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Sample records for cadet multi-centre randomised

  1. 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...

  2. 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

  3. 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

  4. 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...

  5. 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 ...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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....

  11. 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

  12. 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

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

    Directory of Open Access Journals (Sweden)

    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.

  14. 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

  15. 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...

  16. 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...

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

    Directory of Open Access Journals (Sweden)

    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

  18. 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

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

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    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

  20. 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...

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

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    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

  2. 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.

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

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    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

  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

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    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. 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.

  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. 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...

  8. 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

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

    Directory of Open Access Journals (Sweden)

    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

  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

    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

  12. 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

  13. 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

  14. 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 ...

  15. 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

  16. 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

  17. Cadet lawyers applied professional training

    Directory of Open Access Journals (Sweden)

    Andrey B. Mednikov

    2011-07-01

    Full Text Available The article studies balance of successive protective actions against armed criminals relative to general physical fitness, emotional stability and will activity, experimentally justifies possibility of protective actions effectiveness improvement by means of cadet lawyers volitional qualities development.

  18. Authorship issues in multi-centre clinical trials

    DEFF Research Database (Denmark)

    Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian;

    2015-01-01

    Discussions about authorship often arise in multi-centre clinical trials. Such trials may involve up to hundreds of contributors of whom some will eventually co-author the final publication. It is, however, often impossible to involve all contributors in the manuscript process sufficiently for them...... to qualify for authorship as defined by the International Committee of Medical Journal Editors. Therefore, rules for authorship in multi-centre trials are strongly recommended. We propose two contracts to prevent conflicts regarding authorship; both are freely available for use without pay but with reference...

  19. Authorship issues in multi-centre clinical trials

    DEFF Research Database (Denmark)

    Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian;

    2015-01-01

    Discussions about authorship often arise in multi-centre clinical trials. Such trials may involve up to hundreds of contributors of whom some will eventually co-author the final publication. It is, however, often impossible to involve all contributors in the manuscript process sufficiently for them...

  20. 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...

  1. Proposal for the standardisation of multi-centre trials in nuclear medicine imaging

    DEFF Research Database (Denmark)

    Dickson, John Caddell; Tossici-Bolt, Livia; Sera, Terez;

    2012-01-01

    Multi-centre trials are an important part of proving the efficacy of procedures, drugs and interventions. Imaging components in such trials are becoming increasingly common; however, without sufficient control measures the usefulness of these data can be compromised. This paper describes a framew...... a framework for performing high-quality multi-centre trials with single photon emission computed tomography (SPECT), using a pan-European initiative to acquire a normal control dopamine transporter brain scan database as an example....

  2. 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 ...

  3. 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

  4. Obstetric risk indicators for labour dystocia in nulliparous women: a multi-centre cohort study

    DEFF Research Database (Denmark)

    Kjaergaard, H.; Olsen, J.; Ottesen, Bent Smedegaard;

    2008-01-01

    BACKGROUND: In nulliparous women dystocia is the most common obstetric problem and its etiology is largely unknown. The frequency of augmentation and cesarean delivery related to dystocia is high although it is not clear if a slow progress justifies the interventions. Studies of risk factors...... for dystocia often do not provide diagnostic criteria for the diagnosis. The aim of the present study was to identify obstetric and clinical risk indicators of dystocia defined by strict and explicit criteria. METHODS: A multi-centre population based cohort study with prospectively collected data from 2810...

  5. Harmonization process and reliability assessment of anthropometric measurements in the elderly EXERNET multi-centre study.

    Directory of Open Access Journals (Sweden)

    Alba Gómez-Cabello

    Full Text Available BACKGROUND: The elderly EXERNET multi-centre study aims to collect normative anthropometric data for old functionally independent adults living in Spain. PURPOSE: To describe the standardization process and reliability of the anthropometric measurements carried out in the pilot study and during the final workshop, examining both intra- and inter-rater errors for measurements. MATERIALS AND METHODS: A total of 98 elderly from five different regions participated in the intra-rater error assessment, and 10 different seniors living in the city of Toledo (Spain participated in the inter-rater assessment. We examined both intra- and inter-rater errors for heights and circumferences. RESULTS: For height, intra-rater technical errors of measurement (TEMs were smaller than 0.25 cm. For circumferences and knee height, TEMs were smaller than 1 cm, except for waist circumference in the city of Cáceres. Reliability for heights and circumferences was greater than 98% in all cases. Inter-rater TEMs were 0.61 cm for height, 0.75 cm for knee-height and ranged between 2.70 and 3.09 cm for the circumferences measured. Inter-rater reliabilities for anthropometric measurements were always higher than 90%. CONCLUSION: The harmonization process, including the workshop and pilot study, guarantee the quality of the anthropometric measurements in the elderly EXERNET multi-centre study. High reliability and low TEM may be expected when assessing anthropometry in elderly population.

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

    NARCIS (Netherlands)

    Bartels, R.H.M.A.; Verbeek, A.L.M.; Grotenhuis, J.A.

    2007-01-01

    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

  7. Prospective multi-centre randomised trial comparing induction of labour with a double-balloon catheter versus dinoprostone

    DEFF Research Database (Denmark)

    Løkkegaard, E; Lundstrøm, M; Kjær, Michael;

    2015-01-01

    group (difference not significant). After 24 h, 55.3% had given birth in the balloon group versus 54.3% in the dinoprostone group. Additional oxytocin stimulation was used more often in the balloon (46%) compared with that in the dinoprostone (34%) (relative risk: 1.34 (95%CI 1.16 -1.54) group....... Caesarean section rates and neonatal outcome were similar. Overall, the two methods for induction were comparable with regard to efficacy and safety....

  8. Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus

    OpenAIRE

    Ballmann, Manfred; Hubert, Dominique; Assael, Barouk M; Kronfeld, Kai; Honer, Marguerite; Holl, Reinhard W.

    2014-01-01

    Background Diabetes mellitus may be present in patients with cystic fibrosis starting in the second decade of life. The prevalence increases rapidly with increasing age. As life-expectancy increases in cystic fibrosis, cystic fibrosis related diabetes will be diagnosed more frequently in the future. Up to date, no data are available to answer the question if cystic fibrosis related diabetes should always initially be treated by insulin therapy. Missing data regarding oral antidiabetic treatme...

  9. Retrospective exposure assessment and quality control in an international multi-centre case-control study

    DEFF Research Database (Denmark)

    Tinnerberg, H; Heikkilä, P; Huici-Montagud, A;

    2003-01-01

    to the original CA studies at the time of CA testing, but not for the whole work life. An independent occupational hygienist coordinated harmonization of the assessment criteria and the quality control procedure. The reliability of the exposure assessments was calculated as deviation from the majority......The paper presents the exposure assessment method and quality control procedure used in an international, multi-centre case-control study within a joint Nordic and Italian cohort. This study was conducted to evaluate whether occupational exposure to carcinogens influenced the predictivity of high...... was higher among the original assessors (the assessor from the same country as the subject) than the average prevalence assessed by the other four in the quality control round. The original assessors classified more job situations as exposed than the others. Several reasons for this are plausible: real...

  10. Prescription errors in Brazilian hospitals: a multi-centre exploratory survey.

    Science.gov (United States)

    Miasso, Adriana Inocenti; Oliveira, Regina Célia de; Silva, Ana Elisa Bauer de Camargo; Lyra Junior, Divaldo Pereira de; Gimenes, Fernanda Raphael Escobar; Fakih, Flávio Trevisan; Cassiani, Sílvia Helena De Bortoli

    2009-02-01

    In Brazil, millions of prescriptions do not follow the legal requirements necessary to guarantee the correct dispensing and administration of medication. This multi-centre exploratory study aimed to analyze the appropriateness of prescriptions at four Brazilian hospitals and to identify possible errors caused by inadequacies. The sample consisted of 864 prescriptions obtained at hospital medical clinics in January 2003. Data was collected by three nurse researchers during one week using a standard data sheet that included items about: the type of prescription; legibility; completeness; use of abbreviations; existence of changes and erasures. There were statistically significant differences between incomplete electronic prescriptions at hospital A, and handwritten ones from hospitals C (C2 = 12.703 and p system at the hospitals. Physicians, pharmacists and nurses should therefore jointly propose strategies to avoid these prescription errors.

  11. Cadets' Perceptions of Gymnastics Instruction for Officer Development

    Science.gov (United States)

    Coelho, Jeffrey D.; Fielitz, Lynn R.

    2006-01-01

    The United States Military Academy has offered gymnastics instruction since 1838. Gymnastics continues to be an integral component of the physical education curriculum. The purpose of this study was to investigate cadets' perceptions of their experiences in a required gymnastics course using the critical incident technique. Students described…

  12. Personality Traits of Police Cadets: Relationship to Academy Performance.

    Science.gov (United States)

    Topp, Bruce W.; Kardash, Carol Anne

    A study examined the relationship of the personality traits of 94 police cadets to their performance at a southwestern state law enforcement academy. The overall training success (percentage of total points earned) of recruits enrolled in 11 weeks of on-site training classes was the primary criterion of the study, and raw personality factor scores…

  13. Current management of intracerebral haemorrhage in China: a national, multi-centre, hospital register study

    Directory of Open Access Journals (Sweden)

    Heeley Emma L

    2011-01-01

    Full Text Available Abstract Background We aimed to examine current practice of the management and secondary prevention of intracerebral haemorrhage (ICH in China where the disease is more common than in Western populations. Methods Data on baseline characteristics, management in-hospital and post-stroke, and outcome of ICH patients are from the ChinaQUEST (QUality Evaluation of Stroke Care and Treatment study, a multi-centre, prospective, 62 hospital registry in China during 2006-07. Results Nearly all ICH patients (n = 1572 received an intravenous haemodiluting agent such as mannitol (96% or a neuroprotectant (72%, and there was high use of intravenous traditional Chinese medicine (TCM (42%. Neurosurgery was undertaken in 137 (9% patients; being overweight, having a low Glasgow Coma Scale (GCS score on admission, and Total Anterior Circulation Syndrome (TACS clinical pattern on admission, were the only baseline factors associated with this intervention in multivariate analyses. Neurosurgery was associated with nearly three times higher risk of death/disability at 3 months post-stroke (odd ratio [OR] 2.60, p Conclusions The management of ICH in China is characterised by high rates of use of intravenous haemodiluting agents, neuroprotectants, and TCM, and of antihypertensives for secondary prevention. The controversial efficacy of these therapies, coupled with the current lack of treatments of proven benefit, is a call for action for more outcomes based research in ICH.

  14. Reappraisal of known malaria resistance loci in a large multi-centre study

    Science.gov (United States)

    Rockett, Kirk A.; Clarke, Geraldine M.; Fitzpatrick, Kathryn; Hubbart, Christina; Jeffreys, Anna E.; Rowlands, Kate; Craik, Rachel; Jallow, Muminatou; Conway, David J.; Bojang, Kalifa A.; Pinder, Margaret; Usen, Stanley; Sisay-Joof, Fatoumatta; Sirugo, Giorgio; Toure, Ousmane; Thera, Mahamadou A.; Konate, Salimata; Sissoko, Sibiry; Niangaly, Amadou; Poudiougou, Belco; Mangano, Valentina D.; Bougouma, Edith C.; Sirima, Sodiomon B.; Modiano, David; Amenga-Etego, Lucas N.; Ghansah, Anita; Koram, Kwadwo A.; Wilson, Michael D.; Enimil, Anthony; Evans, Jennifer; Amodu, Olukemi; Olaniyan, Subulade; Apinjoh, Tobias; Mugri, Regina; Ndi, Andre; Ndila, Carolyne M.; Uyoga, Sophie; Macharia, Alexander; Peshu, Norbert; Williams, Thomas N.; Manjurano, Alphaxard; Riley, Eleanor; Drakeley, Chris; Reyburn, Hugh; Nyirongo, Vysaul; Kachala, David; Molyneux, Malcolm; Dunstan, Sarah J.; Phu, Nguyen Hoan; Ngoc Quyen, Nguyen Thi; Thai, Cao Quang; Hien, Tran Tinh; Manning, Laurens; Laman, Moses; Siba, Peter; Karunajeewa, Harin; Allen, Steve; Allen, Angela; Davis, Timothy M. E.; Michon, Pascal; Mueller, Ivo; Green, Angie; Molloy, Sile; Johnson, Kimberly J.; Kerasidou, Angeliki; Cornelius, Victoria; Hart, Lee; Vanderwal, Aaron; SanJoaquin, Miguel; Band, Gavin; Le, Si Quang; Pirinen, Matti; Sepúlveda, Nuno; Spencer, Chris C.A.; Clark, Taane G.; Agbenyega, Tsiri; Achidi, Eric; Doumbo, Ogobara; Farrar, Jeremy; Marsh, Kevin; Taylor, Terrie; Kwiatkowski, Dominic P.

    2015-01-01

    Many human genetic associations with resistance to malaria have been reported but few have been reliably replicated. We collected data on 11,890 cases of severe malaria due to Plasmodium falciparum and 17,441 controls from 12 locations in Africa, Asia and Oceania. There was strong evidence of association with the HBB, ABO, ATP2B4, G6PD and CD40LG loci but previously reported associations at 22 other loci did not replicate in the multi-centre analysis. The large sample size made it possible to identify authentic genetic effects that are heterogeneous across populations or phenotypes, a striking example being the main African form of G6PD deficiency, which reduced the risk of cerebral malaria but increased the risk of severe malarial anaemia. The finding that G6PD deficiency has opposing effects on different fatal complications of P. falciparum infection indicates that the evolutionary origins of this common human genetic disorder are more complex than previously supposed. PMID:25261933

  15. Effects of unstratified and centre-stratified randomization in multi-centre clinical trials.

    Science.gov (United States)

    Anisimov, Vladimir V

    2011-01-01

    This paper deals with the analysis of randomization effects in multi-centre clinical trials. The two randomization schemes most often used in clinical trials are considered: unstratified and centre-stratified block-permuted randomization. The prediction of the number of patients randomized to different treatment arms in different regions during the recruitment period accounting for the stochastic nature of the recruitment and effects of multiple centres is investigated. A new analytic approach using a Poisson-gamma patient recruitment model (patients arrive at different centres according to Poisson processes with rates sampled from a gamma distributed population) and its further extensions is proposed. Closed-form expressions for corresponding distributions of the predicted number of the patients randomized in different regions are derived. In the case of two treatments, the properties of the total imbalance in the number of patients on treatment arms caused by using centre-stratified randomization are investigated and for a large number of centres a normal approximation of imbalance is proved. The impact of imbalance on the power of the study is considered. It is shown that the loss of statistical power is practically negligible and can be compensated by a minor increase in sample size. The influence of patient dropout is also investigated. The impact of randomization on predicted drug supply overage is discussed.

  16. EXAMINATION OF THE RELATIONSHIP BETWEEN SELF-COMPASSION AND AWARENESS IN INTERPERSONAL RELATION OF POLICE CADETS

    OpenAIRE

    Ruhi YİĞİT

    2012-01-01

    Abstract Main objective of this study is to reveal relationship between levels of awareness of police cadets in terms of interpersonal relations and their self-compassion .Research data has been obtained by using self-insight scale and scale of awareness in interpersonal relations. Research has been made in accordance with general scanning model. Research group consists of police cadets studying in police vocational high school located in Ereğli town of Konya.249 police cadets chosen by ...

  17. Safety of intramuscular influenza vaccine in patients receiving oral anticoagulation therapy: a single blinded multi-centre randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Benítez Mència

    2008-05-01

    Full Text Available Abstract Background Influenza vaccines are recommended for administration by the intramuscular route. However, many physicians use the subcutaneous route for patients receiving an oral anticoagulant because this route is thought to induce fewer hemorrhagic side effects. Our aim is to assess the safety of intramuscular administration of influenza vaccine in patients on oral anticoagulation therapy. Methods Design: Randomised, controlled, single blinded, multi-centre clinical trial. Setting: 4 primary care practices in Barcelona, Spain. Participants: 229 patients on oral anticoagulation therapy eligible for influenza vaccine during the 2003–2004 season. Interventions: intramuscular administration of influenza vaccine in the experimental group (129 patients compared to subcutaneous administration in the control group (100 patients. Primary outcome: change in the circumference of the arm at the site of injection at 24 hours. Secondary outcomes: appearance of local reactions and pain at 24 hours and at 10 days; change in INR (International Normalized Ratio at 24 hours and at 10 days. Analysis was by intention to treat using the 95% confidence intervals of the proportions or mean differences. Results Baseline variables in the two groups were similar. No major side effects or major haemorrhage during the follow-up period were reported. No significant differences were observed in the primary outcome between the two groups. The appearance of local adverse reactions was more frequent in the subcutaneous administration group (37,4% vs. 17,4%, 95% confidence interval of the difference 8,2% to 31,8%. Conclusion This study shows that the intramuscular administration route of influenza vaccine in patients on anticoagulant therapy does not have more side effects than the subcutaneous administration route. Registration number NCT00137579 at clinicaltrials.gov

  18. Multi-centre evaluation of the speed-oligo Mycobacteria assay for differentiation of Mycobacterium spp. in clinical isolates

    OpenAIRE

    Hofmann-Thiel Sabine; Turaev Laziz; Alnour Tarig; Drath Lore; Müllerova Maria; Hoffmann Harald

    2011-01-01

    Abstract Background A new DNA line probe assay (Speed-oligo Mycobacteria, Vircell) has been launched for rapid differentiation of Mycobacterium spp. from cultures. Compared to other line-probe assays, Speed-oligo Mycobacteria covers a relatively limited spectrum of species but uses a simpler and faster dip-stick technique. The present multi-centre, multi-country study aimed at evaluating the utility and usability of Speed-oligo Mycobacteria in routine mycobacteriology diagnostics. Results fro...

  19. 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.

  20. The Impact of a Visual Imagery Intervention on Army ROTC Cadets' Marksmanship Performance and Flow Experiences

    Science.gov (United States)

    Rakes, Edward Lee

    2012-01-01

    This investigation used an experimental design to examine how a visual imagery intervention and two levels of challenge would affect the flow experiences and performance of cadets engaged in Army ROTC marksmanship training. I employed MANCOVA analyses, with gender and prior marksmanship training experience as covariates, to assess cadets' (n =…

  1. 46 CFR 12.25-25 - Members of Merchant Marine Cadet Corps.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 1 2010-10-01 2010-10-01 false Members of Merchant Marine Cadet Corps. 12.25-25 Section 12.25-25 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY MERCHANT MARINE OFFICERS AND SEAMEN... Member of the Engine Department § 12.25-25 Members of Merchant Marine Cadet Corps. No ratings other...

  2. Evaluating Cadet Leadership Positions at the U.S. Air Force Academy

    Science.gov (United States)

    Didier, Jeremy M.

    2012-01-01

    The U.S. Air Force relies on effective leadership to complete its mission. The U.S. Air Force Academy exists to develop leaders of character for the Air Force through a four-year program. Part of this program involves cadets participating in leadership positions. By exploring nine types of cadet leadership positions, this dissertation aims to…

  3. A controlled multi-centre study of herbal versus synthetic secretolytic drugs for acute bronchitis.

    Science.gov (United States)

    Ernst, E; März, R; Sieder, C

    1997-12-01

    Herbal expectorants and secretolytic drugs hold a sizeable share of the European market. Therefore it is essential to test their clinical effectiveness and safety. The aim of the present study was to compare the herbal medication Bronchipret(®) with various other pharmacotherapeutical options for acute bronchitis. The study was designed as a matched-pair comparison of 7783 patients. Clinical outcomes of bronchitis and adverse reactions were documented. The data were evaluated by comparing the treatment success of the test medication and 3 control groups using ordinal regression. The results suggest that clinical effectiveness of Bronchipret(®) was not less than with synthetic drugs. There was a tendency for better results with Bronchipret(®), particularly in the treatment of adults. Similar results were obtained with respect to adverse reactions. Particularly in the adult sub-group, these were markedly less with herbals as compared to synthetic drugs. These findings imply that a risk/benefit evaluation would favour Bronchipret(®) over synthetic drugs for acute bronchitis. Their interpretation is limited through the fact that this study could not be randomised nor blinded. The results therefore require confirmation through randomised, double-blind trials.

  4. 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

  5. Cardiac phantom measurement validating the methodology for a cardiac multi-centre trial with positron emission tomography.

    Science.gov (United States)

    Nuyts, Johan; Mortelmans, Luc; Van de Werf, Frans; Djian, Jacques; Sambuceti, Gianmario; Schwaiger, Marcus; Touboul, Paul; Maes, Alex

    2002-12-01

    In an ongoing international multi-centre trial, positron emission tomography (PET) is being used to evaluate the effect of a new P-selectin antagonist on the infarct size in patients with acute myocardial infarction, treated with thrombolysis. Although it is possible to correct for site-dependent factors, it is desirable to reduce these factors to a minimum. Therefore, acquisition and reconstruction protocols have been defined that can be closely followed by all participating centres. The resulting reconstructed images are transferred to the core centre for central processing with semi-automatic software. This paper reports on the multi-centre phantom experiment that was carried out to assess the inter-centre reproducibility of defect size determination with this protocol. Also, the spatial resolution of the short axis slices was examined. In addition, the analysis procedure was applied to normal PET studies to evaluate the specificity of perfusion defect detection. The transmural cold defect in the phantom occupied 14.8% of the left ventricular area. The automated analysis was applied to the phantom measurements from the 14 participating PET cameras. It yielded an accurate estimate of 15.1% with a standard deviation of 0.6%, indicating excellent reproducibility. The spatial resolution in the short axis slices was similar for all PET systems: 9.6+/-0.8 mm. The same procedure produced a defect size of zero in the studies of normal volunteers. This study indicates that cardiac studies from multiple PET systems can be pooled for statistical analysis.

  6. Cardiac phantom measurement validating the methodology for a cardiac multi-centre trial with positron emission tomography

    Energy Technology Data Exchange (ETDEWEB)

    Nuyts, Johan; Mortelmans, Luc; Maes, Alex [Nuclear Medicine, UZ Gasthuisberg, K.U. Leuven, Herestraat 49, 3000 Leuven (Belgium); Van de Werf, Frans [Cardiology, UZ Gasthuisberg, K.U. Leuven, Leuven (Belgium); Djian, Jacques [Wyeth Research, Paris la Defense Cedex (France); Sambuceti, Gianmario [Instituto di Fisiologia Clinica CNR, Pisa (Italy); Schwaiger, Marcus [Nuklearmedizinische Klinik und Poliklinik, TU Muenchen, Muenchen (Germany); Touboul, Paul [Hopital Cardio-Vasculaire et Pneumologique, Lyon (France)

    2002-12-01

    In an ongoing international multi-centre trial, positron emission tomography (PET) is being used to evaluate the effect of a new P-selectin antagonist on the infarct size in patients with acute myocardial infarction, treated with thrombolysis. Although it is possible to correct for site-dependent factors, it is desirable to reduce these factors to a minimum. Therefore, acquisition and reconstruction protocols have been defined that can be closely followed by all participating centres. The resulting reconstructed images are transferred to the core centre for central processing with semi-automatic software. This paper reports on the multi-centre phantom experiment that was carried out to assess the inter-centre reproducibility of defect size determination with this protocol. Also, the spatial resolution of the short axis slices was examined. In addition, the analysis procedure was applied to normal PET studies to evaluate the specificity of perfusion defect detection. The transmural cold defect in the phantom occupied 14.8% of the left ventricular area. The automated analysis was applied to the phantom measurements from the 14 participating PET cameras. It yielded an accurate estimate of 15.1% with a standard deviation of 0.6%, indicating excellent reproducibility. The spatial resolution in the short axis slices was similar for all PET systems: 9.6{+-}0.8 mm. The same procedure produced a defect size of zero in the studies of normal volunteers. This study indicates that cardiac studies from multiple PET systems can be pooled for statistical analysis. (orig.)

  7. Virginia Tech Corps of Cadets alumnus Timothy Dillera named Hokie Hero

    OpenAIRE

    Cox, Carrie

    2009-01-01

    Corps of Cadets alumnus Capt. Timothy Dillera, United States Air Force, who received a degree in chemistry from the College of Science in 2003 has been selected as the Hokie Hero for the Virginia Tech versus Boston College football game.

  8. To the Issue on the History of the Cadet Corps in Tiflis

    Directory of Open Access Journals (Sweden)

    Mamuka Gogitidze

    2016-06-01

    Full Text Available The article discusses the issue of organizing in Tiflis the cadet corps. The Tiflis cadet corps was founded in 1882 year on the basis of the military school that existed in Tbilisi since 1875 year. In 1827, the officers and officials who served in the Caucasus, presented a petition to Nicholas I on the establishment in the city of Tiflis cadet corps in 150 children. The authors note that a serious problem to a certain extent, affect the quality of teaching cadets, the housing problem. Housing in Tiflis at that time very little was built. It was very difficult to find an apartment in the city on the take-out money for these purposes. The only solution to this problem was to increase salaries to pay for housing. This was done by Layminga recommendations.

  9. Changes of general fitness and muscle properties following police cadet training

    OpenAIRE

    Wu, Yi-Ning; Hallbourg, Keith W.; Collins, Sean M.

    2015-01-01

    [Purpose] This study was performed to examine the relationship between physical performance and muscle properties during police cadet training. The study’s hypothesis was that improved physical performance brought about by training, would in turn cause a reduction in muscle flexibility. [Subjects and Methods] Fifty-nine police cadets were included in this study. Standard fitness tests and quantitative assessments of muscular biomechanical properties were conducted before, during and after the...

  10. CHANGES IN PHYSIOLOGICAL PARAMETERS IN CADET WRESTLERS FOLLOWING A 4-WEEK GENERAL PREPARATION PHASE

    Directory of Open Access Journals (Sweden)

    Bahman Mirzaei

    2011-04-01

    Full Text Available The purpose of this study was to investigate the changes in physiological parameters in cadet wrestlers following a 4-week general preparation phase of training. The physiological parameters included cardiovascular endurance, muscular endurance, speed, agility, flexibility, anaerobic power and body composition. In experiment took part 15 cadet wrestles at the age of 15 years. The testing was conducted twice, before and after the 4-week training period.

  11. Validity of Bioelectrical Impedance Analysis to Estimation Fat-Free Mass in the Army Cadets

    OpenAIRE

    Langer, Raquel D.; Borges, Juliano H.; Pascoa, Mauro A.; Cirolini, Vagner X.; Gil Guerra-Júnior; Ezequiel M. Gonçalves

    2016-01-01

    Background: Bioelectrical Impedance Analysis (BIA) is a fast, practical, non-invasive, and frequently used method for fat-free mass (FFM) estimation. The aims of this study were to validate predictive equations of BIA to FFM estimation in Army cadets and to develop and validate a specific BIA equation for this population. Methods: A total of 396 males, Brazilian Army cadets, aged 17–24 years were included. The study used eight published predictive BIA equations, a specific equation in FFM est...

  12. Recruiting Hard-to-Reach Subjects for Exercise Interventions: A Multi-Centre and Multi-Stage Approach Targeting General Practitioners and Their Community-Dwelling and Mobility-Limited Patients

    Directory of Open Access Journals (Sweden)

    Michael Brach

    2013-12-01

    Full Text Available The general practitioner (GP’s practice appears to be an ideal venue for recruiting community-dwelling older adults with limited mobility. This study (Current Controlled Trials ISRCTN17727272 aimed at evaluating the recruiting process used for a multi-centre exercise intervention (HOMEfit. Each of six steps resulted in an absolute number of patients (N1–N6. Sex and age (for N4–N6 and reasons for dropping out were assessed. Patient database screening (N1–N3 at 15 GP practices yielded N1 = 5,990 patients aged 70 and above who had visited their GP within the past 6 months, N2 = 5,467 after exclusion of institutionalised patients, N3 = 1,545 patients eligible. Using a pre-defined limitation algorithm in order to conserve the practices’ resources resulted in N4 = 1,214 patients (80.3 ± 5.6 years, 68% female, who were then officially invited to the final assessment of eligibility at the GP’s practice. N5 = 434 patients (79.5 ± 5.4 years, 69% female attended the practice screening (n = 13 of whom had not received an official invitation. Finally, N6 = 209 (79.8 ± 5.2 years, 74% female were randomised after they were judged eligible and had given their written informed consent to participate in the randomised controlled trial (overall recruitment rate: 4.4%. The general strategy of utilising a GP’s practice to recruit the target group proved beneficial. The data and experiences presented here can help planners of future exercise-intervention studies.

  13. Mass sports of students and cadets which server military contract in positions of officers

    Directory of Open Access Journals (Sweden)

    Anastasia Bondar

    2015-12-01

    Full Text Available Purpose: study of features of organization of mass sports of students and cadets which server military contract in positions of officers. Material and Methods: analysis of literary sources and documents, analysis of the systems, questioning (questionnaire, methods of the mathematical processing of data. In a questionnaire 97 respondents – 29 cadets of a 5 course and 68 students of 4 courses of military-legal faculty of the Yaroslav Mudryi National law university. Results: 69% cadets and only 35% students are engaged in the different types of motive activity in free time, here 48% cadets and 43% students elect the playing types of sport (football, volley-ball, basket-ball, 65,5% cadets and 48,5% students go in for sports for self-perfection and self-realization, here 45% cadets and 32% students plan necessarily to prolong to be engaged in the select type of sport upon termination of studies in higher educational establishment. Conclusions: the Study 4th Year Students And Students Of The 5th Year Of Military Faculty Of Law Has Shown That The Students Serious About Their Chosen Profession And Understand The Importance Of Physical Fitness In A Future Service, They Are Able To Objectively Assess The Level Of Their Physical Readiness And Are Ready For Further Self-Improvement

  14. Modified Uvulopalatopharyngoplasty and Coblation Channeling of the Tongue for Obstructive Sleep Apnea: A Multi-Centre Australian Trial

    Science.gov (United States)

    MacKay, Stuart G.; Carney, A. Simon; Woods, Charmaine; Antic, Nick; McEvoy, R. Doug; Chia, Michael; Sands, Terry; Jones, Andrew; Hobson, Jonathan; Robinson, Samuel

    2013-01-01

    Study Objectives: To investigate the surgical outcomes and efficacy of modified uvulopalatopharyngoplasty (mod UPPP) and Coblation channelling of the tongue (CCT) as a treatment for obstructive sleep apnea (OSA). Methods: Adult patients with simple snoring or obstructive sleep apnea were treated with combined modified UPPP, bilateral tonsillectomy, and CCT (N = 48). Full polysomnography was performed preoperatively and 3 months postoperatively. Postoperative clinical assessment, sleep questionnaires, and patient demographics including body mass index were compared to preoperative data. All polysomnograms were re-scored to AASM recommended criteria by 2 sleep professionals. Results: The preoperative AHI (median and interquartile range) of 23.1 (10.4 to 36.6) was lowered to a postoperative AHI of 5.6 (1.9 to 10.4) (p coblation channeling of the tongue for obstructive sleep apnea: a multi-centre australian trial. J Clin Sleep Med 2013;9(2):117–124. PMID:23372463

  15. The Department of Health's research governance framework remains an impediment to multi-centre studies:findings from a national descriptive study

    OpenAIRE

    Kielmann, Tara; Tierney, Alison; Porteous, Rosemary; Huby, Guro; Sheikh, Aziz; Pinnock, Hilary

    2007-01-01

    Objective We describe our experience of using the standard application form, designed to streamline applications for multi-centre research, to seek approval from all primary care organizations (PCOs) in England and Wales to undertake a single telephone interview with a health service manager.

  16. Species distribution and susceptibility profile to fluconazole, voriconazole and MXP-4509 of 551 clinical yeast isolates from a Romanian multi-centre study

    NARCIS (Netherlands)

    Minea, B; Nastasa, V; Moraru, R F; Kolecka, A; Flonta, M M; Marincu, I; Man, A; Toma, F; Lupse, M; Doroftei, B; Marangoci, N; Pinteala, M; Boekhout, T; Mares, M

    2015-01-01

    This is the first multi-centre study regarding yeast infections in Romania. The aim was to determine the aetiological spectrum and susceptibility pattern to fluconazole, voriconazole and the novel compound MXP-4509. The 551 isolates were identified using routine laboratory methods, matrix-assisted l

  17. A multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f® in women undergoing ovarian stimulation for IVF

    DEFF Research Database (Denmark)

    Rettenbacher, M; Andersen, A N; Garcia-Velasco, J A;

    2015-01-01

    Bemfola (follitropin alfa) (Finox AG, Switzerland), a new recombinant FSH, has a comparable pharmacological profile to that of Gonal-f (Merck Serono, Germany), the current standard for ovarian stimulation. A randomized, multi-centre, Phase 3 study in women undergoing IVF or intracytoplasmic sperm...

  18. Changes of general fitness and muscle properties following police cadet training.

    Science.gov (United States)

    Wu, Yi-Ning; Hallbourg, Keith W; Collins, Sean M

    2015-09-01

    [Purpose] This study was performed to examine the relationship between physical performance and muscle properties during police cadet training. The study's hypothesis was that improved physical performance brought about by training, would in turn cause a reduction in muscle flexibility. [Subjects and Methods] Fifty-nine police cadets were included in this study. Standard fitness tests and quantitative assessments of muscular biomechanical properties were conducted before, during and after the 20-week cadet training. [Results] General fitness had improved at the end of the police cadet training. There was no significant decrease in muscle flexibility as measured by the Sit-and-Reach test. However, muscle compliance of the non-dominant leg measured by the relaxation coefficient had decreased at the end of the police cadet training. [Conclusion] The increased sit-and-reach distance could be due in part to strengthening of the abdominal muscles. On the other hand, the biomechanical test, which was specific to muscle extensibility, showed a reduction in the relaxation coefficient of the non-dominant leg. Our data suggests that changes in muscle compliance as a result of lower extremity training should be considered. This data may be useful in the design of a training protocol that prevents the potential injuries caused by reduced muscle flexibility. PMID:26504293

  19. Physical Fitness of Police Academy Cadets: Baseline Characteristics and Changes During a 16-Week Academy.

    Science.gov (United States)

    Crawley, Amy A; Sherman, Ross A; Crawley, William R; Cosio-Lima, Ludmila M

    2016-05-01

    Police academies traditionally emphasize the importance of being physically fit. The purpose of this research was to determine cadet baseline physical fitness characteristics and assess effectiveness of a 16-week training program. Sixty-eight cadets (61 men, 7 women) volunteered to have baseline physical fitness characteristics assessed, and 55 cadets (49 men, 6 women) completed further testing at weeks 8 and 16. The testing comprised hand grip (strength), arm crank (upper-body power), 30 seconds Wingate (lower body power), sum of skinfolds and percentage body fat (body composition), 40-yard dash (sprint speed), 1 repetition maximum bench press (strength), T-test (agility), and sit-and-reach (flexibility). In addition, cadets completed standardized state testing (push-ups, sit-ups, vertical jump, and half-mile shuttle run). The training program consisted of 1 hour sessions, 3 d·wk, including aerobic, plyometrics, body weight, and resistance exercise. Significant changes were found in agility (p change across the second half of the program (weeks 8-16). A number of individual parameters of physical fitness showed evidence of improvement in the first 8 weeks, whereas none of the variables showed significant improvement in the second 8 weeks. This suggests modifications could be made to increase overall effectiveness of cadet physical training specifically after the 8-week mark. PMID:26466133

  20. Smart Warriors: A Rationale for Educating Air Force Academy Cadets in the History of Science, Technology, and Warfare.

    Science.gov (United States)

    Astore, William J.

    2003-01-01

    Identifies enhancing the judgments of cadets through education at a military institution like the United States Air Force Academy (USAFA) as a crucial pedagogical issue facing instructors of History of Science and Technology (HST). Discusses the experience of helping cadets to meet such challenges in learning HST in the context of professional…

  1. Preoperative short-course radiotherapy versus combined radiochemotherapy in locally advanced rectal cancer: a multi-centre prospectively randomised study of the Berlin Cancer Society

    Directory of Open Access Journals (Sweden)

    Loy Volker

    2009-02-01

    Full Text Available Abstract Background The additional use of radiotherapy has changed the treatment of locally advanced rectal cancer (LARC dramatically. But a major achievement has been the development of total mesorectal excision (TME as a surgical standard and the recognition that the surgeon is the predominant prognostic factor. The benefit of preoperative hypofractionated radiotherapy (SCRT; five fractions each of 5 Gy, initially established by the Swedish Rectal Cancer Trial, has been demonstrated in conjunction with TME by the Dutch Colorectal Cancer Group. The concept of combined neoadjuvant radiochemotherapy (conventional radiation of about 50 Gy with chemotherapy has not been compared over surgery alone with TME. However, the German Rectal Cancer Study Group recently demonstrated that preoperative radiochemotherapy (RCT was better than postoperative radiochemotherapy in terms of local control. Methods and design Patients with histological proven rectal cancer staged T2N+ or T3 are randomized to receive either SCRT (25 Gy in five fractions of 5 Gy plus TME-surgery within 5 days or RCT (50.4 Gy in 28 fractions of 1.8 Gy, continuous infusion 5-fluorouracil plus TME-surgery 4–6 weeks later. All patients receive adjuvant chemotherapy (12 weeks continuous infusional 5-FU and are followed up for 5 years. TME-quality is independently documented by the surgeon and the pathologist. Hypothesis of the study is that RCT is superior to SCRT in terms of local recurrence after five years. Secondary endpoints are overall survival, disease-free survival, complete resection rate (R0 resection, rate of sphincter saving resection, acute and late toxicity (radiation related side effects, and quality of life (including long term bowel function. Discussion Similar long-term survival, local control and late morbidity have been reported for both concepts of preoperative therapy in non-comparative studies. In addition to other ongoing (and recently published comparative trials we include a larger number of patients for adequate power, apply quality-controlled TME and try to avoid the adjuvant treatment bias by mandatory adjuvant chemotherapy in both groups. Further more, stratification of the initially planned surgical procedure and sphincter-preservation will generate valid evidence whether RCT will allow a less aggressive (sphincter saving surgical approach.

  2. A multi-centre, randomised controlled trial of the effectiveness of PDSAFE to prevent falls among people with Parkinson's: study protocol

    OpenAIRE

    Goodwin, Victoria A; Pickering, Ruth; Ballinger, Claire; Roberts, Helen; McIntosh, Emma; Lamb, Sarah; Nieuwboer, Alice; Rochester, Lynn; Ashburn, Ann; PDSAFE Protocol Development Group

    2015-01-01

    Background Falls amongst people with Parkinson’s (PwP) result in significant disability and reduced quality of life. There is emerging evidence that exercise-based and physiotherapeutic interventions are of benefit for improving fall risk factors, such as balance. However, the benefit, in terms of preventing falls, is mixed. The development of effective interventions has been identified as the highest research priority for this population. The aim of this trial is to establish the effectivene...

  3. A multi-centre, randomised controlled trial of the effectiveness of PDSAFE to prevent falls among people with Parkinson's: study protocol

    OpenAIRE

    Goodwin, V A; Pickering, R; Ballinger, C; Roberts, H.; McIntosh, E; Lamb, S; Nieuwboer, A.; Rochester, L.; Ashburn, A.

    2015-01-01

    Background: falls amongst people with Parkinson’s (PwP) result in significant disability and reduced quality of life. There is emerging evidence that exercise-based and physiotherapeutic interventions are of benefit for improving fall risk factors, such as balance. However, the benefit, in terms of preventing falls, is mixed. The development of effective interventions has been identified as the highest research priority for this population. The aim of this trial is to establish the effect...

  4. 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...

  5. Program of rehabilitative exercise and education to avert vascular events after non-disabling stroke or transient ischemic attack (PREVENT Trial: a multi-centred, randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Thompson Kara

    2010-12-01

    Full Text Available Abstract Background Despite lack of outward signs, most individuals after non-disabling stroke (NDS and transient ischemic attack (TIA have significant cardiovascular and cerebrovascular disease and are at high risk of a major stroke, hospitalization for other vascular events, or death. Most have multiple modifiable risk factors (e.g., hypertension, physical inactivity, hyperlipidaemia, diabetes, tobacco consumption, psychological stress. In addition, accelerated rates of depression, cognitive decline, and poor quality of sleep have been reported following TIA, which correlate with poor functional outcomes and reduced quality of life. Thus, NSD and TIA are important warning signs that should not be overlooked. The challenge is not unlike that facing other 'silent' conditions - to identify a model of care that is effective in changing people's current behaviors in order to avert further morbidity. Methods/Design A single blind, randomized controlled trial will be conducted at two sites to compare the effectiveness of a program of rehabilitative exercise and education versus usual care in modifying vascular risk factors in adults after NDS/TIA. 250 adults within 90 days of being diagnosed with NDS/TIA will be randomly allocated to a 12-week program of exercise and education (PREVENT or to an outpatient clinic assessment and discussion of secondary prevention recommendations with return clinic visits as indicated (USUAL CARE. Primary outcome measures will include blood pressure, waist circumference, 12-hour fasting lipid profile, and 12-hour fasting glucose/hemoglobin A1c. Secondary measures will include exercise capacity, walking endurance, physical activity, cognitive function, depression, goal attainment and health-related quality of life. Outcome assessment will be conducted at baseline, post-intervention, and 6- and 12-month follow-ups. Direct health care costs incurred over one year by PREVENT versus USUAL CARE participants will also be compared. Ethical approval for the trial has been obtained from the relevant Human Research Ethics Boards. Discussion Whether timely delivery of an adapted cardiac rehabilitation model is effective in attaining and maintaining vascular risk reduction targets in adults after NDS/TIA is not yet known. We anticipate that the findings of this trial will make a meaningful contribution to the knowledge base regarding secondary stroke prevention. Trial registration This trial is registered with the Clinical Trials.gov Registry (NCT00885456.

  6. A Randomised Multi-centre Study to Compare the Long-term Performance of the Future Hip to 3 Other Implants in Primary Total Hip Replacement

    Science.gov (United States)

    2011-09-01

    Osteoarthritis; Post-traumatic Arthritis; Collagen Disorders; Avascular Necrosis; Traumatic Femoral Fractures; Nonunion of Femoral Fractures; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis; Perthes Disease

  7. Use of platelet rich plasma to treat plantar fasciitis: design of a multi centre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Peerbooms Joost C

    2010-04-01

    Full Text Available Abstract Background If conservative treatment for chronic plantar fasciitis fails, often a corticosteroid injection is given. Corticosteroid injection gives temporarily pain reduction, but no healing. Blood platelets initiate the natural healing rate. GPS® gives an eightfold concentrate platelets of patients own blood. Injection of these platelets in the attachment of the fascia to the os calcis might induce a healing rate. Methods and design A randomized controlled multi centre trial will be performed. The study population consists of 120 patients of 18 years and older. Patients with chronic plantar fasciitis will be allocated randomly to have a steroid injection or an autologous platelet concentrate injections. Data will be collected before the procedure, 4,8,12,26 weeks and 1 year after the procedure. The main outcome measures of this study are pain and function measured with questionnaires. Conclusion Recent literature show positive effects for the treatment of tendinosis with autologous platelet injections. The forthcoming trial will compare treatment for chronic plantar fasciitis with a steroid injection versus an autologous platelet injection. Our results will be published as soon as they become available. Trial Registration Trial registration number: http://www.clinicaltrials.gov NCT00758641.

  8. A multi-centre, double-blind study of serrapeptase versus placebo in post-antrotomy buccal swelling.

    Science.gov (United States)

    Tachibana, M; Mizukoshi, O; Harada, Y; Kawamoto, K; Nakai, Y

    1984-01-01

    A multi-centre, double-blind, placebo-controlled trial was carried out to investigate the clinical efficacy of the anti-inflammatory enzyme serrapeptase in a total of 174 patients who underwent Caldwell-Luc antrotomy for chronic empyema. Eighty-eight patients received 10 mg serrapeptase 3 times on the day before operation, once on the night of the operation and 3 times daily for 5 days after operation; the other 86 received placebo. Changes in buccal swelling after operation were observed as a parameter of the response to treatment. The degree of swelling in the serrapeptase-treated patients was significantly less than that in the placebo-treated patients at every point of observation after operation up to the 5th day (p less than 0.01 to p less than 0.05). Maximal swelling throughout all the post-operative points of observation was also significantly smaller in size in the serrapeptase-treated group than in the placebo-treated group. No side-effects were reported.

  9. Creating probabilistic maps of the face network in the adolescent brain: A multi-centre functional MRI study

    International Nuclear Information System (INIS)

    Large-scale magnetic resonance (MR) studies of the human brain offer unique opportunities for identifying genetic and environmental factors shaping the human brain. Here, we describe a dataset collected in the context of a multi-centre study of the adolescent brain, namely the IMAGEN Study. We focus on one of the functional paradigms included in the project to probe the brain network underlying processing of ambiguous and angry faces. Using functional MR (fMRI) data collected in 1,110 adolescents, we constructed probabilistic maps of the neural network engaged consistently while viewing the ambiguous or angry faces; 21 brain regions responding to faces with high probability were identified. We were also able to address several methodological issues, including the minimal sample size yielding a stable location of a test region, namely the fusiform face area (FFA), as well as the effect of acquisition site (eight sites) and scanner (four manufacturers) on the location and magnitude of the fMRI response to faces in the FFA. Finally, we provided a comparison between male and female adolescents in terms of the effect sizes of sex differences in brain response to the ambiguous and angry faces in the 21 regions of interest. Overall, we found a stronger neural response to the ambiguous faces in several cortical regions, including the fusiform face area, in female (vs. male) adolescents, and a slightly stronger response to the angry faces in the amygdala of male (vs. female) adolescents. (authors)

  10. Comparative analysis of physical fitness of students and cadets NUCPU to perform professional duties

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    Vitaly Kolokolov

    2014-12-01

    Full Text Available Purpose: to determine differences in physical training of cadets and students I rate faculties "Civil Defense", "Fire", "Technogenic and Environmental". Material and Methods: the study was conducted on the basis of educational and sports complex of the National University of Civil Defence of Ukraine. Students studied 80 boys and 80 students-boys. Results: a comparative analysis of the physical fitness of students and students. The results of testing Conclusions: set the difference in terms of performance but only if the three exercises: pull a translated, long jump, shuttle run, which allows you to optimize the physical training of cadets and students considering their future careers.

  11. Methods of data collection and analysis for the economic evaluation alongside a national, multi-centre trial in the UK: Conventional ventilation or ECMO for Severe Adult Respiratory Failure (CESAR

    Directory of Open Access Journals (Sweden)

    Elbourne Diana R

    2008-04-01

    Full Text Available Abstract Background Extracorporeal Membrane Oxygenation (ECMO is a technology used in treatment of patients with severe but potentially reversible respiratory failure. A multi-centre randomised controlled trial (CESAR was funded in the UK to compare care including ECMO with conventional intensive care management. The protocol and funding for the CESAR trial included plans for economic data collection and analysis. Given the high cost of treatment, ECMO is considered an expensive technology for many funding systems. However, conventional treatment for severe respiratory failure is also one of the more costly forms of care in any health system. Methods/Design The objectives of the economic evaluation are to compare the costs of a policy of referral for ECMO with those of conventional treatment; to assess cost-effectiveness and the cost-utility at 6 months follow-up; and to assess the cost-utility over a predicted lifetime. Resources used by patients in the trial are identified. Resource use data are collected from clinical report forms and through follow up interviews with patients. Unit costs of hospital intensive care resources are based on parallel research on cost functions in UK NHS intensive care units. Other unit costs are based on published NHS tariffs. Cost effectiveness analysis uses the outcome: survival without severe disability. Cost utility analysis is based on quality adjusted life years gained based on the Euroqol EQ-5D at 6 months. Sensitivity analysis is planned to vary assumptions about transport costs and method of costing intensive care. Uncertainty will also be expressed in analysis of individual patient data. Probabilities of cost effectiveness given different funding thresholds will be estimated. Discussion In our view it is important to record our methods in detail and present them before publication of the results of the trial so that a record of detail not normally found in the final trial reports can be made available

  12. A multi-centre prospective development study evaluating focal therapy using high intensity focused ultrasound for localised prostate cancer: The INDEX study.

    OpenAIRE

    Dickinson, L.; Ahmed, H. U.; Kirkham, A; Allen, C.; Freeman, A; Barber, J; Hindley, R; Leslie, T.; Ogden, C.; Persad, R; Winkler, M.H.; Emberton, M; on behalf of the INDEX Study Group

    2013-01-01

    Introduction Focal therapy offers the possibility of cancer control, without the side effect profile of radical therapies. Early single centre prospective development studies using high intensity focused ultrasound (HIFU) have demonstrated encouraging genitourinary functional preservation and short-term cancer control. Large multi-centre trials are required to evaluate medium-term cancer control and reproduce functional recovery. We describe the study design of an investigator-led UK multi-ce...

  13. Is there a case for establishing a multi-Centre Masters Programme in Public Health across Kent, Surrey and Sussex? A feasibility study

    OpenAIRE

    Cornish, Yvonne

    2004-01-01

    This study, which was commissioned by the Kent, Surrey and Sussex Workforce Development Confederation, assesses the feasibility of establishing a multi-centred modular masters programme in public health. The purpose of such a programme, would be to support the development of the public health workforce within the South East of the Region, to ensure that it is ‘fit for purpose’ in terms of delivering the current public health agenda.

  14. Validity and reliability of the braden scale and the influence of other risk factors: a multi-centre prospective study.

    Science.gov (United States)

    Halfens, R J; Van Achterberg, T; Bal, R M

    2000-08-01

    The Braden scale is one of the most intensively studied risk assessment scales used in identifying the risk of developing pressure sores. However, not all studies show that the sensitivity and specificity of this scale is sufficient. This study, therefore, investigated whether adding new risk factors can enhance the sensitivity and specificity of the Braden scale. The Braden scale was tested in a prospective multi-centre design. The nurses of 11 wards filled in the Braden scale every 5 days for each patient who was admitted without pressure sores and who had a probable stay of at least 10 days. Based on a literature study and in-depth interviews with experts, the Braden scale was extended by the risk factor blood circulation. In addition, other risk factors, which are more or less stable patient characteristics, were measured during the admission of the patient. Independent research assistants measured the presence of pressure sores twice a week. As the external criterion for the risk of developing pressure sores, the presence of pressure sores and/or the use of preventive activities was used. Results showed that the original Braden scale was a reliable instrument and that the sensitivity and specificity was sufficient. However, reformulating the factors moisture and nutrition, and adding the risk factor age could enhance the sensitivity and specificity. Furthermore, results showed that the factors sensory perception, and friction and shear were especially important risk factors for the Braden scale. In fact, using only the factors sensory perception, friction and shear, moisture (a reformulated factor) and age give the highest explained variance of the risk of developing pressure sores. The added risk factor blood circulation, did not enhance the sensitivity and specificity of the original Braden scale. Suggestions are given on how to use risk assessment scales in practice.

  15. A multi-centre cohort study shows no association between experienced violence and labour dystocia in nulliparous women at term

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    Dykes Anna-Karin

    2011-02-01

    Full Text Available Abstract Background Although both labour dystocia and domestic violence during pregnancy are associated with adverse maternal and fetal outcome, evidence in support of a possible association between experiences of domestic violence and labour dystocia is sparse. The aim of this study was to investigate whether self-reported history of violence or experienced violence during pregnancy is associated with increased risk of labour dystocia in nulliparous women at term. Methods A population-based multi-centre cohort study. A self-administrated questionnaire collected at 37 weeks of gestation from nine obstetric departments in Denmark. The total cohort comprised 2652 nulliparous women, among whom 985 (37.1% met the protocol criteria for dystocia. Results Among the total cohort, 940 (35.4% women reported experience of violence, and among these, 66 (2.5% women reported exposure to violence during their first pregnancy. Further, 39.5% (n = 26 of those had never been exposed to violence before. Univariate logistic regression analysis showed no association between history of violence or experienced violence during pregnancy and labour dystocia at term, crude OR 0.91, 95% CI (0.77-1.08, OR 0.90, 95% CI (0.54-1.50, respectively. However, violence exposed women consuming alcoholic beverages during late pregnancy had increased odds of labour dystocia, crude OR 1.45, 95% CI (1.07-1.96. Conclusions Our findings indicate that nulliparous women who have a history of violence or experienced violence during pregnancy do not appear to have a higher risk of labour dystocia at term, according to the definition of labour dystocia in this study. Additional research on this topic would be beneficial, including further evaluation of the criteria for labour dystocia.

  16. Splinting after contracture release for Dupuytren's contracture (SCoRD: protocol of a pragmatic, multi-centre, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Chojnowski Adrian J

    2008-04-01

    Full Text Available Abstract Background Splinting as part of the overall post-surgical management of patients after release of Dupuytren's contracture has been widely reported, though there is variation in practice and criteria for using it. The evidence on its effectiveness is sparse, of poor quality and contradictory with studies reporting negative and positive effects. Methods/Design A multi-centre, pragmatic, randomized, controlled trial is being conducted to evaluate the effect of static night splinting for six months on hand function, range of movement, patient satisfaction and recurrence at 1 year after fasciectomy or dermofasciectomy. Using a centrally administered computer randomization system consented patients will be allocated to one of two groups: i splint group who will be given a static splint at approximately 10 to 14 days after surgery to be worn for 6 months at night time only as well as hand therapy; ii non-splint group, who will receive hand therapy only. The primary outcome measure is the patient-reported Disabilities of the Arm, Hand and Shoulder Questionnaire (DASH. Secondary outcomes are total active flexion and extension of fingers, patient satisfaction and recurrence of contracture. Outcome measures will be collected prior to surgery, 3 months, 6 months and 1 year after surgery. Using the DASH as the primary outcome measure, where a difference of 15 points is considered to be a clinically important difference a total of 51 patients will be needed in each group for a power of 90%. An intention-to-treat analysis will be used. Discussion This pragmatic randomized controlled trial will provide much needed evidence on the clinical effectiveness of post-operative night splinting in patients who have undergone fasciectomy or dermofasciectomy for Dupuytren's contracture of the hand. Trial Registration Current Controlled Trials ISRCTN 57079614

  17. Virginia Tech Corps of Cadets alumnus Patrick Hogeboom named Hokie Hero

    OpenAIRE

    Cox, Carrie

    2009-01-01

    Virginia Tech Corps of Cadets alumnus Maj. Patrick Hogeboom, United States Army, who received a degree in civil engineering from the College of Engineering in 1994 has been selected as the Hokie Hero for the Virginia Tech versus Georgia Tech football game.

