WorldWideScience

Sample records for cadet multi-centre randomised

  1. Low sodium diet and pregnancy-induced hypertension: a multi-centre randomised controlled trial

    NARCIS (Netherlands)

    Knuist, M.; Bonsel, G. J.; Zondervan, H. A.; Treffers, P. E.

    1998-01-01

    To examine the effectiveness of the standard policy in the Netherlands to prescribe a sodium restricted diet to prevent or to treat mild pregnancy-induced hypertension. Multi-centre randomised controlled trial between April 1992 and April 1994. Seven practices of independent midwives and one

  2. Outcome of physiotherapy after surgery for cervical disc disease: a prospective randomised multi-centre trial

    Science.gov (United States)

    2014-01-01

    Background Many patients with cervical disc disease require leave from work, due to long-lasting, complex symptoms, including chronic pain and reduced levels of physical and psychological function. Surgery on a few segmental levels might be expected to resolve disc-specific pain and reduce neurological deficits, but not the non-specific neck pain and the frequent illness. No study has investigated whether post-surgery physiotherapy might improve the outcome of surgery. The main purpose of this study was to evaluate whether a well-structured rehabilitation programme might add benefit to the customary post-surgical treatment for cervical disc disease, with respect to function, disability, work capability, and cost effectiveness. Methods/Design This study was designed as a prospective, randomised, controlled, multi-centre study. An independent, blinded investigator will compare two alternatives of rehabilitation. We will include 200 patients of working age, with cervical disc disease confirmed by clinical findings and symptoms of cervical nerve root compression. After providing informed consent, study participants will be randomised to one of two alternative physiotherapy regimes; (A) customary treatment (information and advice on a specialist clinic); or (B) customary treatment plus active physiotherapy. Physiotherapy will follow a standardised, structured programme of neck-specific exercises combined with a behavioural approach. All patients will be evaluated both clinically and subjectively (with questionnaires) before surgery and at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. The main outcome variable will be neck-specific disability. Cost-effectiveness will also be calculated. Discussion We anticipate that the results of this study will provide evidence to support physiotherapeutic rehabilitation applied after surgery for cervical radiculopathy due to cervical disc disease. Trial registration ClinicalTrials.gov identifier: NCT01547611

  3. 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

  4. Psychological and psychosocial functioning of children with burn scarring using cosmetic camouflage: a multi-centre prospective randomised controlled trial.

    Science.gov (United States)

    Maskell, Jessica; Newcombe, Peter; Martin, Graham; Kimble, Roy

    2014-02-01

    Burns leave patients with long-term physical scarring. Children with scarring are required to face challenges of reintegration into their community, including acceptance of an altered appearance and acceptance by others. This can be difficult given society's preoccupation with physical appearance. Limited research exists investigating validity of cosmetic camouflage as a psychosocial intervention for children with scarring. This study investigated whether using cosmetic camouflage (Microskin™) had a positive impact on health-related quality of life, self-concept and psychopathology for children and adolescents (8-17 years) with burn scarring. A prospective multi-centre randomised controlled trial was conducted across Australian and New Zealand paediatric hospitals. 63 participants (49 females, mean age 12.7 ± 2.1 years) were enrolled. Data points were baseline (Time 1) and at 8 weeks (Time 2) using reliable and valid psychometric measures. Findings indicate there were significant improvements in socialisation, school and appearance scales on the Paediatric Quality of Life Inventory and psychopathology scores particularly peer problems decreased. However self-concept remained stable from baseline throughout intervention use. Cosmetic camouflage appears to have a positive impact on quality of life particularly socialisation. Cosmetic camouflage is a valid tool to assist children with scarring to actively participate socially within their communities. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

  5. 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....

  6. Short video interventions to reduce mental health stigma: a multi-centre randomised controlled trial in nursing high schools.

    Science.gov (United States)

    Winkler, Petr; Janoušková, Miroslava; Kožený, Jiří; Pasz, Jiří; Mladá, Karolína; Weissová, Aneta; Tušková, Eva; Evans-Lacko, Sara

    2017-12-01

    We aimed to assess whether short video interventions could reduce stigma among nursing students. A multi-centre, randomised controlled trial was conducted. Participating schools were randomly selected and randomly assigned to receive: (1) an informational leaflet, (2) a short video intervention or (3) a seminar involving direct contact with a service user. The Community Attitudes towards Mental Illness (CAMI) and Reported and Intended Behaviour Scale (RIBS) were selected as primary outcome measures. SPANOVA models were built and Cohen's d calculated to assess the overall effects in each of the trial arms. Compared to the baseline, effect sizes immediately after the intervention were small in the flyer arm (CAMI: d = 0.25; RIBS: d = 0.07), medium in the seminar arm (CAMI: d = 0.61; RIBS: d = 0.58), and medium in the video arm (CAMI: d = 0.49 RIBS: d = 0.26; n = 237). Effect sizes at the follow-up were vanishing in the flyer arm (CAMI: d = 0.05; RIBS: d = 0.04), medium in the seminar arm (CAMI: d = 0.43; RIBS: d = 0.26; n = 254), and small in the video arm (CAMI: d = 0.22 RIBS: d = 0.21; n = 237). Seminar had the strongest and relatively stable effect on students' attitudes and intended behaviour, but the effect of short video interventions was also considerable and stable over time. Since short effective video interventions are relatively cheap, conveniently accessible and easy to disseminate globally, we recommend them for further research and development.

  7. 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

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

    Science.gov (United States)

    Freeman, Jennifer; Fox, Esther; Gear, Margaret; Hough, Alan

    2012-04-05

    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 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 abdominal muscles will be performed before

  9. 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.

  10. A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol

    Directory of Open Access Journals (Sweden)

    Norrie John

    2010-04-01

    Full Text Available Abstract Background Patients undergoing major elective or urgent surgery are at high risk of death or significant morbidity. Measures to reduce this morbidity and mortality include pre-operative optimisation and use of higher levels of dependency care after surgery. We propose a pragmatic multi-centre randomised controlled trial of level of dependency and pre-operative fluid therapy in high-risk surgical patients undergoing major elective surgery. Methods/Design A multi-centre randomised controlled trial with a 2 * 2 factorial design. The first randomisation is to pre-operative fluid therapy or standard regimen and the second randomisation is to routine intensive care versus high dependency care during the early post-operative period. We intend to recruit 204 patients undergoing major elective and urgent abdominal and thoraco-abdominal surgery who fulfil high-risk surgical criteria. The primary outcome for the comparison of level of care is cost-effectiveness at six months and for the comparison of fluid optimisation is the number of hospital days after surgery. Discussion We believe that the results of this study will be invaluable in determining the future care and clinical resource utilisation for this group of patients and thus will have a major impact on clinical practice. Trial Registration Trial registration number - ISRCTN32188676

  11. Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial

    Science.gov (United States)

    Hollands, Kristen L.; Pelton, Trudy A.; Wimperis, Andrew; Whitham, Diane; Tan, Wei; Jowett, Sue; Sackley, Catherine M.; Wing, Alan M.; Tyson, Sarah F.; Mathias, Jonathan; Hensman, Marianne; van Vliet, Paulette M.

    2015-01-01

    Objectives Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. Design This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services Participants Community dwelling stroke survivors with walking speed adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Trial Registration Clinicaltrials.gov NCT01600391 PMID:26445137

  12. 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

  13. The effects of a randomised multi-centre trial and international accreditation on availability and quality of clinical guidelines

    DEFF Research Database (Denmark)

    Juul, Anne Benedicte; Gluud, Christian; Wetterslev, Jørn

    2005-01-01

    To examine the availability and quality of clinical guidelines on perioperative diabetes care in hospital units before and after a randomised clinical trial (RCT) and international accreditation.......To examine the availability and quality of clinical guidelines on perioperative diabetes care in hospital units before and after a randomised clinical trial (RCT) and international accreditation....

  14. 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

  15. Involving older people in a multi-centre randomised trial of a complex intervention in pre-hospital emergency care: implementation of a collaborative model.

    Science.gov (United States)

    Koniotou, Marina; Evans, Bridie Angela; Chatters, Robin; Fothergill, Rachael; Garnsworthy, Christopher; Gaze, Sarah; Halter, Mary; Mason, Suzanne; Peconi, Julie; Porter, Alison; Siriwardena, A Niroshan; Toghill, Alun; Snooks, Helen

    2015-07-10

    Health services research is expected to involve service users as active partners in the research process, but few examples report how this has been achieved in practice in trials. We implemented a model to involve service users in a multi-centre randomised controlled trial in pre-hospital emergency care. We used the generic Standard Operating Procedure (SOP) from our Clinical Trials Unit (CTU) as the basis for creating a model to fit the context and population of the SAFER 2 trial. In our model, we planned to involve service users at all stages in the trial through decision-making forums at 3 levels: 1) strategic; 2) site (e.g. Wales; London; East Midlands); 3) local. We linked with charities and community groups to recruit people with experience of our study population. We collected notes of meetings alongside other documentary evidence such as attendance records and study documentation to track how we implemented our model. We involved service users at strategic, site and local level. We also added additional strategic level forums (Task and Finish Groups and Writing Days) where we included service users. Service user involvement varied in frequency and type across meetings, research stages and locations but stabilised and increased as the trial progressed. Involving service users in the SAFER 2 trial showed how it is feasible and achievable for patients, carers and potential patients sharing the demographic characteristics of our study population to collaborate in a multi-centre trial at the level which suited their health, location, skills and expertise. A standard model of involvement can be tailored by adopting a flexible approach to take account of the context and complexities of a multi-site trial. Current Controlled Trials ISRCTN60481756. Registered: 13 March 2009.

  16. 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

    This randomised controlled study compared the efficacy of double-balloon catheter versus vaginal prostaglandin E2 (dinoprostone) for induction of labour. In total, 825 pregnant women with cephalic presentation and an unfavourable cervix undergoing induction for conventional indications were...... randomised to double-balloon or vaginal dinoprostone (3 mg) groups. There was a significantly higher failure rate for labour induction in the balloon group (relative risk: 1.25, 95% confidence interval [CI]: 1.02-1.49). Median induction time was 27.3 h in the balloon group and 29.8 h in the dinoprostone...

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

    Directory of Open Access Journals (Sweden)

    Grotenhuis J André

    2007-11-01

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

  18. Protocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED trial: A multi-centre, double-masked, factorial randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Kingston Laura

    2008-01-01

    Full Text Available Abstract Background Medical management of thyroid eye disease remains controversial due to a paucity of high quality evidence on long-term treatment outcomes. Glucocorticoids are known to be effective initially but have significant side-effects with long-term use and recrudescence can occur on cessation. Current evidence is conflicting on the efficacy of radiotherapy and non-steroid systemic immunosuppression, and the majority of previous studies have been retrospective, uncontrolled, small or poorly designed. The Combined Immunosuppression and Radiotherapy in Thyroid Eye Disease (CIRTED trial was designed to investigate the efficacy of radiotherapy and azathioprine in combination with a standard course of oral prednisolone in patients with active thyroid eye disease. Methods/design Patients with active thyroid eye disease will be randomised to receive (i azathioprine or oral placebo and (ii radiotherapy or sham-radiotherapy in this multi-centre, factorial randomised control trial. The primary outcome is improvement in disease severity (assessed using a composite binary measure at 12 months and secondary end-points include quality of life scores and health economic measures. Discussion The CIRTED trial is the first study to evaluate the role of radiotherapy and azathioprine as part of a long-term, combination immunosuppressive treatment regime for Thyroid Eye Disease. It will provide evidence for the role of radiotherapy and prolonged immunosuppression in the management of this condition, as well as pilot data on their use in combination. We have paid particular attention in the trial design to establishing (a robust placebo controls and masking protocols which are effective and safe for both radiotherapy and the systemic administration of an antiproliferative drug; (b constructing effective inclusion and exclusion criteria to select for active disease; and (c selecting pragmatic outcome measures. Trial registration Current controlled trials

  19. A pragmatic randomised multi-centre trial of multifamily and single family therapy for adolescent anorexia nervosa.

    Science.gov (United States)

    Eisler, Ivan; Simic, Mima; Hodsoll, John; Asen, Eia; Berelowitz, Mark; Connan, Frances; Ellis, Gladys; Hugo, Pippa; Schmidt, Ulrike; Treasure, Janet; Yi, Irene; Landau, Sabine

    2016-11-24

    Considerable progress has been made in recent years in developing effective treatments for child and adolescent anorexia nervosa, with a general consensus in the field that eating disorders focussed family therapy (often referred to as Maudsley Family Therapy or Family Based Treatment) currently offers the most promising outcomes. Nevertheless, a significant number do not respond well and additional treatment developments are needed to improve outcomes. Multifamily therapy is a promising treatment that has attracted considerable interest and we report the results of the first randomised controlled trial of multifamily therapy for adolescent anorexia nervosa. The study was a pragmatic multicentre randomised controlled superiority trial comparing two outpatient eating disorder focussed family interventions - multifamily therapy (MFT-AN) and single family therapy (FT-AN). A total of 169 adolescents with a DSM-IV diagnosis of anorexia nervosa or eating disorder not otherwise specified (restricting type) were randomised to the two treatments using computer generated blocks of random sizes to ensure balanced numbers in the trial arms. Independent assessors, blind to the allocation, completed evaluations at baseline, 3 months, 12 months (end of treatment) and 18 months. Both treatment groups showed clinically significant improvements with just under 60% achieving a good or intermediate outcome (on the Morgan-Russell scales) at the end of treatment in the FT-AN group and more than 75% in the MFT-AN group - a statistically significant benefit in favour of the multifamily intervention (OR = 2.55 95%; CI 1.17, 5.52; p = 0.019). At follow-up (18 months post baseline) there was relatively little change compared to end of treatment although the difference in primary outcome between the treatments was no longer statistically significant. Clinically significant gains in weight were accompanied by improvements in mood and eating disorder psychopathology. Approximately

  20. A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer

    International Nuclear Information System (INIS)

    Borstlap, W. A. A.; Tanis, P. J.; Koedam, T. W. A.; Marijnen, C. A. M.; Cunningham, C.

    2016-01-01

    Rectal cancer surgery is accompanied with high morbidity and poor long term functional outcome. Screening programs have shown a shift towards more early staged cancers. Patients with early rectal cancer can potentially benefit significantly from rectal preserving therapy. For the earliest stage cancers, local excision is sufficient when the risk of lymph node disease and subsequent recurrence is below 5 %. However, the majority of early cancers are associated with an intermediate risk of lymph node involvement (5–20 %) suggesting that local excision alone is not sufficient, while completion radical surgery, which is currently standard of care, could be a substantial overtreatment for this group of patients. In this multicentre randomised trial, patients with an intermediate risk T1-2 rectal cancer, that has been locally excised using an endoluminal technique, will be randomized between adjuvant chemo-radiotherapylimited to the mesorectum and standard completion total mesorectal excision (TME). To strictly monitor the risk of locoregional recurrence in the experimental arm and enable early salvage surgery, there will be additional follow up with frequent MRI and endoscopy. The primary outcome of the study is three-year local recurrence rate. Secondary outcomes are morbidity, disease free and overall survival, stoma rate, functional outcomes, health related quality of life and costs. The design is a non inferiority study with a total sample size of 302 patients. The results of the TESAR trial will potentially demonstrate that adjuvant chemoradiotherapy is an oncological safe treatment option in patients who are confronted with the difficult clinical dilemma of a radically removed intermediate risk early rectal cancer by polypectomy or transanal surgery that is conventionally treated with subsequent radical surgery. Preserving the rectum using adjuvant radiotherapy is expected to significantly improve morbidity, function and quality of life if compared to completion

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

    Science.gov (United States)

    Snowdon, Claire; Elbourne, Diana R; Garcia, Jo; Campbell, Marion K; Entwistle, Vikki A; Francis, David; Grant, Adrian M; Knight, Rosemary C; McDonald, Alison M; Roberts, Ian

    2006-12-21

    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). 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. 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. This study highlights complex financial aspects of planning and conducting trials, especially where multiple funders are involved. Recognition of the importance of financial

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

    Directory of Open Access Journals (Sweden)

    Grant Adrian M

    2006-12-01

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

  3. A randomised, double-blind, multi-centre trial comparing vasopressin and adrenaline in patients with cardiac arrest presenting to or in the Emergency Department.

    Science.gov (United States)

    Ong, Marcus Eng Hock; Tiah, Ling; Leong, Benjamin Sieu-Hon; Tan, Elaine Ching Ching; Ong, Victor Yeok Kein; Tan, Elizabeth Ai Theng; Poh, Bee Yen; Pek, Pin Pin; Chen, Yuming

    2012-08-01

    To compare vasopressin and adrenaline in the treatment of patients with cardiac arrest presenting to or in the Emergency Department (ED). A randomised, double-blind, multi-centre, parallel-design clinical trial in four adult hospitals. Eligible cardiac arrest patients (confirmed by the absence of pulse, unresponsiveness and apnea) aged >16 (aged>21 for one hospital) were randomly assigned to intravenous adrenaline (1mg) or vasopressin (40 IU) at ED. Patients with traumatic cardiac arrest or contraindication for cardiopulmonary resuscitation (CPR) were excluded. Patients received additional open label doses of adrenaline as per current guidelines. Primary outcome was survival to hospital discharge (defined as participant discharged alive or survival to 30 days post-arrest). The study recruited 727 participants (adrenaline = 353; vasopressin = 374). Baseline characteristics of the two groups were comparable. Eight participants (2.3%) from adrenaline and 11 (2.9%) from vasopressin group survived to hospital discharge with no significant difference between groups (p = 0.27, RR = 1.72, 95% CI = 0.65-4.51). After adjustment for race, medical history, bystander CPR and prior adrenaline given, more participants survived to hospital admission with vasopressin (22.2%) than with adrenaline (16.7%) (p = 0.05, RR = 1.43, 95% CI = 1.02-2.04). Sub-group analysis suggested improved outcomes for vasopressin in participants with prolonged arrest times. Combination of vasopressin and adrenaline did not improve long term survival but seemed to improve survival to admission in patients with prolonged cardiac arrest. Further studies on the effect of vasopressin combined with therapeutic hypothermia on patients with prolonged cardiac arrest are needed. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  4. Oxygen titration after resuscitation from out-of-hospital cardiac arrest: a multi-centre, randomised controlled pilot study (the EXACT pilot trial).

    Science.gov (United States)

    Bray, Janet E; Hein, Cindy; Smith, Karen; Stephenson, Michael; Grantham, Hugh; Finn, Judith; Stub, Dion; Cameron, Peter

    2018-04-20

    Recent studies suggest the administration of 100% oxygen to hyperoxic levels following return-of-spontaneous-circulation (ROSC) post-cardiac arrest may be harmful. However, the feasibility and safety of oxygen titration in the prehospital setting is unknown. We conducted a multi-centre, phase-2 study testing whether prehospital titration of oxygen results in an equivalent number of patients arriving at hospital with oxygen saturations SpO2 ≥ 94%. We enrolled unconscious adults with: sustained ROSC; initial shockable rhythm; an advanced airway; and an SpO2 ≥ 95%. Initially (Sept 2015-March 2016) patients were randomised 1:1 to either 2 litres/minute (L/min) oxygen (titrated) or >10 L/min oxygen (control) via a bag-valve reservoir. However, one site experienced a high number of desaturations (SpO2 titrated arm and this arm was changed (April 2016) to an initial reduction of oxygen to 4 L/min then, if tolerated, to 2 L/min, and the desaturation limit was decreased to titrated (n = 37: 2L/min = 20 and 2-4 L/min = 17) oxygen or control (n = 24). Patients allocated to titrated oxygen were more likely to desaturate compared to controls ((SpO2 titrated: 90% vs. control: 100%) and all patients had a SpO2 ≥ 90%. One patient (control) re-arrested. Survival to hospital discharge was similar. Oxygen titration post-ROSC is feasible in the prehospital environment, but incremental titration commencing at 4L/min oxygen flow may be needed to maintain an oxygen saturation >90% (NCT02499042). Copyright © 2018. Published by Elsevier B.V.

  5. 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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    Bateman James

    2012-08-01

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

  7. 12 A multi-centre randomised feasibility study evaluating the impact of a prognostic model for management of blunt chest wall trauma patients: stumbl trial.

    Science.gov (United States)

    Battle, Ceri; Hutchings, Hayley; Abbott, Zoe; O'neill, Claire; Groves, Sam; Watkins, Alan; Lecky, Fiona; Jones, Sally; Gagg, James; Body, Rick; Evans, Phillip

    2017-12-01

    A new prognostic model has been developed and externally validated, the aim of which is to assist in the management of the blunt chest wall trauma patient in the Emergency Department (ED). A definitive randomised controlled trial (impact trial), is required to assess the clinical and cost effectiveness of the new model, before it can be accepted in clinical practice. The purpose of this trial is to assess the feasibility and acceptability of such a definitive trial and inform its design. This feasibility trial is designed to test the methods of a multi-centre, cluster-randomised (stepped wedge) trial, with a substantial qualitative component. Four EDs in England and Wales will collect data for all blunt chest wall trauma patients over a five month period; in the initial period acting as the controls (normal care) and the second period, acting as the interventions (in which the new model will be used). Baseline measurements including completion of the SF-12v2 will be obtained on initial assessment in the ED. Patient outcome data will then be collected for any subsequent hospitalisations. Data collection will conclude with a six week follow-up completion of two surveys (SF-12v2 and Client Services Receipt Inventory).Analysis of outcomes will focus on feasibility, acceptability and trial processes and will include recruitment and retention rates, attendance at clinician training rates and use of model in the ED. Qualitative feedback will be obtained through clinician interviews and a research nurse focus group. An evaluation of the feasibility of health economics outcomes data will be completed. Wales Research Ethics Committee 6 granted approval for the trial in September 2016. Health Care Research Wales Research Permissions and the HRA have granted approval for the study. Patient recruitment commenced in February 2017. Planned dissemination is through publication in a peer-reviewed Emergency Medicine Journal, presentation at appropriate conferences and to

  8. Protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): the Australian FASHIoN trial.

    Science.gov (United States)

    Murphy, Nicholas J; Eyles, Jillian; Bennell, Kim L; Bohensky, Megan; Burns, Alexander; Callaghan, Fraser M; Dickenson, Edward; Fary, Camdon; Grieve, Stuart M; Griffin, Damian R; Hall, Michelle; Hobson, Rachel; Kim, Young Jo; Linklater, James M; Lloyd, David G; Molnar, Robert; O'Connell, Rachel L; O'Donnell, John; O'Sullivan, Michael; Randhawa, Sunny; Reichenbach, Stephan; Saxby, David J; Singh, Parminder; Spiers, Libby; Tran, Phong; Wrigley, Tim V; Hunter, David J

    2017-09-26

    Femoroacetabular impingement syndrome (FAI), a hip disorder affecting active young adults, is believed to be a leading cause of hip osteoarthritis (OA). Current management approaches for FAI include arthroscopic hip surgery and physiotherapy-led non-surgical care; however, there is a paucity of clinical trial evidence comparing these approaches. In particular, it is unknown whether these management approaches modify the future risk of developing hip OA. The primary objective of this randomised controlled trial is to determine if participants with FAI who undergo hip arthroscopy have greater improvements in hip cartilage health, as demonstrated by changes in delayed gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) index between baseline and 12 months, compared to those who undergo physiotherapy-led non-surgical management. This is a pragmatic, multi-centre, two-arm superiority randomised controlled trial comparing hip arthroscopy to physiotherapy-led management for FAI. A total of 140 participants with FAI will be recruited from the clinics of participating orthopaedic surgeons, and randomly allocated to receive either surgery or physiotherapy-led non-surgical care. The surgical intervention involves arthroscopic FAI surgery from one of eight orthopaedic surgeons specialising in this field, located in three different Australian cities. The physiotherapy-led non-surgical management is an individualised physiotherapy program, named Personalised Hip Therapy (PHT), developed by a panel to represent the best non-operative care for FAI. It entails at least six individual physiotherapy sessions over 12 weeks, and up to ten sessions over six months, provided by experienced musculoskeletal physiotherapists trained to deliver the PHT program. The primary outcome measure is the change in dGEMRIC score of a ROI containing both acetabular and femoral head cartilages at the chondrolabral transitional zone of the mid-sagittal plane between baseline and

  9. Effects of a partially supervised conditioning programme in cystic fibrosis: an international multi-centre randomised controlled trial (ACTIVATE-CF): study protocol.

    Science.gov (United States)

    Hebestreit, Helge; Lands, Larry C; Alarie, Nancy; Schaeff, Jonathan; Karila, Chantal; Orenstein, David M; Urquhart, Don S; Hulzebos, Erik H J; Stein, Lothar; Schindler, Christian; Kriemler, Susi; Radtke, Thomas

    2018-02-08

    Physical activity (PA) and exercise have become an accepted and valued component of cystic fibrosis (CF) care. Regular PA and exercise can positively impact pulmonary function, improve physical fitness, and enhance health-related quality of life (HRQoL). However, motivating people to be more active is challenging. Supervised exercise programs are expensive and labour intensive, and adherence falls off significantly once supervision ends. Unsupervised or partially supervised programs are less costly and more flexible, but compliance can be more problematic. The primary objective of this study is to evaluate the effects of a partially supervised exercise intervention along with regular motivation on forced expiratory volume in 1 s (FEV 1 ) at 6 months in a large international group of CF patients. Secondary endpoints include patient reported HRQoL, as well as levels of anxiety and depression, and control of blood sugar. It is planned that a total of 292 patients with CF 12 years and older with a FEV 1  ≥ 35% predicted shall be randomised. Following baseline assessments (2 visits) patients are randomised into an intervention and a control group. Thereafter, they will be seen every 3 months for assessments in their centre for one year (4 follow-up visits). Along with individual counselling to increase vigorous PA by at least 3 h per week on each clinic visit, the intervention group documents daily PA and inactivity time and receives a step counter to record their progress within a web-based diary. They also receive monthly phone calls from the study staff during the first 6 months of the study. After 6 months, they continue with the step counter and web-based programme for a further 6 months. The control group receives standard care and keeps their PA level constant during the study period. Thereafter, they receive the intervention as well. This is the first large, international multi-centre study to investigate the effects of a PA intervention in CF with

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

    Science.gov (United States)

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

    2013-01-01

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

  11. REMCARE: Pragmatic Multi-Centre Randomised Trial of Reminiscence Groups for People with Dementia and their Family Carers: Effectiveness and Economic Analysis.

    Directory of Open Access Journals (Sweden)

    Robert T Woods

    Full Text Available Joint reminiscence groups, involving people with dementia and family carers together, are popular, but the evidence-base is limited. This study aimed to assess the effectiveness and cost-effectiveness of joint reminiscence groups as compared to usual care.This multi-centre, pragmatic randomised controlled trial had two parallel arms: intervention group and usual-care control group. A restricted dynamic method of randomisation was used, with an overall allocation ratio of 1:1, restricted to ensure viable sized intervention groups. Assessments, blind to treatment allocation, were carried out at baseline, three months and ten months (primary end-point, usually in the person's home. Participants were recruited in eight centres, mainly through NHS Memory Clinics and NHS community mental health teams. Included participants were community resident people with mild to moderate dementia (DSM-IV, who had a relative or other care-giver in regular contact, to act as informant and willing and able to participate in intervention. 71% carers were spouses. 488 people with dementia (mean age 77.5were randomised: 268 intervention, 220 control; 350 dyads completed the study (206 intervention, 144 control. The intervention evaluated was joint reminiscence groups (with up to 12 dyads weekly for twelve weeks; monthly maintenance sessions for further seven months. Sessions followed a published treatment manual and were held in a variety of community settings. Two trained facilitators in each centre were supported by volunteers. Primary outcome measures were self-reported quality of life for the person with dementia (QoL-AD, psychological distress for the carer (General Health Questionnaire, GHQ-28. Secondary outcome measures included: autobiographical memory and activities of daily living for the person with dementia; carer stress for the carer; mood, relationship quality and service use and costs for both.The intention to treat analysis (ANCOVA identified no

  12. A pragmatic multi-centre randomised controlled trial of fluid loading in high-risk surgical patients undergoing major elective surgery--the FOCCUS study.

    Science.gov (United States)

    Cuthbertson, Brian H; Campbell, Marion K; Stott, Stephen A; Elders, Andrew; Hernández, Rodolfo; Boyers, Dwayne; Norrie, John; Kinsella, John; Brittenden, Julie; Cook, Jonathan; Rae, Daniela; Cotton, Seonaidh C; Alcorn, David; Addison, Jennifer; Grant, Adrian

    2011-01-01

    Fluid strategies may impact on patient outcomes in major elective surgery. We aimed to study the effectiveness and cost-effectiveness of pre-operative fluid loading in high-risk surgical patients undergoing major elective surgery. This was a pragmatic, non-blinded, multi-centre, randomised, controlled trial. We sought to recruit 128 consecutive high-risk surgical patients undergoing major abdominal surgery. The patients underwent pre-operative fluid loading with 25 ml/kg of Ringer's solution in the six hours before surgery. The control group had no pre-operative fluid loading. The primary outcome was the number of hospital days after surgery with cost-effectiveness as a secondary outcome. A total of 111 patients were recruited within the study time frame in agreement with the funder. The median pre-operative fluid loading volume was 1,875 ml (IQR 1,375 to 2,025) in the fluid group compared to 0 (IQR 0 to 0) in controls with days in hospital after surgery 12.2 (SD 11.5) days compared to 17.4 (SD 20.0) and an adjusted mean difference of 5.5 days (median 2.2 days; 95% CI -0.44 to 11.44; P = 0.07). There was a reduction in adverse events in the fluid intervention group (P = 0.048) and no increase in fluid based complications. The intervention was less costly and more effective (adjusted average cost saving: £2,047; adjusted average gain in benefit: 0.0431 quality adjusted life year (QALY)) and has a high probability of being cost-effective. Pre-operative intravenous fluid loading leads to a non-significant reduction in hospital length of stay after high-risk major surgery and is likely to be cost-effective. Confirmatory work is required to determine whether these effects are reproducible, and to confirm whether this simple intervention could allow more cost-effective delivery of care. Prospective Clinical Trials, ISRCTN32188676.

  13. Evaluating the PRASE patient safety intervention - a multi-centre, cluster trial with a qualitative process evaluation: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Sheard, Laura; O'Hara, Jane; Armitage, Gerry; Wright, John; Cocks, Kim; McEachan, Rosemary; Watt, Ian; Lawton, Rebecca

    2014-10-29

    Estimates show that as many as one in 10 patients are harmed while receiving hospital care. Previous strategies to improve safety have focused on developing incident reporting systems and changing systems of care and professional behaviour, with little involvement of patients. The need to engage with patients about the quality and safety of their care has never been more evident with recent high profile reviews of poor hospital care all emphasising the need to develop and support better systems for capturing and responding to the patient perspective on their care. Over the past 3 years, our research team have developed, tested and refined the PRASE (Patient Reporting and Action for a Safe Environment) intervention, which gains patient feedback about quality and safety on hospital wards. A multi-centre, cluster, wait list design, randomised controlled trial with an embedded qualitative process evaluation. The aim is to assess the efficacy of the PRASE intervention, in achieving patient safety improvements over a 12-month period.The trial will take place across 32 hospital wards in three NHS Hospital Trusts in the North of England. The PRASE intervention comprises two tools: (1) a 44-item questionnaire which asks patients about safety concerns and issues; and (2) a proforma for patients to report (a) any specific patient safety incidents they have been involved in or witnessed and (b) any positive experiences. These two tools then provide data which are fed back to wards in a structured feedback report. Using this report, ward staff are asked to hold action planning meetings (APMs) in order to action plan, then implement their plans in line with the issues raised by patients in order to improve patient safety and the patient experience.The trial will be subjected to a rigorous qualitative process evaluation which will enable interpretation of the trial results. fieldworker diaries, ethnographic observation of APMs, structured interviews with APM lead and collection

  14. 'Away Days' in multi-centre randomised controlled trials: a questionnaire survey of their use and a case study on the effect of one Away Day on patient recruitment.

    Science.gov (United States)

    Jefferson, Laura; Cook, Liz; Keding, Ada; Brealey, Stephen; Handoll, Helen; Rangan, Amar

    2015-11-06

    'Away Days' (trial promotion and training events for trial site personnel) are a well-established method used by trialists to encourage engagement of research sites in the recruitment of patients to multi-centre randomised controlled trials (RCTs). We explored the use of Away Days in multi-centre RCTs and analysed the effect on patient recruitment in a case study. Members of the United Kingdom Trial Managers' Network were surveyed in June 2013 to investigate their experiences in the design and conduct of Away Days in RCTs. We used data from a multi-centre pragmatic surgical trial to explore the effects of an Away Day on the screening and recruitment of patients. A total of 94 people responded to the survey. The majority (78%), who confirmed had organised an Away Day previously, found them to be useful. This is despite their costs.. There was no evidence, however, from the analysis of data from a surgical trial that attendance at an Away Day increased the number of patients screened or recruited at participating sites. Although those responsible for managing RCTs in the UK tend to believe that trial Away Days are beneficial, evidence from a multi-centre surgical trial shows no improvement on a key indicator of trial success. This points to the need to carefully consider the aims, design and conduct of Away Days. Further more rigorous research nested within RCTs would be valuable to evaluate the design and conduct of Away Days. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Maffulli Nicola

    2009-11-01

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

  16. 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.

    Science.gov (United States)

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

    2013-01-07

    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. 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. 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. ISRCTN94863788--SOSTA--net: Group-based social skills training in children and adolescents with high functioning autism spectrum disorder.

  17. 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.

  18. Clinical effectiveness of collaborative care for depression in UK primary care (CADET): cluster randomised controlled trial.

    Science.gov (United States)

    Richards, David A; Hill, Jacqueline J; Gask, Linda; Lovell, Karina; Chew-Graham, Carolyn; Bower, Peter; Cape, John; Pilling, Stephen; Araya, Ricardo; Kessler, David; Bland, J Martin; Green, Colin; Gilbody, Simon; Lewis, Glyn; Manning, Chris; Hughes-Morley, Adwoa; Barkham, Michael

    2013-08-19

    To compare the clinical effectiveness of collaborative care with usual care in the management of patients with moderate to severe depression. Cluster randomised controlled trial. 51 primary care practices in three primary care districts in the United Kingdom. 581 adults aged 18 years and older who met ICD-10 (international classification of diseases, 10th revision) criteria for a depressive episode on the revised Clinical Interview Schedule. We excluded acutely suicidal patients and those with psychosis, or with type I or type II bipolar disorder; patients whose low mood was associated with bereavement or whose primary presenting problem was alcohol or drug abuse; and patients receiving psychological treatment for their depression by specialist mental health services. We identified potentially eligible participants by searching computerised case records in general practices for patients with depression. Collaborative care, including depression education, drug management, behavioural activation, relapse prevention, and primary care liaison, was delivered by care managers. Collaborative care involved six to 12 contacts with participants over 14 weeks, supervised by mental health specialists. Usual care was family doctors' standard clinical practice. Depression symptoms (patient health questionnaire 9; PHQ-9), anxiety (generalised anxiety disorder 7; GAD-7), and quality of life (short form 36 questionnaire; SF-36) at four and 12 months; satisfaction with service quality (client satisfaction questionnaire; CSQ-8) at four months. 276 participants were allocated to collaborative care and 305 allocated to usual care. At four months, mean depression score was 11.1 (standard deviation 7.3) for the collaborative care group and 12.7 (6.8) for the usual care group. After adjustment for baseline depression, mean depression score was 1.33 PHQ-9 points lower (95% confidence interval 0.35 to 2.31, P=0.009) in participants receiving collaborative care than in those receiving usual

  19. 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.

    Science.gov (United States)

    Lindholt, J S; Gottschalksen, B; Johannesen, N; Dueholm, D; Ravn, H; Christensen, E D; Viddal, B; Flørenes, T; Pedersen, G; Rasmussen, M; Carstensen, M; Grøndal, N; Fasting, H

    2011-05-01

    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. Eleven Scandinavian centres enrolled 569 patients with chronic functional or critical lower limb ischaemia who were scheduled to undergo femoro-femoral bypass or femoro-poplitaeal bypass. The patients were randomised 1:1 stratified by centre. Patency was assessed by duplex ultrasound scanning. A total of 546 patients (96%) completed the study with adequate follow-up. Perioperative bleeding was, on average, 370 ml with PTFE grafts and 399 ml with Heparin-bonded PTFE grafts (p = 0.32). Overall, primary patency after 1 year was 86.4% for Hb-PTFE grafts and 79.9% for PTFE grafts (OR = 0.627, 95% CI: 0.398; 0.989, p = 0.043). Secondary patency was 88% in Hb-PTFE grafts and 81% in PTFE grafts (OR = 0.569 (0.353; 0.917, p = 0.020)). Subgroup analyses revealed that significant reduction in risk (50%) was observed when Hb-PTFE was used for femoro-poplitaeal bypass (OR = 0.515 (0.281; 0.944, p = 0.030)), and a significant reduction in risk (50%) was observed with Hb-PTFE in cases with critical ischaemia (OR = 0.490 (0.249; 0.962, p = 0.036)). The Hb-PTFE graft significantly reduced the overall risk of primary graft failure by 37%. Risk reduction was 50% in femoro-poplitaeal bypass cases and in cases with critical ischaemia. Copyright © 2011. Published by Elsevier Ltd.

  20. 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

  1. 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

  2. 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

  3. Cost-effectiveness of the Australian Medical Sheepskin for the prevention of pressure ulcers in somatic nursing home patients: study protocol for a prospective multi-centre randomised controlled trial (ISRCTN17553857

    Directory of Open Access Journals (Sweden)

    Montgomery Ken

    2008-01-01

    Full Text Available Abstract Background Pressure ulcers are a major problem, especially in nursing home patients, although they are regarded as preventable and there are many pressure relieving methods and materials. One such pressure relieving material is the recently developed Australian Medical Sheepskin, which has been shown in two randomized controlled trials 12 to be an effective intervention in the prevention of sacral pressure ulcers in hospital patients. However, the use of sheepskins has been debated and in general discouraged by most pressure ulcer working groups and pressure ulcer guidelines, but these debates were based on old forms of sheepskins. Furthermore, nothing is yet known about the (cost-effectiveness of the Australian Medical sheepskin in nursing home patients. The objective of this study is to assess the effects and costs of the use of the Australian Medical Sheepskin combined with usual care with regard to the prevention of sacral pressure ulcers in somatic nursing home patients, versus usual care only. Methods/Design In a multi-centre randomised controlled trial 750 patients admitted for a primarily somatic reason to one of the five participating nursing homes, and not having pressure ulcers on the sacrum at admission, will be randomized to either usual care only or usual care plus the use of the Australian Medical Sheepskin as an overlay on the mattress. Outcome measures are: incidence of sacral pressure ulcers in the first month after admission; sacrum pressure ulcer free days; costs; patient comfort; and ease of use. The skin of all the patients will be observed once a day from admission on for 30 days. Patient characteristics and pressure risk scores are assessed at admission and at day 30 after it. Additional to the empirical phase, systematic reviews will be performed in order to obtain data for economic weighting and modelling. The protocol is registered in the Controlled Trial Register as ISRCTN17553857.

  4. Cost-effectiveness of the Australian Medical Sheepskin for the prevention of pressure ulcers in somatic nursing home patients: study protocol for a prospective multi-centre randomised controlled trial (ISRCTN17553857).

    Science.gov (United States)

    Mistiaen, Patriek; Achterberg, Wilco; Ament, Andre; Halfens, Ruud; Huizinga, Janneke; Montgomery, Ken; Post, Henri; Francke, Anneke L

    2008-01-07

    Pressure ulcers are a major problem, especially in nursing home patients, although they are regarded as preventable and there are many pressure relieving methods and materials. One such pressure relieving material is the recently developed Australian Medical Sheepskin, which has been shown in two randomized controlled trials 12 to be an effective intervention in the prevention of sacral pressure ulcers in hospital patients. However, the use of sheepskins has been debated and in general discouraged by most pressure ulcer working groups and pressure ulcer guidelines, but these debates were based on old forms of sheepskins. Furthermore, nothing is yet known about the (cost-)effectiveness of the Australian Medical sheepskin in nursing home patients. The objective of this study is to assess the effects and costs of the use of the Australian Medical Sheepskin combined with usual care with regard to the prevention of sacral pressure ulcers in somatic nursing home patients, versus usual care only. In a multi-centre randomised controlled trial 750 patients admitted for a primarily somatic reason to one of the five participating nursing homes, and not having pressure ulcers on the sacrum at admission, will be randomized to either usual care only or usual care plus the use of the Australian Medical Sheepskin as an overlay on the mattress. Outcome measures are: incidence of sacral pressure ulcers in the first month after admission; sacrum pressure ulcer free days; costs; patient comfort; and ease of use. The skin of all the patients will be observed once a day from admission on for 30 days. Patient characteristics and pressure risk scores are assessed at admission and at day 30 after it. Additional to the empirical phase, systematic reviews will be performed in order to obtain data for economic weighting and modelling. The protocol is registered in the Controlled Trial Register as ISRCTN17553857.

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

    Directory of Open Access Journals (Sweden)

    Murphy Deirdre J

    2012-09-01

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

  6. A prospective randomised multi-centre study of the impact of Ga-68 PSMA-PET/CT imaging for staging high risk prostate cancer prior to curative-intent surgery or radiotherapy (proPSMA study): clinical trial protocol.

    Science.gov (United States)

    Hofman, Michael S; Murphy, Declan G; Williams, Scott G; Nzenza, Tatenda; Herschtal, Alan; De Abreu Lourenco, Richard; Bailey, Dale L; Budd, Ray; Hicks, Rodney J; Francis, Roslyn J; Lawrentschuk, Nathan

    2018-05-03

    Accurate staging of patients with prostate cancer is important for therapeutic decision making. Relapse following surgery or radiotherapy of curative intent is not uncommon and, in part, represents a failure of staging with current diagnostic imaging techniques to detect disease spread. Prostate-specific-membrane-antigen (PSMA) positron emission tomography / computed tomography (PET/CT) is a new whole body scanning technique that enables visualisation of prostate cancer with high contrast. The hypotheses of this study are that (a) PSMA-PET/CT has improved diagnostic performance compared to conventional imaging, (b) PSMA-PET/CT should be used as a first-line diagnostic test for staging, (c) the improved diagnostic performance of PSMA-PET/CT will result in significant management impact and (d) there are economic benefits if PSMA-PET/CT is incorporated into the management algorithm. This is a prospective, multi-centre study in which patients with untreated high-risk prostate cancer will be randomised to Gallium-68-PSMA11-PET/CT or conventional imaging, consisting of computer tomography of the abdomen/pelvis and bone scintigraphy with SPECT/CT. Inclusion criteria are newly diagnosed prostate cancer patients with select high-risk prostate cancer defined as International Society of Urological Pathology (ISUP) grade group ≥ 3 (primary Gleason grade 4, or any Gleason grade 5), PSA ≥ 20ng/mL or clinical stage ≥ T3. Patients with negative, equivocal or oligometastatic disease on first line-imaging will cross-over to receive the other imaging arm. The primary objective is to compare the accuracy of PSMA-PET/CT to conventional imaging for detecting nodal or distant metastatic disease. Histopathologic, imaging and clinical follow-up at six months will define the primary endpoint according to a pre-defined scoring system. Secondary objectives include comparing management impact, the number of equivocal studies, the incremental value of second-line imaging in patients who

  7. A multi-centre open-label randomised non-inferiority trial comparing watchful waiting to antibiotic treatment for acute otitis media without perforation in low-risk urban Aboriginal and Torres Strait Islander children (the WATCH trial): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Abbott, Penelope; Gunasekera, Hasantha; Leach, Amanda Jane; Askew, Deborah; Walsh, Robyn; Kong, Kelvin; Girosi, Federico; Bond, Chelsea; Morris, Peter; Lujic, Sanja; Hu, Wendy; Usherwood, Tim; Tyson, Sissy; Spurling, Geoffrey; Douglas, Markeeta; Schubert, Kira; Chapman, Shavaun; Siddiqui, Nadeem; Murray, Reeion; Rabbitt, Keitha; Porykali, Bobby; Woodall, Cheryl; Newman, Tina; Reath, Jennifer

    2016-03-03

    Treatment guidelines recommend watchful waiting for children older than 2 years with acute otitis media (AOM) without perforation, unless they are at high risk of complications. The high prevalence of chronic suppurative otitis media (CSOM) in remote Aboriginal and Torres Strait Islander communities leads these children to be classified as high risk. Urban Aboriginal and Torres Strait Islander children are at lower risk of complications, but evidence to support the subsequent recommendation for watchful waiting in this population is lacking. This non-inferiority multi-centre randomised controlled trial will determine whether watchful waiting is non-inferior to immediate antibiotics for urban Aboriginal and Torres Strait Islander children with AOM without perforation. Children aged 2 - 16 years with AOM who are considered at low risk for complications will be recruited from six participating urban primary health care services across Australia. We will obtain informed consent from each participant or their guardian. The primary outcome is clinical resolution on day 7 (no pain, no fever of at least 38 °C, no bulging eardrum and no complications of AOM such as perforation or mastoiditis) as assessed by general practitioners or nurse practitioners. Participants and outcome assessors will not be blinded to treatment. With a sample size of 198 children in each arm, we have 80 % power to detect a non-inferiority margin of up to 10 % at a significance level of 5 %, assuming clinical improvement of at least 80 % in both groups. Allowing for a 20 % dropout rate, we aim to recruit 495 children. We will analyse both by intention-to-treat and per protocol. We will assess the cost- effectiveness of watchful waiting compared to immediate antibiotic prescription. We will also report on the implementation of the trial from the perspectives of parents/carers, health professionals and researchers. The trial will provide evidence for the safety and effectiveness of watchful waiting

  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

    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...... 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...

  9. Scaphoid Waist Internal Fixation for Fractures Trial (SWIFFT) protocol: a pragmatic multi-centre randomised controlled trial of cast treatment versus surgical fixation for the treatment of bi-cortical, minimally displaced fractures of the scaphoid waist in adults.

    Science.gov (United States)

    Dias, Joseph; Brealey, Stephen; Choudhary, Surabhi; Cook, Liz; Costa, Matthew; Fairhurst, Caroline; Hewitt, Catherine; Hodgson, Stephen; Jefferson, Laura; Jeyapalan, Kanagaratnam; Keding, Ada; Leighton, Paul; Rangan, Amar; Richardson, Gerry; Rothery, Claire; Taub, Nicholas; Thompson, John; Torgerson, David

    2016-06-04

    A scaphoid fracture is the most common type of carpal fracture affecting young active people. The optimal management of this fracture is uncertain. When treated with a cast, 88 to 90 % of these fractures unite; however, for the remaining 10-12 % the non-union almost invariably leads to arthritis. The alternative is surgery to fix the scaphoid with a screw at the outset. We will conduct a randomised controlled trial (RCT) of 438 adult patients with a "clear" and "bicortical" scaphoid waist fracture on plain radiographs to evaluate the clinical effectiveness and cost-effectiveness of plaster cast treatment (with fixation of those that fail to unite) versus early surgical fixation. The plaster cast treatment will be immobilisation in a below elbow cast for 6 to 10 weeks followed by mobilisation. If non-union is confirmed on plain radiographs and/or Computerised Tomogram at 6 to 12 weeks, then urgent surgical fixation will be performed. This is being compared with immediate surgical fixation with surgeons using their preferred technique and implant. These treatments will be undertaken in trauma units across the United Kingdom. The primary outcome and end-point will be the Patient Rated Wrist Evaluation (a patient self-reported assessment of wrist pain and function) at 52 weeks and also measured at 6, 12, 26 weeks and 5 years. Secondary outcomes include an assessment of radiological union of the fracture; quality of life; recovery of wrist range and strength; and complications. We will also qualitatively investigate patient experiences of their treatment. Scaphoid fractures are an important public health problem as they predominantly affect young active individuals in the more productive working years of their lives. Non-union, if untreated, can lead to arthritis which can disable patients at a very young age. There is a rapidly increasing trend for immediate surgical fixation of these fractures but there is insufficient evidence from existing RCTs to support

  10. A prospective, multi-centre, randomised, open label, parallel, comparative study to evaluate effects of AQUACEL(®) Ag and Urgotul(®) Silver dressing on healing of chronic venous leg ulcers

    DEFF Research Database (Denmark)

    Harding, Keith; Gottrup, Finn; Jawień, Arkadiusz

    2011-01-01

    This study compared wound healing efficacy of two silver dressings, AQUACEL(®) Ag and Urgotul(®) Silver, against venous ulcers at risk of infection, over 8 weeks of treatment. The primary objective was to show non inferiority of AQUACEL(®) Ag to Urgotul(®) Silver. Patients (281) were randomised......, safety events and ulcer healing were compared. After 8 weeks of treatment, the AQUACEL(®) Ag group had a relative wound size reduction (49·65% ± 52·53%) compared with the Urgotul(®) Silver group (42·81% ± 60·0%). The non inferiority of the AQUACEL(®) Ag group to the Urgotul(®) Silver group...... was established based on the difference between them (6·84% ± 56·3%, 95% confidence interval -6·56 to 20·2) and the pre-defined non inferiority margin (-15%). Composite wound healing analysis showed that the AQUACEL(®) Ag group had statistically higher percentage of subjects with better wound progression (66...

  11. 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

    Directory of Open Access Journals (Sweden)

    Montgomery Alan A

    2009-08-01

    Full Text Available Abstract 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

  12. 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

    Science.gov (United States)

    Murphy, Deirdre J; Carey, Michael; Montgomery, Alan A; Sheehan, Sharon R

    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

  13. 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

  14. 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

  15. 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.

