text Available Abstract Background Social marketing campaigns offer a promising approach to the prevention of childhood obesity. Change4Life (C4L is a national obesity prevention campaign in England. It included mass media coverage aiming to reframe obesity into a health issue relevant to all and provided the opportunity for parents to complete a brief questionnaire (‘How are the Kids’ and receive personalised feedback about their children’s eating and activity. Print and online C4L resources were available with guidance about healthy eating and physical activity. The study aims were to examine the impact of personalised feedback and print material from the C4L campaign on parents’ attitudes and behaviours about their children’s eating and activity in a community-based cluster-randomised controlled trial. Methods Parents of 5–11 year old children were recruited from 40 primary schools across England. Schools were randomised to intervention or control (‘usual care’. Basic demographic data and brief information about their attitudes to their children’s health were collected. Families in intervention schools were mailed the C4L print materials and the ‘How are the Kids’ questionnaire; those returning the questionnaire were sent personalised feedback and others received generic materials. Outcomes included awareness of C4L, attitudes to the behaviours recommended in C4L, parenting behaviours (monitoring and modelling, and child health behaviours (diet, physical activity and television viewing. Follow-up data were collected from parents by postal questionnaire after six months. Qualitative interviews were carried out with a subset of parents (n = 12. Results 3,774 families completed baseline questionnaires and follow-up data were obtained from 1,419 families (37.6%. Awareness was high in both groups at baseline (75%, but increased significantly in the intervention group by follow-up (96% vs. 87%. Few parents (5.2% of the intervention

  9. HST imaging of the dusty filaments and nucleus swirl in NGC4696 at the centre of the Centaurus Cluster

    CERN Document Server

    Fabian, A C; Russell, H R; Pinto, C; Canning, R E A; Salome, P; Sanders, J S; Taylor, G B; Zweibel, E G; Conselice, C J; Combes, F; Crawford, C S; Ferland, G J; Gallagher, J S; Hatch, N A; Johnstone, R M; Reynolds, C S

    2016-01-01

    Narrow-band HST imaging has resolved the detailed internal structure of the 10 kpc diameter H alpha+[NII] emission line nebulosity in NGC4696, the central galaxy in the nearby Centaurus cluster, showing that the dusty, molecular, filaments have a width of about 60pc. Optical morphology and velocity measurements indicate that the filaments are dragged out by the bubbling action of the radio source as part of the AGN feedback cycle. Using the drag force we find that the magnetic field in the filaments is in approximate pressure equipartition with the hot gas. The filamentary nature of the cold gas continues inward, swirling around and within the Bondi accretion radius of the central black hole, revealing the magnetic nature of the gas flows in massive elliptical galaxies. HST imaging resolves the magnetic, dusty, molecular filaments at the centre of the Centaurus cluster to a swirl around and within the Bondi radius.

  10. A cluster randomised trial to assess the impact of clinical pathways on AMI management in rural Australian emergency departments

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    Snow Pamela C

    2009-05-01

    Full Text Available Abstract Background People living in rural Australia are more likely to die in hospital following an acute myocardial infarction than those living in major cities. While several factors, including time taken to access hospital care, contribute to this risk, it is also partially attributable to the lower uptake of evidence-based guidelines for the administration of thrombolytic drugs in rural emergency departments where up to one-third of eligible patients do not receive this life-saving intervention. Clinical pathways have the potential to link evidence to practice by integrating guidelines into local systems, but their impact has been hampered by variable implementation strategies and sub-optimal research designs. The purpose of this study is to determine the impact of a five-step clinical pathways implementation process on the timely and efficient administration of thrombolytic drugs for acute myocardial infarctions managed in rural Australian emergency departments. Methods/Design The design is a two-arm, cluster-randomised trial with rural hospital emergency departments that treat and do not routinely transfer acute myocardial infarction patients. Six rural hospitals in the state of Victoria will participate, with three in the intervention group and three in the control group. Intervention hospitals will participate in a five-step clinical pathway implementation process: engagement of clinicians, pathway development according to local resources and systems, reminders, education, and audit and feedback. Hospitals in the control group will each receive a hard copy of Australian national guidelines for chest pain and acute myocardial infarction management. Each group will include 90 cases to give a power of 80% at 5% significance level for the two primary outcome measures: proportion of those eligible for thrombolysis receiving the drug and time to delivery of thrombolytic drug. Discussion Improved compliance with thrombolytic guidelines via

  11. Target for improvement: a cluster randomised trial of public involvement in quality-indicator prioritisation (intervention development and study protocol

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    Burgers Jako

    2011-05-01

    Full Text Available Abstract Background Public priorities for improvement often differ from those of clinicians and managers. Public involvement has been proposed as a way to bridge the gap between professional and public clinical care priorities but has not been studied in the context of quality-indicator choice. Our objective is to assess the feasibility and impact of public involvement on quality-indicator choice and agreement with public priorities. Methods We will conduct a cluster randomised controlled trial comparing quality-indicator prioritisation with and without public involvement. In preparation for the trial, we developed a 'menu' of quality indicators, based on a systematic review of existing validated indicator sets. Participants (public representatives, clinicians, and managers will be recruited from six participating sites. In intervention sites, public representatives will be involved through direct participation (public representatives, clinicians, and managers will deliberate together to agree on quality-indicator choice and use and consultation (individual public recommendations for improvement will be collected and presented to decision makers. In control sites, only clinicians and managers will take part in the prioritisation process. Data on quality-indicator choice and intended use will be collected. Our primary outcome will compare quality-indicator choice and agreement with public priorities between intervention and control groups. A process evaluation based on direct observation, videorecording, and participants' assessment will be conducted to help explain the study's results. The marginal cost of public involvement will also be assessed. Discussion We identified 801 quality indicators that met our inclusion criteria. An expert panel agreed on a final set of 37 items containing validated quality indicators relevant for chronic disease prevention and management in primary care. We pilot tested our public-involvement intervention with 27

  12. Impact of intermittent screening and treatment for malaria among school children in Kenya: a cluster randomised trial.

    Directory of Open Access Journals (Sweden)

    Katherine E Halliday

    2014-01-01

    Full Text Available BACKGROUND: Improving the health of school-aged children can yield substantial benefits for cognitive development and educational achievement. However, there is limited experimental evidence of the benefits of alternative school-based malaria interventions or how the impacts of interventions vary according to intensity of malaria transmission. We investigated the effect of intermittent screening and treatment (IST for malaria on the health and education of school children in an area of low to moderate malaria transmission. METHODS AND FINDINGS: A cluster randomised trial was implemented with 5,233 children in 101 government primary schools on the south coast of Kenya in 2010-2012. The intervention was delivered to children randomly selected from classes 1 and 5 who were followed up for 24 months. Once a school term, children were screened by public health workers using malaria rapid diagnostic tests (RDTs, and children (with or without malaria symptoms found to be RDT-positive were treated with a six dose regimen of artemether-lumefantrine (AL. Given the nature of the intervention, the trial was not blinded. The primary outcomes were anaemia and sustained attention. Secondary outcomes were malaria parasitaemia and educational achievement. Data were analysed on an intention-to-treat basis. During the intervention period, an average of 88.3% children in intervention schools were screened at each round, of whom 17.5% were RDT-positive. 80.3% of children in the control and 80.2% in the intervention group were followed-up at 24 months. No impact of the malaria IST intervention was observed for prevalence of anaemia at either 12 or 24 months (adjusted risk ratio [Adj.RR]: 1.03, 95% CI 0.93-1.13, p = 0.621 and Adj.RR: 1.00, 95% CI 0.90-1.11, p = 0.953 respectively, or on prevalence of P. falciparum infection or scores of classroom attention. No effect of IST was observed on educational achievement in the older class, but an apparent negative

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

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    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

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

    Directory of Open Access Journals (Sweden)

    Helen Anne Snooks

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

  15. Study protocol: Brief intervention for medication overuse headache - A double-blinded cluster randomised parallel controlled trial in primary care

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    Kristoffersen Espen

    2012-08-01

    Full Text Available Abstract Background Chronic headache (headache ≥ 15 days/month for at least 3 months affects 2–5% of the general population. Medication overuse contributes to the problem. Medication-overuse headache (MOH can be identified by using the Severity of Dependence Scale (SDS. A “brief intervention” scheme (BI has previously been used for detoxification from drug and alcohol overuse in other settings. Short, unstructured, individualised simple information may also be enough to detoxify a large portion of those with MOH. We have adapted the structured (BI scheme to be used for MOH in primary care. Methods/Design A double-blinded cluster randomised parallel controlled trial (RCT of BI vs. business as usual. Intervention will be performed in primary care by GPs trained in BI. Patients with MOH will be identified through a simple screening questionnaire sent to patients on the GPs lists. The BI method involves an approach for identifying patients with high likelihood of MOH using simple questions about headache frequency and the SDS score. Feedback is given to the individual patient on his/her score and consequences this might have regarding the individual risk of medication overuse contributing to their headache. Finally, advice is given regarding measures to be taken, how the patient should proceed and the possible gains for the patient. The participating patients complete a headache diary and receive a clinical interview and neurological examination by a GP experienced in headache diagnostics three months after the intervention. Primary outcomes are number of headache days and number of medication days per month at 3 months. Secondary outcomes include proportions with 25 and 50% improvement at 3 months and maintenance of improvement and quality of life after 12 months. Discussion There is a need for evidence-based and cost-effective strategies for treatment of MOH but so far no consensus has been reached regarding an optimal medication

  16. Formation of a massive black hole in the centre of a dense stellar cluster

    International Nuclear Information System (INIS)

    The evolution of a disc-like subcluster of low-mass stars formed of the gas released in inelastic stellar collisions in a dense stellar cluster is investigated. The subcluster evolution due to elastic and inelastic collisions between disc and cluster stars and of the cluster stars with one another are taken inot consideration. the processes of possible disc stellar mass rise owing to coalescences of disc stars is shown to be unimortant, hence the subcluster stellar mass remains low over the whole period of subcluster evolution, until instability coming. The contraction of self-gravitating subcluster of new stars after the instability moment is considered. It is shown that the dynamical friction can be an important mechanism of angular momentum loss during the subcluster contraction. It is shown that subcluster collapse leads to massive black hole formation, its mass being ε7/12 of the cluster mass (where ε is ellipticity)

  17. Step-wedge cluster-randomised community-based trials: An application to the study of the impact of community health insurance

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    Kynast-Wolf Gisela

    2008-10-01

    Full Text Available Abstract Background We describe a step-wedge cluster-randomised community-based trial which has been conducted since 2003 to accompany the implementation of a community health insurance (CHI scheme in West Africa. The trial aims at overcoming the paucity of evidence-based information on the impact of CHI. Impact is defined in terms of changes in health service utilisation and household protection against the cost of illness. Our exclusive focus on the description and discussion of the methods is justified by the fact that the study relies on a methodology previously applied in the field of disease control, but never in the field of health financing. Methods First, we clarify how clusters were defined both in respect of statistical considerations and of local geographical and socio-cultural concerns. Second, we illustrate how households within clusters were sampled. Third, we expound the data collection process and the survey instruments. Finally, we outline the statistical tools to be applied to estimate the impact of CHI. Conclusion We discuss all design choices both in relation to methodological considerations and to specific ethical and organisational concerns faced in the field. On the basis of the appraisal of our experience, we postulate that conducting relatively sophisticated trials (such as our step-wedge cluster-randomised community-based trial aimed at generating sound public health evidence, is both feasible and valuable also in low income settings. Our work shows that if accurately designed in conjunction with local health authorities, such trials have the potential to generate sound scientific evidence and do not hinder, but at times even facilitate, the implementation of complex health interventions such as CHI.

  18. Decoding X-ray observations from centres of galaxy clusters using MCMC

    Science.gov (United States)

    Lakhchaura, Kiran; Saini, Tarun Deep; Sharma, Prateek

    2016-08-01

    Traditionally the thermodynamic profiles (gas density, temperature, etc.) of galaxy clusters are obtained by assuming spherical symmetry and modelling projected X-ray spectra in each annulus. The outer annuli contribute to the inner ones and their contribution needs to be subtracted to obtain the temperature and density of spherical shells. The usual deprojection methods lead to propagation of errors from outside to in and typically do not model the covariance of parameters in different radial shells. In this paper we describe a method based on a free-form model of clusters with cluster parameters (density, temperature) given in spherical shells, which we jointly forward fit to the X-ray data by constructing a Bayesian posterior probability distribution that we sample using the MCMC technique. By systematically marginalizing over the nuisance outer shells, we estimate the inner entropy profiles of clusters and fit them to various models for a sample of Chandra X-ray observations of 17 clusters. We show that the entropy profiles in almost all of our clusters are best described as cored power laws. A small subsample is found to be either consistent with a power law, or alternatively their cores are not fully resolved (smaller than, or about few kpc). We find marginal evidence for bimodality in the central values of entropy (and cooling time) corresponding to cool-core and non cool-core clusters. The minimum value of the ratio of the cooling time and the free-fall time (min[tcool/tff]; correlation is much weaker with core entropy) is anti-correlated with H α and radio luminosity. H α emitting cold gas is absent in our clusters with min(tcool/tff) ≳ 10. Our lowest core entropies are systematically and substantially lower than the values quoted by the ACCEPT sample.

  19. 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

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    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

  20. Protocol for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study: a cluster randomised controlled trial using ePrescribing data

    Science.gov (United States)

    Guthrie, Bruce; Treweek, Shaun; Petrie, Dennis; Barnett, Karen; Ritchie, Lewis D; Robertson, Chris; Bennie, Marion

    2012-01-01

    Introduction High-risk prescribing in primary care is common and causes considerable harm. Feedback interventions to improve care are attractive because they are relatively cheap to widely implement. There is good evidence that feedback has small to moderate effects, but the most recent Cochrane review called for more high-quality, large trials that explicitly test different forms of feedback. Methods and analysis The study is a three-arm cluster-randomised trial with general practices being randomised and outcomes measured at patient level. 262 practices in three Scottish Health Board areas have been randomised (94% of all possible practices). The two active arms receive different forms of prescribing safety data feedback, with rates of high-risk prescribing compared with a ‘usual care’ arm. Sample size estimation used baseline data from participating practices. With 85 practices randomised to each arm, then there is 93% power to detect a 25% difference in the percentage of high-risk prescribing (from 6.1% to 4.5%) between the usual care arm and each intervention arm. The primary outcome is a composite of six high-risk prescribing measures (antipsychotic prescribing to people aged ≥75 years; non-steroidal anti-inflammatory drug (NSAID) prescribing to people aged ≥75 without gastroprotection; NSAID prescribing to people prescribed aspirin/clopidogrel without gastroprotection; NSAID prescribing to people prescribed an ACE inhibitor/angiotensin receptor blocker and a diuretic; NSAID prescription to people prescribed an oral anticoagulant without gastroprotection; aspirin/clopidogrel prescription to people prescribed an oral anticoagulant without gastroprotection). The primary analysis will use multilevel modelling to account for repeated measurement of outcomes in patients clustered within practices. Ethics and dissemination The study was reviewed and approved by the NHS Tayside Committee on Medical Research Ethics B (11/ES/0001). The study will be

  1. The LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre-Operative Physiotherapy) trial: study protocol for a multi-centre randomised controlled trial

    OpenAIRE

    Boden, Ianthe; Browning, Laura; Skinner, Elizabeth H.; Reeve, Julie; El-Ansary, Doa; Robertson, Iain K; Denehy, Linda

    2015-01-01

    Background Post-operative pulmonary complications are a significant problem following open upper abdominal surgery. Preliminary evidence suggests that a single pre-operative physiotherapy education and preparatory lung expansion training session alone may prevent respiratory complications more effectively than supervised post-operative breathing and coughing exercises. However, the evidence is inconclusive due to methodological limitations. No well-designed, adequately powered, randomised con...

  2. Decoding X-ray observations from centres of galaxy clusters using MCMC

    CERN Document Server

    Lakhchaura, Kiran; Sharma, Prateek

    2016-01-01

    Traditionally the thermodynamic profiles (gas density, temperature, etc.) of galaxy clusters are obtained by assuming spherical symmetry and modeling projected X-ray spectra in each annulus. The outer annuli contribute to the inner ones and their contribution needs to be subtracted to obtain the temperature and density of spherical shells. The usual deprojection methods lead to propagation of errors from outside to in and do not model the covariance of parameters in different radial shells. In this paper we describe a method based on a free-form model of clusters with cluster parameters (density, temperature) given in spherical shells, which we {\\it jointly} forward fit to the X-ray data by constructing a Bayesian posterior probability distribution that we sample using the MCMC technique. By systematically marginalising over the nuisance outer shells, we estimate the inner entropy profiles of clusters and fit them to various models for a sample of Chandra X-ray observations of 17 clusters. We show that the en...

  3. Hospital-based cluster randomised controlled trial to assess effects of a multi-faceted programme on influenza vaccine coverage among hospital healthcare workers and nosocomial influenza in the Netherlands, 2009 to 2011

    NARCIS (Netherlands)

    Riphagen-Dalhuisen, J.; Burgerhof, J.G.; Frijstein, G.; van der Geest-Blankert, AD; Danhof-Pont, M.B.; de Jager, H.J.; Bos, A.A.; Smeets, E.E.; de Vries, M.J.; Gallee, P.M.; Hak, E.

    2013-01-01

    Nosocomial influenza is a large burden in hospitals. Despite recommendations from the World Health Organization to vaccinate healthcare workers against influenza, vaccine uptake remains low in most European countries. We performed a pragmatic cluster randomised controlled trial in order to assess th

  4. Hospital-based cluster randomised controlled trial to assess effects of a multi-faceted programme on influenza vaccine coverage among hospital healthcare workers and nosocomial influenza in the Netherlands, 2009 to 2011

    NARCIS (Netherlands)

    J. Riphagen-Dalhuisen; J.G.M. Burgerhof (Johannes G.M.); G. Frijstein; A.D.J. van der Geest-Blankert; M. Danhof-Pont (Marita); H. de Jager (Herbert); A.A. Bos (Antoine); E. Smeets (Ed); M. de Vries (Marjan); P.M.M. Gallee; E. Hak (Eelko)

    2013-01-01

    textabstractNosocomial influenza is a large burden in hospitals. Despite recommendations from the World Health Organization to vaccinate healthcare workers against influenza, vaccine uptake remains low in most European countries. We performed a pragmatic cluster randomised controlled trial in order

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

    Directory of Open Access Journals (Sweden)

    Pearson Melissa

    2011-11-01

    Full Text Available Abstract Background The WHO recognises pesticide poisoning to be the single most important means of suicide globally. Pesticide self-poisoning is a major public health and clinical problem in rural Asia, where it has led to case fatality ratios 20-30 times higher than self-poisoning in the developed world. 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 set up in 44,000 households in the North Central Province, Sri Lanka. A census is being performed, collecting baseline demographic data, socio-economic status, pesticide usage, self-harm and alcohol. Participating villages are then randomised and eligible households in the intervention arm given a lockable safe storage container for agrochemicals. The primary outcome will be incidence of pesticide self-poisoning over three years amongst individuals aged 14 years and over. 217,944 person years of follow-up are required in each arm to detect a 33% reduction in pesticide self-poisoning with 80% power 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 on ClinicalTrials.gov ref: NCT1146496 (http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01146496.

  6. 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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    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. Star-disc interactions in a galactic centre and oblateness of the inner stellar cluster

    CERN Document Server

    Subr, L; Huré, J M

    2004-01-01

    Structure of a quasi-stationary stellar cluster is modelled assuming that it is embedded in the gravitational field of a super-massive black hole. Gradual orbital decay of stellar trajectories is caused by the dissipative interaction with an accretion disc. Gravitational field of the disc is constructed and its effect on the cluster structure is taken into account as an axially symmetric perturbation. Attention is focused on a circumnuclear region (r<10^4 gravitational radii) where the effects of the central black hole and the disc dominate over the influence of an outer galaxy. It is shown how the stellar system becomes gradually flattened towards the disc plane. For certain combinations of the model parameters, a toroidal structure is formed by a fraction of stars. Growing anisotropy of stellar velocities as well as their segregation occur. The mass function of the inner cluster is modified and it progressively departs from the asymptotic form assumed in the outer cluster. A new stationary distribution c...

  8. Geographic Clustering of Cardiometabolic Risk Factors in Metropolitan Centres in France and Australia

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    Catherine Paquet

    2016-05-01

    Full Text Available Understanding how health outcomes are spatially distributed represents a first step in investigating the scale and nature of environmental influences on health and has important implications for statistical power and analytic efficiency. Using Australian and French cohort data, this study aimed to describe and compare the extent of geographic variation, and the implications for analytic efficiency, across geographic units, countries and a range of cardiometabolic parameters (Body Mass Index (BMI waist circumference, blood pressure, resting heart rate, triglycerides, cholesterol, glucose, HbA1c. Geographic clustering was assessed using Intra-Class Correlation (ICC coefficients in biomedical cohorts from Adelaide (Australia, n = 3893 and Paris (France, n = 6430 for eight geographic administrative units. The median ICC was 0.01 suggesting 1% of risk factor variance attributable to variation between geographic units. Clustering differed by cardiometabolic parameters, administrative units and countries and was greatest for BMI and resting heart rate in the French sample, HbA1c in the Australian sample, and for smaller geographic units. Analytic inefficiency due to clustering was greatest for geographic units in which participants were nested in fewer, larger geographic units. Differences observed in geographic clustering across risk factors have implications for choice of geographic unit in sampling and analysis, and highlight potential cross-country differences in the distribution, or role, of environmental features related to cardiometabolic health.

  9. Community mobilisation and health management committee strengthening to increase birth attendance by trained health workers in rural Makwanpur, Nepal: study protocol for a cluster randomised controlled trial

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    Manandhar Dharma

    2011-05-01

    Full Text Available Abstract Background Birth attendance by trained health workers is low in rural Nepal. Local participation in improving health services and increased interaction between health systems and communities may stimulate demand for health services. Significant increases in birth attendance by trained health workers may be affected through community mobilisation by local women's groups and health management committee strengthening. We will test the effect of community mobilisation through women's groups, and health management committee strengthening, on institutional deliveries and home deliveries attended by trained health workers in Makwanpur District. Design Cluster randomised controlled trial involving 43 village development committee clusters. 21 clusters will receive the intervention and 22 clusters will serve as control areas. In intervention areas, Female Community Health Volunteers are supported in convening monthly women's groups. The groups work through an action research cycle in which they consider barriers to institutional delivery, plan and implement strategies to address these barriers with their communities, and evaluate their progress. Health management committees participate in three-day workshops that use appreciative inquiry methods to explore and plan ways to improve maternal and newborn health services. Follow-up meetings are conducted every three months to review progress. Primary outcomes are institutional deliveries and home deliveries conducted by trained health workers. Secondary outcome measures include uptake of antenatal and postnatal care, neonatal mortality and stillbirth rates, and maternal morbidity. Trial registration number ISRCTN99834806

  10. Effect of the Uganda Newborn Study on care-seeking and care practices: a cluster-randomised controlled trial

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    Peter Waiswa

    2015-03-01

    Full Text Available Background: Care for women and babies before, during, and after the time of birth is a sensitive measure of the functionality of any health system. Engaging communities in preventing newborn deaths is a promising strategy to achieve further progress in child survival in sub-Saharan Africa. Objective: To assess the effect of a home visit strategy combined with health facility strengthening on uptake of newborn care-seeking, practices and services, and to link the results to national policy and scale-up in Uganda. Design: The Uganda Newborn Study (UNEST was a two-arm cluster-randomised controlled trial in rural eastern Uganda. In intervention villages volunteer community health workers (CHWs were trained to identify pregnant women and make five home visits (two during pregnancy and three in the first week after birth to offer preventive and promotive care and counselling, with extra visits for sick and small newborns to assess and refer. Health facility strengthening was done in all facilities to improve quality of care. Primary outcomes were coverage of key essential newborn care behaviours (breastfeeding, thermal care, and cord care. Analyses were by intention to treat. This study is registered as a clinical trial, number ISRCTN50321130. Results: The intervention significantly improved essential newborn care practices, although many interventions saw major increases in both arms over the study period. Immediate breastfeeding after birth and exclusive breastfeeding were significantly higher in the intervention arm compared to the control arm (72.6% vs. 66.0%; p=0.016 and 81.8% vs. 75.9%, p=0.042, respectively. Skin-to-skin care immediately after birth and cord cutting with a clean instrument were marginally higher in the intervention arm versus the control arm (80.7% vs. 72.2%; p=0.071 and 88.1% vs. 84.4%; p=0.023, respectively. Half (49.6% of the mothers in the intervention arm waited more than 24 hours to bathe the baby, compared to 35.5% in

  11. Cognitive-behavioural health-promotion intervention increases fruit and vegetable consumption and physical activity among South African adolescents: a cluster-randomised controlled trial.

    Science.gov (United States)

    Jemmott, John B; Jemmott, Loretta S; O'Leary, Ann; Ngwane, Zolani; Icard, Larry; Bellamy, Scarlett; Jones, Shasta; Landis, J Richard; Heeren, G Anita; Tyler, Joanne C; Makiwane, Monde B

    2011-02-01

    Rates of chronic diseases are high among Black South Africans but few studies have tested cognitive-behavioural health-promotion interventions to reduce this problem. We tested the efficacy of such an intervention among adolescents in a cluster-randomised controlled trial. We randomly selected 9 of 17 matched pairs of schools and randomised one school in each pair to the cognitive-behavioural health-promotion intervention designed to encourage health-related behaviours and the other to a human immunodeficiency virus (HIV)/sexually transmitted disease (STD) risk-reduction intervention that served as the control. Interventions were based on social cognitive theory, the theory of planned behaviour and qualitative data from the target population. Data collectors, blind to participants' intervention, administered confidential assessments at baseline and 3, 6 and 12 months post-intervention. Primary outcomes were fruit and vegetable consumption and physical activity. Participants were 1057 grade 6 learners (mean age = 12.4 years), with 96.7% retained at 12-month follow-up. Generalised estimating equations revealed that averaged over the follow-ups, a greater percentage of health-promotion intervention participants than HIV/STD control participants met 5-a-Day fruit and vegetable and physical activity guidelines. The intervention also increased health-promotion knowledge, attitude and intention, but did not decrease substance use or substance-use attitude and intention. The findings suggest that theory based and contextually appropriate interventions may increase health behaviours among young adolescents in sub-Saharan Africa.

  12. Supporting Treatment decision making to Optimise the Prevention of STROKE in Atrial Fibrillation: The STOP STROKE in AF study. Protocol for a cluster randomised controlled trial

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    Gattellari Melina

    2012-07-01

    Full Text Available Abstract Background Suboptimal uptake of anticoagulation for stroke prevention in atrial fibrillation has persisted for over 20 years, despite high-level evidence demonstrating its effectiveness in reducing the risk of fatal and disabling stroke. Methods The STOP STROKE in AF study is a national, cluster randomised controlled trial designed to improve the uptake of anticoagulation in primary care. General practitioners from around Australia enrolling in this ‘distance education’ program are mailed written educational materials, followed by an academic detailing session delivered via telephone by a medical peer, during which participants discuss patient de-identified cases. General practitioners are then randomised to receive written specialist feedback about the patient de-identified cases either before or after completing a three-month posttest audit. Specialist feedback is designed to provide participants with support and confidence to prescribe anticoagulation. The primary outcome is the proportion of patients with atrial fibrillation receiving oral anticoagulation at the time of the posttest audit. Discussion The STOP STROKE in AF study aims to evaluate a feasible intervention via distance education to prevent avoidable stroke due to atrial fibrillation. It provides a systematic test of augmenting academic detailing with expert feedback about patient management. Trial registration Australian Clinical Trials Registry Registration Number: ACTRN12611000076976.

  13. The impact of a disease management program (COACH on the attainment of better cardiovascular risk control in dyslipidaemic patients at primary care centres (The DISSEMINATE Study: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Selvaraj Francis Jude

    2012-10-01

    Full Text Available Abstract Background To evaluate the efficacy of Counselling and Advisory Care for Health (COACH programme in managing dyslipidaemia among primary care practices in Malaysia. This open-label, parallel, randomised controlled trial compared the COACH programme delivered by primary care physicians alone (PCP arm and primary care physicians assisted by nurse educators (PCP-NE arm. Methods This was a multi-centre, open label, randomised trial of a disease management programme (COACH among dyslipidaemic patients in 21 Malaysia primary care practices. The participating centres enrolled 297 treatment naïve subjects who had the primary diagnosis of dyslipidaemia; 149 were randomised to the COACH programme delivered by primary care physicians assisted by nurse educators (PCP-NE and 148 to care provided by primary care physicians (PCP alone. The primary efficacy endpoint was the mean percentage change from baseline LDL-C at week 24 between the 2 study arms. Secondary endpoints included mean percentage change from baseline of lipid profile (TC, LDL-C, HDL-C, TG, TC: HDL ratio, Framingham Cardiovascular Health Risk Score and absolute risk change from baseline in blood pressure parameters at week 24. The study also assessed the sustainability of programme efficacy at week 36. Results Both study arms demonstrated improvement in LDL-C from baseline. The least squares (LS mean change from baseline LDL-C were −30.09% and −27.54% for PCP-NE and PCP respectively. The difference in mean change between groups was 2.55% (p=0.288, with a greater change seen in the PCP-NE arm. Similar observations were made between the study groups in relation to total cholesterol change at week 24. Significant difference in percentage change from baseline of HDL-C were observed between the PCP-NE and PCP groups, 3.01%, 95% CI 0.12-5.90, p=0.041, at week 24. There was no significant difference in lipid outcomes between 2 study groups at week 36 (12 weeks after the programme had

  14. Responding to Young People's Health Risks in Primary Care: A Cluster Randomised Trial of Training Clinicians in Screening and Motivational Interviewing.

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    Lena Sanci

    Full Text Available To evaluate the effectiveness of a complex intervention implementing best practice guidelines recommending clinicians screen and counsel young people across multiple psychosocial risk factors, on clinicians' detection of health risks and patients' risk taking behaviour, compared to a didactic seminar on young people's health.Pragmatic cluster randomised trial where volunteer general practices were stratified by postcode advantage or disadvantage score and billing type (private, free national health, community health centre, then randomised into either intervention or comparison arms using a computer generated random sequence. Three months post-intervention, patients were recruited from all practices post-consultation for a Computer Assisted Telephone Interview and followed up three and 12 months later. Researchers recruiting, consenting and interviewing patients and patients themselves were masked to allocation status; clinicians were not.General practices in metropolitan and rural Victoria, Australia.General practices with at least one interested clinician (general practitioner or nurse and their 14-24 year old patients.This complex intervention was designed using evidence based practice in learning and change in clinician behaviour and general practice systems, and included best practice approaches to motivating change in adolescent risk taking behaviours. The intervention involved training clinicians (nine hours in health risk screening, use of a screening tool and motivational interviewing; training all practice staff (receptionists and clinicians in engaging youth; provision of feedback to clinicians of patients' risk data; and two practice visits to support new screening and referral resources. Comparison clinicians received one didactic educational seminar (three hours on engaging youth and health risk screening.Primary outcomes were patient report of (1 clinician detection of at least one of six health risk behaviours (tobacco, alcohol

  15. Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-speficic sub-acute low back pain in the working population: cluster randomised trial

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    Roura-Olivan Mercè

    2010-01-01

    Full Text Available Abstract Background Non-specific low back pain is a common cause for consultation with the general practitioner, generating increased health and social costs. This study will analyse the effectiveness of a multidisciplinary intervention to reduce disability, severity of pain, anxiety and depression, to improve quality of life and to reduce the incidence of chronic low back pain in the working population with non-specific low back pain, compared to usual clinical care. Methods/Design A Cluster randomised clinical trial will be conducted in 38 Primary Health Care Centres located in Barcelona, Spain and its surrounding areas. The centres are randomly allocated to the multidisciplinary intervention or to usual clinical care. Patients between 18 and 65 years old (n = 932; 466 per arm and with a diagnostic of a non-specific sub-acute low back pain are included. Patients in the intervention group are receiving the recommendations of clinical practice guidelines, in addition to a biopsychosocial multidisciplinary intervention consisting of group educational sessions lasting a total of 10 hours. The main outcome is change in the score in the Roland Morris disability questionnaire at three months after onset of pain. Other outcomes are severity of pain, quality of life, duration of current non-specific low back pain episode, work sick leave and duration, Fear Avoidance Beliefs and Goldberg Questionnaires. Outcomes will be assessed at baseline, 3, 6 and 12 months. Analysis will be by intention to treat. The intervention effect will be assessed through the standard error of measurement and the effect-size. Responsiveness of each scale will be evaluated by standardised response mean and receiver-operating characteristic method. Recovery according to the patient will be used as an external criterion. A multilevel regression will be performed on repeated measures. The time until the current episode of low back pain takes to subside will be analysed by Cox

  16. Effectiveness of a Minimal Intervention for Stress-related mental disorders with Sick leave (MISS; study protocol of a cluster randomised controlled trial in general practice [ISRCTN43779641

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    van Marwijk Harm WJ

    2006-05-01

    Full Text Available Abstract Background The main aims of this paper are to describe the setting and design of a Minimal Intervention in general practice for Stress-related mental disorders in patients on Sick leave (MISS, as well as to ascertain the study complies with the requirements for a cluster randomised controlled trial (RCT. The potential adverse consequences of sick leave due to Stress-related Mental Disorders (SMDs are extensive, but often not recognised. Since most people having SMDs with sick leave consult their general practitioner (GP at an early stage, a tailored intervention given by GPs is justified. We provide a detailed description of the MISS; that is more accurate assessment, education, advice and monitoring to treat SMDs in patients on sick leave. Our hypothesis is that the MISS will be more effective compared to the usual care, in reducing days of sick leave of these patients. Methods The design is a pragmatic RCT. Randomisation is at the level of GPs. They received the MISS-training versus no training, in order to compare the MISS vs. usual care at patient level. Enrolment of patients took place after screening in the source population, that comprised 20–60 year old primary care attendees. Inclusion criteria were: moderately elevated distress levels, having a paid job and sick leave for no longer than three months. There is a one year follow up. The primary outcome measure is lasting full return to work. Reduction of SMD- symptoms is one of the secondary outcome measures. Forty-six GPs and 433 patients agreed to participate. Discussion In our study design, attention is given to the practical application of the requirements for a pragmatic trial. The results of this cluster RCT will add to the evidence about treatment options in general practice for SMDs in patients on sick leave, and might contribute to a new and appropriate guideline. These results will be available at the end of 2006.

  17. 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

    2015-01-01

    Introduction 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? Methods and analysis 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. Ethics and dissemination Study protocols have been reviewed and approved by the ethics committees of the Kenya Medical Research Institute and National Ethics Review Committee, and

  18. 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

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    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

  19. How to build and evaluate an integrated health care system for chronic patients: study design of a clustered randomised controlled trial in rural China

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    Wenxi Tang

    2015-03-01

    Full Text Available Background: While integrated health care system has been proved an effective way to help improving patient health and system efficiency, the exact behaviour model and motivation approach are not so clear in poor rural areas where health human resources and continuous service provision are urgently needed. To gather solid evidence, we initiated a comprehensive intervention project in Qianjiang District, southwest part of rural China in 2012. And after one-year's pilot, we developed an intervention package of team service, comprehensive pathway and prospective- and performance-based payment system. Methods: To testify the potential influence of payment interventions, we use clustered randomised controlled trial, 60 clusters are grouped into two treatment groups and one control group to compare the time and group differences. Difference-in-differences model and structural equation modelling will be used to analyse the intervention effects and pathway. The outcomes are: quality of care, disease burden, supplier cooperative behaviour and patient utilisation behaviour and system efficiency. Repeated multivariate variance analysis will be used to statistically examine the outcome differences. Discussion: This is the first trial of its kind to prove the effects and efficiency of integrated care. Though we adopted randomised controlled trial to gather the highest rank of evidence, still the fully randomisation was hard to realise in health policy reform experiment. To compensate, the designer should take efforts on control for the potential confounders as much as possible. With this trial, we assume the effects will come from: (1 improvement on the quality of life through risk factors control and lifestyles change on patient's behaviours; (2 improvement on quality of care through continuous care and coordinated supplier behaviours; (3 improvement on the system efficiency through active interaction between suppliers and patients. Conclusion

  20. IMPLEmenting a clinical practice guideline for acute low back pain evidence-based manageMENT in general practice (IMPLEMENT: Cluster randomised controlled trial study protocol

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    Francis Jill

    2008-02-01

    Full Text Available Abstract Background Evidence generated from reliable research is not frequently implemented into clinical practice. Evidence-based clinical practice guidelines are a potential vehicle to achieve this. A recent systematic review of implementation strategies of guideline dissemination concluded that there was a lack of evidence regarding effective strategies to promote the uptake of guidelines. Recommendations from this review, and other studies, have suggested the use of interventions that are theoretically based because these may be more effective than those that are not. An evidence-based clinical practice guideline for the management of acute low back pain was recently developed in Australia. This provides an opportunity to develop and test a theory-based implementation intervention for a condition which is common, has a high burden, and for which there is an evidence-practice gap in the primary care setting. Aim This study aims to test the effectiveness of a theory-based intervention for implementing a clinical practice guideline for acute low back pain in general practice in Victoria, Australia. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of patients who are referred for a plain x-ray, and improving mean level of disability for patients three months post-consultation. Methods/Design This study protocol describes the details of a cluster randomised controlled trial. Ninety-two general practices (clusters, which include at least one consenting general practitioner, will be randomised to an intervention or control arm using restricted randomisation. Patients aged 18 years or older who visit a participating practitioner for acute non-specific low back pain of less than three months duration will be eligible for inclusion. An average of twenty-five patients per general practice will be recruited, providing a total of 2,300 patient participants. General practitioners in the

  1. Improving the care for people with acute low-back pain by allied health professionals (the ALIGN trial: A cluster randomised trial protocol

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    Keating Jennifer L

    2010-11-01

    Full Text Available Abstract Background Variability between clinical practice guideline recommendations and actual clinical practice exists in many areas of health care. A 2004 systematic review examining the effectiveness of guideline implementation interventions concluded there was a lack of evidence to support decisions about effective interventions to promote the uptake of guidelines. Further, the review recommended the use of theory in the development of implementation interventions. A clinical practice guideline for the management of acute low-back pain has been developed in Australia (2003. Acute low-back pain is a common condition, has a high burden, and there is some indication of an evidence-practice gap in the allied health setting. This provides an opportunity to develop and test a theory-based implementation intervention which, if effective, may provide benefits for patients with this condition. Aims This study aims to estimate the effectiveness of a theory-based intervention to increase allied health practitioners' (physiotherapists and chiropractors in Victoria, Australia compliance with a clinical practice guideline for acute non-specific low back pain (LBP, compared with providing practitioners with a printed copy of the guideline. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of acute non-specific LBP patients who are either referred for or receive an x-ray, and improving mean level of disability for patients three months post-onset of acute LBP. Methods The design of the study is a cluster randomised trial. Restricted randomisation was used to randomise 210 practices (clusters to an intervention or control group. Practitioners in the control group received a printed copy of the guideline. Practitioners in the intervention group received a theory-based intervention developed to address prospectively identified barriers to practitioner compliance with the guideline. The

  2. How to build and evaluate an integrated health care system for chronic patients: study design of a clustered randomised controlled trial in rural China

    Directory of Open Access Journals (Sweden)

    Wenxi Tang

    2015-03-01

    Full Text Available Background: While integrated health care system has been proved an effective way to help improving patient health and system efficiency, the exact behaviour model and motivation approach are not so clear in poor rural areas where health human resources and continuous service provision are urgently needed. To gather solid evidence, we initiated a comprehensive intervention project in Qianjiang District, southwest part of rural China in 2012. And after one-year's pilot, we developed an intervention package of team service, comprehensive pathway and prospective- and performance-based payment system.Methods: To testify the potential influence of payment interventions, we use clustered randomised controlled trial, 60 clusters are grouped into two treatment groups and one control group to compare the time and group differences. Difference-in-differences model and structural equation modelling will be used to analyse the intervention effects and pathway. The outcomes are: quality of care, disease burden, supplier cooperative behaviour and patient utilisation behaviour and system efficiency. Repeated multivariate variance analysis will be used to statistically examine the outcome differences.Discussion: This is the first trial of its kind to prove the effects and efficiency of integrated care. Though we adopted randomised controlled trial to gather the highest rank of evidence, still the fully randomisation was hard to realise in health policy reform experiment. To compensate, the designer should take efforts on control for the potential confounders as much as possible. With this trial, we assume the effects will come from: (1 improvement on the quality of life through risk factors control and lifestyles change on patient's behaviours; (2 improvement on quality of care through continuous care and coordinated supplier behaviours; (3 improvement on the system efficiency through active interaction between suppliers and patients

  3. The Active for Life Year 5 (AFLY5 school based cluster randomised controlled trial: study protocol for a randomized controlled trial

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    Campbell Rona

    2011-07-01

    Full Text Available Abstract Background Low levels of physical activity, high levels of sedentary behaviour and low levels of fruit and vegetable consumption are common in children and are associated with adverse health outcomes. The aim of this paper is to describe the protocol for a cluster randomised controlled trial (RCT designed to evaluate a school-based intervention that aims to increase levels of physical activity, decrease sedentary behaviour and increase consumption of fruit and vegetables in school children. Methods/design The Active for Life Year 5 (AFLY5 study is a school-based, cluster RCT that targets school children in Year 5 (age 9-10 years. All state junior/primary schools in the area covered by Bristol City and North Somerset Council are invited to participate; special schools are excluded. Eligible schools are randomised to one of two arms: intervention arm (receive the intervention 2011-2012 and control arm (receive the intervention after the final follow-up assessment, 2013-2014. The primary outcomes of the trial are levels of accelerometer assessed physical activity and sedentary behaviour and questionnaire assessed fruit and vegetable consumption. A number of secondary outcomes will also be measured, including body mass index, waist circumference and overweight/obesity. Outcomes will be assessed at baseline (prior to intervention when the children are in Year 4, at the end of intervention 'immediate follow-up' and '12 months long-term' follow-up. We will use random effects linear and logistic regression models to compare outcomes by randomised arm. The economic evaluation from a societal perspective will take the form of a cost consequence analysis. Data from focus groups and interviews with pupils, parents and teachers will be used to increase understanding of how the intervention has any effect and is integrated into normal school activity. Discussion The results of the trial will provide information about the public health effectiveness

  4. IMPLEmenting a clinical practice guideline for acute low back pain evidence-based manageMENT in general practice (IMPLEMENT): Cluster randomised controlled trial study protocol

    Science.gov (United States)

    McKenzie, Joanne E; French, Simon D; O'Connor, Denise A; Grimshaw, Jeremy M; Mortimer, Duncan; Michie, Susan; Francis, Jill; Spike, Neil; Schattner, Peter; Kent, Peter M; Buchbinder, Rachelle; Green, Sally E

    2008-01-01

    Background Evidence generated from reliable research is not frequently implemented into clinical practice. Evidence-based clinical practice guidelines are a potential vehicle to achieve this. A recent systematic review of implementation strategies of guideline dissemination concluded that there was a lack of evidence regarding effective strategies to promote the uptake of guidelines. Recommendations from this review, and other studies, have suggested the use of interventions that are theoretically based because these may be more effective than those that are not. An evidence-based clinical practice guideline for the management of acute low back pain was recently developed in Australia. This provides an opportunity to develop and test a theory-based implementation intervention for a condition which is common, has a high burden, and for which there is an evidence-practice gap in the primary care setting. Aim This study aims to test the effectiveness of a theory-based intervention for implementing a clinical practice guideline for acute low back pain in general practice in Victoria, Australia. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of patients who are referred for a plain x-ray, and improving mean level of disability for patients three months post-consultation. Methods/Design This study protocol describes the details of a cluster randomised controlled trial. Ninety-two general practices (clusters), which include at least one consenting general practitioner, will be randomised to an intervention or control arm using restricted randomisation. Patients aged 18 years or older who visit a participating practitioner for acute non-specific low back pain of less than three months duration will be eligible for inclusion. An average of twenty-five patients per general practice will be recruited, providing a total of 2,300 patient participants. General practitioners in the control arm will receive access