  18. Virginia Tech Corps of Cadets alumnus Tom Roberts named Boston College game Hokie Hero

    OpenAIRE

    Cox, Carrie

    2010-01-01

    Virginia Tech Corps of Cadets alumnus retired Col. James Tom Roberts, U.S. Army, who earned a degree in business administration from the Pamplin College of Business in 1962 has been selected as the Hokie Hero for the Virginia Tech versus Boston College game.

  19. Virginia Tech Corps of Cadets alumni Tim Fong, Mike Martinez named Hokie Heroes

    OpenAIRE

    Cox, Carrie

    2009-01-01

    Virginia Tech Corps of Cadets alumni Capt. Tim Fong, United States Army, who received a degree in economics from the College of Science in 2005 and Capt. Mike Martinez, United States Army, who received a degree in chemistry from the College of Science in 2004, have been selected as the Hokie Heroes for the Virginia Tech versus Duke football game.

  20. 5 CFR 831.304 - Service with the Cadet Nurse Corps during World War II.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Service with the Cadet Nurse Corps during World War II. 831.304 Section 831.304 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED... Nurse Corps during World War II. (a) Definitions and special usages. In this section— (1) Basic pay...

  1. Incidence and Characteristics of Traumatic Shoulder Instability in Japanese Military Cadets.

    Science.gov (United States)

    Amako, Masatoshi; Sasao, Hiroshi; Matsuhashi, Yusuke; Yato, Yoshiyuki; Yoshihara, Yasuo; Arino, Hiroshi; Sakurai, Yutaka; Nemoto, Koichi

    2016-06-01

    Little is known regarding the incidence of the shoulder instability in Japan. The aim of this study was to evaluate the incidence of traumatic shoulder instability among Japanese military cadets. A prospective cohort study was performed to capture all traumatic shoulder instability events between 2009 and 2012 among cadets in a military educational academy of the Japan Self Defense Forces. The total number of cadets in the cohort was 5,402 (average age 20.6 years). The incidence of instability events, including dislocation or subluxation, was calculated. Chronicity, demographics of participants, mechanism of injury, and athletic events were also evaluated. The incidence of traumatic dislocation was 4.1/1,000 person-years and that of subluxation was 6.1/1,000 person-years. The incidence of primary dislocation or subluxation was 5.4/1,000 person-years and that of recurrent dislocation or subluxation was 4.7/1,000 person-years. Of first dislocations or subluxations, 92% occurred during sports activities, including after-school sports activities, military training, and gym classes. In conclusion, the overall incidence of shoulder instability events among Japanese military cadets was 10.3/1,000 person-years, and was extremely high. Most shoulder instability events occurred during sports activities, and a program to prevent such injuries during sports activities is necessary for young participants. PMID:27244069

  2. An investigation of the English Language Needs, Motivations, and Attitudes of Saudi Police Cadets

    Directory of Open Access Journals (Sweden)

    Mohammed Nasser Alhuqbani

    2014-03-01

    Full Text Available This study investigated the English language needs, motivations and attitudes of a random sample of 223 police cadets studying at King Fahd Security College in Saudi Arabia. The analysis of the questionnaire results showed that only cadets with degrees in humanities received English instructions. The cadets selected speaking and listening as the most important skills and studying English for security purposes. As regards their motivations, the significant correlation between almost all the instrumental and integrative variables provided evidence to the integration of the two types of motivations which substantiates the importance of both types in English learning.  Statements describing negative attitudes toward the English culture did not statistically correlate with the other statements that constitute the cadets’ positive attitudes toward English learning, which confirmed their positive attitudes toward both English learning and its culture. The significant correlations between the cadets’ English perceived needs and their instrumental motivations supported the argument that ESP learners study English for utilitarian purposes.   Keywords: ESP, needs analysis, attitudes, motivation, Saudi police cadets

  3. Predictores Para la Selección de Cadetes en Instituciones Militares Predictors for the Selection of Cadets in Military Institutions

    Directory of Open Access Journals (Sweden)

    Alejandro Castro Solano

    2005-05-01

    Full Text Available En el marco de una investigación más amplia sobre predictores de éxito en el entrenamiento de cadetes militares argentinos, se presentan dos estudios. El primero analiza seis cohortes de egresados de una institución militar (1997-2003, atendiendo a la variabilidad en el rendimiento en su educación superior, relacionándolo con variables sociodemográficas (educación y ocupación parentales y estatus de pariente de militar. Los resultados indican que los promedios generales de carrera observan una tendencia descendente en el tiempo. El rendimiento militar muestra menor variabilidad, en tanto que los rendimientos académico y militar aparecen ligados al nivel educativo parental. En el segundo estudio se analiza la cohorte de ingresantes 2003, incluyéndose predictores tales como datos biográficos, valores, rasgos de personalidad y motivación. Cinco de las categorías consideradas discriminaban entre los grupos de cadetes con alto y bajo rendimiento: factores cognitivos relacionados con el rendimiento previo, la orientación vocacional y ciertos rasgos de liderazgo. Por otra parte, quienes obtenían calificaciones bajas en su primer año de estudios militares exhibían mayor motivación extrínseca, menor motivación intrínseca, estaban menos orientados al logro y su valor hegemónico era el poder.In the frame of a larger research on predictors of success in trainig of Argentinian military cadets, two studies are introduced. The first one analyzes six cohorts of graduates from a military educative institution (1997-2003, taking into account the variability in the achievement exhibited during their higher education, relating it to demographics variables (parental education and occupation and the status of being a military's relative. Results show academic averages are descending in a period of six years. Military achievement shows less variability, while both academic and military achievement seem to be associated to parental education. The

  4. SU-C-BRD-01: Multi-Centre Collaborative Quality Assurance Program for IMRT Planning and Delivery: Year 3 Results

    Energy Technology Data Exchange (ETDEWEB)

    McNiven, A; Jaffray, D; Letourneau, D [Princess Margaret Cancer Centre and Department of Radiation Oncology, University of Toronto, Toronto, ON (Canada)

    2015-06-15

    Purpose: A multi-centre quality assurance program was developed to enable quality improvement by coupling measurement of intensity modulated radiotherapy (IMRT) planning and delivery performance for site-specific planning exercises with diagnostic testing. The third year of the program specifically assessed the quality of spine stereotactic body radiotherapy (SBRT) planning and delivery amongst the participating centres. Methods: A spine SBRT planning exercise (24 Gy in 2 fractions) was created and completed by participants prior to an on-site visit. The delivery portion of the on-site visit included spine SBRT plan delivery and diagnostic testing, which included portal image acquisition for quantification of phantom positioning error and multi-leaf collimator (MLC) calibration accuracy. The measured dose was compared to that calculated in the treatment planning system (TPS) using 3%/2mm composite analysis and 3%/3mm gamma analysis. Results: Fourteen institutions participated, creating 17 spine SBRT plans (15 VMAT and 2 IMRT). Three different TPS, two beam energies (6 MV and 6 MV FFF), and four MLC designs from two linac vendors were tested. Large variation in total monitor units (MU) per plan (2494–6462 MU) and dose-volume parameters was observed. The maximum point dose in the plans ranged from 116–149% and was dependent upon the TPS used. Pass rates for measured to planned dose comparison ranged from 89.4–100% and 97.3–100% for 3%/2mm and 3%/3mm criteria respectively. The largest measured MLC error did Result in one of the poorer pass rates. No direct correlation between phantom positioning error and pass rates overall. Conclusion: Significant differences were observed in the planning exercise for some plan and dose-volume parameters based on the TPS used. Standard evaluation criteria showed good agreement between planned and measured dose for all participants, however on an individual plan basis, diagnostic tests were able to identify contributing

  5. Multi-centre evaluation of the speed-oligo Mycobacteria assay for differentiation of Mycobacterium spp. in clinical isolates

    Directory of Open Access Journals (Sweden)

    Hofmann-Thiel Sabine

    2011-12-01

    Full Text Available Abstract Background A new DNA line probe assay (Speed-oligo Mycobacteria, Vircell has been launched for rapid differentiation of Mycobacterium spp. from cultures. Compared to other line-probe assays, Speed-oligo Mycobacteria covers a relatively limited spectrum of species but uses a simpler and faster dip-stick technique. The present multi-centre, multi-country study aimed at evaluating the utility and usability of Speed-oligo Mycobacteria in routine mycobacteriology diagnostics. Results from Speed-oligo Myobacteria were compared to those from Genotype CM (HAIN lifescience, Nehren, Germany, another line-probe assay. Methods Speed-oligo Mycobacteria assay was performed in three main steps: 1 DNA extraction from cultured material 2 PCR amplification of the target gene and an internal control and 3 hybridization of the PCR products to specific probes by means of a dip-stick. Results Two hundred forty-two clinical isolates were recovered from consecutive positive mycobacterial cultures at two German (IML Gauting, Bioscientia Ingelheim, one Czech (KLINLAB Prague, and at a Sudanese (Khartoum laboratory. All Mycobacterium species covered by the assay were reliably recognized. The rate of false positive results was 1.2% and concerned only the species M. marinum and M. peregrinum. The identification rate, i.e. the proportion of isolates which was correctly differentiated to the level of species or complex by the assay, differed significantly among laboratories being 94.9%, 90.7%, and 75.0% at the study sites IML Gauting, KLINLAB Prague and Bioscientia Ingelheim, respectively. This difference was caused by different spectra of NTM species encountered by the laboratory centres in daily routine diagnostics. Conclusions Speed-oligo Mycobacteria assay was proved a rapid and easy-to-perform alternative to conventional line-probe assays. The assay showed excellent sensitivity with regard to identification of genus Mycobacterium and species/complexes covered by

  6. SU-C-BRD-01: Multi-Centre Collaborative Quality Assurance Program for IMRT Planning and Delivery: Year 3 Results

    International Nuclear Information System (INIS)

    Purpose: A multi-centre quality assurance program was developed to enable quality improvement by coupling measurement of intensity modulated radiotherapy (IMRT) planning and delivery performance for site-specific planning exercises with diagnostic testing. The third year of the program specifically assessed the quality of spine stereotactic body radiotherapy (SBRT) planning and delivery amongst the participating centres. Methods: A spine SBRT planning exercise (24 Gy in 2 fractions) was created and completed by participants prior to an on-site visit. The delivery portion of the on-site visit included spine SBRT plan delivery and diagnostic testing, which included portal image acquisition for quantification of phantom positioning error and multi-leaf collimator (MLC) calibration accuracy. The measured dose was compared to that calculated in the treatment planning system (TPS) using 3%/2mm composite analysis and 3%/3mm gamma analysis. Results: Fourteen institutions participated, creating 17 spine SBRT plans (15 VMAT and 2 IMRT). Three different TPS, two beam energies (6 MV and 6 MV FFF), and four MLC designs from two linac vendors were tested. Large variation in total monitor units (MU) per plan (2494–6462 MU) and dose-volume parameters was observed. The maximum point dose in the plans ranged from 116–149% and was dependent upon the TPS used. Pass rates for measured to planned dose comparison ranged from 89.4–100% and 97.3–100% for 3%/2mm and 3%/3mm criteria respectively. The largest measured MLC error did Result in one of the poorer pass rates. No direct correlation between phantom positioning error and pass rates overall. Conclusion: Significant differences were observed in the planning exercise for some plan and dose-volume parameters based on the TPS used. Standard evaluation criteria showed good agreement between planned and measured dose for all participants, however on an individual plan basis, diagnostic tests were able to identify contributing

  7. The impact of a visual imagery intervention on Army ROTC cadetsâ marksmanship performance and flow experiences

    OpenAIRE

    Rakes, Edward Lee

    2012-01-01

    This investigation used an experimental design to examine how a visual imagery intervention and two levels of challenge would affect the flow experiences and performance of cadets engaged in Army ROTC marksmanship training. I employed MANCOVA analyses, with gender and prior marksmanship training experience as covariates, to assess cadetsâ (n = 127) marksmanship performance and flow experiences. Findings revealed that the use of visual imagery did not positively enhance flow and improve perf...

  8. Physical Fitness of Police Academy Cadets: Baseline Characteristics and Changes During a 16-Week Academy

    Science.gov (United States)

    Sherman, Ross A.; Crawley, William R.; Cosio-Lima, Ludmila M.

    2016-01-01

    Abstract Crawley, AA, Sherman, RA, Crawley, WR, and Cosio-Lima, LM. Physical fitness of police academy cadets: baseline characteristics and changes during a 16-week academy. J Strength Cond Res 30(5): 1416–1424, 2016—Police academies traditionally emphasize the importance of being physically fit. The purpose of this research was to determine cadet baseline physical fitness characteristics and assess effectiveness of a 16-week training program. Sixty-eight cadets (61 men, 7 women) volunteered to have baseline physical fitness characteristics assessed, and 55 cadets (49 men, 6 women) completed further testing at weeks 8 and 16. The testing comprised hand grip (strength), arm crank (upper-body power), 30 seconds Wingate (lower body power), sum of skinfolds and percentage body fat (body composition), 40-yard dash (sprint speed), 1 repetition maximum bench press (strength), T-test (agility), and sit-and-reach (flexibility). In addition, cadets completed standardized state testing (push-ups, sit-ups, vertical jump, and half-mile shuttle run). The training program consisted of 1 hour sessions, 3 d·wk−1, including aerobic, plyometrics, body weight, and resistance exercise. Significant changes were found in agility (p < 0.01), upper-body and lower-body peak power (p ≤ 0.05), sit-ups (p < 0.01), push-ups (p ≤ 0.05) across the first 8 weeks, and in agility (p ≤ 0.05), lower-body peak power (p ≤ 0.05), sit-ups (p < 0.01), push-ups (p ≤ 0.05), half-mile shuttle run (p < 0.01) across the full 16 weeks. However, none of the variables showed significant change across the second half of the program (weeks 8–16). A number of individual parameters of physical fitness showed evidence of improvement in the first 8 weeks, whereas none of the variables showed significant improvement in the second 8 weeks. This suggests modifications could be made to increase overall effectiveness of cadet physical training specifically after the 8-week mark. PMID:26466133

  9. The effectiveness of physical education of the military academy cadets during a 4-year study

    Directory of Open Access Journals (Sweden)

    Marić Lela

    2013-01-01

    Full Text Available Background/Aim. The main role of physical education is health and educational practices of cadets and all-round personality development. Instruction executing is successful only when the set requirements are realized. The aim of this study was to evaluate the effectiveness of physical education in order to rise physical capabilities of the Military Academy cadets during a 4-year education. Methods. The study was conducted in the Military Academy, Belgrade. A total of 120 cadets who at the beginning of the study were 19 years ± 6 months and at the end 23 years ± 6 months were included in this study. The study used the following tests for verification and assessment of physical fitness: pull-ups, lifting the trunk from the ground, standing long jump seats, running at 1,600 m and overcoming the infantry obstacles. The data were analyzed using statistical programs to calculate the central and dispersion parameters. The difference in the achieved results in the individual variables were evaluated by the univariate analysis of variance (ANOVA, while the differences in the system variables by region were identified by the multivariate analysis of variance (MANOVA and discriminant analysis. The group membership was determined using profile analysis. Results. There were statistically significant differences in all the tests to evaluate the effectiveness of physical education during a 4-year study, except in the standing long jump test. The best average results in motor capabilities tests, were achieved after two years of study, while in the endurance tests showed the best results achieved at the end of a 4-years studying. Conclusion. The results of overcoming specific tests for the physical abilities of the Military Academy cadets show that the physical education curriculum only slightly improves the development of physical skills of cadets during a 4-year study. The existing program shows the best results in the pull-ups test of the ground troops, and

  10. 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

    OpenAIRE

    Maffulli Nicola; Madhok Rajan; Hewitt Catherine; Hamilton Sharon; Goodchild Lorna; Gardner Sarah; Dumville Jo; Cross Ben; Chuang Ling-Hsiang; Armstrong Alison; Dennis Laura; Torgerson David; Rangan Amar; Brealey Stephen; Handoll Helen

    2009-01-01

    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 o...

  11. The impact of study design and diagnostic approach in a large multi-centre ADHD study: Part 2: Dimensional measures of psychopathology and intelligence.

    LENUS (Irish Health Repository)

    Muller, Ueli C

    2011-04-07

    Abstract Background The International Multi-centre ADHD Genetics (IMAGE) project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with ADHD and 1446 unselected siblings. The aim was to describe and analyse questionnaire data and IQ measures from all probands and siblings. In particular, to investigate the influence of age, gender, family status (proband vs. sibling), informant, and centres on sample homogeneity in psychopathological measures. Methods Conners\\' Questionnaires, Strengths and Difficulties Questionnaires, and Wechsler Intelligence Scores were used to describe the phenotype of the sample. Data were analysed by use of robust statistical multi-way procedures. Results Besides main effects of age, gender, informant, and centre, there were considerable interaction effects on questionnaire data. The larger differences between probands and siblings at home than at school may reflect contrast effects in the parents. Furthermore, there were marked gender by status effects on the ADHD symptom ratings with girls scoring one standard deviation higher than boys in the proband sample but lower than boys in the siblings sample. The multi-centre design is another important source of heterogeneity, particularly in the interaction with the family status. To a large extent the centres differed from each other with regard to differences between proband and sibling scores. Conclusions When ADHD probands are diagnosed by use of fixed symptom counts, the severity of the disorder in the proband sample may markedly differ between boys and girls and across age, particularly in samples with a large age range. A multi-centre design carries the risk of considerable phenotypic differences between centres and, consequently, of additional heterogeneity of the sample even if standardized diagnostic procedures are used. These

  12. A large multi-centre European study validates high-sensitivity C-reactive protein (hsCRP) as a clinical biomarker for the diagnosis of diabetes subtypes

    DEFF Research Database (Denmark)

    Thanabalasingham, G.; Shah, N.; Vaxillaire, M.;

    2011-01-01

    An accurate molecular diagnosis of diabetes subtype confers clinical benefits; however, many individuals with monogenic diabetes remain undiagnosed. Biomarkers could help to prioritise patients for genetic investigation. We recently demonstrated that high-sensitivity C-reactive protein (hs......CRP) levels are lower in UK patients with hepatocyte nuclear factor 1 alpha (HNF1A)-MODY than in other diabetes subtypes. In this large multi-centre study we aimed to assess the clinical validity of hsCRP as a diagnostic biomarker, examine the genotype-phenotype relationship and compare different hsCRP assays....... High-sensitivity CRP levels were analysed in individuals with HNF1A-MODY (n = 457), glucokinase (GCK)-MODY (n = 404), hepatocyte nuclear factor 4 alpha (HNF4A)-MODY (n = 54) and type 2 diabetes (n = 582) from seven European centres. Three common assays for hsCRP analysis were evaluated. We excluded 121...

  13. Psicologia positiva em ambientes militares: bem-estar subjetivo entre cadetes do Exército Brasileiro

    Directory of Open Access Journals (Sweden)

    Francisco Heitor Rosa

    2014-09-01

    Full Text Available Positive psychology is the scientific study of optimal human functioning. Subjective well-being is a psychological characteristic commonly associated with happiness. military psychology is a psychology’s microcosm, defined by activity at a military environment. Military environments are, frequently, dangerous and stressing. Thus, tests adapted to a military environment are necessary for several different purposes. In this survey, 373 military academy cadets and 73 college students answered a socio-demographic questionnaire and the Life-Satisfaction Scale. No significant differences were found between these groups. However, cadets whose fathers were in the military were more pleased with their lives than other cadets. The scale internal consistency was adequate for the total sample (0,85 and for the military sample (0,86, pointing to its usefulness at military environments.

  14. Surface-induced intramolecular electron transfer in multi-centre redox metalloproteins: the di-haem protein cytochrome c4 in homogeneous solution and at electrochemical surfaces

    Science.gov (United States)

    Chi, Qijin; Zhang, Jingdong; Jensen, Palle S.; Nazmudtinov, Renat R.; Ulstrup, Jens

    2008-09-01

    Intramolecular electron transfer (ET) between transition metal centres is a core feature of biological ET and redox enzyme function. The number of microscopic redox potentials and ET rate constants is, however, mostly prohibitive for experimental mapping, but two-centre proteins offer simple enough communication networks for complete mapping to be within reach. At the same time, multi-centre redox proteins operate in a membrane environment where conformational dynamics and ET patterns are quite different from the conditions in a homogeneous solution. The bacterial respiratory di-haem protein Pseudomonas stutzeri cytochrome c4 offers a prototype target for environmental gating of intra-haem ET. ET between P. stutzeri cyt c4 and small molecular reaction partners in solution appears completely dominated by intermolecular ET of each haem group/protein domain, with no competing intra-haem ET, for which accompanying propionate-mediated proton transfer is a further barrier. The protein can, however, be immobilized on single-crystal, modified Au(111) electrode surfaces with either the low-potential N terminal or the high-potential C terminal domain facing the surface, clearly with fast intramolecular ET as a key feature in the electrochemical two-ET process. This dual behaviour suggests a pattern for multi-centre redox metalloprotein function. In a homogeneous solution, which is not the natural environment of cyt c4, the two haem group domains operate largely independently with conformations prohibitive for intramolecular ET. Binding to a membrane or electrochemical surface, however, triggers conformational opening of intramolecular ET channels. The haem group orientation in P. stutzeri cyt c4 is finally noted to offer a case for orientation dependent electronic rectification between a substrate and a tip in electrochemical in situ scanning tunnelling microscopy or nanoscale electrode configurations.

  15. The outcome of a multi-centre feasibility study of online adaptive radiotherapy for muscle-invasive bladder cancer TROG 10.01 BOLART

    International Nuclear Information System (INIS)

    Purpose: To assess whether online adaptive radiotherapy for bladder cancer is feasible across multiple Radiation Oncology departments using different imaging, delivery and recording technology. Materials and methods: A multi-centre feasibility study of online adaptive radiotherapy, using a choice of three “plan of the day”, was conducted at 12 departments. Patients with muscle-invasive bladder cancer were included. Departments were activated if part of the pilot study or after a site-credentialing visit. There was real time review of the first two cases from each department. Results: 54 patients were recruited, with 50 proceeding to radiotherapy. There were 43 males and 7 females with a mean age of 78 years. The tumour stages treated included T1 (1 patient), T2 (35), T3 (10) and T4 (4). One patient died of an unrelated cause during radiotherapy. The three adaptive plans were created before the 10th fraction in all cases. In 8 (16%) of the patients, a conventional plan using a ‘standard’ CTV to PTV margin of 1.5 cm was used for one or more fractions where the pre-treatment bladder CTV was larger than any of the three adaptive plans. The bladder CTV extended beyond the PTV on post treatment imaging in 9 (18%) of the 49 patients. Conclusions: From a technical perspective an online adaptive radiotherapy technique can be instituted in a multi-centre setting. However, without further bladder filling control or imaging, a CTV to PTV margin of 7 mm is insufficient

  16. MILITARY PATRIOTIC EDUCATION OF CADETS IN A MARITIME UNIVERSITY: THE ESSENCE AND THE DEFINITION

    Directory of Open Access Journals (Sweden)

    Dorofeev A. M.

    2015-06-01

    Full Text Available The development of the political, the military and the economic power of the Russian Federation is impossible without development of patriotism and without stirring up the most important part of military-patriotic education of youth, including, of course, cadets of maritime colleges. Nowadays, the patriotism is demanded by society as a state ideology, as a most important condition and the way of spiritual and economic revival of Russia; it’s demanded as a way to unite and consolidate the entire population of Russia and as the answer to provocation from western countries seeking to weakening of Russia and finally to the collapse of the Russian world. Patriotism can be understood as a moral-political principle, social feeling, that consist of love and devotion to Fatherland, pride for it’s past and present, tendency to protect the interests of Homeland. Patriotism is expressed in love and devotion to its own Homeland, native land and its own nation, its history and culture. In present conditions, the most important direction and formation of patriotic qualities among maritime cadets can and is to be military-patriotic education, carried out on a base of regulatory documents, heroic history or Fatherland, military traditions of army and navy. Loyalty to the Fatherland, sincere love to the own country, moral-psychological and military-professional alacrity to armed protection of the Fatherland in the armed forces of the Russian Federation- it is quintessence of military – patriotic education and so it differs from patriotic education of Russian citizens. In the article it is considered the core of the military-patriotical education, based on analysis of local scientists’ views; we have formulated the goal, the tasks and the pedagogic conditions of military-patriotic education of maritime cadets; we have made an attempt to give author’s definition the term of “maritime college military-patriotic education of cadets”

  17. Generación y dibujo de escaleras con el programa CADET

    Directory of Open Access Journals (Sweden)

    Recuero, Alfonso

    1987-04-01

    Full Text Available This paper shows soma of the possibilities offers by the program CADET to do perspective drawings of 3-D objects. Stair cases with any plant have been chosen as sample case. A detailed description of every step needed in a particular case is included together with the perspective drawings obtained in several other cases. The listings of the subroutines, written in HP-BASIC, which allow the definition of the plant and the automatic generation of the elements used to discretize the stair cases, are also included.

    En el presente trabajo se muestra un ejemplo de las posibilidades que ofrece el programa CADET para el dibujo de perspectivas de objetos tridimensionales. Para ello, se ha elegido el caso de dibujo de perspectivas de escaleras, con plantas de forma general. Se incluye una descripción detallada para un ejemplo concreto, así como, las perspectivas obtenidas para una variada gama de casos. Se incluyen también, los listados de las subrutinas, en HP-BASIC, que permiten definir la planta de la escalera y generar los elementos planos utilizados en su discretización.

  18. Planning the annual cycle in groups of cadet combat sports perfection

    Directory of Open Access Journals (Sweden)

    Ananchenko Konstantin

    2016-08-01

    Full Text Available Within a large training cycle in conditions of high general level of stress the authors recommend optimal implementation of planning undulating dynamics of cadets’ combat exercise stress. The article proves the efficiency of one-cycle construction of training highly- qualified single-combat cadets at the stage of maximal realization of sporting possibilities, which includes both features of traditional cycles (preparatory, competitional, transitional and module-sectional composition of training. It scientifically substantiates, that the choice of those or other types of microcycles which present the structure of mesocycles is determined by a few basic factors which must be necessarily taken into account while planning the training process of sportsmen of different qualification. It is suggested to use certain varieties of microcycles in the practice of preparation of single combat cadets. It is substantiated that accounting in planning the annual cycle in groups of sporting perfection of students of the educed types of microcycles for every type of single combats is an actual task of further scientific research.

  19. Validity of Bioelectrical Impedance Analysis to Estimation Fat-Free Mass in the Army Cadets

    Directory of Open Access Journals (Sweden)

    Raquel D. Langer

    2016-03-01

    Full Text Available Background: Bioelectrical Impedance Analysis (BIA is a fast, practical, non-invasive, and frequently used method for fat-free mass (FFM estimation. The aims of this study were to validate predictive equations of BIA to FFM estimation in Army cadets and to develop and validate a specific BIA equation for this population. Methods: A total of 396 males, Brazilian Army cadets, aged 17–24 years were included. The study used eight published predictive BIA equations, a specific equation in FFM estimation, and dual-energy X-ray absorptiometry (DXA as a reference method. Student’s t-test (for paired sample, linear regression analysis, and Bland–Altman method were used to test the validity of the BIA equations. Results: Predictive BIA equations showed significant differences in FFM compared to DXA (p < 0.05 and large limits of agreement by Bland–Altman. Predictive BIA equations explained 68% to 88% of FFM variance. Specific BIA equations showed no significant differences in FFM, compared to DXA values. Conclusion: Published BIA predictive equations showed poor accuracy in this sample. The specific BIA equations, developed in this study, demonstrated validity for this sample, although should be used with caution in samples with a large range of FFM.

  20. 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

  1. Tyrosine improves cognitive performance and reduces blood pressure in cadets after one week of combat training course

    NARCIS (Netherlands)

    Deijen, J.B.; Wientjes, C.J.E.; Vullinghs, H.F.M.; Cloin, P.A.; Langeveld, J.J.

    1999-01-01

    The effect of the amino acid tyrosine on cognitive task performance were studied on a group of 21 cadets during a demanding military combat training course. In addition, the effects on mood, blood pressure and the norepinephrine metabolite MHPG were determined. Ten subjects received five daily doses

  2. Formation of Official Loyalty of Cadets in Educational Process of Higher Educational Institutions of Russian Penitentiary System

    Science.gov (United States)

    Sabirova, Elvira G.; Gornostaev, Stanislav V.; Kirillova, Tatiana V.; Moiseenko, Irina F.

    2016-01-01

    This article is aimed at revealing the foundations of the formation of the official loyalty among the cadets of higher education institutions of the FPS of Russia by the institutions staff, and first of all, by the faculty. Leading methods of research of this problem in this article were: the analysis of scientific papers and official documents,…

  3. The impact of study design and diagnostic approach in a large multi-centre ADHD study. Part 1: ADHD symptom patterns.

    LENUS (Irish Health Repository)

    Muller, Ueli C

    2011-04-07

    Abstract Background The International Multi-centre ADHD Genetics (IMAGE) project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with the combined type of attention deficit\\/hyperactivity disorder (ADHD-CT) and 1446 \\'unselected\\' siblings. The aim was to analyse the IMAGE sample with respect to demographic features (gender, age, family status, and recruiting centres) and psychopathological characteristics (diagnostic subtype, symptom frequencies, age at symptom detection, and comorbidities). A particular focus was on the effects of the study design and the diagnostic procedure on the homogeneity of the sample in terms of symptom-based behavioural data, and potential consequences for further analyses based on these data. Methods Diagnosis was based on the Parental Account of Childhood Symptoms (PACS) interview and the DSM-IV items of the Conners\\' teacher questionnaire. Demographics of the full sample and the homogeneity of a subsample (all probands) were analysed by using robust statistical procedures which were adjusted for unequal sample sizes and skewed distributions. These procedures included multi-way analyses based on trimmed means and winsorised variances as well as bootstrapping. Results Age and proband\\/sibling ratios differed between participating centres. There was no significant difference in the distribution of gender between centres. There was a significant interaction between age and centre for number of inattentive, but not number of hyperactive symptoms. Higher ADHD symptom frequencies were reported by parents than teachers. The diagnostic symptoms differed from each other in their frequencies. The face-to-face interview was more sensitive than the questionnaire. The differentiation between ADHD-CT probands and unaffected siblings was mainly due to differences in hyperactive

  4. The influence of sample volume applied to the Makler sperm counting chamber upon the measured concentration of latex beads:A multi-centre study

    Institute of Scientific and Technical Information of China (English)

    Melanie Walls; Cherise Mooy; Patrick Mohan; Sally Catt; Matthew Wiltshire; Hassan W Bakos; Mary Whyte; Phillip Matson; Emily Zuvela; Cheryl Ayres; Deborah Sherrin; Asma Chhotani; Liz Butler; Kelli Peirce; Jenny Krapez; Renae Parker

    2012-01-01

    Objective:To undertake a multi-centre study to maximize the number ofMakler chambers used.Methods:A total of15 laboratories participated with31Makler chambers.A suspension of latex beads was prepared to a concentration of20 millions per milliliter, and0.5 mL aliquots distributed to each participating laboratory.They measured the concentration on theirMakler chamber(s) used for routine semen analysis by adding3,4,5,7 and10µL volumes of bead suspension to the chamber.Results:There was no difference in within-chamber analysis of the bead concentration according to the volume of bead suspension applied within the range of 3-10µL(F4,14=2.634,P=0.056).However, the between-chamber effects were significantly different (F30,124=4.937,P=0.000), and24/31(77.5%) chambers tested had an average bias>10% compared to the target bead concentration.Conclusions:A volume of3-10µL added toMakler counting chambers does not influence the concentration measured of latex beads, but the between-chamber variability and positive bias seen would suggest that other sources of error are present which are yet to be identified.

  5. The effect of two cognitive aid designs on team functioning during intra-operative anaphylaxis emergencies: a multi-centre simulation study.

    Science.gov (United States)

    Marshall, S D; Sanderson, P; McIntosh, C A; Kolawole, H

    2016-04-01

    This multi-centre repeated measures study was undertaken to determine how contrasting designs of cognitive aids affect team performance during simulated intra-operative anaphylaxis crises. A total of 24 teams consisting of a consultant anaesthetist, an anaesthetic trainee and anaesthetic assistant managed three simulated intra-operative anaphylaxis emergencies. Each team was assigned at random to a counterbalanced order of: no cognitive aid; a linear cognitive aid; and a branched cognitive aid, and scored for team functioning. Scores were significantly higher with a linear compared with either a branched version of the cognitive aid or no cognitive aid for 'Team Overall Behavioural Performance', difference between study groups (F-value) 5.8, p = 0.01. Aggregate scores were higher with the linear compared with the branched aid design (p = 0.03). Cognitive aids improve co-ordination of the team's activities and support team members to verbalise their actions. A linear design of cognitive aid improves team functioning more than a branched design.

  6. A multi-centre investigation towards reaching a consensus on the immunohistochemical detection of ERbeta in archival formalin-fixed paraffin embedded human breast tissue.

    Science.gov (United States)

    Carder, Pauline J; Murphy, Claire E; Dervan, Peter; Kennedy, Maria; McCann, Amanda; Saunders, Philippa T K; Shaaban, Abeer M; Foster, Christopher S; Witton, Caroline J; Bartlett, John M S; Walker, Rosemary A; Speirs, Valerie

    2005-08-01

    Estrogen receptor (ER) alpha is a well-established independent prognostic factor in breast cancer whose presence determines the clinical implications of adjuvant endocrine therapy. A second receptor, ERb has been described, and a number of studies have examined its expression in breast tissue. However elucidation of the role played by ERb has been hampered by published immunohistochemical studies employing a variety of protocols and scoring systems such that inter-laboratory comparisons are difficult. Here we present a multi-centre study designed to critically evaluate inter-laboratory differences in methodology. Six UK and Irish centres participated in this study. A small series of breast cancers were stained using centre-specific laboratory protocols and scored using both centrespecific and standard scoring protocols. There was generally poor agreement as to what constituted a positive or negative case when centre-specific scoring systems were used with less than half of all cases in agreement. Concordance was improved when a standard scoring system was used but varied according to threshold for positivity employed and primary antibody. Our results emphasise the need for further studies addressing the role of ERb to be based on a wider consensus on criteria for positivity. Ideally this should be based on calibration against clinical outcome.

  7. A multi-centre, prospective, clinical in-market evaluation to assess the performance of Opsite™ Post-Op Visible dressings.

    LENUS (Irish Health Repository)

    O'Brien, Gillian

    2010-10-01

    The aim of this study was to assess the performance of Opsite™ Post-Op Visible as a post-surgical dressing in a typical clinical setting. In this multi-centre clinical evaluation, patients who underwent clean surgery were treated with Opsite Post-Op Visible dressing. Duration of dressing wear, visibility through the dressing and ability to handle exudate were assessed and the product was rated in comparison with those normally used. A total of 64 patients were recruited. Mean wear time was 4·5 days. Exudate management was rated very good or good at 96% of assessments. Visibility of the incision site was rated as very good or good at 72%, and as acceptable at 24%, of assessments. Patient comfort was rated very comfortable (63%) or comfortable (37%) at all assessments. Dressings were generally rated as satisfactory or exceeding expectations with clinicians stating that the Opsite Post-Op Visible dressing was better than the dressing they routinely used for 92% of patients. Opsite Post-Op Visible dressing is an innovative dressing combining good visibility with exudate management and patient comfort. It was found to have adequate wear time, visibility and exudate management properties making it suitable for use on a variety of surgical incision sites.

  8. 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...

  9. 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...

  10. A randomised controlled trial of oxytocin 5IU and placebo infusion versus oxytocin 5IU and 30IU infusion for the control of blood loss at elective caesarean section--pilot study. ISRCTN 40302163.

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2012-02-01

    OBJECTIVE: To compare the blood loss at elective lower segment caesarean section with administration of oxytocin 5IU bolus versus oxytocin 5IU bolus and oxytocin 30IU infusion and to establish whether a large multi-centre trial is feasible. STUDY DESIGN: Women booked for an elective caesarean section were recruited to a pilot randomised controlled trial and randomised to either oxytocin 5IU bolus and placebo infusion or oxytocin 5IU bolus and oxytocin 30IU infusion. We wished to establish whether the study design was feasible and acceptable and to establish sample size estimates for a definitive multi-centre trial. The outcome measures were total estimated blood loss at caesarean section and in the immediate postpartum period and the need for an additional uterotonic agent. RESULTS: A total of 115 women were randomised and 110 were suitable for analysis (5 protocol violations). Despite strict exclusion criteria 84% of the target population were considered eligible for study participation and of those approached only 15% declined to participate and 11% delivered prior to the planned date. The total mean estimated blood loss was lower in the oxytocin infusion arm compared to placebo (567 ml versus 624 ml) and fewer women had a major haemorrhage (>1000 ml, 14% versus 17%) or required an additional uterotonic agent (5% versus 11%). A sample size of 1500 in each arm would be required to demonstrate a 3% absolute reduction in major haemorrhage (from baseline 10%) with >80% power. CONCLUSION: An additional oxytocin infusion at elective caesarean section may reduce blood loss and warrants evaluation in a large multi-centre trial.

  11. MODEL FOR THE FORMATION OF ECOLOGICAL CULTURE OF THE MILITARY HIGH SCHOOL CADETS IN THE MUSEUM EDUCATIONAL CONTEXT IN THE PROCESS OF RESEARCH ACTIVITIES

    OpenAIRE

    E. V. Khrabrova

    2014-01-01

    The article covers the formation of ecological culture of military high school cadets in the process of the museum’s research activities. The author defines the main mechanism of ecological culture formation, being characteristic of military high school cadets, and believes that the development of the cadets’ ecological culture, while they are engaged in the research process, will be effective, provided an innovative research context has been set up within the educational activities scope of ...

  12. The analysis of the physical statement of cadets of the 1st course of the military Institute on the starting stage of studying

    Directory of Open Access Journals (Sweden)

    Ovcharuk I.S.

    2010-11-01

    Full Text Available The physical state of the youth which fulfills the rows of military forces of Ukraine has no tendency to improve according to the health and physical preparation. The physical state of cadets of the 1st course is analyzed. 69 cadets took part in research. It improves from the first month of being in educational establishment. Studying curriculum of this educational establishment must provide the fulfillment of all the tasks of physical preparation of military forces of Ukraine.

  13. Gender Differentiations of Some Anthropological Characteristics of Karate Players--Cadets.

    Science.gov (United States)

    Jukić, Josefina

    2015-07-01

    The research was conducted with the aim of determining gender differentiations of some anthropological characteristics of male and female cadet karate players. To achieve this aim, a group of 10 morphological variables, ten motor tests, five situation motor test and six technical performance evaluation tests was applied. Two hundred and six competing players were measured, of which 105 male and 101 female. The examinees were divided according to weight categories (lower and higher weight categories). Based on the variance analysis and canon discrimination analysis a conclusion can be made: gender differentiations are most strongly expressed in morphological and basic motor area, and significantly less in the area of specific motor abilities and motor knowledge (technical efficiency).

  14. Some Thoughts on Cadet Leadership Cultivation%对军校学员领导力培养问题的若干思考

    Institute of Scientific and Technical Information of China (English)

    范冉冉

    2012-01-01

    军校学员的领导力,在未来战场上就是战斗力。加强军校学员领导力的培养,是中国特色军事变革对军校教育提出的新要求。分析了军校学员领导力的内涵及构成要素,在考察美军培养经验的基础上,针对我军院校当前现状,对推进我军学员领导力培养的有效途径进行了初步探索。%Cadet Leadership is a battle force in the future battlefield. Strengthening the Cadet Leadership cultivation is the new requirements of the revolution in military affairs with Chinese characteristics on the military education. This paper ana- lyzes the connotation and elements of the cadet leadership, and studies the US cadet leadership cultivation on the basis of experience. In view of the current cultivation deficiencies in the PLA cadet leadership,it undertakes initial exploration on how to accelerate cadet leadership cultivation.

  15. Post-exercise proteinuria in the cadets trained on Special Aerial Gymnastics Instruments

    Directory of Open Access Journals (Sweden)

    Zbigniew Wochyński

    2015-10-01

    Full Text Available Objectives: Assessment of the effect of training on Special Aerial Gymnastics Instruments (SAGI on the urine β-2- microglobulin (β-2M, albumin (ALB, total protein (TP, N-acetyl-β-D-glucosaminidase EC.3.2.1.30 (NAG, expressed as creatinine (Cr and on the physical fitness of the examined cadets in comparison with the control group. Material and Methods: The study involved 55 cadets aged 20, divided into group A (N = 41 trained on SAGI, and group B (N = 14 – a control group. The urine was collected twice: before the training (BT and after the training (AT at the start (training I, during (training II, and after completion of the training program (training III. Urine proteins were assayed with commercially available kits. Results: In group A, results obtained in trainings I, II and III showed a statistically significant increase in β-2M/Cr, NAG/Cr, TP/Cr, ALB/Cr indices in AT compared with the baseline BT values. Similarly in group B, a statistically significant increase in β-2M/Cr, NAG/Cr (trainings I, II, TP/Cr, AT compared with the baseline BT values in trainings I, II, and III was noted. Comparison of both groups showed a higher value of the post-exercise proteinuria in group B than in group A. In group A, a significant correlation between TP/Cr vs. ALB/Cr, NAG/Cr vs. TP/Cr, β-2M/Cr vs. TP/Cr, i.e., r = 0.62 at p < 0.001; r = 0.33 at p = 0.03; r = 0.60 at p < 0.001, and r = 0.52 at p < 0.001, respectively, was observed in group A, training III, AT. Conclusions: Assayed urine proteins depend on the intensity of physical exercise, the type of exercise, and the level of physical fitness.

  16. Cognitive behaviour therapy plus aerobic exercise training to increase activity in patients with myotonic dystrophy type 1 (DM1) compared to usual care (OPTIMISTIC): study protocol for randomised controlled trial

    OpenAIRE

    van Engelen, B. G.; Groot, Perry

    2015-01-01

    BACKGROUND: Myotonic dystrophy type 1 (DM1) is a rare, inherited chronic progressive disease as well as an autosomal dominant multi-systemic disorder. It is probably one of the most common adult forms of muscular dystrophy, with a prevalence of approximately 10 per 100,000 people affected. With 733 million people in Europe, we estimate that 75,000 people in Europe are affected with DM1. METHODS/DESIGN: OPTIMISTIC is a multi-centre, randomised trial designed to compare an intervention comprisi...

  17. Multi-centre evaluation of the Determine HIV Combo assay when used for point of care testing in a high risk clinic-based population.

    Directory of Open Access Journals (Sweden)

    Damian P Conway

    Full Text Available BACKGROUND: Determine HIV Combo (DHC is the first point of care assay designed to increase sensitivity in early infection by detecting both HIV antibody and antigen. We conducted a large multi-centre evaluation of DHC performance in Sydney sexual health clinics. METHODS: We compared DHC performance (overall, by test component and in early infection with conventional laboratory HIV serology (fourth generation screening immunoassay, supplementary HIV antibody, p24 antigen and Western blot tests when testing gay and bisexual men attending four clinic sites. Early infection was defined as either acute or recent HIV infection acquired within the last six months. RESULTS: Of 3,190 evaluation specimens, 39 were confirmed as HIV-positive (12 with early infection and 3,133 were HIV-negative by reference testing. DHC sensitivity was 87.2% overall and 94.4% and 0% for the antibody and antigen components, respectively. Sensitivity in early infection was 66.7% (all DHC antibody reactive and the DHC antigen component detected none of nine HIV p24 antigen positive specimens. Median HIV RNA was higher in false negative than true positive cases (238,025 vs. 37,591 copies/ml; p = 0.022. Specificity overall was 99.4% with the antigen component contributing to 33% of false positives. CONCLUSIONS: The DHC antibody component detected two thirds of those with early infection, while the DHC antigen component did not enhance performance during point of care HIV testing in a high risk clinic-based population.

  18. Species distribution and susceptibility profile to fluconazole, voriconazole and MXP-4509 of 551 clinical yeast isolates from a Romanian multi-centre study.

    Science.gov (United States)

    Minea, B; Nastasa, V; Moraru, R F; Kolecka, A; Flonta, M M; Marincu, I; Man, A; Toma, F; Lupse, M; Doroftei, B; Marangoci, N; Pinteala, M; Boekhout, T; Mares, M

    2015-02-01

    This is the first multi-centre study regarding yeast infections in Romania. The aim was to determine the aetiological spectrum and susceptibility pattern to fluconazole, voriconazole and the novel compound MXP-4509. The 551 isolates were identified using routine laboratory methods, matrix-assisted laser desorption ionisation time-of-flight mass spectrometry (MALDI-TOF MS) and DNA sequence analysis. Susceptibility testing was performed using the European Committee for Antimicrobial Susceptibility Testing (EUCAST) method and breakpoints. The yeasts originated from superficial infections (SUP, 51.5 %), bloodstream infections (BSI, 31.6 %) and deep-seated infections (DEEP, 16.9 %), from patients of all ages. Nine genera and 30 species were identified. The 20 Candida species accounted for 94.6 % of all isolates. C. albicans was the overall leading pathogen (50.5 %). Lodderomyces elongisporus is reported for the first time as a fungaemia cause in Europe. C. glabrata and Saccharomyces cerevisiae, as well as the non-Candida spp. and non-albicans Candida spp. groups, showed decreased fluconazole susceptibility (fluconazole resistance was 10.2 %. C. krusei accounted for 27 of the 56 fluconazole-resistant isolates. The overall voriconazole resistance was 2.5 % and was due mainly to C. glabrata and C. tropicalis isolates. Fluconazole resistance rates for the three categories of infection were similar to the overall value; voriconazole resistance rates differed: 4 % for BSI, 3.2 % for DEEP and 1.4 % for SUP. The antifungal activity of MXP-4509 was superior to voriconazole against C. glabrata and many fluconazole-resistant isolates. There was a large percentage of non-albicans Candida isolates. A large part of the high fluconazole resistance was not acquired but intrinsic, resulting from the high percentage of C. krusei.

  19. Visceral leishmaniasis on the Indian sub-continent: a multi-centre study of the costs of three interventions for the control of the sandfly vector, Phlebotomus argentipes.

    Science.gov (United States)

    Das, M; Banjara, M; Chowdhury, R; Kumar, V; Rijal, S; Joshi, A; Akhter, S; Das, P; Kroeger, A

    2008-12-01

    The sandflies that transmit the parasites causing human visceral leishmaniasis (VL) can be controlled by several methods, including indoor residual spraying (IRS), the use of long-lasting insecticidal nets (LLIN) and ecological vector management (EVM). The financial costs of each of these three methods of sandfly control have recently been assessed and compared, in a multi-centre study based on the Indian sub-continent. In each of the four study sites (two in Nepal and one each in India and Bangladesh), 24 neighbourhoods were randomly selected in districts with high incidences of VL. The costs of the three interventions were then prospectively assessed in each study neighbourhood, in the local currency, and then converted to U.S. dollars at the prevailing exchange rate in the country concerned. The costs of IRS, which ranged from U.S.$2.4-11.7 (mean = U.S.$5.9) per household-year, were greater than those of LLIN (U.S.$3.5-5.1/household-year, with a mean of U. S.$4.5) but less than those of EVM (U. S.$5.0- 14.0/household-year, with a mean of U.S.$8.7). These results indicate that LLIN and IRS may be the cheaper options for the control of sandflies on the Indian sub-continent, and that EVM should perhaps only be taken up as a complimentary and voluntary method. Various combinations of these interventions (based on country-specific social and economic factors) may, however, be the best and most cost-effective choice.

  20. Recommendations for implementing stereotactic radiotherapy in peripheral stage IA non-small cell lung cancer: report from the Quality Assurance Working Party of the randomised phase III ROSEL study

    International Nuclear Information System (INIS)

    A phase III multi-centre randomised trial (ROSEL) has been initiated to establish the role of stereotactic radiotherapy in patients with operable stage IA lung cancer. Due to rapid changes in radiotherapy technology and evolving techniques for image-guided delivery, guidelines had to be developed in order to ensure uniformity in implementation of stereotactic radiotherapy in this multi-centre study. A Quality Assurance Working Party was formed by radiation oncologists and clinical physicists from both academic as well as non-academic hospitals that had already implemented stereotactic radiotherapy for lung cancer. A literature survey was conducted and consensus meetings were held in which both the knowledge from the literature and clinical experience were pooled. In addition, a planning study was performed in 26 stage I patients, of which 22 were stage 1A, in order to develop and evaluate the planning guidelines. Plans were optimised according to parameters adopted from RTOG trials using both an algorithm with a simple homogeneity correction (Type A) and a more advanced algorithm (Type B). Dose conformity requirements were then formulated based on these results. Based on current literature and expert experience, guidelines were formulated for this phase III study of stereotactic radiotherapy versus surgery. These guidelines can serve to facilitate the design of future multi-centre clinical trials of stereotactic radiotherapy in other patient groups and aid a more uniform implementation of this technique outside clinical trials

  1. Formation of tactics of actions of cadets taking into account their cerebration during training in higher education institution

    Directory of Open Access Journals (Sweden)

    Yuri Sergienko

    2016-09-01

    Full Text Available Purpose: the formation of tactical actions of cadets taking into account their cerebration on classes in the subject matters, which is connected with modeling of situations on office activity. Material & Methods: the analysis of law-enforcement practice when carrying out various operational investigative actions, which are connected with the detention of offenders and their prosecution. The computer tests of assessment of psychophysiological abilities of sportsmen, which are developed by V. S. Ashanin were used, for carrying out the research. The experiment (n=25 is made during four years. Results: the main psychophysiological processes of cerebration at cadets-law enforcement authorities on special physical preparation classes, tactical-special preparation and tactics of behavior of the employee of fiscal service with organic firearms in unusual situations are established. Conclusions: the structure and the model of preparation are experimentally proved and specified, the role of interrelations of physical and psychophysiological qualities is opened.

  2. 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...

  3. Muscle Strength and Qualitative Jump-Landing Differences in Male and Female Military Cadets: The Jump-ACL Study

    OpenAIRE

    Boden, Barry P.; Padua, Darin A.; Stephen W Marshall; de la Motte, Sarah J.; Beutler, Anthony I.

    2009-01-01

    Recent studies have focused on gender differences in movement patterns as risk factors for ACL injury. Understanding intrinsic and extrinsic factors which contribute to movement patterns is critical to ACL injury prevention efforts. Isometric lower- extremity muscular strength, anthropometrics, and jump-landing technique were analyzed for 2,753 cadets (1,046 female, 1,707 male) from the U.S. Air Force, Military and Naval Academies. Jump- landings were evaluated using the Landing Error Scoring...

  4. Cadet Education in the Imperial Russia: Genesis, Dialectics and the Role in Social Structure of the Society

    Directory of Open Access Journals (Sweden)

    Alexander P. Abramov

    2014-06-01

    Full Text Available The article, using historic and sociological material, presents genesis, dialectics and the role of cadet education of the imperial Russia in the social structure of the society, its weak and strong aspects, determines major stratified features of its graduates. The author notes that the realization of the practice of professional socialization in cadet corps in certain historical period is determined by the social conditions and the factors of the development of the society, its structure and environment, reproducing the modal personality of the future officer. The professional environment of the cadet education in the imperial Russia is defined as closed, line, self-organizing system. Such environment provided the graduates with high social status and prestige in different fields, defined by generic characteristics (affiliation to nobility. Along with high educational and cultural level, modal personality of the graduate is characterized by aloofness from the juniors and subordinates, individualism and careerism, certain closedness towards one’s nation and other social groups.

  5. Efficacy of a Ventilatory Training Mask to Improve Anaerobic and Aerobic Capacity in Reserve Officers' Training Corps Cadets.

    Science.gov (United States)

    Sellers, John H; Monaghan, Taylor P; Schnaiter, Jessica A; Jacobson, Bert H; Pope, Zachary K

    2016-04-01

    The purpose of this study was to examine the efficacy of a ventilatory training mask to improve anaerobic and aerobic fitness in reserve officers' training corps (ROTC) cadets. Seventeen ROTC cadets from a Midwest university completed pre- and postassessments consisting of anthropometry, a 30-second Wingate Anaerobic Test (WAnT), and a maximal aerobic capacity test (V[Combining Dot Above]O2max). A 6-week intervention training period was used during which time participants completed their mandatory physical training (PT) sessions. Participants were randomly assigned to either the experimental group (MASK; n = 9) or the control group (CON; n = 8). The ventilatory training masks were adjusted to simulate an altitude of 2,750 m. There was no significant effect (p ≤ 0.05) between groups on fatigue index, anaerobic capacity, peak power, V[Combining Dot Above]O2max, or time to exhaustion. These results suggest that the use of the ventilatory training mask during mandatory PT did not elicit superior aerobic or anaerobic adaptations in ROTC cadets. Therefore, it is recommended that more established simulated altitude training methods be used when incorporating intermittent hypoxic training.

  6. The PneuCarriage Project: A Multi-Centre Comparative Study to Identify the Best Serotyping Methods for Examining Pneumococcal Carriage in Vaccine Evaluation Studies.