  16. Building a Multi-centre Clinical Research Facilitation Network: The ARC Experience

    Directory of Open Access Journals (Sweden)

    Ian Nicholson

    2017-06-01

    interest from general practitioner members but as yet no studies of general practice procedures have been forthcoming.Discussion: Vets want to be involved with clinical research. ARC has had early successes and will continue to grow - though more work is needed to encourage general practitioner members. Multi-centre research allows more cases to be recruited more quickly, adding weight to studies and shortening the period of data-gathering. These initial retrospective studies have generated a committed core of individuals seeking to create prospective studies together. An online tool is planned, to facilitate real-time case-recruitmentfor prospective multi-centre studies including randomised controlled trials. Anyone can join ARC, please email inicholsonvet@gmail.com.

  17. 46 CFR 310.11 - Cadet uniforms.

    Science.gov (United States)

    2010-10-01

    ... for State, Territorial or Regional Maritime Academies and Colleges § 310.11 Cadet uniforms. Cadet uniforms shall be supplied at the school in accordance with the uniform regulations of the School. Those... 46 Shipping 8 2010-10-01 2010-10-01 false Cadet uniforms. 310.11 Section 310.11 Shipping MARITIME...

  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 th...

  19. Authorship issues in multi-centre clinical trials

    DEFF Research Database (Denmark)

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

    2015-01-01

    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...... to the original source....

  20. Dosimetry audit for a multi-centre IMRT head and neck trial

    International Nuclear Information System (INIS)

    Clark, Catharine H.; Hansen, Vibeke Nordmark; Chantler, Hannah; Edwards, Craig; James, Hayley V.; Webster, Gareth; Miles, Elizabeth A.; Guerrero Urbano, M. Teresa; Bhide, Shree A.; Bidmead, A. Margaret; Nutting, Christoper M.

    2009-01-01

    Background and purpose: PARSPORT was a multi-centre randomised trial in the UK which compared Intensity-Modulated Radiotherapy (IMRT) and conventional radiotherapy (CRT) for patients with head and neck cancer. The dosimetry audit goals were to verify the plan delivery in participating centres, ascertain what tolerances were suitable for head and neck IMRT trials and develop an IMRT credentialing program. Materials and methods: Centres enrolling patients underwent rigorous quality assurance before joining the trial. Following this each centre was visited for a dosimetry audit, which consisted of treatment planning system tests, fluence verification films, combined field films and dose point measurements. Results: Mean dose point measurements were made at six centres. For the primary planning target volume (PTV) the differences with the planned values for the IMRT and CRT arms were -0.6% (1.8% to -2.4%) and 0.7% (2.0% to -0.9%), respectively. Ninety-four percent of the IMRT fluence films for individual fields passed gamma criterion of 3%/3 mm and 75% of the films for combined fields passed gamma criterion 4%/3 mm (no significant difference between dynamic delivery and step and shoot delivery). Conclusions: This audit suggests that a 3% tolerance could be applied for PTV point doses. For dose distributions tolerances of 3%/3 mm on individual fields and 4%/3 mm for combined fields are proposed for multi-centre head and neck IMRT trials.

  1. Recruiting ENT and Audiology patients into pharmaceutical trials: evaluating the multi-centre experience in the UK and USA.

    Science.gov (United States)

    Sanchez, Victoria A; Hall, Deborah A; Millar, Bonnie; Escabi, Celia D; Sharman, Alice; Watson, Jeannette; Thasma, Sornaraja; Harris, Peter

    2018-01-21

    Recruiting into clinical trials on time and on target is a major challenge and yet often goes unreported. This study evaluated the adjustment to procedures, recruitment and screening methods in two multi-centre pharmaceutical randomised controlled trials (RCTs) for hearing-related problems in adults. Recruitment monitoring and subsequent adjustment of various study procedures (e.g. eligibility criteria, increasing recruiting sites and recruitment methods) are reported. Participants were recruited through eight overarching methods: trial registration, posters/flyers, print publications, Internet, social media, radio, databases and referrals. The efficiency of the recruitment was measured by determining the number of people: (1) eligible for screening as a percentage of those who underwent telephone pre-screening and (2) randomised as a percentage of those screened. A total of 584 participants completed the pre-screening steps, 491 screened and 169 participants were randomised. Both RCTs completed adjustments to the participant eligibility, added new study sites and additional recruitment methods. No single recruitment method was efficient enough to serve as the only route to enrolment. A diverse portfolio of methods, continuous monitoring, mitigation strategy and adequate resourcing were essential for achieving our recruitment goals.

  2. Study Protocol: The Norfolk Diabetes Prevention Study [NDPS]: a 46 month multi - centre, randomised, controlled parallel group trial of a lifestyle intervention [with or without additional support from lay lifestyle mentors with Type 2 diabetes] to prevent transition to Type 2 diabetes in high risk groups with non - diabetic hyperglycaemia, or impaired fasting glucose.

    Science.gov (United States)

    Pascale, Melanie; Murray, Nikki; Bachmann, Max; Barton, Garry; Clark, Allan; Howe, Amanda; Greaves, Colin; Sampson, Mike

    2017-01-06

    This 7 year NIHR programme [2011-2018] tests the primary hypothesis that the NDPS diet and physical activity intervention will reduce the risk of transition to type 2 diabetes (T2DM) in groups at high risk of Type 2 diabetes. The NDPS programme recognizes the need to reduce intervention costs through group delivery and the use of lay mentors with T2DM, the realities of normal primary care, and the complexity of the current glycaemic categorisation of T2DM risk. NDPS identifies people at highest risk of T2DM on the databases of 135 general practices in the East of England for further screening with ab fasting plasma glucose and glycosylated haemoglobin [HbA1c]. Those with an elevated fasting plasma glucose [impaired fasting glucose or IFG] with or without an elevated HbA1c [non -diabetic hyperglycaemia; NDH] are randomised into three treatment arms: a control arm receiving no trial intervention, an arm receiving an intensive bespoke group-based diet and physical activity intervention, and an arm receiving the same intervention with enhanced support from people with T2DM trained as diabetes prevention mentors [DPM]. The primary end point is cumulative transition rates to T2DM between the two intervention groups, and between each intervention group and the control group at 46 months. Participants with screen detected T2DM are randomized into an equivalent prospective controlled trial with the same intervention and control arms with glycaemic control [HbA1c] at 46 months as the primary end point. Participants with NDH and a normal fasting plasma glucose are randomised into an equivalent prospective controlled intervention trial with follow up for 40 months. The intervention comprises six education sessions for the first 12 weeks and then up to 15 maintenance sessions until intervention end, all delivered in groups, with additional support from a DPM in one treatment arm. The NDPS programme reports in 2018 and will provide trial outcome data for a group delivered

  3. Cost-effectiveness of the mobile application TCApp combined with face-to-face CBT treatment compared to face-to-face CBT treatment alone for patients with an eating disorder: study protocol of a multi-centre randomised controlled trial.

    Science.gov (United States)

    Anastasiadou, Dimitra; Lupiañez-Villanueva, Francisco; Faulí, Clara; Arcal Cunillera, Jordina; Serrano-Troncoso, Eduardo

    2018-05-02

    The clinical utility of the existing apps for people with eating disorders (EDs) is not clear. The TCApp has been specifically developed for people with EDs, is based on the principles of Cognitive Behavioural Treatment (CBT) and allows a bidirectional link between the patient and the therapist. The objectives of the study are, first, to assess the clinical efficacy of a combined intervention for Eating Disorders (EDs) that includes an online intervention through the TCApp plus standard face-to-face CBT in comparison to standard face-to-face CBT alone, and second, to examine the cost-effectiveness of the TCApp and identify potential predicting, moderating and mediating variables that promote or hinder the implementation of the TCApp in ED units in Spain. The study methodology is that of a randomised controlled trial combining qualitative and quantitative methods, with a 6-month follow-up. Approximately 250 patients over 12 years old with a diagnosis of an ED from several ED units in Spain will be randomised to one of two different conditions. Participants, their caregivers, healthcare professionals and technical staff involved in the development and maintenance of the application will be assessed at baseline (T0), post-intervention (T1) and at 6 months follow-up (T2). Primary outcome measures will include ED symptomatology while secondary measures will include general psychopathology and quality of life for patients, quality of life and caregiving experience for family caregivers and adoption-related variables for all participants involved, such as perceived usability, user's satisfaction and technology acceptance. For the cost-effectiveness analysis, we will assess quality-adjusted life years (QALYs); total societal cost will be estimated using costs to patients and the health plan, and other related costs. The study will provide an important advance in the treatment of EDs; in the long term, it is expected to improve the quality of patient care and the treatment

  4. Development of Subjectivity in Cadets during Training

    Directory of Open Access Journals (Sweden)

    A S Markov

    2014-12-01

    Full Text Available The article submits the results of the research, where such personal factors as learning motivation, aggressive reactions and the choice of behavior strategy in conflict are considered as the indicators of subjectivity development. It also shows the dynamics of the subjectivity development in cadets on these indicators.

  5. 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

    patients, relatives and professional caregivers about patients' values and care preferences. It raises awareness of the need to anticipate possible future deterioration of health. ACP has the potential to improve current and future healthcare decision-making, provide patients with a sense of control......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...... Choices program from the perspectives of patients, their Personal Representatives, healthcare providers and facilitators. DISCUSSION: Transferring the concept of ACP from care of the elderly to patients with advanced cancer, who on average are younger and retain their mental capacity for a larger part...

  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

    patients, relatives and professional caregivers about patients' values and care preferences. It raises awareness of the need to anticipate possible future deterioration of health. ACP has the potential to improve current and future healthcare decision-making, provide patients with a sense of control...... Choices program from the perspectives of patients, their Personal Representatives, healthcare providers and facilitators. DISCUSSION: Transferring the concept of ACP from care of the elderly to patients with advanced cancer, who on average are younger and retain their mental capacity for a larger part...

  7. Authorship issues in multi-centre clinical trials: the importance of making an authorship contract.

    Science.gov (United States)

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

    2015-02-01

    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 to the original source.

  8. U.S. Naval Sea Cadet Corps 2009 Annual Report

    Science.gov (United States)

    2009-01-01

    for the Naval Sea Cadet Corps. I salute your service to our Nation in developing future leaders. Bravo Zulu and keep charging! ttr’"-- U.S...Minutemen, NLCC, sponsored by Channel Isles Council, NLUS, CA. The NSCC Hall of Fame Award: Awarded to a founder or volunteer U.S. Naval Sea Cadet

  9. 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...

  10. Evaluation of the preliminary auditory profile test battery in an international multi-centre study

    NARCIS (Netherlands)

    van Esch, T.E.M.; Kollmeier, B.; Vormann, M.; Lijzenga, J.; Houtgast, T.; Hallgren, M.; Larsby, B.; Athalye, S.P.; Lutman, M.E.; Dreschler, W.A.

    2013-01-01

    Objective: This paper describes the composition and international multi-centre evaluation of a battery of tests termed the preliminary auditory profile. It includes measures of loudness perception, listening effort, speech perception, spectral and temporal resolution, spatial hearing, self-reported

  11. Transvaginal prolapse repair with or without the addition of a midurethral sling in women with genital prolapse and stress urinary incontinence : a randomised trial

    NARCIS (Netherlands)

    van der Ploeg, J M; Oude Rengerink, K; van der Steen, A; van Leeuwen, J H S; Stekelenburg, J; Bongers, M Y; Weemhoff, M; Mol, B W; van der Vaart, C H; Roovers, J-P W R

    OBJECTIVE: To compare transvaginal prolapse repair combined with midurethral sling (MUS) versus prolapse repair only. DESIGN: Multi-centre randomised trial. SETTING: Fourteen teaching hospitals in the Netherlands. POPULATION: Women with symptomatic stage two or greater pelvic organ prolapse (POP),

  12. Ethical dilemmas of a large national multi-centre study in Australia: time for some consistency.

    Science.gov (United States)

    Driscoll, Andrea; Currey, Judy; Worrall-Carter, Linda; Stewart, Simon

    2008-08-01

    To examine the impact and obstacles that individual Institutional Research Ethics Committee (IRECs) had on a large-scale national multi-centre clinical audit called the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study. Multi-centre research is commonplace in the health care system. However, IRECs continue to fail to differentiate between research and quality audit projects. The National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes study used an investigator-developed questionnaire concerning a clinical audit for heart failure programmes throughout Australia. Ethical guidelines developed by the National governing body of health and medical research in Australia classified the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study as a low risk clinical audit not requiring ethical approval by IREC. Fifteen of 27 IRECs stipulated that the research proposal undergo full ethical review. None of the IRECs acknowledged: national quality assurance guidelines and recommendations nor ethics approval from other IRECs. Twelve of the 15 IRECs used different ethics application forms. Variability in the type of amendments was prolific. Lack of uniformity in ethical review processes resulted in a six- to eight-month delay in commencing the national study. Development of a national ethics application form with full ethical review by the first IREC and compulsory expedited review by subsequent IRECs would resolve issues raised in this paper. IRECs must change their ethics approval processes to one that enhances facilitation of multi-centre research which is now normative process for health services. The findings of this study highlight inconsistent ethical requirements between different IRECs. Also highlighted are the obstacles and delays that IRECs create when undertaking multi-centre clinical audits

  13. Sleep and Predicted Cognitive Performance of New Cadets during Cadet Basic Training at the United States Military Academy

    National Research Council Canada - National Science Library

    Miller, Daniel B

    2005-01-01

    .... The findings also indicate that the amount of sleep was not related to gender, race, cadet company assignment, age, recruited athlete status, or circadian chronotype (i.e., Morning/Evening preference).

  14. First-Year Cadets' Conceptions of General Education Writing at a Senior Military College

    Science.gov (United States)

    Rifenburg, J. Michael; Forester, Brian

    2018-01-01

    This study investigates conceptions first-year cadets at a US senior military college bring to general education writing courses, often termed first-year composition (FYC). Using a mixed methods research design, we received survey responses from 122 cadets and conducted semi-structured in-person interviews with four first-year cadets. Our data…

  15. 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.

  16. Functional fitness level of military college cadets

    Directory of Open Access Journals (Sweden)

    S.S. Fedak

    2016-12-01

    Full Text Available Purpose: to work out and study influence of author’s physical training program on functional fitness of military college officers. Material: in the research 83 3rd year cadets of military college participated (experimental group, n=41; control group, n=42, of age 19-21 years. The cadets’ functional state was registered by indicators of Shtange’s test, Genchi test, test of Ruffiet - Dixon, Cooper’s test. The volume of trainings was 4 hours a week. Results: it was found that the acting training programs do not permit to completely prepare combat soldier’s organism for fulfillment of his tasks. We also found the purposefulness of special exercises and means’ application in physical trainings, which would be approached by their structure to military officers’ professional actions. Conclusions: it is recommended to conduct training with complex combining of different physical training sections (accelerated motion, overcoming obstacle course, hand-to-hand fighting and etc. with special means ( armor vest, tactic unloading system, helmet, weapon, gas mask, training grenades and so on.

  17. Personality and social adjustment of medical cadets, Phramongkutklao College of Medicine.

    Science.gov (United States)

    Jaichumchuen, Tassana; Jarmornmarn, Sirinapa; Leelayoova, Saovanee; Mungthin, Mathirut

    2009-02-01

    To determine personality and ability of social adjustment of medical cadets, Phramongkutkao College of Medicine. In addition, the factors influencing social adjustment in these medical cadets were evaluated. The study population consisted of 45 medical cadets in their second year of a 6-year medical curriculum of Phramongkutkao College of Medicine. All study medical cadets gave written informed consent. The medical cadets completed a baseline assessment including a standardized questionnaire for general information and social adjustment. Personality traits were determined by a standard personality test, the 16 Personality Factor Questionnaire (16PF). The personalities of medical cadets were in between reserved and outgoing socially aware, concerns, shrewd and practical. The ability of social adjustment in these medical cadets was high. Social adjustment was significantly different between medical cadets who received different scholarships. Social adjustment of the medical cadets was positively correlated with personalities: factor C (emotionally stable), factor I (sensitivity), factor G (group conformity), factor H (social boldness), and factor Q3 (self-control), but negatively correlated with factor M (abstractedness), and factor Q2 (self-sufficiency). This study presents the unique personalities of medical cadets. Social adjustment is significantly different between medical cadets with different source of scholarships. Longitudinal study of the influence of personality and social adjustment on academic performance needs to be performed.

  18. 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

    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...... country-specific differences, differences in information available to the home assessor and the others and misunderstandings or difficulties in translation of information. To ensure the consistency of exposure assessments in international retrospective case-control studies it is important to have a well...

  19. The role of dosimetry audit in lung SBRT multi-centre clinical trials.

    Science.gov (United States)

    Clark, Catharine H; Hurkmans, Coen W; Kry, Stephen F

    2017-12-01

    Stereotactic Body Radiotherapy (SBRT) in the lung is a challenging technique which requires high quality clinical trials to answer the un-resolved clinical questions. Quality assurance of these clinical trials not only ensures the safety of the treatment of the participating patients but also minimises the variation in treatment, thus allowing the lowest number of patient treatments to answer the trial question. This review addresses the role of dosimetry audits in the quality assurance process and considers what can be done to ensure the highest accuracy of dose calculation and delivery and it's assessment in multi-centre trials. Copyright © 2017 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

  20. A multi-centre dosimetry audit on advanced radiotherapy in lung as part of the Isotoxic IMRT study

    Directory of Open Access Journals (Sweden)

    Yat Tsang

    2017-10-01

    Conclusion: This multi-centre dosimetry audit of complex IMRT/VMAT delivery provides confidence in the accuracy of modern planning and delivery systems in inhomogeneous tissues. The findings from this study can be used as a reference for future dosimetry audits.

  1. Coronary CT angiography using 64 detector rows: methods and design of the multi-centre trial CORE-64

    Energy Technology Data Exchange (ETDEWEB)

    Miller, Julie M.; Vavere, Andrea L.; Arbab-Zadeh, Armin; Bush, David E.; Lardo, Albert C.; Texter, John; Brinker, Jeffery; Lima, Joao A.C. [Johns Hopkins Hospital, Johns Hopkins University, Department of Medicine, Division of Cardiology, Baltimore, MD (United States); Dewey, Marc [Charite - Universitaetsmedizin Berlin, Medical School, Humboldt-Universitaet und Freie Universitaet zu Berlin, Department of Radiology, Berlin, PO Box 10098 (Germany); Rochitte, Carlos E.; Lemos, Pedro A. [University of Sao Paulo Medical School, Heart Institute (InCor), Sao Paulo (Brazil); Niinuma, Hiroyuki [Iwate Medical University, Department of Cardiology, Morioka (Japan); Paul, Narinder [Toronto General Hospital, Department of Medical Imaging, Toronto (Canada); Hoe, John [Medi-Rad Associates Ltd, CT Centre, Mt Elizabeth Hospital, Singapore (Singapore); Roos, Albert de [Leiden University Medical Center, Department of Radiology, Leiden (Netherlands); Yoshioka, Kunihiro [Iwate Medical University, Department of Radiology, Morioka (Japan); Cox, Christopher [Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology, Baltimore, MD (United States); Clouse, Melvin E. [Harvard University, Department of Radiology, Beth Israel Deaconess, Boston, MA (United States)

    2009-04-15

    Multislice computed tomography (MSCT) for the noninvasive detection of coronary artery stenoses is a promising candidate for widespread clinical application because of its non-invasive nature and high sensitivity and negative predictive value as found in several previous studies using 16 to 64 simultaneous detector rows. A multi-centre study of CT coronary angiography using 16 simultaneous detector rows has shown that 16-slice CT is limited by a high number of nondiagnostic cases and a high false-positive rate. A recent meta-analysis indicated a significant interaction between the size of the study sample and the diagnostic odds ratios suggestive of small study bias, highlighting the importance of evaluating MSCT using 64 simultaneous detector rows in a multi-centre approach with a larger sample size. In this manuscript we detail the objectives and methods of the prospective ''CORE-64'' trial (''Coronary Evaluation Using Multidetector Spiral Computed Tomography Angiography using 64 Detectors''). This multi-centre trial was unique in that it assessed the diagnostic performance of 64-slice CT coronary angiography in nine centres worldwide in comparison to conventional coronary angiography. In conclusion, the multi-centre, multi-institutional and multi-continental trial CORE-64 has great potential to ultimately assess the per-patient diagnostic performance of coronary CT angiography using 64 simultaneous detector rows. (orig.)

  2. 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.; Jutte, P.; Ploegmakers, J. J. W.; Stevens, M.

    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

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

    OpenAIRE

    Mohammed Nasser Alhuqbani

    2014-01-01

    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 in...

  4. Multi-port versus single-port cholecystectomy: results of a multi-centre, randomised controlled trial (MUSIC trial).

    Science.gov (United States)

    Arezzo, Alberto; Passera, Roberto; Bullano, Alberto; Mintz, Yoav; Kedar, Asaf; Boni, Luigi; Cassinotti, Elisa; Rosati, Riccardo; Fumagalli Romario, Uberto; Sorrentino, Mario; Brizzolari, Marco; Di Lorenzo, Nicola; Gaspari, Achille Lucio; Andreone, Dario; De Stefani, Elena; Navarra, Giuseppe; Lazzara, Salvatore; Degiuli, Maurizio; Shishin, Kirill; Khatkov, Igor; Kazakov, Ivan; Schrittwieser, Rudolf; Carus, Thomas; Corradi, Alessio; Sitzman, Guenther; Lacy, Antonio; Uranues, Selman; Szold, Amir; Morino, Mario

    2017-07-01

    Single-port laparoscopic surgery as an alternative to conventional laparoscopic cholecystectomy for benign disease has not yet been accepted as a standard procedure. The aim of the multi-port versus single-port cholecystectomy trial was to compare morbidity rates after single-access (SPC) and standard laparoscopy (MPC). This non-inferiority phase 3 trial was conducted at 20 hospital surgical departments in six countries. At each centre, patients were randomly assigned to undergo either SPC or MPC. The primary outcome was overall morbidity within 60 days after surgery. Analysis was by intention to treat. The study was registered with ClinicalTrials.gov (NCT01104727). The study was conducted between April 2011 and May 2015. A total of 600 patients were randomly assigned to receive either SPC (n = 297) or MPC (n = 303) and were eligible for data analysis. Postsurgical complications within 60 days were recorded in 13 patients (4.7 %) in the SPC group and in 16 (6.1 %) in the MPC group (P = 0.468); however, single-access procedures took longer [70 min (range 25-265) vs. 55 min (range 22-185); P risk of incisional hernia following SPC do not appear to be justified. Patient satisfaction with aesthetic results was greater after SPC than after MPC.

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

    OpenAIRE

    Freeman, Jennifer; Fox, Esther; Gear, Margaret; Hough, Alan

    2012-01-01

    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 bal...

  6. Advance care planning - a multi-centre cluster randomised clinical trial: The research protocol of the ACTION study

    NARCIS (Netherlands)

    J.A.C. Rietjens (Judith); I.J. Korfage (Ida); L. Dunleavy (Lesley); N.J. Preston (Nancy J.); L.J. Jabbarian (Lea J.); C.A. Christensen (Caroline Arnfeldt); M. de Brito (Maja); F. Bulli (Francesco); G. Caswell (Glenys); B. Červ (Branka); J.J.M. van Delden (Hans); L. Deliens (Luc); G. Gorini (Giuseppe); M. Groenvold (M.); D. Houttekier (Dirk); F. Ingravallo (Francesca); M.C. Kars (Marijke); U. Lunder (Urska); G. Miccinesi (Guido); A. Mimić (Alenka); E. Paci (Eugenio); S. Payne (S.); S. Polinder (Suzanne); K. Pollock (Kristian); J. Seymour (Jane); A. Simonič (Anja); A.T. Johnsen (Anna Thit); M.N. Verkissen (Mariëtte N.); E.G.E. de Vries (Elisabeth); A. Wilcock (Andrew); M. Zwakman (Marieke); A. van der Heide (Agnes)

    2016-01-01

    textabstractBackground: 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

  7. Advance care planning - a multi-centre cluster randomised clinical trial : The research protocol of the ACTION study

    NARCIS (Netherlands)

    Rietjens, Judith A C; Korfage, Ida J.; Dunleavy, Lesley; Preston, Nancy J.; Jabbarian, Lea J.; Christensen, Caroline Arnfeldt; de Brito, Maja; Bulli, Francesco; Caswell, Glenys; Červ, Branka; van Delden, Johannes; Deliens, Luc; Gorini, Giuseppe; Groenvold, Mogens; Houttekier, Dirk; Ingravallo, Francesca; Kars, Marijke C.; Lunder, Urška; Miccinesi, Guido; Mimić, Alenka; Paci, Eugenio; Payne, Sheila; Polinder, Suzanne; Pollock, Kristian; Seymour, Jane; Simonič, Anja; Johnsen, Anna Thit; Verkissen, Mariëtte N.; de Vries, Esther; Wilcock, Andrew; Zwakman, Marieke; van der Heide (Pl), Agnes

    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

  8. 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.

  9. 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. Copyright © 2010 John Wiley & Sons, Ltd.

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

    Science.gov (United States)

    Kjærgaard, Hanne; Olsen, Jørn; Ottesen, Bent; Nyberg, Per; Dykes, Anna-Karin

    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 nulliparous women in term spontaneous labour with a singleton infant in cephalic presentation. Data were collected by self-administered questionnaires and clinical data-records. Logistic regression analyses were used to estimate adjusted Odds Ratios (OR) and 95% confidence intervals (CI) are given. Results The following characteristics, present at admission to hospital, were associated with dystocia during labour (OR, 95% CI): dilatation of cervix dystocia. Conclusion Vaginal examinations at admission provide useful information on risk indicators for dystocia. The strongest risk indicator was use of epidural analgesia and if part of that is causal, it is of concern. PMID:18837972

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

    Directory of Open Access Journals (Sweden)

    Ottesen Bent

    2008-10-01

    Full Text Available Abstract 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 nulliparous women in term spontaneous labour with a singleton infant in cephalic presentation. Data were collected by self-administered questionnaires and clinical data-records. Logistic regression analyses were used to estimate adjusted Odds Ratios (OR and 95% confidence intervals (CI are given. Results The following characteristics, present at admission to hospital, were associated with dystocia during labour (OR, 95% CI: dilatation of cervix Conclusion Vaginal examinations at admission provide useful information on risk indicators for dystocia. The strongest risk indicator was use of epidural analgesia and if part of that is causal, it is of concern.

  12. Evidence - competence - discourse: the theoretical framework of the multi-centre clinical ethics support project METAP.

    Science.gov (United States)

    Reiter-Theil, Stella; Mertz, Marcel; Schürmann, Jan; Stingelin Giles, Nicola; Meyer-Zehnder, Barbara

    2011-09-01

    In this paper we assume that 'theory' is important for Clinical Ethics Support Services (CESS). We will argue that the underlying implicit theory should be reflected. Moreover, we suggest that the theoretical components on which any clinical ethics support (CES) relies should be explicitly articulated in order to enhance the quality of CES. A theoretical framework appropriate for CES will be necessarily complex and should include ethical (both descriptive and normative), metaethical and organizational components. The various forms of CES that exist in North-America and in Europe show their underlying theory more or less explicitly, with most of them referring to some kind of theoretical components including 'how-to' questions (methodology), organizational issues (implementation), problem analysis (phenomenology or typology of problems), and related ethical issues such as end-of-life decisions (major ethical topics). In order to illustrate and explain the theoretical framework that we are suggesting for our own CES project METAP, we will outline this project which has been established in a multi-centre context in several healthcare institutions. We conceptualize three 'pillars' as the major components of our theoretical framework: (1) evidence, (2) competence, and (3) discourse. As a whole, the framework is aimed at developing a foundation of our CES project METAP. We conclude that this specific integration of theoretical components is a promising model for the fruitful further development of CES. © 2011 Blackwell Publishing Ltd.

  13. Prevalence of maternal anaemia and its predictors: a multi-centre study.

    Science.gov (United States)

    Barroso, Filipa; Allard, Shubha; Kahan, Brennan C; Connolly, Catriona; Smethurst, Heather; Choo, Louise; Khan, Khalid; Stanworth, Simon

    2011-11-01

    To investigate the prevalence, predictors, and management of anaemia in pregnancy. A multi centre study across 11 maternity units in the UK. Data were collected over a two week study period in 2008 on maternal history, haemoglobin (Hb) and ferritin concentrations, iron therapy during pregnancy and in the postpartum period. Logistic regression models were used to explore factors associated with anaemia during pregnancy. Main outcomes included anaemia, defined as Hbanaemia by 32 weeks gestation included young maternal age (odds ratio 1.96, 95% CI 1.38-2.79), non-white ethnic origin (odds ratios varied 1.37-2.89 depending on ethnic origin) and increasing parity (odds ratio 1.24, 95% CI 1.08-1.41). Of women who had postnatal Hb levels checked, 30% (309/1031) were anaemic and, depending on centre, 16% to 86% of these received iron therapy. Anaemia was reported in nearly one in four women in the antenatal period, and nearly one in three of the women who had a postpartum Hb checked. Despite national guidelines, there was considerable variation in administration of iron including low utilisation of parenteral iron therapy. Future research needs to focus on the consequences of iron deficiency anaemia for maternal and infant health outcomes and effectiveness of implementation strategies to reduce anaemia. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  14. Cognitive Evaluation of Israeli Air Force Pilot Cadets.

    Science.gov (United States)

    Gordon, Shirley; Goren, Chen; Carmon, Erez; Shelef, Leah

    2017-04-01

    In aviation psychology, there is a constant need for the cognitive evaluation of pilots as part of operational fitness and safety criteria. A cross-sectional study with comparison between the performance of Israeli Air Force pilot cadets (N = 318) and U.S. Air Force pilot training candidates (N = 512) as assessed by a cognitive battery was undertaken. The data of the comparison group was collected from Callister, King, and Retzlaff, as published in 1996. In general, the means in the three components composing the battery-speed, accuracy, and throughput variables-indicated that the Israeli Air Force pilot cadets' scores were higher than those of the U.S. Air Force pilot candidates' scores in 50 of 53 variables. Nonsignificant differences were found in Accuracy of shifting attention-arrow color (SATAC), pathfinder-combined (PFC), and pathfinder-letter (PFL). The difference in performance between the two groups may be due to differences in population characteristics. However, these results need to be considered cautiously, as the groups were sampled at a sizeable time gap (1996 for the U.S. Air Force vs. 2013 for the Israeli Air Force), with each time period characterized by different cultural and technological influences.Gordon S, Goren C, Carmon E, Shelef L. Cognitive evaluation of Israeli Air Force pilot cadets. Aerosp Med Hum Perform. 2017; 88(4):392-398.

  15. Development of a Multi-Centre Clinical Trial Data Archiving and Analysis Platform for Functional Imaging

    Science.gov (United States)

    Driscoll, Brandon; Jaffray, David; Coolens, Catherine

    2014-03-01

    Purpose: To provide clinicians & researchers participating in multi-centre clinical trials with a central repository for large volume dynamic imaging data as well as a set of tools for providing end-to-end testing and image analysis standards of practice. Methods: There are three main pieces to the data archiving and analysis system; the PACS server, the data analysis computer(s) and the high-speed networks that connect them. Each clinical trial is anonymized using a customizable anonymizer and is stored on a PACS only accessible by AE title access control. The remote analysis station consists of a single virtual machine per trial running on a powerful PC supporting multiple simultaneous instances. Imaging data management and analysis is performed within ClearCanvas Workstation® using custom designed plug-ins for kinetic modelling (The DCE-Tool®), quality assurance (The DCE-QA Tool) and RECIST. Results: A framework has been set up currently serving seven clinical trials spanning five hospitals with three more trials to be added over the next six months. After initial rapid image transfer (+ 2 MB/s), all data analysis is done server side making it robust and rapid. This has provided the ability to perform computationally expensive operations such as voxel-wise kinetic modelling on very large data archives (+20 GB/50k images/patient) remotely with minimal end-user hardware. Conclusions: This system is currently in its proof of concept stage but has been used successfully to send and analyze data from remote hospitals. Next steps will involve scaling up the system with a more powerful PACS and multiple high powered analysis machines as well as adding real-time review capabilities.

  16. A multi-centre clinical evaluation of reactive oxygen topical wound gel in 114 wounds.

    Science.gov (United States)

    Dryden, M; Dickinson, A; Brooks, J; Hudgell, L; Saeed, K; Cutting, K F

    2016-03-01

    This article reports the outcomes of the use of Surgihoney RO (SHRO), topical wound dressing in a multi-centre, international setting. The aims were to explore the clinical effects of SHRO, including a reduction in bacterial load and biofilm and improvement in healing in a variety of challenging non-healing and clinically infected wounds. This was a non-comparative evaluation, where both acute and chronic wounds with established delayed healing were treated with the dressing. Clinicians prospectively recorded wound improvement or deterioration, level of wound exudate, presence of pain, and presence of slough and necrosis. Analysis of this data provided information on clinical performance of the dressing. Semi-quantitative culture to assess bacterial bioburden was performed where possible. We recruited 104 patients, mean age 61 years old, with 114 wounds. The mean duration of wounds before treatment was 3.7 months and the mean duration of treatment was 25.7 days. During treatment 24 wounds (21%) healed and the remaining 90 (79%) wounds improved following application of the dressing. No deterioration in any wound was observed. A reduction in patient pain, level of wound exudate and in devitalised tissue were consistently reported. These positive improvements in wound progress were reflected in the wound cultures that showed a reduction in bacterial load in 39 out of the 40 swabs taken. There were two adverse events recorded: a stinging sensation following application of the dressing was experienced by 2 patients, and 2 elderly patients died of causes unrelated to the dressing or to the chronic wound. These patients' wounds and their response to SHRO have been included in the analysis. SHRO was well tolerated and shows great promise as an effective potent topical antimicrobial in the healing of challenging wounds. Matthew Dryden has become a shareholder in Matoke Holdings, the manufacturer of Surgihoney RO, since the completion of this study. Keith Cutting is a

  17. Multi-centre audit of VMAT planning and pre-treatment verification.

    Science.gov (United States)

    Jurado-Bruggeman, Diego; Hernández, Victor; Sáez, Jordi; Navarro, David; Pino, Francisco; Martínez, Tatiana; Alayrach, Maria-Elena; Ailleres, Norbert; Melero, Alejandro; Jornet, Núria

    2017-08-01

    We performed a multi-centre intercomparison of VMAT dose planning and pre-treatment verification. The aims were to analyse the dose plans in terms of dosimetric quality and deliverability, and to validate whether in-house pre-treatment verification results agreed with those of an external audit. The nine participating centres encompassed different machines, equipment, and methodologies. Two mock cases (prostate and head and neck) were planned using one and two arcs. A plan quality index was defined to compare the plans and different complexity indices were calculated to check their deliverability. We compared gamma index pass rates using the centre's equipment and methodology to those of an external audit (global 3D gamma, absolute dose differences, 10% of maximum dose threshold). Log-file analysis was performed to look for delivery errors. All centres fulfilled the dosimetric goals but plan quality and delivery complexity were heterogeneous and uncorrelated, depending on the manufacturer and the planner's methodology. Pre-treatment verifications results were within tolerance in all cases for gamma 3%-3mm evaluation. Nevertheless, differences between the external audit and in-house measurements arose due to different equipment or methodology, especially for 2%-2mm criteria with differences up to 20%. No correlation was found between complexity indices and verification results amongst centres. All plans fulfilled dosimetric constraints, but plan quality and complexity did not correlate and were strongly dependent on the planner and the vendor. In-house measurements cannot completely replace external audits for credentialing. Copyright © 2017 Elsevier B.V. All rights reserved.

  18. Development of a Multi-Centre Clinical Trial Data Archiving and Analysis Platform for Functional Imaging

    International Nuclear Information System (INIS)

    Driscoll, Brandon; Jaffray, David; Coolens, Catherine

    2014-01-01

    Purpose: To provide clinicians and researchers participating in multi-centre clinical trials with a central repository for large volume dynamic imaging data as well as a set of tools for providing end-to-end testing and image analysis standards of practice. Methods: There are three main pieces to the data archiving and analysis system; the PACS server, the data analysis computer(s) and the high-speed networks that connect them. Each clinical trial is anonymized using a customizable anonymizer and is stored on a PACS only accessible by AE title access control. The remote analysis station consists of a single virtual machine per trial running on a powerful PC supporting multiple simultaneous instances. Imaging data management and analysis is performed within ClearCanvas Workstation® using custom designed plug-ins for kinetic modelling (The DCE-Tool®), quality assurance (The DCE-QA Tool) and RECIST. Results: A framework has been set up currently serving seven clinical trials spanning five hospitals with three more trials to be added over the next six months. After initial rapid image transfer (+ 2 MB/s), all data analysis is done server side making it robust and rapid. This has provided the ability to perform computationally expensive operations such as voxel-wise kinetic modelling on very large data archives (+20 GB/50k images/patient) remotely with minimal end-user hardware. Conclusions: This system is currently in its proof of concept stage but has been used successfully to send and analyze data from remote hospitals. Next steps will involve scaling up the system with a more powerful PACS and multiple high powered analysis machines as well as adding real-time review capabilities.

  19. Multi-centre evaluation of recent troponin assays for the diagnosis of NSTEMI

    Directory of Open Access Journals (Sweden)

    Camille Chenevier-Gobeaux

    2018-07-01

    Full Text Available Objectives: We aimed to compare the use of nine different cardiac troponin (cTn assays (2 cTnT and 7 cTnI for the diagnosis of NSTEMI in a single multi-centre population. Design and methods: One hundred and fifty-eight patients were included (mean age 60 years, SD 17 years, including 23 patients (14% with NSTEMI. Results: The analytical comparison highlighted a large heterogeneity of cTn assays, as reflected by percentages of patients with detectable cTn, correlation coefficients, Passing-Bablok comparisons and concordance coefficients. Correlations within cTnI assays were good and correlation within cTnT assays was excellent. Diagnostic performances demonstrated that each cTn assay has specific threshold values. Furthermore, some assays (HS-cTnI and T, cTnI-Pathfast and cTnI-Centaur indicated high sensitivity and negative predictive value using the limit of detection (LoD diagnostic strategy. For the latter assays, a significant increase in specificity was found when using the 99th percentile or the H0-H3 strategies, in comparison to the LoD strategy. When applying the European Society of Cardiology H0-H3 algorithm, comparable diagnostic performances were obtained. Conclusion: All 9 cTn assays indicated overall good diagnostic performances for the diagnosis of NSTEMI in emergency departments when the recommended algorithm based on the variation of cTn value between two measurements at admission and 3 h later was used. Keywords: Cardiac troponin, High-sensitivity assay, Chest pain, Emergency department, NSTEMI, Analytical evaluation

  20. Multi-centre evaluation of mass spectrometric identification of anaerobic bacteria using the VITEK® MS system.

    Science.gov (United States)

    Garner, O; Mochon, A; Branda, J; Burnham, C-A; Bythrow, M; Ferraro, M; Ginocchio, C; Jennemann, R; Manji, R; Procop, G W; Richter, S; Rychert, J; Sercia, L; Westblade, L; Lewinski, M

    2014-04-01

    Accurate and timely identification of anaerobic bacteria is critical to successful treatment. Classic phenotypic methods for identification require long turnaround times and can exhibit poor species level identification. Matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS) is an identification method that can provide rapid identification of anaerobes. We present a multi-centre study assessing the clinical performance of the VITEK(®) MS in the identification of anaerobic bacteria. Five different test sites analysed a collection of 651 unique anaerobic isolates comprising 11 different genera. Multiple species were included for several of the genera. Briefly, anaerobic isolates were applied directly to a well of a target plate. Matrix solution (α-cyano-4-hydroxycinnamic acid) was added and allowed to dry. Mass spectra results were generated with the VITEK(®) MS, and the comparative spectral analysis and organism identification were determined using the VITEK(®) MS database 2.0. Results were confirmed by 16S rRNA gene sequencing. Of the 651 isolates analysed, 91.2% (594/651) exhibited the correct species identification. An additional eight isolates were correctly identified to genus level, raising the rate of identification to 92.5%. Genus-level identification consisted of Actinomyces, Bacteroides and Prevotella species. Fusobacterium nucleatum, Actinomyces neuii and Bacteroides uniformis were notable for an increased percentage of no-identification results compared with the other anaerobes tested. VITEK(®) MS identification of clinically relevant anaerobes is highly accurate and represents a dramatic improvement over other phenotypic methods in accuracy and turnaround time. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

  1. Multi-centre diagnostic classification of individual structural neuroimaging scans from patients with major depressive disorder.

    Science.gov (United States)

    Mwangi, Benson; Ebmeier, Klaus P; Matthews, Keith; Steele, J Douglas

    2012-05-01

    Quantitative abnormalities of brain structure in patients with major depressive disorder have been reported at a group level for decades. However, these structural differences appear subtle in comparison with conventional radiologically defined abnormalities, with considerable inter-subject variability. Consequently, it has not been possible to readily identify scans from patients with major depressive disorder at an individual level. Recently, machine learning techniques such as relevance vector machines and support vector machines have been applied to predictive classification of individual scans with variable success. Here we describe a novel hybrid method, which combines machine learning with feature selection and characterization, with the latter aimed at maximizing the accuracy of machine learning prediction. The method was tested using a multi-centre dataset of T(1)-weighted 'structural' scans. A total of 62 patients with major depressive disorder and matched controls were recruited from referred secondary care clinical populations in Aberdeen and Edinburgh, UK. The generalization ability and predictive accuracy of the classifiers was tested using data left out of the training process. High prediction accuracy was achieved (~90%). While feature selection was important for maximizing high predictive accuracy with machine learning, feature characterization contributed only a modest improvement to relevance vector machine-based prediction (~5%). Notably, while the only information provided for training the classifiers was T(1)-weighted scans plus a categorical label (major depressive disorder versus controls), both relevance vector machine and support vector machine 'weighting factors' (used for making predictions) correlated strongly with subjective ratings of illness severity. These results indicate that machine learning techniques have the potential to inform clinical practice and research, as they can make accurate predictions about brain scan data from

  2. The Effects of Higher Education/Military Service on Achievement Levels of Police Academy Cadets.

    Science.gov (United States)

    Johnson, Thomas Allen

    This study compared levels of achievement of three groups of Houston (Texas) police academy cadets: those with no military service but with 60 or more college credit hours, those with military service and 0 hours of college credit, and those with military service and 1 to 59 hours of college credit. Prior to 1991, police cadets in Houston were…

  3. Military and Civilian L2 Instructors: Decoding Perceptions of U.S. Service Academy Cadets

    Science.gov (United States)

    Miller, Zachary F.

    2016-01-01

    This study examined whether cadets at a U.S. service academy perceived attitudinal differences toward their military and civilian L2 instructors along three variables: foreign language expertise, communicative anxiety, and relatability. Cadets' proficiency levels (divided by beginning and intermediate classes) and current instructor (civilian or…

  4. Associations between community-based physiotherapy for musculoskeletal injury and health related quality of life (EQ-5D): a multi-centre retrospective analysis.

    Science.gov (United States)

    Caplan, Nick; Robson, H; Robson, A; Barry, G; Wilkes, G

    2017-10-25

    Community-based musculoskeletal physiotherapy is used to improve function and health related quality of life (HRQoL). The purpose of this retrospective, multi-centre observational study was to determine the association between community-based physiotherapy management for musculoskeletal disorders and changes in HRQoL. Four thousand one hundred twelve patients' data were included in the study. Patients were included if they received a single period of treatment for a musculoskeletal injury or disorder. Patients were only included if they were being treated for a single morbidity. Patients received standard physiotherapy appropriate to their specific disorder, which could include health education/advice, exercise therapy, manual therapy, taping, soft tissue techniques, electrotherapy and/or acupuncture. Health related quality of life was assessed using the EQ-5D index. EQ-5D improved by 0.203 across all patients (d = 1.10). When grouped by anatomical site of symptom, the largest increases in EQ-5D was in foot pain (0.233; d = 1.29) and lumbar pain (0.231; d = 1.13). Improvements in EQ-5D greater than the minimum clinically important difference (MCID) were seen in 68.4% of all patients. The highest proportion of patients with positive responses to treatment were in ankle pain (74.2%) and thoracic pain (73.4%). The hand (40.5%), elbow (34.7%), and hip (33.9%) showed the greatest proportion of patients that did not respond to treatment. Community-based musculoskeletal physiotherapy is associated with improved health related quality of life. A randomised controlled trial is needed to determine any causal relationship between community-based physiotherapy and health related quality of life improvements.

  5. Vorinostat in refractory soft tissue sarcomas - Results of a multi-centre phase II trial of the German Soft Tissue Sarcoma and Bone Tumour Working Group (AIO).

    Science.gov (United States)

    Schmitt, Thomas; Mayer-Steinacker, Regine; Mayer, Frank; Grünwald, Viktor; Schütte, Jochen; Hartmann, Jörg T; Kasper, Bernd; Hüsing, Johannes; Hajda, Jacek; Ottawa, Gregor; Mechtersheimer, Gunhild; Mikus, Gerd; Burhenne, Jürgen; Lehmann, Lorenz; Heilig, Christoph E; Ho, Anthony D; Egerer, Gerlinde

    2016-09-01

    New treatment options for patients with metastatic Soft Tissue Sarcoma are urgently needed. Preclinical studies suggested activity of vorinostat, a histone deacetylase inhibitor. A multi-centre, open-label, non-randomised phase II trial to investigate the efficacy and safety of vorinostat in patients with locally advanced or metastatic Soft Tissue Sarcoma failing 1st-line anthracycline-based chemotherapy was initiated. Patients were treated with vorinostat 400 mg po qd for 28 d followed by a treatment-free period of 7 d, representing a treatment cycle of 5 weeks. Restaging was performed every three cycles or at clinical progression. Between 06/10 and 09/13, 40 Soft Tissue Sarcoma patients were treated with vorinostat at seven participating centres. Patients had received 1 (n=8, 20%), 2 (n=10, 25%) or ≥3 (n=22, 55%) previous lines of chemotherapy. Best response after three cycles of treatment was stable disease (n=9, 23%). Median progression-free survival and overall survival were 3.2 and 12.3 months, respectively. Six patients showed long-lasting disease stabilisation for up to ten cycles. Statistical analyses failed to identify baseline predictive markers in this subgroup. Major toxicities (grade ≥III) included haematological toxicity (n=6, 15%) gastrointestinal disorders (n=5, 13%), fatigue (n=4, 10%), musculoskeletal pain (n=4, 10%), and pneumonia (n=2, 5%). In a heavily pre-treated patient population, objective response to vorinostat was low. However, a small subgroup of patients had long-lasting disease stabilisation. Further studies aiming to identify predictive markers for treatment response as well as exploration of combination regimens are warranted. NCT00918489 (ClinicalTrials.gov) EudraCT-number: 2008-008513-19. Copyright © 2016 Elsevier Ltd. All rights reserved.

  6. MULTICULTURAL EDUCATION AND ITS IMPACT ON LANGUAGE DEVELOPMENT: THE CASE OF MILITARY CADETS AT TMA

    Directory of Open Access Journals (Sweden)

    Hakan Hilmi Demirel

    2016-04-01

    Full Text Available The purpose of the study was three-fold: First, to determine the perspectives of the international and Turkish military cadets at Turkish Military Academy (TMA towards multicultural learning environment and cultural diversity. Second, to analyze to what extent the multicultural learning environment affects the language development of both international and Turkish cadets. Third, to identify the observations and suggestions of language instructors about the best practices that should be applied in multicultural learning setting. A questionnaire and two proficiency tests were conducted on 80 cadets for quantitative data. Qualitative data was gathered from 13 language instructors studying at TMA. It was found that the perspectives of the cadets towards multicultural learning setting were positive. Moreover, the international cadets’ language proficiency developed more than the Turkish cadets. Analysis of the interviews with the language instructors provided important insights into the issue.

  7. Conservative treatment of a mandibular condyle fracture: comparing intermaxillary fixation with screws or arch bar. A randomised clinical trial

    NARCIS (Netherlands)

    van den Bergh, B.; Blankestijn, J.; van der Ploeg, T.; Tuinzing, D.B.; Forouzanfar, T.

    2015-01-01

    Introduction A mandibular condyle fracture can be treated conservatively by intermaxillary fixation (IMF) or by open reposition and internal fixation (ORIF). Many IMF-modalities can be chosen, including IMF-screws (IMFS). This prospective multi-centre randomised clinical trial compared the use of

  8. Conservative treatment of a mandibular condyle fracture: Comparing intermaxillary fixation with screws or arch bar. A randomised clinical trial

    NARCIS (Netherlands)

    van den Bergh, B.; Blankestijn, J.; van der Ploeg, T.; Tuinzing, D.B.; Forouzanfar, T.

    2015-01-01

    Introduction A mandibular condyle fracture can be treated conservatively by intermaxillary fixation (IMF) or by open reposition and internal fixation (ORIF). Many IMF-modalities can be chosen, including IMF-screws (IMFS). This prospective multi-centre randomised clinical trial compared the use of

  9. Understanding help-seeking intentions in male military cadets: An application of perceptual mapping.

    Science.gov (United States)

    Bass, Sarah Bauerle; Muñiz, Javier; Gordon, Thomas F; Maurer, Laurie; Patterson, Freda

    2016-05-17

    Research suggests that men are less likely to seek help for depression, substance abuse, and stressful life events due to negative perceptions of asking for and receiving help. This may be exacerbated in male military cadets who exhibit higher levels of gender role conflict because of military culture. This exploratory study examined the perceptions of 78 male military cadets toward help-seeking behaviors. Cadets completed the 31-item Barriers to Help Seeking Scale (BHSS) and a component factor analysis was used to generate five composite variables and compare to validated factors. Perceptual mapping and vector modeling, which produce 3-dimensional models of a group's perceptions, were then used to model how they conceptualize help-seeking. Factor analysis showed slightly different groupings than the BHSS, perhaps attributed to different characteristics of respondents, who are situated in a military school compared to general university males. Perceptual maps show that cadets perceive trust of doctors closest to them and help-seeking farthest, supporting the concept that these males have rigid beliefs about having control and its relationship to health seeking. Differences were seen when comparing maps of White and non-White cadets. White cadets positioned themselves far away from all variables, while non-White cadets were closest to "emotional control". To move these cadets toward help-seeking, vector modeling suggests that interventions should focus on their general trust of doctors, accepting lack of control, and decreasing feelings of weakness when asking for help. For non-White cadets a focus on self-reliance may also need to be emphasized. Use of these unique methods resulted in articulation of specific barriers that if addressed early, may have lasting effects on help-seeking behavior as these young men become adults. Future studies are needed to develop and test specific interventions to promote help-seeking among military cadets.