  5. Effectiveness and feasibility of long-lasting insecticide-treated curtains and water container covers for dengue vector control in Colombia: a cluster randomised trial

    Science.gov (United States)

    Quintero, Juliana; García-Betancourt, Tatiana; Cortés, Sebastian; García, Diana; Alcalá, Lucas; González-Uribe, Catalina; Brochero, Helena; Carrasquilla, Gabriel

    2015-01-01

    Background Long-lasting insecticide-treated net (LLIN) window and door curtains alone or in combination with LLIN water container covers were analysed regarding effectiveness in reducing dengue vector density, and feasibility of the intervention. Methods A cluster randomised trial was conducted in an urban area of Colombia comparing 10 randomly selected control and 10 intervention clusters. In control clusters, routine vector control activities were performed. The intervention delivered first, LLIN curtains (from July to August 2013) and secondly, water container covers (from October to March 2014). Cross-sectional entomological surveys were carried out at baseline (February 2013 to June 2013), 9 weeks after the first intervention (August to October 2013), and 4–6 weeks after the second intervention (March to April 2014). Results Curtains were installed in 922 households and water container covers in 303 households. The Breteau index (BI) fell from 14 to 6 in the intervention group and from 8 to 5 in the control group. The additional intervention with LLIN covers for water containers showed a significant reduction in pupae per person index (PPI) (p=0.01). In the intervention group, the PPI index showed a clear decline of 71% compared with 25% in the control group. Costs were high but options for cost savings were identified. Conclusions Short term impact evaluation indicates that the intervention package can reduce dengue vector density but sustained effect will depend on multiple factors. PMID:25604762

  6. Validating the use of Hospital Episode Statistics data and comparison of costing methodologies for economic evaluation: an end-of-life case study from the Cluster randomised triAl of PSA testing for Prostate cancer (CAP)

    Science.gov (United States)

    Thorn, Joanna C; Turner, Emma L; Hounsome, Luke; Walsh, Eleanor; Down, Liz; Verne, Julia; Donovan, Jenny L; Neal, David E; Hamdy, Freddie C; Martin, Richard M; Noble, Sian M

    2016-01-01

    Objectives To evaluate the accuracy of routine data for costing inpatient resource use in a large clinical trial and to investigate costing methodologies. Design Final-year inpatient cost profiles were derived using (1) data extracted from medical records mapped to the National Health Service (NHS) reference costs via service codes and (2) Hospital Episode Statistics (HES) data using NHS reference costs. Trust finance departments were consulted to obtain costs for comparison purposes. Setting 7 UK secondary care centres. Population A subsample of 292 men identified as having died at least a year after being diagnosed with prostate cancer in Cluster randomised triAl of PSA testing for Prostate cancer (CAP), a long-running trial to evaluate the effectiveness and cost-effectiveness of prostate-specific antigen (PSA) testing. Results Both inpatient cost profiles showed a rise in costs in the months leading up to death, and were broadly similar. The difference in mean inpatient costs was £899, with HES data yielding ∼8% lower costs than medical record data (differences compatible with chance, p=0.3). Events were missing from both data sets. 11 men (3.8%) had events identified in HES that were all missing from medical record review, while 7 men (2.4%) had events identified in medical record review that were all missing from HES. The response from finance departments to requests for cost data was poor: only 3 of 7 departments returned adequate data sets within 6 months. Conclusions Using HES routine data coupled with NHS reference costs resulted in mean annual inpatient costs that were very similar to those derived via medical record review; therefore, routinely available data can be used as the primary method of costing resource use in large clinical trials. Neither HES nor medical record review represent gold standards of data collection. Requesting cost data from finance departments is impractical for large clinical trials. Trial registration number ISRCTN92187251

  7. A Randomised Controlled Trial of Two Early Intervention Programs for Young Children with Autism: Centre-Based with Parent Program and Home-Based

    Science.gov (United States)

    Roberts, Jacqueline; Williams, Katrina; Carter, Mark; Evans, David; Parmenter, Trevor; Silove, Natalie; Clark, Trevor; Warren, Anthony

    2011-01-01

    This study compares outcomes of early intervention programs for young children with autism; an individualised home-based program (HB), a small group centre-based program for children combined with a parent training and support group (CB) and a non-treatment comparison group (WL). Outcome measures of interest include social and communication skill…

  8. Building the capacity of family day care educators to promote children's social and emotional wellbeing: an exploratory cluster randomised controlled trial

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    Sims Margaret

    2011-11-01

    Full Text Available Abstract Background Childhood mental health problems are highly prevalent, experienced by one in five children living in socioeconomically disadvantaged families. Although childcare settings, including family day care are ideal to promote children's social and emotional wellbeing at a population level in a sustainable way, family day care educators receive limited training in promoting children's mental health. This study is an exploratory wait-list control cluster randomised controlled trial to test the appropriateness, acceptability, cost, and effectiveness of "Thrive," an intervention program to build the capacity of family day care educators to promote children's social and emotional wellbeing. Thrive aims to increase educators' knowledge, confidence and skills in promoting children's social and emotional wellbeing. Methods/Design This study involves one family day care organisation based in a low socioeconomic area of Melbourne. All family day care educators (term used for registered carers who provide care for children for financial reimbursement in the carers own home are eligible to participate in the study. The clusters for randomisation will be the fieldworkers (n = 5 who each supervise 10-15 educators. The intervention group (field workers and educators will participate in a variety of intervention activities over 12 months, including workshops; activity exchanges with other educators; and focused discussion about children's social and emotional wellbeing during field worker visits. The control group will continue with their normal work practice. The intervention will be delivered to the intervention group and then to the control group after a time delay of 15 months post intervention commencement. A baseline survey will be conducted with all consenting educators and field workers (n = ~70 assessing outcomes at the cluster and individual level. The survey will also be administered at one month, six months and 12 months post

  9. The effect of using an interactive booklet on childhood respiratory tract infections in consultations: Study protocol for a cluster randomised controlled trial in primary care

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    Nuttall Jacqueline

    2008-04-01

    Full Text Available Abstract Background Respiratory tract infections in children result in more primary care consultations than any other acute condition, and are the most common reason for prescribing antibiotics (which are largely unnecessary. About a fifth of children consult again for the same illness episode. Providing parents with written information on respiratory tract infections may result in a reduction in re-consultation rates and antibiotic prescribing for these illnesses. Asking clinicians to provide and discuss the information during the consultation may enhance effectiveness. This paper outlines the protocol for a study designed to evaluate the use of a booklet on respiratory tract infections in children within primary care consultations. Methods/Design This will be a cluster randomised controlled trial. General practices will be randomised to provide parents consulting because their child has an acute respiratory tract infection with either an interactive booklet, or usual care. The booklet provides information on the expected duration of their child's illness, the likely benefits of various treatment options, signs and symptoms that should prompt re-consultation, and symptomatic treatment advice. It has been designed for use within the consultation and aims to enhance communication through the use of specific prompts. Clinicians randomised to using the interactive booklet will receive online training in its use. Outcomes will be assessed via a telephone interview with the parent two weeks after first consulting. The primary outcome will be the proportion of children who re-consult for the same illness episode. Secondary outcomes include: antibiotic use, parental satisfaction and enablement, and illness costs. Consultation rates for respiratory tract infections for the subsequent year will be assessed by a review of practice notes. Discussion Previous studies in adults and children have shown that educational interventions can result in reductions

  10. Evaluation of a theory-informed implementation intervention for the management of acute low back pain in general medical practice: the IMPLEMENT cluster randomised trial.

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    Simon D French

    Full Text Available INTRODUCTION: This cluster randomised trial evaluated an intervention to decrease x-ray referrals and increase giving advice to stay active for people with acute low back pain (LBP in general practice. METHODS: General practices were randomised to either access to a guideline for acute LBP (control or facilitated interactive workshops (intervention. We measured behavioural predictors (e.g. knowledge, attitudes and intentions and fear avoidance beliefs. We were unable to recruit sufficient patients to measure our original primary outcomes so we introduced other outcomes measured at the general practitioner (GP level: behavioural simulation (clinical decision about vignettes and rates of x-ray and CT-scan (medical administrative data. All those not involved in the delivery of the intervention were blinded to allocation. RESULTS: 47 practices (53 GPs were randomised to the control and 45 practices (59 GPs to the intervention. The number of GPs available for analysis at 12 months varied by outcome due to missing confounder information; a minimum of 38 GPs were available from the intervention group, and a minimum of 40 GPs from the control group. For the behavioural constructs, although effect estimates were small, the intervention group GPs had greater intention of practising consistent with the guideline for the clinical behaviour of x-ray referral. For behavioural simulation, intervention group GPs were more likely to adhere to guideline recommendations about x-ray (OR 1.76, 95%CI 1.01, 3.05 and more likely to give advice to stay active (OR 4.49, 95%CI 1.90 to 10.60. Imaging referral was not statistically significantly different between groups and the potential importance of effects was unclear; rate ratio 0.87 (95%CI 0.68, 1.10 for x-ray or CT-scan. CONCLUSIONS: The intervention led to small changes in GP intention to practice in a manner that is consistent with an evidence-based guideline, but it did not result in statistically significant

  11. Protocol for the ‘Virtual Traveller’ cluster-randomised controlled trial: a behaviour change intervention to increase physical activity in primary-school Maths and English lessons

    Science.gov (United States)

    Norris, E; Dunsmuir, S; Duke-Williams, O; Stamatakis, E; Shelton, N

    2016-01-01

    Introduction Physical activity (PA) has been shown to be an important factor for health and educational outcomes in children. However, a large proportion of children's school day is spent in sedentary lesson-time. There is emerging evidence about the effectiveness of physically active lessons: integrating physical movements and educational content in the classroom. ‘Virtual Traveller’ is a novel 6-week intervention of 10-min sessions performed 3 days per week, using classroom interactive whiteboards to integrate movement into primary-school Maths and English teaching. The primary aim of this project is to evaluate the effect of the Virtual Traveller intervention on children's PA, on-task behaviour and student engagement. Methods and analysis This study will be a cluster-randomised controlled trial with a waiting-list control group. Ten year 4 (aged 8–9 years) classes across 10 primary schools will be randomised by class to either the 6-week Virtual Traveller intervention or the waiting-list control group. Data will be collected 5 times: at baseline, at weeks 2 and 4 of the intervention, and 1 week and 3 months postintervention. At baseline, anthropometric measures, 4-day objective PA monitoring (including 2 weekend days; Actigraph accelerometer), PA and on-task behaviour observations and student engagement questionnaires will be performed. All but anthropometric measures will be repeated at all other data collection points. Changes in overall PA levels and levels during different time-periods (eg, lesson-time) will be examined. Changes in on-task behaviour and student engagement between intervention groups will also be examined. Multilevel regression modelling will be used to analyse the data. Process evaluation will be carried out during the intervention period. Ethics and dissemination The results of this study will be disseminated through peer-review publications and conference presentations. Ethical approval was obtained through the University

  12. Evaluation of ‘I-Preventive’: a digital preventive tool for musculoskeletal disorders in computer workers—a pilot cluster randomised trial

    Science.gov (United States)

    Lanhers, C; Pereira, B; Garde, G; Maublant, C; Coudeyre, E

    2016-01-01

    Objectives I-Preventive is a digital preventive tool for musculoskeletal disorders (MSDs) in computer workers. We sought to determine its impact on pain in computer workers with upper limb MSDs and visual discomfort. Methods We conducted a pilot cluster randomised trial in 2 different sites of a tyre factory in France. We randomised 200 employees to either an intervention group (I-Preventive) or control group, each comprising symptomatic and asymptomatic employees. The workers were followed up for 5 months. The main outcome was overall recovery from symptoms following 1 month's intervention based on Nordic-style and eyestrain questionnaires. Results We included 185/200 workers: 96 in the intervention group (mean age 41.8±1.4 years; 88.5% males) and 79 in the control group (mean age 42.9±12.0 years; 94.5% males). The most painful areas (numerical scale ≥2) were the neck (40.0%), upper back (18.8%) and shoulders (15.7%). For the most painful anatomical area, the Nordic score significantly decreased after 1 month in the intervention group (p=0.038); no change was observed in the control group (p=0.59). After 1 month's use, the intervention group reported less pain in the painful area and less visual discomfort symptoms (p=0.02). Adherence to the I-Preventive program was 60%. Conclusions I-Preventive is effective in the short term on musculoskeletal symptoms and visual discomfort by promoting active breaks and eyestrain treatment. This easy-to-use digital tool allows each worker to focus on areas of their choice via personalised, easy exercises that can be performed in the workplace. Trial registration number NCT02350244; Pre-results. PMID:27660316

  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. The BLISS cluster randomised controlled trial of the effect of 'active dissemination of information' on standards of care for premature babies in England (BEADI study protocol [ISRCTN89683698

    Directory of Open Access Journals (Sweden)

    Houston Rosie

    2007-10-01

    Full Text Available Abstract Background Gaps between research knowledge and practice have been consistently reported. Traditional ways of communicating information have limited impact on practice changes. Strategies to disseminate information need to be more interactive and based on techniques reported in systematic reviews of implementation of changes. There is a need for clarification as to which dissemination strategies work best to translate evidence into practice in neonatal units across England. The objective of this trial is to assess whether an innovative active strategy for the dissemination of neonatal research findings, recommendations, and national neonatal guidelines is more likely to lead to changes in policy and practice than the traditional (more passive forms of dissemination in England. Methods/design Cluster randomised controlled trial of all neonatal units in England (randomised by hospital, n = 182 and stratified by neonatal regional networks and neonatal units level of care to assess the relative effectiveness of active dissemination strategies on changes in local policies and practices. Participants will be mainly consultant lead clinicians in each unit. The intervention will be multifaceted using: audit and feedback; educational meetings for local staff (evidence-based lectures on selected topics, interactive workshop to examine current practice and draw up plans for change; and quality improvement and organisational changes methods. Policies and practice outcomes for the babies involved will be collected before and after the intervention. Outcomes will assess all premature babies born in England during a three month period for timing of surfactant administration at birth, temperature control at birth, and resuscitation team (qualification and numbers present at birth. Trial registration Current controlled trials ISRCTN89683698

  15. 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

  16. Helping hands: A cluster randomised trial to evaluate the effectiveness of two different strategies for promoting hand hygiene in hospital nurses

    Directory of Open Access Journals (Sweden)

    Hulscher Marlies

    2011-09-01

    Full Text Available Abstract Background Hand hygiene prescriptions are the most important measure in the prevention of hospital-acquired infections. Yet, compliance rates are generally below 50% of all opportunities for hand hygiene. This study aims at evaluating the short- and long-term effects of two different strategies for promoting hand hygiene in hospital nurses. Methods/design This study is a cluster randomised controlled trial with inpatient wards as the unit of randomisation. Guidelines for hand hygiene will be implemented in this study. Two strategies will be used to improve the adherence to guidelines for hand hygiene. The state-of-the-art strategy is derived from the literature and includes education, reminders, feedback, and targeting adequate products and facilities. The extended strategy also contains activities aimed at influencing social influence in groups and enhancing leadership. The unique contribution of the extended strategy is built upon relevant behavioural science theories. The extended strategy includes all elements of the state-of-the-art strategy supplemented with gaining active commitment and initiative of ward management, modelling by informal leaders at the ward, and setting norms and targets within the team. Data will be collected at four points in time, with six-month intervals. An average of 3,000 opportunities for hand hygiene in approximately 900 nurses will be observed at each time point. Discussion Performing and evaluating an implementation strategy that also targets the social context of teams may considerably add to the general body of knowledge in this field. Results from our study will allow us to draw conclusions on the effects of different strategies for the implementation of hand hygiene guidelines, and based on these results we will be able to define a preferred implementation strategy for hospital based nursing. Trial registration The study is registered as a Clinical Trial in ClinicalTrials.gov, dossier number: NCT

  17. 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

    Background The WHO recognises pesticide poisoning to be the single most important means of suicide globally. Pesticide self-poisoning is a major public health and clinical problem in rural Asia, where it has led to case fatality ratios 20-30 times higher than self-poisoning in the developed world...... a lockable safe storage container for agrochemicals. The primary outcome will be incidence of pesticide self-poisoning over three years amongst individuals aged 14 years and over. 217,944 person years of follow-up are required in each arm to detect a 33% reduction in pesticide self-poisoning with 80% power...... 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...

  18. Benefits and costs of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease - a multi-centre randomised controlled equivalence trial

    OpenAIRE

    Holland, Anne E; Mahal, Ajay; Hill, Catherine J; Lee, Annemarie L; Burge, Angela T; Moore, Rosemary; Nicolson, Caroline; O’Halloran, Paul; Cox, Narelle S.; Lahham, Aroub; Ndongo, Rebecca; Bell, Emily; McDonald, Christine F.

    2013-01-01

    Background Pulmonary rehabilitation is widely advocated for people with chronic obstructive pulmonary disease (COPD) to improve exercise capacity, symptoms and quality of life, however only a minority of individuals with COPD are able to participate. Travel and transport are frequently cited as barriers to uptake of centre-based programs. Other models of pulmonary rehabilitation, including home-based programs, have been proposed in order to improve access to this important treatment. Previous...

  19. Intensification of Development of Mixed Transportation of Freight in Ukraine through Formation of the Network of Transportation and Logistic Centres and Transportation and Logistic Clusters

    Directory of Open Access Journals (Sweden)

    Karpenko Oksana O.

    2013-11-01

    Full Text Available Development of mixed transportation is a prospective direction of development of the transportation system of Ukraine. The article analyses the modern state of development of mixed transportation of freight in Ukraine. The most popular types of combined transportation (refers to multi-modal are container and contrailer trains, which are formed both in Ukraine (Viking and Yaroslav and in other countries, first of all, Belarus (Zubr. One of the reasons of underdevelopment of mixed transportation of freight in Ukraine is absence of a developed network of transportation and logistic centres. The article offers to form a network of transportation and logistic centres in Ukraine as a way of intensification of development of mixed transportations of freight, since they facilitate co-ordination of use of various types of transport and support integrated management of material flows. Transportation and logistic centres should become a start-up complex, around which transportation and logistic clusters would be gradually formed. Transportation and logistic clusters is a new efficient form of network organisation and management of transportation and logistic services and they also ensure growth of efficiency of use of the regional transportation and logistic potential of Ukraine. The article shows prospective supporting transportation and logistic centres and centres of formation of transportation and logistic clusters in the territory of Ukraine. Formation of efficient transportation and logistic system of Ukraine on the basis of a network of transportation and logistic clusters would facilitate entering of Ukraine into the world transportation environment and would allow acceleration of introduction of efficient logistic schemes of freight delivery, in particular, mixed transportation of freight.

  20. The effect of training doctors in communication skills on women’s satisfaction with doctor–woman relationship during labour and delivery: a stepped wedge cluster randomised trial in Damascus

    OpenAIRE

    Bashour, Hyam N; Kanaan, Mona; Kharouf, Mayada H; Abdulsalam, Asmaa A; Tabbaa, Mohammed A; Cheikha, Salah A

    2013-01-01

    Objectives To determine the effect of training residents in interpersonal and communication skills on women’s satisfaction with doctor–woman relationship in labour and delivery rooms. Design A stepped wedge cluster randomised trial. Setting 4 tertiary care teaching maternity hospitals in Damascus, Syria. Participants 2000 women who gave birth to a living baby in the four study hospitals and consented to participate in the intervention took part in the study. Women with difficult labour and hi...

  1. Electronically delivered, multicomponent intervention to reduce unnecessary antibiotic prescribing for respiratory infections in primary care: a cluster randomised trial using electronic health records—REDUCE Trial study original protocol

    OpenAIRE

    Juszczyk, Dorota; Charlton, Judith; McDermott, Lisa; Soames, Jamie; Sultana, Kirin; Ashworth, Mark; Fox, Robin; Hay, Alastair D; Little, Paul; Moore, Michael V.; Yardley, Lucy; Prevost, A Toby; Gulliford, Martin C

    2016-01-01

    Introduction Respiratory tract infections (RTIs) account for about 60% of antibiotics prescribed in primary care. This study aims to test the effectiveness, in a cluster randomised controlled trial, of electronically delivered, multicomponent interventions to reduce unnecessary antibiotic prescribing when patients consult for RTIs in primary care. The research will specifically evaluate the effectiveness of feeding back electronic health records (EHRs) data to general practices.Methods and an...

  2. Mothers' AdvocateS In the Community (MOSAIC)- non-professional mentor support to reduce intimate partner violence and depression in mothers: a cluster randomised trial in primary care

    OpenAIRE

    Gold Lisa; Watson Lyndsey F; Hegarty Kelsey L; Small Rhonda; Taft Angela J; Lumley Judith A

    2011-01-01

    Abstract Background Effective interventions to increase safety and wellbeing of mothers experiencing intimate partner violence (IPV) are scarce. As much attention is focussed on professional intervention, this study aimed to determine the effectiveness of non-professional mentor support in reducing IPV and depression among pregnant and recent mothers experiencing, or at risk of IPV. Methods MOSAIC was a cluster randomised trial in 106 primary care (maternal and child health nurse and general ...

  3. Results of a cluster randomised controlled trial to reduce risky use of alcohol, alcohol-related HIV risks and improve help-seeking behaviour among safety and security employees in the Western Cape, South Africa

    OpenAIRE

    Burnhams, Nadine Harker; London, Leslie; Laubscher, Ria; Nel, Elmarie; Parry, Charles

    2015-01-01

    Objective To test the effectiveness of a programme aimed at reducing the risky use of alcohol and alcohol-related HIV risk and increase help-seeking behaviour among a sample of municipal employees in the Western Cape Province, South Africa. Methods A clustered randomised controlled trial was conducted in 2011–2012 among 325 employees. The eight hour intervention, Team Awareness (TA), addressing behavioural risk among employees was administered to 168 employees in the intervention arm and the ...

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

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    Tim Johansson

    2016-01-01

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

  5. Study Protocol. IDUS – Instrumental delivery & ultrasound. A multi-centre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery

    Directory of Open Access Journals (Sweden)

    Murphy Deirdre J

    2012-09-01

    Full Text Available Abstract Background Instrumental deliveries are commonly performed in the United Kingdom and Ireland, with rates of 12 – 17% in most centres. Knowing the exact position of the fetal head is a pre-requisite for safe instrumental delivery. Traditionally, diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. However, the accuracy of transvaginal digital examination can be unreliable and varies between 20% and 75%. Failure to identify the correct fetal head position increases the likelihood of failed instrumental delivery with the additional morbidity of sequential use of instruments or second stage caesarean section. The use of ultrasound in determining the position of the fetal head has been explored but is not part of routine clinical practice. Methods/Design A multi-centre randomised controlled trial is proposed. The study will take place in two large maternity units in Ireland with a combined annual birth rate of 13,500 deliveries. It will involve 450 nulliparous women undergoing instrumental delivery after 37 weeks gestation. The main outcome measure will be incorrect diagnosis of the fetal head position. A study involving 450 women will have 80% power to detect a 10% difference in the incidence of inaccurate diagnosis of the fetal head position with two-sided 5% alpha. Discussion It is both important and timely to evaluate the use of ultrasound to diagnose the fetal head position prior to instrumental delivery before routine use can be advocated. The overall aim is to reduce the incidence of incorrect diagnosis of the fetal head position prior to instrumental delivery and improve the safety of instrumental deliveries. Trial registration Current Controlled Trials ISRCTN72230496

  6. Study Protocol. IDUS – Instrumental delivery & ultrasound. A multi-centre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery

    Science.gov (United States)

    2012-01-01

    Background Instrumental deliveries are commonly performed in the United Kingdom and Ireland, with rates of 12 – 17% in most centres. Knowing the exact position of the fetal head is a pre-requisite for safe instrumental delivery. Traditionally, diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. However, the accuracy of transvaginal digital examination can be unreliable and varies between 20% and 75%. Failure to identify the correct fetal head position increases the likelihood of failed instrumental delivery with the additional morbidity of sequential use of instruments or second stage caesarean section. The use of ultrasound in determining the position of the fetal head has been explored but is not part of routine clinical practice. Methods/Design A multi-centre randomised controlled trial is proposed. The study will take place in two large maternity units in Ireland with a combined annual birth rate of 13,500 deliveries. It will involve 450 nulliparous women undergoing instrumental delivery after 37 weeks gestation. The main outcome measure will be incorrect diagnosis of the fetal head position. A study involving 450 women will have 80% power to detect a 10% difference in the incidence of inaccurate diagnosis of the fetal head position with two-sided 5% alpha. Discussion It is both important and timely to evaluate the use of ultrasound to diagnose the fetal head position prior to instrumental delivery before routine use can be advocated. The overall aim is to reduce the incidence of incorrect diagnosis of the fetal head position prior to instrumental delivery and improve the safety of instrumental deliveries. Trial registration Current Controlled Trials ISRCTN72230496 PMID:22970933

  7. Study Protocol. IDUS -- Instrumental delivery & ultrasound. A multi-centre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2012-09-13

    AbstractBackgroundInstrumental deliveries are commonly performed in the United Kingdom and Ireland, with rates of 12 – 17% in most centres. Knowing the exact position of the fetal head is a pre-requisite for safe instrumental delivery. Traditionally, diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. However, the accuracy of transvaginal digital examination can be unreliable and varies between 20% and 75%. Failure to identify the correct fetal head position increases the likelihood of failed instrumental delivery with the additional morbidity of sequential use of instruments or second stage caesarean section. The use of ultrasound in determining the position of the fetal head has been explored but is not part of routine clinical practice.Methods\\/DesignA multi-centre randomised controlled trial is proposed. The study will take place in two large maternity units in Ireland with a combined annual birth rate of 13,500 deliveries. It will involve 450 nulliparous women undergoing instrumental delivery after 37 weeks gestation. The main outcome measure will be incorrect diagnosis of the fetal head position. A study involving 450 women will have 80% power to detect a 10% difference in the incidence of inaccurate diagnosis of the fetal head position with two-sided 5% alpha.DiscussionIt is both important and timely to evaluate the use of ultrasound to diagnose the fetal head position prior to instrumental delivery before routine use can be advocated. The overall aim is to reduce the incidence of incorrect diagnosis of the fetal head position prior to instrumental delivery and improve the safety of instrumental deliveries.Trial registrationCurrent Controlled Trials ISRCTN72230496

  8. Improvement of primary care for patients with chronic heart failure: A study protocol for a cluster randomised trial comparing two strategies

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    Wensing Michel

    2011-03-01

    Full Text Available Abstract Background Many patients with chronic heart failure (CHF, a common condition with high morbidity and mortality rates, receive treatment in primary care. To improve the management of CHF in primary care, we developed an implementation programme comprised of educational and organisational components, with support by a practice visitor and focus both on drug treatment and lifestyle advice, and on organisation of care within the practice and collaboration with other healthcare providers. Tailoring has been shown to improve the success of implementation programmes, but little is known about what would be best methods for tailoring, specifically with respect to CHF in primary care. Methods/design We describe the study protocol of a cluster randomised controlled trial to examine the effectiveness of tailoring a CHF implementation programme to general practices compared to a standardised way of delivering a programme. The study population will consist of 60 general practitioners (GPs and the CHF patients they include. GPs are randomised in blocks of four, stratified according to practice size. With a tailored implementation programme GPs prioritise the issues that will form the bases of the support for the practice visits. These may comprise several issues, both educational and organizational. The primary outcome measures are patient's experience of receiving structured primary care for CHF (PACIC, a questionnaire related to the Chronic Care Model, patients' health-related utilities (EQ-5D, and drugs prescriptions using the guideline adherence index. Patients being clustered in practices, multilevel regression analyses will be used to explore the effect of practice size and type of intervention programme. In addition we will examine both changes within groups and differences at follow-up between groups with respect to drug dosages and advice on lifestyle issues. Furthermore, in interviews the feasibility of the programme and goal attainment

  9. Effectiveness and cost-effectiveness of body psychotherapy in the treatment of negative symptoms of schizophrenia – a multi-centre randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Priebe Stefan

    2013-01-01

    Full Text Available Abstract Background Negative symptoms of schizophrenia are frequently associated with poor long term outcomes. Established interventions have little, if any, positive effects on negative symptoms. Arts Therapies such as Body Psychotherapy (BPT have been suggested to reduce negative symptoms, but the existing evidence is limited. In a small exploratory trial a manualised form of group BPT led to significantly lower negative symptom levels both at the end of treatment and at 4 months follow-up as compared to supportive counseling. We designed a large multi-site trial to assess the effectiveness of a manualised BPT intervention in reducing negative symptoms, compared to an active control. Methods/Design In a randomised controlled trial, 256 schizophrenic outpatients with negative symptoms will be randomly allocated either to BPT or Pilates groups. In both conditions, patients will be offered two 90 minutes sessions per week in groups of about 8 patients over a period of 10 weeks. Outcomes are assessed at the end of treatment and at six months follow-up. The primary outcome is severity of negative symptoms, as measured by the Positive and Negative Symptom Scale (PANSS, whilst a range of secondary outcome measures include general psychopathology, social contacts, and quality of life. We will also assess the cost-effectiveness of the intervention. Discussion The study aims to evaluate the effectiveness of a promising form of group therapy which may help alleviate negative symptoms that are associated with unfavourable long-term outcomes and have so far been difficult to treat. If the trial is successful, it will add a new and effective option in the treatment of negative symptoms. Group BPT is manualised, might be attractive to many patients because of its unusual approach, and could potentially be rolled out to services at relatively little additional cost. Trial registration Current Controlled Trials ISRCTN84216587

  10. The nutrition-based comprehensive intervention study on childhood obesity in China (NISCOC): a randomised cluster controlled trial

    OpenAIRE

    Xu Guifa; Ma Jun; Shang Xianwen; Xu Haiquan; Duan Yifan; Hao Linan; Fang Hongyun; Liu Ailing; Zhang Qian; Hu Xiaoqi; Li Yanping; Du Lin; Li Ying; Guo Hongwei; Li Tingyu

    2010-01-01

    Abstract Background Childhood obesity and its related metabolic and psychological abnormalities are becoming serious health problems in China. Effective, feasible and practical interventions should be developed in order to prevent the childhood obesity and its related early onset of clinical cardiovascular diseases. The objective of this paper is to describe the design of a multi-centred random controlled school-based clinical intervention for childhood obesity in China. The secondary objecti...

  11. Role of endothelin in microvascular dysfunction following percutaneous coronary intervention for non-ST elevation acute coronary syndromes: a single-centre randomised controlled trial

    Science.gov (United States)

    Guddeti, Raviteja R; Prasad, Abhiram; Matsuzawa, Yasushi; Aoki, Tatsuo; Rihal, Charanjit; Holmes, David; Best, Patricia; Lennon, Ryan J; Lerman, Lilach O; Lerman, Amir

    2016-01-01

    Objectives Percutaneous coronary intervention (PCI) for acute coronary syndromes frequently fails to restore myocardial perfusion despite establishing epicardial vessel patency. Endothelin-1 (ET-1) is a potent vasoconstrictor, and its expression is increased in atherosclerosis and after PCI. In this study, we aim to define the role of endothelin in regulating coronary microvascular blood flow and myocardial perfusion following PCI in patients with non-ST elevation acute coronary syndromes (NSTACS), by assessing whether adjunctive therapy with a selective endothelin A (ETA) receptor antagonist acutely improves postprocedural coronary microvascular blood flow. Methods In a randomised, double-blinded, placebo-controlled trial, 23 NSTACS patients were enrolled to receive an intracoronary infusion of placebo (n=11) or BQ-123 (n=12) immediately before PCI. Post-PCI coronary microvascular blood flow and myocardial perfusion were assessed by measuring Doppler-derived average peak velocity (APV), and cardiac biomarker levels were quantified. Results Compared with the placebo group, APV was significantly higher in the drug group immediately after PCI (30 (20, 37) vs 19 (9, 26) cm/s; p=0.03). Hyperaemic APV, measured post-adenosine administration, was higher in the BQ-123 group, but the difference did not achieve statistical significance (56 (48, 72) vs 46 (34, 64) cm/s; p=0.090). Maximum coronary flow reserve postprocedure was not different between the two groups (2.1 (1.6, 2.3) vs 2.5 (1.8, 3.0)). Per cent change in creatine kinase isoenzyme MB from the time of PCI to 8 and 16 hours post-PCI was significantly lower in the drug group compared with the placebo group (−17 (−26, −10) vs 26 (−15, 134); p=0.02 and −17 (−38, 14) vs 107 (2, 446); p=0.007, respectively). Conclusions Endothelin is a mediator of microvascular dysfunction during PCI in NSTACS, and adjunctive selective ETA antagonist may augment myocardial perfusion during PCI. Trial registration number

  12. Reducing the Social Gradient in Uptake of the NHS Colorectal Cancer Screening Programme Using a Narrative-Based Information Leaflet: A Cluster-Randomised Trial

    Directory of Open Access Journals (Sweden)

    Lesley M. McGregor

    2016-01-01

    Full Text Available Objective. To test the effectiveness of adding a narrative leaflet to the current information material delivered by the NHS English colorectal cancer (CRC screening programme on reducing socioeconomic inequalities in uptake. Participants. 150,417 adults (59–74 years routinely invited to complete the guaiac Faecal Occult Blood test (gFOBt in March 2013. Design. A cluster randomised controlled trial (ISRCTN74121020 to compare uptake between two arms. The control arm received the standard NHS CRC screening information material (SI and the intervention arm received the standard information plus a supplementary narrative leaflet, which had previously been shown to increase screening intentions (SI + N. Between group comparisons were made for uptake overall and across socioeconomic status (SES. Results. Uptake was 57.7% and did not differ significantly between the two trial arms (SI: 58.5%; SI + N: 56.7%; odds ratio = 0.93; 95% confidence interval: 0.81–1.06; p=0.27. There was no interaction between group and SES quintile (p=0.44. Conclusions. Adding a narrative leaflet to existing information materials does not reduce the SES gradient in uptake. Despite the benefits of using a pragmatic trial design, the need to add to, rather than replace, existing information may have limited the true value of an evidence-based intervention on behaviour.

  13. Reducing the Social Gradient in Uptake of the NHS Colorectal Cancer Screening Programme Using a Narrative-Based Information Leaflet: A Cluster-Randomised Trial.

    Science.gov (United States)

    McGregor, Lesley M; von Wagner, Christian; Atkin, Wendy; Kralj-Hans, Ines; Halloran, Stephen P; Handley, Graham; Logan, Richard F; Rainbow, Sandra; Smith, Steve; Snowball, Julia; Thomas, Mary C; Smith, Samuel G; Vart, Gemma; Howe, Rosemary; Counsell, Nicholas; Hackshaw, Allan; Morris, Stephen; Duffy, Stephen W; Raine, Rosalind; Wardle, Jane

    2016-01-01

    Objective. To test the effectiveness of adding a narrative leaflet to the current information material delivered by the NHS English colorectal cancer (CRC) screening programme on reducing socioeconomic inequalities in uptake. Participants. 150,417 adults (59-74 years) routinely invited to complete the guaiac Faecal Occult Blood test (gFOBt) in March 2013. Design. A cluster randomised controlled trial (ISRCTN74121020) to compare uptake between two arms. The control arm received the standard NHS CRC screening information material (SI) and the intervention arm received the standard information plus a supplementary narrative leaflet, which had previously been shown to increase screening intentions (SI + N). Between group comparisons were made for uptake overall and across socioeconomic status (SES). Results. Uptake was 57.7% and did not differ significantly between the two trial arms (SI: 58.5%; SI + N: 56.7%; odds ratio = 0.93; 95% confidence interval: 0.81-1.06; p = 0.27). There was no interaction between group and SES quintile (p = 0.44). Conclusions. Adding a narrative leaflet to existing information materials does not reduce the SES gradient in uptake. Despite the benefits of using a pragmatic trial design, the need to add to, rather than replace, existing information may have limited the true value of an evidence-based intervention on behaviour. PMID:27069473

  14. Study protocol: the DESPATCH study: Delivering stroke prevention for patients with atrial fibrillation - a cluster randomised controlled trial in primary healthcare

    Directory of Open Access Journals (Sweden)

    Zwar Nicholas

    2011-05-01

    Full Text Available Abstract Background Compelling evidence shows that appropriate use of anticoagulation in patients with nonvalvular atrial fibrillation reduces the risk of ischaemic stroke by 67% and all-cause mortality by 26%. Despite this evidence, anticoagulation is substantially underused, resulting in avoidable fatal and disabling strokes. Methods DESPATCH is a cluster randomised controlled trial with concealed allocation and blinded outcome assessment designed to evaluate a multifaceted and tailored implementation strategy for improving the uptake of anticoagulation in primary care. We have recruited general practices in South Western Sydney, Australia, and randomly allocated practices to receive the DESPATCH intervention or evidence-based guidelines (control. The intervention comprises specialist decisional support via written feedback about patient-specific cases, three academic detailing sessions (delivered via telephone, practice resources, and evidence-based information. Data for outcome assessment will be obtained from a blinded, independent medical record audit. Our primary endpoint is the proportion of nonvalvular atrial fibrillation patients, over 65 years of age, receiving oral anticoagulation at any time during the 12-month posttest period. Discussion Successful translation of evidence into clinical practice can reduce avoidable stroke, death, and disability due to nonvalvular atrial fibrillation. If successful, DESPATCH will inform public policy, providing quality evidence for an effective implementation strategy to improve management of nonvalvular atrial fibrillation, to close an important evidence-practice gap. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12608000074392

  15. Reducing the Social Gradient in Uptake of the NHS Colorectal Cancer Screening Programme Using a Narrative-Based Information Leaflet: A Cluster-Randomised Trial.

    Science.gov (United States)

    McGregor, Lesley M; von Wagner, Christian; Atkin, Wendy; Kralj-Hans, Ines; Halloran, Stephen P; Handley, Graham; Logan, Richard F; Rainbow, Sandra; Smith, Steve; Snowball, Julia; Thomas, Mary C; Smith, Samuel G; Vart, Gemma; Howe, Rosemary; Counsell, Nicholas; Hackshaw, Allan; Morris, Stephen; Duffy, Stephen W; Raine, Rosalind; Wardle, Jane

    2016-01-01

    Objective. To test the effectiveness of adding a narrative leaflet to the current information material delivered by the NHS English colorectal cancer (CRC) screening programme on reducing socioeconomic inequalities in uptake. Participants. 150,417 adults (59-74 years) routinely invited to complete the guaiac Faecal Occult Blood test (gFOBt) in March 2013. Design. A cluster randomised controlled trial (ISRCTN74121020) to compare uptake between two arms. The control arm received the standard NHS CRC screening information material (SI) and the intervention arm received the standard information plus a supplementary narrative leaflet, which had previously been shown to increase screening intentions (SI + N). Between group comparisons were made for uptake overall and across socioeconomic status (SES). Results. Uptake was 57.7% and did not differ significantly between the two trial arms (SI: 58.5%; SI + N: 56.7%; odds ratio = 0.93; 95% confidence interval: 0.81-1.06; p = 0.27). There was no interaction between group and SES quintile (p = 0.44). Conclusions. Adding a narrative leaflet to existing information materials does not reduce the SES gradient in uptake. Despite the benefits of using a pragmatic trial design, the need to add to, rather than replace, existing information may have limited the true value of an evidence-based intervention on behaviour.

  16. A clinically integrated post-graduate training programme in evidence-based medicine versus 'no intervention' for improving disability evaluations: a cluster randomised clinical trial.

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    Rob Kok

    Full Text Available BACKGROUND: Although several studies have shown that teaching EBM is effective in improving knowledge, at present, there is no convincing evidence that teaching EBM also changes professional behaviour in practice. Therefore, the primary aim of this study was to evaluate the effectiveness of a clinically integrated post-graduate training programme in EBM on evidence-based disability evaluation. METHODS AND FINDINGS: In a cluster randomised controlled trial, fifty-four case-based learning groups consisting of 132 physicians and 1680 patients were randomly assigned to the intervention or control groups. A clinically integrated, post-graduate, 5-day training programme in evidence-based medicine, consisting of (home assignments, peer teaching, interactive training in searching databases, lectures and brainstorming sessions was provided to the intervention group. The control group received no training. The primary outcome was evidence-based disability evaluation, as indicated by the frequency in use of evidence of sufficient quality in disability evaluation reports. There are no general EBM behaviour outcome measures available. Therefore, we followed general guidelines for constructing performance indicators and defined an a priori cut-off for determination of sufficient quality as recommended for evaluating EB training. Physicians trained in EBM performed more evidence-based disability evaluations compared to physicians in the control group (difference in absolute proportion 9.7%, 95% CI 3.5 to 15.9. The primary outcome differences between groups remained significant after both cluster-adjusted analysis and additional sensitivity analyses accounting for subjects lost to follow-up. CONCLUSIONS: A EBM programme successfully improved the use of evidence in a non-hospital based medical specialty. Our findings support the general recommendations to use multiple educational methods to change physician behaviour. In addition, it appeared important that the

  17. A cluster-randomised trial of staff education to improve the quality of life of people with dementia living in residential care: the DIRECT study.

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    Christopher Beer

    Full Text Available BACKGROUND: The Dementia In Residential care: EduCation intervention Trial (DIRECT was conducted to determine if delivery of education designed to meet the perceived need of GPs and care staff improves the quality of life of participants with dementia living in residential care. METHODOLOGY/PRINCIPAL FINDINGS: This cluster-randomised controlled trial was conducted in 39 residential aged care facilities in the metropolitan area of Perth, Western Australia. 351 care facility residents aged 65 years and older with Mini-Mental State Examination ≤ 24, their GPs and facility staff participated. Flexible education designed to meet the perceived needs of learners was delivered to GPs and care facility staff in intervention groups. The primary outcome of the study was self-rated quality of life of participants with dementia, measured using the QOL-Alzheimer's Disease Scale (QOL-AD at 4 weeks and 6 months after the conclusion of the intervention. Analysis accounted for the effect of clustering by using multi-level regression analysis. Education of GPs or care facility staff did not affect the primary outcome at either 4 weeks or 6 months. In a post hoc analysis excluding facilities in which fewer than 50% of staff attended an education session, self-rated QOL-AD scores were 6.14 points (adjusted 95%CI 1.14, 11.15 higher at four-week follow-up among residents in facilities randomly assigned to the education intervention. CONCLUSION: The education intervention directed at care facilities or GPs did not improve the quality of life ratings of participants with dementia as a group. This may be explained by the poor adherence to the intervention programme, as participants with dementia living in facilities where staff participated at least minimally seemed to benefit. TRIAL REGISTRATION: ANZCTR.org.au ACTRN12607000417482.

  18. Near-infrared light to aid peripheral intravenous cannulation in children : a cluster randomised clinical trial of three devices

    NARCIS (Netherlands)

    de Graaff, J. C.; Cuper, N. J.; Mungra, R. A. A.; Vlaardingerbroek, K.; Numan, S. C.; Kalkman, C. J.

    2013-01-01

    Intravenous cannulation can be difficult in children. Recently, new devices using near-infrared light to make blood vessels visible have become available. We aimed to evaluate the effectiveness of three such devices in facilitating peripheral intravenous cannulation in children. In this cluster rand

  19. 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

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    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

  20. The Feedback Intervention Trial (FIT--improving hand-hygiene compliance in UK healthcare workers: a stepped wedge cluster randomised controlled trial.