    Directory of Open Access Journals (Sweden)

    Catherine Satzke

    2015-11-01

    Full Text Available The pneumococcus is a diverse pathogen whose primary niche is the nasopharynx. Over 90 different serotypes exist, and nasopharyngeal carriage of multiple serotypes is common. Understanding pneumococcal carriage is essential for evaluating the impact of pneumococcal vaccines. Traditional serotyping methods are cumbersome and insufficient for detecting multiple serotype carriage, and there are few data comparing the new methods that have been developed over the past decade. We established the PneuCarriage project, a large, international multi-centre study dedicated to the identification of the best pneumococcal serotyping methods for carriage studies.Reference sample sets were distributed to 15 research groups for blinded testing. Twenty pneumococcal serotyping methods were used to test 81 laboratory-prepared (spiked samples. The five top-performing methods were used to test 260 nasopharyngeal (field samples collected from children in six high-burden countries. Sensitivity and positive predictive value (PPV were determined for the test methods and the reference method (traditional serotyping of >100 colonies from each sample. For the alternate serotyping methods, the overall sensitivity ranged from 1% to 99% (reference method 98%, and PPV from 8% to 100% (reference method 100%, when testing the spiked samples. Fifteen methods had ≥70% sensitivity to detect the dominant (major serotype, whilst only eight methods had ≥70% sensitivity to detect minor serotypes. For the field samples, the overall sensitivity ranged from 74.2% to 95.8% (reference method 93.8%, and PPV from 82.2% to 96.4% (reference method 99.6%. The microarray had the highest sensitivity (95.8% and high PPV (93.7%. The major limitation of this study is that not all of the available alternative serotyping methods were included.Most methods were able to detect the dominant serotype in a sample, but many performed poorly in detecting the minor serotype populations. Microarray with a

  7. Implementation of preventive strength training in residential geriatric care: a multi-centre study protocol with one year of interventions on multiple levels

    Directory of Open Access Journals (Sweden)

    Nieder Ulrike

    2009-11-01

    Full Text Available Abstract Background There is scientific evidence that preventive physical exercise is effective even in high age. In contrast, there are few opportunities of preventive exercise for highly aged people endangered by or actually in need of care. For example, they would not be able to easily go to training facilities; standard exercises may be too intensive and therefore be harmful to them; orientation disorders like dementia would exacerbate individuals and groups in following instructions and keeping exercises going. In order to develop appropriate interventions, these and other issues were assigned to different levels: the individual-social level (ISL, the organisational-institutional level (OIL and the political-cultural level (PCL. Consequently, this conceptional framework was utilised for development, implementation and evaluation of a new strength and balance exercise programme for old people endangered by or actually in need of daily care. The present paper contains the development of this programme labeled "fit for 100", and a study protocol of an interventional single-arm multi-centre trial. Methods The intervention consisted of (a two group training sessions every week over one year, mainly resistance exercises, accompanied by sensorimotor and communicative group exercises and games (ISL, (b a sustainable implementation concept, starting new groups by instructors belonging to the project, followed by training and supervision of local staff, who stepwise take over the group (OIL, (c informing and convincing activities in professional, administrative and governmental contexts, public relation activities, and establishing an advisory council with renowned experts and public figures (PCL. Participating institutions of geriatric care were selected through several steps of quality criteria assessment. Primary outcome measures were continuous documentation of individual participation (ISL, number of groups continued without external financial

  8. 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

    DEFF Research Database (Denmark)

    Brorson, Stig; Olsen, Bo Sanderhoff; Frich, Lars Henrik;

    2009-01-01

    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)....

  9. Cognitive training plus a comprehensive psychosocial programme (OPUS versus the comprehensive psychosocial programme alone for patients with first-episode schizophrenia (the NEUROCOM trial: A study protocol for a centrally randomised, observer-blinded multi-centre clinical trial

    Directory of Open Access Journals (Sweden)

    Melau Marianne

    2011-02-01

    Full Text Available Abstract Background Up to 85% of patients with schizophrenia demonstrate cognitive dysfunction in at least one domain. Cognitive dysfunction plays a major role in functional outcome. It is hypothesized that addition of cognitive training to a comprehensive psychosocial programme (OPUS enhances both cognitive and everyday functional capacity of patients more than the comprehensive psychosocial programme alone. Methods The NEUROCOM trial examines the effect on cognitive functioning and everyday functional capacity of patients with schizophrenia of a 16-week manualised programme of individual cognitive training integrated in a comprehensive psychosocial programme versus the comprehensive psychosocial programme alone. The cognitive training consists of four modules focusing on attention, executive functioning, learning, and memory. Cognitive training involves computer-assisted training tasks as well as practical everyday tasks and calendar training. It takes place twice a week, and every other week the patient and trainer engage in a dialogue on the patient's cognitive difficulties, motivational goals, and progress in competence level. Cognitive training relies on errorless learning principles, scaffolding, and verbalisation in its effort to improve cognitive abilities and teach patients how to apply compensation strategies as well as structured problem solving techniques. At 16-week post-training and at ten-months follow-up, assessments are conducted to investigate immediate outcome and possible long-term effects of cognitive training. We conduct blinded assessments of cognition, everyday functional capacity and associations with the labour market, symptom severity, and self-esteem. Discussion Results from four-month and ten-month follow-ups have the potential of reliably providing documentation of the long-term effect of CT for patients with schizophrenia. Trial Registration Clinicaltrials.gov NCT00472862.

  10. Cognitive training plus a comprehensive psychosocial programme (OPUS) versus the comprehensive psychosocial programme alone for patients with first-episode schizophrenia (the NEUROCOM trial): a study protocol for a centrally randomised, observer-blinded multi-centre clinical trial

    DEFF Research Database (Denmark)

    Vesterager, Lone; Christensen, Torben Østergaard; Olsen, Birthe B;

    2011-01-01

    as practical everyday tasks and calendar training. It takes place twice a week, and every other week the patient and trainer engage in a dialogue on the patient’s cognitive difficulties, motivational goals, and progress in competence level. Cognitive training relies on errorless learning principles...... training integrated in a comprehensive psychosocial programme versus the comprehensive psychosocial programme alone. The cognitive training consists of four modules focusing on attention, executive functioning, learning, and memory. Cognitive training involves computer-assisted training tasks as well...

  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. Morphological, motor and technical determinants of fighting efficiency of Croatian female cadet age karate athletes.

    Science.gov (United States)

    Jukić, Josefina; Katić, Ratko; Bala, Gustav

    2013-12-01

    The aim of this research was to determine the significance of morphological factors, factors of basic motor and specific motor abilities, and the factors of technical efficiency, on the karate fight success in Croatian female cadet karate athletes. With this purpose, the group of 18 anthropometric measures, 10 basic motor tests, 5 situational karate motor tests, the group of 8 evaluations of 6 basic karate techniques, and 2 karate kata performances was applied on the sample of 101 Croatian karateka aged 14 to 16. Inside the morphological area, the factor analysis isolated: Body mass and volume factor, Subcutaneous fat tissue factor, Longitudinal skeleton dimensionality factor, and Transversal fist dimensionality factor; in the basic motor area: General motor efficiency factor; in the situational motor area: General specific motor efficiency factor; in the area of karate technique performance evaluation: General technical efficiency factor. After that, the application of canonical discriminative analysis determined the differences between high and lower quality karate athletes in the overall area of the isolated factors. The discriminative function showed that high quality female karate athletes compared to those of lower quality differ the most in higher technical efficiency, higher basic and specific motor efficiency, while having somewhat less fat tissue and somewhat wider wrist and fist diameter.

  13. Incidence, prevalence, and risk of eating disorder behaviors in military academy cadets.

    Science.gov (United States)

    Beekley, Matthew D; Byrne, Robert; Yavorek, Trudy; Kidd, Kelli; Wolff, Janet; Johnson, Michael

    2009-06-01

    Eating disorders are a particular problem for college students, as well as college athletes and military personnel. We examined the incidence, prevalence, and risk of eating disorders at the United States Military Academy (USMA) over a 7-year period (total population 12,731 cadets). The incidence per year for females was 0.02% for anorexia, 0.17% for bulimia, and 0.17% for eating disorders not otherwise specified (EDNOS) and for males was 0.0% for anorexia, 0.003% for bulimia, and 0.02% for eating disorders not otherwise specified. The total prevalence of diagnosed eating disorders for females was 5% and for males was 0.1%. For females over the 7-year period, we found a prevalence of 0.2% for anorexia, 1.2% for bulimia, 1.2% for eating disorders not otherwise specified, and for males we found a prevalence of 0.0% for anorexia, 0.02% for bulimia, and 0.03% for eating disorders not otherwise specified. Nineteen percent of females and 2% of males scored a 20 or higher on the Eating Attitudes Test (EAT)-26 survey indicating they were at risk for developing an eating disorder. We conclude that the prevalence of eating disorders at USMA is comparable to civilian colleges. PMID:19585779

  14. Field efficacy of a new mosaic long-lasting mosquito net (PermaNet (R) 3.0) against pyrethroid-resistant malaria vectors : a multi centre study in Western and Central Africa

    OpenAIRE

    Corbel, Vincent; Chabi, Joseph; Dabiré, R. K.; Etang, J.; Nwane, P.; Pigeon, O.; Akogbeto, M.; Hougard, Jean-Marc

    2010-01-01

    Background: Due to the spread of pyrethroid-resistance in malaria vectors in Africa, new strategies and tools are urgently needed to better control malaria transmission. The aim of this study was to evaluate the performances of a new mosaic long-lasting insecticidal net (LLIN), i.e. PermaNet (R) 3.0, against wild pyrethroid-resistant Anopheles gambiae s.l. in West and Central Africa. Methods: A multi centre experimental hut trial was conducted in Malanville (Benin), Vallee du Kou (Burkina Fas...

  15. Field efficacy of a new mosaic long-lasting mosquito net (PermaNet® 3.0) against pyrethroid-resistant malaria vectors: a multi centre study in Western and Central Africa

    OpenAIRE

    Pigeon Olivier; Nwane Philippe; Etang Josiane; Dabiré Roch K; Chabi Joseph; Corbel Vincent; Akogbeto Martin; Hougard Jean-Marc

    2010-01-01

    Abstract Background Due to the spread of pyrethroid-resistance in malaria vectors in Africa, new strategies and tools are urgently needed to better control malaria transmission. The aim of this study was to evaluate the performances of a new mosaic long-lasting insecticidal net (LLIN), i.e. PermaNet® 3.0, against wild pyrethroid-resistant Anopheles gambiae s.l. in West and Central Africa. Methods A multi centre experimental hut trial was conducted in Malanville (Benin), Vallée du Kou (Burkina...

  16. 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

  17. 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

  18. 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.

  19. MUSCLE STRENGTH AND QUALITATIVE JUMP-LANDING DIFFERENCES IN MALE AND FEMALE MILITARY CADETS: THE JUMP-ACL STUDY

    Directory of Open Access Journals (Sweden)

    Barry P. Boden

    2009-12-01

    Full Text Available Recent studies have focused on gender differences in movement patterns as risk factors for ACL injury. Understanding intrinsic and extrinsic factors which contribute to movement patterns is critical to ACL injury prevention efforts. Isometric lower- extremity muscular strength, anthropometrics, and jump-landing technique were analyzed for 2,753 cadets (1,046 female, 1,707 male from the U.S. Air Force, Military and Naval Academies. Jump- landings were evaluated using the Landing Error Scoring System (LESS, a valid qualitative movement screening tool. We hypothesized that distinct anthropometric factors (Q-angle, navicular drop, bodyweight and muscle strength would predict poor jump-landing technique in males versus females, and that female cadets would have higher scores (more errors on a qualitative movement screen (LESS than males. Mean LESS scores were significantly higher in female (5.34 ± 1.51 versus male (4.65 ± 1.69 cadets (p < 0.001. Qualitative movement scores were analyzed using factor analyses, yielding five factors, or "patterns", contributing to poor landing technique. Females were significantly more likely to have poor technique due to landing with less hip and knee flexion at initial contact (p < 0.001, more knee valgus with wider landing stance (p < 0. 001, and less flexion displacement over the entire landing (p < 0.001. Males were more likely to have poor technique due to landing toe-out (p < 0.001, with heels first, and with an asymmetric foot landing (p < 0.001. Many of the identified factor patterns have been previously proposed to contribute to ACL injury risk. However, univariate and multivariate analyses of muscular strength and anthropometric factors did not strongly predict LESS scores for either gender, suggesting that changing an athlete's alignment, BMI, or muscle strength may not directly improve his or her movement patterns

  20. PECULIARITIES OF TRAINING AND EDUCATION OF CADETS OF MARITIME UNIVERSITIES IN THE FORMER SOVIET REPUBLICS

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    Tomilina S. N.

    2015-11-01

    Full Text Available On the basis of the analysis of documents, publications of scientists and periodical materials we considered particular training and education of cadets and students of maritime educational institutions in the post-Soviet republics. The acquisition of independence by the former Soviet republics demanded the creation and strengthening of their own statehood. The most important task for the newly independent states was the establishment of an effective system of higher professional education (HPE, for the purpose of training national personnel for its own economy. One of the components of HPE for each republic is marine colleges. Establishment of Maritime Universities in those young states has been performed, in a rather short period. The most characteristic of them is a reorientation of the teaching factor of educational activities in the international and European standards. Now the system of training in marine universities meet the requirements of the International Convection on Training and Certification and Watch keeping for Seafarers, as amended, and other international conventions, which gives graduates the right to work on all types of vessels of domestic and foreign shipping companies. Nevertheless, for the process of educating and education of future naval professionals some problems are peculiar related to the lacks of the special and educational literature on national languages, by the shortage of the prepared teachers with experience of swimming on the courts of marine transport, sufficient financing. In educator work with students of marine institutions of higher education, a course is taken on forming patriotism for them, tolerance, volunteering, nationally spiritual values. Practically for every former soviet republic in patriotic education of students it is peculiar to have a specific system, features, but at the same time there are general lines: system, orientation on national traditions, close connection with a defensive

  1. A historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety and efficacy of MonoMax® suture material for abdominal wall closure after primary midline laparotomy. ISSAAC-Trial [NCT005725079

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    Franck Annette

    2008-07-01

    Full Text Available Abstract Background Several randomized controlled trials have compared different suture materials and techniques for abdominal wall closure with respect to the incidence of incisional hernias after midline laparotomy and shown that it remains, irrespective of the methods used, considerably high, ranging from 9% to 20%. The development of improved suture materials which would reduce postoperative complications may help to lower its frequency. Design This is a historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety of MonoMax® suture material for abdominal wall closure in 150 patients with primary elective midline incisions. INSECT patients who underwent abdominal closure using Monoplus® and PDS® will serve as historical control group. The incidences of wound infections and of burst abdomen are defined as composite primary endpoints. Secondary endpoints are the frequency of incisional hernias within one year after operation and safety. To ensure adequate comparability in surgical performance and recruitment, the 4 largest centres of the INSECT-Trial will participate. After hospital discharge, the investigators will examine the enrolled patients again at 30 days and at 12 ± 1 months after surgery. Conclusion This historically controlled, single-arm, multi-centre, prospective ISSAAC trial aims to assess whether the use of an ultra-long-lasting absorbable monofilament suture material is safe and efficient. Trial registration NCT005725079

  2. Safety and immunogenicity of H1/IC31®, an adjuvanted TB subunit vaccine, in HIV-infected adults with CD4+ lymphocyte counts greater than 350 cells/mm3: a phase II, multi-centre, double-blind, randomized, placebo-controlled trial.

    Directory of Open Access Journals (Sweden)

    Klaus Reither

    Full Text Available Novel tuberculosis vaccines should be safe, immunogenic, and effective in various population groups, including HIV-infected individuals. In this phase II multi-centre, double-blind, placebo-controlled trial, the safety and immunogenicity of the novel H1/IC31 vaccine, a fusion protein of Ag85B-ESAT-6 (H1 formulated with the adjuvant IC31, was evaluated in HIV-infected adults.HIV-infected adults with CD4+ T cell counts >350/mm3 and without evidence of active tuberculosis were enrolled and followed until day 182. H1/IC31 vaccine or placebo was randomly allocated in a 5:1 ratio. The vaccine was administered intramuscularly at day 0 and 56. Safety assessment was based on medical history, clinical examinations, and blood and urine testing. Immunogenicity was determined by a short-term whole blood intracellular cytokine staining assay.47 of the 48 randomised participants completed both vaccinations. In total, 459 mild or moderate and 2 severe adverse events were reported. There were three serious adverse events in two vaccinees classified as not related to the investigational product. Local injection site reactions were more common in H1/IC31 versus placebo recipients (65.0% vs. 12.5%, p = 0.015. Solicited systemic and unsolicited adverse events were similar by study arm. The baseline CD4+ T cell count and HIV viral load were similar by study arm and remained constant over time. The H1/IC31 vaccine induced a persistent Th1-immune response with predominately TNF-α and IL-2 co-expressing CD4+ T cells, as well as polyfunctional IFN-γ, TNF-α and IL-2 expressing CD4+ T cells.H1/IC31 was well tolerated and safe in HIV-infected adults with a CD4+ Lymphocyte count greater than 350 cells/mm3. The vaccine did not have an effect on CD4+ T cell count or HIV-1 viral load. H1/IC31 induced a specific and durable Th1 immune response.Pan African Clinical Trials Registry (PACTR PACTR201105000289276.

  3. Greater Heart Rate Responses to Acute Stress Are Associated with Better Post-Error Adjustment in Special Police Cadets.

    Science.gov (United States)

    Yao, Zhuxi; Yuan, Yi; Buchanan, Tony W; Zhang, Kan; Zhang, Liang; Wu, Jianhui

    2016-01-01

    High-stress jobs require both appropriate physiological regulation and behavioral adjustment to meet the demands of emergencies. Here, we investigated the relationship between the autonomic stress response and behavioral adjustment after errors in special police cadets. Sixty-eight healthy male special police cadets were randomly assigned to perform a first-time walk on an aerial rope bridge to induce stress responses or a walk on a cushion on the ground serving as a control condition. Subsequently, the participants completed a Go/No-go task to assess behavioral adjustment after false alarm responses. Heart rate measurements and subjective reports confirmed that stress responses were successfully elicited by the aerial rope bridge task in the stress group. In addition, greater heart rate increases during the rope bridge task were positively correlated with post-error slowing and had a trend of negative correlation with post-error miss rate increase in the subsequent Go/No-go task. These results suggested that stronger autonomic stress responses are related to better post-error adjustment under acute stress in this highly selected population and demonstrate that, under certain conditions, individuals with high-stress jobs might show cognitive benefits from a stronger physiological stress response. PMID:27428280

  4. The impact of radiographer immediate reporting on patient outcomes and service delivery within the emergency department: Designing a randomised controlled trial

    Energy Technology Data Exchange (ETDEWEB)

    Hardy, Maryann, E-mail: M.L.Hardy1@bradford.ac.uk [Division of Radiography, School of Health Studies, University of Bradford, 25 Trinity Road, Bradford, West Yorkshire BD5 0BB (United Kingdom); Snaith, Beverly [Department of Radiology, Mid Yorkshire Hospitals NHS Trust (United Kingdom)

    2011-11-15

    Designing a large research trial to comprehensively evaluate the impact of a service initiative can be daunting but it is not beyond the skills and abilities of radiographers and non-medical professionals. This paper describes the development of a protocol and operational aspects of a multi-centre randomised controlled trial of radiographer immediate reporting. While the focus of the research is specific, the research design stages are transferable and not context dependent and therefore can be applied to different clinical fields. The intention of this paper is to make transparent and explicit the steps in the design and operation of this research and by doing so, offer an objective reflection on each phase of the process to enhance professional understanding of the practicalities of operating a clinical trial.

  5. Study protocol: SPARCLE – a multi-centre European study of the relationship of environment to participation and quality of life in children with cerebral palsy

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    Colver Allan

    2006-04-01

    Full Text Available Abstract Background SPARCLE is a nine-centre European epidemiological research study examining the relationship of participation and quality of life to impairment and environment (physical, social and attitudinal in 8–12 year old children with cerebral palsy. Concepts are adopted from the International Classification of Functioning, Disability and Health which bridges the medical and social models of disability. Methods/Design A cross sectional study of children with cerebral palsy sampled from total population databases in 9 European regions. Children were visited by research associates in each country who had been trained together. The main instruments used were KIDSCREEN, Life-H, Strength and Difficulties Questionnaire, Parenting Stress Index. A measure of environment was developed within the study. All instruments were translated according to international guidelines. The potential for bias due to non response and missing data will be examined. After initial analysis using multivariate regression of how the data captured by each instrument relate to impairment and socio-economic characteristics, relationships between the latent traits captured by the instruments will then be analysed using structural equation modelling. Discussion This study is original in its methods by directly engaging children themselves, ensuring those with learning or communication difficulty are not excluded, and by studying in quantitative terms the crucial outcomes of participation and quality of life. Specification and publication of this protocol prior to analysis, which is not common in epidemiology but well established for randomised controlled trials and systematic reviews, should avoid the pitfalls of data dredging and post hoc analyses.

  6. Commercial weight loss diets meet nutrient requirements in free living adults over 8 weeks: A randomised controlled weight loss trial

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    Macdonald Ian

    2008-09-01

    Full Text Available Abstract Objective To investigate the effect of commercial weight loss programmes on macronutrient composition and micronutrient adequacy over a 2 month period. Design Adults were randomly allocated to follow the Slim Fast Plan, Weight Watchers Pure Points Programme, Dr Atkins' New Diet Revolution, or Rosemary Conley's "Eat Yourself Slim" Diet & Fitness Plan. Setting A multi-centre randomised controlled trial. Subjects 293 adults, mean age 40.3 years and a mean BMI 31.7 (range 27–38 were allocated to follow one of the four diets or control group. Subjects completed a 7-day food and activity diary at baseline (prior to randomisation and after 2 months. Diet records were analysed for nutrient composition using WinDiets (research version. Results A significant shift in the macronutrient composition of the diet with concurrent alteration of the micronutrient profile was apparent with all diets. There was no evidence to suggest micronutrient deficiency in subjects on any of the dietary regimens. However, those sub-groups with higher needs for specific micronutrients, such as folate, iron or calcium may benefit from tailored dietary advice. Conclusion The diets tested all resulted in considerable macronutrient change and resulted in an energy deficit indicating dietary compliance. Health professionals and those working in community and public health should be reassured of the nutritional adequacy of the diets tested. Trial Registration Number NCT00327821

  7. Preventing mood and anxiety disorders in youth: a multi-centre RCT in the high risk offspring of depressed and anxious patients

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    Nauta Maaike H

    2012-04-01

    Full Text Available Abstract Background Anxiety and mood disorders are highly prevalent and pose a huge burden on patients. Their offspring is at increased risk of developing these disorders as well, indicating a clear need for prevention of psychopathology in this group. Given high comorbidity and non-specificity of intergenerational transmission of disorders, prevention programs should target both anxiety and depression. Further, while the indication for preventive interventions is often elevated symptoms, offspring with other high risk profiles may also benefit from resilience-based prevention programs. Method/design The current STERK-study (Screening and Training: Enhancing Resilience in Kids is a randomized controlled clinical trial combining selected and indicated prevention: it is targeted at both high risk individuals without symptoms and at those with subsyndromal symptoms. Individuals without symptoms meet two of three criteria of the High Risk Index (HRI; female gender, both parents affected, history of a parental suicide (attempt. This index was developed in an earlier study and corresponds with elevated risk in offspring of depressed patients. Children aged 8–17 years (n = 204 with subthreshold symptoms or meeting the criteria on the HRI are randomised to one of two treatment conditions, namely (a 10 weekly individual child CBT sessions and 2 parent sessions or (b minimal information. Assessments are held at pre-test, post-test and at 12 and 24 months follow-up. Primary outcome is the time to onset of a mood or anxiety disorder in the offspring. Secondary outcome measures include number of days with depression or anxiety, child and parent symptom levels, quality of life, and cost-effectiveness. Based on models of aetiology of mood and anxiety disorders as well as mechanisms of change during interventions, we selected potential mediators and moderators of treatment outcome, namely coping, parent–child interaction, self-associations, optimism

  8. Surface-induced intramolecular electron transfer in multi-centre redox metalloproteins: the di-haem protein cytochrome c{sub 4} in homogeneous solution and at electrochemical surfaces

    Energy Technology Data Exchange (ETDEWEB)

    Chi Qijin; Zhang Jingdong; Jensen, Palle S; Ulstrup, Jens [Department of Chemistry, Technical University of Denmark, Building 207, DK-2800 Kongens Lyngby (Denmark); Nazmudtinov, Renat R [Kazan State Technological University, 420015 Kazan, Republic of Tatarstan (Russian Federation)

    2008-09-17

    Intramolecular electron transfer (ET) between transition metal centres is a core feature of biological ET and redox enzyme function. The number of microscopic redox potentials and ET rate constants is, however, mostly prohibitive for experimental mapping, but two-centre proteins offer simple enough communication networks for complete mapping to be within reach. At the same time, multi-centre redox proteins operate in a membrane environment where conformational dynamics and ET patterns are quite different from the conditions in a homogeneous solution. The bacterial respiratory di-haem protein Pseudomonas stutzeri cytochrome c{sub 4} offers a prototype target for environmental gating of intra-haem ET. ET between P. stutzeri cyt c{sub 4} and small molecular reaction partners in solution appears completely dominated by intermolecular ET of each haem group/protein domain, with no competing intra-haem ET, for which accompanying propionate-mediated proton transfer is a further barrier. The protein can, however, be immobilized on single-crystal, modified Au(111) electrode surfaces with either the low-potential N terminal or the high-potential C terminal domain facing the surface, clearly with fast intramolecular ET as a key feature in the electrochemical two-ET process. This dual behaviour suggests a pattern for multi-centre redox metalloprotein function. In a homogeneous solution, which is not the natural environment of cyt c{sub 4}, the two haem group domains operate largely independently with conformations prohibitive for intramolecular ET. Binding to a membrane or electrochemical surface, however, triggers conformational opening of intramolecular ET channels. The haem group orientation in P. stutzeri cyt c{sub 4} is finally noted to offer a case for orientation dependent electronic rectification between a substrate and a tip in electrochemical in situ scanning tunnelling microscopy or nanoscale electrode configurations.

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

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    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

  10. GENetic and clinical Predictors Of treatment response in Depression: the GenPod randomised trial protocol

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    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

  11. Effect of exercise on Special Aviation Gymnastics Instruments on blood serum levels of selected biochemical indices in cadets

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    Zbigniew Wochyński

    2014-03-01

    Full Text Available Introduction. Aim of this study was the training effect evaluation on the Special Aviation Gymnastics Instruments (SAGI on blood metallothionein (MT, zinc (Zn, copper (Cu, protein, neuron-specific enolase (NSE, and physical fitness in the examined cadets. Material and methods. The study comprised 55 cadets, aged 20, divided into two groups: examined group A (N=41 and control group B (N=14. In both groups, blood material was collected twice, i.e. before (baseline and after training (series I, during (series II, and after completion of training on the SAGI (Series III. Blood serum MT, Zn, Cu, protein, and NSE were assayed with commercially available kits. Physical fitness was assessed with commonly used fitness tests. Results. A significant decrease in serum MT was noted in both groups in all three series of assays after training, except group B in series II. NSE significantly increased in group A in series II after training. NSE activity increased significantly in group B in series I and III. In both groups, a significant decrease in blood serum Zn was noted after training in series I and II. Serum Cu significantly decreased in group A in all three series of assays. Blood serum protein significantly decreased in group A in series III. In series II, blood serum protein increased significantly in both groups. The remaining values were not changed significantly. Conclusions. Training intensity on SAGI lowered serum MT levels after training in comparison with the control group. This might be associated with Zn, Cu, and protein metabolism.

  12. Fotogrametria na identificação de assimetrias posturais em cadetes e pilotos da academia da força aérea brasileira Photogrammetry on the identification of postural asymmetries in cadets and pilots of the Brazilian air force academy

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    Rodrigo V. Figueiredo

    2012-02-01

    Full Text Available OBJETIVO: Identificar se a atividade de treino de voo pode desencadear alterações posturais em cadetes e pilotos da Academia da Força Aérea Brasileira (AFA. MÉTODOS: Os sujeitos foram avaliados por meio de registro fotográfico em vista anterior e lateral direita, tendo como casuística 80 cadetes da AFA, divididos em quatro grupos, 20 em cada, e 15 pilotos do Esquadrão de Demonstração Aérea (EDA, formando o quinto grupo. As fotos foram transferidas para o Software de Avaliação Postural (SAPO, sendo traçados ângulos relacionados ao alinhamento vertical da cabeça (AVC, alinhamento horizontal da cabeça (AHC, alinhamento horizontal dos acrômios (AHA e alinhamento horizontal das espinhas ilíacas ântero-superiores (AHE. RESULTADOS: Os resultados mostraram que, após comparação das médias das assimetrias posturais entre os grupos, não houve diferença estatisticamente significante em relação aos ângulos AVC, AHC e AHA. No entanto, na variável AHE, observou-se que o grupo de pilotos apresentou valores significativamente menores que os dos cadetes, sugerindo maior estabilidade postural em relação a essa variável. CONCLUSÃO: O AHE foi a única medida que apresentou diferença estatisticamente significate na comparação entre os pilotos e cadetes dos diferentes anos. Quanto aos demais alinhamentos, não houve diferença, podendo atribuir esse fato aos critérios exigentes de ingresso dos cadetes na AFA e a eficiência do treinamento físico realizado periodicamente.OBJECTIVE: To identify whether flight training activities cause postural changes in cadets and pilots of the Brazilian Air Force Academy (AFA. METHODS: Eighty subjects were assessed through photographic images in anterior and right side views. Four groups of cadets (n=20 per group divided according to the year since enlistment and a fifth group of fifteen pilots from the Air Demonstration Squadron (ADS were included. Pictures were analyzed using the Postural

  13. 浅谈军校学员学术论文选题%A Brief Discussion on Cadets' Topic Selection for Aca-demic Papers

    Institute of Scientific and Technical Information of China (English)

    管龙娟

    2016-01-01

    军校学员在学术论文的写作过程中经常出现选题失误、论点陈旧的问题.为了尽量避免这些问题,学员在选题时应采取以下对策:力求小巧,便于深入;知己知彼,量力而行;勤于思考,刻意求新.%Cadets often make mistakes and select antiquated ar-guments in writing academic papers. To avoid these problems as far as possible, cadets should take the following countermeasures in topic selection:striving for small but profound topics;selecting topics in accordance with their own capacities; being diligent in thinking and continuously making innovations.

  14. The Influence of Somatotype Components and Personality Traits on the Playing Position and the Quality of Top Croatian Female Cadet Handball Players

    OpenAIRE

    Čavala, Marijana; Trninić, Viktorija; Jašić, Dajana; Tomljanović, Mario

    2013-01-01

    The research was conducted with the aim to establish the structure and the differences of morphological features and personality traits between different age groups of female cadet handball players grouped by their playing quality and playing positions. Further on, the research was done on 70 handball players aged 15, 31 on average, who were grouped according to their positions on goalkeepers, outside players, wings and pivots. Furthermore, according to the quality of playing, they were divid...

  15. Physical activity as a treatment for depression: the TREAD randomised trial protocol

    Directory of Open Access Journals (Sweden)

    Lawlor Debbie A

    2010-11-01

    Full Text Available Abstract Background Depression is one of the most common reasons for consulting a General Practitioner (GP within the UK. Whilst antidepressants have been shown to be clinically effective, many patients and healthcare professionals would like to access other forms of treatment as an alternative or adjunct to drug therapy for depression. A recent systematic review presented some evidence that physical activity could offer one such option, although further investigation is needed to test its effectiveness within the context of the National Health Service. The aim of this paper is to describe the protocol for a randomised, controlled trial (RCT designed to evaluate an intervention developed to increase physical activity as a treatment for depression within primary care. Methods/design The TREAD study is a pragmatic, multi-centre, two-arm RCT which targets patients presenting with a new episode of depression. Patients were approached if they were aged 18-69, had recently consulted their GP for depression and, where appropriate, had been taking antidepressants for less than one month. Only those patients with a confirmed diagnosis of a depressive episode as assessed by the Clinical Interview Schedule-Revised (CIS-R, a Beck Depression Inventory (BDI score of at least 14 and informed written consent were included in the study. Eligible patients were individually randomised to one of two treatment groups; usual GP care or usual GP care plus facilitated physical activity. The primary outcome of the trial is clinical symptoms of depression assessed using the BDI four months after randomisation. A number of secondary outcomes are also measured at the 4-, 8- and 12-month follow-up points including quality of life, attitude to and involvement in physical activity and antidepressant use/adherence. Outcomes will be analysed on an intention-to-treat (ITT basis and will use linear and logistic regression models to compare treatments. Discussion The results of

  16. A randomised, feasibility trial of a tele-health intervention for Acute Coronary Syndrome patients with depression ('MoodCare': Study protocol

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    Hare David L

    2011-02-01

    Full Text Available Abstract Background Coronary heart disease (CHD and depression are leading causes of disease burden globally and the two often co-exist. Depression is common after Myocardial Infarction (MI and it has been estimated that 15-35% of patients experience depressive symptoms. Co-morbid depression can impair health related quality of life (HRQOL, decrease medication adherence and appropriate utilisation of health services, lead to increased morbidity and suicide risk, and is associated with poorer CHD risk factor profiles and reduced survival. We aim to determine the feasibility of conducting a randomised, multi-centre trial designed to compare a tele-health program (MoodCare for depression and CHD secondary prevention, with Usual Care (UC. Methods Over 1600 patients admitted after index admission for Acute Coronary Syndrome (ACS are being screened for depression at six metropolitan hospitals in the Australian states of Victoria and Queensland. Consenting participants are then contacted at two weeks post-discharge for baseline assessment. One hundred eligible participants are to be randomised to an intervention or a usual medical care control group (50 per group. The intervention consists of up to 10 × 30-40 minute structured telephone sessions, delivered by registered psychologists, commencing within two weeks of baseline screening. The intervention focuses on depression management, lifestyle factors (physical activity, healthy eating, smoking cessation, alcohol intake, medication adherence and managing co-morbidities. Data collection occurs at baseline (Time 1, 6 months (post-intervention (Time 2, 12 months (Time 3 and 24 months follow-up for longer term effects (Time 4. We are comparing depression (Cardiac Depression Scale [CDS] and HRQOL (Short Form-12 [SF-12] scores between treatment and UC groups, assessing the feasibility of the program through patient acceptability and exploring long term maintenance effects. A cost-effectiveness analysis of

  17. DALI: Defining Antibiotic Levels in Intensive care unit patients: a multi-centre point of prevalence study to determine whether contemporary antibiotic dosing for critically ill patients is therapeutic

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    Roberts Jason A

    2012-07-01

    Full Text Available Abstract Background The clinical effects of varying pharmacokinetic exposures of antibiotics (antibacterials and antifungals on outcome in infected critically ill patients are poorly described. A large-scale multi-centre study (DALI Study is currently underway describing the clinical outcomes of patients achieving pre-defined antibiotic exposures. This report describes the protocol. Methods DALI will recruit over 500 patients administered a wide range of either beta-lactam or glycopeptide antibiotics or triazole or echinocandin antifungals in a pharmacokinetic point-prevalence study. It is anticipated that over 60 European intensive care units (ICUs will participate. The primary aim will be to determine whether contemporary antibiotic dosing for critically ill patients achieves plasma concentrations associated with maximal activity. Secondary aims will compare antibiotic pharmacokinetic exposures with patient outcome and will describe the population pharmacokinetics of the antibiotics included. Various subgroup analyses will be conducted to determine patient groups that may be at risk of very low or very high concentrations of antibiotics. Discussion The DALI study should inform clinicians of the potential clinical advantages of achieving certain antibiotic pharmacokinetic exposures in infected critically ill patients.

  18. Current Evidence to Justify, and the Methodological Considerations for a Randomised Controlled Trial Testing the Hypothesis that Statins Prevent the Malignant Progression of Barrett's Oesophagus

    Institute of Scientific and Technical Information of China (English)

    David Thurtle; Leo Alexandre; Yoon K Loke; Ed Cheong; Andrew Hart

    2014-01-01

    Barrett's oesophagus is the predominant risk factor for oesophageal adenocarcinoma, a cancer whose incidence is increasing and which has a poor prognosis. This article reviews the latest experimental and epidemiological evidence justifying the development of a randomised controlled trial investigating the hypothesis that statins prevent the malignant progression of Barrett's oesophagus, and explores the methodological considerations for such a trial. The experimental evidence suggests anti-carcinogenic properties of statins on oesophageal cancer cell lines, based on the inhibition of the mevalonate pathway and the production of pro-apoptotic proteins. The epidemiological evidence reports inverse associations between statin use and the incidence of oesophageal carcinoma in both general population and Barrett's oesophagus cohorts. Such a randomised controlled trial would be a large multi-centre trial, probably investigating simvastatin, given the wide clinical experience with this drug, relatively low side-effect profile and low ifnancial cost. As with any clinical trial, high adherence is important, which could be increased with therapy, patient, doctor and system-focussed interventions. We would suggest there is now sufifcient evidence to justify a full clinical trial that attempts to prevent this aggressive cancer in a high-risk population.

  19. Two-year follow up on nephroptosis in flying cadets%飞行学员肾下垂两年跟踪随访研究

    Institute of Scientific and Technical Information of China (English)

    肖晓光; 郑军; 王继红; 刘淑萍; 周金立; 冯俊岩; 宣萍; 魏磊

    2010-01-01

    目的 观察飞行学员肾下垂随时间的变化情况,为招飞体检时肾下垂医学鉴定标准掌握提供参考. 方法 对招飞体检时肋下可触及肾脏的86名飞行学员(观察组)和随机选择的肋下未触及肾脏的51名学员(对照组)进行跟踪随访,并将观察组按照立位深吸气时是否肋缘下可触及右肾一半以上进一步分为肾下移组(63名)和肾下垂组(23名),观察其在基础学习训练期间的健康状况,两年后复查肾脏触诊和超声检查肾脏位置变化情况,以及有无运动后血尿,对检查结果 进行对比分析. 结果 经过两年学习训练,观察组飞行学员体重增加.超声测量右肾脏下极距右髂后上嵴距离显示:对照组学员肾脏位置无明显变化[(6.0±0.7)cm比(5.9±1.0)cm,t=0.668,P>0.05],肾下移组肾脏位置有所下降[(5.3±1.0)cm比(5.6±0.7)cm,t=2.961,P<0.01],肾下垂组肾脏位置下降更明显[(3.9±0.6)cm比(5.3±0.4)cm,t=10.451,P<0.01].肾下垂组有2名飞行学员出现劳累后腰酸、腰痛等临床症状. 结论 通过两年航空大学常规基础体能训练,肾下移和肾下垂飞行学员肾脏位置没有改善,反而进一步下移,建议招飞体检时应进一步重视肾下垂的检查和医学鉴定,必要时结合超声检查进行评定.%Objective To observe the change of nephroptosis with time in flying cadets and provide references to the evaluation standard of diagnosing nephroptosis in selection of flying cadets.Methods Follow up was taken both for 86 flying cadets with different degree of nephroptosis (observation group) and 51 randomly selected cadets without nephroptosis (control group). The observation group was further divided into kidney descending group ((53 cadets) and nephroptosis group (23 cadets) according to if the half or more kidney could be touched by palpation when cadet was in standing position and holding deep breath. Two years later, kidney palpation and ultrasonic examination were

  20. The third Symptom Management Research Trial in Oncology (SMaRT Oncology-3: a randomised trial to determine the efficacy of adding a complex intervention for major depressive disorder (Depression Care for People with Lung Cancer to usual care, compared to usual care alone in patients with lung cancer

    Directory of Open Access Journals (Sweden)

    Sharpe Michael

    2009-09-01

    Full Text Available Abstract Background Depression Care for People with Lung Cancer is a complex intervention delivered by specially trained cancer nurses, under the supervision of a psychiatrist. It is given as a supplement to the usual care for depression, which patients receive from their general practitioner and cancer service. The third Symptom Management Research Trial in Oncology (SMaRT Oncology-3 Trial will test its efficacy when compared to usual care alone. Design A two arm parallel group multi-centre randomised controlled trial. 200 patients will be recruited through established systematic Symptom Monitoring Services, which screen patients for depression. Patients will have: a diagnosis of lung cancer; an estimated life expectancy of three months or more and a diagnosis of Major Depressive Disorder. Patients will be randomised to usual care or usual care plus Depression Care for People with Lung Cancer. Randomisation will be carried out by telephoning a secure computerised central randomisation system or by using a secure web interface. The primary outcome measure is average depression severity. This will be assessed using scores on the 20-item Symptom Hopkins Checklist (SCL-20D, collected every four weeks over 32 weeks. Secondary outcomes include severity of anxiety, pain and fatigue; self-rated improvement of depression; quality of life and satisfaction with depression care. Trial Registration Current controlled trials ISRCTN75905964

  1. El mantenimiento de la potencia mecánica en tenistas de categoría cadete

    Directory of Open Access Journals (Sweden)

    J. M. Sarabia

    2010-12-01

    Full Text Available

    El objetivo de este estudio fue comprobar la eficiencia de un entrenamiento de fuerza para el tren inferior y superior, basado en el mantenimiento de la potencia mecánica en jugadores cadetes de tenis. 18 tenistas (10 en el grupo experimental y 8 en el grupo control participaron en el estudio. Se realizó un periodo de adaptación anatómica (cinco semanas de duración previo al periodo de intervención en el grupo experimental. El periodo de intervención tuvo una duración de seis semanas donde se trabajó con los ejercicios de bench-press con peso libre y semi-squat en maquina Smith, con una carga estable del 60% de la fuerza dinámica máxima. Se evaluaron previa y posteriormente al periodo de intervención la potencia desarrollada en el tren superior como inferior con diferentes tests, tanto directos como indirectos. Los resultados parecen indicar que la metodología de entrenamiento basada en el mantenimiento de la potencia mecánica es eficiente para la mejora de la potencia máxima, permitiendo una optimización de las sesiones y minimizando el trabajo residual.
    Palabras clave: Fuerza, sobrecarga, fallo mecánico

  2. 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

    attend unblinded assessments at baseline, 3, 6 and 12 months, in addition to their usual care. After the intervention, usual care would be provided. Ethics approval: York Research Ethics Committee (Ref: 01/08/016 approved the study protocol. Discussion We hope the trial will demonstrate feasibility of a pragmatic randomised trial of BITES and help quantify therapeutic effect. A follow up multi-centre trial powered to detect this effect could provide further evidence. Trial registration Current Controlled Trials ISRCTN75807800

  3. Getting the balance right: a randomised controlled trial of physiotherapy and Exercise Interventions for ambulatory people with multiple sclerosis.

    LENUS (Irish Health Repository)

    Coote, Susan

    2009-01-01

    BACKGROUND: People with Multiple Sclerosis have a life long need for physiotherapy and exercise interventions due to the progressive nature of the disease and their greater risk of the complications of inactivity. The Multiple Sclerosis Society of Ireland run physiotherapy, yoga and exercise classes for their members, however there is little evidence to suggest which form of physical activity optimises outcome for people with the many and varied impairments associated with MS. METHODS AND DESIGN: This is a multi-centre, single blind, block randomised, controlled trial. Participants will be recruited via the ten regional offices of MS Ireland. Telephone screening will establish eligibility and stratification according to the mobility section of the Guys Neurological Disability Scale. Once a block of people of the same strand in the same geographical region have given consent, participants will be randomised. Strand A will concern individuals with MS who walk independently or use one stick to walk outside. Participants will be randomised to yoga, physiotherapy led exercise class, fitness instructor led exercise class or to a control group who don\\'t change their exercise habits.Strand B will concern individuals with MS who walk with bilateral support or a rollator, they may use a wheelchair for longer distance outdoors. Participants will be randomised to 1:1 Physiotherapist led intervention, group intervention led by Physiotherapist, group yoga intervention or a control group who don\\'t change their exercise habits. Participants will be assessed by physiotherapist who is blind to the group allocation at week 1, week 12 (following 10 weeks intervention or control), and at 12 week follow up. The primary outcome measure for both strands is the Multiple Sclerosis Impact Scale. Secondary outcomes are Modified Fatigue Impact Scale, 6 Minute Walk test, and muscle strength measured with hand held dynamometry. Strand B will also use Berg Balance Test and the Modified

  4. 'PhysioDirect' telephone assessment and advice services for physiotherapy: protocol for a pragmatic randomised controlled trial

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    Hopper Cherida

    2009-08-01

    Full Text Available Abstract Background Providing timely access to physiotherapy has long been a problem for the National Health Service in the United Kingdom. In an attempt to improve access some physiotherapy services have introduced a new treatment pathway known as PhysioDirect. Physiotherapists offer initial assessment and advice by telephone, supported by computerised algorithms, and patients are sent written self-management and exercise advice by post. They are invited for face-to-face treatment only when necessary. Although several such services have been developed, there is no robust evidence regarding clinical and cost-effectiveness, nor the acceptability of PhysioDirect. Methods/Design This protocol describes a multi-centre pragmatic individually randomised trial, with nested qualitative research. The aim is to determine the effectiveness, cost-effectiveness, and acceptability of PhysioDirect compared with usual models of physiotherapy based on patients going onto a waiting list and receiving face-to-face care. PhysioDirect services will be established in four areas in England. Adult patients in these areas with musculoskeletal problems who refer themselves or are referred by a primary care practitioner for physiotherapy will be invited to participate in the trial. About 1875 consenting patients will be randomised in a 2:1 ratio to PhysioDirect or usual care. Data about outcome measures will be collected at baseline and 6 weeks and 6 months after randomisation. The primary outcome is clinical improvement at 6 months; secondary outcomes include cost, waiting times, time lost from work and usual activities, patient satisfaction and preference. The impact of PhysioDirect on patients in different age-groups and with different conditions will also be examined. Incremental cost-effectiveness will be assessed in terms of quality adjusted life years in relation to cost. Qualitative methods will be used to explore factors associated with the success or failure of

  5. Getting the Balance Right: A randomised controlled trial of physiotherapy and Exercise Interventions for ambulatory people with multiple sclerosis

    Directory of Open Access Journals (Sweden)

    Larkin Aidan

    2009-07-01

    Full Text Available Abstract Background People with Multiple Sclerosis have a life long need for physiotherapy and exercise interventions due to the progressive nature of the disease and their greater risk of the complications of inactivity. The Multiple Sclerosis Society of Ireland run physiotherapy, yoga and exercise classes for their members, however there is little evidence to suggest which form of physical activity optimises outcome for people with the many and varied impairments associated with MS. Methods and design This is a multi-centre, single blind, block randomised, controlled trial. Participants will be recruited via the ten regional offices of MS Ireland. Telephone screening will establish eligibility and stratification according to the mobility section of the Guys Neurological Disability Scale. Once a block of people of the same strand in the same geographical region have given consent, participants will be randomised. Strand A will concern individuals with MS who walk independently or use one stick to walk outside. Participants will be randomised to yoga, physiotherapy led exercise class, fitness instructor led exercise class or to a control group who don't change their exercise habits. Strand B will concern individuals with MS who walk with bilateral support or a rollator, they may use a wheelchair for longer distance outdoors. Participants will be randomised to 1:1 Physiotherapist led intervention, group intervention led by Physiotherapist, group yoga intervention or a control group who don't change their exercise habits. Participants will be assessed by physiotherapist who is blind to the group allocation at week 1, week 12 (following 10 weeks intervention or control, and at 12 week follow up. The primary outcome measure for both strands is the Multiple Sclerosis Impact Scale. Secondary outcomes are Modified Fatigue Impact Scale, 6 Minute Walk test, and muscle strength measured with hand held dynamometry. Strand B will also use Berg Balance Test

  6. The DAMASK trial protocol: a pragmatic randomised trial to evaluate whether GPs should have direct access to MRI for patients with suspected internal derangement of the knee

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    Orchard Jo

    2006-10-01

    Full Text Available Abstract Background Though new technologies like Magnetic Resonance Imaging (MRI may be accurate, they often diffuse into practice before thorough assessment of their value in diagnosis and management, and of their effects on patient outcome and costs. MRI of the knee is a common investigation despite concern that it is not always appropriate. There is wide variation in general practitioners (GPs access to, and use of MRI, and in the associated costs. The objective of this study was to resolve uncertainty whether GPs should refer patients with suspected internal derangement of the knee for MRI or to an orthopaedic specialist in secondary care. Methods/Design The design consisted of a pragmatic multi-centre randomised trial with two parallel groups and concomitant economic evaluation. Patients presenting in general practice with suspected internal derangement of the knee and for whom their GP was considering referral to an orthopaedic specialist in secondary care were eligible for inclusion. Within practices, GPs or practice nurses randomised eligible and consenting participants to the local radiology department for an MRI examination, or for consultation with an orthopaedic specialist. To ensure that the waiting time from GP consultation to orthopaedic appointment was similar for both trial arms, GPs made a provisional referral to orthopaedics when requesting the MRI examination. Thus we evaluated the more appropriate sequence of events independent of variations in waiting times. Follow up of participants was by postal questionnaires at six, twelve and 24 months after randomisation. This was to ensure that the evaluation covered all events up to and including arthroscopy. Discussion The DAMASK trial should make a major contribution to the development of evidence-based partnerships between primary and secondary care professionals and inform the debate when MRI should enter the diagnostic pathway.

  7. Identificação das variáveis preditoras académicas no desenvolvimento de competências de Liderança do cadete aluno de Infantaria

    OpenAIRE

    Ferraz, Nuno

    2015-01-01

    Este trabalho de investigação, intitulado com o tema “ Identificação das variáveis preditoras académicas no desenvolvimento de competências de liderança do Cadete Aluno de Infantaria”, tem como finalidade identificar quais as áreas científicas/pilares tradicionais da Academia Militar que mais contribuem para o desenvolvimento de competências de liderança no Cadete e Aspirante Aluno a fim de colmatar falhas existente na formação dos futuros oficiais do Qu...

  8. The influence of somatotype components and personality traits on the playing position and the quality of top Croatian female cadet handball players.

    Science.gov (United States)

    Cavala, Marijana; Trninić, Viktorija; Jasić, Dajana; Tomljanović, Mario

    2013-05-01

    The research was conducted with the aim to establish the structure and the differences of morphological features and personality traits between different age groups of female cadet handball players grouped by their playing quality and playing positions. Further on, the research was done on 70 handball players aged 15, 31 on average, who were grouped according to their positions on goalkeepers, outside players, wings and pivots. Furthermore, according to the quality of playing, they were divided in two quality groups of players, those from the wider cadet national team, thus characterised as top female players in Croatia, and those who had never been invited into the cadet national team and thus can be referred to as low-quality, i.e. average female handball players. The structure of predictor variables has indicated the existence of general morphological factor assessing the players' constitution and two personality features factors - neuroticism and extraversion. The variance analysis showed no statistically significant differences of somatotype variables with relation to quality and playing position. By observing basic personality traits, a statistically significant difference was confirmed only in introversion-extraversion with a lower score in goalkeepers than in other positions, which indicates a higher level of introversion in this playing position. Such result was expected since this particular position abounds in specific tasks and demands in the game in relation to all other playing positions. Further on, it has been concluded that the selection of players must not be based only on the stated physical and psychological characteristics, but on relevant anthropological complexes determining performance and sport achievement. PMID:23914494

  9. THEORETICAL-METHODOLOGICAL SUBSTANTIATION OF THE PROCESS OF FORMATION OF CIVIL POSITION OF CADETS OF EDUCATIONAL INSTITUTIONS OF RUSSIAN FEDERAL PENITENTIARY SERVICE

    Directory of Open Access Journals (Sweden)

    A. Yu. KUZHEKOV

    2016-01-01

    Full Text Available The article is devoted to the moral and legal education of cadets of educational institutions of the Federal Penitentiary Service of Russia as the main tool for shaping their sustainable citizenship. The author touches upon the historical aspects of the problem, it is concluded that the traditional means of education suppressed personality, being based on the authoritarian nature of the pedagogical relationship. It is stated  that the timely realization of studying the essence of the unity of the content of morality and law, what is happening on the emotional and rational levels, contributes to the disparate mix of individual knowledge and understanding of the complex moral and legal convictions. The author notes that the effectiveness of the process of formation of civil position effectively revealed through strategic (compliance with the rules of interaction of teachers, students, parents on the humanization of life educational organization, ensuring their joint moral and legal activities, the practical organization of students of life and especially tactical objectives (performance cadets duties at the university and outside it, the protection of their rights and freedoms, the practical organization of joint activities in the dyad "teacher-student", their interaction analysis in the organization of events on legal education, compliance with the established rules and standards in the development of university traditions, ways to overcome the stereotype of no confidence moral and legal education of cadets. The author concludes that the presented theoretical and methodological structure of the study will provide the necessary empirical basis of research and will be a guarantee of its effectiveness and usefulness. 

  10. TIPIT: A randomised controlled trial of thyroxine in preterm infants under 28 weeks' gestation

    Directory of Open Access Journals (Sweden)

    Victor Suresh

    2008-03-01

    Full Text Available Abstract Background Infants born at extreme prematurity (below 28 weeks' gestation are at high risk of developmental disability. A major risk factor for disability is having a low level of thyroid hormone which is recognised to be a frequent phenomenon in these infants. At present it is unclear whether low levels of thyroid hormone are a cause of disability, or a consequence of concurrent adversity. Methods We propose an explanatory multi-centre double blind 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 outcome will be brain growth. This will be assessed by the width of the sub-arachnoid space measured using cranial ultrasound and head circumference at 36 weeks' corrected gestational. The secondary outcomes will be (a thyroid hormone concentrations measured at increasing postnatal age, (b status of the hypothalamic pituitary axis, (c auxological data between birth and 36 weeks' corrected gestational age, (d thyroid gland volume, (e volumes of brain structures (measured by magnetic resonance imaging, (f determination of the extent of myelination and white matter integrity (measured by diffusion weighted MRI and brain vessel morphology (measured by magnetic resonance angiography at expected date of delivery and (g markers of morbidity including duration of mechanical ventilation and chronic lung disease. We will also examine how activity of the hypothalamic-pituitary-adrenal axis modulates the effects of thyroid supplementation. This will contribute to decisions about which confounding variables to assess in large-scale studies. Trial registration Current Controlled Trials ISRCTN89493983

  11. Recruitment and retention in a multicentre randomised controlled trial in Bell's palsy: A case study

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    Daly Fergus

    2007-03-01

    Full Text Available Abstract Background It is notoriously difficult to recruit patients to randomised controlled trials in primary care. This is particularly true when the disease process under investigation occurs relatively infrequently and must be investigated during a brief time window. Bell's palsy, an acute unilateral paralysis of the facial nerve is just such a relatively rare condition. In this case study we describe the organisational issues presented in setting up a large randomised controlled trial of the management of Bell's palsy across primary and secondary care in Scotland and how we managed to successfully recruit and retain patients presenting in the community. Methods Where possible we used existing evidence on recruitment strategies to maximise recruitment and retention. We consider that the key issues in the success of this study were; the fact that the research was seen as clinically important by the clinicians who had initial responsibility for recruitment; employing an experienced trial co-ordinator and dedicated researchers willing to recruit participants seven days per week and to visit them at home at a time convenient to them, hence reducing missed patients and ensuring they were retained in the study; national visibility and repeated publicity at a local level delivered by locally based principal investigators well known to their primary care community; encouraging recruitment by payment to practices and reducing the workload of the referring doctors by providing immediate access to specialist care; good collaboration between primary and secondary care and basing local investigators in the otolarnygology trial centres Results Although the recruitment rate did not meet our initial expectations, enhanced retention meant that we exceeded our planned target of recruiting 550 patients within the planned time-scale. Conclusion While difficult, recruitment to and retention within multi-centre trials from primary care can be successfully

  12. A randomised controlled trial of a smoking cessation intervention delivered by dental hygienists: a feasibility study

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    Jenkins William

    2007-05-01

    could have in delivering smoking cessation advice. While success may be modest, public health gain would indicate that the dental team should participate in this activity. However, to add to the knowledge-base, a multi-centred randomised controlled trial, utilising biochemical verification would be required to be undertaken.