  10. Understanding help-seeking intentions in male military cadets: An application of perceptual mapping

    Directory of Open Access Journals (Sweden)

    Sarah Bauerle Bass

    2016-05-01

    Full Text Available Abstract Background Research suggests that men are less likely to seek help for depression, substance abuse, and stressful life events due to negative perceptions of asking for and receiving help. This may be exacerbated in male military cadets who exhibit higher levels of gender role conflict because of military culture. Methods This exploratory study examined the perceptions of 78 male military cadets toward help-seeking behaviors. Cadets completed the 31-item Barriers to Help Seeking Scale (BHSS and a component factor analysis was used to generate five composite variables and compare to validated factors. Perceptual mapping and vector modeling, which produce 3-dimensional models of a group’s perceptions, were then used to model how they conceptualize help-seeking. Results Factor analysis showed slightly different groupings than the BHSS, perhaps attributed to different characteristics of respondents, who are situated in a military school compared to general university males. Perceptual maps show that cadets perceive trust of doctors closest to them and help-seeking farthest, supporting the concept that these males have rigid beliefs about having control and its relationship to health seeking. Differences were seen when comparing maps of White and non-White cadets. White cadets positioned themselves far away from all variables, while non-White cadets were closest to “emotional control”. Conclusion To move these cadets toward help-seeking, vector modeling suggests that interventions should focus on their general trust of doctors, accepting lack of control, and decreasing feelings of weakness when asking for help. For non-White cadets a focus on self-reliance may also need to be emphasized. Use of these unique methods resulted in articulation of specific barriers that if addressed early, may have lasting effects on help-seeking behavior as these young men become adults. Future studies are needed to develop and test specific interventions

  11. AEROBIC POWER IN CHILD, CADET AND SENIOR JUDO ATHLETES

    Directory of Open Access Journals (Sweden)

    Elena Pocecco

    2012-07-01

    Full Text Available The aim of the present study was to compare performance and physiological responses during arm and leg aerobic power tests of combat duration in male child, cadet and senior judo athletes. Power output and physiological parameters, i.e., peak oxygen uptake ( ·VO2peak, peak ventilation, peak heart rate, lactate, and rate of perceived exertion, of 7 child (under 15 years: age class U15, 12.7 ± 1.1 yrs, 10 cadet (U17, 14.9 ± 0.7 yrs and 8 senior ( 20, 29.3 ± 9.2 yrs male judo athletes were assessed during incremental tests of combat duration on an arm crank and a cycle ergometer. Children as well as cadets demonstrated higher upper body relative VO2peak than seniors (37.3 ± 4.9, 39.2 ± 5.0 and 31.0 ± 2.1 ml∙kg-1∙min-1, respectively; moreover, upper and lower body relative VO2peak decreased with increasing age (r = -0.575, p < 0.003 and r = -0.580, p < 0.002, respectively. Children showed lower blood lactate concentrations after cranking as well as after cycling when compared to seniors (7.8 ± 2.4 vs. 11.4 ± 2.1 mmol∙l-1 and 7.9 ± 3.0 vs. 12.0 ± 1.9 mmol���l-1, respectively; furthermore, blood lactate values after cranking increased with age (r = 0.473, p < 0.017. These differences should be considered in planning the training for judo athletes of different age classes.

  12. A multi-centre evaluation of oral cancer in Southern and Western Nigeria: an African oral pathology research consortium initiative.

    Science.gov (United States)

    Omitola, Olufemi Gbenga; Soyele, Olujide Oladele; Sigbeku, Opeyemi; Okoh, Dickson; Akinshipo, Abdulwarith Olaitan; Butali, Azeez; Adeola, Henry Ademola

    2017-01-01

    Oral cancer is a leading cause of cancer deaths among African populations. Lack of standard cancer registries and under-reporting has inaccurately depicted its magnitude in Nigeria. Development of multi-centre collaborative oral pathology networks such as the African Oral Pathology Research Consortium (AOPRC) facilitates skill and expertise exchange and fosters a robust and systematic investigation of oral diseases across Africa. In this descriptive cross-sectional study, we have leveraged the auspices of the AOPRC to examine the burden of oral cancer in Nigeria, using a multi-centre approach. Data from 4 major tertiary health institutions in Western and Southern Nigeria was generated using a standardized data extraction format and analysed using the SPSS data analysis software (version 20.0; SPSS Inc. Chicago, IL). Of the 162 cases examined across the 4 centres, we observed that oral squamous cell carcinomas (OSCC) occurred mostly in the 6 th and 7 th decades of life and maxillary were more frequent than mandibular OSCC lesions. Regional variations were observed both for location, age group and gender distribution. Significant regional differences was found between poorly, moderately and well differentiated OSCC (p value = 0.0071). A multi-centre collaborative oral pathology research approach is an effective way to achieve better insight into the patterns and distribution of various oral diseases in men of African descent. The wider outlook for AOPRC is to employ similar approaches to drive intensive oral pathology research targeted at addressing the current morbidity and mortality of various oral diseases across Africa.

  13. Fast neutrons in the treatment of head and neck cancers: the results of a multi-centre randomly controlled trial

    International Nuclear Information System (INIS)

    Duncan, W.; Arnott, S.J.; Orr, J.A.; Kerr, G.R.; Schmitt, G.

    1984-01-01

    The results are presented of a multi-centre randomly controlled trial of fast neutron irradiation and mega-voltage X-rays in the treatment of patients with locally advanced squamous cell carcinoma of the head and neck region. No significant difference was observed in local tumour control rates. Salvage surgery was performed in a similar number of patients in the two groups. Late morbidity was also similar in the two treatment groups. Patients in a subgroup with cancer of the larynx treated by photons had a significantly better survival than those in the neutron treated group. (Auth.)

  14. Kettlebell lifting as a means of physical training of cadets at the higher military educational institution

    OpenAIRE

    Prontenko, K.; Griban, G.; Prontenko, V.; Andreychuk, V.; Tkachenko, P.; Kostyuk, Y.; Zhukovskyi, Y.; Пронтенко, К. В.; Грибан, Г. П.; Пронтенко, В. В.; Андрейчук, В. Я.; Ткаченко, П. П.; Костюк, Ю. С.; Жуковский, Е. И.; Жуковський, Є. І.

    2017-01-01

    The influence of the kettlebell lifting activities on the level of physical fitness level of cadets in higher military educational institution (HMEI) during the learning process was examined. Cadets in the 1st–5th year of study (n=474) who were studying according to the current system of physical training at a HMEI (group А, n=416) and cadets who were attending a kettlebell lifting class while the studying (group B, n=58) took part in the investigation. The level of physical fitness was exami...

  15. Transvaginal prolapse repair with or without the addition of a midurethral sling in women with genital prolapse and stress urinary incontinence: a randomised trial

    NARCIS (Netherlands)

    van der Ploeg, J. M.; Oude Rengerink, K.; van der Steen, A.; van Leeuwen, J. H. S.; Stekelenburg, J.; Bongers, M. Y.; Weemhoff, M.; Mol, B. W.; van der Vaart, C. H.; Roovers, J.-P. W. R.; Bergmans, Martin G.; Bongers, Marlies Y.; Dekker, Karin S.; van Gestel, Iris; Kluivers, Kirsten B.; Milani, A. L. Fred; van der Ploeg, J. Marinus; Oude Rengerink, Katrien; Schagen van Leeuwen, Jules H.; Schram, Aaltje J.; van der Steen, Annemarie; Stekelenburg, Jelle; van der Vaart, C. Huub; Weemhoff, Mirjam; Weis-Potters, Annemarie E.; Wijma, Jac

    2015-01-01

    To compare transvaginal prolapse repair combined with midurethral sling (MUS) versus prolapse repair only. Multi-centre randomised trial. Fourteen teaching hospitals in the Netherlands. Women with symptomatic stage two or greater pelvic organ prolapse (POP), and subjective or objective stress

  16. Transvaginal prolapse repair with or without the addition of a midurethral sling in women with genital prolapse and stress urinary incontinence : a randomised trial

    NARCIS (Netherlands)

    van der Ploeg, J. M.; Rengerink, K. Oude; van der Steen, A.; van Leeuwen, J. H. S.; Stekelenburg, J.; Bongers, M. Y.; Weemhoff, M.; Mol, B. W.; van der Vaart, C. H.; Roovers, J-P W. R.

    ObjectiveTo compare transvaginal prolapse repair combined with midurethral sling (MUS) versus prolapse repair only. DesignMulti-centre randomised trial. SettingFourteen teaching hospitals in the Netherlands. PopulationWomen with symptomatic stage two or greater pelvic organ prolapse (POP), and

  17. A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent:the SPIRIT II trial

    NARCIS (Netherlands)

    Serruys, Patrick W.; Ruygrok, Peter; Neuzner, Jörg; Piek, Jan J.; Seth, Ashok; Schofer, Joachim J.; Richardt, Gert; Wiemer, Marcus; Carrié, Didier; Thuesen, Leif; Boone, Els; Miquel-Herbert, Karine; Daemen, Joost

    2006-01-01

    Background: Everolimus has been successfully tested in humans using both an erodable and a durable polymer in small previous studies.Methods: This single blind multi-centre non-inferiority randomised (3:1) controlled trial evaluated the safety and performance of the XIENCE V Everolimus Eluting

  18. 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.

  19. [A pharmacist, creator of the first French daily paper: Cadet de Vaux].

    Science.gov (United States)

    Cailhol, C; Flahaut, J

    1998-01-01

    Cadet de Vaux, in partnership with Louis Dussieux and Olivier de Carancez, was the creator of the first French daily news paper, on the 1st of January 1877. Cadet had the responsibility of the scientific section. Several lampoons were written against the three directors of the paper. The paper was momentarily suppressed two times, because of non convenient contributions, and it was stopped his activities in the paper.

  20. 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

  1. APPENDIX TO THE MEASURING OF ENDURANCE OF CADETS IN HANDBALL

    Directory of Open Access Journals (Sweden)

    Dr Dragan Martinović

    2009-11-01

    Full Text Available At the sample of 80 handball cadet contestants aged between 16-17, there has been done an endurance testing in the discipline of running on a track of total of 12 and 6 minutes. The endurance was estimated in meters of the distance run. The aim of this task was to determine coorelation of the results in running on 12 and 6 minutes. The outcome is a total coorelation between the two. Running of the du- ration of 6 minutes is recommended for the trainer`s practice. Testing is more rational. With the application of the regressive analyses it has been determined that there is depenndance between running time and variables: weight, height and BMI

  2. ZOOM or Non-ZOOM? Assessing Spinal Cord Diffusion Tensor Imaging Protocols for Multi-Centre Studies.

    Directory of Open Access Journals (Sweden)

    Rebecca S Samson

    Full Text Available The purpose of this study was to develop and evaluate two spinal cord (SC diffusion tensor imaging (DTI protocols, implemented at multiple sites (using scanners from two different manufacturers, one available on any clinical scanner, and one using more advanced options currently available in the research setting, and to use an automated processing method for unbiased quantification. DTI parameters are sensitive to changes in the diseased SC. However, imaging the cord can be technically challenging due to various factors including its small size, patient-related and physiological motion, and field inhomogeneities. Rapid acquisition sequences such as Echo Planar Imaging (EPI are desirable but may suffer from image distortions. We present a multi-centre comparison of two acquisition protocols implemented on scanners from two different vendors (Siemens and Philips, one using a reduced field-of-view (rFOV EPI sequence, and one only using options available on standard clinical scanners such as outer volume suppression (OVS. Automatic analysis was performed with the Spinal Cord Toolbox for unbiased and reproducible quantification of DTI metrics in the white matter. Images acquired using the rFOV sequence appear less distorted than those acquired using OVS alone. SC DTI parameter values obtained using both sequences at all sites were consistent with previous measurements made at 3T. For the same scanner manufacturer, DTI parameter inter-site SDs were smaller for the rFOV sequence compared to the OVS sequence. The higher inter-site reproducibility (for the same manufacturer and acquisition details, i.e. ZOOM data acquired at the two Philips sites of rFOV compared to the OVS sequence supports the idea that making research options such as rFOV more widely available would improve accuracy of measurements obtained in multi-centre clinical trials. Future multi-centre studies should also aim to match the rFOV technique and signal-to-noise ratios in all

  3. Group treatments for sensitive health care problems : a randomised controlled trial of group versus individual physiotherapy sessions for female urinary incontinence

    OpenAIRE

    Lamb, S. E. (Sallie E.); Pepper, Jo; Lall, Ranjit; Jørstad-Stein , Ellen C.; Clark, M. D. (Michael D.); Hill, Lesley; Fereday Smith, Jan

    2009-01-01

    Abstract Background The aim was to compare effectiveness of group versus individual sessions of physiotherapy in terms of symptoms, quality of life, and costs, and to investigate the effect of patient preference on uptake and outcome of treatment. Methods A pragmatic, multi-centre randomised controlled trial in five British National Health Service physiotherapy departments. 174 women with stress and/or urge incontinence were randomised to receive treatment from a physiotherapist delivered in ...

  4. Doxycycline in the treatment of respiratory tract infections. Results of a pan-European multi-centre trial.

    Science.gov (United States)

    Pestel, M

    1975-01-01

    In the winter of 1973-4, general practitioners from seven European countries took part in a multi-centre trial of doxycycline in the treatment of infections of the respiratory tract. The carefully designed protocol was observed by all participants. A total of 1,747 patients were admitted to the trial; their ages ranged from 6 years to over 80. The commonest diagnoses (50%) were acute bronchitis and acute exacerbations of chronic bronchitis. On the recommended dosage of 200 mg doxycycline on the first day, followed by 100 mg daily thereafter (though 200 mg could be continued daily in severe cases), 87% of patients achieved good or very good results. Both subjective (pain) and objective (sputum volume and viscosity, temperature, cough) measures showed rapid improvement, usually by the third to fifth days. Side-effects were minimal and mainly gastrointestinal and caused only 4 patients to discontinue treatment. Overall, doxycycline proved its effectiveness and rapidity of action.

  5. Longitudinal Study of the Social Network Influences on the Leadership and Professional Military Development of Cadets at the U.S. Air Force Academy

    National Research Council Canada - National Science Library

    Packard, Gary

    1999-01-01

    .... Using a longitudinal design over an academic year (August 1997 to May 1998), the study examined the differences in the composition of cadet social groups and their influence on leadership development in two cadet squadrons...

  6. 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.

  7. 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

    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

  8. Does it matter if clinicians recruiting for a trial don't understand what the trial is really about? Qualitative study of surgeons' experiences of participation in a pragmatic multi-centre RCT

    Directory of Open Access Journals (Sweden)

    Snowdon Claire

    2007-01-01

    Full Text Available Abstract Background Qualitative methods are increasingly used to study the process of clinical trials and patients understanding of the rationale for trials, randomisation and reasons for taking part or refusing. Patients' understandings are inevitably influenced by the recruiting clinician's understanding of the trial, yet relatively little qualitative work has explored clinicians' perceptions and understandings of trials. This study interviewed surgeons shortly after the multi-centre, pragmatic RCT in which they had participated had been completed. Methods We used in-depth interviews with surgeons who participated in the Spine Stabilisation Trial (a pragmatic RCT to explore their understanding of the trial purpose and how this understanding had influenced their recruitment procedures and interpretation of the results. A purposive sample of eleven participating surgeons was chosen from 8 of the 15 UK trial centres. Results Although the surgeons thought that the trial was addressing an important question there was little agreement about what this question was: although it was a trial of 'equivalent' treatments, some thought that it was a trial of surgery, others a trial of rehabilitation and others that it was exploring what to do with patients in whom all other treatment options had been unsuccessful. The surgeons we interviewed were not aware of the rationale for the pragmatic inclusion criteria and nearly all were completely baffled about the meaning of 'equipoise'. Misunderstandings about the entry criteria were an important source of confusion about the results and led to reluctance to apply the results to their own practice. Conclusion The study suggests several lessons for the conduct of future multi-centre trials. Recruiting surgeons (and other clinicians may not be familiar with the rationale for pragmatic designs and may need to be regularly reminded about the purpose during the study. Reassurance may be necessary that a pragmatic

  9. 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.

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

    International Nuclear Information System (INIS)

    Tahmasebi, Amir M.; Mareckova, Klara; Artiges, Eric; Martinot, Jean-Luc; Banaschewski, Tobias; Barker, Gareth J.; Loth, Eva; Schumann, Gunter; Bruehl, Ruediger; Ittermann, Bernd; Buchel, Christian; Conrod, Patricia J.; Flor, Herta; Strohle, Andreas; Garavan, Hugh; Gallinat, Jurgen; Heinz, Andreas; Poline, Jean-Baptiste; Rietschel, Marcella; Smolka, Michael N.; Paus, Tomas

    2012-01-01

    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)

  11. 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.

  12. Creation and Support of the State of Psychological Safety of Pupils of Cadet Classes

    Directory of Open Access Journals (Sweden)

    Baeva I.A.,

    2017-01-01

    Full Text Available The author's approach to the support of psychological safety in the educational process. As cadet classes make high demands to the capabilities and resources of the child, the task of tracking these educational programs in terms of psychological safety of children is particularly relevant. The study tested the assumption that the program support the state of psychological safety, implementing a risk-resource approach and aimed at updating / generation components of psychological safety (satisfaction, protection, reference, subjective well-being of the child in the Cadet educational environment, activity, will be effective when accompanied by cadet training programs. Testing of the developed program was carried out with students of third cadet classes (53 people in the experimental group and 26 in the control group. components and criteria of psychological safety of the younger schoolboy were determined on the basis of theoretical analysis. The methods of interrogation (questioning, testing, projective method examined the children, parents and teachers in the cadet classes to identify the initial and final levels of psychological safety of younger students. Statistical analysis were used cluster and discriminant analysis, chi-square test for contingency tables, sign test G. The article describes the features of the program, aimed at the formation and maintenance of psychological safety of younger pupils, pupils of cadet classes. The efficiency of it on all the selected criteria with a level of significance of not more than p <0,005. Ideas forming program can be used in the practice of psychological work in schools, as well as for further research of psychological safety of children in the educational environment of schools of different types and species.

  13. STRUCTURAL AND METHODICAL MODEL OF INCREASING THE LEVEL OF THEORETICAL TRAINING OF CADETS USING INFORMATION AND COMMUNICATION TECHNOLOGIES

    Directory of Open Access Journals (Sweden)

    Vladislav V. Bulgakov

    2018-03-01

    Full Text Available Features of training in higher educational institutions of system of EMERCOM of Russia demand introduction of the new educational techniques and the technical means directed on intensification of educational process, providing an opportunity of preparation of cadets at any time in the independent mode and improving quality of their theoretical knowledge. The authors have developed a structural and methodological model of increasing the level of theoretical training of cadets using information and communication technologies. The proposed structural and methodological model that includes elements to stimulate and enhance cognitive activity, allows you to generate the trajectory of theoretical training of cadets for the entire period of study at the University, to organize a systematic independent work, objective, current and final control of theoretical knowledge. The structural and methodological model for improving the level of theoretical training consists of three main elements: the base of theoretical questions, functional modules "teacher" and "cadet". The basis of the structural and methodological model of increasing the level of theoretical training of cadets is the base of theoretical issues, developed in all disciplines specialty 20.05.01 – fire safety. The functional module "teacher" allows you to create theoretical questions of various kinds, edit questions and delete them from the database if necessary, as well as create tests and monitor their implementation. The functional module "cadet" provides ample opportunities for theoretical training through independent work, testing for current and final control, the implementation of the game form of training in the form of a duel, as well as for the formation of the results of the cadets in the form of statistics and rankings. Structural and methodical model of increasing the level of theoretical training of cadets is implemented in practice in the form of a multi-level automated system

  14. Reproducibility of a semi-automatic method for 6-point vertebral morphometry in a multi-centre trial

    International Nuclear Information System (INIS)

    Guglielmi, Giuseppe; Stoppino, Luca Pio; Placentino, Maria Grazia; D'Errico, Francesco; Palmieri, Francesco

    2009-01-01

    Purpose: To evaluate the reproducibility of a semi-automated system for vertebral morphometry (MorphoXpress) in a large multi-centre trial. Materials and methods: The study involved 132 clinicians (no radiologist) with different levels of experience across 20 osteo-centres in Italy. All have received training in using MorphoXpress. An expert radiologist was also involved providing data used as standard of reference. The test image originate from normal clinical activity and represent a variety of normal, under and over exposed films, indicating both normal anatomy and vertebral deformities. The image was represented twice to the clinicians in a random order. Using the software, the clinicians initially marked the midpoints of the upper and lower vertebrae to include as many of the vertebrae (T5-L4) as practical within each given image. MorphoXpress performs the localisation of all morphometric points based on statistical model-based vision system. Intra-operator as well inter-operator measurement of agreement was calculated using the coefficient of variation and the mean and standard deviation of the difference of two measurements to check their agreement. Results: The overall intra-operator mean differences in vertebral heights is 1.61 ± 4.27% (1 S.D.). The overall intra-operator coefficient of variation is 3.95%. The overall inter-operator mean differences in vertebral heights is 2.93 ± 5.38% (1 S.D.). The overall inter-operator coefficient of variation is 6.89%. Conclusions: The technology tested here can facilitate reproducible quantitative morphometry suitable for large studies of vertebral deformities

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

    Directory of Open Access Journals (Sweden)

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

    Science.gov (United States)

    Finnbogadóttir, Hafrún; Dejin-Karlsson, Elisabeth; Dykes, Anna-Karin

    2011-02-21

    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. 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. 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). 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.

  17. 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

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

    Science.gov (United States)

    2011-01-01

    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. PMID:21338523

  19. Luteinizing hormone-releasing hormone analogue (Buserelin) treatment for central precocious puberty: a multi-centre trial.

    Science.gov (United States)

    Werther, G A; Warne, G L; Ennis, G; Gold, H; Silink, M; Cowell, C T; Quigley, C; Howard, N; Antony, G; Byrne, G C

    1990-02-01

    A multi-centre open trial of Buserelin, a luteinizing hormone-releasing hormone (LHRH) analogue, was conducted in 13 children with central precocious puberty. Eleven children (eight girls and three boys), aged 3.4-10.2 years at commencement, completed the required 12 month period of treatment. Initially all patients received the drug by intranasal spray in a dose of 1200 micrograms/day, but by the end of the 12 month period two were having daily subcutaneous injections and three were receiving an increased dose intranasally. The first month of treatment was associated in one boy with increased aggression and masturbation, and in the girls with an increase in the prevalence of vaginal bleeding. Thereafter, however, both behavioural abnormalities and menstruation were suppressed. Median bone age increased significantly during the study, but without any significant change in the ratio of height age to bone age. The median predicted adult height for the group therefore did not alter significantly over the twelve months of the study. Buserelin treatment caused a reduction in the peak luteinizing hormone and follicle-stimulating hormone (FSH) responses to LHRH, mostly to prepubertal levels, and also suppressed basal FSH. In the first weeks of treatment, the girls' serum oestradiol levels rose significantly and then fell to prepubertal or early pubertal levels. A similar pattern was seen for serum testosterone levels. Serum somatomedin-C levels, however, showed little fluctuation over the course of the study. Buserelin treatment was safe and well accepted, and offers the promise of improved linear growth potential in precocious puberty.

  20. Burnout, psychological morbidity and use of coping mechanisms among palliative care practitioners: A multi-centre cross-sectional study.

    Science.gov (United States)

    Koh, Mervyn Yong Hwang; Chong, Poh Heng; Neo, Patricia Soek Hui; Ong, Yew Jin; Yong, Woon Chai; Ong, Wah Ying; Shen, Mira Li Juan; Hum, Allyn Yin Mei

    2015-07-01

    The prevalence of burnout, psychological morbidity and the use of coping mechanisms among palliative care practitioners in Singapore have not been studied. We aimed to study the prevalence of burnout and psychological morbidity among palliative care practitioners in Singapore and its associations with demographic and workplace factors as well as the use of coping mechanisms. This was a multi-centre, cross-sectional study of all the palliative care providers within the public healthcare sector in Singapore. The study was conducted in hospital palliative care services, home hospice and inpatient hospices in Singapore. The participants were doctors, nurses and social workers. The prevalence of burnout among respondents in our study was 91 of 273 (33.3%) and psychological morbidity was 77 (28.2%). Working >60 h per week was significantly associated with burnout (odds ratio: 9.02, 95% confidence interval: 2.3-35.8, p = 0.002) and psychological morbidity (odds ratio: 7.21, 95% confidence interval: 1.8-28.8, p = 0.005). Home hospice care practitioners (41.5%) were more at risk of developing psychological morbidity compared to hospital-based palliative care (17.5%) or hospice inpatient care (26.0%) (p = 0.007). Coping mechanisms like physical well-being, clinical variety, setting boundaries, transcendental (meditation and quiet reflection), passion for one's work, realistic expectations, remembering patients and organisational activities were associated with less burnout. Our results reveal that burnout and psychological morbidity are significant in the palliative care community and demonstrate a need to look at managing long working hours and promoting the use of coping mechanisms to reduce burnout and psychological morbidity. © The Author(s) 2015.

  1. Perceived Stress, Wellness, and Mattering: A Profile of First-Year Citadel Cadets

    Science.gov (United States)

    Gibson, Donna M.; Myers, Jane E.

    2006-01-01

    Cadets (N = 234) at The Citadel (a military college for males and females in the Southeast United States) completed measures of wellness, perceived stress, and mattering during their first semester of training. Overall, wellness scores were negatively skewed. Although there were no differences in perceived stress or mattering between The Citadel…

  2. 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 is...

  3. Tertiary Journalism Education: Its Value in Cadet Selection at Metropolitan Media.

    Science.gov (United States)

    Alysen, Barbara

    2001-01-01

    Notes tertiary study in journalism has been a feature of the education of Australian journalists for decades, yet many industry representatives remain skeptical of its value. Finds applicants for entry-level jobs with a tertiary journalism qualification can expect to secure, on average, at least half the available positions in any cadet or trainee…

  4. Risk factors for musculoskeletal injuries among Greek Army officer cadets undergoing Basic Combat Training.

    Science.gov (United States)

    Havenetidis, Konstantinos; Paxinos, Thrasivoulos

    2011-10-01

    Predictors of work-related injuries were assessed using data from a group of Greek Army officer cadets. Cadets (n = 253) were monitored by physicians for musculoskeletal injuries resulting through a 7-week Basic Combat Training (BCT) period. Potential predictors of musculoskeletal injuries (Cadets' entry number, body mass index [BMI], body fat percentage [BFP], gender, age, sport experience, and nationality) were modeled via univariate and multivariate logistic regressions. Using odds ratio (OR) and confidence interval (CI), it was shown that older age (OR = 0.73; 95% CI = 0.56-0.96), female gender (OR = 0.13; 95% CI = 0.02-0.81), high BFP (OR = 1.21; 95% CI = 1.07-1.37), and Greek nationality (OR = 0.22; 95% CI = 0.07-0.69) were all associated with musculoskeletal injuries. These factors, except for gender, were also related to overuse injuries. During BCT, adiposity expressed as BFP and not as BMI can predict the magnitude and type (acute-overuse) of musculoskeletal injuries in Greek cadets.

  5. Suitable Penalty for Breach of Contract: AFROTC Cadets. A Research Report Submitted to the Faculty.

    Science.gov (United States)

    Reese, Robert D.

    A legislative history of financial incentives in the Reserve Officer Training Corps gives perspective to an analysis of present law and policy concerning breach of contract for Air Force ROTC cadets. The changed environment, criticisms of the present law and policy, and the example of three other Western nations with all volunteer militaries are…

  6. The Effect of Higher Education Variables on Cadet Performance during 1987 Light Aircraft Training

    Science.gov (United States)

    1989-05-01

    next year’s selection pool. Cadets removed from the LATR program due to airsickness, MOA, SIE, illness, or injury were not included in the quantitative...of varsity athletics does not screen specifically for physiological traits. A varsity college marksman is included, as is a weightlifter . The actual

  7. Methodical basis of training of cadets for the military applied heptathlon competitions

    Directory of Open Access Journals (Sweden)

    R.V. Anatskyi

    2017-12-01

    Full Text Available The purpose of the research is to develop methodical bases of training of cadets for the military applied heptathlon competitions. Material and methods: Cadets of 2-3 courses at the age of 19-20 years (n=20 participated in researches. Cadets were selected by the best results of exercises performing included into the program of military applied heptathlon competitions (100 m run, 50 m freestyle swimming, Kalashnikov rifle shooting, pull-up, obstacle course, grenade throwing, 3000 m run. Preparation took place on the basis of training center. All trainings were organized and carried out according to the methodical basics: in a week preparation microcycle five days cadets had two trainings a day (on Saturday was one training, on Sunday they had rest. The selected exercises with individual loads were performed, Results : Sport scores demonstrated top results in the performance of 100 m run, 3000 m run and pull-up. The indices of performing exercise "obstacle course" were much lower than expected. Rather low results were demonstrated in swimming and shooting. Conclusions . Results of researches indicate the necessity of quality improvement: cadets’ weapons proficiency; physical readiness to perform the exercises requiring complex demonstration of all physical qualities.

  8. Leadership Skills of Faculty Members at Al-Istiqlal University: Cadets' Point of Views

    Science.gov (United States)

    Samra, Mahmoud A. Abu

    2014-01-01

    The aim of this study is to determine the availability of leadership skills of faculty members (civilian and military personnel) at Al- Istiqlal university (AIU). The population of the study was composed of AIU students, including juniors and sophomores. A random sample, consisting of 137 cadets, was chosen. The researcher developed a…

  9. 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

  10. Effect of centrifuge test on blood serum lipids index of cadet pilots.

    Science.gov (United States)

    Wochyński, Zbigniew; Kowalczuk, Krzysztof; Kłossowski, Marek; Sobiech, Krzysztof A

    2016-01-01

    This study aimed at investigating the relationship between the lipid index (WS) in the examined cadets and duration of exposure to +Gz in the human centrifuge. The study involved 19 first-year cadets of the Polish Air Force Academy in Dęblin. Tests in the human centrifuge were repeated twice, i.e. prior to (test I) and 45 days after (test II). After exposure to +Gz, the examined cadets were divided into 2 groups. Group I (N=11) included cadets subjected to a shorter total duration of exposure to +Gz, while group II (N=8) included cadets with a longer total duration of exposure to +Gz. Total cholesterol (TC), high density lipoprotein (HDL), triglycerides (TG), and apolipoproteins A1 and B were assayed in blood serum prior to (assay A) and after (assay B) both exposures to +Gz. Low density lipoprotein (LDL) level was estimated from the Friedewald formula. WS is an own mathematical algorithm. WS was higher in group II, assay A - 10.0 and B - 10.08 of test I in the human centrifuge than in group I where the WS values were 6.91 and 6.96, respectively. WS was also higher in group II in assay A - 10.0 and B -10.1 of test II in the human centrifuge than in group I - 6.96 and 6.80, respectively. The higher value of WS in group II, both after the first and second exposure to +Gz in human centrifuge, in comparison with group I, indicated its usefulness for determination of the maximum capability of applying acceleration of the interval type during training in the human centrifuge.

  11. A Longitudinal and Qualitative Descriptive Study of Cadet Moral Judgment Development at the United States Air Force Academy

    National Research Council Canada - National Science Library

    Luedtke, Christopher

    1999-01-01

    ...) and Moral Experience Questionnaire (MEQ). The objective was to observe whether changes occurred in the moral judgment scores of cadets between entry into the Academy and the spring semester of their senior year...

  12. A multi-centre study of interactional style in nurse specialist- and physician-led Rheumatology clinics in the UK.

    Science.gov (United States)

    Vinall-Collier, Karen; Madill, Anna; Firth, Jill

    2016-07-01

    Nurse-led care is well established in Rheumatology in the UK and provides follow-up care to people with inflammatory arthritis including treatment, monitoring, patient education and psychosocial support. The aim of this study is to compare and contrast interactional style with patients in physician-led and nurse-led Rheumatology clinics. A multi-centre mixed methods approach was adopted. Nine UK Rheumatology out-patient clinics were observed and audio-recorded May 2009-April 2010. Eighteen practitioners agreed to participate in clinic audio-recordings, researcher observations, and note-taking. Of 9 nurse specialists, 8 were female and 5 of 9 physicians were female. Eight practitioners in each group took part in audio-recorded post-clinic interviews. All patients on the clinic list for those practitioners were invited to participate and 107 were consented and observed. In the nurse specialist cohort 46% were female; 71% had a diagnosis of Rheumatoid Arthritis (RA). The physician cohort comprised 31% female; 40% with RA and 16% unconfirmed diagnosis. Nineteen (18%) of the patients observed were approached for an audio-recorded telephone interview and 15 participated (4 male, 11 female). Forty-four nurse specialist and 63 physician consultations with patients were recorded. Roter's Interactional Analysis System (RIAS) was used to code this data. Thirty-one semi-structured interviews were conducted (16 practitioner, 15 patients) within 24h of observed consultations and were analyzed using thematic analysis. RIAS results illuminated differences between practitioners that can be classified as 'socio-emotional' versus 'task-focussed'. Specifically, nurse specialists and their patients engaged significantly more in the socio-emotional activity of 'building a relationship'. Across practitioners, the greatest proportion of 'patient initiations' were in 'giving medical information' and reflected what patients wanted the practitioner to know rather than giving insight into

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

    International Nuclear Information System (INIS)

    McNiven, A; Jaffray, D; Letourneau, D

    2015-01-01

    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

  14. 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

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

    NARCIS (Netherlands)

    Raes, V.; Jong, C.A.J. de; Bacquer, D. De; Broekaert, E.; Maeseneer, J. De

    2011-01-01

    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.

  16. The effect of using assessment instruments on substance-abuse outpatients' adherence to treatment: a multi-centre randomised controlled trial.

    NARCIS (Netherlands)

    Raes, V.; Jong, C.A.J. de; Bacquer, D. De; Broekaert, E.; Maeseneer, J. De

    2011-01-01

    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.

  17. 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.

  18. 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

    injection (n = 372) showed Bemfola yielding similar efficacy and safety profiles to Gonal-f. Women aged 20-38 years of age were randomized 2:1 to receive a single, daily, subcutaneous 150 IU dose of either Bemfola or Gonal-f. This study tested equivalence in the number of retrieved oocytes using a pre......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...

  19. Program-Level Variation in Cadet Outcomes at the National Guard Youth ChalleNGe Program

    Science.gov (United States)

    2016-12-01

    ChalleNGe is to help “young people improve their self - esteem , self -confidence, life skills , education levels, and employment potential” [2...discipline), whether he thinks the development of cognitive or noncognitive skills is more important, and how often the cadets communicate with...components: 1. Leadership/followership 2. Responsible citizenship 3. Service to community 4. Life-coping skills 5. Physical fitness 6. Health and

  20. A Proposal for the Merger of the U.S. Army Recruiting Command (USAREC) and the U.S. Army Cadet Command: One Recruiting Organization - "More Than a Partnership"

    National Research Council Canada - National Science Library

    Kleppinger, Tim

    2001-01-01

    ...) and the United States Army Cadet Command into one accessions organization. For the past five years both USAREC and Cadet Command have found greater difficulty in achieving their annual missions...

  1. Photogrammetry on the identification of postural asymmetries in cadets and pilots of the Brazilian air force academy.

    Science.gov (United States)

    Figueiredo, Rodrigo V; Amaral, Artur C; Shimano, Antônio C

    2012-01-01

    To identify whether flight training activities cause postural changes in cadets and pilots of the Brazilian Air Force Academy (AFA). 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 Analysis Program (SAPO) and angles related to head vertical alignment (HVA), head horizontal alignment (HHA), acromion horizontal alignment (AHA) and anterior-superior iliac spine horizontal alignment (HAS) were plotted. We did not find statistical significant differences in the angles: HVA, HHA and AHA. However, a significant difference was found for the HAS angle with pilots having lower values than cadets, suggesting greater postural stability for this variable in pilots. The horizontal alignment of the anterior-superior iliac spine was the only measure that showed significant difference in the comparison between pilots and cadets. The remaining alignments were not different, possibility because of the strict criteria used for admission of cadets at the AFA and the efficiency of the physical training that is performed periodically.

  2. Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate

    DEFF Research Database (Denmark)

    Heliövaara, Arja; Küseler, Annelise; Skaare, Pål

    2017-01-01

    BACKGROUND AND AIM: Good dentofacial growth is a major goal in the treatment of unilateral cleft lip and palate (UCLP). The aim was to evaluate dental arch relationships at age 5 years after four different protocols of primary surgery for UCLP. DESIGN: Three parallel randomised clinical trials were...... undertaken as an international multi-centre study by 10 cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK. METHODS: Three different surgical procedures for primary palatal repair (Arms B, C, D) were tested against a common procedure (Arm A) in the total cohort of 448 children born...

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

    Directory of Open Access Journals (Sweden)

    Roeyers Herbert

    2011-04-01

    Full Text Available 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

  4. 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

  5. Cancer Trials Ireland (ICORG) 06-34: A multi-centre clinical trial using three-dimensional conformal radiation therapy to reduce the toxicity of palliative radiation for lung cancer.

    Science.gov (United States)

    McDermott, Ronan L; Armstrong, John G; Thirion, Pierre; Dunne, Mary; Finn, Marie; Small, Cormac; Byrne, Mary; O'Shea, Carmel; O'Sullivan, Lydia; Shannon, Aoife; Kelly, Emma; Hacking, Dayle J

    2018-05-01

    Cancer Trials Ireland (ICORG) 06-34: A multi-centre clinical trial using three-dimensional conformal radiation therapy to reduce the toxicity of palliative radiation for lung cancer. NCT01176487. Trials of radiation therapy for the palliation of intra-thoracic symptoms from locally advanced non-small cell lung cancer (NSCLC) have concentrated on optimising fractionation and dose schedules. In these trials, the rates of oesophagitis induced by this "palliative" therapy have been unacceptably high. In contrast, this non-randomised, single-arm trial was designed to assess if more technically advanced treatment techniques would result in equivalent symptom relief and reduce the side-effect of symptomatic oesophagitis. Thirty-five evaluable patients with symptomatic locally advanced or metastatic NSCLC were treated using a three-dimensional conformal technique (3-DCRT) and standardised dose regimens of 39 Gy in 13 fractions, 20 Gy in 5 fractions or 17 Gy in 2 fractions. Treatment plans sought to minimise oesophageal dose. Oesophagitis was recorded during treatment, at two weeks, one month and three months following radiation therapy and 3-6 monthly thereafter. Mean dose to the irradiated oesophagus was calculated for all treatment plans. Five patients (14%) had experienced grade 2 oesophagitis or dysphagia or both during treatment and 2 other patients had these side effects at the 2-week follow-up. At follow-up of one month after therapy, there was no grade two or higher oesophagitis or dysphagia reported. 22 patients were eligible for assessment of late toxicity. Five of these patients reported oesophagitis or dysphagia (one had grade 3 dysphagia, two had grade 2 oesophagitis, one of whom also had grade 2 dysphagia). Quality of Life (QoL) data at baseline and at 1-month follow up were available for 20 patients. At 1-month post radiation therapy, these patients had slightly less trouble taking a short walk, less shortness of breath, did not feel as weak, had

  6. Heterogeneous FDG-guided dose-escalation for locally advanced NSCLC (the NARLAL2 trial): Design and early dosimetric results of a randomized, multi-centre phase-III study

    DEFF Research Database (Denmark)

    Møller, Ditte Sloth; Nielsen, Tine Bjørn; Brink, Carsten

    2017-01-01

    Background and purpose: Local recurrence is frequent in locally advanced NSCLC and is primarily located in FDG-avid parts of tumour and lymph nodes. Aiming at improving local control without increasing toxicity, we designed a multi-centre phase-III trial delivering inhomogeneous dose-escalation d......Background and purpose: Local recurrence is frequent in locally advanced NSCLC and is primarily located in FDG-avid parts of tumour and lymph nodes. Aiming at improving local control without increasing toxicity, we designed a multi-centre phase-III trial delivering inhomogeneous dose...

  7. Frequency of participation of 8-12-year-old children with cerebral palsy: a multi-centre cross-sectional European study

    DEFF Research Database (Denmark)

    Michelsen, Susan I; Flachs, Esben M; Uldall, Peter

    2008-01-01

    might influence participation. We undertook a multi-centre, population-based study in children with and without cerebral palsy. Working from the Life-H instrument, we developed a questionnaire to capture frequency of participation in 8-12-year-old children. In nine regions of seven European countries......, parents of 813 children with cerebral palsy and 2939 children from the general populations completed the questionnaire. Frequency of participation for each question was dichotomised about the median; multivariable logistic regressions were carried out. In the general population, frequency of participation...... varied between countries. Children with cerebral palsy participated less frequently in many but not all areas of everyday life, compared with children from the general population. There was regional variation in the domains with reduced participation and in the magnitude of the differences. We discuss...

  8. Computerized detection of breast lesions in multi-centre and multi-instrument DCE-MR data using 3D principal component maps and template matching

    Science.gov (United States)

    Ertas, Gokhan; Doran, Simon; Leach, Martin O.

    2011-12-01

    In this study, we introduce a novel, robust and accurate computerized algorithm based on volumetric principal component maps and template matching that facilitates lesion detection on dynamic contrast-enhanced MR. The study dataset comprises 24 204 contrast-enhanced breast MR images corresponding to 4034 axial slices from 47 women in the UK multi-centre study of MRI screening for breast cancer and categorized as high risk. The scans analysed here were performed on six different models of scanner from three commercial vendors, sited in 13 clinics around the UK. 1952 slices from this dataset, containing 15 benign and 13 malignant lesions, were used for training. The remaining 2082 slices, with 14 benign and 12 malignant lesions, were used for test purposes. To prevent false positives being detected from other tissues and regions of the body, breast volumes are segmented from pre-contrast images using a fast semi-automated algorithm. Principal component analysis is applied to the centred intensity vectors formed from the dynamic contrast-enhanced T1-weighted images of the segmented breasts, followed by automatic thresholding to eliminate fatty tissues and slowly enhancing normal parenchyma and a convolution and filtering process to minimize artefacts from moderately enhanced normal parenchyma and blood vessels. Finally, suspicious lesions are identified through a volumetric sixfold neighbourhood connectivity search and calculation of two morphological features: volume and volumetric eccentricity, to exclude highly enhanced blood vessels, nipples and normal parenchyma and to localize lesions. This provides satisfactory lesion localization. For a detection sensitivity of 100%, the overall false-positive detection rate of the system is 1.02/lesion, 1.17/case and 0.08/slice, comparing favourably with previous studies. This approach may facilitate detection of lesions in multi-centre and multi-instrument dynamic contrast-enhanced breast MR data.

  9. 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)

    Foroudi, Farshad; Pham, Daniel; Rolfo, Aldo; Bressel, Mathias; Tang, Colin I.; Tan, Alex; Turner, Sandra; Hruby, George; Williams, Stephen; Hayne, Dickon; Lehman, Margot; Skala, Marketa; Jose, Chakiath C.; Gogna, Kumar; Kron, Tomas

    2014-01-01

    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

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

    Science.gov (United States)

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

    2016-03-11

    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. 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. Predictive BIA equations showed significant differences in FFM compared to DXA (p FFM variance. Specific BIA equations showed no significant differences in FFM, compared to DXA values. 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.

  11. Generación de superficies curvas utilizando el programa CADET

    Directory of Open Access Journals (Sweden)

    Recuero, Alfonso

    1987-02-01

    Full Text Available In this paper an extension to the CADET program, for the perspective drawing of 3— dimensional objects, is described. By means of this extension playing contours can be defined in their plane, which can subsequently be used in the generation of complex primitives. This contours may define the meridian curve of surfaces of revolution, the directive curve of conical or cilindrical surfaces, the borders of complicate plane elements, etc. The listings of the subroutines, written in HP-BASIC, are included together with a comprehensive explanation of how to use it in generating a complet object.

    En el presente trabajo se muestra una extensión del programa CADET, para el dibujo de perspectivas de objetos tridimensionales, mediante la cual es posible generar contornos planos descritos en su propio plano y que posteriormente sirven de base en la definición de primitivas complejas. Estos contornos pueden representar las meridianas de superficies de revolución, la directriz de superficies cilíndricas o cónicas, los bordes de elementos planos complicados, etc. Se incluyen los listados en HP-BASIC de las subrutinas de generación y dibujo de estos contornos, así como una descripción detallada de su utilización con un objeto completo.

  12. Physical activity levels as a quantifier in police officers and cadets

    Directory of Open Access Journals (Sweden)

    Andrzej Soroka

    2014-08-01

    Full Text Available Objectives: The aim of the present study was to determine the physical activity levels of active duty police officers and police academy cadets in different life domains and intensities. These parameters were treated as potential quantifiers that could be used when assessing individuals preparing for work as future police officers. Material and Methods: The study recruited 153 active police officers and 176 cadets attending a police academy and administered a diagnostic survey, the long-form version of the International Physical Activity Questionnaire, while in the statistical analysis the Student's t-test for independent groups was applied. Results: It was determined that police officers present high physical activity levels within the work domain, which are developed from initial training at a police academy and then throughout their police career. Conclusions: Such data are important in the light of the role police officers play in public safety as well as the prominence of physical activity within a particular profession and how it can be targeted and tailored to their needs.

  13. 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.

  14. Development of Android Application for Measuring Cardiovascular Endurance Fitness for Military Cadet Officers

    Science.gov (United States)

    Kassim, Mohar; Zaidi, Ahmad Mujahid Ahmad; Sholihin Mokhtar, Rahmat

    2018-05-01

    Mobile software application has become a part of today’s lifestyle. This mobile app is designed to help society to be physically active. The application is named UPNM Cardio Fitness, and is developed on the Android platform. The original purpose of the application is to measure and analyse the level of cardiovascular fitness of 18 years old male Military cadet Officers through a 2.4 km run test. The application is based on a data base using Google Fusion Table that stores and analyses the data received. The application consists of two parts: information of the individual and their respective fitness norms that can be accessed either automatically or manually. The classification of the norms is obtained from the fitness norms of 120 male cadets aged 18 years old. The norms are grouped into five categories which are: Excellent, Very Good, Good, Moderate and Poor. The software consists of 5 hyperlinks which are the main page, individual information, test result, file and record. The application is created using MIT App Inventor Software and Windows 7. The creation of the application has enabled researchers particularly in the Science Training programme in UPNM to carry out tests as well as to identify the level of fitness of their trainees immediately, accurately, and systematically.

  15. 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.

  16. Assessment of risk associated with exposure to tobacco and alcohol on health of the cadets of military institute and its prevention methodology

    Directory of Open Access Journals (Sweden)

    М.Sh. Belikova

    2015-06-01

    Full Text Available The work is devoted to the studies of the problem of smoking and alcohol use among cadets of military institute as well as to the risk of diseases’ developing when using nicotine and alcohol. We have proposed the methods for solving this problem in the educational institution. This article describes not only the problem among the cadets of military institute, but also the calculated risks. Particular attention is paid to the study of the methods of controlling the bad habits in the educational institution and reduction of the number of smokers and drinkers among the cadets.

  17. 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,…

  18. Evolution of the Schoolmarm Stereotype: The Impact of the Feminization of Education on Two Male Teacher Cadets

    Science.gov (United States)

    McClanahan, Constance Stolark

    2012-01-01

    The primary purpose of this study was to examine the perceptions of two male students and their teacher who participated in a Teacher Cadet Program over the 2010-2011 academic year. The qualitative case study took place at the Royal Fern High School (RFHS) (pseudonym) in Cypress Grove County (pseudonym), located outside of Charleston, SC. The…

  19. 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

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

    Directory of Open Access Journals (Sweden)

    Roeyers Herbert

    2011-04-01

    Full Text Available 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

  1. 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

  2. The importance of dietary change for men diagnosed with and at risk of prostate cancer: a multi-centre interview study with men, their partners and health professionals.

    Science.gov (United States)

    Avery, Kerry N L; Donovan, Jenny L; Horwood, Jeremy; Neal, David E; Hamdy, Freddie C; Parker, Chris; Wade, Julia; Lane, Athene

    2014-05-03

    The diagnosis of prostate cancer (PC) can provide a trigger for dietary change, and there is evidence that healthier diets may improve quality of life and clinical outcomes. However, men's views about dietary change in PC survivorship are largely unknown. This multi-centre qualitative interview study explored men's views about dietary change in PC survivorship, to better understand motivations for, and barriers to, achieving desired changes. The role of radical and active surveillance treatments on dietary change and the influence of men's partners were examined. Focus groups also evaluated stakeholder opinion, including healthcare professionals, about the provision of dietary advice to PC patients. A multi-centre interview study explored views about diet and motivations for, and barriers to, dietary change in men at elevated risk or diagnosed with PC following prostate specific antigen (PSA) testing. 58 men and 11 partners were interviewed. Interviews and focus groups were undertaken with 11 healthcare professionals, 5 patients and 4 partners to evaluate stakeholders' opinions about the feasibility and acceptability of providing dietary advice to PC patients. Data were analysed using methods of constant comparison and thematic analysis. Over half of diagnosed men reported making dietary changes, primarily to promote general or prostate health or facilitate coping, despite their uncertainty about diet-PC links. Interest in dietary advice was high. Information needs varied depending on treatment received, with men on active surveillance more frequently modifying their diet and regarding this as an adjunct therapy. Men considered their partners integral to implementing changes. Provision of dietary advice to men diagnosed with PC was considered by healthcare professionals and men to be feasible and appropriate in the context of a holistic 'care package'. Many men make positive dietary changes after PC diagnosis, which are perceived by men and their partners to bring

  3. Critical Care Health Informatics Collaborative (CCHIC): Data, tools and methods for reproducible research: A multi-centre UK intensive care database.