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    Christopher Fuller

    Full Text Available 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;p<0.001 in ITUs but not ACE wards, equivalent to 7-9% absolute increase in compliance. PER-PROTOCOL ANALYSIS FOR IMPLEMENTING WARDS: OR for compliance rose for both ACE (1.67 [1.28-2.22]; p<0.001 & ITUs (2.09 [1.55-2.81]; p<0.001 equating to absolute increases of 10-13% and 13-18% respectively. Fidelity to intervention closely related to compliance on ITUs (OR 1.12 [1.04, 1.20]; p = 0.003 per completed form but not ACE wards. CONCLUSION: Despite difficulties in implementation, intention-to-treat, per-protocol and fidelity to intervention, analyses showed an intervention coupling feedback to

  1. Prevention of recurrent sickness absence among employees with common mental disorders: design of a cluster-randomised controlled trial with cost-benefit and effectiveness evaluation

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    Bültmann Ute

    2010-03-01

    Full Text Available Abstract Background Common mental disorders, such as depression, anxiety disorder, and adjustment disorder, have emerged as a major public and occupational health problem in many countries. These disorders can have severe consequences such as absenteeism and work disability. Different interventions have been developed to improve the return-to-work of employees with common mental disorders, but still a large proportion of employees experiences health and work problems after their return-to-work. For this reason, the SHARP-at work intervention is developed to prevent a relapse of sickness absence among employees who have returned to work after a period of sickness absence because of common mental disorders. We aim to evaluate the effectiveness, cost-benefit and process of the intervention compared to care as usual. Methods/Design The study is designed as a cluster-randomised controlled trial with randomisation at the level of the occupational physician. Employees who have returned to work after a period of sickness absence because of a common mental disorder are included in the study. Employees in the intervention group will receive the SHARP-at work intervention. The intervention focusses on active guidance of employees by occupational physicians during the first weeks of work after sickness absence. Employees in the control group will receive care as usual. Outcomes will be assessed at baseline and at 3, 6, and 12 months follow-up. The primary outcome is cumulative recurrent sickness absence days. Secondary outcome measures are mental health, work functioning, and coping. Adherence to the protocol, communication between stakeholders, and satisfaction with the treatment are the process measures assessed in both study groups. Cost-benefit is calculated from a societal perspective. Finally, prognostic factors for a relapse of sickness absence are investigated. Discussion This study goes beyond return-to-work by focussing on the prevention of

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

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    Elinder Liselotte

    2011-03-01

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

  3. 'Be active, eat right', evaluation of an overweight prevention protocol among 5-year-old children: design of a cluster randomised controlled trial

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    Veldhuis Lydian

    2009-06-01

    Full Text Available Abstract Background The prevalence of overweight and obesity in children has at least doubled in the past 25 years with a major impact on health. In 2005 a prevention protocol was developed applicable within Youth Health Care. This study aims to assess the effects of this protocol on prevalence of overweight and health behaviour among children. Methods and design A cluster randomised controlled trial is conducted among 5-year-old children included by 44 Youth Health Care teams randomised within 9 Municipal Health Services. The teams are randomly allocated to the intervention or control group. The teams measure the weight and height of all children. When a child in the intervention group is detected with overweight according to the international age and gender specific cut-off points of BMI, the prevention protocol is applied. According to this protocol parents of overweight children are invited for up to three counselling sessions during which they receive personal advice about a healthy lifestyle, and are motivated for and assisted in behavioural change. The primary outcome measures are Body Mass Index and waist circumference of the children. Parents will complete questionnaires to assess secondary outcome measures: levels of overweight inducing/reducing behaviours (i.e. being physically active, having breakfast, drinking sweet beverages and watching television/playing computer games, parenting styles, parenting practices, and attitudes of parents regarding these behaviours, health-related quality of life of the children, and possible negative side effects of the prevention protocol. Data will be collected at baseline (when the children are aged 5 years, and after 12 and 24 months of follow-up. Additionally, a process and a cost-effectiveness evaluation will be conducted. Discussion In this study called 'Be active, eat right' we evaluate an overweight prevention protocol for use in the setting of Youth Health Care. It is hypothesized that the

  4. The effectiveness of the Screening Inventory of Psychosocial Problems (SIPP in cancer patients treated with radiotherapy: design of a cluster randomised controlled trial

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    Eekers Daniëlle

    2009-06-01

    Full Text Available Abstract Background The Screening Inventory of Psychosocial Problems (SIPP is a short, validated self-reported questionnaire to identify psychosocial problems in Dutch cancer patients. The one-page 24-item questionnaire assesses physical complaints, psychological complaints and social and sexual problems. Very little is known about the effects of using the SIPP in consultation settings. Our study aims are to test the hypotheses that using the SIPP (a may contribute to adequate referral to relevant psychosocial caregivers, (b should facilitate communication between radiotherapists and cancer patients about psychosocial distress and (c may prevent underdiagnosis of early symptoms reflecting psychosocial problems. This paper presents the design of a cluster randomised controlled trial (CRCT evaluating the effectiveness of using the SIPP in cancer patients treated with radiotherapy. Methods/Design A CRCT is developed using a Solomon four-group design (two intervention and two control groups to evaluate the effects of using the SIPP. Radiotherapists, instead of cancer patients, are randomly allocated to the experimental or control groups. Within these groups, all included cancer patients are randomised into two subgroups: with and without pre-measurement. Self-reported assessments are conducted at four times: a pre-test at baseline before the first consultation and a post-test directly following the first consultation, and three and 12 months after baseline measurement. The primary outcome measures are the number and types of referrals of cancer patients with psychosocial problems to relevant (psychosocial caregivers. The secondary outcome measures are patients' satisfaction with the radiotherapist-patient communication, psychosocial distress and quality of life. Furthermore, a process evaluation will be carried out. Data of the effect-evaluation will be analysed according to the intention-to-treat principle and data regarding the types of referrals

  5. The effectiveness of the Screening Inventory of Psychosocial Problems (SIPP) in cancer patients treated with radiotherapy: design of a cluster randomised controlled trial

    International Nuclear Information System (INIS)

    The Screening Inventory of Psychosocial Problems (SIPP) is a short, validated self-reported questionnaire to identify psychosocial problems in Dutch cancer patients. The one-page 24-item questionnaire assesses physical complaints, psychological complaints and social and sexual problems. Very little is known about the effects of using the SIPP in consultation settings. Our study aims are to test the hypotheses that using the SIPP (a) may contribute to adequate referral to relevant psychosocial caregivers, (b) should facilitate communication between radiotherapists and cancer patients about psychosocial distress and (c) may prevent underdiagnosis of early symptoms reflecting psychosocial problems. This paper presents the design of a cluster randomised controlled trial (CRCT) evaluating the effectiveness of using the SIPP in cancer patients treated with radiotherapy. A CRCT is developed using a Solomon four-group design (two intervention and two control groups) to evaluate the effects of using the SIPP. Radiotherapists, instead of cancer patients, are randomly allocated to the experimental or control groups. Within these groups, all included cancer patients are randomised into two subgroups: with and without pre-measurement. Self-reported assessments are conducted at four times: a pre-test at baseline before the first consultation and a post-test directly following the first consultation, and three and 12 months after baseline measurement. The primary outcome measures are the number and types of referrals of cancer patients with psychosocial problems to relevant (psychosocial) caregivers. The secondary outcome measures are patients' satisfaction with the radiotherapist-patient communication, psychosocial distress and quality of life. Furthermore, a process evaluation will be carried out. Data of the effect-evaluation will be analysed according to the intention-to-treat principle and data regarding the types of referrals to health care providers and patient

  6. The (cost-effectiveness of an individually tailored long-term worksite health promotion programme on physical activity and nutrition: design of a pragmatic cluster randomised controlled trial

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    Burdorf Alex

    2007-09-01

    Full Text Available Abstract Background Cardiovascular disease is the leading cause of disability and mortality in most Western countries. The prevalence of several risk factors, most notably low physical activity and poor nutrition, is very high. Therefore, lifestyle behaviour changes are of great importance. The worksite offers an efficient structure to reach large groups and to make use of a natural social network. This study investigates a worksite health promotion programme with individually tailored advice in physical activity and nutrition and individual counselling to increase compliance with lifestyle recommendations and sustainability of a healthy lifestyle. Methods/Design The study is a pragmatic cluster randomised controlled trial with the worksite as the unit of randomisation. All workers will receive a standard worksite health promotion program. Additionally, the intervention group will receive access to an individual Health Portal consisting of four critical features: a computer-tailored advice, a monitoring function, a personal coach, and opportunities to contact professionals at request. Participants are employees working for companies in the Netherlands, being literate enough to read and understand simple Internet-based messages in the Dutch language. A questionnaire to assess primary outcomes (compliance with national recommendations on physical activity and on fruit and vegetable intake will take place at baseline and after 12 and 24 months. This questionnaire also assesses secondary outcomes including fat intake, self-efficacy and self-perceived barriers on physical activity and fruit and vegetable intake. Other secondary outcomes, including a cardiovascular risk profile and physical fitness, will be measured at baseline and after 24 months. Apart from the effect evaluation, a process evaluation will be carried out to gain insight into participation and adherence to the worksite health promotion programme. A cost-effectiveness analysis and

  7. Prevention through Activity in Kindergarten Trial (PAKT: A cluster randomised controlled trial to assess the effects of an activity intervention in preschool children

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    Lenz Dorothea

    2010-07-01

    Full Text Available Abstract Background Physical activity and motor skills acquisition are of high importance for health-related prevention and a normal development in childhood. However, few intervention studies exist in preschool children focussing on an increase in physical activity and motor skills. Proof of positive effects is available but not consistent. Methods/Design The design, curriculum, and evaluation strategy of a cluster randomised intervention study in preschool children are described in this manuscript. In the Prevention through Activity in Kindergarten Trial (PAKT, 41 of 131 kindergartens of Wuerzburg and Kitzingen, Germany, were randomised into an intervention and a control group by a random number table stratified for the location of the kindergarten in an urban (more than 20.000 inhabitants or rural area. The aims of the intervention were to increase physical activity and motor skills in the participating children, and to reduce health risk factors as well as media use. The intervention was designed to involve children, parents and teachers, and lasted one academic year. It contained daily 30-min sessions of physical education in kindergarten based on a holistic pedagogic approach termed the "early psychomotor education". The sessions were instructed by kindergarten teachers under regular supervision by the research team. Parents were actively involved by physical activity homework cards. The kindergarten teachers were trained in workshops and during the supervision. Assessments were performed at baseline, 3-5 months into the intervention, at the end of the intervention and 2-4 months after the intervention. The primary outcomes of the study are increases in physical activity (accelerometry and in motor skills performance (composite score of obstacle course, standing long jump, balancing on one foot, jumping sidewise to and fro between baseline and the two assessments during the intervention. Secondary outcomes include decreases in body

  8. The long-term effects of a peer-led sex education programme (RIPPLE: a cluster randomised trial in schools in England.

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    Judith Stephenson

    2008-11-01

    Full Text Available BACKGROUND: Peer-led sex education is widely believed to be an effective approach to reducing unsafe sex among young people, but reliable evidence from long-term studies is lacking. To assess the effectiveness of one form of school-based peer-led sex education in reducing unintended teenage pregnancy, we did a cluster (school randomised trial with 7 y of follow-up. METHODS AND FINDINGS: Twenty-seven representative schools in England, with over 9,000 pupils aged 13-14 y at baseline, took part in the trial. Schools were randomised to either peer-led sex education (intervention or to continue their usual teacher-led sex education (control. Peer educators, aged 16-17 y, were trained to deliver three 1-h classroom sessions of sex education to 13- to 14-y-old pupils from the same schools. The sessions used participatory learning methods designed to improve the younger pupils' skills in sexual communication and condom use and their knowledge about pregnancy, sexually transmitted infections (STIs, contraception, and local sexual health services. Main outcome measures were abortion and live births by age 20 y, determined by anonymised linkage of girls to routine (statutory data. Assessment of these outcomes was blind to sex education allocation. The proportion of girls who had one or more abortions before age 20 y was the same in each arm (intervention, 5.0% [95% confidence interval (CI 4.0%-6.3%]; control, 5.0% [95% CI 4.0%-6.4%]. The odds ratio (OR adjusted for randomisation strata was 1.07 (95% CI 0.80-1.42, p = 0.64, intervention versus control. The proportion of girls with one or more live births by 20.5 y was 7.5% (95% CI 5.9%-9.6% in the intervention arm and 10.6% (95% CI 6.8%-16.1% in the control arm, adjusted OR 0.77 (0.51-1.15. Fewer girls in the peer-led arm self-reported a pregnancy by age 18 y (7.2% intervention versus 11.2% control, adjusted OR 0.62 [95% CI 0.42-0.91], weighted for non-response; response rate 61% intervention, 45% control

  9. A cluster randomised controlled trial of the community effectiveness of two interventions in rural Malawi to improve health care and to reduce maternal, newborn and infant mortality

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    Vergnano Stefania

    2010-09-01

    Full Text Available Abstract Background The UN Millennium Development Goals call for substantial reductions in maternal and child mortality, to be achieved through reductions in morbidity and mortality during pregnancy, delivery, postpartum and early childhood. The MaiMwana Project aims to test community-based interventions that tackle maternal and child health problems through increasing awareness and local action. Methods/Design This study uses a two-by-two factorial cluster-randomised controlled trial design to test the impact of two interventions. The impact of a community mobilisation intervention run through women's groups, on home care, health care-seeking behaviours and maternal and infant mortality, will be tested. The impact of a volunteer-led infant feeding and care support intervention, on rates of exclusive breastfeeding, uptake of HIV-prevention services and infant mortality, will also be tested. The women's group intervention will employ local female facilitators to guide women's groups through a four-phase cycle of problem identification and prioritisation, strategy identification, implementation and evaluation. Meetings will be held monthly at village level. The infant feeding intervention will select local volunteers to provide advice and support for breastfeeding, birth preparedness, newborn care and immunisation. They will visit pregnant and new mothers in their homes five times during and after pregnancy. The unit of intervention allocation will be clusters of rural villages of 2500-4000 population. 48 clusters have been defined and randomly allocated to either women's groups only, infant feeding support only, both interventions, or no intervention. Study villages are surrounded by 'buffer areas' of non-study villages to reduce contamination between intervention and control areas. Outcome indicators will be measured through a demographic surveillance system. Primary outcomes will be maternal, infant, neonatal and perinatal mortality for the

  10. A Cluster Randomised Trial Introducing Rapid Diagnostic Tests into Registered Drug Shops in Uganda: Impact on Appropriate Treatment of Malaria.

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    Anthony K Mbonye

    Full Text Available Inappropriate treatment of malaria is widely reported particularly in areas where there is poor access to health facilities and self-treatment of fevers with anti-malarial drugs bought in shops is the most common form of care-seeking. The main objective of the study was to examine the impact of introducing rapid diagnostic tests for malaria (mRDTs in registered drug shops in Uganda, with the aim to increase appropriate treatment of malaria with artemisinin-based combination therapy (ACT in patients seeking treatment for fever in drug shops.A cluster-randomized trial of introducing mRDTs in registered drug shops was implemented in 20 geographical clusters of drug shops in Mukono district, central Uganda. Ten clusters were randomly allocated to the intervention (diagnostic confirmation of malaria by mRDT followed by ACT and ten clusters to the control arm (presumptive treatment of fevers with ACT. Treatment decisions by providers were validated by microscopy on a reference blood slide collected at the time of consultation. The primary outcome was the proportion of febrile patients receiving appropriate treatment with ACT defined as: malaria patients with microscopically-confirmed presence of parasites in a peripheral blood smear receiving ACT or rectal artesunate, and patients with no malaria parasites not given ACT.A total of 15,517 eligible patients (8672 intervention and 6845 control received treatment for fever between January-December 2011. The proportion of febrile patients who received appropriate ACT treatment was 72·9% versus 33·7% in the control arm; a difference of 36·1% (95% CI: 21·3 - 50·9, p<0·001. The majority of patients with fever in the intervention arm accepted to purchase an mRDT (97·8%, of whom 58·5% tested mRDT-positive. Drug shop vendors adhered to the mRDT results, reducing over-treatment of malaria by 72·6% (95% CI: 46·7- 98·4, p<0·001 compared to drug shop vendors using presumptive diagnosis (control arm

  11. A factorial-design cluster randomised controlled trial investigating the cost-effectiveness of a nutrition supplement and an exercise programme on pneumonia incidence, walking capacity and body mass index in older people living in Santiago, Chile: the CENEX study protocol

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    Walker Damian

    2007-07-01

    Full Text Available Abstract Background Chile is currently undergoing a period of rapid demographic transition which has led to an increase in the proportion of older people in the population; the proportion aged 60 years and over, for example, increased from 8% of the population in 1980 to 12% in 2005. In an effort to promote healthy ageing and preserve function, the government of Chile has formulated a package of actions into the Programme of Complementary Feeding for the Older Population (PACAM which has been providing a nutritional supplement to older people since 1998. PACAM distributes micronutrient fortified foods to individuals aged 70 years and over registered at Primary Health Centres and enrolled in the programme. The recommended serving size (50 g/day of these supplements provides 50% of daily micronutrient requirements and 20% of daily energy requirements of older people. No information is currently available on the cost-effectiveness of the supplementation programme. Aim The aim of the CENEX cluster randomised controlled trial is to evaluate the cost-effectiveness of an ongoing nutrition supplementation programme, and a specially designed physical exercise intervention for older people of low to medium socio-economic status living in Santiago, Chile. Methods The study has been conceptualised as a public health programme effectiveness study and has been designed as a 24-month factorial cluster-randomised controlled trial conducted among 2800 individuals aged 65.0–67.9 years at baseline attending 28 health centres in Santiago. The main outcomes are incidence of pneumonia, walking capacity and change in body mass index over 24 months of intervention. Costing data (user and provider, collected at all levels, will enable the determination of the cost-effectiveness of the two interventions individually and in combination. The study is supported by the Ministry of Health in Chile, which is keen to expand and improve its national programme of nutrition for

  12. Evaluation of the impact of school gardening interventions on children's knowledge of and attitudes towards fruit and vegetables. A cluster randomised controlled trial.

    Science.gov (United States)

    Hutchinson, Jayne; Christian, Meaghan Sarah; Evans, Charlotte Elizabeth Louise; Nykjaer, Camilla; Hancock, Neil; Cade, Janet Elizabeth

    2015-08-01

    Involvement of children in gardening has the potential to increase liking of fruit and vegetables (FV) and consequently, intake, but research results are mixed. School gardening led by external specialists such as the Royal Horticultural Society (RHS) could have more impact than teacher-led gardening on children's knowledge of, and attitudes towards, FV. Data from a cluster randomised controlled trial were used to compare a RHS-led school gardening intervention with a teacher-led gardening intervention amongst 7-10 year olds in 21 London schools. A short questionnaire was developed and used to identify children's knowledge and attitudes towards FV consumption before the garden intervention and 18 months afterwards. Results from multilevel regression models, both unadjusted and adjusted for baseline responses and socio-demographic factors, were reported. Attitudes to FV intake were compared between groups. Change in FV knowledge was used to predict change in FV consumption assessed using 24-hour food diaries. In comparison with the RHS-led group (n = 373), teacher-led children (n = 404) were more likely to agree they ate lots of fruit (p gardening was associated with a greater increase in the total number of vegetables recognised (p = 0.031). No other differences in improvements in attitudes, or associations between change in FV recognition and intake were found. In relation to improvements in children's recognition and attitudes towards eating FV, this trial produced limited evidence that gardening activity packages led by external specialists (RHS-led) provide additional benefits over those led by teachers trained by the RHS. Indeed, the latter were potentially more effective. PMID:25937511

  13. Animal source foods have a positive impact on the primary school test scores of Kenyan schoolchildren in a cluster-randomised, controlled feeding intervention trial.

    Science.gov (United States)

    Hulett, Judie L; Weiss, Robert E; Bwibo, Nimrod O; Galal, Osman M; Drorbaugh, Natalie; Neumann, Charlotte G

    2014-03-14

    Micronutrient deficiencies and suboptimal energy intake are widespread in rural Kenya, with detrimental effects on child growth and development. Sporadic school feeding programmes rarely include animal source foods (ASF). In the present study, a cluster-randomised feeding trial was undertaken to determine the impact of snacks containing ASF on district-wide, end-term standardised school test scores and nutrient intake. A total of twelve primary schools were randomly assigned to one of three isoenergetic feeding groups (a local plant-based stew (githeri) with meat, githeri plus whole milk or githeri with added oil) or a control group receiving no intervention feeding. After the initial term that served as baseline, children were fed at school for five consecutive terms over two school years from 1999 to 2001. Longitudinal analysis was used controlling for average energy intake, school attendance, and baseline socio-economic status, age, sex and maternal literacy. Children in the Meat group showed significantly greater improvements in test scores than those in all the other groups, and the Milk group showed significantly greater improvements in test scores than the Plain Githeri (githeri+oil) and Control groups. Compared with the Control group, the Meat group showed significant improvements in test scores in Arithmetic, English, Kiembu, Kiswahili and Geography. The Milk group showed significant improvements compared with the Control group in test scores in English, Kiswahili, Geography and Science. Folate, Fe, available Fe, energy per body weight, vitamin B₁₂, Zn and riboflavin intake were significant contributors to the change in test scores. The greater improvements in test scores of children receiving ASF indicate improved academic performance, which can result in greater academic achievement. PMID:24168874

  14. Diagnostic accuracy of point-of-care testing for acute coronary syndromes, heart failure and thromboembolic events in primary care: a cluster-randomised controlled trial

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    Diemand Albert

    2011-03-01

    Full Text Available Abstract Background Evidence of the clinical benefit of 3-in-1 point-of-care testing (POCT for cardiac troponin T (cTnT, N-terminal pro-brain natriuretic peptide (NT-proBNP and D-dimer in cardiovascular risk stratification at primary care level for diagnosing acute coronary syndromes (ACS, heart failure (HF and thromboembolic events (TE is very limited. The aim of this study is to analyse the diagnostic accuracy of POCT in primary care. Methods Prospective multicentre controlled trial cluster-randomised to POCT-assisted diagnosis and conventional diagnosis (controls. Men and women presenting in 68 primary care practices in Zurich County (Switzerland with chest pain or symptoms of dyspnoea or TE were consecutively included after baseline consultation and working diagnosis. A follow-up visit including confirmed diagnosis was performed to determine the accuracy of the working diagnosis, and comparison of working diagnosis accuracy between the two groups. Results The 218 POCT patients and 151 conventional diagnosis controls were mostly similar in characteristics, symptoms and pre-existing diagnoses, but differed in working diagnosis frequencies. However, the follow-up visit showed no statistical intergroup difference in confirmed diagnosis frequencies. Working diagnoses overall were significantly more correct in the POCT group (75.7% vs 59.6%, p = 0.002, as were the working diagnoses of ACS/HF/TE (69.8% vs 45.2%, p = 0.002. All three biomarker tests showed good sensitivity and specificity. Conclusion POCT confers substantial benefit in primary care by correctly diagnosing significantly more patients. Trial registration DRKS: DRKS00000709

  15. A cluster randomised trial to evaluate a physical activity intervention among 3-5 year old children attending long day care services: study protocol

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    Finch Meghan

    2010-09-01

    Full Text Available Abstract Background Young children are not participating in recommended levels of physical activity and exhibit high levels of sedentary behaviour. Childcare services provide access to large numbers of young children for prolonged periods, yet there is limited experimental evidence regarding the effectiveness of physical activity interventions implemented in this setting. The aim of this study is to assess the effectiveness and acceptability of a multi-component physical activity intervention, delivered by childcare service staff, in increasing the physical activity levels of children attending long day care services. Methods/Design The study will employ a cluster randomised controlled trial design. Three hundred children aged between 3-5 years from twenty randomly selected long day care services in the Hunter Region of New South Wales, Australia will be invited to participate in the trial. Ten of the 20 long day care services will be randomly allocated to deliver the intervention with the remaining ten services allocated to a wait list control group. The physical activity intervention will consist of a number of strategies including: delivering structured fundamental movement skill activities, increasing physical activity opportunities, increasing staff role modelling, providing children with a physical activity promoting indoor and outdoor environment and limiting children's small screen recreation and sedentary behaviours. Intervention effectiveness will be measured via child physical activity levels during attendance at long day care. The study also seeks to determine the acceptability and extent of implementation of the intervention by services and their staff participating in the study. Discussion The trial will address current gaps in the research evidence base and contribute to the design and delivery of future interventions promoting physical activity for young children in long day care settings. Trial registration Australian New

  16. The effectiveness of the Liverpool care pathway in improving end of life care for dying cancer patients in hospital. A cluster randomised trial

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    Pellegrini Fabio

    2011-01-01

    Full Text Available Abstract Background Most cancer patients still die in hospital, mainly in medical wards. Many studies in different countries have shown the poor quality of end-of-life care delivery in hospitals. The Program "Liverpool Care Pathway for the dying patient" (LCP, developed in the UK to transfer the hospice model of care into hospitals and other care settings, is a complex intervention to improve the quality of end-of-life care. The results from qualitative and quantitative studies suggest that the LCP Program can improve significantly the quality of end-of-life care delivery in hospitals, but no randomised trial has been conducted till now. Methods and design This is a randomized cluster trial, stratified by regions and matched for assessment period. Pairs of eligible medical wards from different hospitals will be randomized to receive the LCP-I Program or no intervention until the end of the trial. The LCP-I Program will be implemented by a Palliative Care Unit. The assessment of the end-points will be performed for all cancer deaths occurred in the six months after the end of the LCP-I implementation in the experimental wards and, in the same period of time, in the matched control wards. The primary end-point is the overall quality of end-of-life care provided on the ward to dying cancer patients and their families, assessed using the Global Scale of the Italian version of the Toolkit "After-death Bereaved Family Member Interview". Discussion This study can be interpreted as a Phase III trial according to the Medical Research Council Framework. In this study, the effectiveness of a fully defined intervention is assessed by comparing the distribution of the endpoints in the experimental and in the control arm. Research ID RFPS-2006-6-341619 Trial registration ClinicalTrials.gov Identifier: NCT01081899

  17. A cluster randomised pragmatic trial applying Self-determination theory to type 2 diabetes care in general practice

    DEFF Research Database (Denmark)

    Juul, Lise; Maindal, Helle T; Zoffmann, Vibeke;

    2011-01-01

    BACKGROUND: Treatment recommendations for prevention of type 2 diabetes complications often require radical and life-long health behaviour changes. Observational studies based on Self-determination theory (SDT) propose substantial factors for the maintenance of behaviour changes and concomitant......, and well-being among a diabetes population, 2) the actual intervention to a level of detail that allows its replication, and 3) the connection between SDT recommendations for health care-provider behaviour and the content of the training course. METHODS/DESIGN: The study is a cluster...... intervention will be assessed on the diabetes populations with regard to well-being (PAID, SF-12), HbA1c- and cholesterol-levels, perceived autonomy support (HCCQ), type of motivation (TSRQ), and perceived competence for diabetes care (PCD) 15-21 months after the core course; the completion of the second...

  18. The Support to Rural India's Public Education System (STRIPES trial: a cluster randomised controlled trial of supplementary teaching, learning material and material support.

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    Rashmi Lakshminarayana

    Full Text Available BACKGROUND: The aim of the STRIPES trial was to assess the effectiveness of providing supplementary, remedial teaching and learning materials (and an additional 'kit' of materials for girls on a composite of language and mathematics test scores for children in classes two, three and four in public primary schools in villages in the Nagarkurnool division of Andhra Pradesh, India. METHODS: STRIPES was a cluster randomised trial in which 214 villages were allocated either to the supplementary teaching intervention (n = 107 or to serve as controls (n = 107. 54 of the intervention villages were further randomly allocated to receive additional kit for girls. The study was not blinded. Analysis was conducted on the intention to treat principle, allowing for clustering. RESULTS: Composite test scores were significantly higher in the intervention group (107 villages; 2364 children than in the control group (106 villages; 2014 children at the end of the trial (mean difference on a percentage scale 15.8; 95% CI 13.1 to 18.6; p<0.001; 0.75 Standard Deviation (SD difference. Composite test scores were not significantly different in the 54 villages (614 girls with the additional kits for girls compared to the 53 villages (636 girls without these kits at the end of the trial (mean difference on a percentage scale 0.5; 95% CI -4.34 to 5.4; p = 0.84. The cost per 0.1 SD increase in composite test score for intervention without kits is Rs. 382.97 (£4.45, $7.13, and Rs.480.59 (£5.58, $8.94 for the intervention with kits. CONCLUSIONS: A 18 month programme of supplementary remedial teaching and learning materials had a substantial impact on language and mathematics scores of primary school students in rural Andhra Pradesh, yet providing a 'kit' of materials to girls in these villages did not lead to any measured additional benefit. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN69951502.

  19. PRALIMAP: study protocol for a high school-based, factorial cluster randomised interventional trial of three overweight and obesity prevention strategies

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    Agrinier Nelly

    2010-12-01

    Full Text Available Abstract Background Given the increase in overweight and obesity prevalence in adolescents in the last decade, effective prevention strategies for these conditions in adolescents are urgently needed. The PRALIMAP (Promotion de l'ALImentation et de l'Activité Physique trial aims to evaluate the effectiveness for these conditions of 3 health promotion strategies -- educational, screening and environmental -- applied singly or in combination in high schools over a 2-year intervention period. Methods PRALIMAP is a stratified 2 × 2 × 2 factorial cluster randomised controlled trial including 24 state high schools in Lorraine, northeastern France, in 2 waves: 8 schools in 2006 (wave 1 and 16 in 2007 (wave 2. Students entering the selected high schools in the 4 academic years from 2006 to 2009 are eligible for data collection. Interventional strategies are organized over 2 academic years. The follow-up consists of 3 visits: at the entry of grade 10 (T0, grade 11 (T1 and grade 12 (T2. At T0, 5,458 (85.7% adolescents participated. The educational strategy consists of nutritional lessons, working groups and a final party. The screening strategy consists in detecting overweight/obesity and eating disorders in adolescents and proposing, if necessary, an adapted care management program of 7 group educational sessions. The environmental strategy consists in improving dietary and physical activity offerings in high schools and facilities, especially catering. The main outcomes are body size evolution over time, nutritional behaviour and knowledge, health and quality of life. An evaluation process documents how each intervention strategy is implemented in the schools and estimates the dose of the intervention, allowing for a per protocol analysis after the main intention-to-treat analysis. Discussion PRALIMAP aims at improving the prevention and management of overweight and obesity in adolescents by translating current evidence into public health practice

  20. Enhanced relapse prevention for bipolar disorder – ERP trial. A cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder

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    Peters Sarah

    2007-02-01

    Full Text Available Abstract Background Bipolar Disorder (BD is a common and severe form of mental illness characterised by repeated relapses of mania or depression. Pharmacotherapy is the main treatment currently offered, but this has only limited effectiveness. A recent Cochrane review has reported that adding psycho-social interventions that train people to recognise and manage the early warning signs of their relapses is effective in increasing time to recurrence, improving social functioning and in reducing hospitalisations. However, the review also highlights the difficulties in offering these interventions within standard mental health services due to the need for highly trained therapists and extensive input of time. There is a need to explore the potential for developing Early Warning Sign (EWS interventions in ways that will enhance dissemination. Methods and design This article describes a cluster-randomised trial to assess the feasibility of training care coordinators (CCs in community mental health teams (CMHTs to offer Enhanced Relapse Prevention (ERP to people with Bipolar Disorder. CMHTs in the North West of England are randomised to either receive training in ERP and to offer this to their clients, or to continue to offer treatment as usual (TAU. The main aims of the study are (1 to determine the acceptability of the intervention, training and outcome measures (2 to assess the feasibility of the design as measured by rates of recruitment, retention, attendance and direct feedback from participants (3 to estimate the design effect of clustering for key outcome variables (4 to estimate the effect size of the impact of the intervention on outcome. In this paper we provide a rationale for the study design, briefly outline the ERP intervention, and describe in detail the study protocol. Discussion This information will be useful to researchers attempting to carry out similar feasibility assessments of clinical effectiveness trials and in particular

  1. 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

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    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

  2. A multifaceted intervention to implement guidelines and improve admission paediatric care in Kenyan district hospitals: a cluster randomised trial.

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    Philip Ayieko

    2011-04-01

    Full Text Available BACKGROUND: In developing countries referral of severely ill children from primary care to district hospitals is common, but hospital care is often of poor quality. However, strategies to change multiple paediatric care practices in rural hospitals have rarely been evaluated. METHODS AND FINDINGS: This cluster randomized trial was conducted in eight rural Kenyan district hospitals, four of which were randomly assigned to a full intervention aimed at improving quality of clinical care (evidence-based guidelines, training, job aides, local facilitation, supervision, and face-to-face feedback; n  =  4 and the remaining four to control intervention (guidelines, didactic training, job aides, and written feedback; n  =  4. Prespecified structure, process, and outcome indicators were measured at baseline and during three and five 6-monthly surveys in control and intervention hospitals, respectively. Primary outcomes were process of care measures, assessed at 18 months postbaseline. In both groups performance improved from baseline. Completion of admission assessment tasks was higher in intervention sites at 18 months (mean  =  0.94 versus 0.65, adjusted difference 0.54 [95% confidence interval 0.05-0.29]. Uptake of guideline recommended therapeutic practices was also higher within intervention hospitals: adoption of once daily gentamicin (89.2% versus 74.4%; 17.1% [8.04%-26.1%]; loading dose quinine (91.9% versus 66.7%, 26.3% [-3.66% to 56.3%]; and adequate prescriptions of intravenous fluids for severe dehydration (67.2% versus 40.6%; 29.9% [10.9%-48.9%]. The proportion of children receiving inappropriate doses of drugs in intervention hospitals was lower (quinine dose >40 mg/kg/day; 1.0% versus 7.5%; -6.5% [-12.9% to 0.20%], and inadequate gentamicin dose (2.2% versus 9.0%; -6.8% [-11.9% to -1.6%]. CONCLUSIONS: Specific efforts are needed to improve hospital care in developing countries. A full, multifaceted intervention was associated

  3. EDUCORE project: a clinical trial, randomised by clusters, to assess the effect of a visual learning method on blood pressure control in the primary healthcare setting

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    Garrido-Elustondo Sofia

    2010-07-01

    Full Text Available Abstract Background High blood pressure (HBP is a major risk factor for cardiovascular disease (CVD. European hypertension and cardiology societies as well as expert committees on CVD prevention recommend stratifying cardiovascular risk using the SCORE method, the modification of lifestyles to prevent CVD, and achieving good control over risk factors. The EDUCORE (Education and Coronary Risk Evaluation project aims to determine whether the use of a cardiovascular risk visual learning method - the EDUCORE method - is more effective than normal clinical practice in improving the control of blood pressure within one year in patients with poorly controlled hypertension but no background of CVD; Methods/Design This work describes a protocol for a clinical trial, randomised by clusters and involving 22 primary healthcare clinics, to test the effectiveness of the EDUCORE method. The number of patients required was 736, all between 40 and 65 years of age (n = 368 in the EDUCORE and control groups, all of whom had been diagnosed with HBP at least one year ago, and all of whom had poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic ≥ 90 mmHg. All personnel taking part were explained the trial and trained in its methodology. The EDUCORE method contemplates the visualisation of low risk SCORE scores using images embodying different stages of a high risk action, plus the receipt of a pamphlet explaining how to better maintain cardiac health. The main outcome variable was the control of blood pressure; secondary outcome variables included the SCORE score, therapeutic compliance, quality of life, and total cholesterol level. All outcome variables were measured at the beginning of the experimental period and again at 6 and 12 months. Information on sex, age, educational level, physical activity, body mass index, consumption of medications, change of treatment and blood analysis results was also recorded; Discussion The

  4. Application of Balanced Scorecard in the Evaluation of a Complex Health System Intervention: 12 Months Post Intervention Findings from the BHOMA Intervention: A Cluster Randomised Trial in Zambia

    Science.gov (United States)

    Mutale, Wilbroad; Stringer, Jeffrey; Chintu, Namwinga; Chilengi, Roma; Mwanamwenge, Margaret Tembo; Kasese, Nkatya; Balabanova, Dina; Spicer, Neil; Lewis, James; Ayles, Helen

    2014-01-01

    Introduction In many low income countries, the delivery of quality health services is hampered by health system-wide barriers which are often interlinked, however empirical evidence on how to assess the level and scope of these barriers is scarce. A balanced scorecard is a tool that allows for wider analysis of domains that are deemed important in achieving the overall vision of the health system. We present the quantitative results of the 12 months follow-up study applying the balanced scorecard approach in the BHOMA intervention with the aim of demonstrating the utility of the balanced scorecard in evaluating multiple building blocks in a trial setting. Methods The BHOMA is a cluster randomised trial that aims to strengthen the health system in three rural districts in Zambia. The intervention aims to improve clinical care quality by implementing practical tools that establish clear clinical care standards through intensive clinic implementations. This paper reports the findings of the follow-up health facility survey that was conducted after 12 months of intervention implementation. Comparisons were made between those facilities in the intervention and control sites. STATA version 12 was used for analysis. Results The study found significant mean differences between intervention(I) and control (C) sites in the following domains: Training domain (Mean I:C; 87.5.vs 61.1, mean difference 23.3, p = 0.031), adult clinical observation domain (mean I:C; 73.3 vs.58.0, mean difference 10.9, p = 0.02 ) and health information domain (mean I:C; 63.6 vs.56.1, mean difference 6.8, p = 0.01. There was no gender differences in adult service satisfaction. Governance and motivation scores did not differ between control and intervention sites. Conclusion This study demonstrates the utility of the balanced scorecard in assessing multiple elements of the health system. Using system wide approaches and triangulating data collection methods seems to be key to successful

  5. Trial protocol and preliminary results for a cluster randomised trial of behavioural support versus brief advice for smoking cessation in adolescents

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    Stanton Alan

    2010-12-01

    Full Text Available Abstract Background Many young people report they want to stop smoking and have tried to do so, but most of their quit attempts fail. For adult smokers, there is strong evidence that group behavioural support enhances quit rates. However, it is uncertain whether group behavioural support enhances abstinence in young smokers trying to quit. Findings A cluster randomised trial for young people trying to stop smoking to compare the efficacy of a school-based 9 week intensive group behavioural support course versus a school-based 7 week brief advice only course. Participants were assessed for evidence of tobacco addiction and nicotine replacement therapy (NRT was used if it was deemed appropriate by the therapist. Both types of course aimed to recruit approximately one hundred participants from approximately ten schools. The primary outcome was successful quitting at 4 weeks after quit day judged according to the Russell standard. Had the trial been completed, abstinence at 6 months after quit day and the relationships between successful quit attempts and 1 psychological assessments of dependence prior to quitting 2 salivary cotinine concentration prior to quitting and 3 sociodemographic characteristics would also have been assessed. The proportion of participants who stopped smoking in each arm of the trial were compared using Chi square tests. The trial was stopped shortly after it had started because funding to support the therapists running the stop smoking group behavioural support programme was withdrawn. Only three stop smoking courses were completed (two group support courses and one brief advice pharmacotherapy course. Seventeen participants in total entered the trial. At the end of the courses, one participant (10% attending the group support programme had stopped smoking and no participant attending the brief advice programme had stopped smoking. Discussion The trial was stopped so we were unable to determine whether group support helped

  6. The ACCOMPLISH study. A cluster randomised trial on the cost-effectiveness of a multicomponent intervention to improve hand hygiene compliance and reduce healthcare associated infections

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    Steyerberg Ewout W

    2011-09-01

    Full Text Available Abstract Background Public health authorities have recognized lack of hand hygiene in hospitals as one of the important causes of preventable mortality and morbidity at population level. The implementation strategy ACCOMPLISH (Actively Creating COMPLIance Saving Health targets both individual and environmental determinants of hand hygiene. This study aims to evaluate the cost-effectiveness of a multicomponent implementation strategy aimed at the reduction of healthcare associated infections in Dutch hospital care, by promotion of hand hygiene. Methods/design The ACCOMPLISH package will be evaluated in a two-arm cluster randomised trial in 16 hospitals in the Netherlands, in one intensive care unit and one surgical ward per hospital. Intervention A multicomponent package, including e-learning, team training, introduction of electronic alcohol based hand rub dispensers and performance feedback. Variables The primary outcome measure will be the observed hand hygiene compliance rate, measured at baseline and after 6, 12 and 18 months; as a secondary outcome measure the prevalence of healthcare associated infections will be measured at the same time points. Process indicators of the intervention will be collected pre and post intervention. An ex-post economic evaluation of the ACCOMPLISH package from a healthcare perspective will be performed. Statistical analysis Multilevel analysis, using mixed linear modelling techniques will be conducted to assess the effect of the intervention strategy on the overall compliance rate among healthcare workers and on prevalence of healthcare associated infections. Questionnaires on process indicators will be analysed with multivariable linear regression, and will include both behavioural determinants and determinants of innovation. Cost-effectiveness will be assessed by calculating the incremental cost-effectiveness ratio, defined here as the costs for the intervention divided by the difference in prevalence of

  7. Promoting positive attitudes to breastfeeding: the development and evaluation of a theory-based intervention with school children involving a cluster randomised controlled trial.

    Science.gov (United States)

    Giles, Melanie; Millar, Samantha; Armour, Cherie; McClenahan, Carol; Mallett, John; Stewart-Knox, Barbara

    2015-10-01

    The objective of this study was to design, implement and evaluate an intervention based on the theory of planned behaviour (TPB) to enhance young peoples' motivations to breastfeed/support a partner to breastfeed. Six semi-structured focus groups were first conducted with 48 13-14-year-olds from two schools in Northern Ireland. The salient beliefs elicited were subsequently used to design a TPB-based questionnaire that was then administered to 2021 13-14-year-old pupils (852 males; 1169 females) from 36 post-primary schools to identify the most important determinants of breastfeeding. The results were used to inform the design and implementation of an intervention package that was subsequently evaluated using a cluster randomised controlled trial involving 44 randomly selected schools across Northern Ireland. Questionnaires were administered to 18 intervention and 26 control schools at baseline and again at 1 and 6 months post-intervention to evaluate its effectiveness. Multi-level modelling was employed to analyse the data. The results revealed significant effects on women's intention to breastfeed, β = 0.208, t(1275) = 2.715, P = 0.007; attitudes, β = 0.223, t(1275) = 4.655, P < 0.001; moral attitudes, β = 0.231, t(1275) = 4.211, P < 0.001; subjective norm, β = 0.118, t(1275) = 2.521, P = 0.012; and knowledge, β = 0.109, d.f. (1275) = 7.843, P < 0.001. However, for men, the results revealed significant effects on only the construct of knowledge, β = 0.104, t(541) = 4.345, P < 0.001.The research has provided evidence to support the need for breastfeeding education in schools and has shown how a theoretical framework may be used to inform the design and evaluation of a health behaviour intervention. PMID:24028173

  8. The study protocol of a cluster-randomised controlled trial of family-mediated personalised activities for nursing home residents with dementia

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    van der Ploeg Eva S

    2012-01-01

    Full Text Available Abstract Background Following admission to a nursing home, the feelings of depression and burden that family carers may experience do not necessarily diminish. Additionally, they may experience feelings of guilt and grief for the loss of a previously close relationship. At the same time, individuals with dementia may develop symptoms of depression and agitation (BPSD that may be related to changes in family relationships, social interaction and stimulation. Until now, interventions to alleviate carer stress and BPSD have treated carers and relatives separately rather than focusing on maintaining or enhancing their relationships. One-to-one structured activities have been shown to reduce BPSD and also improve the caring experience, but barriers such as a lack of resources impede the implementation of activities in aged care facilities. The current study will investigate the effect of individualised activities based on the Montessori methodology administered by family carers in residential care. Methods/Design We will conduct a cluster-randomised trial to train family carers in conducting personalised one-to-one activities based on the Montessori methodology with their relatives. Montessori activities derive from the principles espoused by Maria Montessori and subsequent educational theorists to promote engagement in learning, namely task breakdown, guided repetition, progression in difficulty from simple to complex, and the careful matching of demands to levels of competence. Persons with dementia living in aged care facilities and frequently visiting family carers will be included in the study. Consented, willing participants will be randomly assigned by facility to a treatment condition using the Montessori approach or a control waiting list condition. We hypothesise that family carers conducting Montessori-based activities will experience improvements in quality of visits and overall relationship with the resident as well as higher self

  9. A cluster randomised controlled trial of the clinical and cost-effectiveness of a 'whole systems' model of self-management support for the management of long- term conditions in primary care: trial protocol

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    Bower Peter

    2012-01-01

    Full Text Available Abstract Background Patients with long-term conditions are increasingly the focus of quality improvement activities in health services to reduce the impact of these conditions on quality of life and to reduce the burden on care utilisation. There is significant interest in the potential for self-management support to improve health and reduce utilisation in these patient populations, but little consensus concerning the optimal model that would best provide such support. We describe the implementation and evaluation of self-management support through an evidence-based 'whole systems' model involving patient support, training for primary care teams, and service re-organisation, all integrated into routine delivery within primary care. Methods The evaluation involves a large-scale, multi-site study of the implementation, effectiveness, and cost-effectiveness of this model of self-management support using a cluster randomised controlled trial in patients with three long-term conditions of diabetes, chronic obstructive pulmonary disease (COPD, and irritable bowel syndrome (IBS. The outcome measures include healthcare utilisation and quality of life. We describe the methods of the cluster randomised trial. Discussion If the 'whole systems' model proves effective and cost-effective, it will provide decision-makers with a model for the delivery of self-management support for populations with long-term conditions that can be implemented widely to maximise 'reach' across the wider patient population. Trial registration number ISRCTN: ISRCTN90940049

  10. IoT Big-Data Centred Knowledge Granule Analytic and Cluster Framework for BI Applications: A Case Base Analysis

    OpenAIRE

    Hsien-Tsung Chang; Nilamadhab Mishra; Chung-Chih Lin

    2015-01-01

    The current rapid growth of Internet of Things (IoT) in various commercial and non-commercial sectors has led to the deposition of large-scale IoT data, of which the time-critical analytic and clustering of knowledge granules represent highly thought-provoking application possibilities. The objective of the present work is to inspect the structural analysis and clustering of complex knowledge granules in an IoT big-data environment. In this work, we propose a knowledge granule analytic and cl...