  13. 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

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    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

  14. Prescription errors in Brazilian hospitals: a multi-centre exploratory survey Erros de prescrição em hospitais brasileiros: um estudo exploratório multicêntrico

    Directory of Open Access Journals (Sweden)

    Adriana Inocenti Miasso

    2009-02-01

    Full Text Available In Brazil, millions of prescriptions do not follow the legal requirements necessary to guarantee the correct dispensing and administration of medication. This multi-centre exploratory study aimed to analyze the appropriateness of prescriptions at four Brazilian hospitals and to identify possible errors caused by inadequacies. The sample consisted of 864 prescriptions obtained at hospital medical clinics in January 2003. Data was collected by three nurse researchers during one week using a standard data sheet that included items about: the type of prescription; legibility; completeness; use of abbreviations; existence of changes and erasures. There were statistically significant differences between incomplete electronic prescriptions at hospital A, and handwritten ones from hospitals C (Ç2 = 12.703 and p No Brasil, milhões de prescrições não apresentam os requisitos legais necessários para garantir a correta dispensação e administração dos medicamentos. Este estudo multicêntrico exploratório objetivou analisar a adequação das prescrições em quatro hospitais brasileiros e identificar eventuais erros causados pelas inadequações. A amostra consistiu de 864 prescrições obtidas nas clínicas médicas dos hospitais em janeiro de 2003. Os dados foram coletados por três enfermeiras durante uma semana através de instrumento estruturado com variáveis sobre: tipo de prescrição; legibilidade; completude; presença de abreviações, alterações e rasuras. Houve diferenças estatisticamente significativas entre prescrição eletrônica no hospital A e manuscritas nos C (Ç2 = 12,703 e p < 0,001 e D (Ç2 = 14,074 e p < 0,001. Abreviações foram usadas em mais de 80% das receitas nos hospitais B, C e D. Alterações foram encontradas em prescrições de todos os hospitais, com níveis mais elevados no B (35,2% e A (25,3%. Este estudo identificou uma série de pontos vulneráveis na fase prescrição dos sistemas de medicação dos

  15. The determination of efficiency of a special obstacle course for training of cadets and rescuers of Public Service of Ukraine on emergency situations

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    Olexandr Baybak

    2016-02-01

    Full Text Available Purpose: to determine directions of the improvement of the educational and training process of cadets and retraining of rescuers of Public Service of Ukraine on emergency situations (PSES for carrying out the search-rescue works in highlands. Material & Methods: the contingent – cadets (25, rescuers (25 and officers (25 of Public Services of Ukraine on emergency situations took part in the research. The following methods are used for the solution of objectives: the theoretical analysis and generalization of scientific and methodical literature, pedagogical methods of research (poll and questioning. Results: the main requirements to a special obstacle course were defined on the basis of studying and analysis of biographical particulars with the purpose of the improvement of rescuers of PSES for carrying out the search-rescue works (SRW during the emergency situations (ES of a natural character. Conclusions: the need of modeling of weather conditions on a special obstacle course is defined for the purpose of the improvement of the level of preparedness of staff of the search-rescue groups in highlands.

  16. Nursing care intervention in group vaccination of military cadets%军校学员群体预防接种的护理干预

    Institute of Scientific and Technical Information of China (English)

    郑永玲

    2013-01-01

    目的 调查系统护理干预在军校学员群体预防接种的方法和作用.方法 将实施预防接种系统护理干预前后的1 800名学员分为两组:未干预组(875人)和干预组(925人),比较接种效果.结果 通过系统护理干预,学员接种后的不良反应明显减少.结论 护理干预可显著提高学员群体预防接种的安全性和接种效果.%OBJECTIVE To investigate methods and role of systematic nursing care intervention in group vaccination of military cadets.METHODS Based on the systematic nursing care intervention of the immunization,1 800 military cadets were divided into non-intervention group (875 people) and intervention group (925 People) and compared vaccination effect.RESULTS After the systematic nursing care intervention of vaccination,side effect of vaccination reduced obviously.CONCLUSION Nursing care intervention can improve the safety of group vaccination and the effect of vaccination obviously.

  17. Application Analysis of Cadet Self-management Strategies%军校学员自我管理策略应用分析

    Institute of Scientific and Technical Information of China (English)

    戴文婕

    2011-01-01

    Self-management refers to the student first set and clear objectives,establishing a variety of steps;then,students observe their work,record their own behavior and evaluate their own performance;finally be able to select and implement enhanced.This paper puts forward the significance of self-management of cadets,which explains how to achieve the self-management strategies in the process of learning,takes emphasis on the problems cadets should pay attention to in achieving self-management.%自我管理是指学员首先要设置和明确目标,确立各种步骤;然后,学员观察自己的工作、记录自己的行为和评价自己的成绩;最后能够选择和执行强化。本文提出了军校学员自我管理的意义,其中阐述了如何在学习过程中实现军校学员自我管理策略,着重强调了实现军校学员自我管理应注意的问题。

  18. THE RELATIONSHIP BETWEEN ANTHROPOMETRIC PARAMETERS, BODY COMPOSITION AND EXPLOSIVE POWER IN CADET WRESTLERS [Sootnosheniia mezhdu antropometricheskimi parametrami, sostavom tela i vzryvnoj siloj iunykh borcov

    Directory of Open Access Journals (Sweden)

    Bahman Mirzaei Mirzaei

    2011-11-01

    Full Text Available Purpose: The purpose of the present study was to investigate the relationship between anthropometric parameters, body composition and explosive power in cadet wrestlers. Methods: Seventeen male cadet wrestlers (age = 15.6 +/- 0.73 yrs from the Kurdistan province wrestling clubs participated in this study. Body composition (percent body fat, anthropometric parameters (height, sitting height, arm-span, upper arm length, leg length, upper leg length, arm circumference, middle thigh and calf circumference, explosive power (standing long jump and Medicine ball throw tests were measured. Results: Explosive power of upper body was significantly correlated with sitting height arm-span, upper arm length, arm circumference, weight and %BF. Explosive power of lower body was significantly correlated with sitting height, arm-span and weight. No significant correlation was found between explosive power of lower body and leg length, upper leg length, middle thigh circumference and maximum calf circumference Explosive power of upper body was also significantly correlated with explosive power of lower body. Conclusion: Explosive power is an important parameter in wrestling. Having a high level of power along with an appropriate arm-span helps to the wrestler for performing techniques successfully in competition. Our study suggested that height isn't the only parameter affecting talent identification and other parameters such as arm span and sitting height should be seriously considered when criteria for the selection of a wrestler are set.

  19. 1002名医学院校学员蠕形螨感染情况调查分析%Investigation and analysis on vermiform mite infestation of 1002 medical cadets

    Institute of Scientific and Technical Information of China (English)

    杨新华; 高秋菊; 王昭英; 王红; 赵美玲; 傅占江; 孙晓丽; 王沛; 李强

    2014-01-01

    Objective To investigate vermiform mite infestation of medical cadets and analyze the infestation cause .Methods One thousand and two medical cadets were investigated , using transparent bakelized paper .Etiological tests were based on nymphs or prosopons seen in the tests under microscope .Results The total infestation rate was 27.45%,among which the low-grade infestation rate was 96.36%and the positive vermiform mite infestation rate with face acnes was higher than the rate of cadets without face acnes ( P 0.05) in the genders of cadets , infestation parts of the body ,the kinds of infection ,the places where cadets came form , the time when cadets entered the college and their majors .Conclusion The vermiform mite infestation of cadets is related to many factors and the preventive measures should be taken in many aspects .%目的:分析医学院校学员蠕形螨感染情况及其原因。方法以1002名医学院校学员为调研对象,用透明胶纸粘贴法获取标本,以镜检全片查到若虫或成虫为确诊依据。结果蠕形螨总感染率为27.45%,其中轻度感染占96.36%;面部有痤疮学员蠕形螨阳性率50.70%,高于面部皮肤正常者的21.09%( P <0.01);不同集体感染情况之间差异有统计学意义( P <0.01);经常使用化妆品的学员感染率为33.20%,高于未使用化妆品学员的22.05%( P <0.01);蠕形螨感染率在不同性别、不同感染部位、蠕形螨虫种、不同地域、不同入学时间、不同专业等方面差异均无统计学意义( P >0.05)。结论医学院校学员蠕形螨感染与多种因素有关,应从多方面入手采取预防措施。

  20. Whole brain radiotherapy after local treatment of brain metastases in melanoma patients - a randomised phase III trial

    International Nuclear Information System (INIS)

    Cerebral metastases are a common cause of death in patients with melanoma. Systemic drug treatment of these metastases is rarely effective, and where possible surgical resection and/or stereotactic radiosurgery (SRS) are the preferred treatment options. Treatment with adjuvant whole brain radiotherapy (WBRT) following neurosurgery and/or SRS is controversial. Proponents of WBRT report prolongation of intracranial control with reduced neurological events and better palliation. Opponents state melanoma is radioresistant; that WBRT yields no survival benefit and may impair neurocognitive function. These opinions are based largely on studies in other tumour types in which assessment of neurocognitive function has been incomplete. This trial is an international, prospective multi-centre, open-label, phase III randomised controlled trial comparing WBRT to observation following local treatment of intracranial melanoma metastases with surgery and/or SRS. Patients aged 18 years or older with 1-3 brain metastases excised and/or stereotactically irradiated and an ECOG status of 0-2 are eligible. Patients with leptomeningeal disease, or who have had previous WBRT or localised treatment for brain metastases are ineligible. WBRT prescription is at least 30 Gy in 10 fractions commenced within 8 weeks of surgery and/or SRS. Randomisation is stratified by the number of cerebral metastases, presence or absence of extracranial disease, treatment centre, sex, radiotherapy dose and patient age. The primary endpoint is the proportion of patients with distant intracranial failure as determined by MRI assessment at 12 months. Secondary end points include: survival, quality of life, performance status and neurocognitive function. Accrual to previous trials for patients with brain metastases has been difficult, mainly due to referral bias for or against WBRT. This trial should provide the evidence that is currently lacking in treatment decision-making for patients with melanoma brain

  1. Study protocol for a pragmatic randomised controlled trial in general practice investigating the effectiveness of acupuncture against migraine

    Directory of Open Access Journals (Sweden)

    Carbrera-Iboleón Justo

    2008-04-01

    Full Text Available Abstract Background Migraine is a chronic neurologic disease that can severely affect the patient's quality of life. Although in recent years many randomised studies have been carried out to investigate the effectiveness of acupuncture as a treatment for migraine, it remains a controversial issue. Our aim is to determine whether acupuncture, applied under real conditions of clinical practice in the area of primary healthcare, is more effective than conventional treatment. Methods/Design The design consists of a pragmatic multi-centre, three-armed randomised controlled trial, complemented with an economic evaluation of the results achieved, comparing the effectiveness of verum acupuncture with sham acupuncture, and with a control group receiving normal care only. Patients eligible for inclusion will be those presenting in general practice with migraine and for whom their General Practitioner (GP is considering referral for acupuncture. Sampling will be by consecutive selection, and by randomised allocation to the three branches of the study, in a centralised way following a 1:1:1 distribution (verum acupuncture; sham acupuncture; conventional treatment. Secondly, one patient in three will be randomly selected from each of the acupuncture (verum or sham groups for a brain perfusion study (by single photon emission tomography. The treatment with verum acupuncture will consist of 8 treatment sessions, once a week, at points selected individually by the acupuncturist. The sham acupuncture group will receive 8 sessions, one per week, with treatment being applied at non-acupuncture points in the dorsal and lumbar regions, using the minimal puncture technique. The control group will be given conventional treatment, as will the other two groups. Discussion This trial will contribute to available evidence on acupuncture for the treatment of migraine. The primary endpoint is the difference in the number of days with migraine among the three groups, between

  2. 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

  3. 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...

  4. 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 ...

  5. Is computer aided detection (CAD cost effective in screening mammography? A model based on the CADET II study

    Directory of Open Access Journals (Sweden)

    Wallis Matthew G

    2011-01-01

    Full Text Available Abstract Background Single reading with computer aided detection (CAD is an alternative to double reading for detecting cancer in screening mammograms. The aim of this study is to investigate whether the use of a single reader with CAD is more cost-effective than double reading. Methods Based on data from the CADET II study, the cost-effectiveness of single reading with CAD versus double reading was measured in terms of cost per cancer detected. Cost (Pound (£, year 2007/08 of single reading with CAD versus double reading was estimated assuming a health and social service perspective and a 7 year time horizon. As the equipment cost varies according to the unit size a separate analysis was conducted for high, average and low volume screening units. One-way sensitivity analyses were performed by varying the reading time, equipment and assessment cost, recall rate and reader qualification. Results CAD is cost increasing for all sizes of screening unit. The introduction of CAD is cost-increasing compared to double reading because the cost of CAD equipment, staff training and the higher assessment cost associated with CAD are greater than the saving in reading costs. The introduction of single reading with CAD, in place of double reading, would produce an additional cost of £227 and £253 per 1,000 women screened in high and average volume units respectively. In low volume screening units, the high cost of purchasing the equipment will results in an additional cost of £590 per 1,000 women screened. One-way sensitivity analysis showed that the factors having the greatest effect on the cost-effectiveness of CAD with single reading compared with double reading were the reading time and the reader's professional qualification (radiologist versus advanced practitioner. Conclusions Without improvements in CAD effectiveness (e.g. a decrease in the recall rate CAD is unlikely to be a cost effective alternative to double reading for mammography screening

  6. 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

  7. A national multi-centre study of accuracy of hand hygiene of health care workers in ICUs%全国多中心ICU医务人员手卫生正确性分析

    Institute of Scientific and Technical Information of China (English)

    徐丹慧; 吴安华; 胡必杰; 徐英春; 张秀月; 侯铁英; 宗志勇; 李卫光; 杨怀

    2015-01-01

    目的 了解我国ICU医务人员手卫生的正确性 ,为进一步改善手卫生正确性提供科学依据.方法 2013年10月-2014年9月采用多中心研究的方式 ,选取全国47所医院共66个ICU ,使用统一的调查表 ,依据《医务人员手卫生规范》进行判定 ,每月对医务人员手卫生正确性进行调查 ;所有数据录入 EXCEL表格 ,应用SPSS 17 .0进行统计分析.结果 47所医院医务人员手卫生正确率为83 .48% ;其中华东地区的手卫生正确率最高89 .08% ;内科ICU医务人员手卫生正确率最高89 .05% ,其他ICU最低为67 .34% ;2013年第四季度医务人员手卫生正确率最低52 .83% ,2014年手卫生正确率提升较多且较稳定.结论 我国在不同地区、不同ICU类型、不同季度的医务人员手卫生正确率存在差异 ,医务人员手卫生正确性水平仍有可提升的空间 ,需在重点科室、重点环节加强手卫生管理.%OBJECTIVE To investigate the accuracy of hand hygiene of the health care workers in ICUs so as to pro-vide scientific basis for further improvement of accuracy of hand hygiene .METHODS A multi-centre study was con-ducted from Oct 2013 to Sep 2014 ,totally 66 ICUs from 47 hospitals were included in the study ,the uniform questionnaire was adopted ,and the accuracy of hand hygiene of the health care workers was investigated every month according to the Medical Personnel Hand Hygiene Norms .All of the data were input into the EXCEL ta-ble ,and the statistical analysis was performed with the use of SPSS 17 .0 software .RESULTS The rate of correct hand hygiene of the health care workers from 47 hospitals was 83 .48% ,and the rate of correct hand hygiene of the health care workers from the hospitals in eastern China was highest (89 .08% );the rate of correct hand hygiene was highest (89 .05% ) among the health care workers from the ICUs of internal medicine departments and was lowest (67 .34% ) among the health care workers from the ICUs of

  8. Psycho-education with problem solving (PEPS therapy for adults with personality disorder: A pragmatic multi-site community-based randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Duggan Conor

    2011-08-01

    Full Text Available Abstract Background Impairment in social functioning is a key component of personality disorder. Therefore psycho-education and problem solving (PEPS therapy may benefit people with this disorder. Psycho-education aims to educate, build rapport, and motivate people for problem solving therapy. Problem solving therapy aims to help clients solve interpersonal problems positively and rationally, thereby improving social functioning and reducing distress. PEPS therapy has been evaluated with community adults with personality disorder in an exploratory trial. At the end of treatment, compared to a wait-list control group, those treated with PEPS therapy showed better social functioning, as measured by the Social Functioning Questionnaire (SFQ. A definitive evaluation is now being conducted to determine whether PEPS therapy is a clinically and cost-effective treatment for people with personality disorder Methods This is a pragmatic, two-arm, multi-centre, parallel, randomised controlled clinical trial. The target population is community-dwelling adults with one or more personality disorder, as identified by the International Personality Disorder Examination (IPDE. Inclusion criteria are: Living in the community (including residential or supported care settings; presence of one or more personality disorder; aged 18 or over; proficiency in spoken English; capacity to provide informed consent. Exclusion criteria are: Primary diagnosis of a functional psychosis; insufficient degree of literacy, comprehension or attention to be able to engage in trial therapy and assessments; currently engaged in a specific programme of psychological treatment for personality disorder or likely to start such treatment during the trial period; currently enrolled in any other trial. Suitable participants are randomly allocated to PEPS therapy plus treatment as usual (TAU or TAU only. We aim to recruit 340 men and women. The primary outcome is social functioning as measured

  9. Delivering early care in diabetes evaluation (DECIDE: a protocol for a randomised controlled trial to assess hospital versus home management at diagnosis in childhood diabetes

    Directory of Open Access Journals (Sweden)

    Robling Michael

    2011-01-01

    Full Text Available Abstract Background There is increased incidence of new cases of type 1 diabetes in children younger than 15 years. The debate concerning where best to manage newly diagnosed children continues. Some units routinely admit children to hospital whilst others routinely manage children at home. A Cochrane review identified the need for a large well-designed randomised controlled trial to investigate any significant differences in comprehensive short and long-term outcomes between the two approaches. The DECIDE study will address these knowledge gaps, providing high quality evidence to inform national and international policy and practice. Methods/Design This is a multi-centre randomised controlled trial across eight UK paediatric diabetes centres. The study aims to recruit 240 children newly diagnosed with type 1 diabetes and their parents/carers. Eligible patients (aged 0-17 years will be remotely randomised to either 'hospital' or 'home' management. Parents/carers of patients will also be recruited. Nursing management of participants and data collection will be co-ordinated by a project nurse at each centre. Data will be collected for 24 months after diagnosis; at follow up appointments at 3, 12 and 24 months and every 3-4 months at routine clinic visits. The primary outcome measure is patients' glycosylated haemoglobin (HbA1c at 24 months after diagnosis. Additional measurements of HbA1c will be made at diagnosis and 3 and 12 months later. HbA1c concentrations will be analysed at a central laboratory. Secondary outcome measures include length of stay at diagnosis, growth, adverse events, quality of life, anxiety, coping with diabetes, diabetes knowledge, home/clinic visits, self-care activity, satisfaction and time off school/work. Questionnaires will be sent to participants at 1, 12 and 24 months and will include a questionnaire, developed and validated to measure impact of the diagnosis on social activity and independence. Additional

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

    Directory of Open Access Journals (Sweden)

    Sutton Stephen

    2008-04-01

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

  11. SCOPE1: a randomised phase II/III multicentre clinical trial of definitive chemoradiation, with or without cetuximab, in carcinoma of the oesophagus

    Directory of Open Access Journals (Sweden)

    Staffurth John N

    2011-10-01

    Full Text Available Abstract Background Chemoradiotherapy is the standard of care for patients with oesophageal cancer unsuitable for surgery due to the presence of co-morbidity or extent of disease, and is a standard treatment option for patients with squamous cell carcinoma of the oesophagus. Modern regimens of chemoradiotherapy can lead to significant long-term survival. However the majority of patients will die of their disease, most commonly with local progression/recurrence of their tumours. Cetuximab may overcome one of the principal mechanisms of tumour radio-resistance, namely tumour repopulation, in patients treated with chemoradiotherapy. The purpose of this research is first to determine whether the addition of cetuximab to definitive chemoradiotherapy for treatment of patients with non-metastatic carcinoma of the oesophagus is active (in terms of failure-free rate, safe, and feasible within the context of a multi-centre randomised controlled trial in the UK. If the first stage is successful then the trial will continue to accrue sufficient patients to establish whether the addition of cetuximab to the standard treatment improves overall survival. Methods/Design SCOPE1 is a two arm, open, randomised multicentre Phase II/III trial. Eligible patients will have histologically confirmed carcinoma of the oesophagus and have been chosen to receive definitive chemoradiotherapy by an accredited multidisciplinary team including a specialist Upper GI surgeon. 420 patients will be randomised to receive definitive chemoradiotherapy with or without cetuximab using a 1:1 allocation ratio. During Phase II of the study, the trial will assess safety (toxicity, activity (failure-free rate and feasibility (recruitment rate and protocol dose modifications/delays in 90 patients in the experimental arm. If the experimental arm is found to be active, safe, and feasible by the Independent Data Monitoring Committee then recruitment will continue into Phase III. This second

  12. A randomised controlled trial of early insulin therapy in very low birth weight infants, "NIRTURE" (neonatal insulin replacement therapy in Europe

    Directory of Open Access Journals (Sweden)

    Cornette Luc

    2007-08-01

    Full Text Available Abstract Background Studies in adult intensive care have highlighted the importance of insulin and improved glucose control on survival, with 32% reduction in mortality, 22% reduction in intensive care stay and halving of the incidence of bacteraemia. Very low birth weight infants requiring intensive care also have relative insulin deficiency often leading to hyperglycaemia during the first week of life. The physiological influences on insulin secretion and sensitivity, and the potential importance of glucose control at this time are not well established. However there is increasing evidence that the early postnatal period is critical for pancreatic development. At this time a complex set of signals appears to influence pancreatic development and β cell survival. This has implications both in terms of acute glucose control but also relative insulin deficiency is likely to play a role in poor postnatal growth, which has been associated with later motor and cognitive impairment, and fewer β cells are linked to risk of type 2 diabetes later in life. Methods A multi-centre, randomised controlled trial of early insulin replacement in very low birth weight babies (VLBW, birth weight Trial Registration Current Controlled Trials ISRCTN78428828. EUDRACT Number 2004-002170-34

  13. Strengthening and stretching for rheumatoid arthritis of the hand (SARAH: design of a randomised controlled trial of a hand and upper limb exercise intervention - ISRCTN89936343

    Directory of Open Access Journals (Sweden)

    Adams Jo

    2012-11-01

    Full Text Available Abstract Background Rheumatoid Arthritis (RA commonly affects the hands and wrists with inflammation, deformity, pain, weakness and restricted mobility leading to reduced function. The effectiveness of exercise for RA hands is uncertain, although evidence from small scale studies is promising. The Strengthening And Stretching for Rheumatoid Arthritis of the Hand (SARAH trial is a pragmatic, multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of adding an optimised exercise programme for hands and upper limbs to best practice usual care for patients with RA. Methods/design 480 participants with problematic RA hands will be recruited through 17 NHS trusts. Treatments will be provided by physiotherapists and occupational therapists. Participants will be individually randomised to receive either best practice usual care (joint protection advice, general exercise advice, functional splinting and assistive devices or best practice usual care supplemented with an individualised exercise programme of strengthening and stretching exercises. The study assessors will be blinded to treatment allocation and will follow participants up at four and 12 months. The primary outcome measure is the Hand function subscale of the Michigan Hand Outcome Questionnaire, and secondary outcomes include hand and wrist impairment measures, quality of life, and resource use. Economic and qualitative studies will also be carried out in parallel. Discussion This paper describes the design and development of a trial protocol of a complex intervention study based in therapy out-patient departments. The findings will provide evidence to support or refute the use of an optimised exercise programme for RA of the hand in addition to best practice usual care. Trial registration Current Controlled Trials ISRCTN89936343

  14. The SINS trial: A randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma

    Directory of Open Access Journals (Sweden)

    Armstrong Sarah J

    2010-04-01

    Full Text Available Abstract Background Basal cell carcinoma is the commonest human cancer. Despite increasing incidence it remains poorly researched. While not life threatening it can cause significant cosmetic disfigurement. Imiquimod, a cream which enhances the body's immune response, may help deal with the number of cases that occur in low-risk sites, especially when good cosmetic results and home use without surgery are needed. This study aims 1. To compare excisional surgery with imiquimod cream for nodular or superficial basal cell carcinoma in low risk sites, with respect to 3 year clinical clearance, cost-effectiveness and cosmetic results. 2. To ascertain if certain phenotypic features and gene polymorphisms predict tumour responsiveness to treatment. Methods/Design Five hundred participants with low risk nodular or superficial basal cell carcinoma will be recruited from hospitals to this multi-centre, randomised, parallel group, controlled phase III trial. Treatment in the imiquimod group is for 6 weeks for superficial basal cell carcinoma and 12 weeks for nodular basal cell carcinoma. Both treatment groups are followed up in clinic for 3 years. Primary outcome variable: the proportion of participants with clinical evidence of success (no recurrence at 3 years. The primary outcome will be compared between the two treatment groups. Secondary outcomes include: i clinical success at 1, 2 and 5 years, ii time to first recurrence, iii cosmetic appearance of lesion site after treatment, iv level of pain, and v cost-effectiveness. Safety and tolerability data will also be reported. Discussion This study protocol describes a pragmatic randomised controlled trial which it is hoped will address the above uncertainties. Three-year results will be available towards the end of 2010. Trial registration Meta-register: NCT00066872, Eudract No. 2004-004506-24, ISRCTN48755084.

  15. TIPIT: A randomised controlled trial of thyroxine in preterm infants under 28 weeks gestation: Magnetic Resonance Imaging and Magnetic Resonance Angiography protocol

    Directory of Open Access Journals (Sweden)

    Tietze Anna

    2008-06-01

    Full Text Available Abstract Background Infants born at extreme prematurity are at high risk of developmental disability. A major risk factor for disability is having a low level of thyroid hormone described as hypothyroxinaemia, which is recognised to be a frequent phenomenon in these infants. Derangements of critical thyroid function during the sensitive window in prematurity when early development occurs, may have a range of long term effects for brain development. Further research in preterm infants using neuroimaging techniques will increase our understanding of the specificity of the effects of hypothyroxinaemia 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 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 volume, brain size, volumes of key brain structures, extent of myelination and brain vessel morphology at expected date of delivery and markers of morbidity which include duration of mechanical ventilation and/or oxygen requirement and chronic lung disease. Trial registration Current Controlled Trials ISRCTN89493983

  16. Accelerated partial breast irradiation with multi-catheter brachytherapy: Local control, side effects and cosmetic outcome for 274 patients. Results of the German-Austrian multi-centre trial

    International Nuclear Information System (INIS)

    Background and purpose: To evaluate the safety and effectiveness of accelerated partial breast irradiation (APBI) with multi-catheter brachytherapy. Patients and methods: Between 11/2000 and 04/2005, 274 patients participated. Patients were eligible for APBI if they had histologically confirmed breast cancer, a tumour diameter ≤3 cm, complete resection with clear margins ≥2 mm, negative axillary lymph nodes or singular nodal micro-metastasis, no distant metastases, hormone receptor-positive tumours, and were ≥35 years. Patients were excluded if mammographically they showed a multicentric invasive growth pattern, poorly differentiated tumours, residual diffuse micro-calcifications, extensive intraductal component, or vessel invasion. Median follow-up was 32 months (range; 8-68). Results: The local control rate was 99.3% (272/274), the 3 year-local-recurrence-free survival probability, 99.6%. Peri-operative complications occurred in 5.5% (15/274): 9 (3.3%) experienced implant infection and 6 (2.2%) hematoma. Acute toxicity (Grade 1/2 radio-dermatitis) was seen in 6.6% (18/274). Late side effects ≥ Grade 3 (fibrosis, telangiectasia) occurred in 1.8% (4/274). Cosmetic results were excellent/good in 94% (253/274). Conclusions: This analysis underlined the safety and effectiveness of APBI in a carefully selected subgroup with favourable disease characteristics. Of course, longer follow-up and randomised trials are necessary to conclusively assess the potential of APBI

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

    Directory of Open Access Journals (Sweden)

    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

  18. EXTUBATE: A randomised controlled trial of nasal biphasic positive airway pressure vs. nasal continuous positive airway pressure following extubation in infants less than 30 weeks' gestation: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Victor Suresh

    2011-12-01

    Full Text Available Abstract Background Respiratory distress syndrome remains a significant problem among premature infants. Mechanical ventilation through an endotracheal tube remains the mainstay of respiratory support but may be associated with lung injury and the development of chronic lung disease of prematurity. Efforts are needed to reduce the duration of mechanical ventilation in favour of less invasive forms of respiratory support and to improve rates of successful extubation. Non-invasive respiratory support has been demonstrated to be less injurious to the premature lung. Standard practice is to use nasal continuous positive airway pressure (n-CPAP following extubation to support the baby's breathing. Many clinicians also use nasal biphasic positive airway pressure (n-BiPAP in efforts to improve rates of successful extubation. However, there is currently no evidence that this confers any advantage over conventional nasal continuous positive airway pressure. Methods We propose an unblinded multi-centre randomised trial comparing n-CPAP with n-BiPAP in babies born before 30 weeks' gestation and less than two weeks old. Babies with congenital abnormalities and severe intra-ventricular haemorrhage will be excluded. 540 babies admitted to neonatal centres in England will be randomised at the time of first extubation attempt. The primary aim of this study is to compare the rate of extubation failure within 48 hours following the first attempt at extubation. The secondary aims are to compare the effect of n-BiPAP and n-CPAP on the following outcomes: 1. Maintenance of successful extubation for 7 days post extubation 2. Oxygen requirement at 28 days of age and at 36 weeks' corrected gestational age 3. Total days on ventilator, n-CPAP/n-BiPAP 4. Number of ventilator days following first extubation attempt 5. pH and partial pressure of carbon dioxide in the first post extubation blood gas 6. Duration of hospital stay 7. Rate of abdominal distension requiring

  19. The TOBY Study. Whole body hypothermia for the treatment of perinatal asphyxial encephalopathy: A randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Thoresen Marianne

    2008-04-01

    Full Text Available Abstract Background A hypoxic-ischaemic insult occurring around the time of birth may result in an encephalopathic state characterised by the need for resuscitation at birth, neurological depression, seizures and electroencephalographic abnormalities. There is an increasing risk of death or neurodevelopmental abnormalities with more severe encephalopathy. Current management consists of maintaining physiological parameters within the normal range and treating seizures with anticonvulsants. Studies in adult and newborn animals have shown that a reduction of body temperature of 3–4°C after cerebral insults is associated with improved histological and behavioural outcome. Pilot studies in infants with encephalopathy of head cooling combined with mild whole body hypothermia and of moderate whole body cooling to 33.5°C have been reported. No complications were noted but the group sizes were too small to evaluate benefit. Methods/Design TOBY is a multi-centre, prospective, randomised study of term infants after perinatal asphyxia comparing those allocated to "intensive care plus total body cooling for 72 hours" with those allocated to "intensive care without cooling". Full-term infants will be randomised within 6 hours of birth to either a control group with the rectal temperature kept at 37 +/- 0.2°C or to whole body cooling, with rectal temperature kept at 33–34°C for 72 hours. Term infants showing signs of moderate or severe encephalopathy +/- seizures have their eligibility confirmed by cerebral function monitoring. Outcomes will be assessed at 18 months of age using neurological and neurodevelopmental testing methods. Sample size At least 236 infants would be needed to demonstrate a 30% reduction in the relative risk of mortality or serious disability at 18 months. Recruitment was ahead of target by seven months and approvals were obtained allowing recruitment to continue to the end of the planned recruitment phase. 325 infants were

  20. Temporary epicardial cardiac resynchronisation versus conventional right ventricular pacing after cardiac surgery: study protocol for a randomised control trial

    Directory of Open Access Journals (Sweden)

    Russell Stuart J

    2012-02-01

    Full Text Available Abstract Background Heart failure patients with stable angina, acute coronary syndromes and valvular heart disease may benefit from revascularisation and/or valve surgery. However, the mortality rate is increased- 5-30%. Biventricular pacing using temporary epicardial wires after surgery is a potential mechanism to improve cardiac function and clinical endpoints. Method/design A multi-centred, prospective, randomised, single-blinded, intervention-control trial of temporary biventricular pacing versus standard pacing. Patients with ischaemic cardiomyopathy, valvular heart disease or both, an ejection fraction ≤ 35% and a conventional indication for cardiac surgery will be recruited from 2 cardiac centres. Baseline investigations will include: an electrocardiogram to confirm sinus rhythm and measure QRS duration; echocardiogram to evaluate left ventricular function and markers of mechanical dyssynchrony; dobutamine echocardiogram for viability and blood tests for renal function and biomarkers of myocardial injury- troponin T and brain naturetic peptide. Blood tests will be repeated at 18, 48 and 72 hours. The principal exclusions will be subjects with permanent atrial arrhythmias, permanent pacemakers, infective endocarditis or end-stage renal disease. After surgery, temporary pacing wires will be attached to the postero-lateral wall of the left ventricle, the right atrium and right ventricle and connected to a triple chamber temporary pacemaker. Subjects will be randomised to receive either temporary biventricular pacing or standard pacing (atrial inhibited pacing or atrial-synchronous right ventricular pacing for 48 hours. The primary endpoint will be the duration of level 3 care. In brief, this is the requirement for invasive ventilation, multi-organ support or more than one inotrope/vasoconstrictor. Haemodynamic studies will be performed at baseline, 6, 18 and 24 hours after surgery using a pulmonary arterial catheter. Measurements will be

  1. Evaluation of a community pharmacy-based intervention for improving patient adherence to antihypertensives: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    McDowell Jenny

    2010-02-01

    Full Text Available Abstract Background The majority of patients using antihypertensive medications fail to achieve their recommended target blood pressure. Poor daily adherence with medication regimens and a lack of persistence with medication use are two of the major reasons for failure to reach target blood pressure. There is no single intervention to improve adherence with antihypertensives that is consistently effective. Community pharmacists are in an ideal position to promote adherence to chronic medications. This study aims to test a specific intervention package that could be integrated into the community pharmacy workflow to enable pharmacists to improve patient adherence and/or persistence with antihypertensive medications - Hypertension Adherence Program in Pharmacy (HAPPY. Methods/Design The HAPPY trial is a multi-centre prospective randomised controlled trial. Fifty-six pharmacies have been recruited from three Australian states. To identify potential patients, a software application (MedeMine CVD extracted data from a community pharmacy dispensing software system (FRED Dispense®. The pharmacies have been randomised to either 'Pharmacist Care Group' (PCG or 'Usual Care Group' (UCG. To check for 'Hawthorne effect' in the UCG, a third group of patients 'Hidden Control Group' (HCG will be identified in the UCG pharmacies, which will be made known to the pharmacists at the end of six months. Each study group requires 182 patients. Data will be collected at baseline, three and six months in the PCG and at baseline and six months in the UCG. Changes in patient adherence and persistence at the end of six months will be measured using the self-reported Morisky score, the Tool for Adherence Behaviour Screening and medication refill data. Discussion To our knowledge, this is the first research testing a comprehensive package of evidence-based interventions that could be integrated into the community pharmacy workflow to enable pharmacists to improve patient

  2. Community based yoga classes for type 2 diabetes: an exploratory randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Drincevic Desanka

    2009-02-01

    Full Text Available Abstract Background Yoga is a popular therapy for diabetes but its efficacy is contested. The aim of this study was to explore the feasibility of researching community based yoga classes in Type 2 diabetes with a view to informing the design of a definitive, multi-centre trial Methods The study design was an exploratory randomised controlled trial with in-depth process evaluation. The setting was two multi-ethnic boroughs in London, UK; one with average and one with low mean socio-economic deprivation score. Classes were held at a sports centre or GP surgery. Participants were 59 people with Type 2 diabetes not taking insulin, recruited from general practice lists or opportunistically by general practice staff. The intervention group were offered 12 weeks of a twice-weekly 90-minute yoga class; the control group was a waiting list for the yoga classes. Both groups received advice and leaflets on healthy lifestyle and were encouraged to exercise. Primary outcome measure was HbA1c. Secondary outcome measures included attendance, weight, waist circumference, lipid levels, blood pressure, UKPDS cardiovascular risk score, diabetes-related quality of life (ADDQoL, and self-efficacy. Process measures were attendance at yoga sessions, self-reported frequency of practice between taught sessions, and qualitative data (interviews with patients and therapists, ethnographic observation of the yoga classes, and analysis of documents including minutes of meetings, correspondence, and exercise plans. Results Despite broad inclusion criteria, around two-thirds of the patients on GP diabetic registers proved ineligible, and 90% of the remainder declined to participate. Mean age of participants was 60 +/- 10 years. Attendance at yoga classes was around 50%. Nobody did the exercises regularly at home. Yoga teachers felt that most participants were unsuitable for 'standard' yoga exercises because of limited flexibility, lack of basic fitness, co-morbidity, and lack

  3. Functional exercise after total hip replacement (FEATHER a randomised control trial

    Directory of Open Access Journals (Sweden)

    Monaghan Brenda

    2012-11-01

    Full Text Available Abstract Background Prolonged physical impairments in range of movement, postural stability and walking speed are commonly reported following total hip replacement (THR. It is unclear from the current body of evidence what kind of exercises should be performed to maximize patient function and quality of life. Methods/design This will be a single blind multi centre randomized control trial with two arms. Seventy subjects post primary total hip arthroplasty will be randomized into either an experimental group (n=35, or to a control group (n=35. The experimental group will attend a functional exercise class twice weekly for a six week period from week 12 to week 18 post surgery. The functional exercise group will follow a circuit based functional exercise class supervised by a chartered Physiotherapist. The control group will receive usual care. The principal investigator (BM will perform blinded outcome assessments on all patients using validated measures for pain, stiffness, and function using the Western Ontario and Mc Master Universities Osteoarthritis index (WOMAC. This is the primary outcome measurement tool. Secondary outcome measurements include Quality of life (SF-36, 6 min walk test, Visual Analogue Scale, and the Berg Balance score. The WOMAC score will be collated on day five post surgery and repeated at week twelve and week eighteen. All other measurements will be taken at week 12 and repeated at week eighteen. In addition a blinded radiologist will measure gluteus medius cross sectional area using real time ultrasound for all subjects at week 12 and at week 18 to determine if the functional exercise programme has any effect on muscle size. Discussion This randomised controlled trial will add to the body of evidence on the relationship between muscle size, functional ability, balance, quality of life and time post surgery in patients following total hip arthroplasty. The CONSORT guidelines will be followed to throughout. Ethical

  4. Ankle Injury Management (AIM): design of a pragmatic multi-centre equivalence randomised controlled trial comparing Close Contact Casting (CCC) to Open surgical Reduction and Internal Fixation (ORIF) in the treatment of unstable ankle fractures in patients over 60 years

    OpenAIRE

    Willett, K; Keene, DJ; Morgan, L.; Gray, B.; Handley, R; Chesser, T; Pallister, I; Tutton, E; Knox, C; Lall, R; A. Briggs; Lamb, SE

    2014-01-01

    BACKGROUND: Ankle fractures account for 9% of all fractures with a quarter of these occurring in adults over 60 years. The short term disability and long-term consequences of this injury can be considerable. Current opinion favours open reduction and internal fixation (ORIF) over non-operative treatment (fracture manipulation and the application of a standard moulded cast) for older people. Both techniques are associated with complications but the limited published research indicates higher c...

  5. UVB phototherapy in an outpatient setting or at home: a pragmatic randomised single-blind trial designed to settle the discussion. The PLUTO study

    Directory of Open Access Journals (Sweden)

    van Weelden Huib

    2006-08-01

    Full Text Available Abstract Background Home ultraviolet B (UVB treatment is a much-debated treatment, especially with regard to effectiveness, safety and side effects. However, it is increasingly being prescribed, especially in the Netherlands. Despite ongoing discussions, no randomised research has been performed, and only two studies actually compare two groups of patients. Thus, firm evidence to support or discourage the use of home UVB phototherapy has not yet been obtained. This is the goal of the present study, the PLUTO study (Dutch acronym for "national trial on home UVB phototherapy for psoriasis". Methods We designed a pragmatic randomised single-blind multi-centre trial. This trial is designed to evaluate the impact of home UVB treatment versus UVB phototherapy in a hospital outpatient clinic as to effectiveness, quality of life and cost-effectiveness. In total 196 patients with psoriasis who were clinically eligible for UVB phototherapy were included. Normally 85% of the patients treated with UVB show a relevant clinical response. With a power of 80% and a 0.05 significance level it will be possible to detect a reduction in effectiveness of 15%. Effectiveness will be determined by calculating differences in the Psoriasis Area and Severity Index (PASI and the Self Administered PASI (SAPASI scores. Quality of life is measured using several validated generic questionnaires and a disease-specific questionnaire. Other outcome measures include costs, side effects, dosimetry, concomitant use of medication and patient satisfaction. Patients are followed throughout the therapy and for 12 months thereafter. The study is no longer recruiting patients, and is expected to report in 2006. Discussion In the field of home UVB phototherapy this trial is the first randomised parallel group study. As such, this trial addresses the weaknesses encountered in previous studies. The pragmatic design ensures that the results can be well generalised to the target population

  6. A randomised controlled trial to assess the efficacy of Laparoscopic Uterosacral Nerve Ablation (LUNA in the treatment of chronic pelvic pain: The trial protocol [ISRCTN41196151

    Directory of Open Access Journals (Sweden)

    2003-12-01

    Full Text Available Abstract Background Chronic pelvic pain is a common condition with a major impact on health-related quality of life, work productivity and health care utilisation. The cause of the pain is not always obvious as no pathology is seen in 40–60% of the cases. In the absence of pathology there is no established treatment. The Lee-Frankenhauser sensory nerve plexuses and parasympathetic ganglia in the uterosacral ligaments carry pain from the uterus, cervix and other pelvic structures. Interruption of these nerve trunks by laparoscopic uterosacral nerve ablation (LUNA may alleviate pain. However, the balance of benefits and risks of this intervention have not been reliably assessed. LUNA has, nevertheless, been introduced into practice, although there remains controversy regarding indications for LUNA. Hence, there is an urgent need for a randomised controlled trial to confirm, or refute, any worthwhile effectiveness. The principal hypothesis is that, in women with chronic pelvic pain in whom diagnostic laparoscopy reveals either no pathology or mild endometriosis (AFS score ≤ 5 LUNA alleviates pain and improves life quality at 12 months. Methods/Design The principal objective is to test the hypothesis that in women with chronic pelvic pain in whom diagnostic laparoscopy reveals either no pathology or mild endometriosis (AFS score ≤ 5 LUNA alleviates pain and improves life quality at 12 months. A multi-centre, prospective, randomised-controlled-trial will be carried out with blind assessment of outcomes in eligible consenting patients randomised at diagnostic laparoscopy to LUNA (experimental group or to no pelvic denervation (control group. Postal questionnaires including visual analogue scale for pain (primary outcome, an index of sexual satisfaction and the EuroQoL 5D-EQ instrument (secondary outcomes will be administered at 3, 6 and 12 months. The primary assessment of the effectiveness of LUNA will be from comparison of outcomes at the one

  7. Specific treatment of problems of the spine (STOPS: design of a randomised controlled trial comparing specific physiotherapy versus advice for people with subacute low back disorders

    Directory of Open Access Journals (Sweden)

    Richards Matthew C

    2011-05-01

    Full Text Available Abstract Background Low back disorders are a common and costly cause of pain and activity limitation in adults. Few treatment options have demonstrated clinically meaningful benefits apart from advice which is recommended in all international guidelines. Clinical heterogeneity of participants in clinical trials is hypothesised as reducing the likelihood of demonstrating treatment effects, and sampling of more homogenous subgroups is recommended. We propose five subgroups that allow the delivery of specific physiotherapy treatment targeting the pathoanatomical, neurophysiological and psychosocial components of low back disorders. The aim of this article is to describe the methodology of a randomised controlled trial comparing specific physiotherapy treatment to advice for people classified into five subacute low back disorder subgroups. Methods/Design A multi-centre parallel group randomised controlled trial is proposed. A minimum of 250 participants with subacute (6 weeks to 6 months low back pain and/or referred leg pain will be classified into one of five subgroups and then randomly allocated to receive either physiotherapy advice (2 sessions over 10 weeks or specific physiotherapy treatment (10 sessions over 10 weeks tailored according to the subgroup of the participant. Outcomes will be assessed at 5 weeks, 10 weeks, 6 months and 12 months following randomisation. Primary outcomes will be activity limitation measured with a modified Oswestry Disability Index as well as leg and back pain intensity measured on separate 0-10 Numerical Rating Scales. Secondary outcomes will include a 7-point global rating of change scale, satisfaction with physiotherapy treatment, satisfaction with treatment results, the Sciatica Frequency and Bothersomeness Scale, quality of life (EuroQol-5D, interference with work, and psychosocial risk factors (Orebro Musculoskeletal Pain Questionnaire. Adverse events and co-interventions will also be measured. Data will be

  8. Exercise and manual auricular acupuncture: a pilot assessor-blind randomised controlled trial. (The acupuncture and personalised exercise programme (APEP Trial

    Directory of Open Access Journals (Sweden)

    Hurley D

    2008-03-01

    the data, conditioning on the baseline value. Discussion The results of this study investigating the adjuvant effects of auricular acupuncture to exercise in managing CLBP will be used to inform the design of a future multi-centre randomised controlled trial. Trial Registration Current Controlled Trials ISRCTN94142364.

  9. Thoughts on cultivation of sergeant cadets'management ability%士官学员管理能力培养的思考

    Institute of Scientific and Technical Information of China (English)

    魏俊杰; 张东霞; 赵欣

    2015-01-01

    士官作为基层部队教育管理的骨干力量,其管理能力直接关系到基层的安全稳定和战斗力的提升.通过分析加强士官学员管理能力培养的必要性,从思想认识、课程设置和实践效果等方面指出士官学校在学员管理能力培养上的不足;在此基础上,提出了搞好顶层设计、完善教学内容、丰富实践环节和营造军营环境等建议.%As the backbone of the grassroots units'educational management, sergeants'management ability is directly related to the promotion of the security and stability, and combat effectiveness of the grassroots. By analyzing the necessity of strengthening the cultivation of sergeants'management ability, this article focuses on the drawback on cultivation of cadets'management ability in sergeant academies, with respect to the ideological understanding, curriculum provision and practice effects, based on which, it is suggested to do a good job in the top-level design, improve the teaching contents, enriching the link of practice and build the barracks'environment.

  10. Optimization of cadets bad mood in military academy%浅谈优化军校学员的不良情绪

    Institute of Scientific and Technical Information of China (English)

    叶滢

    2013-01-01

      在新形势下,军校学员身份的特殊性,青年学员很容易产生不良情绪,制约着青年学员在军校中的成长和发展,甚至导致一些违法违纪,非理性事件的发生,影响军校的建设和战斗力的提高。在军校管理中,加强不良情绪优化意识,宣传行之有效的优化方法,引导青年学员保持良好的心理情绪对促进学员的心理健康具有至关重要的作用。%In the new situation, the particularity of cadet identity, young students are prone to negative emotions, restricting the growth and development of young students in the military academy, and even lead to some illegal, irrational events, military construction and combat effectiveness. In the military academy management, strengthen the consciousness of bad mood optimization, optimization method of effective propaganda, guide young students to maintain a good mood is important to promote the students' psychological health.

  11. 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.

  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. Study design and methods of the BoTULS trial: a randomised controlled trial to evaluate the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A

    Directory of Open Access Journals (Sweden)

    Graham Laura

    2008-10-01

    Full Text Available Abstract Background Following a stroke, 55–75% of patients experience upper limb problems in the longer term. Upper limb spasticity may cause pain, deformity and reduced function, affecting mood and independence. Botulinum toxin is used increasingly to treat focal spasticity, but its impact on upper limb function after stroke is unclear. The aim of this study is to evaluate the clinical and cost effectiveness of botulinum toxin type A plus an upper limb therapy programme in the treatment of post stroke upper limb spasticity. Methods Trial design : A multi-centre open label parallel group randomised controlled trial and economic evaluation. Participants : Adults with upper limb spasticity at the shoulder, elbow, wrist or hand and reduced upper limb function due to stroke more than 1 month previously. Interventions : Botulinum toxin type A plus upper limb therapy (intervention group or upper limb therapy alone (control group. Outcomes : Outcome assessments are undertaken at 1, 3 and 12 months. The primary outcome is upper limb function one month after study entry measured by the Action Research Arm Test (ARAT. Secondary outcomes include: spasticity (Modified Ashworth Scale; grip strength; dexterity (Nine Hole Peg Test; disability (Barthel Activities of Daily Living Index; quality of life (Stroke Impact Scale, Euroqol EQ-5D and attainment of patient-selected goals (Canadian Occupational Performance Measure. Health and social services resource use, adverse events, use of other antispasticity treatments and patient views on the treatment will be compared. Participants are clinically reassessed at 3, 6 and 9 months to determine the need for repeat botulinum toxin type A and/or therapy. Randomisation : A web based central independent randomisation service. Blinding : Outcome assessments are undertaken by an assessor who is blinded to the randomisation group. Sample size : 332 participants provide 80% power to detect a 15% difference in treatment

  14. A randomised controlled trial and cost effectiveness study of systematic screening (targeted and total population screening versus routine practice for the detection of atrial fibrillation in the over 65s: (SAFE [ISRCTN19633732

    Directory of Open Access Journals (Sweden)

    Raftery James

    2004-07-01

    Full Text Available Abstract Background Atrial fibrillation (AF has been recognised as an important independent risk factor for thromboembolic disease, particularly stroke for which it provides a five-fold increase in risk. This study aimed to determine the baseline prevalence and the incidence of AF based on a variety of screening strategies and in doing so to evaluate the incremental cost-effectiveness of different screening strategies, including targeted or whole population screening, compared with routine clinical practice, for detection of AF in people aged 65 and over. The value of clinical assessment and echocardiography as additional methods of risk stratification for thromboembolic disease in patients with AF were also evaluated. Methods The study design was a multi-centre randomised controlled trial with a study population of patients aged 65 and over from 50 General Practices in the West Midlands. These purposefully selected general practices were randomly allocated to 25 intervention practices and 25 control practices. GPs and practice nurses within the intervention practices received education on the importance of AF detection and ECG interpretation. Patients in the intervention practices were randomly allocated to systematic (n = 5000 or opportunistic screening (n = 5000. Prospective identification of pre-existing risk factors for AF within the screened population enabled comparison between high risk targeted screening and total population screening. AF detection rates in systematically screened and opportunistically screened populations in the intervention practices were compared to AF detection rate in 5,000 patients in the control practices.

  15. Rationale and design of the Kanyini guidelines adherence with the polypill (Kanyini-GAP study: a randomised controlled trial of a polypill-based strategy amongst Indigenous and non Indigenous people at high cardiovascular risk

    Directory of Open Access Journals (Sweden)

    Usherwood Tim

    2010-08-01

    Full Text Available Abstract Background The Kanyini Guidelines Adherence with the Polypill (Kanyini-GAP Study aims to examine whether a polypill-based strategy (using a single capsule containing aspirin, a statin and two blood pressure-lowering agents amongst Indigenous and non-Indigenous people at high risk of experiencing a cardiovascular event will improve adherence to guideline-indicated therapies, and lower blood pressure and cholesterol levels. Methods/Design The study is an open, randomised, controlled, multi-centre trial involving 1000 participants at high risk of cardiovascular events recruited from mainstream general practices and Aboriginal Medical Services, followed for an average of 18 months. The participants will be randomised to one of two versions of the polypill, the version chosen by the treating health professional according to clinical features of the patient, or to usual care. The primary study outcomes will be changes, from baseline measures, in serum cholesterol and systolic blood pressure and self-reported current use of aspirin, a statin and at least two blood pressure lowering agents. Secondary study outcomes include cardiovascular events, renal outcomes, self-reported barriers to indicated therapy, prescription of indicated therapy, occurrence of serious adverse events and changes in quality-of-life. The trial will be supplemented by formal economic and process evaluations. Discussion The Kanyini-GAP trial will provide new evidence as to whether or not a polypill-based strategy improves adherence to effective cardiovascular medications amongst individuals in whom these treatments are indicated. Trial Registration This trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN126080005833347.

  16. 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....

  17. 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…

  18. 英语演讲与军校学员能力素质培养%English Public Speaking and its Role on Cultivating the Qualities of Cadets

    Institute of Scientific and Technical Information of China (English)

    吕念; 黄晓勤

    2014-01-01

    By integrating English public speaking into the English courses of Military Academy, it can help cadets broaden horizons, es-pecially their knowledge in military field, develop their sound psychology, enhance their critical thinking and communicative ability, all of which are the essential elements of being a qualified officer in the information age. Based on relevant bibliography and personal experi-ence in teaching English Public Speaking in Military Academy, detailed course design is given from the aspects of appreciation, imitation, practice and evaluation.%将英语演讲融入军校大学英语课堂可以有效内化学习动机、拓展知识面、培养思辨能力,塑造创新精神,提高交流能力和军官素质,从而有助于培养军队精英人才。引导和组织学员赏析模仿,自主设计,凝练素材,反复加工,激情表演,互相点评,可切实提高英语综合运用能力。结合文献资料,教学经验和参赛经验,阐述了将演讲教学融入英语课堂的欣赏,模仿,演练和评价的教学模式。

  19. Study on Intrinsic Motivation of Soldier Cadets in Military Academies%关于军校战士学员英语学习内驱力的研究与思考

    Institute of Scientific and Technical Information of China (English)

    刘秀芳; 王德丽

    2011-01-01

    Intrinsic motivation has always been playing a positive and determining role in English learning,especially for soldier cadets in military academies whose English proficiency are quite low.Based on motivation theory,this paper analyzes the factors leading to the lack of intrinsic motivation among soldier cadets and puts some suggestions motivating them in the course of English study.This research can be helpful in improving the teaching efficiency and cultivating military elite talents.%学习内驱力作为直接推动学员主动学习的非智力因素,对学员尤其是基础比较薄弱的战士学员的英语学习起着不容忽视的积极作用。依据学习动机的相关理论,对军校战士学员英语学习内驱力方面存在的问题进行深入分析,并探讨培养和激发学员英语学习内驱力的有效措施。

  20. Characteristic and Guiding Strategy of "Post - 90 s" Cadets Self- awareness Development%“90后”军校学员自我意识发展的特点及其引导策略

    Institute of Scientific and Technical Information of China (English)

    董建平; 黎恋恋; 张峰

    2012-01-01

    健康的自我意识对于培养“90后”军校学员健全的人格、健康的情感和坚强的意志品质具有重要意义。从对自我意识涵义的阐述入手,结合“90后”军校学员的特点,探究其自我意识发展过程中的规律性和存在的问题,并有针对性地提出了引导策略。%The healthy self- awareness has great significance to train the "Post - 90 s"cadets sound personality, healthy e- motion and strong will. From the elaboration of the meaning of self - awareness, the paper combined with the characteristic of the "Post - 90 s"cadets, to explore the regularity of the development process of their self- consciousness and the prob- lems, and put forward some countermeasures to solve it.