    Science.gov (United States)

    Harris, Steve; Shi, Sinan; Brealey, David; MacCallum, Niall S; Denaxas, Spiros; Perez-Suarez, David; Ercole, Ari; Watkinson, Peter; Jones, Andrew; Ashworth, Simon; Beale, Richard; Young, Duncan; Brett, Stephen; Singer, Mervyn

    2018-04-01

    To build and curate a linkable multi-centre database of high resolution longitudinal electronic health records (EHR) from adult Intensive Care Units (ICU). To develop a set of open-source tools to make these data 'research ready' while protecting patient's privacy with a particular focus on anonymisation. We developed a scalable EHR processing pipeline for extracting, linking, normalising and curating and anonymising EHR data. Patient and public involvement was sought from the outset, and approval to hold these data was granted by the NHS Health Research Authority's Confidentiality Advisory Group (CAG). The data are held in a certified Data Safe Haven. We followed sustainable software development principles throughout, and defined and populated a common data model that links to other clinical areas. Longitudinal EHR data were loaded into the CCHIC database from eleven adult ICUs at 5 UK teaching hospitals. From January 2014 to January 2017, this amounted to 21,930 and admissions (18,074 unique patients). Typical admissions have 70 data-items pertaining to admission and discharge, and a median of 1030 (IQR 481-2335) time-varying measures. Training datasets were made available through virtual machine images emulating the data processing environment. An open source R package, cleanEHR, was developed and released that transforms the data into a square table readily analysable by most statistical packages. A simple language agnostic configuration file will allow the user to select and clean variables, and impute missing data. An audit trail makes clear the provenance of the data at all times. Making health care data available for research is problematic. CCHIC is a unique multi-centre longitudinal and linkable resource that prioritises patient privacy through the highest standards of data security, but also provides tools to clean, organise, and anonymise the data. We believe the development of such tools are essential if we are to meet the twin requirements of

  4. Comparison of injury rates between cadets with limb length inequalities and matched control subjects over 1 year of military training and athletic participation.

    Science.gov (United States)

    Goss, Donald Lee; Moore, Josef H; Slivka, Erin M; Hatler, Brian S

    2006-06-01

    To compare lower-limb overuse injury and low back pain incidence among cadets with and without limb length inequality (LLI) over 1 year of military training and athletic participation. A total of 1,100 cadets were screened for LLIs; 126 of 1,100 were identified to have a LLI of > 0.5 cm and were assigned a matched control cadet. Injury rates, numbers of visits to sick call, and numbers of days spent on medical excusal during a 1-year period were then compared for the 252 cadets. There was no difference in prevalence of injury between the groups and no significant differences (p > 0.05) between the groups in injury rates, visits to sick call, or number of days spent on medical excusal. These findings do not support any increased incidence of injuries in a young, healthy, athletic, military population with mild LLIs, compared with matched control subjects without LLIs, over 1 year.

  5. 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

    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......) a parts per thousand yenaEuro parts per thousand 0.91, p a parts per thousand currency signaEuro parts per thousand 1 x 10(-5)). Across the seven centres, the C-statistic for distinguishing HNF1A-MODY from young adult-onset type 2 diabetes ranged from 0.79 to 0.97, indicating high discriminative accuracy...

  6. Surgical timing after chemoradiotherapy for rectal cancer, analysis of technique (STARRCAT): results of a feasibility multi-centre randomized controlled trial.

    Science.gov (United States)

    Foster, J D; Ewings, P; Falk, S; Cooper, E J; Roach, H; West, N P; Williams-Yesson, B A; Hanna, G B; Francis, N K

    2016-10-01

    The optimal time of rectal resection after long-course chemoradiotherapy (CRT) remains unclear. A feasibility study was undertaken for a multi-centre randomized controlled trial evaluating the impact of the interval after chemoradiotherapy on the technical complexity of surgery. Patients with rectal cancer were randomized to either a 6- or 12-week interval between CRT and surgery between June 2012 and May 2014 (ISRCTN registration number: 88843062). For blinded technical complexity assessment, the Observational Clinical Human Reliability Analysis technique was used to quantify technical errors enacted within video recordings of operations. Other measured outcomes included resection completeness, specimen quality, radiological down-staging, tumour cell density down-staging and surgeon-reported technical complexity. Thirty-one patients were enrolled: 15 were randomized to 6 and 16-12 weeks across 7 centres. Fewer eligible patients were identified than had been predicted. Of 23 patients who underwent resection, mean 12.3 errors were observed per case at 6 weeks vs. 10.7 at 12 weeks (p = 0.401). Other measured outcomes were similar between groups. The feasibility of measurement of operative performance of rectal cancer surgery as an endpoint was confirmed in this exploratory study. Recruitment of sufficient numbers of patients represented a challenge, and a proportion of patients did not proceed to resection surgery. These results suggest that interval after CRT may not substantially impact upon surgical technical performance.

  7. A complexity analysis of the Gauss-Bessel quadrature as applied to the evaluation of multi-centre integrals over STFs

    International Nuclear Information System (INIS)

    Bouferguene, Ahmed; Safouhi, Hassan

    2006-01-01

    In a previous work (Bouferguene 2005 J. Phys. A: Math. Gen. 38 3923), we have shown that in the framework of the Gaussian integral transform, multi-centre integrals over Slater type functions can be evaluated to an acceptable accuracy using a tailored Gauss quadrature in which the weight function has the form W(σ, τ; z) = z ν exp(-σz - τ/z). To be considered a solution worth implementing within a software for routine use in ab initio molecular simulations, the method must also prove to be at least as efficient as those methods previously published in the literature. Two major results are provided in this paper. Firstly, an improvement of the procedure used to generate the roots and weights of the Gauss-Bessel quadrature is proposed. Secondly, a computational cost analysis of the present method and the SD-bar (Safouhi 2001 J. Phys. A: Math. Gen. 34 2801) based approach are compared, hence proving the equivalence of the two from a complexity point of view

  8. 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.

  9. CoDuSe group exercise programme improves balance and reduces falls in people with multiple sclerosis: A multi-centre, randomized, controlled pilot study.

    Science.gov (United States)

    Carling, Anna; Forsberg, Anette; Gunnarsson, Martin; Nilsagård, Ylva

    2017-09-01

    Imbalance leading to falls is common in people with multiple sclerosis (PwMS). To evaluate the effects of a balance group exercise programme (CoDuSe) on balance and walking in PwMS (Expanded Disability Status Scale, 4.0-7.5). A multi-centre, randomized, controlled single-blinded pilot study with random allocation to early or late start of exercise, with the latter group serving as control group for the physical function measures. In total, 14 supervised 60-minute exercise sessions were delivered over 7 weeks. Pretest-posttest analyses were conducted for self-reported near falls and falls in the group starting late. Primary outcome was Berg Balance Scale (BBS). A total of 51 participants were initially enrolled; three were lost to follow-up. Post-intervention, the exercise group showed statistically significant improvement ( p = 0.015) in BBS and borderline significant improvement in MS Walking Scale ( p = 0.051), both with large effect sizes (3.66; -2.89). No other significant differences were found between groups. In the group starting late, numbers of falls and near falls were statistically significantly reduced after exercise compared to before ( p balance and reduced perceived walking limitations, compared to no exercise. The intervention reduced falls and near falls frequency.

  10. The cataract national data set electronic multi-centre audit of 55,567 operations: case-mix adjusted surgeon's outcomes for posterior capsule rupture.

    Science.gov (United States)

    Sparrow, J M; Taylor, H; Qureshi, K; Smith, R; Johnston, R L

    2011-08-01

    To develop a methodology for case-mix adjustment of surgical outcomes for individual cataract surgeons using electronically collected multi-centre data conforming to the cataract national data set (CND). Routinely collected anonymised data were remotely extracted from electronic patient record (EPR) systems in 12 participating NHS Trusts undertaking cataract surgery. Following data checks and cleaning, analyses were carried out to risk adjust outcomes for posterior capsule rupture rates for individual surgeons, with stratification by surgical grade. A total of 406 surgeons from 12 NHS Trusts submitted data on 55,567 cataract operations between November 2001 and July 2006 (86% from January 2004). In all, 283 surgeons contributed data on >25 cases, providing 54,319 operations suitable for detailed analysis. Case-mix adjusted results of individual surgeons are presented as funnel plots for all surgeons together, and separately for three different grades of surgeon. Plots include 95 and 99.8% confidence limits around the case-mix adjusted outcomes for detection of surgical outliers. Routinely collected electronic data conforming to the CND provides sufficient detail for case-mix adjustment of cataract surgical outcomes. The validation of these risk indicators should be carried out using fresh data to confirm the validity of the risk model. Once validated this model should provide an equitable approach for peer-to-peer comparisons in the context of revalidation.

  11. Large multi-centre pilot randomized controlled trial testing a low-cost, tailored, self-help smoking cessation text message intervention for pregnant smokers (MiQuit).

    Science.gov (United States)

    Naughton, Felix; Cooper, Sue; Foster, Katharine; Emery, Joanne; Leonardi-Bee, Jo; Sutton, Stephen; Jones, Matthew; Ussher, Michael; Whitemore, Rachel; Leighton, Matthew; Montgomery, Alan; Parrott, Steve; Coleman, Tim

    2017-07-01

    To estimate the effectiveness of pregnancy smoking cessation support delivered by short message service (SMS) text message and key parameters needed to plan a definitive trial. Multi-centre, parallel-group, single-blinded, individual randomized controlled trial. Sixteen antenatal clinics in England. Four hundred and seven participants were randomized to the intervention (n = 203) or usual care (n = 204). Eligible women were 5 pre-pregnancy), were able to receive and understand English SMS texts and were not already using text-based cessation support. All participants received a smoking cessation leaflet; intervention participants also received a 12-week programme of individually tailored, automated, interactive, self-help smoking cessation text messages (MiQuit). Seven smoking outcomes, including validated continuous abstinence from 4 weeks post-randomization until 36 weeks gestation, design parameters for a future trial and cost-per-quitter. Using the validated, continuous abstinence outcome, 5.4% (11 of 203) of MiQuit participants were abstinent versus 2.0% (four of 204) of usual care participants [odds ratio (OR) = 2.7, 95% confidence interval (CI) = 0.93-9.35]. The Bayes factor for this outcome was 2.23. Completeness of follow-up at 36 weeks gestation was similar in both groups; provision of self-report smoking data was 64% (MiQuit) and 65% (usual care) and abstinence validation rates were 56% (MiQuit) and 61% (usual care). The incremental cost-per-quitter was £133.53 (95% CI = -£395.78 to 843.62). There was some evidence, although not conclusive, that a text-messaging programme may increase cessation rates in pregnant smokers when provided alongside routine NHS cessation care. © 2017 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

  12. Radiological and pathological findings of interval cancers in a multi-centre, randomized, controlled trial of mammographic screening in women from age 40-41 years

    International Nuclear Information System (INIS)

    Evans, A.J.; Kutt, E.; Record, C.; Waller, M.; Bobrow, L.; Moss, S.

    2007-01-01

    Aim: The aim of this study was to analyse the radiographic findings of the screening mammograms of women with interval cancer who participated in a multi-centre, randomized, controlled trial of mammographic screening in women from age 40-48 years. Materials and methods: The screening and diagnostic mammograms of 208 women with interval cancers were reviewed. Abnormalities were classified as malignant, subtle and non-specific. Results: Eighty-seven (42%) of women had true, 66 (32%) occult and 55 (26%) false-negative interval cancers. The features most frequently missed or misinterpreted were granular microcalcification (38%), asymmetric density (27%) and distortion (22%). Thirty-seven percent of abnormal previous screens were classified as malignant, 39% subtle change and 21% as non-specific. Granular calcifications were significantly more common on the diagnostic mammograms of false-negative interval cancers than those of true interval cancers (28 versus 14%, p = 0.04). Occult interval cancers were more likely to be <10 mm and <15 mm in invasive pathological size than other interval cancers (p = 0.03 and 0.005, respectively). True interval cancers were more likely to be histologically grade 3 than other interval cancers (p = 0.04). Women who developed true and false-negative interval cancers had similar background patterns, but women with occult cancers had a higher proportion of dense patterns (p < 0.05). Conclusion: Interval cancers in a young screening population have a high proportion of occult lesions that are small and occur in dense background patterns. The proportion of interval cancers that are false negative is similar that seen in older populations and granular microcalcification is the commonest missed mammographic feature

  13. Consent: an event or a memory in lumbar spinal surgery? A multi-centre, multi-specialty prospective study of documentation and patient recall of consent content.

    Science.gov (United States)

    Lo, William B; McAuley, Ciaran P; Gillies, Martin J; Grover, Patrick J; Pereira, Erlick A C

    2017-11-01

    Prospective, multi-centre, multi-specialty medical notes review and patient interview. The consenting process is an important communication tool which also carries medico-legal implications. While written consent is a pre-requisite before spinal surgery in the UK, the standard and effectiveness of the process have not been assessed previously. This study assesses standard of written consent for elective lumbar decompressive surgery for degenerative disc disease across different regions and specialties in the UK; level of patient recall of the consent content; and identifies factors which affect patient recall. Consent forms of 153 in-patients from 4 centres a, b, c, d were reviewed. Written documentation of intended benefits, alternative treatments and operative risks was assessed. Of them, 108 patients were interviewed within 24 h before or after surgeries to assess recall. The written documentation rates of the operative risks showed significant inter-centre variations in haemorrhage and sphincter disturbance (P = 0.000), but not for others. Analysis of pooled data showed variations in written documentation of risks (P recall of these risks, there was no inter-centre variation. Patients' recall of paralysis as a risk was highest (50.9%) and that of recurrence was lowest (6.5%). Patients recalled risks better than those ≥65, significantly so for infection (29.9 vs 9.7%, P = 0.027). Patients consented >14 days compared to recall for paralysis (65.2 vs 43.7%) and recurrence (17.4 vs 2.8%). Patient recall was independent of consenter grade. Overall, the standard of written consent for elective lumbar spinal decompressive surgery was sub-optimal, which was partly reflected in the poor patient recall. While consenter seniority did not affect patient recall, younger age and longer consent-to-surgery time improved it.

  14. Efficacy of night-time compression for breast cancer related lymphedema (LYNC): protocol for a multi-centre, randomized controlled efficacy trial

    International Nuclear Information System (INIS)

    McNeely, Margaret L.; Campbell, Kristin L.; Webster, Marc; Kuusk, Urve; Tracey, Karen; Mackey, John

    2016-01-01

    Lymphedema is a prevalent long-term effect of breast cancer treatment that is associated with reduced quality of life. More recent observational data suggest that the addition of night-time compression to day-time use of a compression garment results in better long-term control of arm lymphedema. The primary objectives of the randomized controlled phase of the trial are to determine the efficacy of night-time compression on arm lymphedema volume maintenance and quality of life in breast cancer survivors who have completed intensive reduction treatment for their lymphedema. The study will be a parallel 3-arm, multi-centre randomized fast-track trial. A total of 120 women with breast cancer related lymphedema will be recruited from 3 centres in Canada and randomized to group 1: Day-time compression garment alone or Group 2: Day-time compression garment + night-time compression bandaging or Group 3: Day-time compression garment + use of a night-time compression system garment. The duration of the primary intervention period will be 12 weeks. The follow-up period after the intervention (weeks 13 to 24) will follow a longitudinal observational design. The primary outcome variables: differences from baseline to week 12 in arm volume and quality of life (Lymphoedema Functioning, Disability and Health Questionnaire: Lymph-ICF). Secondary outcomes include bioimpedance analysis, sleep disturbance and self-efficacy. All measurements are standardized and will be performed prior to randomization, and at weeks 6, 12, 18 and 24. The use of night-time compression as a self-management strategy for chronic breast cancer related lymphedema is seen as an innovative approach to improve long-term control over the condition. This trial aims to advance the knowledge on self-management strategies for lymphedema

  15. ASAP ECMO: Antibiotic, Sedative and Analgesic Pharmacokinetics during Extracorporeal Membrane Oxygenation: a multi-centre study to optimise drug therapy during ECMO

    Directory of Open Access Journals (Sweden)

    Shekar Kiran

    2012-11-01

    Full Text Available Abstract Background Given the expanding scope of extracorporeal membrane oxygenation (ECMO and its variable impact on drug pharmacokinetics as observed in neonatal studies, it is imperative that the effects of the device on the drugs commonly prescribed in the intensive care unit (ICU are further investigated. Currently, there are no data to confirm the appropriateness of standard drug dosing in adult patients on ECMO. Ineffective drug regimens in these critically ill patients can seriously worsen patient outcomes. This study was designed to describe the pharmacokinetics of the commonly used antibiotic, analgesic and sedative drugs in adult patients receiving ECMO. Methods/Design This is a multi-centre, open-label, descriptive pharmacokinetic (PK study. Eligible patients will be adults treated with ECMO for severe cardiac and/or respiratory failure at five Intensive Care Units in Australia and New Zealand. Patients will receive the study drugs as part of their routine management. Blood samples will be taken from indwelling catheters to investigate plasma concentrations of several antibiotics (ceftriaxone, meropenem, vancomycin, ciprofloxacin, gentamicin, piperacillin-tazobactum, ticarcillin-clavulunate, linezolid, fluconazole, voriconazole, caspofungin, oseltamivir, sedatives and analgesics (midazolam, morphine, fentanyl, propofol, dexmedetomidine, thiopentone. The PK of each drug will be characterised to determine the variability of PK in these patients and to develop dosing guidelines for prescription during ECMO. Discussion The evidence-based dosing algorithms generated from this analysis can be evaluated in later clinical studies. This knowledge is vitally important for optimising pharmacotherapy in these most severely ill patients to maximise the opportunity for therapeutic success and minimise the risk of therapeutic failure. Trial registration ACTRN12612000559819

  16. Phlebitis risk varies by peripheral venous catheter site and increases after 96 hours: a large multi-centre prospective study.

    Science.gov (United States)

    Cicolini, Giancarlo; Manzoli, Lamberto; Simonetti, Valentina; Flacco, Maria Elena; Comparcini, Dania; Capasso, Lorenzo; Di Baldassarre, Angela; Eltaji Elfarouki, Ghaleb

    2014-11-01

    This multi-centre prospective field study evaluated whether peripheral venous catheter site of insertion influences the risk of catheter-related phlebitis. Potential predictors of phlebitis were also investigated. Millions of patients worldwide use peripheral venous catheters, which frequently cause local complications including phlebitis, infection and obstruction. Although phlebitis predictors have been broadly investigated, uncertainties remain on the potential effect of cannulation anatomical site, duration and the appropriate time for catheter removal. A prospective cohort design was carried out from January-June 2012. The clinical course of each patient who received a new peripheral venous catheter for any cause in five Italian hospitals was followed by trained nurses until catheter removal. The presence of phlebitis was assessed every 24 hours using the Visual Infusion Phlebitis score. Analyses were based upon multilevel mixed-effects regression. The final sample consisted of 1498 patients. The average time for catheters in situ was 65·6 hours and 23·6% of the catheters were in place beyond 96 hours. Overall phlebitis incidence was 15·4%, 94·4% of which were grade 1. The likelihood of phlebitis independently increased with increasing catheter duration, being highest after 96 hours. Compared with patients with catheter placed in the dorsum of the hand (22·8% of the sample), those with the catheter located in the antecubital fossa (34·1%) or forearm were less likely to have a phlebitis of any grade. Antecubital fossa and forearm veins may be preferential sites for peripheral venous cannulation. Our results support Centers for Disease Control and Prevention recommendations to replace catheters in adults no later than 96 hours. A relevant proportion of healthcare personnel did not adhere to such guidelines - more attention to this issue is required. © 2014 John Wiley & Sons Ltd.

  17. An investigation into the opportunities and barriers to participation in a radiographer comment scheme, in a multi-centre NHS trust

    International Nuclear Information System (INIS)

    Lancaster, Anne; Hardy, Maryann

    2012-01-01

    Introduction and purpose: Despite the United Kingdom College of Radiographers aspiration that first line reporting or commenting by radiographers be normal practice, radiographers have not as yet embraced these opportunities in clinical practice and the number of radiographer commenting (initial reporting) schemes in operation is currently limited. This study explores radiographer opinion with regard to commenting with the aim of establishing the perceived opportunities and barriers to operating a commenting scheme with respect to trauma radiography. Method: A survey of 79 radiographers working within a single multi-centre Trust in the north of England was undertaken using a questionnaire. Attitudinal statements were used to elicit information on perceived opportunities and barriers to the implementation of radiographer commenting. Results: Fifty three questionnaires were returned within the specified time frame (n-53/79; 67.1%). A number of barriers to implementing a commenting scheme were identified including time, technology, anatomical confidence and training. Opportunities included improving professional profile and increased professional contribution to decision making within the patient pathway. No correlation was demonstrated between respondent demographic and responses suggesting that opinions expressed were not influenced by hospital site, radiographer grade or years experience. Conclusion: Radiographers generally had a positive attitude towards the implementation of radiographer commenting and felt that their operation was both beneficial to patient care and the professional profile of radiographers. However, a number of barriers were identified and while concerns regarding training may be increasingly addressed by the Department of Health’s e-learning image interpretation package, the impact of changes in technology and subsequent service operation have not yet been fully evaluated.

  18. Validation of the 24-item recovery assessment scale-revised (RAS-R) in the Norwegian language and context: a multi-centre study.

    Science.gov (United States)

    Biringer, Eva; Tjoflåt, Marit

    2018-01-25

    The Recovery Assessment Scale-revised (RAS-R) is a self-report instrument measuring mental health recovery. The purpose of the present study was to translate and adapt the RAS-R into the Norwegian language and to investigate its psychometric properties in terms of factor structure, convergent and discriminant validity and reliability in the Norwegian context. The present study is a cross-sectional multi-centre study. After a pilot test, the Norwegian version of the RAS-R was distributed to 231 service users in mental health specialist and community services. The factor structure of the instrument was investigated by a confirmatory factor analysis (CFA), and internal consistency was assessed by Cronbach's alpha. The RAS-R was found to be acceptable and feasible for service users. The original five-factor structure was confirmed. All model fit indices, including the standardised root mean square residual (SRMR), which is independent of the χ 2 -test, met the criteria for an acceptable model fit. Internal consistencies within sub-scales as measured by Cronbach's alpha ranged from 0.65 to 0.85. Cronbach's alpha for the total scale was 0.90. As expected, some redundancy between factors existed (in particular among the factors Personal confidence and hope, Goal and success orientation and Not dominated by symptoms). The Norwegian RAS-R showed acceptable psychometric properties in terms of convergent validity and reliability, and fit indices from the CFA confirmed the original factor structure. We recommend the Norwegian RAS-R as a tool in service users' and health professionals' collaborative work towards the service users' recovery goals and as an outcome measure in larger evaluations.

  19. Percutaneous Isolated Hepatic Perfusion as a Treatment for Isolated Hepatic Metastases of Uveal Melanoma: Patient Outcome and Safety in a Multi-centre Study

    Energy Technology Data Exchange (ETDEWEB)

    Vogl, Thomas J., E-mail: t.vogl@em.uni-frankfurt.de; Koch, Silvia A., E-mail: silvia.koch@web.de [University Hospital Frankfurt, Department of Diagnostic and Interventional Radiology (Germany); Lotz, Gösta, E-mail: goesta.lotz@kgu.de [University Hospital Frankfurt, Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy (Germany); Gebauer, Bernhard, E-mail: bernhard.gebauer@charite.de [Universitätsmedizin Berlin, Department of Diagnostic and Interventional Radiology, Campus Charité Mitte (Germany); Willinek, Winfried, E-mail: w.willinek@bk-trier.de [Brüderkrankenhaus Trier, Department of Diagnostic and Interventional Radiology (Germany); Engelke, Christoph, E-mail: engelke@ekweende.de [Evangelisches Krankenhaus Göttingen-Weende gGmbH, Department of Diagnostic and Interventional Radiology (Germany); Brüning, Roland, E-mail: r.bruening@asklepios.com; Zeile, Martin, E-mail: m.zeile@asklepios.com [Asklepios Klinik Barmbek, Department of Diagnostic and Interventional Radiology (Germany); Wacker, Frank, E-mail: wacker.frank@mh-hannover.de [Medizinische Hochschule Hannover, Department of Diagnostic and Interventional Radiology (Germany); Vogel, Arndt, E-mail: vogel.arndt@mh-hannover.de [Medizinische Hochschule Hannover, Department of Gastroenterology, Hepatology and Endocrinology (Germany); Radeleff, Boris, E-mail: boris.radeleff@med.uni-heidelberg.de [Heidelberg University Hospital, Department of Diagnostic and Interventional Radiology (Germany); Scholtz, Jan-Erik, E-mail: janerikscholtz@gmail.com [University Hospital Frankfurt, Department of Diagnostic and Interventional Radiology (Germany)

    2017-06-15

    PurposePercutaneous isolated hepatic perfusion (PIHP) with Melphalan has been developed as a treatment for patients with isolated hepatic metastases of uveal melanoma. We discuss patient outcome and safety in a retrospective multi-centre study.Materials and MethodsBetween 2012 and 2016 18 patients with un-resectable isolated hepatic metastases of uveal melanoma received single or repeated PIHP with Melphalan (n = 35) at seven sites. Progression-free time, overall survival time (OS) and tumour response by means of RECIST 1.1 criteria were evaluated. Peri- and post-procedural adverse events (AE) were registered. Patients’ life quality was assessed using four-point scale questionnaires.ResultsOf 18 patients, initial PIHP treatment resulted in partial response (PR) in eight, stable disease (SD) in seven and progressive disease (PD) in three cases. Nine patients underwent second PIHP with PR in eight cases and PD in one case. Six patients were evaluated after third PIHP with PR in five patients and SD in one patient. Two patients received fourth PIHP with PD in both cases. Median OS was 9.6 months (range 1.6–41.0 months). Median progression-free survival time was 12.4 months (range 0.9–41.0 months) with 1-year survival of 44%. Most common post-procedural AE grade 3 and 4 were temporary leukopenia (n = 11) and thrombocytopenia (n = 8). Patients’ self-assessments showed good ratings for overall health and quality of life with only slight changes after PIHP, and a high degree of satisfaction with PIHP treatment.ConclusionPIHP with Melphalan proved to be a relatively safe, minimal-invasive and repeatable treatment for patients with non-resectable hepatic metastases of uveal melanoma.

  20. Percutaneous Isolated Hepatic Perfusion as a Treatment for Isolated Hepatic Metastases of Uveal Melanoma: Patient Outcome and Safety in a Multi-centre Study

    International Nuclear Information System (INIS)

    Vogl, Thomas J.; Koch, Silvia A.; Lotz, Gösta; Gebauer, Bernhard; Willinek, Winfried; Engelke, Christoph; Brüning, Roland; Zeile, Martin; Wacker, Frank; Vogel, Arndt; Radeleff, Boris; Scholtz, Jan-Erik

    2017-01-01

    PurposePercutaneous isolated hepatic perfusion (PIHP) with Melphalan has been developed as a treatment for patients with isolated hepatic metastases of uveal melanoma. We discuss patient outcome and safety in a retrospective multi-centre study.Materials and MethodsBetween 2012 and 2016 18 patients with un-resectable isolated hepatic metastases of uveal melanoma received single or repeated PIHP with Melphalan (n = 35) at seven sites. Progression-free time, overall survival time (OS) and tumour response by means of RECIST 1.1 criteria were evaluated. Peri- and post-procedural adverse events (AE) were registered. Patients’ life quality was assessed using four-point scale questionnaires.ResultsOf 18 patients, initial PIHP treatment resulted in partial response (PR) in eight, stable disease (SD) in seven and progressive disease (PD) in three cases. Nine patients underwent second PIHP with PR in eight cases and PD in one case. Six patients were evaluated after third PIHP with PR in five patients and SD in one patient. Two patients received fourth PIHP with PD in both cases. Median OS was 9.6 months (range 1.6–41.0 months). Median progression-free survival time was 12.4 months (range 0.9–41.0 months) with 1-year survival of 44%. Most common post-procedural AE grade 3 and 4 were temporary leukopenia (n = 11) and thrombocytopenia (n = 8). Patients’ self-assessments showed good ratings for overall health and quality of life with only slight changes after PIHP, and a high degree of satisfaction with PIHP treatment.ConclusionPIHP with Melphalan proved to be a relatively safe, minimal-invasive and repeatable treatment for patients with non-resectable hepatic metastases of uveal melanoma.

  1. The impact of PET-CT in suspected recurrent ovarian cancer: A prospective multi-centre study as part of the Australian PET Data Collection Project.

    Science.gov (United States)

    Fulham, M J; Carter, J; Baldey, A; Hicks, R J; Ramshaw, J E; Gibson, M

    2009-03-01

    To assess the impact of FDG PET-CT on the management of patients with suspected recurrent ovarian cancer and to determine the incremental information provided by PET-CT. This was a prospective, multi-centre, cohort study. Ninety women (mean age 59.9 years; age range 35-85 years) with a previous history of treated epithelial ovarian carcinoma and suspected recurrence based on elevated CA-125, anatomical imaging or clinical symptoms were studied with FDG PET-CT across two States. Referring doctors were asked to specify a management plan pre-PET, if management was altered after PET-CT and, the impact (rated - none, low, medium, high) of PET-CT on patient management. The pre-PET management plan could include radiotherapy, chemotherapy, surgery, and 'other' including observation. Patients were followed at 6 and 12 months and clinical status, evidence of recurrence and progression were recorded. Patients were referred by 34 individual specialists. At least 168 additional sites of disease in 61 patients (68%), not identified by conventional imaging were identified by PET-CT. In 77% the additional lesions were located below the diaphragm and most were nodal or peritoneal. PET-CT affected management in 60% (49% high, 11% medium impact). Patients where more disease was detected with PET-CT were more likely to progress in the following 12 months. For women with previously treated ovarian carcinoma with recurrent disease, PET-CT can: a) alter management in close to 60% of patients, b) detect more sites of disease than abdominal and pelvic CT, c) is superior in the detection of nodal, peritoneal and subcapsular liver disease and d) offers the opportunity for technology replacement in this setting.

  2. Relationship between Anthropometric Factors and Ability of Standing Long-Jump Among Track and Field Cadet Athletes

    Directory of Open Access Journals (Sweden)

    Meysam Gholamali

    2012-10-01

    Full Text Available From the most important factors that involved in success of sport disciplines, we can note to physiolological, psychological and specific given anthropometric factors of these disciplines [1]. In turn, a few studies have been done about the amount of relationship and strength of anthropometric factors in success prediction, athletes advising about continue given sport discipline in childhood and talent identification. Therefore, the aim of this study was to investigate the relationship between some anthropometric factors and ability of standing long-jump (ASLJ among track and field cadet athletes. Thirty-four cadets (Age=10.03±2.90 that regularly performed track and field training participated in this study. Height, waist to hip ratio (WHR and weight measured by flexible tape and digital Scale, respectively. BMI calculated by weight/height [2].

  3. Fatores de risco cardiovascular e consumo alimentar em cadetes da Academia da Força Aérea Brasileira

    Directory of Open Access Journals (Sweden)

    Fernanda Elisabete Hilgenberg

    2016-04-01

    Full Text Available Resumo O objetivo deste artigo é investigar a prevalência de fatores de risco cardiovascular e inadequações de consumo alimentar em cadetes da Academia da Força Aérea Brasileira e a associação com sexo e ano de formação. Estudo transversal com 166 cadetes da Academia da Força Aérea Brasileira, em Pirassununga – SP, entre junho e dezembro de 2013. Foram avaliadas medidas antropométricas, parâmetros bioquímicos e clínicos, nível de atividade física, tabagismo e consumo alimentar. Testes de Qui-Quadrado de Pearson ou Exato de Fisher foram utilizados. A prevalência de excesso de peso (IMC >25,0 kg/m2 foi de 29,7% nos homens e de 16,7% nas mulheres. Hipertensão arterial foi prevalente em 15,2% dos homens. Verificou-se hipercolesterolemia em 50,7% dos cadetes; 24,3% apresentaram valores elevados de lipoproteína de baixa densidade e, 11,2%, lipoproteína de alta densidade baixa. Houve associação entre tempo de permanência na Academia e lipoproteína de alta densidade baixa. Observou-se consumo elevado de gorduras saturadas (87,2% e de colesterol (42,7%. A ingestão inadequada de fibras foi verificada em 92,7% da amostra. Observou-se considerável prevalência de fatores de risco cardiovascular entre os cadetes, principalmente hipercolesterolemia e consumo alimentar inadequado.

  4. 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.

  5. 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.

  6. Accuracy of Bioelectrical Impedance Analysis in Estimated Longitudinal Fat-Free Mass Changes in Male Army Cadets.

    Science.gov (United States)

    Langer, Raquel D; Matias, Catarina N; Borges, Juliano H; Cirolini, Vagner X; Páscoa, Mauro A; Guerra-Júnior, Gil; Gonçalves, Ezequiel M

    2018-03-26

    Bioelectrical impedance analysis (BIA) is a practical and rapid method for making a longitudinal analysis of changes in body composition. However, most BIA validation studies have been performed in a clinical population and only at one moment, or point in time (cross-sectional study). The aim of this study is to investigate the accuracy of predictive equations based on BIA with regard to the changes in fat-free mass (FFM) in Brazilian male army cadets after 7 mo of military training. The values used were determined using dual-energy X-ray absorptiometry (DXA) as a reference method. The study included 310 male Brazilian Army cadets (aged 17-24 yr). FFM was measured using eight general predictive BIA equations, with one equation specifically applied to this population sample, and the values were compared with results obtained using DXA. The student's t-test, adjusted coefficient of determination (R2), standard error of estimation (SEE), Lin's approach, and the Bland-Altman test were used to determine the accuracy of the predictive BIA equations used to estimate FFM in this population and between the two moments (pre- and post-moment). The FFM measured using the nine predictive BIA equations, and determined using DXA at the post-moment, showed a significant increase when compared with the pre-moment (p FFM changes in the army cadets between the two moments in a very similar way to the reference method (DXA). However, only the one BIA equation specific to this population showed no significant differences in the FFM estimation between DXA at pre- and post-moment of military routine. All predictive BIA equations showed large limits of agreement using the Bland-Altman approach. The eight general predictive BIA equations used in this study were not found to be valid for analyzing the FFM changes in the Brazilian male army cadets, after a period of approximately 7 mo of military training. Although the BIA equation specific to this population is dependent on the amount of

  7. Efficacy and safety of artemisinin-naphthoquine versus dihydroartemisinin-piperaquine in adult patients with uncomplicated malaria: a multi-centre study in Indonesia

    Directory of Open Access Journals (Sweden)

    Tjitra Emiliana

    2012-06-01

    Full Text Available Abstract Background A practical and simple regimen for all malaria species is needed towards malaria elimination in Indonesia. It is worth to compare the efficacy and safety of a single dose of artemisinin-naphthoquine (AN with a three-day regimen of dihydroartemisinin-piperaquine (DHP, the existing programme drug, in adults with uncomplicated symptomatic malaria. Methods This is a phase III, randomized, open label using sealed envelopes, multi-centre, comparative study between a single dose of AN and a three-day dose of DHP in Jayapura and Maumere. The modified WHO inclusion and exclusion criteria for efficacy study were used in this trial. A total of 401 eligible adult malaria subjects were hospitalized for three days and randomly treated with AN four tablets single dose on day 0 or DHP three to four tablets single daily dose for three days, and followed for 42 days for physical examination, thick and thin smears microscopy, and other necessary tests. The efficacy of drug was assessed by polymerase chain reaction (PCR uncorrected and corrected. Results There were 153 Plasmodium falciparum, 158 Plasmodium vivax and 90 P. falciparum/P. vivax malaria. Mean of fever clearance times were similar, 13.0 ± 10.3 hours in AN and 11.3 ± 7.3 hours in DHP groups. The mean of parasite clearance times were longer in AN compared with DHP (28.0 ± 11.7 hours vs 25.5 ± 12.2 hours, p = 0.04. There were only 12 PCR-corrected P. falciparum late treatment failures: seven in AN and five in DHP groups. The PCR uncorrected and corrected on day −42 of adequate clinical and parasitological responses for treatment of any malaria were 93.7% (95% Cl: 90.3–97.2 and 96.3% (95% Cl: 93.6–99.0 in AN, 96.3% (95% Cl: 93.5–99.0 and 97.3% (95% Cl: 95.0–99.6 in DHP groups. Few and mild adverse events were reported. All the abnormal haematology and blood chemistry values had no clinical abnormality. Conclusion AN and DHP are confirmed very effective

  8. The impact of mild induced hypothermia on the rate of transfusion and the mortality in severely injured patients: a retrospective multi-centre study.

    Science.gov (United States)

    Jensen, Kai Oliver; Held, Leonhard; Kraus, Andrea; Hildebrand, Frank; Mommsen, Philipp; Mica, Ladislav; Wanner, Guido A; Steiger, Peter; Moos, Rudolf M; Simmen, Hans-Peter; Sprengel, Kai

    2016-10-06

    Although under discussion, induced hypothermia (IH) is an established therapy for patients with cardiac arrest or traumatic brain injuries. The influences on coagulopathy and bleeding tendency in severely injured patients (SIP) with concomitant traumatic brain injury are most widely unclear. Therefore, the aim of this study was to quantify the effect of mild IH in SIP with concomitant severe traumatic brain injuries on transfusion rate and mortality. In this retrospective multi-centre study, SIP from three European level-1 trauma centres with an ISS ≥16 between 2009 and 2011 were included. At hospital A, patients qualified for IH with age ≤70 years and a severe head injury with an abbreviated injury scale (AIS Head ) of ≥3. IH was defined as target core body temperature of 35 °C. Hypothermic patients were matched with two patients, one from hospital B and one from hospital C using age and AIS Head . The effect of IH on the transfusion rate, complications and mortality was quantified with 95 % confidence intervals (CI). Patients not treated with IH in hospital A and those from hospital B and C, who were not matched, were used to adjust the CI for the effect of inter-hospital therapy protocol differences. Mean age of patients in the IH-group (n = 43) was 35.7 years, mean ISS 30 points and sex distribution showed 83.7 % male. Mean age of matched patients in the normotherm-group (n = 86) was 36.7 years, mean ISS 33 points and there were 75.6 % males. For the hypothermic patients, we pointed out an estimate of mean difference for the number of transfused units of packed red blood cells as well as for mortality which does not indicate a decrease in the benefit gained by hypothermia. It is suggested that hypothermic patients tend to a higher rate of lung failure and thromboembolisms. Though tending to an increased rate of complications, there is no evidence for a difference in both; rate of transfusion and mortality in SIP. Mild IH as an option for

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

    Science.gov (United States)

    Brach, Michael; Nieder, Frank; Nieder, Ulrike; Mechling, Heinz

    2009-11-24

    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. 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 support (at the end of the project, and

  10. Undergraduate nursing students' performance in recognising and responding to sudden patient deterioration in high psychological fidelity simulated environments: an Australian multi-centre study.

    Science.gov (United States)

    Bogossian, Fiona; Cooper, Simon; Cant, Robyn; Beauchamp, Alison; Porter, Joanne; Kain, Victoria; Bucknall, Tracey; Phillips, Nicole M

    2014-05-01

    Early recognition and situation awareness of sudden patient deterioration, a timely appropriate clinical response, and teamwork are critical to patient outcomes. High fidelity simulated environments provide the opportunity for undergraduate nursing students to develop and refine recognition and response skills. This paper reports the quantitative findings of the first phase of a larger program of ongoing research: Feedback Incorporating Review and Simulation Techniques to Act on Clinical Trends (FIRST2ACTTM). It specifically aims to identify the characteristics that may predict primary outcome measures of clinical performance, teamwork and situation awareness in the management of deteriorating patients. Mixed-method multi-centre study. High fidelity simulated acute clinical environment in three Australian universities. A convenience sample of 97 final year nursing students enrolled in an undergraduate Bachelor of Nursing or combined Bachelor of Nursing degree were included in the study. In groups of three, participants proceeded through three phases: (i) pre-briefing and completion of a multi-choice question test, (ii) three video-recorded simulated clinical scenarios where actors substituted real patients with deteriorating conditions, and (iii) post-scenario debriefing. Clinical performance, teamwork and situation awareness were evaluated, using a validated standard checklist (OSCE), Team Emergency Assessment Measure (TEAM) score sheet and Situation Awareness Global Assessment Technique (SAGAT). A Modified Angoff technique was used to establish cut points for clinical performance. Student teams engaged in 97 simulation experiences across the three scenarios and achieved a level of clinical performance consistent with the experts' identified pass level point in only 9 (1%) of the simulation experiences. Knowledge was significantly associated with overall teamwork (p=.034), overall situation awareness (p=.05) and clinical performance in two of the three scenarios

  11. I-MOVE multi-centre case control study 2010-11: overall and stratified estimates of influenza vaccine effectiveness in Europe.

    Directory of Open Access Journals (Sweden)

    Esther Kissling

    Full Text Available BACKGROUND: In the third season of I-MOVE (Influenza Monitoring Vaccine Effectiveness in Europe, we undertook a multicentre case-control study based on sentinel practitioner surveillance networks in eight European Union (EU member states to estimate 2010/11 influenza vaccine effectiveness (VE against medically-attended influenza-like illness (ILI laboratory-confirmed as influenza. METHODS: Using systematic sampling, practitioners swabbed ILI/ARI patients within seven days of symptom onset. We compared influenza-positive to influenza laboratory-negative patients among those meeting the EU ILI case definition. A valid vaccination corresponded to > 14 days between receiving a dose of vaccine and symptom onset. We used multiple imputation with chained equations to estimate missing values. Using logistic regression with study as fixed effect we calculated influenza VE adjusting for potential confounders. We estimated influenza VE overall, by influenza type, age group and among the target group for vaccination. RESULTS: We included 2019 cases and 2391 controls in the analysis. Adjusted VE was 52% (95% CI 30-67 overall (N = 4410, 55% (95% CI 29-72 against A(H1N1 and 50% (95% CI 14-71 against influenza B. Adjusted VE against all influenza subtypes was 66% (95% CI 15-86, 41% (95% CI -3-66 and 60% (95% CI 17-81 among those aged 0-14, 15-59 and ≥60 respectively. Among target groups for vaccination (N = 1004, VE was 56% (95% CI 34-71 overall, 59% (95% CI 32-75 against A(H1N1 and 63% (95% CI 31-81 against influenza B. CONCLUSIONS: Results suggest moderate protection from 2010-11 trivalent influenza vaccines against medically-attended ILI laboratory-confirmed as influenza across Europe. Adjusted and stratified influenza VE estimates are possible with the large sample size of this multi-centre case-control. I-MOVE shows how a network can provide precise summary VE measures across Europe.

  12. 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

  13. A Study of the Language Learning Motivation of Saudi Military Cadets

    Directory of Open Access Journals (Sweden)

    Ali Falah Alqahtani

    2017-05-01

    Full Text Available Using Dörnyei’s  (2009 L2 Motivational Self System as the main theoretical framework, this paper reports a study of Saudi military cadets’ motivation to learn English. The study aimed to: a investigate the usefulness of Dörnyei’s model for understanding and explaining English language motivation in this global context; b capture other motivational factors seen to be relevant to the designated group’s motivation to learn English. A sample of 194 Saudi military cadets participated in the survey. Correlation and regression analysis of the data support the usefulness of the L2 Motivational Self System in assessing participants’ motivation to learn English. Language Learning Attitudes was found to be the best predictor of self-reported learning effort. In addition, Instrumentality Promotion and Instrumentality Prevention proved to be strong predictors of self-reported learning effort. Finally, the study hypothesised that a new construct ‘Religious Interest’ impacted on participants’ motivation to learn English, and regression analysis showed this was also a strong predictor of self-reported learning effort.

  14. DIFFERENCES IN EXPLOSIVE STRENGTH OF LEGS OF FOOTBALLERS OF CADET CATEGORIES

    Directory of Open Access Journals (Sweden)

    Nebojša Nedeljkov

    2011-09-01

    Full Text Available In structure football is very complicated and complex activity. Today's level of development of football game requires of players a high level and rhythm of the game, excellent physical condition, high technical standards in motion that depend on many motor skills. Various beginnings of movement, acceleration, stopping at high speed, changing direction, jumping, ball hitting are the most common movings in which explosive power of players is exhibited. Observing the activities of the game, players need most, the form of power, which is reflected in the shortest possible interval, ie. explosive strength. The study aims to determine the difference in explosive strength of legs of footballers of cadet category. The sample consisted of 60 players, divided into two groups of 30 subjects, aged 15 ± 1 years. One group was composed of Serbian national team and the other football players of FC ‘Vojvodina’ from Novi Sad. Sample tests consisted of six tests, as follows: running speed of 10 meters from a standing start, running speed 20 meters from a standing start, running speed 30 meters from a standing start, a jump up from the spot, standing long jump and triple jump. To examine whether statistically significant differences between groups of players we used t-test for two independent groups. Generally it can be concluded that there was a statistically significant difference between the two treatment groups of respondents in favor of the representatives of Serbi

  15. Multiple types of motives don't multiply the motivation of West Point cadets.

    Science.gov (United States)

    Wrzesniewski, Amy; Schwartz, Barry; Cong, Xiangyu; Kane, Michael; Omar, Audrey; Kolditz, Thomas

    2014-07-29

    Although people often assume that multiple motives for doing something will be more powerful and effective than a single motive, research suggests that different types of motives for the same action sometimes compete. More specifically, research suggests that instrumental motives, which are extrinsic to the activities at hand, can weaken internal motives, which are intrinsic to the activities at hand. We tested whether holding both instrumental and internal motives yields negative outcomes in a field context in which various motives occur naturally and long-term educational and career outcomes are at stake. We assessed the impact of the motives of over 10,000 West Point cadets over the period of a decade on whether they would become commissioned officers, extend their officer service beyond the minimum required period, and be selected for early career promotions. For each outcome, motivation internal to military service itself predicted positive outcomes; a relationship that was negatively affected when instrumental motives were also in evidence. These results suggest that holding multiple motives damages persistence and performance in educational and occupational contexts over long periods of time.

  16. Análisis de las acciones técnicas de los judokas cadetes participantes en el campeonato de España. (Analysis of technical actions of the judoist cadets participating in the judo championship of Spain.

    Directory of Open Access Journals (Sweden)

    Vicente Carratalá Deval

    2009-04-01

    Full Text Available ResumenEl entrenamiento del judoka dada su amplia estructura técnica, su dimensión táctica, su estructuración por categorías de peso y la incertidumbre creada por el adversario, muestra diversos y complejos aspectos a considerar, que deben ser analizados en situación real de competición. Desde esta perspectiva, la presente investigación tiene como objetivos identificar las características técnicas y tácticas de los judokas cadetes masculinos de nivel nacional, en cada una de las categorías de peso, a través del análisis de las acciones técnicas más utilizadas por los participantes en el campeonato de España de judo cadete. La muestra está formada por 128 judokas cadetes masculinos, de los que se analizaron 121 combates. Se realizó un estudio descriptivo con el análisis de las siguientes variables: las diferentes categorías de peso, las técnicas más utilizadas para la consecución de las ventajas técnicas y el minuto del combate en el que se produce la ventaja y las sanciones arbitrales. De los resultados se extrae que los judokas se caracterizan por utilizar en mayor medida las técnicas de te-waza, con un alto porcentaje de aplicación de seoi-nage y kata-guruma, seguidas por las técnicas de sutemi-waza y las técnicas de ashi-waza. Se obtienen un elevado número de ventajas técnicas mediante sanciones arbitrales por pasividad y falso ataque. En función del tiempo, es durante el primer y segundo minuto donde se producen el mayor número de ventajas técnicas, con predominio de las técnicas de tewaza y el sutemi-waza, acentuándose las ventajas por sanción arbitral en el segundo minuto. Abstract The training of the judoka, given its wide technical structure, its tactical dimension, its division into weight categories and the uncertainty created by the adversary, shows diverse and complex aspects to be considered and analyzed in real competitive situations. From this perspective, the objective of the present research

  17. Comparative Review of Endurance Development in Cadets and Students in Track-and-Field Classes and Training at Educational Institutions of State Emergency Service of Ukraine

    Directory of Open Access Journals (Sweden)

    В. М. Жогло

    2016-08-01

    Full Text Available The purpose of the research is to provide a comparative review of the endurance development in cadets and students in track-and-field classes and training at educational institutions of the State Emergency Service of Ukraine. Research methods: analysis of scientific and methodological literature, pedagogical testing and methods of mathematical statistics of data reduction. Research results. The study resulted in a comparative analysis of the levels of endurance development in the cadets and the first-year students of the School of Psychology and the School of Emergency Rescue Forces of the National University of Civil Defence of Ukraine. Conclusions. The study results prove that the first-year students of the School of Psychology and the School of Emergency Rescue Forces have a low level of endurance (special and aerobic as compared to the cadets. In this regard, the physical training syllabus ought to include more exercises intended to develop special and aerobic endurance.

  18. Study protocol, rationale and recruitment in a European multi-centre randomized controlled trial to determine the efficacy and safety of azithromycin maintenance therapy for 6 months in primary ciliary dyskinesia

    DEFF Research Database (Denmark)

    Kobbernagel, Helene Elgaard; Buchvald, Frederik F; Haarman, Eric G

    2016-01-01

    maintenance therapy in PCD. METHODS: The BESTCILIA trial is a European multi-centre, double-blind, randomized, placebo-controlled, parallel group study. The intervention is tablets of azithromycin 250/500 mg according to body weight or placebo administered three times a week for 6 months. Subjects...... prescribed in other chronic respiratory disorders. Furthermore, the trial will utilize the Lung clearance index and new, PCD-specific quality of life instruments as outcome measures for PCD. Recruitment is hampered by frequent occurrence of Pseudomonas aeruginosa infection, exacerbations at enrolment...

  19. Influence of the workplace on physical activity and cardiometabolic health: Results of the multi-centre cross-sectional Champlain Nurses' study.