  11. Social Stories in mainstream schools for children with autism spectrum disorder: a feasibility randomised controlled trial

    Science.gov (United States)

    Marshall, David; Wright, Barry; Allgar, Victoria; Adamson, Joy; Williams, Christine; Ainsworth, Hannah; Cook, Liz; Varley, Danielle; Hackney, Lisa; Dempster, Paul; Ali, Shehzad; Trepel, Dominic; Collingridge Moore, Danielle; Littlewood, Elizabeth; McMillan, Dean

    2016-01-01

    Objectives To assess the feasibility of recruitment, retention, outcome measures and intervention training/delivery among teachers, parents and children. To calculate a sample size estimation for full trial. Design A single-centre, unblinded, cluster feasibility randomised controlled trial examining Social Stories delivered within a school environment compared with an attentional control. Setting 37 primary schools in York, UK. Participants 50 participants were recruited and a cluster randomisation approach by school was examined. Participants were randomised into the treatment group (n=23) or a waiting list control group (n=27). Outcome measures Acceptability and feasibility of the trial, intervention and of measurements required to assess outcomes in a definitive trial. Results An assessment of the questionnaire completion rates indicated teachers would be most appropriate to complete the primary outcome measure. 2 outcome measures: the Social Responsiveness Scale (SRS)-2 and a goal-based measure showed both the highest levels of completion rates (above 80%) at the primary follow-up point (6 weeks postintervention) and captured relevant social and behaviour outcomes. Power calculations were based on these 2 outcome measures leading to a total proposed sample size of 180 participant groups. Conclusions Results suggest that a future trial would be feasible to conduct and could inform the policy and practice of using Social Stories in mainstream schools. Trial registration number ISRCTN96286707; Results. PMID:27515756

  12. IoT Big-Data Centred Knowledge Granule Analytic and Cluster Framework for BI Applications: A Case Base Analysis.

    Science.gov (United States)

    Chang, Hsien-Tsung; Mishra, Nilamadhab; Lin, Chung-Chih

    2015-01-01

    The current rapid growth of Internet of Things (IoT) in various commercial and non-commercial sectors has led to the deposition of large-scale IoT data, of which the time-critical analytic and clustering of knowledge granules represent highly thought-provoking application possibilities. The objective of the present work is to inspect the structural analysis and clustering of complex knowledge granules in an IoT big-data environment. In this work, we propose a knowledge granule analytic and clustering (KGAC) framework that explores and assembles knowledge granules from IoT big-data arrays for a business intelligence (BI) application. Our work implements neuro-fuzzy analytic architecture rather than a standard fuzzified approach to discover the complex knowledge granules. Furthermore, we implement an enhanced knowledge granule clustering (e-KGC) mechanism that is more elastic than previous techniques when assembling the tactical and explicit complex knowledge granules from IoT big-data arrays. The analysis and discussion presented here show that the proposed framework and mechanism can be implemented to extract knowledge granules from an IoT big-data array in such a way as to present knowledge of strategic value to executives and enable knowledge users to perform further BI actions. PMID:26600156

  13. IoT Big-Data Centred Knowledge Granule Analytic and Cluster Framework for BI Applications: A Case Base Analysis.

    Science.gov (United States)

    Chang, Hsien-Tsung; Mishra, Nilamadhab; Lin, Chung-Chih

    2015-01-01

    The current rapid growth of Internet of Things (IoT) in various commercial and non-commercial sectors has led to the deposition of large-scale IoT data, of which the time-critical analytic and clustering of knowledge granules represent highly thought-provoking application possibilities. The objective of the present work is to inspect the structural analysis and clustering of complex knowledge granules in an IoT big-data environment. In this work, we propose a knowledge granule analytic and clustering (KGAC) framework that explores and assembles knowledge granules from IoT big-data arrays for a business intelligence (BI) application. Our work implements neuro-fuzzy analytic architecture rather than a standard fuzzified approach to discover the complex knowledge granules. Furthermore, we implement an enhanced knowledge granule clustering (e-KGC) mechanism that is more elastic than previous techniques when assembling the tactical and explicit complex knowledge granules from IoT big-data arrays. The analysis and discussion presented here show that the proposed framework and mechanism can be implemented to extract knowledge granules from an IoT big-data array in such a way as to present knowledge of strategic value to executives and enable knowledge users to perform further BI actions.

  14. IoT Big-Data Centred Knowledge Granule Analytic and Cluster Framework for BI Applications: A Case Base Analysis.

    Directory of Open Access Journals (Sweden)

    Hsien-Tsung Chang

    Full Text Available The current rapid growth of Internet of Things (IoT in various commercial and non-commercial sectors has led to the deposition of large-scale IoT data, of which the time-critical analytic and clustering of knowledge granules represent highly thought-provoking application possibilities. The objective of the present work is to inspect the structural analysis and clustering of complex knowledge granules in an IoT big-data environment. In this work, we propose a knowledge granule analytic and clustering (KGAC framework that explores and assembles knowledge granules from IoT big-data arrays for a business intelligence (BI application. Our work implements neuro-fuzzy analytic architecture rather than a standard fuzzified approach to discover the complex knowledge granules. Furthermore, we implement an enhanced knowledge granule clustering (e-KGC mechanism that is more elastic than previous techniques when assembling the tactical and explicit complex knowledge granules from IoT big-data arrays. The analysis and discussion presented here show that the proposed framework and mechanism can be implemented to extract knowledge granules from an IoT big-data array in such a way as to present knowledge of strategic value to executives and enable knowledge users to perform further BI actions.

  15. First-principles calculations of (Y, Ti, O) cluster formation in body centred cubic iron-chromium

    Science.gov (United States)

    Claisse, Antoine; Olsson, Pär

    2013-05-01

    In the present work, the ab initio parametrization necessary for a Monte Carlo study of the (Y, Ti, O) clusters in a FeCr matrix is done. The cohesive, binding and migration energies of all the solutes have been calculated in the dilute limit in the framework of density functional theory. The special case of the strong interaction between an Y atom and a vacancy has been considered. In the dilute limit, Cr is transparent with respect to Y, Ti, O or vacancies. On the contrary, Y binds O strongly in 2NN configuration while not in 1NN. Ti binds O in 1NN and 2NN configurations. A vacancy binds strongly with Y and O in 1NN position which is resulting in a low diffusion coefficient for Y. The peculiar case of the binding attraction between two interstitial oxygen atoms has been studied and is believed to be the main reason for the planar (2D) symmetry of the cluster nuclei. A preferential cluster shape is determined for the early nucleation stage, up to 12 atoms.

  16. Radio observations of the Galactic Centre and the Coma cluster as a probe of light dark matter self-annihilations and decay

    CERN Document Server

    Boehm, Celine; Ensslin, Torsten

    2010-01-01

    We update our earlier calculations of gamma ray and radio observational constraints on annihilations of dark matter particles lighter than 10 GeV. We predict the synchrotron spectrum as well as the morphology of the radio emission associated with light decaying and annihilating dark matter candidates in both the Coma cluster and the Galactic Centre. Our new results basically confirm our previous findings: synchrotron emission in the very inner part of the Milky Way constrains or even excludes dark matter candidates if the magnetic field is larger than 50 micro Gauss. In fact, our results suggest that annihilating candidates must have a S-wave suppressed pair annihilation cross section into electrons (or produce a small number of electrons) or, if they are decaying, they must have a life time that is much larger than t = 3 10^{25} s. Therefore, radio emission should always be considered when one proposes a ``light'' dark matter candidate.

  17. Effectiveness of a Home-Based Counselling Strategy on Neonatal Care and Survival: A Cluster-Randomised Trial in Six Districts of Rural Southern Tanzania.

    Directory of Open Access Journals (Sweden)

    Claudia Hanson

    2015-09-01

    Full Text Available We report a cluster-randomised trial of a home-based counselling strategy, designed for large-scale implementation, in a population of 1.2 million people in rural southern Tanzania. We hypothesised that the strategy would improve neonatal survival by around 15%.In 2010 we trained 824 female volunteers to make three home visits to women and their families during pregnancy and two visits to them in the first few days of the infant's life in 65 wards, selected randomly from all 132 wards in six districts in Mtwara and Lindi regions, constituting typical rural areas in Southern Tanzania. The remaining wards were comparison areas. Participants were not blinded to the intervention. The primary analysis was an intention-to-treat analysis comparing the neonatal mortality (day 0-27 per 1,000 live births in intervention and comparison wards based on a representative survey in 185,000 households in 2013 with a response rate of 90%. We included 24,381 and 23,307 live births between July 2010 and June 2013 and 7,823 and 7,555 live births in the last year in intervention and comparison wards, respectively. We also compared changes in neonatal mortality and newborn care practices in intervention and comparison wards using baseline census data from 2007 including 225,000 households and 22,243 births in five of the six intervention districts. Amongst the 7,823 women with a live birth in the year prior to survey in intervention wards, 59% and 41% received at least one volunteer visit during pregnancy and postpartum, respectively. Neonatal mortality reduced from 35.0 to 30.5 deaths per 1,000 live births between 2007 and 2013 in the five districts, respectively. There was no evidence of an impact of the intervention on neonatal survival (odds ratio [OR] 1.1, 95% confidence interval [CI] 0.9-1.2, p = 0.339. Newborn care practices reported by mothers were better in intervention than in comparison wards, including immediate breastfeeding (42% of 7,287 versus 35% of 7

  18. Can Topical Insect Repellents Reduce Malaria? A Cluster-Randomised Controlled Trial of the Insect Repellent N,N-diethyl-m-toluamide (DEET) in Lao PDR.

    OpenAIRE

    Vanessa Chen-Hussey; Ilona Carneiro; Hongkham Keomanila; Rob Gray; Sihamano Bannavong; Saysana Phanalasy; Lindsay, Steven W

    2013-01-01

    BACKGROUND Mosquito vectors of malaria in Southeast Asia readily feed outdoors making malaria control through indoor insecticides such as long-lasting insecticidal nets (LLINs) and indoor residual spraying more difficult. Topical insect repellents may be able to protect users from outdoor biting, thereby providing additional protection above the current best practice of LLINs. METHODS AND FINDINGS A double blind, household randomised, placebo-controlled trial of insect repellent to reduc...

  19. Effect of home-based counselling on newborn care practices in southern Tanzania one year after implementation: a cluster-randomised controlled trial

    OpenAIRE

    Penfold, S.; Manzi, F.; Mkumbo, E; Temu, S; Jaribu, J.; Shamba, DD; Mshinda, H; Cousens, S.; Marchant, T; Tanner, M; Schellenberg, D; Armstrong Schellenberg, J

    2014-01-01

    BACKGROUND In Sub-Saharan Africa over one million newborns die annually. We developed a sustainable and scalable home-based counselling intervention for delivery by community volunteers in rural southern Tanzania to improve newborn care practices and survival. Here we report the effect on newborn care practices one year after full implementation. METHODS All 132 wards in the 6-district study area were randomised to intervention or comparison groups. Starting in 2010, in intervention area...

  20. The 5x1 DAFNE study protocol: a cluster randomised trial comparing a standard 5 day DAFNE course delivered over 1 week against DAFNE training delivered over 1 day a week for 5 consecutive weeks

    Directory of Open Access Journals (Sweden)

    Elliott Jackie

    2012-11-01

    Full Text Available Abstract Background Structured education programmes are now established as an essential component to assist effective self-management of diabetes. In the case of Type 1 diabetes, the Dose Adjustment For Normal Eating (DAFNE programme improves both glycaemic control and quality of life. Traditionally delivered over five consecutive days, this format has been cited as a barrier to participation by some patients, such as those who work full-time. Some centres in the UK have organised structured education programmes to be delivered one day a week over several consecutive weeks. This type of format may add benefit by allowing more time in which to practice skills between sessions, but may suffer as a result of weaker peer support being generated compared to that formed over five consecutive days. Methods/design We aim to compare DAFNE delivered over five consecutive days (1 week course with DAFNE delivered one day a week over five weeks (5 week course in a randomised controlled trial. A total of 213 patients were randomised to attend either a 1 week or a 5 week course delivered in seven participating centres. Study outcomes (measured at baseline, 6 and 12 months post-course include HbA1c, weight, self-reported rates of severe hypoglycaemia, psychosocial measures of quality of life, and cost-effectiveness. Generalisability was optimised by recruiting patients from DAFNE waiting lists at each centre, and by mailing eligible patients from hospital clinic lists. The inclusion and exclusion criteria were identical to those used to recruit to a standard DAFNE course (e.g., HbA1c Discussion This trial has been designed to test the hypothesis that the benefits of delivering a structured education programme over 5 weeks are comparable to those observed after a 1 week course. The results of the trial and the qualitative sub-study will both inform the design and delivery of future DAFNE courses, and the development of structured education programmes in other

  1. Effectiveness of a structured education reminiscence-based programme for staff on the quality of life of residents with dementia in long-stay units: A study protocol for a cluster randomised trial

    LENUS (Irish Health Repository)

    O'Shea, Eamon

    2011-02-14

    Abstract Background Current projections indicate that there will be a significant increase in the number of people with dementia in Ireland, from approximately 40,000 at present to 100,000 by 2036. Psychosocial interventions, such as reminiscence, have the potential to improve the quality of life of people with dementia. However, while reminiscence is used widely in dementia care, its impact on the quality of life of people with dementia remains largely undocumented and there is a need for a robust and fair assessment of its overall effectiveness. The DementiA education programme incorporating REminiscence for Staff study will evaluate the effectiveness of a structured reminiscence-based education programme for care staff on the quality of life of residents with dementia in long-stay units. Methods\\/Design The study is a two-group, single-blind cluster randomised trial conducted in public and private long-stay residential settings in Ireland. Randomisation to control and intervention is at the level of the long-stay residential unit. Sample size calculations suggest that 18 residential units each containing 17 people with dementia are required for randomisation to control and intervention groups to achieve power of at least 80% with alpha levels of 0.05. Each resident in the intervention group is linked with a nurse and care assistant who have taken the structured reminiscence-based education programme. Participants in the control group will receive usual care. The primary outcome is quality of life of residents as measured by the Quality of Life-AD instrument. Secondary outcomes include agitation, depression and carer burden. Blinded outcome assessment is undertaken at baseline and at 18-22 weeks post-randomisation. Discussion Trials on reminiscence-based interventions for people with dementia have been scarce and the quality of the information arising from those that have been done has been undermined by methodological problems, particularly in relation to scale

  2. Improving management of patients with acute cough by C-reactive protein point of care testing and communication training (IMPAC3T: study protocol of a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Severens Johan L

    2007-03-01

    Full Text Available Abstract Background Most antibiotic prescriptions for acute cough due to lower respiratory tract infections (LRTI in primary care are not warranted. Diagnostic uncertainty and patient expectations and worries are major drivers of unnecessary antibiotic prescribing. A C-reactive protein (CRP point of care test may help GPs to better guide antibiotic treatment by ruling out pneumonia in cases of low test results. Alternatively, enhanced communication skills training to help clinicians address patients' expectations and worries could lead to a decrease in antibiotic prescribing, without compromising clinical recovery, while enhancing patient enablement. The aim of this paper is to describe the design and methods of a study to assess two interventions for improving LRTI management in general practice. Methods/Design This cluster randomised controlled, factorial trial will introduce two interventions in general practice; point of care CRP testing and enhanced communication skills training for LRTI. Twenty general practices with two participating GPs per practice will recruit 400 patients with LRTI during two winter periods. Patients will be followed up for at least 28 days. The primary outcome measure is the antibiotic prescribing rate. Secondary outcomes are clinical recovery, cost-effectiveness, use of other diagnostic tests and medical services (including reconsultation, and patient enablement. Discussion This trial is the first cluster randomised trial to evaluate the influence of point of care CRP testing in the hands of the general practitioner and enhanced communication skills, on the management of LRTI in primary care. The pragmatic nature of the study, which leaves treatment decisions up to the responsible clinicians, will enhance the applicability and generalisability of findings. The factorial design will allow conclusion to be made about the value of CRP testing on its own, communication skills training on its own, and the two combined

  3. Development and Evaluation of a Psychosocial Intervention for Children and Teenagers Experiencing Diabetes (DEPICTED: a protocol for a cluster randomised controlled trial of the effectiveness of a communication skills training programme for healthcare professionals working with young people with type 1 diabetes

    Directory of Open Access Journals (Sweden)

    Lowes Lesley

    2010-02-01

    Full Text Available Abstract Background Diabetes is the third most common chronic condition in childhood and poor glycaemic control leads to serious short-term and life-limiting long-term complications. In addition to optimal medical management, it is widely recognised that psychosocial and educational factors play a key role in improving outcomes for young people with diabetes. Recent systematic reviews of psycho-educational interventions recognise the need for new methods to be developed in consultation with key stakeholders including patients, their families and the multidisciplinary diabetes healthcare team. Methods/design Following a development phase involving key stakeholders, a psychosocial intervention for use by paediatric diabetes staff and not requiring input from trained psychologists has been developed, incorporating a communication skills training programme for health professionals and a shared agenda-setting tool. The effectiveness of the intervention will be evaluated in a cluster-randomised controlled trial (RCT. The primary outcome, to be measured in children aged 4-15 years diagnosed with type 1 diabetes for at least one year, is the effect on glycaemic control (HbA1c during the year after training of the healthcare team is completed. Secondary outcomes include quality of life for patients and carers and cost-effectiveness. Patient and carer preferences for service delivery will also be assessed. Twenty-six paediatric diabetes teams are participating in the trial, recruiting a total of 700 patients for evaluation of outcome measures. Half the participating teams will be randomised to receive the intervention at the beginning of the trial and remaining centres offered the training package at the end of the one year trial period. Discussion The primary aim of the trial is to determine whether a communication skills training intervention for specialist paediatric diabetes teams will improve clinical and psychological outcomes for young people with

  4. Effect of osteosynthesis, primary hemiarthroplasty, and non-surgical management for displaced four-part fractures of the proximal humerus in elderly: a multi-centre, randomised clinical trial

    OpenAIRE

    Johannsen Hans; Jensen Steen; Frich Lars; Olsen Bo; Brorson Stig; Sørensen Anne; Hrobjartsson Asbjørn

    2009-01-01

    Abstract Background Fractures of the proximal humerus are common injuries and account for 4–5 percent of all fractures, second only to hip and wrist fractures. The incidence is positively correlated with age and osteoporosis, and is likely to increase. Displaced four-part fractures are among the most severe injuries, accounting for 2–10 percent of proximal humeral fractures. The optimal intervention is disputed. Two previous randomised trials were very small and involved a noticeable risk of ...

  5. Early intervention for depression and anxiety in 16-18-year-olds: Protocol for a feasibility cluster randomised controlled trial of open-access psychological workshops in schools (DISCOVER).

    Science.gov (United States)

    Michelson, Daniel; Sclare, Irene; Stahl, Daniel; Morant, Nicola; Bonin, Eva-Maria; Brown, June S L

    2016-05-01

    Adolescence is a vulnerable period for the development of mental health problems. The DISCOVER intervention aims to provide accessible, acceptable and cost-effective psychological support for stressed adolescents in inner-city secondary schools. The intervention uses age-appropriate cognitive-behavioural therapy (CBT) methods and materials, delivered in an interactive 1-day workshop with additional telephone support. An open-access entry route allows students to self-refer. This protocol describes a feasibility cluster randomised controlled trial (RCT) comparing DISCOVER with a waitlist control condition. The study will run across 10 clusters (secondary schools) in the inner London Boroughs of Southwark and Lambeth. Participants are students aged over 16years who are seeking help with anxiety and/or depressive symptoms. Key feasibility parameters relate to the proportion of students willing to participate in the research following publicity events; the proportion of students who complete the intervention; and response rates for outcome measures. Outcome variance estimates and intra-cluster correlations will be obtained for future power calculations. Qualitative methods will be used to explore the acceptability of the intervention and research procedures for students and school staff. The feasibility of an economic evaluation will also be examined. The results will (i) determine the appropriateness of proceeding to a definitive full-scale trial; and (ii) inform the development of an optimised version of the DISCOVER intervention that can be tested within feasible parameters. PMID:26883283

  6. Timing of birth for women with a twin pregnancy at term: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Haslam Ross R

    2010-10-01

    Full Text Available Abstract Background There is a well recognized risk of complications for both women and infants of a twin pregnancy, increasing beyond 37 weeks gestation. Preterm birth prior to 37 weeks gestation is a recognized complication of a twin pregnancy, however, up to 50% of twins will be born after this time. The aims of this randomised trial are to assess whether elective birth at 37 weeks gestation compared with standard care in women with a twin pregnancy affects the risk of perinatal death, and serious infant complications. Methods/Design Design: Multicentred randomised trial. Inclusion Criteria: women with a twin pregnancy at 366 weeks or more without contraindication to continuation of pregnancy. Trial Entry & Randomisation: Following written informed consent, eligible women will be randomised from 36+6 weeks gestation. The randomisation schedule uses balanced variable blocks, with stratification for centre of birth and planned mode of birth. Women will be randomised to either elective birth or standard care. Treatment Schedules: Women allocated to the elective birth group will be planned for elective birth from 37 weeks gestation. Where the plan is for vaginal birth, this will involve induction of labour. Where the plan is for caesarean birth, this will involve elective caesarean section. For women allocated to standard care, birth will be planned for 38 weeks gestation or later. Where the plan is for vaginal birth, this will involve either awaiting the spontaneous onset of labour, or induction of labour if required. Where the plan is for caesarean birth, this will involve elective caesarean section (after 38 and as close to 39 weeks as possible. Primary Study Outcome: A composite of perinatal mortality or serious neonatal morbidity. Sample Size: 460 women with a twin pregnancy to show a reduction in the composite outcome from 16.3% to 6.7% with adjustment for the clustering of twin infants within mothers (p = 0.05, 80% power. Discussion This

  7. Clustering

    Directory of Open Access Journals (Sweden)

    Jinfei Liu

    2013-04-01

    Full Text Available DBSCAN is a well-known density-based clustering algorithm which offers advantages for finding clusters of arbitrary shapes compared to partitioning and hierarchical clustering methods. However, there are few papers studying the DBSCAN algorithm under the privacy preserving distributed data mining model, in which the data is distributed between two or more parties, and the parties cooperate to obtain the clustering results without revealing the data at the individual parties. In this paper, we address the problem of two-party privacy preserving DBSCAN clustering. We first propose two protocols for privacy preserving DBSCAN clustering over horizontally and vertically partitioned data respectively and then extend them to arbitrarily partitioned data. We also provide performance analysis and privacy proof of our solution..

  8. 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

  9. Impact of a nurse-led intervention to improve screening for cardiovascular risk factors in people with severe mental illnesses. Phase-two cluster randomised feasibility trial of community mental health teams

    Directory of Open Access Journals (Sweden)

    Nazareth Irwin

    2010-03-01

    CVD risk factor. The feasibility of the trial was confirmed in terms of CMHT recruitment and the intervention, but the response rate for outcome collection was disappointing; possibly a result of the cluster design. The trial was not large or long enough to detect changes in risk factors. Trial Registration International Standard Randomised Controlled Trial Registration Number (ISRCTRN 58625025.

  10. A cluster randomised controlled trial evaluating the effectiveness of a structured pulmonary rehabilitation education programme for improving the health status of people with chronic obstructive pulmonary disease (COPD: The PRINCE Study protocol

    Directory of Open Access Journals (Sweden)

    Nichulain Martina

    2011-01-01

    Full Text Available Abstract Background A key strategy in improving care for people with chronic obstructive pulmonary disease (COPD is the provision of pulmonary rehabilitation programmes. Pulmonary rehabilitation programmes have been successful in improving patients' sense of dyspnoea and Health Related Quality of Life. However, the effectiveness of structured education pulmonary rehabilitation programmes delivered at the level of the general practice on the health status of people with COPD remains uncertain and there is a need for a robust and fair assessment of this. The PRINCE study will evaluate the effectiveness of a Structured Education Pulmonary Rehabilitation Programme (SEPRP, delivered at the level of the general practice, on the health status of people with COPD. Methods/Design The PRINCE Trial is a two-armed, single blind cluster randomised trial conducted in the primary care setting in Ireland. Randomisation to control and intervention is at the level of the General Practice. Participants in the intervention arm will receive a SEPRP and those allocated to the control arm will receive usual care. Delivery of the SEPRP will be by a practice nurse and physiotherapist in the General Practice (GP site. The primary outcome measure of the study will be health status as measured by the Chronic Respiratory Questionnaire (CRQ. Blinded outcome assessment will be undertaken at baseline and at twelve-fourteen weeks after completion of the programme. A comparison of outcomes between the intervention and control sites will be made to examine if differences exist and, if so, to what extent between control and experimental groups. Sample size calculations estimate that 32 practices with a minimum of 10 participants per practice are required, in total, to be randomised to control and intervention arms for power of at least 80% with alpha levels of 0.05, to determine a clinically significant change of 0.5 units in the CRQ. A cost effectiveness analysis will also be

  11. Supporting teachers and children in schools: the effectiveness and cost-effectiveness of the incredible years teacher classroom management programme in primary school children: a cluster randomised controlled trial, with parallel economic and process evaluations

    Directory of Open Access Journals (Sweden)

    Ford Tamsin

    2012-08-01

    Full Text Available Abstract Background Childhood antisocial behaviour has high immediate and long-term costs for society and the individual, particularly in relation to mental health and behaviours that jeopardise health. Managing challenging behaviour is a commonly reported source of stress and burn out among teachers, ultimately resulting in a substantial number leaving the profession. Interventions to improve parenting do not transfer easily to classroom-based problems and the most vulnerable parents may not be easily able to access them. Honing teachers’ skills in proactive behaviour management and the promotion of socio-emotional regulation, therefore, has the potential to improve both child and teacher mental health and well-being and the advantage that it might potentially benefit all the children subsequently taught by any teacher that accesses the training. Methods/Design Cluster randomised controlled trial (RCT of the Incredible Years teacher classroom management (TCM course with combined economic and process evaluations. One teacher of children aged 4–9 years, from 80 schools in the South West Peninsula will be randomised to attend the TCM (intervention arm or to “teach as normal” (control arm. The primary outcome measure will be the total difficulties score from the Strengths and Difficulties Questionnaire (SDQ completed by the current class teachers prior to randomisation, and at 9, 18 and 30 months follow-up, supplemented by parent SDQs. Secondary measures include academic attainment (teacher report supplemented by direct measurement in a sub-sample, children’s enjoyment of school, and teacher reports of their professional self-efficacy, and levels of burn out and stress, supplemented by structured observations of teachers classroom management skills in a subsample. Cost data for the economic evaluation will be based on parental reports of services accessed. Cost-effectiveness, using the SDQ as the measure of effect, will be examined

  12. A cluster randomised controlled trial of a pharmacist-led collaborative intervention to improve statin prescribing and attainment of cholesterol targets in primary care.

    Directory of Open Access Journals (Sweden)

    Richard Lowrie

    Full Text Available Small trials with short term follow up suggest pharmacists' interventions targeted at healthcare professionals can improve prescribing. In comparison with clinical guidance, contemporary statin prescribing is sub-optimal and achievement of cholesterol targets falls short of accepted standards, for patients with atherosclerotic vascular disease who are at highest absolute risk and who stand to obtain greatest benefit. We hypothesised that a pharmacist-led complex intervention delivered to doctors and nurses in primary care, would improve statin prescribing and achievement of cholesterol targets for incident and prevalent patients with vascular disease, beyond one year.We allocated general practices to a 12-month Statin Outreach Support (SOS intervention or usual care. SOS was delivered by one of 11 pharmacists who had received additional training. SOS comprised academic detailing and practical support to identify patients with vascular disease who were not prescribed a statin at optimal dose or did not have cholesterol at target, followed by individualised recommendations for changes to management. The primary outcome was the proportion of patients achieving cholesterol targets. Secondary outcomes were: the proportion of patients prescribed simvastatin 40 mg with target cholesterol achieved; cholesterol levels; prescribing of simvastatin 40 mg; prescribing of any statin and the proportion of patients with cholesterol tested. Outcomes were assessed after an average of 1.7 years (range 1.4-2.2 years, and practice level simvastatin 40 mg prescribing was assessed after 10 years.We randomised 31 practices (72 General Practitioners (GPs, 40 nurses. Prior to randomisation a subset of eligible patients were identified to characterise practices; 40% had cholesterol levels below the target threshold. Improvements in data collection procedures allowed identification of all eligible patients (n = 7586 at follow up. Patients in practices allocated to SOS were

  13. Can topical insect repellents reduce malaria? A cluster-randomised controlled trial of the insect repellent N,N-diethyl-m-toluamide (DEET in Lao PDR.

    Directory of Open Access Journals (Sweden)

    Vanessa Chen-Hussey

    Full Text Available BACKGROUND: Mosquito vectors of malaria in Southeast Asia readily feed outdoors making malaria control through indoor insecticides such as long-lasting insecticidal nets (LLINs and indoor residual spraying more difficult. Topical insect repellents may be able to protect users from outdoor biting, thereby providing additional protection above the current best practice of LLINs. METHODS AND FINDINGS: A double blind, household randomised, placebo-controlled trial of insect repellent to reduce malaria was carried out in southern Lao PDR to determine whether the use of repellent and long-lasting insecticidal nets (LLINs could reduce malaria more than LLINs alone. A total of 1,597 households, including 7,979 participants, were recruited in June 2009 and April 2010. Equal group allocation, stratified by village, was used to randomise 795 households to a 15% DEET lotion and the remainder were given a placebo lotion. Participants, field staff and data analysts were blinded to the group assignment until data analysis had been completed. All households received new LLINs. Participants were asked to apply their lotion to exposed skin every evening and sleep under the LLINs each night. Plasmodium falciparum and P. vivax cases were actively identified by monthly rapid diagnostic tests. Intention to treat analysis found no effect from the use of repellent on malaria incidence (hazard ratio: 1.00, 95% CI: 0.99-1.01, p = 0.868. A higher socio-economic score was found to significantly decrease malaria risk (hazard ratio: 0.72, 95% CI: 0.58-0.90, p = 0.004. Women were also found to have a reduced risk of infection (hazard ratio: 0.59, 95% CI: 0.37-0.92, p = 0.020. According to protocol analysis which excluded participants using the lotions less than 90% of the time found similar results with no effect from the use of repellent. CONCLUSIONS: This randomised controlled trial suggests that topical repellents are not a suitable intervention in addition to

  14. A cluster randomised trial of a telephone-based intervention for parents to increase fruit and vegetable consumption in their 3- to 5-year-old children: study protocol

    Directory of Open Access Journals (Sweden)

    Fletcher Amanda

    2010-04-01

    Full Text Available Abstract Background Inadequate fruit and vegetable consumption in childhood increases the risk of developing chronic disease. Despite this, a substantial proportion of children in developed nations, including Australia, do not consume sufficient quantities of fruits and vegetables. Parents are influential in the development of dietary habits of young children but often lack the necessary knowledge and skills to promote healthy eating in their children. The aim of this study is to assess the efficacy of a telephone-based intervention for parents to increase the fruit and vegetable consumption of their 3- to 5-year-old children. Methods/Design The study, conducted in the Hunter region of New South Wales, Australia, employs a cluster randomised controlled trial design. Two hundred parents from 15 randomly selected preschools will be randomised to receive the intervention, which consists of print resources and four weekly 30-minute telephone support calls delivered by trained telephone interviewers. The calls will assist parents to increase the availability and accessibility of fruit and vegetables in the home, create supportive family eating routines and role-model fruit and vegetable consumption. A further two hundred parents will be randomly allocated to the control group and will receive printed nutrition information only. The primary outcome of the trial will be the change in the child's consumption of fruit and vegetables as measured by the fruit and vegetable subscale of the Children's Dietary Questionnaire. Pre-intervention and post-intervention parent surveys will be administered over the telephone. Baseline surveys will occur one to two weeks prior to intervention delivery, with follow-up data collection calls occurring two, six, 12 and 18 months following baseline data collection. Discussion If effective, this telephone-based intervention may represent a promising public health strategy to increase fruit and vegetable consumption in

  15. Evidence-based interventions in dementia: A pragmatic cluster-randomised trial of an educational intervention to promote earlier recognition and response to dementia in primary care (EVIDEM-ED

    Directory of Open Access Journals (Sweden)

    Koch Tamar

    2010-02-01

    Full Text Available Abstract Background The National Dementia Strategy seeks to enhance general practitioners' diagnostic and management skills in dementia. Early diagnosis in dementia within primary care is important as this allows those with dementia and their family care networks to engage with support services and plan for the future. There is, however, evidence that dementia remains under-detected and sub-optimally managed in general practice. An earlier unblinded, cluster randomised controlled study tested the effectiveness of educational interventions in improving detection rates and management of dementia in primary care. In this original trial, a computer decision support system and practice-based educational workshops were effective in improving rates of detecting dementia although not in changing clinical management. The challenge therefore is to find methods of changing clinical management. Our aim in this new trial is to test a customised educational intervention developed for general practice, promoting both earlier diagnosis and concordance with management guidelines. Design/Method The customised educational intervention combines practice-based workshops and electronic support material. Its effectiveness will be tested in an unblinded cluster randomised controlled trial with a pre-post intervention design, with two arms; normal care versus the educational intervention. Twenty primary care practices have been recruited with the aim of gaining 200 patient participants. We will examine whether the intervention is effective, pragmatic and feasible within the primary care setting. Our primary outcome measure is an increase in the proportion of patients with dementia who receive at least two dementia-specific management reviews per year. We will also examine important secondary outcomes such as practice concordance with management guidelines and benefits to patients and carers in terms of quality of life and carer strain. Discussion The EVIDEM-ED trial

  16. Evaluation of an evidence-based guidance on the reduction of physical restraints in nursing homes: a cluster-randomised controlled trial [ISRCTN34974819

    OpenAIRE

    Haastert Burkhard; Mühlhauser Ingrid; Gerlach Anja; Köpke Sascha; Haut Antonie; Meyer Gabriele

    2009-01-01

    Abstract Background Physical restraints are regularly applied in German nursing homes. Their frequency varies substantially between centres. Beneficial effects of physical restraints have not been proven, however, observational studies and case reports suggest various adverse effects. We developed an evidence-based guidance on this topic. The present study evaluates the clinical efficacy and safety of an intervention programme based on this guidance aimed to reduce physical restraints and min...

  17. London Education and Inclusion Project (LEIP): Exploring Negative and Null Effects of a Cluster-Randomised School-Intervention to Reduce School Exclusion—Findings from Protocol-Based Subgroup Analyses

    Science.gov (United States)

    Obsuth, Ingrid; Cope, Aiden; Sutherland, Alex; Pilbeam, Liv; Murray, Aja Louise; Eisner, Manuel

    2016-01-01

    This paper presents subgroup analyses from the London Education and Inclusion Project (LEIP). LEIP was a cluster-randomised controlled trial of an intervention called Engage in Education-London (EiE-L) which aimed to reduce school exclusions in those at greatest risk of exclusion. Pupils in the control schools attended an hour-long employability seminar. Minimisation was used to randomly assign schools to treatment and control following baseline data collection. The study involved 36 schools (17 in treatment—373 pupils; 19 in control—369 pupils) with >28% free school meal eligibility across London and utilised on pupil self-reports, teacher reports as well as official records to assess the effectiveness of EiE-L. Due to multiple data sources, sample sizes varied according to analysis. Analyses of pre-specified subgroups revealed null and negative effects on school exclusion following the intervention. Our findings suggest that the design and implementation of EiE-L may have contributed to the negative outcomes for pupils in the treatment schools when compared to those in the control schools. These findings call into question the effectiveness of bolt-on short-term interventions with pupils, particularly those at the highest risk of school exclusion and when they are faced with multiple problems. This is especially pertinent given the possibility of negative outcomes. Trial Registration: Controlled Trials: ISRCTN23244695 PMID:27045953

  18. A school-based intervention incorporating smartphone technology to improve health-related fitness among adolescents: rationale and study protocol for the NEAT and ATLAS 2.0 cluster randomised controlled trial and dissemination study

    Science.gov (United States)

    Lubans, David R; Smith, Jordan J; Peralta, Louisa R; Plotnikoff, Ronald C; Okely, Anthony D; Salmon, Jo; Eather, Narelle; Dewar, Deborah L; Kennedy, Sarah; Lonsdale, Chris; Hilland, Toni A; Estabrooks, Paul; Finn, Tara L; Pollock, Emma; Morgan, Philip J

    2016-01-01

    Introduction Physical inactivity has been described as a global pandemic. Interventions aimed at developing skills in lifelong physical activities may provide the foundation for an active lifestyle into adulthood. In general, school-based physical activity interventions targeting adolescents have produced modest results and few have been designed to be ‘scaled-up’ and disseminated. This study aims to: (1) assess the effectiveness of two physical activity promotion programmes (ie, NEAT and ATLAS) that have been modified for scalability; and (2) evaluate the dissemination of these programmes throughout government funded secondary schools. Methods and analysis The study will be conducted in two phases. In the first phase (cluster randomised controlled trial), 16 schools will be randomly allocated to the intervention or a usual care control condition. In the second phase, the Reach, Effectiveness, Adoption, Implementation and Maintenance (Re-AIM) framework will be used to guide the design and evaluation of programme dissemination throughout New South Wales (NSW), Australia. In both phases, teachers will be trained to deliver the NEAT and ATLAS programmes, which will include: (1) interactive student seminars; (2) structured physical activity programmes; (3) lunch-time fitness sessions; and (4) web-based smartphone apps. In the cluster RCT, study outcomes will be assessed at baseline, 6 months (primary end point) and 12-months. Muscular fitness will be the primary outcome and secondary outcomes will include: objectively measured body composition, cardiorespiratory fitness, flexibility, resistance training skill competency, physical activity, self-reported recreational screen-time, sleep, sugar-sweetened beverage and junk food snack consumption, self-esteem and well-being. Ethics and dissemination This study has received approval from the University of Newcastle (H-2014-0312) and the NSW Department of Education (SERAP: 2012121) human research ethics committees. This

  19. Bristol girls dance project (BGDP): protocol for a cluster randomised controlled trial of an after-school dance programme to increase physical activity among 11–12 year old girls

    Science.gov (United States)

    2013-01-01

    Background Many children do not meet current UK physical activity (PA) guidelines. Girls are less active than boys throughout childhood, and the age-related decline in PA, particularly from early adolescence, is steeper for girls than for boys. Dance is the favourite form of PA among UK secondary school aged girls. Delivering dance sessions after school could make a significant contribution to girls’ PA. Therefore, after-school dance sessions may be an appropriate and cost-effective activity through which adolescent girls’ PA levels can be increased. Design Two-arm cluster randomised control trial and economic evaluation conducted in 18 secondary schools across the greater Bristol area. All Year 7 girls in participating schools will receive a 'taster’ dance session and subsequently be invited to participate in the project. There is space for up to 33 girls to participate in each school. Schools will be randomly assigned in equal numbers to intervention or control arms after baseline data has been collected. The nine intervention schools will receive a 20 week after-school dance-based intervention, consisting of 40 × 75 minute sessions, delivered by external dance instructors. Control schools will not receive the dance intervention. All measures will be assessed at baseline (time 0), at the end of the intervention period (time 1) and six months after the intervention has ended (time 2). Our primary interest is to determine the effectiveness and cost-effectiveness of the intervention to affect the objectively-assessed (accelerometer) mean weekday minutes of moderate-to-vigorous PA (MVPA) accumulated by Year 7 girls one year after the baseline measurement (time 2). Discussion This paper describes the protocol for the Bristol Girls Dance Project cluster randomized controlled trial and economic evaluation, which is attempting to increase MVPA among Year 7 girls in UK secondary schools. Trial registration ISRCTN52882523. PMID:24152257

  20. HIV prevention in Mexican schools: prospective randomised evaluation of intervention

    OpenAIRE

    Walker, D.; Gutierrez, JP; TORRES, P.; Bertozzi, SM

    2006-01-01

    OBJECTIVE: To assess effects on condom use and other sexual behaviour of an HIV prevention programme at school that promotes the use of condoms with and without emergency contraception. DESIGN: Cluster randomised controlled trial. SETTING: 40 public high schools in the state of Morelos, Mexico. PARTICIPANTS: 10 954 first year high school students. INTERVENTION: Schools were randomised to one of three arms: an HIV prevention course that promoted condom use, the same course with emergency contr...