  1. A multi-center randomised controlled trial of gatifloxacin versus azithromycin for the treatment of uncomplicated typhoid fever in children and adults in Vietnam.

    Directory of Open Access Journals (Sweden)

    Christiane Dolecek

    Full Text Available BACKGROUND: Drug resistant typhoid fever is a major clinical problem globally. Many of the first line antibiotics, including the older generation fluoroquinolones, ciprofloxacin and ofloxacin, are failing. OBJECTIVES: We performed a randomised controlled trial to compare the efficacy and safety of gatifloxacin (10 mg/kg/day versus azithromycin (20 mg/kg/day as a once daily oral dose for 7 days for the treatment of uncomplicated typhoid fever in children and adults in Vietnam. METHODS: An open-label multi-centre randomised trial with pre-specified per protocol analysis and intention to treat analysis was conducted. The primary outcome was fever clearance time, the secondary outcome was overall treatment failure (clinical or microbiological failure, development of typhoid fever-related complications, relapse or faecal carriage of S. typhi. PRINCIPAL FINDINGS: We enrolled 358 children and adults with suspected typhoid fever. There was no death in the study. 287 patients had blood culture confirmed typhoid fever, 145 patients received gatifloxacin and 142 patients received azithromycin. The median FCT was 106 hours in both treatment arms (95% Confidence Interval [CI]; 94-118 hours for gatifloxacin versus 88-112 hours for azithromycin, (logrank test p = 0.984, HR [95% CI] = 1.0 [0.80-1.26]. Overall treatment failure occurred in 13/145 (9% patients in the gatifloxacin group and 13/140 (9.3% patients in the azithromycin group, (logrank test p = 0.854, HR [95% CI] = 0.93 [0.43-2.0]. 96% (254/263 of the Salmonella enterica serovar Typhi isolates were resistant to nalidixic acid and 58% (153/263 were multidrug resistant. CONCLUSIONS: Both antibiotics showed an excellent efficacy and safety profile. Both gatifloxacin and azithromycin can be recommended for the treatment of typhoid fever particularly in regions with high rates of multidrug and nalidixic acid resistance. The cost of a 7-day treatment course of gatifloxacin is approximately one third of the

  2. The use of a modified, oscillating positive expiratory pressure device reduced fever and length of hospital stay in patients after thoracic and upper abdominal surgery: a randomised trial

    Directory of Open Access Journals (Sweden)

    Xiang-yu Zhang

    2015-01-01

    Full Text Available Question: Does the use of an oscillating positive expiratory pressure (PEP device reduce postoperative pulmonary complications in thoracic and upper abdominal surgical patients? Design: A multi-centre, parallel-group, randomised controlled trial with intention-to-treat analysis, blinding of some outcomes, and concealed allocation. Participants: A total of 203 adults after thoracic or upper abdominal surgery with general anaesthesia. Intervention: Participants in the experimental group used an oscillating PEP device, thrice daily for 5 postoperative days. Both the experimental and control groups received standard medical postoperative management and early mobilisation. Outcome measures: Fever, days of antibiotic therapy, length of hospital stay, white blood cell count, and possible adverse events were recorded for 28 days or until hospital discharge. Results: The 99 participants in the experimental group and 104 in the control group were well matched at baseline and there was no loss to follow-up. Fever affected a significantly lower percentage of the experimental group (22% than the control group (42%, with a RR of 0.56 (95% CI 0.36 to 0.87, NNT 6. Similarly, length of hospital stay was significantly shorter in the experimental group, at 10.7 days (SD 8.1, than in the control group, at 13.3 days (SD 11.1; the mean difference was 2.6 days (95% CI 0.4 to 4.8. The groups did not differ significantly in the need for antibiotic therapy, white blood cell count or total expense of treatment. Conclusion: In adults undergoing thoracic and upper abdominal surgery, postoperative use of an oscillating PEP device resulted in fewer cases of fever and shorter hospital stay. However, antibiotic therapy and total hospital expenses were not significantly reduced by this intervention. Trial registration: NCT00816881. [Zhang X-y, Wang Q, Zhang S, Tan W, Wang Z, Li J (2015 The use of a modified, oscillating positive expiratory pressure device reduced fever and

  3. The ESEP study: Salpingostomy versus salpingectomy for tubal ectopic pregnancy; The impact on future fertility: A randomised controlled trial

    Directory of Open Access Journals (Sweden)

    van Mello Norah M

    2008-06-01

    Full Text Available Abstract Background For most tubal ectopic pregnancies (EP surgery is the treatment of first choice. Whether surgical treatment should be performed conservatively (salpingostomy or radically (salpingectomy in women wishing to preserve their reproductive capacity, is subject to debate. Salpingostomy preserves the tube, but bears the risks of both persistent trophoblast and repeat ipsilateral tubal EP. Salpingectomy, avoids these risks, but leaves only one tube for reproductive capacity. This study aims to reveal the trade-off between both surgical options: whether the potential advantage of salpingostomy, i.e. a better fertility prognosis as compared to salpingectomy, outweighs the potential disadvantages, i.e. persistent trophoblast and an increased risk for a repeat EP. Methods/Design International multi centre randomised controlled trial comparing salpingostomy versus salpingectomy in women with a tubal EP without contra lateral tubal pathology. Hemodynamically stable women with a presumptive diagnosis of tubal EP, scheduled for surgery, are eligible for inclusion. Patients pregnant after in vitro fertilisation (IVF and/or known documented tubal pathology are excluded. At surgery, a tubal EP must be confirmed. Only women with a tubal EP amenable to both interventions and a healthy contra lateral tube are included. Salpingostomy and salpingectomy are performed according to standard procedures of participating hospitals. Up to 36 months after surgery, women will be contacted to assess their fertility status at six months intervals starting form the day of the operation. The primary outcome measure is the occurrence of spontaneous viable intra uterine pregnancy. Secondary outcome measures are persistent trophoblast, repeat EP, all pregnancies including those resulting from IVF and financial costs. The analysis will be performed according to the intention to treat principle. A cost-effectiveness analysis will be performed within a decision

  4. 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

  5. Protocol for the MoleMate™ UK Trial: a randomised controlled trial of the MoleMate system in the management of pigmented skin lesions in primary care [ISRCTN 79932379

    Directory of Open Access Journals (Sweden)

    Wilson Edward CF

    2010-05-01

    Full Text Available Abstract Background Suspicious pigmented lesions are a common presenting problem in general practice consultations; while the majority are benign a small minority are melanomas. Differentiating melanomas from other pigmented lesions in primary care is challenging: currently, 95% of all lesions referred to a UK specialist are benign. The MoleMate system is a new diagnostic aid, incorporating a hand-held SIAscopy scanner with a primary care diagnostic algorithm. This trial tests the hypothesis that adding the MoleMate system to current best primary care practice will increase the proportion of appropriate referrals of suspicious pigmented lesions to secondary care compared with current best practice alone. Methods/design The MoleMate UK Trial is a primary care based multi-centre randomised controlled trial, with randomisation at patient level using a validated block randomisation method for two age groups (45 years and under; 46 years and over. We aim to recruit adult patients seen in general practice with a pigmented skin lesion that cannot immediately be diagnosed as benign and the patient reassured. The trial has a 'two parallel groups' design, comparing 'best practice' with 'best practice' plus the MoleMate system in the intervention group. The primary outcome is the positive predictive value (PPV of referral defined as the proportion of referred lesions seen by secondary care experts that are considered 'clinically significant' (i.e. biopsied or monitored. Secondary outcomes include: the sensitivity, specificity and negative predictive value (NPV of the decision not to refer; clinical outcomes (melanoma thickness, 5 year melanoma incidence and mortality; clinician outcomes (Index of Suspicion, confidence, learning effects; patient outcomes (satisfaction, general and cancer-specific worry, and cost-utility. Discussion The MoleMate UK Trial tests a new technology designed to improve the management of suspicious pigmented lesions in primary care

  6. 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

  7. Protocol for a double-blind randomised placebo-controlled trial of lithium carbonate in patients with amyotrophic Lateral Sclerosis (LiCALS [Eudract number: 2008-006891-31

    Directory of Open Access Journals (Sweden)

    Kelly Joanna

    2011-09-01

    Full Text Available Abstract Background Amyotrophic lateral sclerosis is a rapidly progressive neurodegenerative disorder characterised by loss of motor neurons leading to severe weakness and death from respiratory failure within 3-5 years. Riluzole prolongs survival in ALS. A published report has suggested a dramatic effect of lithium carbonate on survival. 44 patients were studied, with 16 randomly selected to take LiCO3 and riluzole and 28 allocated to take riluzole alone. In the group treated with lithium, no patients had died (i.e., 100% survival at the end of the study (15 months from entry, compared to 71% surviving in the riluzole-only group. Although the trial can be criticised on several grounds, there is a substantial rationale from other laboratory studies that lithium is worth investigating therapeutically in amyotrophic lateral sclerosis. Methods/Design LiCALS is a multi-centre double-blind randomised parallel group controlled trial of the efficacy, safety, and tolerability of lithium carbonate (LiCO3 at doses to achieve stable 'therapeutic' plasma levels (0.4-0.8 mmol/L, plus standard treatment, versus matched placebo plus standard treatment, in patients with amyotrophic lateral sclerosis. The study will be based in the UK, in partnership with the MND Association and DeNDRoN (the Dementias and Neurodegnerative Diseases Clinical Research Network. 220 patients will be recruited. All patients will be on the standard treatment for ALS of riluzole 100 mg daily. The primary outcome measure will be death from any cause at 18 months defined from the date of randomisation. Secondary outcome measures will be changes in three functional rating scales, the ALS Functional Rating Scale-Revised, The EuroQOL (EQ-5D, and the Hospital Anxiety and Depression Scale. Eligible patients will have El Escorial Possible, Laboratory-supported Probable, Probable or Definite amyotrophic lateral sclerosis with disease duration between 6 months and 36 months (inclusive, vital

  8. 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...

  9. 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...

  10. 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

  11. 民航某飞行分院飞行学员膳食营养状况%Dietary nutrition survey of flying cadets in a branch of Civil Aviation Flight College

    Institute of Scientific and Technical Information of China (English)

    李岩波

    2013-01-01

    [Objective] To understand the dietary nutritional status of flying cadets,and provide scientific evidence for reasonable adjustment of diet structure and health education.[Methods] The diet structure of flight cadets was investigated by weighing method,meanwhile their nutritional status was evaluated by using BMI in a branch of Civil Aviation Flight College.The nutrition knowledge,behaviors and attitudes of flying cadets in No.6 brigade were investigated by questionnaire.[Results] ①The dietary structure was grain-based,average intake was 532.86 g per person per day,occupying 25.76% of total food,milk intake was a serious shortage.②The daily average intake of energy of flying cadets was 15 281KJ,protein,fat intake exceeded the standard,the intake of vitamin A,vitamin B1 and calcium were inadequate.③Thermal mass source was unreasonable,protein,fat,carbohydrates heat production accounted for 17.71%,33.65%,48.64% of total calories ;④BMI evaluation showed the nutritional status of flying cadets:9 were excess nutrient (8 overweight and 1 obese),the average BMI was (25.86 ± 1.85) kg/m2 ;⑤Questionnaire survey results showed that the nutrition and aviation nutrition knowledge of flying cadets was at a low level,with poor nutrition behavior,but their attitude of nutrition were good.[Conclusion] Suggestions:①Aircrew canteen adds coarse grains in non-flying day,properly adjusts the allocation proportion of animal food in flight day,and increases the intake of milk daily per capita.②The excess nutrientshould adopt effective movement,adjust dietary structure,control and reduce weight.③Many forms of nutrition knowledge and health education should be carried out among aviation workers to improve nutritional awareness of flying cadets,develop and maintain their good behavior and habits of nutrition.%目的 了解飞行学员的膳食营养现况,为合理调整膳食结构,进行健康教育提供科学依据.方法 采用称量法调查分析民航某飞

  12. Protocol for Physiotherapy OR Tvt Randomised Efficacy Trial (PORTRET: a multicentre randomised controlled trial to assess the cost-effectiveness of the tension free vaginal tape versus pelvic floor muscle training in women with symptomatic moderate to severe stress urinary incontinence

    Directory of Open Access Journals (Sweden)

    Buskens Eric

    2009-09-01

    Full Text Available Abstract Background Stress urinary incontinence is a common condition affecting approximately 20% of adult women causing substantial individual (quality of life and economic (119 million Euro/year spent on incontinence pads in the Netherlands burden. Pelvic floor muscle training (PFMT is regarded as first line treatment, but only 15-25% of women will be completely cured. Approximately 65% will report that their condition improved, but long term adherence to treatment is problematic. In addition, at longer term (2-15 years follow-up 30-50% of patients will end up having surgery. From 1996 a minimal invasive surgical procedure, the Tension-free Vaginal Tape (TVT has rapidly become the gold standard in surgical treatment of stress urinary incontinence. With TVT 65-95% of women are cured. However, approximately 3-6% of women will develop symptoms of an overactive bladder, resulting in reduced quality of life. Because of its efficacy the TVT appears to be preferable over PFMT but both treatments and their costs have not been compared head-to-head in a randomised clinical trial. Methods/Design A multi-centre randomised controlled trial will be performed for women between 35 - 80 years old with moderate to severe, predominantly stress, urinary incontinence, who have not received specialised PFMT or previous anti-incontinence surgery. Women will be assigned to either PFMT by a specialised physiotherapist for a standard of 9-18 session in a period of 6 months, or TVT(O surgery. The main endpoint of the study is the subjective improvement of urinary incontinence. As secondary outcome the objective cure will be assessed from history and clinical parameters. Subjective improvement in quality of life will be measured by generic (EQ-5D and disease-specific (Urinary Distress Inventory and Incontinence Impact Questionnaire quality of life instruments. The economical endpoint is short term (1 year incremental cost-effectiveness in terms of costs per additional

  13. Epidemiological survey of dental caries and periodontal disease among the military academy cadets%某军校士官生龋病牙周病流行病学现况调查

    Institute of Scientific and Technical Information of China (English)

    胡媛平; 陈青峰; 许乐; 蒋勇

    2014-01-01

    目的:了解某军校士官生中龋病牙周病患病状况,指导开展口腔健康保健工作。方法参照第3次全国口腔健康流行病学抽样调查方案,采用分层、整群抽样方法选择调查对象,采用SPSS13.0对数据进行统计分析,龋病以患龋率和龋均牙周病以患病率和检出率做为统计指标。结果共调查士官生496名,患龋率为40.12%,龋均为0.89,牙龈炎患病率为24.2%,牙结石检出率为79%,牙周病患病率为5.4%。结论与全军第二次龋病和牙周病监测结果比较患龋率牙结石检出率处于较高水平,应加强对军校士官生的系统性口腔卫生服务。%Objective To survey dental caries and periodontal disease,guiding the oral health care among the military cadets.Methods The scheme of sample survey of the third national oral health investigation of epidemiology used as a reference,we used stratified cluster sampling to select the subjects,and analyzed the data using SPSS 1 3.0.Results Data of 496 military cadets were analyzed.The prevalence rate of dental caries was 40.1 2%,each person had averaged 0.89 caries teeth.The prevalence rate of gingivitis was 24.2%, dental calculus rate was 79%,and periodontitis rate was 5 .4%.Conclusions Compared with the results of all-army second dental de-cay and periodontal disease monitoring,the rate of dental caries and rate of calculus are at higher levels.Systematic dental services are to be further improved for the oral health of the military cadets.

  14. Pregnancy, chimerism and lupus nephritis : a multi-centre study

    NARCIS (Netherlands)

    Hovinga, I. C. L. Kremer; Koopmans, M.; Grootscholten, C.; van der Wal, A. M.; Bijl, M.; Derksen, R. H. W. M.; Voslcuyl, A. E.; de Heer, E.; Bruijn, J. A.; Berden, J. H. M.; Rajema, I. M.

    2008-01-01

    Chimerism occurs twice as often in the kidneys of women with lupus nephritis as in normal kidneys and may he involved in the pathogenesis of systemic lupus erythematosus. Pregnancy is considered the most important source of chimerism, but the exact relationship between pregnancy, the persistence of

  15. Pregnancy, chimerism and lupus nephritis: a multi-centre study.

    NARCIS (Netherlands)

    Hovinga, I.C. Kremer; Koopmans, M.; Grootscholten, C.; Wal, A.M. van der; Bijl, M. van der; Derksen, R.H.; Voskuyl, A.E.; Heer, E. de; Bruijn, J.A.; Berden, J.H.M.; Bajema, I.M.

    2008-01-01

    Chimerism occurs twice as often in the kidneys of women with lupus nephritis as in normal kidneys and may be involved in the pathogenesis of systemic lupus erythematosus. Pregnancy is considered the most important source of chimerism, but the exact relationship between pregnancy, the persistence of

  16. 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-...

  17. 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...

  18. 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

  19. Study on the evaluation and assessment system for the construction of medical selection system of Air Force flying cadets%空军飞行学员医学选拔体系评估指标研究

    Institute of Scientific and Technical Information of China (English)

    马新伟; 焦志刚; 罗永昌

    2016-01-01

    目的 构建飞行学员医学选拔体系评估指标,为完善我国空军飞行学员医学选拔理论和提高勤务组织工作效能提供科学依据. 方法 采用文献调查法、实地调研法和系统分析法,筛选评估指标要素,构建评估指标体系框架.在兼顾专家单位构成、专业构成和其对空军飞行学员医学选拔领域熟悉的基础上,遴选22名咨询专家,包括高级职称19名和机关人员3名.采用德尔菲(Delphi)专家问卷咨询法和层次分析法.按照德尔菲专家咨询要求,开展3轮专家咨询,每轮咨询过程持续25~35 d.根据专家意见和评分结果,对空军飞行学员医学选拔体系评估指标体系框架进行修改完善,确立评估指标体系和各级指标权重. 结果 ①发放调查问卷139份,问卷回收率90.65%,回收问卷有效率89.68%.20世纪80年代中后期以来,我国空军飞行学员医学选拔体系发展迅速,但仍存在组织管理效率低、规章制度不完善、专家队伍建设不合理和装备设备建设滞后等问题.②3轮德尔菲专家咨询问卷回收率分别为90.9%、95.0%和94.7%,协调系数分别为0.543、0.706、0.799,专家意见协调的可信度高(χ2=39.08、50.82、57.53,P<0.01).③确立了空军飞行学员医学选拔体系评估指标,下设5个一级指标、13个二级指标和35个三级指标.一级指标(组织建设、制度建设、队伍建设、装备建设、业务建设)权重分别为0.162、0.172、0.400、0.184、0.082,最终指标权重通过一致性检验(CR<0.1). 结论 本研究构建的一套飞行学员医学选拔体系评估指标,可为我国空军飞行学员医学选拔体系的评估、建设提供理论依据与参考.%Objective To establish the evaluation and assessment system for the construction of medical selection system of Air Force flying cadets and to provide references for improving the theory of Air Force cadets selection system and the work efficiency of

  20. Challenges and Countermeasures for Cadets'Web- based College English Autonomous Learning Ability Cultivation%军校学员英语网络自主学习能力培养的挑战及对策

    Institute of Scientific and Technical Information of China (English)

    杨丽娟; 胡明霞

    2012-01-01

    College English Teaching in the new era has benefits more from multimedia and network technology, which brings about the new mode of combining traditional class teaching with web - based autonomous learning. In the process of establishing such a mode, cadets in military academies both show their distinct advantages and are also troubled with challenges due to the unique identity in the military school. The paper, from a survey of the author~ military academy, in a tentative attitude summarizes the challenges of effective web -based autonomous learning and then prescribes measures accordingly with the aim to promote cadets'web - based English autonomous learning ability and further develop the new teaching mode of College English Teaching in military academies.%摘要:新时期大学英语教学要依托多媒体网络技术手段,采用传统课堂与网络自主学习相结合的教学模式。在建设和推进这一教学模式的过程中,军校学员由于军队院校自身的特殊性,在开展网络自主学习时有其独特的优势,同时也面临着一定的挑战。分析军队院校有效开展网络自主学习面临的困难并提出相应对策,对提高军校学员英语网络自主学习能力、进一步完善军校大学英语教学模式提供参考意见。

  1. Sources of Bias in Outcome Assessment in Randomised Controlled Trials: A Case Study

    Science.gov (United States)

    Ainsworth, Hannah; Hewitt, Catherine E.; Higgins, Steve; Wiggins, Andy; Torgerson, David J.; Torgerson, Carole J.

    2015-01-01

    Randomised controlled trials (RCTs) can be at risk of bias. Using data from a RCT, we considered the impact of post-randomisation bias. We compared the trial primary outcome, which was administered blindly, with the secondary outcome, which was not administered blindly. From 44 schools, 522 children were randomised to receive a one-to-one maths…

  2. From randomised trials to rational practice.

    Science.gov (United States)

    van Gijn, J

    2005-01-01

    From the age of Enlightenment onwards, philosophical thinking has become increasingly influenced by empiricism: observations lead to theories, but experiments are needed to put the reasoning to the test. However, it was not until the middle of the 20th century that well-designed experiments were at last introduced in medical treatment, in the form of randomised controlled clinical trials. This design is now standard in medicine, but in everyday practice a multitude of management decisions must still be taken without good evidence. There are several reasons for this: there may not be a trial at all or only a single trial; trial results may be equivocal; patients may be different from those enrolled in trials; new procedures require practice, or a trial may not be feasible. 'Logical reasoning', with all its fallacies, is still required - not only to fill the gaps in empirical knowledge but also to interpret existing evidence and to plan new trials. In fact, the generation of new knowledge is a continuous, cyclical process in which newly gained insights in pathophysiology give rise to new therapeutic experiments, the results of which generate fresh hypotheses, and so on. Compassion, curiosity and doubt are the essential forces that keep the cycle moving. Conversely, the progress is slowed down by present-day legalism, which distorts investigator accountability and patient autonomy.

  3. A randomised comparison of cognitive behavioural therapy

    Directory of Open Access Journals (Sweden)

    Carlijn de Roos

    2011-04-01

    Full Text Available 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 : Children (n=52, aged 4–18 were randomly allocated to either CBT (n=26 or EMDR (n=26 in a disaster mental health after-care setting after an explosion of a fireworks factory. All children received up to four individual treatment sessions over a 4–8 week period along with up to four sessions of parent guidance. Blind assessment took place pre- and post-treatment and at 3 months follow-up on a variety of parent-rated and self-report measures of post-traumatic stress disorder symptomatology, depression, anxiety, and behaviour problems. Analyses of variance (general linear model repeated measures were conducted on the intention-to-treat sample and the completers. Results : Both treatment approaches produced significant reductions on all measures and results were maintained at follow-up. Treatment gains of EMDR were reached in fewer sessions. Conclusion : Standardised CBT and EMDR interventions can significantly improve functioning of disaster-exposed children.For the abstract in other languages, please see Supplementary files under Reading Tools online

  4. A randomised controlled trial of a probiotic 'functional food' in the management of irritable bowel syndrome.

    OpenAIRE

    Roberts, LM; McCahon, D; Holder, R; Wilson, S; Hobbs, FD

    2013-01-01

    BACKGROUND: Irritable Bowel Syndrome (IBS) is a common condition characterised by pain, distension and altered bowel habit. Evidence suggests functional foods containing probiotics improve gastrointestinal transit, however, data are limited by short follow-up periods and evaluation in selected populations. METHODS: A multi-centre, randomized, double blind, controlled trial to evaluate the effect of a probiotic vs non-probiotic dairy product on symptoms in IBS with a constipation element (IBS-...

  5. The ANKLE TRIAL (ANKLE treatment after injuries of the ankle ligaments: what is the benefit of external support devices in the functional treatment of acute ankle sprain? : a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Witjes Suzanne

    2012-02-01

    Full Text Available Abstract Background Acute lateral ankle ligament injuries are very common problems in present health care. Still there is no hard evidence about which treatment strategy is superior. Current evidence supports the view that a functional treatment strategy is preferable, but insufficient data are present to prove the benefit of external support devices in these types of treatment. The hypothesis of our study is that external ankle support devices will not result in better outcome in the treatment of acute ankle sprains, compared to a purely functional treatment strategy. Overall objective is to compare the results of three different strategies of functional treatment for acute ankle sprain, especially to determine the advantages of external support devices in addition to functional treatment strategy, based on balance and coordination exercises. Methods/design This study is designed as a randomised controlled multi-centre trial with one-year follow-up. Adult and healthy patients (N = 180 with acute, single sided and first inversion trauma of the lateral ankle ligaments will be included. They will all follow the same schedule of balancing exercises and will be divided into 3 treatment groups, 1. pressure bandage and tape, 2. pressure bandage and brace and 3. no external support. Primary outcome measure is the Karlsson scoring scale; secondary outcomes are FAOS (subscales, number of recurrent ankle injuries, Visual Analogue Scales of pain and satisfaction and adverse events. They will be measured after one week, 6 weeks, 6 months and 1 year. Discussion The ANKLE TRIAL is a randomized controlled trial in which a purely functional treated control group, without any external support is investigated. Results of this study could lead to other opinions about usefulness of external support devices in the treatment of acute ankle sprain. Trial registration Netherlands Trial Register (NTR: NTR2151

  6. Cadetes of the Academia do Polícia Militar do Estado do Rio de Janeiro Correlación entre VO2 max, gordura relativa y perfil lipídico, en cadetes de la Academia de Policía Militar del Estado de Río de Janeiro

    Directory of Open Access Journals (Sweden)

    E. H. M. Dantas

    2010-09-01

    Full Text Available The objective of the present study was to verify the correlation level among the max, the relative fat and the profile lipídico of 51 Cadets (Age = 23.63 3.58 years; Weight = 74.13 ± 10.46 kg; Height = 1.76 ± 0.06 m; IMC = 23.99 2.76 kg/m2, of the masculine gender, of the Academy of the Military police of the State of Rio de Janeiro, of the year of 2007. The subjects were active and participants of the military physical training (TFM accomplished five times a week, with duration of 60 minutes for session. They were appraised: the max for ergoespirometria (I record of progressive effort, with constant inclination of 3% and initial speed of 4,0km/h, the relative fat (% G - I record of three cutaneous folds and the profile lipídico, through the method Enzymatic Calorimétrico in the variables: total cholesterol (CT, triglicérides (TG, lipoproteína of density high-cholesterol (HDL-C and lipoproteína of density low-cholesterol (LDL-C. The test of correlation of Spearman presented correlation significant between max and TG (r = -0,289; p = 0,04,  max and HDL-C (r = 0,277; p = 0,049,% G and TG (r = 0,296; p = 0,035,% G and HDL-C (r = 0,338; p = 0,015. Like this, these discoveries point a discreet relationship between the profile lipídico and the maximum consumption of oxygen corroborating the need to consider other factors as the feeding and the intensity of the exercises in the investigation of this relationship.

    Key Words: training,  VO2 max, relative fat, lipidic profile.

     

    El objetivo del presente estudio es establecer el nivel de correlación entre el  VO2 max, la grasa relativa y el perfil lipídico de 51 cadetes varones (Edad = 23.63 ± 3.58 años; Peso = 74.13 ± 10.46 Kg.; Talla = 1.76  ± 0.06 m; IMC = 23.99 ± 2.76 Kg. /m2 de la Academia de la Policía Militar del Estado de Río de Janeiro, del año de 2007. Los sujetos son f

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

    Directory of Open Access Journals (Sweden)

    Jelsovsky Zhihong

    2010-05-01

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

  8. 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...

  9. 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...

  10. Yoga in schizophrenia : a systematic review of randomised controlled trials

    NARCIS (Netherlands)

    Vancampfort, D.; Vansteelandt, K.; Scheewe, T.; Probst, M.; Knapen, J.; De Herdt, A.; De Hert, M.

    2012-01-01

    Vancampfort D, Vansteelandt K, Scheewe T, Probst M, Knapen J, De Herdt A, De Hert M. Yoga in schizophrenia: a systematic review of randomised controlled trials. Objective: The objective of this systematic review was to assess the effectiveness of yoga as a complementary treatment on general psychopa

  11. Radiotherapy for Graves' orbitopathy : randomised placebo-controlled study

    NARCIS (Netherlands)

    Mourits, MP; van Kempen-Harteveld, ML; Garcia, MBG; Koppeschaar, HPF; Tick, L; Terwee, CB

    2000-01-01

    Background The best treatment (steroids, irradiation, or both) for moderately severe Graves' orbitopathy, a self-limiting disease is not known. We tested the efficacy of external beam irradiation compared with sham-irradiation. Methods In a double-blind randomised clinical trial, 30 patients with mo

  12. Immobilisation versus immediate mobilisation after intrauterine insemination: randomised controlled trial

    OpenAIRE

    Custers, Inge M; Flierman, Paul A; Maas, Pettie; Cox, Tessa; Van Dessel, Thierry J H M; Gerards, Mariette H; Mochtar, Monique H; Janssen, Catharina A H; van der Veen, Fulco; Ben Willem 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 insemination for unexplained, cervical factor, or male subfertility. Interventions 15 minutes of immobilisation or immediate mobilisation after insemination. Main outcome measure Ongoing pregnancy per couple...

  13. 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

    Directory of Open Access Journals (Sweden)

    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

  14. 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

  15. The use of spatial and randomisation-based methods for analysis of trials with treatments randomised into rows and columns

    DEFF Research Database (Denmark)

    Kristensen, Kristian

    2010-01-01

    The effect of restricted randomisations on the validity and efficiency of using spatial model as well as more common analysis of variance methods for analysing field trials was examined by simulating yields in agricultural fields with known spatial variation and analysing those using eight...

  16. 浅谈军校学员优良学风培育的心理激励策略%On the Psychological Incentive Strategy to Cultivate Good Style of Study of the Cadets

    Institute of Scientific and Technical Information of China (English)

    马金戈

    2012-01-01

    优良学是培养高素质新型军事人才的关键因素之一,心理激励的方法对于军校学员优良学风的培养有着重要的意义。运用心理激励的方法,就要坚持以人为本、目标导向、合理适度、因材施教等原则;在具体的心理激励策略方法上,可以采取目标激励、榜样激励、情感激励、竞争激励、奖惩激励等多种激励手段。%Good style of study one of the key factors in the training of qualified military personnel, and psychological in- centives for the cultivation of excellent academic atmosphere of the cadets of great significance. The use of psychological motivation, it is necessary to insist on people-oriented, goal-oriented, reasonable and appropriate, individualized principle of reciprocity; specific psychological motivational strategies can be taken to target incentives, role models inspire emotional in- centives, competition, incentive, reward and punishment for a variety of incentives means.

  17. Reported challenges in nurse-led randomised controlled trials

    DEFF Research Database (Denmark)

    Wang Vedelø, Tina; Lomborg, Kirsten

    2011-01-01

    ) nonadherence to research protocols and (iii) economic and organisational obstacles. These three challenges and barriers were inter-related and all were affected by time and timing. Conclusion: Randomised controlled trials are complex, expensive, time-consuming and highly demanding for researchers and the...... clinical nursing staff. Two lessons learned from this integrative review can be highlighted. First, we recommend researchers openly to share their experiences of barriers and challenges. They should describe factors that may have inhibited the desired outcome. Second, efforts to improve the collaboration...... between nurse researchers and clinicians, including education, training and support may increase the success rate and quality of nurse-led studies using the randomised controlled trial....

  18. Thermoregulatory effects of swaddling in Mongolia: a randomised controlled study

    OpenAIRE

    Tsogt, Bazarragchaa; Manaseki-Holland, Semira; Pollock, Jon; Blair, Peter S.; Fleming, Peter

    2015-01-01

    Objective To investigate thermal balance of infants in a Mongolian winter, and compare the effects of traditional swaddling with an infant sleeping-bag in apartments or traditional tents (Gers). Design A substudy within a randomised controlled trial. Setting Community in Ulaanbaatar, Mongolia. Subjects A stratified randomly selected sample of 40 swaddled and 40 non-swaddled infants recruited within 48 h of birth. Intervention Sleeping-bags and baby outfits of total thermal resistance equivale...

  19. Ear Acupressure for Smoking Cessation: A Randomised Controlled Trial

    OpenAIRE

    Zhang, Anthony L.; Yuan Ming Di; Christopher Worsnop; Brian H. May; Cliff Da Costa; Xue, Charlie C.L.

    2013-01-01

    This study investigated the efficacy and safety of ear acupressure (EAP) as a stand-alone intervention for smoking cessation and the feasibility of this study design. Adult smokers were randomised to receive EAP specific for smoking cessation (SSEAP) or a nonspecific EAP (NSEAP) intervention which is not typically used for smoking cessation. Participants received 8 weekly treatments and were requested to press the five pellets taped to one ear at least three times daily. Participants were fol...

  20. Randomised controlled trial of aminophylline for severe acute asthma

    OpenAIRE

    Yung, M; South, M

    1998-01-01

    OBJECTIVES—To determine whether children with severe acute asthma treated with large doses of inhaled salbutamol, inhaled ipratropium, and intravenous steroids are conferred any further benefits by the addition of aminophylline given intravenously.
STUDY DESIGN—Randomised, double blind, placebo controlled trial of 163 children admitted to hospital with asthma who were unresponsive to nebulised salbutamol.
RESULTS—The placebo and treatment groups of children were similar at b...

  1. 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

  2. Reduction of adverse effects from intravenous acetylcysteine treatment for paracetamol poisoning: a randomised controlled trial:a randomised controlled trial

    OpenAIRE

    Bateman, D Nicholas; Dear, James W; Thanacoody, H K Ruben; Thomas, Simon H L; Eddleston, Michael; Sandilands, Euan A; Coyle, Judy; Cooper, Jamie G.; Rodriguez, Aryelly; Butcher, Isabella; Lewis, Steff C.; Vliegenthart, A D Bastiaan; Veiraiah, Aravindan; Webb, David J.; Gray, Alasdair

    2014-01-01

    BACKGROUND: Paracetamol poisoning is common worldwide. It is treated with intravenous acetylcysteine, but the standard regimen is complex and associated with frequent adverse effects related to concentration, which can cause treatment interruption. We aimed to ascertain whether adverse effects could be reduced with either a shorter modified acetylcysteine schedule, antiemetic pretreatment, or both. METHODS: We undertook a double-blind, randomised factorial study at three UK hospitals, between...

  3. 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...

  4. Quality of life endovascular and open AAA repair. Results of a randomised trial.

    NARCIS (Netherlands)

    Prinssen, M.; Buskens, E.; Blankensteijn, J.D.

    2004-01-01

    AIM: To compare the quality of life (QoL) in the first postoperative year after elective endovascular abdominal aortic aneurysm repair (EVAR) and open repair (OR) in a randomised study. METHODS: In the Dutch Randomised Endovascular Aneurysm Management (DREAM) trial, patients are randomly allocated t

  5. A randomised controlled trial of a probiotic ‘functional food’ in the management of irritable bowel syndrome

    OpenAIRE

    Roberts, Lesley M; McCahon, Deborah; Holder, Roger; Wilson, Sue; Hobbs, FD Richard

    2013-01-01

    Background Irritable Bowel Syndrome (IBS) is a common condition characterised by pain, distension and altered bowel habit. Evidence suggests functional foods containing probiotics improve gastrointestinal transit, however, data are limited by short follow-up periods and evaluation in selected populations. Methods A multi-centre, randomized, double blind, controlled trial to evaluate the effect of a probiotic vs non-probiotic dairy product on symptoms in IBS with a constipation element (IBS – ...

  6. 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...

  7. 中美空军飞行学员医学选拔对照实证研究--远视力%An empirical study on medical selection of lfying cadets with distant vision between PLAAF and USAF

    Institute of Scientific and Technical Information of China (English)

    齐林嵩; 邹志康; 田青; 姜彩辉; 杨庆红; 张湘; 吴腾云; 黄美良; 马中立

    2016-01-01

    目的:筛查我军定选因远视力原因淘汰学员按美军标准的评估情况,并对中美两军的医学选拔标准进行合理探讨,提出我军标准修改建议。方法统计我军2013—2015年招飞体检定选学员远视力不合格情况,并参考美军招飞医学标准,对不合格人数拟重新纳入选拔并对结果进行统计分析。结果近3年招飞体检学员因远视力不合格的构成比在2014年达45.8%,而在2015年降到34.0%,各年比重差异有统计学意义(χ2=23.98,P<0.05)。参考美军医学标准,远视力不合格淘汰的学员,保留比例在92.7%左右。结论美军招飞医学选拔标准在远视力方面较我军宽泛,并在屈光手术方面有详细的描述。建议我军仍需严把远视力质量关,若逐渐将成熟的角膜屈光手术技术加入标准后,可适当放宽标准。%ObjectiveTo screen the virtual qualified rate of our disqualified students by the US Medical Standards Directory on distant vision and to discuss the similarities and differences of Medical Standards Directory between PLAAF and USAF.MethodsBy surveying the unqualified rates of distant vision, and the qualified rates of our unqualified cadets referring to the US Medical Standards Directory from 2013 to 2015, results were statistically analyzed. ResultsFrom 2013 to 2015, the unqualified constituent ratio of distant vision was 45.8% in 2014, which declined to 34.0% in 2015, and there was significant difference in statistics among each year (χ2=23.98,P<0.05). Upon referring to the US Medical Standards Directory, the myopia had a higher retention ratio of nearly 92.7%. There was only one retained of our unqualified cadets on hyperopia.ConclusionThe US Medical Standards Directory is broad, specific, reasonable, and has a detailed description of refractive surgery. We suggest that we still should take a strict quality control on distant vision, and if we have put mature corneal refractive

  8. The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions

    OpenAIRE

    Downs, S. H.; Black, N.

    1998-01-01

    OBJECTIVE: To test the feasibility of creating a valid and reliable checklist with the following features: appropriate for assessing both randomised and non-randomised studies; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting, internal validity (bias and confounding) and power, but also for external validity. DESIGN: A pilot version was first developed, based on epidemiological principles, reviews, and existing checklists...

  9. Novel Three-Day, Community-Based, Nonpharmacological Group Intervention for Chronic Musculoskeletal Pain (COPERS): A Randomised Clinical Trial

    Science.gov (United States)

    Taylor, Stephanie J. C.; Carnes, Dawn; Homer, Kate; Kahan, Brennan C.; Hounsome, Natalia; Eldridge, Sandra; Spencer, Anne; Pincus, Tamar; Underwood, Martin

    2016-01-01

    Background Chronic musculoskeletal pain is the leading cause of disability worldwide. The effectiveness of pharmacological treatments for chronic pain is often limited, and there is growing concern about the adverse effects of these treatments, including opioid dependence. Nonpharmacological approaches to chronic pain may be an attractive alternative or adjunctive treatment. We describe the effectiveness of a novel, theoretically based group pain management support intervention for chronic musculoskeletal pain. Methods and Findings We conducted a multi-centre, pragmatic, randomised, controlled effectiveness and cost-effectiveness (cost–utility) trial across 27 general practices and community musculoskeletal services in the UK. We recruited 703 adults with musculoskeletal pain of at least 3 mo duration between August 1, 2011, and July 31, 2012, and randomised participants 1.33:1 to intervention (403) or control (300). Intervention participants were offered a participative group intervention (COPERS) delivered over three alternate days with a follow-up session at 2 wk. The intervention introduced cognitive behavioural approaches and was designed to promote self-efficacy to manage chronic pain. Controls received usual care and a relaxation CD. The primary outcome was pain-related disability at 12 mo (Chronic Pain Grade [CPG] disability subscale); secondary outcomes included the CPG disability subscale at 6 mo and the following measured at 6 and 12 mo: anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), pain acceptance (Chronic Pain Acceptance Questionnaire), social integration (Health Education Impact Questionnaire social integration and support subscale), pain-related self-efficacy (Pain Self-Efficacy Questionnaire), pain intensity (CPG pain intensity subscale), the census global health question (2011 census for England and Wales), health utility (EQ-5D-3L), and health care resource use. Analyses followed the intention-to-treat principle

  10. Electronic voting to encourage interactive lectures: a randomised trial

    Directory of Open Access Journals (Sweden)

    Palmer Edward

    2007-07-01

    Full Text Available Abstract Background Electronic Voting Systems have been used for education in a variety of disciplines. Outcomes from these studies have been mixed. Because results from these studies have been mixed, we examined whether an EVS system could enhance a lecture's effect on educational outcomes. Methods A cohort of 127 Year 5 medical students at the University of Adelaide was stratified by gender, residency status and academic record then randomised into 2 groups of 64 and 63 students. Each group received consecutive 40-minute lectures on two clinical topics. One group received the EVS for both topics. The other group received traditional teaching only. Evaluation was undertaken with two, 15-question multiple-choice questionnaires (MCQ assessing knowledge and problem solving and undertaken as a written paper immediately before and after the lectures and repeated online 8–12 weeks later. Standardised institutional student questionnaires were completed for each lecture and independent observers assessed student behaviour during the lectures. Lecturer's opinions were assessed by a questionnaire developed for this study. Results Two-thirds of students randomised to EVS and 59% of students randomised to traditional lectures attended. One-half of the students in the EVS group and 41% in the traditional group completed all questionnaires. There was no difference in MCQ scores between EVS and traditional lectures (p = 0.785. The cervical cancer lectures showed higher student ranking in favour of EVS in all parameters. The breast cancer lectures showed higher ranking in favour of traditional lectures in 5 of 7 parameters (p Conclusion In this setting, EVS technology used in large group lectures did not offer significant advantages over the more traditional lecture format.

  11. Randomised clinical trials with clinician-preferred treatment.

    Science.gov (United States)

    Korn, E L; Baumrind, S

    1991-01-19

    The standard design for randomised clinical trials may be inappropriate when the clinician believes that one of the treatments being tested is superior for the patient, or when the clinician has a preference for one of the treatments. For such instances the suggestion is that the patient is randomly allocated to treatment only when there is clinical disagreement about treatment of choice for that patient, and then the patient is assigned to a clinician who had thought that the regimen allocated is the one most appropriate for that patient.

  12. Mendelian Randomisation Study of Childhood BMI and Early Menarche

    OpenAIRE

    Hannah S. Mumby; Elks, Cathy E; Shengxu Li; Sharp, Stephen J.; Kay-Tee Khaw; Luben, Robert N; Wareham, Nicholas J; Loos, Ruth J. F.; Ken K Ong

    2011-01-01

    To infer the causal association between childhood BMI and age at menarche, we performed a mendelian randomisation analysis using twelve established “BMI-increasing” genetic variants as an instrumental variable (IV) for higher BMI. In 8,156 women of European descent from the EPIC-Norfolk cohort, height was measured at age 39–77 years; age at menarche was self-recalled, as was body weight at age 20 years, and BMI at 20 was calculated as a proxy for childhood BMI. DNA was genotyped for twelve BM...

  13. Bach flower remedies: a systematic review of randomised clinical trials.

    Science.gov (United States)

    Ernst, Edzard

    2010-01-01

    Bach flower remedies continue to be popular and its proponents make a range of medicinal claims for them. The aim of this systematic review was to critically evaluate the evidence for these claims. Five electronic databases were searched without restrictions on time or language. All randomised clinical trials of flower remedies were included. Seven such studies were located. All but one were placebo-controlled. All placebo-controlled trials failed to demonstrate efficacy. It is concluded that the most reliable clinical trials do not show any differences between flower remedies and placebos. PMID:20734279

  14. An empirical study on medical selection of flying cadets with contracture and maldevelopment of the iliotibial band between PLAAF and USAF%中美空军飞行学员医学选拔对照实证研究——髂胫束发育不良与挛缩

    Institute of Scientific and Technical Information of China (English)

    厉晓杰; 邹志康; 杜俊杰; 朱克顺; 袁超凡; 夏青; 吉保民; 马中立

    2016-01-01

    Objective To find out the differences between the standards of contracture and maldevelopment of the iliotibial band in PLA air force flying cadets recruiting medical standard directory and United States air force medical standard directory, and to provide a method for the reform of PLA air force flying cadets recruiting medical standard directory.Method The reject rate and comprehensive assessment qualified rate of contracture and maldevelopment of the iliotibial band in flying cadet recruiting final selective physical examination was from 2012 to 2015. by comparing the standards of contracture and maldevelopment of the iliotibial band in PLA air force flying cadets recruiting medical standard directory and in the United States air force medical standard directory, and empirical study was carried out. Results In flying cadet recruiting final selective physical examination from 2012 to 2015, only 28 candidates were eliminated because of contracture and maldevelopment of the iliotibial band, accounting for 14.2% of the eliminated candidates because of orthopeadics diseases. 5 candidates with contracture and maldevelopment of the iliotibial band were admitted by comprehensive assessment in 2014 and 7 in 2015 by comprehensive assessment, which accounted for 5.1% in candidates with orthopeadics diseases. The standards of contracture and maldevelopment of the iliotibial band in PLA air force flying cadets recruiting medical standard directory were unsatisfactory in accuracy and scientificity. Because those standards of USAF were based on function of lower extremities, and dismissed the diseases and signs related to contracture and maldevelopment of the iliotibial band. Based on US air force medical standard directory, among candidates rejected because of contracture and maldevelopment of the iliotibial band, all the unqualified candidates for PLAAF standardswere qualified for USAF standards. Among candidates with contracture and maldevelopment of the iliotibial band

  15. Researching Effective Strategies to Improve Insulin Sensitivity in Children and Teenagers - RESIST. A randomised control trial investigating the effects of two different diets on insulin sensitivity in young people with insulin resistance and/or pre-diabetes.

    Directory of Open Access Journals (Sweden)

    De Sukanya

    2010-09-01

    Full Text Available Abstract Background Concomitant with the rise in childhood obesity there has been a significant increase in the number of adolescents with clinical features of insulin resistance and prediabetes. Clinical insulin resistance and prediabetes are likely to progress to type 2 diabetes and early atherosclerosis if not targeted for early intervention. There are no efficacy trials of lifestyle intervention in this group to inform clinical practice. The primary aim of this randomised control trial (RCT is to determine the efficacy and effectiveness of two different structured lifestyle interventions differing in diet composition on insulin sensitivity, in adolescents with clinical insulin resistance and/or prediabetes treated with metformin. Methods/design This study protocol describes the design of an ongoing RCT. We are recruiting 108 (54 each treatment arm 10 to 17 year olds with clinical features of insulin resistance and/or prediabetes, through physician referral, into a multi-centred RCT. All participants are prescribed metformin and participate in a diet and exercise program. The lifestyle program is the same for all participants except for diet composition. The diets are a high carbohydrate, low fat diet and a moderate carbohydrate, increased protein diet. The program commences with an intensive 3 month dietary intervention, implemented by trained dietitians, followed by a 3 month intensive gym and home based exercise program, supervised by certified physical trainers. To measure the longer term effectiveness, after the intensive intervention trial participants are managed by either their usual physician or study physician and followed up by the study dietitians for an additional 6 months. The primary outcome measure, change in insulin sensitivity, is measured at 3, 6 and 12 months. Discussion Clinical insulin resistance and prediabetes in the paediatric population are rapidly emerging clinical problems with serious health outcomes. With

  16. Une socialisation professionnelle par l’histoire : la formation morale des Saint-Cyriens et le martyrologe patriotique Being professionally socialized by History : the moral training of Saint-Cyr cadets and the legend of patriotic martyrs

    Directory of Open Access Journals (Sweden)

    Alex Alber

    2009-07-01

    Full Text Available À travers l’étude de l’École Spéciale Militaire de Saint-Cyr Coëtquidan, l’article montre comment la formation des officiers français de recrutement direct repose sur une préparation pensée comme tripartite : militaire, académique et « morale ». Cette dernière dimension suppose notamment la transmission d’une mémoire collective, qui peut être étudiée comme un facteur de socialisation professionnelle. Non sans évoquer les limites d’un tel mécanisme, l’article entend montrer comment la magnification et la remémoration constante des hauts faits de l’histoire militaire, et tout particulièrement des sacrifices pro patria, peuvent servir à fortifier le patriotisme des élèves-officiers. En utilisant les résultats d’une enquête quantitative menée de manière synchronique auprès des élèves de l’ESM à leur entrée et à leur sortie de l’école, on aboutit toutefois au constat que l’école concourt à fortifier ces valeurs plus qu’elle ne les produit, et que le temps aidant, l’exaltation initiale des élèves pour les éléments absolus de l’engagement se nuance d’une connaissance plus empirique des réalités du métier.Using data gathered while researching the Special Military Academy (École Spéciale militaire of Saint-Cyr Coëtquidan in 2002, this article shows that the training of future French officers can be subdivided into three different sorts of instruction : military, academic and “moral”. The interest of the latter is that it seems to take advantage of the transmission of the memory of former officers having laid down their lives for France as a means to reinforce the cadets’ patriotism. The article points to the fact that cadets are often already convinced of the importance of patriotism and other military values upon entering the military academy. Moreover, with the passage of time, the cadets’ enthusiasm for bravery and sacrifice seems to cool slightly, as they slowly

  17. 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

  18. Deprescribing in Frail Older People: A Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Kathleen Potter

    Full Text Available Deprescribing has been proposed as a way to reduce polypharmacy in frail older people. We aimed to reduce the number of medicines consumed by people living in residential aged care facilities (RACF. Secondary objectives were to explore the effect of deprescribing on survival, falls, fractures, hospital admissions, cognitive, physical, and bowel function, quality of life, and sleep.Ninety-five people aged over 65 years living in four RACF in rural mid-west Western Australia were randomised in an open study. The intervention group (n = 47 received a deprescribing intervention, the planned cessation of non-beneficial medicines. The control group (n = 48 received usual care. Participants were monitored for twelve months from randomisation. Primary outcome was change in the mean number of unique regular medicines. All outcomes were assessed at baseline, six, and twelve months.Study participants had a mean age of 84.3 ± 6.9 years and 52% were female. Intervention group participants consumed 9.6 ± 5.0 and control group participants consumed 9.5 ± 3.6 unique regular medicines at baseline. Of the 348 medicines targeted for deprescribing (7.4 ± 3.8 per person, 78% of regular medicines, 207 medicines (4.4 ± 3.4 per person, 59% of targeted medicines were successfully discontinued. The mean change in number of regular medicines at 12 months was -1.9 ± 4.1 in intervention group participants and +0.1 ± 3.5 in control group participants (estimated difference 2.0 ± 0.9, 95%CI 0.08, 3.8, p = 0.04. Twelve intervention participants and 19 control participants died within 12 months of randomisation (26% versus 40% mortality, p = 0.16, HR 0.60, 95%CI 0.30 to 1.22 There were no significant differences between groups in other secondary outcomes. The main limitations of this study were the open design and small participant numbers.Deprescribing reduced the number of regular medicines consumed by frail older people living in residential care with no significant

  19. Electronic voting to encourage interactive lectures: a randomised trial

    Science.gov (United States)

    2007-01-01

    Background Electronic Voting Systems have been used for education in a variety of disciplines. Outcomes from these studies have been mixed. Because results from these studies have been mixed, we examined whether an EVS system could enhance a lecture's effect on educational outcomes. Methods A cohort of 127 Year 5 medical students at the University of Adelaide was stratified by gender, residency status and academic record then randomised into 2 groups of 64 and 63 students. Each group received consecutive 40-minute lectures on two clinical topics. One group received the EVS for both topics. The other group received traditional teaching only. Evaluation was undertaken with two, 15-question multiple-choice questionnaires (MCQ) assessing knowledge and problem solving and undertaken as a written paper immediately before and after the lectures and repeated online 8–12 weeks later. Standardised institutional student questionnaires were completed for each lecture and independent observers assessed student behaviour during the lectures. Lecturer's opinions were assessed by a questionnaire developed for this study. Results Two-thirds of students randomised to EVS and 59% of students randomised to traditional lectures attended. One-half of the students in the EVS group and 41% in the traditional group completed all questionnaires. There was no difference in MCQ scores between EVS and traditional lectures (p = 0.785). The cervical cancer lectures showed higher student ranking in favour of EVS in all parameters. The breast cancer lectures showed higher ranking in favour of traditional lectures in 5 of 7 parameters (p lecturer-students interactions were increased in the EVS lecture for one lecturer and reduced for the other. Both lecturers felt that the EVS lectures were difficult to prepare, that they were able to keep to time in the traditional lectures, that the educational value of both lecture styles was similar, and that they were neutral-to-slightly favourably disposed

  20. A randomised trial of lung sealant versus medical therapy for advanced emphysema

    OpenAIRE

    Come, Carolyn E.; Kramer, Mordechai R.; Dransfield, Mark T.; Abu-Hijleh, Muhanned; Berkowitz, David; Bezzi, Michela; Bhatt, Surya P; Boyd, Michael B.; Cases, Enrique; Chen, Alexander C.; Christopher B. Cooper; Flandes, Javier; Gildea, Thomas; Gotfried, Mark; Hogarth, D. Kyle

    2015-01-01

    Uncontrolled pilot studies demonstrated promising results of endoscopic lung volume reduction using emphysematous lung sealant (ELS) in patients with advanced, upper lobe predominant emphysema. We aimed to evaluate the safety and efficacy of ELS in a randomised controlled setting.

  1. Practical aspects of conducting a pragmatic randomised trial in primary care: patient recruitment and outcome assessment

    NARCIS (Netherlands)

    D.A.W.M. van der Windt (Daniëlle); B.W. Koes (Bart); M. van Aarst; M.A. Heemskerk; L.M. Bouter (Lex)

    2000-01-01

    textabstractBACKGROUND: Conducting a pragmatic randomised trial in primary care is often accompanied by practical problems. Such problems are seldom reported and may constitute useful lessons for researchers planning future trials. AIM: To address the difficulties invol

  2. Supervised exercise therapy versus usual care for patellofemoral pain syndrome : an open label randomised controlled trial

    NARCIS (Netherlands)

    van Linschoten, R.; van Middelkoop, M.; Berger, M. Y.; Heintjes, E. M.; Verhaar, J. A. N.; Willemsen, S. P.; Koes, B. W.; Bierma-Zeinstra, S. M.