    Science.gov (United States)

    Reed, Jennifer L; Prince, Stephanie A; Pipe, Andrew L; Attallah, Suzanne; Adamo, Kristi B; Tulloch, Heather E; Manuel, Douglas; Mullen, Kerri-Anne; Fodor, George; Reid, Robert D

    2018-02-13

    Nurses are the largest professional group within the health care workforce, and their work is perceived as being physically demanding. Regular physical activity helps to prevent or ameliorate cardiometabolic conditions (e.g. cardiovascular disease, diabetes). It is not known whether Canadian nurses are meeting current physical activity guidelines. To assess the influence of the workplace on the physical activity and cardiometabolic health of nurses from hospitals in the Champlain region of Ontario, Canada. A multi-centre, cross-sectional study. Hospitals in the Champlain Local Health Integration Network of Ontario. Nurses wore an ActiGraph accelerometer to objectively assess levels of moderate-to-vigorous intensity physical activity measured in minutes/day in bouts ≥10 min. All completed the Perceived Workplace Environment (PWE) scale and International Physical Activity Questionnaire (IPAQ). Height, body mass, waist circumference, blood pressure and heart rate were measured, and body mass index (BMI) was determined. Each nurse's 5-year cardiovascular risk was calculated using the Harvard Score. A total of 410 nurses (94% female; mean ± SD: age = 43 ± 12 years) from 14 hospitals participated. Nurses spent an average of 96 ± 100 min/week in bouts ≥10 min of moderate-to-vigorous intensity physical activity; 23% of nurses met recommended physical activity guidelines. Nurses working 8- vs. 12-h shifts (16 ± 16 vs. 10 ± 11 min/day, p = 0.026), fixed vs. rotating shifts (15 ± 15 vs. 12 ± 13 min/day, p = 0.012) and casual vs. full-time (29 ± 17 vs. 13 ± 15 min/day, p physical activity in bouts ≥10 min. The average PWE score was 2.4 ± 0.9, with no association between PWE scores and moderate-to-vigorous intensity physical activity in bouts ≥10 min (p > 0.05). Nurses working 8-h shifts, fixed shifts and in urban hospitals reported better PWE scores (p physical activity guidelines

  20. 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

  1. A multi-centre clinical follow-up database as a systematic approach to the evaluation of mid- and long-term health consequences in Chernobyl acute radiation syndrome patients

    International Nuclear Information System (INIS)

    Fischer, B.; Weiss, M.; Fliedner, T.M.; Belyi, D.A.; Kovalenko, A.N.; Bebeshko, V.G.; Nadejina, N.M.; Galstian, I.A.

    1996-01-01

    This paper describes scope, design and first results of a multi-centre follow-up database that has been established for the evaluation of mid- and long-term health consequences of acute radiation syndrome (ARS) survivors. After the Chernobyl accident on 26 April 1986, 237 cases with suspected acute radiation syndrome have been reported. For 134 of these cases the diagnosis of ARS was confirmed in a consensus conference three years after the accident. Nearly all survivors underwent regular follow-up examinations in two specialized centres in Kiev and in Moscow. In collaboration with these centres we established a multi-centre clinical follow-up database that records the results of the follow-up examinations in a standardized schema. This database is an integral part of a five step approach to patient evaluation and aims at a comprehensive base for scientific analysis of the mid- and long-term consequences of accidental ionizing radiation. It will allow for a dynamic view on the development of the health status of individuals and groups of patients as well as the identification of critical organ systems that need early support, and an improvement of acute and follow-up treatment protocols for radiation accident victims

  2. 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.

  3. 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)

    Hurkmans, Coen W; Cuijpers, Johan P; Lagerwaard, Frank J; Widder, Joachim; Heide, Uulke A van der; Schuring, Danny; Senan, Suresh

    2009-01-01

    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

  4. The structure of technical actions in the all-in wrestling on the example of Cadets' European Championships - Warsaw 2007

    Directory of Open Access Journals (Sweden)

    Kruchewskij A.

    2010-06-01

    Full Text Available Successive significant amendments to wrestling regulations made competitors and coaches adapt technical-tactical actions to the needs of the new situation of the fight. The main objective of the study is an analysis of the course of a wrestling match in events of the rank of the European championships allowing a determination of dominant technical actions of Greco-Roman wrestlers at the age of 14-16 years. 221 competitors from 33 countries took part in Cadets' European Championships in the Greco-Roman style in Warsaw. An analysis of technical actions comprised all offensive and defensive actions both in the standing and in the kneeling position during every round of the fight. In 255 fights athletes performed 1500 technical actions and tactical operations, for which they received 2891 points in total. A method of secondary direct observation was used for observation of the course of a wrestling match. During Cadets' European Championships athletes most often used the technique "taking down" in the standing position (13%, and the "cart" during the fight in the kneeling position (27%. Key words: combat sports, structure of a fight, Greco-Roman wrestling

  5. 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

  6. Cost-effectiveness of the Australian Medical Sheepskin for the prevention of pressure ulcers in somatic nursing home patients: study protocol for a prospective multi-centre randomised controlled trial (ISRCTN17553857).

    NARCIS (Netherlands)

    Mistiaen, P.; Achterberg, W.P.; Ament, A.; Halfen, R.; Huizinga, J.; Montgomery, K.; Post, H.; Francke, A.

    2008-01-01

    BACKGROUND: Pressure ulcers are a major problem, especially in nursing home patients, although they are regarded as preventable and there are many pressure relieving methods and materials. One such pressure relieving material is the recently developed Australian Medical Sheepskin, which has been

  7. 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

    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...

  8. 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.

  9. Cost-effectiveness of an integrated 'fast track' rehabilitation service for multi-trauma patients involving dedicated early rehabilitation intervention programs: design of a prospective, multi-centre, non-randomised clinical trial.

    NARCIS (Netherlands)

    Kosar, S.; Seelen, H.A.M.; Hemmen, B.; Evers, S.M.; Brink, P.R.

    2009-01-01

    ABSTRACT: BACKGROUND: In conventional multi-trauma care service (CTCS), patients are admitted to hospital via the accident & emergency room. After surgery they are transferred to the IC-unit followed by the general surgery ward. Ensuing treatment takes place in a hospital's outpatient clinic, a

  10. The effects of arthritis gloves on people with Rheumatoid Arthritis or Inflammatory Arthritis with hand pain: a study protocol for a multi-centre randomised controlled trial (the A-GLOVES trial).

    Science.gov (United States)

    Prior, Yeliz; Sutton, Chris; Cotterill, Sarah; Adams, Jo; Camacho, Elizabeth; Arafin, Nazina; Firth, Jill; O'Neill, Terence; Hough, Yvonne; Jones, Wendy; Hammond, Alison

    2017-05-30

    Arthritis gloves are regularly provided as part of the management of people with rheumatoid arthritis (RA) and undifferentiated (early) inflammatory arthritis (IA). Usually made of nylon and elastane (i.e. Lycra®), these arthritis gloves apply pressure with the aims of relieving hand pain, stiffness and improving hand function. However, a systematic review identified little evidence supporting their use. We therefore designed a trial to compare the effectiveness of the commonest type of arthritis glove provided in the United Kingdom (Isotoner gloves) (intervention) with placebo (control) gloves (i.e. larger arthritis gloves providing similar warmth to the intervention gloves but minimal pressure only) in people with these conditions. Participants aged 18 years and over with RA or IA and persistent hand pain will be recruited from National Health Service Trusts in the United Kingdom. Following consent, participants will complete a questionnaire booklet, then be randomly allocated to receive intervention or placebo arthritis gloves. Within three weeks, they will be fitted with the allocated gloves by clinical specialist rheumatology occupational therapists. Twelve weeks (i.e. the primary endpoint) after completing the baseline questionnaire, participants will complete a second questionnaire, including the same measures plus additional questions to explore adherence, benefits and problems with glove-wear. A sub-sample of participants from each group will be interviewed at the end of their participation to explore their views of the gloves received. The clinical effectiveness and cost-effectiveness of the intervention, compared to placebo gloves, will be evaluated over 12 weeks. The primary outcome measure is hand pain during activity. Qualitative interviews will be thematically analysed. This study will evaluate the commonest type of arthritis glove (Isotoner) provided in the NHS (i.e. the intervention) compared to a placebo glove. The results will help occupational therapists, occupational therapy services and people with arthritis make informed choices as to the value of arthritis gloves. If effective, arthritis gloves should become more widely available in the NHS to help people with RA and IA manage hand symptoms and improve performance of daily activities, work and leisure. If not, services can determine whether to cease supplying these to reduce service costs. ISRCTN Registry: ISRCTN25892131 Registered 05/09/2016.

  11. Comparison of Circumference Measures and Height-Weight Tables With Dual-Energy X-Ray Absorptiometry Assessment of Body Composition in R.O.T.C. Cadets.

    Science.gov (United States)

    Mitchell, Katherine M; Pritchett, Robert C; Gee, David L; Pritchett, Kelly L

    2017-09-01

    Mitchell, KM, Pritchett, RC, Gee, DL, and Pritchett, KL. Comparison of circumference measures and height-weight tables with dual-energy X-ray absorptiometry assessment of body composition in R.O.T.C. cadets. J Strength Cond Res 31(9): 2552-2556, 2017-Height-weight tables and circumference measures are used by the U.S. Army to predict body composition because they require little equipment or expertise. However, agreement between the Army's new 2002 circumference equation and an established laboratory technique has not been determined. The purpose of this study was to quantify agreement in body fat percentages between the Army's circumference measures (taping) and dual-energy X-ray absorptiometry (DXA); second to determine categorical agreement between height-weight tables and DXA. Male Reserve Officer Training Corps (R.O.T.C.) cadets (N = 23; 20.6 ± 1.6 years, 179.1 ± 6.6 cm; 81.4 ± 10.3 kg) were taped according to Army protocol to predict body fat. The % body fat prediction was compared with DXA through a Bland-Altman Plot with ±2-4% body fat established as a zone of agreement (ZOA). Thirteen out of 23 cadets fell outside the ZOA. No cadet was over the compliance threshold (20-22% fat) using the tape method, however, with DXA, 7 out of 23 cadets were noncompliant. Height-weight tables provided a moderate level of categorical agreement with DXA. The results depict poor agreement between taping and DXA, as taping generally underestimated % body fat. Compared with taping, height-weight tables were better able to identify excess fat weight.

  12. Physical Performance Measures of Flexibility, Hip Strength, Lower Limb Power and Trunk Endurance in Healthy Navy Cadets: Normative Data and Differences Between Sex and Limb Dominance.

    Science.gov (United States)

    Lopes, Thiago Jambo Alves; Simic, Milena; Alves, Daniel de Souza; Bunn, Priscila Dos Santos; Rodrigues, Allan Inoue; Terra, Bruno de Souza; Lima, Maicom da Silva; Ribeiro, Fabrício Miranda; Vilão, Patrick; Pappas, Evangelos

    2018-01-17

    The objectives were to provide normative data on commonly used physical performance tests that may be associated with musculoskeletal injuries in Navy cadets, and assess for sex and limb dominance differences. A large cohort of Navy cadets were assessed for physical performance tests of flexibility (ankle dorsiflexion range of motion and sit and reach), isometric hip strength, lower limb power (single leg hop), and trunk endurance (plank and side plank tests). Besides providing normative data tables, sex and limb dominance differences were assessed by a two-way mixed ANOVA. A total of 545 Brazilian Navy cadets (394 males) representing 79% of the cadets in the Academy participated. Normative reference values were reported as mean±SD, 95%CI and percentiles. For tests of muscle strength, power and endurance, males performed better than females (p<0.001). For flexibility tests, females achieved greater distances than males for the sit and reach test (p<0.001), but no difference for ankle dorsiflexion (p=0.51). Overall, there were no clinically relevant differences between limbs. In conclusion, normative data for commonly used physical performance tests were provided. Although no clinically relevant side-to-side differences were found, males presented higher values for lower limb strength and power, as well as trunk endurance than females, while females demonstrated increased flexibility. Valuable normative data are provided to professionals who work with young, active populations from the injury prevention or rehabilitation perspective; as the current study may help professionals to identify athletes or cadets whose performance is outside the normative values and may be at risk for injury.

  13. Supplemental parenteral nutrition in critically ill patients: a study protocol for a phase II randomised controlled trial.

    Science.gov (United States)

    Ridley, Emma J; Davies, Andrew R; Parke, Rachael; Bailey, Michael; McArthur, Colin; Gillanders, Lyn; Cooper, David J; McGuinness, Shay

    2015-12-24

    Nutrition is one of the fundamentals of care provided to critically ill adults. The volume of enteral nutrition received, however, is often much less than prescribed due to multiple functional and process issues. To deliver the prescribed volume and correct the energy deficit associated with enteral nutrition alone, parenteral nutrition can be used in combination (termed "supplemental parenteral nutrition"), but benefits of this method have not been firmly established. A multi-centre, randomised, clinical trial is currently underway to determine if prescribed energy requirements can be provided to critically ill patients by using a supplemental parenteral nutrition strategy in the critically ill. This prospective, multi-centre, randomised, stratified, parallel-group, controlled, phase II trial aims to determine whether a supplemental parenteral nutrition strategy will reliably and safely increase energy intake when compared to usual care. The study will be conducted for 100 critically ill adults with at least one organ system failure and evidence of insufficient enteral intake from six intensive care units in Australia and New Zealand. Enrolled patients will be allocated to either a supplemental parenteral nutrition strategy for 7 days post randomisation or to usual care with enteral nutrition. The primary outcome will be the average energy amount delivered from nutrition therapy over the first 7 days of the study period. Secondary outcomes include protein delivery for 7 days post randomisation; total energy and protein delivery, antibiotic use and organ failure rates (up to 28 days); duration of ventilation, length of intensive care unit and hospital stay. At both intensive care unit and hospital discharge strength and health-related quality of life assessments will be undertaken. Study participants will be followed up for health-related quality of life, resource utilisation and survival at 90 and 180 days post randomisation (unless death occurs first). This trial

  14. 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.

  15. Influence of quality of care and individual patient characteristics on quality of life and return to work in survivors of the acute respiratory distress syndrome: protocol for a prospective, observational, multi-centre patient cohort study (DACAPO).

    Science.gov (United States)

    Brandstetter, Susanne; Dodoo-Schittko, Frank; Blecha, Sebastian; Sebök, Philipp; Thomann-Hackner, Kathrin; Quintel, Michael; Weber-Carstens, Steffen; Bein, Thomas; Apfelbacher, Christian

    2015-12-17

    Health-related quality of life (HRQoL) and return to work are important outcomes in critical care medicine, reaching beyond mortality. Little is known on factors predictive of HRQoL and return to work in critical illness, including the acute respiratory distress syndrome (ARDS), and no evidence exists on the role of quality of care (QoC) for outcomes in survivors of ARDS. It is the aim of the DACAPO study ("Surviving ARDS: the influence of QoC and individual patient characteristics on quality of life") to investigate the role of QoC and individual patient characteristics on quality of life and return to work. A prospective, observational, multi-centre patient cohort study will be performed in Germany, using hospitals from the "ARDS Network Germany" as the main recruiting centres. It is envisaged to recruit 2400 patients into the DACAPO study and to analyse a study population of 1500 survivors. They will be followed up until 12 months after discharge from hospital. QoC will be assessed as process quality, structural quality and volume at the institutional level. The main outcomes (HRQoL and return to work) will be assessed by self-report questionnaires. Further data collection includes general medical and ARDS-related characteristics of patients as well as sociodemographic and psycho-social parameters. Multilevel hierarchical modelling will be performed to analyse the effects of QoC and individual patient characteristics on outcomes, taking the cluster structure of the data into account. By obtaining comprehensive data at patient and hospital level using a prospective multi-centre design, the DACAPO-study is the first study investigating the influence of QoC on individual outcomes of ARDS survivors.

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

    Directory of Open Access Journals (Sweden)

    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.

  17. Selection of Malaysia School Youth Cadet Corps leader by using analytical hierarchy process: A case study at SMK Ahmad Boestamam

    Science.gov (United States)

    Mohamed, Nurul Huda; Ahmat, Norhayati; Mohamed, Nurul Akmal; Razmi, Syazwani Che; Mohamed, Nurul Farihan

    2017-05-01

    This research is a case study to identify the best criteria that a person should have as the leader of Malaysia School Youth Cadet Corps (Kadet Remaja Sekolah (KRS)) at SMK Ahmad Boestamam, Sitiawan in order to select the most appropriate person to hold the position. The approach used in this study is Analytical Hierarchy Process (AHP) which include pairwise comparison to compare the criteria and also the candidates. There are four criteria namely charisma, interpersonal communication, personality and physical. Four candidates (1, 2, 3 and 4) are being considered in this study. Purposive sampling and questionnaires are used as instruments to obtain the data which are then analyzed by using the AHP method. The final output indicates that Candidate 1 has the highest score, followed by Candidate 2, Candidate 4 and Candidate 3. It shows that this method is very helpful in the multi-criteria decision making when there are several options available.

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

    Directory of Open Access Journals (Sweden)

    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

  19. Psychobiological Assessment and Enhancement of Team Cohesion and Psychological Resilience in ROTC Cadets Using a Virtual-Reality Team Cohesion Test

    Science.gov (United States)

    2016-06-01

    Using a Virtual - Reality Team Cohesion Test PRINCIPAL INVESTIGATOR: Josh Woolley MD/PhD CONTRACTING ORGANIZATION: NORTHERN CALIFORNIA INSTITUTE SAN...Team Cohesion and Psychological Resilience in ROTC Cadets Using a Virtual - Reality Team Cohesion Test 5b. GRANT NUMBER W81XWH-15-1-0042 5c. PROGRAM...targets while flying a virtual air vehicle. No individual has access to all the necessary information or controls, so operating as a team is crucial

  20. Increasing walking in patients with intermittent claudication: Protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    O'Carroll Ronan E

    2010-10-01

    Full Text Available Abstract Background People with intermittent claudication are at increased risk of death from heart attack and stroke compared to matched controls. Surgery for intermittent claudication is for symptom management and does not reduce the risk of cardiovascular morbidity and mortality. Increasing physical activity can reduce claudication symptoms and may improve cardiovascular health. This paper presents the pilot study protocol for a randomised controlled trial to test whether a brief psychological intervention leads to increased physical activity, improvement in quality of life, and a reduction in the demand for surgery, for patients with intermittent claudication. Methods/Design We aim to recruit 60 patients newly diagnosed with intermittent claudication, who will be randomised into two groups. The control group will receive usual care, and the treatment group will receive usual care and a brief 2-session psychological intervention to modify illness and walking beliefs and develop a walking action plan. The primary outcome will be walking, measured by pedometer. Secondary outcomes will include quality of life and uptake of surgery for symptom management. Participants will be followed up after (a 4 months, (b 1 year and (c 2 years. Discussion This study will assess the acceptability and efficacy of a brief psychological intervention to increase walking in patients with intermittent claudication, both in terms of the initiation, and maintenance of behaviour change. This is a pilot study, and the results will inform the design of a larger multi-centre trial. Trial Registration Current Controlled Trials ISRCTN28051878

  1. Metabolic manipulation in chronic heart failure: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Leon Francisco

    2011-06-01

    Full Text Available Abstract Background Heart failure is a major cause of morbidity and mortality in society. Current medical therapy centres on neurohormonal modulation with angiotensin converting enzyme inhibitors and β-blockers. There is growing evidence for the use of metabolic manipulating agents as adjunctive therapy in patients with heart failure. We aim to determine the effect of perhexiline on cardiac energetics and alterations in substrate utilisation in patients with non-ischaemic dilated cardiomyopathy. Methods A multi-centre, prospective, randomised double-blind, placebo-controlled trial of 50 subjects with non-ischaemic dilated cardiomyopathy recruited from University Hospital Birmingham NHS Foundation Trust and Cardiff and Vale NHS Trust. Baseline investigations include magnetic resonance spectroscopy to assess cardiac energetic status, echocardiography to assess left ventricular function and assessment of symptomatic status. Subjects are then randomised to receive 200 mg perhexiline maleate or placebo daily for 4 weeks with serum drug level monitoring. All baseline investigations will be repeated at the end of the treatment period. A subgroup of patients will undergo invasive investigations with right and left heart catheterisation to calculate respiratory quotient, and mechanical efficiency. The primary endpoint is an improvement in the phosphocreatine to adenosine triphosphate ratio at 4 weeks. Secondary end points are: i respiratory quotient; ii mechanical efficiency; iii change in left ventricular (LV function. Trial Registration ClinicalTrials.gov: NCT00841139 ISRCTN: ISRCTN2887836

  2. Evolución de la condición física en jugadoras de balonmano en las categorías infantil, cadete y juvenil

    Directory of Open Access Journals (Sweden)

    Helena Vila Suárez

    2007-03-01

    Full Text Available En la presente investigación se analiza la condición física de 91 jugadoras de balonmano, con edades comprendidas entre 13 y 18 años, distribuidas en tres categorías diferentes, infantil (n = 30, cadete (n = 32 y juvenil (n = 29. La investigación tiene carácter descriptivo y transversal. El principal objetivo es analizar la estructura condicional de las jugadoras. Para su valoración se aplicó la batería Eurofit, la batería de Bosco y test de Abalakov. Se encontraron diferencias significativas entre la categoría infantil-cadete en cinco de las 14 variables estudiadas, y ninguna entre la categoría cadete-juvenil. Los mejores resultados se produjeron en la categoría juvenil. En general, las restantes variables siempre alcanzaron mejores valores que la población escolar (en aquellas variables en las que la comparación fue posible, pero peores que los valores presentados por las jugadoras de las selecciones españolas. En las pruebas que valoraron la fuerza de tren inferior, los resultados indican que a mayor categoría las diferencias son menores entre categorías

  3. Hemicraniectomy after middle cerebral artery infarction with life-threatening Edema trial (HAMLET). Protocol for a randomised controlled trial of decompressive surgery in space-occupying hemispheric infarction.

    Science.gov (United States)

    Hofmeijer, Jeannette; Amelink, G Johan; Algra, Ale; van Gijn, Jan; Macleod, Malcolm R; Kappelle, L Jaap; van der Worp, H Bart

    2006-09-11

    Patients with a hemispheric infarct and massive space-occupying brain oedema have a poor prognosis. Despite maximal conservative treatment, the case fatality rate may be as high as 80%, and most survivors are left severely disabled. Non-randomised studies suggest that decompressive surgery reduces mortality substantially and improves functional outcome of survivors. This study is designed to compare the efficacy of decompressive surgery to improve functional outcome with that of conservative treatment in patients with space-occupying supratentorial infarction The study design is that of a multi-centre, randomised clinical trial, which will include 112 patients aged between 18 and 60 years with a large hemispheric infarct with space-occupying oedema that leads to a decrease in consciousness. Patients will be randomised to receive either decompressive surgery in combination with medical treatment or best medical treatment alone. Randomisation will be stratified for the intended mode of conservative treatment (intensive care or stroke unit care). The primary outcome measure will be functional outcome, as determined by the score on the modified Rankin Scale, at one year.

  4. Efficacy and safety of rasagiline as an adjunct to levodopa treatment in Chinese patients with Parkinson's disease: a randomized, double-blind, parallel-controlled, multi-centre trial.

    Science.gov (United States)

    Zhang, Lina; Zhang, Zhiqin; Chen, Yangmei; Qin, Xinyue; Zhou, Huadong; Zhang, Chaodong; Sun, Hongbin; Tang, Ronghua; Zheng, Jinou; Yi, Lin; Deng, Liying; Li, Jinfang

    2013-08-01

    Rasagiline mesylate is a highly potent, selective and irreversible monoamine oxidase type B (MAOB) inhibitor and is effective as monotherapy or adjunct to levodopa for patients with Parkinson's disease (PD). However, few studies have evaluated the efficacy and safety of rasagiline in the Chinese population. This study was designed to investigate the safety and efficacy of rasagiline as adjunctive therapy to levodopa treatment in Chinese PD patients. This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre trial conducted over a 12-wk period that enrolled 244 PD patients with motor fluctuations. Participants were randomly assigned to oral rasagiline mesylate (1 mg) or placebo, once daily. Altogether, 219 patients completed the trial. Rasagiline showed significantly greater efficacy compared with placebo. During the treatment period, the primary efficacy variable--mean adjusted total daily off time--decreased from baseline by 1.7 h in patients treated with 1.0 mg/d rasagiline compared to placebo (p rasagiline treatment. Rasagiline was well tolerated. This study demonstrated that rasagiline mesylate is effective and well tolerated as an adjunct to levodopa treatment in Chinese PD patients with fluctuations.

  5. 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.

    Science.gov (United States)

    Roberts, Jason A; De Waele, Jan J; Dimopoulos, George; Koulenti, Despoina; Martin, Claude; Montravers, Philippe; Rello, Jordi; Rhodes, Andrew; Starr, Therese; Wallis, Steven C; Lipman, Jeffrey

    2012-07-06

    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. 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. The DALI study should inform clinicians of the potential clinical advantages of achieving certain antibiotic pharmacokinetic exposures in infected critically ill patients.

  6. 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

    Directory of Open Access Journals (Sweden)

    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.

  7. The Effects of the Training in the Preparation Period on the Repetitive Strength Transformation with Cadet Level Football Players

    Directory of Open Access Journals (Sweden)

    Jovan Gardašević

    2016-06-01

    Full Text Available The main aim of the research was to identify a level of quantitative changes of the repetitive strength with fifteen years old football players under the influence of the programmed football training of a six weeks preparation period. The training programme covered forty-four training units. The research was made on a sample of 120 cadet level football players. To estimate the repetitive strength three tests have been used: Lying-sed for 30 seconds, Push-ups and Lifting upper body while lying on stomach. In the area of comparative statistics, we used discriminant parametric procedure t-test for big paired samples. It can be concluded that there are statistically significant differences in all three variables to estimate the repetitive strength. This confirmed the hypothesis that the expected significant positive quantitative changes of basic-motor abilities influenced by the proposed model of training in preparation period with fifteen years old football players. The authors were guided by the fact that this kind of training program in preparation period is very effective in terms of raising the repetitive strength level with fifteen years old. The obtained results can be directed towards innovation plans and programs in the preparation period, and the adaptation of the same needs of the respective population.

  8. Planeación estratégica para la Escuela Naval de Cadetes "Almirante Padilla" 2011-2019

    Directory of Open Access Journals (Sweden)

    Mónica Liliana Espíndola Bolaños

    2017-02-01

    Full Text Available 2019ResumenEl objetivo del presente trabajo fue realizar un ejer-cicio de Planeación Estratégica para la Escuela Naval de Cadetes “Almirante Padilla” para orientar los es-fuerzos en la Potencialización del Talento Humano, teniendo en cuenta los dos contextos: el de Institu-ción Militar ante el Ministerio de Defensa, y desde su connotación de Universidad a el Ministerio de Educación Nacional. Los objetivos trazados fueron evaluar diferentes metodologías de planeación es-tratégica y que se ajusten a las necesidades de la Es-cuela Naval, luego se realizó un diagnóstico externo e interno para la toma de decisiones, posteriormente se efectuó un análisis de escenarios de futuro y se finalizó con el Plan Estratégico 2011-2019.

  9. 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

  10. SMART: self-management of anticoagulation, a randomised trial [ISRCTN19313375].

    Science.gov (United States)

    McCahon, Deborah; Fitzmaurice, David A; Murray, Ellen T; Fuller, Christopher J; Hobbs, Richard F D; Allan, Teresa F; Raftery, James P

    2003-09-18

    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. 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. 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.

  11. 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.

  12. 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

  13. 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

    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...... about head-to-head differences in efficacy and tolerability of antipsychotics are scarce in children and adolescents. The TEA trial aims at expanding the evidence base for the use of antipsychotics in early onset psychosis in order to inform more rational treatment decisions in this vulnerable...

  14. Asymptomatic population reference values for three knee patient-reported outcomes measures: evaluation of an electronic data collection system and implications for future international, multi-centre cohort studies.

    Science.gov (United States)

    McLean, James M; Brumby-Rendell, Oscar; Lisle, Ryan; Brazier, Jacob; Dunn, Kieran; Gill, Tiffany; Hill, Catherine L; Mandziak, Daniel; Leith, Jordan

    2018-05-01

    The aim was to assess whether the Knee Society Score, Oxford Knee Score (OKS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) were comparable in asymptomatic, healthy, individuals of different age, gender and ethnicity, across two remote continents. The purpose of this study was to establish normal population values for these scores using an electronic data collection system. There is no difference in clinical knee scores in an asymptomatic population when comparing age, gender and ethnicity, across two remote continents. 312 Australian and 314 Canadian citizens, aged 18-94 years, with no active knee pain, injury or pathology in the ipsilateral knee corresponding to their dominant arm, were evaluated. A knee examination was performed and participants completed an electronically administered questionnaire covering the subjective components of the knee scores. The cohorts were age- and gender-matched. Chi-square tests, Fisher's exact test and Poisson regression models were used where appropriate, to investigate the association between knee scores, age, gender, ethnicity and nationality. There was a significant inverse relationship between age and all assessment tools. OKS recorded a significant difference between gender with females scoring on average 1% lower score. There was no significant difference between international cohorts when comparing all assessment tools. An electronic, multi-centre data collection system can be effectively utilized to assess remote international cohorts. Differences in gender, age, ethnicity and nationality should be taken into consideration when using knee scores to compare to pathological patient scores. This study has established an electronic, normal control group for future studies using the Knee society, Oxford, and KOOS knee scores. Diagnostic Level II.

  15. Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (II) Physiological and Symptomatic Responses of Early-Postmenopausal Women to Standardized doses of Maca in Double Blind, Randomized, Placebo-Controlled, Multi-Centre Clinical Study.

    Science.gov (United States)

    Meissner, H O; Mscisz, A; Reich-Bilinska, H; Kapczynski, W; Mrozikiewicz, P; Bobkiewicz-Kozlowska, T; Kedzia, B; Lowicka, A; Barchia, I

    2006-12-01

    This was a double-blind, randomized, placebo-corrected, outpatient, multi-centre (five sites) clinical study, in which a total of 168 Caucasian early-postmenopausal women volunteers (age>49 years) participated after fulfilling the criteria: follicle stimulating hormone (FSH) >30 IU/ml and estrogen (E2) Maca (Maca-GO) treatment, according to different monthly treatment sequences scheduled for each site. Two 500 mg vegetable hard gel capsules with Maca-GO or Placebo powder were self-administered twice daily with meals (total 2 g/day) during three (Trial I; n=102) or four (Trial II; n=66) months study periods. At the baseline and follow- up monthly intervals, blood levels of FSH, E2, progesterone (PRG) and lutinizing hormone (LH), as well as serum cholesterol (CHOL), triglycerides (TRG), high- and low density lipoproteins (HDL and LDL) were measured. Menopausal symptoms were assessed according to Greene's Score (GMS) and Kupperman's Index (KMI). Data were analyzed using multivariate technique on blocs of monthly results in one model and Maca versus Placebo contrast in another model. A total of 124 women concluded the study. Maca-GO significantly stimulated production of E2 (PMaca-GO significantly reduced both frequency and severity of individual menopausal symptoms (hot flushes and night sweating in particular) resulting in significant (P<0.001) alleviation of KMI (from 22 to 10), thus, offering an attractive non-hormonal addition to the choices available to early-postmenopausal women in the form of a natural plant alternative to Hormone Replacement Therapy (HRT) - hence, reducing dependence on hormone therapy programs.

  16. Comparison of haemodialysis patients and non-haemodialysis patients with respect to clinical characteristics and 3-year clinical outcomes after sirolimus-eluting stent implantation: insights from the Japan multi-centre post-marketing surveillance registry.

    Science.gov (United States)

    Otsuka, Yoritaka; Ishiwata, Sugao; Inada, Tsukasa; Kanno, Hiroyuki; Kyo, Eisho; Hayashi, Yasuhiko; Fujita, Hiroshi; Michishita, Ichiro

    2011-04-01

    Long-term outcomes after sirolimus-eluting stent (SES) implantation in haemodialysis (HD) patients have remained controversial. We investigated the impact of HD on outcomes after SES implantation. We analysed the data on 2050 patients who underwent SES implantation in a multi-centre prospective registry in Japan. Three-year clinical outcomes were compared between the HD group (n = 106) and the non-haemodialysis (NH) group (n = 1944). At the 3-year clinical follow-up, the rates of unadjusted cardiac mortality (HD: 16.3 vs. NH: 2.3%) and target-lesion revascularization (TLR) (HD: 19.4 vs. NH: 6.6%) were significantly higher in the HD group than the NH group (P statistical significance. Using Cox's proportional-hazard models with propensity score adjustment for baseline differences, the HD group had higher risks of TLR [HD: 16.3 vs. NH: 6.1%; hazard ratio, 2.83; 95% confidence interval (CI): 1.62-4.93, P = 0.0003] and cardiac death (HD: 12.3 vs. NH: 2.3%; hazard ratio, 5.51; 95% CI: 2.58-11.78, P < 0.0001). The consistent results of analyses, whether unadjusted or adjusted for other baseline clinical and procedural differences, identify HD as an independent risk factor for cardiac death and TLR. Percutaneous coronary intervention with SES in HD patients has a higher incidence of repeat revascularization and mortality compared with those in NH patients. Haemodialysis appears to be strongly associated with mortality and repeat revascularization even after SES implantation.

  17. Development of a disease-specific quality of life questionnaire for adult patients with hereditary angioedema due to C1 inhibitor deficiency (HAE-QoL): Spanish multi-centre research project.

    Science.gov (United States)

    Prior, Nieves; Remor, Eduardo; Gómez-Traseira, Carmen; López-Serrano, Concepción; Cabañas, Rosario; Contreras, Javier; Campos, Ángel; Cardona, Victoria; Cimbollek, Stefan; González-Quevedo, Teresa; Guilarte, Mar; de Rojas, Dolores Hernández Fernández; Marcos, Carmen; Rubio, María; Tejedor-Alonso, Miguel Ángel; Caballero, Teresa

    2012-07-20

    There is a need for a disease-specific instrument for assessing health-related quality of life in adults with hereditary angioedema due to C1 inhibitor deficiency, a rare, disabling and life-threatening disease. In this paper we report the protocol for the development and validation of a specific questionnaire, with details on the results of the process of item generation, domain selection, and the expert and patient rating phase. Semi-structured interviews were completed by 45 patients with hereditary angioedema and 8 experts from 8 regions in Spain. A qualitative content analysis of the responses was carried out. Issues raised by respondents were grouped into categories. Content analysis identified 240 different responses, which were grouped into 10 conceptual domains. Sixty- four items were generated. A total of 8 experts and 16 patients assessed the items for clarity, relevance to the disease, and correct dimension assignment. The preliminary version of the specific health-related quality of life questionnaire for hereditary angioedema (HAE-QoL v 1.1) contained 44 items grouped into 9 domains. To the best of our knowledge, this is the first multi-centre research project that aims to develop a specific health-related quality of life questionnaire for adult patients with hereditary angioedema due to C1 inhibitor deficiency. A preliminary version of the specific HAE-QoL questionnaire was obtained. The qualitative analysis of interviews together with the expert and patient rating phase helped to ensure content validity. A pilot study will be performed to assess the psychometric properties of the questionnaire and to decide on the final version.

  18. 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.

  19. TEMPS-A[p] temperament profile related to professional choice: A study in 1548 applicants to become a cadet officer in the Italian air force.

    Science.gov (United States)

    Maremmani, Icro; Dell'Osso, Liliana; Rovai, Luca; Pacini, Matteo; Arduino, Gualberto; Montagnari, Antonio; Abbenante, Domenico; Maremmani, Angelo G I; Giulio, Perugi; Akiskal, Kareen; Akiskal, Hagop

    2010-08-01

    Temperaments have been described with respect to their adaptive roles. Thus, depressive traits seem to increase sensitivity to suffering, cyclothymic traits appear relevant to creativity, and hyperthymic traits have been implicated in territoriality and leadership and more generally in active pursuits. The temperaments of 1548 candidates applying to become a cadet officer in the Italian air force, who had taken the 2005 entrance examination, were compared with deviant and non-deviant peers. At a psychological level, we also compared those who had applied to become a cadet officer with other applicants who had failed in a previous entrance examination and with applicants who had passed or failed to pass the specific psychological entrance examination. Applicants who took the entrance examination are more hyperthymic than their peers, regardless of any concurrent psychosocial deviance (i.e. drug addiction). The specificity of this correlation is confirmed by the fact that applicants who made a second attempt to pass the entrance examination after an initial failure were more hyperthymic than first-time applicants. Similarly, success in specific psychological admission tests is related to the same temperamental profiles, since those who prove to be psychologically fit are more hyperthymic. The inverse relationship emerges from an examination of other temperamental scales, which are better represented in controls (non-applicants), or other applicants making their first attempt at admission, or those who were excluded due to psychological flaws. In the present study, extremely high scores on the hyperthymic scale combined with extremely low ones in the cyclothymic scale seem to correspond to the specific temperament profile and to the highest likelihood of success in those applying to become a cadet officer in the Italian air force. Copyright 2010 Elsevier B.V. All rights reserved.

  20. Randomised clinical trial

    DEFF Research Database (Denmark)

    Reimer, C; Lødrup, A; Smith, G

    2016-01-01

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

  1. [Balance of iron and copper in cadets of military school during physical exercise and next-day rest at different times of the year].

    Science.gov (United States)

    Zaĭtseva, I P; Nasolodin, V V; Beliakov, R A; Arshinov, N P; Zaĭtsev, O N; Meshcheriakov, S I

    2013-03-01

    According to examination, with the help of emission spectrum analysis method, of 24 cadets-athletes of different specialization it was determined that during physical exercise in summer and in winter loss of ferrum and copper with excrements exceeded the intake if these microelements with food. The next day rise of impaction of microelements and decrease of excretion. But despite the positive balance of ferrum and copper, spend of these microelements during physical exercise wasn't compensated for the day of rest. That is why there is a possibility of microelement deficit.

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

    Directory of Open Access Journals (Sweden)

    Xu Guifa

    2010-05-01

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

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

    Science.gov (United States)

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

    2010-07-01

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

  4. Temperamental traits and results of psychoaptitude tests in applicants to become a cadet officer in the Italian Navy.

    Science.gov (United States)

    Maremmani, Icro; Maremmani, Angelo Giovanni Icro; Leonardi, Annalisa; Rovai, Luca; Bacciardi, Silvia; Rugani, Fabio; Dell'Osso, Liliana; Akiskal, Kareen; Akiskal, S Hagop

    2013-09-05

    Consistently with the involvement of affective temperaments in professional choices, our research team is aiming to outline the temperamental profile of subjects who are applying to enter a military career in the Italian Armed Forces. In this study we aim to verify the importance of temperamental traits not only in choosing the military career as a profession, but also in passing or failing the entrance examinations. We compared the affective temperaments (evaluated by TEMPS-A[P]) of those applying to become a cadet officer in the Italian Navy, divided into various subgroups depending on whether they passed or failed the entrance examination at various levels (high school final test, medical (physical and psychiatric), mathematical examination and aptitude test). We also tested for correlations between grades received and temperamental scores. Higher scores for those with a hyperthymic and lower scores for those with a depressive, cyclothymic or irritable temperament characterized applicants taking medical exams and aptitude tests. Higher scores on the high school final test correlated with lower hyperthymic, cyclothymic and irritable temperament scores. No correlations were found between temperamental traits and mathematical examinations. Multivariate analysis stressed the negative impact of a cyclothymic temperament and the poor discriminant power of temperaments regarding medical and mathematical examinations, and aptitude tests. Conversely, temperaments showed good discriminant power as far as psychiatric examinations are concerned. Hyperthymic temperamental traits appear to be important not only in choosing a profession, but also in passing entrance examinations. Even so, affective temperaments (strong hyperthymic and weak cyclothymic, depressive and irritable traits) are the only successfully predictors of the outcome of psychiatric examinations and, to a lesser extent, medical examinations and aptitude tests. Achieving high school graduation and passing

  5. Self-Concept and Achievement Motivation of Cadets in the Russian Interio Ministry Troops According to the Deviance Disposition: Comparative Analysis

    Directory of Open Access Journals (Sweden)

    L. I. Dorfman

    2013-01-01

    Full Text Available The demand for the moral psychological training in military higher schools is enforced by the changing situation both in our country and globally. The potential officers should posses such qualities as fortitude, stability, self-regulation, self-direction, and ability to restrain the undesirable emotions. The paper deals with the psychological investigation of motivational profile of junior cadets at the Military Higher School of the Russian Interior Ministry Troops. The author undertakes the comparative analysis of the cadets’ psychological resistance to adverse situations according to the deviance disposition level. The research methodology combines the psychometrical approach, meta-individual world concept and plural self theory. The research objectives include: studying the self-concept and poly-modal achievement motives of cadets; and comparative analysis of their personal traits with regard to their deviance disposition level – explicit or implicit. The research findings can be applied by psychologists and personnel officers in military higher schools of the Russian Interior Ministry for diagnosing the deviance disposition and its prevention. The materials can be implied in further investigation of personal motivational profiles of potential officers. 

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    Nuttall Jacqueline

    2011-02-01

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

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

    Science.gov (United States)

    2011-01-01

    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 in UK. This study

  9. Intravenous iron vs blood for acute post-partum anaemia (IIBAPPA): a prospective randomised trial.

    Science.gov (United States)

    Chua, Seng; Gupta, Sarika; Curnow, Jennifer; Gidaszewski, Beata; Khajehei, Marjan; Diplock, Hayley

    2017-12-19

    Acute post-partum anaemia can be associated with significant morbidity including a predisposition for postnatal depression. Lack of clear practice guidelines means a number of women are treated with multiple blood transfusions. Intravenous iron has the potential to limit the need for multiple blood transfusions but its role in the post-partum setting is unclear. IIBAPPA is a multi-centre randomised non-inferiority trial. Women with a primary post-partum haemorrhage (PPH) >1000 mL and resultant haemoglobin (Hb) 5.5-8.0 g/dL after resuscitation with ongoing symptomatic anaemia who are otherwise stable (no active bleeding) are eligible to participate. Patients with sepsis or conditions necessitating rapid Hb restoration are excluded. Eligible participants are randomised to receive a blood transfusion or a single dose of intravenous iron polymaltose calculated using the Ganzoni formula. Primary outcome measures include Hb, Ferritin and C-Reactive Protein levels on Day 7. Secondary outcomes evaluate (i) Hb, Ferritin and CRP levels on Day 14, 28, (ii) anaemia symptoms on Day 0, 7, 14 and 28 using structured health related quality of life questionnaires, (iii) treatment safety by assessing adverse reactions and infection endpoints and (iv) the quantitative impact of anaemia on breast feeding quality using a hospital designed questionnaire. If equivalence in Hb and ferritin levels, symptom scores and safety endpoints is demonstrated, intravenous iron may become the preferred treatment for women with acute post-partum anaemia to minimise transfusion reactions and costs. Australian and New Zealand Clinical Trials Registry: ACTRN12615001370594 on 16th December, 2015 (prospective approval).

  10. Efficacy and safety of lesogaberan in gastro-oesophageal reflux disease: a randomised controlled trial.

    Science.gov (United States)

    Shaheen, Nicholas J; Denison, Hans; Björck, Karin; Karlsson, Maria; Silberg, Debra G

    2013-09-01

    Lesogaberan (AZD3355) is a novel γ-aminobutyric acid B-type receptor agonist designed to treat gastro-oesophageal reflux disease (GERD) by inhibiting transient lower oesophageal sphincter relaxations. A randomised, double-blind, placebo-controlled, multi-centre phase IIb study was performed to assess the efficacy and safety of lesogaberan as an add-on to proton pump inhibitor (PPI) therapy in patients with GERD who are partially responsive to PPI therapy (ClinicalTrials.gov reference: NCT01005251). In total, 661 patients were randomised to receive 4 weeks of placebo or 60, 120, 180 or 240 mg of lesogaberan twice daily, in addition to ongoing PPI therapy. Symptoms were measured using the Reflux Symptom Questionnaire electronic Diary. Response to treatment was defined as having an average of ≥ 3 additional days per week of not more than mild GERD symptoms during treatment compared with baseline. In the primary analysis, 20.9%, 25.6%, 23.5% and 26.2% of patients responded to the 60, 120, 180 and 240 mg twice daily lesogaberan doses, respectively, and 17.9% responded to placebo. The response to the 240 mg twice daily dose was statistically significantly greater than the response to placebo using a one-sided test at the predefined significance level of p < 0.1. However, the absolute increases in the proportions of patients who responded to lesogaberan compared with placebo were low. Lesogaberan was generally well tolerated, although six patients receiving lesogaberan developed reversible elevated alanine transaminase levels. In patients with GERD symptoms partially responsive to PPI therapy, lesogaberan was only marginally superior to placebo in achieving an improvement in symptoms.

  11. One-stage or two-stage revision surgery for prosthetic hip joint infection--the INFORM trial: a study protocol for a randomised controlled trial.

    Science.gov (United States)

    Strange, Simon; Whitehouse, Michael R; Beswick, Andrew D; Board, Tim; Burston, Amanda; Burston, Ben; Carroll, Fran E; Dieppe, Paul; Garfield, Kirsty; Gooberman-Hill, Rachael; Jones, Stephen; Kunutsor, Setor; Lane, Athene; Lenguerrand, Erik; MacGowan, Alasdair; Moore, Andrew; Noble, Sian; Simon, Joanne; Stockley, Ian; Taylor, Adrian H; Toms, Andrew; Webb, Jason; Whittaker, John-Paul; Wilson, Matthew; Wylde, Vikki; Blom, Ashley W

    2016-02-17

    Periprosthetic joint infection (PJI) affects approximately 1% of patients following total hip replacement (THR) and often results in severe physical and emotional suffering. Current surgical treatment options are debridement, antibiotics and implant retention; revision THR; excision of the joint and amputation. Revision surgery can be done as either a one-stage or two-stage operation. Both types of surgery are well-established practice in the NHS and result in similar rates of re-infection, but little is known about the impact of these treatments from the patient's perspective. The main aim of this randomised controlled trial is to determine whether there is a difference in patient-reported outcome measures 18 months after randomisation for one-stage or two-stage revision surgery. INFORM (INFection ORthopaedic Management) is an open, two-arm, multi-centre, randomised, superiority trial. We aim to randomise 148 patients with eligible PJI of the hip from approximately seven secondary care NHS orthopaedic units from across England and Wales. Patients will be randomised via a web-based system to receive either a one-stage revision or a two-stage revision THR. Blinding is not possible due to the nature of the intervention. All patients will be followed up for 18 months. The primary outcome is the WOMAC Index, which assesses hip pain, function and stiffness, collected by questionnaire at 18 months. Secondary outcomes include the following: cost-effectiveness, complications, re-infection rates, objective hip function assessment and quality of life. A nested qualitative study will explore patients' and surgeons' experiences, including their views about trial participation and randomisation. INFORM is the first ever randomised trial to compare two widely accepted surgical interventions for the treatment of PJI: one-stage and two-stage revision THR. The results of the trial will benefit patients in the future as the main focus is on patient-reported outcomes: pain, function

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

    Directory of Open Access Journals (Sweden)

    O'Donovan Michael

    2008-05-01

    Full Text Available Abstract Background The most effective pharmacological treatments for depression inhibit the transporters that reuptake serotonin (Selective Serotonin Reuptake Inhibitors – SSRIs and noradrenaline (Noradrenaline Reuptake Inhibitors – NaRIs into the presynaptic terminal. There is evidence to suggest that noradrenaline and serotonin enhancing drugs work through separate mechanisms to produce their clinical antidepressant action. Although most of the current evidence suggests there is little difference in overall efficacy between SSRIs and NaRIs, there are patients who respond to one class of compounds and not another. This suggests that treatment response could be predicted by genetic and/or clinical characteristics. Firstly, this study aims to investigate the influence of a polymorphism (SLC6A4 in the 5HT transporter in altering response to SSRI medication. Secondly, the study will investigate whether those with more severe depression have a better response to NaRIs than SSRIs. Methods/design The GenPod trial is a multi-centre randomised controlled trial. GPs referred patients aged between 18–74 years presenting with a new episode of depression, who did not have any medical contraindications to antidepressant medication and who had no history of psychosis or alcohol/substance abuse. Patients were interviewed to ascertain their suitability for the study. Eligible participants (with a primary diagnosis of depression according to ICD10 criteria and a Beck Depression Inventory (BDI score > 14 were randomised to receive one of two antidepressant treatments, either the SSRI Citalopram or the NaRI Reboxetine, stratified according to severity. The final number randomised to the trial was 601. Follow-up assessments took place at 2, 6 and 12 weeks following randomisation. Primary outcome was measured at 6 weeks by the BDI. Outcomes will be analysed on an intention-to-treat basis and will use multiple regression models to compare treatments

  13. Screening and brief interventions for hazardous alcohol use in accident and emergency departments: a randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Myles Judy

    2009-07-01

    service utilisation. Discussion This paper presents a protocol for a large multi-centre pragmatic factorial cluster randomised trial to evaluate the effectiveness and cost-effectiveness of screening and brief interventions for hazardous alcohol users attending emergency departments. Trial Registration ISRCTN 93681536

  14. Randomised clinical trial

    DEFF Research Database (Denmark)

    Coyle, C; Crawford, G; Wilkinson, J

    2017-01-01

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

  15. Punto Vive Digital Plus como apoyo en el uso de las TIC en la Escuela Naval de Cadetes “Almirante Padilla”

    Directory of Open Access Journals (Sweden)

    Freddy Herrera De Aguas

    2017-02-01

    Full Text Available Esta investigación trata sobre el uso que han tenido las diferentes tecnologías instaladas con la creación del Punto Vive Digital Plus ubicado en la Escuela Naval de Cadetes, el cual ofrece un espacio para la capacitación y generación de ideas innovadoras en la comunidad académica. La metodología consiste en realizar una encuesta en línea previa, posteriormente enseñar a los semilleros conformados por un perso-nal de docentes y estudiantes sobre el uso de algu-nas herramientas tecnológicas, luego medir el avance que han tenido por medio del desarrollo de activi-dades creativas aprovechando el trabajo en equipo.