  1. Protocol for the PINCER trial: a cluster randomised trial comparing the effectiveness of a pharmacist-led IT-based intervention with simple feedback in reducing rates of clinically important errors in medicines management in general practices

    Directory of Open Access Journals (Sweden)

    Murray Scott A

    2009-05-01

    Full Text Available Abstract Background Medication errors are an important cause of morbidity and mortality in primary care. The aims of this study are to determine the effectiveness, cost effectiveness and acceptability of a pharmacist-led information-technology-based complex intervention compared with simple feedback in reducing proportions of patients at risk from potentially hazardous prescribing and medicines management in general (family practice. Methods Research subject group: "At-risk" patients registered with computerised general practices in two geographical regions in England. Design: Parallel group pragmatic cluster randomised trial. Interventions: Practices will be randomised to either: (i Computer-generated feedback; or (ii Pharmacist-led intervention comprising of computer-generated feedback, educational outreach and dedicated support. Primary outcome measures: The proportion of patients in each practice at six and 12 months post intervention: - with a computer-recorded history of peptic ulcer being prescribed non-selective non-steroidal anti-inflammatory drugs - with a computer-recorded diagnosis of asthma being prescribed beta-blockers - aged 75 years and older receiving long-term prescriptions for angiotensin converting enzyme inhibitors or loop diuretics without a recorded assessment of renal function and electrolytes in the preceding 15 months. Secondary outcome measures; These relate to a number of other examples of potentially hazardous prescribing and medicines management. Economic analysis: An economic evaluation will be done of the cost per error avoided, from the perspective of the UK National Health Service (NHS, comparing the pharmacist-led intervention with simple feedback. Qualitative analysis: A qualitative study will be conducted to explore the views and experiences of health care professionals and NHS managers concerning the interventions, and investigate possible reasons why the interventions prove effective, or conversely prove

  2. Implementing evidence-based recommended practices for the management of patients with mild traumatic brain injuries in Australian emergency care departments: study protocol for a cluster randomised controlled trial

    Science.gov (United States)

    2014-01-01

    Background Mild head injuries commonly present to emergency departments. The challenges facing clinicians in emergency departments include identifying which patients have traumatic brain injury, and which patients can safely be sent home. Traumatic brain injuries may exist with subtle symptoms or signs, but can still lead to adverse outcomes. Despite the existence of several high quality clinical practice guidelines, internationally and in Australia, research shows inconsistent implementation of these recommendations. The aim of this trial is to test the effectiveness of a targeted, theory- and evidence-informed implementation intervention to increase the uptake of three key clinical recommendations regarding the emergency department management of adult patients (18 years of age or older) who present following mild head injuries (concussion), compared with passive dissemination of these recommendations. The primary objective is to establish whether the intervention is effective in increasing the percentage of patients for which appropriate post-traumatic amnesia screening is performed. Methods/design The design of this study is a cluster randomised trial. We aim to include 34 Australian 24-hour emergency departments, which will be randomised to an intervention or control group. Control group departments will receive a copy of the most recent Australian evidence-based clinical practice guideline on the acute management of patients with mild head injuries. The intervention group will receive an implementation intervention based on an analysis of influencing factors, which include local stakeholder meetings, identification of nursing and medical opinion leaders in each site, a train-the-trainer day and standardised education and interactive workshops delivered by the opinion leaders during a 3 month period of time. Clinical practice outcomes will be collected retrospectively from medical records by independent chart auditors over the 2 month period following

  3. The prevention access and risk taking in young people (PARTY project protocol: A cluster randomised controlled trial of health risk screening and motivational interviewing for young people presenting to general practice

    Directory of Open Access Journals (Sweden)

    Sanci Lena

    2012-06-01

    Full Text Available Abstract Background There are growing worldwide concerns about the ability of primary health care systems to manage the major burden of illness in young people. Over two thirds of premature adult deaths result from risks that manifest in adolescence, including injury, neuropsychiatric problems and consequences of risky behaviours. One policy response is to better reorientate primary health services towards prevention and early intervention. Currently, however, there is insufficient evidence to support this recommendation for young people. This paper describes the design and implementation of a trial testing an intervention to promote psychosocial risk screening of all young people attending general practice and to respond to identified risks using motivational interviewing. Main outcomes: clinicians’ detection of risk-taking and emotional distress, young people’s intention to change and reduction of risk taking. Secondary outcomes: pathways to care, trust in the clinician and likelihood of returning for future visits. The design of the economic and process evaluation are not detailed in this protocol. Methods PARTY is a cluster randomised trial recruiting 42 general practices in Victoria, Australia. Baseline measures include: youth friendly practice characteristics; practice staff’s self-perceived competency in young people’s care and clinicians’ detection and response to risk taking behaviours and emotional distress in 14–24 year olds, attending the practice. Practices are then stratified by a social disadvantage index and billing methods and randomised. Intervention practices receive: nine hours of training and tools; feedback of their baseline data and two practice visits over six weeks. Comparison practices receive a three hour seminar in youth friendly practice only. Six weeks post-intervention, 30 consecutive young people are interviewed post-consultation from each practice and followed-up for self-reported risk taking

  4. 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

    Directory of Open Access Journals (Sweden)

    Taft Angela J

    2012-09-01

    Full Text Available Abstract Background 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. Methods/design 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

  5. The impact of training non-physician clinicians in Malawi on maternal and perinatal mortality: a cluster randomised controlled evaluation of the enhancing training and appropriate technologies for mothers and babies in Africa (ETATMBA project

    Directory of Open Access Journals (Sweden)

    Ellard David

    2012-10-01

    Full Text Available Abstract Background Maternal mortality in much of sub-Saharan Africa is very high whereas there has been a steady decline in over the past 60 years in Europe. Perinatal mortality is 12 times higher than maternal mortality accounting for about 7 million neonatal deaths; many of these in sub-Saharan countries. Many of these deaths are preventable. Countries, like Malawi, do not have the resources nor highly trained medical specialists using complex technologies within their healthcare system. Much of the burden falls on healthcare staff other than doctors including non-physician clinicians (NPCs such as clinical officers, midwives and community health-workers. The aim of this trial is to evaluate a project which is training NPCs as advanced leaders by providing them with skills and knowledge in advanced neonatal and obstetric care. Training that will hopefully be cascaded to their colleagues (other NPCs, midwives, nurses. Methods/design This is a cluster randomised controlled trial with the unit of randomisation being the 14 districts of central and northern Malawi (one large district was divided into two giving an overall total of 15. Eight districts will be randomly allocated the intervention. Within these eight districts 50 NPCs will be selected and will be enrolled on the training programme (the intervention. Primary outcome will be maternal and perinatal (defined as until discharge from health facility mortality. Data will be harvested from all facilities in both intervention and control districts for the lifetime of the project (3–4 years and comparisons made. In addition a process evaluation using both quantitative and qualitative (e.g. interviews will be undertaken to evaluate the intervention implementation. Discussion Education and training of NPCs is a key to improving healthcare for mothers and babies in countries like Malawi. Some of the challenges faced are discussed as are the potential limitations. It is hoped that the findings

  6. The design of the SAFE or SORRY? study: a cluster randomised trial on the development and testing of an evidence based inpatient safety program for the prevention of adverse events

    Directory of Open Access Journals (Sweden)

    Koopmans Raymond TCM

    2009-04-01

    Full Text Available Abstract Background Patients in hospitals and nursing homes are at risk of the development of, often preventable, adverse events (AEs, which threaten patient safety. Guidelines for prevention of many types of AEs are available, however, compliance with these guidelines appears to be lacking. Besides general barriers that inhibit implementation, this non-compliance is associated with the large number of guidelines competing for attention. As implementation of a guideline is time-consuming, it is difficult for organisations to implement all available guidelines. Another problem is lack of feedback about performance using quality indicators of guideline based care and lack of a recognisable, unambiguous system for implementation. A program that allows organisations to implement multiple guidelines simultaneously may facilitate guideline use and thus improve patient safety. The aim of this study is to develop and test such an integral patient safety program that addresses several AEs simultaneously in hospitals and nursing homes. This paper reports the design of this study. Methods and design The patient safety program addresses three AEs: pressure ulcers, falls and urinary tract infections. It consists of bundles and outcome and process indicators based on the existing evidence based guidelines. In addition it includes a multifaceted tailored implementation strategy: education, patient involvement, and a computerized registration and feedback system. The patient safety program was tested in a cluster randomised trial on ten hospital wards and ten nursing home wards. The baseline period was three months followed by the implementation of the patient safety program for fourteen months. Subsequently the follow-up period was nine months. Primary outcome measure was the incidence of AEs on every ward. Secondary outcome measures were the utilization of preventive interventions and the knowledge of nurses regarding the three topics. Randomisation took

  7. The ADDITION-Cambridge trial protocol: a clusterrandomised controlled trial of screening for type 2 diabetes and intensive treatment for screen-detected patients

    Directory of Open Access Journals (Sweden)

    Kinmonth Ann

    2009-05-01

    Full Text Available Abstract Background The increasing prevalence of type 2 diabetes poses a major public health challenge. Population-based screening and early treatment for type 2 diabetes could reduce this growing burden. However, the benefits of such a strategy remain uncertain. Methods and design The ADDITION-Cambridge study aims to evaluate the effectiveness and cost-effectiveness of (i a stepwise screening strategy for type 2 diabetes; and (ii intensive multifactorial treatment for people with screen-detected diabetes in primary care. 63 practices in the East Anglia region participated. Three undertook the pilot study, 33 were allocated to three groups: no screening (control, screening followed by intensive treatment (IT and screening plus routine care (RC in an unbalanced (1:3:3 randomisation. The remaining 27 practices were randomly allocated to IT and RC. A risk score incorporating routine practice data was used to identify people aged 40–69 years at high-risk of undiagnosed diabetes. In the screening practices, high-risk individuals were invited to take part in a stepwise screening programme. In the IT group, diabetes treatment is optimised through guidelines, target-led multifactorial treatment, audit, feedback, and academic detailing for practice teams, alongside provision of educational materials for newly diagnosed participants. Primary endpoints are modelled cardiovascular risk at one year, and cardiovascular mortality and morbidity at five years after diagnosis of diabetes. Secondary endpoints include all-cause mortality, development of renal and visual impairment, peripheral neuropathy, health service costs, self-reported quality of life, functional status and health utility. Impact of the screening programme at the population level is also assessed through measures of mortality, cardiovascular morbidity, health status and health service use among high-risk individuals. Discussion ADDITION-Cambridge is conducted in a defined high-risk group

  8. Protocol for a cluster randomised trial of a communication skills intervention for physicians to facilitate survivorship transition in patients with lymphoma

    Science.gov (United States)

    Parker, Patricia A; Banerjee, Smita C; Matasar, Matthew J; Bylund, Carma L; Franco, Kara; Li, Yuelin; Levin, Tomer T; Jacobsen, Paul B; Astrow, Alan B; Leventhal, Howard; Horwitz, Steven; Kissane, David W

    2016-01-01

    Introduction Survivors of cancer often describe a sense of abandonment post-treatment, with heightened worry, uncertainty, fear of recurrence and limited understanding of what lies ahead. This study examines the efficacy of a communication skills training (CST) intervention to help physicians address survivorship issues and introduce a new consultation focused on the use of a survivorship care plan for patients with Hodgkin's lymphoma and diffuse large B-cell lymphoma. Methods and analysis Specifically, this randomised, 4-site trial will test the efficacy of a survivorship planning consultation (physicians receive CST and apply these skills in a new survivorship-focused office visit using a survivorship plan) with patients who have achieved complete remission after completion of first-line therapy versus a control arm in which physicians are trained to subsequently provide a time-controlled, manualised wellness rehabilitation consultation focused only on discussion of healthy nutrition and exercise as rehabilitation postchemotherapy. The primary outcome for physicians will be uptake and usage of communication skills and maintenance of these skills over time. The primary outcome for patients is changes in knowledge about lymphoma and adherence to physicians’ recommendations (eg, pneumococcus and influenza vaccinations); secondary outcomes will include perceptions of the doctor–patient relationship, decreased levels of cancer worry and depression, quality of life changes, satisfaction with care and usage of healthcare. This study will also examine the moderators and mediators of change within our theoretical model derived from Leventhal's Common-Sense Model of health beliefs. Ethics and dissemination This study was approved by the Institutional Review Boards at Memorial Sloan Kettering Cancer Centers and all other participating sites. This work is funded by the National Cancer Institute (R01 CA 151899 awarded to DWK and SH as coprincipal investigators). The

  9. Improving the counselling skills of lay counsellors in antiretroviral adherence settings: a cluster randomised controlled trial in the Western Cape, South Africa.

    Science.gov (United States)

    Dewing, Sarah; Mathews, Cathy; Schaay, Nikki; Cloete, Allanise; Simbayi, Leickness; Louw, Johann

    2015-01-01

    Little research has investigated interventions to improve the delivery of counselling in health care settings. We determined the impact of training and supervision delivered as part of the Options: Western Cape project on lay antiretroviral adherence counsellors' practice. Four NGOs employing 39 adherence counsellors in the Western Cape were randomly allocated to receive 53 h of training and supervision in Options for Health, an intervention based on the approach of Motivational Interviewing. Five NGOs employing 52 adherence counsellors were randomly allocated to the standard care control condition. Counselling observations were analysed for 23 intervention and 32 control counsellors. Intervention counsellors' practice was more consistent with a client-centred approach than control counsellors', and significantly more intervention counsellors engaged in problem-solving barriers to adherence (91 vs. 41 %). The Options: Western Cape training and supervision package enabled lay counsellors to deliver counselling for behaviour change in a manner consistent with evidence-based approaches.

  10. 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

    Science.gov (United States)

    Okesola, Nonhlanhla; Tanser, Frank; Thiebaut, Rodolphe; Rekacewicz, Claire; Newell, Marie-Louise

    2016-01-01

    Background 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. Methods and Findings 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

  11. Study protocol. IDUS - Instrumental delivery & ultrasound: a multi-centre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery.

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2012-01-01

    Instrumental deliveries are commonly performed in the United Kingdom and Ireland, with rates of 12 - 17% in most centres. Knowing the exact position of the fetal head is a pre-requisite for safe instrumental delivery. Traditionally, diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. However, the accuracy of transvaginal digital examination can be unreliable and varies between 20% and 75%. Failure to identify the correct fetal head position increases the likelihood of failed instrumental delivery with the additional morbidity of sequential use of instruments or second stage caesarean section. The use of ultrasound in determining the position of the fetal head has been explored but is not part of routine clinical practice.

  12. A multi-component integrated approach for the elimination of schistosomiasis in the People's Republic of China: design and baseline results of a 4-year cluster-randomised intervention trial.

    Science.gov (United States)

    Gray, Darren J; Li, Yue-Sheng; Williams, Gail M; Zhao, Zheng-Yuan; Harn, Donald A; Li, Sheng-Ming; Ren, Mao-Yuan; Feng, Zeng; Guo, Feng-Ying; Guo, Jia-Gang; Zhou, Jie; Dong, Yu-Lan; Li, Yuan; Ross, Allen G; McManus, Donald P

    2014-08-01

    Despite major successes in its control over the past 50years, schistosomiasis japonica continues to be a public health problem in the People's Republic of China (P.R. China). Historically, the major endemic foci occur in the lakes and marshlands along the Yangtze River, areas where transmission interruption has proven difficult. The current endemic situation may alter due to the closure of the Three Gorges Dam. Considerable environmental and ecological changes are anticipated that may result in new habitats for the oncomelanid intermediate snail host of Schistosoma japonicum (Sj), thereby increasing the risk of transmission. The current national control program for P.R. China involves a multi-component integrated strategy but, despite targeting multiple transmission pathways, certain challenges remain. As the Chinese government pushes towards elimination, there is a requirement for additional tools, such as vaccination, for long-term prevention. Whereas the zoonotic nature of schistosomiasis japonica adds to the complexity of control, it provides a unique opportunity to develop a transmission blocking vaccine targeting bovines to assist in the prevention of human infection and disease. Mathematical modelling has shown that control options targeting the various transmission pathways of schistosomiasis japonica and incorporating bovine vaccination, mass human chemotherapy and mollusciciding could lead to its elimination from P.R. China. Here we present the study design and baseline results of a four-year cluster randomised intervention trial we are undertaking around the schistosomiasis-endemic Dongting Lake in Hunan Province aimed at determining the impact on schistosome transmission of the multi-component integrated control strategy, including bovine vaccination using a heterologous "prime-boost" delivery platform based on the previously tested SjCTPI vaccine. PMID:24929133

  13. A cluster randomised trial of a school-based intervention to prevent decline in adolescent physical activity levels: study protocol for the ‘Physical Activity 4 Everyone’ trial

    Directory of Open Access Journals (Sweden)

    Sutherland Rachel

    2013-01-01

    Full Text Available Abstract Background Adolescence is an established period of physical activity decline. Multi-component school-based interventions have the potential to slow the decline in adolescents’ physical activity; however, few interventions have been conducted in schools located in low-income or disadvantaged communities. This study aims to assess the effectiveness of a multi-component school-based intervention in reducing the decline in physical activity among students attending secondary schools located in disadvantaged communities. Methods/Design The cluster randomised trial will be conducted with 10 secondary schools located in selected regions of New South Wales, Australia. The schools will be selected from areas that have a level of socio-economic status that is below the state average. Five schools will be allocated to receive an intervention based on the Health Promoting Schools framework, and will be supported by a part-time physical activity consultant placed in intervention schools who will implement a range of intervention adoption strategies. Study measures will be taken at baseline when students are in Year 7 (12–13 years and again after 12- and 24-months. The primary outcome, minutes of moderate- to-vigorous- intensity physical activity per day and percentage of time in moderate- to vigorous-intensity physical activity (MVPA, will be objectively assessed using accelerometers (Actigraph GT3x+. Group allocation and intervention delivery will commence after baseline data collection. The intervention will continue during school terms through to 24-month follow-up. Discussion The study will provide evidence regarding the effectiveness of a multi-component school-based intervention that includes an in-school physical activity consultant targeting the physical activity levels of adolescents in disadvantaged Australian secondary schools. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12612000382875.

  14. Rationale, design, and implementation protocol of the Dutch clinical practice guideline Pain in patients with cancer: a cluster randomised controlled trial with short message service (SMS and interactive voice response (IVR

    Directory of Open Access Journals (Sweden)

    te Boveldt Nienke

    2011-12-01

    Full Text Available Abstract Background One-half of patients with cancer have pain. In nearly one out of two cancer patients with pain, this was undertreated. Inadequate pain control still remains an important problem in this group of patients. Therefore, in 2008 a national, evidence-based multidisciplinary clinical practice guideline 'pain in patients with cancer' has been developed. Yet, publishing a guideline is not enough. Implementation is needed to improve pain management. An innovative implementation strategy, Short Message Service with Interactive Voice Response (SVS-IVR, has been developed and pilot tested. This study aims to evaluate on effectiveness of this strategy to improve pain reporting, pain measurement and adequate pain therapy. In addition, whether the active role of the patient and involvement of caregivers in pain management may change. Methods/design A cluster randomised controlled trial with two arms will be performed in six oncology outpatient clinics of hospitals in the Southeastern region of the Netherlands, with three hospitals in the intervention and three in the control condition. Follow-up measurements will be conducted in all hospitals to study the long-term effect of the intervention. The intervention includes training of professionals (medical oncologists, nurses, and general practitioners and SMS-IVR to report pain in patients with cancer to improve pain reporting by patients, pain management by medical oncologists, nurses, and general practitioners, and decrease pain intensity. Discussion This innovative implementation strategy with technical tools and the involvement of patients, may enhance the use of the guideline 'pain in patients with cancer' for pain management. Short Message Service alerts may serve as a tool to support self-management of patients. Therefore, the SMS-IVR intervention may increase the feeling of having control over one's life. Trail registration Netherlands Trial Register (NTR: NTR2739

  15. The effects of Nordic school meals on concentration and school performance in 8- to 11-year-old children in the OPUS School Meal Study: a cluster-randomised, controlled, cross-over trial.

    Science.gov (United States)

    Sørensen, Louise B; Dyssegaard, Camilla B; Damsgaard, Camilla T; Petersen, Rikke A; Dalskov, Stine-Mathilde; Hjorth, Mads F; Andersen, Rikke; Tetens, Inge; Ritz, Christian; Astrup, Arne; Lauritzen, Lotte; Michaelsen, Kim F; Egelund, Niels

    2015-04-28

    It is widely assumed that nutrition can improve school performance in children; however, evidence remains limited and inconclusive. In the present study, we investigated whether serving healthy school meals influenced concentration and school performance of 8- to 11-year-old Danish children. The OPUS (Optimal well-being, development and health for Danish children through a healthy New Nordic Diet) School Meal Study was a cluster-randomised, controlled, cross-over trial comparing a healthy school meal programme with the usual packed lunch from home (control) each for 3 months (NCT 01457794). The d2 test of attention, the Learning Rating Scale (LRS) and standard tests on reading and mathematics proficiency were administered at baseline and at the end of each study period. Intervention effects were evaluated using hierarchical mixed models. The school meal intervention did not influence concentration performance (CP; primary outcome, n 693) or processing speed; however, the decrease in error percentage was 0·18 points smaller (P<0·001) in the intervention period than in the control period (medians: baseline 2·03%; intervention 1·46%; control 1·37%). In contrast, the intervention increased reading speed (0·7 sentence, P=0·009) and the number of correct sentences (1·8 sentences, P<0·001), which corresponded to 11 and 25%, respectively, of the effect of one school year. The percentage of correct sentences also improved (P<0·001), indicating that the number correct improved relatively more than reading speed. There was no effect on overall math performance or outcomes from the LRS. In conclusion, school meals did not affect CP, but improved reading performance, which is a complex cognitive activity that involves inference, and increased errors related to impulsivity and inattention. These findings are worth examining in future trials. PMID:25791747

  16. Prescribing Data in General Practice Demonstration (PDGPD project - a cluster randomised controlled trial of a quality improvement intervention to achieve better prescribing for chronic heart failure and hypertension

    Directory of Open Access Journals (Sweden)

    Williamson Margaret

    2012-08-01

    Full Text Available Abstract Background Research literature consistently documents that scientifically based therapeutic recommendations are not always followed in the hospital or in the primary care setting. Currently, there is evidence that some general practitioners in Australia are not prescribing appropriately for patients diagnosed with 1 hypertension (HT and 2 chronic heart failure (CHF. The objectives of this study were to improve general practitioner’s drug treatment management of these patients through feedback on their own prescribing and small group discussions with peers and a trained group facilitator. The impact evaluation includes quantitative assessment of prescribing changes at 6, 9, 12 and 18 months after the intervention. Methods A pragmatic multi site cluster RCT began recruiting practices in October 2009 to evaluate the effects of a multi-faceted quality improvement (QI intervention on prescribing practice among Australian general practitioners (GP in relation to patients with CHF and HT. General practices were recruited nationally through General Practice Networks across Australia. Participating practices were randomly allocated to one of three groups: two groups received the QI intervention (the prescribing indicator feedback reports and small group discussion with each group undertaking the clinical topics (CHF and HT in reverse order to the other. The third group was waitlisted to receive the intervention 6 months later and acted as a “control” for the other two groups. De-identified data on practice, doctor and patient characteristics and their treatment for CHF and HT are extracted at six-monthly intervals before and after the intervention. Post-test comparisons will be conducted between the intervention and control arms using intention to treat analysis and models that account for clustering of practices in a Network and clustering of patients within practices and GPs. Discussion This paper describes the study protocol for a

  17. Effectiveness of Onsite Nurse Mentoring in Improving Quality of Institutional Births in the Primary Health Centres of High Priority Districts of Karnataka, South India: A Cluster Randomized Trial

    Science.gov (United States)

    Bradley, Janet; Mony, Prem; Cunningham, Troy; Washington, Maryann; Bhat, Swarnarekha; Rao, Suman; Thomas, Annamma; S, Rajaram; Kar, Arin; N, Swaroop; B M, Ramesh; H L, Mohan; Fischer, Elizabeth; Crockett, Maryanne; Blanchard, James; Moses, Stephen; Avery, Lisa

    2016-01-01

    Background In India, although the proportion of institutional births is increasing, there are concerns regarding quality of care. We assessed the effectiveness of a nurse-led onsite mentoring program in improving quality of care of institutional births in 24/7 primary health centres (PHCs that are open 24 hours a day, 7 days a week) of two high priority districts in Karnataka state, South India. Primary outcomes were improved facility readiness and provider preparedness in managing institutional births and associated complications during child birth. Methods All functional 24/7 PHCs in the two districts were included in the study. We used a parallel, cluster randomized trial design in which 54 of 108 facilities received six onsite mentoring visits, along with an initial training update and specially designed case sheets for providers; the control arm received just the initial training update and the case sheets. Pre- and post-intervention surveys were administered in April-2012 and August-2013 using facility audits, provider interviews and case sheet audits. The provider interviews were administered to all staff nurses available at the PHCs and audits were done of all the filled case sheets during the month prior to data collection. In addition, a cost analysis of the intervention was undertaken. Results Between the surveys, we achieved coverage of 100% of facilities and 91.2% of staff nurse interviews. Since the case sheets were newly designed, case-sheet audit data were available only from the end line survey for about 80.2% of all women in the intervention facilities and 57.3% in the control facilities. A higher number of facilities in the intervention arm had all appropriate drugs, equipment and supplies to deal with gestational hypertension (19 vs.3, OR (odds ratio) 9.2, 95% C.I 2.5 to33.6), postpartum haemorrhage (29 vs. 12, OR 3.7, 95% C.I 1.6 to8.3); and obstructed labour (25 vs.9, OR 3.4, 95% CI 1.6 to8.3). The providers in the intervention arm had better

  18. Prophylactic antibiotic regimens in tumour surgery (PARITY) A PILOT MULTICENTRE RANDOMISED CONTROLLED TRIAL

    NARCIS (Netherlands)

    Ghert, M.; Bhandari, M.; Deheshi, B.; Guyatt, G.; Holt, G.; O'Shea, T.; Randall, R. L.; Thabane, L.; Wunder, J.; Evaniew, N.; McKay, P.; Schneider, P.; Turcotte, R.; Madden, K.; Scott, T.; Sprague, S.; Simunovic, N.; Swinton, M.; Racano, A.; Heels-Ansdell, D.; Buckingham, L.; Rose, P.; Brigman, B.; Pullenayegum, E.; Ghert, M.; Evaniew, N.; Mckay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Biljan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; St Yves, H.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, K.; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Chai, Y.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Ghert, M.; Evaniew, N.; McKay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Bil-Jan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; Yves, H. St.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, Kristine; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Tran, N.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Geller, D.; Hoang, B.; Tingling, J.; Solorzano, C.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Puloski, S.; Monument, M.; Carcary, K.; Cameron, C.; Aboulafia, A.; Loo-Mis, M.; Bosley, J.; Bonvegna, R.; Kassa, M.; Damron, T.; Craig, T.; Reale, M.; Goodman, H. J.; Culbertson, M. Deza; Caruso, P.; Garling, E.; Schwab, J.; Fiore, A.; Phukan, R.; Park, C.; Joshi, L.; Aboulafia, A.; Wallace, M.; Flack, J.; Vaughan, K.; Avergas, A.; Brady, M.; Brown, S.; Schadie, N.; Battersby, R.; Weiss, K.; Goodman, M.; Heyl, A.; Yeschke, C. A.; Sumic, P.; Dudgeon, M.; Prosser, R.; Korenoski, C.; DiCaprio, M.; Palmer, B.; Cioppa, E.; Schaeffer, T. M.; Paul, P.; Toreson, J.; Cummings, J.; Schwartz, L.; Zahner, B.; Morris, C.; Laljani, V.; Mesko, N.; Joyce, M.; Lietman, S.; Wustrack, R.; O'Donnell, R.; Stevenson, C.; Carmody, E.; Tyler, W.; McIntyre, A.; Spiguel, A.; Scarborough, M.; Gibbs, C. P.; Steshyn, J.; Nunn, B.; Rosenthal, H.; Haynes, K.; Leddy, L.; Walton, Z.; Doung, Y-C.; Hayden, J.; Velez, R.; Aguirre, M.; Perez, M.; Barrera, S.; Garca Lopez, A.; Grimer, R.; Dunn, K.; Virdee, H.; Rankin, K.; Beckingsale, T.; Gerrand, C.; Campbell, I.; Allen, M.; Khan, S. Alam; Bakshi, S.; Rastogi, S.; Poudel, R.; Kumar, V. Sampath; Rai, A.; Baptista, A. M.; de Camargo, O. P.; Marais, L.; Rodseth, R.; Ferreira, N.; Rajah, C.; Gumede, S.; Gortzak, Y.; Sternheim, A.; Bickels, J.; Kolander, Y.; Lev, S.; Hettwer, W.; Petersen, M. M.; Grum-Schwensen, T.; Jutte, P.; Ploegmakers, J. J. W.; Stevens, M.; Mahendra, A.; Gupta, S.; Bergovec, M.; Leithner, A.; Funovics, P.; Dijkstra, P. D. S.; Van De Sande, M.; Hoogenstraaten, A.; Leijerzapf, N.; Steadman, P.; Steadman, P.; Boffano, M.; Piana, R.; Marone, S.; Albertini, U.; Boux, E.; Maiello, A.; Repsa, L.; Zile, S.; Aston, W.; Pollock, R.; Cool, P.; Gibbons, M.; Whit-Well, D.; Cosker, T.; Hemingway, J.; Porter, D.; Patton, S.; Navia, J.; Betancur, A. F.; Laitenen, M.; Pakarinen, K.; Nieminen, J.; Yla-Mononen, S.; Rautiainen, S.; Fiorenza, F.

    2015-01-01

    Objective Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a five-da

  19. Totally laparoscopic versus conventional ileoanal pouch procedure – design of a single-centre, expertise based randomised controlled trial to compare the laparoscopic and conventional surgical approach in patients undergoing primary elective restorative proctocolectomy- LapConPouch-Trial

    Directory of Open Access Journals (Sweden)

    Weitz Jürgen

    2006-11-01

    Full Text Available Abstract Background Restorative proctocolectomy is increasingly being performed minimal invasively but a totally laparoscopic technique has not yet been compared to the standard open technique in a randomized study. Methods/design This is a two armed, single centre, expertise based, preoperatively randomized, patient blinded study. It is designed as a two-group parallel superiority study. Power calculation revealed 80 patients per group in order to recruit the 65 patients to be analysed for the primary endpoint. The primary objective is to investigate intra-operative blood loss and the need for blood transfusions. We hypothesise that intra-operative blood loss and the need for peri-operative blood transfusions are significantly higher in the conventional group. Additionally a set of surgical and non-surgical parameters related to the operation will be analysed as secondary objectives. These will include operative time, complications, postoperative pain, lung function, postoperative length of hospital stay, a cosmetic score and pre-and postoperative quality of life. Discussion The trial will answer the question whether there is indeed an advantage in the laparoscopic group in regard to blood loss and the need for blood transfusions. Moreover, it will generate data on the safety and potential advantages and disadvantages of the minimally invasive approach. Trial registration : ISCRTN61411448

  20. The role of facemasks and hand hygiene in the prevention of influenza transmission in households: results from a cluster randomised trial; Berlin, Germany, 2009-2011

    Directory of Open Access Journals (Sweden)

    Suess Thorsten

    2012-01-01

    Full Text Available Abstract Background Previous controlled studies on the effect of non-pharmaceutical interventions (NPI - namely the use of facemasks and intensified hand hygiene - in preventing household transmission of influenza have not produced definitive results. We aimed to investigate efficacy, acceptability, and tolerability of NPI in households with influenza index patients. Methods We conducted a cluster randomized controlled trial during the pandemic season 2009/10 and the ensuing influenza season 2010/11. We included households with an influenza positive index case in the absence of further respiratory illness within the preceding 14 days. Study arms were wearing a facemask and practicing intensified hand hygiene (MH group, wearing facemasks only (M group and none of the two (control group. Main outcome measure was laboratory confirmed influenza infection in a household contact. We used daily questionnaires to examine adherence and tolerability of the interventions. Results We recruited 84 households (30 control, 26 M and 28 MH households with 82, 69 and 67 household contacts, respectively. In 2009/10 all 41 index cases had a influenza A (H1N1 pdm09 infection, in 2010/11 24 had an A (H1N1 pdm09 and 20 had a B infection. The total secondary attack rate was 16% (35/218. In intention-to-treat analysis there was no statistically significant effect of the M and MH interventions on secondary infections. When analysing only households where intervention was implemented within 36 h after symptom onset of the index case, secondary infection in the pooled M and MH groups was significantly lower compared to the control group (adjusted odds ratio 0.16, 95% CI, 0.03-0.92. In a per-protocol analysis odds ratios were significantly reduced among participants of the M group (adjusted odds ratio, 0.30, 95% CI, 0.10-0.94. With the exception of MH index cases in 2010/11 adherence was good for adults and children, contacts and index cases. Conclusions Results suggest

  1. Improving patient adherence to lifestyle advice (IMPALA: a cluster-randomised controlled trial on the implementation of a nurse-led intervention for cardiovascular risk management in primary care (protocol

    Directory of Open Access Journals (Sweden)

    Grol Richard

    2008-01-01

    Full Text Available Abstract Background Many patients at high risk of cardiovascular diseases are managed and monitored in general practice. Recommendations for cardiovascular risk management, including lifestyle change, are clearly described in the Dutch national guideline. Although lifestyle interventions, such as advice on diet, physical exercise, smoking and alcohol, have moderate, but potentially relevant effects in these patients, adherence to lifestyle advice in general practice is not optimal. The IMPALA study intends to improve adherence to lifestyle advice by involving patients in decision making on cardiovascular prevention by nurse-led clinics. The aim of this paper is to describe the design and methods of a study to evaluate an intervention aimed at involving patients in cardiovascular risk management. Methods A cluster-randomised controlled trial in 20 general practices, 10 practices in the intervention arm and 10 in the control arm, starting on October 2005. A total of 720 patients without existing cardiovascular diseases but eligible for cardiovascular risk assessment will be recruited. In both arms, the general practitioners and nurses will be trained to apply the national guideline for cardiovascular risk management. Nurses in the intervention arm will receive an extended training in risk assessment, risk communication, the use of a decision aid and adapted motivational interviewing. This communication technique will be used to support the shared decision-making process about risk reduction. The intervention comprises 2 consultations and 1 follow-up telephone call. The nurses in the control arm will give usual care after the risk estimation, according to the national guideline. Primary outcome measures are self-reported adherence to lifestyle advice and drug treatment. Secondary outcome measures are the patients' perception of risk and their motivation to change their behaviour. The measurements will take place at baseline and after 12 and 52

  2. Effect of salt reduction on iodine status assessed by 24 hour urinary iodine excretion in children and their families in northern China: a substudy of a cluster randomised controlled trial

    Science.gov (United States)

    He, Feng J; Ma, Yuan; Feng, Xiangxian; Zhang, Wanqi; Lin, Laixiang; Guo, Xiaohui; Zhang, Jing; Niu, Wenyi; Wu, Yangfeng; MacGregor, Graham A

    2016-01-01

    Objective To study the effect of salt reduction on iodine status and to determine whether iodine consumption was still adequate after salt reduction in a population where universal salt iodisation is mandatory. Design A substudy of a cluster randomised controlled trial, with schools randomly assigned to either the intervention or the control group. Setting 28 primary schools in Changzhi, northern China. Participants 279 children in grade 5 of primary school (mean age: 10.1); 553 adults (age: 43.8). Intervention Children were educated about the harmful effects of salt and how to reduce salt intake using the schools' usual health education lessons. Children then delivered the message to their families. The duration was 1 school term (≈3.5 months). Main outcome measure Difference between the intervention and control groups in the change of iodine intake as measured by repeat 24 hour urinary iodine from baseline to the end of the trial. Results At baseline, the mean salt intake was 7.0±2.5 g/day in children and 11.7±4.4 g/day in adults and the median iodine intake was 165.1 μg/day (IQR: 122.6–216.7) and 280.7 μg/day (IQR: 205.1–380.9) in children and adults, respectively. At the end of the study, salt and iodine decreased in the intervention compared with control group. The mean effect on salt for intervention versus control was −1.9 g/day (95% CI −2.6 to −1.3) in children and −2.9 g/day (95% CI −3.7 to −2.2) in adults. The mean effect on iodine was −19.3% (95% CI −29.4% to −7.7%) in children and −11.4% (95% CI −20.3% to −1.5%) in adults. Conclusions With ≈25% reduction in salt intake, there was a significant reduction in iodine consumption in northern China where salt is iodised. Despite this, iodine intake was still adequate, and well above the estimated average requirement. Our findings indicate that reducing salt to the WHO's target—30% reduction by 2025—will not compromise iodine status. Trial registration

  3. Effectiveness of a universal parental support programme to promote healthy dietary habits and physical activity and to prevent overweight and obesity in 6-year-old children: the Healthy School Start Study, a cluster-randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Gisela Nyberg

    Full Text Available To develop and evaluate the effectiveness of a parental support programme to promote healthy dietary and physical activity habits and to prevent overweight and obesity in Swedish children.A cluster-randomised controlled trial was carried out in areas with low to medium socio-economic status. Participants were six-year-old children (n = 243 and their parents. Fourteen pre-school classes were randomly assigned to intervention (n = 7 and control groups (n = 7. The intervention lasted for 6 months and included: 1 Health information for parents, 2 Motivational Interviewing with parents and 3 Teacher-led classroom activities with children. Physical activity was measured by accelerometry, dietary and physical activity habits and parental self-efficacy through a questionnaire. Body weight and height were measured and BMI standard deviation score was calculated. Measurements were conducted at baseline, post-intervention and at 6-months follow-up. Group differences were examined using analysis of covariance and Poisson regression, adjusted for gender and baseline values.There was no significant intervention effect in the primary outcome physical activity. Sub-group analyses showed a significant gender-group interaction in total physical activity (TPA, with girls in the intervention group demonstrating higher TPA during weekends (p = 0.04, as well as in sedentary time, with boys showing more sedentary time in the intervention group (p = 0.03. There was a significantly higher vegetable intake (0.26 servings in the intervention group compared to the control group (p = 0.003. At follow-up, sub-group analyses showed a sustained effect for boys. The intervention did not affect the prevalence of overweight or obesity.It is possible to influence vegetable intake in children and girls' physical activity through a parental support programme. The programme needs to be intensified in order to increase effectiveness and sustain the effects long-term. These findings

  4. MOSAIC (MOthers' Advocates In the Community: protocol and sample description of a cluster randomised trial of mentor mother support to reduce intimate partner violence among pregnant or recent mothers

    Directory of Open Access Journals (Sweden)

    Taft Angela J

    2009-05-01

    Full Text Available Abstract Background Intimate partner violence (IPV is prevalent globally, experienced by a significant minority of women in the early childbearing years and is harmful to the mental and physical health of women and children. There are very few studies with rigorous designs which have tested the effectiveness of IPV interventions to improve the health and wellbeing of abused women. Evidence for the separate benefit to victims of social support, advocacy and non-professional mentoring suggested that a combined model may reduce the levels of violence, the associated mental health damage and may increase a woman's health, safety and connection with her children. This paper describes the development, design and implementation of a trial of mentor mother support set in primary care, including baseline characteristics of participating women. Methods/Design MOSAIC (MOtherS' Advocates In the Community was a cluster randomised trial embedded in general practice and maternal and child health (MCH nursing services in disadvantaged suburbs of Melbourne, Australia. Women who were pregnant or with infants, identified as abused or symptomatic of abuse, were referred by IPV-trained GPs and MCH nurses from 24 general practices and eight nurse teams from January 2006 to December 2007. Women in the intervention arm received up to 12 months support from trained and supported non-professional mentor mothers. Vietnamese health professionals also referred Vietnamese women to bilingual mentors in a sub-study. Baseline and follow-up surveys at 12 months measured IPV (CAS, depression (EPDS, general health (SF-36, social support (MOS-SF and attachment to children (PSI-SF. Significant development and piloting occurred prior to trial commencement. Implementation interviews with MCH nurses, GPs and mentors assisted further refinement of the intervention. In-depth interviews with participants and mentors, and follow-up surveys of MCH nurses and GPs at trial conclusion will

  5. Mothers' AdvocateS In the Community (MOSAIC- non-professional mentor support to reduce intimate partner violence and depression in mothers: a cluster randomised trial in primary care

    Directory of Open Access Journals (Sweden)

    Gold Lisa

    2011-03-01

    Full Text Available Abstract Background Effective interventions to increase safety and wellbeing of mothers experiencing intimate partner violence (IPV are scarce. As much attention is focussed on professional intervention, this study aimed to determine the effectiveness of non-professional mentor support in reducing IPV and depression among pregnant and recent mothers experiencing, or at risk of IPV. Methods MOSAIC was a cluster randomised trial in 106 primary care (maternal and child health nurse and general practitioner clinics in Melbourne, Australia. 63/106 clinics referred 215 eligible culturally and linguistically diverse women between January 2006 and December 2007. 167 in the intervention (I arm, and 91 in the comparison (C arm. 174 (80.9% were recruited. 133 (76.4% women (90 I and 43 C completed follow-up at 12 months. Intervention: 12 months of weekly home visiting from trained and supervised local mothers, (English & Vietnamese speaking offering non-professional befriending, advocacy, parenting support and referrals. Main outcome measures: Primary outcomes; IPV (Composite Abuse Scale CAS and depression (Edinburgh Postnatal Depression Scale EPDS; secondary measures included wellbeing (SF-36, parenting stress (PSI-SF and social support (MOS-SF at baseline and follow-up. Analysis: Intention-to-treat using multivariable logistic regression and propensity scoring. Results There was evidence of a true difference in mean abuse scores at follow-up in the intervention compared with the comparison arm (15.9 vs 21.8, AdjDiff -8.67, CI -16.2 to -1.15. There was weak evidence for other outcomes, but a trend was evident favouring the intervention: proportions of women with CAS scores ≥7, 51/88 (58.4% vs 27/42 (64.3% AdjOR 0.47, CI 0.21 to 1.05; depression (EPDS score ≥13 (19/85, 22% (I vs 14/43, 33% (C; AdjOR 0.42, CI 0.17 to 1.06; physical wellbeing mean scores (PCS-SF36: AdjDiff 2.79; CI -0.40 to 5.99; mental wellbeing mean scores (MCS-SF36: AdjDiff 2.26; CI -1

  6. Randomised clinical trial

    DEFF Research Database (Denmark)

    Reimer, C; Lødrup, A B; Smith, G;

    2016-01-01

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

  7. Study protocol. ECSSIT - Elective Caesarean Section Syntocinon Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section.

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2012-02-01

    BACKGROUND: Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4-10 minutes) therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion. METHODS AND DESIGN: A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml). A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha. DISCUSSION: It is both important and timely that we evaluate the optimal approach to the management of the third stage at

  8. Study protocol. ECSSIT - Elective Caesarean Section Syntocinon Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section.

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2009-01-01

    BACKGROUND: Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4-10 minutes) therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion. METHODS AND DESIGN: A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml). A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha. DISCUSSION: It is both important and timely that we evaluate the optimal approach to the management of the third stage at

  9. The effect of changing movement and posture using motion-sensor biofeedback, versus guidelines-based care, on the clinical outcomes of people with sub-acute or chronic low back pain-a multicentre, cluster-randomised, placebo-controlled, pilot trial

    DEFF Research Database (Denmark)

    Kent, Peter; Laird, Robert; Haines, Terry

    2015-01-01

    sample size calculations for a fully powered trial. METHODS: A multicentre (8 clinics), cluster-randomised, placebo-controlled pilot trial compared two groups of patients seeking medical or physiotherapy primary care for sub-acute and chronic back pain. It was powered for longitudinal analysis......BACKGROUND: The aims of this pilot trial were to (i) test the hypothesis that modifying patterns of painful lumbo-pelvic movement using motion-sensor biofeedback in people with low back pain would lead to reduced pain and activity limitation compared with guidelines-based care, and (ii) facilitate......, but not for adjusted single-time point comparisons. The intervention group (n = 58) received modification of movement patterns augmented by motion-sensor movement biofeedback (ViMove, dorsaVi.com) plus guidelines-based medical or physiotherapy care. The control group (n = 54) received a placebo (wearing the motion...

  10. Magnetic susceptibility of Co sup 2 sup + pairs in [Co sub 2 (ox)tpmc](ClO sub 4) sub 2 centre dot 3H sub 2 O cluster complex

    CERN Document Server

    Spasojevic, V; Sovilj, S P; Mrozinski, J

    2000-01-01

    Calculation of the magnetic susceptibility of Co sup 2 sup + pairs in the recently synthesized cobaltous cluster complex [Co sub 2 (ox)tpmc](ClO sub 4) sub 2 centre dot 3H sub 2 O has been conducted by the use of two different theoretical models. The calculated results were compared to the experimental data collected in a wide temperature region. Conclusions on both the magnetic properties of Co sup 2 sup + dimers and the validity of the proposed models have been drawn. In the temperature region above chi(T) maximum, the best results are obtained with the Heisenberg model that includes spin-orbit coupling and excited single-ion levels. In the low-temperature region anisotropy of the magnetic properties dominates and Ising dimer ground-state model gives a more appropriate description. Obtained g-values (g sub p sub a sub r sub a sub l sub l sub e sub l a=5.67, g sub p sub a sub r sub a sub l sub l sub e sub l b=5.73, and g sub p sub e sub r sub p sub e sub n sub d sub i sub c sub u sub l sub a sub r =1.54) con...