    2009-01-01

    Objective To assess the effectiveness of supervised exercise therapy compared with usual care with respect to recovery, pain, and function in patients with patellofemoral pain syndrome. Design Open label randomised controlled trial. Setting General practice and sport physician practice. Participants

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

    OpenAIRE

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

    2016-01-01

    Objectives We sought evidence of effectiveness of lay support to improve maternal and child outcomes in disadvantaged families. Design Prospective, pragmatic, individually randomised controlled trial. Setting 3 Maternity Trusts in West Midlands, UK. Participants Following routine midwife systematic assessment of social risk factors, 1324 nulliparous women were assigned, using telephone randomisation, to standard maternity care, or addition of referral to a Pregnancy Outreach Worker (POW) serv...

  4. A randomised controlled trial of azithromycin therapy in bronchiolitis obliterans syndrome (BOS) post lung transplantation

    OpenAIRE

    Corris, Paul A; Ryan, Victoria A; Small, Therese; Lordan, James; Fisher, Andrew J.; Meachery, Gerard; Johnson, Gail; Ward, Chris

    2015-01-01

    Background We conducted a placebo-controlled trial of azithromycin therapy in bronchiolitis obliterans syndrome (BOS) post lung transplantation. Methods We compared azithromycin (250 mg alternate days, 12 weeks) with placebo. Primary outcome was FEV1 change at 12 weeks. Results 48 patients were randomised; (25 azithromycin, 23 placebo). It was established, post randomisation that two did not have BOS. 46 patients were analysed as intention to treat (ITT) with 33 ‘Completers’. ITT analysis inc...

  5. Randomised comparison of silicone versus Teflon cannulas for peripheral intravenous nutrition.

    OpenAIRE

    Reynolds, J V; Walsh, K; Ruigrok, J; Hyland, J M

    1995-01-01

    The use of peripheral intravenous nutrition using standard Teflon cannulas is limited by a high incidence of thrombophlebitis, with resultant frequent line changes and compromised nutritional therapy. Fine-bore silicone catheters may reduce the incidence of thrombophlebitis; we prospectively compared the silicone catheter with a Teflon cannula in a randomised trial. Seventy-nine surgical patients were randomised to receive peripheral nutrition (10 g nitrogen; 1770 kcal; 650 mOsm/l) either via...

  6. A 2-year randomised placebo-controlled trial of doxycycline for lymphangioleiomyomatosis

    OpenAIRE

    Chang, William Y.C.; Cane, Jennifer L; Kumaran, Maruti; Lewis, Sarah; Tattersfield, Anne E.; Johnson, Simon R

    2014-01-01

    Lymphangioleiomyomatosis (LAM) is characterised by lung cysts and airflow obstruction. Matrix metalloproteinases have been implicated in lung destruction in LAM. We performed a randomised, double-blind trial, comparing the matrix metalloproteinases inhibitor doxycycline with placebo on the progression of LAM. 23 females with LAM were randomised to doxycycline 100 mg daily for 3 months followed by 200 mg daily for 21 months, or matched placebo. Lung function, exercise capacity, quality of...

  7. 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...

  8. Homoeopathy for delayed onset muscle soreness: a randomised double blind placebo controlled trial.

    OpenAIRE

    Vickers, A J; Fisher, P.; Smith, C.; Wyllie, S E; Lewith, G T

    1997-01-01

    OBJECTIVE: To pilot a model for determining whether a homoeopathic medicine is superior to placebo for delayed onset muscle soreness (DOMS). DESIGN: Randomised double blind placebo controlled trial. SETTING: Physiotherapy department of a homoeopathic hospital. SUBJECTS: Sixty eight healthy volunteers (average age 30; 41% men) undertook a 10 minute period of bench stepping carrying a small weight and were randomised to a homoeopathic medicine or placebo. OUTCOME MEASURES: Mean muscle soreness ...

  9. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

    OpenAIRE

    O’Cathain, A.; Hoddinott, P.; Lewin, S; Thomas, K J; Young, B; Adamson, J.; Jansen, J.F.M.; Mills, N; Moore, G.; Donovan, J.L.

    2015-01-01

    Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full trial. We present guidance that researchers, research funders and reviewers may wish to consider when assessing or undertaking qualitative research within feasibility studies for randomised controll...

  10. The gastrointestinal toxicity of aspirin: an overview of randomised controlled trials.

    OpenAIRE

    Roderick, P. J.; Wilkes, H C; Meade, T W

    1993-01-01

    The proven benefit of aspirin in the secondary prevention of cardiovascular disease and its possible value in primary prevention must be weighted against its potential hazards. This paper is an overview of the gastrointestinal toxicity of aspirin, its most serious complication after intracerebral haemorrhage. Information on toxicity has been drawn only from randomised trials, thus avoiding the potential biases of observational studies. All randomised placebo controlled trials listed in the An...

  11. Careful science? Bodywork and care practices in randomised clinical trials

    DEFF Research Database (Denmark)

    Jespersen, Astrid Pernille; Bønnelycke, Julie; Eriksen, Hanne Hellerup

    2013-01-01

    Concern about obesity has prompted numerous public health campaigns that urge people to be more physically active. The campaigns often include normative statements and attempt to impose restrictions on individuals' lives without considering the complexities of daily life. We suggest that broadening...... the focus to reflect everyday practices would foster better targeted public health campaigns. This article is based on our participation in FINE, a multidisciplinary Danish research project. The core methodology of FINE was a randomised controlled trial in which 61 moderately overweight men were put...... into different exercise groups. In this article we analyse the scientific work of the trial as representing entangled processes of bodywork, where data are extracted and objectified bodies are manipulated and care practices address the emotional, social and mundane aspects of the participants' everyday lives...

  12. Choosing a control intervention for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Djulbegovic Benjamin

    2003-04-01

    Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.

  13. Bronchodilators for treatment of mild bronchiolitis: a factorial randomised trial.

    Science.gov (United States)

    Wang, E E; Milner, R; Allen, U; Maj, H

    1992-01-01

    A randomised double blind trial was conducted to determine the efficacy of inhaled bronchodilators, salbutamol and ipratropium bromide, compared with placebo in the treatment of bronchiolitis. Patients, who were 2 months to 2 years of age and without underlying cardiac or pulmonary disease, received drug 1 (salbutamol or saline placebo) followed one hour later by drug 2 (ipratropium bromide or placebo). Both agents were administered every four hours. The patients were allocated to one of four groups according to a factorial design. The four groups were similar in demographic characteristics, initial oxygenation, and clinical score. The change in oxygen saturation of recipients of both agents was significantly better than that of recipients of salbutamol alone or ipratropium bromide alone. This change, however, was not statistically different from that of the control group. No difference was observed in the clinical score or hospital duration. Inhaled bronchodilators did not improve the condition of hospitalised mild bronchiolitis. PMID:1533504

  14. Statistical issues in randomised controlled trials: a narrative synthesis

    Institute of Scientific and Technical Information of China (English)

    Bolaji; Emmanuel; Egbewale

    2015-01-01

    Randomised controlled trials(RCTs) are gold standard in the evaluation of treatment efficacy in medical investigations, only if well designed and implemented. Till date, distorted views and misapplications of statistical procedures involved in RCTs are still in practice. Hence, clarification of concepts and acceptable practices related to certain statistical issues involved in the design, conduct and reporting of randomised controlled trials is needed. This narrative synthesis aimed at providing succinct but clear information on the concepts and practices of selected statistical issues in RCTs to inform correct applications. The use of tests of significance is no longer acceptable as means to compare baseline similarity between treatment groups and in determining which covariate(s) should be included in the model for adjustment. Distribution of baseline attributes simply presented in tabular form is however, rather preferred. Regarding covariate selection, such approach that makes use of information on the degree of correlation between the covariate(s) and the outcome variable is more in tandem with statistical principle(s) than that based on tests of significance. Stratification and minimisation are not alternatives to covariate adjusted analysis; in fact they establish the need for one. Intention-totreat is the preferred approach for the evaluation of primary outcome measures and researchers have responsibility to report whether or not the procedure was followed. A major use of results from subgroup analysis is to generate hypothesis for future clinical trials. Since RCTs are gold standard in the comparison of medical interventions, researchers cannot afford the practices of distorted allocation or statistical procedures in this all important experimental design method.

  15. Can a self-management programme delivered by a community pharmacist improve asthma control? A randomised trial

    OpenAIRE

    Barbanel, D; Eldridge, S; Griffiths, C

    2003-01-01

    Background: No randomised studies have addressed whether self-management for asthma can be successfully delivered by community pharmacists. Most randomised trials of asthma self-management have recruited participants from secondary care; there is uncertainty regarding its effectiveness in primary care. A randomised controlled study was undertaken to determine whether a community pharmacist could improve asthma control using self-management advice for individuals recruited during attendance at...

  16. Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform.

    Science.gov (United States)

    Treweek, Shaun; Altman, Doug G; Bower, Peter; Campbell, Marion; Chalmers, Iain; Cotton, Seonaidh; Craig, Peter; Crosby, David; Davidson, Peter; Devane, Declan; Duley, Lelia; Dunn, Janet; Elbourne, Diana; Farrell, Barbara; Gamble, Carrol; Gillies, Katie; Hood, Kerry; Lang, Trudie; Littleford, Roberta; Loudon, Kirsty; McDonald, Alison; McPherson, Gladys; Nelson, Annmarie; Norrie, John; Ramsay, Craig; Sandercock, Peter; Shanahan, Daniel R; Summerskill, William; Sydes, Matt; Williamson, Paula; Clarke, Mike

    2015-06-05

    Randomised trials are at the heart of evidence-based healthcare, but the methods and infrastructure for conducting these sometimes complex studies are largely evidence free. Trial Forge ( www.trialforge.org ) is an initiative that aims to increase the evidence base for trial decision making and, in doing so, to improve trial efficiency.This paper summarises a one-day workshop held in Edinburgh on 10 July 2014 to discuss Trial Forge and how to advance this initiative. We first outline the problem of inefficiency in randomised trials and go on to describe Trial Forge. We present participants' views on the processes in the life of a randomised trial that should be covered by Trial Forge.General support existed at the workshop for the Trial Forge approach to increase the evidence base for making randomised trial decisions and for improving trial efficiency. Agreed upon key processes included choosing the right research question; logistical planning for delivery, training of staff, recruitment, and retention; data management and dissemination; and close down. The process of linking to existing initiatives where possible was considered crucial. Trial Forge will not be a guideline or a checklist but a 'go to' website for research on randomised trials methods, with a linked programme of applied methodology research, coupled to an effective evidence-dissemination process. Moreover, it will support an informal network of interested trialists who meet virtually (online) and occasionally in person to build capacity and knowledge in the design and conduct of efficient randomised trials.Some of the resources invested in randomised trials are wasted because of limited evidence upon which to base many aspects of design, conduct, analysis, and reporting of clinical trials. Trial Forge will help to address this lack of evidence.

  17. Enlightenment to Chinese Air Force of USAF medical selection standard system of flying cadets%美国空军飞行学员医学选拔标准体系及其对我军的启示

    Institute of Scientific and Technical Information of China (English)

    邹志康; 张凌; 王广云; 孙金杰; 夏青; 刘伟; 吉保民; 马中立

    2016-01-01

    . The four documents independently aim directly at different examination contents, and the medical requirements has been gradually broadened. The Examination and Standards originates from the requirements of military training flying demands. Compared with our standards, the American medical standards are more consummate, and more subtle, and emphasize on more body functions than body shape. The periodicity of standards revising was shorter than ours. We can establish our standards and requirements of flying pilots and rectify our medical standards by referring to the American standards, efficacious and safe medical standards can effectively improve the diathesis of our military cadets.

  18. Randomised controlled trial of the effect of long-term selenium supplementation on plasma cholesterol in an elderly Danish population

    DEFF Research Database (Denmark)

    Cold, Frederik; Winther, Kristian H; Pastor-Barriuso, Roberto;

    2015-01-01

    PRECISE (PREvention of Cancer by Intervention with Selenium) pilot study (ClinicalTrials.gov ID: NCT01819649) was a 5-year randomised, double-blinded, placebo-controlled trial with four groups (allocation ratio 1:1:1:1). Men and women aged 60-74 years (n 491) were randomised to 100 (n 124), 200 (n 122) or...

  19. Autotitrating versus standard noninvasive ventilation: a randomised crossover trial.

    Science.gov (United States)

    Jaye, J; Chatwin, M; Dayer, M; Morrell, M J; Simonds, A K

    2009-03-01

    The aim of the present study was to compare the efficacy of automatic titration of noninvasive ventilation (NIV) with conventional NIV in stable neuromuscular and chest wall disorder patients established on long-term ventilatory support. In total, 20 neuromuscular and chest wall disease patients with nocturnal hypoventilation treated with long-term NIV completed a randomised crossover trial comparing two noninvasive pressure support ventilators: a standard bilevel ventilator (VPAP III) and a novel autotitrating bilevel ventilator (AutoVPAP). Baseline physiological measurements, overnight polysomnography and Holter monitoring were repeated at the end of each 1-month treatment period. Nocturnal oxygenation was comparable between the autotitrating device and standard ventilator, as were sleep efficiency, arousals and heart rate variability. However, there was a small significant increase in mean overnight transcutaneous carbon dioxide tension (median (interquartile range) 7.2 (6.7-7.7) versus 6.7 (6.1-7.0) kPa) and a decrease in percentage stage 1 sleep (mean+/-sd 16+/-9 versus 19+/-10%) on autotitrating NIV compared with conventional NIV. Autotitrating noninvasive ventilation using AutoVPAP produced comparable control of nocturnal oxygenation to standard nonivasive ventilation, without compromising sleep quality in stable neuromuscular and chest wall disease patients requiring long-term ventilatory support for nocturnal hypoventilation. PMID:19251798

  20. Should desperate volunteers be included in randomised controlled trials?

    Science.gov (United States)

    Allmark, P; Mason, S

    2006-09-01

    Randomised controlled trials (RCTs) sometimes recruit participants who are desperate to receive the experimental treatment. This paper defends the practice against three arguments that suggest it is unethical first, desperate volunteers are not in equipoise. Second clinicians, entering patients onto trials are disavowing their therapeutic obligation to deliver the best treatment; they are following trial protocols rather than delivering individualised care. Research is not treatment; its ethical justification is different. Consent is crucial. Third, desperate volunteers do not give proper consent: effectively, they are coerced. This paper responds by advocating a notion of equipoise based on expert knowledge and widely shared values. Where such collective, expert equipoise exists there is a prima facie case for an RCT. Next the paper argues that trial entry does not involve clinicians disavowing their therapeutic obligation; individualised care based on insufficient evidence is not in patients best interest. Finally, it argues that where equipoise exists it is acceptable to limit access to experimental agents; desperate volunteers are not coerced because their desperation does not translate into a right to receive what they desire.

  1. Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid)--a double-blind, randomised, multicentre study in adults

    DEFF Research Database (Denmark)

    Klek, Stanislaw; Chambrier, Cecile; Singer, Pierre;

    2013-01-01

    The aim of this study was to evaluate the safety and tolerance of a soybean/MCT/olive/fish oil emulsion in intestinal failure patients on long-term parenteral nutrition. 73 patients took part in a randomized, double-blind, multi-centre study. The study demonstrates that the lipid emulsion...... containing four different types of oils is safe and well tolerated in long-term PN....

  2. 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...

  3. Infant feeding bottle design, growth and behaviour: results from a randomised trial

    Directory of Open Access Journals (Sweden)

    Fewtrell MS

    2012-03-01

    Full Text Available Abstract Background Whether the design of an anti-vacuum infant feeding bottle influences infant milk intake, growth or behavior is unknown, and was the subject of this randomized trial. Methods Subjects 63 (36 male healthy, exclusively formula-fed term infants. Intervention Randomisation to use Bottle A (n = 31, one-way air valve: Philips Avent versus Bottle B (n = 32, internal venting system: Dr Browns. 74 breast-fed reference infants were recruited, with randomisation (n = 24 to bottle A (n = 11 or B (n = 13 if bottle-feeding was subsequently introduced. Randomisation stratified by gender and parity; computer-based telephone randomisation by independent clinical trials unit. Setting Infant home. Primary outcome measure infant weight gain to 4 weeks. Secondary outcomes (i milk intake (ii infant behaviour measured at 2 weeks (validated 3-day diary; (iii risk of infection; (iv continuation of breastfeeding following introduction of mixed feeding. Results Number analysed for primary outcome Bottle A n = 29, Bottle B n = 25. Primary outcome There was no significant difference in weight gain between randomised groups (0-4 weeks Bottle A 0.74 (SD 1.2 SDS versus bottle B 0.51 (0.39, mean difference 0.23 (95% CI -0.31 to 0.77. Secondary outcomes Infants using bottle A had significantly less reported fussing (mean 46 versus 74 minutes/day, p Breast-fed reference group There were no significant differences in primary or secondary outcomes between breast-fed and formula fed infants. The likelyhood of breastfeeding at 3 months was not significantly different in infants subsequently randomised to bottle A or B. Conclusion Bottle design may have short-term effects on infant behaviour which merit further investigation. No significant effects were seen on milk intake or growth; confidence in these findings is limited by the small sample size and this needs confirmation in a larger study. Trial registration Clinical Trials.gov NCT00325208.

  4. Experiences from a randomised, controlled trial on cycling to school: does cycling increase cardiorespiratory fitness?

    OpenAIRE

    Børrestad, Line Anita Bjørkelund; Østergaard, Lars; Andersen, Lars Bo; Bere, Elling

    2012-01-01

    Aims: The objective of the present study was to investigate the effect of a 12-week randomised controlled cycling-to-school trial on cardiorespiratory fitness. Methods: A total of 53 10- to 13-year-old children from one public school were included. The children were randomised into either a cycling group or a control group. The cycling group was encouraged to cycle to and from school each day during a period of 12 weeks. Peak oxygen consumption (VO2peak) and anthropometrical data (weight and ...

  5. Randomised clinical trial of Levonantradol and Chlorpromazine in the prevention of radiotherapy-induced vomiting

    Energy Technology Data Exchange (ETDEWEB)

    Lucraft, H.H.; Palmer, M.K. (Christie Hospital and Holt Radium Inst., Manchester (UK))

    1982-11-01

    Levonantradol is a cannabis derivative. Cannabinoid anti-emetics are being assessed in cancer chemotherapy but have been little used in radiotherapy to date. A pilot study and randomised trial compared the anti-emetic effect of a standard drug (Chlorpromazine 25 mg) with Levonantradol at two doses (0.5 and 0.75 mg) in patients receiving palliative single fraction radiotherapy to sites likely to cause nausea and vomiting. Most patients were out-patients. Both drugs were well tolerated. The frequency of vomiting was similar in all three groups in both the pilot study and randomised trial.

  6. Randomised comparison of coronary stenting with and without balloon predilatation in selected patients

    OpenAIRE

    Le Breton, H; Boschat, J; Commeau, P; Brunel, P.; Gilard, M; Breut, C; Bar, O.; Geslin, P; Tirouvanziam, A; Maillard, L.; Moquet, B; Barragan, P.; Dupouy, P.; Grollier, G; Berland, J.

    2001-01-01

    BACKGROUND—The SWIBAP (stent without balloon predilatation) prospective randomised trial was designed to compare direct coronary stenting with stenting preceded by lesion predilatation with an angioplasty balloon.
OBJECTIVE—To determine the feasibility and safety of direct stenting in non-complex coronary lesions in a prospective study.
PATIENTS AND DESIGN—All patients  3.0 mm, who granted their informed consent, were randomised into the trial. In group I, the stent was placed without balloon...

  7. Inflammatory markers in a randomised soya intervention among men.

    Science.gov (United States)

    Maskarinec, Gertraud; Oum, Robert; Chaptman, Ann K; Ognjanovic, Simona

    2009-06-01

    The present analysis investigated the effect of soya foods on serum levels of six inflammatory markers, leptin, adiponectin, monocyte attractant protein 1 (MCP-1), macrophage inflammatory protein-1b (MIP-1b), IL-6 and C-reactive protein (CRP), and their relationship with BMI and lifetime soya intake. We randomised twenty-four men to a high- (two daily servings with 30-35 mg isoflavones per serving) or a low-soya diet for 3 months. After a 1-month washout period, the men crossed over to the other treatment. We used a multiplex bead immunoassay to measure leptin, adiponectin, MCP-1 and MIP-1b and ELISA assays for IL-6 and CRP. The statistical analysis applied mixed models that incorporated the four repeated measurements. The men had a mean age of 58.7 (sd 7.2) years and a mean BMI of 28.4 (sd 4.9) kg/m2. We observed no significant intervention effect of the soya treatment on any of the six markers. After adjustment for age and ethnicity, highly significant associations of BMI and body weight with leptin and MCP-1 emerged. Men with high soya intake early in life also had higher levels of leptin and MCP-1, whereas no association was seen for soya intake during adulthood. MIP-1b, adiponectin, IL-6 and CRP were not related to BMI, body weight or soya intake at any time in life. No intervention effect of soya foods on markers of inflammation was observed in this small study, but adiposity and early-life soya intake were related to higher leptin and MCP-1 levels.

  8. Acupuncture for dry eye: a randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Kim Ae-Ran

    2009-12-01

    Full Text Available Abstract Background Dry eye is usually managed by conventional medical interventions such as artificial tears, anti-inflammatory drugs and surgical treatment. However, since dry eye is one of the most frequent ophthalmologic disorders, safer and more effective methods for its treatment are necessary, especially for vulnerable patients. Acupuncture has been widely used to treat patients with dry eye. Our aim is to evaluate the effectiveness and safety of acupuncture for this condition. Methods/Design A randomised, patient-assessor blinded, sham (non-acupuncture point, shallow acupuncture controlled study was established. Participants allocated to verum acupuncture and sham acupuncture groups will be treated three times weekly for three weeks for a total of nine sessions per participant. Seventeen points (GV23; bilateral BL2, GB4, TE23, Ex1 (Taiyang, ST1 and GB20; and left SP3, LU9, LU10 and HT8 for men, right for women have been selected for the verum acupuncture; for the sham acupuncture, points have been selected that do not coincide with a classical acupuncture point and that are located close to the verum points, except in the case of the rim of the eye. Ocular surface disease index, tear film breakup time, the Schirmer I test, medication quantification scale and general assessment of improvement will be used as outcome variables for evaluating the effectiveness of acupuncture. Safety will also be assessed at every visit. Primary and secondary outcomes will be assessed four weeks after screening. All statistical analyses will be performed using analysis of covariance. Discussion The results of this trial will be used as a basis for clarifying the efficacy of acupuncture for dry eye. Trial registration ClinicalTrials.gov NCT00969280.

  9. Reading and Language Intervention for Children at Risk of Dyslexia: A Randomised Controlled Trial

    Science.gov (United States)

    Duff, Fiona J.; Hulme, Charles; Grainger, Katy; Hardwick, Samantha J.; Miles, Jeremy N. V.; Snowling, Margaret J.

    2014-01-01

    Background: Intervention studies for children at risk of dyslexia have typically been delivered preschool, and show short-term effects on letter knowledge and phoneme awareness, with little transfer to literacy. Methods: This randomised controlled trial evaluated the effectiveness of a reading and language intervention for 6-year-old children…

  10. Exercise therapy for Stress-related mental disorder, a randomised controlled trial in primary care

    NARCIS (Netherlands)

    Quartero, A. Otto; Burger, Huib; Donker, Marieke; de Wit, Niek J.

    2011-01-01

    Background: to investigate whether a structured physical exercise programme (PEP) improves the recovery of general health in patients suffering from Stress-related Mental Disorder (SMD). Method: Study design: randomised open trial in general practice. Patients from two regions in the Netherlands wer

  11. Randomised controlled trial of topical kanuka honey for the treatment of rosacea

    NARCIS (Netherlands)

    Braithwaite, Irene; Hunt, Anna; Riley, Judith; Fingleton, James; Kocks, Janwillem; Corin, Andrew; Helm, Colin; Sheahan, Davitt; Tofield, Christopher; Montgomery, Barney; Holliday, Mark; Weatherall, Mark; Beasley, Richard

    2015-01-01

    OBJECTIVE: To investigate the efficacy of topical 90% medical-grade kanuka honey and 10% glycerine (Honevo) as a treatment for rosacea. DESIGN: Randomised controlled trial with blinded assessment of primary outcome variable. SETTING: Outpatient primary healthcare population from 5 New Zealand sites.

  12. Supervised exercise therapy versus usual care for patellofemoral pain syndrome: an open label randomised controlled trial.

    NARCIS (Netherlands)

    R. van Linschoten (Robbart); M. van Middelkoop (Marienke); M.Y. Berger (Marjolein); E.M. Heintjes (Edith); J.A.N. Verhaar (Jan); S.P. Willemsen (Sten); B.W. Koes (Bart); S.M. Bierma-Zeinstra (Sita)

    2009-01-01

    textabstractOBJECTIVE: To assess the effectiveness of supervised exercise therapy compared with usual care with respect to recovery, pain, and function in patients with patellofemoral pain syndrome. DESIGN: Open label randomised controlled trial. SETTING: General practice and sport physician practic

  13. 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

  14. Review of Randomised Controlled Trials of Internet Interventions for Mental Disorders and Related Conditions

    Science.gov (United States)

    Griffiths, Kathleen M.; Christensen, Helen

    2006-01-01

    Self-help Internet interventions have the potential to enable consumers to play a central role in managing their own health. This paper contains a systematic review of 15 randomised controlled trials of the effectiveness of self-help Internet interventions for mental disorders and related conditions. Conditions addressed by the interventions…

  15. TIPP and Lichtenstein modalities for inguinal hernia repair: a cost minimisation analysis alongside a randomised trial

    NARCIS (Netherlands)

    Koning, G.G.; Adang, E.M.M.; Stalmeier, P.F.M.; Keus, F.; Vriens, P.W.H.E.; Laarhoven, C.J.H.M. van

    2013-01-01

    The transinguinal preperitoneal (TIPP) technique using a soft mesh with a memory ring was developed recently for inguinal hernia repair. To compare TIPP with the Lichtenstein method, a randomised trial was conducted (ISRCTN93798494). The aim of this study was to perform an economic evaluation of the

  16. TIPP and Lichtenstein modalities for inguinal hernia repair : a cost minimisation analysis alongside a randomised trial

    NARCIS (Netherlands)

    Koning, G. G.; Adang, E. M. M.; Stalmeier, P. F. M.; Keus, F.; Vriens, P. W. H. E.; van Laarhoven, C. J. H. M.

    2013-01-01

    The transinguinal preperitoneal (TIPP) technique using a soft mesh with a memory ring was developed recently for inguinal hernia repair. To compare TIPP with the Lichtenstein method, a randomised trial was conducted (ISRCTN93798494). The aim of this study was to perform an economic evaluation of the

  17. Comments on: The effects of sitagliptin on gastric emptying in healthy humans - a randomised, controlled study

    Directory of Open Access Journals (Sweden)

    Ekaterina A Pigarova

    2012-06-01

    Full Text Available Comments on: Stevens JE, Horowitz M, Deacon CF, Nauck M, Rayner CK, Jones KL. The effects of sitagliptin on gastric emptying in healthy humans - a randomised, controlled study. Aliment Pharmacol Ther. 2012 Jun 28. doi: 10.1111/j.1365-2036.2012.05198.x

  18. Patient safety in elderly hip fracture patients: design of a randomised controlled trial.

    NARCIS (Netherlands)

    Merten, H.; Lubberding, S.; Wagtendonk, I. van; Johannesma, P.C.; Wagner, C.

    2011-01-01

    BACKGROUND: The clinical environment in which health care providers have to work everyday is highly complex; this increases the risk for the occurrence of unintended events. The aim of this randomised controlled trial is to improve patient safety for a vulnerable group of patients that have to go th

  19. Stress in Fathers of Moderately and Late Preterm Infants: A Randomised Controlled Trial

    Science.gov (United States)

    Ravn, Ingrid Helen; Lindemann, Rolf; Smeby, Nina Aarhus; Bunch, Eli Haugen; Sandvik, Leiv; Smith, Lars

    2012-01-01

    The atypical behaviour of preterm infants can elicit stress in fathers and influence their ability to perceive and interpret infants' cues. This study investigated whether fathers of moderately and late preterm infants were more stressed than fathers of term infants. In a randomised controlled trial, we also studied the effect of the Mother-Infant…

  20. Ventilation strategies and outcome in randomised trials of high frequency ventilation

    OpenAIRE

    Thome, U; Carlo, W; Pohlandt, F

    2005-01-01

    Objective: Randomised controlled trials comparing elective use of high frequency ventilation (HFV) with conventional mechanical ventilation (CMV) in preterm infants have yielded conflicting results. We hypothesised that the variability of results may be explained by differences in study design, ventilation strategies, delay in initiation of HFV, and use of permissive hypercapnia.

  1. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

    NARCIS (Netherlands)

    O’Cathain, A.; Hoddinott, P.; Lewin, S.; Thomas, K.J.; Young, B.; Adamson, J.; Jansen, J.F.M.; Mills, N.; Moore, G.; Donovan, J.L.

    2015-01-01

    Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full t

  2. Effect of virtual reality training on laparoscopic surgery: randomised controlled trial

    OpenAIRE

    Larsen, Christian R; Soerensen, Jette L; Grantcharov, Teodor P; Dalsgaard, Torur; Schouenborg, Lars; Ottosen, Christian; Torben V. Schroeder; Ottesen, Bent S

    2009-01-01

    Objective To assess the effect of virtual reality training on an actual laparoscopic operation. Design Prospective randomised controlled and blinded trial. Setting Seven gynaecological departments in the Zeeland region of Denmark. Participants 24 first and second year registrars specialising in gynaecology and obstetrics. Interventions Proficiency based virtual reality simulator training in laparoscopic salpingectomy and standard clinical education (controls). Main outcome measure The main ou...

  3. Moderate alcohol consumption increases insulin sensitivity and ADIPOQ expression in postmenopausal women: A randomised, crossover trial

    NARCIS (Netherlands)

    Joosten, M.M.; Beulens, J.W.J.; Kersten, S.; Hendriks, H.F.J.

    2008-01-01

    Aims/hypothesis: To determine whether 6 weeks of daily, moderate alcohol consumption increases expression of the gene encoding adiponectin (ADIPOQ) and plasma levels of the protein, and improves insulin sensitivity in postmenopausal women. Methods: In a randomised, open-label, crossover trial conduc

  4. Skills Training to Avoid Inadvertent Plagiarism: Results from a Randomised Control Study

    Science.gov (United States)

    Newton, Fiona J.; Wright, Jill D.; Newton, Joshua D.

    2014-01-01

    Plagiarism continues to be a concern within academic institutions. The current study utilised a randomised control trial of 137 new entry tertiary students to assess the efficacy of a scalable short training session on paraphrasing, patch writing and plagiarism. The results indicate that the training significantly enhanced students' overall…

  5. Improved interobserver variation after training of doctors in the Neer system. A randomised trial

    DEFF Research Database (Denmark)

    Brorson, S; Bagger, J; Sylvest, A;

    2002-01-01

    We investigated whether training doctors to classify proximal fractures of the humerus according to the Neer system could improve interobserver agreement. Fourteen doctors were randomised to two training sessions, or to no training, and asked to categorise 42 unselected pairs of plain radiographs...

  6. Community based occupational therapy for patients with dementia and their care givers: randomised controlled trial.

    NARCIS (Netherlands)

    Graff, M.J.L.; Vernooij-Dassen, M.J.F.J.; Thijssen, M.; Dekker, J.; Hoefnagels, W.H.L.; Olde Rikkert, M.G.M.

    2006-01-01

    OBJECTIVE: To determine the effectiveness of community based occupational therapy on daily functioning of patients with dementia and the sense of competence of their care givers. DESIGN: Single blind randomised controlled trial. Assessors were blinded for treatment allocation. SETTING: Memory clinic

  7. Targeting cancer patients' quality of life through social comparison : A randomised trial

    NARCIS (Netherlands)

    Brakel, Thecla M.; Dijkstra, Arie; Buunk, Abraham P.

    2014-01-01

    Objective: Former cancer patients' quality of life can be improved by offering social comparison information. Whether patients, however, benefit from the information may depend on how negative they perceive their present and their future. Design: We conducted a randomised experimental field study wi

  8. Feather bedding and childhood asthma associated with house dust mite sensitisation : a randomised controlled trial

    NARCIS (Netherlands)

    Glasgow, Nicholas J.; Ponsonby, Anne-Louise; Kemp, Andrew; Tovey, Euan; van Asperen, Peter; McKay, Karen; Forbes, Samantha

    2011-01-01

    Introduction Observational studies report inverse associations between the use of feather upper bedding (pillow and/or quilt) and asthma symptoms but there is no randomised controlled trial (RCT) evidence assessing the role of feather upper bedding as a secondary prevention measure. Objective To det

  9. Conductive Education as a Method of Stroke Rehabilitation: A Single Blinded Randomised Controlled Feasibility Study

    Directory of Open Access Journals (Sweden)

    Judith Bek

    2016-01-01

    Full Text Available Background. Conductive Education for stroke survivors has shown promise but randomised evidence is unavailable. This study assessed the feasibility of a definitive randomised controlled trial to evaluate efficacy. Methods. Adult stroke survivors were recruited through local community notices. Those completing the baseline assessment were randomised using an online program and group allocation was independent. Intervention group participants received 10 weekly 1.5-hour sessions of Conductive Education at the National Institute of Conductive Education in Birmingham, UK. The control group participants attended two group meetings. The study evaluated the feasibility of recruitment procedures, delivery of the intervention, retention of participants, and appropriateness of outcome measures and data collection methods. Independent assessments included the Barthel Index, the Stroke Impact Scale, the Timed Up and Go test, and the Hospital Anxiety and Depression Scale. Results. Eighty-two patients were enrolled; 77 completed the baseline assessment (46 men, mean age 62.1 yrs. and were randomised. 70 commenced the intervention (n=37 or an equivalent waiting period (n=33. 32/37 completed the 10-week training and 32/33 the waiting period. There were no missing items from completed questionnaires and no adverse events. Discussion. Recruitment, intervention, and assessment methods worked well. Transport issues for intervention and assessment appointments require review. Conclusion. A definitive trial is feasible. This trial is registered with ISRCTN84064492.

  10. Community based physiotherapeutic exercise in COPD self-management : A randomised controlled trial

    NARCIS (Netherlands)

    Effing, Tanja; Zielhuis, Gerhard; Kerstjens, Huib; van der Valk, Paul; van der Palen, Job

    2011-01-01

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

  11. Vibration therapy reduces CPAP need in a prospective randomised controlled trial

    NARCIS (Netherlands)

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

    2008-01-01

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

  12. The matching quality of experimental and control interventions in blinded pharmacological randomised clinical trials

    DEFF Research Database (Denmark)

    Bello, Segun; Wei, Maoling; Hilden, Jørgen;

    2016-01-01

    Background: Blinding is a pivotal method to avoid bias in randomised clinical trials. In blinded drug trials, experimental and control interventions are often designed to be matched, i.e. to appear indistinguishable. It is unknown how often matching procedures are inadequate, so we decided...

  13. Comparison of Bobath based and movement science based treatment for stroke: a randomised controlled trial

    OpenAIRE

    van Vliet, P M; Lincoln, N.; Foxall, A

    2005-01-01

    Objectives: Bobath based (BB) and movement science based (MSB) physiotherapy interventions are widely used for patients after stroke. There is little evidence to suggest which is most effective. This single-blind randomised controlled trial evaluated the effect of these treatments on movement abilities and functional independence.

  14. Cervical collar or physiotherapy versus wait and see policy for recent onset cervical radiculopathy: randomised trial

    NARCIS (Netherlands)

    B. Kuijper; J.T.J. Tans; A. Beelen; F. Nollet; M. de Visser

    2009-01-01

    Objective To evaluate the effectiveness of treatment with collar or physiotherapy compared with a wait and see policy in recent onset cervical radiculopathy. Design Randomised controlled trial. Setting Neurology outpatient clinics in three Dutch hospitals. Participants 205 patients with symptoms and

  15. Cervical collar or physiotherapy versus wait and see policy for recent onset cervical radiculopathy: randomised trial.

    NARCIS (Netherlands)

    B. Kuijper (Barbara); J.T. Tans; A. Beelen (Anita); F. Nollet (Frans); M. de Visser (Marianne)

    2009-01-01

    textabstractOBJECTIVE: To evaluate the effectiveness of treatment with collar or physiotherapy compared with a wait and see policy in recent onset cervical radiculopathy. DESIGN: Randomised controlled trial. SETTING: Neurology outpatient clinics in three Dutch hospitals. PARTICIPANTS: 205 patients w

  16. Low quality of reporting adverse drug reactions in paediatric randomised controlled trials

    NARCIS (Netherlands)

    de Vries, Tjalling W; van Roon, Eric N

    2010-01-01

    OBJECTIVE: Randomised controlled trials (RCT) offer an opportunity to learn about frequency and character of adverse drug reactions. To improve the quality of reporting adverse effects, the Consort group published recommendations. The authors studied the application of these recommendations in RCTs

  17. A prospective randomised controlled clinical trial comparing somatostatin and vasopressin in controlling acute variceal haemorrhage.

    OpenAIRE

    S. A. Jenkins; Baxter, J. N.; Corbett, W; Devitt, P.; Ware, J; Shields, R

    1985-01-01

    Twenty two patients were entered into a randomised controlled clinical trial comparing the efficacy of somatostatin and vasopressin in controlling acute variceal haemorrhage. Somatostatin was significantly more successful in controlling acute variceal haemorrhage than vasopressin (p = 0.003). Furthermore, no complications were observed during treatment with somatostatin.

  18. Outcomes of a multicentre randomised clinical trial of etanercept to treat ankylosing spondylitis.

    NARCIS (Netherlands)

    Calin, A.; Dijkmans, B.A.C.; Emery, P; Hakala, M; Kalden, J; Leirisalo-Repo, M; Mola, EM; Salvarani, C; Sanmarti, R; Sany, J; Sibilia, J; Sieper, J.; Linden, S. ven der; Veys, E; Appel, AM; Fatenejad, S

    2004-01-01

    OBJECTIVE: A double blind, randomised, placebo controlled study to evaluate the safety and efficacy of etanercept to treat adult patients with ankylosing spondylitis (AS). METHODS: Adult patients with AS at 14 European sites were randomly assigned to 25 mg injections of etanercept or placebo twice w

  19. Melatonin for chronic whiplash syndrome with delayed melatonin onset randomised, placebo-controlled trial

    NARCIS (Netherlands)

    Wieringen, S. van; Jansen, T.; Smits, M.G.; Nagtegaal, J.E.; Coenen, A.M.L.

    2001-01-01

    Objective: To assess the influence of melatonin in patients with chronic whiplash syndrome and delayed melatonin onset. Design: Randomised, double-blind, placebo-controlled, parallel-group trial. One-week baseline was followed by a 4-week treatment period with either melatonin or placebo. In the ba

  20. Hysteroscopy before in-vitro fertilisation (inSIGHT) : A multicentre, randomised controlled trial

    NARCIS (Netherlands)

    Smit, Janine G.; Kasius, Jenneke C.; Eijkemans, Marinus J C; Koks, Carolien A M; van Golde, Ronald; Nap, Annemiek W.; Scheffer, Gabrielle J.; Manger, Petra A P; Hoek, Annemieke; Schoot, Benedictus C.; van Heusden, Arne M.; Kuchenbecker, Walter K H; Perquin, Denise A M; Fleischer, Kathrin; Kaaijk, Eugenie M.; Sluijmer, Alexander; Friederich, Jaap; Dykgraaf, Ramon H M; van Hooff, Marcel; Louwe, Leonie A.; Kwee, Janet; de Koning, Corry H.; Janssen, Ineke C A H; Mol, Femke; Mol, Ben W J; Broekmans, Frank J M; Torrance, Helen L.

    2016-01-01

    BACKGROUND: Hysteroscopy is often done in infertile women starting in-vitro fertilisation (IVF) to improve their chance of having a baby. However, no data are available from randomised controlled trials to support this practice. We aimed to assess whether routine hysteroscopy before the first IVF tr

  1. Hysteroscopy before in-vitro fertilisation (inSIGHT) : a multicentre, randomised controlled trial

    NARCIS (Netherlands)

    Smit, Janine G; Kasius, Jenneke C; Eijkemans, Marinus J C; Koks, Carolien A M; van Golde, Ronald; Nap, Annemiek W; Scheffer, Gabrielle J; Manger, Petra A P; Hoek, Annemieke; Schoot, Benedictus C; van Heusden, Arne M; Kuchenbecker, Walter K H; Perquin, Denise A M; Fleischer, Kathrin; Kaaijk, Eugenie M; Sluijmer, Alexander; Friederich, Jaap; Dykgraaf, Ramon H M; van Hooff, Marcel; Louwe, Leonie A; Kwee, Janet; de Koning, Corry H; Janssen, Ineke C A H; Mol, Femke; Mol, Ben W J; Broekmans, Frank J M; Torrance, Helen L

    2016-01-01

    BACKGROUND: Hysteroscopy is often done in infertile women starting in-vitro fertilisation (IVF) to improve their chance of having a baby. However, no data are available from randomised controlled trials to support this practice. We aimed to assess whether routine hysteroscopy before the first IVF tr

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

    LENUS (Irish Health Repository)

    Hung, Chi-Fa

    2014-07-01

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

  3. 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

  4. Effect of unsupervised home based proprioceptive training on recurrences of ankle sprain: randomised controlled trial

    NARCIS (Netherlands)

    Hupperets, M.D.W.; Verhagen, E.A.L.M.; Mechelen, van W.

    2009-01-01

    OBJECTIVE: To evaluate the effectiveness of an unsupervised proprioceptive training programme on recurrences of ankle sprain after usual care in athletes who had sustained an acute sports related injury to the lateral ankle ligament. DESIGN: Randomised controlled trial, with one year follow-up. SETT

  5. Randomised controlled trial of magnetic-resonance pelvimetry in breech presentation at term

    NARCIS (Netherlands)

    van Loon, AJ; Mantingh, A; Serlier, EK; Kroon, G; Mooyaart, EL; Huisjes, HJ

    1997-01-01

    Background Pelvimetry is widely used in women with breech presentation at term to select those for whom planned vaginal delivery is appropriate. However, its clinical value has never been established, We evaluated pelvimetry in a randomised controlled trial. The main outcome measures were the electi

  6. Induction versus expectant monitoring for intrauterine growth restriction at term : randomised equivalence trial (DIGITAT)

    NARCIS (Netherlands)

    Boers, K. E.; Vijgen, S. M. C.; Bijlenga, D.; van der Post, J. A. M.; Bekedam, D. J.; Kwee, A.; van der Salm, P. C. M.; van Pampus, M. G.; Spaanderman, M. E. A.; de Boer, K.; Duvekot, J. J.; Bremer, H. A.; Hasaart, T. H. M.; Delemarre, F. M. C.; Bloemenkamp, K. W. M.; van Meir, C. A.; Willekes, C.; Wijnen, E. J.; Rijken, M.; le Cessie, S.; Roumen, F. J. M. E.; Thornton, J. G.; van Lith, J. M. M.; Mol, B. W. J.; Scherjon, S. A.

    2010-01-01

    Objective To compare the effect of induction of labour with a policy of expectant monitoring for intrauterine growth restriction near term. Design Multicentre randomised equivalence trial (the Disproportionate Intrauterine Growth Intervention Trial At Term (DIGITAT)). Setting Eight academic and 44 n

  7. The Procalcitonin And Survival Study (PASS – A Randomised multi-center investigator-initiated trial to investigate whether daily measurements biomarker Procalcitonin and pro-active diagnostic and therapeutic responses to abnormal Procalcitonin levels, can improve survival in intensive care unit patients. Calculated sample size (target population: 1000 patients

    Directory of Open Access Journals (Sweden)

    Fjeldborg Paul

    2008-07-01

    Full Text Available Abstract Background Sepsis and complications to sepsis are major causes of mortality in critically ill patients. Rapid treatment of sepsis is of crucial importance for survival of patients. The infectious status of the critically ill patient is often difficult to assess because symptoms cannot be expressed and signs may present atypically. The established biological markers of inflammation (leucocytes, C-reactive protein may often be influenced by other parameters than infection, and may be unacceptably slowly released after progression of an infection. At the same time, lack of a relevant antimicrobial therapy in an early course of infection may be fatal for the patient. Specific and rapid markers of bacterial infection have been sought for use in these patients. Methods Multi-centre randomized controlled interventional trial. Powered for superiority and non-inferiority on all measured end points. Complies with, "Good Clinical Practice" (ICH-GCP Guideline (CPMP/ICH/135/95, Directive 2001/20/EC. Inclusion: 1 Age ≥ 18 years of age, 2 Admitted to the participating intensive care units, 3 Signed written informed consent. Exclusion: 1 Known hyper-bilirubinaemia. or hypertriglyceridaemia, 2 Likely that safety is compromised by blood sampling, 3 Pregnant or breast feeding. Computerized Randomisation: Two arms (1:1, n = 500 per arm: Arm 1: standard of care. Arm 2: standard of care and Procalcitonin guided diagnostics and treatment of infection. Primary Trial Objective: To address whether daily Procalcitonin measurements and immediate diagnostic and therapeutic response on day-to-day changes in procalcitonin can reduce the mortality of critically ill patients. Discussion For the first time ever, a mortality-endpoint, large scale randomized controlled trial with a biomarker-guided strategy compared to the best standard of care, is conducted in an Intensive care setting. Results will, with a high statistical power answer the question: Can the survival

  8. Plasma urate concentration and risk of coronary heart disease: a Mendelian randomisation analysis

    Science.gov (United States)

    White, Jon; Sofat, Reecha; Hemani, Gibran; Shah, Tina; Engmann, Jorgen; Dale, Caroline; Shah, Sonia; Kruger, Felix A; Giambartolomei, Claudia; Swerdlow, Daniel I; Palmer, Tom; McLachlan, Stela; Langenberg, Claudia; Zabaneh, Delilah; Lovering, Ruth; Cavadino, Alana; Jefferis, Barbara; Finan, Chris; Wong, Andrew; Amuzu, Antoinette; Ong, Ken; Gaunt, Tom R; Warren, Helen; Davies, Teri-Louise; Drenos, Fotios; Cooper, Jackie; Ebrahim, Shah; Lawlor, Debbie A; Talmud, Philippa J; Humphries, Steve E; Power, Christine; Hypponen, Elina; Richards, Marcus; Hardy, Rebecca; Kuh, Diana; Wareham, Nicholas; Ben-Shlomo, Yoav; Day, Ian N; Whincup, Peter; Morris, Richard; Strachan, Mark W J; Price, Jacqueline; Kumari, Meena; Kivimaki, Mika; Plagnol, Vincent; Whittaker, John C; Smith, George Davey; Dudbridge, Frank; Casas, Juan P; Holmes, Michael V; Hingorani, Aroon D

    2016-01-01

    Summary Background Increased circulating plasma urate concentration is associated with an increased risk of coronary heart disease, but the extent of any causative effect of urate on risk of coronary heart disease is still unclear. In this study, we aimed to clarify any causal role of urate on coronary heart disease risk using Mendelian randomisation analysis. Methods We first did a fixed-effects meta-analysis of the observational association of plasma urate and risk of coronary heart disease. We then used a conventional Mendelian randomisation approach to investigate the causal relevance using a genetic instrument based on 31 urate-associated single nucleotide polymorphisms (SNPs). To account for potential pleiotropic associations of certain SNPs with risk factors other than urate, we additionally did both a multivariable Mendelian randomisation analysis, in which the genetic associations of SNPs with systolic and diastolic blood pressure, HDL cholesterol, and triglycerides were included as covariates, and an Egger Mendelian randomisation (MR-Egger) analysis to estimate a causal effect accounting for unmeasured pleiotropy. Findings In the meta-analysis of 17 prospective observational studies (166 486 individuals; 9784 coronary heart disease events) a 1 SD higher urate concentration was associated with an odds ratio (OR) for coronary heart disease of 1·07 (95% CI 1·04–1·10). The corresponding OR estimates from the conventional, multivariable adjusted, and Egger Mendelian randomisation analysis (58 studies; 198 598 individuals; 65 877 events) were 1·18 (95% CI 1·08–1·29), 1·10 (1·00–1·22), and 1·05 (0·92–1·20), respectively, per 1 SD increment in plasma urate. Interpretation Conventional and multivariate Mendelian randomisation analysis implicates a causal role for urate in the development of coronary heart disease, but these estimates might be inflated by hidden pleiotropy. Egger Mendelian randomisation analysis, which accounts for

  9. 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

  10. Testing the activitystat hypothesis: a randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Gomersall Sjaan

    2012-10-01

    Full Text Available Abstract Background The activitystat hypothesis proposes that when physical activity or energy expenditure is increased or decreased in one domain, there will be a compensatory change in another domain to maintain an overall, stable level of physical activity or energy expenditure. To date, there has been no experimental study primarily designed to test the activitystat hypothesis in adults. The aim of this trial is to determine the effect of two different imposed exercise loads on total daily energy expenditure and physical activity levels. Methods This study will be a randomised, multi-arm, parallel controlled trial. Insufficiently active adults (as determined by the Active Australia survey aged 18–60 years old will be recruited for this study (n=146. Participants must also satisfy the Sports Medicine Australia Pre-Exercise Screening System and must weigh less than 150 kg. Participants will be randomly assigned to one of three groups using a computer-generated allocation sequence. Participants in the Moderate exercise group will receive an additional 150 minutes of moderate to vigorous physical activity per week for six weeks, and those in the Extensive exercise group will receive an additional 300 minutes of moderate to vigorous physical activity per week for six weeks. Exercise targets will be accumulated through both group and individual exercise sessions monitored by heart rate telemetry. Control participants will not be given any instructions regarding lifestyle. The primary outcome measures are activity energy expenditure (doubly labeled water and physical activity (accelerometry. Secondary measures will include resting metabolic rate via indirect calorimetry, use of time, maximal oxygen consumption and several anthropometric and physiological measures. Outcome measures will be conducted at baseline (zero weeks, mid- and end-intervention (three and six weeks with three (12 weeks and six month (24 week follow-up. All assessors will be

  11. Randomised prior feedback modulates neural signals of outcome monitoring.

    Science.gov (United States)

    Mushtaq, Faisal; Wilkie, Richard M; Mon-Williams, Mark A; Schaefer, Alexandre

    2016-01-15

    Substantial evidence indicates that decision outcomes are typically evaluated relative to expectations learned from relatively long sequences of previous outcomes. This mechanism is thought to play a key role in general learning and adaptation processes but relatively little is known about the determinants of outcome evaluation when the capacity to learn from series of prior events is difficult or impossible. To investigate this issue, we examined how the feedback-related negativity (FRN) is modulated by information briefly presented before outcome evaluation. The FRN is a brain potential time-locked to the delivery of decision feedback and it is widely thought to be sensitive to prior expectations. We conducted a multi-trial gambling task in which outcomes at each trial were fully randomised to minimise the capacity to learn from long sequences of prior outcomes. Event-related potentials for outcomes (Win/Loss) in the current trial (Outcomet) were separated according to the type of outcomes that occurred in the preceding two trials (Outcomet-1 and Outcomet-2). We found that FRN voltage was more positive during the processing of win feedback when it was preceded by wins at Outcomet-1 compared to win feedback preceded by losses at Outcomet-1. However, no influence of preceding outcomes was found on FRN activity relative to the processing of loss feedback. We also found no effects of Outcomet-2 on FRN amplitude relative to current feedback. Additional analyses indicated that this effect was largest for trials in which participants selected a decision different to the gamble chosen in the previous trial. These findings are inconsistent with models that solely relate the FRN to prediction error computation. Instead, our results suggest that if stable predictions about future events are weak or non-existent, then outcome processing can be determined by affective systems. More specifically, our results indicate that the FRN is likely to reflect the activity of positive

  12. Normal tissue complication probability (NTCP) parameters for breast fibrosis: Pooled results from two randomised trials

    International Nuclear Information System (INIS)

    Introduction: The dose–volume effect of radiation therapy on breast tissue is poorly understood. We estimate NTCP parameters for breast fibrosis after external beam radiotherapy. Materials and methods: We pooled individual patient data of 5856 patients from 2 trials including whole breast irradiation followed with or without a boost. A two-compartment dose volume histogram model was used with boost volume as the first compartment and the remaining breast volume as second compartment. Results from START-pilot trial (n = 1410) were used to test the predicted models. Results: 26.8% patients in the Cambridge trial (5 years) and 20.7% patients in the EORTC trial (10 years) developed moderate-severe breast fibrosis. The best fit NTCP parameters were BEUD3(50) = 136.4 Gy, γ50 = 0.9 and n = 0.011 for the Niemierko model and BEUD3(50) = 132 Gy, m = 0.35 and n = 0.012 for the Lyman Kutcher Burman model. The observed rates of fibrosis in the START-pilot trial agreed well with the predicted rates. Conclusions: This large multi-centre pooled study suggests that the effect of volume parameter is small and the maximum RT dose is the most important parameter to influence breast fibrosis. A small value of volume parameter ‘n’ does not fit with the hypothesis that breast tissue is a parallel organ. However, this may reflect limitations in our current scoring system of fibrosis

  13. Cost effectiveness of home ultraviolet B phototherapy for psoriasis : economic evaluation of a randomised controlled trial (PLUTO study)

    NARCIS (Netherlands)

    Koek, Mayke B. G.; Sigurdsson, Vigfus; van Weelden, Huib; Steegmans, Paul H. A.; Bruijnzeel-Koomen, Carla A. F. M.; Buskens, Erik

    2010-01-01

    Objective To assess the costs and cost effectiveness of phototherapy with ultraviolet B light provided at home compared with outpatient ultraviolet B phototherapy for psoriasis. Design Cost utility, cost effectiveness, and cost minimisation analyses performed alongside a pragmatic randomised clinica

  14. Fusidic acid cream in the treatment of impetigo in general practice: double blind randomised placebo controlled trial

    NARCIS (Netherlands)

    S. Koning (Sander); L.W.A. van Suijlekom-Smit (Lisette); J.L. Nouwen (Jan); C.M. Verduin (Cees); R.M.D. Bernsen (Roos); A.P. Oranje (Arnold); S. Thomas (Siep); J.C. van der Wouden (Hans)

    2002-01-01

    textabstractOBJECTIVE: To test the hypothesis that fusidic acid would not increase the treatment effect of disinfecting with povidone-iodine alone in children with impetigo. DESIGN: Randomised placebo controlled trial. SETTING: General practices in Greater Rotterdam. PARTICIPANTS:

  15. 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

  16. Obstacles to Gaining Ethical Approval for a Multi-Centre Study of Family Support

    Science.gov (United States)

    MacPherson, Kristen; Lattin-Rawstrone, Rebekah; Senior, Rob; Barnes, Jacqueline

    2005-01-01

    The NHS has emphasised the need for rigorous evaluations of preventative home-visiting support (Bull and others, 2004) in building a public health evidence base. Interdisciplinary studies involving the NHS in any capacity are subject to ethical review by NHS Research Ethics Committees. However, the current process of ethical review does not…

  17. Multi-centre Raman spectral mapping of oesophageal cancer tissues: a study to assess system transferability.

    Science.gov (United States)

    Isabelle, M; Dorney, J; Lewis, A; Lloyd, G R; Old, O; Shepherd, N; Rodriguez-Justo, M; Barr, H; Lau, K; Bell, I; Ohrel, S; Thomas, G; Stone, N; Kendall, C

    2016-06-23

    The potential for Raman spectroscopy to provide early and improved diagnosis on a wide range of tissue and biopsy samples in situ is well documented. The standard histopathology diagnostic methods of reviewing H&E and/or immunohistochemical (IHC) stained tissue sections provides valuable clinical information, but requires both logistics (review, analysis and interpretation by an expert) and costly processing and reagents. Vibrational spectroscopy offers a complimentary diagnostic tool providing specific and multiplexed information relating to molecular structure and composition, but is not yet used to a significant extent in a clinical setting. One of the challenges for clinical implementation is that each Raman spectrometer system will have different characteristics and therefore spectra are not readily compatible between systems. This is essential for clinical implementation where classification models are used to compare measured biochemical or tissue spectra against a library training dataset. In this study, we demonstrate the development and validation of a classification model to discriminate between adenocarcinoma (AC) and non-cancerous intraepithelial metaplasia (IM) oesophageal tissue samples, measured on three different Raman instruments across three different locations. Spectra were corrected using system transfer spectral correction algorithms including wavenumber shift (offset) correction, instrument response correction and baseline removal. The results from this study indicate that the combined correction methods do minimize the instrument and sample quality variations within and between the instrument sites. However, more tissue samples of varying pathology states and greater tissue area coverage (per sample) are needed to properly assess the ability of Raman spectroscopy and system transferability algorithms over multiple instrument sites. PMID:27048868

  18. [Electrical status epilepticus during sleep: a retrospective multi-centre study of 29 cases].