  16. Anàlisi comparatiu sobre l’efectivitat de la prevenció de lesions entre infantils i cadets en el futbol base masculí

    OpenAIRE

    Basquens Espada, Eric

    2016-01-01

    Els objectius d'aquest treball és conèixer quin tipus de lesions es produeixen en un equip infantil i cadet de futbol base masculí, aplicar un treball preventiu per poder conèixer si existeix una reducció de les lesions mitjançant aquest tipus de treball. I de manera més específica, conèixer la gravetat de les lesions d'aquest edat i conèixer quin grup d'edat en el futbol no es lesiona i perquè. Per poder realitzar aquest treball he utilitzat un grup control, on no realitzaven treball prev...

  17. A randomised controlled trial evaluating the effect of an individual auditory cueing device on freezing and gait speed in people with Parkinson's disease

    Directory of Open Access Journals (Sweden)

    Lynch Deirdre

    2008-12-01

    Full Text Available Abstract Background Parkinson's disease is a progressive neurological disorder resulting from a degeneration of dopamine producing cells in the substantia nigra. Clinical symptoms typically affect gait pattern and motor performance. Evidence suggests that the use of individual auditory cueing devices may be used effectively for the management of gait and freezing in people with Parkinson's disease. The primary aim of the randomised controlled trial is to evaluate the effect of an individual auditory cueing device on freezing and gait speed in people with Parkinson's disease. Methods A prospective multi-centre randomised cross over design trial will be conducted. Forty-seven subjects will be randomised into either Group A or Group B, each with a control and intervention phase. Baseline measurements will be recorded using the Freezing of Gait Questionnaire as the primary outcome measure and 3 secondary outcome measures, the 10 m Walk Test, Timed "Up & Go" Test and the Modified Falls Efficacy Scale. Assessments are taken 3-times over a 3-week period. A follow-up assessment will be completed after three months. A secondary aim of the study is to evaluate the impact of such a device on the quality of life of people with Parkinson's disease using a qualitative methodology. Conclusion The Apple iPod-Shuffle™ and similar devices provide a cost effective and an innovative platform for integration of individual auditory cueing devices into clinical, social and home environments and are shown to have immediate effect on gait, with improvements in walking speed, stride length and freezing. It is evident that individual auditory cueing devices are of benefit to people with Parkinson's disease and the aim of this randomised controlled trial is to maximise the benefits by allowing the individual to use devices in both a clinical and social setting, with minimal disruption to their daily routine. Trial registration The protocol for this study is registered

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

    Directory of Open Access Journals (Sweden)

    Morton Veronica

    2008-06-01

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

  19. TEMPS-A[P] temperament profile related to professional choice. Differences between applicants to become a cadet officer in the Italian Air Force or Navy.

    Science.gov (United States)

    Rovai, Luca; Maremmani, Angelo Giovanni Icro; Leonardi, Annalisa; Bacciardi, Silvia; Rugani, Fabio; Dell'Osso, Liliana; Akiskal, Hagop S; Maremmani, Icro

    2013-02-15

    Temperament appears to be a factor involved in professional attitudes. The most impressive findings are those on the importance of cyclothymia in art and of hyperthymia in leadership. In this study we raise the issue of whether the relationship between hyperthymic temperament and the choice of a military career, previously reported among Italian Air Force applicants, can be extended to another military service such as the Italian Navy. We compared temperaments between those who had applied to become a cadet officer in the Italian Air Force or in the Italian Navy, with special reference to gender differences and the ability of the two types of applicants to pass the psychiatric examination for admission that we had recently assessed in the Italian Air Force. Hyperthymic traits were well represented in both these armed services. Navy applicants differed from air-force applicants in obtaining higher depressive, cyclothymic and irritable scores. Navy applicants who passed the psychiatric entrance examination (PEE) showed the same incidence of hyperthymic temperament as their Air Force counterparts, but higher depressive, cyclothymic and irritable scores. Considering gender, among Air Force applicants depressive traits were better represented in males; conversely, among Navy applicants they were better represented in females. If we consider gender together with PEE results, the highest hyperthymic scores were more frequently found among males who passed and females who failed to pass the PEE. On the other hand, a greater number of cyclothymic traits were found in females who passed and males who failed to pass the PEE. It was confirmed that hyperthymic temperament represents the temperamental profile of those who aim to become a cadet officer in the Italian armed forces. This study further supports the idea that hyperthymic traits bring distinct advantages in a professional field, such as a military career, which is closely related to leadership. Copyright © 2012

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

    Directory of Open Access Journals (Sweden)

    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

  1. Design and baseline characteristics of the Food4Me study: a web-based randomised controlled trial of personalised nutrition in seven European countries.

    Science.gov (United States)

    Celis-Morales, Carlos; Livingstone, Katherine M; Marsaux, Cyril F M; Forster, Hannah; O'Donovan, Clare B; Woolhead, Clara; Macready, Anna L; Fallaize, Rosalind; Navas-Carretero, Santiago; San-Cristobal, Rodrigo; Kolossa, Silvia; Hartwig, Kai; Tsirigoti, Lydia; Lambrinou, Christina P; Moschonis, George; Godlewska, Magdalena; Surwiłło, Agnieszka; Grimaldi, Keith; Bouwman, Jildau; Daly, E J; Akujobi, Victor; O'Riordan, Rick; Hoonhout, Jettie; Claassen, Arjan; Hoeller, Ulrich; Gundersen, Thomas E; Kaland, Siv E; Matthews, John N S; Manios, Yannis; Traczyk, Iwona; Drevon, Christian A; Gibney, Eileen R; Brennan, Lorraine; Walsh, Marianne C; Lovegrove, Julie A; Alfredo Martinez, J; Saris, Wim H M; Daniel, Hannelore; Gibney, Mike; Mathers, John C

    2015-01-01

    Improving lifestyle behaviours has considerable potential for reducing the global burden of non-communicable diseases, promoting better health across the life-course and increasing well-being. However, realising this potential will require the development, testing and implementation of much more effective behaviour change interventions than are used conventionally. Therefore, the aim of this study was to conduct a multi-centre, web-based, proof-of-principle study of personalised nutrition (PN) to determine whether providing more personalised dietary advice leads to greater improvements in eating patterns and health outcomes compared to conventional population-based advice. A total of 5,562 volunteers were screened across seven European countries; the first 1,607 participants who fulfilled the inclusion criteria were recruited into the trial. Participants were randomly assigned to one of the following intervention groups for a 6-month period: Level 0-control group-receiving conventional, non-PN advice; Level 1-receiving PN advice based on dietary intake data alone; Level 2-receiving PN advice based on dietary intake and phenotypic data; and Level 3-receiving PN advice based on dietary intake, phenotypic and genotypic data. A total of 1,607 participants had a mean age of 39.8 years (ranging from 18 to 79 years). Of these participants, 60.9 % were women and 96.7 % were from white-European background. The mean BMI for all randomised participants was 25.5 kg m(-2), and 44.8 % of the participants had a BMI ≥ 25.0 kg m(-2). Food4Me is the first large multi-centre RCT of web-based PN. The main outcomes from the Food4Me study will be submitted for publication during 2015.

  2. Group treatments for sensitive health care problems: a randomised controlled trial of group versus individual physiotherapy sessions for female urinary incontinence.

    Science.gov (United States)

    Lamb, S E; Pepper, J; Lall, R; Jørstad-Stein, E C; Clark, M D; Hill, L; Fereday-Smith, J

    2009-09-14

    The aim was to compare effectiveness of group versus individual sessions of physiotherapy in terms of symptoms, quality of life, and costs, and to investigate the effect of patient preference on uptake and outcome of treatment. A pragmatic, multi-centre randomised controlled trial in five British National Health Service physiotherapy departments. 174 women with stress and/or urge incontinence were randomised to receive treatment from a physiotherapist delivered in a group or individual setting over three weekly sessions. Outcome were measured as Symptom Severity Index; Incontinence-related Quality of Life questionnaire; National Health Service costs, and out of pocket expenses. The majority of women expressed no preference (55%) or preference for individual treatment (36%). Treatment attendance was good, with similar attendance with both service delivery models. Overall, there were no statistically significant differences in symptom severity or quality of life outcomes between the models. Over 85% of women reported a subjective benefit of treatment, with a slightly higher rating in the individual compared with the group setting. When all health care costs were considered, average cost per patient was lower for group sessions (Mean cost difference 52.91 pounds 95%, confidence interval ( 25.82 pounds- 80.00 pounds)). Indications are that whilst some women may have an initial preference for individual treatment, there are no substantial differences in the symptom, quality of life outcomes or non-attendance. Because of the significant difference in mean cost, group treatment is recommended. ISRCTN 16772662.

  3. 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

    Directory of Open Access Journals (Sweden)

    David Thurtle

    2014-12-01

    Full Text Available 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 financial 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 sufficient evidence to justify a full clinical trial that attempts to prevent this aggressive cancer in a high-risk population.

  4. 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

  5. Estudio multicéntrico de prevalencia de infección tuberculosa latente en los internados en prisiones españolas Multi-centre study of the prevalance of latent tuberculosis infection amongst inmates in spanish prisons

    Directory of Open Access Journals (Sweden)

    J. García-Guerrero

    2010-02-01

    Full Text Available Objetivo: Estudiar la prevalencia de infección tuberculosa latente (ITL entre los presos internados en las prisiones españolas. Material y Método: Estudio multicéntrico, observacional y transversal; muestreo por conglomerado bietápico. Se recogieron variables sociodemográficas, penitenciarias y clínico-serológicas. Se realizó análisis univariante, bivariante y multivariante mediante regresión logística con las variables que mostraron significación estadística. Se calculó la odds ratio con intervalo de confianza del 95%. Resultados: 378 pacientes. Se dispuso de intradermorreacción de Mantoux (IDRM valorable en el 90,2%. 91,2% hombres, 37,8% extranjeros con edad media de 35,9±10,3 años. Mediana de estancia en prisión: 2 años y el 28,7% había estado > 5 años en prisión. El 49,6% ingresó en prisión en 2006 o antes. El 24,5% tenía antecedentes de uso de drogas intravenosas (UDI. El 50,4% presentaba ITL que se asoció a: edad > 40 años (63,2 vs 43,8%; IC: 1,39-3,49; OR: 2,20; p=0,001; haber estado > 5 años en prisión (71,2 vs 41,3%; IC: 2,13-5,75; OR: 3,50; p 40 años (OR:1,76; IC: 1,08-2,87; p=0,024; y b estancia > 5 años en prisión (OR: 2,50; IC: 1,41-4,43; p=0,002. Conclusiones: La prevalencia de ITL en prisión es muy alta, sobre todo en los mayores de 40 años y los que están más de cinco años en prisión. Para evitar el riesgo de progresión a tuberculosis, se recomienda tratar a los infectados que lo precisen y mantener los programas de control de esta patología.Aims: To study the prevalence of latent tuberculosis infection (LTBI amongst inmates in Spanish prisons. Materials and Methods: Multi-centre, cross-sectional study; two stage sampling. Socio-demographic, prison and clinical variables were gathered. A univariate, bivariate and multivariate analysis was carried out using logistic regression with the variables that showed statistical significance. The odds ratio was calculated with a confidence interval

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

    Science.gov (United States)

    Baxter, Helen; Winder, Rachel; Chalder, Melanie; Wright, Christine; Sherlock, Sofie; Haase, Anne; Wiles, Nicola J; Montgomery, Alan A; Taylor, Adrian H; Fox, Ken R; Lawlor, Debbie A; Peters, Tim J; Sharp, Deborah J; Campbell, John; Lewis, Glyn

    2010-11-12

    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. 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. The results of the trial will provide information about the effectiveness of

  7. 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

  8. Conservative treatment of a mandibular condyle fracture: Comparing intermaxillary fixation with screws or arch bar. A randomised clinical trial.

    Science.gov (United States)

    van den Bergh, B; Blankestijn, J; van der Ploeg, T; Tuinzing, D B; Forouzanfar, T

    2015-06-01

    A mandibular condyle fracture can be treated conservatively by intermaxillary fixation (IMF) or by open reposition and internal fixation (ORIF). Many IMF-modalities can be chosen, including IMF-screws (IMFS). This prospective multi-centre randomised clinical trial compared the use of IMFS with the use of arch bars in the treatment of mandibular condyle fractures. The study population consisted of 50 patients (mean age: 31.8 years). Twenty-four (48%) patients were allocated in the IMFS group. Twenty-six (52%) patients were assigned to the arch bars group. In total 188 IMF-screws were used (5-12 screws per patient, mean 7.83 screws per patient). All pain scores were lower in the IMFS group. Three patients developed a malocclusion (IFMS-group: one patient, arch bars-group: two patients). Mean surgical time was significantly shorter in the IMFS group (59 vs. 126 min; pfractured on insertion (0.53%), one (0.53%) screw was inserted into a root. Six (3.2%) screws loosened spontaneously in four patients. Mucosal disturbances were seen in 22 patients, equally divided over both groups. Considering the advantages and the disadvantages of IMFS, and observing the results of this study, the authors conclude that IMFS provide a superior method for IMF. IMFS are safer for the patients and surgeons. Copyright © 2015 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  9. Hyperglycaemia in early pregnancy: the Treatment of Booking Gestational diabetes Mellitus (TOBOGM) study. A randomised controlled trial.

    Science.gov (United States)

    Simmons, David; Hague, William M; Teede, Helena J; Cheung, N Wah; Hibbert, Emily J; Nolan, Christopher J; Peek, Michael J; Girosi, Federico; Cowell, Christopher T; Wong, Vincent W-M; Flack, Jeff R; McLean, Mark; Dalal, Raiyomand; Robertson, Annette; Rajagopal, Rohit

    2018-05-28

    Gestational diabetes mellitus (GDM) causes adverse pregnancy outcomes that can be averted by treatment from 24-28 weeks' gestation. Assessing and treating women for overt diabetes in pregnancy (ODIP) at the first antenatal clinic booking is now recommended in international guidelines. As a consequence, women with milder hyperglycaemia are being diagnosed and treated for early GDM, but randomised controlled trial (RCTs) assessing the benefits and harms of such treatment have not been undertaken. The Treatment Of Booking Gestational diabetes Mellitus (TOBOGM) study is a multi-centre RCT examining whether diagnosing and treating GDM diagnosed at booking improves pregnancy outcomes. Methods and analysis: 4000 adult pregnant women (lean body mass. The primary maternal outcome is pre-eclampsia. Ethics approval: South Western Sydney Local Health District Research and Ethics Office (reference, 15/LPOOL/551). Dissemination of results: Peer-reviewed publications, scientific meetings, collaboration with research groups undertaking comparable studies, discussions with guideline groups and policy makers. Australian New Zealand Clinical Trials Registry, ACTRN12616000924459.

  10. Randomised trial of biofeedback training for encopresis

    NARCIS (Netherlands)

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

    1996-01-01

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

  11. Peri-operative morbidity and early results of a randomised trial comparing TVT and TVT-O.

    Science.gov (United States)

    Meschia, Michele; Bertozzi, Rosanna; Pifarotti, Paola; Baccichet, Roberto; Bernasconi, Francesco; Guercio, Elso; Magatti, Fabio; Minini, Gianfranco

    2007-11-01

    The aim of this study was to compare the morbidity and short-term efficacy of retro-pubic (TVT) and inside-out trans-obturator (TVT-O) sub-urethral sling in the treatment of stress urinary incontinence. This was a prospective multi-centre randomised trial; 231 women with primary stress urinary incontinence were randomised to TVT (114) or TVT-O (117). The International Consultation on Incontinence-Short Form (ICIQ-SF), Women Irritative Prostate Symptoms Score (W-IPSS) and Patient Global Impression of Severity (PGI-S) questionnaires were used to evaluate the impact of incontinence and voiding dysfunction on QoL and to measure the patient's perception of incontinence severity. The primary and secondary outcome measures were rates of success and complications. The SPSS software was used for data analysis. The TVT-O procedure was associated with significantly shorter operation time and with a more extensive use of general anaesthesia when compared with TVT. There were 5 (4%) bladder perforations in the TVT group compared with none in the TVT-O group. Rates of early post-operative urinary retention and voiding difficulty were similar for both groups and no difference was found in the average hospital stay. Six patients (5%) in the TVT-O group complained of thigh pain in the post-operative course. The median follow-up time was 6 months. Two hundred eighteen patients were available for the analysis of outcomes. Subjective and objective cure rates were 92% and 92% in the TVT group and 87% and 89% in the TVT-O group. The ICIQ-SF questionnaire symptoms score showed a highly statistical decrease in both groups, the W-IPSS on the contrary was unchanged. Our data show that both procedures were equally effective in the short-term for the treatment of stress urinary incontinence with a highly significant improvement in incontinence-related QoL.

  12. A randomised trial of preoperative radiotherapy for stage T3 adenocarcinoma of rectum (TROG 01.04): a progress report

    International Nuclear Information System (INIS)

    Ngan, S.; Fisher, R.; McKay, M.J.; McClure, B.; Burmeister, B.H.; Schache, D.; Joseph, D.; Solomon, M.; Ackland, S.P.; Goldstein, D.; McLachlan, S.; Dhillon, H.; Thompson, P.

    2003-01-01

    To provide a progress report of the conduct of the randomised trial TROG 01.04. This is a randomised Australian and New Zealand multi-centre trial of preoperative radiotherapy for rectal cancer currently being conducted under the auspices of Trans-Tasman Radiation Oncology Group, Australasian Gastrointestinal Trials Group, Colorectal Surgical Society of Australasia, and Royal Australasian College of Surgeons. The trial comprises two studies, each with its own main objective. These objectives are, in patients with T3 clinically resectable carcinoma of the rectum, to demonstrate that (Study 1) the local recurrence rate in patients treated with a long course (LC) of pre-operative radiotherapy with continuous infusion 5-FU is lower than that in patients treated with a short course (SC) of pre-operative radiotherapy with early surgery; and (Study 2) the local recurrence rate in patients given pre-operative radiotherapy and chemotherapy is lower than that in patients treated with initial surgery. Over 150 patients have been accrued from 21 centres in the first 21 months. All patients were enrolled on Study 1, SC versus LC pre-operative radiotherapy. Study 2 has enrolled no patients in 15 months and has been discontinued. There was no obvious difference in rates of serious adverse events of SC and LC. An Independent Data Monitoring Committee is monitoring these and other aspects of the trial. The trial of SC versus LC is progressing well: such a trial is clearly feasible in Australia and New Zealand. It is however not feasible to compare initial surgery with preoperative radiotherapy

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

    Science.gov (United States)

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

    2005-04-01

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

  14. Neonatal ECMO Study of Temperature (NEST - a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Juszczak Edmund

    2010-04-01

    Full Text Available Abstract Background Existing evidence indicates that once mature neonates with severe cardio-respiratory failure become eligible for Extra Corporeal Membrane Oxygenation (ECMO their chances of intact survival are doubled if they actually receive ECMO. However, significant numbers survive with disability. NEST is a multi-centre randomised controlled trial designed to test whether, in neonates requiring ECMO, cooling to 34°C for the first 48 to 72 hours of their ECMO course leads to improved later health status. Infants allocated to the control group will receive ECMO at 37°C throughout their course, which is currently standard practice around the world. Health status of both groups will be assessed formally at 2 years corrected age. Methods/Design All infants recruited to the study will be cared for in one of the four United Kingdom (UK ECMO centres. Babies who are thought to be eligible will be assessed by the treating clinician who will confirm eligibility, ensure that consent has been obtained and then randomise the baby using a web based system, based at the National Perinatal Epidemiology Unit (NPEU Clinical Trials Unit. Trial registration. Babies allocated ECMO without cooling will receive ECMO at 37°C ± 0.2°C. Babies allocated ECMO with cooling will be managed at 34°C ± 0.2°C for up to 72 hours from the start of their ECMO run. The minimum duration of cooling will be 48 hours. Rewarming (to 37°C will occur at a rate of no more than 0.5°C per hour. All other aspects of ECMO management will be identical. Primary outcome: Cognitive score from the Bayley Scales of Infant and Toddler Development, 3rd edition (Bayley-III at age of 2 years (24 - 27 months. Discussion For the primary analysis, children will be analysed in the groups to which they are assigned, comparing the outcome of all babies allocated to "ECMO with cooling" with all those allocated to "ECMO" alone, regardless of deviation from the protocol or treatment received. For

  15. THE ROLE OF INFORMATION TECHNOLOGIES IN THE PROCESS OF PROFESSIONAL TRAINING OF CADETS OF NATIONAL GUARD TROOPS OF THE RUSSIAN FEDERATION

    Directory of Open Access Journals (Sweden)

    O. A. Kozlov

    2016-01-01

    Full Text Available The purpose of this article is to identify the role of information technology in daily process of training of cadets of military schools of national guard troops of theRussian Federation.Methods. The methods involve system-oriented analysis, generalization and modelling.Results and scientific novelty. Informatization of modern society is characterized by growing use of information resources for different spheres of professional activity, suggesting radical changes in the content and technologies of its organization. The problems of informatization of the Russian higher military school are revealed: absence of the uniform methodology for implementation of new information technologies in educational process; low level of cooperation and coordination of activities of educational institutions during creation of a uniform basis of the software; insufficient training of the faculty, etc. The informatization process of military service and military experts of national guard troops of theRussian Federation as members of the security institute in the structure of the state is primarily associated with the creation and maintenance of necessary level of the equipment in order to solve professional tasks in various conditions of the operational environment. Modern realias dictate the need of search of ways and means of improvement of information literacy of cadets of departmental higher education institutions of national guard troops of theRussian Federation. The author of article has designated the main directions of intensive informatization of education of future army officers. The system use of a complex of information technologies of the general and special purpose in educational process of military higher education institution is described. The options of integration of these technologies in the contents of training sections of military experts are shown. Special attention is paid to opportunities of distance learning.Practical significance. The

  16. Cognitive Rehabilitation for Attention and Memory in people with Multiple Sclerosis: study protocol for a randomised controlled trial (CRAMMS).

    Science.gov (United States)

    Lincoln, Nadina B; das Nair, Roshan; Bradshaw, Lucy; Constantinescu, Cris S; Drummond, Avril E R; Erven, Alexandra; Evans, Amy L; Fitzsimmons, Deborah; Montgomery, Alan A; Morgan, Miriam

    2015-12-08

    People with multiple sclerosis have problems with memory and attention. Cognitive rehabilitation is a structured set of therapeutic activities designed to retrain an individual's memory and other cognitive functions. Cognitive rehabilitation may be provided to teach people strategies to cope with these problems, in order to reduce the impact on everyday life. The effectiveness of cognitive rehabilitation for people with multiple sclerosis has not been established. This is a multi-centre, randomised controlled trial investigating the clinical and cost-effectiveness of a group-based cognitive rehabilitation programme for attention and memory problems for people with multiple sclerosis. Four hundred people with multiple sclerosis will be randomised from at least four centres. Participants will be eligible if they have memory problems, are 18 to 69 years of age, are able to travel to attend group sessions and give informed consent. Participants will be randomised in a ratio of 6:5 to the group rehabilitation intervention plus usual care or usual care alone. Intervention groups will receive 10 weekly sessions of a manualised cognitive rehabilitation programme. The intervention will include both restitution strategies to retrain impaired attention and memory functions and compensation strategies to enable participants to cope with their cognitive problems. All participants will receive a follow-up questionnaire and an assessment by a research assistant at 6 and 12 months after randomisation. The primary outcome is the Multiple Sclerosis Impact Scale (MSIS) Psychological subscale at 12 months. Secondary outcomes include the Everyday Memory Questionnaire, General Health Questionnaire-30, EQ-5D and a service use questionnaire from participants, and the Everyday Memory Questionnaire-relative version and Carer Strain Index from a relative or friend. The primary analysis will be based on intention to treat. A mixed-model regression analysis of the MSIS Psychological

  17. 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

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

    Directory of Open Access Journals (Sweden)

    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

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

    Science.gov (United States)

    Coote, Susan; Garrett, Maria; Hogan, Neasa; Larkin, Aidan; Saunders, Jean

    2009-07-16

    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. 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 Ashworth Scale. Confounding variables such

  20. 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

  1. A prospective randomised trial comparing nasogastric with intravenous hydration in children with bronchiolitis (protocol The comparative rehydration in bronchiolitis study (CRIB

    Directory of Open Access Journals (Sweden)

    Borland Meredith

    2010-06-01

    Full Text Available Abstract Background Bronchiolitis is the most common reason for admission of infants to hospital in developed countries. Fluid replacement therapy is required in about 30% of children admitted with bronchiolitis. There are currently two techniques of fluid replacement therapy that are used with the same frequency-intravenous (IV or nasogastric (NG. The evidence to determine the optimum route of hydration therapy for infants with bronchiolitis is inadequate. This randomised trial will be the first to provide good quality evidence of whether nasogastric rehydration (NGR offers benefits over intravenous rehydration (IVR using the clinically relevant continuous outcome measure of duration of hospital admission. Methods/Design A prospective randomised multi-centre trial in Australia and New Zealand where children between 2 and 12 months of age with bronchiolitis, needing non oral fluid replacement, are randomised to receive either intravenous (IV or nasogastric (NG rehydration. 750 patients admitted to participating hospitals will be recruited, and will be followed daily during the admission and by telephone 1 week after discharge. Patients with chronic respiratory, cardiac, or neurological disease; choanal atresia; needing IV fluid resuscitation; needing an IV for other reasons, and those requiring CPAP or ventilation are excluded. The primary endpoint is duration of hospital admission. Secondary outcomes are complications, need for ICU admission, parental satisfaction, and an economic evaluation. Results will be analysed using t-test for continuous data, and chi squared for categorical data. Non parametric data will be log transformed. Discussion This trial will define the role of NGR and IVR in bronchiolitis Trail registration The trial is registered with the Australian and New Zealand Clinical Trials Registry - ACTRN12605000033640

  2. A prospective randomised trial comparing nasogastric with intravenous hydration in children with bronchiolitis (protocol) The comparative rehydration in bronchiolitis study (CRIB)

    Science.gov (United States)

    2010-01-01

    Background Bronchiolitis is the most common reason for admission of infants to hospital in developed countries. Fluid replacement therapy is required in about 30% of children admitted with bronchiolitis. There are currently two techniques of fluid replacement therapy that are used with the same frequency-intravenous (IV) or nasogastric (NG). The evidence to determine the optimum route of hydration therapy for infants with bronchiolitis is inadequate. This randomised trial will be the first to provide good quality evidence of whether nasogastric rehydration (NGR) offers benefits over intravenous rehydration (IVR) using the clinically relevant continuous outcome measure of duration of hospital admission. Methods/Design A prospective randomised multi-centre trial in Australia and New Zealand where children between 2 and 12 months of age with bronchiolitis, needing non oral fluid replacement, are randomised to receive either intravenous (IV) or nasogastric (NG) rehydration. 750 patients admitted to participating hospitals will be recruited, and will be followed daily during the admission and by telephone 1 week after discharge. Patients with chronic respiratory, cardiac, or neurological disease; choanal atresia; needing IV fluid resuscitation; needing an IV for other reasons, and those requiring CPAP or ventilation are excluded. The primary endpoint is duration of hospital admission. Secondary outcomes are complications, need for ICU admission, parental satisfaction, and an economic evaluation. Results will be analysed using t-test for continuous data, and chi squared for categorical data. Non parametric data will be log transformed. Discussion This trial will define the role of NGR and IVR in bronchiolitis Trail registration The trial is registered with the Australian and New Zealand Clinical Trials Registry - ACTRN12605000033640 PMID:20515467

  3. 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

    Directory of Open Access Journals (Sweden)

    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.

  4. 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

    Science.gov (United States)

    Brealey, Stephen D; Atwell, Christine; Bryan, Stirling; Coulton, Simon; Cox, Helen; Cross, Ben; Fylan, Fiona; Garratt, Andrew; Gilbert, Fiona J; Gillan, Maureen GC; Hendry, Maggie; Hood, Kerenza; Houston, Helen; King, David; Morton, Veronica; Orchard, Jo; Robling, Michael; Russell, Ian T; Torgerson, David; Wadsworth, Valerie; Wilkinson, Clare

    2006-01-01

    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. PMID:17040558

  5. A randomised controlled trial of six weeks of home enteral nutrition versus standard care after oesophagectomy or total gastrectomy for cancer: report on a pilot and feasibility study.

    Science.gov (United States)

    Bowrey, David J; Baker, Melanie; Halliday, Vanessa; Thomas, Anne L; Pulikottil-Jacob, Ruth; Smith, Karen; Morris, Tom; Ring, Arne

    2015-11-21

    Poor nutrition in the first months after oesophago-gastric resection is a contributing factor to the reduced quality of life seen in these patients. The aim of this pilot and feasibility study was to ascertain the feasibility of conducting a multi-centre randomised controlled trial to evaluate routine home enteral nutrition in these patients. Patients undergoing oesophagectomy or total gastrectomy were randomised to either six weeks of home feeding through a jejunostomy (intervention), or treatment as usual (control). Intervention comprised overnight feeding, providing 50 % of energy and protein requirements, in addition to usual oral intake. Primary outcome measures were recruitment and retention rates at six weeks and six months. Nutritional intake, nutritional parameters, quality of life and healthcare costs were also collected. Interviews were conducted with a sample of participants, to ascertain patient and carer experiences. Fifty-four of 112 (48 %) eligible patients participated in the study over the 20 months. Study retention at six weeks was 41/54 patients (76 %) and at six months was 36/54 (67 %). At six weeks, participants in the control group had lost on average 3.9 kg more than participants in the intervention group (95 % confidence interval [CI] 1.6 to 6.2). These differences remained evident at three months (mean difference 2.5 kg, 95 % CI -0.5 to 5.6) and at six months (mean difference 2.5 kg, 95 % CI -1.2 to 6.1). The mean values observed in the intervention group for mid arm circumference, mid arm muscle circumference, triceps skin fold thickness and right hand grip strength were greater than for the control group at all post hospital discharge time points. The economic evaluation suggested that it was feasible to collect resource use and EQ-5D data for a full cost-effectiveness analysis. Thematic analysis of 15 interviews identified three main themes related to the intervention and the trial: 1) a positive experience, 2) the reasons for taking

  6. The second Symptom Management Research Trial in Oncology (SMaRT Oncology-2): a randomised trial to determine the effectiveness and cost-effectiveness of adding a complex intervention for major depressive disorder to usual care for cancer patients.

    Science.gov (United States)

    Walker, Jane; Cassidy, Jim; Sharpe, Michael

    2009-03-30

    Depression Care for People with 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. In a 'proof of concept' trial (Symptom Management Research Trials in Oncology-1) Depression Care for People with Cancer improved depression more than usual care alone. The second Symptom Management Research Trial in Oncology (SMaRT Oncology-2 Trial) will test its effectiveness and cost-effectiveness in a 'real world' setting. A two arm parallel group multi-centre randomised controlled trial. TRIAL PROCEDURES: 500 patients will be recruited through established systematic Symptom Monitoring Services, which screen patients for depression. Patients will have: a diagnosis of cancer (of various types); an estimated life expectancy of twelve 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 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 'treatment response' measured at 24 week outcome data collection. 'Treatment response' will be defined as a reduction of 50% or more in the patient's baseline depression score, measured using the 20-item Symptom Checklist (SCL-20D). Secondary outcomes include remission of major depressive disorder, depression severity and patients' self-rated improvement of depression. Current controlled trials ISRCTN40568538 TRIAL HYPOTHESES: (1) Depression Care for People with Cancer as a supplement to usual care will be more effective than usual care alone in achieving a 50% reduction in baseline SCL-20D score at 24 weeks. (2) Depression Care for People with Cancer as a supplement to usual care will cost more than usual care alone but will be

  7. 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

  8. PREVIEW: Prevention of Diabetes through Lifestyle Intervention and Population Studies in Europe and around the World. Design, Methods, and Baseline Participant Description of an Adult Cohort Enrolled into a Three-Year Randomised Clinical Trial

    Directory of Open Access Journals (Sweden)

    Mikael Fogelholm

    2017-06-01

    Full Text Available Type-2 diabetes (T2D is one of the fastest growing chronic diseases worldwide. The PREVIEW project has been initiated to find the most effective lifestyle (diet and physical activity for the prevention of T2D, in overweight and obese participants with increased risk for T2D. The study is a three-year multi-centre, 2 × 2 factorial, randomised controlled trial. The impact of a high-protein, low-glycaemic index (GI vs. moderate protein, moderate-GI diet in combination with moderate or high-intensity physical activity on the incidence of T2D and the related clinical end-points are investigated. The intervention started with a two-month weight reduction using a low-calorie diet, followed by a randomised 34-month weight maintenance phase comprising four treatment arms. Eight intervention centres are participating (Denmark, Finland, United Kingdom, The Netherlands, Spain, Bulgaria, Australia, and New Zealand. Data from blood specimens, urine, faeces, questionnaires, diaries, body composition assessments, and accelerometers are collected at months 0, 2, 6, 12, 18, 24, and 36. In total, 2326 adults were recruited. The mean age was 51.6 (SD 11.6 years, 67% were women. PREVIEW is, to date, the largest multinational trial to address the prevention of T2D in pre-diabetic adults through diet and exercise intervention. Participants will complete the final intervention in March, 2018.

  9. PREVIEW: Prevention of Diabetes through Lifestyle Intervention and Population Studies in Europe and around the World. Design, Methods, and Baseline Participant Description of an Adult Cohort Enrolled into a Three-Year Randomised Clinical Trial

    Science.gov (United States)

    Fogelholm, Mikael; Larsen, Thomas Meinert; Westerterp-Plantenga, Margriet; Macdonald, Ian; Martinez, J. Alfredo; Boyadjieva, Nadka; Poppitt, Sally; Schlicht, Wolfgang; Stratton, Gareth; Sundvall, Jouko; Lam, Tony; Jalo, Elli; Christensen, Pia; Drummen, Mathijs; Simpson, Elizabeth; Navas-Carretero, Santiago; Handjieva-Darlenska, Teodora; Muirhead, Roslyn; Silvestre, Marta P.; Kahlert, Daniela; Pastor-Sanz, Laura; Brand-Miller, Jennie; Raben, Anne

    2017-01-01

    Type-2 diabetes (T2D) is one of the fastest growing chronic diseases worldwide. The PREVIEW project has been initiated to find the most effective lifestyle (diet and physical activity) for the prevention of T2D, in overweight and obese participants with increased risk for T2D. The study is a three-year multi-centre, 2 × 2 factorial, randomised controlled trial. The impact of a high-protein, low-glycaemic index (GI) vs. moderate protein, moderate-GI diet in combination with moderate or high-intensity physical activity on the incidence of T2D and the related clinical end-points are investigated. The intervention started with a two-month weight reduction using a low-calorie diet, followed by a randomised 34-month weight maintenance phase comprising four treatment arms. Eight intervention centres are participating (Denmark, Finland, United Kingdom, The Netherlands, Spain, Bulgaria, Australia, and New Zealand). Data from blood specimens, urine, faeces, questionnaires, diaries, body composition assessments, and accelerometers are collected at months 0, 2, 6, 12, 18, 24, and 36. In total, 2326 adults were recruited. The mean age was 51.6 (SD 11.6) years, 67% were women. PREVIEW is, to date, the largest multinational trial to address the prevention of T2D in pre-diabetic adults through diet and exercise intervention. Participants will complete the final intervention in March, 2018. PMID:28632180

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    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. Un estudio descriptivo de las características técnicas, físicas y motivacionales de las escuelas deportivas de futbol (alevines, infantiles y cadetes)

    OpenAIRE

    Mercé Cervera, Juan Jesús

    2003-01-01

    RESUMEN El fútbol es el deporte que mayor número de incondicionales arrastra, y de entre ellos destacan los niños, a quienes no sólo les gusta seguirlo, sino además practicarlo. Partiendo de ello, el objetivo general del trabajo ha sido analizar la condición física, las habilidades técnicas, y motivacionales de los participantes en las escuelas deportivas de fútbol (alevines, infantiles y cadetes) de la provincia de Valencia. Para lograr el objetivo indicado, hemos diseñado un estudi...

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

    Science.gov (United States)

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

    2014-08-16

    Current academic literature suggests that school gardening programmes can provide an interactive environment with the potential to change children's fruit and vegetable intake. This is the first cluster randomised controlled trial (RCT) designed to evaluate whether a school gardening programme can have an effect on children's fruit and vegetable intake. The trial included children from 23 schools; these schools were randomised into two groups, one to receive the Royal Horticultural Society (RHS)-led intervention and the other to receive the less involved Teacher-led intervention. A 24-hour food diary (CADET) was used to collect baseline and follow-up dietary intake 18 months apart. Questionnaires were also administered to evaluate the intervention implementation. A total of 641 children completed the trial with a mean age of 8.1 years (95% CI: 8.0, 8.4). The unadjusted results from multilevel regression analysis revealed that for combined daily fruit and vegetable intake the Teacher-led group had a higher daily mean change of 8 g (95% CI: -19, 36) compared to the RHS-led group -32 g (95% CI: -60, -3). However, after adjusting for possible confounders this difference was not significant (intervention effect: -40 g, 95% CI: -88, 1; p = 0.06). The adjusted analysis of process measures identified that if schools improved their gardening score by 3 levels (a measure of school gardening involvement - the scale has 6 levels from 0 'no garden' to 5 'community involvement'), irrespective of group allocation, children had, on average, a daily increase of 81 g of fruit and vegetable intake (95% CI: 0, 163; p = 0.05) compared to schools that had no change in gardening score. This study is the first cluster randomised controlled trial designed to evaluate a school gardening intervention. The results have found very little evidence to support the claims that school gardening alone can improve children's daily fruit and vegetable intake. However, when a gardening

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

    International Nuclear Information System (INIS)

    Fogarty, Gerald; Shivalingam, Brindha; Dhillon, Haryana; Thompson, John F; Morton, Rachael L; Vardy, Janette; Nowak, Anna K; Mandel, Catherine; Forder, Peta M; Hong, Angela; Hruby, George; Burmeister, Bryan

    2011-01-01

    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

  15. The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Birnbaum, Simone; Hogrel, Jean-Yves; Porcher, Raphael; Portero, Pierre; Clair, Bernard; Eymard, Bruno; Demeret, Sophie; Bassez, Guillaume; Gargiulo, Marcela; Louët, Estelle; Berrih-Aknin, Sonia; Jobic, Asmaa; Aegerter, Philippe; Thoumie, Philippe; Sharshar, Tarek

    2018-01-18

    Research exploring the effects of physical exercise in auto-immune myasthenia gravis (MG) is scarce. The few existing studies present methodological shortcomings limiting the conclusions and generalisability of results. It is hypothesised that exercise could have positive physical, psychological as well as immunomodulatory effects and may be a beneficial addition to current pharmacological management of this chronic disease. The aim of this study is to evaluate the benefits on perceived quality of life (QOL) and physical fitness of a home-based physical exercise program compared to usual care, for patients with stabilised, generalised auto-immune MG. MGEX is a multi-centre, interventional, randomised, single-blind, two-arm parallel group, controlled trial. Forty-two patients will be recruited, aged 18-70 years. Following a three-month observation period, patients will be randomised into a control or experimental group. The experimental group will undertake a 40-min home-based physical exercise program using a rowing machine, three times a week for three months, as an add-on to usual care. The control group will receive usual care with no additional treatment. All patients will be followed up for a further three months. The primary outcome is the mean change in MGQOL-15-F score between three and six months (i.e. pre-intervention and immediately post-intervention periods). The MGQOL-15-F is an MG-specific patient-reported QOL questionnaire. Secondary outcomes include the evaluation of deficits and functional limitations via MG-specific clinical scores (Myasthenia Muscle Score and MG-Activities of Daily Living scale), muscle force and fatigue, respiratory function, free-living physical activity as well as evaluations of anxiety, depression, self-esteem and overall QOL with the WHO-QOL BREF questionnaire. Exercise workload will be assessed as well as multiple safety measures (ECG, biological markers, medication type and dosage and any disease exacerbation or crisis

  16. A randomised controlled trial of three or one breathing technique training sessions for breathlessness in people with malignant lung disease.

    Science.gov (United States)

    Johnson, Miriam J; Kanaan, Mona; Richardson, Gerry; Nabb, Samantha; Torgerson, David; English, Anne; Barton, Rachael; Booth, Sara

    2015-09-07

    About 90 % of patients with intra-thoracic malignancy experience breathlessness. Breathing training is helpful, but it is unknown whether repeated sessions are needed. The present study aims to test whether three sessions are better than one for breathlessness in this population. This is a multi-centre randomised controlled non-blinded parallel arm trial. Participants were allocated to three sessions or single (1:2 ratio) using central computer-generated block randomisation by an independent Trials Unit and stratified for centre. The setting was respiratory, oncology or palliative care clinics at eight UK centres. Inclusion criteria were people with intrathoracic cancer and refractory breathlessness, expected prognosis ≥3 months, and no prior experience of breathing training. The trial intervention was a complex breathlessness intervention (breathing training, anxiety management, relaxation, pacing, and prioritisation) delivered over three hour-long sessions at weekly intervals, or during a single hour-long session. The main primary outcome was worst breathlessness over the previous 24 hours ('worst'), by numerical rating scale (0 = none; 10 = worst imaginable). Our primary analysis was area under the curve (AUC) 'worst' from baseline to 4 weeks. All analyses were by intention to treat. Between April 2011 and October 2013, 156 consenting participants were randomised (52 three; 104 single). Overall, the 'worst' score reduced from 6.81 (SD, 1.89) to 5.84 (2.39). Primary analysis [n = 124 (79 %)], showed no between-arm difference in the AUC: three sessions 22.86 (7.12) vs single session 22.58 (7.10); P value = 0.83); mean difference 0.2, 95 % CIs (-2.31 to 2.97). Complete case analysis showed a non-significant reduction in QALYs with three sessions (mean difference -0.006, 95 % CIs -0.018 to 0.006). Sensitivity analyses found similar results. The probability of the single session being cost-effective (threshold value of £20,000 per QALY) was over 80 %. There was no

  17. A self-managed single exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy: a randomised controlled trial (the SELF study).

    Science.gov (United States)

    Littlewood, Chris; Bateman, Marcus; Brown, Kim; Bury, Julie; Mawson, Sue; May, Stephen; Walters, Stephen J

    2016-07-01

    To evaluate the clinical effectiveness of a self-managed single exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy. Multi-centre pragmatic unblinded parallel group randomised controlled trial. UK National Health Service. Patients with a clinical diagnosis of rotator cuff tendinopathy. The intervention was a programme of self-managed exercise prescribed by a physiotherapist in relation to the most symptomatic shoulder movement. The control group received usual physiotherapy treatment. The primary outcome measure was the Shoulder Pain & Disability Index (SPADI) at three months. Secondary outcomes included the SPADI at six and twelve months. A total of 86 patients (self-managed loaded exercise n=42; usual physiotherapy n=44) were randomised. Twenty-six patients were excluded from the analysis because of lack of primary outcome data at the 3 months follow-up, leaving 60 (n=27; n=33) patients for intention to treat analysis. For the primary outcome, the mean SPADI score at three months was 32.4 (SD 20.2) for the self-managed group, and 30.7 (SD 19.7) for the usual physiotherapy treatment group; mean difference adjusted for baseline score: 3.2 (95% Confidence interval -6.0 to +12.4 P = 0.49).By six and twelve months there remained no significant difference between the groups. This study does not provide sufficient evidence of superiority of one intervention over the other in the short-, mid- or long-term and hence a self-management programme based around a single exercise appears comparable to usual physiotherapy treatment. © The Author(s) 2015.

  18. 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.

  19. 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

  20. Group treatments for sensitive health care problems: a randomised controlled trial of group versus individual physiotherapy sessions for female urinary incontinence

    Directory of Open Access Journals (Sweden)

    Clark MD

    2009-09-01

    Full Text Available Abstract Background The aim was to compare effectiveness of group versus individual sessions of physiotherapy in terms of symptoms, quality of life, and costs, and to investigate the effect of patient preference on uptake and outcome of treatment. Methods A pragmatic, multi-centre randomised controlled trial in five British National Health Service physiotherapy departments. 174 women with stress and/or urge incontinence were randomised to receive treatment from a physiotherapist delivered in a group or individual setting over three weekly sessions. Outcome were measured as Symptom Severity Index; Incontinence-related Quality of Life questionnaire; National Health Service costs, and out of pocket expenses. Results The majority of women expressed no preference (55% or preference for individual treatment (36%. Treatment attendance was good, with similar attendance with both service delivery models. Overall, there were no statistically significant differences in symptom severity or quality of life outcomes between the models. Over 85% of women reported a subjective benefit of treatment, with a slightly higher rating in the individual compared with the group setting. When all health care costs were considered, average cost per patient was lower for group sessions (Mean cost difference £52.91 95%, confidence interval (£25.82 - £80.00. Conclusion Indications are that whilst some women may have an initial preference for individual treatment, there are no substantial differences in the symptom, quality of life outcomes or non-attendance. Because of the significant difference in mean cost, group treatment is recommended. Trial Registration Trial Registration number: ISRCTN 16772662

  1. Prevention of Decline in Cognition after Stroke Trial (PODCAST): a study protocol for a factorial randomised controlled trial of intensive versus guideline lowering of blood pressure and lipids

    Science.gov (United States)

    2013-01-01

    Background Stroke is a common cause of cognitive impairment and dementia. However, effective strategies for reducing the risk of post-stroke dementia remain undefined. Potential strategies include intensive lowering of blood pressure and/or lipids. Methods/Design Design: multi-centre prospective randomised open-label blinded-endpoint controlled partial-factorial phase IV trial in secondary and primary care. Participants: 100 participants from 30 UK Stroke Research Network sites who are post- ischemic stroke or intracerebral haemorrhage by three to seven months. Interventions - all patients (1:1): intensive versus guideline blood pressure lowering (target systolic cognitive decline and dementia in people with ischemic stroke; and does ‘intensive’ blood pressure lowering therapy reduce cognitive decline and dementia in patients with hemorrhagic stroke. Primary outcome: Addenbrooke’s Cognitive Examination-Revised. Secondary outcomes: feasibility of recruitment and retention of participants, tolerability and safety of the interventions, achieving and maintaining the blood pressure and lipid targets, maintaining differences in systolic blood pressure (> 10 mmHg) and low density lipoprotein-cholesterol (> 1 mmol/l) between the treatment groups, and performing clinic and telephone follow-up of cognition measures. Randomisation: using stratification, minimization and simple randomization. Blinding: participants receive open-label management. Cognition is assessed both unblinded (in clinic) and blinded (by telephone) to treatment. Adjudication of events (dementia, vascular, serious adverse events) is blinded to management. Discussion The PODCAST trial is ongoing with 78 patients recruited to date from 22 sites. Outcomes of cognitive impairment and dementia are accruing. Trial registration ISRCTN85562386 PMID:24266960

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

    Science.gov (United States)

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

    2015-02-03

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

  3. Prevention and treatment of long-term social disability amongst young people with emerging severe mental illness with social recovery therapy (The PRODIGY Trial): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Fowler, David; French, Paul; Banerjee, Robin; Barton, Garry; Berry, Clio; Byrne, Rory; Clarke, Timothy; Fraser, Rick; Gee, Brioney; Greenwood, Kathryn; Notley, Caitlin; Parker, Sophie; Shepstone, Lee; Wilson, Jon; Yung, Alison R; Hodgekins, Joanne

    2017-07-11

    Young people who have social disability associated with severe and complex mental health problems are an important group in need of early intervention. Their problems often date back to childhood and become chronic at an early age. Without intervention, the long-term prognosis is often poor and the economic costs very large. There is a major gap in the provision of evidence-based interventions for this group, and therefore new approaches to detection and intervention are needed. This trial provides a definitive evaluation of a new approach to early intervention with young people with social disability and severe and complex mental health problems using social recovery therapy (SRT) over a period of 9 months to improve mental health and social recovery outcomes. This is a pragmatic, multi-centre, single blind, superiority randomised controlled trial. It is conducted in three sites in the UK: Sussex, Manchester and East Anglia. Participants are aged 16 to 25 and have both persistent and severe social disability (defined as engaged in less than 30 hours per week of structured activity) and severe and complex mental health problems. The target sample size is 270 participants, providing 135 participants in each trial arm. Participants are randomised 1:1 using a web-based randomisation system and allocated to either SRT plus optimised treatment as usual (enhanced standard care) or enhanced standard care alone. The primary outcome is time use, namely hours spent in structured activity per week at 15 months post-randomisation. Secondary outcomes assess typical mental health problems of the group, including subthreshold psychotic symptoms, negative symptoms, depression and anxiety. Time use, secondary outcomes and health economic measures are assessed at 9, 15 and 24 months post-randomisation. This definitive trial will be the first to evaluate a novel psychological treatment for social disability and mental health problems in young people presenting with social

  4. A nested mechanistic sub-study into the effect of tranexamic acid versus placebo on intracranial haemorrhage and cerebral ischaemia in isolated traumatic brain injury: study protocol for a randomised controlled trial (CRASH-3 Trial Intracranial Bleeding Mechanistic Sub-Study [CRASH-3 IBMS]).