  11. 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

  12. 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

    Directory of Open Access Journals (Sweden)

    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

  13. CMS Centre at CERN

    CERN Multimedia

    2007-01-01

    A new "CMS Centre" is being established on the CERN Meyrin site by the CMS collaboration. It will be a focal point for communications, where physicists will work together on data quality monitoring, detector calibration, offline analysis of physics events, and CMS computing operations. Construction of the CMS Centre begins in the historic Proton Synchrotron (PS) control room. The historic Proton Synchrotron (PS) control room, Opened by Niels Bohr in 1960, will be reused by CMS to built its control centre. TThe LHC@FNAL Centre, in operation at Fermilab in the US, will work very closely with the CMS Centre, as well as the CERN Control Centre. (Photo Fermilab)The historic Proton Synchrotron (PS) control room is about to start a new life. Opened by Niels Bohr in 1960, the room will be reused by CMS to built its control centre. When finished, it will resemble the CERN Contro...

  14. Water is a safe and effective alternative to sterile normal saline for wound irrigation prior to suturing: a prospective, double-blind, randomised, controlled clinical trial

    OpenAIRE

    Weiss, Eric Alan; Oldham, George; Lin, Michelle; Foster, Tammy; Quinn, James Victor

    2013-01-01

    Objective To determine if there is a significant difference in the infection rates of wounds irrigated with sterile normal saline (SS) versus tap water (TW), before primary wound closure. Design Single centre, prospective, randomised, double-blind controlled trial. Wound irrigation solution type was computer randomised and allocation was done on a sequential basis. Setting Stanford University Medical Center Department of Emergency Medicine. Participants Patients older than 1 year of age, who ...

  15. Anger management for people with mild to moderate learning disabilities: Study protocol for a multi-centre cluster randomized controlled trial of a manualized intervention delivered by day-service staff

    Directory of Open Access Journals (Sweden)

    Nuttall Jacqueline

    2011-02-01

    Full Text Available Abstract Background Cognitive behaviour therapy (CBT is the treatment of choice for common mental health problems, but this approach has only recently been adapted for people with learning disabilities, and there is a limited evidence base for the use of CBT with this client group. Anger treatment is the one area where there exists a reasonable number of small controlled trials. This study will evaluate the effectiveness of a manualized 12-week CBT intervention for anger. The intervention will be delivered by staff working in the day services that the participants attend, following training to act as 'lay therapists' by a Clinical Psychologist, who will also provide supervision. Methods/Design This is a multi-centre cluster randomized controlled trial of a group intervention versus a 'support as usual' waiting-list control group, with randomization at the level of the group. Outcomes will be assessed at the end of the intervention and again 6-months later. After completion of the 6-month follow-up assessments, the intervention will also be delivered to the waiting-list groups. The study will include a range of anger/aggression and mental health measures, some of which will be completed by service users and also by their day service key-workers and by home carers. Qualitative data will be collected to assess the impact of the intervention on participants, lay therapists, and services, and the study will also include a service-utilization cost and consequences analysis. Discussion This will be the first trial to investigate formally how effectively staff working in services providing day activities for people with learning disabilities are able to use a therapy manual to deliver a CBT based anger management intervention, following brief training by a Clinical Psychologist. The demonstration that service staff can successfully deliver anger management to people with learning disabilities, by widening the pool of potential therapists, would have

  16. Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial

    DEFF Research Database (Denmark)

    Jespersen, Christian M; Als-Nielsen, Bodil; Damgaard, Morten;

    2005-01-01

    Copenhagen University cardiology departments and a coordinating centre. PARTICIPANTS: 13,702 patients aged 18 to 85 years who had a discharge diagnosis of myocardial infarction or angina pectoris in 1993-9 and alive in August 1999 were invited by letter; 4373 were randomised. INTERVENTIONS: Two weeks...

  17. Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial

    DEFF Research Database (Denmark)

    Jespersen, CM; Als-Nielsen, B; Damgaard, M;

    2006-01-01

    Copenhagen University cardiology departments and a coordinating centre. PARTICIPANTS: 13,702 patients aged 18 to 85 years who had a discharge diagnosis of myocardial infarction or angina pectoris in 1993-9 and alive in August 1999 were invited by letter; 4373 were randomised. INTERVENTIONS: Two weeks...

  18. Evaluation of computer-tailored health education (‘E-health4Uth’ combined with personal counselling (‘E-health4Uth + counselling’ on adolescents’ behaviours and mental health status: design of a three-armed cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Bannink Rienke

    2012-12-01

    Full Text Available Abstract Background About 15% of adolescents in the Netherlands have mental health problems and many also have health risk behaviours such as excessive alcohol consumption, cigarette smoking, use of drugs, and having unsafe sex. Mental health problems and health risk behaviours may have adverse effects on the short and longer term. Therefore, in the Netherlands there is a considerable support for an additional public health examination at age 15–16 years. The study evaluates the effect of two options for such an additional examination. Adolescents in the ‘E-health4Uth’ group receive internet-based tailored health messages on their health behaviour and well-being. Adolescents in the ‘E-health4Uth + counselling’ group receive the computer-tailored messages combined with personal counselling for adolescents at risk of mental health problems. Methods and design A three-arm cluster randomised controlled trial will be conducted in the Netherlands among fourth-grade secondary school students. School classes are the unit of randomisation. Both intervention groups complete the computer-tailored program during one class session; the program focuses on nine topics related on health behaviour and well-being. For each topic a score is computed that can be compared with the Dutch health norms for adolescents. Based on the score, a message is presented that reflects the person’s current behaviour or well-being, the Dutch health norm, and offers advise to change unhealthy behaviour or to talk to a person they trust. Adolescents in the ‘E-health4Uth + counselling’ group are also invited for an appointment to see the nurse when they are at risk of mental health problems. The control group receives ‘care as usual’. The primary outcome measures are health behaviour (alcohol, drugs, smoking, safe sex and mental health status. The secondary outcome measure is health-related quality of life. Data will be collected with a questionnaire at baseline

  19. Client Centred Desing

    DEFF Research Database (Denmark)

    Ørngreen, Rikke; Nielsen, Janni; Levinsen, Karin

    2008-01-01

    In this paper we argue for the use of Client Centred preparation phases when designing complex systems. Through Client Centred Design human computer interaction can extend the focus on end-users to alse encompass the client's needs, context and resources.......In this paper we argue for the use of Client Centred preparation phases when designing complex systems. Through Client Centred Design human computer interaction can extend the focus on end-users to alse encompass the client's needs, context and resources....

  20. Canadian Irradiation Centre

    International Nuclear Information System (INIS)

    The Canadian Irradiation Centre is a non-profit cooperative project between Atomic Energy of Canada Limited, Radiochemical Company and Universite du Quebec, Institut Armand-Frappier, Centre for Applied Research in Food Science. The Centre's objectives are to develop, demonstrate and promote Canada's radiation processing technology and its applications by conducting applied research; training technical, professional and scientific personnel; educating industry and government; demonstrating operational and scientific procedures; developing processing procedures and standards, and performing product and market acceptance trials. This pamphlet outlines the history of radoation technology and the services offered by the Canadian Irradiation Centre

  1. Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-speficic sub-acute low back pain in the working population: cluster randomised trial

    OpenAIRE

    Roura-Olivan Mercè; Martín-Peñacoba Raquel; Pie-Oncins Magda; González-Moneo Maria J; Núñez-Juárez Esther; Montiel-Morillo Elena; Moix Jenny; Berenguera Anna; Balagué-Corbella Montserrat; Fernández-San-Martin Isabel; Rodriguez-Blanco Teresa; Núñez-Juárez Montse; Pujol-Ribera Enriqueta

    2010-01-01

    Abstract Background Non-specific low back pain is a common cause for consultation with the general practitioner, generating increased health and social costs. This study will analyse the effectiveness of a multidisciplinary intervention to reduce disability, severity of pain, anxiety and depression, to improve quality of life and to reduce the incidence of chronic low back pain in the working population with non-specific low back pain, compared to usual clinical care. Methods/Design A Cluster...

  2. 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

    OpenAIRE

    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

    2016-01-01

    Introduction 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. Methods and analysis This cluster ra...

  3. Therapist guided internet based cognitive behavioural therapy for body dysmorphic disorder: single blind randomised controlled trial

    OpenAIRE

    Enander, Jesper; Andersson, Erik; Mataix-Cols, David; Lichtenstein, Linn; Alstroem, Katarina; Andersson, Gerhard; Ljotsson, Brjann; Rueck, Christian

    2016-01-01

    Objectives To evaluate the efficacy of therapist guided internet based cognitive behavioural therapy (CBT) programme for body dysmorphic disorder (BDD-NET) compared with online supportive therapy. Design A 12 week single blind parallel group randomised controlled trial. Setting Academic medical centre. Participants 94 self referred adult outpatients with a diagnosis of body dysmorphic disorder and a modified Yale-Brown obsessive compulsive scale (BDD-YBOCS) score of ≥20. Concurrent psychotrop...

  4. Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial.

    LENUS (Irish Health Repository)

    Nichol, Alistair

    2015-02-08

    Traumatic brain injury is a leading cause of death and disability worldwide. Laboratory and clinical studies demonstrate a possible beneficial effect of erythropoietin in improving outcomes in the traumatic brain injury cohort. However, there are concerns regarding the association of erythropoietin and thrombosis in the critically ill. A large-scale, multi-centre, blinded, parallel-group, placebo-controlled, randomised trial is currently underway to address this hypothesis.

  5. Randomised controlled trial of corticosteroid regimens in endothelial corneal allograft rejection

    OpenAIRE

    Hudde, T; Minassian, D; Larkin, D

    1999-01-01

    AIM—To determine whether the addition of systemic corticosteroid to local intensive corticosteroid therapy of endothelial corneal allograft rejection improves outcome.
METHODS—A prospective randomised treatment trial was carried out at a tertiary referral centre. 36 consecutive corneal graft recipients, presenting with a first episode of endothelial graft rejection, received either (i) one intravenous pulse of methylprednisolone 500 mg in addition to local corticosteroid treatment, or (ii) lo...

  6. Clinician-centred interventions to increase vaginal birth after caesarean section (VBAC): a systematic review.

    LENUS (Irish Health Repository)

    Lundgren, Ingela

    2015-02-05

    BackgroundThe number of caesarean sections (CS) is increasing globally, and repeat CS after a previous CS is a significant contributor to the overall CS rate. Vaginal birth after caesarean (VBAC) can be seen as a real and viable option for most women with previous CS. To achieve success, however, women need the support of their clinicians (obstetricians and midwives). The aim of this study was to evaluate clinician-centred interventions designed to increase the rate of VBAC.MethodsThe bibliographic databases of The Cochrane Library, PubMed, PsychINFO and CINAHL were searched for randomised controlled trials, including cluster randomised trials that evaluated the effectiveness of any intervention targeted directly at clinicians aimed at increasing VBAC rates. Included studies were appraised independently by two reviewers. Data were extracted independently by three reviewers. The quality of the included studies was assessed using the quality assessment tool, `Effective Public Health Practice Project¿. The primary outcome measure was VBAC rates.Results238 citations were screened, 255 were excluded by title and abstract. 11 full-text papers were reviewed; eight were excluded, resulting in three included papers. One study evaluated the effectiveness of antepartum x-ray pelvimetry (XRP) in 306 women with one previous CS. One study evaluated the effects of external peer review on CS birth in 45 hospitals, and the third evaluated opinion leader education and audit and feedback in 16 hospitals. The use of external peer review, audit and feedback had no significant effect on VBAC rates. An educational strategy delivered by an opinion leader significantly increased VBAC rates. The use of XRP significantly increased CS rates.ConclusionsThis systematic review indicates that few studies have evaluated the effects of clinician-centred interventions on VBAC rates, and interventions are of varying types which limited the ability to meta-analyse data. A further limitation is that

  7. A designated centre for people with disabilities operated by Brothers of Charity Southern Services, Cork

    LENUS (Irish Health Repository)

    Lundgren, Ingela

    2015-02-05

    BackgroundThe number of caesarean sections (CS) is increasing globally, and repeat CS after a previous CS is a significant contributor to the overall CS rate. Vaginal birth after caesarean (VBAC) can be seen as a real and viable option for most women with previous CS. To achieve success, however, women need the support of their clinicians (obstetricians and midwives). The aim of this study was to evaluate clinician-centred interventions designed to increase the rate of VBAC.MethodsThe bibliographic databases of The Cochrane Library, PubMed, PsychINFO and CINAHL were searched for randomised controlled trials, including cluster randomised trials that evaluated the effectiveness of any intervention targeted directly at clinicians aimed at increasing VBAC rates. Included studies were appraised independently by two reviewers. Data were extracted independently by three reviewers. The quality of the included studies was assessed using the quality assessment tool, `Effective Public Health Practice Project¿. The primary outcome measure was VBAC rates.Results238 citations were screened, 255 were excluded by title and abstract. 11 full-text papers were reviewed; eight were excluded, resulting in three included papers. One study evaluated the effectiveness of antepartum x-ray pelvimetry (XRP) in 306 women with one previous CS. One study evaluated the effects of external peer review on CS birth in 45 hospitals, and the third evaluated opinion leader education and audit and feedback in 16 hospitals. The use of external peer review, audit and feedback had no significant effect on VBAC rates. An educational strategy delivered by an opinion leader significantly increased VBAC rates. The use of XRP significantly increased CS rates.ConclusionsThis systematic review indicates that few studies have evaluated the effects of clinician-centred interventions on VBAC rates, and interventions are of varying types which limited the ability to meta-analyse data. A further limitation is that

  8. A designated centre for people with disabilities operated by Brothers of Charity Services Ireland, Galway

    LENUS (Irish Health Repository)

    Murphy, Andrew W

    2005-07-29

    BACKGROUND: The aim of the SPHERE study is to design, implement and evaluate tailored practice and personal care plans to improve the process of care and objective clinical outcomes for patients with established coronary heart disease (CHD) in general practice across two different health systems on the island of Ireland. CHD is a common cause of death and a significant cause of morbidity in Ireland. Secondary prevention has been recommended as a key strategy for reducing levels of CHD mortality and general practice has been highlighted as an ideal setting for secondary prevention initiatives. Current indications suggest that there is considerable room for improvement in the provision of secondary prevention for patients with established heart disease on the island of Ireland. The review literature recommends structured programmes with continued support and follow-up of patients; the provision of training, tailored to practice needs of access to evidence of effectiveness of secondary prevention; structured recall programmes that also take account of individual practice needs; and patient-centred consultations accompanied by attention to disease management guidelines. METHODS: SPHERE is a cluster randomised controlled trial, with practice-level randomisation to intervention and control groups, recruiting 960 patients from 48 practices in three study centres (Belfast, Dublin and Galway). Primary outcomes are blood pressure, total cholesterol, physical and mental health status (SF-12) and hospital re-admissions. The intervention takes place over two years and data is collected at baseline, one-year and two-year follow-up. Data is obtained from medical charts, consultations with practitioners, and patient postal questionnaires. The SPHERE intervention involves the implementation of a structured systematic programme of care for patients with CHD attending general practice. It is a multi-faceted intervention that has been developed to respond to barriers and solutions to

  9. Insecticide-treated nets for the prevention of malaria in pregnancy: a systematic review of randomised controlled trials.

    Directory of Open Access Journals (Sweden)

    Carol Gamble

    2007-03-01

    Full Text Available BACKGROUND: Protection from malaria with insecticide-treated bednets (ITNs during pregnancy is widely advocated, but evidence of benefit has been inconsistent. We undertook a systematic review of randomised trials. METHODS AND FINDINGS: Three cluster-randomised and two individually randomised trials met the inclusion criteria; four from Africa (n = 6,418 and one from Thailand (n = 223. In Africa, ITNs compared to no nets increased mean birth weight by 55 g (95% confidence interval [CI] 21-88, reduced low birth weight by 23% (relative risk [RR] 0.77, 95% CI 0.61-0.98, and reduced miscarriages/stillbirths by 33% (RR 0.67, 0.47-0.97 in the first few pregnancies. Placental parasitaemia was reduced by 23% in all gravidae (RR 0.77, 0.66-0.90. The effects were apparent in the cluster-randomised trials and the one individually randomised trial in Africa. The trial in Thailand, which randomised individuals to ITNs or untreated nets, showed reductions in anaemia and fetal loss in all gravidae, but not reductions in clinical malaria or low birth weight. CONCLUSIONS: ITNs used throughout pregnancy or from mid-pregnancy onwards have a beneficial impact on pregnancy outcome in malaria-endemic Africa in the first few pregnancies. The potential impact of ITNs in pregnant women and their newborns in malaria regions outside Africa requires further research.

  10. Effects of PREPARE, a Multi-component, School-Based HIV and Intimate Partner Violence (IPV) Prevention Programme on Adolescent Sexual Risk Behaviour and IPV: Cluster Randomised Controlled Trial.

    Science.gov (United States)

    Mathews, Catherine; Eggers, Sander M; Townsend, Loraine; Aarø, Leif E; de Vries, Petrus J; Mason-Jones, Amanda J; De Koker, Petra; McClinton Appollis, Tracy; Mtshizana, Yolisa; Koech, Joy; Wubs, Annegreet; De Vries, Hein

    2016-09-01

    Young South Africans, especially women, are at high risk of HIV. We evaluated the effects of PREPARE, a multi-component, school-based HIV prevention intervention to delay sexual debut, increase condom use and decrease intimate partner violence (IPV) among young adolescents. We conducted a cluster RCT among Grade eights in 42 high schools. The intervention comprised education sessions, a school health service and a school sexual violence prevention programme. Participants completed questionnaires at baseline, 6 and 12 months. Regression was undertaken to provide ORs or coefficients adjusted for clustering. Of 6244 sampled adolescents, 55.3 % participated. At 12 months there were no differences between intervention and control arms in sexual risk behaviours. Participants in the intervention arm were less likely to report IPV victimisation (35.1 vs. 40.9 %; OR 0.77, 95 % CI 0.61-0.99; t(40) = 2.14) suggesting the intervention shaped intimate partnerships into safer ones, potentially lowering the risk for HIV. PMID:27142057

  11. Support and Assessment for Fall Emergency Referrals (SAFER 1 trial protocol. Computerised on-scene decision support for emergency ambulance staff to assess and plan care for older people who have fallen: evaluation of costs and benefits using a pragmatic cluster randomised trial

    Directory of Open Access Journals (Sweden)

    Roberts Stephen

    2010-01-01

    Full Text Available Abstract Background Many emergency ambulance calls are for older people who have fallen. As half of them are left at home, a community-based response may often be more appropriate than hospital attendance. The SAFER 1 trial will assess the costs and benefits of a new healthcare technology - hand-held computers with computerised clinical decision support (CCDS software - to help paramedics decide who needs hospital attendance, and who can be safely left at home with referral to community falls services. Methods/Design Pragmatic cluster randomised trial with a qualitative component. We shall allocate 72 paramedics ('clusters' at random between receiving the intervention and a control group delivering care as usual, of whom we expect 60 to complete the trial. Patients are eligible if they are aged 65 or older, live in the study area but not in residential care, and are attended by a study paramedic following an emergency call for a fall. Seven to 10 days after the index fall we shall offer patients the opportunity to opt out of further follow up. Continuing participants will receive questionnaires after one and 6 months, and we shall monitor their routine clinical data for 6 months. We shall interview 20 of these patients in depth. We shall conduct focus groups or semi-structured interviews with paramedics and other stakeholders. The primary outcome is the interval to the first subsequent reported fall (or death. We shall analyse this and other measures of outcome, process and cost by 'intention to treat'. We shall analyse qualitative data thematically. Discussion Since the SAFER 1 trial received funding in August 2006, implementation has come to terms with ambulance service reorganisation and a new national electronic patient record in England. In response to these hurdles the research team has adapted the research design, including aspects of the intervention, to meet the needs of the ambulance services. In conclusion this complex emergency care

  12. Support and Assessment for Fall Emergency Referrals (SAFER 1) trial protocol. Computerised on-scene decision support for emergency ambulance staff to assess and plan care for older people who have fallen: evaluation of costs and benefits using a pragmatic cluster randomised trial

    Science.gov (United States)

    2010-01-01

    Background Many emergency ambulance calls are for older people who have fallen. As half of them are left at home, a community-based response may often be more appropriate than hospital attendance. The SAFER 1 trial will assess the costs and benefits of a new healthcare technology - hand-held computers with computerised clinical decision support (CCDS) software - to help paramedics decide who needs hospital attendance, and who can be safely left at home with referral to community falls services. Methods/Design Pragmatic cluster randomised trial with a qualitative component. We shall allocate 72 paramedics ('clusters') at random between receiving the intervention and a control group delivering care as usual, of whom we expect 60 to complete the trial. Patients are eligible if they are aged 65 or older, live in the study area but not in residential care, and are attended by a study paramedic following an emergency call for a fall. Seven to 10 days after the index fall we shall offer patients the opportunity to opt out of further follow up. Continuing participants will receive questionnaires after one and 6 months, and we shall monitor their routine clinical data for 6 months. We shall interview 20 of these patients in depth. We shall conduct focus groups or semi-structured interviews with paramedics and other stakeholders. The primary outcome is the interval to the first subsequent reported fall (or death). We shall analyse this and other measures of outcome, process and cost by 'intention to treat'. We shall analyse qualitative data thematically. Discussion Since the SAFER 1 trial received funding in August 2006, implementation has come to terms with ambulance service reorganisation and a new national electronic patient record in England. In response to these hurdles the research team has adapted the research design, including aspects of the intervention, to meet the needs of the ambulance services. In conclusion this complex emergency care trial will provide

  13. The IGU Knowledge Centre

    NARCIS (Netherlands)

    Huizing, Bernardus

    2005-01-01

    This article describes an innovative service for members of the International Gas Union - IGU. The IGU Knowledge Centre provides members with relevant information and data. In this article is described why, how and where.

  14. CENTRE FOR GEOMETRICAL METROLOGY

    DEFF Research Database (Denmark)

    De Chiffre, Leonardo

    The objective of this Annual Report is to give a general introduction to CGM as well as to give an account of the tasks carried out using the facilities of CGM's Instrument Centre during 1998 and 1999....

  15. Virtual particle therapy centre

    CERN Multimedia

    2015-01-01

    Particle therapy is an advanced technique of cancer radiation therapy, using protons or other ions to target the cancerous mass. This advanced technique requires a multi-disciplinary team working in a specialised centre. 3D animation: Nymus3D

  16. The Bruce Energy Centre

    International Nuclear Information System (INIS)

    The Bruce Energy Centre Development Corporation is a joint venture of the Ontario Energy Corporation and 6 private companies formed to market surplus steam from the Bruce Nuclear Power Development. The corporation will also sell or lease land near Bruce NPD. The Bruce Energy Centre has an energy output of 900 BTU per day per dollar invested. Potential customers include greenhouse operators, aquaculturalists, food and beverage manufacturers, and traditional manufacturers

  17. Evaluation of the impact of a school gardening intervention on children’s fruit and vegetable intake: a randomised controlled trial

    OpenAIRE

    Christian, Meaghan S; Evans, Charlotte EL; Nykjaer, Camilla; Hancock, Neil; Cade, Janet E

    2014-01-01

    Background Current academic literature suggests that school gardening programmes can provide an interactive environment with the potential to change children’s fruit and vegetable intake. This is the first cluster randomised controlled trial (RCT) designed to evaluate whether a school gardening programme can have an effect on children’s fruit and vegetable intake. Methods The trial included children from 23 schools; these schools were randomised into two groups, one to receive the Royal Horti...

  18. Pre-Operative nutrition In Neck of femur Trial (POINT) - carbohydrate loading in patients with fragility hip fracture: study protocol for a randomised controlled trial

    OpenAIRE

    Moppett, Iain K; Greenhaff, Paul L; Ollivere, Ben J; Joachim, Theophillus; Lobo, Dileep N; Rowlands, Martin

    2014-01-01

    Background Trauma such as hip fracture initiates a neurohumoral stress response that changes the balance between anabolism and catabolism resulting in muscle breakdown and reduced mobilisation. Various studies have demonstrated a reduction in catabolism with pre-operative carbohydrate loading but only in an elective setting. Methods/Design This is a two-centre, randomised double-blinded trial in the United Kingdom. Sample size will be 30 patients (approximately 15 from each centre). Randomisa...

  19. Immune response to a new hepatitis B vaccine in healthcare workers who had not responded to standard vaccine: randomised double blind dose-response study.

    OpenAIRE

    Zuckerman, J N; Sabin, C.; Craig, F. M.; Williams, A.; Zuckerman, A J

    1997-01-01

    OBJECTIVE: To evaluate the immunogenicity and reactogenicity of a new triple S recombinant hepatitis B vaccine in a cohort of healthy people in whom currently licensed hepatitis B vaccines had persistently not induced an immune response. DESIGN: Single centre, randomised, double blind, dose-response study. SETTING: Research vaccine evaluation centre at a teaching hospital. SUBJECTS: 100 healthcare workers aged 18-70 years with a history of failure to seroconvert after at least four doses of a...

  20. Timing of intervention in high-risk non-ST-elevation acute coronary syndromes in PCI versus non-PCI centres

    OpenAIRE

    Badings, E. A.; Remkes, W. S.; Dambrink, J-H. E.; The, S. H. K.; Wijngaarden, J.; TJEERDSMA, G; Rasoul, S.; Timmer, J. R.; van der Wielen, M. L. J.; Lok, D.J.A.; van ’t Hof, A.W.J.

    2016-01-01

    Aims To compare the effect of timing of intervention in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) in percutaneous coronary intervention (PCI) versus non-PCI centres. Methods and results A post-hoc sub-analysis was performed of the ELISA III trial, a randomised multicentre trial investigating outcome of early ( 48 h) angiography and revascularisation in 542 patients with high-risk NSTE-ACS. 90 patients were randomised in non-PCI centres and tended to benefit more from a...

  1. The ideal Atomic Centre

    International Nuclear Information System (INIS)

    The author presents considerations which should prove to be of interest to all those who have to design, to construct and to operate a nuclear research centre. A large number of the ideas presented can also be applied to non-nuclear scientific research centres. In his report the author reviews: various problems with which the constructor is faced: ground-plan, infrastructure, buildings and the large units of scientific equipment in the centre, and those problems facing the director: maintenance, production, supplies, security. The author stresses the relationship which ought to exist between the research workers and the management. With this aim in view he proposes the creation of National School for Administration in Research which would train administrative executives for public or private organisations; they would be specialised in the fields of fundamental or applied research. (author)

  2. Renal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I) : a randomised clinical trial

    NARCIS (Netherlands)

    de Zeeuw, Dick; Anzalone, Deborah A.; Cain, Valerie A.; Cressman, Michael D.; Lambers Heerspink, Hiddo J.; Molitoris, Bruce A.; Monyak, John T.; Parving, Hans-Henrik; Remuzzi, Giuseppe; Sowers, James R.; Vidt, Donald G.

    2015-01-01

    Background The role of lipid-lowering treatments in renoprotection for patients with diabetes is debated. We studied the renal effects of two statins in patients with diabetes who had proteinuria. Methods PLANET I was a randomised, double-blind, parallel-group trial done in 147 research centres in A

  3. Development of de novo prolapse in untreated vaginal compartments after prolapse repair with and without mesh: a secondary analysis of a randomised controlled trial.

    NARCIS (Netherlands)

    Withagen, M.I.J.; Milani, A.L.; Leeuw, J.W. de; Vierhout, M.E.

    2012-01-01

    OBJECTIVE: To compare the de novo prolapse rate in the untreated vaginal compartments following conventional vaginal prolapse repair and tension-free vaginal mesh repair. DESIGN: Secondary analysis of a randomised controlled trial. SETTING: Thirteen centres in the Netherlands. POPULATION: Women with

  4. Lidar Calibration Centre

    Science.gov (United States)

    Pappalardo, Gelsomina; Freudenthaler, Volker; Nicolae, Doina; Mona, Lucia; Belegante, Livio; D'Amico, Giuseppe

    2016-06-01

    This paper presents the newly established Lidar Calibration Centre, a distributed infrastructure in Europe, whose goal is to offer services for complete characterization and calibration of lidars and ceilometers. Mobile reference lidars, laboratories for testing and characterization of optics and electronics, facilities for inspection and debugging of instruments, as well as for training in good practices are open to users from the scientific community, operational services and private sector. The Lidar Calibration Centre offers support for trans-national access through the EC HORIZON2020 project ACTRIS-2.

  5. International research centre launched

    International Nuclear Information System (INIS)

    Full text: The first scientific research and educational institution to be set up on a completely international basis was officially inaugurated in Trieste on 5 October 1964 by the Director General of IAEA, Dr. Sigvard Eklund, when he opened the first seminar of the International Centre for Theoretical Physics. As evidence of the international nature of the institution he noted that the scientists who would work and teach there during the first year represented sixteen different countries. By the end of 1964, the Centre building was nearing completion and three of the five floors were occupied. A successful symposium had been held on the subject of plasma physics, and a score of professors and fellows were at work, from Bulgaria, Czechoslovakia, Greece, India, Japan, Jordan, the Netherlands, Norway, Pakistan, Poland, the United Kingdom, and the United States. A dozen scientific papers had been issued as preprints. The main purpose of the Centre is to foster the advancement of theoretical physics through training and research; at first the chief subject will be high-energy and elementary particle physics. Plasma physics, low energy physics and solid-state physics will also be dealt with. Special attention is paid to the needs of the developing countries. Of the 25 fellows selected for the academic year 1964-65, more than half are from South America, Africa and Asia. In conjunction with the Research Centre, there is an Advanced School for theoretical Physics to provide graduate training for fellows who need such preparation before they embark upon research. The Centre works under the guidance of a Scientific Council comprising the president, Prof. M. Sandoval-Vallarta (Nuclear Energy Commission of Mexico); Prof. A. Abragam (Saclay, France); Prof. R. Oppenheimer (Institute for Advanced Study, Princeton, USA); Dr. V. Soloviev (Dubna, USSR); Prof V.F. Weiskopf (Director General, CERN) ; Prof Abdus Salam (Imperial College, London) ; Prof. P. Budini (University of Trieste

  6. Academic Drug Discovery Centres

    DEFF Research Database (Denmark)

    Kirkegaard, Henriette Schultz; Valentin, Finn

    2014-01-01

    Academic drug discovery centres (ADDCs) are seen as one of the solutions to fill the innovation gap in early drug discovery, which has proven challenging for previous organisational models. Prior studies of ADDCs have identified the need to analyse them from the angle of their economic...

  7. Implementing Responsibility Centre Budgeting

    Science.gov (United States)

    Vonasek, Joseph

    2011-01-01

    Recently, institutes of higher education (universities) have shown a renewed interest in organisational structures and operating methodologies that generate productivity and innovation; responsibility centre budgeting (RCB) is one such process. This paper describes the underlying principles constituting RCB, its origin and structural elements, and…

  8. ATLAS Visitors Centre

    CERN Multimedia

    claudia Marcelloni

    2009-01-01

    ATLAS Visitors Centre has opened its shiny new doors to the public. Officially launched on Monday February 23rd, 2009, the permanent exhibition at Point 1 was conceived as a tour resource for ATLAS guides, and as a way to preserve the public’s opportunity to get a close-up look at the experiment in action when the cavern is sealed.

  9. Limits of teacher delivered sex education: interim behavioural outcomes from randomised trial

    OpenAIRE

    Wight, Daniel; Raab, Gillian M.; Henderson, Marion; Abraham, Charles; Buston, Katie; Hart, Graham; Scott, Sue

    2002-01-01

    OBJECTIVE: To determine whether a theoretically based sex education programme for adolescents (SHARE) delivered by teachers reduced unsafe sexual intercourse compared with current practice. DESIGN: Cluster randomised trial with follow up two years after baseline (six months after intervention). A process evaluation investigated the delivery of sex education and broader features of each school. SETTING: Twenty five secondary schools in east Scotland. PARTICIPANTS: 8430 pupils aged 13-15 years;...

  10. A designated centre for people with disabilities operated by St John of God Community Services Limited, Kildare

    LENUS (Irish Health Repository)

    Murphy, Andrew W

    2005-07-29

    BACKGROUND: The aim of the SPHERE study is to design, implement and evaluate tailored practice and personal care plans to improve the process of care and objective clinical outcomes for patients with established coronary heart disease (CHD) in general practice across two different health systems on the island of Ireland. CHD is a common cause of death and a significant cause of morbidity in Ireland. Secondary prevention has been recommended as a key strategy for reducing levels of CHD mortality and general practice has been highlighted as an ideal setting for secondary prevention initiatives. Current indications suggest that there is considerable room for improvement in the provision of secondary prevention for patients with established heart disease on the island of Ireland. The review literature recommends structured programmes with continued support and follow-up of patients; the provision of training, tailored to practice needs of access to evidence of effectiveness of secondary prevention; structured recall programmes that also take account of individual practice needs; and patient-centred consultations accompanied by attention to disease management guidelines. METHODS: SPHERE is a cluster randomised controlled trial, with practice-level randomisation to intervention and control groups, recruiting 960 patients from 48 practices in three study centres (Belfast, Dublin and Galway). Primary outcomes are blood pressure, total cholesterol, physical and mental health status (SF-12) and hospital re-admissions. The intervention takes place over two years and data is collected at baseline, one-year and two-year follow-up. Data is obtained from medical charts, consultations with practitioners, and patient postal questionnaires. The SPHERE intervention involves the implementation of a structured systematic programme of care for patients with CHD attending general practice. It is a multi-faceted intervention that has been developed to respond to barriers and solutions to

  11. A randomised controlled trial of short term growth and collagen turnover in asthmatics treated with inhaled formoterol and budesonide

    OpenAIRE

    Heuck, C; Heickendorff, L; Wolthers, O

    2000-01-01

    AIMS—To determine effects on short term growth and collagen turnover of adding formoterol (Eformoterol) to half the glucocorticoid dose in children with asthma, treated with inhaled budesonide (Pulmicort Turbuhaler).
DESIGN—A randomised double blind, placebo controlled crossover study with two six-week periods.
SETTING—Outpatient clinic in secondary referral centre.
SUBJECTS—A total of 27 prepubertal children aged 6-13 years.
INTERVENTIONS—Formoterol 12 µg and dry powder ...

  12. Elderly Care Centre

    Science.gov (United States)

    Wagiman, Aliani; Haja Bava Mohidin, Hazrina; Ismail, Alice Sabrina

    2016-02-01

    The demand for elderly centre has increased tremendously abreast with the world demographic change as the number of senior citizens rose in the 21st century. This has become one of the most crucial problems of today's era. As the world progress into modernity, more and more people are occupied with daily work causing the senior citizens to lose the care that they actually need. This paper seeks to elucidate the best possible design of an elderly care centre with new approach in order to provide the best service for them by analysing their needs and suitable activities that could elevate their quality of life. All these findings will then be incorporated into design solutions so as to enhance the living environment for the elderly especially in Malaysian context.

  13. Strategies to improve retention in randomised trials

    OpenAIRE

    Brueton, V. C.; Tierney, J.; Stenning, S; Harding, S; Meredith, S.; Nazareth, I; Rait, G

    2013-01-01

    Background Loss to follow-up from randomised trials can introduce bias and reduce study power, affecting the generalisability, validity and reliability of results. Many strategies are used to reduce loss to follow-up and improve retention but few have been formally evaluated. Objectives To quantify the effect of strategies to improve retention on the proportion of participants retained in randomised trials and to investigate if the effect varied by trial strategy and trial setting. Search met...

  14. Randomised trial of biofeedback training for encopresis.

    OpenAIRE

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

    1996-01-01

    AIMS: To evaluate biofeedback training in children with encopresis and the effect on psychosocial function. DESIGN: Prospective controlled randomised study. PATIENT INTERVENTIONS: A multimodal treatment of six weeks. Children were randomised into two groups. Each group received dietary and toilet advice, enemas, oral laxatives, and anorectal manometry. One group also received five biofeedback training sessions. MAIN OUTCOME MEASURES: Successful treatment was defined as less than two episodes ...

  15. Tele-centres in Ghana

    DEFF Research Database (Denmark)

    Falch, Morten

    2004-01-01

    Tele-centres offer a low cost opportunity for the many who cannot afford their own phone or Internet connection. This paper presents a field study of tele-centres in Ghana and analyses how they contribute to universal access.......Tele-centres offer a low cost opportunity for the many who cannot afford their own phone or Internet connection. This paper presents a field study of tele-centres in Ghana and analyses how they contribute to universal access....

  16. Generation of allocation sequences in randomised trials: chance, not choice.

    Science.gov (United States)

    Schulz, Kenneth F; Grimes, David A

    2002-02-01

    The randomised controlled trial sets the gold standard of clinical research. However, randomisation persists as perhaps the least-understood aspect of a trial. Moreover, anything short of proper randomisation courts selection and confounding biases. Researchers should spurn all systematic, non-random methods of allocation. Trial participants should be assigned to comparison groups based on a random process. Simple (unrestricted) randomisation, analogous to repeated fair coin-tossing, is the most basic of sequence generation approaches. Furthermore, no other approach, irrespective of its complexity and sophistication, surpasses simple randomisation for prevention of bias. Investigators should, therefore, use this method more often than they do, and readers should expect and accept disparities in group sizes. Several other complicated restricted randomisation procedures limit the likelihood of undesirable sample size imbalances in the intervention groups. The most frequently used restricted sequence generation procedure is blocked randomisation. If this method is used, investigators should randomly vary the block sizes and use larger block sizes, particularly in an unblinded trial. Other restricted procedures, such as urn randomisation, combine beneficial attributes of simple and restricted randomisation by preserving most of the unpredictability while achieving some balance. The effectiveness of stratified randomisation depends on use of a restricted randomisation approach to balance the allocation sequences for each stratum. Generation of a proper randomisation sequence takes little time and effort but affords big rewards in scientific accuracy and credibility. Investigators should devote appropriate resources to the generation of properly randomised trials and reporting their methods clearly. PMID:11853818

  17. Randomised comparison of the effects of nicardipine and esmolol on coronary artery wall stress: implications for the risk of plaque rupture

    OpenAIRE

    Williams, M.; Low, C.; Wilkins, G; Stewart, R

    2000-01-01

    OBJECTIVE—To determine whether the β blocker esmolol reduces coronary artery wall stress more than the short acting dihydropyridine calcium antagonist nicardipine.
DESIGN—Randomised double blind placebo controlled trial.
SETTING—Tertiary cardiology centre.
PATIENTS—Patients with coronary artery disease.
INTERVENTIONS—20 patients were randomised double blind to an infusion of nicardipine (n = 10) or esmolol (n = 10) titrated to reduce systolic blood pressure by 20 mm Hg.
MAIN OUTCOME MEASURES—...

  18. Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: the LIMIT randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Crowther Caroline A

    2011-10-01

    Full Text Available Abstract Background Obesity is a significant global health problem, with the proportion of women entering pregnancy with a body mass index greater than or equal to 25 kg/m2 approaching 50%. Obesity during pregnancy is associated with a well-recognised increased risk of adverse health outcomes both for the woman and her infant, however there is more limited information available regarding effective interventions to improve health outcomes. The aims of this randomised controlled trial are to assess whether the implementation of a package of dietary and lifestyle advice to overweight and obese women during pregnancy to limit gestational weight gain is effective in improving maternal, fetal and infant health outcomes. Methods/Design Design: Multicentred randomised, controlled trial. Inclusion Criteria: Women with a singleton, live gestation between 10+0-20+0 weeks who are obese or overweight (defined as body mass index greater than or equal to 25 kg/m2, at the first antenatal visit. Trial Entry & Randomisation: Eligible, consenting women will be randomised between 10+0 and 20+0 weeks gestation using a central telephone randomisation service, and randomisation schedule prepared by non-clinical research staff with balanced variable blocks. Stratification will be according to maternal BMI at trial entry, parity, and centre where planned to give birth. Treatment Schedules: Women randomised to the Dietary and Lifestyle Advice Group will receive a series of inputs from research assistants and research dietician to limit gestational weight gain, and will include a combination of dietary, exercise and behavioural strategies. Women randomised to the Standard Care Group will continue to receive their pregnancy care according to local hospital guidelines, which does not currently include routine provision of dietary, lifestyle and behavioural advice. Outcome assessors will be blinded to the allocated treatment group. Primary Study Outcome: infant large for

  19. Psychosocial consequences in the Danish randomised controlled lung cancer screening trial (DLCST)

    DEFF Research Database (Denmark)

    F. Rasmussen, Jakob; Siersma, V.; H. Pedersen, J.;

    2015-01-01

    Objectives: To measure the psychosocial consequences in the Danish lung cancer screening trial (DLCST)and compare those between the computed tomography (CT) group and the control group. Materials and methods: This study was a single centre randomised controlled trial with five annual screening...... to complete the validated lung-cancer-specific questionnaire consequences of screening lung cancer (COS-LC). The CT group was also offered a low dose CT scan of the lungs. The COS-LC measures nine scales with psychosocial properties: Anxiety, Behaviour, Dejection, Negative impact on sleep, Self-blame, Focus...

  20. DGNB certified Healthcare Centres

    DEFF Research Database (Denmark)

    Brunsgaard, Camilla; Larsen, Tine Steen

    2015-01-01

    for sustainability and wants a certification. This research investigates the decision‐making and design process (DMaDP) behind four DGNB certified Healthcare Centres (HCC) in Northern Jutland in Denmark. In general, knowledge about the DMaDP is important. However it is important to know what part DGNB plays...... a dialog about DGNB and energy concept is important even before anyone start sketching. Experiences with the different approaches will be further outlined in the paper.Future research has the intention to collect further knowledge about DGNB and DMaDP in practise. This project was limited to Healthcare...

  1. Centre liikekeskuksen digital signage

    OpenAIRE

    Bincl, Suzana

    2015-01-01

    Opinnäytetyöni tarkastelee digital signagen suunnittelussa huomioitavia tekijöitä ja sen arvoa markkinointikanavana. Työ on toteutettu tilaustyönä Lappeenrantalaiselle mainostoimisto Mediakolmiolle. Työ sisältää teoriaosuuden lisäksi sisältösuunnitelman rakenteilla olevalle Centre liikekeskukselle. Tavoitteena oli luoda liikekeskukselle sen brändiä tukeva digital signage konsepti. Työ ei sisällä valmista tuotetta, vaan se toimii ehdotelmana myöhemmin alkavalle tuotanno...

  2. Town Centre Redevelopment Strategies

    DEFF Research Database (Denmark)

    Vagnby, Bo Hellisen

    urban planning and design strategieswhich have been practised in most of the larger Danish towns: pedestrian streets, shopping centres, preservation of historic features, waterfronts, concentration of offices, conference and sports facilities, improvement og traffic and transport conditions as well...... as slum clearence and urban renewal. To a certain extent parallels are drawn to international experiences, especially where these are of such a nature that they can be assumed transferred to Danish connctions. Conclusively, the strategies are discussed in the light of the turn of Danish urban planning...