    Science.gov (United States)

    Lorenzo-Ruiz, María; Miguel-Martin, Beatriz; García-Pérez, Asunción; Martínez-Granero, Miguel A; Aguilera-Albesa, Sergio; Yoldi-Petri, M Eugenia; Sánchez-Ruiz de Gordoa, Javier; Castro-De Castro, Pedro; Sánchez-Carpintero, Rocío

    2015-02-01

    Introduccion. El estado epileptico electrico durante el sueño (ESES) es un sindrome epileptico caracterizado por la presencia de descargas epilepticas tipo punta-onda lenta de manera muy persistente durante el sueño no REM. En la actualidad, el manejo de esta patologia es heterogeneo y no hay estudios controlados con los tratamientos utilizados, ni se ha comprobado si estos mejoran la evolucion cognitiva de los pacientes. Pacientes y metodos. Se revisan los pacientes diagnosticados de ESES durante 15 años en cuatro centros hospitalarios, se recoge la presentacion clinica, el manejo terapeutico y la evolucion clinica, y se compara con la bibliografia. Resultados. Se seleccionaron 29 pacientes con ESES, 20 de ellos idiopatico y 26 de ellos generalizado. Los farmacos con los que se consiguio mayor control de la actividad electrica fueron los corticoides/hormona adrenocorticotropa (ACTH), el clobazam y el levetiracetam. La mediana de duracion del ESES en los casos primarios fue de seis meses, y en los secundarios, el doble. El 45% de los pacientes mantuvo un cociente intelectual normal y un 40% presento en la evolucion discapacidad cognitiva de diferente grado. Conclusiones. El pronostico neuropsicologico evolutivo suele ser desfavorable y la evolucion cognitiva parece estar en relacion con la duracion del ESES y el area donde este concentrada la actividad epileptica, lo que sugiere que el mal pronostico, si se trata precozmente, se puede evitar. Los antiepilepticos mas frecuentemente utilizados son el acido valproico, la etosuximida y el levetiracetam, y en nuestra muestra tambien se utilizaron con frecuencia el clobazam y la lamotrigina. Los farmacos mas eficaces para el control del ESES fueron los corticoides/ACTH, el clobazam y el levetiracetam.

  19. The Usher lifestyle survey : maintaining independence: a multi-centre study

    NARCIS (Netherlands)

    Damen, Godelieve W J A; Krabbe, Paul F M; Kilsby, M; Mylanus, Emmanuel A M

    2005-01-01

    Patients with Usher syndrome face a special set of challenges in order to maintain their independence when their sight and hearing worsen. Three different types of Usher (I, II and III) are distinguished by differences in onset, progression and severity of hearing loss, and by the presence or absenc

  20. Multiple myeloma in Nigeria: a multi-centre epidemiological and biomedical study

    Science.gov (United States)

    Nnonyelum, Odunukwe Nkiruka; Anazoeze, Madu Jude; Eunice, Nnodu Obigeli; Emmanuel, Okocha Onyichide; Stella, Akingbola Titilola; Marcus, Asuquo Inyama; Taiwo, Balogun Modupe; Olufela, Kalejaiye Olufunto; Chinawaeze, Aneke John; Orkuma, Joseph Aondowase; Dalhat, Gwarzo Gwarzo; Otobo, Ujah Innocent

    2015-01-01

    Introduction Myelomatosis is a malignant proliferation of plasma cells in the bone marrow, with relatively high prevalence in African populations. Variation in genetic mutations has been observed in individual patients and may be responsible for differences in disease pattern and treatment outcomes. This study described the presentations and treatment outcomes of multiple myeloma in nigerian. Methods The data was obtained retrospectively from the case notes of 135 patients diagnosed with multiple myeloma from eight tertiary health institutions across the six geopolitical zones of Nigeria from 2005 to 2014. Data analysis was carried out using SPSS 17.0. Results The predominant presentations were bone pain in 97 (74%), nephropathy in 47 (35.9%) and pathological fractures in 58 (44.3%). Sixty-seven percent (67%) of the patients were less than 60 years, and 35% had Bence Jones proteinuria. The overall survival beyond 6 months was 91.3%, mean duration of survival rate was 7.4 months. Majority (66.2%) were on Melphalan alone or on melphalan-containing combinations. A higher packed cell volume (PCV) and total serum protein levels at presentation were associated with increased survival, p=0.033 and 0.036, respectively. Conclusion This study portrayed the importance of detail investigation on the causes of bone pain and anaemia in person's aged 40 years and above. There is a high prevalence of nephropathy in this cohort of patients which needs to be further investigated. Majority of the patients, though < 65 years of age were placed on melphalan-containing combinations, which foreclosed chances of future autologous bone marrow transplantation. PMID:26966488

  1. Diagnostic reference levels in angiography and interventional radiology: A Belgian multi-centre study

    International Nuclear Information System (INIS)

    The purpose of this study was to determine diagnostic reference levels (DRLs) for common angiographic and interventional procedures in Belgium. Dose Area Product (DAP) measurements were performed on 21 systems, (13 angiography and 4 vascular surgery centres). Type of procedure, total DAP, patient weight and height were collected on a daily basis during 1 y. The 75. percentile of the distribution of DAP values was defined as DRL. Preliminary DRLs were calculated for the three most frequent procedures for the whole population, for a weight class of patients (65-80 kg) and normalised to the standard size patient. Among them, the DRL for angiography of the lower limbs (30% of the procedures) from the whole population was 74.6 and 63.2 Gy cm2 for the size corrected. The mean DAP values of each room was then compared to these DRLs. (authors)

  2. Sperm banking for male reproductive preservation: a 6-year retrospective multi-centre study in China.

    Science.gov (United States)

    Ping, Ping; Zhu, Wen-Bing; Zhang, Xin-Zong; Yao, Kang-Shou; Xu, Peng; Huang, Yi-Ran; Li, Zheng

    2010-05-01

    Sperm banking can preserve male fertility effectively, but the current conditions of sperm cryopreservation in China have not been investigated. This retrospective investigation was based on data collected at multiple centres in China from January 2003 to December 2008. The collected data included urogenital history, indication for cryopreservation, semen parameters, use rate, type of assisted reproductive technique (ART) treatment and pregnancy outcome. The study population included 1 548 males who had banked their semen during the study period at one of the clinics indicated above. Approximately 1.9% (30/1 548) of the cryopreserved semen samples were collected from cancer patients; about 88.8% (1 374/1 548) of the patients had banked their semen for ART and 8.6% (134/1 548) had a male infertility disease (such as anejaculation, severe oligozoospermia and obstructive azoospermia). The total use rate of cryopreserved semen was 22.7% (352/1 548), with 119 live births. The cancer group use rate was 6.7% (2/30), with one live birth by intracytoplasmic single sperm injection (ICSI). The ART group use rate was 23.2% (319/1 374), with 106 live births. The reproductive disease group use rate was 23.1% (31/134), with 12 live births. The semen parameters in each category varied; the cancer patient and infertility disease groups had poor semen quality. In vitro fertilization (IVF) and ICSI were the most common ART treatments for cryopreserved sperm. Semen cryopreservation as a salvage method is effective, but in many conditions it is underutilized, especially in cancer patients. Lack of awareness, urgency of cancer treatment and financial constraints are the main causes of the low access rate. The concept of fertility preservation should be popularized to make better use of this medical service in China. PMID:20348941

  3. Alarm Variables for Dengue Outbreaks: A Multi-Centre Study in Asia and Latin America.

    Directory of Open Access Journals (Sweden)

    Leigh R Bowman

    Full Text Available Worldwide, dengue is an unrelenting economic and health burden. Dengue outbreaks have become increasingly common, which place great strain on health infrastructure and services. Early warning models could allow health systems and vector control programmes to respond more cost-effectively and efficiently.The Shewhart method and Endemic Channel were used to identify alarm variables that may predict dengue outbreaks. Five country datasets were compiled by epidemiological week over the years 2007-2013. These data were split between the years 2007-2011 (historic period and 2012-2013 (evaluation period. Associations between alarm/ outbreak variables were analysed using logistic regression during the historic period while alarm and outbreak signals were captured during the evaluation period. These signals were combined to form alarm/ outbreak periods, where 2 signals were equal to 1 period. Alarm periods were quantified and used to predict subsequent outbreak periods. Across Mexico and Dominican Republic, an increase in probable cases predicted outbreaks of hospitalised cases with sensitivities and positive predictive values (PPV of 93%/ 83% and 97%/ 86% respectively, at a lag of 1-12 weeks. An increase in mean temperature ably predicted outbreaks of hospitalised cases in Mexico and Brazil, with sensitivities and PPVs of 79%/ 73% and 81%/ 46% respectively, also at a lag of 1-12 weeks. Mean age was predictive of hospitalised cases at sensitivities and PPVs of 72%/ 74% and 96%/ 45% in Mexico and Malaysia respectively, at a lag of 4-16 weeks.An increase in probable cases was predictive of outbreaks, while meteorological variables, particularly mean temperature, demonstrated predictive potential in some countries, but not all. While it is difficult to define uniform variables applicable in every country context, the use of probable cases and meteorological variables in tailored early warning systems could be used to highlight the occurrence of dengue outbreaks or indicate increased risk of dengue transmission.

  4. Health status of children with cerebral palsy living in Europe: a multi-centre study

    DEFF Research Database (Denmark)

    Beckung, E; White-Koning, M; Marcelli, M;

    2008-01-01

    AIM: The aim of this report is to describe the health status of 8-12-year-old children with cerebral palsy (CP) of all severities in Europe using the Child Health Questionnaire (CHQ). METHOD: A total of 818 children with CP from nine centres in defined geographical areas participated. CP type...

  5. Multi-centre testing and validation of current protocols for the identification of Gyrodactylus salaris (Monogenea).

    Science.gov (United States)

    Shinn, A P; Collins, C; García-Vásquez, A; Snow, M; Matejusová, I; Paladini, G; Longshaw, M; Lindenstrøm, T; Stone, D M; Turnbull, J F; Picon-Camacho, S M; Rivera, C Vázquez; Duguid, R A; Mo, T A; Hansen, H; Olstad, K; Cable, J; Harris, P D; Kerr, R; Graham, D; Monaghan, S J; Yoon, G H; Buchmann, K; Taylor, N G H; Bakke, T A; Raynard, R; Irving, S; Bron, J E

    2010-10-01

    Despite routine screening requirements for the notifiable fish pathogen Gyrodactylus salaris, no standard operating procedure exists for its rapid identification and discrimination from other species of Gyrodactylus. This study assessed screening and identification efficiencies under real-world conditions for the most commonly employed identification methodologies: visual, morphometric and molecular analyses. Obtained data were used to design a best-practice processing and decision-making protocol allowing rapid specimen throughput and maximal classification accuracy. True specimen identities were established using a consensus from all three identification methods, coupled with the use of host and location information. The most experienced salmonid gyrodactylid expert correctly identified 95.1% of G. salaris specimens. Statistical methods of classification identified 66.7% of the G. salaris, demonstrating the need for much wider training. Molecular techniques (internal transcribed spacer region-restriction fragment length polymorphism (ITS-RFLP)/cytochrome c oxidase I (COI) sequencing) conducted in the diagnostic laboratory most experienced in the analysis of gyrodactylid material, identified 100% of the true G. salaris specimens. Taking into account causes of potential specimen loss, the probabilities of a specimen being accurately identified were 95%, 87% and 92% for visual, morphometric and molecular techniques, respectively, and the probabilities of correctly identifying a specimen of G. salaris by each method were 81%, 58% and 92%. Inter-analyst agreement for 189 gyrodactylids assessed by all three methods using Fleiss' Kappa suggested substantial agreement in identification between the methods. During routine surveillance periods when low numbers of specimens are analysed, we recommend that specimens be analysed using the ITS-RFLP approach followed by sequencing of specimens with a "G. salaris-like" (i.e. G. salaris, Gyrodactylus thymalli) banding pattern. During periods of suspected outbreaks, where a high volume of specimens is expected, we recommended that specimens be identified using visual identification, as the fastest processing method, to select "G. salaris-like" specimens, which are subsequently identified by molecular-based techniques.

  6. A multi-centre phase IIa clinical study of predictive testing for preeclampsia

    DEFF Research Database (Denmark)

    Navaratnam, Kate; Alfirevic, Zarko; Baker, Philip N;

    2013-01-01

    5% of first time pregnancies are complicated by pre-eclampsia, the leading cause of maternal death in Europe. No clinically useful screening test exists; consequentially clinicians are unable to offer targeted surveillance or preventative strategies. IMPROvED Consortium members have pioneered...... a personalised medicine approach to identifying blood-borne biomarkers through recent technological advancements, involving mapping of the blood metabolome and proteome. The key objective is to develop a sensitive, specific, high-throughput and economically viable early pregnancy screening test for pre-eclampsia....

  7. Multi-centred mixed-methods PEPFAR HIV care & support public health evaluation: study protocol

    OpenAIRE

    Fayers Peter; Namisango Eve; Mwangi-Powell Faith; Powell Richard A; Downing Julia; Moreland Scott; McCrone Paul; Penfold Suzanne; Simms Victoria; Harding Richard; Curtis Siân; Higginson Irene J

    2010-01-01

    Abstract Background A public health response is essential to meet the multidimensional needs of patients and families affected by HIV disease in sub-Saharan Africa. In order to appraise curret provision of HIV care and support in East Africa, and to provide evidence-based direction to future care programming, and Public Health Evaluation was commissioned by the PEPFAR programme of the US Government. Methods/Design This paper described the 2-Phase international mixed methods study protocol uti...

  8. Suboptimal management of central nervous system infections in children: a multi-centre retrospective study

    Directory of Open Access Journals (Sweden)

    Kelly Christine

    2012-09-01

    Full Text Available Abstract Objective We aimed to audit the regional management of central nervous system (CNS infection in children. Methods The study was undertaken in five district general hospitals and one tertiary paediatric hospital in the Mersey region of the UK. Children admitted to hospital with a suspected CNS infection over a three month period were identified. Children were aged between 4 weeks and 16 years old. Details were recorded from the case notes and electronic records. We measured the appropriateness of management pathways as outlined by national and local guidelines. Results Sixty-five children were identified with a median age of 6 months (range 1 month to 15 years. Ten had a CNS infection: 4 aseptic meningitis, 3 purulent meningitis, 3 encephalitis [2 with herpes simplex virus (HSV type 1]. A lumbar puncture (LP was attempted in 50 (77% cases but only 43 had cerebrospinal fluid (CSF available for analysis. Of these 24 (57% had a complete standard set of tests performed. Fifty eight (89% received a third generation cephalosporin. Seventeen (26% also received aciclovir with no obvious indication in 9 (53%. Only 11 (65% of those receiving aciclovir had CSF herpes virus PCR. Seventeen had cranial imaging and it was the first management step in 14. Treatment lengths of both antibiotics and aciclovir were highly variable: one child with HSV encephalitis was only treated with aciclovir for 7 days. Conclusions The clinical management of children with suspected CNS infections across the Mersey region is heterogeneous and often sub-optimal, particularly for the investigation and treatment of viral encephalitis. National guidelines for the management of viral encephalitis are needed.

  9. Predictors of participation of adolescents with cerebral palsy: A European multi-centre longitudinal study.

    Science.gov (United States)

    Dang, Van Mô; Colver, Allan; Dickinson, Heather O; Marcelli, Marco; Michelsen, Susan I; Parkes, Jackie; Parkinson, Kathryn; Rapp, Marion; Arnaud, Catherine; Nystrand, Malin; Fauconnier, Jérôme

    2014-11-14

    We investigated whether childhood factors that are amenable to intervention (parenting stress, child psychological problems and pain) predicted participation in daily activities and social roles of adolescents with cerebral palsy (CP). We randomly selected 1174 children aged 8-12 years from eight population-based registers of children with CP in six European countries; 743 (63%) agreed to participate. One further region recruited 75 children from multiple sources. These 818 children were visited at home at age 8-12 years, 594 (73%) agreed to follow-up at age 13-17 years. We used the following measures: parent reported stress (Parenting Stress Index Short Form), their child's psychological difficulties (Strength and Difficulties Questionnaire) and frequency and severity of pain; either child or parent reported the child's participation (LIFE Habits questionnaire). We fitted a structural equation model to each of the participation domains, regressing participation in childhood and adolescence on parenting stress, child psychological problems and pain, and regressing adolescent factors on the corresponding childhood factors; models were adjusted for impairment, region, age and gender. Pain in childhood predicted restricted adolescent participation in all domains except Mealtimes and Communication (standardized total indirect effects β -0.05 to -0.18, 0.01

  10. Work related musculoskeletal disorders among hospital nurses in rural Maharashtra, India: a multi centre survey

    Directory of Open Access Journals (Sweden)

    Deepak B. Anap

    2013-04-01

    Full Text Available Nurses have one of the highest rates of MSD of any occupation. Although en number of studies were done to find out prevalence of Work related musculoskeletal disorders (WMSDs among nurses across the world, there is limited information on its prevalence in Rural Maharashtra. This study investigated prevalence of WMSDs, job risk factors and the coping strategies towards reducing the risk of development of WMSDs among nurses from selected hospitals in rural Maharashtra, India. Validated questionnaires were distributed to 250 nurses working rural hospitals across Maharashtra but only 228 questionnaires were returned and 212 complete questionnaires were included for study. On Analysis we found that 89.1% nurses had experienced work-related musculoskeletal pain or discomfort at sometime in their occupational lives. WMSDs was highest in the low back (48.2%, followed by the shoulder (34.6%, neck (33.1 and knee (29 %. Other regions with less prevalence were Thoracic (10.5%, Feet and ankle (7.6%, Elbow ( 1.88% and Hip (1.6 %. Priority was given to getting help to handle heavy patients ( 57.1 %, nursing procedure modification in order to avoid stress injury ( 50.2 % coping strategies. Our study Concluded that high prevalence of LBP, Shoulder, neck and Knee pain over a 12-month period among nurses working in Rural hospitals in Maharashtra state , and certain risk factors like working in same position for long time, bending, twisting, lifting and treating excessive number of patients were strongly associated with WMSDs. [Int J Res Med Sci 2013; 1(2.000: 101-107

  11. Multi-centred mixed-methods PEPFAR HIV care & support public health evaluation: study protocol

    Directory of Open Access Journals (Sweden)

    Fayers Peter

    2010-09-01

    Full Text Available Abstract Background A public health response is essential to meet the multidimensional needs of patients and families affected by HIV disease in sub-Saharan Africa. In order to appraise curret provision of HIV care and support in East Africa, and to provide evidence-based direction to future care programming, and Public Health Evaluation was commissioned by the PEPFAR programme of the US Government. Methods/Design This paper described the 2-Phase international mixed methods study protocol utilising longitudinal outcome measurement, surveys, patient and family qualitative interviews and focus groups, staff qualitative interviews, health economics and document analysis. Aim 1 To describe the nature and scope of HIV care and support in two African countries, including the types of facilities available, clients seen, and availability of specific components of care [Study Phase 1]. Aim 2 To determine patient health outcomes over time and principle cost drivers [Study Phase 2]. The study objectives are as follows. 1 To undertake a cross-sectional survey of service configuration and activity by sampling 10% of the facilities being funded by PEPFAR to provide HIV care and support in Kenya and Uganda (Phase 1 in order to describe care currently provided, including pharmacy drug reviews to determine availability and supply of essential drugs in HIV management. 2 To conduct patient focus group discussions at each of these (Phase 1 to determine care received. 3 To undertake a longitudinal prospective study of 1200 patients who are newly diagnosed with HIV or patients with HIV who present with a new problem attending PEPFAR care and support services. Data collection includes self-reported quality of life, core palliative outcomes and components of care received (Phase 2. 4 To conduct qualitative interviews with staff, patients and carers in order to explore and understand service issues and care provision in more depth (Phase 2. 5 To undertake document analysis to appraise the clinical care procedures at each facility (Phase 2. 6 To determine principle cost drivers including staff, overhead and laboratory costs (Phase 2. Discussion This novel mixed methods protocol will permit transparent presentation of subsequent dataset results publication, and offers a substantive model of protocol design to measure and integrate key activities and outcomes that underpin a public health approach to disease management in a low-income setting.

  12. Multi-centre retrospective analysis of clinical diagnosis and treatment for chronic cough

    Directory of Open Access Journals (Sweden)

    Xiao-ming CHENG

    2011-02-01

    Full Text Available Objective To explore the clinical characteristics and the present status of diagnosis and treatment of chronic cough.Methods The clinical data of 238 in-patients and out-patients of Departments of Respiratory Diseases from 4 teaching hospitals of Chongqing Municipality were collected from Oct.2008 to Dec.2009,and their clinical characteristics,diagnosis and therapeutic effects were retrospectively analyzed.Results A total of 238 patients were enrolled,most of them complained of dry cough and night cough.Throat symptoms were most common,including itching or foreign body sensation,throat discomfort and gastro-oesophageal reflux.Congestion of pharynx and cobblestone like changes in posterior pharyngeal wall were the most common signs in patients with chronic cough.Among all the supplementary examinations,bronchial provocation test resulted in highest positive rate.Etiological diagnosis was done in a total of 254 case-times for diseases leading to chronic cough,among them upper airway cough syndrome(UACS was suspected in 115 case-times.cough variant asthma(CVA in 42 case-times,and cough due to gastroesophageal reflux(GERC in 53 case-times.After the specific treatment targeting UACS,CVA and GERC,in 152 case-times improvement was found after follow-up,including 56,27 and 21 case-times,respectively,with an effective rate of 68.4%(104/152.The final diagnosis for the other 44 case-times with chronic cough was chronic tonsillitis,chronic bronchitis,eosinophilic bronchitis and angiotensin converting enzyme inhibitor(ACEI induced cough.A definite diagnosis was finally made in 148 out of a total of 254 casses,with a diagnostic rate of 58.3%(148/254.Conclusion The final diagnostic rate in etiology of chronic cough is still poor nowadays in our country,and empirical treatment is still the main practice for chronic cough.

  13. Analysis of patient specific dosimetry quality assurance measurements in intensity modulated radiotherapy: A multi centre study

    Directory of Open Access Journals (Sweden)

    Rajesh Kumar

    2014-01-01

    Conclusion: IMRT centers are having random and biased (skewed towards over or under dose distribution of the percentage variation in difference between measured and planned doses. The analysis of results of the IMRT pre-treatment dose verification reveals that there are systematic errors in the chain of IMRT treatment process at a few centers. The dosimetry quality audit prior to commissioning of IMRT may play an important role in avoiding such discrepancies.

  14. Use of deferred consent for severely ill children in a multi-centre phase III trial

    Directory of Open Access Journals (Sweden)

    Boga Mwamvua

    2011-03-01

    Full Text Available Abstract Background Voluntary participation of a subject in research respects a subject's rights, strengthens its ethical conduct, and is formalized by the informed consent process. Clinical trials of life-saving interventions for medical emergencies often necessitate enrolment of patients where prior written individual informed consent is impossible. Although there are regulations and guidelines on protecting subjects in emergency research, these have been criticised for being limited and unnecessarily restrictive. Across Europe and the United States stringent regulations have resulted in a substantial decline of clinical trials involving emergency interventions. Methods We are conducting a trial of fluid resuscitation in children with hypovolaemic shock in six hospitals across three malaria-endemic African countries. The design is pragmatic as children are enrolled on clinical criteria alone and is being conducted in hospitals with facilities typical of many district hospitals across Africa. The trial aims to inform strategy for managing children with febrile illness and features of shock. In order to develop appropriate consent processes for the trial, we conducted a narrative review of current international recommendations for emergency consent. Results Practical or specific guidance was generally sparse or confusing with few examples in the literature to direct our informed consent process. For a sub-group of children who were critically sick or where parents themselves were otherwise too distressed to consider prior written consent, we opted for a modified form of deferred consent. This included verbal assent from guardians at the point of enrolment, with full written consent obtained after stabilising the child. For children who died prior to full written consent, ethical permission was received to waiver full consent. Conclusions In light of the controversy around guidance and regulations in this area we report how and why we have used a modified system of deferred consent in an emergency intervention trial in children. Although approved by all relevant ethics committees and operational in 3 countries in Africa, formal research is now necessary to explore the perceptions and experiences of parents, health workers, researchers and ethics committees of the modified method of deferred consent.

  15. Pain Levels after Local Anaesthetic with or without Hyaluronidase in Carpal Tunnel Release: A Randomised Controlled Trial

    OpenAIRE

    Yeo, G.; Gupta, A; Ding, G.; Skerman, H.; Khatun, M.; Melsom, D.

    2015-01-01

    Purpose. Hyaluronidase is an enzyme that temporarily liquefies the interstitial barrier, allowing easy dispersal of local anaesthetic through cleavage of tissue planes. This prospective, blinded, randomised controlled study investigates the utility of adding hyaluronidase to local anaesthetic in the setting of carpal tunnel release. Methods. 70 consecutive carpal tunnel release patients were recruited and randomised into a control group only receiving local anaesthetic and a hyaluronidase gro...

  16. Effectiveness of an audience response system on orthodontic knowledge retention of undergraduate dental students – a randomised control trial

    OpenAIRE

    Robson, Nicholas; Popat, Hashmat; Richmond, Stephen; Farnell, Damian J. J.

    2016-01-01

    Objective:: To determine the effect of an audience response system (ARS) on knowledge retention of dental students and to gauge student perceptions of using the ARS. Design:: Randomised control study. Setting:: School of Dentistry, Cardiff University. Participants:: Seventy four second-year dental students were stratified by gender and randomised anonymously to one of two groups. Methods:: One group received a lecture on orthodontic terminology and diagnosis in a traditional didactic format a...

  17. Theory of planned behaviour variables and objective walking behaviour do not show seasonal variation in a randomised controlled trial

    OpenAIRE

    Williams, Stefanie L; French, David P.

    2014-01-01

    Background Longitudinal studies have shown that objectively measured walking behaviour is subject to seasonal variation, with people walking more in summer compared to winter. Seasonality therefore may have the potential to bias the results of randomised controlled trials if there are not adequate statistical or design controls. Despite this there are no studies that assess the impact of seasonality on walking behaviour in a randomised controlled trial, to quantify the extent of such bias. Fu...

  18. Prostate cancer - evidence of exercise and nutrition trial (PrEvENT):Study protocol for a randomised controlled feasibility trial

    OpenAIRE

    Hackshaw-McGeagh, Lucy; Lane, J. Athene; Persad, Raj; Gillatt, David; Holly, Jeff M P; Koupparis, Anthony; Rowe, Edward; Johnston, Lyndsey; Cloete, Jenny; Shiridzinomwa, Constance; Abrams, Paul; Penfold, Chris M; Bahl, Amit; Oxley, Jon; Perks, Claire M.

    2016-01-01

    Background: A growing body of observational evidence suggests that nutritional and physical activity interventions are associated with beneficial outcomes for men with prostate cancer, including brisk walking, lycopene intake, increased fruit and vegetable intake and reduced dairy consumption. However, randomised controlled trial data are limited. The 'Prostate Cancer: Evidence of Exercise and Nutrition Trial' investigates the feasibility of recruiting and randomising men diagnosed with local...

  19. 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...

  20. Effect on peer review of telling reviewers that their signed reviews might be posted on the web: randomised controlled trial

    OpenAIRE

    van Rooyen, Susan; Delamothe, Tony; Evans, Stephen J W

    2010-01-01

    Objectives To see whether telling peer reviewers that their signed reviews of original research papers might be posted on the BMJ’s website would affect the quality of their reviews. Design Randomised controlled trial. Setting A large international general medical journal based in the United Kingdom. Participants 541 authors, 471 peer reviewers, and 12 editors. Intervention Consecutive eligible papers were randomised either to have the reviewer’s signed report made available on the BMJ’s webs...

  1. Pharmacist-led management of chronic pain in primary care:results from a randomised controlled exploratory trial

    OpenAIRE

    Bruhn, Hanne; Christine M. Bond; Elliott, Alison M; Hannaford, Philip C; Amanda J Lee; McNamee, Paul; Smith, Blair H; Watson, Margaret C; Holland, Richard; Wright, David

    2013-01-01

    Objectives To compare the effectiveness of pharmacist medication review, with or without pharmacist prescribing, with standard care, for patients with chronic pain. Design An exploratory randomised controlled trial. Setting Six general practices with prescribing pharmacists in Grampian (3) and East Anglia (3). Participants Patients on repeat prescribed pain medication (4815) were screened by general practitioners (GPs), and mailed invitations (1397). 196 were randomised and 180 (92%) complete...

  2. Implementation of physical coordination training and cognitive behavioural training interventions at cleaning workplaces - secondary analyses of a randomised controlled trial

    DEFF Research Database (Denmark)

    Jørgensen, Marie B; Faber, Anne; Jespersen, Tobias;

    2012-01-01

    This study evaluates the implementation of physical coordination training (PCT) and cognitive behavioural training (CBTr) interventions in a randomised controlled trial at nine cleaners' workplaces. Female cleaners (n = 294) were randomised into a PCT, a CBTr or a reference (REF) group. Both 12...... intervention effects, more research on implementation is needed. Trial registration: ISRCTN96241850. Practitioner summary: Both physical coordination training and cognitive behavioural training are potential effective workplace interventions among low educated job groups with high physical work demands...

  3. A prospective randomised trial of four-layer versus short stretch compression bandages for the treatment of venous leg ulcers.

    OpenAIRE

    Scriven, J. M.; Taylor, L. E.; Wood, A. J.; Bell, P R; Naylor, A. R.; London, N. J.

    1998-01-01

    This trial was undertaken to examine the safety and efficacy of four-layer compared with short stretch compression bandages for the treatment of venous leg ulcers within the confines of a prospective, randomised, ethically approved trial. Fifty-three patients were recruited from a dedicated venous ulcer assessment clinic and their individual ulcerated limbs were randomised to receive either a four-layer bandage (FLB)(n = 32) or a short stretch bandage (SSB)(n = 32). The endpoint was a complet...

  4. Effectiveness of quinine versus artemether-lumefantrine for treating uncomplicated falciparum malaria in Ugandan children: randomised trial

    OpenAIRE

    Achan, J.; Tibenderana, J. K.; Kyabayinze, D.; Mangen, F. W.; Kamya, M. R.; Dorsey, G.; D'Alessandro, U; Rosenthal, P. J.; Talisuna, A O

    2009-01-01

    OBJECTIVE: To compare the effectiveness of oral quinine with that of artemether-lumefantrine in treating uncomplicated malaria in children. DESIGN: Randomised, open label effectiveness study. SETTING: Outpatient clinic of Uganda's national referral hospital in Kampala. PARTICIPANTS: 175 children aged 6 to 59 months with uncomplicated malaria. INTERVENTIONS: Participants were randomised to receive oral quinine or artemether-lumefantrine administered by care givers at home. MAIN OUTCOME MEASURE...

  5. New non-randomised model to assess the prevalence of discriminating behaviour: a pilot study on mephedrone

    OpenAIRE

    Schaffer Jay; Deshmukh Nawed; Shah Syeda; Taft Helen; Cross Paul; Nepusz Tamás; Petróczi Andrea; Shane Maryann; Adesanwo Christiana; Barker James; Naughton Declan P

    2011-01-01

    Abstract Background An advantage of randomised response and non-randomised models investigating sensitive issues arises from the characteristic that individual answers about discriminating behaviour cannot be linked to the individuals. This study proposed a new fuzzy response model coined 'Single Sample Count' (SSC) to estimate prevalence of discriminating or embarrassing behaviour in epidemiologic studies. Methods The SSC was tested and compared to the established Forced Response (FR) model ...

  6. Aspirin for primary prevention of cardiovascular events in people with diabetes: meta-analysis of randomised controlled trials

    OpenAIRE

    De Berardis, Giorgia; Sacco, Michele; Strippoli, Giovanni F.M.; Pellegrini, Fabio; Graziano, Giusi; Tognoni, Gianni; Nicolucci, Antonio

    2009-01-01

    Objective To evaluate the benefits and harms of low dose aspirin in people with diabetes and no cardiovascular disease. Design Meta-analysis of randomised controlled trials. Data sources Medline (1966-November 2008), the Cochrane central register of controlled trials (Cochrane Library 2008;issue 4), and reference lists of retrieved articles. Review methods Randomised trials of aspirin compared with placebo or no aspirin in people with diabetes and no pre-existing cardiovascular disease were e...

  7. 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.

  8. Randomised controlled trials may underestimate drug effects: balanced placebo trial design.

    Directory of Open Access Journals (Sweden)

    Karen Lund

    Full Text Available BACKGROUND: It is an inherent assumption in randomised controlled trials that the drug effect can be estimated by subtracting the response during placebo from the response during active drug treatment. OBJECTIVE: To test the assumption of additivity. The primary hypothesis was that the total treatment effect is smaller than the sum of the drug effect and the placebo effect. The secondary hypothesis was that non-additivity was most pronounced in participants with large placebo effects. METHODS: We used a within-subject randomised blinded balanced placebo design and included 48 healthy volunteers (50% males, mean (SD age 23.4 (6.2 years. Experimental pain was induced by injections of hypertonic saline into the masseter muscle. Participants received four injections with hypertonic saline along with lidocaine or matching placebo in randomised order: A: received hypertonic saline/told hypertonic saline; B: received hypertonic saline+lidocaine/told hypertonic saline; C: received hypertonic saline+placebo/told hypertonic saline+pain killer; D: received hypertonic saline+lidocaine/told hypertonic saline+pain killer. The primary outcome measure was the area under the curve (AUC, mm(2 of pain intensity during injections. RESULTS: There was a significant difference between the sum of the drug effect and the placebo effect (mean AUC 6279 mm(2 (95% CI, 4936-7622 and the total treatment effect (mean AUC 5455 mm(2 (95% CI, 4585-6324 (P = 0.049. This difference was larger for participants with large versus small placebo effects (P = 0.015, and the difference correlated significantly with the size of the placebo effect (r = 0.65, P = 0.006. CONCLUSION: Although this study examined placebo effects and not the whole placebo response as in randomised controlled trials, it does suggest that the additivity assumption may be incorrect, and that the estimated drug effects in randomised controlled trials may be underestimated, particularly in studies

  9. Group mindfulness-based intervention for distressing voices: A pragmatic randomised controlled trial.

    Science.gov (United States)

    Chadwick, Paul; Strauss, Clara; Jones, Anna-Marie; Kingdon, David; Ellett, Lyn; Dannahy, Laura; Hayward, Mark

    2016-08-01

    Group Person-Based Cognitive Therapy (PBCT) integrates cognitive therapy and mindfulness to target distinct sources of distress in psychosis. The present study presents data from the first randomised controlled trial investigating group PBCT in people distressed by hearing voices. One-hundred and eight participants were randomised to receive either group PBCT and Treatment As Usual (TAU) or TAU only. While there was no significant effect on the primary outcome, a measure of general psychological distress, results showed significant between-group post-intervention benefits in voice-related distress, perceived controllability of voices and recovery. Participants in the PBCT group reported significantly lower post-treatment levels of depression, with this effect maintained at six-month follow-up. Findings suggest PBCT delivered over 12weeks effectively impacts key dimensions of the voice hearing experience, supports meaningful behaviour change, and has lasting effects on mood. PMID:27146475

  10. A randomised primal-dual algorithm for distributed radio-interferometric imaging

    CERN Document Server

    Onose, Alexandru; McEwen, Jason D; Wiaux, Yves

    2016-01-01

    Next generation radio telescopes, like the Square Kilometre Array, will acquire an unprecedented amount of data for radio astronomy. The development of fast, parallelisable or distributed algorithms for handling such large-scale data sets is of prime importance. Motivated by this, we investigate herein a convex optimisation algorithmic structure, based on primal-dual forward-backward iterations, for solving the radio interferometric imaging problem. It can encompass any convex prior of interest. It allows for the distributed processing of the measured data and introduces further flexibility by employing a probabilistic approach for the selection of the data blocks used at a given iteration. We study the reconstruction performance with respect to the data distribution and we propose the use of nonuniform probabilities for the randomised updates. Our simulations show the feasibility of the randomisation given a limited computing infrastructure as well as important computational advantages when compared to state...

  11. The post hoc use of randomised controlled trials to explore drug associated cancer outcomes

    DEFF Research Database (Denmark)

    Stefansdottir, Gudrun; Zoungas, Sophia; Chalmers, John;

    2013-01-01

    on public health before proper regulatory action can be taken. This paper aims to discuss challenges of exploring drug-associated cancer outcomes by post-hoc analyses of Randomised controlled trials (RCTs) designed for other purposes. METHODOLOGICAL CHALLENGES TO CONSIDER: We set out to perform a post......INTRODUCTION: Drug-induced cancer risk is of increasing interest. Both observational studies and data from clinical trials have linked several widely used treatments to cancer. When a signal for a potential drug-cancer association is generated, substantiation is required to assess the impact...... challenges must be addressed to enhance the likelihood of reliable conclusions. Advantages of post-hoc analyses of RCTs include quality of data collected and sometimes randomisation to exposure of interest. Limitations include confounding and sample size, which is fixed to suit the purposes of the trial...

  12. Virtual outreach: a randomised controlled trial and economic evaluation of joint teleconferenced medical consultations

    OpenAIRE

    Wallace, P.; Barber, J; Clayton, W.; Currell, R.; Fleming, K.; Garner, P.; Haines, A.; Harrison, R; Jacklin, P.; Jarrett, C.; Jayasuriya, R.; Lewis, L; Parker, S; Roberts, J.; Thompson, S

    2004-01-01

    Objectives: To test the hypotheses that virtual outreach would reduce offers of hospital follow-up appointments and reduce numbers of medical interventions and investigations, reduce numbers of contacts with the health care system, have a positive impact on patient satisfaction and enablement, and lead to improvements in patient health status. To perform an economic evaluation of virtual outreach.Design: A randomised controlled trial comparing joint teleconsultations between GPs, specialists ...

  13. 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;...

  14. Systematic review of randomised controlled trials of sildenafil (Viagra) in the treatment of male erectile dysfunction.

    OpenAIRE

    Burls, A.; Gold, L; Clark, W.

    2001-01-01

    BACKGROUND: Sildenafil (Viagra), a new oral drug for the treatment of erectile dysfunction, was licensed for use across Europe in 1998. AIM: To examine the effectiveness and safety of sildenafil as an oral treatment for erectile dysfunction. DESIGN OF STUDY: Systematic review and meta-analysis. SETTING: All published or unpublished randomised controlled trials comparing sildenafil with a placebo or alternative therapies. METHOD: Published studies were sought by computerised searches of electr...

  15. Tiotropium in patients with moderate COPD naive to maintenance therapy: a randomised placebo-controlled trial

    OpenAIRE

    Troosters, Thierry; Sciurba, Frank C.; Decramer, Marc; Siafakas, Nikos M.; Klioze, Solomon S.; Sutradhar, Santosh C.; Weisman, Idelle M; Yunis, Carla

    2014-01-01

    Background: The benefits of pharmacotherapy with tiotropium HandiHaler 18 μg for patients with chronic obstructive pulmonary disease (COPD) have been previously demonstrated. However, few data exist regarding the treatment of moderate disease (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II). Aims: To determine whether tiotropium improves lung function/patient-reported outcomes in patients with GOLD stage II COPD naive to maintenance therapy. Methods: A randomised 24-we...

  16. 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...

  17. A randomised controlled trial linking mental health inpatients to community smoking cessation supports: A study protocol

    Directory of Open Access Journals (Sweden)

    Clancy Richard

    2011-07-01

    Full Text Available Abstract Background Mental health inpatients smoke at higher rates than the general population and are disproportionately affected by tobacco dependence. Despite the advent of smoke free policies within mental health hospitals, limited systems are in place to support a cessation attempt post hospitalisation, and international evidence suggests that most smokers return to pre-admission smoking levels following discharge. This protocol describes a randomised controlled trial that will test the feasibility, acceptability and efficacy of linking inpatient smoking care with ongoing community cessation support for smokers with a mental illness. Methods/Design This study will be conducted as a randomised controlled trial. 200 smokers with an acute mental illness will be recruited from a large inpatient mental health facility. Participants will complete a baseline survey and will be randomised to either a multimodal smoking cessation intervention or provided with hospital smoking care only. Randomisation will be stratified by diagnosis (psychotic, non-psychotic. Intervention participants will be provided with a brief motivational interview in the inpatient setting and options of ongoing smoking cessation support post discharge: nicotine replacement therapy (NRT; referral to Quitline; smoking cessation groups; and fortnightly telephone support. Outcome data, including cigarettes smoked per day, quit attempts, and self-reported 7-day point prevalence abstinence (validated by exhaled carbon monoxide, will be collected via blind interview at one week, two months, four months and six months post discharge. Process information will also be collected, including the use of cessation supports and cost of the intervention. Discussion This study will provide comprehensive data on the potential of an integrated, multimodal smoking cessation intervention for persons with an acute mental illness, linking inpatient with community cessation support. Trial Registration

  18. Dry needling and exercise for chronic whiplash - a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Souvlis Tina

    2009-12-01

    Full Text Available Abstract Background Chronic whiplash is a common and costly problem. Sensory hypersensitivity is a feature of chronic whiplash that is associated with poor responsiveness to physical treatments such as exercise. Modalities such as dry-needling have shown some capacity to modulate sensory hypersensitivity, suggesting that when combined with advice and exercise, such an approach may be more effective in the management of chronic whiplash. The primary aim of this project is to investigate the effectiveness of dry-needling, advice and exercise for chronic whiplash. Method/Design A double-blind randomised controlled trial will be conducted. 120 participants with chronic whiplash, grade II will be randomised to receive either 1 dry-needling, advice and exercise or 2 sham dry-needling, advice and exercise. All participants will receive an educational booklet on whiplash. Participants who are randomised to Group 1 will receive 6 treatments of combined dry-needling and exercise delivered in the first 3 weeks of the 6 week program, and 4 treatments of exercise only in the last 3 weeks of the program. Participants randomised to Group 2 will receive an identical protocol, except that a sham dry-needling technique will be used instead of dry-needling. The primary outcome measures are the Neck Disability Index (NDI and participants' perceived recovery. Outcomes will be measured at 6, 12, 24 and 52 weeks after randomization by an assessor who is blind to the group allocation of the participants. In parallel, an economic analysis will be conducted. Discussion This trial will utilise high quality trial methodologies in accordance with CONSORT guidelines. The successful completion of this trial will provide evidence of the effectiveness and cost-effectiveness of a combined treatment approach for the management of chronic whiplash. Trial registration ACTRN12609000470291

  19. Randomised clinical trials on acupuncture in the Korean literature: bibliometric analysis and methodological quality

    OpenAIRE

    Kim, Sina; Sagong, Hye Seon; Kong, Jae Cheol; Choi, Jun-Yong; Lee, Myeong Soo; Wieland, L Susan; Manheimer, Eric; Shin, Byung-Cheul

    2013-01-01

    Objective Acupuncture systematic reviewers have increasingly searched Chinese databases and journals to identify eligible randomised clinical trials (RCTs). However, reviewers have infrequently searched for eligible RCTs in Korean databases and journals. This study aimed to identify difficult to locate acupuncture RCTs in Korean databases and journals and to assess the characteristics and quality of the identified RCTs. Methods Eleven electronic databases and seven journals were searched up t...

  20. Effectiveness of training health professionals to provide smoking cessation interventions: systematic review of randomised controlled trials.

    OpenAIRE

    Silagy, C; Lancaster, T.; Gray, S.; Fowler, G

    1994-01-01

    OBJECTIVE--To assess the effectiveness of interventions that train healthcare professionals in methods for improving the quality of care delivered to patients who smoke. DESIGN--Systematic literature review. SETTING--Primary care medical and dental practices in the United States and Canada. Patients were recruited opportunistically. SUBJECTS--878 healthcare professionals and 11,228 patients who smoked and were identified in eight randomised controlled trials. In each of these trials healthcar...

  1. A Randomised Controlled Trial of an Energy Efficiency Intervention for Families Living in Fuel Poverty

    OpenAIRE

    Heyman, Bob; Harrington, Barbara E.; Heyman, Anna

    2011-01-01

    This paper discusses a pragmatic randomised controlled trial of a fuel poverty intervention undertaken in NE England over a four-year period, starting in 2000/2001. Home energy efficiency was measured through Standardised Assessment Procedure (SAP) ratings in each year of the trial. The trial group received an energy efficiency intervention package in year three, and the control group in year four. Year three room temperature data for a sub-sample of 100 households were obtained. A comparison...

  2. Participant recruitment into a randomised controlled trial of exercise therapy for people with multiple sclerosis

    OpenAIRE

    Carter, Anouska; Humphreys, Liam; Snowdon, Nicky; Sharrack, Basil; Daley, Amanda; Petty, Jane; Woodroofe, Nicola; Saxton, John

    2015-01-01

    Background The success of a clinical trial is often dependant on whether recruitment targets can be met in the required time frame. Despite an increase in research into the benefits of exercise in people with multiple sclerosis (PwMS), no trial has reported detailed data on effective recruitment strategies for large-scale randomised controlled trials. The main purpose of this report is to provide a detailed outline of recruitment strategies, rates and estimated costs in the Exercise Intervent...

  3. Randomised controlled trial of effects of coordinating care for terminally ill cancer patients.

    OpenAIRE

    Addington-Hall, J M; MacDonald, L D; Anderson, H R; Chamberlain, J.; Freeling, P.; Bland, J. M.; Raftery, J

    1992-01-01

    OBJECTIVES--To measure effects on terminally ill cancer patients and their families of coordinating the services available within the NHS and from local authorities and the voluntary sector. DESIGN--Randomised controlled trial. SETTING--Inner London health district. PATIENTS--Cancer patients were routinely notified from 1987 to 1990. 554 patients expected to survive less than one year entered the trial and were randomly allocated to a coordination or a control group. INTERVENTION--All patient...

  4. Acupressure at acupoint P6 for prevention of postoperative nausea and vomiting: a randomised clinical trial

    DEFF Research Database (Denmark)

    Majholm, Birgitte; Møller, Ann M

    2011-01-01

    Postoperative nausea and vomiting causes discomfort in many patients despite both antiemetic prophylactics and improved anaesthetic techniques. Stimulation of acupoint P6 is described as an alternative method for prophylaxis of postoperative nausea and vomiting.In a randomised, double-blinded study......, we aimed to investigate the effect of P6 acupoint stimulation on the incidence of postoperative nausea and vomiting within 24 h postoperatively with an acupressure wristband: Vital-Band....

  5. Buprenorphine versus dihydrocodeine for opiate detoxification in primary care: a randomised controlled trial

    OpenAIRE

    Adams Clive E; Tompkins Charlotte NE; Sheard Laura; Wright Nat MJ; Allgar Victoria L; Oldham Nicola S

    2007-01-01

    Abstract Background Many drug users present to primary care requesting detoxification from illicit opiates. There are a number of detoxification agents but no recommended drug of choice. The purpose of this study is to compare buprenorphine with dihydrocodeine for detoxification from illicit opiates in primary care. Methods Open label randomised controlled trial in NHS Primary Care (General Practices), Leeds, UK. Sixty consenting adults using illicit opiates received either daily sublingual b...

  6. Dipyridamole is superior to dobutamine for thallium stress imaging: a randomised crossover study.

    OpenAIRE

    Kumar, E. B.; Steel, S A; Howey, S; Caplin, J L; Aber, C P

    1994-01-01

    OBJECTIVE--To assess the value of dobutamine over dipyridamole as a pharmacological stressing agent in myocardial perfusion imaging with thallium-201. DESIGN--Stress and redistribution tomographic images were taken in a group of patients in a randomised crossover study of both agents. The scans were scored to give a value for the stress and redistribution images and a reversibility score (redistribution--stress). All patients had coronary angiography that was also scored. Differences between ...

  7. Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial

    OpenAIRE

    Freeman, Liv M; Bloemenkamp, Kitty W; Franssen, Maureen T; Papatsonis, Dimitri N; Hajenius, Petra J.; Hollmann, Markus W.; Woiski, Mallory D; Porath, Martina; Berg, Hans J. van den; van Beek, Erik; Borchert, Odette W H M; Schuitemaker, Nico; Sikkema, J Marko; Kuipers, A.H.M.; Logtenberg, Sabine L M

    2015-01-01

    OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an intermediate to high obstetric risk with an intention to deliver vaginally. To exclude a clinically relevant difference in satisfaction with pain relief of more than 10%, we needed to include 1136 women....

  8. Efficacy of cognitive behaviour therapy versus anxiety management for body dysmorphic disorder: a randomised controlled trial

    OpenAIRE

    Veale, D; Anson, M; Miles, S; Pieta, M.; Costa, A.; Ellison, N.

    2014-01-01

    Background: The evidence base for the efficacy of cognitive behaviour therapy (CBT) for treating body dysmorphic disorder (BDD) is weak. Aims: To determine whether CBT is more effective than anxiety management (AM) in an outpatient setting. Method: This was a single-blind stratified parallelgroup randomised controlled trial. The primary endpoint was at 12 weeks, and the Yale-Brown Obsessive Compulsive Scale for BDD (BDD-YBOCS) was the primary outcome measure. Secondary measures for BDD includ...

  9. 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...

  10. Prevention of respiratory complications after abdominal surgery: a randomised clinical trial.

    OpenAIRE

    Hall, J. C.; Tarala, R. A.; Tapper, J.; Hall, J L

    1996-01-01

    OBJECTIVE--To evaluate the prevention of respiratory complications after abdominal surgery by a comparison of a global policy of incentive spirometry with a regimen consisting of deep breathing exercises for low risk patients and incentive spirometry plus physiotherapy for high risk patients. DESIGN--Stratified randomised trial. SETTING--General surgical service of an urban teaching hospital. PATIENTS--456 patients undergoing abdominal surgery. Patients less than 60 years of age with an Ameri...

  11. The effect of the synthetic retinoid etretinate on sputum cytology: results from a randomised trial.

    OpenAIRE

    Arnold, A.M.; Browman, G.P.; Levine, M. N.; D'Souza, T.; Johnstone, B.; Skingley, P.; Turner-Smith, L.; Cayco, R.; Booker, L.; Newhouse, M

    1992-01-01

    Laboratory studies, and one previous uncontrolled trial, have suggested that retinoids may reverse bronchial atypia, a putatively premalignant condition. Sputum sampling is a simple, non-invasive method of assessing atypia. Smokers with at least a 15 pack-year history were screened for sputum atypia. One hundred and fifty subjects' were randomised to receive the synthetic retinoid etretinate 25 mg orally or identical placebo daily for 6 months. Compliance was measured by performing pill count...

  12. The use of glucosamine for chronic low back pain: a systematic review of randomised control trials

    OpenAIRE

    Sodha, Reena; Sivanadarajah, Naveethan; Alam, Mahbub

    2013-01-01

    Objectives To ascertain whether the use of oral glucosamine influences symptoms or functional outcomes in patients with chronic low back pain (LBP) thought to be related to spinal osteoarthritis (OA). Design Systematic review of randomised control trials. Searches were performed up to March 2011 on Medline, AMED, CINHAL, Cochrane and EMBASE with subsequent reference screening of retrieved studies. In addition, the grey literature was searched via opensigle. Included studies were required to i...

  13. The gait and balance of patients with diabetes can be improved: a randomised controlled trial

    OpenAIRE

    Allet, L.; Armand, S.; de Bie, R.A.; Golay, A.; Monnin, D.; Aminian, K.; Staal, J.B.; de Bruin, E. D.

    2009-01-01

    Aims/hypothesis Gait characteristics and balance are altered in diabetic patients. Little is known about possible treatment strategies. This study evaluates the effect of a specific training programme on gait and balance of diabetic patients. Methods This was a randomised controlled trial (n = 71) with an intervention (n = 35) and control group (n = 36). The intervention consisted of physiotherapeutic group training including gait and balance exercises with function-orientated strengthening (...

  14. Multidisciplinary rehabilitation for people with Parkinson's disease: a randomised controlled study

    OpenAIRE

    Wade, D T; Gage, Heather; Owen, C.; Trend, P; Grossmith, C.; Kaye, J

    2003-01-01

    Objective: To determine whether a programme of multidisciplinary rehabilitation and group support achieves sustained benefit for people with Parkinson’s disease or their carers. Methods: The study was a randomised controlled crossover trial comparing patients and carers who had received rehabilitation four months before assessment with those who had not. Patients were recruited from a neurology clinic, attended a day hospital from home weekly for six weeks using private car...