    Science.gov (United States)

    Mahmood, Abda; Roberts, Ian; Shakur, Haleema

    2017-07-17

    Tranexamic acid prevents blood clots from breaking down and reduces bleeding. However, it is uncertain whether tranexamic acid is effective in traumatic brain injury. The CRASH-3 trial is a randomised controlled trial that will examine the effect of tranexamic acid (versus placebo) on death and disability in 13,000 patients with traumatic brain injury. The CRASH-3 trial hypothesizes that tranexamic acid will reduce intracranial haemorrhage, which will reduce the risk of death. Although it is possible that tranexamic acid will reduce intracranial bleeding, there is also a potential for harm. In particular, tranexamic acid may increase the risk of cerebral thrombosis and ischaemia. The protocol detailed here is for a mechanistic sub-study nested within the CRASH-3 trial. This mechanistic sub-study aims to examine the effect of tranexamic acid (versus placebo) on intracranial bleeding and cerebral ischaemia. The CRASH-3 Intracranial Bleeding Mechanistic Sub-Study (CRASH-3 IBMS) is nested within a prospective, double-blind, multi-centre, parallel-arm randomised trial called the CRASH-3 trial. The CRASH-3 IBMS will be conducted in a cohort of approximately 1000 isolated traumatic brain injury patients enrolled in the CRASH-3 trial. In the CRASH-3 IBMS, brain scans acquired before and after randomisation are examined, using validated methods, for evidence of intracranial bleeding and cerebral ischaemia. The primary outcome is the total volume of intracranial bleeding measured on computed tomography after randomisation, adjusting for baseline bleeding volume. Secondary outcomes include progression of intracranial haemorrhage (from pre- to post-randomisation scans), new intracranial haemorrhage (seen on post- but not pre-randomisation scans), intracranial haemorrhage following neurosurgery, and new focal ischaemic lesions (seen on post-but not pre-randomisation scans). A linear regression model will examine whether receipt of the trial treatment can predict haemorrhage

  5. 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

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

    International Nuclear Information System (INIS)

    Hurt, Christopher N; Nixon, Lisette S; Griffiths, Gareth O; Al-Mokhtar, Ruby; Gollins, Simon; Staffurth, John N; Phillips, Ceri J; Blazeby, Jane M; Crosby, Tom D

    2011-01-01

    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. 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 stage will recruit a further 120 patients into each arm

  7. 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

  8. 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

  9. 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

  10. BCG+MMC trial: adding mitomycin C to BCG as adjuvant intravesical therapy for high-risk, non-muscle-invasive bladder cancer: a randomised phase III trial (ANZUP 1301)

    International Nuclear Information System (INIS)

    Hayne, Dickon; Stockler, Martin; McCombie, Steve P.; Chalasani, Venu; Long, Anne; Martin, Andrew; Sengupta, Shomik; Davis, Ian D.

    2015-01-01

    Despite adequate trans-urethral resection of the bladder tumour (TURBT), non-muscle-invasive bladder cancer (NMIBC) is associated with high rates of recurrence and progression. Instillation of Bacillus Calmette-Guérin (BCG) into the urinary bladder after TURBT (adjuvant intravesical administration) reduces the risk of both recurrence and progression, and this is therefore the standard of care for high-risk tumours. However, over 30 % of people still recur or progress despite optimal delivery of BCG. Our meta-analysis suggests that outcomes might be improved further by using an adjuvant intravesical regimen that includes both mitomycin and BCG. These promising findings require corroboration in a definitive, large scale, randomised phase III trial using standard techniques for intravesical administration. The BCG + MMC trial (ANZUP 1301) is an open-label, randomised, stratified, two-arm multi-centre phase III trial comparing the efficacy and safety of standard intravesical therapy (BCG alone) against experimental intravesical therapy (BCG and mitomycin) in the treatment of adults with resected, high-risk NMIBC. Participants in the control group receive standard treatment with induction (weekly BCG for six weeks) followed by maintenance (four-weekly BCG for ten months). Participants in the experimental group receive induction (BCG weeks 1, 2, 4, 5, 7, and 8; mitomycin weeks 3, 6, and 9) followed by four-weekly maintenance (mitomycin weeks 13, 17, 25, 29, 37, and 41; BCG weeks 21, 33, and 45). The trial aims to include 500 participants who will be centrally randomised to one of the two treatment groups in a 1:1 ratio stratified by T-stage, presence of CIS, and study site. The primary endpoint is disease-free survival; secondary endpoints are disease activity, time to recurrence, time to progression, safety, health-related quality of life, overall survival, feasibility, and resource use

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

    Science.gov (United States)

    Kitchen, Meaghan S; Ransley, Joan K; Greenwood, Darren C; Clarke, Graham P; Conner, Mark T; Jupp, Jennifer; Cade, Janet E

    2009-06-16

    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. 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. 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. Medical Research Council Registry code G0501297.

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

    Science.gov (United States)

    Kitchen, Meaghan S; Ransley, Joan K; Greenwood, Darren C; Clarke, Graham P; Conner, Mark T; Jupp, Jennifer; Cade, Janet E

    2009-01-01

    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 PMID:19531246

  13. 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

  14. Decrease social inequalities return-to-work: development and design of a randomised controlled trial among women with breast cancer.

    Science.gov (United States)

    Vidor, Clémence; Leroyer, Ariane; Christophe, Véronique; Seillier, Mélanie; Foncel, Jérome; Van de Maële, Justine; Bonneterre, Jacques; Fantoni, Sophie

    2014-04-17

    Despite the improvement in the care management, women cancer patients who are still in employment find themselves for the most part obliged to stop working while they are having treatment. Their return-to-work probability is impacted by numerous psychosocial factors. The objective is to describe the development and the content of an intervention aimed to facilitate the return to work of female breast cancer patients and in particular the women in the most precarious situations through early active individualised psychosocial support (APAPI). The intervention proposed is made up of 4 interviews with a psychologist at the hospital, distributed over the year according to the diagnosis and conducted on the same day as a conventional follow-up consultation, then a consultation with a specialist job retention physician. We expect, in the first instance, that this intervention will reduce the social inequalities of the return-to-work rate at 12 months. The EPICES score will enable the population to be broken down according to the level of social precariousness. The other expected results are the reduction of the social inequalities in the quality of the return to work at 18 and 24 months and the disparities between the individual and collective resources of the patients. This intervention is assessed in the context of a controlled and randomised multi-centre study. The patients eligible are women aged between 18 and 55 years with a unilateral breast cancer with local extension exclusively, having received surgery followed by adjuvant chemotherapy, in employment at the time of the diagnosis and dealt with by one of the 2 investigating centres. It is essential to assess this type of intervention before envisaging its generalisation. The study set in place will enable us to measure the impact of this intervention aiming to facilitate the return to work of breast cancer patients, in particular for those who suffer from social fragility, compared with the standard care.

  15. Mesh fixation in endoscopic inguinal hernia repair: evaluation of methodology based on a systematic review of randomised clinical trials.

    Science.gov (United States)

    Lederhuber, Hans; Stiede, Franziska; Axer, Stephan; Dahlstrand, Ursula

    2017-11-01

    The issue of mesh fixation in endoscopic inguinal hernia repair is frequently debated and still no conclusive data exist on differences between methods regarding long-term outcome and postoperative complications. The quantity of trials and the simultaneous lack of high-quality evidence raise the question how future trials should be planned. PubMed, EMBASE and the Cochrane Library were searched, using the filters "randomised clinical trials" and "humans". Trials that compared one method of mesh fixation with another fixation method or with non-fixation in endoscopic inguinal hernia repair were eligible. To be included, the trial was required to have assessed at least one of the following primary outcome parameters: recurrence; surgical site infection; chronic pain; or quality-of-life. Fourteen trials assessing 2161 patients and 2562 hernia repairs were included. Only two trials were rated as low risk for bias. Eight trials evaluated recurrence or surgical site infection; none of these could show significant differences between methods of fixation. Two of 11 trials assessing chronic pain described significant differences between methods of fixation. One of two trials evaluating quality-of-life showed significant differences between fixation methods in certain functions. High-quality evidence for differences between the assessed mesh fixation techniques is still lacking. From a socioeconomic and ethical point of view, it is necessary that future trials will be properly designed. As small- and medium-sized single-centre trials have proven unable to find answers, register studies or multi-centre studies with an evident focus on methodology and study design are needed in order to answer questions about mesh fixation in inguinal hernia repair.

  16. Genetic Polymorphisms and Weight Loss in Obesity: A Randomised Trial of Hypo-Energetic High- versus Low-Fat Diets

    Science.gov (United States)

    Sørensen, Thorkild I. A; Boutin, Philippe; Taylor, Moira A; Larsen, Lesli H; Verdich, Camilla; Petersen, Liselotte; Holst, Claus; Echwald, Søren M; Dina, Christian; Toubro, Søren; Petersen, Martin; Polak, Jan; Clément, Karine; Martínez, J. Alfredo; Langin, Dominique; Oppert, Jean-Michel; Stich, Vladimir; Macdonald, Ian; Arner, Peter; Saris, Wim H. M; Pedersen, Oluf; Astrup, Arne; Froguel, Philippe

    2006-01-01

    Objectives: To study if genes with common single nucleotide polymorphisms (SNPs) associated with obesity-related phenotypes influence weight loss (WL) in obese individuals treated by a hypo-energetic low-fat or high-fat diet. Design: Randomised, parallel, two-arm, open-label multi-centre trial. Setting: Eight clinical centres in seven European countries. Participants: 771 obese adult individuals. Interventions: 10-wk dietary intervention to hypo-energetic (−600 kcal/d) diets with a targeted fat energy of 20%–25% or 40%–45%, completed in 648 participants. Outcome Measures: WL during the 10 wk in relation to genotypes of 42 SNPs in 26 candidate genes, probably associated with hypothalamic regulation of appetite, efficiency of energy expenditure, regulation of adipocyte differentiation and function, lipid and glucose metabolism, or production of adipocytokines, determined in 642 participants. Results: Compared with the noncarriers of each of the SNPs, and after adjusting for gender, age, baseline weight and centre, heterozygotes showed WL differences that ranged from −0.6 to 0.8 kg, and homozygotes, from −0.7 to 3.1 kg. Genotype-dependent additional WL on low-fat diet ranged from 1.9 to −1.6 kg in heterozygotes, and from 3.8 kg to −2.1 kg in homozygotes relative to the noncarriers. Considering the multiple testing conducted, none of the associations was statistically significant. Conclusions: Polymorphisms in a panel of obesity-related candidate genes play a minor role, if any, in modulating weight changes induced by a moderate hypo-energetic low-fat or high-fat diet. PMID:16871334

  17. 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

  18. Effectiveness and cost-effectiveness of transmural collaborative care with consultation letter (TCCCL) and duloxetine for major depressive disorder (MDD) and (sub)chronic pain in collaboration with primary care: design of a randomized placebo-controlled multi-Centre trial: TCC:PAINDIP.

    Science.gov (United States)

    de Heer, Eric W; Dekker, Jack; van Eck van der Sluijs, Jonna F; Beekman, Aartjan Tf; van Marwijk, Harm Wj; Holwerda, Tjalling J; Bet, Pierre M; Roth, Joost; Hakkaart-Van Roijen, Leona; Ringoir, Lianne; Kat, Fiona; van der Feltz-Cornelis, Christina M

    2013-05-24

    The comorbidity of pain and depression is associated with high disease burden for patients in terms of disability, wellbeing, and use of medical care. Patients with major and minor depression often present themselves with pain to a general practitioner and recognition of depression in such cases is low, but evolving. Also, physical symptoms, including pain, in major depressive disorder, predict a poorer response to treatment. A multi-faceted, patient-tailored treatment programme, like collaborative care, is promising. However, treatment of chronic pain conditions in depressive patients has, so far, received limited attention in research. Cost effectiveness of an integrated approach of pain in depressed patients has not been studied. This study is a placebo controlled double blind, three armed randomized multi centre trial. Patients with (sub)chronic pain and a depressive disorder are randomized to either a) collaborative care with duloxetine, b) collaborative care with placebo or c) duloxetine alone. 189 completers are needed to attain sufficient power to show a clinically significant effect of 0.6 SD on the primary outcome measures (PHQ-9 score). Data on depression, anxiety, mental and physical health, medication adherence, medication tolerability, quality of life, patient-doctor relationship, coping, health resource use and productivity will be collected at baseline and after three, six, nine and twelve months. This study enables us to show the value of a closely monitored integrated treatment model above usual pharmacological treatment. Furthermore, a comparison with a placebo arm enables us to evaluate effectiveness of duloxetine in this population in a real life setting. Also, this study will provide evidence-based treatments and tools for their implementation in practice. This will facilitate generalization and implementation of results of this study. Moreover, patients included in this study are screened for pain symptoms, differentiating between nociceptive

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

    Science.gov (United States)

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

    2018-02-06

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

  20. RADVAN: a randomised phase 2 trial of WBRT plus vandetanib for melanoma brain metastases – results and lessons learnt

    Science.gov (United States)

    Gupta, Avinash; Roberts, Corran; Tysoe, Finn; Goff, Matthew; Nobes, Jenny; Lester, James; Marshall, Ernie; Corner, Carie; Wolstenholme, Virginia; Kelly, Charles; Wise, Adelyn; Collins, Linda; Love, Sharon; Woodward, Martha; Salisbury, Amanda; Middleton, Mark R

    2016-01-01

    Background: Brain metastases occur in up to 75% of patients with advanced melanoma. Most are treated with whole-brain radiotherapy (WBRT), with limited effectiveness. Vandetanib, an inhibitor of vascular endothelial growth factor receptor, epidermal growth factor receptor and rearranged during transfection tyrosine kinases, is a potent radiosensitiser in xenograft models. We compared WBRT with WBRT plus vandetanib in the treatment of patients with melanoma brain metastases. Methods: In this double-blind, multi-centre, phase 2 trial patients with melanoma brain metastases were randomised to receive WBRT (30 Gy in 10 fractions) plus 3 weeks of concurrent vandetanib 100 mg once daily or placebo. The primary endpoint was progression-free survival in brain (PFS brain). The main study was preceded by a safety run-in phase to confirm tolerability of the combination. A post-hoc analysis and literature review considered barriers to recruiting patients with melanoma brain metastases to clinical trials. Results: Twenty-four patients were recruited, six to the safety phase and 18 to the randomised phase. The study closed early due to poor recruitment. Median PFS brain was 3.3 months (90% confidence interval (CI): 1.6–5.6) in the vandetanib group and 2.5 months (90% CI: 0.2–4.8) in the placebo group (P=0.34). Median overall survival (OS) was 4.6 months (90% CI: 1.6–6.3) and 2.5 months (90% CI: 0.2–7.2), respectively (P=0.54). The most frequent adverse events were fatigue, alopecia, confusion and nausea. The most common barrier to study recruitment was availability of alternative treatments. Conclusions: The combination of WBRT plus vandetanib was well tolerated. Compared with WBRT alone, there was no significant improvement in PFS brain or OS, although we are unable to provide a definitive result due to poor accrual. A review of barriers to trial accrual identified several factors that affect study recruitment in this difficult disease area. PMID:27711083

  1. RADVAN: a randomised phase 2 trial of WBRT plus vandetanib for melanoma brain metastases - results and lessons learnt.

    Science.gov (United States)

    Gupta, Avinash; Roberts, Corran; Tysoe, Finn; Goff, Matthew; Nobes, Jenny; Lester, James; Marshall, Ernie; Corner, Carie; Wolstenholme, Virginia; Kelly, Charles; Wise, Adelyn; Collins, Linda; Love, Sharon; Woodward, Martha; Salisbury, Amanda; Middleton, Mark R

    2016-11-08

    Brain metastases occur in up to 75% of patients with advanced melanoma. Most are treated with whole-brain radiotherapy (WBRT), with limited effectiveness. Vandetanib, an inhibitor of vascular endothelial growth factor receptor, epidermal growth factor receptor and rearranged during transfection tyrosine kinases, is a potent radiosensitiser in xenograft models. We compared WBRT with WBRT plus vandetanib in the treatment of patients with melanoma brain metastases. In this double-blind, multi-centre, phase 2 trial patients with melanoma brain metastases were randomised to receive WBRT (30 Gy in 10 fractions) plus 3 weeks of concurrent vandetanib 100 mg once daily or placebo. The primary endpoint was progression-free survival in brain (PFS brain). The main study was preceded by a safety run-in phase to confirm tolerability of the combination. A post-hoc analysis and literature review considered barriers to recruiting patients with melanoma brain metastases to clinical trials. Twenty-four patients were recruited, six to the safety phase and 18 to the randomised phase. The study closed early due to poor recruitment. Median PFS brain was 3.3 months (90% confidence interval (CI): 1.6-5.6) in the vandetanib group and 2.5 months (90% CI: 0.2-4.8) in the placebo group (P=0.34). Median overall survival (OS) was 4.6 months (90% CI: 1.6-6.3) and 2.5 months (90% CI: 0.2-7.2), respectively (P=0.54). The most frequent adverse events were fatigue, alopecia, confusion and nausea. The most common barrier to study recruitment was availability of alternative treatments. The combination of WBRT plus vandetanib was well tolerated. Compared with WBRT alone, there was no significant improvement in PFS brain or OS, although we are unable to provide a definitive result due to poor accrual. A review of barriers to trial accrual identified several factors that affect study recruitment in this difficult disease area.

  2. 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

  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. 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

  5. Clinical- and cost-effectiveness of the STAR care pathway compared to usual care for patients with chronic pain after total knee replacement: study protocol for a UK randomised controlled trial.

    Science.gov (United States)

    Wylde, Vikki; Bertram, Wendy; Beswick, Andrew D; Blom, Ashley W; Bruce, Julie; Burston, Amanda; Dennis, Jane; Garfield, Kirsty; Howells, Nicholas; Lane, Athene; McCabe, Candy; Moore, Andrew J; Noble, Sian; Peters, Tim J; Price, Andrew; Sanderson, Emily; Toms, Andrew D; Walsh, David A; White, Simon; Gooberman-Hill, Rachael

    2018-02-21

    Approximately 20% of patients experience chronic pain after total knee replacement. There is little evidence for effective interventions for the management of this pain, and current healthcare provision is patchy and inconsistent. Given the complexity of this condition, multimodal and individualised interventions matched to pain characteristics are needed. We have undertaken a comprehensive programme of work to develop a care pathway for patients with chronic pain after total knee replacement. This protocol describes the design of a randomised controlled trial to evaluate the clinical- and cost-effectiveness of a complex intervention care pathway compared with usual care. This is a pragmatic two-armed, open, multi-centred randomised controlled trial conducted within secondary care in the UK. Patients will be screened at 2 months after total knee replacement and 381 patients with chronic pain at 3 months postoperatively will be recruited. Recruitment processes will be optimised through qualitative research during a 6-month internal pilot phase. Patients are randomised using a 2:1 intervention:control allocation ratio. All participants receive usual care as provided by their hospital. The intervention comprises an assessment clinic appointment at 3 months postoperatively with an Extended Scope Practitioner and up to six telephone follow-up calls over 12 months. In the assessment clinic, a standardised protocol is followed to identify potential underlying causes for the chronic pain and enable appropriate onward referrals to existing services for targeted and individualised treatment. Outcomes are assessed by questionnaires at 6 and 12 months after randomisation. The co-primary outcomes are pain severity and pain interference assessed using the Brief Pain Inventory at 12 months after randomisation. Secondary outcomes relate to resource use, function, neuropathic pain, mental well-being, use of pain medications, satisfaction with pain relief, pain frequency, capability

  6. randomised trial of alternative malaria chemoprophylaxis strategies

    African Journals Online (AJOL)

    hi-tech

    2000-02-02

    Feb 2, 2000 ... randomisation produced comparable intervention and comparison groups with balanced characteristics. Specific results of the baseline studies are presented in the companion paper. ... strategies for protecting pregnant women against malaria. ..... from malaria vaccine trial conducted among Tanzanian.

  7. Multi-centre, multi-database studies with common protocols

    DEFF Research Database (Denmark)

    Klungel, Olaf H.; Kurz, Xavier; de Groot, Mark C.H.

    2016-01-01

    was observed depending on design, exposure and outcome definitions, but none of the differences were statistically significant. The association between anti-epileptics and suicidality was inconsistent across the UK CPRD, Danish National registries and the French PGRx system. Calcium channel blockers were...

  8. Multi-centre evaluation of two daily disposable contact lenses.

    Science.gov (United States)

    Walker, Jon; Young, Graeme; Hunt, Chris; Henderson, Terri

    2007-05-01

    To evaluate the clinical performance of two daily disposable contact lenses: 1-DAY ACUVUE (1DA) (etafilcon A, Johnson & Johnson Vision Care) and FOCUS DAILIES with AquaComfort (FD) (nelfilcon A, CIBA Vision, Inc.), which contains a quickly released moisture enhancing agent, polyvinyl alcohol (PVA). This was a 1-week, daily wear, subject-masked, bilateral, parallel group study with subjects randomly assigned to one of two daily disposable soft contact lenses. Subjects were existing soft contact lens wearers in the age range 18-39 years with a spherical refraction between -0.50 and -6.00 D. Subjects were assessed at baseline and after 1 week. Assessments included both subjective (symptoms, wearing time, vision) and objective (lens fit and ocular health) outcomes. Twenty clinical sites enrolled 282 subjects (74% female) of whom 276 (98%) successfully completed the study. Significantly more 1DA wearers reported higher mean comfort scores than with FD (3.95 versus 3.41, respectively, Pdisposable lenses highlight that, although both lenses may be considered as clinically acceptable, these lenses should not be regarded as interchangeable.

  9. Peptic Ulcer Disease in Bangladesh: A Multi-centre Study.

    Science.gov (United States)

    Ghosh, C K; Khan, M R; Alam, F; Shil, B C; Kabir, M S; Mahmuduzzaman, M; Das, S C; Masud, H; Roy, P K

    2017-01-01

    The incidence of peptic ulcer has steadily declined through out the world. This decreasing trend is also noticeable in this subcontinent. The point prevalence of peptic ulcer (PUD) in Bangladesh was around 15% in eighties. The aim of this study was to see the present prevalence of peptic ulcer at endoscopy and to identify changing trends in the occurrence of peptic ulcer in Bangladesh. This retrospective analysis of the endoscopic records of multiple tertiary referral centres of Dhaka city were done from January 2012 to July 2013. A total of 5608 subjects were the study samples. We included those patients having peptic ulcer in the form of duodenal ulcer, benign gastric ulcer including pre-pyloric ulcer and gastric outlet obstruction due to peptic ulcer. Duodenal ulcer and benign gastric ulcer were found in 415(7.4%) and 184(3.28%) patients respectively and gastric outlet obstruction due to peptic ulcer was found in 23(0.40%) patients.

  10. Validation of protein carbonyl measurement: A multi-centre study

    Directory of Open Access Journals (Sweden)

    Edyta Augustyniak

    2015-04-01

    Full Text Available Protein carbonyls are widely analysed as a measure of protein oxidation. Several different methods exist for their determination. A previous study had described orders of magnitude variance that existed when protein carbonyls were analysed in a single laboratory by ELISA using different commercial kits. We have further explored the potential causes of variance in carbonyl analysis in a ring study. A soluble protein fraction was prepared from rat liver and exposed to 0, 5 and 15 min of UV irradiation. Lyophilised preparations were distributed to six different laboratories that routinely undertook protein carbonyl analysis across Europe. ELISA and Western blotting techniques detected an increase in protein carbonyl formation between 0 and 5 min of UV irradiation irrespective of method used. After irradiation for 15 min, less oxidation was detected by half of the laboratories than after 5 min irradiation. Three of the four ELISA carbonyl results fell within 95% confidence intervals. Likely errors in calculating absolute carbonyl values may be attributed to differences in standardisation. Out of up to 88 proteins identified as containing carbonyl groups after tryptic cleavage of irradiated and control liver proteins, only seven were common in all three liver preparations. Lysine and arginine residues modified by carbonyls are likely to be resistant to tryptic proteolysis. Use of a cocktail of proteases may increase the recovery of oxidised peptides. In conclusion, standardisation is critical for carbonyl analysis and heavily oxidised proteins may not be effectively analysed by any existing technique.

  11. A multi-centre analysis of radiotherapy beam output measurement

    Directory of Open Access Journals (Sweden)

    Matthew A. Bolt

    2017-10-01

    Conclusions: Machine beam output measurements were largely within ±2% of 1.00 cGy/MU. Clear trends in measured output over time were seen, with some machines having large drifts which would result in additional burden to maintain within acceptable tolerances. This work may act as a baseline for future comparison of beam output measurements.

  12. 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

  13. Self-monitoring of Blood Glucose in Non-Insulin Treated Type 2 Diabetes (The SMBG Study): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Parsons, Sharon; Luzio, Stephen; Bain, Stephen; Harvey, John; McKenna, Jillian; Khan, Atir; Rice, Sam; Watkins, Alan; Owens, David R

    2017-01-26

    The benefit of Self-monitoring of Blood Glucose (SMBG) in people with non-insulin treated type 2 diabetes remains unclear with inconsistent evidence from randomised controlled trials fuelling the continued debate. Lack of a consistent finding has been attributed to variations in study population and design, including the SMBG intervention. There is a growing consensus that structured SMBG, whereby the person with diabetes and health care provider are educated to detect patterns of glycaemic abnormality and take appropriate action according to the blood glucose profiles, can prove beneficial in terms of lowering HbA1c and improving overall well-being. Despite this, many national health agencies continue to issue guidelines restricting the use of SMBG in non-insulin treated type 2 diabetes. The SMBG Study is a 12 month, multi-centre, randomised controlled trial in people with type 2 diabetes not on insulin therapy who have poor glycaemic control (HbA1c ≥58 mmol/mol / 7.5%). The participants will be randomised into three comparative groups: Group 1 will act as a control group and receive their usual diabetes care; Group 2 will undertake structured SMBG with clinical review every 3 months; Group 3 will undertake structured SMBG with additional monthly telecare support from a trained study nurse. A total of 450 participants will be recruited from 16 primary and secondary care sites across Wales and England. The primary outcome measure will be HbA1c at 12 months with secondary measures to include weight, BMI, total cholesterol and HbA1c levels at 3, 6, 9 and 12 months. Participant well-being and attitude towards SMBG will be monitored throughout the course of the study. Recruitment began in December 2012 with the last participant visit due in September 2016. This study will attempt to answer the question of whether structured SMBG provides any benefits to people with poorly controlled type 2 diabetes who are not being treated with insulin. The data will also

  14. START NOW - a comprehensive skills training programme for female adolescents with oppositional defiant and conduct disorders: study protocol for a cluster-randomised controlled trial.

    Science.gov (United States)

    Kersten, Linda; Prätzlich, Martin; Mannstadt, Sandra; Ackermann, Katharina; Kohls, Gregor; Oldenhof, Helena; Saure, Daniel; Krieger, Katrin; Herpertz-Dahlmann, Beate; Popma, Arne; Freitag, Christine M; Trestman, Robert L; Stadler, Christina

    2016-12-01

    In Europe, the number of females exhibiting oppositional defiant disorder (ODD) and conduct disorder (CD) is growing. Many of these females live in youth welfare institutions. Consequently, there is a great need for evidence-based interventions within youth welfare settings. A recently developed approach targeting the specific needs of girls with ODD and CD in residential care is START NOW. The aim of this group-based behavioural skills training programme is to specifically enhance emotional regulation capacities to enable females with CD or ODD to appropriately deal with daily-life demands. It is intended to enhance psychosocial adjustment and well-being as well as reduce oppositional and aggressive behaviour. We present the study protocol (version 4.1; 10 February 2016) of the FemNAT-CD intervention trial titled 'Group-Based Treatment of Adolescent Female Conduct Disorders: The Central Role of Emotion Regulation'. The study is a prospective, confirmatory, cluster-randomised, parallel-group, multi-centre, randomised controlled trial with 128 institutionalised female adolescents who fulfil the diagnostic criteria of ODD and/or CD. Institutions/wards will be randomised either to provide the 12-week skills training as an add-on intervention or to provide treatment as usual. Once the first cycle is completed, each institution will run a second cycle with the opposite condition. Primary endpoints are the pre-post change in number of CD/ODD symptoms as assessed by a standardised, semi-structured psychiatric interview (Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime, CD/ODD section) between baseline and the end of intervention, as well as between baseline and a 3-month follow-up point. Secondary objectives include pre-post change in CD/ODD-related outcome measures, most notably emotional regulation on a behavioural and neurobiological level after completion of START NOW compared with treatment as usual. To our

  15. 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].

    Science.gov (United States)

    2003-12-08

    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 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 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-year follow-up, although the medium-term and longer-term risks and benefits of LUNA will also be

  16. 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

  17. 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.

  18. Emergency treatment with levetiracetam or phenytoin in status epilepticus in children-the EcLiPSE study: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Lyttle, Mark D; Gamble, Carrol; Messahel, Shrouk; Hickey, Helen; Iyer, Anand; Woolfall, Kerry; Humphreys, Amy; Bacon, Naomi E A; Roper, Louise; Babl, Franz E; Dalziel, Stuart R; Ryan, Mary; Appleton, Richard E

    2017-06-19

    Convulsive status epilepticus (CSE) is the most common life-threatening neurological emergency in childhood. These children are also at risk of significant morbidity, with acute and chronic impact on the family and the health and social care systems. The current recommended first-choice, second-line treatment in children aged 6 months and above is intravenous phenytoin (fosphenytoin in the USA), although there is a lack of evidence for its use and it is associated with significant side effects. Emerging evidence suggests that intravenous levetiracetam may be effective as a second-line agent for CSE, and fewer adverse effects have been described. This trial therefore aims to determine whether intravenous phenytoin or levetiracetam is more effective, and safer, in treating childhood CSE. This is a phase IV, multi-centre, parallel group, randomised controlled, open-label trial. Following treatment for CSE with first-line treatment, children with ongoing seizures are randomised to receive either phenytoin (20 mg/kg, maximum 2 g) or levetiracetam (40 mg/kg, maximum 2.5 g) intravenously. The primary outcome measure is the cessation of all visible signs of CSE as determined by the treating clinician. Secondary outcome measures include the need for further anti-seizure medications or rapid sequence induction for ongoing CSE, admission to critical care areas, and serious adverse reactions. Patients are recruited without prior consent, with deferred consent sought at an appropriate time for the family. The primary analysis will be by intention-to-treat. The primary outcome is a time to event outcome and a sample size of 140 participants in each group will have 80% power to detect an increase in CSE cessation rates from 60% to 75%. Our total sample size of 308 randomised and treated participants will allow for 10% loss to follow-up. This clinical trial will determine whether phenytoin or levetiracetam is more effective as an intravenous second-line agent for CSE, and

  19. The effectiveness of ICT-based neurocognitive and psychosocial rehabilitation programmes in people with mild dementia and mild cognitive impairment using GRADIOR and ehcoBUTLER: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Vanova, Martina; Irazoki, Eider; García-Casal, J Antonio; Martínez-Abad, Fernando; Botella, Cristina; Shiells, Kate R; Franco-Martín, Manuel A

    2018-02-12

    Cognitive rehabilitation is a highly individualised, non-pharmacological intervention for people with mild cognitive impairment (MCI) and dementia, which in recent years has also been developed for various IT platforms. In this study, we aim to evaluate the effectiveness of the cognitive rehabilitation software GRADIOR in a multi-centre, single-blinded randomised controlled trial with people with MCI and mild dementia. A total of 400 people with MCI and mild dementia will be randomly allocated to one of four groups. This trial will compare the cognitive rehabilitation treatment using the GRADIOR programme with a psychosocial stimulation intervention (PSS) using the ehcoBUTLER platform, with a combined treatment consisting of GRADIOR and ehcoBUTLER, and with a group receiving treatment as usual during a period of 1 year. The outcomes of this clinical trial will be to determine any relevant changes in cognition, mood, quality of life, activities of daily living and quality of patient-carer relationship after 4 months and 1 year of intervention in a cross-sectional group comparison. Participants will be followed-up for 1 year to investigate potential long-term effects of the conducted treatments. Current Controlled Trials ISRCTN, ID: 15742788 . Registered on 12 June 2017.

  20. The safety, effectiveness and cost-effectiveness of cytisine in achieving six-month continuous smoking abstinence in tuberculosis patients - protocol for a double-blind, placebo-controlled randomised trial.

    Science.gov (United States)

    Dogar, Omara; Barua, Deepa; Boeckmann, Melanie; Elsey, Helen; Fatima, Razia; Gabe, Rhian; Huque, Rumana; Keding, Ada; Khan, Amina; Kotz, Daniel; Kralikova, Eva; Newell, James N; Nohavova, Iveta; Parrott, Steve; Readshaw, Anne; Renwick, Lottie; Sheikh, Aziz; Siddiqi, Kamran

    2018-04-20

    Tuberculosis (TB) patients who quit smoking have much better disease outcomes than those who continue to smoke. Behavioural support combined with pharmacotherapy is the most effective strategy in helping people to quit, in general populations. However, there is no evidence for the effectiveness of this strategy in TB patients who smoke. We will assess the safety, effectiveness and cost-effectiveness of cytisine - a low-cost plant-derived nicotine substitute - for smoking cessation in TB patients compared with placebo, over and above brief behavioural support. Two-arm, parallel, double-blind, placebo-controlled, multi-centre (30 sites in Bangladesh and Pakistan), individually randomised trial. TB treatment centres integrated into public health care systems in Bangladesh and Pakistan. Newly diagnosed (in the last four weeks) adult pulmonary TB patients who are daily smokers (with or without dual smokeless tobacco use) and are interested in quitting (n= 2,388). The primary outcome measure is biochemically verified continuous abstinence from smoking at six months post-randomization, assessed using Russell Standard criteria. The secondary outcome measures include continuous abstinence at 12 months, lapses and relapses; clinical TB outcomes; nicotine dependency and withdrawal; and adverse events. This is the first smoking cessation trial of cytisine in low- and middle-income countries evaluating both cessation and tuberculosis (TB) outcomes. If found effective, cytisine could become the most affordable cessation intervention to help TB patients who smoke. This article is protected by copyright. All rights reserved.

  1. Community occupational therapy for people with dementia and family carers (COTiD-UK) versus treatment as usual (Valuing Active Life in Dementia [VALID] programme): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Wenborn, Jennifer; Hynes, Sinéad; Moniz-Cook, Esme; Mountain, Gail; Poland, Fiona; King, Michael; Omar, Rumana; Morris, Steven; Vernooij-Dassen, Myrra; Challis, David; Michie, Susan; Russell, Ian; Sackley, Catherine; Graff, Maud; O'Keeffe, Aidan; Crellin, Nadia; Orrell, Martin

    2016-02-03

    A community-based occupational therapy intervention for people with mild to moderate dementia and their family carers (Community Occupational Therapy in Dementia (COTiD)) was found clinically and cost effective in the Netherlands but not in Germany. This highlights the need to adapt and implement complex interventions to specific national contexts. The current trial aims to evaluate the United Kingdom-adapted occupational therapy intervention for people with mild to moderate dementia and their family carers living in the community (COTiD-UK) compared with treatment as usual. This study is a multi-centre, parallel-group, pragmatic randomised trial with internal pilot. We aim to allocate 480 pairs, with each pair comprising a person with mild to moderate dementia and a family carer, who provides at least 4 hours of practical support per week, at random between COTiD-UK and treatment as usual. We shall assess participants at baseline, 12 and 26 weeks, and by telephone at 52 and 78 weeks (first 40% of recruits only) after randomisation. The primary outcome measure is the Bristol Activities of Daily Living Scale (BADLS) at 26 weeks. Secondary outcome measures will include quality of life, mood, and resource use. To assess intervention delivery, and client experience, we shall collect qualitative data via audio recordings of COTiD-UK sessions and conduct semi-structured interviews with pairs and occupational therapists. COTiD-UK is an evidence-based person-centred intervention that reflects the current priority to enable people with dementia to remain in their own homes by improving their capabilities whilst reducing carer burden. If COTiD-UK is clinically and cost effective, this has major implications for the future delivery of dementia services across the UK. Current Controlled Trials ISRCTN10748953 Date of registration: 18 September 2014.

  2. 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.

  3. GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING): a pilot cluster randomised controlled trial of a guideline implementation intervention for the management of maternal obesity by midwives.

    Science.gov (United States)

    Heslehurst, Nicola; Rankin, Judith; McParlin, Catherine; Sniehotta, Falko F; Howel, Denise; Rice, Stephen; McColl, Elaine

    2018-01-01

    Weight management in pregnancy guidelines exist, although dissemination alone is an ineffective means of implementation. Midwives identify the need for support to overcome complex barriers to practice. An evaluation of an intervention to support midwives' guideline implementation would require a large-scale cluster randomised controlled trial. A pilot study is necessary to explore the feasibility of delivery and evaluation prior to a definitive trial. The GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING) trial aims to test whether it is feasible and acceptable to deliver a behaviour change intervention to support midwives' implementation of weight management guidelines. GLOWING is a multi-centre parallel group pilot cluster randomised controlled trial comparing the delivery of a behaviour change intervention for midwives versus usual practice. Four NHS Trusts (clusters) will be randomised to intervention and control arms, stratified by size of maternity services. The intervention uses social cognitive theory and consists of face-to-face midwifery training plus information resources for routine practice. The main outcomes are whether the intervention and trial procedures are feasible and acceptable to participants and the feasibility of recruitment and data collection for a definitive trial. Target recruitment involves all eligible midwives in the intervention arm recruited to receive the intervention, 30 midwives and pregnant women per arm for baseline and outcome questionnaire data collection and 20 midwives and women to provide qualitative data. All quantitative and qualitative analyses will be descriptive with the purpose of informing the development of the definitive trial. This pilot study has been developed to support community midwives' implementation of guidelines. Community midwives have been selected as they usually carry out the booking appointment which includes measuring and discussing maternal body mass index. A

  4. IQuaD dental trial; improving the quality of dentistry: a multicentre randomised controlled trial comparing oral hygiene advice and periodontal instrumentation for the prevention and management of periodontal disease in dentate adults attending dental primary care.

    Science.gov (United States)

    Clarkson, Jan E; Ramsay, Craig R; Averley, Paul; Bonetti, Debbie; Boyers, Dwayne; Campbell, Louise; Chadwick, Graham R; Duncan, Anne; Elders, Andrew; Gouick, Jill; Hall, Andrew F; Heasman, Lynne; Heasman, Peter A; Hodge, Penny J; Jones, Clare; Laird, Marilyn; Lamont, Thomas J; Lovelock, Laura A; Madden, Isobel; McCombes, Wendy; McCracken, Giles I; McDonald, Alison M; McPherson, Gladys; Macpherson, Lorna E; Mitchell, Fiona E; Norrie, John Dt; Pitts, Nigel B; van der Pol, Marjon; Ricketts, David Nj; Ross, Margaret K; Steele, James G; Swan, Moira; Tickle, Martin; Watt, Pauline D; Worthington, Helen V; Young, Linda

    2013-10-26

    Periodontal disease is the most common oral disease affecting adults, and although it is largely preventable it remains the major cause of poor oral health worldwide. Accumulation of microbial dental plaque is the primary aetiological factor for both periodontal disease and caries. Effective self-care (tooth brushing and interdental aids) for plaque control and removal of risk factors such as calculus, which can only be removed by periodontal instrumentation (PI), are considered necessary to prevent and treat periodontal disease thereby maintaining periodontal health. Despite evidence of an association between sustained, good oral hygiene and a low incidence of periodontal disease and caries in adults there is a lack of strong and reliable evidence to inform clinicians of the relative effectiveness (if any) of different types of Oral Hygiene Advice (OHA). The evidence to inform clinicians of the effectiveness and optimal frequency of PI is also mixed. There is therefore an urgent need to assess the relative effectiveness of OHA and PI in a robust, sufficiently powered randomised controlled trial (RCT) in primary dental care. This is a 5 year multi-centre, randomised, open trial with blinded outcome evaluation based in dental primary care in Scotland and the North East of England. Practitioners will recruit 1860 adult patients, with periodontal health, gingivitis or moderate periodontitis (Basic Periodontal Examination Score 0-3). Dental practices will be cluster randomised to provide routine OHA or Personalised OHA. To test the effects of PI each individual patient participant will be randomised to one of three groups: no PI, 6 monthly PI (current practice), or 12 monthly PI.Baseline measures and outcome data (during a three year follow-up) will be assessed through clinical examination, patient questionnaires and NHS databases.The primary outcome measures at 3 year follow up are gingival inflammation/bleeding on probing at the gingival margin; oral hygiene self

  5. IQuaD dental trial; improving the quality of dentistry: a multicentre randomised controlled trial comparing oral hygiene advice and periodontal instrumentation for the prevention and management of periodontal disease in dentate adults attending dental primary care

    Science.gov (United States)

    2013-01-01

    Background Periodontal disease is the most common oral disease affecting adults, and although it is largely preventable it remains the major cause of poor oral health worldwide. Accumulation of microbial dental plaque is the primary aetiological factor for both periodontal disease and caries. Effective self-care (tooth brushing and interdental aids) for plaque control and removal of risk factors such as calculus, which can only be removed by periodontal instrumentation (PI), are considered necessary to prevent and treat periodontal disease thereby maintaining periodontal health. Despite evidence of an association between sustained, good oral hygiene and a low incidence of periodontal disease and caries in adults there is a lack of strong and reliable evidence to inform clinicians of the relative effectiveness (if any) of different types of Oral Hygiene Advice (OHA). The evidence to inform clinicians of the effectiveness and optimal frequency of PI is also mixed. There is therefore an urgent need to assess the relative effectiveness of OHA and PI in a robust, sufficiently powered randomised controlled trial (RCT) in primary dental care. Methods/Design This is a 5 year multi-centre, randomised, open trial with blinded outcome evaluation based in dental primary care in Scotland and the North East of England. Practitioners will recruit 1860 adult patients, with periodontal health, gingivitis or moderate periodontitis (Basic Periodontal Examination Score 0–3). Dental practices will be cluster randomised to provide routine OHA or Personalised OHA. To test the effects of PI each individual patient participant will be randomised to one of three groups: no PI, 6 monthly PI (current practice), or 12 monthly PI. Baseline measures and outcome data (during a three year follow-up) will be assessed through clinical examination, patient questionnaires and NHS databases. The primary outcome measures at 3 year follow up are gingival inflammation/bleeding on probing at the

  6. 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

  7. 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

  8. Informed, advance refusals of treatment by people with severe mental illness in a randomised controlled trial of joint crisis plans: demand, content and correlates.

    Science.gov (United States)

    Henderson, Claire; Farrelly, Simone; Flach, Clare; Borschmann, Rohan; Birchwood, Max; Thornicroft, Graham; Waheed, Waquas; Szmukler, George

    2017-11-24

    In the UK, crisis planning for mental health care should acknowledge the right to make an informed advance treatment refusal under the Mental Capacity Act 2005. Our aims were to estimate the demand for such treatment refusals within a sample of service users who had had a recent hospital admission for psychosis or bipolar disorder, and to examine the relationship between refusals, and service user characteristics. To identify refusals we conducted content analysis of Joint Crisis Plans, which are plans formulated by service users and their clinical team with involvement from an external facilitator, and routine care plans in sub-samples from a multi-centre randomised controlled trial of Joint Crisis Plans (plus routine mental health care) versus routine care alone (CRIMSON) in England. Factors hypothesised to be associated with refusals were identified using the trial data collected through baseline interviews of service users and clinicians and collection of routine clinical data. Ninety-nine of 221 (45%) of the Joint Crisis Plans contained a treatment refusal compared to 10 of 424 (2.4%) baseline routine care plans. No Joint Crisis Plans recorded disagreement with refusals on the part of clinicians. Among those with completed Joint Crisis Plans, adjusted analyses indicated a significant association between treatment refusals and perceived coercion at baseline (odds ratio = 1.21, 95% CI 1.02-1.43), but not with baseline working alliance or a past history of involuntary admission. We demonstrated significant demand for written treatment refusals in line with the Mental Capacity Act 2005, which had not previously been elicited by the process of treatment planning. Future treatment/crisis plans should incorporate the opportunity for service users to record a treatment refusal during the drafting of such plans. ISRCTN11501328 Registered 13th March 2008.

  9. Transvaginal prolapse repair with or without the addition of a midurethral sling in women with genital prolapse and stress urinary incontinence: a randomised trial.

    Science.gov (United States)

    van der Ploeg, J M; Oude Rengerink, K; van der Steen, A; van Leeuwen, J H S; Stekelenburg, J; Bongers, M Y; Weemhoff, M; Mol, B W; van der Vaart, C H; Roovers, J-P W R

    2015-06-01

    To compare transvaginal prolapse repair combined with midurethral sling (MUS) versus prolapse repair only. Multi-centre randomised trial. Fourteen teaching hospitals in the Netherlands. Women with symptomatic stage two or greater pelvic organ prolapse (POP), and subjective or objective stress urinary incontinence (SUI) without prolapse reduction. Women were randomly assigned to undergo vaginal prolapse repair with or without MUS. Analysis was according to intention to treat. The primary outcome at 12 months' follow-up was the absence of urinary incontinence (UI) assessed with the Urogenital Distress Inventory and treatment for SUI or overactive bladder. Secondary outcomes included complications. One hundred and thirty-four women were analysed at 12 months' follow-up (63 in MUS and 71 in control group). More women in the MUS group reported the absence of UI and SUI; respectively 62% versus 30% UI (relative risk [RR] 2.09; 95% confidence interval [CI] 1.39-3.15) and 78% versus 39% SUI (RR 1.97; 95% CI 1.44-2.71). Fewer women underwent treatment for postoperative SUI in the MUS group (10% versus 37%; RR 0.26; 95% CI 0.11-0.59). In the control group, 12 women (17%) underwent MUS after prolapse surgery versus none in the MUS group. Severe complications were more common in the MUS group, but the difference was not statistically significant (16% versus 6%; RR 2.82; 95% CI 0.93-8.54). Women with prolapse and co-existing SUI are less likely to have SUI after transvaginal prolapse repair with MUS compared with prolapse repair only. However, only 17% of the women undergoing POP surgery needed additional MUS. A well-informed decision balancing risks and benefits of both strategies should be tailored to individual women. © 2015 Royal College of Obstetricians and Gynaecologists.

  10. The PD COMM trial: a protocol for the process evaluation of a randomised trial assessing the effectiveness of two types of SLT for people with Parkinson's disease.

    Science.gov (United States)

    Masterson-Algar, Patricia; Burton, Christopher R; Brady, Marian C; Nicoll, Avril; Clarke, Carl E; Rick, Caroline; Hughes, Max; Au, Pui; Smith, Christina H; Sackley, Catherine M

    2017-08-29

    The PD COMM trial is a phase III multi-centre randomised controlled trial whose aim is to evaluate the effectiveness and cost-effectiveness of two approaches to speech and language therapy (SLT) compared with no SLT intervention (control) for people with Parkinson's disease who have self-reported or carer-reported problems with their speech or voice. Our protocol describes the process evaluation embedded within the outcome evaluation whose aim is to evaluate what happened at the time of the PD COMM intervention implementation and to provide findings that will assist in the interpretation of the PD COMM trial results. Furthermore, the aim of the PD COMM process evaluation is to investigate intervention complexity within a theoretical model of how the trialled interventions might work best and why. Drawing from the Normalization Process Theory and frameworks for implementation fidelity, a mixed method design will be used to address process evaluation research questions. Therapists' and participants' perceptions and experiences will be investigated via in-depth interviews. Critical incident reports, baseline survey data from therapists, treatment record forms and home practice diaries also will be collected at relevant time points throughout the running of the PD COMM trial. Process evaluation data will be analysed independently of the outcome evaluation before the two sets of data are then combined. To date, there are a limited number of published process evaluation protocols, and few are linked to trials investigating rehabilitation therapies. Providing a strong theoretical framework underpinning design choices and being tailored to meet the complex characteristics of the trialled interventions, our process evaluation has the potential to provide valuable insight into which components of the interventions being delivered in PD COMM worked best (and what did not), how they worked well and why. ISRCTN Registry, ISRCTN12421382 . Registered on 18 April 2016.

  11. Patients as teachers: a randomised controlled trial on the use of personal stories of harm to raise awareness of patient safety for doctors in training.

    Science.gov (United States)

    Jha, Vikram; Buckley, Hannah; Gabe, Rhian; Kanaan, Mona; Lawton, Rebecca; Melville, Colin; Quinton, Naomi; Symons, Jools; Thompson, Zoe; Watt, Ian; Wright, John

    2015-01-01

    Patient safety training often provides learners with a health professional's perspective rather than the patient's. Personal narratives of health-related harm allow patients to share their stories with health professionals to influence clinical behaviour by rousing emotions and improving attitudes to safety. This study measured the impact of patient narratives used to train junior doctors in patient safety. An open, multi-centre, two-arm, parallel design randomised controlled trial was conducted in the North Yorkshire East Coast Foundation School (NYECFS). The intervention consisted of 1-h-long patient narratives followed by discussion. The control arm received conventional faculty-delivered teaching. The Attitude to Patient Safety Questionnaire (APSQ) and the Positive and Negative Affect Schedule (PANAS) were used to measure the impact of the intervention. 142 trainees received the intervention; 141 the control teaching. There was no evidence of a difference in post-intervention APSQ scores between the groups. There was a statistically significant difference in the underlying distribution of both post PA (positive affect) and post NA (negative affect) scores between the groups on the PANAS (pappeal and seems an obvious choice in designing safety interventions. On the basis of our primary outcome measure, we were unable to demonstrate effectiveness of the intervention in changing general attitudes to safety compared to control. While the intervention may impact on emotional engagement and learning about communication, we remain uncertain whether this will translate into improved behaviours in the clinical context or indeed if there are any negative effects. Grant reference no. RP-PG-0108-10049. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  12. Brote de histoplasmosis en la Escuela de Cadetes de la Base Aérea de Morón, Provincia de Buenos Aires, República Argentina Histoplasmosis outbreak in Morón, Buenos Aires Province, Argentina

    Directory of Open Access Journals (Sweden)

    R. Negroni

    2010-12-01

    Full Text Available Se describe un brote de histoplasmosis que afectó a 6 cadetes de la Fuerza Aérea Argentina, sin antecedentes patológicos previos. Todos consultaron por problemas respiratorios después de haber limpiado un hangar. En ese recinto se encontraron abundantes deyecciones de animales, presuntamente de palomas y murciélagos. Los pacientes sufrieron fiebre, mialgias, taquipnea y tos no productiva. Las radiografías y tomografías de tórax mostraron imágenes pulmonares micronodulares, engrosamiento de los tabiques interalveolares y adenopatías hiliares. Todos tuvieron una evolución favorable y no requirieron tratamiento antifúngico. Las pruebas de inmunodifusión y contrainmunoelectroforesis con antígenos de Histoplasma capsulatum fueron positivas, al igual que las intradermorreacciones con histoplasmina. Se recogieron 5 muestras de tierra del lugar, las que fueron inoculadas por vía intraperitoneal a 20 hámsteres. De los cultivos de hígado y bazo de dichos animales se consiguió aislar la fase micelial de H. capsulatum. La cepa aislada se comparó con las obtenidas de 12 pacientes argentinos utilizando perfiles genéticos y se observó un clado único con más de 96% de similitud, lo que confirma la homogeneidad de las cepas argentinas. Si bien la histoplasmosis es endémica en la Pampa húmeda, este es el primer brote totalmente documentado al sur del paralelo 34°.An histoplasmosis outbreak affecting 6 previously healthy Air Force cadets is herein presented. The patients suffered from fever and respiratory symptoms after having cleaned an abandoned hangar soiled with pigeons and bat droppings. They all presented fever, myalgia, tachypnea, and nonproductive cough. Chest X-ray and CT scan studies showed disseminated reticulonodular images affecting both lungs. Hiliar adenomegalies were also observed. All patients achieved a favourable outcome without antifungal treatment. Both serologic tests searching for specificic antibodies

  13. a randomised controlled trial oftwo prostaglandin regitnens

    African Journals Online (AJOL)

    Design. A prospective randomised controlled trial. Setting. Department of Obstetrics and Gynae- ... hours after the original administration of either prostaglandin regimen. If abortion had not taken place 36 .... Tygerberg Hospital for permission to publish, and Upjohn. (Pry) Ltd for supplying the Prepidil gel used in the study. 1.