  3. Patch: platelet transfusion in cerebral haemorrhage: study protocol for a multicentre, randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    Dijkgraaf Marcel G

    2010-03-01

    Full Text Available Abstract Background Patients suffering from intracerebral haemorrhage have a poor prognosis, especially if they are using antiplatelet therapy. Currently, no effective acute treatment option for intracerebral haemorrhage exists. Limiting the early growth of intracerebral haemorrhage volume which continues the first hours after admission seems a promising strategy. Because intracerebral haemorrhage patients who are on antiplatelet therapy have been shown to be particularly at risk of early haematoma growth, platelet transfusion may have a beneficial effect. Methods/Design The primary objective is to investigate whether platelet transfusion improves outcome in intracerebral haemorrhage patients who are on antiplatelet treatment. The PATCH study is a prospective, randomised, multi-centre study with open treatment and blind endpoint evaluation. Patients will be randomised to receive platelet transfusion within six hours or standard care. The primary endpoint is functional health after three months. The main secondary endpoints are safety of platelet transfusion and the occurrence of haematoma growth. To detect an absolute poor outcome reduction of 20%, a total of 190 patients will be included. Discussion To our knowledge this is the first randomised controlled trial of platelet transfusion for an acute haemorrhagic disease. Trial registration The Netherlands National Trial Register (NTR1303

  4. [The primary healthcare centres].

    Science.gov (United States)

    Brambilla, Antonio; Maciocco, Gavino

    2014-04-01

    The central attributes of primary care are: first contact (accessibility), longitudinality (person- focused preventive and curative care overtime), patient-oriented comprehensiveness and coordination (including navigation towards secondary and tertiary care). Besides taking care of the needs of the individuals, primary health care teams are also looking at the community, especially when addressing social determinants of health. The rationale for the benefits for primary care for health has been found in: 1) greater access to needed services; 2) better quality of care; 3) a greater focus on prevention; 4) early management of health problems; 5) organizing and delivering high quality care for chronic non-communicable diseases. This paper describes the role of primary healthcare centres in strengthening community primary services and in reducing health inequalities. Furthemore, the experiences of Regional Health Services from Tuscany and Emilia-Romagna are discussed, with a brief overview of the literature. PMID:24770539

  5. Experiences of Telebased Information Centres

    DEFF Research Database (Denmark)

    Falch, Morten

    1999-01-01

    Tele-based information community centres or just tele-centres have been seen as the killer application to empower local communities in developed and developing countries to meet the challenges of the information society. This paper will present a number of models for introducing such centres and ...... and discuss the different models and national strategies used for setting up tele-based information in relation to the Ghana experience.......Tele-based information community centres or just tele-centres have been seen as the killer application to empower local communities in developed and developing countries to meet the challenges of the information society. This paper will present a number of models for introducing such centres...

  6. Update on System Coordination Centre

    Energy Technology Data Exchange (ETDEWEB)

    Stangl, W. [Power Pool of Alberta, Calgary, AB (Canada)

    1998-07-01

    The new System Coordination Centre at the Power Pool of Alberta was designed to meet the unique requirements of Alberta`s electric industry under the new regulatory regime. Development of the Centre, key provisions of the energy management system (EMS) are highlighted. The centre will provide an energy management system for the Pool`s system controller function and interface with the Power Pool Administrator`s market functions and the operations of the Transmission Administrator. System controllers are expected to be operating from the new location by the end of 1998. Unique EMS features of the centre include: (1) real-time management of energy market and network operations using diverse SCADA/EMS, (2) inter-control centre protocol used to accommodate the unique participant information requirements, and (3) special custom applications. The Centre is expected to be fully functioning by July 1999. 1 fig.

  7. A randomised controlled trial on the efficacy and tolerability with dose escalation of allopurinol 300-600 mg/day versus benzbromarone 100-200 mg/day in patients with gout

    NARCIS (Netherlands)

    Reinders, M. K.; Haagsma, C.; Jansen, T. L. Th A.; van Roon, E. N.; Delsing, J.; de Laar, M. A. F. J. van; Brouwers, J. R. B. J.

    2009-01-01

    Objectives: To compare the efficacy and tolerability of allopurinol 300-600 mg/day versus benzbromarone 100-200 mg/day used to attain a target serum urate concentration (sUr) (0.30 mmol/l (5 mg/dl). Methods: A randomised, controlled, open-label, multi-centre trial in gout patients with renal functio

  8. Management of cluster headache.

    Science.gov (United States)

    Tfelt-Hansen, Peer C; Jensen, Rigmor H

    2012-07-01

    . For most cluster headache patients there are fairly good treatment options both for acute attacks and for prophylaxis. The big problem is the diagnosis of cluster headache as demonstrated by the diagnostic delay of 7 years. However, the relatively short-lasting attack of pain in one eye with typical associated symptoms should lead the family doctor to suspect cluster headache resulting in a referral to a neurologist or a headache centre with experience in the treatment of cluster headache. PMID:22650381

  9. Council celebrates CERN Control Centre

    CERN Multimedia

    2006-01-01

    With the unveiling of its new sign, the CERN Control Centre was officially inaugurated on Thursday 16 March. To celebrate its startup, CERN Council members visited the sleek centre, a futuristic-looking room filled with a multitude of monitoring screens.

  10. The OPERA trial: protocol for a randomised trial of an exercise intervention for older people in residential and nursing accommodation

    Directory of Open Access Journals (Sweden)

    Taylor Stephanie

    2011-02-01

    Full Text Available Abstract Background Depression is common in residents of Residential and Nursing homes (RNHs. It is usually undetected and often undertreated. Depression is associated with poor outcomes including increased morbidity and mortality. Exercise has potential to improve depression, and has been shown in existing trials to improve outcomes among younger and older people. Existing evidence comes from trials that are short, underpowered and not from RNH settings. The aim of the OPERA trial is to establish whether exercise is effective in reducing the prevalence of depression among older RNH residents. Method OPERA is a cluster randomised controlled trial. RNHs are randomised to one of two groups with interventions lasting 12 months Intervention group: a depression awareness and physical activity training session for care home staff, plus a whole home physical activation programme including twice weekly physiotherapist-led exercise groups. The intervention lasts for one year from randomisation, or Control group: a depression awareness training session for care home staff. Participants are people aged 65 or over who are free of severe cognitive impairment and willing to participate in the study. Our primary outcome is the prevalence of depressive symptoms, a GDS-15 score of five or more, in all participants at the end of the one year intervention period. Our secondary depression outcomes include remission of depressive symptoms and change in GDS-15 scores in those with depressive symptoms prior to randomisation. Other secondary outcomes include, fear of falling, mobility, fractures, pain, cognition, costs and health related quality of life. We aimed to randomise 77 RNHs. Discussion Home recruitment was completed in May 2010; 78 homes have been randomised. Follow up will finish in May 2011 and results will be available late 2011. Trial Registration [ISRCTN: ISRCTN43769277

  11. Effects on musculoskeletal pain, work ability and sickness absence in a 1-year randomised controlled trial among cleaners

    OpenAIRE

    Jørgensen Marie B; Faber Anne; Hansen Jørgen V; Holtermann Andreas; Søgaard Karen

    2011-01-01

    Abstract Background Only a few workplace initiatives among cleaners have been reported, even though they constitute a job group in great need of health promotion. The purpose of this trial was to evaluate the effect of either physical coordination training or cognitive behavioural training on musculoskeletal pain, work ability and sickness absence among cleaners. Methods A cluster-randomised controlled trial was conducted among 294 female cleaners allocated to either physical coordination tra...

  12. Variational treatment of the centre-of-mass motion

    Energy Technology Data Exchange (ETDEWEB)

    Bouten, M.; Cornelissens, T. (Limburgs Universitair Centrum (Belgium)); Bouten, M.C. (Centre d' Etude de l' Energie Nucleaire, Mol (Belgium))

    1985-02-01

    The weight function in the general expression of Lipkin (1958 Phys. Rev. 110,1395) for eliminating the centre-of-mass coordinate from nuclear wave functions has been approximated by a gaussian function exp(-lambdaR/sup 2/) with on parameter, lambda, to be determined by a variational calculation. This calculation has been carried out for the ground state of /sup 6/Li and the lowest energy has been obtained for a negative value of lambda. An explanation for this surprising result based on the cluster model is given. The result is also compared with other proposals in the literature for treating the centre-of-mass motion in nuclei.

  13. Preliminary ten year results from a randomised single centre mass screening trial for abdominal aortic aneurysm

    DEFF Research Database (Denmark)

    Lindholt, Jes S.; Juul, Svend; Fasting, Helge;

    2006-01-01

    BACKGROUND: At present, several regions and countries are considering screening for abdominal aortic aneurysm (AAA). However, The Chichester Aneurysms Screening Trial has reported poor long term benefit of screening for AAA. We therefore supplement previously published data with a preliminary......,333 were invited to an abdominal ultrasound scan at their district hospital. Information on all deaths until 15.3.2005 was obtained from the Office of Civil Registration. Information on AAA related deaths was obtained from the national registry of Causes of Deaths from 1.4.1994 to 31...

  14. Acupuncture for persistent allergic rhinitis: a multi-centre, randomised, controlled trial protocol

    OpenAIRE

    Kang Kyung-Won; Shin Mi-Suk; Kim Ae-Ran; Zhao Jiping; Zhao Hong; Ko Jeong-Min; Lee Sanghoon; Choi Jun-Yong; Jung So-Young; Lee Myeong Soo; Kim Jong-In; Jung Hee-Jung; Kim Tae-Hun; Liu Baoyan; Choi Sun-Mi

    2009-01-01

    Abstract Background Allergic rhinitis is one of the most common health complaints worldwide. Complementary and alternative medical approaches have been employed to relieve allergic rhinitis symptoms and to avoid the side effects of conventional medication. Acupuncture has been widely used to treat patients with allergic rhinitis, but the available evidence of its effectiveness is insufficient. Our objective is to evaluate the effectiveness of acupuncture in patients in Korea and China with pe...

  15. Phase 2, randomised placebo-controlled trial to evaluate the efficacy and safety of an anti-GM-CSF antibody (KB003) in patients with inadequately controlled asthma

    OpenAIRE

    Molfino, Nestor A; Kuna, Piotr; Leff, Jonathan A; Oh, Chad K; Singh, Dave; Chernow, Marlene; Sutton, Brian; Yarranton, Geoffrey

    2016-01-01

    Objectives We wished to evaluate the effects of an antigranulocyte-macrophage colony-stimulating factor monoclonal antibody (KB003) on forced expiratory volume in 1 s (FEV1), asthma control and asthma exacerbations in adult asthmatics inadequately controlled by long-acting bronchodilators and inhaled/oral corticosteroids. Settings 47 ambulatory asthma care centres globally. Primary outcome measures Change in FEV1 at week 24. Participants 311 were screened, 160 were randomised and 129 complete...

  16. The Magpie Trial: a randomised trial comparing magnesium sulphate with placebo for pre-eclampsia. Outcome for children at 18 months

    OpenAIRE

    ,

    2006-01-01

    Objective To assess the long-term effects of in utero exposure to magnesium sulphate for children whose mothers had pre-eclampsia. Design Assessment at 18 months of age for children whose mothers were recruited to the Magpie Trial (recruitment 1998–2001 ISRCTN 86938761), which compared magnesium sulphate with placebo. Setting Follow-up of children born at 125 centres in 19 countries across five continents. Population A total of 6922 children were born to women randomised before delivery at fo...

  17. Does single application of topical chloramphenicol to high risk sutured wounds reduce incidence of wound infection after minor surgery? Prospective randomised placebo controlled double blind trial

    OpenAIRE

    Heal, Clare F; Petra G Buettner; Cruickshank, Robert; Graham, David; Browning, Sheldon; Pendergast, Jayne; Drobetz, Herwig; Gluer, Robert; Lisec, Carl

    2009-01-01

    Objective To determine the effectiveness of a single application of topical chloramphenicol ointment in preventing wound infection after minor dermatological surgery. Design Prospective randomised placebo controlled double blind multicentre trial. Setting Primary care in a regional centre in Queensland, Australia. Participants 972 minor surgery patients. Interventions A single topical dose of chloramphenicol (n=488) or paraffin ointment (n=484; placebo). Main outcome measure Incidence of infe...

  18. A randomised, waiting list controlled trial of cognitive behavioural therapy for persistent postconcussional symptoms after predominantly mild-moderate traumatic brain injury

    OpenAIRE

    Potter, Sebastian; Brown, Richard Gerard; Fleminger, Simon

    2016-01-01

    Persistent post-concussional symptoms (PCS) can be a source of distress and disability following traumatic brain (TBI). Such symptoms have been viewed as difficult to treat but may be amenable topsychological approaches such as cognitive behaviour therapy (CBT). ObjectivesTo evaluate the effectiveness of a 12-session individualised, formulation-based CBT program.MethodTwo-centre randomised waiting list controlled trial with 46 adults with persistent PCS after predominantly mild-to-moderate TB...

  19. No relevant cardiac, pharmacokinetic or safety interactions between roflumilast and inhaled formoterol in healthy subjects: an open-label, randomised, actively controlled study

    OpenAIRE

    de Mey, Christian; Nassr, Nassr; Lahu, Gezim

    2011-01-01

    Background Roflumilast is an oral, selective phosphodiesterase 4 inhibitor with anti-inflammatory effects in chronic obstructive pulmonary disease (COPD). The addition of roflumilast to long-acting bronchodilators improves lung function in patients with moderate-to-severe COPD. The present study investigated drug-drug interaction effects between inhaled formoterol and oral roflumilast. Methods This was a single-centre (investigational clinic), open, randomised, multiple-dose, parallel-group s...

  20. Characterisation of microcalcification clusters on 2D digital mammography (FFDM) and digital breast tomosynthesis (DBT): does DBT underestimate microcalcification clusters? Results of a multicentre study

    Energy Technology Data Exchange (ETDEWEB)

    Tagliafico, Alberto [University of Genoa, Institute of Anatomy, Department of Experimental Medicine (DIMES), Genoa (Italy); Mariscotti, Giovanna; Durando, Manuela [Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino, Radiology University of Torino, Department of Diagnostic Imaging and Radiotherapy, Torino (Italy); Stevanin, Carmen [Ospedale Regionale di Bolzano, Bolzano (Italy); Tagliafico, Giulio [Istituto di Matematica Applicata e Tecnologie Informatiche, CNR-IMATI, Consiglio Nazionale delle Ricerche, Genova (Italy); Martino, Lucia; Bignotti, Bianca [University of Genoa, Department of Health Sciences (DISSAL), Genoa (Italy); Calabrese, Massimo [IRCCS AOU San Martino-IST, Department of Breast Radiology, Genova (Italy); Houssami, Nehmat [University of Sydney, Screening and Test Evaluation Program (STEP), School of Public Health, Sydney Medical School, Sydney (Australia)

    2015-01-15

    To compare DBT and FFDM in the classification of microcalcification clusters (MCs) using BI-RADS. This Institutional Review Board-approved study was undertaken in three centres. A total of 107 MCs evaluated with both DBT and FFDM were randomised for prospective reading by six experienced breast radiologists and classified using BI-RADS. The benign/malignant ratio of MC was 66/41. Of 11/107 discordant results, DBT classified MCs as R2 whereas FFDM classified them as R3 in 9 and R4 in 2. Three of these (3/107 = 2.8 %) were malignant; 8 (7.5 %) were nonmalignant and were correctly classified as R2 on DBT but incorrectly classified as R3 on FFDM. Estimated sensitivity and specificity, respectively, were 100 % (95 % CI: 91 % to 100 %) and 94.6 % (95 % CI: 86.7 % to 98.5 %) for FFDM and 91.1 % (95 % CI: 78.8 % to 97.5 %) and 100 % (95 % CI: 94.8 % to 100 %) for DBT. Overall intra- and interobserver agreements were 0.75 (95 % CI: 0.61-0.84) and 0.73 (95 % CI: 0.62-0.78). Most MCs are scored similarly on FFDM and DBT. Although a minority (11/107) of MCs are classified differently on FFDM (benign MC classified as R3) and DBT (malignant MC classified as R2), this may have clinical relevance. (orig.)

  1. The Aube centre; Le Centre de l`Aube

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-07-01

    This educational booklet is devoted to a general presentation of the Aube radioactive wastes storage centre. After a short presentation of the Andra, the French national agency for the management of radioactive wastes, it gives some general information about radioactive wastes (origin, classification), containers (quality assurance and different types), wastes transportation (planning, safety), and about the Aube centre itself: description, treatment and conditioning of drums (compacting and injection), storage facilities, geological situation of the site, and environmental controls. (J.S.)

  2. Galaxy cluster's rotation

    CERN Document Server

    Manolopoulou, Maria

    2016-01-01

    We study the possible rotation of cluster galaxies, developing, testing and applying a novel algorithm which identifies rotation, if such does exits, as well as its rotational centre, its axis orientation, rotational velocity amplitude and, finally, the clockwise or counterclockwise direction of rotation on the plane of the sky. To validate our algorithms we construct realistic Monte-Carlo mock rotating clusters and confirm that our method provides robust indications of rotation. We then apply our methodology on a sample of Abell clusters with z<~0.1 with member galaxies selected from the SDSS DR10 spectroscopic database. We find that ~35% of our clusters are rotating when using a set of strict criteria, while loosening the criteria we find this fraction increasing to ~48%. We correlate our rotation indicators with the cluster dynamical state, provided either by their Bautz-Morgan type or by their X-ray isophotal shape and find for those clusters showing rotation that the significance and strength of their...

  3. Contemporary design for 'landmark' centre.

    Science.gov (United States)

    2009-08-01

    As one of the UK's largest builders of healthcare facilities, construction company Morgan Ashurst is accustomed to delivering complex, challenging hospital projects. The construction of a new oncology centre at Musgrove Park Hospital, Taunton for Taunton and Somerset NHS Foundation Trust-- said to be the first new stand-alone radiotherapy centre to be built in the UK for almost 20 years--was no exception. Health Estate Journal reports. PMID:19711668

  4. The centre of the action

    CERN Document Server

    2008-01-01

    The CERN Control Centre (CCC) has all the ingredients of an action movie control room: hundreds of screens, technicians buzzing in and out, huge floor-to-ceiling windows revealing the looming vista of a mountain range, flashing lights, microphones… This is the place where not just the LHC, but the whole of CERN’s accelerator complex and technical support is based - truly the centre of the action at CERN.

  5. On the Particles Transport Between Embedded Clusters

    OpenAIRE

    Despa, F.; Topa, V.

    1996-01-01

    Diffusional interactions within the Ostwald Ripening process are analyzed in the present paper. An {\\it off-centre diffusion approach \\/} is performed to point out the direct correlation between the size of clusters. Herein the diffusion solution is derived as a function of both the growing and shrinking cluster sizes. Also, it is shown that the frequency transfer of particles between the shrinking cluster and the growing one may acquire high values due to the medium polarization. As a result...

  6. Training centres - organization and management

    International Nuclear Information System (INIS)

    In the lecture 'Training centres - organization and management' some principles and requirements which influence the organization, management and activity pattern of nuclear training centres, are briefly introduced. It is demonstrated, step by step, how these general principles are implemented in the development of the Czechoslovak nuclear power programme, it means, how the training of the NPP personnel proceeds in Czechoslovak nuclear training centres. General principles which are selected: a connection between the capacity of the training centre and the scope and needs of the nuclear power programme, a position of the training center within the institutional set-up, a structure and organization of the training system which complies with the system of NPP construction, reflect the pattern and the activity of the nuclear training centre and nuclear power technical level, a research group of workers in the nuclear training centre, main tasks and technical facilities, management of the training process and a transfer of knowledge and research results into the training process. The lecture is supplemented by pictures and slides. (orig.)

  7. The SPHERE Study. Secondary prevention of heart disease in general practice: protocol of a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses. [ISRCTN24081411].

    LENUS (Irish Health Repository)

    Murphy, Andrew W

    2005-07-29

    BACKGROUND: The aim of the SPHERE study is to design, implement and evaluate tailored practice and personal care plans to improve the process of care and objective clinical outcomes for patients with established coronary heart disease (CHD) in general practice across two different health systems on the island of Ireland. CHD is a common cause of death and a significant cause of morbidity in Ireland. Secondary prevention has been recommended as a key strategy for reducing levels of CHD mortality and general practice has been highlighted as an ideal setting for secondary prevention initiatives. Current indications suggest that there is considerable room for improvement in the provision of secondary prevention for patients with established heart disease on the island of Ireland. The review literature recommends structured programmes with continued support and follow-up of patients; the provision of training, tailored to practice needs of access to evidence of effectiveness of secondary prevention; structured recall programmes that also take account of individual practice needs; and patient-centred consultations accompanied by attention to disease management guidelines. METHODS: SPHERE is a cluster randomised controlled trial, with practice-level randomisation to intervention and control groups, recruiting 960 patients from 48 practices in three study centres (Belfast, Dublin and Galway). Primary outcomes are blood pressure, total cholesterol, physical and mental health status (SF-12) and hospital re-admissions. The intervention takes place over two years and data is collected at baseline, one-year and two-year follow-up. Data is obtained from medical charts, consultations with practitioners, and patient postal questionnaires. The SPHERE intervention involves the implementation of a structured systematic programme of care for patients with CHD attending general practice. It is a multi-faceted intervention that has been developed to respond to barriers and solutions to

  8. IntroductionThe Cluster mission

    Directory of Open Access Journals (Sweden)

    M. Fehringer

    Full Text Available The Cluster mission, ESA’s first cornerstone project, together with the SOHO mission, dating back to the first proposals in 1982, was finally launched in the summer of 2000. On 16 July and 9 August, respectively, two Russian Soyuz rockets blasted off from the Russian cosmodrome in Baikonour to deliver two Cluster spacecraft, each into their proper orbit. By the end of August 2000, the four Cluster satellites had reached their final tetrahedral constellation. The commissioning of 44 instruments, both individually and as an ensemble of complementary tools, was completed five months later to ensure the optimal use of their combined observational potential. On 1 February 2001, the mission was declared operational. The main goal of the Cluster mission is to study the small-scale plasma structures in three dimensions in key plasma regions, such as the solar wind, bow shock, magnetopause, polar cusps, magnetotail and the auroral zones. With its unique capabilities of three-dimensional spatial resolution, Cluster plays a major role in the International Solar Terrestrial Program (ISTP, where Cluster and the Solar and Heliospheric Observatory (SOHO are the European contributions. Cluster’s payload consists of state-of-the-art plasma instrumentation to measure electric and magnetic fields from the quasi-static up to high frequencies, and electron and ion distribution functions from energies of nearly 0 eV to a few MeV. The science operations are coordinated by the Joint Science Operations Centre (JSOC, at the Rutherford Appleton Laboratory (UK, and implemented by the European Space Operations Centre (ESOC, in Darmstadt, Germany. A network of eight national data centres has been set up for raw data processing, for the production of physical parameters, and their distribution to end users all over the world. The latest information on the Cluster mission can be found at http://sci.esa.int/cluster/.

  9. Randomised controlled trials: important but overrated?

    LENUS (Irish Health Repository)

    Boylan, J F

    2012-02-01

    Practising physicians individualise treatments, hoping to achieve optimal outcomes by tackling relevant patient variables. The randomised controlled trial (RCT) is universally accepted as the best means of comparison. Yet doctors sometimes wonder if particular patients might benefit more from treatments that fared worse in the RCT comparisons. Such clinicians may even feel ostracised by their peers for stepping outside treatments based on RCTs and guidelines. Are RCTs the only acceptable evaluations of how patient care can be assessed and delivered? In this controversy we explore the interpretation of RCT data for practising clinicians facing individualised patient choices. First, critical care anaesthetists John Boylan and Brian Kavanagh emphasise the dangers of bias and show how Bayesian approaches utilise prior probabilities to improve posterior (combined) probability estimates. Secondly, Jane Armitage, of the Clinical Trial Service Unit in Oxford, argues why RCTs remain essential and explores how the quality of randomisation can be improved through systematic reviews and by avoiding selective reporting.

  10. User centred evaluation of a recommendation based image browsing system

    OpenAIRE

    Leelanupab, T.; Hopfgartner, F.; Jose, J.M.

    2009-01-01

    In this paper, we introduce a novel approach to recommend images by mining user interactions based on implicit feedback of user browsing. The underlying hypothesis is that the interaction implicitly indicates the interests of the users for meeting practical image retrieval tasks. The algorithm mines interaction data and also low-level content of the clicked images to choose diverse images by clustering heterogeneous features. A user-centred, task-oriented, comparative evaluation was undertake...

  11. Reducing errors in health care: cost-effectiveness of multidisciplinary team training in obstetric emergencies (TOSTI study; a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Mol Ben

    2010-10-01

    Full Text Available Abstract Background There are many avoidable deaths in hospitals because the care team is not well attuned. Training in emergency situations is generally followed on an individual basis. In practice, however, hospital patients are treated by a team composed of various disciplines. To prevent communication errors, it is important to focus the training on the team as a whole, rather than on the individual. Team training appears to be important in contributing toward preventing these errors. Obstetrics lends itself to multidisciplinary team training. It is a field in which nurses, midwives, obstetricians and paediatricians work together and where decisions must be made and actions must be carried out under extreme time pressure. It is attractive to belief that multidisciplinary team training will reduce the number of errors in obstetrics. The other side of the medal is that many hospitals are buying expensive patient simulators without proper evaluation of the training method. In the Netherlands many hospitals have 1,000 or less annual deliveries. In our small country it might therefore be more cost-effective to train obstetric teams in medical simulation centres with well trained personnel, high fidelity patient simulators, and well defined training programmes. Methods/design The aim of the present study is to evaluate the cost-effectiveness of multidisciplinary team training in a medical simulation centre in the Netherlands to reduce the number of medical errors in obstetric emergency situations. We plan a multicentre randomised study with the centre as unit of analysis. Obstetric departments will be randomly assigned to receive multidisciplinary team training in a medical simulation centre or to a control arm without any team training. The composite measure of poor perinatal and maternal outcome in the non training group was thought to be 15%, on the basis of data obtained from the National Dutch Perinatal Registry and the guidelines of the

  12. A randomised comparison of cognitive behavioural therapy

    OpenAIRE

    De Roos, Carlijn; Greenwald, Ricky; Hollander-Gijsman, Margien den; Noorthoorn, Eric; van Buuren, Stef; Jongh, Ad De

    2011-01-01

    Background: Building on previous research with disaster-exposed children and adolescents, a randomised clinical trial was performed in the treatment of trauma-related symptoms. In the current study two active treatments were compared among children in a broad age range and from a wide diversity of ethnic populations. Objective: The primary aim was to compare the effectiveness and efficiency of Cognitive Behavioural Therapy (CBT) and Eye Movement Desensitisation and Reprocessing (EMDR). Design...

  13. Weighted Clustering

    DEFF Research Database (Denmark)

    Ackerman, Margareta; Ben-David, Shai; Branzei, Simina;

    2012-01-01

    We investigate a natural generalization of the classical clustering problem, considering clustering tasks in which different instances may have different weights.We conduct the first extensive theoretical analysis on the influence of weighted data on standard clustering algorithms in both the...... partitional and hierarchical settings, characterizing the conditions under which algorithms react to weights. Extending a recent framework for clustering algorithm selection, we propose intuitive properties that would allow users to choose between clustering algorithms in the weighted setting and classify...

  14. Cervical occlusion in women with cervical insufficiency: protocol for a randomised, controlled trial with cerclage, with and without cervical occlusion

    DEFF Research Database (Denmark)

    Secher, Niels Jørgen; MaCormack, CD; Weber, Tom;

    2007-01-01

    OBJECTIVE: To evaluate the effect of double cerclage compared with a single cerclage. DESIGN: Randomised, controlled multicentre trial. SETTING: Ten different countries are participating with both secondary and tertiary centres. The countries participating are Denmark, Sweden, Germany, United...... their external os closed with a continuous nylon 2-0/3-0 suture, in addition to the standard single cerclage. Local guidelines concerning antibiotics, Heparin, bed rest, tocolytics etc. are followed and recorded in the follow-up form. MAIN OUTCOME MEASURES: Primary endpoint is take home baby rate. The secondary...

  15. The ideal Atomic Centre; Le Centre Atomique ideal

    Energy Technology Data Exchange (ETDEWEB)

    Mas, R. [Commissariat a l' Energie Atomique, Saclay (France). Centre d' Etudes Nucleaires

    1965-07-01

    The author presents considerations which should prove to be of interest to all those who have to design, to construct and to operate a nuclear research centre. A large number of the ideas presented can also be applied to non-nuclear scientific research centres. In his report the author reviews: various problems with which the constructor is faced: ground-plan, infrastructure, buildings and the large units of scientific equipment in the centre, and those problems facing the director: maintenance, production, supplies, security. The author stresses the relationship which ought to exist between the research workers and the management. With this aim in view he proposes the creation of National School for Administration in Research which would train administrative executives for public or private organisations; they would be specialised in the fields of fundamental or applied research. (author) [French] L'auteur propose une base de reflexions a tous ceux qui doivent concevoir, realiser et faire vivre un Centre d'Etudes Nucleaires. Un grand nombre des idees exprimees peut d'ailleurs s'appliquer a un Centre d'Etudes Scientifiques non nucleaires. Dans son ouvrage, l'auteur passe en revue les differents problemes qui se posent au constructeur: plan, masse, infrastructure, batiments et grands appareils du Centre, et ceux qu'a a resoudre le directeur: entretien, fabrication, approvisionnements, securite. L'auteur insiste sur l'aspect des rapports qui doivent exister entre les chercheurs et ceux qui les administrent. Il propose a cette fin la creation d'une Ecole Nationale d'Administration de la Recherche qui formerait des cadres administratifs pour les organismes publics ou prives, specialises dans la Recherche fondamentale ou appliquee. (auteur)

  16. The influence of socioeconomic environment on the effectiveness of alcohol prevention among European students: a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Faggiano Fabrizio

    2011-05-01

    Full Text Available Abstract Background Although social environments may influence alcohol-related behaviours in youth, the relationship between neighbourhood socioeconomic context and effectiveness of school-based prevention against underage drinking has been insufficiently investigated. We study whether the social environment affects the impact of a new school-based prevention programme on alcohol use among European students. Methods During the school year 2004-2005, 7079 students 12-14 years of age from 143 schools in nine European centres participated in this cluster randomised controlled trial. Schools were randomly assigned to either control or a 12-session standardised curriculum based on the comprehensive social influence model. Randomisation was blocked within socioeconomic levels of the school environment. Alcohol use and alcohol-related problem behaviours were investigated through a self-completed anonymous questionnaire at baseline and 18 months thereafter. Data were analysed using multilevel models, separately by socioeconomic level. Results At baseline, adolescents in schools of low socioeconomic level were more likely to report problem drinking than other students. Participation in the programme was associated in this group with a decreased odds of reporting episodes of drunkenness (OR = 0.60, 95% CI = 0.44-0.83, intention to get drunk (OR = 0.60, 95% CI = 0.45-0.79, and marginally alcohol-related problem behaviours (OR = 0.70, 95% CI = 0.46-1.06. No significant programme's effects emerged for students in schools of medium or high socioeconomic level. Effects on frequency of alcohol consumption were also stronger among students in disadvantaged schools, although the estimates did not attain statistical significance in any subgroup. Conclusions It is plausible that comprehensive social influence programmes have a more favourable effect on problematic drinking among students in underprivileged social environments. Trial registration ISRCTN: ISRCTN

  17. A designated centre for people with disabilities operated by Daughters of Charity Disability Support Services Ltd. -Dublin 15

    LENUS (Irish Health Repository)

    Dinneen, Seán F

    2009-01-01

    BACKGROUND: Structured education programmes for individuals with Type 1 diabetes have become a recognised means of delivering the knowledge and skills necessary for optimal self-management of the condition. The Dose Adjustment for Normal Eating (DAFNE) programme has been shown to improve biomedical (HbA(1c) and rates of severe hypoglycaemia) and psychosocial outcomes for up to 12 months following course delivery. The optimal way to support DAFNE graduates and maintain the benefits of the programme has not been established. We aimed to compare 2 different methods of follow-up of DAFNE graduates in a pragmatic clinical trial delivered in busy diabetes clinics on the island of Ireland. METHODS: Six participating centres were cluster randomised to deliver either group follow-up or a return to traditional one-to-one clinic visits. In the intervention arm group follow-up was delivered at 6 and 12 months post DAFNE training according to a curriculum developed for the study. In the control arm patients were seen individually in diabetes clinics as part of routine care. Study outcomes included HbA(1c) levels, self-reported rates of severe hypoglycaemia, body weight and measures of diabetes wellbeing and quality of life. These were measured at 6, 12 and 18 months after recruitment. Generalisability (external validity) was maximised by recruiting study participants from existing DAFNE waiting lists in each centre, by using broad inclusion criteria (including HbA(1c) values less than 13 percent with no lower limit) and by using existing clinic staff to deliver the training and follow-up. Internal validity and treatment fidelity were maximised by quality assuring the training of all DAFNE educators, by external peer review of the group follow-up sessions and by striving for full attendance at follow-up visits. Assays of HbA(1c) were undertaken in a central laboratory. DISCUSSION: This pragmatic clinical trial evaluating group follow-up after a structured education programme has

  18. Total ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trial

    Science.gov (United States)

    Goldberg, Andrew J; Zaidi, Razi; Thomson, Claire; Doré, Caroline J; Cro, Suzie; Round, Jeff; Molloy, Andrew; Davies, Mark; Karski, Michael; Kim, Louise; Cooke, Paul

    2016-01-01

    Introduction Total ankle replacement (TAR) or ankle arthrodesis (fusion) is the main surgical treatments for end-stage ankle osteoarthritis (OA). The popularity of ankle replacement is increasing while ankle fusion rates remain static. Both treatments have efficacy but to date all studies comparing the 2 have been observational without randomisation, and there are no published guidelines as to the most appropriate management. The TAR versus arthrodesis (TARVA) trial aims to compare the clinical and cost-effectiveness of TAR against ankle arthrodesis in the treatment of end-stage ankle OA in patients aged 50–85 years. Methods and analysis TARVA is a multicentre randomised controlled trial that will randomise 328 patients aged 50–85 years with end-stage ankle arthritis. The 2 arms of the study will be TAR or ankle arthrodesis with 164 patients in each group. Up to 16 UK centres will participate. Patients will have clinical assessments and complete questionnaires before their operation and at 6, 12, 26 and 52 weeks after surgery. The primary clinical outcome of the study is a validated patient-reported outcome measure, the Manchester Oxford foot questionnaire, captured preoperatively and 12 months after surgery. Secondary outcomes include quality-of-life scores, complications, revision, reoperation and a health economic analysis. Ethics and dissemination The protocol has been approved by the National Research Ethics Service Committee (London, Bloomsbury 14/LO/0807). This manuscript is based on V.5.0 of the protocol. The trial findings will be disseminated through peer-reviewed publications and conference presentations. Trial registration number NCT02128555. PMID:27601503

  19. A randomised controlled trial evaluating family mediated exercise (FAME therapy following stroke

    Directory of Open Access Journals (Sweden)

    Stokes Emma

    2008-06-01

    Full Text Available Abstract Background Stroke is a leading cause of disability among adults worldwide. Evidence suggests that increased duration of exercise therapy following stroke has a positive impact on functional outcome following stroke. The main objective of this randomised controlled trial is to evaluate the impact of additional family assisted exercise therapy in people with acute stroke. Methods/Design A prospective multi-centre single blind randomised controlled trial will be conducted. Forty patients with acute stroke will be randomised into either an experimental or control group. The experimental group will receive routine therapy and additional lower limb exercise therapy in the form of family assisted exercises. The control group will receive routine therapy with no additional formal input from their family members. Participants will be assessed at baseline, post intervention and followed up at three months using a series of standardised outcome measures. A secondary aim of the project is to evaluate the impact of the family mediated exercise programme on the person with stroke and the individual(s assisting in the delivery of exercises using a qualitative methodology. The study has gained ethical approval from the Research Ethics Committees of each of the clinical sites involved in the study. Discussion This study will evaluate a structured programme of exercises that can be delivered to people with stroke by their 'family members/friends'. Given that the progressive increase in the population of older people is likely to lead to an increased prevalence of stroke in the future, it is important to reduce the burden of this illness on the individual, the family and society. Family mediated exercises can maximise the carry over outside formal physiotherapy sessions, giving patients the opportunity for informal practice. Trial Registration The protocol for this study is registered with the US NIH Clinical trials registry (NCT00666744

  20. A randomised controlled trial evaluating family mediated exercise (FAME) therapy following stroke

    Science.gov (United States)

    Galvin, Rose; Cusack, Tara; Stokes, Emma

    2008-01-01

    Background Stroke is a leading cause of disability among adults worldwide. Evidence suggests that increased duration of exercise therapy following stroke has a positive impact on functional outcome following stroke. The main objective of this randomised controlled trial is to evaluate the impact of additional family assisted exercise therapy in people with acute stroke. Methods/Design A prospective multi-centre single blind randomised controlled trial will be conducted. Forty patients with acute stroke will be randomised into either an experimental or control group. The experimental group will receive routine therapy and additional lower limb exercise therapy in the form of family assisted exercises. The control group will receive routine therapy with no additional formal input from their family members. Participants will be assessed at baseline, post intervention and followed up at three months using a series of standardised outcome measures. A secondary aim of the project is to evaluate the impact of the family mediated exercise programme on the person with stroke and the individual(s) assisting in the delivery of exercises using a qualitative methodology. The study has gained ethical approval from the Research Ethics Committees of each of the clinical sites involved in the study. Discussion This study will evaluate a structured programme of exercises that can be delivered to people with stroke by their 'family members/friends'. Given that the progressive increase in the population of older people is likely to lead to an increased prevalence of stroke in the future, it is important to reduce the burden of this illness on the individual, the family and society. Family mediated exercises can maximise the carry over outside formal physiotherapy sessions, giving patients the opportunity for informal practice. Trial Registration The protocol for this study is registered with the US NIH Clinical trials registry (NCT00666744) PMID:18570643

  1. SMART: Self-Management of Anticoagulation, a Randomised Trial [ISRCTN19313375

    Directory of Open Access Journals (Sweden)

    Murray Ellen T

    2003-09-01

    Full Text Available Abstract Background Oral anticoagulation monitoring has traditionally taken place in secondary care because of the need for a laboratory blood test, the international normalised ratio (INR. The development of reliable near patient testing (NPT systems for INR estimation has facilitated devolution of testing to primary care. Patient self-management is a logical progression from the primary care model. This study will be the first to randomise non-selected patients in primary care, to either self-management or standard care. Method The study was a multi-centred randomised controlled trial with patients from 49 general practices recruited. Those suitable for inclusion were aged 18 or over, with a long term indication for oral anticoagulation, who had taken warfarin for at least six months. Patients randomised to the intervention arm attended at least two training sessions which were practice-based, 1 week apart. Each patient was assessed on their capability to undertake self management. If considered capable, they were given a near patient INR testing monitor, test strips and quality control material for home testing. Patients managed their own anticoagulation for a period of 12 months and performed their INR test every 2 weeks. Control patients continued with their pre-study care either attending hospital or practice based anticoagulant clinics. Discussion The methodology used in this trial will overcome concerns from previous trials of selection bias and relevance to the UK health service. The study will give a clearer understanding of the benefits of self-management in terms of clinical and cost effectiveness and patient preference.

  2. The Galactic centre pulsar population

    CERN Document Server

    Chennamangalam, Jayanth

    2013-01-01

    The recent discovery of a magnetar in the Galactic centre region has allowed Spitler et al. to characterize the interstellar scattering in that direction. They find that the temporal broadening of the pulse profile of the magnetar is substantially less than that predicted by models of the electron density of that region. This raises the question of what the plausible limits for the number of potentially observable pulsars - i.e., the number of pulsars beaming towards the Earth - in the Galactic centre region are. In this paper, using realistic assumptions, we show that the potentially observable population of pulsars in the inner parsec has a conservative upper limit of $\\sim$950, and that it is premature to conclude that the number of pulsars in this region is small. We also show that the observational results so far are consistent with this number and make predictions for future radio pulsar surveys of the Galactic centre.

  3. Construction of the Wigner Data Centre

    CERN Multimedia

    2013-01-01

    A remote extension of the CERN data centre has recently been inaugurated. Hosted at the Wigner Research Centre for Physics in Hungary, it provides extra computing power required to cover CERN’s needs. This video presents the construction of the Wigner Data Centre from initial demolishing work through to its completion and details the major technical characteristics of the Data Centre.

  4. Observer bias in randomised clinical trials with binary outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida;

    2012-01-01

    To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes.......To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes....

  5. Producing the BEANs needed for person-centred healthcare decision making requires translating the wisdom of the clinical crowd

    DEFF Research Database (Denmark)

    Kaltoft, Mette Kjer; Eiring, Øystein; Nielsen, Jesper Bo;

    Producing the BEANs needed for person-centred healthcare decision making requires translating the wisdom of the clinical crowd Mette Kjer Kaltoft, University of Southern Denmark Øystein Eiring, Norwegian Knowledge Centre for the Health Services Jesper Bo Nielsen, University of Southern Denmark...... Glenn Salkeld, University of Sydney School of Public Health Jack Dowie, London School of Hygiene and Tropical Medicine (presenting) Abstract (500) Person-centred care is the increasingly avowed aim of health services and professionals. To be meaningful such care requires a shared decision making process...... validation in this respect, we have a situation where demonstrated scientific rigour is simultaneously regarded as essential and irrelevant to clinical decision making. Attempts to increase the external validity of scientific studies (notably randomised controlled trials) are attractive to many, but can...

  6. Randomised Controlled Trials in Education Research: A Case Study of an Individually Randomised Pragmatic Trial

    Science.gov (United States)

    Torgerson, Carole J.

    2009-01-01

    The randomised controlled trial (RCT) is an evaluative method used by social scientists in order to establish whether or not an intervention is effective. This contribution discusses the fundamental aspects of good RCT design. These are illustrated through the use of a recently completed RCT which evaluated an information and communication…

  7. Isotopic clusters

    International Nuclear Information System (INIS)

    Spectra of isotopically mixed clusters (dimers of SF6) are calculated as well as transition frequencies. The result leads to speculations about the suitability of the laser-cluster fragmentation process for isotope separation. (Auth.)

  8. Meaningful Clusters

    Energy Technology Data Exchange (ETDEWEB)

    Sanfilippo, Antonio P.; Calapristi, Augustin J.; Crow, Vernon L.; Hetzler, Elizabeth G.; Turner, Alan E.

    2004-05-26

    We present an approach to the disambiguation of cluster labels that capitalizes on the notion of semantic similarity to assign WordNet senses to cluster labels. The approach provides interesting insights on how document clustering can provide the basis for developing a novel approach to word sense disambiguation.

  9. LDE centres: sprint or marathon?

    NARCIS (Netherlands)

    Bonger, S.; Van Rein, E.

    2015-01-01

    The aim of the Strategic Leiden-Delft-Erasmus Alliance, established by the three universities in 2012, was to improve research and education and competitiveness. Projects are intended to develop from the ground up, which led to the establishment of eight joint centres in 2013. A quick look around re

  10. Levonorgestrel-releasing intrauterine system vs. usual medical treatment for menorrhagia: an economic evaluation alongside a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Sabina Sanghera

    Full Text Available OBJECTIVE: To undertake an economic evaluation alongside the largest randomised controlled trial comparing Levonorgestrel-releasing intrauterine device ('LNG-IUS' and usual medical treatment for women with menorrhagia in primary care; and compare the cost-effectiveness findings using two alternative measures of quality of life. METHODS: 571 women with menorrhagia from 63 UK centres were randomised between February 2005 and July 2009. Women were randomised to having a LNG-IUS fitted, or usual medical treatment, after discussing with their general practitioner their contraceptive needs or desire to avoid hormonal treatment. The treatment was specified prior to randomisation. For the economic evaluation we developed a state transition (Markov model with a 24 month follow-up. The model structure was informed by the trial women's pathway and clinical experts. The economic evaluation adopted a UK National Health Service perspective and was based on an outcome of incremental cost per Quality Adjusted Life Year (QALY estimated using both EQ-5D and SF-6D. RESULTS: Using EQ-5D, LNG-IUS was the most cost-effective treatment for menorrhagia. LNG-IUS costs £100 more than usual medical treatment but generated 0.07 more QALYs. The incremental cost-effectiveness ratio for LNG-IUS compared to usual medical treatment was £1600 per additional QALY. Using SF-6D, usual medical treatment was the most cost-effective treatment. Usual medical treatment was both less costly (£100 and generated 0.002 more QALYs. CONCLUSION: Impact on quality of life is the primary indicator of treatment success in menorrhagia. However, the most cost-effective treatment differs depending on the quality of life measure used to estimate the QALY. Under UK guidelines LNG-IUS would be the recommended treatment for menorrhagia. This study demonstrates that the appropriate valuation of outcomes in menorrhagia is crucial.