  15. Randomised comparison of ondansetron and metoclopramide plus dexamethasone for chemotherapy induced emesis.

    OpenAIRE

    Dick, G S; Meller, S T; Pinkerton, C R

    1995-01-01

    The serotonin (5HT3) antagonist ondansetron was compared in a randomised study with metoclopramide and dexamethasone for the prevention of chemotherapy induced emesis. Thirty children aged 1-15 years with acute lymphoblastic leukaemia received 'intensification modules' according to the MRC United Kingdom acute lymphoblastic leukaemia regimen UKALL XI. This contains the moderately emetogenic drugs daunorubicin, etoposide, and cytarabine. Fifteen children received an intravenous loading dose of...

  16. Weight-loss intervention using implementation intentions and mental imagery: a randomised control trial study protocol

    OpenAIRE

    Hattar, Anne; Hagger, Martin S.; Pal, Sebely

    2015-01-01

    Background Overweight and obesity are major health problems worldwide. This protocol describes the HEALTHI (Healthy Eating and Active LifesTyle Health Intervention) Program, a 12-week randomised-controlled weight-loss intervention that adopts two theory-based intervention techniques, mental imagery and implementation intentions, a behaviour-change technique based on planning that have been shown to be effective in promoting health-behaviour change in previous research. The effectiveness of go...

  17. Written emotional disclosure for women with ovarian cancer and their partners: randomised controlled trial

    OpenAIRE

    Arden-Close, Emily; Gidron, Yori; Bayne, Louise; Moss-Morris, Rona

    2013-01-01

    Objective: written emotional disclosure for 15–20?min a day over 3 to 4?days improves physical and psychological health and may benefit cancer patients. However, no studies have tested the effectiveness of guided writing in cancer patients and their partners. A randomised controlled trial tested whether writing about the patient's diagnosis and treatment of ovarian cancer using the Guided Disclosure Protocol (GDP) is effective in reducing perceived stress and improving quality of life (QoL) i...

  18. Lessons from a randomised experiment with mixed-mode designs for a household panel survey

    OpenAIRE

    Lynn, Peter; Uhrig, S.C. Noah; Burton, Jonathan

    2010-01-01

    This article describes a randomised experiment with mixed-mode survey designs in the context of a household panel survey. The experiment was designed to allow comparisons between two alternative mixed-mode designs (telephone interviewing plus face-to-face interviewing) and a unimode design (face-to-face interviewing only) in terms of response rates, sample composition, costs and other key outcomes, as well as to permit assessment of the feasibility of implementing the mixed-mode designs.

  19. Clozapine versus placebo in Huntington's disease: a double blind randomised comparative study

    OpenAIRE

    Vugt, J.P.P. van; Siesling, S.; Vergeer, M; van der Velde, E A; R. Roos

    1997-01-01

    OBJECTIVES—To establish the effect of the atypical neuroleptic clozapine on chorea, voluntary motor performance, and functional disability in patients with Huntington's disease.
METHODS—Thirty three patients with Huntington's disease participated in a double blind randomised trial. A maximum of 150 mg/day clozapine or placebo equivalent was given for a period of 31 days. Assessments were performed in the week before and at the last day of the trial. Chorea was scored usin...

  20. Randomised controlled trial of topical kanuka honey for the treatment of acne

    OpenAIRE

    Semprini, Alex; Braithwaite, Irene; Corin, Andrew; Sheahan, Davitt; Tofield, Christopher; Helm, Colin; Montgomery, Barney; Fingleton, James; Weatherall, Mark; Beasley, Richard

    2016-01-01

    Objective To investigate the efficacy of Honevo, a topical 90% medical-grade kanuka honey, and 10% glycerine (honey product) as a treatment for facial acne. Design Randomised controlled trial with single blind assessment of primary outcome variable. Setting Outpatient primary care from 3 New Zealand localities. Participants Of 136 participants aged between 16 and 40 years with a diagnosis of acne and baseline Investigator's Global Assessment (IGA) for acne score of ≥2.68, participants were ra...

  1. Neckties and Cerebrovascular Reactivity in Young Healthy Males: A Pilot Randomised Crossover Trial

    OpenAIRE

    Mark Rafferty; Quinn, Terence J.; Jesse Dawson; Matthew Walters

    2010-01-01

    Background. A necktie may elevate intracranial pressure through compression of venous return. We hypothesised that a tight necktie would deleteriously alter cerebrovascular reactivity. Materials and Methods. A necktie was simulated using bespoke apparatus comprising pneumatic inner-tube with aneroid pressure-gauge. Using a randomised crossover design, cerebrovascular reactivity was measured with the “pseudo-tie” worn inflated or deflated for 5 minutes (simulating tight/loose necktie resp.)....

  2. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework

    OpenAIRE

    Eldridge, Sandra M.; Lancaster, Gillian A.; Michael J. Campbell; Thabane, Lehana; Hopewell, Sally; Coleman, Claire L.; Bond, Christine M

    2016-01-01

    We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of ...

  3. 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...

  4. Acupuncture for treating alopecia areata: a protocol of systematic review of randomised clinical trials

    OpenAIRE

    Lee, Hye Won; Jun, Ji Hee; Lee, Ju Ah; Lim, Hyun-Ja; Lim, Hyun-Suk; Lee, Myeong Soo

    2015-01-01

    Introduction Acupuncture is frequently used in dermatology for treating a number of skin disorders. There is no critically appraised evidence of the potential benefits and harm of acupuncture for alopecia areata (AA). This review aims to systematically evaluate the efficacy of acupuncture for the management of AA in randomised clinical trials (RCTs). Methods and analysis 13 databases will be searched from their inception. These include PubMed, AMED, EMBASE, the Cochrane Library, 6 Korean medi...

  5. CONSORT recommendations in abstracts of randomised, controlled trials on migraine and headache

    DEFF Research Database (Denmark)

    Tfelt-Hansen, Peer Carsten

    2011-01-01

    A CONSORT statement on the content of abstracts of randomised, controlled trials (RCTs) was published in 2008. I therefore reviewed the abstracts from 2009 to 2010 published on RCTs in Cephalalgia, Headache and other (non-headache) journals. The following items were reviewed: number of patients, ....... The influence of the CONSORT statement on reporting in abstracts has so far only had a limited influence on the headache literature....

  6. Effect of unsupervised home based proprioceptive training on recurrences of ankle sprain: randomised controlled trial

    OpenAIRE

    Hupperets, Maarten D W; Verhagen, Evert A L M; van Mechelen, Willem

    2009-01-01

    Objective To evaluate the effectiveness of an unsupervised proprioceptive training programme on recurrences of ankle sprain after usual care in athletes who had sustained an acute sports related injury to the lateral ankle ligament. Design Randomised controlled trial, with one year follow-up. Setting Primary care. Participants 522 athletes, aged 12-70, who had sustained a lateral ankle sprain up to two months before inclusion; 256 (120 female and 136 male) in the intervention group; 266 (128 ...

  7. Supervised exercises for adults with acute lateral ankle sprain: a randomised controlled trial

    OpenAIRE

    Rijn, Rogier; Os, Anton; Kleinrensink, Gert Jan; Bernsen, Roos; Verhaar, JAN; Koes, Bart; Bierma-zeinstra, Sita

    2007-01-01

    textabstractBACKGROUND: During the recovery period after acute ankle sprain, it is unclear whether conventional treatment should be supported by supervised exercise. AIM: To evaluate the short- and long-term effectiveness of conventional treatment combined with supervised exercises compared with conventional treatment alone in patients with an acute ankle sprain. DESIGN: Randomised controlled clinical trial. SETTING: A total of 32 Dutch general practices and the hospital emergency department....

  8. Cognitive–behavioural therapy v. structured care for medically unexplained symptoms: randomised controlled trial

    OpenAIRE

    Sumathipala, A.; Siribaddana, S.; Abeysingha, M. R. N.; Silva, P.; Dewey, M; Prince, M.; Mann, A.H.

    2008-01-01

    Background A pilot trial in Sri Lanka among patients with medically unexplained symptoms revealed that cognitive–behavioural therapy (CBT) administered by a psychiatrist was efficacious. Aims To evaluate CBT provided by primary care physicians in a comparison with structured care. Method A randomised control trial (n=75 in each arm) offered six 30 min sessions of structured care or therapy. The outcomes of the two interventions were compared at 3 months, 6 months, 9 months and 12 months. Resu...

  9. Economic evaluation alongside pragmatic randomised trials: developing a standard operating procedure for clinical trials units

    OpenAIRE

    Russell Ian T; Linck Pat; Hounsome Barry; Edwards Rhiannon T

    2008-01-01

    Abstract Background There is wide recognition that pragmatic randomised trials are the best vehicle for economic evaluation. This is because trials provide the best chance of ensuring internal validity, not least through the rigorous prospective collection of patient-specific data. Furthermore the marginal cost of collecting economic data alongside clinical data is typically modest. UK Clinical Research Collaboration (UKCRC) does not require a standard operating procedure (SOP) for economic e...

  10. Randomised trial of endoscopic endoprosthesis versus operative bypass in malignant obstructive jaundice

    DEFF Research Database (Denmark)

    Andersen, J R; Sørensen, S M; Kruse, A;

    1989-01-01

    In patients with obstructive jaundice caused by malignant stricture of the extrahepatic bile duct we compared survival time, complication rates, hospitalisation requirements, and quality of life after palliation by endoscopic endoprosthesis or bypass surgery. During diagnostic endoscopic...... survival between treatment groups or randomisation groups. No differences were found when other variables were compared. We conclude, that palliation of obstructive jaundice in malignant bile duct obstruction with endoscopically introduced endoprosthesis is as effective as operative bypass....

  11. Somatostatin in the treatment of acute pancreatitis: A prospective randomised controlled trial

    OpenAIRE

    Choi, T. K.; Mok, F; Zhan, W H; Fan, S. T.; Lai, E C; Wong, J

    1989-01-01

    A prospective study was carried out to evaluate the efficacy of somatostatin in the treatment of acute pancreatitis. Seventy one patients were randomised to control (h = 36), or to the somatostatin group (h = 35) who received somatostatin 100 micrograms/h after a 250 microgram bolus for the first two days. The following were compared in the two groups on admission and two days later: laboratory tests of prognostic significance, severity of pancreatitis, and also morbidity and mortality. Of th...

  12. Psychodynamic guided self-help for adult depression through the internet: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Robert Johansson

    Full Text Available BACKGROUND AND AIMS: Psychodynamic psychotherapy (PDT is an effective treatment for major depressive disorder (MDD, but not all clients with MDD can receive psychotherapy. Using the Internet to provide psychodynamic treatments is one way of improving access to psychological treatments for MDD. The aim of this randomised controlled trial was to investigate the efficacy of an Internet-based psychodynamic guided self-help treatment for MDD. METHODS: Ninety-two participants who were diagnosed with MDD according to the Mini-International Neuropsychiatric Interview were randomised to treatment or an active control. The treatment consisted of nine treatment modules based on psychodynamic principles with online therapist contact. The active control condition was a structured support intervention and contained psychoeducation and scheduled weekly contacts online. Both interventions lasted for 10 weeks. The primary outcome measure was the Beck Depression Inventory-II (BDI-II. RESULTS: Mixed-effects model analyses of all randomised participants showed that participants receiving Internet-based PDT made large and superior improvements compared with the active control group on the BDI-II (between-group Cohen's d = 1.11. Treatment effects were maintained at a 10-month follow-up. CONCLUSIONS: Internet-based psychodynamic guided self-help is an efficacious treatment for MDD that has the potential to increase accessibility and availability of PDT for MDD. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01324050.

  13. Assessing the Causality between Blood Pressure and Retinal Vascular Caliber through Mendelian Randomisation

    Science.gov (United States)

    Li, Ling-Jun; Liao, Jiemin; Cheung, Carol Yim-Lui; Ikram, M. Kamran; Shyong, Tai E.; Wong, Tien-Yin; Cheng, Ching-Yu

    2016-02-01

    We aimed to determine the association between blood pressure (BP) and retinal vascular caliber changes that were free from confounders and reverse causation by using Mendelian randomisation. A total of 6528 participants from a multi-ethnic cohort (Chinese, Malays, and Indians) in Singapore were included in this study. Retinal arteriolar and venular caliber was measured by a semi-automated computer program. Genotyping was done using Illumina 610-quad chips. Meta-analysis of association between BP, and retinal arteriolar and venular caliber across three ethnic groups was performed both in conventional linear regression and Mendelian randomisation framework with a genetic risk score of BP as an instrumental variable. In multiple linear regression models, each 10 mm Hg increase in systolic BP, diastolic BP, and mean arterial BP (MAP) was associated with significant decreases in retinal arteriolar caliber of a 1.4, 3.0, and 2.6 μm, and significant decreases in retinal venular caliber of a 0.6, 0.7, and 0.9 μm, respectively. In a Mendelian randomisation model, only associations between DBP and MAP and retinal arteriolar narrowing remained yet its significance was greatly reduced. Our data showed weak evidence of a causal relationship between elevated BP and retinal arteriolar narrowing.

  14. 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

  15. The Women's international study of long-duration oestrogen after menopause (WISDOM: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Meade Tom W

    2007-02-01

    Full Text Available Abstract Background At the time of feasibility work and final design of the trial there was no randomised control trial evidence for the long-term risks and benefits of hormone replacement therapy. Observational studies had suggested that long term use of estrogen was likely to be associated, amongst other things, with reduced risks of osteoporosis and ischaemic heart disease and increased risks of breast and endometrial cancer. Concomitant use of progestogens had been shown to protect against endometrial cancer, but there were few data showing how progestogen might affect estrogen actions on other conditions. Disease specific risks from observational studies suggested that, overall, long-term HRT was likely to be beneficial. Several studies showed that mortality from all causes was lower in HRT users than in non-users. Some secondary cardiovascular prevention trials were ongoing but evidence was also required for a range of outcomes in healthy women. The WISDOM trial was designed to compare combined estrogen and progestogen versus placebo, and estrogen alone versus combined estrogen and progestogen. During the development of WISDOM the Women's Health Initiative trial was designed, funded and started in the US. Design Randomised, placebo, controlled, trial. Methods The trial was set in general practices in the UK (384, Australia (94, and New Zealand (24. In these practices 284175 women aged 50–69 years were registered with 226282 potentially eligible. We sought to randomise 22300 postmenopausal women aged 50 – 69 and treat for ten years. The interventions were: conjugated equine estrogens, 0.625 mg orally daily; conjugated equine estrogens plus medroxyprogesterone acetate 2.5/5.0 mg orally daily; matched placebo. Primary outcome measures were: major cardiovascular disease, osteoporotic fractures, breast cancer and dementia. Secondary outcomes were: other cancers, all cause death, venous thromboembolism and cerebro-vascular disease. Results

  16. 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

  17. Clinical score and rapid antigen detection test to guide antibiotic use for sore throats: randomised controlled trial of PRISM (primary care streptococcal management)

    OpenAIRE

    P. Little; Hobbs, F D R; Moore, M.; Mant, D; Williamson, I.; McNulty, C; Cheng, Y.E.; Leydon, G; McManus, R; Kelly, J; Barnett, J; Glasziou, P.; Mullee, M

    2013-01-01

    OBJECTIVE: To determine the effect of clinical scores that predict streptococcal infection or rapid streptococcal antigen detection tests compared with delayed antibiotic prescribing. DESIGN: Open adaptive pragmatic parallel group randomised controlled trial. SETTING: Primary care in United Kingdom. PATIENTS: Patients aged ?3 with acute sore throat. INTERVENTION: An internet programme randomised patients to targeted antibiotic use according to: delayed antibiotics (the compara...

  18. Percutaneous vertebroplasty compared to conservative treatment in patients with painful acute or subacute osteoporotic vertebral fractures.Three months follow up in a clinical randomised study

    DEFF Research Database (Denmark)

    Rousing, Rikke

    2008-01-01

    Abstract Study design. Clinical randomised study.    Objective. The aim of this study is to compare PVP to conservative treatment of patients with osteoporotic vertebral fractures in a clinical randomised study with respect to pain, physical and mental outcome, and to asses the risk of adjacent f...

  19. 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

  20. Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST: study protocol for a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    McColl Elaine

    2011-06-01

    Full Text Available Abstract Background High blood pressure during acute stroke is associated with poorer stroke outcome. Previous trials have failed to show benefit from lowering blood pressure but treatment may have been commenced too late to be effective. The earliest that acute stroke treatments could be initiated is during contact with the emergency medical services (paramedics. However, experience of pre-hospital clinical trials is limited and logistical challenges are likely to be greater than for trials performed in other settings. We report the protocol for a pilot randomised controlled trial of paramedic initiated blood pressure lowering treatment for hypertension in acute stroke. Methods Trial Design: Double blind parallel group external pilot randomised controlled trial. Setting: Participant recruitment and initial treatment by North East Ambulance Service research trained paramedics responding to the emergency call. Continued treatment in three study hospitals. Participants: Target is recruitment of 60 adults with acute arm weakness due to suspected stroke (within 3 hours of symptom onset and hypertension (systolic BP>160 mmHg. Intervention: Lisinopril 5-10 mg (intervention group, matched placebo (control group, daily for 7 days. Randomisation: Study medication contained within identical pre-randomised "trial packs" carried by research trained paramedics. Outcomes: Study feasibility (recruitment rate, compliance with data collection and clinical data to inform the design of a definitive randomised controlled trial (blood pressure monitoring, National Institute of Health Stroke Scale, Barthel ADL Index, Modified Rankin Scale, renal function. Discussion This pilot study is assessing the feasibility of a randomised controlled trial of paramedic initiated lisinopril for hypertension early after the onset of acute stroke. The results will inform the design of a definitive RCT to evaluate the effects of very early blood pressure lowering in acute stroke

  1. Study protocol for the randomised controlled trial: combined multimarker screening and randomised patient treatment with ASpirin for evidence-based PREeclampsia prevention (ASPRE)

    Science.gov (United States)

    O'Gorman, Neil; Wright, David; Rolnik, Daniel L; Nicolaides, Kypros H; Poon, Liona C

    2016-01-01

    Introduction Pre-eclampsia (PE) affects 2–3% of all pregnancies and is a major cause of maternal and perinatal morbidity and mortality. Prophylactic use of low-dose aspirin in women at risk for PE may substantially reduce the prevalence of the disease. Effective screening for PE requiring delivery before 37 weeks (preterm PE) can be provided by a combination of maternal factors, uterine artery Doppler, mean arterial pressure, maternal serum pregnancy-associated plasma protein A and placental growth factor at 11–13 weeks' gestation, with a detection rate of 75% at a false-positive rate of 10%. We present a protocol (V.6, date 25 January 2016) for the ASpirin for evidence-based PREeclampsia prevention (ASPRE) trial, which is a double-blinded, placebo-controlled, randomised controlled trial (RCT) that uses an effective PE screening programme to determine whether low-dose aspirin given to women from 11 to 13 weeks' gestation will reduce the incidence of preterm PE. Methods and analysis All eligible women attending for their first trimester scan will be invited to participate in the screening study for preterm PE. Those found to be at high risk of developing preterm PE will be invited to participate in the RCT. Further scans will be conducted for assessment of fetal growth and biomarkers. Pregnancy and neonatal outcomes will be collected and analysed. The first enrolment for the pilot study was in April 2014. As of April 2016, 26 670 women have been screened and 1760 recruited to the RCT. The study is registered on the International Standard Randomised Controlled Trial Number (ISRCTN) registry. Trial registration number ISRCTN13633058. PMID:27354081

  2. Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Rosenberg Jacob

    2011-08-01

    Full Text Available Abstract Background Perforated diverticulitis is a condition associated with substantial morbidity. Recently published reports suggest that laparoscopic lavage has fewer complications and shorter hospital stay. So far no randomised study has published any results. Methods DILALA is a Scandinavian, randomised trial, comparing laparoscopic lavage (LL to the traditional Hartmann's Procedure (HP. Primary endpoint is the number of re-operations within 12 months. Secondary endpoints consist of mortality, quality of life (QoL, re-admission, health economy assessment and permanent stoma. Patients are included when surgery is required. A laparoscopy is performed and if Hinchey grade III is diagnosed the patient is included and randomised 1:1, to either LL or HP. Patients undergoing LL receive > 3L of saline intraperitoneally, placement of pelvic drain and continued antibiotics. Follow-up is scheduled 6-12 weeks, 6 months and 12 months. A QoL-form is filled out on discharge, 6- and 12 months. Inclusion is set to 80 patients (40+40. Discussion HP is associated with a high rate of complication. Not only does the primary operation entail complications, but also subsequent surgery is associated with a high morbidity. Thus the combined risk of treatment for the patient is high. The aim of the DILALA trial is to evaluate if laparoscopic lavage is a safe, minimally invasive method for patients with perforated diverticulitis Hinchey grade III, resulting in fewer re-operations, decreased morbidity, mortality, costs and increased quality of life. Trial registration British registry (ISRCTN for clinical trials ISRCTN82208287http://www.controlled-trials.com/ISRCTN82208287

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

    Directory of Open Access Journals (Sweden)

    Swift Louise

    2011-07-01

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

  4. 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.

  5. 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

  6. The Home-Based Older People's Exercise (HOPE trial: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Forster Anne

    2011-06-01

    Full Text Available Abstract Background Frailty is common in older age, and is associated with important adverse health outcomes including increased risk of disability and admission to hospital or long-term care. Exercise interventions for frail older people have the potential to reduce the risk of these adverse outcomes by increasing muscle strength and improving mobility. Methods/Design The Home-Based Older People's Exercise (HOPE trial is a two arm, assessor blind pilot randomised controlled trial (RCT to assess the effectiveness of a 12 week exercise intervention (the HOPE programme designed to improve the mobility and functional abilities of frail older people living at home, compared with usual care. The primary outcome is the timed-up-and-go test (TUGT, measured at baseline and 14 weeks post-randomisation. Secondary outcomes include the Barthel Index of activities of daily living (ADL, EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D quality of life measure and the geriatric depression scale (GDS, measured at baseline and 14 weeks post-randomisation. We will record baseline frailty using the Edmonton Frail Scale (EFS, record falls and document muscle/joint pain. We will test the feasibility of collection of data to identify therapy resources required for delivery of the intervention. Discussion The HOPE trial will explore and evaluate a home-based exercise intervention for frail older people. Although previous RCTs have used operationalised, non-validated methods of measuring frailty, the HOPE trial is, to our knowledge, the first RCT of an exercise intervention for frail older people that includes a validated method of frailty assessment at baseline. Trial registration ISRCTN: ISRCTN57066881

  7. Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2)

    OpenAIRE

    Buttgereit, Frank; Mehta, Daksha; Kirwan, John; Szechinski, Jacek; Boers, Maarten; Alten, Rieke E; Supronik, Jerzy; Szombati, Istvan; Romer, Ulrike; Witte, Stephan; Saag, Kenneth G.

    2012-01-01

    Objective To assess the efficacy and safety of low-dose prednisone chronotherapy using a new modified-release (MR) formulation for the treatment of rheumatoid arthritis (RA). Methods In this 12-week, double-blind, placebo-controlled study, patients with active RA (n=350) were randomised 2:1 to receive MR prednisone 5 mg or placebo once daily in the evening in addition to their existing RA disease-modifying antirheumatic drug (DMARD) treatment. The primary end point was the percentage of patie...

  8. Xylitol chewing gum in prevention of acute otitis media: double blind randomised trial.

    OpenAIRE

    Uhari, M.; Kontiokari, T; Koskela, M.; Niemelä, M. (Mika)

    1996-01-01

    OBJECTIVE: To examine whether xylitol, which reduces the growth of Streptococcus pneumoniae, might have clinical importance in the prevention of acute otitis media. DESIGN: A double blind randomised trial with xylitol administered in chewing gum. SETTING: Eleven day care nurseries in the city of Oulu. Most of the children had had problems with recurrent acute otitis media. SUBJECTS: 306 day care children: 149 children in the sucrose group (76 boys; mean (SD) age 4.9 (1.5) years) and 157 in th...

  9. Children, parents, and pets exercising together (CPET randomised controlled trial: study rationale, design, and methods

    Directory of Open Access Journals (Sweden)

    Yam Philippa S

    2012-03-01

    Full Text Available Abstract Background Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. Methods/design The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry; body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. Discussion The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical

  10. Randomised Clinical Efficacy Trial of Topiramate and Nitrazepam in Treatment of Infantile Spasms

    OpenAIRE

    Razieh FALLAH; SALOR, Fahimah; Sedighah Akhavan Karbasi; Hadi Motaghipisheh

    2014-01-01

    How to Cite This Article: Fallah R, Salor F, Akhavan Karbasi S, Motaghipisheh H. Randomised Clinical Efficacy Trial of Topiramate and Nitrazepam in Treatment of Infantile Spasms. Iran J Child Neurol. 2014 Winter; 8(1):12-19.ObjectiveInfantile spasms (IS) are among the most catastrophic epileptic syndromes of infancy. The purpose of this study was to compare efficacy and safety of topiramate (TPM) and nitrazepam (NZP) as first-line drugs in the treatment ofIS.Materials & MethodsIn a parall...

  11. Randomised comparison of early versus late induction of labour in post-term pregnancy.

    OpenAIRE

    Augensen, K; Bergsjø, P; Eikeland, T; Askvik, K; Carlsen, J.

    1987-01-01

    In a prospective randomised study of mothers referred for prolonged pregnancy (around the 42nd week) 214 (group 1) were submitted to attempted induction of labour and 195 (group 2) assigned to continue for a further week without intervention. Strict selection criteria were used for the certainty of term. Mothers in group 2 were given regular non-stress tests to ensure fetal wellbeing, as were those in group 1 in whom induction failed. In group 1, 48 (23%) out of 210 first attempted inductions...

  12. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials (Chinese version)

    DEFF Research Database (Denmark)

    Moher, David; Hopewell, Sally; Schulz, Kenneth F;

    2010-01-01

    Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate...... that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed...

  13. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials

    DEFF Research Database (Denmark)

    Moher, David; Hopewell, Sally; Schulz, Kenneth F;

    2010-01-01

    Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate...... that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed...

  14. 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...

  15. Post-Operative Benefits of Animal-Assisted Therapy in Pediatric Surgery: A Randomised Study

    OpenAIRE

    Calcaterra, Valeria; Veggiotti, Pierangelo; Palestrini, Clara; De Giorgis, Valentina; Raschetti, Roberto; Tumminelli, Massimiliano; Mencherini, Simonetta; Papotti, Francesca; Klersy, Catherine; Albertini, Riccardo; Ostuni, Selene; Pelizzo, Gloria

    2015-01-01

    Background Interest in animal-assisted therapy has been fuelled by studies supporting the many health benefits. The purpose of this study was to better understand the impact of an animal-assisted therapy program on children response to stress and pain in the immediate post-surgical period. Patients and Methods Forty children (3–17 years) were enrolled in the randomised open-label, controlled, pilot study. Patients were randomly assigned to the animal-assisted therapy-group (n = 20, who underw...

  16. Randomised, controlled study of intratumoral recombinant gamma-interferon treatment in newly diagnosed glioblastoma.

    OpenAIRE

    Färkkilä, M; Jääskeläinen, J.; Kallio, M. (Miki); Blomstedt, G.; Raininko, R; Virkkunen, P.; Paetau, A.; Sarelin, H.; Mäntylä, M

    1994-01-01

    The effect of intratumoral recombinant interferon gamma (rIFN-gamma) as adjuvant to open cytoreduction and external irradiation of 60 Gy on survival in adults with a newly diagnosed high-grade cerebral glioma was studied. The patients were randomised during surgery into the rIFN-gamma group (n = 14) or the control group (n = 17), and the latter received a subcutaneous reservoir of rIFN-gamma injections. Intratumoral rIFN-gamma was given three times a week for 4 weeks until radiotherapy, escal...

  17. Effect of virtual reality training on laparoscopic surgery: randomised controlled trial

    DEFF Research Database (Denmark)

    2009-01-01

    OBJECTIVE: To assess the effect of virtual reality training on an actual laparoscopic operation. DESIGN: Prospective randomised controlled and blinded trial. SETTING: Seven gynaecological departments in the Zeeland region of Denmark. PARTICIPANTS: 24 first and second year registrars specialising...... in gynaecology and obstetrics. INTERVENTIONS: Proficiency based virtual reality simulator training in laparoscopic salpingectomy and standard clinical education (controls). MAIN OUTCOME MEASURE: The main outcome measure was technical performance assessed by two independent observers blinded to trainee......-14 minutes) and in the control group was 24 (20-29) minutes (Pvirtual reality simulator training. The performance level of novices...

  18. Smoking habits in the randomised Danish Lung Cancer Screening Trial with low-dose CT

    DEFF Research Database (Denmark)

    Ashraf, Haseem; Saghir, Zaigham; Dirksen, Asger;

    2014-01-01

    BACKGROUND: We present the final results of the effect of lung cancer screening with low-dose CT on the smoking habits of participants in a 5-year screening trial. METHODS: The Danish Lung Cancer Screening Trial (DLCST) was a 5-year screening trial that enrolled 4104 subjects; 2052 were randomised...... to annual low-dose CT (CT group) and 2052 received no intervention (control group). Participants were current and ex-smokers (≥4 weeks abstinence from smoking) with a tobacco consumption of ≥20 pack years. Smoking habits were determined annually. Missing values for smoking status at the final screening...

  19. Randomised in situ trial on the effect of milk and CPP-ACP on dental erosion

    OpenAIRE

    Wiegand, Annette; Attin, Thomas

    2014-01-01

    OBJECTIVES This randomised in situ study aimed to analyse the effect of milk (with or without 5ppm F) and CPP-ACP pastes (with or without 900ppm F) on dental erosion. METHODS The study was a seven phase (5 days each) crossover design involving 15 participants wearing intraoral appliances with enamel and dentine specimens. Specimens were extraorally eroded (erosive soft drink, 6×90s/day) and brushed (2×30s/day, 2N) using a non-fluoridated toothpaste (negative control). The test products wer...

  20. Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trial

    OpenAIRE

    Salisbury, Chris; O’Cathain, Alicia; Thomas, Clare; Edwards, Louisa; Gaunt, Daisy; Dixon, Padraig; Hollinghurst, Sandra; Nicholl, Jon; Large, Shirley; Yardley, Lucy; Fahey, Tom; Foster, Alexis; Garner, Katy; Horspool, Kimberley; Man, Mei-See

    2016-01-01

    Objective To assess whether non-clinical staff can effectively manage people at high risk of cardiovascular disease using digital health technologies. Design Pragmatic, multicentre, randomised controlled trial. Setting 42 general practices in three areas of England. Participants Between 3 December 2012 and 23 July 2013 we recruited 641 adults aged 40 to 74 years with a 10 year cardiovascular disease risk of 20% or more, no previous cardiovascular event, at least one modifiable risk factor (sy...

  1. Photoageing Intervention ( PAINT: A proposal for a randomised controlled trial in Australian Primary Care

    Directory of Open Access Journals (Sweden)

    Oksana Burford

    2009-07-01

    Full Text Available The adverse health impacts of tobacco smoking are adrain on national resources. This study will test anintervention to promote smoking cessation among youngadults aged 18-30years. The intervention will be deliveredwithin two settings in Australian health care; communitypharmacies and general practice. The new study builds onthe pilot data, reported here, which inform the feasibility,recruitment strategy, outcome measure, effect size andattrition rate. The new study is a randomised controlledtrial with 200 clients recruited from general practice andcommunity pharmacies in Western Australia.

  2. Randomised, double blind trial of two loading dose regimens of diamorphine in ventilated newborn infants.

    OpenAIRE

    Barker, D. P.; Simpson, J.; Pawula, M.; Barrett, D A; Shaw, P N; N. Rutter

    1995-01-01

    AIMS--To compare the safety and efficacy of two loading doses of diamorphine in 27 ventilated newborn infants in a randomised double blind trial. METHODS--Fifty or 200 mcg/kg were infused intravenously over 30 minutes, followed by a 15 mcg/kg/hour continuous infusion. Serial measurements were made of physiology, behaviour, and stress hormones. RESULTS--Both loading doses produced small but significant falls in blood pressure. The 200 mcg/kg dose produced greater respiratory depression, and tw...

  3. 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

  4. Systematic review of randomised controlled trials:Probiotics for functional constipation

    Institute of Scientific and Technical Information of China (English)

    Anna; Chmielewska; Hania; Szajewska

    2010-01-01

    AIM:To systematically evaluate and update evidence on the efficacy and safety of probiotic supplementation for the treatment of constipation. METHODS:The MEDLINE,EMBASE,CINAHL,and Cochrane Library databases were searched in May 2009 for randomised controlled trials(RCTs)performed in paediatric or adult populations related to the study aim. RESULTS:We included five RCTs with a total of 377 subjects(194 in the experimental group and 183 in the control group).The participants were adults (three RCTs,n=266)and ...

  5. Study Protocol: Screening and Treatment of Alcohol-Related Trauma (START – a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Jayaraj Rama

    2012-10-01

    Full Text Available Abstract Background The incidence of mandibular fractures in the Northern Territory of Australia is very high, especially among Indigenous people. Alcohol intoxication is implicated in the majority of facial injuries, and substance use is therefore an important target for secondary prevention. The current study tests the efficacy of a brief therapy, Motivational Care Planning, in improving wellbeing and substance misuse in youth and adults hospitalised with alcohol-related facial trauma. Methods and design The study is a randomised controlled trial with 6 months of follow-up, to examine the effectiveness of a brief and culturally adapted intervention in improving outcomes for trauma patients with at-risk drinking admitted to the Royal Darwin Hospital maxillofacial surgery unit. Potential participants are identified using AUDIT-C questionnaire. Eligible participants are randomised to either Motivational Care Planning (MCP or Treatment as Usual (TAU. The outcome measures will include quantity and frequency of alcohol and other substance use by Timeline Followback. The recruitment target is 154 participants, which with 20% dropout, is hoped to provide 124 people receiving treatment and follow-up. Discussion This project introduces screening and brief interventions for high-risk drinkers admitted to the hospital with facial trauma. It introduces a practical approach to integrating brief interventions in the hospital setting, and has potential to demonstrate significant benefits for at-risk drinkers with facial trauma. Trial Registration The trial has been registered in Australian New Zealand Clinical Trials Registry (ANZCTR and Trial Registration: ACTRN12611000135910.

  6. Visibility aids for pedestrians and cyclists: a systematic review of randomised controlled trials.

    Science.gov (United States)

    Kwan, Irene; Mapstone, James

    2004-05-01

    This study aims to quantify the effect of visibility aids on the occurrence of pedestrian and cyclist-motor vehicle collisions and injuries, and drivers' responses in detection and recognition. Trial reports were systematically reviewed according to predefined eligibility criteria, including randomised controlled trials or controlled before-and-after trials comparing visibility aids and no visibility aids, and of different visibility aids on pedestrian and cyclist safety, and drivers' responses in detection and recognition. This included trials in which the order of interventions was randomised, or balanced using a Latin square design. Two reviewers independently assessed validity of trials and abstracted data. The main outcome measures were pedestrian and cyclist-motor vehicle collisions and injuries, and drivers'/observers' responses in the detection and recognition time, distance and frequency. No trials which assessed the effect of visibility aids on pedestrian and cyclist-motor vehicle collisions and injuries were identified. Twelve trials examined the effectiveness of daytime visibility aids and 25 trials on night time visibility aids, including 882 participants. Drivers' and observers' detection and recognition improved with visibility aids. For daytime, fluorescent materials in yellow, red and orange colours enhanced detection and recognition. "Biomotion" markings enhanced recognition. Substantial heterogeneity between the trials limits the possibility for meta-analysis. Visibility aids have the potential to improve detection and recognition and would merit further development to gain public acceptance. However, the impact of visibility aids on pedestrian and cyclist safety is unknown and needs to be determined. PMID:15003574

  7. Physiological variation of retinal layer thickness is not caused by hydration: a randomised trial.

    Science.gov (United States)

    Balk, Lisanne J; Oberwahrenbrock, Timm; Uitdehaag, Bernard M J; Petzold, Axel

    2014-09-15

    There is evidence for physiological variation of retinal thicknesses as determined by optical coherence tomography (OCT). We tested if such changes could be explained by hydration and would exceed what may be expected from normal ageing. Subjects (n=26) of a previous study were re-assessed and were randomised to 3 groups of a hydration escalation trial (no hydration, 1× hydration, 2× hydration). Automated retinal layer segmentations were performed for the macular retinal nerve fibre layer (RNFL), ganglion cell layer (GCL), inner plexiform layer (IPL), inner nuclear layer (INL), outer plexiform layer (OPL) and outer nuclear layer (ONL). The averaged volumes were calculated for the central foveola, 3 mm and 6 mm circles of the ETDRS grid. Following oral hydration there were no significant differences of retinal layer thicknesses between the three randomised groups in any of the ETDRS regions at any time-point. Ageing related changes were significant over an 18 month period for the GCL. The negative outcome of this trial implies that, until the causes for the observed variation are resolved, investigators may need to accept, and include into trial power calculations, a small degree of variation (<1%) of quantitative SD-OCT imaging either due to human physiology or instrument/software related factors.

  8. Randomised double-blind comparative study of dexmedetomidine and tramadol for post-spinal anaesthesia shivering

    Directory of Open Access Journals (Sweden)

    Geeta Mittal

    2014-01-01

    Full Text Available Background and Aims: Dexmedetomidine (α2 adrenergic agonist has been used for prevention of post anaesthesia shivering. Its use for the treatment of post-spinal anaesthesia shivering has not been evaluated. The aim of this study was to evaluate and compare the efficacy, haemodynamic and adverse effects of dexmedetomidine with those of tramadol, when used for control of post-spinal anaesthesia shivering. Methods: A prospective, randomised, and double-blind study was conducted in 50 American Society of Anaesthesiologists Grade I and II patients of either gender, aged between 18 and 65 years, scheduled for various surgical procedures under spinal anaesthesia. The patients were randomised in two groups of 25 patients each to receive either dexmedetomidine 0.5 μg/kg or tramadol 0.5 mg/kg as a slow intravenous bolus. Grade of shivering, onset of shivering, time for cessation of shivering, recurrence, response rate, and adverse effects were observed at scheduled intervals. Unpaired t-test was used for analysing the data. Results: Time taken for cessation of shivering was significantly less with dexmedetomidine when compared to tramadol. Nausea and vomiting was observed only in tramadol group (28% and; 20% respectively. There was not much difference in the sedation profile of both the drugs. Conclusion: We conclude that although both drugs are effective, the time taken for cessation of shivering is less with dexmedetomidine when compared to tramadol. Moreover, dexmedetomidine has negligible adverse effects, whereas tramadol is associated with significant nausea and vomiting.

  9. Effectiveness of group body psychotherapy for negative symptoms of schizophrenia: multicentre randomised controlled trial†

    Science.gov (United States)

    Priebe, S.; Savill, M.; Wykes, T.; Bentall, R. P.; Reininghaus, U.; Lauber, C.; Bremner, S.; Eldridge, S.; Röhricht, F.

    2016-01-01

    Background Negative symptoms of schizophrenia have a severe impact on functional outcomes and treatment options are limited. Arts therapies are currently recommended but more evidence is required. Aims To assess body psychotherapy as a treatment for negative symptoms compared with an active control (trial registration: ISRCTN84216587). Method Schizophrenia out-patients were randomised into a 20-session body psychotherapy or Pilates group. The primary outcome was negative symptoms at end of treatment. Secondary outcomes included psychopathology, functional, social and treatment satisfaction outcomes at treatment end and 6-months later. Results In total, 275 participants were randomised. The adjusted difference in negative symptoms was 0.03 (95% CI −1.11 to 1.17), indicating no benefit from body psychotherapy. Small improvements in expressive deficits and movement disorder symptoms were detected in favour of body psychotherapy. No other outcomes were significantly different. Conclusions Body psychotherapy does not have a clinically relevant beneficial effect in the treatment of patients with negative symptoms of schizophrenia. PMID:27151073

  10. A randomised trial of nutrient supplements to minimise psychological stress after a natural disaster.

    Science.gov (United States)

    Kaplan, Bonnie J; Rucklidge, Julia J; Romijn, Amy R; Dolph, Michael

    2015-08-30

    After devastating flooding in southern Alberta in June 2013, we attempted to replicate a New Zealand randomised trial that showed that micronutrient (minerals, vitamins) consumption after the earthquakes of 2010-11 resulted in improved mental health. Residents of southern Alberta were invited to participate in a study on the potential benefit of nutrient supplements following a natural disaster. Fifty-six adults aged 23-66 were randomised to receive a single nutrient (vitamin D, n=17), a few-nutrients formula (B-Complex, n=21), or a broad-spectrum mineral/vitamin formula (BSMV, n=18). Self-reported changes in depression, anxiety and stress were monitored for six weeks. Although all groups showed substantial decreases on all measures, those consuming the B-Complex and the BSMV formulas showed significantly greater improvement in stress and anxiety compared with those consuming the single nutrient, with large effect sizes (Cohen's d range 0.76-1.08). There were no group differences between those consuming the B-Complex and BSMV. The use of nutrient formulas with multiple minerals and/or vitamins to minimise stress associated with natural disasters is now supported by three studies. Further research should be carried out to evaluate the potential population benefit that might accrue if such formulas were distributed as a post-disaster public health measure.

  11. Replicability of sight word training and phonics training in poor readers: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    G McArthur

    2015-05-01

    Full Text Available Given the importance of effective treatments for children with reading impairment, paired with growing concern about the lack of scientific replication in psychological science, the aim of this study was to replicate a quasi-randomised trial of sight word and phonics training using a randomised controlled trial (RCT design. One group of poor readers (N = 41 did 8 weeks of phonics training (i.e., phonological decoding and then 8 weeks of sight word training (i.e., whole-word recognition. A second group did the reverse order of training. Sight word and phonics training each had a large and significant valid treatment effect on trained irregular words and word reading fluency. In addition, combined sight word and phonics training had a moderate and significant valid treatment effect on nonword reading accuracy and fluency. These findings demonstrate the reliability of both phonics and sight word training in treating poor readers in an era where the importance of scientific reliability is under close scrutiny.

  12. The effect of 3% and 6% hypertonic saline in viral bronchiolitis: a randomised controlled trial.

    Science.gov (United States)

    Teunissen, Jasmijn; Hochs, Anne H J; Vaessen-Verberne, Anja; Boehmer, Annemie L M; Smeets, Carien C J M; Brackel, Hein; van Gent, René; Wesseling, Judith; Logtens-Stevens, Danielle; de Moor, Ronald; Rosias, Philippe P R; Potgieter, Steph; Faber, Marianne R; Hendriks, Han J E; Janssen-Heijnen, Maryska L G; Loza, Bettina F

    2014-10-01

    Bronchiolitis is a common disorder in young children that often results in hospitalisation. Except for a possible effect of nebulised hypertonic saline (sodium chloride), no evidence-based therapy is available. This study investigated the efficacy of nebulised 3% and 6% hypertonic saline compared with 0.9% hypertonic saline in children hospitalised with viral bronchiolitis. In this multicentre, double-blind, randomised, controlled trial, children hospitalised with acute viral bronchiolitis were randomised to receive either nebulised 3%, 6% hypertonic saline or 0.9% normal saline during their entire hospital stay. Salbutamol was added to counteract possible bronchial constriction. The primary endpoint was the length of hospital stay. Secondary outcomes were need for supplemental oxygen and tube feeding. From the 292 children included in the study (median age 3.4 months), 247 completed the study. The median length of hospital stay did not differ between the groups: 69 h (interquartile range 57), 70 h (IQR 69) and 53 h (IQR 52), for 3% (n=84) and 6% (n=83) hypertonic saline and 0.9% (n=80) normal saline, respectively, (p=0.29). The need for supplemental oxygen or tube feeding did not differ significantly. Adverse effects were similar in the three groups. Nebulisation with hypertonic saline (3% or 6% sodium chloride) although safe, did not reduce the length of stay in hospital, duration of supplemental oxygen or tube feeding in children hospitalised with moderate-to-severe viral bronchiolitis.

  13. Reducing Postpartum Weight Retention and Improving Breastfeeding Outcomes in Overweight Women: A Pilot Randomised Controlled Trial

    Directory of Open Access Journals (Sweden)

    Julia Martin

    2015-02-01

    Full Text Available Overweight and obesity is prevalent among women of reproductive age (42% BMI > 25 kg/m2 and parity is associated with risk of weight gain. Weight gain greater than that recommended by the Institute of Medicine (IOM is also associated with lower rates of breastfeeding initiation and duration in women. The aim of this pilot randomised controlled trial is to examine the feasibility of recruiting and maintaining a cohort of pregnant women with the view of reducing postpartum weight retention and improving breastfeeding outcomes. Women (BMI of 25–35 kg/m2 (n = 36 were recruited from the John Hunter Hospital antenatal clinic in New South Wales, Australia. Participants were stratified by BMI and randomised to one of three groups with follow-up to six months postpartum. Women received a dietary intervention with or without breastfeeding support from a lactation consultant, or were assigned to a wait-list control group where the dietary intervention was issued at three months postpartum. Feasibility and acceptability was assessed by participation rates and questionnaire. Analysis of variance and covariance was conducted to determine any differences between groups. Sixty-nine per cent of the participants were still enrolled at six months postpartum. This pilot demonstrated some difficulties in recruiting women from antenatal clinics and retaining them in the trial. Although underpowered; the results on weight; biomarkers and breastfeeding outcomes indicated improved metabolic health.

  14. Brachytherapy and percutaneous stenting in the treatment of cholangiocarcinoma: A prospective randomised study

    International Nuclear Information System (INIS)

    Purpose: To evaluate the effect of radiation therapy including intraluminal brachyterapy with iridium-192 on survival of patients with malignant biliary strictures (cholangiocarcinoma, histologically improved) treated with metallic stent in a prospective randomised study. Method and materials: In the prospective randomised study, 21 patients with cholangiocarcinoma were treated with implantation of percutaneous stents followed with intraluminal Ir-192 brachytherapy (mean dose 30 Gy) and external radiotherapy (mean dose 50 Gy) and 21 patients were treated only with stents insertion. We did not find any statistically significant differences in age and tumor localization between these two groups of patients. Results: All the patients died. In the group of patients treated with brachytherapy and with stent implantation, the mean survival time was 387.9 days. In the group of patients treated only with stent insertion the mean survival was 298 days. In effort to eliminate possible effect of external radiotherapy we treated the control group of eight patients with cholangiocarcinoma by stent insertion and brachyterapy only. Conclusion: Our results show that combined radiation therapy could extend the survival in the patients with cholangiocarcinoma obstruction

  15. Tweeting links to Cochrane Schizophrenia Group reviews: a randomised controlled trial

    Science.gov (United States)

    Adams, C E; Bodart, A Y M; Sampson, S; Zhao, S; Montgomery, A A

    2016-01-01

    Objective To assess the effects of using health social media on web activity. Design Individually randomised controlled parallel group superiority trial. Setting Twitter and Weibo. Participants 170 Cochrane Schizophrenia Group full reviews with an abstract and plain language summary web page. Interventions Three randomly ordered slightly different 140 character or less messages, each containing a short URL to the freely accessible summary page sent on specific times on one single day. This was compared with no messaging. Outcome The primary outcome was web page visits at 1 week. Secondary outcomes were other metrics of web activity at 1 week. Results 85 reviews were randomised to each of the intervention and control arms. Google Analytics allowed 100% follow-up within 1 week of completion. Intervention and control reviews received a total of 1162 and 449 visits, respectively (IRR 2.7, 95% CI 2.2 to 3.3). Fewer intervention reviews had single page only visits (16% vs 31%, OR 0.41, 0.19 to 0.88) and users spent more time viewing intervention reviews (geometric mean 76 vs 31 s, ratio 2.5, 1.3 to 4.6). Other secondary metrics of web activity all showed strong evidence in favour of the intervention. Conclusions Tweeting in this limited area of healthcare increases ‘product placement’ of evidence with the potential for that to influence care. Trial registration number ISRCTN84658943. PMID:26956164

  16. Cognitive therapy for internalised stigma in people experiencing psychosis: A pilot randomised controlled trial.

    Science.gov (United States)

    Morrison, Anthony P; Burke, Eilish; Murphy, Elizabeth; Pyle, Melissa; Bowe, Samantha; Varese, Filippo; Dunn, Graham; Chapman, Nicola; Hutton, Paul; Welford, Mary; Wood, Lisa J

    2016-06-30

    We aimed to evaluate the feasibility of Cognitive Therapy (CT) as an intervention for internalised stigma in people with psychosis. We conducted a single-blind randomised controlled pilot trial comparing CT plus treatment as usual (TAU) with TAU only. Participants were assessed at end of treatment (4 months) and follow-up (7 months). Twenty-nine participants with schizophrenia spectrum disorders were randomised. CT incorporated up to 12 sessions over 4 months (mean sessions=9.3). Primary outcome was the Internalised Stigma of Mental Illness Scale - Revised (ISMI-R) total score, which provides a continuous measure of internalised stigma associated with mental health problems. Secondary outcomes included self-rated recovery, internalised shame, emotional problems, hopelessness and self-esteem. Recruitment rates and retention for this trial were good. Changes in outcomes were analysed following the intention-to-treat principle, using ANCOVAs adjusted for baseline symptoms. There was no effect on our primary outcome, with a sizable reduction observed in both groups, but several secondary outcomes were significantly improved in the group assigned to CT, in comparison with TAU, including internalised shame, hopelessness and self-rated recovery. Stigma-focused CT appears feasible and acceptable in people with psychosis who have high levels of internalised stigma. A larger, definitive trial is required. PMID:27092862

  17. Improving health-related fitness in adolescents: the CrossFit Teens™ randomised controlled trial.

    Science.gov (United States)

    Eather, Narelle; Morgan, Philip James; Lubans, David Revalds

    2016-01-01

    The aim of this study was to evaluate the preliminary efficacy and feasibility of the CrossFit Teens™ resistance training programme for improving health-related fitness and resistance training skill competency in adolescents. This assessor-blinded randomised controlled trial was conducted in one secondary school in the Hunter Region, Australia, from July to September 2013. Ninety-six (96) students (age = 15.4 (.5) years, 51.5% female) were randomised into intervention (n = 51) or control (n = 45) conditions for 8-weeks (60 min twice per week). Waist circumference, body mass index (BMI), BMI-Z score (primary outcomes), cardiorespiratory fitness (shuttle run test), muscular fitness (standing jump, push-up, handgrip, curl-up test), flexibility (sit and reach) and resistance training skill competency were measured at baseline and immediate post-intervention. Feasibility measures of recruitment, retention, adherence and satisfaction were assessed. Significant group-by-time intervention effects were found for waist circumference [-3.1 cm, P CrossFit Teens™ is a feasible and efficacious programme for improving health-related fitness in adolescents. PMID:25972203

  18. Live lecture versus video podcast in undergraduate medical education: A randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Fukuta Junaid

    2010-10-01

    Full Text Available Abstract Background Information technology is finding an increasing role in the training of medical students. We compared information recall and student experience and preference after live lectures and video podcasts in undergraduate medical education. Methods We performed a crossover randomised controlled trial. 100 students were randomised to live lecture or video podcast for one clinical topic. Live lectures were given by the same instructor as the narrator of the video podcasts. The video podcasts comprised Powerpoint™ slides narrated using the same script as the lecture. They were then switched to the other group for a second clinical topic. Knowledge was assessed using multiple choice questions and qualitative information was collected using a questionnaire. Results No significant difference was found on multiple choice questioning immediately after the session. The subjects enjoyed the convenience of the video podcast and the ability to stop, review and repeat it, but found it less engaging as a teaching method. They expressed a clear preference for the live lecture format. Conclusions We suggest that video podcasts are not ready to replace traditional teaching methods, but may have an important role in reinforcing learning and aiding revision.

  19. Anteroposterior glide versus rotating platform low contact stress (LCS knee arthroplasty: a randomised controlled trial

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    Wynn-Jones Charles

    2007-08-01

    Full Text Available Abstract Background Fifty thousand knee replacements are performed annually in the UK at an estimated cost of £150 million. Post-operative improvement depends on a number of factors including implant design and patient associated factors. To our knowledge there are no published study's comparing the results of AP glide and rotating platform designs of LCS knee arthroplasty. Therefore we feel that a study is required to investigate and compare the effects of two types of LCS total knee arthroplasty on joint proprioception and range of motion. Methods/Design Patients will be randomised to receive either a LCS AP glide or Rotating platform prosthesis. Clinical scores (Oxford knee score, American knee society score, EuroQol, range of motion and proprioception will be assessed prior to and at 3,6, 12 and 24 months after the operation. Proprioception will be assessed in terms of absolute error angle (mean difference between the target angle and the response angle. Knee angles will be measured in degrees using an electromagnetic tracking device, Polhemus 3Space Fastrak that detects positions of sensors placed on the test limb. Student's t-test will be used to compare the mean of two groups. Discussion Evidence is lacking concerning the best prosthesis to use for patients undergoing total knee replacement. This pragmatic randomised trial will test the null hypothesis that anteroposterior glide LCS knee arthroplasty does not result in better post operative knee motion and proprioception as compared to rotating platform LCS knee. Trial Registration ISRCTN52943804

  20. Economic evaluation alongside pragmatic randomised trials: developing a standard operating procedure for clinical trials units

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    Russell Ian T

    2008-11-01

    Full Text Available Abstract Background There is wide recognition that pragmatic randomised trials are the best vehicle for economic evaluation. This is because trials provide the best chance of ensuring internal validity, not least through the rigorous prospective collection of patient-specific data. Furthermore the marginal cost of collecting economic data alongside clinical data is typically modest. UK Clinical Research Collaboration (UKCRC does not require a standard operating procedure (SOP for economic evaluation as a prerequisite for trial unit registration. We judge that such a SOP facilitates the integration of health economics into trials. Methods A collaboration between health economists and trialists at Bangor University led to the development of a SOP for economic evaluation alongside pragmatic trials, in addition to the twenty SOPs required by UKCRC for registration, which include randomisation, data management and statistical analysis. Results Our recent telephone survey suggests that no other UKCRC-registered trials unit currently has an economic SOP. Conclusion We argue that UKCRC should require, from all Trials Units undertaking economic evaluation and seeking registration or re-registration, a SOP for economic evaluation as one of their portfolio of supporting SOPs.