  14. Is the randomised controlled trial the best?

    African Journals Online (AJOL)

    The randomised controlled trial (RCT) is recog nised as the gold standard of research methods, particularly to test efficacy. The primary benefit of the RCT, as everyone knows, is to prevent patient selection bias. And it should also guarantee some rigour of research methodology. It is always prospective. In a nonrandomised ...

  15. A Pragmatic Randomised, Controlled Trial of Intensive Care follow up programmes in improving Longer-term outcomes from critical illness. The PRACTICAL study

    Directory of Open Access Journals (Sweden)

    Ramsey Craig

    2007-07-01

    Full Text Available Abstract Background A number of intensive care (ICU patients experience significant problems with physical, psychological, and social functioning for some time after discharge from ICU. These problems have implications not just for patients, but impose a continuing financial burden for the National Health Service. To support recovery, a number of hospitals across the UK have developed Intensive Care follow-up clinics. However, there is a lack of evidence base to support these, and this study aims to test the hypothesis that intensive care follow up programmes are effective and cost-effective at improving physical and psychological quality of life in the year after intensive care discharge. Methods/Design This is a multi-centre, pragmatic, randomised controlled trial. Patients (n = 270 will be recruited prior to hospital discharge from three intensive care units in the UK, and randomised to one of two groups. The control group will receive standard in-hospital follow-up and the intervention group will participate in an ICU follow-up programme with clinic appointments 2–3 and 9 months after ICU discharge. The primary outcome measure is Health-related Quality of Life (HRQoL 12 months after ICU discharge as measured by the Short Form-36. Secondary measures include: HRQoL at six months; Quality-adjusted life years using EQ-5D; posttraumatic psychopathology as measured by Davidson Trauma Scale; and anxiety and depression using the Hospital Anxiety and Depression Scale at both six and twelve months after ICU discharge. Contacts with health services in the twelve months after ICU discharge will be measured as part of the economic analysis. Discussion The provision of intensive care follow-up clinics within the UK has developed in an ad hoc manner, is inconsistent in both the number of hospitals offering such a service or in the type of service offered. This study provides the opportunity to evaluate such services both in terms of patient benefit and

  16. Shared Decision Making in mental health care using Routine Outcome Monitoring as a source of information: a cluster randomised controlled trial.

    Science.gov (United States)

    Metz, Margot J; Franx, Gerdien C; Veerbeek, Marjolein A; de Beurs, Edwin; van der Feltz-Cornelis, Christina M; Beekman, Aartjan T F

    2015-12-15

    Shared Decision Making (SDM) is a way to empower patients when decisions are made about treatment. In order to be effective agents in this process, patients need access to information of good quality. Routine Outcome Monitoring (ROM) may provide such information and therefore may be a key element in SDM. This trial tests the effectiveness of SDM using ROM, primarily aiming to diminish decisional conflict of the patient while making decisions about treatment. The degree of decisional conflict, the primary outcome of this study, encompasses personal certainty about choosing an appropriate treatment, information about options, clarification of patient values, support from others and patients experience of an effective decision making process. Secondary outcomes of the study focus on the working alliance between patient and clinician, adherence to treatment, and clinical outcome and quality of life. This article presents the study protocol of a multi-centre two-arm cluster randomised controlled trial (RCT). The research is conducted in Dutch specialised mental health care teams participating in the ROM Quality Improvement Collaborative (QIC), which aims to implement ROM in daily clinical practice. In the intervention teams, ROM is used as a source of information during the SDM process between the patient and clinician. Control teams receive no specific SDM or ROM instructions and apply decision making as usual. Randomisation is conducted at the level of the participating teams within the mental health organisations. A total of 12 teams from 4 organisations and 364 patients participate in the study. Prior to data collection, the intervention teams are trained to use ROM during the SDM process. Data collection will be at baseline, and at 3 and 6 months after inclusion of the patient. Control teams will implement the SDM and ROM model after completion of the study. This study will provide useful information about the effectiveness of ROM within a SDM framework

  17. CASPER plus (CollAborative care in Screen-Positive EldeRs with major depressive disorder): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Overend, Karen; Lewis, Helen; Bailey, Della; Bosanquet, Kate; Chew-Graham, Carolyn; Ekers, David; Gascoyne, Samantha; Hems, Deborah; Holmes, John; Keding, Ada; McMillan, Dean; Meer, Shaista; Meredith, Jodi; Mitchell, Natasha; Nutbrown, Sarah; Parrott, Steve; Richards, David; Traviss, Gemma; Trépel, Dominic; Woodhouse, Rebecca; Gilbody, Simon

    2014-11-19

    Depression accounts for the greatest disease burden of all mental health disorders, contributes heavily to healthcare costs, and by 2020 is set to become the second largest cause of global disability. Although 10% to 16% of people aged 65 years and over are likely to experience depressive symptoms, the condition is under-diagnosed and often inadequately treated in primary care. Later-life depression is associated with chronic illness and disability, cognitive impairment and social isolation. With a progressively ageing population it becomes increasingly important to refine strategies to identity and manage depression in older people. Currently, management may be limited to the prescription of antidepressants where there may be poor concordance; older people may lack awareness of psychosocial interventions and general practitioners may neglect to offer this treatment option. CASPER Plus is a multi-centre, randomised controlled trial of a collaborative care intervention for individuals aged 65 years and over experiencing moderate to severe depression. Selected practices in the North of England identify potentially eligible patients and invite them to participate in the study. A diagnostic interview is carried out and participants with major depressive disorder are randomised to either collaborative care or usual care. The recruitment target is 450 participants. The intervention, behavioural activation and medication management in a collaborative care framework, has been adapted to meet the complex needs of older people. It is delivered over eight to 10 weekly sessions by a case manager liaising with general practitioners. The trial aims to evaluate the clinical and cost effectiveness of collaborative care in addition to usual GP care versus usual GP care alone. The primary clinical outcome, depression severity, will be measured with the Patient Health Questionnaire-9 (PHQ-9) at baseline, 4, 12 and 18 months. Cost effectiveness analysis will assess health

  18. Functional electrical stimulation cycling does not improve mobility in people with acquired brain injury and its effects on strength are unclear: a randomised trial

    Directory of Open Access Journals (Sweden)

    Davide G de Sousa

    2016-10-01

    Full Text Available Question: Does 4 weeks of active functional electrical stimulation (FES cycling in addition to usual care improve mobility and strength more than usual care alone in people with a sub-acute acquired brain injury caused by stroke or trauma? Design: Multi centre, randomised, controlled trial. Participants: Forty patients from three Sydney hospitals with recently acquired brain injury and a mean composite strength score in the affected lower limb of 7 (SD 5 out of 20 points. Intervention: Participants in the experimental group received an incremental, progressive, FES cycling program five times a week over a 4-week period. All participants received usual care. Outcome measures: Outcome measures were taken at baseline and at 4 weeks. Primary outcomes were mobility and strength of the knee extensors of the affected lower limb. Mobility was measured with three mobility items of the Functional Independence Measure and strength was measured with a hand-held dynamometer. Secondary outcomes were strength of the knee extensors of the unaffected lower limb, strength of key muscles of the affected lower limb and spasticity of the affected plantar flexors. Results: All but one participant completed the study. The mean between-group differences for mobility and strength of the knee extensors of the affected lower limb were –0.3/21 points (95% CI –3.2 to 2.7 and 7.5 Nm (95% CI –5.1 to 20.2, where positive values favoured the experimental group. The only secondary outcome that suggested a possible treatment effect was strength of key muscles of the affected lower limb with a mean between-group difference of 3.0/20 points (95% CI 1.3 to 4.8. Conclusion: Functional electrical stimulation cycling does not improve mobility in people with acquired brain injury and its effects on strength are unclear. Trial registration: ACTRN12612001163897. [de Sousa DG, Harvey LA, Dorsch S, Leung J, Harris W (2016 Functional electrical stimulation cycling does not improve

  19. 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

  20. 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.

  1. Randomised controlled trials in Scandinavian educational research

    DEFF Research Database (Denmark)

    Pontoppidan, Maiken; Keilow, Maria; Dietrichson, Jens

    2018-01-01

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

  2. Acute pancreatitis: recent advances through randomised trials.

    Science.gov (United States)

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

    2017-11-01

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

  3. 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

  4. Protocol for a double-blind randomised placebo-controlled trial of lithium carbonate in patients with amyotrophic lateral sclerosis (LiCALS) [Eudract number: 2008-006891-31].

    Science.gov (United States)

    Al-Chalabi, Ammar; Shaw, Pamela J; Young, Carolyn A; Morrison, Karen E; Murphy, Caroline; Thornhill, Marie; Kelly, Joanna; Steen, I Nicholas; Leigh, P Nigel

    2011-09-21

    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. 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 capacity ≥ 60% of predicted within 1 month prior to

  5. 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

  6. A multicentre, pragmatic, parallel group, randomised controlled trial to compare the clinical and cost-effectiveness of three physiotherapy-led exercise interventions for knee osteoarthritis in older adults: the BEEP trial protocol (ISRCTN: 93634563).

    Science.gov (United States)

    Foster, Nadine E; Healey, Emma L; Holden, Melanie A; Nicholls, Elaine; Whitehurst, David Gt; Jowett, Susan; Jinks, Clare; Roddy, Edward; Hay, Elaine M

    2014-07-27

    Exercise is consistently recommended for older adults with knee pain related to osteoarthritis. However, the effects from exercise are typically small and short-term, likely linked to insufficient individualisation of the exercise programme and limited attention to supporting exercise adherence over time. The BEEP randomised trial aims to improve patients' short and long-term outcomes from exercise. It will test the overall effectiveness and cost-effectiveness of two physiotherapy-led exercise interventions (Individually Tailored Exercise and Targeted Exercise Adherence) to improve the individual tailoring of, and adherence to exercise, compared with usual physiotherapy care. Based on the learning from a pilot study (ISRCTN 23294263), the BEEP trial is a multi-centre, pragmatic, parallel group, individually randomised controlled trial, with embedded longitudinal qualitative interviews. 500 adults in primary care, aged 45 years and over with knee pain will be randomised to 1 of 3 treatment groups delivered by fully trained physiotherapists in up to 6 NHS services. These are: Usual Physiotherapy Care (control group consisting of up to 4 treatment sessions of advice and exercise), Individually Tailored Exercise (an individualised, supervised and progressed lower-limb exercise programme) or Targeted Exercise Adherence (supporting patients to adhere to exercise and to engage in general physical activity over the longer-term). The primary outcomes are pain and function as measured by the Western Ontario and McMaster Osteoarthritis index. A comprehensive range of secondary outcomes are also included. Outcomes are measured at 3, 6 (primary outcome time-point), 9, 18 and 36 months. Data on adverse events will also be collected. Semi-structured, qualitative interviews with a subsample of 30 participants (10 from each treatment group) will be undertaken at two time-points (end of treatment and 12 to 18 months later) and analysed thematically. This trial will contribute to the

  7. 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.

    Science.gov (United States)

    Selvaraj, Francis Jude; Mohamed, Mafauzy; Omar, Khairani; Nanthan, Sudha; Kusiar, Zainab; Subramaniam, Selvaraj Y; Ali, Norsiah; Karanakaran, Kamalakaran; Ahmad, Fauziah; Low, Wilson H H

    2012-10-10

    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). 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. 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 ended). Patients who received coaching and advice from

  8. 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

  9. Strategies to improve recruitment to randomised trials.

    Science.gov (United States)

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

    2018-02-22

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

  10. 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

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

    Science.gov (United States)

    2012-01-01

    Background Acute lateral ankle ligament injuries are very common problems in present health care. Still there is no hard evidence about which treatment strategy is superior. Current evidence supports the view that a functional treatment strategy is preferable, but insufficient data are present to prove the benefit of external support devices in these types of treatment. The hypothesis of our study is that external ankle support devices will not result in better outcome in the treatment of acute ankle sprains, compared to a purely functional treatment strategy. Overall objective is to compare the results of three different strategies of functional treatment for acute ankle sprain, especially to determine the advantages of external support devices in addition to functional treatment strategy, based on balance and coordination exercises. Methods/design This study is designed as a randomised controlled multi-centre trial with one-year follow-up. Adult and healthy patients (N = 180) with acute, single sided and first inversion trauma of the lateral ankle ligaments will be included. They will all follow the same schedule of balancing exercises and will be divided into 3 treatment groups, 1. pressure bandage and tape, 2. pressure bandage and brace and 3. no external support. Primary outcome measure is the Karlsson scoring scale; secondary outcomes are FAOS (subscales), number of recurrent ankle injuries, Visual Analogue Scales of pain and satisfaction and adverse events. They will be measured after one week, 6 weeks, 6 months and 1 year. Discussion The ANKLE TRIAL is a randomized controlled trial in which a purely functional treated control group, without any external support is investigated. Results of this study could lead to other opinions about usefulness of external support devices in the treatment of acute ankle sprain. Trial registration Netherlands Trial Register (NTR): NTR2151 PMID:22340371

  12. A protocol for a randomised controlled trial of prefabricated versus customised foot orthoses for people with rheumatoid arthritis: the FOCOS RA trial [Foot Orthoses - Customised v Off-the-Shelf in Rheumatoid Arthritis].

    Science.gov (United States)

    Gallagher, Kellie S; Godwin, Jon; Hendry, Gordon J; Steultjens, Martijn; Woodburn, Jim

    2018-01-01

    Foot pain is common in rheumatoid arthritis and appears to persist despite modern day medical management. Several clinical practice guidelines currently recommend the use of foot orthoses for the treatment of foot pain in people with rheumatoid arthritis. However, an evidence gap currently exists concerning the comparative clinical- and cost-effectiveness of prefabricated and customised foot orthoses in people with early rheumatoid arthritis. Early intervention with orthotics may offer the best opportunity for positive therapeutic outcomes. The primary aim of this study is to evaluate the comparative clinical- and cost-effectiveness of prefabricated versus customised orthoses for reducing foot pain over 12 months. This is a multi-centre two-arm parallel randomised controlled trial comparing prefabricated versus customised orthoses in participants with early rheumatoid arthritis (rheumatoid arthritis, global functional status via the Stanford Health Assessment Questionnaire, foot disease activity via the Rheumatoid Arthritis Foot Disease Activity Index, and health-related quality of life at baseline, 6 and 12 months. Process outcomes will include recruitment/retention rates, data completion rates, intervention adherence rates, and participant intervention and trial participation satisfaction. Cost-utility and cost-effectiveness analyses will be undertaken. Outcome measures collected at baseline, 6 and 12 months will be used to evaluate the comparative clinical- and cost- effectiveness of customised versus prefabricated orthoses for this treatment of early rheumatoid arthritis foot conditions. This trial will help to guide orthotic prescription recommendations for the management of foot pain for people with early rheumatoid arthritis in future. ISRCTN13654421. Registered 09 February 2016.

  13. Bevacizumab and Combination Chemotherapy in rectal cancer Until Surgery (BACCHUS): a phase II, multicentre, open-label, randomised study of neoadjuvant chemotherapy alone in patients with high-risk cancer of the rectum

    International Nuclear Information System (INIS)

    Glynne-Jones, R.; Hava, N.; Goh, V.; Bosompem, S.; Bridgewater, J.

    2015-01-01

    In locally advanced rectal cancer (LARC) preoperative chemoradiation (CRT) is the standard of care, but the risk of local recurrence is low with good quality total mesorectal excision (TME), although many still develop metastatic disease. Current challenges in treating rectal cancer include the development of effective organ-preserving approaches and the prevention of subsequent metastatic disease. Neoadjuvant systemic chemotherapy (NACT) alone may reduce local and systemic recurrences, and may be more effective than postoperative treatments which often have poor compliance. Investigation of intensified NACT is warranted to improve outcomes for patients with LARC. The objective is to evaluate feasibility and efficacy of a four-drug regimen containing bevacizumab prior to surgical resection. This is a multi-centre, randomized phase II trial. Eligible patients must have histologically confirmed LARC with distal part of the tumour 4–12 cm from anal verge, no metastases, and poor prognostic features on pelvic MRI. Sixty patients will be randomly assigned in a 1:1 ratio to receive folinic acid + flurourcil + oxaliplatin (FOLFOX) + bevacizumab (BVZ) or FOLFOX + irinotecan (FOLFOXIRI) + BVZ, given in 2 weekly cycles for up to 6 cycles prior to TME. Patients stop treatment if they fail to respond after 3 cycles (defined as ≥ 30 % decrease in Standardised Uptake Value (SUV) compared to baseline PET/CT). The primary endpoint is pathological complete response rate. Secondary endpoints include objective response rate, MRI tumour regression grade, involved circumferential resection margin rate, T and N stage downstaging, progression-free survival, disease-free survival, overall survival, local control, 1-year colostomy rate, acute toxicity, compliance to chemotherapy. In LARC, a neoadjuvant chemotherapy regimen - if feasible, effective and tolerable would be suitable for testing as the novel arm against the current standards of short course preoperative radiotherapy (SCPRT

  14. Randomised trial of biofeedback training for encopresis.

    Science.gov (United States)

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

    1996-01-01

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

  15. Strategies to improve retention in randomised trials

    Science.gov (United States)

    Brueton, Valerie C; Tierney, Jayne; Stenning, Sally; Harding, Seeromanie; Meredith, Sarah; Nazareth, Irwin; Rait, Greta

    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 methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PreMEDLINE, EMBASE, PsycINFO, DARE, CINAHL, Campbell Collaboration's Social, Psychological, Educational and Criminological Trials Register, and ERIC. We handsearched conference proceedings and publication reference lists for eligible retention trials. We also surveyed all UK Clinical Trials Units to identify further studies. Selection criteria We included eligible retention trials of randomised or quasi-randomised evaluations of strategies to increase retention that were embedded in 'host' randomised trials from all disease areas and healthcare settings. We excluded studies aiming to increase treatment compliance. Data collection and analysis We contacted authors to supplement or confirm data that we had extracted. For retention trials, we recorded data on the method of randomisation, type of strategy evaluated, comparator, primary outcome, planned sample size, numbers randomised and numbers retained. We used risk ratios (RR) to evaluate the effectiveness of the addition of strategies to improve retention. We assessed heterogeneity between trials using the Chi2 and I2 statistics. For main trials that hosted retention trials, we extracted data on disease area, intervention, population, healthcare setting, sequence generation and allocation concealment. Main results We identified 38 eligible retention trials. Included trials evaluated six broad types of strategies to improve retention. These

  16. MENOS4 trial: a multicentre randomised controlled trial (RCT) of a breast care nurse delivered cognitive behavioural therapy (CBT) intervention to reduce the impact of hot flushes in women with breast cancer: Study Protocol.

    Science.gov (United States)

    Fenlon, Deborah; Nuttall, Jacqueline; May, Carl; Raftery, James; Fields, Jo; Kirkpatrick, Emma; Abab, Julia; Ellis, Mary; Rose, Taylor; Khambhaita, Priya; Galanopoulou, Angeliki; Maishman, Tom; Haviland, Jo; Griffiths, Gareth; Turner, Lesley; Hunter, Myra

    2018-05-08

    Women who have been treated for breast cancer may identify vasomotor symptoms, such as hot flushes and night sweats (HFNS), as a serious problem. HFNS are unpleasant to experience and can have a significant impact on daily life, potentially leading to reduced adherence to life saving adjuvant hormonal therapy. It is known that Cognitive Behavioural Therapy (CBT) is effective for the alleviation of hot flushes in both well women and women who have had breast cancer. Most women with breast cancer will see a breast care nurse and there is evidence that nurses can be trained to deliver psychological treatments to a satisfactory level, whilst also maintaining treatment fidelity. The research team will assess whether breast care nurses can effectively deliver a CBT intervention to alleviate hot flushes in women with breast cancer. This study is a multi-centre phase III individually randomised controlled trial of group CBT versus usual care to reduce the impact of hot flushes in women with breast cancer. 120-160 women with primary breast cancer experiencing seven or more problematic HFNS a week will be randomised to receive either treatment as usual (TAU) or participation in the group CBT intervention plus TAU (CBT Group). A process evaluation using May's Normalisation Process Theory will be conducted, as well as practical and organisational issues relating to the implementation of the intervention. Fidelity of implementation of the intervention will be conducted by expert assessment. The cost effectiveness of the intervention will also be assessed. There is a need for studies that enable effective interventions to be implemented in practice. There is good evidence that CBT is helpful for women with breast cancer who experience HFNS, yet it is not widely available. It is not yet known whether the intervention can be effectively delivered by breast care nurses or implemented in practice. This study will provide information on both whether the intervention can effectively

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

    Science.gov (United States)

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

    2010-05-18

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

  18. A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting - rationale, design and baseline characteristics.

    Science.gov (United States)

    Laurence, Caroline; Gialamas, Angela; Yelland, Lisa; Bubner, Tanya; Ryan, Philip; Willson, Kristyn; Glastonbury, Briony; Gill, Janice; Shephard, Mark; Beilby, Justin

    2008-08-06

    Point of care testing (PoCT) may be a useful adjunct in the management of chronic conditions in general practice (GP). The provision of pathology test results at the time of the consultation could lead to enhanced clinical management, better health outcomes, greater convenience and satisfaction for patients and general practitioners (GPs), and savings in costs and time. It could also result in inappropriate testing, increased consultations and poor health outcomes resulting from inaccurate results. Currently there are very few randomised controlled trials (RCTs) in GP that have investigated these aspects of PoCT. The Point of Care Testing in General Practice Trial (PoCT Trial) was an Australian Government funded multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost effectiveness and satisfaction of PoCT in a GP setting.The PoCT Trial covered an 18 month period with the intervention consisting of the use of PoCT for seven tests used in the management of patients with diabetes, hyperlipidaemia and patients on anticoagulant therapy. The primary outcome measure was the proportion of patients within target range, a measure of therapeutic control. In addition, the PoCT Trial investigated the safety of PoCT, impact of PoCT on patient compliance to medication, stakeholder satisfaction, cost effectiveness of PoCT versus laboratory testing, and influence of geographic location. The paper provides an overview of the Trial Design, the rationale for the research methodology chosen and how the Trial was implemented in a GP environment. The evaluation protocol and data collection processes took into account the large number of patients, the broad range of practice types distributed over a large geographic area, and the inclusion of pathology test results from multiple pathology laboratories.The evaluation protocol developed reflects the complexity of the Trial setting, the Trial Design and the approach taken within the funding

  19. A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting – rationale, design and baseline characteristics

    Directory of Open Access Journals (Sweden)

    Glastonbury Briony

    2008-08-01

    Full Text Available Abstract Background Point of care testing (PoCT may be a useful adjunct in the management of chronic conditions in general practice (GP. The provision of pathology test results at the time of the consultation could lead to enhanced clinical management, better health outcomes, greater convenience and satisfaction for patients and general practitioners (GPs, and savings in costs and time. It could also result in inappropriate testing, increased consultations and poor health outcomes resulting from inaccurate results. Currently there are very few randomised controlled trials (RCTs in GP that have investigated these aspects of PoCT. Design/Methods The Point of Care Testing in General Practice Trial (PoCT Trial was an Australian Government funded multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost effectiveness and satisfaction of PoCT in a GP setting. The PoCT Trial covered an 18 month period with the intervention consisting of the use of PoCT for seven tests used in the management of patients with diabetes, hyperlipidaemia and patients on anticoagulant therapy. The primary outcome measure was the proportion of patients within target range, a measure of therapeutic control. In addition, the PoCT Trial investigated the safety of PoCT, impact of PoCT on patient compliance to medication, stakeholder satisfaction, cost effectiveness of PoCT versus laboratory testing, and influence of geographic location. Discussion The paper provides an overview of the Trial Design, the rationale for the research methodology chosen and how the Trial was implemented in a GP environment. The evaluation protocol and data collection processes took into account the large number of patients, the broad range of practice types distributed over a large geographic area, and the inclusion of pathology test results from multiple pathology laboratories. The evaluation protocol developed reflects the complexity of the Trial setting

  20. 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

  1. The use of portable video media vs standard verbal communication in the urological consent process: a multicentre, randomised controlled, crossover trial.

    Science.gov (United States)

    Winter, Matthew; Kam, Jonathan; Nalavenkata, Sunny; Hardy, Ellen; Handmer, Marcus; Ainsworth, Hannah; Lee, Wai Gin; Louie-Johnsun, Mark

    2016-11-01

    To determine if portable video media (PVM) improves patient's knowledge and satisfaction acquired during the consent process for cystoscopy and insertion of a ureteric stent compared to standard verbal communication (SVC), as informed consent is a crucial component of patient care and PVM is an emerging technology that may help improve the consent process. In this multi-centre randomised controlled crossover trial, patients requiring cystoscopy and stent insertion were recruited from two major teaching hospitals in Australia over a 15-month period (July 2014-December 2015). Patient information delivery was via PVM and SVC. The PVM consisted of an audio-visual presentation with cartoon animation presented on an iPad. Patient satisfaction was assessed using the validated Client Satisfaction Questionnaire 8 (CSQ-8; maximum score 32) and knowledge was tested using a true/false questionnaire (maximum score 28). Questionnaires were completed after first intervention and after crossover. Scores were analysed using the independent samples t-test and Wilcoxon signed-rank test for the crossover analysis. In all, 88 patients were recruited. A significant 3.1 point (15.5%) increase in understanding was demonstrable favouring the use of PVM (P < 0.001). There was no difference in patient satisfaction between the groups as judged by the CSQ-8. A significant 3.6 point (17.8%) increase in knowledge score was seen when the SVC group were crossed over to the PVM arm. A total of 80.7% of patients preferred PVM and 19.3% preferred SVC. Limitations include the lack of a validated questionnaire to test knowledge acquired from the interventions. This study demonstrates patients' preference towards PVM in the urological consent process of cystoscopy and ureteric stent insertion. PVM improves patient's understanding compared with SVC and is a more effective means of content delivery to patients in terms of overall preference and knowledge gained during the consent process. © 2016 The

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

    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

  3. Catheter Ablation versus Thoracoscopic Surgical Ablation in Long Standing Persistent Atrial Fibrillation (CASA-AF): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Khan, Habib Rehman; Kralj-Hans, Ines; Haldar, Shouvik; Bahrami, Toufan; Clague, Jonathan; De Souza, Anthony; Francis, Darrel; Hussain, Wajid; Jarman, Julian; Jones, David Gareth; Mediratta, Neeraj; Mohiaddin, Raad; Salukhe, Tushar; Jones, Simon; Lord, Joanne; Murphy, Caroline; Kelly, Joanna; Markides, Vias; Gupta, Dhiraj; Wong, Tom

    2018-02-20

    Atrial fibrillation is the commonest arrhythmia which raises the risk of heart failure, thromboembolic stroke, morbidity and death. Pharmacological treatments of this condition are focused on heart rate control, rhythm control and reduction in risk of stroke. Selective ablation of cardiac tissues resulting in isolation of areas causing atrial fibrillation is another treatment strategy which can be delivered by two minimally invasive interventions: percutaneous catheter ablation and thoracoscopic surgical ablation. The main purpose of this trial is to compare the effectiveness and safety of these two interventions. Catheter Ablation versus Thoracoscopic Surgical Ablation in Long Standing Persistent Atrial Fibrillation (CASA-AF) is a prospective, multi-centre, randomised controlled trial within three NHS tertiary cardiovascular centres specialising in treatment of atrial fibrillation. Eligible adults (n = 120) with symptomatic, long-standing, persistent atrial fibrillation will be randomly allocated to either catheter ablation or thoracoscopic ablation in a 1:1 ratio. Pre-determined lesion sets will be delivered in each treatment arm with confirmation of appropriate conduction block. All patients will have an implantable loop recorder (ILR) inserted subcutaneously immediately following ablation to enable continuous heart rhythm monitoring for at least 12 months. The devices will be programmed to detect episodes of atrial fibrillation and atrial tachycardia ≥ 30 s in duration. The patients will be followed for 12 months, completing appropriate clinical assessments and questionnaires every 3 months. The ILR data will be wirelessly transmitted daily and evaluated every month for the duration of the follow-up. The primary endpoint in the study is freedom from atrial fibrillation and atrial tachycardia at the end of the follow-up period. The CASA-AF Trial is a National Institute for Health Research-funded study that will provide first-class evidence on the

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

    Science.gov (United States)

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

    2013-06-26

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

  5. 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

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

    Science.gov (United States)

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

    2017-10-01

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

  7. Rigorous Analysis of a Randomised Number Field Sieve

    OpenAIRE

    Lee, Jonathan; Venkatesan, Ramarathnam

    2018-01-01

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

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

    Science.gov (United States)

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

    2015-08-01

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

  9. 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

  10. 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...

  11. 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. Copyright (c) 2005 S. Karger AG, Basel.

  12. Relevance of randomised controlled trials in oncology.

    Science.gov (United States)

    Tannock, Ian F; Amir, Eitan; Booth, Christopher M; Niraula, Saroj; Ocana, Alberto; Seruga, Bostjan; Templeton, Arnoud J; Vera-Badillo, Francisco

    2016-12-01

    Well-designed randomised controlled trials (RCTs) can prevent bias in the comparison of treatments and provide a sound basis for changes in clinical practice. However, the design and reporting of many RCTs can render their results of little relevance to clinical practice. In this Personal View, we discuss the limitations of RCT data and suggest some ways to improve the clinical relevance of RCTs in the everyday management of patients with cancer. RCTs should ask questions of clinical rather than commercial interest, avoid non-validated surrogate endpoints in registration trials, and have entry criteria that allow inclusion of all patients who are fit to receive treatment. Furthermore, RCTs should be reported with complete accounting of frequency and management of toxicities, and with strict guidelines to ensure freedom from bias. Premature reporting of results should be avoided. The bar for clinical benefit should be raised for drug registration, which should require publication and review of mature data from RCTs, post-marketing health outcome studies, and value-based pricing. Copyright © 2016 Elsevier Ltd. All rights reserved.

  13. 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...

  14. The maturation of randomised controlled trials in mental health ...

    African Journals Online (AJOL)

    The aims of this paper are: (i) to give an overview of the use and maturation of randomised controlled trials (RCTs) in mental health services research, (ii) to indicate areas in which mental health may present particular challenges, and (iii) to outline necessary steps to strengthen the capacity to conduct better quality ...

  15. Affordable moisturisers are effective in atopic eczema: A randomised ...

    African Journals Online (AJOL)

    Background. Many patients depend on moisturisers issued by public health services in the management of atopic dermatitis (AD). Methods. In a randomised controlled trial of patients with mild to moderate AD, aged 1 - 12 years, study 1 compared aqueous cream v. liquid paraffin (fragrance-free baby oil) as a soap substitute ...

  16. A randomised controlled trial of cardiac rehabilitation after revascularisation

    NARCIS (Netherlands)

    Brugemann, Johan; Poels, Bas J. J.; Oosterwijk, Mieke H.; van der Schans, Cees P.; Postema, Klaas; van Veldhuisen, Dirk J.

    Background: It is unclear if psycho- education on top of physical training is of additional value regarding quality of life in revascularised patients. Design: Prospective randomised study comparing two types of cardiac rehabilitation: exercise based versus a more comprehensive approach including

  17. The SafeBoosC Phase II Randomised Clinical Trial

    DEFF Research Database (Denmark)

    Pellicer, Adelina; Greisen, Gorm; Benders, Manon

    2013-01-01

    Near-infrared spectroscopy-derived regional tissue oxygen saturation of haemoglobin (rStO2) reflects venous oxygen saturation. If cerebral metabolism is stable, rStO2 can be used as an estimate of cerebral oxygen delivery. The SafeBoosC phase II randomised clinical trial hypothesises that the bur...

  18. randomised double blind study to compare effectiveness of honey

    African Journals Online (AJOL)

    2014-02-02

    Feb 2, 2014 ... EAsT AFRICAN MEDICAL JOURNAL. February 2014 .... based randomised double- blinded clinical trial evaluating effectiveness of ... study drugs was undertaken following a random ... included sodium citrate, citric acid monohydrate, ... post-hoc test to carry out pair-wise comparisons of .... self-care market.

  19. 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

  20. Randomised controlled trial of mesalazine in IBS.

    Science.gov (United States)

    Barbara, Giovanni; Cremon, Cesare; Annese, Vito; Basilisco, Guido; Bazzoli, Franco; Bellini, Massimo; Benedetti, Antonio; Benini, Luigi; Bossa, Fabrizio; Buldrini, Paola; Cicala, Michele; Cuomo, Rosario; Germanà, Bastianello; Molteni, Paola; Neri, Matteo; Rodi, Marcello; Saggioro, Alfredo; Scribano, Maria Lia; Vecchi, Maurizio; Zoli, Giorgio; Corinaldesi, Roberto; Stanghellini, Vincenzo

    2016-01-01

    Low-grade intestinal inflammation plays a role in the pathophysiology of IBS. In this trial, we aimed at evaluating the efficacy and safety of mesalazine in patients with IBS. We conducted a phase 3, multicentre, tertiary setting, randomised, double-blind, placebo-controlled trial in patients with Rome III confirmed IBS. Patients were randomly assigned to either mesalazine, 800 mg, or placebo, three times daily for 12 weeks, and were followed for additional 12 weeks. The primary efficacy endpoint was satisfactory relief of abdominal pain/discomfort for at least half of the weeks of the treatment period. The key secondary endpoint was satisfactory relief of overall IBS symptoms. Supportive analyses were also performed classifying as responders patients with a percentage of affirmative answers of at least 75% or >75% of time. A total of 185 patients with IBS were enrolled from 21 centres. For the primary endpoint, the responder patients were 68.6% in the mesalazine group versus 67.4% in the placebo group (p=0.870; 95% CI -12.8 to 15.1). In explorative analyses, with the 75% rule or >75% rule, the percentage of responders was greater in the mesalazine group with a difference over placebo of 11.6% (p=0.115; 95% CI -2.7% to 26.0%) and 5.9% (p=0.404; 95% CI -7.8% to 19.4%), respectively, although these differences were not significant. For the key secondary endpoint, overall symptoms improved in the mesalazine group and reached a significant difference of 15.1% versus placebo (p=0.032; 95% CI 1.5% to 28.7%) with the >75% rule. Mesalazine treatment was not superior than placebo on the study primary endpoint. However, a subgroup of patients with IBS showed a sustained therapy response and benefits from a mesalazine therapy. ClincialTrials.gov number, NCT00626288. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  1. 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

  2. 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

  3. Ballistic strength training compared with usual care for improving mobility following traumatic brain injury: protocol for a randomised, controlled trial.

    Science.gov (United States)

    Williams, Gavin; Ada, Louise; Hassett, Leanne; Morris, Meg E; Clark, Ross; Bryant, Adam L; Olver, John

    2016-07-01

    Traumatic brain injury is the leading cause of disability in young adults aged 15 to 45 years. Mobility limitations are prevalent, and range in severity from interfering with basic day-to-day tasks to restricting participation in higher level social, leisure, employment and sporting activities. Despite the prevalence and severity of physical impairments, such as poor balance and spasticity, the main contributor to mobility limitations following traumatic brain injury is low muscle power generation. Strengthening exercises that are performed quickly are termed 'ballistic' as they are aimed at improving the rate of force production and, hence, muscle power. This is compared with conventional strength training, which is performed slowly and aims to improve maximum force production, yet has limited impact on mobility. In people recovering from traumatic brain injury: (1) is a 12-week ballistic strength-training program targeting the three muscle groups critical for walking more effective than usual care at improving mobility, strength and balance; and (2) does improved mobility translate to better health-related quality of life? A prospective, multi-centre, randomised, single-blind trial with concealed allocation will be conducted. Participants will be patients with a neurologically based movement disorder affecting mobility as a result of traumatic brain injury. Patients will be recruited during the acute phase of rehabilitation (n=166), from brain injury units in large metropolitan hospitals in Melbourne and Sydney, Australia. For 12 weeks, participants in the experimental group will have three 60-minute sessions of usual physiotherapy intervention replaced by three 60-minute sessions of strength training (ballistic strength, gait). The three key muscle groups responsible for forward propulsion will be targeted: ankle plantarflexors, hip flexors and the hip extensors. Initial loads will be low, to facilitate high contraction velocities. Progression to higher loads

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

    Directory of Open Access Journals (Sweden)

    Stephanie J C Taylor

    2016-06-01

    Full Text Available 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.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, accounted for clustering by course

  5. Group art therapy as an adjunctive treatment for people with schizophrenia: a randomised controlled trial (MATISSE).

    OpenAIRE

    Crawford, MJ; Killaspy, H; Barnes, TR; Barrett, B; Byford, S; Clayton, K; Dinsmore, J; Floyd, S; Hoadley, A; Johnson, T; Kalaitzaki, E; King, M; Leurent, B; Maratos, A; O'Neill, FA

    2012-01-01

    OBJECTIVE To examine the clinical effectiveness and cost-effectiveness of referral to group art therapy plus standard care, compared with referral to an activity group plus standard care and standard care alone, among people with schizophrenia. DESIGN A three-arm, parallel group, single-blind, pragmatic, randomised controlled trial. Participants were randomised via an independent and remote telephone randomisation service using permuted blocks, stratified by study centre. SETTING Study partic...

  6. Reported challenges in nurse-led randomised controlled trials

    DEFF Research Database (Denmark)

    Wang Vedelø, Tina; Lomborg, Kirsten

    2011-01-01

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

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

    Science.gov (United States)

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

    2018-06-01

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

  8. Psychological rehabilitation after myocardial infarction: multicentre randomised controlled trial.

    OpenAIRE

    Jones, D. A.; West, R. R.

    1996-01-01

    OBJECTIVE: To evaluate rehabilitation after myocardial infarction. DESIGN: Randomised controlled trial of rehabilitation in unselected myocardial infarction patients in six centres, baseline data being collected on admission and by structured interview (of patients and spouses) shortly after discharge and outcome being assessed by structured interview at six months and clinical examination at 12 months. SETTING: Six district general hospitals. SUBJECTS: All 2328 eligible patients admitted ove...

  9. A randomised controlled trial of complete denture impression materials.

    Science.gov (United States)

    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; Brown, S; Dukanovic, G; Brunton, P A

    2014-08-01

    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. Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7-67.3%, pUnilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  10. Attachment Styles of Dermatological Patients in Europe: A Multi-centre Study in 13 Countries.

    Science.gov (United States)

    Szabó, Csanád; Altmayer, Anita; Lien, Lars; Poot, Françoise; Gieler, Uwe; Tomas-Aragones, Lucía; Kupfer, Jörg; Jemec, Gregor B E; Misery, Laurent; Linder, M Dennis; Sampogna, Francesca; van Middendorp, Henriët; Halvorsen, Jon Anders; Balieva, Flora; Szepietowski, Jacek C; Romanov, Dmitry; Marron, Servando E; Altunay, Ilknur K; Finlay, Andrew Y; Salek, Sam S; Dalgard, Florence

    2017-07-06

    Attachment styles of dermatological outpatients and satisfaction with their dermatologists were investigated within the framework of a multicentre study conducted in 13 European countries, organized by the European Society for Dermatology and Psychiatry. Attachment style was assessed with the Adult Attachment Scale. Patient satisfaction with the dermatologist was assessed with an 11-degree scale. A total of 3,635 adult outpatients and 1,359 controls participated in the study. Dermatological outpatients were less able to depend on others, were less comfortable with closeness and intimacy, and experienced similar rates of anxiety in relationships as did the controls. Participants who had secure attachment styles reported stressful life events during the last 6 months significantly less often than those who had insecure attachment styles. Patients with secure attachment styles tended to be more satisfied with their dermatologist than did insecure patients. These results suggest that secure attachment of dermatological outpatients may be a protective factor in the management of stress.

  11. European multi-centre study of the Nucleus Hybrid L24 cochlear implant

    NARCIS (Netherlands)

    Lenarz, T.; James, C.; Cuda, D.; Fitzgerald O'Connor, A.; Frachet, B.; Frijns, J.H.M.; Klenzner, T.; Laszig, R.; Manrique, M.; Marx, M.; Merkus, P.; Mylanus, E.A.M.; Offeciers, E.; Pesch, J.; Ramos-Macias, A.; Robier, A.; Sterkers, O.; Uziel, A.

    2013-01-01

    Objectives: To investigate the preservation of residual hearing in subjects who received the Nucleus Hybrid L24 cochlear implant. To investigate the performance benefits up to one year post-implantation in terms of speech recognition, sound quality, and quality of life. Design: Prospective, with

  12. Diabetic retinopathy screening in New Zealand requires improvement: results from a multi-centre audit.

    Science.gov (United States)

    Hutchins, Edward; Coppell, Kirsten J; Morris, Ainsley; Sanderson, Gordon

    2012-06-01

    To determine whether diabetic retinal screening services and retinopathy referral centres in New Zealand meet the national guidelines for referral and assessment of screen detected moderate retinal and mild macular diabetic eye disease. Diabetic retinal screening pathways and the data collected at four main centre retinal screening services were described and compared with recommendations in the national diabetes retinal screening guidelines. A retrospective audit of photoscreen detected moderate retinopathy (grade R3), and mild maculopathy (grades M2B and M3) during May to August 2008 was undertaken. Data collected by retinopathy referral centres were used to examine the follow-up of screen detected cases and to make comparisons with the national recommendations. All four screening services used the guidelines for grading, but the recommended dataset was incomplete. Not all recorded data were readily accessible. The retinal photos of 157 (2.4%) patients were graded as R3, M2B, M3 or a combination. The proportion of those screened with these grades varied across the four centres from 1.2% to 3.4%. Follow-up of the 157 screen positive patients did not always comply with guideline recommendations. Seventy five (48%) were referred for review by an ophthalmologist as recommended, 45 (60% of referred) were seen within the recommended six months. Nine patients (15% of the 60 with a documented assessment) were referred for or received laser treatment at 12-months follow-up. Quality diabetic retinal screening data systems and quality assurance programs are required to improve the monitoring and quality of retinal screening in New Zealand. © 2012 The Authors. ANZJPH © 2012 Public Health Association of Australia.

  13. Experience and outcome of ventricular-atrial shunt: a multi centre study

    International Nuclear Information System (INIS)

    Akhtar, N.; Khan, A.A.; Yousaf, M.

    2015-01-01

    Ventriculoperitoneal (VP) shunt has been widely utilized in the treatment of hydrocephalus as a safe option but there is recent literature evidence that ventricularatrial (VA) shunt is not as notorious for its complications as proclaimed, to analyse and report our success with this procedure we conducted our study. Methods: A total of 64 patients undergoing VA shunting were included in this case series study conducted at RMC and Allied hospital Rawalpindi. The data was collected over a period of 4 years from, 1st June 2010 to 1st June 2015. Result: Our study included 64 patients who underwent a VA shunt for hydrocephalus. Their age ranged from 25 to 75 years. Most of the patients were females (60%). The following complications were observed with 2 (3.12%) patients having blockage of the shunt at the neck, 3 (4.68%) suffered from glomerulonephritis, 2 (3.1%) had post-operative neck hematoma, 4 (6.25 %) had wound infection, short lower end of the tube was found in 3 (4.68%), migrated lower end (into the subclavian) was seen in 1 (1.56%). Mortality was 1(1.56%). These results were comparable to other studies. Conclusion: Neurosurgeons have been doing a VA shunt as a second procedure, after a VP shunt when the need due to a complication was encountered. We however share our experience regarding ventriculo-atrial shunting, as first choice procedure, because of its low incidence of shunt blockage unlike VP shunt, which has high rate of shunt blockage and therefore warrants repeated surgeries. (author)

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

    DEFF Research Database (Denmark)

    Shinn, A.P.; Collins, C.; García-Vásquez, A.

    2010-01-01

    Tilgængelige metoder til diagnose af G. salaris er blevet afprøvet i en række laboratorier Udgivelsesdato: September......Tilgængelige metoder til diagnose af G. salaris er blevet afprøvet i en række laboratorier Udgivelsesdato: September...

  15. 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.

  16. The diagnostic and therapeutic impact of MRI: an observational multi-centre study

    Energy Technology Data Exchange (ETDEWEB)

    Hollingworth, William; Todd, Christopher J.; Bell, Matthew I.; Arafat, Qais; Girling, Simon; Karia, Kanti R.; Dixon, Adrian K

    2000-11-01

    AIM: To provide information about the diagnostic and therapeutic impact of magnetic resonance imaging (MRI) and to compare the findings across diagnostic groups. MATERIALS AND METHODS: A prospective, observational study of 2017 consecutive referrals for MRI of the head, spine or knee at four imaging centres. Clinicians completed questionnaires before MRI stating initial diagnoses, diagnostic confidence and treatment plans. After imaging, a second questionnaire evaluated clinicians' revised diagnosis and treatment plans in the light of imaging findings. Patients were grouped into nine diagnostic categories for analysis. Comparison between pre- and post-imaging was used to assess the diagnostic and therapeutic impact of MRI. RESULTS: In seven of nine diagnostic groups MRI findings were associated with a diagnostic impact. Diagnoses were revised or discarded following normal MR findings and diagnostic confidence was increased by confirmative MR findings. There was no statistically significant diagnostic impact for suspected pituitary or cerebello-pontine angle lesions. In five of nine diagnostic groups (knee meniscus, knee ligament, multiple sclerosis, lumbar and cervical spine) MRI findings had a clear impact on treatment plans. CONCLUSION: This study demonstrates that in most diagnostic categories, MRI influences diagnosis and treatment. However, experimental studies are needed to prove that these diagnostic and therapeutic impacts lead to improved health. Hollingworth (2000)

  17. 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

    nulliparous women in term spontaneous labour with a singleton infant in cephalic presentation. Data were collected by self-administered questionnaires and clinical data-records. Logistic regression analyses were used to estimate adjusted Odds Ratios (OR) and 95% confidence intervals (CI) are given. RESULTS......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......: The following characteristics, present at admission to hospital, were associated with dystocia during labour (OR, 95% CI): dilatation of cervix

  18. Single-course specific immunotherapy with mixed pollen allergoids: results of a multi-centre study.

    Science.gov (United States)

    Drachenberg, K J; Pröll, S; Urban, E; Woroniecki, S R

    2003-01-01

    A short-term immunotherapy vaccine for the treatment of pollen allergy has been developed utilising L-tyrosine adsorbed allergoids. The reduced number of injections could provide advantages over long-term therapy schedules. This would improve compliance and support application of specific immunotherapy (SIT) to a greater extent. We report a multicenter study to evaluate the efficacy and safety of this treatment in a clinical practice setting. Patients (n = 1808) with a diagnosis of sensitivities to various pollens and symptoms of allergic asthma and/or allergic rhinitis and/or allergic conjunctivitis were selected. The vaccine formulation was made up according to individual sensitivities and contained L-tyrosine adsorbed allergoids. The patients were treated with a 3-injection initial course followed by a 3-injection maintenance course. Efficacy was measured by consumption of symptomatic anti-allergic medication compared with that in the previous season and by physician assessment using a 5-point scale. All adverse events were recorded. Efficacy was demonstrated by a considerable decrease in regular and frequent use of medication compared with that in the previous season (p allergoid/L-tyrosine vaccine in a clinical practice setting provided a high level of efficacy with a low incidence of mainly mild adverse events.

  19. 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...

  20. The diagnostic and therapeutic impact of MRI: an observational multi-centre study

    International Nuclear Information System (INIS)

    Hollingworth, William; Todd, Christopher J.; Bell, Matthew I.; Arafat, Qais; Girling, Simon; Karia, Kanti R.; Dixon, Adrian K.

    2000-01-01

    AIM: To provide information about the diagnostic and therapeutic impact of magnetic resonance imaging (MRI) and to compare the findings across diagnostic groups. MATERIALS AND METHODS: A prospective, observational study of 2017 consecutive referrals for MRI of the head, spine or knee at four imaging centres. Clinicians completed questionnaires before MRI stating initial diagnoses, diagnostic confidence and treatment plans. After imaging, a second questionnaire evaluated clinicians' revised diagnosis and treatment plans in the light of imaging findings. Patients were grouped into nine diagnostic categories for analysis. Comparison between pre- and post-imaging was used to assess the diagnostic and therapeutic impact of MRI. RESULTS: In seven of nine diagnostic groups MRI findings were associated with a diagnostic impact. Diagnoses were revised or discarded following normal MR findings and diagnostic confidence was increased by confirmative MR findings. There was no statistically significant diagnostic impact for suspected pituitary or cerebello-pontine angle lesions. In five of nine diagnostic groups (knee meniscus, knee ligament, multiple sclerosis, lumbar and cervical spine) MRI findings had a clear impact on treatment plans. CONCLUSION: This study demonstrates that in most diagnostic categories, MRI influences diagnosis and treatment. However, experimental studies are needed to prove that these diagnostic and therapeutic impacts lead to improved health. Hollingworth (2000)

  1. 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 elec