  11. Pressure and pain In Systemic sclerosis/Scleroderma - an evaluation of a simple intervention (PISCES: randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Alcacer-Pitarch Begonya

    2012-02-01

    Full Text Available Abstract Background Foot problems associated with Systemic Sclerosis (SSc/Scleroderma have been reported to be both common and disabling. There are only limited data describing specifically, the mechanical changes occurring in the foot in SSc. A pilot project conducted in preparation for this trial confirmed the previous reports of foot related impairment and reduced foot function in people with SSc and demonstrated a link to mechanical etiologies. To-date there have been no formal studies of interventions directed at the foot problems experienced by people with Systemic Sclerosis. The primary aim of this trial is to evaluate whether foot pain and foot-related health status in people with Systemic Sclerosis can be improved through the provision of a simple pressure-relieving insole. Methods The proposed trial is a pragmatic, multicenter, randomised controlled clinical trial following a completed pilot study. In four participating centres, 140 consenting patients with SSc and plantar foot pain will be randomised to receive either a commercially available pressure relieving and thermally insulating insole, or a sham insole with no cushioning or thermal properties. The primary end point is a reduction in pain measured using the Foot Function Index Pain subscale, 12 weeks after the start of intervention. Participants will complete the primary outcome measure (Foot Function Index pain sub-scale prior to randomisation and at 12 weeks post randomisation. Secondary outcomes include participant reported pain and disability as derived from the Manchester Foot Pain and Disability Questionnaire and plantar pressures with and without the insoles in situ. Discussion This trial protocol proposes a rigorous and potentially significant evaluation of a simple and readily provided therapeutic approach which, if effective, could be of a great benefit for this group of patients. Trial registration number ISRCTN: ISRCTN02824122

  12. A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034

    Directory of Open Access Journals (Sweden)

    Ashby Rebecca L

    2012-07-01

    Full Text Available Abstract Background Negative pressure wound therapy (NPWT is widely promoted as a treatment for full thickness wounds; however, there is a lack of high-quality research evidence regarding its clinical and cost effectiveness. A trial of NPWT for the treatment of grade III/IV pressure ulcers would be worthwhile but premature without assessing whether such a trial is feasible. The aim of this pilot randomised controlled trial was to assess the feasibility of conducting a future full trial of NPWT for the treatment of grade III and IV pressure ulcers and to pilot all aspects of the trial. Methods This was a two-centre (acute and community, pilot randomised controlled trial. Eligible participants were randomised to receive either NPWT or standard care (SC (spun hydrocolloid, alginate or foam dressings. Outcome measures were time to healing of the reference pressure ulcer, recruitment rates, frequency of treatment visits, resources used and duration of follow-up. Results Three hundred and twelve patients were screened for eligibility into this trial over a 12-month recruitment period and 12/312 participants (3.8% were randomised: 6 to NPWT and 6 to SC. Only one reference pressure ulcer healed (NPWT group during follow-up (time to healing 79 days. The mean number of treatment visits per week was 3.1 (NPWT and 5.7 (SC; 6/6 NPWT and 1/6 SC participants withdrew from their allocated trial treatment. The mean duration of follow-up was 3.8 (NPWT and 5.0 (SC months. Conclusions This pilot trial yielded vital information for the planning of a future full study including projected recruitment rate, required duration of follow-up and extent of research nurse support required. Data were also used to inform the cost-effectiveness and value of information analyses, which were conducted alongside the pilot trial. Trial registration Current Controlled Trials ISRCTN69032034.

  13. Positive effects on bone mineralisation and muscular fitness after 10 months of intense school-based physical training for children aged 8–10 years: the FIT FIRST randomised controlled trial

    DEFF Research Database (Denmark)

    Larsen, Malte Nejst; Nielsen, Claus Malta; Helge, Eva Wulff;

    2016-01-01

    Objectives We investigated whether musculoskeletal fitness of school children aged 8–10 years was affected by frequent intense PE sessions. Design and participants 295 Danish school children aged 8–10 years were cluster randomised to a small-sided ball game group (SSG) (n=96, four schools, five c...

  14. Effective Clustering Algorithms for Gene Expression Data

    CERN Document Server

    Chandrasekhar, T; Elayaraja, E

    2012-01-01

    Microarrays are made it possible to simultaneously monitor the expression profiles of thousands of genes under various experimental conditions. Identification of co-expressed genes and coherent patterns is the central goal in microarray or gene expression data analysis and is an important task in Bioinformatics research. In this paper, K-Means algorithm hybridised with Cluster Centre Initialization Algorithm (CCIA) is proposed Gene Expression Data. The proposed algorithm overcomes the drawbacks of specifying the number of clusters in the K-Means methods. Experimental analysis shows that the proposed method performs well on gene Expression Data when compare with the traditional K- Means clustering and Silhouette Coefficients cluster measure.

  15. GENetic and clinical Predictors Of treatment response in Depression: the GenPod randomised trial protocol

    Directory of Open Access Journals (Sweden)

    O'Donovan Michael

    2008-05-01

    Full Text Available Abstract Background The most effective pharmacological treatments for depression inhibit the transporters that reuptake serotonin (Selective Serotonin Reuptake Inhibitors – SSRIs and noradrenaline (Noradrenaline Reuptake Inhibitors – NaRIs into the presynaptic terminal. There is evidence to suggest that noradrenaline and serotonin enhancing drugs work through separate mechanisms to produce their clinical antidepressant action. Although most of the current evidence suggests there is little difference in overall efficacy between SSRIs and NaRIs, there are patients who respond to one class of compounds and not another. This suggests that treatment response could be predicted by genetic and/or clinical characteristics. Firstly, this study aims to investigate the influence of a polymorphism (SLC6A4 in the 5HT transporter in altering response to SSRI medication. Secondly, the study will investigate whether those with more severe depression have a better response to NaRIs than SSRIs. Methods/design The GenPod trial is a multi-centre randomised controlled trial. GPs referred patients aged between 18–74 years presenting with a new episode of depression, who did not have any medical contraindications to antidepressant medication and who had no history of psychosis or alcohol/substance abuse. Patients were interviewed to ascertain their suitability for the study. Eligible participants (with a primary diagnosis of depression according to ICD10 criteria and a Beck Depression Inventory (BDI score > 14 were randomised to receive one of two antidepressant treatments, either the SSRI Citalopram or the NaRI Reboxetine, stratified according to severity. The final number randomised to the trial was 601. Follow-up assessments took place at 2, 6 and 12 weeks following randomisation. Primary outcome was measured at 6 weeks by the BDI. Outcomes will be analysed on an intention-to-treat basis and will use multiple regression models to compare treatments

  16. Ultrasound in management of rheumatoid arthritis: ARCTIC randomised controlled strategy trial

    Science.gov (United States)

    Aga, Anna-Birgitte; Olsen, Inge Christoffer; Lillegraven, Siri; Hammer, Hilde B; Uhlig, Till; Fremstad, Hallvard; Madland, Tor Magne; Lexberg, Åse Stavland; Haukeland, Hilde; Rødevand, Erik; Høili, Christian; Stray, Hilde; Noraas, Anne; Hansen, Inger Johanne Widding; Bakland, Gunnstein; Nordberg, Lena Bugge; van der Heijde, Désirée; Kvien, Tore K

    2016-01-01

    Objective To determine whether a treatment strategy based on structured ultrasound assessment would lead to improved outcomes in rheumatoid arthritis, compared with a conventional strategy. Design Multicentre, open label, two arm, parallel group, randomised controlled strategy trial. Setting Ten rheumatology departments and one specialist centre in Norway, from September 2010 to September 2015. Participants 238 patients were recruited between September 2010 and April 2013, of which 230 (141 (61%) female) received the allocated intervention and were analysed for the primary outcome. The main inclusion criteria were age 18-75 years, fulfilment of the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis, disease modifying anti-rheumatic drug naivety with indication for disease modifying drug therapy, and time from first patient reported swollen joint less than two years. Patients with abnormal kidney or liver function or major comorbidities were excluded. Interventions 122 patients were randomised to an ultrasound tight control strategy targeting clinical and imaging remission, and 116 patients were randomised to a conventional tight control strategy targeting clinical remission. Patients in both arms were treated according to the same disease modifying anti-rheumatic drug escalation strategy, with 13 visits over two years. Main outcome measures The primary endpoint was the proportion of patients with a combination between 16 and 24 months of clinical remission, no swollen joints, and non-progression of radiographic joint damage. Secondary outcomes included measures of disease activity, radiographic progression, functioning, quality of life, and adverse events. All participants who attended at least one follow-up visit were included in the full analysis set. Results 26 (22%) of the 118 analysed patients in the ultrasound tight control arm and 21 (19%) of the 112 analysed patients in the

  17. Large-scale cluster state generation with nuclear spins in diamonds

    International Nuclear Information System (INIS)

    The cluster state is an indispensable resource for one-way quantum computing (1WQC). We propose a practical scheme for constructing cluster states among nuclear spins in nitrogen-vacancy defect centres (NV centres) in different diamonds. The entanglement of nuclear spins within an NV centre is made by hyperfine coupling via electron spin, and the entanglement between remote NV centres is accomplished using the parity projection of emitted photons. We discus the possibility to build large-scale nuclear-spin cluster states with diamonds. (general)

  18. The formation mechanism and the binding energy of the body-centred regular tetrahedral structure of He+5

    Institute of Scientific and Technical Information of China (English)

    李萍; 熊勇; 芶清泉; 张建平

    2002-01-01

    We propose the formation mechanism of the body-centred regular tetrahedral structure of the He+5 cluster. The total energy curve for this structure has been calculated by using a modified arrangement channel quantum mechanics method. The result shows that a minimal energy of -13.9106 a.u. occurs at a separation of 1.14a0 between the nucleus at the centre and nuclei at the apexes. Therefore we obtain the binding energy of 0.5202 a.u. for this structure. This means that the He+5 cluster may be stable with a high binding energy in a body-centred regular tetrahedral structure.

  19. Data Clustering

    Science.gov (United States)

    Wagstaff, Kiri L.

    2012-03-01

    On obtaining a new data set, the researcher is immediately faced with the challenge of obtaining a high-level understanding from the observations. What does a typical item look like? What are the dominant trends? How many distinct groups are included in the data set, and how is each one characterized? Which observable values are common, and which rarely occur? Which items stand out as anomalies or outliers from the rest of the data? This challenge is exacerbated by the steady growth in data set size [11] as new instruments push into new frontiers of parameter space, via improvements in temporal, spatial, and spectral resolution, or by the desire to "fuse" observations from different modalities and instruments into a larger-picture understanding of the same underlying phenomenon. Data clustering algorithms provide a variety of solutions for this task. They can generate summaries, locate outliers, compress data, identify dense or sparse regions of feature space, and build data models. It is useful to note up front that "clusters" in this context refer to groups of items within some descriptive feature space, not (necessarily) to "galaxy clusters" which are dense regions in physical space. The goal of this chapter is to survey a variety of data clustering methods, with an eye toward their applicability to astronomical data analysis. In addition to improving the individual researcher’s understanding of a given data set, clustering has led directly to scientific advances, such as the discovery of new subclasses of stars [14] and gamma-ray bursts (GRBs) [38]. All clustering algorithms seek to identify groups within a data set that reflect some observed, quantifiable structure. Clustering is traditionally an unsupervised approach to data analysis, in the sense that it operates without any direct guidance about which items should be assigned to which clusters. There has been a recent trend in the clustering literature toward supporting semisupervised or constrained

  20. The INTEGRAL Science Data Centre

    OpenAIRE

    Beckmann, V.

    2002-01-01

    The INTEGRAL Science Data Centre (ISDC) processes, archives and distributes data from the INTEGRAL mission. At the ISDC incoming data from the satellite are processed and searched for transient sources and Gamma-Ray bursts. The data are archived and distributed to the guest observers. As soon as the data are public, any astronomer can access the data via the internet. ISDC also provides the tools which are necessary for the data analysis and offers user support concerning questions related to...

  1. Radwaste Treatment Centre Jaslovske Bohunice

    International Nuclear Information System (INIS)

    In this leaflet the Bohunice Radwaste Treatment Centre (BSC RAO) is presented. BSC RAO is designed to process and treat liquid and solid radwaste, arising from the NPP A-1 decommissioning, from NPPs V-1, V-2, and Mochovce operations, as well as institutional radwaste of diverse institutional (hospitals, research institutes) in the Slovak Republic. Transport, sorting, incineration, compacting, concentration and cementation of radwaste as well as monitoring of emission are described

  2. Protocol for a randomised controlled trial of a school based cognitive behaviour therapy (CBT) intervention to prevent depression in high risk adolescents (PROMISE).

    OpenAIRE

    Sayal Kapil; Lewis Glynn; Anderson Rob; Araya Ricardo; Montgomery Alan A; Stallard Paul; Buck Rhiannon; Millings Abigail; Taylor John A

    2010-01-01

    Abstract Background Depression in adolescents is a significant problem that impairs everyday functioning and increases the risk of severe mental health disorders in adulthood. Relatively few adolescents with depression are identified and referred for treatment indicating the need to investigate alternative preventive approaches. Study Design A pragmatic cluster randomised controlled trial evaluating the effectiveness of a school based prevention programme on symptoms of depression in "high ri...

  3. Effects of telephone health mentoring in community-recruited chronic obstructive pulmonary disease on self-management capacity, quality of life and psychological morbidity: a randomised controlled trial

    OpenAIRE

    Walters, Julia; Cameron-Tucker, Helen; Wills, Karen; Schüz, Natalie; Scott, Jenn; Robinson, Andrew; Nelson, Mark; Turner, Paul; Wood-Baker, Richard; Walters, E Haydn

    2013-01-01

    Objectives To assess benefits of telephone-delivered health mentoring in community-based chronic obstructive pulmonary disease (COPD). Design Cluster randomised controlled trial. Setting Tasmanian general practices: capital city (11), large rural (3), medium rural (1) and small rural (16). Participants Patients were invited (1207) from general practitioner (GP) databases with COPD diagnosis and/or tiotropium prescription, response rate 49% (586), refused (176) and excluded (criteria: smoking ...

  4. An oral health intervention for people with serious mental illness (Three Shires Early Intervention Dental Trial): study protocol for a randomised controlled trial

    OpenAIRE

    Jones, Hannah F; Adams, Clive E; Clifton, Andrew; Simpson, Jayne; Tosh, Graeme; Peter F Liddle; Callaghan, Patrick; Yang, Min; Guo, Boliang; Furtado, Vivek

    2013-01-01

    Background: Oral health is an important part of general physical health and is essential for self-esteem, self-confidence and overall quality of life. There is a well-established link between mental illness and poor oral health. Oral health problems are not generally well recognized by mental health professionals and many patients experience barriers to treatment. Methods/Design: This is the protocol for a pragmatic cluster randomised trial that has been designed to fit within ...

  5. Understanding influences on teachers’ uptake and use of behaviour management strategies within the STARS trial: process evaluation protocol for a randomised controlled trial

    OpenAIRE

    Hansford, Lorraine; Sharkey, Siobhan; Edwards, Vanessa; Ukoumunne, Obioha; Byford, Sarah; Norwich, Brahm; Logan, Stuart; Ford, Tamsin

    2015-01-01

    Background The ‘Supporting Teachers And childRen in Schools’ (STARS) study is a cluster randomised controlled trial evaluating the Incredible Years Teacher Classroom Management (TCM) programme as a public health intervention. TCM is a 6 day training course delivered to groups of 8–12 teachers. The STARS trial will investigate whether TCM can improve children’s behaviour, attainment and wellbeing, reduce teachers’ stress and improve their self-efficacy. This protocol describes the methodology ...

  6. Quetiapine versus aripiprazole in children and adolescents with psychosis - protocol for the randomised, blinded clinical Tolerability and Efficacy of Antipsychotics (TEA) trial

    DEFF Research Database (Denmark)

    Pagsberg, Anne Katrine; Jeppesen, Pia; Klauber, Dea Gowers;

    2014-01-01

    weeks after randomisation. The primary outcome is change in the positive symptom score of the Positive and Negative Syndrome Scale. The recruitment period is 2010-2014. DISCUSSION: Antipsychotics are currently the only available pharmacologic treatments for psychotic disorders. However, information......BACKGROUND: The evidence for choices between antipsychotics for children and adolescents with schizophrenia and other psychotic disorders is limited. The main objective of the Tolerability and Efficacy of Antipsychotics (TEA) trial is to compare the benefits and harms of quetiapine versus...... aripiprazole in children and adolescents with psychosis in order to inform rational, effective and safe treatment selections. METHODS/DESIGN: The TEA trial is a Danish investigator-initiated, independently funded, multi-centre, randomised, blinded clinical trial. Based on sample size estimation, 112 patients...

  7. TIPIT: A randomised controlled trial of thyroxine in preterm infants under 28 weeks gestation: Magnetic Resonance Imaging and Magnetic Resonance Angiography protocol

    DEFF Research Database (Denmark)

    Sze M., Ng,; Mark A., Turner; Carrol, Gamble,;

    2008-01-01

    of the sub-arachnoid space measured using cranial ultrasound and head circumference at 36 weeks corrected gestational age. The secondary outcomes will be thyroid hormone concentrations, the hypothalamic pituitary axis status and auxological data between birth and expected date of delivery; thyroid gland...... on the developing foetal brain. This is an explanatory double blinded randomised controlled trial which is aimed to assess the effect of thyroid hormone supplementation on brain size, key brain structures, extent of myelination, white matter integrity and vessel morphology, somatic growth and the hypothalamic......-pituitary-adrenal axis. Methods The study is a multi-centred double blinded randomised controlled trial of thyroid hormone supplementation in babies born below 28 weeks' gestation. All infants will receive either levothyroxine or placebo until 32 weeks corrected gestational age. The primary outcomes will be width...

  8. Cluster Chemistry

    Institute of Scientific and Technical Information of China (English)

    2011-01-01

    @@ Cansisting of eight scientists from the State Key Laboratory of Physical Chemistry of Solid Surfaces and Xiamen University, this creative research group is devoted to the research of cluster chemistry and creation of nanomaterials.After three-year hard work, the group scored a series of encouraging progresses in synthesis of clusters with special structures, including novel fullerenes, fullerene-like metal cluster compounds as well as other related nanomaterials, and their properties study.

  9. RCT of a client-centred, caseworker-delivered smoking cessation intervention for a socially disadvantaged population

    Directory of Open Access Journals (Sweden)

    Girgis Afaf

    2011-01-01

    Full Text Available Abstract Background Disadvantaged groups are an important target for smoking cessation intervention. Smoking rates are markedly higher among severely socially disadvantaged groups such as indigenous people, the homeless, people with a mental illness or drug and alcohol addiction, and the unemployed than in the general population. This proposal aims to evaluate the efficacy of a client-centred, caseworker delivered cessation support intervention at increasing validated self reported smoking cessation rates in a socially disadvantaged population. Methods/Design A block randomised controlled trial will be conducted. The setting will be a non-government organisation, Community Care Centre located in New South Wales, Australia which provides emergency relief and counselling services to predominantly government income assistance recipients. Eligible clients identified as smokers during a baseline touch screen computer survey will be recruited and randomised by a trained research assistant located in the waiting area. Allocation to intervention or control groups will be determined by time periods with clients randomised in one-week blocks. Intervention group clients will receive an intensive client-centred smoking cessation intervention offered by the caseworker over two face-to-face and two telephone contacts. There will be two primary outcome measures obtained at one, six, and 12 month follow-up: 1 24-hour expired air CO validated self-reported smoking cessation and 2 7-day self-reported smoking cessation. Continuous abstinence will also be measured at six and 12 months follow up. Discussion This study will generate new knowledge in an area where the current information regarding the most effective smoking cessation approaches with disadvantaged groups is limited. Trial registration number ISRCTN: ISRCTN85202510

  10. The Notting Dale Urban Studies Centre

    Science.gov (United States)

    Webb, Chris; Lynas, Sue

    1976-01-01

    Founded in 1974, the Centre is one of the most intensively used resource centres in the United Kingdom. Adults and students from elementary to college level use its facilities to learn about the urban environment. (BD)

  11. Prevention of multiple pregnancies in couples with unexplained or mild male subfertility : Randomised controlled trial of in vitro fertilisation with single embryo transfer or in vitro fertilisation in modified natural cycle compared with intrauterine insemination with controlled ovarian hyperstimulation

    OpenAIRE

    Bensdorp, A J; Tjon-Kon-Fat, R. I.; Bossuyt, P.M.M.; Koks, C A M; Oosterhuis, G. J E; van Hoek, A.; Hompes, P.G.A.; Broekmans, F.J.M.; Verhoeve, H R; De Bruin, J. P.; van Golde, R.; Repping, S.; Cohlen, B.J.; Lambers, M D A; van Bommel, P F

    2015-01-01

    Objectives: To compare the effectiveness of in vitro fertilisation with single embryo transfer or in vitro fertilisation in a modified natural cycle with that of intrauterine insemination with controlled ovarian hyperstimulation in terms of a healthy child. Design: Multicentre, open label, three arm, parallel group, randomised controlled non-inferiority trial. Setting: 17 centres in the Netherlands. Participants: Couples seeking fertility treatment after at least 12 months of unprotected inte...

  12. Immobilisation versus immediate mobilisation after intrauterine insemination: randomised controlled trial

    NARCIS (Netherlands)

    I.M. Custers; P.A. Flierman; P. Maas; T. Cox; T.J.H.M. van Dessel; M.H. Gerards; M.H. Mochtar; C.A.H. Janssen; F. van der Veen; B.W.J. Mol

    2009-01-01

    Objective To evaluate the effectiveness of 15 minutes of immobilisation versus immediate mobilisation after intrauterine insemination. Design Randomised controlled trial. Setting One academic teaching hospital and six non-academic teaching hospitals. Participants Women having intrauterine inseminati

  13. Brief Intervention in Type 1 diabetes – Education for Self-efficacy (BITES: Protocol for a randomised control trial to assess biophysical and psychological effectiveness

    Directory of Open Access Journals (Sweden)

    Dromgoole Paul

    2007-09-01

    Full Text Available Abstract Background Self management is the cornerstone of effective preventive care in diabetes. Educational interventions that provide self-management skills for people with diabetes have been shown to reduce blood glucose concentrations. This in turn has the potential to reduce rates of complications. However, evidence to support type, quantity, setting and mode of delivery of self-management education is sparse. Objectives: To study the biophysical and psychological effectiveness of a brief psycho-educational intervention for type 1 diabetes in adults. Methods/Design Design: Randomised controlled clinical trial. Setting: Multidisciplinary specialist diabetes centre. Hypothesis: Our hypothesis was that the brief (2.5-day intervention would be biophysically and psychologically effective for people with type 1 diabetes. Intervention: A brief psycho-educational intervention for type 1 diabetes developed by a multi-professional team comprising of a consultant diabetologist, a diabetes specialist nurse, a specialist diabetes dietician and a clinical health psychologist and delivered in 20 hours over 2.5 days. Primary outcomes: HbA1c and severe hypoglycaemia. Secondary outcomes: Blood pressure, weight, height, lipid profile and composite psychometric scales. Participants: We shall consent and recruit 120 subjects with postal invitations sent to eligible participants. Volunteers are to be seen at randomisation clinics where independent researcher verify eligibility and obtain consent. We shall randomise 60 to BITES and 60 to standard care. Eligibility Criteria: Type 1 diabetes for longer than 12 months, multiple injection therapy for at least two months, minimum age of 18 and ability to read and write. Randomisation: An independent evaluator to block randomise (block-size = 6, to intervention or control groups using sealed envelopes in strict ascendant order. Control group will receive standard care. Assessment: Participants in both groups would

  14. Fuzzy Clustering

    DEFF Research Database (Denmark)

    Berks, G.; Keyserlingk, Diedrich Graf von; Jantzen, Jan;

    2000-01-01

    -mean clustering is an easy and well improved tool, which has been applied in many medical fields. We used c-mean fuzzy clustering after feature extraction from an aphasia database. Factor analysis was applied on a correlation matrix of 26 symptoms of language disorders and led to five factors. The factors...

  15. A Randomised Controlled Trial of complete denture impression materials

    OpenAIRE

    Hyde, T.P.; Craddock, H.L.; Gray, J C; Pavitt, S. H.; Hulme, C; Godfrey, M.; Fernandez, C; Navarro-Coy, N; Dillon, S.; Wright, J; S. Brown; Dukanovic, G.; Brunton, P.A.

    2014-01-01

    Objectives There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Methods Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Denta...

  16. Globular Clusters in the Galactic Bulge

    Science.gov (United States)

    Bica, E.; Ortolani, S.; Barbuy, B.

    2016-06-01

    A view of the Galactic bulge by means of their globular clusters is fundamental for a deep understanding of its formation and evolution. Connections between the globular cluster and field star properties in terms of kinematics, orbits, chemical abundances, and ages should shed light on different stellar population components. Based on spatial distribution and metallicity, we define a probable best list of bulge clusters, containing 43 entries. Future work on newly discovered objects, mostly from the VVV survey, is suggested. These candidates might alleviate the issue of missing clusters on the far side of the bulge. We discuss the reddening law affecting the cluster distances towards the centre of the Galaxy, and conclude that the most suitable total-to-selective absorption value appears to be R V=3.2, in agreement with recent analyses. An update of elemental abundances for bulge clusters is provided.

  17. Mass Distribution in Galaxy Cluster Cores

    CERN Document Server

    Hogan, M T; Pulido, F; Nulsen, P E J; Russell, H R; Vantyghem, A N; Edge, A C; Main, R A

    2016-01-01

    Many processes within galaxy clusters, such as those believed to govern the onset of thermally unstable cooling and AGN feedback, are dependent upon local dynamical timescales. However, accurately mapping the mass distribution within individual clusters is challenging, particularly towards cluster centres where the total mass budget has substantial radially-dependent contributions from the stellar, gas, and dark matter components. In this paper we use a small sample of galaxy clusters with deep Chandra observations and good ancillary tracers of their gravitating mass at both large and small radii to develop a method for determining mass profiles that span a wide radial range and extend down into the central galaxy. We also consider potential observational pitfalls in understanding cooling in hot cluster atmospheres, and find tentative evidence for a relationship between the radial extent of cooling X-ray gas and nebular H-alpha emission in cool core clusters. Amongst this small sample we find no support for t...

  18. A randomised controlled trial of intervention site radiotherapy in malignant pleural mesothelioma

    International Nuclear Information System (INIS)

    Background and purpose: To assess the effectiveness of radiotherapy in preventing tumour seeding after chest drain or pleural biopsy in patients with malignant mesothelioma and to determine, if tract metastases appear, whether they are tender or troublesome to patients. Patients and methods: Patients with a histological diagnosis of pleural mesothelioma and an invasive procedure within the preceding 21 days were stratified by age, performance status and treatment centre. Randomisation was performed between immediate drain site radiotherapy 21 Gy in three fractions (XRT arm) or best supportive care (BSC) with follow-up to 12 months. Patients were asked to complete questionnaires on treatment toxicity and on symptoms from any tract metastases detected. Results: Sixty-one patients were recruited from two centres between 1998 and 2004; 56 men, 5 women, median age 70. 31 were allocated to drain site radiotherapy. Seven patients developed tract metastases associated with the drain site (four XRT arm, three BSC) and four developed metastases associated with subsequent procedures at other sites (three XRT, one BSC). Two patients each developed two tract metastases. Of the 12 metastases, nine overlay the previous drain site but three were adjacent to the site. No statistically significant difference was found in the risk of tract metastasis associated with the drain site between the arms (p = 0.748). Conclusions: Prophylactic drain site radiotherapy in malignant pleural mesothelioma does not reduce the incidence of tumour seeding by the margin indicated by previous studies

  19. Scheduling participants of Assessment Centres

    DEFF Research Database (Denmark)

    Lysgaard, Jens; Løber, Janni

      Assessment Centres are used as a tool for psychologists and coaches to observe a number of dimensions in a person's behaviour and test his/her potential within a number of chosen focus areas. This is done in an intense course, with a number of different exercises which expose each participant......'s ability level in the chosen focus areas. The participants are observed by assessors with the purpose of gathering material for reaching a conclusion on each participant's personal profile. We consider the particular case that arises at the company Human Equity (www.humanequity.dk), where Assessment...

  20. The Hawthorne Effect: a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    van Haselen Robbert

    2007-07-01

    Full Text Available Abstract Background The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia. Methods Participants in a dementia trial were randomised to intensive follow-up (with comprehensive assessment visits at baseline and two, four and six months post randomisation or minimal follow-up (with an abbreviated assessment at baseline and a full assessment at six months. Our primary outcomes were cognitive functioning (ADAS-Cog and participant and carer-rated quality of life (QOL-AD. Results We recruited 176 participants, mainly through general practices. The main analysis was based on Intention to treat (ITT, with available data. In the ANCOVA model with baseline score as a co-variate, follow-up group had a significant effect on outcome at six months on the ADAS-Cog score (n = 140; mean difference = -2.018; 95%CI -3.914, -0.121; p = 0.037 favouring the intensive follow-up group, and on participant-rated quality of life score (n = 142; mean difference = -1.382; 95%CI -2.642, -0.122; p = 0.032 favouring minimal follow-up group. There was no significant difference on carer quality of life. Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia resulted in a better outcome than minimal follow-up, as measured by their cognitive functioning. Trial registration Current controlled trials: ISRCTN45577048

  1. Prehospital randomised assessment of a mechanical compression device in cardiac arrest (PaRAMeDIC trial protocol

    Directory of Open Access Journals (Sweden)

    McCabe Chris

    2010-11-01

    Full Text Available Abstract Background Survival after out-of-hospital cardiac arrest is closely linked to the quality of CPR, but in real life, resuscitation during prehospital care and ambulance transport is often suboptimal. Mechanical chest compression devices deliver consistent chest compressions, are not prone to fatigue and could potentially overcome some of the limitations of manual chest compression. However, there is no high-quality evidence that they improve clinical outcomes, or that they are cost effective. The Prehospital Randomised Assessment of a Mechanical Compression Device In Cardiac Arrest (PARAMEDIC trial is a pragmatic cluster randomised study of the LUCAS-2 device in adult patients with non-traumatic out-of-hospital cardiac arrest. Methods/design The primary objective of this trial is to evaluate the effect of chest compression using LUCAS-2 on mortality at 30 days post out-of-hospital cardiac arrest, compared with manual chest compression. Secondary objectives of the study are to evaluate the effects of LUCAS-2 on survival to 12 months, cognitive and quality of life outcomes and cost-effectiveness. Methods: Ambulance service vehicles will be randomised to either manual compression (control or LUCAS arms. Adult patients in out-of-hospital cardiac arrest, attended by a trial vehicle will be eligible for inclusion. Patients with traumatic cardiac arrest or who are pregnant will be excluded. The trial will recruit approximately 4000 patients from England, Wales and Scotland. A waiver of initial consent has been approved by the Research Ethics Committees. Consent will be sought from survivors for participation in the follow-up phase. Conclusion The trial will assess the clinical and cost effectiveness of the LUCAS-2 mechanical chest compression device. Trial Registration: The trial is registered on the International Standard Randomised Controlled Trial Number Registry (ISRCTN08233942.

  2. Aged Residential Care Health Utilisation Study (ARCHUS: a randomised controlled trial to reduce acute hospitalisations from residential aged care

    Directory of Open Access Journals (Sweden)

    Foster Susan J

    2012-09-01

    Full Text Available Abstract Background For residents of long term care, hospitalisations can cause distress and disruption, and often result in further medical complications. Multi-disciplinary team interventions have been shown to improve the health of Residential Aged Care (RAC residents, decreasing the need for acute hospitalisation, yet there are few randomised controlled trials of these complex interventions. This paper describes a randomised controlled trial of a structured multi-disciplinary team and gerontology nurse specialist (GNS intervention aiming to reduce residents’ avoidable hospitalisations. Methods/Design This Aged Residential Care Healthcare Utilisation Study (ARCHUS is a cluster- randomised controlled trial (n = 1700 residents of a complex multi-disciplinary team intervention in long-term care facilities. Eligible facilities certified for residential care were selected from those identified as at moderate or higher risk of resident potentially avoidable hospitalisations by statistical modelling. The facilities were all located in the Auckland region, New Zealand and were stratified by District Health Board (DHB. Intervention The intervention provided a structured GNS intervention including a baseline facility needs assessment, quality indicator benchmarking, a staff education programme and care coordination. Alongside this, three multi-disciplinary team (MDT meetings were held involving a geriatrician, facility GP, pharmacist, GNS and senior nursing staff. Outcomes Hospitalisations are recorded from routinely-collected acute admissions during the 9-month intervention period followed by a 5-month follow-up period. ICD diagnosis codes are used in a pre-specified definition of potentially reducible admissions. Discussion This randomised-controlled trial will evaluate a complex intervention to increase early identification and intervention to improve the health of residents of long term care. The results of this trial are expected in early

  3. Nuclear Star Clusters and Bulges

    CERN Document Server

    Cole, David R

    2015-01-01

    Nuclear star clusters are among the densest stellar systems known and are common in both early- and late-type galaxies. They exhibit scaling relations with their host galaxy which may be related to those of supermassive black holes. These may therefore help us to unravel the complex physical processes occurring at the centres of galaxies. The properties of nuclear stellar systems suggest that their formation requires both dissipational and dissipationless processes. They have stellar populations of different ages, from stars as old as their host galaxy to young stars formed in the last 100 Myr. Therefore star formation must be happening either directly in the nuclear star cluster or in its vicinity. The secular processes that fuel the formation of pseudobulges very likely also contributes to nuclear star cluster growth.

  4. Core Competencies Of A Call Centre AgentCore Competencies Of A Call Centre Agent

    OpenAIRE

    Christine White; Vera Roos

    2005-01-01

    Call centre agents are becoming increasingly important in the call centre context. They act as a contact point between the customer and the company. Call centre agents should have certain competencies to perform their duties sufficiently. Identifying competencies, required to be effective agents, will ease the task of training and recruitment. Due to the interrelatedness of the call centre agent, the management of a call centre and customers, all relevant role players’ perceptions were taken ...

  5. Perceptual centres in speech - an acoustic analysis

    Science.gov (United States)

    Scott, Sophie Kerttu

    Perceptual centres, or P-centres, represent the perceptual moments of occurrence of acoustic signals - the 'beat' of a sound. P-centres underlie the perception and production of rhythm in perceptually regular speech sequences. P-centres have been modelled both in speech and non speech (music) domains. The three aims of this thesis were toatest out current P-centre models to determine which best accounted for the experimental data bto identify a candidate parameter to map P-centres onto (a local approach) as opposed to the previous global models which rely upon the whole signal to determine the P-centre the final aim was to develop a model of P-centre location which could be applied to speech and non speech signals. The first aim was investigated by a series of experiments in which a) speech from different speakers was investigated to determine whether different models could account for variation between speakers b) whether rendering the amplitude time plot of a speech signal affects the P-centre of the signal c) whether increasing the amplitude at the offset of a speech signal alters P-centres in the production and perception of speech. The second aim was carried out by a) manipulating the rise time of different speech signals to determine whether the P-centre was affected, and whether the type of speech sound ramped affected the P-centre shift b) manipulating the rise time and decay time of a synthetic vowel to determine whether the onset alteration was had more affect on P-centre than the offset manipulation c) and whether the duration of a vowel affected the P-centre, if other attributes (amplitude, spectral contents) were held constant. The third aim - modelling P-centres - was based on these results. The Frequency dependent Amplitude Increase Model of P-centre location (FAIM) was developed using a modelling protocol, the APU GammaTone Filterbank and the speech from different speakers. The P-centres of the stimuli corpus were highly predicted by attributes of

  6. The new AMS control centre

    CERN Multimedia

    Anaïs Schaeffer

    2011-01-01

    Construction work for the future AMS control room began in November 2010 and should be finished this June. The new building, which will have been completed in record time thanks to the professionalism of the project team, will soon be ready to receive the initial data from the AMS experiment.     Luigi Scibile and Michael Poehler, from the GS department, at the AMS control centre construction site.   The Alpha Magnetic Spectrometer (AMS) is due to wing its way towards the International Space Station (ISS) on board the shuttle Discovery in April. Mainly intended for research on antimatter and dark matter, the data collected by AMS will be sent to Houston in the United States and then directly to CERN’s new Building 946. Construction work for the AMS control centre building on the Route Gentner at CERN’s Prévessin site started in November 2010 and must be completed in time to receive the first data from the spectrometer in June. “It normall...

  7. Weighted Clustering

    CERN Document Server

    Ackerman, Margareta; Branzei, Simina; Loker, David

    2011-01-01

    In this paper we investigate clustering in the weighted setting, in which every data point is assigned a real valued weight. We conduct a theoretical analysis on the influence of weighted data on standard clustering algorithms in each of the partitional and hierarchical settings, characterising the precise conditions under which such algorithms react to weights, and classifying clustering methods into three broad categories: weight-responsive, weight-considering, and weight-robust. Our analysis raises several interesting questions and can be directly mapped to the classical unweighted setting.

  8. Cluster analysis

    CERN Document Server

    Everitt, Brian S; Leese, Morven; Stahl, Daniel

    2011-01-01

    Cluster analysis comprises a range of methods for classifying multivariate data into subgroups. By organizing multivariate data into such subgroups, clustering can help reveal the characteristics of any structure or patterns present. These techniques have proven useful in a wide range of areas such as medicine, psychology, market research and bioinformatics.This fifth edition of the highly successful Cluster Analysis includes coverage of the latest developments in the field and a new chapter dealing with finite mixture models for structured data.Real life examples are used throughout to demons

  9. Cluster editing

    DEFF Research Database (Denmark)

    Böcker, S.; Baumbach, Jan

    2013-01-01

    The Cluster Editing problem asks to transform a graph into a disjoint union of cliques using a minimum number of edge modifications. Although the problem has been proven NP-complete several times, it has nevertheless attracted much research both from the theoretical and the applied side. The...... algorithms for biological problems. © 2013 Springer-Verlag....... problem has been the inspiration for numerous algorithms in bioinformatics, aiming at clustering entities such as genes, proteins, phenotypes, or patients. In this paper, we review exact and heuristic methods that have been proposed for the Cluster Editing problem, and also applications of these...

  10. Microsoft Hyper-V cluster design

    CERN Document Server

    Siron, Eric

    2013-01-01

    This book is written in a friendly and practical style with numerous tutorials centred on common as well as atypical Hyper-V cluster designs. This book also features a sample cluster design throughout to help you learn how to design a Hyper-V in a real-world scenario.Microsoft Hyper-V Cluster Design is perfect for the systems administrator who has a good understanding of Windows Server in an Active Directory domain and is ready to expand into a highly available virtualized environment. It only expects that you will be familiar with basic hypervisor terminology.

  11. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial

    DEFF Research Database (Denmark)

    Astrup, Arne; Madsbad, Sten; Breum, Leif;

    2008-01-01

    BACKGROUND: Weight-loss drugs produce an additional mean weight loss of only 3-5 kg above that of diet and placebo over 6 months, and more effective pharmacotherapy of obesity is needed. We assessed the efficacy and safety of tesofensine-an inhibitor of the presynaptic uptake of noradrenaline......, dopamine, and serotonin-in patients with obesity. METHODS: We undertook a phase II, randomised, double-blind, placebo-controlled trial in five Danish obesity management centres. After a 2 week run-in phase, 203 obese patients (body-mass index 30-...

  12. Centre for nuclear engineering University of Toronto annual report 1984

    International Nuclear Information System (INIS)

    The annual report of the Centre for Nuclear Engineering, University of Toronto covers the following subjects: message from the Dean; Chairman's message; origins of the centre; formation of the centre; new nuclear appointments; and activities of the centre, 1984

  13. On the distribution of galaxy ellipticity in clusters

    CERN Document Server

    D'Eugenio, Francesco; Davies, Roger L; Bontà, Elena Dalla

    2015-01-01

    We studied the distribution of projected ellipticity $\\epsilon$ for the galaxies in a sample of 20 rich ($\\mathcal{R} > 2$) nearby ($z 0.4), therefore it is not a consequence of the increasing fraction of intrinsically round Slow Rotator galaxies nearer the centre of clusters. The trend is also observed for flat, smooth galaxies and dividing the galaxies according to the shape of their light profile. This suggests that the systematic variation of the fraction of spiral galaxies with R does not explain alone the observed trend. We interpret our findings in light of the classification of Early Type Galaxies (ETGs) as Fast and Slow Rotators. We conclude that the observed trend of decreasing $\\epsilon$ nearer to the centre of clusters is evidence for physical effects in clusters causing Fast Rotator ETGs to have a lower average intrinsic ellipticity near the centre of rich clusters.

  14. Five-year follow up of a randomised controlled trial comparing subtotal with total abdominal hysterectomy

    DEFF Research Database (Denmark)

    Andersen, L L; Zobbe, V; Ottesen, B;

    2015-01-01

    OBJECTIVES: To compare the rates of urinary incontinence (UI) and other complications of subtotal abdominal hysterectomy (SAH) with total abdominal hysterectomy (TAH) at 5 years after surgery. DESIGN: Randomised clinical trial with central, computer-generated randomisation. SETTING: Danish multi-...

  15. Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials

    DEFF Research Database (Denmark)

    Savović, J; Jones, He; Altman, Dg;

    2012-01-01

    The design of randomised controlled trials (RCTs) should incorporate characteristics (such as concealment of randomised allocation and blinding of participants and personnel) that avoid biases resulting from lack of comparability of the intervention and control groups. Empirical evidence suggests...

  16. Powering the Future Data Centre

    DEFF Research Database (Denmark)

    Zhang, Zhe

    2010-01-01

    The extended run Uninterruptible Power Supply system (UPSs) which powered by fuel cells and supercapcitors, is a promising solution for future data centre to obtain environmentfriendly energy efficient and cost effective. There are many challenges in power electronic interface circuits, because......: • Optimized design method for dual active bridge (DAB) converter and its derived circuits; • A novel hybrid dc-dc converter and its corresponding optimal design method are proposed; • An improved dual input current-fed DC-DC converter with bidirectional power conversion ability is investigated; • Extend...... the circuit level decoupling modulation scheme into 3LNPC inverter. As to the DAB converter, through the power factor and harmonics analysis, the dominated loss factor is found in variable input voltage range. Optimized parameter choosing method is used to decide the ac inductance and switching frequency...

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

    Science.gov (United States)

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

    2010-02-01

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

  18. Experiences Constructing and Running Large Shared Clusters at CERN

    Institute of Scientific and Technical Information of China (English)

    VladimirBahyl; MaiteBarroso; 等

    2001-01-01

    The latest steps in the steady evolution of the CERN Computer Centre have been to reduce the multitude of clusters and architectures and to concentrate on commodity hardware.An active RISC decommissioning program has been undertaken to encourage migration to Linux,and a program of merging dedicated experiment clusters into larger shared facilities has been launched.This paper describes these programs and the experiences running the resultant multi-hundred node shared Linux clusters.

  19. Lopsidedness of cluster galaxies in modified gravity

    International Nuclear Information System (INIS)

    We point out an interesting theoretical prediction for elliptical galaxies residing inside galaxy clusters in the framework of modified Newtonian dynamics (MOND), tha